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["5ecbf3b2feab101b155307b0","NCT03387215","2018-01-02","Intra-Cellular Therapies","ITCI","Not yet recruiting","Randomized, Double-Blind, Placebo-Controlled, Safety and Tolerability Study of ITI-214 in Patients With Heart Failure","Iti-214",null,"Yes","['Iti-214']","Unknown",null,"Phase 1/Phase 2",4,36,"Anticipated","2018-01-01","2019-07-01",{"$nulls":5},"This is a Phase I/II randomized, double-blind, placebo-controlled, single rising dose study in patients with systolic heart failure to evaluate the safety and tolerability of ITI-214.",null,"Randomized, Double-Blind, Placebo-Controlled, Safety and Tolerability Study of Escalating Single Doses of ITI-214 in Patients With Systolic Heart Failure","ITI-214-104","Heart Failure, Systolic","Heart Failure|Heart Failure, Systolic|Heart Failure, Chronic","Heart Diseases","Cardiovascular","Experimental|Placebo Comparator","10 mg ITI-214|30 mg ITI-214|75 mg - 150 mg ITI-214|Placebo","Single oral dose","Drug","ITI-214|Placebo","Oral",null,"10 mg ITI-214|30 mg ITI-214|75 mg - 150 mg ITI-214|Placebo","\n\n * NYHA class II-III heart failure\n * Ejection fraction equal to or below 35%\n * On stable heart failure drug treatment\n\n","\n\n * Considered medically inappropriate for study participation",{"$nulls":4},"Actual","2018-01-02","Actual","Anticipated","2019-07-01","Anticipated","2017-12-01","2017-12-18","2017-12-21","2017-12-21",null,null,"Interventional","Treatment","Sequential Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years","80 Years","All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":19},"Echocardiogram with Doppler imaging and hemodynamic monitoring","Cardiac systolic and diastolic function","2 hours","12-lead electrocardiogram (ECG)|Hemodynamic monitoring|Number of patients with treatment-emergent adverse events|Other Pre-specified Outcome Measures:|Plasma and urine levels of cAMP and cGMP as Exploratory biomarkers","Safety and tolerability|Cardiac systolic and diastolic function|Other Pre-specified Outcome Measures:|Pharmacodynamics","2 hours|5-6 hours|5 days","itciclinicaltrials@intracellulartherapies.com","Kimberly Vanover, PhD","646-440-9333","Baltimore, Maryland, United States, 21287Principal Investigator: Nisha Gilotra, Md|Durham, North Carolina, United States, 27710","Maryland|North Carolina","United States","Johns Hopkins University|Duke Clinical Research Institute",{"$nulls":4},"2017-12-21","2020-05-25T16:34:58.154","2020-05-26T17:10:42.972","NCT03387215"]
["5ecbf3b2fe30261b1a048180","NCT03387215","2018-07-26","Intra-Cellular Therapies","ITCI","Recruiting","Randomized, Double-Blind, Placebo-Controlled, Safety and Tolerability Study of ITI-214 in Patients With Heart Failure","Iti-214",null,"Yes","['Iti-214']","Unknown",null,"Phase 1/Phase 2",4,36,"Anticipated","2018-07-10","2019-12-01",{"$nulls":5},"This is a Phase I/II randomized, double-blind, placebo-controlled, single rising dose study in patients with systolic heart failure to evaluate the safety and tolerability of ITI-214.",null,"Randomized, Double-Blind, Placebo-Controlled, Safety and Tolerability Study of Escalating Single Doses of ITI-214 in Patients With Systolic Heart Failure","ITI-214-104","Heart Failure, Systolic","Heart Failure|Heart Failure, Systolic|Heart Failure, Chronic","Heart Diseases","Cardiovascular","Experimental|Placebo Comparator","10 mg ITI-214|30 mg ITI-214|75 mg - 150 mg ITI-214|Placebo","Single oral dose","Drug","ITI-214|Placebo","Oral",null,"10 mg ITI-214|30 mg ITI-214|75 mg - 150 mg ITI-214|Placebo","\n\n * NYHA class II-III heart failure\n * Ejection fraction equal to or below 35%\n * On stable heart failure drug treatment\n\n","\n\n * Considered medically inappropriate for study participation",{"$nulls":4},"Actual","2018-01-02","Actual","Anticipated","2019-12-01","Anticipated","2018-07-01","2017-12-18","2017-12-21","2018-07-24",null,null,"Interventional","Treatment","Sequential Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years","80 Years","All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":19},"Echocardiogram with Doppler imaging and hemodynamic monitoring","Cardiac systolic and diastolic function","2 hours","12-lead electrocardiogram (ECG)|Hemodynamic monitoring|Number of patients with treatment-emergent adverse events|Other Pre-specified Outcome Measures:|Plasma and urine levels of cAMP and cGMP as Exploratory biomarkers","Safety and tolerability|Cardiac systolic and diastolic function|Other Pre-specified Outcome Measures:|Pharmacodynamics","2 hours|5-6 hours|5 days","itciclinicaltrials@intracellulartherapies.com","Kimberly Vanover, PhD","646-440-9333","Baltimore, Maryland, United States, 21287Principal Investigator: Nisha Gilotra, Md|Durham, North Carolina, United States, 27710","Maryland|North Carolina","United States","Johns Hopkins University|Duke Clinical Research Institute",{"$nulls":4},"2018-07-24","2020-05-25T16:34:58.580","2020-05-26T17:10:42.972","NCT03387215"]
["5ecbf3b2e2561b1b11905c7b","NCT03387215","2019-08-12","Intra-Cellular Therapies","ITCI","Recruiting","Randomized, Double-Blind, Placebo-Controlled, Safety and Tolerability Study of ITI-214 in Patients With Heart Failure","Iti-214",null,"Yes","['Iti-214']","Unknown",null,"Phase 1/Phase 2",4,36,"Anticipated","2018-07-10","2019-12-01",{"$nulls":5},"This is a Phase I/II randomized, double-blind, placebo-controlled, single rising dose study in patients with systolic heart failure to evaluate the safety and tolerability of ITI-214.",null,"Randomized, Double-Blind, Placebo-Controlled, Safety and Tolerability Study of Escalating Single Doses of ITI-214 in Patients With Systolic Heart Failure","ITI-214-104","Heart Failure, Systolic","Heart Failure|Heart Failure, Systolic|Heart Failure, Chronic","Heart Diseases","Cardiovascular","Experimental|Placebo Comparator","10 mg ITI-214|30 mg ITI-214|75 mg - 150 mg ITI-214|Placebo","Single oral dose","Drug","ITI-214|Placebo","Oral",null,"10 mg ITI-214|30 mg ITI-214|75 mg - 150 mg ITI-214|Placebo","\n\n * NYHA class II-III heart failure\n * Ejection fraction equal to or below 35%\n * On stable heart failure drug treatment\n\n","\n\n * Considered medically inappropriate for study participation",{"$nulls":4},"Actual","2018-01-02","Actual","Anticipated","2019-12-01","Anticipated","2019-08-01","2017-12-18","2017-12-21","2019-08-09",null,null,"Interventional","Treatment","Sequential Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years","80 Years","All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":19},"Echocardiogram with Doppler imaging and hemodynamic monitoring","Cardiac systolic and diastolic function","2 hours","12-lead electrocardiogram (ECG)|Hemodynamic monitoring|Number of patients with treatment-emergent adverse events|Other Pre-specified Outcome Measures:|Plasma and urine levels of cAMP and cGMP as Exploratory biomarkers","Safety and tolerability|Cardiac systolic and diastolic function|Other Pre-specified Outcome Measures:|Pharmacodynamics","2 hours|5-6 hours|5 days","itciclinicaltrials@intracellulartherapies.com","Kimberly Vanover, PhD","646-440-9333","Baltimore, Maryland, United States, 21287Principal Investigator: Nisha Gilotra, Md|Durham, North Carolina, United States, 27710","Maryland|North Carolina","United States","Johns Hopkins University|Duke Clinical Research Institute",{"$nulls":4},"2019-08-09","2020-05-25T16:34:58.143","2020-05-26T17:10:42.972","NCT03387215"]
["5ecbf3b4fe30261b1a048186","NCT03387657","2018-01-02","Sanofi","SNY","Recruiting","A Drug to Drug Interaction Study of Sotagliflozin With Hydrochlorothiazide","Sotagliflozin|Hydrochlorothiazide","SGLT1 Inhibitor|SGLT2 Inhibitor|NCCT Inhibitor","Yes","['Sotagliflozin']","Yes","['SGLT1 Inhibitor']","Phase 1",1,16,"Anticipated","2017-12-08","2018-03-01","AUC","Area Under The Curve",{"$nulls":3},"Primary Objective:\n\nTo assess the effects of multiple-dose hydrochlorothiazide (HCTZ) on the steady-state pharmacokinetics (PK) of sotagliflozin.\n\nSecondary Objectives:\n\n * To assess the safety and tolerability of multiple-dose sotagliflozin with and without co-administration of multiple-dose HCTZ\n * To assess the effects of multiple-dose sotagliflozin on the steady-state PK of HCTZ\n * To assess the effects of multiple-dose HCTZ on the steady-state PK of sotagliflozin-3-O-glucuronide","Duration of the study for each subject will be between 33 to 77 days, including screening up to 28 days, 5 days of treatment Period 1, washout period of 7-21 days, 9 days of treatment Period 2, and follow-up period of 10-14 days after last dose of the Investigational Medicinal Product (IMP) in Period 2.","A Phase 1, Single-Center, Open-Label, Two-Period, Single-Sequence, Multiple Dosing Drug-Drug Interaction Study of Sotagliflozin and Hydrochlorothiazide in Healthy Male and Female Subjects","INT14905","Type 2 Diabetes Mellitus","Type 2 Diabetes","Metabolic Diseases","Nutritional Disorders","Experimental","Sotagliflozin + Hydrochlorothiazide (HCTZ)","Sotagliflozin to be administered alone in Period 1. HCTZ to be given in Period 2 for 4 days followed immediately by HCTZ and sotagliflozin for 5 days.","Drug","Sotagliflozin (SAR439954)|Hydrochlorothiazide",null,null,"Sotagliflozin + Hydrochlorothiazide (HCTZ)"," * Male or female subjects, between 18 and 55 years of age, inclusive.\n * Body weight between 50.0 and 100.0 kg, inclusive, if male, and between 40.0 and 90.0 kg, inclusive, if female, body mass index between 18.0 and 30.0 kg/m2, inclusive.\n * Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination).\n * Normal vital signs, electrocardiogram, and laboratory parameters.\n * Female subject must use a double contraception method including a highly effective method of birth control, except if she has undergone sterilization at least 3 months earlier or is postmenopausal. The accepted double contraception methods include the use of 1 of the following contraceptive options: (1) intrauterine device; (2) condom or diaphragm or cervical/vault cap, in addition to spermicide. Menopause is defined as being amenorrheic for at least 2 years with plasma follicle stimulating hormone level >30 IU. Hormonal contraception is NOT acceptable in this study.\n * Male subject, whose partners are of childbearing potential (including lactating women), must accept to use, during sexual intercourse, a double contraception method according to the following algorithm: (condom) plus (spermicide or intra-uterine device or hormonal contraceptive) from the inclusion up to 4 months after the last dosing.\n * Male subject, whose partners are pregnant, must use, during sexual intercourse, a condom from the inclusion up to 4 months after the last dosing.\n * Male subject has agreed not to donate sperm from the inclusion up to 4 months after the last dosing.\n\n"," * Any medication (including St John's Wort) within 14 days before inclusion or within 5 times the elimination half-life or pharmacodynamic half-life of the medication, with the exception of hormonal contraception or menopausal hormone replacement therapy; any vaccination within the last 28 days and any biologics (antibody or its derivatives) given within 4 months before inclusion.\n * Positive result on any of the following tests: hepatitis B surface (HBs Ag) antigen, anti-hepatitis C virus (anti-HCV) antibodies, anti-human immunodeficiency virus 1 and 2 antibodies (anti-HIV1 and anti HIV2 Ab).\n * Positive result on urine drug screen or alcohol test.\n * Any contra-indications to hydrochlorothiazide, according to the applicable labeling.\n * Any history or presence of deep leg vein thrombosis or embolism or a recurrent or frequent appearance of deep leg vein thrombosis in first degree relatives (parents, siblings or children).\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial. ",{"$nulls":4},"Actual","2018-01-02","Actual","Anticipated","2018-03-01","Anticipated","2017-12-01","2017-12-20","2017-12-22","2017-12-22","No",null,"Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","18 Years","55 Years","All",null,"Yes","Yes\nQualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://www.clinicalstudydatarequest.com/",{"$nulls":3},"Yes","No",{"$nulls":17},"U1111-1186-2718","UTN","Assessment of PK parameter: AUCtau","Sotagliflozin without HCTZ: AUC to the end of the dosing period (AUCtau)|Sotagliflozin with HCTZ: AUCtau","Period 1, days 2 to 6|Period 2, days 6 to 10","Assessment of PK parameter: AUCtau|Assessment of PK parameter: Cmax|Assessment of PK parameter: tmax","HCTZ without sotagliflozin: AUCtau|HCTZ with sotagliflozin: AUCtau|Sotagliflozin-3-O-glucuronide without HCTZ: AUCtau|Sotagliflozin-3-O-glucuronide with HCTZ: AUCtau|HCTZ without sotagliflozin: Maximum plasma concentration (Cmax)|HCTZ with sotagliflozin: Cmax|Sotagliflozin-3-O-glucuronide without HCTZ: Cmax|Sotagliflozin-3-O-glucuronide with HCTZ: Cmax|HCTZ without sotagliflozin: Time to reach Cmax (tmax)|HCTZ with sotagliflozin: tmax|Sotagliflozin-3-O-glucuronide without HCTZ: tmax|Sotagliflozin-3-O-glucuronide with HCTZ: tmax|Sotagliflozin without HCTZ: Cmax|Sotagliflozin with HCTZ: Cmax|Sotagliflozin without HCTZ: tmax|Sotagliflozin with HCTZ: tmax","Period 2, days 4 to 5|Period 2, days 9 to 10|Period 1, days 2 to 6|Period 2, days 6 to 10","Contact-Us@sanofi.com","For site information, send an email with site number to",null,"Dallas, Texas, United States, 75247","Texas","United States","Investigational Site Number 8400001",{"$nulls":3},"Clinical Sciences & Operations","2017-12-22","2020-05-25T16:35:00.901","2020-05-26T17:10:42.972","NCT03387657"]
["5ecbf3b4307e3d1b1f8d9c16","NCT03387657","2018-01-11","Sanofi","SNY","Recruiting","A Drug to Drug Interaction Study of Sotagliflozin With Hydrochlorothiazide","Sotagliflozin|Hydrochlorothiazide","SGLT1 Inhibitor|SGLT2 Inhibitor|NCCT Inhibitor","Yes","['Sotagliflozin']","Yes","['SGLT1 Inhibitor']","Phase 1",1,16,"Anticipated","2017-12-08","2018-03-01","AUC","Area Under The Curve",{"$nulls":3},"Primary Objective:\n\nTo assess the effects of multiple-dose hydrochlorothiazide (HCTZ) on the steady-state pharmacokinetics (PK) of sotagliflozin.\n\nSecondary Objectives:\n\n * To assess the safety and tolerability of multiple-dose sotagliflozin with and without co-administration of multiple-dose HCTZ\n * To assess the effects of multiple-dose sotagliflozin on the steady-state PK of HCTZ\n * To assess the effects of multiple-dose HCTZ on the steady-state PK of sotagliflozin-3-O-glucuronide","Duration of the study for each subject will be between 33 to 77 days, including screening up to 28 days, 5 days of treatment Period 1, washout period of 7-21 days, 9 days of treatment Period 2, and follow-up period of 10-14 days after last dose of the Investigational Medicinal Product (IMP) in Period 2.","A Phase 1, Single-Center, Open-Label, Two-Period, Single-Sequence, Multiple Dosing Drug-Drug Interaction Study of Sotagliflozin and Hydrochlorothiazide in Healthy Male and Female Subjects","INT14905","Type 2 Diabetes Mellitus","Type 2 Diabetes","Metabolic Diseases","Nutritional Disorders","Experimental","Sotagliflozin + Hydrochlorothiazide (HCTZ)","Sotagliflozin to be administered alone in Period 1. HCTZ to be given in Period 2 for 4 days followed immediately by HCTZ and sotagliflozin for 5 days.","Drug","Sotagliflozin (SAR439954)|Hydrochlorothiazide",null,null,"Sotagliflozin + Hydrochlorothiazide (HCTZ)"," * Male or female subjects, between 18 and 55 years of age, inclusive.\n * Body weight between 50.0 and 100.0 kg, inclusive, if male, and between 40.0 and 90.0 kg, inclusive, if female, body mass index between 18.0 and 30.0 kg/m2, inclusive.\n * Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination).\n * Normal vital signs, electrocardiogram, and laboratory parameters.\n * Female subject must use a double contraception method including a highly effective method of birth control, except if she has undergone sterilization at least 3 months earlier or is postmenopausal. The accepted double contraception methods include the use of 1 of the following contraceptive options: (1) intrauterine device; (2) condom or diaphragm or cervical/vault cap, in addition to spermicide. Menopause is defined as being amenorrheic for at least 2 years with plasma follicle stimulating hormone level >30 IU. Hormonal contraception is NOT acceptable in this study.\n * Male subject, whose partners are of childbearing potential (including lactating women), must accept to use, during sexual intercourse, a double contraception method according to the following algorithm: (condom) plus (spermicide or intra-uterine device or hormonal contraceptive) from the inclusion up to 4 months after the last dosing.\n * Male subject, whose partners are pregnant, must use, during sexual intercourse, a condom from the inclusion up to 4 months after the last dosing.\n * Male subject has agreed not to donate sperm from the inclusion up to 4 months after the last dosing.\n\n"," * Any medication (including St John's Wort) within 14 days before inclusion or within 5 times the elimination half-life or pharmacodynamic half-life of the medication, with the exception of hormonal contraception or menopausal hormone replacement therapy; any vaccination within the last 28 days and any biologics (antibody or its derivatives) given within 4 months before inclusion.\n * Positive result on any of the following tests: hepatitis B surface (HBs Ag) antigen, anti-hepatitis C virus (anti-HCV) antibodies, anti-human immunodeficiency virus 1 and 2 antibodies (anti-HIV1 and anti HIV2 Ab).\n * Positive result on urine drug screen or alcohol test.\n * Any contra-indications to hydrochlorothiazide, according to the applicable labeling.\n * Any history or presence of deep leg vein thrombosis or embolism or a recurrent or frequent appearance of deep leg vein thrombosis in first degree relatives (parents, siblings or children).\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial. ",{"$nulls":4},"Actual","2018-01-02","Actual","Anticipated","2018-03-01","Anticipated","2018-01-01","2017-12-20","2017-12-22","2018-01-10","No",null,"Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","18 Years","55 Years","All",null,"Yes","Yes\nQualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://www.clinicalstudydatarequest.com/",{"$nulls":3},"Yes","No",{"$nulls":17},"U1111-1186-2718","UTN","Assessment of PK parameter: AUCtau","Sotagliflozin without HCTZ: AUC to the end of the dosing period (AUCtau)|Sotagliflozin with HCTZ: AUCtau","Period 1, days 2 to 6|Period 2, days 6 to 10","Assessment of PK parameter: AUCtau|Assessment of PK parameter: Cmax|Assessment of PK parameter: tmax","HCTZ without sotagliflozin: AUCtau|HCTZ with sotagliflozin: AUCtau|Sotagliflozin-3-O-glucuronide without HCTZ: AUCtau|Sotagliflozin-3-O-glucuronide with HCTZ: AUCtau|HCTZ without sotagliflozin: Maximum plasma concentration (Cmax)|HCTZ with sotagliflozin: Cmax|Sotagliflozin-3-O-glucuronide without HCTZ: Cmax|Sotagliflozin-3-O-glucuronide with HCTZ: Cmax|HCTZ without sotagliflozin: Time to reach Cmax (tmax)|HCTZ with sotagliflozin: tmax|Sotagliflozin-3-O-glucuronide without HCTZ: tmax|Sotagliflozin-3-O-glucuronide with HCTZ: tmax|Sotagliflozin without HCTZ: Cmax|Sotagliflozin with HCTZ: Cmax|Sotagliflozin without HCTZ: tmax|Sotagliflozin with HCTZ: tmax","Period 2, days 4 to 5|Period 2, days 9 to 10|Period 1, days 2 to 6|Period 2, days 6 to 10","Contact-Us@sanofi.com","For site information, send an email with site number to",null,"Dallas, Texas, United States, 75247","Texas","United States","Investigational Site Number 8400001",{"$nulls":3},"Clinical Sciences & Operations","2018-01-10","2020-05-25T16:35:00.959","2020-05-26T17:10:42.972","NCT03387657"]
["5ecbf3b5feab101b155307b7","NCT03387657","2018-01-30","Sanofi","SNY","Recruiting","A Drug to Drug Interaction Study of Sotagliflozin With Hydrochlorothiazide","Sotagliflozin|Hydrochlorothiazide","SGLT1 Inhibitor|SGLT2 Inhibitor|NCCT Inhibitor","Yes","['Sotagliflozin']","Yes","['SGLT1 Inhibitor']","Phase 1",1,16,"Anticipated","2017-12-08","2018-03-01","AUC","Area Under The Curve",{"$nulls":3},"Primary Objective:\n\nTo assess the effects of multiple-dose hydrochlorothiazide (HCTZ) on the steady-state pharmacokinetics (PK) of sotagliflozin.\n\nSecondary Objectives:\n\n * To assess the safety and tolerability of multiple-dose sotagliflozin with and without co-administration of multiple-dose HCTZ\n * To assess the effects of multiple-dose sotagliflozin on the steady-state PK of HCTZ\n * To assess the effects of multiple-dose HCTZ on the steady-state PK of sotagliflozin-3-O-glucuronide","Duration of the study for each subject will be between 33 to 77 days, including screening up to 28 days, 5 days of treatment Period 1, washout period of 7-21 days, 9 days of treatment Period 2, and follow-up period of 10-14 days after last dose of the Investigational Medicinal Product (IMP) in Period 2.","A Phase 1, Single-Center, Open-Label, Two-Period, Single-Sequence, Multiple Dosing Drug-Drug Interaction Study of Sotagliflozin and Hydrochlorothiazide in Healthy Male and Female Subjects","INT14905","Type 2 Diabetes Mellitus","Type 2 Diabetes","Metabolic Diseases","Nutritional Disorders","Experimental","Sotagliflozin + Hydrochlorothiazide (HCTZ)","Sotagliflozin to be administered alone in Period 1. HCTZ to be given in Period 2 for 4 days followed immediately by HCTZ and sotagliflozin for 5 days.","Drug","Sotagliflozin (SAR439954)|Hydrochlorothiazide",null,null,"Sotagliflozin + Hydrochlorothiazide (HCTZ)"," * Male or female subjects, between 18 and 55 years of age, inclusive.\n * Body weight between 50.0 and 100.0 kg, inclusive, if male, and between 40.0 and 90.0 kg, inclusive, if female, body mass index between 18.0 and 30.0 kg/m2, inclusive.\n * Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination).\n * Normal vital signs, electrocardiogram, and laboratory parameters.\n * Female subject must use a double contraception method including a highly effective method of birth control, except if she has undergone sterilization at least 3 months earlier or is postmenopausal. The accepted double contraception methods include the use of 1 of the following contraceptive options: (1) intrauterine device; (2) condom or diaphragm or cervical/vault cap, in addition to spermicide. Menopause is defined as being amenorrheic for at least 2 years with plasma follicle stimulating hormone level >30 IU. Hormonal contraception is NOT acceptable in this study.\n * Male subject, whose partners are of childbearing potential (including lactating women), must accept to use, during sexual intercourse, a double contraception method according to the following algorithm: (condom) plus (spermicide or intra-uterine device or hormonal contraceptive) from the inclusion up to 4 months after the last dosing.\n * Male subject, whose partners are pregnant, must use, during sexual intercourse, a condom from the inclusion up to 4 months after the last dosing.\n * Male subject has agreed not to donate sperm from the inclusion up to 4 months after the last dosing.\n\n"," * Any medication (including St John's Wort) within 14 days before inclusion or within 5 times the elimination half-life or pharmacodynamic half-life of the medication, with the exception of hormonal contraception or menopausal hormone replacement therapy; any vaccination within the last 28 days and any biologics (antibody or its derivatives) given within 4 months before inclusion.\n * Positive result on any of the following tests: hepatitis B surface (HBs Ag) antigen, anti-hepatitis C virus (anti-HCV) antibodies, anti-human immunodeficiency virus 1 and 2 antibodies (anti-HIV1 and anti HIV2 Ab).\n * Positive result on urine drug screen or alcohol test.\n * Any contra-indications to hydrochlorothiazide, according to the applicable labeling.\n * Any history or presence of deep leg vein thrombosis or embolism or a recurrent or frequent appearance of deep leg vein thrombosis in first degree relatives (parents, siblings or children).\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial. ",{"$nulls":4},"Actual","2018-01-02","Actual","Anticipated","2018-03-01","Anticipated","2018-01-01","2017-12-20","2017-12-22","2018-01-29","No",null,"Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","18 Years","55 Years","All",null,"Yes","Yes\nQualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://www.clinicalstudydatarequest.com/",{"$nulls":3},"Yes","No",{"$nulls":17},"U1111-1186-2718","UTN","Assessment of PK parameter: AUCtau","Sotagliflozin without HCTZ: AUC to the end of the dosing period (AUCtau)|Sotagliflozin with HCTZ: AUCtau","Period 1, days 2 to 6|Period 2, days 6 to 10","Assessment of PK parameter: AUCtau|Assessment of PK parameter: Cmax|Assessment of PK parameter: tmax","HCTZ without sotagliflozin: AUCtau|HCTZ with sotagliflozin: AUCtau|Sotagliflozin-3-O-glucuronide without HCTZ: AUCtau|Sotagliflozin-3-O-glucuronide with HCTZ: AUCtau|HCTZ without sotagliflozin: Maximum plasma concentration (Cmax)|HCTZ with sotagliflozin: Cmax|Sotagliflozin-3-O-glucuronide without HCTZ: Cmax|Sotagliflozin-3-O-glucuronide with HCTZ: Cmax|HCTZ without sotagliflozin: Time to reach Cmax (tmax)|HCTZ with sotagliflozin: tmax|Sotagliflozin-3-O-glucuronide without HCTZ: tmax|Sotagliflozin-3-O-glucuronide with HCTZ: tmax|Sotagliflozin without HCTZ: Cmax|Sotagliflozin with HCTZ: Cmax|Sotagliflozin without HCTZ: tmax|Sotagliflozin with HCTZ: tmax","Period 2, days 4 to 5|Period 2, days 9 to 10|Period 1, days 2 to 6|Period 2, days 6 to 10","Contact-Us@sanofi.com","For site information, send an email with site number to",null,"Dallas, Texas, United States, 75247","Texas","United States","Investigational Site Number 8400001",{"$nulls":3},"Clinical Sciences & Operations","2018-01-29","2020-05-25T16:35:01.172","2020-05-26T17:10:42.972","NCT03387657"]
["5ecbf3b511702c1b1b91699a","NCT03387657","2018-04-13","Sanofi","SNY","Completed","A Drug to Drug Interaction Study of Sotagliflozin With Hydrochlorothiazide","Sotagliflozin|Hydrochlorothiazide","SGLT1 Inhibitor|SGLT2 Inhibitor|NCCT Inhibitor","Yes","['Sotagliflozin']","Yes","['SGLT1 Inhibitor']","Phase 1",1,16,"Actual","2018-01-03","2018-03-02","AUC","Area Under The Curve",{"$nulls":3},"Primary Objective:\n\nTo assess the effects of multiple-dose hydrochlorothiazide (HCTZ) on the steady-state pharmacokinetics (PK) of sotagliflozin.\n\nSecondary Objectives:\n\n * To assess the safety and tolerability of multiple-dose sotagliflozin with and without co-administration of multiple-dose HCTZ\n * To assess the effects of multiple-dose sotagliflozin on the steady-state PK of HCTZ\n * To assess the effects of multiple-dose HCTZ on the steady-state PK of sotagliflozin-3-O-glucuronide","Duration of the study for each subject will be between 33 to 77 days, including screening up to 28 days, 5 days of treatment Period 1, washout period of 7-21 days, 9 days of treatment Period 2, and follow-up period of 10-14 days after last dose of the Investigational Medicinal Product (IMP) in Period 2.","A Phase 1, Single-Center, Open-Label, Two-Period, Single-Sequence, Multiple Dosing Drug-Drug Interaction Study of Sotagliflozin and Hydrochlorothiazide in Healthy Male and Female Subjects","INT14905","Type 2 Diabetes Mellitus","Type 2 Diabetes","Metabolic Diseases","Nutritional Disorders","Experimental","Sotagliflozin + Hydrochlorothiazide (HCTZ)","Sotagliflozin to be administered alone in Period 1. HCTZ to be given in Period 2 for 4 days followed immediately by HCTZ and sotagliflozin for 5 days.","Drug","Sotagliflozin (SAR439954)|Hydrochlorothiazide",null,null,"Sotagliflozin + Hydrochlorothiazide (HCTZ)"," * Male or female subjects, between 18 and 55 years of age, inclusive.\n * Body weight between 50.0 and 100.0 kg, inclusive, if male, and between 40.0 and 90.0 kg, inclusive, if female, body mass index between 18.0 and 30.0 kg/m2, inclusive.\n * Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination).\n * Normal vital signs, electrocardiogram, and laboratory parameters.\n * Female subject must use a double contraception method including a highly effective method of birth control, except if she has undergone sterilization at least 3 months earlier or is postmenopausal. The accepted double contraception methods include the use of 1 of the following contraceptive options: (1) intrauterine device; (2) condom or diaphragm or cervical/vault cap, in addition to spermicide. Menopause is defined as being amenorrheic for at least 2 years with plasma follicle stimulating hormone level >30 IU. Hormonal contraception is NOT acceptable in this study.\n * Male subject, whose partners are of childbearing potential (including lactating women), must accept to use, during sexual intercourse, a double contraception method according to the following algorithm: (condom) plus (spermicide or intra-uterine device or hormonal contraceptive) from the inclusion up to 4 months after the last dosing.\n * Male subject, whose partners are pregnant, must use, during sexual intercourse, a condom from the inclusion up to 4 months after the last dosing.\n * Male subject has agreed not to donate sperm from the inclusion up to 4 months after the last dosing.\n\n"," * Any medication (including St John's Wort) within 14 days before inclusion or within 5 times the elimination half-life or pharmacodynamic half-life of the medication, with the exception of hormonal contraception or menopausal hormone replacement therapy; any vaccination within the last 28 days and any biologics (antibody or its derivatives) given within 4 months before inclusion.\n * Positive result on any of the following tests: hepatitis B surface (HBs Ag) antigen, anti-hepatitis C virus (anti-HCV) antibodies, anti-human immunodeficiency virus 1 and 2 antibodies (anti-HIV1 and anti HIV2 Ab).\n * Positive result on urine drug screen or alcohol test.\n * Any contra-indications to hydrochlorothiazide, according to the applicable labeling.\n * Any history or presence of deep leg vein thrombosis or embolism or a recurrent or frequent appearance of deep leg vein thrombosis in first degree relatives (parents, siblings or children).\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial. ",{"$nulls":4},"Actual","2018-01-02","Actual","Actual","2018-03-02","Actual","2018-04-01","2017-12-20","2017-12-22","2018-04-12","No",null,"Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","18 Years","55 Years","All",null,"Yes","Yes\nQualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://www.clinicalstudydatarequest.com/",{"$nulls":3},"Yes","No",{"$nulls":17},"U1111-1186-2718","UTN","Assessment of PK parameter: AUCtau","Sotagliflozin without HCTZ: AUC to the end of the dosing period (AUCtau)|Sotagliflozin with HCTZ: AUCtau","Period 1, days 2 to 6|Period 2, days 6 to 10","Assessment of PK parameter: AUCtau|Assessment of PK parameter: Cmax|Assessment of PK parameter: tmax","HCTZ without sotagliflozin: AUCtau|HCTZ with sotagliflozin: AUCtau|Sotagliflozin-3-O-glucuronide without HCTZ: AUCtau|Sotagliflozin-3-O-glucuronide with HCTZ: AUCtau|HCTZ without sotagliflozin: Maximum plasma concentration (Cmax)|HCTZ with sotagliflozin: Cmax|Sotagliflozin-3-O-glucuronide without HCTZ: Cmax|Sotagliflozin-3-O-glucuronide with HCTZ: Cmax|HCTZ without sotagliflozin: Time to reach Cmax (tmax)|HCTZ with sotagliflozin: tmax|Sotagliflozin-3-O-glucuronide without HCTZ: tmax|Sotagliflozin-3-O-glucuronide with HCTZ: tmax|Sotagliflozin without HCTZ: Cmax|Sotagliflozin with HCTZ: Cmax|Sotagliflozin without HCTZ: tmax|Sotagliflozin with HCTZ: tmax","Period 2, days 4 to 5|Period 2, days 9 to 10|Period 1, days 2 to 6|Period 2, days 6 to 10",{"$nulls":3},"Dallas, Texas, United States, 75247","Texas","United States","Investigational Site Number 8400001",{"$nulls":3},"Clinical Sciences & Operations","2018-04-12","2020-05-25T16:35:01.226","2020-05-26T17:10:42.972","NCT03387657"]
["5ecbf3b5fe30261b1a048187","NCT03387683","2018-01-02","AstraZeneca","AZN","Not yet recruiting","A Clinical Study to Investigate the Effects of Dapagliflozin on Heart Work, Heart Nutrient Uptake, and Heart Muscle Efficiency in Type 2 Diabetes Patients. (DAPACARD)","Dapagliflozin","SGLT2 Inhibitor","No",null,"No",null,"Phase 4",2,52,"Anticipated","2018-03-15","2019-01-21",{"$nulls":5},"This is a randomised, placebo-controlled, double-blind, parallel-group, international, multicentre, Phase IV study to investigate the effects of dapagliflozin on cardiac substrate uptake, myocardial efficiency and myocardial contractile work in T2D patients. Eligible subjects with T2D before randomisation and fulfilling all of the inclusion criteria and none of the exclusion criteria will be randomised in a 1:1 ratio to dapagliflozin 10 mg or placebo once daily and treated for six weeks. The study includes five visits.","The following will be assessed at Baseline and at the end of the treatment period;\n\n 1. MRI scanning in order to assess cardiac function and morphology. The MRI scanning will be made after fasting for at least 6 hours in the same time of day at all visits. The cardiac MRI examination will be performed in accordance with a pre-defined MRI protocol, with the total scan time at each visit estimated to 45 minutes. Images from all sites will be analyzed centrally at the core-lab using a dedicated software package and certified analysts.\n 2. CT-PET scanning will be made to assess myocardial function and metabolism, as well as fatty acid metabolism in brain, liver and kidney cortex. The CT-PET scanning will be made after a fast as well as abstinence from nicotine, alcohol and caffeine for at least 6 hours at the same time of day at all visits. * A cardiac 11C-Acetate PET/CT examination is performed (IV 400 MBq 11C-Acetate).\n     * A cardiac 18F-FTHA PET/CT examination is performed (IV 150 MBq 18F-FTHA). The subject is further examined by PET/CT over the liver, kidney cortex and brain (in this order) for uptake of 18F-FTHA. Arterialized venous samples are acquired throughout to assess P-NEFA and 18F-FTHA metabolism by metabolite analysis.","A Double-blind, Randomized, Parallel Group, Phase IV Study to Investigate the Effects of DAPAgliflozin on CARDiac Substrate Uptake, Myocardial Efficiency and Myocardial Contractile Work in Type 2 Diabetes Patients","D1690C00063","Diabetes Mellitus Type 2","Type 2 Diabetes","Metabolic Diseases","Nutritional Disorders","Placebo Comparator|Experimental","placebo|dapagliflozin 10mg","placebo tablets once daily|dapagliflozin 10mg tablets once daily","Drug","placebo|dapagliflozin","placebo to match dapagliflozin|dapagliflozin 10mg","Forxiga 10mg","placebo|dapagliflozin 10mg","\n\n * Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.\n * Provision of signed and dated, written informed consent form prior to any mandatory study specific procedures, sampling, and analyses.\n * Females or males â‰¥40 years up to 75 years of age.\n * Individuals with type 2 diabetes diagnosed for at least 6 months based on the American Diabetes Association standards (ADA, 2017) and on stable dose of metformin for at least 6 weeks prior to screening and HbA1c at screening visit of â‰¥42 mmol/mol (6.0%) and â‰¤75 mmol/mol (9.0%) measured at local hospital laboratory.\n * No significant signs or symptoms of coronary artery disease or, if known coronary artery disease, currently free of symptoms and a) all major epicardial vessels with <50% stenosis within 12 months prior to screening, or b) if revascularized with all major epicardial vessels with <50% remaining stenosis after stenting or bypass surgery procedure determined between 3 and 12 months prior to screening.\n * Normal left ventricular ejection fraction (â‰¥50%) assessed within 1 year prior to informed consent, and if applicable, after most recent acute episode of coronary artery syndrome, or at screening visit.\n * Body mass index (BMI) â‰¥ 25 kg/m2.\n\n","\n\n * Blood pressure at screening that would require a change in blood pressure treatment over the study period or any of the following: systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg.\n * History of stroke or other clinically significant cerebrovascular disease.\n * Any of the following cardiovascular diseases known within 3 months prior to signing the consent at enrolment: 1. Atrial fibrillation, or other unstable or severe arrhythmia affecting heart function\n    2. Unstable heart failure or any heart failure with NYHA class III and IV\n    3. Significant valvular disease\n    4. Significant peripheral artery disease\n   \n   \n * Planned cardiac surgery or angioplasty within 3 months from enrolment.\n * Clinical diagnosis of type 1 diabetes, maturity onset diabetes of the young (MODY), secondary diabetes or diabetes insipidus.\n * Verified body weight variability of >3 kg during the 3 proceeding months before screening.\n * Active malignancy requiring treatment at the time of visit 1 (with the exception of successfully treated basal cell or treated squamous cell carcinoma).\n * Patients with severe hepatic impairment (Child-Pugh class C).\n * Unstable or rapidly progressing renal disease.\n * Clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.\n * Ongoing treatment with other antidiabetic drugs than metformin.\n * Ongoing treatment with loop diuretics.\n * Ongoing weight-loss diet (hypocaloric diet) or use of weight loss agents.\n * Contraindications to dapagliflozin therapy.\n * Ongoing treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent or any other uncontrolled endocrine disorder except for T2D.\n * Previous enrolment in the present study or participation in another clinical study with an investigational product during the last 1 month prior to screening.\n * Estimated Glomerular Filtration Rate (eGFR) <45 mL/min/1.73 m2.\n * Alcohol or drug abuse within the 3 months prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to study procedures or study treatment intake.\n * Any condition when MRI and CT-PET is contraindicated such as, but not limited to, having a metallic implant (such as pacemaker or cochlear implant), permanent make up, claustrophobia or BMI â‰¥40 kg/m2).\n * Involvement in the planning and/or conduct of the study.\n * Plasma donation within one month of screening or any blood donation/blood loss >450 mL during the 3 months prior to screening.\n * Women who has a positive pregnancy test at enrolment or randomization, or are breastfeeding.",{"$nulls":4},"Actual","2018-01-02","Actual","Anticipated","2019-01-21","Anticipated","2017-12-01","2017-12-18","2017-12-22","2017-12-22","No",null,"Interventional","Treatment","Parallel Assignment","Triple (Participant, Care Provider, Investigator)","Randomized","40 Years","75 Years","All",null,"No",{"$nulls":4},"No","No",{"$nulls":17},"2017-003820-58","EudraCT Number","Global longitudinal strain of the left ventricle (GLSLV)","Change from baseline in global longitudinal strain of the left ventricle (GLSLV) in %","Baseline and 6 weeks","Myocardial efficiency|Other Pre-specified Outcome Measures:|Myocardial perfusion|Myocardial fatty acid uptake|Left atrial volumes|Left atrial ejection fraction|Left atrial transmitral flow velocity|Fatty acid uptake in the liver|Fatty acid uptake in the kidney cortex|Fatty acid uptake in the brain","Change from baseline in myocardial efficiency (%)|Other Pre-specified Outcome Measures:|Changes from baseline in myocardial perfusion measured by|Changes from baseline in myocardial fatty acid uptake measured by|Changes from baseline in Left atrial min volume and max volume,|Left atrial ejection fraction (%)|Left atrial transmitral flow velocity indices (E/A, E, A and DT)|Changes from baseline in fatty acid uptake in liver by|Changes from baseline in fatty acid uptake in kidney cortex by|Changes from baseline in fatty acid uptake in brain measured by","Baseline and 6 weeks|11C-Acetate|18F-FTHA","information.center@astrazeneca.com","AstraZeneca Clinical Study Information Center","1-877-240-9479",{"$nulls":8},"2017-12-22","2020-05-25T16:35:01.314","2020-05-26T17:10:42.972","NCT03387683"]
["5ecbf3b5307e3d1b1f8d9c17","NCT03387683","2018-03-13","AstraZeneca","AZN","Recruiting","A Clinical Study to Investigate the Effects of Dapagliflozin on Heart Work, Heart Nutrient Uptake, and Heart Muscle Efficiency in Type 2 Diabetes Patients. (DAPACARD)","Dapagliflozin","SGLT2 Inhibitor","No",null,"No",null,"Phase 4",2,52,"Anticipated","2018-02-28","2019-01-24",{"$nulls":5},"This is a randomised, placebo-controlled, double-blind, parallel-group, international, multicentre, Phase IV study to investigate the effects of dapagliflozin on cardiac substrate uptake, myocardial efficiency and myocardial contractile work in T2D patients. Eligible subjects with T2D before randomisation and fulfilling all of the inclusion criteria and none of the exclusion criteria will be randomised in a 1:1 ratio to dapagliflozin 10 mg or placebo once daily and treated for six weeks. The study includes five visits.","The following will be assessed at Baseline and at the end of the treatment period;\n\n 1. MRI scanning in order to assess cardiac function and morphology. The MRI scanning will be made after fasting for at least 6 hours in the same time of day at all visits. The cardiac MRI examination will be performed in accordance with a pre-defined MRI protocol, with the total scan time at each visit estimated to 45 minutes. Images from all sites will be analyzed centrally at the core-lab using a dedicated software package and certified analysts.\n 2. CT-PET scanning will be made to assess myocardial function and metabolism, as well as fatty acid metabolism in brain, liver and kidney cortex. The CT-PET scanning will be made after a fast as well as abstinence from nicotine, alcohol and caffeine for at least 6 hours at the same time of day at all visits. * A cardiac 11C-Acetate PET/CT examination is performed (IV 400 MBq 11C-Acetate).\n     * A cardiac 18F-FTHA PET/CT examination is performed (IV 150 MBq 18F-FTHA). The subject is further examined by PET/CT over the liver, kidney cortex and brain (in this order) for uptake of 18F-FTHA. Arterialized venous samples are acquired throughout to assess P-NEFA and 18F-FTHA metabolism by metabolite analysis.","A Double-blind, Randomized, Parallel Group, Phase IV Study to Investigate the Effects of DAPAgliflozin on CARDiac Substrate Uptake, Myocardial Efficiency and Myocardial Contractile Work in Type 2 Diabetes Patients","D1690C00063","Diabetes Mellitus Type 2","Type 2 Diabetes","Metabolic Diseases","Nutritional Disorders","Placebo Comparator|Experimental","placebo|dapagliflozin 10mg","placebo tablets once daily|dapagliflozin 10mg tablets once daily","Drug","placebo|dapagliflozin","placebo to match dapagliflozin|dapagliflozin 10mg","Forxiga 10mg","placebo|dapagliflozin 10mg","\n\n * Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.\n * Provision of signed and dated, written informed consent form prior to any mandatory study specific procedures, sampling, and analyses.\n * Females or males â‰¥40 years up to 75 years of age.\n * Individuals with type 2 diabetes diagnosed for at least 6 months based on the American Diabetes Association standards (ADA, 2017) and on stable dose of metformin for at least 6 weeks prior to screening and HbA1c at screening visit of â‰¥42 mmol/mol (6.0%) and â‰¤75 mmol/mol (9.0%) measured at local hospital laboratory.\n * No significant signs or symptoms of coronary artery disease or, if known coronary artery disease, currently free of symptoms and a) all major epicardial vessels with <50% stenosis within 12 months prior to screening, or b) if revascularized with all major epicardial vessels with <50% remaining stenosis after stenting or bypass surgery procedure determined between 3 and 12 months prior to screening.\n * Normal left ventricular ejection fraction (â‰¥50%) assessed within 1 year prior to informed consent, and if applicable, after most recent acute episode of coronary artery syndrome, or at screening visit.\n * Body mass index (BMI) â‰¥ 25 kg/m2.\n\n","\n\n * Blood pressure at screening that would require a change in blood pressure treatment over the study period or any of the following: systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg.\n * History of stroke or other clinically significant cerebrovascular disease.\n * Any of the following cardiovascular diseases known within 3 months prior to signing the consent at enrolment: 1. Atrial fibrillation, or other unstable or severe arrhythmia affecting heart function\n    2. Unstable heart failure or any heart failure with NYHA class III and IV\n    3. Significant valvular disease\n    4. Significant peripheral artery disease\n   \n   \n * Planned cardiac surgery or angioplasty within 3 months from enrolment.\n * Clinical diagnosis of type 1 diabetes, maturity onset diabetes of the young (MODY), secondary diabetes or diabetes insipidus.\n * Verified body weight variability of >3 kg during the 3 proceeding months before screening.\n * Active malignancy requiring treatment at the time of visit 1 (with the exception of successfully treated basal cell or treated squamous cell carcinoma).\n * Patients with severe hepatic impairment (Child-Pugh class C).\n * Unstable or rapidly progressing renal disease.\n * Clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.\n * Ongoing treatment with other antidiabetic drugs than metformin.\n * Ongoing treatment with loop diuretics.\n * Ongoing weight-loss diet (hypocaloric diet) or use of weight loss agents.\n * Contraindications to dapagliflozin therapy.\n * Ongoing treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent or any other uncontrolled endocrine disorder except for T2D.\n * Previous enrolment in the present study or participation in another clinical study with an investigational product during the last 1 month prior to screening.\n * Estimated Glomerular Filtration Rate (eGFR) <45 mL/min/1.73 m2.\n * Alcohol or drug abuse within the 3 months prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to study procedures or study treatment intake.\n * Any condition when MRI and CT-PET is contraindicated such as, but not limited to, having a metallic implant (such as pacemaker or cochlear implant), permanent make up, claustrophobia or BMI â‰¥40 kg/m2).\n * Involvement in the planning and/or conduct of the study.\n * Plasma donation within one month of screening or any blood donation/blood loss >450 mL during the 3 months prior to screening.\n * Women who has a positive pregnancy test at enrolment or randomization, or are breastfeeding.",{"$nulls":4},"Actual","2018-01-02","Actual","Anticipated","2019-01-24","Anticipated","2018-03-01","2017-12-18","2017-12-22","2018-03-12","No",null,"Interventional","Treatment","Parallel Assignment","Triple (Participant, Care Provider, Investigator)","Randomized","40 Years","75 Years","All",null,"No",{"$nulls":4},"No","No",{"$nulls":17},"2017-003820-58","EudraCT Number","Global longitudinal strain of the left ventricle (GLSLV)","Change from baseline in global longitudinal strain of the left ventricle (GLSLV) in %","Baseline and 6 weeks","Myocardial efficiency|Other Pre-specified Outcome Measures:|Myocardial perfusion|Myocardial fatty acid uptake|Left atrial volumes|Left atrial ejection fraction|Left atrial transmitral flow velocity|Fatty acid uptake in the liver|Fatty acid uptake in the kidney cortex|Fatty acid uptake in the brain","Change from baseline in myocardial efficiency (%)|Other Pre-specified Outcome Measures:|Changes from baseline in myocardial perfusion measured by|Changes from baseline in myocardial fatty acid uptake measured by|Changes from baseline in Left atrial min volume and max volume,|Left atrial ejection fraction (%)|Left atrial transmitral flow velocity indices (E/A, E, A and DT)|Changes from baseline in fatty acid uptake in liver by|Changes from baseline in fatty acid uptake in kidney cortex by|Changes from baseline in fatty acid uptake in brain measured by","Baseline and 6 weeks|11C-Acetate|18F-FTHA","information.center@astrazeneca.com","AstraZeneca Clinical Study Information Center","1-877-240-9479","Turku, Finland, 20520|Uppsala, Sweden, Se-751 85",null,"Finland|Sweden","Research Site",{"$nulls":4},"2018-03-12","2020-05-25T16:35:01.466","2020-05-26T17:10:42.972","NCT03387683"]
["5ecbf3b511702c1b1b91699b","NCT03387683","2018-04-12","AstraZeneca","AZN","Recruiting","A Clinical Study to Investigate the Effects of Dapagliflozin on Heart Work, Heart Nutrient Uptake, and Heart Muscle Efficiency in Type 2 Diabetes Patients. (DAPACARD)","Dapagliflozin","SGLT2 Inhibitor","No",null,"No",null,"Phase 4",2,52,"Anticipated","2018-02-28","2019-01-24",{"$nulls":5},"This is a randomised, placebo-controlled, double-blind, parallel-group, international, multicentre, Phase IV study to investigate the effects of dapagliflozin on cardiac substrate uptake, myocardial efficiency and myocardial contractile work in T2D patients. Eligible subjects with T2D before randomisation and fulfilling all of the inclusion criteria and none of the exclusion criteria will be randomised in a 1:1 ratio to dapagliflozin 10 mg or placebo once daily and treated for six weeks. The study includes five visits.","The following will be assessed at Baseline and at the end of the treatment period;\n\n 1. MRI scanning in order to assess cardiac function and morphology. The MRI scanning will be made after fasting for at least 6 hours in the same time of day at all visits. The cardiac MRI examination will be performed in accordance with a pre-defined MRI protocol, with the total scan time at each visit estimated to 45 minutes. Images from all sites will be analyzed centrally at the core-lab using a dedicated software package and certified analysts.\n 2. CT-PET scanning will be made to assess myocardial function and metabolism, as well as fatty acid metabolism in brain, liver and kidney cortex. The CT-PET scanning will be made after a fast as well as abstinence from nicotine, alcohol and caffeine for at least 6 hours at the same time of day at all visits. * A cardiac 11C-Acetate PET/CT examination is performed (IV 400 MBq 11C-Acetate).\n     * A cardiac 18F-FTHA PET/CT examination is performed (IV 150 MBq 18F-FTHA). The subject is further examined by PET/CT over the liver, kidney cortex and brain (in this order) for uptake of 18F-FTHA. Arterialized venous samples are acquired throughout to assess P-NEFA and 18F-FTHA metabolism by metabolite analysis.","A Double-blind, Randomized, Parallel Group, Phase IV Study to Investigate the Effects of DAPAgliflozin on CARDiac Substrate Uptake, Myocardial Efficiency and Myocardial Contractile Work in Type 2 Diabetes Patients","D1690C00063","Diabetes Mellitus Type 2","Type 2 Diabetes","Metabolic Diseases","Nutritional Disorders","Placebo Comparator|Experimental","placebo|dapagliflozin 10mg","placebo tablets once daily|dapagliflozin 10mg tablets once daily","Drug","placebo|dapagliflozin","placebo to match dapagliflozin|dapagliflozin 10mg","Forxiga 10mg","placebo|dapagliflozin 10mg","\n\n * Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.\n * Provision of signed and dated, written informed consent form prior to any mandatory study specific procedures, sampling, and analyses.\n * Females or males â‰¥40 years up to 75 years of age.\n * Individuals with type 2 diabetes diagnosed for at least 6 months based on the American Diabetes Association standards (ADA, 2017) and on stable dose of metformin for at least 6 weeks prior to screening and HbA1c at screening visit of â‰¥42 mmol/mol (6.0%) and â‰¤75 mmol/mol (9.0%) measured at local hospital laboratory.\n * No significant signs or symptoms of coronary artery disease or, if known coronary artery disease, currently free of symptoms and a) all major epicardial vessels with <50% stenosis within 12 months prior to screening, or b) if revascularized with all major epicardial vessels with <50% remaining stenosis after stenting or bypass surgery procedure determined between 3 and 12 months prior to screening.\n * Normal left ventricular ejection fraction (â‰¥50%) assessed within 1 year prior to informed consent, and if applicable, after most recent acute episode of coronary artery syndrome, or at screening visit.\n * Body mass index (BMI) â‰¥ 25 kg/m2.\n\n","\n\n * Blood pressure at screening that would require a change in blood pressure treatment over the study period or any of the following: systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg.\n * History of stroke or other clinically significant cerebrovascular disease.\n * Any of the following cardiovascular diseases known within 3 months prior to signing the consent at enrolment: 1. Atrial fibrillation, or other unstable or severe arrhythmia affecting heart function\n    2. Unstable heart failure or any heart failure with NYHA class III and IV\n    3. Significant valvular disease\n    4. Significant peripheral artery disease\n   \n   \n * Planned cardiac surgery or angioplasty within 3 months from enrolment.\n * Clinical diagnosis of type 1 diabetes, maturity onset diabetes of the young (MODY), secondary diabetes or diabetes insipidus.\n * Verified body weight variability of >3 kg during the 3 proceeding months before screening.\n * Active malignancy requiring treatment at the time of visit 1 (with the exception of successfully treated basal cell or treated squamous cell carcinoma).\n * Patients with severe hepatic impairment (Child-Pugh class C).\n * Unstable or rapidly progressing renal disease.\n * Clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.\n * Ongoing treatment with other antidiabetic drugs than metformin.\n * Ongoing treatment with loop diuretics.\n * Ongoing weight-loss diet (hypocaloric diet) or use of weight loss agents.\n * Contraindications to dapagliflozin therapy.\n * Ongoing treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent or any other uncontrolled endocrine disorder except for T2D.\n * Previous enrolment in the present study or participation in another clinical study with an investigational product during the last 1 month prior to screening.\n * Estimated Glomerular Filtration Rate (eGFR) <45 mL/min/1.73 m2.\n * Alcohol or drug abuse within the 3 months prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to study procedures or study treatment intake.\n * Any condition when MRI and CT-PET is contraindicated such as, but not limited to, having a metallic implant (such as pacemaker or cochlear implant), permanent make up, claustrophobia or BMI â‰¥40 kg/m2).\n * Involvement in the planning and/or conduct of the study.\n * Plasma donation within one month of screening or any blood donation/blood loss >450 mL during the 3 months prior to screening.\n * Women who has a positive pregnancy test at enrolment or randomization, or are breastfeeding.",{"$nulls":4},"Actual","2018-01-02","Actual","Anticipated","2019-01-24","Anticipated","2018-04-01","2017-12-18","2017-12-22","2018-04-11","No",null,"Interventional","Treatment","Parallel Assignment","Triple (Participant, Care Provider, Investigator)","Randomized","40 Years","75 Years","All",null,"No",{"$nulls":4},"No","No",{"$nulls":17},"2017-003820-58","EudraCT Number","Global longitudinal strain of the left ventricle (GLSLV)","Change from baseline in global longitudinal strain of the left ventricle (GLSLV) in %","Baseline and 6 weeks","Myocardial efficiency|Other Pre-specified Outcome Measures:|Myocardial perfusion|Myocardial fatty acid uptake|Left atrial volumes|Left atrial ejection fraction|Left atrial transmitral flow velocity|Fatty acid uptake in the liver|Fatty acid uptake in the kidney cortex|Fatty acid uptake in the brain","Change from baseline in myocardial efficiency (%)|Other Pre-specified Outcome Measures:|Changes from baseline in myocardial perfusion measured by|Changes from baseline in myocardial fatty acid uptake measured by|Changes from baseline in Left atrial min volume and max volume,|Left atrial ejection fraction (%)|Left atrial transmitral flow velocity indices (E/A, E, A and DT)|Changes from baseline in fatty acid uptake in liver by|Changes from baseline in fatty acid uptake in kidney cortex by|Changes from baseline in fatty acid uptake in brain measured by","Baseline and 6 weeks|11C-Acetate|18F-FTHA","information.center@astrazeneca.com","AstraZeneca Clinical Study Information Center","1-877-240-9479","Turku, Finland, 20520|Uppsala, Sweden, Se-751 85",null,"Finland|Sweden","Research Site",{"$nulls":4},"2018-04-11","2020-05-25T16:35:01.509","2020-05-26T17:10:42.972","NCT03387683"]
["5ecbf3b5e2561b1b11905c83","NCT03387683","2018-05-14","AstraZeneca","AZN","Recruiting","A Clinical Study to Investigate the Effects of Dapagliflozin on Heart Work, Heart Nutrient Uptake, and Heart Muscle Efficiency in Type 2 Diabetes Patients. (DAPACARD)","Dapagliflozin","SGLT2 Inhibitor","No",null,"No",null,"Phase 4",2,52,"Anticipated","2018-02-28","2019-01-24",{"$nulls":5},"This is a randomised, placebo-controlled, double-blind, parallel-group, international, multicentre, Phase IV study to investigate the effects of dapagliflozin on cardiac substrate uptake, myocardial efficiency and myocardial contractile work in T2D patients. Eligible subjects with T2D before randomisation and fulfilling all of the inclusion criteria and none of the exclusion criteria will be randomised in a 1:1 ratio to dapagliflozin 10 mg or placebo once daily and treated for six weeks. The study includes five visits.","The following will be assessed at Baseline and at the end of the treatment period;\n\n 1. MRI scanning in order to assess cardiac function and morphology. The MRI scanning will be made after fasting for at least 6 hours in the same time of day at all visits. The cardiac MRI examination will be performed in accordance with a pre-defined MRI protocol, with the total scan time at each visit estimated to 45 minutes. Images from all sites will be analyzed centrally at the core-lab using a dedicated software package and certified analysts.\n 2. CT-PET scanning will be made to assess myocardial function and metabolism, as well as fatty acid metabolism in brain, liver and kidney cortex. The CT-PET scanning will be made after a fast as well as abstinence from nicotine, alcohol and caffeine for at least 6 hours at the same time of day at all visits. * A cardiac 11C-Acetate PET/CT examination is performed (IV 400 MBq 11C-Acetate).\n     * A cardiac 18F-FTHA PET/CT examination is performed (IV 150 MBq 18F-FTHA). The subject is further examined by PET/CT over the liver, kidney cortex and brain (in this order) for uptake of 18F-FTHA. Arterialized venous samples are acquired throughout to assess P-NEFA and 18F-FTHA metabolism by metabolite analysis.","A Double-blind, Randomized, Parallel Group, Phase IV Study to Investigate the Effects of DAPAgliflozin on CARDiac Substrate Uptake, Myocardial Efficiency and Myocardial Contractile Work in Type 2 Diabetes Patients","D1690C00063","Diabetes Mellitus Type 2","Type 2 Diabetes","Metabolic Diseases","Nutritional Disorders","Placebo Comparator|Experimental","placebo|dapagliflozin 10mg","placebo tablets once daily|dapagliflozin 10mg tablets once daily","Drug","placebo|dapagliflozin","placebo to match dapagliflozin|dapagliflozin 10mg","Forxiga 10mg","placebo|dapagliflozin 10mg","\n\n * Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.\n * Provision of signed and dated, written informed consent form prior to any mandatory study specific procedures, sampling, and analyses.\n * Females or males â‰¥40 years up to 75 years of age.\n * Individuals with type 2 diabetes diagnosed for at least 6 months based on the American Diabetes Association standards (ADA, 2017) and on stable dose of metformin for at least 6 weeks prior to screening and HbA1c at screening visit of â‰¥42 mmol/mol (6.0%) and â‰¤75 mmol/mol (9.0%) measured at local hospital laboratory.\n * No significant signs or symptoms of coronary artery disease or, if known coronary artery disease, currently free of symptoms and a) all major epicardial vessels with <50% stenosis within 12 months prior to screening, or b) if revascularized with all major epicardial vessels with <50% remaining stenosis after stenting or bypass surgery procedure determined between 3 and 12 months prior to screening.\n * Normal left ventricular ejection fraction (â‰¥50%) assessed within 1 year prior to informed consent, and if applicable, after most recent acute episode of coronary artery syndrome, or at screening visit.\n * Body mass index (BMI) â‰¥ 25 kg/m2.\n\n","\n\n * Blood pressure at screening that would require a change in blood pressure treatment over the study period or any of the following: systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg.\n * History of stroke or other clinically significant cerebrovascular disease.\n * Any of the following cardiovascular diseases known within 3 months prior to signing the consent at enrolment: 1. Atrial fibrillation, or other unstable or severe arrhythmia affecting heart function\n    2. Unstable heart failure or any heart failure with NYHA class III and IV\n    3. Significant valvular disease\n    4. Significant peripheral artery disease\n   \n   \n * Planned cardiac surgery or angioplasty within 3 months from enrolment.\n * Clinical diagnosis of type 1 diabetes, maturity onset diabetes of the young (MODY), secondary diabetes or diabetes insipidus.\n * Verified body weight variability of >3 kg during the 3 proceeding months before screening.\n * Active malignancy requiring treatment at the time of visit 1 (with the exception of successfully treated basal cell or treated squamous cell carcinoma).\n * Patients with severe hepatic impairment (Child-Pugh class C).\n * Unstable or rapidly progressing renal disease.\n * Clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.\n * Ongoing treatment with other antidiabetic drugs than metformin.\n * Ongoing treatment with loop diuretics.\n * Ongoing weight-loss diet (hypocaloric diet) or use of weight loss agents.\n * Contraindications to dapagliflozin therapy.\n * Ongoing treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent or any other uncontrolled endocrine disorder except for T2D.\n * Previous enrolment in the present study or participation in another clinical study with an investigational product during the last 1 month prior to screening.\n * Estimated Glomerular Filtration Rate (eGFR) <45 mL/min/1.73 m2.\n * Alcohol or drug abuse within the 3 months prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to study procedures or study treatment intake.\n * Any condition when MRI and CT-PET is contraindicated such as, but not limited to, having a metallic implant (such as pacemaker or cochlear implant), permanent make up, claustrophobia or BMI â‰¥40 kg/m2).\n * Involvement in the planning and/or conduct of the study.\n * Plasma donation within one month of screening or any blood donation/blood loss >450 mL during the 3 months prior to screening.\n * Women who has a positive pregnancy test at enrolment or randomization, or are breastfeeding.",{"$nulls":4},"Actual","2018-01-02","Actual","Anticipated","2019-01-24","Anticipated","2018-05-01","2017-12-18","2017-12-22","2018-05-11","No",null,"Interventional","Treatment","Parallel Assignment","Triple (Participant, Care Provider, Investigator)","Randomized","40 Years","75 Years","All",null,"No",{"$nulls":4},"No","No",{"$nulls":17},"2017-003820-58","EudraCT Number","Global longitudinal strain of the left ventricle (GLSLV)","Change from baseline in global longitudinal strain of the left ventricle (GLSLV) in %","Baseline and 6 weeks","Myocardial efficiency|Other Pre-specified Outcome Measures:|Myocardial perfusion|Myocardial fatty acid uptake|Left atrial volumes|Left atrial ejection fraction|Left atrial transmitral flow velocity|Fatty acid uptake in the liver|Fatty acid uptake in the kidney cortex|Fatty acid uptake in the brain","Change from baseline in myocardial efficiency (%)|Other Pre-specified Outcome Measures:|Changes from baseline in myocardial perfusion measured by|Changes from baseline in myocardial fatty acid uptake measured by|Changes from baseline in Left atrial min volume and max volume,|Left atrial ejection fraction (%)|Left atrial transmitral flow velocity indices (E/A, E, A and DT)|Changes from baseline in fatty acid uptake in liver by|Changes from baseline in fatty acid uptake in kidney cortex by|Changes from baseline in fatty acid uptake in brain measured by","Baseline and 6 weeks|11C-Acetate|18F-FTHA","information.center@astrazeneca.com","AstraZeneca Clinical Study Information Center","1-877-240-9479","Turku, Finland, 20520|Uppsala, Sweden, Se-751 85",null,"Finland|Sweden","Research Site",{"$nulls":4},"2018-05-11","2020-05-25T16:35:01.575","2020-05-26T17:10:42.972","NCT03387683"]
["5ecbf3b5feab101b155307b8","NCT03387683","2018-06-12","AstraZeneca","AZN","Recruiting","A Clinical Study to Investigate the Effects of Dapagliflozin on Heart Work, Heart Nutrient Uptake, and Heart Muscle Efficiency in Type 2 Diabetes Patients. (DAPACARD)","Dapagliflozin","SGLT2 Inhibitor","No",null,"No",null,"Phase 4",2,52,"Anticipated","2018-02-28","2019-04-01",{"$nulls":5},"This is a randomised, placebo-controlled, double-blind, parallel-group, international, multicentre, Phase IV study to investigate the effects of dapagliflozin on cardiac substrate uptake, myocardial efficiency and myocardial contractile work in T2D patients. Eligible subjects with T2D before randomisation and fulfilling all of the inclusion criteria and none of the exclusion criteria will be randomised in a 1:1 ratio to dapagliflozin 10 mg or placebo once daily and treated for six weeks. The study includes five visits.","The following will be assessed at Baseline and at the end of the treatment period;\n\n 1. MRI scanning in order to assess cardiac function and morphology. The MRI scanning will be made after fasting for at least 6 hours in the same time of day at all visits. The cardiac MRI examination will be performed in accordance with a pre-defined MRI protocol, with the total scan time at each visit estimated to 45 minutes. Images from all sites will be analyzed centrally at the core-lab using a dedicated software package and certified analysts.\n 2. CT-PET scanning will be made to assess myocardial function and metabolism, as well as fatty acid metabolism in brain, liver and kidney cortex. The CT-PET scanning will be made after a fast as well as abstinence from nicotine, alcohol and caffeine for at least 6 hours at the same time of day at all visits. * A cardiac 11C-Acetate PET/CT examination is performed (IV 400 MBq 11C-Acetate).\n     * A cardiac 18F-FTHA PET/CT examination is performed (IV 150 MBq 18F-FTHA). The subject is further examined by PET/CT over the liver, kidney cortex and brain (in this order) for uptake of 18F-FTHA. Arterialized venous samples are acquired throughout to assess P-NEFA and 18F-FTHA metabolism by metabolite analysis.","A Double-blind, Randomized, Parallel Group, Phase IV Study to Investigate the Effects of DAPAgliflozin on CARDiac Substrate Uptake, Myocardial Efficiency and Myocardial Contractile Work in Type 2 Diabetes Patients","D1690C00063","Diabetes Mellitus Type 2","Type 2 Diabetes","Metabolic Diseases","Nutritional Disorders","Placebo Comparator|Experimental","placebo|dapagliflozin 10mg","placebo tablets once daily|dapagliflozin 10mg tablets once daily","Drug","placebo|dapagliflozin","placebo to match dapagliflozin|dapagliflozin 10mg","Forxiga 10mg","placebo|dapagliflozin 10mg","\n\n * Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.\n * Provision of signed and dated, written informed consent form prior to any mandatory study specific procedures, sampling, and analyses.\n * Females or males â‰¥40 years up to 75 years of age.\n * Individuals with type 2 diabetes diagnosed for at least 6 months based on the American Diabetes Association standards (ADA, 2017) and on stable dose of metformin for at least 6 weeks prior to screening and HbA1c at screening visit of â‰¥42 mmol/mol (6.0%) and â‰¤75 mmol/mol (9.0%) measured at local hospital laboratory.\n * No significant signs or symptoms of coronary artery disease or, if known coronary artery disease, currently free of symptoms and a) all major epicardial vessels with <50% stenosis within 12 months prior to screening, or b) if revascularized with all major epicardial vessels with <50% remaining stenosis after stenting or bypass surgery procedure determined between 3 and 12 months prior to screening.\n * Normal left ventricular ejection fraction (â‰¥50%) assessed within 1 year prior to informed consent, and if applicable, after most recent acute episode of coronary artery syndrome, or at screening visit.\n * Body mass index (BMI) â‰¥ 25 kg/m2.\n\n","\n\n * Blood pressure at screening that would require a change in blood pressure treatment over the study period or any of the following: systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg.\n * History of stroke or other clinically significant cerebrovascular disease.\n * Any of the following cardiovascular diseases known within 3 months prior to signing the consent at enrolment: 1. Atrial fibrillation, or other unstable or severe arrhythmia affecting heart function\n    2. Unstable heart failure or any heart failure with NYHA class III and IV\n    3. Significant valvular disease\n    4. Significant peripheral artery disease\n   \n   \n * Planned cardiac surgery or angioplasty within 3 months from enrolment.\n * Clinical diagnosis of type 1 diabetes, maturity onset diabetes of the young (MODY), secondary diabetes or diabetes insipidus.\n * Verified body weight variability of >3 kg during the 3 proceeding months before screening.\n * Active malignancy requiring treatment at the time of visit 1 (with the exception of successfully treated basal cell or treated squamous cell carcinoma).\n * Patients with severe hepatic impairment (Child-Pugh class C).\n * Unstable or rapidly progressing renal disease.\n * Clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.\n * Ongoing treatment with other antidiabetic drugs than metformin.\n * Ongoing treatment with loop diuretics.\n * Ongoing weight-loss diet (hypocaloric diet) or use of weight loss agents.\n * Contraindications to dapagliflozin therapy.\n * Ongoing treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent or any other uncontrolled endocrine disorder except for T2D.\n * Previous enrolment in the present study or participation in another clinical study with an investigational product during the last 1 month prior to screening.\n * Estimated Glomerular Filtration Rate (eGFR) <45 mL/min/1.73 m2.\n * Alcohol or drug abuse within the 3 months prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to study procedures or study treatment intake.\n * Any condition when MRI and CT-PET is contraindicated such as, but not limited to, having a metallic implant (such as pacemaker or cochlear implant), permanent make up, claustrophobia or BMI â‰¥40 kg/m2).\n * Involvement in the planning and/or conduct of the study.\n * Plasma donation within one month of screening or any blood donation/blood loss >450 mL during the 3 months prior to screening.\n * Women who has a positive pregnancy test at enrolment or randomization, or are breastfeeding.",{"$nulls":4},"Actual","2018-01-02","Actual","Anticipated","2019-04-01","Anticipated","2018-06-01","2017-12-18","2017-12-22","2018-06-11","No",null,"Interventional","Treatment","Parallel Assignment","Triple (Participant, Care Provider, Investigator)","Randomized","40 Years","75 Years","All",null,"No",{"$nulls":4},"No","No",{"$nulls":17},"2017-003820-58","EudraCT Number","Global longitudinal strain of the left ventricle (GLSLV)","Change from baseline in global longitudinal strain of the left ventricle (GLSLV) in %","Baseline and 6 weeks","Myocardial efficiency|Other Pre-specified Outcome Measures:|Myocardial perfusion|Myocardial fatty acid uptake|Left atrial volumes|Left atrial ejection fraction|Left atrial transmitral flow velocity|Fatty acid uptake in the liver|Fatty acid uptake in the kidney cortex|Fatty acid uptake in the brain","Change from baseline in myocardial efficiency (%)|Other Pre-specified Outcome Measures:|Changes from baseline in myocardial perfusion measured by|Changes from baseline in myocardial fatty acid uptake measured by|Changes from baseline in Left atrial min volume and max volume,|Left atrial ejection fraction (%)|Left atrial transmitral flow velocity indices (E/A, E, A and DT)|Changes from baseline in fatty acid uptake in liver by|Changes from baseline in fatty acid uptake in kidney cortex by|Changes from baseline in fatty acid uptake in brain measured by","Baseline and 6 weeks|11C-Acetate|18F-FTHA","information.center@astrazeneca.com","AstraZeneca Clinical Study Information Center","1-877-240-9479","Turku, Finland, 20520|Uppsala, Sweden, Se-751 85",null,"Finland|Sweden","Research Site",{"$nulls":4},"2018-06-11","2020-05-25T16:35:01.682","2020-05-26T17:10:42.972","NCT03387683"]
["5ecbf3b5307e3d1b1f8d9c18","NCT03387683","2018-07-11","AstraZeneca","AZN","Recruiting","A Clinical Study to Investigate the Effects of Dapagliflozin on Heart Work, Heart Nutrient Uptake, and Heart Muscle Efficiency in Type 2 Diabetes Patients. (DAPACARD)","Dapagliflozin","SGLT2 Inhibitor","No",null,"No",null,"Phase 4",2,52,"Anticipated","2018-02-28","2019-04-01",{"$nulls":5},"This is a randomised, placebo-controlled, double-blind, parallel-group, international, multicentre, Phase IV study to investigate the effects of dapagliflozin on cardiac substrate uptake, myocardial efficiency and myocardial contractile work in T2D patients. Eligible subjects with T2D before randomisation and fulfilling all of the inclusion criteria and none of the exclusion criteria will be randomised in a 1:1 ratio to dapagliflozin 10 mg or placebo once daily and treated for six weeks. The study includes five visits.","The following will be assessed at Baseline and at the end of the treatment period;\n\n 1. MRI scanning in order to assess cardiac function and morphology. The MRI scanning will be made after fasting for at least 6 hours in the same time of day at all visits. The cardiac MRI examination will be performed in accordance with a pre-defined MRI protocol, with the total scan time at each visit estimated to 45 minutes. Images from all sites will be analyzed centrally at the core-lab using a dedicated software package and certified analysts.\n 2. CT-PET scanning will be made to assess myocardial function and metabolism, as well as fatty acid metabolism in brain, liver and kidney cortex. The CT-PET scanning will be made after a fast as well as abstinence from nicotine, alcohol and caffeine for at least 6 hours at the same time of day at all visits. * A cardiac 11C-Acetate PET/CT examination is performed (IV 400 MBq 11C-Acetate).\n     * A cardiac 18F-FTHA PET/CT examination is performed (IV 150 MBq 18F-FTHA). The subject is further examined by PET/CT over the liver, kidney cortex and brain (in this order) for uptake of 18F-FTHA. Arterialized venous samples are acquired throughout to assess P-NEFA and 18F-FTHA metabolism by metabolite analysis.","A Double-blind, Randomized, Parallel Group, Phase IV Study to Investigate the Effects of DAPAgliflozin on CARDiac Substrate Uptake, Myocardial Efficiency and Myocardial Contractile Work in Type 2 Diabetes Patients","D1690C00063","Diabetes Mellitus Type 2","Type 2 Diabetes","Metabolic Diseases","Nutritional Disorders","Placebo Comparator|Experimental","placebo|dapagliflozin 10mg","placebo tablets once daily|dapagliflozin 10mg tablets once daily","Drug","placebo|dapagliflozin","placebo to match dapagliflozin|dapagliflozin 10mg","Forxiga 10mg","placebo|dapagliflozin 10mg","\n\n * Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.\n * Provision of signed and dated, written informed consent form prior to any mandatory study specific procedures, sampling, and analyses.\n * Females or males â‰¥40 years up to 75 years of age.\n * Individuals with type 2 diabetes diagnosed for at least 6 months based on the American Diabetes Association standards (ADA, 2017) and on stable dose of metformin for at least 6 weeks prior to screening and HbA1c at screening visit of â‰¥42 mmol/mol (6.0%) and â‰¤75 mmol/mol (9.0%) measured at local hospital laboratory.\n * No significant signs or symptoms of coronary artery disease or, if known coronary artery disease, currently free of symptoms and a) all major epicardial vessels with <50% stenosis within 12 months prior to screening, or b) if revascularized with all major epicardial vessels with <50% remaining stenosis after stenting or bypass surgery procedure determined between 3 and 12 months prior to screening.\n * Normal left ventricular ejection fraction (â‰¥50%) assessed within 1 year prior to informed consent, and if applicable, after most recent acute episode of coronary artery syndrome, or at screening visit.\n * Body mass index (BMI) â‰¥ 25 kg/m2.\n\n","\n\n * Blood pressure at screening that would require a change in blood pressure treatment over the study period or any of the following: systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg.\n * History of stroke or other clinically significant cerebrovascular disease.\n * Any of the following cardiovascular diseases known within 3 months prior to signing the consent at enrolment: 1. Atrial fibrillation, or other unstable or severe arrhythmia affecting heart function\n    2. Unstable heart failure or any heart failure with NYHA class III and IV\n    3. Significant valvular disease\n    4. Significant peripheral artery disease\n   \n   \n * Planned cardiac surgery or angioplasty within 3 months from enrolment.\n * Clinical diagnosis of type 1 diabetes, maturity onset diabetes of the young (MODY), secondary diabetes or diabetes insipidus.\n * Verified body weight variability of >3 kg during the 3 proceeding months before screening.\n * Active malignancy requiring treatment at the time of visit 1 (with the exception of successfully treated basal cell or treated squamous cell carcinoma).\n * Patients with severe hepatic impairment (Child-Pugh class C).\n * Unstable or rapidly progressing renal disease.\n * Clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.\n * Ongoing treatment with other antidiabetic drugs than metformin.\n * Ongoing treatment with loop diuretics.\n * Ongoing weight-loss diet (hypocaloric diet) or use of weight loss agents.\n * Contraindications to dapagliflozin therapy.\n * Ongoing treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent or any other uncontrolled endocrine disorder except for T2D.\n * Previous enrolment in the present study or participation in another clinical study with an investigational product during the last 1 month prior to screening.\n * Estimated Glomerular Filtration Rate (eGFR) <45 mL/min/1.73 m2.\n * Alcohol or drug abuse within the 3 months prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to study procedures or study treatment intake.\n * Any condition when MRI and CT-PET is contraindicated such as, but not limited to, having a metallic implant (such as pacemaker or cochlear implant), permanent make up, claustrophobia or BMI â‰¥40 kg/m2).\n * Involvement in the planning and/or conduct of the study.\n * Plasma donation within one month of screening or any blood donation/blood loss >450 mL during the 3 months prior to screening.\n * Women who has a positive pregnancy test at enrolment or randomization, or are breastfeeding.",{"$nulls":4},"Actual","2018-01-02","Actual","Anticipated","2019-04-01","Anticipated","2018-07-01","2017-12-18","2017-12-22","2018-07-10","No",null,"Interventional","Treatment","Parallel Assignment","Triple (Participant, Care Provider, Investigator)","Randomized","40 Years","75 Years","All",null,"No",{"$nulls":4},"No","No",{"$nulls":17},"2017-003820-58","EudraCT Number","Global longitudinal strain of the left ventricle (GLSLV)","Change from baseline in global longitudinal strain of the left ventricle (GLSLV) in %","Baseline and 6 weeks","Myocardial efficiency|Other Pre-specified Outcome Measures:|Myocardial perfusion|Myocardial fatty acid uptake|Left atrial volumes|Left atrial ejection fraction|Left atrial transmitral flow velocity|Fatty acid uptake in the liver|Fatty acid uptake in the kidney cortex|Fatty acid uptake in the brain","Change from baseline in myocardial efficiency (%)|Other Pre-specified Outcome Measures:|Changes from baseline in myocardial perfusion measured by|Changes from baseline in myocardial fatty acid uptake measured by|Changes from baseline in Left atrial min volume and max volume,|Left atrial ejection fraction (%)|Left atrial transmitral flow velocity indices (E/A, E, A and DT)|Changes from baseline in fatty acid uptake in liver by|Changes from baseline in fatty acid uptake in kidney cortex by|Changes from baseline in fatty acid uptake in brain measured by","Baseline and 6 weeks|11C-Acetate|18F-FTHA","information.center@astrazeneca.com","AstraZeneca Clinical Study Information Center","1-877-240-9479","Turku, Finland, 20520|Uppsala, Sweden, Se-751 85",null,"Finland|Sweden","Research Site",{"$nulls":4},"2018-07-10","2020-05-25T16:35:01.808","2020-05-26T17:10:42.972","NCT03387683"]
["5ecbf3b5feab101b155307b9","NCT03387683","2018-08-07","AstraZeneca","AZN","Recruiting","A Clinical Study to Investigate the Effects of Dapagliflozin on Heart Work, Heart Nutrient Uptake, and Heart Muscle Efficiency in Type 2 Diabetes Patients. (DAPACARD)","Dapagliflozin","SGLT2 Inhibitor","No",null,"No",null,"Phase 4",2,52,"Anticipated","2018-02-28","2019-04-01",{"$nulls":5},"This is a randomised, placebo-controlled, double-blind, parallel-group, international, multicentre, Phase IV study to investigate the effects of dapagliflozin on cardiac substrate uptake, myocardial efficiency and myocardial contractile work in T2D patients. Eligible subjects with T2D before randomisation and fulfilling all of the inclusion criteria and none of the exclusion criteria will be randomised in a 1:1 ratio to dapagliflozin 10 mg or placebo once daily and treated for six weeks. The study includes five visits.","The following will be assessed at Baseline and at the end of the treatment period;\n\n 1. MRI scanning in order to assess cardiac function and morphology. The MRI scanning will be made after fasting for at least 6 hours in the same time of day at all visits. The cardiac MRI examination will be performed in accordance with a pre-defined MRI protocol, with the total scan time at each visit estimated to 45 minutes. Images from all sites will be analyzed centrally at the core-lab using a dedicated software package and certified analysts.\n 2. CT-PET scanning will be made to assess myocardial function and metabolism, as well as fatty acid metabolism in brain, liver and kidney cortex. The CT-PET scanning will be made after a fast as well as abstinence from nicotine, alcohol and caffeine for at least 6 hours at the same time of day at all visits. * A cardiac 11C-Acetate PET/CT examination is performed (IV 400 MBq 11C-Acetate).\n     * A cardiac 18F-FTHA PET/CT examination is performed (IV 150 MBq 18F-FTHA). The subject is further examined by PET/CT over the liver, kidney cortex and brain (in this order) for uptake of 18F-FTHA. Arterialized venous samples are acquired throughout to assess P-NEFA and 18F-FTHA metabolism by metabolite analysis.","A Double-blind, Randomized, Parallel Group, Phase IV Study to Investigate the Effects of DAPAgliflozin on CARDiac Substrate Uptake, Myocardial Efficiency and Myocardial Contractile Work in Type 2 Diabetes Patients","D1690C00063","Diabetes Mellitus Type 2","Type 2 Diabetes","Metabolic Diseases","Nutritional Disorders","Placebo Comparator|Experimental","placebo|dapagliflozin 10mg","placebo tablets once daily|dapagliflozin 10mg tablets once daily","Drug","placebo|dapagliflozin","placebo to match dapagliflozin|dapagliflozin 10mg","Forxiga 10mg","placebo|dapagliflozin 10mg","\n\n * Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.\n * Provision of signed and dated, written informed consent form prior to any mandatory study specific procedures, sampling, and analyses.\n * Females or males â‰¥40 years up to 75 years of age.\n * Individuals with type 2 diabetes diagnosed for at least 6 months based on the American Diabetes Association standards (ADA, 2017) and on stable dose of metformin for at least 6 weeks prior to screening and HbA1c at screening visit of â‰¥42 mmol/mol (6.0%) and â‰¤75 mmol/mol (9.0%) measured at local hospital laboratory.\n * No significant signs or symptoms of coronary artery disease or, if known coronary artery disease, currently free of symptoms and a) all major epicardial vessels with <50% stenosis within 12 months prior to screening, or b) if revascularized with all major epicardial vessels with <50% remaining stenosis after stenting or bypass surgery procedure determined between 3 and 12 months prior to screening.\n * Normal left ventricular ejection fraction (â‰¥50%) assessed within 1 year prior to informed consent, and if applicable, after most recent acute episode of coronary artery syndrome, or at screening visit.\n * Body mass index (BMI) â‰¥ 25 kg/m2.\n\n","\n\n * Blood pressure at screening that would require a change in blood pressure treatment over the study period or any of the following: systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg.\n * History of stroke or other clinically significant cerebrovascular disease.\n * Any of the following cardiovascular diseases known within 3 months prior to signing the consent at enrolment: 1. Atrial fibrillation, or other unstable or severe arrhythmia affecting heart function\n    2. Unstable heart failure or any heart failure with NYHA class III and IV\n    3. Significant valvular disease\n    4. Significant peripheral artery disease\n   \n   \n * Planned cardiac surgery or angioplasty within 3 months from enrolment.\n * Clinical diagnosis of type 1 diabetes, maturity onset diabetes of the young (MODY), secondary diabetes or diabetes insipidus.\n * Verified body weight variability of >3 kg during the 3 proceeding months before screening.\n * Active malignancy requiring treatment at the time of visit 1 (with the exception of successfully treated basal cell or treated squamous cell carcinoma).\n * Patients with severe hepatic impairment (Child-Pugh class C).\n * Unstable or rapidly progressing renal disease.\n * Clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.\n * Ongoing treatment with other antidiabetic drugs than metformin.\n * Ongoing treatment with loop diuretics.\n * Ongoing weight-loss diet (hypocaloric diet) or use of weight loss agents.\n * Contraindications to dapagliflozin therapy.\n * Ongoing treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent or any other uncontrolled endocrine disorder except for T2D.\n * Previous enrolment in the present study or participation in another clinical study with an investigational product during the last 1 month prior to screening.\n * Estimated Glomerular Filtration Rate (eGFR) <45 mL/min/1.73 m2.\n * Alcohol or drug abuse within the 3 months prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to study procedures or study treatment intake.\n * Any condition when MRI and CT-PET is contraindicated such as, but not limited to, having a metallic implant (such as pacemaker or cochlear implant), permanent make up, claustrophobia or BMI â‰¥40 kg/m2).\n * Involvement in the planning and/or conduct of the study.\n * Plasma donation within one month of screening or any blood donation/blood loss >450 mL during the 3 months prior to screening.\n * Women who has a positive pregnancy test at enrolment or randomization, or are breastfeeding.",{"$nulls":4},"Actual","2018-01-02","Actual","Anticipated","2019-04-01","Anticipated","2018-08-01","2017-12-18","2017-12-22","2018-08-06","No",null,"Interventional","Treatment","Parallel Assignment","Triple (Participant, Care Provider, Investigator)","Randomized","40 Years","75 Years","All",null,"No",{"$nulls":4},"No","No",{"$nulls":17},"2017-003820-58","EudraCT Number","Global longitudinal strain of the left ventricle (GLSLV)","Change from baseline in global longitudinal strain of the left ventricle (GLSLV) in %","Baseline and 6 weeks","Myocardial efficiency|Other Pre-specified Outcome Measures:|Myocardial perfusion|Myocardial fatty acid uptake|Left atrial volumes|Left atrial ejection fraction|Left atrial transmitral flow velocity|Fatty acid uptake in the liver|Fatty acid uptake in the kidney cortex|Fatty acid uptake in the brain","Change from baseline in myocardial efficiency (%)|Other Pre-specified Outcome Measures:|Changes from baseline in myocardial perfusion measured by|Changes from baseline in myocardial fatty acid uptake measured by|Changes from baseline in Left atrial min volume and max volume,|Left atrial ejection fraction (%)|Left atrial transmitral flow velocity indices (E/A, E, A and DT)|Changes from baseline in fatty acid uptake in liver by|Changes from baseline in fatty acid uptake in kidney cortex by|Changes from baseline in fatty acid uptake in brain measured by","Baseline and 6 weeks|11C-Acetate|18F-FTHA","information.center@astrazeneca.com","AstraZeneca Clinical Study Information Center","1-877-240-9479","Turku, Finland, 20520|Uppsala, Sweden, Se-751 85",null,"Finland|Sweden","Research Site",{"$nulls":4},"2018-08-06","2020-05-25T16:35:01.978","2020-05-26T17:10:42.972","NCT03387683"]
["5ecbf3b5fe30261b1a048188","NCT03387683","2018-09-05","AstraZeneca","AZN","Recruiting","A Clinical Study to Investigate the Effects of Dapagliflozin on Heart Work, Heart Nutrient Uptake, and Heart Muscle Efficiency in Type 2 Diabetes Patients. (DAPACARD)","Dapagliflozin","SGLT2 Inhibitor","No",null,"No",null,"Phase 4",2,52,"Anticipated","2018-02-28","2019-04-01",{"$nulls":5},"This is a randomised, placebo-controlled, double-blind, parallel-group, international, multicentre, Phase IV study to investigate the effects of dapagliflozin on cardiac substrate uptake, myocardial efficiency and myocardial contractile work in T2D patients. Eligible subjects with T2D before randomisation and fulfilling all of the inclusion criteria and none of the exclusion criteria will be randomised in a 1:1 ratio to dapagliflozin 10 mg or placebo once daily and treated for six weeks. The study includes five visits.","The following will be assessed at Baseline and at the end of the treatment period;\n\n 1. MRI scanning in order to assess cardiac function and morphology. The MRI scanning will be made after fasting for at least 6 hours in the same time of day at all visits. The cardiac MRI examination will be performed in accordance with a pre-defined MRI protocol, with the total scan time at each visit estimated to 45 minutes. Images from all sites will be analyzed centrally at the core-lab using a dedicated software package and certified analysts.\n 2. CT-PET scanning will be made to assess myocardial function and metabolism, as well as fatty acid metabolism in brain, liver and kidney cortex. The CT-PET scanning will be made after a fast as well as abstinence from nicotine, alcohol and caffeine for at least 6 hours at the same time of day at all visits. * A cardiac 11C-Acetate PET/CT examination is performed (IV 400 MBq 11C-Acetate).\n     * A cardiac 18F-FTHA PET/CT examination is performed (IV 150 MBq 18F-FTHA). The subject is further examined by PET/CT over the liver, kidney cortex and brain (in this order) for uptake of 18F-FTHA. Arterialized venous samples are acquired throughout to assess P-NEFA and 18F-FTHA metabolism by metabolite analysis.","A Double-blind, Randomized, Parallel Group, Phase IV Study to Investigate the Effects of DAPAgliflozin on CARDiac Substrate Uptake, Myocardial Efficiency and Myocardial Contractile Work in Type 2 Diabetes Patients","D1690C00063","Diabetes Mellitus Type 2","Type 2 Diabetes","Metabolic Diseases","Nutritional Disorders","Placebo Comparator|Experimental","placebo|dapagliflozin 10mg","placebo tablets once daily|dapagliflozin 10mg tablets once daily","Drug","placebo|dapagliflozin","placebo to match dapagliflozin|dapagliflozin 10mg","Forxiga 10mg","placebo|dapagliflozin 10mg","\n\n * Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.\n * Provision of signed and dated, written informed consent form prior to any mandatory study specific procedures, sampling, and analyses.\n * Females or males â‰¥40 years up to 75 years of age.\n * Individuals with type 2 diabetes diagnosed for at least 6 months based on the American Diabetes Association standards (ADA, 2017) and on stable dose of metformin for at least 6 weeks prior to screening and HbA1c at screening visit of â‰¥42 mmol/mol (6.0%) and â‰¤75 mmol/mol (9.0%) measured at local hospital laboratory.\n * No significant signs or symptoms of coronary artery disease or, if known coronary artery disease, currently free of symptoms and a) all major epicardial vessels with <50% stenosis within 12 months prior to screening, or b) if revascularized with all major epicardial vessels with <50% remaining stenosis after stenting or bypass surgery procedure determined between 3 and 12 months prior to screening.\n * Normal left ventricular ejection fraction (â‰¥50%) assessed within 1 year prior to informed consent, and if applicable, after most recent acute episode of coronary artery syndrome, or at screening visit.\n * Body mass index (BMI) â‰¥ 25 kg/m2.\n\n","\n\n * Blood pressure at screening that would require a change in blood pressure treatment over the study period or any of the following: systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg.\n * History of stroke or other clinically significant cerebrovascular disease.\n * Any of the following cardiovascular diseases known within 3 months prior to signing the consent at enrolment: 1. Atrial fibrillation, or other unstable or severe arrhythmia affecting heart function\n    2. Unstable heart failure or any heart failure with NYHA class III and IV\n    3. Significant valvular disease\n    4. Significant peripheral artery disease\n   \n   \n * Planned cardiac surgery or angioplasty within 3 months from enrolment.\n * Clinical diagnosis of type 1 diabetes, maturity onset diabetes of the young (MODY), secondary diabetes or diabetes insipidus.\n * Verified body weight variability of >3 kg during the 3 proceeding months before screening.\n * Active malignancy requiring treatment at the time of visit 1 (with the exception of successfully treated basal cell or treated squamous cell carcinoma).\n * Patients with severe hepatic impairment (Child-Pugh class C).\n * Unstable or rapidly progressing renal disease.\n * Clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.\n * Ongoing treatment with other antidiabetic drugs than metformin.\n * Ongoing treatment with loop diuretics.\n * Ongoing weight-loss diet (hypocaloric diet) or use of weight loss agents.\n * Contraindications to dapagliflozin therapy.\n * Ongoing treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent or any other uncontrolled endocrine disorder except for T2D.\n * Previous enrolment in the present study or participation in another clinical study with an investigational product during the last 1 month prior to screening.\n * Estimated Glomerular Filtration Rate (eGFR) <45 mL/min/1.73 m2.\n * Alcohol or drug abuse within the 3 months prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to study procedures or study treatment intake.\n * Any condition when MRI and CT-PET is contraindicated such as, but not limited to, having a metallic implant (such as pacemaker or cochlear implant), permanent make up, claustrophobia or BMI â‰¥40 kg/m2).\n * Involvement in the planning and/or conduct of the study.\n * Plasma donation within one month of screening or any blood donation/blood loss >450 mL during the 3 months prior to screening.\n * Women who has a positive pregnancy test at enrolment or randomization, or are breastfeeding.",{"$nulls":4},"Actual","2018-01-02","Actual","Anticipated","2019-04-01","Anticipated","2018-09-01","2017-12-18","2017-12-22","2018-09-04","No",null,"Interventional","Treatment","Parallel Assignment","Triple (Participant, Care Provider, Investigator)","Randomized","40 Years","75 Years","All",null,"No",{"$nulls":4},"No","No",{"$nulls":17},"2017-003820-58","EudraCT Number","Global longitudinal strain of the left ventricle (GLSLV)","Change from baseline in global longitudinal strain of the left ventricle (GLSLV) in %","Baseline and 6 weeks","Myocardial efficiency|Other Pre-specified Outcome Measures:|Myocardial perfusion|Myocardial fatty acid uptake|Left atrial volumes|Left atrial ejection fraction|Left atrial transmitral flow velocity|Fatty acid uptake in the liver|Fatty acid uptake in the kidney cortex|Fatty acid uptake in the brain","Change from baseline in myocardial efficiency (%)|Other Pre-specified Outcome Measures:|Changes from baseline in myocardial perfusion measured by|Changes from baseline in myocardial fatty acid uptake measured by|Changes from baseline in Left atrial min volume and max volume,|Left atrial ejection fraction (%)|Left atrial transmitral flow velocity indices (E/A, E, A and DT)|Changes from baseline in fatty acid uptake in liver by|Changes from baseline in fatty acid uptake in kidney cortex by|Changes from baseline in fatty acid uptake in brain measured by","Baseline and 6 weeks|11C-Acetate|18F-FTHA","information.center@astrazeneca.com","AstraZeneca Clinical Study Information Center","1-877-240-9479","Turku, Finland, 20520|Uppsala, Sweden, Se-751 85",null,"Finland|Sweden","Research Site",{"$nulls":4},"2018-09-04","2020-05-25T16:35:01.795","2020-05-26T17:10:42.972","NCT03387683"]
["5ecbf3b511702c1b1b91699c","NCT03387683","2018-10-09","AstraZeneca","AZN","Recruiting","A Clinical Study to Investigate the Effects of Dapagliflozin on Heart Work, Heart Nutrient Uptake, and Heart Muscle Efficiency in Type 2 Diabetes Patients. (DAPACARD)","Dapagliflozin","SGLT2 Inhibitor","No",null,"No",null,"Phase 4",2,52,"Anticipated","2018-02-28","2019-04-01",{"$nulls":5},"This is a randomised, placebo-controlled, double-blind, parallel-group, international, multicentre, Phase IV study to investigate the effects of dapagliflozin on cardiac substrate uptake, myocardial efficiency and myocardial contractile work in T2D patients. Eligible subjects with T2D before randomisation and fulfilling all of the inclusion criteria and none of the exclusion criteria will be randomised in a 1:1 ratio to dapagliflozin 10 mg or placebo once daily and treated for six weeks. The study includes five visits.","The following will be assessed at Baseline and at the end of the treatment period;\n\n 1. MRI scanning in order to assess cardiac function and morphology. The MRI scanning will be made after fasting for at least 6 hours in the same time of day at all visits. The cardiac MRI examination will be performed in accordance with a pre-defined MRI protocol, with the total scan time at each visit estimated to 45 minutes. Images from all sites will be analyzed centrally at the core-lab using a dedicated software package and certified analysts.\n 2. CT-PET scanning will be made to assess myocardial function and metabolism, as well as fatty acid metabolism in brain, liver and kidney cortex. The CT-PET scanning will be made after a fast as well as abstinence from nicotine, alcohol and caffeine for at least 6 hours at the same time of day at all visits. * A cardiac 11C-Acetate PET/CT examination is performed (IV 400 MBq 11C-Acetate).\n     * A cardiac 18F-FTHA PET/CT examination is performed (IV 150 MBq 18F-FTHA). The subject is further examined by PET/CT over the liver, kidney cortex and brain (in this order) for uptake of 18F-FTHA. Arterialized venous samples are acquired throughout to assess P-NEFA and 18F-FTHA metabolism by metabolite analysis.","A Double-blind, Randomized, Parallel Group, Phase IV Study to Investigate the Effects of DAPAgliflozin on CARDiac Substrate Uptake, Myocardial Efficiency and Myocardial Contractile Work in Type 2 Diabetes Patients","D1690C00063","Diabetes Mellitus Type 2","Type 2 Diabetes","Metabolic Diseases","Nutritional Disorders","Placebo Comparator|Experimental","placebo|dapagliflozin 10mg","placebo tablets once daily|dapagliflozin 10mg tablets once daily","Drug","placebo|dapagliflozin","placebo to match dapagliflozin|dapagliflozin 10mg","Forxiga 10mg","placebo|dapagliflozin 10mg","\n\n * Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.\n * Provision of signed and dated, written informed consent form prior to any mandatory study specific procedures, sampling, and analyses.\n * Females or males â‰¥40 years up to 75 years of age.\n * Individuals with type 2 diabetes diagnosed for at least 6 months based on the American Diabetes Association standards (ADA, 2017) and on stable dose of metformin for at least 6 weeks prior to screening and HbA1c at screening visit of â‰¥42 mmol/mol (6.0%) and â‰¤75 mmol/mol (9.0%) measured at local hospital laboratory.\n * No significant signs or symptoms of coronary artery disease or, if known coronary artery disease, currently free of symptoms and a) all major epicardial vessels with <50% stenosis within 12 months prior to screening, or b) if revascularized with all major epicardial vessels with <50% remaining stenosis after stenting or bypass surgery procedure determined between 3 and 12 months prior to screening.\n * Normal left ventricular ejection fraction (â‰¥50%) assessed within 1 year prior to informed consent, and if applicable, after most recent acute episode of coronary artery syndrome, or at screening visit.\n * Body mass index (BMI) â‰¥ 25 kg/m2.\n\n","\n\n * Blood pressure at screening that would require a change in blood pressure treatment over the study period or any of the following: systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg.\n * History of stroke or other clinically significant cerebrovascular disease.\n * Any of the following cardiovascular diseases known within 3 months prior to signing the consent at enrolment: 1. Atrial fibrillation, or other unstable or severe arrhythmia affecting heart function\n    2. Unstable heart failure or any heart failure with NYHA class III and IV\n    3. Significant valvular disease\n    4. Significant peripheral artery disease\n   \n   \n * Planned cardiac surgery or angioplasty within 3 months from enrolment.\n * Clinical diagnosis of type 1 diabetes, maturity onset diabetes of the young (MODY), secondary diabetes or diabetes insipidus.\n * Verified body weight variability of >3 kg during the 3 proceeding months before screening.\n * Active malignancy requiring treatment at the time of visit 1 (with the exception of successfully treated basal cell or treated squamous cell carcinoma).\n * Patients with severe hepatic impairment (Child-Pugh class C).\n * Unstable or rapidly progressing renal disease.\n * Clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.\n * Ongoing treatment with other antidiabetic drugs than metformin.\n * Ongoing treatment with loop diuretics.\n * Ongoing weight-loss diet (hypocaloric diet) or use of weight loss agents.\n * Contraindications to dapagliflozin therapy.\n * Ongoing treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent or any other uncontrolled endocrine disorder except for T2D.\n * Previous enrolment in the present study or participation in another clinical study with an investigational product during the last 1 month prior to screening.\n * Estimated Glomerular Filtration Rate (eGFR) <45 mL/min/1.73 m2.\n * Alcohol or drug abuse within the 3 months prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to study procedures or study treatment intake.\n * Any condition when MRI and CT-PET is contraindicated such as, but not limited to, having a metallic implant (such as pacemaker or cochlear implant), permanent make up, claustrophobia or BMI â‰¥40 kg/m2).\n * Involvement in the planning and/or conduct of the study.\n * Plasma donation within one month of screening or any blood donation/blood loss >450 mL during the 3 months prior to screening.\n * Women who has a positive pregnancy test at enrolment or randomization, or are breastfeeding.",{"$nulls":4},"Actual","2018-01-02","Actual","Anticipated","2019-04-01","Anticipated","2018-10-01","2017-12-18","2017-12-22","2018-10-05","No",null,"Interventional","Treatment","Parallel Assignment","Triple (Participant, Care Provider, Investigator)","Randomized","40 Years","75 Years","All",null,"No",{"$nulls":4},"No","No",{"$nulls":17},"2017-003820-58","EudraCT Number","Global longitudinal strain of the left ventricle (GLSLV)","Change from baseline in global longitudinal strain of the left ventricle (GLSLV) in %","Baseline and 6 weeks","Myocardial efficiency|Other Pre-specified Outcome Measures:|Myocardial perfusion|Myocardial fatty acid uptake|Left atrial volumes|Left atrial ejection fraction|Left atrial transmitral flow velocity|Fatty acid uptake in the liver|Fatty acid uptake in the kidney cortex|Fatty acid uptake in the brain","Change from baseline in myocardial efficiency (%)|Other Pre-specified Outcome Measures:|Changes from baseline in myocardial perfusion measured by|Changes from baseline in myocardial fatty acid uptake measured by|Changes from baseline in Left atrial min volume and max volume,|Left atrial ejection fraction (%)|Left atrial transmitral flow velocity indices (E/A, E, A and DT)|Changes from baseline in fatty acid uptake in liver by|Changes from baseline in fatty acid uptake in kidney cortex by|Changes from baseline in fatty acid uptake in brain measured by","Baseline and 6 weeks|11C-Acetate|18F-FTHA","information.center@astrazeneca.com","AstraZeneca Clinical Study Information Center","1-877-240-9479","Turku, Finland, 20520|Uppsala, Sweden, Se-751 85",null,"Finland|Sweden","Research Site",{"$nulls":4},"2018-10-05","2020-05-25T16:35:01.936","2020-05-26T17:10:42.972","NCT03387683"]
["5ecbf3b6e2561b1b11905c85","NCT03387683","2018-11-05","AstraZeneca","AZN","Recruiting","A Clinical Study to Investigate the Effects of Dapagliflozin on Heart Work, Heart Nutrient Uptake, and Heart Muscle Efficiency in Type 2 Diabetes Patients. (DAPACARD)","Dapagliflozin","SGLT2 Inhibitor","No",null,"No",null,"Phase 4",2,52,"Anticipated","2018-02-28","2019-04-01",{"$nulls":5},"This is a randomised, placebo-controlled, double-blind, parallel-group, international, multicentre, Phase IV study to investigate the effects of dapagliflozin on cardiac substrate uptake, myocardial efficiency and myocardial contractile work in T2D patients. Eligible subjects with T2D before randomisation and fulfilling all of the inclusion criteria and none of the exclusion criteria will be randomised in a 1:1 ratio to dapagliflozin 10 mg or placebo once daily and treated for six weeks. The study includes five visits.","The following will be assessed at Baseline and at the end of the treatment period;\n\n 1. MRI scanning in order to assess cardiac function and morphology. The MRI scanning will be made after fasting for at least 6 hours in the same time of day at all visits. The cardiac MRI examination will be performed in accordance with a pre-defined MRI protocol, with the total scan time at each visit estimated to 45 minutes. Images from all sites will be analyzed centrally at the core-lab using a dedicated software package and certified analysts.\n 2. CT-PET scanning will be made to assess myocardial function and metabolism, as well as fatty acid metabolism in brain, liver and kidney cortex. The CT-PET scanning will be made after a fast as well as abstinence from nicotine, alcohol and caffeine for at least 6 hours at the same time of day at all visits. * A cardiac 11C-Acetate PET/CT examination is performed (IV 400 MBq 11C-Acetate).\n     * A cardiac 18F-FTHA PET/CT examination is performed (IV 150 MBq 18F-FTHA). The subject is further examined by PET/CT over the liver, kidney cortex and brain (in this order) for uptake of 18F-FTHA. Arterialized venous samples are acquired throughout to assess P-NEFA and 18F-FTHA metabolism by metabolite analysis.","A Double-blind, Randomized, Parallel Group, Phase IV Study to Investigate the Effects of DAPAgliflozin on CARDiac Substrate Uptake, Myocardial Efficiency and Myocardial Contractile Work in Type 2 Diabetes Patients","D1690C00063","Diabetes Mellitus Type 2","Type 2 Diabetes","Metabolic Diseases","Nutritional Disorders","Placebo Comparator|Experimental","placebo|dapagliflozin 10mg","placebo tablets once daily|dapagliflozin 10mg tablets once daily","Drug","placebo|dapagliflozin","placebo to match dapagliflozin|dapagliflozin 10mg","Forxiga 10mg","placebo|dapagliflozin 10mg","\n\n * Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.\n * Provision of signed and dated, written informed consent form prior to any mandatory study specific procedures, sampling, and analyses.\n * Females or males â‰¥40 years up to 75 years of age.\n * Individuals with type 2 diabetes diagnosed for at least 6 months based on the American Diabetes Association standards (ADA, 2017) and on stable dose of metformin for at least 6 weeks prior to screening and HbA1c at screening visit of â‰¥42 mmol/mol (6.0%) and â‰¤75 mmol/mol (9.0%) measured at local hospital laboratory.\n * No significant signs or symptoms of coronary artery disease or, if known coronary artery disease, currently free of symptoms and a) all major epicardial vessels with <50% stenosis within 12 months prior to screening, or b) if revascularized with all major epicardial vessels with <50% remaining stenosis after stenting or bypass surgery procedure determined between 3 and 12 months prior to screening.\n * Normal left ventricular ejection fraction (â‰¥50%) assessed within 1 year prior to informed consent, and if applicable, after most recent acute episode of coronary artery syndrome, or at screening visit.\n * Body mass index (BMI) â‰¥ 25 kg/m2.\n\n","\n\n * Blood pressure at screening that would require a change in blood pressure treatment over the study period or any of the following: systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg.\n * History of stroke or other clinically significant cerebrovascular disease.\n * Any of the following cardiovascular diseases known within 3 months prior to signing the consent at enrolment: 1. Atrial fibrillation, or other unstable or severe arrhythmia affecting heart function\n    2. Unstable heart failure or any heart failure with NYHA class III and IV\n    3. Significant valvular disease\n    4. Significant peripheral artery disease\n   \n   \n * Planned cardiac surgery or angioplasty within 3 months from enrolment.\n * Clinical diagnosis of type 1 diabetes, maturity onset diabetes of the young (MODY), secondary diabetes or diabetes insipidus.\n * Verified body weight variability of >3 kg during the 3 proceeding months before screening.\n * Active malignancy requiring treatment at the time of visit 1 (with the exception of successfully treated basal cell or treated squamous cell carcinoma).\n * Patients with severe hepatic impairment (Child-Pugh class C).\n * Unstable or rapidly progressing renal disease.\n * Clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.\n * Ongoing treatment with other antidiabetic drugs than metformin.\n * Ongoing treatment with loop diuretics.\n * Ongoing weight-loss diet (hypocaloric diet) or use of weight loss agents.\n * Contraindications to dapagliflozin therapy.\n * Ongoing treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent or any other uncontrolled endocrine disorder except for T2D.\n * Previous enrolment in the present study or participation in another clinical study with an investigational product during the last 1 month prior to screening.\n * Estimated Glomerular Filtration Rate (eGFR) <45 mL/min/1.73 m2.\n * Alcohol or drug abuse within the 3 months prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to study procedures or study treatment intake.\n * Any condition when MRI and CT-PET is contraindicated such as, but not limited to, having a metallic implant (such as pacemaker or cochlear implant), permanent make up, claustrophobia or BMI â‰¥40 kg/m2).\n * Involvement in the planning and/or conduct of the study.\n * Plasma donation within one month of screening or any blood donation/blood loss >450 mL during the 3 months prior to screening.\n * Women who has a positive pregnancy test at enrolment or randomization, or are breastfeeding.",{"$nulls":4},"Actual","2018-01-02","Actual","Anticipated","2019-04-01","Anticipated","2018-11-01","2017-12-18","2017-12-22","2018-11-02","No",null,"Interventional","Treatment","Parallel Assignment","Triple (Participant, Care Provider, Investigator)","Randomized","40 Years","75 Years","All",null,"No",{"$nulls":4},"No","No",{"$nulls":17},"2017-003820-58","EudraCT Number","Global longitudinal strain of the left ventricle (GLSLV)","Change from baseline in global longitudinal strain of the left ventricle (GLSLV) in %","Baseline and 6 weeks","Myocardial efficiency|Other Pre-specified Outcome Measures:|Myocardial perfusion|Myocardial fatty acid uptake|Left atrial volumes|Left atrial ejection fraction|Left atrial transmitral flow velocity|Fatty acid uptake in the liver|Fatty acid uptake in the kidney cortex|Fatty acid uptake in the brain","Change from baseline in myocardial efficiency (%)|Other Pre-specified Outcome Measures:|Changes from baseline in myocardial perfusion measured by|Changes from baseline in myocardial fatty acid uptake measured by|Changes from baseline in Left atrial min volume and max volume,|Left atrial ejection fraction (%)|Left atrial transmitral flow velocity indices (E/A, E, A and DT)|Changes from baseline in fatty acid uptake in liver by|Changes from baseline in fatty acid uptake in kidney cortex by|Changes from baseline in fatty acid uptake in brain measured by","Baseline and 6 weeks|11C-Acetate|18F-FTHA","information.center@astrazeneca.com","AstraZeneca Clinical Study Information Center","1-877-240-9479","Turku, Finland, 20520|Uppsala, Sweden, Se-751 85",null,"Finland|Sweden","Research Site",{"$nulls":4},"2018-11-02","2020-05-25T16:35:02.211","2020-05-26T17:10:42.972","NCT03387683"]
["5ecbf3b5e2561b1b11905c84","NCT03387683","2018-12-03","AstraZeneca","AZN","Recruiting","A Clinical Study to Investigate the Effects of Dapagliflozin on Heart Work, Heart Nutrient Uptake, and Heart Muscle Efficiency in Type 2 Diabetes Patients (DAPACARD)","Dapagliflozin","SGLT2 Inhibitor","No",null,"No",null,"Phase 4",2,52,"Anticipated","2018-02-28","2019-04-01",{"$nulls":5},"This is a randomised, placebo-controlled, double-blind, parallel-group, international, multicentre, Phase IV study to investigate the effects of dapagliflozin on cardiac substrate uptake, myocardial efficiency and myocardial contractile work in T2D patients. Eligible subjects with T2D before randomisation and fulfilling all of the inclusion criteria and none of the exclusion criteria will be randomised in a 1:1 ratio to dapagliflozin 10 mg or placebo once daily and treated for six weeks. The study includes five visits.","The following will be assessed at Baseline and at the end of the treatment period;\n\n 1. MRI scanning in order to assess cardiac function and morphology. The MRI scanning will be made after fasting for at least 6 hours in the same time of day at all visits. The cardiac MRI examination will be performed in accordance with a pre-defined MRI protocol, with the total scan time at each visit estimated to 45 minutes. Images from all sites will be analyzed centrally at the core-lab using a dedicated software package and certified analysts.\n 2. CT-PET scanning will be made to assess myocardial function and metabolism, as well as fatty acid metabolism in brain, liver and kidney cortex. The CT-PET scanning will be made after a fast as well as abstinence from nicotine, alcohol and caffeine for at least 6 hours at the same time of day at all visits. * A cardiac 11C-Acetate PET/CT examination is performed (IV 400 MBq 11C-Acetate).\n     * A cardiac 18F-FTHA PET/CT examination is performed (IV 150 MBq 18F-FTHA). The subject is further examined by PET/CT over the liver, kidney cortex and brain (in this order) for uptake of 18F-FTHA. Arterialized venous samples are acquired throughout to assess P-NEFA and 18F-FTHA metabolism by metabolite analysis.","A Double-blind, Randomized, Parallel Group, Phase IV Study to Investigate the Effects of DAPAgliflozin on CARDiac Substrate Uptake, Myocardial Efficiency and Myocardial Contractile Work in Type 2 Diabetes Patients","D1690C00063","Diabetes Mellitus Type 2","Type 2 Diabetes","Metabolic Diseases","Nutritional Disorders","Placebo Comparator|Experimental","placebo|dapagliflozin 10mg","placebo tablets once daily|dapagliflozin 10mg tablets once daily","Drug","placebo|dapagliflozin","placebo to match dapagliflozin|dapagliflozin 10mg","Forxiga 10mg","placebo|dapagliflozin 10mg","\n\n * Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.\n * Provision of signed and dated, written informed consent form prior to any mandatory study specific procedures, sampling, and analyses.\n * Females or males â‰¥40 years up to 75 years of age.\n * Individuals with type 2 diabetes diagnosed for at least 6 months based on the American Diabetes Association standards (ADA, 2017) and on stable dose of metformin for at least 6 weeks prior to screening and HbA1c at screening visit of â‰¥42 mmol/mol (6.0%) and â‰¤75 mmol/mol (9.0%) measured at local hospital laboratory.\n * No significant signs or symptoms of coronary artery disease or, if known coronary artery disease, currently free of symptoms and a) all major epicardial vessels with <50% stenosis within 12 months prior to screening, or b) if revascularized with all major epicardial vessels with <50% remaining stenosis after stenting or bypass surgery procedure determined between 3 and 12 months prior to screening.\n * Normal left ventricular ejection fraction (â‰¥50%) assessed within 1 year prior to informed consent, and if applicable, after most recent acute episode of coronary artery syndrome, or at screening visit.\n * Body mass index (BMI) â‰¥ 25 kg/m2.\n\n","\n\n * Blood pressure at screening that would require a change in blood pressure treatment over the study period or any of the following: systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg.\n * History of stroke or other clinically significant cerebrovascular disease.\n * Any of the following cardiovascular diseases known within 3 months prior to signing the consent at enrolment: 1. Atrial fibrillation, or other unstable or severe arrhythmia affecting heart function\n    2. Unstable heart failure or any heart failure with NYHA class III and IV\n    3. Significant valvular disease\n    4. Significant peripheral artery disease\n   \n   \n * Planned cardiac surgery or angioplasty within 3 months from enrolment.\n * Clinical diagnosis of type 1 diabetes, maturity onset diabetes of the young (MODY), secondary diabetes or diabetes insipidus.\n * Verified body weight variability of >3 kg during the 3 proceeding months before screening.\n * Active malignancy requiring treatment at the time of visit 1 (with the exception of successfully treated basal cell or treated squamous cell carcinoma).\n * Patients with severe hepatic impairment (Child-Pugh class C).\n * Unstable or rapidly progressing renal disease.\n * Clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.\n * Ongoing treatment with other antidiabetic drugs than metformin.\n * Ongoing treatment with loop diuretics.\n * Ongoing weight-loss diet (hypocaloric diet) or use of weight loss agents.\n * Contraindications to dapagliflozin therapy.\n * Ongoing treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent or any other uncontrolled endocrine disorder except for T2D.\n * Previous enrolment in the present study or participation in another clinical study with an investigational product during the last 1 month prior to screening.\n * Estimated Glomerular Filtration Rate (eGFR) <45 mL/min/1.73 m2.\n * Alcohol or drug abuse within the 3 months prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to study procedures or study treatment intake.\n * Any condition when MRI and CT-PET is contraindicated such as, but not limited to, having a metallic implant (such as pacemaker or cochlear implant), permanent make up, claustrophobia or BMI â‰¥40 kg/m2).\n * Involvement in the planning and/or conduct of the study.\n * Plasma donation within one month of screening or any blood donation/blood loss >450 mL during the 3 months prior to screening.\n * Women who has a positive pregnancy test at enrolment or randomization, or are breastfeeding.",{"$nulls":4},"Actual","2018-01-02","Actual","Anticipated","2019-04-01","Anticipated","2018-11-01","2017-12-18","2017-12-22","2018-11-30","No",null,"Interventional","Treatment","Parallel Assignment","Triple (Participant, Care Provider, Investigator)","Randomized","40 Years","75 Years","All",null,"No",{"$nulls":4},"No","No",{"$nulls":17},"2017-003820-58","EudraCT Number","Global longitudinal strain of the left ventricle (GLSLV)","Change from baseline in global longitudinal strain of the left ventricle (GLSLV) in %","Baseline and 6 weeks","Myocardial efficiency|Other Pre-specified Outcome Measures:|Myocardial perfusion|Myocardial fatty acid uptake|Left atrial volumes|Left atrial ejection fraction|Left atrial transmitral flow velocity|Fatty acid uptake in the liver|Fatty acid uptake in the kidney cortex|Fatty acid uptake in the brain","Change from baseline in myocardial efficiency (%)|Other Pre-specified Outcome Measures:|Changes from baseline in myocardial perfusion measured by|Changes from baseline in myocardial fatty acid uptake measured by|Changes from baseline in Left atrial min volume and max volume,|Left atrial ejection fraction (%)|Left atrial transmitral flow velocity indices (E/A, E, A and DT)|Changes from baseline in fatty acid uptake in liver by|Changes from baseline in fatty acid uptake in kidney cortex by|Changes from baseline in fatty acid uptake in brain measured by","Baseline and 6 weeks|11C-Acetate|18F-FTHA","information.center@astrazeneca.com","AstraZeneca Clinical Study Information Center","1-877-240-9479","Turku, Finland, 20520|Uppsala, Sweden, Se-751 85",null,"Finland|Sweden","Research Site",{"$nulls":4},"2018-11-30","2020-05-25T16:35:01.961","2020-05-26T17:10:42.972","NCT03387683"]
["5ecbf3b6307e3d1b1f8d9c19","NCT03387683","2019-01-03","AstraZeneca","AZN","Recruiting","A Clinical Study to Investigate the Effects of Dapagliflozin on Heart Work, Heart Nutrient Uptake, and Heart Muscle Efficiency in Type 2 Diabetes Patients (DAPACARD)","Dapagliflozin","SGLT2 Inhibitor","No",null,"No",null,"Phase 4",2,52,"Anticipated","2018-02-28","2019-04-01",{"$nulls":5},"This is a randomised, placebo-controlled, double-blind, parallel-group, international, multicentre, Phase IV study to investigate the effects of dapagliflozin on cardiac substrate uptake, myocardial efficiency and myocardial contractile work in T2D patients. Eligible subjects with T2D before randomisation and fulfilling all of the inclusion criteria and none of the exclusion criteria will be randomised in a 1:1 ratio to dapagliflozin 10 mg or placebo once daily and treated for six weeks. The study includes five visits.","The following will be assessed at Baseline and at the end of the treatment period;\n\n 1. MRI scanning in order to assess cardiac function and morphology. The MRI scanning will be made after fasting for at least 6 hours in the same time of day at all visits. The cardiac MRI examination will be performed in accordance with a pre-defined MRI protocol, with the total scan time at each visit estimated to 45 minutes. Images from all sites will be analyzed centrally at the core-lab using a dedicated software package and certified analysts.\n 2. CT-PET scanning will be made to assess myocardial function and metabolism, as well as fatty acid metabolism in brain, liver and kidney cortex. The CT-PET scanning will be made after a fast as well as abstinence from nicotine, alcohol and caffeine for at least 6 hours at the same time of day at all visits. * A cardiac 11C-Acetate PET/CT examination is performed (IV 400 MBq 11C-Acetate).\n     * A cardiac 18F-FTHA PET/CT examination is performed (IV 150 MBq 18F-FTHA). The subject is further examined by PET/CT over the liver, kidney cortex and brain (in this order) for uptake of 18F-FTHA. Arterialized venous samples are acquired throughout to assess P-NEFA and 18F-FTHA metabolism by metabolite analysis.","A Double-blind, Randomized, Parallel Group, Phase IV Study to Investigate the Effects of DAPAgliflozin on CARDiac Substrate Uptake, Myocardial Efficiency and Myocardial Contractile Work in Type 2 Diabetes Patients","D1690C00063","Diabetes Mellitus Type 2","Type 2 Diabetes","Metabolic Diseases","Nutritional Disorders","Placebo Comparator|Experimental","placebo|dapagliflozin 10mg","placebo tablets once daily|dapagliflozin 10mg tablets once daily","Drug","placebo|dapagliflozin","placebo to match dapagliflozin|dapagliflozin 10mg","Forxiga 10mg","placebo|dapagliflozin 10mg","\n\n * Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.\n * Provision of signed and dated, written informed consent form prior to any mandatory study specific procedures, sampling, and analyses.\n * Females or males â‰¥40 years up to 75 years of age.\n * Individuals with type 2 diabetes diagnosed for at least 6 months based on the American Diabetes Association standards (ADA, 2017) and on stable dose of metformin for at least 6 weeks prior to screening and HbA1c at screening visit of â‰¥42 mmol/mol (6.0%) and â‰¤75 mmol/mol (9.0%) measured at local hospital laboratory.\n * No significant signs or symptoms of coronary artery disease or, if known coronary artery disease, currently free of symptoms and a) all major epicardial vessels with <50% stenosis within 12 months prior to screening, or b) if revascularized with all major epicardial vessels with <50% remaining stenosis after stenting or bypass surgery procedure determined between 3 and 12 months prior to screening.\n * Normal left ventricular ejection fraction (â‰¥50%) assessed within 1 year prior to informed consent, and if applicable, after most recent acute episode of coronary artery syndrome, or at screening visit.\n * Body mass index (BMI) â‰¥ 25 kg/m2.\n\n","\n\n * Blood pressure at screening that would require a change in blood pressure treatment over the study period or any of the following: systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg.\n * History of stroke or other clinically significant cerebrovascular disease.\n * Any of the following cardiovascular diseases known within 3 months prior to signing the consent at enrolment: 1. Atrial fibrillation, or other unstable or severe arrhythmia affecting heart function\n    2. Unstable heart failure or any heart failure with NYHA class III and IV\n    3. Significant valvular disease\n    4. Significant peripheral artery disease\n   \n   \n * Planned cardiac surgery or angioplasty within 3 months from enrolment.\n * Clinical diagnosis of type 1 diabetes, maturity onset diabetes of the young (MODY), secondary diabetes or diabetes insipidus.\n * Verified body weight variability of >3 kg during the 3 proceeding months before screening.\n * Active malignancy requiring treatment at the time of visit 1 (with the exception of successfully treated basal cell or treated squamous cell carcinoma).\n * Patients with severe hepatic impairment (Child-Pugh class C).\n * Unstable or rapidly progressing renal disease.\n * Clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.\n * Ongoing treatment with other antidiabetic drugs than metformin.\n * Ongoing treatment with loop diuretics.\n * Ongoing weight-loss diet (hypocaloric diet) or use of weight loss agents.\n * Contraindications to dapagliflozin therapy.\n * Ongoing treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent or any other uncontrolled endocrine disorder except for T2D.\n * Previous enrolment in the present study or participation in another clinical study with an investigational product during the last 1 month prior to screening.\n * Estimated Glomerular Filtration Rate (eGFR) <45 mL/min/1.73 m2.\n * Alcohol or drug abuse within the 3 months prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to study procedures or study treatment intake.\n * Any condition when MRI and CT-PET is contraindicated such as, but not limited to, having a metallic implant (such as pacemaker or cochlear implant), permanent make up, claustrophobia or BMI â‰¥40 kg/m2).\n * Involvement in the planning and/or conduct of the study.\n * Plasma donation within one month of screening or any blood donation/blood loss >450 mL during the 3 months prior to screening.\n * Women who has a positive pregnancy test at enrolment or randomization, or are breastfeeding.",{"$nulls":4},"Actual","2018-01-02","Actual","Anticipated","2019-04-01","Anticipated","2019-01-01","2017-12-18","2017-12-22","2019-01-02","No",null,"Interventional","Treatment","Parallel Assignment","Triple (Participant, Care Provider, Investigator)","Randomized","40 Years","75 Years","All",null,"No",{"$nulls":4},"No","No",{"$nulls":17},"2017-003820-58","EudraCT Number","Global longitudinal strain of the left ventricle (GLSLV)","Change from baseline in global longitudinal strain of the left ventricle (GLSLV) in %","Baseline and 6 weeks","Myocardial efficiency|Other Pre-specified Outcome Measures:|Myocardial perfusion|Myocardial fatty acid uptake|Left atrial volumes|Left atrial ejection fraction|Left atrial transmitral flow velocity|Fatty acid uptake in the liver|Fatty acid uptake in the kidney cortex|Fatty acid uptake in the brain","Change from baseline in myocardial efficiency (%)|Other Pre-specified Outcome Measures:|Changes from baseline in myocardial perfusion measured by|Changes from baseline in myocardial fatty acid uptake measured by|Changes from baseline in Left atrial min volume and max volume,|Left atrial ejection fraction (%)|Left atrial transmitral flow velocity indices (E/A, E, A and DT)|Changes from baseline in fatty acid uptake in liver by|Changes from baseline in fatty acid uptake in kidney cortex by|Changes from baseline in fatty acid uptake in brain measured by","Baseline and 6 weeks|11C-Acetate|18F-FTHA","information.center@astrazeneca.com","AstraZeneca Clinical Study Information Center","1-877-240-9479","Turku, Finland, 20520|Uppsala, Sweden, Se-751 85",null,"Finland|Sweden","Research Site",{"$nulls":4},"2019-01-02","2020-05-25T16:35:02.117","2020-05-26T17:10:42.972","NCT03387683"]
["5ecbf3b6fe30261b1a048189","NCT03387683","2019-02-05","AstraZeneca","AZN","Recruiting","A Clinical Study to Investigate the Effects of Dapagliflozin on Heart Work, Heart Nutrient Uptake, and Heart Muscle Efficiency in Type 2 Diabetes Patients (DAPACARD)","Dapagliflozin","SGLT2 Inhibitor","No",null,"No",null,"Phase 4",2,52,"Anticipated","2018-02-28","2019-04-01",{"$nulls":5},"This is a randomised, placebo-controlled, double-blind, parallel-group, international, multicentre, Phase IV study to investigate the effects of dapagliflozin on cardiac substrate uptake, myocardial efficiency and myocardial contractile work in T2D patients. Eligible subjects with T2D before randomisation and fulfilling all of the inclusion criteria and none of the exclusion criteria will be randomised in a 1:1 ratio to dapagliflozin 10 mg or placebo once daily and treated for six weeks. The study includes five visits.","The following will be assessed at Baseline and at the end of the treatment period;\n\n 1. MRI scanning in order to assess cardiac function and morphology. The MRI scanning will be made after fasting for at least 6 hours in the same time of day at all visits. The cardiac MRI examination will be performed in accordance with a pre-defined MRI protocol, with the total scan time at each visit estimated to 45 minutes. Images from all sites will be analyzed centrally at the core-lab using a dedicated software package and certified analysts.\n 2. CT-PET scanning will be made to assess myocardial function and metabolism, as well as fatty acid metabolism in brain, liver and kidney cortex. The CT-PET scanning will be made after a fast as well as abstinence from nicotine, alcohol and caffeine for at least 6 hours at the same time of day at all visits. * A cardiac 11C-Acetate PET/CT examination is performed (IV 400 MBq 11C-Acetate).\n     * A cardiac 18F-FTHA PET/CT examination is performed (IV 150 MBq 18F-FTHA). The subject is further examined by PET/CT over the liver, kidney cortex and brain (in this order) for uptake of 18F-FTHA. Arterialized venous samples are acquired throughout to assess P-NEFA and 18F-FTHA metabolism by metabolite analysis","A Double-blind, Randomized, Parallel Group, Phase IV Study to Investigate the Effects of DAPAgliflozin on CARDiac Substrate Uptake, Myocardial Efficiency and Myocardial Contractile Work in Type 2 Diabetes Patients","D1690C00063","Diabetes Mellitus Type 2","Type 2 Diabetes","Metabolic Diseases","Nutritional Disorders","Placebo Comparator|Experimental","placebo|dapagliflozin 10mg","placebo tablets once daily|dapagliflozin 10mg tablets once daily","Drug","placebo|dapagliflozin","placebo to match dapagliflozin|dapagliflozin 10mg","Forxiga 10mg","placebo|dapagliflozin 10mg","\n\n * Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.\n * Provision of signed and dated, written informed consent form prior to any mandatory study specific procedures, sampling, and analyses.\n * Females or males â‰¥40 years up to 75 years of age.\n * Individuals with type 2 diabetes diagnosed for at least 6 months based on the American Diabetes Association standards (ADA, 2017) and on stable dose of metformin for at least 6 weeks prior to screening and HbA1c at screening visit of â‰¥42 mmol/mol (6.0%) and â‰¤75 mmol/mol (9.0%) measured at local hospital laboratory.\n * No significant signs or symptoms of coronary artery disease or, if known coronary artery disease, currently free of symptoms and a) all major epicardial vessels with <50% stenosis within 12 months prior to screening, or b) if revascularized with all major epicardial vessels with <50% remaining stenosis after stenting or bypass surgery procedure determined between 3 and 12 months prior to screening.\n * Normal left ventricular ejection fraction (â‰¥50%) assessed within 1 year prior to informed consent, and if applicable, after most recent acute episode of coronary artery syndrome, or at screening visit.\n * Body mass index (BMI) â‰¥ 25 kg/m2.\n\n","\n\n * Blood pressure at screening that would require a change in blood pressure treatment over the study period or any of the following: systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg.\n * History of stroke or other clinically significant cerebrovascular disease.\n * Any of the following cardiovascular diseases known within 3 months prior to signing the consent at enrolment: 1. Atrial fibrillation, or other unstable or severe arrhythmia affecting heart function\n    2. Unstable heart failure or any heart failure with NYHA class III and IV\n    3. Significant valvular disease\n    4. Significant peripheral artery disease\n   \n   \n * Planned cardiac surgery or angioplasty within 3 months from enrolment.\n * Clinical diagnosis of type 1 diabetes, maturity onset diabetes of the young (MODY), secondary diabetes or diabetes insipidus.\n * Verified body weight variability of >3 kg during the 3 proceeding months before screening.\n * Active malignancy requiring treatment at the time of visit 1 (with the exception of successfully treated basal cell or treated squamous cell carcinoma).\n * Patients with severe hepatic impairment (Child-Pugh class C).\n * Unstable or rapidly progressing renal disease.\n * Clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.\n * Ongoing treatment with other antidiabetic drugs than metformin.\n * Ongoing treatment with loop diuretics.\n * Ongoing weight-loss diet (hypocaloric diet) or use of weight loss agents.\n * Contraindications to dapagliflozin therapy.\n * Ongoing treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent or any other uncontrolled endocrine disorder except for T2D.\n * Previous enrolment in the present study or participation in another clinical study with an investigational product during the last 1 month prior to screening.\n * Estimated Glomerular Filtration Rate (eGFR) <45 mL/min/1.73 m2.\n * Alcohol or drug abuse within the 3 months prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to study procedures or study treatment intake.\n * Any condition when MRI and CT-PET is contraindicated such as, but not limited to, having a metallic implant (such as pacemaker or cochlear implant), permanent make up, claustrophobia or BMI â‰¥40 kg/m2).\n * Involvement in the planning and/or conduct of the study.\n * Plasma donation within one month of screening or any blood donation/blood loss >450 mL during the 3 months prior to screening.\n * Women who has a positive pregnancy test at enrolment or randomization, or are breastfeeding.",{"$nulls":4},"Actual","2018-01-02","Actual","Anticipated","2019-04-01","Anticipated","2019-01-01","2017-12-18","2017-12-22","2019-02-01","No",null,"Interventional","Treatment","Parallel Assignment","Triple (Participant, Care Provider, Investigator)","Randomized","40 Years","75 Years","All",null,"No",{"$nulls":4},"No","No",{"$nulls":17},"2017-003820-58","EudraCT Number","Global longitudinal strain of the left ventricle (GLSLV)","Change from baseline in global longitudinal strain of the left ventricle (GLSLV) in %","Baseline and 6 weeks","Myocardial efficiency|Other Pre-specified Outcome Measures:|Myocardial perfusion|Myocardial fatty acid uptake|Left atrial volumes|Left atrial ejection fraction|Left atrial transmitral flow velocity|Fatty acid uptake in the liver|Fatty acid uptake in the kidney cortex|Fatty acid uptake in the brain","Change from baseline in myocardial efficiency (%)|Other Pre-specified Outcome Measures:|Changes from baseline in myocardial perfusion measured by|Changes from baseline in myocardial fatty acid uptake measured by|Changes from baseline in Left atrial min volume and max volume,|Left atrial ejection fraction (%)|Left atrial transmitral flow velocity indices (E/A, E, A and DT)|Changes from baseline in fatty acid uptake in liver by|Changes from baseline in fatty acid uptake in kidney cortex by|Changes from baseline in fatty acid uptake in brain measured by","Baseline and 6 weeks|11C-Acetate|18F-FTHA","information.center@astrazeneca.com","AstraZeneca Clinical Study Information Center","1-877-240-9479","Turku, Finland, 20520|Uppsala, Sweden, Se-751 85",null,"Finland|Sweden","Research Site",{"$nulls":4},"2019-02-01","2020-05-25T16:35:02.051","2020-05-26T17:10:42.972","NCT03387683"]
["5ecbf3b6fe30261b1a04818a","NCT03387683","2019-02-08","AstraZeneca","AZN","Active, not recruiting","A Clinical Study to Investigate the Effects of Dapagliflozin on Heart Work, Heart Nutrient Uptake, and Heart Muscle Efficiency in Type 2 Diabetes Patients (DAPACARD)","Dapagliflozin","SGLT2 Inhibitor","No",null,"No",null,"Phase 4",2,53,"Actual","2018-02-28","2019-04-02",{"$nulls":5},"This is a randomised, placebo-controlled, double-blind, parallel-group, international, multicentre, Phase IV study to investigate the effects of dapagliflozin on cardiac substrate uptake, myocardial efficiency and myocardial contractile work in T2D patients. Eligible subjects with T2D before randomisation and fulfilling all of the inclusion criteria and none of the exclusion criteria will be randomised in a 1:1 ratio to dapagliflozin 10 mg or placebo once daily and treated for six weeks. The study includes five visits.","The following will be assessed at Baseline and at the end of the treatment period;\n\n 1. MRI scanning in order to assess cardiac function and morphology. The MRI scanning will be made after fasting for at least 6 hours in the same time of day at all visits. The cardiac MRI examination will be performed in accordance with a pre-defined MRI protocol, with the total scan time at each visit estimated to 45 minutes. Images from all sites will be analyzed centrally at the core-lab using a dedicated software package and certified analysts.\n 2. CT-PET scanning will be made to assess myocardial function and metabolism, as well as fatty acid metabolism in brain, liver and kidney cortex. The CT-PET scanning will be made after a fast as well as abstinence from nicotine, alcohol and caffeine for at least 6 hours at the same time of day at all visits. * A cardiac 11C-Acetate PET/CT examination is performed (IV 400 MBq 11C-Acetate).\n     * A cardiac 18F-FTHA PET/CT examination is performed (IV 150 MBq 18F-FTHA). The subject is further examined by PET/CT over the liver, kidney cortex and brain (in this order) for uptake of 18F-FTHA. Arterialized venous samples are acquired throughout to assess P-NEFA and 18F-FTHA metabolism by metabolite analysis","A Double-blind, Randomized, Parallel Group, Phase IV Study to Investigate the Effects of DAPAgliflozin on CARDiac Substrate Uptake, Myocardial Efficiency and Myocardial Contractile Work in Type 2 Diabetes Patients","D1690C00063","Diabetes Mellitus Type 2","Type 2 Diabetes","Metabolic Diseases","Nutritional Disorders","Placebo Comparator|Experimental","placebo|dapagliflozin 10mg","placebo tablets once daily|dapagliflozin 10mg tablets once daily","Drug","placebo|dapagliflozin","placebo to match dapagliflozin|dapagliflozin 10mg","Forxiga 10mg","placebo|dapagliflozin 10mg","\n\n * Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.\n * Provision of signed and dated, written informed consent form prior to any mandatory study specific procedures, sampling, and analyses.\n * Females or males â‰¥40 years up to 75 years of age.\n * Individuals with type 2 diabetes diagnosed for at least 6 months based on the American Diabetes Association standards (ADA, 2017) and on stable dose of metformin for at least 6 weeks prior to screening and HbA1c at screening visit of â‰¥42 mmol/mol (6.0%) and â‰¤75 mmol/mol (9.0%) measured at local hospital laboratory.\n * No significant signs or symptoms of coronary artery disease or, if known coronary artery disease, currently free of symptoms and a) all major epicardial vessels with <50% stenosis within 12 months prior to screening, or b) if revascularized with all major epicardial vessels with <50% remaining stenosis after stenting or bypass surgery procedure determined between 3 and 12 months prior to screening.\n * Normal left ventricular ejection fraction (â‰¥50%) assessed within 1 year prior to informed consent, and if applicable, after most recent acute episode of coronary artery syndrome, or at screening visit.\n * Body mass index (BMI) â‰¥ 25 kg/m2.\n\n","\n\n * Blood pressure at screening that would require a change in blood pressure treatment over the study period or any of the following: systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg.\n * History of stroke or other clinically significant cerebrovascular disease.\n * Any of the following cardiovascular diseases known within 3 months prior to signing the consent at enrolment: 1. Atrial fibrillation, or other unstable or severe arrhythmia affecting heart function\n    2. Unstable heart failure or any heart failure with NYHA class III and IV\n    3. Significant valvular disease\n    4. Significant peripheral artery disease\n   \n   \n * Planned cardiac surgery or angioplasty within 3 months from enrolment.\n * Clinical diagnosis of type 1 diabetes, maturity onset diabetes of the young (MODY), secondary diabetes or diabetes insipidus.\n * Verified body weight variability of >3 kg during the 3 proceeding months before screening.\n * Active malignancy requiring treatment at the time of visit 1 (with the exception of successfully treated basal cell or treated squamous cell carcinoma).\n * Patients with severe hepatic impairment (Child-Pugh class C).\n * Unstable or rapidly progressing renal disease.\n * Clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.\n * Ongoing treatment with other antidiabetic drugs than metformin.\n * Ongoing treatment with loop diuretics.\n * Ongoing weight-loss diet (hypocaloric diet) or use of weight loss agents.\n * Contraindications to dapagliflozin therapy.\n * Ongoing treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent or any other uncontrolled endocrine disorder except for T2D.\n * Previous enrolment in the present study or participation in another clinical study with an investigational product during the last 1 month prior to screening.\n * Estimated Glomerular Filtration Rate (eGFR) <45 mL/min/1.73 m2.\n * Alcohol or drug abuse within the 3 months prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to study procedures or study treatment intake.\n * Any condition when MRI and CT-PET is contraindicated such as, but not limited to, having a metallic implant (such as pacemaker or cochlear implant), permanent make up, claustrophobia or BMI â‰¥40 kg/m2).\n * Involvement in the planning and/or conduct of the study.\n * Plasma donation within one month of screening or any blood donation/blood loss >450 mL during the 3 months prior to screening.\n * Women who has a positive pregnancy test at enrolment or randomization, or are breastfeeding.",{"$nulls":4},"Actual","2018-01-02","Actual","Anticipated","2019-04-02","Anticipated","2019-02-01","2017-12-18","2017-12-22","2019-02-07","No",null,"Interventional","Treatment","Parallel Assignment","Triple (Participant, Care Provider, Investigator)","Randomized","40 Years","75 Years","All",null,"No",{"$nulls":4},"No","No",{"$nulls":17},"2017-003820-58","EudraCT Number","Global longitudinal strain of the left ventricle (GLSLV)","Change from baseline in global longitudinal strain of the left ventricle (GLSLV) in %","Baseline and 6 weeks","Myocardial efficiency|Other Pre-specified Outcome Measures:|Myocardial perfusion|Myocardial fatty acid uptake|Left atrial volumes|Left atrial ejection fraction|Left atrial transmitral flow velocity|Fatty acid uptake in the liver|Fatty acid uptake in the kidney cortex|Fatty acid uptake in the brain","Change from baseline in myocardial efficiency (%)|Other Pre-specified Outcome Measures:|Changes from baseline in myocardial perfusion measured by|Changes from baseline in myocardial fatty acid uptake measured by|Changes from baseline in Left atrial min volume and max volume,|Left atrial ejection fraction (%)|Left atrial transmitral flow velocity indices (E/A, E, A and DT)|Changes from baseline in fatty acid uptake in liver by|Changes from baseline in fatty acid uptake in kidney cortex by|Changes from baseline in fatty acid uptake in brain measured by","Baseline and 6 weeks|11C-Acetate|18F-FTHA",{"$nulls":3},"Turku, Finland, 20520|Uppsala, Sweden, Se-751 85",null,"Finland|Sweden","Research Site",{"$nulls":4},"2019-02-07","2020-05-25T16:35:02.510","2020-05-26T17:10:42.972","NCT03387683"]
["5ecbf3b6feab101b155307ba","NCT03387683","2019-05-09","AstraZeneca","AZN","Completed","A Clinical Study to Investigate the Effects of Dapagliflozin on Heart Work, Heart Nutrient Uptake, and Heart Muscle Efficiency in Type 2 Diabetes Patients (DAPACARD)","Dapagliflozin","SGLT2 Inhibitor","No",null,"No",null,"Phase 4",2,53,"Actual","2018-02-28","2019-03-19",{"$nulls":5},"This is a randomised, placebo-controlled, double-blind, parallel-group, international, multicentre, Phase IV study to investigate the effects of dapagliflozin on cardiac substrate uptake, myocardial efficiency and myocardial contractile work in T2D patients. Eligible subjects with T2D before randomisation and fulfilling all of the inclusion criteria and none of the exclusion criteria will be randomised in a 1:1 ratio to dapagliflozin 10 mg or placebo once daily and treated for six weeks. The study includes five visits.","The following will be assessed at Baseline and at the end of the treatment period;\n\n 1. MRI scanning in order to assess cardiac function and morphology. The MRI scanning will be made after fasting for at least 6 hours in the same time of day at all visits. The cardiac MRI examination will be performed in accordance with a pre-defined MRI protocol, with the total scan time at each visit estimated to 45 minutes. Images from all sites will be analyzed centrally at the core-lab using a dedicated software package and certified analysts.\n 2. CT-PET scanning will be made to assess myocardial function and metabolism, as well as fatty acid metabolism in brain, liver and kidney cortex. The CT-PET scanning will be made after a fast as well as abstinence from nicotine, alcohol and caffeine for at least 6 hours at the same time of day at all visits. * A cardiac 11C-Acetate PET/CT examination is performed (IV 400 MBq 11C-Acetate).\n     * A cardiac 18F-FTHA PET/CT examination is performed (IV 150 MBq 18F-FTHA). The subject is further examined by PET/CT over the liver, kidney cortex and brain (in this order) for uptake of 18F-FTHA. Arterialized venous samples are acquired throughout to assess P-NEFA and 18F-FTHA metabolism by metabolite analysis","A Double-blind, Randomized, Parallel Group, Phase IV Study to Investigate the Effects of DAPAgliflozin on CARDiac Substrate Uptake, Myocardial Efficiency and Myocardial Contractile Work in Type 2 Diabetes Patients","D1690C00063","Diabetes Mellitus Type 2","Type 2 Diabetes","Metabolic Diseases","Nutritional Disorders","Placebo Comparator|Experimental","placebo|dapagliflozin 10mg","placebo tablets once daily|dapagliflozin 10mg tablets once daily","Drug","placebo|dapagliflozin","placebo to match dapagliflozin|dapagliflozin 10mg","Forxiga 10mg","placebo|dapagliflozin 10mg","\n\n * Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.\n * Provision of signed and dated, written informed consent form prior to any mandatory study specific procedures, sampling, and analyses.\n * Females or males â‰¥40 years up to 75 years of age.\n * Individuals with type 2 diabetes diagnosed for at least 6 months based on the American Diabetes Association standards (ADA, 2017) and on stable dose of metformin for at least 6 weeks prior to screening and HbA1c at screening visit of â‰¥42 mmol/mol (6.0%) and â‰¤75 mmol/mol (9.0%) measured at local hospital laboratory.\n * No significant signs or symptoms of coronary artery disease or, if known coronary artery disease, currently free of symptoms and a) all major epicardial vessels with <50% stenosis within 12 months prior to screening, or b) if revascularized with all major epicardial vessels with <50% remaining stenosis after stenting or bypass surgery procedure determined between 3 and 12 months prior to screening.\n * Normal left ventricular ejection fraction (â‰¥50%) assessed within 1 year prior to informed consent, and if applicable, after most recent acute episode of coronary artery syndrome, or at screening visit.\n * Body mass index (BMI) â‰¥ 25 kg/m2.\n\n","\n\n * Blood pressure at screening that would require a change in blood pressure treatment over the study period or any of the following: systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg.\n * History of stroke or other clinically significant cerebrovascular disease.\n * Any of the following cardiovascular diseases known within 3 months prior to signing the consent at enrolment: 1. Atrial fibrillation, or other unstable or severe arrhythmia affecting heart function\n    2. Unstable heart failure or any heart failure with NYHA class III and IV\n    3. Significant valvular disease\n    4. Significant peripheral artery disease\n   \n   \n * Planned cardiac surgery or angioplasty within 3 months from enrolment.\n * Clinical diagnosis of type 1 diabetes, maturity onset diabetes of the young (MODY), secondary diabetes or diabetes insipidus.\n * Verified body weight variability of >3 kg during the 3 proceeding months before screening.\n * Active malignancy requiring treatment at the time of visit 1 (with the exception of successfully treated basal cell or treated squamous cell carcinoma).\n * Patients with severe hepatic impairment (Child-Pugh class C).\n * Unstable or rapidly progressing renal disease.\n * Clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.\n * Ongoing treatment with other antidiabetic drugs than metformin.\n * Ongoing treatment with loop diuretics.\n * Ongoing weight-loss diet (hypocaloric diet) or use of weight loss agents.\n * Contraindications to dapagliflozin therapy.\n * Ongoing treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent or any other uncontrolled endocrine disorder except for T2D.\n * Previous enrolment in the present study or participation in another clinical study with an investigational product during the last 1 month prior to screening.\n * Estimated Glomerular Filtration Rate (eGFR) <45 mL/min/1.73 m2.\n * Alcohol or drug abuse within the 3 months prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to study procedures or study treatment intake.\n * Any condition when MRI and CT-PET is contraindicated such as, but not limited to, having a metallic implant (such as pacemaker or cochlear implant), permanent make up, claustrophobia or BMI â‰¥40 kg/m2).\n * Involvement in the planning and/or conduct of the study.\n * Plasma donation within one month of screening or any blood donation/blood loss >450 mL during the 3 months prior to screening.\n * Women who has a positive pregnancy test at enrolment or randomization, or are breastfeeding.",{"$nulls":4},"Actual","2018-01-02","Actual","Actual","2019-03-19","Actual","2019-05-01","2017-12-18","2017-12-22","2019-05-08","No",null,"Interventional","Treatment","Parallel Assignment","Triple (Participant, Care Provider, Investigator)","Randomized","40 Years","75 Years","All",null,"No",{"$nulls":4},"No","No",{"$nulls":17},"2017-003820-58","EudraCT Number","Global longitudinal strain of the left ventricle (GLSLV)","Change from baseline in global longitudinal strain of the left ventricle (GLSLV) in %","Baseline and 6 weeks","Myocardial efficiency|Other Pre-specified Outcome Measures:|Myocardial perfusion|Myocardial fatty acid uptake|Left atrial volumes|Left atrial ejection fraction|Left atrial transmitral flow velocity|Fatty acid uptake in the liver|Fatty acid uptake in the kidney cortex|Fatty acid uptake in the brain","Change from baseline in myocardial efficiency (%)|Other Pre-specified Outcome Measures:|Changes from baseline in myocardial perfusion measured by|Changes from baseline in myocardial fatty acid uptake measured by|Changes from baseline in Left atrial min volume and max volume,|Left atrial ejection fraction (%)|Left atrial transmitral flow velocity indices (E/A, E, A and DT)|Changes from baseline in fatty acid uptake in liver by|Changes from baseline in fatty acid uptake in kidney cortex by|Changes from baseline in fatty acid uptake in brain measured by","Baseline and 6 weeks|11C-Acetate|18F-FTHA",{"$nulls":3},"Turku, Finland, 20520|Uppsala, Sweden, Se-751 85",null,"Finland|Sweden","Research Site",{"$nulls":4},"2019-05-08","2020-05-25T16:35:02.325","2020-05-26T17:10:42.972","NCT03387683"]
["5ecbf3b611702c1b1b91699d","NCT03387683","2020-03-25","AstraZeneca","AZN","Completed","A Clinical Study to Investigate the Effects of Dapagliflozin on Heart Work, Heart Nutrient Uptake, and Heart Muscle Efficiency in Type 2 Diabetes Patients (DAPACARD)","Dapagliflozin","SGLT2 Inhibitor","No",null,"No",null,"Phase 4",2,53,"Actual","2018-02-28","2019-03-19",{"$nulls":5},"This is a randomised, placebo-controlled, double-blind, parallel-group, international, multicentre, Phase IV study to investigate the effects of dapagliflozin on cardiac substrate uptake, myocardial efficiency and myocardial contractile work in T2D patients. Eligible subjects with T2D before randomisation and fulfilling all of the inclusion criteria and none of the exclusion criteria will be randomised in a 1:1 ratio to dapagliflozin 10 mg or placebo once daily and treated for six weeks. The study includes five visits.","The following will be assessed at Baseline and at the end of the treatment period;\n\n 1. MRI scanning in order to assess cardiac function and morphology. The MRI scanning will be made after fasting for at least 6 hours in the same time of day at all visits. The cardiac MRI examination will be performed in accordance with a pre-defined MRI protocol, with the total scan time at each visit estimated to 45 minutes. Images from all sites will be analyzed centrally at the core-lab using a dedicated software package and certified analysts.\n 2. CT-PET scanning will be made to assess myocardial function and metabolism, as well as fatty acid metabolism in brain, liver and kidney cortex. The CT-PET scanning will be made after a fast as well as abstinence from nicotine, alcohol and caffeine for at least 6 hours at the same time of day at all visits. * A cardiac 11C-Acetate PET/CT examination is performed (IV 400 MBq 11C-Acetate).\n     * A cardiac 18F-FTHA PET/CT examination is performed (IV 150 MBq 18F-FTHA). The subject is further examined by PET/CT over the liver, kidney cortex and brain (in this order) for uptake of 18F-FTHA. Arterialized venous samples are acquired throughout to assess P-NEFA and 18F-FTHA metabolism by metabolite analysis","A Double-blind, Randomized, Parallel Group, Phase IV Study to Investigate the Effects of DAPAgliflozin on CARDiac Substrate Uptake, Myocardial Efficiency and Myocardial Contractile Work in Type 2 Diabetes Patients","D1690C00063","Diabetes Mellitus Type 2","Type 2 Diabetes","Metabolic Diseases","Nutritional Disorders","Placebo Comparator|Experimental","placebo|dapagliflozin 10mg","placebo tablets once daily|dapagliflozin 10mg tablets once daily","Drug","placebo|dapagliflozin","placebo to match dapagliflozin|dapagliflozin 10mg","Forxiga 10mg","placebo|dapagliflozin 10mg","\n\n * Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.\n * Provision of signed and dated, written informed consent form prior to any mandatory study specific procedures, sampling, and analyses.\n * Females or males â‰¥40 years up to 75 years of age.\n * Individuals with type 2 diabetes diagnosed for at least 6 months based on the American Diabetes Association standards (ADA, 2017) and on stable dose of metformin for at least 6 weeks prior to screening and HbA1c at screening visit of â‰¥42 mmol/mol (6.0%) and â‰¤75 mmol/mol (9.0%) measured at local hospital laboratory.\n * No significant signs or symptoms of coronary artery disease or, if known coronary artery disease, currently free of symptoms and a) all major epicardial vessels with <50% stenosis within 12 months prior to screening, or b) if revascularized with all major epicardial vessels with <50% remaining stenosis after stenting or bypass surgery procedure determined between 3 and 12 months prior to screening.\n * Normal left ventricular ejection fraction (â‰¥50%) assessed within 1 year prior to informed consent, and if applicable, after most recent acute episode of coronary artery syndrome, or at screening visit.\n * Body mass index (BMI) â‰¥ 25 kg/m2.\n\n","\n\n * Blood pressure at screening that would require a change in blood pressure treatment over the study period or any of the following: systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg.\n * History of stroke or other clinically significant cerebrovascular disease.\n * Any of the following cardiovascular diseases known within 3 months prior to signing the consent at enrolment: 1. Atrial fibrillation, or other unstable or severe arrhythmia affecting heart function\n    2. Unstable heart failure or any heart failure with NYHA class III and IV\n    3. Significant valvular disease\n    4. Significant peripheral artery disease\n   \n   \n * Planned cardiac surgery or angioplasty within 3 months from enrolment.\n * Clinical diagnosis of type 1 diabetes, maturity onset diabetes of the young (MODY), secondary diabetes or diabetes insipidus.\n * Verified body weight variability of >3 kg during the 3 proceeding months before screening.\n * Active malignancy requiring treatment at the time of visit 1 (with the exception of successfully treated basal cell or treated squamous cell carcinoma).\n * Patients with severe hepatic impairment (Child-Pugh class C).\n * Unstable or rapidly progressing renal disease.\n * Clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.\n * Ongoing treatment with other antidiabetic drugs than metformin.\n * Ongoing treatment with loop diuretics.\n * Ongoing weight-loss diet (hypocaloric diet) or use of weight loss agents.\n * Contraindications to dapagliflozin therapy.\n * Ongoing treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent or any other uncontrolled endocrine disorder except for T2D.\n * Previous enrolment in the present study or participation in another clinical study with an investigational product during the last 1 month prior to screening.\n * Estimated Glomerular Filtration Rate (eGFR) <45 mL/min/1.73 m2.\n * Alcohol or drug abuse within the 3 months prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to study procedures or study treatment intake.\n * Any condition when MRI and CT-PET is contraindicated such as, but not limited to, having a metallic implant (such as pacemaker or cochlear implant), permanent make up, claustrophobia or BMI â‰¥40 kg/m2).\n * Involvement in the planning and/or conduct of the study.\n * Plasma donation within one month of screening or any blood donation/blood loss >450 mL during the 3 months prior to screening.\n * Women who has a positive pregnancy test at enrolment or randomization, or are breastfeeding.",{"$nulls":4},"Actual","2018-01-02","Actual","Actual","2019-03-19","Actual","2020-02-01","2017-12-18","2017-12-22","2020-03-11","No",null,"Interventional","Treatment","Parallel Assignment","Triple (Participant, Care Provider, Investigator)","Randomized","40 Years","75 Years","All",null,"No",null,null,"URL: https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D1690C00063&attachmentIdentifier=fab41a7e-3728-4449-af49-b295cc99007e&fileName=D1690c00063-redacted_SAP_-Final_from_PRS.pdf&versionIdentifier= [https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D1690C00063&attachmentIdentifier=fab41a7e-3728-4449-af49-b295cc99007e&fileName=D1690c00063-redacted_SAP_-Final_from_PRS.pdf&versionIdentifier=] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: redacted SAP",null,"No","No","2020-03-11","2020-03-11","2020-03-25","Actual",{"$nulls":13},"2017-003820-58","EudraCT Number",{"$nulls":9},"Turku, Finland, 20520|Uppsala, Sweden, Se-751 85",null,"Finland|Sweden","Research Site",{"$nulls":4},"2020-03-11","2020-05-25T16:35:02.475","2020-05-26T17:10:42.972","NCT03387683"]
["5ecbf3b6fe30261b1a04818b","NCT03387683","2020-04-27","AstraZeneca","AZN","Completed","A Clinical Study to Investigate the Effects of Dapagliflozin on Heart Work, Heart Nutrient Uptake, and Heart Muscle Efficiency in Type 2 Diabetes Patients (DAPACARD)","Dapagliflozin","SGLT2 Inhibitor","No",null,"No",null,"Phase 4",2,53,"Actual","2018-02-28","2019-03-19",{"$nulls":5},"This is a randomised, placebo-controlled, double-blind, parallel-group, international, multicentre, Phase IV study to investigate the effects of dapagliflozin on cardiac substrate uptake, myocardial efficiency and myocardial contractile work in T2D patients. Eligible subjects with T2D before randomisation and fulfilling all of the inclusion criteria and none of the exclusion criteria will be randomised in a 1:1 ratio to dapagliflozin 10 mg or placebo once daily and treated for six weeks. The study includes five visits.","The following will be assessed at Baseline and at the end of the treatment period;\n\n 1. MRI scanning in order to assess cardiac function and morphology. The MRI scanning will be made after fasting for at least 6 hours in the same time of day at all visits. The cardiac MRI examination will be performed in accordance with a pre-defined MRI protocol, with the total scan time at each visit estimated to 45 minutes. Images from all sites will be analyzed centrally at the core-lab using a dedicated software package and certified analysts.\n 2. CT-PET scanning will be made to assess myocardial function and metabolism, as well as fatty acid metabolism in brain, liver and kidney cortex. The CT-PET scanning will be made after a fast as well as abstinence from nicotine, alcohol and caffeine for at least 6 hours at the same time of day at all visits. * A cardiac 11C-Acetate PET/CT examination is performed (IV 400 MBq 11C-Acetate).\n     * A cardiac 18F-FTHA PET/CT examination is performed (IV 150 MBq 18F-FTHA). The subject is further examined by PET/CT over the liver, kidney cortex and brain (in this order) for uptake of 18F-FTHA. Arterialized venous samples are acquired throughout to assess P-NEFA and 18F-FTHA metabolism by metabolite analysis","A Double-blind, Randomized, Parallel Group, Phase IV Study to Investigate the Effects of DAPAgliflozin on CARDiac Substrate Uptake, Myocardial Efficiency and Myocardial Contractile Work in Type 2 Diabetes Patients","D1690C00063","Diabetes Mellitus Type 2","Type 2 Diabetes","Metabolic Diseases","Nutritional Disorders","Placebo Comparator|Experimental","placebo|dapagliflozin 10mg","placebo tablets once daily|dapagliflozin 10mg tablets once daily","Drug","placebo|dapagliflozin","placebo to match dapagliflozin|dapagliflozin 10mg","Forxiga 10mg","placebo|dapagliflozin 10mg","\n\n * Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.\n * Provision of signed and dated, written informed consent form prior to any mandatory study specific procedures, sampling, and analyses.\n * Females or males â‰¥40 years up to 75 years of age.\n * Individuals with type 2 diabetes diagnosed for at least 6 months based on the American Diabetes Association standards (ADA, 2017) and on stable dose of metformin for at least 6 weeks prior to screening and HbA1c at screening visit of â‰¥42 mmol/mol (6.0%) and â‰¤75 mmol/mol (9.0%) measured at local hospital laboratory.\n * No significant signs or symptoms of coronary artery disease or, if known coronary artery disease, currently free of symptoms and a) all major epicardial vessels with <50% stenosis within 12 months prior to screening, or b) if revascularized with all major epicardial vessels with <50% remaining stenosis after stenting or bypass surgery procedure determined between 3 and 12 months prior to screening.\n * Normal left ventricular ejection fraction (â‰¥50%) assessed within 1 year prior to informed consent, and if applicable, after most recent acute episode of coronary artery syndrome, or at screening visit.\n * Body mass index (BMI) â‰¥ 25 kg/m2.\n\n","\n\n * Blood pressure at screening that would require a change in blood pressure treatment over the study period or any of the following: systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg.\n * History of stroke or other clinically significant cerebrovascular disease.\n * Any of the following cardiovascular diseases known within 3 months prior to signing the consent at enrolment: 1. Atrial fibrillation, or other unstable or severe arrhythmia affecting heart function\n    2. Unstable heart failure or any heart failure with NYHA class III and IV\n    3. Significant valvular disease\n    4. Significant peripheral artery disease\n   \n   \n * Planned cardiac surgery or angioplasty within 3 months from enrolment.\n * Clinical diagnosis of type 1 diabetes, maturity onset diabetes of the young (MODY), secondary diabetes or diabetes insipidus.\n * Verified body weight variability of >3 kg during the 3 proceeding months before screening.\n * Active malignancy requiring treatment at the time of visit 1 (with the exception of successfully treated basal cell or treated squamous cell carcinoma).\n * Patients with severe hepatic impairment (Child-Pugh class C).\n * Unstable or rapidly progressing renal disease.\n * Clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.\n * Ongoing treatment with other antidiabetic drugs than metformin.\n * Ongoing treatment with loop diuretics.\n * Ongoing weight-loss diet (hypocaloric diet) or use of weight loss agents.\n * Contraindications to dapagliflozin therapy.\n * Ongoing treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent or any other uncontrolled endocrine disorder except for T2D.\n * Previous enrolment in the present study or participation in another clinical study with an investigational product during the last 1 month prior to screening.\n * Estimated Glomerular Filtration Rate (eGFR) <45 mL/min/1.73 m2.\n * Alcohol or drug abuse within the 3 months prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to study procedures or study treatment intake.\n * Any condition when MRI and CT-PET is contraindicated such as, but not limited to, having a metallic implant (such as pacemaker or cochlear implant), permanent make up, claustrophobia or BMI â‰¥40 kg/m2).\n * Involvement in the planning and/or conduct of the study.\n * Plasma donation within one month of screening or any blood donation/blood loss >450 mL during the 3 months prior to screening.\n * Women who has a positive pregnancy test at enrolment or randomization, or are breastfeeding.",{"$nulls":4},"Actual","2018-01-02","Actual","Actual","2019-03-19","Actual","2020-04-01","2017-12-18","2017-12-22","2020-04-15","No",null,"Interventional","Treatment","Parallel Assignment","Triple (Participant, Care Provider, Investigator)","Randomized","40 Years","75 Years","All",null,"No",null,null,"URL: https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D1690C00063&attachmentIdentifier=fab41a7e-3728-4449-af49-b295cc99007e&fileName=D1690c00063-redacted_SAP_-Final_from_PRS.pdf&versionIdentifier= [https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D1690C00063&attachmentIdentifier=fab41a7e-3728-4449-af49-b295cc99007e&fileName=D1690c00063-redacted_SAP_-Final_from_PRS.pdf&versionIdentifier=] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: redacted SAP",null,"No","No","2020-03-11","2020-03-11","2020-03-25","Actual",{"$nulls":13},"2017-003820-58","EudraCT Number",{"$nulls":9},"Turku, Finland, 20520|Uppsala, Sweden, Se-751 85",null,"Finland|Sweden","Research Site",{"$nulls":4},"2020-04-15","2020-05-25T16:35:02.949","2020-05-26T17:10:42.972","NCT03387683"]
["5ecbf3ba11702c1b1b9169a7","NCT03388749","2018-01-03","Moleculin","MBRX","Not yet recruiting","Study of Liposomal Annamycin for the Treatment of Subjects With Acute Myeloid Leukemia (AML)","Annamycin",null,"Yes","['Annamycin']","Unknown",null,"Phase 1/Phase 2",1,57,"Anticipated","2018-01-01","2019-07-01","DLT","Dose Limiting Toxicity",{"$nulls":3},"This is a multi-center, open-label, dose escalation study that will determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of liposomal annamycin as a single agent for the treatment of subjects with AML that is refractory to or relapsed after standard induction therapy",null,"Phase 1/2 Study of Liposomal Annamycin for the Treatment of Subjects With Acute Myeloid Leukemia (AML) That is Refractory to or Relapsed After Standard Induction Therapy","MB-105","Leukemia, Myeloid, Acute","Acute Leukemia|Acute Myeloid Leukemia|Myeloid Leukemia|Leukemia","Oncology Hematological","Oncology","Experimental","Liposomal annamycin",null,"Drug","Liposomal Annamycin","2-hour intravenous infusion liposomal annamycin daily for 3 consecutive days followed by 18 days off study drug (i.e., one treatment cycle = 21 days).",null,"Liposomal annamycin","\n\n 1.  A pathologically confirmed diagnosis of AML by World Health Organization (WHO) classification.\n 2.  AML that is refractory to or relapsed after standard induction therapy.\n 3.  Age â‰¥18 years at the time of signing informed consent.\n 4.  No chemotherapy, radiation, or major surgery within two weeks prior to first dose of study drug and/or recovered from the toxic side effects of that therapy, unless treatment is indicated due to progressive disease.\n 5.  No investigational therapy within four weeks of the first dose of study drug.\n 6.  Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.\n 7.  Adequate laboratory results including the following: 1. Bilirubin â‰¤1.5 times the upper limit of normal (ULN) unless due to Gilbert Syndrome\n      2. Serum glutamic-oxaloacetic transaminase (SGOT), serum glutamic-pyruvic transaminase (SGPT) and alkaline phosphatase <3 times the ULN) unless due to organ involvement\n      3. Adequate renal function (The Cockcroft-Gault equation will be used to estimate creatinine clearance. This equation is as follows: Creatinine clearance in ml/min = (140 - age) x body weight (kg)/72 x plasma creatinine (mg/dL); multiplied by 0.85 for women. Using this equation, adequate renal function will be deemed to be a creatinine clearance of greater than 60 ml/minute.)\n     \n     \n 8.  Prior anthracycline cumulative dose <50% below recommended non-cardiotoxic levels\n 9.  Subject can understand and sign the informed consent document, can communicate with the investigator, and can understand and comply with the requirements of the protocol.\n 10. Women of childbearing potential must have a negative serum or urine pregnancy test.\n 11. All men and women must agree to practice effective contraception during the entire study period and after discontinuing study drug, unless documentation of infertility exists. 1. Sexually active, fertile women must use two effective forms of contraception (abstinence, intrauterine device, oral contraceptive, or double barrier device) from the time of informed consent and until at least 6 months after discontinuing study drug\n      2. Sexually active men and their sexual partners must use effective contraceptive methods from the time of subject informed consent and until at least 3 months after discontinuing study drug\n     \n     \n\n","\n\n 1.  Subjects diagnosed with Acute Promyelocytic Leukemia.\n 2.  Concomitant therapy that includes other chemotherapy that is or may be active against AML except for prophylaxis and/or treatment of opportunistic or other infection with antibiotics, antifungals and/or antiviral agents.\n 3.  Prior mediastinal radiotherapy\n 4.  Any condition which, in the opinion of the Investigator, places the subject at unacceptable risk if he/she were to participate in the study.\n 5.  Positive risk assessment for cardiovascular disease including prior anthracycline cumulative dose more than 50% above recommended non-cardiotoxic levels, left ventricular ejection fraction (LVEF) <50%, valvular heart disease, or severe hypertension. Cardiac subjects with a New York Heart Association (NYHA) classification of 3 or 4 will be excluded. (Cardiology consultation should be requested if any question arises about cardiac function.) This also includes subjects with baseline QT/QTc interval >480 msec, a history of additional risk factors for TdP (e.g., heart failure, hypokalemia, family history of Long QT Syndrome) and using concomitant medications that significantly prolong the QT/QTc interval.\n 6.  Clinically relevant serious co-morbid medical conditions including, but not limited to, active infection, recent (less than or equal to six months) myocardial infarction, unstable angina, symptomatic congestive heart failure, uncontrolled hypertension, uncontrolled cardiac arrhythmias, chronic obstructive or chronic restrictive pulmonary disease, active CNS disease uncontrolled by standard of care, known positive status for human immunodeficiency virus (HIV) and/or active hepatitis B or C, cirrhosis, or psychiatric illness/social situations that would limit compliance with study requirements.\n 7.  Pregnant, lactating, or not using adequate contraception.\n 8.  Known allergy to anthracyclines.\n 9.  Any evidence of mucositis/stomatitis or previous history of severe (â‰¥Grade 3) mucositis from prior therapy.\n 10. Required use of strong inhibitors and inducers of CYP enzymes and transporters.",{"$nulls":4},"Actual","2018-01-03","Actual","Anticipated","2019-07-01","Anticipated","2017-12-01","2017-12-25","2017-12-25","2017-12-25","Yes",null,"Interventional","Treatment","Sequential Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No","Undecided",{"$nulls":3},"No","No",{"$nulls":19},"Dose-limiting Toxicity","Number of patients with a dose-limiting toxicity (DLT) at each dose evaluated","Day 21","Pharmacokinetics - Area under the plasma concentration|Anti-leukemic activity","Area under the plasma concentration - time curve (AUC) of annamycin and its metabolite, annamycinol|Determined by acute myeloid leukemia (AML) response rate based on the International Working Group (IWG) Response Criteria in AML (Cheson, 2003)","Day 1 and Day 3|Day 21]","ShepardRobert@hotmail.com","Robert Shepard, MD","919-271-3805",{"$nulls":7},"Robert Shepard, MD","2017-12-25","2020-05-25T16:35:06.144","2020-05-26T17:10:42.972","NCT03388749"]
["5ecbf3bafeab101b155307c3","NCT03388749","2018-05-09","Moleculin","MBRX","Not yet recruiting","Study of Liposomal Annamycin for the Treatment of Subjects With Acute Myeloid Leukemia (AML)","Annamycin",null,"Yes","['Annamycin']","Unknown",null,"Phase 1/Phase 2",1,57,"Anticipated","2018-06-01","2019-07-01","DLT","Dose Limiting Toxicity",{"$nulls":3},"This is a multi-center, open-label, dose escalation study that will determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of liposomal annamycin as a single agent for the treatment of subjects with AML that is refractory to or relapsed after standard induction therapy",null,"Phase 1/2 Study of Liposomal Annamycin for the Treatment of Subjects With Acute Myeloid Leukemia (AML) That is Refractory to or Relapsed After Standard Induction Therapy","MB-105","Leukemia, Myeloid, Acute","Acute Leukemia|Acute Myeloid Leukemia|Myeloid Leukemia|Leukemia","Oncology Hematological","Oncology","Experimental","Liposomal annamycin",null,"Drug","Liposomal Annamycin","2-hour intravenous infusion liposomal annamycin daily for 3 consecutive days followed by 18 days off study drug (i.e., one treatment cycle = 21 days).",null,"Liposomal annamycin","\n\n 1.  A pathologically confirmed diagnosis of AML by World Health Organization (WHO) classification.\n 2.  AML that is refractory to or relapsed after standard induction therapy.\n 3.  Age â‰¥18 years at the time of signing informed consent.\n 4.  No chemotherapy, radiation, or major surgery within two weeks prior to first dose of study drug and/or recovered from the toxic side effects of that therapy, unless treatment is indicated due to progressive disease.\n 5.  No investigational therapy within four weeks of the first dose of study drug.\n 6.  Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.\n 7.  Adequate laboratory results including the following: 1. Bilirubin â‰¤1.5 times the upper limit of normal (ULN) unless due to Gilbert Syndrome\n      2. Serum glutamic-oxaloacetic transaminase (SGOT), serum glutamic-pyruvic transaminase (SGPT) and alkaline phosphatase <3 times the ULN) unless due to organ involvement\n      3. Adequate renal function (The Cockcroft-Gault equation will be used to estimate creatinine clearance. This equation is as follows: Creatinine clearance in ml/min = (140 - age) x body weight (kg)/72 x plasma creatinine (mg/dL); multiplied by 0.85 for women. Using this equation, adequate renal function will be deemed to be a creatinine clearance of greater than 60 ml/minute.)\n     \n     \n 8.  Prior anthracycline cumulative dose <50% below recommended non-cardiotoxic levels\n 9.  Subject can understand and sign the informed consent document, can communicate with the investigator, and can understand and comply with the requirements of the protocol.\n 10. Women of childbearing potential must have a negative serum or urine pregnancy test.\n 11. All men and women must agree to practice effective contraception during the entire study period and after discontinuing study drug, unless documentation of infertility exists. 1. Sexually active, fertile women must use two effective forms of contraception (abstinence, intrauterine device, oral contraceptive, or double barrier device) from the time of informed consent and until at least 6 months after discontinuing study drug\n      2. Sexually active men and their sexual partners must use effective contraceptive methods from the time of subject informed consent and until at least 3 months after discontinuing study drug\n     \n     \n\n","\n\n 1.  Subjects diagnosed with Acute Promyelocytic Leukemia.\n 2.  Concomitant therapy that includes other chemotherapy that is or may be active against AML except for prophylaxis and/or treatment of opportunistic or other infection with antibiotics, antifungals and/or antiviral agents.\n 3.  Prior mediastinal radiotherapy\n 4.  Any condition which, in the opinion of the Investigator, places the subject at unacceptable risk if he/she were to participate in the study.\n 5.  Positive risk assessment for cardiovascular disease including prior anthracycline cumulative dose more than 50% above recommended non-cardiotoxic levels, left ventricular ejection fraction (LVEF) <50%, valvular heart disease, or severe hypertension. Cardiac subjects with a New York Heart Association (NYHA) classification of 3 or 4 will be excluded. (Cardiology consultation should be requested if any question arises about cardiac function.) This also includes subjects with baseline QT/QTc interval >480 msec, a history of additional risk factors for TdP (e.g., heart failure, hypokalemia, family history of Long QT Syndrome) and using concomitant medications that significantly prolong the QT/QTc interval.\n 6.  Clinically relevant serious co-morbid medical conditions including, but not limited to, active infection, recent (less than or equal to six months) myocardial infarction, unstable angina, symptomatic congestive heart failure, uncontrolled hypertension, uncontrolled cardiac arrhythmias, chronic obstructive or chronic restrictive pulmonary disease, active CNS disease uncontrolled by standard of care, known positive status for human immunodeficiency virus (HIV) and/or active hepatitis B or C, cirrhosis, or psychiatric illness/social situations that would limit compliance with study requirements.\n 7.  Pregnant, lactating, or not using adequate contraception.\n 8.  Known allergy to anthracyclines.\n 9.  Any evidence of mucositis/stomatitis or previous history of severe (â‰¥Grade 3) mucositis from prior therapy.\n 10. Required use of strong inhibitors and inducers of CYP enzymes and transporters.",{"$nulls":4},"Actual","2018-01-03","Actual","Anticipated","2019-07-01","Anticipated","2018-05-01","2017-12-25","2017-12-25","2018-05-08","Yes",null,"Interventional","Treatment","Sequential Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No","Undecided",{"$nulls":3},"No","No",{"$nulls":19},"Dose-limiting Toxicity","Number of patients with a dose-limiting toxicity (DLT) at each dose evaluated","Day 21","Pharmacokinetics - Area under the plasma concentration|Anti-leukemic activity","Area under the plasma concentration - time curve (AUC) of annamycin and its metabolite, annamycinol|Determined by acute myeloid leukemia (AML) response rate based on the International Working Group (IWG) Response Criteria in AML (Cheson, 2003)","Day 1 and Day 3|Day 21]","ShepardRobert@hotmail.com","Robert Shepard, MD","919-271-3805",{"$nulls":7},"Robert Shepard, MD","2018-05-08","2020-05-25T16:35:06.224","2020-05-26T17:10:42.972","NCT03388749"]
["5ecbf3ba307e3d1b1f8d9c24","NCT03388749","2018-06-25","Moleculin","MBRX","Not yet recruiting","Study of Liposomal Annamycin for the Treatment of Subjects With Acute Myeloid Leukemia (AML)","Annamycin",null,"Yes","['Annamycin']","Unknown",null,"Phase 1/Phase 2",1,57,"Anticipated","2018-08-01","2019-07-01","DLT","Dose Limiting Toxicity",{"$nulls":3},"This is a multi-center, open-label, dose escalation study that will determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of liposomal annamycin as a single agent for the treatment of subjects with AML that is refractory to or relapsed after standard induction therapy",null,"Phase 1/2 Study of Liposomal Annamycin for the Treatment of Subjects With Acute Myeloid Leukemia (AML) That is Refractory to or Relapsed After Standard Induction Therapy","MB-105","Leukemia, Myeloid, Acute","Acute Leukemia|Acute Myeloid Leukemia|Myeloid Leukemia|Leukemia","Oncology Hematological","Oncology","Experimental","Liposomal annamycin",null,"Drug","Liposomal Annamycin","2-hour intravenous infusion liposomal annamycin daily for 3 consecutive days followed by 18 days off study drug (i.e., one treatment cycle = 21 days).",null,"Liposomal annamycin","\n\n 1.  A pathologically confirmed diagnosis of AML by World Health Organization (WHO) classification.\n 2.  AML that is refractory to or relapsed after standard induction therapy.\n 3.  Age â‰¥18 years at the time of signing informed consent.\n 4.  No chemotherapy, radiation, or major surgery within two weeks prior to first dose of study drug and/or recovered from the toxic side effects of that therapy, unless treatment is indicated due to progressive disease.\n 5.  No investigational therapy within four weeks of the first dose of study drug.\n 6.  Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.\n 7.  Adequate laboratory results including the following: 1. Bilirubin â‰¤1.5 times the upper limit of normal (ULN) unless due to Gilbert Syndrome\n      2. Serum glutamic-oxaloacetic transaminase (SGOT), serum glutamic-pyruvic transaminase (SGPT) and alkaline phosphatase <3 times the ULN) unless due to organ involvement\n      3. Adequate renal function (The Cockcroft-Gault equation will be used to estimate creatinine clearance. This equation is as follows: Creatinine clearance in ml/min = (140 - age) x body weight (kg)/72 x plasma creatinine (mg/dL); multiplied by 0.85 for women. Using this equation, adequate renal function will be deemed to be a creatinine clearance of greater than 60 ml/minute.)\n     \n     \n 8.  Prior anthracycline cumulative dose <50% below recommended non-cardiotoxic levels\n 9.  Subject can understand and sign the informed consent document, can communicate with the investigator, and can understand and comply with the requirements of the protocol.\n 10. Women of childbearing potential must have a negative serum or urine pregnancy test.\n 11. All men and women must agree to practice effective contraception during the entire study period and after discontinuing study drug, unless documentation of infertility exists. 1. Sexually active, fertile women must use two effective forms of contraception (abstinence, intrauterine device, oral contraceptive, or double barrier device) from the time of informed consent and until at least 6 months after discontinuing study drug\n      2. Sexually active men and their sexual partners must use effective contraceptive methods from the time of subject informed consent and until at least 3 months after discontinuing study drug\n     \n     \n\n","\n\n 1.  Subjects diagnosed with Acute Promyelocytic Leukemia.\n 2.  Concomitant therapy that includes other chemotherapy that is or may be active against AML except for prophylaxis and/or treatment of opportunistic or other infection with antibiotics, antifungals and/or antiviral agents.\n 3.  Prior mediastinal radiotherapy\n 4.  Any condition which, in the opinion of the Investigator, places the subject at unacceptable risk if he/she were to participate in the study.\n 5.  Positive risk assessment for cardiovascular disease including prior anthracycline cumulative dose more than 50% above recommended non-cardiotoxic levels, left ventricular ejection fraction (LVEF) <50%, valvular heart disease, or severe hypertension. Cardiac subjects with a New York Heart Association (NYHA) classification of 3 or 4 will be excluded. (Cardiology consultation should be requested if any question arises about cardiac function.) This also includes subjects with baseline QT/QTc interval >480 msec, a history of additional risk factors for TdP (e.g., heart failure, hypokalemia, family history of Long QT Syndrome) and using concomitant medications that significantly prolong the QT/QTc interval.\n 6.  Clinically relevant serious co-morbid medical conditions including, but not limited to, active infection, recent (less than or equal to six months) myocardial infarction, unstable angina, symptomatic congestive heart failure, uncontrolled hypertension, uncontrolled cardiac arrhythmias, chronic obstructive or chronic restrictive pulmonary disease, active CNS disease uncontrolled by standard of care, known positive status for human immunodeficiency virus (HIV) and/or active hepatitis B or C, cirrhosis, or psychiatric illness/social situations that would limit compliance with study requirements.\n 7.  Pregnant, lactating, or not using adequate contraception.\n 8.  Known allergy to anthracyclines.\n 9.  Any evidence of mucositis/stomatitis or previous history of severe (â‰¥Grade 3) mucositis from prior therapy.\n 10. Required use of strong inhibitors and inducers of CYP enzymes and transporters.",{"$nulls":4},"Actual","2018-01-03","Actual","Anticipated","2019-07-01","Anticipated","2018-06-01","2017-12-25","2017-12-25","2018-06-20","Yes",null,"Interventional","Treatment","Sequential Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No","Undecided",{"$nulls":3},"No","No",{"$nulls":19},"Dose-limiting Toxicity","Number of patients with a dose-limiting toxicity (DLT) at each dose evaluated","Day 21","Pharmacokinetics - Area under the plasma concentration|Anti-leukemic activity","Area under the plasma concentration - time curve (AUC) of annamycin and its metabolite, annamycinol|Determined by acute myeloid leukemia (AML) response rate based on the International Working Group (IWG) Response Criteria in AML (Cheson, 2003)","Day 1 and Day 3|Day 21]","ShepardRobert@hotmail.com","Robert Shepard, MD","919-271-3805",{"$nulls":7},"Robert Shepard, MD","2018-06-20","2020-05-25T16:35:06.704","2020-05-26T17:10:42.972","NCT03388749"]
["5ecbf3bae2561b1b11905c8f","NCT03388749","2018-12-06","Moleculin","MBRX","Not yet recruiting","Study of Liposomal Annamycin for the Treatment of Subjects With Acute Myeloid Leukemia (AML)","Annamycin",null,"Yes","['Annamycin']","Unknown",null,"Phase 1/Phase 2",1,57,"Anticipated","2018-12-01","2019-07-01","DLT","Dose Limiting Toxicity",{"$nulls":3},"This is a multi-center, open-label, dose escalation study that will determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of liposomal annamycin as a single agent for the treatment of subjects with AML that is refractory to or relapsed after standard induction therapy",null,"Phase 1/2 Study of Liposomal Annamycin for the Treatment of Subjects With Acute Myeloid Leukemia (AML) That is Refractory to or Relapsed After Standard Induction Therapy","MB-105","Leukemia, Myeloid, Acute","Acute Leukemia|Acute Myeloid Leukemia|Myeloid Leukemia|Leukemia","Oncology Hematological","Oncology","Experimental","Liposomal annamycin",null,"Drug","Liposomal Annamycin","2-hour intravenous infusion liposomal annamycin daily for 3 consecutive days followed by 18 days off study drug (i.e., one treatment cycle = 21 days).",null,"Liposomal annamycin","\n\n 1.  A pathologically confirmed diagnosis of AML by World Health Organization (WHO) classification.\n 2.  AML that is refractory to or relapsed after standard induction therapy.\n 3.  Age â‰¥18 years at the time of signing informed consent.\n 4.  No chemotherapy, radiation, or major surgery within two weeks prior to first dose of study drug and/or recovered from the toxic side effects of that therapy, unless treatment is indicated due to progressive disease.\n 5.  No investigational therapy within four weeks of the first dose of study drug.\n 6.  Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.\n 7.  Adequate laboratory results including the following: 1. Bilirubin â‰¤1.5 times the upper limit of normal (ULN) unless due to Gilbert Syndrome\n      2. Serum glutamic-oxaloacetic transaminase (SGOT), serum glutamic-pyruvic transaminase (SGPT) and alkaline phosphatase <3 times the ULN) unless due to organ involvement\n      3. Adequate renal function (The Cockcroft-Gault equation will be used to estimate creatinine clearance. This equation is as follows: Creatinine clearance in ml/min = (140 - age) x body weight (kg)/72 x plasma creatinine (mg/dL); multiplied by 0.85 for women. Using this equation, adequate renal function will be deemed to be a creatinine clearance of greater than 60 ml/minute.)\n     \n     \n 8.  Prior anthracycline cumulative dose <50% below recommended non-cardiotoxic levels\n 9.  Subject can understand and sign the informed consent document, can communicate with the investigator, and can understand and comply with the requirements of the protocol.\n 10. Women of childbearing potential must have a negative serum or urine pregnancy test.\n 11. All men and women must agree to practice effective contraception during the entire study period and after discontinuing study drug, unless documentation of infertility exists. 1. Sexually active, fertile women must use two effective forms of contraception (abstinence, intrauterine device, oral contraceptive, or double barrier device) from the time of informed consent and until at least 6 months after discontinuing study drug\n      2. Sexually active men and their sexual partners must use effective contraceptive methods from the time of subject informed consent and until at least 3 months after discontinuing study drug\n     \n     \n\n","\n\n 1.  Subjects diagnosed with Acute Promyelocytic Leukemia.\n 2.  Concomitant therapy that includes other chemotherapy that is or may be active against AML except for prophylaxis and/or treatment of opportunistic or other infection with antibiotics, antifungals and/or antiviral agents.\n 3.  Prior mediastinal radiotherapy\n 4.  Any condition which, in the opinion of the Investigator, places the subject at unacceptable risk if he/she were to participate in the study.\n 5.  Positive risk assessment for cardiovascular disease including prior anthracycline cumulative dose more than 50% above recommended non-cardiotoxic levels, left ventricular ejection fraction (LVEF) <50%, valvular heart disease, or severe hypertension. Cardiac subjects with a New York Heart Association (NYHA) classification of 3 or 4 will be excluded. (Cardiology consultation should be requested if any question arises about cardiac function.) This also includes subjects with baseline QT/QTc interval >480 msec, a history of additional risk factors for TdP (e.g., heart failure, hypokalemia, family history of Long QT Syndrome) and using concomitant medications that significantly prolong the QT/QTc interval.\n 6.  Clinically relevant serious co-morbid medical conditions including, but not limited to, active infection, recent (less than or equal to six months) myocardial infarction, unstable angina, symptomatic congestive heart failure, uncontrolled hypertension, uncontrolled cardiac arrhythmias, chronic obstructive or chronic restrictive pulmonary disease, active CNS disease uncontrolled by standard of care, known positive status for human immunodeficiency virus (HIV) and/or active hepatitis B or C, cirrhosis, or psychiatric illness/social situations that would limit compliance with study requirements.\n 7.  Pregnant, lactating, or not using adequate contraception.\n 8.  Known allergy to anthracyclines.\n 9.  Any evidence of mucositis/stomatitis or previous history of severe (â‰¥Grade 3) mucositis from prior therapy.\n 10. Required use of strong inhibitors and inducers of CYP enzymes and transporters.",{"$nulls":4},"Actual","2018-01-03","Actual","Anticipated","2019-07-01","Anticipated","2018-06-01","2017-12-25","2017-12-25","2018-12-05","Yes",null,"Interventional","Treatment","Sequential Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No","Undecided",{"$nulls":3},"No","No",{"$nulls":19},"Dose-limiting Toxicity","Number of patients with a dose-limiting toxicity (DLT) at each dose evaluated","Day 21","Pharmacokinetics - Area under the plasma concentration|Anti-leukemic activity","Area under the plasma concentration - time curve (AUC) of annamycin and its metabolite, annamycinol|Determined by acute myeloid leukemia (AML) response rate based on the International Working Group (IWG) Response Criteria in AML (Cheson, 2003)","Day 1 and Day 3|Day 21]","ShepardRobert@hotmail.com","Robert Shepard, MD","919-271-3805",{"$nulls":7},"Robert Shepard, MD","2018-12-05","2020-05-25T16:35:06.250","2020-05-26T17:10:42.972","NCT03388749"]
["5ecbf3bafeab101b155307c5","NCT03388749","2018-12-17","Moleculin","MBRX","Recruiting","Study of Liposomal Annamycin for the Treatment of Subjects With Acute Myeloid Leukemia (AML)","Annamycin",null,"Yes","['Annamycin']","Unknown",null,"Phase 1/Phase 2",1,57,"Anticipated","2018-12-01","2019-07-01","DLT","Dose Limiting Toxicity",{"$nulls":3},"This is a multi-center, open-label, dose escalation study that will determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of liposomal annamycin as a single agent for the treatment of subjects with AML that is refractory to or relapsed after standard induction therapy",null,"Phase 1/2 Study of Liposomal Annamycin for the Treatment of Subjects With Acute Myeloid Leukemia (AML) That is Refractory to or Relapsed After Standard Induction Therapy","MB-105","Leukemia, Myeloid, Acute","Acute Leukemia|Acute Myeloid Leukemia|Myeloid Leukemia|Leukemia","Oncology Hematological","Oncology","Experimental","Liposomal annamycin",null,"Drug","Liposomal Annamycin","2-hour intravenous infusion liposomal annamycin daily for 3 consecutive days followed by 18 days off study drug (i.e., one treatment cycle = 21 days).",null,"Liposomal annamycin","\n\n 1.  A pathologically confirmed diagnosis of AML by World Health Organization (WHO) classification.\n 2.  AML that is refractory to or relapsed after standard induction therapy.\n 3.  Age â‰¥18 years at the time of signing informed consent.\n 4.  No chemotherapy, radiation, or major surgery within two weeks prior to first dose of study drug and/or recovered from the toxic side effects of that therapy, unless treatment is indicated due to progressive disease.\n 5.  No investigational therapy within four weeks of the first dose of study drug.\n 6.  Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.\n 7.  Adequate laboratory results including the following: 1. Bilirubin â‰¤1.5 times the upper limit of normal (ULN) unless due to Gilbert Syndrome\n      2. Serum glutamic-oxaloacetic transaminase (SGOT), serum glutamic-pyruvic transaminase (SGPT) and alkaline phosphatase <3 times the ULN) unless due to organ involvement\n      3. Adequate renal function (The Cockcroft-Gault equation will be used to estimate creatinine clearance. This equation is as follows: Creatinine clearance in ml/min = (140 - age) x body weight (kg)/72 x plasma creatinine (mg/dL); multiplied by 0.85 for women. Using this equation, adequate renal function will be deemed to be a creatinine clearance of greater than 60 ml/minute.)\n     \n     \n 8.  Prior anthracycline cumulative dose <50% below recommended non-cardiotoxic levels\n 9.  Subject can understand and sign the informed consent document, can communicate with the investigator, and can understand and comply with the requirements of the protocol.\n 10. Women of childbearing potential must have a negative serum or urine pregnancy test.\n 11. All men and women must agree to practice effective contraception during the entire study period and after discontinuing study drug, unless documentation of infertility exists. 1. Sexually active, fertile women must use two effective forms of contraception (abstinence, intrauterine device, oral contraceptive, or double barrier device) from the time of informed consent and until at least 6 months after discontinuing study drug\n      2. Sexually active men and their sexual partners must use effective contraceptive methods from the time of subject informed consent and until at least 3 months after discontinuing study drug\n     \n     \n\n","\n\n 1.  Subjects diagnosed with Acute Promyelocytic Leukemia.\n 2.  Concomitant therapy that includes other chemotherapy that is or may be active against AML except for prophylaxis and/or treatment of opportunistic or other infection with antibiotics, antifungals and/or antiviral agents.\n 3.  Prior mediastinal radiotherapy\n 4.  Any condition which, in the opinion of the Investigator, places the subject at unacceptable risk if he/she were to participate in the study.\n 5.  Positive risk assessment for cardiovascular disease including prior anthracycline cumulative dose more than 50% above recommended non-cardiotoxic levels, left ventricular ejection fraction (LVEF) <50%, valvular heart disease, or severe hypertension. Cardiac subjects with a New York Heart Association (NYHA) classification of 3 or 4 will be excluded. (Cardiology consultation should be requested if any question arises about cardiac function.) This also includes subjects with baseline QT/QTc interval >480 msec, a history of additional risk factors for TdP (e.g., heart failure, hypokalemia, family history of Long QT Syndrome) and using concomitant medications that significantly prolong the QT/QTc interval.\n 6.  Clinically relevant serious co-morbid medical conditions including, but not limited to, active infection, recent (less than or equal to six months) myocardial infarction, unstable angina, symptomatic congestive heart failure, uncontrolled hypertension, uncontrolled cardiac arrhythmias, chronic obstructive or chronic restrictive pulmonary disease, active CNS disease uncontrolled by standard of care, known positive status for human immunodeficiency virus (HIV) and/or active hepatitis B or C, cirrhosis, or psychiatric illness/social situations that would limit compliance with study requirements.\n 7.  Pregnant, lactating, or not using adequate contraception.\n 8.  Known allergy to anthracyclines.\n 9.  Any evidence of mucositis/stomatitis or previous history of severe (â‰¥Grade 3) mucositis from prior therapy.\n 10. Required use of strong inhibitors and inducers of CYP enzymes and transporters.",{"$nulls":4},"Actual","2018-01-03","Actual","Anticipated","2019-07-01","Anticipated","2018-12-01","2017-12-25","2017-12-25","2018-12-13","Yes",null,"Interventional","Treatment","Sequential Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No","Undecided",{"$nulls":3},"No","No",{"$nulls":19},"Dose-limiting Toxicity","Number of patients with a dose-limiting toxicity (DLT) at each dose evaluated","Day 21","Pharmacokinetics - Area under the plasma concentration|Anti-leukemic activity","Area under the plasma concentration - time curve (AUC) of annamycin and its metabolite, annamycinol|Determined by acute myeloid leukemia (AML) response rate based on the International Working Group (IWG) Response Criteria in AML (Cheson, 2003)","Day 1 and Day 3|Day 21]","ShepardRobert@hotmail.com","Robert Shepard, MD","919-271-3805","PoznaÅ„, Poland",null,"Poland","Szpital Kliniczny Przemienienia PaÅ„skiego Uniwersytetu Medycznego Im. Karola Marcinkowskiego",{"$nulls":3},"Robert Shepard, MD","2018-12-13","2020-05-25T16:35:06.874","2020-05-26T17:10:42.972","NCT03388749"]
["5ecbf3bafeab101b155307c4","NCT03388749","2019-01-24","Moleculin","MBRX","Recruiting","Study of Liposomal Annamycin for the Treatment of Subjects With Acute Myeloid Leukemia (AML)","Annamycin",null,"Yes","['Annamycin']","Unknown",null,"Phase 1/Phase 2",1,57,"Anticipated","2018-12-17","2019-07-01","DLT","Dose Limiting Toxicity",{"$nulls":3},"This is a multi-center, open-label, dose escalation study that will determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of liposomal annamycin as a single agent for the treatment of subjects with AML that is refractory to or relapsed after standard induction therapy",null,"Phase 1/2 Study of Liposomal Annamycin for the Treatment of Subjects With Acute Myeloid Leukemia (AML) That is Refractory to or Relapsed After Standard Induction Therapy","MB-105","Leukemia, Myeloid, Acute","Acute Leukemia|Acute Myeloid Leukemia|Myeloid Leukemia|Leukemia","Oncology Hematological","Oncology","Experimental","Liposomal annamycin",null,"Drug","Liposomal Annamycin","2-hour intravenous infusion liposomal annamycin daily for 3 consecutive days followed by 18 days off study drug (i.e., one treatment cycle = 21 days).",null,"Liposomal annamycin","\n\n 1.  A pathologically confirmed diagnosis of AML by World Health Organization (WHO) classification.\n 2.  AML that is refractory to or relapsed after standard induction therapy.\n 3.  Age â‰¥18 years at the time of signing informed consent.\n 4.  No chemotherapy, radiation, or major surgery within two weeks prior to first dose of study drug and/or recovered from the toxic side effects of that therapy, unless treatment is indicated due to progressive disease.\n 5.  No investigational therapy within four weeks of the first dose of study drug.\n 6.  Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.\n 7.  Adequate laboratory results including the following: 1. Bilirubin â‰¤1.5 times the upper limit of normal (ULN) unless due to Gilbert Syndrome\n      2. Serum glutamic-oxaloacetic transaminase (SGOT), serum glutamic-pyruvic transaminase (SGPT) and alkaline phosphatase <3 times the ULN) unless due to organ involvement\n      3. Adequate renal function (The Cockcroft-Gault equation will be used to estimate creatinine clearance. This equation is as follows: Creatinine clearance in ml/min = (140 - age) x body weight (kg)/72 x plasma creatinine (mg/dL); multiplied by 0.85 for women. Using this equation, adequate renal function will be deemed to be a creatinine clearance of greater than 60 ml/minute.)\n     \n     \n 8.  Prior anthracycline cumulative dose <50% below recommended non-cardiotoxic levels\n 9.  Subject can understand and sign the informed consent document, can communicate with the investigator, and can understand and comply with the requirements of the protocol.\n 10. Women of childbearing potential must have a negative serum or urine pregnancy test.\n 11. All men and women must agree to practice effective contraception during the entire study period and after discontinuing study drug, unless documentation of infertility exists. 1. Sexually active, fertile women must use two effective forms of contraception (abstinence, intrauterine device, oral contraceptive, or double barrier device) from the time of informed consent and until at least 6 months after discontinuing study drug\n      2. Sexually active men and their sexual partners must use effective contraceptive methods from the time of subject informed consent and until at least 3 months after discontinuing study drug\n     \n     \n\n","\n\n 1.  Subjects diagnosed with Acute Promyelocytic Leukemia.\n 2.  Concomitant therapy that includes other chemotherapy that is or may be active against AML except for prophylaxis and/or treatment of opportunistic or other infection with antibiotics, antifungals and/or antiviral agents.\n 3.  Prior mediastinal radiotherapy\n 4.  Any condition which, in the opinion of the Investigator, places the subject at unacceptable risk if he/she were to participate in the study.\n 5.  Positive risk assessment for cardiovascular disease including prior anthracycline cumulative dose more than 50% above recommended non-cardiotoxic levels, left ventricular ejection fraction (LVEF) <50%, valvular heart disease, or severe hypertension. Cardiac subjects with a New York Heart Association (NYHA) classification of 3 or 4 will be excluded. (Cardiology consultation should be requested if any question arises about cardiac function.) This also includes subjects with baseline QT/QTc interval >480 msec, a history of additional risk factors for TdP (e.g., heart failure, hypokalemia, family history of Long QT Syndrome) and using concomitant medications that significantly prolong the QT/QTc interval.\n 6.  Clinically relevant serious co-morbid medical conditions including, but not limited to, active infection, recent (less than or equal to six months) myocardial infarction, unstable angina, symptomatic congestive heart failure, uncontrolled hypertension, uncontrolled cardiac arrhythmias, chronic obstructive or chronic restrictive pulmonary disease, active CNS disease uncontrolled by standard of care, known positive status for human immunodeficiency virus (HIV) and/or active hepatitis B or C, cirrhosis, or psychiatric illness/social situations that would limit compliance with study requirements.\n 7.  Pregnant, lactating, or not using adequate contraception.\n 8.  Known allergy to anthracyclines.\n 9.  Any evidence of mucositis/stomatitis or previous history of severe (â‰¥Grade 3) mucositis from prior therapy.\n 10. Required use of strong inhibitors and inducers of CYP enzymes and transporters.",{"$nulls":4},"Actual","2018-01-03","Actual","Anticipated","2019-07-01","Anticipated","2019-01-01","2017-12-25","2017-12-25","2019-01-22","Yes",null,"Interventional","Treatment","Sequential Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No","Undecided",{"$nulls":3},"No","No",{"$nulls":19},"Dose-limiting Toxicity","Number of patients with a dose-limiting toxicity (DLT) at each dose evaluated","Day 21","Pharmacokinetics - Area under the plasma concentration|Anti-leukemic activity","Area under the plasma concentration - time curve (AUC) of annamycin and its metabolite, annamycinol|Determined by acute myeloid leukemia (AML) response rate based on the International Working Group (IWG) Response Criteria in AML (Cheson, 2003)","Day 1 and Day 3|Day 21]","ShepardRobert@hotmail.com","Robert Shepard, MD","919-271-3805","PoznaÅ„, Poland",null,"Poland","Szpital Kliniczny Przemienienia PaÅ„skiego Uniwersytetu Medycznego Im. Karola Marcinkowskiego",{"$nulls":3},"Robert Shepard, MD","2019-01-22","2020-05-25T16:35:06.353","2020-05-26T17:10:42.972","NCT03388749"]
["5ecbf3bafe30261b1a048194","NCT03388749","2019-08-26","Moleculin","MBRX","Recruiting","Study of Liposomal Annamycin for the Treatment of Subjects With Acute Myeloid Leukemia (AML)","Annamycin",null,"Yes","['Annamycin']","Unknown",null,"Phase 1/Phase 2",1,57,"Anticipated","2018-12-17","2021-02-01","DLT","Dose Limiting Toxicity",{"$nulls":3},"This is a multi-center, open-label, dose escalation study that will determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of liposomal annamycin as a single agent for the treatment of subjects with AML that is refractory to or relapsed after standard induction therapy",null,"Phase 1/2 Study of Liposomal Annamycin for the Treatment of Subjects With Acute Myeloid Leukemia (AML) That is Refractory to or Relapsed After Standard Induction Therapy","MB-105","Leukemia, Myeloid, Acute","Acute Leukemia|Acute Myeloid Leukemia|Myeloid Leukemia|Leukemia","Oncology Hematological","Oncology","Experimental","Liposomal annamycin",null,"Drug","Liposomal Annamycin","2-hour intravenous infusion liposomal annamycin daily for 3 consecutive days followed by 18 days off study drug (i.e., one treatment cycle = 21 days).",null,"Liposomal annamycin","\n\n 1.  A pathologically confirmed diagnosis of AML by World Health Organization (WHO) classification.\n 2.  AML that is refractory to or relapsed after standard induction therapy.\n 3.  Age â‰¥18 years at the time of signing informed consent.\n 4.  No chemotherapy, radiation, or major surgery within two weeks prior to first dose of study drug and/or recovered from the toxic side effects of that therapy, unless treatment is indicated due to progressive disease.\n 5.  No investigational therapy within four weeks of the first dose of study drug.\n 6.  Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.\n 7.  Adequate laboratory results including the following: 1. Bilirubin â‰¤1.5 times the upper limit of normal (ULN) unless due to Gilbert Syndrome\n      2. Serum glutamic-oxaloacetic transaminase (SGOT), serum glutamic-pyruvic transaminase (SGPT) and alkaline phosphatase <3 times the ULN) unless due to organ involvement\n      3. Adequate renal function (The Cockcroft-Gault equation will be used to estimate creatinine clearance. This equation is as follows: Creatinine clearance in ml/min = (140 - age) x body weight (kg)/72 x plasma creatinine (mg/dL); multiplied by 0.85 for women. Using this equation, adequate renal function will be deemed to be a creatinine clearance of greater than 60 ml/minute.)\n     \n     \n 8.  Prior anthracycline cumulative dose <50% below recommended non-cardiotoxic levels\n 9.  Subject can understand and sign the informed consent document, can communicate with the investigator, and can understand and comply with the requirements of the protocol.\n 10. Women of childbearing potential must have a negative serum or urine pregnancy test.\n 11. All men and women must agree to practice effective contraception during the entire study period and after discontinuing study drug, unless documentation of infertility exists. 1. Sexually active, fertile women must use two effective forms of contraception (abstinence, intrauterine device, oral contraceptive, or double barrier device) from the time of informed consent and until at least 6 months after discontinuing study drug\n      2. Sexually active men and their sexual partners must use effective contraceptive methods from the time of subject informed consent and until at least 3 months after discontinuing study drug\n     \n     \n\n","\n\n 1.  Subjects diagnosed with Acute Promyelocytic Leukemia.\n 2.  Concomitant therapy that includes other chemotherapy that is or may be active against AML except for prophylaxis and/or treatment of opportunistic or other infection with antibiotics, antifungals and/or antiviral agents.\n 3.  Prior mediastinal radiotherapy\n 4.  Any condition which, in the opinion of the Investigator, places the subject at unacceptable risk if he/she were to participate in the study.\n 5.  Positive risk assessment for cardiovascular disease including prior anthracycline cumulative dose more than 50% above recommended non-cardiotoxic levels, left ventricular ejection fraction (LVEF) <50%, valvular heart disease, or severe hypertension. Cardiac subjects with a New York Heart Association (NYHA) classification of 3 or 4 will be excluded. (Cardiology consultation should be requested if any question arises about cardiac function.) This also includes subjects with baseline QT/QTc interval >480 msec, a history of additional risk factors for TdP (e.g., heart failure, hypokalemia, family history of Long QT Syndrome) and using concomitant medications that significantly prolong the QT/QTc interval.\n 6.  Clinically relevant serious co-morbid medical conditions including, but not limited to, active infection, recent (less than or equal to six months) myocardial infarction, unstable angina, symptomatic congestive heart failure, uncontrolled hypertension, uncontrolled cardiac arrhythmias, chronic obstructive or chronic restrictive pulmonary disease, active CNS disease uncontrolled by standard of care, known positive status for human immunodeficiency virus (HIV) and/or active hepatitis B or C, cirrhosis, or psychiatric illness/social situations that would limit compliance with study requirements.\n 7.  Pregnant, lactating, or not using adequate contraception.\n 8.  Known allergy to anthracyclines.\n 9.  Any evidence of mucositis/stomatitis or previous history of severe (â‰¥Grade 3) mucositis from prior therapy.\n 10. Required use of strong inhibitors and inducers of CYP enzymes and transporters.",{"$nulls":4},"Actual","2018-01-03","Actual","Anticipated","2021-12-01","Anticipated","2019-08-01","2017-12-25","2017-12-25","2019-08-21","Yes",null,"Interventional","Treatment","Sequential Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No","Undecided",{"$nulls":3},"No","No",{"$nulls":19},"Dose-limiting Toxicity","Number of patients with a dose-limiting toxicity (DLT) at each dose evaluated","Day 21","Pharmacokinetics - Area under the plasma concentration|Anti-leukemic activity","Area under the plasma concentration - time curve (AUC) of annamycin and its metabolite, annamycinol|Determined by acute myeloid leukemia (AML) response rate based on the International Working Group (IWG) Response Criteria in AML (Cheson, 2003)","Day 1 and Day 3|Day 21]","ShepardRobert@hotmail.com","Robert Shepard, MD","919-271-3805","PoznaÅ„, Poland",null,"Poland","Szpital Kliniczny Przemienienia PaÅ„skiego Uniwersytetu Medycznego Im. Karola Marcinkowskiego",{"$nulls":3},"Robert Shepard, MD","2019-08-21","2020-05-25T16:35:06.690","2020-05-26T17:10:42.972","NCT03388749"]
["5ecbf3bae2561b1b11905c90","NCT03388749","2019-12-30","Moleculin","MBRX","Recruiting","Study of Liposomal Annamycin for the Treatment of Subjects With Acute Myeloid Leukemia (AML)","Annamycin",null,"Yes","['Annamycin']","Unknown",null,"Phase 1/Phase 2",1,57,"Anticipated","2018-12-17","2021-02-01","DLT","Dose Limiting Toxicity",{"$nulls":3},"This is a multi-center, open-label, dose escalation study that will determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of liposomal annamycin as a single agent for the treatment of subjects with AML that is refractory to or relapsed after standard induction therapy",null,"Phase 1/2 Study of Liposomal Annamycin for the Treatment of Subjects With Acute Myeloid Leukemia (AML) That is Refractory to or Relapsed After Standard Induction Therapy","MB-105","Leukemia, Myeloid, Acute","Acute Leukemia|Acute Myeloid Leukemia|Myeloid Leukemia|Leukemia","Oncology Hematological","Oncology","Experimental","Liposomal annamycin",null,"Drug","Liposomal Annamycin","2-hour intravenous infusion liposomal annamycin daily for 3 consecutive days followed by 18 days off study drug (i.e., one treatment cycle = 21 days).",null,"Liposomal annamycin","\n\n 1.  A pathologically confirmed diagnosis of AML by World Health Organization (WHO) classification.\n 2.  AML that is refractory to or relapsed after standard induction therapy.\n 3.  Age â‰¥18 years at the time of signing informed consent.\n 4.  No chemotherapy, radiation, or major surgery within two weeks prior to first dose of study drug and/or recovered from the toxic side effects of that therapy, unless treatment is indicated due to progressive disease.\n 5.  No investigational therapy within four weeks of the first dose of study drug.\n 6.  Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.\n 7.  Adequate laboratory results including the following: 1. Bilirubin â‰¤1.5 times the upper limit of normal (ULN) unless due to Gilbert Syndrome\n      2. Serum glutamic-oxaloacetic transaminase (SGOT), serum glutamic-pyruvic transaminase (SGPT) and alkaline phosphatase <3 times the ULN) unless due to organ involvement\n      3. Adequate renal function (The Cockcroft-Gault equation will be used to estimate creatinine clearance. This equation is as follows: Creatinine clearance in ml/min = (140 - age) x body weight (kg)/72 x plasma creatinine (mg/dL); multiplied by 0.85 for women. Using this equation, adequate renal function will be deemed to be a creatinine clearance of greater than 60 ml/minute.)\n     \n     \n 8.  Prior anthracycline cumulative dose <50% below recommended non-cardiotoxic levels\n 9.  Subject can understand and sign the informed consent document, can communicate with the investigator, and can understand and comply with the requirements of the protocol.\n 10. Women of childbearing potential must have a negative serum or urine pregnancy test.\n 11. All men and women must agree to practice effective contraception during the entire study period and after discontinuing study drug, unless documentation of infertility exists. 1. Sexually active, fertile women must use two effective forms of contraception (abstinence, intrauterine device, oral contraceptive, or double barrier device) from the time of informed consent and until at least 6 months after discontinuing study drug\n      2. Sexually active men and their sexual partners must use effective contraceptive methods from the time of subject informed consent and until at least 3 months after discontinuing study drug\n     \n     \n\n","\n\n 1.  Subjects diagnosed with Acute Promyelocytic Leukemia.\n 2.  Concomitant therapy that includes other chemotherapy that is or may be active against AML except for prophylaxis and/or treatment of opportunistic or other infection with antibiotics, antifungals and/or antiviral agents.\n 3.  Prior mediastinal radiotherapy\n 4.  Any condition which, in the opinion of the Investigator, places the subject at unacceptable risk if he/she were to participate in the study.\n 5.  Positive risk assessment for cardiovascular disease including prior anthracycline cumulative dose more than 50% above recommended non-cardiotoxic levels, left ventricular ejection fraction (LVEF) <50%, valvular heart disease, or severe hypertension. Cardiac subjects with a New York Heart Association (NYHA) classification of 3 or 4 will be excluded. (Cardiology consultation should be requested if any question arises about cardiac function.) This also includes subjects with baseline QT/QTc interval >480 msec, a history of additional risk factors for TdP (e.g., heart failure, hypokalemia, family history of Long QT Syndrome) and using concomitant medications that significantly prolong the QT/QTc interval.\n 6.  Clinically relevant serious co-morbid medical conditions including, but not limited to, active infection, recent (less than or equal to six months) myocardial infarction, unstable angina, symptomatic congestive heart failure, uncontrolled hypertension, uncontrolled cardiac arrhythmias, chronic obstructive or chronic restrictive pulmonary disease, active CNS disease uncontrolled by standard of care, known positive status for human immunodeficiency virus (HIV) and/or active hepatitis B or C, cirrhosis, or psychiatric illness/social situations that would limit compliance with study requirements.\n 7.  Pregnant, lactating, or not using adequate contraception.\n 8.  Known allergy to anthracyclines.\n 9.  Any evidence of mucositis/stomatitis or previous history of severe (â‰¥Grade 3) mucositis from prior therapy.\n 10. Required use of strong inhibitors and inducers of CYP enzymes and transporters.",{"$nulls":4},"Actual","2018-01-03","Actual","Anticipated","2021-12-01","Anticipated","2019-12-01","2017-12-25","2017-12-25","2019-12-26","Yes",null,"Interventional","Treatment","Sequential Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No","Undecided",{"$nulls":3},"No","No",{"$nulls":19},"Dose-limiting Toxicity","Number of patients with a dose-limiting toxicity (DLT) at each dose evaluated","Day 21","Pharmacokinetics - Area under the plasma concentration|Anti-leukemic activity","Area under the plasma concentration - time curve (AUC) of annamycin and its metabolite, annamycinol|Determined by acute myeloid leukemia (AML) response rate based on the International Working Group (IWG) Response Criteria in AML (Cheson, 2003)","Day 1 and Day 3|Day 21]","ShepardRobert@hotmail.com","Robert Shepard, MD","919-271-3805","PoznaÅ„, Poland",null,"Poland","Szpital Kliniczny Przemienienia PaÅ„skiego Uniwersytetu Medycznego Im. Karola Marcinkowskiego",{"$nulls":3},"Robert Shepard, MD","2019-12-26","2020-05-25T16:35:06.759","2020-05-26T17:10:42.972","NCT03388749"]
["5ecbf3ba11702c1b1b9169a8","NCT03388749","2020-02-20","Moleculin","MBRX","Recruiting","Study of Liposomal Annamycin for the Treatment of Subjects With Acute Myeloid Leukemia (AML)","Annamycin",null,"Yes","['Annamycin']","Unknown",null,"Phase 1/Phase 2",1,57,"Anticipated","2018-12-17","2021-02-01","DLT","Dose Limiting Toxicity",{"$nulls":3},"This is a multi-center, open-label, dose escalation study that will determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of liposomal annamycin as a single agent for the treatment of subjects with AML that is refractory to or relapsed after standard induction therapy",null,"Phase 1/2 Study of Liposomal Annamycin for the Treatment of Subjects With Acute Myeloid Leukemia (AML) That is Refractory to or Relapsed After Standard Induction Therapy","MB-105","Leukemia, Myeloid, Acute","Acute Leukemia|Acute Myeloid Leukemia|Myeloid Leukemia|Leukemia","Oncology Hematological","Oncology","Experimental","Liposomal annamycin",null,"Drug","Liposomal Annamycin","2-hour intravenous infusion liposomal annamycin daily for 3 consecutive days followed by 18 days off study drug (i.e., one treatment cycle = 21 days).",null,"Liposomal annamycin","\n\n 1.  A pathologically confirmed diagnosis of AML by World Health Organization (WHO) classification.\n 2.  AML that is refractory to or relapsed after standard induction therapy.\n 3.  Age â‰¥18 years at the time of signing informed consent.\n 4.  No chemotherapy, radiation, or major surgery within two weeks prior to first dose of study drug and/or recovered from the toxic side effects of that therapy, unless treatment is indicated due to progressive disease.\n 5.  No investigational therapy within four weeks of the first dose of study drug.\n 6.  Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.\n 7.  Adequate laboratory results including the following: 1. Bilirubin â‰¤1.5 times the upper limit of normal (ULN) unless due to Gilbert Syndrome\n      2. Serum glutamic-oxaloacetic transaminase (SGOT), serum glutamic-pyruvic transaminase (SGPT) and alkaline phosphatase <3 times the ULN) unless due to organ involvement\n      3. Adequate renal function (The Cockcroft-Gault equation will be used to estimate creatinine clearance. This equation is as follows: Creatinine clearance in ml/min = (140 - age) x body weight (kg)/72 x plasma creatinine (mg/dL); multiplied by 0.85 for women. Using this equation, adequate renal function will be deemed to be a creatinine clearance of greater than 60 ml/minute.)\n     \n     \n 8.  Prior anthracycline cumulative dose <50% below recommended non-cardiotoxic levels\n 9.  Subject can understand and sign the informed consent document, can communicate with the investigator, and can understand and comply with the requirements of the protocol.\n 10. Women of childbearing potential must have a negative serum or urine pregnancy test.\n 11. All men and women must agree to practice effective contraception during the entire study period and after discontinuing study drug, unless documentation of infertility exists. 1. Sexually active, fertile women must use two effective forms of contraception (abstinence, intrauterine device, oral contraceptive, or double barrier device) from the time of informed consent and until at least 6 months after discontinuing study drug\n      2. Sexually active men and their sexual partners must use effective contraceptive methods from the time of subject informed consent and until at least 3 months after discontinuing study drug\n     \n     \n\n","\n\n 1.  Subjects diagnosed with Acute Promyelocytic Leukemia.\n 2.  Concomitant therapy that includes other chemotherapy that is or may be active against AML except for prophylaxis and/or treatment of opportunistic or other infection with antibiotics, antifungals and/or antiviral agents.\n 3.  Prior mediastinal radiotherapy\n 4.  Any condition which, in the opinion of the Investigator, places the subject at unacceptable risk if he/she were to participate in the study.\n 5.  Positive risk assessment for cardiovascular disease including prior anthracycline cumulative dose more than 50% above recommended non-cardiotoxic levels, left ventricular ejection fraction (LVEF) <50%, valvular heart disease, or severe hypertension. Cardiac subjects with a New York Heart Association (NYHA) classification of 3 or 4 will be excluded. (Cardiology consultation should be requested if any question arises about cardiac function.) This also includes subjects with baseline QT/QTc interval >480 msec, a history of additional risk factors for TdP (e.g., heart failure, hypokalemia, family history of Long QT Syndrome) and using concomitant medications that significantly prolong the QT/QTc interval.\n 6.  Clinically relevant serious co-morbid medical conditions including, but not limited to, active infection, recent (less than or equal to six months) myocardial infarction, unstable angina, symptomatic congestive heart failure, uncontrolled hypertension, uncontrolled cardiac arrhythmias, chronic obstructive or chronic restrictive pulmonary disease, active CNS disease uncontrolled by standard of care, known positive status for human immunodeficiency virus (HIV) and/or active hepatitis B or C, cirrhosis, or psychiatric illness/social situations that would limit compliance with study requirements.\n 7.  Pregnant, lactating, or not using adequate contraception.\n 8.  Known allergy to anthracyclines.\n 9.  Any evidence of mucositis/stomatitis or previous history of severe (â‰¥Grade 3) mucositis from prior therapy.\n 10. Required use of strong inhibitors and inducers of CYP enzymes and transporters.",{"$nulls":4},"Actual","2018-01-03","Actual","Anticipated","2021-12-01","Anticipated","2020-02-01","2017-12-25","2017-12-25","2020-02-18","Yes",null,"Interventional","Treatment","Sequential Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No","Undecided",{"$nulls":3},"No","No",{"$nulls":19},"Dose-limiting Toxicity","Number of patients with a dose-limiting toxicity (DLT) at each dose evaluated","Day 21","Pharmacokinetics - Area under the plasma concentration|Anti-leukemic activity","Area under the plasma concentration - time curve (AUC) of annamycin and its metabolite, annamycinol|Determined by acute myeloid leukemia (AML) response rate based on the International Working Group (IWG) Response Criteria in AML (Cheson, 2003)","Day 1 and Day 3|Day 21]","ShepardRobert@hotmail.com","Robert Shepard, MD","919-271-3805","PoznaÅ„, Poland",null,"Poland","Szpital Kliniczny Przemienienia PaÅ„skiego Uniwersytetu Medycznego Im. Karola Marcinkowskiego",{"$nulls":3},"Robert Shepard, MD","2020-02-18","2020-05-25T16:35:06.704","2020-05-26T17:10:42.972","NCT03388749"]
["5ecbf3bbe2561b1b11905c92","NCT03389321","2018-01-03","Actelion","ALIOF","Not yet recruiting","Clinical Study to Investigate Effect of Macitentan on Riociguat Pharmacokinetics","Riociguat|Macitentan","sGC Stimulant|ET Antagonist","No",null,"No",null,"Phase 1",1,20,"Anticipated","2018-01-05","2018-02-02","AUC","Area Under The Curve",{"$nulls":3},"Both macitentan and riociguat are indicated in the treatment of pulmonary arterial hypertension (PAH) and may be administered concomitantly. The primary objective of this study is to evaluate the effect of macitentan administered for 11 days on the pharmacokinetics (PK) (i.e., amount and time of presence in the blood of riociguat) of a single dose of riociguat in healthy male subjects.",null,"A Single-center, Open-label, One-sequence, Two-treatment Study to Investigate the Effect of Macitentan at Steady State on the Pharmacokinetics of Riociguat in Healthy Male Subjects.","AC-055-123","Healthy Subjects","Healthy Volunteers","Healthy","Healthy","Experimental","Treatment A-B","All subjects will receive treatment A followed by treatment B. Treatment A consists of a single oral dose (1 mg) of riociguat on Day 1. Treatment B consists of a loading oral dose of 30 mg macitentan (3 tablets of 10 mg) on Day 5, then 10 mg of macitenan once daily from Day 6 to Day 15, with a concomitant administration of riociguat (1 mg) on Day 10","Drug","Riociguat (Adempas)|Macitentan (Opsumit)","Riociguat film-coated tablets for oral administration at a strength of 1 mg|Maictentan film-coated tablets for oral administration at a strength of 10 mg","ACT-064992","Treatment A-B","\n\n * Male subjects aged between 18 and 45 years (inclusive) at screening who signed informed consent prior to any study-mandated procedure;\n * Healthy on the basis of physical examination, cardiac evaluations (12-lead ECG) and laboratory tests performed at screening;\n * Body mass index of 18 to 30 Kg/m2 (inclusive) at screening;\n * Systolic blood pressure 100-145 mmHg, diastolic blood pressure 50-90 mmHg, and pulse rate 50-90 beats per minute (inclusive).\n\nKey ","\n\n * Known allergic reactions or hypersensitivity to macitentan, riociguat, any drug of the same classes, or any of their excipients;\n * Any contraindication for riociguat treatment;\n * Known hypersensitivity or allergy to natural rubber latex;\n * Previous history of fainting, collapse, syncope, orthostatic hypotension, or vasovagal reactions;\n * History or clinical evidence of any disease and/or existence of any surgical or medical condition, which might interfere with the absorption, distribution, metabolism, or excretion of the study treatments;\n * Previous treatment with any prescribed medications (including vaccines) or over the counter (OTC) medications (including herbal medicines such as St John's Wort, homeopathic preparations, vitamins, and minerals) within 3 weeks prior to first study treatment administration;\n * Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.\n\nOther protocol defined inclusion and exclusion criteria may apply.",{"$nulls":4},"Actual","2018-01-03","Actual","Anticipated","2018-02-02","Anticipated","2017-12-01","2017-12-27","2017-12-27","2017-12-27","No","pharmacokinetics\nmacitentan\nriociguat","Interventional","Other","Single Group Assignment","None (Open Label)","N/A","18 Years","45 Years","Male",null,"Yes",{"$nulls":4},"No","No",{"$nulls":17},"2017-003502-41","EudraCT Number","Area under the plasma concentration-time curve from zero to infinity [AUC(0-inf)] of riociguat|Maximum plasma concentration (Cmax) of riociguat","AUC(0-inf) of riociguat will be assessed following administration of riociguat alone or concomitantly with macitentan.|The maximum observed plasma concentration of riociguat will be assessed following administration of riociguat alone or concomitantly with macitentan.","Day 1 (pre-dose to 96 hours post-dose ), Day 10 (pre-dose to 144 hours post-dose)","Time to reach Cmax (tmax) of riociguat and its metabolite M1|Elimination half life (t1/2) of riociguat and its metabolite M1|AUC(0-t) of riociguat and its metabolite M1|AUC(0-inf) of riociguat metabolite, M1|Maximum plasma concentration (Cmax) of riociguat metabolite, M1|Trough concentration (Ctrough) of macitentan and its metabolite ACT-132577","The maximum observed time to reach Cmax of riociguat and M1 will be assessed following administration of riociguat alone or concomitantly with macitentan.|t1/2 of riociguat and M1 will be assessed following administration of riociguat alone or concomitantly with macitentan.|AUC(0-t) is the area under the plasma concentration-time curve from zero to time t of the last measured concentration above the limit of quantification. It will be determined for both riociguat and its metabolite M1 following adminsitration of riociguat alone or concomitantly with macitentan.|AUC(0-inf) of M1 will be assessed following administration of riociguat alone or concomitantly with macitentan.|The maximum observed plasma concentration of M1 will be assessed following administration of riociguat alone or concomitantly with macitentan.|Ctrough of macitenatn and its metabolite ACT-132577 will be assessed during the treatment period with macitentan (Day 10 to Day 15)","Day 1 (pre-dose to 96 hours post-dose ), Day 10 (pre-dose to 144 hours post-dose)|Day 10 to Day 15 (before macitentan adminsitration) and in the morning of Day 16","clinical-trials-disclosure@actelion.com","CTD Clinical Trial Disclosure Desk",{"$nulls":8},"Shirin Bruderer, PhD","2017-12-27","2020-05-25T16:35:07.749","2020-05-26T17:10:42.972","NCT03389321"]
["5ecbf3bb11702c1b1b9169aa","NCT03389321","2018-01-05","Actelion","ALIOF","Not yet recruiting","Clinical Study to Investigate Effect of Macitentan on Riociguat Pharmacokinetics","Riociguat|Macitentan","sGC Stimulant|ET Antagonist","No",null,"No",null,"Phase 1",1,20,"Anticipated","2018-01-05","2018-02-02","AUC","Area Under The Curve",{"$nulls":3},"Both macitentan and riociguat are indicated in the treatment of pulmonary arterial hypertension (PAH) and may be administered concomitantly. The primary objective of this study is to evaluate the effect of macitentan administered for 11 days on the pharmacokinetics (PK) (i.e., amount and time of presence in the blood of riociguat) of a single dose of riociguat in healthy male subjects.",null,"A Single-center, Open-label, One-sequence, Two-treatment Study to Investigate the Effect of Macitentan at Steady State on the Pharmacokinetics of Riociguat in Healthy Male Subjects","AC-055-123","Healthy Subjects","Healthy Volunteers","Healthy","Healthy","Experimental","Treatment A-B","All subjects will receive treatment A followed by treatment B. Treatment A consists of a single oral dose (1 mg) of riociguat (Adempas) on Day 1. Treatment B consists of a loading oral dose of 30 mg macitentan (Opsumit) (3 tablets of 10 mg) on Day 5, then 10 mg of macitentan once daily from Day 6 to Day 15, with a concomitant administration of riociguat (1 mg) on Day 10.","Drug","Riociguat (Adempas)|Macitentan (Opsumit)","Riociguat film-coated tablets for oral administration at a strength of 1 mg|Macitentan film-coated tablets for oral administration at a strength of 10 mg","ACT-064992","Treatment A-B","\n\n * Male subjects aged between 18 and 45 years (inclusive) at screening who signed informed consent prior to any study-mandated procedure;\n * Healthy on the basis of physical examination, cardiac evaluations (12-lead ECG) and laboratory tests performed at screening;\n * Body mass index of 18 to 30 Kg/m2 (inclusive) at screening;\n * Systolic blood pressure 100-145 mmHg, diastolic blood pressure 50-90 mmHg, and pulse rate 50-90 beats per minute (inclusive).\n\nKey ","\n\n * Known allergic reactions or hypersensitivity to macitentan, riociguat, any drug of the same classes, or any of their excipients;\n * Any contraindication for riociguat treatment;\n * Known hypersensitivity or allergy to natural rubber latex;\n * Previous history of fainting, collapse, syncope, orthostatic hypotension, or vasovagal reactions;\n * History or clinical evidence of any disease and/or existence of any surgical or medical condition, which might interfere with the absorption, distribution, metabolism, or excretion of the study treatments;\n * Previous treatment with any prescribed medications (including vaccines) or over the counter (OTC) medications (including herbal medicines such as St John's Wort, homeopathic preparations, vitamins, and minerals) within 3 weeks prior to first study treatment administration;\n * Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.\n\nOther protocol defined inclusion and exclusion criteria may apply.",{"$nulls":4},"Actual","2018-01-03","Actual","Anticipated","2018-02-02","Anticipated","2018-01-01","2017-12-27","2017-12-27","2018-01-03","No","pharmacokinetics\nmacitentan\nriociguat","Interventional","Other","Single Group Assignment","None (Open Label)","N/A","18 Years","45 Years","Male",null,"Yes",{"$nulls":4},"No","No",{"$nulls":17},"2017-003502-41","EudraCT Number","Area under the plasma concentration-time curve (AUC) from zero to infinity [AUC(0-inf)] of riociguat|Maximum plasma concentration (Cmax) of riociguat","AUC(0-inf) of riociguat will be assessed following administration of riociguat alone or concomitantly with macitentan.|The maximum observed plasma concentration of riociguat will be assessed following administration of riociguat alone or concomitantly with macitentan.","Day 1 (pre-dose to 96 hours post-dose ), Day 10 (pre-dose to 144 hours post-dose)","Time to reach Cmax (tmax) of riociguat and its metabolite M1|Elimination half life (t1/2) of riociguat and its metabolite M1|AUC(0-t) of riociguat and its metabolite M1|AUC(0-inf) of riociguat metabolite M1|Maximum plasma concentration (Cmax) of riociguat metabolite M1|Trough concentration (Ctrough) of macitentan and its metabolite ACT-132577","The maximum observed time to reach Cmax of riociguat and M1 will be assessed following administration of riociguat alone or concomitantly with macitentan.|t1/2 of riociguat and M1 will be assessed following administration of riociguat alone or concomitantly with macitentan.|AUC(0-t) is the area under the plasma concentration-time curve from zero to time t of the last measured concentration above the limit of quantification. It will be determined for both riociguat and its metabolite M1 following administration of riociguat alone or concomitantly with macitentan.|AUC(0-inf) of M1 will be assessed following administration of riociguat alone or concomitantly with macitentan.|The maximum observed plasma concentration of M1 will be assessed following administration of riociguat alone or concomitantly with macitentan.|Ctrough of macitentan and its metabolite ACT-132577 will be assessed during the treatment period with macitentan (Day 10 to Day 15)","Day 1 (pre-dose to 96 hours post-dose ), Day 10 (pre-dose to 144 hours post-dose)|Day 10 to Day 15 (before macitentan administration) and in the morning of Day 16","clinical-trials-disclosure@actelion.com","CTD Clinical Trial Disclosure Desk","+41 61 565 6565",{"$nulls":7},"Shirin Bruderer, PhD","2018-01-03","2020-05-25T16:35:07.682","2020-05-26T17:10:42.972","NCT03389321"]
["5ecbf3bc11702c1b1b9169ab","NCT03389321","2018-01-09","Actelion","ALIOF","Recruiting","Clinical Study to Investigate Effect of Macitentan on Riociguat Pharmacokinetics","Riociguat|Macitentan","sGC Stimulant|ET Antagonist","No",null,"No",null,"Phase 1",1,20,"Anticipated","2017-12-20","2018-02-02","AUC","Area Under The Curve",{"$nulls":3},"Both macitentan and riociguat are indicated in the treatment of pulmonary arterial hypertension (PAH) and may be administered concomitantly. The primary objective of this study is to evaluate the effect of macitentan administered for 11 days on the pharmacokinetics (PK) (i.e., amount and time of presence in the blood of riociguat) of a single dose of riociguat in healthy male subjects.",null,"A Single-center, Open-label, One-sequence, Two-treatment Study to Investigate the Effect of Macitentan at Steady State on the Pharmacokinetics of Riociguat in Healthy Male Subjects","AC-055-123","Healthy Subjects","Healthy Volunteers","Healthy","Healthy","Experimental","Treatment A-B","All subjects will receive treatment A followed by treatment B. Treatment A consists of a single oral dose (1 mg) of riociguat (Adempas) on Day 1. Treatment B consists of a loading oral dose of 30 mg macitentan (Opsumit) (3 tablets of 10 mg) on Day 5, then 10 mg of macitentan once daily from Day 6 to Day 15, with a concomitant administration of riociguat (1 mg) on Day 10.","Drug","Riociguat (Adempas)|Macitentan (Opsumit)","Riociguat film-coated tablets for oral administration at a strength of 1 mg|Macitentan film-coated tablets for oral administration at a strength of 10 mg","ACT-064992","Treatment A-B","\n\n * Male subjects aged between 18 and 45 years (inclusive) at screening who signed informed consent prior to any study-mandated procedure;\n * Healthy on the basis of physical examination, cardiac evaluations (12-lead ECG) and laboratory tests performed at screening;\n * Body mass index of 18 to 30 Kg/m2 (inclusive) at screening;\n * Systolic blood pressure 100-145 mmHg, diastolic blood pressure 50-90 mmHg, and pulse rate 50-90 beats per minute (inclusive).\n\nKey ","\n\n * Known allergic reactions or hypersensitivity to macitentan, riociguat, any drug of the same classes, or any of their excipients;\n * Any contraindication for riociguat treatment;\n * Known hypersensitivity or allergy to natural rubber latex;\n * Previous history of fainting, collapse, syncope, orthostatic hypotension, or vasovagal reactions;\n * History or clinical evidence of any disease and/or existence of any surgical or medical condition, which might interfere with the absorption, distribution, metabolism, or excretion of the study treatments;\n * Previous treatment with any prescribed medications (including vaccines) or over the counter (OTC) medications (including herbal medicines such as St John's Wort, homeopathic preparations, vitamins, and minerals) within 3 weeks prior to first study treatment administration;\n * Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.\n\nOther protocol defined inclusion and exclusion criteria may apply.",{"$nulls":4},"Actual","2018-01-03","Actual","Anticipated","2018-02-02","Anticipated","2018-01-01","2017-12-27","2017-12-27","2018-01-08","No","pharmacokinetics\nmacitentan\nriociguat","Interventional","Other","Single Group Assignment","None (Open Label)","N/A","18 Years","45 Years","Male",null,"Yes",{"$nulls":4},"No","No",{"$nulls":17},"2017-003502-41","EudraCT Number","Area under the plasma concentration-time curve (AUC) from zero to infinity [AUC(0-inf)] of riociguat|Maximum plasma concentration (Cmax) of riociguat","AUC(0-inf) of riociguat will be assessed following administration of riociguat alone or concomitantly with macitentan.|The maximum observed plasma concentration of riociguat will be assessed following administration of riociguat alone or concomitantly with macitentan.","Day 1 (pre-dose to 96 hours post-dose ), Day 10 (pre-dose to 144 hours post-dose)","Time to reach Cmax (tmax) of riociguat and its metabolite M1|Elimination half life (t1/2) of riociguat and its metabolite M1|AUC(0-t) of riociguat and its metabolite M1|AUC(0-inf) of riociguat metabolite M1|Maximum plasma concentration (Cmax) of riociguat metabolite M1|Trough concentration (Ctrough) of macitentan and its metabolite ACT-132577","The maximum observed time to reach Cmax of riociguat and M1 will be assessed following administration of riociguat alone or concomitantly with macitentan.|t1/2 of riociguat and M1 will be assessed following administration of riociguat alone or concomitantly with macitentan.|AUC(0-t) is the area under the plasma concentration-time curve from zero to time t of the last measured concentration above the limit of quantification. It will be determined for both riociguat and its metabolite M1 following administration of riociguat alone or concomitantly with macitentan.|AUC(0-inf) of M1 will be assessed following administration of riociguat alone or concomitantly with macitentan.|The maximum observed plasma concentration of M1 will be assessed following administration of riociguat alone or concomitantly with macitentan.|Ctrough of macitentan and its metabolite ACT-132577 will be assessed during the treatment period with macitentan (Day 10 to Day 15)","Day 1 (pre-dose to 96 hours post-dose ), Day 10 (pre-dose to 144 hours post-dose)|Day 10 to Day 15 (before macitentan administration) and in the morning of Day 16","clinical-trials-disclosure@actelion.com","CTD Clinical Trial Disclosure Desk","+41 61 565 6565","Mannheim, Germany, 68167",null,"Germany","Crs Clinical Research Services Mannheim",{"$nulls":3},"Shirin Bruderer, PhD","2018-01-08","2020-05-25T16:35:08.354","2020-05-26T17:10:42.972","NCT03389321"]
["5ecbf3bbfeab101b155307c7","NCT03389321","2018-01-11","Actelion","ALIOF","Recruiting","Clinical Study to Investigate Effect of Macitentan on Riociguat Pharmacokinetics","Riociguat|Macitentan","sGC Stimulant|ET Antagonist","No",null,"No",null,"Phase 1",1,20,"Anticipated","2018-01-09","2018-02-02","AUC","Area Under The Curve",{"$nulls":3},"Both macitentan and riociguat are indicated in the treatment of pulmonary arterial hypertension (PAH) and may be administered concomitantly. The primary objective of this study is to evaluate the effect of macitentan administered for 11 days on the pharmacokinetics (PK) (i.e., amount and time of presence in the blood of riociguat) of a single dose of riociguat in healthy male subjects.",null,"A Single-center, Open-label, One-sequence, Two-treatment Study to Investigate the Effect of Macitentan at Steady State on the Pharmacokinetics of Riociguat in Healthy Male Subjects","AC-055-123","Healthy Subjects","Healthy Volunteers","Healthy","Healthy","Experimental","Treatment A-B","All subjects will receive treatment A followed by treatment B. Treatment A consists of a single oral dose (1 mg) of riociguat (Adempas) on Day 1. Treatment B consists of a loading oral dose of 30 mg macitentan (Opsumit) (3 tablets of 10 mg) on Day 5, then 10 mg of macitentan once daily from Day 6 to Day 15, with a concomitant administration of riociguat (1 mg) on Day 10.","Drug","Riociguat (Adempas)|Macitentan (Opsumit)","Riociguat film-coated tablets for oral administration at a strength of 1 mg|Macitentan film-coated tablets for oral administration at a strength of 10 mg","ACT-064992","Treatment A-B","\n\n * Male subjects aged between 18 and 45 years (inclusive) at screening who signed informed consent prior to any study-mandated procedure;\n * Healthy on the basis of physical examination, cardiac evaluations (12-lead ECG) and laboratory tests performed at screening;\n * Body mass index of 18 to 30 Kg/m2 (inclusive) at screening;\n * Systolic blood pressure 100-145 mmHg, diastolic blood pressure 50-90 mmHg, and pulse rate 50-90 beats per minute (inclusive).\n\nKey ","\n\n * Known allergic reactions or hypersensitivity to macitentan, riociguat, any drug of the same classes, or any of their excipients;\n * Any contraindication for riociguat treatment;\n * Known hypersensitivity or allergy to natural rubber latex;\n * Previous history of fainting, collapse, syncope, orthostatic hypotension, or vasovagal reactions;\n * History or clinical evidence of any disease and/or existence of any surgical or medical condition, which might interfere with the absorption, distribution, metabolism, or excretion of the study treatments;\n * Previous treatment with any prescribed medications (including vaccines) or over the counter (OTC) medications (including herbal medicines such as St John's Wort, homeopathic preparations, vitamins, and minerals) within 3 weeks prior to first study treatment administration;\n * Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.\n\nOther protocol defined inclusion and exclusion criteria may apply.",{"$nulls":4},"Actual","2018-01-03","Actual","Anticipated","2018-02-02","Anticipated","2018-01-01","2017-12-27","2017-12-27","2018-01-10","No","pharmacokinetics\nmacitentan\nriociguat","Interventional","Other","Single Group Assignment","None (Open Label)","N/A","18 Years","45 Years","Male",null,"Yes",{"$nulls":4},"No","No",{"$nulls":17},"2017-003502-41","EudraCT Number","Area under the plasma concentration-time curve (AUC) from zero to infinity [AUC(0-inf)] of riociguat|Maximum plasma concentration (Cmax) of riociguat","AUC(0-inf) of riociguat will be assessed following administration of riociguat alone or concomitantly with macitentan.|The maximum observed plasma concentration of riociguat will be assessed following administration of riociguat alone or concomitantly with macitentan.","Day 1 (pre-dose to 96 hours post-dose ), Day 10 (pre-dose to 144 hours post-dose)","Time to reach Cmax (tmax) of riociguat and its metabolite M1|Elimination half life (t1/2) of riociguat and its metabolite M1|AUC(0-t) of riociguat and its metabolite M1|AUC(0-inf) of riociguat metabolite M1|Maximum plasma concentration (Cmax) of riociguat metabolite M1|Trough concentration (Ctrough) of macitentan and its metabolite ACT-132577","The maximum observed time to reach Cmax of riociguat and M1 will be assessed following administration of riociguat alone or concomitantly with macitentan.|t1/2 of riociguat and M1 will be assessed following administration of riociguat alone or concomitantly with macitentan.|AUC(0-t) is the area under the plasma concentration-time curve from zero to time t of the last measured concentration above the limit of quantification. It will be determined for both riociguat and its metabolite M1 following administration of riociguat alone or concomitantly with macitentan.|AUC(0-inf) of M1 will be assessed following administration of riociguat alone or concomitantly with macitentan.|The maximum observed plasma concentration of M1 will be assessed following administration of riociguat alone or concomitantly with macitentan.|Ctrough of macitentan and its metabolite ACT-132577 will be assessed during the treatment period with macitentan (Day 10 to Day 15)","Day 1 (pre-dose to 96 hours post-dose ), Day 10 (pre-dose to 144 hours post-dose)|Day 10 to Day 15 (before macitentan administration) and in the morning of Day 16","clinical-trials-disclosure@actelion.com","CTD Clinical Trial Disclosure Desk","+41 61 565 6565","Mannheim, Germany, 68167",null,"Germany","Crs Clinical Research Services Mannheim",{"$nulls":3},"Shirin Bruderer, PhD","2018-01-10","2020-05-25T16:35:07.764","2020-05-26T17:10:42.972","NCT03389321"]
["5ecbf3bcfe30261b1a048197","NCT03389321","2018-02-08","Actelion","ALIOF","Completed","Clinical Study to Investigate Effect of Macitentan on Riociguat Pharmacokinetics","Riociguat|Macitentan","sGC Stimulant|ET Antagonist","No",null,"No",null,"Phase 1",1,20,"Actual","2018-01-09","2018-02-06","AUC","Area Under The Curve",{"$nulls":3},"Both macitentan and riociguat are indicated in the treatment of pulmonary arterial hypertension (PAH) and may be administered concomitantly. The primary objective of this study is to evaluate the effect of macitentan administered for 11 days on the pharmacokinetics (PK) (i.e., amount and time of presence in the blood of riociguat) of a single dose of riociguat in healthy male subjects.",null,"A Single-center, Open-label, One-sequence, Two-treatment Study to Investigate the Effect of Macitentan at Steady State on the Pharmacokinetics of Riociguat in Healthy Male Subjects","AC-055-123","Healthy Subjects","Healthy Volunteers","Healthy","Healthy","Experimental","Treatment A-B","All subjects will receive treatment A followed by treatment B. Treatment A consists of a single oral dose (1 mg) of riociguat (Adempas) on Day 1. Treatment B consists of a loading oral dose of 30 mg macitentan (Opsumit) (3 tablets of 10 mg) on Day 5, then 10 mg of macitentan once daily from Day 6 to Day 15, with a concomitant administration of riociguat (1 mg) on Day 10.","Drug","Riociguat (Adempas)|Macitentan (Opsumit)","Riociguat film-coated tablets for oral administration at a strength of 1 mg|Macitentan film-coated tablets for oral administration at a strength of 10 mg","ACT-064992","Treatment A-B","\n\n * Male subjects aged between 18 and 45 years (inclusive) at screening who signed informed consent prior to any study-mandated procedure;\n * Healthy on the basis of physical examination, cardiac evaluations (12-lead ECG) and laboratory tests performed at screening;\n * Body mass index of 18 to 30 Kg/m2 (inclusive) at screening;\n * Systolic blood pressure 100-145 mmHg, diastolic blood pressure 50-90 mmHg, and pulse rate 50-90 beats per minute (inclusive).\n\nKey ","\n\n * Known allergic reactions or hypersensitivity to macitentan, riociguat, any drug of the same classes, or any of their excipients;\n * Any contraindication for riociguat treatment;\n * Known hypersensitivity or allergy to natural rubber latex;\n * Previous history of fainting, collapse, syncope, orthostatic hypotension, or vasovagal reactions;\n * History or clinical evidence of any disease and/or existence of any surgical or medical condition, which might interfere with the absorption, distribution, metabolism, or excretion of the study treatments;\n * Previous treatment with any prescribed medications (including vaccines) or over the counter (OTC) medications (including herbal medicines such as St John's Wort, homeopathic preparations, vitamins, and minerals) within 3 weeks prior to first study treatment administration;\n * Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.\n\nOther protocol defined inclusion and exclusion criteria may apply.",{"$nulls":4},"Actual","2018-01-03","Actual","Actual","2018-02-06","Actual","2018-02-01","2017-12-27","2017-12-27","2018-02-07","No","pharmacokinetics\nmacitentan\nriociguat","Interventional","Other","Single Group Assignment","None (Open Label)","N/A","18 Years","45 Years","Male",null,"Yes",{"$nulls":4},"No","No",{"$nulls":17},"2017-003502-41","EudraCT Number","Area under the plasma concentration-time curve (AUC) from zero to infinity [AUC(0-inf)] of riociguat|Maximum plasma concentration (Cmax) of riociguat","AUC(0-inf) of riociguat will be assessed following administration of riociguat alone or concomitantly with macitentan.|The maximum observed plasma concentration of riociguat will be assessed following administration of riociguat alone or concomitantly with macitentan.","Day 1 (pre-dose to 96 hours post-dose ), Day 10 (pre-dose to 144 hours post-dose)","Time to reach Cmax (tmax) of riociguat and its metabolite M1|Elimination half life (t1/2) of riociguat and its metabolite M1|AUC(0-t) of riociguat and its metabolite M1|AUC(0-inf) of riociguat metabolite M1|Maximum plasma concentration (Cmax) of riociguat metabolite M1|Trough concentration (Ctrough) of macitentan and its metabolite ACT-132577","The maximum observed time to reach Cmax of riociguat and M1 will be assessed following administration of riociguat alone or concomitantly with macitentan.|t1/2 of riociguat and M1 will be assessed following administration of riociguat alone or concomitantly with macitentan.|AUC(0-t) is the area under the plasma concentration-time curve from zero to time t of the last measured concentration above the limit of quantification. It will be determined for both riociguat and its metabolite M1 following administration of riociguat alone or concomitantly with macitentan.|AUC(0-inf) of M1 will be assessed following administration of riociguat alone or concomitantly with macitentan.|The maximum observed plasma concentration of M1 will be assessed following administration of riociguat alone or concomitantly with macitentan.|Ctrough of macitentan and its metabolite ACT-132577 will be assessed during the treatment period with macitentan (Day 10 to Day 15)","Day 1 (pre-dose to 96 hours post-dose ), Day 10 (pre-dose to 144 hours post-dose)|Day 10 to Day 15 (before macitentan administration) and in the morning of Day 16",{"$nulls":3},"Mannheim, Germany, 68167",null,"Germany","Crs Clinical Research Services Mannheim",{"$nulls":3},"Shirin Bruderer, PhD","2018-02-07","2020-05-25T16:35:08.056","2020-05-26T17:10:42.972","NCT03389321"]
["5ecbf3bce2561b1b11905c93","NCT03390036","2018-01-04","Anika Therapeutics","ANIK","Enrolling by invitation","Study of Cingalâ„¢ for the Relief of Knee Osteoarthritis Compared to Triamcinolone Hexacetonide at 39 Weeks Follow up (Cingal17-02)","Hyaluronic acid|Triamcinolone hexacetonide","GR Agonist","Yes","['Hyaluronic acid']","Unknown",null,"Phase 3",3,576,"Anticipated","2017-12-07","2018-07-01",{"$nulls":5},"The objective of this sub-study is to evaluate the efficacy and safety at 39 week follow up of a single injection of Cingal for relief of joint pain in subjects with OA of the knee who have not responded to conservative treatment (weight reduction, physical therapy, pain medications, etc.).",null,"Extension Study to Cingal 16-02: Trial Extension to 39 Week Follow Up in the Randomized, Double-Blind, Active Comparator Controlled, Multi-Center Study of a Single Injection Cross-Linked Sodium Hyaluronate Combined With Triamcinolone Hexacetonide (CingalÂ®) to Provide Symptomatic Relief of Osteoarthritis of the Knee","Cingal 17-02","Osteo Arthritis Knee","Arthritis","Joint Diseases","Musculoskeletal","Experimental|Active Comparator","Cingal|Monovisc|Triamcinolone Hexacetonide (TH)","A chemically cross-linked sodium hyaluronate supplied as a 4-mL unit dose with a nominal 18 mg of triamcinolone hexacetonide (TH).|A chemically cross-linked sodium hyaluronate supplied as a 4-mL unit dose|A 1 mL unit dose of Triamcinolone Hexacetonide (TH) supplied as 20 mg/ml.","Drug|Device","Cingal|Monovisc|Triamcinolone Hexacetonide","A chemically cross-linked sodium hyaluronate supplied as a 4-mL unit dose with a nominal 18 mg of triamcinolone hexacetonide (TH)|A chemically cross-linked sodium hyaluronate supplied as a 4-mL unit dose|20 mg/ml supplied as 1 mL unit dose of Triamcinolone Hexacetonide","TH","Cingal|Monovisc|Triamcinolone Hexacetonide (TH)","\n\n 1. Subjects meet the inclusion criteria for Cingal 16-02 and signed the informed consent.\n 2. Subject is able to understand and comply with the requirements of Cingal 17-02 and voluntarily provides consent.\n\n","\n\nPatients will not be rescreened at enrollment to Cingal 17-02 as these patients met the inclusion / exclusion criteria for the Cingal 16-02 clinical trial.",{"$nulls":4},"Actual","2018-01-04","Actual","Anticipated","2018-07-01","Anticipated","2017-12-01","2017-12-28","2017-12-28","2017-12-28","Yes",null,"Interventional","Treatment","Parallel Assignment","Double (Participant, Outcomes Assessor)","Randomized","40 Years","75 Years","All",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":4},"Yes",{"$nulls":14},"OMERACT-OARSI Responder Rate","Outcomes Measures for Rheumatic Arthritis Clinical Trials-Osteoarthritis Research Society International","39 weeks",{"$nulls":6},"Budapest, Hungary, 1051",null,"Hungary","Health Center Of Downtown-Lipotvaros, Orthopedic Outpatient Clinic (BelvÃ¡rosi-LipÃ³tvÃ¡rosi EgÃ©szsÃ©gÃ¼gyi SzolgÃ¡lat Ortopeadia)",{"$nulls":4},"2017-12-28","2020-05-25T16:35:08.656","2020-05-26T17:10:42.972","NCT03390036"]
["5ecbf3bcfeab101b155307c8","NCT03390036","2018-09-18","Anika Therapeutics","ANIK","Completed","Study of Cingalâ„¢ for the Relief of Knee Osteoarthritis Compared to Triamcinolone Hexacetonide at 39 Weeks Follow up (Cingal17-02)","Hyaluronic acid|Triamcinolone hexacetonide","GR Agonist","Yes","['Hyaluronic acid']","Unknown",null,"Phase 3",3,526,"Actual","2017-12-07","2018-07-30",{"$nulls":5},"The objective of this sub-study is to evaluate the efficacy and safety at 39 week follow up of a single injection of Cingal for relief of joint pain in subjects with OA of the knee who have not responded to conservative treatment (weight reduction, physical therapy, pain medications, etc.).",null,"Extension Study to Cingal 16-02: Trial Extension to 39 Week Follow Up in the Randomized, Double-Blind, Active Comparator Controlled, Multi-Center Study of a Single Injection Cross-Linked Sodium Hyaluronate Combined With Triamcinolone Hexacetonide (CingalÂ®) to Provide Symptomatic Relief of Osteoarthritis of the Knee","Cingal 17-02","Osteo Arthritis Knee","Arthritis","Joint Diseases","Musculoskeletal","Experimental|Active Comparator","Cingal|Monovisc|Triamcinolone Hexacetonide (TH)","A chemically cross-linked sodium hyaluronate supplied as a 4-mL unit dose with a nominal 18 mg of triamcinolone hexacetonide (TH).|A chemically cross-linked sodium hyaluronate supplied as a 4-mL unit dose|A 1 mL unit dose of Triamcinolone Hexacetonide (TH) supplied as 20 mg/ml.","Drug|Device","Cingal|Monovisc|Triamcinolone Hexacetonide","A chemically cross-linked sodium hyaluronate supplied as a 4-mL unit dose with a nominal 18 mg of triamcinolone hexacetonide (TH)|A chemically cross-linked sodium hyaluronate supplied as a 4-mL unit dose|20 mg/ml supplied as 1 mL unit dose of Triamcinolone Hexacetonide","TH","Cingal|Monovisc|Triamcinolone Hexacetonide (TH)","\n\n 1. Only subjects that were enrolled and met the inclusion criteria for the Cingal 16-02 trial and signed the informed consent are eligible for Cingal 17-02 trial.\n 2. Subject is able to understand and comply with the requirements of Cingal 17-02 and voluntarily provides consent.\n\n","\n\nPatients will not be rescreened at enrollment to Cingal 17-02 as these patients met the inclusion / exclusion criteria for the Cingal 16-02 clinical trial.",{"$nulls":4},"Actual","2018-01-04","Actual","Actual","2018-07-30","Actual","2018-09-01","2017-12-28","2017-12-28","2018-09-14","Yes",null,"Interventional","Treatment","Parallel Assignment","Double (Participant, Outcomes Assessor)","Randomized","40 Years","75 Years","All",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":4},"Yes",{"$nulls":14},"OMERACT-OARSI Responder Rate","Outcomes Measures for Rheumatic Arthritis Clinical Trials-Osteoarthritis Research Society International","39 weeks",{"$nulls":6},"Budapest, Hungary, 1051 Uzsoki Hospital, Department Of TraumatologyBudapest, Hungary, 1145 Jutrix Medical LlcBudapest, Hungary, 6000 Magyar Honvedseg, Egeszseugyi Kozpont, Balesteti Sebeszeti OsztalyBudapest, Hungary De Kk Ortopediai KlinikaDebrecen, Hungary Medidea Bt.Kiskunfelegyhaza, Hungary Kastelypark KlinkaTata, Hungary|BiaÅ‚ystok, Poland Szpital ÅšwiÄ™tego Å\u0081ukasza S.A.Bielsko-BiaÅ‚a, Poland Nzoz Medi SpatxGilwice, Poland Centrum Medyczne 4M PlusKrakÃ³w, Poland Novamed Jackowiak Krajewski SpÃ³Å‚ka JawnaToruÅ„, Poland Centrum Medyczne Amed Warszawa TargÃ³wekWarsaw, Poland Etg Network, WarsawWarsaw, Poland Etg NetworkWarsaw, Poland Medical University Of LodzÅ\u0081Ã³dÅº, Poland Lubelskie Centrum DiagnostyczneÅšwidnik,, Poland",null,"Hungary|Poland","Health Center Of Downtown-Lipotvaros, Orthopedic Outpatient Clinic (BelvÃ¡rosi-LipÃ³tvÃ¡rosi EgÃ©szsÃ©gÃ¼gyi SzolgÃ¡lat Ortopeadia)|Zdrowie Osteo-Medic",{"$nulls":4},"2018-09-14","2020-05-25T16:35:08.671","2020-05-26T17:10:42.972","NCT03390036"]
["5ecbf3bf11702c1b1b9169af","NCT03390504","2018-01-30","Johnson & Johnson","JNJ","Not yet recruiting","A Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Participants With Advanced Urothelial Cancer and Selected Fibroblast Growth Factor Receptor (FGFR) Gene Aberrations","Erdafitinib|Fibroblast|Vinflunine|Docetaxel|Pembrolizumab","FGFR Antagonist|Tubulin Inhibitor|Mitosis Inhibitor|Tubulin Inhibitor|PD-1 Inhibitor","Yes","['Erdafitinib', 'Fibroblast', 'Vinflunine']","No",null,"Phase 3",4,630,"Anticipated","2018-01-31","2020-11-24","OS","Overall Survival",{"$nulls":3},"The purpose of this study is to evaluate efficacy of erdafitinib versus chemotherapy or pembrolizumab in participants with advanced urothelial cancer harboring selected fibroblast growth factor receptor (FGFR) aberrations who have progressed after one prior treatment.","A study of erdafitinib versus standard of care, consisting of chemotherapy (docetaxel or vinflunine) or PD1 agent pembrolizumab, in participants with advanced urothelial cancer and selected FGFR aberrations who have progressed on or after one prior line of systemic therapy. It will consist of screening, treatment phase (from randomization until disease progression, intolerable toxicity, withdrawal of consent or decision by investigator to discontinue treatment else participants will discontinue treatment after completion of 2 years pembrolizumab therapy), post-treatment follow-up (from end-of-treatment to participants death, withdraws consent, lost to follow-up, or end of study, whichever comes first). Efficacy, pharmacokinetics, biomarkers, patient reported outcomes, medical resource utilization and safety will be assessed.","A Phase 3 Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Subjects With Advanced Urothelial Cancer and Selected FGFR Gene Aberrations","CR108401","Urothelial Cancer","Transitional Cell Carcinoma","Oncology Solid Tumor","Oncology","Experimental","Cohort 1 (Arm 1A): Erdafitinib|Cohort 1 (Arm 1B): Vinflunine or Docetaxel|Cohort 2 (Arm 2A): Erdafitinib|Cohort 2 (Arm 2B): Pembrolizumab","Participants will be screened based on Fibroblast Growth Factor Receptor inhibitor Clinical Trial Assay (FGFRi CTA) to determine molecular eligibility and participants who meet molecular eligibility criteria will be enrolled. Participants (treated with prior anti-anti-programmed cell death protein [PD][L]1 agent) will swallow erdafitinib tablets orally at a starting dose of 8 milligram (mg), once daily for 21 days in a 21-day cycle until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustment are based on phosphate level and observed toxicity (adverse events [AEs]).|Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be enrolled. Participants (treated with prior anti-PD[L]1 agent) will receive vinflunine 320 milligram per meter square (mg/m^2) as a 20-minute intravenous infusion once every 3 weeks or docetaxel 75 mg/m^2 as a 1 hour intravenous infusion every 3 weeks. Treatment with either agent (choice of investigator) will be administered until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustments are based on observed toxicities.|Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be enrolled. Participants (no prior treatment with anti-PD(L)1 agent) will swallow erdafitinib tablets orally at a starting dose of 8 mg, once daily for 21 days in a 21-day cycle until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustments are based on phosphate level and observed toxicity (AEs).|Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be enrolled. Participants (no prior treatment with anti-PD(L)1 agent) will receive pembrolizumab 200 mg as a 30-minute intravenous infusion once every 3 weeks, until disease progression, intolerable toxicity, withdrawal of consent, decision by the investigator to discontinue treatment or the completion of 2 years of pembrolizumab therapy. Dose adjustments are based on observed toxicities.","Drug|Device","Erdafitinib|Fibroblast Growth Factor Receptor inhibitor Clinical Trial Assay (FGFRi CTA)|Vinflunine|Docetaxel|Pembrolizumab","Participants will swallow erdafitinib tablets orally at a starting dose of 8 mg.|FGFRi CTA will be used to determine molecular eligibility.|Participants will receive vinflunine 320 mg/m^2 as a 20-minute intravenous infusion.|Participants will receive docetaxel 75 mg/m^2 as a 1 hour intravenous infusion.|Participants will receive pembrolizumab 200 mg as a 30-minute intravenous infusion.","JNJ-42756493","Cohort 1 (Arm 1A): Erdafitinib|Cohort 1 (Arm 1B): Vinflunine or Docetaxel|Cohort 2 (Arm 2A): Erdafitinib|Cohort 2 (Arm 2B): Pembrolizumab","\n\n * Histologic demonstration of transitional cell carcinoma of the urothelium. Minor components ( less than [<] 50 percent [%] overall) of variant histology such as glandular or squamous differentiation, or evolution to more aggressive phenotypes such as sarcomatoid or micropapillary change are acceptable\n * Stage IV disease (metastatic or surgically unresectable, cT4b, N+, or M+ cancer)\n * Documented progression of disease, defined as any progression that requires a change in treatment, prior to randomization\n * Only one line of prior systemic treatment for metastatic urothelial cancer. Participants who received neoadjuvant or adjuvant chemotherapy and showed disease progression (as defined above), within 12 months of the last dose are considered to have received systemic chemotherapy in the metastatic setting Cohort 1: prior chemotherapy and anti-PD(L)1 [in combination or in maintenance setting] (anti-PD(L)1 alone is allowed only for participants with documented cisplatin ineligibility) and Cohort 2: prior chemotherapy (no prior anti-PD(L)1 treatment)\n * A woman of childbearing potential who is sexually active must have a negative pregnancy test (beta human chorionic gonadotropin [beta hCG]) at Screening (urine or serum)\n * Participants must meet appropriate molecular eligibility criteria\n * Eastern Cooperative Oncology Group (ECOG) performance status Grade 0, 1, or 2\n * Adequate bone marrow, liver, and renal function\n\n","\n\n * Treatment with any other investigational agent or participation in another clinical study with therapeutic intent within 30 days prior to randomization\n * Active malignancies (that is, requiring treatment change in the last 24 months) other than urothelial cancer (except skin cancers within the last 24 months that is considered completely cured)\n * Symptomatic central nervous system metastases\n * Received prior fibroblast growth factor receptor (FGFR) inhibitor treatment\n * Known allergies, hypersensitivity, or intolerance to erdafitinib or its excipients\n * Corneal or retinal abnormality likely to increase the risk of eye toxicity\n * History of uncontrolled cardiovascular disease including\n * Impaired wound healing capacity defined as skin/decubitus ulcers, chronic leg ulcers, known gastric ulcers, or unhealed incisions",{"$nulls":4},"Actual","2018-01-04","Actual","Anticipated","2021-12-31","Anticipated","2018-01-01","2017-12-20","2018-01-03","2018-01-29","Yes",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","Yes",{"$nulls":17},"2017-002932-18|42756493BLC3001","EudraCT Number|Janssen Research & Development, LLC","Overall Survival (OS)","Overall survival is measured from the date of randomization to the date of the participant's death. If the participant is alive or the vital status is unknown, the participant will be censored at the date the participant was last known to be alive.","Date of first randomization to the date of participant's death (approximately up to 3 years)","Progression-free Survival (PFS)|Overall Response Rate (ORR)|Time to Worsening in Symptom Items and Functioning Subscales in Patient-Reported Health Status of the Functional Assessment of Cancer Therapy-Bladder Cancer (FACT-Bl)|Change from Baseline in Patient-Global Impression of Severity (PGIS) Score|Change from Baseline in the Visual Analog Scale (VAS) of the EQ-5D-5L|Change from Baseline in the Utility Scale of the EQ-5D-5L|Duration of Response (DOR)|Number of Participants with Adverse Events (AEs) as a Measure of Safety|Oral Clearance (CL/F) of Erdafitinib|Area Under the Plasma Concentration-Time Curve from Time Zero to Time 't' (AUC[0-t]) of Erdafitinib","PFS is defined as duration in days from date of randomization to disease progression date (assessed per Response Evaluation Criteria in Solid Tumors Version 1.1|ORR is defined as the proportion of participants who achieve CR (CR; disappearance of all target lesions and disappearance of all non-target lesions and normalization of tumor marker level) or partial response (PR; at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters), as assessed per RECIST v1.1 by the investigator.|The FACT-Bl consists of 36 core items, with 5-point Likert response scales, covering 5 primary domains: Physical well-being, social/family well-being, emotional well-being, functional well-being and bladder symptom subscale. The answer scales range from \"Not at all (score=0)\" to \"very much (score=4)\" to assess the meaningful significant symptom deterioration.|The PGIS is a single question regarding the participant report of disease severity. Participants will be asked that ''considering all aspects of your bladder cancer symptoms right now, would you say your bladder cancer symptoms are none, mild, moderate, severe, or very severe?\" The PGIS is an anchor question that will be used to establish the magnitude of meaningful change in this study by assessing disease severity.|European Quality of Life 5 Dimensions (EQ-5D) visual analog scale (VAS) is a 20 centimeter (cm) vertical VAS with scores ranging from 0 (worst imaginable health) to 100 (perfect health). A higher score indicates an improvement in health in the Health Status Index.|The EuroQol-5 is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating \"full health\" and 0 representing dead.|DOR for responders is defined as duration in days from the date of initial documentation of a response to the date of first documented evidence of progressive disease (PD) or relapse for participants who experience CR (CR; disappearance of all target lesions and disappearance of all non-target lesions and normalization of tumor marker level) during the study or death.|An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.|CL/F is the oral clearance; that is clearance based on oral bioavailability of erdafitinib.|AUC(0-t) is the area under the plasma concentration-time curve from time zero to any time 't' of erdafitinib.","RECIST v1.1 by investigator) or relapse from CR or death, whichever is reported first. RECIST 1.1, progressive disease is defined as a 20 percent (%) increase in the sum of diameters of all target lesions and a minimum absolute increase of 5 millimeter (mm) in the sum. CR is defined as disappearance of all target lesions, non-target lesions and normalization of tumor marker level.|Approximately up to 3 years|Baseline up to end of treatment (approximately 3 years)|Baseline up to follow up phase (approximately 3 years)|From the date of initial documentation of a response to date of first documented evidence of progressive disease (or participants relapse who experience CR during the study) or death (approximately up to 3 years)|Day 14 (Cycle 1), Day 1 (Cycle 2) (each cycle is of 21 days)","JNJ.CT@sylogent.com","Study Contact","844-434-4210","Camperdown, Australia, 2050 Peninsula & South Eastern Haematology And Oncology GroupFrankston, Australia, 3199 Frankston HospitalMelbourne, Australia, 3199|Graz, Austria, 8036 Krankenhaus Der Barmherzigen SchwesternLinz, Austria, 4010 Medical University Vienna, MuvVienna, Austria, A-1090|Aalst, Belgium, 9300 Zna MiddelheimAntwerpen, Belgium, 2020 Cliniques Universitaires Saint-LucBrussel, Belgium, 1200 Clinique Notre Dame De GrÃ¢ceCharleroi, Belgium, 6000 Az Maria MiddelaresGent, Belgium, 9000 Universitair Ziekenhuis GentGent, Belgium, 9000 Sint-Augustinus AzWilrijk, Belgium, 2610|Barretos, Brazil, 14784-400 AssociaÃ§Ã£o MÃ¡rio Penna\\NÃºcleo De Ensino E PesquisasBelo Horizonte, Brazil, 30380-472 Hospital Erasto GaertnerCuritiba, Brazil, 81520-060 ClÃ­nica De Neoplasias Litoral Ltda.Itajai, Brazil, 88301-220 Upco - HcpaPorto Alegre, Brazil, 90035-903 Inca - Instituto Nacional Do CancerRio De Janeiro, Brazil, 20231-050 Fundacao Antonio PrudenteSao Paulo, Brazil, 01509900 Hospital De Base De SÃ£o JosÃ© Do Rio PretoSÃ£o JosÃ© Do Rio Preto, Brazil, 15090-000 Cepho - Faculdade De Medicina Do AbcSÃ£o Paulo, Brazil, 09060-650|Vancouver, British Columbia, Canada, V5Z 4E6|Beijing, China, 100034 Beijing Cancer HospitalBeijing, China, 100142 Peking University Third HospitalBeijing, China, 100191 Jiangsu Cancer HospitalNanjing, China, 210009|Angers, France, 49055 Hopital Jean MinjozBesancon Cedex, France, 25030 Institut BergoniÃ©Bordeaux, France, 33000 Hopital Henri MondorCreteil, France, 94010 Centre Georges-FranÃ§ois LeclercDijon, France, 21079 Centre Oscar LambretLille, France, 59020 Centre Leon BÃ©rardLyon, France, 69008 Hopital De La TimoneMarseille, France, 13005 Institut Regional Du Cancer De Montpellier Val D'AurelleMontpellier, France, 34298 Centre Antoine LacassagneNice, France, 06189 Institut De CancÃ©rologie Du GardNÃ®mes, France, 30029 Hopital Europeen Georges-PompidouParis, France, 75015 Hospices Civils De Lyon HclPierre-BÃ©nite, France, 69495 Chu De PoitiersPoitiers Cedex, France, 86021 Centre Hopitalier Inter-Communal De CornouailleQuimper, France, 2900 I.C.O. RenÃ© GauducheauSaint Herblain Cedex, France, 44805 Institut De CancÃ©rologie De LoireSaint-Priest-En-Jarez, France, 42271 Hopitaux Universitaires De StrasbourgStrasbourg, France, 67091 Institut Claudius RegaudToulouse, France, 31059 Institut Gustave RoussyVillejuif, France, 94805|Berlin, Germany, 10967 Universitatsklinikum Carl Gustav Carcus DresdenDresden, Germany, 01307 Universitaetsklinikum DuesseldorfDuesseldorf, Germany, 40225 Friedrich-Alexander Universitaet Urologische UniversitaetsklErlangen, Germany, 91054 Universitatsklinikum FreiburgFreiburg, Germany, 79106 UniversitÃ¤tsmedizin GreifswaldGreifswald, Germany, 17475 UniversitÃ¤tsmedizin GÃ¶ttingenGÃ¶ttingen, Germany, 37099 Asklepios Klinik AltonaHamburg, Germany, 22763 Medizinische Hochschule HannoverHannover, Germany, 30625 Universitaetsklinikum MuensterMuenster, Germany, 48149 Studienpraxis Urologie Drs. FeyerabendNuertingen, Germany, 72622 Kliniken Nordoberpfalz Ag/Klinikum WeidenWeiden, Germany, 92637|AchaÃ¯a, Greece, 26504 University Of Athens Medical School - Regional General HospiAthina, Greece, 115 28 University Hospital Of HeraklionHeraklion, Greece, 71110 University Hospital Of LarissaLarisa, Greece, 41110 Interbalkan European Medical CenterThessaloniki, Greece, 14564|Budapest, Hungary, 1082 Orszagos Onkologiai IntezetBudapest, Hungary, 1122 Uzsoki Utcai KorhazBudapest, Hungary, H-1145 Szabolcs-Szatmar-Bereg Megyei Korhazak Es Egyetemi OktatokorhazNyÃ­regyhÃ¡za, Hungary, 04400 Pecsi TudomanyegyetemPÃ©cs, Hungary, 7624|Pune, India, 411001|Haifa, Israel, 31096 Hadassah Medical CenterJerusalem, Israel, 91120 Yitzhak Shamir Medical CenterZerifin, Israel, 70300|Arezzo, Italy, 52100 Cro, Irccs, Istituto Nazionale TumoriAviano, Italy, 33081 Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia Presidio Spedali CiviliBrescia, Italy, 25123 Istituti Ospitalieri Di Cremona, Ao Di CremonaCremona, Italy, 26100 Policlinico Hospital San Martino- Irccs For OncologyGenova, Italy, 16132 Irst Meldola - ForlÃ¬Meldola, Italy, 47014 Aou Policlinico Di ModenaModena, Italy, 41124 Ospedale Maggiore Della CaritÃ Novara, Italy, 28100 Aou San Luigi GonzagaOrbassano, Italy, 10043 Istituto Oncologico Veneto Iov Irccs PadovaPadova, Italy, 35128 Aou Di ParmaParma, Italy, 43126 Irccs Policlinico San MatteoPavia, Italy, 27100 Azienda Ospedaliero Universitaria PisanaPisa, Italy, 56126 Oncologia Medica-CittÃ  Della Salute E Della Scienza Di TorinoTorino, Italy, 10123 Azienda Ospedaliero - Universitaria Ospedali RiunitiTorrette Di Ancona, Italy, 60126|Kashiwa, Japan, 277-8577 Kagawa University HospitalKita-Gun, Japan, 761-0793 Dokkyo Medical University Koshigaya HospitalKoshigaya, Japan, 343-8555 National Shikoku Cancer CenterMatsuyama, Japan, 791-0280 Aichi Cancer Center HospitalNagoya-Shi, Japan, 464-8681 Toho University Sakura Medical CenterSakura, Japan, 285-8741 National Hospital, Hokkaido Cancer CenterSapporo, Japan, 003-0804 University Of Tsukuba HospitalTsukuba, Japan, 305-8576 Yokohama City University Medical CenterYokohama, Japan, 232-0024 Korea, Republic Of Pusan National University Hospital.Busan, Korea, Republic Of, 49241 Chungnam National University HospitalDaejeon, Korea, Republic Of, 35015 National Cancer CenterGoyangsi, Korea, Republic Of, 410-769 Gachon University Gil Medical CenterIncheon, Korea, Republic Of, 21565 Seoul National University Bundang HospitalSeongnam, Korea, Republic Of, 463-707 Seoul National University HospitalSeoul, Korea, Republic Of, 03080 Severance Hospital, Yonsei University Health SystemSeoul, Korea, Republic Of, 03722 Samsung Medical CenterSeoul, Korea, Republic Of, 135-710|Aguascalientes, Mexico, 20230|Lisboa, Portugal, 1500-458 H. Santa Maria - Centro Hospitalar De Lisboa NorteLisboa, Portugal, 1649-035 Hospital Santo Antonio Dos CapuchosLisboa, Portugal, G1R 2J6 Champalimaud Foundation Champalimaud CentreLisbon, Portugal, 1400-038 Instituto Portugues De OncologiaPorto, Portugal, 4200072 Russian Federation Altai Regional Oncology DispensaryBarnaul, Russian Federation, 656049 Chelyabinsk Regional Clinical Center Of Oncology And Nuclear MedicineChelyabinsk, Russian Federation, 454087 Ivanovo Regional Oncology DispensaryIvanovo, Russian Federation, 153040 Fsbsi 'N. N. Blokhin Russian Cancer Research Center'Moscow, Russian Federation, 115478 Russian Scientific Center Of RoentgenoradiologyMoscow, Russian Federation, 117997 Hertzen Oncology Research InstituteMoscow, Russian Federation, 125284 Privolzhsky District Medical Center Under The Federal Medico-Biological AgencyNizhni Novgorod, Russian Federation, 603109 National Medical Radiological Research CenterObninsk, Russian Federation, 249036 Clinical Oncology DispensaryOmsk, Russian Federation, 644013 Gbuz Of Stavropol Region Pyatigorsk Oncological DispensaryPyatigorsk, Russian Federation, 357502 City Polyprofiled Hospital #2Saint Petersburg, Russian Federation, 194354 Pavlov First Saint Petersburg State Medical UniversitySaint Petersburg, Russian Federation, 197022 Clinical Hopital N/A Petra VelikogoSaint-Petersburg, Russian Federation, 195067 National Research Mordovia State UniversitySaransk, Russian Federation, 430032 Russian Scientific Center Of Radiology And Surgical TechnologiesSt. Petersburg, Russian Federation, 197758 Northen-Western State Medical University N.A. I.I. MechnikovSt.Petersburg, Russian Federation, 191015 Llc BioeqSt.Petersburg, Russian Federation, 197342 Multifunctional Clinical Medical Center 'Medical City'Tyumen, Russian Federation, 625041|Badajoz, Spain, 06006 Institut CatalÃ  D'Oncologia-Hospital Universitari Germans Trias I PujolBadalona, Spain, 08916 Hosp. Clinic I Provincial De BarcelonaBarcelona, Spain, 08036 Hosp. De La Santa Creu I Sant PauBarcelona, Spain, 08041 Hosp. Reina SofiaCÃ³rdoba, Spain, 14004 Complejo Hospitalario De JaenJaÃ©n, Spain, 23007 Hosp. Univ. Lucus AugustiLugo, Spain, 27003 Centro Oncologico Md AndersonMadrid, Spain, 28033 Hosp. Univ. La PazMadrid, Spain, 28046 Hosp. Univ. Pta. De Hierro MajadahondaMajadahonda, Spain, 28220 Althaia, Xarxa Assistencial UniversitÃ ria De ManresaManresa, Spain, 08243 Hosp. Virgen De La VictoriaMÃ¡laga, Spain, 29010 Hosp. De NavarraPamplona, Spain, 31008 Hosp. Virgen MacarenaSevilla, Spain, 41009 Hosp. Virgen Del RocioSevilla, Spain, 41013 Hosp. Univ. I Politecni La FeValencia, Spain, 46026 Hosp. Univ. Miguel ServetZaragoza, Spain, 50009 Taiwan Kaohsiung Medical University Chung-Ho Memorial HospitalKaohsiung, Taiwan, 807 Chi Mei Medical Center - Liu YingLiou Ying Township, Taiwan, 736 Chang Gung Medical FoundationNiao-Sung Hsiang, Taiwan, 833 National Cheng Kung University HospitalTainan, Taiwan, 70403 National Taiwan University HospitalTaipei City, Taiwan, 10002 Mackay Memorial HospitalTaipei, Taiwan, 10449 Taipei Veterans General HospitalTaipei, Taiwan, 11217 Koo Foundation Sun Yat-Sen Cancer CenterTaipei, Taiwan, 11259|Adana, Turkey, 01120 Hacettepe University Medical FacultyAnkara, Turkey, 6100 Bezmialem University Medical FacultyIstanbul, Turkey, 34093 Medipol Mega University HospitalIstanbul, Turkey, 34214 Marmara University Medical FacultyIstanbul, Turkey, 34890 Istanbul Medeniyet University Goztepe Training And Research HospitalIstanbul, Turkey, 81450 Ege UniversityIzmir, Turkey, 35100 Kocaeli University Medical FacultyKocaeli, Turkey Inonu Universitesi Turgut Ozal Tip Merkezi, Ic HastaliklariMalatya, Turkey, 44400|Chernivtsi, Ukraine, 58002 Mi Dnipropetrovsk Region Clinical Hospital N A I.I.MechnikovDnipropetrovsk, Ukraine, 49005 Komunalnyi Zaklad Miska Bahatoprofilna Klinichna Likarnia #4Dnipropetrovsk, Ukraine, 49102 Regional Oncological DispanseryDnipro, Ukraine, 49100 Regional Center Of OncologyKharkov, Ukraine, 61070 National Cancer InstituteKyiv, Ukraine, 03022 Vinnytskyi Oblasnyi Klinichnyi Onkolohichnyi Dyspanser, Viddilennia KhimioterapiiVinnytsia, Ukraine, 21029 Zaporizhzhia Medical Academy Of Postgraduate Education, Zaporizhzhia Regoinal Clinical HospitalZaporizhzhia, Ukraine, 69600|Bristol, United Kingdom, Bs2 8Ed Gloucestershire Hospitals Nhs Foundation Trust - CheltenhamCheltenham, United Kingdom, Gl53 7An Derriford Hospital-Department Of Medical OncologyPlymouth, United Kingdom, Pl6 8Qh Southampton General HospitalSouthampton, United Kingdom, So16 6Yd Royal Marsden HospitalSutton, United Kingdom, Sm2 5Ng Clatterbridge Centre For OncologyWirral, United Kingdom, Ch63 4Jy|Phoenix, Arizona, United States, 85004 United States, District Of Columbia Medstar Georgetown University HospitalWashington, District Of Columbia, United States, 20007|Miami, Florida, United States, 33136|Chicago, Illinois, United States, 60612|Louisville, Kentucky, United States, 40202|Ann Arbor, Michigan, United States, 48109-5000|Bronx, New York, United States, 10461 Weill Cornell Medical CollegeNew York, New York, United States, 10029|Charlotte, North Carolina, United States, 28204|Houston, Texas, United States, 77030","Arizona|Florida|Illinois|Kentucky|Michigan|New York|North Carolina|Texas","Australia|Austria|Belgium|Brazil|Canada|China|France|Germany|Greece|Hungary|India|Israel|Italy|Japan|Mexico|Portugal|Spain|Turkey|Ukraine|United Kingdom|United States","Chris O'Brien Lifehouse|Lkh-Univ. Klinikum Graz|Olv Ziekenhuis Aalst|Fundacao Pio Xii - Hospital De Cancer De Barretos|British Columbia Vancouver Cancer Centre|Peking University First Hospital|Institut De CancÃ©rologie De L'Ouest (Ico)|Vivantes Klinikum Am Urban|University General Hospital Of Rio Patras|Semmelweis Egyetem|Sahyadri Speciality Hospital|Rambam Health Care Campus|Ospedale S. Donato - Asl 8 Arezzo|National Cancer Center Hospital East|San Peregrino Cancer Center|Hospital LusÃ­adas|Hosp. Univ. Infanta Cristina|Adana Baskent Practice And Research Hospital|Chernivtsi Regional Clinical Hospital|University Hospitals Bristol - Bristol Haematology & Oncolog|University Of Ua Cancer Center(Uacc)/Dh-Sjhmc|University Of Miami/Sylvester Cancer Center|Northwestern University|Norton Cancer Institute|University Of Michigan Health System|Montefiore Medical Center|Levine Cancer Institute, Carolinas Healthcare System|Md Anderson Cancer Center",{"$nulls":3},"Janssen Research & Development, LLC Clinical Trials","2018-01-29","2020-05-25T16:35:11.528","2020-05-26T17:10:42.972","NCT03390504"]
["5ecbf3bfe2561b1b11905c97","NCT03390504","2018-03-13","Johnson & Johnson","JNJ","Not yet recruiting","A Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Participants With Advanced Urothelial Cancer and Selected Fibroblast Growth Factor Receptor (FGFR) Gene Aberrations","Erdafitinib|Fibroblast|Vinflunine|Docetaxel|Pembrolizumab","FGFR Antagonist|Tubulin Inhibitor|Mitosis Inhibitor|Tubulin Inhibitor|PD-1 Inhibitor","Yes","['Erdafitinib', 'Fibroblast', 'Vinflunine']","No",null,"Phase 3",4,631,"Anticipated","2018-03-31","2020-11-24","OS","Overall Survival",{"$nulls":3},"The purpose of this study is to evaluate efficacy of erdafitinib versus chemotherapy or pembrolizumab in participants with advanced urothelial cancer harboring selected fibroblast growth factor receptor (FGFR) aberrations who have progressed after one prior treatment.","A study of erdafitinib versus standard of care, consisting of chemotherapy (docetaxel or vinflunine) or PD1 agent pembrolizumab, in participants with advanced urothelial cancer and selected FGFR aberrations who have progressed on or after one prior line of systemic therapy. It will consist of screening, treatment phase (from randomization until disease progression, intolerable toxicity, withdrawal of consent or decision by investigator to discontinue treatment else participants will discontinue treatment after completion of 2 years pembrolizumab therapy), post-treatment follow-up (from end-of-treatment to participants death, withdraws consent, lost to follow-up, or end of study, whichever comes first). Efficacy, pharmacokinetics, biomarkers, patient reported outcomes, medical resource utilization and safety will be assessed.","A Phase 3 Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Subjects With Advanced Urothelial Cancer and Selected FGFR Gene Aberrations","CR108401","Urothelial Cancer","Transitional Cell Carcinoma","Oncology Solid Tumor","Oncology","Experimental","Cohort 1 (Arm 1A): Erdafitinib|Cohort 1 (Arm 1B): Vinflunine or Docetaxel|Cohort 2 (Arm 2A): Erdafitinib|Cohort 2 (Arm 2B): Pembrolizumab","Participants will be screened based on Fibroblast Growth Factor Receptor inhibitor Clinical Trial Assay (FGFRi CTA) to determine molecular eligibility and participants who meet molecular eligibility criteria will be enrolled. Participants (treated with prior anti-anti-programmed cell death protein [PD][L]1 agent) will swallow erdafitinib tablets orally at a starting dose of 8 milligram (mg), once daily for 21 days in a 21-day cycle until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustment are based on phosphate level and observed toxicity (adverse events [AEs]).|Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be enrolled. Participants (treated with prior anti-PD[L]1 agent) will receive vinflunine 320 milligram per meter square (mg/m^2) as a 20-minute intravenous infusion once every 3 weeks or docetaxel 75 mg/m^2 as a 1 hour intravenous infusion every 3 weeks. Treatment with either agent (choice of investigator) will be administered until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustments are based on observed toxicities.|Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be enrolled. Participants (no prior treatment with anti-PD(L)1 agent) will swallow erdafitinib tablets orally at a starting dose of 8 mg, once daily for 21 days in a 21-day cycle until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustments are based on phosphate level and observed toxicity (AEs).|Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be enrolled. Participants (no prior treatment with anti-PD(L)1 agent) will receive pembrolizumab 200 mg as a 30-minute intravenous infusion once every 3 weeks, until disease progression, intolerable toxicity, withdrawal of consent, decision by the investigator to discontinue treatment or the completion of 2 years of pembrolizumab therapy. Dose adjustments are based on observed toxicities.","Drug|Device","Erdafitinib|Fibroblast Growth Factor Receptor inhibitor Clinical Trial Assay (FGFRi CTA)|Vinflunine|Docetaxel|Pembrolizumab","Participants will swallow erdafitinib tablets orally at a starting dose of 8 mg.|FGFRi CTA will be used to determine molecular eligibility.|Participants will receive vinflunine 320 mg/m^2 as a 20-minute intravenous infusion.|Participants will receive docetaxel 75 mg/m^2 as a 1 hour intravenous infusion.|Participants will receive pembrolizumab 200 mg as a 30-minute intravenous infusion.","JNJ-42756493","Cohort 1 (Arm 1A): Erdafitinib|Cohort 1 (Arm 1B): Vinflunine or Docetaxel|Cohort 2 (Arm 2A): Erdafitinib|Cohort 2 (Arm 2B): Pembrolizumab","\n\n * Histologic demonstration of transitional cell carcinoma of the urothelium. Minor components ( less than [<] 50 percent [%] overall) of variant histology such as glandular or squamous differentiation, or evolution to more aggressive phenotypes such as sarcomatoid or micropapillary change are acceptable\n * Stage IV disease (metastatic or surgically unresectable, cT4b, N+, or M+ cancer)\n * Documented progression of disease, defined as any progression that requires a change in treatment, prior to randomization\n * Only one line of prior systemic treatment for metastatic urothelial cancer. Participants who received neoadjuvant or adjuvant chemotherapy and showed disease progression (as defined above), within 12 months of the last dose are considered to have received systemic chemotherapy in the metastatic setting Cohort 1: prior chemotherapy and anti-PD(L)1 [in combination or in maintenance setting] (anti-PD(L)1 alone is allowed only for participants with documented cisplatin ineligibility) and Cohort 2: prior chemotherapy (no prior anti-PD(L)1 treatment)\n * A woman of childbearing potential who is sexually active must have a negative pregnancy test (beta human chorionic gonadotropin [beta hCG]) at Screening (urine or serum)\n * Participants must meet appropriate molecular eligibility criteria\n * Eastern Cooperative Oncology Group (ECOG) performance status Grade 0, 1, or 2\n * Adequate bone marrow, liver, and renal function\n\n","\n\n * Treatment with any other investigational agent or participation in another clinical study with therapeutic intent within 30 days prior to randomization\n * Active malignancies (that is, requiring treatment change in the last 24 months) other than urothelial cancer (except skin cancers within the last 24 months that is considered completely cured)\n * Symptomatic central nervous system metastases\n * Received prior fibroblast growth factor receptor (FGFR) inhibitor treatment\n * Known allergies, hypersensitivity, or intolerance to erdafitinib or its excipients\n * Corneal or retinal abnormality likely to increase the risk of eye toxicity\n * History of uncontrolled cardiovascular disease including\n * Impaired wound healing capacity defined as skin/decubitus ulcers, chronic leg ulcers, known gastric ulcers, or unhealed incisions",{"$nulls":4},"Actual","2018-01-04","Actual","Anticipated","2021-05-27","Anticipated","2018-03-01","2017-12-20","2018-01-03","2018-03-11","Yes",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","Yes",{"$nulls":17},"2017-002932-18|42756493BLC3001","EudraCT Number|Janssen Research & Development, LLC","Overall Survival (OS)","Overall survival is measured from the date of randomization to the date of the participant's death. If the participant is alive or the vital status is unknown, the participant will be censored at the date the participant was last known to be alive.","Date of first randomization to the date of participant's death (approximately up to 3 years)","Progression-free Survival (PFS)|Overall Response Rate (ORR)|Time to Worsening in Symptom Items and Functioning Subscales in Patient-Reported Health Status of the Functional Assessment of Cancer Therapy-Bladder Cancer (FACT-Bl)|Change from Baseline in Patient-Global Impression of Severity (PGIS) Score|Change from Baseline in the Visual Analog Scale (VAS) of the EQ-5D-5L|Change from Baseline in the Utility Scale of the EQ-5D-5L|Duration of Response (DOR)|Number of Participants with Adverse Events (AEs) as a Measure of Safety|Oral Clearance (CL/F) of Erdafitinib|Area Under the Plasma Concentration-Time Curve from Time Zero to Time 't' (AUC[0-t]) of Erdafitinib","PFS is defined as duration in days from date of randomization to disease progression date (assessed per Response Evaluation Criteria in Solid Tumors Version 1.1|ORR is defined as the proportion of participants who achieve CR (CR; disappearance of all target lesions and disappearance of all non-target lesions and normalization of tumor marker level) or partial response (PR; at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters), as assessed per RECIST v1.1 by the investigator.|The FACT-Bl consists of 36 core items, with 5-point Likert response scales, covering 5 primary domains: Physical well-being, social/family well-being, emotional well-being, functional well-being and bladder symptom subscale. The answer scales range from \"Not at all (score=0)\" to \"very much (score=4)\" to assess the meaningful significant symptom deterioration.|The PGIS is a single question regarding the participant report of disease severity. Participants will be asked that ''considering all aspects of your bladder cancer symptoms right now, would you say your bladder cancer symptoms are none, mild, moderate, severe, or very severe?\" The PGIS is an anchor question that will be used to establish the magnitude of meaningful change in this study by assessing disease severity.|European Quality of Life 5 Dimensions (EQ-5D) visual analog scale (VAS) is a 20 centimeter (cm) vertical VAS with scores ranging from 0 (worst imaginable health) to 100 (perfect health). A higher score indicates an improvement in health in the Health Status Index.|The EuroQol-5 is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating \"full health\" and 0 representing dead.|DOR for responders is defined as duration in days from the date of initial documentation of a response to the date of first documented evidence of progressive disease (PD) or relapse for participants who experience CR (CR; disappearance of all target lesions and disappearance of all non-target lesions and normalization of tumor marker level) during the study or death.|An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.|CL/F is the oral clearance; that is clearance based on oral bioavailability of erdafitinib.|AUC(0-t) is the area under the plasma concentration-time curve from time zero to any time 't' of erdafitinib.","RECIST v1.1 by investigator) or relapse from CR or death, whichever is reported first. RECIST 1.1, progressive disease is defined as a 20 percent (%) increase in the sum of diameters of all target lesions and a minimum absolute increase of 5 millimeter (mm) in the sum. CR is defined as disappearance of all target lesions, non-target lesions and normalization of tumor marker level.|Approximately up to 3 years|Baseline up to end of treatment (approximately 3 years)|Baseline up to follow up phase (approximately 3 years)|From the date of initial documentation of a response to date of first documented evidence of progressive disease (or participants relapse who experience CR during the study) or death (approximately up to 3 years)|Day 14 (Cycle 1), Day 1 (Cycle 2) (each cycle is of 21 days)","JNJ.CT@sylogent.com","Study Contact","844-434-4210","Camperdown, Australia, 2050 Peninsula & South Eastern Haematology And Oncology GroupFrankston, Australia, 3199 Royal Hobart HospitalHobart, Australia, 7000 Frankston HospitalMelbourne, Australia, 3199 Southside Cancer Care CentreMiranda, Australia, 2228 Sir Charles Gairdner HospitalNedlands, Australia, 6009|Graz, Austria, 8036 Krankenhaus Der Barmherzigen SchwesternLinz, Austria, 4010 Lkh - UniversitÃ¤tsklinikum Der Pmu SalzburgSalzburg, Austria, 5020 Medical University Vienna, MuvVienna, Austria, A-1090|Aalst, Belgium, 9300 Zna MiddelheimAntwerpen, Belgium, 2020 Cliniques Universitaires Saint-LucBrussel, Belgium, 1200 Clinique Notre Dame De GrÃ¢ceCharleroi, Belgium, 6000 Az Maria MiddelaresGent, Belgium, 9000 Universitair Ziekenhuis GentGent, Belgium, 9000 Chc-Cliniques Saint-JosephLiÃ¨ge, Belgium, 4000 Sint-Augustinus AzWilrijk, Belgium, 2610 Chu Dinant Godinne Ucl NamurYvoir, Belgium, 5530|Barretos, Brazil, 14784-400 AssociaÃ§Ã£o MÃ¡rio Penna\\NÃºcleo De Ensino E PesquisasBelo Horizonte, Brazil, 30380-472 Hospital Erasto GaertnerCuritiba, Brazil, 81520-060 ClÃ­nica De Neoplasias Litoral Ltda.Itajai, Brazil, 88301-220 Upco - HcpaPorto Alegre, Brazil, 90035-903 Inca - Instituto Nacional Do CancerRio De Janeiro, Brazil, 20231-050 Fundacao Antonio PrudenteSao Paulo, Brazil, 01509900 Hospital De Base De SÃ£o JosÃ© Do Rio PretoSÃ£o JosÃ© Do Rio Preto, Brazil, 15090-000 Sociedade Beneficiante De Senhoras - Hospital Sirio LibanesSÃ£o Paulo, Brazil, 01308901 Cepho - Faculdade De Medicina Do AbcSÃ£o Paulo, Brazil, 09060-650|Vancouver, British Columbia, Canada, V5Z 4E6|Winnipeg, Manitoba, Canada, R3E 0V9|Beijing, China, 100034 Peking University Third HospitalBeijing, China, 100191 Beijing HospitalBeijing, China, 100730 Sun Yat-Sen Memorial Hospital, Sun Yat-Sen UniversityGuangzhou, China, 510120 Sir Run Run Shaw Hospital, Zhejiang UniversityHangzhou, China, 310016 Nanjing Drum Tower HospitalNanjing, China, 210008 Jiangsu Cancer HospitalNanjing, China, 210009 Renji Hospital, Shanghai Jiaotong University School Of MedicineShanghai, China, 200127 Huadong Hospital Affiliated To Fudan UniversityShanghai, China, 200400 First Affiliated Hospital, Xi'An Jiaotong UniversityXi'An, China, 710061|Angers, France, 49055 Hopital Jean MinjozBesancon Cedex, France, 25030 Institut BergoniÃ©Bordeaux, France, 33000 Hopital Henri MondorCreteil, France, 94010 Centre Georges-FranÃ§ois LeclercDijon, France, 21079 Centre Oscar LambretLille, France, 59020 Centre Leon BÃ©rardLyon, France, 69008 Hopital De La TimoneMarseille, France, 13005 Institut Regional Du Cancer De Montpellier Val D'AurelleMontpellier, France, 34298 Centre Antoine LacassagneNice, France, 06189 Institut De CancÃ©rologie Du GardNÃ®mes, France, 30029 Hopital Europeen Georges-PompidouParis, France, 75015 Hospices Civils De Lyon HclPierre-BÃ©nite, France, 69495 Chu De PoitiersPoitiers Cedex, France, 86021 Centre Hopitalier Inter-Communal De CornouailleQuimper, France, 2900 Centre Eugene MarquisRennes Cedex, France, 35062 I.C.O. RenÃ© GauducheauSaint Herblain Cedex, France, 44805 Institut De CancÃ©rologie De LoireSaint-Priest-En-Jarez, France, 42271 Hopitaux Universitaires De StrasbourgStrasbourg, France, 67091 Institut Claudius RegaudToulouse, France, 31059 Institut Gustave RoussyVillejuif, France, 94805|Berlin, Germany, 10967 Universitatsklinikum Carl Gustav Carcus DresdenDresden, Germany, 01307 Universitaetsklinikum DuesseldorfDuesseldorf, Germany, 40225 Friedrich-Alexander Universitaet Urologische UniversitaetsklErlangen, Germany, 91054 Universitatsklinikum FreiburgFreiburg, Germany, 79106 UniversitÃ¤tsmedizin GreifswaldGreifswald, Germany, 17475 UniversitÃ¤tsmedizin GÃ¶ttingenGÃ¶ttingen, Germany, 37099 Asklepios Klinik AltonaHamburg, Germany, 22763 Medizinische Hochschule HannoverHannover, Germany, 30625 UniversitÃ¤tsklinikum Des SaarlandesHomburg/Saar, Germany, 66421 Universitaetsklinikum MuensterMuenster, Germany, 48149 Studienpraxis Urologie Drs. FeyerabendNuertingen, Germany, 72622 Kliniken Nordoberpfalz Ag/Klinikum WeidenWeiden, Germany, 92637|AchaÃ¯a, Greece, 26504 University Of Athens Medical School - Regional General HospiAthina, Greece, 115 28 University Hospital Of HeraklionHeraklion, Greece, 71110 University Hospital Of LarissaLarisa, Greece, 41110 Interbalkan European Medical CenterThessaloniki, Greece, 14564|Budapest, Hungary, 1082 Orszagos Onkologiai IntezetBudapest, Hungary, 1122 Uzsoki Utcai KorhazBudapest, Hungary, H-1145 Szabolcs-Szatmar-Bereg Megyei Korhazak Es Egyetemi OktatokorhazNyÃ­regyhÃ¡za, Hungary, 04400 Pecsi TudomanyegyetemPÃ©cs, Hungary, 7624|Chennai, India, 600035 Bhagwan Mahaveer Hospital & Research CentreJaipur, India, 302017 Sahyadri Speciality HospitalPune, India, 411001 Deenanath Mangeshkar Hospital And Research CentrePune, India, 411004|Haifa, Israel, 31096 Hadassah Medical CenterJerusalem, Israel, 91120 Meir Medical CenterKfar Saba, Israel, 44281 Rabin Medical Center, Beilinson HospitalPetach Tikvah, Israel, 49100 The Chaim Sheba Medical CenterTel Hashomer, Israel, 52621 Yitzhak Shamir Medical CenterZerifin, Israel, 70300|Alessandria, Italy, 15121 Ospedale S. Donato - Asl 8 ArezzoArezzo, Italy, 52100 Cro, Irccs, Istituto Nazionale TumoriAviano, Italy, 33081 Azienda Ospedaliera Papa Giovanni XxiiiBergamo, Italy, 24127 Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia Presidio Spedali CiviliBrescia, Italy, 25123 Istituti Ospitalieri Di Cremona, Ao Di CremonaCremona, Italy, 26100 Policlinico Hospital San Martino- Irccs For OncologyGenova, Italy, 16132 Irst Meldola - ForlÃ¬Meldola, Italy, 47014 Fondazione Irccs Istituto Nazionale Dei TumoriMilano, Italy, 20133 European Institute Of OncologyMilano, Italy, 20141 Aou Policlinico Di ModenaModena, Italy, 41124 Irccs-Fondazione PascaleNapoli, Italy, 80131 Ospedale Maggiore Della CaritÃ Novara, Italy, 28100 Aou San Luigi GonzagaOrbassano, Italy, 10043 Istituto Oncologico Veneto Iov Irccs PadovaPadova, Italy, 35128 Aou Di ParmaParma, Italy, 43126 Irccs Policlinico San MatteoPavia, Italy, 27100 Azienda Ospedaliero Universitaria PisanaPisa, Italy, 56126 Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria Alle ScotteSiena, Italy, 53100 Oncologia Medica-CittÃ  Della Salute E Della Scienza Di TorinoTorino, Italy, 10123 Azienda Ospedaliero - Universitaria Ospedali RiunitiTorrette Di Ancona, Italy, 60126|Hirosaki, Japan, 036-8563 National Cancer Center Hospital EastKashiwa, Japan, 277-8577 Kagawa University HospitalKita-Gun, Japan, 761-0793 Kobe City Medical Center General HospitalKobe, Japan, 650-0047 Dokkyo Medical University Koshigaya HospitalKoshigaya, Japan, 343-8555 National Shikoku Cancer CenterMatsuyama, Japan, 791-0280 Nagano Municipal HospitalNagano, Japan, 381-8551 Aichi Cancer Center HospitalNagoya-Shi, Japan, 464-8681 Kinki University HospitalOsaka-Sayama, Japan, 589-8511 Osaka Medical Center For Cancer And Cardiovascular DiseasesOsaka, Japan, 537-8511 Osaka City University HospitalOsaka, Japan, 545-8586 Kitasato University HospitalSagamihara, Japan, 252-0375 Toho University Sakura Medical CenterSakura, Japan, 285-8741 National Hospital, Hokkaido Cancer CenterSapporo, Japan, 003-0804 Tokyo Women'S Medical University HospitalShinjuku-Ku, Japan, 162-8666 University Of Tsukuba HospitalTsukuba, Japan, 305-8576 Yamaguchi University HospitalUbe, Japan, 755-8505 Yokohama City University Medical CenterYokohama, Japan, 232-0024 Korea, Republic Of Pusan National University Hospital.Busan, Korea, Republic Of, 49241 Chungnam National University HospitalDaejeon, Korea, Republic Of, 35015 National Cancer CenterGoyangsi, Korea, Republic Of, 410-769 Gachon University Gil Medical CenterIncheon, Korea, Republic Of, 21565 Seoul National University Bundang HospitalSeongnam, Korea, Republic Of, 463-707 Korea University Anam HospitalSeoul, Korea, Republic Of, 02841 Seoul National University HospitalSeoul, Korea, Republic Of, 03080 Severance Hospital, Yonsei University Health SystemSeoul, Korea, Republic Of, 03722 Samsung Medical CenterSeoul, Korea, Republic Of, 135-710 Yonsei University Wonju Severance Christian HospitalWonju-Si, Korea, Republic Of, 26426|Aguascalientes, Mexico, 20230 Centro Estatal De CancerologÃ­a De ChihuahuaChihuahua, Mexico, 31000|Nijmegen, Netherlands, 6525 Ga|Lisboa, Portugal, 1500-458 H. Santa Maria - Centro Hospitalar De Lisboa NorteLisboa, Portugal, 1649-035 Hospital Santo Antonio Dos CapuchosLisboa, Portugal, G1R 2J6 Champalimaud Foundation Champalimaud CentreLisbon, Portugal, 1400-038 Instituto Portugues De OncologiaPorto, Portugal, 4200072 Russian Federation Altai Regional Oncology DispensaryBarnaul, Russian Federation, 656049 Chelyabinsk Regional Clinical Center Of Oncology And Nuclear MedicineChelyabinsk, Russian Federation, 454087 Ivanovo Regional Oncology DispensaryIvanovo, Russian Federation, 153040 Fsbsi 'N. N. Blokhin Russian Cancer Research Center'Moscow, Russian Federation, 115478 Russian Scientific Center Of RoentgenoradiologyMoscow, Russian Federation, 117997 Hertzen Oncology Research InstituteMoscow, Russian Federation, 125284 Privolzhsky District Medical Center Under The Federal Medico-Biological AgencyNizhni Novgorod, Russian Federation, 603109 National Medical Radiological Research CenterObninsk, Russian Federation, 249036 Clinical Oncology DispensaryOmsk, Russian Federation, 644013 Gbuz Of Stavropol Region Pyatigorsk Oncological DispensaryPyatigorsk, Russian Federation, 357502 City Polyprofiled Hospital #2Saint Petersburg, Russian Federation, 194354 Pavlov First Saint Petersburg State Medical UniversitySaint Petersburg, Russian Federation, 197022 Clinical Hopital N/A Petra VelikogoSaint-Petersburg, Russian Federation, 195067 National Research Mordovia State UniversitySaransk, Russian Federation, 430032 Russian Scientific Center Of Radiology And Surgical TechnologiesSt. Petersburg, Russian Federation, 197758 Northen-Western State Medical University N.A. I.I. MechnikovSt.Petersburg, Russian Federation, 191015 Llc BioeqSt.Petersburg, Russian Federation, 197342 Multifunctional Clinical Medical Center 'Medical City'Tyumen, Russian Federation, 625041|Badajoz, Spain, 06006 Institut CatalÃ  D'Oncologia-Hospital Universitari Germans Trias I PujolBadalona, Spain, 08916 Hosp. Clinic I Provincial De BarcelonaBarcelona, Spain, 08036 Hosp. De La Santa Creu I Sant PauBarcelona, Spain, 08041 Hosp. Reina SofiaCÃ³rdoba, Spain, 14004 Hosp. Univ. Virgen De Las NievesGranada, Spain, 18014 Complejo Hospitalario De JaenJaÃ©n, Spain, 23007 Hosp. Univ. Lucus AugustiLugo, Spain, 27003 Hosp. Gral. Univ. Gregorio MaraÃ±onMadrid, Spain, 28009 Centro Oncologico Md AndersonMadrid, Spain, 28033 Hosp. Univ. La PazMadrid, Spain, 28046 Hosp. Univ. Pta. De Hierro MajadahondaMajadahonda, Spain, 28220 Althaia, Xarxa Assistencial UniversitÃ ria De ManresaManresa, Spain, 08243 Hosp. Virgen De La VictoriaMÃ¡laga, Spain, 29010 Hosp. De NavarraPamplona, Spain, 31008 Hosp. Virgen MacarenaSevilla, Spain, 41009 Hosp. Virgen Del RocioSevilla, Spain, 41013 Hosp. Univ. I Politecni La FeValencia, Spain, 46026 Hosp. Univ. Miguel ServetZaragoza, Spain, 50009 Taiwan Kaohsiung Medical University Chung-Ho Memorial HospitalKaohsiung, Taiwan, 807 Chi Mei Medical Center - Liu YingLiou Ying Township, Taiwan, 736 Chang Gung Medical FoundationNiao-Sung Hsiang, Taiwan, 833 Taichung Veterans General HospitalTaichung, Taiwan, 40705 National Cheng Kung University HospitalTainan, Taiwan, 70403 National Taiwan University HospitalTaipei City, Taiwan, 10002 Mackay Memorial HospitalTaipei, Taiwan, 10449 Taipei Veterans General HospitalTaipei, Taiwan, 11217 Koo Foundation Sun Yat-Sen Cancer CenterTaipei, Taiwan, 11259 Chang-Gung Memorial Hospital, Linkou BranchTaoyuan, Taiwan, 333|Adana, Turkey, 01120 Hacettepe University Medical FacultyAnkara, Turkey, 6100 Bezmialem University Medical FacultyIstanbul, Turkey, 34093 Medipol Mega University HospitalIstanbul, Turkey, 34214 Marmara University Medical FacultyIstanbul, Turkey, 34890 Istanbul Medeniyet University Goztepe Training And Research HospitalIstanbul, Turkey, 81450 Ege UniversityIzmir, Turkey, 35100 Dokuz Eylul Universitesi Tip FakultesiIzmir, Turkey, 35340 Kocaeli University Medical FacultyKocaeli, Turkey Inonu Universitesi Turgut Ozal Tip Merkezi, Ic HastaliklariMalatya, Turkey, 44400|Chernivtsi, Ukraine, 58002 Mi Dnipropetrovsk Region Clinical Hospital N A I.I.MechnikovDnipropetrovsk, Ukraine, 49005 Komunalnyi Zaklad Miska Bahatoprofilna Klinichna Likarnia #4Dnipropetrovsk, Ukraine, 49102 Regional Oncological DispanseryDnipro, Ukraine, 49100 Oblasna Klinichna Likarnia - Urolohichne ViddilenniaIvano-Frankivsk, Ukraine, 76018 Regional Center Of OncologyKharkov, Ukraine, 61070 National Cancer InstituteKyiv, Ukraine, 03022 Transkarpathian Regional University Oncology ClinicUzhgorod, Ukraine, 88000 Vinnytskyi Oblasnyi Klinichnyi Onkolohichnyi Dyspanser, Viddilennia KhimioterapiiVinnytsia, Ukraine, 21029 ZaokodZaporizhzhia, Ukraine, 69040 Zaporizhzhia Medical Academy Of Postgraduate Education, Zaporizhzhia Regoinal Clinical HospitalZaporizhzhia, Ukraine, 69600|Bristol, United Kingdom, Bs2 8Ed Gloucestershire Hospitals Nhs Foundation Trust - CheltenhamCheltenham, United Kingdom, Gl53 7An Sarah Cannon Research InstituteLondon, United Kingdom, W1G 6Ad Charing Cross HospitalLondon, United Kingdom, W6 8Rf The Christie Nhs Foundation Trust - Christie HospitalManchester, United Kingdom, M20 4Bx Derriford Hospital-Department Of Medical OncologyPlymouth, United Kingdom, Pl6 8Qh Southampton General HospitalSouthampton, United Kingdom, So16 6Yd Royal Marsden HospitalSutton, United Kingdom, Sm2 5Ng Clatterbridge Centre For OncologyWirral, United Kingdom, Ch63 4Jy|Phoenix, Arizona, United States, 85004 United States, District Of Columbia Medstar Georgetown University HospitalWashington, District Of Columbia, United States, 20007|Miami, Florida, United States, 33136|Atlanta, Georgia, United States, 30318-0922|Chicago, Illinois, United States, 60612|Louisville, Kentucky, United States, 40202|Ann Arbor, Michigan, United States, 48109-5000|Bronx, New York, United States, 10461 Weill Cornell Medical CollegeNew York, New York, United States, 10029|Charlotte, North Carolina, United States, 28204 Duke UniversityDurham, North Carolina, United States, 27701|Houston, Texas, United States, 77030","Arizona|Florida|Georgia|Illinois|Kentucky|Michigan|New York|North Carolina|Texas","Australia|Austria|Belgium|Brazil|Canada|China|France|Germany|Greece|Hungary|India|Israel|Italy|Japan|Mexico|Netherlands|Portugal|Spain|Turkey|Ukraine|United Kingdom|United States","Chris O'Brien Lifehouse|Lkh-Univ. Klinikum Graz|Olv Ziekenhuis Aalst|Fundacao Pio Xii - Hospital De Cancer De Barretos|British Columbia Vancouver Cancer Centre|Manitoba Cancercare Manitoba|Peking University First Hospital|Institut De CancÃ©rologie De L'Ouest (Ico)|Vivantes Klinikum Am Urban|University General Hospital Of Rio Patras|Semmelweis Egyetem|Apollo Specialty Hospital|Rambam Health Care Campus|Azienda Ospedaliera Nazionale Ss. Antonio E Biagio E Cesare Arrigo Alessandria|Hirosaki University School Of Medicine & Hospital|San Peregrino Cancer Center|Radboud Umcn|Hospital LusÃ­adas|Hosp. Univ. Infanta Cristina|Adana Baskent Practice And Research Hospital|Chernivtsi Regional Clinical Hospital|University Hospitals Bristol - Bristol Haematology & Oncolog|University Of Ua Cancer Center(Uacc)/Dh-Sjhmc|University Of Miami/Sylvester Cancer Center|Piedmont Cancer Institute|Northwestern University|Norton Cancer Institute|University Of Michigan Health System|Montefiore Medical Center|Levine Cancer Institute, Carolinas Healthcare System|Md Anderson Cancer Center",{"$nulls":3},"Janssen Research & Development, LLC Clinical Trials","2018-03-11","2020-05-25T16:35:11.578","2020-05-26T17:10:42.972","NCT03390504"]
["5ecbf3bf11702c1b1b9169b0","NCT03390504","2018-05-03","Johnson & Johnson","JNJ","Recruiting","A Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Participants With Advanced Urothelial Cancer and Selected Fibroblast Growth Factor Receptor (FGFR) Gene Aberrations","Erdafitinib|Fibroblast|Vinflunine|Docetaxel|Pembrolizumab","FGFR Antagonist|Tubulin Inhibitor|Mitosis Inhibitor|Tubulin Inhibitor|PD-1 Inhibitor","Yes","['Erdafitinib', 'Fibroblast', 'Vinflunine']","No",null,"Phase 3",4,631,"Anticipated","2018-03-23","2020-11-24","OS","Overall Survival",{"$nulls":3},"The purpose of this study is to evaluate efficacy of erdafitinib versus chemotherapy or pembrolizumab in participants with advanced urothelial cancer harboring selected fibroblast growth factor receptor (FGFR) aberrations who have progressed after one prior treatment.","A study of erdafitinib versus standard of care, consisting of chemotherapy (docetaxel or vinflunine) or PD1 agent pembrolizumab, in participants with advanced urothelial cancer and selected FGFR aberrations who have progressed on or after one prior line of systemic therapy. It will consist of screening, treatment phase (from randomization until disease progression, intolerable toxicity, withdrawal of consent or decision by investigator to discontinue treatment else participants will discontinue treatment after completion of 2 years pembrolizumab therapy), post-treatment follow-up (from end-of-treatment to participants death, withdraws consent, lost to follow-up, or end of study, whichever comes first). Efficacy, pharmacokinetics, biomarkers, patient reported outcomes, medical resource utilization and safety will be assessed.","A Phase 3 Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Subjects With Advanced Urothelial Cancer and Selected FGFR Gene Aberrations","CR108401","Urothelial Cancer","Transitional Cell Carcinoma","Oncology Solid Tumor","Oncology","Experimental","Cohort 1 (Arm 1A): Erdafitinib|Cohort 1 (Arm 1B): Vinflunine or Docetaxel|Cohort 2 (Arm 2A): Erdafitinib|Cohort 2 (Arm 2B): Pembrolizumab","Participants will be screened based on Fibroblast Growth Factor Receptor inhibitor Clinical Trial Assay (FGFRi CTA) to determine molecular eligibility and participants who meet molecular eligibility criteria will be enrolled. Participants (treated with prior anti-anti-programmed cell death protein [PD][L]1 agent) will swallow erdafitinib tablets orally at a starting dose of 8 milligram (mg), once daily for 21 days in a 21-day cycle until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustment are based on phosphate level and observed toxicity (adverse events [AEs]).|Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be enrolled. Participants (treated with prior anti-PD[L]1 agent) will receive vinflunine 320 milligram per meter square (mg/m^2) as a 20-minute intravenous infusion once every 3 weeks or docetaxel 75 mg/m^2 as a 1 hour intravenous infusion every 3 weeks. Treatment with either agent (choice of investigator) will be administered until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustments are based on observed toxicities.|Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be enrolled. Participants (no prior treatment with anti-PD(L)1 agent) will swallow erdafitinib tablets orally at a starting dose of 8 mg, once daily for 21 days in a 21-day cycle until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustments are based on phosphate level and observed toxicity (AEs).|Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be enrolled. Participants (no prior treatment with anti-PD(L)1 agent) will receive pembrolizumab 200 mg as a 30-minute intravenous infusion once every 3 weeks, until disease progression, intolerable toxicity, withdrawal of consent, decision by the investigator to discontinue treatment or the completion of 2 years of pembrolizumab therapy. Dose adjustments are based on observed toxicities.","Drug|Device","Erdafitinib|Fibroblast Growth Factor Receptor inhibitor Clinical Trial Assay (FGFRi CTA)|Vinflunine|Docetaxel|Pembrolizumab","Participants will swallow erdafitinib tablets orally at a starting dose of 8 mg.|FGFRi CTA will be used to determine molecular eligibility.|Participants will receive vinflunine 320 mg/m^2 as a 20-minute intravenous infusion.|Participants will receive docetaxel 75 mg/m^2 as a 1 hour intravenous infusion.|Participants will receive pembrolizumab 200 mg as a 30-minute intravenous infusion.","JNJ-42756493","Cohort 1 (Arm 1A): Erdafitinib|Cohort 1 (Arm 1B): Vinflunine or Docetaxel|Cohort 2 (Arm 2A): Erdafitinib|Cohort 2 (Arm 2B): Pembrolizumab","\n\n * Histologic demonstration of transitional cell carcinoma of the urothelium. Minor components ( less than [<] 50 percent [%] overall) of variant histology such as glandular or squamous differentiation, or evolution to more aggressive phenotypes such as sarcomatoid or micropapillary change are acceptable\n * Stage IV disease (metastatic or surgically unresectable, cT4b, N+, or M+ cancer)\n * Documented progression of disease, defined as any progression that requires a change in treatment, prior to randomization\n * Only one line of prior systemic treatment for metastatic urothelial cancer. Participants who received neoadjuvant or adjuvant chemotherapy and showed disease progression (as defined above), within 12 months of the last dose are considered to have received systemic chemotherapy in the metastatic setting Cohort 1: prior chemotherapy and anti-PD(L)1 [in combination or in maintenance setting] (anti-PD(L)1 alone is allowed only for participants with documented cisplatin ineligibility) and Cohort 2: prior chemotherapy (no prior anti-PD(L)1 treatment)\n * A woman of childbearing potential who is sexually active must have a negative pregnancy test (beta human chorionic gonadotropin [beta hCG]) at Screening (urine or serum)\n * Participants must meet appropriate molecular eligibility criteria\n * Eastern Cooperative Oncology Group (ECOG) performance status Grade 0, 1, or 2\n * Adequate bone marrow, liver, and renal function\n\n","\n\n * Treatment with any other investigational agent or participation in another clinical study with therapeutic intent within 30 days prior to randomization\n * Active malignancies (that is, requiring treatment change in the last 24 months) other than urothelial cancer (except skin cancers within the last 24 months that is considered completely cured)\n * Symptomatic central nervous system metastases\n * Received prior fibroblast growth factor receptor (FGFR) inhibitor treatment\n * Known allergies, hypersensitivity, or intolerance to erdafitinib or its excipients\n * Corneal or retinal abnormality likely to increase the risk of eye toxicity\n * History of uncontrolled cardiovascular disease including\n * Impaired wound healing capacity defined as skin/decubitus ulcers, chronic leg ulcers, known gastric ulcers, or unhealed incisions",{"$nulls":4},"Actual","2018-01-04","Actual","Anticipated","2021-05-27","Anticipated","2018-04-01","2017-12-20","2018-01-03","2018-05-01","Yes",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No",null,null,"URL: http://pam.sylogent.com/cr/CR108401 [http://pam.sylogent.com/cr/CR108401] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To learn how to participate in this trial please click here.",null,"Yes","Yes",{"$nulls":17},"2017-002932-18|42756493BLC3001","EudraCT Number|Janssen Research & Development, LLC","Overall Survival (OS)","Overall survival is measured from the date of randomization to the date of the participant's death. If the participant is alive or the vital status is unknown, the participant will be censored at the date the participant was last known to be alive.","Date of first randomization to the date of participant's death (approximately up to 3 years)","Progression-free Survival (PFS)|Overall Response Rate (ORR)|Time to Worsening in Symptom Items and Functioning Subscales in Patient-Reported Health Status of the Functional Assessment of Cancer Therapy-Bladder Cancer (FACT-Bl)|Change from Baseline in Patient-Global Impression of Severity (PGIS) Score|Change from Baseline in the Visual Analog Scale (VAS) of the EQ-5D-5L|Change from Baseline in the Utility Scale of the EQ-5D-5L|Duration of Response (DOR)|Number of Participants with Adverse Events (AEs) as a Measure of Safety|Oral Clearance (CL/F) of Erdafitinib|Area Under the Plasma Concentration-Time Curve from Time Zero to Time 't' (AUC[0-t]) of Erdafitinib","PFS is defined as duration in days from date of randomization to disease progression date (assessed per Response Evaluation Criteria in Solid Tumors Version 1.1|ORR is defined as the proportion of participants who achieve CR (CR; disappearance of all target lesions and disappearance of all non-target lesions and normalization of tumor marker level) or partial response (PR; at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters), as assessed per RECIST v1.1 by the investigator.|The FACT-Bl consists of 36 core items, with 5-point Likert response scales, covering 5 primary domains: Physical well-being, social/family well-being, emotional well-being, functional well-being and bladder symptom subscale. The answer scales range from \"Not at all (score=0)\" to \"very much (score=4)\" to assess the meaningful significant symptom deterioration.|The PGIS is a single question regarding the participant report of disease severity. Participants will be asked that ''considering all aspects of your bladder cancer symptoms right now, would you say your bladder cancer symptoms are none, mild, moderate, severe, or very severe?\" The PGIS is an anchor question that will be used to establish the magnitude of meaningful change in this study by assessing disease severity.|European Quality of Life 5 Dimensions (EQ-5D) visual analog scale (VAS) is a 20 centimeter (cm) vertical VAS with scores ranging from 0 (worst imaginable health) to 100 (perfect health). A higher score indicates an improvement in health in the Health Status Index.|The EuroQol-5 is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating \"full health\" and 0 representing dead.|DOR for responders is defined as duration in days from the date of initial documentation of a response to the date of first documented evidence of progressive disease (PD) or relapse for participants who experience CR (CR; disappearance of all target lesions and disappearance of all non-target lesions and normalization of tumor marker level) during the study or death.|An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.|CL/F is the oral clearance; that is clearance based on oral bioavailability of erdafitinib.|AUC(0-t) is the area under the plasma concentration-time curve from time zero to any time 't' of erdafitinib.","RECIST v1.1 by investigator) or relapse from CR or death, whichever is reported first. RECIST 1.1, progressive disease is defined as a 20 percent (%) increase in the sum of diameters of all target lesions and a minimum absolute increase of 5 millimeter (mm) in the sum. CR is defined as disappearance of all target lesions, non-target lesions and normalization of tumor marker level.|Approximately up to 3 years|Baseline up to end of treatment (approximately 3 years)|Baseline up to follow up phase (approximately 3 years)|From the date of initial documentation of a response to date of first documented evidence of progressive disease (or participants relapse who experience CR during the study) or death (approximately up to 3 years)|Day 14 (Cycle 1), Day 1 (Cycle 2) (each cycle is of 21 days)","JNJ.CT@sylogent.com","Study Contact","844-434-4210","Camperdown, Australia, 2050 Peninsula & South Eastern Haematology And Oncology GroupFrankston, Australia, 3199 Royal Hobart HospitalHobart, Australia, 7000 Peter Maccallum Cancer CentreMelbourne, Australia, 3000 Frankston HospitalMelbourne, Australia, 3199 Southside Cancer Care CentreMiranda, Australia, 2228 Sir Charles Gairdner HospitalNedlands, Australia, 6009|Graz, Austria, 8036 Krankenhaus Der Barmherzigen SchwesternLinz, Austria, 4010 Lkh - UniversitÃ¤tsklinikum Der Pmu SalzburgSalzburg, Austria, 5020 Medical University Vienna, MuvVienna, Austria, A-1090|Aalst, Belgium, 9300 Zna MiddelheimAntwerpen, Belgium, 2020 Cliniques Universitaires Saint-LucBrussel, Belgium, 1200 Clinique Notre Dame De GrÃ¢ceCharleroi, Belgium, 6000 Az Maria MiddelaresGent, Belgium, 9000 Universitair Ziekenhuis GentGent, Belgium, 9000 Chc-Cliniques Saint-JosephLiÃ¨ge, Belgium, 4000 Sint-Augustinus AzWilrijk, Belgium, 2610 Chu Dinant Godinne Ucl NamurYvoir, Belgium, 5530|Barretos, Brazil, 14784-400 AssociaÃ§Ã£o MÃ¡rio Penna\\NÃºcleo De Ensino E PesquisasBelo Horizonte, Brazil, 30380-472 Hospital Erasto GaertnerCuritiba, Brazil, 81520-060 ClÃ­nica De Neoplasias Litoral Ltda.Itajai, Brazil, 88301-220 Upco - HcpaPorto Alegre, Brazil, 90035-903 Inca - Instituto Nacional Do CancerRio De Janeiro, Brazil, 20231-050 Fundacao Antonio PrudenteSao Paulo, Brazil, 01509900 Hospital De Base De SÃ£o JosÃ© Do Rio PretoSÃ£o JosÃ© Do Rio Preto, Brazil, 15090-000 Sociedade Beneficiante De Senhoras - Hospital Sirio LibanesSÃ£o Paulo, Brazil, 01308901 Cepho - Faculdade De Medicina Do AbcSÃ£o Paulo, Brazil, 09060-650|Vancouver, British Columbia, Canada, V5Z 4E6|Winnipeg, Manitoba, Canada, R3E 0V9|Beijing, China, 100034 Beijing Friendship HospitalBeijing, China, 100050 Peking University Third HospitalBeijing, China, 100191 Beijing HospitalBeijing, China, 100730 Peking Union Medical College HospitalBeijing, China, 100730 Sichuan Provincial People'S HospitalChengdu, China, 610000 Sun Yat-Sen Memorial Hospital, Sun Yat-Sen UniversityGuangzhou, China, 510120 Zhejiang Provincial People'S HospitalHangzhou, China, 310000 Sir Run Run Shaw Hospital, Zhejiang UniversityHangzhou, China, 310016 Nanjing Drum Tower HospitalNanjing, China, 210008 Jiangsu Cancer HospitalNanjing, China, 210009 Renji Hospital, Shanghai Jiaotong University School Of MedicineShanghai, China, 200127 Huadong Hospital Affiliated To Fudan UniversityShanghai, China, 200400 First Affiliated Hospital, Xi'An Jiaotong UniversityXi'An, China, 710061|Angers, France, 49055 Hopital Jean MinjozBesancon Cedex, France, 25030 Institut BergoniÃ©Bordeaux, France, 33000 Centre Jean PerrinClermont Ferrand, France, 63011 Hopital Henri MondorCreteil, France, 94010 Centre Georges-FranÃ§ois LeclercDijon, France, 21079 Centre Oscar LambretLille, France, 59020 Centre Leon BÃ©rardLyon, France, 69008 Hopital De La TimoneMarseille, France, 13005 Institut Regional Du Cancer De Montpellier Val D'AurelleMontpellier, France, 34298 Centre Antoine LacassagneNice, France, 06189 Institut De CancÃ©rologie Du GardNÃ®mes, France, 30029 Hopital Europeen Georges-PompidouParis, France, 75015 Hospices Civils De Lyon HclPierre-BÃ©nite, France, 69495 Chu De PoitiersPoitiers Cedex, France, 86021 Centre Hopitalier Inter-Communal De CornouailleQuimper, France, 2900 Centre Eugene MarquisRennes Cedex, France, 35062 I.C.O. RenÃ© GauducheauSaint Herblain Cedex, France, 44805 Institut De CancÃ©rologie De LoireSaint-Priest-En-Jarez, France, 42271 Hopitaux Universitaires De StrasbourgStrasbourg, France, 67091 Institut Claudius RegaudToulouse, France, 31059 Institut Gustave RoussyVillejuif, France, 94805|Berlin, Germany, 10967 Universitatsklinikum Carl Gustav Carcus DresdenDresden, Germany, 01307 Universitaetsklinikum DuesseldorfDuesseldorf, Germany, 40225 Friedrich-Alexander Universitaet Urologische UniversitaetsklErlangen, Germany, 91054 Universitatsklinikum FreiburgFreiburg, Germany, 79106 UniversitÃ¤tsmedizin GreifswaldGreifswald, Germany, 17475 UniversitÃ¤tsmedizin GÃ¶ttingenGÃ¶ttingen, Germany, 37099 Universitaetsklinik Hamburg-EppendorfHamburg, Germany, 20246 Asklepios Klinik AltonaHamburg, Germany, 22763 Medizinische Hochschule HannoverHannover, Germany, 30625 UniversitÃ¤tsklinikum Des SaarlandesHomburg/Saar, Germany, 66421 Universitaetsklinikum MuensterMuenster, Germany, 48149 Studienpraxis Urologie Drs. FeyerabendNuertingen, Germany, 72622 Kliniken Nordoberpfalz Ag/Klinikum WeidenWeiden, Germany, 92637|AchaÃ¯a, Greece, 26504 Errikos Dunant Hospital CenterAthens, Greece, 11526 University Of Athens Medical School - Regional General HospiAthina, Greece, 115 28 University Hospital Of HeraklionHeraklion, Greece, 71110 University Hospital Of LarissaLarisa, Greece, 41110 Interbalkan European Medical CenterThessaloniki, Greece, 14564 Euromedica General ClinicThessaloniki, Greece, 54645 University General Hospital Of ThessalonikiThessaloniki, Greece, 56403|Budapest, Hungary, 1082 Orszagos Onkologiai IntezetBudapest, Hungary, 1122 Uzsoki Utcai KorhazBudapest, Hungary, H-1145 Szabolcs-Szatmar-Bereg Megyei Korhazak Es Egyetemi OktatokorhazNyÃ­regyhÃ¡za, Hungary, 04400 Pecsi TudomanyegyetemPÃ©cs, Hungary, 7624|Bangalore, India, 560 017 Apollo Specialty HospitalChennai, India, 600035 Bhagwan Mahaveer Hospital & Research CentreJaipur, India, 302017 Sahyadri Speciality HospitalPune, India, 411001 Deenanath Mangeshkar Hospital And Research CentrePune, India, 411004|Haifa, Israel, 31096 Hadassah Medical CenterJerusalem, Israel, 91120 Meir Medical CenterKfar Saba, Israel, 44281 Rabin Medical Center, Beilinson HospitalPetach Tikvah, Israel, 49100 The Chaim Sheba Medical CenterTel Hashomer, Israel, 52621 Yitzhak Shamir Medical CenterZerifin, Israel, 70300|Alessandria, Italy, 15121 Ospedale S. Donato - Asl 8 ArezzoArezzo, Italy, 52100 Cro, Irccs, Istituto Nazionale TumoriAviano, Italy, 33081 Azienda Ospedaliera Papa Giovanni XxiiiBergamo, Italy, 24127 Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia Presidio Spedali CiviliBrescia, Italy, 25123 Istituti Ospitalieri Di Cremona, Ao Di CremonaCremona, Italy, 26100 Policlinico Hospital San Martino- Irccs For OncologyGenova, Italy, 16132 Irst Meldola - ForlÃ¬Meldola, Italy, 47014 Fondazione Irccs Istituto Nazionale Dei TumoriMilano, Italy, 20133 European Institute Of OncologyMilano, Italy, 20141 Aou Policlinico Di ModenaModena, Italy, 41124 Irccs-Fondazione PascaleNapoli, Italy, 80131 Ospedale Maggiore Della CaritÃ Novara, Italy, 28100 Aou San Luigi GonzagaOrbassano, Italy, 10043 Istituto Oncologico Veneto Iov Irccs PadovaPadova, Italy, 35128 Aou Di ParmaParma, Italy, 43126 Irccs Policlinico San MatteoPavia, Italy, 27100 Azienda Ospedaliero Universitaria PisanaPisa, Italy, 56126 Usl 7 Siena - Ospedale Alta Valdelsa Asl Toscana Sud-EstPoggibonsi (Si), Italy, 53100 Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria Alle ScotteSiena, Italy, 53100 Oncologia Medica-CittÃ  Della Salute E Della Scienza Di TorinoTorino, Italy, 10123 Azienda Ospedaliero - Universitaria Ospedali RiunitiTorrette Di Ancona, Italy, 60126|Hirosaki, Japan, 036-8563 National Cancer Center Hospital EastKashiwa, Japan, 277-8577 Kagawa University HospitalKita-Gun, Japan, 761-0793 Kobe City Medical Center General HospitalKobe, Japan, 650-0047 Dokkyo Medical University Koshigaya HospitalKoshigaya, Japan, 343-8555 National Shikoku Cancer CenterMatsuyama, Japan, 791-0280 University Of Miyazaki HospitalMiyazaki, Japan, 889-1692 Nagano Municipal HospitalNagano, Japan, 381-8551 Aichi Cancer Center HospitalNagoya-Shi, Japan, 464-8681 Kinki University HospitalOsaka-Sayama, Japan, 589-8511 Osaka Medical Center For Cancer And Cardiovascular DiseasesOsaka, Japan, 537-8511 Osaka City University HospitalOsaka, Japan, 545-8586 Kitasato University HospitalSagamihara, Japan, 252-0375 Toho University Sakura Medical CenterSakura, Japan, 285-8741 National Hospital, Hokkaido Cancer CenterSapporo, Japan, 003-0804 Tokyo Women'S Medical University HospitalShinjuku-Ku, Japan, 162-8666 Nippon Medical School HospitalTokyo, Japan, 113-8603 University Of Tsukuba HospitalTsukuba, Japan, 305-8576 Yamaguchi University HospitalUbe, Japan, 755-8505 Yokohama City University Medical CenterYokohama, Japan, 232-0024 Korea, Republic Of Pusan National University Hospital.Busan, Korea, Republic Of, 49241 Chungnam National University HospitalDaejeon, Korea, Republic Of, 35015 National Cancer CenterGoyangsi, Korea, Republic Of, 410-769 Gachon University Gil Medical CenterIncheon, Korea, Republic Of, 21565 Seoul National University Bundang HospitalSeongnam, Korea, Republic Of, 463-707 Korea University Anam HospitalSeoul, Korea, Republic Of, 02841 Seoul National University HospitalSeoul, Korea, Republic Of, 03080 Severance Hospital, Yonsei University Health SystemSeoul, Korea, Republic Of, 03722 Samsung Medical CenterSeoul, Korea, Republic Of, 135-710 Yonsei University Wonju Severance Christian HospitalWonju-Si, Korea, Republic Of, 26426|Aguascalientes, Mexico, 20230 Centro Estatal De CancerologÃ­a De ChihuahuaChihuahua, Mexico, 31000|Nijmegen, Netherlands, 6525 Ga|Lisboa, Portugal, 1500-458 H. Santa Maria - Centro Hospitalar De Lisboa NorteLisboa, Portugal, 1649-035 Hospital Santo Antonio Dos CapuchosLisboa, Portugal, G1R 2J6 Champalimaud Foundation Champalimaud CentreLisbon, Portugal, 1400-038 Instituto Portugues De OncologiaPorto, Portugal, 4200072 Russian Federation Altai Regional Oncology DispensaryBarnaul, Russian Federation, 656049 Chelyabinsk Regional Clinical Center Of Oncology And Nuclear MedicineChelyabinsk, Russian Federation, 454087 Ivanovo Regional Oncology DispensaryIvanovo, Russian Federation, 153040 Fsbsi 'N. N. Blokhin Russian Cancer Research Center'Moscow, Russian Federation, 115478 Russian Scientific Center Of RoentgenoradiologyMoscow, Russian Federation, 117997 Hertzen Oncology Research InstituteMoscow, Russian Federation, 125284 Privolzhsky District Medical Center Under The Federal Medico-Biological AgencyNizhni Novgorod, Russian Federation, 603109 National Medical Radiological Research CenterObninsk, Russian Federation, 249036 Clinical Oncology DispensaryOmsk, Russian Federation, 644013 Gbuz Of Stavropol Region Pyatigorsk Oncological DispensaryPyatigorsk, Russian Federation, 357502 City Polyprofiled Hospital #2Saint Petersburg, Russian Federation, 194354 Pavlov First Saint Petersburg State Medical UniversitySaint Petersburg, Russian Federation, 197022 Clinical Hopital N/A Petra VelikogoSaint-Petersburg, Russian Federation, 195067 National Research Mordovia State UniversitySaransk, Russian Federation, 430032 Saratov State Medical UniversitySaratov, Russian Federation, 410000 Russian Scientific Center Of Radiology And Surgical TechnologiesSt. Petersburg, Russian Federation, 197758 Northen-Western State Medical University N.A. I.I. MechnikovSt.Petersburg, Russian Federation, 191015 Llc BioeqSt.Petersburg, Russian Federation, 197342 Multifunctional Clinical Medical Center 'Medical City'Tyumen, Russian Federation, 625041|Badajoz, Spain, 06006 Institut CatalÃ  D'Oncologia-Hospital Universitari Germans Trias I PujolBadalona, Spain, 08916 Hosp. Clinic I Provincial De BarcelonaBarcelona, Spain, 08036 Hosp. De La Santa Creu I Sant PauBarcelona, Spain, 08041 Hosp. Reina SofiaCÃ³rdoba, Spain, 14004 Hosp. Univ. Virgen De Las NievesGranada, Spain, 18014 Complejo Hospitalario De JaenJaÃ©n, Spain, 23007 Hosp. Univ. Lucus AugustiLugo, Spain, 27003 Hosp. Gral. Univ. Gregorio MaraÃ±onMadrid, Spain, 28009 Centro Oncologico Md AndersonMadrid, Spain, 28033 Hosp. Univ. La PazMadrid, Spain, 28046 Hosp. Univ. Pta. De Hierro MajadahondaMajadahonda, Spain, 28220 Althaia, Xarxa Assistencial UniversitÃ ria De ManresaManresa, Spain, 08243 Hosp. Virgen De La VictoriaMÃ¡laga, Spain, 29010 Hosp. De NavarraPamplona, Spain, 31008 Hosp. Virgen MacarenaSevilla, Spain, 41009 Hosp. Virgen Del RocioSevilla, Spain, 41013 Hosp. Univ. I Politecni La FeValencia, Spain, 46026 Hosp. Univ. Miguel ServetZaragoza, Spain, 50009 Taiwan Kaohsiung Medical University Chung-Ho Memorial HospitalKaohsiung, Taiwan, 807 Chi Mei Medical Center - Liu YingLiou Ying Township, Taiwan, 736 Chang Gung Medical FoundationNiao-Sung Hsiang, Taiwan, 833 Taichung Veterans General HospitalTaichung, Taiwan, 40705 National Cheng Kung University HospitalTainan, Taiwan, 70403 National Taiwan University HospitalTaipei City, Taiwan, 10002 Mackay Memorial HospitalTaipei, Taiwan, 10449 Taipei Veterans General HospitalTaipei, Taiwan, 11217 Koo Foundation Sun Yat-Sen Cancer CenterTaipei, Taiwan, 11259 Chang-Gung Memorial Hospital, Linkou BranchTaoyuan, Taiwan, 333|Adana, Turkey, 01120 Hacettepe University Medical FacultyAnkara, Turkey, 6100 Bezmialem University Medical FacultyIstanbul, Turkey, 34093 Medipol Mega University HospitalIstanbul, Turkey, 34214 Marmara University Medical FacultyIstanbul, Turkey, 34890 Istanbul Medeniyet University Goztepe Training And Research HospitalIstanbul, Turkey, 81450 Ege UniversityIzmir, Turkey, 35100 Dokuz Eylul Universitesi Tip FakultesiIzmir, Turkey, 35340 Kocaeli University Medical FacultyKocaeli, Turkey Inonu Universitesi Turgut Ozal Tip Merkezi, Ic HastaliklariMalatya, Turkey, 44400|Chernivtsi, Ukraine, 58002 Mi Dnipropetrovsk Region Clinical Hospital N A I.I.MechnikovDnipropetrovsk, Ukraine, 49005 Komunalnyi Zaklad Miska Bahatoprofilna Klinichna Likarnia #4Dnipropetrovsk, Ukraine, 49102 Regional Oncological DispanseryDnipro, Ukraine, 49100 Oblasna Klinichna Likarnia - Urolohichne ViddilenniaIvano-Frankivsk, Ukraine, 76018 Regional Center Of OncologyKharkov, Ukraine, 61070 National Cancer InstituteKyiv, Ukraine, 03022 Transkarpathian Regional University Oncology ClinicUzhgorod, Ukraine, 88000 Vinnytskyi Oblasnyi Klinichnyi Onkolohichnyi Dyspanser, Viddilennia KhimioterapiiVinnytsia, Ukraine, 21029 ZaokodZaporizhzhia, Ukraine, 69040 Zaporizhzhia Medical Academy Of Postgraduate Education, Zaporizhzhia Regoinal Clinical HospitalZaporizhzhia, Ukraine, 69600|Bristol, United Kingdom, Bs2 8Ed Gloucestershire Hospitals Nhs Foundation Trust - CheltenhamCheltenham, United Kingdom, Gl53 7An Sarah Cannon Research InstituteLondon, United Kingdom, W1G 6Ad Charing Cross HospitalLondon, United Kingdom, W6 8Rf The Christie Nhs Foundation Trust - Christie HospitalManchester, United Kingdom, M20 4Bx Derriford Hospital-Department Of Medical OncologyPlymouth, United Kingdom, Pl6 8Qh Southampton General HospitalSouthampton, United Kingdom, So16 6Yd Royal Marsden HospitalSutton, United Kingdom, Sm2 5Ng Clatterbridge Centre For OncologyWirral, United Kingdom, Ch63 4Jy New Cross HospitalWolverhampton, United Kingdom, Wv10 0Qp|Anchorage, Alaska, United States, 99503|Phoenix, Arizona, United States, 85004|Saint Helena, California, United States, 94574 Kaiser Permanente Medical CenterVallejo, California, United States, 95119|Aurora, Colorado, United States, 80045 United States, District Of Columbia Medstar Georgetown University HospitalWashington, District Of Columbia, United States, 20007|Miami, Florida, United States, 33136 Mid-Florida Hematology OncologyOrange, Florida, United States, 32763|Atlanta, Georgia, United States, 30318-0922|Chicago, Illinois, United States, 60612|Louisville, Kentucky, United States, 40202|Ann Arbor, Michigan, United States, 48109-5000|Bronx, New York, United States, 10461 Weill Cornell Medical CollegeNew York, New York, United States, 10029|Charlotte, North Carolina, United States, 28204 Duke UniversityDurham, North Carolina, United States, 27701 Wake Forest University - Baptist Medical CenterWinston-Salem, North Carolina, United States, 27157|Hershey, Pennsylvania, United States, 17033|Columbia, South Carolina, United States, 65212-1000|Fort Worth, Texas, United States, 76104 Md Anderson Cancer CenterHouston, Texas, United States, 77030","Alaska|Arizona|California|Colorado|Florida|Georgia|Illinois|Kentucky|Michigan|New York|North Carolina|Pennsylvania|South Carolina|Texas","Australia|Austria|Belgium|Brazil|Canada|China|France|Germany|Greece|Hungary|India|Israel|Italy|Japan|Mexico|Netherlands|Portugal|Spain|Turkey|Ukraine|United Kingdom|United States","Chris O'Brien Lifehouse|Lkh-Univ. Klinikum Graz|Olv Ziekenhuis Aalst|Fundacao Pio Xii - Hospital De Cancer De Barretos|British Columbia Vancouver Cancer Centre|Manitoba Cancercare Manitoba|Peking University First Hospital|Institut De CancÃ©rologie De L'Ouest (Ico)|Vivantes Klinikum Am Urban|University General Hospital Of Rio Patras|Semmelweis Egyetem|Manipal Comprehensive Cancer Centre, Manipal Hospital|Rambam Health Care Campus|Azienda Ospedaliera Nazionale Ss. Antonio E Biagio E Cesare Arrigo Alessandria|Hirosaki University School Of Medicine & Hospital|San Peregrino Cancer Center|Radboud Umcn|Hospital LusÃ­adas|Hosp. Univ. Infanta Cristina|Adana Baskent Practice And Research Hospital|Chernivtsi Regional Clinical Hospital|University Hospitals Bristol - Bristol Haematology & Oncolog|Alaska Urological Institute Dba Alaska Clinical Research Center|University Of Ua Cancer Center(Uacc)/Dh-Sjhmc|St. Helena Hospital - Martin-O'Neil Cancer Center|Uchealth Anschutz Cancer Pavilion|University Of Miami/Sylvester Cancer Center|Piedmont Cancer Institute|Northwestern University|Norton Cancer Institute|University Of Michigan Health System|Montefiore Medical Center|Levine Cancer Institute, Carolinas Healthcare System|Penn State Hershey Cancer Institute|University Of Missouri|The Center For Cancer And Blood Disorders",{"$nulls":3},"Janssen Research & Development, LLC Clinical Trials","2018-05-01","2020-05-25T16:35:11.913","2020-05-26T17:10:42.972","NCT03390504"]
["5ecbf3bf307e3d1b1f8d9c2c","NCT03390504","2018-06-01","Johnson & Johnson","JNJ","Recruiting","A Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Participants With Advanced Urothelial Cancer and Selected Fibroblast Growth Factor Receptor (FGFR) Gene Aberrations","Erdafitinib|Fibroblast|Vinflunine|Docetaxel|Pembrolizumab","FGFR Antagonist|Tubulin Inhibitor|Mitosis Inhibitor|Tubulin Inhibitor|PD-1 Inhibitor","Yes","['Erdafitinib', 'Fibroblast', 'Vinflunine']","No",null,"Phase 3",4,631,"Anticipated","2018-03-23","2020-11-24","OS","Overall Survival",{"$nulls":3},"The purpose of this study is to evaluate efficacy of erdafitinib versus chemotherapy or pembrolizumab in participants with advanced urothelial cancer harboring selected fibroblast growth factor receptor (FGFR) aberrations who have progressed after one prior treatment.","A study of erdafitinib versus standard of care, consisting of chemotherapy (docetaxel or vinflunine) or PD1 agent pembrolizumab, in participants with advanced urothelial cancer and selected FGFR aberrations who have progressed on or after one prior line of systemic therapy. It will consist of screening, treatment phase (from randomization until disease progression, intolerable toxicity, withdrawal of consent or decision by investigator to discontinue treatment else participants will discontinue treatment after completion of 2 years pembrolizumab therapy), post-treatment follow-up (from end-of-treatment to participants death, withdraws consent, lost to follow-up, or end of study, whichever comes first). Efficacy, pharmacokinetics, biomarkers, patient reported outcomes, medical resource utilization and safety will be assessed.","A Phase 3 Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Subjects With Advanced Urothelial Cancer and Selected FGFR Gene Aberrations","CR108401","Urothelial Cancer","Transitional Cell Carcinoma","Oncology Solid Tumor","Oncology","Experimental","Cohort 1 (Arm 1A): Erdafitinib|Cohort 1 (Arm 1B): Vinflunine or Docetaxel|Cohort 2 (Arm 2A): Erdafitinib|Cohort 2 (Arm 2B): Pembrolizumab","Participants will be screened based on Fibroblast Growth Factor Receptor inhibitor Clinical Trial Assay (FGFRi CTA) to determine molecular eligibility and participants who meet molecular eligibility criteria will be enrolled. Participants (treated with prior anti-anti-programmed cell death protein [PD][L]1 agent) will swallow erdafitinib tablets orally at a starting dose of 8 milligram (mg), once daily for 21 days in a 21-day cycle until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustment are based on phosphate level and observed toxicity (adverse events [AEs]).|Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be enrolled. Participants (treated with prior anti-PD[L]1 agent) will receive vinflunine 320 milligram per meter square (mg/m^2) as a 20-minute intravenous infusion once every 3 weeks or docetaxel 75 mg/m^2 as a 1 hour intravenous infusion every 3 weeks. Treatment with either agent (choice of investigator) will be administered until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustments are based on observed toxicities.|Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be enrolled. Participants (no prior treatment with anti-PD(L)1 agent) will swallow erdafitinib tablets orally at a starting dose of 8 mg, once daily for 21 days in a 21-day cycle until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustments are based on phosphate level and observed toxicity (AEs).|Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be enrolled. Participants (no prior treatment with anti-PD(L)1 agent) will receive pembrolizumab 200 mg as a 30-minute intravenous infusion once every 3 weeks, until disease progression, intolerable toxicity, withdrawal of consent, decision by the investigator to discontinue treatment or the completion of 2 years of pembrolizumab therapy. Dose adjustments are based on observed toxicities.","Drug|Device","Erdafitinib|Fibroblast Growth Factor Receptor inhibitor Clinical Trial Assay (FGFRi CTA)|Vinflunine|Docetaxel|Pembrolizumab","Participants will swallow erdafitinib tablets orally at a starting dose of 8 mg.|FGFRi CTA will be used to determine molecular eligibility.|Participants will receive vinflunine 320 mg/m^2 as a 20-minute intravenous infusion.|Participants will receive docetaxel 75 mg/m^2 as a 1 hour intravenous infusion.|Participants will receive pembrolizumab 200 mg as a 30-minute intravenous infusion.","JNJ-42756493","Cohort 1 (Arm 1A): Erdafitinib|Cohort 1 (Arm 1B): Vinflunine or Docetaxel|Cohort 2 (Arm 2A): Erdafitinib|Cohort 2 (Arm 2B): Pembrolizumab","\n\n * Histologic demonstration of transitional cell carcinoma of the urothelium. Minor components ( less than [<] 50 percent [%] overall) of variant histology such as glandular or squamous differentiation, or evolution to more aggressive phenotypes such as sarcomatoid or micropapillary change are acceptable\n * Stage IV disease (metastatic or surgically unresectable, cT4b, N+, or M+ cancer)\n * Documented progression of disease, defined as any progression that requires a change in treatment, prior to randomization\n * Only one line of prior systemic treatment for metastatic urothelial cancer. Participants who received neoadjuvant or adjuvant chemotherapy and showed disease progression (as defined above), within 12 months of the last dose are considered to have received systemic chemotherapy in the metastatic setting Cohort 1: prior chemotherapy and anti-PD(L)1 [in combination or in maintenance setting] (anti-PD(L)1 alone is allowed only for participants with documented cisplatin ineligibility) and Cohort 2: prior chemotherapy (no prior anti-PD(L)1 treatment)\n * A woman of childbearing potential who is sexually active must have a negative pregnancy test (beta human chorionic gonadotropin [beta hCG]) at Screening (urine or serum)\n * Participants must meet appropriate molecular eligibility criteria\n * Eastern Cooperative Oncology Group (ECOG) performance status Grade 0, 1, or 2\n * Adequate bone marrow, liver, and renal function\n\n","\n\n * Treatment with any other investigational agent or participation in another clinical study with therapeutic intent within 30 days prior to randomization\n * Active malignancies (that is, requiring treatment change in the last 24 months) other than urothelial cancer (except skin cancers within the last 24 months that is considered completely cured)\n * Symptomatic central nervous system metastases\n * Received prior fibroblast growth factor receptor (FGFR) inhibitor treatment\n * Known allergies, hypersensitivity, or intolerance to erdafitinib or its excipients\n * Corneal or retinal abnormality likely to increase the risk of eye toxicity\n * History of uncontrolled cardiovascular disease including\n * Impaired wound healing capacity defined as skin/decubitus ulcers, chronic leg ulcers, known gastric ulcers, or unhealed incisions",{"$nulls":4},"Actual","2018-01-04","Actual","Anticipated","2021-05-27","Anticipated","2018-05-01","2017-12-20","2018-01-03","2018-05-31","Yes",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No",null,null,"URL: http://pam.sylogent.com/cr/CR108401 [http://pam.sylogent.com/cr/CR108401] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To learn how to participate in this trial please click here.",null,"Yes","Yes",{"$nulls":17},"2017-002932-18|42756493BLC3001","EudraCT Number|Janssen Research & Development, LLC","Overall Survival (OS)","Overall survival is measured from the date of randomization to the date of the participant's death. If the participant is alive or the vital status is unknown, the participant will be censored at the date the participant was last known to be alive.","Date of first randomization to the date of participant's death (approximately up to 3 years)","Progression-free Survival (PFS)|Overall Response Rate (ORR)|Time to Worsening in Symptom Items and Functioning Subscales in Patient-Reported Health Status of the Functional Assessment of Cancer Therapy-Bladder Cancer (FACT-Bl)|Change from Baseline in Patient-Global Impression of Severity (PGIS) Score|Change from Baseline in the Visual Analog Scale (VAS) of the EQ-5D-5L|Change from Baseline in the Utility Scale of the EQ-5D-5L|Duration of Response (DOR)|Number of Participants with Adverse Events (AEs) as a Measure of Safety|Oral Clearance (CL/F) of Erdafitinib|Area Under the Plasma Concentration-Time Curve from Time Zero to Time 't' (AUC[0-t]) of Erdafitinib","PFS is defined as duration in days from date of randomization to disease progression date (assessed per Response Evaluation Criteria in Solid Tumors Version 1.1|ORR is defined as the proportion of participants who achieve CR (CR; disappearance of all target lesions and disappearance of all non-target lesions and normalization of tumor marker level) or partial response (PR; at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters), as assessed per RECIST v1.1 by the investigator.|The FACT-Bl consists of 36 core items, with 5-point Likert response scales, covering 5 primary domains: Physical well-being, social/family well-being, emotional well-being, functional well-being and bladder symptom subscale. The answer scales range from \"Not at all (score=0)\" to \"very much (score=4)\" to assess the meaningful significant symptom deterioration.|The PGIS is a single question regarding the participant report of disease severity. Participants will be asked that ''considering all aspects of your bladder cancer symptoms right now, would you say your bladder cancer symptoms are none, mild, moderate, severe, or very severe?\" The PGIS is an anchor question that will be used to establish the magnitude of meaningful change in this study by assessing disease severity.|European Quality of Life 5 Dimensions (EQ-5D) visual analog scale (VAS) is a 20 centimeter (cm) vertical VAS with scores ranging from 0 (worst imaginable health) to 100 (perfect health). A higher score indicates an improvement in health in the Health Status Index.|The EuroQol-5 is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating \"full health\" and 0 representing dead.|DOR for responders is defined as duration in days from the date of initial documentation of a response to the date of first documented evidence of progressive disease (PD) or relapse for participants who experience CR (CR; disappearance of all target lesions and disappearance of all non-target lesions and normalization of tumor marker level) during the study or death.|An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.|CL/F is the oral clearance; that is clearance based on oral bioavailability of erdafitinib.|AUC(0-t) is the area under the plasma concentration-time curve from time zero to any time 't' of erdafitinib.","RECIST v1.1 by investigator) or relapse from CR or death, whichever is reported first. RECIST 1.1, progressive disease is defined as a 20 percent (%) increase in the sum of diameters of all target lesions and a minimum absolute increase of 5 millimeter (mm) in the sum. CR is defined as disappearance of all target lesions, non-target lesions and normalization of tumor marker level.|Approximately up to 3 years|Baseline up to end of treatment (approximately 3 years)|Baseline up to follow up phase (approximately 3 years)|From the date of initial documentation of a response to date of first documented evidence of progressive disease (or participants relapse who experience CR during the study) or death (approximately up to 3 years)|Day 14 (Cycle 1), Day 1 (Cycle 2) (each cycle is of 21 days)","JNJ.CT@sylogent.com","Study Contact","844-434-4210","Camperdown, Australia, 2050 Peninsula & South Eastern Haematology And Oncology GroupFrankston, Australia, 3199 Royal Hobart HospitalHobart, Australia, 7000 Peter Maccallum Cancer CentreMelbourne, Australia, 3000 Frankston HospitalMelbourne, Australia, 3199 Southside Cancer Care CentreMiranda, Australia, 2228 Sir Charles Gairdner HospitalNedlands, Australia, 6009|Graz, Austria, 8036 Krankenhaus Der Barmherzigen SchwesternLinz, Austria, 4010 Lkh - UniversitÃ¤tsklinikum Der Pmu SalzburgSalzburg, Austria, 5020 Medical University Vienna, MuvVienna, Austria, A-1090|Aalst, Belgium, 9300 Zna MiddelheimAntwerpen, Belgium, 2020 Cliniques Universitaires Saint-LucBrussel, Belgium, 1200 Clinique Notre Dame De GrÃ¢ceCharleroi, Belgium, 6000 Az Maria MiddelaresGent, Belgium, 9000 Universitair Ziekenhuis GentGent, Belgium, 9000 Chc-Cliniques Saint-JosephLiÃ¨ge, Belgium, 4000 Sint-Augustinus AzWilrijk, Belgium, 2610 Chu Dinant Godinne Ucl NamurYvoir, Belgium, 5530|Barretos, Brazil, 14784-400 AssociaÃ§Ã£o MÃ¡rio Penna\\NÃºcleo De Ensino E PesquisasBelo Horizonte, Brazil, 30380-472 Hospital Erasto GaertnerCuritiba, Brazil, 81520-060 ClÃ­nica De Neoplasias Litoral Ltda.Itajai, Brazil, 88301-220 Upco - HcpaPorto Alegre, Brazil, 90035-903 Inca - Instituto Nacional Do CancerRio De Janeiro, Brazil, 20231-050 Fundacao Antonio PrudenteSao Paulo, Brazil, 01509900 Hospital De Base De SÃ£o JosÃ© Do Rio PretoSÃ£o JosÃ© Do Rio Preto, Brazil, 15090-000 Sociedade Beneficiante De Senhoras - Hospital Sirio LibanesSÃ£o Paulo, Brazil, 01308901 Cepho - Faculdade De Medicina Do AbcSÃ£o Paulo, Brazil, 09060-650|Kelowna, British Columbia, Canada, V1Y 5L3 Vancouver Cancer CentreVancouver, British Columbia, Canada, V5Z 4E6|Winnipeg, Manitoba, Canada, R3E 0V9|Beijing, China, 100034 Beijing Friendship HospitalBeijing, China, 100050 Peking University Third HospitalBeijing, China, 100191 Beijing HospitalBeijing, China, 100730 Peking Union Medical College HospitalBeijing, China, 100730 Sichuan Provincial People'S HospitalChengdu, China, 610000 Sun Yat-Sen Memorial Hospital, Sun Yat-Sen UniversityGuangzhou, China, 510120 Guangzhou First Municipal People'S HospitalGuangzhou, China, 510180 Zhejiang Provincial People'S HospitalHangzhou, China, 310000 Sir Run Run Shaw Hospital, Zhejiang UniversityHangzhou, China, 310016 The First Affliated Hospital Of Nanchang UniversityNanchang, China, 330006 Nanjing Drum Tower HospitalNanjing, China, 210008 Jiangsu Cancer HospitalNanjing, China, 210009 Renji Hospital, Shanghai Jiaotong University School Of MedicineShanghai, China, 200127 Huadong Hospital Affiliated To Fudan UniversityShanghai, China, 200400 First Affiliated Hospital, Xi'An Jiaotong UniversityXi'An, China, 710061|Angers, France, 49055 Hopital Jean MinjozBesancon Cedex, France, 25030 Institut BergoniÃ©Bordeaux, France, 33000 Centre Jean PerrinClermont Ferrand, France, 63011 Hopital Henri MondorCreteil, France, 94010 Centre Georges-FranÃ§ois LeclercDijon, France, 21079 Centre Oscar LambretLille, France, 59020 Centre Leon BÃ©rardLyon, France, 69008 Hopital De La TimoneMarseille, France, 13005 Institut Regional Du Cancer De Montpellier Val D'AurelleMontpellier, France, 34298 Centre Antoine LacassagneNice, France, 06189 Institut De CancÃ©rologie Du GardNÃ®mes, France, 30029 Hopital Europeen Georges-PompidouParis, France, 75015 Hospices Civils De Lyon HclPierre-BÃ©nite, France, 69495 Chu De PoitiersPoitiers Cedex, France, 86021 Centre Hopitalier Inter-Communal De CornouailleQuimper, France, 2900 Centre Eugene MarquisRennes Cedex, France, 35062 I.C.O. RenÃ© GauducheauSaint Herblain Cedex, France, 44805 Institut De CancÃ©rologie De LoireSaint-Priest-En-Jarez, France, 42271 Hopitaux Universitaires De StrasbourgStrasbourg, France, 67091 Institut Claudius RegaudToulouse, France, 31059 Institut Gustave RoussyVillejuif, France, 94805|Berlin, Germany, 10967 Universitatsklinikum Carl Gustav Carcus DresdenDresden, Germany, 01307 Universitaetsklinikum DuesseldorfDuesseldorf, Germany, 40225 Friedrich-Alexander Universitaet Urologische UniversitaetsklErlangen, Germany, 91054 Universitatsklinikum FreiburgFreiburg, Germany, 79106 UniversitÃ¤tsmedizin GreifswaldGreifswald, Germany, 17475 UniversitÃ¤tsmedizin GÃ¶ttingenGÃ¶ttingen, Germany, 37099 Universitaetsklinik Hamburg-EppendorfHamburg, Germany, 20246 Asklepios Klinik AltonaHamburg, Germany, 22763 Medizinische Hochschule HannoverHannover, Germany, 30625 UniversitÃ¤tsklinikum Des SaarlandesHomburg/Saar, Germany, 66421 Universitaetsklinikum MuensterMuenster, Germany, 48149 Studienpraxis Urologie Drs. FeyerabendNuertingen, Germany, 72622 Kliniken Nordoberpfalz Ag/Klinikum WeidenWeiden, Germany, 92637|AchaÃ¯a, Greece, 26504 Errikos Dunant Hospital CenterAthens, Greece, 11526 University Of Athens Medical School - Regional General HospiAthina, Greece, 115 28 University Hospital Of HeraklionHeraklion, Greece, 71110 University Hospital Of LarissaLarisa, Greece, 41110 Interbalkan European Medical CenterThessaloniki, Greece, 14564 Euromedica General ClinicThessaloniki, Greece, 54645 University General Hospital Of ThessalonikiThessaloniki, Greece, 56403|Budapest, Hungary, 1082 Orszagos Onkologiai IntezetBudapest, Hungary, 1122 Uzsoki Utcai KorhazBudapest, Hungary, H-1145 Szabolcs-Szatmar-Bereg Megyei Korhazak Es Egyetemi OktatokorhazNyÃ­regyhÃ¡za, Hungary, 04400 Pecsi TudomanyegyetemPÃ©cs, Hungary, 7624|Bangalore, India, 560 017 Apollo Specialty HospitalChennai, India, 600035 Bhagwan Mahaveer Hospital & Research CentreJaipur, India, 302017 Sahyadri Speciality HospitalPune, India, 411001 Deenanath Mangeshkar Hospital And Research CentrePune, India, 411004|Haifa, Israel, 31096 Hadassah Medical CenterJerusalem, Israel, 91120 Meir Medical CenterKfar Saba, Israel, 44281 Rabin Medical Center, Beilinson HospitalPetach Tikvah, Israel, 49100 The Chaim Sheba Medical CenterTel Hashomer, Israel, 52621 Yitzhak Shamir Medical CenterZerifin, Israel, 70300|Alessandria, Italy, 15121 Ospedale S. Donato - Asl 8 ArezzoArezzo, Italy, 52100 Cro, Irccs, Istituto Nazionale TumoriAviano, Italy, 33081 Azienda Ospedaliera Papa Giovanni XxiiiBergamo, Italy, 24127 Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia Presidio Spedali CiviliBrescia, Italy, 25123 Istituti Ospitalieri Di Cremona, Ao Di CremonaCremona, Italy, 26100 Oncologia MedicaFirenze, Italy, 50139 Policlinico Hospital San Martino- Irccs For OncologyGenova, Italy, 16132 Irst Meldola - ForlÃ¬Meldola, Italy, 47014 Fondazione Irccs Istituto Nazionale Dei TumoriMilano, Italy, 20133 European Institute Of OncologyMilano, Italy, 20141 Aou Policlinico Di ModenaModena, Italy, 41124 Irccs-Fondazione PascaleNapoli, Italy, 80131 Ospedale Maggiore Della CaritÃ Novara, Italy, 28100 Aou San Luigi GonzagaOrbassano, Italy, 10043 Istituto Oncologico Veneto Iov Irccs PadovaPadova, Italy, 35128 Aou Di ParmaParma, Italy, 43126 Irccs Policlinico San MatteoPavia, Italy, 27100 Azienda Ospedaliero Universitaria PisanaPisa, Italy, 56126 Usl 7 Siena - Ospedale Alta Valdelsa Asl Toscana Sud-EstPoggibonsi (Si), Italy, 53100 Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria Alle ScotteSiena, Italy, 53100 Oncologia Medica-CittÃ  Della Salute E Della Scienza Di TorinoTorino, Italy, 10123 Azienda Ospedaliero - Universitaria Ospedali RiunitiTorrette Di Ancona, Italy, 60126|Hirosaki, Japan, 036-8563 National Cancer Center Hospital EastKashiwa, Japan, 277-8577 Kagawa University HospitalKita-Gun, Japan, 761-0793 Kobe City Medical Center General HospitalKobe, Japan, 650-0047 Dokkyo Medical University Koshigaya HospitalKoshigaya, Japan, 343-8555 National Shikoku Cancer CenterMatsuyama, Japan, 791-0280 University Of Miyazaki HospitalMiyazaki, Japan, 889-1692 Nagano Municipal HospitalNagano, Japan, 381-8551 Aichi Cancer Center HospitalNagoya-Shi, Japan, 464-8681 Kinki University HospitalOsaka-Sayama, Japan, 589-8511 Osaka Medical Center For Cancer And Cardiovascular DiseasesOsaka, Japan, 537-8511 Osaka City University HospitalOsaka, Japan, 545-8586 Kitasato University HospitalSagamihara, Japan, 252-0375 Toho University Sakura Medical CenterSakura, Japan, 285-8741 National Hospital, Hokkaido Cancer CenterSapporo, Japan, 003-0804 Tokyo Women'S Medical University HospitalShinjuku-Ku, Japan, 162-8666 Nippon Medical School HospitalTokyo, Japan, 113-8603 University Of Tsukuba HospitalTsukuba, Japan, 305-8576 Yamaguchi University HospitalUbe, Japan, 755-8505 Yokohama City University Medical CenterYokohama, Japan, 232-0024 Korea, Republic Of Pusan National University Hospital.Busan, Korea, Republic Of, 49241 Chungnam National University HospitalDaejeon, Korea, Republic Of, 35015 National Cancer CenterGoyangsi, Korea, Republic Of, 410-769 Gachon University Gil Medical CenterIncheon, Korea, Republic Of, 21565 Seoul National University Bundang HospitalSeongnam, Korea, Republic Of, 463-707 Korea University Anam HospitalSeoul, Korea, Republic Of, 02841 Seoul National University HospitalSeoul, Korea, Republic Of, 03080 Severance Hospital, Yonsei University Health SystemSeoul, Korea, Republic Of, 03722 Samsung Medical CenterSeoul, Korea, Republic Of, 135-710 Yonsei University Wonju Severance Christian HospitalWonju-Si, Korea, Republic Of, 26426|Aguascalientes, Mexico, 20230 Centro Estatal De CancerologÃ­a De ChihuahuaChihuahua, Mexico, 31000|Nieuwegein, Netherlands, 3430 Em Radboud UmcnNijmegen, Netherlands, 6525 Ga|Lisboa, Portugal, 1500-458 H. Santa Maria - Centro Hospitalar De Lisboa NorteLisboa, Portugal, 1649-035 Hospital Santo Antonio Dos CapuchosLisboa, Portugal, G1R 2J6 Champalimaud Foundation Champalimaud CentreLisbon, Portugal, 1400-038 Instituto Portugues De OncologiaPorto, Portugal, 4200072 Russian Federation Altai Regional Oncology DispensaryBarnaul, Russian Federation, 656049 Chelyabinsk Regional Clinical Center Of Oncology And Nuclear MedicineChelyabinsk, Russian Federation, 454087 Ivanovo Regional Oncology DispensaryIvanovo, Russian Federation, 153040 Fsbsi 'N. N. Blokhin Russian Cancer Research Center'Moscow, Russian Federation, 115478 Russian Scientific Center Of RoentgenoradiologyMoscow, Russian Federation, 117997 Hertzen Oncology Research InstituteMoscow, Russian Federation, 125284 Privolzhsky District Medical Center Under The Federal Medico-Biological AgencyNizhni Novgorod, Russian Federation, 603109 National Medical Radiological Research CenterObninsk, Russian Federation, 249036 Clinical Oncology DispensaryOmsk, Russian Federation, 644013 Gbuz Of Stavropol Region Pyatigorsk Oncological DispensaryPyatigorsk, Russian Federation, 357502 City Polyprofiled Hospital #2Saint Petersburg, Russian Federation, 194354 Pavlov First Saint Petersburg State Medical UniversitySaint Petersburg, Russian Federation, 197022 Clinical Hopital N/A Petra VelikogoSaint-Petersburg, Russian Federation, 195067 National Research Mordovia State UniversitySaransk, Russian Federation, 430032 Saratov State Medical UniversitySaratov, Russian Federation, 410000 Russian Scientific Center Of Radiology And Surgical TechnologiesSt. Petersburg, Russian Federation, 197758 Northen-Western State Medical University N.A. I.I. MechnikovSt.Petersburg, Russian Federation, 191015 Llc BioeqSt.Petersburg, Russian Federation, 197342 Multifunctional Clinical Medical Center 'Medical City'Tyumen, Russian Federation, 625041|Badajoz, Spain, 06006 Institut CatalÃ  D'Oncologia-Hospital Universitari Germans Trias I PujolBadalona, Spain, 08916 Hosp. Clinic I Provincial De BarcelonaBarcelona, Spain, 08036 Hosp. De La Santa Creu I Sant PauBarcelona, Spain, 08041 Hosp. Reina SofiaCÃ³rdoba, Spain, 14004 Hosp. Univ. Virgen De Las NievesGranada, Spain, 18014 Complejo Hospitalario De JaenJaÃ©n, Spain, 23007 Hosp. Univ. Lucus AugustiLugo, Spain, 27003 Hosp. Gral. Univ. Gregorio MaraÃ±onMadrid, Spain, 28009 Centro Oncologico Md AndersonMadrid, Spain, 28033 Hosp. Univ. La PazMadrid, Spain, 28046 Hosp. Univ. Pta. De Hierro MajadahondaMajadahonda, Spain, 28220 Althaia, Xarxa Assistencial UniversitÃ ria De ManresaManresa, Spain, 08243 Hosp. Virgen De La VictoriaMÃ¡laga, Spain, 29010 Hosp. De NavarraPamplona, Spain, 31008 Hosp. Virgen MacarenaSevilla, Spain, 41009 Hosp. Virgen Del RocioSevilla, Spain, 41013 Hosp. Univ. I Politecni La FeValencia, Spain, 46026 Hosp. Univ. Miguel ServetZaragoza, Spain, 50009 Taiwan Kaohsiung Medical University Chung-Ho Memorial HospitalKaohsiung, Taiwan, 807 Chi Mei Medical Center - Liu YingLiou Ying Township, Taiwan, 736 Chang Gung Medical FoundationNiao-Sung Hsiang, Taiwan, 833 Taichung Veterans General HospitalTaichung, Taiwan, 40705 National Cheng Kung University HospitalTainan, Taiwan, 70403 National Taiwan University HospitalTaipei City, Taiwan, 10002 Mackay Memorial HospitalTaipei, Taiwan, 10449 Taipei Veterans General HospitalTaipei, Taiwan, 11217 Koo Foundation Sun Yat-Sen Cancer CenterTaipei, Taiwan, 11259 Chang-Gung Memorial Hospital, Linkou BranchTaoyuan, Taiwan, 333|Adana, Turkey, 01120 Hacettepe University Medical FacultyAnkara, Turkey, 6100 Bezmialem University Medical FacultyIstanbul, Turkey, 34093 Medipol Mega University HospitalIstanbul, Turkey, 34214 Marmara University Medical FacultyIstanbul, Turkey, 34890 Istanbul Medeniyet University Goztepe Training And Research HospitalIstanbul, Turkey, 81450 Ege UniversityIzmir, Turkey, 35100 Dokuz Eylul Universitesi Tip FakultesiIzmir, Turkey, 35340 Kocaeli University Medical FacultyKocaeli, Turkey Inonu Universitesi Turgut Ozal Tip Merkezi, Ic HastaliklariMalatya, Turkey, 44400|Chernivtsi, Ukraine, 58002 Mi Dnipropetrovsk Region Clinical Hospital N A I.I.MechnikovDnipropetrovsk, Ukraine, 49005 Komunalnyi Zaklad Miska Bahatoprofilna Klinichna Likarnia #4Dnipropetrovsk, Ukraine, 49102 Regional Oncological DispanseryDnipro, Ukraine, 49100 Oblasna Klinichna Likarnia - Urolohichne ViddilenniaIvano-Frankivsk, Ukraine, 76018 Regional Center Of OncologyKharkov, Ukraine, 61070 National Cancer InstituteKyiv, Ukraine, 03022 Transkarpathian Regional University Oncology ClinicUzhgorod, Ukraine, 88000 Vinnytskyi Oblasnyi Klinichnyi Onkolohichnyi Dyspanser, Viddilennia KhimioterapiiVinnytsia, Ukraine, 21029 ZaokodZaporizhzhia, Ukraine, 69040 Zaporizhzhia Medical Academy Of Postgraduate Education, Zaporizhzhia Regoinal Clinical HospitalZaporizhzhia, Ukraine, 69600|Bristol, United Kingdom, Bs2 8Ed Gloucestershire Hospitals Nhs Foundation Trust - CheltenhamCheltenham, United Kingdom, Gl53 7An Sarah Cannon Research InstituteLondon, United Kingdom, W1G 6Ad Charing Cross HospitalLondon, United Kingdom, W6 8Rf The Christie Nhs Foundation Trust - Christie HospitalManchester, United Kingdom, M20 4Bx Derriford Hospital-Department Of Medical OncologyPlymouth, United Kingdom, Pl6 8Qh Southampton General HospitalSouthampton, United Kingdom, So16 6Yd Royal Marsden HospitalSutton, United Kingdom, Sm2 5Ng Clatterbridge Centre For OncologyWirral, United Kingdom, Ch63 4Jy New Cross HospitalWolverhampton, United Kingdom, Wv10 0Qp|Anchorage, Alaska, United States, 99503|Phoenix, Arizona, United States, 85004|Sacramento, California, United States, 95817 St. Helena Hospital - Martin-O'Neil Cancer CenterSaint Helena, California, United States, 94574 Kaiser Permanente Medical CenterVallejo, California, United States, 95119|Aurora, Colorado, United States, 80045 United States, District Of Columbia Medstar Georgetown University HospitalWashington, District Of Columbia, United States, 20007|Miami, Florida, United States, 33136 Mid-Florida Hematology OncologyOrange, Florida, United States, 32763|Atlanta, Georgia, United States, 30318-0922|Chicago, Illinois, United States, 60612|Louisville, Kentucky, United States, 40202|Ann Arbor, Michigan, United States, 48109-5000|Omaha, Nebraska, United States, 68198-0600|Bronx, New York, United States, 10461 Weill Cornell Medical CollegeNew York, New York, United States, 10029|Charlotte, North Carolina, United States, 28204 Duke UniversityDurham, North Carolina, United States, 27701 Wake Forest University - Baptist Medical CenterWinston-Salem, North Carolina, United States, 27157|Hershey, Pennsylvania, United States, 17033|Columbia, South Carolina, United States, 65212-1000|Fort Worth, Texas, United States, 76104 Md Anderson Cancer CenterHouston, Texas, United States, 77030|Seattle, Washington, United States, 98109-1023","Alaska|Arizona|California|Colorado|Florida|Georgia|Illinois|Kentucky|Michigan|Nebraska|New York|North Carolina|Pennsylvania|South Carolina|Texas|Washington","Australia|Austria|Belgium|Brazil|Canada|China|France|Germany|Greece|Hungary|India|Israel|Italy|Japan|Mexico|Netherlands|Portugal|Spain|Turkey|Ukraine|United Kingdom|United States","Chris O'Brien Lifehouse|Lkh-Univ. Klinikum Graz|Olv Ziekenhuis Aalst|Fundacao Pio Xii - Hospital De Cancer De Barretos|British Columbia Bc Cancer Agency - Southern Interior|Manitoba Cancercare Manitoba|Peking University First Hospital|Institut De CancÃ©rologie De L'Ouest (Ico)|Vivantes Klinikum Am Urban|University General Hospital Of Rio Patras|Semmelweis Egyetem|Manipal Comprehensive Cancer Centre, Manipal Hospital|Rambam Health Care Campus|Azienda Ospedaliera Nazionale Ss. Antonio E Biagio E Cesare Arrigo Alessandria|Hirosaki University School Of Medicine & Hospital|San Peregrino Cancer Center|St. Antonius Ziekenhuis Nieuwegein|Hospital LusÃ­adas|Hosp. Univ. Infanta Cristina|Adana Baskent Practice And Research Hospital|Chernivtsi Regional Clinical Hospital|University Hospitals Bristol - Bristol Haematology & Oncolog|Alaska Urological Institute Dba Alaska Clinical Research Center|University Of Ua Cancer Center(Uacc)/Dh-Sjhmc|University Of Calif Davis Medical Center|Uchealth Anschutz Cancer Pavilion|University Of Miami/Sylvester Cancer Center|Piedmont Cancer Institute|Northwestern University|Norton Cancer Institute|University Of Michigan Health System|University Of Nebraska Medical Center|Montefiore Medical Center|Levine Cancer Institute, Carolinas Healthcare System|Penn State Hershey Cancer Institute|University Of Missouri|The Center For Cancer And Blood Disorders|Seattle Cancer Care Alliance",{"$nulls":3},"Janssen Research & Development, LLC Clinical Trials","2018-05-31","2020-05-25T16:35:11.913","2020-05-26T17:10:42.972","NCT03390504"]
["5ecbf3bffeab101b155307cc","NCT03390504","2018-06-29","Johnson & Johnson","JNJ","Recruiting","A Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Participants With Advanced Urothelial Cancer and Selected Fibroblast Growth Factor Receptor (FGFR) Gene Aberrations","Erdafitinib|Fibroblast|Vinflunine|Docetaxel|Pembrolizumab","FGFR Antagonist|Tubulin Inhibitor|Mitosis Inhibitor|Tubulin Inhibitor|PD-1 Inhibitor","Yes","['Erdafitinib', 'Fibroblast', 'Vinflunine']","No",null,"Phase 3",4,631,"Anticipated","2018-03-23","2020-11-24","OS","Overall Survival",{"$nulls":3},"The purpose of this study is to evaluate efficacy of erdafitinib versus chemotherapy or pembrolizumab in participants with advanced urothelial cancer harboring selected fibroblast growth factor receptor (FGFR) aberrations who have progressed after one prior treatment.","A study of erdafitinib versus standard of care, consisting of chemotherapy (docetaxel or vinflunine) or PD1 agent pembrolizumab, in participants with advanced urothelial cancer and selected FGFR aberrations who have progressed on or after one prior line of systemic therapy. It will consist of screening, treatment phase (from randomization until disease progression, intolerable toxicity, withdrawal of consent or decision by investigator to discontinue treatment else participants will discontinue treatment after completion of 2 years pembrolizumab therapy), post-treatment follow-up (from end-of-treatment to participants death, withdraws consent, lost to follow-up, or end of study, whichever comes first). Efficacy, pharmacokinetics, biomarkers, patient reported outcomes, medical resource utilization and safety will be assessed.","A Phase 3 Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Subjects With Advanced Urothelial Cancer and Selected FGFR Gene Aberrations","CR108401","Urothelial Cancer","Transitional Cell Carcinoma","Oncology Solid Tumor","Oncology","Experimental","Cohort 1 (Arm 1A): Erdafitinib|Cohort 1 (Arm 1B): Vinflunine or Docetaxel|Cohort 2 (Arm 2A): Erdafitinib|Cohort 2 (Arm 2B): Pembrolizumab","Participants will be screened based on Fibroblast Growth Factor Receptor inhibitor Clinical Trial Assay (FGFRi CTA) to determine molecular eligibility and participants who meet molecular eligibility criteria will be enrolled. Participants (treated with prior anti-anti-programmed cell death protein [PD][L]1 agent) will swallow erdafitinib tablets orally at a starting dose of 8 milligram (mg), once daily for 21 days in a 21-day cycle until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustment are based on phosphate level and observed toxicity (adverse events [AEs]).|Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be enrolled. Participants (treated with prior anti-PD[L]1 agent) will receive vinflunine 320 milligram per meter square (mg/m^2) as a 20-minute intravenous infusion once every 3 weeks or docetaxel 75 mg/m^2 as a 1 hour intravenous infusion every 3 weeks. Treatment with either agent (choice of investigator) will be administered until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustments are based on observed toxicities.|Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be enrolled. Participants (no prior treatment with anti-PD(L)1 agent) will swallow erdafitinib tablets orally at a starting dose of 8 mg, once daily for 21 days in a 21-day cycle until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustments are based on phosphate level and observed toxicity (AEs).|Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be enrolled. Participants (no prior treatment with anti-PD(L)1 agent) will receive pembrolizumab 200 mg as a 30-minute intravenous infusion once every 3 weeks, until disease progression, intolerable toxicity, withdrawal of consent, decision by the investigator to discontinue treatment or the completion of 2 years of pembrolizumab therapy. Dose adjustments are based on observed toxicities.","Drug|Device","Erdafitinib|Fibroblast Growth Factor Receptor inhibitor Clinical Trial Assay (FGFRi CTA)|Vinflunine|Docetaxel|Pembrolizumab","Participants will swallow erdafitinib tablets orally at a starting dose of 8 mg.|FGFRi CTA will be used to determine molecular eligibility.|Participants will receive vinflunine 320 mg/m^2 as a 20-minute intravenous infusion.|Participants will receive docetaxel 75 mg/m^2 as a 1 hour intravenous infusion.|Participants will receive pembrolizumab 200 mg as a 30-minute intravenous infusion.","JNJ-42756493","Cohort 1 (Arm 1A): Erdafitinib|Cohort 1 (Arm 1B): Vinflunine or Docetaxel|Cohort 2 (Arm 2A): Erdafitinib|Cohort 2 (Arm 2B): Pembrolizumab","\n\n * Histologic demonstration of transitional cell carcinoma of the urothelium. Minor components ( less than [<] 50 percent [%] overall) of variant histology such as glandular or squamous differentiation, or evolution to more aggressive phenotypes such as sarcomatoid or micropapillary change are acceptable\n * Stage IV disease (metastatic or surgically unresectable, cT4b, N+, or M+ cancer)\n * Documented progression of disease, defined as any progression that requires a change in treatment, prior to randomization\n * Only one line of prior systemic treatment for metastatic urothelial cancer. Participants who received neoadjuvant or adjuvant chemotherapy and showed disease progression (as defined above), within 12 months of the last dose are considered to have received systemic chemotherapy in the metastatic setting Cohort 1: prior chemotherapy and anti-PD(L)1 [in combination or in maintenance setting] (anti-PD(L)1 alone is allowed only for participants with documented cisplatin ineligibility) and Cohort 2: prior chemotherapy (no prior anti-PD(L)1 treatment)\n * A woman of childbearing potential who is sexually active must have a negative pregnancy test (beta human chorionic gonadotropin [beta hCG]) at Screening (urine or serum)\n * Participants must meet appropriate molecular eligibility criteria\n * Eastern Cooperative Oncology Group (ECOG) performance status Grade 0, 1, or 2\n * Adequate bone marrow, liver, and renal function\n\n","\n\n * Treatment with any other investigational agent or participation in another clinical study with therapeutic intent within 30 days prior to randomization\n * Active malignancies (that is, requiring treatment change in the last 24 months) other than urothelial cancer (except skin cancers within the last 24 months that is considered completely cured)\n * Symptomatic central nervous system metastases\n * Received prior fibroblast growth factor receptor (FGFR) inhibitor treatment\n * Known allergies, hypersensitivity, or intolerance to erdafitinib or its excipients\n * Corneal or retinal abnormality likely to increase the risk of eye toxicity\n * History of uncontrolled cardiovascular disease including\n * Impaired wound healing capacity defined as skin/decubitus ulcers, chronic leg ulcers, known gastric ulcers, or unhealed incisions",{"$nulls":4},"Actual","2018-01-04","Actual","Anticipated","2021-05-27","Anticipated","2018-06-01","2017-12-20","2018-01-03","2018-06-28","Yes",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No",null,null,"URL: http://pam.sylogent.com/cr/CR108401 [http://pam.sylogent.com/cr/CR108401] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To learn how to participate in this trial please click here.",null,"Yes","Yes",{"$nulls":17},"2017-002932-18|42756493BLC3001","EudraCT Number|Janssen Research & Development, LLC","Overall Survival (OS)","Overall survival is measured from the date of randomization to the date of the participant's death. If the participant is alive or the vital status is unknown, the participant will be censored at the date the participant was last known to be alive.","Date of first randomization to the date of participant's death (approximately up to 3 years)","Progression-free Survival (PFS)|Overall Response Rate (ORR)|Time to Worsening in Symptom Items and Functioning Subscales in Patient-Reported Health Status of the Functional Assessment of Cancer Therapy-Bladder Cancer (FACT-Bl)|Change from Baseline in Patient-Global Impression of Severity (PGIS) Score|Change from Baseline in the Visual Analog Scale (VAS) of the EQ-5D-5L|Change from Baseline in the Utility Scale of the EQ-5D-5L|Duration of Response (DOR)|Number of Participants with Adverse Events (AEs) as a Measure of Safety|Oral Clearance (CL/F) of Erdafitinib|Area Under the Plasma Concentration-Time Curve from Time Zero to Time 't' (AUC[0-t]) of Erdafitinib","PFS is defined as duration in days from date of randomization to disease progression date (assessed per Response Evaluation Criteria in Solid Tumors Version 1.1|ORR is defined as the proportion of participants who achieve CR (CR; disappearance of all target lesions and disappearance of all non-target lesions and normalization of tumor marker level) or partial response (PR; at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters), as assessed per RECIST v1.1 by the investigator.|The FACT-Bl consists of 36 core items, with 5-point Likert response scales, covering 5 primary domains: Physical well-being, social/family well-being, emotional well-being, functional well-being and bladder symptom subscale. The answer scales range from \"Not at all (score=0)\" to \"very much (score=4)\" to assess the meaningful significant symptom deterioration.|The PGIS is a single question regarding the participant report of disease severity. Participants will be asked that ''considering all aspects of your bladder cancer symptoms right now, would you say your bladder cancer symptoms are none, mild, moderate, severe, or very severe?\" The PGIS is an anchor question that will be used to establish the magnitude of meaningful change in this study by assessing disease severity.|European Quality of Life 5 Dimensions (EQ-5D) visual analog scale (VAS) is a 20 centimeter (cm) vertical VAS with scores ranging from 0 (worst imaginable health) to 100 (perfect health). A higher score indicates an improvement in health in the Health Status Index.|The EuroQol-5 is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating \"full health\" and 0 representing dead.|DOR for responders is defined as duration in days from the date of initial documentation of a response to the date of first documented evidence of progressive disease (PD) or relapse for participants who experience CR (CR; disappearance of all target lesions and disappearance of all non-target lesions and normalization of tumor marker level) during the study or death.|An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.|CL/F is the oral clearance; that is clearance based on oral bioavailability of erdafitinib.|AUC(0-t) is the area under the plasma concentration-time curve from time zero to any time 't' of erdafitinib.","RECIST v1.1 by investigator) or relapse from CR or death, whichever is reported first. RECIST 1.1, progressive disease is defined as a 20 percent (%) increase in the sum of diameters of all target lesions and a minimum absolute increase of 5 millimeter (mm) in the sum. CR is defined as disappearance of all target lesions, non-target lesions and normalization of tumor marker level.|Approximately up to 3 years|Baseline up to end of treatment (approximately 3 years)|Baseline up to follow up phase (approximately 3 years)|From the date of initial documentation of a response to date of first documented evidence of progressive disease (or participants relapse who experience CR during the study) or death (approximately up to 3 years)|Day 14 (Cycle 1), Day 1 (Cycle 2) (each cycle is of 21 days)","JNJ.CT@sylogent.com","Study Contact","844-434-4210",{"$cut":{"chars":16428,"head":"Camperdown, Australia, 2050 Peninsula & South Eastern Haematology And Oncology GroupFrankston, Australia, 3199 Royal Hobart HospitalHobart, Australia, 7000 Peter Maccallum Cancer CentreMelbourne, Australia, 3000 Frankston HospitalMelbourne, Australia, 3199 Southside Cancer Care CentreMiranda, Australia, 2228 Sir Charles Gairdner HospitalNedlands, Australia, 6009|Graz, Austria, 8036 Krankenhaus Der Barmherzigen SchwesternLinz, Austria, 4010 Lkh - UniversitÃ¤tsklinikum Der Pmu SalzburgSalzburg, Austria, 5020 Medical University Vienna, MuvVienna, Austria, A-1090|Aalst, Belgium, 9300 Zna MiddelheimAntwerpen, Belgium, 2020 Cliniques Universitaires Saint-LucBrussel, Belgium, 1200 Clinique Notre Dame De GrÃ¢ceCharleroi, Belgium, 6000 Az Maria MiddelaresGent, Belgium, 9000 Universitair Ziekenhuis GentGent, Belgium, 9000 Chc-Cliniques Saint-JosephLiÃ¨ge, Belgium, 4000 Sint-Augustinus AzWilrijk, Belgium, 2610 Chu Dinant Godinne Ucl NamurYvoir, Belgium, 5530|Barretos, Brazil, 14784-400 AssociaÃ§Ã£o MÃ¡rio Penna\\NÃºcleo De Ensino E PesquisasBelo Horizonte, Brazil, 30380-472 Hospital Erasto GaertnerCuritiba, Brazil, 81520-060 ClÃ­nica De Neoplasias Litoral Ltda.Itajai, Brazil, 88301-220 Upco - HcpaPorto Alegre, Brazil, 90035-903 Inca - Instituto Nacional Do CancerRio De Janeiro, Brazil, 20231-050 Fundacao Antonio PrudenteSao Paulo, Brazil, 01509900 Hospital De Base De SÃ£o JosÃ© Do Rio PretoSÃ£o JosÃ© Do Rio Preto, Brazil, 15090-000 Sociedade Beneficiante De Senhoras - Hospital Sirio LibanesSÃ£o Paulo, Brazil, 01308901 Cepho - Faculdade De Medicina Do AbcSÃ£o Paulo, Brazil, 09060-650|Kelowna, British Columbia, Canada, V1Y 5L3 Vancouver Cancer CentreVancouver, British Columbia, Canada, V5Z 4E6|Winnipeg, Manitoba, Canada, R3E 0V9|Thunder Bay, Ontario, Canada, P7B 6V4 Princess Margaret Hospital- UhnToronto, Ontario, Canada, M5G 2M9|Beijing, China, 100034 Beijing Friendship HospitalBeijing, China, 100050 Peking University Third HospitalBeijing, China, 100191 Beijing HospitalBeijing, China, 100730 Peking Union Medical College HospitalBeijing, China, 100730 Sichuan Provincial People'S HospitalChengdu, China, 610000 Sun Yat-Sen Memorial Hospital, Sun Yat-Sen UniversityGuangzhou, China, 510120 Guangzhou First Municipal People'S HospitalGuangzhou, China, 510180 Zhejiang Provincial People'S HospitalHangzhou, China, 310000 Sir Run Run Shaw Hospital, Zhejiang UniversityHangzhou, China, 310016 The First Affliated Hospital Of Nanchang UniversityNanchang, China, 330006 Nanjing Drum Tower HospitalNanjing, China, 210008 Jiangsu Cancer HospitalNanjing, China, 210009 Renji Hospital, Shanghai Jiaotong University School Of MedicineShanghai, China, 200127 Huadong Hospital Affiliated To Fudan UniversityShanghai, China, 200400 First Affiliated Hospital, Xi'An Jiaotong UniversityXi'An, China, 710061|Angers, France, 49055 Hopital Jean MinjozBesancon Cedex, France, 25030 Institut BergoniÃ©Bordeaux, France, 33000 Centre Jean PerrinClermont Ferrand, France, 63011 Hopital Henri MondorCreteil, France, 94010 Centre Georges-FranÃ§ois LeclercDijon, France, 21079 Centre Oscar LambretLille, France, 59020 Centre Leon BÃ©rardLyon, France, 69008 Hopital De La TimoneMarseille, France, 13005 Institut Regional Du Cancer De Montpellier Val D'AurelleMontpellier, France, 34298 Centre Antoine LacassagneNice, France, 06189 Institut De CancÃ©rologie Du GardNÃ®mes, France, 30029 Hopital Europeen Georges-PompidouParis, France, 75015 Hospices Civils De Lyon HclPierre-BÃ©nite, France, 69495 Chu De PoitiersPoitiers Cedex, France, 86021 Centre Hopitalier Inter-Communal De CornouailleQuimper, France, 2900 Centre Eugene MarquisRennes Cedex, France, 35062 I.C.O. RenÃ© GauducheauSaint Herblain Cedex, France, 44805 Institut De CancÃ©rologie De LoireSaint-Priest-En-Jarez, France, 42271 Hopitaux Universitaires De StrasbourgStrasbourg, France, 67091 Institut Claudius RegaudToulouse, France, 31059 Institut Gustave RoussyVillejuif, France, 94805|Berlin, Germany, 10967 Universitatsklinikum Carl Gustav Carcus DresdenDresden, Germany, 01307 Universitaetsklinikum DuesseldorfDuesseldorf, Germany, 4022"}},"Alaska|Arizona|California|Colorado|Florida|Georgia|Illinois|Kentucky|Michigan|Nebraska|Nevada|New York|North Carolina|Pennsylvania|South Carolina|Texas|Washington","Australia|Austria|Belgium|Brazil|Canada|China|France|Germany|Greece|Hungary|India|Israel|Italy|Japan|Mexico|Netherlands|Portugal|Spain|Turkey|Ukraine|United Kingdom|United States","Chris O'Brien Lifehouse|Lkh-Univ. Klinikum Graz|Olv Ziekenhuis Aalst|Fundacao Pio Xii - Hospital De Cancer De Barretos|British Columbia Bc Cancer Agency - Southern Interior|Manitoba Cancercare Manitoba|Ontario Thunder Bay Regional Health Sciences Centre|Peking University First Hospital|Institut De CancÃ©rologie De L'Ouest (Ico)|Vivantes Klinikum Am Urban|University General Hospital Of Rio Patras|Semmelweis Egyetem|Manipal Comprehensive Cancer Centre, Manipal Hospital|Rambam Health Care Campus|Azienda Ospedaliera Nazionale Ss. Antonio E Biagio E Cesare Arrigo Alessandria|Hirosaki University School Of Medicine & Hospital|San Peregrino Cancer Center|St. Antonius Ziekenhuis Nieuwegein|Hospital LusÃ­adas|Hosp. Univ. Infanta Cristina|Adana Baskent Practice And Research Hospital|Chernivtsi Regional Clinical Hospital|University Hospitals Bristol - Bristol Haematology & Oncolog|Alaska Urological Institute Dba Alaska Clinical Research Center|University Of Ua Cancer Center(Uacc)/Dh-Sjhmc|University Of Calif Davis Medical Center|Uchealth Anschutz Cancer Pavilion|University Of Miami/Sylvester Cancer Center|Piedmont Cancer Institute|Northwestern University|Norton Cancer Institute|University Of Michigan Health System|University Of Nebraska Medical Center|Va Medical Center|Montefiore Medical Center|Levine Cancer Institute, Carolinas Healthcare System|Penn State Hershey Cancer Institute|University Of Missouri|The Center For Cancer And Blood Disorders|Seattle Cancer Care Alliance",{"$nulls":3},"Janssen Research & Development, LLC Clinical Trials","2018-06-28","2020-05-25T16:35:11.919","2020-05-26T17:10:42.972","NCT03390504"]
["5ecbf3bfe2561b1b11905c98","NCT03390504","2018-07-27","Johnson & Johnson","JNJ","Recruiting","A Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Participants With Advanced Urothelial Cancer and Selected Fibroblast Growth Factor Receptor (FGFR) Gene Aberrations","Erdafitinib|Fibroblast|Vinflunine|Docetaxel|Pembrolizumab","FGFR Antagonist|Tubulin Inhibitor|Mitosis Inhibitor|Tubulin Inhibitor|PD-1 Inhibitor","Yes","['Erdafitinib', 'Fibroblast', 'Vinflunine']","No",null,"Phase 3",4,631,"Anticipated","2018-03-23","2020-11-24","OS","Overall Survival",{"$nulls":3},"The purpose of this study is to evaluate efficacy of erdafitinib versus chemotherapy or pembrolizumab in participants with advanced urothelial cancer harboring selected fibroblast growth factor receptor (FGFR) aberrations who have progressed after one prior treatment.","A study of erdafitinib versus standard of care, consisting of chemotherapy (docetaxel or vinflunine) or PD1 agent pembrolizumab, in participants with advanced urothelial cancer and selected FGFR aberrations who have progressed on or after one prior line of systemic therapy. It will consist of screening, treatment phase (from randomization until disease progression, intolerable toxicity, withdrawal of consent or decision by investigator to discontinue treatment else participants will discontinue treatment after completion of 2 years pembrolizumab therapy), post-treatment follow-up (from end-of-treatment to participants death, withdraws consent, lost to follow-up, or end of study, whichever comes first). Efficacy, pharmacokinetics, biomarkers, patient reported outcomes, medical resource utilization and safety will be assessed.","A Phase 3 Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Subjects With Advanced Urothelial Cancer and Selected FGFR Gene Aberrations","CR108401","Urothelial Cancer","Transitional Cell Carcinoma","Oncology Solid Tumor","Oncology","Experimental","Cohort 1 (Arm 1A): Erdafitinib|Cohort 1 (Arm 1B): Vinflunine or Docetaxel|Cohort 2 (Arm 2A): Erdafitinib|Cohort 2 (Arm 2B): Pembrolizumab","Participants will be screened based on Fibroblast Growth Factor Receptor inhibitor Clinical Trial Assay (FGFRi CTA) to determine molecular eligibility and participants who meet molecular eligibility criteria will be enrolled. Participants (treated with prior anti-anti-programmed cell death protein [PD][L]1 agent) will swallow erdafitinib tablets orally at a starting dose of 8 milligram (mg), once daily for 21 days in a 21-day cycle until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustment are based on phosphate level and observed toxicity (adverse events [AEs]).|Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be enrolled. Participants (treated with prior anti-PD[L]1 agent) will receive vinflunine 320 milligram per meter square (mg/m^2) as a 20-minute intravenous infusion once every 3 weeks or docetaxel 75 mg/m^2 as a 1 hour intravenous infusion every 3 weeks. Treatment with either agent (choice of investigator) will be administered until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustments are based on observed toxicities.|Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be enrolled. Participants (no prior treatment with anti-PD(L)1 agent) will swallow erdafitinib tablets orally at a starting dose of 8 mg, once daily for 21 days in a 21-day cycle until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustments are based on phosphate level and observed toxicity (AEs).|Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be enrolled. Participants (no prior treatment with anti-PD(L)1 agent) will receive pembrolizumab 200 mg as a 30-minute intravenous infusion once every 3 weeks, until disease progression, intolerable toxicity, withdrawal of consent, decision by the investigator to discontinue treatment or the completion of 2 years of pembrolizumab therapy. Dose adjustments are based on observed toxicities.","Drug|Device","Erdafitinib|Fibroblast Growth Factor Receptor inhibitor Clinical Trial Assay (FGFRi CTA)|Vinflunine|Docetaxel|Pembrolizumab","Participants will swallow erdafitinib tablets orally at a starting dose of 8 mg.|FGFRi CTA will be used to determine molecular eligibility.|Participants will receive vinflunine 320 mg/m^2 as a 20-minute intravenous infusion.|Participants will receive docetaxel 75 mg/m^2 as a 1 hour intravenous infusion.|Participants will receive pembrolizumab 200 mg as a 30-minute intravenous infusion.","JNJ-42756493","Cohort 1 (Arm 1A): Erdafitinib|Cohort 1 (Arm 1B): Vinflunine or Docetaxel|Cohort 2 (Arm 2A): Erdafitinib|Cohort 2 (Arm 2B): Pembrolizumab","\n\n * Histologic demonstration of transitional cell carcinoma of the urothelium. Minor components ( less than [<] 50 percent [%] overall) of variant histology such as glandular or squamous differentiation, or evolution to more aggressive phenotypes such as sarcomatoid or micropapillary change are acceptable\n * Stage IV disease (metastatic or surgically unresectable, cT4b, N+, or M+ cancer)\n * Documented progression of disease, defined as any progression that requires a change in treatment, prior to randomization\n * Only one line of prior systemic treatment for metastatic urothelial cancer. Participants who received neoadjuvant or adjuvant chemotherapy and showed disease progression (as defined above), within 12 months of the last dose are considered to have received systemic chemotherapy in the metastatic setting Cohort 1: prior chemotherapy and anti-PD(L)1 [in combination or in maintenance setting] (anti-PD(L)1 alone is allowed only for participants with documented cisplatin ineligibility) and Cohort 2: prior chemotherapy (no prior anti-PD(L)1 treatment)\n * A woman of childbearing potential who is sexually active must have a negative pregnancy test (beta human chorionic gonadotropin [beta hCG]) at Screening (urine or serum)\n * Participants must meet appropriate molecular eligibility criteria\n * Eastern Cooperative Oncology Group (ECOG) performance status Grade 0, 1, or 2\n * Adequate bone marrow, liver, and renal function\n\n","\n\n * Treatment with any other investigational agent or participation in another clinical study with therapeutic intent within 30 days prior to randomization\n * Active malignancies (that is, requiring treatment change in the last 24 months) other than urothelial cancer (except skin cancers within the last 24 months that is considered completely cured)\n * Symptomatic central nervous system metastases\n * Received prior fibroblast growth factor receptor (FGFR) inhibitor treatment\n * Known allergies, hypersensitivity, or intolerance to erdafitinib or its excipients\n * Corneal or retinal abnormality likely to increase the risk of eye toxicity\n * History of uncontrolled cardiovascular disease including\n * Impaired wound healing capacity defined as skin/decubitus ulcers, chronic leg ulcers, known gastric ulcers, or unhealed incisions",{"$nulls":4},"Actual","2018-01-04","Actual","Anticipated","2021-05-27","Anticipated","2018-07-01","2017-12-20","2018-01-03","2018-07-26","Yes",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No",null,null,"URL: http://pam.sylogent.com/cr/CR108401 [http://pam.sylogent.com/cr/CR108401] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To learn how to participate in this trial please click here.",null,"Yes","Yes",{"$nulls":17},"2017-002932-18|42756493BLC3001","EudraCT Number|Janssen Research & Development, LLC","Overall Survival (OS)","Overall survival is measured from the date of randomization to the date of the participant's death. If the participant is alive or the vital status is unknown, the participant will be censored at the date the participant was last known to be alive.","Date of first randomization to the date of participant's death (approximately up to 3 years)","Progression-free Survival (PFS)|Overall Response Rate (ORR)|Time to Worsening in Symptom Items and Functioning Subscales in Patient-Reported Health Status of the Functional Assessment of Cancer Therapy-Bladder Cancer (FACT-Bl)|Change from Baseline in Patient-Global Impression of Severity (PGIS) Score|Change from Baseline in the Visual Analog Scale (VAS) of the EQ-5D-5L|Change from Baseline in the Utility Scale of the EQ-5D-5L|Duration of Response (DOR)|Number of Participants with Adverse Events (AEs) as a Measure of Safety|Oral Clearance (CL/F) of Erdafitinib|Area Under the Plasma Concentration-Time Curve from Time Zero to Time 't' (AUC[0-t]) of Erdafitinib","PFS is defined as duration in days from date of randomization to disease progression date (assessed per Response Evaluation Criteria in Solid Tumors Version 1.1|ORR is defined as the proportion of participants who achieve CR (CR; disappearance of all target lesions and disappearance of all non-target lesions and normalization of tumor marker level) or partial response (PR; at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters), as assessed per RECIST v1.1 by the investigator.|The FACT-Bl consists of 36 core items, with 5-point Likert response scales, covering 5 primary domains: Physical well-being, social/family well-being, emotional well-being, functional well-being and bladder symptom subscale. The answer scales range from \"Not at all (score=0)\" to \"very much (score=4)\" to assess the meaningful significant symptom deterioration.|The PGIS is a single question regarding the participant report of disease severity. Participants will be asked that ''considering all aspects of your bladder cancer symptoms right now, would you say your bladder cancer symptoms are none, mild, moderate, severe, or very severe?\" The PGIS is an anchor question that will be used to establish the magnitude of meaningful change in this study by assessing disease severity.|European Quality of Life 5 Dimensions (EQ-5D) visual analog scale (VAS) is a 20 centimeter (cm) vertical VAS with scores ranging from 0 (worst imaginable health) to 100 (perfect health). A higher score indicates an improvement in health in the Health Status Index.|The EuroQol-5 is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating \"full health\" and 0 representing dead.|DOR for responders is defined as duration in days from the date of initial documentation of a response to the date of first documented evidence of progressive disease (PD) or relapse for participants who experience CR (CR; disappearance of all target lesions and disappearance of all non-target lesions and normalization of tumor marker level) during the study or death.|An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.|CL/F is the oral clearance; that is clearance based on oral bioavailability of erdafitinib.|AUC(0-t) is the area under the plasma concentration-time curve from time zero to any time 't' of erdafitinib.","RECIST v1.1 by investigator) or relapse from CR or death, whichever is reported first. RECIST 1.1, progressive disease is defined as a 20 percent (%) increase in the sum of diameters of all target lesions and a minimum absolute increase of 5 millimeter (mm) in the sum. CR is defined as disappearance of all target lesions, non-target lesions and normalization of tumor marker level.|Approximately up to 3 years|Baseline up to end of treatment (approximately 3 years)|Baseline up to follow up phase (approximately 3 years)|From the date of initial documentation of a response to date of first documented evidence of progressive disease (or participants relapse who experience CR during the study) or death (approximately up to 3 years)|Day 14 (Cycle 1), Day 1 (Cycle 2) (each cycle is of 21 days)","JNJ.CT@sylogent.com","Study Contact","844-434-4210",{"$cut":{"chars":16464,"head":"Camperdown, Australia, 2050 Peninsula & South Eastern Haematology And Oncology GroupFrankston, Australia, 3199 Royal Hobart HospitalHobart, Australia, 7000 Peter Maccallum Cancer CentreMelbourne, Australia, 3000 Frankston HospitalMelbourne, Australia, 3199 Southside Cancer Care CentreMiranda, Australia, 2228 Sir Charles Gairdner HospitalNedlands, Australia, 6009|Graz, Austria, 8036 Krankenhaus Der Barmherzigen SchwesternLinz, Austria, 4010 Lkh - UniversitÃ¤tsklinikum Der Pmu SalzburgSalzburg, Austria, 5020 Medical University Vienna, MuvVienna, Austria, A-1090|Aalst, Belgium, 9300 Zna MiddelheimAntwerpen, Belgium, 2020 Cliniques Universitaires Saint-LucBrussel, Belgium, 1200 Clinique Notre Dame De GrÃ¢ceCharleroi, Belgium, 6000 Az Maria MiddelaresGent, Belgium, 9000 Universitair Ziekenhuis GentGent, Belgium, 9000 Chc-Cliniques Saint-JosephLiÃ¨ge, Belgium, 4000 Sint-Augustinus AzWilrijk, Belgium, 2610 Chu Dinant Godinne Ucl NamurYvoir, Belgium, 5530|Barretos, Brazil, 14784-400 AssociaÃ§Ã£o MÃ¡rio Penna\\NÃºcleo De Ensino E PesquisasBelo Horizonte, Brazil, 30380-472 Hospital Erasto GaertnerCuritiba, Brazil, 81520-060 ClÃ­nica De Neoplasias Litoral Ltda.Itajai, Brazil, 88301-220 Upco - HcpaPorto Alegre, Brazil, 90035-903 Inca - Instituto Nacional Do CancerRio De Janeiro, Brazil, 20231-050 Fundacao Antonio PrudenteSao Paulo, Brazil, 01509900 Hospital De Base De SÃ£o JosÃ© Do Rio PretoSÃ£o JosÃ© Do Rio Preto, Brazil, 15090-000 Sociedade Beneficiante De Senhoras - Hospital Sirio LibanesSÃ£o Paulo, Brazil, 01308901 Cepho - Faculdade De Medicina Do AbcSÃ£o Paulo, Brazil, 09060-650|Kelowna, British Columbia, Canada, V1Y 5L3 Vancouver Cancer CentreVancouver, British Columbia, Canada, V5Z 4E6|Winnipeg, Manitoba, Canada, R3E 0V9|Thunder Bay, Ontario, Canada, P7B 6V4 Princess Margaret Hospital- UhnToronto, Ontario, Canada, M5G 2M9|Beijing, China, 100034 Beijing Friendship HospitalBeijing, China, 100050 Peking University Third HospitalBeijing, China, 100191 Beijing HospitalBeijing, China, 100730 Peking Union Medical College HospitalBeijing, China, 100730 Sichuan Provincial People'S HospitalChengdu, China, 610000 Sun Yat-Sen Memorial Hospital, Sun Yat-Sen UniversityGuangzhou, China, 510120 Guangzhou First Municipal People'S HospitalGuangzhou, China, 510180 Zhejiang Provincial People'S HospitalHangzhou, China, 310000 Sir Run Run Shaw Hospital, Zhejiang UniversityHangzhou, China, 310016 The First Affliated Hospital Of Nanchang UniversityNanchang, China, 330006 Nanjing Drum Tower HospitalNanjing, China, 210008 Jiangsu Cancer HospitalNanjing, China, 210009 Renji Hospital, Shanghai Jiaotong University School Of MedicineShanghai, China, 200127 Huadong Hospital Affiliated To Fudan UniversityShanghai, China, 200400 First Affiliated Hospital, Xi'An Jiaotong UniversityXi'An, China, 710061|Angers, France, 49055 Hopital Jean MinjozBesancon Cedex, France, 25030 Institut BergoniÃ©Bordeaux, France, 33000 Centre Jean PerrinClermont Ferrand, France, 63011 Hopital Henri MondorCreteil, France, 94010 Centre Georges-FranÃ§ois LeclercDijon, France, 21079 Centre Oscar LambretLille, France, 59020 Centre Leon BÃ©rardLyon, France, 69008 Hopital De La TimoneMarseille, France, 13005 Institut Regional Du Cancer De Montpellier Val D'AurelleMontpellier, France, 34298 Centre Antoine LacassagneNice, France, 06189 Institut De CancÃ©rologie Du GardNÃ®mes, France, 30029 Hopital Europeen Georges-PompidouParis, France, 75015 Hospices Civils De Lyon HclPierre-BÃ©nite, France, 69495 Chu De PoitiersPoitiers Cedex, France, 86021 Centre Hopitalier Inter-Communal De CornouailleQuimper, France, 2900 Centre Eugene MarquisRennes Cedex, France, 35062 I.C.O. RenÃ© GauducheauSaint Herblain Cedex, France, 44805 Institut De CancÃ©rologie De LoireSaint-Priest-En-Jarez, France, 42271 Hopitaux Universitaires De StrasbourgStrasbourg, France, 67091 Institut Claudius RegaudToulouse, France, 31059 Institut Gustave RoussyVillejuif, France, 94805|Berlin, Germany, 10967 Universitatsklinikum Carl Gustav Carcus DresdenDresden, Germany, 01307 Universitaetsklinikum DuesseldorfDuesseldorf, Germany, 4022"}},"Alaska|Arizona|California|Colorado|Florida|Georgia|Illinois|Kentucky|Michigan|Nebraska|Nevada|New York|North Carolina|Pennsylvania|South Carolina|Texas|Washington","Australia|Austria|Belgium|Brazil|Canada|China|France|Germany|Greece|Hungary|India|Israel|Italy|Japan|Mexico|Netherlands|Portugal|Spain|Turkey|Ukraine|United Kingdom|United States","Chris O'Brien Lifehouse|Lkh-Univ. Klinikum Graz|Olv Ziekenhuis Aalst|Fundacao Pio Xii - Hospital De Cancer De Barretos|British Columbia Bc Cancer Agency - Southern Interior|Manitoba Cancercare Manitoba|Ontario Thunder Bay Regional Health Sciences Centre|Peking University First Hospital|Institut De CancÃ©rologie De L'Ouest (Ico)|Vivantes Klinikum Am Urban|University General Hospital Of Rio Patras|Semmelweis Egyetem|Manipal Comprehensive Cancer Centre, Manipal Hospital|Rambam Health Care Campus|Azienda Ospedaliera Nazionale Ss. Antonio E Biagio E Cesare Arrigo Alessandria|Hirosaki University School Of Medicine & Hospital|San Peregrino Cancer Center|St. Antonius Ziekenhuis Nieuwegein|Hospital LusÃ­adas|Hosp. Univ. Infanta Cristina|Adana Baskent Practice And Research Hospital|Chernivtsi Regional Clinical Hospital|University Hospitals Bristol - Bristol Haematology & Oncolog|Alaska Urological Institute Dba Alaska Clinical Research Center|University Of Ua Cancer Center(Uacc)/Dh-Sjhmc|University Of California Irvine Medical Center - Chao Family Comprehensive Cancer Center|Uchealth Anschutz Cancer Pavilion|University Of Miami/Sylvester Cancer Center|Piedmont Cancer Institute|Northwestern University|Norton Cancer Institute|University Of Michigan Health System|University Of Nebraska Medical Center|Va Medical Center|Montefiore Medical Center|Levine Cancer Institute, Carolinas Healthcare System|Penn State Hershey Cancer Institute|University Of Missouri|The Center For Cancer And Blood Disorders|Seattle Cancer Care Alliance",{"$nulls":3},"Janssen Research & Development, LLC Clinical Trials","2018-07-26","2020-05-25T16:35:11.967","2020-05-26T17:10:42.972","NCT03390504"]
["5ecbf3c0307e3d1b1f8d9c2d","NCT03390504","2018-09-13","Johnson & Johnson","JNJ","Recruiting","A Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Participants With Advanced Urothelial Cancer and Selected Fibroblast Growth Factor Receptor (FGFR) Gene Aberrations","Erdafitinib|Fibroblast|Vinflunine|Docetaxel|Pembrolizumab","FGFR Antagonist|Tubulin Inhibitor|Mitosis Inhibitor|Tubulin Inhibitor|PD-1 Inhibitor","Yes","['Erdafitinib', 'Fibroblast', 'Vinflunine']","No",null,"Phase 3",4,631,"Anticipated","2018-03-23","2020-11-24","OS","Overall Survival",{"$nulls":3},"The purpose of this study is to evaluate efficacy of erdafitinib versus chemotherapy or pembrolizumab in participants with advanced urothelial cancer harboring selected fibroblast growth factor receptor (FGFR) aberrations who have progressed after one prior treatment.","A study of erdafitinib versus standard of care, consisting of chemotherapy (docetaxel or vinflunine) or PD1 agent pembrolizumab, in participants with advanced urothelial cancer and selected FGFR aberrations who have progressed on or after one prior line of systemic therapy. It will consist of screening, treatment phase (from randomization until disease progression, intolerable toxicity, withdrawal of consent or decision by investigator to discontinue treatment, post-treatment follow-up (from end-of-treatment to participants death, withdraws consent, lost to follow-up, or end of study, whichever comes first). Efficacy, pharmacokinetics, biomarkers, patient reported outcomes, medical resource utilization and safety will be assessed.","A Phase 3 Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Subjects With Advanced Urothelial Cancer and Selected FGFR Gene Aberrations","CR108401","Urothelial Cancer","Transitional Cell Carcinoma","Oncology Solid Tumor","Oncology","Experimental","Cohort 1 (Arm 1A): Erdafitinib|Cohort 1 (Arm 1B): Vinflunine or Docetaxel|Cohort 2 (Arm 2A): Erdafitinib|Cohort 2 (Arm 2B): Pembrolizumab","Participants will be screened based on Fibroblast Growth Factor Receptor inhibitor Clinical Trial Assay (FGFRi CTA) to determine molecular eligibility and participants who meet molecular eligibility criteria will be enrolled. Participants (treated with prior anti-anti-programmed cell death protein [PD][L]1 agent) will swallow erdafitinib tablets orally at a starting dose of 8 milligram (mg), once daily for 21 days in a 21-day cycle until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustment are based on phosphate level and observed toxicity (adverse events [AEs]).|Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be enrolled. Participants (treated with prior anti-PD[L]1 agent) will receive vinflunine 320 milligram per meter square (mg/m^2) as a 20-minute intravenous infusion once every 3 weeks or docetaxel 75 mg/m^2 as a 1 hour intravenous infusion every 3 weeks. Treatment with either agent (choice of investigator) will be administered until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustments are based on observed toxicities.|Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be enrolled. Participants (no prior treatment with anti-PD(L)1 agent) will swallow erdafitinib tablets orally at a starting dose of 8 mg, once daily for 21 days in a 21-day cycle until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustments are based on phosphate level and observed toxicity (AEs).|Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be enrolled. Participants (no prior treatment with anti-PD(L)1 agent) will receive pembrolizumab 200 mg as a 30-minute intravenous infusion once every 3 weeks, until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustments are based on observed toxicities.","Drug|Device","Erdafitinib|Fibroblast Growth Factor Receptor inhibitor Clinical Trial Assay (FGFRi CTA)|Vinflunine|Docetaxel|Pembrolizumab","Participants will swallow erdafitinib tablets orally at a starting dose of 8 mg.|FGFRi CTA will be used to determine molecular eligibility.|Participants will receive vinflunine 320 mg/m^2 as a 20-minute intravenous infusion.|Participants will receive docetaxel 75 mg/m^2 as a 1 hour intravenous infusion.|Participants will receive pembrolizumab 200 mg as a 30-minute intravenous infusion.","JNJ-42756493","Cohort 1 (Arm 1A): Erdafitinib|Cohort 1 (Arm 1B): Vinflunine or Docetaxel|Cohort 2 (Arm 2A): Erdafitinib|Cohort 2 (Arm 2B): Pembrolizumab","\n\n * Histologic demonstration of transitional cell carcinoma of the urothelium. Minor components ( less than [<] 50 percent [%] overall) of variant histology such as glandular or squamous differentiation, or evolution to more aggressive phenotypes such as sarcomatoid or micropapillary change are acceptable\n * Metastatic or surgically unresectable urothelial cancer\n * Documented progression of disease, defined as any progression that requires a change in treatment, prior to randomization\n * Only one line of prior systemic treatment for metastatic urothelial cancer. Participants who received neoadjuvant or adjuvant chemotherapy and showed disease progression (as defined above), within 12 months of the last dose are considered to have received systemic chemotherapy in the metastatic setting Cohort 1: prior chemotherapy and anti-PD(L)1 [in combination or in maintenance setting] (anti-PD(L)1 alone is allowed only for participants with documented cisplatin ineligibility) and Cohort 2: prior chemotherapy (no prior anti-PD(L)1 treatment)\n * A woman of childbearing potential who is sexually active must have a negative pregnancy test (beta human chorionic gonadotropin [beta hCG]) at Screening (urine or serum)\n * Participants must meet appropriate molecular eligibility criteria\n * Eastern Cooperative Oncology Group (ECOG) performance status Grade 0, 1, or 2\n * Adequate bone marrow, liver, and renal function\n\n","\n\n * Treatment with any other investigational agent or participation in another clinical study with therapeutic intent within 30 days prior to randomization\n * Active malignancies (that is, requiring treatment change in the last 24 months). The only allowed exceptions are: urothelial cancer, skin cancer treated within the last 24 months that is considered completely cured, localized prostate cancer with a gleason score of 6 (treated within the last 24 months or untreated and under surveillance) and localized prostate cancer with a gleason score of 3+4 that has been treated more than 12 months prior to full study screening and considered completely cured\n * Symptomatic central nervous system metastases\n * Received prior fibroblast growth factor receptor (FGFR) inhibitor treatment\n * Known allergies, hypersensitivity, or intolerance to erdafitinib or its excipients\n * Corneal or retinal abnormality likely to increase the risk of eye toxicity or lens conditions, such as untreated mature or hypermature senile cataract, affecting visual acuity that impair the ability to interpret the Amsler grid test\n * History of uncontrolled cardiovascular disease\n * Impaired wound healing capacity defined as skin/decubitus ulcers, chronic leg ulcers, known gastric ulcers, or unhealed incisions",{"$nulls":4},"Actual","2018-01-04","Actual","Anticipated","2021-05-27","Anticipated","2018-09-01","2017-12-20","2018-01-03","2018-09-12","Yes",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No",null,null,"URL: http://pam.sylogent.com/cr/CR108401 [http://pam.sylogent.com/cr/CR108401] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To learn how to participate in this trial please click here.",null,"Yes","Yes",{"$nulls":17},"2017-002932-18|42756493BLC3001","EudraCT Number|Janssen Research & Development, LLC","Overall Survival (OS)","Overall survival is measured from the date of randomization to the date of the participant's death. If the participant is alive or the vital status is unknown, the participant will be censored at the date the participant was last known to be alive.","Date of first randomization to the date of participant's death (approximately up to 3 years)","Progression-free Survival (PFS)|Overall Response Rate (ORR)|Time to Worsening in Symptom Items and Functioning Subscales in Patient-Reported Health Status of the Functional Assessment of Cancer Therapy-Bladder Cancer (FACT-Bl)|Change from Baseline in Patient-Global Impression of Severity (PGIS) Score|Change from Baseline in the Visual Analog Scale (VAS) of the EQ-5D-5L|Change from Baseline in the Utility Scale of the EQ-5D-5L|Duration of Response (DOR)|Number of Participants with Adverse Events (AEs) as a Measure of Safety|Oral Clearance (CL/F) of Erdafitinib|Area Under the Plasma Concentration-Time Curve from Time Zero to Time 't' (AUC[0-t]) of Erdafitinib","PFS is defined as duration in days from date of randomization to disease progression date (assessed per Response Evaluation Criteria in Solid Tumors Version 1.1|ORR is defined as the proportion of participants who achieve CR (CR; disappearance of all target lesions and disappearance of all non-target lesions and normalization of tumor marker level) or partial response (PR; at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters), as assessed per RECIST v1.1 by the investigator.|The FACT-Bl consists of 36 core items, with 5-point Likert response scales, covering 5 primary domains: Physical well-being, social/family well-being, emotional well-being, functional well-being and bladder symptom subscale. The answer scales range from \"Not at all (score=0)\" to \"very much (score=4)\" to assess the meaningful significant symptom deterioration.|The PGIS is a single question regarding the participant report of disease severity. Participants will be asked that ''considering all aspects of your bladder cancer symptoms right now, would you say your bladder cancer symptoms are none, mild, moderate, severe, or very severe?\" The PGIS is an anchor question that will be used to establish the magnitude of meaningful change in this study by assessing disease severity.|European Quality of Life 5 Dimensions (EQ-5D) visual analog scale (VAS) is a 20 centimeter (cm) vertical VAS with scores ranging from 0 (worst imaginable health) to 100 (perfect health). A higher score indicates an improvement in health in the Health Status Index.|The EuroQol-5 is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating \"full health\" and 0 representing dead.|DOR for responders is defined as duration in days from the date of initial documentation of a response to the date of first documented evidence of progressive disease (PD) or relapse for participants who experience CR (CR; disappearance of all target lesions and disappearance of all non-target lesions and normalization of tumor marker level) during the study or death.|An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.|CL/F is the oral clearance; that is clearance based on oral bioavailability of erdafitinib.|AUC(0-t) is the area under the plasma concentration-time curve from time zero to any time 't' of erdafitinib.","RECIST v1.1 by investigator) or relapse from CR or death, whichever is reported first. RECIST 1.1, progressive disease is defined as a 20 percent (%) increase in the sum of diameters of all target lesions and a minimum absolute increase of 5 millimeter (mm) in the sum. CR is defined as disappearance of all target lesions, non-target lesions and normalization of tumor marker level.|Approximately up to 3 years|Baseline up to end of treatment (approximately 3 years)|Baseline up to follow up phase (approximately 3 years)|From the date of initial documentation of a response to date of first documented evidence of progressive disease (or participants relapse who experience CR during the study) or death (approximately up to 3 years)|Day 14 (Cycle 1), Day 1 (Cycle 2) (each cycle is of 21 days)","JNJ.CT@sylogent.com","Study Contact","844-434-4210",{"$cut":{"chars":16659,"head":"Camperdown, Australia, 2050 Peninsula & South Eastern Haematology And Oncology GroupFrankston, Australia, 3199 Royal Hobart HospitalHobart, Australia, 7000 Peter Maccallum Cancer CentreMelbourne, Australia, 3000 Frankston HospitalMelbourne, Australia, 3199 Southside Cancer Care CentreMiranda, Australia, 2228 Sir Charles Gairdner HospitalNedlands, Australia, 6009|Graz, Austria, 8036 Krankenhaus Der Barmherzigen SchwesternLinz, Austria, 4010 Lkh - UniversitÃ¤tsklinikum Der Pmu SalzburgSalzburg, Austria, 5020 Medical University Vienna, MuvVienna, Austria, A-1090|Aalst, Belgium, 9300 Zna MiddelheimAntwerpen, Belgium, 2020 Cliniques Universitaires Saint-LucBrussel, Belgium, 1200 Clinique Notre Dame De GrÃ¢ceCharleroi, Belgium, 6000 Az Maria MiddelaresGent, Belgium, 9000 Universitair Ziekenhuis GentGent, Belgium, 9000 Chc-Cliniques Saint-JosephLiÃ¨ge, Belgium, 4000 Sint-Augustinus AzWilrijk, Belgium, 2610 Chu Dinant Godinne Ucl NamurYvoir, Belgium, 5530|Barretos, Brazil, 14784-400 AssociaÃ§Ã£o MÃ¡rio Penna\\NÃºcleo De Ensino E PesquisasBelo Horizonte, Brazil, 30380-472 Hospital Erasto GaertnerCuritiba, Brazil, 81520-060 ClÃ­nica De Neoplasias Litoral Ltda.Itajai, Brazil, 88301-220 Upco - HcpaPorto Alegre, Brazil, 90035-903 Inca - Instituto Nacional Do CancerRio De Janeiro, Brazil, 20231-050 Fundacao Antonio PrudenteSao Paulo, Brazil, 01509900 Hospital De Base De SÃ£o JosÃ© Do Rio PretoSÃ£o JosÃ© Do Rio Preto, Brazil, 15090-000 Sociedade Beneficiante De Senhoras - Hospital Sirio LibanesSÃ£o Paulo, Brazil, 01308901 Cepho - Faculdade De Medicina Do AbcSÃ£o Paulo, Brazil, 09060-650|Kelowna, British Columbia, Canada, V1Y 5L3 Vancouver Cancer CentreVancouver, British Columbia, Canada, V5Z 4E6|Winnipeg, Manitoba, Canada, R3E 0V9|Thunder Bay, Ontario, Canada, P7B 6V4 Princess Margaret Hospital- UhnToronto, Ontario, Canada, M5G 2M9|Regina, Saskatchewan, Canada, S4T 7T1|Beijing, China, 100034 Beijing Friendship HospitalBeijing, China, 100050 Peking University Third HospitalBeijing, China, 100191 Beijing HospitalBeijing, China, 100730 Peking Union Medical College HospitalBeijing, China, 100730 Sichuan Provincial People'S HospitalChengdu, China, 610000 Sun Yat-Sen Memorial Hospital, Sun Yat-Sen UniversityGuangzhou, China, 510120 Guangzhou First Municipal People'S HospitalGuangzhou, China, 510180 Zhejiang Provincial People'S HospitalHangzhou, China, 310000 Sir Run Run Shaw Hospital, Zhejiang UniversityHangzhou, China, 310016 The First Affliated Hospital Of Nanchang UniversityNanchang, China, 330006 Nanjing Drum Tower HospitalNanjing, China, 210008 Jiangsu Cancer HospitalNanjing, China, 210009 Renji Hospital, Shanghai Jiaotong University School Of MedicineShanghai, China, 200127 Huadong Hospital Affiliated To Fudan UniversityShanghai, China, 200400 First Affiliated Hospital, Xi'An Jiaotong UniversityXi'An, China, 710061|Angers, France, 49055 Hopital Jean MinjozBesancon Cedex, France, 25030 Institut BergoniÃ©Bordeaux, France, 33000 Centre Jean PerrinClermont Ferrand, France, 63011 Centre Georges-FranÃ§ois LeclercDijon, France, 21079 Centre Oscar LambretLille, France, 59020 Centre Leon BÃ©rardLyon, France, 69008 Hopital De La TimoneMarseille, France, 13005 Institut Regional Du Cancer De Montpellier Val D'AurelleMontpellier, France, 34298 Centre Antoine LacassagneNice, France, 06189 Institut De CancÃ©rologie Du GardNÃ®mes, France, 30029 Hospital Saint-LouisParis Cedex 10, France, 75475 Hopital Europeen Georges-PompidouParis, France, 75015 Hospices Civils De Lyon HclPierre-BÃ©nite, France, 69495 Chu De PoitiersPoitiers Cedex, France, 86021 Centre Hopitalier Inter-Communal De CornouailleQuimper, France, 2900 Centre Eugene MarquisRennes Cedex, France, 35062 I.C.O. RenÃ© GauducheauSaint Herblain Cedex, France, 44805 Institut De CancÃ©rologie De LoireSaint-Priest-En-Jarez, France, 42271 Hopitaux Universitaires De StrasbourgStrasbourg, France, 67091 Institut Claudius RegaudToulouse, France, 31059 Institut Gustave RoussyVillejuif, France, 94805|Berlin, Germany, 10967 Universitatsklinikum Carl Gustav Carcus DresdenDresden, Germany, 01307 Universitaetsk"}},"Alaska|Arizona|California|Colorado|Florida|Georgia|Idaho|Illinois|Kentucky|Michigan|Nebraska|Nevada|New York|North Carolina|Pennsylvania|South Carolina|Texas|Virginia|Washington","Australia|Austria|Belgium|Brazil|Canada|China|France|Germany|Greece|Hungary|India|Israel|Italy|Japan|Mexico|Netherlands|Portugal|Spain|Turkey|Ukraine|United Kingdom|United States","Chris O'Brien Lifehouse|Lkh-Univ. Klinikum Graz|Olv Ziekenhuis Aalst|Fundacao Pio Xii - Hospital De Cancer De Barretos|British Columbia Bc Cancer Agency - Southern Interior|Manitoba Cancercare Manitoba|Ontario Thunder Bay Regional Health Sciences Centre|Saskatchewan Saskatchewan Cancer Agency (Sca) - Allan Blair Cancer Centre|Peking University First Hospital|Institut De CancÃ©rologie De L'Ouest (Ico)|Vivantes Klinikum Am Urban|University General Hospital Of Rio Patras|Semmelweis Egyetem|Manipal Comprehensive Cancer Centre, Manipal Hospital|Rambam Health Care Campus|Azienda Ospedaliera Nazionale Ss. Antonio E Biagio E Cesare Arrigo Alessandria|Hirosaki University School Of Medicine & Hospital|San Peregrino Cancer Center|St. Antonius Ziekenhuis Nieuwegein|Hospital LusÃ­adas|Hosp. Univ. Infanta Cristina|Adana Baskent Practice And Research Hospital|Chernivtsi Regional Clinical Hospital|University Hospitals Bristol - Bristol Haematology & Oncolog|Alaska Urological Institute Dba Alaska Clinical Research Center|University Of Ua Cancer Center(Uacc)/Dh-Sjhmc|University Of California Irvine Medical Center - Chao Family Comprehensive Cancer Center|Uchealth Anschutz Cancer Pavilion|University Of Miami/Sylvester Cancer Center|Piedmont Cancer Institute|St. Luke's Meridian Medical Center|Northwestern University|Norton Cancer Institute|University Of Michigan Health System|University Of Nebraska Medical Center|Va Medical Center|Montefiore Medical Center|Levine Cancer Institute, Carolinas Healthcare System|Penn State Hershey Cancer Institute|University Of Missouri|The Center For Cancer And Blood Disorders|Inova Dwiight &Martha Schar Cancer Institute|Seattle Cancer Care Alliance",{"$nulls":3},"Janssen Research & Development, LLC Clinical Trials","2018-09-12","2020-05-25T16:35:12.344","2020-05-26T17:10:42.972","NCT03390504"]
["5ecbf3c0e2561b1b11905c99","NCT03390504","2018-09-24","Johnson & Johnson","JNJ","Recruiting","A Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Participants With Advanced Urothelial Cancer and Selected Fibroblast Growth Factor Receptor (FGFR) Gene Aberrations","Erdafitinib|Fibroblast|Vinflunine|Docetaxel|Pembrolizumab","FGFR Antagonist|Tubulin Inhibitor|Mitosis Inhibitor|Tubulin Inhibitor|PD-1 Inhibitor","Yes","['Erdafitinib', 'Fibroblast', 'Vinflunine']","No",null,"Phase 3",4,631,"Anticipated","2018-03-23","2020-11-24","OS","Overall Survival",{"$nulls":3},"The purpose of this study is to evaluate efficacy of erdafitinib versus chemotherapy or pembrolizumab in participants with advanced urothelial cancer harboring selected fibroblast growth factor receptor (FGFR) aberrations who have progressed after one prior treatment.","A study of erdafitinib versus standard of care, consisting of chemotherapy (docetaxel or vinflunine) or PD1 agent pembrolizumab, in participants with advanced urothelial cancer and selected FGFR aberrations who have progressed on or after one prior line of systemic therapy. It will consist of screening, treatment phase (from randomization until disease progression, intolerable toxicity, withdrawal of consent or decision by investigator to discontinue treatment, post-treatment follow-up (from end-of-treatment to participants death, withdraws consent, lost to follow-up, or end of study, whichever comes first). Efficacy, pharmacokinetics, biomarkers, patient reported outcomes, medical resource utilization and safety will be assessed.","A Phase 3 Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Subjects With Advanced Urothelial Cancer and Selected FGFR Gene Aberrations","CR108401","Urothelial Cancer","Transitional Cell Carcinoma","Oncology Solid Tumor","Oncology","Experimental","Cohort 1 (Arm 1A): Erdafitinib|Cohort 1 (Arm 1B): Vinflunine or Docetaxel|Cohort 2 (Arm 2A): Erdafitinib|Cohort 2 (Arm 2B): Pembrolizumab","Participants will be screened based on Fibroblast Growth Factor Receptor inhibitor Clinical Trial Assay (FGFRi CTA) to determine molecular eligibility and participants who meet molecular eligibility criteria will be enrolled. Participants (treated with prior anti-anti-programmed cell death protein [PD][L]1 agent) will swallow erdafitinib tablets orally at a starting dose of 8 milligram (mg), once daily for 21 days in a 21-day cycle until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustment are based on phosphate level and observed toxicity (adverse events [AEs]).|Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be enrolled. Participants (treated with prior anti-PD[L]1 agent) will receive vinflunine 320 milligram per meter square (mg/m^2) as a 20-minute intravenous infusion once every 3 weeks or docetaxel 75 mg/m^2 as a 1 hour intravenous infusion every 3 weeks. Treatment with either agent (choice of investigator) will be administered until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustments are based on observed toxicities.|Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be enrolled. Participants (no prior treatment with anti-PD(L)1 agent) will swallow erdafitinib tablets orally at a starting dose of 8 mg, once daily for 21 days in a 21-day cycle until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustments are based on phosphate level and observed toxicity (AEs).|Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be enrolled. Participants (no prior treatment with anti-PD(L)1 agent) will receive pembrolizumab 200 mg as a 30-minute intravenous infusion once every 3 weeks, until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustments are based on observed toxicities.","Drug|Device","Erdafitinib|Fibroblast Growth Factor Receptor inhibitor Clinical Trial Assay (FGFRi CTA)|Vinflunine|Docetaxel|Pembrolizumab","Participants will swallow erdafitinib tablets orally at a starting dose of 8 mg.|FGFRi CTA will be used to determine molecular eligibility.|Participants will receive vinflunine 320 mg/m^2 as a 20-minute intravenous infusion.|Participants will receive docetaxel 75 mg/m^2 as a 1 hour intravenous infusion.|Participants will receive pembrolizumab 200 mg as a 30-minute intravenous infusion.","JNJ-42756493","Cohort 1 (Arm 1A): Erdafitinib|Cohort 1 (Arm 1B): Vinflunine or Docetaxel|Cohort 2 (Arm 2A): Erdafitinib|Cohort 2 (Arm 2B): Pembrolizumab","\n\n * Histologic demonstration of transitional cell carcinoma of the urothelium. Minor components ( less than [<] 50 percent [%] overall) of variant histology such as glandular or squamous differentiation, or evolution to more aggressive phenotypes such as sarcomatoid or micropapillary change are acceptable\n * Metastatic or surgically unresectable urothelial cancer\n * Documented progression of disease, defined as any progression that requires a change in treatment, prior to randomization\n * Only one line of prior systemic treatment for metastatic urothelial cancer. Participants who received neoadjuvant or adjuvant chemotherapy and showed disease progression (as defined above), within 12 months of the last dose are considered to have received systemic chemotherapy in the metastatic setting Cohort 1: prior chemotherapy and anti-PD(L)1 [in combination or in maintenance setting] (anti-PD(L)1 alone is allowed only for participants with documented cisplatin ineligibility) and Cohort 2: prior chemotherapy (no prior anti-PD(L)1 treatment)\n * A woman of childbearing potential who is sexually active must have a negative pregnancy test (beta human chorionic gonadotropin [beta hCG]) at Screening (urine or serum)\n * Participants must meet appropriate molecular eligibility criteria\n * Eastern Cooperative Oncology Group (ECOG) performance status Grade 0, 1, or 2\n * Adequate bone marrow, liver, and renal function\n\n","\n\n * Treatment with any other investigational agent or participation in another clinical study with therapeutic intent within 30 days prior to randomization\n * Active malignancies (that is, requiring treatment change in the last 24 months). The only allowed exceptions are: urothelial cancer, skin cancer treated within the last 24 months that is considered completely cured, localized prostate cancer with a gleason score of 6 (treated within the last 24 months or untreated and under surveillance) and localized prostate cancer with a gleason score of 3+4 that has been treated more than 12 months prior to full study screening and considered completely cured\n * Symptomatic central nervous system metastases\n * Received prior fibroblast growth factor receptor (FGFR) inhibitor treatment\n * Known allergies, hypersensitivity, or intolerance to erdafitinib or its excipients\n * Corneal or retinal abnormality likely to increase the risk of eye toxicity or lens conditions, such as untreated mature or hypermature senile cataract, affecting visual acuity that impair the ability to interpret the Amsler grid test\n * History of uncontrolled cardiovascular disease\n * Impaired wound healing capacity defined as skin/decubitus ulcers, chronic leg ulcers, known gastric ulcers, or unhealed incisions",{"$nulls":4},"Actual","2018-01-04","Actual","Anticipated","2021-05-27","Anticipated","2018-09-01","2017-12-20","2018-01-03","2018-09-21","Yes",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No",null,null,"URL: http://pam.sylogent.com/cr/CR108401 [http://pam.sylogent.com/cr/CR108401] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To learn how to participate in this trial please click here.",null,"Yes","Yes",{"$nulls":17},"2017-002932-18|42756493BLC3001","EudraCT Number|Janssen Research & Development, LLC","Overall Survival (OS)","Overall survival is measured from the date of randomization to the date of the participant's death. If the participant is alive or the vital status is unknown, the participant will be censored at the date the participant was last known to be alive.","Date of first randomization to the date of participant's death (approximately up to 3 years)","Progression-free Survival (PFS)|Overall Response Rate (ORR)|Time to Worsening in Symptom Items and Functioning Subscales in Patient-Reported Health Status of the Functional Assessment of Cancer Therapy-Bladder Cancer (FACT-Bl)|Change from Baseline in Patient-Global Impression of Severity (PGIS) Score|Change from Baseline in the Visual Analog Scale (VAS) of the EQ-5D-5L|Change from Baseline in the Utility Scale of the EQ-5D-5L|Duration of Response (DOR)|Number of Participants with Adverse Events (AEs) as a Measure of Safety|Oral Clearance (CL/F) of Erdafitinib|Area Under the Plasma Concentration-Time Curve from Time Zero to Time 't' (AUC[0-t]) of Erdafitinib","PFS is defined as duration in days from date of randomization to disease progression date (assessed per Response Evaluation Criteria in Solid Tumors Version 1.1|ORR is defined as the proportion of participants who achieve CR (CR; disappearance of all target lesions and disappearance of all non-target lesions and normalization of tumor marker level) or partial response (PR; at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters), as assessed per RECIST v1.1 by the investigator.|The FACT-Bl consists of 36 core items, with 5-point Likert response scales, covering 5 primary domains: Physical well-being, social/family well-being, emotional well-being, functional well-being and bladder symptom subscale. The answer scales range from \"Not at all (score=0)\" to \"very much (score=4)\" to assess the meaningful significant symptom deterioration.|The PGIS is a single question regarding the participant report of disease severity. Participants will be asked that ''considering all aspects of your bladder cancer symptoms right now, would you say your bladder cancer symptoms are none, mild, moderate, severe, or very severe?\" The PGIS is an anchor question that will be used to establish the magnitude of meaningful change in this study by assessing disease severity.|European Quality of Life 5 Dimensions (EQ-5D) visual analog scale (VAS) is a 20 centimeter (cm) vertical VAS with scores ranging from 0 (worst imaginable health) to 100 (perfect health). A higher score indicates an improvement in health in the Health Status Index.|The EuroQol-5 is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating \"full health\" and 0 representing dead.|DOR for responders is defined as duration in days from the date of initial documentation of a response to the date of first documented evidence of progressive disease (PD) or relapse for participants who experience CR (CR; disappearance of all target lesions and disappearance of all non-target lesions and normalization of tumor marker level) during the study or death.|An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.|CL/F is the oral clearance; that is clearance based on oral bioavailability of erdafitinib.|AUC(0-t) is the area under the plasma concentration-time curve from time zero to any time 't' of erdafitinib.","RECIST v1.1 by investigator) or relapse from CR or death, whichever is reported first. RECIST 1.1, progressive disease is defined as a 20 percent (%) increase in the sum of diameters of all target lesions and a minimum absolute increase of 5 millimeter (mm) in the sum. CR is defined as disappearance of all target lesions, non-target lesions and normalization of tumor marker level.|Approximately up to 3 years|Baseline up to end of treatment (approximately 3 years)|Baseline up to follow up phase (approximately 3 years)|From the date of initial documentation of a response to date of first documented evidence of progressive disease (or participants relapse who experience CR during the study) or death (approximately up to 3 years)|Day 14 (Cycle 1), Day 1 (Cycle 2) (each cycle is of 21 days)","JNJ.CT@sylogent.com","Study Contact","844-434-4210",{"$cut":{"chars":16731,"head":"Camperdown, Australia, 2050 Peninsula & South Eastern Haematology And Oncology GroupFrankston, Australia, 3199 Royal Hobart HospitalHobart, Australia, 7000 Peter Maccallum Cancer CentreMelbourne, Australia, 3000 Frankston HospitalMelbourne, Australia, 3199 Southside Cancer Care CentreMiranda, Australia, 2228 Sir Charles Gairdner HospitalNedlands, Australia, 6009|Graz, Austria, 8036 Krankenhaus Der Barmherzigen SchwesternLinz, Austria, 4010 Lkh - UniversitÃ¤tsklinikum Der Pmu SalzburgSalzburg, Austria, 5020 Medical University Vienna, MuvVienna, Austria, A-1090|Aalst, Belgium, 9300 Zna MiddelheimAntwerpen, Belgium, 2020 Cliniques Universitaires Saint-LucBrussel, Belgium, 1200 Clinique Notre Dame De GrÃ¢ceCharleroi, Belgium, 6000 Az Maria MiddelaresGent, Belgium, 9000 Universitair Ziekenhuis GentGent, Belgium, 9000 Chc-Cliniques Saint-JosephLiÃ¨ge, Belgium, 4000 Sint-Augustinus AzWilrijk, Belgium, 2610 Chu Dinant Godinne Ucl NamurYvoir, Belgium, 5530|Barretos, Brazil, 14784-400 AssociaÃ§Ã£o MÃ¡rio Penna\\NÃºcleo De Ensino E PesquisasBelo Horizonte, Brazil, 30380-472 Hospital Erasto GaertnerCuritiba, Brazil, 81520-060 ClÃ­nica De Neoplasias Litoral Ltda.Itajai, Brazil, 88301-220 Upco - HcpaPorto Alegre, Brazil, 90035-903 Inca - Instituto Nacional Do CancerRio De Janeiro, Brazil, 20231-050 Fundacao Antonio PrudenteSao Paulo, Brazil, 01509900 Hospital De Base De SÃ£o JosÃ© Do Rio PretoSÃ£o JosÃ© Do Rio Preto, Brazil, 15090-000 Sociedade Beneficiante De Senhoras - Hospital Sirio LibanesSÃ£o Paulo, Brazil, 01308901 Cepho - Faculdade De Medicina Do AbcSÃ£o Paulo, Brazil, 09060-650|Kelowna, British Columbia, Canada, V1Y 5L3 Vancouver Cancer CentreVancouver, British Columbia, Canada, V5Z 4E6|Winnipeg, Manitoba, Canada, R3E 0V9|Thunder Bay, Ontario, Canada, P7B 6V4 Princess Margaret Hospital- UhnToronto, Ontario, Canada, M5G 2M9|Regina, Saskatchewan, Canada, S4T 7T1|Beijing, China, 100034 Beijing Friendship HospitalBeijing, China, 100050 Peking University Third HospitalBeijing, China, 100191 Beijing HospitalBeijing, China, 100730 Peking Union Medical College HospitalBeijing, China, 100730 Sichuan Provincial People'S HospitalChengdu, China, 610000 Sun Yat-Sen Memorial Hospital, Sun Yat-Sen UniversityGuangzhou, China, 510120 Guangzhou First Municipal People'S HospitalGuangzhou, China, 510180 Zhejiang Provincial People'S HospitalHangzhou, China, 310000 Sir Run Run Shaw Hospital, Zhejiang UniversityHangzhou, China, 310020 The First Affliated Hospital Of Nanchang UniversityNanchang, China, 330006 Nanjing Drum Tower HospitalNanjing, China, 210008 Jiangsu Cancer HospitalNanjing, China, 210009 Renji Hospital, Shanghai Jiaotong University School Of MedicineShanghai, China, 200127 Huadong Hospital Affiliated To Fudan UniversityShanghai, China, 200400 First Affiliated Hospital, Xi'An Jiaotong UniversityXi'An, China, 710061|Angers, France, 49055 Hopital Jean MinjozBesancon Cedex, France, 25030 Institut BergoniÃ©Bordeaux, France, 33000 Centre Jean PerrinClermont Ferrand, France, 63011 Centre Georges-FranÃ§ois LeclercDijon, France, 21079 Centre Oscar LambretLille, France, 59020 Centre Leon BÃ©rardLyon, France, 69008 Hopital De La TimoneMarseille, France, 13005 Institut Regional Du Cancer De Montpellier Val D'AurelleMontpellier, France, 34298 Centre Antoine LacassagneNice, France, 06189 Institut De CancÃ©rologie Du GardNÃ®mes, France, 30029 Hospital Saint-LouisParis Cedex 10, France, 75475 Hopital Europeen Georges-PompidouParis, France, 75015 Hospices Civils De Lyon HclPierre-BÃ©nite, France, 69495 Chu De PoitiersPoitiers Cedex, France, 86021 Centre Hopitalier Inter-Communal De CornouailleQuimper, France, 2900 Centre Eugene MarquisRennes Cedex, France, 35062 I.C.O. RenÃ© GauducheauSaint Herblain Cedex, France, 44805 Institut De CancÃ©rologie De LoireSaint-Priest-En-Jarez, France, 42271 Hopitaux Universitaires De StrasbourgStrasbourg, France, 67091 Institut Claudius RegaudToulouse, France, 31059 Institut Gustave RoussyVillejuif, France, 94805|Berlin, Germany, 10967 Universitatsklinikum Carl Gustav Carcus DresdenDresden, Germany, 01307 Universitaetsk"}},"Alaska|Arizona|California|Colorado|Florida|Georgia|Idaho|Illinois|Kentucky|Michigan|Nebraska|Nevada|New York|North Carolina|Pennsylvania|South Carolina|Texas|Virginia|Washington","Australia|Austria|Belgium|Brazil|Canada|China|France|Germany|Greece|Hungary|India|Israel|Italy|Japan|Mexico|Netherlands|Portugal|Spain|Turkey|Ukraine|United Kingdom|United States","Chris O'Brien Lifehouse|Lkh-Univ. Klinikum Graz|Olv Ziekenhuis Aalst|Fundacao Pio Xii - Hospital De Cancer De Barretos|British Columbia Bc Cancer Agency - Southern Interior|Manitoba Cancercare Manitoba|Ontario Thunder Bay Regional Health Sciences Centre|Saskatchewan Saskatchewan Cancer Agency (Sca) - Allan Blair Cancer Centre|Peking University First Hospital|Institut De CancÃ©rologie De L'Ouest (Ico)|Vivantes Klinikum Am Urban|University General Hospital Of Rio Patras|Semmelweis Egyetem|Manipal Comprehensive Cancer Centre, Manipal Hospital|Rambam Health Care Campus|Azienda Ospedaliera Nazionale Ss. Antonio E Biagio E Cesare Arrigo Alessandria|Chiba Cancer Center|San Peregrino Cancer Center|St. Antonius Ziekenhuis Nieuwegein|Hospital LusÃ­adas|Hosp. Univ. Infanta Cristina|Adana Baskent Practice And Research Hospital|Chernivtsi Regional Clinical Hospital|University Hospitals Bristol - Bristol Haematology & Oncolog|Alaska Urological Institute Dba Alaska Clinical Research Center|University Of Ua Cancer Center(Uacc)/Dh-Sjhmc|University Of California Irvine Medical Center - Chao Family Comprehensive Cancer Center|Uchealth Anschutz Cancer Pavilion|University Of Miami/Sylvester Cancer Center|Piedmont Cancer Institute|St. Luke's Meridian Medical Center|Northwestern University|Norton Cancer Institute|University Of Michigan Health System|University Of Nebraska Medical Center|Va Medical Center|Montefiore Medical Center|Levine Cancer Institute, Carolinas Healthcare System|Penn State Hershey Cancer Institute|University Of Missouri|The Center For Cancer And Blood Disorders|Inova Dwiight &Martha Schar Cancer Institute|Seattle Cancer Care Alliance",{"$nulls":3},"Janssen Research & Development, LLC Clinical Trials","2018-09-21","2020-05-25T16:35:12.899","2020-05-26T17:10:42.972","NCT03390504"]
["5ecbf3c0fe30261b1a04819d","NCT03390504","2018-10-19","Johnson & Johnson","JNJ","Recruiting","A Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Participants With Advanced Urothelial Cancer and Selected Fibroblast Growth Factor Receptor (FGFR) Gene Aberrations","Erdafitinib|Fibroblast|Vinflunine|Docetaxel|Pembrolizumab","FGFR Antagonist|Tubulin Inhibitor|Mitosis Inhibitor|Tubulin Inhibitor|PD-1 Inhibitor","Yes","['Erdafitinib', 'Fibroblast', 'Vinflunine']","No",null,"Phase 3",4,631,"Anticipated","2018-03-23","2020-11-24","OS","Overall Survival",{"$nulls":3},"The purpose of this study is to evaluate efficacy of erdafitinib versus chemotherapy or pembrolizumab in participants with advanced urothelial cancer harboring selected fibroblast growth factor receptor (FGFR) aberrations who have progressed after one prior treatment.","A study of erdafitinib versus standard of care, consisting of chemotherapy (docetaxel or vinflunine) or PD1 agent pembrolizumab, in participants with advanced urothelial cancer and selected FGFR aberrations who have progressed on or after one prior line of systemic therapy. It will consist of screening, treatment phase (from randomization until disease progression, intolerable toxicity, withdrawal of consent or decision by investigator to discontinue treatment, post-treatment follow-up (from end-of-treatment to participants death, withdraws consent, lost to follow-up, or end of study, whichever comes first). Efficacy, pharmacokinetics, biomarkers, patient reported outcomes, medical resource utilization and safety will be assessed.","A Phase 3 Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Subjects With Advanced Urothelial Cancer and Selected FGFR Gene Aberrations","CR108401","Urothelial Cancer","Transitional Cell Carcinoma","Oncology Solid Tumor","Oncology","Experimental","Cohort 1 (Arm 1A): Erdafitinib|Cohort 1 (Arm 1B): Vinflunine or Docetaxel|Cohort 2 (Arm 2A): Erdafitinib|Cohort 2 (Arm 2B): Pembrolizumab","Participants will be screened based on Fibroblast Growth Factor Receptor inhibitor Clinical Trial Assay (FGFRi CTA) to determine molecular eligibility and participants who meet molecular eligibility criteria will be enrolled. Participants (treated with prior anti-anti-programmed cell death protein [PD][L]1 agent) will swallow erdafitinib tablets orally at a starting dose of 8 milligram (mg), once daily for 21 days in a 21-day cycle until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustment are based on phosphate level and observed toxicity (adverse events [AEs]).|Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be enrolled. Participants (treated with prior anti-PD[L]1 agent) will receive vinflunine 320 milligram per meter square (mg/m^2) as a 20-minute intravenous infusion once every 3 weeks or docetaxel 75 mg/m^2 as a 1 hour intravenous infusion every 3 weeks. Treatment with either agent (choice of investigator) will be administered until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustments are based on observed toxicities.|Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be enrolled. Participants (no prior treatment with anti-PD(L)1 agent) will swallow erdafitinib tablets orally at a starting dose of 8 mg, once daily for 21 days in a 21-day cycle until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustments are based on phosphate level and observed toxicity (AEs).|Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be enrolled. Participants (no prior treatment with anti-PD(L)1 agent) will receive pembrolizumab 200 mg as a 30-minute intravenous infusion once every 3 weeks, until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustments are based on observed toxicities.","Drug|Device","Erdafitinib|Fibroblast Growth Factor Receptor inhibitor Clinical Trial Assay (FGFRi CTA)|Vinflunine|Docetaxel|Pembrolizumab","Participants will swallow erdafitinib tablets orally at a starting dose of 8 mg.|FGFRi CTA will be used to determine molecular eligibility.|Participants will receive vinflunine 320 mg/m^2 as a 20-minute intravenous infusion.|Participants will receive docetaxel 75 mg/m^2 as a 1 hour intravenous infusion.|Participants will receive pembrolizumab 200 mg as a 30-minute intravenous infusion.","JNJ-42756493","Cohort 1 (Arm 1A): Erdafitinib|Cohort 1 (Arm 1B): Vinflunine or Docetaxel|Cohort 2 (Arm 2A): Erdafitinib|Cohort 2 (Arm 2B): Pembrolizumab","\n\n * Histologic demonstration of transitional cell carcinoma of the urothelium. Minor components ( less than [<] 50 percent [%] overall) of variant histology such as glandular or squamous differentiation, or evolution to more aggressive phenotypes such as sarcomatoid or micropapillary change are acceptable\n * Metastatic or surgically unresectable urothelial cancer\n * Documented progression of disease, defined as any progression that requires a change in treatment, prior to randomization\n * Only one line of prior systemic treatment for metastatic urothelial cancer. Participants who received neoadjuvant or adjuvant chemotherapy and showed disease progression (as defined above), within 12 months of the last dose are considered to have received systemic chemotherapy in the metastatic setting Cohort 1: prior chemotherapy and anti-PD(L)1 [in combination or in maintenance setting] (anti-PD(L)1 alone is allowed only for participants with documented cisplatin ineligibility) and Cohort 2: prior chemotherapy (no prior anti-PD(L)1 treatment)\n * A woman of childbearing potential who is sexually active must have a negative pregnancy test (beta human chorionic gonadotropin [beta hCG]) at Screening (urine or serum)\n * Participants must meet appropriate molecular eligibility criteria\n * Eastern Cooperative Oncology Group (ECOG) performance status Grade 0, 1, or 2\n * Adequate bone marrow, liver, and renal function\n\n","\n\n * Treatment with any other investigational agent or participation in another clinical study with therapeutic intent within 30 days prior to randomization\n * Active malignancies (that is, requiring treatment change in the last 24 months). The only allowed exceptions are: urothelial cancer, skin cancer treated within the last 24 months that is considered completely cured, localized prostate cancer with a gleason score of 6 (treated within the last 24 months or untreated and under surveillance) and localized prostate cancer with a gleason score of 3+4 that has been treated more than 12 months prior to full study screening and considered completely cured\n * Symptomatic central nervous system metastases\n * Received prior fibroblast growth factor receptor (FGFR) inhibitor treatment\n * Known allergies, hypersensitivity, or intolerance to erdafitinib or its excipients\n * Corneal or retinal abnormality likely to increase the risk of eye toxicity or lens conditions, such as untreated mature or hypermature senile cataract, affecting visual acuity that impair the ability to interpret the Amsler grid test\n * History of uncontrolled cardiovascular disease\n * Impaired wound healing capacity defined as skin/decubitus ulcers, chronic leg ulcers, known gastric ulcers, or unhealed incisions",{"$nulls":4},"Actual","2018-01-04","Actual","Anticipated","2021-05-27","Anticipated","2018-10-01","2017-12-20","2018-01-03","2018-10-18","Yes",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No",null,null,"URL: http://pam.sylogent.com/cr/CR108401 [http://pam.sylogent.com/cr/CR108401] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To learn how to participate in this trial please click here.",null,"Yes","Yes",{"$nulls":17},"2017-002932-18|42756493BLC3001","EudraCT Number|Janssen Research & Development, LLC","Overall Survival (OS)","Overall survival is measured from the date of randomization to the date of the participant's death. If the participant is alive or the vital status is unknown, the participant will be censored at the date the participant was last known to be alive.","Date of first randomization to the date of participant's death (approximately up to 3 years)","Progression-free Survival (PFS)|Overall Response Rate (ORR)|Time to Worsening in Symptom Items and Functioning Subscales in Patient-Reported Health Status of the Functional Assessment of Cancer Therapy-Bladder Cancer (FACT-Bl)|Change from Baseline in Patient-Global Impression of Severity (PGIS) Score|Change from Baseline in the Visual Analog Scale (VAS) of the EQ-5D-5L|Change from Baseline in the Utility Scale of the EQ-5D-5L|Duration of Response (DOR)|Number of Participants with Adverse Events (AEs) as a Measure of Safety|Oral Clearance (CL/F) of Erdafitinib|Area Under the Plasma Concentration-Time Curve from Time Zero to Time 't' (AUC[0-t]) of Erdafitinib","PFS is defined as duration in days from date of randomization to disease progression date (assessed per Response Evaluation Criteria in Solid Tumors Version 1.1|ORR is defined as the proportion of participants who achieve CR (CR; disappearance of all target lesions and disappearance of all non-target lesions and normalization of tumor marker level) or partial response (PR; at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters), as assessed per RECIST v1.1 by the investigator.|The FACT-Bl consists of 36 core items, with 5-point Likert response scales, covering 5 primary domains: Physical well-being, social/family well-being, emotional well-being, functional well-being and bladder symptom subscale. The answer scales range from \"Not at all (score=0)\" to \"very much (score=4)\" to assess the meaningful significant symptom deterioration.|The PGIS is a single question regarding the participant report of disease severity. Participants will be asked that ''considering all aspects of your bladder cancer symptoms right now, would you say your bladder cancer symptoms are none, mild, moderate, severe, or very severe?\" The PGIS is an anchor question that will be used to establish the magnitude of meaningful change in this study by assessing disease severity.|European Quality of Life 5 Dimensions (EQ-5D) visual analog scale (VAS) is a 20 centimeter (cm) vertical VAS with scores ranging from 0 (worst imaginable health) to 100 (perfect health). A higher score indicates an improvement in health in the Health Status Index.|The EuroQol-5 is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating \"full health\" and 0 representing dead.|DOR for responders is defined as duration in days from the date of initial documentation of a response to the date of first documented evidence of progressive disease (PD) or relapse for participants who experience CR (CR; disappearance of all target lesions and disappearance of all non-target lesions and normalization of tumor marker level) during the study or death.|An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.|CL/F is the oral clearance; that is clearance based on oral bioavailability of erdafitinib.|AUC(0-t) is the area under the plasma concentration-time curve from time zero to any time 't' of erdafitinib.","RECIST v1.1 by investigator) or relapse from CR or death, whichever is reported first. RECIST 1.1, progressive disease is defined as a 20 percent (%) increase in the sum of diameters of all target lesions and a minimum absolute increase of 5 millimeter (mm) in the sum. CR is defined as disappearance of all target lesions, non-target lesions and normalization of tumor marker level.|Approximately up to 3 years|Baseline up to end of treatment (approximately 3 years)|Baseline up to follow up phase (approximately 3 years)|From the date of initial documentation of a response to date of first documented evidence of progressive disease (or participants relapse who experience CR during the study) or death (approximately up to 3 years)|Day 14 (Cycle 1), Day 1 (Cycle 2) (each cycle is of 21 days)","JNJ.CT@sylogent.com","Study Contact","844-434-4210",{"$cut":{"chars":16776,"head":"Camperdown, Australia, 2050 Peninsula & South Eastern Haematology And Oncology GroupFrankston, Australia, 3199 Royal Hobart HospitalHobart, Australia, 7000 Peter Maccallum Cancer CentreMelbourne, Australia, 3000 Frankston HospitalMelbourne, Australia, 3199 Southside Cancer Care CentreMiranda, Australia, 2228 Sir Charles Gairdner HospitalNedlands, Australia, 6009|Graz, Austria, 8036 Krankenhaus Der Barmherzigen SchwesternLinz, Austria, 4010 Lkh - UniversitÃ¤tsklinikum Der Pmu SalzburgSalzburg, Austria, 5020 Medical University Vienna, MuvVienna, Austria, A-1090|Aalst, Belgium, 9300 Zna MiddelheimAntwerpen, Belgium, 2020 Cliniques Universitaires Saint-LucBrussel, Belgium, 1200 Clinique Notre Dame De GrÃ¢ceCharleroi, Belgium, 6000 Az Maria MiddelaresGent, Belgium, 9000 Universitair Ziekenhuis GentGent, Belgium, 9000 Chc-Cliniques Saint-JosephLiÃ¨ge, Belgium, 4000 Sint-Augustinus AzWilrijk, Belgium, 2610 Chu Dinant Godinne Ucl NamurYvoir, Belgium, 5530|Barretos, Brazil, 14784-400 AssociaÃ§Ã£o MÃ¡rio Penna\\NÃºcleo De Ensino E PesquisasBelo Horizonte, Brazil, 30380-472 Hospital Erasto GaertnerCuritiba, Brazil, 81520-060 ClÃ­nica De Neoplasias Litoral Ltda.Itajai, Brazil, 88301-220 Upco - HcpaPorto Alegre, Brazil, 90035-903 Inca - Instituto Nacional Do CancerRio De Janeiro, Brazil, 20231-050 Fundacao Antonio PrudenteSao Paulo, Brazil, 01509900 Hospital De Base De SÃ£o JosÃ© Do Rio PretoSÃ£o JosÃ© Do Rio Preto, Brazil, 15090-000 Sociedade Beneficiante De Senhoras - Hospital Sirio LibanesSÃ£o Paulo, Brazil, 01308901 Cepho - Faculdade De Medicina Do AbcSÃ£o Paulo, Brazil, 09060-650|Kelowna, British Columbia, Canada, V1Y 5L3 Vancouver Cancer CentreVancouver, British Columbia, Canada, V5Z 4E6|Winnipeg, Manitoba, Canada, R3E 0V9|Thunder Bay, Ontario, Canada, P7B 6V4 Princess Margaret Hospital- UhnToronto, Ontario, Canada, M5G 2M9|Regina, Saskatchewan, Canada, S4T 7T1|Beijing, China, 100034 Beijing Friendship HospitalBeijing, China, 100050 Peking University Third HospitalBeijing, China, 100191 Beijing HospitalBeijing, China, 100730 Peking Union Medical College HospitalBeijing, China, 100730 Sichuan Provincial People'S HospitalChengdu, China, 610000 Sun Yat-Sen Memorial Hospital, Sun Yat-Sen UniversityGuangzhou, China, 510120 Guangzhou First Municipal People'S HospitalGuangzhou, China, 510180 Zhejiang Provincial People'S HospitalHangzhou, China, 310000 Sir Run Run Shaw Hospital, Zhejiang UniversityHangzhou, China, 310020 The First Affliated Hospital Of Nanchang UniversityNanchang, China, 330006 Nanjing Drum Tower HospitalNanjing, China, 210008 Jiangsu Cancer HospitalNanjing, China, 210009 Renji Hospital, Shanghai Jiaotong University School Of MedicineShanghai, China, 200127 Huadong Hospital Affiliated To Fudan UniversityShanghai, China, 200400 First Affiliated Hospital, Xi'An Jiaotong UniversityXi'An, China, 710061|Angers, France, 49055 Hopital Jean MinjozBesancon Cedex, France, 25030 Institut BergoniÃ©Bordeaux, France, 33000 Centre Jean PerrinClermont Ferrand, France, 63011 Centre Georges-FranÃ§ois LeclercDijon, France, 21079 Centre Oscar LambretLille, France, 59020 Centre Leon BÃ©rardLyon, France, 69008 Hopital De La TimoneMarseille, France, 13005 Institut Regional Du Cancer De Montpellier Val D'AurelleMontpellier, France, 34298 Centre Antoine LacassagneNice, France, 06189 Institut De CancÃ©rologie Du GardNÃ®mes, France, 30029 Hospital Saint-LouisParis Cedex 10, France, 75475 Hopital Europeen Georges-PompidouParis, France, 75015 Hospices Civils De Lyon HclPierre-BÃ©nite, France, 69495 Chu De PoitiersPoitiers Cedex, France, 86021 Centre Hopitalier Inter-Communal De CornouailleQuimper, France, 2900 Centre Eugene MarquisRennes Cedex, France, 35062 I.C.O. RenÃ© GauducheauSaint Herblain Cedex, France, 44805 Institut De CancÃ©rologie De LoireSaint-Priest-En-Jarez, France, 42271 Hopitaux Universitaires De StrasbourgStrasbourg, France, 67091 Institut Claudius RegaudToulouse, France, 31059 Institut Gustave RoussyVillejuif, France, 94805|Berlin, Germany, 10967 Universitatsklinikum Carl Gustav Carcus DresdenDresden, Germany, 01307 Universitaetsk"}},"Alaska|Arizona|California|Colorado|Florida|Georgia|Idaho|Illinois|Kentucky|Michigan|Nebraska|Nevada|New York|North Carolina|Pennsylvania|South Carolina|Texas|Virginia|Washington","Australia|Austria|Belgium|Brazil|Canada|China|France|Germany|Greece|Hungary|India|Israel|Italy|Japan|Mexico|Netherlands|Portugal|Spain|Turkey|Ukraine|United Kingdom|United States","Chris O'Brien Lifehouse|Lkh-Univ. Klinikum Graz|Olv Ziekenhuis Aalst|Fundacao Pio Xii - Hospital De Cancer De Barretos|British Columbia Bc Cancer Agency - Southern Interior|Manitoba Cancercare Manitoba|Ontario Thunder Bay Regional Health Sciences Centre|Saskatchewan Saskatchewan Cancer Agency (Sca) - Allan Blair Cancer Centre|Peking University First Hospital|Institut De CancÃ©rologie De L'Ouest (Ico)|Vivantes Klinikum Am Urban|University General Hospital Of Rio Patras|Semmelweis Egyetem|Manipal Comprehensive Cancer Centre, Manipal Hospital|Rambam Health Care Campus|Azienda Ospedaliera Nazionale Ss. Antonio E Biagio E Cesare Arrigo Alessandria|Chiba Cancer Center|San Peregrino Cancer Center|St. Antonius Ziekenhuis Nieuwegein|Hospital LusÃ­adas|Hosp. Univ. Infanta Cristina|Adana Baskent Practice And Research Hospital|Chernivtsi Regional Clinical Hospital|University Hospitals Bristol - Bristol Haematology & Oncolog|Alaska Urological Institute Dba Alaska Clinical Research Center|University Of Ua Cancer Center(Uacc)/Dh-Sjhmc|University Of California Irvine Medical Center - Chao Family Comprehensive Cancer Center|Uchealth Anschutz Cancer Pavilion|University Of Miami/Sylvester Cancer Center|Piedmont Cancer Institute|St. Luke's Meridian Medical Center|Northwestern University|Norton Cancer Institute|University Of Michigan Health System|University Of Nebraska Medical Center|Va Medical Center|Montefiore Medical Center|Levine Cancer Institute, Carolinas Healthcare System|Penn State Hershey Cancer Institute|University Of Missouri|The Center For Cancer And Blood Disorders|Inova Dwiight &Martha Schar Cancer Institute|Seattle Cancer Care Alliance",{"$nulls":3},"Janssen Research & Development, LLC Clinical Trials","2018-10-18","2020-05-25T16:35:12.357","2020-05-26T17:10:42.972","NCT03390504"]
["5ecbf3c0feab101b155307cd","NCT03390504","2018-11-15","Johnson & Johnson","JNJ","Recruiting","A Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Participants With Advanced Urothelial Cancer and Selected Fibroblast Growth Factor Receptor (FGFR) Gene Aberrations","Erdafitinib|Fibroblast|Vinflunine|Docetaxel|Pembrolizumab","FGFR Antagonist|Tubulin Inhibitor|Mitosis Inhibitor|Tubulin Inhibitor|PD-1 Inhibitor","Yes","['Erdafitinib', 'Fibroblast', 'Vinflunine']","No",null,"Phase 3",4,631,"Anticipated","2018-03-23","2020-11-24","OS","Overall Survival",{"$nulls":3},"The purpose of this study is to evaluate efficacy of erdafitinib versus chemotherapy or pembrolizumab in participants with advanced urothelial cancer harboring selected fibroblast growth factor receptor (FGFR) aberrations who have progressed after one prior treatment.","A study of erdafitinib versus standard of care, consisting of chemotherapy (docetaxel or vinflunine) or PD1 agent pembrolizumab, in participants with advanced urothelial cancer and selected FGFR aberrations who have progressed on or after one prior line of systemic therapy. It will consist of screening, treatment phase (from randomization until disease progression, intolerable toxicity, withdrawal of consent or decision by investigator to discontinue treatment, post-treatment follow-up (from end-of-treatment to participants death, withdraws consent, lost to follow-up, or end of study, whichever comes first). Efficacy, pharmacokinetics, biomarkers, patient reported outcomes, medical resource utilization and safety will be assessed.","A Phase 3 Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Subjects With Advanced Urothelial Cancer and Selected FGFR Gene Aberrations","CR108401","Urothelial Cancer","Transitional Cell Carcinoma","Oncology Solid Tumor","Oncology","Experimental","Cohort 1 (Arm 1A): Erdafitinib|Cohort 1 (Arm 1B): Vinflunine or Docetaxel|Cohort 2 (Arm 2A): Erdafitinib|Cohort 2 (Arm 2B): Pembrolizumab","Participants will be screened based on Fibroblast Growth Factor Receptor inhibitor Clinical Trial Assay (FGFRi CTA) to determine molecular eligibility and participants who meet molecular eligibility criteria will be enrolled. Participants (treated with prior anti-anti-programmed cell death protein [PD][L]1 agent) will swallow erdafitinib tablets orally at a starting dose of 8 milligram (mg), once daily for 21 days in a 21-day cycle until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustment are based on phosphate level and observed toxicity (adverse events [AEs]).|Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be enrolled. Participants (treated with prior anti-PD[L]1 agent) will receive vinflunine 320 milligram per meter square (mg/m^2) as a 20-minute intravenous infusion once every 3 weeks or docetaxel 75 mg/m^2 as a 1 hour intravenous infusion every 3 weeks. Treatment with either agent (choice of investigator) will be administered until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustments are based on observed toxicities.|Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be enrolled. Participants (no prior treatment with anti-PD(L)1 agent) will swallow erdafitinib tablets orally at a starting dose of 8 mg, once daily for 21 days in a 21-day cycle until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustments are based on phosphate level and observed toxicity (AEs).|Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be enrolled. Participants (no prior treatment with anti-PD(L)1 agent) will receive pembrolizumab 200 mg as a 30-minute intravenous infusion once every 3 weeks, until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustments are based on observed toxicities.","Drug|Device","Erdafitinib|Fibroblast Growth Factor Receptor inhibitor Clinical Trial Assay (FGFRi CTA)|Vinflunine|Docetaxel|Pembrolizumab","Participants will swallow erdafitinib tablets orally at a starting dose of 8 mg.|FGFRi CTA will be used to determine molecular eligibility.|Participants will receive vinflunine 320 mg/m^2 as a 20-minute intravenous infusion.|Participants will receive docetaxel 75 mg/m^2 as a 1 hour intravenous infusion.|Participants will receive pembrolizumab 200 mg as a 30-minute intravenous infusion.","JNJ-42756493","Cohort 1 (Arm 1A): Erdafitinib|Cohort 1 (Arm 1B): Vinflunine or Docetaxel|Cohort 2 (Arm 2A): Erdafitinib|Cohort 2 (Arm 2B): Pembrolizumab","\n\n * Histologic demonstration of transitional cell carcinoma of the urothelium. Minor components ( less than [<] 50 percent [%] overall) of variant histology such as glandular or squamous differentiation, or evolution to more aggressive phenotypes such as sarcomatoid or micropapillary change are acceptable\n * Metastatic or surgically unresectable urothelial cancer\n * Documented progression of disease, defined as any progression that requires a change in treatment, prior to randomization\n * Only one line of prior systemic treatment for metastatic urothelial cancer. Participants who received neoadjuvant or adjuvant chemotherapy and showed disease progression (as defined above), within 12 months of the last dose are considered to have received systemic chemotherapy in the metastatic setting Cohort 1: prior chemotherapy and anti-PD(L)1 [in combination or in maintenance setting] (anti-PD(L)1 alone is allowed only for participants with documented cisplatin ineligibility) and Cohort 2: prior chemotherapy (no prior anti-PD(L)1 treatment)\n * A woman of childbearing potential who is sexually active must have a negative pregnancy test (beta human chorionic gonadotropin [beta hCG]) at Screening (urine or serum)\n * Participants must meet appropriate molecular eligibility criteria\n * Eastern Cooperative Oncology Group (ECOG) performance status Grade 0, 1, or 2\n * Adequate bone marrow, liver, and renal function\n\n","\n\n * Treatment with any other investigational agent or participation in another clinical study with therapeutic intent within 30 days prior to randomization\n * Active malignancies (that is, requiring treatment change in the last 24 months). The only allowed exceptions are: urothelial cancer, skin cancer treated within the last 24 months that is considered completely cured, localized prostate cancer with a gleason score of 6 (treated within the last 24 months or untreated and under surveillance) and localized prostate cancer with a gleason score of 3+4 that has been treated more than 12 months prior to full study screening and considered completely cured\n * Symptomatic central nervous system metastases\n * Received prior fibroblast growth factor receptor (FGFR) inhibitor treatment\n * Known allergies, hypersensitivity, or intolerance to erdafitinib or its excipients\n * Corneal or retinal abnormality likely to increase the risk of eye toxicity or lens conditions, such as untreated mature or hypermature senile cataract, affecting visual acuity that impair the ability to interpret the Amsler grid test\n * History of uncontrolled cardiovascular disease\n * Impaired wound healing capacity defined as skin/decubitus ulcers, chronic leg ulcers, known gastric ulcers, or unhealed incisions",{"$nulls":4},"Actual","2018-01-04","Actual","Anticipated","2021-02-01","Anticipated","2018-11-01","2017-12-20","2018-01-03","2018-11-14","Yes",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No",null,null,"URL: http://pam.sylogent.com/cr/CR108401 [http://pam.sylogent.com/cr/CR108401] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To learn how to participate in this trial please click here.",null,"Yes","Yes",{"$nulls":17},"2017-002932-18|42756493BLC3001","EudraCT Number|Janssen Research & Development, LLC","Overall Survival (OS)","Overall survival is measured from the date of randomization to the date of the participant's death. If the participant is alive or the vital status is unknown, the participant will be censored at the date the participant was last known to be alive.","Date of first randomization to the date of participant's death (approximately up to 3 years)","Progression-free Survival (PFS)|Overall Response Rate (ORR)|Time to Worsening in Symptom Items and Functioning Subscales in Patient-Reported Health Status of the Functional Assessment of Cancer Therapy-Bladder Cancer (FACT-Bl)|Change from Baseline in Patient-Global Impression of Severity (PGIS) Score|Change from Baseline in the Visual Analog Scale (VAS) of the EQ-5D-5L|Change from Baseline in the Utility Scale of the EQ-5D-5L|Duration of Response (DOR)|Number of Participants with Adverse Events (AEs) as a Measure of Safety|Oral Clearance (CL/F) of Erdafitinib|Area Under the Plasma Concentration-Time Curve from Time Zero to Time 't' (AUC[0-t]) of Erdafitinib","PFS is defined as duration in days from date of randomization to disease progression date (assessed per Response Evaluation Criteria in Solid Tumors Version 1.1|ORR is defined as the proportion of participants who achieve CR (CR; disappearance of all target lesions and disappearance of all non-target lesions and normalization of tumor marker level) or partial response (PR; at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters), as assessed per RECIST v1.1 by the investigator.|The FACT-Bl consists of 36 core items, with 5-point Likert response scales, covering 5 primary domains: Physical well-being, social/family well-being, emotional well-being, functional well-being and bladder symptom subscale. The answer scales range from \"Not at all (score=0)\" to \"very much (score=4)\" to assess the meaningful significant symptom deterioration.|The PGIS is a single question regarding the participant report of disease severity. Participants will be asked that ''considering all aspects of your bladder cancer symptoms right now, would you say your bladder cancer symptoms are none, mild, moderate, severe, or very severe?\" The PGIS is an anchor question that will be used to establish the magnitude of meaningful change in this study by assessing disease severity.|European Quality of Life 5 Dimensions (EQ-5D) visual analog scale (VAS) is a 20 centimeter (cm) vertical VAS with scores ranging from 0 (worst imaginable health) to 100 (perfect health). A higher score indicates an improvement in health in the Health Status Index.|The EuroQol-5 is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating \"full health\" and 0 representing dead.|DOR for responders is defined as duration in days from the date of initial documentation of a response to the date of first documented evidence of progressive disease (PD) or relapse for participants who experience CR (CR; disappearance of all target lesions and disappearance of all non-target lesions and normalization of tumor marker level) during the study or death.|An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.|CL/F is the oral clearance; that is clearance based on oral bioavailability of erdafitinib.|AUC(0-t) is the area under the plasma concentration-time curve from time zero to any time 't' of erdafitinib.","RECIST v1.1 by investigator) or relapse from CR or death, whichever is reported first. RECIST 1.1, progressive disease is defined as a 20 percent (%) increase in the sum of diameters of all target lesions and a minimum absolute increase of 5 millimeter (mm) in the sum. CR is defined as disappearance of all target lesions, non-target lesions and normalization of tumor marker level.|Approximately up to 3 years|Baseline up to end of treatment (approximately 3 years)|Baseline up to follow up phase (approximately 3 years)|From the date of initial documentation of a response to date of first documented evidence of progressive disease (or participants relapse who experience CR during the study) or death (approximately up to 3 years)|Day 14 (Cycle 1), Day 1 (Cycle 2) (each cycle is of 21 days)","JNJ.CT@sylogent.com","Study Contact","844-434-4210",{"$cut":{"chars":16848,"head":"Camperdown, Australia, 2050 Peninsula & South Eastern Haematology And Oncology GroupFrankston, Australia, 3199 Royal Hobart HospitalHobart, Australia, 7000 Peter Maccallum Cancer CentreMelbourne, Australia, 3000 Frankston HospitalMelbourne, Australia, 3199 Southside Cancer Care CentreMiranda, Australia, 2228 Sir Charles Gairdner HospitalNedlands, Australia, 6009|Graz, Austria, 8036 Krankenhaus Der Barmherzigen SchwesternLinz, Austria, 4010 Lkh - UniversitÃ¤tsklinikum Der Pmu SalzburgSalzburg, Austria, 5020 Medical University Vienna, MuvVienna, Austria, A-1090|Aalst, Belgium, 9300 Zna MiddelheimAntwerpen, Belgium, 2020 Cliniques Universitaires Saint-LucBrussel, Belgium, 1200 Clinique Notre Dame De GrÃ¢ceCharleroi, Belgium, 6000 Az Maria MiddelaresGent, Belgium, 9000 Universitair Ziekenhuis GentGent, Belgium, 9000 Chc-Cliniques Saint-JosephLiÃ¨ge, Belgium, 4000 Sint-Augustinus AzWilrijk, Belgium, 2610 Chu Dinant Godinne Ucl NamurYvoir, Belgium, 5530|Barretos, Brazil, 14784-400 AssociaÃ§Ã£o MÃ¡rio Penna\\NÃºcleo De Ensino E PesquisasBelo Horizonte, Brazil, 30380-472 Hospital Erasto GaertnerCuritiba, Brazil, 81520-060 ClÃ­nica De Neoplasias Litoral Ltda.Itajai, Brazil, 88301-220 Upco - HcpaPorto Alegre, Brazil, 90035-903 Inca - Instituto Nacional Do CancerRio De Janeiro, Brazil, 20231-050 Fundacao Antonio PrudenteSao Paulo, Brazil, 01509900 Hospital De Base De SÃ£o JosÃ© Do Rio PretoSÃ£o JosÃ© Do Rio Preto, Brazil, 15090-000 Sociedade Beneficiante De Senhoras - Hospital Sirio LibanesSÃ£o Paulo, Brazil, 01308901 Cepho - Faculdade De Medicina Do AbcSÃ£o Paulo, Brazil, 09060-650|Kelowna, British Columbia, Canada, V1Y 5L3 Vancouver Cancer CentreVancouver, British Columbia, Canada, V5Z 4E6|Winnipeg, Manitoba, Canada, R3E 0V9|Thunder Bay, Ontario, Canada, P7B 6V4 Princess Margaret Hospital- UhnToronto, Ontario, Canada, M5G 2M9|Regina, Saskatchewan, Canada, S4T 7T1|Beijing, China, 100034 Beijing Friendship HospitalBeijing, China, 100050 Peking University Third HospitalBeijing, China, 100191 Beijing HospitalBeijing, China, 100730 Peking Union Medical College HospitalBeijing, China, 100730 Sichuan Provincial People'S HospitalChengdu, China, 610000 Sun Yat-Sen Memorial Hospital, Sun Yat-Sen UniversityGuangzhou, China, 510120 Guangzhou First Municipal People'S HospitalGuangzhou, China, 510180 Zhejiang Provincial People'S HospitalHangzhou, China, 310000 Sir Run Run Shaw Hospital, Zhejiang UniversityHangzhou, China, 310020 The First Affliated Hospital Of Nanchang UniversityNanchang, China, 330006 Nanjing Drum Tower HospitalNanjing, China, 210008 Jiangsu Cancer HospitalNanjing, China, 210009 Renji Hospital, Shanghai Jiaotong University School Of MedicineShanghai, China, 200127 Huadong Hospital Affiliated To Fudan UniversityShanghai, China, 200400 First Affiliated Hospital, Xi'An Jiaotong UniversityXi'An, China, 710061|Angers, France, 49055 Hopital Jean MinjozBesancon Cedex, France, 25030 Institut BergoniÃ©Bordeaux, France, 33000 Centre Jean PerrinClermont Ferrand, France, 63011 Centre Georges-FranÃ§ois LeclercDijon, France, 21079 Centre Oscar LambretLille, France, 59020 Centre Leon BÃ©rardLyon, France, 69008 Hopital De La TimoneMarseille, France, 13005 Institut Regional Du Cancer De Montpellier Val D'AurelleMontpellier, France, 34298 Centre Antoine LacassagneNice, France, 06189 Institut De CancÃ©rologie Du GardNÃ®mes, France, 30029 Hospital Saint-LouisParis Cedex 10, France, 75475 Hopital Europeen Georges-PompidouParis, France, 75015 Hospices Civils De Lyon HclPierre-BÃ©nite, France, 69495 Chu De PoitiersPoitiers Cedex, France, 86021 Centre Hopitalier Inter-Communal De CornouailleQuimper, France, 2900 Centre Eugene MarquisRennes Cedex, France, 35062 I.C.O. RenÃ© GauducheauSaint Herblain Cedex, France, 44805 Institut De CancÃ©rologie De LoireSaint-Priest-En-Jarez, France, 42271 Hopitaux Universitaires De StrasbourgStrasbourg, France, 67091 Institut Claudius RegaudToulouse, France, 31059 Institut Gustave RoussyVillejuif, France, 94805|Berlin, Germany, 10967 Universitatsklinikum Carl Gustav Carcus DresdenDresden, Germany, 01307 Universitaetsk"}},"Alaska|Arizona|California|Colorado|Florida|Georgia|Idaho|Illinois|Kentucky|Michigan|Nebraska|Nevada|New York|North Carolina|Pennsylvania|South Carolina|Texas|Virginia|Washington","Australia|Austria|Belgium|Brazil|Canada|China|France|Germany|Greece|Hungary|India|Israel|Italy|Japan|Mexico|Netherlands|Portugal|Spain|Turkey|Ukraine|United Kingdom|United States","Chris O'Brien Lifehouse|Lkh-Univ. Klinikum Graz|Olv Ziekenhuis Aalst|Fundacao Pio Xii - Hospital De Cancer De Barretos|British Columbia Bc Cancer Agency - Southern Interior|Manitoba Cancercare Manitoba|Ontario Thunder Bay Regional Health Sciences Centre|Saskatchewan Saskatchewan Cancer Agency (Sca) - Allan Blair Cancer Centre|Peking University First Hospital|Institut De CancÃ©rologie De L'Ouest (Ico)|Vivantes Klinikum Am Urban|University General Hospital Of Rio Patras|Semmelweis Egyetem|Manipal Comprehensive Cancer Centre, Manipal Hospital|Rambam Health Care Campus|Azienda Ospedaliera Nazionale Ss. Antonio E Biagio E Cesare Arrigo Alessandria|Chiba Cancer Center|San Peregrino Cancer Center|St. Antonius Ziekenhuis Nieuwegein|Hospital LusÃ­adas|Hosp. Univ. Infanta Cristina|Adana Baskent Practice And Research Hospital|Chernivtsi Regional Clinical Hospital|University Hospitals Bristol - Bristol Haematology & Oncolog|Alaska Urological Institute Dba Alaska Clinical Research Center|University Of Ua Cancer Center(Uacc)/Dh-Sjhmc|University Of California Irvine Medical Center - Chao Family Comprehensive Cancer Center|Uchealth Anschutz Cancer Pavilion|University Of Miami/Sylvester Cancer Center|Piedmont Cancer Institute|St. Luke's Meridian Medical Center|Northwestern University|Norton Cancer Institute|University Of Michigan Health System|University Of Nebraska Medical Center|Va Medical Center|Montefiore Medical Center|Levine Cancer Institute, Carolinas Healthcare System|Penn State Hershey Cancer Institute|University Of Missouri|The Center For Cancer And Blood Disorders|Inova Dwiight &Martha Schar Cancer Institute|Seattle Cancer Care Alliance",{"$nulls":3},"Janssen Research & Development, LLC Clinical Trials","2018-11-14","2020-05-25T16:35:12.401","2020-05-26T17:10:42.972","NCT03390504"]
["5ecbf3c011702c1b1b9169b1","NCT03390504","2018-12-14","Johnson & Johnson","JNJ","Recruiting","A Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Participants With Advanced Urothelial Cancer and Selected Fibroblast Growth Factor Receptor (FGFR) Gene Aberrations","Erdafitinib|Fibroblast|Vinflunine|Docetaxel|Pembrolizumab","FGFR Antagonist|Tubulin Inhibitor|Mitosis Inhibitor|Tubulin Inhibitor|PD-1 Inhibitor","Yes","['Erdafitinib', 'Fibroblast', 'Vinflunine']","No",null,"Phase 3",4,631,"Anticipated","2018-03-23","2020-11-24","OS","Overall Survival",{"$nulls":3},"The purpose of this study is to evaluate efficacy of erdafitinib versus chemotherapy or pembrolizumab in participants with advanced urothelial cancer harboring selected fibroblast growth factor receptor (FGFR) aberrations who have progressed after one prior treatment.","A study of erdafitinib versus standard of care, consisting of chemotherapy (docetaxel or vinflunine) or PD1 agent pembrolizumab, in participants with advanced urothelial cancer and selected FGFR aberrations who have progressed on or after one prior line of systemic therapy. It will consist of screening, treatment phase (from randomization until disease progression, intolerable toxicity, withdrawal of consent or decision by investigator to discontinue treatment, post-treatment follow-up (from end-of-treatment to participants death, withdraws consent, lost to follow-up, or end of study, whichever comes first). Efficacy, pharmacokinetics, biomarkers, patient reported outcomes, medical resource utilization and safety will be assessed.","A Phase 3 Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Subjects With Advanced Urothelial Cancer and Selected FGFR Gene Aberrations","CR108401","Urothelial Cancer","Transitional Cell Carcinoma","Oncology Solid Tumor","Oncology","Experimental","Cohort 1 (Arm 1A): Erdafitinib|Cohort 1 (Arm 1B): Vinflunine or Docetaxel|Cohort 2 (Arm 2A): Erdafitinib|Cohort 2 (Arm 2B): Pembrolizumab","Participants will be screened based on Fibroblast Growth Factor Receptor inhibitor Clinical Trial Assay (FGFRi CTA) to determine molecular eligibility and participants who meet molecular eligibility criteria will be enrolled. Participants (treated with prior anti-anti-programmed cell death protein [PD][L]1 agent) will swallow erdafitinib tablets orally at a starting dose of 8 milligram (mg), once daily for 21 days in a 21-day cycle until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustment are based on phosphate level and observed toxicity (adverse events [AEs]).|Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be enrolled. Participants (treated with prior anti-PD[L]1 agent) will receive vinflunine 320 milligram per meter square (mg/m^2) as a 20-minute intravenous infusion once every 3 weeks or docetaxel 75 mg/m^2 as a 1 hour intravenous infusion every 3 weeks. Treatment with either agent (choice of investigator) will be administered until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustments are based on observed toxicities.|Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be enrolled. Participants (no prior treatment with anti-PD(L)1 agent) will swallow erdafitinib tablets orally at a starting dose of 8 mg, once daily for 21 days in a 21-day cycle until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustments are based on phosphate level and observed toxicity (AEs).|Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be enrolled. Participants (no prior treatment with anti-PD(L)1 agent) will receive pembrolizumab 200 mg as a 30-minute intravenous infusion once every 3 weeks, until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustments are based on observed toxicities.","Drug|Device","Erdafitinib|Fibroblast Growth Factor Receptor inhibitor Clinical Trial Assay (FGFRi CTA)|Vinflunine|Docetaxel|Pembrolizumab","Participants will swallow erdafitinib tablets orally at a starting dose of 8 mg.|FGFRi CTA will be used to determine molecular eligibility.|Participants will receive vinflunine 320 mg/m^2 as a 20-minute intravenous infusion.|Participants will receive docetaxel 75 mg/m^2 as a 1 hour intravenous infusion.|Participants will receive pembrolizumab 200 mg as a 30-minute intravenous infusion.","JNJ-42756493","Cohort 1 (Arm 1A): Erdafitinib|Cohort 1 (Arm 1B): Vinflunine or Docetaxel|Cohort 2 (Arm 2A): Erdafitinib|Cohort 2 (Arm 2B): Pembrolizumab","\n\n * Histologic demonstration of transitional cell carcinoma of the urothelium. Minor components ( less than [<] 50 percent [%] overall) of variant histology such as glandular or squamous differentiation, or evolution to more aggressive phenotypes such as sarcomatoid or micropapillary change are acceptable\n * Metastatic or surgically unresectable urothelial cancer\n * Documented progression of disease, defined as any progression that requires a change in treatment, prior to randomization\n * Only one line of prior systemic treatment for metastatic urothelial cancer. Participants who received neoadjuvant or adjuvant chemotherapy and showed disease progression (as defined above), within 12 months of the last dose are considered to have received systemic chemotherapy in the metastatic setting Cohort 1: prior chemotherapy and anti-PD(L)1 [in combination or in maintenance setting] (anti-PD(L)1 alone is allowed only for participants with documented cisplatin ineligibility) and Cohort 2: prior chemotherapy (no prior anti-PD(L)1 treatment)\n * A woman of childbearing potential who is sexually active must have a negative pregnancy test (beta human chorionic gonadotropin [beta hCG]) at Screening (urine or serum)\n * Participants must meet appropriate molecular eligibility criteria\n * Eastern Cooperative Oncology Group (ECOG) performance status Grade 0, 1, or 2\n * Adequate bone marrow, liver, and renal function\n\n","\n\n * Treatment with any other investigational agent or participation in another clinical study with therapeutic intent within 30 days prior to randomization\n * Active malignancies (that is, requiring treatment change in the last 24 months). The only allowed exceptions are: urothelial cancer, skin cancer treated within the last 24 months that is considered completely cured, localized prostate cancer with a gleason score of 6 (treated within the last 24 months or untreated and under surveillance) and localized prostate cancer with a gleason score of 3+4 that has been treated more than 12 months prior to full study screening and considered completely cured\n * Symptomatic central nervous system metastases\n * Received prior fibroblast growth factor receptor (FGFR) inhibitor treatment\n * Known allergies, hypersensitivity, or intolerance to erdafitinib or its excipients\n * Corneal or retinal abnormality likely to increase the risk of eye toxicity or lens conditions, such as untreated mature or hypermature senile cataract, affecting visual acuity that impair the ability to interpret the Amsler grid test\n * History of uncontrolled cardiovascular disease\n * Impaired wound healing capacity defined as skin/decubitus ulcers, chronic leg ulcers, known gastric ulcers, or unhealed incisions",{"$nulls":4},"Actual","2018-01-04","Actual","Anticipated","2021-02-01","Anticipated","2018-12-01","2017-12-20","2018-01-03","2018-12-13","Yes",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No",null,null,"URL: http://pam.sylogent.com/cr/CR108401 [http://pam.sylogent.com/cr/CR108401] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To learn how to participate in this trial please click here.",null,"Yes","Yes",{"$nulls":17},"2017-002932-18|42756493BLC3001","EudraCT Number|Janssen Research & Development, LLC","Overall Survival (OS)","Overall survival is measured from the date of randomization to the date of the participant's death. If the participant is alive or the vital status is unknown, the participant will be censored at the date the participant was last known to be alive.","Date of first randomization to the date of participant's death (approximately up to 3 years)","Progression-free Survival (PFS)|Overall Response Rate (ORR)|Time to Worsening in Symptom Items and Functioning Subscales in Patient-Reported Health Status of the Functional Assessment of Cancer Therapy-Bladder Cancer (FACT-Bl)|Change from Baseline in Patient-Global Impression of Severity (PGIS) Score|Change from Baseline in the Visual Analog Scale (VAS) of the EQ-5D-5L|Change from Baseline in the Utility Scale of the EQ-5D-5L|Duration of Response (DOR)|Number of Participants with Adverse Events (AEs) as a Measure of Safety|Oral Clearance (CL/F) of Erdafitinib|Area Under the Plasma Concentration-Time Curve from Time Zero to Time 't' (AUC[0-t]) of Erdafitinib","PFS is defined as duration in days from date of randomization to disease progression date (assessed per Response Evaluation Criteria in Solid Tumors Version 1.1|ORR is defined as the proportion of participants who achieve CR (CR; disappearance of all target lesions and disappearance of all non-target lesions and normalization of tumor marker level) or partial response (PR; at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters), as assessed per RECIST v1.1 by the investigator.|The FACT-Bl consists of 36 core items, with 5-point Likert response scales, covering 5 primary domains: Physical well-being, social/family well-being, emotional well-being, functional well-being and bladder symptom subscale. The answer scales range from \"Not at all (score=0)\" to \"very much (score=4)\" to assess the meaningful significant symptom deterioration.|The PGIS is a single question regarding the participant report of disease severity. Participants will be asked that ''considering all aspects of your bladder cancer symptoms right now, would you say your bladder cancer symptoms are none, mild, moderate, severe, or very severe?\" The PGIS is an anchor question that will be used to establish the magnitude of meaningful change in this study by assessing disease severity.|European Quality of Life 5 Dimensions (EQ-5D) visual analog scale (VAS) is a 20 centimeter (cm) vertical VAS with scores ranging from 0 (worst imaginable health) to 100 (perfect health). A higher score indicates an improvement in health in the Health Status Index.|The EuroQol-5 is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating \"full health\" and 0 representing dead.|DOR for responders is defined as duration in days from the date of initial documentation of a response to the date of first documented evidence of progressive disease (PD) or relapse for participants who experience CR (CR; disappearance of all target lesions and disappearance of all non-target lesions and normalization of tumor marker level) during the study or death.|An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.|CL/F is the oral clearance; that is clearance based on oral bioavailability of erdafitinib.|AUC(0-t) is the area under the plasma concentration-time curve from time zero to any time 't' of erdafitinib.","RECIST v1.1 by investigator) or relapse from CR or death, whichever is reported first. RECIST 1.1, progressive disease is defined as a 20 percent (%) increase in the sum of diameters of all target lesions and a minimum absolute increase of 5 millimeter (mm) in the sum. CR is defined as disappearance of all target lesions, non-target lesions and normalization of tumor marker level.|Approximately up to 3 years|Baseline up to end of treatment (approximately 3 years)|Baseline up to follow up phase (approximately 3 years)|From the date of initial documentation of a response to date of first documented evidence of progressive disease (or participants relapse who experience CR during the study) or death (approximately up to 3 years)|Day 14 (Cycle 1), Day 1 (Cycle 2) (each cycle is of 21 days)","JNJ.CT@sylogent.com","Study Contact","844-434-4210",{"$cut":{"chars":16918,"head":"Camperdown, Australia, 2050 Peninsula & South Eastern Haematology And Oncology GroupFrankston, Australia, 3199 Royal Hobart HospitalHobart, Australia, 7000 Peter Maccallum Cancer CentreMelbourne, Australia, 3000 Frankston HospitalMelbourne, Australia, 3199 Southside Cancer Care CentreMiranda, Australia, 2228 Sir Charles Gairdner HospitalNedlands, Australia, 6009|Graz, Austria, 8036 Krankenhaus Der Barmherzigen SchwesternLinz, Austria, 4010 Lkh - UniversitÃ¤tsklinikum Der Pmu SalzburgSalzburg, Austria, 5020 Medical University Vienna, MuvVienna, Austria, A-1090|Aalst, Belgium, 9300 Zna MiddelheimAntwerpen, Belgium, 2020 Cliniques Universitaires Saint-LucBrussel, Belgium, 1200 Clinique Notre Dame De GrÃ¢ceCharleroi, Belgium, 6000 Az Maria MiddelaresGent, Belgium, 9000 Universitair Ziekenhuis GentGent, Belgium, 9000 Chc-Cliniques Saint-JosephLiÃ¨ge, Belgium, 4000 Sint-Augustinus AzWilrijk, Belgium, 2610 Chu Dinant Godinne Ucl NamurYvoir, Belgium, 5530|Barretos, Brazil, 14784-400 AssociaÃ§Ã£o MÃ¡rio Penna\\NÃºcleo De Ensino E PesquisasBelo Horizonte, Brazil, 30380-472 Hospital Erasto GaertnerCuritiba, Brazil, 81520-060 ClÃ­nica De Neoplasias Litoral Ltda.Itajai, Brazil, 88301-220 Upco - HcpaPorto Alegre, Brazil, 90035-903 Inca - Instituto Nacional Do CancerRio De Janeiro, Brazil, 20231-050 Fundacao Antonio PrudenteSao Paulo, Brazil, 01509900 Hospital De Base De SÃ£o JosÃ© Do Rio PretoSÃ£o JosÃ© Do Rio Preto, Brazil, 15090-000 Sociedade Beneficiante De Senhoras - Hospital Sirio LibanesSÃ£o Paulo, Brazil, 01308901 Cepho - Faculdade De Medicina Do AbcSÃ£o Paulo, Brazil, 09060-650|Kelowna, British Columbia, Canada, V1Y 5L3 Vancouver Cancer CentreVancouver, British Columbia, Canada, V5Z 4E6|Winnipeg, Manitoba, Canada, R3E 0V9|Thunder Bay, Ontario, Canada, P7B 6V4 Princess Margaret Hospital- UhnToronto, Ontario, Canada, M5G 2M9|Regina, Saskatchewan, Canada, S4T 7T1|Beijing, China, 100034 Beijing Friendship HospitalBeijing, China, 100050 Peking University Third HospitalBeijing, China, 100191 Beijing HospitalBeijing, China, 100730 Peking Union Medical College HospitalBeijing, China, 100730 Sichuan Provincial People'S HospitalChengdu, China, 610000 Sun Yat-Sen Memorial Hospital, Sun Yat-Sen UniversityGuangzhou, China, 510120 Guangzhou First Municipal People'S HospitalGuangzhou, China, 510180 Zhejiang Provincial People'S HospitalHangzhou, China, 310000 Sir Run Run Shaw Hospital, Zhejiang UniversityHangzhou, China, 310020 The First Affliated Hospital Of Nanchang UniversityNanchang, China, 330006 Nanjing Drum Tower HospitalNanjing, China, 210008 Jiangsu Cancer HospitalNanjing, China, 210009 Renji Hospital, Shanghai Jiaotong University School Of MedicineShanghai, China, 200127 Huadong Hospital Affiliated To Fudan UniversityShanghai, China, 200400 First Affiliated Hospital, Xi'An Jiaotong UniversityXi'An, China, 710061|Angers, France, 49055 Hopital Jean MinjozBesancon Cedex, France, 25030 Institut BergoniÃ©Bordeaux, France, 33000 Centre Jean PerrinClermont Ferrand, France, 63011 Centre Georges-FranÃ§ois LeclercDijon, France, 21079 Centre Oscar LambretLille, France, 59020 Centre Leon BÃ©rardLyon, France, 69008 Hopital De La TimoneMarseille, France, 13005 Institut Regional Du Cancer De Montpellier Val D'AurelleMontpellier, France, 34298 Centre Antoine LacassagneNice, France, 06189 Institut De CancÃ©rologie Du GardNÃ®mes, France, 30029 Hospital Saint-LouisParis Cedex 10, France, 75475 Hopital Europeen Georges-PompidouParis, France, 75015 Hospices Civils De Lyon HclPierre-BÃ©nite, France, 69495 Chu De PoitiersPoitiers Cedex, France, 86021 Centre Hopitalier Inter-Communal De CornouailleQuimper, France, 2900 Centre Eugene MarquisRennes Cedex, France, 35062 I.C.O. RenÃ© GauducheauSaint Herblain Cedex, France, 44805 Institut De CancÃ©rologie De LoireSaint-Priest-En-Jarez, France, 42271 Hopitaux Universitaires De StrasbourgStrasbourg, France, 67091 Institut Claudius RegaudToulouse, France, 31059 Institut Gustave RoussyVillejuif, France, 94805|Berlin, Germany, 10967 Universitatsklinikum Carl Gustav Carcus DresdenDresden, Germany, 01307 Universitaetsk"}},"Alaska|Arizona|California|Colorado|Florida|Georgia|Idaho|Illinois|Kentucky|Michigan|Nebraska|Nevada|New York|North Carolina|Pennsylvania|South Carolina|Texas|Virginia|Washington","Australia|Austria|Belgium|Brazil|Canada|China|France|Germany|Greece|Hungary|India|Israel|Italy|Japan|Mexico|Netherlands|Portugal|Spain|Turkey|Ukraine|United Kingdom|United States","Chris O'Brien Lifehouse|Lkh-Univ. Klinikum Graz|Olv Ziekenhuis Aalst|Fundacao Pio Xii - Hospital De Cancer De Barretos|British Columbia Bc Cancer Agency - Southern Interior|Manitoba Cancercare Manitoba|Ontario Thunder Bay Regional Health Sciences Centre|Saskatchewan Saskatchewan Cancer Agency (Sca) - Allan Blair Cancer Centre|Peking University First Hospital|Institut De CancÃ©rologie De L'Ouest (Ico)|Vivantes Klinikum Am Urban|University General Hospital Of Rio Patras|Semmelweis Egyetem|Manipal Comprehensive Cancer Centre, Manipal Hospital|Rambam Health Care Campus|Azienda Ospedaliera Nazionale Ss. Antonio E Biagio E Cesare Arrigo Alessandria|Chiba Cancer Center|San Peregrino Cancer Center|St. Antonius Ziekenhuis Nieuwegein|Hospital LusÃ­adas|Hosp. Univ. Infanta Cristina|Adana Baskent Practice And Research Hospital|Chernivtsi Regional Clinical Hospital|University Hospitals Bristol - Bristol Haematology & Oncolog|Alaska Urological Institute Dba Alaska Clinical Research Center|University Of Ua Cancer Center(Uacc)/Dh-Sjhmc|University Of California Irvine Medical Center - Chao Family Comprehensive Cancer Center|Uchealth Anschutz Cancer Pavilion|University Of Miami/Sylvester Cancer Center|Piedmont Cancer Institute|St. Luke's Meridian Medical Center|Northwestern University|Norton Cancer Institute|University Of Michigan Health System|University Of Nebraska Medical Center|Va Medical Center|Montefiore Medical Center|Levine Cancer Institute, Carolinas Healthcare System|Penn State Hershey Cancer Institute|University Of Missouri|The Center For Cancer And Blood Disorders|Inova Dwiight &Martha Schar Cancer Institute|Seattle Cancer Care Alliance",{"$nulls":3},"Janssen Research & Development, LLC Clinical Trials","2018-12-13","2020-05-25T16:35:12.428","2020-05-26T17:10:42.972","NCT03390504"]
["5ecbf3c0feab101b155307ce","NCT03390504","2019-01-11","Johnson & Johnson","JNJ","Recruiting","A Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Participants With Advanced Urothelial Cancer and Selected Fibroblast Growth Factor Receptor (FGFR) Gene Aberrations","Erdafitinib|Fibroblast|Vinflunine|Docetaxel|Pembrolizumab","FGFR Antagonist|Tubulin Inhibitor|Mitosis Inhibitor|Tubulin Inhibitor|PD-1 Inhibitor","Yes","['Erdafitinib', 'Fibroblast', 'Vinflunine']","No",null,"Phase 3",4,631,"Anticipated","2018-03-23","2020-11-24","OS","Overall Survival",{"$nulls":3},"The purpose of this study is to evaluate efficacy of erdafitinib versus chemotherapy or pembrolizumab in participants with advanced urothelial cancer harboring selected fibroblast growth factor receptor (FGFR) aberrations who have progressed after one prior treatment.","A study of erdafitinib versus standard of care, consisting of chemotherapy (docetaxel or vinflunine) or PD1 agent pembrolizumab, in participants with advanced urothelial cancer and selected FGFR aberrations who have progressed on or after one prior line of systemic therapy. It will consist of screening, treatment phase (from randomization until disease progression, intolerable toxicity, withdrawal of consent or decision by investigator to discontinue treatment, post-treatment follow-up (from end-of-treatment to participants death, withdraws consent, lost to follow-up, or end of study, whichever comes first). Efficacy, pharmacokinetics, biomarkers, patient reported outcomes, medical resource utilization and safety will be assessed.","A Phase 3 Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Subjects With Advanced Urothelial Cancer and Selected FGFR Gene Aberrations","CR108401","Urothelial Cancer","Transitional Cell Carcinoma","Oncology Solid Tumor","Oncology","Experimental","Cohort 1 (Arm 1A): Erdafitinib|Cohort 1 (Arm 1B): Vinflunine or Docetaxel|Cohort 2 (Arm 2A): Erdafitinib|Cohort 2 (Arm 2B): Pembrolizumab","Participants will be screened based on Fibroblast Growth Factor Receptor inhibitor Clinical Trial Assay (FGFRi CTA) to determine molecular eligibility and participants who meet molecular eligibility criteria will be enrolled. Participants (treated with prior anti-anti-programmed cell death protein [PD][L]1 agent) will swallow erdafitinib tablets orally at a starting dose of 8 milligram (mg), once daily for 21 days in a 21-day cycle until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustment are based on phosphate level and observed toxicity (adverse events [AEs]).|Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be enrolled. Participants (treated with prior anti-PD[L]1 agent) will receive vinflunine 320 milligram per meter square (mg/m^2) as a 20-minute intravenous infusion once every 3 weeks or docetaxel 75 mg/m^2 as a 1 hour intravenous infusion every 3 weeks. Treatment with either agent (choice of investigator) will be administered until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustments are based on observed toxicities.|Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be enrolled. Participants (no prior treatment with anti-PD(L)1 agent) will swallow erdafitinib tablets orally at a starting dose of 8 mg, once daily for 21 days in a 21-day cycle until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustments are based on phosphate level and observed toxicity (AEs).|Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be enrolled. Participants (no prior treatment with anti-PD(L)1 agent) will receive pembrolizumab 200 mg as a 30-minute intravenous infusion once every 3 weeks, until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustments are based on observed toxicities.","Drug|Device","Erdafitinib|Fibroblast Growth Factor Receptor inhibitor Clinical Trial Assay (FGFRi CTA)|Vinflunine|Docetaxel|Pembrolizumab","Participants will swallow erdafitinib tablets orally at a starting dose of 8 mg.|FGFRi CTA will be used to determine molecular eligibility.|Participants will receive vinflunine 320 mg/m^2 as a 20-minute intravenous infusion.|Participants will receive docetaxel 75 mg/m^2 as a 1 hour intravenous infusion.|Participants will receive pembrolizumab 200 mg as a 30-minute intravenous infusion.","JNJ-42756493","Cohort 1 (Arm 1A): Erdafitinib|Cohort 1 (Arm 1B): Vinflunine or Docetaxel|Cohort 2 (Arm 2A): Erdafitinib|Cohort 2 (Arm 2B): Pembrolizumab","\n\n * Histologic demonstration of transitional cell carcinoma of the urothelium. Minor components ( less than [<] 50 percent [%] overall) of variant histology such as glandular or squamous differentiation, or evolution to more aggressive phenotypes such as sarcomatoid or micropapillary change are acceptable\n * Metastatic or surgically unresectable urothelial cancer\n * Documented progression of disease, defined as any progression that requires a change in treatment, prior to randomization\n * Only one line of prior systemic treatment for metastatic urothelial cancer. Participants who received neoadjuvant or adjuvant chemotherapy and showed disease progression (as defined above), within 12 months of the last dose are considered to have received systemic chemotherapy in the metastatic setting Cohort 1: prior chemotherapy and anti-PD(L)1 [in combination or in maintenance setting] (anti-PD(L)1 alone is allowed only for participants with documented cisplatin ineligibility) and Cohort 2: prior chemotherapy (no prior anti-PD(L)1 treatment)\n * A woman of childbearing potential who is sexually active must have a negative pregnancy test (beta human chorionic gonadotropin [beta hCG]) at Screening (urine or serum)\n * Participants must meet appropriate molecular eligibility criteria\n * Eastern Cooperative Oncology Group (ECOG) performance status Grade 0, 1, or 2\n * Adequate bone marrow, liver, and renal function\n\n","\n\n * Treatment with any other investigational agent or participation in another clinical study with therapeutic intent within 30 days prior to randomization\n * Active malignancies (that is, requiring treatment change in the last 24 months). The only allowed exceptions are: urothelial cancer, skin cancer treated within the last 24 months that is considered completely cured, localized prostate cancer with a gleason score of 6 (treated within the last 24 months or untreated and under surveillance) and localized prostate cancer with a gleason score of 3+4 that has been treated more than 12 months prior to full study screening and considered completely cured\n * Symptomatic central nervous system metastases\n * Received prior fibroblast growth factor receptor (FGFR) inhibitor treatment\n * Known allergies, hypersensitivity, or intolerance to erdafitinib or its excipients\n * Corneal or retinal abnormality likely to increase the risk of eye toxicity or lens conditions, such as untreated mature or hypermature senile cataract, affecting visual acuity that impair the ability to interpret the Amsler grid test\n * History of uncontrolled cardiovascular disease\n * Impaired wound healing capacity defined as skin/decubitus ulcers, chronic leg ulcers, known gastric ulcers, or unhealed incisions",{"$nulls":4},"Actual","2018-01-04","Actual","Anticipated","2021-02-01","Anticipated","2019-01-01","2017-12-20","2018-01-03","2019-01-10","Yes",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No",null,null,"URL: http://pam.sylogent.com/cr/CR108401 [http://pam.sylogent.com/cr/CR108401] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To learn how to participate in this trial please click here.",null,"Yes","Yes",{"$nulls":17},"2017-002932-18|42756493BLC3001","EudraCT Number|Janssen Research & Development, LLC","Overall Survival (OS)","Overall survival is measured from the date of randomization to the date of the participant's death. If the participant is alive or the vital status is unknown, the participant will be censored at the date the participant was last known to be alive.","Date of first randomization to the date of participant's death (approximately up to 3 years)","Progression-free Survival (PFS)|Overall Response Rate (ORR)|Time to Worsening in Symptom Items and Functioning Subscales in Patient-Reported Health Status of the Functional Assessment of Cancer Therapy-Bladder Cancer (FACT-Bl)|Change from Baseline in Patient-Global Impression of Severity (PGIS) Score|Change from Baseline in the Visual Analog Scale (VAS) of the EQ-5D-5L|Change from Baseline in the Utility Scale of the EQ-5D-5L|Duration of Response (DOR)|Number of Participants with Adverse Events (AEs) as a Measure of Safety|Oral Clearance (CL/F) of Erdafitinib|Area Under the Plasma Concentration-Time Curve from Time Zero to Time 't' (AUC[0-t]) of Erdafitinib","PFS is defined as duration in days from date of randomization to disease progression date (assessed per Response Evaluation Criteria in Solid Tumors Version 1.1|ORR is defined as the proportion of participants who achieve CR (CR; disappearance of all target lesions and disappearance of all non-target lesions and normalization of tumor marker level) or partial response (PR; at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters), as assessed per RECIST v1.1 by the investigator.|The FACT-Bl consists of 36 core items, with 5-point Likert response scales, covering 5 primary domains: Physical well-being, social/family well-being, emotional well-being, functional well-being and bladder symptom subscale. The answer scales range from \"Not at all (score=0)\" to \"very much (score=4)\" to assess the meaningful significant symptom deterioration.|The PGIS is a single question regarding the participant report of disease severity. Participants will be asked that ''considering all aspects of your bladder cancer symptoms right now, would you say your bladder cancer symptoms are none, mild, moderate, severe, or very severe?\" The PGIS is an anchor question that will be used to establish the magnitude of meaningful change in this study by assessing disease severity.|European Quality of Life 5 Dimensions (EQ-5D) visual analog scale (VAS) is a 20 centimeter (cm) vertical VAS with scores ranging from 0 (worst imaginable health) to 100 (perfect health). A higher score indicates an improvement in health in the Health Status Index.|The EuroQol-5 is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating \"full health\" and 0 representing dead.|DOR for responders is defined as duration in days from the date of initial documentation of a response to the date of first documented evidence of progressive disease (PD) or relapse for participants who experience CR (CR; disappearance of all target lesions and disappearance of all non-target lesions and normalization of tumor marker level) during the study or death.|An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.|CL/F is the oral clearance; that is clearance based on oral bioavailability of erdafitinib.|AUC(0-t) is the area under the plasma concentration-time curve from time zero to any time 't' of erdafitinib.","RECIST v1.1 by investigator) or relapse from CR or death, whichever is reported first. RECIST 1.1, progressive disease is defined as a 20 percent (%) increase in the sum of diameters of all target lesions and a minimum absolute increase of 5 millimeter (mm) in the sum. CR is defined as disappearance of all target lesions, non-target lesions and normalization of tumor marker level.|Approximately up to 3 years|Baseline up to end of treatment (approximately 3 years)|Baseline up to follow up phase (approximately 3 years)|From the date of initial documentation of a response to date of first documented evidence of progressive disease (or participants relapse who experience CR during the study) or death (approximately up to 3 years)|Day 14 (Cycle 1), Day 1 (Cycle 2) (each cycle is of 21 days)","JNJ.CT@sylogent.com","Study Contact","844-434-4210",{"$cut":{"chars":16996,"head":"Camperdown, Australia, 2050 Peninsula & South Eastern Haematology And Oncology GroupFrankston, Australia, 3199 Royal Hobart HospitalHobart, Australia, 7000 Peter Maccallum Cancer CentreMelbourne, Australia, 3000 Frankston HospitalMelbourne, Australia, 3199 Southside Cancer Care CentreMiranda, Australia, 2228 Sir Charles Gairdner HospitalNedlands, Australia, 6009|Graz, Austria, 8036 Krankenhaus Der Barmherzigen SchwesternLinz, Austria, 4010 Lkh - UniversitÃ¤tsklinikum Der Pmu SalzburgSalzburg, Austria, 5020 Medical University Vienna, MuvVienna, Austria, A-1090|Aalst, Belgium, 9300 Zna MiddelheimAntwerpen, Belgium, 2020 Cliniques Universitaires Saint-LucBrussel, Belgium, 1200 Clinique Notre Dame De GrÃ¢ceCharleroi, Belgium, 6000 Az Maria MiddelaresGent, Belgium, 9000 Universitair Ziekenhuis GentGent, Belgium, 9000 Chc-Cliniques Saint-JosephLiÃ¨ge, Belgium, 4000 Sint-Augustinus AzWilrijk, Belgium, 2610 Chu Dinant Godinne Ucl NamurYvoir, Belgium, 5530|Barretos, Brazil, 14784-400 AssociaÃ§Ã£o MÃ¡rio Penna\\NÃºcleo De Ensino E PesquisasBelo Horizonte, Brazil, 30380-472 Hospital Erasto GaertnerCuritiba, Brazil, 81520-060 ClÃ­nica De Neoplasias Litoral Ltda.Itajai, Brazil, 88301-220 Upco - HcpaPorto Alegre, Brazil, 90035-903 Inca - Instituto Nacional Do CancerRio De Janeiro, Brazil, 20231-050 Fundacao Antonio PrudenteSao Paulo, Brazil, 01509900 Hospital De Base De SÃ£o JosÃ© Do Rio PretoSÃ£o JosÃ© Do Rio Preto, Brazil, 15090-000 Sociedade Beneficiante De Senhoras - Hospital Sirio LibanesSÃ£o Paulo, Brazil, 01308901 Cepho - Faculdade De Medicina Do AbcSÃ£o Paulo, Brazil, 09060-650|Kelowna, British Columbia, Canada, V1Y 5L3 Vancouver Cancer CentreVancouver, British Columbia, Canada, V5Z 4E6|Winnipeg, Manitoba, Canada, R3E 0V9|Thunder Bay, Ontario, Canada, P7B 6V4 Princess Margaret Hospital- UhnToronto, Ontario, Canada, M5G 2M9|Regina, Saskatchewan, Canada, S4T 7T1|Beijing, China, 100034 Beijing Friendship HospitalBeijing, China, 100050 Peking University Third HospitalBeijing, China, 100191 Beijing HospitalBeijing, China, 100730 Peking Union Medical College HospitalBeijing, China, 100730 Sichuan Provincial People'S HospitalChengdu, China, 610000 Sun Yat-Sen Memorial Hospital, Sun Yat-Sen UniversityGuangzhou, China, 510120 Guangzhou First Municipal People'S HospitalGuangzhou, China, 510180 Zhejiang Provincial People'S HospitalHangzhou, China, 310000 Sir Run Run Shaw Hospital, Zhejiang UniversityHangzhou, China, 310020 The First Affliated Hospital Of Nanchang UniversityNanchang, China, 330006 Nanjing Drum Tower HospitalNanjing, China, 210008 Jiangsu Cancer HospitalNanjing, China, 210009 Renji Hospital, Shanghai Jiaotong University School Of MedicineShanghai, China, 200127 Huadong Hospital Affiliated To Fudan UniversityShanghai, China, 200400 First Affiliated Hospital, Xi'An Jiaotong UniversityXi'An, China, 710061|Angers, France, 49055 Hopital Jean MinjozBesancon Cedex, France, 25030 Institut BergoniÃ©Bordeaux, France, 33000 Centre Jean PerrinClermont Ferrand, France, 63011 Centre Georges-FranÃ§ois LeclercDijon, France, 21079 Centre Oscar LambretLille, France, 59020 Centre Leon BÃ©rardLyon, France, 69008 Hopital De La TimoneMarseille, France, 13005 Institut Regional Du Cancer De Montpellier Val D'AurelleMontpellier, France, 34298 Centre Antoine LacassagneNice, France, 06189 Institut De CancÃ©rologie Du GardNÃ®mes, France, 30029 Hospital Saint-LouisParis Cedex 10, France, 75475 Hopital Europeen Georges-PompidouParis, France, 75015 Hospices Civils De Lyon HclPierre-BÃ©nite, France, 69495 Chu De PoitiersPoitiers Cedex, France, 86021 Centre Hopitalier Inter-Communal De CornouailleQuimper, France, 2900 Centre Eugene MarquisRennes Cedex, France, 35062 I.C.O. RenÃ© GauducheauSaint Herblain Cedex, France, 44805 Institut De CancÃ©rologie De LoireSaint-Priest-En-Jarez, France, 42271 Hopitaux Universitaires De StrasbourgStrasbourg, France, 67091 Institut Claudius RegaudToulouse, France, 31059 Institut Gustave RoussyVillejuif, France, 94805|Berlin, Germany, 10967 Universitatsklinikum Carl Gustav Carcus DresdenDresden, Germany, 01307 Universitaetsk"}},"Alaska|Arizona|California|Colorado|Florida|Georgia|Idaho|Illinois|Kentucky|Michigan|Nebraska|Nevada|New York|North Carolina|Pennsylvania|South Carolina|Texas|Virginia|Washington","Australia|Austria|Belgium|Brazil|Canada|China|France|Germany|Greece|Hungary|India|Israel|Italy|Japan|Mexico|Netherlands|Portugal|Spain|Turkey|Ukraine|United Kingdom|United States","Chris O'Brien Lifehouse|Lkh-Univ. Klinikum Graz|Olv Ziekenhuis Aalst|Fundacao Pio Xii - Hospital De Cancer De Barretos|British Columbia Bc Cancer Agency - Southern Interior|Manitoba Cancercare Manitoba|Ontario Thunder Bay Regional Health Sciences Centre|Saskatchewan Saskatchewan Cancer Agency (Sca) - Allan Blair Cancer Centre|Peking University First Hospital|Institut De CancÃ©rologie De L'Ouest (Ico)|Vivantes Klinikum Am Urban|University General Hospital Of Rio Patras|Semmelweis Egyetem|Manipal Comprehensive Cancer Centre, Manipal Hospital|Rambam Health Care Campus|Azienda Ospedaliera Nazionale Ss. Antonio E Biagio E Cesare Arrigo Alessandria|Chiba Cancer Center|San Peregrino Cancer Center|St. Antonius Ziekenhuis Nieuwegein|Hospital LusÃ­adas|Hosp. Univ. Infanta Cristina|Adana Baskent Practice And Research Hospital|Chernivtsi Regional Clinical Hospital|University Hospitals Bristol - Bristol Haematology & Oncolog|Alaska Urological Institute Dba Alaska Clinical Research Center|University Of Ua Cancer Center(Uacc)/Dh-Sjhmc|University Of California Irvine Medical Center - Chao Family Comprehensive Cancer Center|Uchealth Anschutz Cancer Pavilion|University Of Miami/Sylvester Cancer Center|Piedmont Cancer Institute|St. Luke's Meridian Medical Center|Northwestern University|Norton Cancer Institute|University Of Michigan Health System|University Of Nebraska Medical Center|Va Medical Center|Montefiore Medical Center|Levine Cancer Institute, Carolinas Healthcare System|Penn State Hershey Cancer Institute|University Of Missouri|The Center For Cancer And Blood Disorders|Inova Dwiight &Martha Schar Cancer Institute|Seattle Cancer Care Alliance",{"$nulls":3},"Janssen Research & Development, LLC Clinical Trials","2019-01-10","2020-05-25T16:35:12.918","2020-05-26T17:10:42.972","NCT03390504"]
["5ecbf3c0307e3d1b1f8d9c2e","NCT03390504","2019-02-19","Johnson & Johnson","JNJ","Recruiting","A Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Participants With Advanced Urothelial Cancer and Selected Fibroblast Growth Factor Receptor (FGFR) Gene Aberrations","Erdafitinib|Fibroblast|Vinflunine|Docetaxel|Pembrolizumab","FGFR Antagonist|Tubulin Inhibitor|Mitosis Inhibitor|Tubulin Inhibitor|PD-1 Inhibitor","Yes","['Erdafitinib', 'Fibroblast', 'Vinflunine']","No",null,"Phase 3",4,631,"Anticipated","2018-03-23","2020-11-24","OS","Overall Survival",{"$nulls":3},"The purpose of this study is to evaluate efficacy of erdafitinib versus chemotherapy or pembrolizumab in participants with advanced urothelial cancer harboring selected fibroblast growth factor receptor (FGFR) aberrations who have progressed after 1 or 2 prior treatments, at least 1 of which includes an anti-PD-(L) 1 agent (cohort 1) or 1 prior treatment not containing an anti-PD-(L) 1 agent (cohort 2).","A study of erdafitinib versus standard of care, consisting of chemotherapy (docetaxel or vinflunine) or anti-PD-(L) 1 agent pembrolizumab, in participants with advanced urothelial cancer and selected FGFR aberrations who have progressed on or after 1 or 2 prior treatments, at least 1 of which includes an anti-PD-(L) 1 agent (cohort 1) or 1 prior treatment not containing an anti-PD-(L) 1 agent (cohort 2). It will consist of screening, treatment phase (from randomization until disease progression, intolerable toxicity, withdrawal of consent or decision by investigator to discontinue treatment, post-treatment followup (from end-of-treatment to participants death, withdraws consent, lost to follow-up, or end of study, whichever comes first). Efficacy, pharmacokinetics, biomarkers, patient reported outcomes, medical resource utilization and safety will be assessed.","A Phase 3 Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Subjects With Advanced Urothelial Cancer and Selected FGFR Gene Aberrations","CR108401","Urothelial Cancer","Transitional Cell Carcinoma","Oncology Solid Tumor","Oncology","Experimental","Cohort 1 (Arm 1A): Erdafitinib|Cohort 1 (Arm 1B): Vinflunine or Docetaxel|Cohort 2 (Arm 2A): Erdafitinib|Cohort 2 (Arm 2B): Pembrolizumab","Participants will be screened based on Fibroblast Growth Factor Receptor inhibitor Clinical Trial Assay (FGFRi CTA) to determine molecular eligibility and participants who meet molecular eligibility criteria will be eligible for full study screening. Participants enrolled in the study (treated with prior anti-programmed cell death protein PD-[L] 1 agent) will swallow erdafitinib tablets orally at a starting dose of 8 milligram (mg), once daily for 21 days in a 21-day cycle until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustment are based on phosphate level and observed toxicity (adverse events [AEs]).|Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be eligible for full study screening. Participants enrolled in the study (treated with prior anti-PD-[L] 1 agent) will receive vinflunine 320 milligram per meter square (mg/m^2) as a 20-minute intravenous infusion once every 3 weeks or docetaxel 75 mg/m^2 as a 1 hour intravenous infusion every 3 weeks. Treatment with either agent (choice of investigator) will be administered until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustments are based on observed toxicities.|Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be eligible for full study screening. Participants enrolled in the study (no prior treatment with anti-PD-[L] 1 agent) will swallow erdafitinib tablets orally at a starting dose of 8 mg, once daily for 21 days in a 21-day cycle until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustments are based on phosphate level and observed toxicity (AEs).|Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be eligible for full study screening. Participants enrolled in the study (no prior treatment with anti-PD-[L] 1 agent) will receive pembrolizumab 200 mg as a 30-minute intravenous infusion once every 3 weeks, until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustments are based on observed toxicities.","Drug|Device","Erdafitinib|Fibroblast Growth Factor Receptor inhibitor Clinical Trial Assay (FGFRi CTA)|Vinflunine|Docetaxel|Pembrolizumab","Participants will swallow erdafitinib tablets orally at a starting dose of 8 mg.|FGFRi CTA will be used to determine molecular eligibility.|Participants will receive vinflunine 320 mg/m^2 as a 20-minute intravenous infusion.|Participants will receive docetaxel 75 mg/m^2 as a 1 hour intravenous infusion.|Participants will receive pembrolizumab 200 mg as a 30-minute intravenous infusion.","JNJ-42756493","Cohort 1 (Arm 1A): Erdafitinib|Cohort 1 (Arm 1B): Vinflunine or Docetaxel|Cohort 2 (Arm 2A): Erdafitinib|Cohort 2 (Arm 2B): Pembrolizumab","\n\n * Histologic demonstration of transitional cell carcinoma of the urothelium. Minor components ( less than [<] 50 percent [%] overall) of variant histology such as glandular or squamous differentiation, or evolution to more aggressive phenotypes such as sarcomatoid or micropapillary change are acceptable\n * Metastatic or surgically unresectable urothelial cancer\n * Documented progression of disease, defined as any progression that requires a change in treatment, prior to randomization\n * Cohort 1: Prior treatment with an anti-PD-(L) 1 agent as monotherapy or as combination therapy; no more than 2 prior lines of systemic treatment. Cohort 2: No prior treatment with an anti-PD-(L) 1 agent; only 1 line of prior systemic treatment. Subjects who received neoadjuvant or adjuvant chemotherapy and showed disease progression within 12 months of the last dose are considered to have received systemic therapy in the metastatic setting.\n * A woman of childbearing potential who is sexually active must have a negative pregnancy test (beta human chorionic gonadotropin [beta hCG]) at Screening (urine or serum)\n * Participants must meet appropriate molecular eligibility criteria\n * Eastern Cooperative Oncology Group (ECOG) performance status Grade 0, 1, or 2\n * Adequate bone marrow, liver, and renal function\n\n","\n\n * Treatment with any other investigational agent or participation in another clinical study with therapeutic intent within 30 days prior to randomization\n * Active malignancies (that is, requiring treatment change in the last 24 months). The only allowed exceptions are: urothelial cancer, skin cancer treated within the last 24 months that is considered completely cured, localized prostate cancer with a gleason score of 6 (treated within the last 24 months or untreated and under surveillance) and localized prostate cancer with a gleason score of 3+4 that has been treated more than 6 months prior to full study screening and considered to have a very low risk of recurrence.\n * Symptomatic central nervous system metastases\n * Received prior fibroblast growth factor receptor (FGFR) inhibitor treatment\n * Known allergies, hypersensitivity, or intolerance to erdafitinib or its excipients\n * Current central serous retinopathy (CSR) or retinal pigment epithelial detachment of any grade.\n * History of uncontrolled cardiovascular disease\n * Impaired wound healing capacity defined as skin/decubitus ulcers, chronic leg ulcers, known gastric ulcers, or unhealed incisions",{"$nulls":4},"Actual","2018-01-04","Actual","Anticipated","2021-02-01","Anticipated","2019-02-01","2017-12-20","2018-01-03","2019-02-15","Yes",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No",null,null,"URL: http://pam.sylogent.com/cr/CR108401 [http://pam.sylogent.com/cr/CR108401] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To learn how to participate in this trial please click here.",null,"Yes","Yes",{"$nulls":17},"2017-002932-18|42756493BLC3001","EudraCT Number|Janssen Research & Development, LLC","Overall Survival (OS)","Overall survival is measured from the date of randomization to the date of the participant's death. If the participant is alive or the vital status is unknown, the participant will be censored at the date the participant was last known to be alive.","Date of first randomization to the date of participant's death (approximately up to 3 years)","Progression-free Survival (PFS)|Overall Response Rate (ORR)|Time to Worsening in Symptom Items and Functioning Subscales in Patient-Reported Health Status of the Functional Assessment of Cancer Therapy-Bladder Cancer (FACT-Bl)|Change from Baseline in Patient-Global Impression of Severity (PGIS) Score|Change from Baseline in the Visual Analog Scale (VAS) of the EQ-5D-5L|Change from Baseline in the Utility Scale of the EQ-5D-5L|Duration of Response (DOR)|Number of Participants with Adverse Events (AEs) as a Measure of Safety|Oral Clearance (CL/F) of Erdafitinib|Area Under the Plasma Concentration-Time Curve from Time Zero to Time 't' (AUC[0-t]) of Erdafitinib","PFS is defined as duration in days from date of randomization to disease progression date (assessed per Response Evaluation Criteria in Solid Tumors Version 1.1|ORR is defined as the proportion of participants who achieve CR (CR; disappearance of all target lesions and disappearance of all non-target lesions and normalization of tumor marker level) or partial response (PR; at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters), as assessed per RECIST v1.1 by the investigator.|The FACT-Bl consists of 36 core items, with 5-point Likert response scales, covering 5 primary domains: Physical well-being, social/family well-being, emotional well-being, functional well-being and bladder symptom subscale. The answer scales range from \"Not at all (score=0)\" to \"very much (score=4)\" to assess the meaningful significant symptom deterioration.|The PGIS is a single question regarding the participant report of disease severity. Participants will be asked that ''considering all aspects of your bladder cancer symptoms right now, would you say your bladder cancer symptoms are none, mild, moderate, severe, or very severe?\" The PGIS is an anchor question that will be used to establish the magnitude of meaningful change in this study by assessing disease severity.|European Quality of Life 5 Dimensions (EQ-5D) visual analog scale (VAS) is a 20 centimeter (cm) vertical VAS with scores ranging from 0 (worst imaginable health) to 100 (perfect health). A higher score indicates an improvement in health in the Health Status Index.|The EuroQol-5 is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating \"full health\" and 0 representing dead.|DOR for responders is defined as duration in days from the date of initial documentation of a response to the date of first documented evidence of progressive disease (PD) or relapse for participants who experience CR (CR; disappearance of all target lesions and disappearance of all non-target lesions and normalization of tumor marker level) during the study or death.|An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.|CL/F is the oral clearance; that is clearance based on oral bioavailability of erdafitinib.|AUC(0-t) is the area under the plasma concentration-time curve from time zero to any time 't' of erdafitinib.","RECIST v1.1 by investigator) or relapse from CR or death, whichever is reported first. RECIST 1.1, progressive disease is defined as a 20 percent (%) increase in the sum of diameters of all target lesions and a minimum absolute increase of 5 millimeter (mm) in the sum. CR is defined as disappearance of all target lesions, non-target lesions and normalization of tumor marker level.|Approximately up to 3 years|Baseline up to end of treatment (approximately 3 years)|Baseline up to follow up phase (approximately 3 years)|From the date of initial documentation of a response to date of first documented evidence of progressive disease (or participants relapse who experience CR during the study) or death (approximately up to 3 years)|Day 14 (Cycle 1), Day 1 (Cycle 2) (each cycle is of 21 days)","JNJ.CT@sylogent.com","Study Contact","844-434-4210",{"$cut":{"chars":17075,"head":"Camperdown, Australia, 2050 Peninsula & South Eastern Haematology And Oncology GroupFrankston, Australia, 3199 Royal Hobart HospitalHobart, Australia, 7000 Peter Maccallum Cancer CentreMelbourne, Australia, 3000 Frankston HospitalMelbourne, Australia, 3199 Southside Cancer Care CentreMiranda, Australia, 2228 Sir Charles Gairdner HospitalNedlands, Australia, 6009|Graz, Austria, 8036 Krankenhaus Der Barmherzigen SchwesternLinz, Austria, 4010 Lkh - UniversitÃ¤tsklinikum Der Pmu SalzburgSalzburg, Austria, 5020 Medical University Vienna, MuvVienna, Austria, A-1090|Aalst, Belgium, 9300 Zna MiddelheimAntwerpen, Belgium, 2020 Cliniques Universitaires Saint-LucBrussel, Belgium, 1200 Clinique Notre Dame De GrÃ¢ceCharleroi, Belgium, 6000 Az Maria MiddelaresGent, Belgium, 9000 Universitair Ziekenhuis GentGent, Belgium, 9000 Chc-Cliniques Saint-JosephLiÃ¨ge, Belgium, 4000 Sint-Augustinus AzWilrijk, Belgium, 2610 Chu Dinant Godinne Ucl NamurYvoir, Belgium, 5530|Barretos, Brazil, 14784-400 AssociaÃ§Ã£o MÃ¡rio Penna\\NÃºcleo De Ensino E PesquisasBelo Horizonte, Brazil, 30380-472 Hospital Erasto GaertnerCuritiba, Brazil, 81520-060 ClÃ­nica De Neoplasias Litoral Ltda.Itajai, Brazil, 88301-220 Upco - HcpaPorto Alegre, Brazil, 90035-903 Inca - Instituto Nacional Do CancerRio De Janeiro, Brazil, 20231-050 Fundacao Antonio PrudenteSao Paulo, Brazil, 01509900 Hospital De Base De SÃ£o JosÃ© Do Rio PretoSÃ£o JosÃ© Do Rio Preto, Brazil, 15090-000 Sociedade Beneficiante De Senhoras - Hospital Sirio LibanesSÃ£o Paulo, Brazil, 01308901 Cepho - Faculdade De Medicina Do AbcSÃ£o Paulo, Brazil, 09060-650|Kelowna, British Columbia, Canada, V1Y 5L3 Vancouver Cancer CentreVancouver, British Columbia, Canada, V5Z 4E6|Winnipeg, Manitoba, Canada, R3E 0V9|Thunder Bay, Ontario, Canada, P7B 6V4 Princess Margaret Hospital- UhnToronto, Ontario, Canada, M5G 2M9|Regina, Saskatchewan, Canada, S4T 7T1|Beijing, China, 100034 Beijing Friendship HospitalBeijing, China, 100050 Peking University Third HospitalBeijing, China, 100191 Beijing HospitalBeijing, China, 100730 Peking Union Medical College HospitalBeijing, China, 100730 Sichuan Provincial People'S HospitalChengdu, China, 610000 Sun Yat-Sen Memorial Hospital, Sun Yat-Sen UniversityGuangzhou, China, 510120 Guangzhou First Municipal People'S HospitalGuangzhou, China, 510180 Zhejiang Provincial People'S HospitalHangzhou, China, 310000 Sir Run Run Shaw Hospital, Zhejiang UniversityHangzhou, China, 310020 The First Affliated Hospital Of Nanchang UniversityNanchang, China, 330006 Nanjing Drum Tower HospitalNanjing, China, 210008 Jiangsu Cancer HospitalNanjing, China, 210009 Renji Hospital, Shanghai Jiaotong University School Of MedicineShanghai, China, 200127 Huadong Hospital Affiliated To Fudan UniversityShanghai, China, 200400 First Affiliated Hospital, Xi'An Jiaotong UniversityXi'An, China, 710061|Angers, France, 49055 Hopital Jean MinjozBesancon Cedex, France, 25030 Institut BergoniÃ©Bordeaux, France, 33000 Centre Jean PerrinClermont Ferrand, France, 63011 Centre Georges-FranÃ§ois LeclercDijon, France, 21079 Centre Oscar LambretLille, France, 59020 Centre Leon BÃ©rardLyon, France, 69008 Hopital De La TimoneMarseille, France, 13005 Institut Regional Du Cancer De Montpellier Val D'AurelleMontpellier, France, 34298 Centre Antoine LacassagneNice, France, 06189 Institut De CancÃ©rologie Du GardNÃ®mes, France, 30029 Hospital Saint-LouisParis Cedex 10, France, 75475 Hopital Europeen Georges-PompidouParis, France, 75015 Hospices Civils De Lyon HclPierre-BÃ©nite, France, 69495 Chu De PoitiersPoitiers Cedex, France, 86021 Centre Hopitalier Inter-Communal De CornouailleQuimper, France, 2900 Centre Eugene MarquisRennes Cedex, France, 35062 I.C.O. RenÃ© GauducheauSaint Herblain Cedex, France, 44805 Institut De CancÃ©rologie De LoireSaint-Priest-En-Jarez, France, 42271 Hopitaux Universitaires De StrasbourgStrasbourg, France, 67091 Institut Claudius RegaudToulouse, France, 31059 Institut Gustave RoussyVillejuif, France, 94805|Berlin, Germany, 10967 Universitatsklinikum Carl Gustav Carcus DresdenDresden, Germany, 01307 Universitaetsk"}},"Alaska|Arizona|California|Colorado|Florida|Georgia|Idaho|Illinois|Kentucky|Michigan|Nebraska|Nevada|New York|North Carolina|Pennsylvania|South Carolina|Texas|Virginia|Washington","Australia|Austria|Belgium|Brazil|Canada|China|France|Germany|Greece|Hungary|India|Israel|Italy|Japan|Mexico|Netherlands|Portugal|Spain|Turkey|Ukraine|United Kingdom|United States","Chris O'Brien Lifehouse|Lkh-Univ. Klinikum Graz|Olv Ziekenhuis Aalst|Fundacao Pio Xii - Hospital De Cancer De Barretos|British Columbia Bc Cancer Agency - Southern Interior|Manitoba Cancercare Manitoba|Ontario Thunder Bay Regional Health Sciences Centre|Saskatchewan Saskatchewan Cancer Agency (Sca) - Allan Blair Cancer Centre|Peking University First Hospital|Institut De CancÃ©rologie De L'Ouest (Ico)|Vivantes Klinikum Am Urban|University General Hospital Of Rio Patras|Semmelweis Egyetem|Manipal Comprehensive Cancer Centre, Manipal Hospital|Rambam Health Care Campus|Azienda Ospedaliera Nazionale Ss. Antonio E Biagio E Cesare Arrigo Alessandria|Chiba Cancer Center|San Peregrino Cancer Center|St. Antonius Ziekenhuis Nieuwegein|Hospital LusÃ­adas|Hosp. Univ. Infanta Cristina|Adana Baskent Practice And Research Hospital|Chernivtsi Regional Clinical Hospital|University Hospitals Bristol - Bristol Haematology & Oncolog|Alaska Urological Institute Dba Alaska Clinical Research Center|University Of Ua Cancer Center(Uacc)/Dh-Sjhmc|University Of California Irvine Medical Center - Chao Family Comprehensive Cancer Center|Uchealth Anschutz Cancer Pavilion|University Of Miami/Sylvester Cancer Center|Piedmont Cancer Institute|St. Luke's Meridian Medical Center|Northwestern University|Norton Cancer Institute|University Of Michigan Health System|University Of Nebraska Medical Center|Va Medical Center|Montefiore Medical Center|Levine Cancer Institute, Carolinas Healthcare System|Penn State Hershey Cancer Institute|University Of Missouri|The Center For Cancer And Blood Disorders|Inova Dwiight &Martha Schar Cancer Institute|Seattle Cancer Care Alliance",{"$nulls":3},"Janssen Research & Development, LLC Clinical Trials","2019-02-15","2020-05-25T16:35:12.899","2020-05-26T17:10:42.972","NCT03390504"]
["5ecbf3c0fe30261b1a04819e","NCT03390504","2019-03-04","Johnson & Johnson","JNJ","Recruiting","A Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Participants With Advanced Urothelial Cancer and Selected Fibroblast Growth Factor Receptor (FGFR) Gene Aberrations","Erdafitinib|Fibroblast|Vinflunine|Docetaxel|Pembrolizumab","FGFR Antagonist|Tubulin Inhibitor|Mitosis Inhibitor|Tubulin Inhibitor|PD-1 Inhibitor","Yes","['Erdafitinib', 'Fibroblast', 'Vinflunine']","No",null,"Phase 3",4,631,"Anticipated","2018-03-23","2020-11-24","OS","Overall Survival",{"$nulls":3},"The purpose of this study is to evaluate efficacy of erdafitinib versus chemotherapy or pembrolizumab in participants with advanced urothelial cancer harboring selected fibroblast growth factor receptor (FGFR) aberrations who have progressed after 1 or 2 prior treatments, at least 1 of which includes an anti-PD-(L) 1 agent (cohort 1) or 1 prior treatment not containing an anti-PD-(L) 1 agent (cohort 2).","A study of erdafitinib versus standard of care, consisting of chemotherapy (docetaxel or vinflunine) or anti-PD-(L) 1 agent pembrolizumab, in participants with advanced urothelial cancer and selected FGFR aberrations who have progressed on or after 1 or 2 prior treatments, at least 1 of which includes an anti-PD-(L) 1 agent (cohort 1) or 1 prior treatment not containing an anti-PD-(L) 1 agent (cohort 2). It will consist of screening, treatment phase (from randomization until disease progression, intolerable toxicity, withdrawal of consent or decision by investigator to discontinue treatment, post-treatment followup (from end-of-treatment to participants death, withdraws consent, lost to follow-up, or end of study, whichever comes first). Efficacy, pharmacokinetics, biomarkers, patient reported outcomes, medical resource utilization and safety will be assessed.","A Phase 3 Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Subjects With Advanced Urothelial Cancer and Selected FGFR Gene Aberrations","CR108401","Urothelial Cancer","Transitional Cell Carcinoma","Oncology Solid Tumor","Oncology","Experimental","Cohort 1 (Arm 1A): Erdafitinib|Cohort 1 (Arm 1B): Vinflunine or Docetaxel|Cohort 2 (Arm 2A): Erdafitinib|Cohort 2 (Arm 2B): Pembrolizumab","Participants will be screened based on Fibroblast Growth Factor Receptor inhibitor Clinical Trial Assay (FGFRi CTA) to determine molecular eligibility and participants who meet molecular eligibility criteria will be eligible for full study screening. Participants enrolled in the study (treated with prior anti-programmed cell death protein PD-[L] 1 agent) will swallow erdafitinib tablets orally at a starting dose of 8 milligram (mg), once daily for 21 days in a 21-day cycle until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustment are based on phosphate level and observed toxicity (adverse events [AEs]).|Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be eligible for full study screening. Participants enrolled in the study (treated with prior anti-PD-[L] 1 agent) will receive vinflunine 320 milligram per meter square (mg/m^2) as a 20-minute intravenous infusion once every 3 weeks or docetaxel 75 mg/m^2 as a 1 hour intravenous infusion every 3 weeks. Treatment with either agent (choice of investigator) will be administered until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustments are based on observed toxicities.|Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be eligible for full study screening. Participants enrolled in the study (no prior treatment with anti-PD-[L] 1 agent) will swallow erdafitinib tablets orally at a starting dose of 8 mg, once daily for 21 days in a 21-day cycle until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustments are based on phosphate level and observed toxicity (AEs).|Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be eligible for full study screening. Participants enrolled in the study (no prior treatment with anti-PD-[L] 1 agent) will receive pembrolizumab 200 mg as a 30-minute intravenous infusion once every 3 weeks, until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustments are based on observed toxicities.","Drug|Device","Erdafitinib|Fibroblast Growth Factor Receptor inhibitor Clinical Trial Assay (FGFRi CTA)|Vinflunine|Docetaxel|Pembrolizumab","Participants will swallow erdafitinib tablets orally at a starting dose of 8 mg.|FGFRi CTA will be used to determine molecular eligibility.|Participants will receive vinflunine 320 mg/m^2 as a 20-minute intravenous infusion.|Participants will receive docetaxel 75 mg/m^2 as a 1 hour intravenous infusion.|Participants will receive pembrolizumab 200 mg as a 30-minute intravenous infusion.","JNJ-42756493","Cohort 1 (Arm 1A): Erdafitinib|Cohort 1 (Arm 1B): Vinflunine or Docetaxel|Cohort 2 (Arm 2A): Erdafitinib|Cohort 2 (Arm 2B): Pembrolizumab","\n\n * Histologic demonstration of transitional cell carcinoma of the urothelium. Minor components ( less than [<] 50 percent [%] overall) of variant histology such as glandular or squamous differentiation, or evolution to more aggressive phenotypes such as sarcomatoid or micropapillary change are acceptable\n * Metastatic or surgically unresectable urothelial cancer\n * Documented progression of disease, defined as any progression that requires a change in treatment, prior to randomization\n * Cohort 1: Prior treatment with an anti-PD-(L) 1 agent as monotherapy or as combination therapy; no more than 2 prior lines of systemic treatment. Cohort 2: No prior treatment with an anti-PD-(L) 1 agent; only 1 line of prior systemic treatment. Subjects who received neoadjuvant or adjuvant chemotherapy and showed disease progression within 12 months of the last dose are considered to have received systemic therapy in the metastatic setting.\n * A woman of childbearing potential who is sexually active must have a negative pregnancy test (beta human chorionic gonadotropin [beta hCG]) at Screening (urine or serum)\n * Participants must meet appropriate molecular eligibility criteria\n * Eastern Cooperative Oncology Group (ECOG) performance status Grade 0, 1, or 2\n * Adequate bone marrow, liver, and renal function\n\n","\n\n * Treatment with any other investigational agent or participation in another clinical study with therapeutic intent within 30 days prior to randomization\n * Active malignancies (that is, requiring treatment change in the last 24 months). The only allowed exceptions are: urothelial cancer, skin cancer treated within the last 24 months that is considered completely cured, localized prostate cancer with a gleason score of 6 (treated within the last 24 months or untreated and under surveillance) and localized prostate cancer with a gleason score of 3+4 that has been treated more than 6 months prior to full study screening and considered to have a very low risk of recurrence.\n * Symptomatic central nervous system metastases\n * Received prior fibroblast growth factor receptor (FGFR) inhibitor treatment\n * Known allergies, hypersensitivity, or intolerance to erdafitinib or its excipients\n * Current central serous retinopathy (CSR) or retinal pigment epithelial detachment of any grade.\n * History of uncontrolled cardiovascular disease\n * Impaired wound healing capacity defined as skin/decubitus ulcers, chronic leg ulcers, known gastric ulcers, or unhealed incisions",{"$nulls":4},"Actual","2018-01-04","Actual","Anticipated","2021-02-01","Anticipated","2019-02-01","2017-12-20","2018-01-03","2019-03-01","Yes",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No",null,null,"URL: http://pam.sylogent.com/cr/CR108401 [http://pam.sylogent.com/cr/CR108401] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To learn how to participate in this trial please click here.",null,"Yes","Yes",{"$nulls":17},"2017-002932-18|42756493BLC3001","EudraCT Number|Janssen Research & Development, LLC","Overall Survival (OS)","Overall survival is measured from the date of randomization to the date of the participant's death. If the participant is alive or the vital status is unknown, the participant will be censored at the date the participant was last known to be alive.","Date of first randomization to the date of participant's death (approximately up to 3 years)","Progression-free Survival (PFS)|Overall Response Rate (ORR)|Time to Worsening in Symptom Items and Functioning Subscales in Patient-Reported Health Status of the Functional Assessment of Cancer Therapy-Bladder Cancer (FACT-Bl)|Change from Baseline in Patient-Global Impression of Severity (PGIS) Score|Change from Baseline in the Visual Analog Scale (VAS) of the EQ-5D-5L|Change from Baseline in the Utility Scale of the EQ-5D-5L|Duration of Response (DOR)|Number of Participants with Adverse Events (AEs) as a Measure of Safety|Oral Clearance (CL/F) of Erdafitinib|Area Under the Plasma Concentration-Time Curve from Time Zero to Time 't' (AUC[0-t]) of Erdafitinib","PFS is defined as duration in days from date of randomization to disease progression date (assessed per Response Evaluation Criteria in Solid Tumors Version 1.1|ORR is defined as the proportion of participants who achieve CR (CR; disappearance of all target lesions and disappearance of all non-target lesions and normalization of tumor marker level) or partial response (PR; at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters), as assessed per RECIST v1.1 by the investigator.|The FACT-Bl consists of 36 core items, with 5-point Likert response scales, covering 5 primary domains: Physical well-being, social/family well-being, emotional well-being, functional well-being and bladder symptom subscale. The answer scales range from \"Not at all (score=0)\" to \"very much (score=4)\" to assess the meaningful significant symptom deterioration.|The PGIS is a single question regarding the participant report of disease severity. Participants will be asked that ''considering all aspects of your bladder cancer symptoms right now, would you say your bladder cancer symptoms are none, mild, moderate, severe, or very severe?\" The PGIS is an anchor question that will be used to establish the magnitude of meaningful change in this study by assessing disease severity.|European Quality of Life 5 Dimensions (EQ-5D) visual analog scale (VAS) is a 20 centimeter (cm) vertical VAS with scores ranging from 0 (worst imaginable health) to 100 (perfect health). A higher score indicates an improvement in health in the Health Status Index.|The EuroQol-5 is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating \"full health\" and 0 representing dead.|DOR for responders is defined as duration in days from the date of initial documentation of a response to the date of first documented evidence of progressive disease (PD) or relapse for participants who experience CR (CR; disappearance of all target lesions and disappearance of all non-target lesions and normalization of tumor marker level) during the study or death.|An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.|CL/F is the oral clearance; that is clearance based on oral bioavailability of erdafitinib.|AUC(0-t) is the area under the plasma concentration-time curve from time zero to any time 't' of erdafitinib.","RECIST v1.1 by investigator) or relapse from CR or death, whichever is reported first. RECIST 1.1, progressive disease is defined as a 20 percent (%) increase in the sum of diameters of all target lesions and a minimum absolute increase of 5 millimeter (mm) in the sum. CR is defined as disappearance of all target lesions, non-target lesions and normalization of tumor marker level.|Approximately up to 3 years|Baseline up to end of treatment (approximately 3 years)|Baseline up to follow up phase (approximately 3 years)|From the date of initial documentation of a response to date of first documented evidence of progressive disease (or participants relapse who experience CR during the study) or death (approximately up to 3 years)|Day 14 (Cycle 1), Day 1 (Cycle 2) (each cycle is of 21 days)","JNJ.CT@sylogent.com","Study Contact","844-434-4210",{"$cut":{"chars":17116,"head":"Camperdown, Australia, 2050 Peninsula & South Eastern Haematology And Oncology GroupFrankston, Australia, 3199 Royal Hobart HospitalHobart, Australia, 7000 Peter Maccallum Cancer CentreMelbourne, Australia, 3000 Frankston HospitalMelbourne, Australia, 3199 Southside Cancer Care CentreMiranda, Australia, 2228 Sir Charles Gairdner HospitalNedlands, Australia, 6009|Graz, Austria, 8036 Krankenhaus Der Barmherzigen SchwesternLinz, Austria, 4010 Lkh - UniversitÃ¤tsklinikum Der Pmu SalzburgSalzburg, Austria, 5020 Medical University Vienna, MuvVienna, Austria, A-1090|Aalst, Belgium, 9300 Zna MiddelheimAntwerpen, Belgium, 2020 Cliniques Universitaires Saint-LucBrussel, Belgium, 1200 Clinique Notre Dame De GrÃ¢ceCharleroi, Belgium, 6000 Az Maria MiddelaresGent, Belgium, 9000 Universitair Ziekenhuis GentGent, Belgium, 9000 Chc-Cliniques Saint-JosephLiÃ¨ge, Belgium, 4000 Sint-Augustinus AzWilrijk, Belgium, 2610 Chu Dinant Godinne Ucl NamurYvoir, Belgium, 5530|Barretos, Brazil, 14784-400 AssociaÃ§Ã£o MÃ¡rio Penna\\NÃºcleo De Ensino E PesquisasBelo Horizonte, Brazil, 30380-472 Hospital Erasto GaertnerCuritiba, Brazil, 81520-060 ClÃ­nica De Neoplasias Litoral Ltda.Itajai, Brazil, 88301-220 Upco - HcpaPorto Alegre, Brazil, 90035-903 Inca - Instituto Nacional Do CancerRio De Janeiro, Brazil, 20231-050 Fundacao Antonio PrudenteSao Paulo, Brazil, 01509900 Hospital De Base De SÃ£o JosÃ© Do Rio PretoSÃ£o JosÃ© Do Rio Preto, Brazil, 15090-000 Sociedade Beneficiante De Senhoras - Hospital Sirio LibanesSÃ£o Paulo, Brazil, 01308901 Cepho - Faculdade De Medicina Do AbcSÃ£o Paulo, Brazil, 09060-650|Kelowna, British Columbia, Canada, V1Y 5L3 Vancouver Cancer CentreVancouver, British Columbia, Canada, V5Z 4E6|Winnipeg, Manitoba, Canada, R3E 0V9|Thunder Bay, Ontario, Canada, P7B 6V4 Princess Margaret Hospital- UhnToronto, Ontario, Canada, M5G 2M9|Regina, Saskatchewan, Canada, S4T 7T1|Beijing, China, 100034 Beijing Friendship HospitalBeijing, China, 100050 Peking University Third HospitalBeijing, China, 100191 Beijing HospitalBeijing, China, 100730 Peking Union Medical College HospitalBeijing, China, 100730 Sichuan Provincial People'S HospitalChengdu, China, 610000 Chongqing Medical UniversityChongqing, China, 400030 Sun Yat-Sen University Cancer CenterGuangzhou, China, 510060 Sun Yat-Sen Memorial Hospital, Sun Yat-Sen UniversityGuangzhou, China, 510120 Guangzhou First Municipal People'S HospitalGuangzhou, China, 510180 Zhejiang Provincial People'S HospitalHangzhou, China, 310000 Sir Run Run Shaw Hospital, Zhejiang UniversityHangzhou, China, 310020 The First Affliated Hospital Of Nanchang UniversityNanchang, China, 330006 Nanjing Drum Tower HospitalNanjing, China, 210008 Jiangsu Cancer HospitalNanjing, China, 210009 Renji Hospital, Shanghai Jiaotong University School Of MedicineShanghai, China, 200127 Huadong Hospital Affiliated To Fudan UniversityShanghai, China, 200400 First Affiliated Hospital, Xi'An Jiaotong UniversityXi'An, China, 710061|Angers, France, 49055 Hopital Jean MinjozBesancon Cedex, France, 25030 Institut BergoniÃ©Bordeaux, France, 33000 Centre Jean PerrinClermont Ferrand, France, 63011 Centre Georges-FranÃ§ois LeclercDijon, France, 21079 Centre Oscar LambretLille, France, 59020 Centre Leon BÃ©rardLyon, France, 69008 Hopital De La TimoneMarseille, France, 13005 Institut Regional Du Cancer De Montpellier Val D'AurelleMontpellier, France, 34298 Centre Antoine LacassagneNice, France, 06189 Institut De CancÃ©rologie Du GardNÃ®mes, France, 30029 Hospital Saint-LouisParis Cedex 10, France, 75475 Hopital Europeen Georges-PompidouParis, France, 75015 Hospices Civils De Lyon HclPierre-BÃ©nite, France, 69495 Chu De PoitiersPoitiers Cedex, France, 86021 Centre Hopitalier Inter-Communal De CornouailleQuimper, France, 29000 Centre Eugene MarquisRennes Cedex, France, 35062 I.C.O. RenÃ© GauducheauSaint Herblain Cedex, France, 44805 Institut De CancÃ©rologie De LoireSaint-Priest-En-Jarez, France, 42271 Hopitaux Universitaires De StrasbourgStrasbourg, France, 67091 Institut Claudius RegaudToulouse, France, 31059 Institut Gustave RoussyVillejuif, France,"}},"Alaska|Arizona|California|Colorado|Florida|Georgia|Idaho|Illinois|Kentucky|Michigan|Nebraska|Nevada|New York|North Carolina|Pennsylvania|South Carolina|Texas|Virginia|Washington","Australia|Austria|Belgium|Brazil|Canada|China|France|Germany|Greece|Hungary|India|Israel|Italy|Japan|Mexico|Netherlands|Portugal|Spain|Turkey|Ukraine|United Kingdom|United States","Chris O'Brien Lifehouse|Lkh-Univ. Klinikum Graz|Olv Ziekenhuis Aalst|Fundacao Pio Xii - Hospital De Cancer De Barretos|British Columbia Bc Cancer Agency - Southern Interior|Manitoba Cancercare Manitoba|Ontario Thunder Bay Regional Health Sciences Centre|Saskatchewan Saskatchewan Cancer Agency (Sca) - Allan Blair Cancer Centre|Peking University First Hospital|Institut De CancÃ©rologie De L'Ouest (Ico)|Vivantes Klinikum Am Urban|University General Hospital Of Rio Patras|Semmelweis Egyetem|Manipal Comprehensive Cancer Centre, Manipal Hospital|Rambam Health Care Campus|Azienda Ospedaliera Nazionale Ss. Antonio E Biagio E Cesare Arrigo Alessandria|Chiba Cancer Center|San Peregrino Cancer Center|St. Antonius Ziekenhuis Nieuwegein|Hospital LusÃ­adas|Hosp. Univ. Infanta Cristina|Adana Baskent Practice And Research Hospital|Chernivtsi Regional Clinical Hospital|University Hospitals Bristol - Bristol Haematology & Oncolog|Alaska Urological Institute Dba Alaska Clinical Research Center|University Of Ua Cancer Center(Uacc)/Dh-Sjhmc|University Of California Irvine Medical Center - Chao Family Comprehensive Cancer Center|Uchealth Anschutz Cancer Pavilion|University Of Miami/Sylvester Cancer Center|Piedmont Cancer Institute|St. Luke's Meridian Medical Center|Northwestern University|Norton Cancer Institute|University Of Michigan Health System|University Of Nebraska Medical Center|Va Medical Center|Montefiore Medical Center|Levine Cancer Institute, Carolinas Healthcare System|Penn State Hershey Cancer Institute|University Of Missouri|The Center For Cancer And Blood Disorders|Inova Dwiight &Martha Schar Cancer Institute|Seattle Cancer Care Alliance",{"$nulls":3},"Janssen Research & Development, LLC Clinical Trials","2019-03-01","2020-05-25T16:35:12.899","2020-05-26T17:10:42.972","NCT03390504"]
["5ecbf3c111702c1b1b9169b2","NCT03390504","2019-04-04","Johnson & Johnson","JNJ","Recruiting","A Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Participants With Advanced Urothelial Cancer and Selected Fibroblast Growth Factor Receptor (FGFR) Gene Aberrations","Erdafitinib|Fibroblast|Vinflunine|Docetaxel|Pembrolizumab","FGFR Antagonist|Tubulin Inhibitor|Mitosis Inhibitor|Tubulin Inhibitor|PD-1 Inhibitor","Yes","['Erdafitinib', 'Fibroblast', 'Vinflunine']","No",null,"Phase 3",4,631,"Anticipated","2018-03-23","2020-11-24","OS","Overall Survival",{"$nulls":3},"The purpose of this study is to evaluate efficacy of erdafitinib versus chemotherapy or pembrolizumab in participants with advanced urothelial cancer harboring selected fibroblast growth factor receptor (FGFR) aberrations who have progressed after 1 or 2 prior treatments, at least 1 of which includes an anti-PD-(L) 1 agent (cohort 1) or 1 prior treatment not containing an anti-PD-(L) 1 agent (cohort 2).","A study of erdafitinib versus standard of care, consisting of chemotherapy (docetaxel or vinflunine) or anti-PD-(L) 1 agent pembrolizumab, in participants with advanced urothelial cancer and selected FGFR aberrations who have progressed on or after 1 or 2 prior treatments, at least 1 of which includes an anti-PD-(L) 1 agent (cohort 1) or 1 prior treatment not containing an anti-PD-(L) 1 agent (cohort 2). It will consist of screening, treatment phase (from randomization until disease progression, intolerable toxicity, withdrawal of consent or decision by investigator to discontinue treatment, post-treatment followup (from end-of-treatment to participants death, withdraws consent, lost to follow-up, or end of study, whichever comes first). Efficacy, pharmacokinetics, biomarkers, patient reported outcomes, medical resource utilization and safety will be assessed.","A Phase 3 Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Subjects With Advanced Urothelial Cancer and Selected FGFR Gene Aberrations","CR108401","Urothelial Cancer","Transitional Cell Carcinoma","Oncology Solid Tumor","Oncology","Experimental","Cohort 1 (Arm 1A): Erdafitinib|Cohort 1 (Arm 1B): Vinflunine or Docetaxel|Cohort 2 (Arm 2A): Erdafitinib|Cohort 2 (Arm 2B): Pembrolizumab","Participants will be screened based on Fibroblast Growth Factor Receptor inhibitor Clinical Trial Assay (FGFRi CTA) to determine molecular eligibility and participants who meet molecular eligibility criteria will be eligible for full study screening. Participants enrolled in the study (treated with prior anti-programmed cell death protein PD-[L] 1 agent) will swallow erdafitinib tablets orally at a starting dose of 8 milligram (mg), once daily for 21 days in a 21-day cycle until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustment are based on phosphate level and observed toxicity (adverse events [AEs]).|Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be eligible for full study screening. Participants enrolled in the study (treated with prior anti-PD-[L] 1 agent) will receive vinflunine 320 milligram per meter square (mg/m^2) as a 20-minute intravenous infusion once every 3 weeks or docetaxel 75 mg/m^2 as a 1 hour intravenous infusion every 3 weeks. Treatment with either agent (choice of investigator) will be administered until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustments are based on observed toxicities.|Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be eligible for full study screening. Participants enrolled in the study (no prior treatment with anti-PD-[L] 1 agent) will swallow erdafitinib tablets orally at a starting dose of 8 mg, once daily for 21 days in a 21-day cycle until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustments are based on phosphate level and observed toxicity (AEs).|Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be eligible for full study screening. Participants enrolled in the study (no prior treatment with anti-PD-[L] 1 agent) will receive pembrolizumab 200 mg as a 30-minute intravenous infusion once every 3 weeks, until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustments are based on observed toxicities.","Drug|Device","Erdafitinib|Fibroblast Growth Factor Receptor inhibitor Clinical Trial Assay (FGFRi CTA)|Vinflunine|Docetaxel|Pembrolizumab","Participants will swallow erdafitinib tablets orally at a starting dose of 8 mg.|FGFRi CTA will be used to determine molecular eligibility.|Participants will receive vinflunine 320 mg/m^2 as a 20-minute intravenous infusion.|Participants will receive docetaxel 75 mg/m^2 as a 1 hour intravenous infusion.|Participants will receive pembrolizumab 200 mg as a 30-minute intravenous infusion.","JNJ-42756493","Cohort 1 (Arm 1A): Erdafitinib|Cohort 1 (Arm 1B): Vinflunine or Docetaxel|Cohort 2 (Arm 2A): Erdafitinib|Cohort 2 (Arm 2B): Pembrolizumab","\n\n * Histologic demonstration of transitional cell carcinoma of the urothelium. Minor components ( less than [<] 50 percent [%] overall) of variant histology such as glandular or squamous differentiation, or evolution to more aggressive phenotypes such as sarcomatoid or micropapillary change are acceptable\n * Metastatic or surgically unresectable urothelial cancer\n * Documented progression of disease, defined as any progression that requires a change in treatment, prior to randomization\n * Cohort 1: Prior treatment with an anti-PD-(L) 1 agent as monotherapy or as combination therapy; no more than 2 prior lines of systemic treatment. Cohort 2: No prior treatment with an anti-PD-(L) 1 agent; only 1 line of prior systemic treatment. Subjects who received neoadjuvant or adjuvant chemotherapy and showed disease progression within 12 months of the last dose are considered to have received systemic therapy in the metastatic setting.\n * A woman of childbearing potential who is sexually active must have a negative pregnancy test (beta human chorionic gonadotropin [beta hCG]) at Screening (urine or serum)\n * Participants must meet appropriate molecular eligibility criteria\n * Eastern Cooperative Oncology Group (ECOG) performance status Grade 0, 1, or 2\n * Adequate bone marrow, liver, and renal function\n\n","\n\n * Treatment with any other investigational agent or participation in another clinical study with therapeutic intent within 30 days prior to randomization\n * Active malignancies (that is, requiring treatment change in the last 24 months). The only allowed exceptions are: urothelial cancer, skin cancer treated within the last 24 months that is considered completely cured, localized prostate cancer with a gleason score of 6 (treated within the last 24 months or untreated and under surveillance) and localized prostate cancer with a gleason score of 3+4 that has been treated more than 6 months prior to full study screening and considered to have a very low risk of recurrence.\n * Symptomatic central nervous system metastases\n * Received prior fibroblast growth factor receptor (FGFR) inhibitor treatment\n * Known allergies, hypersensitivity, or intolerance to erdafitinib or its excipients\n * Current central serous retinopathy (CSR) or retinal pigment epithelial detachment of any grade.\n * History of uncontrolled cardiovascular disease\n * Impaired wound healing capacity defined as skin/decubitus ulcers, chronic leg ulcers, known gastric ulcers, or unhealed incisions",{"$nulls":4},"Actual","2018-01-04","Actual","Anticipated","2021-11-05","Anticipated","2019-04-01","2017-12-20","2018-01-03","2019-04-03","Yes",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No",null,null,"URL: http://pam.sylogent.com/cr/CR108401 [http://pam.sylogent.com/cr/CR108401] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To learn how to participate in this trial please click here.",null,"Yes","Yes",{"$nulls":17},"2017-002932-18|42756493BLC3001","EudraCT Number|Janssen Research & Development, LLC","Overall Survival (OS)","Overall survival is measured from the date of randomization to the date of the participant's death. If the participant is alive or the vital status is unknown, the participant will be censored at the date the participant was last known to be alive.","Date of first randomization to the date of participant's death (approximately up to 3 years)","Progression-free Survival (PFS)|Overall Response Rate (ORR)|Time to Worsening in Symptom Items and Functioning Subscales in Patient-Reported Health Status of the Functional Assessment of Cancer Therapy-Bladder Cancer (FACT-Bl)|Change from Baseline in Patient-Global Impression of Severity (PGIS) Score|Change from Baseline in the Visual Analog Scale (VAS) of the EQ-5D-5L|Change from Baseline in the Utility Scale of the EQ-5D-5L|Duration of Response (DOR)|Number of Participants with Adverse Events (AEs) as a Measure of Safety|Oral Clearance (CL/F) of Erdafitinib|Area Under the Plasma Concentration-Time Curve from Time Zero to Time 't' (AUC[0-t]) of Erdafitinib","PFS is defined as duration in days from date of randomization to disease progression date (assessed per Response Evaluation Criteria in Solid Tumors Version 1.1|ORR is defined as the proportion of participants who achieve CR (CR; disappearance of all target lesions and disappearance of all non-target lesions and normalization of tumor marker level) or partial response (PR; at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters), as assessed per RECIST v1.1 by the investigator.|The FACT-Bl consists of 36 core items, with 5-point Likert response scales, covering 5 primary domains: Physical well-being, social/family well-being, emotional well-being, functional well-being and bladder symptom subscale. The answer scales range from \"Not at all (score=0)\" to \"very much (score=4)\" to assess the meaningful significant symptom deterioration.|The PGIS is a single question regarding the participant report of disease severity. Participants will be asked that ''considering all aspects of your bladder cancer symptoms right now, would you say your bladder cancer symptoms are none, mild, moderate, severe, or very severe?\" The PGIS is an anchor question that will be used to establish the magnitude of meaningful change in this study by assessing disease severity.|European Quality of Life 5 Dimensions (EQ-5D) visual analog scale (VAS) is a 20 centimeter (cm) vertical VAS with scores ranging from 0 (worst imaginable health) to 100 (perfect health). A higher score indicates an improvement in health in the Health Status Index.|The EuroQol-5 is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating \"full health\" and 0 representing dead.|DOR for responders is defined as duration in days from the date of initial documentation of a response to the date of first documented evidence of progressive disease (PD) or relapse for participants who experience CR (CR; disappearance of all target lesions and disappearance of all non-target lesions and normalization of tumor marker level) during the study or death.|An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.|CL/F is the oral clearance; that is clearance based on oral bioavailability of erdafitinib.|AUC(0-t) is the area under the plasma concentration-time curve from time zero to any time 't' of erdafitinib.","RECIST v1.1 by investigator) or relapse from CR or death, whichever is reported first. RECIST 1.1, progressive disease is defined as a 20 percent (%) increase in the sum of diameters of all target lesions and a minimum absolute increase of 5 millimeter (mm) in the sum. CR is defined as disappearance of all target lesions, non-target lesions and normalization of tumor marker level.|Approximately up to 3 years|Baseline up to end of treatment (approximately 3 years)|Baseline up to follow up phase (approximately 3 years)|From the date of initial documentation of a response to date of first documented evidence of progressive disease (or participants relapse who experience CR during the study) or death (approximately up to 3 years)|Day 14 (Cycle 1), Day 1 (Cycle 2) (each cycle is of 21 days)","JNJ.CT@sylogent.com","Study Contact","844-434-4210",{"$cut":{"chars":17118,"head":"Camperdown, Australia, 2050 Peninsula & South Eastern Haematology And Oncology GroupFrankston, Australia, 3199 Royal Hobart HospitalHobart, Australia, 7000 Peter Maccallum Cancer CentreMelbourne, Australia, 3000 Frankston HospitalMelbourne, Australia, 3199 Southside Cancer Care CentreMiranda, Australia, 2228 Sir Charles Gairdner HospitalNedlands, Australia, 6009|Graz, Austria, 8036 Krankenhaus Der Barmherzigen SchwesternLinz, Austria, 4010 Lkh - UniversitÃ¤tsklinikum Der Pmu SalzburgSalzburg, Austria, 5020 Medical University Vienna, MuvVienna, Austria, A-1090|Aalst, Belgium, 9300 Zna MiddelheimAntwerpen, Belgium, 2020 Cliniques Universitaires Saint-LucBrussel, Belgium, 1200 Clinique Notre Dame De GrÃ¢ceCharleroi, Belgium, 6000 Az Maria MiddelaresGent, Belgium, 9000 Universitair Ziekenhuis GentGent, Belgium, 9000 Chc-Cliniques Saint-JosephLiÃ¨ge, Belgium, 4000 Sint-Augustinus AzWilrijk, Belgium, 2610 Chu Dinant Godinne Ucl NamurYvoir, Belgium, 5530|Barretos, Brazil, 14784-400 AssociaÃ§Ã£o MÃ¡rio Penna\\NÃºcleo De Ensino E PesquisasBelo Horizonte, Brazil, 30380-472 Hospital Erasto GaertnerCuritiba, Brazil, 81520-060 ClÃ­nica De Neoplasias Litoral Ltda.Itajai, Brazil, 88301-220 Upco - HcpaPorto Alegre, Brazil, 90035-903 Inca - Instituto Nacional Do CancerRio De Janeiro, Brazil, 20231-050 Fundacao Antonio PrudenteSao Paulo, Brazil, 01509900 Hospital De Base De SÃ£o JosÃ© Do Rio PretoSÃ£o JosÃ© Do Rio Preto, Brazil, 15090-000 Sociedade Beneficiante De Senhoras - Hospital Sirio LibanesSÃ£o Paulo, Brazil, 01308901 Cepho - Faculdade De Medicina Do AbcSÃ£o Paulo, Brazil, 09060-650|Kelowna, British Columbia, Canada, V1Y 5L3 Vancouver Cancer CentreVancouver, British Columbia, Canada, V5Z 4E6|Winnipeg, Manitoba, Canada, R3E 0V9|Thunder Bay, Ontario, Canada, P7B 6V4 Princess Margaret Hospital- UhnToronto, Ontario, Canada, M5G 2M9|Regina, Saskatchewan, Canada, S4T 7T1|Beijing, China, 100034 Beijing Friendship HospitalBeijing, China, 100050 Peking University Third HospitalBeijing, China, 100191 Beijing HospitalBeijing, China, 100730 Peking Union Medical College HospitalBeijing, China, 100730 Sichuan Provincial People'S HospitalChengdu, China, 610000 Chongqing Medical UniversityChongqing, China, 400030 Sun Yat-Sen University Cancer CenterGuangzhou, China, 510060 Sun Yat-Sen Memorial Hospital, Sun Yat-Sen UniversityGuangzhou, China, 510120 Guangzhou First Municipal People'S HospitalGuangzhou, China, 510180 Zhejiang Provincial People'S HospitalHangzhou, China, 310000 Sir Run Run Shaw Hospital, Zhejiang UniversityHangzhou, China, 310020 The First Affliated Hospital Of Nanchang UniversityNanchang, China, 330006 Nanjing Drum Tower HospitalNanjing, China, 210008 Jiangsu Cancer HospitalNanjing, China, 210009 Renji Hospital, Shanghai Jiaotong University School Of MedicineShanghai, China, 200127 Huadong Hospital Affiliated To Fudan UniversityShanghai, China, 200400 First Affiliated Hospital, Xi'An Jiaotong UniversityXi'An, China, 710061|Angers, France, 49055 Hopital Jean MinjozBesancon Cedex, France, 25030 Institut BergoniÃ©Bordeaux, France, 33000 Centre Jean PerrinClermont Ferrand, France, 63011 Centre Georges-FranÃ§ois LeclercDijon, France, 21079 Centre Oscar LambretLille, France, 59020 Centre Leon BÃ©rardLyon, France, 69008 Hopital De La TimoneMarseille, France, 13005 Institut Regional Du Cancer De Montpellier Val D'AurelleMontpellier, France, 34298 Centre Antoine LacassagneNice, France, 06189 Institut De CancÃ©rologie Du GardNÃ®mes, France, 30029 Hospital Saint-LouisParis Cedex 10, France, 75475 Hopital Europeen Georges-PompidouParis, France, 75015 Hospices Civils De Lyon HclPierre-BÃ©nite, France, 69495 Chu De PoitiersPoitiers Cedex, France, 86021 Centre Hopitalier Inter-Communal De CornouailleQuimper, France, 29000 Centre Eugene MarquisRennes Cedex, France, 35062 I.C.O. RenÃ© GauducheauSaint Herblain Cedex, France, 44805 Institut De CancÃ©rologie De LoireSaint-Priest-En-Jarez, France, 42271 Hopitaux Universitaires De StrasbourgStrasbourg, France, 67091 Institut Claudius RegaudToulouse, France, 31059 Institut Gustave RoussyVillejuif, France,"}},"Alaska|Arizona|California|Colorado|Florida|Georgia|Idaho|Illinois|Kentucky|Michigan|Nebraska|Nevada|New York|North Carolina|Pennsylvania|South Carolina|Texas|Virginia|Washington","Australia|Austria|Belgium|Brazil|Canada|China|France|Germany|Greece|Hungary|India|Israel|Italy|Japan|Mexico|Netherlands|Portugal|Spain|Turkey|Ukraine|United Kingdom|United States","Chris O'Brien Lifehouse|Lkh-Univ. Klinikum Graz|Olv Ziekenhuis Aalst|Fundacao Pio Xii - Hospital De Cancer De Barretos|British Columbia Bc Cancer Agency - Southern Interior|Manitoba Cancercare Manitoba|Ontario Thunder Bay Regional Health Sciences Centre|Saskatchewan Saskatchewan Cancer Agency (Sca) - Allan Blair Cancer Centre|Peking University First Hospital|Institut De CancÃ©rologie De L'Ouest (Ico)|Vivantes Klinikum Am Urban|University General Hospital Of Rio Patras|Semmelweis Egyetem|Manipal Comprehensive Cancer Centre, Manipal Hospital|Rambam Health Care Campus|Azienda Ospedaliera Nazionale Ss. Antonio E Biagio E Cesare Arrigo Alessandria|Chiba Cancer Center|San Peregrino Cancer Center|St. Antonius Ziekenhuis Nieuwegein|Hospital LusÃ­adas|Hosp. Univ. Infanta Cristina|Adana Baskent Practice And Research Hospital|Chernivtsi Regional Clinical Hospital|University Hospitals Bristol - Bristol Haematology & Oncolog|Alaska Urological Institute Dba Alaska Clinical Research Center|University Of Ua Cancer Center(Uacc)/Dh-Sjhmc|University Of California Irvine Medical Center - Chao Family Comprehensive Cancer Center|Uchealth Anschutz Cancer Pavilion|University Of Miami/Sylvester Cancer Center|Piedmont Cancer Institute|St. Luke's Meridian Medical Center|Northwestern University|Norton Cancer Institute|University Of Michigan Health System|University Of Nebraska Medical Center|Va Sierra Nevada Health Care System|Montefiore Medical Center|Levine Cancer Institute, Carolinas Healthcare System|Penn State Hershey Cancer Institute|University Of Missouri|The Center For Cancer And Blood Disorders|Inova Dwiight &Martha Schar Cancer Institute|Seattle Cancer Care Alliance",{"$nulls":3},"Janssen Research & Development, LLC Clinical Trials","2019-04-03","2020-05-25T16:35:13.347","2020-05-26T17:10:42.972","NCT03390504"]
["5ecbf3c1fe30261b1a04819f","NCT03390504","2019-05-01","Johnson & Johnson","JNJ","Recruiting","A Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Participants With Advanced Urothelial Cancer and Selected Fibroblast Growth Factor Receptor (FGFR) Gene Aberrations","Erdafitinib|Fibroblast|Vinflunine|Docetaxel|Pembrolizumab","FGFR Antagonist|Tubulin Inhibitor|Mitosis Inhibitor|Tubulin Inhibitor|PD-1 Inhibitor","Yes","['Fibroblast', 'Vinflunine']","No",null,"Phase 3",4,631,"Anticipated","2018-03-23","2020-11-24","OS","Overall Survival",{"$nulls":3},"The purpose of this study is to evaluate efficacy of erdafitinib versus chemotherapy or pembrolizumab in participants with advanced urothelial cancer harboring selected fibroblast growth factor receptor (FGFR) aberrations who have progressed after 1 or 2 prior treatments, at least 1 of which includes an anti-PD-(L) 1 agent (cohort 1) or 1 prior treatment not containing an anti-PD-(L) 1 agent (cohort 2).","A study of erdafitinib versus standard of care, consisting of chemotherapy (docetaxel or vinflunine) or anti-PD-(L) 1 agent pembrolizumab, in participants with advanced urothelial cancer and selected FGFR aberrations who have progressed on or after 1 or 2 prior treatments, at least 1 of which includes an anti-PD-(L) 1 agent (cohort 1) or 1 prior treatment not containing an anti-PD-(L) 1 agent (cohort 2). It will consist of screening, treatment phase (from randomization until disease progression, intolerable toxicity, withdrawal of consent or decision by investigator to discontinue treatment, post-treatment followup (from end-of-treatment to participants death, withdraws consent, lost to follow-up, or end of study, whichever comes first). Efficacy, pharmacokinetics, biomarkers, patient reported outcomes, medical resource utilization and safety will be assessed.","A Phase 3 Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Subjects With Advanced Urothelial Cancer and Selected FGFR Gene Aberrations","CR108401","Urothelial Cancer","Transitional Cell Carcinoma","Oncology Solid Tumor","Oncology","Experimental","Cohort 1 (Arm 1A): Erdafitinib|Cohort 1 (Arm 1B): Vinflunine or Docetaxel|Cohort 2 (Arm 2A): Erdafitinib|Cohort 2 (Arm 2B): Pembrolizumab","Participants will be screened based on Fibroblast Growth Factor Receptor inhibitor Clinical Trial Assay (FGFRi CTA) to determine molecular eligibility and participants who meet molecular eligibility criteria will be eligible for full study screening. Participants enrolled in the study (treated with prior anti-programmed cell death protein PD-[L] 1 agent) will swallow erdafitinib tablets orally at a starting dose of 8 milligram (mg), once daily for 21 days in a 21-day cycle until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustment are based on phosphate level and observed toxicity (adverse events [AEs]).|Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be eligible for full study screening. Participants enrolled in the study (treated with prior anti-PD-[L] 1 agent) will receive vinflunine 320 milligram per meter square (mg/m^2) as a 20-minute intravenous infusion once every 3 weeks or docetaxel 75 mg/m^2 as a 1 hour intravenous infusion every 3 weeks. Treatment with either agent (choice of investigator) will be administered until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustments are based on observed toxicities.|Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be eligible for full study screening. Participants enrolled in the study (no prior treatment with anti-PD-[L] 1 agent) will swallow erdafitinib tablets orally at a starting dose of 8 mg, once daily for 21 days in a 21-day cycle until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustments are based on phosphate level and observed toxicity (AEs).|Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be eligible for full study screening. Participants enrolled in the study (no prior treatment with anti-PD-[L] 1 agent) will receive pembrolizumab 200 mg as a 30-minute intravenous infusion once every 3 weeks, until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustments are based on observed toxicities.","Drug|Device","Erdafitinib|Fibroblast Growth Factor Receptor inhibitor Clinical Trial Assay (FGFRi CTA)|Vinflunine|Docetaxel|Pembrolizumab","Participants will swallow erdafitinib tablets orally at a starting dose of 8 mg.|FGFRi CTA will be used to determine molecular eligibility.|Participants will receive vinflunine 320 mg/m^2 as a 20-minute intravenous infusion.|Participants will receive docetaxel 75 mg/m^2 as a 1 hour intravenous infusion.|Participants will receive pembrolizumab 200 mg as a 30-minute intravenous infusion.","JNJ-42756493","Cohort 1 (Arm 1A): Erdafitinib|Cohort 1 (Arm 1B): Vinflunine or Docetaxel|Cohort 2 (Arm 2A): Erdafitinib|Cohort 2 (Arm 2B): Pembrolizumab","\n\n * Histologic demonstration of transitional cell carcinoma of the urothelium. Minor components ( less than [<] 50 percent [%] overall) of variant histology such as glandular or squamous differentiation, or evolution to more aggressive phenotypes such as sarcomatoid or micropapillary change are acceptable\n * Metastatic or surgically unresectable urothelial cancer\n * Documented progression of disease, defined as any progression that requires a change in treatment, prior to randomization\n * Cohort 1: Prior treatment with an anti-PD-(L) 1 agent as monotherapy or as combination therapy; no more than 2 prior lines of systemic treatment. Cohort 2: No prior treatment with an anti-PD-(L) 1 agent; only 1 line of prior systemic treatment. Subjects who received neoadjuvant or adjuvant chemotherapy and showed disease progression within 12 months of the last dose are considered to have received systemic therapy in the metastatic setting.\n * A woman of childbearing potential who is sexually active must have a negative pregnancy test (beta human chorionic gonadotropin [beta hCG]) at Screening (urine or serum)\n * Participants must meet appropriate molecular eligibility criteria\n * Eastern Cooperative Oncology Group (ECOG) performance status Grade 0, 1, or 2\n * Adequate bone marrow, liver, and renal function\n\n","\n\n * Treatment with any other investigational agent or participation in another clinical study with therapeutic intent within 30 days prior to randomization\n * Active malignancies (that is, requiring treatment change in the last 24 months). The only allowed exceptions are: urothelial cancer, skin cancer treated within the last 24 months that is considered completely cured, localized prostate cancer with a gleason score of 6 (treated within the last 24 months or untreated and under surveillance) and localized prostate cancer with a gleason score of 3+4 that has been treated more than 6 months prior to full study screening and considered to have a very low risk of recurrence.\n * Symptomatic central nervous system metastases\n * Received prior fibroblast growth factor receptor (FGFR) inhibitor treatment\n * Known allergies, hypersensitivity, or intolerance to erdafitinib or its excipients\n * Current central serous retinopathy (CSR) or retinal pigment epithelial detachment of any grade.\n * History of uncontrolled cardiovascular disease\n * Impaired wound healing capacity defined as skin/decubitus ulcers, chronic leg ulcers, known gastric ulcers, or unhealed incisions",{"$nulls":4},"Actual","2018-01-04","Actual","Anticipated","2021-11-05","Anticipated","2019-04-01","2017-12-20","2018-01-03","2019-04-29","Yes",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No",null,null,"URL: http://pam.sylogent.com/cr/CR108401 [http://pam.sylogent.com/cr/CR108401] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To learn how to participate in this trial please click here.",null,"Yes","Yes",{"$nulls":17},"2017-002932-18|42756493BLC3001","EudraCT Number|Janssen Research & Development, LLC","Overall Survival (OS)","Overall survival is measured from the date of randomization to the date of the participant's death. If the participant is alive or the vital status is unknown, the participant will be censored at the date the participant was last known to be alive.","Date of first randomization to the date of participant's death (approximately up to 3 years)","Progression-free Survival (PFS)|Overall Response Rate (ORR)|Time to Worsening in Symptom Items and Functioning Subscales in Patient-Reported Health Status of the Functional Assessment of Cancer Therapy-Bladder Cancer (FACT-Bl)|Change from Baseline in Patient-Global Impression of Severity (PGIS) Score|Change from Baseline in the Visual Analog Scale (VAS) of the EQ-5D-5L|Change from Baseline in the Utility Scale of the EQ-5D-5L|Duration of Response (DOR)|Number of Participants with Adverse Events (AEs) as a Measure of Safety|Oral Clearance (CL/F) of Erdafitinib|Area Under the Plasma Concentration-Time Curve from Time Zero to Time 't' (AUC[0-t]) of Erdafitinib","PFS is defined as duration in days from date of randomization to disease progression date (assessed per Response Evaluation Criteria in Solid Tumors Version 1.1|ORR is defined as the proportion of participants who achieve CR (CR; disappearance of all target lesions and disappearance of all non-target lesions and normalization of tumor marker level) or partial response (PR; at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters), as assessed per RECIST v1.1 by the investigator.|The FACT-Bl consists of 36 core items, with 5-point Likert response scales, covering 5 primary domains: Physical well-being, social/family well-being, emotional well-being, functional well-being and bladder symptom subscale. The answer scales range from \"Not at all (score=0)\" to \"very much (score=4)\" to assess the meaningful significant symptom deterioration.|The PGIS is a single question regarding the participant report of disease severity. Participants will be asked that ''considering all aspects of your bladder cancer symptoms right now, would you say your bladder cancer symptoms are none, mild, moderate, severe, or very severe?\" The PGIS is an anchor question that will be used to establish the magnitude of meaningful change in this study by assessing disease severity.|European Quality of Life 5 Dimensions (EQ-5D) visual analog scale (VAS) is a 20 centimeter (cm) vertical VAS with scores ranging from 0 (worst imaginable health) to 100 (perfect health). A higher score indicates an improvement in health in the Health Status Index.|The EuroQol-5 is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating \"full health\" and 0 representing dead.|DOR for responders is defined as duration in days from the date of initial documentation of a response to the date of first documented evidence of progressive disease (PD) or relapse for participants who experience CR (CR; disappearance of all target lesions and disappearance of all non-target lesions and normalization of tumor marker level) during the study or death.|An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.|CL/F is the oral clearance; that is clearance based on oral bioavailability of erdafitinib.|AUC(0-t) is the area under the plasma concentration-time curve from time zero to any time 't' of erdafitinib.","RECIST v1.1 by investigator) or relapse from CR or death, whichever is reported first. RECIST 1.1, progressive disease is defined as a 20 percent (%) increase in the sum of diameters of all target lesions and a minimum absolute increase of 5 millimeter (mm) in the sum. CR is defined as disappearance of all target lesions, non-target lesions and normalization of tumor marker level.|Approximately up to 3 years|Baseline up to end of treatment (approximately 3 years)|Baseline up to follow up phase (approximately 3 years)|From the date of initial documentation of a response to date of first documented evidence of progressive disease (or participants relapse who experience CR during the study) or death (approximately up to 3 years)|Day 14 (Cycle 1), Day 1 (Cycle 2) (each cycle is of 21 days)","JNJ.CT@sylogent.com","Study Contact","844-434-4210",{"$cut":{"chars":17189,"head":"Camperdown, Australia, 2050 Peninsula & South Eastern Haematology And Oncology GroupFrankston, Australia, 3199 Royal Hobart HospitalHobart, Australia, 7000 St. George Private Hospital, Oncology Day Care CentreKogarah, Australia, 2217 Peter Maccallum Cancer CentreMelbourne, Australia, 3000 Frankston HospitalMelbourne, Australia, 3199 Fiona Stanley HospitalMurdoch, Australia, 6150|Graz, Austria, 8036 Krankenhaus Der Barmherzigen SchwesternLinz, Austria, 4010 Lkh - UniversitÃ¤tsklinikum Der Pmu SalzburgSalzburg, Austria, 5020 Medical University Vienna, MuvVienna, Austria, A-1090|Aalst, Belgium, 9300 Zna MiddelheimAntwerpen, Belgium, 2020 Cliniques Universitaires Saint-LucBrussel, Belgium, 1200 Clinique Notre Dame De GrÃ¢ceCharleroi, Belgium, 6000 Az Maria MiddelaresGent, Belgium, 9000 Universitair Ziekenhuis GentGent, Belgium, 9000 Chc-Cliniques Saint-JosephLiÃ¨ge, Belgium, 4000 Sint-Augustinus AzWilrijk, Belgium, 2610 Chu Dinant Godinne Ucl NamurYvoir, Belgium, 5530|Barretos, Brazil, 14784-400 AssociaÃ§Ã£o MÃ¡rio Penna\\NÃºcleo De Ensino E PesquisasBelo Horizonte, Brazil, 30380-472 Hospital Erasto GaertnerCuritiba, Brazil, 81520-060 ClÃ­nica De Neoplasias Litoral Ltda.Itajai, Brazil, 88301-220 Upco - HcpaPorto Alegre, Brazil, 90035-903 Inca - Instituto Nacional Do CancerRio De Janeiro, Brazil, 20231-050 Fundacao Antonio PrudenteSao Paulo, Brazil, 01509900 Hospital De Base De SÃ£o JosÃ© Do Rio PretoSÃ£o JosÃ© Do Rio Preto, Brazil, 15090-000 Sociedade Beneficiante De Senhoras - Hospital Sirio LibanesSÃ£o Paulo, Brazil, 01308901 Cepho - Faculdade De Medicina Do AbcSÃ£o Paulo, Brazil, 09060-650|Kelowna, British Columbia, Canada, V1Y 5L3 Vancouver Cancer CentreVancouver, British Columbia, Canada, V5Z 4E6|Winnipeg, Manitoba, Canada, R3E 0V9|Thunder Bay, Ontario, Canada, P7B 6V4 Princess Margaret Hospital- UhnToronto, Ontario, Canada, M5G 2M9|Regina, Saskatchewan, Canada, S4T 7T1|Beijing, China, 100034 Beijing Friendship HospitalBeijing, China, 100050 Peking University Third HospitalBeijing, China, 100191 Beijing HospitalBeijing, China, 100730 Peking Union Medical College HospitalBeijing, China, 100730 Sichuan Provincial People'S HospitalChengdu, China, 610000 Chongqing Medical UniversityChongqing, China, 400030 Sun Yat-Sen University Cancer CenterGuangzhou, China, 510060 Sun Yat-Sen Memorial Hospital, Sun Yat-Sen UniversityGuangzhou, China, 510120 Guangzhou First Municipal People'S HospitalGuangzhou, China, 510180 Zhejiang Provincial People'S HospitalHangzhou, China, 310000 Sir Run Run Shaw Hospital, Zhejiang UniversityHangzhou, China, 310020 The First Affliated Hospital Of Nanchang UniversityNanchang, China, 330006 Nanjing Drum Tower HospitalNanjing, China, 210008 Jiangsu Cancer HospitalNanjing, China, 210009 Renji Hospital, Shanghai Jiaotong University School Of MedicineShanghai, China, 200127 Huadong Hospital Affiliated To Fudan UniversityShanghai, China, 200400 First Affiliated Hospital, Xi'An Jiaotong UniversityXi'An, China, 710061|Angers, France, 49055 Hopital Jean MinjozBesancon Cedex, France, 25030 Institut BergoniÃ©Bordeaux, France, 33000 Centre Jean PerrinClermont Ferrand, France, 63011 Centre Georges-FranÃ§ois LeclercDijon, France, 21079 Centre Oscar LambretLille, France, 59020 Centre Leon BÃ©rardLyon, France, 69008 Hopital De La TimoneMarseille, France, 13005 Institut Regional Du Cancer De Montpellier Val D'AurelleMontpellier, France, 34298 Centre Antoine LacassagneNice, France, 06189 Institut De CancÃ©rologie Du GardNÃ®mes, France, 30029 Hospital Saint-LouisParis Cedex 10, France, 75475 Hopital Europeen Georges-PompidouParis, France, 75015 Hospices Civils De Lyon HclPierre-BÃ©nite, France, 69495 Chu De PoitiersPoitiers Cedex, France, 86021 Centre Hopitalier Inter-Communal De CornouailleQuimper, France, 29000 Centre Eugene MarquisRennes Cedex, France, 35062 I.C.O. RenÃ© GauducheauSaint Herblain Cedex, France, 44805 Institut De CancÃ©rologie De LoireSaint-Priest-En-Jarez, France, 42271 Hopitaux Universitaires De StrasbourgStrasbourg, France, 67091 Institut Claudius RegaudToulouse, France, 31059 Institut Gustave RoussyV"}},"Alaska|Arizona|California|Colorado|Florida|Georgia|Idaho|Illinois|Kentucky|Michigan|Nebraska|Nevada|New York|North Carolina|Pennsylvania|South Carolina|Texas|Virginia|Washington","Australia|Austria|Belgium|Brazil|Canada|China|France|Germany|Greece|Hungary|India|Israel|Italy|Japan|Mexico|Netherlands|Portugal|Spain|Turkey|Ukraine|United Kingdom|United States","Chris O'Brien Lifehouse|Lkh-Univ. Klinikum Graz|Olv Ziekenhuis Aalst|Fundacao Pio Xii - Hospital De Cancer De Barretos|British Columbia Bc Cancer Agency - Southern Interior|Manitoba Cancercare Manitoba|Ontario Thunder Bay Regional Health Sciences Centre|Saskatchewan Saskatchewan Cancer Agency (Sca) - Allan Blair Cancer Centre|Peking University First Hospital|Institut De CancÃ©rologie De L'Ouest (Ico)|Vivantes Klinikum Am Urban|University General Hospital Of Rio Patras|Semmelweis Egyetem|Manipal Comprehensive Cancer Centre, Manipal Hospital|Rambam Health Care Campus|Azienda Ospedaliera Nazionale Ss. Antonio E Biagio E Cesare Arrigo Alessandria|Chiba Cancer Center|San Peregrino Cancer Center|St. Antonius Ziekenhuis Nieuwegein|Hospital LusÃ­adas|Hosp. Univ. Infanta Cristina|Adana Baskent Practice And Research Hospital|Chernivtsi Regional Clinical Hospital|University Hospitals Bristol - Bristol Haematology & Oncolog|Alaska Urological Institute Dba Alaska Clinical Research Center|University Of Ua Cancer Center(Uacc)/Dh-Sjhmc|University Of California Irvine Medical Center - Chao Family Comprehensive Cancer Center|Uchealth Anschutz Cancer Pavilion|University Of Miami/Sylvester Cancer Center|Piedmont Cancer Institute|St. Luke's Meridian Medical Center|Rush University|Norton Cancer Institute|University Of Michigan Health System|University Of Nebraska Medical Center|Va Sierra Nevada Health Care System|Montefiore Medical Center|Levine Cancer Institute, Carolinas Healthcare System|Penn State Hershey Cancer Institute|University Of Missouri|The Center For Cancer And Blood Disorders|Inova Dwiight &Martha Schar Cancer Institute|Seattle Cancer Care Alliance",{"$nulls":3},"Janssen Research & Development, LLC Clinical Trials","2019-04-29","2020-05-25T16:35:13.339","2020-05-26T17:10:42.972","NCT03390504"]
["5ecbf3c1e2561b1b11905c9a","NCT03390504","2019-05-29","Johnson & Johnson","JNJ","Recruiting","A Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Participants With Advanced Urothelial Cancer and Selected Fibroblast Growth Factor Receptor (FGFR) Gene Aberrations","Erdafitinib|Fibroblast|Vinflunine|Docetaxel|Pembrolizumab","FGFR Antagonist|Tubulin Inhibitor|Mitosis Inhibitor|Tubulin Inhibitor|PD-1 Inhibitor","Yes","['Fibroblast', 'Vinflunine']","No",null,"Phase 3",4,631,"Anticipated","2018-03-23","2020-11-24","OS","Overall Survival",{"$nulls":3},"The purpose of this study is to evaluate efficacy of erdafitinib versus chemotherapy or pembrolizumab in participants with advanced urothelial cancer harboring selected fibroblast growth factor receptor (FGFR) aberrations who have progressed after 1 or 2 prior treatments, at least 1 of which includes an anti-PD-(L) 1 agent (cohort 1) or 1 prior treatment not containing an anti-PD-(L) 1 agent (cohort 2).","A study of erdafitinib versus standard of care, consisting of chemotherapy (docetaxel or vinflunine) or anti-PD-(L) 1 agent pembrolizumab, in participants with advanced urothelial cancer and selected FGFR aberrations who have progressed on or after 1 or 2 prior treatments, at least 1 of which includes an anti-PD-(L) 1 agent (cohort 1) or 1 prior treatment not containing an anti-PD-(L) 1 agent (cohort 2). It will consist of screening, treatment phase (from randomization until disease progression, intolerable toxicity, withdrawal of consent or decision by investigator to discontinue treatment, post-treatment followup (from end-of-treatment to participants death, withdraws consent, lost to follow-up, or end of study, whichever comes first). Efficacy, pharmacokinetics, biomarkers, patient reported outcomes, medical resource utilization and safety will be assessed.","A Phase 3 Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Subjects With Advanced Urothelial Cancer and Selected FGFR Gene Aberrations","CR108401","Urothelial Cancer","Transitional Cell Carcinoma","Oncology Solid Tumor","Oncology","Experimental","Cohort 1 (Arm 1A): Erdafitinib|Cohort 1 (Arm 1B): Vinflunine or Docetaxel|Cohort 2 (Arm 2A): Erdafitinib|Cohort 2 (Arm 2B): Pembrolizumab","Participants will be screened based on Fibroblast Growth Factor Receptor inhibitor Clinical Trial Assay (FGFRi CTA) to determine molecular eligibility and participants who meet molecular eligibility criteria will be eligible for full study screening. Participants enrolled in the study (treated with prior anti-programmed cell death protein PD-[L] 1 agent) will swallow erdafitinib tablets orally at a starting dose of 8 milligram (mg), once daily for 21 days in a 21-day cycle until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustment are based on phosphate level and observed toxicity (adverse events [AEs]).|Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be eligible for full study screening. Participants enrolled in the study (treated with prior anti-PD-[L] 1 agent) will receive vinflunine 320 milligram per meter square (mg/m^2) as a 20-minute intravenous infusion once every 3 weeks or docetaxel 75 mg/m^2 as a 1 hour intravenous infusion every 3 weeks. Treatment with either agent (choice of investigator) will be administered until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustments are based on observed toxicities.|Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be eligible for full study screening. Participants enrolled in the study (no prior treatment with anti-PD-[L] 1 agent) will swallow erdafitinib tablets orally at a starting dose of 8 mg, once daily for 21 days in a 21-day cycle until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustments are based on phosphate level and observed toxicity (AEs).|Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be eligible for full study screening. Participants enrolled in the study (no prior treatment with anti-PD-[L] 1 agent) will receive pembrolizumab 200 mg as a 30-minute intravenous infusion once every 3 weeks, until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustments are based on observed toxicities.","Drug|Device","Erdafitinib|Fibroblast Growth Factor Receptor inhibitor Clinical Trial Assay (FGFRi CTA)|Vinflunine|Docetaxel|Pembrolizumab","Participants will swallow erdafitinib tablets orally at a starting dose of 8 mg.|FGFRi CTA will be used to determine molecular eligibility.|Participants will receive vinflunine 320 mg/m^2 as a 20-minute intravenous infusion.|Participants will receive docetaxel 75 mg/m^2 as a 1 hour intravenous infusion.|Participants will receive pembrolizumab 200 mg as a 30-minute intravenous infusion.","JNJ-42756493","Cohort 1 (Arm 1A): Erdafitinib|Cohort 1 (Arm 1B): Vinflunine or Docetaxel|Cohort 2 (Arm 2A): Erdafitinib|Cohort 2 (Arm 2B): Pembrolizumab","\n\n * Histologic demonstration of transitional cell carcinoma of the urothelium. Minor components ( less than [<] 50 percent [%] overall) of variant histology such as glandular or squamous differentiation, or evolution to more aggressive phenotypes such as sarcomatoid or micropapillary change are acceptable\n * Metastatic or surgically unresectable urothelial cancer\n * Documented progression of disease, defined as any progression that requires a change in treatment, prior to randomization\n * Cohort 1: Prior treatment with an anti-PD-(L) 1 agent as monotherapy or as combination therapy; no more than 2 prior lines of systemic treatment. Cohort 2: No prior treatment with an anti-PD-(L) 1 agent; only 1 line of prior systemic treatment. Subjects who received neoadjuvant or adjuvant chemotherapy and showed disease progression within 12 months of the last dose are considered to have received systemic therapy in the metastatic setting.\n * A woman of childbearing potential who is sexually active must have a negative pregnancy test (beta human chorionic gonadotropin [beta hCG]) at Screening (urine or serum)\n * Participants must meet appropriate molecular eligibility criteria\n * Eastern Cooperative Oncology Group (ECOG) performance status Grade 0, 1, or 2\n * Adequate bone marrow, liver, and renal function\n\n","\n\n * Treatment with any other investigational agent or participation in another clinical study with therapeutic intent within 30 days prior to randomization\n * Active malignancies (that is, requiring treatment change in the last 24 months). The only allowed exceptions are: urothelial cancer, skin cancer treated within the last 24 months that is considered completely cured, localized prostate cancer with a gleason score of 6 (treated within the last 24 months or untreated and under surveillance) and localized prostate cancer with a gleason score of 3+4 that has been treated more than 6 months prior to full study screening and considered to have a very low risk of recurrence.\n * Symptomatic central nervous system metastases\n * Received prior fibroblast growth factor receptor (FGFR) inhibitor treatment\n * Known allergies, hypersensitivity, or intolerance to erdafitinib or its excipients\n * Current central serous retinopathy (CSR) or retinal pigment epithelial detachment of any grade.\n * History of uncontrolled cardiovascular disease\n * Impaired wound healing capacity defined as skin/decubitus ulcers, chronic leg ulcers, known gastric ulcers, or unhealed incisions",{"$nulls":4},"Actual","2018-01-04","Actual","Anticipated","2021-11-05","Anticipated","2019-05-01","2017-12-20","2018-01-03","2019-05-28","Yes",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No",null,null,"URL: http://pam.sylogent.com/cr/CR108401 [http://pam.sylogent.com/cr/CR108401] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To learn how to participate in this trial please click here.",null,"Yes","Yes",{"$nulls":17},"2017-002932-18|42756493BLC3001","EudraCT Number|Janssen Research & Development, LLC","Overall Survival (OS)","Overall survival is measured from the date of randomization to the date of the participant's death. If the participant is alive or the vital status is unknown, the participant will be censored at the date the participant was last known to be alive.","Date of first randomization to the date of participant's death (approximately up to 3 years)","Progression-free Survival (PFS)|Overall Response Rate (ORR)|Time to Worsening in Symptom Items and Functioning Subscales in Patient-Reported Health Status of the Functional Assessment of Cancer Therapy-Bladder Cancer (FACT-Bl)|Change from Baseline in Patient-Global Impression of Severity (PGIS) Score|Change from Baseline in the Visual Analog Scale (VAS) of the EQ-5D-5L|Change from Baseline in the Utility Scale of the EQ-5D-5L|Duration of Response (DOR)|Number of Participants with Adverse Events (AEs) as a Measure of Safety|Oral Clearance (CL/F) of Erdafitinib|Area Under the Plasma Concentration-Time Curve from Time Zero to Time 't' (AUC[0-t]) of Erdafitinib","PFS is defined as duration in days from date of randomization to disease progression date (assessed per Response Evaluation Criteria in Solid Tumors Version 1.1|ORR is defined as the proportion of participants who achieve CR (CR; disappearance of all target lesions and disappearance of all non-target lesions and normalization of tumor marker level) or partial response (PR; at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters), as assessed per RECIST v1.1 by the investigator.|The FACT-Bl consists of 36 core items, with 5-point Likert response scales, covering 5 primary domains: Physical well-being, social/family well-being, emotional well-being, functional well-being and bladder symptom subscale. The answer scales range from \"Not at all (score=0)\" to \"very much (score=4)\" to assess the meaningful significant symptom deterioration.|The PGIS is a single question regarding the participant report of disease severity. Participants will be asked that ''considering all aspects of your bladder cancer symptoms right now, would you say your bladder cancer symptoms are none, mild, moderate, severe, or very severe?\" The PGIS is an anchor question that will be used to establish the magnitude of meaningful change in this study by assessing disease severity.|European Quality of Life 5 Dimensions (EQ-5D) visual analog scale (VAS) is a 20 centimeter (cm) vertical VAS with scores ranging from 0 (worst imaginable health) to 100 (perfect health). A higher score indicates an improvement in health in the Health Status Index.|The EuroQol-5 is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating \"full health\" and 0 representing dead.|DOR for responders is defined as duration in days from the date of initial documentation of a response to the date of first documented evidence of progressive disease (PD) or relapse for participants who experience CR (CR; disappearance of all target lesions and disappearance of all non-target lesions and normalization of tumor marker level) during the study or death.|An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.|CL/F is the oral clearance; that is clearance based on oral bioavailability of erdafitinib.|AUC(0-t) is the area under the plasma concentration-time curve from time zero to any time 't' of erdafitinib.","RECIST v1.1 by investigator) or relapse from CR or death, whichever is reported first. RECIST 1.1, progressive disease is defined as a 20 percent (%) increase in the sum of diameters of all target lesions and a minimum absolute increase of 5 millimeter (mm) in the sum. CR is defined as disappearance of all target lesions, non-target lesions and normalization of tumor marker level.|Approximately up to 3 years|Baseline up to end of treatment (approximately 3 years)|Baseline up to follow up phase (approximately 3 years)|From the date of initial documentation of a response to date of first documented evidence of progressive disease (or participants relapse who experience CR during the study) or death (approximately up to 3 years)|Day 14 (Cycle 1), Day 1 (Cycle 2) (each cycle is of 21 days)","JNJ.CT@sylogent.com","Study Contact","844-434-4210",{"$cut":{"chars":17363,"head":"Camperdown, Australia, 2050 Peninsula & South Eastern Haematology And Oncology GroupFrankston, Australia, 3199 Royal Hobart HospitalHobart, Australia, 7000 St. George Private Hospital, Oncology Day Care CentreKogarah, Australia, 2217 Peter Maccallum Cancer CentreMelbourne, Australia, 3000 Frankston HospitalMelbourne, Australia, 3199 Fiona Stanley HospitalMurdoch, Australia, 6150|Graz, Austria, 8036 Krankenhaus Der Barmherzigen SchwesternLinz, Austria, 4010 Lkh - UniversitÃ¤tsklinikum Der Pmu SalzburgSalzburg, Austria, 5020 Medical University Vienna, MuvVienna, Austria, A-1090|Aalst, Belgium, 9300 Zna MiddelheimAntwerpen, Belgium, 2020 Cliniques Universitaires Saint-LucBrussel, Belgium, 1200 Clinique Notre Dame De GrÃ¢ceCharleroi, Belgium, 6000 Az Maria MiddelaresGent, Belgium, 9000 Uz GentGent, Belgium, 9000 Chc-Cliniques Saint-JosephLiÃ¨ge, Belgium, 4000 Sint-Augustinus AzWilrijk, Belgium, 2610 Chu Dinant Godinne Ucl NamurYvoir, Belgium, 5530|Barretos, Brazil, 14784-400 AssociaÃ§Ã£o MÃ¡rio Penna\\NÃºcleo De Ensino E PesquisasBelo Horizonte, Brazil, 30380-472 Hospital Erasto GaertnerCuritiba, Brazil, 81520-060 ClÃ­nica De Neoplasias Litoral Ltda.Itajai, Brazil, 88301-220 Upco - HcpaPorto Alegre, Brazil, 90035-903 Inca - Instituto Nacional Do CancerRio De Janeiro, Brazil, 20231-050 Fundacao Antonio PrudenteSao Paulo, Brazil, 01509900 Hospital De Base De SÃ£o JosÃ© Do Rio PretoSÃ£o JosÃ© Do Rio Preto, Brazil, 15090-000 Sociedade Beneficiante De Senhoras - Hospital Sirio LibanesSÃ£o Paulo, Brazil, 01308901 Cepho - Faculdade De Medicina Do AbcSÃ£o Paulo, Brazil, 09060-650|Kelowna, British Columbia, Canada, V1Y 5L3 Vancouver Cancer CentreVancouver, British Columbia, Canada, V5Z 4E6|Winnipeg, Manitoba, Canada, R3E 0V9|Thunder Bay, Ontario, Canada, P7B 6V4 Princess Margaret Hospital- UhnToronto, Ontario, Canada, M5G 2M9|Regina, Saskatchewan, Canada, S4T 7T1|Beijing, China, 100034 Beijing Friendship HospitalBeijing, China, 100050 Peking University Third HospitalBeijing, China, 100191 Beijing HospitalBeijing, China, 100730 Peking Union Medical College HospitalBeijing, China, 100730 Sichuan Provincial People'S HospitalChengdu, China, 610000 Chongqing Medical UniversityChongqing, China, 400030 Sun Yat-Sen University Cancer CenterGuangzhou, China, 510060 Sun Yat-Sen Memorial Hospital, Sun Yat-Sen UniversityGuangzhou, China, 510120 Guangzhou First Municipal People'S HospitalGuangzhou, China, 510180 Zhejiang Provincial People'S HospitalHangzhou, China, 310000 Sir Run Run Shaw Hospital, Zhejiang UniversityHangzhou, China, 310020 The First Affliated Hospital Of Nanchang UniversityNanchang, China, 330006 Nanjing Drum Tower HospitalNanjing, China, 210008 Jiangsu Cancer HospitalNanjing, China, 210009 Renji Hospital, Shanghai Jiaotong University School Of MedicineShanghai, China, 200127 Huadong Hospital Affiliated To Fudan UniversityShanghai, China, 200400 First Affiliated Hospital, Xi'An Jiaotong UniversityXi'An, China, 710061|Angers, France, 49055 Hopital Jean MinjozBesancon Cedex, France, 25030 Institut BergoniÃ©Bordeaux, France, 33000 Centre Jean PerrinClermont Ferrand, France, 63011 Centre Georges-FranÃ§ois LeclercDijon, France, 21079 Centre Oscar LambretLille, France, 59020 Centre Leon BÃ©rardLyon, France, 69008 Hopital De La TimoneMarseille, France, 13005 Institut Regional Du Cancer De Montpellier Val D'AurelleMontpellier, France, 34298 Centre Antoine LacassagneNice, France, 06189 Institut De CancÃ©rologie Du GardNÃ®mes, France, 30029 Hospital Saint-LouisParis Cedex 10, France, 75475 Hopital Europeen Georges-PompidouParis, France, 75015 Hospices Civils De Lyon HclPierre-BÃ©nite, France, 69495 Chu De PoitiersPoitiers Cedex, France, 86021 Centre Hopitalier Inter-Communal De CornouailleQuimper, France, 29000 Centre Eugene MarquisRennes Cedex, France, 35062 I.C.O. RenÃ© GauducheauSaint Herblain Cedex, France, 44805 Institut De CancÃ©rologie De LoireSaint-Priest-En-Jarez, France, 42271 Hopitaux Universitaires De StrasbourgStrasbourg, France, 67091 Institut Claudius RegaudToulouse, France, 31059 Centre Les DentellieresValenciennes, France, "}},"Alaska|Arizona|California|Colorado|Florida|Georgia|Idaho|Illinois|Kentucky|Michigan|Nebraska|Nevada|New York|North Carolina|Pennsylvania|South Carolina|Texas|Virginia|Washington","Australia|Austria|Belgium|Brazil|Canada|China|France|Germany|Greece|Hungary|India|Israel|Italy|Japan|Mexico|Netherlands|Portugal|Spain|Turkey|Ukraine|United Kingdom|United States","Chris O'Brien Lifehouse|Lkh-Univ. Klinikum Graz|Olv Ziekenhuis Aalst|Fundacao Pio Xii - Hospital De Cancer De Barretos|British Columbia Bc Cancer Agency - Southern Interior|Manitoba Cancercare Manitoba|Ontario Thunder Bay Regional Health Sciences Centre|Saskatchewan Saskatchewan Cancer Agency (Sca) - Allan Blair Cancer Centre|Peking University First Hospital|Institut De CancÃ©rologie De L'Ouest (Ico)|Vivantes Klinikum Am Urban|University General Hospital Of Rio Patras|Semmelweis Egyetem|Manipal Comprehensive Cancer Centre, Manipal Hospital|Rambam Health Care Campus|Azienda Ospedaliera Nazionale Ss. Antonio E Biagio E Cesare Arrigo Alessandria|Chiba Cancer Center|San Peregrino Cancer Center|St. Antonius Ziekenhuis Nieuwegein|Hospital LusÃ­adas|Hosp. Univ. Infanta Cristina|Adana Baskent Practice And Research Hospital|Chernivtsi Regional Clinical Hospital|University Hospitals Bristol - Bristol Haematology & Oncolog|Alaska Urological Institute Dba Alaska Clinical Research Center|University Of Ua Cancer Center(Uacc)/Dh-Sjhmc|University Of California Irvine Medical Center - Chao Family Comprehensive Cancer Center|Uchealth Anschutz Cancer Pavilion|University Of Miami/Sylvester Cancer Center|Piedmont Cancer Institute|St. Luke's Meridian Medical Center|Rush University|Norton Cancer Institute|University Of Michigan Health System|University Of Nebraska Medical Center|Va Sierra Nevada Health Care System|Montefiore Medical Center|Levine Cancer Institute, Carolinas Healthcare System|Penn State Hershey Cancer Institute|University Of Missouri|The Center For Cancer And Blood Disorders|Inova Dwiight &Martha Schar Cancer Institute|Seattle Cancer Care Alliance",{"$nulls":3},"Janssen Research & Development, LLC Clinical Trials","2019-05-28","2020-05-25T16:35:13.345","2020-05-26T17:10:42.972","NCT03390504"]
["5ecbf3c111702c1b1b9169b3","NCT03390504","2019-06-28","Johnson & Johnson","JNJ","Recruiting","A Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Participants With Advanced Urothelial Cancer and Selected Fibroblast Growth Factor Receptor (FGFR) Gene Aberrations","Erdafitinib|Fibroblast|Vinflunine|Docetaxel|Pembrolizumab","FGFR Antagonist|Tubulin Inhibitor|Mitosis Inhibitor|Tubulin Inhibitor|PD-1 Inhibitor","Yes","['Fibroblast', 'Vinflunine']","No",null,"Phase 3",4,631,"Anticipated","2018-03-23","2020-11-24","OS","Overall Survival",{"$nulls":3},"The purpose of this study is to evaluate efficacy of erdafitinib versus chemotherapy or pembrolizumab in participants with advanced urothelial cancer harboring selected fibroblast growth factor receptor (FGFR) aberrations who have progressed after 1 or 2 prior treatments, at least 1 of which includes an anti-PD-(L) 1 agent (cohort 1) or 1 prior treatment not containing an anti-PD-(L) 1 agent (cohort 2).","A study of erdafitinib versus standard of care, consisting of chemotherapy (docetaxel or vinflunine) or anti-PD-(L) 1 agent pembrolizumab, in participants with advanced urothelial cancer and selected FGFR aberrations who have progressed on or after 1 or 2 prior treatments, at least 1 of which includes an anti-PD-(L) 1 agent (cohort 1) or 1 prior treatment not containing an anti-PD-(L) 1 agent (cohort 2). It will consist of screening, treatment phase (from randomization until disease progression, intolerable toxicity, withdrawal of consent or decision by investigator to discontinue treatment, post-treatment followup (from end-of-treatment to participants death, withdraws consent, lost to follow-up, or end of study, whichever comes first). Efficacy, pharmacokinetics, biomarkers, patient reported outcomes, medical resource utilization and safety will be assessed.","A Phase 3 Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Subjects With Advanced Urothelial Cancer and Selected FGFR Gene Aberrations","CR108401","Urothelial Cancer","Transitional Cell Carcinoma","Oncology Solid Tumor","Oncology","Experimental","Cohort 1 (Arm 1A): Erdafitinib|Cohort 1 (Arm 1B): Vinflunine or Docetaxel|Cohort 2 (Arm 2A): Erdafitinib|Cohort 2 (Arm 2B): Pembrolizumab","Participants will be screened based on Fibroblast Growth Factor Receptor inhibitor Clinical Trial Assay (FGFRi CTA) to determine molecular eligibility and participants who meet molecular eligibility criteria will be eligible for full study screening. Participants enrolled in the study (treated with prior anti-programmed cell death protein PD-[L] 1 agent) will swallow erdafitinib tablets orally at a starting dose of 8 milligram (mg), once daily for 21 days in a 21-day cycle until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustment are based on phosphate level and observed toxicity (adverse events [AEs]).|Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be eligible for full study screening. Participants enrolled in the study (treated with prior anti-PD-[L] 1 agent) will receive vinflunine 320 milligram per meter square (mg/m^2) as a 20-minute intravenous infusion once every 3 weeks or docetaxel 75 mg/m^2 as a 1 hour intravenous infusion every 3 weeks. Treatment with either agent (choice of investigator) will be administered until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustments are based on observed toxicities.|Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be eligible for full study screening. Participants enrolled in the study (no prior treatment with anti-PD-[L] 1 agent) will swallow erdafitinib tablets orally at a starting dose of 8 mg, once daily for 21 days in a 21-day cycle until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustments are based on phosphate level and observed toxicity (AEs).|Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be eligible for full study screening. Participants enrolled in the study (no prior treatment with anti-PD-[L] 1 agent) will receive pembrolizumab 200 mg as a 30-minute intravenous infusion once every 3 weeks, until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustments are based on observed toxicities.","Drug|Device","Erdafitinib|Fibroblast Growth Factor Receptor inhibitor Clinical Trial Assay (FGFRi CTA)|Vinflunine|Docetaxel|Pembrolizumab","Participants will swallow erdafitinib tablets orally at a starting dose of 8 mg.|FGFRi CTA will be used to determine molecular eligibility.|Participants will receive vinflunine 320 mg/m^2 as a 20-minute intravenous infusion.|Participants will receive docetaxel 75 mg/m^2 as a 1 hour intravenous infusion.|Participants will receive pembrolizumab 200 mg as a 30-minute intravenous infusion.","JNJ-42756493","Cohort 1 (Arm 1A): Erdafitinib|Cohort 1 (Arm 1B): Vinflunine or Docetaxel|Cohort 2 (Arm 2A): Erdafitinib|Cohort 2 (Arm 2B): Pembrolizumab","\n\n * Histologic demonstration of transitional cell carcinoma of the urothelium. Minor components ( less than [<] 50 percent [%] overall) of variant histology such as glandular or squamous differentiation, or evolution to more aggressive phenotypes such as sarcomatoid or micropapillary change are acceptable\n * Metastatic or surgically unresectable urothelial cancer\n * Documented progression of disease, defined as any progression that requires a change in treatment, prior to randomization\n * Cohort 1: Prior treatment with an anti-PD-(L) 1 agent as monotherapy or as combination therapy; no more than 2 prior lines of systemic treatment. Cohort 2: No prior treatment with an anti-PD-(L) 1 agent; only 1 line of prior systemic treatment. Subjects who received neoadjuvant or adjuvant chemotherapy and showed disease progression within 12 months of the last dose are considered to have received systemic therapy in the metastatic setting.\n * A woman of childbearing potential who is sexually active must have a negative pregnancy test (beta human chorionic gonadotropin [beta hCG]) at Screening (urine or serum)\n * Participants must meet appropriate molecular eligibility criteria\n * Eastern Cooperative Oncology Group (ECOG) performance status Grade 0, 1, or 2\n * Adequate bone marrow, liver, and renal function\n\n","\n\n * Treatment with any other investigational agent or participation in another clinical study with therapeutic intent within 30 days prior to randomization\n * Active malignancies (that is, requiring treatment change in the last 24 months). The only allowed exceptions are: urothelial cancer, skin cancer treated within the last 24 months that is considered completely cured, localized prostate cancer with a gleason score of 6 (treated within the last 24 months or untreated and under surveillance) and localized prostate cancer with a gleason score of 3+4 that has been treated more than 6 months prior to full study screening and considered to have a very low risk of recurrence.\n * Symptomatic central nervous system metastases\n * Received prior fibroblast growth factor receptor (FGFR) inhibitor treatment\n * Known allergies, hypersensitivity, or intolerance to erdafitinib or its excipients\n * Current central serous retinopathy (CSR) or retinal pigment epithelial detachment of any grade.\n * History of uncontrolled cardiovascular disease\n * Impaired wound healing capacity defined as skin/decubitus ulcers, chronic leg ulcers, known gastric ulcers, or unhealed incisions",{"$nulls":4},"Actual","2018-01-04","Actual","Anticipated","2021-11-05","Anticipated","2019-06-01","2017-12-20","2018-01-03","2019-06-27","Yes",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No",null,null,"URL: http://pam.sylogent.com/cr/CR108401 [http://pam.sylogent.com/cr/CR108401] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To learn how to participate in this trial please click here.",null,"Yes","Yes",{"$nulls":17},"2017-002932-18|42756493BLC3001","EudraCT Number|Janssen Research & Development, LLC","Overall Survival (OS)","Overall survival is measured from the date of randomization to the date of the participant's death. If the participant is alive or the vital status is unknown, the participant will be censored at the date the participant was last known to be alive.","Date of first randomization to the date of participant's death (approximately up to 3 years)","Progression-free Survival (PFS)|Overall Response Rate (ORR)|Time to Worsening in Symptom Items and Functioning Subscales in Patient-Reported Health Status of the Functional Assessment of Cancer Therapy-Bladder Cancer (FACT-Bl)|Change from Baseline in Patient-Global Impression of Severity (PGIS) Score|Change from Baseline in the Visual Analog Scale (VAS) of the EQ-5D-5L|Change from Baseline in the Utility Scale of the EQ-5D-5L|Duration of Response (DOR)|Number of Participants with Adverse Events (AEs) as a Measure of Safety|Oral Clearance (CL/F) of Erdafitinib|Area Under the Plasma Concentration-Time Curve from Time Zero to Time 't' (AUC[0-t]) of Erdafitinib","PFS is defined as duration in days from date of randomization to disease progression date (assessed per Response Evaluation Criteria in Solid Tumors Version 1.1|ORR is defined as the proportion of participants who achieve CR (CR; disappearance of all target lesions and disappearance of all non-target lesions and normalization of tumor marker level) or partial response (PR; at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters), as assessed per RECIST v1.1 by the investigator.|The FACT-Bl consists of 36 core items, with 5-point Likert response scales, covering 5 primary domains: Physical well-being, social/family well-being, emotional well-being, functional well-being and bladder symptom subscale. The answer scales range from \"Not at all (score=0)\" to \"very much (score=4)\" to assess the meaningful significant symptom deterioration.|The PGIS is a single question regarding the participant report of disease severity. Participants will be asked that ''considering all aspects of your bladder cancer symptoms right now, would you say your bladder cancer symptoms are none, mild, moderate, severe, or very severe?\" The PGIS is an anchor question that will be used to establish the magnitude of meaningful change in this study by assessing disease severity.|European Quality of Life 5 Dimensions (EQ-5D) visual analog scale (VAS) is a 20 centimeter (cm) vertical VAS with scores ranging from 0 (worst imaginable health) to 100 (perfect health). A higher score indicates an improvement in health in the Health Status Index.|The EuroQol-5 is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating \"full health\" and 0 representing dead.|DOR for responders is defined as duration in days from the date of initial documentation of a response to the date of first documented evidence of progressive disease (PD) or relapse for participants who experience CR (CR; disappearance of all target lesions and disappearance of all non-target lesions and normalization of tumor marker level) during the study or death.|An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.|CL/F is the oral clearance; that is clearance based on oral bioavailability of erdafitinib.|AUC(0-t) is the area under the plasma concentration-time curve from time zero to any time 't' of erdafitinib.","RECIST v1.1 by investigator) or relapse from CR or death, whichever is reported first. RECIST 1.1, progressive disease is defined as a 20 percent (%) increase in the sum of diameters of all target lesions and a minimum absolute increase of 5 millimeter (mm) in the sum. CR is defined as disappearance of all target lesions, non-target lesions and normalization of tumor marker level.|Approximately up to 3 years|Baseline up to end of treatment (approximately 3 years)|Baseline up to follow up phase (approximately 3 years)|From the date of initial documentation of a response to date of first documented evidence of progressive disease (or participants relapse who experience CR during the study) or death (approximately up to 3 years)|Day 14 (Cycle 1), Day 1 (Cycle 2) (each cycle is of 21 days)","JNJ.CT@sylogent.com","Study Contact","844-434-4210",{"$cut":{"chars":17604,"head":"Camperdown, Australia, 2050 Peninsula & South Eastern Haematology And Oncology GroupFrankston, Australia, 3199 Royal Hobart HospitalHobart, Australia, 7000 St. George Private Hospital, Oncology Day Care CentreKogarah, Australia, 2217 Peter Maccallum Cancer CentreMelbourne, Australia, 3000 Frankston HospitalMelbourne, Australia, 3199 Fiona Stanley HospitalMurdoch, Australia, 6150|Graz, Austria, 8036 Ordensklinikum Linz Gmbh ElisabethinenLinz, Austria, 4020 Lkh - UniversitÃ¤tsklinikum Der Pmu SalzburgSalzburg, Austria, 5020 Medical University Vienna, MuvVienna, Austria, A-1090|Aalst, Belgium, 9300 Zna MiddelheimAntwerpen, Belgium, 2020 Cliniques Universitaires Saint-LucBrussel, Belgium, 1200 Clinique Notre Dame De GrÃ¢ceCharleroi, Belgium, 6000 Az Maria MiddelaresGent, Belgium, 9000 Uz GentGent, Belgium, 9000 Chc-Cliniques Saint-JosephLiÃ¨ge, Belgium, 4000 Sint-Augustinus AzWilrijk, Belgium, 2610 Chu Dinant Godinne Ucl NamurYvoir, Belgium, 5530|Barretos, Brazil, 14784-400 AssociaÃ§Ã£o MÃ¡rio Penna\\NÃºcleo De Ensino E PesquisasBelo Horizonte, Brazil, 30380-472 Hospital Erasto GaertnerCuritiba, Brazil, 81520-060 ClÃ­nica De Neoplasias Litoral Ltda.Itajai, Brazil, 88301-220 Upco - HcpaPorto Alegre, Brazil, 90035-903 Inca - Instituto Nacional Do CancerRio De Janeiro, Brazil, 20231-050 Fundacao Antonio PrudenteSao Paulo, Brazil, 01509900 Hospital De Base De SÃ£o JosÃ© Do Rio PretoSÃ£o JosÃ© Do Rio Preto, Brazil, 15090-000 Sociedade Beneficiante De Senhoras - Hospital Sirio LibanesSÃ£o Paulo, Brazil, 01308901 Cepho - Faculdade De Medicina Do AbcSÃ£o Paulo, Brazil, 09060-650|Kelowna, British Columbia, Canada, V1Y 5L3 Vancouver Cancer CentreVancouver, British Columbia, Canada, V5Z 4E6|Winnipeg, Manitoba, Canada, R3E 0V9|Thunder Bay, Ontario, Canada, P7B 6V4 Princess Margaret Hospital- UhnToronto, Ontario, Canada, M5G 2M9|Regina, Saskatchewan, Canada, S4T 7T1|Beijing, China, 100021 Peking University First HospitalBeijing, China, 100034 Beijing Friendship HospitalBeijing, China, 100050 Peking University Third HospitalBeijing, China, 100191 Beijing HospitalBeijing, China, 100730 Peking Union Medical College HospitalBeijing, China, 100730 Sichuan Provincial People'S HospitalChengdu, China, 610000 Chongqing Medical UniversityChongqing, China, 400030 Sun Yat-Sen University Cancer CenterGuangzhou, China, 510060 Sun Yat-Sen Memorial Hospital, Sun Yat-Sen UniversityGuangzhou, China, 510120 Guangzhou First Municipal People'S HospitalGuangzhou, China, 510180 Zhejiang Provincial People'S HospitalHangzhou, China, 310000 Sir Run Run Shaw Hospital, Zhejiang UniversityHangzhou, China, 310020 The First Affliated Hospital Of Nanchang UniversityNanchang, China, 330006 Nanjing Drum Tower HospitalNanjing, China, 210008 Jiangsu Cancer HospitalNanjing, China, 210009 Renji Hospital, Shanghai Jiaotong University School Of MedicineShanghai, China, 200127 Huadong Hospital Affiliated To Fudan UniversityShanghai, China, 200400 Shengjing Hospital Of|Shenyang, China, 110004 First Affiliated Hospital, Xi'An Jiaotong UniversityXi'An, China, 710061|Angers, France, 49055 Hopital Jean MinjozBesancon Cedex, France, 25030 Institut BergoniÃ©Bordeaux, France, 33000 Centre Jean PerrinClermont Ferrand, France, 63011 Centre Georges-FranÃ§ois LeclercDijon, France, 21079 Centre Oscar LambretLille, France, 59020 Centre Leon BÃ©rardLyon, France, 69008 Hopital De La TimoneMarseille, France, 13005 Institut Regional Du Cancer De Montpellier Val D'AurelleMontpellier, France, 34298 Centre Antoine LacassagneNice, France, 06189 Institut De CancÃ©rologie Du GardNÃ®mes, France, 30029 Hospital Saint-LouisParis Cedex 10, France, 75475 Hopital Europeen Georges-PompidouParis, France, 75015 Hospices Civils De Lyon HclPierre-BÃ©nite, France, 69495 Chu De PoitiersPoitiers Cedex, France, 86021 Centre Hopitalier Inter-Communal De CornouailleQuimper, France, 29000 Centre Eugene MarquisRennes Cedex, France, 35062 I.C.O. RenÃ© GauducheauSaint Herblain Cedex, France, 44805 Institut De CancÃ©rologie De LoireSaint-Priest-En-Jarez, France, 42271 Hopitaux Universitaires De StrasbourgStrasbourg, France,"}},"Alaska|Arizona|California|Colorado|Florida|Georgia|Idaho|Illinois|Kentucky|Michigan|Nebraska|Nevada|New York|North Carolina|Pennsylvania|South Carolina|Texas|Virginia|Washington","Australia|Austria|Belgium|Brazil|Canada|China|France|Germany|Greece|Hungary|India|Israel|Italy|Japan|Mexico|Netherlands|Portugal|Spain|Turkey|Ukraine|United Kingdom|United States","Chris O'Brien Lifehouse|Lkh-Univ. Klinikum Graz|Olv Ziekenhuis Aalst|Fundacao Pio Xii - Hospital De Cancer De Barretos|British Columbia Bc Cancer Agency - Southern Interior|Manitoba Cancercare Manitoba|Ontario Thunder Bay Regional Health Sciences Centre|Saskatchewan Saskatchewan Cancer Agency (Sca) - Allan Blair Cancer Centre|Cancer Hospital Chinese Academy Of Medical Sciences|Medical University|Institut De CancÃ©rologie De L'Ouest (Ico)|Vivantes Klinikum Am Urban|University General Hospital Of Rio Patras|Semmelweis Egyetem|Manipal Comprehensive Cancer Centre, Manipal Hospital|Rambam Health Care Campus|Azienda Ospedaliera Nazionale Ss. Antonio E Biagio E Cesare Arrigo Alessandria|Chiba Cancer Center|San Peregrino Cancer Center|St. Antonius Ziekenhuis Nieuwegein|Hospital LusÃ­adas|Hosp. Univ. Infanta Cristina|Baskent University Adana Practice And Research Center Kisla Health Campus|Chernivtsi Regional Clinical Hospital|University Hospitals Bristol - Bristol Haematology & Oncolog|Alaska Urological Institute Dba Alaska Clinical Research Center|University Of Ua Cancer Center(Uacc)/Dh-Sjhmc|University Of California Irvine Medical Center - Chao Family Comprehensive Cancer Center|Uchealth Anschutz Cancer Pavilion|University Of Miami/Sylvester Cancer Center|Piedmont Cancer Institute|St. Luke's Meridian Medical Center|Rush University|Norton Cancer Institute|University Of Michigan Health System|University Of Nebraska Medical Center|Va Sierra Nevada Health Care System|Montefiore Medical Center|Levine Cancer Institute, Carolinas Healthcare System|Penn State Hershey Cancer Institute|University Of Missouri|The Center For Cancer And Blood Disorders|Inova Dwiight &Martha Schar Cancer Institute|Seattle Cancer Care Alliance",{"$nulls":3},"Janssen Research & Development, LLC Clinical Trials","2019-06-27","2020-05-25T16:35:13.879","2020-05-26T17:10:42.972","NCT03390504"]
["5ecbf3c1307e3d1b1f8d9c2f","NCT03390504","2019-07-26","Johnson & Johnson","JNJ","Recruiting","A Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Participants With Advanced Urothelial Cancer and Selected Fibroblast Growth Factor Receptor (FGFR) Gene Aberrations","Erdafitinib|Fibroblast|Vinflunine|Docetaxel|Pembrolizumab","FGFR Antagonist|Tubulin Inhibitor|Mitosis Inhibitor|Tubulin Inhibitor|PD-1 Inhibitor","Yes","['Fibroblast', 'Vinflunine']","No",null,"Phase 3",4,631,"Anticipated","2018-03-23","2020-11-24","OS","Overall Survival",{"$nulls":3},"The purpose of this study is to evaluate efficacy of erdafitinib versus chemotherapy or pembrolizumab in participants with advanced urothelial cancer harboring selected fibroblast growth factor receptor (FGFR) aberrations who have progressed after 1 or 2 prior treatments, at least 1 of which includes an anti-PD-(L) 1 agent (cohort 1) or 1 prior treatment not containing an anti-PD-(L) 1 agent (cohort 2).","A study of erdafitinib versus standard of care, consisting of chemotherapy (docetaxel or vinflunine) or anti-PD-(L) 1 agent pembrolizumab, in participants with advanced urothelial cancer and selected FGFR aberrations who have progressed on or after 1 or 2 prior treatments, at least 1 of which includes an anti-PD-(L) 1 agent (cohort 1) or 1 prior treatment not containing an anti-PD-(L) 1 agent (cohort 2). It will consist of screening, treatment phase (from randomization until disease progression, intolerable toxicity, withdrawal of consent or decision by investigator to discontinue treatment, post-treatment followup (from end-of-treatment to participants death, withdraws consent, lost to follow-up, or end of study, whichever comes first). Efficacy, pharmacokinetics, biomarkers, patient reported outcomes, medical resource utilization and safety will be assessed.","A Phase 3 Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Subjects With Advanced Urothelial Cancer and Selected FGFR Gene Aberrations","CR108401","Urothelial Cancer","Transitional Cell Carcinoma","Oncology Solid Tumor","Oncology","Experimental","Cohort 1 (Arm 1A): Erdafitinib|Cohort 1 (Arm 1B): Vinflunine or Docetaxel|Cohort 2 (Arm 2A): Erdafitinib|Cohort 2 (Arm 2B): Pembrolizumab","Participants will be screened based on Fibroblast Growth Factor Receptor inhibitor Clinical Trial Assay (FGFRi CTA) to determine molecular eligibility and participants who meet molecular eligibility criteria will be eligible for full study screening. Participants enrolled in the study (treated with prior anti-programmed cell death protein PD-[L] 1 agent) will swallow erdafitinib tablets orally at a starting dose of 8 milligram (mg), once daily for 21 days in a 21-day cycle until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustment are based on phosphate level and observed toxicity (adverse events [AEs]).|Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be eligible for full study screening. Participants enrolled in the study (treated with prior anti-PD-[L] 1 agent) will receive vinflunine 320 milligram per meter square (mg/m^2) as a 20-minute intravenous infusion once every 3 weeks or docetaxel 75 mg/m^2 as a 1 hour intravenous infusion every 3 weeks. Treatment with either agent (choice of investigator) will be administered until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustments are based on observed toxicities.|Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be eligible for full study screening. Participants enrolled in the study (no prior treatment with anti-PD-[L] 1 agent) will swallow erdafitinib tablets orally at a starting dose of 8 mg, once daily for 21 days in a 21-day cycle until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustments are based on phosphate level and observed toxicity (AEs).|Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be eligible for full study screening. Participants enrolled in the study (no prior treatment with anti-PD-[L] 1 agent) will receive pembrolizumab 200 mg as a 30-minute intravenous infusion once every 3 weeks, until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustments are based on observed toxicities.","Drug|Device","Erdafitinib|Fibroblast Growth Factor Receptor inhibitor Clinical Trial Assay (FGFRi CTA)|Vinflunine|Docetaxel|Pembrolizumab","Participants will swallow erdafitinib tablets orally at a starting dose of 8 mg.|FGFRi CTA will be used to determine molecular eligibility.|Participants will receive vinflunine 320 mg/m^2 as a 20-minute intravenous infusion.|Participants will receive docetaxel 75 mg/m^2 as a 1 hour intravenous infusion.|Participants will receive pembrolizumab 200 mg as a 30-minute intravenous infusion.","JNJ-42756493","Cohort 1 (Arm 1A): Erdafitinib|Cohort 1 (Arm 1B): Vinflunine or Docetaxel|Cohort 2 (Arm 2A): Erdafitinib|Cohort 2 (Arm 2B): Pembrolizumab","\n\n * Histologic demonstration of transitional cell carcinoma of the urothelium. Minor components ( less than [<] 50 percent [%] overall) of variant histology such as glandular or squamous differentiation, or evolution to more aggressive phenotypes such as sarcomatoid or micropapillary change are acceptable\n * Metastatic or surgically unresectable urothelial cancer\n * Documented progression of disease, defined as any progression that requires a change in treatment, prior to randomization\n * Cohort 1: Prior treatment with an anti-PD-(L) 1 agent as monotherapy or as combination therapy; no more than 2 prior lines of systemic treatment. Cohort 2: No prior treatment with an anti-PD-(L) 1 agent; only 1 line of prior systemic treatment. Subjects who received neoadjuvant or adjuvant chemotherapy and showed disease progression within 12 months of the last dose are considered to have received systemic therapy in the metastatic setting.\n * A woman of childbearing potential who is sexually active must have a negative pregnancy test (beta human chorionic gonadotropin [beta hCG]) at Screening (urine or serum)\n * Participants must meet appropriate molecular eligibility criteria\n * Eastern Cooperative Oncology Group (ECOG) performance status Grade 0, 1, or 2\n * Adequate bone marrow, liver, and renal function\n\n","\n\n * Treatment with any other investigational agent or participation in another clinical study with therapeutic intent within 30 days prior to randomization\n * Active malignancies (that is, requiring treatment change in the last 24 months). The only allowed exceptions are: urothelial cancer, skin cancer treated within the last 24 months that is considered completely cured, localized prostate cancer with a gleason score of 6 (treated within the last 24 months or untreated and under surveillance) and localized prostate cancer with a gleason score of 3+4 that has been treated more than 6 months prior to full study screening and considered to have a very low risk of recurrence.\n * Symptomatic central nervous system metastases\n * Received prior fibroblast growth factor receptor (FGFR) inhibitor treatment\n * Known allergies, hypersensitivity, or intolerance to erdafitinib or its excipients\n * Current central serous retinopathy (CSR) or retinal pigment epithelial detachment of any grade.\n * History of uncontrolled cardiovascular disease\n * Impaired wound healing capacity defined as skin/decubitus ulcers, chronic leg ulcers, known gastric ulcers, or unhealed incisions",{"$nulls":4},"Actual","2018-01-04","Actual","Anticipated","2021-11-05","Anticipated","2019-07-01","2017-12-20","2018-01-03","2019-07-25","Yes",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No",null,null,"URL: http://pam.sylogent.com/cr/CR108401 [http://pam.sylogent.com/cr/CR108401] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To learn how to participate in this trial please click here.",null,"Yes","Yes",{"$nulls":17},"2017-002932-18|42756493BLC3001","EudraCT Number|Janssen Research & Development, LLC","Overall Survival (OS)","Overall survival is measured from the date of randomization to the date of the participant's death. If the participant is alive or the vital status is unknown, the participant will be censored at the date the participant was last known to be alive.","Date of first randomization to the date of participant's death (approximately up to 3 years)","Progression-free Survival (PFS)|Overall Response Rate (ORR)|Time to Worsening in Symptom Items and Functioning Subscales in Patient-Reported Health Status of the Functional Assessment of Cancer Therapy-Bladder Cancer (FACT-Bl)|Change from Baseline in Patient-Global Impression of Severity (PGIS) Score|Change from Baseline in the Visual Analog Scale (VAS) of the EQ-5D-5L|Change from Baseline in the Utility Scale of the EQ-5D-5L|Duration of Response (DOR)|Number of Participants with Adverse Events (AEs) as a Measure of Safety|Oral Clearance (CL/F) of Erdafitinib|Area Under the Plasma Concentration-Time Curve from Time Zero to Time 't' (AUC[0-t]) of Erdafitinib","PFS is defined as duration in days from date of randomization to disease progression date (assessed per Response Evaluation Criteria in Solid Tumors Version 1.1|ORR is defined as the proportion of participants who achieve CR (CR; disappearance of all target lesions and disappearance of all non-target lesions and normalization of tumor marker level) or partial response (PR; at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters), as assessed per RECIST v1.1 by the investigator.|The FACT-Bl consists of 36 core items, with 5-point Likert response scales, covering 5 primary domains: Physical well-being, social/family well-being, emotional well-being, functional well-being and bladder symptom subscale. The answer scales range from \"Not at all (score=0)\" to \"very much (score=4)\" to assess the meaningful significant symptom deterioration.|The PGIS is a single question regarding the participant report of disease severity. Participants will be asked that ''considering all aspects of your bladder cancer symptoms right now, would you say your bladder cancer symptoms are none, mild, moderate, severe, or very severe?\" The PGIS is an anchor question that will be used to establish the magnitude of meaningful change in this study by assessing disease severity.|European Quality of Life 5 Dimensions (EQ-5D) visual analog scale (VAS) is a 20 centimeter (cm) vertical VAS with scores ranging from 0 (worst imaginable health) to 100 (perfect health). A higher score indicates an improvement in health in the Health Status Index.|The EuroQol-5 is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating \"full health\" and 0 representing dead.|DOR for responders is defined as duration in days from the date of initial documentation of a response to the date of first documented evidence of progressive disease (PD) or relapse for participants who experience CR (CR; disappearance of all target lesions and disappearance of all non-target lesions and normalization of tumor marker level) during the study or death.|An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.|CL/F is the oral clearance; that is clearance based on oral bioavailability of erdafitinib.|AUC(0-t) is the area under the plasma concentration-time curve from time zero to any time 't' of erdafitinib.","RECIST v1.1 by investigator) or relapse from CR or death, whichever is reported first. RECIST 1.1, progressive disease is defined as a 20 percent (%) increase in the sum of diameters of all target lesions and a minimum absolute increase of 5 millimeter (mm) in the sum. CR is defined as disappearance of all target lesions, non-target lesions and normalization of tumor marker level.|Approximately up to 3 years|Baseline up to end of treatment (approximately 3 years)|Baseline up to follow up phase (approximately 3 years)|From the date of initial documentation of a response to date of first documented evidence of progressive disease (or participants relapse who experience CR during the study) or death (approximately up to 3 years)|Day 14 (Cycle 1), Day 1 (Cycle 2) (each cycle is of 21 days)","JNJ.CT@sylogent.com","Study Contact","844-434-4210",{"$cut":{"chars":18246,"head":"Camperdown, Australia, 2050 Peninsula & South Eastern Haematology And Oncology GroupFrankston, Australia, 3199 Royal Hobart HospitalHobart, Australia, 7000 St. George Private Hospital, Oncology Day Care CentreKogarah, Australia, 2217 Peter Maccallum Cancer CentreMelbourne, Australia, 3000 Frankston HospitalMelbourne, Australia, 3199 Fiona Stanley HospitalMurdoch, Australia, 6150|Graz, Austria, 8036 Ordensklinikum Linz Gmbh ElisabethinenLinz, Austria, 4020 Lkh - UniversitÃ¤tsklinikum Der Pmu SalzburgSalzburg, Austria, 5020 Medical University Vienna, MuvVienna, Austria, A-1090|Aalst, Belgium, 9300 Zna MiddelheimAntwerpen, Belgium, 2020 Cliniques Universitaires Saint-LucBrussel, Belgium, 1200 Clinique Notre Dame De GrÃ¢ceCharleroi, Belgium, 6000 Az Maria MiddelaresGent, Belgium, 9000 Uz GentGent, Belgium, 9000 Chc-Cliniques Saint-JosephLiÃ¨ge, Belgium, 4000 Sint-Augustinus AzWilrijk, Belgium, 2610 Chu Dinant Godinne Ucl NamurYvoir, Belgium, 5530|Barretos, Brazil, 14784-400 AssociaÃ§Ã£o MÃ¡rio Penna\\NÃºcleo De Ensino E PesquisasBelo Horizonte, Brazil, 30380-472 Hospital Erasto GaertnerCuritiba, Brazil, 81520-060 ClÃ­nica De Neoplasias Litoral Ltda.Itajai, Brazil, 88301-220 Upco - HcpaPorto Alegre, Brazil, 90035-903 Inca - Instituto Nacional Do CancerRio De Janeiro, Brazil, 20231-050 Fundacao Antonio PrudenteSao Paulo, Brazil, 01509900 Hospital De Base De SÃ£o JosÃ© Do Rio PretoSÃ£o JosÃ© Do Rio Preto, Brazil, 15090-000 Sociedade Beneficiante De Senhoras - Hospital Sirio LibanesSÃ£o Paulo, Brazil, 01308901 Cepho - Faculdade De Medicina Do AbcSÃ£o Paulo, Brazil, 09060-650|Kelowna, British Columbia, Canada, V1Y 5L3 Vancouver Cancer CentreVancouver, British Columbia, Canada, V5Z 4E6|Winnipeg, Manitoba, Canada, R3E 0V9|Thunder Bay, Ontario, Canada, P7B 6V4 Princess Margaret Hospital- UhnToronto, Ontario, Canada, M5G 2M9|Regina, Saskatchewan, Canada, S4T 7T1|Beijing, China, 100021 Peking University First HospitalBeijing, China, 100034 Beijing Friendship HospitalBeijing, China, 100050 Peking University Third HospitalBeijing, China, 100191 Beijing HospitalBeijing, China, 100730 Peking Union Medical College HospitalBeijing, China, 100730 Sichuan Provincial People'S HospitalChengdu, China, 610000 Chongqing Medical UniversityChongqing, China, 400030 Sun Yat-Sen University Cancer CenterGuangzhou, China, 510060 Sun Yat-Sen Memorial Hospital, Sun Yat-Sen UniversityGuangzhou, China, 510120 Guangzhou First Municipal People'S HospitalGuangzhou, China, 510180 Zhejiang Provincial People'S HospitalHangzhou, China, 310000 Sir Run Run Shaw Hospital, Zhejiang UniversityHangzhou, China, 310020 The First Affliated Hospital Of Nanchang UniversityNanchang, China, 330006 Nanjing Drum Tower HospitalNanjing, China, 210008 Jiangsu Cancer HospitalNanjing, China, 210009 Renji Hospital, Shanghai Jiaotong University School Of MedicineShanghai, China, 200127 Huadong Hospital Affiliated To Fudan UniversityShanghai, China, 200400 Shengjing Hospital Of|Shenyang, China, 110004 First Affiliated Hospital, Xi'An Jiaotong UniversityXi'An, China, 710061|Angers, France, 49055 Hopital Jean MinjozBesancon Cedex, France, 25030 Institut BergoniÃ©Bordeaux, France, 33000 Centre Jean PerrinClermont Ferrand, France, 63011 Centre Georges-FranÃ§ois LeclercDijon, France, 21079 Centre Oscar LambretLille, France, 59020 Centre Leon BÃ©rardLyon, France, 69008 Hopital De La TimoneMarseille, France, 13005 Institut Regional Du Cancer De Montpellier Val D'AurelleMontpellier, France, 34298 Centre Antoine LacassagneNice, France, 06189 Institut De CancÃ©rologie Du GardNÃ®mes, France, 30029 Hospital Saint-LouisParis Cedex 10, France, 75475 Hopital Europeen Georges-PompidouParis, France, 75015 Hospices Civils De Lyon HclPierre-BÃ©nite, France, 69495 Chu De PoitiersPoitiers Cedex, France, 86021 Centre Hopitalier Inter-Communal De CornouailleQuimper, France, 29000 Centre Eugene MarquisRennes Cedex, France, 35062 I.C.O. RenÃ© GauducheauSaint Herblain Cedex, France, 44805 Institut De CancÃ©rologie De LoireSaint-Priest-En-Jarez, France, 42271 Hopitaux Universitaires De StrasbourgStrasbourg, France,"}},"Alaska|Arizona|California|Colorado|Florida|Georgia|Idaho|Illinois|Kentucky|Michigan|Nebraska|Nevada|New York|North Carolina|Pennsylvania|South Carolina|Texas|Virginia|Washington","Australia|Austria|Belgium|Brazil|Canada|China|France|Germany|Greece|Hungary|India|Israel|Italy|Japan|Mexico|Netherlands|Portugal|Spain|Turkey|Ukraine|United Kingdom|United States","Chris O'Brien Lifehouse|Lkh-Univ. Klinikum Graz|Olv Ziekenhuis Aalst|Fundacao Pio Xii - Hospital De Cancer De Barretos|British Columbia Bc Cancer Agency - Southern Interior|Manitoba Cancercare Manitoba|Ontario Thunder Bay Regional Health Sciences Centre|Saskatchewan Saskatchewan Cancer Agency (Sca) - Allan Blair Cancer Centre|Cancer Hospital Chinese Academy Of Medical Sciences|Medical University|Institut De CancÃ©rologie De L'Ouest (Ico)|Vivantes Klinikum Am Urban|University General Hospital Of Rio Patras|Semmelweis Egyetem|Manipal Comprehensive Cancer Centre, Manipal Hospital|Rambam Health Care Campus|Azienda Ospedaliera Nazionale Ss. Antonio E Biagio E Cesare Arrigo Alessandria|Chiba Cancer Center|San Peregrino Cancer Center|St. Antonius Ziekenhuis Nieuwegein|Hospital LusÃ­adas|Hosp. Univ. Infanta Cristina|Baskent University Adana Practice And Research Center Kisla Health Campus|Based On Kyiv City Clinical Oncology Center|Chernivtsi Regional Clinical Hospital|University Hospitals Bristol - Bristol Haematology & Oncolog|Alaska Urological Institute Dba Alaska Clinical Research Center|University Of Ua Cancer Center(Uacc)/Dh-Sjhmc|University Of California Irvine Medical Center - Chao Family Comprehensive Cancer Center|Uchealth Anschutz Cancer Pavilion|University Of Miami/Sylvester Cancer Center|Piedmont Cancer Institute|St. Luke's Meridian Medical Center|Rush University|Norton Cancer Institute|University Of Michigan Health System|University Of Nebraska Medical Center|Va Sierra Nevada Health Care System|Montefiore Medical Center|Levine Cancer Institute, Carolinas Healthcare System|Penn State Hershey Cancer Institute|University Of Missouri|The Center For Cancer And Blood Disorders|Inova Dwiight &Martha Schar Cancer Institute|Seattle Cancer Care Alliance",{"$nulls":3},"Janssen Research & Development, LLC Clinical Trials","2019-07-25","2020-05-25T16:35:13.743","2020-05-26T17:10:42.972","NCT03390504"]
["5ecbf3c1feab101b155307cf","NCT03390504","2019-08-22","Johnson & Johnson","JNJ","Recruiting","A Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Participants With Advanced Urothelial Cancer and Selected Fibroblast Growth Factor Receptor (FGFR) Gene Aberrations","Erdafitinib|Fibroblast|Vinflunine|Docetaxel|Pembrolizumab","FGFR Antagonist|Tubulin Inhibitor|Mitosis Inhibitor|Tubulin Inhibitor|PD-1 Inhibitor","Yes","['Fibroblast', 'Vinflunine']","No",null,"Phase 3",4,631,"Anticipated","2018-03-23","2020-11-24","OS","Overall Survival",{"$nulls":3},"The purpose of this study is to evaluate efficacy of erdafitinib versus chemotherapy or pembrolizumab in participants with advanced urothelial cancer harboring selected fibroblast growth factor receptor (FGFR) aberrations who have progressed after 1 or 2 prior treatments, at least 1 of which includes an anti-PD-(L) 1 agent (cohort 1) or 1 prior treatment not containing an anti-PD-(L) 1 agent (cohort 2).","A study of erdafitinib versus standard of care, consisting of chemotherapy (docetaxel or vinflunine) or anti-PD-(L) 1 agent pembrolizumab, in participants with advanced urothelial cancer and selected FGFR aberrations who have progressed on or after 1 or 2 prior treatments, at least 1 of which includes an anti-PD-(L) 1 agent (cohort 1) or 1 prior treatment not containing an anti-PD-(L) 1 agent (cohort 2). It will consist of screening, treatment phase (from randomization until disease progression, intolerable toxicity, withdrawal of consent or decision by investigator to discontinue treatment, post-treatment followup (from end-of-treatment to participants death, withdraws consent, lost to follow-up, or end of study, whichever comes first). Efficacy, pharmacokinetics, biomarkers, patient reported outcomes, medical resource utilization and safety will be assessed.","A Phase 3 Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Subjects With Advanced Urothelial Cancer and Selected FGFR Gene Aberrations","CR108401","Urothelial Cancer","Transitional Cell Carcinoma","Oncology Solid Tumor","Oncology","Experimental","Cohort 1 (Arm 1A): Erdafitinib|Cohort 1 (Arm 1B): Vinflunine or Docetaxel|Cohort 2 (Arm 2A): Erdafitinib|Cohort 2 (Arm 2B): Pembrolizumab","Participants will be screened based on Fibroblast Growth Factor Receptor inhibitor Clinical Trial Assay (FGFRi CTA) to determine molecular eligibility and participants who meet molecular eligibility criteria will be eligible for full study screening. Participants enrolled in the study (treated with prior anti-programmed cell death protein PD-[L] 1 agent) will swallow erdafitinib tablets orally at a starting dose of 8 milligram (mg), once daily for 21 days in a 21-day cycle until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustment are based on phosphate level and observed toxicity (adverse events [AEs]).|Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be eligible for full study screening. Participants enrolled in the study (treated with prior anti-PD-[L] 1 agent) will receive vinflunine 320 milligram per meter square (mg/m^2) as a 20-minute intravenous infusion once every 3 weeks or docetaxel 75 mg/m^2 as a 1 hour intravenous infusion every 3 weeks. Treatment with either agent (choice of investigator) will be administered until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustments are based on observed toxicities.|Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be eligible for full study screening. Participants enrolled in the study (no prior treatment with anti-PD-[L] 1 agent) will swallow erdafitinib tablets orally at a starting dose of 8 mg, once daily for 21 days in a 21-day cycle until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustments are based on phosphate level and observed toxicity (AEs).|Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be eligible for full study screening. Participants enrolled in the study (no prior treatment with anti-PD-[L] 1 agent) will receive pembrolizumab 200 mg as a 30-minute intravenous infusion once every 3 weeks, until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustments are based on observed toxicities.","Drug|Device","Erdafitinib|Fibroblast Growth Factor Receptor inhibitor Clinical Trial Assay (FGFRi CTA)|Vinflunine|Docetaxel|Pembrolizumab","Participants will swallow erdafitinib tablets orally at a starting dose of 8 mg.|FGFRi CTA will be used to determine molecular eligibility.|Participants will receive vinflunine 320 mg/m^2 as a 20-minute intravenous infusion.|Participants will receive docetaxel 75 mg/m^2 as a 1 hour intravenous infusion.|Participants will receive pembrolizumab 200 mg as a 30-minute intravenous infusion.","JNJ-42756493","Cohort 1 (Arm 1A): Erdafitinib|Cohort 1 (Arm 1B): Vinflunine or Docetaxel|Cohort 2 (Arm 2A): Erdafitinib|Cohort 2 (Arm 2B): Pembrolizumab","\n\n * Histologic demonstration of transitional cell carcinoma of the urothelium. Minor components ( less than [<] 50 percent [%] overall) of variant histology such as glandular or squamous differentiation, or evolution to more aggressive phenotypes such as sarcomatoid or micropapillary change are acceptable\n * Metastatic or surgically unresectable urothelial cancer\n * Documented progression of disease, defined as any progression that requires a change in treatment, prior to randomization\n * Cohort 1: Prior treatment with an anti-PD-(L) 1 agent as monotherapy or as combination therapy; no more than 2 prior lines of systemic treatment. Cohort 2: No prior treatment with an anti-PD-(L) 1 agent; only 1 line of prior systemic treatment. Subjects who received neoadjuvant or adjuvant chemotherapy and showed disease progression within 12 months of the last dose are considered to have received systemic therapy in the metastatic setting.\n * A woman of childbearing potential who is sexually active must have a negative pregnancy test (beta human chorionic gonadotropin [beta hCG]) at Screening (urine or serum)\n * Participants must meet appropriate molecular eligibility criteria\n * Eastern Cooperative Oncology Group (ECOG) performance status Grade 0, 1, or 2\n * Adequate bone marrow, liver, and renal function\n\n","\n\n * Treatment with any other investigational agent or participation in another clinical study with therapeutic intent within 30 days prior to randomization\n * Active malignancies (that is, requiring treatment change in the last 24 months). The only allowed exceptions are: urothelial cancer, skin cancer treated within the last 24 months that is considered completely cured, localized prostate cancer with a gleason score of 6 (treated within the last 24 months or untreated and under surveillance) and localized prostate cancer with a gleason score of 3+4 that has been treated more than 6 months prior to full study screening and considered to have a very low risk of recurrence.\n * Symptomatic central nervous system metastases\n * Received prior fibroblast growth factor receptor (FGFR) inhibitor treatment\n * Known allergies, hypersensitivity, or intolerance to erdafitinib or its excipients\n * Current central serous retinopathy (CSR) or retinal pigment epithelial detachment of any grade.\n * History of uncontrolled cardiovascular disease\n * Impaired wound healing capacity defined as skin/decubitus ulcers, chronic leg ulcers, known gastric ulcers, or unhealed incisions",{"$nulls":4},"Actual","2018-01-04","Actual","Anticipated","2021-11-05","Anticipated","2019-08-01","2017-12-20","2018-01-03","2019-08-21","Yes",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No",null,null,"URL: http://pam.sylogent.com/cr/CR108401 [http://pam.sylogent.com/cr/CR108401] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To learn how to participate in this trial please click here.",null,"Yes","Yes",{"$nulls":17},"2017-002932-18|42756493BLC3001","EudraCT Number|Janssen Research & Development, LLC","Overall Survival (OS)","Overall survival is measured from the date of randomization to the date of the participant's death. If the participant is alive or the vital status is unknown, the participant will be censored at the date the participant was last known to be alive.","Date of first randomization to the date of participant's death (approximately up to 3 years)","Progression-free Survival (PFS)|Overall Response Rate (ORR)|Time to Worsening in Symptom Items and Functioning Subscales in Patient-Reported Health Status of the Functional Assessment of Cancer Therapy-Bladder Cancer (FACT-Bl)|Change from Baseline in Patient-Global Impression of Severity (PGIS) Score|Change from Baseline in the Visual Analog Scale (VAS) of the EQ-5D-5L|Change from Baseline in the Utility Scale of the EQ-5D-5L|Duration of Response (DOR)|Number of Participants with Adverse Events (AEs) as a Measure of Safety|Oral Clearance (CL/F) of Erdafitinib|Area Under the Plasma Concentration-Time Curve from Time Zero to Time 't' (AUC[0-t]) of Erdafitinib","PFS is defined as duration in days from date of randomization to disease progression date (assessed per Response Evaluation Criteria in Solid Tumors Version 1.1|ORR is defined as the proportion of participants who achieve CR (CR; disappearance of all target lesions and disappearance of all non-target lesions and normalization of tumor marker level) or partial response (PR; at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters), as assessed per RECIST v1.1 by the investigator.|The FACT-Bl consists of 36 core items, with 5-point Likert response scales, covering 5 primary domains: Physical well-being, social/family well-being, emotional well-being, functional well-being and bladder symptom subscale. The answer scales range from \"Not at all (score=0)\" to \"very much (score=4)\" to assess the meaningful significant symptom deterioration.|The PGIS is a single question regarding the participant report of disease severity. Participants will be asked that ''considering all aspects of your bladder cancer symptoms right now, would you say your bladder cancer symptoms are none, mild, moderate, severe, or very severe?\" The PGIS is an anchor question that will be used to establish the magnitude of meaningful change in this study by assessing disease severity.|European Quality of Life 5 Dimensions (EQ-5D) visual analog scale (VAS) is a 20 centimeter (cm) vertical VAS with scores ranging from 0 (worst imaginable health) to 100 (perfect health). A higher score indicates an improvement in health in the Health Status Index.|The EuroQol-5 is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating \"full health\" and 0 representing dead.|DOR for responders is defined as duration in days from the date of initial documentation of a response to the date of first documented evidence of progressive disease (PD) or relapse for participants who experience CR (CR; disappearance of all target lesions and disappearance of all non-target lesions and normalization of tumor marker level) during the study or death.|An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.|CL/F is the oral clearance; that is clearance based on oral bioavailability of erdafitinib.|AUC(0-t) is the area under the plasma concentration-time curve from time zero to any time 't' of erdafitinib.","RECIST v1.1 by investigator) or relapse from CR or death, whichever is reported first. RECIST 1.1, progressive disease is defined as a 20 percent (%) increase in the sum of diameters of all target lesions and a minimum absolute increase of 5 millimeter (mm) in the sum. CR is defined as disappearance of all target lesions, non-target lesions and normalization of tumor marker level.|Approximately up to 3 years|Baseline up to end of treatment (approximately 3 years)|Baseline up to follow up phase (approximately 3 years)|From the date of initial documentation of a response to date of first documented evidence of progressive disease (or participants relapse who experience CR during the study) or death (approximately up to 3 years)|Day 14 (Cycle 1), Day 1 (Cycle 2) (each cycle is of 21 days)","JNJ.CT@sylogent.com","Study Contact","844-434-4210",{"$cut":{"chars":19051,"head":"Camperdown, Australia, 2050 Peninsula & South Eastern Haematology And Oncology GroupFrankston, Australia, 3199 Royal Hobart HospitalHobart, Australia, 7000 St. George Private Hospital, Oncology Day Care CentreKogarah, Australia, 2217 Peter Maccallum Cancer CentreMelbourne, Australia, 3000 Frankston HospitalMelbourne, Australia, 3199 Fiona Stanley HospitalMurdoch, Australia, 6150|Graz, Austria, 8036 Ordensklinikum Linz Gmbh ElisabethinenLinz, Austria, 4020 Lkh - UniversitÃ¤tsklinikum Der Pmu SalzburgSalzburg, Austria, 5020 Medical University Vienna, MuvVienna, Austria, A-1090|Aalst, Belgium, 9300 Zna MiddelheimAntwerpen, Belgium, 2020 Cliniques Universitaires Saint-LucBrussel, Belgium, 1200 Clinique Notre Dame De GrÃ¢ceCharleroi, Belgium, 6000 Az Maria MiddelaresGent, Belgium, 9000 Uz GentGent, Belgium, 9000 Chc-Cliniques Saint-JosephLiÃ¨ge, Belgium, 4000 Sint-Augustinus AzWilrijk, Belgium, 2610 Chu Dinant Godinne Ucl NamurYvoir, Belgium, 5530|Barretos, Brazil, 14784-400 AssociaÃ§Ã£o MÃ¡rio Penna\\NÃºcleo De Ensino E PesquisasBelo Horizonte, Brazil, 30380-472 Hospital Erasto GaertnerCuritiba, Brazil, 81520-060 Hospital AraÃºjo Jorge Da AssociaÃ§Ã£o De Combate Ao CÃ¢ncer Em GoiÃ¡sGoiÃ¢nia, Brazil, 74605-070 ClÃ­nica De Neoplasias Litoral Ltda.Itajai, Brazil, 88301-220 Upco - HcpaPorto Alegre, Brazil, 90035-903 Inca - Instituto Nacional Do CancerRio De Janeiro, Brazil, 20231-050 OncoclÃ­nicasRio De Janeiro, Brazil, 22250-905 Fundacao Antonio PrudenteSao Paulo, Brazil, 01509900 Ibcc - Instituto Brasileiro De Controle Do CancerSao Paulo, Brazil Hospital De Base De SÃ£o JosÃ© Do Rio PretoSÃ£o JosÃ© Do Rio Preto, Brazil, 15090-000 Sociedade Beneficiante De Senhoras - Hospital Sirio LibanesSÃ£o Paulo, Brazil, 01308901 Instituto D'Or De Pesquisa E Ensino (Idor)SÃ£o Paulo, Brazil, 04502-001 Hospital Israelita Albert EinsteinSÃ£o Paulo, Brazil, 05651-900 Cepho - Faculdade De Medicina Do AbcSÃ£o Paulo, Brazil, 09060-650|Kelowna, British Columbia, Canada, V1Y 5L3 Vancouver Cancer CentreVancouver, British Columbia, Canada, V5Z 4E6|Winnipeg, Manitoba, Canada, R3E 0V9|Thunder Bay, Ontario, Canada, P7B 6V4 Princess Margaret Hospital- UhnToronto, Ontario, Canada, M5G 2M9|Regina, Saskatchewan, Canada, S4T 7T1|Beijing, China, 100021 Peking University First HospitalBeijing, China, 100034 Beijing Friendship HospitalBeijing, China, 100050 Peking University Third HospitalBeijing, China, 100191 Beijing HospitalBeijing, China, 100730 Peking Union Medical College HospitalBeijing, China, 100730 Sichuan Provincial People'S HospitalChengdu, China, 610000 Chongqing Medical UniversityChongqing, China, 400030 Sun Yat-Sen University Cancer CenterGuangzhou, China, 510060 Sun Yat-Sen Memorial Hospital, Sun Yat-Sen UniversityGuangzhou, China, 510120 Guangzhou First Municipal People'S HospitalGuangzhou, China, 510180 Zhejiang Provincial People'S HospitalHangzhou, China, 310014 Sir Run Run Shaw Hospital, Zhejiang UniversityHangzhou, China, 310020 The First Affliated Hospital Of Nanchang UniversityNanchang, China, 330006 Nanjing Drum Tower HospitalNanjing, China, 210008 Jiangsu Cancer HospitalNanjing, China, 210009 Renji Hospital, Shanghai Jiaotong University School Of MedicineShanghai, China, 200127 Huadong Hospital Affiliated To Fudan UniversityShanghai, China, 200400 Shengjing Hospital Of|Shenyang, China, 110004 First Affiliated Hospital, Xi'An Jiaotong UniversityXi'An, China, 710061|Angers, France, 49055 Hopital Jean MinjozBesancon Cedex, France, 25030 Institut BergoniÃ©Bordeaux, France, 33000 Centre Jean PerrinClermont Ferrand, France, 63011 Centre Georges-FranÃ§ois LeclercDijon, France, 21079 Centre Oscar LambretLille, France, 59020 Centre Leon BÃ©rardLyon, France, 69008 Hopital De La TimoneMarseille, France, 13005 Institut Regional Du Cancer De Montpellier Val D'AurelleMontpellier, France, 34298 Centre Antoine LacassagneNice, France, 06189 Institut De CancÃ©rologie Du GardNÃ®mes, France, 30029 Hospital Saint-LouisParis Cedex 10, France, 75475 Hopital Europeen Georges-PompidouParis, France, 75015 Hospices Civils De Lyon HclPierre-BÃ©nite, France, 69495 Ch"}},"Alaska|Arizona|California|Colorado|Florida|Georgia|Idaho|Illinois|Kentucky|Michigan|Nebraska|Nevada|New York|North Carolina|Pennsylvania|South Carolina|Texas|Virginia|Washington","Australia|Austria|Belgium|Brazil|Canada|China|France|Germany|Greece|Hungary|India|Israel|Italy|Japan|Mexico|Netherlands|Portugal|Spain|Turkey|Ukraine|United Kingdom|United States","Chris O'Brien Lifehouse|Lkh-Univ. Klinikum Graz|Olv Ziekenhuis Aalst|Fundacao Pio Xii - Hospital De Cancer De Barretos|British Columbia Bc Cancer Agency - Southern Interior|Manitoba Cancercare Manitoba|Ontario Thunder Bay Regional Health Sciences Centre|Saskatchewan Saskatchewan Cancer Agency (Sca) - Allan Blair Cancer Centre|Cancer Hospital Chinese Academy Of Medical Sciences|Medical University|Institut De CancÃ©rologie De L'Ouest (Ico)|Vivantes Klinikum Am Urban|University General Hospital Of Rio Patras|Semmelweis Egyetem|Manipal Comprehensive Cancer Centre, Manipal Hospital|Rambam Health Care Campus|Azienda Ospedaliera Nazionale Ss. Antonio E Biagio E Cesare Arrigo Alessandria|Chiba Cancer Center|San Peregrino Cancer Center|St. Antonius Ziekenhuis Nieuwegein|Hospital LusÃ­adas|Hosp. Univ. Infanta Cristina|Baskent University Adana Practice And Research Center Kisla Health Campus|Based On Kyiv City Clinical Oncology Center|Chernivtsi Regional Clinical Hospital|University Hospitals Bristol - Bristol Haematology & Oncolog|Alaska Urological Institute Dba Alaska Clinical Research Center|University Of Ua Cancer Center(Uacc)/Dh-Sjhmc|University Of California Irvine Medical Center - Chao Family Comprehensive Cancer Center|Uchealth Anschutz Cancer Pavilion|University Of Miami/Sylvester Cancer Center|Piedmont Cancer Institute|St. Luke's Meridian Medical Center|Rush University|Norton Cancer Institute|University Of Michigan Health System|University Of Nebraska Medical Center|Va Sierra Nevada Health Care System|Montefiore Medical Center|Levine Cancer Institute, Carolinas Healthcare System|Penn State Hershey Cancer Institute|University Of Missouri|The Center For Cancer And Blood Disorders|Inova Dwiight &Martha Schar Cancer Institute|Seattle Cancer Care Alliance",{"$nulls":3},"Janssen Research & Development, LLC Clinical Trials","2019-08-21","2020-05-25T16:35:13.854","2020-05-26T17:10:42.972","NCT03390504"]
["5ecbf3c1e2561b1b11905c9b","NCT03390504","2019-09-19","Johnson & Johnson","JNJ","Recruiting","A Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Participants With Advanced Urothelial Cancer and Selected Fibroblast Growth Factor Receptor (FGFR) Gene Aberrations","Erdafitinib|Fibroblast|Vinflunine|Docetaxel|Pembrolizumab","FGFR Antagonist|Tubulin Inhibitor|Mitosis Inhibitor|Tubulin Inhibitor|PD-1 Inhibitor","Yes","['Fibroblast', 'Vinflunine']","No",null,"Phase 3",4,631,"Anticipated","2018-03-23","2020-11-24","OS","Overall Survival",{"$nulls":3},"The purpose of this study is to evaluate efficacy of erdafitinib versus chemotherapy or pembrolizumab in participants with advanced urothelial cancer harboring selected fibroblast growth factor receptor (FGFR) aberrations who have progressed after 1 or 2 prior treatments, at least 1 of which includes an anti-PD-(L) 1 agent (cohort 1) or 1 prior treatment not containing an anti-PD-(L) 1 agent (cohort 2).","A study of erdafitinib versus standard of care, consisting of chemotherapy (docetaxel or vinflunine) or anti-PD-(L) 1 agent pembrolizumab, in participants with advanced urothelial cancer and selected FGFR aberrations who have progressed on or after 1 or 2 prior treatments, at least 1 of which includes an anti-PD-(L) 1 agent (cohort 1) or 1 prior treatment not containing an anti-PD-(L) 1 agent (cohort 2). It will consist of screening, treatment phase (from randomization until disease progression, intolerable toxicity, withdrawal of consent or decision by investigator to discontinue treatment, post-treatment followup (from end-of-treatment to participants death, withdraws consent, lost to follow-up, or end of study, whichever comes first). Efficacy, pharmacokinetics, biomarkers, patient reported outcomes, medical resource utilization and safety will be assessed.","A Phase 3 Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Subjects With Advanced Urothelial Cancer and Selected FGFR Gene Aberrations","CR108401","Urothelial Cancer","Transitional Cell Carcinoma","Oncology Solid Tumor","Oncology","Experimental","Cohort 1 (Arm 1A): Erdafitinib|Cohort 1 (Arm 1B): Vinflunine or Docetaxel|Cohort 2 (Arm 2A): Erdafitinib|Cohort 2 (Arm 2B): Pembrolizumab","Participants will be screened based on Fibroblast Growth Factor Receptor inhibitor Clinical Trial Assay (FGFRi CTA) to determine molecular eligibility and participants who meet molecular eligibility criteria will be eligible for full study screening. Participants enrolled in the study (treated with prior anti-programmed cell death protein PD-[L] 1 agent) will swallow erdafitinib tablets orally at a starting dose of 8 milligram (mg), once daily for 21 days in a 21-day cycle until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustment are based on phosphate level and observed toxicity (adverse events [AEs]).|Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be eligible for full study screening. Participants enrolled in the study (treated with prior anti-PD-[L] 1 agent) will receive vinflunine 320 milligram per meter square (mg/m^2) as a 20-minute intravenous infusion once every 3 weeks or docetaxel 75 mg/m^2 as a 1 hour intravenous infusion every 3 weeks. Treatment with either agent (choice of investigator) will be administered until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustments are based on observed toxicities.|Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be eligible for full study screening. Participants enrolled in the study (no prior treatment with anti-PD-[L] 1 agent) will swallow erdafitinib tablets orally at a starting dose of 8 mg, once daily for 21 days in a 21-day cycle until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustments are based on phosphate level and observed toxicity (AEs).|Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be eligible for full study screening. Participants enrolled in the study (no prior treatment with anti-PD-[L] 1 agent) will receive pembrolizumab 200 mg as a 30-minute intravenous infusion once every 3 weeks, until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustments are based on observed toxicities.","Drug|Device","Erdafitinib|Fibroblast Growth Factor Receptor inhibitor Clinical Trial Assay (FGFRi CTA)|Vinflunine|Docetaxel|Pembrolizumab","Participants will swallow erdafitinib tablets orally at a starting dose of 8 mg.|FGFRi CTA will be used to determine molecular eligibility.|Participants will receive vinflunine 320 mg/m^2 as a 20-minute intravenous infusion.|Participants will receive docetaxel 75 mg/m^2 as a 1 hour intravenous infusion.|Participants will receive pembrolizumab 200 mg as a 30-minute intravenous infusion.","JNJ-42756493","Cohort 1 (Arm 1A): Erdafitinib|Cohort 1 (Arm 1B): Vinflunine or Docetaxel|Cohort 2 (Arm 2A): Erdafitinib|Cohort 2 (Arm 2B): Pembrolizumab","\n\n * Histologic demonstration of transitional cell carcinoma of the urothelium. Minor components ( less than [<] 50 percent [%] overall) of variant histology such as glandular or squamous differentiation, or evolution to more aggressive phenotypes such as sarcomatoid or micropapillary change are acceptable\n * Metastatic or surgically unresectable urothelial cancer\n * Documented progression of disease, defined as any progression that requires a change in treatment, prior to randomization\n * Cohort 1: Prior treatment with an anti-PD-(L) 1 agent as monotherapy or as combination therapy; no more than 2 prior lines of systemic treatment. Cohort 2: No prior treatment with an anti-PD-(L) 1 agent; only 1 line of prior systemic treatment. Subjects who received neoadjuvant or adjuvant chemotherapy and showed disease progression within 12 months of the last dose are considered to have received systemic therapy in the metastatic setting.\n * A woman of childbearing potential who is sexually active must have a negative pregnancy test (beta human chorionic gonadotropin [beta hCG]) at Screening (urine or serum)\n * Participants must meet appropriate molecular eligibility criteria\n * Eastern Cooperative Oncology Group (ECOG) performance status Grade 0, 1, or 2\n * Adequate bone marrow, liver, and renal function\n\n","\n\n * Treatment with any other investigational agent or participation in another clinical study with therapeutic intent within 30 days prior to randomization\n * Active malignancies (that is, requiring treatment change in the last 24 months). The only allowed exceptions are: urothelial cancer, skin cancer treated within the last 24 months that is considered completely cured, localized prostate cancer with a gleason score of 6 (treated within the last 24 months or untreated and under surveillance) and localized prostate cancer with a gleason score of 3+4 that has been treated more than 6 months prior to full study screening and considered to have a very low risk of recurrence.\n * Symptomatic central nervous system metastases\n * Received prior fibroblast growth factor receptor (FGFR) inhibitor treatment\n * Known allergies, hypersensitivity, or intolerance to erdafitinib or its excipients\n * Current central serous retinopathy (CSR) or retinal pigment epithelial detachment of any grade.\n * History of uncontrolled cardiovascular disease\n * Impaired wound healing capacity defined as skin/decubitus ulcers, chronic leg ulcers, known gastric ulcers, or unhealed incisions",{"$nulls":4},"Actual","2018-01-04","Actual","Anticipated","2021-11-05","Anticipated","2019-09-01","2017-12-20","2018-01-03","2019-09-18","Yes",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No",null,null,"URL: http://pam.sylogent.com/cr/CR108401 [http://pam.sylogent.com/cr/CR108401] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To learn how to participate in this trial please click here.",null,"Yes","Yes",{"$nulls":17},"2017-002932-18|42756493BLC3001","EudraCT Number|Janssen Research & Development, LLC","Overall Survival (OS)","Overall survival is measured from the date of randomization to the date of the participant's death. If the participant is alive or the vital status is unknown, the participant will be censored at the date the participant was last known to be alive.","Date of first randomization to the date of participant's death (approximately up to 3 years)","Progression-free Survival (PFS)|Overall Response Rate (ORR)|Time to Worsening in Symptom Items and Functioning Subscales in Patient-Reported Health Status of the Functional Assessment of Cancer Therapy-Bladder Cancer (FACT-Bl)|Change from Baseline in Patient-Global Impression of Severity (PGIS) Score|Change from Baseline in the Visual Analog Scale (VAS) of the EQ-5D-5L|Change from Baseline in the Utility Scale of the EQ-5D-5L|Duration of Response (DOR)|Number of Participants with Adverse Events (AEs) as a Measure of Safety|Oral Clearance (CL/F) of Erdafitinib|Area Under the Plasma Concentration-Time Curve from Time Zero to Time 't' (AUC[0-t]) of Erdafitinib","PFS is defined as duration in days from date of randomization to disease progression date (assessed per Response Evaluation Criteria in Solid Tumors Version 1.1|ORR is defined as the proportion of participants who achieve CR (CR; disappearance of all target lesions and disappearance of all non-target lesions and normalization of tumor marker level) or partial response (PR; at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters), as assessed per RECIST v1.1 by the investigator.|The FACT-Bl consists of 36 core items, with 5-point Likert response scales, covering 5 primary domains: Physical well-being, social/family well-being, emotional well-being, functional well-being and bladder symptom subscale. The answer scales range from \"Not at all (score=0)\" to \"very much (score=4)\" to assess the meaningful significant symptom deterioration.|The PGIS is a single question regarding the participant report of disease severity. Participants will be asked that ''considering all aspects of your bladder cancer symptoms right now, would you say your bladder cancer symptoms are none, mild, moderate, severe, or very severe?\" The PGIS is an anchor question that will be used to establish the magnitude of meaningful change in this study by assessing disease severity.|European Quality of Life 5 Dimensions (EQ-5D) visual analog scale (VAS) is a 20 centimeter (cm) vertical VAS with scores ranging from 0 (worst imaginable health) to 100 (perfect health). A higher score indicates an improvement in health in the Health Status Index.|The EuroQol-5 is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating \"full health\" and 0 representing dead.|DOR for responders is defined as duration in days from the date of initial documentation of a response to the date of first documented evidence of progressive disease (PD) or relapse for participants who experience CR (CR; disappearance of all target lesions and disappearance of all non-target lesions and normalization of tumor marker level) during the study or death.|An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.|CL/F is the oral clearance; that is clearance based on oral bioavailability of erdafitinib.|AUC(0-t) is the area under the plasma concentration-time curve from time zero to any time 't' of erdafitinib.","RECIST v1.1 by investigator) or relapse from CR or death, whichever is reported first. RECIST 1.1, progressive disease is defined as a 20 percent (%) increase in the sum of diameters of all target lesions and a minimum absolute increase of 5 millimeter (mm) in the sum. CR is defined as disappearance of all target lesions, non-target lesions and normalization of tumor marker level.|Approximately up to 3 years|Baseline up to end of treatment (approximately 3 years)|Baseline up to follow up phase (approximately 3 years)|From the date of initial documentation of a response to date of first documented evidence of progressive disease (or participants relapse who experience CR during the study) or death (approximately up to 3 years)|Day 14 (Cycle 1), Day 1 (Cycle 2) (each cycle is of 21 days)","JNJ.CT@sylogent.com","Study Contact","844-434-4210",{"$cut":{"chars":18917,"head":"Camperdown, Australia, 2050 Peninsula & South Eastern Haematology And Oncology GroupFrankston, Australia, 3199 Royal Hobart HospitalHobart, Australia, 7000 St. George Private Hospital, Oncology Day Care CentreKogarah, Australia, 2217 Peter Maccallum Cancer CentreMelbourne, Australia, 3000 Frankston HospitalMelbourne, Australia, 3199 Fiona Stanley HospitalMurdoch, Australia, 6150|Graz, Austria, 8036 Ordensklinikum Linz Gmbh ElisabethinenLinz, Austria, 4020 Lkh - UniversitÃ¤tsklinikum Der Pmu SalzburgSalzburg, Austria, 5020 Medical University Vienna, MuvVienna, Austria, A-1090|Aalst, Belgium, 9300 Zna MiddelheimAntwerpen, Belgium, 2020 Cliniques Universitaires Saint-LucBrussel, Belgium, 1200 Clinique Notre Dame De GrÃ¢ceCharleroi, Belgium, 6000 Az Maria MiddelaresGent, Belgium, 9000 Uz GentGent, Belgium, 9000 Chc-Cliniques Saint-JosephLiÃ¨ge, Belgium, 4000 Sint-Augustinus AzWilrijk, Belgium, 2610 Chu Dinant Godinne Ucl NamurYvoir, Belgium, 5530|Barretos, Brazil, 14784-400 AssociaÃ§Ã£o MÃ¡rio Penna\\NÃºcleo De Ensino E PesquisasBelo Horizonte, Brazil, 30380-472 Hospital Erasto GaertnerCuritiba, Brazil, 81520-060 Hospital AraÃºjo Jorge Da AssociaÃ§Ã£o De Combate Ao CÃ¢ncer Em GoiÃ¡sGoiÃ¢nia, Brazil, 74605-070 ClÃ­nica De Neoplasias Litoral Ltda.Itajai, Brazil, 88301-220 Upco - HcpaPorto Alegre, Brazil, 90035-903 Inca - Instituto Nacional Do CancerRio De Janeiro, Brazil, 20231-050 OncoclÃ­nicasRio De Janeiro, Brazil, 22250-905 Fundacao Antonio PrudenteSao Paulo, Brazil, 01509900 Ibcc - Instituto Brasileiro De Controle Do CancerSao Paulo, Brazil Hospital De Base De SÃ£o JosÃ© Do Rio PretoSÃ£o JosÃ© Do Rio Preto, Brazil, 15090-000 Sociedade Beneficiante De Senhoras - Hospital Sirio LibanesSÃ£o Paulo, Brazil, 01308901 Instituto D'Or De Pesquisa E Ensino (Idor)SÃ£o Paulo, Brazil, 04502-001 Hospital Israelita Albert EinsteinSÃ£o Paulo, Brazil, 05651-900 Cepho - Faculdade De Medicina Do AbcSÃ£o Paulo, Brazil, 09060-650|Kelowna, British Columbia, Canada, V1Y 5L3 Vancouver Cancer CentreVancouver, British Columbia, Canada, V5Z 4E6|Winnipeg, Manitoba, Canada, R3E 0V9|Thunder Bay, Ontario, Canada, P7B 6V4 Princess Margaret Hospital- UhnToronto, Ontario, Canada, M5G 2M9|Regina, Saskatchewan, Canada, S4T 7T1|Beijing, China, 100021 Peking University First HospitalBeijing, China, 100034 Beijing Friendship HospitalBeijing, China, 100050 Peking University Third HospitalBeijing, China, 100191 Beijing HospitalBeijing, China, 100730 Peking Union Medical College HospitalBeijing, China, 100730 Sichuan Provincial People'S HospitalChengdu, China, 610000 Chongqing Medical UniversityChongqing, China, 400030 Sun Yat-Sen University Cancer CenterGuangzhou, China, 510060 Sun Yat-Sen Memorial Hospital, Sun Yat-Sen UniversityGuangzhou, China, 510120 Guangzhou First Municipal People'S HospitalGuangzhou, China, 510180 Zhejiang Provincial People'S HospitalHangzhou, China, 310014 Sir Run Run Shaw Hospital, Zhejiang UniversityHangzhou, China, 310020 The First Affliated Hospital Of Nanchang UniversityNanchang, China, 330006 Nanjing Drum Tower HospitalNanjing, China, 210008 Jiangsu Cancer HospitalNanjing, China, 210009 Renji Hospital, Shanghai Jiaotong University School Of MedicineShanghai, China, 200127 Huadong Hospital Affiliated To Fudan UniversityShanghai, China, 200400 Shengjing Hospital Of|Shenyang, China, 110004 First Affiliated Hospital, Xi'An Jiaotong UniversityXi'An, China, 710061|Angers, France, 49055 Hopital Jean MinjozBesancon Cedex, France, 25030 Institut BergoniÃ©Bordeaux, France, 33000 Centre Jean PerrinClermont Ferrand, France, 63011 Centre Georges-FranÃ§ois LeclercDijon, France, 21079 Centre Oscar LambretLille, France, 59020 Centre Leon BÃ©rardLyon, France, 69008 Hopital De La TimoneMarseille, France, 13005 Institut Regional Du Cancer De Montpellier Val D'AurelleMontpellier, France, 34298 Centre Antoine LacassagneNice, France, 06189 Institut De CancÃ©rologie Du GardNÃ®mes, France, 30029 Hospital Saint-LouisParis Cedex 10, France, 75475 Hopital Europeen Georges-PompidouParis, France, 75015 Hospices Civils De Lyon HclPierre-BÃ©nite, France, 69495 Ch"}},"Alaska|Arizona|California|Colorado|Florida|Georgia|Idaho|Illinois|Kentucky|Michigan|Nebraska|Nevada|New York|North Carolina|Pennsylvania|South Carolina|Texas|Virginia|Washington","Australia|Austria|Belgium|Brazil|Canada|China|France|Germany|Greece|Hungary|India|Israel|Italy|Japan|Mexico|Netherlands|Portugal|Spain|Turkey|Ukraine|United Kingdom|United States","Chris O'Brien Lifehouse|Lkh-Univ. Klinikum Graz|Olv Ziekenhuis Aalst|Fundacao Pio Xii - Hospital De Cancer De Barretos|British Columbia Bc Cancer Agency - Southern Interior|Manitoba Cancercare Manitoba|Ontario Thunder Bay Regional Health Sciences Centre|Saskatchewan Saskatchewan Cancer Agency (Sca) - Allan Blair Cancer Centre|Cancer Hospital Chinese Academy Of Medical Sciences|Medical University|Institut De CancÃ©rologie De L'Ouest (Ico)|Vivantes Klinikum Am Urban|University General Hospital Of Rio Patras|Semmelweis Egyetem|Manipal Comprehensive Cancer Centre, Manipal Hospital|Rambam Health Care Campus|Azienda Ospedaliera Nazionale Ss. Antonio E Biagio E Cesare Arrigo Alessandria|Chiba Cancer Center|San Peregrino Cancer Center|St. Antonius Ziekenhuis Nieuwegein|Hospital LusÃ­adas|Hosp. Univ. Infanta Cristina|Baskent University Adana Practice And Research Center Kisla Health Campus|Based On Kyiv City Clinical Oncology Center|Chernivtsi Regional Clinical Hospital|University Hospitals Bristol - Bristol Haematology & Oncolog|Alaska Urological Institute Dba Alaska Clinical Research Center|University Of Ua Cancer Center(Uacc)/Dh-Sjhmc|University Of California Irvine Medical Center - Chao Family Comprehensive Cancer Center|Uchealth Anschutz Cancer Pavilion|University Of Miami/Sylvester Cancer Center|Piedmont Cancer Institute|St. Luke's Meridian Medical Center|Rush University|Norton Cancer Institute|University Of Michigan Health System|University Of Nebraska Medical Center|Va Sierra Nevada Health Care System|Montefiore Medical Center|Levine Cancer Institute, Carolinas Healthcare System|Penn State Hershey Cancer Institute|University Of Missouri|The Center For Cancer And Blood Disorders|Inova Dwiight &Martha Schar Cancer Institute|Va Puget Sound Healthcare System",{"$nulls":3},"Janssen Research & Development, LLC Clinical Trials","2019-09-18","2020-05-25T16:35:13.907","2020-05-26T17:10:42.972","NCT03390504"]
["5ecbf3c2fe30261b1a0481a0","NCT03390504","2019-10-17","Johnson & Johnson","JNJ","Recruiting","A Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Participants With Advanced Urothelial Cancer and Selected Fibroblast Growth Factor Receptor (FGFR) Gene Aberrations","Erdafitinib|Fibroblast|Vinflunine|Docetaxel|Pembrolizumab","FGFR Antagonist|Tubulin Inhibitor|Mitosis Inhibitor|Tubulin Inhibitor|PD-1 Inhibitor","Yes","['Fibroblast', 'Vinflunine']","No",null,"Phase 3",4,631,"Anticipated","2018-03-23","2020-11-24","OS","Overall Survival",{"$nulls":3},"The purpose of this study is to evaluate efficacy of erdafitinib versus chemotherapy or pembrolizumab in participants with advanced urothelial cancer harboring selected fibroblast growth factor receptor (FGFR) aberrations who have progressed after 1 or 2 prior treatments, at least 1 of which includes an anti-PD-(L) 1 agent (cohort 1) or 1 prior treatment not containing an anti-PD-(L) 1 agent (cohort 2).","A study of erdafitinib versus standard of care, consisting of chemotherapy (docetaxel or vinflunine) or anti-PD-(L) 1 agent pembrolizumab, in participants with advanced urothelial cancer and selected FGFR aberrations who have progressed on or after 1 or 2 prior treatments, at least 1 of which includes an anti-PD-(L) 1 agent (cohort 1) or 1 prior treatment not containing an anti-PD-(L) 1 agent (cohort 2). It will consist of screening, treatment phase (from randomization until disease progression, intolerable toxicity, withdrawal of consent or decision by investigator to discontinue treatment, post-treatment followup (from end-of-treatment to participants death, withdraws consent, lost to follow-up, or end of study, whichever comes first). Efficacy, pharmacokinetics, biomarkers, patient reported outcomes, medical resource utilization and safety will be assessed.","A Phase 3 Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Subjects With Advanced Urothelial Cancer and Selected FGFR Gene Aberrations","CR108401","Urothelial Cancer","Transitional Cell Carcinoma","Oncology Solid Tumor","Oncology","Experimental","Cohort 1 (Arm 1A): Erdafitinib|Cohort 1 (Arm 1B): Vinflunine or Docetaxel|Cohort 2 (Arm 2A): Erdafitinib|Cohort 2 (Arm 2B): Pembrolizumab","Participants will be screened based on Fibroblast Growth Factor Receptor inhibitor Clinical Trial Assay (FGFRi CTA) to determine molecular eligibility and participants who meet molecular eligibility criteria will be eligible for full study screening. Participants enrolled in the study (treated with prior anti-programmed cell death protein PD-[L] 1 agent) will swallow erdafitinib tablets orally at a starting dose of 8 milligram (mg), once daily for 21 days in a 21-day cycle until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustment are based on phosphate level and observed toxicity (adverse events [AEs]).|Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be eligible for full study screening. Participants enrolled in the study (treated with prior anti-PD-[L] 1 agent) will receive vinflunine 320 milligram per meter square (mg/m^2) as a 20-minute intravenous infusion once every 3 weeks or docetaxel 75 mg/m^2 as a 1 hour intravenous infusion every 3 weeks. Treatment with either agent (choice of investigator) will be administered until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustments are based on observed toxicities.|Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be eligible for full study screening. Participants enrolled in the study (no prior treatment with anti-PD-[L] 1 agent) will swallow erdafitinib tablets orally at a starting dose of 8 mg, once daily for 21 days in a 21-day cycle until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustments are based on phosphate level and observed toxicity (AEs).|Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be eligible for full study screening. Participants enrolled in the study (no prior treatment with anti-PD-[L] 1 agent) will receive pembrolizumab 200 mg as a 30-minute intravenous infusion once every 3 weeks, until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustments are based on observed toxicities.","Drug|Device","Erdafitinib|Fibroblast Growth Factor Receptor inhibitor Clinical Trial Assay (FGFRi CTA)|Vinflunine|Docetaxel|Pembrolizumab","Participants will swallow erdafitinib tablets orally at a starting dose of 8 mg.|FGFRi CTA will be used to determine molecular eligibility.|Participants will receive vinflunine 320 mg/m^2 as a 20-minute intravenous infusion.|Participants will receive docetaxel 75 mg/m^2 as a 1 hour intravenous infusion.|Participants will receive pembrolizumab 200 mg as a 30-minute intravenous infusion.","JNJ-42756493","Cohort 1 (Arm 1A): Erdafitinib|Cohort 1 (Arm 1B): Vinflunine or Docetaxel|Cohort 2 (Arm 2A): Erdafitinib|Cohort 2 (Arm 2B): Pembrolizumab","\n\n * Histologic demonstration of transitional cell carcinoma of the urothelium. Minor components ( less than [<] 50 percent [%] overall) of variant histology such as glandular or squamous differentiation, or evolution to more aggressive phenotypes such as sarcomatoid or micropapillary change are acceptable\n * Metastatic or surgically unresectable urothelial cancer\n * Documented progression of disease, defined as any progression that requires a change in treatment, prior to randomization\n * Cohort 1: Prior treatment with an anti-PD-(L) 1 agent as monotherapy or as combination therapy; no more than 2 prior lines of systemic treatment. Cohort 2: No prior treatment with an anti-PD-(L) 1 agent; only 1 line of prior systemic treatment. Subjects who received neoadjuvant or adjuvant chemotherapy and showed disease progression within 12 months of the last dose are considered to have received systemic therapy in the metastatic setting.\n * A woman of childbearing potential who is sexually active must have a negative pregnancy test (beta human chorionic gonadotropin [beta hCG]) at Screening (urine or serum)\n * Participants must meet appropriate molecular eligibility criteria\n * Eastern Cooperative Oncology Group (ECOG) performance status Grade 0, 1, or 2\n * Adequate bone marrow, liver, and renal function\n\n","\n\n * Treatment with any other investigational agent or participation in another clinical study with therapeutic intent within 30 days prior to randomization\n * Active malignancies (that is, requiring treatment change in the last 24 months). The only allowed exceptions are: urothelial cancer, skin cancer treated within the last 24 months that is considered completely cured, localized prostate cancer with a gleason score of 6 (treated within the last 24 months or untreated and under surveillance) and localized prostate cancer with a gleason score of 3+4 that has been treated more than 6 months prior to full study screening and considered to have a very low risk of recurrence.\n * Symptomatic central nervous system metastases\n * Received prior fibroblast growth factor receptor (FGFR) inhibitor treatment\n * Known allergies, hypersensitivity, or intolerance to erdafitinib or its excipients\n * Current central serous retinopathy (CSR) or retinal pigment epithelial detachment of any grade.\n * History of uncontrolled cardiovascular disease\n * Impaired wound healing capacity defined as skin/decubitus ulcers, chronic leg ulcers, known gastric ulcers, or unhealed incisions",{"$nulls":4},"Actual","2018-01-04","Actual","Anticipated","2021-11-05","Anticipated","2019-10-01","2017-12-20","2018-01-03","2019-10-16","Yes",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No",null,null,"URL: http://pam.sylogent.com/cr/CR108401 [http://pam.sylogent.com/cr/CR108401] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To learn how to participate in this trial please click here.",null,"Yes","Yes",{"$nulls":17},"2017-002932-18|42756493BLC3001","EudraCT Number|Janssen Research & Development, LLC","Overall Survival (OS)","Overall survival is measured from the date of randomization to the date of the participant's death. If the participant is alive or the vital status is unknown, the participant will be censored at the date the participant was last known to be alive.","Date of first randomization to the date of participant's death (approximately up to 3 years)","Progression-free Survival (PFS)|Overall Response Rate (ORR)|Time to Worsening in Symptom Items and Functioning Subscales in Patient-Reported Health Status of the Functional Assessment of Cancer Therapy-Bladder Cancer (FACT-Bl)|Change from Baseline in Patient-Global Impression of Severity (PGIS) Score|Change from Baseline in the Visual Analog Scale (VAS) of the EQ-5D-5L|Change from Baseline in the Utility Scale of the EQ-5D-5L|Duration of Response (DOR)|Number of Participants with Adverse Events (AEs) as a Measure of Safety|Oral Clearance (CL/F) of Erdafitinib|Area Under the Plasma Concentration-Time Curve from Time Zero to Time 't' (AUC[0-t]) of Erdafitinib","PFS is defined as duration in days from date of randomization to disease progression date (assessed per Response Evaluation Criteria in Solid Tumors Version 1.1|ORR is defined as the proportion of participants who achieve CR (CR; disappearance of all target lesions and disappearance of all non-target lesions and normalization of tumor marker level) or partial response (PR; at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters), as assessed per RECIST v1.1 by the investigator.|The FACT-Bl consists of 36 core items, with 5-point Likert response scales, covering 5 primary domains: Physical well-being, social/family well-being, emotional well-being, functional well-being and bladder symptom subscale. The answer scales range from \"Not at all (score=0)\" to \"very much (score=4)\" to assess the meaningful significant symptom deterioration.|The PGIS is a single question regarding the participant report of disease severity. Participants will be asked that ''considering all aspects of your bladder cancer symptoms right now, would you say your bladder cancer symptoms are none, mild, moderate, severe, or very severe?\" The PGIS is an anchor question that will be used to establish the magnitude of meaningful change in this study by assessing disease severity.|European Quality of Life 5 Dimensions (EQ-5D) visual analog scale (VAS) is a 20 centimeter (cm) vertical VAS with scores ranging from 0 (worst imaginable health) to 100 (perfect health). A higher score indicates an improvement in health in the Health Status Index.|The EuroQol-5 is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating \"full health\" and 0 representing dead.|DOR for responders is defined as duration in days from the date of initial documentation of a response to the date of first documented evidence of progressive disease (PD) or relapse for participants who experience CR (CR; disappearance of all target lesions and disappearance of all non-target lesions and normalization of tumor marker level) during the study or death.|An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.|CL/F is the oral clearance; that is clearance based on oral bioavailability of erdafitinib.|AUC(0-t) is the area under the plasma concentration-time curve from time zero to any time 't' of erdafitinib.","RECIST v1.1 by investigator) or relapse from CR or death, whichever is reported first. RECIST 1.1, progressive disease is defined as a 20 percent (%) increase in the sum of diameters of all target lesions and a minimum absolute increase of 5 millimeter (mm) in the sum. CR is defined as disappearance of all target lesions, non-target lesions and normalization of tumor marker level.|Approximately up to 3 years|Baseline up to end of treatment (approximately 3 years)|Baseline up to follow up phase (approximately 3 years)|From the date of initial documentation of a response to date of first documented evidence of progressive disease (or participants relapse who experience CR during the study) or death (approximately up to 3 years)|Day 14 (Cycle 1), Day 1 (Cycle 2) (each cycle is of 21 days)","JNJ.CT@sylogent.com","Study Contact","844-434-4210",{"$cut":{"chars":19009,"head":"Camperdown, Australia, 2050 Peninsula & South Eastern Haematology And Oncology GroupFrankston, Australia, 3199 Royal Hobart HospitalHobart, Australia, 7000 St George HospitalKogarah, Australia, 2217 Peter Maccallum Cancer CentreMelbourne, Australia, 3000 Frankston HospitalMelbourne, Australia, 3199 Fiona Stanley HospitalMurdoch, Australia, 6150|Graz, Austria, 8036 Ordensklinikum Linz Gmbh ElisabethinenLinz, Austria, 4020 Lkh - UniversitÃ¤tsklinikum Der Pmu SalzburgSalzburg, Austria, 5020 Medical University Vienna, MuvVienna, Austria, A-1090|Aalst, Belgium, 9300 Zna MiddelheimAntwerpen, Belgium, 2020 Cliniques Universitaires Saint-LucBrussel, Belgium, 1200 Clinique Notre Dame De GrÃ¢ceCharleroi, Belgium, 6000 Az Maria MiddelaresGent, Belgium, 9000 Uz GentGent, Belgium, 9000 Chc-Cliniques Saint-JosephLiÃ¨ge, Belgium, 4000 Sint-Augustinus AzWilrijk, Belgium, 2610 Chu Dinant Godinne Ucl NamurYvoir, Belgium, 5530|Barretos, Brazil, 14784-400 AssociaÃ§Ã£o MÃ¡rio Penna\\NÃºcleo De Ensino E PesquisasBelo Horizonte, Brazil, 30380-472 Hospital Erasto GaertnerCuritiba, Brazil, 81520-060 Hospital AraÃºjo Jorge Da AssociaÃ§Ã£o De Combate Ao CÃ¢ncer Em GoiÃ¡sGoiÃ¢nia, Brazil, 74605-070 ClÃ­nica De Neoplasias Litoral Ltda.Itajai, Brazil, 88301-220 Upco - HcpaPorto Alegre, Brazil, 90035-903 Inca - Instituto Nacional Do CancerRio De Janeiro, Brazil, 20231-050 OncoclÃ­nicasRio De Janeiro, Brazil, 22250-905 Fundacao Antonio PrudenteSao Paulo, Brazil, 01509900 Ibcc - Instituto Brasileiro De Controle Do CancerSao Paulo, Brazil Hospital De Base De SÃ£o JosÃ© Do Rio PretoSÃ£o JosÃ© Do Rio Preto, Brazil, 15090-000 Sociedade Beneficiante De Senhoras - Hospital Sirio LibanesSÃ£o Paulo, Brazil, 01308901 Instituto D'Or De Pesquisa E Ensino (Idor)SÃ£o Paulo, Brazil, 04502-001 Hospital Israelita Albert EinsteinSÃ£o Paulo, Brazil, 05651-900 Cepho - Faculdade De Medicina Do AbcSÃ£o Paulo, Brazil, 09060-650|Kelowna, British Columbia, Canada, V1Y 5L3 Vancouver Cancer CentreVancouver, British Columbia, Canada, V5Z 4E6|Winnipeg, Manitoba, Canada, R3E 0V9|Thunder Bay, Ontario, Canada, P7B 6V4 Princess Margaret Hospital- UhnToronto, Ontario, Canada, M5G 2M9|Regina, Saskatchewan, Canada, S4T 7T1|Beijing, China, 100021 Peking University First HospitalBeijing, China, 100034 Beijing Friendship HospitalBeijing, China, 100050 Peking University Third HospitalBeijing, China, 100191 Beijing HospitalBeijing, China, 100730 Peking Union Medical College HospitalBeijing, China, 100730 Sichuan Provincial People'S HospitalChengdu, China, 610000 Chongqing Medical UniversityChongqing, China, 400030 Sun Yat-Sen University Cancer CenterGuangzhou, China, 510060 Sun Yat-Sen Memorial Hospital, Sun Yat-Sen UniversityGuangzhou, China, 510120 Guangzhou First Municipal People'S HospitalGuangzhou, China, 510180 Zhejiang Provincial People'S HospitalHangzhou, China, 310014 Sir Run Run Shaw Hospital, Zhejiang UniversityHangzhou, China, 310020 The First Affliated Hospital Of Nanchang UniversityNanchang, China, 330006 Nanjing Drum Tower HospitalNanjing, China, 210008 Jiangsu Cancer HospitalNanjing, China, 210009 Renji Hospital, Shanghai Jiaotong University School Of MedicineShanghai, China, 200127 Huadong Hospital Affiliated To Fudan UniversityShanghai, China, 200400 Shengjing Hospital Of|Shenyang, China, 110004 First Affiliated Hospital, Xi'An Jiaotong UniversityXi'An, China, 710061|Angers, France, 49055 Hopital Jean MinjozBesancon Cedex, France, 25030 Institut BergoniÃ©Bordeaux, France, 33000 Centre Jean PerrinClermont Ferrand, France, 63011 Centre Georges-FranÃ§ois LeclercDijon, France, 21079 Centre Oscar LambretLille, France, 59020 Centre Leon BÃ©rardLyon, France, 69008 Hopital De La TimoneMarseille, France, 13005 Institut Regional Du Cancer De Montpellier Val D'AurelleMontpellier, France, 34298 Centre Antoine LacassagneNice, France, 06189 Institut De CancÃ©rologie Du GardNÃ®mes, France, 30029 Hospital Saint-LouisParis Cedex 10, France, 75475 Hopital Europeen Georges-PompidouParis, France, 75015 Hospices Civils De Lyon HclPierre-BÃ©nite, France, 69495 Chu De PoitiersPoitiers Cedex, France"}},"Alaska|Arizona|California|Colorado|Florida|Georgia|Idaho|Illinois|Kentucky|Michigan|Nebraska|Nevada|New York|North Carolina|Pennsylvania|South Carolina|Texas|Virginia|Washington","Australia|Austria|Belgium|Brazil|Canada|China|France|Germany|Greece|Hungary|India|Israel|Italy|Japan|Mexico|Netherlands|Portugal|Spain|Turkey|Ukraine|United Kingdom|United States","Chris O'Brien Lifehouse|Lkh-Univ. Klinikum Graz|Olv Ziekenhuis Aalst|Fundacao Pio Xii - Hospital De Cancer De Barretos|British Columbia Bc Cancer Agency - Southern Interior|Manitoba Cancercare Manitoba|Ontario Thunder Bay Regional Health Sciences Centre|Saskatchewan Saskatchewan Cancer Agency (Sca) - Allan Blair Cancer Centre|Cancer Hospital Chinese Academy Of Medical Sciences|Medical University|Institut De CancÃ©rologie De L'Ouest (Ico)|Vivantes Klinikum Am Urban|University General Hospital Of Rio Patras|Semmelweis Egyetem|Manipal Comprehensive Cancer Centre, Manipal Hospital|Rambam Health Care Campus|Azienda Ospedaliera Nazionale Ss. Antonio E Biagio E Cesare Arrigo Alessandria|Chiba Cancer Center|San Peregrino Cancer Center|St. Antonius Ziekenhuis Nieuwegein|Hospital LusÃ­adas|Hosp. Univ. Infanta Cristina|Baskent University Adana Practice And Research Center Kisla Health Campus|Based On Kyiv City Clinical Oncology Center|Chernivtsi Regional Clinical Hospital|University Hospitals Bristol - Bristol Haematology & Oncolog|Alaska Urological Institute Dba Alaska Clinical Research Center|University Of Ua Cancer Center(Uacc)/Dh-Sjhmc|University Of California Irvine Medical Center - Chao Family Comprehensive Cancer Center|Uchealth Anschutz Cancer Pavilion|University Of Miami/Sylvester Cancer Center|Piedmont Cancer Institute|St. Luke's Meridian Medical Center|Rush University|Norton Cancer Institute|University Of Michigan Health System|University Of Nebraska Medical Center|Va Sierra Nevada Health Care System|Montefiore Medical Center|Levine Cancer Institute, Carolinas Healthcare System|Penn State Hershey Cancer Institute|University Of Missouri|The Center For Cancer And Blood Disorders|Inova Dwiight &Martha Schar Cancer Institute|Va Puget Sound Healthcare System",{"$nulls":3},"Janssen Research & Development, LLC Clinical Trials","2019-10-16","2020-05-25T16:35:14.208","2020-05-26T17:10:42.972","NCT03390504"]
["5ecbf3c2307e3d1b1f8d9c30","NCT03390504","2019-11-15","Johnson & Johnson","JNJ","Recruiting","A Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Participants With Advanced Urothelial Cancer and Selected Fibroblast Growth Factor Receptor (FGFR) Gene Aberrations","Erdafitinib|Fibroblast|Vinflunine|Docetaxel|Pembrolizumab","FGFR Antagonist|Tubulin Inhibitor|Mitosis Inhibitor|Tubulin Inhibitor|PD-1 Inhibitor","Yes","['Fibroblast', 'Vinflunine']","No",null,"Phase 3",4,631,"Anticipated","2018-03-23","2020-11-24","OS","Overall Survival",{"$nulls":3},"The purpose of this study is to evaluate efficacy of erdafitinib versus chemotherapy or pembrolizumab in participants with advanced urothelial cancer harboring selected fibroblast growth factor receptor (FGFR) aberrations who have progressed after 1 or 2 prior treatments, at least 1 of which includes an anti-PD-(L) 1 agent (cohort 1) or 1 prior treatment not containing an anti-PD-(L) 1 agent (cohort 2).","A study of erdafitinib versus standard of care, consisting of chemotherapy (docetaxel or vinflunine) or anti-PD-(L) 1 agent pembrolizumab, in participants with advanced urothelial cancer and selected FGFR aberrations who have progressed on or after 1 or 2 prior treatments, at least 1 of which includes an anti-PD-(L) 1 agent (cohort 1) or 1 prior treatment not containing an anti-PD-(L) 1 agent (cohort 2). It will consist of screening, treatment phase (from randomization until disease progression, intolerable toxicity, withdrawal of consent or decision by investigator to discontinue treatment, post-treatment followup (from end-of-treatment to participants death, withdraws consent, lost to follow-up, or end of study, whichever comes first). Efficacy, pharmacokinetics, biomarkers, patient reported outcomes, medical resource utilization and safety will be assessed.","A Phase 3 Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Subjects With Advanced Urothelial Cancer and Selected FGFR Gene Aberrations","CR108401","Urothelial Cancer","Transitional Cell Carcinoma","Oncology Solid Tumor","Oncology","Experimental","Cohort 1 (Arm 1A): Erdafitinib|Cohort 1 (Arm 1B): Vinflunine or Docetaxel|Cohort 2 (Arm 2A): Erdafitinib|Cohort 2 (Arm 2B): Pembrolizumab","Participants will be screened based on Fibroblast Growth Factor Receptor inhibitor Clinical Trial Assay (FGFRi CTA) to determine molecular eligibility and participants who meet molecular eligibility criteria will be eligible for full study screening. Participants enrolled in the study (treated with prior anti-programmed cell death protein PD-[L] 1 agent) will swallow erdafitinib tablets orally at a starting dose of 8 milligram (mg), once daily for 21 days in a 21-day cycle until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustment are based on phosphate level and observed toxicity (adverse events [AEs]).|Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be eligible for full study screening. Participants enrolled in the study (treated with prior anti-PD-[L] 1 agent) will receive vinflunine 320 milligram per meter square (mg/m^2) as a 20-minute intravenous infusion once every 3 weeks or docetaxel 75 mg/m^2 as a 1 hour intravenous infusion every 3 weeks. Treatment with either agent (choice of investigator) will be administered until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustments are based on observed toxicities.|Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be eligible for full study screening. Participants enrolled in the study (no prior treatment with anti-PD-[L] 1 agent) will swallow erdafitinib tablets orally at a starting dose of 8 mg, once daily for 21 days in a 21-day cycle until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustments are based on phosphate level and observed toxicity (AEs).|Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be eligible for full study screening. Participants enrolled in the study (no prior treatment with anti-PD-[L] 1 agent) will receive pembrolizumab 200 mg as a 30-minute intravenous infusion once every 3 weeks, until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustments are based on observed toxicities.","Drug|Device","Erdafitinib|Fibroblast Growth Factor Receptor inhibitor Clinical Trial Assay (FGFRi CTA)|Vinflunine|Docetaxel|Pembrolizumab","Participants will swallow erdafitinib tablets orally at a starting dose of 8 mg.|FGFRi CTA will be used to determine molecular eligibility.|Participants will receive vinflunine 320 mg/m^2 as a 20-minute intravenous infusion.|Participants will receive docetaxel 75 mg/m^2 as a 1 hour intravenous infusion.|Participants will receive pembrolizumab 200 mg as a 30-minute intravenous infusion.","JNJ-42756493","Cohort 1 (Arm 1A): Erdafitinib|Cohort 1 (Arm 1B): Vinflunine or Docetaxel|Cohort 2 (Arm 2A): Erdafitinib|Cohort 2 (Arm 2B): Pembrolizumab","\n\n * Histologic demonstration of transitional cell carcinoma of the urothelium. Minor components ( less than [<] 50 percent [%] overall) of variant histology such as glandular or squamous differentiation, or evolution to more aggressive phenotypes such as sarcomatoid or micropapillary change are acceptable\n * Metastatic or surgically unresectable urothelial cancer\n * Documented progression of disease, defined as any progression that requires a change in treatment, prior to randomization\n * Cohort 1: Prior treatment with an anti-PD-(L) 1 agent as monotherapy or as combination therapy; no more than 2 prior lines of systemic treatment. Cohort 2: No prior treatment with an anti-PD-(L) 1 agent; only 1 line of prior systemic treatment. Subjects who received neoadjuvant or adjuvant chemotherapy and showed disease progression within 12 months of the last dose are considered to have received systemic therapy in the metastatic setting.\n * A woman of childbearing potential who is sexually active must have a negative pregnancy test (beta human chorionic gonadotropin [beta hCG]) at Screening (urine or serum)\n * Participants must meet appropriate molecular eligibility criteria\n * Eastern Cooperative Oncology Group (ECOG) performance status Grade 0, 1, or 2\n * Adequate bone marrow, liver, and renal function\n\n","\n\n * Treatment with any other investigational agent or participation in another clinical study with therapeutic intent within 30 days prior to randomization\n * Active malignancies (that is, requiring treatment change in the last 24 months). The only allowed exceptions are: urothelial cancer, skin cancer treated within the last 24 months that is considered completely cured, localized prostate cancer with a gleason score of 6 (treated within the last 24 months or untreated and under surveillance) and localized prostate cancer with a gleason score of 3+4 that has been treated more than 6 months prior to full study screening and considered to have a very low risk of recurrence.\n * Symptomatic central nervous system metastases\n * Received prior fibroblast growth factor receptor (FGFR) inhibitor treatment\n * Known allergies, hypersensitivity, or intolerance to erdafitinib or its excipients\n * Current central serous retinopathy (CSR) or retinal pigment epithelial detachment of any grade.\n * History of uncontrolled cardiovascular disease\n * Impaired wound healing capacity defined as skin/decubitus ulcers, chronic leg ulcers, known gastric ulcers, or unhealed incisions",{"$nulls":4},"Actual","2018-01-04","Actual","Anticipated","2021-11-05","Anticipated","2019-11-01","2017-12-20","2018-01-03","2019-11-14","Yes",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No",null,null,"URL: http://pam.sylogent.com/cr/CR108401 [http://pam.sylogent.com/cr/CR108401] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To learn how to participate in this trial please click here.",null,"Yes","Yes",{"$nulls":17},"2017-002932-18|42756493BLC3001","EudraCT Number|Janssen Research & Development, LLC","Overall Survival (OS)","Overall survival is measured from the date of randomization to the date of the participant's death. If the participant is alive or the vital status is unknown, the participant will be censored at the date the participant was last known to be alive.","Date of first randomization to the date of participant's death (approximately up to 3 years)","Progression-free Survival (PFS)|Overall Response Rate (ORR)|Time to Worsening in Symptom Items and Functioning Subscales in Patient-Reported Health Status of the Functional Assessment of Cancer Therapy-Bladder Cancer (FACT-Bl)|Change from Baseline in Patient-Global Impression of Severity (PGIS) Score|Change from Baseline in the Visual Analog Scale (VAS) of the EQ-5D-5L|Change from Baseline in the Utility Scale of the EQ-5D-5L|Duration of Response (DOR)|Number of Participants with Adverse Events (AEs) as a Measure of Safety|Oral Clearance (CL/F) of Erdafitinib|Area Under the Plasma Concentration-Time Curve from Time Zero to Time 't' (AUC[0-t]) of Erdafitinib","PFS is defined as duration in days from date of randomization to disease progression date (assessed per Response Evaluation Criteria in Solid Tumors Version 1.1|ORR is defined as the proportion of participants who achieve CR (CR; disappearance of all target lesions and disappearance of all non-target lesions and normalization of tumor marker level) or partial response (PR; at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters), as assessed per RECIST v1.1 by the investigator.|The FACT-Bl consists of 36 core items, with 5-point Likert response scales, covering 5 primary domains: Physical well-being, social/family well-being, emotional well-being, functional well-being and bladder symptom subscale. The answer scales range from \"Not at all (score=0)\" to \"very much (score=4)\" to assess the meaningful significant symptom deterioration.|The PGIS is a single question regarding the participant report of disease severity. Participants will be asked that ''considering all aspects of your bladder cancer symptoms right now, would you say your bladder cancer symptoms are none, mild, moderate, severe, or very severe?\" The PGIS is an anchor question that will be used to establish the magnitude of meaningful change in this study by assessing disease severity.|European Quality of Life 5 Dimensions (EQ-5D) visual analog scale (VAS) is a 20 centimeter (cm) vertical VAS with scores ranging from 0 (worst imaginable health) to 100 (perfect health). A higher score indicates an improvement in health in the Health Status Index.|The EuroQol-5 is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating \"full health\" and 0 representing dead.|DOR for responders is defined as duration in days from the date of initial documentation of a response to the date of first documented evidence of progressive disease (PD) or relapse for participants who experience CR (CR; disappearance of all target lesions and disappearance of all non-target lesions and normalization of tumor marker level) during the study or death.|An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.|CL/F is the oral clearance; that is clearance based on oral bioavailability of erdafitinib.|AUC(0-t) is the area under the plasma concentration-time curve from time zero to any time 't' of erdafitinib.","RECIST v1.1 by investigator) or relapse from CR or death, whichever is reported first. RECIST 1.1, progressive disease is defined as a 20 percent (%) increase in the sum of diameters of all target lesions and a minimum absolute increase of 5 millimeter (mm) in the sum. CR is defined as disappearance of all target lesions, non-target lesions and normalization of tumor marker level.|Approximately up to 3 years|Baseline up to end of treatment (approximately 3 years)|Baseline up to follow up phase (approximately 3 years)|From the date of initial documentation of a response to date of first documented evidence of progressive disease (or participants relapse who experience CR during the study) or death (approximately up to 3 years)|Day 14 (Cycle 1), Day 1 (Cycle 2) (each cycle is of 21 days)","JNJ.CT@sylogent.com","Study Contact","844-434-4210",{"$cut":{"chars":18829,"head":"Camperdown, Australia, 2050 Peninsula & South Eastern Haematology And Oncology GroupFrankston, Australia, 3199 Royal Hobart HospitalHobart, Australia, 7000 St George HospitalKogarah, Australia, 2217 Peter Maccallum Cancer CentreMelbourne, Australia, 3000 Frankston HospitalMelbourne, Australia, 3199 Fiona Stanley HospitalMurdoch, Australia, 6150|Graz, Austria, 8036 Ordensklinikum Linz Gmbh ElisabethinenLinz, Austria, 4020 Lkh - UniversitÃ¤tsklinikum Der Pmu SalzburgSalzburg, Austria, 5020 Medical University Vienna, MuvVienna, Austria, A-1090|Aalst, Belgium, 9300 Zna MiddelheimAntwerpen, Belgium, 2020 Cliniques Universitaires Saint-LucBrussel, Belgium, 1200 Clinique Notre Dame De GrÃ¢ceCharleroi, Belgium, 6000 Az Maria MiddelaresGent, Belgium, 9000 Universitair Ziekenhuis GentGent, Belgium, 9000 Chc-Cliniques Saint-JosephLiÃ¨ge, Belgium, 4000 Sint-Augustinus AzWilrijk, Belgium, 2610 Chu Dinant Godinne Ucl NamurYvoir, Belgium, 5530|Barretos, Brazil, 14784-400 AssociaÃ§Ã£o MÃ¡rio Penna/NÃºcleo De Ensino E PesquisasBelo Horizonte, Brazil, 30380-472 Hospital Erasto GaertnerCuritiba, Brazil, 81520-060 Hospital AraÃºjo Jorge Da AssociaÃ§Ã£o De Combate Ao CÃ¢ncer Em GoiÃ¡sGoiÃ¢nia, Brazil, 74605-070 ClÃ­nica De Neoplasias Litoral Ltda.Itajai, Brazil, 88301-220 Upco - HcpaPorto Alegre, Brazil, 90035-903 Inca - Instituto Nacional Do CancerRio De Janeiro, Brazil, 20231-050 OncoclÃ­nicasRio De Janeiro, Brazil, 22250-905 Fundacao Antonio PrudenteSao Paulo, Brazil, 01509900 Ibcc - Instituto Brasileiro De Controle Do CancerSao Paulo, Brazil Hospital De Base De SÃ£o JosÃ© Do Rio PretoSÃ£o JosÃ© Do Rio Preto, Brazil, 15090-000 Sociedade Beneficiante De Senhoras - Hospital Sirio LibanesSÃ£o Paulo, Brazil, 01308901 Instituto D'Or De Pesquisa E Ensino (Idor)SÃ£o Paulo, Brazil, 04502-001 Hospital Israelita Albert EinsteinSÃ£o Paulo, Brazil, 05651-900 Cepho - Faculdade De Medicina Do AbcSÃ£o Paulo, Brazil, 09060-650|Kelowna, British Columbia, Canada, V1Y 5L3 Vancouver Cancer CentreVancouver, British Columbia, Canada, V5Z 4E6|Winnipeg, Manitoba, Canada, R3E 0V9|Thunder Bay, Ontario, Canada, P7B 6V4 Princess Margaret Hospital- UhnToronto, Ontario, Canada, M5G 2M9|Regina, Saskatchewan, Canada, S4T 7T1|Beijing, China, 100021 Peking University First HospitalBeijing, China, 100034 Beijing Friendship HospitalBeijing, China, 100050 Peking University Third HospitalBeijing, China, 100191 Beijing HospitalBeijing, China, 100730 Peking Union Medical College HospitalBeijing, China, 100730 Sichuan Provincial People'S HospitalChengdu, China, 610000 Chongqing Medical UniversityChongqing, China, 400030 Sun Yat-Sen University Cancer CenterGuangzhou, China, 510060 Sun Yat-Sen Memorial Hospital, Sun Yat-Sen UniversityGuangzhou, China, 510120 Guangzhou First Municipal People'S HospitalGuangzhou, China, 510180 Zhejiang Provincial People'S HospitalHangzhou, China, 310014 Sir Run Run Shaw Hospital, Zhejiang UniversityHangzhou, China, 310020 The First Affliated Hospital Of Nanchang UniversityNanchang, China, 330006 Nanjing Drum Tower HospitalNanjing, China, 210008 Jiangsu Cancer HospitalNanjing, China, 210009 Renji Hospital, Shanghai Jiaotong University School Of MedicineShanghai, China, 200127 Huadong Hospital Affiliated To Fudan UniversityShanghai, China, 200400 Shengjing Hospital Of|Shenyang, China, 110004 First Affiliated Hospital, Xi'An Jiaotong UniversityXi'An, China, 710061|Angers, France, 49055 Hopital Jean MinjozBesancon Cedex, France, 25030 Institut BergoniÃ©Bordeaux, France, 33000 Centre Jean PerrinClermont Ferrand, France, 63011 Centre Georges-FranÃ§ois LeclercDijon, France, 21079 Centre Oscar LambretLille, France, 59020 Centre Leon BÃ©rardLyon, France, 69008 Hopital De La TimoneMarseille, France, 13005 Institut Regional Du Cancer De Montpellier Val D'AurelleMontpellier, France, 34298 Centre Antoine LacassagneNice, France, 06189 Institut De CancÃ©rologie Du GardNÃ®mes, France, 30029 Hospital Saint-LouisParis Cedex 10, France, 75475 Hopital Europeen Georges-PompidouParis, France, 75015 Hospices Civils De Lyon HclPierre-BÃ©nite, France, 69495 Chu De PoitiersP"}},"Alaska|Arizona|California|Colorado|Florida|Georgia|Idaho|Illinois|Kentucky|Michigan|Nebraska|Nevada|New York|North Carolina|Pennsylvania|South Carolina|Texas|Virginia|Washington","Australia|Austria|Belgium|Brazil|Canada|China|France|Germany|Greece|Hungary|Israel|Italy|Japan|Mexico|Netherlands|Portugal|Spain|Turkey|Ukraine|United Kingdom|United States","Chris O'Brien Lifehouse|Lkh-Univ. Klinikum Graz|Olv Ziekenhuis Aalst|Fundacao Pio Xii - Hospital De Cancer De Barretos|British Columbia Bc Cancer Agency - Southern Interior|Manitoba Cancercare Manitoba|Ontario Thunder Bay Regional Health Sciences Centre|Saskatchewan Saskatchewan Cancer Agency (Sca) - Allan Blair Cancer Centre|Cancer Hospital Chinese Academy Of Medical Sciences|Medical University|Institut De CancÃ©rologie De L'Ouest (Ico)|Vivantes Klinikum Am Urban|University General Hospital Of Rio Patras|Semmelweis Egyetem|Rambam Health Care Campus|Azienda Ospedaliera Nazionale Ss. Antonio E Biagio E Cesare Arrigo Alessandria|Chiba Cancer Center|San Peregrino Cancer Center|St. Antonius Ziekenhuis Nieuwegein|Hospital LusÃ­adas|Hosp. Univ. Infanta Cristina|Baskent University Adana Practice And Research Center Kisla Health Campus|Based On Kyiv City Clinical Oncology Center|Chernivtsi Regional Clinical Hospital|University Hospitals Bristol - Bristol Haematology & Oncolog|Alaska Urological Institute Dba Alaska Clinical Research Center|University Of Ua Cancer Center(Uacc)/Dh-Sjhmc|University Of California Irvine Medical Center - Chao Family Comprehensive Cancer Center|Uchealth Anschutz Cancer Pavilion|University Of Miami/Sylvester Cancer Center|Piedmont Cancer Institute|St. Luke's Meridian Medical Center|Rush University|Norton Cancer Institute|University Of Michigan Health System|University Of Nebraska Medical Center|Va Sierra Nevada Health Care System|Montefiore Medical Center|Levine Cancer Institute, Carolinas Healthcare System|Penn State Hershey Cancer Institute|University Of Missouri|The Center For Cancer And Blood Disorders|Inova Dwiight &Martha Schar Cancer Institute|Va Puget Sound Healthcare System",{"$nulls":3},"Janssen Research & Development, LLC Clinical Trials","2019-11-14","2020-05-25T16:35:14.269","2020-05-26T17:10:42.972","NCT03390504"]
["5ecbf3c2feab101b155307d0","NCT03390504","2019-12-12","Johnson & Johnson","JNJ","Recruiting","A Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Participants With Advanced Urothelial Cancer and Selected Fibroblast Growth Factor Receptor (FGFR) Gene Aberrations","Erdafitinib|Fibroblast|Vinflunine|Docetaxel|Pembrolizumab","FGFR Antagonist|Tubulin Inhibitor|Mitosis Inhibitor|Tubulin Inhibitor|PD-1 Inhibitor","Yes","['Fibroblast', 'Vinflunine']","No",null,"Phase 3",4,631,"Anticipated","2018-03-23","2020-11-24","OS","Overall Survival",{"$nulls":3},"The purpose of this study is to evaluate efficacy of erdafitinib versus chemotherapy or pembrolizumab in participants with advanced urothelial cancer harboring selected fibroblast growth factor receptor (FGFR) aberrations who have progressed after 1 or 2 prior treatments, at least 1 of which includes an anti-PD-(L) 1 agent (cohort 1) or 1 prior treatment not containing an anti-PD-(L) 1 agent (cohort 2).","A study of erdafitinib versus standard of care, consisting of chemotherapy (docetaxel or vinflunine) or anti-PD-(L) 1 agent pembrolizumab, in participants with advanced urothelial cancer and selected FGFR aberrations who have progressed on or after 1 or 2 prior treatments, at least 1 of which includes an anti-PD-(L) 1 agent (cohort 1) or 1 prior treatment not containing an anti-PD-(L) 1 agent (cohort 2). It will consist of screening, treatment phase (from randomization until disease progression, intolerable toxicity, withdrawal of consent or decision by investigator to discontinue treatment, post-treatment followup (from end-of-treatment to participants death, withdraws consent, lost to follow-up, or end of study, whichever comes first). Efficacy, pharmacokinetics, biomarkers, patient reported outcomes, medical resource utilization and safety will be assessed.","A Phase 3 Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Subjects With Advanced Urothelial Cancer and Selected FGFR Gene Aberrations","CR108401","Urothelial Cancer","Transitional Cell Carcinoma","Oncology Solid Tumor","Oncology","Experimental","Cohort 1 (Arm 1A): Erdafitinib|Cohort 1 (Arm 1B): Vinflunine or Docetaxel|Cohort 2 (Arm 2A): Erdafitinib|Cohort 2 (Arm 2B): Pembrolizumab","Participants will be screened based on Fibroblast Growth Factor Receptor inhibitor Clinical Trial Assay (FGFRi CTA) to determine molecular eligibility and participants who meet molecular eligibility criteria will be eligible for full study screening. Participants enrolled in the study (treated with prior anti-programmed cell death protein PD-[L] 1 agent) will swallow erdafitinib tablets orally at a starting dose of 8 milligram (mg), once daily for 21 days in a 21-day cycle until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustment are based on phosphate level and observed toxicity (adverse events [AEs]).|Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be eligible for full study screening. Participants enrolled in the study (treated with prior anti-PD-[L] 1 agent) will receive vinflunine 320 milligram per meter square (mg/m^2) as a 20-minute intravenous infusion once every 3 weeks or docetaxel 75 mg/m^2 as a 1 hour intravenous infusion every 3 weeks. Treatment with either agent (choice of investigator) will be administered until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustments are based on observed toxicities.|Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be eligible for full study screening. Participants enrolled in the study (no prior treatment with anti-PD-[L] 1 agent) will swallow erdafitinib tablets orally at a starting dose of 8 mg, once daily for 21 days in a 21-day cycle until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustments are based on phosphate level and observed toxicity (AEs).|Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be eligible for full study screening. Participants enrolled in the study (no prior treatment with anti-PD-[L] 1 agent) will receive pembrolizumab 200 mg as a 30-minute intravenous infusion once every 3 weeks, until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustments are based on observed toxicities.","Drug|Device","Erdafitinib|Fibroblast Growth Factor Receptor inhibitor Clinical Trial Assay (FGFRi CTA)|Vinflunine|Docetaxel|Pembrolizumab","Participants will swallow erdafitinib tablets orally at a starting dose of 8 mg.|FGFRi CTA will be used to determine molecular eligibility.|Participants will receive vinflunine 320 mg/m^2 as a 20-minute intravenous infusion.|Participants will receive docetaxel 75 mg/m^2 as a 1 hour intravenous infusion.|Participants will receive pembrolizumab 200 mg as a 30-minute intravenous infusion.","JNJ-42756493","Cohort 1 (Arm 1A): Erdafitinib|Cohort 1 (Arm 1B): Vinflunine or Docetaxel|Cohort 2 (Arm 2A): Erdafitinib|Cohort 2 (Arm 2B): Pembrolizumab","\n\n * Histologic demonstration of transitional cell carcinoma of the urothelium. Minor components ( less than [<] 50 percent [%] overall) of variant histology such as glandular or squamous differentiation, or evolution to more aggressive phenotypes such as sarcomatoid or micropapillary change are acceptable\n * Metastatic or surgically unresectable urothelial cancer\n * Documented progression of disease, defined as any progression that requires a change in treatment, prior to randomization\n * Cohort 1: Prior treatment with an anti-PD-(L) 1 agent as monotherapy or as combination therapy; no more than 2 prior lines of systemic treatment. Cohort 2: No prior treatment with an anti-PD-(L) 1 agent; only 1 line of prior systemic treatment. Subjects who received neoadjuvant or adjuvant chemotherapy and showed disease progression within 12 months of the last dose are considered to have received systemic therapy in the metastatic setting.\n * A woman of childbearing potential who is sexually active must have a negative pregnancy test (beta human chorionic gonadotropin [beta hCG]) at Screening (urine or serum)\n * Participants must meet appropriate molecular eligibility criteria\n * Eastern Cooperative Oncology Group (ECOG) performance status Grade 0, 1, or 2\n * Adequate bone marrow, liver, and renal function\n\n","\n\n * Treatment with any other investigational agent or participation in another clinical study with therapeutic intent within 30 days prior to randomization\n * Active malignancies (that is, requiring treatment change in the last 24 months). The only allowed exceptions are: urothelial cancer, skin cancer treated within the last 24 months that is considered completely cured, localized prostate cancer with a gleason score of 6 (treated within the last 24 months or untreated and under surveillance) and localized prostate cancer with a gleason score of 3+4 that has been treated more than 6 months prior to full study screening and considered to have a very low risk of recurrence.\n * Symptomatic central nervous system metastases\n * Received prior fibroblast growth factor receptor (FGFR) inhibitor treatment\n * Known allergies, hypersensitivity, or intolerance to erdafitinib or its excipients\n * Current central serous retinopathy (CSR) or retinal pigment epithelial detachment of any grade.\n * History of uncontrolled cardiovascular disease\n * Impaired wound healing capacity defined as skin/decubitus ulcers, chronic leg ulcers, known gastric ulcers, or unhealed incisions",{"$nulls":4},"Actual","2018-01-04","Actual","Anticipated","2021-11-05","Anticipated","2019-12-01","2017-12-20","2018-01-03","2019-12-11","Yes",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No",null,null,"URL: http://pam.sylogent.com/cr/CR108401 [http://pam.sylogent.com/cr/CR108401] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To learn how to participate in this trial please click here.",null,"Yes","Yes",{"$nulls":17},"2017-002932-18|42756493BLC3001","EudraCT Number|Janssen Research & Development, LLC","Overall Survival (OS)","Overall survival is measured from the date of randomization to the date of the participant's death. If the participant is alive or the vital status is unknown, the participant will be censored at the date the participant was last known to be alive.","Date of first randomization to the date of participant's death (approximately up to 3 years)","Progression-free Survival (PFS)|Overall Response Rate (ORR)|Time to Worsening in Symptom Items and Functioning Subscales in Patient-Reported Health Status of the Functional Assessment of Cancer Therapy-Bladder Cancer (FACT-Bl)|Change from Baseline in Patient-Global Impression of Severity (PGIS) Score|Change from Baseline in the Visual Analog Scale (VAS) of the EQ-5D-5L|Change from Baseline in the Utility Scale of the EQ-5D-5L|Duration of Response (DOR)|Number of Participants with Adverse Events (AEs) as a Measure of Safety|Oral Clearance (CL/F) of Erdafitinib|Area Under the Plasma Concentration-Time Curve from Time Zero to Time 't' (AUC[0-t]) of Erdafitinib","PFS is defined as duration in days from date of randomization to disease progression date (assessed per Response Evaluation Criteria in Solid Tumors Version 1.1|ORR is defined as the proportion of participants who achieve CR (CR; disappearance of all target lesions and disappearance of all non-target lesions and normalization of tumor marker level) or partial response (PR; at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters), as assessed per RECIST v1.1 by the investigator.|The FACT-Bl consists of 36 core items, with 5-point Likert response scales, covering 5 primary domains: Physical well-being, social/family well-being, emotional well-being, functional well-being and bladder symptom subscale. The answer scales range from \"Not at all (score=0)\" to \"very much (score=4)\" to assess the meaningful significant symptom deterioration.|The PGIS is a single question regarding the participant report of disease severity. Participants will be asked that ''considering all aspects of your bladder cancer symptoms right now, would you say your bladder cancer symptoms are none, mild, moderate, severe, or very severe?\" The PGIS is an anchor question that will be used to establish the magnitude of meaningful change in this study by assessing disease severity.|European Quality of Life 5 Dimensions (EQ-5D) visual analog scale (VAS) is a 20 centimeter (cm) vertical VAS with scores ranging from 0 (worst imaginable health) to 100 (perfect health). A higher score indicates an improvement in health in the Health Status Index.|The EuroQol-5 is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating \"full health\" and 0 representing dead.|DOR for responders is defined as duration in days from the date of initial documentation of a response to the date of first documented evidence of progressive disease (PD) or relapse for participants who experience CR (CR; disappearance of all target lesions and disappearance of all non-target lesions and normalization of tumor marker level) during the study or death.|An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.|CL/F is the oral clearance; that is clearance based on oral bioavailability of erdafitinib.|AUC(0-t) is the area under the plasma concentration-time curve from time zero to any time 't' of erdafitinib.","RECIST v1.1 by investigator) or relapse from CR or death, whichever is reported first. RECIST 1.1, progressive disease is defined as a 20 percent (%) increase in the sum of diameters of all target lesions and a minimum absolute increase of 5 millimeter (mm) in the sum. CR is defined as disappearance of all target lesions, non-target lesions and normalization of tumor marker level.|Approximately up to 3 years|Baseline up to end of treatment (approximately 3 years)|Baseline up to follow up phase (approximately 3 years)|From the date of initial documentation of a response to date of first documented evidence of progressive disease (or participants relapse who experience CR during the study) or death (approximately up to 3 years)|Day 14 (Cycle 1), Day 1 (Cycle 2) (each cycle is of 21 days)","JNJ.CT@sylogent.com","Study Contact","844-434-4210",{"$cut":{"chars":18944,"head":"Camperdown, Australia, 2050 Peninsula & South Eastern Haematology And Oncology GroupFrankston, Australia, 3199 Royal Hobart HospitalHobart, Australia, 7000 St George HospitalKogarah, Australia, 2217 Peter Maccallum Cancer CentreMelbourne, Australia, 3000 Frankston HospitalMelbourne, Australia, 3199 Fiona Stanley HospitalMurdoch, Australia, 6150|Graz, Austria, 8036 Ordensklinikum Linz Gmbh ElisabethinenLinz, Austria, 4020 Lkh - UniversitÃ¤tsklinikum Der Pmu SalzburgSalzburg, Austria, 5020 Medical University Vienna, MuvVienna, Austria, A-1090|Aalst, Belgium, 9300 Zna MiddelheimAntwerpen, Belgium, 2020 Cliniques Universitaires Saint-LucBrussel, Belgium, 1200 Clinique Notre Dame De GrÃ¢ceCharleroi, Belgium, 6000 Az Maria MiddelaresGent, Belgium, 9000 Uz GentGent, Belgium, 9000 Chc-Cliniques Saint-JosephLiÃ¨ge, Belgium, 4000 Sint-Augustinus AzWilrijk, Belgium, 2610 Chu Dinant Godinne Ucl NamurYvoir, Belgium, 5530|Barretos, Brazil, 14784-400 AssociaÃ§Ã£o MÃ¡rio Penna/NÃºcleo De Ensino E PesquisasBelo Horizonte, Brazil, 30380-472 Hospital Erasto GaertnerCuritiba, Brazil, 81520-060 Hospital AraÃºjo Jorge Da AssociaÃ§Ã£o De Combate Ao CÃ¢ncer Em GoiÃ¡sGoiÃ¢nia, Brazil, 74605-070 ClÃ­nica De Neoplasias Litoral Ltda.Itajai, Brazil, 88301-220 Upco - HcpaPorto Alegre, Brazil, 90035-903 Inca - Instituto Nacional Do CancerRio De Janeiro, Brazil, 20231-050 OncoclÃ­nicasRio De Janeiro, Brazil, 22250-905 Fundacao Antonio PrudenteSao Paulo, Brazil, 01509900 Ibcc - Instituto Brasileiro De Controle Do CancerSao Paulo, Brazil Hospital De Base De SÃ£o JosÃ© Do Rio PretoSÃ£o JosÃ© Do Rio Preto, Brazil, 15090-000 Sociedade Beneficiante De Senhoras - Hospital Sirio LibanesSÃ£o Paulo, Brazil, 01308901 Instituto D'Or De Pesquisa E Ensino (Idor)SÃ£o Paulo, Brazil, 04502-001 Hospital Israelita Albert EinsteinSÃ£o Paulo, Brazil, 05651-900 Cepho - Faculdade De Medicina Do AbcSÃ£o Paulo, Brazil, 09060-650|Kelowna, British Columbia, Canada, V1Y 5L3 Vancouver Cancer CentreVancouver, British Columbia, Canada, V5Z 4E6|Winnipeg, Manitoba, Canada, R3E 0V9|Thunder Bay, Ontario, Canada, P7B 6V4 Princess Margaret Hospital- UhnToronto, Ontario, Canada, M5G 2M9|Regina, Saskatchewan, Canada, S4T 7T1|Beijing, China, 100021 Peking University First HospitalBeijing, China, 100034 Beijing Friendship HospitalBeijing, China, 100050 Peking University Third HospitalBeijing, China, 100191 Beijing HospitalBeijing, China, 100730 Peking Union Medical College HospitalBeijing, China, 100730 Sichuan Provincial People'S HospitalChengdu, China, 610000 Chongqing Medical UniversityChongqing, China, 400030 Sun Yat-Sen University Cancer CenterGuangzhou, China, 510060 Sun Yat-Sen Memorial Hospital, Sun Yat-Sen UniversityGuangzhou, China, 510120 Guangzhou First Municipal People'S HospitalGuangzhou, China, 510180 Zhejiang Provincial People'S HospitalHangzhou, China, 310014 Sir Run Run Shaw Hospital, Zhejiang UniversityHangzhou, China, 310020 The First Affliated Hospital Of Nanchang UniversityNanchang, China, 330006 Nanjing Drum Tower HospitalNanjing, China, 210008 Jiangsu Cancer HospitalNanjing, China, 210009 Renji Hospital, Shanghai Jiaotong University School Of MedicineShanghai, China, 200127 Huadong Hospital Affiliated To Fudan UniversityShanghai, China, 200400 Shengjing Hospital Of|Shenyang, China, 110004 First Affiliated Hospital, Xi'An Jiaotong UniversityXi'An, China, 710061|Angers, France, 49055 Hopital Jean MinjozBesancon Cedex, France, 25030 Institut BergoniÃ©Bordeaux, France, 33000 Centre Jean PerrinClermont Ferrand, France, 63011 Centre Georges-FranÃ§ois LeclercDijon, France, 21079 Centre Oscar LambretLille, France, 59020 Centre Leon BÃ©rardLyon, France, 69008 Hopital De La TimoneMarseille, France, 13005 Institut Regional Du Cancer De Montpellier Val D'AurelleMontpellier, France, 34298 Centre Antoine LacassagneNice, France, 06189 Institut De CancÃ©rologie Du GardNÃ®mes, France, 30029 Hospital Saint-LouisParis Cedex 10, France, 75475 Hopital Europeen Georges-PompidouParis, France, 75015 Hospices Civils De Lyon HclPierre-BÃ©nite, France, 69495 Chu De PoitiersPoitiers Cedex, France"}},"Alaska|Arizona|California|Colorado|Florida|Georgia|Idaho|Illinois|Kentucky|Michigan|Nebraska|Nevada|New York|North Carolina|Pennsylvania|South Carolina|Texas|Virginia|Washington","Australia|Austria|Belgium|Brazil|Canada|China|France|Germany|Greece|Hungary|Israel|Italy|Japan|Mexico|Netherlands|Portugal|Spain|Turkey|Ukraine|United Kingdom|United States","Chris O'Brien Lifehouse|Lkh-Univ. Klinikum Graz|Olv Ziekenhuis Aalst|Fundacao Pio Xii - Hospital De Cancer De Barretos|British Columbia Bc Cancer Agency - Southern Interior|Manitoba Cancercare Manitoba|Ontario Thunder Bay Regional Health Sciences Centre|Saskatchewan Saskatchewan Cancer Agency (Sca) - Allan Blair Cancer Centre|Cancer Hospital Chinese Academy Of Medical Sciences|Medical University|Institut De CancÃ©rologie De L'Ouest (Ico)|Vivantes Klinikum Am Urban|University General Hospital Of Rio Patras|Semmelweis Egyetem|Rambam Health Care Campus|Azienda Ospedaliera Nazionale Ss. Antonio E Biagio E Cesare Arrigo Alessandria|Chiba Cancer Center|San Peregrino Cancer Center|St. Antonius Ziekenhuis Nieuwegein|Hospital LusÃ­adas|Hosp. Univ. Infanta Cristina|Baskent University Adana Practice And Research Center Kisla Health Campus|Based On Kyiv City Clinical Oncology Center|Chernivtsi Regional Clinical Hospital|University Hospitals Bristol - Bristol Haematology & Oncolog|Alaska Urological Institute Dba Alaska Clinical Research Center|University Of Ua Cancer Center(Uacc)/Dh-Sjhmc|University Of California Irvine Medical Center - Chao Family Comprehensive Cancer Center|Uchealth Anschutz Cancer Pavilion|University Of Miami/Sylvester Cancer Center|Piedmont Cancer Institute|St. Luke's Meridian Medical Center|Rush University|Norton Cancer Institute|University Of Michigan Health System|University Of Nebraska Medical Center|Va Sierra Nevada Health Care System|Montefiore Medical Center|Levine Cancer Institute, Carolinas Healthcare System|Penn State Hershey Cancer Institute|University Of Missouri|The Center For Cancer And Blood Disorders|Inova Dwiight &Martha Schar Cancer Institute|Va Puget Sound Healthcare System",{"$nulls":3},"Janssen Research & Development, LLC Clinical Trials","2019-12-11","2020-05-25T16:35:14.303","2020-05-26T17:10:42.972","NCT03390504"]
["5ecbf3c211702c1b1b9169b4","NCT03390504","2020-01-13","Johnson & Johnson","JNJ","Recruiting","A Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Participants With Advanced Urothelial Cancer and Selected Fibroblast Growth Factor Receptor (FGFR) Gene Aberrations","Erdafitinib|Fibroblast|Vinflunine|Docetaxel|Pembrolizumab","FGFR Antagonist|Tubulin Inhibitor|Mitosis Inhibitor|Tubulin Inhibitor|PD-1 Inhibitor","Yes","['Fibroblast', 'Vinflunine']","No",null,"Phase 3",4,631,"Anticipated","2018-03-23","2020-11-24","OS","Overall Survival",{"$nulls":3},"The purpose of this study is to evaluate efficacy of erdafitinib versus chemotherapy or pembrolizumab in participants with advanced urothelial cancer harboring selected fibroblast growth factor receptor (FGFR) aberrations who have progressed after 1 or 2 prior treatments, at least 1 of which includes an anti-PD-(L) 1 agent (cohort 1) or 1 prior treatment not containing an anti-PD-(L) 1 agent (cohort 2).","A study of erdafitinib versus standard of care, consisting of chemotherapy (docetaxel or vinflunine) or anti-PD-(L) 1 agent pembrolizumab, in participants with advanced urothelial cancer and selected FGFR aberrations who have progressed on or after 1 or 2 prior treatments, at least 1 of which includes an anti-PD-(L) 1 agent (cohort 1) or 1 prior treatment not containing an anti-PD-(L) 1 agent (cohort 2). It will consist of screening, treatment phase (from randomization until disease progression, intolerable toxicity, withdrawal of consent or decision by investigator to discontinue treatment, post-treatment followup (from end-of-treatment to participants death, withdraws consent, lost to follow-up, or end of study, whichever comes first). Efficacy, pharmacokinetics, biomarkers, patient reported outcomes, medical resource utilization and safety will be assessed.","A Phase 3 Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Subjects With Advanced Urothelial Cancer and Selected FGFR Gene Aberrations","CR108401","Urothelial Cancer","Transitional Cell Carcinoma","Oncology Solid Tumor","Oncology","Experimental","Cohort 1 (Arm 1A): Erdafitinib|Cohort 1 (Arm 1B): Vinflunine or Docetaxel|Cohort 2 (Arm 2A): Erdafitinib|Cohort 2 (Arm 2B): Pembrolizumab","Participants will be screened based on Fibroblast Growth Factor Receptor inhibitor Clinical Trial Assay (FGFRi CTA) to determine molecular eligibility and participants who meet molecular eligibility criteria will be eligible for full study screening. Participants enrolled in the study (treated with prior anti-programmed cell death protein PD-[L] 1 agent) will swallow erdafitinib tablets orally at a starting dose of 8 milligram (mg), once daily for 21 days in a 21-day cycle until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustment are based on phosphate level and observed toxicity (adverse events [AEs]).|Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be eligible for full study screening. Participants enrolled in the study (treated with prior anti-PD-[L] 1 agent) will receive vinflunine 320 milligram per meter square (mg/m^2) as a 20-minute intravenous infusion once every 3 weeks or docetaxel 75 mg/m^2 as a 1 hour intravenous infusion every 3 weeks. Treatment with either agent (choice of investigator) will be administered until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustments are based on observed toxicities.|Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be eligible for full study screening. Participants enrolled in the study (no prior treatment with anti-PD-[L] 1 agent) will swallow erdafitinib tablets orally at a starting dose of 8 mg, once daily for 21 days in a 21-day cycle until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustments are based on phosphate level and observed toxicity (AEs).|Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be eligible for full study screening. Participants enrolled in the study (no prior treatment with anti-PD-[L] 1 agent) will receive pembrolizumab 200 mg as a 30-minute intravenous infusion once every 3 weeks, until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustments are based on observed toxicities.","Drug|Device","Erdafitinib|Fibroblast Growth Factor Receptor inhibitor Clinical Trial Assay (FGFRi CTA)|Vinflunine|Docetaxel|Pembrolizumab","Participants will swallow erdafitinib tablets orally at a starting dose of 8 mg.|FGFRi CTA will be used to determine molecular eligibility.|Participants will receive vinflunine 320 mg/m^2 as a 20-minute intravenous infusion.|Participants will receive docetaxel 75 mg/m^2 as a 1 hour intravenous infusion.|Participants will receive pembrolizumab 200 mg as a 30-minute intravenous infusion.","JNJ-42756493","Cohort 1 (Arm 1A): Erdafitinib|Cohort 1 (Arm 1B): Vinflunine or Docetaxel|Cohort 2 (Arm 2A): Erdafitinib|Cohort 2 (Arm 2B): Pembrolizumab","\n\n * Histologic demonstration of transitional cell carcinoma of the urothelium. Minor components ( less than [<] 50 percent [%] overall) of variant histology such as glandular or squamous differentiation, or evolution to more aggressive phenotypes such as sarcomatoid or micropapillary change are acceptable\n * Metastatic or surgically unresectable urothelial cancer\n * Documented progression of disease, defined as any progression that requires a change in treatment, prior to randomization\n * Cohort 1: Prior treatment with an anti-PD-(L) 1 agent as monotherapy or as combination therapy; no more than 2 prior lines of systemic treatment. Cohort 2: No prior treatment with an anti-PD-(L) 1 agent; only 1 line of prior systemic treatment. Subjects who received neoadjuvant or adjuvant chemotherapy and showed disease progression within 12 months of the last dose are considered to have received systemic therapy in the metastatic setting.\n * A woman of childbearing potential who is sexually active must have a negative pregnancy test (beta human chorionic gonadotropin [beta hCG]) at Screening (urine or serum)\n * Participants must meet appropriate molecular eligibility criteria\n * Eastern Cooperative Oncology Group (ECOG) performance status Grade 0, 1, or 2\n * Adequate bone marrow, liver, and renal function\n\n","\n\n * Treatment with any other investigational agent or participation in another clinical study with therapeutic intent within 30 days prior to randomization\n * Active malignancies (that is, requiring treatment change in the last 24 months). The only allowed exceptions are: urothelial cancer, skin cancer treated within the last 24 months that is considered completely cured, localized prostate cancer with a gleason score of 6 (treated within the last 24 months or untreated and under surveillance) and localized prostate cancer with a gleason score of 3+4 that has been treated more than 6 months prior to full study screening and considered to have a very low risk of recurrence.\n * Symptomatic central nervous system metastases\n * Received prior fibroblast growth factor receptor (FGFR) inhibitor treatment\n * Known allergies, hypersensitivity, or intolerance to erdafitinib or its excipients\n * Current central serous retinopathy (CSR) or retinal pigment epithelial detachment of any grade.\n * History of uncontrolled cardiovascular disease\n * Impaired wound healing capacity defined as skin/decubitus ulcers, chronic leg ulcers, known gastric ulcers, or unhealed incisions",{"$nulls":4},"Actual","2018-01-04","Actual","Anticipated","2021-11-05","Anticipated","2020-01-01","2017-12-20","2018-01-03","2020-01-09","Yes",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No",null,null,"URL: http://pam.sylogent.com/cr/CR108401 [http://pam.sylogent.com/cr/CR108401] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To learn how to participate in this trial please click here.",null,"Yes","Yes",{"$nulls":17},"2017-002932-18|42756493BLC3001","EudraCT Number|Janssen Research & Development, LLC","Overall Survival (OS)","Overall survival is measured from the date of randomization to the date of the participant's death. If the participant is alive or the vital status is unknown, the participant will be censored at the date the participant was last known to be alive.","Date of first randomization to the date of participant's death (approximately up to 3 years)","Progression-free Survival (PFS)|Overall Response Rate (ORR)|Time to Worsening in Symptom Items and Functioning Subscales in Patient-Reported Health Status of the Functional Assessment of Cancer Therapy-Bladder Cancer (FACT-Bl)|Change from Baseline in Patient-Global Impression of Severity (PGIS) Score|Change from Baseline in the Visual Analog Scale (VAS) of the EQ-5D-5L|Change from Baseline in the Utility Scale of the EQ-5D-5L|Duration of Response (DOR)|Number of Participants with Adverse Events (AEs) as a Measure of Safety|Oral Clearance (CL/F) of Erdafitinib|Area Under the Plasma Concentration-Time Curve from Time Zero to Time 't' (AUC[0-t]) of Erdafitinib","PFS is defined as duration in days from date of randomization to disease progression date (assessed per Response Evaluation Criteria in Solid Tumors Version 1.1|ORR is defined as the proportion of participants who achieve CR (CR; disappearance of all target lesions and disappearance of all non-target lesions and normalization of tumor marker level) or partial response (PR; at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters), as assessed per RECIST v1.1 by the investigator.|The FACT-Bl consists of 36 core items, with 5-point Likert response scales, covering 5 primary domains: Physical well-being, social/family well-being, emotional well-being, functional well-being and bladder symptom subscale. The answer scales range from \"Not at all (score=0)\" to \"very much (score=4)\" to assess the meaningful significant symptom deterioration.|The PGIS is a single question regarding the participant report of disease severity. Participants will be asked that ''considering all aspects of your bladder cancer symptoms right now, would you say your bladder cancer symptoms are none, mild, moderate, severe, or very severe?\" The PGIS is an anchor question that will be used to establish the magnitude of meaningful change in this study by assessing disease severity.|European Quality of Life 5 Dimensions (EQ-5D) visual analog scale (VAS) is a 20 centimeter (cm) vertical VAS with scores ranging from 0 (worst imaginable health) to 100 (perfect health). A higher score indicates an improvement in health in the Health Status Index.|The EuroQol-5 is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating \"full health\" and 0 representing dead.|DOR for responders is defined as duration in days from the date of initial documentation of a response to the date of first documented evidence of progressive disease (PD) or relapse for participants who experience CR (CR; disappearance of all target lesions and disappearance of all non-target lesions and normalization of tumor marker level) during the study or death.|An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.|CL/F is the oral clearance; that is clearance based on oral bioavailability of erdafitinib.|AUC(0-t) is the area under the plasma concentration-time curve from time zero to any time 't' of erdafitinib.","RECIST v1.1 by investigator) or relapse from CR or death, whichever is reported first. RECIST 1.1, progressive disease is defined as a 20 percent (%) increase in the sum of diameters of all target lesions and a minimum absolute increase of 5 millimeter (mm) in the sum. CR is defined as disappearance of all target lesions, non-target lesions and normalization of tumor marker level.|Approximately up to 3 years|Baseline up to end of treatment (approximately 3 years)|Baseline up to follow up phase (approximately 3 years)|From the date of initial documentation of a response to date of first documented evidence of progressive disease (or participants relapse who experience CR during the study) or death (approximately up to 3 years)|Day 14 (Cycle 1), Day 1 (Cycle 2) (each cycle is of 21 days)","JNJ.CT@sylogent.com","Study Contact","844-434-4210",{"$cut":{"chars":19037,"head":"Camperdown, Australia, 2050 Peninsula & South Eastern Haematology And Oncology GroupFrankston, Australia, 3199 Royal Hobart HospitalHobart, Australia, 7000 St George HospitalKogarah, Australia, 2217 Peter Maccallum Cancer CentreMelbourne, Australia, 3000 Frankston HospitalMelbourne, Australia, 3199 Fiona Stanley HospitalMurdoch, Australia, 6150|Graz, Austria, 8036 Ordensklinikum Linz Gmbh ElisabethinenLinz, Austria, 4020 Lkh - UniversitÃ¤tsklinikum Der Pmu SalzburgSalzburg, Austria, 5020 Medical University Vienna, MuvVienna, Austria, A-1090|Aalst, Belgium, 9300 Zna MiddelheimAntwerpen, Belgium, 2020 Cliniques Universitaires Saint-LucBrussel, Belgium, 1200 Clinique Notre Dame De GrÃ¢ceCharleroi, Belgium, 6000 Az Maria MiddelaresGent, Belgium, 9000 Uz GentGent, Belgium, 9000 Chc-Cliniques Saint-JosephLiÃ¨ge, Belgium, 4000 Sint-Augustinus AzWilrijk, Belgium, 2610 Chu Dinant Godinne Ucl NamurYvoir, Belgium, 5530|Barretos, Brazil, 14784-400 AssociaÃ§Ã£o MÃ¡rio Penna/NÃºcleo De Ensino E PesquisasBelo Horizonte, Brazil, 30380-472 Hospital Erasto GaertnerCuritiba, Brazil, 81520-060 Hospital AraÃºjo Jorge Da AssociaÃ§Ã£o De Combate Ao CÃ¢ncer Em GoiÃ¡sGoiÃ¢nia, Brazil, 74605-070 ClÃ­nica De Neoplasias Litoral Ltda.Itajai, Brazil, 88301-220 Upco - HcpaPorto Alegre, Brazil, 90035-903 Inca - Instituto Nacional Do CancerRio De Janeiro, Brazil, 20231-050 OncoclÃ­nicasRio De Janeiro, Brazil, 22250-905 Fundacao Antonio PrudenteSao Paulo, Brazil, 01509900 Ibcc - Instituto Brasileiro De Controle Do CancerSao Paulo, Brazil Hospital De Base De SÃ£o JosÃ© Do Rio PretoSÃ£o JosÃ© Do Rio Preto, Brazil, 15090-000 Sociedade Beneficiante De Senhoras - Hospital Sirio LibanesSÃ£o Paulo, Brazil, 01308901 Instituto D'Or De Pesquisa E Ensino (Idor)SÃ£o Paulo, Brazil, 04502-001 Hospital Israelita Albert EinsteinSÃ£o Paulo, Brazil, 05651-900 Cepho - Faculdade De Medicina Do AbcSÃ£o Paulo, Brazil, 09060-650|Kelowna, British Columbia, Canada, V1Y 5L3 Vancouver Cancer CentreVancouver, British Columbia, Canada, V5Z 4E6|Winnipeg, Manitoba, Canada, R3E 0V9|Thunder Bay, Ontario, Canada, P7B 6V4 Princess Margaret Hospital- UhnToronto, Ontario, Canada, M5G 2M9|Regina, Saskatchewan, Canada, S4T 7T1|Beijing, China, 100021 Peking University First HospitalBeijing, China, 100034 Beijing Friendship HospitalBeijing, China, 100050 Peking University Third HospitalBeijing, China, 100191 Beijing HospitalBeijing, China, 100730 Peking Union Medical College HospitalBeijing, China, 100730 Sichuan Provincial People'S HospitalChengdu, China, 610000 Chongqing Medical UniversityChongqing, China, 400030 Sun Yat-Sen University Cancer CenterGuangzhou, China, 510060 Sun Yat-Sen Memorial Hospital, Sun Yat-Sen UniversityGuangzhou, China, 510120 Guangzhou First Municipal People'S HospitalGuangzhou, China, 510180 Zhejiang Provincial People'S HospitalHangzhou, China, 310014 Sir Run Run Shaw Hospital, Zhejiang UniversityHangzhou, China, 310020 The First Affliated Hospital Of Nanchang UniversityNanchang, China, 330006 Nanjing Drum Tower HospitalNanjing, China, 210008 Jiangsu Cancer HospitalNanjing, China, 210009 Renji Hospital, Shanghai Jiaotong University School Of MedicineShanghai, China, 200127 Huadong Hospital Affiliated To Fudan UniversityShanghai, China, 200400 Shengjing Hospital Of|Shenyang, China, 110004 Liaoning Cancer Hospital & InstituteShenyang, China, 110042 First Affiliated Hospital, Xi'An Jiaotong UniversityXi'An, China, 710061|Angers, France, 49055 Hopital Jean MinjozBesancon Cedex, France, 25030 Institut BergoniÃ©Bordeaux, France, 33000 Centre Jean PerrinClermont Ferrand, France, 63011 Centre Georges-FranÃ§ois LeclercDijon, France, 21079 Centre Oscar LambretLille, France, 59020 Centre Leon BÃ©rardLyon, France, 69008 Hopital De La TimoneMarseille, France, 13005 Institut Regional Du Cancer De Montpellier Val D'AurelleMontpellier, France, 34298 Centre Antoine LacassagneNice, France, 06189 Institut De CancÃ©rologie Du GardNÃ®mes, France, 30029 Hospital Saint-LouisParis Cedex 10, France, 75475 Hopital Europeen Georges-PompidouParis, France, 75015 Hospices Civils De Lyon HclPierre-"}},"Alaska|Arizona|California|Colorado|Florida|Georgia|Idaho|Illinois|Kentucky|Michigan|Nebraska|Nevada|New York|North Carolina|Pennsylvania|South Carolina|Texas|Virginia|Washington","Australia|Austria|Belgium|Brazil|Canada|China|France|Germany|Greece|Hungary|Israel|Italy|Japan|Mexico|Netherlands|Portugal|Spain|Turkey|Ukraine|United Kingdom|United States","Chris O'Brien Lifehouse|Lkh-Univ. Klinikum Graz|Olv Ziekenhuis Aalst|Fundacao Pio Xii - Hospital De Cancer De Barretos|British Columbia Bc Cancer Agency - Southern Interior|Manitoba Cancercare Manitoba|Ontario Thunder Bay Regional Health Sciences Centre|Saskatchewan Saskatchewan Cancer Agency (Sca) - Allan Blair Cancer Centre|Cancer Hospital Chinese Academy Of Medical Sciences|Medical University|Institut De CancÃ©rologie De L'Ouest (Ico)|Vivantes Klinikum Am Urban|University General Hospital Of Rio Patras|Semmelweis Egyetem|Rambam Health Care Campus|Azienda Ospedaliera Nazionale Ss. Antonio E Biagio E Cesare Arrigo Alessandria|Chiba Cancer Center|San Peregrino Cancer Center|St. Antonius Ziekenhuis Nieuwegein|Hospital LusÃ­adas|Hosp. Univ. Infanta Cristina|Baskent University Adana Practice And Research Center Kisla Health Campus|Based On Kyiv City Clinical Oncology Center|Chernivtsi Regional Clinical Hospital|University Hospitals Bristol - Bristol Haematology & Oncolog|Alaska Urological Institute Dba Alaska Clinical Research Center|University Of Ua Cancer Center(Uacc)/Dh-Sjhmc|University Of California Irvine Medical Center - Chao Family Comprehensive Cancer Center|Uchealth Anschutz Cancer Pavilion|University Of Miami/Sylvester Cancer Center|Piedmont Cancer Institute|St. Luke's Meridian Medical Center|Rush University|Norton Cancer Institute|University Of Michigan Health System|University Of Nebraska Medical Center|Va Sierra Nevada Health Care System|Montefiore Medical Center|Levine Cancer Institute, Carolinas Healthcare System|Penn State Hershey Cancer Institute|University Of Missouri|The Center For Cancer And Blood Disorders|Inova Dwiight &Martha Schar Cancer Institute|Va Puget Sound Healthcare System",{"$nulls":3},"Janssen Research & Development, LLC Clinical Trials","2020-01-09","2020-05-25T16:35:14.335","2020-05-26T17:10:42.972","NCT03390504"]
["5ecbf3c2e2561b1b11905c9c","NCT03390504","2020-02-06","Johnson & Johnson","JNJ","Recruiting","A Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Participants With Advanced Urothelial Cancer and Selected Fibroblast Growth Factor Receptor (FGFR) Gene Aberrations","Erdafitinib|Fibroblast|Vinflunine|Docetaxel|Pembrolizumab","FGFR Antagonist|Tubulin Inhibitor|Mitosis Inhibitor|Tubulin Inhibitor|PD-1 Inhibitor","Yes","['Fibroblast', 'Vinflunine']","No",null,"Phase 3",4,631,"Anticipated","2018-03-23","2020-11-24","OS","Overall Survival",{"$nulls":3},"The purpose of this study is to evaluate efficacy of erdafitinib versus chemotherapy or pembrolizumab in participants with advanced urothelial cancer harboring selected fibroblast growth factor receptor (FGFR) aberrations who have progressed after 1 or 2 prior treatments, at least 1 of which includes an anti-PD-(L) 1 agent (cohort 1) or 1 prior treatment not containing an anti-PD-(L) 1 agent (cohort 2).","A study of erdafitinib versus standard of care, consisting of chemotherapy (docetaxel or vinflunine) or anti-PD-(L) 1 agent pembrolizumab, in participants with advanced urothelial cancer and selected FGFR aberrations who have progressed on or after 1 or 2 prior treatments, at least 1 of which includes an anti-PD-(L) 1 agent (cohort 1) or 1 prior treatment not containing an anti-PD-(L) 1 agent (cohort 2). It will consist of screening, treatment phase (from randomization until disease progression, intolerable toxicity, withdrawal of consent or decision by investigator to discontinue treatment, post-treatment followup (from end-of-treatment to participants death, withdraws consent, lost to follow-up, or end of study, whichever comes first). Efficacy, pharmacokinetics, biomarkers, patient reported outcomes, medical resource utilization and safety will be assessed.","A Phase 3 Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Subjects With Advanced Urothelial Cancer and Selected FGFR Gene Aberrations","CR108401","Urothelial Cancer","Transitional Cell Carcinoma","Oncology Solid Tumor","Oncology","Experimental","Cohort 1 (Arm 1A): Erdafitinib|Cohort 1 (Arm 1B): Vinflunine or Docetaxel|Cohort 2 (Arm 2A): Erdafitinib|Cohort 2 (Arm 2B): Pembrolizumab","Participants will be screened based on Fibroblast Growth Factor Receptor inhibitor Clinical Trial Assay (FGFRi CTA) to determine molecular eligibility and participants who meet molecular eligibility criteria will be eligible for full study screening. Participants enrolled in the study (treated with prior anti-programmed cell death protein PD-[L] 1 agent) will swallow erdafitinib tablets orally at a starting dose of 8 milligram (mg), once daily for 21 days in a 21-day cycle until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustment are based on phosphate level and observed toxicity (adverse events [AEs]).|Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be eligible for full study screening. Participants enrolled in the study (treated with prior anti-PD-[L] 1 agent) will receive vinflunine 320 milligram per meter square (mg/m^2) as a 20-minute intravenous infusion once every 3 weeks or docetaxel 75 mg/m^2 as a 1 hour intravenous infusion every 3 weeks. Treatment with either agent (choice of investigator) will be administered until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustments are based on observed toxicities.|Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be eligible for full study screening. Participants enrolled in the study (no prior treatment with anti-PD-[L] 1 agent) will swallow erdafitinib tablets orally at a starting dose of 8 mg, once daily for 21 days in a 21-day cycle until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustments are based on phosphate level and observed toxicity (AEs).|Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be eligible for full study screening. Participants enrolled in the study (no prior treatment with anti-PD-[L] 1 agent) will receive pembrolizumab 200 mg as a 30-minute intravenous infusion once every 3 weeks, until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustments are based on observed toxicities.","Drug|Device","Erdafitinib|Fibroblast Growth Factor Receptor inhibitor Clinical Trial Assay (FGFRi CTA)|Vinflunine|Docetaxel|Pembrolizumab","Participants will swallow erdafitinib tablets orally at a starting dose of 8 mg.|FGFRi CTA will be used to determine molecular eligibility.|Participants will receive vinflunine 320 mg/m^2 as a 20-minute intravenous infusion.|Participants will receive docetaxel 75 mg/m^2 as a 1 hour intravenous infusion.|Participants will receive pembrolizumab 200 mg as a 30-minute intravenous infusion.","JNJ-42756493","Cohort 1 (Arm 1A): Erdafitinib|Cohort 1 (Arm 1B): Vinflunine or Docetaxel|Cohort 2 (Arm 2A): Erdafitinib|Cohort 2 (Arm 2B): Pembrolizumab","\n\n * Histologic demonstration of transitional cell carcinoma of the urothelium. Minor components ( less than [<] 50 percent [%] overall) of variant histology such as glandular or squamous differentiation, or evolution to more aggressive phenotypes such as sarcomatoid or micropapillary change are acceptable\n * Metastatic or surgically unresectable urothelial cancer\n * Documented progression of disease, defined as any progression that requires a change in treatment, prior to randomization\n * Cohort 1: Prior treatment with an anti-PD-(L) 1 agent as monotherapy or as combination therapy; no more than 2 prior lines of systemic treatment. Cohort 2: No prior treatment with an anti-PD-(L) 1 agent; only 1 line of prior systemic treatment. Subjects who received neoadjuvant or adjuvant chemotherapy and showed disease progression within 12 months of the last dose are considered to have received systemic therapy in the metastatic setting.\n * A woman of childbearing potential who is sexually active must have a negative pregnancy test (beta human chorionic gonadotropin [beta hCG]) at Screening (urine or serum)\n * Participants must meet appropriate molecular eligibility criteria\n * Eastern Cooperative Oncology Group (ECOG) performance status Grade 0, 1, or 2\n * Adequate bone marrow, liver, and renal function\n\n","\n\n * Treatment with any other investigational agent or participation in another clinical study with therapeutic intent within 30 days prior to randomization\n * Active malignancies (that is, requiring treatment change in the last 24 months). The only allowed exceptions are: urothelial cancer, skin cancer treated within the last 24 months that is considered completely cured, localized prostate cancer with a gleason score of 6 (treated within the last 24 months or untreated and under surveillance) and localized prostate cancer with a gleason score of 3+4 that has been treated more than 6 months prior to full study screening and considered to have a very low risk of recurrence.\n * Symptomatic central nervous system metastases\n * Received prior fibroblast growth factor receptor (FGFR) inhibitor treatment\n * Known allergies, hypersensitivity, or intolerance to erdafitinib or its excipients\n * Current central serous retinopathy (CSR) or retinal pigment epithelial detachment of any grade.\n * History of uncontrolled cardiovascular disease\n * Impaired wound healing capacity defined as skin/decubitus ulcers, chronic leg ulcers, known gastric ulcers, or unhealed incisions",{"$nulls":4},"Actual","2018-01-04","Actual","Anticipated","2021-11-05","Anticipated","2020-02-01","2017-12-20","2018-01-03","2020-02-05","Yes",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No",null,null,"URL: http://pam.sylogent.com/cr/CR108401 [http://pam.sylogent.com/cr/CR108401] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To learn how to participate in this trial please click here.",null,"Yes","Yes",{"$nulls":17},"2017-002932-18|42756493BLC3001","EudraCT Number|Janssen Research & Development, LLC","Overall Survival (OS)","Overall survival is measured from the date of randomization to the date of the participant's death. If the participant is alive or the vital status is unknown, the participant will be censored at the date the participant was last known to be alive.","Date of first randomization to the date of participant's death (approximately up to 3 years)","Progression-free Survival (PFS)|Overall Response Rate (ORR)|Time to Worsening in Symptom Items and Functioning Subscales in Patient-Reported Health Status of the Functional Assessment of Cancer Therapy-Bladder Cancer (FACT-Bl)|Change from Baseline in Patient-Global Impression of Severity (PGIS) Score|Change from Baseline in the Visual Analog Scale (VAS) of the EQ-5D-5L|Change from Baseline in the Utility Scale of the EQ-5D-5L|Duration of Response (DOR)|Number of Participants with Adverse Events (AEs) as a Measure of Safety|Oral Clearance (CL/F) of Erdafitinib|Area Under the Plasma Concentration-Time Curve from Time Zero to Time 't' (AUC[0-t]) of Erdafitinib","PFS is defined as duration in days from date of randomization to disease progression date (assessed per Response Evaluation Criteria in Solid Tumors Version 1.1|ORR is defined as the proportion of participants who achieve CR (CR; disappearance of all target lesions and disappearance of all non-target lesions and normalization of tumor marker level) or partial response (PR; at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters), as assessed per RECIST v1.1 by the investigator.|The FACT-Bl consists of 36 core items, with 5-point Likert response scales, covering 5 primary domains: Physical well-being, social/family well-being, emotional well-being, functional well-being and bladder symptom subscale. The answer scales range from \"Not at all (score=0)\" to \"very much (score=4)\" to assess the meaningful significant symptom deterioration.|The PGIS is a single question regarding the participant report of disease severity. Participants will be asked that ''considering all aspects of your bladder cancer symptoms right now, would you say your bladder cancer symptoms are none, mild, moderate, severe, or very severe?\" The PGIS is an anchor question that will be used to establish the magnitude of meaningful change in this study by assessing disease severity.|European Quality of Life 5 Dimensions (EQ-5D) visual analog scale (VAS) is a 20 centimeter (cm) vertical VAS with scores ranging from 0 (worst imaginable health) to 100 (perfect health). A higher score indicates an improvement in health in the Health Status Index.|The EuroQol-5 is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating \"full health\" and 0 representing dead.|DOR for responders is defined as duration in days from the date of initial documentation of a response to the date of first documented evidence of progressive disease (PD) or relapse for participants who experience CR (CR; disappearance of all target lesions and disappearance of all non-target lesions and normalization of tumor marker level) during the study or death.|An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.|CL/F is the oral clearance; that is clearance based on oral bioavailability of erdafitinib.|AUC(0-t) is the area under the plasma concentration-time curve from time zero to any time 't' of erdafitinib.","RECIST v1.1 by investigator) or relapse from CR or death, whichever is reported first. RECIST 1.1, progressive disease is defined as a 20 percent (%) increase in the sum of diameters of all target lesions and a minimum absolute increase of 5 millimeter (mm) in the sum. CR is defined as disappearance of all target lesions, non-target lesions and normalization of tumor marker level.|Approximately up to 3 years|Baseline up to end of treatment (approximately 3 years)|Baseline up to follow up phase (approximately 3 years)|From the date of initial documentation of a response to date of first documented evidence of progressive disease (or participants relapse who experience CR during the study) or death (approximately up to 3 years)|Day 14 (Cycle 1), Day 1 (Cycle 2) (each cycle is of 21 days)","JNJ.CT@sylogent.com","Study Contact","844-434-4210",{"$cut":{"chars":19078,"head":"Camperdown, Australia, 2050 Peninsula & South Eastern Haematology And Oncology GroupFrankston, Australia, 3199 Royal Hobart HospitalHobart, Australia, 7000 St George HospitalKogarah, Australia, 2217 Peter Maccallum Cancer CentreMelbourne, Australia, 3000 Frankston HospitalMelbourne, Australia, 3199 Fiona Stanley HospitalMurdoch, Australia, 6150|Graz, Austria, 8036 Ordensklinikum Linz Gmbh ElisabethinenLinz, Austria, 4020 Lkh - UniversitÃ¤tsklinikum Der Pmu SalzburgSalzburg, Austria, 5020 Medical University Vienna, MuvVienna, Austria, A-1090|Aalst, Belgium, 9300 Zna MiddelheimAntwerpen, Belgium, 2020 Cliniques Universitaires Saint-LucBrussel, Belgium, 1200 Clinique Notre Dame De GrÃ¢ceCharleroi, Belgium, 6000 Az Maria MiddelaresGent, Belgium, 9000 Uz GentGent, Belgium, 9000 Chc MontlegiaLiÃ¨ge, Belgium, 4000 Sint-Augustinus AzWilrijk, Belgium, 2610 Chu Ucl Namur - Site GodinneYvoir, Belgium, 5530|Barretos, Brazil, 14784-400 AssociaÃ§Ã£o MÃ¡rio Penna/NÃºcleo De Ensino E PesquisasBelo Horizonte, Brazil, 30380-472 Hospital Erasto GaertnerCuritiba, Brazil, 81520-060 Hospital AraÃºjo Jorge Da AssociaÃ§Ã£o De Combate Ao CÃ¢ncer Em GoiÃ¡sGoiÃ¢nia, Brazil, 74605-070 ClÃ­nica De Neoplasias Litoral Ltda.Itajai, Brazil, 88301-220 Upco - HcpaPorto Alegre, Brazil, 90035-903 Inca - Instituto Nacional Do CancerRio De Janeiro, Brazil, 20231-050 OncoclÃ­nicasRio De Janeiro, Brazil, 22250-905 Fundacao Antonio PrudenteSao Paulo, Brazil, 01509900 Ibcc - Instituto Brasileiro De Controle Do CancerSao Paulo, Brazil Hospital De Base De SÃ£o JosÃ© Do Rio PretoSÃ£o JosÃ© Do Rio Preto, Brazil, 15090-000 Sociedade Beneficiante De Senhoras - Hospital Sirio LibanesSÃ£o Paulo, Brazil, 01308901 Instituto D'Or De Pesquisa E Ensino (Idor)SÃ£o Paulo, Brazil, 04502-001 Hospital Israelita Albert EinsteinSÃ£o Paulo, Brazil, 05651-900 Cepho - Faculdade De Medicina Do AbcSÃ£o Paulo, Brazil, 09060-650|Kelowna, British Columbia, Canada, V1Y 5L3 Vancouver Cancer CentreVancouver, British Columbia, Canada, V5Z 4E6|Winnipeg, Manitoba, Canada, R3E 0V9|Thunder Bay, Ontario, Canada, P7B 6V4 Princess Margaret Hospital- UhnToronto, Ontario, Canada, M5G 2M9|Regina, Saskatchewan, Canada, S4T 7T1|Beijing, China, 100021 Peking University First HospitalBeijing, China, 100034 Beijing Friendship HospitalBeijing, China, 100050 Peking University Third HospitalBeijing, China, 100191 Beijing HospitalBeijing, China, 100730 Peking Union Medical College HospitalBeijing, China, 100730 Sichuan Provincial People'S HospitalChengdu, China, 610000 Chongqing Medical UniversityChongqing, China, 400030 Sun Yat-Sen University Cancer CenterGuangzhou, China, 510060 Sun Yat-Sen Memorial Hospital, Sun Yat-Sen UniversityGuangzhou, China, 510120 Guangzhou First Municipal People'S HospitalGuangzhou, China, 510180 Zhejiang Provincial People'S HospitalHangzhou, China, 310014 Sir Run Run Shaw Hospital, Zhejiang UniversityHangzhou, China, 310020 The First Affliated Hospital Of Nanchang UniversityNanchang, China, 330006 Nanjing Drum Tower HospitalNanjing, China, 210008 Jiangsu Cancer HospitalNanjing, China, 210009 Renji Hospital, Shanghai Jiaotong University School Of MedicineShanghai, China, 200127 Huadong Hospital Affiliated To Fudan UniversityShanghai, China, 200400 Shengjing Hospital Of|Shenyang, China, 110004 Liaoning Cancer Hospital & InstituteShenyang, China, 110042 First Affiliated Hospital, Xi'An Jiaotong UniversityXi'An, China, 710061|Angers, France, 49055 Hopital Jean MinjozBesancon Cedex, France, 25030 Institut BergoniÃ©Bordeaux, France, 33000 Centre Jean PerrinClermont Ferrand, France, 63011 Centre Georges-FranÃ§ois LeclercDijon, France, 21079 Centre Oscar LambretLille, France, 59020 Groupe Hospitalier Bretagne SudLorient, France, 56322 Centre Leon BÃ©rardLyon, France, 69008 Hopital De La TimoneMarseille, France, 13005 Institut Regional Du Cancer De Montpellier Val D'AurelleMontpellier, France, 34298 Centre Antoine LacassagneNice, France, 06189 Institut De CancÃ©rologie Du GardNÃ®mes, France, 30029 Hospital Saint-LouisParis Cedex 10, France, 75475 Hopital Europeen Georges-PompidouParis, France,"}},"Alaska|Arizona|California|Colorado|Florida|Georgia|Idaho|Illinois|Kentucky|Michigan|Nebraska|Nevada|New York|North Carolina|Pennsylvania|South Carolina|Texas|Virginia|Washington","Australia|Austria|Belgium|Brazil|Canada|China|France|Germany|Greece|Hungary|Israel|Italy|Japan|Mexico|Netherlands|Portugal|Spain|Turkey|Ukraine|United Kingdom|United States","Chris O'Brien Lifehouse|Lkh-Univ. Klinikum Graz|Olv Ziekenhuis Aalst|Fundacao Pio Xii - Hospital De Cancer De Barretos|British Columbia Bc Cancer Agency - Southern Interior|Manitoba Cancercare Manitoba|Ontario Thunder Bay Regional Health Sciences Centre|Saskatchewan Saskatchewan Cancer Agency (Sca) - Allan Blair Cancer Centre|Cancer Hospital Chinese Academy Of Medical Sciences|Medical University|Institut De CancÃ©rologie De L'Ouest (Ico)|Vivantes Klinikum Am Urban|University General Hospital Of Rio Patras|Semmelweis Egyetem|Rambam Health Care Campus|Azienda Ospedaliera Nazionale Ss. Antonio E Biagio E Cesare Arrigo Alessandria|Chiba Cancer Center|San Peregrino Cancer Center|St. Antonius Ziekenhuis Nieuwegein|Hospital LusÃ­adas|Hosp. Univ. Infanta Cristina|Baskent University Adana Practice And Research Center Kisla Health Campus|Based On Kyiv City Clinical Oncology Center|Chernivtsi Regional Clinical Hospital|University Hospitals Bristol - Bristol Haematology & Oncolog|Alaska Urological Institute Dba Alaska Clinical Research Center|University Of Ua Cancer Center(Uacc)/Dh-Sjhmc|University Of California Irvine Medical Center - Chao Family Comprehensive Cancer Center|Uchealth Anschutz Cancer Pavilion|University Of Miami/Sylvester Cancer Center|Piedmont Cancer Institute|St. Luke's Meridian Medical Center|Rush University|Norton Cancer Institute|University Of Michigan Health System|University Of Nebraska Medical Center|Va Sierra Nevada Health Care System|Montefiore Medical Center|Levine Cancer Institute, Carolinas Healthcare System|Penn State Hershey Cancer Institute|University Of Missouri|The Center For Cancer And Blood Disorders|Inova Dwiight &Martha Schar Cancer Institute|Va Puget Sound Healthcare System",{"$nulls":3},"Janssen Research & Development, LLC Clinical Trials","2020-02-05","2020-05-25T16:35:14.446","2020-05-26T17:10:42.972","NCT03390504"]
["5ecbf3c2e2561b1b11905c9d","NCT03390504","2020-03-06","Johnson & Johnson","JNJ","Recruiting","A Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Participants With Advanced Urothelial Cancer and Selected Fibroblast Growth Factor Receptor (FGFR) Gene Aberrations","Erdafitinib|Fibroblast|Vinflunine|Docetaxel|Pembrolizumab","FGFR Antagonist|Tubulin Inhibitor|Mitosis Inhibitor|Tubulin Inhibitor|PD-1 Inhibitor","Yes","['Fibroblast', 'Vinflunine']","No",null,"Phase 3",4,631,"Anticipated","2018-03-23","2020-11-24","OS","Overall Survival",{"$nulls":3},"The purpose of this study is to evaluate efficacy of erdafitinib versus chemotherapy or pembrolizumab in participants with advanced urothelial cancer harboring selected fibroblast growth factor receptor (FGFR) aberrations who have progressed after 1 or 2 prior treatments, at least 1 of which includes an anti-PD-(L) 1 agent (cohort 1) or 1 prior treatment not containing an anti-PD-(L) 1 agent (cohort 2).","A study of erdafitinib versus standard of care, consisting of chemotherapy (docetaxel or vinflunine) or anti-PD-(L) 1 agent pembrolizumab, in participants with advanced urothelial cancer and selected FGFR aberrations who have progressed on or after 1 or 2 prior treatments, at least 1 of which includes an anti-PD-(L) 1 agent (cohort 1) or 1 prior treatment not containing an anti-PD-(L) 1 agent (cohort 2). It will consist of screening, treatment phase (from randomization until disease progression, intolerable toxicity, withdrawal of consent or decision by investigator to discontinue treatment, post-treatment followup (from end-of-treatment to participants death, withdraws consent, lost to follow-up, or end of study, whichever comes first). Efficacy, pharmacokinetics, biomarkers, patient reported outcomes, medical resource utilization and safety will be assessed.","A Phase 3 Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Subjects With Advanced Urothelial Cancer and Selected FGFR Gene Aberrations","CR108401","Urothelial Cancer","Transitional Cell Carcinoma","Oncology Solid Tumor","Oncology","Experimental","Cohort 1 (Arm 1A): Erdafitinib|Cohort 1 (Arm 1B): Vinflunine or Docetaxel|Cohort 2 (Arm 2A): Erdafitinib|Cohort 2 (Arm 2B): Pembrolizumab","Participants will be screened based on Fibroblast Growth Factor Receptor inhibitor Clinical Trial Assay (FGFRi CTA) to determine molecular eligibility and participants who meet molecular eligibility criteria will be eligible for full study screening. Participants enrolled in the study (treated with prior anti-programmed cell death protein PD-[L] 1 agent) will swallow erdafitinib tablets orally at a starting dose of 8 milligram (mg), once daily for 21 days in a 21-day cycle until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustment are based on phosphate level and observed toxicity (adverse events [AEs]).|Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be eligible for full study screening. Participants enrolled in the study (treated with prior anti-PD-[L] 1 agent) will receive vinflunine 320 milligram per meter square (mg/m^2) as a 20-minute intravenous infusion once every 3 weeks or docetaxel 75 mg/m^2 as a 1 hour intravenous infusion every 3 weeks. Treatment with either agent (choice of investigator) will be administered until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustments are based on observed toxicities.|Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be eligible for full study screening. Participants enrolled in the study (no prior treatment with anti-PD-[L] 1 agent) will swallow erdafitinib tablets orally at a starting dose of 8 mg, once daily for 21 days in a 21-day cycle until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustments are based on phosphate level and observed toxicity (AEs).|Participants will be screened based on FGFRi CTA to determine molecular eligibility and participants who meet molecular eligibility criteria will be eligible for full study screening. Participants enrolled in the study (no prior treatment with anti-PD-[L] 1 agent) will receive pembrolizumab 200 mg as a 30-minute intravenous infusion once every 3 weeks, until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustments are based on observed toxicities.","Drug|Device","Erdafitinib|Fibroblast Growth Factor Receptor inhibitor Clinical Trial Assay (FGFRi CTA)|Vinflunine|Docetaxel|Pembrolizumab","Participants will swallow erdafitinib tablets orally at a starting dose of 8 mg.|FGFRi CTA will be used to determine molecular eligibility.|Participants will receive vinflunine 320 mg/m^2 as a 20-minute intravenous infusion.|Participants will receive docetaxel 75 mg/m^2 as a 1 hour intravenous infusion.|Participants will receive pembrolizumab 200 mg as a 30-minute intravenous infusion.","JNJ-42756493","Cohort 1 (Arm 1A): Erdafitinib|Cohort 1 (Arm 1B): Vinflunine or Docetaxel|Cohort 2 (Arm 2A): Erdafitinib|Cohort 2 (Arm 2B): Pembrolizumab","\n\n * Histologic demonstration of transitional cell carcinoma of the urothelium. Minor components ( less than [<] 50 percent [%] overall) of variant histology such as glandular or squamous differentiation, or evolution to more aggressive phenotypes such as sarcomatoid or micropapillary change are acceptable\n * Metastatic or surgically unresectable urothelial cancer\n * Documented progression of disease, defined as any progression that requires a change in treatment, prior to randomization\n * Cohort 1: Prior treatment with an anti-PD-(L) 1 agent as monotherapy or as combination therapy; no more than 2 prior lines of systemic treatment. Cohort 2: No prior treatment with an anti-PD-(L) 1 agent; only 1 line of prior systemic treatment. Subjects who received neoadjuvant or adjuvant chemotherapy and showed disease progression within 12 months of the last dose are considered to have received systemic therapy in the metastatic setting.\n * A woman of childbearing potential who is sexually active must have a negative pregnancy test (beta human chorionic gonadotropin [beta hCG]) at Screening (urine or serum)\n * Participants must meet appropriate molecular eligibility criteria\n * Eastern Cooperative Oncology Group (ECOG) performance status Grade 0, 1, or 2\n * Adequate bone marrow, liver, and renal function\n\n","\n\n * Treatment with any other investigational agent or participation in another clinical study with therapeutic intent within 30 days prior to randomization\n * Active malignancies (that is, requiring treatment change in the last 24 months). The only allowed exceptions are: urothelial cancer, skin cancer treated within the last 24 months that is considered completely cured, localized prostate cancer with a gleason score of 6 (treated within the last 24 months or untreated and under surveillance) and localized prostate cancer with a gleason score of 3+4 that has been treated more than 6 months prior to full study screening and considered to have a very low risk of recurrence.\n * Symptomatic central nervous system metastases\n * Received prior fibroblast growth factor receptor (FGFR) inhibitor treatment\n * Known allergies, hypersensitivity, or intolerance to erdafitinib or its excipients\n * Current central serous retinopathy (CSR) or retinal pigment epithelial detachment of any grade.\n * History of uncontrolled cardiovascular disease\n * Impaired wound healing capacity defined as skin/decubitus ulcers, chronic leg ulcers, known gastric ulcers, or unhealed incisions",{"$nulls":4},"Actual","2018-01-04","Actual","Anticipated","2021-11-05","Anticipated","2020-03-01","2017-12-20","2018-01-03","2020-03-05","Yes",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No",null,null,"URL: http://pam.sylogent.com/cr/CR108401 [http://pam.sylogent.com/cr/CR108401] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To learn how to participate in this trial please click here.",null,"Yes","Yes",{"$nulls":17},"2017-002932-18|42756493BLC3001","EudraCT Number|Janssen Research & Development, LLC","Overall Survival (OS)","Overall survival is measured from the date of randomization to the date of the participant's death. If the participant is alive or the vital status is unknown, the participant will be censored at the date the participant was last known to be alive.","Date of first randomization to the date of participant's death (approximately up to 3 years)","Progression-free Survival (PFS)|Overall Response Rate (ORR)|Time to Worsening in Symptom Items and Functioning Subscales in Patient-Reported Health Status of the Functional Assessment of Cancer Therapy-Bladder Cancer (FACT-Bl)|Change from Baseline in Patient-Global Impression of Severity (PGIS) Score|Change from Baseline in the Visual Analog Scale (VAS) of the EQ-5D-5L|Change from Baseline in the Utility Scale of the EQ-5D-5L|Duration of Response (DOR)|Number of Participants with Adverse Events (AEs) as a Measure of Safety|Oral Clearance (CL/F) of Erdafitinib|Area Under the Plasma Concentration-Time Curve from Time Zero to Time 't' (AUC[0-t]) of Erdafitinib","PFS is defined as duration in days from date of randomization to disease progression date (assessed per Response Evaluation Criteria in Solid Tumors Version 1.1|ORR is defined as the proportion of participants who achieve CR (CR; disappearance of all target lesions and disappearance of all non-target lesions and normalization of tumor marker level) or partial response (PR; at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters), as assessed per RECIST v1.1 by the investigator.|The FACT-Bl consists of 36 core items, with 5-point Likert response scales, covering 5 primary domains: Physical well-being, social/family well-being, emotional well-being, functional well-being and bladder symptom subscale. The answer scales range from \"Not at all (score=0)\" to \"very much (score=4)\" to assess the meaningful significant symptom deterioration.|The PGIS is a single question regarding the participant report of disease severity. Participants will be asked that ''considering all aspects of your bladder cancer symptoms right now, would you say your bladder cancer symptoms are none, mild, moderate, severe, or very severe?\" The PGIS is an anchor question that will be used to establish the magnitude of meaningful change in this study by assessing disease severity.|European Quality of Life 5 Dimensions (EQ-5D) visual analog scale (VAS) is a 20 centimeter (cm) vertical VAS with scores ranging from 0 (worst imaginable health) to 100 (perfect health). A higher score indicates an improvement in health in the Health Status Index.|The EuroQol-5 is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating \"full health\" and 0 representing dead.|DOR for responders is defined as duration in days from the date of initial documentation of a response to the date of first documented evidence of progressive disease (PD) or relapse for participants who experience CR (CR; disappearance of all target lesions and disappearance of all non-target lesions and normalization of tumor marker level) during the study or death.|An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.|CL/F is the oral clearance; that is clearance based on oral bioavailability of erdafitinib.|AUC(0-t) is the area under the plasma concentration-time curve from time zero to any time 't' of erdafitinib.","RECIST v1.1 by investigator) or relapse from CR or death, whichever is reported first. RECIST 1.1, progressive disease is defined as a 20 percent (%) increase in the sum of diameters of all target lesions and a minimum absolute increase of 5 millimeter (mm) in the sum. CR is defined as disappearance of all target lesions, non-target lesions and normalization of tumor marker level.|Approximately up to 3 years|Baseline up to end of treatment (approximately 3 years)|Baseline up to follow up phase (approximately 3 years)|From the date of initial documentation of a response to date of first documented evidence of progressive disease (or participants relapse who experience CR during the study) or death (approximately up to 3 years)|Day 14 (Cycle 1), Day 1 (Cycle 2) (each cycle is of 21 days)","JNJ.CT@sylogent.com","Study Contact","844-434-4210",{"$cut":{"chars":19277,"head":"Camperdown, Australia, 2050 Peninsula & South Eastern Haematology And Oncology GroupFrankston, Australia, 3199 Royal Hobart HospitalHobart, Australia, 7000 St George HospitalKogarah, Australia, 2217 Peter Maccallum Cancer CentreMelbourne, Australia, 3000 Frankston HospitalMelbourne, Australia, 3199 Fiona Stanley HospitalMurdoch, Australia, 6150|Graz, Austria, 8036 Ordensklinikum Linz Gmbh ElisabethinenLinz, Austria, 4020 Lkh - UniversitÃ¤tsklinikum Der Pmu SalzburgSalzburg, Austria, 5020 Medical University Vienna, MuvVienna, Austria, A-1090|Aalst, Belgium, 9300 Zna MiddelheimAntwerpen, Belgium, 2020 Cliniques Universitaires Saint-LucBrussel, Belgium, 1200 Clinique Notre Dame De GrÃ¢ceCharleroi, Belgium, 6000 Az Maria MiddelaresGent, Belgium, 9000 Uz GentGent, Belgium, 9000 Chc MontlegiaLiÃ¨ge, Belgium, 4000 Sint-Augustinus AzWilrijk, Belgium, 2610 Chu Ucl Namur - Site GodinneYvoir, Belgium, 5530|Barretos, Brazil, 14784-400 AssociaÃ§Ã£o MÃ¡rio Penna/NÃºcleo De Ensino E PesquisasBelo Horizonte, Brazil, 30380-472 Hospital Erasto GaertnerCuritiba, Brazil, 81520-060 Hospital AraÃºjo Jorge Da AssociaÃ§Ã£o De Combate Ao CÃ¢ncer Em GoiÃ¡sGoiÃ¢nia, Brazil, 74605-070 ClÃ­nica De Neoplasias Litoral Ltda.Itajai, Brazil, 88301-220 Upco - HcpaPorto Alegre, Brazil, 90035-903 Inca - Instituto Nacional Do CancerRio De Janeiro, Brazil, 20231-050 OncoclÃ­nicasRio De Janeiro, Brazil, 22250-905 Fundacao Antonio PrudenteSao Paulo, Brazil, 01509900 Ibcc - Instituto Brasileiro De Controle Do CancerSao Paulo, Brazil Hospital De Base De SÃ£o JosÃ© Do Rio PretoSÃ£o JosÃ© Do Rio Preto, Brazil, 15090-000 Sociedade Beneficiante De Senhoras - Hospital Sirio LibanesSÃ£o Paulo, Brazil, 01308901 Instituto D'Or De Pesquisa E Ensino (Idor)SÃ£o Paulo, Brazil, 04502-001 Hospital Israelita Albert EinsteinSÃ£o Paulo, Brazil, 05651-900 Cepho - Faculdade De Medicina Do AbcSÃ£o Paulo, Brazil, 09060-650|Kelowna, British Columbia, Canada, V1Y 5L3 Vancouver Cancer CentreVancouver, British Columbia, Canada, V5Z 4E6|Winnipeg, Manitoba, Canada, R3E 0V9|Thunder Bay, Ontario, Canada, P7B 6V4 Princess Margaret Hospital- UhnToronto, Ontario, Canada, M5G 2M9|Regina, Saskatchewan, Canada, S4T 7T1|Beijing, China, 100021 Peking University First HospitalBeijing, China, 100034 Beijing Friendship HospitalBeijing, China, 100050 Peking University Third HospitalBeijing, China, 100191 Beijing HospitalBeijing, China, 100730 Peking Union Medical College HospitalBeijing, China, 100730 Sichuan Provincial People'S HospitalChengdu, China, 610000 Sichuan University Huaxi HospitalChengdu, China, 610041 Chongqing Medical UniversityChongqing, China, 400030 Sun Yat-Sen University Cancer CenterGuangzhou, China, 510060 Sun Yat-Sen Memorial Hospital, Sun Yat-Sen UniversityGuangzhou, China, 510120 Guangzhou First Municipal People'S HospitalGuangzhou, China, 510180 Zhejiang Provincial People'S HospitalHangzhou, China, 310014 Sir Run Run Shaw Hospital, Zhejiang UniversityHangzhou, China, 310020 The First Affliated Hospital Of Nanchang UniversityNanchang, China, 330006 Nanjing Drum Tower HospitalNanjing, China, 210008 Jiangsu Cancer HospitalNanjing, China, 210009 Renji Hospital, Shanghai Jiaotong University School Of MedicineShanghai, China, 200127 Huadong Hospital Affiliated To Fudan UniversityShanghai, China, 200400 Shengjing Hospital Of|Shenyang, China, 110004 Liaoning Cancer Hospital & InstituteShenyang, China, 110042 First Affiliated Hospital, Xi'An Jiaotong UniversityXi'An, China, 710061|Angers, France, 49055 Hopital Jean MinjozBesancon Cedex, France, 25030 Institut BergoniÃ©Bordeaux, France, 33000 Centre Jean PerrinClermont Ferrand, France, 63011 Centre Georges-FranÃ§ois LeclercDijon, France, 21079 Centre Oscar LambretLille, France, 59020 Groupe Hospitalier Bretagne SudLorient, France, 56322 Centre Leon BÃ©rardLyon, France, 69008 Hopital De La TimoneMarseille, France, 13005 Institut Regional Du Cancer De Montpellier Val D'AurelleMontpellier, France, 34298 Centre Antoine LacassagneNice, France, 06189 Institut De CancÃ©rologie Du GardNÃ®mes, France, 30029 Hospital Saint-LouisParis Cedex 10, Franc"}},"Alaska|Arizona|California|Colorado|Florida|Georgia|Idaho|Illinois|Kentucky|Michigan|Nebraska|Nevada|New York|North Carolina|Pennsylvania|South Carolina|Texas|Virginia|Washington","Australia|Austria|Belgium|Brazil|Canada|China|France|Germany|Greece|Hungary|Israel|Italy|Japan|Mexico|Netherlands|Portugal|Spain|Turkey|Ukraine|United Kingdom|United States","Chris O'Brien Lifehouse|Lkh-Univ. Klinikum Graz|Olv Ziekenhuis Aalst|Fundacao Pio Xii - Hospital De Cancer De Barretos|British Columbia Bc Cancer Agency - Southern Interior|Manitoba Cancercare Manitoba|Ontario Thunder Bay Regional Health Sciences Centre|Saskatchewan Saskatchewan Cancer Agency (Sca) - Allan Blair Cancer Centre|Cancer Hospital Chinese Academy Of Medical Sciences|Medical University|Institut De CancÃ©rologie De L'Ouest (Ico)|Vivantes Klinikum Am Urban|University General Hospital Of Rio Patras|Semmelweis Egyetem|Rambam Health Care Campus|Azienda Ospedaliera Nazionale Ss. Antonio E Biagio E Cesare Arrigo Alessandria|Chiba Cancer Center|San Peregrino Cancer Center|St. Antonius Ziekenhuis Nieuwegein|Hospital LusÃ­adas|Hosp. Univ. Infanta Cristina|Baskent University Adana Practice And Research Center Kisla Health Campus|Based On Kyiv City Clinical Oncology Center|Chernivtsi Regional Clinical Hospital|University Hospitals Bristol - Bristol Haematology & Oncolog|Alaska Urological Institute Dba Alaska Clinical Research Center|University Of Ua Cancer Center(Uacc)/Dh-Sjhmc|University Of California Irvine Medical Center - Chao Family Comprehensive Cancer Center|Uchealth Anschutz Cancer Pavilion|University Of Miami/Sylvester Cancer Center|Piedmont Cancer Institute|St. Luke's Meridian Medical Center|Rush University|Norton Cancer Institute|University Of Michigan Health System|University Of Nebraska Medical Center|Va Sierra Nevada Health Care System|Montefiore Medical Center|Levine Cancer Institute, Carolinas Healthcare System|Penn State Hershey Cancer Institute|University Of Missouri|The Center For Cancer And Blood Disorders|Inova Dwiight &Martha Schar Cancer Institute|Va Puget Sound Healthcare System",{"$nulls":3},"Janssen Research & Development, LLC Clinical Trials","2020-03-05","2020-05-25T16:35:14.844","2020-05-26T17:10:42.972","NCT03390504"]
["5ecbf3c3e2561b1b11905c9f","NCT03390842","2018-01-04","Tricida","TCDA","Recruiting","Long-term Safety Extension to Study TRCA-301","Trc-101",null,"Yes","['Trc-101']","Unknown",null,"Phase 3",2,210,"Anticipated","2017-12-20","2019-02-01",{"$nulls":5},"This study is a 40-week, blinded, placebo-controlled extension of Study TRCA-301 (NCT03317444). Eligible subjects who complete the 12-week treatment period in Study TRCA-301 have the option to participate in this extension study evaluating the long-term safety and durability of effect of TRC101 in subjects with non-dialysis dependent chronic kidney disease and metabolic acidosis. Eligible subjects will be treated with TRC101 or placebo once daily (QD) on an out-patient basis for the subsequent 40 weeks. Subjects will continue to receive the same blinded treatment (TRC101 or placebo) that they received in Study TRCA-301.",null,"A Blinded, Placebo-Controlled Extension to Study TRCA-301 to Evaluate the Long-term Safety and Durability of Effect of TRC101 in Subjects With Chronic Kidney Disease and Metabolic Acidosis","TRCA-301E","Metabolic Acidosis","Acidosis","Metabolic Diseases","Nutritional Disorders","Experimental|Placebo Comparator","TRC101|Placebo","Administered once daily (QD) for 40 weeks","Drug","TRC101|Placebo","Oral suspension",null,"TRC101|Placebo","\n\n * Completed the 12-week treatment period and attended the Week 12 Visit in the parent study TRCA-301.\n * Blood bicarbonate level of >= 12 mEq/L at the Week 12 Visit in the parent study TRCA-301.\n\nKey ","\n\n * Any level of low blood bicarbonate at the Week 12 Visit that, in the opinion of the Investigator, requires emergency intervention or evaluation for an acute acidotic process.\n * Required dialysis for acute kidney injury or worsening CKD during the parent study TRCA-301.\n * Planned initiation of renal replacement therapy within 6 months following study entry.\n * History or current diagnosis of diabetic gastroparesis, bowel obstruction, swallowing disorders, severe gastrointestinal disorders, inflammatory bowel disease, major gastrointestinal surgery, or active gastric/duodenal ulcers.\n * Serum calcium <= 8.0 mg/dL at the Week 10 in the parent study TRCA-301.",{"$nulls":4},"Actual","2018-01-04","Actual","Anticipated","2019-02-01","Anticipated","2017-12-01","2017-12-28","2017-12-28","2017-12-28","Yes","blood bicarbonate, kidney disease","Interventional","Treatment","Parallel Assignment","Triple (Participant, Care Provider, Investigator)","Randomized","18 Years","85 Years","All",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":19},"Incidence of adverse events (AEs), serious adverse events (SAEs), and AEs leading to withdrawal.","Safety.","From Week 12 (enrollment) to Week 54 (last follow-up visit).","Change from baseline in blood bicarbonate.","Efficacy.","Week 52 (end of treatment)","ystasiv@tricida.com","Yuri Stasiv, PhD","415-429-7800","Sofia, Bulgaria|Tbilisi, Georgia|Chula Vista, California, United States, 91910|Hialeah, Florida, United States, 33015|Atlanta, Georgia, United States, 30342|San Antonio, Texas, United States, 78215","California|Florida|Georgia|Texas","Bulgaria|Georgia|United States","Investigative Site 11|Investigative Site 31|Investigative Site 56|Investigative Site 59|Investigative Site 95|Investigative Site 52",{"$nulls":4},"2017-12-28","2020-05-25T16:35:15.703","2020-05-26T17:10:42.972","NCT03390842"]
["5ecbf3c3e2561b1b11905c9e","NCT03390842","2018-03-30","Tricida","TCDA","Recruiting","Long-term Safety Extension to Study TRCA-301","Trc-101",null,"Yes","['Trc-101']","Unknown",null,"Phase 3",2,210,"Anticipated","2017-12-20","2019-02-01",{"$nulls":5},"This study is a 40-week, blinded, placebo-controlled extension of Study TRCA-301 (NCT03317444). Eligible subjects who complete the 12-week treatment period in Study TRCA-301 have the option to participate in this extension study evaluating the long-term safety and durability of effect of TRC101 in subjects with non-dialysis dependent chronic kidney disease and metabolic acidosis. Eligible subjects will be treated with TRC101 or placebo once daily (QD) on an out-patient basis for the subsequent 40 weeks. Subjects will continue to receive the same blinded treatment (TRC101 or placebo) that they received in Study TRCA-301.",null,"A Blinded, Placebo-Controlled Extension to Study TRCA-301 to Evaluate the Long-term Safety and Durability of Effect of TRC101 in Subjects With Chronic Kidney Disease and Metabolic Acidosis","TRCA-301E","Metabolic Acidosis","Acidosis","Metabolic Diseases","Nutritional Disorders","Experimental|Placebo Comparator","TRC101|Placebo","Administered once daily (QD) for 40 weeks","Drug","TRC101|Placebo","Oral suspension",null,"TRC101|Placebo","\n\n * Completed the 12-week treatment period and attended the Week 12 Visit in the parent study TRCA-301.\n * Blood bicarbonate level of >= 12 mEq/L at the Week 12 Visit in the parent study TRCA-301.\n\nKey ","\n\n * Any level of low blood bicarbonate at the Week 12 Visit that, in the opinion of the Investigator, requires emergency intervention or evaluation for an acute acidotic process.\n * Required dialysis for acute kidney injury or worsening CKD during the parent study TRCA-301.\n * Planned initiation of renal replacement therapy within 6 months following study entry.\n * History or current diagnosis of diabetic gastroparesis, bowel obstruction, swallowing disorders, severe gastrointestinal disorders, inflammatory bowel disease, major gastrointestinal surgery, or active gastric/duodenal ulcers.\n * Serum calcium <= 8.0 mg/dL at the Week 10 in the parent study TRCA-301.",{"$nulls":4},"Actual","2018-01-04","Actual","Anticipated","2019-02-01","Anticipated","2018-03-01","2017-12-28","2017-12-28","2018-03-29","Yes","blood bicarbonate, kidney disease","Interventional","Treatment","Parallel Assignment","Triple (Participant, Care Provider, Investigator)","Randomized","18 Years","85 Years","All",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":19},"Incidence of adverse events (AEs), serious adverse events (SAEs), and AEs leading to withdrawal.","Safety.","From Week 12 (enrollment) to Week 54 (last follow-up visit).","Change from baseline in blood bicarbonate.","Efficacy.","Week 52 (end of treatment)","ystasiv@tricida.com","Yuri Stasiv, PhD","415-429-7800","Sofia, Bulgaria|Tbilisi, Georgia|Budapest, Hungary|Kharkiv, Ukraine|Chula Vista, California, United States, 91910|Hialeah, Florida, United States, 33015|Atlanta, Georgia, United States, 30342|San Antonio, Texas, United States, 78215","California|Florida|Georgia|Texas","Bulgaria|Georgia|Hungary|Ukraine|United States","Investigative Site 11|Investigative Site 31|Investigative Site 41|Investigative Site 81|Investigative Site 56|Investigative Site 59|Investigative Site 95|Investigative Site 52",{"$nulls":4},"2018-03-29","2020-05-25T16:35:15.376","2020-05-26T17:10:42.972","NCT03390842"]
["5ecbf3c3fe30261b1a0481a3","NCT03390842","2018-05-07","Tricida","TCDA","Active, not recruiting","Long-term Safety Extension to Study TRCA-301","Trc-101",null,"Yes","['Trc-101']","Unknown",null,"Phase 3",2,196,"Actual","2017-12-20","2019-02-01",{"$nulls":5},"This study is a 40-week, blinded, placebo-controlled extension of Study TRCA-301 (NCT03317444). Eligible subjects who complete the 12-week treatment period in Study TRCA-301 have the option to participate in this extension study evaluating the long-term safety and durability of effect of TRC101 in subjects with non-dialysis dependent chronic kidney disease and metabolic acidosis. Eligible subjects will be treated with TRC101 or placebo once daily (QD) on an out-patient basis for the subsequent 40 weeks. Subjects will continue to receive the same blinded treatment (TRC101 or placebo) that they received in Study TRCA-301.",null,"A Blinded, Placebo-Controlled Extension to Study TRCA-301 to Evaluate the Long-term Safety and Durability of Effect of TRC101 in Subjects With Chronic Kidney Disease and Metabolic Acidosis","TRCA-301E","Metabolic Acidosis","Acidosis","Metabolic Diseases","Nutritional Disorders","Experimental|Placebo Comparator","TRC101|Placebo","Administered once daily (QD) for 40 weeks","Drug","TRC101|Placebo","Oral suspension",null,"TRC101|Placebo","\n\n * Completed the 12-week treatment period and attended the Week 12 Visit in the parent study TRCA-301.\n * Blood bicarbonate level of >= 12 mEq/L at the Week 12 Visit in the parent study TRCA-301.\n\nKey ","\n\n * Any level of low blood bicarbonate at the Week 12 Visit that, in the opinion of the Investigator, requires emergency intervention or evaluation for an acute acidotic process.\n * Required dialysis for acute kidney injury or worsening CKD during the parent study TRCA-301.\n * Planned initiation of renal replacement therapy within 6 months following study entry.\n * History or current diagnosis of diabetic gastroparesis, bowel obstruction, swallowing disorders, severe gastrointestinal disorders, inflammatory bowel disease, major gastrointestinal surgery, or active gastric/duodenal ulcers.\n * Serum calcium <= 8.0 mg/dL at the Week 10 in the parent study TRCA-301.",{"$nulls":4},"Actual","2018-01-04","Actual","Anticipated","2019-02-01","Anticipated","2018-05-01","2017-12-28","2017-12-28","2018-05-04","Yes","blood bicarbonate, kidney disease","Interventional","Treatment","Parallel Assignment","Triple (Participant, Care Provider, Investigator)","Randomized","18 Years","85 Years","All",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":19},"Incidence of adverse events (AEs), serious adverse events (SAEs), and AEs leading to withdrawal.","Safety.","From Week 12 (enrollment) to Week 54 (last follow-up visit).","Change from baseline in blood bicarbonate.","Efficacy.","Week 52 (end of treatment)",{"$nulls":3},"Sofia, Bulgaria|Tbilisi, Georgia Investigative Site 32Tbilisi, Georgia Investigative Site 33Tbilisi, Georgia Investigative Site 34Tbilisi, Georgia Investigative Site 35Tbilisi, Georgia Investigative Site 36Tbilisi, Georgia Investigative Site 37Tbilisi, Georgia|Budapest, Hungary Investigative Site 46Budapest, Hungary Investigative Site 49HÃ³dmezÅ‘vÃ¡sÃ¡rhely, Hungary Investigative Site 44Kistarcsa, Hungary|VrÅ¡ac, Serbia|Jesenice, Slovenia Investigative Site 71Maribor, Slovenia|Kharkiv, Ukraine Investigative Site 83Kharkiv, Ukraine Investigative Site 87Kharkiv, Ukraine Investigative Site 88Kharkiv, Ukraine Investigative Site 84Kyiv, Ukraine Investigative Site 85Kyiv, Ukraine Investigative Site 86Kyiv, Ukraine|Phoenix, Arizona, United States, 85032|Los Angeles, California, United States, 90022|Hialeah, Florida, United States, 33015 Investigative Site 93Hollywood, Florida, United States, 33024 Investigative Site 92Lauderdale Lakes, Florida, United States, 33313|Atlanta, Georgia, United States, 30342|San Antonio, Texas, United States, 78215","Arizona|California|Florida|Georgia|Texas","Bulgaria|Georgia|Hungary|Serbia|Slovenia|Ukraine|United States","Investigative Site 11|Investigative Site 31|Investigative Site 41|Investigative Site 61|Investigative Site 72|Investigative Site 81|Investigative Site 55|Investigative Site 91|Investigative Site 59|Investigative Site 95|Investigative Site 52",{"$nulls":4},"2018-05-04","2020-05-25T16:35:15.566","2020-05-26T17:10:42.972","NCT03390842"]
["5ecbf3c3feab101b155307d3","NCT03390842","2019-03-13","Tricida","TCDA","Completed","Long-term Safety Extension to Study TRCA-301","Trc-101",null,"Yes","['Trc-101']","Unknown",null,"Phase 3",2,196,"Actual","2017-12-20","2019-02-22",{"$nulls":5},"This study is a 40-week, blinded, placebo-controlled extension of Study TRCA-301 (NCT03317444). Eligible subjects who complete the 12-week treatment period in Study TRCA-301 have the option to participate in this extension study evaluating the long-term safety and durability of effect of TRC101 in subjects with non-dialysis dependent chronic kidney disease and metabolic acidosis. Eligible subjects will be treated with TRC101 or placebo once daily (QD) on an out-patient basis for the subsequent 40 weeks. Subjects will continue to receive the same blinded treatment (TRC101 or placebo) that they received in Study TRCA-301.",null,"A Blinded, Placebo-Controlled Extension to Study TRCA-301 to Evaluate the Long-term Safety and Durability of Effect of TRC101 in Subjects With Chronic Kidney Disease and Metabolic Acidosis","TRCA-301E","Metabolic Acidosis","Acidosis","Metabolic Diseases","Nutritional Disorders","Experimental|Placebo Comparator","TRC101|Placebo","Administered once daily (QD) for 40 weeks","Drug","TRC101|Placebo","Oral suspension","Veverimer","TRC101|Placebo","\n\n * Completed the 12-week treatment period and attended the Week 12 Visit in the parent study TRCA-301.\n * Blood bicarbonate level of >= 12 mEq/L at the Week 12 Visit in the parent study TRCA-301.\n\nKey ","\n\n * Any level of low blood bicarbonate at the Week 12 Visit that, in the opinion of the Investigator, requires emergency intervention or evaluation for an acute acidotic process.\n * Required dialysis for acute kidney injury or worsening CKD during the parent study TRCA-301.\n * Planned initiation of renal replacement therapy within 6 months following study entry.\n * History or current diagnosis of diabetic gastroparesis, bowel obstruction, swallowing disorders, severe gastrointestinal disorders, inflammatory bowel disease, major gastrointestinal surgery, or active gastric/duodenal ulcers.\n * Serum calcium <= 8.0 mg/dL at the Week 10 in the parent study TRCA-301.",{"$nulls":4},"Actual","2018-01-04","Actual","Actual","2019-02-22","Actual","2019-03-01","2017-12-28","2017-12-28","2019-03-11","Yes","blood bicarbonate, kidney disease","Interventional","Treatment","Parallel Assignment","Triple (Participant, Care Provider, Investigator)","Randomized","18 Years","85 Years","All",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":19},"Incidence of adverse events (AEs), serious adverse events (SAEs), and AEs leading to withdrawal.","Safety.","From Week 12 (enrollment) to Week 54 (last follow-up visit).","Change from baseline in blood bicarbonate.","Efficacy.","Week 52 (end of treatment)",{"$nulls":3},"Sofia, Bulgaria|Tbilisi, Georgia Investigative Site 32Tbilisi, Georgia Investigative Site 33Tbilisi, Georgia Investigative Site 34Tbilisi, Georgia Investigative Site 35Tbilisi, Georgia Investigative Site 36Tbilisi, Georgia Investigative Site 37Tbilisi, Georgia|Budapest, Hungary Investigative Site 46Budapest, Hungary Investigative Site 49HÃ³dmezÅ‘vÃ¡sÃ¡rhely, Hungary Investigative Site 44Kistarcsa, Hungary|VrÅ¡ac, Serbia|Jesenice, Slovenia Investigative Site 71Maribor, Slovenia|Kharkiv, Ukraine Investigative Site 83Kharkiv, Ukraine Investigative Site 87Kharkiv, Ukraine Investigative Site 88Kharkiv, Ukraine Investigative Site 84Kyiv, Ukraine Investigative Site 85Kyiv, Ukraine Investigative Site 86Kyiv, Ukraine|Phoenix, Arizona, United States, 85032|Los Angeles, California, United States, 90022|Hialeah, Florida, United States, 33015 Investigative Site 93Hollywood, Florida, United States, 33024 Investigative Site 92Lauderdale Lakes, Florida, United States, 33313|Atlanta, Georgia, United States, 30342|San Antonio, Texas, United States, 78215","Arizona|California|Florida|Georgia|Texas","Bulgaria|Georgia|Hungary|Serbia|Slovenia|Ukraine|United States","Investigative Site 11|Investigative Site 31|Investigative Site 41|Investigative Site 61|Investigative Site 72|Investigative Site 81|Investigative Site 55|Investigative Site 91|Investigative Site 59|Investigative Site 95|Investigative Site 52",{"$nulls":4},"2019-03-11","2020-05-25T16:35:15.658","2020-05-26T17:10:42.972","NCT03390842"]
["5ecbf3c3307e3d1b1f8d9c33","NCT03390842","2019-08-14","Tricida","TCDA","Completed","Long-term Safety Extension to Study TRCA-301","Trc-101",null,"Yes","['Trc-101']","Unknown",null,"Phase 3",2,196,"Actual","2017-12-20","2019-02-22",{"$nulls":5},"This study is a 40-week, blinded, placebo-controlled extension of Study TRCA-301 (NCT03317444). Eligible subjects who complete the 12-week treatment period in Study TRCA-301 have the option to participate in this extension study evaluating the long-term safety and durability of effect of TRC101 in subjects with non-dialysis dependent chronic kidney disease and metabolic acidosis. Eligible subjects will be treated with TRC101 or placebo once daily (QD) on an out-patient basis for the subsequent 40 weeks. Subjects will continue to receive the same blinded treatment (TRC101 or placebo) that they received in Study TRCA-301.",null,"A Blinded, Placebo-Controlled Extension to Study TRCA-301 to Evaluate the Long-term Safety and Durability of Effect of TRC101 in Subjects With Chronic Kidney Disease and Metabolic Acidosis","TRCA-301E","Metabolic Acidosis","Acidosis","Metabolic Diseases","Nutritional Disorders","Experimental|Placebo Comparator","TRC101|Placebo","Administered once daily (QD) for 40 weeks","Drug","TRC101|Placebo","Oral suspension","Veverimer","TRC101|Placebo","\n\n * Completed the 12-week treatment period and attended the Week 12 Visit in the parent study TRCA-301.\n * Blood bicarbonate level of >= 12 mEq/L at the Week 12 Visit in the parent study TRCA-301.\n\nKey ","\n\n * Any level of low blood bicarbonate at the Week 12 Visit that, in the opinion of the Investigator, requires emergency intervention or evaluation for an acute acidotic process.\n * Required dialysis for acute kidney injury or worsening CKD during the parent study TRCA-301.\n * Planned initiation of renal replacement therapy within 6 months following study entry.\n * History or current diagnosis of diabetic gastroparesis, bowel obstruction, swallowing disorders, severe gastrointestinal disorders, inflammatory bowel disease, major gastrointestinal surgery, or active gastric/duodenal ulcers.\n * Serum calcium <= 8.0 mg/dL at the Week 10 in the parent study TRCA-301.",{"$nulls":4},"Actual","2018-01-04","Actual","Actual","2019-02-22","Actual","2019-08-01","2017-12-28","2017-12-28","2019-08-12","Yes","blood bicarbonate, kidney disease","Interventional","Treatment","Parallel Assignment","Triple (Participant, Care Provider, Investigator)","Randomized","18 Years","85 Years","All",null,"No","No","[Study Results] Wesson DE, Mathur V, Tangri N, Stasiv Y, Parsell D, Li E, Klaerner G, Bushinsky DA. Long-term safety and efficacy of veverimer in patients with metabolic acidosis in chronic kidney disease: a multicentre, randomised, blinded, placebo-controlled, 40-week extension. Lancet. 2019 Aug 3;394(10196):396-406. doi: 10.1016/S0140-6736(19)31388-1. Epub 2019 Jun 24. PubMed 31248662",null,null,"Yes","No",{"$nulls":19},"Incidence of adverse events (AEs), serious adverse events (SAEs), and AEs leading to withdrawal.","Safety.","From Week 12 (enrollment) to Week 54 (last follow-up visit).","Change from baseline in blood bicarbonate.","Efficacy.","Week 52 (end of treatment)",{"$nulls":3},"Sofia, Bulgaria|Tbilisi, Georgia Investigative Site 32Tbilisi, Georgia Investigative Site 33Tbilisi, Georgia Investigative Site 34Tbilisi, Georgia Investigative Site 35Tbilisi, Georgia Investigative Site 36Tbilisi, Georgia Investigative Site 37Tbilisi, Georgia|Budapest, Hungary Investigative Site 46Budapest, Hungary Investigative Site 49HÃ³dmezÅ‘vÃ¡sÃ¡rhely, Hungary Investigative Site 44Kistarcsa, Hungary|VrÅ¡ac, Serbia|Jesenice, Slovenia Investigative Site 71Maribor, Slovenia|Kharkiv, Ukraine Investigative Site 83Kharkiv, Ukraine Investigative Site 87Kharkiv, Ukraine Investigative Site 88Kharkiv, Ukraine Investigative Site 84Kyiv, Ukraine Investigative Site 85Kyiv, Ukraine Investigative Site 86Kyiv, Ukraine|Phoenix, Arizona, United States, 85032|Los Angeles, California, United States, 90022|Hialeah, Florida, United States, 33015 Investigative Site 93Hollywood, Florida, United States, 33024 Investigative Site 92Lauderdale Lakes, Florida, United States, 33313|Atlanta, Georgia, United States, 30342|San Antonio, Texas, United States, 78215","Arizona|California|Florida|Georgia|Texas","Bulgaria|Georgia|Hungary|Serbia|Slovenia|Ukraine|United States","Investigative Site 11|Investigative Site 31|Investigative Site 41|Investigative Site 61|Investigative Site 72|Investigative Site 81|Investigative Site 55|Investigative Site 91|Investigative Site 59|Investigative Site 95|Investigative Site 52",{"$nulls":4},"2019-08-12","2020-05-25T16:35:15.653","2020-05-26T17:10:42.972","NCT03390842"]
["5ecbf3c311702c1b1b9169b7","NCT03390842","2019-10-14","Tricida","TCDA","Completed","Long-term Safety Extension to Study TRCA-301","Trc-101",null,"Yes","['Trc-101']","Unknown",null,"Phase 3",2,196,"Actual","2017-12-20","2019-02-22",{"$nulls":5},"This study is a 40-week, blinded, placebo-controlled extension of Study TRCA-301 (NCT03317444). Eligible subjects who complete the 12-week treatment period in Study TRCA-301 have the option to participate in this extension study evaluating the long-term safety and durability of effect of TRC101 in subjects with non-dialysis dependent chronic kidney disease and metabolic acidosis. Eligible subjects will be treated with TRC101 or placebo once daily (QD) on an out-patient basis for the subsequent 40 weeks. Subjects will continue to receive the same blinded treatment (TRC101 or placebo) that they received in Study TRCA-301.",null,"A Blinded, Placebo-Controlled Extension to Study TRCA-301 to Evaluate the Long-term Safety and Durability of Effect of TRC101 in Subjects With Chronic Kidney Disease and Metabolic Acidosis","TRCA-301E","Metabolic Acidosis","Acidosis","Metabolic Diseases","Nutritional Disorders","Experimental|Placebo Comparator","TRC101|Placebo","Administered once daily (QD) for 40 weeks","Drug","TRC101|Placebo","Oral suspension","Veverimer","TRC101|Placebo","\n\n * Completed the 12-week treatment period and attended the Week 12 Visit in the parent study TRCA-301.\n * Blood bicarbonate level of >= 12 mEq/L at the Week 12 Visit in the parent study TRCA-301.\n\nKey ","\n\n * Any level of low blood bicarbonate at the Week 12 Visit that, in the opinion of the Investigator, requires emergency intervention or evaluation for an acute acidotic process.\n * Required dialysis for acute kidney injury or worsening CKD during the parent study TRCA-301.\n * Planned initiation of renal replacement therapy within 6 months following study entry.\n * History or current diagnosis of diabetic gastroparesis, bowel obstruction, swallowing disorders, severe gastrointestinal disorders, inflammatory bowel disease, major gastrointestinal surgery, or active gastric/duodenal ulcers.\n * Serum calcium <= 8.0 mg/dL at the Week 10 in the parent study TRCA-301.",{"$nulls":4},"Actual","2018-01-04","Actual","Actual","2019-02-22","Actual","2019-10-01","2017-12-28","2017-12-28","2019-10-03","Yes","blood bicarbonate, kidney disease","Interventional","Treatment","Parallel Assignment","Triple (Participant, Care Provider, Investigator)","Randomized","18 Years","85 Years","All",null,"No","No","[Study Results] Wesson DE, Mathur V, Tangri N, Stasiv Y, Parsell D, Li E, Klaerner G, Bushinsky DA. Long-term safety and efficacy of veverimer in patients with metabolic acidosis in chronic kidney disease: a multicentre, randomised, blinded, placebo-controlled, 40-week extension. Lancet. 2019 Aug 3;394(10196):396-406. doi: 10.1016/S0140-6736(19)31388-1. Epub 2019 Jun 24. PubMed 31248662",null,null,"Yes","No",{"$nulls":7},43741,43741,"October 14, 2019 [Actual]",{"$nulls":9},"Incidence of adverse events (AEs), serious adverse events (SAEs), and AEs leading to withdrawal.","Safety.","From Week 12 (enrollment) to Week 54 (last follow-up visit).","Change from baseline in blood bicarbonate.","Efficacy.","Week 52 (end of treatment)",{"$nulls":3},"Sofia, Bulgaria|Tbilisi, Georgia Investigative Site 32Tbilisi, Georgia Investigative Site 33Tbilisi, Georgia Investigative Site 34Tbilisi, Georgia Investigative Site 35Tbilisi, Georgia Investigative Site 36Tbilisi, Georgia Investigative Site 37Tbilisi, Georgia|Budapest, Hungary Investigative Site 46Budapest, Hungary Investigative Site 49HÃ³dmezÅ‘vÃ¡sÃ¡rhely, Hungary Investigative Site 44Kistarcsa, Hungary|VrÅ¡ac, Serbia|Jesenice, Slovenia Investigative Site 71Maribor, Slovenia|Kharkiv, Ukraine Investigative Site 83Kharkiv, Ukraine Investigative Site 87Kharkiv, Ukraine Investigative Site 88Kharkiv, Ukraine Investigative Site 84Kyiv, Ukraine Investigative Site 85Kyiv, Ukraine Investigative Site 86Kyiv, Ukraine|Phoenix, Arizona, United States, 85032|Los Angeles, California, United States, 90022|Hialeah, Florida, United States, 33015 Investigative Site 93Hollywood, Florida, United States, 33024 Investigative Site 92Lauderdale Lakes, Florida, United States, 33313|Atlanta, Georgia, United States, 30342|San Antonio, Texas, United States, 78215","Arizona|California|Florida|Georgia|Texas","Bulgaria|Georgia|Hungary|Serbia|Slovenia|Ukraine|United States","Investigative Site 11|Investigative Site 31|Investigative Site 41|Investigative Site 61|Investigative Site 72|Investigative Site 81|Investigative Site 55|Investigative Site 91|Investigative Site 59|Investigative Site 95|Investigative Site 52",{"$nulls":4},"2019-10-03","2020-05-25T16:35:15.761","2020-05-26T17:10:42.972","NCT03390842"]
["5ecbf3c6307e3d1b1f8d9c39","NCT03391466","2018-01-05","Gilead Sciences","GILD","Recruiting","A Study Evaluating the Efficacy of Axicabtagene Ciloleucel Compared to Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma (ZUMA-7)","Axicabtagene ciloleucel|Autologous stem cell transplant","CAR-T|Autologous Cell Therapy","Yes","['Axicabtagene ciloleucel']","Yes","['CAR-T', 'Autologous Cell Therapy']","Phase 3",2,350,"Anticipated","2017-12-14","2022-01-15","EFS","Event Free Survival",{"$nulls":3},"The purpose of this study is to evaluate whether axicabtagene ciloleucel therapy improves the clinical outcome compared with standard of care second-line therapy in patients with relapsed/refractory DLBCL.","This is a phase 3 randomized, open-label, multicenter study evaluating the efficacy of axicabtagene ciloleucel versus standard of care therapy in subjects with relapsed/refractory DLBCL. Adult subjects with relapsed/refractory DLBCL after first-line rituximab and anthracycline-based chemotherapy will be randomized in a 1:1 ratio to receive axicabtagene ciloleucel or standard of care second-line therapy.\n\nStandard of care will consist of a protocol-defined, platinum-based salvage combination chemotherapy regimen followed by high-dose therapy and autologous stem cell transplant in those who respond to salvage chemotherapy.","A Phase 3, Randomized, Open-Label Study Evaluating Efficacy of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma","KTE-C19-107","Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)","Diffuse Large B-Cell Lymphoma|Lymphoma|Lymphoma, B-Cell","Oncology Hematological","Oncology","Experimental|Active Comparator","Axicabtagene Ciloleucel Treatment|Standard of Care Therapy",null,"Drug","Axicabtagene Ciloleucel|Platinum-containing salvage chemotherapy (eg, R-ICE) followed by high dose therapy (eg, BEAM) and autologous stem cell transplant in responders.","Intervention Description: N/A.","KTE-C19 | axi-cel","Axicabtagene Ciloleucel Treatment|Standard of Care Therapy","\n\n 1. Histologically proven DLBCL, including transformation from follicular lymphoma\n 2. Relapsed or refractory disease after first-line chemoimmunotherapy * Refractory disease is defined as no complete remission to first-line therapy; subjects who are intolerant to first-line therapy are excluded. * Progressive disease (PD) as best response to first-line therapy\n        * Stable disease (SD) as best response after at least 4 cycles of first-line therapy\n        * Partial response (PR) as best response after at least 6 cycles and biopsy-proven residual disease or disease progression â‰¤ 12 months from initiation of therapy\n       \n       \n     * Relapsed disease defined as complete remission to first-line therapy followed by biopsy-proven relapse â‰¤ 12 months of initiating first-line therapy\n    \n    \n 3. Subjects must have received adequate first-line therapy including at a minimum: * Anti-CD20 monoclonal antibody unless investigator determines that tumor is CD20 negative, and\n     * An anthracycline containing chemotherapy regimen\n    \n    \n 4. No known history or suspicion of central nervous system involvement by lymphoma\n 5. ECOG performance status of 0 or 1\n 6. Adequate bone marrow function as evidenced by: * ANC â‰¥ 1000/uL\n     * Platelet â‰¥ 75,000/uL\n     * Absolute lymphocyte count â‰¥ 100/uL\n    \n    \n 7. Adequate renal, hepatic, cardiac, and pulmonary function as evidenced by: * Creatinine clearance (Cockcroft Gault) â‰¥ 60 mL/min\n     * Serum ALT/AST â‰¤ 2.5 ULN\n     * Total bilirubin â‰¤ 1.5 mg/dl\n     * Cardiac ejection fraction â‰¥ 50%, no evidence of pericardial effusion as determined by an ECHO, and no clinically significant ECG findings\n     * No clinically significant pleural effusion\n     * Baseline oxygen saturation > 92% on room air\n    \n    \n\nKey ","\n\n 1.  History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (eg cervix, bladder, breast) unless disease free for at least 3 years\n 2.  Received more than one line of therapy for DLBCL\n 3.  History of autologous or allogeneic stem cell transplant\n 4.  Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring intravenous antimicrobials for management.\n 5.  Known history of infection with human immunodeficiency virus (HIV) or hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive). If there is a positive history of treated hepatitis B or hepatitis C, the viral load must be undetectable per quantitative polymerase chain reaction (PCR) and/or nucleic acid testing.\n 6.  Subjects with detectable cerebrospinal fluid malignant cells or known brain metastases, or with a history of cerebrospinal fluid malignant cells or brain metastases.\n 7.  History or presence of non-malignant CNS disorder such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement\n 8.  Presence of any indwelling line or drain. Dedicated central venous access catheter such as a Port-a-Cath or Hickman catheter are permitted.\n 9.  History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, New York Heart Association Class II or greater congestive heart failure, or other clinically significant cardiac diseases within 12 months of enrollment\n 10. History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months of enrollment\n 11. History of autoimmune disease, requiring systemic immunosuppression and/or systemic disease modifying agents within the last 2 years\n 12. History of anti-CD19 or CAR-T therapy or history of prior randomization in ZUMA-7",{"$nulls":4},"Actual","2018-01-05","Actual","Anticipated","2035-01-15","Anticipated","2017-12-01","2017-12-21","2017-12-29","2017-12-29","Yes",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No","Yes",{"$nulls":3},"Yes","No",{"$nulls":19},"Event Free Survival","3 years",null,"Objective Response Rate|Overall Survival Rate","3 years|4 years",null,"medinfo@kitepharma.com","Kite MD",{"$f":"1-844-454-5483","v":-6780},"Tampa, Florida, United States, 12902","Florida","United States","Moffitt Cancer Center",{"$nulls":4},"2017-12-29","2020-05-25T16:35:18.374","2020-05-26T17:10:42.972","NCT03391466"]
["5ecbf3c6feab101b155307d8","NCT03391466","2018-01-10","Gilead Sciences","GILD","Recruiting","A Study Evaluating the Efficacy of Axicabtagene Ciloleucel Compared to Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma (ZUMA-7)","Axicabtagene ciloleucel|Autologous stem cell transplant","CAR-T|Autologous Cell Therapy","Yes","['Axicabtagene ciloleucel']","Yes","['CAR-T', 'Autologous Cell Therapy']","Phase 3",2,350,"Anticipated","2017-12-14","2022-01-15","EFS","Event Free Survival",{"$nulls":3},"The purpose of this study is to evaluate whether axicabtagene ciloleucel therapy improves the clinical outcome compared with standard of care second-line therapy in patients with relapsed/refractory DLBCL.","This is a phase 3 randomized, open-label, multicenter study evaluating the efficacy of axicabtagene ciloleucel versus standard of care therapy in subjects with relapsed/refractory DLBCL. Adult subjects with relapsed/refractory DLBCL after first-line rituximab and anthracycline-based chemotherapy will be randomized in a 1:1 ratio to receive axicabtagene ciloleucel or standard of care second-line therapy.\n\nStandard of care will consist of a protocol-defined, platinum-based salvage combination chemotherapy regimen followed by high-dose therapy and autologous stem cell transplant in those who respond to salvage chemotherapy.","A Phase 3, Randomized, Open-Label Study Evaluating Efficacy of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma","KTE-C19-107","Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)","Diffuse Large B-Cell Lymphoma|Lymphoma|Lymphoma, B-Cell","Oncology Hematological","Oncology","Experimental|Active Comparator","Axicabtagene Ciloleucel Treatment|Standard of Care Therapy",null,"Drug","Axicabtagene Ciloleucel|Platinum-containing salvage chemotherapy (eg, R-ICE) followed by high dose therapy (eg, BEAM) and autologous stem cell transplant in responders.","Intervention Description: N/A.","KTE-C19 | axi-cel","Axicabtagene Ciloleucel Treatment|Standard of Care Therapy","\n\n 1. Histologically proven DLBCL, including transformation from follicular lymphoma\n 2. Relapsed or refractory disease after first-line chemoimmunotherapy * Refractory disease is defined as no complete remission to first-line therapy; subjects who are intolerant to first-line therapy are excluded. * Progressive disease (PD) as best response to first-line therapy\n        * Stable disease (SD) as best response after at least 4 cycles of first-line therapy\n        * Partial response (PR) as best response after at least 6 cycles and biopsy-proven residual disease or disease progression â‰¤ 12 months from initiation of therapy\n       \n       \n     * Relapsed disease defined as complete remission to first-line therapy followed by biopsy-proven relapse â‰¤ 12 months of initiating first-line therapy\n    \n    \n 3. Subjects must have received adequate first-line therapy including at a minimum: * Anti-CD20 monoclonal antibody unless investigator determines that tumor is CD20 negative, and\n     * An anthracycline containing chemotherapy regimen\n    \n    \n 4. No known history or suspicion of central nervous system involvement by lymphoma\n 5. ECOG performance status of 0 or 1\n 6. Adequate bone marrow function as evidenced by: * ANC â‰¥ 1000/uL\n     * Platelet â‰¥ 75,000/uL\n     * Absolute lymphocyte count â‰¥ 100/uL\n    \n    \n 7. Adequate renal, hepatic, cardiac, and pulmonary function as evidenced by: * Creatinine clearance (Cockcroft Gault) â‰¥ 60 mL/min\n     * Serum ALT/AST â‰¤ 2.5 ULN\n     * Total bilirubin â‰¤ 1.5 mg/dl\n     * Cardiac ejection fraction â‰¥ 50%, no evidence of pericardial effusion as determined by an ECHO, and no clinically significant ECG findings\n     * No clinically significant pleural effusion\n     * Baseline oxygen saturation > 92% on room air\n    \n    \n\nKey ","\n\n 1.  History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (eg cervix, bladder, breast) unless disease free for at least 3 years\n 2.  Received more than one line of therapy for DLBCL\n 3.  History of autologous or allogeneic stem cell transplant\n 4.  Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring intravenous antimicrobials for management.\n 5.  Known history of infection with human immunodeficiency virus (HIV) or hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive). If there is a positive history of treated hepatitis B or hepatitis C, the viral load must be undetectable per quantitative polymerase chain reaction (PCR) and/or nucleic acid testing.\n 6.  Subjects with detectable cerebrospinal fluid malignant cells or known brain metastases, or with a history of cerebrospinal fluid malignant cells or brain metastases.\n 7.  History or presence of non-malignant CNS disorder such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement\n 8.  Presence of any indwelling line or drain. Dedicated central venous access catheter such as a Port-a-Cath or Hickman catheter are permitted.\n 9.  History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, New York Heart Association Class II or greater congestive heart failure, or other clinically significant cardiac diseases within 12 months of enrollment\n 10. History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months of enrollment\n 11. History of autoimmune disease, requiring systemic immunosuppression and/or systemic disease modifying agents within the last 2 years\n 12. History of anti-CD19 or CAR-T therapy or history of prior randomization in ZUMA-7",{"$nulls":4},"Actual","2018-01-05","Actual","Anticipated","2035-01-15","Anticipated","2018-01-01","2017-12-21","2017-12-29","2018-01-08","Yes",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No","Yes",{"$nulls":3},"Yes","No",{"$nulls":19},"Event Free Survival","3 years",null,"Objective Response Rate|Overall Survival","3 years|4 years",null,"medinfo@kitepharma.com","Kite MD",-6780,"Tampa, Florida, United States, 12902|Nashville, Tennessee, United States, 37232","Florida|Tennessee","United States","Moffitt Cancer Center|Vanderbilt University",{"$nulls":4},"2018-01-08","2020-05-25T16:35:18.044","2020-05-26T17:10:42.972","NCT03391466"]
["5ecbf3c611702c1b1b9169bc","NCT03391466","2018-03-06","Gilead Sciences","GILD","Recruiting","A Study Evaluating the Efficacy of Axicabtagene Ciloleucel Compared to Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma (ZUMA-7)","Axicabtagene ciloleucel|Autologous stem cell transplant","CAR-T|Autologous Cell Therapy","Yes","['Axicabtagene ciloleucel']","Yes","['CAR-T', 'Autologous Cell Therapy']","Phase 3",2,350,"Anticipated","2017-12-14","2022-01-15","EFS","Event Free Survival",{"$nulls":3},"The purpose of this study is to evaluate whether axicabtagene ciloleucel therapy improves the clinical outcome compared with standard of care second-line therapy in patients with relapsed/refractory DLBCL.","This is a phase 3 randomized, open-label, multicenter study evaluating the efficacy of axicabtagene ciloleucel versus standard of care therapy in subjects with relapsed/refractory DLBCL. Adult subjects with relapsed/refractory DLBCL after first-line rituximab and anthracycline-based chemotherapy will be randomized in a 1:1 ratio to receive axicabtagene ciloleucel or standard of care second-line therapy.\n\nStandard of care will consist of a protocol-defined, platinum-based salvage combination chemotherapy regimen followed by high-dose therapy and autologous stem cell transplant in those who respond to salvage chemotherapy.","A Phase 3, Randomized, Open-Label Study Evaluating Efficacy of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma","KTE-C19-107","Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)","Diffuse Large B-Cell Lymphoma|Lymphoma|Lymphoma, B-Cell","Oncology Hematological","Oncology","Experimental|Active Comparator","Axicabtagene Ciloleucel Treatment|Standard of Care Therapy",null,"Drug","Axicabtagene Ciloleucel|Platinum-containing salvage chemotherapy (eg, R-ICE) followed by high dose therapy (eg, BEAM) and autologous stem cell transplant in responders.","Intervention Description: N/A.","KTE-C19 | axi-cel","Axicabtagene Ciloleucel Treatment|Standard of Care Therapy","\n\n 1. Histologically proven DLBCL, including transformation from follicular lymphoma\n 2. Relapsed or refractory disease after first-line chemoimmunotherapy * Refractory disease is defined as no complete remission to first-line therapy; subjects who are intolerant to first-line therapy are excluded. * Progressive disease (PD) as best response to first-line therapy\n        * Stable disease (SD) as best response after at least 4 cycles of first-line therapy\n        * Partial response (PR) as best response after at least 6 cycles and biopsy-proven residual disease or disease progression â‰¤ 12 months from initiation of therapy\n       \n       \n     * Relapsed disease defined as complete remission to first-line therapy followed by biopsy-proven relapse â‰¤ 12 months of initiating first-line therapy\n    \n    \n 3. Subjects must have received adequate first-line therapy including at a minimum: * Anti-CD20 monoclonal antibody unless investigator determines that tumor is CD20 negative, and\n     * An anthracycline containing chemotherapy regimen\n    \n    \n 4. No known history or suspicion of central nervous system involvement by lymphoma\n 5. ECOG performance status of 0 or 1\n 6. Adequate bone marrow function as evidenced by: * ANC â‰¥ 1000/uL\n     * Platelet â‰¥ 75,000/uL\n     * Absolute lymphocyte count â‰¥ 100/uL\n    \n    \n 7. Adequate renal, hepatic, cardiac, and pulmonary function as evidenced by: * Creatinine clearance (Cockcroft Gault) â‰¥ 60 mL/min\n     * Serum ALT/AST â‰¤ 2.5 ULN\n     * Total bilirubin â‰¤ 1.5 mg/dl\n     * Cardiac ejection fraction â‰¥ 50%, no evidence of pericardial effusion as determined by an ECHO, and no clinically significant ECG findings\n     * No clinically significant pleural effusion\n     * Baseline oxygen saturation > 92% on room air\n    \n    \n\nKey ","\n\n 1.  History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (eg cervix, bladder, breast) unless disease free for at least 3 years\n 2.  Received more than one line of therapy for DLBCL\n 3.  History of autologous or allogeneic stem cell transplant\n 4.  Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring intravenous antimicrobials for management.\n 5.  Known history of infection with human immunodeficiency virus (HIV) or hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive). If there is a positive history of treated hepatitis B or hepatitis C, the viral load must be undetectable per quantitative polymerase chain reaction (PCR) and/or nucleic acid testing.\n 6.  Subjects with detectable cerebrospinal fluid malignant cells or known brain metastases, or with a history of cerebrospinal fluid malignant cells or brain metastases.\n 7.  History or presence of non-malignant CNS disorder such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement\n 8.  Presence of any indwelling line or drain. Dedicated central venous access catheter such as a Port-a-Cath or Hickman catheter are permitted.\n 9.  History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, New York Heart Association Class II or greater congestive heart failure, or other clinically significant cardiac diseases within 12 months of enrollment\n 10. History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months of enrollment\n 11. History of autoimmune disease, requiring systemic immunosuppression and/or systemic disease modifying agents within the last 2 years\n 12. History of anti-CD19 or CAR-T therapy or history of prior randomization in ZUMA-7",{"$nulls":4},"Actual","2018-01-05","Actual","Anticipated","2035-01-15","Anticipated","2018-01-01","2017-12-21","2017-12-29","2018-03-02","Yes",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No","Yes",{"$nulls":3},"Yes","No",{"$nulls":19},"Event Free Survival","3 years",null,"Objective Response Rate|Overall Survival","3 years|4 years",null,"medinfo@kitepharma.com","Kite MD",-6780,"Tampa, Florida, United States, 12902|Boston, Massachusetts, United States, 02215|Nashville, Tennessee, United States, 37232","Florida|Massachusetts|Tennessee","United States","Moffitt Cancer Center|Dana-Farber Cancer Institute|Vanderbilt University",{"$nulls":4},"2018-03-02","2020-05-25T16:35:18.129","2020-05-26T17:10:42.972","NCT03391466"]
["5ecbf3c6e2561b1b11905ca4","NCT03391466","2018-03-14","Gilead Sciences","GILD","Recruiting","A Study Evaluating the Efficacy of Axicabtagene Ciloleucel Compared to Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma (ZUMA-7)","Axicabtagene ciloleucel|Autologous stem cell transplant","CAR-T|Autologous Cell Therapy","Yes","['Axicabtagene ciloleucel']","Yes","['CAR-T', 'Autologous Cell Therapy']","Phase 3",2,350,"Anticipated","2017-12-14","2022-01-15","EFS","Event Free Survival",{"$nulls":3},"The purpose of this study is to evaluate whether axicabtagene ciloleucel therapy improves the clinical outcome compared with standard of care second-line therapy in patients with relapsed/refractory DLBCL.","This is a phase 3 randomized, open-label, multicenter study evaluating the efficacy of axicabtagene ciloleucel versus standard of care therapy in subjects with relapsed/refractory DLBCL. Adult subjects with relapsed/refractory DLBCL after first-line rituximab and anthracycline-based chemotherapy will be randomized in a 1:1 ratio to receive axicabtagene ciloleucel or standard of care second-line therapy.\n\nStandard of care will consist of a protocol-defined, platinum-based salvage combination chemotherapy regimen followed by high-dose therapy and autologous stem cell transplant in those who respond to salvage chemotherapy.","A Phase 3, Randomized, Open-Label Study Evaluating Efficacy of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma","KTE-C19-107","Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)","Diffuse Large B-Cell Lymphoma|Lymphoma|Lymphoma, B-Cell","Oncology Hematological","Oncology","Experimental|Active Comparator","Axicabtagene Ciloleucel Treatment|Standard of Care Therapy",null,"Drug","Axicabtagene Ciloleucel|Platinum-containing salvage chemotherapy (eg, R-ICE) followed by high dose therapy (eg, BEAM) and autologous stem cell transplant in responders.","Intervention Description: N/A.","KTE-C19 | axi-cel","Axicabtagene Ciloleucel Treatment|Standard of Care Therapy","\n\n 1. Histologically proven DLBCL, including transformation from follicular lymphoma\n 2. Relapsed or refractory disease after first-line chemoimmunotherapy * Refractory disease is defined as no complete remission to first-line therapy; subjects who are intolerant to first-line therapy are excluded. * Progressive disease (PD) as best response to first-line therapy\n        * Stable disease (SD) as best response after at least 4 cycles of first-line therapy\n        * Partial response (PR) as best response after at least 6 cycles and biopsy-proven residual disease or disease progression â‰¤ 12 months from initiation of therapy\n       \n       \n     * Relapsed disease defined as complete remission to first-line therapy followed by biopsy-proven relapse â‰¤ 12 months of initiating first-line therapy\n    \n    \n 3. Subjects must have received adequate first-line therapy including at a minimum: * Anti-CD20 monoclonal antibody unless investigator determines that tumor is CD20 negative, and\n     * An anthracycline containing chemotherapy regimen\n    \n    \n 4. No known history or suspicion of central nervous system involvement by lymphoma\n 5. ECOG performance status of 0 or 1\n 6. Adequate bone marrow function as evidenced by: * ANC â‰¥ 1000/uL\n     * Platelet â‰¥ 75,000/uL\n     * Absolute lymphocyte count â‰¥ 100/uL\n    \n    \n 7. Adequate renal, hepatic, cardiac, and pulmonary function as evidenced by: * Creatinine clearance (Cockcroft Gault) â‰¥ 60 mL/min\n     * Serum ALT/AST â‰¤ 2.5 ULN\n     * Total bilirubin â‰¤ 1.5 mg/dl\n     * Cardiac ejection fraction â‰¥ 50%, no evidence of pericardial effusion as determined by an ECHO, and no clinically significant ECG findings\n     * No clinically significant pleural effusion\n     * Baseline oxygen saturation > 92% on room air\n    \n    \n\nKey ","\n\n 1.  History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (eg cervix, bladder, breast) unless disease free for at least 3 years\n 2.  Received more than one line of therapy for DLBCL\n 3.  History of autologous or allogeneic stem cell transplant\n 4.  Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring intravenous antimicrobials for management.\n 5.  Known history of infection with human immunodeficiency virus (HIV) or hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive). If there is a positive history of treated hepatitis B or hepatitis C, the viral load must be undetectable per quantitative polymerase chain reaction (PCR) and/or nucleic acid testing.\n 6.  Subjects with detectable cerebrospinal fluid malignant cells or known brain metastases, or with a history of cerebrospinal fluid malignant cells or brain metastases.\n 7.  History or presence of non-malignant CNS disorder such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement\n 8.  Presence of any indwelling line or drain. Dedicated central venous access catheter such as a Port-a-Cath or Hickman catheter are permitted.\n 9.  History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, New York Heart Association Class II or greater congestive heart failure, or other clinically significant cardiac diseases within 12 months of enrollment\n 10. History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months of enrollment\n 11. History of autoimmune disease, requiring systemic immunosuppression and/or systemic disease modifying agents within the last 2 years\n 12. History of anti-CD19 or CAR-T therapy or history of prior randomization in ZUMA-7",{"$nulls":4},"Actual","2018-01-05","Actual","Anticipated","2035-01-15","Anticipated","2018-03-01","2017-12-21","2017-12-29","2018-03-12","Yes",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No","Yes",{"$nulls":3},"Yes","No",{"$nulls":19},"Event Free Survival","3 years",null,"Objective Response Rate|Overall Survival","3 years|4 years",null,"medinfo@kitepharma.com","Kite MD",-6780,"Tampa, Florida, United States, 12902|Boston, Massachusetts, United States, 02215|Nashville, Tennessee, United States, 37232|Houston, Texas, United States, 77030","Florida|Massachusetts|Tennessee|Texas","United States","Moffitt Cancer Center|Dana-Farber Cancer Institute|Vanderbilt University|Md Anderson Cancer Center",{"$nulls":4},"2018-03-12","2020-05-25T16:35:18.228","2020-05-26T17:10:42.972","NCT03391466"]
["5ecbf3c6fe30261b1a0481a9","NCT03391466","2018-03-26","Gilead Sciences","GILD","Recruiting","A Study Evaluating the Efficacy of Axicabtagene Ciloleucel Compared to Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma (ZUMA-7)","Axicabtagene ciloleucel|Autologous stem cell transplant","CAR-T|Autologous Cell Therapy","Yes","['Axicabtagene ciloleucel']","Yes","['CAR-T', 'Autologous Cell Therapy']","Phase 3",2,350,"Anticipated","2017-12-14","2022-01-15","EFS","Event Free Survival",{"$nulls":3},"The purpose of this study is to evaluate whether axicabtagene ciloleucel therapy improves the clinical outcome compared with standard of care second-line therapy in patients with relapsed/refractory DLBCL.","This is a phase 3 randomized, open-label, multicenter study evaluating the efficacy of axicabtagene ciloleucel versus standard of care therapy in subjects with relapsed/refractory DLBCL. Adult subjects with relapsed/refractory DLBCL after first-line rituximab and anthracycline-based chemotherapy will be randomized in a 1:1 ratio to receive axicabtagene ciloleucel or standard of care second-line therapy.\n\nStandard of care will consist of a protocol-defined, platinum-based salvage combination chemotherapy regimen followed by high-dose therapy and autologous stem cell transplant in those who respond to salvage chemotherapy.","A Phase 3, Randomized, Open-Label Study Evaluating Efficacy of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma","KTE-C19-107","Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)","Diffuse Large B-Cell Lymphoma|Lymphoma|Lymphoma, B-Cell","Oncology Hematological","Oncology","Experimental|Active Comparator","Axicabtagene Ciloleucel Treatment|Standard of Care Therapy",null,"Drug","Axicabtagene Ciloleucel|Platinum-containing salvage chemotherapy (eg, R-ICE) followed by high dose therapy (eg, BEAM) and autologous stem cell transplant in responders.","Intervention Description: N/A.","KTE-C19 | axi-cel","Axicabtagene Ciloleucel Treatment|Standard of Care Therapy","\n\n 1. Histologically proven DLBCL, including transformation from follicular lymphoma\n 2. Relapsed or refractory disease after first-line chemoimmunotherapy * Refractory disease is defined as no complete remission to first-line therapy; subjects who are intolerant to first-line therapy are excluded. * Progressive disease (PD) as best response to first-line therapy\n        * Stable disease (SD) as best response after at least 4 cycles of first-line therapy\n        * Partial response (PR) as best response after at least 6 cycles and biopsy-proven residual disease or disease progression â‰¤ 12 months from initiation of therapy\n       \n       \n     * Relapsed disease defined as complete remission to first-line therapy followed by biopsy-proven relapse â‰¤ 12 months of initiating first-line therapy\n    \n    \n 3. Subjects must have received adequate first-line therapy including at a minimum: * Anti-CD20 monoclonal antibody unless investigator determines that tumor is CD20 negative, and\n     * An anthracycline containing chemotherapy regimen\n    \n    \n 4. No known history or suspicion of central nervous system involvement by lymphoma\n 5. ECOG performance status of 0 or 1\n 6. Adequate bone marrow function as evidenced by: * ANC â‰¥ 1000/uL\n     * Platelet â‰¥ 75,000/uL\n     * Absolute lymphocyte count â‰¥ 100/uL\n    \n    \n 7. Adequate renal, hepatic, cardiac, and pulmonary function as evidenced by: * Creatinine clearance (Cockcroft Gault) â‰¥ 60 mL/min\n     * Serum ALT/AST â‰¤ 2.5 ULN\n     * Total bilirubin â‰¤ 1.5 mg/dl\n     * Cardiac ejection fraction â‰¥ 50%, no evidence of pericardial effusion as determined by an ECHO, and no clinically significant ECG findings\n     * No clinically significant pleural effusion\n     * Baseline oxygen saturation > 92% on room air\n    \n    \n\nKey ","\n\n 1.  History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (eg cervix, bladder, breast) unless disease free for at least 3 years\n 2.  Received more than one line of therapy for DLBCL\n 3.  History of autologous or allogeneic stem cell transplant\n 4.  Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring intravenous antimicrobials for management.\n 5.  Known history of infection with human immunodeficiency virus (HIV) or hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive). If there is a positive history of treated hepatitis B or hepatitis C, the viral load must be undetectable per quantitative polymerase chain reaction (PCR) and/or nucleic acid testing.\n 6.  Subjects with detectable cerebrospinal fluid malignant cells or known brain metastases, or with a history of cerebrospinal fluid malignant cells or brain metastases.\n 7.  History or presence of non-malignant CNS disorder such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement\n 8.  Presence of any indwelling line or drain. Dedicated central venous access catheter such as a Port-a-Cath or Hickman catheter are permitted.\n 9.  History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, New York Heart Association Class II or greater congestive heart failure, or other clinically significant cardiac diseases within 12 months of enrollment\n 10. History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months of enrollment\n 11. History of autoimmune disease, requiring systemic immunosuppression and/or systemic disease modifying agents within the last 2 years\n 12. History of anti-CD19 or CAR-T therapy or history of prior randomization in ZUMA-7",{"$nulls":4},"Actual","2018-01-05","Actual","Anticipated","2035-01-15","Anticipated","2018-03-01","2017-12-21","2017-12-29","2018-03-22","Yes",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No","Yes",{"$nulls":3},"Yes","No",{"$nulls":19},"Event Free Survival","3 years",null,"Objective Response Rate|Overall Survival","3 years|4 years",null,"medinfo@kitepharma.com","Kite MD",-6780,"Tampa, Florida, United States, 12902|Chicago, Illinois, United States, 60637|Boston, Massachusetts, United States, 02215|Nashville, Tennessee, United States, 37232|Houston, Texas, United States, 77030","Florida|Illinois|Massachusetts|Tennessee|Texas","United States","Moffitt Cancer Center|University Of Chicago|Dana-Farber Cancer Institute|Vanderbilt University|Md Anderson Cancer Center",{"$nulls":4},"2018-03-22","2020-05-25T16:35:18.249","2020-05-26T17:10:42.972","NCT03391466"]
["5ecbf3c611702c1b1b9169bd","NCT03391466","2018-04-03","Gilead Sciences","GILD","Recruiting","A Study Evaluating the Efficacy of Axicabtagene Ciloleucel Compared to Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma (ZUMA-7)","Axicabtagene ciloleucel|Autologous stem cell transplant","CAR-T|Autologous Cell Therapy","Yes","['Axicabtagene ciloleucel']","Yes","['CAR-T', 'Autologous Cell Therapy']","Phase 3",2,350,"Anticipated","2017-12-14","2022-01-15","EFS","Event Free Survival",{"$nulls":3},"The purpose of this study is to evaluate whether axicabtagene ciloleucel therapy improves the clinical outcome compared with standard of care second-line therapy in patients with relapsed/refractory DLBCL.","This is a phase 3 randomized, open-label, multicenter study evaluating the efficacy of axicabtagene ciloleucel versus standard of care therapy in subjects with relapsed/refractory DLBCL. Adult subjects with relapsed/refractory DLBCL after first-line rituximab and anthracycline-based chemotherapy will be randomized in a 1:1 ratio to receive axicabtagene ciloleucel or standard of care second-line therapy.\n\nStandard of care will consist of a protocol-defined, platinum-based salvage combination chemotherapy regimen followed by high-dose therapy and autologous stem cell transplant in those who respond to salvage chemotherapy.","A Phase 3, Randomized, Open-Label Study Evaluating Efficacy of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma","KTE-C19-107","Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)","Diffuse Large B-Cell Lymphoma|Lymphoma|Lymphoma, B-Cell","Oncology Hematological","Oncology","Experimental|Active Comparator","Axicabtagene Ciloleucel Treatment|Standard of Care Therapy",null,"Drug","Axicabtagene Ciloleucel|Platinum-containing salvage chemotherapy (eg, R-ICE) followed by high dose therapy (eg, BEAM) and autologous stem cell transplant in responders.","Intervention Description: N/A.","KTE-C19 | axi-cel","Axicabtagene Ciloleucel Treatment|Standard of Care Therapy","\n\n 1. Histologically proven DLBCL, including transformation from follicular lymphoma\n 2. Relapsed or refractory disease after first-line chemoimmunotherapy * Refractory disease is defined as no complete remission to first-line therapy; subjects who are intolerant to first-line therapy are excluded. * Progressive disease (PD) as best response to first-line therapy\n        * Stable disease (SD) as best response after at least 4 cycles of first-line therapy\n        * Partial response (PR) as best response after at least 6 cycles and biopsy-proven residual disease or disease progression â‰¤ 12 months from initiation of therapy\n       \n       \n     * Relapsed disease defined as complete remission to first-line therapy followed by biopsy-proven relapse â‰¤ 12 months of initiating first-line therapy\n    \n    \n 3. Subjects must have received adequate first-line therapy including at a minimum: * Anti-CD20 monoclonal antibody unless investigator determines that tumor is CD20 negative, and\n     * An anthracycline containing chemotherapy regimen\n    \n    \n 4. No known history or suspicion of central nervous system involvement by lymphoma\n 5. ECOG performance status of 0 or 1\n 6. Adequate bone marrow function as evidenced by: * ANC â‰¥ 1000/uL\n     * Platelet â‰¥ 75,000/uL\n     * Absolute lymphocyte count â‰¥ 100/uL\n    \n    \n 7. Adequate renal, hepatic, cardiac, and pulmonary function as evidenced by: * Creatinine clearance (Cockcroft Gault) â‰¥ 60 mL/min\n     * Serum ALT/AST â‰¤ 2.5 ULN\n     * Total bilirubin â‰¤ 1.5 mg/dl\n     * Cardiac ejection fraction â‰¥ 50%, no evidence of pericardial effusion as determined by an ECHO, and no clinically significant ECG findings\n     * No clinically significant pleural effusion\n     * Baseline oxygen saturation > 92% on room air\n    \n    \n\nKey ","\n\n 1.  History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (eg cervix, bladder, breast) unless disease free for at least 3 years\n 2.  Received more than one line of therapy for DLBCL\n 3.  History of autologous or allogeneic stem cell transplant\n 4.  Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring intravenous antimicrobials for management.\n 5.  Known history of infection with human immunodeficiency virus (HIV) or hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive). If there is a positive history of treated hepatitis B or hepatitis C, the viral load must be undetectable per quantitative polymerase chain reaction (PCR) and/or nucleic acid testing.\n 6.  Subjects with detectable cerebrospinal fluid malignant cells or known brain metastases, or with a history of cerebrospinal fluid malignant cells or brain metastases.\n 7.  History or presence of non-malignant CNS disorder such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement\n 8.  Presence of any indwelling line or drain. Dedicated central venous access catheter such as a Port-a-Cath or Hickman catheter are permitted.\n 9.  History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, New York Heart Association Class II or greater congestive heart failure, or other clinically significant cardiac diseases within 12 months of enrollment\n 10. History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months of enrollment\n 11. History of autoimmune disease, requiring systemic immunosuppression and/or systemic disease modifying agents within the last 2 years\n 12. History of anti-CD19 or CAR-T therapy or history of prior randomization in ZUMA-7",{"$nulls":4},"Actual","2018-01-05","Actual","Anticipated","2035-01-15","Anticipated","2018-04-01","2017-12-21","2017-12-29","2018-04-02","Yes",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No","Yes",{"$nulls":3},"Yes","No",{"$nulls":19},"Event Free Survival","3 years",null,"Objective Response Rate|Overall Survival","3 years|4 years",null,"medinfo@kitepharma.com","Kite MD",-6780,"Tampa, Florida, United States, 12902|Chicago, Illinois, United States, 60637|Boston, Massachusetts, United States, 02215|Rochester, Minnesota, United States, 55905|Saint Louis, Missouri, United States, 63130|Nashville, Tennessee, United States, 37203|Houston, Texas, United States, 77030","Florida|Illinois|Massachusetts|Minnesota|Missouri|Tennessee|Texas","United States","Moffitt Cancer Center|University Of Chicago|Dana-Farber Cancer Institute|Mayo Clinic|Washington University|Sarah Cannon Research Institute|Md Anderson Cancer Center",{"$nulls":4},"2018-04-02","2020-05-25T16:35:18.776","2020-05-26T17:10:42.972","NCT03391466"]
["5ecbf3c6feab101b155307da","NCT03391466","2018-04-05","Gilead Sciences","GILD","Recruiting","A Study Evaluating the Efficacy of Axicabtagene Ciloleucel Compared to Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma (ZUMA-7)","Axicabtagene ciloleucel|Autologous stem cell transplant","CAR-T|Autologous Cell Therapy","Yes","['Axicabtagene ciloleucel']","Yes","['CAR-T', 'Autologous Cell Therapy']","Phase 3",2,350,"Anticipated","2017-12-14","2022-01-15","EFS","Event Free Survival",{"$nulls":3},"The purpose of this study is to evaluate whether axicabtagene ciloleucel therapy improves the clinical outcome compared with standard of care second-line therapy in patients with relapsed/refractory DLBCL.","This is a phase 3 randomized, open-label, multicenter study evaluating the efficacy of axicabtagene ciloleucel versus standard of care therapy in subjects with relapsed/refractory DLBCL. Adult subjects with relapsed/refractory DLBCL after first-line rituximab and anthracycline-based chemotherapy will be randomized in a 1:1 ratio to receive axicabtagene ciloleucel or standard of care second-line therapy.\n\nStandard of care will consist of a protocol-defined, platinum-based salvage combination chemotherapy regimen followed by high-dose therapy and autologous stem cell transplant in those who respond to salvage chemotherapy.","A Phase 3, Randomized, Open-Label Study Evaluating Efficacy of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma","KTE-C19-107","Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)","Diffuse Large B-Cell Lymphoma|Lymphoma|Lymphoma, B-Cell","Oncology Hematological","Oncology","Experimental|Active Comparator","Axicabtagene Ciloleucel Treatment|Standard of Care Therapy",null,"Drug","Axicabtagene Ciloleucel|Platinum-containing salvage chemotherapy (eg, R-ICE) followed by high dose therapy (eg, BEAM) and autologous stem cell transplant in responders.","Intervention Description: N/A.","KTE-C19 | axi-cel","Axicabtagene Ciloleucel Treatment|Standard of Care Therapy","\n\n 1. Histologically proven DLBCL, including transformation from follicular lymphoma\n 2. Relapsed or refractory disease after first-line chemoimmunotherapy * Refractory disease is defined as no complete remission to first-line therapy; subjects who are intolerant to first-line therapy are excluded. * Progressive disease (PD) as best response to first-line therapy\n        * Stable disease (SD) as best response after at least 4 cycles of first-line therapy\n        * Partial response (PR) as best response after at least 6 cycles and biopsy-proven residual disease or disease progression â‰¤ 12 months from initiation of therapy\n       \n       \n     * Relapsed disease defined as complete remission to first-line therapy followed by biopsy-proven relapse â‰¤ 12 months of initiating first-line therapy\n    \n    \n 3. Subjects must have received adequate first-line therapy including at a minimum: * Anti-CD20 monoclonal antibody unless investigator determines that tumor is CD20 negative, and\n     * An anthracycline containing chemotherapy regimen\n    \n    \n 4. No known history or suspicion of central nervous system involvement by lymphoma\n 5. ECOG performance status of 0 or 1\n 6. Adequate bone marrow function as evidenced by: * ANC â‰¥ 1000/uL\n     * Platelet â‰¥ 75,000/uL\n     * Absolute lymphocyte count â‰¥ 100/uL\n    \n    \n 7. Adequate renal, hepatic, cardiac, and pulmonary function as evidenced by: * Creatinine clearance (Cockcroft Gault) â‰¥ 60 mL/min\n     * Serum ALT/AST â‰¤ 2.5 ULN\n     * Total bilirubin â‰¤ 1.5 mg/dl\n     * Cardiac ejection fraction â‰¥ 50%, no evidence of pericardial effusion as determined by an ECHO, and no clinically significant ECG findings\n     * No clinically significant pleural effusion\n     * Baseline oxygen saturation > 92% on room air\n    \n    \n\nKey ","\n\n 1.  History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (eg cervix, bladder, breast) unless disease free for at least 3 years\n 2.  Received more than one line of therapy for DLBCL\n 3.  History of autologous or allogeneic stem cell transplant\n 4.  Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring intravenous antimicrobials for management.\n 5.  Known history of infection with human immunodeficiency virus (HIV) or hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive). If there is a positive history of treated hepatitis B or hepatitis C, the viral load must be undetectable per quantitative polymerase chain reaction (PCR) and/or nucleic acid testing.\n 6.  Subjects with detectable cerebrospinal fluid malignant cells or known brain metastases, or with a history of cerebrospinal fluid malignant cells or brain metastases.\n 7.  History or presence of non-malignant CNS disorder such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement\n 8.  Presence of any indwelling line or drain. Dedicated central venous access catheter such as a Port-a-Cath or Hickman catheter are permitted.\n 9.  History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, New York Heart Association Class II or greater congestive heart failure, or other clinically significant cardiac diseases within 12 months of enrollment\n 10. History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months of enrollment\n 11. History of autoimmune disease, requiring systemic immunosuppression and/or systemic disease modifying agents within the last 2 years\n 12. History of anti-CD19 or CAR-T therapy or history of prior randomization in ZUMA-7",{"$nulls":4},"Actual","2018-01-05","Actual","Anticipated","2035-01-15","Anticipated","2018-04-01","2017-12-21","2017-12-29","2018-04-04","Yes",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No","Yes",{"$nulls":3},"Yes","No",{"$nulls":19},"Event Free Survival","3 years",null,"Objective Response Rate|Overall Survival","3 years|4 years",null,"medinfo@kitepharma.com","Kite MD",-6780,"Stanford, California, United States, 94305|Tampa, Florida, United States, 12902|Chicago, Illinois, United States, 60637|Boston, Massachusetts, United States, 02215|Rochester, Minnesota, United States, 55905|Saint Louis, Missouri, United States, 63130|Nashville, Tennessee, United States, 37203|Houston, Texas, United States, 77030","California|Florida|Illinois|Massachusetts|Minnesota|Missouri|Tennessee|Texas","United States","Stanford University|Moffitt Cancer Center|University Of Chicago|Dana-Farber Cancer Institute|Mayo Clinic|Washington University|Sarah Cannon Research Institute|Md Anderson Cancer Center",{"$nulls":4},"2018-04-04","2020-05-25T16:35:18.783","2020-05-26T17:10:42.972","NCT03391466"]
["5ecbf3c6feab101b155307d9","NCT03391466","2018-04-11","Gilead Sciences","GILD","Recruiting","A Study Evaluating the Efficacy of Axicabtagene Ciloleucel Compared to Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma (ZUMA-7)","Axicabtagene ciloleucel|Autologous stem cell transplant","CAR-T|Autologous Cell Therapy","Yes","['Axicabtagene ciloleucel']","Yes","['CAR-T', 'Autologous Cell Therapy']","Phase 3",2,350,"Anticipated","2017-12-14","2022-01-15","EFS","Event Free Survival",{"$nulls":3},"The purpose of this study is to evaluate whether axicabtagene ciloleucel therapy improves the clinical outcome compared with standard of care second-line therapy in patients with relapsed/refractory DLBCL.","This is a phase 3 randomized, open-label, multicenter study evaluating the efficacy of axicabtagene ciloleucel versus standard of care therapy in subjects with relapsed/refractory DLBCL. Adult subjects with relapsed/refractory DLBCL after first-line rituximab and anthracycline-based chemotherapy will be randomized in a 1:1 ratio to receive axicabtagene ciloleucel or standard of care second-line therapy.\n\nStandard of care will consist of a protocol-defined, platinum-based salvage combination chemotherapy regimen followed by high-dose therapy and autologous stem cell transplant in those who respond to salvage chemotherapy.","A Phase 3, Randomized, Open-Label Study Evaluating Efficacy of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma","KTE-C19-107","Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)","Diffuse Large B-Cell Lymphoma|Lymphoma|Lymphoma, B-Cell","Oncology Hematological","Oncology","Experimental|Active Comparator","Axicabtagene Ciloleucel Treatment|Standard of Care Therapy",null,"Drug","Axicabtagene Ciloleucel|Platinum-containing salvage chemotherapy (eg, R-ICE) followed by high dose therapy (eg, BEAM) and autologous stem cell transplant in responders.","Intervention Description: N/A.","KTE-C19 | axi-cel","Axicabtagene Ciloleucel Treatment|Standard of Care Therapy","\n\n 1. Histologically proven DLBCL, including transformation from follicular lymphoma\n 2. Relapsed or refractory disease after first-line chemoimmunotherapy * Refractory disease is defined as no complete remission to first-line therapy; subjects who are intolerant to first-line therapy are excluded. * Progressive disease (PD) as best response to first-line therapy\n        * Stable disease (SD) as best response after at least 4 cycles of first-line therapy\n        * Partial response (PR) as best response after at least 6 cycles and biopsy-proven residual disease or disease progression â‰¤ 12 months from initiation of therapy\n       \n       \n     * Relapsed disease defined as complete remission to first-line therapy followed by biopsy-proven relapse â‰¤ 12 months of initiating first-line therapy\n    \n    \n 3. Subjects must have received adequate first-line therapy including at a minimum: * Anti-CD20 monoclonal antibody unless investigator determines that tumor is CD20 negative, and\n     * An anthracycline containing chemotherapy regimen\n    \n    \n 4. No known history or suspicion of central nervous system involvement by lymphoma\n 5. ECOG performance status of 0 or 1\n 6. Adequate bone marrow function as evidenced by: * ANC â‰¥ 1000/uL\n     * Platelet â‰¥ 75,000/uL\n     * Absolute lymphocyte count â‰¥ 100/uL\n    \n    \n 7. Adequate renal, hepatic, cardiac, and pulmonary function as evidenced by: * Creatinine clearance (Cockcroft Gault) â‰¥ 60 mL/min\n     * Serum ALT/AST â‰¤ 2.5 ULN\n     * Total bilirubin â‰¤ 1.5 mg/dl\n     * Cardiac ejection fraction â‰¥ 50%, no evidence of pericardial effusion as determined by an ECHO, and no clinically significant ECG findings\n     * No clinically significant pleural effusion\n     * Baseline oxygen saturation > 92% on room air\n    \n    \n\nKey ","\n\n 1.  History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (eg cervix, bladder, breast) unless disease free for at least 3 years\n 2.  Received more than one line of therapy for DLBCL\n 3.  History of autologous or allogeneic stem cell transplant\n 4.  Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring intravenous antimicrobials for management.\n 5.  Known history of infection with human immunodeficiency virus (HIV) or hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive). If there is a positive history of treated hepatitis B or hepatitis C, the viral load must be undetectable per quantitative polymerase chain reaction (PCR) and/or nucleic acid testing.\n 6.  Subjects with detectable cerebrospinal fluid malignant cells or known brain metastases, or with a history of cerebrospinal fluid malignant cells or brain metastases.\n 7.  History or presence of non-malignant CNS disorder such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement\n 8.  Presence of any indwelling line or drain. Dedicated central venous access catheter such as a Port-a-Cath or Hickman catheter are permitted.\n 9.  History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, New York Heart Association Class II or greater congestive heart failure, or other clinically significant cardiac diseases within 12 months of enrollment\n 10. History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months of enrollment\n 11. History of autoimmune disease, requiring systemic immunosuppression and/or systemic disease modifying agents within the last 2 years\n 12. History of anti-CD19 or CAR-T therapy or history of prior randomization in ZUMA-7",{"$nulls":4},"Actual","2018-01-05","Actual","Anticipated","2035-01-15","Anticipated","2018-04-01","2017-12-21","2017-12-29","2018-04-10","Yes",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No","Yes",{"$nulls":3},"Yes","No",{"$nulls":19},"Event Free Survival","3 years",null,"Objective Response Rate|Overall Survival","3 years|4 years",null,"medinfo@kitepharma.com","Kite MD",-6780,"Stanford, California, United States, 94305|Tampa, Florida, United States, 12902|Chicago, Illinois, United States, 60637|Boston, Massachusetts, United States, 02215|Rochester, Minnesota, United States, 55905|Saint Louis, Missouri, United States, 63130|Nashville, Tennessee, United States, 37203|Houston, Texas, United States, 77030","California|Florida|Illinois|Massachusetts|Minnesota|Missouri|Tennessee|Texas","United States","Stanford University|Moffitt Cancer Center|University Of Chicago|Dana-Farber Cancer Institute|Mayo Clinic|Washington University|Sarah Cannon Research Institute|Md Anderson Cancer Center",{"$nulls":4},"2018-04-10","2020-05-25T16:35:18.427","2020-05-26T17:10:42.972","NCT03391466"]
["5ecbf3c6e2561b1b11905ca5","NCT03391466","2018-05-01","Gilead Sciences","GILD","Recruiting","A Study Evaluating the Efficacy of Axicabtagene Ciloleucel Compared to Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma (ZUMA-7)","Axicabtagene ciloleucel|Autologous stem cell transplant","CAR-T|Autologous Cell Therapy","Yes","['Axicabtagene ciloleucel']","Yes","['CAR-T', 'Autologous Cell Therapy']","Phase 3",2,350,"Anticipated","2017-12-14","2022-01-15","EFS","Event Free Survival",{"$nulls":3},"The purpose of this study is to evaluate whether axicabtagene ciloleucel therapy improves the clinical outcome compared with standard of care second-line therapy in patients with relapsed/refractory DLBCL.","This is a phase 3 randomized, open-label, multicenter study evaluating the efficacy of axicabtagene ciloleucel versus standard of care therapy in subjects with relapsed/refractory DLBCL. Adult subjects with relapsed/refractory DLBCL after first-line rituximab and anthracycline-based chemotherapy will be randomized in a 1:1 ratio to receive axicabtagene ciloleucel or standard of care second-line therapy.\n\nStandard of care will consist of a protocol-defined, platinum-based salvage combination chemotherapy regimen followed by high-dose therapy and autologous stem cell transplant in those who respond to salvage chemotherapy.","A Phase 3, Randomized, Open-Label Study Evaluating Efficacy of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma","KTE-C19-107","Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)","Diffuse Large B-Cell Lymphoma|Lymphoma|Lymphoma, B-Cell","Oncology Hematological","Oncology","Experimental|Active Comparator","Axicabtagene Ciloleucel Treatment|Standard of Care Therapy",null,"Drug","Axicabtagene Ciloleucel|Platinum-containing salvage chemotherapy (eg, R-ICE) followed by high dose therapy (eg, BEAM) and autologous stem cell transplant in responders.","Intervention Description: N/A.","KTE-C19 | axi-cel","Axicabtagene Ciloleucel Treatment|Standard of Care Therapy","\n\n 1. Histologically proven DLBCL, including transformation from follicular lymphoma\n 2. Relapsed or refractory disease after first-line chemoimmunotherapy * Refractory disease is defined as no complete remission to first-line therapy; subjects who are intolerant to first-line therapy are excluded. * Progressive disease (PD) as best response to first-line therapy\n        * Stable disease (SD) as best response after at least 4 cycles of first-line therapy\n        * Partial response (PR) as best response after at least 6 cycles and biopsy-proven residual disease or disease progression â‰¤ 12 months from initiation of therapy\n       \n       \n     * Relapsed disease defined as complete remission to first-line therapy followed by biopsy-proven relapse â‰¤ 12 months of initiating first-line therapy\n    \n    \n 3. Subjects must have received adequate first-line therapy including at a minimum: * Anti-CD20 monoclonal antibody unless investigator determines that tumor is CD20 negative, and\n     * An anthracycline containing chemotherapy regimen\n    \n    \n 4. No known history or suspicion of central nervous system involvement by lymphoma\n 5. ECOG performance status of 0 or 1\n 6. Adequate bone marrow function as evidenced by: * ANC â‰¥ 1000/uL\n     * Platelet â‰¥ 75,000/uL\n     * Absolute lymphocyte count â‰¥ 100/uL\n    \n    \n 7. Adequate renal, hepatic, cardiac, and pulmonary function as evidenced by: * Creatinine clearance (Cockcroft Gault) â‰¥ 60 mL/min\n     * Serum ALT/AST â‰¤ 2.5 ULN\n     * Total bilirubin â‰¤ 1.5 mg/dl\n     * Cardiac ejection fraction â‰¥ 50%, no evidence of pericardial effusion as determined by an ECHO, and no clinically significant ECG findings\n     * No clinically significant pleural effusion\n     * Baseline oxygen saturation > 92% on room air\n    \n    \n\nKey ","\n\n 1.  History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (eg cervix, bladder, breast) unless disease free for at least 3 years\n 2.  Received more than one line of therapy for DLBCL\n 3.  History of autologous or allogeneic stem cell transplant\n 4.  Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring intravenous antimicrobials for management.\n 5.  Known history of infection with human immunodeficiency virus (HIV) or hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive). If there is a positive history of treated hepatitis B or hepatitis C, the viral load must be undetectable per quantitative polymerase chain reaction (PCR) and/or nucleic acid testing.\n 6.  Subjects with detectable cerebrospinal fluid malignant cells or known brain metastases, or with a history of cerebrospinal fluid malignant cells or brain metastases.\n 7.  History or presence of non-malignant CNS disorder such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement\n 8.  Presence of any indwelling line or drain. Dedicated central venous access catheter such as a Port-a-Cath or Hickman catheter are permitted.\n 9.  History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, New York Heart Association Class II or greater congestive heart failure, or other clinically significant cardiac diseases within 12 months of enrollment\n 10. History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months of enrollment\n 11. History of autoimmune disease, requiring systemic immunosuppression and/or systemic disease modifying agents within the last 2 years\n 12. History of anti-CD19 or CAR-T therapy or history of prior randomization in ZUMA-7",{"$nulls":4},"Actual","2018-01-05","Actual","Anticipated","2035-01-15","Anticipated","2018-04-01","2017-12-21","2017-12-29","2018-04-30","Yes",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No","Yes",{"$nulls":3},"Yes","No",{"$nulls":19},"Event Free Survival","3 years",null,"Objective Response Rate|Overall Survival","3 years|4 years",null,"medinfo@kitepharma.com","Kite MD",-6780,"Stanford, California, United States, 94305|Tampa, Florida, United States, 12902|Chicago, Illinois, United States, 60637|Iowa City, Iowa, United States, 52242|Boston, Massachusetts, United States, 02215|Rochester, Minnesota, United States, 55905|Saint Louis, Missouri, United States, 63130|Nashville, Tennessee, United States, 37203|Houston, Texas, United States, 77030","California|Florida|Illinois|Iowa|Massachusetts|Minnesota|Missouri|Tennessee|Texas","United States","Stanford University|Moffitt Cancer Center|University Of Chicago|University Of Iowa|Dana-Farber Cancer Institute|Mayo Clinic|Washington University|Sarah Cannon Research Institute|Md Anderson Cancer Center",{"$nulls":4},"2018-04-30","2020-05-25T16:35:18.488","2020-05-26T17:10:42.972","NCT03391466"]
["5ecbf3c6fe30261b1a0481aa","NCT03391466","2018-05-14","Gilead Sciences","GILD","Recruiting","A Study Evaluating the Efficacy of Axicabtagene Ciloleucel Compared to Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma (ZUMA-7)","Axicabtagene ciloleucel|Autologous stem cell transplant","CAR-T|Autologous Cell Therapy","Yes","['Axicabtagene ciloleucel']","Yes","['CAR-T', 'Autologous Cell Therapy']","Phase 3",2,350,"Anticipated","2017-12-14","2022-01-15","EFS","Event Free Survival",{"$nulls":3},"The purpose of this study is to evaluate whether axicabtagene ciloleucel therapy improves the clinical outcome compared with standard of care second-line therapy in patients with relapsed/refractory DLBCL.","This is a phase 3 randomized, open-label, multicenter study evaluating the efficacy of axicabtagene ciloleucel versus standard of care therapy in subjects with relapsed/refractory DLBCL. Adult subjects with relapsed/refractory DLBCL after first-line rituximab and anthracycline-based chemotherapy will be randomized in a 1:1 ratio to receive axicabtagene ciloleucel or standard of care second-line therapy.\n\nStandard of care will consist of a protocol-defined, platinum-based salvage combination chemotherapy regimen followed by high-dose therapy and autologous stem cell transplant in those who respond to salvage chemotherapy.","A Phase 3, Randomized, Open-Label Study Evaluating Efficacy of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma","KTE-C19-107","Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)","Diffuse Large B-Cell Lymphoma|Lymphoma|Lymphoma, B-Cell","Oncology Hematological","Oncology","Experimental|Active Comparator","Axicabtagene Ciloleucel Treatment|Standard of Care Therapy",null,"Drug","Axicabtagene Ciloleucel|Platinum-containing salvage chemotherapy (eg, R-ICE) followed by high dose therapy (eg, BEAM) and autologous stem cell transplant in responders.","Intervention Description: N/A.","KTE-C19 | axi-cel","Axicabtagene Ciloleucel Treatment|Standard of Care Therapy","\n\n 1. Histologically proven DLBCL, including transformation from follicular lymphoma\n 2. Relapsed or refractory disease after first-line chemoimmunotherapy * Refractory disease is defined as no complete remission to first-line therapy; subjects who are intolerant to first-line therapy are excluded. * Progressive disease (PD) as best response to first-line therapy\n        * Stable disease (SD) as best response after at least 4 cycles of first-line therapy\n        * Partial response (PR) as best response after at least 6 cycles and biopsy-proven residual disease or disease progression â‰¤ 12 months from initiation of therapy\n       \n       \n     * Relapsed disease defined as complete remission to first-line therapy followed by biopsy-proven relapse â‰¤ 12 months of initiating first-line therapy\n    \n    \n 3. Subjects must have received adequate first-line therapy including at a minimum: * Anti-CD20 monoclonal antibody unless investigator determines that tumor is CD20 negative, and\n     * An anthracycline containing chemotherapy regimen\n    \n    \n 4. No known history or suspicion of central nervous system involvement by lymphoma\n 5. ECOG performance status of 0 or 1\n 6. Adequate bone marrow function as evidenced by: * ANC â‰¥ 1000/uL\n     * Platelet â‰¥ 75,000/uL\n     * Absolute lymphocyte count â‰¥ 100/uL\n    \n    \n 7. Adequate renal, hepatic, cardiac, and pulmonary function as evidenced by: * Creatinine clearance (Cockcroft Gault) â‰¥ 60 mL/min\n     * Serum ALT/AST â‰¤ 2.5 ULN\n     * Total bilirubin â‰¤ 1.5 mg/dl\n     * Cardiac ejection fraction â‰¥ 50%, no evidence of pericardial effusion as determined by an ECHO, and no clinically significant ECG findings\n     * No clinically significant pleural effusion\n     * Baseline oxygen saturation > 92% on room air\n    \n    \n\nKey ","\n\n 1.  History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (eg cervix, bladder, breast) unless disease free for at least 3 years\n 2.  Received more than one line of therapy for DLBCL\n 3.  History of autologous or allogeneic stem cell transplant\n 4.  Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring intravenous antimicrobials for management.\n 5.  Known history of infection with human immunodeficiency virus (HIV) or hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive). If there is a positive history of treated hepatitis B or hepatitis C, the viral load must be undetectable per quantitative polymerase chain reaction (PCR) and/or nucleic acid testing.\n 6.  Subjects with detectable cerebrospinal fluid malignant cells or known brain metastases, or with a history of cerebrospinal fluid malignant cells or brain metastases.\n 7.  History or presence of non-malignant CNS disorder such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement\n 8.  Presence of any indwelling line or drain. Dedicated central venous access catheter such as a Port-a-Cath or Hickman catheter are permitted.\n 9.  History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, New York Heart Association Class II or greater congestive heart failure, or other clinically significant cardiac diseases within 12 months of enrollment\n 10. History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months of enrollment\n 11. History of autoimmune disease, requiring systemic immunosuppression and/or systemic disease modifying agents within the last 2 years\n 12. History of anti-CD19 or CAR-T therapy or history of prior randomization in ZUMA-7",{"$nulls":4},"Actual","2018-01-05","Actual","Anticipated","2035-01-15","Anticipated","2018-05-01","2017-12-21","2017-12-29","2018-05-10","Yes",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No","Yes",{"$nulls":3},"Yes","No",{"$nulls":19},"Event Free Survival","3 years",null,"Objective Response Rate|Overall Survival","3 years|4 years",null,"medinfo@kitepharma.com","Kite MD",-6780,"Gilbert, Arizona, United States, 85234|Stanford, California, United States, 94305|Tampa, Florida, United States, 12902|Chicago, Illinois, United States, 60637|Iowa City, Iowa, United States, 52242|Boston, Massachusetts, United States, 02215|Rochester, Minnesota, United States, 55905|Saint Louis, Missouri, United States, 63130|Nashville, Tennessee, United States, 37203|Houston, Texas, United States, 77030","Arizona|California|Florida|Illinois|Iowa|Massachusetts|Minnesota|Missouri|Tennessee|Texas","United States","Banner Md Anderson Cancer Center|Stanford University|Moffitt Cancer Center|University Of Chicago|University Of Iowa|Dana-Farber Cancer Institute|Mayo Clinic|Washington University|Sarah Cannon Research Institute|Md Anderson Cancer Center",{"$nulls":4},"2018-05-10","2020-05-25T16:35:18.783","2020-05-26T17:10:42.972","NCT03391466"]
["5ecbf3c6307e3d1b1f8d9c3a","NCT03391466","2018-05-21","Gilead Sciences","GILD","Recruiting","A Study Evaluating the Efficacy of Axicabtagene Ciloleucel Compared to Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma (ZUMA-7)","Axicabtagene ciloleucel|Autologous stem cell transplant","CAR-T|Autologous Cell Therapy","Yes","['Axicabtagene ciloleucel']","Yes","['CAR-T', 'Autologous Cell Therapy']","Phase 3",2,350,"Anticipated","2017-12-14","2022-01-15","EFS","Event Free Survival",{"$nulls":3},"The purpose of this study is to evaluate whether axicabtagene ciloleucel therapy improves the clinical outcome compared with standard of care second-line therapy in patients with relapsed/refractory DLBCL.","This is a phase 3 randomized, open-label, multicenter study evaluating the efficacy of axicabtagene ciloleucel versus standard of care therapy in subjects with relapsed/refractory DLBCL. Adult subjects with relapsed/refractory DLBCL after first-line rituximab and anthracycline-based chemotherapy will be randomized in a 1:1 ratio to receive axicabtagene ciloleucel or standard of care second-line therapy.\n\nStandard of care will consist of a protocol-defined, platinum-based salvage combination chemotherapy regimen followed by high-dose therapy and autologous stem cell transplant in those who respond to salvage chemotherapy.","A Phase 3, Randomized, Open-Label Study Evaluating Efficacy of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma","KTE-C19-107","Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)","Diffuse Large B-Cell Lymphoma|Lymphoma|Lymphoma, B-Cell","Oncology Hematological","Oncology","Experimental|Active Comparator","Axicabtagene Ciloleucel Treatment|Standard of Care Therapy",null,"Drug","Axicabtagene Ciloleucel|Platinum-containing salvage chemotherapy (eg, R-ICE) followed by high dose therapy (eg, BEAM) and autologous stem cell transplant in responders.","Intervention Description: N/A.","KTE-C19 | axi-cel","Axicabtagene Ciloleucel Treatment|Standard of Care Therapy","\n\n 1. Histologically proven DLBCL, including transformation from follicular lymphoma\n 2. Relapsed or refractory disease after first-line chemoimmunotherapy * Refractory disease is defined as no complete remission to first-line therapy; subjects who are intolerant to first-line therapy are excluded. * Progressive disease (PD) as best response to first-line therapy\n        * Stable disease (SD) as best response after at least 4 cycles of first-line therapy\n        * Partial response (PR) as best response after at least 6 cycles and biopsy-proven residual disease or disease progression â‰¤ 12 months from initiation of therapy\n       \n       \n     * Relapsed disease defined as complete remission to first-line therapy followed by biopsy-proven relapse â‰¤ 12 months of initiating first-line therapy\n    \n    \n 3. Subjects must have received adequate first-line therapy including at a minimum: * Anti-CD20 monoclonal antibody unless investigator determines that tumor is CD20 negative, and\n     * An anthracycline containing chemotherapy regimen\n    \n    \n 4. No known history or suspicion of central nervous system involvement by lymphoma\n 5. ECOG performance status of 0 or 1\n 6. Adequate bone marrow function as evidenced by: * ANC â‰¥ 1000/uL\n     * Platelet â‰¥ 75,000/uL\n     * Absolute lymphocyte count â‰¥ 100/uL\n    \n    \n 7. Adequate renal, hepatic, cardiac, and pulmonary function as evidenced by: * Creatinine clearance (Cockcroft Gault) â‰¥ 60 mL/min\n     * Serum ALT/AST â‰¤ 2.5 ULN\n     * Total bilirubin â‰¤ 1.5 mg/dl\n     * Cardiac ejection fraction â‰¥ 50%, no evidence of pericardial effusion as determined by an ECHO, and no clinically significant ECG findings\n     * No clinically significant pleural effusion\n     * Baseline oxygen saturation > 92% on room air\n    \n    \n\nKey ","\n\n 1.  History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (eg cervix, bladder, breast) unless disease free for at least 3 years\n 2.  Received more than one line of therapy for DLBCL\n 3.  History of autologous or allogeneic stem cell transplant\n 4.  Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring intravenous antimicrobials for management.\n 5.  Known history of infection with human immunodeficiency virus (HIV) or hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive). If there is a positive history of treated hepatitis B or hepatitis C, the viral load must be undetectable per quantitative polymerase chain reaction (PCR) and/or nucleic acid testing.\n 6.  Subjects with detectable cerebrospinal fluid malignant cells or known brain metastases, or with a history of cerebrospinal fluid malignant cells or brain metastases.\n 7.  History or presence of non-malignant CNS disorder such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement\n 8.  Presence of any indwelling line or drain. Dedicated central venous access catheter such as a Port-a-Cath or Hickman catheter are permitted.\n 9.  History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, New York Heart Association Class II or greater congestive heart failure, or other clinically significant cardiac diseases within 12 months of enrollment\n 10. History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months of enrollment\n 11. History of autoimmune disease, requiring systemic immunosuppression and/or systemic disease modifying agents within the last 2 years\n 12. History of anti-CD19 or CAR-T therapy or history of prior randomization in ZUMA-7",{"$nulls":4},"Actual","2018-01-05","Actual","Anticipated","2035-01-15","Anticipated","2018-05-01","2017-12-21","2017-12-29","2018-05-17","Yes",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No","Yes",{"$nulls":3},"Yes","No",{"$nulls":19},"Event Free Survival","3 years",null,"Objective Response Rate|Overall Survival","3 years|4 years",null,"medinfo@kitepharma.com","Kite MD",-6780,"Gilbert, Arizona, United States, 85234|Stanford, California, United States, 94305|Tampa, Florida, United States, 12902|Chicago, Illinois, United States, 60637|Iowa City, Iowa, United States, 52242|Boston, Massachusetts, United States, 02215|Rochester, Minnesota, United States, 55905|Saint Louis, Missouri, United States, 63130|Pittsburgh, Pennsylvania, United States, 15213|Nashville, Tennessee, United States, 37203|Houston, Texas, United States, 77030","Arizona|California|Florida|Illinois|Iowa|Massachusetts|Minnesota|Missouri|Pennsylvania|Tennessee|Texas","United States","Banner Md Anderson Cancer Center|Stanford University|Moffitt Cancer Center|University Of Chicago|University Of Iowa|Dana-Farber Cancer Institute|Mayo Clinic|Washington University|University Of Pittsburgh Medical Center|Sarah Cannon Research Institute|Md Anderson Cancer Center",{"$nulls":4},"2018-05-17","2020-05-25T16:35:18.781","2020-05-26T17:10:42.972","NCT03391466"]
["5ecbf3c6e2561b1b11905ca6","NCT03391466","2018-05-31","Gilead Sciences","GILD","Recruiting","A Study Evaluating the Efficacy of Axicabtagene Ciloleucel Compared to Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma (ZUMA-7)","Axicabtagene ciloleucel|Autologous stem cell transplant","CAR-T|Autologous Cell Therapy","Yes","['Axicabtagene ciloleucel']","Yes","['CAR-T', 'Autologous Cell Therapy']","Phase 3",2,350,"Anticipated","2017-12-14","2022-01-15","EFS","Event Free Survival",{"$nulls":3},"The purpose of this study is to evaluate whether axicabtagene ciloleucel therapy improves the clinical outcome compared with standard of care second-line therapy in patients with relapsed/refractory DLBCL.","This is a phase 3 randomized, open-label, multicenter study evaluating the efficacy of axicabtagene ciloleucel versus standard of care therapy in subjects with relapsed/refractory DLBCL. Adult subjects with relapsed/refractory DLBCL after first-line rituximab and anthracycline-based chemotherapy will be randomized in a 1:1 ratio to receive axicabtagene ciloleucel or standard of care second-line therapy.\n\nStandard of care will consist of a protocol-defined, platinum-based salvage combination chemotherapy regimen followed by high-dose therapy and autologous stem cell transplant in those who respond to salvage chemotherapy.","A Phase 3, Randomized, Open-Label Study Evaluating Efficacy of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma","KTE-C19-107","Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)","Diffuse Large B-Cell Lymphoma|Lymphoma|Lymphoma, B-Cell","Oncology Hematological","Oncology","Experimental|Active Comparator","Axicabtagene Ciloleucel Treatment|Standard of Care Therapy",null,"Drug","Axicabtagene Ciloleucel|Platinum-containing salvage chemotherapy (eg, R-ICE) followed by high dose therapy (eg, BEAM) and autologous stem cell transplant in responders.","Intervention Description: N/A.","KTE-C19 | axi-cel","Axicabtagene Ciloleucel Treatment|Standard of Care Therapy","\n\n 1. Histologically proven DLBCL, including transformation from follicular lymphoma\n 2. Relapsed or refractory disease after first-line chemoimmunotherapy * Refractory disease is defined as no complete remission to first-line therapy; subjects who are intolerant to first-line therapy are excluded. * Progressive disease (PD) as best response to first-line therapy\n        * Stable disease (SD) as best response after at least 4 cycles of first-line therapy\n        * Partial response (PR) as best response after at least 6 cycles and biopsy-proven residual disease or disease progression â‰¤ 12 months from initiation of therapy\n       \n       \n     * Relapsed disease defined as complete remission to first-line therapy followed by biopsy-proven relapse â‰¤ 12 months of initiating first-line therapy\n    \n    \n 3. Subjects must have received adequate first-line therapy including at a minimum: * Anti-CD20 monoclonal antibody unless investigator determines that tumor is CD20 negative, and\n     * An anthracycline containing chemotherapy regimen\n    \n    \n 4. No known history or suspicion of central nervous system involvement by lymphoma\n 5. ECOG performance status of 0 or 1\n 6. Adequate bone marrow function as evidenced by: * ANC â‰¥ 1000/uL\n     * Platelet â‰¥ 75,000/uL\n     * Absolute lymphocyte count â‰¥ 100/uL\n    \n    \n 7. Adequate renal, hepatic, cardiac, and pulmonary function as evidenced by: * Creatinine clearance (Cockcroft Gault) â‰¥ 60 mL/min\n     * Serum ALT/AST â‰¤ 2.5 ULN\n     * Total bilirubin â‰¤ 1.5 mg/dl\n     * Cardiac ejection fraction â‰¥ 50%, no evidence of pericardial effusion as determined by an ECHO, and no clinically significant ECG findings\n     * No clinically significant pleural effusion\n     * Baseline oxygen saturation > 92% on room air\n    \n    \n\nKey ","\n\n 1.  History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (eg cervix, bladder, breast) unless disease free for at least 3 years\n 2.  Received more than one line of therapy for DLBCL\n 3.  History of autologous or allogeneic stem cell transplant\n 4.  Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring intravenous antimicrobials for management.\n 5.  Known history of infection with human immunodeficiency virus (HIV) or hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive). If there is a positive history of treated hepatitis B or hepatitis C, the viral load must be undetectable per quantitative polymerase chain reaction (PCR) and/or nucleic acid testing.\n 6.  Subjects with detectable cerebrospinal fluid malignant cells or known brain metastases, or with a history of cerebrospinal fluid malignant cells or brain metastases.\n 7.  History or presence of non-malignant CNS disorder such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement\n 8.  Presence of any indwelling line or drain. Dedicated central venous access catheter such as a Port-a-Cath or Hickman catheter are permitted.\n 9.  History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, New York Heart Association Class II or greater congestive heart failure, or other clinically significant cardiac diseases within 12 months of enrollment\n 10. History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months of enrollment\n 11. History of autoimmune disease, requiring systemic immunosuppression and/or systemic disease modifying agents within the last 2 years\n 12. History of anti-CD19 or CAR-T therapy or history of prior randomization in ZUMA-7",{"$nulls":4},"Actual","2018-01-05","Actual","Anticipated","2035-01-15","Anticipated","2018-05-01","2017-12-21","2017-12-29","2018-05-29","Yes",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No","Yes",{"$nulls":3},"Yes","No",{"$nulls":19},"Event Free Survival","3 years",null,"Objective Response Rate|Overall Survival","3 years|4 years",null,"medinfo@kitepharma.com","Kite MD",-6780,"Gilbert, Arizona, United States, 85234|Stanford, California, United States, 94305|Tampa, Florida, United States, 12902|Chicago, Illinois, United States, 60637|Iowa City, Iowa, United States, 52242|Boston, Massachusetts, United States, 02215|Rochester, Minnesota, United States, 55905|Saint Louis, Missouri, United States, 63130|Columbus, Ohio, United States, 43210|Pittsburgh, Pennsylvania, United States, 15213|Nashville, Tennessee, United States, 37203|Houston, Texas, United States, 77030","Arizona|California|Florida|Illinois|Iowa|Massachusetts|Minnesota|Missouri|Ohio|Pennsylvania|Tennessee|Texas","United States","Banner Md Anderson Cancer Center|Stanford University|Moffitt Cancer Center|University Of Chicago|University Of Iowa|Dana-Farber Cancer Institute|Mayo Clinic|Washington University|The Ohio State University|University Of Pittsburgh Medical Center|Sarah Cannon Research Institute|Md Anderson Cancer Center",{"$nulls":4},"2018-05-29","2020-05-25T16:35:18.861","2020-05-26T17:10:42.972","NCT03391466"]
["5ecbf3c6fe30261b1a0481ab","NCT03391466","2018-06-12","Gilead Sciences","GILD","Recruiting","A Study Evaluating the Efficacy of Axicabtagene Ciloleucel Compared to Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma (ZUMA-7)","Axicabtagene ciloleucel|Autologous stem cell transplant","CAR-T|Autologous Cell Therapy","Yes","['Axicabtagene ciloleucel']","Yes","['CAR-T', 'Autologous Cell Therapy']","Phase 3",2,350,"Anticipated","2017-12-14","2022-01-15","EFS","Event Free Survival",{"$nulls":3},"The purpose of this study is to evaluate whether axicabtagene ciloleucel therapy improves the clinical outcome compared with standard of care second-line therapy in patients with relapsed/refractory DLBCL.","This is a phase 3 randomized, open-label, multicenter study evaluating the efficacy of axicabtagene ciloleucel versus standard of care therapy in subjects with relapsed/refractory DLBCL. Adult subjects with relapsed/refractory DLBCL after first-line rituximab and anthracycline-based chemotherapy will be randomized in a 1:1 ratio to receive axicabtagene ciloleucel or standard of care second-line therapy.\n\nStandard of care will consist of a protocol-defined, platinum-based salvage combination chemotherapy regimen followed by high-dose therapy and autologous stem cell transplant in those who respond to salvage chemotherapy.","A Phase 3, Randomized, Open-Label Study Evaluating Efficacy of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma","KTE-C19-107","Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)","Diffuse Large B-Cell Lymphoma|Lymphoma|Lymphoma, B-Cell","Oncology Hematological","Oncology","Experimental|Active Comparator","Axicabtagene Ciloleucel Treatment|Standard of Care Therapy",null,"Drug","Axicabtagene Ciloleucel|Platinum-containing salvage chemotherapy (eg, R-ICE) followed by high dose therapy (eg, BEAM) and autologous stem cell transplant in responders.","Intervention Description: N/A.","KTE-C19 | axi-cel","Axicabtagene Ciloleucel Treatment|Standard of Care Therapy","\n\n 1. Histologically proven DLBCL, including transformation from follicular lymphoma\n 2. Relapsed or refractory disease after first-line chemoimmunotherapy * Refractory disease is defined as no complete remission to first-line therapy; subjects who are intolerant to first-line therapy are excluded. * Progressive disease (PD) as best response to first-line therapy\n        * Stable disease (SD) as best response after at least 4 cycles of first-line therapy\n        * Partial response (PR) as best response after at least 6 cycles and biopsy-proven residual disease or disease progression â‰¤ 12 months from initiation of therapy\n       \n       \n     * Relapsed disease defined as complete remission to first-line therapy followed by biopsy-proven relapse â‰¤ 12 months of initiating first-line therapy\n    \n    \n 3. Subjects must have received adequate first-line therapy including at a minimum: * Anti-CD20 monoclonal antibody unless investigator determines that tumor is CD20 negative, and\n     * An anthracycline containing chemotherapy regimen\n    \n    \n 4. No known history or suspicion of central nervous system involvement by lymphoma\n 5. ECOG performance status of 0 or 1\n 6. Adequate bone marrow function as evidenced by: * ANC â‰¥ 1000/uL\n     * Platelet â‰¥ 75,000/uL\n     * Absolute lymphocyte count â‰¥ 100/uL\n    \n    \n 7. Adequate renal, hepatic, cardiac, and pulmonary function as evidenced by: * Creatinine clearance (Cockcroft Gault) â‰¥ 60 mL/min\n     * Serum ALT/AST â‰¤ 2.5 ULN\n     * Total bilirubin â‰¤ 1.5 mg/dl\n     * Cardiac ejection fraction â‰¥ 50%, no evidence of pericardial effusion as determined by an ECHO, and no clinically significant ECG findings\n     * No clinically significant pleural effusion\n     * Baseline oxygen saturation > 92% on room air\n    \n    \n\nKey ","\n\n 1.  History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (eg cervix, bladder, breast) unless disease free for at least 3 years\n 2.  Received more than one line of therapy for DLBCL\n 3.  History of autologous or allogeneic stem cell transplant\n 4.  Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring intravenous antimicrobials for management.\n 5.  Known history of infection with human immunodeficiency virus (HIV) or hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive). If there is a positive history of treated hepatitis B or hepatitis C, the viral load must be undetectable per quantitative polymerase chain reaction (PCR) and/or nucleic acid testing.\n 6.  Subjects with detectable cerebrospinal fluid malignant cells or known brain metastases, or with a history of cerebrospinal fluid malignant cells or brain metastases.\n 7.  History or presence of non-malignant CNS disorder such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement\n 8.  Presence of any indwelling line or drain. Dedicated central venous access catheter such as a Port-a-Cath or Hickman catheter are permitted.\n 9.  History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, New York Heart Association Class II or greater congestive heart failure, or other clinically significant cardiac diseases within 12 months of enrollment\n 10. History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months of enrollment\n 11. History of autoimmune disease, requiring systemic immunosuppression and/or systemic disease modifying agents within the last 2 years\n 12. History of anti-CD19 or CAR-T therapy or history of prior randomization in ZUMA-7",{"$nulls":4},"Actual","2018-01-05","Actual","Anticipated","2035-01-15","Anticipated","2018-06-01","2017-12-21","2017-12-29","2018-06-11","Yes",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No","Yes",{"$nulls":3},"Yes","No",{"$nulls":19},"Event Free Survival","3 years",null,"Objective Response Rate|Overall Survival","3 years|4 years",null,"medinfo@kitepharma.com","Kite MD",-6780,"Amsterdam, Netherlands, 1105 Az|Gilbert, Arizona, United States, 85234|Stanford, California, United States, 94305|Tampa, Florida, United States, 12902|Chicago, Illinois, United States, 60637|Iowa City, Iowa, United States, 52242|Kansas City, Kansas, United States, 66160|Boston, Massachusetts, United States, 02215|Rochester, Minnesota, United States, 55905|Saint Louis, Missouri, United States, 63130|Columbus, Ohio, United States, 43210|Pittsburgh, Pennsylvania, United States, 15213|Nashville, Tennessee, United States, 37203|Houston, Texas, United States, 77030","Arizona|California|Florida|Illinois|Iowa|Kansas|Massachusetts|Minnesota|Missouri|Ohio|Pennsylvania|Tennessee|Texas","Netherlands|United States","Academic Medical Center Amsterdam|Banner Md Anderson Cancer Center|Stanford University|Moffitt Cancer Center|University Of Chicago|University Of Iowa|University Of Kansas Medical Center|Dana-Farber Cancer Institute|Mayo Clinic|Washington University|The Ohio State University|University Of Pittsburgh Medical Center|Sarah Cannon Research Institute|Md Anderson Cancer Center",{"$nulls":4},"2018-06-11","2020-05-25T16:35:18.979","2020-05-26T17:10:42.972","NCT03391466"]
["5ecbf3c611702c1b1b9169be","NCT03391466","2018-06-13","Gilead Sciences","GILD","Recruiting","A Study Evaluating the Efficacy of Axicabtagene Ciloleucel Compared to Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma (ZUMA-7)","Axicabtagene ciloleucel|Autologous stem cell transplant","CAR-T|Autologous Cell Therapy","Yes","['Axicabtagene ciloleucel']","Yes","['CAR-T', 'Autologous Cell Therapy']","Phase 3",2,350,"Anticipated","2017-12-14","2022-01-15","EFS","Event Free Survival",{"$nulls":3},"The purpose of this study is to evaluate whether axicabtagene ciloleucel therapy improves the clinical outcome compared with standard of care second-line therapy in patients with relapsed/refractory DLBCL.","This is a phase 3 randomized, open-label, multicenter study evaluating the efficacy of axicabtagene ciloleucel versus standard of care therapy in subjects with relapsed/refractory DLBCL. Adult subjects with relapsed/refractory DLBCL after first-line rituximab and anthracycline-based chemotherapy will be randomized in a 1:1 ratio to receive axicabtagene ciloleucel or standard of care second-line therapy.\n\nStandard of care will consist of a protocol-defined, platinum-based salvage combination chemotherapy regimen followed by high-dose therapy and autologous stem cell transplant in those who respond to salvage chemotherapy.","A Phase 3, Randomized, Open-Label Study Evaluating Efficacy of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma","KTE-C19-107","Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)","Diffuse Large B-Cell Lymphoma|Lymphoma|Lymphoma, B-Cell","Oncology Hematological","Oncology","Experimental|Active Comparator","Axicabtagene Ciloleucel Treatment|Standard of Care Therapy",null,"Drug","Axicabtagene Ciloleucel|Platinum-containing salvage chemotherapy (eg, R-ICE) followed by high dose therapy (eg, BEAM) and autologous stem cell transplant in responders.","Intervention Description: N/A.","KTE-C19 | axi-cel","Axicabtagene Ciloleucel Treatment|Standard of Care Therapy","\n\n 1. Histologically proven DLBCL, including transformation from follicular lymphoma\n 2. Relapsed or refractory disease after first-line chemoimmunotherapy * Refractory disease is defined as no complete remission to first-line therapy; subjects who are intolerant to first-line therapy are excluded. * Progressive disease (PD) as best response to first-line therapy\n        * Stable disease (SD) as best response after at least 4 cycles of first-line therapy\n        * Partial response (PR) as best response after at least 6 cycles and biopsy-proven residual disease or disease progression â‰¤ 12 months from initiation of therapy\n       \n       \n     * Relapsed disease defined as complete remission to first-line therapy followed by biopsy-proven relapse â‰¤ 12 months of initiating first-line therapy\n    \n    \n 3. Subjects must have received adequate first-line therapy including at a minimum: * Anti-CD20 monoclonal antibody unless investigator determines that tumor is CD20 negative, and\n     * An anthracycline containing chemotherapy regimen\n    \n    \n 4. No known history or suspicion of central nervous system involvement by lymphoma\n 5. ECOG performance status of 0 or 1\n 6. Adequate bone marrow function as evidenced by: * ANC â‰¥ 1000/uL\n     * Platelet â‰¥ 75,000/uL\n     * Absolute lymphocyte count â‰¥ 100/uL\n    \n    \n 7. Adequate renal, hepatic, cardiac, and pulmonary function as evidenced by: * Creatinine clearance (Cockcroft Gault) â‰¥ 60 mL/min\n     * Serum ALT/AST â‰¤ 2.5 ULN\n     * Total bilirubin â‰¤ 1.5 mg/dl\n     * Cardiac ejection fraction â‰¥ 50%, no evidence of pericardial effusion as determined by an ECHO, and no clinically significant ECG findings\n     * No clinically significant pleural effusion\n     * Baseline oxygen saturation > 92% on room air\n    \n    \n\nKey ","\n\n 1.  History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (eg cervix, bladder, breast) unless disease free for at least 3 years\n 2.  Received more than one line of therapy for DLBCL\n 3.  History of autologous or allogeneic stem cell transplant\n 4.  Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring intravenous antimicrobials for management.\n 5.  Known history of infection with human immunodeficiency virus (HIV) or hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive). If there is a positive history of treated hepatitis B or hepatitis C, the viral load must be undetectable per quantitative polymerase chain reaction (PCR) and/or nucleic acid testing.\n 6.  Subjects with detectable cerebrospinal fluid malignant cells or known brain metastases, or with a history of cerebrospinal fluid malignant cells or brain metastases.\n 7.  History or presence of non-malignant CNS disorder such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement\n 8.  Presence of any indwelling line or drain. Dedicated central venous access catheter such as a Port-a-Cath or Hickman catheter are permitted.\n 9.  History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, New York Heart Association Class II or greater congestive heart failure, or other clinically significant cardiac diseases within 12 months of enrollment\n 10. History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months of enrollment\n 11. History of autoimmune disease, requiring systemic immunosuppression and/or systemic disease modifying agents within the last 2 years\n 12. History of anti-CD19 or CAR-T therapy or history of prior randomization in ZUMA-7",{"$nulls":4},"Actual","2018-01-05","Actual","Anticipated","2035-01-15","Anticipated","2018-06-01","2017-12-21","2017-12-29","2018-06-11","Yes",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No","Yes",{"$nulls":3},"Yes","No",{"$nulls":19},"Event Free Survival","3 years",null,"Objective Response Rate|Overall Survival","3 years|4 years",null,"medinfo@kitepharma.com","Kite MD",-6780,"Amsterdam, Netherlands, 1105 Az|Gilbert, Arizona, United States, 85234|Stanford, California, United States, 94305|Tampa, Florida, United States, 12902|Chicago, Illinois, United States, 60637|Iowa City, Iowa, United States, 52242|Kansas City, Kansas, United States, 66160|Boston, Massachusetts, United States, 02215|Rochester, Minnesota, United States, 55905|Saint Louis, Missouri, United States, 63130|Columbus, Ohio, United States, 43210|Pittsburgh, Pennsylvania, United States, 15213|Nashville, Tennessee, United States, 37203|Houston, Texas, United States, 77030","Arizona|California|Florida|Illinois|Iowa|Kansas|Massachusetts|Minnesota|Missouri|Ohio|Pennsylvania|Tennessee|Texas","Netherlands|United States","Academic Medical Center Amsterdam|Banner Md Anderson Cancer Center|Stanford University|Moffitt Cancer Center|University Of Chicago|University Of Iowa|University Of Kansas Medical Center|Dana-Farber Cancer Institute|Mayo Clinic|Washington University|The Ohio State University|University Of Pittsburgh Medical Center|Sarah Cannon Research Institute|Md Anderson Cancer Center",{"$nulls":4},"2018-06-11","2020-05-25T16:35:18.961","2020-05-26T17:10:42.972","NCT03391466"]
["5ecbf3c711702c1b1b9169bf","NCT03391466","2018-06-15","Gilead Sciences","GILD","Recruiting","A Study Evaluating the Efficacy of Axicabtagene Ciloleucel Compared to Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma (ZUMA-7)","Axicabtagene ciloleucel|Autologous stem cell transplant","CAR-T|Autologous Cell Therapy","Yes","['Axicabtagene ciloleucel']","Yes","['CAR-T', 'Autologous Cell Therapy']","Phase 3",2,350,"Anticipated","2017-12-14","2022-01-15","EFS","Event Free Survival",{"$nulls":3},"The purpose of this study is to evaluate whether axicabtagene ciloleucel therapy improves the clinical outcome compared with standard of care second-line therapy in patients with relapsed/refractory DLBCL.","This is a phase 3 randomized, open-label, multicenter study evaluating the efficacy of axicabtagene ciloleucel versus standard of care therapy in subjects with relapsed/refractory DLBCL. Adult subjects with relapsed/refractory DLBCL after first-line rituximab and anthracycline-based chemotherapy will be randomized in a 1:1 ratio to receive axicabtagene ciloleucel or standard of care second-line therapy.\n\nStandard of care will consist of a protocol-defined, platinum-based salvage combination chemotherapy regimen followed by high-dose therapy and autologous stem cell transplant in those who respond to salvage chemotherapy.","A Phase 3, Randomized, Open-Label Study Evaluating Efficacy of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma","KTE-C19-107","Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)","Diffuse Large B-Cell Lymphoma|Lymphoma|Lymphoma, B-Cell","Oncology Hematological","Oncology","Experimental|Active Comparator","Axicabtagene Ciloleucel Treatment|Standard of Care Therapy",null,"Drug","Axicabtagene Ciloleucel|Platinum-containing salvage chemotherapy (eg, R-ICE) followed by high dose therapy (eg, BEAM) and autologous stem cell transplant in responders.","Intervention Description: N/A.","KTE-C19 | axi-cel","Axicabtagene Ciloleucel Treatment|Standard of Care Therapy","\n\n 1. Histologically proven DLBCL, including transformation from follicular lymphoma\n 2. Relapsed or refractory disease after first-line chemoimmunotherapy * Refractory disease is defined as no complete remission to first-line therapy; subjects who are intolerant to first-line therapy are excluded. * Progressive disease (PD) as best response to first-line therapy\n        * Stable disease (SD) as best response after at least 4 cycles of first-line therapy\n        * Partial response (PR) as best response after at least 6 cycles and biopsy-proven residual disease or disease progression â‰¤ 12 months from initiation of therapy\n       \n       \n     * Relapsed disease defined as complete remission to first-line therapy followed by biopsy-proven relapse â‰¤ 12 months of initiating first-line therapy\n    \n    \n 3. Subjects must have received adequate first-line therapy including at a minimum: * Anti-CD20 monoclonal antibody unless investigator determines that tumor is CD20 negative, and\n     * An anthracycline containing chemotherapy regimen\n    \n    \n 4. No known history or suspicion of central nervous system involvement by lymphoma\n 5. ECOG performance status of 0 or 1\n 6. Adequate bone marrow function as evidenced by: * ANC â‰¥ 1000/uL\n     * Platelet â‰¥ 75,000/uL\n     * Absolute lymphocyte count â‰¥ 100/uL\n    \n    \n 7. Adequate renal, hepatic, cardiac, and pulmonary function as evidenced by: * Creatinine clearance (Cockcroft Gault) â‰¥ 60 mL/min\n     * Serum ALT/AST â‰¤ 2.5 ULN\n     * Total bilirubin â‰¤ 1.5 mg/dl\n     * Cardiac ejection fraction â‰¥ 50%, no evidence of pericardial effusion as determined by an ECHO, and no clinically significant ECG findings\n     * No clinically significant pleural effusion\n     * Baseline oxygen saturation > 92% on room air\n    \n    \n\nKey ","\n\n 1.  History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (eg cervix, bladder, breast) unless disease free for at least 3 years\n 2.  Received more than one line of therapy for DLBCL\n 3.  History of autologous or allogeneic stem cell transplant\n 4.  Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring intravenous antimicrobials for management.\n 5.  Known history of infection with human immunodeficiency virus (HIV) or hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive). If there is a positive history of treated hepatitis B or hepatitis C, the viral load must be undetectable per quantitative polymerase chain reaction (PCR) and/or nucleic acid testing.\n 6.  Subjects with detectable cerebrospinal fluid malignant cells or known brain metastases, or with a history of cerebrospinal fluid malignant cells or brain metastases.\n 7.  History or presence of non-malignant CNS disorder such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement\n 8.  Presence of any indwelling line or drain. Dedicated central venous access catheter such as a Port-a-Cath or Hickman catheter are permitted.\n 9.  History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, New York Heart Association Class II or greater congestive heart failure, or other clinically significant cardiac diseases within 12 months of enrollment\n 10. History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months of enrollment\n 11. History of autoimmune disease, requiring systemic immunosuppression and/or systemic disease modifying agents within the last 2 years\n 12. History of anti-CD19 or CAR-T therapy or history of prior randomization in ZUMA-7",{"$nulls":4},"Actual","2018-01-05","Actual","Anticipated","2035-01-15","Anticipated","2018-06-01","2017-12-21","2017-12-29","2018-06-13","Yes",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No","Yes",{"$nulls":3},"Yes","No",{"$nulls":19},"Event Free Survival","3 years",null,"Objective Response Rate|Overall Survival","3 years|4 years",null,"medinfo@kitepharma.com","Kite MD",-6780,"Vancouver, British Columbia, Canada|Amsterdam, Netherlands, 1105 Az|Gilbert, Arizona, United States, 85234|Stanford, California, United States, 94305|Tampa, Florida, United States, 12902|Chicago, Illinois, United States, 60637|Iowa City, Iowa, United States, 52242|Kansas City, Kansas, United States, 66160|Boston, Massachusetts, United States, 02215|Rochester, Minnesota, United States, 55905|Saint Louis, Missouri, United States, 63130|Columbus, Ohio, United States, 43210|Pittsburgh, Pennsylvania, United States, 15213|Nashville, Tennessee, United States, 37203|Houston, Texas, United States, 77030","Arizona|California|Florida|Illinois|Iowa|Kansas|Massachusetts|Minnesota|Missouri|Ohio|Pennsylvania|Tennessee|Texas","Canada|Netherlands|United States","British Columbia Vancouver General Hospital|Academic Medical Center Amsterdam|Banner Md Anderson Cancer Center|Stanford University|Moffitt Cancer Center|University Of Chicago|University Of Iowa|University Of Kansas Medical Center|Dana-Farber Cancer Institute|Mayo Clinic|Washington University|The Ohio State University|University Of Pittsburgh Medical Center|Sarah Cannon Research Institute|Md Anderson Cancer Center",{"$nulls":4},"2018-06-13","2020-05-25T16:35:19.283","2020-05-26T17:10:42.972","NCT03391466"]
["5ecbf3c7307e3d1b1f8d9c3b","NCT03391466","2018-06-19","Gilead Sciences","GILD","Recruiting","A Study Evaluating the Efficacy of Axicabtagene Ciloleucel Compared to Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma (ZUMA-7)","Axicabtagene ciloleucel|Autologous stem cell transplant","CAR-T|Autologous Cell Therapy","Yes","['Axicabtagene ciloleucel']","Yes","['CAR-T', 'Autologous Cell Therapy']","Phase 3",2,350,"Anticipated","2017-12-14","2022-01-15","EFS","Event Free Survival",{"$nulls":3},"The purpose of this study is to evaluate whether axicabtagene ciloleucel therapy improves the clinical outcome compared with standard of care second-line therapy in patients with relapsed/refractory DLBCL.","This is a phase 3 randomized, open-label, multicenter study evaluating the efficacy of axicabtagene ciloleucel versus standard of care therapy in subjects with relapsed/refractory DLBCL. Adult subjects with relapsed/refractory DLBCL after first-line rituximab and anthracycline-based chemotherapy will be randomized in a 1:1 ratio to receive axicabtagene ciloleucel or standard of care second-line therapy.\n\nStandard of care will consist of a protocol-defined, platinum-based salvage combination chemotherapy regimen followed by high-dose therapy and autologous stem cell transplant in those who respond to salvage chemotherapy.","A Phase 3, Randomized, Open-Label Study Evaluating Efficacy of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma","KTE-C19-107","Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)","Diffuse Large B-Cell Lymphoma|Lymphoma|Lymphoma, B-Cell","Oncology Hematological","Oncology","Experimental|Active Comparator","Axicabtagene Ciloleucel Treatment|Standard of Care Therapy",null,"Drug","Axicabtagene Ciloleucel|Platinum-containing salvage chemotherapy (eg, R-ICE) followed by high dose therapy (eg, BEAM) and autologous stem cell transplant in responders.","Intervention Description: N/A.","KTE-C19 | axi-cel","Axicabtagene Ciloleucel Treatment|Standard of Care Therapy","\n\n 1. Histologically proven DLBCL, including transformation from follicular lymphoma\n 2. Relapsed or refractory disease after first-line chemoimmunotherapy * Refractory disease is defined as no complete remission to first-line therapy; subjects who are intolerant to first-line therapy are excluded. * Progressive disease (PD) as best response to first-line therapy\n        * Stable disease (SD) as best response after at least 4 cycles of first-line therapy\n        * Partial response (PR) as best response after at least 6 cycles and biopsy-proven residual disease or disease progression â‰¤ 12 months from initiation of therapy\n       \n       \n     * Relapsed disease defined as complete remission to first-line therapy followed by biopsy-proven relapse â‰¤ 12 months of initiating first-line therapy\n    \n    \n 3. Subjects must have received adequate first-line therapy including at a minimum: * Anti-CD20 monoclonal antibody unless investigator determines that tumor is CD20 negative, and\n     * An anthracycline containing chemotherapy regimen\n    \n    \n 4. No known history or suspicion of central nervous system involvement by lymphoma\n 5. ECOG performance status of 0 or 1\n 6. Adequate bone marrow function as evidenced by: * ANC â‰¥ 1000/uL\n     * Platelet â‰¥ 75,000/uL\n     * Absolute lymphocyte count â‰¥ 100/uL\n    \n    \n 7. Adequate renal, hepatic, cardiac, and pulmonary function as evidenced by: * Creatinine clearance (Cockcroft Gault) â‰¥ 60 mL/min\n     * Serum ALT/AST â‰¤ 2.5 ULN\n     * Total bilirubin â‰¤ 1.5 mg/dl\n     * Cardiac ejection fraction â‰¥ 50%, no evidence of pericardial effusion as determined by an ECHO, and no clinically significant ECG findings\n     * No clinically significant pleural effusion\n     * Baseline oxygen saturation > 92% on room air\n    \n    \n\nKey ","\n\n 1.  History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (eg cervix, bladder, breast) unless disease free for at least 3 years\n 2.  Received more than one line of therapy for DLBCL\n 3.  History of autologous or allogeneic stem cell transplant\n 4.  Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring intravenous antimicrobials for management.\n 5.  Known history of infection with human immunodeficiency virus (HIV) or hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive). If there is a positive history of treated hepatitis B or hepatitis C, the viral load must be undetectable per quantitative polymerase chain reaction (PCR) and/or nucleic acid testing.\n 6.  Subjects with detectable cerebrospinal fluid malignant cells or known brain metastases, or with a history of cerebrospinal fluid malignant cells or brain metastases.\n 7.  History or presence of non-malignant CNS disorder such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement\n 8.  Presence of any indwelling line or drain. Dedicated central venous access catheter such as a Port-a-Cath or Hickman catheter are permitted.\n 9.  History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, New York Heart Association Class II or greater congestive heart failure, or other clinically significant cardiac diseases within 12 months of enrollment\n 10. History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months of enrollment\n 11. History of autoimmune disease, requiring systemic immunosuppression and/or systemic disease modifying agents within the last 2 years\n 12. History of anti-CD19 or CAR-T therapy or history of prior randomization in ZUMA-7",{"$nulls":4},"Actual","2018-01-05","Actual","Anticipated","2035-01-15","Anticipated","2018-06-01","2017-12-21","2017-12-29","2018-06-18","Yes",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No","Yes",{"$nulls":3},"Yes","No",{"$nulls":19},"Event Free Survival","3 years",null,"Objective Response Rate|Overall Survival","3 years|4 years",null,"medinfo@kitepharma.com","Kite MD",-6780,"Vancouver, British Columbia, Canada|Amsterdam, Netherlands, 1105 Az|Gilbert, Arizona, United States, 85234|Stanford, California, United States, 94305|Tampa, Florida, United States, 12902|Chicago, Illinois, United States, 60637|Iowa City, Iowa, United States, 52242|Kansas City, Kansas, United States, 66160|Boston, Massachusetts, United States, 02215|Rochester, Minnesota, United States, 55905|Saint Louis, Missouri, United States, 63130|Columbus, Ohio, United States, 43210|Pittsburgh, Pennsylvania, United States, 15213|Nashville, Tennessee, United States, 37203|Houston, Texas, United States, 77030","Arizona|California|Florida|Illinois|Iowa|Kansas|Massachusetts|Minnesota|Missouri|Ohio|Pennsylvania|Tennessee|Texas","Canada|Netherlands|United States","British Columbia Vancouver General Hospital|Academic Medical Center Amsterdam|Banner Md Anderson Cancer Center|Stanford University|Moffitt Cancer Center|University Of Chicago|University Of Iowa|University Of Kansas Medical Center|Dana-Farber Cancer Institute|Mayo Clinic|Washington University|The Ohio State University|University Of Pittsburgh Medical Center|Sarah Cannon Research Institute|Md Anderson Cancer Center",{"$nulls":4},"2018-06-18","2020-05-25T16:35:19.175","2020-05-26T17:10:42.972","NCT03391466"]
["5ecbf3c7feab101b155307dc","NCT03391466","2018-06-21","Gilead Sciences","GILD","Recruiting","A Study Evaluating the Efficacy of Axicabtagene Ciloleucel Compared to Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma (ZUMA-7)","Axicabtagene ciloleucel|Autologous stem cell transplant","CAR-T|Autologous Cell Therapy","Yes","['Axicabtagene ciloleucel']","Yes","['CAR-T', 'Autologous Cell Therapy']","Phase 3",2,350,"Anticipated","2017-12-14","2022-01-15","EFS","Event Free Survival",{"$nulls":3},"The purpose of this study is to evaluate whether axicabtagene ciloleucel therapy improves the clinical outcome compared with standard of care second-line therapy in patients with relapsed/refractory DLBCL.","This is a phase 3 randomized, open-label, multicenter study evaluating the efficacy of axicabtagene ciloleucel versus standard of care therapy in subjects with relapsed/refractory DLBCL. Adult subjects with relapsed/refractory DLBCL after first-line rituximab and anthracycline-based chemotherapy will be randomized in a 1:1 ratio to receive axicabtagene ciloleucel or standard of care second-line therapy.\n\nStandard of care will consist of a protocol-defined, platinum-based salvage combination chemotherapy regimen followed by high-dose therapy and autologous stem cell transplant in those who respond to salvage chemotherapy.","A Phase 3, Randomized, Open-Label Study Evaluating Efficacy of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma","KTE-C19-107","Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)","Diffuse Large B-Cell Lymphoma|Lymphoma|Lymphoma, B-Cell","Oncology Hematological","Oncology","Experimental|Active Comparator","Axicabtagene Ciloleucel Treatment|Standard of Care Therapy",null,"Drug","Axicabtagene Ciloleucel|Platinum-containing salvage chemotherapy (eg, R-ICE) followed by high dose therapy (eg, BEAM) and autologous stem cell transplant in responders.","Intervention Description: N/A.","KTE-C19 | axi-cel","Axicabtagene Ciloleucel Treatment|Standard of Care Therapy","\n\n 1. Histologically proven DLBCL, including transformation from follicular lymphoma\n 2. Relapsed or refractory disease after first-line chemoimmunotherapy * Refractory disease is defined as no complete remission to first-line therapy; subjects who are intolerant to first-line therapy are excluded. * Progressive disease (PD) as best response to first-line therapy\n        * Stable disease (SD) as best response after at least 4 cycles of first-line therapy\n        * Partial response (PR) as best response after at least 6 cycles and biopsy-proven residual disease or disease progression â‰¤ 12 months from initiation of therapy\n       \n       \n     * Relapsed disease defined as complete remission to first-line therapy followed by biopsy-proven relapse â‰¤ 12 months of initiating first-line therapy\n    \n    \n 3. Subjects must have received adequate first-line therapy including at a minimum: * Anti-CD20 monoclonal antibody unless investigator determines that tumor is CD20 negative, and\n     * An anthracycline containing chemotherapy regimen\n    \n    \n 4. No known history or suspicion of central nervous system involvement by lymphoma\n 5. ECOG performance status of 0 or 1\n 6. Adequate bone marrow function as evidenced by: * ANC â‰¥ 1000/uL\n     * Platelet â‰¥ 75,000/uL\n     * Absolute lymphocyte count â‰¥ 100/uL\n    \n    \n 7. Adequate renal, hepatic, cardiac, and pulmonary function as evidenced by: * Creatinine clearance (Cockcroft Gault) â‰¥ 60 mL/min\n     * Serum ALT/AST â‰¤ 2.5 ULN\n     * Total bilirubin â‰¤ 1.5 mg/dl\n     * Cardiac ejection fraction â‰¥ 50%, no evidence of pericardial effusion as determined by an ECHO, and no clinically significant ECG findings\n     * No clinically significant pleural effusion\n     * Baseline oxygen saturation > 92% on room air\n    \n    \n\nKey ","\n\n 1.  History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (eg cervix, bladder, breast) unless disease free for at least 3 years\n 2.  Received more than one line of therapy for DLBCL\n 3.  History of autologous or allogeneic stem cell transplant\n 4.  Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring intravenous antimicrobials for management.\n 5.  Known history of infection with human immunodeficiency virus (HIV) or hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive). If there is a positive history of treated hepatitis B or hepatitis C, the viral load must be undetectable per quantitative polymerase chain reaction (PCR) and/or nucleic acid testing.\n 6.  Subjects with detectable cerebrospinal fluid malignant cells or known brain metastases, or with a history of cerebrospinal fluid malignant cells or brain metastases.\n 7.  History or presence of non-malignant CNS disorder such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement\n 8.  Presence of any indwelling line or drain. Dedicated central venous access catheter such as a Port-a-Cath or Hickman catheter are permitted.\n 9.  History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, New York Heart Association Class II or greater congestive heart failure, or other clinically significant cardiac diseases within 12 months of enrollment\n 10. History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months of enrollment\n 11. History of autoimmune disease, requiring systemic immunosuppression and/or systemic disease modifying agents within the last 2 years\n 12. History of anti-CD19 or CAR-T therapy or history of prior randomization in ZUMA-7",{"$nulls":4},"Actual","2018-01-05","Actual","Anticipated","2035-01-15","Anticipated","2018-06-01","2017-12-21","2017-12-29","2018-06-19","Yes",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No","Yes",{"$nulls":3},"Yes","No",{"$nulls":19},"Event Free Survival","3 years",null,"Objective Response Rate|Overall Survival","3 years|4 years",null,"medinfo@kitepharma.com","Kite MD",-6780,"Vancouver, British Columbia, Canada|Amsterdam, Netherlands, 1105 Az|Gilbert, Arizona, United States, 85234|Stanford, California, United States, 94305|Tampa, Florida, United States, 12902|Chicago, Illinois, United States, 60637|Iowa City, Iowa, United States, 52242|Kansas City, Kansas, United States, 66160|Boston, Massachusetts, United States, 02215|Rochester, Minnesota, United States, 55905|Saint Louis, Missouri, United States, 63130|Columbus, Ohio, United States, 43210|Pittsburgh, Pennsylvania, United States, 15213|Nashville, Tennessee, United States, 37203|Houston, Texas, United States, 77030|Seattle, Washington, United States, 98104","Arizona|California|Florida|Illinois|Iowa|Kansas|Massachusetts|Minnesota|Missouri|Ohio|Pennsylvania|Tennessee|Texas|Washington","Canada|Netherlands|United States","British Columbia Vancouver General Hospital|Academic Medical Center Amsterdam|Banner Md Anderson Cancer Center|Stanford University|Moffitt Cancer Center|University Of Chicago|University Of Iowa|University Of Kansas Medical Center|Dana-Farber Cancer Institute|Mayo Clinic|Washington University|The Ohio State University|University Of Pittsburgh Medical Center|Sarah Cannon Research Institute|Md Anderson Cancer Center|Swedish Cancer Institute",{"$nulls":4},"2018-06-19","2020-05-25T16:35:19.813","2020-05-26T17:10:42.972","NCT03391466"]
["5ecbf3c7feab101b155307db","NCT03391466","2018-06-29","Gilead Sciences","GILD","Recruiting","A Study Evaluating the Efficacy of Axicabtagene Ciloleucel Compared to Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma (ZUMA-7)","Axicabtagene ciloleucel|Autologous stem cell transplant","CAR-T|Autologous Cell Therapy","Yes","['Axicabtagene ciloleucel']","Yes","['CAR-T', 'Autologous Cell Therapy']","Phase 3",2,350,"Anticipated","2017-12-14","2022-01-15","EFS","Event Free Survival",{"$nulls":3},"The purpose of this study is to evaluate whether axicabtagene ciloleucel therapy improves the clinical outcome compared with standard of care second-line therapy in patients with relapsed/refractory DLBCL.","This is a phase 3 randomized, open-label, multicenter study evaluating the efficacy of axicabtagene ciloleucel versus standard of care therapy in subjects with relapsed/refractory DLBCL. Adult subjects with relapsed/refractory DLBCL after first-line rituximab and anthracycline-based chemotherapy will be randomized in a 1:1 ratio to receive axicabtagene ciloleucel or standard of care second-line therapy.\n\nStandard of care will consist of a protocol-defined, platinum-based salvage combination chemotherapy regimen followed by high-dose therapy and autologous stem cell transplant in those who respond to salvage chemotherapy.","A Phase 3, Randomized, Open-Label Study Evaluating Efficacy of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma","KTE-C19-107","Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)","Diffuse Large B-Cell Lymphoma|Lymphoma|Lymphoma, B-Cell","Oncology Hematological","Oncology","Experimental|Active Comparator","Axicabtagene Ciloleucel Treatment|Standard of Care Therapy",null,"Drug","Axicabtagene Ciloleucel|Platinum-containing salvage chemotherapy (eg, R-ICE) followed by high dose therapy (eg, BEAM) and autologous stem cell transplant in responders.","Intervention Description: N/A.","KTE-C19 | axi-cel","Axicabtagene Ciloleucel Treatment|Standard of Care Therapy","\n\n 1. Histologically proven DLBCL, including transformation from follicular lymphoma\n 2. Relapsed or refractory disease after first-line chemoimmunotherapy * Refractory disease is defined as no complete remission to first-line therapy; subjects who are intolerant to first-line therapy are excluded. * Progressive disease (PD) as best response to first-line therapy\n        * Stable disease (SD) as best response after at least 4 cycles of first-line therapy\n        * Partial response (PR) as best response after at least 6 cycles and biopsy-proven residual disease or disease progression â‰¤ 12 months from initiation of therapy\n       \n       \n     * Relapsed disease defined as complete remission to first-line therapy followed by biopsy-proven relapse â‰¤ 12 months of initiating first-line therapy\n    \n    \n 3. Subjects must have received adequate first-line therapy including at a minimum: * Anti-CD20 monoclonal antibody unless investigator determines that tumor is CD20 negative, and\n     * An anthracycline containing chemotherapy regimen\n    \n    \n 4. No known history or suspicion of central nervous system involvement by lymphoma\n 5. ECOG performance status of 0 or 1\n 6. Adequate bone marrow function as evidenced by: * ANC â‰¥ 1000/uL\n     * Platelet â‰¥ 75,000/uL\n     * Absolute lymphocyte count â‰¥ 100/uL\n    \n    \n 7. Adequate renal, hepatic, cardiac, and pulmonary function as evidenced by: * Creatinine clearance (Cockcroft Gault) â‰¥ 60 mL/min\n     * Serum ALT/AST â‰¤ 2.5 ULN\n     * Total bilirubin â‰¤ 1.5 mg/dl\n     * Cardiac ejection fraction â‰¥ 50%, no evidence of pericardial effusion as determined by an ECHO, and no clinically significant ECG findings\n     * No clinically significant pleural effusion\n     * Baseline oxygen saturation > 92% on room air\n    \n    \n\nKey ","\n\n 1.  History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (eg cervix, bladder, breast) unless disease free for at least 3 years\n 2.  Received more than one line of therapy for DLBCL\n 3.  History of autologous or allogeneic stem cell transplant\n 4.  Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring intravenous antimicrobials for management.\n 5.  Known history of infection with human immunodeficiency virus (HIV) or hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive). If there is a positive history of treated hepatitis B or hepatitis C, the viral load must be undetectable per quantitative polymerase chain reaction (PCR) and/or nucleic acid testing.\n 6.  Subjects with detectable cerebrospinal fluid malignant cells or known brain metastases, or with a history of cerebrospinal fluid malignant cells or brain metastases.\n 7.  History or presence of non-malignant CNS disorder such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement\n 8.  Presence of any indwelling line or drain. Dedicated central venous access catheter such as a Port-a-Cath or Hickman catheter are permitted.\n 9.  History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, New York Heart Association Class II or greater congestive heart failure, or other clinically significant cardiac diseases within 12 months of enrollment\n 10. History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months of enrollment\n 11. History of autoimmune disease, requiring systemic immunosuppression and/or systemic disease modifying agents within the last 2 years\n 12. History of anti-CD19 or CAR-T therapy or history of prior randomization in ZUMA-7",{"$nulls":4},"Actual","2018-01-05","Actual","Anticipated","2035-01-15","Anticipated","2018-06-01","2017-12-21","2017-12-29","2018-06-28","Yes",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No","Yes",{"$nulls":3},"Yes","No",{"$nulls":19},"Event Free Survival","3 years",null,"Objective Response Rate|Overall Survival","3 years|4 years",null,"medinfo@kitepharma.com","Kite MD",-6780,"Leuven, Belgium|Vancouver, British Columbia, Canada|Amsterdam, Netherlands, 1105 Az|Gilbert, Arizona, United States, 85234|Stanford, California, United States, 94305|Tampa, Florida, United States, 12902|Chicago, Illinois, United States, 60637|Iowa City, Iowa, United States, 52242|Kansas City, Kansas, United States, 66160|Boston, Massachusetts, United States, 02215|Rochester, Minnesota, United States, 55905|Saint Louis, Missouri, United States, 63130|Columbus, Ohio, United States, 43210|Pittsburgh, Pennsylvania, United States, 15213|Nashville, Tennessee, United States, 37203|Houston, Texas, United States, 77030|Seattle, Washington, United States, 98104","Arizona|California|Florida|Illinois|Iowa|Kansas|Massachusetts|Minnesota|Missouri|Ohio|Pennsylvania|Tennessee|Texas|Washington","Belgium|Canada|Netherlands|United States","Uz Leuven|British Columbia Vancouver General Hospital|Academic Medical Center Amsterdam|Banner Md Anderson Cancer Center|Stanford University|Moffitt Cancer Center|University Of Chicago|University Of Iowa|University Of Kansas Medical Center|Dana-Farber Cancer Institute|Mayo Clinic|Washington University|The Ohio State University|University Of Pittsburgh Medical Center|Sarah Cannon Research Institute|Md Anderson Cancer Center|Swedish Cancer Institute",{"$nulls":4},"2018-06-28","2020-05-25T16:35:19.193","2020-05-26T17:10:42.972","NCT03391466"]
["5ecbf3c7e2561b1b11905ca7","NCT03391466","2018-07-02","Gilead Sciences","GILD","Recruiting","A Study Evaluating the Efficacy of Axicabtagene Ciloleucel Compared to Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma (ZUMA-7)","Axicabtagene ciloleucel|Autologous stem cell transplant","CAR-T|Autologous Cell Therapy","Yes","['Axicabtagene ciloleucel']","Yes","['CAR-T', 'Autologous Cell Therapy']","Phase 3",2,350,"Anticipated","2017-12-14","2022-01-15","EFS","Event Free Survival",{"$nulls":3},"The purpose of this study is to evaluate whether axicabtagene ciloleucel therapy improves the clinical outcome compared with standard of care second-line therapy in patients with relapsed/refractory DLBCL.","This is a phase 3 randomized, open-label, multicenter study evaluating the efficacy of axicabtagene ciloleucel versus standard of care therapy in subjects with relapsed/refractory DLBCL. Adult subjects with relapsed/refractory DLBCL after first-line rituximab and anthracycline-based chemotherapy will be randomized in a 1:1 ratio to receive axicabtagene ciloleucel or standard of care second-line therapy.\n\nStandard of care will consist of a protocol-defined, platinum-based salvage combination chemotherapy regimen followed by high-dose therapy and autologous stem cell transplant in those who respond to salvage chemotherapy.","A Phase 3, Randomized, Open-Label Study Evaluating Efficacy of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma","KTE-C19-107","Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)","Diffuse Large B-Cell Lymphoma|Lymphoma|Lymphoma, B-Cell","Oncology Hematological","Oncology","Experimental|Active Comparator","Axicabtagene Ciloleucel Treatment|Standard of Care Therapy",null,"Drug","Axicabtagene Ciloleucel|Platinum-containing salvage chemotherapy (eg, R-ICE) followed by high dose therapy (eg, BEAM) and autologous stem cell transplant in responders.","Intervention Description: N/A.","KTE-C19 | axi-cel","Axicabtagene Ciloleucel Treatment|Standard of Care Therapy","\n\n 1. Histologically proven DLBCL, including transformation from follicular lymphoma\n 2. Relapsed or refractory disease after first-line chemoimmunotherapy * Refractory disease is defined as no complete remission to first-line therapy; subjects who are intolerant to first-line therapy are excluded. * Progressive disease (PD) as best response to first-line therapy\n        * Stable disease (SD) as best response after at least 4 cycles of first-line therapy\n        * Partial response (PR) as best response after at least 6 cycles and biopsy-proven residual disease or disease progression â‰¤ 12 months from initiation of therapy\n       \n       \n     * Relapsed disease defined as complete remission to first-line therapy followed by biopsy-proven relapse â‰¤ 12 months of initiating first-line therapy\n    \n    \n 3. Subjects must have received adequate first-line therapy including at a minimum: * Anti-CD20 monoclonal antibody unless investigator determines that tumor is CD20 negative, and\n     * An anthracycline containing chemotherapy regimen\n    \n    \n 4. No known history or suspicion of central nervous system involvement by lymphoma\n 5. ECOG performance status of 0 or 1\n 6. Adequate bone marrow function as evidenced by: * ANC â‰¥ 1000/uL\n     * Platelet â‰¥ 75,000/uL\n     * Absolute lymphocyte count â‰¥ 100/uL\n    \n    \n 7. Adequate renal, hepatic, cardiac, and pulmonary function as evidenced by: * Creatinine clearance (Cockcroft Gault) â‰¥ 60 mL/min\n     * Serum ALT/AST â‰¤ 2.5 ULN\n     * Total bilirubin â‰¤ 1.5 mg/dl\n     * Cardiac ejection fraction â‰¥ 50%, no evidence of pericardial effusion as determined by an ECHO, and no clinically significant ECG findings\n     * No clinically significant pleural effusion\n     * Baseline oxygen saturation > 92% on room air\n    \n    \n\nKey ","\n\n 1.  History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (eg cervix, bladder, breast) unless disease free for at least 3 years\n 2.  Received more than one line of therapy for DLBCL\n 3.  History of autologous or allogeneic stem cell transplant\n 4.  Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring intravenous antimicrobials for management.\n 5.  Known history of infection with human immunodeficiency virus (HIV) or hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive). If there is a positive history of treated hepatitis B or hepatitis C, the viral load must be undetectable per quantitative polymerase chain reaction (PCR) and/or nucleic acid testing.\n 6.  Subjects with detectable cerebrospinal fluid malignant cells or known brain metastases, or with a history of cerebrospinal fluid malignant cells or brain metastases.\n 7.  History or presence of non-malignant CNS disorder such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement\n 8.  Presence of any indwelling line or drain. Dedicated central venous access catheter such as a Port-a-Cath or Hickman catheter are permitted.\n 9.  History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, New York Heart Association Class II or greater congestive heart failure, or other clinically significant cardiac diseases within 12 months of enrollment\n 10. History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months of enrollment\n 11. History of autoimmune disease, requiring systemic immunosuppression and/or systemic disease modifying agents within the last 2 years\n 12. History of anti-CD19 or CAR-T therapy or history of prior randomization in ZUMA-7",{"$nulls":4},"Actual","2018-01-05","Actual","Anticipated","2035-01-15","Anticipated","2018-06-01","2017-12-21","2017-12-29","2018-06-28","Yes",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No","Yes",{"$nulls":3},"Yes","No",{"$nulls":19},"Event Free Survival","3 years",null,"Objective Response Rate|Overall Survival","3 years|4 years",null,"medinfo@kitepharma.com","Kite MD",-6780,"Leuven, Belgium|Vancouver, British Columbia, Canada|Amsterdam, Netherlands, 1105 Az|Gilbert, Arizona, United States, 85234|Stanford, California, United States, 94305|Miami, Florida, United States, 33136|Chicago, Illinois, United States, 60637|Iowa City, Iowa, United States, 52242|Kansas City, Kansas, United States, 66160|Boston, Massachusetts, United States, 02215|Rochester, Minnesota, United States, 55905|Saint Louis, Missouri, United States, 63130|Rochester, New York, United States, 14642|Columbus, Ohio, United States, 43210|Pittsburgh, Pennsylvania, United States, 15213|Nashville, Tennessee, United States, 37203|Houston, Texas, United States, 77030|Seattle, Washington, United States, 98104","Arizona|California|Florida|Illinois|Iowa|Kansas|Massachusetts|Minnesota|Missouri|New York|Ohio|Pennsylvania|Tennessee|Texas|Washington","Belgium|Canada|Netherlands|United States","Uz Leuven|British Columbia Vancouver General Hospital|Academic Medical Center Amsterdam|Banner Md Anderson Cancer Center|Stanford University|University Of Miami|University Of Chicago|University Of Iowa|University Of Kansas Medical Center|Dana-Farber Cancer Institute|Mayo Clinic|Washington University|University Of Rochester Medical Center|The Ohio State University|University Of Pittsburgh Medical Center|Sarah Cannon Research Institute|Md Anderson Cancer Center|Swedish Cancer Institute",{"$nulls":4},"2018-06-28","2020-05-25T16:35:19.378","2020-05-26T17:10:42.972","NCT03391466"]
["5ecbf3c7307e3d1b1f8d9c3c","NCT03391466","2018-07-10","Gilead Sciences","GILD","Recruiting","A Study Evaluating the Efficacy of Axicabtagene Ciloleucel Compared to Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma (ZUMA-7)","Axicabtagene ciloleucel|Autologous stem cell transplant","CAR-T|Autologous Cell Therapy","Yes","['Axicabtagene ciloleucel']","Yes","['CAR-T', 'Autologous Cell Therapy']","Phase 3",2,350,"Anticipated","2017-12-14","2022-01-15","EFS","Event Free Survival",{"$nulls":3},"The purpose of this study is to evaluate whether axicabtagene ciloleucel therapy improves the clinical outcome compared with standard of care second-line therapy in patients with relapsed/refractory DLBCL.","This is a phase 3 randomized, open-label, multicenter study evaluating the efficacy of axicabtagene ciloleucel versus standard of care therapy in subjects with relapsed/refractory DLBCL. Adult subjects with relapsed/refractory DLBCL after first-line rituximab and anthracycline-based chemotherapy will be randomized in a 1:1 ratio to receive axicabtagene ciloleucel or standard of care second-line therapy.\n\nStandard of care will consist of a protocol-defined, platinum-based salvage combination chemotherapy regimen followed by high-dose therapy and autologous stem cell transplant in those who respond to salvage chemotherapy.","A Phase 3, Randomized, Open-Label Study Evaluating Efficacy of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma","KTE-C19-107","Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)","Diffuse Large B-Cell Lymphoma|Lymphoma|Lymphoma, B-Cell","Oncology Hematological","Oncology","Experimental|Active Comparator","Axicabtagene Ciloleucel Treatment|Standard of Care Therapy",null,"Drug","Axicabtagene Ciloleucel|Platinum-containing salvage chemotherapy (eg, R-ICE) followed by high dose therapy (eg, BEAM) and autologous stem cell transplant in responders.","Intervention Description: N/A.","KTE-C19 | axi-cel","Axicabtagene Ciloleucel Treatment|Standard of Care Therapy","\n\n 1. Histologically proven DLBCL, including transformation from follicular lymphoma\n 2. Relapsed or refractory disease after first-line chemoimmunotherapy * Refractory disease is defined as no complete remission to first-line therapy; subjects who are intolerant to first-line therapy are excluded. * Progressive disease (PD) as best response to first-line therapy\n        * Stable disease (SD) as best response after at least 4 cycles of first-line therapy\n        * Partial response (PR) as best response after at least 6 cycles and biopsy-proven residual disease or disease progression â‰¤ 12 months from initiation of therapy\n       \n       \n     * Relapsed disease defined as complete remission to first-line therapy followed by biopsy-proven relapse â‰¤ 12 months of initiating first-line therapy\n    \n    \n 3. Subjects must have received adequate first-line therapy including at a minimum: * Anti-CD20 monoclonal antibody unless investigator determines that tumor is CD20 negative, and\n     * An anthracycline containing chemotherapy regimen\n    \n    \n 4. No known history or suspicion of central nervous system involvement by lymphoma\n 5. ECOG performance status of 0 or 1\n 6. Adequate bone marrow function as evidenced by: * ANC â‰¥ 1000/uL\n     * Platelet â‰¥ 75,000/uL\n     * Absolute lymphocyte count â‰¥ 100/uL\n    \n    \n 7. Adequate renal, hepatic, cardiac, and pulmonary function as evidenced by: * Creatinine clearance (Cockcroft Gault) â‰¥ 60 mL/min\n     * Serum ALT/AST â‰¤ 2.5 ULN\n     * Total bilirubin â‰¤ 1.5 mg/dl\n     * Cardiac ejection fraction â‰¥ 50%, no evidence of pericardial effusion as determined by an ECHO, and no clinically significant ECG findings\n     * No clinically significant pleural effusion\n     * Baseline oxygen saturation > 92% on room air\n    \n    \n\nKey ","\n\n 1.  History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (eg cervix, bladder, breast) unless disease free for at least 3 years\n 2.  Received more than one line of therapy for DLBCL\n 3.  History of autologous or allogeneic stem cell transplant\n 4.  Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring intravenous antimicrobials for management.\n 5.  Known history of infection with human immunodeficiency virus (HIV) or hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive). If there is a positive history of treated hepatitis B or hepatitis C, the viral load must be undetectable per quantitative polymerase chain reaction (PCR) and/or nucleic acid testing.\n 6.  Subjects with detectable cerebrospinal fluid malignant cells or known brain metastases, or with a history of cerebrospinal fluid malignant cells or brain metastases.\n 7.  History or presence of non-malignant CNS disorder such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement\n 8.  Presence of any indwelling line or drain. Dedicated central venous access catheter such as a Port-a-Cath or Hickman catheter are permitted.\n 9.  History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, New York Heart Association Class II or greater congestive heart failure, or other clinically significant cardiac diseases within 12 months of enrollment\n 10. History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months of enrollment\n 11. History of autoimmune disease, requiring systemic immunosuppression and/or systemic disease modifying agents within the last 2 years\n 12. History of anti-CD19 or CAR-T therapy or history of prior randomization in ZUMA-7",{"$nulls":4},"Actual","2018-01-05","Actual","Anticipated","2035-01-15","Anticipated","2018-07-01","2017-12-21","2017-12-29","2018-07-09","Yes",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No","Yes",{"$nulls":3},"Yes","No",{"$nulls":19},"Event Free Survival","3 years",null,"Objective Response Rate|Overall Survival","3 years|4 years",null,"medinfo@kitepharma.com","Kite MD",-6780,"Leuven, Belgium|Vancouver, British Columbia, Canada|Toronto, Ontario, Canada, M5G 2M9|Amsterdam, Netherlands, 1105 Az|Gilbert, Arizona, United States, 85234|Stanford, California, United States, 94305|Miami, Florida, United States, 33136|Chicago, Illinois, United States, 60637|Iowa City, Iowa, United States, 52242|Kansas City, Kansas, United States, 66160|Boston, Massachusetts, United States, 02215|Rochester, Minnesota, United States, 55905|Saint Louis, Missouri, United States, 63130|Rochester, New York, United States, 14642|Columbus, Ohio, United States, 43210|Pittsburgh, Pennsylvania, United States, 15213|Nashville, Tennessee, United States, 37203|Houston, Texas, United States, 77030|Seattle, Washington, United States, 98104","Arizona|California|Florida|Illinois|Iowa|Kansas|Massachusetts|Minnesota|Missouri|New York|Ohio|Pennsylvania|Tennessee|Texas|Washington","Belgium|Canada|Netherlands|United States","Uz Leuven|British Columbia Vancouver General Hospital|Ontario Princess Margaret Hospital|Academic Medical Center Amsterdam|Banner Md Anderson Cancer Center|Stanford University|University Of Miami|University Of Chicago|University Of Iowa|University Of Kansas Medical Center|Dana-Farber Cancer Institute|Mayo Clinic|Washington University|University Of Rochester Medical Center|The Ohio State University|University Of Pittsburgh Medical Center|Sarah Cannon Research Institute|Md Anderson Cancer Center|Swedish Cancer Institute",{"$nulls":4},"2018-07-09","2020-05-25T16:35:19.714","2020-05-26T17:10:42.972","NCT03391466"]
["5ecbf3c7fe30261b1a0481ac","NCT03391466","2018-07-11","Gilead Sciences","GILD","Recruiting","A Study Evaluating the Efficacy of Axicabtagene Ciloleucel Compared to Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma (ZUMA-7)","Axicabtagene ciloleucel|Autologous stem cell transplant","CAR-T|Autologous Cell Therapy","Yes","['Axicabtagene ciloleucel']","Yes","['CAR-T', 'Autologous Cell Therapy']","Phase 3",2,350,"Anticipated","2017-12-14","2022-01-15","EFS","Event Free Survival",{"$nulls":3},"The purpose of this study is to evaluate whether axicabtagene ciloleucel therapy improves the clinical outcome compared with standard of care second-line therapy in patients with relapsed/refractory DLBCL.","This is a phase 3 randomized, open-label, multicenter study evaluating the efficacy of axicabtagene ciloleucel versus standard of care therapy in subjects with relapsed/refractory DLBCL. Adult subjects with relapsed/refractory DLBCL after first-line rituximab and anthracycline-based chemotherapy will be randomized in a 1:1 ratio to receive axicabtagene ciloleucel or standard of care second-line therapy.\n\nStandard of care will consist of a protocol-defined, platinum-based salvage combination chemotherapy regimen followed by high-dose therapy and autologous stem cell transplant in those who respond to salvage chemotherapy.","A Phase 3, Randomized, Open-Label Study Evaluating Efficacy of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma","KTE-C19-107","Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)","Diffuse Large B-Cell Lymphoma|Lymphoma|Lymphoma, B-Cell","Oncology Hematological","Oncology","Experimental|Active Comparator","Axicabtagene Ciloleucel Treatment|Standard of Care Therapy",null,"Drug","Axicabtagene Ciloleucel|Platinum-containing salvage chemotherapy (eg, R-ICE) followed by high dose therapy (eg, BEAM) and autologous stem cell transplant in responders.","Intervention Description: N/A.","KTE-C19 | axi-cel","Axicabtagene Ciloleucel Treatment|Standard of Care Therapy","\n\n 1. Histologically proven DLBCL, including transformation from follicular lymphoma\n 2. Relapsed or refractory disease after first-line chemoimmunotherapy * Refractory disease is defined as no complete remission to first-line therapy; subjects who are intolerant to first-line therapy are excluded. * Progressive disease (PD) as best response to first-line therapy\n        * Stable disease (SD) as best response after at least 4 cycles of first-line therapy\n        * Partial response (PR) as best response after at least 6 cycles and biopsy-proven residual disease or disease progression â‰¤ 12 months from initiation of therapy\n       \n       \n     * Relapsed disease defined as complete remission to first-line therapy followed by biopsy-proven relapse â‰¤ 12 months of initiating first-line therapy\n    \n    \n 3. Subjects must have received adequate first-line therapy including at a minimum: * Anti-CD20 monoclonal antibody unless investigator determines that tumor is CD20 negative, and\n     * An anthracycline containing chemotherapy regimen\n    \n    \n 4. No known history or suspicion of central nervous system involvement by lymphoma\n 5. ECOG performance status of 0 or 1\n 6. Adequate bone marrow function as evidenced by: * ANC â‰¥ 1000/uL\n     * Platelet â‰¥ 75,000/uL\n     * Absolute lymphocyte count â‰¥ 100/uL\n    \n    \n 7. Adequate renal, hepatic, cardiac, and pulmonary function as evidenced by: * Creatinine clearance (Cockcroft Gault) â‰¥ 60 mL/min\n     * Serum ALT/AST â‰¤ 2.5 ULN\n     * Total bilirubin â‰¤ 1.5 mg/dl\n     * Cardiac ejection fraction â‰¥ 50%, no evidence of pericardial effusion as determined by an ECHO, and no clinically significant ECG findings\n     * No clinically significant pleural effusion\n     * Baseline oxygen saturation > 92% on room air\n    \n    \n\nKey ","\n\n 1.  History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (eg cervix, bladder, breast) unless disease free for at least 3 years\n 2.  Received more than one line of therapy for DLBCL\n 3.  History of autologous or allogeneic stem cell transplant\n 4.  Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring intravenous antimicrobials for management.\n 5.  Known history of infection with human immunodeficiency virus (HIV) or hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive). If there is a positive history of treated hepatitis B or hepatitis C, the viral load must be undetectable per quantitative polymerase chain reaction (PCR) and/or nucleic acid testing.\n 6.  Subjects with detectable cerebrospinal fluid malignant cells or known brain metastases, or with a history of cerebrospinal fluid malignant cells or brain metastases.\n 7.  History or presence of non-malignant CNS disorder such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement\n 8.  Presence of any indwelling line or drain. Dedicated central venous access catheter such as a Port-a-Cath or Hickman catheter are permitted.\n 9.  History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, New York Heart Association Class II or greater congestive heart failure, or other clinically significant cardiac diseases within 12 months of enrollment\n 10. History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months of enrollment\n 11. History of autoimmune disease, requiring systemic immunosuppression and/or systemic disease modifying agents within the last 2 years\n 12. History of anti-CD19 or CAR-T therapy or history of prior randomization in ZUMA-7",{"$nulls":4},"Actual","2018-01-05","Actual","Anticipated","2035-01-15","Anticipated","2018-07-01","2017-12-21","2017-12-29","2018-07-09","Yes",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No","Yes",{"$nulls":3},"Yes","No",{"$nulls":19},"Event Free Survival","3 years",null,"Objective Response Rate|Overall Survival","3 years|4 years",null,"medinfo@kitepharma.com","Kite MD",-6780,"Leuven, Belgium|Vancouver, British Columbia, Canada|Toronto, Ontario, Canada, M5G 2M9|Amsterdam, Netherlands, 1105 Az|Gilbert, Arizona, United States, 85234|Stanford, California, United States, 94305|Miami, Florida, United States, 33136|Chicago, Illinois, United States, 60637|Iowa City, Iowa, United States, 52242|Kansas City, Kansas, United States, 66160|Baltimore, Maryland, United States, 21201|Boston, Massachusetts, United States, 02215|Rochester, Minnesota, United States, 55905|Saint Louis, Missouri, United States, 63130|New York, New York, United States, 10065|Columbus, Ohio, United States, 43210|Pittsburgh, Pennsylvania, United States, 15213|Nashville, Tennessee, United States, 37203|Houston, Texas, United States, 77030|Seattle, Washington, United States, 98104","Arizona|California|Florida|Illinois|Iowa|Kansas|Maryland|Massachusetts|Minnesota|Missouri|New York|Ohio|Pennsylvania|Tennessee|Texas|Washington","Belgium|Canada|Netherlands|United States","Uz Leuven|British Columbia Vancouver General Hospital|Ontario Princess Margaret Hospital|Academic Medical Center Amsterdam|Banner Md Anderson Cancer Center|Stanford University|University Of Miami|University Of Chicago|University Of Iowa|University Of Kansas Medical Center|University Of Maryland|Dana-Farber Cancer Institute|Mayo Clinic|Washington University|Memorial Sloan Kettering|The Ohio State University|University Of Pittsburgh Medical Center|Sarah Cannon Research Institute|Md Anderson Cancer Center|Swedish Cancer Institute",{"$nulls":4},"2018-07-09","2020-05-25T16:35:19.403","2020-05-26T17:10:42.972","NCT03391466"]
["5ecbf3c711702c1b1b9169c0","NCT03391466","2018-07-20","Gilead Sciences","GILD","Recruiting","A Study Evaluating the Efficacy of Axicabtagene Ciloleucel Compared to Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma (ZUMA-7)","Axicabtagene ciloleucel|Autologous stem cell transplant","CAR-T|Autologous Cell Therapy","Yes","['Axicabtagene ciloleucel']","Yes","['CAR-T', 'Autologous Cell Therapy']","Phase 3",2,350,"Anticipated","2017-12-14","2022-01-15","EFS","Event Free Survival",{"$nulls":3},"The purpose of this study is to evaluate whether axicabtagene ciloleucel therapy improves the clinical outcome compared with standard of care second-line therapy in patients with relapsed/refractory DLBCL.","This is a phase 3 randomized, open-label, multicenter study evaluating the efficacy of axicabtagene ciloleucel versus standard of care therapy in subjects with relapsed/refractory DLBCL. Adult subjects with relapsed/refractory DLBCL after first-line rituximab and anthracycline-based chemotherapy will be randomized in a 1:1 ratio to receive axicabtagene ciloleucel or standard of care second-line therapy.\n\nStandard of care will consist of a protocol-defined, platinum-based salvage combination chemotherapy regimen followed by high-dose therapy and autologous stem cell transplant in those who respond to salvage chemotherapy.","A Phase 3, Randomized, Open-Label Study Evaluating Efficacy of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma","KTE-C19-107","Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)","Diffuse Large B-Cell Lymphoma|Lymphoma|Lymphoma, B-Cell","Oncology Hematological","Oncology","Experimental|Active Comparator","Axicabtagene Ciloleucel Treatment|Standard of Care Therapy",null,"Drug","Axicabtagene Ciloleucel|Platinum-containing salvage chemotherapy (eg, R-ICE) followed by high dose therapy (eg, BEAM) and autologous stem cell transplant in responders.","Intervention Description: N/A.","KTE-C19 | axi-cel","Axicabtagene Ciloleucel Treatment|Standard of Care Therapy","\n\n 1. Histologically proven DLBCL, including transformation from follicular lymphoma\n 2. Relapsed or refractory disease after first-line chemoimmunotherapy * Refractory disease is defined as no complete remission to first-line therapy; subjects who are intolerant to first-line therapy are excluded. * Progressive disease (PD) as best response to first-line therapy\n        * Stable disease (SD) as best response after at least 4 cycles of first-line therapy\n        * Partial response (PR) as best response after at least 6 cycles and biopsy-proven residual disease or disease progression â‰¤ 12 months from initiation of therapy\n       \n       \n     * Relapsed disease defined as complete remission to first-line therapy followed by biopsy-proven relapse â‰¤ 12 months of initiating first-line therapy\n    \n    \n 3. Subjects must have received adequate first-line therapy including at a minimum: * Anti-CD20 monoclonal antibody unless investigator determines that tumor is CD20 negative, and\n     * An anthracycline containing chemotherapy regimen\n    \n    \n 4. No known history or suspicion of central nervous system involvement by lymphoma\n 5. ECOG performance status of 0 or 1\n 6. Adequate bone marrow function as evidenced by: * ANC â‰¥ 1000/uL\n     * Platelet â‰¥ 75,000/uL\n     * Absolute lymphocyte count â‰¥ 100/uL\n    \n    \n 7. Adequate renal, hepatic, cardiac, and pulmonary function as evidenced by: * Creatinine clearance (Cockcroft Gault) â‰¥ 60 mL/min\n     * Serum ALT/AST â‰¤ 2.5 ULN\n     * Total bilirubin â‰¤ 1.5 mg/dl\n     * Cardiac ejection fraction â‰¥ 50%, no evidence of pericardial effusion as determined by an ECHO, and no clinically significant ECG findings\n     * No clinically significant pleural effusion\n     * Baseline oxygen saturation > 92% on room air\n    \n    \n\nKey ","\n\n 1.  History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (eg cervix, bladder, breast) unless disease free for at least 3 years\n 2.  Received more than one line of therapy for DLBCL\n 3.  History of autologous or allogeneic stem cell transplant\n 4.  Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring intravenous antimicrobials for management.\n 5.  Known history of infection with human immunodeficiency virus (HIV) or hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive). If there is a positive history of treated hepatitis B or hepatitis C, the viral load must be undetectable per quantitative polymerase chain reaction (PCR) and/or nucleic acid testing.\n 6.  Subjects with detectable cerebrospinal fluid malignant cells or known brain metastases, or with a history of cerebrospinal fluid malignant cells or brain metastases.\n 7.  History or presence of non-malignant CNS disorder such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement\n 8.  Presence of any indwelling line or drain. Dedicated central venous access catheter such as a Port-a-Cath or Hickman catheter are permitted.\n 9.  History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, New York Heart Association Class II or greater congestive heart failure, or other clinically significant cardiac diseases within 12 months of enrollment\n 10. History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months of enrollment\n 11. History of autoimmune disease, requiring systemic immunosuppression and/or systemic disease modifying agents within the last 2 years\n 12. History of anti-CD19 or CAR-T therapy or history of prior randomization in ZUMA-7",{"$nulls":4},"Actual","2018-01-05","Actual","Anticipated","2035-01-15","Anticipated","2018-07-01","2017-12-21","2017-12-29","2018-07-18","Yes",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No","Yes",{"$nulls":3},"Yes","No",{"$nulls":19},"Event Free Survival",44197,null,"Objective Response Rate|Overall Survival","Jan 2021|Jan 2022",null,"medinfo@kitepharma.com","Kite MD",-6780,"Brussels, Belgium|Vancouver, British Columbia, Canada|Toronto, Ontario, Canada, M5G 2M9|Amsterdam, Netherlands, 1105 Az|Gilbert, Arizona, United States, 85234|Stanford, California, United States, 94305|Miami, Florida, United States, 33136|Chicago, Illinois, United States, 60637|Iowa City, Iowa, United States, 52242|Kansas City, Kansas, United States, 66160|Baltimore, Maryland, United States, 21201|Boston, Massachusetts, United States, 02215|Rochester, Minnesota, United States, 55905|Saint Louis, Missouri, United States, 63130|New York, New York, United States, 10065|Columbus, Ohio, United States, 43210|Pittsburgh, Pennsylvania, United States, 15213|Nashville, Tennessee, United States, 37203|Houston, Texas, United States, 77030|Seattle, Washington, United States, 98104","Arizona|California|Florida|Illinois|Iowa|Kansas|Maryland|Massachusetts|Minnesota|Missouri|New York|Ohio|Pennsylvania|Tennessee|Texas|Washington","Belgium|Canada|Netherlands|United States","Cliniques Universiaires Saint-Luc|British Columbia Vancouver General Hospital|Ontario Princess Margaret Hospital|Academic Medical Center Amsterdam|Banner Md Anderson Cancer Center|Stanford University|University Of Miami|University Of Chicago|University Of Iowa|University Of Kansas Medical Center|University Of Maryland|Dana-Farber Cancer Institute|Mayo Clinic|Washington University|Memorial Sloan Kettering|The Ohio State University|University Of Pittsburgh Medical Center|Sarah Cannon Research Institute|Md Anderson Cancer Center|Swedish Cancer Institute",{"$nulls":4},"2018-07-18","2020-05-25T16:35:19.935","2020-05-26T17:10:42.972","NCT03391466"]
["5ecbf3c8307e3d1b1f8d9c3d","NCT03391466","2018-07-24","Gilead Sciences","GILD","Recruiting","A Study Evaluating the Efficacy of Axicabtagene Ciloleucel Compared to Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma (ZUMA-7)","Axicabtagene ciloleucel|Autologous stem cell transplant","CAR-T|Autologous Cell Therapy","Yes","['Axicabtagene ciloleucel']","Yes","['CAR-T', 'Autologous Cell Therapy']","Phase 3",2,350,"Anticipated","2017-12-14","2022-01-15","EFS","Event Free Survival",{"$nulls":3},"The purpose of this study is to evaluate whether axicabtagene ciloleucel therapy improves the clinical outcome compared with standard of care second-line therapy in patients with relapsed/refractory DLBCL.","This is a phase 3 randomized, open-label, multicenter study evaluating the efficacy of axicabtagene ciloleucel versus standard of care therapy in subjects with relapsed/refractory DLBCL. Adult subjects with relapsed/refractory DLBCL after first-line rituximab and anthracycline-based chemotherapy will be randomized in a 1:1 ratio to receive axicabtagene ciloleucel or standard of care second-line therapy.\n\nStandard of care will consist of a protocol-defined, platinum-based salvage combination chemotherapy regimen followed by high-dose therapy and autologous stem cell transplant in those who respond to salvage chemotherapy.","A Phase 3, Randomized, Open-Label Study Evaluating Efficacy of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma","KTE-C19-107","Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)","Diffuse Large B-Cell Lymphoma|Lymphoma|Lymphoma, B-Cell","Oncology Hematological","Oncology","Experimental|Active Comparator","Axicabtagene Ciloleucel Treatment|Standard of Care Therapy",null,"Drug","Axicabtagene Ciloleucel|Platinum-containing salvage chemotherapy (eg, R-ICE) followed by high dose therapy (eg, BEAM) and autologous stem cell transplant in responders.","Intervention Description: N/A.","KTE-C19 | axi-cel","Axicabtagene Ciloleucel Treatment|Standard of Care Therapy","\n\n 1. Histologically proven DLBCL, including transformation from follicular lymphoma\n 2. Relapsed or refractory disease after first-line chemoimmunotherapy * Refractory disease is defined as no complete remission to first-line therapy; subjects who are intolerant to first-line therapy are excluded. * Progressive disease (PD) as best response to first-line therapy\n        * Stable disease (SD) as best response after at least 4 cycles of first-line therapy\n        * Partial response (PR) as best response after at least 6 cycles and biopsy-proven residual disease or disease progression â‰¤ 12 months from initiation of therapy\n       \n       \n     * Relapsed disease defined as complete remission to first-line therapy followed by biopsy-proven relapse â‰¤ 12 months of initiating first-line therapy\n    \n    \n 3. Subjects must have received adequate first-line therapy including at a minimum: * Anti-CD20 monoclonal antibody unless investigator determines that tumor is CD20 negative, and\n     * An anthracycline containing chemotherapy regimen\n    \n    \n 4. No known history or suspicion of central nervous system involvement by lymphoma\n 5. ECOG performance status of 0 or 1\n 6. Adequate bone marrow function as evidenced by: * ANC â‰¥ 1000/uL\n     * Platelet â‰¥ 75,000/uL\n     * Absolute lymphocyte count â‰¥ 100/uL\n    \n    \n 7. Adequate renal, hepatic, cardiac, and pulmonary function as evidenced by: * Creatinine clearance (Cockcroft Gault) â‰¥ 60 mL/min\n     * Serum ALT/AST â‰¤ 2.5 ULN\n     * Total bilirubin â‰¤ 1.5 mg/dl\n     * Cardiac ejection fraction â‰¥ 50%, no evidence of pericardial effusion as determined by an ECHO, and no clinically significant ECG findings\n     * No clinically significant pleural effusion\n     * Baseline oxygen saturation > 92% on room air\n    \n    \n\nKey ","\n\n 1.  History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (eg cervix, bladder, breast) unless disease free for at least 3 years\n 2.  Received more than one line of therapy for DLBCL\n 3.  History of autologous or allogeneic stem cell transplant\n 4.  Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring intravenous antimicrobials for management.\n 5.  Known history of infection with human immunodeficiency virus (HIV) or hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive). If there is a positive history of treated hepatitis B or hepatitis C, the viral load must be undetectable per quantitative polymerase chain reaction (PCR) and/or nucleic acid testing.\n 6.  Subjects with detectable cerebrospinal fluid malignant cells or known brain metastases, or with a history of cerebrospinal fluid malignant cells or brain metastases.\n 7.  History or presence of non-malignant CNS disorder such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement\n 8.  Presence of any indwelling line or drain. Dedicated central venous access catheter such as a Port-a-Cath or Hickman catheter are permitted.\n 9.  History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, New York Heart Association Class II or greater congestive heart failure, or other clinically significant cardiac diseases within 12 months of enrollment\n 10. History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months of enrollment\n 11. History of autoimmune disease, requiring systemic immunosuppression and/or systemic disease modifying agents within the last 2 years\n 12. History of anti-CD19 or CAR-T therapy or history of prior randomization in ZUMA-7",{"$nulls":4},"Actual","2018-01-05","Actual","Anticipated","2035-01-15","Anticipated","2018-07-01","2017-12-21","2017-12-29","2018-07-23","Yes",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No","Yes",{"$nulls":3},"Yes","No",{"$nulls":19},"Event Free Survival",44197,null,"Objective Response Rate|Overall Survival","Jan 2021|Jan 2022",null,"medinfo@kitepharma.com","Kite MD",-6780,"Brussels, Belgium|Vancouver, British Columbia, Canada|Toronto, Ontario, Canada, M5G 2M9|Amsterdam, Netherlands, 1105 Az|Gilbert, Arizona, United States, 85234|Stanford, California, United States, 94305|Miami, Florida, United States, 33136|Chicago, Illinois, United States, 60637|Iowa City, Iowa, United States, 52242|Kansas City, Kansas, United States, 66160|Baltimore, Maryland, United States, 21201|Boston, Massachusetts, United States, 02215|Rochester, Minnesota, United States, 55905|Saint Louis, Missouri, United States, 63130|Hackensack, New Jersey, United States, 07601|New York, New York, United States, 10065|Columbus, Ohio, United States, 43210|Pittsburgh, Pennsylvania, United States, 15213|Nashville, Tennessee, United States, 37203|Houston, Texas, United States, 77030|Seattle, Washington, United States, 98104","Arizona|California|Florida|Illinois|Iowa|Kansas|Maryland|Massachusetts|Minnesota|Missouri|New Jersey|New York|Ohio|Pennsylvania|Tennessee|Texas|Washington","Belgium|Canada|Netherlands|United States","Cliniques Universiaires Saint-Luc|British Columbia Vancouver General Hospital|Ontario Princess Margaret Hospital|Academic Medical Center Amsterdam|Banner Md Anderson Cancer Center|Stanford University|University Of Miami|University Of Chicago|University Of Iowa|University Of Kansas Medical Center|University Of Maryland|Dana-Farber Cancer Institute|Mayo Clinic|Washington University|Hackensack University Medical Center|Memorial Sloan Kettering|The Ohio State University|University Of Pittsburgh Medical Center|Sarah Cannon Research Institute|Md Anderson Cancer Center|Swedish Cancer Institute",{"$nulls":4},"2018-07-23","2020-05-25T16:35:20.041","2020-05-26T17:10:42.972","NCT03391466"]
["5ecbf3c8fe30261b1a0481ad","NCT03391466","2018-07-26","Gilead Sciences","GILD","Recruiting","A Study Evaluating the Efficacy of Axicabtagene Ciloleucel Compared to Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma (ZUMA-7)","Axicabtagene ciloleucel|Autologous stem cell transplant","CAR-T|Autologous Cell Therapy","Yes","['Axicabtagene ciloleucel']","Yes","['CAR-T', 'Autologous Cell Therapy']","Phase 3",2,350,"Anticipated","2017-12-14","2022-01-15","EFS","Event Free Survival",{"$nulls":3},"The purpose of this study is to evaluate whether axicabtagene ciloleucel therapy improves the clinical outcome compared with standard of care second-line therapy in patients with relapsed/refractory DLBCL.","This is a phase 3 randomized, open-label, multicenter study evaluating the efficacy of axicabtagene ciloleucel versus standard of care therapy in subjects with relapsed/refractory DLBCL. Adult subjects with relapsed/refractory DLBCL after first-line rituximab and anthracycline-based chemotherapy will be randomized in a 1:1 ratio to receive axicabtagene ciloleucel or standard of care second-line therapy.\n\nStandard of care will consist of a protocol-defined, platinum-based salvage combination chemotherapy regimen followed by high-dose therapy and autologous stem cell transplant in those who respond to salvage chemotherapy.","A Phase 3, Randomized, Open-Label Study Evaluating Efficacy of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma","KTE-C19-107","Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)","Diffuse Large B-Cell Lymphoma|Lymphoma|Lymphoma, B-Cell","Oncology Hematological","Oncology","Experimental|Active Comparator","Axicabtagene Ciloleucel Treatment|Standard of Care Therapy",null,"Drug","Axicabtagene Ciloleucel|Platinum-containing salvage chemotherapy (eg, R-ICE) followed by high dose therapy (eg, BEAM) and autologous stem cell transplant in responders.","Intervention Description: N/A.","KTE-C19 | axi-cel","Axicabtagene Ciloleucel Treatment|Standard of Care Therapy","\n\n 1. Histologically proven DLBCL, including transformation from follicular lymphoma\n 2. Relapsed or refractory disease after first-line chemoimmunotherapy * Refractory disease is defined as no complete remission to first-line therapy; subjects who are intolerant to first-line therapy are excluded. * Progressive disease (PD) as best response to first-line therapy\n        * Stable disease (SD) as best response after at least 4 cycles of first-line therapy\n        * Partial response (PR) as best response after at least 6 cycles and biopsy-proven residual disease or disease progression â‰¤ 12 months from initiation of therapy\n       \n       \n     * Relapsed disease defined as complete remission to first-line therapy followed by biopsy-proven relapse â‰¤ 12 months of initiating first-line therapy\n    \n    \n 3. Subjects must have received adequate first-line therapy including at a minimum: * Anti-CD20 monoclonal antibody unless investigator determines that tumor is CD20 negative, and\n     * An anthracycline containing chemotherapy regimen\n    \n    \n 4. No known history or suspicion of central nervous system involvement by lymphoma\n 5. ECOG performance status of 0 or 1\n 6. Adequate bone marrow function as evidenced by: * ANC â‰¥ 1000/uL\n     * Platelet â‰¥ 75,000/uL\n     * Absolute lymphocyte count â‰¥ 100/uL\n    \n    \n 7. Adequate renal, hepatic, cardiac, and pulmonary function as evidenced by: * Creatinine clearance (Cockcroft Gault) â‰¥ 60 mL/min\n     * Serum ALT/AST â‰¤ 2.5 ULN\n     * Total bilirubin â‰¤ 1.5 mg/dl\n     * Cardiac ejection fraction â‰¥ 50%, no evidence of pericardial effusion as determined by an ECHO, and no clinically significant ECG findings\n     * No clinically significant pleural effusion\n     * Baseline oxygen saturation > 92% on room air\n    \n    \n\nKey ","\n\n 1.  History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (eg cervix, bladder, breast) unless disease free for at least 3 years\n 2.  Received more than one line of therapy for DLBCL\n 3.  History of autologous or allogeneic stem cell transplant\n 4.  Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring intravenous antimicrobials for management.\n 5.  Known history of infection with human immunodeficiency virus (HIV) or hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive). If there is a positive history of treated hepatitis B or hepatitis C, the viral load must be undetectable per quantitative polymerase chain reaction (PCR) and/or nucleic acid testing.\n 6.  Subjects with detectable cerebrospinal fluid malignant cells or known brain metastases, or with a history of cerebrospinal fluid malignant cells or brain metastases.\n 7.  History or presence of non-malignant CNS disorder such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement\n 8.  Presence of any indwelling line or drain. Dedicated central venous access catheter such as a Port-a-Cath or Hickman catheter are permitted.\n 9.  History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, New York Heart Association Class II or greater congestive heart failure, or other clinically significant cardiac diseases within 12 months of enrollment\n 10. History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months of enrollment\n 11. History of autoimmune disease, requiring systemic immunosuppression and/or systemic disease modifying agents within the last 2 years\n 12. History of anti-CD19 or CAR-T therapy or history of prior randomization in ZUMA-7",{"$nulls":4},"Actual","2018-01-05","Actual","Anticipated","2035-01-15","Anticipated","2018-07-01","2017-12-21","2017-12-29","2018-07-24","Yes",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No","Yes",{"$nulls":3},"Yes","No",{"$nulls":19},"Event Free Survival",44197,null,"Objective Response Rate|Overall Survival","Jan 2021|Jan 2022",null,"medinfo@kitepharma.com","Kite MD",-6780,"Brussels, Belgium|Vancouver, British Columbia, Canada|Toronto, Ontario, Canada, M5G 2M9|Amsterdam, Netherlands, 1105 Az|Gilbert, Arizona, United States, 85234|San Diego, California, United States, 92093-0698|Miami, Florida, United States, 33136|Chicago, Illinois, United States, 60637|Iowa City, Iowa, United States, 52242|Kansas City, Kansas, United States, 66160|Baltimore, Maryland, United States, 21201|Boston, Massachusetts, United States, 02215|Rochester, Minnesota, United States, 55905|Saint Louis, Missouri, United States, 63130|Hackensack, New Jersey, United States, 07601|New York, New York, United States, 10065|Columbus, Ohio, United States, 43210|Pittsburgh, Pennsylvania, United States, 15213|Nashville, Tennessee, United States, 37203|Houston, Texas, United States, 77030|Seattle, Washington, United States, 98104","Arizona|California|Florida|Illinois|Iowa|Kansas|Maryland|Massachusetts|Minnesota|Missouri|New Jersey|New York|Ohio|Pennsylvania|Tennessee|Texas|Washington","Belgium|Canada|Netherlands|United States","Cliniques Universiaires Saint-Luc|British Columbia Vancouver General Hospital|Ontario Princess Margaret Hospital|Academic Medical Center Amsterdam|Banner Md Anderson Cancer Center|Uc San Diego Moores Cancer Center|University Of Miami|University Of Chicago|University Of Iowa|University Of Kansas Medical Center|University Of Maryland|Dana-Farber Cancer Institute|Mayo Clinic|Washington University|Hackensack University Medical Center|Memorial Sloan Kettering|The Ohio State University|University Of Pittsburgh Medical Center|Sarah Cannon Research Institute|Md Anderson Cancer Center|Swedish Cancer Institute",{"$nulls":4},"2018-07-24","2020-05-25T16:35:20.056","2020-05-26T17:10:42.972","NCT03391466"]
["5ecbf3c7e2561b1b11905ca8","NCT03391466","2018-08-01","Gilead Sciences","GILD","Recruiting","A Study Evaluating the Efficacy of Axicabtagene Ciloleucel Compared to Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma (ZUMA-7)","Axicabtagene ciloleucel|Autologous stem cell transplant","CAR-T|Autologous Cell Therapy","Yes","['Axicabtagene ciloleucel']","Yes","['CAR-T', 'Autologous Cell Therapy']","Phase 3",2,350,"Anticipated","2017-12-14","2022-01-15","EFS","Event Free Survival",{"$nulls":3},"The purpose of this study is to evaluate whether axicabtagene ciloleucel therapy improves the clinical outcome compared with standard of care second-line therapy in patients with relapsed/refractory DLBCL.","This is a phase 3 randomized, open-label, multicenter study evaluating the efficacy of axicabtagene ciloleucel versus standard of care therapy in subjects with relapsed/refractory DLBCL. Adult subjects with relapsed/refractory DLBCL after first-line rituximab and anthracycline-based chemotherapy will be randomized in a 1:1 ratio to receive axicabtagene ciloleucel or standard of care second-line therapy.\n\nStandard of care will consist of a protocol-defined, platinum-based salvage combination chemotherapy regimen followed by high-dose therapy and autologous stem cell transplant in those who respond to salvage chemotherapy.","A Phase 3, Randomized, Open-Label Study Evaluating Efficacy of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma","KTE-C19-107","Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)","Diffuse Large B-Cell Lymphoma|Lymphoma|Lymphoma, B-Cell","Oncology Hematological","Oncology","Experimental|Active Comparator","Axicabtagene Ciloleucel Treatment|Standard of Care Therapy",null,"Drug","Axicabtagene Ciloleucel|Platinum-containing salvage chemotherapy (eg, R-ICE) followed by high dose therapy (eg, BEAM) and autologous stem cell transplant in responders.","Intervention Description: N/A.","KTE-C19 | axi-cel","Axicabtagene Ciloleucel Treatment|Standard of Care Therapy","\n\n 1. Histologically proven DLBCL, including transformation from follicular lymphoma\n 2. Relapsed or refractory disease after first-line chemoimmunotherapy * Refractory disease is defined as no complete remission to first-line therapy; subjects who are intolerant to first-line therapy are excluded. * Progressive disease (PD) as best response to first-line therapy\n        * Stable disease (SD) as best response after at least 4 cycles of first-line therapy\n        * Partial response (PR) as best response after at least 6 cycles and biopsy-proven residual disease or disease progression â‰¤ 12 months from initiation of therapy\n       \n       \n     * Relapsed disease defined as complete remission to first-line therapy followed by biopsy-proven relapse â‰¤ 12 months of initiating first-line therapy\n    \n    \n 3. Subjects must have received adequate first-line therapy including at a minimum: * Anti-CD20 monoclonal antibody unless investigator determines that tumor is CD20 negative, and\n     * An anthracycline containing chemotherapy regimen\n    \n    \n 4. No known history or suspicion of central nervous system involvement by lymphoma\n 5. ECOG performance status of 0 or 1\n 6. Adequate bone marrow function as evidenced by: * ANC â‰¥ 1000/uL\n     * Platelet â‰¥ 75,000/uL\n     * Absolute lymphocyte count â‰¥ 100/uL\n    \n    \n 7. Adequate renal, hepatic, cardiac, and pulmonary function as evidenced by: * Creatinine clearance (Cockcroft Gault) â‰¥ 60 mL/min\n     * Serum ALT/AST â‰¤ 2.5 ULN\n     * Total bilirubin â‰¤ 1.5 mg/dl\n     * Cardiac ejection fraction â‰¥ 50%, no evidence of pericardial effusion as determined by an ECHO, and no clinically significant ECG findings\n     * No clinically significant pleural effusion\n     * Baseline oxygen saturation > 92% on room air\n    \n    \n\nKey ","\n\n 1.  History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (eg cervix, bladder, breast) unless disease free for at least 3 years\n 2.  Received more than one line of therapy for DLBCL\n 3.  History of autologous or allogeneic stem cell transplant\n 4.  Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring intravenous antimicrobials for management.\n 5.  Known history of infection with human immunodeficiency virus (HIV) or hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive). If there is a positive history of treated hepatitis B or hepatitis C, the viral load must be undetectable per quantitative polymerase chain reaction (PCR) and/or nucleic acid testing.\n 6.  Subjects with detectable cerebrospinal fluid malignant cells or known brain metastases, or with a history of cerebrospinal fluid malignant cells or brain metastases.\n 7.  History or presence of non-malignant CNS disorder such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement\n 8.  Presence of any indwelling line or drain. Dedicated central venous access catheter such as a Port-a-Cath or Hickman catheter are permitted.\n 9.  History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, New York Heart Association Class II or greater congestive heart failure, or other clinically significant cardiac diseases within 12 months of enrollment\n 10. History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months of enrollment\n 11. History of autoimmune disease, requiring systemic immunosuppression and/or systemic disease modifying agents within the last 2 years\n 12. History of anti-CD19 or CAR-T therapy or history of prior randomization in ZUMA-7",{"$nulls":4},"Actual","2018-01-05","Actual","Anticipated","2035-01-15","Anticipated","2018-07-01","2017-12-21","2017-12-29","2018-07-30","Yes",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No","Yes",{"$nulls":3},"Yes","No",{"$nulls":19},"Event Free Survival",44197,null,"Objective Response Rate|Overall Survival","Jan 2021|Jan 2022",null,"medinfo@kitepharma.com","Kite MD",-6780,"Brussels, Belgium|Vancouver, British Columbia, Canada|Toronto, Ontario, Canada, M5G 2M9|Amsterdam, Netherlands, 1105 Az|Gilbert, Arizona, United States, 85234|San Diego, California, United States, 92093-0698|Miami, Florida, United States, 33136|Chicago, Illinois, United States, 60637|Iowa City, Iowa, United States, 52242|Kansas City, Kansas, United States, 66160|Baltimore, Maryland, United States, 21201|Boston, Massachusetts, United States, 02215|Rochester, Minnesota, United States, 55905|Saint Louis, Missouri, United States, 63130|Hackensack, New Jersey, United States, 07601|New York, New York, United States, 10065|Columbus, Ohio, United States, 43210|Pittsburgh, Pennsylvania, United States, 15213|Nashville, Tennessee, United States, 37203|Houston, Texas, United States, 77030|Charlottesville, Virginia, United States, 22908|Seattle, Washington, United States, 98104","Arizona|California|Florida|Illinois|Iowa|Kansas|Maryland|Massachusetts|Minnesota|Missouri|New Jersey|New York|Ohio|Pennsylvania|Tennessee|Texas|Virginia|Washington","Belgium|Canada|Netherlands|United States","Cliniques Universiaires Saint-Luc|British Columbia Vancouver General Hospital|Ontario Princess Margaret Hospital|Academic Medical Center Amsterdam|Banner Md Anderson Cancer Center|Uc San Diego Moores Cancer Center|University Of Miami|University Of Chicago|University Of Iowa|University Of Kansas Medical Center|University Of Maryland|Dana-Farber Cancer Institute|Mayo Clinic|Washington University|Hackensack University Medical Center|Memorial Sloan Kettering|The Ohio State University|University Of Pittsburgh Medical Center|Sarah Cannon Research Institute|Md Anderson Cancer Center|University Of Virginia Health System|Swedish Cancer Institute",{"$nulls":4},"2018-07-30","2020-05-25T16:35:19.873","2020-05-26T17:10:42.972","NCT03391466"]
["5ecbf3c811702c1b1b9169c1","NCT03391466","2018-08-08","Gilead Sciences","GILD","Recruiting","A Study Evaluating the Efficacy of Axicabtagene Ciloleucel Compared to Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma (ZUMA-7)","Axicabtagene ciloleucel|Autologous stem cell transplant","CAR-T|Autologous Cell Therapy","Yes","['Axicabtagene ciloleucel']","Yes","['CAR-T', 'Autologous Cell Therapy']","Phase 3",2,350,"Anticipated","2017-12-14","2022-01-15","EFS","Event Free Survival",{"$nulls":3},"The purpose of this study is to evaluate whether axicabtagene ciloleucel therapy improves the clinical outcome compared with standard of care second-line therapy in patients with relapsed/refractory DLBCL.","This is a phase 3 randomized, open-label, multicenter study evaluating the efficacy of axicabtagene ciloleucel versus standard of care therapy in subjects with relapsed/refractory DLBCL. Adult subjects with relapsed/refractory DLBCL after first-line rituximab and anthracycline-based chemotherapy will be randomized in a 1:1 ratio to receive axicabtagene ciloleucel or standard of care second-line therapy.\n\nStandard of care will consist of a protocol-defined, platinum-based salvage combination chemotherapy regimen followed by high-dose therapy and autologous stem cell transplant in those who respond to salvage chemotherapy.","A Phase 3, Randomized, Open-Label Study Evaluating Efficacy of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma","KTE-C19-107","Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)","Diffuse Large B-Cell Lymphoma|Lymphoma|Lymphoma, B-Cell","Oncology Hematological","Oncology","Experimental|Active Comparator","Axicabtagene Ciloleucel Treatment|Standard of Care Therapy",null,"Drug","Axicabtagene Ciloleucel|Platinum-containing salvage chemotherapy (eg, R-ICE) followed by high dose therapy (eg, BEAM) and autologous stem cell transplant in responders.","Intervention Description: N/A.","KTE-C19 | axi-cel","Axicabtagene Ciloleucel Treatment|Standard of Care Therapy","\n\n 1. Histologically proven DLBCL, including transformation from follicular lymphoma\n 2. Relapsed or refractory disease after first-line chemoimmunotherapy * Refractory disease is defined as no complete remission to first-line therapy; subjects who are intolerant to first-line therapy are excluded. * Progressive disease (PD) as best response to first-line therapy\n        * Stable disease (SD) as best response after at least 4 cycles of first-line therapy\n        * Partial response (PR) as best response after at least 6 cycles and biopsy-proven residual disease or disease progression â‰¤ 12 months from initiation of therapy\n       \n       \n     * Relapsed disease defined as complete remission to first-line therapy followed by biopsy-proven relapse â‰¤ 12 months of initiating first-line therapy\n    \n    \n 3. Subjects must have received adequate first-line therapy including at a minimum: * Anti-CD20 monoclonal antibody unless investigator determines that tumor is CD20 negative, and\n     * An anthracycline containing chemotherapy regimen\n    \n    \n 4. No known history or suspicion of central nervous system involvement by lymphoma\n 5. ECOG performance status of 0 or 1\n 6. Adequate bone marrow function as evidenced by: * ANC â‰¥ 1000/uL\n     * Platelet â‰¥ 75,000/uL\n     * Absolute lymphocyte count â‰¥ 100/uL\n    \n    \n 7. Adequate renal, hepatic, cardiac, and pulmonary function as evidenced by: * Creatinine clearance (Cockcroft Gault) â‰¥ 60 mL/min\n     * Serum ALT/AST â‰¤ 2.5 ULN\n     * Total bilirubin â‰¤ 1.5 mg/dl\n     * Cardiac ejection fraction â‰¥ 50%, no evidence of pericardial effusion as determined by an ECHO, and no clinically significant ECG findings\n     * No clinically significant pleural effusion\n     * Baseline oxygen saturation > 92% on room air\n    \n    \n\nKey ","\n\n 1.  History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (eg cervix, bladder, breast) unless disease free for at least 3 years\n 2.  Received more than one line of therapy for DLBCL\n 3.  History of autologous or allogeneic stem cell transplant\n 4.  Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring intravenous antimicrobials for management.\n 5.  Known history of infection with human immunodeficiency virus (HIV) or hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive). If there is a positive history of treated hepatitis B or hepatitis C, the viral load must be undetectable per quantitative polymerase chain reaction (PCR) and/or nucleic acid testing.\n 6.  Subjects with detectable cerebrospinal fluid malignant cells or known brain metastases, or with a history of cerebrospinal fluid malignant cells or brain metastases.\n 7.  History or presence of non-malignant CNS disorder such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement\n 8.  Presence of any indwelling line or drain. Dedicated central venous access catheter such as a Port-a-Cath or Hickman catheter are permitted.\n 9.  History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, New York Heart Association Class II or greater congestive heart failure, or other clinically significant cardiac diseases within 12 months of enrollment\n 10. History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months of enrollment\n 11. History of autoimmune disease, requiring systemic immunosuppression and/or systemic disease modifying agents within the last 2 years\n 12. History of anti-CD19 or CAR-T therapy or history of prior randomization in ZUMA-7",{"$nulls":4},"Actual","2018-01-05","Actual","Anticipated","2035-01-15","Anticipated","2018-08-01","2017-12-21","2017-12-29","2018-08-06","Yes",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No","Yes",{"$nulls":3},"Yes","No",{"$nulls":19},"Event Free Survival",44197,null,"Objective Response Rate|Overall Survival","Jan 2021|Jan 2022",null,"medinfo@kitepharma.com","Kite MD",-6780,"Brussels, Belgium|Vancouver, British Columbia, Canada|Toronto, Ontario, Canada, M5G 2M9|Amsterdam, Netherlands, 1105 Az|Gilbert, Arizona, United States, 85234|San Diego, California, United States, 92093-0698|Miami, Florida, United States, 33136|Chicago, Illinois, United States, 60637|Iowa City, Iowa, United States, 52242|Kansas City, Kansas, United States, 66160|Baltimore, Maryland, United States, 21201|Boston, Massachusetts, United States, 02215|Rochester, Minnesota, United States, 55905|Saint Louis, Missouri, United States, 63130|Hackensack, New Jersey, United States, 07601|New York, New York, United States, 10065|Cleveland, Ohio, United States, 44195|Pittsburgh, Pennsylvania, United States, 15213|Nashville, Tennessee, United States, 37203|Houston, Texas, United States, 77030|Charlottesville, Virginia, United States, 22908|Seattle, Washington, United States, 98104","Arizona|California|Florida|Illinois|Iowa|Kansas|Maryland|Massachusetts|Minnesota|Missouri|New Jersey|New York|Ohio|Pennsylvania|Tennessee|Texas|Virginia|Washington","Belgium|Canada|Netherlands|United States","Cliniques Universiaires Saint-Luc|British Columbia Vancouver General Hospital|Ontario Princess Margaret Hospital|Academic Medical Center Amsterdam|Banner Md Anderson Cancer Center|Uc San Diego Moores Cancer Center|University Of Miami|University Of Chicago|University Of Iowa|University Of Kansas Medical Center|University Of Maryland|Dana-Farber Cancer Institute|Mayo Clinic|Washington University|Hackensack University Medical Center|Memorial Sloan Kettering|Cleveland Clinic|University Of Pittsburgh Medical Center|Sarah Cannon Research Institute|Md Anderson Cancer Center|University Of Virginia Health System|Swedish Cancer Institute",{"$nulls":4},"2018-08-06","2020-05-25T16:35:20.218","2020-05-26T17:10:42.972","NCT03391466"]
["5ecbf3c8e2561b1b11905ca9","NCT03391466","2018-09-14","Gilead Sciences","GILD","Recruiting","A Study Evaluating the Efficacy of Axicabtagene Ciloleucel Compared to Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma (ZUMA-7)","Axicabtagene ciloleucel|Autologous stem cell transplant","CAR-T|Autologous Cell Therapy","Yes","['Axicabtagene ciloleucel']","Yes","['CAR-T', 'Autologous Cell Therapy']","Phase 3",2,350,"Anticipated","2017-12-14","2022-01-15","EFS","Event Free Survival",{"$nulls":3},"The purpose of this study is to evaluate whether axicabtagene ciloleucel therapy improves the clinical outcome compared with standard of care second-line therapy in patients with relapsed/refractory DLBCL.","This is a phase 3 randomized, open-label, multicenter study evaluating the efficacy of axicabtagene ciloleucel versus standard of care therapy in subjects with relapsed/refractory DLBCL. Adult subjects with relapsed/refractory DLBCL after first-line rituximab and anthracycline-based chemotherapy will be randomized in a 1:1 ratio to receive axicabtagene ciloleucel or standard of care second-line therapy.\n\nStandard of care will consist of a protocol-defined, platinum-based salvage combination chemotherapy regimen followed by high-dose therapy and autologous stem cell transplant in those who respond to salvage chemotherapy.","A Phase 3, Randomized, Open-Label Study Evaluating Efficacy of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma","KTE-C19-107","Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)","Diffuse Large B-Cell Lymphoma|Lymphoma|Lymphoma, B-Cell","Oncology Hematological","Oncology","Experimental|Active Comparator","Axicabtagene Ciloleucel Treatment|Standard of Care Therapy",null,"Drug","Axicabtagene Ciloleucel|Platinum-containing salvage chemotherapy (eg, R-ICE) followed by high dose therapy (eg, BEAM) and autologous stem cell transplant in responders.","Intervention Description: N/A.","KTE-C19 | axi-cel","Axicabtagene Ciloleucel Treatment|Standard of Care Therapy","\n\n 1. Histologically proven DLBCL, including transformation from follicular lymphoma\n 2. Relapsed or refractory disease after first-line chemoimmunotherapy * Refractory disease is defined as no complete remission to first-line therapy; subjects who are intolerant to first-line therapy are excluded. * Progressive disease (PD) as best response to first-line therapy\n        * Stable disease (SD) as best response after at least 4 cycles of first-line therapy\n        * Partial response (PR) as best response after at least 6 cycles and biopsy-proven residual disease or disease progression â‰¤ 12 months from initiation of therapy\n       \n       \n     * Relapsed disease defined as complete remission to first-line therapy followed by biopsy-proven relapse â‰¤ 12 months of initiating first-line therapy\n    \n    \n 3. Subjects must have received adequate first-line therapy including at a minimum: * Anti-CD20 monoclonal antibody unless investigator determines that tumor is CD20 negative, and\n     * An anthracycline containing chemotherapy regimen\n    \n    \n 4. No known history or suspicion of central nervous system involvement by lymphoma\n 5. ECOG performance status of 0 or 1\n 6. Adequate bone marrow function as evidenced by: * ANC â‰¥ 1000/uL\n     * Platelet â‰¥ 75,000/uL\n     * Absolute lymphocyte count â‰¥ 100/uL\n    \n    \n 7. Adequate renal, hepatic, cardiac, and pulmonary function as evidenced by: * Creatinine clearance (Cockcroft Gault) â‰¥ 60 mL/min\n     * Serum ALT/AST â‰¤ 2.5 ULN\n     * Total bilirubin â‰¤ 1.5 mg/dl\n     * Cardiac ejection fraction â‰¥ 50%, no evidence of pericardial effusion as determined by an ECHO, and no clinically significant ECG findings\n     * No clinically significant pleural effusion\n     * Baseline oxygen saturation > 92% on room air\n    \n    \n\nKey ","\n\n 1.  History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (eg cervix, bladder, breast) unless disease free for at least 3 years\n 2.  Received more than one line of therapy for DLBCL\n 3.  History of autologous or allogeneic stem cell transplant\n 4.  Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring intravenous antimicrobials for management.\n 5.  Known history of infection with human immunodeficiency virus (HIV) or hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive). If there is a positive history of treated hepatitis B or hepatitis C, the viral load must be undetectable per quantitative polymerase chain reaction (PCR) and/or nucleic acid testing.\n 6.  Subjects with detectable cerebrospinal fluid malignant cells or known brain metastases, or with a history of cerebrospinal fluid malignant cells or brain metastases.\n 7.  History or presence of non-malignant CNS disorder such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement\n 8.  Presence of any indwelling line or drain. Dedicated central venous access catheter such as a Port-a-Cath or Hickman catheter are permitted.\n 9.  History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, New York Heart Association Class II or greater congestive heart failure, or other clinically significant cardiac diseases within 12 months of enrollment\n 10. History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months of enrollment\n 11. History of autoimmune disease, requiring systemic immunosuppression and/or systemic disease modifying agents within the last 2 years\n 12. History of anti-CD19 or CAR-T therapy or history of prior randomization in ZUMA-7",{"$nulls":4},"Actual","2018-01-05","Actual","Anticipated","2035-01-15","Anticipated","2018-09-01","2017-12-21","2017-12-29","2018-09-13","Yes",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No","Yes",{"$nulls":3},"Yes","No",{"$nulls":19},"Event Free Survival",44197,null,"Objective Response Rate|Overall Survival","Jan 2021|Jan 2022",null,"medinfo@kitepharma.com","Kite MD",-6780,"Brussels, Belgium|Vancouver, British Columbia, Canada|Winnipeg, Manitoba, Canada, R3E 0V9|Toronto, Ontario, Canada, M5G 2M9|Amsterdam, Netherlands, 1105 Az|Barcelona, Spain, 08908|Gilbert, Arizona, United States, 85234|San Diego, California, United States, 92093-0698|Miami, Florida, United States, 33136|Chicago, Illinois, United States, 60637|Iowa City, Iowa, United States, 52242|Kansas City, Kansas, United States, 66160|Baltimore, Maryland, United States, 21201|Boston, Massachusetts, United States, 02215|Rochester, Minnesota, United States, 55905|Saint Louis, Missouri, United States, 63130|Hackensack, New Jersey, United States, 07601|New York, New York, United States, 10065|Cleveland, Ohio, United States, 44195|Pittsburgh, Pennsylvania, United States, 15213|Nashville, Tennessee, United States, 37203|Houston, Texas, United States, 77030|Charlottesville, Virginia, United States, 22908|Seattle, Washington, United States, 98104","Arizona|California|Florida|Illinois|Iowa|Kansas|Maryland|Massachusetts|Minnesota|Missouri|New Jersey|New York|Ohio|Pennsylvania|Tennessee|Texas|Virginia|Washington","Belgium|Canada|Netherlands|Spain|United States","Cliniques Universiaires Saint-Luc|British Columbia Vancouver General Hospital|Manitoba Cancercare Manitoba|Ontario Princess Margaret Hospital|Academic Medical Center Amsterdam|Institut Catala D'Oncologia De L'Hospitalet|Banner Md Anderson Cancer Center|Uc San Diego Moores Cancer Center|University Of Miami|University Of Chicago|University Of Iowa|University Of Kansas Medical Center|University Of Maryland|Dana-Farber Cancer Institute|Mayo Clinic|Washington University|Hackensack University Medical Center|Memorial Sloan Kettering|Cleveland Clinic|University Of Pittsburgh Medical Center|Sarah Cannon Research Institute|Md Anderson Cancer Center|University Of Virginia Health System|Swedish Cancer Institute",{"$nulls":4},"2018-09-13","2020-05-25T16:35:20.073","2020-05-26T17:10:42.972","NCT03391466"]
["5ecbf3c8feab101b155307dd","NCT03391466","2018-09-19","Gilead Sciences","GILD","Recruiting","A Study Evaluating the Efficacy of Axicabtagene Ciloleucel Compared to Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma (ZUMA-7)","Axicabtagene ciloleucel|Autologous stem cell transplant","CAR-T|Autologous Cell Therapy","Yes","['Axicabtagene ciloleucel']","Yes","['CAR-T', 'Autologous Cell Therapy']","Phase 3",2,350,"Anticipated","2017-12-14","2022-01-15","EFS","Event Free Survival",{"$nulls":3},"The purpose of this study is to evaluate whether axicabtagene ciloleucel therapy improves the clinical outcome compared with standard of care second-line therapy in patients with relapsed/refractory DLBCL.","This is a phase 3 randomized, open-label, multicenter study evaluating the efficacy of axicabtagene ciloleucel versus standard of care therapy in subjects with relapsed/refractory DLBCL. Adult subjects with relapsed/refractory DLBCL after first-line rituximab and anthracycline-based chemotherapy will be randomized in a 1:1 ratio to receive axicabtagene ciloleucel or standard of care second-line therapy.\n\nStandard of care will consist of a protocol-defined, platinum-based salvage combination chemotherapy regimen followed by high-dose therapy and autologous stem cell transplant in those who respond to salvage chemotherapy.","A Phase 3, Randomized, Open-Label Study Evaluating Efficacy of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma","KTE-C19-107","Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)","Diffuse Large B-Cell Lymphoma|Lymphoma|Lymphoma, B-Cell","Oncology Hematological","Oncology","Experimental|Active Comparator","Axicabtagene Ciloleucel Treatment|Standard of Care Therapy",null,"Drug","Axicabtagene Ciloleucel|Platinum-containing salvage chemotherapy (eg, R-ICE) followed by high dose therapy (eg, BEAM) and autologous stem cell transplant in responders.","Intervention Description: N/A.","KTE-C19 | axi-cel","Axicabtagene Ciloleucel Treatment|Standard of Care Therapy","\n\n 1. Histologically proven DLBCL, including transformation from follicular lymphoma\n 2. Relapsed or refractory disease after first-line chemoimmunotherapy * Refractory disease is defined as no complete remission to first-line therapy; subjects who are intolerant to first-line therapy are excluded. * Progressive disease (PD) as best response to first-line therapy\n        * Stable disease (SD) as best response after at least 4 cycles of first-line therapy\n        * Partial response (PR) as best response after at least 6 cycles and biopsy-proven residual disease or disease progression â‰¤ 12 months from initiation of therapy\n       \n       \n     * Relapsed disease defined as complete remission to first-line therapy followed by biopsy-proven relapse â‰¤ 12 months of initiating first-line therapy\n    \n    \n 3. Subjects must have received adequate first-line therapy including at a minimum: * Anti-CD20 monoclonal antibody unless investigator determines that tumor is CD20 negative, and\n     * An anthracycline containing chemotherapy regimen\n    \n    \n 4. No known history or suspicion of central nervous system involvement by lymphoma\n 5. ECOG performance status of 0 or 1\n 6. Adequate bone marrow function as evidenced by: * ANC â‰¥ 1000/uL\n     * Platelet â‰¥ 75,000/uL\n     * Absolute lymphocyte count â‰¥ 100/uL\n    \n    \n 7. Adequate renal, hepatic, cardiac, and pulmonary function as evidenced by: * Creatinine clearance (Cockcroft Gault) â‰¥ 60 mL/min\n     * Serum ALT/AST â‰¤ 2.5 ULN\n     * Total bilirubin â‰¤ 1.5 mg/dl\n     * Cardiac ejection fraction â‰¥ 50%, no evidence of pericardial effusion as determined by an ECHO, and no clinically significant ECG findings\n     * No clinically significant pleural effusion\n     * Baseline oxygen saturation > 92% on room air\n    \n    \n\nKey ","\n\n 1.  History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (eg cervix, bladder, breast) unless disease free for at least 3 years\n 2.  Received more than one line of therapy for DLBCL\n 3.  History of autologous or allogeneic stem cell transplant\n 4.  Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring intravenous antimicrobials for management.\n 5.  Known history of infection with human immunodeficiency virus (HIV) or hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive). If there is a positive history of treated hepatitis B or hepatitis C, the viral load must be undetectable per quantitative polymerase chain reaction (PCR) and/or nucleic acid testing.\n 6.  Subjects with detectable cerebrospinal fluid malignant cells or known brain metastases, or with a history of cerebrospinal fluid malignant cells or brain metastases.\n 7.  History or presence of non-malignant CNS disorder such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement\n 8.  Presence of any indwelling line or drain. Dedicated central venous access catheter such as a Port-a-Cath or Hickman catheter are permitted.\n 9.  History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, New York Heart Association Class II or greater congestive heart failure, or other clinically significant cardiac diseases within 12 months of enrollment\n 10. History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months of enrollment\n 11. History of autoimmune disease, requiring systemic immunosuppression and/or systemic disease modifying agents within the last 2 years\n 12. History of anti-CD19 or CAR-T therapy or history of prior randomization in ZUMA-7",{"$nulls":4},"Actual","2018-01-05","Actual","Anticipated","2035-01-15","Anticipated","2018-09-01","2017-12-21","2017-12-29","2018-09-17","Yes",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No","Yes",{"$nulls":3},"Yes","No",{"$nulls":19},"Event Free Survival",44197,null,"Objective Response Rate|Overall Survival","Jan 2021|Jan 2022",null,"medinfo@kitepharma.com","Kite MD",-6780,"Brussels, Belgium|Vancouver, British Columbia, Canada|Winnipeg, Manitoba, Canada, R3E 0V9|Toronto, Ontario, Canada, M5G 2M9|Amsterdam, Netherlands, 1105 Az|Barcelona, Spain, 08908|Gilbert, Arizona, United States, 85234|San Diego, California, United States, 92093-0698|Miami, Florida, United States, 33136|Chicago, Illinois, United States, 60637|Iowa City, Iowa, United States, 52242|Kansas City, Kansas, United States, 66160|Baltimore, Maryland, United States, 21201|Boston, Massachusetts, United States, 02215|Rochester, Minnesota, United States, 55905|Saint Louis, Missouri, United States, 63130|Hackensack, New Jersey, United States, 07601|New York, New York, United States, 10029|Cleveland, Ohio, United States, 44195|Pittsburgh, Pennsylvania, United States, 15213|Nashville, Tennessee, United States, 37203|Houston, Texas, United States, 77030|Charlottesville, Virginia, United States, 22908|Seattle, Washington, United States, 98104","Arizona|California|Florida|Illinois|Iowa|Kansas|Maryland|Massachusetts|Minnesota|Missouri|New Jersey|New York|Ohio|Pennsylvania|Tennessee|Texas|Virginia|Washington","Belgium|Canada|Netherlands|Spain|United States","Cliniques Universiaires Saint-Luc|British Columbia Vancouver General Hospital|Manitoba Cancercare Manitoba|Ontario Princess Margaret Hospital|Academic Medical Center Amsterdam|Institut Catala D'Oncologia De L'Hospitalet|Banner Md Anderson Cancer Center|Uc San Diego Moores Cancer Center|University Of Miami|University Of Chicago|University Of Iowa|University Of Kansas Medical Center|University Of Maryland|Dana-Farber Cancer Institute|Mayo Clinic|Washington University|Hackensack University Medical Center|Icahn School Of Medicine At Mount Sinai|Cleveland Clinic|University Of Pittsburgh Medical Center|Sarah Cannon Research Institute|Md Anderson Cancer Center|University Of Virginia Health System|Swedish Cancer Institute",{"$nulls":4},"2018-09-17","2020-05-25T16:35:20.077","2020-05-26T17:10:42.972","NCT03391466"]
["5ecbf3c8fe30261b1a0481ae","NCT03391466","2018-12-10","Gilead Sciences","GILD","Recruiting","Efficacy of Axicabtagene Ciloleucel Compared to Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma (ZUMA-7)","Axicabtagene ciloleucel|Cyclophosphamide|Fludarabine|Autologous stem cell transplant","CAR-T|Immunomodulator|STAT1 Inhibitor|Autologous Cell Therapy","Yes","['Axicabtagene ciloleucel']","Yes","['CAR-T', 'Autologous Cell Therapy']","Phase 3",2,350,"Anticipated","2017-12-14","2022-01-15","EFS","Event Free Survival",{"$nulls":3},"The purpose of this study is to evaluate whether axicabtagene ciloleucel therapy improves the clinical outcome compared with standard of care second-line therapy in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL).","This is a phase 3 randomized, open-label, multicenter study evaluating the efficacy of axicabtagene ciloleucel versus standard of care therapy in subjects with relapsed/refractory DLBCL. Adult subjects with relapsed/refractory DLBCL after first-line rituximab and anthracycline-based chemotherapy will be randomized in a 1:1 ratio to receive axicabtagene ciloleucel or standard of care second-line therapy.\n\nStandard of care will consist of a protocol-defined, platinum-based salvage combination chemotherapy regimen followed by high-dose therapy and autologous stem cell transplant in those who respond to salvage chemotherapy.","A Phase 3, Randomized, Open-Label Study Evaluating Efficacy of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma","KTE-C19-107","Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)","Diffuse Large B-Cell Lymphoma|Lymphoma|Lymphoma, B-Cell","Oncology Hematological","Oncology","Experimental|Active Comparator","Axicabtagene Ciloleucel Treatment|Standard of Care Therapy",null,"Biological|Drug","Axicabtagene Ciloleucel|Cyclophosphamide|Fludarabine|Platinum-containing salvage chemotherapy (eg, R-ICE) followed by high dose therapy (eg, BEAM) and autologous stem cell transplant in responders.","A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells administered intravenously following a conditioning chemotherapy regimen of fludarabine and cyclophosphamide|Administered intravenously|Platinum-containing salvage chemotherapy (R-ICE, R-DHAP, R-ESHAP, or R-GDP as selected by treating investigator) followed by high dose therapy (eg, BEAM) and autologous stem cell transplant in responders.","KTE-C19 | axi-cel","Axicabtagene Ciloleucel Treatment|Standard of Care Therapy","\n\n 1. Histologically proven DLBCL, including transformation from follicular lymphoma\n 2. Relapsed or refractory disease after first-line chemoimmunotherapy * Refractory disease is defined as no complete remission to first-line therapy; individuals who are intolerant to first-line therapy are excluded. * Progressive disease (PD) as best response to first-line therapy\n        * Stable disease (SD) as best response after at least 4 cycles of first-line therapy\n        * Partial response (PR) as best response after at least 6 cycles and biopsy-proven residual disease or disease progression â‰¤ 12 months from initiation of therapy\n       \n       \n     * Relapsed disease defined as complete remission to first-line therapy followed by biopsy-proven relapse â‰¤ 12 months of initiating first-line therapy\n    \n    \n 3. Individuals must have received adequate first-line therapy including at a minimum: * Anti-CD20 monoclonal antibody unless investigator determines that tumor is CD20 negative, and\n     * An anthracycline containing chemotherapy regimen\n    \n    \n 4. No known history or suspicion of central nervous system involvement by lymphoma\n 5. Eastern cooperative oncology group (ECOG) performance status of 0 or 1\n 6. Adequate bone marrow function as evidenced by: * Absolute neutrophil count (ANC) â‰¥ 1000/uL\n     * Platelet â‰¥ 75,000/uL\n     * Absolute lymphocyte count â‰¥ 100/uL\n    \n    \n 7. Adequate renal, hepatic, cardiac, and pulmonary function as evidenced by: * Creatinine clearance (Cockcroft Gault) â‰¥ 60 mL/min\n     * Serum Alanine aminotransferase/Aspartate aminotransferase (ALT/AST) â‰¤ 2.5 Upper limit of normal (ULN)\n     * Total bilirubin â‰¤ 1.5 mg/dl\n     * Cardiac ejection fraction â‰¥ 50%, no evidence of pericardial effusion as determined by an Echocardiogram (ECHO), and no clinically significant Electrocardiogram (ECG) findings\n     * No clinically significant pleural effusion\n     * Baseline oxygen saturation > 92% on room air\n    \n    \n\nKey ","\n\n 1.  History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (eg cervix, bladder, breast) unless disease free for at least 3 years\n 2.  Received more than one line of therapy for DLBCL\n 3.  History of autologous or allogeneic stem cell transplant\n 4.  Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring intravenous antimicrobials for management.\n 5.  Known history of infection with human immunodeficiency virus (HIV) or hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive). If there is a positive history of treated hepatitis B or hepatitis C, the viral load must be undetectable per quantitative polymerase chain reaction (PCR) and/or nucleic acid testing.\n 6.  Individuals with detectable cerebrospinal fluid malignant cells or known brain metastases, or with a history of cerebrospinal fluid malignant cells or brain metastases.\n 7.  History or presence of non-malignant central nervous system (CNS) disorder such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement\n 8.  Presence of any indwelling line or drain. Dedicated central venous access catheter such as a Port-a-Cath or Hickman catheter are permitted.\n 9.  History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, New York Heart Association Class II or greater congestive heart failure, or other clinically significant cardiac diseases within 12 months of enrollment\n 10. History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months of enrollment\n 11. History of autoimmune disease, requiring systemic immunosuppression and/or systemic disease modifying agents within the last 2 years\n 12. History of anti-CD19 or CAR-T therapy or history of prior randomization in ZUMA-7\n\nNote: Other protocol defined Inclusion/Exclusion criteria may apply",{"$nulls":4},"Actual","2018-01-05","Actual","Anticipated","2035-01-15","Anticipated","2018-12-01","2017-12-21","2017-12-29","2018-12-06","Yes",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No","Yes","Cheson BD, Fisher RI, Barrington SF, Cavalli F, Schwartz LH, Zucca E, Lister TA; Alliance, Australasian Leukaemia and Lymphoma Group; Eastern Cooperative Oncology Group; European Mantle Cell Lymphoma Consortium; Italian Lymphoma Foundation; European Organisation for Research; Treatment of Cancer/Dutch Hemato-Oncology Group; Grupo EspaÃ±ol de MÃ©dula Ã“sea; German High-Grade Lymphoma Study Group; German Hodgkin's Study Group; Japanese Lymphorra Study Group; Lymphoma Study Association; NCIC Clinical Trials Group; Nordic Lymphoma Study Group; Southwest Oncology Group; United Kingdom National Cancer Research Institute. Recommendations for initial evaluation, staging, and response assessment of Hodgkin and non-Hodgkin lymphoma: the Lugano classification. J Clin Oncol. 2014 Sep 20;32(27):3059-68. PubMed 25113753",null,null,"Yes","No",{"$nulls":17},"2017-002261-22","EudraCT Number","Event Free Survival","Event free survival is defined as the time from randomization to the earliest date of disease progression per Lugano Classification (Cheson et al, 2014), commencement of new lymphoma therapy, or death from any cause as determined by blinded central review","Up to 5 years","Objective Response Rate (ORR)|Overall Survival","Objective response rate is defined as the incidence of either a complete response or a partial response by the Lugano Classification (Cheson et al, 2014) as determined by blinded central review|Overall survival is defined as the time from randomization to death from any cause","Up to 5 years","medinfo@kitepharma.com","Medical Information","844-454-KITE","Brussels, BelgiumPrincipal Investigator: Xavier PoirÃ©, Md Uz Leuven GasthuisbertLeuven, BelgiumPrincipal Investigator: Peter Vandenberghe, Md, Phd|Vancouver, British Columbia, Canada|Winnipeg, Manitoba, Canada, R3E 0V9|Toronto, Ontario, Canada, M5G 2M9|Ottawa, Canada, K1H 8L6Principal Investigator: Natasha Kekre, Md|Paris, France, 75475Principal Investigator: Catherine Thieblmont, Md, Phd|Tel Aviv, Israel, 62431Principal Investigator: Irit Avivi, Md|Amsterdam, Netherlands, 1105 AzPrincipal Investigator: Marie JosÃ© Kersten, Md, Phd University Medical Center GroningenGroningen, Netherlands, 9700 RbPrincipal Investigator: Tom Van Meerten, Md, Phd Universitair Mendisch Centrum UtrechtUtrecht, NetherlandsPrincipal Investigator: Monique Minnema, Md, Phd|Barcelona, Spain, 08036Principal Investigator: Armando LÃ³pez-Guillermo, Md, Phd Institut Catala D'Oncologia De L'HospitaletBarcelona, Spain, 08908|Birmingham, United Kingdom, B15 2GwPrincipal Investigator: Sridhar Chaganti, Md The Christie Nhs Foundation TrustManchester, United Kingdom, M20 4BxPrincipal Investigator: John Radford, Md The Royal Marsden Nhs Foundation TrustSutton, United Kingdom, Sm2 5PtPrincipal Investigator: David Cunningham, Md|Gilbert, Arizona, United States, 85234|San Diego, California, United States, 92093-0698|Miami, Florida, United States, 33136|Chicago, Illinois, United States, 60612Principal Investigator: Reem Karmali, Md University Of ChicagoChicago, Illinois, United States, 60637|Iowa City, Iowa, United States, 52242|Kansas City, Kansas, United States, 66160|Baltimore, Maryland, United States, 21201|Boston, Massachusetts, United States, 02215|Detroit, Michigan, United States, 48201Principal Investigator: Abhinav Deol, Md|Rochester, Minnesota, United States, 55905|Saint Louis, Missouri, United States, 63130|Hackensack, New Jersey, United States, 07601|New York, New York, United States, 10029|Cleveland, Ohio, United States, 44195|Pittsburgh, Pennsylvania, United States, 15213|Nashville, Tennessee, United States, 37203|Houston, Texas, United States, 77030|Salt Lake City, Utah, United States, 84112Principal Investigator: Catherine Lee, Md|Charlottesville, Virginia, United States, 22908|Seattle, Washington, United States, 98104","Arizona|California|Florida|Illinois|Iowa|Kansas|Maryland|Massachusetts|Michigan|Minnesota|Missouri|New Jersey|New York|Ohio|Pennsylvania|Tennessee|Texas|Utah|Virginia|Washington","Belgium|Canada|France|Israel|Netherlands|Spain|United Kingdom|United States","Cliniques Universiaires Saint-Luc|British Columbia Vancouver General Hospital|Manitoba Cancercare Manitoba|Ontario Princess Margaret Hospital|The Ottawa Hospital - General Campus|Hopital Saint-Louis|Tel Aviv Souraski Medical Center|Academic Medical Center Amsterdam|Hospital Clinic De Barcelona|University Hospitals Birmingham Nhs Foundation Trust|Banner Md Anderson Cancer Center|Uc San Diego Moores Cancer Center|University Of Miami|Northwestern University|University Of Iowa|University Of Kansas Medical Center|University Of Maryland|Dana-Farber Cancer Institute|Karmanos Cancer Institute|Mayo Clinic|Washington University|Hackensack University Medical Center|Icahn School Of Medicine At Mount Sinai|Cleveland Clinic|University Of Pittsburgh Medical Center|Sarah Cannon Research Institute|Md Anderson Cancer Center|Huntsman Cancer Institute|University Of Virginia Health System|Swedish Cancer Institute",{"$nulls":3},"Kite Study Director","2018-12-06","2020-05-25T16:35:20.388","2020-05-26T17:10:42.972","NCT03391466"]
["5ecbf3c8307e3d1b1f8d9c3f","NCT03391466","2018-12-19","Gilead Sciences","GILD","Recruiting","Efficacy of Axicabtagene Ciloleucel Compared to Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma (ZUMA-7)","Axicabtagene ciloleucel|Cyclophosphamide|Fludarabine|Autologous stem cell transplant","CAR-T|Immunomodulator|STAT1 Inhibitor|Autologous Cell Therapy","Yes","['Axicabtagene ciloleucel']","Yes","['CAR-T', 'Autologous Cell Therapy']","Phase 3",2,350,"Anticipated","2017-12-14","2022-01-15","EFS","Event Free Survival",{"$nulls":3},"The purpose of this study is to evaluate whether axicabtagene ciloleucel therapy improves the clinical outcome compared with standard of care second-line therapy in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL).","This is a phase 3 randomized, open-label, multicenter study evaluating the efficacy of axicabtagene ciloleucel versus standard of care therapy in subjects with relapsed/refractory DLBCL. Adult subjects with relapsed/refractory DLBCL after first-line rituximab and anthracycline-based chemotherapy will be randomized in a 1:1 ratio to receive axicabtagene ciloleucel or standard of care second-line therapy.\n\nStandard of care will consist of a protocol-defined, platinum-based salvage combination chemotherapy regimen followed by high-dose therapy and autologous stem cell transplant in those who respond to salvage chemotherapy.","A Phase 3, Randomized, Open-Label Study Evaluating Efficacy of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma","KTE-C19-107","Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)","Diffuse Large B-Cell Lymphoma|Lymphoma|Lymphoma, B-Cell","Oncology Hematological","Oncology","Experimental|Active Comparator","Axicabtagene Ciloleucel Treatment|Standard of Care Therapy",null,"Biological|Drug","Axicabtagene Ciloleucel|Cyclophosphamide|Fludarabine|Platinum-containing salvage chemotherapy (eg, R-ICE) followed by high dose therapy (eg, BEAM) and autologous stem cell transplant in responders.","A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells administered intravenously following a conditioning chemotherapy regimen of fludarabine and cyclophosphamide|Administered intravenously|Platinum-containing salvage chemotherapy (R-ICE, R-DHAP, R-ESHAP, or R-GDP as selected by treating investigator) followed by high dose therapy (eg, BEAM) and autologous stem cell transplant in responders.","KTE-C19 | axi-cel","Axicabtagene Ciloleucel Treatment|Standard of Care Therapy","\n\n 1. Histologically proven DLBCL, including transformation from follicular lymphoma\n 2. Relapsed or refractory disease after first-line chemoimmunotherapy * Refractory disease is defined as no complete remission to first-line therapy; individuals who are intolerant to first-line therapy are excluded. * Progressive disease (PD) as best response to first-line therapy\n        * Stable disease (SD) as best response after at least 4 cycles of first-line therapy\n        * Partial response (PR) as best response after at least 6 cycles and biopsy-proven residual disease or disease progression â‰¤ 12 months from initiation of therapy\n       \n       \n     * Relapsed disease defined as complete remission to first-line therapy followed by biopsy-proven relapse â‰¤ 12 months of initiating first-line therapy\n    \n    \n 3. Individuals must have received adequate first-line therapy including at a minimum: * Anti-CD20 monoclonal antibody unless investigator determines that tumor is CD20 negative, and\n     * An anthracycline containing chemotherapy regimen\n    \n    \n 4. No known history or suspicion of central nervous system involvement by lymphoma\n 5. Eastern cooperative oncology group (ECOG) performance status of 0 or 1\n 6. Adequate bone marrow function as evidenced by: * Absolute neutrophil count (ANC) â‰¥ 1000/uL\n     * Platelet â‰¥ 75,000/uL\n     * Absolute lymphocyte count â‰¥ 100/uL\n    \n    \n 7. Adequate renal, hepatic, cardiac, and pulmonary function as evidenced by: * Creatinine clearance (Cockcroft Gault) â‰¥ 60 mL/min\n     * Serum Alanine aminotransferase/Aspartate aminotransferase (ALT/AST) â‰¤ 2.5 Upper limit of normal (ULN)\n     * Total bilirubin â‰¤ 1.5 mg/dl\n     * Cardiac ejection fraction â‰¥ 50%, no evidence of pericardial effusion as determined by an Echocardiogram (ECHO), and no clinically significant Electrocardiogram (ECG) findings\n     * No clinically significant pleural effusion\n     * Baseline oxygen saturation > 92% on room air\n    \n    \n\nKey ","\n\n 1.  History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (eg cervix, bladder, breast) unless disease free for at least 3 years\n 2.  Received more than one line of therapy for DLBCL\n 3.  History of autologous or allogeneic stem cell transplant\n 4.  Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring intravenous antimicrobials for management.\n 5.  Known history of infection with human immunodeficiency virus (HIV) or hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive). If there is a positive history of treated hepatitis B or hepatitis C, the viral load must be undetectable per quantitative polymerase chain reaction (PCR) and/or nucleic acid testing.\n 6.  Individuals with detectable cerebrospinal fluid malignant cells or known brain metastases, or with a history of cerebrospinal fluid malignant cells or brain metastases.\n 7.  History or presence of non-malignant central nervous system (CNS) disorder such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement\n 8.  Presence of any indwelling line or drain. Dedicated central venous access catheter such as a Port-a-Cath or Hickman catheter are permitted.\n 9.  History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, New York Heart Association Class II or greater congestive heart failure, or other clinically significant cardiac diseases within 12 months of enrollment\n 10. History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months of enrollment\n 11. History of autoimmune disease, requiring systemic immunosuppression and/or systemic disease modifying agents within the last 2 years\n 12. History of anti-CD19 or CAR-T therapy or history of prior randomization in ZUMA-7\n\nNote: Other protocol defined Inclusion/Exclusion criteria may apply",{"$nulls":4},"Actual","2018-01-05","Actual","Anticipated","2035-01-15","Anticipated","2018-12-01","2017-12-21","2017-12-29","2018-12-18","Yes",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No","Yes","Cheson BD, Fisher RI, Barrington SF, Cavalli F, Schwartz LH, Zucca E, Lister TA; Alliance, Australasian Leukaemia and Lymphoma Group; Eastern Cooperative Oncology Group; European Mantle Cell Lymphoma Consortium; Italian Lymphoma Foundation; European Organisation for Research; Treatment of Cancer/Dutch Hemato-Oncology Group; Grupo EspaÃ±ol de MÃ©dula Ã“sea; German High-Grade Lymphoma Study Group; German Hodgkin's Study Group; Japanese Lymphorra Study Group; Lymphoma Study Association; NCIC Clinical Trials Group; Nordic Lymphoma Study Group; Southwest Oncology Group; United Kingdom National Cancer Research Institute. Recommendations for initial evaluation, staging, and response assessment of Hodgkin and non-Hodgkin lymphoma: the Lugano classification. J Clin Oncol. 2014 Sep 20;32(27):3059-68. PubMed 25113753",null,null,"Yes","No",{"$nulls":17},"2017-002261-22","EudraCT Number","Event Free Survival","Event free survival is defined as the time from randomization to the earliest date of disease progression per Lugano Classification (Cheson et al, 2014), commencement of new lymphoma therapy, or death from any cause as determined by blinded central review","Up to 5 years","Objective Response Rate (ORR)|Overall Survival","Objective response rate is defined as the incidence of either a complete response or a partial response by the Lugano Classification (Cheson et al, 2014) as determined by blinded central review|Overall survival is defined as the time from randomization to death from any cause","Up to 5 years","medinfo@kitepharma.com","Medical Information","844-454-KITE","Brussels, BelgiumPrincipal Investigator: Xavier PoirÃ©, Md Uz Leuven GasthuisbertLeuven, BelgiumPrincipal Investigator: Peter Vandenberghe, Md, Phd|Vancouver, British Columbia, Canada|Winnipeg, Manitoba, Canada, R3E 0V9|Toronto, Ontario, Canada, M5G 2M9|Ottawa, Canada, K1H 8L6Principal Investigator: Natasha Kekre, Md|Paris, France, 75475Principal Investigator: Catherine Thieblmont, Md, Phd|Tel Aviv, Israel, 62431Principal Investigator: Irit Avivi, Md|Amsterdam, Netherlands, 1105 AzPrincipal Investigator: Marie JosÃ© Kersten, Md, Phd University Medical Center GroningenGroningen, Netherlands, 9700 RbPrincipal Investigator: Tom Van Meerten, Md, Phd Universitair Mendisch Centrum UtrechtUtrecht, NetherlandsPrincipal Investigator: Monique Minnema, Md, Phd|Barcelona, Spain, 08036Principal Investigator: Armando LÃ³pez-Guillermo, Md, Phd Institut Catala D'Oncologia De L'HospitaletBarcelona, Spain, 08908|Birmingham, United Kingdom, B15 2GwPrincipal Investigator: Sridhar Chaganti, Md The Christie Nhs Foundation TrustManchester, United Kingdom, M20 4BxPrincipal Investigator: John Radford, Md The Royal Marsden Nhs Foundation TrustSutton, United Kingdom, Sm2 5PtPrincipal Investigator: David Cunningham, Md|Gilbert, Arizona, United States, 85234|San Diego, California, United States, 92093-0698|Miami, Florida, United States, 33136|Chicago, Illinois, United States, 60612Principal Investigator: Reem Karmali, Md University Of ChicagoChicago, Illinois, United States, 60637|Iowa City, Iowa, United States, 52242|Kansas City, Kansas, United States, 66160|Baltimore, Maryland, United States, 21201|Boston, Massachusetts, United States, 02215|Detroit, Michigan, United States, 48201Principal Investigator: Abhinav Deol, Md|Rochester, Minnesota, United States, 55905|Saint Louis, Missouri, United States, 63130|Hackensack, New Jersey, United States, 07601|New York, New York, United States, 10029|Cleveland, Ohio, United States, 44195|Pittsburgh, Pennsylvania, United States, 15213|Nashville, Tennessee, United States, 37203|Houston, Texas, United States, 77030|Salt Lake City, Utah, United States, 84112Principal Investigator: Catherine Lee, Md|Charlottesville, Virginia, United States, 22908|Seattle, Washington, United States, 98104","Arizona|California|Florida|Illinois|Iowa|Kansas|Maryland|Massachusetts|Michigan|Minnesota|Missouri|New Jersey|New York|Ohio|Pennsylvania|Tennessee|Texas|Utah|Virginia|Washington","Belgium|Canada|France|Israel|Netherlands|Spain|United Kingdom|United States","Cliniques Universiaires Saint-Luc|British Columbia Vancouver General Hospital|Manitoba Cancercare Manitoba|Ontario Princess Margaret Hospital|The Ottawa Hospital - General Campus|Hopital Saint-Louis|Tel Aviv Souraski Medical Center|Academic Medical Center Amsterdam|Hospital Clinic De Barcelona|University Hospitals Birmingham Nhs Foundation Trust|Banner Md Anderson Cancer Center|Uc San Diego Moores Cancer Center|University Of Miami|Northwestern University|University Of Iowa|University Of Kansas Medical Center|University Of Maryland|Dana-Farber Cancer Institute|Karmanos Cancer Institute|Mayo Clinic|Washington University|Hackensack University Medical Center|Icahn School Of Medicine At Mount Sinai|Cleveland Clinic|University Of Pittsburgh Medical Center|Sarah Cannon Research Institute|Md Anderson Cancer Center|Huntsman Cancer Institute|University Of Virginia Health System|Swedish Cancer Institute",{"$nulls":3},"Kite Study Director","2018-12-18","2020-05-25T16:35:20.980","2020-05-26T17:10:42.972","NCT03391466"]
["5ecbf3c8feab101b155307de","NCT03391466","2019-01-09","Gilead Sciences","GILD","Recruiting","Efficacy of Axicabtagene Ciloleucel Compared to Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma (ZUMA-7)","Axicabtagene ciloleucel|Cyclophosphamide|Fludarabine|Autologous stem cell transplant","CAR-T|Immunomodulator|STAT1 Inhibitor|Autologous Cell Therapy","Yes","['Axicabtagene ciloleucel']","Yes","['CAR-T', 'Autologous Cell Therapy']","Phase 3",2,350,"Anticipated","2017-12-14","2022-01-15","EFS","Event Free Survival",{"$nulls":3},"The purpose of this study is to evaluate whether axicabtagene ciloleucel therapy improves the clinical outcome compared with standard of care second-line therapy in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL).","This is a phase 3 randomized, open-label, multicenter study evaluating the efficacy of axicabtagene ciloleucel versus standard of care therapy in subjects with relapsed/refractory DLBCL. Adult subjects with relapsed/refractory DLBCL after first-line rituximab and anthracycline-based chemotherapy will be randomized in a 1:1 ratio to receive axicabtagene ciloleucel or standard of care second-line therapy.\n\nStandard of care will consist of a protocol-defined, platinum-based salvage combination chemotherapy regimen followed by high-dose therapy and autologous stem cell transplant in those who respond to salvage chemotherapy.","A Phase 3, Randomized, Open-Label Study Evaluating Efficacy of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma","KTE-C19-107","Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)","Diffuse Large B-Cell Lymphoma|Lymphoma|Lymphoma, B-Cell","Oncology Hematological","Oncology","Experimental|Active Comparator","Axicabtagene Ciloleucel Treatment|Standard of Care Therapy",null,"Biological|Drug","Axicabtagene Ciloleucel|Cyclophosphamide|Fludarabine|Platinum-containing salvage chemotherapy (eg, R-ICE) followed by high dose therapy (eg, BEAM) and autologous stem cell transplant in responders.","A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells administered intravenously following a conditioning chemotherapy regimen of fludarabine and cyclophosphamide|Administered intravenously|Platinum-containing salvage chemotherapy (R-ICE, R-DHAP, R-ESHAP, or R-GDP as selected by treating investigator) followed by high dose therapy (eg, BEAM) and autologous stem cell transplant in responders.","KTE-C19 | axi-cel","Axicabtagene Ciloleucel Treatment|Standard of Care Therapy","\n\n 1. Histologically proven DLBCL, including transformation from follicular lymphoma\n 2. Relapsed or refractory disease after first-line chemoimmunotherapy * Refractory disease is defined as no complete remission to first-line therapy; individuals who are intolerant to first-line therapy are excluded. * Progressive disease (PD) as best response to first-line therapy\n        * Stable disease (SD) as best response after at least 4 cycles of first-line therapy\n        * Partial response (PR) as best response after at least 6 cycles and biopsy-proven residual disease or disease progression â‰¤ 12 months from initiation of therapy\n       \n       \n     * Relapsed disease defined as complete remission to first-line therapy followed by biopsy-proven relapse â‰¤ 12 months of initiating first-line therapy\n    \n    \n 3. Individuals must have received adequate first-line therapy including at a minimum: * Anti-CD20 monoclonal antibody unless investigator determines that tumor is CD20 negative, and\n     * An anthracycline containing chemotherapy regimen\n    \n    \n 4. No known history or suspicion of central nervous system involvement by lymphoma\n 5. Eastern cooperative oncology group (ECOG) performance status of 0 or 1\n 6. Adequate bone marrow function as evidenced by: * Absolute neutrophil count (ANC) â‰¥ 1000/uL\n     * Platelet â‰¥ 75,000/uL\n     * Absolute lymphocyte count â‰¥ 100/uL\n    \n    \n 7. Adequate renal, hepatic, cardiac, and pulmonary function as evidenced by: * Creatinine clearance (Cockcroft Gault) â‰¥ 60 mL/min\n     * Serum Alanine aminotransferase/Aspartate aminotransferase (ALT/AST) â‰¤ 2.5 Upper limit of normal (ULN)\n     * Total bilirubin â‰¤ 1.5 mg/dl\n     * Cardiac ejection fraction â‰¥ 50%, no evidence of pericardial effusion as determined by an Echocardiogram (ECHO), and no clinically significant Electrocardiogram (ECG) findings\n     * No clinically significant pleural effusion\n     * Baseline oxygen saturation > 92% on room air\n    \n    \n\nKey ","\n\n 1.  History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (eg cervix, bladder, breast) unless disease free for at least 3 years\n 2.  Received more than one line of therapy for DLBCL\n 3.  History of autologous or allogeneic stem cell transplant\n 4.  Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring intravenous antimicrobials for management.\n 5.  Known history of infection with human immunodeficiency virus (HIV) or hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive). If there is a positive history of treated hepatitis B or hepatitis C, the viral load must be undetectable per quantitative polymerase chain reaction (PCR) and/or nucleic acid testing.\n 6.  Individuals with detectable cerebrospinal fluid malignant cells or known brain metastases, or with a history of cerebrospinal fluid malignant cells or brain metastases.\n 7.  History or presence of non-malignant central nervous system (CNS) disorder such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement\n 8.  Presence of any indwelling line or drain. Dedicated central venous access catheter such as a Port-a-Cath or Hickman catheter are permitted.\n 9.  History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, New York Heart Association Class II or greater congestive heart failure, or other clinically significant cardiac diseases within 12 months of enrollment\n 10. History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months of enrollment\n 11. History of autoimmune disease, requiring systemic immunosuppression and/or systemic disease modifying agents within the last 2 years\n 12. History of anti-CD19 or CAR-T therapy or history of prior randomization in ZUMA-7\n\nNote: Other protocol defined Inclusion/Exclusion criteria may apply",{"$nulls":4},"Actual","2018-01-05","Actual","Anticipated","2035-01-15","Anticipated","2019-01-01","2017-12-21","2017-12-29","2019-01-07","Yes",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No","Yes","Cheson BD, Fisher RI, Barrington SF, Cavalli F, Schwartz LH, Zucca E, Lister TA; Alliance, Australasian Leukaemia and Lymphoma Group; Eastern Cooperative Oncology Group; European Mantle Cell Lymphoma Consortium; Italian Lymphoma Foundation; European Organisation for Research; Treatment of Cancer/Dutch Hemato-Oncology Group; Grupo EspaÃ±ol de MÃ©dula Ã“sea; German High-Grade Lymphoma Study Group; German Hodgkin's Study Group; Japanese Lymphorra Study Group; Lymphoma Study Association; NCIC Clinical Trials Group; Nordic Lymphoma Study Group; Southwest Oncology Group; United Kingdom National Cancer Research Institute. Recommendations for initial evaluation, staging, and response assessment of Hodgkin and non-Hodgkin lymphoma: the Lugano classification. J Clin Oncol. 2014 Sep 20;32(27):3059-68. PubMed 25113753",null,null,"Yes","No",{"$nulls":17},"2017-002261-22","EudraCT Number","Event Free Survival","Event free survival is defined as the time from randomization to the earliest date of disease progression per Lugano Classification (Cheson et al, 2014), commencement of new lymphoma therapy, or death from any cause as determined by blinded central review","Up to 5 years","Objective Response Rate (ORR)|Overall Survival","Objective response rate is defined as the incidence of either a complete response or a partial response by the Lugano Classification (Cheson et al, 2014) as determined by blinded central review|Overall survival is defined as the time from randomization to death from any cause","Up to 5 years","medinfo@kitepharma.com","Medical Information","844-454-KITE","Brussels, BelgiumPrincipal Investigator: Xavier PoirÃ©, Md Uz Leuven GasthuisbertLeuven, BelgiumPrincipal Investigator: Peter Vandenberghe, Md, Phd|Vancouver, British Columbia, Canada|Winnipeg, Manitoba, Canada, R3E 0V9|Toronto, Ontario, Canada, M5G 2M9|Ottawa, Canada, K1H 8L6Principal Investigator: Natasha Kekre, Md|Paris, France, 75475Principal Investigator: Catherine Thieblmont, Md, Phd|Dresden, Germany, 01307Principal Investigator: Martin Wermke, Md UniversitÃ¤ts-Klinikum WÃ¼rzburgWÃ¼rzburg, Germany, 97080Principal Investigator: Max Topp, Md|Tel Aviv, Israel, 62431Principal Investigator: Irit Avivi, Md|Amsterdam, Netherlands, 1105 AzPrincipal Investigator: Marie JosÃ© Kersten, Md, Phd University Medical Center GroningenGroningen, Netherlands, 9700 RbPrincipal Investigator: Tom Van Meerten, Md, Phd Universitair Mendisch Centrum UtrechtUtrecht, NetherlandsPrincipal Investigator: Monique Minnema, Md, Phd|Barcelona, Spain, 08036Principal Investigator: Armando LÃ³pez-Guillermo, Md, Phd Institut Catala D'Oncologia De L'HospitaletBarcelona, Spain, 08908|Birmingham, United Kingdom, B15 2GwPrincipal Investigator: Sridhar Chaganti, Md The Christie Nhs Foundation TrustManchester, United Kingdom, M20 4BxPrincipal Investigator: John Radford, Md The Royal Marsden Nhs Foundation TrustSutton, United Kingdom, Sm2 5PtPrincipal Investigator: David Cunningham, Md|Gilbert, Arizona, United States, 85234|San Diego, California, United States, 92093-0698|Miami, Florida, United States, 33136|Chicago, Illinois, United States, 60612Principal Investigator: Reem Karmali, Md University Of ChicagoChicago, Illinois, United States, 60637|Iowa City, Iowa, United States, 52242|Kansas City, Kansas, United States, 66160|Baltimore, Maryland, United States, 21201|Boston, Massachusetts, United States, 02215|Detroit, Michigan, United States, 48201Principal Investigator: Abhinav Deol, Md|Rochester, Minnesota, United States, 55905|Saint Louis, Missouri, United States, 63130|Hackensack, New Jersey, United States, 07601|New York, New York, United States, 10029|Cleveland, Ohio, United States, 44195|Pittsburgh, Pennsylvania, United States, 15213|Nashville, Tennessee, United States, 37203|Houston, Texas, United States, 77030|Salt Lake City, Utah, United States, 84112Principal Investigator: Catherine Lee, Md|Charlottesville, Virginia, United States, 22908|Seattle, Washington, United States, 98104","Arizona|California|Florida|Illinois|Iowa|Kansas|Maryland|Massachusetts|Michigan|Minnesota|Missouri|New Jersey|New York|Ohio|Pennsylvania|Tennessee|Texas|Utah|Virginia|Washington","Belgium|Canada|France|Germany|Israel|Netherlands|Spain|United Kingdom|United States","Cliniques Universiaires Saint-Luc|British Columbia Vancouver General Hospital|Manitoba Cancercare Manitoba|Ontario Princess Margaret Hospital|The Ottawa Hospital - General Campus|Hopital Saint-Louis|UniversitÃ¤ts-Klinikum Dresden|Tel Aviv Souraski Medical Center|Academic Medical Center Amsterdam|Hospital Clinic De Barcelona|University Hospitals Birmingham Nhs Foundation Trust|Banner Md Anderson Cancer Center|Uc San Diego Moores Cancer Center|University Of Miami|Northwestern University|University Of Iowa|University Of Kansas Medical Center|University Of Maryland|Dana-Farber Cancer Institute|Karmanos Cancer Institute|Mayo Clinic|Washington University|Hackensack University Medical Center|Icahn School Of Medicine At Mount Sinai|Cleveland Clinic|University Of Pittsburgh Medical Center|Sarah Cannon Research Institute|Md Anderson Cancer Center|Huntsman Cancer Institute|University Of Virginia Health System|Swedish Cancer Institute",{"$nulls":3},"Kite Study Director","2019-01-07","2020-05-25T16:35:20.627","2020-05-26T17:10:42.972","NCT03391466"]
["5ecbf3c8e2561b1b11905caa","NCT03391466","2019-01-29","Gilead Sciences","GILD","Recruiting","Efficacy of Axicabtagene Ciloleucel Compared to Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma (ZUMA-7)","Axicabtagene ciloleucel|Cyclophosphamide|Fludarabine|Autologous stem cell transplant","CAR-T|Immunomodulator|STAT1 Inhibitor|Autologous Cell Therapy","Yes","['Axicabtagene ciloleucel']","Yes","['CAR-T', 'Autologous Cell Therapy']","Phase 3",2,350,"Anticipated","2017-12-14","2022-01-15","EFS","Event Free Survival",{"$nulls":3},"The purpose of this study is to evaluate whether axicabtagene ciloleucel therapy improves the clinical outcome compared with standard of care second-line therapy in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL).","This is a phase 3 randomized, open-label, multicenter study evaluating the efficacy of axicabtagene ciloleucel versus standard of care therapy in subjects with relapsed/refractory DLBCL. Adult subjects with relapsed/refractory DLBCL after first-line rituximab and anthracycline-based chemotherapy will be randomized in a 1:1 ratio to receive axicabtagene ciloleucel or standard of care second-line therapy.\n\nStandard of care will consist of a protocol-defined, platinum-based salvage combination chemotherapy regimen followed by high-dose therapy and autologous stem cell transplant in those who respond to salvage chemotherapy.","A Phase 3, Randomized, Open-Label Study Evaluating Efficacy of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma","KTE-C19-107","Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)","Diffuse Large B-Cell Lymphoma|Lymphoma|Lymphoma, B-Cell","Oncology Hematological","Oncology","Experimental|Active Comparator","Axicabtagene Ciloleucel Treatment|Standard of Care Therapy",null,"Biological|Drug","Axicabtagene Ciloleucel|Cyclophosphamide|Fludarabine|Platinum-containing salvage chemotherapy (eg, R-ICE) followed by high dose therapy (eg, BEAM) and autologous stem cell transplant in responders.","A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells administered intravenously following a conditioning chemotherapy regimen of fludarabine and cyclophosphamide|Administered intravenously|Platinum-containing salvage chemotherapy (R-ICE, R-DHAP, R-ESHAP, or R-GDP as selected by treating investigator) followed by high dose therapy (eg, BEAM) and autologous stem cell transplant in responders.","KTE-C19 | axi-cel","Axicabtagene Ciloleucel Treatment|Standard of Care Therapy","\n\n 1. Histologically proven DLBCL, including transformation from follicular lymphoma\n 2. Relapsed or refractory disease after first-line chemoimmunotherapy * Refractory disease is defined as no complete remission to first-line therapy; individuals who are intolerant to first-line therapy are excluded. * Progressive disease (PD) as best response to first-line therapy\n        * Stable disease (SD) as best response after at least 4 cycles of first-line therapy\n        * Partial response (PR) as best response after at least 6 cycles and biopsy-proven residual disease or disease progression â‰¤ 12 months from initiation of therapy\n       \n       \n     * Relapsed disease defined as complete remission to first-line therapy followed by biopsy-proven relapse â‰¤ 12 months of initiating first-line therapy\n    \n    \n 3. Individuals must have received adequate first-line therapy including at a minimum: * Anti-CD20 monoclonal antibody unless investigator determines that tumor is CD20 negative, and\n     * An anthracycline containing chemotherapy regimen\n    \n    \n 4. No known history or suspicion of central nervous system involvement by lymphoma\n 5. Eastern cooperative oncology group (ECOG) performance status of 0 or 1\n 6. Adequate bone marrow function as evidenced by: * Absolute neutrophil count (ANC) â‰¥ 1000/uL\n     * Platelet â‰¥ 75,000/uL\n     * Absolute lymphocyte count â‰¥ 100/uL\n    \n    \n 7. Adequate renal, hepatic, cardiac, and pulmonary function as evidenced by: * Creatinine clearance (Cockcroft Gault) â‰¥ 60 mL/min\n     * Serum Alanine aminotransferase/Aspartate aminotransferase (ALT/AST) â‰¤ 2.5 Upper limit of normal (ULN)\n     * Total bilirubin â‰¤ 1.5 mg/dl\n     * Cardiac ejection fraction â‰¥ 50%, no evidence of pericardial effusion as determined by an Echocardiogram (ECHO), and no clinically significant Electrocardiogram (ECG) findings\n     * No clinically significant pleural effusion\n     * Baseline oxygen saturation > 92% on room air\n    \n    \n\nKey ","\n\n 1.  History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (eg cervix, bladder, breast) unless disease free for at least 3 years\n 2.  Received more than one line of therapy for DLBCL\n 3.  History of autologous or allogeneic stem cell transplant\n 4.  Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring intravenous antimicrobials for management.\n 5.  Known history of infection with human immunodeficiency virus (HIV) or hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive). If there is a positive history of treated hepatitis B or hepatitis C, the viral load must be undetectable per quantitative polymerase chain reaction (PCR) and/or nucleic acid testing.\n 6.  Individuals with detectable cerebrospinal fluid malignant cells or known brain metastases, or with a history of cerebrospinal fluid malignant cells or brain metastases.\n 7.  History or presence of non-malignant central nervous system (CNS) disorder such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement\n 8.  Presence of any indwelling line or drain. Dedicated central venous access catheter such as a Port-a-Cath or Hickman catheter are permitted.\n 9.  History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, New York Heart Association Class II or greater congestive heart failure, or other clinically significant cardiac diseases within 12 months of enrollment\n 10. History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months of enrollment\n 11. History of autoimmune disease, requiring systemic immunosuppression and/or systemic disease modifying agents within the last 2 years\n 12. History of anti-CD19 or CAR-T therapy or history of prior randomization in ZUMA-7\n\nNote: Other protocol defined Inclusion/Exclusion criteria may apply",{"$nulls":4},"Actual","2018-01-05","Actual","Anticipated","2035-01-15","Anticipated","2019-01-01","2017-12-21","2017-12-29","2019-01-25","Yes",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No","Yes","Cheson BD, Fisher RI, Barrington SF, Cavalli F, Schwartz LH, Zucca E, Lister TA; Alliance, Australasian Leukaemia and Lymphoma Group; Eastern Cooperative Oncology Group; European Mantle Cell Lymphoma Consortium; Italian Lymphoma Foundation; European Organisation for Research; Treatment of Cancer/Dutch Hemato-Oncology Group; Grupo EspaÃ±ol de MÃ©dula Ã“sea; German High-Grade Lymphoma Study Group; German Hodgkin's Study Group; Japanese Lymphorra Study Group; Lymphoma Study Association; NCIC Clinical Trials Group; Nordic Lymphoma Study Group; Southwest Oncology Group; United Kingdom National Cancer Research Institute. Recommendations for initial evaluation, staging, and response assessment of Hodgkin and non-Hodgkin lymphoma: the Lugano classification. J Clin Oncol. 2014 Sep 20;32(27):3059-68. PubMed 25113753",null,null,"Yes","No",{"$nulls":17},"2017-002261-22","EudraCT Number","Event Free Survival","Event free survival is defined as the time from randomization to the earliest date of disease progression per Lugano Classification (Cheson et al, 2014), commencement of new lymphoma therapy, or death from any cause as determined by blinded central review","Up to 5 years","Objective Response Rate (ORR)|Overall Survival","Objective response rate is defined as the incidence of either a complete response or a partial response by the Lugano Classification (Cheson et al, 2014) as determined by blinded central review|Overall survival is defined as the time from randomization to death from any cause","Up to 5 years","medinfo@kitepharma.com","Medical Information","844-454-KITE","Brussels, BelgiumPrincipal Investigator: Xavier PoirÃ©, Md Uz Leuven GasthuisbertLeuven, BelgiumPrincipal Investigator: Peter Vandenberghe, Md, Phd|Vancouver, British Columbia, Canada|Winnipeg, Manitoba, Canada, R3E 0V9|Toronto, Ontario, Canada, M5G 2M9|Halifax, Canada, B3H 2Y9|Paris, France, 75475Principal Investigator: Catherine Thieblmont, Md, Phd|Dresden, Germany, 01307Principal Investigator: Martin Wermke, Md UniversitÃ¤ts-Klinikum WÃ¼rzburgWÃ¼rzburg, Germany, 97080Principal Investigator: Max Topp, Md|Tel Aviv, Israel, 62431Principal Investigator: Irit Avivi, Md|Amsterdam, Netherlands, 1105 AzPrincipal Investigator: Marie JosÃ© Kersten, Md, Phd University Medical Center GroningenGroningen, Netherlands, 9700 RbPrincipal Investigator: Tom Van Meerten, Md, Phd Universitair Mendisch Centrum UtrechtUtrecht, NetherlandsPrincipal Investigator: Monique Minnema, Md, Phd|Barcelona, Spain, 08036Principal Investigator: Armando LÃ³pez-Guillermo, Md, Phd Institut Catala D'Oncologia De L'HospitaletBarcelona, Spain, 08908|Birmingham, United Kingdom, B15 2GwPrincipal Investigator: Sridhar Chaganti, Md The Christie Nhs Foundation TrustManchester, United Kingdom, M20 4BxPrincipal Investigator: John Radford, Md The Royal Marsden Nhs Foundation TrustSutton, United Kingdom, Sm2 5PtPrincipal Investigator: David Cunningham, Md|Gilbert, Arizona, United States, 85234|San Diego, California, United States, 92093-0698|Miami, Florida, United States, 33136|Chicago, Illinois, United States, 60612Principal Investigator: Reem Karmali, Md University Of ChicagoChicago, Illinois, United States, 60637|Iowa City, Iowa, United States, 52242|Kansas City, Kansas, United States, 66160|Baltimore, Maryland, United States, 21201|Boston, Massachusetts, United States, 02215|Detroit, Michigan, United States, 48201Principal Investigator: Abhinav Deol, Md|Rochester, Minnesota, United States, 55905|Saint Louis, Missouri, United States, 63130|Hackensack, New Jersey, United States, 07601|New York, New York, United States, 10029|Cleveland, Ohio, United States, 44195|Pittsburgh, Pennsylvania, United States, 15213|Nashville, Tennessee, United States, 37203|Houston, Texas, United States, 77030|Salt Lake City, Utah, United States, 84112Principal Investigator: Catherine Lee, Md|Charlottesville, Virginia, United States, 22908|Seattle, Washington, United States, 98104","Arizona|California|Florida|Illinois|Iowa|Kansas|Maryland|Massachusetts|Michigan|Minnesota|Missouri|New Jersey|New York|Ohio|Pennsylvania|Tennessee|Texas|Utah|Virginia|Washington","Belgium|Canada|France|Germany|Israel|Netherlands|Spain|United Kingdom|United States","Cliniques Universiaires Saint-Luc|British Columbia Vancouver General Hospital|Manitoba Cancercare Manitoba|Ontario Princess Margaret Hospital|Qeii Health Sciences Centre|Hopital Saint-Louis|UniversitÃ¤ts-Klinikum Dresden|Tel Aviv Souraski Medical Center|Academic Medical Center Amsterdam|Hospital Clinic De Barcelona|University Hospitals Birmingham Nhs Foundation Trust|Banner Md Anderson Cancer Center|Uc San Diego Moores Cancer Center|University Of Miami|Northwestern University|University Of Iowa|University Of Kansas Medical Center|University Of Maryland|Dana-Farber Cancer Institute|Karmanos Cancer Institute|Mayo Clinic|Washington University|Hackensack University Medical Center|Icahn School Of Medicine At Mount Sinai|Cleveland Clinic|University Of Pittsburgh Medical Center|Sarah Cannon Research Institute|Md Anderson Cancer Center|Huntsman Cancer Institute|University Of Virginia Health System|Swedish Cancer Institute",{"$nulls":3},"Kite Study Director","2019-01-25","2020-05-25T16:35:20.819","2020-05-26T17:10:42.972","NCT03391466"]
["5ecbf3c8307e3d1b1f8d9c3e","NCT03391466","2019-02-18","Gilead Sciences","GILD","Recruiting","Efficacy of Axicabtagene Ciloleucel Compared to Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma (ZUMA-7)","Axicabtagene ciloleucel|Cyclophosphamide|Fludarabine|Autologous stem cell transplant","CAR-T|Immunomodulator|STAT1 Inhibitor|Autologous Cell Therapy","Yes","['Axicabtagene ciloleucel']","Yes","['CAR-T', 'Autologous Cell Therapy']","Phase 3",2,350,"Anticipated","2017-12-14","2022-01-15","EFS","Event Free Survival",{"$nulls":3},"The purpose of this study is to evaluate whether axicabtagene ciloleucel therapy improves the clinical outcome compared with standard of care second-line therapy in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL).","This is a phase 3 randomized, open-label, multicenter study evaluating the efficacy of axicabtagene ciloleucel versus standard of care therapy in subjects with relapsed/refractory DLBCL. Adult subjects with relapsed/refractory DLBCL after first-line rituximab and anthracycline-based chemotherapy will be randomized in a 1:1 ratio to receive axicabtagene ciloleucel or standard of care second-line therapy.\n\nStandard of care will consist of a protocol-defined, platinum-based salvage combination chemotherapy regimen followed by high-dose therapy and autologous stem cell transplant in those who respond to salvage chemotherapy.","A Phase 3, Randomized, Open-Label Study Evaluating Efficacy of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma","KTE-C19-107","Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)","Diffuse Large B-Cell Lymphoma|Lymphoma|Lymphoma, B-Cell","Oncology Hematological","Oncology","Experimental|Active Comparator","Axicabtagene Ciloleucel Treatment|Standard of Care Therapy",null,"Biological|Drug","Axicabtagene Ciloleucel|Cyclophosphamide|Fludarabine|Platinum-containing salvage chemotherapy (eg, R-ICE) followed by high dose therapy (eg, BEAM) and autologous stem cell transplant in responders.","A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells administered intravenously following a conditioning chemotherapy regimen of fludarabine and cyclophosphamide|Administered intravenously|Platinum-containing salvage chemotherapy (R-ICE, R-DHAP, R-ESHAP, or R-GDP as selected by treating investigator) followed by high dose therapy (eg, BEAM) and autologous stem cell transplant in responders.","KTE-C19 | axi-cel","Axicabtagene Ciloleucel Treatment|Standard of Care Therapy","\n\n 1. Histologically proven DLBCL, including transformation from follicular lymphoma\n 2. Relapsed or refractory disease after first-line chemoimmunotherapy * Refractory disease is defined as no complete remission to first-line therapy; individuals who are intolerant to first-line therapy are excluded. * Progressive disease (PD) as best response to first-line therapy\n        * Stable disease (SD) as best response after at least 4 cycles of first-line therapy\n        * Partial response (PR) as best response after at least 6 cycles and biopsy-proven residual disease or disease progression â‰¤ 12 months from initiation of therapy\n       \n       \n     * Relapsed disease defined as complete remission to first-line therapy followed by biopsy-proven relapse â‰¤ 12 months of initiating first-line therapy\n    \n    \n 3. Individuals must have received adequate first-line therapy including at a minimum: * Anti-CD20 monoclonal antibody unless investigator determines that tumor is CD20 negative, and\n     * An anthracycline containing chemotherapy regimen\n    \n    \n 4. No known history or suspicion of central nervous system involvement by lymphoma\n 5. Eastern cooperative oncology group (ECOG) performance status of 0 or 1\n 6. Adequate bone marrow function as evidenced by: * Absolute neutrophil count (ANC) â‰¥ 1000/uL\n     * Platelet â‰¥ 75,000/uL\n     * Absolute lymphocyte count â‰¥ 100/uL\n    \n    \n 7. Adequate renal, hepatic, cardiac, and pulmonary function as evidenced by: * Creatinine clearance (Cockcroft Gault) â‰¥ 60 mL/min\n     * Serum Alanine aminotransferase/Aspartate aminotransferase (ALT/AST) â‰¤ 2.5 Upper limit of normal (ULN)\n     * Total bilirubin â‰¤ 1.5 mg/dl\n     * Cardiac ejection fraction â‰¥ 50%, no evidence of pericardial effusion as determined by an Echocardiogram (ECHO), and no clinically significant Electrocardiogram (ECG) findings\n     * No clinically significant pleural effusion\n     * Baseline oxygen saturation > 92% on room air\n    \n    \n\nKey ","\n\n 1.  History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (eg cervix, bladder, breast) unless disease free for at least 3 years\n 2.  Received more than one line of therapy for DLBCL\n 3.  History of autologous or allogeneic stem cell transplant\n 4.  Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring intravenous antimicrobials for management.\n 5.  Known history of infection with human immunodeficiency virus (HIV) or hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive). If there is a positive history of treated hepatitis B or hepatitis C, the viral load must be undetectable per quantitative polymerase chain reaction (PCR) and/or nucleic acid testing.\n 6.  Individuals with detectable cerebrospinal fluid malignant cells or known brain metastases, or with a history of cerebrospinal fluid malignant cells or brain metastases.\n 7.  History or presence of non-malignant central nervous system (CNS) disorder such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement\n 8.  Presence of any indwelling line or drain. Dedicated central venous access catheter such as a Port-a-Cath or Hickman catheter are permitted.\n 9.  History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, New York Heart Association Class II or greater congestive heart failure, or other clinically significant cardiac diseases within 12 months of enrollment\n 10. History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months of enrollment\n 11. History of autoimmune disease, requiring systemic immunosuppression and/or systemic disease modifying agents within the last 2 years\n 12. History of anti-CD19 or CAR-T therapy or history of prior randomization in ZUMA-7\n\nNote: Other protocol defined Inclusion/Exclusion criteria may apply",{"$nulls":4},"Actual","2018-01-05","Actual","Anticipated","2035-01-15","Anticipated","2019-02-01","2017-12-21","2017-12-29","2019-02-14","Yes",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No","Yes","Cheson BD, Fisher RI, Barrington SF, Cavalli F, Schwartz LH, Zucca E, Lister TA; Alliance, Australasian Leukaemia and Lymphoma Group; Eastern Cooperative Oncology Group; European Mantle Cell Lymphoma Consortium; Italian Lymphoma Foundation; European Organisation for Research; Treatment of Cancer/Dutch Hemato-Oncology Group; Grupo EspaÃ±ol de MÃ©dula Ã“sea; German High-Grade Lymphoma Study Group; German Hodgkin's Study Group; Japanese Lymphorra Study Group; Lymphoma Study Association; NCIC Clinical Trials Group; Nordic Lymphoma Study Group; Southwest Oncology Group; United Kingdom National Cancer Research Institute. Recommendations for initial evaluation, staging, and response assessment of Hodgkin and non-Hodgkin lymphoma: the Lugano classification. J Clin Oncol. 2014 Sep 20;32(27):3059-68. PubMed 25113753",null,null,"Yes","No",{"$nulls":17},"2017-002261-22","EudraCT Number","Event Free Survival","Event free survival is defined as the time from randomization to the earliest date of disease progression per Lugano Classification (Cheson et al, 2014), commencement of new lymphoma therapy, or death from any cause as determined by blinded central review","Up to 5 years","Objective Response Rate (ORR)|Overall Survival","Objective response rate is defined as the incidence of either a complete response or a partial response by the Lugano Classification (Cheson et al, 2014) as determined by blinded central review|Overall survival is defined as the time from randomization to death from any cause","Up to 5 years","medinfo@kitepharma.com","Medical Information","1-844-454-5483(1-844-454-KITE)","Brussels, BelgiumPrincipal Investigator: Xavier PoirÃ©, Md Uz Leuven GasthuisbertLeuven, BelgiumPrincipal Investigator: Peter Vandenberghe, Md, Phd|Vancouver, British Columbia, Canada|Winnipeg, Manitoba, Canada, R3E 0V9|Toronto, Ontario, Canada, M5G 2M9|Halifax, Canada, B3H 2Y9|Paris, France, 75475Principal Investigator: Catherine Thieblmont, Md, Phd|Dresden, Germany, 01307Principal Investigator: Martin Wermke, Md UniversitÃ¤ts-Klinikum WÃ¼rzburgWÃ¼rzburg, Germany, 97080Principal Investigator: Max Topp, Md|Tel Aviv, Israel, 62431Principal Investigator: Irit Avivi, Md|Amsterdam, Netherlands, 1105 AzPrincipal Investigator: Marie JosÃ© Kersten, Md, Phd University Medical Center GroningenGroningen, Netherlands, 9700 RbPrincipal Investigator: Tom Van Meerten, Md, Phd Universitair Mendisch Centrum UtrechtUtrecht, NetherlandsPrincipal Investigator: Monique Minnema, Md, Phd|Barcelona, Spain, 08036Principal Investigator: Armando LÃ³pez-Guillermo, Md, Phd Institut Catala D'Oncologia De L'HospitaletBarcelona, Spain, 08908|Birmingham, United Kingdom, B15 2GwPrincipal Investigator: Sridhar Chaganti, Md The Christie Nhs Foundation TrustManchester, United Kingdom, M20 4BxPrincipal Investigator: John Radford, Md The Royal Marsden Nhs Foundation TrustSutton, United Kingdom, Sm2 5PtPrincipal Investigator: David Cunningham, Md|Gilbert, Arizona, United States, 85234|San Diego, California, United States, 92093-0698|Miami, Florida, United States, 33136|Chicago, Illinois, United States, 60612Principal Investigator: Reem Karmali, Md University Of ChicagoChicago, Illinois, United States, 60637|Iowa City, Iowa, United States, 52242|Kansas City, Kansas, United States, 66160|Baltimore, Maryland, United States, 21201|Boston, Massachusetts, United States, 02215|Detroit, Michigan, United States, 48201Principal Investigator: Abhinav Deol, Md|Rochester, Minnesota, United States, 55905|Saint Louis, Missouri, United States, 63130|Hackensack, New Jersey, United States, 07601|New York, New York, United States, 10029|Cleveland, Ohio, United States, 44195|Pittsburgh, Pennsylvania, United States, 15213|Nashville, Tennessee, United States, 37203|Houston, Texas, United States, 77030|Salt Lake City, Utah, United States, 84112Principal Investigator: Catherine Lee, Md|Charlottesville, Virginia, United States, 22908|Seattle, Washington, United States, 98104","Arizona|California|Florida|Illinois|Iowa|Kansas|Maryland|Massachusetts|Michigan|Minnesota|Missouri|New Jersey|New York|Ohio|Pennsylvania|Tennessee|Texas|Utah|Virginia|Washington","Belgium|Canada|France|Germany|Israel|Netherlands|Spain|United Kingdom|United States","Cliniques Universiaires Saint-Luc|British Columbia Vancouver General Hospital|Manitoba Cancercare Manitoba|Ontario Princess Margaret Hospital|Qeii Health Sciences Centre|Hopital Saint-Louis|UniversitÃ¤ts-Klinikum Dresden|Tel Aviv Souraski Medical Center|Academic Medical Center Amsterdam|Hospital Clinic De Barcelona|University Hospitals Birmingham Nhs Foundation Trust|Banner Md Anderson Cancer Center|Uc San Diego Moores Cancer Center|University Of Miami|Northwestern University|University Of Iowa|University Of Kansas Medical Center|University Of Maryland|Dana-Farber Cancer Institute|Karmanos Cancer Institute|Mayo Clinic|Washington University|Hackensack University Medical Center|Icahn School Of Medicine At Mount Sinai|Cleveland Clinic|University Of Pittsburgh Medical Center|Sarah Cannon Research Institute|Md Anderson Cancer Center|Huntsman Cancer Institute|University Of Virginia Health System|Swedish Cancer Institute",{"$nulls":3},"Kite Study Director","2019-02-14","2020-05-25T16:35:20.429","2020-05-26T17:10:42.972","NCT03391466"]
["5ecbf3c811702c1b1b9169c2","NCT03391466","2019-03-08","Gilead Sciences","GILD","Recruiting","Efficacy of Axicabtagene Ciloleucel Compared to Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma (ZUMA-7)","Axicabtagene ciloleucel|Cyclophosphamide|Fludarabine|Autologous stem cell transplant","CAR-T|Immunomodulator|STAT1 Inhibitor|Autologous Cell Therapy","Yes","['Axicabtagene ciloleucel']","Yes","['CAR-T', 'Autologous Cell Therapy']","Phase 3",2,350,"Anticipated","2017-12-14","2022-01-15","EFS","Event Free Survival",{"$nulls":3},"The purpose of this study is to evaluate whether axicabtagene ciloleucel therapy improves the clinical outcome compared with standard of care second-line therapy in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL).","This is a phase 3 randomized, open-label, multicenter study evaluating the efficacy of axicabtagene ciloleucel versus standard of care therapy in subjects with relapsed/refractory DLBCL. Adult subjects with relapsed/refractory DLBCL after first-line rituximab and anthracycline-based chemotherapy will be randomized in a 1:1 ratio to receive axicabtagene ciloleucel or standard of care second-line therapy.\n\nStandard of care will consist of a protocol-defined, platinum-based salvage combination chemotherapy regimen followed by high-dose therapy and autologous stem cell transplant in those who respond to salvage chemotherapy.","A Phase 3, Randomized, Open-Label Study Evaluating Efficacy of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma","KTE-C19-107","Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)","Diffuse Large B-Cell Lymphoma|Lymphoma|Lymphoma, B-Cell","Oncology Hematological","Oncology","Experimental|Active Comparator","Axicabtagene Ciloleucel Treatment|Standard of Care Therapy",null,"Biological|Drug","Axicabtagene Ciloleucel|Cyclophosphamide|Fludarabine|Platinum-containing salvage chemotherapy (eg, R-ICE) followed by high dose therapy (eg, BEAM) and autologous stem cell transplant in responders.","A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells administered intravenously following a conditioning chemotherapy regimen of fludarabine and cyclophosphamide|Administered intravenously|Platinum-containing salvage chemotherapy (R-ICE, R-DHAP, R-ESHAP, or R-GDP as selected by treating investigator) followed by high dose therapy (eg, BEAM) and autologous stem cell transplant in responders.","KTE-C19 | axi-cel","Axicabtagene Ciloleucel Treatment|Standard of Care Therapy","\n\n 1. Histologically proven DLBCL, including transformation from follicular lymphoma\n 2. Relapsed or refractory disease after first-line chemoimmunotherapy * Refractory disease is defined as no complete remission to first-line therapy; individuals who are intolerant to first-line therapy are excluded. * Progressive disease (PD) as best response to first-line therapy\n        * Stable disease (SD) as best response after at least 4 cycles of first-line therapy\n        * Partial response (PR) as best response after at least 6 cycles and biopsy-proven residual disease or disease progression â‰¤ 12 months from initiation of therapy\n       \n       \n     * Relapsed disease defined as complete remission to first-line therapy followed by biopsy-proven relapse â‰¤ 12 months of initiating first-line therapy\n    \n    \n 3. Individuals must have received adequate first-line therapy including at a minimum: * Anti-CD20 monoclonal antibody unless investigator determines that tumor is CD20 negative, and\n     * An anthracycline containing chemotherapy regimen\n    \n    \n 4. No known history or suspicion of central nervous system involvement by lymphoma\n 5. Eastern cooperative oncology group (ECOG) performance status of 0 or 1\n 6. Adequate bone marrow function as evidenced by: * Absolute neutrophil count (ANC) â‰¥ 1000/uL\n     * Platelet â‰¥ 75,000/uL\n     * Absolute lymphocyte count â‰¥ 100/uL\n    \n    \n 7. Adequate renal, hepatic, cardiac, and pulmonary function as evidenced by: * Creatinine clearance (Cockcroft Gault) â‰¥ 60 mL/min\n     * Serum Alanine aminotransferase/Aspartate aminotransferase (ALT/AST) â‰¤ 2.5 Upper limit of normal (ULN)\n     * Total bilirubin â‰¤ 1.5 mg/dl\n     * Cardiac ejection fraction â‰¥ 50%, no evidence of pericardial effusion as determined by an Echocardiogram (ECHO), and no clinically significant Electrocardiogram (ECG) findings\n     * No clinically significant pleural effusion\n     * Baseline oxygen saturation > 92% on room air\n    \n    \n\nKey ","\n\n 1.  History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (eg cervix, bladder, breast) unless disease free for at least 3 years\n 2.  Received more than one line of therapy for DLBCL\n 3.  History of autologous or allogeneic stem cell transplant\n 4.  Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring intravenous antimicrobials for management.\n 5.  Known history of infection with human immunodeficiency virus (HIV) or hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive). If there is a positive history of treated hepatitis B or hepatitis C, the viral load must be undetectable per quantitative polymerase chain reaction (PCR) and/or nucleic acid testing.\n 6.  Individuals with detectable cerebrospinal fluid malignant cells or known brain metastases, or with a history of cerebrospinal fluid malignant cells or brain metastases.\n 7.  History or presence of non-malignant central nervous system (CNS) disorder such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement\n 8.  Presence of any indwelling line or drain. Dedicated central venous access catheter such as a Port-a-Cath or Hickman catheter are permitted.\n 9.  History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, New York Heart Association Class II or greater congestive heart failure, or other clinically significant cardiac diseases within 12 months of enrollment\n 10. History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months of enrollment\n 11. History of autoimmune disease, requiring systemic immunosuppression and/or systemic disease modifying agents within the last 2 years\n 12. History of anti-CD19 or CAR-T therapy or history of prior randomization in ZUMA-7\n\nNote: Other protocol defined Inclusion/Exclusion criteria may apply",{"$nulls":4},"Actual","2018-01-05","Actual","Anticipated","2035-01-15","Anticipated","2019-03-01","2017-12-21","2017-12-29","2019-03-06","Yes",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No","Yes","Cheson BD, Fisher RI, Barrington SF, Cavalli F, Schwartz LH, Zucca E, Lister TA; Alliance, Australasian Leukaemia and Lymphoma Group; Eastern Cooperative Oncology Group; European Mantle Cell Lymphoma Consortium; Italian Lymphoma Foundation; European Organisation for Research; Treatment of Cancer/Dutch Hemato-Oncology Group; Grupo EspaÃ±ol de MÃ©dula Ã“sea; German High-Grade Lymphoma Study Group; German Hodgkin's Study Group; Japanese Lymphorra Study Group; Lymphoma Study Association; NCIC Clinical Trials Group; Nordic Lymphoma Study Group; Southwest Oncology Group; United Kingdom National Cancer Research Institute. Recommendations for initial evaluation, staging, and response assessment of Hodgkin and non-Hodgkin lymphoma: the Lugano classification. J Clin Oncol. 2014 Sep 20;32(27):3059-68. PubMed 25113753",null,null,"Yes","No",{"$nulls":17},"2017-002261-22","EudraCT Number","Event Free Survival","Event free survival is defined as the time from randomization to the earliest date of disease progression per Lugano Classification (Cheson et al, 2014), commencement of new lymphoma therapy, or death from any cause as determined by blinded central review","Up to 5 years","Objective Response Rate (ORR)|Overall Survival","Objective response rate is defined as the incidence of either a complete response or a partial response by the Lugano Classification (Cheson et al, 2014) as determined by blinded central review|Overall survival is defined as the time from randomization to death from any cause","Up to 5 years","medinfo@kitepharma.com","Medical Information","1-844-454-5483(1-844-454-KITE)","Brussels, BelgiumPrincipal Investigator: Xavier PoirÃ©, Md Uz Leuven GasthuisbertLeuven, BelgiumPrincipal Investigator: Peter Vandenberghe, Md, Phd|Vancouver, British Columbia, Canada|Winnipeg, Manitoba, Canada, R3E 0V9|Toronto, Ontario, Canada, M5G 2M9|Halifax, Canada, B3H 2Y9|Paris, France, 75475Principal Investigator: Catherine Thieblmont, Md, Phd Centre Hospitalier Lyon-Sud - Service D'Hematologie CliniquePierre Benite, France, 69495Principal Investigator: Gilles Salles, Md|Dresden, Germany, 01307Principal Investigator: Martin Wermke, Md Universitatsklinikum Hamburg-EppendorfHamburg, Germany, 20246Principal Investigator: Nicolaus KrÃ¶ger, Md UniversitÃ¤tsklinikum HeidelbergHeidelberg, Germany, 69120Principal Investigator: Peter Dreger, Md Universitatsklinikum MunsterMÃ¼nster, Germany, 48149Principal Investigator: Matthias Stelljes, Md UniversitÃ¤ts-Klinikum WÃ¼rzburgWÃ¼rzburg, Germany, 97080Principal Investigator: Max Topp, Md|Tel Aviv, Israel, 62431Principal Investigator: Irit Avivi, Md|Amsterdam, Netherlands, 1105 AzPrincipal Investigator: Marie JosÃ© Kersten, Md, Phd University Medical Center GroningenGroningen, Netherlands, 9700 RbPrincipal Investigator: Tom Van Meerten, Md, Phd Universitair Mendisch Centrum UtrechtUtrecht, NetherlandsPrincipal Investigator: Monique Minnema, Md, Phd|Barcelona, Spain, 08036Principal Investigator: Armando LÃ³pez-Guillermo, Md, Phd Institut Catala D'Oncologia De L'HospitaletBarcelona, Spain, 08908|Birmingham, United Kingdom, B15 2GwPrincipal Investigator: Sridhar Chaganti, Md Barts Health Nhs TrustLondon, United Kingdom, Ec1A 7BePrincipal Investigator: Simon Hallam, Md The Christie Nhs Foundation TrustManchester, United Kingdom, M20 4BxPrincipal Investigator: John Radford, Md The Royal Marsden Nhs Foundation TrustSutton, United Kingdom, Sm2 5PtPrincipal Investigator: David Cunningham, Md|Gilbert, Arizona, United States, 85234|San Diego, California, United States, 92093-0698|Miami, Florida, United States, 33136|Chicago, Illinois, United States, 60612Principal Investigator: Reem Karmali, Md University Of ChicagoChicago, Illinois, United States, 60637|Iowa City, Iowa, United States, 52242|Kansas City, Kansas, United States, 66160|Baltimore, Maryland, United States, 21201|Boston, Massachusetts, United States, 02215|Detroit, Michigan, United States, 48201Principal Investigator: Abhinav Deol, Md|Rochester, Minnesota, United States, 55905|Saint Louis, Missouri, United States, 63130|Hackensack, New Jersey, United States, 07601|New York, New York, United States, 10029|Cleveland, Ohio, United States, 44195|Pittsburgh, Pennsylvania, United States, 15213|Nashville, Tennessee, United States, 37203|Houston, Texas, United States, 77030|Salt Lake City, Utah, United States, 84112Principal Investigator: Catherine Lee, Md|Charlottesville, Virginia, United States, 22908|Seattle, Washington, United States, 98104","Arizona|California|Florida|Illinois|Iowa|Kansas|Maryland|Massachusetts|Michigan|Minnesota|Missouri|New Jersey|New York|Ohio|Pennsylvania|Tennessee|Texas|Utah|Virginia|Washington","Belgium|Canada|France|Germany|Israel|Netherlands|Spain|United Kingdom|United States","Cliniques Universiaires Saint-Luc|British Columbia Vancouver General Hospital|Manitoba Cancercare Manitoba|Ontario Princess Margaret Hospital|Qeii Health Sciences Centre|Hopital Saint-Louis|UniversitÃ¤ts-Klinikum Dresden|Tel Aviv Souraski Medical Center|Academic Medical Center Amsterdam|Hospital Clinic De Barcelona|University Hospitals Birmingham Nhs Foundation Trust|Banner Md Anderson Cancer Center|Uc San Diego Moores Cancer Center|University Of Miami|Northwestern University|University Of Iowa|University Of Kansas Medical Center|University Of Maryland|Dana-Farber Cancer Institute|Karmanos Cancer Institute|Mayo Clinic|Washington University|Hackensack University Medical Center|Icahn School Of Medicine At Mount Sinai|Cleveland Clinic|University Of Pittsburgh Medical Center|Sarah Cannon Research Institute|Md Anderson Cancer Center|Huntsman Cancer Institute|University Of Virginia Health System|Swedish Cancer Institute",{"$nulls":3},"Kite Study Director","2019-03-06","2020-05-25T16:35:20.677","2020-05-26T17:10:42.972","NCT03391466"]
["5ecbf3c8fe30261b1a0481af","NCT03391466","2019-04-02","Gilead Sciences","GILD","Recruiting","Efficacy of Axicabtagene Ciloleucel Compared to Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma (ZUMA-7)","Axicabtagene ciloleucel|Cyclophosphamide|Fludarabine|Autologous stem cell transplant","CAR-T|Immunomodulator|STAT1 Inhibitor|Autologous Cell Therapy","Yes","['Axicabtagene ciloleucel']","Yes","['CAR-T', 'Autologous Cell Therapy']","Phase 3",2,350,"Anticipated","2017-12-14","2022-01-15","EFS","Event Free Survival",{"$nulls":3},"The purpose of this study is to evaluate whether axicabtagene ciloleucel therapy improves the clinical outcome compared with standard of care second-line therapy in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL).","This is a phase 3 randomized, open-label, multicenter study evaluating the efficacy of axicabtagene ciloleucel versus standard of care therapy in subjects with relapsed/refractory DLBCL. Adult subjects with relapsed/refractory DLBCL after first-line rituximab and anthracycline-based chemotherapy will be randomized in a 1:1 ratio to receive axicabtagene ciloleucel or standard of care second-line therapy.\n\nStandard of care will consist of a protocol-defined, platinum-based salvage combination chemotherapy regimen followed by high-dose therapy and autologous stem cell transplant in those who respond to salvage chemotherapy.","A Phase 3, Randomized, Open-Label Study Evaluating Efficacy of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma","KTE-C19-107","Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)","Diffuse Large B-Cell Lymphoma|Lymphoma|Lymphoma, B-Cell","Oncology Hematological","Oncology","Experimental|Active Comparator","Axicabtagene Ciloleucel Treatment|Standard of Care Therapy",null,"Biological|Drug","Axicabtagene Ciloleucel|Cyclophosphamide|Fludarabine|Platinum-containing salvage chemotherapy (eg, R-ICE) followed by high dose therapy (eg, BEAM) and autologous stem cell transplant in responders.","A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells administered intravenously following a conditioning chemotherapy regimen of fludarabine and cyclophosphamide|Administered intravenously|Platinum-containing salvage chemotherapy (R-ICE, R-DHAP, R-ESHAP, or R-GDP as selected by treating investigator) followed by high dose therapy (eg, BEAM) and autologous stem cell transplant in responders.","KTE-C19 | axi-cel","Axicabtagene Ciloleucel Treatment|Standard of Care Therapy","\n\n 1. Histologically proven DLBCL, including transformation from follicular lymphoma\n 2. Relapsed or refractory disease after first-line chemoimmunotherapy * Refractory disease is defined as no complete remission to first-line therapy; individuals who are intolerant to first-line therapy are excluded. * Progressive disease (PD) as best response to first-line therapy\n        * Stable disease (SD) as best response after at least 4 cycles of first-line therapy\n        * Partial response (PR) as best response after at least 6 cycles and biopsy-proven residual disease or disease progression â‰¤ 12 months from initiation of therapy\n       \n       \n     * Relapsed disease defined as complete remission to first-line therapy followed by biopsy-proven relapse â‰¤ 12 months of initiating first-line therapy\n    \n    \n 3. Individuals must have received adequate first-line therapy including at a minimum: * Anti-CD20 monoclonal antibody unless investigator determines that tumor is CD20 negative, and\n     * An anthracycline containing chemotherapy regimen\n    \n    \n 4. No known history or suspicion of central nervous system involvement by lymphoma\n 5. Eastern cooperative oncology group (ECOG) performance status of 0 or 1\n 6. Adequate bone marrow function as evidenced by: * Absolute neutrophil count (ANC) â‰¥ 1000/uL\n     * Platelet â‰¥ 75,000/uL\n     * Absolute lymphocyte count â‰¥ 100/uL\n    \n    \n 7. Adequate renal, hepatic, cardiac, and pulmonary function as evidenced by: * Creatinine clearance (Cockcroft Gault) â‰¥ 60 mL/min\n     * Serum Alanine aminotransferase/Aspartate aminotransferase (ALT/AST) â‰¤ 2.5 Upper limit of normal (ULN)\n     * Total bilirubin â‰¤ 1.5 mg/dl\n     * Cardiac ejection fraction â‰¥ 50%, no evidence of pericardial effusion as determined by an Echocardiogram (ECHO), and no clinically significant Electrocardiogram (ECG) findings\n     * No clinically significant pleural effusion\n     * Baseline oxygen saturation > 92% on room air\n    \n    \n\nKey ","\n\n 1.  History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (eg cervix, bladder, breast) unless disease free for at least 3 years\n 2.  Received more than one line of therapy for DLBCL\n 3.  History of autologous or allogeneic stem cell transplant\n 4.  Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring intravenous antimicrobials for management.\n 5.  Known history of infection with human immunodeficiency virus (HIV) or hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive). If there is a positive history of treated hepatitis B or hepatitis C, the viral load must be undetectable per quantitative polymerase chain reaction (PCR) and/or nucleic acid testing.\n 6.  Individuals with detectable cerebrospinal fluid malignant cells or known brain metastases, or with a history of cerebrospinal fluid malignant cells or brain metastases.\n 7.  History or presence of non-malignant central nervous system (CNS) disorder such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement\n 8.  Presence of any indwelling line or drain. Dedicated central venous access catheter such as a Port-a-Cath or Hickman catheter are permitted.\n 9.  History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, New York Heart Association Class II or greater congestive heart failure, or other clinically significant cardiac diseases within 12 months of enrollment\n 10. History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months of enrollment\n 11. History of autoimmune disease, requiring systemic immunosuppression and/or systemic disease modifying agents within the last 2 years\n 12. History of anti-CD19 or CAR-T therapy or history of prior randomization in ZUMA-7\n\nNote: Other protocol defined Inclusion/Exclusion criteria may apply",{"$nulls":4},"Actual","2018-01-05","Actual","Anticipated","2035-01-15","Anticipated","2019-03-01","2017-12-21","2017-12-29","2019-03-29","Yes",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No","Yes","Cheson BD, Fisher RI, Barrington SF, Cavalli F, Schwartz LH, Zucca E, Lister TA; Alliance, Australasian Leukaemia and Lymphoma Group; Eastern Cooperative Oncology Group; European Mantle Cell Lymphoma Consortium; Italian Lymphoma Foundation; European Organisation for Research; Treatment of Cancer/Dutch Hemato-Oncology Group; Grupo EspaÃ±ol de MÃ©dula Ã“sea; German High-Grade Lymphoma Study Group; German Hodgkin's Study Group; Japanese Lymphorra Study Group; Lymphoma Study Association; NCIC Clinical Trials Group; Nordic Lymphoma Study Group; Southwest Oncology Group; United Kingdom National Cancer Research Institute. Recommendations for initial evaluation, staging, and response assessment of Hodgkin and non-Hodgkin lymphoma: the Lugano classification. J Clin Oncol. 2014 Sep 20;32(27):3059-68. PubMed 25113753",null,null,"Yes","No",{"$nulls":17},"2017-002261-22","EudraCT Number","Event Free Survival","Event free survival is defined as the time from randomization to the earliest date of disease progression per Lugano Classification (Cheson et al, 2014), commencement of new lymphoma therapy, or death from any cause as determined by blinded central review","Up to 5 years","Objective Response Rate (ORR)|Overall Survival","Objective response rate is defined as the incidence of either a complete response or a partial response by the Lugano Classification (Cheson et al, 2014) as determined by blinded central review|Overall survival is defined as the time from randomization to death from any cause","Up to 5 years","medinfo@kitepharma.com","Medical Information","1-844-454-5483(1-844-454-KITE)","Graz, Austria, 6020Principal Investigator: Hildegard Greinix, Md Medizinische Universitat Innsbruck, Innere Medizin V - Hamatologie Und OnkologieInnsbruck, Austria, 6020Principal Investigator: Jakob Rudzki, Md|Brussels, BelgiumPrincipal Investigator: Xavier PoirÃ©, Md Uz GasthuisbergLeuven, BelgiumPrincipal Investigator: Peter Vandenberghe, Md, Phd|Vancouver, British Columbia, Canada|Winnipeg, Manitoba, Canada, R3E 0V9|Toronto, Ontario, Canada, M5G 2M9|Halifax, Canada, B3H 2Y9|Paris, France, 75475Principal Investigator: Catherine Thieblmont, Md, Phd Centre Hospitalier Lyon-Sud - Service D'Hematologie CliniquePierre Benite, France, 69495Principal Investigator: Gilles Salles, Md Centre Hospitalier Universitaire De Rennes - Hopital PontchaillouRennes, France, 35033|Dresden, Germany, 01307Principal Investigator: Martin Wermke, Md Universitatsklinikum Hamburg-EppendorfHamburg, Germany, 20246Principal Investigator: Nicolaus KrÃ¶ger, Md UniversitÃ¤tsklinikum HeidelbergHeidelberg, Germany, 69120Principal Investigator: Peter Dreger, Md Universitatsklinikum MunsterMÃ¼nster, Germany, 48149Principal Investigator: Matthias Stelljes, Md UniversitÃ¤ts-Klinikum WÃ¼rzburgWÃ¼rzburg, Germany, 97080Principal Investigator: Max Topp, Md|Tel Aviv, Israel, 62431Principal Investigator: Irit Avivi, Md|Bologna, Italy, 40138Principal Investigator: Pier Luigi Zinzani, Md|Amsterdam, Netherlands, 1105 AzPrincipal Investigator: Marie JosÃ© Kersten, Md, Phd University Medical Center GroningenGroningen, Netherlands, 9700 RbPrincipal Investigator: Tom Van Meerten, Md, Phd University Medical Center UtrechtUtrecht, NetherlandsPrincipal Investigator: Monique Minnema, Md, Phd|Barcelona, Spain, 08036Principal Investigator: Armando LÃ³pez-Guillermo, Md, Phd Institut Catala D'OncologiaBarcelona, Spain, 08908|Lund, Sweden, Se 221 85Principal Investigator: Mats Jerkeman, Md Uppsala Akademiska SjukhusUppsala, Sweden, 75185|Birmingham, United Kingdom, B15 2GwPrincipal Investigator: Sridhar Chaganti, Md Barts Health Nhs TrustLondon, United Kingdom, Ec1A 7BePrincipal Investigator: Simon Hallam, Md The Christie Nhs Foundation TrustManchester, United Kingdom, M20 4BxPrincipal Investigator: John Radford, Md The Royal Marsden Nhs Foundation TrustSutton, United Kingdom, Sm2 5PtPrincipal Investigator: David Cunningham, Md|Gilbert, Arizona, United States, 85234|San Diego, California, United States, 92093-0698|Miami, Florida, United States, 33136|Chicago, Illinois, United States, 60612Principal Investigator: Reem Karmali, Md University Of Chicago Medical CenterChicago, Illinois, United States, 60637|Iowa City, Iowa, United States, 52242|Kansas City, Kansas, United States, 66160|Baltimore, Maryland, United States, 21201|Boston, Massachusetts, United States, 02215|Detroit, Michigan, United States, 48201Principal Investigator: Abhinav Deol, Md|Rochester, Minnesota, United States, 55905|Saint Louis, Missouri, United States, 63130|Hackensack, New Jersey, United States, 07601|New York, New York, United States, 10029|Cleveland, Ohio, United States, 44195|Pittsburgh, Pennsylvania, United States, 15213|Nashville, Tennessee, United States, 37203|Houston, Texas, United States, 77030|Salt Lake City, Utah, United States, 84112Principal Investigator: Catherine Lee, Md|Charlottesville, Virginia, United States, 22908|Seattle, Washington, United States, 98104","Arizona|California|Florida|Illinois|Iowa|Kansas|Maryland|Massachusetts|Michigan|Minnesota|Missouri|New Jersey|New York|Ohio|Pennsylvania|Tennessee|Texas|Utah|Virginia|Washington","Austria|Belgium|Canada|France|Germany|Israel|Italy|Netherlands|Spain|Sweden|United Kingdom|United States","Universitatsklinikum Graz, Division Of Hematology|Cliniques Universiaires Saint-Luc|British Columbia Vancouver General Hospital|Manitoba Cancercare Manitoba|Ontario Uninversity Health Network - Princess Margaret Cancer Center|Qeii Health Sciences Centre|Hopital Saint-Louis|UniversitÃ¤ts-Klinikum Dresden|Tel Aviv Sourasky Medical Center|Instituto Di Ematologia \"L. E A. Seragnoli\" - Dipartimento Di Medicina Specialistica Diagnostica E Sperimentale|Academic Medical Center|Hospital Clinic De Barcelona|Skane University Hospital|University Hospitals Birmingham Nhs Foundation Trust|Banner Md Anderson Cancer Center|Uc San Diego Moores Cancer Center|University Of Miami Hospital And Clinics/Sylvester Comprehensive Cancer Center|Northwestern University|University Of Iowa Hospitals And Clinincs|The University Of Kansas Cancer Center|University Of Maryland, Greenbaum Comprehensive Cancer Center|Dana-Farber Cancer Institute|Barbara Ann Karmanos Cancer Institute|Mayo Clinic, Patient Location|Washington University School Of Medicine|John Theurer Cancer Center At Hackensack University Medical Center|Icahn School Of Medicine At Mount Sinai|Cleveland Clinic|Upmc Hillman Cancer Center|Sarah Cannon Research Institute|The University Of Texas, Md Anderson Cancer Center|University Of Utah, Huntsman Cancer Institute|University Of Virginia Health System|Swedish Cancer Institute",{"$nulls":3},"Kite Study Director","2019-03-29","2020-05-25T16:35:20.911","2020-05-26T17:10:42.972","NCT03391466"]
["5ecbf3c911702c1b1b9169c3","NCT03391466","2019-05-09","Gilead Sciences","GILD","Recruiting","Efficacy of Axicabtagene Ciloleucel Compared to Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma (ZUMA-7)","Axicabtagene ciloleucel|Cyclophosphamide|Fludarabine|Autologous stem cell transplant","CAR-T|Immunomodulator|STAT1 Inhibitor|Autologous Cell Therapy","Yes","['Axicabtagene ciloleucel']","Yes","['CAR-T', 'Autologous Cell Therapy']","Phase 3",2,350,"Anticipated","2017-12-14","2022-01-15","EFS","Event Free Survival",{"$nulls":3},"The purpose of this study is to evaluate whether axicabtagene ciloleucel therapy improves the clinical outcome compared with standard of care second-line therapy in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL).","This is a phase 3 randomized, open-label, multicenter study evaluating the efficacy of axicabtagene ciloleucel versus standard of care therapy in subjects with relapsed/refractory DLBCL. Adult subjects with relapsed/refractory DLBCL after first-line rituximab and anthracycline-based chemotherapy will be randomized in a 1:1 ratio to receive axicabtagene ciloleucel or standard of care second-line therapy.\n\nStandard of care will consist of a protocol-defined, platinum-based salvage combination chemotherapy regimen followed by high-dose therapy and autologous stem cell transplant in those who respond to salvage chemotherapy.","A Phase 3, Randomized, Open-Label Study Evaluating Efficacy of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma","KTE-C19-107","Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)","Diffuse Large B-Cell Lymphoma|Lymphoma|Lymphoma, B-Cell","Oncology Hematological","Oncology","Experimental|Active Comparator","Axicabtagene Ciloleucel Treatment|Standard of Care Therapy",null,"Biological|Drug","Axicabtagene Ciloleucel|Cyclophosphamide|Fludarabine|Platinum-containing salvage chemotherapy (eg, R-ICE) followed by high dose therapy (eg, BEAM) and autologous stem cell transplant in responders.","A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells administered intravenously following a conditioning chemotherapy regimen of fludarabine and cyclophosphamide|Administered intravenously|Platinum-containing salvage chemotherapy (R-ICE, R-DHAP, R-ESHAP, or R-GDP as selected by treating investigator) followed by high dose therapy (eg, BEAM) and autologous stem cell transplant in responders.","KTE-C19 | axi-cel","Axicabtagene Ciloleucel Treatment|Standard of Care Therapy","\n\n 1. Histologically proven large B-cell lymphoma including the following types defined by WHO 2016 (Swerdlow et al, 2016) * DLBCL not otherwise specified (ABC/GCB)\n     * HGBL with or without MYC and BCL2 and/or BCL6 rearrangement\n     * DLBCL arising from FL\n     * T-cell/histiocyte rich large B-cell lymphoma\n     * DLBCL associated with chronic inflammation\n     * Primary cutaneous DLBCL, leg type\n     * Epstein-Barr virus (EBV) + DLBCL\n    \n    \n 2. Relapsed or refractory disease after first-line chemoimmunotherapy * Refractory disease defined as no complete remission to first-line therapy; individuals who are intolerant to first-line therapy are excluded. * Progressive disease (PD) as best response to first-line therapy\n        * Stable disease (SD) as best response after at least 4 cycles of first-line therapy (eg, 4 cycles of R-CHOP)\n        * Partial response (PR) as best response after at least 6 cycles and biopsy-proven residual disease or disease progression â‰¤ 12 months of therapy\n       \n       \n     * Relapsed disease defined as complete remission to first-line therapy followed by biopsy-proven relapse â‰¤ 12 months of first-line therapy\n    \n    \n 3. Individuals must have received adequate first-line therapy including at a minimum: * Anti-CD20 monoclonal antibody unless investigator determines that tumor is CD20 negative, and\n     * An anthracycline containing chemotherapy regimen\n    \n    \n 4. No known history or suspicion of central nervous system involvement by lymphoma\n 5. Eastern cooperative oncology group (ECOG) performance status of 0 or 1\n 6. Adequate bone marrow function as evidenced by: * Absolute neutrophil count (ANC) â‰¥ 1000/uL\n     * Platelet â‰¥ 75,000/uL\n     * Absolute lymphocyte count â‰¥ 100/uL\n    \n    \n 7. Adequate renal, hepatic, cardiac, and pulmonary function as evidenced by: * Creatinine clearance (Cockcroft Gault) â‰¥ 60 mL/min\n     * Serum Alanine aminotransferase/Aspartate aminotransferase (ALT/AST) â‰¤ 2.5 Upper limit of normal (ULN)\n     * Total bilirubin â‰¤ 1.5 mg/dl\n     * Cardiac ejection fraction â‰¥ 50%, no evidence of pericardial effusion as determined by an Echocardiogram (ECHO), and no clinically significant Electrocardiogram (ECG) findings\n     * No clinically significant pleural effusion\n     * Baseline oxygen saturation > 92% on room air\n    \n    \n\nKey ","\n\n 1.  History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (eg cervix, bladder, breast) unless disease free for at least 3 years\n 2.  Received more than one line of therapy for DLBCL\n 3.  History of autologous or allogeneic stem cell transplant\n 4.  Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring intravenous antimicrobials for management.\n 5.  Known history of infection with human immunodeficiency virus (HIV) or hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive). If there is a positive history of treated hepatitis B or hepatitis C, the viral load must be undetectable per quantitative polymerase chain reaction (PCR) and/or nucleic acid testing.\n 6.  Individuals with detectable cerebrospinal fluid malignant cells or known brain metastases, or with a history of cerebrospinal fluid malignant cells or brain metastases.\n 7.  History or presence of non-malignant central nervous system (CNS) disorder such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement\n 8.  Presence of any indwelling line or drain. Dedicated central venous access catheter such as a Port-a-Cath or Hickman catheter are permitted.\n 9.  History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, New York Heart Association Class II or greater congestive heart failure, or other clinically significant cardiac diseases within 12 months of enrollment\n 10. History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months of enrollment\n 11. History of autoimmune disease, requiring systemic immunosuppression and/or systemic disease modifying agents within the last 2 years\n 12. History of anti-CD19 or CAR-T therapy or history of prior randomization in ZUMA-7\n\nNote: Other protocol defined Inclusion/Exclusion criteria may apply","MYC","MYC proto-oncogene, bHLH transcription factor","Gene","Breast, Lung","Actual","2018-01-05","Actual","Anticipated","2035-01-15","Anticipated","2019-05-01","2017-12-21","2017-12-29","2019-05-07","Yes",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No","Yes","Cheson BD, Fisher RI, Barrington SF, Cavalli F, Schwartz LH, Zucca E, Lister TA; Alliance, Australasian Leukaemia and Lymphoma Group; Eastern Cooperative Oncology Group; European Mantle Cell Lymphoma Consortium; Italian Lymphoma Foundation; European Organisation for Research; Treatment of Cancer/Dutch Hemato-Oncology Group; Grupo EspaÃ±ol de MÃ©dula Ã“sea; German High-Grade Lymphoma Study Group; German Hodgkin's Study Group; Japanese Lymphorra Study Group; Lymphoma Study Association; NCIC Clinical Trials Group; Nordic Lymphoma Study Group; Southwest Oncology Group; United Kingdom National Cancer Research Institute. Recommendations for initial evaluation, staging, and response assessment of Hodgkin and non-Hodgkin lymphoma: the Lugano classification. J Clin Oncol. 2014 Sep 20;32(27):3059-68. PubMed 25113753",null,null,"Yes","No",{"$nulls":17},"2017-002261-22","EudraCT Number","Event Free Survival","Event free survival is defined as the time from randomization to the earliest date of disease progression per Lugano Classification (Cheson et al, 2014), commencement of new lymphoma therapy, or death from any cause as determined by blinded central review","Up to 5 years","Objective Response Rate (ORR)|Overall Survival","Objective response rate is defined as the incidence of either a complete response or a partial response by the Lugano Classification (Cheson et al, 2014) as determined by blinded central review|Overall survival is defined as the time from randomization to death from any cause","Up to 5 years","medinfo@kitepharma.com","Medical Information","1-844-454-5483(1-844-454-KITE)","Graz, Austria, 6020 Medizinische Universitat Innsbruck, Innere Medizin V - Hamatologie Und OnkologieInnsbruck, Austria, 6020|Brussels, Belgium Uz GasthuisbergLeuven, Belgium|Vancouver, British Columbia, Canada|Winnipeg, Manitoba, Canada, R3E 0V9|Toronto, Ontario, Canada, M5G 2M9|Halifax, Canada, B3H 2Y9|Lille Cedex, France, 59037 Centre Hospitalier Universataire De NantesNantes, France, 44000 Hopital Saint-LouisParis, France, 75475 Centre Hospitalier Lyon-Sud - Service D'Hematologie CliniquePierre Benite, France, 69495 Centre Hospitalier Universitaire De Rennes - Hopital PontchaillouRennes, France, 35033|Dresden, Germany, 01307 Universitatsklinikum Hamburg-EppendorfHamburg, Germany, 20246 UniversitÃ¤tsklinikum HeidelbergHeidelberg, Germany, 69120 Universitatsklinikum MunsterMÃ¼nster, Germany, 48149 UniversitÃ¤ts-Klinikum WÃ¼rzburgWÃ¼rzburg, Germany, 97080|Tel Aviv, Israel, 62431Principal Investigator: Irit Avivi, Md|Bologna, Italy, 40138|Amsterdam, Netherlands, 1105 Az University Medical Center GroningenGroningen, Netherlands, 9700 Rb Erasmus Medical CenterRotterdam, Netherlands, 3011Pl University Medical Center UtrechtUtrecht, Netherlands|Barcelona, Spain, 08036 Institut Catala D'OncologiaBarcelona, Spain, 08908 Hospital Universitario La PazMadrid, Spain, 28046 Clinica Universidad De NavarraPamplona, Spain, 31008 Hospital Universitario De SalamancaSalamanca, Spain, 37007|Lund, Sweden, Se 221 85 Uppsala Akademiska SjukhusUppsala, Sweden, 75185|Birmingham, United Kingdom, B15 2Gw Barts Health Nhs TrustLondon, United Kingdom, Ec1A 7Be University College London Hospitals Nhs Foundation TrustLondon, United Kingdom, Nw3 2Qg The Christie Nhs Foundation TrustManchester, United Kingdom, M20 4Bx The Royal Marsden Nhs Foundation TrustSutton, United Kingdom, Sm2 5Pt|Gilbert, Arizona, United States, 85234|San Diego, California, United States, 92093-0698|Miami, Florida, United States, 33136|Chicago, Illinois, United States, 60612Principal Investigator: Reem Karmali, Md University Of Chicago Medical CenterChicago, Illinois, United States, 60637|Iowa City, Iowa, United States, 52242|Kansas City, Kansas, United States, 66160|Baltimore, Maryland, United States, 21201|Boston, Massachusetts, United States, 02215|Detroit, Michigan, United States, 48201Principal Investigator: Abhinav Deol, Md|Rochester, Minnesota, United States, 55905|Saint Louis, Missouri, United States, 63130|Hackensack, New Jersey, United States, 07601|New York, New York, United States, 10029|Cleveland, Ohio, United States, 44195|Philadelphia, Pennsylvania, United States, 19107|Nashville, Tennessee, United States, 37203|Houston, Texas, United States, 77030|Salt Lake City, Utah, United States, 84112Principal Investigator: Catherine Lee, Md|Charlottesville, Virginia, United States, 22908|Seattle, Washington, United States, 98104","Arizona|California|Florida|Illinois|Iowa|Kansas|Maryland|Massachusetts|Michigan|Minnesota|Missouri|New Jersey|New York|Ohio|Pennsylvania|Tennessee|Texas|Utah|Virginia|Washington","Austria|Belgium|Canada|France|Germany|Israel|Italy|Netherlands|Spain|Sweden|United Kingdom|United States","Universitatsklinikum Graz, Division Of Hematology|Cliniques Universiaires Saint-Luc|British Columbia Vancouver General Hospital|Manitoba Cancercare Manitoba|Ontario Uninversity Health Network - Princess Margaret Cancer Center|Qeii Health Sciences Centre|Chru De Lille - Hopital Claude Huriez|UniversitÃ¤ts-Klinikum Dresden|Tel Aviv Sourasky Medical Center|Instituto Di Ematologia \"L. E A. Seragnoli\" - Dipartimento Di Medicina Specialistica Diagnostica E Sperimentale|Academic Medical Center|Hospital Clinic De Barcelona|Skane University Hospital|University Hospitals Birmingham Nhs Foundation Trust|Banner Md Anderson Cancer Center|Uc San Diego Moores Cancer Center|University Of Miami Hospital And Clinics/Sylvester Comprehensive Cancer Center|Northwestern University|University Of Iowa Hospitals And Clinincs|The University Of Kansas Cancer Center|University Of Maryland, Greenbaum Comprehensive Cancer Center|Dana-Farber Cancer Institute|Barbara Ann Karmanos Cancer Institute|Mayo Clinic, Patient Location|Washington University School Of Medicine|John Theurer Cancer Center At Hackensack University Medical Center|Icahn School Of Medicine At Mount Sinai|Cleveland Clinic|Thomas Jefferson University|Sarah Cannon Research Institute|The University Of Texas, Md Anderson Cancer Center|University Of Utah, Huntsman Cancer Institute|University Of Virginia Health System|Swedish Cancer Institute",{"$nulls":3},"Kite Study Director","2019-05-07","2020-05-25T16:35:21.102","2020-05-26T17:10:42.972","NCT03391466"]
["5ecbf3c9feab101b155307df","NCT03391466","2019-06-24","Gilead Sciences","GILD","Recruiting","Efficacy of Axicabtagene Ciloleucel Compared to Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma (ZUMA-7)","Axicabtagene ciloleucel|Cyclophosphamide|Fludarabine|Autologous stem cell transplant","CAR-T|Immunomodulator|STAT1 Inhibitor|Autologous Cell Therapy","Yes","['Axicabtagene ciloleucel']","Yes","['CAR-T', 'Autologous Cell Therapy']","Phase 3",2,350,"Anticipated","2017-12-14","2022-01-15","EFS","Event Free Survival",{"$nulls":3},"The purpose of this study is to evaluate whether axicabtagene ciloleucel therapy improves the clinical outcome compared with standard of care second-line therapy in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL).","This is a phase 3 randomized, open-label, multicenter study evaluating the efficacy of axicabtagene ciloleucel versus standard of care therapy in subjects with relapsed/refractory DLBCL. Adult subjects with relapsed/refractory DLBCL after first-line rituximab and anthracycline-based chemotherapy will be randomized in a 1:1 ratio to receive axicabtagene ciloleucel or standard of care second-line therapy.\n\nStandard of care will consist of a protocol-defined, platinum-based salvage combination chemotherapy regimen followed by high-dose therapy and autologous stem cell transplant in those who respond to salvage chemotherapy.","A Phase 3, Randomized, Open-Label Study Evaluating Efficacy of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma","KTE-C19-107","Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)","Diffuse Large B-Cell Lymphoma|Lymphoma|Lymphoma, B-Cell","Oncology Hematological","Oncology","Experimental|Active Comparator","Axicabtagene Ciloleucel Treatment|Standard of Care Therapy",null,"Biological|Drug","Axicabtagene Ciloleucel|Cyclophosphamide|Fludarabine|Platinum-containing salvage chemotherapy (eg, R-ICE) followed by high dose therapy (eg, BEAM) and autologous stem cell transplant in responders.","A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells administered intravenously following a conditioning chemotherapy regimen of fludarabine and cyclophosphamide|Administered intravenously|Platinum-containing salvage chemotherapy (R-ICE, R-DHAP, R-ESHAP, or R-GDP as selected by treating investigator) followed by high dose therapy (eg, BEAM) and autologous stem cell transplant in responders.","KTE-C19 | axi-cel","Axicabtagene Ciloleucel Treatment|Standard of Care Therapy","\n\n 1. Histologically proven large B-cell lymphoma including the following types defined by WHO 2016 (Swerdlow et al, 2016) * DLBCL not otherwise specified (ABC/GCB)\n     * HGBL with or without MYC and BCL2 and/or BCL6 rearrangement\n     * DLBCL arising from FL\n     * T-cell/histiocyte rich large B-cell lymphoma\n     * DLBCL associated with chronic inflammation\n     * Primary cutaneous DLBCL, leg type\n     * Epstein-Barr virus (EBV) + DLBCL\n    \n    \n 2. Relapsed or refractory disease after first-line chemoimmunotherapy * Refractory disease defined as no complete remission to first-line therapy; individuals who are intolerant to first-line therapy are excluded. * Progressive disease (PD) as best response to first-line therapy\n        * Stable disease (SD) as best response after at least 4 cycles of first-line therapy (eg, 4 cycles of R-CHOP)\n        * Partial response (PR) as best response after at least 6 cycles and biopsy-proven residual disease or disease progression â‰¤ 12 months of therapy\n       \n       \n     * Relapsed disease defined as complete remission to first-line therapy followed by biopsy-proven relapse â‰¤ 12 months of first-line therapy\n    \n    \n 3. Individuals must have received adequate first-line therapy including at a minimum: * Anti-CD20 monoclonal antibody unless investigator determines that tumor is CD20 negative, and\n     * An anthracycline containing chemotherapy regimen\n    \n    \n 4. No known history or suspicion of central nervous system involvement by lymphoma\n 5. Eastern cooperative oncology group (ECOG) performance status of 0 or 1\n 6. Adequate bone marrow function as evidenced by: * Absolute neutrophil count (ANC) â‰¥ 1000/uL\n     * Platelet â‰¥ 75,000/uL\n     * Absolute lymphocyte count â‰¥ 100/uL\n    \n    \n 7. Adequate renal, hepatic, cardiac, and pulmonary function as evidenced by: * Creatinine clearance (Cockcroft Gault) â‰¥ 60 mL/min\n     * Serum Alanine aminotransferase/Aspartate aminotransferase (ALT/AST) â‰¤ 2.5 Upper limit of normal (ULN)\n     * Total bilirubin â‰¤ 1.5 mg/dl\n     * Cardiac ejection fraction â‰¥ 50%, no evidence of pericardial effusion as determined by an Echocardiogram (ECHO), and no clinically significant Electrocardiogram (ECG) findings\n     * No clinically significant pleural effusion\n     * Baseline oxygen saturation > 92% on room air\n    \n    \n\nKey ","\n\n 1.  History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (eg cervix, bladder, breast) unless disease free for at least 3 years\n 2.  Received more than one line of therapy for DLBCL\n 3.  History of autologous or allogeneic stem cell transplant\n 4.  Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring intravenous antimicrobials for management.\n 5.  Known history of infection with human immunodeficiency virus (HIV) or hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive). If there is a positive history of treated hepatitis B or hepatitis C, the viral load must be undetectable per quantitative polymerase chain reaction (PCR) and/or nucleic acid testing.\n 6.  Individuals with detectable cerebrospinal fluid malignant cells or known brain metastases, or with a history of cerebrospinal fluid malignant cells or brain metastases.\n 7.  History or presence of non-malignant central nervous system (CNS) disorder such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement\n 8.  Presence of any indwelling line or drain. Dedicated central venous access catheter such as a Port-a-Cath or Hickman catheter are permitted.\n 9.  History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, New York Heart Association Class II or greater congestive heart failure, or other clinically significant cardiac diseases within 12 months of enrollment\n 10. History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months of enrollment\n 11. History of autoimmune disease, requiring systemic immunosuppression and/or systemic disease modifying agents within the last 2 years\n 12. History of anti-CD19 or CAR-T therapy or history of prior randomization in ZUMA-7\n\nNote: Other protocol defined Inclusion/Exclusion criteria may apply","MYC","MYC proto-oncogene, bHLH transcription factor","Gene","Breast, Lung","Actual","2018-01-05","Actual","Anticipated","2035-01-15","Anticipated","2019-06-01","2017-12-21","2017-12-29","2019-06-20","Yes",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No","Yes","Cheson BD, Fisher RI, Barrington SF, Cavalli F, Schwartz LH, Zucca E, Lister TA; Alliance, Australasian Leukaemia and Lymphoma Group; Eastern Cooperative Oncology Group; European Mantle Cell Lymphoma Consortium; Italian Lymphoma Foundation; European Organisation for Research; Treatment of Cancer/Dutch Hemato-Oncology Group; Grupo EspaÃ±ol de MÃ©dula Ã“sea; German High-Grade Lymphoma Study Group; German Hodgkin's Study Group; Japanese Lymphorra Study Group; Lymphoma Study Association; NCIC Clinical Trials Group; Nordic Lymphoma Study Group; Southwest Oncology Group; United Kingdom National Cancer Research Institute. Recommendations for initial evaluation, staging, and response assessment of Hodgkin and non-Hodgkin lymphoma: the Lugano classification. J Clin Oncol. 2014 Sep 20;32(27):3059-68. PubMed 25113753",null,null,"Yes","No",{"$nulls":17},"2017-002261-22","EudraCT Number","Event Free Survival (EFS)","Event free survival is defined as the time from randomization to the earliest date of disease progression per Lugano Classification (Cheson et al, 2014), commencement of new lymphoma therapy, or death from any cause as determined by blinded central review","Up to 5 years","Objective Response Rate (ORR)|Overall Survival (OS)|Modified Event Free Survival (mEFS)|Progression-Free Survival (PFS)|Duration of Response (DOR)|Percentage of Adverse Events and Clinical Significant Changes in Safety Lab Values, including antibodies to axicabtagene ciloleucel.|Changes in EORTC QLQ-C30 domains|Changes in the EQ-5D-5L index|Change in the VAS scores","Objective response rate is defined as the incidence of either a complete response or a partial response by the Lugano Classification (Cheson et al, 2014) as determined by blinded central review|Overall survival is defined as the time from randomization to death from any cause|Event free survival is defined the same way as EFS, except that failure to attain CR or PR by Day 150 assessment is not considered an event. mEFS will be analyzed per blinded central review and per investigator disease assessments.|Progression Free Survival is defined as the time from randomization to disease progression per Lugano Classification (Cheson et al, 2014) or death from any cause|Duration of Response is derived only among subjects who experience an objective response per Lugano Classification (Cheson et al, 2014) as determined by blinded central review and is defined as the time from first response to disease progression per the Lugano Classification or death from any cause|Up to 5 years","Up to 5 years","medinfo@kitepharma.com","Medical Information","1-844-454-5483(1-844-454-KITE)","Melbourne, Victoria, Australia, 3000Principal Investigator: Andres Jose Maria Ferreri, Md|Graz, Austria, 6020 Medizinische Universitat Innsbruck, Innere Medizin V - Hamatologie Und OnkologieInnsbruck, Austria, 6020|Brussels, Belgium Uz GasthuisbergLeuven, Belgium|Vancouver, British Columbia, Canada|Winnipeg, Manitoba, Canada, R3E 0V9|Toronto, Ontario, Canada, M5G 2M9|Halifax, Canada, B3H 2Y9|Lille Cedex, France, 59037 Centre Hospitalier Universataire De NantesNantes, France, 44000 Hopital Saint-LouisParis, France, 75475 Centre Hospitalier Lyon-Sud - Service D'Hematologie CliniquePierre Benite, France, 69495 Centre Hospitalier Universitaire De Rennes - Hopital PontchaillouRennes, France, 35033|Dresden, Germany, 01307 Universitatsklinikum Hamburg-EppendorfHamburg, Germany, 20246 UniversitÃ¤tsklinikum HeidelbergHeidelberg, Germany, 69120 Universitatsklinikum MunsterMÃ¼nster, Germany, 48149 UniversitÃ¤ts-Klinikum WÃ¼rzburgWÃ¼rzburg, Germany, 97080|Tel Aviv, Israel, 62431Principal Investigator: Irit Avivi, Md|Bologna, Italy, 40138 Irccs Ospedale San Raffaele Di MilanoMilano, Italy, 20132|Amsterdam, Netherlands, 1105 Az University Medical Center GroningenGroningen, Netherlands, 9700 Rb Erasmus Medical CenterRotterdam, Netherlands, 3011Pl University Medical Center UtrechtUtrecht, Netherlands|Barcelona, Spain, 08036 Institut Catala D'OncologiaBarcelona, Spain, 08908 Hospital Universitario La PazMadrid, Spain, 28046 Clinica Universidad De NavarraPamplona, Spain, 31008 Hospital Universitario De SalamancaSalamanca, Spain, 37007|Lund, Sweden, Se 221 85 Uppsala Akademiska SjukhusUppsala, Sweden, 75185|Birmingham, United Kingdom, B15 2Gw Barts Health Nhs TrustLondon, United Kingdom, Ec1A 7Be University College London Hospitals Nhs Foundation TrustLondon, United Kingdom, Nw3 2Qg The Christie Nhs Foundation TrustManchester, United Kingdom, M20 4Bx The Royal Marsden Nhs Foundation TrustSutton, United Kingdom, Sm2 5Pt|Gilbert, Arizona, United States, 85234|San Diego, California, United States, 92093-0698|Miami, Florida, United States, 33136|Chicago, Illinois, United States, 60612Principal Investigator: Reem Karmali, Md University Of Chicago Medical CenterChicago, Illinois, United States, 60637|Iowa City, Iowa, United States, 52242|Kansas City, Kansas, United States, 66160|Baltimore, Maryland, United States, 21201|Boston, Massachusetts, United States, 02215|Detroit, Michigan, United States, 48201Principal Investigator: Abhinav Deol, Md|Rochester, Minnesota, United States, 55905|Saint Louis, Missouri, United States, 63130|Hackensack, New Jersey, United States, 07601|New York, New York, United States, 10029|Cleveland, Ohio, United States, 44195|Philadelphia, Pennsylvania, United States, 19107|Nashville, Tennessee, United States, 37203|Houston, Texas, United States, 77030|Salt Lake City, Utah, United States, 84112Principal Investigator: Catherine Lee, Md|Charlottesville, Virginia, United States, 22908|Seattle, Washington, United States, 98104","Arizona|California|Florida|Illinois|Iowa|Kansas|Maryland|Massachusetts|Michigan|Minnesota|Missouri|New Jersey|New York|Ohio|Pennsylvania|Tennessee|Texas|Utah|Virginia|Washington","Australia|Austria|Belgium|Canada|France|Germany|Israel|Italy|Netherlands|Spain|Sweden|United Kingdom|United States","Victoria Peter Maccallum Cancer Center|Universitatsklinikum Graz, Division Of Hematology|Cliniques Universiaires Saint-Luc|British Columbia Vancouver General Hospital|Manitoba Cancercare Manitoba|Ontario Uninversity Health Network - Princess Margaret Cancer Center|Qeii Health Sciences Centre|Chru De Lille - Hopital Claude Huriez|UniversitÃ¤ts-Klinikum Dresden|Tel Aviv Sourasky Medical Center|Instituto Di Ematologia \"L. E A. Seragnoli\" - Dipartimento Di Medicina Specialistica Diagnostica E Sperimentale|Academic Medical Center|Hospital Clinic De Barcelona|Skane University Hospital|University Hospitals Birmingham Nhs Foundation Trust|Banner Md Anderson Cancer Center|Uc San Diego Moores Cancer Center|University Of Miami Hospital And Clinics/Sylvester Comprehensive Cancer Center|Northwestern University|University Of Iowa Hospitals And Clinincs|The University Of Kansas Cancer Center|University Of Maryland, Greenbaum Comprehensive Cancer Center|Dana-Farber Cancer Institute|Barbara Ann Karmanos Cancer Institute|Mayo Clinic, Patient Location|Washington University School Of Medicine|John Theurer Cancer Center At Hackensack University Medical Center|Icahn School Of Medicine At Mount Sinai|Cleveland Clinic|Thomas Jefferson University|Sarah Cannon Research Institute|The University Of Texas, Md Anderson Cancer Center|University Of Utah, Huntsman Cancer Institute|University Of Virginia Health System|Swedish Cancer Institute",{"$nulls":3},"Kite Study Director","2019-06-20","2020-05-25T16:35:21.057","2020-05-26T17:10:42.972","NCT03391466"]
["5ecbf3c9e2561b1b11905cab","NCT03391466","2019-07-30","Gilead Sciences","GILD","Recruiting","Efficacy of Axicabtagene Ciloleucel Compared to Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma (ZUMA-7)","Axicabtagene ciloleucel|Cyclophosphamide|Fludarabine|Autologous stem cell transplant","CAR-T|Immunomodulator|STAT1 Inhibitor|Autologous Cell Therapy","Yes","['Axicabtagene ciloleucel']","Yes","['CAR-T', 'Autologous Cell Therapy']","Phase 3",2,350,"Anticipated","2017-12-14","2022-01-15","EFS","Event Free Survival",{"$nulls":3},"The purpose of this study is to evaluate whether axicabtagene ciloleucel therapy improves the clinical outcome compared with standard of care second-line therapy in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL).","This is a phase 3 randomized, open-label, multicenter study evaluating the efficacy of axicabtagene ciloleucel versus standard of care therapy in subjects with relapsed/refractory DLBCL. Adult subjects with relapsed/refractory DLBCL after first-line rituximab and anthracycline-based chemotherapy will be randomized in a 1:1 ratio to receive axicabtagene ciloleucel or standard of care second-line therapy.\n\nStandard of care will consist of a protocol-defined, platinum-based salvage combination chemotherapy regimen followed by high-dose therapy and autologous stem cell transplant in those who respond to salvage chemotherapy.","A Phase 3, Randomized, Open-Label Study Evaluating Efficacy of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma","KTE-C19-107","Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)","Diffuse Large B-Cell Lymphoma|Lymphoma|Lymphoma, B-Cell","Oncology Hematological","Oncology","Experimental|Active Comparator","Axicabtagene Ciloleucel Treatment|Standard of Care Therapy",null,"Biological|Drug","Axicabtagene Ciloleucel|Cyclophosphamide|Fludarabine|Platinum-containing salvage chemotherapy (eg, R-ICE) followed by high dose therapy (eg, BEAM) and autologous stem cell transplant in responders.","A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells administered intravenously following a conditioning chemotherapy regimen of fludarabine and cyclophosphamide|Administered intravenously|Platinum-containing salvage chemotherapy (R-ICE, R-DHAP, R-ESHAP, or R-GDP as selected by treating investigator) followed by high dose therapy (eg, BEAM) and autologous stem cell transplant in responders.","KTE-C19 | axi-cel","Axicabtagene Ciloleucel Treatment|Standard of Care Therapy","\n\n 1. Histologically proven large B-cell lymphoma including the following types defined by WHO 2016 (Swerdlow et al, 2016) * DLBCL not otherwise specified (ABC/GCB)\n     * HGBL with or without MYC and BCL2 and/or BCL6 rearrangement\n     * DLBCL arising from FL\n     * T-cell/histiocyte rich large B-cell lymphoma\n     * DLBCL associated with chronic inflammation\n     * Primary cutaneous DLBCL, leg type\n     * Epstein-Barr virus (EBV) + DLBCL\n    \n    \n 2. Relapsed or refractory disease after first-line chemoimmunotherapy * Refractory disease defined as no complete remission to first-line therapy; individuals who are intolerant to first-line therapy are excluded. * Progressive disease (PD) as best response to first-line therapy\n        * Stable disease (SD) as best response after at least 4 cycles of first-line therapy (eg, 4 cycles of R-CHOP)\n        * Partial response (PR) as best response after at least 6 cycles and biopsy-proven residual disease or disease progression â‰¤ 12 months of therapy\n       \n       \n     * Relapsed disease defined as complete remission to first-line therapy followed by biopsy-proven relapse â‰¤ 12 months of first-line therapy\n    \n    \n 3. Individuals must have received adequate first-line therapy including at a minimum: * Anti-CD20 monoclonal antibody unless investigator determines that tumor is CD20 negative, and\n     * An anthracycline containing chemotherapy regimen\n    \n    \n 4. No known history or suspicion of central nervous system involvement by lymphoma\n 5. Eastern cooperative oncology group (ECOG) performance status of 0 or 1\n 6. Adequate bone marrow function as evidenced by: * Absolute neutrophil count (ANC) â‰¥ 1000/uL\n     * Platelet â‰¥ 75,000/uL\n     * Absolute lymphocyte count â‰¥ 100/uL\n    \n    \n 7. Adequate renal, hepatic, cardiac, and pulmonary function as evidenced by: * Creatinine clearance (Cockcroft Gault) â‰¥ 60 mL/min\n     * Serum Alanine aminotransferase/Aspartate aminotransferase (ALT/AST) â‰¤ 2.5 Upper limit of normal (ULN)\n     * Total bilirubin â‰¤ 1.5 mg/dl\n     * Cardiac ejection fraction â‰¥ 50%, no evidence of pericardial effusion as determined by an Echocardiogram (ECHO), and no clinically significant Electrocardiogram (ECG) findings\n     * No clinically significant pleural effusion\n     * Baseline oxygen saturation > 92% on room air\n    \n    \n\nKey ","\n\n 1.  History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (eg cervix, bladder, breast) unless disease free for at least 3 years\n 2.  Received more than one line of therapy for DLBCL\n 3.  History of autologous or allogeneic stem cell transplant\n 4.  Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring intravenous antimicrobials for management.\n 5.  Known history of infection with human immunodeficiency virus (HIV) or hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive). If there is a positive history of treated hepatitis B or hepatitis C, the viral load must be undetectable per quantitative polymerase chain reaction (PCR) and/or nucleic acid testing.\n 6.  Individuals with detectable cerebrospinal fluid malignant cells or known brain metastases, or with a history of cerebrospinal fluid malignant cells or brain metastases.\n 7.  History or presence of non-malignant central nervous system (CNS) disorder such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement\n 8.  Presence of any indwelling line or drain. Dedicated central venous access catheter such as a Port-a-Cath or Hickman catheter are permitted.\n 9.  History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, New York Heart Association Class II or greater congestive heart failure, or other clinically significant cardiac diseases within 12 months of enrollment\n 10. History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months of enrollment\n 11. History of autoimmune disease, requiring systemic immunosuppression and/or systemic disease modifying agents within the last 2 years\n 12. History of anti-CD19 or CAR-T therapy or history of prior randomization in ZUMA-7\n\nNote: Other protocol defined Inclusion/Exclusion criteria may apply","MYC","MYC proto-oncogene, bHLH transcription factor","Gene","Breast, Lung","Actual","2018-01-05","Actual","Anticipated","2035-01-15","Anticipated","2019-07-01","2017-12-21","2017-12-29","2019-07-26","Yes",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No","Yes","Cheson BD, Fisher RI, Barrington SF, Cavalli F, Schwartz LH, Zucca E, Lister TA; Alliance, Australasian Leukaemia and Lymphoma Group; Eastern Cooperative Oncology Group; European Mantle Cell Lymphoma Consortium; Italian Lymphoma Foundation; European Organisation for Research; Treatment of Cancer/Dutch Hemato-Oncology Group; Grupo EspaÃ±ol de MÃ©dula Ã“sea; German High-Grade Lymphoma Study Group; German Hodgkin's Study Group; Japanese Lymphorra Study Group; Lymphoma Study Association; NCIC Clinical Trials Group; Nordic Lymphoma Study Group; Southwest Oncology Group; United Kingdom National Cancer Research Institute. Recommendations for initial evaluation, staging, and response assessment of Hodgkin and non-Hodgkin lymphoma: the Lugano classification. J Clin Oncol. 2014 Sep 20;32(27):3059-68. PubMed 25113753",null,null,"Yes","No",{"$nulls":17},"2017-002261-22","EudraCT Number","Event Free Survival (EFS)","Event free survival is defined as the time from randomization to the earliest date of disease progression per Lugano Classification (Cheson et al, 2014), commencement of new lymphoma therapy, or death from any cause as determined by blinded central review","Up to 5 years","Objective Response Rate (ORR)|Overall Survival (OS)|Modified Event Free Survival (mEFS)|Progression-Free Survival (PFS)|Duration of Response (DOR)|Percentage of Adverse Events and Clinical Significant Changes in Safety Lab Values, including antibodies to axicabtagene ciloleucel.|Changes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Cancer-30 (EORTC QLQ-C30) domains|Changes over time in the European Quality of Life Five Dimensions Five Levels scale(EQ-5D-5L)|Changes over time in the Visual analog scale (VAS) scores","Objective response rate is defined as the incidence of either a complete response or a partial response by the Lugano Classification (Cheson et al, 2014) as determined by blinded central review|Overall survival is defined as the time from randomization to death from any cause|Event free survival is defined the same way as EFS, except that failure to attain CR or PR by Day 150 assessment is not considered an event. mEFS will be analyzed per blinded central review and per investigator disease assessments.|Progression Free Survival is defined as the time from randomization to disease progression per Lugano Classification (Cheson et al, 2014) or death from any cause|Duration of Response is derived only among subjects who experience an objective response per Lugano Classification (Cheson et al, 2014) as determined by blinded central review and is defined as the time from first response to disease progression per the Lugano Classification or death from any cause|Up to 5 years|The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Cancer-30 (EORTC QLQ-C30) is a multi-item questionnaire measuring the following content five (5) multi-item functional scales, three (3) multi-item symptom scales, one (1) global health status scale, and one (1) global health-related quality of life (HRQoL) each scale is measured from 0 to 100 after a linear transformation. Higher scores for functioning scales and for the Global Health Status or Global HRQoL scales indicate a higher level of functioning and a better HRQoL respectively, whereas higher scores in symptom scales represent a higher level of symptoms.|The Euro-QOL, Five Dimensions, Five Levels (EQ-5D-5L) questionnaire is a generic measure of health status that provides a simple descriptive profile and a single index value. The EQ-5D-5L comprises 2 components: a questionnaire covering 5 dimensions and a tariff of values based upon direct valuations of health states using a visual analog scale (VAS).|The EQ-5D-5L VAS is a 20-cm VAS for recording self-rated current HRQoL state and is used to describe the subjects' health status on the day of the assessment. The EQ-5D-5L VAS score is recorded by each subject for his or her current HRQoL state and scored 0 (\"the worst health you can imagine\") to 100 (\"the best health you can imagine\").","Up to 5 years","medinfo@kitepharma.com","Medical Information","1-844-454-5483(1-844-454-KITE)","Melbourne, Victoria, Australia, 3000Principal Investigator: Andres Jose Maria Ferreri, Md|Graz, Austria, 6020 Medizinische Universitat Innsbruck, Innere Medizin V - Hamatologie Und OnkologieInnsbruck, Austria, 6020|Brussels, Belgium Uz GasthuisbergLeuven, Belgium|Vancouver, British Columbia, Canada|Winnipeg, Manitoba, Canada, R3E 0V9|Toronto, Ontario, Canada, M5G 2M9|Halifax, Canada, B3H 2Y9|Lille Cedex, France, 59037 Centre Hospitalier Universataire De NantesNantes, France, 44000 Hopital Saint-LouisParis, France, 75475 Centre Hospitalier Lyon-Sud - Service D'Hematologie CliniquePierre Benite, France, 69495 Centre Hospitalier Universitaire De Rennes - Hopital PontchaillouRennes, France, 35033|Dresden, Germany, 01307 Universitatsmedizin GottingenGÃ¶ttingen, Germany, 37075 Universitatsklinikum Hamburg-EppendorfHamburg, Germany, 20246 UniversitÃ¤tsklinikum HeidelbergHeidelberg, Germany, 69120 Universitatsklinikum MunsterMÃ¼nster, Germany, 48149 UniversitÃ¤ts-Klinikum WÃ¼rzburgWÃ¼rzburg, Germany, 97080|Tel Aviv, Israel, 62431Principal Investigator: Irit Avivi, Md|Bologna, Italy, 40138 Irccs Ospedale San Raffaele Di MilanoMilano, Italy, 20132|Amsterdam, Netherlands, 1105 Az University Medical Center GroningenGroningen, Netherlands, 9700 Rb Erasmus Medical CenterRotterdam, Netherlands, 3011Pl University Medical Center UtrechtUtrecht, Netherlands|Barcelona, Spain, 08036 Institut Catala D'OncologiaBarcelona, Spain, 08908 Hospital Universitario La PazMadrid, Spain, 28046 Clinica Universidad De NavarraPamplona, Spain, 31008 Hospital Universitario De SalamancaSalamanca, Spain, 37007|Lund, Sweden, Se 221 85 Uppsala Akademiska SjukhusUppsala, Sweden, 75185|Bellinzona, Switzerland, 6500 Centre Hospitalier Universitaire Vaudois (Chuv)Lausanne, Switzerland, 1011 University Hospital ZurichZÃ¼rich, Switzerland, 8091|Birmingham, United Kingdom, B15 2Gw Barts Health Nhs TrustLondon, United Kingdom, Ec1A 7Be University College London Hospitals Nhs Foundation TrustLondon, United Kingdom, Nw3 2Qg The Christie Nhs Foundation TrustManchester, United Kingdom, M20 4Bx The Royal Marsden Nhs Foundation TrustSutton, United Kingdom, Sm2 5Pt|Birmingham, Alabama, United States, 35233|Gilbert, Arizona, United States, 85234|San Diego, California, United States, 92093-0698|Miami, Florida, United States, 33136|Chicago, Illinois, United States, 60612Principal Investigator: Reem Karmali, Md University Of Chicago Medical CenterChicago, Illinois, United States, 60637|Iowa City, Iowa, United States, 52242|Kansas City, Kansas, United States, 66160|Baltimore, Maryland, United States, 21201|Boston, Massachusetts, United States, 02215|Detroit, Michigan, United States, 48201Principal Investigator: Abhinav Deol, Md|Rochester, Minnesota, United States, 55905|Saint Louis, Missouri, United States, 63130|Hackensack, New Jersey, United States, 07601|New York, New York, United States, 10029|Cleveland, Ohio, United States, 44195|Philadelphia, Pennsylvania, United States, 19107|Nashville, Tennessee, United States, 37203|Houston, Texas, United States, 77030|Salt Lake City, Utah, United States, 84112Principal Investigator: Catherine Lee, Md|Charlottesville, Virginia, United States, 22908|Seattle, Washington, United States, 98104","Alabama|Arizona|California|Florida|Illinois|Iowa|Kansas|Maryland|Massachusetts|Michigan|Minnesota|Missouri|New Jersey|New York|Ohio|Pennsylvania|Tennessee|Texas|Utah|Virginia|Washington","Australia|Austria|Belgium|Canada|France|Germany|Israel|Italy|Netherlands|Spain|Sweden|Switzerland|United Kingdom|United States","Victoria Peter Maccallum Cancer Center|Universitatsklinikum Graz, Division Of Hematology|Cliniques Universiaires Saint-Luc|British Columbia Vancouver General Hospital|Manitoba Cancercare Manitoba|Ontario Uninversity Health Network - Princess Margaret Cancer Center|Qeii Health Sciences Centre|Chru De Lille - Hopital Claude Huriez|UniversitÃ¤ts-Klinikum Dresden|Tel Aviv Sourasky Medical Center|Instituto Di Ematologia \"L. E A. Seragnoli\" - Dipartimento Di Medicina Specialistica Diagnostica E Sperimentale|Academic Medical Center|Hospital Clinic De Barcelona|Skane University Hospital|Iosi, Ospedale Regionale Bellinzona E Valli|University Hospitals Birmingham Nhs Foundation Trust|University Of Alabama At Birmingham|Banner Md Anderson Cancer Center|Uc San Diego Moores Cancer Center|University Of Miami Hospital And Clinics/Sylvester Comprehensive Cancer Center|Northwestern University|University Of Iowa Hospitals And Clinincs|The University Of Kansas Cancer Center|University Of Maryland, Greenbaum Comprehensive Cancer Center|Dana-Farber Cancer Institute|Barbara Ann Karmanos Cancer Institute|Mayo Clinic, Patient Location|Washington University School Of Medicine|John Theurer Cancer Center At Hackensack University Medical Center|Icahn School Of Medicine At Mount Sinai|Cleveland Clinic|Thomas Jefferson University|Sarah Cannon Research Institute|The University Of Texas, Md Anderson Cancer Center|University Of Utah, Huntsman Cancer Institute|University Of Virginia Health System|Swedish Cancer Institute",{"$nulls":3},"Kite Study Director","2019-07-26","2020-05-25T16:35:21.073","2020-05-26T17:10:42.972","NCT03391466"]
["5ecbf3c9307e3d1b1f8d9c40","NCT03391466","2019-08-12","Gilead Sciences","GILD","Recruiting","Efficacy of Axicabtagene Ciloleucel Compared to Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma (ZUMA-7)","Axicabtagene ciloleucel|Cyclophosphamide|Fludarabine|Autologous stem cell transplant","CAR-T|Immunomodulator|STAT1 Inhibitor|Autologous Cell Therapy","Yes","['Axicabtagene ciloleucel']","Yes","['CAR-T', 'Autologous Cell Therapy']","Phase 3",2,350,"Anticipated","2017-12-14","2022-01-15","EFS","Event Free Survival",{"$nulls":3},"The purpose of this study is to evaluate whether axicabtagene ciloleucel therapy improves the clinical outcome compared with standard of care second-line therapy in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL).","This is a phase 3 randomized, open-label, multicenter study evaluating the efficacy of axicabtagene ciloleucel versus standard of care therapy in subjects with relapsed/refractory DLBCL. Adult subjects with relapsed/refractory DLBCL after first-line rituximab and anthracycline-based chemotherapy will be randomized in a 1:1 ratio to receive axicabtagene ciloleucel or standard of care second-line therapy.\n\nStandard of care will consist of a protocol-defined, platinum-based salvage combination chemotherapy regimen followed by high-dose therapy and autologous stem cell transplant in those who respond to salvage chemotherapy.","A Phase 3, Randomized, Open-Label Study Evaluating Efficacy of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma","KTE-C19-107","Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)","Diffuse Large B-Cell Lymphoma|Lymphoma|Lymphoma, B-Cell","Oncology Hematological","Oncology","Experimental|Active Comparator","Axicabtagene Ciloleucel Treatment|Standard of Care Therapy",null,"Biological|Drug","Axicabtagene Ciloleucel|Cyclophosphamide|Fludarabine|Platinum-containing salvage chemotherapy (eg, R-ICE) followed by high dose therapy (eg, BEAM) and autologous stem cell transplant in responders.","A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells administered intravenously following a conditioning chemotherapy regimen of fludarabine and cyclophosphamide|Administered intravenously|Platinum-containing salvage chemotherapy (R-ICE, R-DHAP, R-ESHAP, or R-GDP as selected by treating investigator) followed by high dose therapy (eg, BEAM) and autologous stem cell transplant in responders.","KTE-C19 | axi-cel","Axicabtagene Ciloleucel Treatment|Standard of Care Therapy","\n\n 1. Histologically proven large B-cell lymphoma including the following types defined by WHO 2016 (Swerdlow et al, 2016) * DLBCL not otherwise specified (ABC/GCB)\n     * HGBL with or without MYC and BCL2 and/or BCL6 rearrangement\n     * DLBCL arising from FL\n     * T-cell/histiocyte rich large B-cell lymphoma\n     * DLBCL associated with chronic inflammation\n     * Primary cutaneous DLBCL, leg type\n     * Epstein-Barr virus (EBV) + DLBCL\n    \n    \n 2. Relapsed or refractory disease after first-line chemoimmunotherapy * Refractory disease defined as no complete remission to first-line therapy; individuals who are intolerant to first-line therapy are excluded. * Progressive disease (PD) as best response to first-line therapy\n        * Stable disease (SD) as best response after at least 4 cycles of first-line therapy (eg, 4 cycles of R-CHOP)\n        * Partial response (PR) as best response after at least 6 cycles and biopsy-proven residual disease or disease progression â‰¤ 12 months of therapy\n       \n       \n     * Relapsed disease defined as complete remission to first-line therapy followed by biopsy-proven relapse â‰¤ 12 months of first-line therapy\n    \n    \n 3. Individuals must have received adequate first-line therapy including at a minimum: * Anti-CD20 monoclonal antibody unless investigator determines that tumor is CD20 negative, and\n     * An anthracycline containing chemotherapy regimen\n    \n    \n 4. No known history or suspicion of central nervous system involvement by lymphoma\n 5. Eastern cooperative oncology group (ECOG) performance status of 0 or 1\n 6. Adequate bone marrow function as evidenced by: * Absolute neutrophil count (ANC) â‰¥ 1000/uL\n     * Platelet â‰¥ 75,000/uL\n     * Absolute lymphocyte count â‰¥ 100/uL\n    \n    \n 7. Adequate renal, hepatic, cardiac, and pulmonary function as evidenced by: * Creatinine clearance (Cockcroft Gault) â‰¥ 60 mL/min\n     * Serum Alanine aminotransferase/Aspartate aminotransferase (ALT/AST) â‰¤ 2.5 Upper limit of normal (ULN)\n     * Total bilirubin â‰¤ 1.5 mg/dl\n     * Cardiac ejection fraction â‰¥ 50%, no evidence of pericardial effusion as determined by an Echocardiogram (ECHO), and no clinically significant Electrocardiogram (ECG) findings\n     * No clinically significant pleural effusion\n     * Baseline oxygen saturation > 92% on room air\n    \n    \n\nKey ","\n\n 1.  History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (eg cervix, bladder, breast) unless disease free for at least 3 years\n 2.  Received more than one line of therapy for DLBCL\n 3.  History of autologous or allogeneic stem cell transplant\n 4.  Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring intravenous antimicrobials for management.\n 5.  Known history of infection with human immunodeficiency virus (HIV) or hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive). If there is a positive history of treated hepatitis B or hepatitis C, the viral load must be undetectable per quantitative polymerase chain reaction (PCR) and/or nucleic acid testing.\n 6.  Individuals with detectable cerebrospinal fluid malignant cells or known brain metastases, or with a history of cerebrospinal fluid malignant cells or brain metastases.\n 7.  History or presence of non-malignant central nervous system (CNS) disorder such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement\n 8.  Presence of any indwelling line or drain. Dedicated central venous access catheter such as a Port-a-Cath or Hickman catheter are permitted.\n 9.  History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, New York Heart Association Class II or greater congestive heart failure, or other clinically significant cardiac diseases within 12 months of enrollment\n 10. History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months of enrollment\n 11. History of autoimmune disease, requiring systemic immunosuppression and/or systemic disease modifying agents within the last 2 years\n 12. History of anti-CD19 or CAR-T therapy or history of prior randomization in ZUMA-7\n\nNote: Other protocol defined Inclusion/Exclusion criteria may apply","MYC","MYC proto-oncogene, bHLH transcription factor","Gene","Breast, Lung","Actual","2018-01-05","Actual","Anticipated","2035-01-15","Anticipated","2019-08-01","2017-12-21","2017-12-29","2019-08-09","Yes",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No","Yes","Cheson BD, Fisher RI, Barrington SF, Cavalli F, Schwartz LH, Zucca E, Lister TA; Alliance, Australasian Leukaemia and Lymphoma Group; Eastern Cooperative Oncology Group; European Mantle Cell Lymphoma Consortium; Italian Lymphoma Foundation; European Organisation for Research; Treatment of Cancer/Dutch Hemato-Oncology Group; Grupo EspaÃ±ol de MÃ©dula Ã“sea; German High-Grade Lymphoma Study Group; German Hodgkin's Study Group; Japanese Lymphorra Study Group; Lymphoma Study Association; NCIC Clinical Trials Group; Nordic Lymphoma Study Group; Southwest Oncology Group; United Kingdom National Cancer Research Institute. Recommendations for initial evaluation, staging, and response assessment of Hodgkin and non-Hodgkin lymphoma: the Lugano classification. J Clin Oncol. 2014 Sep 20;32(27):3059-68. PubMed 25113753",null,null,"Yes","No",{"$nulls":17},"2017-002261-22","EudraCT Number","Event Free Survival (EFS)","Event free survival is defined as the time from randomization to the earliest date of disease progression per Lugano Classification (Cheson et al, 2014), commencement of new lymphoma therapy, or death from any cause as determined by blinded central review","Up to 5 years","Objective Response Rate (ORR)|Overall Survival (OS)|Modified Event Free Survival (mEFS)|Progression-Free Survival (PFS)|Duration of Response (DOR)|Percentage of Adverse Events and Clinical Significant Changes in Safety Lab Values, including antibodies to axicabtagene ciloleucel.|Changes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Cancer-30 (EORTC QLQ-C30) domains|Changes over time in the European Quality of Life Five Dimensions Five Levels scale(EQ-5D-5L)|Changes over time in the Visual analog scale (VAS) scores","Objective response rate is defined as the incidence of either a complete response or a partial response by the Lugano Classification (Cheson et al, 2014) as determined by blinded central review|Overall survival is defined as the time from randomization to death from any cause|Event free survival is defined the same way as EFS, except that failure to attain CR or PR by Day 150 assessment is not considered an event. mEFS will be analyzed per blinded central review and per investigator disease assessments.|Progression Free Survival is defined as the time from randomization to disease progression per Lugano Classification (Cheson et al, 2014) or death from any cause|Duration of Response is derived only among subjects who experience an objective response per Lugano Classification (Cheson et al, 2014) as determined by blinded central review and is defined as the time from first response to disease progression per the Lugano Classification or death from any cause|Up to 5 years|The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Cancer-30 (EORTC QLQ-C30) is a multi-item questionnaire measuring the following content five (5) multi-item functional scales, three (3) multi-item symptom scales, one (1) global health status scale, and one (1) global health-related quality of life (HRQoL) each scale is measured from 0 to 100 after a linear transformation. Higher scores for functioning scales and for the Global Health Status or Global HRQoL scales indicate a higher level of functioning and a better HRQoL respectively, whereas higher scores in symptom scales represent a higher level of symptoms.|The Euro-QOL, Five Dimensions, Five Levels (EQ-5D-5L) questionnaire is a generic measure of health status that provides a simple descriptive profile and a single index value. The EQ-5D-5L comprises 2 components: a questionnaire covering 5 dimensions and a tariff of values based upon direct valuations of health states using a visual analog scale (VAS).|The EQ-5D-5L VAS is a 20-cm VAS for recording self-rated current HRQoL state and is used to describe the subjects' health status on the day of the assessment. The EQ-5D-5L VAS score is recorded by each subject for his or her current HRQoL state and scored 0 (\"the worst health you can imagine\") to 100 (\"the best health you can imagine\").","Up to 5 years","medinfo@kitepharma.com","Medical Information","1-844-454-5483(1-844-454-KITE)","Melbourne, Victoria, Australia, 3000Principal Investigator: Michael Dickinson, Md|Graz, Austria, 6020 Medizinische Universitat Innsbruck, Innere Medizin V - Hamatologie Und OnkologieInnsbruck, Austria, 6020|Brussels, Belgium Uz GasthuisbergLeuven, Belgium|Vancouver, British Columbia, Canada|Winnipeg, Manitoba, Canada, R3E 0V9|Toronto, Ontario, Canada, M5G 2M9|Halifax, Canada, B3H 2Y9|Lille Cedex, France, 59037 Centre Hospitalier Universataire De NantesNantes, France, 44000 Hopital Saint-LouisParis, France, 75475 Centre Hospitalier Lyon-Sud - Service D'Hematologie CliniquePierre Benite, France, 69495 Centre Hospitalier Universitaire De Rennes - Hopital PontchaillouRennes, France, 35033|Dresden, Germany, 01307 Universitatsmedizin GottingenGÃ¶ttingen, Germany, 37075 Universitatsklinikum Hamburg-EppendorfHamburg, Germany, 20246 UniversitÃ¤tsklinikum HeidelbergHeidelberg, Germany, 69120 Universitatsklinikum MunsterMÃ¼nster, Germany, 48149 UniversitÃ¤ts-Klinikum WÃ¼rzburgWÃ¼rzburg, Germany, 97080|Tel Aviv, Israel, 62431Principal Investigator: Irit Avivi, Md|Bologna, Italy, 40138 Irccs Ospedale San Raffaele Di MilanoMilano, Italy, 20132|Amsterdam, Netherlands, 1105 Az University Medical Center GroningenGroningen, Netherlands, 9700 Rb Erasmus Medical CenterRotterdam, Netherlands, 3011Pl University Medical Center UtrechtUtrecht, Netherlands|Barcelona, Spain, 08036 Institut Catala D'OncologiaBarcelona, Spain, 08908 Hospital Universitario La PazMadrid, Spain, 28046 Clinica Universidad De NavarraPamplona, Spain, 31008 Hospital Universitario De SalamancaSalamanca, Spain, 37007|Lund, Sweden, Se 221 85 Uppsala Akademiska SjukhusUppsala, Sweden, 75185|Bellinzona, Switzerland, 6500 Centre Hospitalier Universitaire Vaudois (Chuv)Lausanne, Switzerland, 1011 University Hospital ZurichZÃ¼rich, Switzerland, 8091|Birmingham, United Kingdom, B15 2Gw Barts Health Nhs TrustLondon, United Kingdom, Ec1A 7Be University College London Hospitals Nhs Foundation TrustLondon, United Kingdom, Nw3 2Qg The Christie Nhs Foundation TrustManchester, United Kingdom, M20 4Bx The Royal Marsden Nhs Foundation TrustSutton, United Kingdom, Sm2 5Pt|Birmingham, Alabama, United States, 35233|Gilbert, Arizona, United States, 85234|San Diego, California, United States, 92093-0698|Miami, Florida, United States, 33136|Chicago, Illinois, United States, 60612Principal Investigator: Reem Karmali, Md University Of Chicago Medical CenterChicago, Illinois, United States, 60637|Iowa City, Iowa, United States, 52242|Kansas City, Kansas, United States, 66160|Baltimore, Maryland, United States, 21201|Boston, Massachusetts, United States, 02215|Detroit, Michigan, United States, 48201Principal Investigator: Abhinav Deol, Md|Rochester, Minnesota, United States, 55905|Saint Louis, Missouri, United States, 63130|Hackensack, New Jersey, United States, 07601|New York, New York, United States, 10029|Cleveland, Ohio, United States, 44195|Philadelphia, Pennsylvania, United States, 19107|Nashville, Tennessee, United States, 37203|Houston, Texas, United States, 77030|Salt Lake City, Utah, United States, 84112Principal Investigator: Catherine Lee, Md|Charlottesville, Virginia, United States, 22908|Seattle, Washington, United States, 98104","Alabama|Arizona|California|Florida|Illinois|Iowa|Kansas|Maryland|Massachusetts|Michigan|Minnesota|Missouri|New Jersey|New York|Ohio|Pennsylvania|Tennessee|Texas|Utah|Virginia|Washington","Australia|Austria|Belgium|Canada|France|Germany|Israel|Italy|Netherlands|Spain|Sweden|Switzerland|United Kingdom|United States","Victoria Peter Maccallum Cancer Center|Universitatsklinikum Graz, Division Of Hematology|Cliniques Universiaires Saint-Luc|British Columbia Vancouver General Hospital|Manitoba Cancercare Manitoba|Ontario Uninversity Health Network - Princess Margaret Cancer Center|Qeii Health Sciences Centre|Chru De Lille - Hopital Claude Huriez|UniversitÃ¤ts-Klinikum Dresden|Tel Aviv Sourasky Medical Center|Instituto Di Ematologia \"L. E A. Seragnoli\" - Dipartimento Di Medicina Specialistica Diagnostica E Sperimentale|Academic Medical Center|Hospital Clinic De Barcelona|Skane University Hospital|Iosi, Ospedale Regionale Bellinzona E Valli|University Hospitals Birmingham Nhs Foundation Trust|University Of Alabama At Birmingham|Banner Md Anderson Cancer Center|Uc San Diego Moores Cancer Center|University Of Miami Hospital And Clinics/Sylvester Comprehensive Cancer Center|Northwestern University|University Of Iowa Hospitals And Clinincs|The University Of Kansas Cancer Center|University Of Maryland, Greenbaum Comprehensive Cancer Center|Dana-Farber Cancer Institute|Barbara Ann Karmanos Cancer Institute|Mayo Clinic, Patient Location|Washington University School Of Medicine|John Theurer Cancer Center At Hackensack University Medical Center|Icahn School Of Medicine At Mount Sinai|Cleveland Clinic|Thomas Jefferson University|Sarah Cannon Research Institute|The University Of Texas, Md Anderson Cancer Center|University Of Utah, Huntsman Cancer Institute|University Of Virginia Health System|Swedish Cancer Institute",{"$nulls":3},"Kite Study Director","2019-08-09","2020-05-25T16:35:21.243","2020-05-26T17:10:42.972","NCT03391466"]
["5ecbf3c9fe30261b1a0481b0","NCT03391466","2019-11-04","Gilead Sciences","GILD","Active, not recruiting","Efficacy of Axicabtagene Ciloleucel Compared to Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma (ZUMA-7)","Axicabtagene ciloleucel|Cyclophosphamide|Fludarabine|Autologous stem cell transplant","CAR-T|Immunomodulator|STAT1 Inhibitor|Autologous Cell Therapy","Yes","['Axicabtagene ciloleucel']","Yes","['CAR-T', 'Autologous Cell Therapy']","Phase 3",2,359,"Actual","2017-12-14","2022-01-15","EFS","Event Free Survival",{"$nulls":3},"The purpose of this study is to evaluate whether axicabtagene ciloleucel therapy improves the clinical outcome compared with standard of care second-line therapy in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL).","This is a phase 3 randomized, open-label, multicenter study evaluating the efficacy of axicabtagene ciloleucel versus standard of care therapy in subjects with relapsed/refractory DLBCL. Adult subjects with relapsed/refractory DLBCL after first-line rituximab and anthracycline-based chemotherapy will be randomized in a 1:1 ratio to receive axicabtagene ciloleucel or standard of care second-line therapy.\n\nStandard of care will consist of a protocol-defined, platinum-based salvage combination chemotherapy regimen followed by high-dose therapy and autologous stem cell transplant in those who respond to salvage chemotherapy.","A Phase 3, Randomized, Open-Label Study Evaluating Efficacy of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma","KTE-C19-107","Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)","Diffuse Large B-Cell Lymphoma|Lymphoma|Lymphoma, B-Cell","Oncology Hematological","Oncology","Experimental|Active Comparator","Axicabtagene Ciloleucel Treatment|Standard of Care Therapy",null,"Biological|Drug","Axicabtagene Ciloleucel|Cyclophosphamide|Fludarabine|Platinum-containing salvage chemotherapy (eg, R-ICE) followed by high dose therapy (eg, BEAM) and autologous stem cell transplant in responders.","A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells administered intravenously following a conditioning chemotherapy regimen of fludarabine and cyclophosphamide|Administered intravenously|Platinum-containing salvage chemotherapy (R-ICE, R-DHAP, R-ESHAP, or R-GDP as selected by treating investigator) followed by high dose therapy (eg, BEAM) and autologous stem cell transplant in responders.","KTE-C19 | axi-cel","Axicabtagene Ciloleucel Treatment|Standard of Care Therapy","\n\n 1. Histologically proven large B-cell lymphoma including the following types defined by WHO 2016 (Swerdlow et al, 2016) * DLBCL not otherwise specified (ABC/GCB)\n     * HGBL with or without MYC and BCL2 and/or BCL6 rearrangement\n     * DLBCL arising from FL\n     * T-cell/histiocyte rich large B-cell lymphoma\n     * DLBCL associated with chronic inflammation\n     * Primary cutaneous DLBCL, leg type\n     * Epstein-Barr virus (EBV) + DLBCL\n    \n    \n 2. Relapsed or refractory disease after first-line chemoimmunotherapy * Refractory disease defined as no complete remission to first-line therapy; individuals who are intolerant to first-line therapy are excluded. * Progressive disease (PD) as best response to first-line therapy\n        * Stable disease (SD) as best response after at least 4 cycles of first-line therapy (eg, 4 cycles of R-CHOP)\n        * Partial response (PR) as best response after at least 6 cycles and biopsy-proven residual disease or disease progression â‰¤ 12 months of therapy\n       \n       \n     * Relapsed disease defined as complete remission to first-line therapy followed by biopsy-proven relapse â‰¤ 12 months of first-line therapy\n    \n    \n 3. Individuals must have received adequate first-line therapy including at a minimum: * Anti-CD20 monoclonal antibody unless investigator determines that tumor is CD20 negative, and\n     * An anthracycline containing chemotherapy regimen\n    \n    \n 4. No known history or suspicion of central nervous system involvement by lymphoma\n 5. Eastern cooperative oncology group (ECOG) performance status of 0 or 1\n 6. Adequate bone marrow function as evidenced by: * Absolute neutrophil count (ANC) â‰¥ 1000/uL\n     * Platelet â‰¥ 75,000/uL\n     * Absolute lymphocyte count â‰¥ 100/uL\n    \n    \n 7. Adequate renal, hepatic, cardiac, and pulmonary function as evidenced by: * Creatinine clearance (Cockcroft Gault) â‰¥ 60 mL/min\n     * Serum Alanine aminotransferase/Aspartate aminotransferase (ALT/AST) â‰¤ 2.5 Upper limit of normal (ULN)\n     * Total bilirubin â‰¤ 1.5 mg/dl\n     * Cardiac ejection fraction â‰¥ 50%, no evidence of pericardial effusion as determined by an Echocardiogram (ECHO), and no clinically significant Electrocardiogram (ECG) findings\n     * No clinically significant pleural effusion\n     * Baseline oxygen saturation > 92% on room air\n    \n    \n\nKey ","\n\n 1.  History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (eg cervix, bladder, breast) unless disease free for at least 3 years\n 2.  Received more than one line of therapy for DLBCL\n 3.  History of autologous or allogeneic stem cell transplant\n 4.  Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring intravenous antimicrobials for management.\n 5.  Known history of infection with human immunodeficiency virus (HIV) or hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive). If there is a positive history of treated hepatitis B or hepatitis C, the viral load must be undetectable per quantitative polymerase chain reaction (PCR) and/or nucleic acid testing.\n 6.  Individuals with detectable cerebrospinal fluid malignant cells or known brain metastases, or with a history of cerebrospinal fluid malignant cells or brain metastases.\n 7.  History or presence of non-malignant central nervous system (CNS) disorder such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement\n 8.  Presence of any indwelling line or drain. Dedicated central venous access catheter such as a Port-a-Cath or Hickman catheter are permitted.\n 9.  History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, New York Heart Association Class II or greater congestive heart failure, or other clinically significant cardiac diseases within 12 months of enrollment\n 10. History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months of enrollment\n 11. History of autoimmune disease, requiring systemic immunosuppression and/or systemic disease modifying agents within the last 2 years\n 12. History of anti-CD19 or CAR-T therapy or history of prior randomization in ZUMA-7\n\nNote: Other protocol defined Inclusion/Exclusion criteria may apply","MYC","MYC proto-oncogene, bHLH transcription factor","Gene","Breast, Lung","Actual","2018-01-05","Actual","Anticipated","2035-01-15","Anticipated","2019-11-01","2017-12-21","2017-12-29","2019-11-01","Yes",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No","Yes","Cheson BD, Fisher RI, Barrington SF, Cavalli F, Schwartz LH, Zucca E, Lister TA; Alliance, Australasian Leukaemia and Lymphoma Group; Eastern Cooperative Oncology Group; European Mantle Cell Lymphoma Consortium; Italian Lymphoma Foundation; European Organisation for Research; Treatment of Cancer/Dutch Hemato-Oncology Group; Grupo EspaÃ±ol de MÃ©dula Ã“sea; German High-Grade Lymphoma Study Group; German Hodgkin's Study Group; Japanese Lymphorra Study Group; Lymphoma Study Association; NCIC Clinical Trials Group; Nordic Lymphoma Study Group; Southwest Oncology Group; United Kingdom National Cancer Research Institute. Recommendations for initial evaluation, staging, and response assessment of Hodgkin and non-Hodgkin lymphoma: the Lugano classification. J Clin Oncol. 2014 Sep 20;32(27):3059-68. PubMed 25113753",null,null,"Yes","No",{"$nulls":17},"2017-002261-22","EudraCT Number","Event Free Survival (EFS)","Event free survival is defined as the time from randomization to the earliest date of disease progression per Lugano Classification (Cheson et al, 2014), commencement of new lymphoma therapy, or death from any cause as determined by blinded central review","Up to 5 years","Objective Response Rate (ORR)|Overall Survival (OS)|Modified Event Free Survival (mEFS)|Progression-Free Survival (PFS)|Duration of Response (DOR)|Percentage of Adverse Events and Clinical Significant Changes in Safety Lab Values, including antibodies to axicabtagene ciloleucel.|Changes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Cancer-30 (EORTC QLQ-C30) domains|Changes over time in the European Quality of Life Five Dimensions Five Levels scale(EQ-5D-5L)|Changes over time in the Visual analog scale (VAS) scores","Objective response rate is defined as the incidence of either a complete response or a partial response by the Lugano Classification (Cheson et al, 2014) as determined by blinded central review|Overall survival is defined as the time from randomization to death from any cause|Event free survival is defined the same way as EFS, except that failure to attain CR or PR by Day 150 assessment is not considered an event. mEFS will be analyzed per blinded central review and per investigator disease assessments.|Progression Free Survival is defined as the time from randomization to disease progression per Lugano Classification (Cheson et al, 2014) or death from any cause|Duration of Response is derived only among subjects who experience an objective response per Lugano Classification (Cheson et al, 2014) as determined by blinded central review and is defined as the time from first response to disease progression per the Lugano Classification or death from any cause|Up to 5 years|The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Cancer-30 (EORTC QLQ-C30) is a multi-item questionnaire measuring the following content five (5) multi-item functional scales, three (3) multi-item symptom scales, one (1) global health status scale, and one (1) global health-related quality of life (HRQoL) each scale is measured from 0 to 100 after a linear transformation. Higher scores for functioning scales and for the Global Health Status or Global HRQoL scales indicate a higher level of functioning and a better HRQoL respectively, whereas higher scores in symptom scales represent a higher level of symptoms.|The Euro-QOL, Five Dimensions, Five Levels (EQ-5D-5L) questionnaire is a generic measure of health status that provides a simple descriptive profile and a single index value. The EQ-5D-5L comprises 2 components: a questionnaire covering 5 dimensions and a tariff of values based upon direct valuations of health states using a visual analog scale (VAS).|The EQ-5D-5L VAS is a 20-cm VAS for recording self-rated current HRQoL state and is used to describe the subjects' health status on the day of the assessment. The EQ-5D-5L VAS score is recorded by each subject for his or her current HRQoL state and scored 0 (\"the worst health you can imagine\") to 100 (\"the best health you can imagine\").","Up to 5 years",{"$nulls":3},"Melbourne, Victoria, Australia, 3000|Graz, Austria, 6020 Medizinische Universitat Innsbruck, Innere Medizin V - Hamatologie Und OnkologieInnsbruck, Austria, 6020|Brussels, Belgium Uz GasthuisbergLeuven, Belgium|Vancouver, British Columbia, Canada|Winnipeg, Manitoba, Canada, R3E 0V9|Toronto, Ontario, Canada, M5G 2M9|Halifax, Canada, B3H 2Y9 Centre Integre Universitaire De Sante Et Services Sociaux De L'Est-De-L'Lle-De-Montreal / Hopital Maisonneuve-RosemontMontrÃ©al, Canada, H1T 2M4 Mcgill University Health CenterMontreal, Canada, H4A 3J1 The Ottawa Hospital - General CampusOttawa, Canada, K1H 8L6 Chu De Quebec-Universite Laval, Hopital De L'Enfante-JesusQuÃ©bec, Canada, G1J 1Z4|Lille Cedex, France, 59037 Centre Hospitalier Universataire De NantesNantes, France, 44000 Hopital Saint-LouisParis, France, 75475 Centre Hospitalier Lyon-Sud - Service D'Hematologie CliniquePierre Benite, France, 69495 Centre Hospitalier Universitaire De Rennes - Hopital PontchaillouRennes, France, 35033|Dresden, Germany, 01307 Universitatsmedizin GottingenGÃ¶ttingen, Germany, 37075 Universitatsklinikum Hamburg-EppendorfHamburg, Germany, 20246 UniversitÃ¤tsklinikum HeidelbergHeidelberg, Germany, 69120 Universitatsklinikum MunsterMÃ¼nster, Germany, 48149 UniversitÃ¤ts-Klinikum WÃ¼rzburgWÃ¼rzburg, Germany, 97080|Tel Aviv, Israel, 62431|Bologna, Italy, 40138 Irccs Ospedale San Raffaele Di MilanoMilano, Italy, 20132|Amsterdam, Netherlands, 1105 Az University Medical Center GroningenGroningen, Netherlands, 9700 Rb Erasmus Medical CenterRotterdam, Netherlands, 3011Pl University Medical Center UtrechtUtrecht, Netherlands|Barcelona, Spain, 08036 Institut Catala D'OncologiaBarcelona, Spain, 08908 Hospital Universitario La PazMadrid, Spain, 28046 Clinica Universidad De NavarraPamplona, Spain, 31008 Hospital Universitario De SalamancaSalamanca, Spain, 37007|Lund, Sweden, Se 221 85 Uppsala Akademiska SjukhusUppsala, Sweden, 75185|Bellinzona, Switzerland, 6500 Centre Hospitalier Universitaire Vaudois (Chuv)Lausanne, Switzerland, 1011 University Hospital ZurichZÃ¼rich, Switzerland, 8091|Birmingham, United Kingdom, B15 2Gw Barts Health Nhs TrustLondon, United Kingdom, Ec1A 7Be University College London Hospitals Nhs Foundation TrustLondon, United Kingdom, Nw3 2Qg The Christie Nhs Foundation TrustManchester, United Kingdom, M20 4Bx The Royal Marsden Nhs Foundation TrustSutton, United Kingdom, Sm2 5Pt|Birmingham, Alabama, United States, 35233|Gilbert, Arizona, United States, 85234 Mayo Clinic HospitalPhoenix, Arizona, United States, 85054|San Diego, California, United States, 92093-0698 UclaSanta Monica, California, United States, 90404 Stanford Cancer InstituteStanford, California, United States, 94305|Miami, Florida, United States, 33136 Moffitt Cancer CenterTampa, Florida, United States, 12902|Chicago, Illinois, United States, 60612 University Of Chicago Medical CenterChicago, Illinois, United States, 60637|Iowa City, Iowa, United States, 52242|Kansas City, Kansas, United States, 66160|Baltimore, Maryland, United States, 21201|Boston, Massachusetts, United States, 02215|Detroit, Michigan, United States, 48201|Rochester, Minnesota, United States, 55905|Saint Louis, Missouri, United States, 63130|Hackensack, New Jersey, United States, 07601|New York, New York, United States, 10029 Memorial Sloan Kettering Cancer CenterNew York, New York, United States, 10065 University Of Rochester Medical CenterRochester, New York, United States, 14642|Cleveland, Ohio, United States, 44195 James Cancer Hospital And Solove Research Institute At The Ohio State University Comprehensive Cancer CenterColumbus, Ohio, United States, 43210|Philadelphia, Pennsylvania, United States, 19107 Upmc Hillman Cancer CenterPittsburgh, Pennsylvania, United States, 15213|Nashville, Tennessee, United States, 37203 Henry-Joyce Cancer CenterNashville, Tennessee, United States, 37232|Houston, Texas, United States, 77030|Salt Lake City, Utah, United States, 84112|Charlottesville, Virginia, United States, 22908|Seattle, Washington, United States, 98104","Alabama|Arizona|California|Florida|Illinois|Iowa|Kansas|Maryland|Massachusetts|Michigan|Minnesota|Missouri|New Jersey|New York|Ohio|Pennsylvania|Tennessee|Texas|Utah|Virginia|Washington","Australia|Austria|Belgium|Canada|France|Germany|Israel|Italy|Netherlands|Spain|Sweden|Switzerland|United Kingdom|United States","Victoria Peter Maccallum Cancer Center|Universitatsklinikum Graz, Division Of Hematology|Cliniques Universiaires Saint-Luc|British Columbia Vancouver General Hospital|Manitoba Cancercare Manitoba|Ontario Uninversity Health Network - Princess Margaret Cancer Center|Qeii Health Sciences Centre|Chru De Lille - Hopital Claude Huriez|UniversitÃ¤ts-Klinikum Dresden|Tel Aviv Sourasky Medical Center|Instituto Di Ematologia \"L. E A. Seragnoli\" - Dipartimento Di Medicina Specialistica Diagnostica E Sperimentale|Academic Medical Center|Hospital Clinic De Barcelona|Skane University Hospital|Iosi, Ospedale Regionale Bellinzona E Valli|University Hospitals Birmingham Nhs Foundation Trust|University Of Alabama At Birmingham|Banner Md Anderson Cancer Center|Uc San Diego Moores Cancer Center|University Of Miami Hospital And Clinics/Sylvester Comprehensive Cancer Center|Northwestern University|University Of Iowa Hospitals And Clinincs|The University Of Kansas Cancer Center|University Of Maryland, Greenbaum Comprehensive Cancer Center|Dana-Farber Cancer Institute|Barbara Ann Karmanos Cancer Institute|Mayo Clinic, Patient Location|Washington University School Of Medicine|John Theurer Cancer Center At Hackensack University Medical Center|Icahn School Of Medicine At Mount Sinai|Cleveland Clinic|Thomas Jefferson University|Sarah Cannon Research Institute|The University Of Texas, Md Anderson Cancer Center|University Of Utah, Huntsman Cancer Institute|University Of Virginia Health System|Swedish Cancer Institute",{"$nulls":3},"Kite Study Director","2019-11-01","2020-05-25T16:35:21.405","2020-05-26T17:10:42.972","NCT03391466"]
["5ecbf3c9307e3d1b1f8d9c41","NCT03391466","2019-12-09","Gilead Sciences","GILD","Active, not recruiting","Efficacy of Axicabtagene Ciloleucel Compared to Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma (ZUMA-7)","Axicabtagene ciloleucel|Cyclophosphamide|Fludarabine|Autologous stem cell transplant","CAR-T|Immunomodulator|STAT1 Inhibitor|Autologous Cell Therapy","Yes","['Axicabtagene ciloleucel']","Yes","['CAR-T', 'Autologous Cell Therapy']","Phase 3",2,359,"Actual","2017-12-14","2022-01-15","EFS","Event Free Survival",{"$nulls":3},"The purpose of this study is to evaluate whether axicabtagene ciloleucel therapy improves the clinical outcome compared with standard of care second-line therapy in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL).","This is a phase 3 randomized, open-label, multicenter study evaluating the efficacy of axicabtagene ciloleucel versus standard of care therapy in subjects with relapsed/refractory DLBCL. Adult subjects with relapsed/refractory DLBCL after first-line rituximab and anthracycline-based chemotherapy will be randomized in a 1:1 ratio to receive axicabtagene ciloleucel or standard of care second-line therapy.\n\nStandard of care will consist of a protocol-defined, platinum-based salvage combination chemotherapy regimen followed by high-dose therapy and autologous stem cell transplant in those who respond to salvage chemotherapy.","A Phase 3, Randomized, Open-Label Study Evaluating Efficacy of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma","KTE-C19-107","Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)","Diffuse Large B-Cell Lymphoma|Lymphoma|Lymphoma, B-Cell","Oncology Hematological","Oncology","Experimental|Active Comparator","Axicabtagene Ciloleucel Treatment|Standard of Care Therapy",null,"Biological|Drug","Axicabtagene Ciloleucel|Cyclophosphamide|Fludarabine|Platinum-containing salvage chemotherapy (eg, R-ICE) followed by high dose therapy (eg, BEAM) and autologous stem cell transplant in responders.","A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells administered intravenously following a conditioning chemotherapy regimen of fludarabine and cyclophosphamide|Administered intravenously|Platinum-containing salvage chemotherapy (R-ICE, R-DHAP, R-ESHAP, or R-GDP as selected by treating investigator) followed by high dose therapy (eg, BEAM) and autologous stem cell transplant in responders.","KTE-C19 | axi-cel","Axicabtagene Ciloleucel Treatment|Standard of Care Therapy","\n\n 1. Histologically proven large B-cell lymphoma including the following types defined by WHO 2016 (Swerdlow et al, 2016) * DLBCL not otherwise specified (ABC/GCB)\n     * HGBL with or without MYC and BCL2 and/or BCL6 rearrangement\n     * DLBCL arising from FL\n     * T-cell/histiocyte rich large B-cell lymphoma\n     * DLBCL associated with chronic inflammation\n     * Primary cutaneous DLBCL, leg type\n     * Epstein-Barr virus (EBV) + DLBCL\n    \n    \n 2. Relapsed or refractory disease after first-line chemoimmunotherapy * Refractory disease defined as no complete remission to first-line therapy; individuals who are intolerant to first-line therapy are excluded. * Progressive disease (PD) as best response to first-line therapy\n        * Stable disease (SD) as best response after at least 4 cycles of first-line therapy (eg, 4 cycles of R-CHOP)\n        * Partial response (PR) as best response after at least 6 cycles and biopsy-proven residual disease or disease progression â‰¤ 12 months of therapy\n       \n       \n     * Relapsed disease defined as complete remission to first-line therapy followed by biopsy-proven relapse â‰¤ 12 months of first-line therapy\n    \n    \n 3. Individuals must have received adequate first-line therapy including at a minimum: * Anti-CD20 monoclonal antibody unless investigator determines that tumor is CD20 negative, and\n     * An anthracycline containing chemotherapy regimen\n    \n    \n 4. No known history or suspicion of central nervous system involvement by lymphoma\n 5. Eastern cooperative oncology group (ECOG) performance status of 0 or 1\n 6. Adequate bone marrow function as evidenced by: * Absolute neutrophil count (ANC) â‰¥ 1000/uL\n     * Platelet â‰¥ 75,000/uL\n     * Absolute lymphocyte count â‰¥ 100/uL\n    \n    \n 7. Adequate renal, hepatic, cardiac, and pulmonary function as evidenced by: * Creatinine clearance (Cockcroft Gault) â‰¥ 60 mL/min\n     * Serum Alanine aminotransferase/Aspartate aminotransferase (ALT/AST) â‰¤ 2.5 Upper limit of normal (ULN)\n     * Total bilirubin â‰¤ 1.5 mg/dl\n     * Cardiac ejection fraction â‰¥ 50%, no evidence of pericardial effusion as determined by an Echocardiogram (ECHO), and no clinically significant Electrocardiogram (ECG) findings\n     * No clinically significant pleural effusion\n     * Baseline oxygen saturation > 92% on room air\n    \n    \n\nKey ","\n\n 1.  History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (eg cervix, bladder, breast) unless disease free for at least 3 years\n 2.  Received more than one line of therapy for DLBCL\n 3.  History of autologous or allogeneic stem cell transplant\n 4.  Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring intravenous antimicrobials for management.\n 5.  Known history of infection with human immunodeficiency virus (HIV) or hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive). If there is a positive history of treated hepatitis B or hepatitis C, the viral load must be undetectable per quantitative polymerase chain reaction (PCR) and/or nucleic acid testing.\n 6.  Individuals with detectable cerebrospinal fluid malignant cells or known brain metastases, or with a history of cerebrospinal fluid malignant cells or brain metastases.\n 7.  History or presence of non-malignant central nervous system (CNS) disorder such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement\n 8.  Presence of any indwelling line or drain. Dedicated central venous access catheter such as a Port-a-Cath or Hickman catheter are permitted.\n 9.  History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, New York Heart Association Class II or greater congestive heart failure, or other clinically significant cardiac diseases within 12 months of enrollment\n 10. History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months of enrollment\n 11. History of autoimmune disease, requiring systemic immunosuppression and/or systemic disease modifying agents within the last 2 years\n 12. History of anti-CD19 or CAR-T therapy or history of prior randomization in ZUMA-7\n\nNote: Other protocol defined Inclusion/Exclusion criteria may apply","MYC","MYC proto-oncogene, bHLH transcription factor","Gene","Breast, Lung","Actual","2018-01-05","Actual","Anticipated","2035-01-15","Anticipated","2019-12-01","2017-12-21","2017-12-29","2019-12-06","Yes",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No","Yes","Cheson BD, Fisher RI, Barrington SF, Cavalli F, Schwartz LH, Zucca E, Lister TA; Alliance, Australasian Leukaemia and Lymphoma Group; Eastern Cooperative Oncology Group; European Mantle Cell Lymphoma Consortium; Italian Lymphoma Foundation; European Organisation for Research; Treatment of Cancer/Dutch Hemato-Oncology Group; Grupo EspaÃ±ol de MÃ©dula Ã“sea; German High-Grade Lymphoma Study Group; German Hodgkin's Study Group; Japanese Lymphorra Study Group; Lymphoma Study Association; NCIC Clinical Trials Group; Nordic Lymphoma Study Group; Southwest Oncology Group; United Kingdom National Cancer Research Institute. Recommendations for initial evaluation, staging, and response assessment of Hodgkin and non-Hodgkin lymphoma: the Lugano classification. J Clin Oncol. 2014 Sep 20;32(27):3059-68. PubMed 25113753",null,null,"Yes","No",{"$nulls":17},"2017-002261-22","EudraCT Number","Event Free Survival (EFS)","Event free survival is defined as the time from randomization to the earliest date of disease progression per Lugano Classification (Cheson et al, 2014), commencement of new lymphoma therapy, or death from any cause as determined by blinded central review","Up to 5 years","Objective Response Rate (ORR)|Overall Survival (OS)|Modified Event Free Survival (mEFS)|Progression-Free Survival (PFS)|Duration of Response (DOR)|Percentage of Adverse Events and Clinical Significant Changes in Safety Lab Values, including antibodies to axicabtagene ciloleucel.|Changes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Cancer-30 (EORTC QLQ-C30) domains|Changes over time in the European Quality of Life Five Dimensions Five Levels scale(EQ-5D-5L)|Changes over time in the Visual analog scale (VAS) scores","Objective response rate is defined as the incidence of either a complete response or a partial response by the Lugano Classification (Cheson et al, 2014) as determined by blinded central review|Overall survival is defined as the time from randomization to death from any cause|Event free survival is defined the same way as EFS, except that failure to attain CR or PR by Day 150 assessment is not considered an event. mEFS will be analyzed per blinded central review and per investigator disease assessments.|Progression Free Survival is defined as the time from randomization to disease progression per Lugano Classification (Cheson et al, 2014) or death from any cause|Duration of Response is derived only among subjects who experience an objective response per Lugano Classification (Cheson et al, 2014) as determined by blinded central review and is defined as the time from first response to disease progression per the Lugano Classification or death from any cause|Up to 5 years|The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Cancer-30 (EORTC QLQ-C30) is a multi-item questionnaire measuring the following content five (5) multi-item functional scales, three (3) multi-item symptom scales, one (1) global health status scale, and one (1) global health-related quality of life (HRQoL) each scale is measured from 0 to 100 after a linear transformation. Higher scores for functioning scales and for the Global Health Status or Global HRQoL scales indicate a higher level of functioning and a better HRQoL respectively, whereas higher scores in symptom scales represent a higher level of symptoms.|The Euro-QOL, Five Dimensions, Five Levels (EQ-5D-5L) questionnaire is a generic measure of health status that provides a simple descriptive profile and a single index value. The EQ-5D-5L comprises 2 components: a questionnaire covering 5 dimensions and a tariff of values based upon direct valuations of health states using a visual analog scale (VAS).|The EQ-5D-5L VAS is a 20-cm VAS for recording self-rated current HRQoL state and is used to describe the subjects' health status on the day of the assessment. The EQ-5D-5L VAS score is recorded by each subject for his or her current HRQoL state and scored 0 (\"the worst health you can imagine\") to 100 (\"the best health you can imagine\").","Up to 5 years",{"$nulls":3},"Melbourne, Victoria, Australia, 3000|Graz, Austria, 6020 Medizinische Universitat Innsbruck, Innere Medizin V - Hamatologie Und OnkologieInnsbruck, Austria, 6020|Brussels, Belgium Uz GasthuisbergLeuven, Belgium|Vancouver, British Columbia, Canada|Winnipeg, Manitoba, Canada, R3E 0V9|Toronto, Ontario, Canada, M5G 2M9|Halifax, Canada, B3H 2Y9 Centre Integre Universitaire De Sante Et Services Sociaux De L'Est-De-L'Lle-De-Montreal / Hopital Maisonneuve-RosemontMontrÃ©al, Canada, H1T 2M4 Mcgill University Health CenterMontreal, Canada, H4A 3J1 The Ottawa Hospital - General CampusOttawa, Canada, K1H 8L6 Chu De Quebec-Universite Laval, Hopital De L'Enfante-JesusQuÃ©bec, Canada, G1J 1Z4|Lille Cedex, France, 59037 Centre Hospitalier Universataire De NantesNantes, France, 44000 Hopital Saint-LouisParis, France, 75475 Centre Hospitalier Lyon-Sud - Service D'Hematologie CliniquePierre Benite, France, 69495 Centre Hospitalier Universitaire De Rennes - Hopital PontchaillouRennes, France, 35033|Dresden, Germany, 01307 Universitatsmedizin GottingenGÃ¶ttingen, Germany, 37075 Universitatsklinikum Hamburg-EppendorfHamburg, Germany, 20246 UniversitÃ¤tsklinikum HeidelbergHeidelberg, Germany, 69120 Universitatsklinikum MunsterMÃ¼nster, Germany, 48149 UniversitÃ¤ts-Klinikum WÃ¼rzburgWÃ¼rzburg, Germany, 97080|Tel Aviv, Israel, 62431|Bologna, Italy, 40138 Irccs Ospedale San Raffaele Di MilanoMilano, Italy, 20132|Amsterdam, Netherlands, 1105 Az University Medical Center GroningenGroningen, Netherlands, 9700 Rb Erasmus Medical CenterRotterdam, Netherlands, 3011Pl University Medical Center UtrechtUtrecht, Netherlands|Barcelona, Spain, 08036 Institut Catala D'OncologiaBarcelona, Spain, 08908 Hospital Universitario La PazMadrid, Spain, 28046 Clinica Universidad De NavarraPamplona, Spain, 31008 Hospital Universitario De SalamancaSalamanca, Spain, 37007|Lund, Sweden, Se 221 85 Uppsala Akademiska SjukhusUppsala, Sweden, 75185|Bellinzona, Switzerland, 6500 Centre Hospitalier Universitaire Vaudois (Chuv)Lausanne, Switzerland, 1011 University Hospital ZurichZÃ¼rich, Switzerland, 8091|Birmingham, United Kingdom, B15 2Gw Barts Health Nhs TrustLondon, United Kingdom, Ec1A 7Be University College London Hospitals Nhs Foundation TrustLondon, United Kingdom, Nw3 2Qg The Christie Nhs Foundation TrustManchester, United Kingdom, M20 4Bx The Royal Marsden Nhs Foundation TrustSutton, United Kingdom, Sm2 5Pt|Birmingham, Alabama, United States, 35233|Gilbert, Arizona, United States, 85234 Mayo Clinic HospitalPhoenix, Arizona, United States, 85054|San Diego, California, United States, 92093-0698 UclaSanta Monica, California, United States, 90404 Stanford Cancer InstituteStanford, California, United States, 94305|Miami, Florida, United States, 33136 Moffitt Cancer CenterTampa, Florida, United States, 12902|Chicago, Illinois, United States, 60612 University Of Chicago Medical CenterChicago, Illinois, United States, 60637|Iowa City, Iowa, United States, 52242|Kansas City, Kansas, United States, 66160|Baltimore, Maryland, United States, 21201|Boston, Massachusetts, United States, 02215|Detroit, Michigan, United States, 48201|Rochester, Minnesota, United States, 55905|Saint Louis, Missouri, United States, 63130|Hackensack, New Jersey, United States, 07601|New York, New York, United States, 10029 Memorial Sloan Kettering Cancer CenterNew York, New York, United States, 10065 University Of Rochester Medical CenterRochester, New York, United States, 14642|Cleveland, Ohio, United States, 44195 James Cancer Hospital And Solove Research Institute At The Ohio State University Comprehensive Cancer CenterColumbus, Ohio, United States, 43210|Philadelphia, Pennsylvania, United States, 19107 Upmc Hillman Cancer CenterPittsburgh, Pennsylvania, United States, 15213|Nashville, Tennessee, United States, 37203 Henry-Joyce Cancer CenterNashville, Tennessee, United States, 37232|Houston, Texas, United States, 77030|Salt Lake City, Utah, United States, 84112|Charlottesville, Virginia, United States, 22908|Seattle, Washington, United States, 98104","Alabama|Arizona|California|Florida|Illinois|Iowa|Kansas|Maryland|Massachusetts|Michigan|Minnesota|Missouri|New Jersey|New York|Ohio|Pennsylvania|Tennessee|Texas|Utah|Virginia|Washington","Australia|Austria|Belgium|Canada|France|Germany|Israel|Italy|Netherlands|Spain|Sweden|Switzerland|United Kingdom|United States","Victoria Peter Maccallum Cancer Center|Universitatsklinikum Graz, Division Of Hematology|Cliniques Universiaires Saint-Luc|British Columbia Vancouver General Hospital|Manitoba Cancercare Manitoba|Ontario Uninversity Health Network - Princess Margaret Cancer Center|Qeii Health Sciences Centre|Chru De Lille - Hopital Claude Huriez|UniversitÃ¤ts-Klinikum Dresden|Tel Aviv Sourasky Medical Center|Instituto Di Ematologia \"L. E A. Seragnoli\" - Dipartimento Di Medicina Specialistica Diagnostica E Sperimentale|Academic Medical Center|Hospital Clinic De Barcelona|Skane University Hospital|Iosi, Ospedale Regionale Bellinzona E Valli|University Hospitals Birmingham Nhs Foundation Trust|University Of Alabama At Birmingham|Banner Md Anderson Cancer Center|Uc San Diego Moores Cancer Center|University Of Miami Hospital And Clinics/Sylvester Comprehensive Cancer Center|Northwestern University|University Of Iowa Hospitals And Clinincs|The University Of Kansas Cancer Center|University Of Maryland, Greenbaum Comprehensive Cancer Center|Dana-Farber Cancer Institute|Barbara Ann Karmanos Cancer Institute|Mayo Clinic, Patient Location|Washington University School Of Medicine|John Theurer Cancer Center At Hackensack University Medical Center|Icahn School Of Medicine At Mount Sinai|Cleveland Clinic|Thomas Jefferson University|Sarah Cannon Research Institute|The University Of Texas, Md Anderson Cancer Center|University Of Utah, Huntsman Cancer Institute|University Of Virginia Health System|Swedish Cancer Institute",{"$nulls":3},"Kite Study Director","2019-12-06","2020-05-25T16:35:21.781","2020-05-26T17:10:42.972","NCT03391466"]
["5ecbf3c9e2561b1b11905cac","NCT03391466","2020-04-07","Gilead Sciences","GILD","Active, not recruiting","Efficacy of Axicabtagene Ciloleucel Compared to Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma (ZUMA-7)","Axicabtagene ciloleucel|Cyclophosphamide|Fludarabine|Autologous stem cell transplant","CAR-T|Immunomodulator|STAT1 Inhibitor|Autologous Cell Therapy","Yes","['Axicabtagene ciloleucel']","Yes","['CAR-T', 'Autologous Cell Therapy']","Phase 3",2,359,"Actual","2017-12-14","2022-01-15","EFS","Event Free Survival",{"$nulls":3},"The purpose of this study is to evaluate whether axicabtagene ciloleucel therapy improves the clinical outcome compared with standard of care second-line therapy in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL).","This is a phase 3 randomized, open-label, multicenter study evaluating the efficacy of axicabtagene ciloleucel versus standard of care therapy in subjects with relapsed/refractory DLBCL. Adult subjects with relapsed/refractory DLBCL after first-line rituximab and anthracycline-based chemotherapy will be randomized in a 1:1 ratio to receive axicabtagene ciloleucel or standard of care second-line therapy.\n\nStandard of care will consist of a protocol-defined, platinum-based salvage combination chemotherapy regimen followed by high-dose therapy and autologous stem cell transplant in those who respond to salvage chemotherapy.","A Phase 3, Randomized, Open-Label Study Evaluating Efficacy of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma","KTE-C19-107","Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)","Diffuse Large B-Cell Lymphoma|Lymphoma|Lymphoma, B-Cell","Oncology Hematological","Oncology","Experimental|Active Comparator","Axicabtagene Ciloleucel Treatment|Standard of Care Therapy",null,"Biological|Drug","Axicabtagene Ciloleucel|Cyclophosphamide|Fludarabine|Platinum-containing salvage chemotherapy (eg, R-ICE) followed by high dose therapy (eg, BEAM) and autologous stem cell transplant in responders.","A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells administered intravenously following a conditioning chemotherapy regimen of fludarabine and cyclophosphamide|Administered intravenously|Platinum-containing salvage chemotherapy (R-ICE, R-DHAP, R-ESHAP, or R-GDP as selected by treating investigator) followed by high dose therapy (eg, BEAM) and autologous stem cell transplant in responders.","KTE-C19 | axi-cel","Axicabtagene Ciloleucel Treatment|Standard of Care Therapy","\n\n 1. Histologically proven large B-cell lymphoma including the following types defined by WHO 2016 (Swerdlow et al, 2016) * DLBCL not otherwise specified (ABC/GCB)\n     * HGBL with or without MYC and BCL2 and/or BCL6 rearrangement\n     * DLBCL arising from FL\n     * T-cell/histiocyte rich large B-cell lymphoma\n     * DLBCL associated with chronic inflammation\n     * Primary cutaneous DLBCL, leg type\n     * Epstein-Barr virus (EBV) + DLBCL\n    \n    \n 2. Relapsed or refractory disease after first-line chemoimmunotherapy * Refractory disease defined as no complete remission to first-line therapy; individuals who are intolerant to first-line therapy are excluded. * Progressive disease (PD) as best response to first-line therapy\n        * Stable disease (SD) as best response after at least 4 cycles of first-line therapy (eg, 4 cycles of R-CHOP)\n        * Partial response (PR) as best response after at least 6 cycles and biopsy-proven residual disease or disease progression â‰¤ 12 months of therapy\n       \n       \n     * Relapsed disease defined as complete remission to first-line therapy followed by biopsy-proven relapse â‰¤ 12 months of first-line therapy\n    \n    \n 3. Individuals must have received adequate first-line therapy including at a minimum: * Anti-CD20 monoclonal antibody unless investigator determines that tumor is CD20 negative, and\n     * An anthracycline containing chemotherapy regimen\n    \n    \n 4. No known history or suspicion of central nervous system involvement by lymphoma\n 5. Eastern cooperative oncology group (ECOG) performance status of 0 or 1\n 6. Adequate bone marrow function as evidenced by: * Absolute neutrophil count (ANC) â‰¥ 1000/uL\n     * Platelet â‰¥ 75,000/uL\n     * Absolute lymphocyte count â‰¥ 100/uL\n    \n    \n 7. Adequate renal, hepatic, cardiac, and pulmonary function as evidenced by: * Creatinine clearance (Cockcroft Gault) â‰¥ 60 mL/min\n     * Serum Alanine aminotransferase/Aspartate aminotransferase (ALT/AST) â‰¤ 2.5 Upper limit of normal (ULN)\n     * Total bilirubin â‰¤ 1.5 mg/dl\n     * Cardiac ejection fraction â‰¥ 50%, no evidence of pericardial effusion as determined by an Echocardiogram (ECHO), and no clinically significant Electrocardiogram (ECG) findings\n     * No clinically significant pleural effusion\n     * Baseline oxygen saturation > 92% on room air\n    \n    \n\nKey ","\n\n 1.  History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (eg cervix, bladder, breast) unless disease free for at least 3 years\n 2.  Received more than one line of therapy for DLBCL\n 3.  History of autologous or allogeneic stem cell transplant\n 4.  Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring intravenous antimicrobials for management.\n 5.  Known history of infection with human immunodeficiency virus (HIV) or hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive). If there is a positive history of treated hepatitis B or hepatitis C, the viral load must be undetectable per quantitative polymerase chain reaction (PCR) and/or nucleic acid testing.\n 6.  Individuals with detectable cerebrospinal fluid malignant cells or known brain metastases, or with a history of cerebrospinal fluid malignant cells or brain metastases.\n 7.  History or presence of non-malignant central nervous system (CNS) disorder such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement\n 8.  Presence of any indwelling line or drain. Dedicated central venous access catheter such as a Port-a-Cath or Hickman catheter are permitted.\n 9.  History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, New York Heart Association Class II or greater congestive heart failure, or other clinically significant cardiac diseases within 12 months of enrollment\n 10. History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months of enrollment\n 11. History of autoimmune disease, requiring systemic immunosuppression and/or systemic disease modifying agents within the last 2 years\n 12. History of anti-CD19 or CAR-T therapy or history of prior randomization in ZUMA-7\n\nNote: Other protocol defined Inclusion/Exclusion criteria may apply","MYC","MYC proto-oncogene, bHLH transcription factor","Gene","Breast, Lung","Actual","2018-01-05","Actual","Anticipated","2035-01-15","Anticipated","2020-04-01","2017-12-21","2017-12-29","2020-04-06","Yes",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No","Yes","Cheson BD, Fisher RI, Barrington SF, Cavalli F, Schwartz LH, Zucca E, Lister TA; Alliance, Australasian Leukaemia and Lymphoma Group; Eastern Cooperative Oncology Group; European Mantle Cell Lymphoma Consortium; Italian Lymphoma Foundation; European Organisation for Research; Treatment of Cancer/Dutch Hemato-Oncology Group; Grupo EspaÃ±ol de MÃ©dula Ã“sea; German High-Grade Lymphoma Study Group; German Hodgkin's Study Group; Japanese Lymphorra Study Group; Lymphoma Study Association; NCIC Clinical Trials Group; Nordic Lymphoma Study Group; Southwest Oncology Group; United Kingdom National Cancer Research Institute. Recommendations for initial evaluation, staging, and response assessment of Hodgkin and non-Hodgkin lymphoma: the Lugano classification. J Clin Oncol. 2014 Sep 20;32(27):3059-68. PubMed 25113753",null,null,"Yes","No",{"$nulls":17},"2017-002261-22","EudraCT Number","Event Free Survival (EFS)","Event free survival is defined as the time from randomization to the earliest date of disease progression per Lugano Classification (Cheson et al, 2014), commencement of new lymphoma therapy, or death from any cause as determined by blinded central review","Up to 5 years","Objective Response Rate (ORR)|Overall Survival (OS)|Modified Event Free Survival (mEFS)|Progression-Free Survival (PFS)|Duration of Response (DOR)|Percentage of Adverse Events and Clinical Significant Changes in Safety Lab Values, including antibodies to axicabtagene ciloleucel.|Changes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Cancer-30 (EORTC QLQ-C30) domains|Changes over time in the European Quality of Life Five Dimensions Five Levels scale(EQ-5D-5L)|Changes over time in the Visual analog scale (VAS) scores","Objective response rate is defined as the incidence of either a complete response or a partial response by the Lugano Classification (Cheson et al, 2014) as determined by blinded central review|Overall survival is defined as the time from randomization to death from any cause|Event free survival is defined the same way as EFS, except that failure to attain CR or PR by Day 150 assessment is not considered an event. mEFS will be analyzed per blinded central review and per investigator disease assessments.|Progression Free Survival is defined as the time from randomization to disease progression per Lugano Classification (Cheson et al, 2014) or death from any cause|Duration of Response is derived only among subjects who experience an objective response per Lugano Classification (Cheson et al, 2014) as determined by blinded central review and is defined as the time from first response to disease progression per the Lugano Classification or death from any cause|Up to 5 years|The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Cancer-30 (EORTC QLQ-C30) is a multi-item questionnaire measuring the following content five (5) multi-item functional scales, three (3) multi-item symptom scales, one (1) global health status scale, and one (1) global health-related quality of life (HRQoL) each scale is measured from 0 to 100 after a linear transformation. Higher scores for functioning scales and for the Global Health Status or Global HRQoL scales indicate a higher level of functioning and a better HRQoL respectively, whereas higher scores in symptom scales represent a higher level of symptoms.|The Euro-QOL, Five Dimensions, Five Levels (EQ-5D-5L) questionnaire is a generic measure of health status that provides a simple descriptive profile and a single index value. The EQ-5D-5L comprises 2 components: a questionnaire covering 5 dimensions and a tariff of values based upon direct valuations of health states using a visual analog scale (VAS).|The EQ-5D-5L VAS is a 20-cm VAS for recording self-rated current HRQoL state and is used to describe the subjects' health status on the day of the assessment. The EQ-5D-5L VAS score is recorded by each subject for his or her current HRQoL state and scored 0 (\"the worst health you can imagine\") to 100 (\"the best health you can imagine\").","Up to 5 years",{"$nulls":3},"Melbourne, Victoria, Australia, 3000|Graz, Austria, 6020 Medizinische Universitat Innsbruck, Innere Medizin V - Hamatologie Und OnkologieInnsbruck, Austria, 6020|Brussels, Belgium Uz GasthuisbergLeuven, Belgium|Vancouver, British Columbia, Canada|Winnipeg, Manitoba, Canada, R3E 0V9|Toronto, Ontario, Canada, M5G 2M9|Halifax, Canada, B3H 2Y9 Centre Integre Universitaire De Sante Et Services Sociaux De L'Est-De-L'Lle-De-Montreal / Hopital Maisonneuve-RosemontMontrÃ©al, Canada, H1T 2M4 The Ottawa Hospital - General CampusOttawa, Canada, K1H 8L6 Chu De Quebec-Universite Laval, Hopital De L'Enfante-JesusQuÃ©bec, Canada, G1J 1Z4|Montreal, Quebec, Canada, H4A 3J1|Lille Cedex, France, 59037 Centre Hospitalier Universataire De NantesNantes, France, 44000 Hopital Saint-LouisParis, France, 75475 Centre Hospitalier Lyon-Sud - Service D'Hematologie CliniquePierre Benite, France, 69495 Centre Hospitalier Universitaire De Rennes - Hopital PontchaillouRennes, France, 35033|Dresden, Germany, 01307 Universitatsmedizin GottingenGÃ¶ttingen, Germany, 37075 Universitatsklinikum Hamburg-EppendorfHamburg, Germany, 20246 UniversitÃ¤tsklinikum HeidelbergHeidelberg, Germany, 69120 Universitatsklinikum MunsterMÃ¼nster, Germany, 48149 UniversitÃ¤ts-Klinikum WÃ¼rzburgWÃ¼rzburg, Germany, 97080|Tel Aviv, Israel, 6423906|Bologna, Italy, 40138 Irccs Ospedale San Raffaele Di MilanoMilano, Italy, 20132|Amsterdam, Netherlands, 1105 Az University Medical Center GroningenGroningen, Netherlands, 9700 Rb Erasmus Medical CenterRotterdam, Netherlands, 3011Pl University Medical Center UtrechtUtrecht, Netherlands|Barcelona, Spain, 08036 Institut Catala D'OncologiaBarcelona, Spain, 08908 Hospital Universitario La PazMadrid, Spain, 28046 Clinica Universidad De NavarraPamplona, Spain, 31008 Hospital Universitario De SalamancaSalamanca, Spain, 37007|Lund, Sweden, Se 221 85 Uppsala Akademiska SjukhusUppsala, Sweden, 75185|Bellinzona, Switzerland, 6500 Centre Hospitalier Universitaire Vaudois (Chuv)Lausanne, Switzerland, 1011 University Hospital ZurichZÃ¼rich, Switzerland, 8091|Birmingham, United Kingdom, B15 2Gw Barts Health Nhs TrustLondon, United Kingdom, Ec1A 7Be University College London Hospitals Nhs Foundation TrustLondon, United Kingdom, Nw3 2Qg The Christie Nhs Foundation TrustManchester, United Kingdom, M20 4Bx The Royal Marsden Nhs Foundation TrustSutton, United Kingdom, Sm2 5Pt|Birmingham, Alabama, United States, 35233|Gilbert, Arizona, United States, 85234 Mayo Clinic HospitalPhoenix, Arizona, United States, 85054|La Jolla, California, United States, 92093 UclaSanta Monica, California, United States, 90404 Stanford Cancer InstituteStanford, California, United States, 94305|Miami, Florida, United States, 33136 Moffitt Cancer CenterTampa, Florida, United States, 12902|Chicago, Illinois, United States, 60612 University Of Chicago Medical CenterChicago, Illinois, United States, 60637|Iowa City, Iowa, United States, 52242|Kansas City, Kansas, United States, 66160|Baltimore, Maryland, United States, 21201|Boston, Massachusetts, United States, 02215|Detroit, Michigan, United States, 48201|Rochester, Minnesota, United States, 55905|Saint Louis, Missouri, United States, 63130|Hackensack, New Jersey, United States, 07601|New York, New York, United States, 10021 Icahn School Of Medicine At Mount SinaiNew York, New York, United States, 10029 University Of Rochester Medical CenterRochester, New York, United States, 14642|Cleveland, Ohio, United States, 44195 James Cancer Hospital And Solove Research Institute At The Ohio State University Comprehensive Cancer CenterColumbus, Ohio, United States, 43210|Philadelphia, Pennsylvania, United States, 19107 Upmc Hillman Cancer CenterPittsburgh, Pennsylvania, United States, 15213|Nashville, Tennessee, United States, 37203 Henry-Joyce Cancer CenterNashville, Tennessee, United States, 37232|Houston, Texas, United States, 77030|Salt Lake City, Utah, United States, 84112|Charlottesville, Virginia, United States, 22908|Seattle, Washington, United States, 98104","Alabama|Arizona|California|Florida|Illinois|Iowa|Kansas|Maryland|Massachusetts|Michigan|Minnesota|Missouri|New Jersey|New York|Ohio|Pennsylvania|Tennessee|Texas|Utah|Virginia|Washington","Australia|Austria|Belgium|Canada|France|Germany|Israel|Italy|Netherlands|Spain|Sweden|Switzerland|United Kingdom|United States","Victoria Peter Maccallum Cancer Center|Universitatsklinikum Graz, Division Of Hematology|Cliniques Universiaires Saint-Luc|British Columbia Vancouver General Hospital|Manitoba Cancercare Manitoba|Ontario Uninversity Health Network - Princess Margaret Cancer Center|Qeii Health Sciences Centre|Quebec Mcgill University Health Center|Chru De Lille - Hopital Claude Huriez|UniversitÃ¤ts-Klinikum Dresden|Tel Aviv Sourasky Medical Center|Instituto Di Ematologia \"L. E A. Seragnoli\" - Dipartimento Di Medicina Specialistica Diagnostica E Sperimentale|Academic Medical Center|Hospital Clinic De Barcelona|Skane University Hospital|Iosi, Ospedale Regionale Bellinzona E Valli|University Hospitals Birmingham Nhs Foundation Trust|University Of Alabama At Birmingham|Banner Md Anderson Cancer Center|Uc San Diego Moores Cancer Center|University Of Miami Hospital And Clinics/Sylvester Comprehensive Cancer Center|Northwestern University|University Of Iowa Hospitals And Clinincs|The University Of Kansas Cancer Center|University Of Maryland, Greenbaum Comprehensive Cancer Center|Dana-Farber Cancer Institute|Barbara Ann Karmanos Cancer Institute|Mayo Clinic, Patient Location|Washington University School Of Medicine|John Theurer Cancer Center At Hackensack University Medical Center|Memorial Sloan Kettering Cancer Center|Cleveland Clinic|Thomas Jefferson University|Sarah Cannon Research Institute|The University Of Texas, Md Anderson Cancer Center|University Of Utah, Huntsman Cancer Institute|University Of Virginia Health System|Swedish Cancer Institute",{"$nulls":3},"Kite Study Director","2020-04-06","2020-05-25T16:35:21.654","2020-05-26T17:10:42.972","NCT03391466"]
["5ecbf3c9feab101b155307e0","NCT03391765","2018-01-05","AbbVie","ABBV","Not yet recruiting","An Extension Study of ABBV-8E12 in Progressive Supranuclear Palsy (PSP)","Abbv-8e12",null,"Yes","['Abbv-8e12']","Unknown",null,"Phase 2",2,180,"Anticipated","2018-01-24","2024-09-12",{"$nulls":5},"The purpose of this study is to assess the long-term safety and efficacy of ABBV-8E12 in subjects with progressive supranuclear palsy (PSP).",null,"An Extension Study of ABBV-8E12 in Progressive Supranuclear Palsy (PSP)","M15-563","Progressive Supranuclear Palsy (PSP)","Supranuclear Palsy, Progressive","Central Nervous System Diseases","Central Nervous System","Experimental","Group 1|Group 2","Dose 1 ABBV-8E12|Dose 2 ABBV-8E12","Drug","ABBV-8E12","ABBV-8E12 (20 mg/mL) solution for IV infusion",null,"Group 1|Group 2","\n\n * Subject completed the 52-week treatment period in Study M15-562 (NCT02985879).\n * In the opinion of the investigator, the subject was compliant during participation in Study M15-562 (NCT02985879).\n * Subject has an identified, reliable, study partner (e.g., caregiver, family member, social worker, or friend).\n\n","\n\n * Subjects who weigh less than 44 kg (97 lbs) at the time of study entry.\n * Any contraindication or inability to tolerate brain magnetic resonance imaging (MRI).\n * Subject has any significant change in his/her medical condition that could interfere with the subject's participation in the study, could place the subject at increased risk, or could confound interpretation of study results.\n * More than 8 weeks have elapsed since the subject received his/her last dose of study drug in Study M15-562 (NCT02985879).\n * Subject is considered by the investigator, for any reason, to be an unsuitable candidate to receive ABBV-8E12 or the subject is considered by the investigator to be unable or unlikely to comply with the dosing schedule or study evaluations.",{"$nulls":4},"Actual","2018-01-05","Actual","Anticipated","2024-09-12","Anticipated","2018-01-01","2018-01-02","2018-01-02","2018-01-02","Yes","Steele-Richardson-Olszewski Syndrome\nPSP\ntauopathy","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","40 Years","99 Years","All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"2017-001590-16","EudraCT Number","Change in Progressive Supranuclear Palsy Rating Scale (PSPRS) Total Score from baseline up to 5 years","The PSPRS is a 28-item scale comprising 6 domains (daily activities, mentation, bulbar, ocular motor, limb motor, and gait/midline).","Up to approximately 5 years","Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living)|Change in Schwab and England Activities of Daily Living Scale (SEADL)|Change in Clinical Global Impression of Severity (CGI-S)|Clinical Global Impression of Change (CGI-C)|Change in Progressive Supranuclear Palsy Staging System (PSP-SS)|Patient Global Impression of Change (PGI-C)|Time to Loss of Ability To Walk Independently as Measured by PSPRS Item 26","The UPDRS is an investigator-used rating tool to follow the longitudinal course of Parkinson's disease.|The SEADL assesses the subject's ability to perform daily activities.|The CGI-S is a clinician's rating of disease severity.|The CGI-C is a clinician's rating of change in disease severity.|The PSP-SS is a composite of items from PSPRS.|The subject's evaluation of the change in their PSP-related symptoms.|The time to loss of ability to walk independently will be assessed using PSPRS Item 26 (Gait)","Up to approximately 5 years","abbvieclinicaltrials@abbvie.com","AbbVie_Call Center","847.283.8955",{"$nulls":7},"AbbVie Inc","2018-01-02","2020-05-25T16:35:21.405","2020-05-26T17:10:42.972","NCT03391765"]
["5ecbf3c9fe30261b1a0481b1","NCT03391765","2018-01-30","AbbVie","ABBV","Recruiting","An Extension Study of ABBV-8E12 in Progressive Supranuclear Palsy (PSP)","Abbv-8e12",null,"Yes","['Abbv-8e12']","Unknown",null,"Phase 2",2,340,"Anticipated","2018-01-24","2024-09-12",{"$nulls":5},"The purpose of this study is to assess the long-term safety and efficacy of ABBV-8E12 in subjects with progressive supranuclear palsy (PSP).",null,"An Extension Study of ABBV-8E12 in Progressive Supranuclear Palsy (PSP)","M15-563","Progressive Supranuclear Palsy (PSP)","Supranuclear Palsy, Progressive","Central Nervous System Diseases","Central Nervous System","Experimental","Group 2|Group 1","Dose 2 ABBV-8E12|Dose 1 ABBV-8E12","Drug","ABBV-8E12","ABBV-8E12 (20 mg/mL) solution for IV infusion",null,"Group 2|Group 1","\n\n * Subject completed the 52-week treatment period in Study M15-562 (NCT02985879).\n * In the opinion of the investigator, the subject was compliant during participation in Study M15-562 (NCT02985879).\n * Subject has an identified, reliable, study partner (e.g., caregiver, family member, social worker, or friend).\n\n","\n\n * Subjects who weigh less than 44 kg (97 lbs) at the time of study entry.\n * Any contraindication or inability to tolerate brain magnetic resonance imaging (MRI).\n * Subject has any significant change in his/her medical condition that could interfere with the subject's participation in the study, could place the subject at increased risk, or could confound interpretation of study results.\n * More than 8 weeks have elapsed since the subject received his/her last dose of study drug in Study M15-562 (NCT02985879).\n * Subject is considered by the investigator, for any reason, to be an unsuitable candidate to receive ABBV-8E12 or the subject is considered by the investigator to be unable or unlikely to comply with the dosing schedule or study evaluations.",{"$nulls":4},"Actual","2018-01-05","Actual","Anticipated","2024-09-12","Anticipated","2018-01-01","2018-01-02","2018-01-02","2018-01-26","Yes","tauopathy\nSteele-Richardson-Olszewski Syndrome\nPSP","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","40 Years","99 Years","All",null,"No","Undecided",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2017-001590-16","EudraCT Number","Change in Progressive Supranuclear Palsy Rating Scale (PSPRS) Total Score from baseline up to 5 years","The PSPRS is a 28-item scale comprising 6 domains (daily activities, mentation, bulbar, ocular motor, limb motor, and gait/midline).","Up to approximately 5 years","Time to Loss of Ability To Walk Independently as Measured by PSPRS Item 26|Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living)|Clinical Global Impression of Change (CGI-C)|Change in Clinical Global Impression of Severity (CGI-S)|Change in Schwab and England Activities of Daily Living Scale (SEADL)|Change in Progressive Supranuclear Palsy Staging System (PSP-SS)|Patient Global Impression of Change (PGI-C)","The time to loss of ability to walk independently will be assessed using PSPRS Item 26 (Gait)|The UPDRS is an investigator-used rating tool to follow the longitudinal course of Parkinson's disease.|The CGI-C is a clinician's rating of change in disease severity.|The CGI-S is a clinician's rating of disease severity.|The SEADL assesses the subject's ability to perform daily activities.|The PSP-SS is a composite of items from PSPRS.|The subject's evaluation of the change in their PSP-related symptoms.","Up to approximately 5 years","abbvieclinicaltrials@abbvie.com","ABBVIE CALL CENTER","847.283.8955","Augusta, Georgia, United States, 30912|Rozzano, Lombardia, Italy, 20089|Birmingham, Alabama, United States, 35294|Phoenix, Arizona, United States, 85054|Beverly Hills, California, United States, 90211 UscLos Angeles, California, United States, 90033 University Of California, Los AngelesLos Angeles, California, United States, 90095 University Of California, SanSan Diego, California, United States, 92037 Univ California, San FranciscoSan Francisco, California, United States, 94158|Englewood, Colorado, United States, 80113-2736|Gainesville, Florida, United States, 32607 Mayo ClinicJacksonville, Florida, United States, 32224 University Of South FloridaTampa, Florida, United States, 33612|Chicago, Illinois, United States, 60612 University Of Chicago MedicalChicago, Illinois, United States, 60637|Indianapolis, Indiana, United States, 46202|Lexington, Kentucky, United States, 40536|Rochester, Minnesota, United States, 55905-0001|Las Vegas, Nevada, United States, 89106|New Brunswick, New Jersey, United States, 08901|New York, New York, United States, 10032|Cleveland, Ohio, United States, 44195|Portland, Oregon, United States, 97239-3098|Nashville, Tennessee, United States, 37232-0011|Dallas, Texas, United States, 75218 Mcgovern Medical SchoolHouston, Texas, United States, 77054","Alabama|Arizona|California|Colorado|Florida|Illinois|Indiana|Kentucky|Minnesota|Nevada|New Jersey|New York|Ohio|Oregon|Tennessee|Texas","Georgia|Italy|United States","Regents University|Lombardia Istituto Clinico Humanitas|Univ Alabama-Birmingham|Mayo Clinic Arizona|Cedars-Sinai Medical Center|Rocky Mountain Movement Disorders Center|Uf Center For Movement Disorde|Rush Univ Med Ctr|Indiana University|Univ Kentucky Med Ctr|Mayo Clinic - Mayo Clinic -Methodist Campus -Pharmacy Research Support|Cleveland Clinic Lou Ruvo Cent|Rutgers Robert Wood Johnson|Weill Medical College Of Cornell University|Cleveland Clinic Foundation|Oregon Health And Science Univ|Vanderbilt University Medical Center|Texas Health Physicians Group",{"$nulls":3},"AbbVie Inc.","2018-01-26","2020-05-25T16:35:21.770","2020-05-26T17:10:42.972","NCT03391765"]
["5ecbf3c911702c1b1b9169c4","NCT03391765","2018-03-02","AbbVie","ABBV","Recruiting","An Extension Study of ABBV-8E12 in Progressive Supranuclear Palsy (PSP)","Abbv-8e12",null,"Yes","['Abbv-8e12']","Unknown",null,"Phase 2",2,340,"Anticipated","2018-01-24","2024-09-12",{"$nulls":5},"The purpose of this study is to assess the long-term safety and efficacy of ABBV-8E12 in subjects with progressive supranuclear palsy (PSP).",null,"An Extension Study of ABBV-8E12 in Progressive Supranuclear Palsy (PSP)","M15-563","Progressive Supranuclear Palsy (PSP)","Supranuclear Palsy, Progressive","Central Nervous System Diseases","Central Nervous System","Experimental","Group 2|Group 1","Dose 2 ABBV-8E12|Dose 1 ABBV-8E12","Drug","ABBV-8E12","ABBV-8E12 (20 mg/mL) solution for IV infusion",null,"Group 2|Group 1","\n\n * Subject completed the 52-week treatment period in Study M15-562 (NCT02985879).\n * In the opinion of the investigator, the subject was compliant during participation in Study M15-562 (NCT02985879).\n * Subject has an identified, reliable, study partner (e.g., caregiver, family member, social worker, or friend).\n\n","\n\n * Subjects who weigh less than 44 kg (97 lbs) at the time of study entry.\n * Any contraindication or inability to tolerate brain magnetic resonance imaging (MRI).\n * Subject has any significant change in his/her medical condition that could interfere with the subject's participation in the study, could place the subject at increased risk, or could confound interpretation of study results.\n * More than 8 weeks have elapsed since the subject received his/her last dose of study drug in Study M15-562 (NCT02985879).\n * Subject is considered by the investigator, for any reason, to be an unsuitable candidate to receive ABBV-8E12 or the subject is considered by the investigator to be unable or unlikely to comply with the dosing schedule or study evaluations.",{"$nulls":4},"Actual","2018-01-05","Actual","Anticipated","2024-09-12","Anticipated","2018-02-01","2018-01-02","2018-01-02","2018-02-28","Yes","tauopathy\nSteele-Richardson-Olszewski Syndrome\nPSP","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","40 Years",null,"All",null,"No","Undecided",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2017-001590-16","EudraCT Number","Change in Progressive Supranuclear Palsy Rating Scale (PSPRS) Total Score from baseline up to 5 years","The PSPRS is a 28-item scale comprising 6 domains (daily activities, mentation, bulbar, ocular motor, limb motor, and gait/midline).","Up to approximately 5 years","Time to Loss of Ability To Walk Independently as Measured by PSPRS Item 26|Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living)|Clinical Global Impression of Change (CGI-C)|Change in Clinical Global Impression of Severity (CGI-S)|Change in Schwab and England Activities of Daily Living Scale (SEADL)|Change in Progressive Supranuclear Palsy Staging System (PSP-SS)|Patient Global Impression of Change (PGI-C)","The time to loss of ability to walk independently will be assessed using PSPRS Item 26 (Gait)|The UPDRS is an investigator-used rating tool to follow the longitudinal course of Parkinson's disease.|The CGI-C is a clinician's rating of change in disease severity.|The CGI-S is a clinician's rating of disease severity.|The SEADL assesses the subject's ability to perform daily activities.|The PSP-SS is a composite of items from PSPRS.|The subject's evaluation of the change in their PSP-related symptoms.","Up to approximately 5 years","abbvieclinicaltrials@abbvie.com","ABBVIE CALL CENTER","847.283.8955","Augusta, Georgia, United States, 30912|Rozzano, Milano, Italy, 20089|Birmingham, Alabama, United States, 35294|Phoenix, Arizona, United States, 85054|Beverly Hills, California, United States, 90211 UscLos Angeles, California, United States, 90033 University Of California, Los AngelesLos Angeles, California, United States, 90095 University Of California, SanSan Diego, California, United States, 92037 Univ California, San FranciscoSan Francisco, California, United States, 94143-2204|Englewood, Colorado, United States, 80113-2736|Gainesville, Florida, United States, 32607 Mayo ClinicJacksonville, Florida, United States, 32224 University Of South FloridaTampa, Florida, United States, 33606-3603|Chicago, Illinois, United States, 60612 University Of Chicago MedicalChicago, Illinois, United States, 60637|Indianapolis, Indiana, United States, 46202|Lexington, Kentucky, United States, 40536|Rochester, Minnesota, United States, 55905-0001|Las Vegas, Nevada, United States, 89106|New Brunswick, New Jersey, United States, 08901|New York, New York, United States, 10032|Cleveland, Ohio, United States, 44195|Portland, Oregon, United States, 97239-3098|Nashville, Tennessee, United States, 37232-0011|Dallas, Texas, United States, 75218 Mcgovern Medical SchoolHouston, Texas, United States, 77054","Alabama|Arizona|California|Colorado|Florida|Illinois|Indiana|Kentucky|Minnesota|Nevada|New Jersey|New York|Ohio|Oregon|Tennessee|Texas","Georgia|Italy|United States","Regents University|Milano Istituto Clinico Humanitas|Univ Alabama-Birmingham|Mayo Clinic Arizona|Cedars-Sinai Medical Center|Rocky Mountain Movement Disorders Center|Uf Center For Movement Disorde|Rush University Medical Center|Indiana University|Univ Kentucky Med Ctr|Mayo Clinic|Cleveland Clinic Lou Ruvo Cent|Rutgers Robert Wood Johnson|Columbia University Medical Center-Ob/Gyn Department|Cleveland Clinic Foundation|Oregon Health And Science University|National Cancer Institute|Texas Health Physicians Group",{"$nulls":3},"AbbVie Inc.","2018-02-28","2020-05-25T16:35:21.696","2020-05-26T17:10:42.972","NCT03391765"]
["5ecbf3c911702c1b1b9169c5","NCT03391765","2018-04-02","AbbVie","ABBV","Recruiting","An Extension Study of ABBV-8E12 in Progressive Supranuclear Palsy (PSP)","Abbv-8e12",null,"Yes","['Abbv-8e12']","Unknown",null,"Phase 2",2,340,"Anticipated","2018-01-24","2022-09-22",{"$nulls":5},"The purpose of this study is to assess the long-term safety and efficacy of ABBV-8E12 in subjects with progressive supranuclear palsy (PSP).",null,"An Extension Study of ABBV-8E12 in Progressive Supranuclear Palsy (PSP)","M15-563","Progressive Supranuclear Palsy (PSP)","Supranuclear Palsy, Progressive","Central Nervous System Diseases","Central Nervous System","Experimental","Group 2|Group 1","Dose 2 ABBV-8E12|Dose 1 ABBV-8E12","Drug","ABBV-8E12","ABBV-8E12 (20 mg/mL) solution for IV infusion",null,"Group 2|Group 1","\n\n * Subject completed the 52-week treatment period in Study M15-562 (NCT02985879).\n * In the opinion of the investigator, the subject was compliant during participation in Study M15-562 (NCT02985879).\n * Subject has an identified, reliable, study partner (e.g., caregiver, family member, social worker, or friend).\n\n","\n\n * Subjects who weigh less than 44 kg (97 lbs) at the time of study entry.\n * Any contraindication or inability to tolerate brain magnetic resonance imaging (MRI).\n * Subject has any significant change in his/her medical condition that could interfere with the subject's participation in the study, could place the subject at increased risk, or could confound interpretation of study results.\n * More than 8 weeks have elapsed since the subject received his/her last dose of study drug in Study M15-562 (NCT02985879).\n * Subject is considered by the investigator, for any reason, to be an unsuitable candidate to receive ABBV-8E12 or the subject is considered by the investigator to be unable or unlikely to comply with the dosing schedule or study evaluations.",{"$nulls":4},"Actual","2018-01-05","Actual","Anticipated","2022-09-22","Anticipated","2018-03-01","2018-01-02","2018-01-02","2018-03-29","Yes","tauopathy\nSteele-Richardson-Olszewski Syndrome\nPSP","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","40 Years",null,"All",null,"No","Undecided",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2017-001590-16","EudraCT Number","Change in Progressive Supranuclear Palsy Rating Scale (PSPRS) Total Score from baseline up to 5 years","The PSPRS is a 28-item scale comprising 6 domains (daily activities, mentation, bulbar, ocular motor, limb motor, and gait/midline).","Up to approximately 5 years","Time to Loss of Ability To Walk Independently as Measured by PSPRS Item 26|Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living)|Clinical Global Impression of Change (CGI-C)|Change in Clinical Global Impression of Severity (CGI-S)|Change in Schwab and England Activities of Daily Living Scale (SEADL)|Change in Progressive Supranuclear Palsy Staging System (PSP-SS)|Patient Global Impression of Change (PGI-C)","The time to loss of ability to walk independently will be assessed using PSPRS Item 26 (Gait)|The UPDRS is an investigator-used rating tool to follow the longitudinal course of Parkinson's disease.|The CGI-C is a clinician's rating of change in disease severity.|The CGI-S is a clinician's rating of disease severity.|The SEADL assesses the subject's ability to perform daily activities.|The PSP-SS is a composite of items from PSPRS.|The subject's evaluation of the change in their PSP-related symptoms.","Up to approximately 5 years","abbvieclinicaltrials@abbvie.com","ABBVIE CALL CENTER","847.283.8955","Augusta, Georgia, United States, 30912|Rozzano, Milano, Italy, 20089|Birmingham, Alabama, United States, 35294|Phoenix, Arizona, United States, 85054|Beverly Hills, California, United States, 90211 UscLos Angeles, California, United States, 90033 University Of California, Los AngelesLos Angeles, California, United States, 90095 University Of California, SanSan Diego, California, United States, 92037 Univ California, San FranciscoSan Francisco, California, United States, 94143-2204|Englewood, Colorado, United States, 80113-2736|Gainesville, Florida, United States, 32607 Mayo ClinicJacksonville, Florida, United States, 32224 University Of South FloridaTampa, Florida, United States, 33606-3603|Chicago, Illinois, United States, 60612 University Of Chicago MedicalChicago, Illinois, United States, 60637|Indianapolis, Indiana, United States, 46202|Lexington, Kentucky, United States, 40536|Rochester, Minnesota, United States, 55905-0001|Las Vegas, Nevada, United States, 89106|New Brunswick, New Jersey, United States, 08901|New York, New York, United States, 10032-3725|Cleveland, Ohio, United States, 44195|Portland, Oregon, United States, 97239-3098|Nashville, Tennessee, United States, 37232-0011|Dallas, Texas, United States, 75218 Mcgovern Medical SchoolHouston, Texas, United States, 77054","Alabama|Arizona|California|Colorado|Florida|Illinois|Indiana|Kentucky|Minnesota|Nevada|New Jersey|New York|Ohio|Oregon|Tennessee|Texas","Georgia|Italy|United States","Regents University|Milano Istituto Clinico Humanitas|Univ Alabama-Birmingham|Mayo Clinic Arizona|Cedars-Sinai Medical Center|Rocky Mountain Movement Disorders Center|Uf Center For Movement Disorde|Rush University Medical Center|Indiana University|Univ Kentucky Med Ctr|Mayo Clinic|Cleveland Clinic Lou Ruvo Cent|Rutgers Robert Wood Johnson|Columbia Univ Medical Center|Cleveland Clinic Foundation|Oregon Health And Science University|Vanderbilt Univ Med Ctr|Texas Health Physicians Group",{"$nulls":3},"AbbVie Inc.","2018-03-29","2020-05-25T16:35:21.922","2020-05-26T17:10:42.972","NCT03391765"]
["5ecbf3c9feab101b155307e1","NCT03391765","2018-04-30","AbbVie","ABBV","Recruiting","An Extension Study of ABBV-8E12 in Progressive Supranuclear Palsy (PSP)","Abbv-8e12",null,"Yes","['Abbv-8e12']","Unknown",null,"Phase 2",2,330,"Anticipated","2018-01-24","2022-09-22",{"$nulls":5},"The purpose of this study is to assess the long-term safety and efficacy of ABBV-8E12 in subjects with progressive supranuclear palsy (PSP).",null,"An Extension Study of ABBV-8E12 in Progressive Supranuclear Palsy (PSP)","M15-563","Progressive Supranuclear Palsy (PSP)","Supranuclear Palsy, Progressive","Central Nervous System Diseases","Central Nervous System","Experimental","Group 2|Group 1","Dose 2 ABBV-8E12|Dose 1 ABBV-8E12","Drug","ABBV-8E12","ABBV-8E12 solution for IV infusion",null,"Group 2|Group 1","\n\n * Subject completed the 52-week treatment period in Study M15-562 (NCT02985879).\n * In the opinion of the investigator, the subject was compliant during participation in Study M15-562 (NCT02985879).\n * Subject has an identified, reliable, study partner (e.g., caregiver, family member, social worker, or friend).\n\n","\n\n * Subjects who weigh less than 44 kg (97 lbs) at the time of study entry.\n * Any contraindication or inability to tolerate brain magnetic resonance imaging (MRI).\n * Subject has any significant change in his/her medical condition that could interfere with the subject's participation in the study, could place the subject at increased risk, or could confound interpretation of study results.\n * More than 8 weeks have elapsed since the subject received his/her last dose of study drug in Study M15-562 (NCT02985879).\n * Subject is considered by the investigator, for any reason, to be an unsuitable candidate to receive ABBV-8E12 or the subject is considered by the investigator to be unable or unlikely to comply with the dosing schedule or study evaluations.",{"$nulls":4},"Actual","2018-01-05","Actual","Anticipated","2022-09-22","Anticipated","2018-04-01","2018-01-02","2018-01-02","2018-04-27","Yes","tauopathy\nSteele-Richardson-Olszewski Syndrome\nPSP","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","40 Years",null,"All",null,"No","Undecided",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2017-001590-16","EudraCT Number","Change in Progressive Supranuclear Palsy Rating Scale (PSPRS) Total Score from baseline up to 5 years","The PSPRS is a 28-item scale comprising 6 domains (daily activities, mentation, bulbar, ocular motor, limb motor, and gait/midline).","Up to approximately 5 years","Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living)|Change in Clinical Global Impression of Change (CGI-C)|Change in Schwab and England Activities of Daily Living Scale (SEADL)","The UPDRS is an investigator-used rating tool to follow the longitudinal course of Parkinson's disease.|The CGI-C is a clinician's rating of change in disease severity.|The SEADL assesses the subject's ability to perform daily activities.","Up to approximately 5 years","abbvieclinicaltrials@abbvie.com","ABBVIE CALL CENTER","847.283.8955","Augusta, Georgia, United States, 30912|Rozzano, Milano, Italy, 20089|Birmingham, Alabama, United States, 35294|Phoenix, Arizona, United States, 85054|Beverly Hills, California, United States, 90211 UscLos Angeles, California, United States, 90033 University Of California, Los AngelesLos Angeles, California, United States, 90095 University Of California, SanSan Diego, California, United States, 92037 Univ California, San FranciscoSan Francisco, California, United States, 94143-2204|Englewood, Colorado, United States, 80113-2736|Gainesville, Florida, United States, 32607 Mayo ClinicJacksonville, Florida, United States, 32224 University Of South FloridaTampa, Florida, United States, 33606-3603|Chicago, Illinois, United States, 60612 University Of Chicago MedicalChicago, Illinois, United States, 60637|Indianapolis, Indiana, United States, 46202|Lexington, Kentucky, United States, 40536|Rochester, Minnesota, United States, 55905-0001|Las Vegas, Nevada, United States, 89106|New Brunswick, New Jersey, United States, 08901|New York, New York, United States, 10032-3725|Cleveland, Ohio, United States, 44195|Portland, Oregon, United States, 97239-3098|Nashville, Tennessee, United States, 37232-0011|Dallas, Texas, United States, 75218 Mcgovern Medical SchoolHouston, Texas, United States, 77054","Alabama|Arizona|California|Colorado|Florida|Illinois|Indiana|Kentucky|Minnesota|Nevada|New Jersey|New York|Ohio|Oregon|Tennessee|Texas","Georgia|Italy|United States","Regents University|Milano Istituto Clinico Humanitas|Univ Alabama-Birmingham|Mayo Clinic Arizona|Cedars-Sinai Medical Center|Rocky Mountain Movement Disorders Center|Uf Center For Movement Disorde|Rush University Medical Center|Indiana University|Univ Kentucky Med Ctr|Mayo Clinic|Cleveland Clinic Lou Ruvo Cent|Rutgers Robert Wood Johnson|Columbia Univ Medical Center|Cleveland Clinic Foundation|Oregon Health And Science University|Vanderbilt Univ Med Ctr|Texas Health Physicians Group",{"$nulls":3},"AbbVie Inc.","2018-04-27","2020-05-25T16:35:21.908","2020-05-26T17:10:42.972","NCT03391765"]
["5ecbf3cafe30261b1a0481b2","NCT03391765","2018-05-31","AbbVie","ABBV","Recruiting","An Extension Study of ABBV-8E12 in Progressive Supranuclear Palsy (PSP)","Abbv-8e12",null,"Yes","['Abbv-8e12']","Unknown",null,"Phase 2",2,330,"Anticipated","2018-01-24","2022-09-22",{"$nulls":5},"The purpose of this study is to assess the long-term safety and efficacy of ABBV-8E12 in subjects with progressive supranuclear palsy (PSP).",null,"An Extension Study of ABBV-8E12 in Progressive Supranuclear Palsy (PSP)","M15-563","Progressive Supranuclear Palsy (PSP)","Supranuclear Palsy, Progressive","Central Nervous System Diseases","Central Nervous System","Experimental","Group 2|Group 1","Dose 2 ABBV-8E12|Dose 1 ABBV-8E12","Drug","ABBV-8E12","ABBV-8E12 solution for IV infusion",null,"Group 2|Group 1","\n\n * Subject completed the 52-week treatment period in Study M15-562 (NCT02985879).\n * In the opinion of the investigator, the subject was compliant during participation in Study M15-562 (NCT02985879).\n * Subject has an identified, reliable, study partner (e.g., caregiver, family member, social worker, or friend).\n\n","\n\n * Subjects who weigh less than 44 kg (97 lbs) at the time of study entry.\n * Any contraindication or inability to tolerate brain magnetic resonance imaging (MRI).\n * Subject has any significant change in his/her medical condition that could interfere with the subject's participation in the study, could place the subject at increased risk, or could confound interpretation of study results.\n * More than 8 weeks have elapsed since the subject received his/her last dose of study drug in Study M15-562 (NCT02985879).\n * Subject is considered by the investigator, for any reason, to be an unsuitable candidate to receive ABBV-8E12 or the subject is considered by the investigator to be unable or unlikely to comply with the dosing schedule or study evaluations.",{"$nulls":4},"Actual","2018-01-05","Actual","Anticipated","2022-09-22","Anticipated","2018-05-01","2018-01-02","2018-01-02","2018-05-29","Yes","tauopathy\nSteele-Richardson-Olszewski Syndrome\nPSP","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","40 Years",null,"All",null,"No","Undecided",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2017-001590-16","EudraCT Number","Change in Progressive Supranuclear Palsy Rating Scale (PSPRS) Total Score from baseline up to 5 years","The PSPRS is a 28-item scale comprising 6 domains (daily activities, mentation, bulbar, ocular motor, limb motor, and gait/midline).","Up to approximately 5 years","Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living)|Change in Clinical Global Impression of Change (CGI-C)|Change in Schwab and England Activities of Daily Living Scale (SEADL)","The UPDRS is an investigator-used rating tool to follow the longitudinal course of Parkinson's disease.|The CGI-C is a clinician's rating of change in disease severity.|The SEADL assesses the subject's ability to perform daily activities.","Up to approximately 5 years","abbvieclinicaltrials@abbvie.com","ABBVIE CALL CENTER","847.283.8955","Augusta, Georgia, United States, 30912|Rome, Lazio, Italy, 00168|Rozzano, Milano, Italy, 20089|Catanzaro, Italy, 88100 Istituto Neuro Mediterraneo IrPozzilli, Italy, 86077 A.O. Santa MariaTerni, Italy, 05100 Irccs San CamilloVenice, Italy, 30126|Birmingham, Alabama, United States, 35294|Phoenix, Arizona, United States, 85054|Beverly Hills, California, United States, 90211 UscLos Angeles, California, United States, 90033 University Of California, Los AngelesLos Angeles, California, United States, 90095 University Of California, SanSan Diego, California, United States, 92037 Univ California, San FranciscoSan Francisco, California, United States, 94143-2204|Englewood, Colorado, United States, 80113-2736|Gainesville, Florida, United States, 32607 Mayo ClinicJacksonville, Florida, United States, 32224 University Of South FloridaTampa, Florida, United States, 33606-3603|Chicago, Illinois, United States, 60612 University Of Chicago MedicalChicago, Illinois, United States, 60637|Indianapolis, Indiana, United States, 46202|Lexington, Kentucky, United States, 40536|Rochester, Minnesota, United States, 55905-0001|Las Vegas, Nevada, United States, 89106|New Brunswick, New Jersey, United States, 08901|New York, New York, United States, 10032-3725|Cleveland, Ohio, United States, 44195|Portland, Oregon, United States, 97239-3098|Nashville, Tennessee, United States, 37232-0011|Dallas, Texas, United States, 75218 Mcgovern Medical SchoolHouston, Texas, United States, 77054","Alabama|Arizona|California|Colorado|Florida|Illinois|Indiana|Kentucky|Minnesota|Nevada|New Jersey|New York|Ohio|Oregon|Tennessee|Texas","Georgia|Italy|United States","Regents University|Lazio Ao Univ Policlinico Agostino G|Milano Istituto Clinico Humanitas|University Of Catanzaro|Univ Alabama-Birmingham|Mayo Clinic Arizona|Cedars-Sinai Medical Center|Rocky Mountain Movement Disorders Center|Uf Center For Movement Disorde|Rush University Medical Center|Indiana University|Univ Kentucky Med Ctr|Mayo Clinic|Cleveland Clinic Lou Ruvo Cent|Rutgers Robert Wood Johnson|Columbia Univ Medical Center|Cleveland Clinic Foundation|Oregon Health And Science University|Vanderbilt Univ Med Ctr|Texas Health Physicians Group",{"$nulls":3},"AbbVie Inc.","2018-05-29","2020-05-25T16:35:22.096","2020-05-26T17:10:42.972","NCT03391765"]
["5ecbf3cae2561b1b11905cae","NCT03391765","2018-06-14","AbbVie","ABBV","Recruiting","An Extension Study of ABBV-8E12 in Progressive Supranuclear Palsy (PSP)","Abbv-8e12",null,"Yes","['Abbv-8e12']","Unknown",null,"Phase 2",2,330,"Anticipated","2018-01-24","2022-09-22",{"$nulls":5},"The purpose of this study is to assess the long-term safety and efficacy of ABBV-8E12 in subjects with progressive supranuclear palsy (PSP).",null,"An Extension Study of ABBV-8E12 in Progressive Supranuclear Palsy (PSP)","M15-563","Progressive Supranuclear Palsy (PSP)","Supranuclear Palsy, Progressive","Central Nervous System Diseases","Central Nervous System","Experimental","Group 2|Group 1","Dose 2 ABBV-8E12|Dose 1 ABBV-8E12","Drug","ABBV-8E12","ABBV-8E12 solution for IV infusion",null,"Group 2|Group 1","\n\n * Subject completed the 52-week treatment period in Study M15-562 (NCT02985879).\n * In the opinion of the investigator, the subject was compliant during participation in Study M15-562 (NCT02985879).\n * Subject has an identified, reliable, study partner (e.g., caregiver, family member, social worker, or friend).\n\n","\n\n * Subjects who weigh less than 44 kg (97 lbs) at the time of study entry.\n * Any contraindication or inability to tolerate brain magnetic resonance imaging (MRI).\n * Subject has any significant change in his/her medical condition that could interfere with the subject's participation in the study, could place the subject at increased risk, or could confound interpretation of study results.\n * More than 8 weeks have elapsed since the subject received his/her last dose of study drug in Study M15-562 (NCT02985879).\n * Subject is considered by the investigator, for any reason, to be an unsuitable candidate to receive ABBV-8E12 or the subject is considered by the investigator to be unable or unlikely to comply with the dosing schedule or study evaluations.",{"$nulls":4},"Actual","2018-01-05","Actual","Anticipated","2022-09-22","Anticipated","2018-06-01","2018-01-02","2018-01-02","2018-06-13","Yes","tauopathy\nSteele-Richardson-Olszewski Syndrome\nPSP","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","40 Years",null,"All",null,"No","Undecided",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2017-001590-16","EudraCT Number","Change in Progressive Supranuclear Palsy Rating Scale (PSPRS) Total Score from baseline up to 5 years","The PSPRS is a 28-item scale comprising 6 domains (daily activities, mentation, bulbar, ocular motor, limb motor, and gait/midline).","Up to approximately 5 years","Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living)|Change in Clinical Global Impression of Change (CGI-C)|Change in Schwab and England Activities of Daily Living Scale (SEADL)","The UPDRS is an investigator-used rating tool to follow the longitudinal course of Parkinson's disease.|The CGI-C is a clinician's rating of change in disease severity.|The SEADL assesses the subject's ability to perform daily activities.","Up to approximately 5 years","abbvieclinicaltrials@abbvie.com","ABBVIE CALL CENTER","847.283.8955","Augusta, Georgia, United States, 30912|Rome, Lazio, Italy, 00168|Rozzano, Milano, Italy, 20089|Catanzaro, Italy, 88100 Istituto Neuro Mediterraneo IrPozzilli, Italy, 86077 A.O. Santa MariaTerni, Italy, 05100 Irccs San CamilloVenice, Italy, 30126|Birmingham, Alabama, United States, 35294|Phoenix, Arizona, United States, 85054|Beverly Hills, California, United States, 90211 UscLos Angeles, California, United States, 90033 University Of California, Los AngelesLos Angeles, California, United States, 90095 University Of California, SanSan Diego, California, United States, 92037 Univ California, San FranciscoSan Francisco, California, United States, 94143-2204|Englewood, Colorado, United States, 80113-2736|Gainesville, Florida, United States, 32607 Mayo ClinicJacksonville, Florida, United States, 32224 University Of South FloridaTampa, Florida, United States, 33606-3603|Chicago, Illinois, United States, 60612 University Of Chicago MedicalChicago, Illinois, United States, 60637|Indianapolis, Indiana, United States, 46202|Lexington, Kentucky, United States, 40536|Rochester, Minnesota, United States, 55905-0001|Las Vegas, Nevada, United States, 89106|New Brunswick, New Jersey, United States, 08901|New York, New York, United States, 10032-3725|Cleveland, Ohio, United States, 44195|Portland, Oregon, United States, 97239-3098|Nashville, Tennessee, United States, 37232-0011|Dallas, Texas, United States, 75218 Mcgovern Medical SchoolHouston, Texas, United States, 77054","Alabama|Arizona|California|Colorado|Florida|Illinois|Indiana|Kentucky|Minnesota|Nevada|New Jersey|New York|Ohio|Oregon|Tennessee|Texas","Georgia|Italy|United States","Regents University|Lazio Ao Univ Policlinico Agostino G|Milano Istituto Clinico Humanitas|University Of Catanzaro|Univ Alabama-Birmingham|Mayo Clinic Arizona|Cedars-Sinai Medical Center|Rocky Mountain Movement Disorders Center|Uf Center For Movement Disorde|Rush University Medical Center|Indiana University|Univ Kentucky Med Ctr|Mayo Clinic|Cleveland Clinic Lou Ruvo Cent|Rutgers Robert Wood Johnson|Columbia Univ Medical Center|Cleveland Clinic Foundation|Oregon Health And Science University|Vanderbilt Univ Med Ctr|Texas Health Physicians Group",{"$nulls":3},"AbbVie Inc.","2018-06-13","2020-05-25T16:35:22.228","2020-05-26T17:10:42.972","NCT03391765"]
["5ecbf3c9e2561b1b11905cad","NCT03391765","2018-08-01","AbbVie","ABBV","Recruiting","An Extension Study of ABBV-8E12 in Progressive Supranuclear Palsy (PSP)","Abbv-8e12",null,"Yes","['Abbv-8e12']","Unknown",null,"Phase 2",2,330,"Anticipated","2018-01-24","2022-09-22",{"$nulls":5},"The purpose of this study is to assess the long-term safety and efficacy of ABBV-8E12 in subjects with progressive supranuclear palsy (PSP).",null,"An Extension Study of ABBV-8E12 in Progressive Supranuclear Palsy (PSP)","M15-563","Progressive Supranuclear Palsy (PSP)","Supranuclear Palsy, Progressive","Central Nervous System Diseases","Central Nervous System","Experimental","Group 2|Group 1","Dose 2 ABBV-8E12|Dose 1 ABBV-8E12","Drug","ABBV-8E12","ABBV-8E12 solution for IV infusion",null,"Group 2|Group 1","\n\n * Subject completed the 52-week treatment period in Study M15-562 (NCT02985879).\n * In the opinion of the investigator, the subject was compliant during participation in Study M15-562 (NCT02985879).\n * Subject has an identified, reliable, study partner (e.g., caregiver, family member, social worker, or friend).\n\n","\n\n * Subjects who weigh less than 44 kg (97 lbs) at the time of study entry.\n * Any contraindication or inability to tolerate brain magnetic resonance imaging (MRI).\n * Subject has any significant change in his/her medical condition that could interfere with the subject's participation in the study, could place the subject at increased risk, or could confound interpretation of study results.\n * More than 8 weeks have elapsed since the subject received his/her last dose of study drug in Study M15-562 (NCT02985879).\n * Subject is considered by the investigator, for any reason, to be an unsuitable candidate to receive ABBV-8E12 or the subject is considered by the investigator to be unable or unlikely to comply with the dosing schedule or study evaluations.",{"$nulls":4},"Actual","2018-01-05","Actual","Anticipated","2022-09-22","Anticipated","2018-07-01","2018-01-02","2018-01-02","2018-07-31","Yes","tauopathy\nSteele-Richardson-Olszewski Syndrome\nPSP","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","40 Years",null,"All",null,"No","Yes\nAbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2017-001590-16","EudraCT Number","Change in Progressive Supranuclear Palsy Rating Scale (PSPRS) Total Score from baseline up to 5 years","The PSPRS is a 28-item scale comprising 6 domains (daily activities, mentation, bulbar, ocular motor, limb motor, and gait/midline).","Up to approximately 5 years","Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living)|Change in Clinical Global Impression of Change (CGI-C)|Change in Schwab and England Activities of Daily Living Scale (SEADL)","The UPDRS is an investigator-used rating tool to follow the longitudinal course of Parkinson's disease.|The CGI-C is a clinician's rating of change in disease severity.|The SEADL assesses the subject's ability to perform daily activities.","Up to approximately 5 years","abbvieclinicaltrials@abbvie.com","ABBVIE CALL CENTER","847.283.8955","Augusta, Georgia, United States, 30912|Rome, Lazio, Italy, 00168|Rozzano, Milano, Italy, 20089|Catanzaro, Italy, 88100 Istituto Neuro Mediterraneo Ir /Id# 165533Pozzilli, Italy, 86077 A.O. Santa Maria /Id# 165535Terni, Italy, 05100 Irccs San Camillo /Id# 201229Venice, Italy, 30126|Birmingham, Alabama, United States, 35294|Phoenix, Arizona, United States, 85054|Beverly Hills, California, United States, 90211 Usc /Id# 165529Los Angeles, California, United States, 90033 University Of California, San /Id# 165560San Diego, California, United States, 92037 Univ California, San Francisco /Id# 165553San Francisco, California, United States, 94143-2204 University Of California, Los Angeles /Id# 165669Santa Monica, California, United States, 90404|Englewood, Colorado, United States, 80113-2736|Gainesville, Florida, United States, 32607 Mayo Clinic /Id# 165554Jacksonville, Florida, United States, 32224 University Of South Florida /Id# 165556Tampa, Florida, United States, 33606-3603|Chicago, Illinois, United States, 60612 University Of Chicago Medical /Id# 165555Chicago, Illinois, United States, 60637|Indianapolis, Indiana, United States, 46202|Lexington, Kentucky, United States, 40536|Rochester, Minnesota, United States, 55905-0001|Las Vegas, Nevada, United States, 89106|New Brunswick, New Jersey, United States, 08901|New York, New York, United States, 10032-3725|Cleveland, Ohio, United States, 44195|Portland, Oregon, United States, 97239-3098|Nashville, Tennessee, United States, 37232-0011|Dallas, Texas, United States, 75218 Mcgovern Medical School /Id# 165565Houston, Texas, United States, 77054","Alabama|Arizona|California|Colorado|Florida|Illinois|Indiana|Kentucky|Minnesota|Nevada|New Jersey|New York|Ohio|Oregon|Tennessee|Texas","Georgia|Italy|United States","Regents University /Id# 165562|Lazio Ao Univ Policlinico Agostino G /Id# 165536|Milano Istituto Clinico Humanitas /Id# 165531|University Of Catanzaro /Id# 170214|Univ Alabama-Birmingham /Id# 165522|Mayo Clinic Arizona /Id# 165521|Cedars-Sinai Medical Center /Id# 165567|Rocky Mountain Movement Disorders Center /Id# 165559|Uf Center For Movement Disorde /Id# 165561|Rush University Medical Center /Id# 165527|Indiana University /Id# 165519|University Of Kentucky Chandler Medical Center /Id# 165566|Mayo Clinic - Rochester /Id# 165518|Cleveland Clinic Lou Ruvo Cent /Id# 165538|Rutgers Robert Wood Johnson /Id# 165526|Columbia Univ Medical Center /Id# 165528|Cleveland Clinic Foundation /Id# 165537|Oregon Health And Science University /Id# 165564|Vanderbilt Univ Med Ctr /Id# 165520|Texas Health Physicians Group /Id# 165558",{"$nulls":3},"AbbVie Inc.","2018-07-31","2020-05-25T16:35:21.980","2020-05-26T17:10:42.972","NCT03391765"]
["5ecbf3ca307e3d1b1f8d9c42","NCT03391765","2018-08-31","AbbVie","ABBV","Recruiting","An Extension Study of ABBV-8E12 in Progressive Supranuclear Palsy (PSP)","Abbv-8e12",null,"Yes","['Abbv-8e12']","Unknown",null,"Phase 2",2,330,"Anticipated","2018-01-24","2022-09-22",{"$nulls":5},"The purpose of this study is to assess the long-term safety and efficacy of ABBV-8E12 in subjects with progressive supranuclear palsy (PSP).",null,"An Extension Study of ABBV-8E12 in Progressive Supranuclear Palsy (PSP)","M15-563","Progressive Supranuclear Palsy (PSP)","Supranuclear Palsy, Progressive","Central Nervous System Diseases","Central Nervous System","Experimental","Group 2|Group 1","Dose 2 ABBV-8E12|Dose 1 ABBV-8E12","Drug","ABBV-8E12","ABBV-8E12 solution for IV infusion",null,"Group 2|Group 1","\n\n * Subject completed the 52-week treatment period in Study M15-562 (NCT02985879).\n * In the opinion of the investigator, the subject was compliant during participation in Study M15-562 (NCT02985879).\n * Subject has an identified, reliable, study partner (e.g., caregiver, family member, social worker, or friend).\n\n","\n\n * Subjects who weigh less than 44 kg (97 lbs) at the time of study entry.\n * Any contraindication or inability to tolerate brain magnetic resonance imaging (MRI).\n * Subject has any significant change in his/her medical condition that could interfere with the subject's participation in the study, could place the subject at increased risk, or could confound interpretation of study results.\n * More than 8 weeks have elapsed since the subject received his/her last dose of study drug in Study M15-562 (NCT02985879).\n * Subject is considered by the investigator, for any reason, to be an unsuitable candidate to receive ABBV-8E12 or the subject is considered by the investigator to be unable or unlikely to comply with the dosing schedule or study evaluations.",{"$nulls":4},"Actual","2018-01-05","Actual","Anticipated","2022-09-22","Anticipated","2018-08-01","2018-01-02","2018-01-02","2018-08-28","Yes","tauopathy\nSteele-Richardson-Olszewski Syndrome\nPSP","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","40 Years",null,"All",null,"No","Yes\nAbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2017-001590-16","EudraCT Number","Change in Progressive Supranuclear Palsy Rating Scale (PSPRS) Total Score from baseline up to 5 years","The PSPRS is a 28-item scale comprising 6 domains (daily activities, mentation, bulbar, ocular motor, limb motor, and gait/midline).","Up to approximately 5 years","Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living)|Change in Clinical Global Impression of Change (CGI-C)|Change in Schwab and England Activities of Daily Living Scale (SEADL)","The UPDRS is an investigator-used rating tool to follow the longitudinal course of Parkinson's disease.|The CGI-C is a clinician's rating of change in disease severity.|The SEADL assesses the subject's ability to perform daily activities.","Up to approximately 5 years","abbvieclinicaltrials@abbvie.com","ABBVIE CALL CENTER","847.283.8955","Toronto, Ontario, Canada, M5T 2S8|Montreal, Quebec, Canada, H3A 2B4 Chum - Notre-Dame Hospital /Id# 165461MontrÃ©al, Quebec, Canada, H2X 0A9|Augusta, Georgia, United States, 30912|Rome, Lazio, Italy, 00168|Rozzano, Milano, Italy, 20089|Catanzaro, Italy, 88100 Istituto Neuro Mediterraneo Ir /Id# 165533Pozzilli, Italy, 86077 A.O. Santa Maria /Id# 165535Terni, Italy, 05100 Irccs San Camillo /Id# 201229Venice, Italy, 30126|Birmingham, Alabama, United States, 35294|Phoenix, Arizona, United States, 85054|Beverly Hills, California, United States, 90211 Usc /Id# 165529Los Angeles, California, United States, 90033 University Of California, Los Angeles /Id# 165669Los Angeles, California, United States, 90095 University Of California, San /Id# 165560San Diego, California, United States, 92037 Univ California, San Francisco /Id# 165553San Francisco, California, United States, 94143-2204|Englewood, Colorado, United States, 80113-2736|Gainesville, Florida, United States, 32607 Mayo Clinic /Id# 165554Jacksonville, Florida, United States, 32224 University Of South Florida /Id# 165556Tampa, Florida, United States, 33606-3603|Chicago, Illinois, United States, 60612 University Of Chicago Medical /Id# 165555Chicago, Illinois, United States, 60637|Indianapolis, Indiana, United States, 46202|Lexington, Kentucky, United States, 40536|Rochester, Minnesota, United States, 55905-0001|Las Vegas, Nevada, United States, 89106|New Brunswick, New Jersey, United States, 08901|New York, New York, United States, 10032-3725|Cleveland, Ohio, United States, 44195|Portland, Oregon, United States, 97239-3098|Nashville, Tennessee, United States, 37232-0011|Dallas, Texas, United States, 75231-4316 Mcgovern Medical School /Id# 165565Houston, Texas, United States, 77054 Central Texas Neurology Consul /Id# 202223Round Rock, Texas, United States, 78681","Alabama|Arizona|California|Colorado|Florida|Illinois|Indiana|Kentucky|Minnesota|Nevada|New Jersey|New York|Ohio|Oregon|Tennessee|Texas","Canada|Georgia|Italy|United States","Ontario Toronto Western Hospital /Id# 165462|Quebec Montreal Neurological Institut /Id# 165546|Regents University /Id# 165562|Lazio Ao Univ Policlinico Agostino G /Id# 165536|Milano Istituto Clinico Humanitas /Id# 165531|University Of Catanzaro /Id# 170214|Univ Alabama-Birmingham /Id# 165522|Mayo Clinic Arizona /Id# 165521|Cedars-Sinai Medical Center /Id# 165567|Rocky Mountain Movement Disorders Center /Id# 165559|Uf Center For Movement Disorde /Id# 165561|Rush University Medical Center /Id# 165527|Indiana University /Id# 165519|University Of Kentucky Chandler Medical Center /Id# 165566|Mayo Clinic - Rochester /Id# 165518|Cleveland Clinic Lou Ruvo Cent /Id# 165538|Rutgers Robert Wood Johnson /Id# 165526|Columbia Univ Medical Center /Id# 165528|Cleveland Clinic Foundation /Id# 165537|Oregon Health And Science University /Id# 165564|Vanderbilt Univ Med Ctr /Id# 165520|Kerwin Research Center /Id# 206872",{"$nulls":3},"AbbVie Inc.","2018-08-28","2020-05-25T16:35:22.143","2020-05-26T17:10:42.972","NCT03391765"]
["5ecbf3cafeab101b155307e2","NCT03391765","2018-09-24","AbbVie","ABBV","Recruiting","An Extension Study of ABBV-8E12 in Progressive Supranuclear Palsy (PSP)","Abbv-8e12",null,"Yes","['Abbv-8e12']","Unknown",null,"Phase 2",2,330,"Anticipated","2018-01-24","2022-09-22",{"$nulls":5},"The purpose of this study is to assess the long-term safety and efficacy of ABBV-8E12 in subjects with progressive supranuclear palsy (PSP).",null,"An Extension Study of ABBV-8E12 in Progressive Supranuclear Palsy (PSP)","M15-563","Progressive Supranuclear Palsy (PSP)","Supranuclear Palsy, Progressive","Central Nervous System Diseases","Central Nervous System","Experimental","Group 2|Group 1","Dose 2 ABBV-8E12|Dose 1 ABBV-8E12","Drug","ABBV-8E12","ABBV-8E12 solution for IV infusion",null,"Group 2|Group 1","\n\n * Subject completed the 52-week treatment period in Study M15-562 (NCT02985879).\n * In the opinion of the investigator, the subject was compliant during participation in Study M15-562 (NCT02985879).\n * Subject has an identified, reliable, study partner (e.g., caregiver, family member, social worker, or friend).\n\n","\n\n * Subjects who weigh less than 44 kg (97 lbs) at the time of study entry.\n * Any contraindication or inability to tolerate brain magnetic resonance imaging (MRI).\n * Subject has any significant change in his/her medical condition that could interfere with the subject's participation in the study, could place the subject at increased risk, or could confound interpretation of study results.\n * More than 8 weeks have elapsed since the subject received his/her last dose of study drug in Study M15-562 (NCT02985879).\n * Subject is considered by the investigator, for any reason, to be an unsuitable candidate to receive ABBV-8E12 or the subject is considered by the investigator to be unable or unlikely to comply with the dosing schedule or study evaluations.",{"$nulls":4},"Actual","2018-01-05","Actual","Anticipated","2022-09-22","Anticipated","2018-09-01","2018-01-02","2018-01-02","2018-09-21","Yes","tauopathy\nSteele-Richardson-Olszewski Syndrome\nPSP","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","40 Years",null,"All",null,"No","Yes\nAbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2017-001590-16","EudraCT Number","Change in Progressive Supranuclear Palsy Rating Scale (PSPRS) Total Score from baseline up to 5 years","The PSPRS is a 28-item scale comprising 6 domains (daily activities, mentation, bulbar, ocular motor, limb motor, and gait/midline).","Up to approximately 5 years","Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living)|Change in Clinical Global Impression of Change (CGI-C)|Change in Schwab and England Activities of Daily Living Scale (SEADL)","The UPDRS is an investigator-used rating tool to follow the longitudinal course of Parkinson's disease.|The CGI-C is a clinician's rating of change in disease severity.|The SEADL assesses the subject's ability to perform daily activities.","Up to approximately 5 years","abbvieclinicaltrials@abbvie.com","ABBVIE CALL CENTER","847.283.8955","Calgary, Alberta, Canada, T2N 4Z6|Toronto, Ontario, Canada, M5T 2S8|Montreal, Quebec, Canada, H3A 2B4 Chum - Notre-Dame Hospital /Id# 165461MontrÃ©al, Quebec, Canada, H2X 0A9|Augusta, Georgia, United States, 30912|Rome, Lazio, Italy, 00168|Rozzano, Milano, Italy, 20089|Catanzaro, Italy, 88100 Istituto Neuro Mediterraneo Ir /Id# 165533Pozzilli, Italy, 86077 A.O. Santa Maria /Id# 165535Terni, Italy, 05100 Irccs San Camillo /Id# 201229Venice, Italy, 30126|Birmingham, Alabama, United States, 35294|Phoenix, Arizona, United States, 85054|Beverly Hills, California, United States, 90211 Usc /Id# 165529Los Angeles, California, United States, 90033 University Of California, Los Angeles /Id# 165669Los Angeles, California, United States, 90095 University Of California, San /Id# 165560San Diego, California, United States, 92037 Univ California, San Francisco /Id# 165553San Francisco, California, United States, 94143-2204|Englewood, Colorado, United States, 80113-2736|Gainesville, Florida, United States, 32607 Mayo Clinic /Id# 165554Jacksonville, Florida, United States, 32224 University Of South Florida /Id# 165556Tampa, Florida, United States, 33606-3603|Chicago, Illinois, United States, 60612 University Of Chicago Medical /Id# 165555Chicago, Illinois, United States, 60637|Indianapolis, Indiana, United States, 46202|Lexington, Kentucky, United States, 40536|Rochester, Minnesota, United States, 55905-0001|Las Vegas, Nevada, United States, 89106|New Brunswick, New Jersey, United States, 08901|New York, New York, United States, 10032-3725|Cleveland, Ohio, United States, 44195|Portland, Oregon, United States, 97239-3098|Nashville, Tennessee, United States, 37232-0011|Dallas, Texas, United States, 75231-4316 Mcgovern Medical School /Id# 165565Houston, Texas, United States, 77054 Central Texas Neurology Consul /Id# 202223Round Rock, Texas, United States, 78681","Alabama|Arizona|California|Colorado|Florida|Illinois|Indiana|Kentucky|Minnesota|Nevada|New Jersey|New York|Ohio|Oregon|Tennessee|Texas","Canada|Georgia|Italy|United States","Alberta University Of Calgary /Id# 165667|Ontario Toronto Western Hospital /Id# 165462|Quebec Montreal Neurological Institut /Id# 165546|Regents University /Id# 165562|Lazio Ao Univ Policlinico Agostino G /Id# 165536|Milano Istituto Clinico Humanitas /Id# 165531|University Of Catanzaro /Id# 170214|Univ Alabama-Birmingham /Id# 165522|Mayo Clinic Arizona /Id# 165521|Cedars-Sinai Medical Center /Id# 165567|Rocky Mountain Movement Disorders Center /Id# 165559|Uf Center For Movement Disorde /Id# 165561|Rush University Medical Center /Id# 165527|Indiana University /Id# 165519|University Of Kentucky Chandler Medical Center /Id# 165566|Mayo Clinic - Rochester /Id# 165518|Cleveland Clinic Lou Ruvo Cent /Id# 165538|Rutgers Robert Wood Johnson /Id# 165526|Columbia Univ Medical Center /Id# 165528|Cleveland Clinic Foundation /Id# 165537|Oregon Health And Science University /Id# 165564|Vanderbilt Univ Med Ctr /Id# 165520|Kerwin Research Center /Id# 206872",{"$nulls":3},"AbbVie Inc.","2018-09-21","2020-05-25T16:35:22.216","2020-05-26T17:10:42.972","NCT03391765"]
["5ecbf3ca11702c1b1b9169c7","NCT03391765","2018-10-09","AbbVie","ABBV","Recruiting","An Extension Study of ABBV-8E12 in Progressive Supranuclear Palsy (PSP)","Abbv-8e12",null,"Yes","['Abbv-8e12']","Unknown",null,"Phase 2",2,330,"Anticipated","2018-01-24","2022-09-22",{"$nulls":5},"The purpose of this study is to assess the long-term safety and efficacy of ABBV-8E12 in subjects with progressive supranuclear palsy (PSP).",null,"An Extension Study of ABBV-8E12 in Progressive Supranuclear Palsy (PSP)","M15-563","Progressive Supranuclear Palsy (PSP)","Supranuclear Palsy, Progressive","Central Nervous System Diseases","Central Nervous System","Experimental","Group 2|Group 1","Dose 2 ABBV-8E12|Dose 1 ABBV-8E12","Drug","ABBV-8E12","ABBV-8E12 solution for IV infusion",null,"Group 2|Group 1","\n\n * Subject completed the 52-week treatment period in Study M15-562 (NCT02985879).\n * In the opinion of the investigator, the subject was compliant during participation in Study M15-562 (NCT02985879).\n * Subject has an identified, reliable, study partner (e.g., caregiver, family member, social worker, or friend).\n\n","\n\n * Subjects who weigh less than 44 kg (97 lbs) at the time of study entry.\n * Any contraindication or inability to tolerate brain magnetic resonance imaging (MRI).\n * Subject has any significant change in his/her medical condition that could interfere with the subject's participation in the study, could place the subject at increased risk, or could confound interpretation of study results.\n * More than 8 weeks have elapsed since the subject received his/her last dose of study drug in Study M15-562 (NCT02985879).\n * Subject is considered by the investigator, for any reason, to be an unsuitable candidate to receive ABBV-8E12 or the subject is considered by the investigator to be unable or unlikely to comply with the dosing schedule or study evaluations.",{"$nulls":4},"Actual","2018-01-05","Actual","Anticipated","2022-09-22","Anticipated","2018-10-01","2018-01-02","2018-01-02","2018-10-08","Yes","tauopathy\nSteele-Richardson-Olszewski Syndrome\nPSP","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","40 Years",null,"All",null,"No","Yes\nAbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2017-001590-16","EudraCT Number","Change in Progressive Supranuclear Palsy Rating Scale (PSPRS) Total Score from baseline up to 5 years","The PSPRS is a 28-item scale comprising 6 domains (daily activities, mentation, bulbar, ocular motor, limb motor, and gait/midline).","Up to approximately 5 years","Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living)|Change in Clinical Global Impression of Change (CGI-C)|Change in Schwab and England Activities of Daily Living Scale (SEADL)","The UPDRS is an investigator-used rating tool to follow the longitudinal course of Parkinson's disease.|The CGI-C is a clinician's rating of change in disease severity.|The SEADL assesses the subject's ability to perform daily activities.","Up to approximately 5 years","abbvieclinicaltrials@abbvie.com","ABBVIE CALL CENTER","847.283.8955","Calgary, Alberta, Canada, T2N 4Z6|Toronto, Ontario, Canada, M5T 2S8|Montreal, Quebec, Canada, H3A 2B4 Chum - Notre-Dame Hospital /Id# 165461MontrÃ©al, Quebec, Canada, H2X 0A9|Rome, Lazio, Italy, 00168|Rozzano, Milano, Italy, 20089|Turin, Piemonte, Italy, 10126|Catanzaro, Italy, 88100 Fondazione Irccs Istituto Neur /Id# 208737Milan, Italy, 20133 Istituto Neuro Mediterraneo Ir /Id# 165533Pozzilli, Italy, 86077 A.O. Santa Maria /Id# 165535Terni, Italy, 05100 Irccs San Camillo /Id# 201229Venice, Italy, 30126|Birmingham, Alabama, United States, 35294|Phoenix, Arizona, United States, 85054|Beverly Hills, California, United States, 90211 Usc /Id# 165529Los Angeles, California, United States, 90033 University Of California, Los Angeles /Id# 165669Los Angeles, California, United States, 90095 University Of California, San /Id# 165560San Diego, California, United States, 92037 Univ California, San Francisco /Id# 165553San Francisco, California, United States, 94143-2204|Englewood, Colorado, United States, 80113-2736|Gainesville, Florida, United States, 32607 Mayo Clinic /Id# 165554Jacksonville, Florida, United States, 32224 University Of South Florida /Id# 165556Tampa, Florida, United States, 33606-3603|Augusta, Georgia, United States, 30912-0004|Chicago, Illinois, United States, 60612 University Of Chicago Medical /Id# 165555Chicago, Illinois, United States, 60637|Indianapolis, Indiana, United States, 46202|Lexington, Kentucky, United States, 40536|Rochester, Minnesota, United States, 55905-0001|Las Vegas, Nevada, United States, 89106|New Brunswick, New Jersey, United States, 08901|New York, New York, United States, 10032-3725|Cleveland, Ohio, United States, 44195|Portland, Oregon, United States, 97239-3098|Nashville, Tennessee, United States, 37232-0011|Dallas, Texas, United States, 75231-4316 Mcgovern Medical School /Id# 165565Houston, Texas, United States, 77054 Central Texas Neurology Consul /Id# 202223Round Rock, Texas, United States, 78681","Alabama|Arizona|California|Colorado|Florida|Georgia|Illinois|Indiana|Kentucky|Minnesota|Nevada|New Jersey|New York|Ohio|Oregon|Tennessee|Texas","Canada|Italy|United States","Alberta University Of Calgary /Id# 165667|Ontario Toronto Western Hospital /Id# 165462|Quebec Montreal Neurological Institut /Id# 165546|Lazio Ao Univ Policlinico Agostino G /Id# 165536|Milano Istituto Clinico Humanitas /Id# 165531|Piemonte Aou Citta Della Salute Scienza /Id# 208736|University Of Catanzaro /Id# 170214|Univ Alabama-Birmingham /Id# 165522|Mayo Clinic Arizona /Id# 165521|Cedars-Sinai Medical Center /Id# 165567|Rocky Mountain Movement Disorders Center /Id# 165559|Uf Center For Movement Disorde /Id# 165561|Augusta University Medical Center /Id# 165562|Rush University Medical Center /Id# 165527|Indiana University /Id# 165519|University Of Kentucky Chandler Medical Center /Id# 165566|Mayo Clinic - Rochester /Id# 165518|Cleveland Clinic Lou Ruvo Cent /Id# 165538|Rutgers Robert Wood Johnson /Id# 165526|Columbia Univ Medical Center /Id# 165528|Cleveland Clinic Foundation /Id# 165537|Oregon Health And Science University /Id# 165564|Vanderbilt Univ Med Ctr /Id# 165520|Kerwin Research Center /Id# 206872",{"$nulls":3},"AbbVie Inc.","2018-10-08","2020-05-25T16:35:22.854","2020-05-26T17:10:42.972","NCT03391765"]
["5ecbf3cafeab101b155307e3","NCT03391765","2018-10-11","AbbVie","ABBV","Recruiting","An Extension Study of ABBV-8E12 in Progressive Supranuclear Palsy (PSP)","Abbv-8e12",null,"Yes","['Abbv-8e12']","Unknown",null,"Phase 2",2,330,"Anticipated","2018-01-24","2022-09-22",{"$nulls":5},"The purpose of this study is to assess the long-term safety and efficacy of ABBV-8E12 in subjects with progressive supranuclear palsy (PSP).",null,"An Extension Study of ABBV-8E12 in Progressive Supranuclear Palsy (PSP)","M15-563","Progressive Supranuclear Palsy (PSP)","Supranuclear Palsy, Progressive","Central Nervous System Diseases","Central Nervous System","Experimental","Group 2|Group 1","Dose 2 ABBV-8E12|Dose 1 ABBV-8E12","Drug","ABBV-8E12","ABBV-8E12 solution for IV infusion",null,"Group 2|Group 1","\n\n * Subject completed the 52-week treatment period in Study M15-562 (NCT02985879).\n * In the opinion of the investigator, the subject was compliant during participation in Study M15-562 (NCT02985879).\n * Subject has an identified, reliable, study partner (e.g., caregiver, family member, social worker, or friend).\n\n","\n\n * Subjects who weigh less than 44 kg (97 lbs) at the time of study entry.\n * Any contraindication or inability to tolerate brain magnetic resonance imaging (MRI).\n * Subject has any significant change in his/her medical condition that could interfere with the subject's participation in the study, could place the subject at increased risk, or could confound interpretation of study results.\n * More than 8 weeks have elapsed since the subject received his/her last dose of study drug in Study M15-562 (NCT02985879).\n * Subject is considered by the investigator, for any reason, to be an unsuitable candidate to receive ABBV-8E12 or the subject is considered by the investigator to be unable or unlikely to comply with the dosing schedule or study evaluations.",{"$nulls":4},"Actual","2018-01-05","Actual","Anticipated","2022-09-22","Anticipated","2018-10-01","2018-01-02","2018-01-02","2018-10-09","Yes","tauopathy\nSteele-Richardson-Olszewski Syndrome\nPSP","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","40 Years",null,"All",null,"No","Yes\nAbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2017-001590-16","EudraCT Number","Change in Progressive Supranuclear Palsy Rating Scale (PSPRS) Total Score from baseline up to 5 years","The PSPRS is a 28-item scale comprising 6 domains (daily activities, mentation, bulbar, ocular motor, limb motor, and gait/midline).","Up to approximately 5 years","Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living)|Change in Clinical Global Impression of Change (CGI-C)|Change in Schwab and England Activities of Daily Living Scale (SEADL)","The UPDRS is an investigator-used rating tool to follow the longitudinal course of Parkinson's disease.|The CGI-C is a clinician's rating of change in disease severity.|The SEADL assesses the subject's ability to perform daily activities.","Up to approximately 5 years","abbvieclinicaltrials@abbvie.com","ABBVIE CALL CENTER","847.283.8955","Calgary, Alberta, Canada, T2N 4Z6|Toronto, Ontario, Canada, M5T 2S8|Montreal, Quebec, Canada, H3A 2B4 Chum - Notre-Dame Hospital /Id# 165461MontrÃ©al, Quebec, Canada, H2X 0A9|Rome, Lazio, Italy, 00168|Rozzano, Milano, Italy, 20089|Turin, Piemonte, Italy, 10126|Catanzaro, Italy, 88100 Fondazione Irccs Istituto Neur /Id# 208737Milan, Italy, 20133 Istituto Neuro Mediterraneo Ir /Id# 165533Pozzilli, Italy, 86077 A.O. Santa Maria /Id# 165535Terni, Italy, 05100 Irccs San Camillo /Id# 201229Venice, Italy, 30126|Birmingham, Alabama, United States, 35294|Phoenix, Arizona, United States, 85054|Beverly Hills, California, United States, 90211 Usc /Id# 165529Los Angeles, California, United States, 90033 University Of California, Los Angeles /Id# 165669Los Angeles, California, United States, 90095 University Of California, San /Id# 165560San Diego, California, United States, 92037 Univ California, San Francisco /Id# 165553San Francisco, California, United States, 94143-2204|Englewood, Colorado, United States, 80113-2736|Gainesville, Florida, United States, 32607 Mayo Clinic /Id# 165554Jacksonville, Florida, United States, 32224 University Of South Florida /Id# 165556Tampa, Florida, United States, 33612|Augusta, Georgia, United States, 30912-0004|Chicago, Illinois, United States, 60612 University Of Chicago Medical /Id# 165555Chicago, Illinois, United States, 60637|Indianapolis, Indiana, United States, 46202|Lexington, Kentucky, United States, 40536|Rochester, Minnesota, United States, 55905-0001|Las Vegas, Nevada, United States, 89106|New Brunswick, New Jersey, United States, 08901|New York, New York, United States, 10032-3725|Cleveland, Ohio, United States, 44195|Portland, Oregon, United States, 97239-3098|Nashville, Tennessee, United States, 37232-0011|Dallas, Texas, United States, 75231-4316 Mcgovern Medical School /Id# 165565Houston, Texas, United States, 77054 Central Texas Neurology Consul /Id# 202223Round Rock, Texas, United States, 78681","Alabama|Arizona|California|Colorado|Florida|Georgia|Illinois|Indiana|Kentucky|Minnesota|Nevada|New Jersey|New York|Ohio|Oregon|Tennessee|Texas","Canada|Italy|United States","Alberta University Of Calgary /Id# 165667|Ontario Toronto Western Hospital /Id# 165462|Quebec Montreal Neurological Institut /Id# 165546|Lazio Ao Univ Policlinico Agostino G /Id# 165536|Milano Istituto Clinico Humanitas /Id# 165531|Piemonte Aou Citta Della Salute Scienza /Id# 208736|University Of Catanzaro /Id# 170214|Univ Alabama-Birmingham /Id# 165522|Mayo Clinic Arizona /Id# 165521|Cedars-Sinai Medical Center /Id# 165567|Rocky Mountain Movement Disorders Center /Id# 165559|Uf Center For Movement Disorde /Id# 165561|Augusta University Medical Center /Id# 165562|Rush University Medical Center /Id# 165527|Indiana University /Id# 165519|University Of Kentucky Chandler Medical Center /Id# 165566|Mayo Clinic - Rochester /Id# 165518|Cleveland Clinic Lou Ruvo Cent /Id# 165538|Rutgers Robert Wood Johnson /Id# 165526|Columbia Univ Medical Center /Id# 165528|Cleveland Clinic Foundation /Id# 165537|Oregon Health And Science University /Id# 165564|Vanderbilt Univ Med Ctr /Id# 165520|Kerwin Research Center /Id# 206872",{"$nulls":3},"AbbVie Inc.","2018-10-09","2020-05-25T16:35:22.661","2020-05-26T17:10:42.972","NCT03391765"]
["5ecbf3ca11702c1b1b9169c6","NCT03391765","2018-11-14","AbbVie","ABBV","Recruiting","An Extension Study of ABBV-8E12 in Progressive Supranuclear Palsy (PSP)","Abbv-8e12",null,"Yes","['Abbv-8e12']","Unknown",null,"Phase 2",2,330,"Anticipated","2018-01-24","2022-09-26",{"$nulls":5},"The purpose of this study is to assess the long-term safety and efficacy of ABBV-8E12 in subjects with progressive supranuclear palsy (PSP).",null,"An Extension Study of ABBV-8E12 in Progressive Supranuclear Palsy (PSP)","M15-563","Progressive Supranuclear Palsy (PSP)","Supranuclear Palsy, Progressive","Central Nervous System Diseases","Central Nervous System","Experimental","Group 2|Group 1","Dose 2 ABBV-8E12|Dose 1 ABBV-8E12","Drug","ABBV-8E12","ABBV-8E12 solution for IV infusion",null,"Group 2|Group 1","\n\n * Subject completed the 52-week treatment period in Study M15-562 (NCT02985879).\n * In the opinion of the investigator, the subject was compliant during participation in Study M15-562 (NCT02985879).\n * Subject has an identified, reliable, study partner (e.g., caregiver, family member, social worker, or friend).\n\n","\n\n * Subjects who weigh less than 44 kg (97 lbs) at the time of study entry.\n * Any contraindication or inability to tolerate brain magnetic resonance imaging (MRI).\n * Subject has any significant change in his/her medical condition that could interfere with the subject's participation in the study, could place the subject at increased risk, or could confound interpretation of study results.\n * More than 8 weeks have elapsed since the subject received his/her last dose of study drug in Study M15-562 (NCT02985879).\n * Subject is considered by the investigator, for any reason, to be an unsuitable candidate to receive ABBV-8E12 or the subject is considered by the investigator to be unable or unlikely to comply with the dosing schedule or study evaluations.",{"$nulls":4},"Actual","2018-01-05","Actual","Anticipated","2022-09-26","Anticipated","2018-11-01","2018-01-02","2018-01-02","2018-11-13","Yes","tauopathy\nSteele-Richardson-Olszewski Syndrome\nPSP","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","40 Years",null,"All",null,"No","Yes\nAbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2017-001590-16","EudraCT Number","Change in Progressive Supranuclear Palsy Rating Scale (PSPRS) Total Score from baseline up to 5 years","The PSPRS is a 28-item scale comprising 6 domains (daily activities, mentation, bulbar, ocular motor, limb motor, and gait/midline).","Up to approximately 5 years","Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living)|Change in Clinical Global Impression of Change (CGI-C)|Change in Schwab and England Activities of Daily Living Scale (SEADL)","The UPDRS is an investigator-used rating tool to follow the longitudinal course of Parkinson's disease.|The CGI-C is a clinician's rating of change in disease severity.|The SEADL assesses the subject's ability to perform daily activities.","Up to approximately 5 years","abbvieclinicaltrials@abbvie.com","ABBVIE CALL CENTER","847.283.8955","Calgary, Alberta, Canada, T2N 4Z6|Toronto, Ontario, Canada, M5T 2S8|Montreal, Quebec, Canada, H3A 2B4 Chum - Notre-Dame Hospital /Id# 165461MontrÃ©al, Quebec, Canada, H2X 0A9|Rome, Lazio, Italy, 00168|Rozzano, Milano, Italy, 20089|Catanzaro, Italy, 88100 Fondazione Irccs Istituto Neur /Id# 208737Milan, Italy, 20133 Istituto Neuro Mediterraneo Ir /Id# 165533Pozzilli, Italy, 86077 A.O. Santa Maria /Id# 165535Terni, Italy, 05100 Irccs San Camillo /Id# 201229Venice, Italy, 30126|Birmingham, Alabama, United States, 35294|Phoenix, Arizona, United States, 85054|Beverly Hills, California, United States, 90211 Usc /Id# 165529Los Angeles, California, United States, 90033 University Of California, Los Angeles /Id# 165669Los Angeles, California, United States, 90095 University Of California, San /Id# 165560San Diego, California, United States, 92037 Univ California, San Francisco /Id# 165553San Francisco, California, United States, 94143-2204|Englewood, Colorado, United States, 80113-2736|Gainesville, Florida, United States, 32607 Mayo Clinic /Id# 165554Jacksonville, Florida, United States, 32224 University Of South Florida /Id# 165556Tampa, Florida, United States, 33612|Augusta, Georgia, United States, 30912-0004|Chicago, Illinois, United States, 60612 University Of Chicago Medical /Id# 165555Chicago, Illinois, United States, 60637|Indianapolis, Indiana, United States, 46202|Lexington, Kentucky, United States, 40536|Rochester, Minnesota, United States, 55905-0001|Las Vegas, Nevada, United States, 89106|New Brunswick, New Jersey, United States, 08901|New York, New York, United States, 10032-3725|Cleveland, Ohio, United States, 44195|Portland, Oregon, United States, 97239-3098|Nashville, Tennessee, United States, 37232-0011|Dallas, Texas, United States, 75231-4316 Mcgovern Medical School /Id# 165565Houston, Texas, United States, 77054 Central Texas Neurology Consul /Id# 202223Round Rock, Texas, United States, 78681","Alabama|Arizona|California|Colorado|Florida|Georgia|Illinois|Indiana|Kentucky|Minnesota|Nevada|New Jersey|New York|Ohio|Oregon|Tennessee|Texas","Canada|Italy|United States","Alberta University Of Calgary /Id# 165667|Ontario Toronto Western Hospital /Id# 165462|Quebec Montreal Neurological Institut /Id# 165546|Lazio Ao Univ Policlinico Agostino G /Id# 165536|Milano Istituto Clinico Humanitas /Id# 165531|University Of Catanzaro /Id# 170214|Univ Alabama-Birmingham /Id# 165522|Mayo Clinic Arizona /Id# 165521|Cedars-Sinai Medical Center /Id# 165567|Rocky Mountain Movement Disorders Center /Id# 165559|Uf Center For Movement Disorde /Id# 165561|Augusta University Medical Center /Id# 165562|Rush University Medical Center /Id# 165527|Indiana University /Id# 165519|University Of Kentucky Chandler Medical Center /Id# 165566|Mayo Clinic - Rochester /Id# 165518|Cleveland Clinic Lou Ruvo Cent /Id# 165538|Rutgers Robert Wood Johnson /Id# 165526|Columbia Univ Medical Center /Id# 165528|Cleveland Clinic Foundation /Id# 165537|Oregon Health And Science University /Id# 165564|Vanderbilt Univ Med Ctr /Id# 165520|Kerwin Research Center /Id# 206872",{"$nulls":3},"AbbVie Inc.","2018-11-13","2020-05-25T16:35:22.341","2020-05-26T17:10:42.972","NCT03391765"]
["5ecbf3cafe30261b1a0481b3","NCT03391765","2018-11-23","AbbVie","ABBV","Enrolling by invitation","An Extension Study of ABBV-8E12 in Progressive Supranuclear Palsy (PSP)","Abbv-8e12",null,"Yes","['Abbv-8e12']","Unknown",null,"Phase 2",2,330,"Anticipated","2018-01-24","2022-09-26",{"$nulls":5},"The purpose of this study is to assess the long-term safety and efficacy of ABBV-8E12 in subjects with progressive supranuclear palsy (PSP).",null,"An Extension Study of ABBV-8E12 in Progressive Supranuclear Palsy (PSP)","M15-563","Progressive Supranuclear Palsy (PSP)","Supranuclear Palsy, Progressive","Central Nervous System Diseases","Central Nervous System","Experimental","Group 2|Group 1","Dose 2 ABBV-8E12|Dose 1 ABBV-8E12","Drug","ABBV-8E12","ABBV-8E12 solution for IV infusion",null,"Group 2|Group 1","\n\n * Subject completed the 52-week treatment period in Study M15-562 (NCT02985879).\n * In the opinion of the investigator, the subject was compliant during participation in Study M15-562 (NCT02985879).\n * Subject has an identified, reliable, study partner (e.g., caregiver, family member, social worker, or friend).\n\n","\n\n * Subjects who weigh less than 44 kg (97 lbs) at the time of study entry.\n * Any contraindication or inability to tolerate brain magnetic resonance imaging (MRI).\n * Subject has any significant change in his/her medical condition that could interfere with the subject's participation in the study, could place the subject at increased risk, or could confound interpretation of study results.\n * More than 8 weeks have elapsed since the subject received his/her last dose of study drug in Study M15-562 (NCT02985879).\n * Subject is considered by the investigator, for any reason, to be an unsuitable candidate to receive ABBV-8E12 or the subject is considered by the investigator to be unable or unlikely to comply with the dosing schedule or study evaluations.",{"$nulls":4},"Actual","2018-01-05","Actual","Anticipated","2022-09-26","Anticipated","2018-11-01","2018-01-02","2018-01-02","2018-11-21","Yes","tauopathy\nSteele-Richardson-Olszewski Syndrome\nPSP","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","40 Years",null,"All",null,"No","Yes\nAbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2017-001590-16","EudraCT Number","Change in Progressive Supranuclear Palsy Rating Scale (PSPRS) Total Score from baseline up to 5 years","The PSPRS is a 28-item scale comprising 6 domains (daily activities, mentation, bulbar, ocular motor, limb motor, and gait/midline).","Up to approximately 5 years","Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living)|Change in Clinical Global Impression of Change (CGI-C)|Change in Schwab and England Activities of Daily Living Scale (SEADL)","The UPDRS is an investigator-used rating tool to follow the longitudinal course of Parkinson's disease.|The CGI-C is a clinician's rating of change in disease severity.|The SEADL assesses the subject's ability to perform daily activities.","Up to approximately 5 years",{"$nulls":3},"Calgary, Alberta, Canada, T2N 4Z6|Toronto, Ontario, Canada, M5T 2S8|Montreal, Quebec, Canada, H3A 2B4 Chum - Notre-Dame Hospital /Id# 165461MontrÃ©al, Quebec, Canada, H2X 0A9|Rome, Lazio, Italy, 00168|Rozzano, Milano, Italy, 20089|Catanzaro, Italy, 88100 Fondazione Irccs Istituto Neur /Id# 208737Milan, Italy, 20133 Istituto Neuro Mediterraneo Ir /Id# 165533Pozzilli, Italy, 86077 A.O. Santa Maria /Id# 165535Terni, Italy, 05100 Irccs San Camillo /Id# 201229Venice, Italy, 30126|Birmingham, Alabama, United States, 35294|Phoenix, Arizona, United States, 85054|Beverly Hills, California, United States, 90211 Usc /Id# 165529Los Angeles, California, United States, 90033 University Of California, Los Angeles /Id# 165669Los Angeles, California, United States, 90095 University Of California, San /Id# 165560San Diego, California, United States, 92037 Univ California, San Francisco /Id# 165553San Francisco, California, United States, 94143-2204|Englewood, Colorado, United States, 80113-2736|Gainesville, Florida, United States, 32607 Mayo Clinic /Id# 165554Jacksonville, Florida, United States, 32224 University Of South Florida /Id# 165556Tampa, Florida, United States, 33612|Augusta, Georgia, United States, 30912-0004|Chicago, Illinois, United States, 60612 University Of Chicago Medical /Id# 165555Chicago, Illinois, United States, 60637|Indianapolis, Indiana, United States, 46202|Lexington, Kentucky, United States, 40536|Rochester, Minnesota, United States, 55905-0001|Las Vegas, Nevada, United States, 89106|New Brunswick, New Jersey, United States, 08901|New York, New York, United States, 10032-3725|Cleveland, Ohio, United States, 44195|Portland, Oregon, United States, 97239-3098|Nashville, Tennessee, United States, 37232-0011|Dallas, Texas, United States, 75231-4316 Mcgovern Medical School /Id# 165565Houston, Texas, United States, 77054 Central Texas Neurology Consul /Id# 202223Round Rock, Texas, United States, 78681","Alabama|Arizona|California|Colorado|Florida|Georgia|Illinois|Indiana|Kentucky|Minnesota|Nevada|New Jersey|New York|Ohio|Oregon|Tennessee|Texas","Canada|Italy|United States","Alberta University Of Calgary /Id# 165667|Ontario Toronto Western Hospital /Id# 165462|Quebec Montreal Neurological Institut /Id# 165546|Lazio Ao Univ Policlinico Agostino G /Id# 165536|Milano Istituto Clinico Humanitas /Id# 165531|University Of Catanzaro /Id# 170214|Univ Alabama-Birmingham /Id# 165522|Mayo Clinic Arizona /Id# 165521|Cedars-Sinai Medical Center /Id# 165567|Rocky Mountain Movement Disorders Center /Id# 165559|Uf Center For Movement Disorde /Id# 165561|Augusta University Medical Center /Id# 165562|Rush University Medical Center /Id# 165527|Indiana University /Id# 165519|University Of Kentucky Chandler Medical Center /Id# 165566|Mayo Clinic - Rochester /Id# 165518|Cleveland Clinic Lou Ruvo Cent /Id# 165538|Rutgers Robert Wood Johnson /Id# 165526|Columbia Univ Medical Center /Id# 165528|Cleveland Clinic Foundation /Id# 165537|Oregon Health And Science University /Id# 165564|Vanderbilt Univ Med Ctr /Id# 165520|Kerwin Research Center /Id# 206872",{"$nulls":3},"AbbVie Inc.","2018-11-21","2020-05-25T16:35:22.661","2020-05-26T17:10:42.972","NCT03391765"]
["5ecbf3ca307e3d1b1f8d9c43","NCT03391765","2019-03-04","AbbVie","ABBV","Enrolling by invitation","An Extension Study of ABBV-8E12 in Progressive Supranuclear Palsy (PSP)","Abbv-8e12",null,"Yes","['Abbv-8e12']","Unknown",null,"Phase 2",2,330,"Anticipated","2018-01-24","2022-09-22",{"$nulls":5},"The purpose of this study is to assess the long-term safety and efficacy of ABBV-8E12 in subjects with progressive supranuclear palsy (PSP).",null,"An Extension Study of ABBV-8E12 in Progressive Supranuclear Palsy (PSP)","M15-563","Progressive Supranuclear Palsy (PSP)","Supranuclear Palsy, Progressive","Central Nervous System Diseases","Central Nervous System","Experimental","Group 2|Group 1","Dose 2 ABBV-8E12|Dose 1 ABBV-8E12","Drug","ABBV-8E12","ABBV-8E12 solution for IV infusion",null,"Group 2|Group 1","\n\n * Subject completed the 52-week treatment period in Study M15-562 (NCT02985879).\n * In the opinion of the investigator, the subject was compliant during participation in Study M15-562 (NCT02985879).\n * Subject has an identified, reliable, study partner (e.g., caregiver, family member, social worker, or friend).\n\n","\n\n * Subjects who weigh less than 44 kg (97 lbs) at the time of study entry.\n * Any contraindication or inability to tolerate brain magnetic resonance imaging (MRI).\n * Subject has any significant change in his/her medical condition that could interfere with the subject's participation in the study, could place the subject at increased risk, or could confound interpretation of study results.\n * More than 8 weeks have elapsed since the subject received his/her last dose of study drug in Study M15-562 (NCT02985879).\n * Subject is considered by the investigator, for any reason, to be an unsuitable candidate to receive ABBV-8E12 or the subject is considered by the investigator to be unable or unlikely to comply with the dosing schedule or study evaluations.",{"$nulls":4},"Actual","2018-01-05","Actual","Anticipated","2022-09-22","Anticipated","2019-03-01","2018-01-02","2018-01-02","2019-03-01","Yes","tauopathy\nSteele-Richardson-Olszewski Syndrome\nPSP","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","40 Years",null,"All",null,"No","Yes\nAbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2017-001590-16","EudraCT Number","Change in Progressive Supranuclear Palsy Rating Scale (PSPRS) Total Score from baseline up to 5 years","The PSPRS is a 28-item scale comprising 6 domains (daily activities, mentation, bulbar, ocular motor, limb motor, and gait/midline).","Up to approximately 5 years","Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living)|Change in Clinical Global Impression of Change (CGI-C)|Change in Schwab and England Activities of Daily Living Scale (SEADL)","The UPDRS is an investigator-used rating tool to follow the longitudinal course of Parkinson's disease.|The CGI-C is a clinician's rating of change in disease severity.|The SEADL assesses the subject's ability to perform daily activities.","Up to approximately 5 years",{"$nulls":3},"Westmead, New South Wales, Australia, 2145|Adelaide, South|Melbourne, Victoria, Australia, 3004|Calgary, Alberta, Canada, T2N 4Z6|Toronto, Ontario, Canada, M5T 2S8|Montreal, Quebec, Canada, H3A 2B4 Chum - Notre-Dame Hospital /Id# 165461MontrÃ©al, Quebec, Canada, H2X 0A9|Rome, Lazio, Italy, 00168|Rozzano, Milano, Italy, 20089|Catanzaro, Italy, 88100 Fondazione Irccs Istituto Neurologico Carlo Besta /Id# 208737Milan, Italy, 20133 Istituto Neuro Mediterraneo Ir /Id# 165533Pozzilli, Italy, 86077 A.O. Santa Maria /Id# 165535Terni, Italy, 05100 Irccs San Camillo /Id# 201229Venice, Italy, 30126|Birmingham, Alabama, United States, 35294|Phoenix, Arizona, United States, 85054|Beverly Hills, California, United States, 90211 Usc /Id# 165529Los Angeles, California, United States, 90033 University Of California, Los Angeles /Id# 165669Los Angeles, California, United States, 90095 University Of California, San /Id# 165560San Diego, California, United States, 92037 Univ California, San Francisco /Id# 165553San Francisco, California, United States, 94143-2204|Englewood, Colorado, United States, 80113-2736|Gainesville, Florida, United States, 32607 Mayo Clinic /Id# 165554Jacksonville, Florida, United States, 32224 University Of South Florida /Id# 165556Tampa, Florida, United States, 33612|Augusta, Georgia, United States, 30912-0004|Chicago, Illinois, United States, 60612 University Of Chicago Medical /Id# 165555Chicago, Illinois, United States, 60637|Indianapolis, Indiana, United States, 46202|Lexington, Kentucky, United States, 40536|Rochester, Minnesota, United States, 55905-0001|Las Vegas, Nevada, United States, 89106|New Brunswick, New Jersey, United States, 08901|New York, New York, United States, 10032-3725|Cleveland, Ohio, United States, 44195|Portland, Oregon, United States, 97239-3098|Nashville, Tennessee, United States, 37232-0011|Dallas, Texas, United States, 75231-4316 Mcgovern Medical School /Id# 165565Houston, Texas, United States, 77054 Central Texas Neurology Consul /Id# 202223Round Rock, Texas, United States, 78681","Alabama|Arizona|California|Colorado|Florida|Georgia|Illinois|Indiana|Kentucky|Minnesota|Nevada|New Jersey|New York|Ohio|Oregon|Tennessee|Texas","Australia|Canada|Italy|United States","New South Wales Westmead Hospital /Id# 170218|Royal Adelaide Hospital /Id# 165451|Victoria Alfred Hospital /Id# 165454|Alberta University Of Calgary /Id# 165667|Ontario Toronto Western Hospital /Id# 165462|Quebec Montreal Neurological Institut /Id# 165546|Lazio Ao Univ Policlinico Agostino G /Id# 165536|Milano Istituto Clinico Humanitas /Id# 165531|University Of Catanzaro /Id# 170214|Univ Alabama-Birmingham /Id# 165522|Mayo Clinic Arizona /Id# 165521|Cedars-Sinai Medical Center /Id# 165567|Rocky Mountain Movement Disorders Center /Id# 165559|Uf Center For Movement Disorde /Id# 165561|Augusta University Medical Center /Id# 165562|Rush University Medical Center /Id# 165527|Indiana University /Id# 165519|University Of Kentucky Chandler Medical Center /Id# 165566|Mayo Clinic - Rochester /Id# 165518|Cleveland Clinic Lou Ruvo Cent /Id# 165538|Rutgers Robert Wood Johnson /Id# 165526|Columbia Univ Medical Center /Id# 165528|Cleveland Clinic Foundation /Id# 165537|Oregon Health And Science University /Id# 165564|Vanderbilt Univ Med Ctr /Id# 165520|Kerwin Research Center /Id# 206872",{"$nulls":3},"AbbVie Inc.","2019-03-01","2020-05-25T16:35:22.394","2020-05-26T17:10:42.972","NCT03391765"]
["5ecbf3cae2561b1b11905caf","NCT03391765","2019-03-21","AbbVie","ABBV","Recruiting","An Extension Study of ABBV-8E12 in Progressive Supranuclear Palsy (PSP)","Abbv-8e12",null,"Yes","['Abbv-8e12']","Unknown",null,"Phase 2",2,378,"Anticipated","2018-01-24","2022-09-22",{"$nulls":5},"The purpose of this study is to assess the long-term safety and efficacy of ABBV-8E12 in subjects with progressive supranuclear palsy (PSP). In a subset of participants at participating sites, participants will be assigned digital sensor BioStamp to assess body position and gait.",null,"An Extension Study of ABBV-8E12 in Progressive Supranuclear Palsy (PSP)","M15-563","Progressive Supranuclear Palsy (PSP)","Supranuclear Palsy, Progressive","Central Nervous System Diseases","Central Nervous System","Experimental","Group 2|Group 1","Dose 2 ABBV-8E12|Dose 1 ABBV-8E12","Drug","ABBV-8E12","ABBV-8E12 solution for IV infusion",null,"Group 2|Group 1","\n\n * Subject completed the 52-week treatment period in Study M15-562 (NCT02985879).\n * In the opinion of the investigator, the subject was compliant during participation in Study M15-562 (NCT02985879).\n * Subject has an identified, reliable, study partner (e.g., caregiver, family member, social worker, or friend).\n\n","\n\n * Subjects who weigh less than 44 kg (97 lbs) at the time of study entry.\n * Any contraindication or inability to tolerate brain magnetic resonance imaging (MRI).\n * Subject has any significant change in his/her medical condition that could interfere with the subject's participation in the study, could place the subject at increased risk, or could confound interpretation of study results.\n * More than 8 weeks have elapsed since the subject received his/her last dose of study drug in Study M15-562 (NCT02985879).\n * Subject is considered by the investigator, for any reason, to be an unsuitable candidate to receive ABBV-8E12 or the subject is considered by the investigator to be unable or unlikely to comply with the dosing schedule or study evaluations.",{"$nulls":4},"Actual","2018-01-05","Actual","Anticipated","2022-09-22","Anticipated","2019-03-01","2018-01-02","2018-01-02","2019-03-19","Yes","tauopathy\nSteele-Richardson-Olszewski Syndrome\nPSP","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","40 Years",null,"All",null,"No","Yes\nAbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2017-001590-16","EudraCT Number","Change in Progressive Supranuclear Palsy Rating Scale (PSPRS) Total Score from baseline up to 5 years","The PSPRS is a 28-item scale comprising 6 domains (daily activities, mentation, bulbar, ocular motor, limb motor, and gait/midline).","Up to approximately 5 years","Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living)|Change in Clinical Global Impression of Change (CGI-C)|Change in Schwab and England Activities of Daily Living Scale (SEADL)","The UPDRS is an investigator-used rating tool to follow the longitudinal course of Parkinson's disease.|The CGI-C is a clinician's rating of change in disease severity.|The SEADL assesses the subject's ability to perform daily activities.","Up to approximately 5 years","abbvieclinicaltrials@abbvie.com","ABBVIE CALL CENTER","847.283.8955","Westmead, New South Wales, Australia, 2145|Adelaide, South|Melbourne, Victoria, Australia, 3004|Calgary, Alberta, Canada, T2N 4Z6|Toronto, Ontario, Canada, M5T 2S8|Montreal, Quebec, Canada, H3A 2B4 Chum - Notre-Dame Hospital /Id# 165461MontrÃ©al, Quebec, Canada, H2X 0A9|Rome, Lazio, Italy, 00168|Rozzano, Milano, Italy, 20089|Catanzaro, Italy, 88100 Fondazione Irccs Istituto Neurologico Carlo Besta /Id# 208737Milan, Italy, 20133 Istituto Neuro Mediterraneo Ir /Id# 165533Pozzilli, Italy, 86077 A.O. Santa Maria /Id# 165535Terni, Italy, 05100 Irccs San Camillo /Id# 201229Venice, Italy, 30126|Kyoto City, Kyoto, Japan, 616-8255|Suita-Shi, Osaka, Japan, 565-0871|Birmingham, Alabama, United States, 35294|Phoenix, Arizona, United States, 85054|Beverly Hills, California, United States, 90211 Usc /Id# 165529Los Angeles, California, United States, 90033 University Of California, Los Angeles /Id# 165669Los Angeles, California, United States, 90095 University Of California, San /Id# 165560San Diego, California, United States, 92037 Univ California, San Francisco /Id# 165553San Francisco, California, United States, 94143-2204|Englewood, Colorado, United States, 80113-2736|Gainesville, Florida, United States, 32607 Mayo Clinic /Id# 165554Jacksonville, Florida, United States, 32224 University Of South Florida /Id# 165556Tampa, Florida, United States, 33612|Augusta, Georgia, United States, 30912-0004|Chicago, Illinois, United States, 60612 University Of Chicago Medical /Id# 165555Chicago, Illinois, United States, 60637|Indianapolis, Indiana, United States, 46202|Lexington, Kentucky, United States, 40536|Rochester, Minnesota, United States, 55905-0001|Las Vegas, Nevada, United States, 89106|New Brunswick, New Jersey, United States, 08901|New York, New York, United States, 10032-3725|Cleveland, Ohio, United States, 44195|Portland, Oregon, United States, 97239-3098|Nashville, Tennessee, United States, 37232-0011|Dallas, Texas, United States, 75231-4316 Mcgovern Medical School /Id# 165565Houston, Texas, United States, 77054 Central Texas Neurology Consul /Id# 202223Round Rock, Texas, United States, 78681","Alabama|Arizona|California|Colorado|Florida|Georgia|Illinois|Indiana|Kentucky|Minnesota|Nevada|New Jersey|New York|Ohio|Oregon|Tennessee|Texas","Australia|Canada|Italy|Japan|United States","New South Wales Westmead Hospital /Id# 170218|Royal Adelaide Hospital /Id# 165451|Victoria Alfred Hospital /Id# 165454|Alberta University Of Calgary /Id# 165667|Ontario Toronto Western Hospital /Id# 165462|Quebec Montreal Neurological Institut /Id# 165546|Lazio Ao Univ Policlinico Agostino G /Id# 165536|Milano Istituto Clinico Humanitas /Id# 165531|University Of Catanzaro /Id# 170214|Kyoto Nho Utano Hospital /Id# 208780|Osaka Osaka University Hospital /Id# 208787|Univ Alabama-Birmingham /Id# 165522|Mayo Clinic Arizona /Id# 165521|Cedars-Sinai Medical Center /Id# 165567|Rocky Mountain Movement Disorders Center /Id# 165559|Uf Center For Movement Disorde /Id# 165561|Augusta University Medical Center /Id# 165562|Rush University Medical Center /Id# 165527|Indiana University /Id# 165519|University Of Kentucky Chandler Medical Center /Id# 165566|Mayo Clinic - Rochester /Id# 165518|Cleveland Clinic Lou Ruvo Cent /Id# 165538|Rutgers Robert Wood Johnson /Id# 165526|Columbia Univ Medical Center /Id# 165528|Cleveland Clinic Foundation /Id# 165537|Oregon Health And Science University /Id# 165564|Vanderbilt Univ Med Ctr /Id# 165520|Kerwin Research Center /Id# 206872",{"$nulls":3},"AbbVie Inc.","2019-03-19","2020-05-25T16:35:22.806","2020-05-26T17:10:42.972","NCT03391765"]
["5ecbf3cbfeab101b155307e4","NCT03391765","2019-05-30","AbbVie","ABBV","Enrolling by invitation","An Extension Study of ABBV-8E12 in Progressive Supranuclear Palsy (PSP)","Abbv-8e12",null,"Yes","['Abbv-8e12']","Unknown",null,"Phase 2",2,378,"Anticipated","2018-01-24","2022-09-22",{"$nulls":5},"The purpose of this study is to assess the long-term safety and efficacy of ABBV-8E12 in subjects with progressive supranuclear palsy (PSP). In a subset of participants at participating sites, participants will be assigned digital sensor BioStamp to assess body position and gait.",null,"An Extension Study of ABBV-8E12 in Progressive Supranuclear Palsy (PSP)","M15-563","Progressive Supranuclear Palsy (PSP)","Supranuclear Palsy, Progressive","Central Nervous System Diseases","Central Nervous System","Experimental","Group 2|Group 1","Dose 2 ABBV-8E12|Dose 1 ABBV-8E12","Drug","ABBV-8E12","ABBV-8E12 solution for IV infusion",null,"Group 2|Group 1","\n\n * Subject completed the 52-week treatment period in Study M15-562 (NCT02985879).\n * In the opinion of the investigator, the subject was compliant during participation in Study M15-562 (NCT02985879).\n * Subject has an identified, reliable, study partner (e.g., caregiver, family member, social worker, or friend).\n\n","\n\n * Subjects who weigh less than 44 kg (97 lbs) at the time of study entry.\n * Any contraindication or inability to tolerate brain magnetic resonance imaging (MRI).\n * Subject has any significant change in his/her medical condition that could interfere with the subject's participation in the study, could place the subject at increased risk, or could confound interpretation of study results.\n * More than 8 weeks have elapsed since the subject received his/her last dose of study drug in Study M15-562 (NCT02985879).\n * Subject is considered by the investigator, for any reason, to be an unsuitable candidate to receive ABBV-8E12 or the subject is considered by the investigator to be unable or unlikely to comply with the dosing schedule or study evaluations.",{"$nulls":4},"Actual","2018-01-05","Actual","Anticipated","2022-09-22","Anticipated","2019-05-01","2018-01-02","2018-01-02","2019-05-28","Yes","tauopathy\nSteele-Richardson-Olszewski Syndrome\nPSP","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","40 Years",null,"All",null,"No","Yes\nAbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2017-001590-16","EudraCT Number","Change in Progressive Supranuclear Palsy Rating Scale (PSPRS) Total Score from baseline up to 5 years","The PSPRS is a 28-item scale comprising 6 domains (daily activities, mentation, bulbar, ocular motor, limb motor, and gait/midline).","Up to approximately 5 years","Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living)|Change in Clinical Global Impression of Change (CGI-C)|Change in Schwab and England Activities of Daily Living Scale (SEADL)","The UPDRS is an investigator-used rating tool to follow the longitudinal course of Parkinson's disease.|The CGI-C is a clinician's rating of change in disease severity.|The SEADL assesses the subject's ability to perform daily activities.","Up to approximately 5 years",{"$nulls":3},"Westmead, New South Wales, Australia, 2145|Adelaide, South|Melbourne, Victoria, Australia, 3004|Calgary, Alberta, Canada, T2N 4Z6|Toronto, Ontario, Canada, M5T 2S8|Montreal, Quebec, Canada, H3A 2B4 Chum - Notre-Dame Hospital /Id# 165461MontrÃ©al, Quebec, Canada, H2X 0A9|Rome, Lazio, Italy, 00168|Rozzano, Milano, Italy, 20089|Catanzaro, Italy, 88100 Fondazione Irccs Istituto Neurologico Carlo Besta /Id# 208737Milan, Italy, 20133 Istituto Neuro Mediterraneo Ir /Id# 165533Pozzilli, Italy, 86077 A.O. Santa Maria /Id# 165535Terni, Italy, 05100 Irccs San Camillo /Id# 201229Venice, Italy, 30126|Kyoto City, Kyoto, Japan, 616-8255|Suita-Shi, Osaka, Japan, 565-0871|Birmingham, Alabama, United States, 35294|Phoenix, Arizona, United States, 85054|Beverly Hills, California, United States, 90211 Usc /Id# 165529Los Angeles, California, United States, 90033 University Of California, Los Angeles /Id# 165669Los Angeles, California, United States, 90095 University Of California, San /Id# 165560San Diego, California, United States, 92037 Univ California, San Francisco /Id# 165553San Francisco, California, United States, 94143-2204|Englewood, Colorado, United States, 80113-2736|Gainesville, Florida, United States, 32607 Mayo Clinic /Id# 165554Jacksonville, Florida, United States, 32224 University Of South Florida /Id# 165556Tampa, Florida, United States, 33612|Augusta, Georgia, United States, 30912-0004|Chicago, Illinois, United States, 60612 University Of Chicago Medical /Id# 165555Chicago, Illinois, United States, 60637|Indianapolis, Indiana, United States, 46202|Lexington, Kentucky, United States, 40536|Rochester, Minnesota, United States, 55905-0001|Las Vegas, Nevada, United States, 89106|New Brunswick, New Jersey, United States, 08901|New York, New York, United States, 10032-3725|Cleveland, Ohio, United States, 44195|Portland, Oregon, United States, 97239-3098|Nashville, Tennessee, United States, 37232-0011|Dallas, Texas, United States, 75231-4316 Mcgovern Medical School /Id# 165565Houston, Texas, United States, 77054 Central Texas Neurology Consul /Id# 202223Round Rock, Texas, United States, 78681","Alabama|Arizona|California|Colorado|Florida|Georgia|Illinois|Indiana|Kentucky|Minnesota|Nevada|New Jersey|New York|Ohio|Oregon|Tennessee|Texas","Australia|Canada|Italy|Japan|United States","New South Wales Westmead Hospital /Id# 170218|Royal Adelaide Hospital /Id# 165451|Victoria Alfred Hospital /Id# 165454|Alberta University Of Calgary /Id# 165667|Ontario Toronto Western Hospital /Id# 165462|Quebec Montreal Neurological Institut /Id# 165546|Lazio Ao Univ Policlinico Agostino G /Id# 165536|Milano Istituto Clinico Humanitas /Id# 165531|University Of Catanzaro /Id# 170214|Kyoto Nho Utano Hospital /Id# 208780|Osaka Osaka University Hospital /Id# 208787|Univ Alabama-Birmingham /Id# 165522|Mayo Clinic Arizona /Id# 165521|Cedars-Sinai Medical Center /Id# 165567|Rocky Mountain Movement Disorders Center /Id# 165559|Uf Center For Movement Disorde /Id# 165561|Augusta University Medical Center /Id# 165562|Rush University Medical Center /Id# 165527|Indiana University /Id# 165519|University Of Kentucky Chandler Medical Center /Id# 165566|Mayo Clinic - Rochester /Id# 165518|Cleveland Clinic Lou Ruvo Cent /Id# 165538|Rutgers Robert Wood Johnson /Id# 165526|Columbia Univ Medical Center /Id# 165528|Cleveland Clinic Foundation /Id# 165537|Oregon Health And Science University /Id# 165564|Vanderbilt Univ Med Ctr /Id# 165520|Kerwin Research Center /Id# 206872",{"$nulls":3},"AbbVie Inc.","2019-05-28","2020-05-25T16:35:23.059","2020-05-26T17:10:42.972","NCT03391765"]
["5ecbf3ca307e3d1b1f8d9c44","NCT03391765","2019-08-05","AbbVie","ABBV","Active, not recruiting","An Extension Study of ABBV-8E12 in Progressive Supranuclear Palsy (PSP)","Abbv-8e12",null,"Yes","['Abbv-8e12']","Unknown",null,"Phase 2",2,142,"Actual","2018-01-24","2022-09-22",{"$nulls":5},"The purpose of this study is to assess the long-term safety and efficacy of ABBV-8E12 in subjects with progressive supranuclear palsy (PSP). In a subset of participants at participating sites, participants will be assigned digital sensor BioStamp to assess body position and gait.",null,"An Extension Study of ABBV-8E12 in Progressive Supranuclear Palsy (PSP)","M15-563","Progressive Supranuclear Palsy (PSP)","Supranuclear Palsy, Progressive","Central Nervous System Diseases","Central Nervous System","Experimental","Group 2|Group 1","Dose 2 ABBV-8E12|Dose 1 ABBV-8E12","Drug","ABBV-8E12","ABBV-8E12 solution for IV infusion",null,"Group 2|Group 1","\n\n * Subject completed the 52-week treatment period in Study M15-562 (NCT02985879).\n * In the opinion of the investigator, the subject was compliant during participation in Study M15-562 (NCT02985879).\n * Subject has an identified, reliable, study partner (e.g., caregiver, family member, social worker, or friend).\n\n","\n\n * Subjects who weigh less than 44 kg (97 lbs) at the time of study entry.\n * Any contraindication or inability to tolerate brain magnetic resonance imaging (MRI).\n * Subject has any significant change in his/her medical condition that could interfere with the subject's participation in the study, could place the subject at increased risk, or could confound interpretation of study results.\n * More than 8 weeks have elapsed since the subject received his/her last dose of study drug in Study M15-562 (NCT02985879).\n * Subject is considered by the investigator, for any reason, to be an unsuitable candidate to receive ABBV-8E12 or the subject is considered by the investigator to be unable or unlikely to comply with the dosing schedule or study evaluations.",{"$nulls":4},"Actual","2018-01-05","Actual","Anticipated","2022-09-22","Anticipated","2019-08-01","2018-01-02","2018-01-02","2019-08-02","Yes","tauopathy\nSteele-Richardson-Olszewski Syndrome\nPSP","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","40 Years",null,"All",null,"No","Yes\nAbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2017-001590-16","EudraCT Number","Change in Progressive Supranuclear Palsy Rating Scale (PSPRS) Total Score from baseline up to 5 years","The PSPRS is a 28-item scale comprising 6 domains (daily activities, mentation, bulbar, ocular motor, limb motor, and gait/midline).","Up to approximately 5 years","Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living)|Change in Clinical Global Impression of Change (CGI-C)|Change in Schwab and England Activities of Daily Living Scale (SEADL)","The UPDRS is an investigator-used rating tool to follow the longitudinal course of Parkinson's disease.|The CGI-C is a clinician's rating of change in disease severity.|The SEADL assesses the subject's ability to perform daily activities.","Up to approximately 5 years",{"$nulls":3},"Westmead, New South Wales, Australia, 2145|Herston, Queensland, Australia, 4006|Adelaide, South|Melbourne, Victoria, Australia, 3004|Calgary, Alberta, Canada, T2N 4Z6|Toronto, Ontario, Canada, M5T 2S8|Montreal, Quebec, Canada, H3A 2B4 Chum - Notre-Dame Hospital /Id# 165461MontrÃ©al, Quebec, Canada, H2X 0A9|Bordeaux, France, 33076 Chru Lille /Id# 170206Lille, France, 59037 Hopital Pitie Salpetriere /Id# 165548Paris, France, 75651|Toulouse, Haute-Garonne, France, 31059|Marseille Cedex 05, Provence-Alpes-Cote-D Azur, France, 13385|Rome, Lazio, Italy, 00168|Rozzano, Milano, Italy, 20089|Catanzaro, Italy, 88100 Fondazione Irccs Istituto Neurologico Carlo Besta /Id# 208737Milan, Italy, 20133 Istituto Neuro Mediterraneo Ir /Id# 165533Pozzilli, Italy, 86077 A.O. Santa Maria /Id# 165535Terni, Italy, 05100 Irccs San Camillo /Id# 201229Venice, Italy, 30126|Nagoya-Shi, Aichi, Japan, 4658620|Asahikawa, Hokkaido, Japan, 070-8644|Tokyo, Japan, 113-8431|Kyoto City, Kyoto, Japan, 616-8255|Sendai-Shi, Miyagi, Japan, 980-8574 Nho Sendai Nishitaga National Hospital /Id# 209014Sendai, Miyagi, Japan, 982-8555|Niigata-Shi, Niigata, Japan, 951-8520|Suita-Shi, Osaka, Japan, 565-0871|Kodaira, Tokyo, Japan, 187-8551|Birmingham, Alabama, United States, 35294|Phoenix, Arizona, United States, 85054|Beverly Hills, California, United States, 90211 Usc /Id# 165529Los Angeles, California, United States, 90033 University Of California, Los Angeles /Id# 165669Los Angeles, California, United States, 90095 University Of California, San /Id# 165560San Diego, California, United States, 92037 Univ California, San Francisco /Id# 165553San Francisco, California, United States, 94143-2204|Englewood, Colorado, United States, 80113-2736|Gainesville, Florida, United States, 32607 Mayo Clinic /Id# 165554Jacksonville, Florida, United States, 32224 University Of South Florida /Id# 165556Tampa, Florida, United States, 33612|Augusta, Georgia, United States, 30912-0004|Chicago, Illinois, United States, 60612 University Of Chicago Medical /Id# 165555Chicago, Illinois, United States, 60637|Indianapolis, Indiana, United States, 46202|Lexington, Kentucky, United States, 40536|Rochester, Minnesota, United States, 55905-0001|Las Vegas, Nevada, United States, 89106|New Brunswick, New Jersey, United States, 08901|New York, New York, United States, 10032-3725|Cleveland, Ohio, United States, 44195|Portland, Oregon, United States, 97239|Nashville, Tennessee, United States, 37232-0011|Dallas, Texas, United States, 75231-4316 Mcgovern Medical School /Id# 165565Houston, Texas, United States, 77054 Central Texas Neurology Consul /Id# 202223Round Rock, Texas, United States, 78681","Alabama|Arizona|California|Colorado|Florida|Georgia|Illinois|Indiana|Kentucky|Minnesota|Nevada|New Jersey|New York|Ohio|Oregon|Tennessee|Texas","Australia|Canada|France|Italy|Japan|United States","New South Wales Westmead Hospital /Id# 170218|Queensland Q-Pharm Pty Limited /Id# 165452|Royal Adelaide Hospital /Id# 165451|Victoria Alfred Hospital /Id# 165454|Alberta University Of Calgary /Id# 165667|Ontario Toronto Western Hospital /Id# 165462|Quebec Montreal Neurological Institut /Id# 165546|Chu De Bordeaux Hopital /Id# 165547|Haute-Garonne Hopital Universitaire Purpan /Id# 165792|Provence-Alpes-Cote-D Azur Hopital De La Timone /Id# 165549|Lazio Ao Univ Policlinico Agostino G /Id# 165536|Milano Istituto Clinico Humanitas /Id# 165531|University Of Catanzaro /Id# 170214|Aichi National Hospital Organization Higashinagoya National Hospital /Id# 208786|Hokkaido National Hospital Organization Asahikawa Medical Center /Id# 208818|Juntendo University Hospital /Id# 208779|Kyoto National Hospital Organization Utano National Hospital /Id# 208780|Miyagi Tohoku University Hospital /Id# 209015|Niigata Niigata University Medical & Dental Hospital /Id# 208819|Osaka Osaka University Hospital /Id# 208787|Tokyo National Center Of Neurology And Psychiatry /Id# 208820|Univ Alabama-Birmingham /Id# 165522|Mayo Clinic Arizona /Id# 165521|Cedars-Sinai Medical Center /Id# 165567|Rocky Mountain Movement Disorders Center /Id# 165559|Uf Center For Movement Disorde /Id# 165561|Augusta University Medical Center /Id# 165562|Rush University Medical Center /Id# 165527|Indiana University /Id# 165519|University Of Kentucky Chandler Medical Center /Id# 165566|Mayo Clinic - Rochester /Id# 165518|Cleveland Clinic Lou Ruvo Cent /Id# 165538|Rutgers Robert Wood Johnson /Id# 165526|Columbia Univ Medical Center /Id# 165528|Cleveland Clinic Main Campus /Id# 165537|Oregon Health And Science University /Id# 165564|Vanderbilt Univ Med Ctr /Id# 165520|Kerwin Research Center /Id# 206872",{"$nulls":3},"AbbVie Inc.","2019-08-02","2020-05-25T16:35:22.934","2020-05-26T17:10:42.972","NCT03391765"]
["5ecbf3cafe30261b1a0481b4","NCT03391765","2019-12-16","AbbVie","ABBV","Completed","An Extension Study of ABBV-8E12 in Progressive Supranuclear Palsy (PSP)","Abbv-8e12",null,"Yes","['Abbv-8e12']","Unknown",null,"Phase 2",2,143,"Actual","2018-01-24","2019-11-20",{"$nulls":5},"The purpose of this study is to assess the long-term safety and efficacy of ABBV-8E12 in subjects with progressive supranuclear palsy (PSP). In a subset of participants at participating sites, participants will be assigned digital sensor BioStamp to assess body position and gait.",null,"An Extension Study of ABBV-8E12 in Progressive Supranuclear Palsy (PSP)","M15-563","Progressive Supranuclear Palsy (PSP)","Supranuclear Palsy, Progressive","Central Nervous System Diseases","Central Nervous System","Experimental","Group 2|Group 1","Dose 2 ABBV-8E12|Dose 1 ABBV-8E12","Drug","ABBV-8E12","ABBV-8E12 solution for IV infusion","Tilavonemab","Group 2|Group 1","\n\n * Subject completed the 52-week treatment period in Study M15-562 (NCT02985879).\n * In the opinion of the investigator, the subject was compliant during participation in Study M15-562 (NCT02985879).\n * Subject has an identified, reliable, study partner (e.g., caregiver, family member, social worker, or friend).\n\n","\n\n * Subjects who weigh less than 44 kg (97 lbs) at the time of study entry.\n * Any contraindication or inability to tolerate brain magnetic resonance imaging (MRI).\n * Subject has any significant change in his/her medical condition that could interfere with the subject's participation in the study, could place the subject at increased risk, or could confound interpretation of study results.\n * More than 8 weeks have elapsed since the subject received his/her last dose of study drug in Study M15-562 (NCT02985879).\n * Subject is considered by the investigator, for any reason, to be an unsuitable candidate to receive ABBV-8E12 or the subject is considered by the investigator to be unable or unlikely to comply with the dosing schedule or study evaluations.",{"$nulls":4},"Actual","2018-01-05","Actual","Actual","2019-11-20","Actual","2019-12-01","2018-01-02","2018-01-02","2019-12-12","Yes","tauopathy\nSteele-Richardson-Olszewski Syndrome\nPSP","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","40 Years",null,"All",null,"No","Yes\nAbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2017-001590-16","EudraCT Number","Change in Progressive Supranuclear Palsy Rating Scale (PSPRS) Total Score from baseline up to 5 years","The PSPRS is a 28-item scale comprising 6 domains (daily activities, mentation, bulbar, ocular motor, limb motor, and gait/midline).","Up to approximately 5 years","Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living)|Change in Clinical Global Impression of Change (CGI-C)|Change in Schwab and England Activities of Daily Living Scale (SEADL)","The UPDRS is an investigator-used rating tool to follow the longitudinal course of Parkinson's disease.|The CGI-C is a clinician's rating of change in disease severity.|The SEADL assesses the subject's ability to perform daily activities.","Up to approximately 5 years",{"$nulls":3},"Westmead, New South Wales, Australia, 2145|Herston, Queensland, Australia, 4006|Adelaide, South|Melbourne, Victoria, Australia, 3004|Calgary, Alberta, Canada, T2N 4Z6|Toronto, Ontario, Canada, M5T 2S8|Montreal, Quebec, Canada, H3A 2B4 Chum - Notre-Dame Hospital /Id# 165461MontrÃ©al, Quebec, Canada, H2X 0A9|Rome, Lazio, Italy, 00168|Rozzano, Milano, Italy, 20089|Catanzaro, Italy, 88100 Fondazione Irccs Istituto Neurologico Carlo Besta /Id# 208737Milan, Italy, 20133 Istituto Neuro Mediterraneo Ir /Id# 165533Pozzilli, Italy, 86077 A.O. Santa Maria /Id# 165535Terni, Italy, 05100 Irccs San Camillo /Id# 201229Venice, Italy, 30126|Nagoya-Shi, Aichi, Japan, 4658620|Asahikawa, Hokkaido, Japan, 070-8644|Kyoto City, Kyoto, Japan, 616-8255|Sendai-Shi, Miyagi, Japan, 980-8574 Nho Sendai Nishitaga National Hospital /Id# 209014Sendai, Miyagi, Japan, 982-8555|Niigata-Shi, Niigata, Japan, 951-8520|Suita-Shi, Osaka, Japan, 565-0871|Bunkyo-Ku, Tokyo, Japan, 113-8431 National Center Of Neurology And Psychiatry /Id# 208820Kodaira, Tokyo, Japan, 187-8551|Birmingham, Alabama, United States, 35294|Phoenix, Arizona, United States, 85054|Beverly Hills, California, United States, 90211 Usc /Id# 165529Los Angeles, California, United States, 90033 University Of California, Los Angeles /Id# 165669Los Angeles, California, United States, 90095 University Of California, San /Id# 165560San Diego, California, United States, 92037 Univ California, San Francisco /Id# 165553San Francisco, California, United States, 94143-2204|Englewood, Colorado, United States, 80113-2736|Gainesville, Florida, United States, 32607 Mayo Clinic /Id# 165554Jacksonville, Florida, United States, 32224 University Of South Florida /Id# 165556Tampa, Florida, United States, 33612|Augusta, Georgia, United States, 30912-0004|Chicago, Illinois, United States, 60612 University Of Chicago Medical /Id# 165555Chicago, Illinois, United States, 60637|Indianapolis, Indiana, United States, 46202|Lexington, Kentucky, United States, 40536|Rochester, Minnesota, United States, 55905-0001|Las Vegas, Nevada, United States, 89106|New Brunswick, New Jersey, United States, 08901|New York, New York, United States, 10032-3725|Cleveland, Ohio, United States, 44195|Portland, Oregon, United States, 97239|Nashville, Tennessee, United States, 37232-0011|Dallas, Texas, United States, 75231-4316 Mcgovern Medical School /Id# 165565Houston, Texas, United States, 77054 Central Texas Neurology Consul /Id# 202223Round Rock, Texas, United States, 78681","Alabama|Arizona|California|Colorado|Florida|Georgia|Illinois|Indiana|Kentucky|Minnesota|Nevada|New Jersey|New York|Ohio|Oregon|Tennessee|Texas","Australia|Canada|Italy|Japan|United States","New South Wales Westmead Hospital /Id# 170218|Queensland Q-Pharm Pty Limited /Id# 165452|Royal Adelaide Hospital /Id# 165451|Victoria Alfred Hospital /Id# 165454|Alberta University Of Calgary /Id# 165667|Ontario Toronto Western Hospital /Id# 165462|Quebec Montreal Neurological Institut /Id# 165546|Lazio Ao Univ Policlinico Agostino G /Id# 165536|Milano Istituto Clinico Humanitas /Id# 165531|University Of Catanzaro /Id# 170214|Aichi National Hospital Organization Higashinagoya National Hospital /Id# 208786|Hokkaido National Hospital Organization Asahikawa Medical Center /Id# 208818|Kyoto National Hospital Organization Utano National Hospital /Id# 208780|Miyagi Tohoku University Hospital /Id# 209015|Niigata Niigata University Medical & Dental Hospital /Id# 208819|Osaka Osaka University Hospital /Id# 208787|Tokyo Juntendo University Hospital /Id# 208779|Univ Alabama-Birmingham /Id# 165522|Mayo Clinic Arizona /Id# 165521|Cedars-Sinai Medical Center /Id# 165567|Rocky Mountain Movement Disorders Center /Id# 165559|Uf Center For Movement Disorde /Id# 165561|Augusta University Medical Center /Id# 165562|Rush University Medical Center /Id# 165527|Indiana University /Id# 165519|University Of Kentucky Chandler Medical Center /Id# 165566|Mayo Clinic - Rochester /Id# 165518|Cleveland Clinic Lou Ruvo Cent /Id# 165538|Rutgers Robert Wood Johnson /Id# 165526|Weill Cornell Medicine /Id# 165528|Cleveland Clinic Main Campus /Id# 165537|Oregon Health And Science University /Id# 165564|Vanderbilt Univ Med Ctr /Id# 165520|Kerwin Research Center /Id# 206872",{"$nulls":3},"AbbVie Inc.","2019-12-12","2020-05-25T16:35:22.923","2020-05-26T17:10:42.972","NCT03391765"]
["5ecbf3cb11702c1b1b9169c8","NCT03391778","2018-01-05","Adaptimmune","ADAP","Not yet recruiting","Long Term Follow up of Subjects Exposed to NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T","Ny-eso-1","Vaccine","Yes","['Ny-eso-1']","Yes","['Vaccine']",null,null,300,"Anticipated","2018-01-01","2047-05-01",{"$nulls":5},"Patients who were previously treated with Adaptimmune NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T cells are asked to take part in this study to see how safe NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T cells are and what side effects they might cause over 15 years. Patients will not be treated with NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T cells as part of this study.\n\nFor a period of 15 years starting from last treatment with NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T cells, patients will visit their study doctor to have their blood checked for any changes that might have happened because of the NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T cells. Patients can receive other therapies for their cancer while they are being followed for long term safety in this study.","This is a non-therapeutic, multi-center, long-term follow-up (LTFU) study of subjects who have, in a previous Adaptimmune clinical trial, received NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T by a process that utilizes lentiviral vectors. A dynamic list of studies associated with this protocol will be included in the Study Procedures Manual. This protocol is designed in adherence with FDA and EMA guidelines.\n\nThe study involves up to 15 years post-infusion monitoring of subjects who have been exposed to lentivirus-mediated gene transfer in Adaptimmune clinical studies. Subjects will undergo clinical evaluation (i.e., new medical history, physical exam, adverse events, and exposure to mutagenic agents, anti-cancer therapies and investigational products in other clinical studies) with careful attention to adverse events possibly related to gene transfer or lentivirus-induced diseases. Blood samples will be collected for evaluating persistence of cells with lentiviral vector sequences, the detection of replication competent lentivirus (RCL), and chemistry and hematology laboratory assessments. Subjects will be followed for survival.","Long Term Follow Up Of Subjects Exposed To NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T, A Genetically Engineered NY-ESO-1 Specific T Cell Receptor","ADP-0000-002","Solid and Hematological Malignancies","Oncology Hematological Unspecified","Oncology Hematological","Oncology","NY-ESO-1&#x1D9C;&#xB2;&#x2075;&#x2079;T- treated",null,"Long term follow-up of subjects with solid or hematological malignancies who have received NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T in a previous trial","Genetic","NY-ESO-1&#x1D9C;&#xB2;&#x2075;&#x2079;T","No study drug is administered in this study. Patients who received NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T in a previous trial will be evaluated in this trial for long-term safety and efficacy.",null,null,"\n\n * Subjects must have received NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T cells in an Adaptimmune clinical study\n * Subjects who have provided informed consent prior to their study participation.\n\n","\n\n * None","NY-ESO-1",null,"Protein","Lung","Actual","2018-01-05","Actual","Anticipated","2047-05-01","Anticipated","2018-01-01","2018-01-02","2018-01-02","2018-01-02","No","Solid and Hematological Malignancies\nCell Therapy\nT Cell Therapy\nSPEAR T Cell\nImmuno-oncology\nNY-ESO-1\nMetastatic\nPreviously Treated\nT Cell Receptor\nSafety\nLong Term Follow Up\nGenetically engineered","Observational",{"$nulls":4},"18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":10},"Case-Only","Prospective","Samples With DNA","Whole blood, serum","Subjects with solid or hematological malignancies rolling over from interventional study where they were treated with genetically-modified T-cell receptor, NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T","Non-Probability Sample",1,null,null,"Number of subjects with specific Long Term Follow-Up adverse events (AEs), including serious adverse events (SAEs) associated with administration of Genetically Engineered NY-ESO-1 Specific T Cell Receptor","* New malignancies\n * New incidence or exacerbation of a pre-existing neurologic disorder\n * New incidence or exacerbation of a prior rheumatologic or other autoimmune disorder\n * New incidence of a hematologic disorder\n * Opportunistic and/or serious infections\n * Unanticipated illness and/or hospitalization deemed related to gene modified cell therapy","15 years post last treatment","Measurement of Replication Competent Lentivirus (RCL) in genetically modified T cells|Persistence of genetically modified cells in the body|Assess the pattern of vector integration sites if at least 1% of cells in the surrogate sample are positive for vector sequences by PCR|Overall Survival (OS) post-infusion","Subjects' peripheral blood samples will be used to evaluate RCL|Peripheral blood samples will be used to evaluate persistence|Number of samples positive for vector integration by PCR|OS defined as the interval between the date of first T cell infusion and date of death due to any cause","15 years post last treatment",{"$nulls":3},"Duarte, California, United States, 91010|Philadelphia, Pennsylvania, United States, 19104","California|Pennsylvania","United States","City Of Hope|University Of Pennsylvania Medicine",{"$nulls":4},"2018-01-02","2020-05-25T16:35:23.080","2020-05-26T17:10:42.972","NCT03391778"]
["5ecbf3cbe2561b1b11905cb1","NCT03391778","2018-04-26","Adaptimmune","ADAP","Enrolling by invitation","Long Term Follow up of Subjects Exposed to NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T","Ny-eso-1","Vaccine","Yes","['Ny-eso-1']","Yes","['Vaccine']",null,null,300,"Anticipated","2018-04-01","2047-05-01",{"$nulls":5},"Patients who were previously treated with Adaptimmune NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T cells are asked to take part in this study to see how safe NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T cells are and what side effects they might cause over 15 years. Patients will not be treated with NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T cells as part of this study.\n\nFor a period of 15 years starting from last treatment with NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T cells, patients will visit their study doctor to have their blood checked for any changes that might have happened because of the NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T cells. Patients can receive other therapies for their cancer while they are being followed for long term safety in this study.","This is a non-therapeutic, multi-center, long-term follow-up (LTFU) study of subjects who have, in a previous Adaptimmune clinical trial, received NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T by a process that utilizes lentiviral vectors. A dynamic list of studies associated with this protocol will be included in the Study Procedures Manual. This protocol is designed in adherence with FDA and EMA guidelines.\n\nThe study involves up to 15 years post-infusion monitoring of subjects who have been exposed to lentivirus-mediated gene transfer in Adaptimmune clinical studies. Subjects will undergo clinical evaluation (i.e., new medical history, physical exam, adverse events, and exposure to mutagenic agents, anti-cancer therapies and investigational products in other clinical studies) with careful attention to adverse events possibly related to gene transfer or lentivirus-induced diseases. Blood samples will be collected for evaluating persistence of cells with lentiviral vector sequences, the detection of replication competent lentivirus (RCL), and chemistry and hematology laboratory assessments. Subjects will be followed for survival.","Long Term Follow Up Of Subjects Exposed To NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T, A Genetically Engineered NY-ESO-1 Specific T Cell Receptor","ADP-0000-002","Solid and Hematological Malignancies","Oncology Hematological Unspecified","Oncology Hematological","Oncology","NY-ESO-1&#x1D9C;&#xB2;&#x2075;&#x2079;T- treated",null,"Long term follow-up of subjects with solid or hematological malignancies who have received NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T in a previous trial","Genetic","NY-ESO-1&#x1D9C;&#xB2;&#x2075;&#x2079;T","No study drug is administered in this study. Patients who received NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T in a previous trial will be evaluated in this trial for long-term safety and efficacy.",null,null,"\n\n * Subjects must have received NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T cells in an Adaptimmune clinical study\n * Subjects who have provided informed consent prior to their study participation.\n\n","\n\n * None","NY-ESO-1",null,"Protein","Lung","Actual","2018-01-05","Actual","Anticipated","2047-05-01","Anticipated","2018-04-01","2018-01-02","2018-01-02","2018-04-25","No","Solid and Hematological Malignancies\nCell Therapy\nT Cell Therapy\nSPEAR T Cell\nImmuno-oncology\nNY-ESO-1\nMetastatic\nPreviously Treated\nT Cell Receptor\nSafety\nLong Term Follow Up\nGenetically engineered","Observational",{"$nulls":4},"18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":10},"Case-Only","Prospective","Samples With DNA","Whole blood, serum","Subjects with solid or hematological malignancies rolling over from interventional study where they were treated with genetically-modified T-cell receptor, NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T","Non-Probability Sample",1,null,null,"Number of subjects with specific Long Term Follow-Up adverse events (AEs), including serious adverse events (SAEs) associated with administration of Genetically Engineered NY-ESO-1 Specific T Cell Receptor","* New malignancies\n * New incidence or exacerbation of a pre-existing neurologic disorder\n * New incidence or exacerbation of a prior rheumatologic or other autoimmune disorder\n * New incidence of a hematologic disorder\n * Opportunistic and/or serious infections\n * Unanticipated illness and/or hospitalization deemed related to gene modified cell therapy","15 years post last treatment","Measurement of Replication Competent Lentivirus (RCL) in genetically modified T cells|Persistence of genetically modified cells in the body|Assess the pattern of vector integration sites if at least 1% of cells in the surrogate sample are positive for vector sequences by PCR|Overall Survival (OS) post-infusion","Subjects' peripheral blood samples will be used to evaluate RCL|Peripheral blood samples will be used to evaluate persistence|Number of samples positive for vector integration by PCR|OS defined as the interval between the date of first T cell infusion and date of death due to any cause","15 years post last treatment",{"$nulls":3},"Duarte, California, United States, 91010|Philadelphia, Pennsylvania, United States, 19104","California|Pennsylvania","United States","City Of Hope|University Of Pennsylvania Medicine",{"$nulls":4},"2018-04-25","2020-05-25T16:35:23.382","2020-05-26T17:10:42.972","NCT03391778"]
["5ecbf3cbe2561b1b11905cb0","NCT03391778","2018-05-07","Adaptimmune","ADAP","Enrolling by invitation","Long Term Follow up of Subjects Exposed to NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T","Ny-eso-1","Vaccine","Yes","['Ny-eso-1']","Yes","['Vaccine']",null,null,300,"Anticipated","2018-04-09","2047-05-01",{"$nulls":5},"Patients who were previously treated with Adaptimmune NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T cells are asked to take part in this study to see how safe NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T cells are and what side effects they might cause over 15 years. Patients will not be treated with NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T cells as part of this study.\n\nFor a period of 15 years starting from last treatment with NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T cells, patients will visit their study doctor to have their blood checked for any changes that might have happened because of the NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T cells. Patients can receive other therapies for their cancer while they are being followed for long term safety in this study.","This is a non-therapeutic, multi-center, long-term follow-up (LTFU) study of subjects who have, in a previous Adaptimmune clinical trial, received NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T by a process that utilizes lentiviral vectors. A dynamic list of studies associated with this protocol will be included in the Study Procedures Manual. This protocol is designed in adherence with FDA and EMA guidelines.\n\nThe study involves up to 15 years post-infusion monitoring of subjects who have been exposed to lentivirus-mediated gene transfer in Adaptimmune clinical studies. Subjects will undergo clinical evaluation (i.e., new medical history, physical exam, adverse events, and exposure to mutagenic agents, anti-cancer therapies and investigational products in other clinical studies) with careful attention to adverse events possibly related to gene transfer or lentivirus-induced diseases. Blood samples will be collected for evaluating persistence of cells with lentiviral vector sequences, the detection of replication competent lentivirus (RCL), and chemistry and hematology laboratory assessments. Subjects will be followed for survival.","Long Term Follow Up Of Subjects Exposed To NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T, A Genetically Engineered NY-ESO-1 Specific T Cell Receptor","ADP-0000-002","Solid and Hematological Malignancies","Oncology Hematological Unspecified","Oncology Hematological","Oncology","NY-ESO-1&#x1D9C;&#xB2;&#x2075;&#x2079;T- treated",null,"Long term follow-up of subjects with solid or hematological malignancies who have received NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T in a previous trial","Genetic","NY-ESO-1&#x1D9C;&#xB2;&#x2075;&#x2079;T","No study drug is administered in this study. Patients who received NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T in a previous trial will be evaluated in this trial for long-term safety and efficacy.",null,null,"\n\n * Subjects must have received NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T cells in an Adaptimmune clinical study\n * Subjects who have provided informed consent prior to their study participation.\n\n","\n\n * None","NY-ESO-1",null,"Protein","Lung","Actual","2018-01-05","Actual","Anticipated","2047-05-01","Anticipated","2018-05-01","2018-01-02","2018-01-02","2018-05-04","No","Solid and Hematological Malignancies\nCell Therapy\nT Cell Therapy\nSPEAR T Cell\nImmuno-oncology\nNY-ESO-1\nMetastatic\nPreviously Treated\nT Cell Receptor\nSafety\nLong Term Follow Up\nGenetically engineered","Observational",{"$nulls":4},"18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":10},"Case-Only","Prospective","Samples With DNA","Whole blood, serum","Subjects with solid or hematological malignancies rolling over from interventional study where they were treated with genetically-modified T-cell receptor, NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T","Non-Probability Sample",1,null,null,"Number of subjects with specific Long Term Follow-Up adverse events (AEs), including serious adverse events (SAEs) associated with administration of Genetically Engineered NY-ESO-1 Specific T Cell Receptor","* New malignancies\n * New incidence or exacerbation of a pre-existing neurologic disorder\n * New incidence or exacerbation of a prior rheumatologic or other autoimmune disorder\n * New incidence of a hematologic disorder\n * Opportunistic and/or serious infections\n * Unanticipated illness and/or hospitalization deemed related to gene modified cell therapy","15 years post last treatment","Measurement of Replication Competent Lentivirus (RCL) in genetically modified T cells|Persistence of genetically modified cells in the body|Assess the pattern of vector integration sites if at least 1% of cells in the surrogate sample are positive for vector sequences by PCR|Overall Survival (OS) post-infusion","Subjects' peripheral blood samples will be used to evaluate RCL|Peripheral blood samples will be used to evaluate persistence|Number of samples positive for vector integration by PCR|OS defined as the interval between the date of first T cell infusion and date of death due to any cause","15 years post last treatment",{"$nulls":3},"Duarte, California, United States, 91010|New York, New York, United States, 10065|Philadelphia, Pennsylvania, United States, 19104","California|New York|Pennsylvania","United States","City Of Hope|Memorial Sloan Kettering Cancer Center|University Of Pennsylvania Medicine",{"$nulls":4},"2018-05-04","2020-05-25T16:35:23.144","2020-05-26T17:10:42.972","NCT03391778"]
["5ecbf3cbfe30261b1a0481b5","NCT03391778","2018-05-15","Adaptimmune","ADAP","Enrolling by invitation","Long Term Follow up of Subjects Exposed to NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T","Ny-eso-1","Vaccine","Yes","['Ny-eso-1']","Yes","['Vaccine']",null,null,300,"Anticipated","2018-04-09","2047-05-01",{"$nulls":5},"Patients who were previously treated with Adaptimmune NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T cells are asked to take part in this study to see how safe NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T cells are and what side effects they might cause over 15 years. Patients will not be treated with NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T cells as part of this study.\n\nFor a period of 15 years starting from last treatment with NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T cells, patients will visit their study doctor to have their blood checked for any changes that might have happened because of the NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T cells. Patients can receive other therapies for their cancer while they are being followed for long term safety in this study.","This is a non-therapeutic, multi-center, long-term follow-up (LTFU) study of subjects who have, in a previous Adaptimmune clinical trial, received NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T by a process that utilizes lentiviral vectors. A dynamic list of studies associated with this protocol will be included in the Study Procedures Manual. This protocol is designed in adherence with FDA and EMA guidelines.\n\nThe study involves up to 15 years post-infusion monitoring of subjects who have been exposed to lentivirus-mediated gene transfer in Adaptimmune clinical studies. Subjects will undergo clinical evaluation (i.e., new medical history, physical exam, adverse events, and exposure to mutagenic agents, anti-cancer therapies and investigational products in other clinical studies) with careful attention to adverse events possibly related to gene transfer or lentivirus-induced diseases. Blood samples will be collected for evaluating persistence of cells with lentiviral vector sequences, the detection of replication competent lentivirus (RCL), and chemistry and hematology laboratory assessments. Subjects will be followed for survival.","Long Term Follow Up Of Subjects Exposed To NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T, A Genetically Engineered NY-ESO-1 Specific T Cell Receptor","ADP-0000-002","Solid and Hematological Malignancies","Oncology Hematological Unspecified","Oncology Hematological","Oncology","NY-ESO-1&#x1D9C;&#xB2;&#x2075;&#x2079;T- treated",null,"Long term follow-up of subjects with solid or hematological malignancies who have received NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T in a previous trial","Genetic","NY-ESO-1&#x1D9C;&#xB2;&#x2075;&#x2079;T","No study drug is administered in this study. Patients who received NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T in a previous trial will be evaluated in this trial for long-term safety and efficacy.",null,null,"\n\n * Subjects must have received NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T cells in an Adaptimmune clinical study\n * Subjects who have provided informed consent prior to their study participation.\n\n","\n\n * None","NY-ESO-1",null,"Protein","Lung","Actual","2018-01-05","Actual","Anticipated","2047-05-01","Anticipated","2018-05-01","2018-01-02","2018-01-02","2018-05-14","No","Solid and Hematological Malignancies\nCell Therapy\nT Cell Therapy\nSPEAR T Cell\nImmuno-oncology\nNY-ESO-1\nMetastatic\nPreviously Treated\nT Cell Receptor\nSafety\nLong Term Follow Up\nGenetically engineered","Observational",{"$nulls":4},"18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":10},"Case-Only","Prospective","Samples With DNA","Whole blood, serum","Subjects with solid or hematological malignancies rolling over from interventional study where they were treated with genetically-modified T-cell receptor, NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T","Non-Probability Sample",1,null,null,"Number of subjects with specific Long Term Follow-Up adverse events (AEs), including serious adverse events (SAEs) associated with administration of Genetically Engineered NY-ESO-1 Specific T Cell Receptor","* New malignancies\n * New incidence or exacerbation of a pre-existing neurologic disorder\n * New incidence or exacerbation of a prior rheumatologic or other autoimmune disorder\n * New incidence of a hematologic disorder\n * Opportunistic and/or serious infections\n * Unanticipated illness and/or hospitalization deemed related to gene modified cell therapy","15 years post last treatment","Measurement of Replication Competent Lentivirus (RCL) in genetically modified T cells|Persistence of genetically modified cells in the body|Assess the pattern of vector integration sites if at least 1% of cells in the surrogate sample are positive for vector sequences by PCR|Overall Survival (OS) post-infusion","Subjects' peripheral blood samples will be used to evaluate RCL|Peripheral blood samples will be used to evaluate persistence|Number of samples positive for vector integration by PCR|OS defined as the interval between the date of first T cell infusion and date of death due to any cause","15 years post last treatment",{"$nulls":3},"Duarte, California, United States, 91010|Bethesda, Maryland, United States, 20892|New York, New York, United States, 10065|Philadelphia, Pennsylvania, United States, 19104","California|Maryland|New York|Pennsylvania","United States","City Of Hope|National Institutes Of Health|Memorial Sloan Kettering Cancer Center|University Of Pennsylvania Medicine",{"$nulls":4},"2018-05-14","2020-05-25T16:35:23.249","2020-05-26T17:10:42.972","NCT03391778"]
["5ecbf3cb307e3d1b1f8d9c45","NCT03391778","2018-05-16","Adaptimmune","ADAP","Enrolling by invitation","Long Term Follow up of Subjects Exposed to NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T","Ny-eso-1","Vaccine","Yes","['Ny-eso-1']","Yes","['Vaccine']",null,null,300,"Anticipated","2018-04-09","2047-05-01",{"$nulls":5},"Patients who were previously treated with Adaptimmune NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T cells are asked to take part in this study to see how safe NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T cells are and what side effects they might cause over 15 years. Patients will not be treated with NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T cells as part of this study.\n\nFor a period of 15 years starting from last treatment with NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T cells, patients will visit their study doctor to have their blood checked for any changes that might have happened because of the NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T cells. Patients can receive other therapies for their cancer while they are being followed for long term safety in this study.","This is a non-therapeutic, multi-center, long-term follow-up (LTFU) study of subjects who have, in a previous Adaptimmune clinical trial, received NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T by a process that utilizes lentiviral vectors. A dynamic list of studies associated with this protocol will be included in the Study Procedures Manual. This protocol is designed in adherence with FDA and EMA guidelines.\n\nThe study involves up to 15 years post-infusion monitoring of subjects who have been exposed to lentivirus-mediated gene transfer in Adaptimmune clinical studies. Subjects will undergo clinical evaluation (i.e., new medical history, physical exam, adverse events, and exposure to mutagenic agents, anti-cancer therapies and investigational products in other clinical studies) with careful attention to adverse events possibly related to gene transfer or lentivirus-induced diseases. Blood samples will be collected for evaluating persistence of cells with lentiviral vector sequences, the detection of replication competent lentivirus (RCL), and chemistry and hematology laboratory assessments. Subjects will be followed for survival.","Long Term Follow Up Of Subjects Exposed To NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T, A Genetically Engineered NY-ESO-1 Specific T Cell Receptor","ADP-0000-002","Solid and Hematological Malignancies","Oncology Hematological Unspecified","Oncology Hematological","Oncology","NY-ESO-1&#x1D9C;&#xB2;&#x2075;&#x2079;T- treated",null,"Long term follow-up of subjects with solid or hematological malignancies who have received NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T in a previous trial","Genetic","NY-ESO-1&#x1D9C;&#xB2;&#x2075;&#x2079;T","No study drug is administered in this study. Patients who received NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T in a previous trial will be evaluated in this trial for long-term safety and efficacy.",null,null,"\n\n * Subjects must have received NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T cells in an Adaptimmune clinical study\n * Subjects who have provided informed consent prior to their study participation.\n\n","\n\n * None","NY-ESO-1",null,"Protein","Lung","Actual","2018-01-05","Actual","Anticipated","2047-05-01","Anticipated","2018-05-01","2018-01-02","2018-01-02","2018-05-15","No","Solid and Hematological Malignancies\nCell Therapy\nT Cell Therapy\nSPEAR T Cell\nImmuno-oncology\nNY-ESO-1\nMetastatic\nPreviously Treated\nT Cell Receptor\nSafety\nLong Term Follow Up\nGenetically engineered","Observational",{"$nulls":4},"18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":10},"Case-Only","Prospective","Samples With DNA","Whole blood, serum","Subjects with solid or hematological malignancies rolling over from interventional study where they were treated with genetically-modified T-cell receptor, NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T","Non-Probability Sample",1,null,null,"Number of subjects with specific Long Term Follow-Up adverse events (AEs), including serious adverse events (SAEs) associated with administration of Genetically Engineered NY-ESO-1 Specific T Cell Receptor","* New malignancies\n * New incidence or exacerbation of a pre-existing neurologic disorder\n * New incidence or exacerbation of a prior rheumatologic or other autoimmune disorder\n * New incidence of a hematologic disorder\n * Opportunistic and/or serious infections\n * Unanticipated illness and/or hospitalization deemed related to gene modified cell therapy","15 years post last treatment","Measurement of Replication Competent Lentivirus (RCL) in genetically modified T cells|Persistence of genetically modified cells in the body|Assess the pattern of vector integration sites if at least 1% of cells in the surrogate sample are positive for vector sequences by PCR|Overall Survival (OS) post-infusion","Subjects' peripheral blood samples will be used to evaluate RCL|Peripheral blood samples will be used to evaluate persistence|Number of samples positive for vector integration by PCR|OS defined as the interval between the date of first T cell infusion and date of death due to any cause","15 years post last treatment",{"$nulls":3},"Duarte, California, United States, 91010|Tampa, Florida, United States, 33612|Bethesda, Maryland, United States, 20892|New York, New York, United States, 10065|Philadelphia, Pennsylvania, United States, 19104","California|Florida|Maryland|New York|Pennsylvania","United States","City Of Hope|Moffitt Cancer Center|National Institutes Of Health|Memorial Sloan Kettering Cancer Center|University Of Pennsylvania Medicine",{"$nulls":4},"2018-05-15","2020-05-25T16:35:23.303","2020-05-26T17:10:42.972","NCT03391778"]
["5ecbf3cbfeab101b155307e5","NCT03391778","2018-05-25","Adaptimmune","ADAP","Enrolling by invitation","Long Term Follow up of Subjects Exposed to NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T","Ny-eso-1","Vaccine","Yes","['Ny-eso-1']","Yes","['Vaccine']",null,null,300,"Anticipated","2018-04-09","2047-05-01",{"$nulls":5},"Patients who were previously treated with Adaptimmune NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T cells are asked to take part in this study to see how safe NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T cells are and what side effects they might cause over 15 years. Patients will not be treated with NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T cells as part of this study.\n\nFor a period of 15 years starting from last treatment with NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T cells, patients will visit their study doctor to have their blood checked for any changes that might have happened because of the NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T cells. Patients can receive other therapies for their cancer while they are being followed for long term safety in this study.","This is a non-therapeutic, multi-center, long-term follow-up (LTFU) study of subjects who have, in a previous Adaptimmune clinical trial, received NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T by a process that utilizes lentiviral vectors. A dynamic list of studies associated with this protocol will be included in the Study Procedures Manual. This protocol is designed in adherence with FDA and EMA guidelines.\n\nThe study involves up to 15 years post-infusion monitoring of subjects who have been exposed to lentivirus-mediated gene transfer in Adaptimmune clinical studies. Subjects will undergo clinical evaluation (i.e., new medical history, physical exam, adverse events, and exposure to mutagenic agents, anti-cancer therapies and investigational products in other clinical studies) with careful attention to adverse events possibly related to gene transfer or lentivirus-induced diseases. Blood samples will be collected for evaluating persistence of cells with lentiviral vector sequences, the detection of replication competent lentivirus (RCL), and chemistry and hematology laboratory assessments. Subjects will be followed for survival.","Long Term Follow Up Of Subjects Exposed To NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T, A Genetically Engineered NY-ESO-1 Specific T Cell Receptor","ADP-0000-002","Solid and Hematological Malignancies","Oncology Hematological Unspecified","Oncology Hematological","Oncology","NY-ESO-1&#x1D9C;&#xB2;&#x2075;&#x2079;T- treated",null,"Long term follow-up of subjects with solid or hematological malignancies who have received NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T in a previous trial","Genetic","NY-ESO-1&#x1D9C;&#xB2;&#x2075;&#x2079;T","No study drug is administered in this study. Patients who received NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T in a previous trial will be evaluated in this trial for long-term safety and efficacy.",null,null,"\n\n * Subjects must have received NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T cells in an Adaptimmune clinical study\n * Subjects who have provided informed consent prior to their study participation.\n\n","\n\n * None","NY-ESO-1",null,"Protein","Lung","Actual","2018-01-05","Actual","Anticipated","2047-05-01","Anticipated","2018-05-01","2018-01-02","2018-01-02","2018-05-24","No","Solid and Hematological Malignancies\nCell Therapy\nT Cell Therapy\nSPEAR T Cell\nImmuno-oncology\nNY-ESO-1\nMetastatic\nPreviously Treated\nT Cell Receptor\nSafety\nLong Term Follow Up\nGenetically engineered","Observational",{"$nulls":4},"18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":10},"Case-Only","Prospective","Samples With DNA","Whole blood, serum","Subjects with solid or hematological malignancies rolling over from interventional study where they were treated with genetically-modified T-cell receptor, NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T","Non-Probability Sample",1,null,null,"Number of subjects with specific Long Term Follow-Up adverse events (AEs), including serious adverse events (SAEs) associated with administration of Genetically Engineered NY-ESO-1 Specific T Cell Receptor","* New malignancies\n * New incidence or exacerbation of a pre-existing neurologic disorder\n * New incidence or exacerbation of a prior rheumatologic or other autoimmune disorder\n * New incidence of a hematologic disorder\n * Opportunistic and/or serious infections\n * Unanticipated illness and/or hospitalization deemed related to gene modified cell therapy","15 years post last treatment","Measurement of Replication Competent Lentivirus (RCL) in genetically modified T cells|Persistence of genetically modified cells in the body|Assess the pattern of vector integration sites if at least 1% of cells in the surrogate sample are positive for vector sequences by PCR|Overall Survival (OS) post-infusion","Subjects' peripheral blood samples will be used to evaluate RCL|Peripheral blood samples will be used to evaluate persistence|Number of samples positive for vector integration by PCR|OS defined as the interval between the date of first T cell infusion and date of death due to any cause","15 years post last treatment",{"$nulls":3},"Duarte, California, United States, 91010|Tampa, Florida, United States, 33612|Bethesda, Maryland, United States, 20892|Saint Louis, Missouri, United States, 63110|New York, New York, United States, 10065|Philadelphia, Pennsylvania, United States, 19104","California|Florida|Maryland|Missouri|New York|Pennsylvania","United States","City Of Hope|Moffitt Cancer Center|National Institutes Of Health|Washington University In St. Louis|Memorial Sloan Kettering Cancer Center|University Of Pennsylvania Medicine",{"$nulls":4},"2018-05-24","2020-05-25T16:35:23.367","2020-05-26T17:10:42.972","NCT03391778"]
["5ecbf3cbfeab101b155307e6","NCT03391778","2018-06-06","Adaptimmune","ADAP","Enrolling by invitation","Long Term Follow up of Subjects Exposed to NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T","Ny-eso-1","Vaccine","Yes","['Ny-eso-1']","Yes","['Vaccine']",null,null,300,"Anticipated","2018-04-09","2047-05-01",{"$nulls":5},"Patients who were previously treated with Adaptimmune NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T cells are asked to take part in this study to see how safe NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T cells are and what side effects they might cause over 15 years. Patients will not be treated with NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T cells as part of this study.\n\nFor a period of 15 years starting from last treatment with NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T cells, patients will visit their study doctor to have their blood checked for any changes that might have happened because of the NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T cells. Patients can receive other therapies for their cancer while they are being followed for long term safety in this study.","This is a non-therapeutic, multi-center, long-term follow-up (LTFU) study of subjects who have, in a previous Adaptimmune clinical trial, received NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T by a process that utilizes lentiviral vectors. A dynamic list of studies associated with this protocol will be included in the Study Procedures Manual. This protocol is designed in adherence with FDA and EMA guidelines.\n\nThe study involves up to 15 years post-infusion monitoring of subjects who have been exposed to lentivirus-mediated gene transfer in Adaptimmune clinical studies. Subjects will undergo clinical evaluation (i.e., new medical history, physical exam, adverse events, and exposure to mutagenic agents, anti-cancer therapies and investigational products in other clinical studies) with careful attention to adverse events possibly related to gene transfer or lentivirus-induced diseases. Blood samples will be collected for evaluating persistence of cells with lentiviral vector sequences, the detection of replication competent lentivirus (RCL), and chemistry and hematology laboratory assessments. Subjects will be followed for survival.","Long Term Follow Up Of Subjects Exposed To NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T, A Genetically Engineered NY-ESO-1 Specific T Cell Receptor","ADP-0000-002","Solid and Hematological Malignancies","Oncology Hematological Unspecified","Oncology Hematological","Oncology","NY-ESO-1&#x1D9C;&#xB2;&#x2075;&#x2079;T- treated",null,"Long term follow-up of subjects with solid or hematological malignancies who have received NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T in a previous trial","Genetic","NY-ESO-1&#x1D9C;&#xB2;&#x2075;&#x2079;T","No study drug is administered in this study. Patients who received NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T in a previous trial will be evaluated in this trial for long-term safety and efficacy.",null,null,"\n\n * Subjects must have received NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T cells in an Adaptimmune clinical study\n * Subjects who have provided informed consent prior to their study participation.\n\n","\n\n * None","NY-ESO-1",null,"Protein","Lung","Actual","2018-01-05","Actual","Anticipated","2047-05-01","Anticipated","2018-06-01","2018-01-02","2018-01-02","2018-06-04","No","Solid and Hematological Malignancies\nCell Therapy\nT Cell Therapy\nSPEAR T Cell\nImmuno-oncology\nNY-ESO-1\nMetastatic\nPreviously Treated\nT Cell Receptor\nSafety\nLong Term Follow Up\nGenetically engineered","Observational",{"$nulls":4},"18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":10},"Case-Only","Prospective","Samples With DNA","Whole blood, serum","Subjects with solid or hematological malignancies rolling over from interventional study where they were treated with genetically-modified T-cell receptor, NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T","Non-Probability Sample",1,null,null,"Number of subjects with specific Long Term Follow-Up adverse events (AEs), including serious adverse events (SAEs) associated with administration of Genetically Engineered NY-ESO-1 Specific T Cell Receptor","* New malignancies\n * New incidence or exacerbation of a pre-existing neurologic disorder\n * New incidence or exacerbation of a prior rheumatologic or other autoimmune disorder\n * New incidence of a hematologic disorder\n * Opportunistic and/or serious infections\n * Unanticipated illness and/or hospitalization deemed related to gene modified cell therapy","15 years post last treatment","Measurement of Replication Competent Lentivirus (RCL) in genetically modified T cells|Persistence of genetically modified cells in the body|Assess the pattern of vector integration sites if at least 1% of cells in the surrogate sample are positive for vector sequences by PCR|Overall Survival (OS) post-infusion","Subjects' peripheral blood samples will be used to evaluate RCL|Peripheral blood samples will be used to evaluate persistence|Number of samples positive for vector integration by PCR|OS defined as the interval between the date of first T cell infusion and date of death due to any cause","15 years post last treatment",{"$nulls":3},"Duarte, California, United States, 91010|Tampa, Florida, United States, 33612|Bethesda, Maryland, United States, 20892|Boston, Massachusetts, United States, 02215|Saint Louis, Missouri, United States, 63110|New York, New York, United States, 10065|Philadelphia, Pennsylvania, United States, 19104","California|Florida|Maryland|Massachusetts|Missouri|New York|Pennsylvania","United States","City Of Hope|Moffitt Cancer Center|National Institutes Of Health|Dana Farber Cancer Institute (Dfci)|Washington University In St. Louis|Memorial Sloan Kettering Cancer Center|University Of Pennsylvania Medicine",{"$nulls":4},"2018-06-04","2020-05-25T16:35:23.891","2020-05-26T17:10:42.972","NCT03391778"]
["5ecbf3cb11702c1b1b9169c9","NCT03391778","2018-10-16","GlaxoSmithKline","GSK","Recruiting","Long Term Follow-Up of Subjects Exposed to GSK3377794","Ny-eso-1","Vaccine","Yes","['Ny-eso-1']","Yes","['Vaccine']","Phase 1",1,200,"Anticipated","2018-04-09","2032-04-01",{"$nulls":5},"This is a non-therapeutic, multi-center, long-term follow-up (LTFU) study of subjects who have, during the interventional study, received GSK3377794 generated by a process that utilizes lentiviral vectors. Subjects enrolled in the interventional studies who complete the interventional study or who withdraw from the interventional study will enter this LTFU study and will be followed for up to 15 years from the infusion of genetically modified T lymphocytes. Subjects can receive other therapies for their cancer while they are being followed for long term safety in this study.","This is a non-therapeutic, multi-center, LTFU study of subjects who have, in a previous GlaxoSmithKline (GSK) clinical trial, received GSK3377794 (NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T) by a process that utilizes lentiviral vectors. This protocol is designed in adherence with Food and Drug Administration (FDA) and European Medicines Agency (EMA) guidelines. The study involves up to 15 years post-infusion monitoring of subjects who have been exposed to lentivirus-mediated gene transfer in GSK clinical studies. Subjects will undergo clinical evaluation (i.e., new medical history, physical exam, adverse events, and exposure to mutagenic agents, anti-cancer therapies and investigational products in other clinical studies) with careful attention to adverse events possibly related to gene transfer or lentivirus-induced diseases. Blood samples will be collected for evaluating persistence of cells with lentiviral vector sequences, the detection of replication competent lentivirus (RCL), and chemistry and hematology laboratory assessments. Subjects will be followed for survival.","Long Term Follow-Up of Participants Exposed to GSK3377794 (NY-ESO-1c259 T), a Genetically Engineered NY-ESO-1 Specific T Cell Receptor",208750,"Neoplasms","Oncology Hematological Unspecified|Ear Cancer","Oncology Hematological|Oncology Solid Tumor","Oncology","Experimental","GSK3377794","Long term follow-up of subjects with solid or hematological malignancies who have received NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T in a previous trial","Genetic","GSK3377794 (NY-ESO-1&#x1D9C;&#xB2;&#x2075;&#x2079; T)","No study drug is administered in this study. Subjects who received NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T in a previous trial will be evaluated in this trial for long-term safety and efficacy.",null,"GSK3377794","\n\n * Subjects who have received at least one dose of GSK3377794 in the interventional study.\n * Subjects who have either completed the interventional study or have withdrawn from it.\n * Male or Female subjects.\n * Capable of giving signed informed consent prior to the study participation.\n\n","\n\n * None","NY-ESO-1",null,"Protein","Lung","Actual","2018-01-05","Actual","Anticipated","2032-04-01","Anticipated","2018-10-01","2018-01-02","2018-01-02","2018-10-12","No","Genetically engineered\nImmuno-oncology\nT Cell Therapy\nT Cell Receptor\nPreviously Treated\nCell Therapy\nSPEAR T Cell\nMetastatic\nSolid and Hematological Malignancies\nSafety\nLong Term Follow Up\nNY-ESO-1","Interventional","Other","Single Group Assignment","None (Open Label)","N/A","4 Years",null,"All",null,"No","Yes\nIPD for this study will be made available via the Clinical Study Data Request site.",{"$nulls":3},"Yes","No",{"$nulls":17},"ADP-0000-002","Adaptimmune Therapeutics","Number of subjects with delayed adverse events (AEs) associated with administration of autologous cells that have been genetically modified by lentiviral vectors","The following AEs will be reported:\n\n * New malignancies\n * New incidence or exacerbation of a pre-existing neurologic disorder\n * New incidence or exacerbation of a prior rheumatologic or other autoimmune disorder\n * New incidence of immune-related hematologic disorder\n * Serious infections (including opportunistic)\n * Unanticipated illness and/or hospitalization deemed related to gene modified cell therapy","15 years post last treatment","Number of subjects with Vesicular Stomatitis Virus G protein (VSV-G) DNA copies|Number of subjects with Woodchuck hepatitis virus posttranscriptional regulatory element (WPRE) or Psi DNA copies|Number of subjects with integrated vector sequences and vector integration patterns|Number of deaths|Time to death","Peripheral blood samples will be collected and tested for the presence of VSV-G DNA copies.|The persistence of genetically modified cells will be measured by detecting the presence of WPRE or Psi DNA in the peripheral blood samples.|Integrated vector sequences and vector integration patterns (e.g., polyclonal, oligoclonal, or monoclonal) will be identified in the peripheral blood samples.|Number of deaths will be summarized.|Time to death will be summarized.","15 years","GSKClinicalSupportHD@gsk.com","US GSK Clinical Trials Call Center","877-379-3718","Duarte, California, United States, 91010|Tampa, Florida, United States, 33612|Bethesda, Maryland, United States, 20892|Boston, Massachusetts, United States, 02215|Saint Louis, Missouri, United States, 63110|New York, New York, United States, 10065|Philadelphia, Pennsylvania, United States, 19104","California|Florida|Maryland|Massachusetts|Missouri|New York|Pennsylvania","United States","Gsk Investigational Site",{"$nulls":3},"GSK Clinical Trials","2018-10-12","2020-05-25T16:35:23.497","2020-05-26T17:10:42.972","NCT03391778"]
["5ecbf3cc11702c1b1b9169ca","NCT03391778","2019-06-21","GlaxoSmithKline","GSK","Recruiting","Long Term Follow-Up of Subjects Exposed to GSK3377794","Ny-eso-1","Vaccine","Yes","['Ny-eso-1']","Yes","['Vaccine']","Phase 1",1,200,"Anticipated","2018-04-09","2032-04-01",{"$nulls":5},"This is a non-therapeutic, multi-center, long-term follow-up (LTFU) study of subjects who have, during the interventional study, received GSK3377794 generated by a process that utilizes lentiviral vectors. Subjects enrolled in the interventional studies who complete the interventional study or who withdraw from the interventional study will enter this LTFU study and will be followed for up to 15 years from the infusion of genetically modified T lymphocytes. Subjects can receive other therapies for their cancer while they are being followed for long term safety in this study.","This is a non-therapeutic, multi-center, LTFU study of subjects who have, in a previous GlaxoSmithKline (GSK) clinical trial, received GSK3377794 (NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T) by a process that utilizes lentiviral vectors. This protocol is designed in adherence with Food and Drug Administration (FDA) and European Medicines Agency (EMA) guidelines. The study involves up to 15 years post-infusion monitoring of subjects who have been exposed to lentivirus-mediated gene transfer in GSK clinical studies. Subjects will undergo clinical evaluation (i.e., new medical history, physical exam, adverse events, and exposure to mutagenic agents, anti-cancer therapies and investigational products in other clinical studies) with careful attention to adverse events possibly related to gene transfer or lentivirus-induced diseases. Blood samples will be collected for evaluating persistence of cells with lentiviral vector sequences, the detection of replication competent lentivirus (RCL), and chemistry and hematology laboratory assessments. Subjects will be followed for survival.","Long Term Follow-Up of Participants Exposed to GSK3377794 (NY-ESO-1c259 T), a Genetically Engineered NY-ESO-1 Specific T Cell Receptor",208750,"Neoplasms","Oncology Hematological Unspecified|Ear Cancer","Oncology Hematological|Oncology Solid Tumor","Oncology","Experimental","GSK3377794","Long term follow-up of subjects with solid or hematological malignancies who have received NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T in a previous trial","Genetic","GSK3377794 (NY-ESO-1&#x1D9C;&#xB2;&#x2075;&#x2079; T)","No study drug is administered in this study. Subjects who received NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T in a previous trial will be evaluated in this trial for long-term safety and efficacy.",null,"GSK3377794","\n\n * Subjects who have received at least one dose of GSK3377794 in the interventional study.\n * Subjects who have either completed the interventional study or have withdrawn from it.\n * Male or Female subjects.\n * Capable of giving signed informed consent prior to the study participation.\n\n","\n\n * None","NY-ESO-1",null,"Protein","Lung","Actual","2018-01-05","Actual","Anticipated","2032-04-01","Anticipated","2019-06-01","2018-01-02","2018-01-02","2019-06-19","No","Genetically engineered\nImmuno-oncology\nT Cell Therapy\nT Cell Receptor\nPreviously Treated\nCell Therapy\nSPEAR T Cell\nMetastatic\nSolid and Hematological Malignancies\nSafety\nLong Term Follow Up\nNY-ESO-1","Interventional","Other","Single Group Assignment","None (Open Label)","N/A","4 Years",null,"All",null,"No","Yes\nIPD for this study will be made available via the Clinical Study Data Request site.",{"$nulls":3},"Yes","No",{"$nulls":17},"ADP-0000-002","Adaptimmune Therapeutics","Number of subjects with delayed adverse events (AEs) associated with administration of autologous cells that have been genetically modified by lentiviral vectors","The following AEs will be reported:\n\n * New malignancies\n * New incidence or exacerbation of a pre-existing neurologic disorder\n * New incidence or exacerbation of a prior rheumatologic or other autoimmune disorder\n * New incidence of immune-related hematologic disorder\n * Serious infections (including opportunistic)\n * Unanticipated illness and/or hospitalization deemed related to gene modified cell therapy","15 years post last treatment","Number of subjects with Vesicular Stomatitis Virus G protein (VSV-G) DNA copies|Number of subjects with Woodchuck hepatitis virus posttranscriptional regulatory element (WPRE) or Psi DNA copies|Number of subjects with integrated vector sequences and vector integration patterns|Number of deaths|Time to death","Peripheral blood samples will be collected and tested for the presence of VSV-G DNA copies.|The persistence of genetically modified cells will be measured by detecting the presence of WPRE or Psi DNA in the peripheral blood samples.|Integrated vector sequences and vector integration patterns (e.g., polyclonal, oligoclonal, or monoclonal) will be identified in the peripheral blood samples.|Number of deaths will be summarized.|Time to death will be summarized.","15 years","GSKClinicalSupportHD@gsk.com","US GSK Clinical Trials Call Center","877-379-3718","Tampa, Florida, United States, 33612|Bethesda, Maryland, United States, 20892|Boston, Massachusetts, United States, 02215|Saint Louis, Missouri, United States, 63110|New York, New York, United States, 10065|Philadelphia, Pennsylvania, United States, 19104","Florida|Maryland|Massachusetts|Missouri|New York|Pennsylvania","United States","Gsk Investigational Site","GSKClinicalSupportHD@gsk.com","EU GSK Clinical Trials Call Center","+44 (0) 20 89904466","GSK Clinical Trials","2019-06-19","2020-05-25T16:35:24.008","2020-05-26T17:10:42.972","NCT03391778"]
["5ecbf3cb307e3d1b1f8d9c46","NCT03391778","2019-07-18","GlaxoSmithKline","GSK","Recruiting","Long Term Follow-Up of Subjects Exposed to GSK3377794","Ny-eso-1","Vaccine","Yes","['Ny-eso-1']","Yes","['Vaccine']","Phase 1",1,200,"Anticipated","2017-11-22","2032-04-01",{"$nulls":5},"This is a non-therapeutic, multi-center, long-term follow-up (LTFU) study of subjects who have, during the interventional study, received GSK3377794 generated by a process that utilizes lentiviral vectors. Subjects enrolled in the interventional studies who complete the interventional study or who withdraw from the interventional study will enter this LTFU study and will be followed for up to 15 years from the infusion of genetically modified T lymphocytes. Subjects can receive other therapies for their cancer while they are being followed for long term safety in this study.","This is a non-therapeutic, multi-center, LTFU study of subjects who have, in a previous GlaxoSmithKline (GSK) clinical trial, received GSK3377794 (NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T) by a process that utilizes lentiviral vectors. This protocol is designed in adherence with Food and Drug Administration (FDA) and European Medicines Agency (EMA) guidelines. The study involves up to 15 years post-infusion monitoring of subjects who have been exposed to lentivirus-mediated gene transfer in GSK clinical studies. Subjects will undergo clinical evaluation (i.e., new medical history, physical exam, adverse events, and exposure to mutagenic agents, anti-cancer therapies and investigational products in other clinical studies) with careful attention to adverse events possibly related to gene transfer or lentivirus-induced diseases. Blood samples will be collected for evaluating persistence of cells with lentiviral vector sequences, the detection of replication competent lentivirus (RCL), and chemistry and hematology laboratory assessments. Subjects will be followed for survival.","Long Term Follow-Up of Participants Exposed to GSK3377794 (NY-ESO-1c259 T), a Genetically Engineered NY-ESO-1 Specific T Cell Receptor",208750,"Neoplasms","Oncology Hematological Unspecified|Ear Cancer","Oncology Hematological|Oncology Solid Tumor","Oncology","Experimental","GSK3377794","Long term follow-up of subjects with solid or hematological malignancies who have received NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T in a previous trial","Genetic","GSK3377794 (NY-ESO-1&#x1D9C;&#xB2;&#x2075;&#x2079; T)","No study drug is administered in this study. Subjects who received NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T in a previous trial will be evaluated in this trial for long-term safety and efficacy.",null,"GSK3377794","\n\n * Subjects who have received at least one dose of GSK3377794 in the interventional study.\n * Subjects who have either completed the interventional study or have withdrawn from it.\n * Male or Female subjects.\n * Capable of giving signed informed consent prior to the study participation.\n\n","\n\n * None","NY-ESO-1",null,"Protein","Lung","Actual","2018-01-05","Actual","Anticipated","2032-04-01","Anticipated","2019-07-01","2018-01-02","2018-01-02","2019-07-17","No","Genetically engineered\nImmuno-oncology\nT Cell Therapy\nT Cell Receptor\nPreviously Treated\nCell Therapy\nSPEAR T Cell\nMetastatic\nSolid and Hematological Malignancies\nSafety\nLong Term Follow Up\nNY-ESO-1","Interventional","Other","Single Group Assignment","None (Open Label)","N/A","4 Years",null,"All",null,"No","Yes\nIPD for this study will be made available via the Clinical Study Data Request site.",{"$nulls":3},"Yes","No",{"$nulls":17},"ADP-0000-002","Adaptimmune Therapeutics","Number of subjects with delayed adverse events (AEs) associated with administration of autologous cells that have been genetically modified by lentiviral vectors","The following AEs will be reported:\n\n * New malignancies\n * New incidence or exacerbation of a pre-existing neurologic disorder\n * New incidence or exacerbation of a prior rheumatologic or other autoimmune disorder\n * New incidence of immune-related hematologic disorder\n * Serious infections (including opportunistic)\n * Unanticipated illness and/or hospitalization deemed related to gene modified cell therapy","15 years post last treatment","Number of subjects with Vesicular Stomatitis Virus G protein (VSV-G) DNA copies|Number of subjects with Woodchuck hepatitis virus posttranscriptional regulatory element (WPRE) or Psi DNA copies|Number of subjects with integrated vector sequences and vector integration patterns|Number of deaths|Time to death","Peripheral blood samples will be collected and tested for the presence of VSV-G DNA copies.|The persistence of genetically modified cells will be measured by detecting the presence of WPRE or Psi DNA in the peripheral blood samples.|Integrated vector sequences and vector integration patterns (e.g., polyclonal, oligoclonal, or monoclonal) will be identified in the peripheral blood samples.|Number of deaths will be summarized.|Time to death will be summarized.","15 years","GSKClinicalSupportHD@gsk.com","US GSK Clinical Trials Call Center","877-379-3718","Tampa, Florida, United States, 33612|Bethesda, Maryland, United States, 20892|Boston, Massachusetts, United States, 02215|Saint Louis, Missouri, United States, 63110|New York, New York, United States, 10065|Philadelphia, Pennsylvania, United States, 19104","Florida|Maryland|Massachusetts|Missouri|New York|Pennsylvania","United States","Gsk Investigational Site","GSKClinicalSupportHD@gsk.com","EU GSK Clinical Trials Call Center","+44 (0) 20 89904466","GSK Clinical Trials","2019-07-17","2020-05-25T16:35:23.542","2020-05-26T17:10:42.972","NCT03391778"]
["5ecbf3cbfe30261b1a0481b6","NCT03391778","2019-09-25","GlaxoSmithKline","GSK","Recruiting","Long Term Follow-Up of Subjects Exposed to GSK3377794","Ny-eso-1","Vaccine","Yes","['Ny-eso-1']","Yes","['Vaccine']","Phase 1",1,200,"Anticipated","2011-09-28","2032-04-01",{"$nulls":5},"This is a non-therapeutic, multi-center, long-term follow-up (LTFU) study of subjects who have, during the interventional study, received GSK3377794 generated by a process that utilizes lentiviral vectors. Subjects enrolled in the interventional studies who complete the interventional study or who withdraw from the interventional study will enter this LTFU study and will be followed for up to 15 years from the infusion of genetically modified T lymphocytes. Subjects can receive other therapies for their cancer while they are being followed for long term safety in this study.","This is a non-therapeutic, multi-center, LTFU study of subjects who have, in a previous GlaxoSmithKline (GSK) clinical trial, received GSK3377794 (NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T) by a process that utilizes lentiviral vectors. This protocol is designed in adherence with Food and Drug Administration (FDA) and European Medicines Agency (EMA) guidelines. The study involves up to 15 years post-infusion monitoring of subjects who have been exposed to lentivirus-mediated gene transfer in GSK clinical studies. Subjects will undergo clinical evaluation (i.e., new medical history, physical exam, adverse events, and exposure to mutagenic agents, anti-cancer therapies and investigational products in other clinical studies) with careful attention to adverse events possibly related to gene transfer or lentivirus-induced diseases. Blood samples will be collected for evaluating persistence of cells with lentiviral vector sequences, the detection of replication competent lentivirus (RCL), and chemistry and hematology laboratory assessments. Subjects will be followed for survival.","Long Term Follow-Up of Participants Exposed to GSK3377794 (NY-ESO-1c259 T), a Genetically Engineered NY-ESO-1 Specific T Cell Receptor",208750,"Neoplasms","Oncology Hematological Unspecified|Ear Cancer","Oncology Hematological|Oncology Solid Tumor","Oncology","Experimental","GSK3377794","Long term follow-up of subjects with solid or hematological malignancies who have received NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T in a previous trial","Genetic","GSK3377794 (NY-ESO-1&#x1D9C;&#xB2;&#x2075;&#x2079; T)","No study drug is administered in this study. Subjects who received NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T in a previous trial will be evaluated in this trial for long-term safety and efficacy.",null,"GSK3377794","\n\n * Subjects who have received at least one dose of GSK3377794 in the interventional study.\n * Subjects who have either completed the interventional study or have withdrawn from it.\n * Male or Female subjects.\n * Capable of giving signed informed consent prior to the study participation.\n\n","\n\n * None","NY-ESO-1",null,"Protein","Lung","Actual","2018-01-05","Actual","Anticipated","2032-04-01","Anticipated","2019-09-01","2018-01-02","2018-01-02","2019-09-24","No","Genetically engineered\nImmuno-oncology\nT Cell Therapy\nT Cell Receptor\nPreviously Treated\nCell Therapy\nSPEAR T Cell\nMetastatic\nSolid and Hematological Malignancies\nSafety\nLong Term Follow Up\nNY-ESO-1","Interventional","Other","Single Group Assignment","None (Open Label)","N/A","4 Years",null,"All",null,"No","Yes\nIPD for this study will be made available via the Clinical Study Data Request site.",{"$nulls":3},"Yes","No",{"$nulls":17},"ADP-0000-002","Adaptimmune Therapeutics","Number of subjects with delayed adverse events (AEs) associated with administration of autologous cells that have been genetically modified by lentiviral vectors","The following AEs will be reported:\n\n * New malignancies\n * New incidence or exacerbation of a pre-existing neurologic disorder\n * New incidence or exacerbation of a prior rheumatologic or other autoimmune disorder\n * New incidence of immune-related hematologic disorder\n * Serious infections (including opportunistic)\n * Unanticipated illness and/or hospitalization deemed related to gene modified cell therapy","15 years post last treatment","Number of subjects with Vesicular Stomatitis Virus G protein (VSV-G) DNA copies|Number of subjects with Woodchuck hepatitis virus posttranscriptional regulatory element (WPRE) or Psi DNA copies|Number of subjects with integrated vector sequences and vector integration patterns|Number of deaths|Time to death","Peripheral blood samples will be collected and tested for the presence of VSV-G DNA copies.|The persistence of genetically modified cells will be measured by detecting the presence of WPRE or Psi DNA in the peripheral blood samples.|Integrated vector sequences and vector integration patterns (e.g., polyclonal, oligoclonal, or monoclonal) will be identified in the peripheral blood samples.|Number of deaths will be summarized.|Time to death will be summarized.","15 years","GSKClinicalSupportHD@gsk.com","US GSK Clinical Trials Call Center","877-379-3718","Miami, Florida, United States, 33136|Baltimore, Maryland, United States, 21201|Boston, Massachusetts, United States, 02215|Saint Louis, Missouri, United States, 63110|New York, New York, United States, 10065|Philadelphia, Pennsylvania, United States, 19104|Nashville, Tennessee, United States, 37203","Florida|Maryland|Massachusetts|Missouri|New York|Pennsylvania|Tennessee","United States","Gsk Investigational Site","GSKClinicalSupportHD@gsk.com","EU GSK Clinical Trials Call Center","+44 (0) 20 89904466","GSK Clinical Trials","2019-09-24","2020-05-25T16:35:23.891","2020-05-26T17:10:42.972","NCT03391778"]
["5ecbf3cbe2561b1b11905cb2","NCT03391778","2019-10-16","GlaxoSmithKline","GSK","Recruiting","Long Term Follow-Up of Subjects Exposed to GSK3377794","Ny-eso-1","Vaccine","Yes","['Ny-eso-1']","Yes","['Vaccine']","Phase 1",1,200,"Anticipated","2011-09-28","2032-04-01",{"$nulls":5},"This is a non-therapeutic, multi-center, long-term follow-up (LTFU) study of subjects who have, during the interventional study, received GSK3377794 generated by a process that utilizes lentiviral vectors. Subjects enrolled in the interventional studies who complete the interventional study or who withdraw from the interventional study will enter this LTFU study and will be followed for up to 15 years from the infusion of genetically modified T lymphocytes. Subjects can receive other therapies for their cancer while they are being followed for long term safety in this study.","This is a non-therapeutic, multi-center, LTFU study of subjects who have, in a previous GlaxoSmithKline (GSK) clinical trial, received GSK3377794 (NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T) by a process that utilizes lentiviral vectors. This protocol is designed in adherence with Food and Drug Administration (FDA) and European Medicines Agency (EMA) guidelines. The study involves up to 15 years post-infusion monitoring of subjects who have been exposed to lentivirus-mediated gene transfer in GSK clinical studies. Subjects will undergo clinical evaluation (i.e., new medical history, physical exam, adverse events, and exposure to mutagenic agents, anti-cancer therapies and investigational products in other clinical studies) with careful attention to adverse events possibly related to gene transfer or lentivirus-induced diseases. Blood samples will be collected for evaluating persistence of cells with lentiviral vector sequences, the detection of replication competent lentivirus (RCL), and chemistry and hematology laboratory assessments. Subjects will be followed for survival.","Long Term Follow-Up of Participants Exposed to GSK3377794 (NY-ESO-1c259 T), a Genetically Engineered NY-ESO-1 Specific T Cell Receptor",208750,"Neoplasms","Oncology Hematological Unspecified|Ear Cancer","Oncology Hematological|Oncology Solid Tumor","Oncology","Experimental","GSK3377794","Long term follow-up of subjects with solid or hematological malignancies who have received NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T in a previous trial","Genetic","GSK3377794 (NY-ESO-1&#x1D9C;&#xB2;&#x2075;&#x2079; T)","No study drug is administered in this study. Subjects who received NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T in a previous trial will be evaluated in this trial for long-term safety and efficacy.",null,"GSK3377794","\n\n * Subjects who have received at least one dose of GSK3377794 in the interventional study.\n * Subjects who have either completed the interventional study or have withdrawn from it.\n * Male or Female subjects.\n * Capable of giving signed informed consent prior to the study participation.\n\n","\n\n * None","NY-ESO-1",null,"Protein","Lung","Actual","2018-01-05","Actual","Anticipated","2032-04-01","Anticipated","2019-10-01","2018-01-02","2018-01-02","2019-10-15","No","Genetically engineered\nImmuno-oncology\nT Cell Therapy\nT Cell Receptor\nPreviously Treated\nCell Therapy\nSPEAR T Cell\nMetastatic\nSolid and Hematological Malignancies\nSafety\nLong Term Follow Up\nNY-ESO-1","Interventional","Other","Single Group Assignment","None (Open Label)","N/A","4 Years",null,"All",null,"No","Yes\nIPD for this study will be made available via the Clinical Study Data Request site.",{"$nulls":3},"Yes","No",{"$nulls":17},"ADP-0000-002","Adaptimmune Therapeutics","Number of subjects with delayed adverse events (AEs) associated with administration of autologous cells that have been genetically modified by lentiviral vectors","The following AEs will be reported:\n\n * New malignancies\n * New incidence or exacerbation of a pre-existing neurologic disorder\n * New incidence or exacerbation of a prior rheumatologic or other autoimmune disorder\n * New incidence of immune-related hematologic disorder\n * Serious infections (including opportunistic)\n * Unanticipated illness and/or hospitalization deemed related to gene modified cell therapy","15 years post last treatment","Number of subjects with Vesicular Stomatitis Virus G protein (VSV-G) DNA copies|Number of subjects with Woodchuck hepatitis virus posttranscriptional regulatory element (WPRE) or Psi DNA copies|Number of subjects with integrated vector sequences and vector integration patterns|Number of deaths|Time to death","Peripheral blood samples will be collected and tested for the presence of VSV-G DNA copies.|The persistence of genetically modified cells will be measured by detecting the presence of WPRE or Psi DNA in the peripheral blood samples.|Integrated vector sequences and vector integration patterns (e.g., polyclonal, oligoclonal, or monoclonal) will be identified in the peripheral blood samples.|Number of deaths will be summarized.|Time to death will be summarized.","15 years","GSKClinicalSupportHD@gsk.com","US GSK Clinical Trials Call Center","877-379-3718","Miami, Florida, United States, 33136|Baltimore, Maryland, United States, 21201|Boston, Massachusetts, United States, 02215|Saint Louis, Missouri, United States, 63110|New York, New York, United States, 10022|Philadelphia, Pennsylvania, United States, 19104|Nashville, Tennessee, United States, 37203","Florida|Maryland|Massachusetts|Missouri|New York|Pennsylvania|Tennessee","United States","Gsk Investigational Site","GSKClinicalSupportHD@gsk.com","EU GSK Clinical Trials Call Center","+44 (0) 20 89904466","GSK Clinical Trials","2019-10-15","2020-05-25T16:35:23.964","2020-05-26T17:10:42.972","NCT03391778"]
["5ecbf3ccfe30261b1a0481b7","NCT03391778","2020-01-13","GlaxoSmithKline","GSK","Recruiting","Long Term Follow-Up of Subjects Exposed to GSK3377794","Ny-eso-1","Vaccine","Yes","['Ny-eso-1']","Yes","['Vaccine']","Phase 1",1,200,"Anticipated","2011-09-28","2032-04-01",{"$nulls":5},"This is a non-therapeutic, multi-center, long-term follow-up (LTFU) study of subjects who have, during the interventional study, received GSK3377794 generated by a process that utilizes lentiviral vectors. Subjects enrolled in the interventional studies who complete the interventional study or who withdraw from the interventional study will enter this LTFU study and will be followed for up to 15 years from the infusion of genetically modified T lymphocytes. Subjects can receive other therapies for their cancer while they are being followed for long term safety in this study.","This is a non-therapeutic, multi-center, LTFU study of subjects who have, in a previous GlaxoSmithKline (GSK) clinical trial, received GSK3377794 (NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T) by a process that utilizes lentiviral vectors. This protocol is designed in adherence with Food and Drug Administration (FDA) and European Medicines Agency (EMA) guidelines. The study involves up to 15 years post-infusion monitoring of subjects who have been exposed to lentivirus-mediated gene transfer in GSK clinical studies. Subjects will undergo clinical evaluation (i.e., new medical history, physical exam, adverse events, and exposure to mutagenic agents, anti-cancer therapies and investigational products in other clinical studies) with careful attention to adverse events possibly related to gene transfer or lentivirus-induced diseases. Blood samples will be collected for evaluating persistence of cells with lentiviral vector sequences, the detection of replication competent lentivirus (RCL), and chemistry and hematology laboratory assessments. Subjects will be followed for survival.","Long Term Follow-Up of Participants Exposed to GSK3377794 (NY-ESO-1c259 T), a Genetically Engineered NY-ESO-1 Specific T Cell Receptor",208750,"Neoplasms","Oncology Hematological Unspecified|Ear Cancer","Oncology Hematological|Oncology Solid Tumor","Oncology","Experimental","GSK3377794","Long term follow-up of subjects with solid or hematological malignancies who have received NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T in a previous trial","Genetic","GSK3377794 (NY-ESO-1&#x1D9C;&#xB2;&#x2075;&#x2079; T)","No study drug is administered in this study. Subjects who received NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T in a previous trial will be evaluated in this trial for long-term safety and efficacy.",null,"GSK3377794","\n\n * Subjects who have received at least one dose of GSK3377794 in the interventional study.\n * Subjects who have either completed the interventional study or have withdrawn from it.\n * Male or Female subjects.\n * Capable of giving signed informed consent prior to the study participation.\n\n","\n\n * None","NY-ESO-1",null,"Protein","Lung","Actual","2018-01-05","Actual","Anticipated","2032-04-01","Anticipated","2020-01-01","2018-01-02","2018-01-02","2020-01-08","No","Genetically engineered\nImmuno-oncology\nT Cell Therapy\nT Cell Receptor\nPreviously Treated\nCell Therapy\nSPEAR T Cell\nMetastatic\nSolid and Hematological Malignancies\nSafety\nLong Term Follow Up\nNY-ESO-1","Interventional","Other","Single Group Assignment","None (Open Label)","N/A","4 Years",null,"All",null,"No","Yes\nIPD for this study will be made available via the Clinical Study Data Request site.",{"$nulls":3},"Yes","No",{"$nulls":17},"ADP-0000-002","Adaptimmune Therapeutics","Number of subjects with delayed adverse events (AEs) associated with administration of autologous cells that have been genetically modified by lentiviral vectors","The following AEs will be reported:\n\n * New malignancies\n * New incidence or exacerbation of a pre-existing neurologic disorder\n * New incidence or exacerbation of a prior rheumatologic or other autoimmune disorder\n * New incidence of immune-related hematologic disorder\n * Serious infections (including opportunistic)\n * Unanticipated illness and/or hospitalization deemed related to gene modified cell therapy","15 years post last treatment","Number of subjects with Vesicular Stomatitis Virus G protein (VSV-G) DNA copies|Number of subjects with Woodchuck hepatitis virus posttranscriptional regulatory element (WPRE) or Psi DNA copies|Number of subjects with integrated vector sequences and vector integration patterns|Number of deaths|Time to death","Peripheral blood samples will be collected and tested for the presence of VSV-G DNA copies.|The persistence of genetically modified cells will be measured by detecting the presence of WPRE or Psi DNA in the peripheral blood samples.|Integrated vector sequences and vector integration patterns (e.g., polyclonal, oligoclonal, or monoclonal) will be identified in the peripheral blood samples.|Number of deaths will be summarized.|Time to death will be summarized.","15 years","GSKClinicalSupportHD@gsk.com","US GSK Clinical Trials Call Center","877-379-3718","Duarte, California, United States, 91010|Miami, Florida, United States, 33136|Baltimore, Maryland, United States, 21201|Boston, Massachusetts, United States, 02215|Saint Louis, Missouri, United States, 63110|New York, New York, United States, 10065|Philadelphia, Pennsylvania, United States, 19104|Nashville, Tennessee, United States, 37203|Houston, Texas, United States, 77030","California|Florida|Maryland|Massachusetts|Missouri|New York|Pennsylvania|Tennessee|Texas","United States","Gsk Investigational Site","GSKClinicalSupportHD@gsk.com","EU GSK Clinical Trials Call Center","+44 (0) 20 89904466","GSK Clinical Trials","2020-01-08","2020-05-25T16:35:24.072","2020-05-26T17:10:42.972","NCT03391778"]
["5ecbf3ccfeab101b155307e7","NCT03391778","2020-02-10","GlaxoSmithKline","GSK","Recruiting","Long Term Follow-Up of Subjects Exposed to GSK3377794","Ny-eso-1","Vaccine","Yes","['Ny-eso-1']","Yes","['Vaccine']","Phase 1",1,200,"Anticipated","2011-09-28","2032-04-01",{"$nulls":5},"This is a non-therapeutic, multi-center, long-term follow-up (LTFU) study of subjects who have, during the interventional study, received GSK3377794 generated by a process that utilizes lentiviral vectors. Subjects enrolled in the interventional studies who complete the interventional study or who withdraw from the interventional study will enter this LTFU study and will be followed for up to 15 years from the infusion of genetically modified T lymphocytes. Subjects can receive other therapies for their cancer while they are being followed for long term safety in this study.","This is a non-therapeutic, multi-center, LTFU study of subjects who have, in a previous GlaxoSmithKline (GSK) clinical trial, received GSK3377794 (NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T) by a process that utilizes lentiviral vectors. This protocol is designed in adherence with Food and Drug Administration (FDA) and European Medicines Agency (EMA) guidelines. The study involves up to 15 years post-infusion monitoring of subjects who have been exposed to lentivirus-mediated gene transfer in GSK clinical studies. Subjects will undergo clinical evaluation (i.e., new medical history, physical exam, adverse events, and exposure to mutagenic agents, anti-cancer therapies and investigational products in other clinical studies) with careful attention to adverse events possibly related to gene transfer or lentivirus-induced diseases. Blood samples will be collected for evaluating persistence of cells with lentiviral vector sequences, the detection of replication competent lentivirus (RCL), and chemistry and hematology laboratory assessments. Subjects will be followed for survival.","Long Term Follow-Up of Participants Exposed to GSK3377794 (NY-ESO-1c259 T), a Genetically Engineered NY-ESO-1 Specific T Cell Receptor",208750,"Neoplasms","Oncology Hematological Unspecified|Ear Cancer","Oncology Hematological|Oncology Solid Tumor","Oncology","Experimental","GSK3377794","Long term follow-up of subjects with solid or hematological malignancies who have received NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T in a previous trial","Genetic","GSK3377794 (NY-ESO-1&#x1D9C;&#xB2;&#x2075;&#x2079; T)","No study drug is administered in this study. Subjects who received NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T in a previous trial will be evaluated in this trial for long-term safety and efficacy.",null,"GSK3377794","\n\n * Subjects who have received at least one dose of GSK3377794 in the interventional study.\n * Subjects who have either completed the interventional study or have withdrawn from it.\n * Male or Female subjects.\n * Capable of giving signed informed consent prior to the study participation.\n\n","\n\n * None","NY-ESO-1",null,"Protein","Lung","Actual","2018-01-05","Actual","Anticipated","2032-04-01","Anticipated","2020-02-01","2018-01-02","2018-01-02","2020-02-07","No","Genetically engineered\nImmuno-oncology\nT Cell Therapy\nT Cell Receptor\nPreviously Treated\nCell Therapy\nSPEAR T Cell\nMetastatic\nSolid and Hematological Malignancies\nSafety\nLong Term Follow Up\nNY-ESO-1","Interventional","Other","Single Group Assignment","None (Open Label)","N/A","4 Years",null,"All",null,"No","Yes\nIPD for this study will be made available via the Clinical Study Data Request site.",{"$nulls":3},"Yes","No",{"$nulls":17},"ADP-0000-002","Adaptimmune Therapeutics","Number of subjects with delayed adverse events (AEs) associated with administration of autologous cells that have been genetically modified by lentiviral vectors","The following AEs will be reported:\n\n * New malignancies\n * New incidence or exacerbation of a pre-existing neurologic disorder\n * New incidence or exacerbation of a prior rheumatologic or other autoimmune disorder\n * New incidence of immune-related hematologic disorder\n * Serious infections (including opportunistic)\n * Unanticipated illness and/or hospitalization deemed related to gene modified cell therapy","15 years post last treatment","Number of subjects with Vesicular Stomatitis Virus G protein (VSV-G) DNA copies|Number of subjects with Woodchuck hepatitis virus posttranscriptional regulatory element (WPRE) or Psi DNA copies|Number of subjects with integrated vector sequences and vector integration patterns|Number of deaths|Time to death","Peripheral blood samples will be collected and tested for the presence of VSV-G DNA copies.|The persistence of genetically modified cells will be measured by detecting the presence of WPRE or Psi DNA in the peripheral blood samples.|Integrated vector sequences and vector integration patterns (e.g., polyclonal, oligoclonal, or monoclonal) will be identified in the peripheral blood samples.|Number of deaths will be summarized.|Time to death will be summarized.","15 years","GSKClinicalSupportHD@gsk.com","US GSK Clinical Trials Call Center","877-379-3718","Toronto, Ontario, Canada, M5G 2M9|Duarte, California, United States, 91010|Miami, Florida, United States, 33136|Baltimore, Maryland, United States, 21201|Boston, Massachusetts, United States, 02215|Saint Louis, Missouri, United States, 63110|New York, New York, United States, 10065|Philadelphia, Pennsylvania, United States, 19104|Nashville, Tennessee, United States, 37203|Houston, Texas, United States, 77030","California|Florida|Maryland|Massachusetts|Missouri|New York|Pennsylvania|Tennessee|Texas","Canada|United States","Ontario Gsk Investigational Site|Gsk Investigational Site","GSKClinicalSupportHD@gsk.com","EU GSK Clinical Trials Call Center","+44 (0) 20 89904466","GSK Clinical Trials","2020-02-07","2020-05-25T16:35:24.212","2020-05-26T17:10:42.972","NCT03391778"]
["5ecbf3cc307e3d1b1f8d9c47","NCT03391778","2020-02-18","GlaxoSmithKline","GSK","Recruiting","Long Term Follow-Up of Subjects Exposed to GSK3377794","Ny-eso-1","Vaccine","Yes","['Ny-eso-1']","Yes","['Vaccine']","Phase 1",1,200,"Anticipated","2011-09-28","2032-04-01",{"$nulls":5},"This is a non-therapeutic, multi-center, long-term follow-up (LTFU) study of subjects who have, during the interventional study, received GSK3377794 generated by a process that utilizes lentiviral vectors. Subjects enrolled in the interventional studies who complete the interventional study or who withdraw from the interventional study will enter this LTFU study and will be followed for up to 15 years from the infusion of genetically modified T lymphocytes. Subjects can receive other therapies for their cancer while they are being followed for long term safety in this study.","This is a non-therapeutic, multi-center, LTFU study of subjects who have, in a previous GlaxoSmithKline (GSK) clinical trial, received GSK3377794 (NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T) by a process that utilizes lentiviral vectors. This protocol is designed in adherence with Food and Drug Administration (FDA) and European Medicines Agency (EMA) guidelines. The study involves up to 15 years post-infusion monitoring of subjects who have been exposed to lentivirus-mediated gene transfer in GSK clinical studies. Subjects will undergo clinical evaluation (i.e., new medical history, physical exam, adverse events, and exposure to mutagenic agents, anti-cancer therapies and investigational products in other clinical studies) with careful attention to adverse events possibly related to gene transfer or lentivirus-induced diseases. Blood samples will be collected for evaluating persistence of cells with lentiviral vector sequences, the detection of replication competent lentivirus (RCL), and chemistry and hematology laboratory assessments. Subjects will be followed for survival.","Long Term Follow-Up of Participants Exposed to GSK3377794 (NY-ESO-1c259 T), a Genetically Engineered NY-ESO-1 Specific T Cell Receptor",208750,"Neoplasms","Oncology Hematological Unspecified|Ear Cancer","Oncology Hematological|Oncology Solid Tumor","Oncology","Experimental","GSK3377794","Long term follow-up of subjects with solid or hematological malignancies who have received NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T in a previous trial","Genetic","GSK3377794 (NY-ESO-1&#x1D9C;&#xB2;&#x2075;&#x2079; T)","No study drug is administered in this study. Subjects who received NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T in a previous trial will be evaluated in this trial for long-term safety and efficacy.",null,"GSK3377794","\n\n * Subjects who have received at least one dose of GSK3377794 in the interventional study.\n * Subjects who have either completed the interventional study or have withdrawn from it.\n * Male or Female subjects.\n * Capable of giving signed informed consent prior to the study participation.\n\n","\n\n * None","NY-ESO-1",null,"Protein","Lung","Actual","2018-01-05","Actual","Anticipated","2032-04-01","Anticipated","2020-02-01","2018-01-02","2018-01-02","2020-02-14","No","Genetically engineered\nImmuno-oncology\nT Cell Therapy\nT Cell Receptor\nPreviously Treated\nCell Therapy\nSPEAR T Cell\nMetastatic\nSolid and Hematological Malignancies\nSafety\nLong Term Follow Up\nNY-ESO-1","Interventional","Other","Single Group Assignment","None (Open Label)","N/A","4 Years",null,"All",null,"No","Yes\nIPD for this study will be made available via the Clinical Study Data Request site.",{"$nulls":3},"Yes","No",{"$nulls":17},"ADP-0000-002","Adaptimmune Therapeutics","Number of subjects with delayed adverse events (AEs) associated with administration of autologous cells that have been genetically modified by lentiviral vectors","The following AEs will be reported:\n\n * New malignancies\n * New incidence or exacerbation of a pre-existing neurologic disorder\n * New incidence or exacerbation of a prior rheumatologic or other autoimmune disorder\n * New incidence of immune-related hematologic disorder\n * Serious infections (including opportunistic)\n * Unanticipated illness and/or hospitalization deemed related to gene modified cell therapy","15 years post last treatment","Number of subjects with Vesicular Stomatitis Virus G protein (VSV-G) DNA copies|Number of subjects with Woodchuck hepatitis virus posttranscriptional regulatory element (WPRE) or Psi DNA copies|Number of subjects with integrated vector sequences and vector integration patterns|Number of deaths|Time to death","Peripheral blood samples will be collected and tested for the presence of VSV-G DNA copies.|The persistence of genetically modified cells will be measured by detecting the presence of WPRE or Psi DNA in the peripheral blood samples.|Integrated vector sequences and vector integration patterns (e.g., polyclonal, oligoclonal, or monoclonal) will be identified in the peripheral blood samples.|Number of deaths will be summarized.|Time to death will be summarized.","15 years","GSKClinicalSupportHD@gsk.com","US GSK Clinical Trials Call Center","877-379-3718","Toronto, Ontario, Canada, M5G 2M9|Duarte, California, United States, 91010|Miami, Florida, United States, 33136|Baltimore, Maryland, United States, 21201|Boston, Massachusetts, United States, 02215|Saint Louis, Missouri, United States, 63110|New York, New York, United States, 10065|Philadelphia, Pennsylvania, United States, 19104|Nashville, Tennessee, United States, 37203|Houston, Texas, United States, 77030","California|Florida|Maryland|Massachusetts|Missouri|New York|Pennsylvania|Tennessee|Texas","Canada|United States","Ontario Gsk Investigational Site|Gsk Investigational Site","GSKClinicalSupportHD@gsk.com","EU GSK Clinical Trials Call Center","+44 (0) 20 89904466","GSK Clinical Trials","2020-02-14","2020-05-25T16:35:24.081","2020-05-26T17:10:42.972","NCT03391778"]
["5ecbf3cc11702c1b1b9169cb","NCT03391778","2020-03-24","GlaxoSmithKline","GSK","Recruiting","Long Term Follow-Up of Subjects Exposed to GSK3377794","Ny-eso-1","Vaccine","Yes","['Ny-eso-1']","Yes","['Vaccine']","Phase 1",1,444,"Anticipated","2011-09-28","2032-04-01",{"$nulls":5},"This is a non-therapeutic, multi-center, long-term follow-up (LTFU) study of subjects who have, during the interventional study, received GSK3377794 generated by a process that utilizes lentiviral vectors. Subjects enrolled in the interventional studies who complete the interventional study or who withdraw from the interventional study will enter this LTFU study and will be followed for up to 15 years from the infusion of genetically modified T lymphocytes. Subjects can receive other therapies for their cancer while they are being followed for long term safety in this study.","This is a non-therapeutic, multi-center, LTFU study of subjects who have, in a previous GlaxoSmithKline (GSK) clinical trial, received GSK3377794 (NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T) by a process that utilizes lentiviral vectors. This protocol is designed in adherence with Food and Drug Administration (FDA) and European Medicines Agency (EMA) guidelines. The study involves up to 15 years post-infusion monitoring of subjects who have been exposed to lentivirus-mediated gene transfer in GSK clinical studies. Subjects will undergo clinical evaluation (i.e., new medical history, physical exam, adverse events, and exposure to mutagenic agents, anti-cancer therapies and investigational products in other clinical studies) with careful attention to adverse events possibly related to gene transfer or lentivirus-induced diseases. Blood samples will be collected for evaluating persistence of cells with lentiviral vector sequences, the detection of replication competent lentivirus (RCL), and chemistry and hematology laboratory assessments. Subjects will be followed for survival.","Long Term Follow-Up of Participants Exposed to GSK3377794 (NY-ESO-1c259 T), a Genetically Engineered NY-ESO-1 Specific T Cell Receptor",208750,"Neoplasms","Oncology Hematological Unspecified|Ear Cancer","Oncology Hematological|Oncology Solid Tumor","Oncology","Experimental","GSK3377794","Long term follow-up of subjects with solid or hematological malignancies who have received NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T in a previous trial","Genetic","GSK3377794 (NY-ESO-1&#x1D9C;&#xB2;&#x2075;&#x2079; T)","No study drug is administered in this study. Subjects who received NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T in a previous trial will be evaluated in this trial for long-term safety and efficacy.",null,"GSK3377794","\n\n * Subjects who have received at least one dose of GSK3377794 in the interventional study.\n * Subjects who have either completed the interventional study or have withdrawn from it.\n * Male or Female subjects.\n * Capable of giving signed informed consent prior to the study participation.\n\n","\n\n * None","NY-ESO-1",null,"Protein","Lung","Actual","2018-01-05","Actual","Anticipated","2032-04-01","Anticipated","2020-03-01","2018-01-02","2018-01-02","2020-03-22","No","Genetically engineered\nImmuno-oncology\nT Cell Therapy\nT Cell Receptor\nPreviously Treated\nCell Therapy\nSPEAR T Cell\nMetastatic\nSolid and Hematological Malignancies\nSafety\nLong Term Follow Up\nNY-ESO-1","Interventional","Other","Single Group Assignment","None (Open Label)","N/A","4 Years",null,"All",null,"No","Yes\nIPD for this study will be made available via the Clinical Study Data Request site.",{"$nulls":3},"Yes","No",{"$nulls":17},"ADP-0000-002","Adaptimmune Therapeutics","Number of subjects with delayed adverse events (AEs) associated with administration of autologous cells that have been genetically modified by lentiviral vectors","The following AEs will be reported:\n\n * New malignancies\n * New incidence or exacerbation of a pre-existing neurologic disorder\n * New incidence or exacerbation of a prior rheumatologic or other autoimmune disorder\n * New incidence of immune-related hematologic disorder\n * Serious infections (including opportunistic)\n * Unanticipated illness and/or hospitalization deemed related to gene modified cell therapy","15 years post last treatment","Number of subjects with Vesicular Stomatitis Virus G protein (VSV-G) DNA copies|Number of subjects with Woodchuck hepatitis virus posttranscriptional regulatory element (WPRE) or Psi DNA copies|Number of subjects with integrated vector sequences and vector integration patterns|Number of deaths|Time to death","Peripheral blood samples will be collected and tested for the presence of VSV-G DNA copies.|The persistence of genetically modified cells will be measured by detecting the presence of WPRE or Psi DNA in the peripheral blood samples.|Integrated vector sequences and vector integration patterns (e.g., polyclonal, oligoclonal, or monoclonal) will be identified in the peripheral blood samples.|Number of deaths will be summarized.|Time to death will be summarized.","15 years","GSKClinicalSupportHD@gsk.com","US GSK Clinical Trials Call Center","877-379-3718","Toronto, Ontario, Canada, M5G 2M9|Duarte, California, United States, 91010|Denver, Colorado, United States, 80218|Miami, Florida, United States, 33136|Baltimore, Maryland, United States, 21201|Boston, Massachusetts, United States, 02215|Saint Louis, Missouri, United States, 63110|New York, New York, United States, 10065|Philadelphia, Pennsylvania, United States, 19104|Nashville, Tennessee, United States, 37203|Houston, Texas, United States, 77030","California|Colorado|Florida|Maryland|Massachusetts|Missouri|New York|Pennsylvania|Tennessee|Texas","Canada|United States","Ontario Gsk Investigational Site|Gsk Investigational Site","GSKClinicalSupportHD@gsk.com","EU GSK Clinical Trials Call Center","+44 (0) 20 89904466","GSK Clinical Trials","2020-03-22","2020-05-25T16:35:24.240","2020-05-26T17:10:42.972","NCT03391778"]
["5ecbf3cce2561b1b11905cb3","NCT03391778","2020-05-07","GlaxoSmithKline","GSK","Recruiting","Long Term Follow-Up of Subjects Exposed to GSK3377794","Ny-eso-1","Vaccine","Yes","['Ny-eso-1']","Yes","['Vaccine']","Phase 1",1,444,"Anticipated","2017-11-22","2032-04-01",{"$nulls":5},"This is a non-therapeutic, multi-center, long-term follow-up (LTFU) study of subjects who have, during the interventional study, received GSK3377794 generated by a process that utilizes lentiviral vectors. Subjects enrolled in the interventional studies who complete the interventional study or who withdraw from the interventional study will enter this LTFU study and will be followed for up to 15 years from the infusion of genetically modified T lymphocytes. Subjects can receive other therapies for their cancer while they are being followed for long term safety in this study.","This is a non-therapeutic, multi-center, LTFU study of subjects who have, in a previous GlaxoSmithKline (GSK) clinical trial, received GSK3377794 (NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T) by a process that utilizes lentiviral vectors. This protocol is designed in adherence with Food and Drug Administration (FDA) and European Medicines Agency (EMA) guidelines. The study involves up to 15 years post-infusion monitoring of subjects who have been exposed to lentivirus-mediated gene transfer in GSK clinical studies. Subjects will undergo clinical evaluation (i.e., new medical history, physical exam, adverse events, and exposure to mutagenic agents, anti-cancer therapies and investigational products in other clinical studies) with careful attention to adverse events possibly related to gene transfer or lentivirus-induced diseases. Blood samples will be collected for evaluating persistence of cells with lentiviral vector sequences, the detection of replication competent lentivirus (RCL), and chemistry and hematology laboratory assessments. Subjects will be followed for survival.","Long Term Follow-Up of Participants Exposed to GSK3377794 (NY-ESO-1c259 T), a Genetically Engineered NY-ESO-1 Specific T Cell Receptor",208750,"Neoplasms","Oncology Hematological Unspecified|Ear Cancer","Oncology Hematological|Oncology Solid Tumor","Oncology","Experimental","GSK3377794","Long term follow-up of subjects with solid or hematological malignancies who have received NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T in a previous trial","Genetic","GSK3377794 (NY-ESO-1&#x1D9C;&#xB2;&#x2075;&#x2079; T)","No study drug is administered in this study. Subjects who received NY-ESO-1á¶œÂ²â\u0081µâ\u0081¹T in a previous trial will be evaluated in this trial for long-term safety and efficacy.",null,"GSK3377794","\n\n * Subjects who have received at least one dose of GSK3377794 in the interventional study.\n * Subjects who have either completed the interventional study or have withdrawn from it.\n * Male or Female subjects.\n * Capable of giving signed informed consent prior to the study participation.\n\n","\n\n * None","NY-ESO-1",null,"Protein","Lung","Actual","2018-01-05","Actual","Anticipated","2032-04-01","Anticipated","2020-05-01","2018-01-02","2018-01-02","2020-05-06","No","Genetically engineered\nImmuno-oncology\nT Cell Therapy\nT Cell Receptor\nPreviously Treated\nCell Therapy\nSPEAR T Cell\nMetastatic\nSolid and Hematological Malignancies\nSafety\nLong Term Follow Up\nNY-ESO-1","Interventional","Other","Single Group Assignment","None (Open Label)","N/A","4 Years",null,"All",null,"No","Yes\nIPD for this study will be made available via the Clinical Study Data Request site.",{"$nulls":3},"Yes","No",{"$nulls":17},"ADP-0000-002","Adaptimmune Therapeutics","Number of subjects with delayed adverse events (AEs) associated with administration of autologous cells that have been genetically modified by lentiviral vectors","The following AEs will be reported:\n\n * New malignancies\n * New incidence or exacerbation of a pre-existing neurologic disorder\n * New incidence or exacerbation of a prior rheumatologic or other autoimmune disorder\n * New incidence of immune-related hematologic disorder\n * Serious infections (including opportunistic)\n * Unanticipated illness and/or hospitalization deemed related to gene modified cell therapy","15 years post last treatment","Number of subjects with Vesicular Stomatitis Virus G protein (VSV-G) DNA copies|Number of subjects with Woodchuck hepatitis virus posttranscriptional regulatory element (WPRE) or Psi DNA copies|Number of subjects with integrated vector sequences and vector integration patterns|Number of deaths|Time to death","Peripheral blood samples will be collected and tested for the presence of VSV-G DNA copies.|The persistence of genetically modified cells will be measured by detecting the presence of WPRE or Psi DNA in the peripheral blood samples.|Integrated vector sequences and vector integration patterns (e.g., polyclonal, oligoclonal, or monoclonal) will be identified in the peripheral blood samples.|Number of deaths will be summarized.|Time to death will be summarized.","15 years","GSKClinicalSupportHD@gsk.com","US GSK Clinical Trials Call Center","877-379-3718","Toronto, Ontario, Canada, M5G 2M9|Duarte, California, United States, 91010|Denver, Colorado, United States, 80218|Miami, Florida, United States, 33136|Atlanta, Georgia, United States, 30322|Baltimore, Maryland, United States, 21201|Boston, Massachusetts, United States, 02215|Saint Louis, Missouri, United States, 63110|New York, New York, United States, 10065|Philadelphia, Pennsylvania, United States, 19104|Nashville, Tennessee, United States, 37203|Houston, Texas, United States, 77030","California|Colorado|Florida|Georgia|Maryland|Massachusetts|Missouri|New York|Pennsylvania|Tennessee|Texas","Canada|United States","Ontario Gsk Investigational Site|Gsk Investigational Site","GSKClinicalSupportHD@gsk.com","EU GSK Clinical Trials Call Center","+44 (0) 20 89904466","GSK Clinical Trials","2020-05-06","2020-05-25T16:35:24.299","2020-05-26T17:10:42.972","NCT03391778"]
["5ecbf3cd11702c1b1b9169cd","NCT03391804","2018-01-05","Allena","ALNA","Not yet recruiting","Study of ALLN-177 in Patients Aged 12 Years or Older With Enteric or Primary Hyperoxaluria and Hyperoxalemia","Alln-177",null,"Yes","['Alln-177']","Unknown",null,"Phase 2",1,20,"Anticipated","2018-03-01","2019-06-01",{"$nulls":5},"Evaluate the efficacy and safety of ALLN-177 in adult and pediatric patients with enteric or primary hyperoxaluria and hyperoxalemia","Phase 2, multi-center, open label, single arm study to evaluate the effect and safety of ALLN-177 in adult and pediatric patients aged 12 and older with enteric or primary hyperoxaluria and hyperoxalemia.\n\nApproximately 15-20 evaluable subjects are planned to be enrolled in the study. Eligible subjects will administer ALLN-177 with each meal/snack 5 times per day for 12 consecutive weeks.","Pilot Study of ALLN-177 in Adult and Pediatric Subjects Aged 12 Years or Older With Enteric or Primary Hyperoxaluria and Hyperoxalemia","ALLN-177-206","Enteric Hyperoxaluria\nPrimary Hyperoxaluria\nHyperoxalemia","Hyperoxaluria|Hyperoxaluria, Primary","Urologic Diseases","Reproductive and Urogenital","Experimental","ALLN-177","ALLN-177 7,500 units (2 capsules)","Drug","ALLN-177","ALLN-177 7,500 units (2 capsules) with each meal/snack by mouth 5 times per day","Oxalate decarboxylase","ALLN-177","\n\n 1. Signed a informed consent form or an assent\n 2. Aged 12 or older with body weight â‰¥ 35kg\n 3. History of primary hyperoxaluria or hyperoxaluria secondary to a known underlying enteric disorder associated with malabsorption (e.g., bariatric surgery, Crohn's disease, bowel surgery, short bowel syndrome, or other malabsorption syndrome)\n 4. Urinary Oxalate â‰¥ 40mg/24h (Pediatric is normalized for body surface area)\n 5. Glomerular filtration rate <45 mL/ min/1.73 m2 at Screening, or has been on dialysis for greater than 3 months but less than 2 years\n 6. Plasma oxalate >5 Âµmol/L\n\n","\n\n1. Unable or unwilling to discontinue Vitamin C supplementation",{"$nulls":4},"Actual","2018-01-05","Actual","Anticipated","2019-12-01","Anticipated","2017-12-01","2018-01-02","2018-01-04","2018-01-04","No","Oxalate\nKidney Stones\noxalate nephropathy\nsystemic oxalosis","Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","12 Years",null,"All",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":17},"2017-003547-38","EudraCT Number","Change in plasma oxalate","Efficacy will be assessed based on change from baseline in plasma oxalate","on 12 weeks of treatment","Change in 24-hr urinary oxalate excretion","Efficacy will be assessed based on change from baseline in 24-hr urinary oxalate excretion","on 12 weeks of treatment","clinical206@allenapharma.com","Allena Communication Center","617-467-4577",{"$nulls":7},"Annamaria Kausz, MD MS","2018-01-04","2020-05-25T16:35:25.157","2020-05-26T17:10:42.972","NCT03391804"]
["5ecbf3cc307e3d1b1f8d9c49","NCT03391804","2018-06-12","Allena","ALNA","Recruiting","Study of ALLN-177 in Patients Aged 12 Years or Older With Enteric or Primary Hyperoxaluria and Hyperoxalemia","Alln-177",null,"Yes","['Alln-177']","Unknown",null,"Phase 2",1,20,"Anticipated","2018-06-01","2019-06-01",{"$nulls":5},"Evaluate the efficacy and safety of ALLN-177 in reducing plasma and urinary oxalate levels in adult and pediatric patients with enteric hyperoxaluria and hyperoxalemia or primary hyperoxaluria","Phase 2, multi-center, open label, single arm study to evaluate the effect and safety of ALLN-177 in adult and pediatric patients aged 12 and older with enteric hyperoxaluria and hyperoxalemia or primary hyperoxaluria .\n\nApproximately 15-20 evaluable subjects are planned to be enrolled in the study. Eligible subjects will administer ALLN-177 with each meal/snack 5 times per day for 12 consecutive weeks.","Pilot Study of ALLN-177 in Adult and Pediatric Subjects Aged 12 Years or Older With Enteric or Primary Hyperoxaluria and Hyperoxalemia","ALLN-177-206","Enteric Hyperoxaluria\nPrimary Hyperoxaluria\nHyperoxalemia","Hyperoxaluria|Hyperoxaluria, Primary","Urologic Diseases","Reproductive and Urogenital","Experimental","ALLN-177","ALLN-177 7,500 units (2 capsules)","Drug","ALLN-177","ALLN-177 7,500 units (2 capsules) with each meal/snack by mouth 5 times per day for 12 weeks","Oxalate decarboxylase","ALLN-177","\n\n 1. Signed a informed consent form or an assent\n 2. Aged 12 or older with body weight â‰¥ 35kg\n 3. History of primary hyperoxaluria or enteric hyperoxaluria associated with a known underlying enteric disorder associated with malabsorption (e.g., bariatric surgery, Crohn's disease, short bowel syndrome, or other malabsorption syndrome)\n 4. Urinary oxalate â‰¥ 40mg/24h (normalized for body surface area in children) at Screening in patients with eGFR >15 mL/min/1.73m2\n 5. In patients with enteric hyperoxaluria, eGFR < 45mL/min/1.73m2 at Screening\n 6. In patients with enteric hyperoxaluria, plasma oxalate > 5Âµmol/L at Screening\n 7. Patients on dialysis, must be stable for greater than 3 months\n\n","\n\n1. Unable or unwilling to discontinue Vitamin C supplementation","EGFR","epidermal growth factor receptor","Protein","Ovary, Breast, Lung","Actual","2018-01-05","Actual","Anticipated","2019-12-01","Anticipated","2018-06-01","2018-01-02","2018-01-04","2018-06-08","No","Oxalate\nKidney Stones\noxalate nephropathy\nsystemic oxalosis","Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","12 Years",null,"All",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":17},"2017-003547-38","EudraCT Number","Change in plasma oxalate","Efficacy will be assessed based on change from baseline in plasma oxalate","on 12 weeks of treatment","Change in 24-hr urinary oxalate excretion","Efficacy will be assessed based on change from baseline in 24-hr urinary oxalate excretion","on 12 weeks of treatment","clinical206@allenapharma.com","Allena Communication Center","617-467-4577","Little Rock, Arkansas, United States, 72212|New Haven, Connecticut, United States, 06519","Arkansas|Connecticut","United States","Applied Research Center Of Arkansas|Yale University School Of Medicine",{"$nulls":3},"Annamaria Kausz, MD MS","2018-06-08","2020-05-25T16:35:24.728","2020-05-26T17:10:42.972","NCT03391804"]
["5ecbf3cce2561b1b11905cb4","NCT03391804","2018-08-13","Allena","ALNA","Recruiting","Study of ALLN-177 in Patients Aged 12 Years or Older With Enteric or Primary Hyperoxaluria and Hyperoxalemia","Alln-177",null,"Yes","['Alln-177']","Unknown",null,"Phase 2",1,20,"Anticipated","2018-07-17","2019-06-01",{"$nulls":5},"Evaluate the efficacy and safety of ALLN-177 in reducing plasma and urinary oxalate levels in adult and pediatric patients with enteric hyperoxaluria and hyperoxalemia or primary hyperoxaluria","Phase 2, multi-center, open label, single arm study to evaluate the effect and safety of ALLN-177 in adult and pediatric patients aged 12 and older with enteric hyperoxaluria and hyperoxalemia or primary hyperoxaluria .\n\nApproximately 15-20 evaluable subjects are planned to be enrolled in the study. Eligible subjects will administer ALLN-177 with each meal/snack 5 times per day for 12 consecutive weeks.","Pilot Study of ALLN-177 in Adult and Pediatric Subjects Aged 12 Years or Older With Enteric or Primary Hyperoxaluria and Hyperoxalemia","ALLN-177-206","Enteric Hyperoxaluria\nPrimary Hyperoxaluria\nHyperoxalemia","Hyperoxaluria|Hyperoxaluria, Primary","Urologic Diseases","Reproductive and Urogenital","Experimental","ALLN-177","ALLN-177 7,500 units (2 capsules)","Drug","ALLN-177","ALLN-177 7,500 units (2 capsules) with each meal/snack by mouth 5 times per day for 12 weeks","Oxalate decarboxylase","ALLN-177","\n\n 1. Signed a informed consent form or an assent\n 2. Aged 12 or older with body weight â‰¥ 35kg\n 3. History of primary hyperoxaluria or enteric hyperoxaluria associated with a known underlying enteric disorder associated with malabsorption (e.g., bariatric surgery, Crohn's disease, short bowel syndrome, or other malabsorption syndrome)\n 4. Urinary oxalate â‰¥ 40mg/24h (normalized for body surface area in children) at Screening in patients with eGFR >15 mL/min/1.73m2\n 5. In patients with enteric hyperoxaluria, eGFR < 45mL/min/1.73m2 at Screening\n 6. In patients with enteric hyperoxaluria, plasma oxalate > 5Âµmol/L at Screening\n 7. Patients on dialysis, must be stable for greater than 3 months\n\n","\n\n1. Unable or unwilling to discontinue Vitamin C supplementation","EGFR","epidermal growth factor receptor","Protein","Ovary, Breast, Lung","Actual","2018-01-05","Actual","Anticipated","2019-12-01","Anticipated","2018-08-01","2018-01-02","2018-01-04","2018-08-09","No","Oxalate\nKidney Stones\noxalate nephropathy\nsystemic oxalosis","Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","12 Years",null,"All",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":17},"2017-003547-38","EudraCT Number","Change in plasma oxalate","Efficacy will be assessed based on change from baseline in plasma oxalate","on 12 weeks of treatment","Change in 24-hr urinary oxalate excretion","Efficacy will be assessed based on change from baseline in 24-hr urinary oxalate excretion","on 12 weeks of treatment","clinical206@allenapharma.com","Allena Communication Center","617-467-4577","Little Rock, Arkansas, United States, 72212|New Haven, Connecticut, United States, 06519|Rochester, Minnesota, United States, 55905","Arkansas|Connecticut|Minnesota","United States","Applied Research Center Of Arkansas|Yale University School Of Medicine|Mayo Clinic",{"$nulls":3},"Annamaria Kausz, MD MS","2018-08-09","2020-05-25T16:35:24.531","2020-05-26T17:10:42.972","NCT03391804"]
["5ecbf3cc11702c1b1b9169cc","NCT03391804","2018-09-12","Allena","ALNA","Recruiting","Study of ALLN-177 in Patients Aged 12 Years or Older With Enteric or Primary Hyperoxaluria and Hyperoxalemia","Alln-177",null,"Yes","['Alln-177']","Unknown",null,"Phase 2",1,20,"Anticipated","2018-07-17","2019-06-01",{"$nulls":5},"Evaluate the efficacy and safety of ALLN-177 in reducing plasma and urinary oxalate levels in adult and pediatric patients with enteric hyperoxaluria and hyperoxalemia or primary hyperoxaluria","Phase 2, multi-center, open label, single arm study to evaluate the effect and safety of ALLN-177 in adult and pediatric patients aged 12 and older with enteric hyperoxaluria and hyperoxalemia or primary hyperoxaluria .\n\nApproximately 15-20 evaluable subjects are planned to be enrolled in the study. Eligible subjects will administer ALLN-177 with each meal/snack 5 times per day for 12 consecutive weeks.","Pilot Study of ALLN-177 in Adult and Pediatric Subjects Aged 12 Years or Older With Enteric or Primary Hyperoxaluria and Hyperoxalemia","ALLN-177-206","Enteric Hyperoxaluria\nPrimary Hyperoxaluria\nHyperoxalemia","Hyperoxaluria|Hyperoxaluria, Primary","Urologic Diseases","Reproductive and Urogenital","Experimental","ALLN-177","ALLN-177 7,500 units (2 capsules)","Drug","ALLN-177","ALLN-177 7,500 units (2 capsules) with each meal/snack by mouth 5 times per day for 12 weeks","Oxalate decarboxylase","ALLN-177","\n\n 1. Signed a informed consent form or an assent\n 2. Aged 12 or older with body weight â‰¥ 35kg\n 3. History of primary hyperoxaluria or enteric hyperoxaluria associated with a known underlying enteric disorder associated with malabsorption (e.g., bariatric surgery, Crohn's disease, short bowel syndrome, or other malabsorption syndrome)\n 4. Urinary oxalate â‰¥ 40mg/24h (normalized for body surface area in children) at Screening in patients with eGFR >15 mL/min/1.73m2\n 5. In patients with enteric hyperoxaluria, eGFR < 45mL/min/1.73m2 at Screening\n 6. In patients with enteric hyperoxaluria, plasma oxalate > 5Âµmol/L at Screening\n 7. Patients on dialysis, must be stable for greater than 3 months\n\n","\n\n1. Unable or unwilling to discontinue Vitamin C supplementation","EGFR","epidermal growth factor receptor","Protein","Ovary, Breast, Lung","Actual","2018-01-05","Actual","Anticipated","2019-12-01","Anticipated","2018-09-01","2018-01-02","2018-01-04","2018-09-11","No","Oxalate\nKidney Stones\noxalate nephropathy\nsystemic oxalosis","Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","12 Years",null,"All",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":17},"2017-003547-38","EudraCT Number","Change in plasma oxalate","Efficacy will be assessed based on change from baseline in plasma oxalate","on 12 weeks of treatment","Change in 24-hr urinary oxalate excretion","Efficacy will be assessed based on change from baseline in 24-hr urinary oxalate excretion","on 12 weeks of treatment","clinical206@allenapharma.com","Allena Communication Center","617-467-4577 Ext. 397","Little Rock, Arkansas, United States, 72212|New Haven, Connecticut, United States, 06519|Rochester, Minnesota, United States, 55905","Arkansas|Connecticut|Minnesota","United States","Applied Research Center Of Arkansas|Yale University School Of Medicine|Mayo Clinic",{"$nulls":3},"Annamaria Kausz, MD MS","2018-09-11","2020-05-25T16:35:24.730","2020-05-26T17:10:42.972","NCT03391804"]
["5ecbf3cdfeab101b155307e9","NCT03391804","2019-01-09","Allena","ALNA","Recruiting","Study of ALLN-177 in Patients Aged 12 Years or Older With Enteric or Primary Hyperoxaluria and Hyperoxalemia","Alln-177",null,"Yes","['Alln-177']","Unknown",null,"Phase 2",1,20,"Anticipated","2018-07-17","2019-06-01",{"$nulls":5},"Evaluate the efficacy and safety of ALLN-177 in reducing plasma and urinary oxalate levels in adult and pediatric patients with enteric hyperoxaluria and hyperoxalemia or primary hyperoxaluria","Phase 2, multi-center, open label, single arm study to evaluate the effect and safety of ALLN-177 in adult and pediatric patients aged 12 and older with enteric hyperoxaluria and hyperoxalemia or primary hyperoxaluria .\n\nApproximately 15-20 evaluable subjects are planned to be enrolled in the study. Eligible subjects will administer ALLN-177 with each meal/snack 5 times per day for 12 consecutive weeks.","Pilot Study of ALLN-177 in Adult and Pediatric Subjects Aged 12 Years or Older With Enteric or Primary Hyperoxaluria and Hyperoxalemia","ALLN-177-206","Enteric Hyperoxaluria\nPrimary Hyperoxaluria\nHyperoxalemia","Hyperoxaluria|Hyperoxaluria, Primary","Urologic Diseases","Reproductive and Urogenital","Experimental","ALLN-177","ALLN-177 7,500 units (2 capsules)","Drug","ALLN-177","ALLN-177 7,500 units (2 capsules) with each meal/snack by mouth 5 times per day for 12 weeks","Oxalate decarboxylase","ALLN-177","\n\n 1. Signed a informed consent form or an assent\n 2. Aged 12 or older with body weight â‰¥ 35kg\n 3. History of primary hyperoxaluria or enteric hyperoxaluria associated with a known underlying enteric disorder associated with malabsorption (e.g., bariatric surgery, Crohn's disease, short bowel syndrome, or other malabsorption syndrome)\n 4. Urinary oxalate â‰¥ 40mg/24h (normalized for body surface area in children) at Screening in patients with eGFR >15 mL/min/1.73m2\n 5. In patients with enteric hyperoxaluria, eGFR < 45mL/min/1.73m2 at Screening\n 6. In patients with enteric hyperoxaluria, plasma oxalate > 5Âµmol/L at Screening\n 7. Patients on dialysis, must be stable for greater than 3 months\n\n","\n\n1. Unable or unwilling to discontinue Vitamin C supplementation","EGFR","epidermal growth factor receptor","Protein","Ovary, Breast, Lung","Actual","2018-01-05","Actual","Anticipated","2019-12-01","Anticipated","2019-01-01","2018-01-02","2018-01-04","2019-01-08","No","Oxalate\nKidney Stones\noxalate nephropathy\nsystemic oxalosis","Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","12 Years",null,"All",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":17},"2017-003547-38","EudraCT Number","Change in plasma oxalate","Efficacy will be assessed based on change from baseline in plasma oxalate","on 12 weeks of treatment","Change in 24-hr urinary oxalate excretion","Efficacy will be assessed based on change from baseline in 24-hr urinary oxalate excretion","on 12 weeks of treatment","clinical206@allenapharma.com","Allena Communication Center","617-467-4577 Ext. 397","Berlin, Germany, 10117|Southampton, Hampshire, United Kingdom, So16 6Yd|Preston, Lancashire, United Kingdom, Pr2 9Ht|Newcastle, United Kingdom, Ne7 7 Dn|Scottsdale, Arizona, United States, 85259|Little Rock, Arkansas, United States, 72212|New Haven, Connecticut, United States, 06519|Rochester, Minnesota, United States, 55905","Arizona|Arkansas|Connecticut|Minnesota","Germany|United Kingdom|United States","Charite Campus Berlin-Mitte, Medizinische Klinik Mit Schwepunkt Nephrologie Und Internistische Intensivmedizin|, Hampshire Wellcome Trust Clinical Research Facility|, Lancashire Royal Preston Hospital|Freeman Hospital|Mayo Clinic|Applied Research Center Of Arkansas|Yale University School Of Medicine",{"$nulls":3},"Annamaria Kausz, MD MS","2019-01-08","2020-05-25T16:35:25.109","2020-05-26T17:10:42.972","NCT03391804"]
["5ecbf3cdfe30261b1a0481b9","NCT03391804","2019-02-21","Allena","ALNA","Recruiting","Study of ALLN-177 in Patients Aged 12 Years or Older With Enteric or Primary Hyperoxaluria and Hyperoxalemia","Alln-177",null,"Yes","['Alln-177']","Unknown",null,"Phase 2",1,20,"Anticipated","2018-07-17","2019-06-01",{"$nulls":5},"Evaluate the efficacy and safety of ALLN-177 in reducing plasma and urinary oxalate levels in adult and pediatric patients with enteric hyperoxaluria and hyperoxalemia or primary hyperoxaluria","Phase 2, multi-center, open label, single arm study to evaluate the effect and safety of ALLN-177 in adult and pediatric patients aged 12 and older with enteric hyperoxaluria and hyperoxalemia or primary hyperoxaluria .\n\nApproximately 15-20 evaluable subjects are planned to be enrolled in the study. Eligible subjects will administer ALLN-177 with each meal/snack 5 times per day for 12 consecutive weeks.","Pilot Study of ALLN-177 in Adult and Pediatric Subjects Aged 12 Years or Older With Enteric or Primary Hyperoxaluria and Hyperoxalemia","ALLN-177-206","Enteric Hyperoxaluria\nPrimary Hyperoxaluria\nHyperoxalemia","Hyperoxaluria|Hyperoxaluria, Primary","Urologic Diseases","Reproductive and Urogenital","Experimental","ALLN-177","ALLN-177 7,500 units (2 capsules)","Drug","ALLN-177","ALLN-177 7,500 units (2 capsules) with each meal/snack by mouth 5 times per day for 12 weeks","Oxalate decarboxylase","ALLN-177","\n\n 1. Signed a informed consent form or an assent\n 2. Aged 12 or older with body weight â‰¥ 35kg\n 3. History of primary hyperoxaluria or enteric hyperoxaluria associated with a known underlying enteric disorder associated with malabsorption (e.g., bariatric surgery, Crohn's disease, short bowel syndrome, or other malabsorption syndrome)\n 4. Urinary oxalate â‰¥ 40mg/24h (normalized for body surface area in children) at Screening in patients with eGFR >15 mL/min/1.73m2\n 5. In patients with enteric hyperoxaluria, eGFR < 45mL/min/1.73m2 at Screening\n 6. In patients with enteric hyperoxaluria, plasma oxalate > 5Âµmol/L at Screening\n 7. Patients on dialysis, must be stable for greater than 3 months\n\n","\n\n1. Unable or unwilling to discontinue Vitamin C supplementation","EGFR","epidermal growth factor receptor","Protein","Ovary, Breast, Lung","Actual","2018-01-05","Actual","Anticipated","2019-12-01","Anticipated","2019-01-01","2018-01-02","2018-01-04","2019-02-19","No","Oxalate\nKidney Stones\noxalate nephropathy\nsystemic oxalosis","Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","12 Years",null,"All",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":17},"2017-003547-38","EudraCT Number","Change in plasma oxalate","Efficacy will be assessed based on change from baseline in plasma oxalate","on 12 weeks of treatment","Change in 24-hr urinary oxalate excretion","Efficacy will be assessed based on change from baseline in 24-hr urinary oxalate excretion","on 12 weeks of treatment","clinical206@allenapharma.com","Allena Communication Center","617-467-4577 Ext. 397","Berlin, Germany, 10117|Southampton, Hampshire, United Kingdom, So16 6Yd|Preston, Lancashire, United Kingdom, Pr2 9Ht|Leeds, United Kingdom, Ls1 3Ex Freeman HospitalNewcastle, United Kingdom, Ne7 7 Dn|Scottsdale, Arizona, United States, 85259|Little Rock, Arkansas, United States, 72212|New Haven, Connecticut, United States, 06519|Rochester, Minnesota, United States, 55905","Arizona|Arkansas|Connecticut|Minnesota","Germany|United Kingdom|United States","Charite Campus Berlin-Mitte, Medizinische Klinik Mit Schwepunkt Nephrologie Und Internistische Intensivmedizin|, Hampshire Wellcome Trust Clinical Research Facility|, Lancashire Royal Preston Hospital|Leeds General Infirmary|Mayo Clinic|Applied Research Center Of Arkansas|Yale University School Of Medicine",{"$nulls":3},"Annamaria Kausz, MD MS","2019-02-19","2020-05-25T16:35:25.044","2020-05-26T17:10:42.972","NCT03391804"]
["5ecbf3cdfe30261b1a0481ba","NCT03391804","2019-07-10","Allena","ALNA","Recruiting","Study of ALLN-177 in Patients Aged 12 Years or Older With Enteric or Primary Hyperoxaluria and Hyperoxalemia","Alln-177",null,"Yes","['Alln-177']","Unknown",null,"Phase 2",1,20,"Anticipated","2018-07-17","2019-12-01",{"$nulls":5},"Evaluate the efficacy and safety of ALLN-177 in reducing plasma and urinary oxalate levels in adult and pediatric patients with enteric hyperoxaluria and hyperoxalemia or primary hyperoxaluria","Phase 2, multi-center, open label, single arm study to evaluate the effect and safety of ALLN-177 in adult and pediatric patients aged 12 and older with enteric hyperoxaluria and hyperoxalemia or primary hyperoxaluria .\n\nApproximately 15-20 evaluable subjects are planned to be enrolled in the study. Eligible subjects will administer ALLN-177 with each meal/snack 5 times per day for 12 consecutive weeks.","Pilot Study of ALLN-177 in Adult and Pediatric Subjects Aged 12 Years or Older With Enteric or Primary Hyperoxaluria and Hyperoxalemia","ALLN-177-206","Enteric Hyperoxaluria\nPrimary Hyperoxaluria\nHyperoxalemia","Hyperoxaluria|Hyperoxaluria, Primary","Urologic Diseases","Reproductive and Urogenital","Experimental","ALLN-177","ALLN-177 7,500 units (2 capsules)","Drug","ALLN-177","ALLN-177 7,500 units (2 capsules) with each meal/snack by mouth 5 times per day for 12 weeks","Oxalate decarboxylase","ALLN-177","\n\n 1. Signed a informed consent form or an assent\n 2. Aged 12 or older with body weight â‰¥ 35kg\n 3. History of primary hyperoxaluria or enteric hyperoxaluria associated with a known underlying enteric disorder associated with malabsorption (e.g., bariatric surgery, Crohn's disease, short bowel syndrome, or other malabsorption syndrome)\n 4. Urinary oxalate â‰¥ 40mg/24h (normalized for body surface area in children) at Screening in patients with eGFR >15 mL/min/1.73m2\n 5. In patients with enteric hyperoxaluria, eGFR < 45mL/min/1.73m2 at Screening\n 6. In patients with enteric hyperoxaluria, plasma oxalate > 5Âµmol/L at Screening\n 7. Patients on dialysis, must be stable for greater than 3 months\n\n","\n\n1. Unable or unwilling to discontinue Vitamin C supplementation","EGFR","epidermal growth factor receptor","Protein","Ovary, Breast, Lung","Actual","2018-01-05","Actual","Anticipated","2020-02-01","Anticipated","2019-07-01","2018-01-02","2018-01-04","2019-07-08","No","Oxalate\nKidney Stones\noxalate nephropathy\nsystemic oxalosis","Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","12 Years",null,"All",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":17},"2017-003547-38","EudraCT Number","Change in plasma oxalate","Efficacy will be assessed based on change from baseline in plasma oxalate","on 12 weeks of treatment","Change in 24-hr urinary oxalate excretion","Efficacy will be assessed based on change from baseline in 24-hr urinary oxalate excretion","on 12 weeks of treatment","clinical206@allenapharma.com","Allena Communication Center","617-467-4577 Ext. 397","Berlin, Germany, 10117|Southampton, Hampshire, United Kingdom, So16 6Yd|Preston, Lancashire, United Kingdom, Pr2 9Ht|Leeds, United Kingdom, Ls1 3Ex Freeman HospitalNewcastle, United Kingdom, Ne7 7 Dn|Scottsdale, Arizona, United States, 85259|Little Rock, Arkansas, United States, 72212|New Haven, Connecticut, United States, 06519|Rochester, Minnesota, United States, 55905","Arizona|Arkansas|Connecticut|Minnesota","Germany|United Kingdom|United States","Charite Campus Berlin-Mitte, Medizinische Klinik Mit Schwepunkt Nephrologie Und Internistische Intensivmedizin|, Hampshire Wellcome Trust Clinical Research Facility|, Lancashire Royal Preston Hospital|Leeds General Infirmary|Mayo Clinic|Applied Research Center Of Arkansas|Yale University School Of Medicine",{"$nulls":3},"Annamaria Kausz, MD MS","2019-07-08","2020-05-25T16:35:25.267","2020-05-26T17:10:42.972","NCT03391804"]
["5ecbf3cde2561b1b11905cb5","NCT03391804","2020-02-27","Allena","ALNA","Completed","Study of ALLN-177 in Patients Aged 12 Years or Older With Enteric or Primary Hyperoxaluria and Hyperoxalemia","Alln-177",null,"Yes","['Alln-177']","Unknown",null,"Phase 2",1,15,"Actual","2018-07-17","2019-12-13",{"$nulls":5},"Evaluate the efficacy and safety of ALLN-177 in reducing plasma and urinary oxalate levels in adult and pediatric patients with enteric hyperoxaluria and hyperoxalemia or primary hyperoxaluria","Phase 2, multi-center, open label, single arm study to evaluate the effect and safety of ALLN-177 in adult and pediatric patients aged 12 and older with enteric hyperoxaluria and hyperoxalemia or primary hyperoxaluria .\n\nApproximately 15-20 evaluable subjects are planned to be enrolled in the study. Eligible subjects will administer ALLN-177 with each meal/snack 5 times per day for 12 consecutive weeks.","Pilot Study of ALLN-177 in Adult and Pediatric Subjects Aged 12 Years or Older With Enteric or Primary Hyperoxaluria and Hyperoxalemia","ALLN-177-206","Enteric Hyperoxaluria\nPrimary Hyperoxaluria\nHyperoxalemia","Hyperoxaluria|Hyperoxaluria, Primary","Urologic Diseases","Reproductive and Urogenital","Experimental","ALLN-177","ALLN-177 7,500 units (2 capsules)","Drug","ALLN-177","ALLN-177 7,500 units (2 capsules) with each meal/snack by mouth 5 times per day for 12 weeks","Oxalate decarboxylase","ALLN-177","\n\n 1. Signed a informed consent form or an assent\n 2. Aged 12 or older with body weight â‰¥ 35kg\n 3. History of primary hyperoxaluria or enteric hyperoxaluria associated with a known underlying enteric disorder associated with malabsorption (e.g., bariatric surgery, Crohn's disease, short bowel syndrome, or other malabsorption syndrome)\n 4. Urinary oxalate â‰¥ 40mg/24h (normalized for body surface area in children) at Screening in patients with eGFR >15 mL/min/1.73m2\n 5. In patients with enteric hyperoxaluria, eGFR < 45mL/min/1.73m2 at Screening\n 6. In patients with enteric hyperoxaluria, plasma oxalate > 5Âµmol/L at Screening\n 7. Patients on dialysis, must be stable for greater than 3 months\n\n","\n\n1. Unable or unwilling to discontinue Vitamin C supplementation","EGFR","epidermal growth factor receptor","Protein","Ovary, Breast, Lung","Actual","2018-01-05","Actual","Actual","2019-12-13","Actual","2020-02-01","2018-01-02","2018-01-04","2020-02-25","No","Oxalate\nKidney Stones\noxalate nephropathy\nsystemic oxalosis","Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","12 Years",null,"All",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":17},"2017-003547-38","EudraCT Number","Change in plasma oxalate","Efficacy will be assessed based on change from baseline in plasma oxalate","on 12 weeks of treatment","Change in 24-hr urinary oxalate excretion","Efficacy will be assessed based on change from baseline in 24-hr urinary oxalate excretion","on 12 weeks of treatment",{"$nulls":3},"Berlin, Germany, 10117|Southampton, Hampshire, United Kingdom, So16 6Yd|Preston, Lancashire, United Kingdom, Pr2 9Ht|Leeds, United Kingdom, Ls1 3Ex Freeman HospitalNewcastle, United Kingdom, Ne7 7 Dn|Scottsdale, Arizona, United States, 85259|Little Rock, Arkansas, United States, 72212|New Haven, Connecticut, United States, 06519|Rochester, Minnesota, United States, 55905","Arizona|Arkansas|Connecticut|Minnesota","Germany|United Kingdom|United States","Charite Campus Berlin-Mitte, Medizinische Klinik Mit Schwepunkt Nephrologie Und Internistische Intensivmedizin|, Hampshire Wellcome Trust Clinical Research Facility|, Lancashire Royal Preston Hospital|Leeds General Infirmary|Mayo Clinic|Applied Research Center Of Arkansas|Yale University School Of Medicine",{"$nulls":3},"Annamaria Kausz, MD MS","2020-02-25","2020-05-25T16:35:25.116","2020-05-26T17:10:42.972","NCT03391804"]
["5ecbf3cdfeab101b155307ea","NCT03391882","2018-01-05","Sunovion","SEPR","Not yet recruiting","A Study of an Investigational Drug to See How it Affects the People With Parkinson's Disease Complicated by Motor Fluctuations (\"OFF\" Episodes) Compared to an Approved Drug Used to Treat People With Parkinson's Disease Complicated by Motor Fluctuations (\"OFF\" Episodes)","Apomorphine","DS Agonist","No",null,"No",null,"Phase 3",2,85,"Anticipated","2018-01-03","2019-05-24",{"$nulls":5},"A study of an investigational drug to see how it affects the people with Parkinson's Disease complicated by motor fluctuations (\"OFF\" Episodes) compared to an approved drug used to treat people with Parkinson's Disease complicated by motor fluctuations (\"OFF\" Episodes)","An Open-Label, Randomized, Crossover Trial utilizing a Single-Blinded Rater to evaluate sublingual administered APL-130277 (apomorphine) compared to subcutaneously administered APO-goÂ® (apomorphine) in Levodopa Responsive Subjects with Parkinson's Disease complicated by motor fluctuations.\n\nThis is a two part study. The first part consists of an open-label, crossover titration phase where subjects will be randomly assigned to APL-130277 or APO-goÂ® and titrated to the dose that turns them from the practically defined \"OFF\" state to the full \"ON\" state. They will then be crossed over to the other drug and similarly titrated to the dose that provides a full \"ON\" state.\n\nThe second part of the study consists of open-label repeated doses of APL-130277 or APO-goÂ® (at the dose determined in the first part) for 28 days, and then cross-over to the other drug for repeat doses for 28 days.","An Open-Label, Randomized, Crossover Trial Utilizing a Single-Blinded Rater to Evaluate APL-130277 Compared to Subcutaneous Apomorphine in Levodopa Responsive Subjects With Parkinson's Disease Complicated by Motor Fluctuations","CTH-302","Motor OFF Episodes Associated With Parkinson's Disease","Parkinson Disease","Central Nervous System Diseases","Central Nervous System","Experimental|Active Comparator","APL-130277|APO-goÂ®:","APL-130277: Part 1- determine the dose; Part 2- 28-day repeat dosing at the dose determined in Part 1|APO-goÂ®: Part 1- determine the dose; Part 2- 28-day repeat dosing at the dose determined in Part 1","Drug","APL-130277|APO-go&#xAE;","APL-130277: Part 1- determine the dose; Part 2- 28-day repeat dosing at the dose determined in Part 1|: APO-goÂ® Part 1- determine the dose; Part 2- 28-day repeat dosing at the dose determined in Part 1","no other names|apomorphine","APL-130277|APO-goÂ®:","\n\n * 1. Male or female â‰¥ 18 years of age.2. Clinical diagnosis of Idiopathic PD, consistent with UK Brain Bank Criteria.\n   \n   3. Clinically meaningful response to L-Dopa as determined by the Investigator.\n   \n   4. Receiving stable doses of L-Dopa/carbidopa and/or L-Dopa/benserazide and/or L-Dopa/ carbidopa/ entacapone (immediate or chronic release) administered at least 4 times per day OR Rytaryâ„¢ administered at least 3 times per day, and on stable doses for at least4 weeks before the initial Screening Visit (SV1). Adjunctive PD medication regimens are permitted but must be maintained at a stable does for at least 4 weeks prior to SV1 with the exception of monoamine oxidase B MAO-B) inhibitors, which must be maintained at a stable level for at least 8 weeks prior to SV1.\n   \n   5. No planned medication change(s) or surgical intervention anticipated during the course of study.\n   \n   6. Subjects must experience at least one well defined \"OFF\" episode per day with a total daily \"OFF\" time duration of > 2 hours during the waking day, based on judgment of physician and subject self-assessment.\n   \n   7. Subject must have predictable morning \"OFF\" periods.\n   \n   8. Subject and where appropriate, caregiver, must be trained in completing the home dosing diary and able to recognize \"ON\" and \"OFF\" states.\n   \n   9. Stage III or less on the modified Hoehn and Yahr scale in the \"ON\" state.\n   \n   10. Mini-Mental State Examination (MMSE) score > 25.\n   \n   11. Female subject of childbearing potential and male subject with female partner of childbearing potential must agree to use an effective and medically acceptable form of birth control throughout the study period. Note: Continued use of an effective and medically acceptable form of birth control is recommended through 30 days after study completion.\n   \n   12. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study related procedures to complete the study.\n   \n   13. Able to understand the consent form, and to provide written informed consent.\n   \n   14. Must be approved as a satisfactory candidate by the Enrollment Adjudication Committee (EAC).\n   \n   \n\n","\n\n * 1.Atypical or secondary parkinsonism.2. Previous treatment with any of the following: a neurosurgical procedure for PD; continuous subcutaneous (s.c.) apomorphine infusion; subcutaneous (s.c.) apomorphine injection; Duodopa/Duopa; or APL-130277.\n   \n   3. Contraindications to domperidone, subcutaneous apomorphine, or hypersensitivity to apomorphine, hydrochloride or any of the ingredients of subcutaneous apomorphine (notably sodium metabisulfite).\n   \n   4. Female who is pregnant or lactating.\n   \n   5. Participation in a clinical trial within 30 days prior to SV1.\n   \n   6. Receipt of any investigational (ie, unapproved) medication within 30 days prior to SV1.\n   \n   7. Currently taking selective 5HT3 antagonists (ie, ondansetron, granisetron, dolasetron, palonosetron, alosetron), dopamine antagonists (excluding quetiapine or clozapine) or dopamine depleting agents. Subjects receiving anti-depressants must be on a stable daily dose for at least 8 weeks before SV1.\n   \n   8. The subject has a current diagnosis or history of substance abuse (excluding cannabinoids, nicotine, and caffeine) or alcohol abuse (in the opinion of the investigator) < 6 months prior to SV1.\n   \n   9. Subject has a history of malignancy within 5 years prior to SV1, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer. Pituitary tumors of any duration are excluded.\n   \n   10. Subject has a clinically significant abnormality on screening evaluation including physical examination, vital signs, ECG, or laboratory tests that the Investigator considers to be inappropriate to allow participation in the study.\n   \n   11. Subject has screening laboratory test results of: blood urea nitrogen (BUN) value â‰¥ 1.5 times the upper limit of normal (ULN) for the reference range; serum creatinine > 1.5 times the ULN for the reference range; or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value value â‰¥ 2 times the ULN for the reference laboratory.\n   \n   12. Subject is on injectable medication for the treatment of Type 2 diabetes. A subject with\n   \n   \n\nType 2 diabetes is eligible for study inclusion if considered clinically stable, which is defined as:\n\n * Random (non-fasting) screening glucose is < 200 mg/dl (11.1 mmol/L); andâ€¢ HbA1c â‰¤ 6.5%; and\n * If a subject is currently being treated with oral anti-diabetic medication(s), the dose must have been stable for at least 4 weeks prior to screening. Such medication may be adjusted or discontinued during the study, as clinically indicated.\n\nNote: If the subject's random (non-fasting) screening glucose is â‰¥ 200 mg/dL (11.1 mmol/L), glucose must be retested in a fasted state. If the retested fasted value is â‰¥ 126 mg/dL (7.0 mmol/L), the subject will be excluded.\n\n13. The subject's screening ECG at SV1 or SV2 shows a corrected QT interval using Fridericia's formula (QTcF) of â‰¥ 450 msec for male subjects or â‰¥ 470 msec for female subjects. Eligibility will be based on the core laboratory ECG interpretation report.\n\n14. Subject has a positive screening laboratory test result for human immunodeficiency virus (HIV).\n\n15. Subject has a positive screening laboratory test result for hepatitis B surface antigen or hepatitis C antibodies and has liver function test results at screening above the ULN for the reference laboratory.\n\n16. Subject has major psychiatric disorder, including but not limited to in the last 12 months: bipolar disorder, psychosis (including hallucinations), major depressive episode, or any disorder that, in the opinion of the Investigator, requires new or ongoing treatment that would make study participation unsafe or make treatment compliance difficult.\n\n17. Subject has Parkinson's disease psychosis (PDP) that precludes providing informed consent or would interfere with participation in the study. Symptoms of PDP commonly include visual hallucinations, delusions (paranoia) and illusions (misperception of objects).\n\n18. History of clinically significant impulse control disorder(s).\n\n19. Orthostatic hypotension (defined clinically as requiring medication).\n\n20. Dementia that precludes providing informed consent or would interfere with participation in the study.\n\n21. Current suicidal ideation within one year prior to Screening Visit 2 (SV2) as evidenced by answering \"yes\" to Questions 4 or 5 on the suicidal ideation portion of the Columbia-Suicide Severity Rating Scale (C-SSRS) or attempted suicide within the last 5 years.\n\n22. Presence of canker or mouth sores in the 30 days prior to SV1, or other clinically significant oral pathology in the opinion of the Investigator. The Investigator should follow-up with an appropriate specialist on any finding, if indicated before enrolling a subject into the study.","MAOB","monoamine oxidase B","Gene","Prostate","Actual","2018-01-05","Actual","Anticipated","2019-05-24","Anticipated","2018-01-01","2018-01-02","2018-01-02","2018-01-02","No","Parkinson's Disease\n\"Off\" Episodes\nmotor fluctuations associated with Parkinson's Disease","Interventional","Treatment","Crossover Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":4},"Yes",{"$nulls":12},"2016-003456-70","EudraCT Number","Percentage of subjects preferring sublingual APL-130277 (apomorphine) compared to percentage of subjects preferring subcutaneous APO-go (apomorphine).","Over the entire study (approx. 85 days).",null,"Mean change from pre-dose in MDS-UPDRS Part III Motor Examination score at 90 minutes post-dose.|MDS-UPDRS Part II Motor Aspects of Experiences of Daily Living. mean change from Screening in the MDS-UPDRS Part II sum score|Patient Global Impression of Improvement (PGI):The percentage of subjects improved (ie, very much improved, much improved or minimally improved)|Percentage of subjects without a worsening of troublesome dyskinesia (dyskinesia in the last month is less than usual)|Parkinson's Disease Questionnaire-39 (PDQ-39) mean change from Screening in Summary Index score|Percentage of subjects with investigator confirmed Full \"ON\" within 30 minutes post-dose","Part B Visit 3 and 6 (after 4 weeks of dosing in each crossover period of PART B)|Part B V3 and 6 (after 4 weeks of dosing in each crossover period of PART B)",null,"clinicaltrialsdisclousre@sunovion.com","CNS Medical Director","1-866-503-6351",{"$nulls":7},"CNS Medical Director","2018-01-02","2020-05-25T16:35:25.550","2020-05-26T17:10:42.972","NCT03391882"]
["5ecbf3cd307e3d1b1f8d9c4a","NCT03391882","2018-01-18","Sunovion","SEPR","Not yet recruiting","A Study of an Investigational Drug to See How it Affects the People With Parkinson's Disease Complicated by Motor Fluctuations (\"OFF\" Episodes) Compared to an Approved Drug Used to Treat People With Parkinson's Disease Complicated by Motor Fluctuations (\"OFF\" Episodes)","Apomorphine","DS Agonist","No",null,"No",null,"Phase 3",2,85,"Anticipated","2018-01-22","2019-05-24",{"$nulls":5},"A study of an investigational drug to see how it affects the people with Parkinson's Disease complicated by motor fluctuations (\"OFF\" Episodes) compared to an approved drug used to treat people with Parkinson's Disease complicated by motor fluctuations (\"OFF\" Episodes)","An Open-Label, Randomized, Crossover Trial utilizing a Single-Blinded Rater to evaluate sublingual administered APL-130277 (apomorphine) compared to subcutaneously administered APO-goÂ® (apomorphine) in Levodopa Responsive Subjects with Parkinson's Disease complicated by motor fluctuations.\n\nThis is a two part study. The first part consists of an open-label, crossover titration phase where subjects will be randomly assigned to APL-130277 or APO-goÂ® and titrated to the dose that turns them from the practically defined \"OFF\" state to the full \"ON\" state. They will then be crossed over to the other drug and similarly titrated to the dose that provides a full \"ON\" state.\n\nThe second part of the study consists of open-label repeated doses of APL-130277 or APO-goÂ® (at the dose determined in the first part) for 28 days, and then cross-over to the other drug for repeat doses for 28 days.","An Open-Label, Randomized, Crossover Trial Utilizing a Single-Blinded Rater to Evaluate APL-130277 Compared to Subcutaneous Apomorphine in Levodopa Responsive Subjects With Parkinson's Disease Complicated by Motor Fluctuations","CTH-302","Motor OFF Episodes Associated With Parkinson's Disease","Parkinson Disease","Central Nervous System Diseases","Central Nervous System","Experimental|Active Comparator","APL-130277|APO-goÂ®:","APL-130277: Part 1- determine the dose; Part 2- 28-day repeat dosing at the dose determined in Part 1|APO-goÂ®: Part 1- determine the dose; Part 2- 28-day repeat dosing at the dose determined in Part 1","Drug","APL-130277|APO-go&#xAE;","APL-130277: Part 1- determine the dose; Part 2- 28-day repeat dosing at the dose determined in Part 1|: APO-goÂ® Part 1- determine the dose; Part 2- 28-day repeat dosing at the dose determined in Part 1","no other names|apomorphine","APL-130277|APO-goÂ®:","\n\n * 1. Male or female â‰¥ 18 years of age.2. Clinical diagnosis of Idiopathic PD, consistent with UK Brain Bank Criteria.\n   \n   3. Clinically meaningful response to L-Dopa as determined by the Investigator.\n   \n   4. Receiving stable doses of L-Dopa/carbidopa and/or L-Dopa/benserazide and/or L-Dopa/ carbidopa/ entacapone (immediate or chronic release) administered at least 4 times per day OR Rytaryâ„¢ administered at least 3 times per day, and on stable doses for at least4 weeks before the initial Screening Visit (SV1). Adjunctive PD medication regimens are permitted but must be maintained at a stable does for at least 4 weeks prior to SV1 with the exception of monoamine oxidase B MAO-B) inhibitors, which must be maintained at a stable level for at least 8 weeks prior to SV1.\n   \n   5. No planned medication change(s) or surgical intervention anticipated during the course of study.\n   \n   6. Subjects must experience at least one well defined \"OFF\" episode per day with a total daily \"OFF\" time duration of > 2 hours during the waking day, based on judgment of physician and subject self-assessment.\n   \n   7. Subject must have predictable morning \"OFF\" periods.\n   \n   8. Subject and where appropriate, caregiver, must be trained in completing the home dosing diary and able to recognize \"ON\" and \"OFF\" states.\n   \n   9. Stage III or less on the modified Hoehn and Yahr scale in the \"ON\" state.\n   \n   10. Mini-Mental State Examination (MMSE) score > 25.\n   \n   11. Female subject of childbearing potential and male subject with female partner of childbearing potential must agree to use an effective and medically acceptable form of birth control throughout the study period. Note: Continued use of an effective and medically acceptable form of birth control is recommended through 30 days after study completion.\n   \n   12. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study related procedures to complete the study.\n   \n   13. Able to understand the consent form, and to provide written informed consent.\n   \n   14. Must be approved as a satisfactory candidate by the Enrollment Adjudication Committee (EAC).\n   \n   \n\n","\n\n * 1.Atypical or secondary parkinsonism.2. Previous treatment with any of the following: a neurosurgical procedure for PD; continuous subcutaneous (s.c.) apomorphine infusion; subcutaneous (s.c.) apomorphine injection; Duodopa/Duopa; or APL-130277.\n   \n   3. Contraindications to domperidone, subcutaneous apomorphine, or hypersensitivity to apomorphine, hydrochloride or any of the ingredients of subcutaneous apomorphine (notably sodium metabisulfite).\n   \n   4. Female who is pregnant or lactating.\n   \n   5. Participation in a clinical trial within 30 days prior to SV1.\n   \n   6. Receipt of any investigational (ie, unapproved) medication within 30 days prior to SV1.\n   \n   7. Currently taking selective 5HT3 antagonists (ie, ondansetron, granisetron, dolasetron, palonosetron, alosetron), dopamine antagonists (excluding quetiapine or clozapine) or dopamine depleting agents. Subjects receiving anti-depressants must be on a stable daily dose for at least 8 weeks before SV1.\n   \n   8. The subject has a current diagnosis or history of substance abuse (excluding cannabinoids, nicotine, and caffeine) or alcohol abuse (in the opinion of the investigator) < 6 months prior to SV1.\n   \n   9. Subject has a history of malignancy within 5 years prior to SV1, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer. Pituitary tumors of any duration are excluded.\n   \n   10. Subject has a clinically significant abnormality on screening evaluation including physical examination, vital signs, ECG, or laboratory tests that the Investigator considers to be inappropriate to allow participation in the study.\n   \n   11. Subject has screening laboratory test results of: blood urea nitrogen (BUN) value â‰¥ 1.5 times the upper limit of normal (ULN) for the reference range; serum creatinine > 1.5 times the ULN for the reference range; or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value value â‰¥ 2 times the ULN for the reference laboratory.\n   \n   12. Subject is on injectable medication for the treatment of Type 2 diabetes. A subject with\n   \n   \n\nType 2 diabetes is eligible for study inclusion if considered clinically stable, which is defined as:\n\n * Random (non-fasting) screening glucose is < 200 mg/dl (11.1 mmol/L); andâ€¢ HbA1c â‰¤ 6.5%; and\n * If a subject is currently being treated with oral anti-diabetic medication(s), the dose must have been stable for at least 4 weeks prior to screening. Such medication may be adjusted or discontinued during the study, as clinically indicated.\n\nNote: If the subject's random (non-fasting) screening glucose is â‰¥ 200 mg/dL (11.1 mmol/L), glucose must be retested in a fasted state. If the retested fasted value is â‰¥ 126 mg/dL (7.0 mmol/L), the subject will be excluded.\n\n13. The subject's screening ECG at SV1 or SV2 shows a corrected QT interval using Fridericia's formula (QTcF) of â‰¥ 450 msec for male subjects or â‰¥ 470 msec for female subjects. Eligibility will be based on the core laboratory ECG interpretation report.\n\n14. Subject has a positive screening laboratory test result for human immunodeficiency virus (HIV).\n\n15. Subject has a positive screening laboratory test result for hepatitis B surface antigen or hepatitis C antibodies and has liver function test results at screening above the ULN for the reference laboratory.\n\n16. Subject has major psychiatric disorder, including but not limited to in the last 12 months: bipolar disorder, psychosis (including hallucinations), major depressive episode, or any disorder that, in the opinion of the Investigator, requires new or ongoing treatment that would make study participation unsafe or make treatment compliance difficult.\n\n17. Subject has Parkinson's disease psychosis (PDP) that precludes providing informed consent or would interfere with participation in the study. Symptoms of PDP commonly include visual hallucinations, delusions (paranoia) and illusions (misperception of objects).\n\n18. History of clinically significant impulse control disorder(s).\n\n19. Orthostatic hypotension (defined clinically as requiring medication).\n\n20. Dementia that precludes providing informed consent or would interfere with participation in the study.\n\n21. Current suicidal ideation within one year prior to Screening Visit 2 (SV2) as evidenced by answering \"yes\" to Questions 4 or 5 on the suicidal ideation portion of the Columbia-Suicide Severity Rating Scale (C-SSRS) or attempted suicide within the last 5 years.\n\n22. Presence of canker or mouth sores in the 30 days prior to SV1, or other clinically significant oral pathology in the opinion of the Investigator. The Investigator should follow-up with an appropriate specialist on any finding, if indicated before enrolling a subject into the study.","MAOB","monoamine oxidase B","Gene","Prostate","Actual","2018-01-05","Actual","Anticipated","2019-05-24","Anticipated","2018-01-01","2018-01-02","2018-01-02","2018-01-16","No","Parkinson's Disease\n\"Off\" Episodes\nmotor fluctuations associated with Parkinson's Disease","Interventional","Treatment","Crossover Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":4},"Yes",{"$nulls":12},"2016-003456-70","EudraCT Number","Percentage of subjects preferring sublingual APL-130277 (apomorphine) compared to percentage of subjects preferring subcutaneous APO-go (apomorphine).","Over the entire study (approx. 85 days).",null,"Mean change from pre-dose in MDS-UPDRS Part III Motor Examination score at 90 minutes post-dose.|MDS-UPDRS Part II Motor Aspects of Experiences of Daily Living. mean change from Screening in the MDS-UPDRS Part II sum score|Patient Global Impression of Improvement (PGI):The percentage of subjects improved (ie, very much improved, much improved or minimally improved)|Percentage of subjects without a worsening of troublesome dyskinesia (dyskinesia in the last month is less than usual)|Parkinson's Disease Questionnaire-39 (PDQ-39) mean change from Screening in Summary Index score|Percentage of subjects with investigator confirmed Full \"ON\" within 30 minutes post-dose","Part B Visit 3 and 6 (after 4 weeks of dosing in each crossover period of PART B)|Part B V3 and 6 (after 4 weeks of dosing in each crossover period of PART B)",null,"clinicaltrialsdisclousre@sunovion.com","CNS Medical Director","1-866-503-6351",{"$nulls":7},"CNS Medical Director","2018-01-16","2020-05-25T16:35:25.369","2020-05-26T17:10:42.972","NCT03391882"]
["5ecbf3cde2561b1b11905cb6","NCT03391882","2018-02-28","Sunovion","SEPR","Not yet recruiting","A Study of an Investigational Drug to See How it Affects the People With Parkinson's Disease Complicated by Motor Fluctuations (\"OFF\" Episodes) Compared to an Approved Drug Used to Treat People With Parkinson's Disease Complicated by Motor Fluctuations (\"OFF\" Episodes)","Apomorphine","DS Agonist","No",null,"No",null,"Phase 3",2,85,"Anticipated","2018-05-01","2019-05-24",{"$nulls":5},"A study of an investigational drug to see how it affects the people with Parkinson's Disease complicated by motor fluctuations (\"OFF\" Episodes) compared to an approved drug used to treat people with Parkinson's Disease complicated by motor fluctuations (\"OFF\" Episodes)","An Open-Label, Randomized, Crossover Trial utilizing a Single-Blinded Rater to evaluate sublingual administered APL-130277 (apomorphine) compared to subcutaneously administered APO-goÂ® (apomorphine) in Levodopa Responsive Subjects with Parkinson's Disease complicated by motor fluctuations.\n\nThis is a two part study. The first part consists of an open-label, crossover titration phase where subjects will be randomly assigned to APL-130277 or APO-goÂ® and titrated to the dose that turns them from the practically defined \"OFF\" state to the full \"ON\" state. They will then be crossed over to the other drug and similarly titrated to the dose that provides a full \"ON\" state.\n\nThe second part of the study consists of open-label repeated doses of APL-130277 or APO-goÂ® (at the dose determined in the first part) for 28 days, and then cross-over to the other drug for repeat doses for 28 days.","An Open-Label, Randomized, Crossover Trial Utilizing a Single-Blinded Rater to Evaluate APL-130277 Compared to Subcutaneous Apomorphine in Levodopa Responsive Subjects With Parkinson's Disease Complicated by Motor Fluctuations","CTH-302","Motor OFF Episodes Associated With Parkinson's Disease","Parkinson Disease","Central Nervous System Diseases","Central Nervous System","Experimental|Active Comparator","APL-130277|APO-goÂ®:","APL-130277: Part 1- determine the dose; Part 2- 28-day repeat dosing at the dose determined in Part 1|APO-goÂ®: Part 1- determine the dose; Part 2- 28-day repeat dosing at the dose determined in Part 1","Drug","APL-130277|APO-go&#xAE;","APL-130277: Part 1- determine the dose; Part 2- 28-day repeat dosing at the dose determined in Part 1|: APO-goÂ® Part 1- determine the dose; Part 2- 28-day repeat dosing at the dose determined in Part 1","no other names|apomorphine","APL-130277|APO-goÂ®:","\n\n * 1. Male or female â‰¥ 18 years of age.2. Clinical diagnosis of Idiopathic PD, consistent with UK Brain Bank Criteria.\n   \n   3. Clinically meaningful response to L-Dopa as determined by the Investigator.\n   \n   4. Receiving stable doses of L-Dopa/carbidopa and/or L-Dopa/benserazide and/or L-Dopa/ carbidopa/ entacapone (immediate or chronic release) administered at least 4 times per day OR Rytaryâ„¢ administered at least 3 times per day, and on stable doses for at least4 weeks before the initial Screening Visit (SV1). Adjunctive PD medication regimens are permitted but must be maintained at a stable does for at least 4 weeks prior to SV1 with the exception of monoamine oxidase B MAO-B) inhibitors, which must be maintained at a stable level for at least 8 weeks prior to SV1.\n   \n   5. No planned medication change(s) or surgical intervention anticipated during the course of study.\n   \n   6. Subjects must experience at least one well defined \"OFF\" episode per day with a total daily \"OFF\" time duration of > 2 hours during the waking day, based on judgment of physician and subject self-assessment.\n   \n   7. Subject must have predictable morning \"OFF\" periods.\n   \n   8. Subject and where appropriate, caregiver, must be trained in completing the home dosing diary and able to recognize \"ON\" and \"OFF\" states.\n   \n   9. Stage III or less on the modified Hoehn and Yahr scale in the \"ON\" state.\n   \n   10. Mini-Mental State Examination (MMSE) score > 25.\n   \n   11. Female subject of childbearing potential and male subject with female partner of childbearing potential must agree to use an effective and medically acceptable form of birth control throughout the study period. Note: Continued use of an effective and medically acceptable form of birth control is recommended through 30 days after study completion.\n   \n   12. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study related procedures to complete the study.\n   \n   13. Able to understand the consent form, and to provide written informed consent.\n   \n   14. Must be approved as a satisfactory candidate by the Enrollment Adjudication Committee (EAC).\n   \n   \n\n","\n\n * 1.Atypical or secondary parkinsonism.2. Previous treatment with any of the following: a neurosurgical procedure for PD; continuous subcutaneous (s.c.) apomorphine infusion; subcutaneous (s.c.) apomorphine injection; Duodopa/Duopa; or APL-130277.\n   \n   3. Contraindications to domperidone, subcutaneous apomorphine, or hypersensitivity to apomorphine, hydrochloride or any of the ingredients of subcutaneous apomorphine (notably sodium metabisulfite).\n   \n   4. Female who is pregnant or lactating.\n   \n   5. Participation in a clinical trial within 30 days prior to SV1.\n   \n   6. Receipt of any investigational (ie, unapproved) medication within 30 days prior to SV1.\n   \n   7. Currently taking selective 5HT3 antagonists (ie, ondansetron, granisetron, dolasetron, palonosetron, alosetron), dopamine antagonists (excluding quetiapine or clozapine) or dopamine depleting agents. Subjects receiving anti-depressants must be on a stable daily dose for at least 8 weeks before SV1.\n   \n   8. The subject has a current diagnosis or history of substance abuse (excluding cannabinoids, nicotine, and caffeine) or alcohol abuse (in the opinion of the investigator) < 6 months prior to SV1.\n   \n   9. Subject has a history of malignancy within 5 years prior to SV1, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer. Pituitary tumors of any duration are excluded.\n   \n   10. Subject has a clinically significant abnormality on screening evaluation including physical examination, vital signs, ECG, or laboratory tests that the Investigator considers to be inappropriate to allow participation in the study.\n   \n   11. Subject has screening laboratory test results of: blood urea nitrogen (BUN) value â‰¥ 1.5 times the upper limit of normal (ULN) for the reference range; serum creatinine > 1.5 times the ULN for the reference range; or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value value â‰¥ 2 times the ULN for the reference laboratory.\n   \n   12. Subject is on injectable medication for the treatment of Type 2 diabetes. A subject with\n   \n   \n\nType 2 diabetes is eligible for study inclusion if considered clinically stable, which is defined as:\n\n * Random (non-fasting) screening glucose is < 200 mg/dl (11.1 mmol/L); andâ€¢ HbA1c â‰¤ 6.5%; and\n * If a subject is currently being treated with oral anti-diabetic medication(s), the dose must have been stable for at least 4 weeks prior to screening. Such medication may be adjusted or discontinued during the study, as clinically indicated.\n\nNote: If the subject's random (non-fasting) screening glucose is â‰¥ 200 mg/dL (11.1 mmol/L), glucose must be retested in a fasted state. If the retested fasted value is â‰¥ 126 mg/dL (7.0 mmol/L), the subject will be excluded.\n\n13. The subject's screening ECG at SV1 or SV2 shows a corrected QT interval using Fridericia's formula (QTcF) of â‰¥ 450 msec for male subjects or â‰¥ 470 msec for female subjects. Eligibility will be based on the core laboratory ECG interpretation report.\n\n14. Subject has a positive screening laboratory test result for human immunodeficiency virus (HIV).\n\n15. Subject has a positive screening laboratory test result for hepatitis B surface antigen or hepatitis C antibodies and has liver function test results at screening above the ULN for the reference laboratory.\n\n16. Subject has major psychiatric disorder, including but not limited to in the last 12 months: bipolar disorder, psychosis (including hallucinations), major depressive episode, or any disorder that, in the opinion of the Investigator, requires new or ongoing treatment that would make study participation unsafe or make treatment compliance difficult.\n\n17. Subject has Parkinson's disease psychosis (PDP) that precludes providing informed consent or would interfere with participation in the study. Symptoms of PDP commonly include visual hallucinations, delusions (paranoia) and illusions (misperception of objects).\n\n18. History of clinically significant impulse control disorder(s).\n\n19. Orthostatic hypotension (defined clinically as requiring medication).\n\n20. Dementia that precludes providing informed consent or would interfere with participation in the study.\n\n21. Current suicidal ideation within one year prior to Screening Visit 2 (SV2) as evidenced by answering \"yes\" to Questions 4 or 5 on the suicidal ideation portion of the Columbia-Suicide Severity Rating Scale (C-SSRS) or attempted suicide within the last 5 years.\n\n22. Presence of canker or mouth sores in the 30 days prior to SV1, or other clinically significant oral pathology in the opinion of the Investigator. The Investigator should follow-up with an appropriate specialist on any finding, if indicated before enrolling a subject into the study.","MAOB","monoamine oxidase B","Gene","Prostate","Actual","2018-01-05","Actual","Anticipated","2019-05-24","Anticipated","2018-02-01","2018-01-02","2018-01-02","2018-02-27","No","Parkinson's Disease\n\"Off\" Episodes\nmotor fluctuations associated with Parkinson's Disease","Interventional","Treatment","Crossover Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":4},"Yes",{"$nulls":12},"2016-003456-70","EudraCT Number","Percentage of subjects preferring sublingual APL-130277 (apomorphine) compared to percentage of subjects preferring subcutaneous APO-go (apomorphine).","Over the entire study (approx. 85 days).",null,"Mean change from pre-dose in MDS-UPDRS Part III Motor Examination score at 90 minutes post-dose.|MDS-UPDRS Part II Motor Aspects of Experiences of Daily Living. mean change from Screening in the MDS-UPDRS Part II sum score|Patient Global Impression of Improvement (PGI):The percentage of subjects improved (ie, very much improved, much improved or minimally improved)|Percentage of subjects without a worsening of troublesome dyskinesia (dyskinesia in the last month is less than usual)|Parkinson's Disease Questionnaire-39 (PDQ-39) mean change from Screening in Summary Index score|Percentage of subjects with investigator confirmed Full \"ON\" within 30 minutes post-dose","Part B Visit 3 and 6 (after 4 weeks of dosing in each crossover period of PART B)|Part B V3 and 6 (after 4 weeks of dosing in each crossover period of PART B)",null,"clinicaltrialsdisclousre@sunovion.com","CNS Medical Director","1-866-503-6351",{"$nulls":7},"CNS Medical Director","2018-02-27","2020-05-25T16:35:25.684","2020-05-26T17:10:42.972","NCT03391882"]
["5ecbf3cd11702c1b1b9169ce","NCT03391882","2018-05-30","Sunovion","SEPR","Not yet recruiting","A Study of an Investigational Drug to See How it Affects the People With Parkinson's Disease Complicated by Motor Fluctuations (\"OFF\" Episodes) Compared to an Approved Drug Used to Treat People With Parkinson's Disease Complicated by Motor Fluctuations (\"OFF\" Episodes)","Apomorphine","DS Agonist","No",null,"No",null,"Phase 3",2,85,"Anticipated","2018-07-02","2019-05-24",{"$nulls":5},"A study of an investigational drug to see how it affects the people with Parkinson's Disease complicated by motor fluctuations (\"OFF\" Episodes) compared to an approved drug used to treat people with Parkinson's Disease complicated by motor fluctuations (\"OFF\" Episodes)","An Open-Label, Randomized, Crossover Trial utilizing a Single-Blinded Rater to evaluate sublingual administered APL-130277 (apomorphine) compared to subcutaneously administered APO-goÂ® (apomorphine) in Levodopa Responsive Subjects with Parkinson's Disease complicated by motor fluctuations.\n\nThis is a two part study. The first part consists of an open-label, crossover titration phase where subjects will be randomly assigned to APL-130277 or APO-goÂ® and titrated to the dose that turns them from the practically defined \"OFF\" state to the full \"ON\" state. They will then be crossed over to the other drug and similarly titrated to the dose that provides a full \"ON\" state.\n\nThe second part of the study consists of open-label repeated doses of APL-130277 or APO-goÂ® (at the dose determined in the first part) for 28 days, and then cross-over to the other drug for repeat doses for 28 days.","An Open-Label, Randomized, Crossover Trial Utilizing a Single-Blinded Rater to Evaluate APL-130277 Compared to Subcutaneous Apomorphine in Levodopa Responsive Subjects With Parkinson's Disease Complicated by Motor Fluctuations","CTH-302","Motor OFF Episodes Associated With Parkinson's Disease","Parkinson Disease","Central Nervous System Diseases","Central Nervous System","Experimental|Active Comparator","APL-130277|APO-goÂ®:","APL-130277: Part 1- determine the dose; Part 2- 28-day repeat dosing at the dose determined in Part 1|APO-goÂ®: Part 1- determine the dose; Part 2- 28-day repeat dosing at the dose determined in Part 1","Drug","APL-130277|APO-go&#xAE;","APL-130277: Part 1- determine the dose; Part 2- 28-day repeat dosing at the dose determined in Part 1|: APO-goÂ® Part 1- determine the dose; Part 2- 28-day repeat dosing at the dose determined in Part 1","no other names|apomorphine","APL-130277|APO-goÂ®:","\n\n * 1. Male or female â‰¥ 18 years of age.2. Clinical diagnosis of Idiopathic PD, consistent with UK Brain Bank Criteria.\n   \n   3. Clinically meaningful response to L-Dopa as determined by the Investigator.\n   \n   4. Receiving stable doses of L-Dopa/carbidopa and/or L-Dopa/benserazide and/or L-Dopa/ carbidopa/ entacapone (immediate or chronic release) administered at least 4 times per day OR Rytaryâ„¢ administered at least 3 times per day, and on stable doses for at least4 weeks before the initial Screening Visit (SV1). Adjunctive PD medication regimens are permitted but must be maintained at a stable does for at least 4 weeks prior to SV1 with the exception of monoamine oxidase B MAO-B) inhibitors, which must be maintained at a stable level for at least 8 weeks prior to SV1.\n   \n   5. No planned medication change(s) or surgical intervention anticipated during the course of study.\n   \n   6. Subjects must experience at least one well defined \"OFF\" episode per day with a total daily \"OFF\" time duration of > 2 hours during the waking day, based on judgment of physician and subject self-assessment.\n   \n   7. Subject must have predictable morning \"OFF\" periods.\n   \n   8. Subject and where appropriate, caregiver, must be trained in completing the home dosing diary and able to recognize \"ON\" and \"OFF\" states.\n   \n   9. Stage III or less on the modified Hoehn and Yahr scale in the \"ON\" state.\n   \n   10. Mini-Mental State Examination (MMSE) score > 25.\n   \n   11. Female subject of childbearing potential and male subject with female partner of childbearing potential must agree to use an effective and medically acceptable form of birth control throughout the study period. Note: Continued use of an effective and medically acceptable form of birth control is recommended through 30 days after study completion.\n   \n   12. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study related procedures to complete the study.\n   \n   13. Able to understand the consent form, and to provide written informed consent.\n   \n   14. Must be approved as a satisfactory candidate by the Enrollment Adjudication Committee (EAC).\n   \n   \n\n","\n\n * 1.Atypical or secondary parkinsonism.2. Previous treatment with any of the following: a neurosurgical procedure for PD; continuous subcutaneous (s.c.) apomorphine infusion; subcutaneous (s.c.) apomorphine injection; Duodopa/Duopa; or APL-130277.\n   \n   3. Contraindications to domperidone, subcutaneous apomorphine, or hypersensitivity to apomorphine, hydrochloride or any of the ingredients of subcutaneous apomorphine (notably sodium metabisulfite).\n   \n   4. Female who is pregnant or lactating.\n   \n   5. Participation in a clinical trial within 30 days prior to SV1.\n   \n   6. Receipt of any investigational (ie, unapproved) medication within 30 days prior to SV1.\n   \n   7. Currently taking selective 5HT3 antagonists (ie, ondansetron, granisetron, dolasetron, palonosetron, alosetron), dopamine antagonists (excluding quetiapine or clozapine) or dopamine depleting agents. Subjects receiving anti-depressants must be on a stable daily dose for at least 8 weeks before SV1.\n   \n   8. The subject has a current diagnosis or history of substance abuse (excluding cannabinoids, nicotine, and caffeine) or alcohol abuse (in the opinion of the investigator) < 6 months prior to SV1.\n   \n   9. Subject has a history of malignancy within 5 years prior to SV1, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer. Pituitary tumors of any duration are excluded.\n   \n   10. Subject has a clinically significant abnormality on screening evaluation including physical examination, vital signs, ECG, or laboratory tests that the Investigator considers to be inappropriate to allow participation in the study.\n   \n   11. Subject has screening laboratory test results of: blood urea nitrogen (BUN) value â‰¥ 1.5 times the upper limit of normal (ULN) for the reference range; serum creatinine > 1.5 times the ULN for the reference range; or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value value â‰¥ 2 times the ULN for the reference laboratory.\n   \n   12. Subject is on injectable medication for the treatment of Type 2 diabetes. A subject with\n   \n   \n\nType 2 diabetes is eligible for study inclusion if considered clinically stable, which is defined as:\n\n * Random (non-fasting) screening glucose is < 200 mg/dl (11.1 mmol/L); andâ€¢ HbA1c â‰¤ 6.5%; and\n * If a subject is currently being treated with oral anti-diabetic medication(s), the dose must have been stable for at least 4 weeks prior to screening. Such medication may be adjusted or discontinued during the study, as clinically indicated.\n\nNote: If the subject's random (non-fasting) screening glucose is â‰¥ 200 mg/dL (11.1 mmol/L), glucose must be retested in a fasted state. If the retested fasted value is â‰¥ 126 mg/dL (7.0 mmol/L), the subject will be excluded.\n\n13. The subject's screening ECG at SV1 or SV2 shows a corrected QT interval using Fridericia's formula (QTcF) of â‰¥ 450 msec for male subjects or â‰¥ 470 msec for female subjects. Eligibility will be based on the core laboratory ECG interpretation report.\n\n14. Subject has a positive screening laboratory test result for human immunodeficiency virus (HIV).\n\n15. Subject has a positive screening laboratory test result for hepatitis B surface antigen or hepatitis C antibodies and has liver function test results at screening above the ULN for the reference laboratory.\n\n16. Subject has major psychiatric disorder, including but not limited to in the last 12 months: bipolar disorder, psychosis (including hallucinations), major depressive episode, or any disorder that, in the opinion of the Investigator, requires new or ongoing treatment that would make study participation unsafe or make treatment compliance difficult.\n\n17. Subject has Parkinson's disease psychosis (PDP) that precludes providing informed consent or would interfere with participation in the study. Symptoms of PDP commonly include visual hallucinations, delusions (paranoia) and illusions (misperception of objects).\n\n18. History of clinically significant impulse control disorder(s).\n\n19. Orthostatic hypotension (defined clinically as requiring medication).\n\n20. Dementia that precludes providing informed consent or would interfere with participation in the study.\n\n21. Current suicidal ideation within one year prior to Screening Visit 2 (SV2) as evidenced by answering \"yes\" to Questions 4 or 5 on the suicidal ideation portion of the Columbia-Suicide Severity Rating Scale (C-SSRS) or attempted suicide within the last 5 years.\n\n22. Presence of canker or mouth sores in the 30 days prior to SV1, or other clinically significant oral pathology in the opinion of the Investigator. The Investigator should follow-up with an appropriate specialist on any finding, if indicated before enrolling a subject into the study.","MAOB","monoamine oxidase B","Gene","Prostate","Actual","2018-01-05","Actual","Anticipated","2019-05-24","Anticipated","2018-05-01","2018-01-02","2018-01-02","2018-05-29","No","Parkinson's Disease\n\"Off\" Episodes\nmotor fluctuations associated with Parkinson's Disease","Interventional","Treatment","Crossover Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":4},"Yes",{"$nulls":12},"2016-003456-70","EudraCT Number","Percentage of subjects preferring sublingual APL-130277 (apomorphine) compared to percentage of subjects preferring subcutaneous APO-go (apomorphine).","Over the entire study (approx. 85 days).",null,"Mean change from pre-dose in MDS-UPDRS Part III Motor Examination score at 90 minutes post-dose.|MDS-UPDRS Part II Motor Aspects of Experiences of Daily Living. mean change from Screening in the MDS-UPDRS Part II sum score|Patient Global Impression of Improvement (PGI):The percentage of subjects improved (ie, very much improved, much improved or minimally improved)|Percentage of subjects without a worsening of troublesome dyskinesia (dyskinesia in the last month is less than usual)|Parkinson's Disease Questionnaire-39 (PDQ-39) mean change from Screening in Summary Index score|Percentage of subjects with investigator confirmed Full \"ON\" within 30 minutes post-dose","Part B Visit 3 and 6 (after 4 weeks of dosing in each crossover period of PART B)|Part B V3 and 6 (after 4 weeks of dosing in each crossover period of PART B)",null,"clinicaltrialsdisclousre@sunovion.com","CNS Medical Director","1-866-503-6351",{"$nulls":7},"CNS Medical Director","2018-05-29","2020-05-25T16:35:25.672","2020-05-26T17:10:42.972","NCT03391882"]
["5ecbf3cefe30261b1a0481bc","NCT03391882","2018-07-09","Sunovion","SEPR","Not yet recruiting","A Study of an Investigational Drug to See How it Affects the People With Parkinson's Disease Complicated by Motor Fluctuations (\"OFF\" Episodes) Compared to an Approved Drug Used to Treat People With Parkinson's Disease Complicated by Motor Fluctuations (\"OFF\" Episodes)","Apomorphine","DS Agonist","No",null,"No",null,"Phase 3",2,106,"Anticipated","2018-07-30","2020-05-24",{"$nulls":5},"A study of an investigational drug to see how it affects the people with Parkinson's Disease complicated by motor fluctuations (\"OFF\" Episodes) compared to an approved drug used to treat people with Parkinson's Disease complicated by motor fluctuations (\"OFF\" Episodes)","An Open-Label, Randomized, Crossover Trial utilizing a Single-Blinded Rater to evaluate APL-130277 compared to s.c. Apomorphine in Levodopa Responsive Subjects with Parkinson's Disease Complicated by Motor Fluctuations.\n\nPART A consists of an open label, crossover titration phase where eligible subjects will be randomized to 1 of 2 treatment sequences in a 1:1 ratio to Sublingual APL 130277 followed by subcutaneous apomorphine or subcutaneous apomorphine followed by sublingual APL 130277. Subjects will then be titrated with the first study treatment (APL 130277 or sc apomorphine) to tolerance and effect, ie, the tolerable dose that turns the subject from the practically defined \"OFF\" state to the full \"ON\" state as determined by both the Investigator and subject. The subject will then be crossed over to the other study treatment (APL 130277 or subcutaneous apomorphine) and similarly titrated to tolerance and effect. These determined doses of APL 130277 and subcutaneous apomorphine will be used during PART B.\n\nPART B consists of an open-label, crossover treatment period where subjects will be randomized to one of the study treatment for 4 weeks, then be crossed over to the other study treatment (APL-130277 or sc apomorphine) for additional 4-weeks of open-label treatment. Subjects return to the clinic for safety and efficacy assessments throughout the treatment period.\n\nThis study is designed to test the superiority of sublingually administered APL-130277 against subcutaneously injected apomorphine (APO-go) for the treatment of \"OFF\" episodes in patients with Parkinson's Disease, as measured by the change from pre-dose to 90 minutes post-dose in MDS UPDRS Part III score in Part B after 4 weeks of dosing in each crossover period.","An Open-Label, Randomized, Crossover Trial Utilizing a Single-Blinded Rater to Evaluate APL-130277 Compared to Subcutaneous Apomorphine in Levodopa Responsive Subjects With Parkinson's Disease Complicated by Motor Fluctuations","CTH-302","Motor OFF Episodes Associated With Parkinson's Disease","Parkinson Disease","Central Nervous System Diseases","Central Nervous System","Experimental|Active Comparator","APL-130277|subcutaneous apomorphine","APL-130277: Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A|subcutaneous apomorphine , Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A","Drug","APL-130277|subcutaneous apomorphine","APL-130277: Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A|subcutaneous apomorphine Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A","Apomorphine Hydrochloride|APO-goÂ®","APL-130277|subcutaneous apomorphine","\n\n 1.  The subject (and caregiver, if applicable) must be fully informed of and understand the objectives, procedures, and possible benefits and risks of the study, and give written informed consent prior to performing any study related activities.\n 2.  Male or female â‰¥ 18 years of age.\n 3.  Clinical diagnosis of Idiopathic PD, consistent with UK Brain Bank Criteria (excluding the \"more than one affected relative\" criterion).\n 4.  Clinically meaningful response to levodopa (L-Dopa), as determined by the Investigator.\n 5.  Subjects at screening must demonstrate an adequate L-Dopa response on the MDS UPDRS Part III in the \"ON\" state compared to the MDS UPDRS Part III in the \"OFF\" state and on the Hoehn and Yahr, as determined during the review by Enrollment Adjudication Committee (EAC), Sponsor, and Medical Monitor.\n 6.  Receiving stable doses of L Dopa/carbidopa and/or L Dopa/benserazide and/or L Dopa/carbidopa/entacapone (immediate or chronic release) administered at least 4 times per day OR Rytaryâ„¢ administered at least 3 times per day for at least 4 weeks before the initial screening Visit (SV1). Adjunctive PD medication regimens are permitted but must be maintained at a stable dose for at least 4 weeks prior to SV1 with the exception of monoamine oxidase B (MAO B) inhibitors, which must be maintained at a stable level for at least 8 weeks prior to SV1.\n 7.  No planned medication change(s) or surgical intervention anticipated during the course of study.\n 8.  Subjects must experience at least one well defined \"OFF\" episode per day and have a total daily \"OFF\" time duration of > 2 hours during the waking day, based on judgment of physician and subject self assessment.\n 9.  Subject must have predictable morning \"OFF\" periods, based on judgment of physician and subject self assessment.\n 10. Subject, and where appropriate caregiver, must be trained in completing the home dosing diaries and able to recognize \"ON\" and \"OFF\" states.\n 11. Stage III or less on the modified Hoehn and Yahr scale in the \"ON\" state.\n 12. Mini-Mental State Examination (MMSE) score > 25.\n 13. Female subject of childbearing potential and male subject with female partner of childbearing potential must agree to either remain abstinent or use adequate and reliable contraception throughout the study and for at least 7 days after the last dose of study drug has been taken. Note: Continued use of adequate and reliable contraception is recommended through 30 days after study completion.\n 14. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study related procedures to complete the study.\n 15. Must be approved as a satisfactory candidate by the Enrollment Adjudication Committee (EAC), Medical Monitor, and Sponsor.\n\n","\n\n","MAOB","monoamine oxidase B","Gene","Prostate","Actual","2018-01-05","Actual","Anticipated","2020-05-31","Anticipated","2018-07-01","2018-01-02","2018-01-02","2018-07-05","No","Parkinson's Disease\n\"Off\" Episodes\nmotor fluctuations associated with Parkinson's Disease","Interventional","Treatment","Crossover Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":4},"Yes",{"$nulls":12},"2016-003456-70","EudraCT Number","change from pre-dose to 90 minutes post-dose in MDS UPDRS Part III score after 4 weeks of dosing in each crossover period (assessed by the blinded-rater in-clinic at Visit 3 and Visit 6 of PART B).","Week 4",null,"Durability of effect, defined as an Investigator confirmed full \"ON\" within 30 minutes post dose and at 90 minutes post-dose, after 4 weeks of dosing in each crossover period (assessed by the blinded-rater in-clinic at Visit 3 and Visit 6 of PART B).|Subject preference for treatment regimen as measured by the Subject Preference Visual Analog Scale (VAS) after the subject has completed both APL 130277 and sc apomorphine treatment regimens (assessed in-clinic at Visit 6 of PART B).|Per the Expanded Home Dosing Diary, percent of \"ON\" episodes without troublesome dyskinesia based on the 3 consecutive days prior to Visit 2, Visit 3, Visit 5, and Visit 6.|Subject confirmed durability of effect, defined as subject confirmed full \"ON\" within 30 minutes post-dose and at 90 minutes post-dose, after 4 weeks of dosing in each crossover period (assessed in-clinic at Visit 3 and Visit 6 of PART B).|Patient Global Impression of Change (PGI-C): Subject improvement of \"OFF\" episodes, defined as very much better, much better or a little better after 4 weeks of dosing in each crossover period (assessed in-clinic at Visit 3 and Visit 6 of PART B).","Week 4|with a recorded range of -50 to 50. Negative values indicate preference for SC treatment, and the more negative the value, the stronger is the preference for SC compared to APL treatment. Positive values indicate preference for APL treatment, and the more positive the value, the stronger is the preference for APL compared to SC treatment. A value of 0 indicates no preference of one treatment over the other.","Week 4","clinicaltrialsdisclousre@sunovion.com","CNS Medical Director","1-866-503-6351",{"$nulls":7},"CNS Medical Director","2018-07-05","2020-05-25T16:35:26.323","2020-05-26T17:10:42.972","NCT03391882"]
["5ecbf3cdfe30261b1a0481bb","NCT03391882","2018-08-10","Sunovion","SEPR","Not yet recruiting","A Study of an Investigational Drug to See How it Affects the People With Parkinson's Disease Complicated by Motor Fluctuations (\"OFF\" Episodes) Compared to an Approved Drug Used to Treat People With Parkinson's Disease Complicated by Motor Fluctuations (\"OFF\" Episodes)","Apomorphine","DS Agonist","No",null,"No",null,"Phase 3",2,106,"Anticipated","2018-07-30","2020-05-24",{"$nulls":5},"A study of an investigational drug to see how it affects the people with Parkinson's Disease complicated by motor fluctuations (\"OFF\" Episodes) compared to an approved drug used to treat people with Parkinson's Disease complicated by motor fluctuations (\"OFF\" Episodes)","An Open-Label, Randomized, Crossover Trial utilizing a Single-Blinded Rater to evaluate APL-130277 compared to s.c. Apomorphine in Levodopa Responsive Subjects with Parkinson's Disease Complicated by Motor Fluctuations.\n\nPART A consists of an open label, crossover titration phase where eligible subjects will be randomized to 1 of 2 treatment sequences in a 1:1 ratio to Sublingual APL 130277 followed by subcutaneous apomorphine or subcutaneous apomorphine followed by sublingual APL 130277. Subjects will undergo dose titration with the first study treatment (APL 130277 or sc apomorphine) to tolerance and effect, ie, the tolerable dose that turns the subject from the practically defined \"OFF\" state to the full \"ON\" state as determined by both the Investigator and subject. The subject will then be crossed over to the other study treatment (APL 130277 or subcutaneous apomorphine) and similarly titrated to tolerance and effect. These determined doses of APL 130277 and subcutaneous apomorphine will be used during PART B.\n\nPART B consists of an open-label, crossover treatment period where subjects will be randomized to one of the study treatment for 4 weeks, then be crossed over to the other study treatment (APL-130277 or sc apomorphine) for additional 4-weeks of open-label treatment. Subjects return to the clinic for safety and efficacy assessments throughout the treatment period.\n\nThis study is designed to test the superiority of sublingually administered APL-130277 against subcutaneously injected apomorphine (APO-go) for the treatment of \"OFF\" episodes in patients with Parkinson's Disease, as measured by the change from pre-dose to 90 minutes post-dose in MDS UPDRS Part III score in Part B after 4 weeks of dosing in each crossover period.","An Open-Label, Randomized, Crossover Trial Utilizing a Single-Blinded Rater to Evaluate APL-130277 Compared to Subcutaneous Apomorphine in Levodopa Responsive Subjects With Parkinson's Disease Complicated by Motor Fluctuations","CTH-302","Motor OFF Episodes Associated With Parkinson's Disease","Parkinson Disease","Central Nervous System Diseases","Central Nervous System","Experimental|Active Comparator","APL-130277|subcutaneous apomorphine","APL-130277: Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A|subcutaneous apomorphine , Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A","Drug","APL-130277|subcutaneous apomorphine","APL-130277: Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A|subcutaneous apomorphine Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A","Apomorphine Hydrochloride|APO-goÂ®","APL-130277|subcutaneous apomorphine","\n\n 1.  The subject (and caregiver, if applicable) must be fully informed of and understand the objectives, procedures, and possible benefits and risks of the study, and give written informed consent prior to performing any study related activities.\n 2.  Male or female â‰¥ 18 years of age.\n 3.  Clinical diagnosis of Idiopathic PD, consistent with UK Brain Bank Criteria (excluding the \"more than one affected relative\" criterion).\n 4.  Clinically meaningful response to levodopa (L-Dopa), as determined by the Investigator.\n 5.  Subjects at screening must demonstrate an adequate L-Dopa response on the MDS UPDRS Part III in the \"ON\" state compared to the MDS UPDRS Part III in the \"OFF\" state and on the Hoehn and Yahr, as determined during the review by Enrollment Adjudication Committee (EAC), Sponsor, and Medical Monitor.\n 6.  Receiving stable doses of L Dopa/carbidopa and/or L Dopa/benserazide and/or L Dopa/carbidopa/entacapone (immediate or chronic release) administered at least 4 times per day OR Rytaryâ„¢ administered at least 3 times per day for at least 4 weeks before the initial screening Visit (SV1). Adjunctive PD medication regimens are permitted but must be maintained at a stable dose for at least 4 weeks prior to SV1 with the exception of monoamine oxidase B (MAO B) inhibitors, which must be maintained at a stable level for at least 8 weeks prior to SV1.\n 7.  No planned medication change(s) or surgical intervention anticipated during the course of study.\n 8.  Subjects must experience at least one well defined \"OFF\" episode per day and have a total daily \"OFF\" time duration of > 2 hours during the waking day, based on judgment of physician and subject self assessment.\n 9.  Subject must have predictable morning \"OFF\" periods, based on judgment of physician and subject self assessment.\n 10. Subject, and where appropriate caregiver, must be trained in completing the home dosing diaries and able to recognize \"ON\" and \"OFF\" states.\n 11. Stage III or less on the modified Hoehn and Yahr scale in the \"ON\" state.\n 12. Mini-Mental State Examination (MMSE) score > 25.\n 13. Female subject of childbearing potential and male subject with female partner of childbearing potential must agree to either remain abstinent or use adequate and reliable contraception throughout the study and for at least 7 days after the last dose of study drug has been taken. Note: Continued use of adequate and reliable contraception is recommended through 30 days after study completion.\n 14. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study related procedures to complete the study.\n 15. Must be approved as a satisfactory candidate by the Enrollment Adjudication Committee (EAC), Medical Monitor, and Sponsor.\n\n","\n\n 1.  Atypical or secondary parkinsonism.\n 2.  Major focal brain disorders including malignancy or stroke.\n 3.  Prior treatment with any of the following: a neurosurgical procedure for PD; continuous subcutaneous (subcutaneous) apomorphine infusion; subcutaneous (subcutaneous) apomorphine injection; Duodopa/Duopa; or APL-130277.\n 4.  Contraindications to domperidone, subcutaneous apomorphine, or hypersensitivity to apomorphine hydrochloride or any of the ingredients of subcutaneous apomorphine (notably sodium metabisulfite).\n 5.  Female who is pregnant or lactating.\n 6.  Participation in an interventional clinical study and/or receipt of any investigational (ie, unapproved) medication within 30 days prior to SV1.\n 7.  Currently taking selective 5HT3 antagonists (ie, ondansetron, granisetron, dolasetron, palonosetron, alosetron), dopamine antagonists (excluding quetiapine or clozapine) or dopamine depleting agents. Subjects receiving anti depressants must be on a stable daily dose for at least 8 weeks prior to SV1.\n 8.  The subject has a current diagnosis or history of substance abuse (excluding nicotine and caffeine) or alcohol abuse (in the opinion of the investigator) < 6 months prior to SV1.\n 9.  The recreational use of cannabinoids and hallucinogenic are excluded, as well any use of a sublingual formulation of any drug.\n 10. Subject has a history of malignancy within 5 years prior to SV1, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.\n 11. Subject has a clinically significant abnormality on screening evaluation including physical examination, vital signs, electrocardiogram (ECG), or laboratory tests that the Investigator considers to be inappropriate to allow participation in the study.\n 12. Subject has screening laboratory test results of: blood urea nitrogen (BUN) value â‰¥ 1.5 times the upper limit of normal (ULN) for the reference range; serum creatinine > 1.5 times the ULN for the reference range; or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value â‰¥ 2 times the ULN for the reference laboratory.\n 13. Subject has random (non-fasting) screening glucose of â‰¥ 200 mg/dL (11.1 mmol/L) or HbA1c > 7.0%.\n 14. Subjects with type 1 diabetes, or insulin dependent diabetics are excluded. Subjects with type 2 diabetes are eligible for study inclusion if the following conditions are met: * Subject's screening glucose is < 200 mg/dL (11.1 mmol/L). Note: Subjects with random (non fasting) blood glucose at screening â‰¥ 200 mg/dL (11.1 mmol/L) must be retested in a fasted state; and\n      * Subject's hemoglobin A1c (HbA1c) â‰¤ 7.0%; and\n      * If the subject is currently being treated with oral anti-diabetic medication(s), the dose must have been stable for at least 4 weeks prior to SV1. Such medication may be adjusted or discontinued during the study, as clinically indicated.\n     \n     \n 15. The subject's screening ECG results of corrected QT interval using Fridericia's formula (QTcF) â‰¥ 450 msec for male subjects or â‰¥ 470 msec for female subjects. Eligibility will be based on the core laboratory ECG interpretation report.\n 16. Subject has a positive screening laboratory test result for human immunodeficiency virus (HIV).\n 17. Subject has a positive screening laboratory test result for hepatitis B surface antigen or hepatitis C antibodies and has liver function test results at screening above the ULN for the reference laboratory.\n 18. Subject has any other medical disorder that, in the opinion of the Investigator, could interfere with the subject's participation in the study.\n 19. Subject has major psychiatric disorder(s), including but not limited to: bipolar disorder, psychosis (eg, Parkinson's Disease Psychosis), major depressive episode, or any disorder that, in the opinion of the Investigator, would require treatment that could make study participation unsafe or make treatment compliance difficult.\n 20. History of clinically significant impulse control disorder(s).\n 21. History of symptomatic orthostatic hypotension requiring medication.\n 22. History of severe dyskinesia based on a score of 4 on the MDS-UPDRS Part IV.\n 23. Dementia that precludes providing informed consent or would interfere with participation in the study.\n 24. Current/recent suicidal ideation as evidenced by answering \"yes\" to \"Suicidal Ideation\" item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) on the C-SSRS assessment at screening (using the \"screening /Baseline Version\" scale, in the past 12 months) or attempted suicide within the last 5 years.\n 25. Presence of canker or mouth sores in the 30 days prior to SV1, or other clinically significant oral pathology in the opinion of the Investigator. The Investigator should follow-up with an appropriate specialist on any finding, if indicated, before enrolling a subject into the study","MAOB","monoamine oxidase B","Gene","Prostate","Actual","2018-01-05","Actual","Anticipated","2020-05-31","Anticipated","2018-08-01","2018-01-02","2018-01-02","2018-08-08","No","Parkinson's Disease\n\"Off\" Episodes\nmotor fluctuations associated with Parkinson's Disease","Interventional","Treatment","Crossover Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":4},"Yes",{"$nulls":12},"2016-003456-70","EudraCT Number","change from pre-dose to 90 minutes post-dose in MDS UPDRS Part III score after 4 weeks of dosing in each crossover period (assessed by the blinded-rater in-clinic at Visit 3 and Visit 6 of PART B).","Week 4",null,"Durability of effect, defined as an Investigator confirmed full \"ON\" within 30 minutes post dose and at 90 minutes post-dose, after 4 weeks of dosing in each crossover period (assessed by the blinded-rater in-clinic at Visit 3 and Visit 6 of PART B).|Subject preference for treatment regimen as measured by the Subject Preference Visual Analog Scale (VAS) after the subject has completed both APL 130277 and sc apomorphine treatment regimens (assessed in-clinic at Visit 6 of PART B).|Per the Expanded Home Dosing Diary, percent of \"ON\" episodes without troublesome dyskinesia based on the 3 consecutive days prior to Visit 2, Visit 3, Visit 5, and Visit 6.|Subject confirmed durability of effect, defined as subject confirmed full \"ON\" within 30 minutes post-dose and at 90 minutes post-dose, after 4 weeks of dosing in each crossover period (assessed in-clinic at Visit 3 and Visit 6 of PART B).|Patient Global Impression of Change (PGI-C): Subject improvement of \"OFF\" episodes, defined as very much better, much better or a little better after 4 weeks of dosing in each crossover period (assessed in-clinic at Visit 3 and Visit 6 of PART B).","Week 4|with a recorded range of -50 to 50. Negative values indicate preference for SC treatment, and the more negative the value, the stronger is the preference for SC compared to APL treatment. Positive values indicate preference for APL treatment, and the more positive the value, the stronger is the preference for APL compared to SC treatment. A value of 0 indicates no preference of one treatment over the other.","Week 4","clinicaltrialsdisclousre@sunovion.com","CNS Medical Director","1-866-503-6351",{"$nulls":7},"CNS Medical Director","2018-08-08","2020-05-25T16:35:25.805","2020-05-26T17:10:42.972","NCT03391882"]
["5ecbf3cefeab101b155307eb","NCT03391882","2018-08-15","Sunovion","SEPR","Not yet recruiting","A Study of an Investigational Drug to See How it Affects the People With Parkinson's Disease Complicated by Motor Fluctuations (\"OFF\" Episodes) Compared to an Approved Drug Used to Treat People With Parkinson's Disease Complicated by Motor Fluctuations (\"OFF\" Episodes)","Apomorphine","DS Agonist","No",null,"No",null,"Phase 3",2,106,"Anticipated","2018-09-24","2020-05-24",{"$nulls":5},"A study of an investigational drug to see how it affects the people with Parkinson's Disease complicated by motor fluctuations (\"OFF\" Episodes) compared to an approved drug used to treat people with Parkinson's Disease complicated by motor fluctuations (\"OFF\" Episodes)","An Open-Label, Randomized, Crossover Trial utilizing a Single-Blinded Rater to evaluate APL-130277 compared to s.c. Apomorphine in Levodopa Responsive Subjects with Parkinson's Disease Complicated by Motor Fluctuations.\n\nPART A consists of an open label, crossover titration phase where eligible subjects will be randomized to 1 of 2 treatment sequences in a 1:1 ratio to Sublingual APL 130277 followed by subcutaneous apomorphine or subcutaneous apomorphine followed by sublingual APL 130277. Subjects will undergo dose titration with the first study treatment (APL 130277 or sc apomorphine) to tolerance and effect, ie, the tolerable dose that turns the subject from the practically defined \"OFF\" state to the full \"ON\" state as determined by both the Investigator and subject. The subject will then be crossed over to the other study treatment (APL 130277 or subcutaneous apomorphine) and similarly titrated to tolerance and effect. These determined doses of APL 130277 and subcutaneous apomorphine will be used during PART B.\n\nPART B consists of an open-label, crossover treatment period where subjects will be randomized to one of the study treatment for 4 weeks, then be crossed over to the other study treatment (APL-130277 or sc apomorphine) for additional 4-weeks of open-label treatment. Subjects return to the clinic for safety and efficacy assessments throughout the treatment period.\n\nThis study is designed to test the superiority of sublingually administered APL-130277 against subcutaneously injected apomorphine (APO-go) for the treatment of \"OFF\" episodes in patients with Parkinson's Disease, as measured by the change from pre-dose to 90 minutes post-dose in MDS UPDRS Part III score in Part B after 4 weeks of dosing in each crossover period.","An Open-Label, Randomized, Crossover Trial Utilizing a Single-Blinded Rater to Evaluate APL-130277 Compared to Subcutaneous Apomorphine in Levodopa Responsive Subjects With Parkinson's Disease Complicated by Motor Fluctuations","CTH-302","Motor OFF Episodes Associated With Parkinson's Disease","Parkinson Disease","Central Nervous System Diseases","Central Nervous System","Experimental|Active Comparator","APL-130277|subcutaneous apomorphine","APL-130277: Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A|subcutaneous apomorphine , Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A","Drug","APL-130277|subcutaneous apomorphine","APL-130277: Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A|subcutaneous apomorphine Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A","Apomorphine Hydrochloride|APO-goÂ®","APL-130277|subcutaneous apomorphine","\n\n 1.  The subject (and caregiver, if applicable) must be fully informed of and understand the objectives, procedures, and possible benefits and risks of the study, and give written informed consent prior to performing any study related activities.\n 2.  Male or female â‰¥ 18 years of age.\n 3.  Clinical diagnosis of Idiopathic PD, consistent with UK Brain Bank Criteria (excluding the \"more than one affected relative\" criterion).\n 4.  Clinically meaningful response to levodopa (L-Dopa), as determined by the Investigator.\n 5.  Subjects at screening must demonstrate an adequate L-Dopa response on the MDS UPDRS Part III in the \"ON\" state compared to the MDS UPDRS Part III in the \"OFF\" state and on the Hoehn and Yahr, as determined during the review by Enrollment Adjudication Committee (EAC), Sponsor, and Medical Monitor.\n 6.  Receiving stable doses of L Dopa/carbidopa and/or L Dopa/benserazide and/or L Dopa/carbidopa/entacapone (immediate or chronic release) administered at least 4 times per day OR Rytaryâ„¢ administered at least 3 times per day for at least 4 weeks before the initial screening Visit (SV1). Adjunctive PD medication regimens are permitted but must be maintained at a stable dose for at least 4 weeks prior to SV1 with the exception of monoamine oxidase B (MAO B) inhibitors, which must be maintained at a stable level for at least 8 weeks prior to SV1.\n 7.  No planned medication change(s) or surgical intervention anticipated during the course of study.\n 8.  Subjects must experience at least one well defined \"OFF\" episode per day and have a total daily \"OFF\" time duration of > 2 hours during the waking day, based on judgment of physician and subject self assessment.\n 9.  Subject must have predictable morning \"OFF\" periods, based on judgment of physician and subject self assessment.\n 10. Subject, and where appropriate caregiver, must be trained in completing the home dosing diaries and able to recognize \"ON\" and \"OFF\" states.\n 11. Stage III or less on the modified Hoehn and Yahr scale in the \"ON\" state.\n 12. Mini-Mental State Examination (MMSE) score > 25.\n 13. Female subject of childbearing potential and male subject with female partner of childbearing potential must agree to either remain abstinent or use adequate and reliable contraception throughout the study and for at least 7 days after the last dose of study drug has been taken. Note: Continued use of adequate and reliable contraception is recommended through 30 days after study completion.\n 14. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study related procedures to complete the study.\n 15. Must be approved as a satisfactory candidate by the Enrollment Adjudication Committee (EAC), Medical Monitor, and Sponsor.\n\n","\n\n 1.  Atypical or secondary parkinsonism.\n 2.  Major focal brain disorders including malignancy or stroke.\n 3.  Prior treatment with any of the following: a neurosurgical procedure for PD; continuous subcutaneous (subcutaneous) apomorphine infusion; subcutaneous (subcutaneous) apomorphine injection; Duodopa/Duopa; or APL-130277.\n 4.  Contraindications to domperidone, subcutaneous apomorphine, or hypersensitivity to apomorphine hydrochloride or any of the ingredients of subcutaneous apomorphine (notably sodium metabisulfite).\n 5.  Female who is pregnant or lactating.\n 6.  Participation in an interventional clinical study and/or receipt of any investigational (ie, unapproved) medication within 30 days prior to SV1.\n 7.  Currently taking selective 5HT3 antagonists (ie, ondansetron, granisetron, dolasetron, palonosetron, alosetron), dopamine antagonists (excluding quetiapine or clozapine) or dopamine depleting agents. Subjects receiving anti depressants must be on a stable daily dose for at least 8 weeks prior to SV1.\n 8.  The subject has a current diagnosis or history of substance abuse (excluding nicotine and caffeine) or alcohol abuse (in the opinion of the investigator) < 6 months prior to SV1.\n 9.  The recreational use of cannabinoids and hallucinogenic are excluded, as well any use of a sublingual formulation of any drug.\n 10. Subject has a history of malignancy within 5 years prior to SV1, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.\n 11. Subject has a clinically significant abnormality on screening evaluation including physical examination, vital signs, electrocardiogram (ECG), or laboratory tests that the Investigator considers to be inappropriate to allow participation in the study.\n 12. Subject has screening laboratory test results of: blood urea nitrogen (BUN) value â‰¥ 1.5 times the upper limit of normal (ULN) for the reference range; serum creatinine > 1.5 times the ULN for the reference range; or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value â‰¥ 2 times the ULN for the reference laboratory.\n 13. Subject has random (non-fasting) screening glucose of â‰¥ 200 mg/dL (11.1 mmol/L) or HbA1c > 7.0%.\n 14. Subjects with type 1 diabetes, or insulin dependent diabetics are excluded. Subjects with type 2 diabetes are eligible for study inclusion if the following conditions are met: * Subject's screening glucose is < 200 mg/dL (11.1 mmol/L). Note: Subjects with random (non fasting) blood glucose at screening â‰¥ 200 mg/dL (11.1 mmol/L) must be retested in a fasted state; and\n      * Subject's hemoglobin A1c (HbA1c) â‰¤ 7.0%; and\n      * If the subject is currently being treated with oral anti-diabetic medication(s), the dose must have been stable for at least 4 weeks prior to SV1. Such medication may be adjusted or discontinued during the study, as clinically indicated.\n     \n     \n 15. The subject's screening ECG results of corrected QT interval using Fridericia's formula (QTcF) â‰¥ 450 msec for male subjects or â‰¥ 470 msec for female subjects. Eligibility will be based on the core laboratory ECG interpretation report.\n 16. Subject has a positive screening laboratory test result for human immunodeficiency virus (HIV).\n 17. Subject has a positive screening laboratory test result for hepatitis B surface antigen or hepatitis C antibodies and has liver function test results at screening above the ULN for the reference laboratory.\n 18. Subject has any other medical disorder that, in the opinion of the Investigator, could interfere with the subject's participation in the study.\n 19. Subject has major psychiatric disorder(s), including but not limited to: bipolar disorder, psychosis (eg, Parkinson's Disease Psychosis), major depressive episode, or any disorder that, in the opinion of the Investigator, would require treatment that could make study participation unsafe or make treatment compliance difficult.\n 20. History of clinically significant impulse control disorder(s).\n 21. History of symptomatic orthostatic hypotension requiring medication.\n 22. History of severe dyskinesia based on a score of 4 on the MDS-UPDRS Part IV.\n 23. Dementia that precludes providing informed consent or would interfere with participation in the study.\n 24. Current/recent suicidal ideation as evidenced by answering \"yes\" to \"Suicidal Ideation\" item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) on the C-SSRS assessment at screening (using the \"screening /Baseline Version\" scale, in the past 12 months) or attempted suicide within the last 5 years.\n 25. Presence of canker or mouth sores in the 30 days prior to SV1, or other clinically significant oral pathology in the opinion of the Investigator. The Investigator should follow-up with an appropriate specialist on any finding, if indicated, before enrolling a subject into the study","MAOB","monoamine oxidase B","Gene","Prostate","Actual","2018-01-05","Actual","Anticipated","2020-05-31","Anticipated","2018-08-01","2018-01-02","2018-01-02","2018-08-14","No","Parkinson's Disease\n\"Off\" Episodes\nmotor fluctuations associated with Parkinson's Disease","Interventional","Treatment","Crossover Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":4},"Yes",{"$nulls":12},"2016-003456-70","EudraCT Number","change from pre-dose to 90 minutes post-dose in MDS UPDRS Part III score after 4 weeks of dosing in each crossover period (assessed by the blinded-rater in-clinic at Visit 3 and Visit 6 of PART B).","Week 4",null,"Durability of effect, defined as an Investigator confirmed full \"ON\" within 30 minutes post dose and at 90 minutes post-dose, after 4 weeks of dosing in each crossover period (assessed by the blinded-rater in-clinic at Visit 3 and Visit 6 of PART B).|Subject preference for treatment regimen as measured by the Subject Preference Visual Analog Scale (VAS) after the subject has completed both APL 130277 and sc apomorphine treatment regimens (assessed in-clinic at Visit 6 of PART B).|Per the Expanded Home Dosing Diary, percent of \"ON\" episodes without troublesome dyskinesia based on the 3 consecutive days prior to Visit 2, Visit 3, Visit 5, and Visit 6.|Subject confirmed durability of effect, defined as subject confirmed full \"ON\" within 30 minutes post-dose and at 90 minutes post-dose, after 4 weeks of dosing in each crossover period (assessed in-clinic at Visit 3 and Visit 6 of PART B).|Patient Global Impression of Change (PGI-C): Subject improvement of \"OFF\" episodes, defined as very much better, much better or a little better after 4 weeks of dosing in each crossover period (assessed in-clinic at Visit 3 and Visit 6 of PART B).","Week 4|with a recorded range of -50 to 50. Negative values indicate preference for SC treatment, and the more negative the value, the stronger is the preference for SC compared to APL treatment. Positive values indicate preference for APL treatment, and the more positive the value, the stronger is the preference for APL compared to SC treatment. A value of 0 indicates no preference of one treatment over the other.","Week 4","clinicaltrialsdisclousre@sunovion.com","CNS Medical Director","1-866-503-6351",{"$nulls":7},"CNS Medical Director","2018-08-14","2020-05-25T16:35:26.106","2020-05-26T17:10:42.972","NCT03391882"]
["5ecbf3cde2561b1b11905cb7","NCT03391882","2018-11-06","Sunovion","SEPR","Recruiting","A Study of an Investigational Drug to See How it Affects the People With Parkinson's Disease Complicated by Motor Fluctuations (\"OFF\" Episodes) Compared to an Approved Drug Used to Treat People With Parkinson's Disease Complicated by Motor Fluctuations (\"OFF\" Episodes)","Apomorphine","DS Agonist","No",null,"No",null,"Phase 3",2,106,"Anticipated","2018-10-24","2020-05-24",{"$nulls":5},"A study of an investigational drug to see how it affects the people with Parkinson's Disease complicated by motor fluctuations (\"OFF\" Episodes) compared to an approved drug used to treat people with Parkinson's Disease complicated by motor fluctuations (\"OFF\" Episodes)","An Open-Label, Randomized, Crossover Trial utilizing a Single-Blinded Rater to evaluate APL-130277 compared to s.c. Apomorphine in Levodopa Responsive Subjects with Parkinson's Disease Complicated by Motor Fluctuations.\n\nPART A consists of an open label, crossover titration phase where eligible subjects will be randomized to 1 of 2 treatment sequences in a 1:1 ratio to Sublingual APL 130277 followed by subcutaneous apomorphine or subcutaneous apomorphine followed by sublingual APL 130277. Subjects will undergo dose titration with the first study treatment (APL 130277 or sc apomorphine) to tolerance and effect, ie, the tolerable dose that turns the subject from the practically defined \"OFF\" state to the full \"ON\" state as determined by both the Investigator and subject. The subject will then be crossed over to the other study treatment (APL 130277 or subcutaneous apomorphine) and similarly titrated to tolerance and effect. These determined doses of APL 130277 and subcutaneous apomorphine will be used during PART B.\n\nPART B consists of an open-label, crossover treatment period where subjects will be randomized to one of the study treatment for 4 weeks, then be crossed over to the other study treatment (APL-130277 or sc apomorphine) for additional 4-weeks of open-label treatment. Subjects return to the clinic for safety and efficacy assessments throughout the treatment period.\n\nThis study is designed to test the superiority of sublingually administered APL-130277 against subcutaneously injected apomorphine (APO-go) for the treatment of \"OFF\" episodes in patients with Parkinson's Disease, as measured by the change from pre-dose to 90 minutes post-dose in MDS UPDRS Part III score in Part B after 4 weeks of dosing in each crossover period.","An Open-Label, Randomized, Crossover Trial Utilizing a Single-Blinded Rater to Evaluate APL-130277 Compared to Subcutaneous Apomorphine in Levodopa Responsive Subjects With Parkinson's Disease Complicated by Motor Fluctuations","CTH-302","Motor OFF Episodes Associated With Parkinson's Disease","Parkinson Disease","Central Nervous System Diseases","Central Nervous System","Experimental|Active Comparator","APL-130277|subcutaneous apomorphine","APL-130277: Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A|subcutaneous apomorphine , Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A","Drug","APL-130277|subcutaneous apomorphine","APL-130277: Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A|subcutaneous apomorphine Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A","Apomorphine Hydrochloride|APO-goÂ®","APL-130277|subcutaneous apomorphine","\n\n 1.  The subject (and caregiver, if applicable) must be fully informed of and understand the objectives, procedures, and possible benefits and risks of the study, and give written informed consent prior to performing any study related activities.\n 2.  Male or female â‰¥ 18 years of age.\n 3.  Clinical diagnosis of Idiopathic PD, consistent with UK Brain Bank Criteria (excluding the \"more than one affected relative\" criterion).\n 4.  Clinically meaningful response to levodopa (L-Dopa), as determined by the Investigator.\n 5.  Subjects at screening must demonstrate an adequate L-Dopa response on the MDS UPDRS Part III in the \"ON\" state compared to the MDS UPDRS Part III in the \"OFF\" state and on the Hoehn and Yahr, as determined during the review by Enrollment Adjudication Committee (EAC), Sponsor, and Medical Monitor.\n 6.  Receiving stable doses of L Dopa/carbidopa and/or L Dopa/benserazide and/or L Dopa/carbidopa/entacapone (immediate or chronic release) administered at least 4 times per day OR Rytaryâ„¢ administered at least 3 times per day for at least 4 weeks before the initial screening Visit (SV1). Adjunctive PD medication regimens are permitted but must be maintained at a stable dose for at least 4 weeks prior to SV1 with the exception of monoamine oxidase B (MAO B) inhibitors, which must be maintained at a stable level for at least 8 weeks prior to SV1.\n 7.  No planned medication change(s) or surgical intervention anticipated during the course of study.\n 8.  Subjects must experience at least one well defined \"OFF\" episode per day and have a total daily \"OFF\" time duration of > 2 hours during the waking day, based on judgment of physician and subject self assessment.\n 9.  Subject must have predictable morning \"OFF\" periods, based on judgment of physician and subject self assessment.\n 10. Subject, and where appropriate caregiver, must be trained in completing the home dosing diaries and able to recognize \"ON\" and \"OFF\" states.\n 11. Stage III or less on the modified Hoehn and Yahr scale in the \"ON\" state.\n 12. Mini-Mental State Examination (MMSE) score > 25.\n 13. Female subject of childbearing potential and male subject with female partner of childbearing potential must agree to either remain abstinent or use adequate and reliable contraception throughout the study and for at least 7 days after the last dose of study drug has been taken. Note: Continued use of adequate and reliable contraception is recommended through 30 days after study completion.\n 14. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study related procedures to complete the study.\n 15. Must be approved as a satisfactory candidate by the Enrollment Adjudication Committee (EAC), Medical Monitor, and Sponsor.\n\n","\n\n 1.  Atypical or secondary parkinsonism.\n 2.  Major focal brain disorders including malignancy or stroke.\n 3.  Prior treatment with any of the following: a neurosurgical procedure for PD; continuous subcutaneous (subcutaneous) apomorphine infusion; subcutaneous (subcutaneous) apomorphine injection; Duodopa/Duopa; or APL-130277.\n 4.  Contraindications to domperidone, subcutaneous apomorphine, or hypersensitivity to apomorphine hydrochloride or any of the ingredients of subcutaneous apomorphine (notably sodium metabisulfite).\n 5.  Female who is pregnant or lactating.\n 6.  Participation in an interventional clinical study and/or receipt of any investigational (ie, unapproved) medication within 30 days prior to SV1.\n 7.  Currently taking selective 5HT3 antagonists (ie, ondansetron, granisetron, dolasetron, palonosetron, alosetron), dopamine antagonists (excluding quetiapine or clozapine) or dopamine depleting agents. Subjects receiving anti depressants must be on a stable daily dose for at least 8 weeks prior to SV1.\n 8.  The subject has a current diagnosis or history of substance abuse (excluding nicotine and caffeine) or alcohol abuse (in the opinion of the investigator) < 6 months prior to SV1.\n 9.  The recreational use of cannabinoids and hallucinogenic are excluded, as well any use of a sublingual formulation of any drug.\n 10. Subject has a history of malignancy within 5 years prior to SV1, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.\n 11. Subject has a clinically significant abnormality on screening evaluation including physical examination, vital signs, electrocardiogram (ECG), or laboratory tests that the Investigator considers to be inappropriate to allow participation in the study.\n 12. Subject has screening laboratory test results of: blood urea nitrogen (BUN) value â‰¥ 1.5 times the upper limit of normal (ULN) for the reference range; serum creatinine > 1.5 times the ULN for the reference range; or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value â‰¥ 2 times the ULN for the reference laboratory.\n 13. Subject has random (non-fasting) screening glucose of â‰¥ 200 mg/dL (11.1 mmol/L) or HbA1c > 7.0%.\n 14. Subjects with type 1 diabetes, or insulin dependent diabetics are excluded. Subjects with type 2 diabetes are eligible for study inclusion if the following conditions are met: * Subject's screening glucose is < 200 mg/dL (11.1 mmol/L). Note: Subjects with random (non fasting) blood glucose at screening â‰¥ 200 mg/dL (11.1 mmol/L) must be retested in a fasted state; and\n      * Subject's hemoglobin A1c (HbA1c) â‰¤ 7.0%; and\n      * If the subject is currently being treated with oral anti-diabetic medication(s), the dose must have been stable for at least 4 weeks prior to SV1. Such medication may be adjusted or discontinued during the study, as clinically indicated.\n     \n     \n 15. The subject's screening ECG results of corrected QT interval using Fridericia's formula (QTcF) â‰¥ 450 msec for male subjects or â‰¥ 470 msec for female subjects. Eligibility will be based on the core laboratory ECG interpretation report.\n 16. Subject has a positive screening laboratory test result for human immunodeficiency virus (HIV).\n 17. Subject has a positive screening laboratory test result for hepatitis B surface antigen or hepatitis C antibodies and has liver function test results at screening above the ULN for the reference laboratory.\n 18. Subject has any other medical disorder that, in the opinion of the Investigator, could interfere with the subject's participation in the study.\n 19. Subject has major psychiatric disorder(s), including but not limited to: bipolar disorder, psychosis (eg, Parkinson's Disease Psychosis), major depressive episode, or any disorder that, in the opinion of the Investigator, would require treatment that could make study participation unsafe or make treatment compliance difficult.\n 20. History of clinically significant impulse control disorder(s).\n 21. History of symptomatic orthostatic hypotension requiring medication.\n 22. History of severe dyskinesia based on a score of 4 on the MDS-UPDRS Part IV.\n 23. Dementia that precludes providing informed consent or would interfere with participation in the study.\n 24. Current/recent suicidal ideation as evidenced by answering \"yes\" to \"Suicidal Ideation\" item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) on the C-SSRS assessment at screening (using the \"screening /Baseline Version\" scale, in the past 12 months) or attempted suicide within the last 5 years.\n 25. Presence of canker or mouth sores in the 30 days prior to SV1, or other clinically significant oral pathology in the opinion of the Investigator. The Investigator should follow-up with an appropriate specialist on any finding, if indicated, before enrolling a subject into the study","MAOB","monoamine oxidase B","Gene","Prostate","Actual","2018-01-05","Actual","Anticipated","2020-05-31","Anticipated","2018-11-01","2018-01-02","2018-01-02","2018-11-05","No","Parkinson's Disease\n\"Off\" Episodes\nmotor fluctuations associated with Parkinson's Disease","Interventional","Treatment","Crossover Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":4},"Yes",{"$nulls":12},"2016-003456-70","EudraCT Number","change from pre-dose to 90 minutes post-dose in MDS UPDRS Part III score after 4 weeks of dosing in each crossover period (assessed by the blinded-rater in-clinic at Visit 3 and Visit 6 of PART B).","Week 4",null,"Durability of effect, defined as an Investigator confirmed full \"ON\" within 30 minutes post dose and at 90 minutes post-dose, after 4 weeks of dosing in each crossover period (assessed by the blinded-rater in-clinic at Visit 3 and Visit 6 of PART B).|Subject preference for treatment regimen as measured by the Subject Preference Visual Analog Scale (VAS) after the subject has completed both APL 130277 and sc apomorphine treatment regimens (assessed in-clinic at Visit 6 of PART B).|Per the Expanded Home Dosing Diary, percent of \"ON\" episodes without troublesome dyskinesia based on the 3 consecutive days prior to Visit 2, Visit 3, Visit 5, and Visit 6.|Subject confirmed durability of effect, defined as subject confirmed full \"ON\" within 30 minutes post-dose and at 90 minutes post-dose, after 4 weeks of dosing in each crossover period (assessed in-clinic at Visit 3 and Visit 6 of PART B).|Patient Global Impression of Change (PGI-C): Subject improvement of \"OFF\" episodes, defined as very much better, much better or a little better after 4 weeks of dosing in each crossover period (assessed in-clinic at Visit 3 and Visit 6 of PART B).","Week 4|with a recorded range of -50 to 50. Negative values indicate preference for SC treatment, and the more negative the value, the stronger is the preference for SC compared to APL treatment. Positive values indicate preference for APL treatment, and the more positive the value, the stronger is the preference for APL compared to SC treatment. A value of 0 indicates no preference of one treatment over the other.","Week 4","clinicaltrialdisclousre@sunovion.com","CNS Medical Director","1-866-503-6351","Greater Manchester, United Kingdom, Bl9 7Td",null,"United Kingdom","Nhs Forth Valley, Pennine Actue Nhs Trust, Fairfield General Hospital",{"$nulls":3},"CNS Medical Director","2018-11-05","2020-05-25T16:35:25.976","2020-05-26T17:10:42.972","NCT03391882"]
["5ecbf3cd307e3d1b1f8d9c4b","NCT03391882","2018-12-10","Sunovion","SEPR","Recruiting","A Study of an Investigational Drug to See How it Affects the People With Parkinson's Disease Complicated by Motor Fluctuations (\"OFF\" Episodes) Compared to an Approved Drug Used to Treat People With Parkinson's Disease Complicated by Motor Fluctuations (\"OFF\" Episodes)","Apomorphine","DS Agonist","No",null,"No",null,"Phase 3",2,106,"Anticipated","2018-10-24","2020-05-24",{"$nulls":5},"A study of an investigational drug to see how it affects the people with Parkinson's Disease complicated by motor fluctuations (\"OFF\" Episodes) compared to an approved drug used to treat people with Parkinson's Disease complicated by motor fluctuations (\"OFF\" Episodes)","An Open-Label, Randomized, Crossover Trial utilizing a Single-Blinded Rater to evaluate APL-130277 compared to s.c. Apomorphine in Levodopa Responsive Subjects with Parkinson's Disease Complicated by Motor Fluctuations.\n\nPART A consists of an open label, crossover titration phase where eligible subjects will be randomized to 1 of 2 treatment sequences in a 1:1 ratio to Sublingual APL 130277 followed by subcutaneous apomorphine or subcutaneous apomorphine followed by sublingual APL 130277. Subjects will undergo dose titration with the first study treatment (APL 130277 or sc apomorphine) to tolerance and effect, ie, the tolerable dose that turns the subject from the practically defined \"OFF\" state to the full \"ON\" state as determined by both the Investigator and subject. The subject will then be crossed over to the other study treatment (APL 130277 or subcutaneous apomorphine) and similarly titrated to tolerance and effect. These determined doses of APL 130277 and subcutaneous apomorphine will be used during PART B.\n\nPART B consists of an open-label, crossover treatment period where subjects will be randomized to one of the study treatment for 4 weeks, then be crossed over to the other study treatment (APL-130277 or sc apomorphine) for additional 4-weeks of open-label treatment. Subjects return to the clinic for safety and efficacy assessments throughout the treatment period.\n\nThis study is designed to test the superiority of sublingually administered APL-130277 against subcutaneously injected apomorphine (APO-go) for the treatment of \"OFF\" episodes in patients with Parkinson's Disease, as measured by the change from pre-dose to 90 minutes post-dose in MDS UPDRS Part III score in Part B after 4 weeks of dosing in each crossover period.","An Open-Label, Randomized, Crossover Trial Utilizing a Single-Blinded Rater to Evaluate APL-130277 Compared to Subcutaneous Apomorphine in Levodopa Responsive Subjects With Parkinson's Disease Complicated by Motor Fluctuations","CTH-302","Motor OFF Episodes Associated With Parkinson's Disease","Parkinson Disease","Central Nervous System Diseases","Central Nervous System","Experimental|Active Comparator","APL-130277|subcutaneous apomorphine","APL-130277: Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A|subcutaneous apomorphine , Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A","Drug","APL-130277|subcutaneous apomorphine","APL-130277: Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A|subcutaneous apomorphine Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A","Apomorphine Hydrochloride|APO-goÂ®","APL-130277|subcutaneous apomorphine","\n\n 1.  The subject (and caregiver, if applicable) must be fully informed of and understand the objectives, procedures, and possible benefits and risks of the study, and give written informed consent prior to performing any study related activities.\n 2.  Male or female â‰¥ 18 years of age.\n 3.  Clinical diagnosis of Idiopathic PD, consistent with UK Brain Bank Criteria (excluding the \"more than one affected relative\" criterion).\n 4.  Clinically meaningful response to levodopa (L-Dopa), as determined by the Investigator.\n 5.  Subjects at screening must demonstrate an adequate L-Dopa response on the MDS UPDRS Part III in the \"ON\" state compared to the MDS UPDRS Part III in the \"OFF\" state and on the Hoehn and Yahr, as determined during the review by Enrollment Adjudication Committee (EAC), Sponsor, and Medical Monitor.\n 6.  Receiving stable doses of L Dopa/carbidopa and/or L Dopa/benserazide and/or L Dopa/carbidopa/entacapone (immediate or chronic release) administered at least 4 times per day OR Rytaryâ„¢ administered at least 3 times per day for at least 4 weeks before the initial screening Visit (SV1). Adjunctive PD medication regimens are permitted but must be maintained at a stable dose for at least 4 weeks prior to SV1 with the exception of monoamine oxidase B (MAO B) inhibitors, which must be maintained at a stable level for at least 8 weeks prior to SV1.\n 7.  No planned medication change(s) or surgical intervention anticipated during the course of study.\n 8.  Subjects must experience at least one well defined \"OFF\" episode per day and have a total daily \"OFF\" time duration of > 2 hours during the waking day, based on judgment of physician and subject self assessment.\n 9.  Subject must have predictable morning \"OFF\" periods, based on judgment of physician and subject self assessment.\n 10. Subject, and where appropriate caregiver, must be trained in completing the home dosing diaries and able to recognize \"ON\" and \"OFF\" states.\n 11. Stage III or less on the modified Hoehn and Yahr scale in the \"ON\" state.\n 12. Mini-Mental State Examination (MMSE) score > 25.\n 13. Female subject of childbearing potential and male subject with female partner of childbearing potential must agree to either remain abstinent or use adequate and reliable contraception throughout the study and for at least 7 days after the last dose of study drug has been taken. Note: Continued use of adequate and reliable contraception is recommended through 30 days after study completion.\n 14. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study related procedures to complete the study.\n 15. Must be approved as a satisfactory candidate by the Enrollment Adjudication Committee (EAC), Medical Monitor, and Sponsor.\n\n","\n\n 1.  Atypical or secondary parkinsonism.\n 2.  Major focal brain disorders including malignancy or stroke.\n 3.  Prior treatment with any of the following: a neurosurgical procedure for PD; continuous subcutaneous (subcutaneous) apomorphine infusion; subcutaneous (subcutaneous) apomorphine injection; Duodopa/Duopa; or APL-130277.\n 4.  Contraindications to domperidone, subcutaneous apomorphine, or hypersensitivity to apomorphine hydrochloride or any of the ingredients of subcutaneous apomorphine (notably sodium metabisulfite).\n 5.  Female who is pregnant or lactating.\n 6.  Participation in an interventional clinical study and/or receipt of any investigational (ie, unapproved) medication within 30 days prior to SV1.\n 7.  Currently taking selective 5HT3 antagonists (ie, ondansetron, granisetron, dolasetron, palonosetron, alosetron), dopamine antagonists (excluding quetiapine or clozapine) or dopamine depleting agents. Subjects receiving anti depressants must be on a stable daily dose for at least 8 weeks prior to SV1.\n 8.  The subject has a current diagnosis or history of substance abuse (excluding nicotine and caffeine) or alcohol abuse (in the opinion of the investigator) < 6 months prior to SV1.\n 9.  The recreational use of cannabinoids and hallucinogenic are excluded, as well any use of a sublingual formulation of any drug.\n 10. Subject has a history of malignancy within 5 years prior to SV1, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.\n 11. Subject has a clinically significant abnormality on screening evaluation including physical examination, vital signs, electrocardiogram (ECG), or laboratory tests that the Investigator considers to be inappropriate to allow participation in the study.\n 12. Subject has screening laboratory test results of: blood urea nitrogen (BUN) value â‰¥ 1.5 times the upper limit of normal (ULN) for the reference range; serum creatinine > 1.5 times the ULN for the reference range; or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value â‰¥ 2 times the ULN for the reference laboratory.\n 13. Subject has random (non-fasting) screening glucose of â‰¥ 200 mg/dL (11.1 mmol/L) or HbA1c > 7.0%.\n 14. Subjects with type 1 diabetes, or insulin dependent diabetics are excluded. Subjects with type 2 diabetes are eligible for study inclusion if the following conditions are met: * Subject's screening glucose is < 200 mg/dL (11.1 mmol/L). Note: Subjects with random (non fasting) blood glucose at screening â‰¥ 200 mg/dL (11.1 mmol/L) must be retested in a fasted state; and\n      * Subject's hemoglobin A1c (HbA1c) â‰¤ 7.0%; and\n      * If the subject is currently being treated with oral anti-diabetic medication(s), the dose must have been stable for at least 4 weeks prior to SV1. Such medication may be adjusted or discontinued during the study, as clinically indicated.\n     \n     \n 15. The subject's screening ECG results of corrected QT interval using Fridericia's formula (QTcF) â‰¥ 450 msec for male subjects or â‰¥ 470 msec for female subjects. Eligibility will be based on the core laboratory ECG interpretation report.\n 16. Subject has a positive screening laboratory test result for human immunodeficiency virus (HIV).\n 17. Subject has a positive screening laboratory test result for hepatitis B surface antigen or hepatitis C antibodies and has liver function test results at screening above the ULN for the reference laboratory.\n 18. Subject has any other medical disorder that, in the opinion of the Investigator, could interfere with the subject's participation in the study.\n 19. Subject has major psychiatric disorder(s), including but not limited to: bipolar disorder, psychosis (eg, Parkinson's Disease Psychosis), major depressive episode, or any disorder that, in the opinion of the Investigator, would require treatment that could make study participation unsafe or make treatment compliance difficult.\n 20. History of clinically significant impulse control disorder(s).\n 21. History of symptomatic orthostatic hypotension requiring medication.\n 22. History of severe dyskinesia based on a score of 4 on the MDS-UPDRS Part IV.\n 23. Dementia that precludes providing informed consent or would interfere with participation in the study.\n 24. Current/recent suicidal ideation as evidenced by answering \"yes\" to \"Suicidal Ideation\" item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) on the C-SSRS assessment at screening (using the \"screening /Baseline Version\" scale, in the past 12 months) or attempted suicide within the last 5 years.\n 25. Presence of canker or mouth sores in the 30 days prior to SV1, or other clinically significant oral pathology in the opinion of the Investigator. The Investigator should follow-up with an appropriate specialist on any finding, if indicated, before enrolling a subject into the study","MAOB","monoamine oxidase B","Gene","Prostate","Actual","2018-01-05","Actual","Anticipated","2020-05-31","Anticipated","2018-12-01","2018-01-02","2018-01-02","2018-12-07","No","Parkinson's Disease\n\"Off\" Episodes\nmotor fluctuations associated with Parkinson's Disease","Interventional","Treatment","Crossover Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":4},"Yes",{"$nulls":12},"2016-003456-70","EudraCT Number","change from pre-dose to 90 minutes post-dose in MDS UPDRS Part III score after 4 weeks of dosing in each crossover period (assessed by the blinded-rater in-clinic at Visit 3 and Visit 6 of PART B).","Week 4",null,"Durability of effect, defined as an Investigator confirmed full \"ON\" within 30 minutes post dose and at 90 minutes post-dose, after 4 weeks of dosing in each crossover period (assessed by the blinded-rater in-clinic at Visit 3 and Visit 6 of PART B).|Subject preference for treatment regimen as measured by the Subject Preference Visual Analog Scale (VAS) after the subject has completed both APL 130277 and sc apomorphine treatment regimens (assessed in-clinic at Visit 6 of PART B).|Per the Expanded Home Dosing Diary, percent of \"ON\" episodes without troublesome dyskinesia based on the 3 consecutive days prior to Visit 2, Visit 3, Visit 5, and Visit 6.|Subject confirmed durability of effect, defined as subject confirmed full \"ON\" within 30 minutes post-dose and at 90 minutes post-dose, after 4 weeks of dosing in each crossover period (assessed in-clinic at Visit 3 and Visit 6 of PART B).|Patient Global Impression of Change (PGI-C): Subject improvement of \"OFF\" episodes, defined as very much better, much better or a little better after 4 weeks of dosing in each crossover period (assessed in-clinic at Visit 3 and Visit 6 of PART B).","Week 4|with a recorded range of -50 to 50. Negative values indicate preference for SC treatment, and the more negative the value, the stronger is the preference for SC compared to APL treatment. Positive values indicate preference for APL treatment, and the more positive the value, the stronger is the preference for APL compared to SC treatment. A value of 0 indicates no preference of one treatment over the other.","Week 4","clinicaltrialdisclousre@sunovion.com","CNS Medical Director","1-866-503-6351","Haag In Oberbayern, Germany, 83527|Sant Cugat Del Valles, Spain, 08195|Manchester, United Kingdom, Bl9 7Td",null,"Germany|Spain|United Kingdom","Klinik Haag I.Ob|Hospital General De Catalunya|Nhs Forth Valley, Pennine Actue Nhs Trust, Fairfield General Hospital",{"$nulls":3},"CNS Medical Director","2018-12-07","2020-05-25T16:35:25.941","2020-05-26T17:10:42.972","NCT03391882"]
["5ecbf3cee2561b1b11905cb8","NCT03391882","2018-12-20","Sunovion","SEPR","Recruiting","A Study of an Investigational Drug to See How it Affects the People With Parkinson's Disease Complicated by Motor Fluctuations (\"OFF\" Episodes) Compared to an Approved Drug Used to Treat People With Parkinson's Disease Complicated by Motor Fluctuations (\"OFF\" Episodes)","Apomorphine","DS Agonist","No",null,"No",null,"Phase 3",2,106,"Anticipated","2018-10-24","2020-05-24",{"$nulls":5},"A study of an investigational drug to see how it affects the people with Parkinson's Disease complicated by motor fluctuations (\"OFF\" Episodes) compared to an approved drug used to treat people with Parkinson's Disease complicated by motor fluctuations (\"OFF\" Episodes)","An Open-Label, Randomized, Crossover Trial utilizing a Single-Blinded Rater to evaluate APL-130277 compared to s.c. Apomorphine in Levodopa Responsive Subjects with Parkinson's Disease Complicated by Motor Fluctuations.\n\nPART A consists of an open label, crossover titration phase where eligible subjects will be randomized to 1 of 2 treatment sequences in a 1:1 ratio to Sublingual APL 130277 followed by subcutaneous apomorphine or subcutaneous apomorphine followed by sublingual APL 130277. Subjects will undergo dose titration with the first study treatment (APL 130277 or sc apomorphine) to tolerance and effect, ie, the tolerable dose that turns the subject from the practically defined \"OFF\" state to the full \"ON\" state as determined by both the Investigator and subject. The subject will then be crossed over to the other study treatment (APL 130277 or subcutaneous apomorphine) and similarly titrated to tolerance and effect. These determined doses of APL 130277 and subcutaneous apomorphine will be used during PART B.\n\nPART B consists of an open-label, crossover treatment period where subjects will be randomized to one of the study treatment for 4 weeks, then be crossed over to the other study treatment (APL-130277 or sc apomorphine) for additional 4-weeks of open-label treatment. Subjects return to the clinic for safety and efficacy assessments throughout the treatment period.\n\nThis study is designed to test the superiority of sublingually administered APL-130277 against subcutaneously injected apomorphine (APO-go) for the treatment of \"OFF\" episodes in patients with Parkinson's Disease, as measured by the change from pre-dose to 90 minutes post-dose in MDS UPDRS Part III score in Part B after 4 weeks of dosing in each crossover period.","An Open-Label, Randomized, Crossover Trial Utilizing a Single-Blinded Rater to Evaluate APL-130277 Compared to Subcutaneous Apomorphine in Levodopa Responsive Subjects With Parkinson's Disease Complicated by Motor Fluctuations","CTH-302","Motor OFF Episodes Associated With Parkinson's Disease","Parkinson Disease","Central Nervous System Diseases","Central Nervous System","Experimental|Active Comparator","APL-130277|subcutaneous apomorphine","APL-130277: Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A|subcutaneous apomorphine , Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A","Drug","APL-130277|subcutaneous apomorphine","APL-130277: Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A|subcutaneous apomorphine Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A","Apomorphine Hydrochloride|APO-goÂ®","APL-130277|subcutaneous apomorphine","\n\n 1.  The subject (and caregiver, if applicable) must be fully informed of and understand the objectives, procedures, and possible benefits and risks of the study, and give written informed consent prior to performing any study related activities.\n 2.  Male or female â‰¥ 18 years of age.\n 3.  Clinical diagnosis of Idiopathic PD, consistent with UK Brain Bank Criteria (excluding the \"more than one affected relative\" criterion).\n 4.  Clinically meaningful response to levodopa (L-Dopa), as determined by the Investigator.\n 5.  Subjects at screening must demonstrate an adequate L-Dopa response on the MDS UPDRS Part III in the \"ON\" state compared to the MDS UPDRS Part III in the \"OFF\" state and on the Hoehn and Yahr, as determined during the review by Enrollment Adjudication Committee (EAC), Sponsor, and Medical Monitor.\n 6.  Receiving stable doses of L Dopa/carbidopa and/or L Dopa/benserazide and/or L Dopa/carbidopa/entacapone (immediate or chronic release) administered at least 4 times per day OR Rytaryâ„¢ administered at least 3 times per day for at least 4 weeks before the initial screening Visit (SV1). Adjunctive PD medication regimens are permitted but must be maintained at a stable dose for at least 4 weeks prior to SV1 with the exception of monoamine oxidase B (MAO B) inhibitors, which must be maintained at a stable level for at least 8 weeks prior to SV1.\n 7.  No planned medication change(s) or surgical intervention anticipated during the course of study.\n 8.  Subjects must experience at least one well defined \"OFF\" episode per day and have a total daily \"OFF\" time duration of > 2 hours during the waking day, based on judgment of physician and subject self assessment.\n 9.  Subject must have predictable morning \"OFF\" periods, based on judgment of physician and subject self assessment.\n 10. Subject, and where appropriate caregiver, must be trained in completing the home dosing diaries and able to recognize \"ON\" and \"OFF\" states.\n 11. Stage III or less on the modified Hoehn and Yahr scale in the \"ON\" state.\n 12. Mini-Mental State Examination (MMSE) score > 25.\n 13. Female subject of childbearing potential and male subject with female partner of childbearing potential must agree to either remain abstinent or use adequate and reliable contraception throughout the study and for at least 7 days after the last dose of study drug has been taken. Note: Continued use of adequate and reliable contraception is recommended through 30 days after study completion.\n 14. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study related procedures to complete the study.\n 15. Must be approved as a satisfactory candidate by the Enrollment Adjudication Committee (EAC), Medical Monitor, and Sponsor.\n\n","\n\n 1.  Atypical or secondary parkinsonism.\n 2.  Major focal brain disorders including malignancy or stroke.\n 3.  Prior treatment with any of the following: a neurosurgical procedure for PD; continuous subcutaneous (subcutaneous) apomorphine infusion; subcutaneous (subcutaneous) apomorphine injection; Duodopa/Duopa; or APL-130277.\n 4.  Contraindications to domperidone, subcutaneous apomorphine, or hypersensitivity to apomorphine hydrochloride or any of the ingredients of subcutaneous apomorphine (notably sodium metabisulfite).\n 5.  Female who is pregnant or lactating.\n 6.  Participation in an interventional clinical study and/or receipt of any investigational (ie, unapproved) medication within 30 days prior to SV1.\n 7.  Currently taking selective 5HT3 antagonists (ie, ondansetron, granisetron, dolasetron, palonosetron, alosetron), dopamine antagonists (excluding quetiapine or clozapine) or dopamine depleting agents. Subjects receiving anti depressants must be on a stable daily dose for at least 8 weeks prior to SV1.\n 8.  The subject has a current diagnosis or history of substance abuse (excluding nicotine and caffeine) or alcohol abuse (in the opinion of the investigator) < 6 months prior to SV1.\n 9.  The recreational use of cannabinoids and hallucinogenic are excluded, as well any use of a sublingual formulation of any drug.\n 10. Subject has a history of malignancy within 5 years prior to SV1, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.\n 11. Subject has a clinically significant abnormality on screening evaluation including physical examination, vital signs, electrocardiogram (ECG), or laboratory tests that the Investigator considers to be inappropriate to allow participation in the study.\n 12. Subject has screening laboratory test results of: blood urea nitrogen (BUN) value â‰¥ 1.5 times the upper limit of normal (ULN) for the reference range; serum creatinine > 1.5 times the ULN for the reference range; or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value â‰¥ 2 times the ULN for the reference laboratory.\n 13. Subject has random (non-fasting) screening glucose of â‰¥ 200 mg/dL (11.1 mmol/L) or HbA1c > 7.0%.\n 14. Subjects with type 1 diabetes, or insulin dependent diabetics are excluded. Subjects with type 2 diabetes are eligible for study inclusion if the following conditions are met: * Subject's screening glucose is < 200 mg/dL (11.1 mmol/L). Note: Subjects with random (non fasting) blood glucose at screening â‰¥ 200 mg/dL (11.1 mmol/L) must be retested in a fasted state; and\n      * Subject's hemoglobin A1c (HbA1c) â‰¤ 7.0%; and\n      * If the subject is currently being treated with oral anti-diabetic medication(s), the dose must have been stable for at least 4 weeks prior to SV1. Such medication may be adjusted or discontinued during the study, as clinically indicated.\n     \n     \n 15. The subject's screening ECG results of corrected QT interval using Fridericia's formula (QTcF) â‰¥ 450 msec for male subjects or â‰¥ 470 msec for female subjects. Eligibility will be based on the core laboratory ECG interpretation report.\n 16. Subject has a positive screening laboratory test result for human immunodeficiency virus (HIV).\n 17. Subject has a positive screening laboratory test result for hepatitis B surface antigen or hepatitis C antibodies and has liver function test results at screening above the ULN for the reference laboratory.\n 18. Subject has any other medical disorder that, in the opinion of the Investigator, could interfere with the subject's participation in the study.\n 19. Subject has major psychiatric disorder(s), including but not limited to: bipolar disorder, psychosis (eg, Parkinson's Disease Psychosis), major depressive episode, or any disorder that, in the opinion of the Investigator, would require treatment that could make study participation unsafe or make treatment compliance difficult.\n 20. History of clinically significant impulse control disorder(s).\n 21. History of symptomatic orthostatic hypotension requiring medication.\n 22. History of severe dyskinesia based on a score of 4 on the MDS-UPDRS Part IV.\n 23. Dementia that precludes providing informed consent or would interfere with participation in the study.\n 24. Current/recent suicidal ideation as evidenced by answering \"yes\" to \"Suicidal Ideation\" item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) on the C-SSRS assessment at screening (using the \"screening /Baseline Version\" scale, in the past 12 months) or attempted suicide within the last 5 years.\n 25. Presence of canker or mouth sores in the 30 days prior to SV1, or other clinically significant oral pathology in the opinion of the Investigator. The Investigator should follow-up with an appropriate specialist on any finding, if indicated, before enrolling a subject into the study","MAOB","monoamine oxidase B","Gene","Prostate","Actual","2018-01-05","Actual","Anticipated","2020-05-31","Anticipated","2018-12-01","2018-01-02","2018-01-02","2018-12-18","No","Parkinson's Disease\n\"Off\" Episodes\nmotor fluctuations associated with Parkinson's Disease","Interventional","Treatment","Crossover Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":4},"Yes",{"$nulls":12},"2016-003456-70","EudraCT Number","change from pre-dose to 90 minutes post-dose in MDS UPDRS Part III score after 4 weeks of dosing in each crossover period (assessed by the blinded-rater in-clinic at Visit 3 and Visit 6 of PART B).","Week 4",null,"Durability of effect, defined as an Investigator confirmed full \"ON\" within 30 minutes post dose and at 90 minutes post-dose, after 4 weeks of dosing in each crossover period (assessed by the blinded-rater in-clinic at Visit 3 and Visit 6 of PART B).|Subject preference for treatment regimen as measured by the Subject Preference Visual Analog Scale (VAS) after the subject has completed both APL 130277 and sc apomorphine treatment regimens (assessed in-clinic at Visit 6 of PART B).|Per the Expanded Home Dosing Diary, percent of \"ON\" episodes without troublesome dyskinesia based on the 3 consecutive days prior to Visit 2, Visit 3, Visit 5, and Visit 6.|Subject confirmed durability of effect, defined as subject confirmed full \"ON\" within 30 minutes post-dose and at 90 minutes post-dose, after 4 weeks of dosing in each crossover period (assessed in-clinic at Visit 3 and Visit 6 of PART B).|Patient Global Impression of Change (PGI-C): Subject improvement of \"OFF\" episodes, defined as very much better, much better or a little better after 4 weeks of dosing in each crossover period (assessed in-clinic at Visit 3 and Visit 6 of PART B).","Week 4|with a recorded range of -50 to 50. Negative values indicate preference for SC treatment, and the more negative the value, the stronger is the preference for SC compared to APL treatment. Positive values indicate preference for APL treatment, and the more positive the value, the stronger is the preference for APL compared to SC treatment. A value of 0 indicates no preference of one treatment over the other.","Week 4","clinicaltrialdisclousre@sunovion.com","CNS Medical Director","1-866-503-6351","Marseille, France, 13385|Haag In Oberbayern, Germany, 83527|Sant Cugat Del Valles, Spain, 08195|Manchester, United Kingdom, Bl9 7Td",null,"France|Germany|Spain|United Kingdom","Hopital La Timone, Neurologie Et Pathologie Due Mouvement|Klinik Haag I.Ob|Hospital General De Catalunya|Nhs Forth Valley, Pennine Actue Nhs Trust, Fairfield General Hospital",{"$nulls":3},"CNS Medical Director","2018-12-18","2020-05-25T16:35:26.405","2020-05-26T17:10:42.972","NCT03391882"]
["5ecbf3ce307e3d1b1f8d9c4c","NCT03391882","2019-01-04","Sunovion","SEPR","Recruiting","A Study of an Investigational Drug to See How it Affects the People With Parkinson's Disease Complicated by Motor Fluctuations (\"OFF\" Episodes) Compared to an Approved Drug Used to Treat People With Parkinson's Disease Complicated by Motor Fluctuations (\"OFF\" Episodes)","Apomorphine","DS Agonist","No",null,"No",null,"Phase 3",2,106,"Anticipated","2018-10-24","2020-05-24",{"$nulls":5},"A study of an investigational drug to see how it affects the people with Parkinson's Disease complicated by motor fluctuations (\"OFF\" Episodes) compared to an approved drug used to treat people with Parkinson's Disease complicated by motor fluctuations (\"OFF\" Episodes)","An Open-Label, Randomized, Crossover Trial utilizing a Single-Blinded Rater to evaluate APL-130277 compared to s.c. Apomorphine in Levodopa Responsive Subjects with Parkinson's Disease Complicated by Motor Fluctuations.\n\nPART A consists of an open label, crossover titration phase where eligible subjects will be randomized to 1 of 2 treatment sequences in a 1:1 ratio to Sublingual APL 130277 followed by subcutaneous apomorphine or subcutaneous apomorphine followed by sublingual APL 130277. Subjects will undergo dose titration with the first study treatment (APL 130277 or sc apomorphine) to tolerance and effect, ie, the tolerable dose that turns the subject from the practically defined \"OFF\" state to the full \"ON\" state as determined by both the Investigator and subject. The subject will then be crossed over to the other study treatment (APL 130277 or subcutaneous apomorphine) and similarly titrated to tolerance and effect. These determined doses of APL 130277 and subcutaneous apomorphine will be used during PART B.\n\nPART B consists of an open-label, crossover treatment period where subjects will be randomized to one of the study treatment for 4 weeks, then be crossed over to the other study treatment (APL-130277 or sc apomorphine) for additional 4-weeks of open-label treatment. Subjects return to the clinic for safety and efficacy assessments throughout the treatment period.\n\nThis study is designed to test the superiority of sublingually administered APL-130277 against subcutaneously injected apomorphine (APO-go) for the treatment of \"OFF\" episodes in patients with Parkinson's Disease, as measured by the change from pre-dose to 90 minutes post-dose in MDS UPDRS Part III score in Part B after 4 weeks of dosing in each crossover period.","An Open-Label, Randomized, Crossover Trial Utilizing a Single-Blinded Rater to Evaluate APL-130277 Compared to Subcutaneous Apomorphine in Levodopa Responsive Subjects With Parkinson's Disease Complicated by Motor Fluctuations","CTH-302","Motor OFF Episodes Associated With Parkinson's Disease","Parkinson Disease","Central Nervous System Diseases","Central Nervous System","Experimental|Active Comparator","APL-130277|subcutaneous apomorphine","APL-130277: Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A|subcutaneous apomorphine , Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A","Drug","APL-130277|subcutaneous apomorphine","APL-130277: Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A|subcutaneous apomorphine Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A","Apomorphine Hydrochloride|APO-goÂ®","APL-130277|subcutaneous apomorphine","\n\n 1.  The subject (and caregiver, if applicable) must be fully informed of and understand the objectives, procedures, and possible benefits and risks of the study, and give written informed consent prior to performing any study related activities.\n 2.  Male or female â‰¥ 18 years of age.\n 3.  Clinical diagnosis of Idiopathic PD, consistent with UK Brain Bank Criteria (excluding the \"more than one affected relative\" criterion).\n 4.  Clinically meaningful response to levodopa (L-Dopa), as determined by the Investigator.\n 5.  Subjects at screening must demonstrate an adequate L-Dopa response on the MDS UPDRS Part III in the \"ON\" state compared to the MDS UPDRS Part III in the \"OFF\" state and on the Hoehn and Yahr, as determined during the review by Enrollment Adjudication Committee (EAC), Sponsor, and Medical Monitor.\n 6.  Receiving stable doses of L Dopa/carbidopa and/or L Dopa/benserazide and/or L Dopa/carbidopa/entacapone (immediate or chronic release) administered at least 4 times per day OR Rytaryâ„¢ administered at least 3 times per day for at least 4 weeks before the initial screening Visit (SV1). Adjunctive PD medication regimens are permitted but must be maintained at a stable dose for at least 4 weeks prior to SV1 with the exception of monoamine oxidase B (MAO B) inhibitors, which must be maintained at a stable level for at least 8 weeks prior to SV1.\n 7.  No planned medication change(s) or surgical intervention anticipated during the course of study.\n 8.  Subjects must experience at least one well defined \"OFF\" episode per day and have a total daily \"OFF\" time duration of > 2 hours during the waking day, based on judgment of physician and subject self assessment.\n 9.  Subject must have predictable morning \"OFF\" periods, based on judgment of physician and subject self assessment.\n 10. Subject, and where appropriate caregiver, must be trained in completing the home dosing diaries and able to recognize \"ON\" and \"OFF\" states.\n 11. Stage III or less on the modified Hoehn and Yahr scale in the \"ON\" state.\n 12. Mini-Mental State Examination (MMSE) score > 25.\n 13. Female subject of childbearing potential and male subject with female partner of childbearing potential must agree to either remain abstinent or use adequate and reliable contraception throughout the study and for at least 7 days after the last dose of study drug has been taken. Note: Continued use of adequate and reliable contraception is recommended through 30 days after study completion.\n 14. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study related procedures to complete the study.\n 15. Must be approved as a satisfactory candidate by the Enrollment Adjudication Committee (EAC), Medical Monitor, and Sponsor.\n\n","\n\n 1.  Atypical or secondary parkinsonism.\n 2.  Major focal brain disorders including malignancy or stroke.\n 3.  Prior treatment with any of the following: a neurosurgical procedure for PD; continuous subcutaneous (subcutaneous) apomorphine infusion; subcutaneous (subcutaneous) apomorphine injection; Duodopa/Duopa; or APL-130277.\n 4.  Contraindications to domperidone, subcutaneous apomorphine, or hypersensitivity to apomorphine hydrochloride or any of the ingredients of subcutaneous apomorphine (notably sodium metabisulfite).\n 5.  Female who is pregnant or lactating.\n 6.  Participation in an interventional clinical study and/or receipt of any investigational (ie, unapproved) medication within 30 days prior to SV1.\n 7.  Currently taking selective 5HT3 antagonists (ie, ondansetron, granisetron, dolasetron, palonosetron, alosetron), dopamine antagonists (excluding quetiapine or clozapine) or dopamine depleting agents. Subjects receiving anti depressants must be on a stable daily dose for at least 8 weeks prior to SV1.\n 8.  The subject has a current diagnosis or history of substance abuse (excluding nicotine and caffeine) or alcohol abuse (in the opinion of the investigator) < 6 months prior to SV1.\n 9.  The recreational use of cannabinoids and hallucinogenic are excluded, as well any use of a sublingual formulation of any drug.\n 10. Subject has a history of malignancy within 5 years prior to SV1, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.\n 11. Subject has a clinically significant abnormality on screening evaluation including physical examination, vital signs, electrocardiogram (ECG), or laboratory tests that the Investigator considers to be inappropriate to allow participation in the study.\n 12. Subject has screening laboratory test results of: blood urea nitrogen (BUN) value â‰¥ 1.5 times the upper limit of normal (ULN) for the reference range; serum creatinine > 1.5 times the ULN for the reference range; or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value â‰¥ 2 times the ULN for the reference laboratory.\n 13. Subject has random (non-fasting) screening glucose of â‰¥ 200 mg/dL (11.1 mmol/L) or HbA1c > 7.0%.\n 14. Subjects with type 1 diabetes, or insulin dependent diabetics are excluded. Subjects with type 2 diabetes are eligible for study inclusion if the following conditions are met: * Subject's screening glucose is < 200 mg/dL (11.1 mmol/L). Note: Subjects with random (non fasting) blood glucose at screening â‰¥ 200 mg/dL (11.1 mmol/L) must be retested in a fasted state; and\n      * Subject's hemoglobin A1c (HbA1c) â‰¤ 7.0%; and\n      * If the subject is currently being treated with oral anti-diabetic medication(s), the dose must have been stable for at least 4 weeks prior to SV1. Such medication may be adjusted or discontinued during the study, as clinically indicated.\n     \n     \n 15. The subject's screening ECG results of corrected QT interval using Fridericia's formula (QTcF) â‰¥ 450 msec for male subjects or â‰¥ 470 msec for female subjects. Eligibility will be based on the core laboratory ECG interpretation report.\n 16. Subject has a positive screening laboratory test result for human immunodeficiency virus (HIV).\n 17. Subject has a positive screening laboratory test result for hepatitis B surface antigen or hepatitis C antibodies and has liver function test results at screening above the ULN for the reference laboratory.\n 18. Subject has any other medical disorder that, in the opinion of the Investigator, could interfere with the subject's participation in the study.\n 19. Subject has major psychiatric disorder(s), including but not limited to: bipolar disorder, psychosis (eg, Parkinson's Disease Psychosis), major depressive episode, or any disorder that, in the opinion of the Investigator, would require treatment that could make study participation unsafe or make treatment compliance difficult.\n 20. History of clinically significant impulse control disorder(s).\n 21. History of symptomatic orthostatic hypotension requiring medication.\n 22. History of severe dyskinesia based on a score of 4 on the MDS-UPDRS Part IV.\n 23. Dementia that precludes providing informed consent or would interfere with participation in the study.\n 24. Current/recent suicidal ideation as evidenced by answering \"yes\" to \"Suicidal Ideation\" item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) on the C-SSRS assessment at screening (using the \"screening /Baseline Version\" scale, in the past 12 months) or attempted suicide within the last 5 years.\n 25. Presence of canker or mouth sores in the 30 days prior to SV1, or other clinically significant oral pathology in the opinion of the Investigator. The Investigator should follow-up with an appropriate specialist on any finding, if indicated, before enrolling a subject into the study","MAOB","monoamine oxidase B","Gene","Prostate","Actual","2018-01-05","Actual","Anticipated","2020-05-31","Anticipated","2019-01-01","2018-01-02","2018-01-02","2019-01-03","No","Parkinson's Disease\n\"Off\" Episodes\nmotor fluctuations associated with Parkinson's Disease","Interventional","Treatment","Crossover Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":4},"Yes",{"$nulls":12},"2016-003456-70","EudraCT Number","change from pre-dose to 90 minutes post-dose in MDS UPDRS Part III score after 4 weeks of dosing in each crossover period (assessed by the blinded-rater in-clinic at Visit 3 and Visit 6 of PART B).","Week 4",null,"Durability of effect, defined as an Investigator confirmed full \"ON\" within 30 minutes post dose and at 90 minutes post-dose, after 4 weeks of dosing in each crossover period (assessed by the blinded-rater in-clinic at Visit 3 and Visit 6 of PART B).|Subject preference for treatment regimen as measured by the Subject Preference Visual Analog Scale (VAS) after the subject has completed both APL 130277 and sc apomorphine treatment regimens (assessed in-clinic at Visit 6 of PART B).|Per the Expanded Home Dosing Diary, percent of \"ON\" episodes without troublesome dyskinesia based on the 3 consecutive days prior to Visit 2, Visit 3, Visit 5, and Visit 6.|Subject confirmed durability of effect, defined as subject confirmed full \"ON\" within 30 minutes post-dose and at 90 minutes post-dose, after 4 weeks of dosing in each crossover period (assessed in-clinic at Visit 3 and Visit 6 of PART B).|Patient Global Impression of Change (PGI-C): Subject improvement of \"OFF\" episodes, defined as very much better, much better or a little better after 4 weeks of dosing in each crossover period (assessed in-clinic at Visit 3 and Visit 6 of PART B).","Week 4|with a recorded range of -50 to 50. Negative values indicate preference for SC treatment, and the more negative the value, the stronger is the preference for SC compared to APL treatment. Positive values indicate preference for APL treatment, and the more positive the value, the stronger is the preference for APL compared to SC treatment. A value of 0 indicates no preference of one treatment over the other.","Week 4","clinicaltrialdisclousre@sunovion.com","CNS Medical Director","1-866-503-6351","Marseille, France, 13385|Haag In Oberbayern, Germany, 83527|Sant Cugat Del Valles, Spain, 08195|Manchester, United Kingdom, Bl9 7Td",null,"France|Germany|Spain|United Kingdom","Hopital La Timone, Neurologie Et Pathologie Due Mouvement|Klinik Haag I.Ob|Hospital General De Catalunya|Nhs Forth Valley, Pennine Actue Nhs Trust, Fairfield General Hospital",{"$nulls":3},"CNS Medical Director","2019-01-03","2020-05-25T16:35:26.110","2020-05-26T17:10:42.972","NCT03391882"]
["5ecbf3ce11702c1b1b9169cf","NCT03391882","2019-01-10","Sunovion","SEPR","Recruiting","A Study of an Investigational Drug to See How it Affects the People With Parkinson's Disease Complicated by Motor Fluctuations (\"OFF\" Episodes) Compared to an Approved Drug Used to Treat People With Parkinson's Disease Complicated by Motor Fluctuations (\"OFF\" Episodes)","Apomorphine","DS Agonist","No",null,"No",null,"Phase 3",2,106,"Anticipated","2018-10-24","2020-05-24",{"$nulls":5},"A study of an investigational drug to see how it affects the people with Parkinson's Disease complicated by motor fluctuations (\"OFF\" Episodes) compared to an approved drug used to treat people with Parkinson's Disease complicated by motor fluctuations (\"OFF\" Episodes)","An Open-Label, Randomized, Crossover Trial utilizing a Single-Blinded Rater to evaluate APL-130277 compared to s.c. Apomorphine in Levodopa Responsive Subjects with Parkinson's Disease Complicated by Motor Fluctuations.\n\nPART A consists of an open label, crossover titration phase where eligible subjects will be randomized to 1 of 2 treatment sequences in a 1:1 ratio to Sublingual APL 130277 followed by subcutaneous apomorphine or subcutaneous apomorphine followed by sublingual APL 130277. Subjects will undergo dose titration with the first study treatment (APL 130277 or sc apomorphine) to tolerance and effect, ie, the tolerable dose that turns the subject from the practically defined \"OFF\" state to the full \"ON\" state as determined by both the Investigator and subject. The subject will then be crossed over to the other study treatment (APL 130277 or subcutaneous apomorphine) and similarly titrated to tolerance and effect. These determined doses of APL 130277 and subcutaneous apomorphine will be used during PART B.\n\nPART B consists of an open-label, crossover treatment period where subjects will be randomized to one of the study treatment for 4 weeks, then be crossed over to the other study treatment (APL-130277 or sc apomorphine) for additional 4-weeks of open-label treatment. Subjects return to the clinic for safety and efficacy assessments throughout the treatment period.\n\nThis study is designed to test the superiority of sublingually administered APL-130277 against subcutaneously injected apomorphine (APO-go) for the treatment of \"OFF\" episodes in patients with Parkinson's Disease, as measured by the change from pre-dose to 90 minutes post-dose in MDS UPDRS Part III score in Part B after 4 weeks of dosing in each crossover period.","An Open-Label, Randomized, Crossover Trial Utilizing a Single-Blinded Rater to Evaluate APL-130277 Compared to Subcutaneous Apomorphine in Levodopa Responsive Subjects With Parkinson's Disease Complicated by Motor Fluctuations","CTH-302","Motor OFF Episodes Associated With Parkinson's Disease","Parkinson Disease","Central Nervous System Diseases","Central Nervous System","Experimental|Active Comparator","APL-130277|subcutaneous apomorphine","APL-130277: Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A|subcutaneous apomorphine , Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A","Drug","APL-130277|subcutaneous apomorphine","APL-130277: Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A|subcutaneous apomorphine Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A","Apomorphine Hydrochloride|APO-goÂ®","APL-130277|subcutaneous apomorphine","\n\n 1.  The subject (and caregiver, if applicable) must be fully informed of and understand the objectives, procedures, and possible benefits and risks of the study, and give written informed consent prior to performing any study related activities.\n 2.  Male or female â‰¥ 18 years of age.\n 3.  Clinical diagnosis of Idiopathic PD, consistent with UK Brain Bank Criteria (excluding the \"more than one affected relative\" criterion).\n 4.  Clinically meaningful response to levodopa (L-Dopa), as determined by the Investigator.\n 5.  Subjects at screening must demonstrate an adequate L-Dopa response on the MDS UPDRS Part III in the \"ON\" state compared to the MDS UPDRS Part III in the \"OFF\" state and on the Hoehn and Yahr, as determined during the review by Enrollment Adjudication Committee (EAC), Sponsor, and Medical Monitor.\n 6.  Receiving stable doses of L Dopa/carbidopa and/or L Dopa/benserazide and/or L Dopa/carbidopa/entacapone (immediate or chronic release) administered at least 4 times per day OR Rytaryâ„¢ administered at least 3 times per day for at least 4 weeks before the initial screening Visit (SV1). Adjunctive PD medication regimens are permitted but must be maintained at a stable dose for at least 4 weeks prior to SV1 with the exception of monoamine oxidase B (MAO B) inhibitors, which must be maintained at a stable level for at least 8 weeks prior to SV1.\n 7.  No planned medication change(s) or surgical intervention anticipated during the course of study.\n 8.  Subjects must experience at least one well defined \"OFF\" episode per day and have a total daily \"OFF\" time duration of > 2 hours during the waking day, based on judgment of physician and subject self assessment.\n 9.  Subject must have predictable morning \"OFF\" periods, based on judgment of physician and subject self assessment.\n 10. Subject, and where appropriate caregiver, must be trained in completing the home dosing diaries and able to recognize \"ON\" and \"OFF\" states.\n 11. Stage III or less on the modified Hoehn and Yahr scale in the \"ON\" state.\n 12. Mini-Mental State Examination (MMSE) score > 25.\n 13. Female subject of childbearing potential and male subject with female partner of childbearing potential must agree to either remain abstinent or use adequate and reliable contraception throughout the study and for at least 7 days after the last dose of study drug has been taken. Note: Continued use of adequate and reliable contraception is recommended through 30 days after study completion.\n 14. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study related procedures to complete the study.\n 15. Must be approved as a satisfactory candidate by the Enrollment Adjudication Committee (EAC), Medical Monitor, and Sponsor.\n\n","\n\n 1.  Atypical or secondary parkinsonism.\n 2.  Major focal brain disorders including malignancy or stroke.\n 3.  Prior treatment with any of the following: a neurosurgical procedure for PD; continuous subcutaneous (subcutaneous) apomorphine infusion; subcutaneous (subcutaneous) apomorphine injection; Duodopa/Duopa; or APL-130277.\n 4.  Contraindications to domperidone, subcutaneous apomorphine, or hypersensitivity to apomorphine hydrochloride or any of the ingredients of subcutaneous apomorphine (notably sodium metabisulfite).\n 5.  Female who is pregnant or lactating.\n 6.  Participation in an interventional clinical study and/or receipt of any investigational (ie, unapproved) medication within 30 days prior to SV1.\n 7.  Currently taking selective 5HT3 antagonists (ie, ondansetron, granisetron, dolasetron, palonosetron, alosetron), dopamine antagonists (excluding quetiapine or clozapine) or dopamine depleting agents. Subjects receiving anti depressants must be on a stable daily dose for at least 8 weeks prior to SV1.\n 8.  The subject has a current diagnosis or history of substance abuse (excluding nicotine and caffeine) or alcohol abuse (in the opinion of the investigator) < 6 months prior to SV1.\n 9.  The recreational use of cannabinoids and hallucinogenic are excluded, as well any use of a sublingual formulation of any drug.\n 10. Subject has a history of malignancy within 5 years prior to SV1, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.\n 11. Subject has a clinically significant abnormality on screening evaluation including physical examination, vital signs, electrocardiogram (ECG), or laboratory tests that the Investigator considers to be inappropriate to allow participation in the study.\n 12. Subject has screening laboratory test results of: blood urea nitrogen (BUN) value â‰¥ 1.5 times the upper limit of normal (ULN) for the reference range; serum creatinine > 1.5 times the ULN for the reference range; or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value â‰¥ 2 times the ULN for the reference laboratory.\n 13. Subject has random (non-fasting) screening glucose of â‰¥ 200 mg/dL (11.1 mmol/L) or HbA1c > 7.0%.\n 14. Subjects with type 1 diabetes, or insulin dependent diabetics are excluded. Subjects with type 2 diabetes are eligible for study inclusion if the following conditions are met: * Subject's screening glucose is < 200 mg/dL (11.1 mmol/L). Note: Subjects with random (non fasting) blood glucose at screening â‰¥ 200 mg/dL (11.1 mmol/L) must be retested in a fasted state; and\n      * Subject's hemoglobin A1c (HbA1c) â‰¤ 7.0%; and\n      * If the subject is currently being treated with oral anti-diabetic medication(s), the dose must have been stable for at least 4 weeks prior to SV1. Such medication may be adjusted or discontinued during the study, as clinically indicated.\n     \n     \n 15. The subject's screening ECG results of corrected QT interval using Fridericia's formula (QTcF) â‰¥ 450 msec for male subjects or â‰¥ 470 msec for female subjects. Eligibility will be based on the core laboratory ECG interpretation report.\n 16. Subject has a positive screening laboratory test result for human immunodeficiency virus (HIV).\n 17. Subject has a positive screening laboratory test result for hepatitis B surface antigen or hepatitis C antibodies and has liver function test results at screening above the ULN for the reference laboratory.\n 18. Subject has any other medical disorder that, in the opinion of the Investigator, could interfere with the subject's participation in the study.\n 19. Subject has major psychiatric disorder(s), including but not limited to: bipolar disorder, psychosis (eg, Parkinson's Disease Psychosis), major depressive episode, or any disorder that, in the opinion of the Investigator, would require treatment that could make study participation unsafe or make treatment compliance difficult.\n 20. History of clinically significant impulse control disorder(s).\n 21. History of symptomatic orthostatic hypotension requiring medication.\n 22. History of severe dyskinesia based on a score of 4 on the MDS-UPDRS Part IV.\n 23. Dementia that precludes providing informed consent or would interfere with participation in the study.\n 24. Current/recent suicidal ideation as evidenced by answering \"yes\" to \"Suicidal Ideation\" item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) on the C-SSRS assessment at screening (using the \"screening /Baseline Version\" scale, in the past 12 months) or attempted suicide within the last 5 years.\n 25. Presence of canker or mouth sores in the 30 days prior to SV1, or other clinically significant oral pathology in the opinion of the Investigator. The Investigator should follow-up with an appropriate specialist on any finding, if indicated, before enrolling a subject into the study","MAOB","monoamine oxidase B","Gene","Prostate","Actual","2018-01-05","Actual","Anticipated","2020-05-31","Anticipated","2019-01-01","2018-01-02","2018-01-02","2019-01-09","No","Parkinson's Disease\n\"Off\" Episodes\nmotor fluctuations associated with Parkinson's Disease","Interventional","Treatment","Crossover Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":4},"Yes",{"$nulls":12},"2016-003456-70","EudraCT Number","change from pre-dose to 90 minutes post-dose in MDS UPDRS Part III score after 4 weeks of dosing in each crossover period (assessed by the blinded-rater in-clinic at Visit 3 and Visit 6 of PART B).","Week 4",null,"Durability of effect, defined as an Investigator confirmed full \"ON\" within 30 minutes post dose and at 90 minutes post-dose, after 4 weeks of dosing in each crossover period (assessed by the blinded-rater in-clinic at Visit 3 and Visit 6 of PART B).|Subject preference for treatment regimen as measured by the Subject Preference Visual Analog Scale (VAS) after the subject has completed both APL 130277 and sc apomorphine treatment regimens (assessed in-clinic at Visit 6 of PART B).|Per the Expanded Home Dosing Diary, percent of \"ON\" episodes without troublesome dyskinesia based on the 3 consecutive days prior to Visit 2, Visit 3, Visit 5, and Visit 6.|Subject confirmed durability of effect, defined as subject confirmed full \"ON\" within 30 minutes post-dose and at 90 minutes post-dose, after 4 weeks of dosing in each crossover period (assessed in-clinic at Visit 3 and Visit 6 of PART B).|Patient Global Impression of Change (PGI-C): Subject improvement of \"OFF\" episodes, defined as very much better, much better or a little better after 4 weeks of dosing in each crossover period (assessed in-clinic at Visit 3 and Visit 6 of PART B).","Week 4|with a recorded range of -50 to 50. Negative values indicate preference for SC treatment, and the more negative the value, the stronger is the preference for SC compared to APL treatment. Positive values indicate preference for APL treatment, and the more positive the value, the stronger is the preference for APL compared to SC treatment. A value of 0 indicates no preference of one treatment over the other.","Week 4","clinicaltrialdisclousre@sunovion.com","CNS Medical Director","1-866-503-6351","Marseille, France, 13385|Haag In Oberbayern, Germany, 83527|Sant Cugat Del Valles, Spain, 08195|Manchester, United Kingdom, Bl9 7Td",null,"France|Germany|Spain|United Kingdom","Hopital La Timone, Neurologie Et Pathologie Due Mouvement|Klinik Haag I.Ob|Hospital General De Catalunya|Nhs Forth Valley, Pennine Actue Nhs Trust, Fairfield General Hospital",{"$nulls":3},"CNS Medical Director","2019-01-09","2020-05-25T16:35:26.129","2020-05-26T17:10:42.972","NCT03391882"]
["5ecbf3cefeab101b155307ec","NCT03391882","2019-01-11","Sunovion","SEPR","Recruiting","A Study of an Investigational Drug to See How it Affects the People With Parkinson's Disease Complicated by Motor Fluctuations (\"OFF\" Episodes) Compared to an Approved Drug Used to Treat People With Parkinson's Disease Complicated by Motor Fluctuations (\"OFF\" Episodes)","Apomorphine","DS Agonist","No",null,"No",null,"Phase 3",2,106,"Anticipated","2018-12-19","2020-05-24",{"$nulls":5},"A study of an investigational drug to see how it affects the people with Parkinson's Disease complicated by motor fluctuations (\"OFF\" Episodes) compared to an approved drug used to treat people with Parkinson's Disease complicated by motor fluctuations (\"OFF\" Episodes)","An Open-Label, Randomized, Crossover Trial utilizing a Single-Blinded Rater to evaluate APL-130277 compared to s.c. Apomorphine in Levodopa Responsive Subjects with Parkinson's Disease Complicated by Motor Fluctuations.\n\nPART A consists of an open label, crossover titration phase where eligible subjects will be randomized to 1 of 2 treatment sequences in a 1:1 ratio to Sublingual APL 130277 followed by subcutaneous apomorphine or subcutaneous apomorphine followed by sublingual APL 130277. Subjects will undergo dose titration with the first study treatment (APL 130277 or sc apomorphine) to tolerance and effect, ie, the tolerable dose that turns the subject from the practically defined \"OFF\" state to the full \"ON\" state as determined by both the Investigator and subject. The subject will then be crossed over to the other study treatment (APL 130277 or subcutaneous apomorphine) and similarly titrated to tolerance and effect. These determined doses of APL 130277 and subcutaneous apomorphine will be used during PART B.\n\nPART B consists of an open-label, crossover treatment period where subjects will be randomized to one of the study treatment for 4 weeks, then be crossed over to the other study treatment (APL-130277 or sc apomorphine) for additional 4-weeks of open-label treatment. Subjects return to the clinic for safety and efficacy assessments throughout the treatment period.\n\nThis study is designed to test the superiority of sublingually administered APL-130277 against subcutaneously injected apomorphine (APO-go) for the treatment of \"OFF\" episodes in patients with Parkinson's Disease, as measured by the change from pre-dose to 90 minutes post-dose in MDS UPDRS Part III score in Part B after 4 weeks of dosing in each crossover period.","An Open-Label, Randomized, Crossover Trial Utilizing a Single-Blinded Rater to Evaluate APL-130277 Compared to Subcutaneous Apomorphine in Levodopa Responsive Subjects With Parkinson's Disease Complicated by Motor Fluctuations","CTH-302","Motor OFF Episodes Associated With Parkinson's Disease","Parkinson Disease","Central Nervous System Diseases","Central Nervous System","Experimental|Active Comparator","APL-130277|subcutaneous apomorphine","APL-130277: Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A|subcutaneous apomorphine , Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A","Drug","APL-130277|subcutaneous apomorphine","APL-130277: Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A|subcutaneous apomorphine Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A","Apomorphine Hydrochloride|APO-goÂ®","APL-130277|subcutaneous apomorphine","\n\n 1.  The subject (and caregiver, if applicable) must be fully informed of and understand the objectives, procedures, and possible benefits and risks of the study, and give written informed consent prior to performing any study related activities.\n 2.  Male or female â‰¥ 18 years of age.\n 3.  Clinical diagnosis of Idiopathic PD, consistent with UK Brain Bank Criteria (excluding the \"more than one affected relative\" criterion).\n 4.  Clinically meaningful response to levodopa (L-Dopa), as determined by the Investigator.\n 5.  Subjects at screening must demonstrate an adequate L-Dopa response on the MDS UPDRS Part III in the \"ON\" state compared to the MDS UPDRS Part III in the \"OFF\" state and on the Hoehn and Yahr, as determined during the review by Enrollment Adjudication Committee (EAC), Sponsor, and Medical Monitor.\n 6.  Receiving stable doses of L Dopa/carbidopa and/or L Dopa/benserazide and/or L Dopa/carbidopa/entacapone (immediate or chronic release) administered at least 4 times per day OR Rytaryâ„¢ administered at least 3 times per day for at least 4 weeks before the initial screening Visit (SV1). Adjunctive PD medication regimens are permitted but must be maintained at a stable dose for at least 4 weeks prior to SV1 with the exception of monoamine oxidase B (MAO B) inhibitors, which must be maintained at a stable level for at least 8 weeks prior to SV1.\n 7.  No planned medication change(s) or surgical intervention anticipated during the course of study.\n 8.  Subjects must experience at least one well defined \"OFF\" episode per day and have a total daily \"OFF\" time duration of > 2 hours during the waking day, based on judgment of physician and subject self assessment.\n 9.  Subject must have predictable morning \"OFF\" periods, based on judgment of physician and subject self assessment.\n 10. Subject, and where appropriate caregiver, must be trained in completing the home dosing diaries and able to recognize \"ON\" and \"OFF\" states.\n 11. Stage III or less on the modified Hoehn and Yahr scale in the \"ON\" state.\n 12. Mini-Mental State Examination (MMSE) score > 25.\n 13. Female subject of childbearing potential and male subject with female partner of childbearing potential must agree to either remain abstinent or use adequate and reliable contraception throughout the study and for at least 7 days after the last dose of study drug has been taken. Note: Continued use of adequate and reliable contraception is recommended through 30 days after study completion.\n 14. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study related procedures to complete the study.\n 15. Must be approved as a satisfactory candidate by the Enrollment Adjudication Committee (EAC), Medical Monitor, and Sponsor.\n\n","\n\n 1.  Atypical or secondary parkinsonism.\n 2.  Major focal brain disorders including malignancy or stroke.\n 3.  Prior treatment with any of the following: a neurosurgical procedure for PD; continuous subcutaneous (subcutaneous) apomorphine infusion; subcutaneous (subcutaneous) apomorphine injection; Duodopa/Duopa; or APL-130277.\n 4.  Contraindications to domperidone, subcutaneous apomorphine, or hypersensitivity to apomorphine hydrochloride or any of the ingredients of subcutaneous apomorphine (notably sodium metabisulfite).\n 5.  Female who is pregnant or lactating.\n 6.  Participation in an interventional clinical study and/or receipt of any investigational (ie, unapproved) medication within 30 days prior to SV1.\n 7.  Currently taking selective 5HT3 antagonists (ie, ondansetron, granisetron, dolasetron, palonosetron, alosetron), dopamine antagonists (excluding quetiapine or clozapine) or dopamine depleting agents. Subjects receiving anti depressants must be on a stable daily dose for at least 8 weeks prior to SV1.\n 8.  The subject has a current diagnosis or history of substance abuse (excluding nicotine and caffeine) or alcohol abuse (in the opinion of the investigator) < 6 months prior to SV1.\n 9.  The recreational use of cannabinoids and hallucinogenic are excluded, as well any use of a sublingual formulation of any drug.\n 10. Subject has a history of malignancy within 5 years prior to SV1, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.\n 11. Subject has a clinically significant abnormality on screening evaluation including physical examination, vital signs, electrocardiogram (ECG), or laboratory tests that the Investigator considers to be inappropriate to allow participation in the study.\n 12. Subject has screening laboratory test results of: blood urea nitrogen (BUN) value â‰¥ 1.5 times the upper limit of normal (ULN) for the reference range; serum creatinine > 1.5 times the ULN for the reference range; or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value â‰¥ 2 times the ULN for the reference laboratory.\n 13. Subject has random (non-fasting) screening glucose of â‰¥ 200 mg/dL (11.1 mmol/L) or HbA1c > 7.0%.\n 14. Subjects with type 1 diabetes, or insulin dependent diabetics are excluded. Subjects with type 2 diabetes are eligible for study inclusion if the following conditions are met: * Subject's screening glucose is < 200 mg/dL (11.1 mmol/L). Note: Subjects with random (non fasting) blood glucose at screening â‰¥ 200 mg/dL (11.1 mmol/L) must be retested in a fasted state; and\n      * Subject's hemoglobin A1c (HbA1c) â‰¤ 7.0%; and\n      * If the subject is currently being treated with oral anti-diabetic medication(s), the dose must have been stable for at least 4 weeks prior to SV1. Such medication may be adjusted or discontinued during the study, as clinically indicated.\n     \n     \n 15. The subject's screening ECG results of corrected QT interval using Fridericia's formula (QTcF) â‰¥ 450 msec for male subjects or â‰¥ 470 msec for female subjects. Eligibility will be based on the core laboratory ECG interpretation report.\n 16. Subject has a positive screening laboratory test result for human immunodeficiency virus (HIV).\n 17. Subject has a positive screening laboratory test result for hepatitis B surface antigen or hepatitis C antibodies and has liver function test results at screening above the ULN for the reference laboratory.\n 18. Subject has any other medical disorder that, in the opinion of the Investigator, could interfere with the subject's participation in the study.\n 19. Subject has major psychiatric disorder(s), including but not limited to: bipolar disorder, psychosis (eg, Parkinson's Disease Psychosis), major depressive episode, or any disorder that, in the opinion of the Investigator, would require treatment that could make study participation unsafe or make treatment compliance difficult.\n 20. History of clinically significant impulse control disorder(s).\n 21. History of symptomatic orthostatic hypotension requiring medication.\n 22. History of severe dyskinesia based on a score of 4 on the MDS-UPDRS Part IV.\n 23. Dementia that precludes providing informed consent or would interfere with participation in the study.\n 24. Current/recent suicidal ideation as evidenced by answering \"yes\" to \"Suicidal Ideation\" item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) on the C-SSRS assessment at screening (using the \"screening /Baseline Version\" scale, in the past 12 months) or attempted suicide within the last 5 years.\n 25. Presence of canker or mouth sores in the 30 days prior to SV1, or other clinically significant oral pathology in the opinion of the Investigator. The Investigator should follow-up with an appropriate specialist on any finding, if indicated, before enrolling a subject into the study","MAOB","monoamine oxidase B","Gene","Prostate","Actual","2018-01-05","Actual","Anticipated","2020-05-31","Anticipated","2019-01-01","2018-01-02","2018-01-02","2019-01-10","No","Parkinson's Disease\n\"Off\" Episodes\nmotor fluctuations associated with Parkinson's Disease","Interventional","Treatment","Crossover Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":4},"Yes",{"$nulls":12},"2016-003456-70","EudraCT Number","change from pre-dose to 90 minutes post-dose in MDS UPDRS Part III score after 4 weeks of dosing in each crossover period (assessed by the blinded-rater in-clinic at Visit 3 and Visit 6 of PART B).","Week 4",null,"Durability of effect, defined as an Investigator confirmed full \"ON\" within 30 minutes post dose and at 90 minutes post-dose, after 4 weeks of dosing in each crossover period (assessed by the blinded-rater in-clinic at Visit 3 and Visit 6 of PART B).|Subject preference for treatment regimen as measured by the Subject Preference Visual Analog Scale (VAS) after the subject has completed both APL 130277 and sc apomorphine treatment regimens (assessed in-clinic at Visit 6 of PART B).|Per the Expanded Home Dosing Diary, percent of \"ON\" episodes without troublesome dyskinesia based on the 3 consecutive days prior to Visit 2, Visit 3, Visit 5, and Visit 6.|Subject confirmed durability of effect, defined as subject confirmed full \"ON\" within 30 minutes post-dose and at 90 minutes post-dose, after 4 weeks of dosing in each crossover period (assessed in-clinic at Visit 3 and Visit 6 of PART B).|Patient Global Impression of Change (PGI-C): Subject improvement of \"OFF\" episodes, defined as very much better, much better or a little better after 4 weeks of dosing in each crossover period (assessed in-clinic at Visit 3 and Visit 6 of PART B).","Week 4|with a recorded range of -50 to 50. Negative values indicate preference for SC treatment, and the more negative the value, the stronger is the preference for SC compared to APL treatment. Positive values indicate preference for APL treatment, and the more positive the value, the stronger is the preference for APL compared to SC treatment. A value of 0 indicates no preference of one treatment over the other.","Week 4","clinicaltrialdisclousre@sunovion.com","CNS Medical Director","1-866-503-6351","Marseille, France, 13385|Haag In Oberbayern, Germany, 83527|Sant Cugat Del Valles, Spain, 08195|London, United Kingdom, Se5 9Rs",null,"France|Germany|Spain|United Kingdom","Hopital La Timone, Neurologie Et Pathologie Due Mouvement|Klinik Haag I.Ob|Hospital General De Catalunya|King's College Hospital Nhs Foundation Trust",{"$nulls":3},"CNS Medical Director","2019-01-10","2020-05-25T16:35:26.353","2020-05-26T17:10:42.972","NCT03391882"]
["5ecbf3cefe30261b1a0481bd","NCT03391882","2019-01-16","Sunovion","SEPR","Recruiting","A Study of an Investigational Drug to See How it Affects the People With Parkinson's Disease Complicated by Motor Fluctuations (\"OFF\" Episodes) Compared to an Approved Drug Used to Treat People With Parkinson's Disease Complicated by Motor Fluctuations (\"OFF\" Episodes)","Apomorphine","DS Agonist","No",null,"No",null,"Phase 3",2,106,"Anticipated","2018-12-19","2020-05-24",{"$nulls":5},"A study of an investigational drug to see how it affects the people with Parkinson's Disease complicated by motor fluctuations (\"OFF\" Episodes) compared to an approved drug used to treat people with Parkinson's Disease complicated by motor fluctuations (\"OFF\" Episodes)","An Open-Label, Randomized, Crossover Trial utilizing a Single-Blinded Rater to evaluate APL-130277 compared to s.c. Apomorphine in Levodopa Responsive Subjects with Parkinson's Disease Complicated by Motor Fluctuations.\n\nPART A consists of an open label, crossover titration phase where eligible subjects will be randomized to 1 of 2 treatment sequences in a 1:1 ratio to Sublingual APL 130277 followed by subcutaneous apomorphine or subcutaneous apomorphine followed by sublingual APL 130277. Subjects will undergo dose titration with the first study treatment (APL 130277 or sc apomorphine) to tolerance and effect, ie, the tolerable dose that turns the subject from the practically defined \"OFF\" state to the full \"ON\" state as determined by both the Investigator and subject. The subject will then be crossed over to the other study treatment (APL 130277 or subcutaneous apomorphine) and similarly titrated to tolerance and effect. These determined doses of APL 130277 and subcutaneous apomorphine will be used during PART B.\n\nPART B consists of an open-label, crossover treatment period where subjects will be randomized to one of the study treatment for 4 weeks, then be crossed over to the other study treatment (APL-130277 or sc apomorphine) for additional 4-weeks of open-label treatment. Subjects return to the clinic for safety and efficacy assessments throughout the treatment period.\n\nThis study is designed to test the superiority of sublingually administered APL-130277 against subcutaneously injected apomorphine (APO-go) for the treatment of \"OFF\" episodes in patients with Parkinson's Disease, as measured by the change from pre-dose to 90 minutes post-dose in MDS UPDRS Part III score in Part B after 4 weeks of dosing in each crossover period.","An Open-Label, Randomized, Crossover Trial Utilizing a Single-Blinded Rater to Evaluate APL-130277 Compared to Subcutaneous Apomorphine in Levodopa Responsive Subjects With Parkinson's Disease Complicated by Motor Fluctuations","CTH-302","Motor OFF Episodes Associated With Parkinson's Disease","Parkinson Disease","Central Nervous System Diseases","Central Nervous System","Experimental|Active Comparator","APL-130277|subcutaneous apomorphine","APL-130277: Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A|subcutaneous apomorphine , Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A","Drug","APL-130277|subcutaneous apomorphine","APL-130277: Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A|subcutaneous apomorphine Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A","Apomorphine Hydrochloride|APO-goÂ®","APL-130277|subcutaneous apomorphine","\n\n 1.  The subject (and caregiver, if applicable) must be fully informed of and understand the objectives, procedures, and possible benefits and risks of the study, and give written informed consent prior to performing any study related activities.\n 2.  Male or female â‰¥ 18 years of age.\n 3.  Clinical diagnosis of Idiopathic PD, consistent with UK Brain Bank Criteria (excluding the \"more than one affected relative\" criterion).\n 4.  Clinically meaningful response to levodopa (L-Dopa), as determined by the Investigator.\n 5.  Subjects at screening must demonstrate an adequate L-Dopa response on the MDS UPDRS Part III in the \"ON\" state compared to the MDS UPDRS Part III in the \"OFF\" state and on the Hoehn and Yahr, as determined during the review by Enrollment Adjudication Committee (EAC), Sponsor, and Medical Monitor.\n 6.  Receiving stable doses of L Dopa/carbidopa and/or L Dopa/benserazide and/or L Dopa/carbidopa/entacapone (immediate or chronic release) administered at least 4 times per day OR Rytaryâ„¢ administered at least 3 times per day for at least 4 weeks before the initial screening Visit (SV1). Adjunctive PD medication regimens are permitted but must be maintained at a stable dose for at least 4 weeks prior to SV1 with the exception of monoamine oxidase B (MAO B) inhibitors, which must be maintained at a stable level for at least 8 weeks prior to SV1.\n 7.  No planned medication change(s) or surgical intervention anticipated during the course of study.\n 8.  Subjects must experience at least one well defined \"OFF\" episode per day and have a total daily \"OFF\" time duration of > 2 hours during the waking day, based on judgment of physician and subject self assessment.\n 9.  Subject must have predictable morning \"OFF\" periods, based on judgment of physician and subject self assessment.\n 10. Subject, and where appropriate caregiver, must be trained in completing the home dosing diaries and able to recognize \"ON\" and \"OFF\" states.\n 11. Stage III or less on the modified Hoehn and Yahr scale in the \"ON\" state.\n 12. Mini-Mental State Examination (MMSE) score > 25.\n 13. Female subject of childbearing potential and male subject with female partner of childbearing potential must agree to either remain abstinent or use adequate and reliable contraception throughout the study and for at least 7 days after the last dose of study drug has been taken. Note: Continued use of adequate and reliable contraception is recommended through 30 days after study completion.\n 14. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study related procedures to complete the study.\n 15. Must be approved as a satisfactory candidate by the Enrollment Adjudication Committee (EAC), Medical Monitor, and Sponsor.\n\n","\n\n 1.  Atypical or secondary parkinsonism.\n 2.  Major focal brain disorders including malignancy or stroke.\n 3.  Prior treatment with any of the following: a neurosurgical procedure for PD; continuous subcutaneous (subcutaneous) apomorphine infusion; subcutaneous (subcutaneous) apomorphine injection; Duodopa/Duopa; or APL-130277.\n 4.  Contraindications to domperidone, subcutaneous apomorphine, or hypersensitivity to apomorphine hydrochloride or any of the ingredients of subcutaneous apomorphine (notably sodium metabisulfite).\n 5.  Female who is pregnant or lactating.\n 6.  Participation in an interventional clinical study and/or receipt of any investigational (ie, unapproved) medication within 30 days prior to SV1.\n 7.  Currently taking selective 5HT3 antagonists (ie, ondansetron, granisetron, dolasetron, palonosetron, alosetron), dopamine antagonists (excluding quetiapine or clozapine) or dopamine depleting agents. Subjects receiving anti depressants must be on a stable daily dose for at least 8 weeks prior to SV1.\n 8.  The subject has a current diagnosis or history of substance abuse (excluding nicotine and caffeine) or alcohol abuse (in the opinion of the investigator) < 6 months prior to SV1.\n 9.  The recreational use of cannabinoids and hallucinogenic are excluded, as well any use of a sublingual formulation of any drug.\n 10. Subject has a history of malignancy within 5 years prior to SV1, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.\n 11. Subject has a clinically significant abnormality on screening evaluation including physical examination, vital signs, electrocardiogram (ECG), or laboratory tests that the Investigator considers to be inappropriate to allow participation in the study.\n 12. Subject has screening laboratory test results of: blood urea nitrogen (BUN) value â‰¥ 1.5 times the upper limit of normal (ULN) for the reference range; serum creatinine > 1.5 times the ULN for the reference range; or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value â‰¥ 2 times the ULN for the reference laboratory.\n 13. Subject has random (non-fasting) screening glucose of â‰¥ 200 mg/dL (11.1 mmol/L) or HbA1c > 7.0%.\n 14. Subjects with type 1 diabetes, or insulin dependent diabetics are excluded. Subjects with type 2 diabetes are eligible for study inclusion if the following conditions are met: * Subject's screening glucose is < 200 mg/dL (11.1 mmol/L). Note: Subjects with random (non fasting) blood glucose at screening â‰¥ 200 mg/dL (11.1 mmol/L) must be retested in a fasted state; and\n      * Subject's hemoglobin A1c (HbA1c) â‰¤ 7.0%; and\n      * If the subject is currently being treated with oral anti-diabetic medication(s), the dose must have been stable for at least 4 weeks prior to SV1. Such medication may be adjusted or discontinued during the study, as clinically indicated.\n     \n     \n 15. The subject's screening ECG results of corrected QT interval using Fridericia's formula (QTcF) â‰¥ 450 msec for male subjects or â‰¥ 470 msec for female subjects. Eligibility will be based on the core laboratory ECG interpretation report.\n 16. Subject has a positive screening laboratory test result for human immunodeficiency virus (HIV).\n 17. Subject has a positive screening laboratory test result for hepatitis B surface antigen or hepatitis C antibodies and has liver function test results at screening above the ULN for the reference laboratory.\n 18. Subject has any other medical disorder that, in the opinion of the Investigator, could interfere with the subject's participation in the study.\n 19. Subject has major psychiatric disorder(s), including but not limited to: bipolar disorder, psychosis (eg, Parkinson's Disease Psychosis), major depressive episode, or any disorder that, in the opinion of the Investigator, would require treatment that could make study participation unsafe or make treatment compliance difficult.\n 20. History of clinically significant impulse control disorder(s).\n 21. History of symptomatic orthostatic hypotension requiring medication.\n 22. History of severe dyskinesia based on a score of 4 on the MDS-UPDRS Part IV.\n 23. Dementia that precludes providing informed consent or would interfere with participation in the study.\n 24. Current/recent suicidal ideation as evidenced by answering \"yes\" to \"Suicidal Ideation\" item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) on the C-SSRS assessment at screening (using the \"screening /Baseline Version\" scale, in the past 12 months) or attempted suicide within the last 5 years.\n 25. Presence of canker or mouth sores in the 30 days prior to SV1, or other clinically significant oral pathology in the opinion of the Investigator. The Investigator should follow-up with an appropriate specialist on any finding, if indicated, before enrolling a subject into the study","MAOB","monoamine oxidase B","Gene","Prostate","Actual","2018-01-05","Actual","Anticipated","2020-05-31","Anticipated","2019-01-01","2018-01-02","2018-01-02","2019-01-15","No","Parkinson's Disease\n\"Off\" Episodes\nmotor fluctuations associated with Parkinson's Disease","Interventional","Treatment","Crossover Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":4},"Yes",{"$nulls":12},"2016-003456-70","EudraCT Number","change from pre-dose to 90 minutes post-dose in MDS UPDRS Part III score after 4 weeks of dosing in each crossover period (assessed by the blinded-rater in-clinic at Visit 3 and Visit 6 of PART B).","Week 4",null,"Durability of effect, defined as an Investigator confirmed full \"ON\" within 30 minutes post dose and at 90 minutes post-dose, after 4 weeks of dosing in each crossover period (assessed by the blinded-rater in-clinic at Visit 3 and Visit 6 of PART B).|Subject preference for treatment regimen as measured by the Subject Preference Visual Analog Scale (VAS) after the subject has completed both APL 130277 and sc apomorphine treatment regimens (assessed in-clinic at Visit 6 of PART B).|Per the Expanded Home Dosing Diary, percent of \"ON\" episodes without troublesome dyskinesia based on the 3 consecutive days prior to Visit 2, Visit 3, Visit 5, and Visit 6.|Subject confirmed durability of effect, defined as subject confirmed full \"ON\" within 30 minutes post-dose and at 90 minutes post-dose, after 4 weeks of dosing in each crossover period (assessed in-clinic at Visit 3 and Visit 6 of PART B).|Patient Global Impression of Change (PGI-C): Subject improvement of \"OFF\" episodes, defined as very much better, much better or a little better after 4 weeks of dosing in each crossover period (assessed in-clinic at Visit 3 and Visit 6 of PART B).","Week 4|with a recorded range of -50 to 50. Negative values indicate preference for SC treatment, and the more negative the value, the stronger is the preference for SC compared to APL treatment. Positive values indicate preference for APL treatment, and the more positive the value, the stronger is the preference for APL compared to SC treatment. A value of 0 indicates no preference of one treatment over the other.","Week 4","clinicaltrialdisclousre@sunovion.com","CNS Medical Director","1-866-503-6351","Marseille, France, 13385|Haag In Oberbayern, Germany, 83527|Salerno, Italy, 84131|Sant Cugat Del Valles, Spain, 08195|London, United Kingdom, Se5 9Rs",null,"France|Germany|Italy|Spain|United Kingdom","Hopital La Timone, Neurologie Et Pathologie Due Mouvement|Klinik Haag I.Ob|Aou San Giovanni Di Dio E Ruggid'Aragona-Cemand|Hospital General De Catalunya|King's College Hospital Nhs Foundation Trust",{"$nulls":3},"CNS Medical Director","2019-01-15","2020-05-25T16:35:26.513","2020-05-26T17:10:42.972","NCT03391882"]
["5ecbf3ce11702c1b1b9169d0","NCT03391882","2019-01-22","Sunovion","SEPR","Recruiting","A Study of an Investigational Drug to See How it Affects the People With Parkinson's Disease Complicated by Motor Fluctuations (\"OFF\" Episodes) Compared to an Approved Drug Used to Treat People With Parkinson's Disease Complicated by Motor Fluctuations (\"OFF\" Episodes)","Apomorphine","DS Agonist","No",null,"No",null,"Phase 3",2,106,"Anticipated","2018-12-19","2020-05-24",{"$nulls":5},"A study of an investigational drug to see how it affects the people with Parkinson's Disease complicated by motor fluctuations (\"OFF\" Episodes) compared to an approved drug used to treat people with Parkinson's Disease complicated by motor fluctuations (\"OFF\" Episodes)","An Open-Label, Randomized, Crossover Trial utilizing a Single-Blinded Rater to evaluate APL-130277 compared to s.c. Apomorphine in Levodopa Responsive Subjects with Parkinson's Disease Complicated by Motor Fluctuations.\n\nPART A consists of an open label, crossover titration phase where eligible subjects will be randomized to 1 of 2 treatment sequences in a 1:1 ratio to Sublingual APL 130277 followed by subcutaneous apomorphine or subcutaneous apomorphine followed by sublingual APL 130277. Subjects will undergo dose titration with the first study treatment (APL 130277 or sc apomorphine) to tolerance and effect, ie, the tolerable dose that turns the subject from the practically defined \"OFF\" state to the full \"ON\" state as determined by both the Investigator and subject. The subject will then be crossed over to the other study treatment (APL 130277 or subcutaneous apomorphine) and similarly titrated to tolerance and effect. These determined doses of APL 130277 and subcutaneous apomorphine will be used during PART B.\n\nPART B consists of an open-label, crossover treatment period where subjects will be randomized to one of the study treatment for 4 weeks, then be crossed over to the other study treatment (APL-130277 or sc apomorphine) for additional 4-weeks of open-label treatment. Subjects return to the clinic for safety and efficacy assessments throughout the treatment period.\n\nThis study is designed to test the superiority of sublingually administered APL-130277 against subcutaneously injected apomorphine (APO-go) for the treatment of \"OFF\" episodes in patients with Parkinson's Disease, as measured by the change from pre-dose to 90 minutes post-dose in MDS UPDRS Part III score in Part B after 4 weeks of dosing in each crossover period.","An Open-Label, Randomized, Crossover Trial Utilizing a Single-Blinded Rater to Evaluate APL-130277 Compared to Subcutaneous Apomorphine in Levodopa Responsive Subjects With Parkinson's Disease Complicated by Motor Fluctuations","CTH-302","Motor OFF Episodes Associated With Parkinson's Disease","Parkinson Disease","Central Nervous System Diseases","Central Nervous System","Experimental|Active Comparator","APL-130277|subcutaneous apomorphine","APL-130277: Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A|subcutaneous apomorphine , Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A","Drug","APL-130277|subcutaneous apomorphine","APL-130277: Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A|subcutaneous apomorphine Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A","Apomorphine Hydrochloride|APO-goÂ®","APL-130277|subcutaneous apomorphine","\n\n 1.  The subject (and caregiver, if applicable) must be fully informed of and understand the objectives, procedures, and possible benefits and risks of the study, and give written informed consent prior to performing any study related activities.\n 2.  Male or female â‰¥ 18 years of age.\n 3.  Clinical diagnosis of Idiopathic PD, consistent with UK Brain Bank Criteria (excluding the \"more than one affected relative\" criterion).\n 4.  Clinically meaningful response to levodopa (L-Dopa), as determined by the Investigator.\n 5.  Subjects at screening must demonstrate an adequate L-Dopa response on the MDS UPDRS Part III in the \"ON\" state compared to the MDS UPDRS Part III in the \"OFF\" state and on the Hoehn and Yahr, as determined during the review by Enrollment Adjudication Committee (EAC), Sponsor, and Medical Monitor.\n 6.  Receiving stable doses of L Dopa/carbidopa and/or L Dopa/benserazide and/or L Dopa/carbidopa/entacapone (immediate or chronic release) administered at least 4 times per day OR Rytaryâ„¢ administered at least 3 times per day for at least 4 weeks before the initial screening Visit (SV1). Adjunctive PD medication regimens are permitted but must be maintained at a stable dose for at least 4 weeks prior to SV1 with the exception of monoamine oxidase B (MAO B) inhibitors, which must be maintained at a stable level for at least 8 weeks prior to SV1.\n 7.  No planned medication change(s) or surgical intervention anticipated during the course of study.\n 8.  Subjects must experience at least one well defined \"OFF\" episode per day and have a total daily \"OFF\" time duration of > 2 hours during the waking day, based on judgment of physician and subject self assessment.\n 9.  Subject must have predictable morning \"OFF\" periods, based on judgment of physician and subject self assessment.\n 10. Subject, and where appropriate caregiver, must be trained in completing the home dosing diaries and able to recognize \"ON\" and \"OFF\" states.\n 11. Stage III or less on the modified Hoehn and Yahr scale in the \"ON\" state.\n 12. Mini-Mental State Examination (MMSE) score > 25.\n 13. Female subject of childbearing potential and male subject with female partner of childbearing potential must agree to either remain abstinent or use adequate and reliable contraception throughout the study and for at least 7 days after the last dose of study drug has been taken. Note: Continued use of adequate and reliable contraception is recommended through 30 days after study completion.\n 14. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study related procedures to complete the study.\n 15. Must be approved as a satisfactory candidate by the Enrollment Adjudication Committee (EAC), Medical Monitor, and Sponsor.\n\n","\n\n 1.  Atypical or secondary parkinsonism.\n 2.  Major focal brain disorders including malignancy or stroke.\n 3.  Prior treatment with any of the following: a neurosurgical procedure for PD; continuous subcutaneous (subcutaneous) apomorphine infusion; subcutaneous (subcutaneous) apomorphine injection; Duodopa/Duopa; or APL-130277.\n 4.  Contraindications to domperidone, subcutaneous apomorphine, or hypersensitivity to apomorphine hydrochloride or any of the ingredients of subcutaneous apomorphine (notably sodium metabisulfite).\n 5.  Female who is pregnant or lactating.\n 6.  Participation in an interventional clinical study and/or receipt of any investigational (ie, unapproved) medication within 30 days prior to SV1.\n 7.  Currently taking selective 5HT3 antagonists (ie, ondansetron, granisetron, dolasetron, palonosetron, alosetron), dopamine antagonists (excluding quetiapine or clozapine) or dopamine depleting agents. Subjects receiving anti depressants must be on a stable daily dose for at least 8 weeks prior to SV1.\n 8.  The subject has a current diagnosis or history of substance abuse (excluding nicotine and caffeine) or alcohol abuse (in the opinion of the investigator) < 6 months prior to SV1.\n 9.  The recreational use of cannabinoids and hallucinogenic are excluded, as well any use of a sublingual formulation of any drug.\n 10. Subject has a history of malignancy within 5 years prior to SV1, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.\n 11. Subject has a clinically significant abnormality on screening evaluation including physical examination, vital signs, electrocardiogram (ECG), or laboratory tests that the Investigator considers to be inappropriate to allow participation in the study.\n 12. Subject has screening laboratory test results of: blood urea nitrogen (BUN) value â‰¥ 1.5 times the upper limit of normal (ULN) for the reference range; serum creatinine > 1.5 times the ULN for the reference range; or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value â‰¥ 2 times the ULN for the reference laboratory.\n 13. Subject has random (non-fasting) screening glucose of â‰¥ 200 mg/dL (11.1 mmol/L) or HbA1c > 7.0%.\n 14. Subjects with type 1 diabetes, or insulin dependent diabetics are excluded. Subjects with type 2 diabetes are eligible for study inclusion if the following conditions are met: * Subject's screening glucose is < 200 mg/dL (11.1 mmol/L). Note: Subjects with random (non fasting) blood glucose at screening â‰¥ 200 mg/dL (11.1 mmol/L) must be retested in a fasted state; and\n      * Subject's hemoglobin A1c (HbA1c) â‰¤ 7.0%; and\n      * If the subject is currently being treated with oral anti-diabetic medication(s), the dose must have been stable for at least 4 weeks prior to SV1. Such medication may be adjusted or discontinued during the study, as clinically indicated.\n     \n     \n 15. The subject's screening ECG results of corrected QT interval using Fridericia's formula (QTcF) â‰¥ 450 msec for male subjects or â‰¥ 470 msec for female subjects. Eligibility will be based on the core laboratory ECG interpretation report.\n 16. Subject has a positive screening laboratory test result for human immunodeficiency virus (HIV).\n 17. Subject has a positive screening laboratory test result for hepatitis B surface antigen or hepatitis C antibodies and has liver function test results at screening above the ULN for the reference laboratory.\n 18. Subject has any other medical disorder that, in the opinion of the Investigator, could interfere with the subject's participation in the study.\n 19. Subject has major psychiatric disorder(s), including but not limited to: bipolar disorder, psychosis (eg, Parkinson's Disease Psychosis), major depressive episode, or any disorder that, in the opinion of the Investigator, would require treatment that could make study participation unsafe or make treatment compliance difficult.\n 20. History of clinically significant impulse control disorder(s).\n 21. History of symptomatic orthostatic hypotension requiring medication.\n 22. History of severe dyskinesia based on a score of 4 on the MDS-UPDRS Part IV.\n 23. Dementia that precludes providing informed consent or would interfere with participation in the study.\n 24. Current/recent suicidal ideation as evidenced by answering \"yes\" to \"Suicidal Ideation\" item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) on the C-SSRS assessment at screening (using the \"screening /Baseline Version\" scale, in the past 12 months) or attempted suicide within the last 5 years.\n 25. Presence of canker or mouth sores in the 30 days prior to SV1, or other clinically significant oral pathology in the opinion of the Investigator. The Investigator should follow-up with an appropriate specialist on any finding, if indicated, before enrolling a subject into the study","MAOB","monoamine oxidase B","Gene","Prostate","Actual","2018-01-05","Actual","Anticipated","2020-05-31","Anticipated","2019-01-01","2018-01-02","2018-01-02","2019-01-18","No","Parkinson's Disease\n\"Off\" Episodes\nmotor fluctuations associated with Parkinson's Disease","Interventional","Treatment","Crossover Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":4},"Yes",{"$nulls":12},"2016-003456-70","EudraCT Number","change from pre-dose to 90 minutes post-dose in MDS UPDRS Part III score after 4 weeks of dosing in each crossover period (assessed by the blinded-rater in-clinic at Visit 3 and Visit 6 of PART B).","Week 4",null,"Durability of effect, defined as an Investigator confirmed full \"ON\" within 30 minutes post dose and at 90 minutes post-dose, after 4 weeks of dosing in each crossover period (assessed by the blinded-rater in-clinic at Visit 3 and Visit 6 of PART B).|Subject preference for treatment regimen as measured by the Subject Preference Visual Analog Scale (VAS) after the subject has completed both APL 130277 and sc apomorphine treatment regimens (assessed in-clinic at Visit 6 of PART B).|Per the Expanded Home Dosing Diary, percent of \"ON\" episodes without troublesome dyskinesia based on the 3 consecutive days prior to Visit 2, Visit 3, Visit 5, and Visit 6.|Subject confirmed durability of effect, defined as subject confirmed full \"ON\" within 30 minutes post-dose and at 90 minutes post-dose, after 4 weeks of dosing in each crossover period (assessed in-clinic at Visit 3 and Visit 6 of PART B).|Patient Global Impression of Change (PGI-C): Subject improvement of \"OFF\" episodes, defined as very much better, much better or a little better after 4 weeks of dosing in each crossover period (assessed in-clinic at Visit 3 and Visit 6 of PART B).","Week 4|with a recorded range of -50 to 50. Negative values indicate preference for SC treatment, and the more negative the value, the stronger is the preference for SC compared to APL treatment. Positive values indicate preference for APL treatment, and the more positive the value, the stronger is the preference for APL compared to SC treatment. A value of 0 indicates no preference of one treatment over the other.","Week 4","clinicaltrialdisclosure@sunovion.com","CNS Medical Director","1-866-503-6351","Marseille, France, 13385|Haag In Oberbayern, Germany, 83527|Salerno, Italy, 84131|Barcelona, Spain, 08036|London, United Kingdom, Se5 9Rs",null,"France|Germany|Italy|Spain|United Kingdom","Hopital La Timone, Neurologie Et Pathologie Due Mouvement|Klinik Haag I.Ob|Aou San Giovanni Di Dio E Ruggid'Aragona-Cemand|Hospital Clinic De Barcelona|King's College Hospital Nhs Foundation Trust",{"$nulls":3},"CNS Medical Director","2019-01-18","2020-05-25T16:35:26.513","2020-05-26T17:10:42.972","NCT03391882"]
["5ecbf3cee2561b1b11905cb9","NCT03391882","2019-01-25","Sunovion","SEPR","Recruiting","A Study of an Investigational Drug to See How it Affects the People With Parkinson's Disease Complicated by Motor Fluctuations (\"OFF\" Episodes) Compared to an Approved Drug Used to Treat People With Parkinson's Disease Complicated by Motor Fluctuations (\"OFF\" Episodes)","Apomorphine","DS Agonist","No",null,"No",null,"Phase 3",2,106,"Anticipated","2018-12-19","2020-05-24",{"$nulls":5},"A study of an investigational drug to see how it affects the people with Parkinson's Disease complicated by motor fluctuations (\"OFF\" Episodes) compared to an approved drug used to treat people with Parkinson's Disease complicated by motor fluctuations (\"OFF\" Episodes)","An Open-Label, Randomized, Crossover Trial utilizing a Single-Blinded Rater to evaluate APL-130277 compared to s.c. Apomorphine in Levodopa Responsive Subjects with Parkinson's Disease Complicated by Motor Fluctuations.\n\nPART A consists of an open label, crossover titration phase where eligible subjects will be randomized to 1 of 2 treatment sequences in a 1:1 ratio to Sublingual APL 130277 followed by subcutaneous apomorphine or subcutaneous apomorphine followed by sublingual APL 130277. Subjects will undergo dose titration with the first study treatment (APL 130277 or sc apomorphine) to tolerance and effect, ie, the tolerable dose that turns the subject from the practically defined \"OFF\" state to the full \"ON\" state as determined by both the Investigator and subject. The subject will then be crossed over to the other study treatment (APL 130277 or subcutaneous apomorphine) and similarly titrated to tolerance and effect. These determined doses of APL 130277 and subcutaneous apomorphine will be used during PART B.\n\nPART B consists of an open-label, crossover treatment period where subjects will be randomized to one of the study treatment for 4 weeks, then be crossed over to the other study treatment (APL-130277 or sc apomorphine) for additional 4-weeks of open-label treatment. Subjects return to the clinic for safety and efficacy assessments throughout the treatment period.\n\nThis study is designed to test the superiority of sublingually administered APL-130277 against subcutaneously injected apomorphine (APO-go) for the treatment of \"OFF\" episodes in patients with Parkinson's Disease, as measured by the change from pre-dose to 90 minutes post-dose in MDS UPDRS Part III score in Part B after 4 weeks of dosing in each crossover period.","An Open-Label, Randomized, Crossover Trial Utilizing a Single-Blinded Rater to Evaluate APL-130277 Compared to Subcutaneous Apomorphine in Levodopa Responsive Subjects With Parkinson's Disease Complicated by Motor Fluctuations","CTH-302","Motor OFF Episodes Associated With Parkinson's Disease","Parkinson Disease","Central Nervous System Diseases","Central Nervous System","Experimental|Active Comparator","APL-130277|subcutaneous apomorphine","APL-130277: Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A|subcutaneous apomorphine , Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A","Drug","APL-130277|subcutaneous apomorphine","APL-130277: Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A|subcutaneous apomorphine Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A","Apomorphine Hydrochloride|APO-goÂ®","APL-130277|subcutaneous apomorphine","\n\n 1.  The subject (and caregiver, if applicable) must be fully informed of and understand the objectives, procedures, and possible benefits and risks of the study, and give written informed consent prior to performing any study related activities.\n 2.  Male or female â‰¥ 18 years of age.\n 3.  Clinical diagnosis of Idiopathic PD, consistent with UK Brain Bank Criteria (excluding the \"more than one affected relative\" criterion).\n 4.  Clinically meaningful response to levodopa (L-Dopa), as determined by the Investigator.\n 5.  Subjects at screening must demonstrate an adequate L-Dopa response on the MDS UPDRS Part III in the \"ON\" state compared to the MDS UPDRS Part III in the \"OFF\" state and on the Hoehn and Yahr, as determined during the review by Enrollment Adjudication Committee (EAC), Sponsor, and Medical Monitor.\n 6.  Receiving stable doses of L Dopa/carbidopa and/or L Dopa/benserazide and/or L Dopa/carbidopa/entacapone (immediate or chronic release) administered at least 4 times per day OR Rytaryâ„¢ administered at least 3 times per day for at least 4 weeks before the initial screening Visit (SV1). Adjunctive PD medication regimens are permitted but must be maintained at a stable dose for at least 4 weeks prior to SV1 with the exception of monoamine oxidase B (MAO B) inhibitors, which must be maintained at a stable level for at least 8 weeks prior to SV1.\n 7.  No planned medication change(s) or surgical intervention anticipated during the course of study.\n 8.  Subjects must experience at least one well defined \"OFF\" episode per day and have a total daily \"OFF\" time duration of > 2 hours during the waking day, based on judgment of physician and subject self assessment.\n 9.  Subject must have predictable morning \"OFF\" periods, based on judgment of physician and subject self assessment.\n 10. Subject, and where appropriate caregiver, must be trained in completing the home dosing diaries and able to recognize \"ON\" and \"OFF\" states.\n 11. Stage III or less on the modified Hoehn and Yahr scale in the \"ON\" state.\n 12. Mini-Mental State Examination (MMSE) score > 25.\n 13. Female subject of childbearing potential and male subject with female partner of childbearing potential must agree to either remain abstinent or use adequate and reliable contraception throughout the study and for at least 7 days after the last dose of study drug has been taken. Note: Continued use of adequate and reliable contraception is recommended through 30 days after study completion.\n 14. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study related procedures to complete the study.\n 15. Must be approved as a satisfactory candidate by the Enrollment Adjudication Committee (EAC), Medical Monitor, and Sponsor.\n\n","\n\n 1.  Atypical or secondary parkinsonism.\n 2.  Major focal brain disorders including malignancy or stroke.\n 3.  Prior treatment with any of the following: a neurosurgical procedure for PD; continuous subcutaneous (subcutaneous) apomorphine infusion; subcutaneous (subcutaneous) apomorphine injection; Duodopa/Duopa; or APL-130277.\n 4.  Contraindications to domperidone, subcutaneous apomorphine, or hypersensitivity to apomorphine hydrochloride or any of the ingredients of subcutaneous apomorphine (notably sodium metabisulfite).\n 5.  Female who is pregnant or lactating.\n 6.  Participation in an interventional clinical study and/or receipt of any investigational (ie, unapproved) medication within 30 days prior to SV1.\n 7.  Currently taking selective 5HT3 antagonists (ie, ondansetron, granisetron, dolasetron, palonosetron, alosetron), dopamine antagonists (excluding quetiapine or clozapine) or dopamine depleting agents. Subjects receiving anti depressants must be on a stable daily dose for at least 8 weeks prior to SV1.\n 8.  The subject has a current diagnosis or history of substance abuse (excluding nicotine and caffeine) or alcohol abuse (in the opinion of the investigator) < 6 months prior to SV1.\n 9.  The recreational use of cannabinoids and hallucinogenic are excluded, as well any use of a sublingual formulation of any drug.\n 10. Subject has a history of malignancy within 5 years prior to SV1, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.\n 11. Subject has a clinically significant abnormality on screening evaluation including physical examination, vital signs, electrocardiogram (ECG), or laboratory tests that the Investigator considers to be inappropriate to allow participation in the study.\n 12. Subject has screening laboratory test results of: blood urea nitrogen (BUN) value â‰¥ 1.5 times the upper limit of normal (ULN) for the reference range; serum creatinine > 1.5 times the ULN for the reference range; or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value â‰¥ 2 times the ULN for the reference laboratory.\n 13. Subject has random (non-fasting) screening glucose of â‰¥ 200 mg/dL (11.1 mmol/L) or HbA1c > 7.0%.\n 14. Subjects with type 1 diabetes, or insulin dependent diabetics are excluded. Subjects with type 2 diabetes are eligible for study inclusion if the following conditions are met: * Subject's screening glucose is < 200 mg/dL (11.1 mmol/L). Note: Subjects with random (non fasting) blood glucose at screening â‰¥ 200 mg/dL (11.1 mmol/L) must be retested in a fasted state; and\n      * Subject's hemoglobin A1c (HbA1c) â‰¤ 7.0%; and\n      * If the subject is currently being treated with oral anti-diabetic medication(s), the dose must have been stable for at least 4 weeks prior to SV1. Such medication may be adjusted or discontinued during the study, as clinically indicated.\n     \n     \n 15. The subject's screening ECG results of corrected QT interval using Fridericia's formula (QTcF) â‰¥ 450 msec for male subjects or â‰¥ 470 msec for female subjects. Eligibility will be based on the core laboratory ECG interpretation report.\n 16. Subject has a positive screening laboratory test result for human immunodeficiency virus (HIV).\n 17. Subject has a positive screening laboratory test result for hepatitis B surface antigen or hepatitis C antibodies and has liver function test results at screening above the ULN for the reference laboratory.\n 18. Subject has any other medical disorder that, in the opinion of the Investigator, could interfere with the subject's participation in the study.\n 19. Subject has major psychiatric disorder(s), including but not limited to: bipolar disorder, psychosis (eg, Parkinson's Disease Psychosis), major depressive episode, or any disorder that, in the opinion of the Investigator, would require treatment that could make study participation unsafe or make treatment compliance difficult.\n 20. History of clinically significant impulse control disorder(s).\n 21. History of symptomatic orthostatic hypotension requiring medication.\n 22. History of severe dyskinesia based on a score of 4 on the MDS-UPDRS Part IV.\n 23. Dementia that precludes providing informed consent or would interfere with participation in the study.\n 24. Current/recent suicidal ideation as evidenced by answering \"yes\" to \"Suicidal Ideation\" item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) on the C-SSRS assessment at screening (using the \"screening /Baseline Version\" scale, in the past 12 months) or attempted suicide within the last 5 years.\n 25. Presence of canker or mouth sores in the 30 days prior to SV1, or other clinically significant oral pathology in the opinion of the Investigator. The Investigator should follow-up with an appropriate specialist on any finding, if indicated, before enrolling a subject into the study","MAOB","monoamine oxidase B","Gene","Prostate","Actual","2018-01-05","Actual","Anticipated","2020-05-31","Anticipated","2019-01-01","2018-01-02","2018-01-02","2019-01-24","No","Parkinson's Disease\n\"Off\" Episodes\nmotor fluctuations associated with Parkinson's Disease","Interventional","Treatment","Crossover Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":4},"Yes",{"$nulls":12},"2016-003456-70","EudraCT Number","change from pre-dose to 90 minutes post-dose in MDS UPDRS Part III score after 4 weeks of dosing in each crossover period (assessed by the blinded-rater in-clinic at Visit 3 and Visit 6 of PART B).","Week 4",null,"Durability of effect, defined as an Investigator confirmed full \"ON\" within 30 minutes post dose and at 90 minutes post-dose, after 4 weeks of dosing in each crossover period (assessed by the blinded-rater in-clinic at Visit 3 and Visit 6 of PART B).|Subject preference for treatment regimen as measured by the Subject Preference Visual Analog Scale (VAS) after the subject has completed both APL 130277 and sc apomorphine treatment regimens (assessed in-clinic at Visit 6 of PART B).|Per the Expanded Home Dosing Diary, percent of \"ON\" episodes without troublesome dyskinesia based on the 3 consecutive days prior to Visit 2, Visit 3, Visit 5, and Visit 6.|Subject confirmed durability of effect, defined as subject confirmed full \"ON\" within 30 minutes post-dose and at 90 minutes post-dose, after 4 weeks of dosing in each crossover period (assessed in-clinic at Visit 3 and Visit 6 of PART B).|Patient Global Impression of Change (PGI-C): Subject improvement of \"OFF\" episodes, defined as very much better, much better or a little better after 4 weeks of dosing in each crossover period (assessed in-clinic at Visit 3 and Visit 6 of PART B).","Week 4|with a recorded range of -50 to 50. Negative values indicate preference for SC treatment, and the more negative the value, the stronger is the preference for SC compared to APL treatment. Positive values indicate preference for APL treatment, and the more positive the value, the stronger is the preference for APL compared to SC treatment. A value of 0 indicates no preference of one treatment over the other.","Week 4","clinicaltrialdisclosure@sunovion.com","CNS Medical Director","1-866-503-6351","Innsbruck, Austria, A-6020|Marseille, France, 13385|Haag In Oberbayern, Germany, 83527|Salerno, Italy, 84131|Barcelona, Spain, 08036|London, United Kingdom, Se5 9Rs",null,"Austria|France|Germany|Italy|Spain|United Kingdom","Medical University Innsbruck, Neurolgy Dept|Hopital La Timone, Neurologie Et Pathologie Due Mouvement|Klinik Haag I.Ob|Aou San Giovanni Di Dio E Ruggid'Aragona-Cemand|Hospital Clinic De Barcelona|King's College Hospital Nhs Foundation Trust",{"$nulls":3},"CNS Medical Director","2019-01-24","2020-05-25T16:35:26.926","2020-05-26T17:10:42.972","NCT03391882"]
["5ecbf3ce307e3d1b1f8d9c4d","NCT03391882","2019-02-04","Sunovion","SEPR","Recruiting","A Study of an Investigational Drug to See How it Affects the People With Parkinson's Disease Complicated by Motor Fluctuations (\"OFF\" Episodes) Compared to an Approved Drug Used to Treat People With Parkinson's Disease Complicated by Motor Fluctuations (\"OFF\" Episodes)","Apomorphine","DS Agonist","No",null,"No",null,"Phase 3",2,106,"Anticipated","2018-12-19","2020-05-24",{"$nulls":5},"A study of an investigational drug to see how it affects the people with Parkinson's Disease complicated by motor fluctuations (\"OFF\" Episodes) compared to an approved drug used to treat people with Parkinson's Disease complicated by motor fluctuations (\"OFF\" Episodes)","An Open-Label, Randomized, Crossover Trial utilizing a Single-Blinded Rater to evaluate APL-130277 compared to s.c. Apomorphine in Levodopa Responsive Subjects with Parkinson's Disease Complicated by Motor Fluctuations.\n\nPART A consists of an open label, crossover titration phase where eligible subjects will be randomized to 1 of 2 treatment sequences in a 1:1 ratio to Sublingual APL 130277 followed by subcutaneous apomorphine or subcutaneous apomorphine followed by sublingual APL 130277. Subjects will undergo dose titration with the first study treatment (APL 130277 or sc apomorphine) to tolerance and effect, ie, the tolerable dose that turns the subject from the practically defined \"OFF\" state to the full \"ON\" state as determined by both the Investigator and subject. The subject will then be crossed over to the other study treatment (APL 130277 or subcutaneous apomorphine) and similarly titrated to tolerance and effect. These determined doses of APL 130277 and subcutaneous apomorphine will be used during PART B.\n\nPART B consists of an open-label, crossover treatment period where subjects will be randomized to one of the study treatment for 4 weeks, then be crossed over to the other study treatment (APL-130277 or sc apomorphine) for additional 4-weeks of open-label treatment. Subjects return to the clinic for safety and efficacy assessments throughout the treatment period.\n\nThis study is designed to test the superiority of sublingually administered APL-130277 against subcutaneously injected apomorphine (APO-go) for the treatment of \"OFF\" episodes in patients with Parkinson's Disease, as measured by the change from pre-dose to 90 minutes post-dose in MDS UPDRS Part III score in Part B after 4 weeks of dosing in each crossover period.","An Open-Label, Randomized, Crossover Trial Utilizing a Single-Blinded Rater to Evaluate APL-130277 Compared to Subcutaneous Apomorphine in Levodopa Responsive Subjects With Parkinson's Disease Complicated by Motor Fluctuations","CTH-302","Motor OFF Episodes Associated With Parkinson's Disease","Parkinson Disease","Central Nervous System Diseases","Central Nervous System","Experimental|Active Comparator","APL-130277|subcutaneous apomorphine","APL-130277: Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A|subcutaneous apomorphine , Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A","Drug","APL-130277|subcutaneous apomorphine","APL-130277: Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A|subcutaneous apomorphine Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A","Apomorphine Hydrochloride|APO-goÂ®","APL-130277|subcutaneous apomorphine","\n\n 1.  The subject (and caregiver, if applicable) must be fully informed of and understand the objectives, procedures, and possible benefits and risks of the study, and give written informed consent prior to performing any study related activities.\n 2.  Male or female â‰¥ 18 years of age.\n 3.  Clinical diagnosis of Idiopathic PD, consistent with UK Brain Bank Criteria (excluding the \"more than one affected relative\" criterion).\n 4.  Clinically meaningful response to levodopa (L-Dopa), as determined by the Investigator.\n 5.  Subjects at screening must demonstrate an adequate L-Dopa response on the MDS UPDRS Part III in the \"ON\" state compared to the MDS UPDRS Part III in the \"OFF\" state and on the Hoehn and Yahr, as determined during the review by Enrollment Adjudication Committee (EAC), Sponsor, and Medical Monitor.\n 6.  Receiving stable doses of L Dopa/carbidopa and/or L Dopa/benserazide and/or L Dopa/carbidopa/entacapone (immediate or chronic release) administered at least 4 times per day OR Rytaryâ„¢ administered at least 3 times per day for at least 4 weeks before the initial screening Visit (SV1). Adjunctive PD medication regimens are permitted but must be maintained at a stable dose for at least 4 weeks prior to SV1 with the exception of monoamine oxidase B (MAO B) inhibitors, which must be maintained at a stable level for at least 8 weeks prior to SV1.\n 7.  No planned medication change(s) or surgical intervention anticipated during the course of study.\n 8.  Subjects must experience at least one well defined \"OFF\" episode per day and have a total daily \"OFF\" time duration of > 2 hours during the waking day, based on judgment of physician and subject self assessment.\n 9.  Subject must have predictable morning \"OFF\" periods, based on judgment of physician and subject self assessment.\n 10. Subject, and where appropriate caregiver, must be trained in completing the home dosing diaries and able to recognize \"ON\" and \"OFF\" states.\n 11. Stage III or less on the modified Hoehn and Yahr scale in the \"ON\" state.\n 12. Mini-Mental State Examination (MMSE) score > 25.\n 13. Female subject of childbearing potential and male subject with female partner of childbearing potential must agree to either remain abstinent or use adequate and reliable contraception throughout the study and for at least 7 days after the last dose of study drug has been taken. Note: Continued use of adequate and reliable contraception is recommended through 30 days after study completion.\n 14. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study related procedures to complete the study.\n 15. Must be approved as a satisfactory candidate by the Enrollment Adjudication Committee (EAC), Medical Monitor, and Sponsor.\n\n","\n\n 1.  Atypical or secondary parkinsonism.\n 2.  Major focal brain disorders including malignancy or stroke.\n 3.  Prior treatment with any of the following: a neurosurgical procedure for PD; continuous subcutaneous (subcutaneous) apomorphine infusion; subcutaneous (subcutaneous) apomorphine injection; Duodopa/Duopa; or APL-130277.\n 4.  Contraindications to domperidone, subcutaneous apomorphine, or hypersensitivity to apomorphine hydrochloride or any of the ingredients of subcutaneous apomorphine (notably sodium metabisulfite).\n 5.  Female who is pregnant or lactating.\n 6.  Participation in an interventional clinical study and/or receipt of any investigational (ie, unapproved) medication within 30 days prior to SV1.\n 7.  Currently taking selective 5HT3 antagonists (ie, ondansetron, granisetron, dolasetron, palonosetron, alosetron), dopamine antagonists (excluding quetiapine or clozapine) or dopamine depleting agents. Subjects receiving anti depressants must be on a stable daily dose for at least 8 weeks prior to SV1.\n 8.  The subject has a current diagnosis or history of substance abuse (excluding nicotine and caffeine) or alcohol abuse (in the opinion of the investigator) < 6 months prior to SV1.\n 9.  The recreational use of cannabinoids and hallucinogenic are excluded, as well any use of a sublingual formulation of any drug.\n 10. Subject has a history of malignancy within 5 years prior to SV1, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.\n 11. Subject has a clinically significant abnormality on screening evaluation including physical examination, vital signs, electrocardiogram (ECG), or laboratory tests that the Investigator considers to be inappropriate to allow participation in the study.\n 12. Subject has screening laboratory test results of: blood urea nitrogen (BUN) value â‰¥ 1.5 times the upper limit of normal (ULN) for the reference range; serum creatinine > 1.5 times the ULN for the reference range; or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value â‰¥ 2 times the ULN for the reference laboratory.\n 13. Subject has random (non-fasting) screening glucose of â‰¥ 200 mg/dL (11.1 mmol/L) or HbA1c > 7.0%.\n 14. Subjects with type 1 diabetes, or insulin dependent diabetics are excluded. Subjects with type 2 diabetes are eligible for study inclusion if the following conditions are met: * Subject's screening glucose is < 200 mg/dL (11.1 mmol/L). Note: Subjects with random (non fasting) blood glucose at screening â‰¥ 200 mg/dL (11.1 mmol/L) must be retested in a fasted state; and\n      * Subject's hemoglobin A1c (HbA1c) â‰¤ 7.0%; and\n      * If the subject is currently being treated with oral anti-diabetic medication(s), the dose must have been stable for at least 4 weeks prior to SV1. Such medication may be adjusted or discontinued during the study, as clinically indicated.\n     \n     \n 15. The subject's screening ECG results of corrected QT interval using Fridericia's formula (QTcF) â‰¥ 450 msec for male subjects or â‰¥ 470 msec for female subjects. Eligibility will be based on the core laboratory ECG interpretation report.\n 16. Subject has a positive screening laboratory test result for human immunodeficiency virus (HIV).\n 17. Subject has a positive screening laboratory test result for hepatitis B surface antigen or hepatitis C antibodies and has liver function test results at screening above the ULN for the reference laboratory.\n 18. Subject has any other medical disorder that, in the opinion of the Investigator, could interfere with the subject's participation in the study.\n 19. Subject has major psychiatric disorder(s), including but not limited to: bipolar disorder, psychosis (eg, Parkinson's Disease Psychosis), major depressive episode, or any disorder that, in the opinion of the Investigator, would require treatment that could make study participation unsafe or make treatment compliance difficult.\n 20. History of clinically significant impulse control disorder(s).\n 21. History of symptomatic orthostatic hypotension requiring medication.\n 22. History of severe dyskinesia based on a score of 4 on the MDS-UPDRS Part IV.\n 23. Dementia that precludes providing informed consent or would interfere with participation in the study.\n 24. Current/recent suicidal ideation as evidenced by answering \"yes\" to \"Suicidal Ideation\" item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) on the C-SSRS assessment at screening (using the \"screening /Baseline Version\" scale, in the past 12 months) or attempted suicide within the last 5 years.\n 25. Presence of canker or mouth sores in the 30 days prior to SV1, or other clinically significant oral pathology in the opinion of the Investigator. The Investigator should follow-up with an appropriate specialist on any finding, if indicated, before enrolling a subject into the study","MAOB","monoamine oxidase B","Gene","Prostate","Actual","2018-01-05","Actual","Anticipated","2020-05-31","Anticipated","2019-01-01","2018-01-02","2018-01-02","2019-01-31","No","Parkinson's Disease\n\"Off\" Episodes\nmotor fluctuations associated with Parkinson's Disease","Interventional","Treatment","Crossover Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":4},"Yes",{"$nulls":12},"2016-003456-70","EudraCT Number","change from pre-dose to 90 minutes post-dose in MDS UPDRS Part III score after 4 weeks of dosing in each crossover period (assessed by the blinded-rater in-clinic at Visit 3 and Visit 6 of PART B).","Week 4",null,"Durability of effect, defined as an Investigator confirmed full \"ON\" within 30 minutes post dose and at 90 minutes post-dose, after 4 weeks of dosing in each crossover period (assessed by the blinded-rater in-clinic at Visit 3 and Visit 6 of PART B).|Subject preference for treatment regimen as measured by the Subject Preference Visual Analog Scale (VAS) after the subject has completed both APL 130277 and sc apomorphine treatment regimens (assessed in-clinic at Visit 6 of PART B).|Per the Expanded Home Dosing Diary, percent of \"ON\" episodes without troublesome dyskinesia based on the 3 consecutive days prior to Visit 2, Visit 3, Visit 5, and Visit 6.|Subject confirmed durability of effect, defined as subject confirmed full \"ON\" within 30 minutes post-dose and at 90 minutes post-dose, after 4 weeks of dosing in each crossover period (assessed in-clinic at Visit 3 and Visit 6 of PART B).|Patient Global Impression of Change (PGI-C): Subject improvement of \"OFF\" episodes, defined as very much better, much better or a little better after 4 weeks of dosing in each crossover period (assessed in-clinic at Visit 3 and Visit 6 of PART B).","Week 4|with a recorded range of -50 to 50. Negative values indicate preference for SC treatment, and the more negative the value, the stronger is the preference for SC compared to APL treatment. Positive values indicate preference for APL treatment, and the more positive the value, the stronger is the preference for APL compared to SC treatment. A value of 0 indicates no preference of one treatment over the other.","Week 4","clinicaltrialdisclosure@sunovion.com","CNS Medical Director","1-866-503-6351","Innsbruck, Austria, A-6020|Marseille, France, 13385|Beelitz-Heilstatten, Germany, 14547|Cassino, Italy, 03043|Barcelona, Spain, 08036|London, United Kingdom, Se5 9Rs",null,"Austria|France|Germany|Italy|Spain|United Kingdom","Medical University Innsbruck, Neurolgy Dept|Hopital La Timone, Neurologie Et Pathologie Due Mouvement|Klinken Beelitz Gmbh Neurologisches Fachkrankenhaus Fur Bewegungsstorungen/Parkinson|San Raffaele Cassino|Hospital Clinic De Barcelona|King's College Hospital Nhs Foundation Trust",{"$nulls":3},"CNS Medical Director","2019-01-31","2020-05-25T16:35:26.753","2020-05-26T17:10:42.972","NCT03391882"]
["5ecbf3cefe30261b1a0481be","NCT03391882","2019-02-06","Sunovion","SEPR","Recruiting","A Study of an Investigational Drug to See How it Affects the People With Parkinson's Disease Complicated by Motor Fluctuations (\"OFF\" Episodes) Compared to an Approved Drug Used to Treat People With Parkinson's Disease Complicated by Motor Fluctuations (\"OFF\" Episodes)","Apomorphine","DS Agonist","No",null,"No",null,"Phase 3",2,106,"Anticipated","2018-12-19","2020-05-24",{"$nulls":5},"A study of an investigational drug to see how it affects the people with Parkinson's Disease complicated by motor fluctuations (\"OFF\" Episodes) compared to an approved drug used to treat people with Parkinson's Disease complicated by motor fluctuations (\"OFF\" Episodes)","An Open-Label, Randomized, Crossover Trial utilizing a Single-Blinded Rater to evaluate APL-130277 compared to s.c. Apomorphine in Levodopa Responsive Subjects with Parkinson's Disease Complicated by Motor Fluctuations.\n\nPART A consists of an open label, crossover titration phase where eligible subjects will be randomized to 1 of 2 treatment sequences in a 1:1 ratio to Sublingual APL 130277 followed by subcutaneous apomorphine or subcutaneous apomorphine followed by sublingual APL 130277. Subjects will undergo dose titration with the first study treatment (APL 130277 or sc apomorphine) to tolerance and effect, ie, the tolerable dose that turns the subject from the practically defined \"OFF\" state to the full \"ON\" state as determined by both the Investigator and subject. The subject will then be crossed over to the other study treatment (APL 130277 or subcutaneous apomorphine) and similarly titrated to tolerance and effect. These determined doses of APL 130277 and subcutaneous apomorphine will be used during PART B.\n\nPART B consists of an open-label, crossover treatment period where subjects will be randomized to one of the study treatment for 4 weeks, then be crossed over to the other study treatment (APL-130277 or sc apomorphine) for additional 4-weeks of open-label treatment. Subjects return to the clinic for safety and efficacy assessments throughout the treatment period.\n\nThis study is designed to test the superiority of sublingually administered APL-130277 against subcutaneously injected apomorphine (APO-go) for the treatment of \"OFF\" episodes in patients with Parkinson's Disease, as measured by the change from pre-dose to 90 minutes post-dose in MDS UPDRS Part III score in Part B after 4 weeks of dosing in each crossover period.","An Open-Label, Randomized, Crossover Trial Utilizing a Single-Blinded Rater to Evaluate APL-130277 Compared to Subcutaneous Apomorphine in Levodopa Responsive Subjects With Parkinson's Disease Complicated by Motor Fluctuations","CTH-302","Motor OFF Episodes Associated With Parkinson's Disease","Parkinson Disease","Central Nervous System Diseases","Central Nervous System","Experimental|Active Comparator","APL-130277|subcutaneous apomorphine","APL-130277: Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A|subcutaneous apomorphine , Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A","Drug","APL-130277|subcutaneous apomorphine","APL-130277: Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A|subcutaneous apomorphine Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A","Apomorphine Hydrochloride|APO-goÂ®","APL-130277|subcutaneous apomorphine","\n\n 1.  The subject (and caregiver, if applicable) must be fully informed of and understand the objectives, procedures, and possible benefits and risks of the study, and give written informed consent prior to performing any study related activities.\n 2.  Male or female â‰¥ 18 years of age.\n 3.  Clinical diagnosis of Idiopathic PD, consistent with UK Brain Bank Criteria (excluding the \"more than one affected relative\" criterion).\n 4.  Clinically meaningful response to levodopa (L-Dopa), as determined by the Investigator.\n 5.  Subjects at screening must demonstrate an adequate L-Dopa response on the MDS UPDRS Part III in the \"ON\" state compared to the MDS UPDRS Part III in the \"OFF\" state and on the Hoehn and Yahr, as determined during the review by Enrollment Adjudication Committee (EAC), Sponsor, and Medical Monitor.\n 6.  Receiving stable doses of L Dopa/carbidopa and/or L Dopa/benserazide and/or L Dopa/carbidopa/entacapone (immediate or chronic release) administered at least 4 times per day OR Rytaryâ„¢ administered at least 3 times per day for at least 4 weeks before the initial screening Visit (SV1). Adjunctive PD medication regimens are permitted but must be maintained at a stable dose for at least 4 weeks prior to SV1 with the exception of monoamine oxidase B (MAO B) inhibitors, which must be maintained at a stable level for at least 8 weeks prior to SV1.\n 7.  No planned medication change(s) or surgical intervention anticipated during the course of study.\n 8.  Subjects must experience at least one well defined \"OFF\" episode per day and have a total daily \"OFF\" time duration of > 2 hours during the waking day, based on judgment of physician and subject self assessment.\n 9.  Subject must have predictable morning \"OFF\" periods, based on judgment of physician and subject self assessment.\n 10. Subject, and where appropriate caregiver, must be trained in completing the home dosing diaries and able to recognize \"ON\" and \"OFF\" states.\n 11. Stage III or less on the modified Hoehn and Yahr scale in the \"ON\" state.\n 12. Mini-Mental State Examination (MMSE) score > 25.\n 13. Female subject of childbearing potential and male subject with female partner of childbearing potential must agree to either remain abstinent or use adequate and reliable contraception throughout the study and for at least 7 days after the last dose of study drug has been taken. Note: Continued use of adequate and reliable contraception is recommended through 30 days after study completion.\n 14. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study related procedures to complete the study.\n 15. Must be approved as a satisfactory candidate by the Enrollment Adjudication Committee (EAC), Medical Monitor, and Sponsor.\n\n","\n\n 1.  Atypical or secondary parkinsonism.\n 2.  Major focal brain disorders including malignancy or stroke.\n 3.  Prior treatment with any of the following: a neurosurgical procedure for PD; continuous subcutaneous (subcutaneous) apomorphine infusion; subcutaneous (subcutaneous) apomorphine injection; Duodopa/Duopa; or APL-130277.\n 4.  Contraindications to domperidone, subcutaneous apomorphine, or hypersensitivity to apomorphine hydrochloride or any of the ingredients of subcutaneous apomorphine (notably sodium metabisulfite).\n 5.  Female who is pregnant or lactating.\n 6.  Participation in an interventional clinical study and/or receipt of any investigational (ie, unapproved) medication within 30 days prior to SV1.\n 7.  Currently taking selective 5HT3 antagonists (ie, ondansetron, granisetron, dolasetron, palonosetron, alosetron), dopamine antagonists (excluding quetiapine or clozapine) or dopamine depleting agents. Subjects receiving anti depressants must be on a stable daily dose for at least 8 weeks prior to SV1.\n 8.  The subject has a current diagnosis or history of substance abuse (excluding nicotine and caffeine) or alcohol abuse (in the opinion of the investigator) < 6 months prior to SV1.\n 9.  The recreational use of cannabinoids and hallucinogenic are excluded, as well any use of a sublingual formulation of any drug.\n 10. Subject has a history of malignancy within 5 years prior to SV1, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.\n 11. Subject has a clinically significant abnormality on screening evaluation including physical examination, vital signs, electrocardiogram (ECG), or laboratory tests that the Investigator considers to be inappropriate to allow participation in the study.\n 12. Subject has screening laboratory test results of: blood urea nitrogen (BUN) value â‰¥ 1.5 times the upper limit of normal (ULN) for the reference range; serum creatinine > 1.5 times the ULN for the reference range; or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value â‰¥ 2 times the ULN for the reference laboratory.\n 13. Subject has random (non-fasting) screening glucose of â‰¥ 200 mg/dL (11.1 mmol/L) or HbA1c > 7.0%.\n 14. Subjects with type 1 diabetes, or insulin dependent diabetics are excluded. Subjects with type 2 diabetes are eligible for study inclusion if the following conditions are met: * Subject's screening glucose is < 200 mg/dL (11.1 mmol/L). Note: Subjects with random (non fasting) blood glucose at screening â‰¥ 200 mg/dL (11.1 mmol/L) must be retested in a fasted state; and\n      * Subject's hemoglobin A1c (HbA1c) â‰¤ 7.0%; and\n      * If the subject is currently being treated with oral anti-diabetic medication(s), the dose must have been stable for at least 4 weeks prior to SV1. Such medication may be adjusted or discontinued during the study, as clinically indicated.\n     \n     \n 15. The subject's screening ECG results of corrected QT interval using Fridericia's formula (QTcF) â‰¥ 450 msec for male subjects or â‰¥ 470 msec for female subjects. Eligibility will be based on the core laboratory ECG interpretation report.\n 16. Subject has a positive screening laboratory test result for human immunodeficiency virus (HIV).\n 17. Subject has a positive screening laboratory test result for hepatitis B surface antigen or hepatitis C antibodies and has liver function test results at screening above the ULN for the reference laboratory.\n 18. Subject has any other medical disorder that, in the opinion of the Investigator, could interfere with the subject's participation in the study.\n 19. Subject has major psychiatric disorder(s), including but not limited to: bipolar disorder, psychosis (eg, Parkinson's Disease Psychosis), major depressive episode, or any disorder that, in the opinion of the Investigator, would require treatment that could make study participation unsafe or make treatment compliance difficult.\n 20. History of clinically significant impulse control disorder(s).\n 21. History of symptomatic orthostatic hypotension requiring medication.\n 22. History of severe dyskinesia based on a score of 4 on the MDS-UPDRS Part IV.\n 23. Dementia that precludes providing informed consent or would interfere with participation in the study.\n 24. Current/recent suicidal ideation as evidenced by answering \"yes\" to \"Suicidal Ideation\" item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) on the C-SSRS assessment at screening (using the \"screening /Baseline Version\" scale, in the past 12 months) or attempted suicide within the last 5 years.\n 25. Presence of canker or mouth sores in the 30 days prior to SV1, or other clinically significant oral pathology in the opinion of the Investigator. The Investigator should follow-up with an appropriate specialist on any finding, if indicated, before enrolling a subject into the study","MAOB","monoamine oxidase B","Gene","Prostate","Actual","2018-01-05","Actual","Anticipated","2020-05-31","Anticipated","2019-02-01","2018-01-02","2018-01-02","2019-02-05","No","Parkinson's Disease\n\"Off\" Episodes\nmotor fluctuations associated with Parkinson's Disease","Interventional","Treatment","Crossover Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":4},"Yes",{"$nulls":12},"2016-003456-70","EudraCT Number","change from pre-dose to 90 minutes post-dose in MDS UPDRS Part III score after 4 weeks of dosing in each crossover period (assessed by the blinded-rater in-clinic at Visit 3 and Visit 6 of PART B).","Week 4",null,"Durability of effect, defined as an Investigator confirmed full \"ON\" within 30 minutes post dose and at 90 minutes post-dose, after 4 weeks of dosing in each crossover period (assessed by the blinded-rater in-clinic at Visit 3 and Visit 6 of PART B).|Subject preference for treatment regimen as measured by the Subject Preference Visual Analog Scale (VAS) after the subject has completed both APL 130277 and sc apomorphine treatment regimens (assessed in-clinic at Visit 6 of PART B).|Per the Expanded Home Dosing Diary, percent of \"ON\" episodes without troublesome dyskinesia based on the 3 consecutive days prior to Visit 2, Visit 3, Visit 5, and Visit 6.|Subject confirmed durability of effect, defined as subject confirmed full \"ON\" within 30 minutes post-dose and at 90 minutes post-dose, after 4 weeks of dosing in each crossover period (assessed in-clinic at Visit 3 and Visit 6 of PART B).|Patient Global Impression of Change (PGI-C): Subject improvement of \"OFF\" episodes, defined as very much better, much better or a little better after 4 weeks of dosing in each crossover period (assessed in-clinic at Visit 3 and Visit 6 of PART B).","Week 4|with a recorded range of -50 to 50. Negative values indicate preference for SC treatment, and the more negative the value, the stronger is the preference for SC compared to APL treatment. Positive values indicate preference for APL treatment, and the more positive the value, the stronger is the preference for APL compared to SC treatment. A value of 0 indicates no preference of one treatment over the other.","Week 4","clinicaltrialdisclosure@sunovion.com","CNS Medical Director","1-866-503-6351","Innsbruck, Austria, A-6020|Marseille, France, 13385|Beelitz-Heilstatten, Germany, 14547|Cassino, Italy, 03043|Barcelona, Spain, 08036|London, United Kingdom, Se5 9Rs",null,"Austria|France|Germany|Italy|Spain|United Kingdom","Medical University Innsbruck, Neurolgy Dept|Hopital La Timone, Neurologie Et Pathologie Due Mouvement|Klinken Beelitz Gmbh Neurologisches Fachkrankenhaus Fur Bewegungsstorungen/Parkinson|San Raffaele Cassino|Hospital Clinic De Barcelona|King's College Hospital Nhs Foundation Trust",{"$nulls":3},"CNS Medical Director","2019-02-05","2020-05-25T16:35:26.961","2020-05-26T17:10:42.972","NCT03391882"]
["5ecbf3ce11702c1b1b9169d1","NCT03391882","2019-02-08","Sunovion","SEPR","Recruiting","A Study of an Investigational Drug to See How it Affects the People With Parkinson's Disease Complicated by Motor Fluctuations (\"OFF\" Episodes) Compared to an Approved Drug Used to Treat People With Parkinson's Disease Complicated by Motor Fluctuations (\"OFF\" Episodes)","Apomorphine","DS Agonist","No",null,"No",null,"Phase 3",2,106,"Anticipated","2018-12-19","2020-05-24",{"$nulls":5},"A study of an investigational drug to see how it affects the people with Parkinson's Disease complicated by motor fluctuations (\"OFF\" Episodes) compared to an approved drug used to treat people with Parkinson's Disease complicated by motor fluctuations (\"OFF\" Episodes)","An Open-Label, Randomized, Crossover Trial utilizing a Single-Blinded Rater to evaluate APL-130277 compared to s.c. Apomorphine in Levodopa Responsive Subjects with Parkinson's Disease Complicated by Motor Fluctuations.\n\nPART A consists of an open label, crossover titration phase where eligible subjects will be randomized to 1 of 2 treatment sequences in a 1:1 ratio to Sublingual APL 130277 followed by subcutaneous apomorphine or subcutaneous apomorphine followed by sublingual APL 130277. Subjects will undergo dose titration with the first study treatment (APL 130277 or sc apomorphine) to tolerance and effect, ie, the tolerable dose that turns the subject from the practically defined \"OFF\" state to the full \"ON\" state as determined by both the Investigator and subject. The subject will then be crossed over to the other study treatment (APL 130277 or subcutaneous apomorphine) and similarly titrated to tolerance and effect. These determined doses of APL 130277 and subcutaneous apomorphine will be used during PART B.\n\nPART B consists of an open-label, crossover treatment period where subjects will be randomized to one of the study treatment for 4 weeks, then be crossed over to the other study treatment (APL-130277 or sc apomorphine) for additional 4-weeks of open-label treatment. Subjects return to the clinic for safety and efficacy assessments throughout the treatment period.\n\nThis study is designed to test the superiority of sublingually administered APL-130277 against subcutaneously injected apomorphine (APO-go) for the treatment of \"OFF\" episodes in patients with Parkinson's Disease, as measured by the change from pre-dose to 90 minutes post-dose in MDS UPDRS Part III score in Part B after 4 weeks of dosing in each crossover period.","An Open-Label, Randomized, Crossover Trial Utilizing a Single-Blinded Rater to Evaluate APL-130277 Compared to Subcutaneous Apomorphine in Levodopa Responsive Subjects With Parkinson's Disease Complicated by Motor Fluctuations","CTH-302","Motor OFF Episodes Associated With Parkinson's Disease","Parkinson Disease","Central Nervous System Diseases","Central Nervous System","Experimental|Active Comparator","APL-130277|subcutaneous apomorphine","APL-130277: Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A|subcutaneous apomorphine , Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A","Drug","APL-130277|subcutaneous apomorphine","APL-130277: Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A|subcutaneous apomorphine Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A","Apomorphine Hydrochloride|APO-goÂ®","APL-130277|subcutaneous apomorphine","\n\n 1.  The subject (and caregiver, if applicable) must be fully informed of and understand the objectives, procedures, and possible benefits and risks of the study, and give written informed consent prior to performing any study related activities.\n 2.  Male or female â‰¥ 18 years of age.\n 3.  Clinical diagnosis of Idiopathic PD, consistent with UK Brain Bank Criteria (excluding the \"more than one affected relative\" criterion).\n 4.  Clinically meaningful response to levodopa (L-Dopa), as determined by the Investigator.\n 5.  Subjects at screening must demonstrate an adequate L-Dopa response on the MDS UPDRS Part III in the \"ON\" state compared to the MDS UPDRS Part III in the \"OFF\" state and on the Hoehn and Yahr, as determined during the review by Enrollment Adjudication Committee (EAC), Sponsor, and Medical Monitor.\n 6.  Receiving stable doses of L Dopa/carbidopa and/or L Dopa/benserazide and/or L Dopa/carbidopa/entacapone (immediate or chronic release) administered at least 4 times per day OR Rytaryâ„¢ administered at least 3 times per day for at least 4 weeks before the initial screening Visit (SV1). Adjunctive PD medication regimens are permitted but must be maintained at a stable dose for at least 4 weeks prior to SV1 with the exception of monoamine oxidase B (MAO B) inhibitors, which must be maintained at a stable level for at least 8 weeks prior to SV1.\n 7.  No planned medication change(s) or surgical intervention anticipated during the course of study.\n 8.  Subjects must experience at least one well defined \"OFF\" episode per day and have a total daily \"OFF\" time duration of > 2 hours during the waking day, based on judgment of physician and subject self assessment.\n 9.  Subject must have predictable morning \"OFF\" periods, based on judgment of physician and subject self assessment.\n 10. Subject, and where appropriate caregiver, must be trained in completing the home dosing diaries and able to recognize \"ON\" and \"OFF\" states.\n 11. Stage III or less on the modified Hoehn and Yahr scale in the \"ON\" state.\n 12. Mini-Mental State Examination (MMSE) score > 25.\n 13. Female subject of childbearing potential and male subject with female partner of childbearing potential must agree to either remain abstinent or use adequate and reliable contraception throughout the study and for at least 7 days after the last dose of study drug has been taken. Note: Continued use of adequate and reliable contraception is recommended through 30 days after study completion.\n 14. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study related procedures to complete the study.\n 15. Must be approved as a satisfactory candidate by the Enrollment Adjudication Committee (EAC), Medical Monitor, and Sponsor.\n\n","\n\n 1.  Atypical or secondary parkinsonism.\n 2.  Major focal brain disorders including malignancy or stroke.\n 3.  Prior treatment with any of the following: a neurosurgical procedure for PD; continuous subcutaneous (subcutaneous) apomorphine infusion; subcutaneous (subcutaneous) apomorphine injection; Duodopa/Duopa; or APL-130277.\n 4.  Contraindications to domperidone, subcutaneous apomorphine, or hypersensitivity to apomorphine hydrochloride or any of the ingredients of subcutaneous apomorphine (notably sodium metabisulfite).\n 5.  Female who is pregnant or lactating.\n 6.  Participation in an interventional clinical study and/or receipt of any investigational (ie, unapproved) medication within 30 days prior to SV1.\n 7.  Currently taking selective 5HT3 antagonists (ie, ondansetron, granisetron, dolasetron, palonosetron, alosetron), dopamine antagonists (excluding quetiapine or clozapine) or dopamine depleting agents. Subjects receiving anti depressants must be on a stable daily dose for at least 8 weeks prior to SV1.\n 8.  The subject has a current diagnosis or history of substance abuse (excluding nicotine and caffeine) or alcohol abuse (in the opinion of the investigator) < 6 months prior to SV1.\n 9.  The recreational use of cannabinoids and hallucinogenic are excluded, as well any use of a sublingual formulation of any drug.\n 10. Subject has a history of malignancy within 5 years prior to SV1, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.\n 11. Subject has a clinically significant abnormality on screening evaluation including physical examination, vital signs, electrocardiogram (ECG), or laboratory tests that the Investigator considers to be inappropriate to allow participation in the study.\n 12. Subject has screening laboratory test results of: blood urea nitrogen (BUN) value â‰¥ 1.5 times the upper limit of normal (ULN) for the reference range; serum creatinine > 1.5 times the ULN for the reference range; or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value â‰¥ 2 times the ULN for the reference laboratory.\n 13. Subject has random (non-fasting) screening glucose of â‰¥ 200 mg/dL (11.1 mmol/L) or HbA1c > 7.0%.\n 14. Subjects with type 1 diabetes, or insulin dependent diabetics are excluded. Subjects with type 2 diabetes are eligible for study inclusion if the following conditions are met: * Subject's screening glucose is < 200 mg/dL (11.1 mmol/L). Note: Subjects with random (non fasting) blood glucose at screening â‰¥ 200 mg/dL (11.1 mmol/L) must be retested in a fasted state; and\n      * Subject's hemoglobin A1c (HbA1c) â‰¤ 7.0%; and\n      * If the subject is currently being treated with oral anti-diabetic medication(s), the dose must have been stable for at least 4 weeks prior to SV1. Such medication may be adjusted or discontinued during the study, as clinically indicated.\n     \n     \n 15. The subject's screening ECG results of corrected QT interval using Fridericia's formula (QTcF) â‰¥ 450 msec for male subjects or â‰¥ 470 msec for female subjects. Eligibility will be based on the core laboratory ECG interpretation report.\n 16. Subject has a positive screening laboratory test result for human immunodeficiency virus (HIV).\n 17. Subject has a positive screening laboratory test result for hepatitis B surface antigen or hepatitis C antibodies and has liver function test results at screening above the ULN for the reference laboratory.\n 18. Subject has any other medical disorder that, in the opinion of the Investigator, could interfere with the subject's participation in the study.\n 19. Subject has major psychiatric disorder(s), including but not limited to: bipolar disorder, psychosis (eg, Parkinson's Disease Psychosis), major depressive episode, or any disorder that, in the opinion of the Investigator, would require treatment that could make study participation unsafe or make treatment compliance difficult.\n 20. History of clinically significant impulse control disorder(s).\n 21. History of symptomatic orthostatic hypotension requiring medication.\n 22. History of severe dyskinesia based on a score of 4 on the MDS-UPDRS Part IV.\n 23. Dementia that precludes providing informed consent or would interfere with participation in the study.\n 24. Current/recent suicidal ideation as evidenced by answering \"yes\" to \"Suicidal Ideation\" item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) on the C-SSRS assessment at screening (using the \"screening /Baseline Version\" scale, in the past 12 months) or attempted suicide within the last 5 years.\n 25. Presence of canker or mouth sores in the 30 days prior to SV1, or other clinically significant oral pathology in the opinion of the Investigator. The Investigator should follow-up with an appropriate specialist on any finding, if indicated, before enrolling a subject into the study","MAOB","monoamine oxidase B","Gene","Prostate","Actual","2018-01-05","Actual","Anticipated","2020-05-31","Anticipated","2019-02-01","2018-01-02","2018-01-02","2019-02-07","No","Parkinson's Disease\n\"Off\" Episodes\nmotor fluctuations associated with Parkinson's Disease","Interventional","Treatment","Crossover Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":4},"Yes",{"$nulls":12},"2016-003456-70","EudraCT Number","change from pre-dose to 90 minutes post-dose in MDS UPDRS Part III score after 4 weeks of dosing in each crossover period (assessed by the blinded-rater in-clinic at Visit 3 and Visit 6 of PART B).","Week 4",null,"Durability of effect, defined as an Investigator confirmed full \"ON\" within 30 minutes post dose and at 90 minutes post-dose, after 4 weeks of dosing in each crossover period (assessed by the blinded-rater in-clinic at Visit 3 and Visit 6 of PART B).|Subject preference for treatment regimen as measured by the Subject Preference Visual Analog Scale (VAS) after the subject has completed both APL 130277 and sc apomorphine treatment regimens (assessed in-clinic at Visit 6 of PART B).|Per the Expanded Home Dosing Diary, percent of \"ON\" episodes without troublesome dyskinesia based on the 3 consecutive days prior to Visit 2, Visit 3, Visit 5, and Visit 6.|Subject confirmed durability of effect, defined as subject confirmed full \"ON\" within 30 minutes post-dose and at 90 minutes post-dose, after 4 weeks of dosing in each crossover period (assessed in-clinic at Visit 3 and Visit 6 of PART B).|Patient Global Impression of Change (PGI-C): Subject improvement of \"OFF\" episodes, defined as very much better, much better or a little better after 4 weeks of dosing in each crossover period (assessed in-clinic at Visit 3 and Visit 6 of PART B).","Week 4|with a recorded range of -50 to 50. Negative values indicate preference for SC treatment, and the more negative the value, the stronger is the preference for SC compared to APL treatment. Positive values indicate preference for APL treatment, and the more positive the value, the stronger is the preference for APL compared to SC treatment. A value of 0 indicates no preference of one treatment over the other.","Week 4","clinicaltrialdisclosure@sunovion.com","CNS Medical Director","1-866-503-6351","Innsbruck, Austria, A-6020|Marseille, France, 13385|Beelitz-Heilstatten, Germany, 14547|Cassino, Italy, 03043|Barcelona, Spain, 08036|London, United Kingdom, Se5 9Rs",null,"Austria|France|Germany|Italy|Spain|United Kingdom","Medical University Innsbruck, Neurolgy Dept|Hopital La Timone, Neurologie Et Pathologie Due Mouvement|Klinken Beelitz Gmbh Neurologisches Fachkrankenhaus Fur Bewegungsstorungen/Parkinson|San Raffaele Cassino|Hospital Clinic De Barcelona|King's College Hospital Nhs Foundation Trust",{"$nulls":3},"CNS Medical Director","2019-02-07","2020-05-25T16:35:26.840","2020-05-26T17:10:42.972","NCT03391882"]
["5ecbf3cefeab101b155307ed","NCT03391882","2019-02-20","Sunovion","SEPR","Recruiting","A Study of an Investigational Drug to See How it Affects the People With Parkinson's Disease Complicated by Motor Fluctuations (\"OFF\" Episodes) Compared to an Approved Drug Used to Treat People With Parkinson's Disease Complicated by Motor Fluctuations (\"OFF\" Episodes)","Apomorphine","DS Agonist","No",null,"No",null,"Phase 3",2,106,"Anticipated","2018-12-19","2020-05-24",{"$nulls":5},"A study of an investigational drug to see how it affects the people with Parkinson's Disease complicated by motor fluctuations (\"OFF\" Episodes) compared to an approved drug used to treat people with Parkinson's Disease complicated by motor fluctuations (\"OFF\" Episodes)","An Open-Label, Randomized, Crossover Trial utilizing a Single-Blinded Rater to evaluate APL-130277 compared to s.c. Apomorphine in Levodopa Responsive Subjects with Parkinson's Disease Complicated by Motor Fluctuations.\n\nPART A consists of an open label, crossover titration phase where eligible subjects will be randomized to 1 of 2 treatment sequences in a 1:1 ratio to Sublingual APL 130277 followed by subcutaneous apomorphine or subcutaneous apomorphine followed by sublingual APL 130277. Subjects will undergo dose titration with the first study treatment (APL 130277 or sc apomorphine) to tolerance and effect, ie, the tolerable dose that turns the subject from the practically defined \"OFF\" state to the full \"ON\" state as determined by both the Investigator and subject. The subject will then be crossed over to the other study treatment (APL 130277 or subcutaneous apomorphine) and similarly titrated to tolerance and effect. These determined doses of APL 130277 and subcutaneous apomorphine will be used during PART B.\n\nPART B consists of an open-label, crossover treatment period where subjects will be randomized to one of the study treatment for 4 weeks, then be crossed over to the other study treatment (APL-130277 or sc apomorphine) for additional 4-weeks of open-label treatment. Subjects return to the clinic for safety and efficacy assessments throughout the treatment period.\n\nThis study is designed to test the superiority of sublingually administered APL-130277 against subcutaneously injected apomorphine (APO-go) for the treatment of \"OFF\" episodes in patients with Parkinson's Disease, as measured by the change from pre-dose to 90 minutes post-dose in MDS UPDRS Part III score in Part B after 4 weeks of dosing in each crossover period.","An Open-Label, Randomized, Crossover Trial Utilizing a Single-Blinded Rater to Evaluate APL-130277 Compared to Subcutaneous Apomorphine in Levodopa Responsive Subjects With Parkinson's Disease Complicated by Motor Fluctuations","CTH-302","Motor OFF Episodes Associated With Parkinson's Disease","Parkinson Disease","Central Nervous System Diseases","Central Nervous System","Experimental|Active Comparator","APL-130277|subcutaneous apomorphine","APL-130277: Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A|subcutaneous apomorphine , Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A","Drug","APL-130277|subcutaneous apomorphine","APL-130277: Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A|subcutaneous apomorphine Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A","Apomorphine Hydrochloride|APO-goÂ®","APL-130277|subcutaneous apomorphine","\n\n 1.  The subject (and caregiver, if applicable) must be fully informed of and understand the objectives, procedures, and possible benefits and risks of the study, and give written informed consent prior to performing any study related activities.\n 2.  Male or female â‰¥ 18 years of age.\n 3.  Clinical diagnosis of Idiopathic PD, consistent with UK Brain Bank Criteria (excluding the \"more than one affected relative\" criterion).\n 4.  Clinically meaningful response to levodopa (L-Dopa), as determined by the Investigator.\n 5.  Subjects at screening must demonstrate an adequate L-Dopa response on the MDS UPDRS Part III in the \"ON\" state compared to the MDS UPDRS Part III in the \"OFF\" state and on the Hoehn and Yahr, as determined during the review by Enrollment Adjudication Committee (EAC), Sponsor, and Medical Monitor.\n 6.  Receiving stable doses of L Dopa/carbidopa and/or L Dopa/benserazide and/or L Dopa/carbidopa/entacapone (immediate or chronic release) administered at least 4 times per day OR Rytaryâ„¢ administered at least 3 times per day for at least 4 weeks before the initial screening Visit (SV1). Adjunctive PD medication regimens are permitted but must be maintained at a stable dose for at least 4 weeks prior to SV1 with the exception of monoamine oxidase B (MAO B) inhibitors, which must be maintained at a stable level for at least 8 weeks prior to SV1.\n 7.  No planned medication change(s) or surgical intervention anticipated during the course of study.\n 8.  Subjects must experience at least one well defined \"OFF\" episode per day and have a total daily \"OFF\" time duration of > 2 hours during the waking day, based on judgment of physician and subject self assessment.\n 9.  Subject must have predictable morning \"OFF\" periods, based on judgment of physician and subject self assessment.\n 10. Subject, and where appropriate caregiver, must be trained in completing the home dosing diaries and able to recognize \"ON\" and \"OFF\" states.\n 11. Stage III or less on the modified Hoehn and Yahr scale in the \"ON\" state.\n 12. Mini-Mental State Examination (MMSE) score > 25.\n 13. Female subject of childbearing potential and male subject with female partner of childbearing potential must agree to either remain abstinent or use adequate and reliable contraception throughout the study and for at least 7 days after the last dose of study drug has been taken. Note: Continued use of adequate and reliable contraception is recommended through 30 days after study completion.\n 14. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study related procedures to complete the study.\n 15. Must be approved as a satisfactory candidate by the Enrollment Adjudication Committee (EAC), Medical Monitor, and Sponsor.\n\n","\n\n 1.  Atypical or secondary parkinsonism.\n 2.  Major focal brain disorders including malignancy or stroke.\n 3.  Prior treatment with any of the following: a neurosurgical procedure for PD; continuous subcutaneous (subcutaneous) apomorphine infusion; subcutaneous (subcutaneous) apomorphine injection; Duodopa/Duopa; or APL-130277.\n 4.  Contraindications to domperidone, subcutaneous apomorphine, or hypersensitivity to apomorphine hydrochloride or any of the ingredients of subcutaneous apomorphine (notably sodium metabisulfite).\n 5.  Female who is pregnant or lactating.\n 6.  Participation in an interventional clinical study and/or receipt of any investigational (ie, unapproved) medication within 30 days prior to SV1.\n 7.  Currently taking selective 5HT3 antagonists (ie, ondansetron, granisetron, dolasetron, palonosetron, alosetron), dopamine antagonists (excluding quetiapine or clozapine) or dopamine depleting agents. Subjects receiving anti depressants must be on a stable daily dose for at least 8 weeks prior to SV1.\n 8.  The subject has a current diagnosis or history of substance abuse (excluding nicotine and caffeine) or alcohol abuse (in the opinion of the investigator) < 6 months prior to SV1.\n 9.  The recreational use of cannabinoids and hallucinogenic are excluded, as well any use of a sublingual formulation of any drug.\n 10. Subject has a history of malignancy within 5 years prior to SV1, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.\n 11. Subject has a clinically significant abnormality on screening evaluation including physical examination, vital signs, electrocardiogram (ECG), or laboratory tests that the Investigator considers to be inappropriate to allow participation in the study.\n 12. Subject has screening laboratory test results of: blood urea nitrogen (BUN) value â‰¥ 1.5 times the upper limit of normal (ULN) for the reference range; serum creatinine > 1.5 times the ULN for the reference range; or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value â‰¥ 2 times the ULN for the reference laboratory.\n 13. Subject has random (non-fasting) screening glucose of â‰¥ 200 mg/dL (11.1 mmol/L) or HbA1c > 7.0%.\n 14. Subjects with type 1 diabetes, or insulin dependent diabetics are excluded. Subjects with type 2 diabetes are eligible for study inclusion if the following conditions are met: * Subject's screening glucose is < 200 mg/dL (11.1 mmol/L). Note: Subjects with random (non fasting) blood glucose at screening â‰¥ 200 mg/dL (11.1 mmol/L) must be retested in a fasted state; and\n      * Subject's hemoglobin A1c (HbA1c) â‰¤ 7.0%; and\n      * If the subject is currently being treated with oral anti-diabetic medication(s), the dose must have been stable for at least 4 weeks prior to SV1. Such medication may be adjusted or discontinued during the study, as clinically indicated.\n     \n     \n 15. The subject's screening ECG results of corrected QT interval using Fridericia's formula (QTcF) â‰¥ 450 msec for male subjects or â‰¥ 470 msec for female subjects. Eligibility will be based on the core laboratory ECG interpretation report.\n 16. Subject has a positive screening laboratory test result for human immunodeficiency virus (HIV).\n 17. Subject has a positive screening laboratory test result for hepatitis B surface antigen or hepatitis C antibodies and has liver function test results at screening above the ULN for the reference laboratory.\n 18. Subject has any other medical disorder that, in the opinion of the Investigator, could interfere with the subject's participation in the study.\n 19. Subject has major psychiatric disorder(s), including but not limited to: bipolar disorder, psychosis (eg, Parkinson's Disease Psychosis), major depressive episode, or any disorder that, in the opinion of the Investigator, would require treatment that could make study participation unsafe or make treatment compliance difficult.\n 20. History of clinically significant impulse control disorder(s).\n 21. History of symptomatic orthostatic hypotension requiring medication.\n 22. History of severe dyskinesia based on a score of 4 on the MDS-UPDRS Part IV.\n 23. Dementia that precludes providing informed consent or would interfere with participation in the study.\n 24. Current/recent suicidal ideation as evidenced by answering \"yes\" to \"Suicidal Ideation\" item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) on the C-SSRS assessment at screening (using the \"screening /Baseline Version\" scale, in the past 12 months) or attempted suicide within the last 5 years.\n 25. Presence of canker or mouth sores in the 30 days prior to SV1, or other clinically significant oral pathology in the opinion of the Investigator. The Investigator should follow-up with an appropriate specialist on any finding, if indicated, before enrolling a subject into the study","MAOB","monoamine oxidase B","Gene","Prostate","Actual","2018-01-05","Actual","Anticipated","2020-05-31","Anticipated","2019-02-01","2018-01-02","2018-01-02","2019-02-19","No","Parkinson's Disease\n\"Off\" Episodes\nmotor fluctuations associated with Parkinson's Disease","Interventional","Treatment","Crossover Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":4},"Yes",{"$nulls":12},"2016-003456-70","EudraCT Number","change from pre-dose to 90 minutes post-dose in MDS UPDRS Part III score after 4 weeks of dosing in each crossover period (assessed by the blinded-rater in-clinic at Visit 3 and Visit 6 of PART B).","Week 4",null,"Durability of effect, defined as an Investigator confirmed full \"ON\" within 30 minutes post dose and at 90 minutes post-dose, after 4 weeks of dosing in each crossover period (assessed by the blinded-rater in-clinic at Visit 3 and Visit 6 of PART B).|Subject preference for treatment regimen as measured by the Subject Preference Visual Analog Scale (VAS) after the subject has completed both APL 130277 and sc apomorphine treatment regimens (assessed in-clinic at Visit 6 of PART B).|Per the Expanded Home Dosing Diary, percent of \"ON\" episodes without troublesome dyskinesia based on the 3 consecutive days prior to Visit 2, Visit 3, Visit 5, and Visit 6.|Subject confirmed durability of effect, defined as subject confirmed full \"ON\" within 30 minutes post-dose and at 90 minutes post-dose, after 4 weeks of dosing in each crossover period (assessed in-clinic at Visit 3 and Visit 6 of PART B).|Patient Global Impression of Change (PGI-C): Subject improvement of \"OFF\" episodes, defined as very much better, much better or a little better after 4 weeks of dosing in each crossover period (assessed in-clinic at Visit 3 and Visit 6 of PART B).","Week 4|with a recorded range of -50 to 50. Negative values indicate preference for SC treatment, and the more negative the value, the stronger is the preference for SC compared to APL treatment. Positive values indicate preference for APL treatment, and the more positive the value, the stronger is the preference for APL compared to SC treatment. A value of 0 indicates no preference of one treatment over the other.","Week 4","clinicaltrialdisclosure@sunovion.com","CNS Medical Director","1-866-503-6351","Innsbruck, Austria, A-6020|Marseille, France, 13385|Beelitz-Heilstatten, Germany, 14547|Cassino, Italy, 03043|Barcelona, Spain, 08036|London, United Kingdom, Se5 9Rs",null,"Austria|France|Germany|Italy|Spain|United Kingdom","Medical University Innsbruck, Neurolgy Dept|Hopital La Timone, Neurologie Et Pathologie Due Mouvement|Klinken Beelitz Gmbh Neurologisches Fachkrankenhaus Fur Bewegungsstorungen/Parkinson|San Raffaele Cassino|Hospital Clinic De Barcelona|King's College Hospital Nhs Foundation Trust",{"$nulls":3},"CNS Medical Director","2019-02-19","2020-05-25T16:35:26.781","2020-05-26T17:10:42.972","NCT03391882"]
["5ecbf3cf307e3d1b1f8d9c4e","NCT03391882","2019-03-13","Sunovion","SEPR","Recruiting","A Study of an Investigational Drug to See How it Affects the People With Parkinson's Disease Complicated by Motor Fluctuations (\"OFF\" Episodes) Compared to an Approved Drug Used to Treat People With Parkinson's Disease Complicated by Motor Fluctuations (\"OFF\" Episodes)","Apomorphine","DS Agonist","No",null,"No",null,"Phase 3",2,106,"Anticipated","2018-12-19","2020-05-24",{"$nulls":5},"A study of an investigational drug to see how it affects the people with Parkinson's Disease complicated by motor fluctuations (\"OFF\" Episodes) compared to an approved drug used to treat people with Parkinson's Disease complicated by motor fluctuations (\"OFF\" Episodes)","An Open-Label, Randomized, Crossover Trial utilizing a Single-Blinded Rater to evaluate APL-130277 compared to s.c. Apomorphine in Levodopa Responsive Subjects with Parkinson's Disease Complicated by Motor Fluctuations.\n\nPART A consists of an open label, crossover titration phase where eligible subjects will be randomized to 1 of 2 treatment sequences in a 1:1 ratio to Sublingual APL 130277 followed by subcutaneous apomorphine or subcutaneous apomorphine followed by sublingual APL 130277. Subjects will undergo dose titration with the first study treatment (APL 130277 or sc apomorphine) to tolerance and effect, ie, the tolerable dose that turns the subject from the practically defined \"OFF\" state to the full \"ON\" state as determined by both the Investigator and subject. The subject will then be crossed over to the other study treatment (APL 130277 or subcutaneous apomorphine) and similarly titrated to tolerance and effect. These determined doses of APL 130277 and subcutaneous apomorphine will be used during PART B.\n\nPART B consists of an open-label, crossover treatment period where subjects will be randomized to one of the study treatment for 4 weeks, then be crossed over to the other study treatment (APL-130277 or sc apomorphine) for additional 4-weeks of open-label treatment. Subjects return to the clinic for safety and efficacy assessments throughout the treatment period.\n\nThis study is designed to test the superiority of sublingually administered APL-130277 against subcutaneously injected apomorphine (APO-go) for the treatment of \"OFF\" episodes in patients with Parkinson's Disease, as measured by the change from pre-dose to 90 minutes post-dose in MDS UPDRS Part III score in Part B after 4 weeks of dosing in each crossover period.","An Open-Label, Randomized, Crossover Trial Utilizing a Single-Blinded Rater to Evaluate APL-130277 Compared to Subcutaneous Apomorphine in Levodopa Responsive Subjects With Parkinson's Disease Complicated by Motor Fluctuations","CTH-302","Motor OFF Episodes Associated With Parkinson's Disease","Parkinson Disease","Central Nervous System Diseases","Central Nervous System","Experimental|Active Comparator","APL-130277|subcutaneous apomorphine","APL-130277: Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A|subcutaneous apomorphine , Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A","Drug","APL-130277|subcutaneous apomorphine","APL-130277: Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A|subcutaneous apomorphine Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A","Apomorphine Hydrochloride|APO-goÂ®","APL-130277|subcutaneous apomorphine","\n\n 1.  The subject (and caregiver, if applicable) must be fully informed of and understand the objectives, procedures, and possible benefits and risks of the study, and give written informed consent prior to performing any study related activities.\n 2.  Male or female â‰¥ 18 years of age.\n 3.  Clinical diagnosis of Idiopathic PD, consistent with UK Brain Bank Criteria (excluding the \"more than one affected relative\" criterion).\n 4.  Clinically meaningful response to levodopa (L-Dopa), as determined by the Investigator.\n 5.  Subjects at screening must demonstrate an adequate L-Dopa response on the MDS UPDRS Part III in the \"ON\" state compared to the MDS UPDRS Part III in the \"OFF\" state and on the Hoehn and Yahr, as determined during the review by Enrollment Adjudication Committee (EAC), Sponsor, and Medical Monitor.\n 6.  Receiving stable doses of L Dopa/carbidopa and/or L Dopa/benserazide and/or L Dopa/carbidopa/entacapone (immediate or chronic release) administered at least 4 times per day OR Rytaryâ„¢ administered at least 3 times per day for at least 4 weeks before the initial screening Visit (SV1). Adjunctive PD medication regimens are permitted but must be maintained at a stable dose for at least 4 weeks prior to SV1 with the exception of monoamine oxidase B (MAO B) inhibitors, which must be maintained at a stable level for at least 8 weeks prior to SV1.\n 7.  No planned medication change(s) or surgical intervention anticipated during the course of study.\n 8.  Subjects must experience at least one well defined \"OFF\" episode per day and have a total daily \"OFF\" time duration of > 2 hours during the waking day, based on judgment of physician and subject self assessment.\n 9.  Subject must have predictable morning \"OFF\" periods, based on judgment of physician and subject self assessment.\n 10. Subject, and where appropriate caregiver, must be trained in completing the home dosing diaries and able to recognize \"ON\" and \"OFF\" states.\n 11. Stage III or less on the modified Hoehn and Yahr scale in the \"ON\" state.\n 12. Mini-Mental State Examination (MMSE) score > 25.\n 13. Female subject of childbearing potential and male subject with female partner of childbearing potential must agree to either remain abstinent or use adequate and reliable contraception throughout the study and for at least 7 days after the last dose of study drug has been taken. Note: Continued use of adequate and reliable contraception is recommended through 30 days after study completion.\n 14. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study related procedures to complete the study.\n 15. Must be approved as a satisfactory candidate by the Enrollment Adjudication Committee (EAC), Medical Monitor, and Sponsor.\n\n","\n\n 1.  Atypical or secondary parkinsonism.\n 2.  Major focal brain disorders including malignancy or stroke.\n 3.  Prior treatment with any of the following: a neurosurgical procedure for PD; continuous subcutaneous (subcutaneous) apomorphine infusion; subcutaneous (subcutaneous) apomorphine injection; Duodopa/Duopa; or APL-130277.\n 4.  Contraindications to domperidone, subcutaneous apomorphine, or hypersensitivity to apomorphine hydrochloride or any of the ingredients of subcutaneous apomorphine (notably sodium metabisulfite).\n 5.  Female who is pregnant or lactating.\n 6.  Participation in an interventional clinical study and/or receipt of any investigational (ie, unapproved) medication within 30 days prior to SV1.\n 7.  Currently taking selective 5HT3 antagonists (ie, ondansetron, granisetron, dolasetron, palonosetron, alosetron), dopamine antagonists (excluding quetiapine or clozapine) or dopamine depleting agents. Subjects receiving anti depressants must be on a stable daily dose for at least 8 weeks prior to SV1.\n 8.  The subject has a current diagnosis or history of substance abuse (excluding nicotine and caffeine) or alcohol abuse (in the opinion of the investigator) < 6 months prior to SV1.\n 9.  The recreational use of cannabinoids and hallucinogenic are excluded, as well any use of a sublingual formulation of any drug.\n 10. Subject has a history of malignancy within 5 years prior to SV1, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.\n 11. Subject has a clinically significant abnormality on screening evaluation including physical examination, vital signs, electrocardiogram (ECG), or laboratory tests that the Investigator considers to be inappropriate to allow participation in the study.\n 12. Subject has screening laboratory test results of: blood urea nitrogen (BUN) value â‰¥ 1.5 times the upper limit of normal (ULN) for the reference range; serum creatinine > 1.5 times the ULN for the reference range; or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value â‰¥ 2 times the ULN for the reference laboratory.\n 13. Subject has random (non-fasting) screening glucose of â‰¥ 200 mg/dL (11.1 mmol/L) or HbA1c > 7.0%.\n 14. Subjects with type 1 diabetes, or insulin dependent diabetics are excluded. Subjects with type 2 diabetes are eligible for study inclusion if the following conditions are met: * Subject's screening glucose is < 200 mg/dL (11.1 mmol/L). Note: Subjects with random (non fasting) blood glucose at screening â‰¥ 200 mg/dL (11.1 mmol/L) must be retested in a fasted state; and\n      * Subject's hemoglobin A1c (HbA1c) â‰¤ 7.0%; and\n      * If the subject is currently being treated with oral anti-diabetic medication(s), the dose must have been stable for at least 4 weeks prior to SV1. Such medication may be adjusted or discontinued during the study, as clinically indicated.\n     \n     \n 15. The subject's screening ECG results of corrected QT interval using Fridericia's formula (QTcF) â‰¥ 450 msec for male subjects or â‰¥ 470 msec for female subjects. Eligibility will be based on the core laboratory ECG interpretation report.\n 16. Subject has a positive screening laboratory test result for human immunodeficiency virus (HIV).\n 17. Subject has a positive screening laboratory test result for hepatitis B surface antigen or hepatitis C antibodies and has liver function test results at screening above the ULN for the reference laboratory.\n 18. Subject has any other medical disorder that, in the opinion of the Investigator, could interfere with the subject's participation in the study.\n 19. Subject has major psychiatric disorder(s), including but not limited to: bipolar disorder, psychosis (eg, Parkinson's Disease Psychosis), major depressive episode, or any disorder that, in the opinion of the Investigator, would require treatment that could make study participation unsafe or make treatment compliance difficult.\n 20. History of clinically significant impulse control disorder(s).\n 21. History of symptomatic orthostatic hypotension requiring medication.\n 22. History of severe dyskinesia based on a score of 4 on the MDS-UPDRS Part IV.\n 23. Dementia that precludes providing informed consent or would interfere with participation in the study.\n 24. Current/recent suicidal ideation as evidenced by answering \"yes\" to \"Suicidal Ideation\" item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) on the C-SSRS assessment at screening (using the \"screening /Baseline Version\" scale, in the past 12 months) or attempted suicide within the last 5 years.\n 25. Presence of canker or mouth sores in the 30 days prior to SV1, or other clinically significant oral pathology in the opinion of the Investigator. The Investigator should follow-up with an appropriate specialist on any finding, if indicated, before enrolling a subject into the study","MAOB","monoamine oxidase B","Gene","Prostate","Actual","2018-01-05","Actual","Anticipated","2020-05-31","Anticipated","2019-03-01","2018-01-02","2018-01-02","2019-03-12","No","Parkinson's Disease\n\"Off\" Episodes\nmotor fluctuations associated with Parkinson's Disease","Interventional","Treatment","Crossover Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":4},"Yes",{"$nulls":12},"2016-003456-70","EudraCT Number","change from pre-dose to 90 minutes post-dose in MDS UPDRS Part III score after 4 weeks of dosing in each crossover period (assessed by the blinded-rater in-clinic at Visit 3 and Visit 6 of PART B).","Week 4",null,"Durability of effect, defined as an Investigator confirmed full \"ON\" within 30 minutes post dose and at 90 minutes post-dose, after 4 weeks of dosing in each crossover period (assessed by the blinded-rater in-clinic at Visit 3 and Visit 6 of PART B).|Subject preference for treatment regimen as measured by the Subject Preference Visual Analog Scale (VAS) after the subject has completed both APL 130277 and sc apomorphine treatment regimens (assessed in-clinic at Visit 6 of PART B).|Per the Expanded Home Dosing Diary, percent of \"ON\" episodes without troublesome dyskinesia based on the 3 consecutive days prior to Visit 2, Visit 3, Visit 5, and Visit 6.|Subject confirmed durability of effect, defined as subject confirmed full \"ON\" within 30 minutes post-dose and at 90 minutes post-dose, after 4 weeks of dosing in each crossover period (assessed in-clinic at Visit 3 and Visit 6 of PART B).|Patient Global Impression of Change (PGI-C): Subject improvement of \"OFF\" episodes, defined as very much better, much better or a little better after 4 weeks of dosing in each crossover period (assessed in-clinic at Visit 3 and Visit 6 of PART B).","Week 4|with a recorded range of -50 to 50. Negative values indicate preference for SC treatment, and the more negative the value, the stronger is the preference for SC compared to APL treatment. Positive values indicate preference for APL treatment, and the more positive the value, the stronger is the preference for APL compared to SC treatment. A value of 0 indicates no preference of one treatment over the other.","Week 4","clinicaltrialdisclosure@sunovion.com","CNS Medical Director","1-866-503-6351","Innsbruck, Austria, A-6020|Marseille, France, 13385|Beelitz-Heilstatten, Germany, 14547|Cassino, Italy, 03043|Barcelona, Spain, 08036|London, United Kingdom, Se5 9Rs",null,"Austria|France|Germany|Italy|Spain|United Kingdom","Medical University Innsbruck, Neurolgy Dept|Hopital La Timone, Neurologie Et Pathologie Due Mouvement|Klinken Beelitz Gmbh Neurologisches Fachkrankenhaus Fur Bewegungsstorungen/Parkinson|San Raffaele Cassino|Hospital Clinic De Barcelona|King's College Hospital Nhs Foundation Trust",{"$nulls":3},"CNS Medical Director","2019-03-12","2020-05-25T16:35:27.098","2020-05-26T17:10:42.972","NCT03391882"]
["5ecbf3cfe2561b1b11905cba","NCT03391882","2019-03-26","Sunovion","SEPR","Recruiting","A Study of an Investigational Drug to See How it Affects the People With Parkinson's Disease Complicated by Motor Fluctuations (\"OFF\" Episodes) Compared to an Approved Drug Used to Treat People With Parkinson's Disease Complicated by Motor Fluctuations (\"OFF\" Episodes)","Apomorphine","DS Agonist","No",null,"No",null,"Phase 3",2,106,"Anticipated","2018-12-19","2020-03-24",{"$nulls":5},"A study of an investigational drug to see how it affects the people with Parkinson's Disease complicated by motor fluctuations (\"OFF\" Episodes) compared to an approved drug used to treat people with Parkinson's Disease complicated by motor fluctuations (\"OFF\" Episodes)","An Open-Label, Randomized, Crossover Trial utilizing a Single-Blinded Rater to evaluate APL-130277 compared to s.c. Apomorphine in Levodopa Responsive Subjects with Parkinson's Disease Complicated by Motor Fluctuations.\n\nPART A consists of an open label, crossover titration phase where eligible subjects will be randomized to 1 of 2 treatment sequences in a 1:1 ratio to Sublingual APL 130277 followed by subcutaneous apomorphine or subcutaneous apomorphine followed by sublingual APL 130277. Subjects will undergo dose titration with the first study treatment (APL 130277 or sc apomorphine) to tolerance and effect, ie, the tolerable dose that turns the subject from the practically defined \"OFF\" state to the full \"ON\" state as determined by both the Investigator and subject. The subject will then be crossed over to the other study treatment (APL 130277 or subcutaneous apomorphine) and similarly titrated to tolerance and effect. These determined doses of APL 130277 and subcutaneous apomorphine will be used during PART B.\n\nPART B consists of an open-label, crossover treatment period where subjects will be randomized to one of the study treatment for 4 weeks, then be crossed over to the other study treatment (APL-130277 or sc apomorphine) for additional 4-weeks of open-label treatment. Subjects return to the clinic for safety and efficacy assessments throughout the treatment period.\n\nThis study is designed to test the superiority of sublingually administered APL-130277 against subcutaneously injected apomorphine (APO-go) for the treatment of \"OFF\" episodes in patients with Parkinson's Disease, as measured by the change from pre-dose to 90 minutes post-dose in MDS UPDRS Part III score in Part B after 4 weeks of dosing in each crossover period.","An Open-Label, Randomized, Crossover Trial Utilizing a Single-Blinded Rater to Evaluate APL-130277 Compared to Subcutaneous Apomorphine in Levodopa Responsive Subjects With Parkinson's Disease Complicated by Motor Fluctuations","CTH-302","Motor OFF Episodes Associated With Parkinson's Disease","Parkinson Disease","Central Nervous System Diseases","Central Nervous System","Experimental|Active Comparator","APL-130277|subcutaneous apomorphine","APL-130277: Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A|subcutaneous apomorphine , Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A","Drug","APL-130277|subcutaneous apomorphine","APL-130277: Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A|subcutaneous apomorphine Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A","Apomorphine Hydrochloride|APO-goÂ®","APL-130277|subcutaneous apomorphine","\n\n 1.  The subject (and caregiver, if applicable) must be fully informed of and understand the objectives, procedures, and possible benefits and risks of the study, and give written informed consent prior to performing any study related activities.\n 2.  Male or female â‰¥ 18 years of age.\n 3.  Clinical diagnosis of Idiopathic PD, consistent with UK Brain Bank Criteria (excluding the \"more than one affected relative\" criterion).\n 4.  Clinically meaningful response to levodopa (L-Dopa), as determined by the Investigator.\n 5.  Subjects at screening must demonstrate an adequate L-Dopa response on the MDS UPDRS Part III in the \"ON\" state compared to the MDS UPDRS Part III in the \"OFF\" state and on the Hoehn and Yahr, as determined during the review by Enrollment Adjudication Committee (EAC), Sponsor, and Medical Monitor.\n 6.  Receiving stable doses of L Dopa/carbidopa and/or L Dopa/benserazide and/or L Dopa/carbidopa/entacapone (immediate or chronic release) administered at least 4 times per day OR Rytaryâ„¢ administered at least 3 times per day for at least 4 weeks before the initial screening Visit (SV1). Adjunctive PD medication regimens are permitted but must be maintained at a stable dose for at least 4 weeks prior to SV1 with the exception of monoamine oxidase B (MAO B) inhibitors, which must be maintained at a stable level for at least 8 weeks prior to SV1.\n 7.  No planned medication change(s) or surgical intervention anticipated during the course of study.\n 8.  Subjects must experience at least one well defined \"OFF\" episode per day and have a total daily \"OFF\" time duration of > 2 hours during the waking day, based on judgment of physician and subject self assessment.\n 9.  Subject must have predictable morning \"OFF\" periods, based on judgment of physician and subject self assessment.\n 10. Subject, and where appropriate caregiver, must be trained in completing the home dosing diaries and able to recognize \"ON\" and \"OFF\" states.\n 11. Stage III or less on the modified Hoehn and Yahr scale in the \"ON\" state.\n 12. Mini-Mental State Examination (MMSE) score > 25.\n 13. Female subject of childbearing potential and male subject with female partner of childbearing potential must agree to either remain abstinent or use adequate and reliable contraception throughout the study and for at least 7 days after the last dose of study drug has been taken. Note: Continued use of adequate and reliable contraception is recommended through 30 days after study completion.\n 14. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study related procedures to complete the study.\n 15. Must be approved as a satisfactory candidate by the Enrollment Adjudication Committee (EAC), Medical Monitor, and Sponsor.\n\n","\n\n 1.  Atypical or secondary parkinsonism.\n 2.  Major focal brain disorders including malignancy or stroke.\n 3.  Prior treatment with any of the following: a neurosurgical procedure for PD; continuous subcutaneous (subcutaneous) apomorphine infusion; subcutaneous (subcutaneous) apomorphine injection; Duodopa/Duopa; or APL-130277.\n 4.  Contraindications to domperidone, subcutaneous apomorphine, or hypersensitivity to apomorphine hydrochloride or any of the ingredients of subcutaneous apomorphine (notably sodium metabisulfite).\n 5.  Female who is pregnant or lactating.\n 6.  Participation in an interventional clinical study and/or receipt of any investigational (ie, unapproved) medication within 30 days prior to SV1.\n 7.  Currently taking selective 5HT3 antagonists (ie, ondansetron, granisetron, dolasetron, palonosetron, alosetron), dopamine antagonists (excluding quetiapine or clozapine) or dopamine depleting agents. Subjects receiving anti depressants must be on a stable daily dose for at least 8 weeks prior to SV1.\n 8.  The subject has a current diagnosis or history of substance abuse (excluding nicotine and caffeine) or alcohol abuse (in the opinion of the investigator) < 6 months prior to SV1.\n 9.  The recreational use of cannabinoids and hallucinogenic are excluded, as well any use of a sublingual formulation of any drug.\n 10. Subject has a history of malignancy within 5 years prior to SV1, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.\n 11. Subject has a clinically significant abnormality on screening evaluation including physical examination, vital signs, electrocardiogram (ECG), or laboratory tests that the Investigator considers to be inappropriate to allow participation in the study.\n 12. Subject has screening laboratory test results of: blood urea nitrogen (BUN) value â‰¥ 1.5 times the upper limit of normal (ULN) for the reference range; serum creatinine > 1.5 times the ULN for the reference range; or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value â‰¥ 2 times the ULN for the reference laboratory.\n 13. Subject has random (non-fasting) screening glucose of â‰¥ 200 mg/dL (11.1 mmol/L) or HbA1c > 7.0%.\n 14. Subjects with type 1 diabetes, or insulin dependent diabetics are excluded. Subjects with type 2 diabetes are eligible for study inclusion if the following conditions are met: * Subject's screening glucose is < 200 mg/dL (11.1 mmol/L). Note: Subjects with random (non fasting) blood glucose at screening â‰¥ 200 mg/dL (11.1 mmol/L) must be retested in a fasted state; and\n      * Subject's hemoglobin A1c (HbA1c) â‰¤ 7.0%; and\n      * If the subject is currently being treated with oral anti-diabetic medication(s), the dose must have been stable for at least 4 weeks prior to SV1. Such medication may be adjusted or discontinued during the study, as clinically indicated.\n     \n     \n 15. The subject's screening ECG results of corrected QT interval using Fridericia's formula (QTcF) â‰¥ 450 msec for male subjects or â‰¥ 470 msec for female subjects. Eligibility will be based on the core laboratory ECG interpretation report.\n 16. Subject has a positive screening laboratory test result for human immunodeficiency virus (HIV).\n 17. Subject has a positive screening laboratory test result for hepatitis B surface antigen or hepatitis C antibodies and has liver function test results at screening above the ULN for the reference laboratory.\n 18. Subject has any other medical disorder that, in the opinion of the Investigator, could interfere with the subject's participation in the study.\n 19. Subject has major psychiatric disorder(s), including but not limited to: bipolar disorder, psychosis (eg, Parkinson's Disease Psychosis), major depressive episode, or any disorder that, in the opinion of the Investigator, would require treatment that could make study participation unsafe or make treatment compliance difficult.\n 20. History of clinically significant impulse control disorder(s).\n 21. History of symptomatic orthostatic hypotension requiring medication.\n 22. History of severe dyskinesia based on a score of 4 on the MDS-UPDRS Part IV.\n 23. Dementia that precludes providing informed consent or would interfere with participation in the study.\n 24. Current/recent suicidal ideation as evidenced by answering \"yes\" to \"Suicidal Ideation\" item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) on the C-SSRS assessment at screening (using the \"screening /Baseline Version\" scale, in the past 12 months) or attempted suicide within the last 5 years.\n 25. Presence of canker or mouth sores in the 30 days prior to SV1, or other clinically significant oral pathology in the opinion of the Investigator. The Investigator should follow-up with an appropriate specialist on any finding, if indicated, before enrolling a subject into the study","MAOB","monoamine oxidase B","Gene","Prostate","Actual","2018-01-05","Actual","Anticipated","2020-03-24","Anticipated","2019-03-01","2018-01-02","2018-01-02","2019-03-25","No","Parkinson's Disease\n\"Off\" Episodes\nmotor fluctuations associated with Parkinson's Disease","Interventional","Treatment","Crossover Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":4},"Yes",{"$nulls":12},"2016-003456-70","EudraCT Number","change from pre-dose to 90 minutes post-dose in MDS UPDRS Part III score after 4 weeks of dosing in each crossover period (assessed by the blinded-rater in-clinic at Visit 3 and Visit 6 of PART B).","Week 4",null,"Durability of effect, defined as an Investigator confirmed full \"ON\" within 30 minutes post dose and at 90 minutes post-dose, after 4 weeks of dosing in each crossover period (assessed by the blinded-rater in-clinic at Visit 3 and Visit 6 of PART B).|Subject preference for treatment regimen as measured by the Subject Preference Visual Analog Scale (VAS) after the subject has completed both APL 130277 and sc apomorphine treatment regimens (assessed in-clinic at Visit 6 of PART B).|Per the Expanded Home Dosing Diary, percent of \"ON\" episodes without troublesome dyskinesia based on the 3 consecutive days prior to Visit 2, Visit 3, Visit 5, and Visit 6.|Subject confirmed durability of effect, defined as subject confirmed full \"ON\" within 30 minutes post-dose and at 90 minutes post-dose, after 4 weeks of dosing in each crossover period (assessed in-clinic at Visit 3 and Visit 6 of PART B).|Patient Global Impression of Change (PGI-C): Subject improvement of \"OFF\" episodes, defined as very much better, much better or a little better after 4 weeks of dosing in each crossover period (assessed in-clinic at Visit 3 and Visit 6 of PART B).","Week 4|with a recorded range of -50 to 50. Negative values indicate preference for SC treatment, and the more negative the value, the stronger is the preference for SC compared to APL treatment. Positive values indicate preference for APL treatment, and the more positive the value, the stronger is the preference for APL compared to SC treatment. A value of 0 indicates no preference of one treatment over the other.","Week 4","clinicaltrialdisclosure@sunovion.com","CNS Medical Director","1-866-503-6351","Innsbruck, Austria, A-6020|Marseille, France, 13385|Beelitz-Heilstatten, Germany, 14547|Cassino, Italy, 03043|Barcelona, Spain, 08036|London, United Kingdom, Se5 9Rs",null,"Austria|France|Germany|Italy|Spain|United Kingdom","Medical University Innsbruck, Neurolgy Dept|Hopital La Timone, Neurologie Et Pathologie Due Mouvement|Klinken Beelitz Gmbh Neurologisches Fachkrankenhaus Fur Bewegungsstorungen/Parkinson|San Raffaele Cassino|Hospital Clinic De Barcelona|King's College Hospital Nhs Foundation Trust",{"$nulls":3},"CNS Medical Director","2019-03-25","2020-05-25T16:35:27.131","2020-05-26T17:10:42.972","NCT03391882"]
["5ecbf3cffeab101b155307ee","NCT03391882","2019-04-01","Sunovion","SEPR","Recruiting","A Study of an Investigational Drug to See How it Affects the People With Parkinson's Disease Complicated by Motor Fluctuations (\"OFF\" Episodes) Compared to an Approved Drug Used to Treat People With Parkinson's Disease Complicated by Motor Fluctuations (\"OFF\" Episodes)","Apomorphine","DS Agonist","No",null,"No",null,"Phase 3",2,106,"Anticipated","2018-12-19","2020-03-24",{"$nulls":5},"A study of an investigational drug to see how it affects the people with Parkinson's Disease complicated by motor fluctuations (\"OFF\" Episodes) compared to an approved drug used to treat people with Parkinson's Disease complicated by motor fluctuations (\"OFF\" Episodes)","An Open-Label, Randomized, Crossover Trial utilizing a Single-Blinded Rater to evaluate APL-130277 compared to s.c. Apomorphine in Levodopa Responsive Subjects with Parkinson's Disease Complicated by Motor Fluctuations.\n\nPART A consists of an open label, crossover titration phase where eligible subjects will be randomized to 1 of 2 treatment sequences in a 1:1 ratio to Sublingual APL 130277 followed by subcutaneous apomorphine or subcutaneous apomorphine followed by sublingual APL 130277. Subjects will undergo dose titration with the first study treatment (APL 130277 or sc apomorphine) to tolerance and effect, ie, the tolerable dose that turns the subject from the practically defined \"OFF\" state to the full \"ON\" state as determined by both the Investigator and subject. The subject will then be crossed over to the other study treatment (APL 130277 or subcutaneous apomorphine) and similarly titrated to tolerance and effect. These determined doses of APL 130277 and subcutaneous apomorphine will be used during PART B.\n\nPART B consists of an open-label, crossover treatment period where subjects will be randomized to one of the study treatment for 4 weeks, then be crossed over to the other study treatment (APL-130277 or sc apomorphine) for additional 4-weeks of open-label treatment. Subjects return to the clinic for safety and efficacy assessments throughout the treatment period.\n\nThis study is designed to test the superiority of sublingually administered APL-130277 against subcutaneously injected apomorphine (APO-go) for the treatment of \"OFF\" episodes in patients with Parkinson's Disease, as measured by the change from pre-dose to 90 minutes post-dose in MDS UPDRS Part III score in Part B after 4 weeks of dosing in each crossover period.","An Open-Label, Randomized, Crossover Trial Utilizing a Single-Blinded Rater to Evaluate APL-130277 Compared to Subcutaneous Apomorphine in Levodopa Responsive Subjects With Parkinson's Disease Complicated by Motor Fluctuations","CTH-302","Motor OFF Episodes Associated With Parkinson's Disease","Parkinson Disease","Central Nervous System Diseases","Central Nervous System","Experimental|Active Comparator","APL-130277|subcutaneous apomorphine","APL-130277: Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A|subcutaneous apomorphine , Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A","Drug","APL-130277|subcutaneous apomorphine","APL-130277: Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A|subcutaneous apomorphine Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A","Apomorphine Hydrochloride|APO-goÂ®","APL-130277|subcutaneous apomorphine","\n\n 1.  The subject (and caregiver, if applicable) must be fully informed of and understand the objectives, procedures, and possible benefits and risks of the study, and give written informed consent prior to performing any study related activities.\n 2.  Male or female â‰¥ 18 years of age.\n 3.  Clinical diagnosis of Idiopathic PD, consistent with UK Brain Bank Criteria (excluding the \"more than one affected relative\" criterion).\n 4.  Clinically meaningful response to levodopa (L-Dopa), as determined by the Investigator.\n 5.  Subjects at screening must demonstrate an adequate L-Dopa response on the MDS UPDRS Part III in the \"ON\" state compared to the MDS UPDRS Part III in the \"OFF\" state and on the Hoehn and Yahr, as determined during the review by Enrollment Adjudication Committee (EAC), Sponsor, and Medical Monitor.\n 6.  Receiving stable doses of L Dopa/carbidopa and/or L Dopa/benserazide and/or L Dopa/carbidopa/entacapone (immediate or chronic release) administered at least 4 times per day OR Rytaryâ„¢ administered at least 3 times per day for at least 4 weeks before the initial screening Visit (SV1). Adjunctive PD medication regimens are permitted but must be maintained at a stable dose for at least 4 weeks prior to SV1 with the exception of monoamine oxidase B (MAO B) inhibitors, which must be maintained at a stable level for at least 8 weeks prior to SV1.\n 7.  No planned medication change(s) or surgical intervention anticipated during the course of study.\n 8.  Subjects must experience at least one well defined \"OFF\" episode per day and have a total daily \"OFF\" time duration of > 2 hours during the waking day, based on judgment of physician and subject self assessment.\n 9.  Subject must have predictable morning \"OFF\" periods, based on judgment of physician and subject self assessment.\n 10. Subject, and where appropriate caregiver, must be trained in completing the home dosing diaries and able to recognize \"ON\" and \"OFF\" states.\n 11. Stage III or less on the modified Hoehn and Yahr scale in the \"ON\" state.\n 12. Mini-Mental State Examination (MMSE) score > 25.\n 13. Female subject of childbearing potential and male subject with female partner of childbearing potential must agree to either remain abstinent or use adequate and reliable contraception throughout the study and for at least 7 days after the last dose of study drug has been taken. Note: Continued use of adequate and reliable contraception is recommended through 30 days after study completion.\n 14. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study related procedures to complete the study.\n 15. Must be approved as a satisfactory candidate by the Enrollment Adjudication Committee (EAC), Medical Monitor, and Sponsor.\n\n","\n\n 1.  Atypical or secondary parkinsonism.\n 2.  Major focal brain disorders including malignancy or stroke.\n 3.  Prior treatment with any of the following: a neurosurgical procedure for PD; continuous subcutaneous (subcutaneous) apomorphine infusion; subcutaneous (subcutaneous) apomorphine injection; Duodopa/Duopa; or APL-130277.\n 4.  Contraindications to domperidone, subcutaneous apomorphine, or hypersensitivity to apomorphine hydrochloride or any of the ingredients of subcutaneous apomorphine (notably sodium metabisulfite).\n 5.  Female who is pregnant or lactating.\n 6.  Participation in an interventional clinical study and/or receipt of any investigational (ie, unapproved) medication within 30 days prior to SV1.\n 7.  Currently taking selective 5HT3 antagonists (ie, ondansetron, granisetron, dolasetron, palonosetron, alosetron), dopamine antagonists (excluding quetiapine or clozapine) or dopamine depleting agents. Subjects receiving anti depressants must be on a stable daily dose for at least 8 weeks prior to SV1.\n 8.  The subject has a current diagnosis or history of substance abuse (excluding nicotine and caffeine) or alcohol abuse (in the opinion of the investigator) < 6 months prior to SV1.\n 9.  The recreational use of cannabinoids and hallucinogenic are excluded, as well any use of a sublingual formulation of any drug.\n 10. Subject has a history of malignancy within 5 years prior to SV1, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.\n 11. Subject has a clinically significant abnormality on screening evaluation including physical examination, vital signs, electrocardiogram (ECG), or laboratory tests that the Investigator considers to be inappropriate to allow participation in the study.\n 12. Subject has screening laboratory test results of: blood urea nitrogen (BUN) value â‰¥ 1.5 times the upper limit of normal (ULN) for the reference range; serum creatinine > 1.5 times the ULN for the reference range; or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value â‰¥ 2 times the ULN for the reference laboratory.\n 13. Subject has random (non-fasting) screening glucose of â‰¥ 200 mg/dL (11.1 mmol/L) or HbA1c > 7.0%.\n 14. Subjects with type 1 diabetes, or insulin dependent diabetics are excluded. Subjects with type 2 diabetes are eligible for study inclusion if the following conditions are met: * Subject's screening glucose is < 200 mg/dL (11.1 mmol/L). Note: Subjects with random (non fasting) blood glucose at screening â‰¥ 200 mg/dL (11.1 mmol/L) must be retested in a fasted state; and\n      * Subject's hemoglobin A1c (HbA1c) â‰¤ 7.0%; and\n      * If the subject is currently being treated with oral anti-diabetic medication(s), the dose must have been stable for at least 4 weeks prior to SV1. Such medication may be adjusted or discontinued during the study, as clinically indicated.\n     \n     \n 15. The subject's screening ECG results of corrected QT interval using Fridericia's formula (QTcF) â‰¥ 450 msec for male subjects or â‰¥ 470 msec for female subjects. Eligibility will be based on the core laboratory ECG interpretation report.\n 16. Subject has a positive screening laboratory test result for human immunodeficiency virus (HIV).\n 17. Subject has a positive screening laboratory test result for hepatitis B surface antigen or hepatitis C antibodies and has liver function test results at screening above the ULN for the reference laboratory.\n 18. Subject has any other medical disorder that, in the opinion of the Investigator, could interfere with the subject's participation in the study.\n 19. Subject has major psychiatric disorder(s), including but not limited to: bipolar disorder, psychosis (eg, Parkinson's Disease Psychosis), major depressive episode, or any disorder that, in the opinion of the Investigator, would require treatment that could make study participation unsafe or make treatment compliance difficult.\n 20. History of clinically significant impulse control disorder(s).\n 21. History of symptomatic orthostatic hypotension requiring medication.\n 22. History of severe dyskinesia based on a score of 4 on the MDS-UPDRS Part IV.\n 23. Dementia that precludes providing informed consent or would interfere with participation in the study.\n 24. Current/recent suicidal ideation as evidenced by answering \"yes\" to \"Suicidal Ideation\" item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) on the C-SSRS assessment at screening (using the \"screening /Baseline Version\" scale, in the past 12 months) or attempted suicide within the last 5 years.\n 25. Presence of canker or mouth sores in the 30 days prior to SV1, or other clinically significant oral pathology in the opinion of the Investigator. The Investigator should follow-up with an appropriate specialist on any finding, if indicated, before enrolling a subject into the study","MAOB","monoamine oxidase B","Gene","Prostate","Actual","2018-01-05","Actual","Anticipated","2020-03-24","Anticipated","2019-03-01","2018-01-02","2018-01-02","2019-03-29","No","Parkinson's Disease\n\"Off\" Episodes\nmotor fluctuations associated with Parkinson's Disease","Interventional","Treatment","Crossover Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":4},"Yes",{"$nulls":12},"2016-003456-70","EudraCT Number","change from pre-dose to 90 minutes post-dose in MDS UPDRS Part III score after 4 weeks of dosing in each crossover period (assessed by the blinded-rater in-clinic at Visit 3 and Visit 6 of PART B).","Week 4",null,"Durability of effect, defined as an Investigator confirmed full \"ON\" within 30 minutes post dose and at 90 minutes post-dose, after 4 weeks of dosing in each crossover period (assessed by the blinded-rater in-clinic at Visit 3 and Visit 6 of PART B).|Subject preference for treatment regimen as measured by the Subject Preference Visual Analog Scale (VAS) after the subject has completed both APL 130277 and sc apomorphine treatment regimens (assessed in-clinic at Visit 6 of PART B).|Per the Expanded Home Dosing Diary, percent of \"ON\" episodes without troublesome dyskinesia based on the 3 consecutive days prior to Visit 2, Visit 3, Visit 5, and Visit 6.|Subject confirmed durability of effect, defined as subject confirmed full \"ON\" within 30 minutes post-dose and at 90 minutes post-dose, after 4 weeks of dosing in each crossover period (assessed in-clinic at Visit 3 and Visit 6 of PART B).|Patient Global Impression of Change (PGI-C): Subject improvement of \"OFF\" episodes, defined as very much better, much better or a little better after 4 weeks of dosing in each crossover period (assessed in-clinic at Visit 3 and Visit 6 of PART B).","Week 4|with a recorded range of -50 to 50. Negative values indicate preference for SC treatment, and the more negative the value, the stronger is the preference for SC compared to APL treatment. Positive values indicate preference for APL treatment, and the more positive the value, the stronger is the preference for APL compared to SC treatment. A value of 0 indicates no preference of one treatment over the other.","Week 4","clinicaltrialdisclosure@sunovion.com","CNS Medical Director","1-866-503-6351","Innsbruck, Austria, A-6020|Marseille, France, 13385|Beelitz-Heilstatten, Germany, 14547|Cassino, Italy, 03043|Barcelona, Spain, 08036|London, United Kingdom, Se5 9Rs",null,"Austria|France|Germany|Italy|Spain|United Kingdom","Medical University Innsbruck, Neurolgy Dept|Hopital La Timone, Neurologie Et Pathologie Due Mouvement|Klinken Beelitz Gmbh Neurologisches Fachkrankenhaus Fur Bewegungsstorungen/Parkinson|San Raffaele Cassino|Hospital Clinic De Barcelona|King's College Hospital Nhs Foundation Trust",{"$nulls":3},"CNS Medical Director","2019-03-29","2020-05-25T16:35:27.274","2020-05-26T17:10:42.972","NCT03391882"]
["5ecbf3cffe30261b1a0481c0","NCT03391882","2019-05-15","Sunovion","SEPR","Recruiting","A Study of an Investigational Drug to See How it Affects the People With Parkinson's Disease Complicated by Motor Fluctuations (\"OFF\" Episodes) Compared to an Approved Drug Used to Treat People With Parkinson's Disease Complicated by Motor Fluctuations (\"OFF\" Episodes)","Apomorphine","DS Agonist","No",null,"No",null,"Phase 3",2,106,"Anticipated","2018-12-19","2020-03-24",{"$nulls":5},"A study of an investigational drug to see how it affects the people with Parkinson's Disease complicated by motor fluctuations (\"OFF\" Episodes) compared to an approved drug used to treat people with Parkinson's Disease complicated by motor fluctuations (\"OFF\" Episodes)","An Open-Label, Randomized, Crossover Trial utilizing a Single-Blinded Rater to evaluate APL-130277 compared to s.c. Apomorphine in Levodopa Responsive Subjects with Parkinson's Disease Complicated by Motor Fluctuations.\n\nPART A consists of an open label, crossover titration phase where eligible subjects will be randomized to 1 of 2 treatment sequences in a 1:1 ratio to Sublingual APL 130277 followed by subcutaneous apomorphine or subcutaneous apomorphine followed by sublingual APL 130277. Subjects will undergo dose titration with the first study treatment (APL 130277 or sc apomorphine) to tolerance and effect, ie, the tolerable dose that turns the subject from the practically defined \"OFF\" state to the full \"ON\" state as determined by both the Investigator and subject. The subject will then be crossed over to the other study treatment (APL 130277 or subcutaneous apomorphine) and similarly titrated to tolerance and effect. These determined doses of APL 130277 and subcutaneous apomorphine will be used during PART B.\n\nPART B consists of an open-label, crossover treatment period where subjects will be randomized to one of the study treatment for 4 weeks, then be crossed over to the other study treatment (APL-130277 or sc apomorphine) for additional 4-weeks of open-label treatment. Subjects return to the clinic for safety and efficacy assessments throughout the treatment period.\n\nThis study is designed to test the superiority of sublingually administered APL-130277 against subcutaneously injected apomorphine (APO-go) for the treatment of \"OFF\" episodes in patients with Parkinson's Disease, as measured by the change from pre-dose to 90 minutes post-dose in MDS UPDRS Part III score in Part B after 4 weeks of dosing in each crossover period.","An Open-Label, Randomized, Crossover Trial Utilizing a Single-Blinded Rater to Evaluate APL-130277 Compared to Subcutaneous Apomorphine in Levodopa Responsive Subjects With Parkinson's Disease Complicated by Motor Fluctuations","CTH-302","Motor OFF Episodes Associated With Parkinson's Disease","Parkinson Disease","Central Nervous System Diseases","Central Nervous System","Experimental|Active Comparator","APL-130277|subcutaneous apomorphine","APL-130277: Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A|subcutaneous apomorphine , Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A","Drug","APL-130277|subcutaneous apomorphine","APL-130277: Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A|subcutaneous apomorphine Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A","Apomorphine Hydrochloride|APO-goÂ®","APL-130277|subcutaneous apomorphine","\n\n 1.  The subject (and caregiver, if applicable) must be fully informed of and understand the objectives, procedures, and possible benefits and risks of the study, and give written informed consent prior to performing any study related activities.\n 2.  Male or female â‰¥ 18 years of age.\n 3.  Clinical diagnosis of Idiopathic PD, consistent with UK Brain Bank Criteria (excluding the \"more than one affected relative\" criterion).\n 4.  Clinically meaningful response to levodopa (L-Dopa), as determined by the Investigator.\n 5.  Subjects at screening must demonstrate an adequate L-Dopa response on the MDS UPDRS Part III in the \"ON\" state compared to the MDS UPDRS Part III in the \"OFF\" state and on the Hoehn and Yahr, as determined during the review by Enrollment Adjudication Committee (EAC), Sponsor, and Medical Monitor.\n 6.  Receiving stable doses of L Dopa/carbidopa and/or L Dopa/benserazide and/or L Dopa/carbidopa/entacapone (immediate or chronic release) administered at least 4 times per day OR Rytaryâ„¢ administered at least 3 times per day for at least 4 weeks before the initial screening Visit (SV1). Adjunctive PD medication regimens are permitted but must be maintained at a stable dose for at least 4 weeks prior to SV1 with the exception of monoamine oxidase B (MAO B) inhibitors, which must be maintained at a stable level for at least 8 weeks prior to SV1.\n 7.  No planned medication change(s) or surgical intervention anticipated during the course of study.\n 8.  Subjects must experience at least one well defined \"OFF\" episode per day and have a total daily \"OFF\" time duration of > 2 hours during the waking day, based on judgment of physician and subject self assessment.\n 9.  Subject must have predictable morning \"OFF\" periods, based on judgment of physician and subject self assessment.\n 10. Subject, and where appropriate caregiver, must be trained in completing the home dosing diaries and able to recognize \"ON\" and \"OFF\" states.\n 11. Stage III or less on the modified Hoehn and Yahr scale in the \"ON\" state.\n 12. Mini-Mental State Examination (MMSE) score > 25.\n 13. Female subject of childbearing potential and male subject with female partner of childbearing potential must agree to either remain abstinent or use adequate and reliable contraception throughout the study and for at least 7 days after the last dose of study drug has been taken. Note: Continued use of adequate and reliable contraception is recommended through 30 days after study completion.\n 14. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study related procedures to complete the study.\n 15. Must be approved as a satisfactory candidate by the Enrollment Adjudication Committee (EAC), Medical Monitor, and Sponsor.\n\n","\n\n 1.  Atypical or secondary parkinsonism.\n 2.  Major focal brain disorders including malignancy or stroke.\n 3.  Prior treatment with any of the following: a neurosurgical procedure for PD; continuous subcutaneous (subcutaneous) apomorphine infusion; subcutaneous (subcutaneous) apomorphine injection; Duodopa/Duopa; or APL-130277.\n 4.  Contraindications to domperidone, subcutaneous apomorphine, or hypersensitivity to apomorphine hydrochloride or any of the ingredients of subcutaneous apomorphine (notably sodium metabisulfite).\n 5.  Female who is pregnant or lactating.\n 6.  Participation in an interventional clinical study and/or receipt of any investigational (ie, unapproved) medication within 30 days prior to SV1.\n 7.  Currently taking selective 5HT3 antagonists (ie, ondansetron, granisetron, dolasetron, palonosetron, alosetron), dopamine antagonists (excluding quetiapine or clozapine) or dopamine depleting agents. Subjects receiving anti depressants must be on a stable daily dose for at least 8 weeks prior to SV1.\n 8.  The subject has a current diagnosis or history of substance abuse (excluding nicotine and caffeine) or alcohol abuse (in the opinion of the investigator) < 6 months prior to SV1.\n 9.  The recreational use of cannabinoids and hallucinogenic are excluded, as well any use of a sublingual formulation of any drug.\n 10. Subject has a history of malignancy within 5 years prior to SV1, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.\n 11. Subject has a clinically significant abnormality on screening evaluation including physical examination, vital signs, electrocardiogram (ECG), or laboratory tests that the Investigator considers to be inappropriate to allow participation in the study.\n 12. Subject has screening laboratory test results of: blood urea nitrogen (BUN) value â‰¥ 1.5 times the upper limit of normal (ULN) for the reference range; serum creatinine > 1.5 times the ULN for the reference range; or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value â‰¥ 2 times the ULN for the reference laboratory.\n 13. Subject has random (non-fasting) screening glucose of â‰¥ 200 mg/dL (11.1 mmol/L) or HbA1c > 7.0%.\n 14. Subjects with type 1 diabetes, or insulin dependent diabetics are excluded. Subjects with type 2 diabetes are eligible for study inclusion if the following conditions are met: * Subject's screening glucose is < 200 mg/dL (11.1 mmol/L). Note: Subjects with random (non fasting) blood glucose at screening â‰¥ 200 mg/dL (11.1 mmol/L) must be retested in a fasted state; and\n      * Subject's hemoglobin A1c (HbA1c) â‰¤ 7.0%; and\n      * If the subject is currently being treated with oral anti-diabetic medication(s), the dose must have been stable for at least 4 weeks prior to SV1. Such medication may be adjusted or discontinued during the study, as clinically indicated.\n     \n     \n 15. The subject's screening ECG results of corrected QT interval using Fridericia's formula (QTcF) â‰¥ 450 msec for male subjects or â‰¥ 470 msec for female subjects. Eligibility will be based on the core laboratory ECG interpretation report.\n 16. Subject has a positive screening laboratory test result for human immunodeficiency virus (HIV).\n 17. Subject has a positive screening laboratory test result for hepatitis B surface antigen or hepatitis C antibodies and has liver function test results at screening above the ULN for the reference laboratory.\n 18. Subject has any other medical disorder that, in the opinion of the Investigator, could interfere with the subject's participation in the study.\n 19. Subject has major psychiatric disorder(s), including but not limited to: bipolar disorder, psychosis (eg, Parkinson's Disease Psychosis), major depressive episode, or any disorder that, in the opinion of the Investigator, would require treatment that could make study participation unsafe or make treatment compliance difficult.\n 20. History of clinically significant impulse control disorder(s).\n 21. History of symptomatic orthostatic hypotension requiring medication.\n 22. History of severe dyskinesia based on a score of 4 on the MDS-UPDRS Part IV.\n 23. Dementia that precludes providing informed consent or would interfere with participation in the study.\n 24. Current/recent suicidal ideation as evidenced by answering \"yes\" to \"Suicidal Ideation\" item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) on the C-SSRS assessment at screening (using the \"screening /Baseline Version\" scale, in the past 12 months) or attempted suicide within the last 5 years.\n 25. Presence of canker or mouth sores in the 30 days prior to SV1, or other clinically significant oral pathology in the opinion of the Investigator. The Investigator should follow-up with an appropriate specialist on any finding, if indicated, before enrolling a subject into the study","MAOB","monoamine oxidase B","Gene","Prostate","Actual","2018-01-05","Actual","Anticipated","2020-03-24","Anticipated","2019-05-01","2018-01-02","2018-01-02","2019-05-14","No","Parkinson's Disease\n\"Off\" Episodes\nmotor fluctuations associated with Parkinson's Disease","Interventional","Treatment","Crossover Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":4},"Yes",{"$nulls":12},"2016-003456-70","EudraCT Number","change from pre-dose to 90 minutes post-dose in MDS UPDRS Part III score after 4 weeks of dosing in each crossover period (assessed by the blinded-rater in-clinic at Visit 3 and Visit 6 of PART B).","Week 4",null,"Durability of effect, defined as an Investigator confirmed full \"ON\" within 30 minutes post dose and at 90 minutes post-dose, after 4 weeks of dosing in each crossover period (assessed by the blinded-rater in-clinic at Visit 3 and Visit 6 of PART B).|Subject preference for treatment regimen as measured by the Subject Preference Visual Analog Scale (VAS) after the subject has completed both APL 130277 and sc apomorphine treatment regimens (assessed in-clinic at Visit 6 of PART B).|Per the Expanded Home Dosing Diary, percent of \"ON\" episodes without troublesome dyskinesia based on the 3 consecutive days prior to Visit 2, Visit 3, Visit 5, and Visit 6.|Subject confirmed durability of effect, defined as subject confirmed full \"ON\" within 30 minutes post-dose and at 90 minutes post-dose, after 4 weeks of dosing in each crossover period (assessed in-clinic at Visit 3 and Visit 6 of PART B).|Patient Global Impression of Change (PGI-C): Subject improvement of \"OFF\" episodes, defined as very much better, much better or a little better after 4 weeks of dosing in each crossover period (assessed in-clinic at Visit 3 and Visit 6 of PART B).","Week 4|with a recorded range of -50 to 50. Negative values indicate preference for SC treatment, and the more negative the value, the stronger is the preference for SC compared to APL treatment. Positive values indicate preference for APL treatment, and the more positive the value, the stronger is the preference for APL compared to SC treatment. A value of 0 indicates no preference of one treatment over the other.","Week 4","clinicaltrialdisclosure@sunovion.com","CNS Medical Director","1-866-503-6351","Innsbruck, Austria, A-6020|Marseille, France, 13385|Beelitz-Heilstatten, Germany, 14547|Cassino, Italy, 03043|Barcelona, Spain, 08036|London, United Kingdom, Se5 9Rs",null,"Austria|France|Germany|Italy|Spain|United Kingdom","Medical University Innsbruck, Neurolgy Dept|Hopital La Timone, Neurologie Et Pathologie Due Mouvement|Klinken Beelitz Gmbh Neurologisches Fachkrankenhaus Fur Bewegungsstorungen/Parkinson|San Raffaele Cassino|Hospital Clinic De Barcelona|King's College Hospital Nhs Foundation Trust",{"$nulls":3},"CNS Medical Director","2019-05-14","2020-05-25T16:35:27.765","2020-05-26T17:10:42.972","NCT03391882"]
["5ecbf3cf11702c1b1b9169d2","NCT03391882","2019-06-06","Sunovion","SEPR","Recruiting","A Study of an Investigational Drug to See How it Affects the People With Parkinson's Disease Complicated by Motor Fluctuations (\"OFF\" Episodes) Compared to an Approved Drug Used to Treat People With Parkinson's Disease Complicated by Motor Fluctuations (\"OFF\" Episodes)","Apomorphine","DS Agonist","No",null,"No",null,"Phase 3",2,106,"Anticipated","2018-12-19","2020-03-24",{"$nulls":5},"A study of an investigational drug to see how it affects the people with Parkinson's Disease complicated by motor fluctuations (\"OFF\" Episodes) compared to an approved drug used to treat people with Parkinson's Disease complicated by motor fluctuations (\"OFF\" Episodes)","An Open-Label, Randomized, Crossover Trial utilizing a Single-Blinded Rater to evaluate APL-130277 compared to s.c. Apomorphine in Levodopa Responsive Subjects with Parkinson's Disease Complicated by Motor Fluctuations.\n\nPART A consists of an open label, crossover titration phase where eligible subjects will be randomized to 1 of 2 treatment sequences in a 1:1 ratio to Sublingual APL 130277 followed by subcutaneous apomorphine or subcutaneous apomorphine followed by sublingual APL 130277. Subjects will undergo dose titration with the first study treatment (APL 130277 or sc apomorphine) to tolerance and effect, ie, the tolerable dose that turns the subject from the practically defined \"OFF\" state to the full \"ON\" state as determined by both the Investigator and subject. The subject will then be crossed over to the other study treatment (APL 130277 or subcutaneous apomorphine) and similarly titrated to tolerance and effect. These determined doses of APL 130277 and subcutaneous apomorphine will be used during PART B.\n\nPART B consists of an open-label, crossover treatment period where subjects will be randomized to one of the study treatment for 4 weeks, then be crossed over to the other study treatment (APL-130277 or sc apomorphine) for additional 4-weeks of open-label treatment. Subjects return to the clinic for safety and efficacy assessments throughout the treatment period.\n\nThis study is designed to test the superiority of sublingually administered APL-130277 against subcutaneously injected apomorphine (APO-go) for the treatment of \"OFF\" episodes in patients with Parkinson's Disease, as measured by the change from pre-dose to 90 minutes post-dose in MDS UPDRS Part III score in Part B after 4 weeks of dosing in each crossover period.","An Open-Label, Randomized, Crossover Trial Utilizing a Single-Blinded Rater to Evaluate APL-130277 Compared to Subcutaneous Apomorphine in Levodopa Responsive Subjects With Parkinson's Disease Complicated by Motor Fluctuations","CTH-302","Motor OFF Episodes Associated With Parkinson's Disease","Parkinson Disease","Central Nervous System Diseases","Central Nervous System","Experimental|Active Comparator","APL-130277|subcutaneous apomorphine","APL-130277: Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A|subcutaneous apomorphine , Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A","Drug","APL-130277|subcutaneous apomorphine","APL-130277: Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A|subcutaneous apomorphine Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A","Apomorphine Hydrochloride|APO-goÂ®","APL-130277|subcutaneous apomorphine","\n\n 1.  The subject (and caregiver, if applicable) must be fully informed of and understand the objectives, procedures, and possible benefits and risks of the study, and give written informed consent prior to performing any study related activities.\n 2.  Male or female â‰¥ 18 years of age.\n 3.  Clinical diagnosis of Idiopathic PD, consistent with UK Brain Bank Criteria (excluding the \"more than one affected relative\" criterion).\n 4.  Clinically meaningful response to levodopa (L-Dopa), as determined by the Investigator.\n 5.  Subjects at screening must demonstrate an adequate L-Dopa response on the MDS UPDRS Part III in the \"ON\" state compared to the MDS UPDRS Part III in the \"OFF\" state and on the Hoehn and Yahr, as determined during the review by Enrollment Adjudication Committee (EAC), Sponsor, and Medical Monitor.\n 6.  Receiving stable doses of L Dopa/carbidopa and/or L Dopa/benserazide and/or L Dopa/carbidopa/entacapone (immediate or chronic release) administered at least 4 times per day OR Rytaryâ„¢ administered at least 3 times per day for at least 4 weeks before the initial screening Visit (SV1). Adjunctive PD medication regimens are permitted but must be maintained at a stable dose for at least 4 weeks prior to SV1 with the exception of monoamine oxidase B (MAO B) inhibitors, which must be maintained at a stable level for at least 8 weeks prior to SV1.\n 7.  No planned medication change(s) or surgical intervention anticipated during the course of study.\n 8.  Subjects must experience at least one well defined \"OFF\" episode per day and have a total daily \"OFF\" time duration of > 2 hours during the waking day, based on judgment of physician and subject self assessment.\n 9.  Subject must have predictable morning \"OFF\" periods, based on judgment of physician and subject self assessment.\n 10. Subject, and where appropriate caregiver, must be trained in completing the home dosing diaries and able to recognize \"ON\" and \"OFF\" states.\n 11. Stage III or less on the modified Hoehn and Yahr scale in the \"ON\" state.\n 12. Mini-Mental State Examination (MMSE) score > 25.\n 13. Female subject of childbearing potential and male subject with female partner of childbearing potential must agree to either remain abstinent or use adequate and reliable contraception throughout the study and for at least 7 days after the last dose of study drug has been taken. Note: Continued use of adequate and reliable contraception is recommended through 30 days after study completion.\n 14. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study related procedures to complete the study.\n 15. Must be approved as a satisfactory candidate by the Enrollment Adjudication Committee (EAC), Medical Monitor, and Sponsor.\n\n","\n\n 1.  Atypical or secondary parkinsonism.\n 2.  Major focal brain disorders including malignancy or stroke.\n 3.  Prior treatment with any of the following: a neurosurgical procedure for PD; continuous subcutaneous (subcutaneous) apomorphine infusion; subcutaneous (subcutaneous) apomorphine injection; Duodopa/Duopa; or APL-130277.\n 4.  Contraindications to domperidone, subcutaneous apomorphine, or hypersensitivity to apomorphine hydrochloride or any of the ingredients of subcutaneous apomorphine (notably sodium metabisulfite).\n 5.  Female who is pregnant or lactating.\n 6.  Participation in an interventional clinical study and/or receipt of any investigational (ie, unapproved) medication within 30 days prior to SV1.\n 7.  Currently taking selective 5HT3 antagonists (ie, ondansetron, granisetron, dolasetron, palonosetron, alosetron), dopamine antagonists (excluding quetiapine or clozapine) or dopamine depleting agents. Subjects receiving anti depressants must be on a stable daily dose for at least 8 weeks prior to SV1.\n 8.  The subject has a current diagnosis or history of substance abuse (excluding nicotine and caffeine) or alcohol abuse (in the opinion of the investigator) < 6 months prior to SV1.\n 9.  The recreational use of cannabinoids and hallucinogenic are excluded, as well any use of a sublingual formulation of any drug.\n 10. Subject has a history of malignancy within 5 years prior to SV1, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.\n 11. Subject has a clinically significant abnormality on screening evaluation including physical examination, vital signs, electrocardiogram (ECG), or laboratory tests that the Investigator considers to be inappropriate to allow participation in the study.\n 12. Subject has screening laboratory test results of: blood urea nitrogen (BUN) value â‰¥ 1.5 times the upper limit of normal (ULN) for the reference range; serum creatinine > 1.5 times the ULN for the reference range; or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value â‰¥ 2 times the ULN for the reference laboratory.\n 13. Subject has random (non-fasting) screening glucose of â‰¥ 200 mg/dL (11.1 mmol/L) or HbA1c > 7.0%.\n 14. Subjects with type 1 diabetes, or insulin dependent diabetics are excluded. Subjects with type 2 diabetes are eligible for study inclusion if the following conditions are met: * Subject's screening glucose is < 200 mg/dL (11.1 mmol/L). Note: Subjects with random (non fasting) blood glucose at screening â‰¥ 200 mg/dL (11.1 mmol/L) must be retested in a fasted state; and\n      * Subject's hemoglobin A1c (HbA1c) â‰¤ 7.0%; and\n      * If the subject is currently being treated with oral anti-diabetic medication(s), the dose must have been stable for at least 4 weeks prior to SV1. Such medication may be adjusted or discontinued during the study, as clinically indicated.\n     \n     \n 15. The subject's screening ECG results of corrected QT interval using Fridericia's formula (QTcF) â‰¥ 450 msec for male subjects or â‰¥ 470 msec for female subjects. Eligibility will be based on the core laboratory ECG interpretation report.\n 16. Subject has a positive screening laboratory test result for human immunodeficiency virus (HIV).\n 17. Subject has a positive screening laboratory test result for hepatitis B surface antigen or hepatitis C antibodies and has liver function test results at screening above the ULN for the reference laboratory.\n 18. Subject has any other medical disorder that, in the opinion of the Investigator, could interfere with the subject's participation in the study.\n 19. Subject has major psychiatric disorder(s), including but not limited to: bipolar disorder, psychosis (eg, Parkinson's Disease Psychosis), major depressive episode, or any disorder that, in the opinion of the Investigator, would require treatment that could make study participation unsafe or make treatment compliance difficult.\n 20. History of clinically significant impulse control disorder(s).\n 21. History of symptomatic orthostatic hypotension requiring medication.\n 22. History of severe dyskinesia based on a score of 4 on the MDS-UPDRS Part IV.\n 23. Dementia that precludes providing informed consent or would interfere with participation in the study.\n 24. Current/recent suicidal ideation as evidenced by answering \"yes\" to \"Suicidal Ideation\" item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) on the C-SSRS assessment at screening (using the \"screening /Baseline Version\" scale, in the past 12 months) or attempted suicide within the last 5 years.\n 25. Presence of canker or mouth sores in the 30 days prior to SV1, or other clinically significant oral pathology in the opinion of the Investigator. The Investigator should follow-up with an appropriate specialist on any finding, if indicated, before enrolling a subject into the study","MAOB","monoamine oxidase B","Gene","Prostate","Actual","2018-01-05","Actual","Anticipated","2020-03-24","Anticipated","2019-06-01","2018-01-02","2018-01-02","2019-06-05","No","Parkinson's Disease\n\"Off\" Episodes\nmotor fluctuations associated with Parkinson's Disease","Interventional","Treatment","Crossover Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":4},"Yes",{"$nulls":12},"2016-003456-70","EudraCT Number","change from pre-dose to 90 minutes post-dose in MDS UPDRS Part III score after 4 weeks of dosing in each crossover period (assessed by the blinded-rater in-clinic at Visit 3 and Visit 6 of PART B).","Week 4",null,"Durability of effect, defined as an Investigator confirmed full \"ON\" within 30 minutes post dose and at 90 minutes post-dose, after 4 weeks of dosing in each crossover period (assessed by the blinded-rater in-clinic at Visit 3 and Visit 6 of PART B).|Subject preference for treatment regimen as measured by the Subject Preference Visual Analog Scale (VAS) after the subject has completed both APL 130277 and sc apomorphine treatment regimens (assessed in-clinic at Visit 6 of PART B).|Per the Expanded Home Dosing Diary, percent of \"ON\" episodes without troublesome dyskinesia based on the 3 consecutive days prior to Visit 2, Visit 3, Visit 5, and Visit 6.|Subject confirmed durability of effect, defined as subject confirmed full \"ON\" within 30 minutes post-dose and at 90 minutes post-dose, after 4 weeks of dosing in each crossover period (assessed in-clinic at Visit 3 and Visit 6 of PART B).|Patient Global Impression of Change (PGI-C): Subject improvement of \"OFF\" episodes, defined as very much better, much better or a little better after 4 weeks of dosing in each crossover period (assessed in-clinic at Visit 3 and Visit 6 of PART B).","Week 4|with a recorded range of -50 to 50. Negative values indicate preference for SC treatment, and the more negative the value, the stronger is the preference for SC compared to APL treatment. Positive values indicate preference for APL treatment, and the more positive the value, the stronger is the preference for APL compared to SC treatment. A value of 0 indicates no preference of one treatment over the other.","Week 4","clinicaltrialdisclosure@sunovion.com","CNS Medical Director","1-866-503-6351","Innsbruck, Austria, A-6020|Marseille, France, 13385|Beelitz-Heilstatten, Germany, 14547|Cassino, Italy, 03043|Barcelona, Spain, 08036|London, United Kingdom, Se5 9Rs",null,"Austria|France|Germany|Italy|Spain|United Kingdom","Medical University Innsbruck, Neurolgy Dept|Hopital La Timone, Neurologie Et Pathologie Due Mouvement|Klinken Beelitz Gmbh Neurologisches Fachkrankenhaus Fur Bewegungsstorungen/Parkinson|San Raffaele Cassino|Hospital Clinic De Barcelona|King's College Hospital Nhs Foundation Trust",{"$nulls":3},"CNS Medical Director","2019-06-05","2020-05-25T16:35:27.294","2020-05-26T17:10:42.972","NCT03391882"]
["5ecbf3cffe30261b1a0481bf","NCT03391882","2019-06-21","Sunovion","SEPR","Recruiting","A Study of an Investigational Drug to See How it Affects the People With Parkinson's Disease Complicated by Motor Fluctuations (\"OFF\" Episodes) Compared to an Approved Drug Used to Treat People With Parkinson's Disease Complicated by Motor Fluctuations (\"OFF\" Episodes)","Apomorphine","DS Agonist","No",null,"No",null,"Phase 3",2,106,"Anticipated","2018-12-19","2020-03-24",{"$nulls":5},"A study of an investigational drug to see how it affects the people with Parkinson's Disease complicated by motor fluctuations (\"OFF\" Episodes) compared to an approved drug used to treat people with Parkinson's Disease complicated by motor fluctuations (\"OFF\" Episodes)","An Open-Label, Randomized, Crossover Trial utilizing a Single-Blinded Rater to evaluate APL-130277 compared to s.c. Apomorphine in Levodopa Responsive Subjects with Parkinson's Disease Complicated by Motor Fluctuations.\n\nPART A consists of an open label, crossover titration phase where eligible subjects will be randomized to 1 of 2 treatment sequences in a 1:1 ratio to Sublingual APL 130277 followed by subcutaneous apomorphine or subcutaneous apomorphine followed by sublingual APL 130277. Subjects will undergo dose titration with the first study treatment (APL 130277 or sc apomorphine) to tolerance and effect, ie, the tolerable dose that turns the subject from the practically defined \"OFF\" state to the full \"ON\" state as determined by both the Investigator and subject. The subject will then be crossed over to the other study treatment (APL 130277 or subcutaneous apomorphine) and similarly titrated to tolerance and effect. These determined doses of APL 130277 and subcutaneous apomorphine will be used during PART B.\n\nPART B consists of an open-label, crossover treatment period where subjects will be randomized to one of the study treatment for 4 weeks, then be crossed over to the other study treatment (APL-130277 or sc apomorphine) for additional 4-weeks of open-label treatment. Subjects return to the clinic for safety and efficacy assessments throughout the treatment period.\n\nThis study is designed to test the superiority of sublingually administered APL-130277 against subcutaneously injected apomorphine (APO-go) for the treatment of \"OFF\" episodes in patients with Parkinson's Disease, as measured by the change from pre-dose to 90 minutes post-dose in MDS UPDRS Part III score in Part B after 4 weeks of dosing in each crossover period.","An Open-Label, Randomized, Crossover Trial Utilizing a Single-Blinded Rater to Evaluate APL-130277 Compared to Subcutaneous Apomorphine in Levodopa Responsive Subjects With Parkinson's Disease Complicated by Motor Fluctuations","CTH-302","Motor OFF Episodes Associated With Parkinson's Disease","Parkinson Disease","Central Nervous System Diseases","Central Nervous System","Experimental|Active Comparator","APL-130277|subcutaneous apomorphine","APL-130277: Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A|subcutaneous apomorphine , Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A","Drug","APL-130277|subcutaneous apomorphine","APL-130277: Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A|subcutaneous apomorphine Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A","Apomorphine Hydrochloride|APO-goÂ®","APL-130277|subcutaneous apomorphine","\n\n 1.  The subject (and caregiver, if applicable) must be fully informed of and understand the objectives, procedures, and possible benefits and risks of the study, and give written informed consent prior to performing any study related activities.\n 2.  Male or female â‰¥ 18 years of age.\n 3.  Clinical diagnosis of Idiopathic PD, consistent with UK Brain Bank Criteria (excluding the \"more than one affected relative\" criterion).\n 4.  Clinically meaningful response to levodopa (L-Dopa), as determined by the Investigator.\n 5.  Subjects at screening must demonstrate an adequate L-Dopa response on the MDS UPDRS Part III in the \"ON\" state compared to the MDS UPDRS Part III in the \"OFF\" state and on the Hoehn and Yahr, as determined during the review by Enrollment Adjudication Committee (EAC), Sponsor, and Medical Monitor.\n 6.  Receiving stable doses of L Dopa/carbidopa and/or L Dopa/benserazide and/or L Dopa/carbidopa/entacapone (immediate or chronic release) administered at least 4 times per day OR Rytaryâ„¢ administered at least 3 times per day for at least 4 weeks before the initial screening Visit (SV1). Adjunctive PD medication regimens are permitted but must be maintained at a stable dose for at least 4 weeks prior to SV1 with the exception of monoamine oxidase B (MAO B) inhibitors, which must be maintained at a stable level for at least 8 weeks prior to SV1.\n 7.  No planned medication change(s) or surgical intervention anticipated during the course of study.\n 8.  Subjects must experience at least one well defined \"OFF\" episode per day and have a total daily \"OFF\" time duration of > 2 hours during the waking day, based on judgment of physician and subject self assessment.\n 9.  Subject must have predictable morning \"OFF\" periods, based on judgment of physician and subject self assessment.\n 10. Subject, and where appropriate caregiver, must be trained in completing the home dosing diaries and able to recognize \"ON\" and \"OFF\" states.\n 11. Stage III or less on the modified Hoehn and Yahr scale in the \"ON\" state.\n 12. Mini-Mental State Examination (MMSE) score > 25.\n 13. Female subject of childbearing potential and male subject with female partner of childbearing potential must agree to either remain abstinent or use adequate and reliable contraception throughout the study and for at least 7 days after the last dose of study drug has been taken. Note: Continued use of adequate and reliable contraception is recommended through 30 days after study completion.\n 14. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study related procedures to complete the study.\n 15. Must be approved as a satisfactory candidate by the Enrollment Adjudication Committee (EAC), Medical Monitor, and Sponsor.\n\n","\n\n 1.  Atypical or secondary parkinsonism.\n 2.  Major focal brain disorders including malignancy or stroke.\n 3.  Prior treatment with any of the following: a neurosurgical procedure for PD; continuous subcutaneous (subcutaneous) apomorphine infusion; subcutaneous (subcutaneous) apomorphine injection; Duodopa/Duopa; or APL-130277.\n 4.  Contraindications to domperidone, subcutaneous apomorphine, or hypersensitivity to apomorphine hydrochloride or any of the ingredients of subcutaneous apomorphine (notably sodium metabisulfite).\n 5.  Female who is pregnant or lactating.\n 6.  Participation in an interventional clinical study and/or receipt of any investigational (ie, unapproved) medication within 30 days prior to SV1.\n 7.  Currently taking selective 5HT3 antagonists (ie, ondansetron, granisetron, dolasetron, palonosetron, alosetron), dopamine antagonists (excluding quetiapine or clozapine) or dopamine depleting agents. Subjects receiving anti depressants must be on a stable daily dose for at least 8 weeks prior to SV1.\n 8.  The subject has a current diagnosis or history of substance abuse (excluding nicotine and caffeine) or alcohol abuse (in the opinion of the investigator) < 6 months prior to SV1.\n 9.  The recreational use of cannabinoids and hallucinogenic are excluded, as well any use of a sublingual formulation of any drug.\n 10. Subject has a history of malignancy within 5 years prior to SV1, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.\n 11. Subject has a clinically significant abnormality on screening evaluation including physical examination, vital signs, electrocardiogram (ECG), or laboratory tests that the Investigator considers to be inappropriate to allow participation in the study.\n 12. Subject has screening laboratory test results of: blood urea nitrogen (BUN) value â‰¥ 1.5 times the upper limit of normal (ULN) for the reference range; serum creatinine > 1.5 times the ULN for the reference range; or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value â‰¥ 2 times the ULN for the reference laboratory.\n 13. Subject has random (non-fasting) screening glucose of â‰¥ 200 mg/dL (11.1 mmol/L) or HbA1c > 7.0%.\n 14. Subjects with type 1 diabetes, or insulin dependent diabetics are excluded. Subjects with type 2 diabetes are eligible for study inclusion if the following conditions are met: * Subject's screening glucose is < 200 mg/dL (11.1 mmol/L). Note: Subjects with random (non fasting) blood glucose at screening â‰¥ 200 mg/dL (11.1 mmol/L) must be retested in a fasted state; and\n      * Subject's hemoglobin A1c (HbA1c) â‰¤ 7.0%; and\n      * If the subject is currently being treated with oral anti-diabetic medication(s), the dose must have been stable for at least 4 weeks prior to SV1. Such medication may be adjusted or discontinued during the study, as clinically indicated.\n     \n     \n 15. The subject's screening ECG results of corrected QT interval using Fridericia's formula (QTcF) â‰¥ 450 msec for male subjects or â‰¥ 470 msec for female subjects. Eligibility will be based on the core laboratory ECG interpretation report.\n 16. Subject has a positive screening laboratory test result for human immunodeficiency virus (HIV).\n 17. Subject has a positive screening laboratory test result for hepatitis B surface antigen or hepatitis C antibodies and has liver function test results at screening above the ULN for the reference laboratory.\n 18. Subject has any other medical disorder that, in the opinion of the Investigator, could interfere with the subject's participation in the study.\n 19. Subject has major psychiatric disorder(s), including but not limited to: bipolar disorder, psychosis (eg, Parkinson's Disease Psychosis), major depressive episode, or any disorder that, in the opinion of the Investigator, would require treatment that could make study participation unsafe or make treatment compliance difficult.\n 20. History of clinically significant impulse control disorder(s).\n 21. History of symptomatic orthostatic hypotension requiring medication.\n 22. History of severe dyskinesia based on a score of 4 on the MDS-UPDRS Part IV.\n 23. Dementia that precludes providing informed consent or would interfere with participation in the study.\n 24. Current/recent suicidal ideation as evidenced by answering \"yes\" to \"Suicidal Ideation\" item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) on the C-SSRS assessment at screening (using the \"screening /Baseline Version\" scale, in the past 12 months) or attempted suicide within the last 5 years.\n 25. Presence of canker or mouth sores in the 30 days prior to SV1, or other clinically significant oral pathology in the opinion of the Investigator. The Investigator should follow-up with an appropriate specialist on any finding, if indicated, before enrolling a subject into the study","MAOB","monoamine oxidase B","Gene","Prostate","Actual","2018-01-05","Actual","Anticipated","2020-03-24","Anticipated","2019-06-01","2018-01-02","2018-01-02","2019-06-20","No","Parkinson's Disease\n\"Off\" Episodes\nmotor fluctuations associated with Parkinson's Disease","Interventional","Treatment","Crossover Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":4},"Yes",{"$nulls":12},"2016-003456-70","EudraCT Number","change from pre-dose to 90 minutes post-dose in MDS UPDRS Part III score after 4 weeks of dosing in each crossover period (assessed by the blinded-rater in-clinic at Visit 3 and Visit 6 of PART B).","Week 4",null,"Durability of effect, defined as an Investigator confirmed full \"ON\" within 30 minutes post dose and at 90 minutes post-dose, after 4 weeks of dosing in each crossover period (assessed by the blinded-rater in-clinic at Visit 3 and Visit 6 of PART B).|Subject preference for treatment regimen as measured by the Subject Preference Visual Analog Scale (VAS) after the subject has completed both APL 130277 and sc apomorphine treatment regimens (assessed in-clinic at Visit 6 of PART B).|Per the Expanded Home Dosing Diary, percent of \"ON\" episodes without troublesome dyskinesia based on the 3 consecutive days prior to Visit 2, Visit 3, Visit 5, and Visit 6.|Subject confirmed durability of effect, defined as subject confirmed full \"ON\" within 30 minutes post-dose and at 90 minutes post-dose, after 4 weeks of dosing in each crossover period (assessed in-clinic at Visit 3 and Visit 6 of PART B).|Patient Global Impression of Change (PGI-C): Subject improvement of \"OFF\" episodes, defined as very much better, much better or a little better after 4 weeks of dosing in each crossover period (assessed in-clinic at Visit 3 and Visit 6 of PART B).","Week 4|with a recorded range of -50 to 50. Negative values indicate preference for SC treatment, and the more negative the value, the stronger is the preference for SC compared to APL treatment. Positive values indicate preference for APL treatment, and the more positive the value, the stronger is the preference for APL compared to SC treatment. A value of 0 indicates no preference of one treatment over the other.","Week 4","clinicaltrialdisclosure@sunovion.com","CNS Medical Director","1-866-503-6351","Innsbruck, Austria, A-6020|Marseille, France, 13385|Beelitz-Heilstatten, Germany, 14547|Cassino, Italy, 03043|Barcelona, Spain, 08036|London, United Kingdom, Se5 9Rs",null,"Austria|France|Germany|Italy|Spain|United Kingdom","Medical University Innsbruck, Neurolgy Dept|Hopital La Timone, Neurologie Et Pathologie Due Mouvement|Klinken Beelitz Gmbh Neurologisches Fachkrankenhaus Fur Bewegungsstorungen/Parkinson|San Raffaele Cassino|Hospital Clinic De Barcelona|King's College Hospital Nhs Foundation Trust",{"$nulls":3},"CNS Medical Director","2019-06-20","2020-05-25T16:35:27.496","2020-05-26T17:10:42.972","NCT03391882"]
["5ecbf3cf307e3d1b1f8d9c4f","NCT03391882","2019-09-25","Sunovion","SEPR","Recruiting","A Study of an Investigational Drug to See How it Affects the People With Parkinson's Disease Complicated by Motor Fluctuations (\"OFF\" Episodes) Compared to an Approved Drug Used to Treat People With Parkinson's Disease Complicated by Motor Fluctuations (\"OFF\" Episodes)","Apomorphine","DS Agonist","No",null,"No",null,"Phase 3",2,106,"Anticipated","2018-12-19","2020-03-24",{"$nulls":5},"A study of an investigational drug to see how it affects the people with Parkinson's Disease complicated by motor fluctuations (\"OFF\" Episodes) compared to an approved drug used to treat people with Parkinson's Disease complicated by motor fluctuations (\"OFF\" Episodes)","An Open-Label, Randomized, Crossover Trial utilizing a Single-Blinded Rater to evaluate APL-130277 compared to s.c. Apomorphine in Levodopa Responsive Subjects with Parkinson's Disease Complicated by Motor Fluctuations.\n\nPART A consists of an open label, crossover titration phase where eligible subjects will be randomized to 1 of 2 treatment sequences in a 1:1 ratio to Sublingual APL 130277 followed by subcutaneous apomorphine or subcutaneous apomorphine followed by sublingual APL 130277. Subjects will undergo dose titration with the first study treatment (APL 130277 or sc apomorphine) to tolerance and effect, ie, the tolerable dose that turns the subject from the practically defined \"OFF\" state to the full \"ON\" state as determined by both the Investigator and subject. The subject will then be crossed over to the other study treatment (APL 130277 or subcutaneous apomorphine) and similarly titrated to tolerance and effect. These determined doses of APL 130277 and subcutaneous apomorphine will be used during PART B.\n\nPART B consists of an open-label, crossover treatment period where subjects will be randomized to one of the study treatment for 4 weeks, then be crossed over to the other study treatment (APL-130277 or sc apomorphine) for additional 4-weeks of open-label treatment. Subjects return to the clinic for safety and efficacy assessments throughout the treatment period.\n\nThis study is designed to test the superiority of sublingually administered APL-130277 against subcutaneously injected apomorphine (APO-go) for the treatment of \"OFF\" episodes in patients with Parkinson's Disease, as measured by the change from pre-dose to 90 minutes post-dose in MDS UPDRS Part III score in Part B after 4 weeks of dosing in each crossover period.","An Open-Label, Randomized, Crossover Trial Utilizing a Single-Blinded Rater to Evaluate APL-130277 Compared to Subcutaneous Apomorphine in Levodopa Responsive Subjects With Parkinson's Disease Complicated by Motor Fluctuations","CTH-302","Motor OFF Episodes Associated With Parkinson's Disease","Parkinson Disease","Central Nervous System Diseases","Central Nervous System","Experimental|Active Comparator","APL-130277|subcutaneous apomorphine","APL-130277: Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A|subcutaneous apomorphine , Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A","Drug","APL-130277|subcutaneous apomorphine","APL-130277: Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A|subcutaneous apomorphine Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A","Apomorphine Hydrochloride|APO-goÂ®","APL-130277|subcutaneous apomorphine","\n\n 1.  The subject (and caregiver, if applicable) must be fully informed of and understand the objectives, procedures, and possible benefits and risks of the study, and give written informed consent prior to performing any study related activities.\n 2.  Male or female â‰¥ 18 years of age.\n 3.  Clinical diagnosis of Idiopathic PD, consistent with UK Brain Bank Criteria (excluding the \"more than one affected relative\" criterion).\n 4.  Clinically meaningful response to levodopa (L-Dopa), as determined by the Investigator.\n 5.  Subjects at screening must demonstrate an adequate L-Dopa response on the MDS UPDRS Part III in the \"ON\" state compared to the MDS UPDRS Part III in the \"OFF\" state and on the Hoehn and Yahr, as determined during the review by Enrollment Adjudication Committee (EAC), Sponsor, and Medical Monitor.\n 6.  Receiving stable doses of L Dopa/carbidopa and/or L Dopa/benserazide and/or L Dopa/carbidopa/entacapone (immediate or chronic release) administered at least 4 times per day OR Rytaryâ„¢ administered at least 3 times per day for at least 4 weeks before the initial screening Visit (SV1). Adjunctive PD medication regimens are permitted but must be maintained at a stable dose for at least 4 weeks prior to SV1 with the exception of monoamine oxidase B (MAO B) inhibitors, which must be maintained at a stable level for at least 8 weeks prior to SV1.\n 7.  No planned medication change(s) or surgical intervention anticipated during the course of study.\n 8.  Subjects must experience at least one well defined \"OFF\" episode per day and have a total daily \"OFF\" time duration of > 2 hours during the waking day, based on judgment of physician and subject self assessment.\n 9.  Subject must have predictable morning \"OFF\" periods, based on judgment of physician and subject self assessment.\n 10. Subject, and where appropriate caregiver, must be trained in completing the home dosing diaries and able to recognize \"ON\" and \"OFF\" states.\n 11. Stage III or less on the modified Hoehn and Yahr scale in the \"ON\" state.\n 12. Mini-Mental State Examination (MMSE) score > 25.\n 13. Female subject of childbearing potential and male subject with female partner of childbearing potential must agree to either remain abstinent or use adequate and reliable contraception throughout the study and for at least 7 days after the last dose of study drug has been taken. Note: Continued use of adequate and reliable contraception is recommended through 30 days after study completion.\n 14. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study related procedures to complete the study.\n 15. Must be approved as a satisfactory candidate by the Enrollment Adjudication Committee (EAC), Medical Monitor, and Sponsor.\n\n","\n\n 1.  Atypical or secondary parkinsonism.\n 2.  Major focal brain disorders including malignancy or stroke.\n 3.  Prior treatment with any of the following: a neurosurgical procedure for PD; continuous subcutaneous (subcutaneous) apomorphine infusion; subcutaneous (subcutaneous) apomorphine injection; Duodopa/Duopa; or APL-130277.\n 4.  Contraindications to domperidone, subcutaneous apomorphine, or hypersensitivity to apomorphine hydrochloride or any of the ingredients of subcutaneous apomorphine (notably sodium metabisulfite).\n 5.  Female who is pregnant or lactating.\n 6.  Participation in an interventional clinical study and/or receipt of any investigational (ie, unapproved) medication within 30 days prior to SV1.\n 7.  Currently taking selective 5HT3 antagonists (ie, ondansetron, granisetron, dolasetron, palonosetron, alosetron), dopamine antagonists (excluding quetiapine or clozapine) or dopamine depleting agents. Subjects receiving anti depressants must be on a stable daily dose for at least 8 weeks prior to SV1.\n 8.  The subject has a current diagnosis or history of substance abuse (excluding nicotine and caffeine) or alcohol abuse (in the opinion of the investigator) < 6 months prior to SV1.\n 9.  The recreational use of cannabinoids and hallucinogenic are excluded, as well any use of a sublingual formulation of any drug.\n 10. Subject has a history of malignancy within 5 years prior to SV1, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.\n 11. Subject has a clinically significant abnormality on screening evaluation including physical examination, vital signs, electrocardiogram (ECG), or laboratory tests that the Investigator considers to be inappropriate to allow participation in the study.\n 12. Subject has screening laboratory test results of: blood urea nitrogen (BUN) value â‰¥ 1.5 times the upper limit of normal (ULN) for the reference range; serum creatinine > 1.5 times the ULN for the reference range; or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value â‰¥ 2 times the ULN for the reference laboratory.\n 13. Subject has random (non-fasting) screening glucose of â‰¥ 200 mg/dL (11.1 mmol/L) or HbA1c > 7.0%.\n 14. Subjects with type 1 diabetes, or insulin dependent diabetics are excluded. Subjects with type 2 diabetes are eligible for study inclusion if the following conditions are met: * Subject's screening glucose is < 200 mg/dL (11.1 mmol/L). Note: Subjects with random (non fasting) blood glucose at screening â‰¥ 200 mg/dL (11.1 mmol/L) must be retested in a fasted state; and\n      * Subject's hemoglobin A1c (HbA1c) â‰¤ 7.0%; and\n      * If the subject is currently being treated with oral anti-diabetic medication(s), the dose must have been stable for at least 4 weeks prior to SV1. Such medication may be adjusted or discontinued during the study, as clinically indicated.\n     \n     \n 15. The subject's screening ECG results of corrected QT interval using Fridericia's formula (QTcF) â‰¥ 450 msec for male subjects or â‰¥ 470 msec for female subjects. Eligibility will be based on the core laboratory ECG interpretation report.\n 16. Subject has a positive screening laboratory test result for human immunodeficiency virus (HIV).\n 17. Subject has a positive screening laboratory test result for hepatitis B surface antigen or hepatitis C antibodies and has liver function test results at screening above the ULN for the reference laboratory.\n 18. Subject has any other medical disorder that, in the opinion of the Investigator, could interfere with the subject's participation in the study.\n 19. Subject has major psychiatric disorder(s), including but not limited to: bipolar disorder, psychosis (eg, Parkinson's Disease Psychosis), major depressive episode, or any disorder that, in the opinion of the Investigator, would require treatment that could make study participation unsafe or make treatment compliance difficult.\n 20. History of clinically significant impulse control disorder(s).\n 21. History of symptomatic orthostatic hypotension requiring medication.\n 22. History of severe dyskinesia based on a score of 4 on the MDS-UPDRS Part IV.\n 23. Dementia that precludes providing informed consent or would interfere with participation in the study.\n 24. Current/recent suicidal ideation as evidenced by answering \"yes\" to \"Suicidal Ideation\" item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) on the C-SSRS assessment at screening (using the \"screening /Baseline Version\" scale, in the past 12 months) or attempted suicide within the last 5 years.\n 25. Presence of canker or mouth sores in the 30 days prior to SV1, or other clinically significant oral pathology in the opinion of the Investigator. The Investigator should follow-up with an appropriate specialist on any finding, if indicated, before enrolling a subject into the study","MAOB","monoamine oxidase B","Gene","Prostate","Actual","2018-01-05","Actual","Anticipated","2020-03-24","Anticipated","2019-09-01","2018-01-02","2018-01-02","2019-09-24","No","Parkinson's Disease\n\"Off\" Episodes\nmotor fluctuations associated with Parkinson's Disease","Interventional","Treatment","Crossover Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":4},"Yes",{"$nulls":12},"2016-003456-70","EudraCT Number","change from pre-dose to 90 minutes post-dose in MDS UPDRS Part III score after 4 weeks of dosing in each crossover period (assessed by the blinded-rater in-clinic at Visit 3 and Visit 6 of PART B).","Week 4",null,"Durability of effect, defined as an Investigator confirmed full \"ON\" within 30 minutes post dose and at 90 minutes post-dose, after 4 weeks of dosing in each crossover period (assessed by the blinded-rater in-clinic at Visit 3 and Visit 6 of PART B).|Subject preference for treatment regimen as measured by the Subject Preference Visual Analog Scale (VAS) after the subject has completed both APL 130277 and sc apomorphine treatment regimens (assessed in-clinic at Visit 6 of PART B).|Per the Expanded Home Dosing Diary, percent of \"ON\" episodes without troublesome dyskinesia based on the 3 consecutive days prior to Visit 2, Visit 3, Visit 5, and Visit 6.|Subject confirmed durability of effect, defined as subject confirmed full \"ON\" within 30 minutes post-dose and at 90 minutes post-dose, after 4 weeks of dosing in each crossover period (assessed in-clinic at Visit 3 and Visit 6 of PART B).|Patient Global Impression of Change (PGI-C): Subject improvement of \"OFF\" episodes, defined as very much better, much better or a little better after 4 weeks of dosing in each crossover period (assessed in-clinic at Visit 3 and Visit 6 of PART B).","Week 4|with a recorded range of -50 to 50. Negative values indicate preference for SC treatment, and the more negative the value, the stronger is the preference for SC compared to APL treatment. Positive values indicate preference for APL treatment, and the more positive the value, the stronger is the preference for APL compared to SC treatment. A value of 0 indicates no preference of one treatment over the other.","Week 4","clinicaltrialdisclosure@sunovion.com","CNS Medical Director","1-866-503-6351","Innsbruck, Austria, A-6020|Marseille, France, 13385|Beelitz-Heilstatten, Germany, 14547|Cassino, Italy, 03043|Barcelona, Spain, 08036|London, United Kingdom, Se5 9Rs",null,"Austria|France|Germany|Italy|Spain|United Kingdom","Medical University Innsbruck, Neurolgy Dept|Hopital La Timone, Neurologie Et Pathologie Due Mouvement|Klinken Beelitz Gmbh Neurologisches Fachkrankenhaus Fur Bewegungsstorungen/Parkinson|San Raffaele Cassino|Hospital Clinic De Barcelona|King's College Hospital Nhs Foundation Trust",{"$nulls":3},"CNS Medical Director","2019-09-24","2020-05-25T16:35:27.262","2020-05-26T17:10:42.972","NCT03391882"]
["5ecbf3cfe2561b1b11905cbb","NCT03391882","2019-11-01","Sunovion","SEPR","Recruiting","A Study of an Investigational Drug to See How it Affects the People With Parkinson's Disease Complicated by Motor Fluctuations (\"OFF\" Episodes) Compared to an Approved Drug Used to Treat People With Parkinson's Disease Complicated by Motor Fluctuations (\"OFF\" Episodes)","Apomorphine","DS Agonist","No",null,"No",null,"Phase 3",2,106,"Anticipated","2018-12-19","2020-03-24",{"$nulls":5},"A study of an investigational drug to see how it affects the people with Parkinson's Disease complicated by motor fluctuations (\"OFF\" Episodes) compared to an approved drug used to treat people with Parkinson's Disease complicated by motor fluctuations (\"OFF\" Episodes)","An Open-Label, Randomized, Crossover Trial utilizing a Single-Blinded Rater to evaluate APL-130277 compared to s.c. Apomorphine in Levodopa Responsive Subjects with Parkinson's Disease Complicated by Motor Fluctuations.\n\nPART A consists of an open label, crossover titration phase where eligible subjects will be randomized to 1 of 2 treatment sequences in a 1:1 ratio to Sublingual APL 130277 followed by subcutaneous apomorphine or subcutaneous apomorphine followed by sublingual APL 130277. Subjects will undergo dose titration with the first study treatment (APL 130277 or sc apomorphine) to tolerance and effect, ie, the tolerable dose that turns the subject from the practically defined \"OFF\" state to the full \"ON\" state as determined by both the Investigator and subject. The subject will then be crossed over to the other study treatment (APL 130277 or subcutaneous apomorphine) and similarly titrated to tolerance and effect. These determined doses of APL 130277 and subcutaneous apomorphine will be used during PART B.\n\nPART B consists of an open-label, crossover treatment period where subjects will be randomized to one of the study treatment for 4 weeks, then be crossed over to the other study treatment (APL-130277 or sc apomorphine) for additional 4-weeks of open-label treatment. Subjects return to the clinic for safety and efficacy assessments throughout the treatment period.\n\nThis study is designed to test the superiority of sublingually administered APL-130277 against subcutaneously injected apomorphine (APO-go) for the treatment of \"OFF\" episodes in patients with Parkinson's Disease, as measured by the change from pre-dose to 90 minutes post-dose in MDS UPDRS Part III score in Part B after 4 weeks of dosing in each crossover period.","An Open-Label, Randomized, Crossover Trial Utilizing a Single-Blinded Rater to Evaluate APL-130277 Compared to Subcutaneous Apomorphine in Levodopa Responsive Subjects With Parkinson's Disease Complicated by Motor Fluctuations","CTH-302","Motor OFF Episodes Associated With Parkinson's Disease","Parkinson Disease","Central Nervous System Diseases","Central Nervous System","Experimental|Active Comparator","APL-130277|subcutaneous apomorphine","APL-130277: Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A|subcutaneous apomorphine , Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A","Drug","APL-130277|subcutaneous apomorphine","APL-130277: Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A|subcutaneous apomorphine Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A","Apomorphine Hydrochloride|APO-goÂ®","APL-130277|subcutaneous apomorphine","\n\n 1.  The subject (and caregiver, if applicable) must be fully informed of and understand the objectives, procedures, and possible benefits and risks of the study, and give written informed consent prior to performing any study related activities.\n 2.  Male or female â‰¥ 18 years of age.\n 3.  Clinical diagnosis of Idiopathic PD, consistent with UK Brain Bank Criteria (excluding the \"more than one affected relative\" criterion).\n 4.  Clinically meaningful response to levodopa (L-Dopa), as determined by the Investigator.\n 5.  Subjects at screening must demonstrate an adequate L-Dopa response on the MDS UPDRS Part III in the \"ON\" state compared to the MDS UPDRS Part III in the \"OFF\" state and on the Hoehn and Yahr, as determined during the review by Enrollment Adjudication Committee (EAC), Sponsor, and Medical Monitor.\n 6.  Receiving stable doses of L Dopa/carbidopa and/or L Dopa/benserazide and/or L Dopa/carbidopa/entacapone (immediate or chronic release) administered at least 4 times per day OR Rytaryâ„¢ administered at least 3 times per day for at least 4 weeks before the initial screening Visit (SV1). Adjunctive PD medication regimens are permitted but must be maintained at a stable dose for at least 4 weeks prior to SV1 with the exception of monoamine oxidase B (MAO B) inhibitors, which must be maintained at a stable level for at least 8 weeks prior to SV1.\n 7.  No planned medication change(s) or surgical intervention anticipated during the course of study.\n 8.  Subjects must experience at least one well defined \"OFF\" episode per day and have a total daily \"OFF\" time duration of > 2 hours during the waking day, based on judgment of physician and subject self assessment.\n 9.  Subject must have predictable morning \"OFF\" periods, based on judgment of physician and subject self assessment.\n 10. Subject, and where appropriate caregiver, must be trained in completing the home dosing diaries and able to recognize \"ON\" and \"OFF\" states.\n 11. Stage III or less on the modified Hoehn and Yahr scale in the \"ON\" state.\n 12. Mini-Mental State Examination (MMSE) score > 25.\n 13. Female subject of childbearing potential and male subject with female partner of childbearing potential must agree to either remain abstinent or use adequate and reliable contraception throughout the study and for at least 7 days after the last dose of study drug has been taken. Note: Continued use of adequate and reliable contraception is recommended through 30 days after study completion.\n 14. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study related procedures to complete the study.\n 15. Must be approved as a satisfactory candidate by the Enrollment Adjudication Committee (EAC), Medical Monitor, and Sponsor.\n\n","\n\n 1.  Atypical or secondary parkinsonism.\n 2.  Major focal brain disorders including malignancy or stroke.\n 3.  Prior treatment with any of the following: a neurosurgical procedure for PD; continuous subcutaneous (subcutaneous) apomorphine infusion; subcutaneous (subcutaneous) apomorphine injection; Duodopa/Duopa; or APL-130277.\n 4.  Contraindications to domperidone, subcutaneous apomorphine, or hypersensitivity to apomorphine hydrochloride or any of the ingredients of subcutaneous apomorphine (notably sodium metabisulfite).\n 5.  Female who is pregnant or lactating.\n 6.  Participation in an interventional clinical study and/or receipt of any investigational (ie, unapproved) medication within 30 days prior to SV1.\n 7.  Currently taking selective 5HT3 antagonists (ie, ondansetron, granisetron, dolasetron, palonosetron, alosetron), dopamine antagonists (excluding quetiapine or clozapine) or dopamine depleting agents. Subjects receiving anti depressants must be on a stable daily dose for at least 8 weeks prior to SV1.\n 8.  The subject has a current diagnosis or history of substance abuse (excluding nicotine and caffeine) or alcohol abuse (in the opinion of the investigator) < 6 months prior to SV1.\n 9.  The recreational use of cannabinoids and hallucinogenic are excluded, as well any use of a sublingual formulation of any drug.\n 10. Subject has a history of malignancy within 5 years prior to SV1, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.\n 11. Subject has a clinically significant abnormality on screening evaluation including physical examination, vital signs, electrocardiogram (ECG), or laboratory tests that the Investigator considers to be inappropriate to allow participation in the study.\n 12. Subject has screening laboratory test results of: blood urea nitrogen (BUN) value â‰¥ 1.5 times the upper limit of normal (ULN) for the reference range; serum creatinine > 1.5 times the ULN for the reference range; or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value â‰¥ 2 times the ULN for the reference laboratory.\n 13. Subject has random (non-fasting) screening glucose of â‰¥ 200 mg/dL (11.1 mmol/L) or HbA1c > 7.0%.\n 14. Subjects with type 1 diabetes, or insulin dependent diabetics are excluded. Subjects with type 2 diabetes are eligible for study inclusion if the following conditions are met: * Subject's screening glucose is < 200 mg/dL (11.1 mmol/L). Note: Subjects with random (non fasting) blood glucose at screening â‰¥ 200 mg/dL (11.1 mmol/L) must be retested in a fasted state; and\n      * Subject's hemoglobin A1c (HbA1c) â‰¤ 7.0%; and\n      * If the subject is currently being treated with oral anti-diabetic medication(s), the dose must have been stable for at least 4 weeks prior to SV1. Such medication may be adjusted or discontinued during the study, as clinically indicated.\n     \n     \n 15. The subject's screening ECG results of corrected QT interval using Fridericia's formula (QTcF) â‰¥ 450 msec for male subjects or â‰¥ 470 msec for female subjects. Eligibility will be based on the core laboratory ECG interpretation report.\n 16. Subject has a positive screening laboratory test result for human immunodeficiency virus (HIV).\n 17. Subject has a positive screening laboratory test result for hepatitis B surface antigen or hepatitis C antibodies and has liver function test results at screening above the ULN for the reference laboratory.\n 18. Subject has any other medical disorder that, in the opinion of the Investigator, could interfere with the subject's participation in the study.\n 19. Subject has major psychiatric disorder(s), including but not limited to: bipolar disorder, psychosis (eg, Parkinson's Disease Psychosis), major depressive episode, or any disorder that, in the opinion of the Investigator, would require treatment that could make study participation unsafe or make treatment compliance difficult.\n 20. History of clinically significant impulse control disorder(s).\n 21. History of symptomatic orthostatic hypotension requiring medication.\n 22. History of severe dyskinesia based on a score of 4 on the MDS-UPDRS Part IV.\n 23. Dementia that precludes providing informed consent or would interfere with participation in the study.\n 24. Current/recent suicidal ideation as evidenced by answering \"yes\" to \"Suicidal Ideation\" item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) on the C-SSRS assessment at screening (using the \"screening /Baseline Version\" scale, in the past 12 months) or attempted suicide within the last 5 years.\n 25. Presence of canker or mouth sores in the 30 days prior to SV1, or other clinically significant oral pathology in the opinion of the Investigator. The Investigator should follow-up with an appropriate specialist on any finding, if indicated, before enrolling a subject into the study","MAOB","monoamine oxidase B","Gene","Prostate","Actual","2018-01-05","Actual","Anticipated","2020-03-24","Anticipated","2019-10-01","2018-01-02","2018-01-02","2019-10-30","No","Parkinson's Disease\n\"Off\" Episodes\nmotor fluctuations associated with Parkinson's Disease","Interventional","Treatment","Crossover Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No","Yes\nIPD for this study may be made available upon request via the Clinical Study Data Request site.",{"$nulls":3},"Yes","No",{"$nulls":4},"Yes",{"$nulls":12},"2016-003456-70","EudraCT Number","change from pre-dose to 90 minutes post-dose in MDS UPDRS Part III score after 4 weeks of dosing in each crossover period (assessed by the blinded-rater in-clinic at Visit 3 and Visit 6 of PART B).","Week 4",null,"Durability of effect, defined as an Investigator confirmed full \"ON\" within 30 minutes post dose and at 90 minutes post-dose, after 4 weeks of dosing in each crossover period (assessed by the blinded-rater in-clinic at Visit 3 and Visit 6 of PART B).|Subject preference for treatment regimen as measured by the Subject Preference Visual Analog Scale (VAS) after the subject has completed both APL 130277 and sc apomorphine treatment regimens (assessed in-clinic at Visit 6 of PART B).|Per the Expanded Home Dosing Diary, percent of \"ON\" episodes without troublesome dyskinesia based on the 3 consecutive days prior to Visit 2, Visit 3, Visit 5, and Visit 6.|Subject confirmed durability of effect, defined as subject confirmed full \"ON\" within 30 minutes post-dose and at 90 minutes post-dose, after 4 weeks of dosing in each crossover period (assessed in-clinic at Visit 3 and Visit 6 of PART B).|Patient Global Impression of Change (PGI-C): Subject improvement of \"OFF\" episodes, defined as very much better, much better or a little better after 4 weeks of dosing in each crossover period (assessed in-clinic at Visit 3 and Visit 6 of PART B).","Week 4|with a recorded range of -50 to 50. Negative values indicate preference for SC treatment, and the more negative the value, the stronger is the preference for SC compared to APL treatment. Positive values indicate preference for APL treatment, and the more positive the value, the stronger is the preference for APL compared to SC treatment. A value of 0 indicates no preference of one treatment over the other.","Week 4","clinicaltrialdisclosure@sunovion.com","CNS Medical Director","1-866-503-6351","Innsbruck, Austria, A-6020|Marseille, France, 13385|Beelitz-Heilstatten, Germany, 14547|Cassino, Italy, 03043|Barcelona, Spain, 08036|London, United Kingdom, Se5 9Rs",null,"Austria|France|Germany|Italy|Spain|United Kingdom","Medical University Innsbruck, Neurolgy Dept|Hopital La Timone, Neurologie Et Pathologie Due Mouvement|Klinken Beelitz Gmbh Neurologisches Fachkrankenhaus Fur Bewegungsstorungen/Parkinson|San Raffaele Cassino|Hospital Clinic De Barcelona|King's College Hospital Nhs Foundation Trust",{"$nulls":3},"CNS Medical Director","2019-10-30","2020-05-25T16:35:27.776","2020-05-26T17:10:42.972","NCT03391882"]
["5ecbf3cffeab101b155307ef","NCT03391882","2019-11-21","Sunovion","SEPR","Recruiting","A Study of an Investigational Drug to See How it Affects the People With Parkinson's Disease Complicated by Motor Fluctuations (\"OFF\" Episodes) Compared to an Approved Drug Used to Treat People With Parkinson's Disease Complicated by Motor Fluctuations (\"OFF\" Episodes)","Apomorphine","DS Agonist","No",null,"No",null,"Phase 3",2,106,"Anticipated","2018-12-19","2020-03-24",{"$nulls":5},"A study of an investigational drug to see how it affects the people with Parkinson's Disease complicated by motor fluctuations (\"OFF\" Episodes) compared to an approved drug used to treat people with Parkinson's Disease complicated by motor fluctuations (\"OFF\" Episodes)","An Open-Label, Randomized, Crossover Trial utilizing a Single-Blinded Rater to evaluate APL-130277 compared to s.c. Apomorphine in Levodopa Responsive Subjects with Parkinson's Disease Complicated by Motor Fluctuations.\n\nPART A consists of an open label, crossover titration phase where eligible subjects will be randomized to 1 of 2 treatment sequences in a 1:1 ratio to Sublingual APL 130277 followed by subcutaneous apomorphine or subcutaneous apomorphine followed by sublingual APL 130277. Subjects will undergo dose titration with the first study treatment (APL 130277 or sc apomorphine) to tolerance and effect, ie, the tolerable dose that turns the subject from the practically defined \"OFF\" state to the full \"ON\" state as determined by both the Investigator and subject. The subject will then be crossed over to the other study treatment (APL 130277 or subcutaneous apomorphine) and similarly titrated to tolerance and effect. These determined doses of APL 130277 and subcutaneous apomorphine will be used during PART B.\n\nPART B consists of an open-label, crossover treatment period where subjects will be randomized to one of the study treatment for 4 weeks, then be crossed over to the other study treatment (APL-130277 or sc apomorphine) for additional 4-weeks of open-label treatment. Subjects return to the clinic for safety and efficacy assessments throughout the treatment period.\n\nThis study is designed to test the superiority of sublingually administered APL-130277 against subcutaneously injected apomorphine (APO-go) for the treatment of \"OFF\" episodes in patients with Parkinson's Disease, as measured by the change from pre-dose to 90 minutes post-dose in MDS UPDRS Part III score in Part B after 4 weeks of dosing in each crossover period.","An Open-Label, Randomized, Crossover Trial Utilizing a Single-Blinded Rater to Evaluate APL-130277 Compared to Subcutaneous Apomorphine in Levodopa Responsive Subjects With Parkinson's Disease Complicated by Motor Fluctuations","CTH-302","Motor OFF Episodes Associated With Parkinson's Disease","Parkinson Disease","Central Nervous System Diseases","Central Nervous System","Experimental|Active Comparator","APL-130277|subcutaneous apomorphine","APL-130277: Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A|subcutaneous apomorphine , Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A","Drug","APL-130277|subcutaneous apomorphine","APL-130277: Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A|subcutaneous apomorphine Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A","Apomorphine Hydrochloride|APO-goÂ®","APL-130277|subcutaneous apomorphine","\n\n 1.  The subject (and caregiver, if applicable) must be fully informed of and understand the objectives, procedures, and possible benefits and risks of the study, and give written informed consent prior to performing any study related activities.\n 2.  Male or female â‰¥ 18 years of age.\n 3.  Clinical diagnosis of Idiopathic PD, consistent with UK Brain Bank Criteria (excluding the \"more than one affected relative\" criterion).\n 4.  Clinically meaningful response to levodopa (L-Dopa), as determined by the Investigator.\n 5.  Subjects at screening must demonstrate an adequate L-Dopa response on the MDS UPDRS Part III in the \"ON\" state compared to the MDS UPDRS Part III in the \"OFF\" state and on the Hoehn and Yahr, as determined during the review by Enrollment Adjudication Committee (EAC), Sponsor, and Medical Monitor.\n 6.  Receiving stable doses of L Dopa/carbidopa and/or L Dopa/benserazide and/or L Dopa/carbidopa/entacapone (immediate or chronic release) administered at least 4 times per day OR Rytaryâ„¢ administered at least 3 times per day for at least 4 weeks before the initial screening Visit (SV1). Adjunctive PD medication regimens are permitted but must be maintained at a stable dose for at least 4 weeks prior to SV1 with the exception of monoamine oxidase B (MAO B) inhibitors, which must be maintained at a stable level for at least 8 weeks prior to SV1.\n 7.  No planned medication change(s) or surgical intervention anticipated during the course of study.\n 8.  Subjects must experience at least one well defined \"OFF\" episode per day and have a total daily \"OFF\" time duration of > 2 hours during the waking day, based on judgment of physician and subject self assessment.\n 9.  Subject must have predictable morning \"OFF\" periods, based on judgment of physician and subject self assessment.\n 10. Subject, and where appropriate caregiver, must be trained in completing the home dosing diaries and able to recognize \"ON\" and \"OFF\" states.\n 11. Stage III or less on the modified Hoehn and Yahr scale in the \"ON\" state.\n 12. Mini-Mental State Examination (MMSE) score > 25.\n 13. Female subject of childbearing potential and male subject with female partner of childbearing potential must agree to either remain abstinent or use adequate and reliable contraception throughout the study and for at least 7 days after the last dose of study drug has been taken. Note: Continued use of adequate and reliable contraception is recommended through 30 days after study completion.\n 14. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study related procedures to complete the study.\n 15. Must be approved as a satisfactory candidate by the Enrollment Adjudication Committee (EAC), Medical Monitor, and Sponsor.\n\n","\n\n 1.  Atypical or secondary parkinsonism.\n 2.  Major focal brain disorders including malignancy or stroke.\n 3.  Prior treatment with any of the following: a neurosurgical procedure for PD; continuous subcutaneous (subcutaneous) apomorphine infusion; subcutaneous (subcutaneous) apomorphine injection; Duodopa/Duopa; or APL-130277.\n 4.  Contraindications to domperidone, subcutaneous apomorphine, or hypersensitivity to apomorphine hydrochloride or any of the ingredients of subcutaneous apomorphine (notably sodium metabisulfite).\n 5.  Female who is pregnant or lactating.\n 6.  Participation in an interventional clinical study and/or receipt of any investigational (ie, unapproved) medication within 30 days prior to SV1.\n 7.  Currently taking selective 5HT3 antagonists (ie, ondansetron, granisetron, dolasetron, palonosetron, alosetron), dopamine antagonists (excluding quetiapine or clozapine) or dopamine depleting agents. Subjects receiving anti depressants must be on a stable daily dose for at least 8 weeks prior to SV1.\n 8.  The subject has a current diagnosis or history of substance abuse (excluding nicotine and caffeine) or alcohol abuse (in the opinion of the investigator) < 6 months prior to SV1.\n 9.  The recreational use of cannabinoids and hallucinogenic are excluded, as well any use of a sublingual formulation of any drug.\n 10. Subject has a history of malignancy within 5 years prior to SV1, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.\n 11. Subject has a clinically significant abnormality on screening evaluation including physical examination, vital signs, electrocardiogram (ECG), or laboratory tests that the Investigator considers to be inappropriate to allow participation in the study.\n 12. Subject has screening laboratory test results of: blood urea nitrogen (BUN) value â‰¥ 1.5 times the upper limit of normal (ULN) for the reference range; serum creatinine > 1.5 times the ULN for the reference range; or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value â‰¥ 2 times the ULN for the reference laboratory.\n 13. Subject has random (non-fasting) screening glucose of â‰¥ 200 mg/dL (11.1 mmol/L) or HbA1c > 7.0%.\n 14. Subjects with type 1 diabetes, or insulin dependent diabetics are excluded. Subjects with type 2 diabetes are eligible for study inclusion if the following conditions are met: * Subject's screening glucose is < 200 mg/dL (11.1 mmol/L). Note: Subjects with random (non fasting) blood glucose at screening â‰¥ 200 mg/dL (11.1 mmol/L) must be retested in a fasted state; and\n      * Subject's hemoglobin A1c (HbA1c) â‰¤ 7.0%; and\n      * If the subject is currently being treated with oral anti-diabetic medication(s), the dose must have been stable for at least 4 weeks prior to SV1. Such medication may be adjusted or discontinued during the study, as clinically indicated.\n     \n     \n 15. The subject's screening ECG results of corrected QT interval using Fridericia's formula (QTcF) â‰¥ 450 msec for male subjects or â‰¥ 470 msec for female subjects. Eligibility will be based on the core laboratory ECG interpretation report.\n 16. Subject has a positive screening laboratory test result for human immunodeficiency virus (HIV).\n 17. Subject has a positive screening laboratory test result for hepatitis B surface antigen or hepatitis C antibodies and has liver function test results at screening above the ULN for the reference laboratory.\n 18. Subject has any other medical disorder that, in the opinion of the Investigator, could interfere with the subject's participation in the study.\n 19. Subject has major psychiatric disorder(s), including but not limited to: bipolar disorder, psychosis (eg, Parkinson's Disease Psychosis), major depressive episode, or any disorder that, in the opinion of the Investigator, would require treatment that could make study participation unsafe or make treatment compliance difficult.\n 20. History of clinically significant impulse control disorder(s).\n 21. History of symptomatic orthostatic hypotension requiring medication.\n 22. History of severe dyskinesia based on a score of 4 on the MDS-UPDRS Part IV.\n 23. Dementia that precludes providing informed consent or would interfere with participation in the study.\n 24. Current/recent suicidal ideation as evidenced by answering \"yes\" to \"Suicidal Ideation\" item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) on the C-SSRS assessment at screening (using the \"screening /Baseline Version\" scale, in the past 12 months) or attempted suicide within the last 5 years.\n 25. Presence of canker or mouth sores in the 30 days prior to SV1, or other clinically significant oral pathology in the opinion of the Investigator. The Investigator should follow-up with an appropriate specialist on any finding, if indicated, before enrolling a subject into the study","MAOB","monoamine oxidase B","Gene","Prostate","Actual","2018-01-05","Actual","Anticipated","2020-03-24","Anticipated","2019-11-01","2018-01-02","2018-01-02","2019-11-20","No","Parkinson's Disease\n\"Off\" Episodes\nmotor fluctuations associated with Parkinson's Disease","Interventional","Treatment","Crossover Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No","Yes\nIPD for this study may be made available upon request via the Clinical Study Data Request site.",{"$nulls":3},"Yes","No",{"$nulls":4},"Yes",{"$nulls":12},"2016-003456-70","EudraCT Number","change from pre-dose to 90 minutes post-dose in MDS UPDRS Part III score after 4 weeks of dosing in each crossover period (assessed by the blinded-rater in-clinic at Visit 3 and Visit 6 of PART B).","Week 4",null,"Durability of effect, defined as an Investigator confirmed full \"ON\" within 30 minutes post dose and at 90 minutes post-dose, after 4 weeks of dosing in each crossover period (assessed by the blinded-rater in-clinic at Visit 3 and Visit 6 of PART B).|Subject preference for treatment regimen as measured by the Subject Preference Visual Analog Scale (VAS) after the subject has completed both APL 130277 and sc apomorphine treatment regimens (assessed in-clinic at Visit 6 of PART B).|Per the Expanded Home Dosing Diary, percent of \"ON\" episodes without troublesome dyskinesia based on the 3 consecutive days prior to Visit 2, Visit 3, Visit 5, and Visit 6.|Subject confirmed durability of effect, defined as subject confirmed full \"ON\" within 30 minutes post-dose and at 90 minutes post-dose, after 4 weeks of dosing in each crossover period (assessed in-clinic at Visit 3 and Visit 6 of PART B).|Patient Global Impression of Change (PGI-C): Subject improvement of \"OFF\" episodes, defined as very much better, much better or a little better after 4 weeks of dosing in each crossover period (assessed in-clinic at Visit 3 and Visit 6 of PART B).","Week 4|with a recorded range of -50 to 50. Negative values indicate preference for SC treatment, and the more negative the value, the stronger is the preference for SC compared to APL treatment. Positive values indicate preference for APL treatment, and the more positive the value, the stronger is the preference for APL compared to SC treatment. A value of 0 indicates no preference of one treatment over the other.","Week 4","clinicaltrialdisclosure@sunovion.com","CNS Medical Director","1-866-503-6351","Innsbruck, Austria, A-6020|Marseille, France, 13385|Beelitz-Heilstatten, Germany, 14547|Cassino, Italy, 03043|Barcelona, Spain, 08036|London, United Kingdom, Se5 9Rs",null,"Austria|France|Germany|Italy|Spain|United Kingdom","Medical University Innsbruck, Neurolgy Dept|Hopital La Timone, Neurologie Et Pathologie Due Mouvement|Klinken Beelitz Gmbh Neurologisches Fachkrankenhaus Fur Bewegungsstorungen/Parkinson|San Raffaele Cassino|Hospital Clinic De Barcelona|King's College Hospital Nhs Foundation Trust",{"$nulls":3},"CNS Medical Director","2019-11-20","2020-05-25T16:35:27.507","2020-05-26T17:10:42.972","NCT03391882"]
["5ecbf3cf11702c1b1b9169d3","NCT03391882","2019-12-03","Sunovion","SEPR","Recruiting","A Study of an Investigational Drug to See How it Affects the People With Parkinson's Disease Complicated by Motor Fluctuations (\"OFF\" Episodes) Compared to an Approved Drug Used to Treat People With Parkinson's Disease Complicated by Motor Fluctuations (\"OFF\" Episodes)","Apomorphine","DS Agonist","No",null,"No",null,"Phase 3",2,106,"Anticipated","2018-12-19","2020-10-15",{"$nulls":5},"A study of an investigational drug to see how it affects the people with Parkinson's Disease complicated by motor fluctuations (\"OFF\" Episodes) compared to an approved drug used to treat people with Parkinson's Disease complicated by motor fluctuations (\"OFF\" Episodes)","An Open-Label, Randomized, Crossover Trial utilizing a Single-Blinded Rater to evaluate APL-130277 compared to s.c. Apomorphine in Levodopa Responsive Subjects with Parkinson's Disease Complicated by Motor Fluctuations.\n\nPART A consists of an open label, crossover titration phase where eligible subjects will be randomized to 1 of 2 treatment sequences in a 1:1 ratio to Sublingual APL 130277 followed by subcutaneous apomorphine or subcutaneous apomorphine followed by sublingual APL 130277. Subjects will undergo dose titration with the first study treatment (APL 130277 or sc apomorphine) to tolerance and effect, ie, the tolerable dose that turns the subject from the practically defined \"OFF\" state to the full \"ON\" state as determined by both the Investigator and subject. The subject will then be crossed over to the other study treatment (APL 130277 or subcutaneous apomorphine) and similarly titrated to tolerance and effect. These determined doses of APL 130277 and subcutaneous apomorphine will be used during PART B.\n\nPART B consists of an open-label, crossover treatment period where subjects will be randomized to one of the study treatment for 4 weeks, then be crossed over to the other study treatment (APL-130277 or sc apomorphine) for additional 4-weeks of open-label treatment. Subjects return to the clinic for safety and efficacy assessments throughout the treatment period.\n\nThis study is designed to test the superiority of sublingually administered APL-130277 against subcutaneously injected apomorphine (APO-go) for the treatment of \"OFF\" episodes in patients with Parkinson's Disease, as measured by the change from pre-dose to 90 minutes post-dose in MDS UPDRS Part III score in Part B after 4 weeks of dosing in each crossover period.","An Open-Label, Randomized, Crossover Trial Utilizing a Single-Blinded Rater to Evaluate APL-130277 Compared to Subcutaneous Apomorphine in Levodopa Responsive Subjects With Parkinson's Disease Complicated by Motor Fluctuations","CTH-302","Motor OFF Episodes Associated With Parkinson's Disease","Parkinson Disease","Central Nervous System Diseases","Central Nervous System","Experimental|Active Comparator","APL-130277|subcutaneous apomorphine","APL-130277: Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A|subcutaneous apomorphine , Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A","Drug","APL-130277|subcutaneous apomorphine","APL-130277: Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A|subcutaneous apomorphine Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A","Apomorphine Hydrochloride|APO-goÂ®","APL-130277|subcutaneous apomorphine","\n\n 1.  The subject (and caregiver, if applicable) must be fully informed of and understand the objectives, procedures, and possible benefits and risks of the study, and give written informed consent prior to performing any study related activities.\n 2.  Male or female â‰¥ 18 years of age.\n 3.  Clinical diagnosis of Idiopathic PD, consistent with UK Brain Bank Criteria (excluding the \"more than one affected relative\" criterion).\n 4.  Clinically meaningful response to levodopa (L-Dopa), as determined by the Investigator.\n 5.  Subjects at screening must demonstrate an adequate L-Dopa response on the MDS UPDRS Part III in the \"ON\" state compared to the MDS UPDRS Part III in the \"OFF\" state and on the Hoehn and Yahr, as determined during the review by Enrollment Adjudication Committee (EAC), Sponsor, and Medical Monitor.\n 6.  Receiving stable doses of L Dopa/carbidopa and/or L Dopa/benserazide and/or L Dopa/carbidopa/entacapone (immediate or chronic release) administered at least 4 times per day OR Rytaryâ„¢ administered at least 3 times per day for at least 4 weeks before the initial screening Visit (SV1). Adjunctive PD medication regimens are permitted but must be maintained at a stable dose for at least 4 weeks prior to SV1 with the exception of monoamine oxidase B (MAO B) inhibitors, which must be maintained at a stable level for at least 8 weeks prior to SV1.\n 7.  No planned medication change(s) or surgical intervention anticipated during the course of study.\n 8.  Subjects must experience at least one well defined \"OFF\" episode per day and have a total daily \"OFF\" time duration of > 2 hours during the waking day, based on judgment of physician and subject self assessment.\n 9.  Subject must have predictable morning \"OFF\" periods, based on judgment of physician and subject self assessment.\n 10. Subject, and where appropriate caregiver, must be trained in completing the home dosing diaries and able to recognize \"ON\" and \"OFF\" states.\n 11. Stage III or less on the modified Hoehn and Yahr scale in the \"ON\" state.\n 12. Mini-Mental State Examination (MMSE) score > 25.\n 13. Female subject of childbearing potential and male subject with female partner of childbearing potential must agree to either remain abstinent or use adequate and reliable contraception throughout the study and for at least 7 days after the last dose of study drug has been taken. Note: Continued use of adequate and reliable contraception is recommended through 30 days after study completion.\n 14. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study related procedures to complete the study.\n 15. Must be approved as a satisfactory candidate by the Enrollment Adjudication Committee (EAC), Medical Monitor, and Sponsor.\n\n","\n\n 1.  Atypical or secondary parkinsonism.\n 2.  Major focal brain disorders including malignancy or stroke.\n 3.  Prior treatment with any of the following: a neurosurgical procedure for PD; continuous subcutaneous (subcutaneous) apomorphine infusion; subcutaneous (subcutaneous) apomorphine injection; Duodopa/Duopa; or APL-130277.\n 4.  Contraindications to domperidone, subcutaneous apomorphine, or hypersensitivity to apomorphine hydrochloride or any of the ingredients of subcutaneous apomorphine (notably sodium metabisulfite).\n 5.  Female who is pregnant or lactating.\n 6.  Participation in an interventional clinical study and/or receipt of any investigational (ie, unapproved) medication within 30 days prior to SV1.\n 7.  Currently taking selective 5HT3 antagonists (ie, ondansetron, granisetron, dolasetron, palonosetron, alosetron), dopamine antagonists (excluding quetiapine or clozapine) or dopamine depleting agents. Subjects receiving anti depressants must be on a stable daily dose for at least 8 weeks prior to SV1.\n 8.  The subject has a current diagnosis or history of substance abuse (excluding nicotine and caffeine) or alcohol abuse (in the opinion of the investigator) < 6 months prior to SV1.\n 9.  The recreational use of cannabinoids and hallucinogenic are excluded, as well any use of a sublingual formulation of any drug.\n 10. Subject has a history of malignancy within 5 years prior to SV1, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.\n 11. Subject has a clinically significant abnormality on screening evaluation including physical examination, vital signs, electrocardiogram (ECG), or laboratory tests that the Investigator considers to be inappropriate to allow participation in the study.\n 12. Subject has screening laboratory test results of: blood urea nitrogen (BUN) value â‰¥ 1.5 times the upper limit of normal (ULN) for the reference range; serum creatinine > 1.5 times the ULN for the reference range; or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value â‰¥ 2 times the ULN for the reference laboratory.\n 13. Subject has random (non-fasting) screening glucose of â‰¥ 200 mg/dL (11.1 mmol/L) or HbA1c > 7.0%.\n 14. Subjects with type 1 diabetes, or insulin dependent diabetics are excluded. Subjects with type 2 diabetes are eligible for study inclusion if the following conditions are met: * Subject's screening glucose is < 200 mg/dL (11.1 mmol/L). Note: Subjects with random (non fasting) blood glucose at screening â‰¥ 200 mg/dL (11.1 mmol/L) must be retested in a fasted state; and\n      * Subject's hemoglobin A1c (HbA1c) â‰¤ 7.0%; and\n      * If the subject is currently being treated with oral anti-diabetic medication(s), the dose must have been stable for at least 4 weeks prior to SV1. Such medication may be adjusted or discontinued during the study, as clinically indicated.\n     \n     \n 15. The subject's screening ECG results of corrected QT interval using Fridericia's formula (QTcF) â‰¥ 450 msec for male subjects or â‰¥ 470 msec for female subjects. Eligibility will be based on the core laboratory ECG interpretation report.\n 16. Subject has a positive screening laboratory test result for human immunodeficiency virus (HIV).\n 17. Subject has a positive screening laboratory test result for hepatitis B surface antigen or hepatitis C antibodies and has liver function test results at screening above the ULN for the reference laboratory.\n 18. Subject has any other medical disorder that, in the opinion of the Investigator, could interfere with the subject's participation in the study.\n 19. Subject has major psychiatric disorder(s), including but not limited to: bipolar disorder, psychosis (eg, Parkinson's Disease Psychosis), major depressive episode, or any disorder that, in the opinion of the Investigator, would require treatment that could make study participation unsafe or make treatment compliance difficult.\n 20. History of clinically significant impulse control disorder(s).\n 21. History of symptomatic orthostatic hypotension requiring medication.\n 22. History of severe dyskinesia based on a score of 4 on the MDS-UPDRS Part IV.\n 23. Dementia that precludes providing informed consent or would interfere with participation in the study.\n 24. Current/recent suicidal ideation as evidenced by answering \"yes\" to \"Suicidal Ideation\" item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) on the C-SSRS assessment at screening (using the \"screening /Baseline Version\" scale, in the past 12 months) or attempted suicide within the last 5 years.\n 25. Presence of canker or mouth sores in the 30 days prior to SV1, or other clinically significant oral pathology in the opinion of the Investigator. The Investigator should follow-up with an appropriate specialist on any finding, if indicated, before enrolling a subject into the study","MAOB","monoamine oxidase B","Gene","Prostate","Actual","2018-01-05","Actual","Anticipated","2020-10-15","Anticipated","2019-12-01","2018-01-02","2018-01-02","2019-12-02","No","Parkinson's Disease\n\"Off\" Episodes\nmotor fluctuations associated with Parkinson's Disease","Interventional","Treatment","Crossover Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No","Yes\nIPD for this study may be made available upon request via the Clinical Study Data Request site.",{"$nulls":3},"Yes","No",{"$nulls":4},"Yes",{"$nulls":12},"2016-003456-70","EudraCT Number","change from pre-dose to 90 minutes post-dose in MDS UPDRS Part III score after 4 weeks of dosing in each crossover period (assessed by the blinded-rater in-clinic at Visit 3 and Visit 6 of PART B).","Week 4",null,"Durability of effect, defined as an Investigator confirmed full \"ON\" within 30 minutes post dose and at 90 minutes post-dose, after 4 weeks of dosing in each crossover period (assessed by the blinded-rater in-clinic at Visit 3 and Visit 6 of PART B).|Subject preference for treatment regimen as measured by the Subject Preference Visual Analog Scale (VAS) after the subject has completed both APL 130277 and sc apomorphine treatment regimens (assessed in-clinic at Visit 6 of PART B).|Per the Expanded Home Dosing Diary, percent of \"ON\" episodes without troublesome dyskinesia based on the 3 consecutive days prior to Visit 2, Visit 3, Visit 5, and Visit 6.|Subject confirmed durability of effect, defined as subject confirmed full \"ON\" within 30 minutes post-dose and at 90 minutes post-dose, after 4 weeks of dosing in each crossover period (assessed in-clinic at Visit 3 and Visit 6 of PART B).|Patient Global Impression of Change (PGI-C): Subject improvement of \"OFF\" episodes, defined as very much better, much better or a little better after 4 weeks of dosing in each crossover period (assessed in-clinic at Visit 3 and Visit 6 of PART B).","Week 4|with a recorded range of -50 to 50. Negative values indicate preference for SC treatment, and the more negative the value, the stronger is the preference for SC compared to APL treatment. Positive values indicate preference for APL treatment, and the more positive the value, the stronger is the preference for APL compared to SC treatment. A value of 0 indicates no preference of one treatment over the other.","Week 4","clinicaltrialdisclosure@sunovion.com","CNS Medical Director","1-866-503-6351","Innsbruck, Austria, A-6020|Marseille, France, 13385|Beelitz-Heilstatten, Germany, 14547|Cassino, Italy, 03043|Barcelona, Spain, 08036|London, United Kingdom, Se5 9Rs",null,"Austria|France|Germany|Italy|Spain|United Kingdom","Medical University Innsbruck, Neurolgy Dept|Hopital La Timone, Neurologie Et Pathologie Due Mouvement|Klinken Beelitz Gmbh Neurologisches Fachkrankenhaus Fur Bewegungsstorungen/Parkinson|San Raffaele Cassino|Hospital Clinic De Barcelona|King's College Hospital Nhs Foundation Trust",{"$nulls":3},"CNS Medical Director","2019-12-02","2020-05-25T16:35:27.869","2020-05-26T17:10:42.972","NCT03391882"]
["5ecbf3d011702c1b1b9169d4","NCT03391882","2020-02-25","Sunovion","SEPR","Recruiting","A Study of an Investigational Drug to See How it Affects the People With Parkinson's Disease Complicated by Motor Fluctuations (\"OFF\" Episodes) Compared to an Approved Drug Used to Treat People With Parkinson's Disease Complicated by Motor Fluctuations (\"OFF\" Episodes)","Apomorphine","DS Agonist","No",null,"No",null,"Phase 3",2,106,"Anticipated","2018-12-19","2020-10-15",{"$nulls":5},"A study of an investigational drug to see how it affects the people with Parkinson's Disease complicated by motor fluctuations (\"OFF\" Episodes) compared to an approved drug used to treat people with Parkinson's Disease complicated by motor fluctuations (\"OFF\" Episodes)","An Open-Label, Randomized, Crossover Trial utilizing a Single-Blinded Rater to evaluate APL-130277 compared to s.c. Apomorphine in Levodopa Responsive Subjects with Parkinson's Disease Complicated by Motor Fluctuations.\n\nPART A consists of an open label, crossover titration phase where eligible subjects will be randomized to 1 of 2 treatment sequences in a 1:1 ratio to Sublingual APL 130277 followed by subcutaneous apomorphine or subcutaneous apomorphine followed by sublingual APL 130277. Subjects will undergo dose titration with the first study treatment (APL 130277 or sc apomorphine) to tolerance and effect, ie, the tolerable dose that turns the subject from the practically defined \"OFF\" state to the full \"ON\" state as determined by both the Investigator and subject. The subject will then be crossed over to the other study treatment (APL 130277 or subcutaneous apomorphine) and similarly titrated to tolerance and effect. These determined doses of APL 130277 and subcutaneous apomorphine will be used during PART B.\n\nPART B consists of an open-label, crossover treatment period where subjects will be randomized to one of the study treatment for 4 weeks, then be crossed over to the other study treatment (APL-130277 or sc apomorphine) for additional 4-weeks of open-label treatment. Subjects return to the clinic for safety and efficacy assessments throughout the treatment period.\n\nThis study is designed to test the superiority of sublingually administered APL-130277 against subcutaneously injected apomorphine (APO-go) for the treatment of \"OFF\" episodes in patients with Parkinson's Disease, as measured by the change from pre-dose to 90 minutes post-dose in MDS UPDRS Part III score in Part B after 4 weeks of dosing in each crossover period.","An Open-Label, Randomized, Crossover Trial Utilizing a Single-Blinded Rater to Evaluate APL-130277 Compared to Subcutaneous Apomorphine in Levodopa Responsive Subjects With Parkinson's Disease Complicated by Motor Fluctuations","CTH-302","Motor OFF Episodes Associated With Parkinson's Disease","Parkinson Disease","Central Nervous System Diseases","Central Nervous System","Experimental|Active Comparator","APL-130277|subcutaneous apomorphine","APL-130277: Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A|subcutaneous apomorphine , Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A","Drug","APL-130277|subcutaneous apomorphine","APL-130277: Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A|subcutaneous apomorphine Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A","Apomorphine Hydrochloride|APO-goÂ®","APL-130277|subcutaneous apomorphine","\n\n 1.  The subject (and caregiver, if applicable) must be fully informed of and understand the objectives, procedures, and possible benefits and risks of the study, and give written informed consent prior to performing any study related activities.\n 2.  Male or female â‰¥ 18 years of age.\n 3.  Clinical diagnosis of Idiopathic PD, consistent with UK Brain Bank Criteria (excluding the \"more than one affected relative\" criterion).\n 4.  Clinically meaningful response to levodopa (L-Dopa), as determined by the Investigator.\n 5.  Subjects at screening must demonstrate an adequate L-Dopa response on the MDS UPDRS Part III in the \"ON\" state compared to the MDS UPDRS Part III in the \"OFF\" state and on the Hoehn and Yahr, as determined during the review by Enrollment Adjudication Committee (EAC), Sponsor, and Medical Monitor.\n 6.  Receiving stable doses of L Dopa/carbidopa and/or L Dopa/benserazide and/or L Dopa/carbidopa/entacapone (immediate or chronic release) administered at least 4 times per day OR Rytaryâ„¢ administered at least 3 times per day for at least 4 weeks before the initial screening Visit (SV1). Adjunctive PD medication regimens are permitted but must be maintained at a stable dose for at least 4 weeks prior to SV1 with the exception of monoamine oxidase B (MAO B) inhibitors, which must be maintained at a stable level for at least 8 weeks prior to SV1.\n 7.  No planned medication change(s) or surgical intervention anticipated during the course of study.\n 8.  Subjects must experience at least one well defined \"OFF\" episode per day and have a total daily \"OFF\" time duration of > 2 hours during the waking day, based on judgment of physician and subject self assessment.\n 9.  Subject must have predictable morning \"OFF\" periods, based on judgment of physician and subject self assessment.\n 10. Subject, and where appropriate caregiver, must be trained in completing the home dosing diaries and able to recognize \"ON\" and \"OFF\" states.\n 11. Stage III or less on the modified Hoehn and Yahr scale in the \"ON\" state.\n 12. Mini-Mental State Examination (MMSE) score > 25.\n 13. Female subject of childbearing potential and male subject with female partner of childbearing potential must agree to either remain abstinent or use adequate and reliable contraception throughout the study and for at least 7 days after the last dose of study drug has been taken. Note: Continued use of adequate and reliable contraception is recommended through 30 days after study completion.\n 14. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study related procedures to complete the study.\n 15. Must be approved as a satisfactory candidate by the Enrollment Adjudication Committee (EAC), Medical Monitor, and Sponsor.\n\n","\n\n 1.  Atypical or secondary parkinsonism.\n 2.  Major focal brain disorders including malignancy or stroke.\n 3.  Prior treatment with any of the following: a neurosurgical procedure for PD; continuous subcutaneous (subcutaneous) apomorphine infusion; subcutaneous (subcutaneous) apomorphine injection; Duodopa/Duopa; or APL-130277.\n 4.  Contraindications to domperidone, subcutaneous apomorphine, or hypersensitivity to apomorphine hydrochloride or any of the ingredients of subcutaneous apomorphine (notably sodium metabisulfite).\n 5.  Female who is pregnant or lactating.\n 6.  Participation in an interventional clinical study and/or receipt of any investigational (ie, unapproved) medication within 30 days prior to SV1.\n 7.  Currently taking selective 5HT3 antagonists (ie, ondansetron, granisetron, dolasetron, palonosetron, alosetron), dopamine antagonists (excluding quetiapine or clozapine) or dopamine depleting agents. Subjects receiving anti depressants must be on a stable daily dose for at least 8 weeks prior to SV1.\n 8.  The subject has a current diagnosis or history of substance abuse (excluding nicotine and caffeine) or alcohol abuse (in the opinion of the investigator) < 6 months prior to SV1.\n 9.  The recreational use of cannabinoids and hallucinogenic are excluded, as well any use of a sublingual formulation of any drug.\n 10. Subject has a history of malignancy within 5 years prior to SV1, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.\n 11. Subject has a clinically significant abnormality on screening evaluation including physical examination, vital signs, electrocardiogram (ECG), or laboratory tests that the Investigator considers to be inappropriate to allow participation in the study.\n 12. Subject has screening laboratory test results of: blood urea nitrogen (BUN) value â‰¥ 1.5 times the upper limit of normal (ULN) for the reference range; serum creatinine > 1.5 times the ULN for the reference range; or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value â‰¥ 2 times the ULN for the reference laboratory.\n 13. Subject has random (non-fasting) screening glucose of â‰¥ 200 mg/dL (11.1 mmol/L) or HbA1c > 7.0%.\n 14. Subjects with type 1 diabetes, or insulin dependent diabetics are excluded. Subjects with type 2 diabetes are eligible for study inclusion if the following conditions are met: * Subject's screening glucose is < 200 mg/dL (11.1 mmol/L). Note: Subjects with random (non fasting) blood glucose at screening â‰¥ 200 mg/dL (11.1 mmol/L) must be retested in a fasted state; and\n      * Subject's hemoglobin A1c (HbA1c) â‰¤ 7.0%; and\n      * If the subject is currently being treated with oral anti-diabetic medication(s), the dose must have been stable for at least 4 weeks prior to SV1. Such medication may be adjusted or discontinued during the study, as clinically indicated.\n     \n     \n 15. The subject's screening ECG results of corrected QT interval using Fridericia's formula (QTcF) â‰¥ 450 msec for male subjects or â‰¥ 470 msec for female subjects. Eligibility will be based on the core laboratory ECG interpretation report.\n 16. Subject has a positive screening laboratory test result for human immunodeficiency virus (HIV).\n 17. Subject has a positive screening laboratory test result for hepatitis B surface antigen or hepatitis C antibodies and has liver function test results at screening above the ULN for the reference laboratory.\n 18. Subject has any other medical disorder that, in the opinion of the Investigator, could interfere with the subject's participation in the study.\n 19. Subject has major psychiatric disorder(s), including but not limited to: bipolar disorder, psychosis (eg, Parkinson's Disease Psychosis), major depressive episode, or any disorder that, in the opinion of the Investigator, would require treatment that could make study participation unsafe or make treatment compliance difficult.\n 20. History of clinically significant impulse control disorder(s).\n 21. History of symptomatic orthostatic hypotension requiring medication.\n 22. History of severe dyskinesia based on a score of 4 on the MDS-UPDRS Part IV.\n 23. Dementia that precludes providing informed consent or would interfere with participation in the study.\n 24. Current/recent suicidal ideation as evidenced by answering \"yes\" to \"Suicidal Ideation\" item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) on the C-SSRS assessment at screening (using the \"screening /Baseline Version\" scale, in the past 12 months) or attempted suicide within the last 5 years.\n 25. Presence of canker or mouth sores in the 30 days prior to SV1, or other clinically significant oral pathology in the opinion of the Investigator. The Investigator should follow-up with an appropriate specialist on any finding, if indicated, before enrolling a subject into the study","MAOB","monoamine oxidase B","Gene","Prostate","Actual","2018-01-05","Actual","Anticipated","2020-10-15","Anticipated","2020-02-01","2018-01-02","2018-01-02","2020-02-24","No","Parkinson's Disease\n\"Off\" Episodes\nmotor fluctuations associated with Parkinson's Disease","Interventional","Treatment","Crossover Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No","Yes\nIPD for this study may be made available upon request via the Clinical Study Data Request site.",{"$nulls":3},"Yes","No",{"$nulls":4},"Yes",{"$nulls":12},"2016-003456-70","EudraCT Number","change from pre-dose to 90 minutes post-dose in MDS UPDRS Part III score after 4 weeks of dosing in each crossover period (assessed by the blinded-rater in-clinic at Visit 3 and Visit 6 of PART B).","Week 4",null,"Durability of effect, defined as an Investigator confirmed full \"ON\" within 30 minutes post dose and at 90 minutes post-dose, after 4 weeks of dosing in each crossover period (assessed by the blinded-rater in-clinic at Visit 3 and Visit 6 of PART B).|Subject preference for treatment regimen as measured by the Subject Preference Visual Analog Scale (VAS) after the subject has completed both APL 130277 and sc apomorphine treatment regimens (assessed in-clinic at Visit 6 of PART B).|Per the Expanded Home Dosing Diary, percent of \"ON\" episodes without troublesome dyskinesia based on the 3 consecutive days prior to Visit 2, Visit 3, Visit 5, and Visit 6.|Subject confirmed durability of effect, defined as subject confirmed full \"ON\" within 30 minutes post-dose and at 90 minutes post-dose, after 4 weeks of dosing in each crossover period (assessed in-clinic at Visit 3 and Visit 6 of PART B).|Patient Global Impression of Change (PGI-C): Subject improvement of \"OFF\" episodes, defined as very much better, much better or a little better after 4 weeks of dosing in each crossover period (assessed in-clinic at Visit 3 and Visit 6 of PART B).","Week 4|with a recorded range of -50 to 50. Negative values indicate preference for SC treatment, and the more negative the value, the stronger is the preference for SC compared to APL treatment. Positive values indicate preference for APL treatment, and the more positive the value, the stronger is the preference for APL compared to SC treatment. A value of 0 indicates no preference of one treatment over the other.","Week 4","clinicaltrialdisclosure@sunovion.com","CNS Medical Director","1-866-503-6351","Innsbruck, Austria, A-6020|Marseille, France, 13385|Beelitz-Heilstatten, Germany, 14547|Cassino, Italy, 03043|Barcelona, Spain, 08036|London, United Kingdom, Se5 9Rs",null,"Austria|France|Germany|Italy|Spain|United Kingdom","Medical University Innsbruck, Neurolgy Dept|Hopital La Timone, Neurologie Et Pathologie Due Mouvement|Klinken Beelitz Gmbh Neurologisches Fachkrankenhaus Fur Bewegungsstorungen/Parkinson|San Raffaele Cassino|Hospital Clinic De Barcelona|King's College Hospital Nhs Foundation Trust",{"$nulls":3},"CNS Medical Director","2020-02-24","2020-05-25T16:35:28.019","2020-05-26T17:10:42.972","NCT03391882"]
["5ecbf3d0e2561b1b11905cbc","NCT03391882","2020-02-28","Sunovion","SEPR","Recruiting","A Study of an Investigational Drug to See How it Affects the People With Parkinson's Disease Complicated by Motor Fluctuations (\"OFF\" Episodes) Compared to an Approved Drug Used to Treat People With Parkinson's Disease Complicated by Motor Fluctuations (\"OFF\" Episodes)","Apomorphine","DS Agonist","No",null,"No",null,"Phase 3",2,106,"Anticipated","2018-12-19","2020-10-15",{"$nulls":5},"A study of an investigational drug to see how it affects the people with Parkinson's Disease complicated by motor fluctuations (\"OFF\" Episodes) compared to an approved drug used to treat people with Parkinson's Disease complicated by motor fluctuations (\"OFF\" Episodes)","An Open-Label, Randomized, Crossover Trial utilizing a Single-Blinded Rater to evaluate APL-130277 compared to s.c. Apomorphine in Levodopa Responsive Subjects with Parkinson's Disease Complicated by Motor Fluctuations.\n\nPART A consists of an open label, crossover titration phase where eligible subjects will be randomized to 1 of 2 treatment sequences in a 1:1 ratio to Sublingual APL 130277 followed by subcutaneous apomorphine or subcutaneous apomorphine followed by sublingual APL 130277. Subjects will undergo dose titration with the first study treatment (APL 130277 or sc apomorphine) to tolerance and effect, ie, the tolerable dose that turns the subject from the practically defined \"OFF\" state to the full \"ON\" state as determined by both the Investigator and subject. The subject will then be crossed over to the other study treatment (APL 130277 or subcutaneous apomorphine) and similarly titrated to tolerance and effect. These determined doses of APL 130277 and subcutaneous apomorphine will be used during PART B.\n\nPART B consists of an open-label, crossover treatment period where subjects will be randomized to one of the study treatment for 4 weeks, then be crossed over to the other study treatment (APL-130277 or sc apomorphine) for additional 4-weeks of open-label treatment. Subjects return to the clinic for safety and efficacy assessments throughout the treatment period.\n\nThis study is designed to test the superiority of sublingually administered APL-130277 against subcutaneously injected apomorphine (APO-go) for the treatment of \"OFF\" episodes in patients with Parkinson's Disease, as measured by the change from pre-dose to 90 minutes post-dose in MDS UPDRS Part III score in Part B after 4 weeks of dosing in each crossover period.","An Open-Label, Randomized, Crossover Trial Utilizing a Single-Blinded Rater to Evaluate APL-130277 Compared to Subcutaneous Apomorphine in Levodopa Responsive Subjects With Parkinson's Disease Complicated by Motor Fluctuations","CTH-302","Motor OFF Episodes Associated With Parkinson's Disease","Parkinson Disease","Central Nervous System Diseases","Central Nervous System","Experimental|Active Comparator","APL-130277|subcutaneous apomorphine","APL-130277: Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A|subcutaneous apomorphine , Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A","Drug","APL-130277|subcutaneous apomorphine","APL-130277: Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A|subcutaneous apomorphine Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A","Apomorphine Hydrochloride|APO-goÂ®","APL-130277|subcutaneous apomorphine","\n\n 1.  The subject (and caregiver, if applicable) must be fully informed of and understand the objectives, procedures, and possible benefits and risks of the study, and give written informed consent prior to performing any study related activities.\n 2.  Male or female â‰¥ 18 years of age.\n 3.  Clinical diagnosis of Idiopathic PD, consistent with UK Brain Bank Criteria (excluding the \"more than one affected relative\" criterion).\n 4.  Clinically meaningful response to levodopa (L-Dopa), as determined by the Investigator.\n 5.  Subjects at screening must demonstrate an adequate L-Dopa response on the MDS UPDRS Part III in the \"ON\" state compared to the MDS UPDRS Part III in the \"OFF\" state and on the Hoehn and Yahr, as determined during the review by Enrollment Adjudication Committee (EAC), Sponsor, and Medical Monitor.\n 6.  Receiving stable doses of L Dopa/carbidopa and/or L Dopa/benserazide and/or L Dopa/carbidopa/entacapone (immediate or chronic release) administered at least 4 times per day OR Rytaryâ„¢ administered at least 3 times per day for at least 4 weeks before the initial screening Visit (SV1). Adjunctive PD medication regimens are permitted but must be maintained at a stable dose for at least 4 weeks prior to SV1 with the exception of monoamine oxidase B (MAO B) inhibitors, which must be maintained at a stable level for at least 8 weeks prior to SV1.\n 7.  No planned medication change(s) or surgical intervention anticipated during the course of study.\n 8.  Subjects must experience at least one well defined \"OFF\" episode per day and have a total daily \"OFF\" time duration of > 2 hours during the waking day, based on judgment of physician and subject self assessment.\n 9.  Subject must have predictable morning \"OFF\" periods, based on judgment of physician and subject self assessment.\n 10. Subject, and where appropriate caregiver, must be trained in completing the home dosing diaries and able to recognize \"ON\" and \"OFF\" states.\n 11. Stage III or less on the modified Hoehn and Yahr scale in the \"ON\" state.\n 12. Mini-Mental State Examination (MMSE) score > 25.\n 13. Female subject of childbearing potential and male subject with female partner of childbearing potential must agree to either remain abstinent or use adequate and reliable contraception throughout the study and for at least 7 days after the last dose of study drug has been taken. Note: Continued use of adequate and reliable contraception is recommended through 30 days after study completion.\n 14. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study related procedures to complete the study.\n 15. Must be approved as a satisfactory candidate by the Enrollment Adjudication Committee (EAC), Medical Monitor, and Sponsor.\n\n","\n\n 1.  Atypical or secondary parkinsonism.\n 2.  Major focal brain disorders including malignancy or stroke.\n 3.  Prior treatment with any of the following: a neurosurgical procedure for PD; continuous subcutaneous (subcutaneous) apomorphine infusion; subcutaneous (subcutaneous) apomorphine injection; Duodopa/Duopa; or APL-130277.\n 4.  Contraindications to domperidone, subcutaneous apomorphine, or hypersensitivity to apomorphine hydrochloride or any of the ingredients of subcutaneous apomorphine (notably sodium metabisulfite).\n 5.  Female who is pregnant or lactating.\n 6.  Participation in an interventional clinical study and/or receipt of any investigational (ie, unapproved) medication within 30 days prior to SV1.\n 7.  Currently taking selective 5HT3 antagonists (ie, ondansetron, granisetron, dolasetron, palonosetron, alosetron), dopamine antagonists (excluding quetiapine or clozapine) or dopamine depleting agents. Subjects receiving anti depressants must be on a stable daily dose for at least 8 weeks prior to SV1.\n 8.  The subject has a current diagnosis or history of substance abuse (excluding nicotine and caffeine) or alcohol abuse (in the opinion of the investigator) < 6 months prior to SV1.\n 9.  The recreational use of cannabinoids and hallucinogenic are excluded, as well any use of a sublingual formulation of any drug.\n 10. Subject has a history of malignancy within 5 years prior to SV1, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.\n 11. Subject has a clinically significant abnormality on screening evaluation including physical examination, vital signs, electrocardiogram (ECG), or laboratory tests that the Investigator considers to be inappropriate to allow participation in the study.\n 12. Subject has screening laboratory test results of: blood urea nitrogen (BUN) value â‰¥ 1.5 times the upper limit of normal (ULN) for the reference range; serum creatinine > 1.5 times the ULN for the reference range; or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value â‰¥ 2 times the ULN for the reference laboratory.\n 13. Subject has random (non-fasting) screening glucose of â‰¥ 200 mg/dL (11.1 mmol/L) or HbA1c > 7.0%.\n 14. Subjects with type 1 diabetes, or insulin dependent diabetics are excluded. Subjects with type 2 diabetes are eligible for study inclusion if the following conditions are met: * Subject's screening glucose is < 200 mg/dL (11.1 mmol/L). Note: Subjects with random (non fasting) blood glucose at screening â‰¥ 200 mg/dL (11.1 mmol/L) must be retested in a fasted state; and\n      * Subject's hemoglobin A1c (HbA1c) â‰¤ 7.0%; and\n      * If the subject is currently being treated with oral anti-diabetic medication(s), the dose must have been stable for at least 4 weeks prior to SV1. Such medication may be adjusted or discontinued during the study, as clinically indicated.\n     \n     \n 15. The subject's screening ECG results of corrected QT interval using Fridericia's formula (QTcF) â‰¥ 450 msec for male subjects or â‰¥ 470 msec for female subjects. Eligibility will be based on the core laboratory ECG interpretation report.\n 16. Subject has a positive screening laboratory test result for human immunodeficiency virus (HIV).\n 17. Subject has a positive screening laboratory test result for hepatitis B surface antigen or hepatitis C antibodies and has liver function test results at screening above the ULN for the reference laboratory.\n 18. Subject has any other medical disorder that, in the opinion of the Investigator, could interfere with the subject's participation in the study.\n 19. Subject has major psychiatric disorder(s), including but not limited to: bipolar disorder, psychosis (eg, Parkinson's Disease Psychosis), major depressive episode, or any disorder that, in the opinion of the Investigator, would require treatment that could make study participation unsafe or make treatment compliance difficult.\n 20. History of clinically significant impulse control disorder(s).\n 21. History of symptomatic orthostatic hypotension requiring medication.\n 22. History of severe dyskinesia based on a score of 4 on the MDS-UPDRS Part IV.\n 23. Dementia that precludes providing informed consent or would interfere with participation in the study.\n 24. Current/recent suicidal ideation as evidenced by answering \"yes\" to \"Suicidal Ideation\" item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) on the C-SSRS assessment at screening (using the \"screening /Baseline Version\" scale, in the past 12 months) or attempted suicide within the last 5 years.\n 25. Presence of canker or mouth sores in the 30 days prior to SV1, or other clinically significant oral pathology in the opinion of the Investigator. The Investigator should follow-up with an appropriate specialist on any finding, if indicated, before enrolling a subject into the study","MAOB","monoamine oxidase B","Gene","Prostate","Actual","2018-01-05","Actual","Anticipated","2020-10-15","Anticipated","2020-02-01","2018-01-02","2018-01-02","2020-02-27","No","Parkinson's Disease\n\"Off\" Episodes\nmotor fluctuations associated with Parkinson's Disease","Interventional","Treatment","Crossover Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No","Yes\nIPD for this study may be made available upon request via the Clinical Study Data Request site.",{"$nulls":3},"Yes","No",{"$nulls":4},"Yes",{"$nulls":12},"2016-003456-70","EudraCT Number","change from pre-dose to 90 minutes post-dose in MDS UPDRS Part III score after 4 weeks of dosing in each crossover period (assessed by the blinded-rater in-clinic at Visit 3 and Visit 6 of PART B).","Week 4",null,"Durability of effect, defined as an Investigator confirmed full \"ON\" within 30 minutes post dose and at 90 minutes post-dose, after 4 weeks of dosing in each crossover period (assessed by the blinded-rater in-clinic at Visit 3 and Visit 6 of PART B).|Subject preference for treatment regimen as measured by the Subject Preference Visual Analog Scale (VAS) after the subject has completed both APL 130277 and sc apomorphine treatment regimens (assessed in-clinic at Visit 6 of PART B).|Per the Expanded Home Dosing Diary, percent of \"ON\" episodes without troublesome dyskinesia based on the 3 consecutive days prior to Visit 2, Visit 3, Visit 5, and Visit 6.|Subject confirmed durability of effect, defined as subject confirmed full \"ON\" within 30 minutes post-dose and at 90 minutes post-dose, after 4 weeks of dosing in each crossover period (assessed in-clinic at Visit 3 and Visit 6 of PART B).|Patient Global Impression of Change (PGI-C): Subject improvement of \"OFF\" episodes, defined as very much better, much better or a little better after 4 weeks of dosing in each crossover period (assessed in-clinic at Visit 3 and Visit 6 of PART B).","Week 4|with a recorded range of -50 to 50. Negative values indicate preference for SC treatment, and the more negative the value, the stronger is the preference for SC compared to APL treatment. Positive values indicate preference for APL treatment, and the more positive the value, the stronger is the preference for APL compared to SC treatment. A value of 0 indicates no preference of one treatment over the other.","Week 4","clinicaltrialdisclosure@sunovion.com","CNS Medical Director","1-866-503-6351","Innsbruck, Austria, A-6020|Marseille, France, 13385|Beelitz-Heilstatten, Germany, 14547|Cassino, Italy, 03043|Barcelona, Spain, 08036|London, United Kingdom, Se5 9Rs",null,"Austria|France|Germany|Italy|Spain|United Kingdom","Medical University Innsbruck, Neurolgy Dept|Hopital La Timone, Neurologie Et Pathologie Due Mouvement|Klinken Beelitz Gmbh Neurologisches Fachkrankenhaus Fur Bewegungsstorungen/Parkinson|San Raffaele Cassino|Hospital Clinic De Barcelona|King's College Hospital Nhs Foundation Trust",{"$nulls":3},"CNS Medical Director","2020-02-27","2020-05-25T16:35:28.095","2020-05-26T17:10:42.972","NCT03391882"]
["5ecbf3d0feab101b155307f1","NCT03392051","2018-01-05","Akcea","AKCA","Recruiting","Drug-drug Interaction Study to Evaluate the Effect of ISIS 681257 on Clopidogrel","Clopidogrel|Isis-681257","P2Y12 Antagonist|GPIIb/IIIa Inhibitor","Yes","['Isis-681257']","No",null,"Phase 1",2,18,"Anticipated","2017-12-28","2018-03-01",{"$nulls":5},"This is a single center, open label, single sequence, two treatment, two-period drug-drug interaction study to evaluate the effect of multiple doses of ISIS 681257 on the pharmacokinetics of multiple doses of clopidogrel",null,"Drug-Drug Interaction Study To Evaluate The Effect Of Multiple Doses Of ISIS 681257 40 mg Subcutaneous Injections On The Pharmacokinetics And Pharmacodynamics Of Clopidogrel In Healthy Subjects","ISIS 681257-CS11","Elevated Lipoprotein(a)\nCardiovascular Diseases","Healthy Volunteers","Healthy","Healthy","Experimental","Clopidogrel Dosing|Clopidogrel in combination with ISIS 681257","Multiple doses of Clopidogrel to obtain pharmacokinetic information.|Multiple doses of clopidogrel administered with 2 doses of ISIS 681257 at 2 individual timepoints to obtain pharmacokinetic information.","Drug","Clopidogrel|ISIS 681257","75mg tablet administered orally|Xmg dose administered as a subcutaneous injection",null,"Clopidogrel Dosing|Clopidogrel in combination with ISIS 681257","\n\n * Motivated and available for duration of study and willing to adhere to protocol\n * Males who are unable to procreate or agree to contraception throughout study\n * Females who are postmenopausal or surgically sterile\n * BMI between 18.5 and 30 kg/m2\n * Weighing greater than or equal to 50kg\n * Normal lab results\n * No known diseases or significant findings on physical exam\n\n","\n\n * Females of childbearing potential\n * Reactions/infection at injection site\n * Hypersensitivity to any drugs or similar drugs to those used in the study\n * Conditions or disease that may interfere with study drug\n * Any significant diseases\n * Known history or familial history of bleeding disorders\n * Drug dependency or abuse\n * Illness within 28 days\n * Previous exposure to other investigational drug within 28 days\n * Blood donations within 28 days",{"$nulls":4},"Actual","2018-01-05","Actual","Anticipated","2018-03-01","Anticipated","2018-01-01","2018-01-02","2018-01-02","2018-01-02",null,null,"Interventional","Other","Sequential Assignment","None (Open Label)","Non-Randomized","18 Years","60 Years","All",null,"Yes","No",{"$nulls":3},"No","No",{"$nulls":19},"Evaluate the effect of multiple doses (2 doses) of ISIS 681257 40 mg subcutaneous injections on the PK of multiple oral doses of clopidogrel in healthy adult subjects","The plasma concentrations of Clopidogrel and ISIS 681257 will be measured at each individual time point.","55 days","Evaluate the safety of multiple doses (2 doses) of ISIS 681257 40 mg subcutaneous injections when co-administered with multiple oral doses of clopidogrel in healthy adult subjects|Evaluate the effect of multiple doses (2 doses) of ISIS 681257 40 mg subcutaneous injections on the pharmacodynamics (antiplatelet activity) of multiple doses of clopidogrel in healthy adult subjects","Safety will be assessed by summarizing the reported adverse events|P2Y12 reaction units (PRUs) will be measured at each individual time point.","55 days","clinicalstudies@akceatx.com","Akcea Therapeutics","617-207-0297","Mount Royal, Quebec, Canada, H3P 3H5",null,"Canada","Quebec Clinical Site",{"$nulls":4},"2018-01-02","2020-05-25T16:35:28.430","2020-05-26T17:10:42.972","NCT03392051"]
["5ecbf3d0fe30261b1a0481c3","NCT03392051","2018-02-20","Akcea","AKCA","Active, not recruiting","Drug-drug Interaction Study to Evaluate the Effect of ISIS 681257 on Clopidogrel","Clopidogrel|Isis-681257","P2Y12 Antagonist|GPIIb/IIIa Inhibitor","Yes","['Isis-681257']","No",null,"Phase 1",2,18,"Actual","2017-12-28","2018-03-01",{"$nulls":5},"This is a single center, open label, single sequence, two treatment, two-period drug-drug interaction study to evaluate the effect of multiple doses of ISIS 681257 on the pharmacokinetics of multiple doses of clopidogrel",null,"Drug-Drug Interaction Study To Evaluate The Effect Of Multiple Doses Of ISIS 681257 40 mg Subcutaneous Injections On The Pharmacokinetics And Pharmacodynamics Of Clopidogrel In Healthy Subjects","ISIS 681257-CS11","Elevated Lipoprotein(a)\nCardiovascular Diseases","Healthy Volunteers","Healthy","Healthy","Experimental","Clopidogrel Dosing|Clopidogrel in combination with ISIS 681257","Multiple doses of Clopidogrel to obtain pharmacokinetic information.|Multiple doses of clopidogrel administered with 2 doses of ISIS 681257 at 2 individual timepoints to obtain pharmacokinetic information.","Drug","Clopidogrel|ISIS 681257","75mg tablet administered orally|Xmg dose administered as a subcutaneous injection",null,"Clopidogrel Dosing|Clopidogrel in combination with ISIS 681257","\n\n * Motivated and available for duration of study and willing to adhere to protocol\n * Males who are unable to procreate or agree to contraception throughout study\n * Females who are postmenopausal or surgically sterile\n * BMI between 18.5 and 30 kg/m2\n * Weighing greater than or equal to 50kg\n * Normal lab results\n * No known diseases or significant findings on physical exam\n\n","\n\n * Females of childbearing potential\n * Reactions/infection at injection site\n * Hypersensitivity to any drugs or similar drugs to those used in the study\n * Conditions or disease that may interfere with study drug\n * Any significant diseases\n * Known history or familial history of bleeding disorders\n * Drug dependency or abuse\n * Illness within 28 days\n * Previous exposure to other investigational drug within 28 days\n * Blood donations within 28 days",{"$nulls":4},"Actual","2018-01-05","Actual","Anticipated","2018-03-01","Anticipated","2018-02-01","2018-01-02","2018-01-02","2018-02-19",null,null,"Interventional","Other","Sequential Assignment","None (Open Label)","Non-Randomized","18 Years","60 Years","All",null,"Yes","No",{"$nulls":3},"No","No",{"$nulls":19},"Evaluate the effect of multiple doses (2 doses) of ISIS 681257 40 mg subcutaneous injections on the PK of multiple oral doses of clopidogrel in healthy adult subjects","The plasma concentrations of Clopidogrel and ISIS 681257 will be measured at each individual time point.","55 days","Evaluate the safety of multiple doses (2 doses) of ISIS 681257 40 mg subcutaneous injections when co-administered with multiple oral doses of clopidogrel in healthy adult subjects|Evaluate the effect of multiple doses (2 doses) of ISIS 681257 40 mg subcutaneous injections on the pharmacodynamics (antiplatelet activity) of multiple doses of clopidogrel in healthy adult subjects","Safety will be assessed by summarizing the reported adverse events|P2Y12 reaction units (PRUs) will be measured at each individual time point.","55 days",{"$nulls":3},"Mount Royal, Quebec, Canada, H3P 3H5",null,"Canada","Quebec Clinical Site",{"$nulls":4},"2018-02-19","2020-05-25T16:35:28.930","2020-05-26T17:10:42.972","NCT03392051"]
["5ecbf3d0fe30261b1a0481c2","NCT03392051","2018-04-05","Akcea","AKCA","Completed","Drug-drug Interaction Study to Evaluate the Effect of ISIS 681257 on Clopidogrel","Clopidogrel|Isis-681257","P2Y12 Antagonist|GPIIb/IIIa Inhibitor","Yes","['Isis-681257']","No",null,"Phase 1",2,18,"Actual","2017-12-28","2018-03-18",{"$nulls":5},"This is a single center, open label, single sequence, two treatment, two-period drug-drug interaction study to evaluate the effect of multiple doses of ISIS 681257 on the pharmacokinetics of multiple doses of clopidogrel",null,"Drug-Drug Interaction Study To Evaluate The Effect Of Multiple Doses Of ISIS 681257 40 mg Subcutaneous Injections On The Pharmacokinetics And Pharmacodynamics Of Clopidogrel In Healthy Subjects","ISIS 681257-CS11","Elevated Lipoprotein(a)\nCardiovascular Diseases","Healthy Volunteers","Healthy","Healthy","Experimental","Clopidogrel Dosing|Clopidogrel in combination with ISIS 681257","Multiple doses of Clopidogrel to obtain pharmacokinetic information.|Multiple doses of clopidogrel administered with 2 doses of ISIS 681257 at 2 individual timepoints to obtain pharmacokinetic information.","Drug","Clopidogrel|ISIS 681257","75mg tablet administered orally|Xmg dose administered as a subcutaneous injection",null,"Clopidogrel Dosing|Clopidogrel in combination with ISIS 681257","\n\n * Motivated and available for duration of study and willing to adhere to protocol\n * Males who are unable to procreate or agree to contraception throughout study\n * Females who are postmenopausal or surgically sterile\n * BMI between 18.5 and 30 kg/m2\n * Weighing greater than or equal to 50kg\n * Normal lab results\n * No known diseases or significant findings on physical exam\n\n","\n\n * Females of childbearing potential\n * Reactions/infection at injection site\n * Hypersensitivity to any drugs or similar drugs to those used in the study\n * Conditions or disease that may interfere with study drug\n * Any significant diseases\n * Known history or familial history of bleeding disorders\n * Drug dependency or abuse\n * Illness within 28 days\n * Previous exposure to other investigational drug within 28 days\n * Blood donations within 28 days",{"$nulls":4},"Actual","2018-01-05","Actual","Actual","2018-03-18","Actual","2018-04-01","2018-01-02","2018-01-02","2018-04-03",null,null,"Interventional","Other","Sequential Assignment","None (Open Label)","Non-Randomized","18 Years","60 Years","All",null,"Yes","No",{"$nulls":3},"No","No",{"$nulls":19},"Evaluate the effect of multiple doses (2 doses) of ISIS 681257 40 mg subcutaneous injections on the PK of multiple oral doses of clopidogrel in healthy adult subjects","The plasma concentrations of Clopidogrel and ISIS 681257 will be measured at each individual time point.","55 days","Evaluate the safety of multiple doses (2 doses) of ISIS 681257 40 mg subcutaneous injections when co-administered with multiple oral doses of clopidogrel in healthy adult subjects|Evaluate the effect of multiple doses (2 doses) of ISIS 681257 40 mg subcutaneous injections on the pharmacodynamics (antiplatelet activity) of multiple doses of clopidogrel in healthy adult subjects","Safety will be assessed by summarizing the reported adverse events|P2Y12 reaction units (PRUs) will be measured at each individual time point.","55 days",{"$nulls":3},"Mount Royal, Quebec, Canada, H3P 3H5",null,"Canada","Quebec Clinical Site",{"$nulls":4},"2018-04-03","2020-05-25T16:35:28.845","2020-05-26T17:10:42.972","NCT03392051"]
["5ecbf3d0feab101b155307f2","NCT03392064","2018-01-05","Amgen","AMGN","Not yet recruiting","A Phase 1 Study Evaluating the Safety, Tolerability and Efficacy of AMG 119 in Subjects With RR SCLC","Amg-119","CAR-T","Yes","['Amg-119']","Yes","['CAR-T']","Phase 1",1,41,"Anticipated","2018-04-02","2020-03-22","DLT","Dose Limiting Toxicity",{"$nulls":3},"A study to evaluate the safety and tolerability of AMG 119 in adult subjects with Relapsed/Refractory Small Cell Lung Cancer (SCLC) and determine the appropriate cell dose.","This is a phase 1, first-in-human study to evaluate the safety and tolerability of AMG 119, an investigational, Chimeric Antigen Receptor T cell therapy in subjects with relapsed/refractory small cell lung cancer who progressed after at least 1 platinum based chemotherapy regimen.","A Phase 1 Study Evaluating the Safety, Tolerability and Efficacy of AMG 119 in Subjects With Relapsed/Refractory Small Cell Lung Cancer",20170124,"Small Cell Lung Cancer","Lung Cancer|Small Cell Lung Cancer","Oncology Solid Tumor","Oncology","Experimental","AMG 119 Treatment","AMG 119 administered as a one-time intravenous infusion at different cell dose levels","Biological","AMG 119","Investigational, adoptive cellular immunotherapy for the treatment of small cell lung cancer",null,"AMG 119 Treatment","\n\n * Subject has provided informed consent prior to initiation of any study-specific activities/procedures;\n * Age â‰¥ 18 years old at the time of signing the informed consent; Histologically confirmed Small Cell Lung Cancer (SCLC) with radiographically documented disease progression or recurrence after at least one platinum-based regimen:\n * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1\n * At least 2 measurable lesions as defined per modified RECIST 1.1 by CT or MRI performed after the last line of anti-cancer therapy within 28 days of enrollment\n * No evidence of CNS metastasis by MRI or CT of the brain performed within 28 days of enrollment 107 -Adequate organ function\n * Other inclusion criteria may apply\n\n","\n\n * History of other malignancy within the past 2 years prior to enrollment exceptions may apply\n * History of organ transplant\n * Major surgery within 28 days of enrollment\n * Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association > class II) within 12 months of enrollment\n * History of arterial thrombosis (eg, stroke or transient ischemic attack) within 12 months of enrollment\n * Prior anti-cancer therapy as specified below: At least 3 half-lives from enrollment must have elapsed from any prior systemic inhibitory/stimulatory immune checkpoint molecule therapy (eg, ipilimumab, nivolumab, pembrolizumab, atezolizumab, OX40 agonists, 4-1BB agonists, etc). Other anti-cancer therapy (chemotherapy, antibody therapy, molecular targeted therapy, or investigational agent) within 28 days prior to enrollment. Radiation therapy completed within 28 days prior to enrollment. Prior CAR T therapy\n * Has evidence of interstitial lung disease or active, non-infectious pneumonitis Other exclusion criteria may apply",{"$nulls":4},"Actual","2018-01-05","Actual","Anticipated","2020-03-22","Anticipated","2017-12-01","2018-01-02","2018-01-02","2018-01-02","No","AMG 119\nCART","Interventional","Treatment","Sequential Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No",null,null,"URL: http://www.amgentrials.com [http://www.amgentrials.com] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: AmgenTrials clinical trials website",null,"Yes","No",{"$nulls":19},"Subject incidence of dose limiting toxicity","Number of dose limiting toxicity","Up to 3 years",{"$nulls":3},"medinfo@amgen.com","Amgen Call Center","866-572-6436",{"$nulls":7},"MD","2018-01-02","2020-05-25T16:35:28.856","2020-05-26T17:10:42.972","NCT03392064"]
["5ecbf3d111702c1b1b9169d7","NCT03392064","2018-04-12","Amgen","AMGN","Not yet recruiting","A Phase 1 Study Evaluating the Safety, Tolerability and Efficacy of AMG 119 in Subjects With RR SCLC","Amg-119","CAR-T","Yes","['Amg-119']","Yes","['CAR-T']","Phase 1",1,41,"Anticipated","2018-05-31","2020-05-20","DLT","Dose Limiting Toxicity",{"$nulls":3},"A study to evaluate the safety and tolerability of AMG 119 in adult subjects with Relapsed/Refractory Small Cell Lung Cancer (SCLC) and determine the appropriate cell dose.","This is a phase 1, first-in-human study to evaluate the safety and tolerability of AMG 119, an investigational, Chimeric Antigen Receptor T cell therapy in subjects with relapsed/refractory small cell lung cancer who progressed after at least 1 platinum based chemotherapy regimen.","A Phase 1 Study Evaluating the Safety, Tolerability and Efficacy of AMG 119 in Subjects With Relapsed/Refractory Small Cell Lung Cancer",20170124,"Small Cell Lung Cancer","Lung Cancer|Small Cell Lung Cancer","Oncology Solid Tumor","Oncology","Experimental","AMG 119 Treatment","AMG 119 administered as a one-time intravenous infusion at different cell dose levels","Biological","AMG 119","Investigational, adoptive cellular immunotherapy for the treatment of small cell lung cancer",null,"AMG 119 Treatment","\n\n * Subject has provided informed consent prior to initiation of any study-specific activities/procedures;\n * Age â‰¥ 18 years old at the time of signing the informed consent; Histologically confirmed Small Cell Lung Cancer (SCLC) with radiographically documented disease progression or recurrence after at least one platinum-based regimen:\n * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1\n * At least 2 measurable lesions as defined per modified RECIST 1.1 by CT or MRI performed after the last line of anti-cancer therapy within 28 days of enrollment\n * No evidence of CNS metastasis by MRI or CT of the brain performed within 28 days of enrollment 107 -Adequate organ function\n * Other inclusion criteria may apply\n\n","\n\n * History of other malignancy within the past 2 years prior to enrollment exceptions may apply\n * History of organ transplant\n * Major surgery within 28 days of enrollment\n * Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association > class II) within 12 months of enrollment\n * History of arterial thrombosis (eg, stroke or transient ischemic attack) within 12 months of enrollment\n * Prior anti-cancer therapy as specified below: At least 3 half-lives from enrollment must have elapsed from any prior systemic inhibitory/stimulatory immune checkpoint molecule therapy (eg, ipilimumab, nivolumab, pembrolizumab, atezolizumab, OX40 agonists, 4-1BB agonists, etc). Other anti-cancer therapy (chemotherapy, antibody therapy, molecular targeted therapy, or investigational agent) within 28 days prior to enrollment. Radiation therapy completed within 28 days prior to enrollment. Prior CAR T therapy\n * Has evidence of interstitial lung disease or active, non-infectious pneumonitis Other exclusion criteria may apply",{"$nulls":4},"Actual","2018-01-05","Actual","Anticipated","2020-05-20","Anticipated","2018-04-01","2018-01-02","2018-01-02","2018-04-11","No","AMG 119\nCART","Interventional","Treatment","Sequential Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No",null,null,"URL: http://www.amgentrials.com [http://www.amgentrials.com] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: AmgenTrials clinical trials website",null,"Yes","No",{"$nulls":19},"Subject incidence of dose limiting toxicity","Number of dose limiting toxicity","Up to 3 years",{"$nulls":3},"medinfo@amgen.com","Amgen Call Center","866-572-6436",{"$nulls":7},"MD","2018-04-11","2020-05-25T16:35:29.177","2020-05-26T17:10:42.972","NCT03392064"]
["5ecbf3d111702c1b1b9169d6","NCT03392064","2018-05-08","Amgen","AMGN","Not yet recruiting","A Phase 1 Study Evaluating the Safety, Tolerability and Efficacy of AMG 119 in Subjects With RR SCLC","Amg-119","CAR-T","Yes","['Amg-119']","Yes","['CAR-T']","Phase 1",1,41,"Anticipated","2018-05-31","2020-05-20","DLT","Dose Limiting Toxicity",{"$nulls":3},"A study to evaluate the safety and tolerability of AMG 119 in adult subjects with Relapsed/Refractory Small Cell Lung Cancer (SCLC) and determine the appropriate cell dose.","This is a phase 1, first-in-human study to evaluate the safety and tolerability of AMG 119, an investigational, Chimeric Antigen Receptor T cell therapy in subjects with relapsed/refractory small cell lung cancer who progressed after at least 1 platinum based chemotherapy regimen.","A Phase 1 Study Evaluating the Safety, Tolerability and Efficacy of AMG 119 in Subjects With Relapsed/Refractory Small Cell Lung Cancer",20170124,"Small Cell Lung Cancer","Lung Cancer|Small Cell Lung Cancer","Oncology Solid Tumor","Oncology","Experimental","AMG 119 Treatment","AMG 119 administered as a one-time intravenous infusion at different cell dose levels","Biological","AMG 119","Investigational, adoptive cellular immunotherapy for the treatment of small cell lung cancer",null,"AMG 119 Treatment","\n\n * Subject has provided informed consent prior to initiation of any study-specific activities/procedures;\n * Age â‰¥ 18 years old at the time of signing the informed consent; Histologically confirmed Small Cell Lung Cancer (SCLC) with radiographically documented disease progression or recurrence after at least one platinum-based regimen:\n * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1\n * At least 2 measurable lesions as defined per modified RECIST 1.1 by CT or MRI performed after the last line of anti-cancer therapy within 28 days of enrollment\n * No evidence of CNS metastasis by MRI or CT of the brain performed within 28 days of enrollment 107 -Adequate organ function\n * Other inclusion criteria may apply\n\n","\n\n * History of other malignancy within the past 2 years prior to enrollment except: Malignancy (other than in situ) treated with curative intent and with no known active disease present for â‰¥ 2 years before enrollment and felt to be at low risk for recurrence by the treating physician; Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease; Adequately treated in situ cancer without evidence of disease; Prostatic intraepithelial neoplasia without evidence of prostate cancer; Adequately treated urothelial papillary noninvasive carcinoma.\n * History of organ transplant.\n * Major surgery within 28 days of enrollment.\n * Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association > class II) within 12 months of enrollment.\n * History of arterial thrombosis (eg, stroke or transient ischemic attack) within 12 months of enrollment.\n * Presence of fungal, bacterial, viral, or other infection requiring IV antimicrobials for management within 7 days of enrollment. Note: Simple UTI and uncomplicated bacterial pharyngitis are permitted if responding to active treatment and after consultation with sponsor.\n * Subject has known sensitivity and immediate hypersensitivity to any components of AMG 119 or conditioning regimen (cyclophosphamide and fludarabine).\n * Evidence of a bleeding diathesis.\n * Systemic corticosteroid therapy within 7 days before enrollment. Note: Topical and inhaled corticosteroids in standard doses and physiologic replacement for subjects with adrenal insufficiency are allowed. â‰¥ 5 mg/day of prednisone or equivalent doses of other corticosteroids are not allowed.\n * Prior anti-cancer therapy as specified below: At least 28 days from enrollment must have elapsed from any prior systemic inhibitory/stimulatory immune checkpoint molecule therapy (eg, ipilimumab, nivolumab, pembrolizumab, atezolizumab, OX40 agonists, 4-1BB agonists, etc). Note: Patients who experienced immune -related pneumonitis, pituitary or thyroid dysfunction, or pancreatitis while on treatment with immune-oncology agents will be excluded; Other anti-cancer therapy (chemotherapy, antibody therapy, molecular targeted therapy, or investigational agent) within 14 days prior to enrollment; Radiation therapy completed within 14 days prior to enrollment; Prior CAR T therapy or other genetically modified T cell therapy.",{"$nulls":4},"Actual","2018-01-05","Actual","Anticipated","2020-05-20","Anticipated","2018-04-01","2018-01-02","2018-01-02","2018-05-07","No","AMG 119\nCART","Interventional","Treatment","Sequential Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No",null,null,"URL: http://www.amgentrials.com [http://www.amgentrials.com] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: AmgenTrials clinical trials website",null,"Yes","No",{"$nulls":19},"Subject incidence of dose limiting toxicity","Number of dose limiting toxicity","Up to 3 years",{"$nulls":3},"medinfo@amgen.com","Amgen Call Center","866-572-6436",{"$nulls":7},"MD","2018-05-07","2020-05-25T16:35:29.029","2020-05-26T17:10:42.972","NCT03392064"]
["5ecbf3d1feab101b155307f3","NCT03392064","2018-06-15","Amgen","AMGN","Recruiting","A Phase 1 Study Evaluating the Safety, Tolerability and Efficacy of AMG 119 in Subjects With RR SCLC","Amg-119","CAR-T","Yes","['Amg-119']","Yes","['CAR-T']","Phase 1",1,41,"Anticipated","2018-06-30","2020-05-20","DLT","Dose Limiting Toxicity",{"$nulls":3},"A study to evaluate the safety and tolerability of AMG 119 in adult subjects with Relapsed/Refractory Small Cell Lung Cancer (SCLC) and determine the appropriate cell dose.","This is a phase 1, first-in-human study to evaluate the safety and tolerability of AMG 119, an investigational, Chimeric Antigen Receptor T cell therapy targeting delta-like protein 3 (DLL3) in subjects with relapsed/refractory small cell lung cancer who progressed after at least 1 platinum based chemotherapy regimen.","A Phase 1 Study Evaluating the Safety, Tolerability and Efficacy of AMG 119 in Subjects With Relapsed/Refractory Small Cell Lung Cancer",20170124,"Small Cell Lung Cancer","Lung Cancer|Small Cell Lung Cancer","Oncology Solid Tumor","Oncology","Experimental","AMG 119 Treatment","AMG 119 administered as a one-time intravenous infusion at different cell dose levels","Biological","AMG 119","Investigational, adoptive cellular immunotherapy for the treatment of small cell lung cancer",null,"AMG 119 Treatment","\n\n * Subject has provided informed consent prior to initiation of any study-specific activities/procedures;\n * Age â‰¥ 18 years old at the time of signing the informed consent\n * Histologically confirmed Small Cell Lung Cancer (SCLC) with radiographically documented disease progression or recurrence after at least one platinum-based regimen:\n * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1\n * At least 2 measurable lesions as defined per modified RECIST 1.1 by CT or MRI performed after the last line of anti-cancer therapy within 28 days of enrollment\n * No evidence of CNS metastasis by MRI or CT of the brain performed within 28 days of enrollment\n * Adequate organ function\n * Other inclusion criteria may apply\n\n","\n\n * History of other malignancy within the past 2 years prior to enrollment except: Malignancy (other than in situ) treated with curative intent and with no known active disease present for â‰¥ 2 years before enrollment and felt to be at low risk for recurrence by the treating physician; Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease; Adequately treated in situ cancer without evidence of disease; Prostatic intraepithelial neoplasia without evidence of prostate cancer; Adequately treated urothelial papillary noninvasive carcinoma.\n * History of organ transplant.\n * Major surgery within 28 days of enrollment.\n * Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association > class II) within 12 months of enrollment.\n * History of arterial thrombosis (eg, stroke or transient ischemic attack) within 12 months of enrollment.\n * Presence of fungal, bacterial, viral, or other infection requiring IV antimicrobials for management within 7 days of enrollment. Note: Simple UTI and uncomplicated bacterial pharyngitis are permitted if responding to active treatment and after consultation with sponsor.\n * Subject has known sensitivity and immediate hypersensitivity to any components of AMG 119 or conditioning regimen (cyclophosphamide and fludarabine).\n * Evidence of a bleeding diathesis.\n * Systemic corticosteroid therapy within 7 days before enrollment. Note: Topical and inhaled corticosteroids in standard doses and physiologic replacement for subjects with adrenal insufficiency are allowed. â‰¥ 5 mg/day of prednisone or equivalent doses of other corticosteroids are not allowed.\n * Prior anti-cancer therapy as specified below: At least 28 days from enrollment must have elapsed from any prior systemic inhibitory/stimulatory immune checkpoint molecule therapy (eg, ipilimumab, nivolumab, pembrolizumab, atezolizumab, OX40 agonists, 4-1BB agonists, etc). Note: Patients who experienced immune -related pneumonitis, pituitary or thyroid dysfunction, or pancreatitis while on treatment with immune-oncology agents will be excluded; Other anti-cancer therapy (chemotherapy, antibody therapy, molecular targeted therapy, or investigational agent) within 14 days prior to enrollment; Radiation therapy completed within 14 days prior to enrollment; Prior CAR T therapy or other genetically modified T cell therapy.\n * Primary immunodeficiency\n * History of autoimmune disease resulting in end organ injury or requiring systemic immunosuppression/systemic disease modifying agents within the last 2 years prior to enrollment\n * Unresolved toxicities from prior anti-tumor therapy (defined as not having resolved to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 grade 1, or to levels dictated in the eligibility criteria) with the exception of alopecia or toxicities from prior anti-tumor therapy that are considered irreversible [defined as having been present and stable for > 28 days] which may be allowed if they are not otherwise described in the exclusion criteria AND there is agreement to allow by both the investigator and Amgen\n * Received live vaccine within 28 days prior to enrollment\n * Exclusion of hepatitis infection based on the following results and/or criteria: Positive for hepatitis B surface antigen (HBsAg) (indicative of chronic hepatitis B or recent acute hepatitis B); Negative HBsAg and positive for hepatitis B core antibody: hepatitis B virus DNA by polymerase chain reaction (PCR) is necessary. Detectable hepatitis B virus DNA suggests occult hepatitis B\n * Positive Hepatitis C virus antibody (HCVAb): hepatitis C virus RNA by PCR is necessary. Detectable hepatitis C virus RNA suggests chronic hepatitis C\n * History or evidence of any other clinically significant disorder, condition or disease that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion\n * Other exclusion criteria may apply",{"$nulls":4},"Actual","2018-01-05","Actual","Anticipated","2020-05-20","Anticipated","2018-06-01","2018-01-02","2018-01-02","2018-06-14","No","AMG 119\nCART\nDLL3","Interventional","Treatment","Sequential Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No",null,null,"URL: http://www.amgentrials.com [http://www.amgentrials.com] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: AmgenTrials clinical trials website",null,"Yes","No",{"$nulls":19},"Subject incidence of dose limiting toxicity","Number of dose limiting toxicity","Up to 3 years",{"$nulls":3},"medinfo@amgen.com","Amgen Call Center","866-572-6436","Houston, Texas, United States, 77030","Texas","United States","Research Site",{"$nulls":3},"MD","2018-06-14","2020-05-25T16:35:29.109","2020-05-26T17:10:42.972","NCT03392064"]
["5ecbf3d0e2561b1b11905cbe","NCT03392064","2018-07-30","Amgen","AMGN","Recruiting","A Phase 1 Study Evaluating the Safety, Tolerability and Efficacy of AMG 119 in Subjects With RR SCLC","Amg-119","CAR-T","Yes","['Amg-119']","Yes","['CAR-T']","Phase 1",1,41,"Anticipated","2018-08-10","2020-07-02","DLT","Dose Limiting Toxicity",{"$nulls":3},"A study to evaluate the safety and tolerability of AMG 119 in adult subjects with Relapsed/Refractory Small Cell Lung Cancer (SCLC) and determine the appropriate cell dose.","This is a phase 1, first-in-human study to evaluate the safety and tolerability of AMG 119, an investigational, Chimeric Antigen Receptor T cell therapy targeting delta-like protein 3 (DLL3) in subjects with relapsed/refractory small cell lung cancer who progressed after at least 1 platinum based chemotherapy regimen.","A Phase 1 Study Evaluating the Safety, Tolerability and Efficacy of AMG 119 in Subjects With Relapsed/Refractory Small Cell Lung Cancer",20170124,"Small Cell Lung Cancer","Lung Cancer|Small Cell Lung Cancer","Oncology Solid Tumor","Oncology","Experimental","AMG 119 Treatment","AMG 119 administered as a one-time intravenous infusion at different cell dose levels","Biological","AMG 119","Investigational, adoptive cellular immunotherapy for the treatment of small cell lung cancer",null,"AMG 119 Treatment","\n\n * Subject has provided informed consent prior to initiation of any study-specific activities/procedures;\n * Age â‰¥ 18 years old at the time of signing the informed consent\n * Histologically confirmed Small Cell Lung Cancer (SCLC) with radiographically documented disease progression or recurrence after at least one platinum-based regimen:\n * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1\n * At least 2 measurable lesions as defined per modified RECIST 1.1 by CT or MRI performed after the last line of anti-cancer therapy within 28 days of enrollment\n * No evidence of CNS metastasis by MRI or CT of the brain performed within 28 days of enrollment\n * Adequate organ function\n * Other inclusion criteria may apply\n\n","\n\n * History of other malignancy within the past 2 years prior to enrollment except: Malignancy (other than in situ) treated with curative intent and with no known active disease present for â‰¥ 2 years before enrollment and felt to be at low risk for recurrence by the treating physician; Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease; Adequately treated in situ cancer without evidence of disease; Prostatic intraepithelial neoplasia without evidence of prostate cancer; Adequately treated urothelial papillary noninvasive carcinoma.\n * History of organ transplant.\n * Major surgery within 28 days of enrollment.\n * Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association > class II) within 12 months of enrollment.\n * History of arterial thrombosis (eg, stroke or transient ischemic attack) within 12 months of enrollment.\n * Presence of fungal, bacterial, viral, or other infection requiring IV antimicrobials for management within 7 days of enrollment. Note: Simple UTI and uncomplicated bacterial pharyngitis are permitted if responding to active treatment and after consultation with sponsor.\n * Subject has known sensitivity and immediate hypersensitivity to any components of AMG 119 or conditioning regimen (cyclophosphamide and fludarabine).\n * Evidence of a bleeding diathesis.\n * Systemic corticosteroid therapy within 7 days before enrollment. Note: Topical and inhaled corticosteroids in standard doses and physiologic replacement for subjects with adrenal insufficiency are allowed. â‰¥ 5 mg/day of prednisone or equivalent doses of other corticosteroids are not allowed.\n * Prior anti-cancer therapy as specified below: At least 28 days from enrollment must have elapsed from any prior systemic inhibitory/stimulatory immune checkpoint molecule therapy (eg, ipilimumab, nivolumab, pembrolizumab, atezolizumab, OX40 agonists, 4-1BB agonists, etc). Note: Patients who experienced immune -related pneumonitis, pituitary or thyroid dysfunction, or pancreatitis while on treatment with immune-oncology agents will be excluded; Other anti-cancer therapy (chemotherapy, antibody therapy, molecular targeted therapy, or investigational agent) within 14 days prior to enrollment; Radiation therapy completed within 14 days prior to enrollment; Prior CAR T therapy or other genetically modified T cell therapy.\n * Primary immunodeficiency\n * History of autoimmune disease resulting in end organ injury or requiring systemic immunosuppression/systemic disease modifying agents within the last 2 years prior to enrollment\n * Unresolved toxicities from prior anti-tumor therapy (defined as not having resolved to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 grade 1, or to levels dictated in the eligibility criteria) with the exception of alopecia or toxicities from prior anti-tumor therapy that are considered irreversible [defined as having been present and stable for > 28 days] which may be allowed if they are not otherwise described in the exclusion criteria AND there is agreement to allow by both the investigator and Amgen\n * Received live vaccine within 28 days prior to enrollment\n * Exclusion of hepatitis infection based on the following results and/or criteria: Positive for hepatitis B surface antigen (HBsAg) (indicative of chronic hepatitis B or recent acute hepatitis B); Negative HBsAg and positive for hepatitis B core antibody: hepatitis B virus DNA by polymerase chain reaction (PCR) is necessary. Detectable hepatitis B virus DNA suggests occult hepatitis B\n * Positive Hepatitis C virus antibody (HCVAb): hepatitis C virus RNA by PCR is necessary. Detectable hepatitis C virus RNA suggests chronic hepatitis C\n * History or evidence of any other clinically significant disorder, condition or disease that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion\n * Other exclusion criteria may apply",{"$nulls":4},"Actual","2018-01-05","Actual","Anticipated","2020-07-02","Anticipated","2018-07-01","2018-01-02","2018-01-02","2018-07-27","No","AMG 119\nCART\nDLL3","Interventional","Treatment","Sequential Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No",null,null,"URL: http://www.amgentrials.com [http://www.amgentrials.com] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: AmgenTrials clinical trials website",null,"Yes","No",{"$nulls":19},"Subject incidence of dose limiting toxicity","Number of dose limiting toxicity","Up to 3 years",{"$nulls":3},"medinfo@amgen.com","Amgen Call Center","866-572-6436","Houston, Texas, United States, 77030","Texas","United States","University Of Texas Md Anderson Cancer Center",{"$nulls":3},"MD","2018-07-27","2020-05-25T16:35:28.936","2020-05-26T17:10:42.972","NCT03392064"]
["5ecbf3d1307e3d1b1f8d9c53","NCT03392064","2018-09-07","Amgen","AMGN","Recruiting","A Phase 1 Study Evaluating the Safety, Tolerability and Efficacy of AMG 119 in Subjects With RR SCLC","Amg-119","CAR-T","Yes","['Amg-119']","Yes","['CAR-T']","Phase 1",1,41,"Anticipated","2018-09-10","2020-09-09","DLT","Dose Limiting Toxicity",{"$nulls":3},"A study to evaluate the safety and tolerability of AMG 119 in adult subjects with Relapsed/Refractory Small Cell Lung Cancer (SCLC) and determine the appropriate cell dose.","This is a phase 1, first-in-human study to evaluate the safety and tolerability of AMG 119, an investigational, Chimeric Antigen Receptor T cell therapy targeting delta-like protein 3 (DLL3) in subjects with relapsed/refractory small cell lung cancer who progressed after at least 1 platinum based chemotherapy regimen.","A Phase 1 Study Evaluating the Safety, Tolerability and Efficacy of AMG 119 in Subjects With Relapsed/Refractory Small Cell Lung Cancer",20170124,"Small Cell Lung Cancer","Lung Cancer|Small Cell Lung Cancer","Oncology Solid Tumor","Oncology","Experimental","AMG 119 Treatment","AMG 119 administered as a one-time intravenous infusion at different cell dose levels","Biological","AMG 119","Investigational, adoptive cellular immunotherapy for the treatment of small cell lung cancer",null,"AMG 119 Treatment","\n\n * Subject has provided informed consent prior to initiation of any study-specific activities/procedures;\n * Age â‰¥ 18 years old at the time of signing the informed consent\n * Histologically confirmed Small Cell Lung Cancer (SCLC) with radiographically documented disease progression or recurrence after at least one platinum-based regimen:\n * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1\n * At least 2 measurable lesions as defined per modified RECIST 1.1 by CT or MRI performed after the last line of anti-cancer therapy within 28 days of enrollment\n * Subjects with treated brain metastases are eligible provided they meet the following criteria:\n * - Definitive therapy was completed at least 2 weeks prior to enrollment.\n * - No evidence of radiographic CNS progression or CNS disease following definitive therapy and by the time of study screening. Patients manifesting progression in lesions previously treated with stereotactic radiosurgery may still be eligible if pseudoprogression can be demonstrated by appropriate means and after discussion with the medical monitor.\n * - Any CNS disease is asymptomatic, any neurologic symptoms due to CNS disease have returned to baseline or are deemed irreversible, the patient is off steroids for at least 7 days (physiologic doses of steroids are permitted), and the patient is off or on stable doses of anti-epileptic drugs for malignant CNS disease.\n * Adequate organ function\n * Other inclusion criteria may apply\n\n","\n\n * History of other malignancy within the past 2 years prior to enrollment except: Malignancy (other than in situ) treated with curative intent and with no known active disease present for â‰¥ 2 years before enrollment and felt to be at low risk for recurrence by the treating physician; Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease; Adequately treated in situ cancer without evidence of disease; Prostatic intraepithelial neoplasia without evidence of prostate cancer; Adequately treated urothelial papillary noninvasive carcinoma.\n * History of organ transplant.\n * Major surgery within 28 days of enrollment.\n * Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association > class II) within 12 months of enrollment.\n * History of arterial thrombosis (eg, stroke or transient ischemic attack) within 12 months of enrollment.\n * Untreated or symptomatic brain metastases and leptomeningeal disease\n * Presence of fungal, bacterial, viral, or other infection requiring IV antimicrobials for management within 7 days of enrollment. Note: Simple UTI and uncomplicated bacterial pharyngitis are permitted if responding to active treatment and after consultation with sponsor.\n * Subject has known sensitivity and immediate hypersensitivity to any components of AMG 119 or conditioning regimen (cyclophosphamide and fludarabine).\n * Evidence of a bleeding diathesis.\n * Systemic corticosteroid therapy within 7 days before enrollment. Note: Topical and inhaled corticosteroids in standard doses and physiologic replacement for subjects with adrenal insufficiency are allowed. â‰¥ 5 mg/day of prednisone or equivalent doses of other corticosteroids are not allowed.\n * Prior anti-cancer therapy as specified below: At least 28 days from enrollment must have elapsed from any prior systemic inhibitory/stimulatory immune checkpoint molecule therapy (eg, ipilimumab, nivolumab, pembrolizumab, atezolizumab, OX40 agonists, 4-1BB agonists, etc). Note: Patients who experienced immune -related pneumonitis, pituitary or thyroid dysfunction, or pancreatitis while on treatment with immune-oncology agents will be excluded; Other anti-cancer therapy (chemotherapy, antibody therapy, molecular targeted therapy, or investigational agent) within 14 days prior to enrollment; Radiation therapy completed within 14 days prior to enrollment; Prior CAR T therapy or other genetically modified T cell therapy.\n * Primary immunodeficiency\n * History of autoimmune disease resulting in end organ injury or requiring systemic immunosuppression/systemic disease modifying agents within the last 2 years prior to enrollment\n * Unresolved toxicities from prior anti-tumor therapy (defined as not having resolved to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 grade 1, or to levels dictated in the eligibility criteria) with the exception of alopecia or toxicities from prior anti-tumor therapy that are considered irreversible [defined as having been present and stable for > 28 days] which may be allowed if they are not otherwise described in the exclusion criteria AND there is agreement to allow by both the investigator and Amgen\n * Received live vaccine within 28 days prior to enrollment\n * Exclusion of hepatitis infection based on the following results and/or criteria: Positive for hepatitis B surface antigen (HBsAg) (indicative of chronic hepatitis B or recent acute hepatitis B); Negative HBsAg and positive for hepatitis B core antibody: hepatitis B virus DNA by polymerase chain reaction (PCR) is necessary. Detectable hepatitis B virus DNA suggests occult hepatitis B\n * Positive Hepatitis C virus antibody (HCVAb): hepatitis C virus RNA by PCR is necessary. Detectable hepatitis C virus RNA suggests chronic hepatitis C\n * History or evidence of any other clinically significant disorder, condition or disease that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion\n * Other exclusion criteria may apply",{"$nulls":4},"Actual","2018-01-05","Actual","Anticipated","2020-09-09","Anticipated","2018-09-01","2018-01-02","2018-01-02","2018-09-06","No","AMG 119\nCART\nDLL3","Interventional","Treatment","Sequential Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No",null,null,"URL: http://www.amgentrials.com [http://www.amgentrials.com] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: AmgenTrials clinical trials website",null,"Yes","No",{"$nulls":19},"Subject incidence of dose limiting toxicity","Number of dose limiting toxicity","Up to 3 years",{"$nulls":3},"medinfo@amgen.com","Amgen Call Center","866-572-6436","Houston, Texas, United States, 77030","Texas","United States","Research Site",{"$nulls":3},"MD","2018-09-06","2020-05-25T16:35:29.065","2020-05-26T17:10:42.972","NCT03392064"]
["5ecbf3d1fe30261b1a0481c4","NCT03392064","2018-09-17","Amgen","AMGN","Recruiting","A Phase 1 Study Evaluating the Safety, Tolerability and Efficacy of AMG 119 in Subjects With RR SCLC","Amg-119","CAR-T","Yes","['Amg-119']","Yes","['CAR-T']","Phase 1",1,41,"Anticipated","2018-09-10","2020-09-09","DLT","Dose Limiting Toxicity",{"$nulls":3},"A study to evaluate the safety and tolerability of AMG 119 in adult subjects with Relapsed/Refractory Small Cell Lung Cancer (SCLC) and determine the appropriate cell dose.","This is a phase 1, first-in-human study to evaluate the safety and tolerability of AMG 119, an investigational, Chimeric Antigen Receptor T cell therapy targeting delta-like protein 3 (DLL3) in subjects with relapsed/refractory small cell lung cancer who progressed after at least 1 platinum based chemotherapy regimen.","A Phase 1 Study Evaluating the Safety, Tolerability and Efficacy of AMG 119 in Subjects With Relapsed/Refractory Small Cell Lung Cancer",20170124,"Small Cell Lung Cancer","Lung Cancer|Small Cell Lung Cancer","Oncology Solid Tumor","Oncology","Experimental","AMG 119 Treatment","AMG 119 administered as a one-time intravenous infusion at different cell dose levels","Biological","AMG 119","Investigational, adoptive cellular immunotherapy for the treatment of small cell lung cancer",null,"AMG 119 Treatment","\n\n * Subject has provided informed consent prior to initiation of any study-specific activities/procedures;\n * Age â‰¥ 18 years old at the time of signing the informed consent\n * Histologically confirmed Small Cell Lung Cancer (SCLC) with radiographically documented disease progression or recurrence after at least one platinum-based regimen:\n * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1\n * At least 2 measurable lesions as defined per modified RECIST 1.1 by CT or MRI performed after the last line of anti-cancer therapy within 28 days of enrollment\n * Subjects with treated brain metastases are eligible provided they meet the following criteria:\n * - Definitive therapy was completed at least 2 weeks prior to enrollment.\n * - No evidence of radiographic CNS progression or CNS disease following definitive therapy and by the time of study screening. Patients manifesting progression in lesions previously treated with stereotactic radiosurgery may still be eligible if pseudoprogression can be demonstrated by appropriate means and after discussion with the medical monitor.\n * - Any CNS disease is asymptomatic, any neurologic symptoms due to CNS disease have returned to baseline or are deemed irreversible, the patient is off steroids for at least 7 days (physiologic doses of steroids are permitted), and the patient is off or on stable doses of anti-epileptic drugs for malignant CNS disease.\n * Adequate organ function\n * Other inclusion criteria may apply\n\n","\n\n * History of other malignancy within the past 2 years prior to enrollment except: Malignancy (other than in situ) treated with curative intent and with no known active disease present for â‰¥ 2 years before enrollment and felt to be at low risk for recurrence by the treating physician; Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease; Adequately treated in situ cancer without evidence of disease; Prostatic intraepithelial neoplasia without evidence of prostate cancer; Adequately treated urothelial papillary noninvasive carcinoma.\n * History of organ transplant.\n * Major surgery within 28 days of enrollment.\n * Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association > class II) within 12 months of enrollment.\n * History of arterial thrombosis (eg, stroke or transient ischemic attack) within 12 months of enrollment.\n * Untreated or symptomatic brain metastases and leptomeningeal disease\n * Presence of fungal, bacterial, viral, or other infection requiring IV antimicrobials for management within 7 days of enrollment. Note: Simple UTI and uncomplicated bacterial pharyngitis are permitted if responding to active treatment and after consultation with sponsor.\n * Subject has known sensitivity and immediate hypersensitivity to any components of AMG 119 or conditioning regimen (cyclophosphamide and fludarabine).\n * Evidence of a bleeding diathesis.\n * Systemic corticosteroid therapy within 7 days before enrollment. Note: Topical and inhaled corticosteroids in standard doses and physiologic replacement for subjects with adrenal insufficiency are allowed. â‰¥ 5 mg/day of prednisone or equivalent doses of other corticosteroids are not allowed.\n * Prior anti-cancer therapy as specified below: At least 28 days from enrollment must have elapsed from any prior systemic inhibitory/stimulatory immune checkpoint molecule therapy (eg, ipilimumab, nivolumab, pembrolizumab, atezolizumab, OX40 agonists, 4-1BB agonists, etc). Note: Patients who experienced immune -related pneumonitis, pituitary or thyroid dysfunction, or pancreatitis while on treatment with immune-oncology agents will be excluded; Other anti-cancer therapy (chemotherapy, antibody therapy, molecular targeted therapy, or investigational agent) within 14 days prior to enrollment; Radiation therapy completed within 14 days prior to enrollment; Prior CAR T therapy or other genetically modified T cell therapy.\n * Primary immunodeficiency\n * History of autoimmune disease resulting in end organ injury or requiring systemic immunosuppression/systemic disease modifying agents within the last 2 years prior to enrollment\n * Unresolved toxicities from prior anti-tumor therapy (defined as not having resolved to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 grade 1, or to levels dictated in the eligibility criteria) with the exception of alopecia or toxicities from prior anti-tumor therapy that are considered irreversible [defined as having been present and stable for > 28 days] which may be allowed if they are not otherwise described in the exclusion criteria AND there is agreement to allow by both the investigator and Amgen\n * Received live vaccine within 28 days prior to enrollment\n * Exclusion of hepatitis infection based on the following results and/or criteria: Positive for hepatitis B surface antigen (HBsAg) (indicative of chronic hepatitis B or recent acute hepatitis B); Negative HBsAg and positive for hepatitis B core antibody: hepatitis B virus DNA by polymerase chain reaction (PCR) is necessary. Detectable hepatitis B virus DNA suggests occult hepatitis B\n * Positive Hepatitis C virus antibody (HCVAb): hepatitis C virus RNA by PCR is necessary. Detectable hepatitis C virus RNA suggests chronic hepatitis C\n * History or evidence of any other clinically significant disorder, condition or disease that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion\n * Other exclusion criteria may apply",{"$nulls":4},"Actual","2018-01-05","Actual","Anticipated","2020-09-09","Anticipated","2018-09-01","2018-01-02","2018-01-02","2018-09-14","No","AMG 119\nCART\nDLL3","Interventional","Treatment","Sequential Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No",null,null,"URL: http://www.amgentrials.com [http://www.amgentrials.com] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: AmgenTrials clinical trials website",null,"Yes","No",{"$nulls":19},"Subject incidence of dose limiting toxicity","Number of dose limiting toxicity","Up to 3 years",{"$nulls":3},"medinfo@amgen.com","Amgen Call Center","866-572-6436","Houston, Texas, United States, 77030","Texas","United States","Research Site",{"$nulls":3},"MD","2018-09-14","2020-05-25T16:35:29.273","2020-05-26T17:10:42.972","NCT03392064"]
["5ecbf3d1e2561b1b11905cbf","NCT03392064","2018-11-06","Amgen","AMGN","Recruiting","A Phase 1 Study Evaluating the Safety, Tolerability and Efficacy of AMG 119 in Subjects With RR SCLC","Amg-119","CAR-T","Yes","['Amg-119']","Yes","['CAR-T']","Phase 1",1,41,"Anticipated","2018-09-10","2020-08-30","DLT","Dose Limiting Toxicity",{"$nulls":3},"A study to evaluate the safety and tolerability of AMG 119 in adult subjects with Relapsed/Refractory Small Cell Lung Cancer (SCLC) and determine the appropriate cell dose.","This is a phase 1, first-in-human study to evaluate the safety and tolerability of AMG 119, an investigational, Chimeric Antigen Receptor T cell therapy targeting delta-like protein 3 (DLL3) in subjects with relapsed/refractory small cell lung cancer who progressed after at least 1 platinum based chemotherapy regimen.","A Phase 1 Study Evaluating the Safety, Tolerability and Efficacy of AMG 119 in Subjects With Relapsed/Refractory Small Cell Lung Cancer",20170124,"Small Cell Lung Cancer","Lung Cancer|Small Cell Lung Cancer","Oncology Solid Tumor","Oncology","Experimental","AMG 119 Treatment","AMG 119 administered as a one-time intravenous infusion at different cell dose levels","Biological","AMG 119","Investigational, adoptive cellular immunotherapy for the treatment of small cell lung cancer",null,"AMG 119 Treatment","\n\n * Subject has provided informed consent prior to initiation of any study-specific activities/procedures;\n * Age â‰¥ 18 years old at the time of signing the informed consent\n * Histologically confirmed Small Cell Lung Cancer (SCLC) with radiographically documented disease progression or recurrence after at least one platinum-based regimen:\n * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1\n * At least 2 measurable lesions as defined per modified RECIST 1.1 by CT or MRI performed after the last line of anti-cancer therapy within 28 days of enrollment\n * Subjects with treated brain metastases are eligible provided they meet the following criteria:\n * - Definitive therapy was completed at least 2 weeks prior to enrollment.\n * - No evidence of radiographic CNS progression or CNS disease following definitive therapy and by the time of study screening. Patients manifesting progression in lesions previously treated with stereotactic radiosurgery may still be eligible if pseudoprogression can be demonstrated by appropriate means and after discussion with the medical monitor.\n * - Any CNS disease is asymptomatic, any neurologic symptoms due to CNS disease have returned to baseline or are deemed irreversible, the patient is off steroids for at least 7 days (physiologic doses of steroids are permitted), and the patient is off or on stable doses of anti-epileptic drugs for malignant CNS disease.\n * Adequate organ function\n * Other inclusion criteria may apply\n\n","\n\n * History of other malignancy within the past 2 years prior to enrollment except: Malignancy (other than in situ) treated with curative intent and with no known active disease present for â‰¥ 2 years before enrollment and felt to be at low risk for recurrence by the treating physician; Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease; Adequately treated in situ cancer without evidence of disease; Prostatic intraepithelial neoplasia without evidence of prostate cancer; Adequately treated urothelial papillary noninvasive carcinoma.\n * History of organ transplant.\n * Major surgery within 28 days of enrollment.\n * Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association > class II) within 12 months of enrollment.\n * History of arterial thrombosis (eg, stroke or transient ischemic attack) within 12 months of enrollment.\n * Untreated or symptomatic brain metastases and leptomeningeal disease\n * Presence of fungal, bacterial, viral, or other infection requiring IV antimicrobials for management within 7 days of enrollment. Note: Simple UTI and uncomplicated bacterial pharyngitis are permitted if responding to active treatment and after consultation with sponsor.\n * Subject has known sensitivity and immediate hypersensitivity to any components of AMG 119 or conditioning regimen (cyclophosphamide and fludarabine).\n * Evidence of a bleeding diathesis.\n * Systemic corticosteroid therapy within 7 days before enrollment. Note: Topical and inhaled corticosteroids in standard doses and physiologic replacement for subjects with adrenal insufficiency are allowed. â‰¥ 5 mg/day of prednisone or equivalent doses of other corticosteroids are not allowed.\n * Prior anti-cancer therapy as specified below: At least 28 days from enrollment must have elapsed from any prior systemic inhibitory/stimulatory immune checkpoint molecule therapy (eg, ipilimumab, nivolumab, pembrolizumab, atezolizumab, OX40 agonists, 4-1BB agonists, etc). Note: Patients who experienced immune -related pneumonitis, pituitary or thyroid dysfunction, or pancreatitis while on treatment with immune-oncology agents will be excluded; Other anti-cancer therapy (chemotherapy, antibody therapy, molecular targeted therapy, or investigational agent) within 14 days prior to enrollment; Radiation therapy completed within 14 days prior to enrollment; Prior CAR T therapy or other genetically modified T cell therapy.\n * Primary immunodeficiency\n * History of autoimmune disease resulting in end organ injury or requiring systemic immunosuppression/systemic disease modifying agents within the last 2 years prior to enrollment\n * Unresolved toxicities from prior anti-tumor therapy (defined as not having resolved to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 grade 1, or to levels dictated in the eligibility criteria) with the exception of alopecia or toxicities from prior anti-tumor therapy that are considered irreversible [defined as having been present and stable for > 28 days] which may be allowed if they are not otherwise described in the exclusion criteria AND there is agreement to allow by both the investigator and Amgen\n * Received live vaccine within 28 days prior to enrollment\n * Exclusion of hepatitis infection based on the following results and/or criteria: Positive for hepatitis B surface antigen (HBsAg) (indicative of chronic hepatitis B or recent acute hepatitis B); Negative HBsAg and positive for hepatitis B core antibody: hepatitis B virus DNA by polymerase chain reaction (PCR) is necessary. Detectable hepatitis B virus DNA suggests occult hepatitis B\n * Positive Hepatitis C virus antibody (HCVAb): hepatitis C virus RNA by PCR is necessary. Detectable hepatitis C virus RNA suggests chronic hepatitis C\n * History or evidence of any other clinically significant disorder, condition or disease that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion\n * Other exclusion criteria may apply",{"$nulls":4},"Actual","2018-01-05","Actual","Anticipated","2020-08-30","Anticipated","2018-11-01","2018-01-02","2018-01-02","2018-11-05","No","AMG 119\nCART\nDLL3","Interventional","Treatment","Sequential Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No","Yes\nDe-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request",null,"URL: http://www.amgentrials.com [http://www.amgentrials.com] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: AmgenTrials clinical trials website",null,"Yes","No",{"$nulls":19},"Subject incidence of dose limiting toxicity","Number of dose limiting toxicity","Up to 3 years",{"$nulls":3},"medinfo@amgen.com","Amgen Call Center","866-572-6436","Houston, Texas, United States, 77030","Texas","United States","Research Site",{"$nulls":3},"MD","2018-11-05","2020-05-25T16:35:29.327","2020-05-26T17:10:42.972","NCT03392064"]
["5ecbf3d1e2561b1b11905cc0","NCT03392064","2019-03-15","Amgen","AMGN","Recruiting","A Phase 1 Study Evaluating the Safety, Tolerability and Efficacy of AMG 119 in Subjects With RR SCLC","Amg-119","CAR-T","Yes","['Amg-119']","Yes","['CAR-T']","Phase 1",1,41,"Anticipated","2018-09-10","2020-08-30","DLT","Dose Limiting Toxicity",{"$nulls":3},"A study to evaluate the safety and tolerability of AMG 119 in adult subjects with Relapsed/Refractory Small Cell Lung Cancer (SCLC) and determine the appropriate cell dose.","This is a phase 1, first-in-human study to evaluate the safety and tolerability of AMG 119, an investigational, Chimeric Antigen Receptor T cell therapy targeting delta-like protein 3 (DLL3) in subjects with relapsed/refractory small cell lung cancer who progressed after at least 1 platinum based chemotherapy regimen.","A Phase 1 Study Evaluating the Safety, Tolerability and Efficacy of AMG 119 in Subjects With Relapsed/Refractory Small Cell Lung Cancer",20170124,"Small Cell Lung Cancer","Lung Cancer|Small Cell Lung Cancer","Oncology Solid Tumor","Oncology","Experimental","AMG 119 Treatment","AMG 119 administered as a one-time intravenous infusion at different cell dose levels","Biological","AMG 119","Investigational, adoptive cellular immunotherapy for the treatment of small cell lung cancer",null,"AMG 119 Treatment","\n\n * Subject has provided informed consent prior to initiation of any study-specific activities/procedures;\n * Age â‰¥ 18 years old at the time of signing the informed consent\n * Histologically confirmed Small Cell Lung Cancer (SCLC) with radiographically documented disease progression or recurrence after at least one platinum-based regimen:\n * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1\n * At least 2 measurable lesions as defined per modified RECIST 1.1 by CT or MRI performed after the last line of anti-cancer therapy within 28 days of enrollment\n * Subjects with treated brain metastases are eligible provided they meet the following criteria:\n * - Definitive therapy was completed at least 2 weeks prior to enrollment.\n * - No evidence of radiographic CNS progression or CNS disease following definitive therapy and by the time of study screening. Patients manifesting progression in lesions previously treated with stereotactic radiosurgery may still be eligible if pseudoprogression can be demonstrated by appropriate means and after discussion with the medical monitor.\n * - Any CNS disease is asymptomatic, any neurologic symptoms due to CNS disease have returned to baseline or are deemed irreversible, the patient is off steroids for at least 7 days (physiologic doses of steroids are permitted), and the patient is off or on stable doses of anti-epileptic drugs for malignant CNS disease.\n * Adequate organ function\n * Other inclusion criteria may apply\n\n","\n\n * History of other malignancy within the past 2 years prior to enrollment except: Malignancy (other than in situ) treated with curative intent and with no known active disease present for â‰¥ 2 years before enrollment and felt to be at low risk for recurrence by the treating physician; Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease; Adequately treated in situ cancer without evidence of disease; Prostatic intraepithelial neoplasia without evidence of prostate cancer; Adequately treated urothelial papillary noninvasive carcinoma.\n * History of organ transplant.\n * Major surgery within 28 days of enrollment.\n * Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association > class II) within 12 months of enrollment.\n * History of arterial thrombosis (eg, stroke or transient ischemic attack) within 12 months of enrollment.\n * Untreated or symptomatic brain metastases and leptomeningeal disease\n * Presence of fungal, bacterial, viral, or other infection requiring IV antimicrobials for management within 7 days of enrollment. Note: Simple UTI and uncomplicated bacterial pharyngitis are permitted if responding to active treatment and after consultation with sponsor.\n * Subject has known sensitivity and immediate hypersensitivity to any components of AMG 119 or conditioning regimen (cyclophosphamide and fludarabine).\n * Evidence of a bleeding diathesis.\n * Systemic corticosteroid therapy within 7 days before enrollment. Note: Topical and inhaled corticosteroids in standard doses and physiologic replacement for subjects with adrenal insufficiency are allowed. â‰¥ 5 mg/day of prednisone or equivalent doses of other corticosteroids are not allowed.\n * Prior anti-cancer therapy as specified below: At least 28 days from enrollment must have elapsed from any prior systemic inhibitory/stimulatory immune checkpoint molecule therapy (eg, ipilimumab, nivolumab, pembrolizumab, atezolizumab, OX40 agonists, 4-1BB agonists, etc). Note: Patients who experienced immune -related pneumonitis, pituitary or thyroid dysfunction, or pancreatitis while on treatment with immune-oncology agents will be excluded; Other anti-cancer therapy (chemotherapy, antibody therapy, molecular targeted therapy, or investigational agent) within 14 days prior to enrollment; Radiation therapy completed within 14 days prior to enrollment; Prior CAR T therapy or other genetically modified T cell therapy.\n * Primary immunodeficiency\n * History of autoimmune disease resulting in end organ injury or requiring systemic immunosuppression/systemic disease modifying agents within the last 2 years prior to enrollment\n * Unresolved toxicities from prior anti-tumor therapy (defined as not having resolved to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 grade 1, or to levels dictated in the eligibility criteria) with the exception of alopecia or toxicities from prior anti-tumor therapy that are considered irreversible [defined as having been present and stable for > 28 days] which may be allowed if they are not otherwise described in the exclusion criteria AND there is agreement to allow by both the investigator and Amgen\n * Received live vaccine within 28 days prior to enrollment\n * Exclusion of hepatitis infection based on the following results and/or criteria: Positive for hepatitis B surface antigen (HBsAg) (indicative of chronic hepatitis B or recent acute hepatitis B); Negative HBsAg and positive for hepatitis B core antibody: hepatitis B virus DNA by polymerase chain reaction (PCR) is necessary. Detectable hepatitis B virus DNA suggests occult hepatitis B\n * Positive Hepatitis C virus antibody (HCVAb): hepatitis C virus RNA by PCR is necessary. Detectable hepatitis C virus RNA suggests chronic hepatitis C\n * History or evidence of any other clinically significant disorder, condition or disease that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion\n * Other exclusion criteria may apply",{"$nulls":4},"Actual","2018-01-05","Actual","Anticipated","2020-08-30","Anticipated","2019-03-01","2018-01-02","2018-01-02","2019-03-13","No","AMG 119\nCART\nDLL3","Interventional","Treatment","Sequential Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No","Yes\nDe-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request",null,"URL: http://www.amgentrials.com [http://www.amgentrials.com] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: AmgenTrials clinical trials website",null,"Yes","No",{"$nulls":19},"Incidence of dose limiting toxicities (DLTs)|Incidence of treatment-emergent adverse events and treatment-related adverse events|Incidence of clinically significant changes in vital signs|Incidence of clinically significant changes in physical examinations|Incidence of clinically significant changes in clinical laboratory tests","Up to 5 years",null,"Objective Response (OR)|Duration of Response (DOR)|Progression-Free Survival (PFS)|1-year Overall Survival (1-year OS)|Overall Survival (OS)|Measurement of expansion and persistence of CAR T cells in peripheral blood post-infusion|Evidence of CAR T cells in tumor tissue post dose","Up to 5 years",null,"medinfo@amgen.com","Amgen Call Center","866-572-6436","Houston, Texas, United States, 77030","Texas","United States","Research Site",{"$nulls":3},"MD","2019-03-13","2020-05-25T16:35:29.436","2020-05-26T17:10:42.972","NCT03392064"]
["5ecbf3d1307e3d1b1f8d9c54","NCT03392064","2019-04-05","Amgen","AMGN","Recruiting","A Phase 1 Study Evaluating the Safety, Tolerability and Efficacy of AMG 119 in Subjects With RR SCLC","Amg-119","CAR-T","Yes","['Amg-119']","Yes","['CAR-T']","Phase 1",1,41,"Anticipated","2018-09-10","2020-08-30","DLT","Dose Limiting Toxicity",{"$nulls":3},"A study to evaluate the safety and tolerability of AMG 119 in adult subjects with Relapsed/Refractory Small Cell Lung Cancer (SCLC) and determine the appropriate cell dose.","This is a phase 1, first-in-human study to evaluate the safety and tolerability of AMG 119, an investigational, Chimeric Antigen Receptor T cell therapy targeting delta-like protein 3 (DLL3) in subjects with relapsed/refractory small cell lung cancer who progressed after at least 1 platinum based chemotherapy regimen.","A Phase 1 Study Evaluating the Safety, Tolerability and Efficacy of AMG 119 in Subjects With Relapsed/Refractory Small Cell Lung Cancer",20170124,"Small Cell Lung Cancer","Lung Cancer|Small Cell Lung Cancer","Oncology Solid Tumor","Oncology","Experimental","AMG 119 Treatment","AMG 119 administered as a one-time intravenous infusion at different cell dose levels","Biological","AMG 119","Investigational, adoptive cellular immunotherapy for the treatment of small cell lung cancer",null,"AMG 119 Treatment","\n\n * Subject has provided informed consent prior to initiation of any study-specific activities/procedures;\n * Age â‰¥ 18 years old at the time of signing the informed consent\n * Histologically confirmed Small Cell Lung Cancer (SCLC) with radiographically documented disease progression or recurrence after at least one platinum-based regimen:\n * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1\n * At least 2 measurable lesions as defined per modified RECIST 1.1 by CT or MRI performed after the last line of anti-cancer therapy within 28 days of enrollment\n * Subjects with treated brain metastases are eligible provided they meet the following criteria:\n * - Definitive therapy was completed at least 2 weeks prior to enrollment.\n * - No evidence of radiographic CNS progression or CNS disease following definitive therapy and by the time of study screening. Patients manifesting progression in lesions previously treated with stereotactic radiosurgery may still be eligible if pseudoprogression can be demonstrated by appropriate means and after discussion with the medical monitor.\n * - Any CNS disease is asymptomatic, any neurologic symptoms due to CNS disease have returned to baseline or are deemed irreversible, the patient is off steroids for at least 7 days (physiologic doses of steroids are permitted), and the patient is off or on stable doses of anti-epileptic drugs for malignant CNS disease.\n * Adequate organ function\n * Other inclusion criteria may apply\n\n","\n\n * History of other malignancy within the past 2 years prior to enrollment except: Malignancy (other than in situ) treated with curative intent and with no known active disease present for â‰¥ 2 years before enrollment and felt to be at low risk for recurrence by the treating physician; Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease; Adequately treated in situ cancer without evidence of disease; Prostatic intraepithelial neoplasia without evidence of prostate cancer; Adequately treated urothelial papillary noninvasive carcinoma.\n * History of organ transplant.\n * Major surgery within 28 days of enrollment.\n * Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association > class II) within 12 months of enrollment.\n * History of arterial thrombosis (eg, stroke or transient ischemic attack) within 12 months of enrollment.\n * Untreated or symptomatic brain metastases and leptomeningeal disease\n * Presence of fungal, bacterial, viral, or other infection requiring IV antimicrobials for management within 7 days of enrollment. Note: Simple UTI and uncomplicated bacterial pharyngitis are permitted if responding to active treatment and after consultation with sponsor.\n * Subject has known sensitivity and immediate hypersensitivity to any components of AMG 119 or conditioning regimen (cyclophosphamide and fludarabine).\n * Evidence of a bleeding diathesis.\n * Systemic corticosteroid therapy within 7 days before enrollment. Note: Topical and inhaled corticosteroids in standard doses and physiologic replacement for subjects with adrenal insufficiency are allowed. â‰¥ 5 mg/day of prednisone or equivalent doses of other corticosteroids are not allowed.\n * Prior anti-cancer therapy as specified below: At least 28 days from enrollment must have elapsed from any prior systemic inhibitory/stimulatory immune checkpoint molecule therapy (eg, ipilimumab, nivolumab, pembrolizumab, atezolizumab, OX40 agonists, 4-1BB agonists, etc). Note: Patients who experienced immune -related pneumonitis, pituitary or thyroid dysfunction, or pancreatitis while on treatment with immune-oncology agents will be excluded; Other anti-cancer therapy (chemotherapy, antibody therapy, molecular targeted therapy, or investigational agent) within 14 days prior to enrollment; Radiation therapy completed within 14 days prior to enrollment; Prior CAR T therapy or other genetically modified T cell therapy.\n * Primary immunodeficiency\n * History of autoimmune disease resulting in end organ injury or requiring systemic immunosuppression/systemic disease modifying agents within the last 2 years prior to enrollment\n * Unresolved toxicities from prior anti-tumor therapy (defined as not having resolved to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 grade 1, or to levels dictated in the eligibility criteria) with the exception of alopecia or toxicities from prior anti-tumor therapy that are considered irreversible [defined as having been present and stable for > 28 days] which may be allowed if they are not otherwise described in the exclusion criteria AND there is agreement to allow by both the investigator and Amgen\n * Received live vaccine within 28 days prior to enrollment\n * Exclusion of hepatitis infection based on the following results and/or criteria: Positive for hepatitis B surface antigen (HBsAg) (indicative of chronic hepatitis B or recent acute hepatitis B); Negative HBsAg and positive for hepatitis B core antibody: hepatitis B virus DNA by polymerase chain reaction (PCR) is necessary. Detectable hepatitis B virus DNA suggests occult hepatitis B\n * Positive Hepatitis C virus antibody (HCVAb): hepatitis C virus RNA by PCR is necessary. Detectable hepatitis C virus RNA suggests chronic hepatitis C\n * History or evidence of any other clinically significant disorder, condition or disease that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion\n * Other exclusion criteria may apply",{"$nulls":4},"Actual","2018-01-05","Actual","Anticipated","2020-08-30","Anticipated","2019-04-01","2018-01-02","2018-01-02","2019-04-03","No","AMG 119\nCART\nDLL3","Interventional","Treatment","Sequential Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No","Yes\nDe-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request",null,"URL: http://www.amgentrials.com [http://www.amgentrials.com] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: AmgenTrials clinical trials website",null,"Yes","No",{"$nulls":19},"Incidence of dose limiting toxicities (DLTs)|Incidence of treatment-emergent adverse events and treatment-related adverse events|Incidence of clinically significant changes in vital signs|Incidence of clinically significant changes in physical examinations|Incidence of clinically significant changes in clinical laboratory tests","Up to 5 years",null,"Objective Response (OR)|Duration of Response (DOR)|Progression-Free Survival (PFS)|1-year Overall Survival (1-year OS)|Overall Survival (OS)|Measurement of expansion and persistence of CAR T cells in peripheral blood post-infusion|Evidence of CAR T cells in tumor tissue post dose","Up to 5 years",null,"medinfo@amgen.com","Amgen Call Center","866-572-6436","Tampa, Florida, United States, 33612|Houston, Texas, United States, 77030","Florida|Texas","United States","Research Site",{"$nulls":3},"MD","2019-04-03","2020-05-25T16:35:29.395","2020-05-26T17:10:42.972","NCT03392064"]
["5ecbf3d111702c1b1b9169d8","NCT03392064","2019-06-25","Amgen","AMGN","Recruiting","A Phase 1 Study Evaluating the Safety, Tolerability and Efficacy of AMG 119 in Subjects With RR SCLC","Amg-119","CAR-T","Yes","['Amg-119']","Yes","['CAR-T']","Phase 1",1,41,"Anticipated","2018-09-10","2021-06-30","DLT","Dose Limiting Toxicity",{"$nulls":3},"A study to evaluate the safety and tolerability of AMG 119 in adult subjects with Relapsed/Refractory Small Cell Lung Cancer (SCLC) and determine the appropriate cell dose.","This is a phase 1, first-in-human study to evaluate the safety and tolerability of AMG 119, an investigational, Chimeric Antigen Receptor T cell therapy targeting delta-like protein 3 (DLL3) in subjects with relapsed/refractory small cell lung cancer who progressed after at least 1 platinum based chemotherapy regimen.","A Phase 1 Study Evaluating the Safety, Tolerability and Efficacy of AMG 119 in Subjects With Relapsed/Refractory Small Cell Lung Cancer",20170124,"Small Cell Lung Cancer","Lung Cancer|Small Cell Lung Cancer","Oncology Solid Tumor","Oncology","Experimental","AMG 119 Treatment","AMG 119 administered as a one-time intravenous infusion at different cell dose levels","Biological","AMG 119","Investigational, adoptive cellular immunotherapy for the treatment of small cell lung cancer",null,"AMG 119 Treatment","\n\n * Subject has provided informed consent prior to initiation of any study-specific activities/procedures;\n * Age â‰¥ 18 years old at the time of signing the informed consent\n * Histologically or cytologically confirmed Small Cell Lung Cancer (SCLC) with radiographically documented disease progression or recurrence after at least one platinum-based regimen:\n * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1\n * At least 2 measurable lesions as defined per modified RECIST 1.1 by CT or MRI performed after the last line of anti-cancer therapy within 28 days of enrollment. Subjects with 1 measurable lesion may be considered upon agreement with Sponsor\n * Subjects with treated brain metastases are eligible provided they meet the following criteria:\n * - Definitive therapy was completed at least 2 weeks prior to enrollment.\n * - No evidence of radiographic CNS progression or CNS disease following definitive therapy and by the time of study screening. Patients manifesting progression in lesions previously treated with stereotactic radiosurgery may still be eligible if pseudoprogression can be demonstrated by appropriate means and after discussion with the medical monitor.\n * - Any CNS disease is asymptomatic, any neurologic symptoms due to CNS disease have returned to baseline or are deemed irreversible, the patient is off steroids for at least 7 days (physiologic doses of steroids are permitted), and the patient is off or on stable doses of anti-epileptic drugs for malignant CNS disease.\n * Adequate organ function\n * Other inclusion criteria may apply\n\n","\n\n * History of other malignancy within the past 2 years prior to enrollment except: Malignancy (other than in situ) treated with curative intent and with no known active disease present for â‰¥ 2 years before enrollment and felt to be at low risk for recurrence by the treating physician; Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease; Adequately treated in situ cancer without evidence of disease; Prostatic intraepithelial neoplasia without evidence of prostate cancer; Adequately treated urothelial papillary noninvasive carcinoma.\n * History of organ transplant.\n * Major surgery within 28 days of enrollment.\n * Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association > class II) within 12 months of enrollment.\n * History of arterial thrombosis (eg, stroke or transient ischemic attack) within 12 months of enrollment.\n * Untreated or symptomatic brain metastases and leptomeningeal disease\n * Presence of fungal, bacterial, viral, or other infection requiring IV antimicrobials for management within 7 days of enrollment. Note: Simple UTI and uncomplicated bacterial pharyngitis are permitted if responding to active treatment and after consultation with sponsor.\n * Subject has known sensitivity and immediate hypersensitivity to any components of AMG 119 or conditioning regimen (cyclophosphamide and fludarabine).\n * Evidence of a bleeding diathesis.\n * Systemic corticosteroid therapy within 7 days before enrollment. Note: Topical and inhaled corticosteroids in standard doses and physiologic replacement for subjects with adrenal insufficiency are allowed. â‰¥ 5 mg/day of prednisone or equivalent doses of other corticosteroids are not allowed.\n * Prior anti-cancer therapy as specified below: At least 28 days from enrollment must have elapsed from any prior systemic inhibitory/stimulatory immune checkpoint molecule therapy (eg, ipilimumab, nivolumab, pembrolizumab, atezolizumab, OX40 agonists, 4-1BB agonists, etc). Note: Patients who experienced immune -related pneumonitis, pituitary or thyroid dysfunction, or pancreatitis while on treatment with immune-oncology agents will be excluded; Other anti-cancer therapy (chemotherapy, antibody therapy, molecular targeted therapy, or investigational agent) within 14 days prior to enrollment; Radiation therapy completed within 14 days prior to enrollment; Prior CAR T therapy or other genetically modified T cell therapy.\n * Primary immunodeficiency\n * History of autoimmune disease resulting in end organ injury or requiring systemic immunosuppression/systemic disease modifying agents within the last 2 years prior to enrollment\n * Unresolved toxicities from prior anti-tumor therapy (defined as not having resolved to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 grade 1, or to levels dictated in the eligibility criteria) with the exception of alopecia or toxicities from prior anti-tumor therapy that are considered irreversible [defined as having been present and stable for > 28 days] which may be allowed if they are not otherwise described in the exclusion criteria AND there is agreement to allow by both the investigator and Amgen\n * Received live vaccine within 28 days prior to enrollment\n * Exclusion of hepatitis infection based on the following results and/or criteria: Positive for hepatitis B surface antigen (HBsAg) (indicative of chronic hepatitis B or recent acute hepatitis B); Negative HBsAg and positive for hepatitis B core antibody: hepatitis B virus DNA by polymerase chain reaction (PCR) is necessary. Detectable hepatitis B virus DNA suggests occult hepatitis B\n * Positive Hepatitis C virus antibody (HCVAb): hepatitis C virus RNA by PCR is necessary. Detectable hepatitis C virus RNA suggests chronic hepatitis C\n * History or evidence of any other clinically significant disorder, condition or disease that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion\n * Other exclusion criteria may apply",{"$nulls":4},"Actual","2018-01-05","Actual","Anticipated","2021-06-30","Anticipated","2019-06-01","2018-01-02","2018-01-02","2019-06-24","No","AMG 119\nCART\nDLL3","Interventional","Treatment","Sequential Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No","Yes\nDe-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request",null,"URL: http://www.amgentrials.com [http://www.amgentrials.com] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: AmgenTrials clinical trials website",null,"Yes","No",{"$nulls":19},"Incidence of dose limiting toxicities (DLTs)|Incidence of treatment-emergent adverse events and treatment-related adverse events|Incidence of clinically significant changes in vital signs|Incidence of clinically significant changes in physical examinations|Incidence of clinically significant changes in clinical laboratory tests","Up to 5 years",null,"Objective Response (OR)|Duration of Response (DOR)|Progression-Free Survival (PFS)|1-year Overall Survival (1-year OS)|Overall Survival (OS)|Measurement of expansion and persistence of CAR T cells in peripheral blood post-infusion|Evidence of CAR T cells in tumor tissue post dose","Up to 5 years",null,"medinfo@amgen.com","Amgen Call Center","866-572-6436","Tampa, Florida, United States, 33612|Houston, Texas, United States, 77030","Florida|Texas","United States","Research Site",{"$nulls":3},"MD","2019-06-24","2020-05-25T16:35:29.802","2020-05-26T17:10:42.972","NCT03392064"]
["5ecbf3d1307e3d1b1f8d9c55","NCT03392064","2019-07-12","Amgen","AMGN","Active, not recruiting","A Phase 1 Study Evaluating the Safety, Tolerability and Efficacy of AMG 119 in Subjects With RR SCLC","Amg-119","CAR-T","Yes","['Amg-119']","Yes","['CAR-T']","Phase 1",1,6,"Actual","2018-09-10","2021-06-30","DLT","Dose Limiting Toxicity",{"$nulls":3},"A study to evaluate the safety and tolerability of AMG 119 in adult subjects with Relapsed/Refractory Small Cell Lung Cancer (SCLC) and determine the appropriate cell dose.","This is a phase 1, first-in-human study to evaluate the safety and tolerability of AMG 119, an investigational, Chimeric Antigen Receptor T cell therapy targeting delta-like protein 3 (DLL3) in subjects with relapsed/refractory small cell lung cancer who progressed after at least 1 platinum based chemotherapy regimen.","A Phase 1 Study Evaluating the Safety, Tolerability and Efficacy of AMG 119 in Subjects With Relapsed/Refractory Small Cell Lung Cancer",20170124,"Small Cell Lung Cancer","Lung Cancer|Small Cell Lung Cancer","Oncology Solid Tumor","Oncology","Experimental","AMG 119 Treatment","AMG 119 administered as a one-time intravenous infusion at different cell dose levels","Biological","AMG 119","Investigational, adoptive cellular immunotherapy for the treatment of small cell lung cancer",null,"AMG 119 Treatment","\n\n * Subject has provided informed consent prior to initiation of any study-specific activities/procedures;\n * Age â‰¥ 18 years old at the time of signing the informed consent\n * Histologically or cytologically confirmed Small Cell Lung Cancer (SCLC) with radiographically documented disease progression or recurrence after at least one platinum-based regimen:\n * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1\n * At least 2 measurable lesions as defined per modified RECIST 1.1 by CT or MRI performed after the last line of anti-cancer therapy within 28 days of enrollment. Subjects with 1 measurable lesion may be considered upon agreement with Sponsor\n * Subjects with treated brain metastases are eligible provided they meet the following criteria:\n * - Definitive therapy was completed at least 2 weeks prior to enrollment.\n * - No evidence of radiographic CNS progression or CNS disease following definitive therapy and by the time of study screening. Patients manifesting progression in lesions previously treated with stereotactic radiosurgery may still be eligible if pseudoprogression can be demonstrated by appropriate means and after discussion with the medical monitor.\n * - Any CNS disease is asymptomatic, any neurologic symptoms due to CNS disease have returned to baseline or are deemed irreversible, the patient is off steroids for at least 7 days (physiologic doses of steroids are permitted), and the patient is off or on stable doses of anti-epileptic drugs for malignant CNS disease.\n * Adequate organ function\n * Other inclusion criteria may apply\n\n","\n\n * History of other malignancy within the past 2 years prior to enrollment except: Malignancy (other than in situ) treated with curative intent and with no known active disease present for â‰¥ 2 years before enrollment and felt to be at low risk for recurrence by the treating physician; Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease; Adequately treated in situ cancer without evidence of disease; Prostatic intraepithelial neoplasia without evidence of prostate cancer; Adequately treated urothelial papillary noninvasive carcinoma.\n * History of organ transplant.\n * Major surgery within 28 days of enrollment.\n * Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association > class II) within 12 months of enrollment.\n * History of arterial thrombosis (eg, stroke or transient ischemic attack) within 12 months of enrollment.\n * Untreated or symptomatic brain metastases and leptomeningeal disease\n * Presence of fungal, bacterial, viral, or other infection requiring IV antimicrobials for management within 7 days of enrollment. Note: Simple UTI and uncomplicated bacterial pharyngitis are permitted if responding to active treatment and after consultation with sponsor.\n * Subject has known sensitivity and immediate hypersensitivity to any components of AMG 119 or conditioning regimen (cyclophosphamide and fludarabine).\n * Evidence of a bleeding diathesis.\n * Systemic corticosteroid therapy within 7 days before enrollment. Note: Topical and inhaled corticosteroids in standard doses and physiologic replacement for subjects with adrenal insufficiency are allowed. â‰¥ 5 mg/day of prednisone or equivalent doses of other corticosteroids are not allowed.\n * Prior anti-cancer therapy as specified below: At least 28 days from enrollment must have elapsed from any prior systemic inhibitory/stimulatory immune checkpoint molecule therapy (eg, ipilimumab, nivolumab, pembrolizumab, atezolizumab, OX40 agonists, 4-1BB agonists, etc). Note: Patients who experienced immune -related pneumonitis, pituitary or thyroid dysfunction, or pancreatitis while on treatment with immune-oncology agents will be excluded; Other anti-cancer therapy (chemotherapy, antibody therapy, molecular targeted therapy, or investigational agent) within 14 days prior to enrollment; Radiation therapy completed within 14 days prior to enrollment; Prior CAR T therapy or other genetically modified T cell therapy.\n * Primary immunodeficiency\n * History of autoimmune disease resulting in end organ injury or requiring systemic immunosuppression/systemic disease modifying agents within the last 2 years prior to enrollment\n * Unresolved toxicities from prior anti-tumor therapy (defined as not having resolved to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 grade 1, or to levels dictated in the eligibility criteria) with the exception of alopecia or toxicities from prior anti-tumor therapy that are considered irreversible [defined as having been present and stable for > 28 days] which may be allowed if they are not otherwise described in the exclusion criteria AND there is agreement to allow by both the investigator and Amgen\n * Received live vaccine within 28 days prior to enrollment\n * Exclusion of hepatitis infection based on the following results and/or criteria: Positive for hepatitis B surface antigen (HBsAg) (indicative of chronic hepatitis B or recent acute hepatitis B); Negative HBsAg and positive for hepatitis B core antibody: hepatitis B virus DNA by polymerase chain reaction (PCR) is necessary. Detectable hepatitis B virus DNA suggests occult hepatitis B\n * Positive Hepatitis C virus antibody (HCVAb): hepatitis C virus RNA by PCR is necessary. Detectable hepatitis C virus RNA suggests chronic hepatitis C\n * History or evidence of any other clinically significant disorder, condition or disease that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion\n * Other exclusion criteria may apply",{"$nulls":4},"Actual","2018-01-05","Actual","Anticipated","2021-06-30","Anticipated","2019-07-01","2018-01-02","2018-01-02","2019-07-10","No","AMG 119\nCART\nDLL3","Interventional","Treatment","Sequential Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No","Yes\nDe-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request",null,"URL: http://www.amgentrials.com [http://www.amgentrials.com] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: AmgenTrials clinical trials website",null,"Yes","No",{"$nulls":19},"Incidence of dose limiting toxicities (DLTs)|Incidence of treatment-emergent adverse events and treatment-related adverse events|Incidence of clinically significant changes in vital signs|Incidence of clinically significant changes in physical examinations|Incidence of clinically significant changes in clinical laboratory tests","Up to 5 years",null,"Objective Response (OR)|Duration of Response (DOR)|Progression-Free Survival (PFS)|1-year Overall Survival (1-year OS)|Overall Survival (OS)|Measurement of expansion and persistence of CAR T cells in peripheral blood post-infusion|Evidence of CAR T cells in tumor tissue post dose","Up to 5 years",{"$nulls":4},"Tampa, Florida, United States, 33612|Houston, Texas, United States, 77030","Florida|Texas","United States","Research Site",{"$nulls":3},"MD","2019-07-10","2020-05-25T16:35:29.573","2020-05-26T17:10:42.972","NCT03392064"]
["5ecbf3d2fe30261b1a0481c5","NCT03392064","2019-09-06","Amgen","AMGN","Active, not recruiting","A Phase 1 Study Evaluating the Safety, Tolerability and Efficacy of AMG 119 in Subjects With RR SCLC","Amg-119","CAR-T","Yes","['Amg-119']","Yes","['CAR-T']","Phase 1",1,6,"Actual","2018-09-10","2021-06-30","DLT","Dose Limiting Toxicity",{"$nulls":3},"A study to evaluate the safety and tolerability of AMG 119 in adult subjects with Relapsed/Refractory Small Cell Lung Cancer (SCLC) and determine the appropriate cell dose.","This is a phase 1, first-in-human study to evaluate the safety and tolerability of AMG 119, an investigational, Chimeric Antigen Receptor T cell therapy targeting delta-like protein 3 (DLL3) in subjects with relapsed/refractory small cell lung cancer who progressed after at least 1 platinum based chemotherapy regimen.","A Phase 1 Study Evaluating the Safety, Tolerability and Efficacy of AMG 119 in Subjects With Relapsed/Refractory Small Cell Lung Cancer",20170124,"Small Cell Lung Cancer","Lung Cancer|Small Cell Lung Cancer","Oncology Solid Tumor","Oncology","Experimental","AMG 119 Treatment","AMG 119 administered as a one-time intravenous infusion at different cell dose levels","Biological","AMG 119","Investigational, adoptive cellular immunotherapy for the treatment of small cell lung cancer",null,"AMG 119 Treatment","\n\n * Subject has provided informed consent prior to initiation of any study-specific activities/procedures;\n * Age â‰¥ 18 years old at the time of signing the informed consent\n * Histologically or cytologically confirmed Small Cell Lung Cancer (SCLC) with radiographically documented disease progression or recurrence after at least one platinum-based regimen:\n * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1\n * At least 2 measurable lesions as defined per modified RECIST 1.1 by CT or MRI performed after the last line of anti-cancer therapy within 28 days of enrollment. Subjects with 1 measurable lesion may be considered upon agreement with Sponsor\n * Subjects with treated brain metastases are eligible provided they meet the following criteria:\n * - Definitive therapy was completed at least 2 weeks prior to enrollment.\n * - No evidence of radiographic CNS progression or CNS disease following definitive therapy and by the time of study screening. Patients manifesting progression in lesions previously treated with stereotactic radiosurgery may still be eligible if pseudoprogression can be demonstrated by appropriate means and after discussion with the medical monitor.\n * - Any CNS disease is asymptomatic, any neurologic symptoms due to CNS disease have returned to baseline or are deemed irreversible, the patient is off steroids for at least 7 days (physiologic doses of steroids are permitted), and the patient is off or on stable doses of anti-epileptic drugs for malignant CNS disease for at least 7 days.\n * Adequate organ function\n * Other inclusion criteria may apply\n\n","\n\n * History of other malignancy within the past 2 years prior to enrollment except: Malignancy (other than in situ) treated with curative intent and with no known active disease present for â‰¥ 2 years before enrollment and felt to be at low risk for recurrence by the treating physician; Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease; Adequately treated in situ cancer without evidence of disease; Prostatic intraepithelial neoplasia without evidence of prostate cancer; Adequately treated urothelial papillary noninvasive carcinoma.\n * History of organ transplant.\n * Major surgery within 28 days of enrollment.\n * Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association > class II) within 12 months of enrollment.\n * History of arterial thrombosis (eg, stroke or transient ischemic attack) within 12 months of enrollment.\n * Untreated or symptomatic brain metastases and leptomeningeal disease\n * Presence of fungal, bacterial, viral, or other infection requiring IV antimicrobials for management within 7 days of enrollment. Note: Simple UTI and uncomplicated bacterial pharyngitis are permitted if responding to active treatment and after consultation with sponsor.\n * Known sensitivity and immediate hypersensitivity to any components of AMG 119 or conditioning regimen (cyclophosphamide and fludarabine).\n * Evidence of a bleeding diathesis.\n * Systemic corticosteroid therapy within 7 days before enrollment. Note: Topical and inhaled corticosteroids in standard doses and physiologic replacement for subjects with adrenal insufficiency are allowed. â‰¥ 5 mg/day of prednisone or equivalent doses of other corticosteroids are not allowed.\n * Prior anti-cancer therapy as specified below: At least 21 days from enrollment must have elapsed from any prior systemic inhibitory/stimulatory immune checkpoint molecule therapy (eg, ipilimumab, nivolumab, pembrolizumab, atezolizumab, OX40 agonists, 4-1BB agonists, etc). Note: Patients who experienced immune -related pneumonitis, pituitary or thyroid dysfunction, or pancreatitis while on treatment with immune-oncology agents will be excluded; Other anti-cancer therapy (chemotherapy, antibody therapy, molecular targeted therapy, or investigational agent) within 14 days prior to enrollment; Radiation therapy completed within 14 days prior to enrollment; Prior CAR T therapy or other genetically modified T cell therapy with the exception of subjects who received AMG 119 in this study and are eligible for retreatment.\n * Primary immunodeficiency\n * History of autoimmune disease resulting in end organ injury or requiring systemic immunosuppression/systemic disease modifying agents within the last 2 years prior to enrollment\n * Unresolved toxicities from prior anti-tumor therapy (defined as not having resolved to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 grade 1, or to levels dictated in the eligibility criteria) with the exception of alopecia or toxicities from prior anti-tumor therapy that are considered irreversible [defined as having been present and stable for > 28 days] which may be allowed if they are not otherwise described in the exclusion criteria AND there is agreement to allow by both the investigator and Amgen\n * Received live vaccine within 28 days prior to enrollment\n * Exclusion of hepatitis infection based on the following results and/or criteria: Positive for hepatitis B surface antigen (HBsAg) (indicative of chronic hepatitis B or recent acute hepatitis B); Negative HBsAg and positive for hepatitis B core antibody: hepatitis B virus DNA by polymerase chain reaction (PCR) is necessary. Detectable hepatitis B virus DNA suggests occult hepatitis B\n * Positive Hepatitis C virus antibody (HCVAb): hepatitis C virus RNA by PCR is necessary. Detectable hepatitis C virus RNA suggests chronic hepatitis C\n * History or evidence of any other clinically significant disorder, condition or disease that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion\n * Other exclusion criteria may apply",{"$nulls":4},"Actual","2018-01-05","Actual","Anticipated","2021-06-30","Anticipated","2019-08-01","2018-01-02","2018-01-02","2019-09-05","No","AMG 119\nCART\nDLL3","Interventional","Treatment","Sequential Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No","Yes\nDe-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request",null,"URL: http://www.amgentrials.com [http://www.amgentrials.com] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: AmgenTrials clinical trials website",null,"Yes","No",{"$nulls":19},"Incidence of dose limiting toxicities (DLTs)|Incidence of treatment-emergent adverse events and treatment-related adverse events|Incidence of clinically significant changes in vital signs|Incidence of clinically significant changes in physical examinations|Incidence of clinically significant changes in clinical laboratory tests","Up to 5 years",null,"Objective Response (OR)|Duration of Response (DOR)|Progression-Free Survival (PFS)|1-year Overall Survival (1-year OS)|Overall Survival (OS)|Measurement of expansion and persistence of CAR T cells in peripheral blood post-infusion|Evidence of CAR T cells in tumor tissue post dose","Up to 5 years",{"$nulls":4},"Tampa, Florida, United States, 33612|Houston, Texas, United States, 77030","Florida|Texas","United States","Research Site",{"$nulls":3},"MD","2019-09-05","2020-05-25T16:35:30.004","2020-05-26T17:10:42.972","NCT03392064"]
["5ecbf3d1feab101b155307f4","NCT03392064","2019-11-22","Amgen","AMGN","Active, not recruiting","A Phase 1 Study Evaluating the Safety, Tolerability and Efficacy of AMG 119 in Subjects With RR SCLC","Amg-119","CAR-T","Yes","['Amg-119']","Yes","['CAR-T']","Phase 1",1,6,"Actual","2018-09-10","2020-03-10","DLT","Dose Limiting Toxicity",{"$nulls":3},"A study to evaluate the safety and tolerability of AMG 119 in adult subjects with Relapsed/Refractory Small Cell Lung Cancer (SCLC) and determine the appropriate cell dose.","This is a phase 1, first-in-human study to evaluate the safety and tolerability of AMG 119, an investigational, Chimeric Antigen Receptor T cell therapy targeting delta-like protein 3 (DLL3) in subjects with relapsed/refractory small cell lung cancer who progressed after at least 1 platinum based chemotherapy regimen.","A Phase 1 Study Evaluating the Safety, Tolerability and Efficacy of AMG 119 in Subjects With Relapsed/Refractory Small Cell Lung Cancer",20170124,"Small Cell Lung Cancer","Lung Cancer|Small Cell Lung Cancer","Oncology Solid Tumor","Oncology","Experimental","AMG 119 Treatment","AMG 119 administered as a one-time intravenous infusion at different cell dose levels","Biological","AMG 119","Investigational, adoptive cellular immunotherapy for the treatment of small cell lung cancer",null,"AMG 119 Treatment","\n\n * Subject has provided informed consent prior to initiation of any study-specific activities/procedures;\n * Age â‰¥ 18 years old at the time of signing the informed consent\n * Histologically or cytologically confirmed Small Cell Lung Cancer (SCLC) with radiographically documented disease progression or recurrence after at least one platinum-based regimen:\n * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1\n * At least 2 measurable lesions as defined per modified RECIST 1.1 by CT or MRI performed after the last line of anti-cancer therapy within 28 days of enrollment. Subjects with 1 measurable lesion may be considered upon agreement with Sponsor\n * Subjects with treated brain metastases are eligible provided they meet the following criteria:\n * - Definitive therapy was completed at least 2 weeks prior to enrollment.\n * - No evidence of radiographic CNS progression or CNS disease following definitive therapy and by the time of study screening. Patients manifesting progression in lesions previously treated with stereotactic radiosurgery may still be eligible if pseudoprogression can be demonstrated by appropriate means and after discussion with the medical monitor.\n * - Any CNS disease is asymptomatic, any neurologic symptoms due to CNS disease have returned to baseline or are deemed irreversible, the patient is off steroids for at least 7 days (physiologic doses of steroids are permitted), and the patient is off or on stable doses of anti-epileptic drugs for malignant CNS disease for at least 7 days.\n * Adequate organ function\n * Other inclusion criteria may apply\n\n","\n\n * History of other malignancy within the past 2 years prior to enrollment except: Malignancy (other than in situ) treated with curative intent and with no known active disease present for â‰¥ 2 years before enrollment and felt to be at low risk for recurrence by the treating physician; Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease; Adequately treated in situ cancer without evidence of disease; Prostatic intraepithelial neoplasia without evidence of prostate cancer; Adequately treated urothelial papillary noninvasive carcinoma.\n * History of organ transplant.\n * Major surgery within 28 days of enrollment.\n * Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association > class II) within 12 months of enrollment.\n * History of arterial thrombosis (eg, stroke or transient ischemic attack) within 12 months of enrollment.\n * Untreated or symptomatic brain metastases and leptomeningeal disease\n * Presence of fungal, bacterial, viral, or other infection requiring IV antimicrobials for management within 7 days of enrollment. Note: Simple UTI and uncomplicated bacterial pharyngitis are permitted if responding to active treatment and after consultation with sponsor.\n * Known sensitivity and immediate hypersensitivity to any components of AMG 119 or conditioning regimen (cyclophosphamide and fludarabine).\n * Evidence of a bleeding diathesis.\n * Systemic corticosteroid therapy within 7 days before enrollment. Note: Topical and inhaled corticosteroids in standard doses and physiologic replacement for subjects with adrenal insufficiency are allowed. â‰¥ 5 mg/day of prednisone or equivalent doses of other corticosteroids are not allowed.\n * Prior anti-cancer therapy as specified below: At least 21 days from enrollment must have elapsed from any prior systemic inhibitory/stimulatory immune checkpoint molecule therapy (eg, ipilimumab, nivolumab, pembrolizumab, atezolizumab, OX40 agonists, 4-1BB agonists, etc). Note: Patients who experienced immune -related pneumonitis, pituitary or thyroid dysfunction, or pancreatitis while on treatment with immune-oncology agents will be excluded; Other anti-cancer therapy (chemotherapy, antibody therapy, molecular targeted therapy, or investigational agent) within 14 days prior to enrollment; Radiation therapy completed within 14 days prior to enrollment; Prior CAR T therapy or other genetically modified T cell therapy with the exception of subjects who received AMG 119 in this study and are eligible for retreatment.\n * Primary immunodeficiency\n * History of autoimmune disease resulting in end organ injury or requiring systemic immunosuppression/systemic disease modifying agents within the last 2 years prior to enrollment\n * Unresolved toxicities from prior anti-tumor therapy (defined as not having resolved to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 grade 1, or to levels dictated in the eligibility criteria) with the exception of alopecia or toxicities from prior anti-tumor therapy that are considered irreversible [defined as having been present and stable for > 28 days] which may be allowed if they are not otherwise described in the exclusion criteria AND there is agreement to allow by both the investigator and Amgen\n * Received live vaccine within 28 days prior to enrollment\n * Exclusion of hepatitis infection based on the following results and/or criteria: Positive for hepatitis B surface antigen (HBsAg) (indicative of chronic hepatitis B or recent acute hepatitis B); Negative HBsAg and positive for hepatitis B core antibody: hepatitis B virus DNA by polymerase chain reaction (PCR) is necessary. Detectable hepatitis B virus DNA suggests occult hepatitis B\n * Positive Hepatitis C virus antibody (HCVAb): hepatitis C virus RNA by PCR is necessary. Detectable hepatitis C virus RNA suggests chronic hepatitis C\n * History or evidence of any other clinically significant disorder, condition or disease that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion\n * Other exclusion criteria may apply",{"$nulls":4},"Actual","2018-01-05","Actual","Anticipated","2020-03-10","Anticipated","2019-11-01","2018-01-02","2018-01-02","2019-11-21","No","AMG 119\nCART\nDLL3","Interventional","Treatment","Sequential Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No","Yes\nDe-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request",null,"URL: http://www.amgentrials.com [http://www.amgentrials.com] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: AmgenTrials clinical trials website",null,"Yes","No",{"$nulls":19},"Incidence of dose limiting toxicities (DLTs)|Incidence of treatment-emergent adverse events and treatment-related adverse events|Incidence of clinically significant changes in vital signs|Incidence of clinically significant changes in physical examinations|Incidence of clinically significant changes in clinical laboratory tests","Up to 5 years",null,"Objective Response (OR)|Duration of Response (DOR)|Progression-Free Survival (PFS)|1-year Overall Survival (1-year OS)|Overall Survival (OS)|Measurement of expansion and persistence of CAR T cells in peripheral blood post-infusion|Evidence of CAR T cells in tumor tissue post dose","Up to 5 years",{"$nulls":4},"Tampa, Florida, United States, 33612|Houston, Texas, United States, 77030","Florida|Texas","United States","Research Site",{"$nulls":3},"MD","2019-11-21","2020-05-25T16:35:29.584","2020-05-26T17:10:42.972","NCT03392064"]
["5ecbf3d2e2561b1b11905cc1","NCT03392064","2020-02-17","Amgen","AMGN","Active, not recruiting","A Phase 1 Study Evaluating the Safety, Tolerability and Efficacy of AMG 119 in Subjects With RR SCLC","Amg-119","CAR-T","Yes","['Amg-119']","Yes","['CAR-T']","Phase 1",1,6,"Actual","2018-09-10","2025-01-13","DLT","Dose Limiting Toxicity",{"$nulls":3},"A study to evaluate the safety and tolerability of AMG 119 in adult subjects with Relapsed/Refractory Small Cell Lung Cancer (SCLC) and determine the appropriate cell dose.","This is a phase 1, first-in-human study to evaluate the safety and tolerability of AMG 119, an investigational, Chimeric Antigen Receptor T cell therapy targeting delta-like protein 3 (DLL3) in subjects with relapsed/refractory small cell lung cancer who progressed after at least 1 platinum based chemotherapy regimen.","A Phase 1 Study Evaluating the Safety, Tolerability and Efficacy of AMG 119 in Subjects With Relapsed/Refractory Small Cell Lung Cancer",20170124,"Small Cell Lung Cancer","Lung Cancer|Small Cell Lung Cancer","Oncology Solid Tumor","Oncology","Experimental","AMG 119 Treatment","AMG 119 administered as a one-time intravenous infusion at different cell dose levels","Biological","AMG 119","Investigational, adoptive cellular immunotherapy for the treatment of small cell lung cancer",null,"AMG 119 Treatment","\n\n * Subject has provided informed consent prior to initiation of any study-specific activities/procedures;\n * Age â‰¥ 18 years old at the time of signing the informed consent\n * Histologically or cytologically confirmed Small Cell Lung Cancer (SCLC) with radiographically documented disease progression or recurrence after at least one platinum-based regimen:\n * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1\n * At least 2 measurable lesions as defined per modified RECIST 1.1 by CT or MRI performed after the last line of anti-cancer therapy within 28 days of enrollment. Subjects with 1 measurable lesion may be considered upon agreement with Sponsor\n * Subjects with treated brain metastases are eligible provided they meet the following criteria:\n * - Definitive therapy was completed at least 2 weeks prior to enrollment.\n * - No evidence of radiographic CNS progression or CNS disease following definitive therapy and by the time of study screening. Patients manifesting progression in lesions previously treated with stereotactic radiosurgery may still be eligible if pseudoprogression can be demonstrated by appropriate means and after discussion with the medical monitor.\n * - Any CNS disease is asymptomatic, any neurologic symptoms due to CNS disease have returned to baseline or are deemed irreversible, the patient is off steroids for at least 7 days (physiologic doses of steroids are permitted), and the patient is off or on stable doses of anti-epileptic drugs for malignant CNS disease for at least 7 days.\n * Adequate organ function\n * Other inclusion criteria may apply\n\n","\n\n * History of other malignancy within the past 2 years prior to enrollment except: Malignancy (other than in situ) treated with curative intent and with no known active disease present for â‰¥ 2 years before enrollment and felt to be at low risk for recurrence by the treating physician; Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease; Adequately treated in situ cancer without evidence of disease; Prostatic intraepithelial neoplasia without evidence of prostate cancer; Adequately treated urothelial papillary noninvasive carcinoma.\n * History of organ transplant.\n * Major surgery within 28 days of enrollment.\n * Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association > class II) within 12 months of enrollment.\n * History of arterial thrombosis (eg, stroke or transient ischemic attack) within 12 months of enrollment.\n * Untreated or symptomatic brain metastases and leptomeningeal disease\n * Presence of fungal, bacterial, viral, or other infection requiring IV antimicrobials for management within 7 days of enrollment. Note: Simple UTI and uncomplicated bacterial pharyngitis are permitted if responding to active treatment and after consultation with sponsor.\n * Known sensitivity and immediate hypersensitivity to any components of AMG 119 or conditioning regimen (cyclophosphamide and fludarabine).\n * Evidence of a bleeding diathesis.\n * Systemic corticosteroid therapy within 7 days before enrollment. Note: Topical and inhaled corticosteroids in standard doses and physiologic replacement for subjects with adrenal insufficiency are allowed. â‰¥ 5 mg/day of prednisone or equivalent doses of other corticosteroids are not allowed.\n * Prior anti-cancer therapy as specified below: At least 21 days from enrollment must have elapsed from any prior systemic inhibitory/stimulatory immune checkpoint molecule therapy (eg, ipilimumab, nivolumab, pembrolizumab, atezolizumab, OX40 agonists, 4-1BB agonists, etc). Note: Patients who experienced immune -related pneumonitis, pituitary or thyroid dysfunction, or pancreatitis while on treatment with immune-oncology agents will be excluded; Other anti-cancer therapy (chemotherapy, antibody therapy, molecular targeted therapy, or investigational agent) within 14 days prior to enrollment; Radiation therapy completed within 14 days prior to enrollment; Prior CAR T therapy or other genetically modified T cell therapy with the exception of subjects who received AMG 119 in this study and are eligible for retreatment.\n * Primary immunodeficiency\n * History of autoimmune disease resulting in end organ injury or requiring systemic immunosuppression/systemic disease modifying agents within the last 2 years prior to enrollment\n * Unresolved toxicities from prior anti-tumor therapy (defined as not having resolved to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 grade 1, or to levels dictated in the eligibility criteria) with the exception of alopecia or toxicities from prior anti-tumor therapy that are considered irreversible [defined as having been present and stable for > 28 days] which may be allowed if they are not otherwise described in the exclusion criteria AND there is agreement to allow by both the investigator and Amgen\n * Received live vaccine within 28 days prior to enrollment\n * Exclusion of hepatitis infection based on the following results and/or criteria: Positive for hepatitis B surface antigen (HBsAg) (indicative of chronic hepatitis B or recent acute hepatitis B); Negative HBsAg and positive for hepatitis B core antibody: hepatitis B virus DNA by polymerase chain reaction (PCR) is necessary. Detectable hepatitis B virus DNA suggests occult hepatitis B\n * Positive Hepatitis C virus antibody (HCVAb): hepatitis C virus RNA by PCR is necessary. Detectable hepatitis C virus RNA suggests chronic hepatitis C\n * History or evidence of any other clinically significant disorder, condition or disease that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion\n * Other exclusion criteria may apply",{"$nulls":4},"Actual","2018-01-05","Actual","Anticipated","2025-01-13","Anticipated","2020-02-01","2018-01-02","2018-01-02","2020-02-13","No","AMG 119\nCART\nDLL3","Interventional","Treatment","Sequential Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No","Yes\nDe-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request",null,"URL: http://www.amgentrials.com [http://www.amgentrials.com] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: AmgenTrials clinical trials website",null,"Yes","No",{"$nulls":19},"Incidence of dose limiting toxicities (DLTs)|Incidence of treatment-emergent adverse events and treatment-related adverse events|Incidence of clinically significant changes in vital signs|Incidence of clinically significant changes in physical examinations|Incidence of clinically significant changes in clinical laboratory tests","Up to 5 years",null,"Objective Response (OR)|Duration of Response (DOR)|Progression-Free Survival (PFS)|1-year Overall Survival (1-year OS)|Overall Survival (OS)|Measurement of expansion and persistence of CAR T cells in peripheral blood post-infusion|Evidence of CAR T cells in tumor tissue post dose","Up to 5 years",{"$nulls":4},"Tampa, Florida, United States, 33612|Houston, Texas, United States, 77030","Florida|Texas","United States","Research Site",{"$nulls":3},"MD","2020-02-13","2020-05-25T16:35:30.089","2020-05-26T17:10:42.972","NCT03392064"]
["5ecbf3d3fe30261b1a0481ca","NCT03392168","2018-01-05","Arcutis","ARQT","Recruiting","Safety, Pharmacokinetics and Efficacy of ARQ-151 Cream in Adults With Mild to Moderate Chronic Plaque Psoriasis","Arq-151",null,"Yes","['Arq-151']","Unknown",null,"Phase 1/Phase 2",4,92,"Anticipated","2017-12-11","2018-05-01",{"$nulls":5},"This study is designed to assess the safety and pharmacokinetics (PK) of a single dose application of ARQ-151 cream 0.5% to 25 cm2 of psoriatic plaque(s) (Cohort 1). The study will also assess the safety, PK and efficacy of different doses and multiple applications of ARQ-151 cream 0.5% vs placebo and ARQ-151 cream 0.15% vs placebo applied once a day for 28 days to individuals with 0.5% to 5.0% body surface area (BSA) of chronic plaque psoriasis (Cohort 2).","There are 2 cohorts of subjects. Cohort 1 is a single dose study of ARQ-151 0.5% cream applied to 25 cm2 of psoriatic plaque(s) in up to 8 psoriasis subjects. Cohort 2 is a parallel group, double blind, vehicle controlled study in which ARQ-151 cream 0.5%, ARQ-151 cream 0.15% or vehicle cream is applied once a day for 28 days to subjects with between 0.5% to 5.0% BSA of chronic plaque psoriasis. Including both Cohorts, a total of up to 92 subjects will be enrolled at 8 study sites in Canada and the US. Subjects will be adult (â‰¥18 years old) males or females with chronic plaque psoriasis.","A Phase 1/2a Single Dose and 28-day Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety, Pharmacokinetics and Efficacy of ARQ-151 Cream 0.5% and 0.15% in Adults With Mild to Moderate Chronic Plaque Psoriasis","ARQ-151-101","Psoriasis","Psoriasis","Dermatological Diseases","Derm & Connective Tissue Disorders","Experimental|Active Comparator|Placebo Comparator","Cohort 1 - PK and Safety|Cohort 2 - ARQ-151 cream 0.5%|Cohort 2 - ARQ-151 cream 0.15%|Cohort 2 - ARQ-151 cream placebo","Open Label ARQ-151 cream 0.5%|Blinded","Drug","ARQ-151 cream 0.5%|ARQ-151 cream 0.15%|ARQ-151 cream placebo","0.5% active concentration|0.15% active concentration|Cream vehicle",null,"Cohort 1 - PK and Safety|Cohort 2 - ARQ-151 cream 0.5%|Cohort 2 - ARQ-151 cream 0.15%|Cohort 2 - ARQ-151 cream placebo","\n\n * Adult male and female subjects aged â‰¥18 years\n * In Cohort 1, subjects must have at least 25 cm2 of chronic plaque psoriasis (excluding the face, scalp, intertriginous areas, palms and soles).\n * In Cohort 2, subjects must have 0.5% to 5.0% of total BSA of chronic plaque psoriasis and at least one target plaque, of at least 9 cm2 in size with a TPSS â‰¥4 (excluding the face, scalp, intertriginous areas, palms and soles).\n * Women of childbearing potential must have a negative urine pregnancy test at Screening and agree to use birth control throughout the trial.\n * In good health as judged by the Investigator, based on medical history, physical examination, 12-lead electrocardiogram (ECG), serum chemistry labs, hematology values, and urinalysis.\n * Subjects agree not to have prolonged sun exposure during the course of the study. Tanning bed use is not allowed.\n * Subjects are competent to sign and give informed consent and considered reliable and capable of adhering to the Protocol and visit schedule.\n\n","\n\n * Subjects with non-plaque forms of psoriasis (erythrodermic, guttate, pustular or palmo-plantar psoriasis) or with drug-induced psoriasis\n * Evidence of skin conditions other than psoriasis that would interfere with evaluation of the effect of the study medication.\n * Pregnant or lactating women or women planning to become pregnant during the study and / or within 28 days following the last dose of study medication\n * Known allergies to excipients in ARQ-151 cream\n * Subjects who cannot discontinue the use of strong P-450 cytochrome inducers or inhibitors for two weeks prior to the baseline visit and during the study period.\n * Subjects who are unwilling to refrain from using a tanning bed for 2 weeks before and during the study.\n * Subjects who cannot discontinue systemic therapies and/or topical therapies for the treatment of psoriasis.\n * Subjects with a history of chronic alcohol or drug abuse in past 6 months.\n * History of and/or concurrent condition of serious hypersensitivity (anaphylactic shock or anaphylactoid reaction) to phosphodiesterase type 4 (PDE-4) inhibitors.\n * Current or a history of cancer within 5 years with the exception of fully excised skin basal cell carcinoma, cutaneous squamous cell carcinoma or carcinoma in situ of the cervix.\n * Subjects with active infection that requires oral or intravenous administration of antibiotics, antifungal or antiviral agents.\n * Subjects who are unable to communicate, read or understand language, or who display another condition which makes them unsuitable for clinical study participation.",{"$nulls":4},"Actual","2018-01-05","Actual","Anticipated","2018-06-01","Anticipated","2018-01-01","2017-12-29","2018-01-02","2018-01-02",null,"Psoriasis\nPlaque Psoriasis","Interventional","Treatment","Parallel Assignment","Double (Participant, Investigator)","Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":4},"Yes",{"$nulls":14},"4 Week TPSS x TPA","Difference in mean percent change from baseline at week 4 in the product of:","Target Plaque Severity Score (TPSS) x Target Plaque Area (TPA) (TPSS x TPA) between each dose concentration level of ARQ-151 cream and vehicle control.","1, 2, 3 Week TPSS x TPA|TPSS|TPA","Difference in mean percent change from baseline at weeks 1, 2 and 3 in TPSS x TPA between each dose concentration level of ARQ-151 cream and vehicle control.|Difference in mean percent change from baseline at weeks 1, 2, 3 and 4 in TPSS between each dose concentration level of ARQ-151 cream and vehicle control.|Difference in mean percent change from baseline at weeks 1, 2, 3, and 4 in TPA between each dose concentration level of ARQ-151 cream and vehicle control.","1, 2, and 3 weeks|1, 2, 3, and 4 weeks","StudyInquiry@arcutis.com","Arcutis Study Inquiry","650-847-4115 Ext. 5","Surrey, British Columbia, Canada, V3R 6A7|Markham, Ontario, Canada, L3P 1X2|Santa Monica, California, United States, 90403","California","Canada|United States","British Columbia Dr. Chih-Ho Hong Medical Inc.|Ontario Lynderm Research Inc.|Mosaic Dermatology",{"$nulls":3},"Howard Welgus, M.D.","2018-01-02","2020-05-25T16:35:31.584","2020-05-26T17:10:42.972","NCT03392168"]
["5ecbf3d3feab101b155307f9","NCT03392168","2018-02-19","Arcutis","ARQT","Recruiting","Safety, Pharmacokinetics and Efficacy of ARQ-151 Cream in Adults With Mild to Moderate Chronic Plaque Psoriasis","Arq-151",null,"Yes","['Arq-151']","Unknown",null,"Phase 1/Phase 2",4,92,"Anticipated","2017-12-11","2018-05-01",{"$nulls":5},"This study is designed to assess the safety and pharmacokinetics (PK) of a single dose application of ARQ-151 cream 0.5% to 25 cm2 of psoriatic plaque(s) (Cohort 1). The study will also assess the safety, PK and efficacy of different doses and multiple applications of ARQ-151 cream 0.5% vs placebo and ARQ-151 cream 0.15% vs placebo applied once a day for 28 days to individuals with 0.5% to 5.0% body surface area (BSA) of chronic plaque psoriasis (Cohort 2).","There are 2 cohorts of subjects. Cohort 1 is a single dose study of ARQ-151 0.5% cream applied to 25 cm2 of psoriatic plaque(s) in up to 8 psoriasis subjects. Cohort 2 is a parallel group, double blind, vehicle controlled study in which ARQ-151 cream 0.5%, ARQ-151 cream 0.15% or vehicle cream is applied once a day for 28 days to subjects with between 0.5% to 5.0% BSA of chronic plaque psoriasis. Including both Cohorts, a total of up to 92 subjects will be enrolled at 8 study sites in Canada and the US. Subjects will be adult (â‰¥18 years old) males or females with chronic plaque psoriasis.","A Phase 1/2a Single Dose and 28-day Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety, Pharmacokinetics and Efficacy of ARQ-151 Cream 0.5% and 0.15% in Adults With Mild to Moderate Chronic Plaque Psoriasis","ARQ-151-101","Psoriasis","Psoriasis","Dermatological Diseases","Derm & Connective Tissue Disorders","Experimental|Active Comparator|Placebo Comparator","Cohort 1 - PK and Safety|Cohort 2 - ARQ-151 cream 0.5%|Cohort 2 - ARQ-151 cream 0.15%|Cohort 2 - ARQ-151 cream placebo","Open Label ARQ-151 cream 0.5%|Blinded","Drug","ARQ-151 cream 0.5%|ARQ-151 cream 0.15%|ARQ-151 cream placebo","0.5% active concentration|0.15% active concentration|Cream vehicle",null,"Cohort 1 - PK and Safety|Cohort 2 - ARQ-151 cream 0.5%|Cohort 2 - ARQ-151 cream 0.15%|Cohort 2 - ARQ-151 cream placebo","\n\n * Adult male and female subjects aged â‰¥18 years\n * In Cohort 1, subjects must have at least 25 cm2 of chronic plaque psoriasis (excluding the face, scalp, intertriginous areas, palms and soles).\n * In Cohort 2, subjects must have 0.5% to 5.0% of total BSA of chronic plaque psoriasis and at least one target plaque, of at least 9 cm2 in size with a TPSS â‰¥4 (excluding the face, scalp, intertriginous areas, palms and soles).\n * Women of childbearing potential must have a negative urine pregnancy test at Screening and agree to use birth control throughout the trial.\n * In good health as judged by the Investigator, based on medical history, physical examination, 12-lead electrocardiogram (ECG), serum chemistry labs, hematology values, and urinalysis.\n * Subjects agree not to have prolonged sun exposure during the course of the study. Tanning bed use is not allowed.\n * Subjects are competent to sign and give informed consent and considered reliable and capable of adhering to the Protocol and visit schedule.\n\n","\n\n * Subjects with non-plaque forms of psoriasis (erythrodermic, guttate, pustular or palmo-plantar psoriasis) or with drug-induced psoriasis\n * Evidence of skin conditions other than psoriasis that would interfere with evaluation of the effect of the study medication.\n * Pregnant or lactating women or women planning to become pregnant during the study and / or within 28 days following the last dose of study medication\n * Known allergies to excipients in ARQ-151 cream\n * Subjects who cannot discontinue the use of strong P-450 cytochrome inducers or inhibitors for two weeks prior to the baseline visit and during the study period.\n * Subjects who are unwilling to refrain from using a tanning bed for 2 weeks before and during the study.\n * Subjects who cannot discontinue systemic therapies and/or topical therapies for the treatment of psoriasis.\n * Subjects with a history of chronic alcohol or drug abuse in past 6 months.\n * History of and/or concurrent condition of serious hypersensitivity (anaphylactic shock or anaphylactoid reaction) to phosphodiesterase type 4 (PDE-4) inhibitors.\n * Current or a history of cancer within 5 years with the exception of fully excised skin basal cell carcinoma, cutaneous squamous cell carcinoma or carcinoma in situ of the cervix.\n * Subjects with active infection that requires oral or intravenous administration of antibiotics, antifungal or antiviral agents.\n * Subjects who are unable to communicate, read or understand language, or who display another condition which makes them unsuitable for clinical study participation.",{"$nulls":4},"Actual","2018-01-05","Actual","Anticipated","2018-06-01","Anticipated","2018-02-01","2017-12-29","2018-01-02","2018-02-14",null,"Psoriasis\nPlaque Psoriasis","Interventional","Treatment","Parallel Assignment","Double (Participant, Investigator)","Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":4},"Yes",{"$nulls":14},"4 Week TPSS x TPA","Difference in mean percent change from baseline at week 4 in the product of:","Target Plaque Severity Score (TPSS) x Target Plaque Area (TPA) (TPSS x TPA) between each dose concentration level of ARQ-151 cream and vehicle control.","1, 2, 3 Week TPSS x TPA|TPSS|TPA","Difference in mean percent change from baseline at weeks 1, 2 and 3 in TPSS x TPA between each dose concentration level of ARQ-151 cream and vehicle control.|Difference in mean percent change from baseline at weeks 1, 2, 3 and 4 in TPSS between each dose concentration level of ARQ-151 cream and vehicle control.|Difference in mean percent change from baseline at weeks 1, 2, 3, and 4 in TPA between each dose concentration level of ARQ-151 cream and vehicle control.","1, 2, and 3 weeks|1, 2, 3, and 4 weeks","StudyInquiry@arcutis.com","Arcutis Study Inquiry","650-847-4115 Ext. 5","Surrey, British Columbia, Canada, V3R 6A7|Markham, Ontario, Canada, L3P 1X2|Santa Monica, California, United States, 90403","California","Canada|United States","British Columbia Dr. Chih-Ho Hong Medical Inc.|Ontario Lynderm Research Inc.|Mosaic Dermatology",{"$nulls":3},"Howard Welgus, M.D.","2018-02-14","2020-05-25T16:35:31.409","2020-05-26T17:10:42.972","NCT03392168"]
["5ecbf3d311702c1b1b9169dd","NCT03392168","2018-04-02","Arcutis","ARQT","Active, not recruiting","Safety, Pharmacokinetics and Efficacy of ARQ-151 Cream in Adults With Mild to Moderate Chronic Plaque Psoriasis","Arq-151",null,"Yes","['Arq-151']","Unknown",null,"Phase 1/Phase 2",4,97,"Actual","2017-12-11","2018-05-01",{"$nulls":5},"This study is designed to assess the safety and pharmacokinetics (PK) of a single dose application of ARQ-151 cream 0.5% to 25 cm2 of psoriatic plaque(s) (Cohort 1). The study will also assess the safety, PK and efficacy of different doses and multiple applications of ARQ-151 cream 0.5% vs placebo and ARQ-151 cream 0.15% vs placebo applied once a day for 28 days to individuals with 0.5% to 5.0% body surface area (BSA) of chronic plaque psoriasis (Cohort 2).","There are 2 cohorts of subjects. Cohort 1 is a single dose study of ARQ-151 0.5% cream applied to 25 cm2 of psoriatic plaque(s) in up to 8 psoriasis subjects. Cohort 2 is a parallel group, double blind, vehicle controlled study in which ARQ-151 cream 0.5%, ARQ-151 cream 0.15% or vehicle cream is applied once a day for 28 days to subjects with between 0.5% to 5.0% BSA of chronic plaque psoriasis. Including both Cohorts, a total of up to 92 subjects will be enrolled at 8 study sites in Canada and the US. Subjects will be adult (â‰¥18 years old) males or females with chronic plaque psoriasis.","A Phase 1/2a Single Dose and 28-day Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety, Pharmacokinetics and Efficacy of ARQ-151 Cream 0.5% and 0.15% in Adults With Mild to Moderate Chronic Plaque Psoriasis","ARQ-151-101","Psoriasis","Psoriasis","Dermatological Diseases","Derm & Connective Tissue Disorders","Experimental|Active Comparator|Placebo Comparator","Cohort 1 - PK and Safety|Cohort 2 - ARQ-151 cream 0.5%|Cohort 2 - ARQ-151 cream 0.15%|Cohort 2 - ARQ-151 cream placebo","Open Label ARQ-151 cream 0.5%|Blinded","Drug","ARQ-151 cream 0.5%|ARQ-151 cream 0.15%|ARQ-151 cream placebo","0.5% active concentration|0.15% active concentration|Cream vehicle",null,"Cohort 1 - PK and Safety|Cohort 2 - ARQ-151 cream 0.5%|Cohort 2 - ARQ-151 cream 0.15%|Cohort 2 - ARQ-151 cream placebo","\n\n * Adult male and female subjects aged â‰¥18 years\n * In Cohort 1, subjects must have at least 25 cm2 of chronic plaque psoriasis (excluding the face, scalp, intertriginous areas, palms and soles).\n * In Cohort 2, subjects must have 0.5% to 5.0% of total BSA of chronic plaque psoriasis and at least one target plaque, of at least 9 cm2 in size with a TPSS â‰¥4 (excluding the face, scalp, intertriginous areas, palms and soles).\n * Women of childbearing potential must have a negative urine pregnancy test at Screening and agree to use birth control throughout the trial.\n * In good health as judged by the Investigator, based on medical history, physical examination, 12-lead electrocardiogram (ECG), serum chemistry labs, hematology values, and urinalysis.\n * Subjects agree not to have prolonged sun exposure during the course of the study. Tanning bed use is not allowed.\n * Subjects are competent to sign and give informed consent and considered reliable and capable of adhering to the Protocol and visit schedule.\n\n","\n\n * Subjects with non-plaque forms of psoriasis (erythrodermic, guttate, pustular or palmo-plantar psoriasis) or with drug-induced psoriasis\n * Evidence of skin conditions other than psoriasis that would interfere with evaluation of the effect of the study medication.\n * Pregnant or lactating women or women planning to become pregnant during the study and / or within 28 days following the last dose of study medication\n * Known allergies to excipients in ARQ-151 cream\n * Subjects who cannot discontinue the use of strong P-450 cytochrome inducers or inhibitors for two weeks prior to the baseline visit and during the study period.\n * Subjects who are unwilling to refrain from using a tanning bed for 2 weeks before and during the study.\n * Subjects who cannot discontinue systemic therapies and/or topical therapies for the treatment of psoriasis.\n * Subjects with a history of chronic alcohol or drug abuse in past 6 months.\n * History of and/or concurrent condition of serious hypersensitivity (anaphylactic shock or anaphylactoid reaction) to phosphodiesterase type 4 (PDE-4) inhibitors.\n * Current or a history of cancer within 5 years with the exception of fully excised skin basal cell carcinoma, cutaneous squamous cell carcinoma or carcinoma in situ of the cervix.\n * Subjects with active infection that requires oral or intravenous administration of antibiotics, antifungal or antiviral agents.\n * Subjects who are unable to communicate, read or understand language, or who display another condition which makes them unsuitable for clinical study participation.",{"$nulls":4},"Actual","2018-01-05","Actual","Anticipated","2018-06-01","Anticipated","2018-03-01","2017-12-29","2018-01-02","2018-03-30",null,"Psoriasis\nPlaque Psoriasis","Interventional","Treatment","Parallel Assignment","Double (Participant, Investigator)","Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":4},"Yes",{"$nulls":14},"4 Week TPSS x TPA","Difference in mean percent change from baseline at week 4 in the product of:","Target Plaque Severity Score (TPSS) x Target Plaque Area (TPA) (TPSS x TPA) between each dose concentration level of ARQ-151 cream and vehicle control.","1, 2, 3 Week TPSS x TPA|TPSS|TPA","Difference in mean percent change from baseline at weeks 1, 2 and 3 in TPSS x TPA between each dose concentration level of ARQ-151 cream and vehicle control.|Difference in mean percent change from baseline at weeks 1, 2, 3 and 4 in TPSS between each dose concentration level of ARQ-151 cream and vehicle control.|Difference in mean percent change from baseline at weeks 1, 2, 3, and 4 in TPA between each dose concentration level of ARQ-151 cream and vehicle control.","1, 2, and 3 weeks|1, 2, 3, and 4 weeks",{"$nulls":3},"Surrey, British Columbia, Canada, V3R 6A7|Markham, Ontario, Canada, L3P 1X2 Research By IclsOakville, Ontario, Canada, L6J 7W5 Skin Centre For DermatologyPeterborough, Ontario, Canada, K9J 5K2 The Centre For DermatologyRichmond Hill, Ontario, Canada, L4B 1A5 K. Papp Clinical Research Inc.Waterloo, Ontario, Canada, N2J 1C4 Xlr8 Medical Research Inc.Windsor, Ontario, Canada, N8W 1E6|Santa Monica, California, United States, 90403","California","Canada|United States","British Columbia Dr. Chih-Ho Hong Medical Inc.|Ontario Lynderm Research Inc.|Mosaic Dermatology",{"$nulls":3},"Howard Welgus, M.D.","2018-03-30","2020-05-25T16:35:31.501","2020-05-26T17:10:42.972","NCT03392168"]
["5ecbf3d3e2561b1b11905cc5","NCT03392168","2018-06-26","Arcutis","ARQT","Completed","Safety, Pharmacokinetics and Efficacy of ARQ-151 Cream in Adults With Mild to Moderate Chronic Plaque Psoriasis","Arq-151",null,"Yes","['Arq-151']","Unknown",null,"Phase 1/Phase 2",4,97,"Actual","2017-12-11","2018-04-26",{"$nulls":5},"This study is designed to assess the safety and pharmacokinetics (PK) of a single dose application of ARQ-151 cream 0.5% to 25 cm2 of psoriatic plaque(s) (Cohort 1). The study will also assess the safety, PK and efficacy of different doses and multiple applications of ARQ-151 cream 0.5% vs placebo and ARQ-151 cream 0.15% vs placebo applied once a day for 28 days to individuals with 0.5% to 5.0% body surface area (BSA) of chronic plaque psoriasis (Cohort 2).","There are 2 cohorts of subjects. Cohort 1 is a single dose study of ARQ-151 0.5% cream applied to 25 cm2 of psoriatic plaque(s) in up to 8 psoriasis subjects. Cohort 2 is a parallel group, double blind, vehicle controlled study in which ARQ-151 cream 0.5%, ARQ-151 cream 0.15% or vehicle cream is applied once a day for 28 days to subjects with between 0.5% to 5.0% BSA of chronic plaque psoriasis. Including both Cohorts, a total of up to 92 subjects will be enrolled at 8 study sites in Canada and the US. Subjects will be adult (â‰¥18 years old) males or females with chronic plaque psoriasis.","A Phase 1/2a Single Dose and 28-day Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety, Pharmacokinetics and Efficacy of ARQ-151 Cream 0.5% and 0.15% in Adults With Mild to Moderate Chronic Plaque Psoriasis","ARQ-151-101","Psoriasis","Psoriasis","Dermatological Diseases","Derm & Connective Tissue Disorders","Experimental|Active Comparator|Placebo Comparator","Cohort 1 - PK and Safety|Cohort 2 - ARQ-151 cream 0.5%|Cohort 2 - ARQ-151 cream 0.15%|Cohort 2 - ARQ-151 cream placebo","Open Label ARQ-151 cream 0.5%|Blinded","Drug","ARQ-151 cream 0.5%|ARQ-151 cream 0.15%|ARQ-151 cream placebo","0.5% active concentration|0.15% active concentration|Cream vehicle",null,"Cohort 1 - PK and Safety|Cohort 2 - ARQ-151 cream 0.5%|Cohort 2 - ARQ-151 cream 0.15%|Cohort 2 - ARQ-151 cream placebo","\n\n * Adult male and female subjects aged â‰¥18 years\n * In Cohort 1, subjects must have at least 25 cm2 of chronic plaque psoriasis (excluding the face, scalp, intertriginous areas, palms and soles).\n * In Cohort 2, subjects must have 0.5% to 5.0% of total BSA of chronic plaque psoriasis and at least one target plaque, of at least 9 cm2 in size with a TPSS â‰¥4 (excluding the face, scalp, intertriginous areas, palms and soles).\n * Women of childbearing potential must have a negative urine pregnancy test at Screening and agree to use birth control throughout the trial.\n * In good health as judged by the Investigator, based on medical history, physical examination, 12-lead electrocardiogram (ECG), serum chemistry labs, hematology values, and urinalysis.\n * Subjects agree not to have prolonged sun exposure during the course of the study. Tanning bed use is not allowed.\n * Subjects are competent to sign and give informed consent and considered reliable and capable of adhering to the Protocol and visit schedule.\n\n","\n\n * Subjects with non-plaque forms of psoriasis (erythrodermic, guttate, pustular or palmo-plantar psoriasis) or with drug-induced psoriasis\n * Evidence of skin conditions other than psoriasis that would interfere with evaluation of the effect of the study medication.\n * Pregnant or lactating women or women planning to become pregnant during the study and / or within 28 days following the last dose of study medication\n * Known allergies to excipients in ARQ-151 cream\n * Subjects who cannot discontinue the use of strong P-450 cytochrome inducers or inhibitors for two weeks prior to the baseline visit and during the study period.\n * Subjects who are unwilling to refrain from using a tanning bed for 2 weeks before and during the study.\n * Subjects who cannot discontinue systemic therapies and/or topical therapies for the treatment of psoriasis.\n * Subjects with a history of chronic alcohol or drug abuse in past 6 months.\n * History of and/or concurrent condition of serious hypersensitivity (anaphylactic shock or anaphylactoid reaction) to phosphodiesterase type 4 (PDE-4) inhibitors.\n * Current or a history of cancer within 5 years with the exception of fully excised skin basal cell carcinoma, cutaneous squamous cell carcinoma or carcinoma in situ of the cervix.\n * Subjects with active infection that requires oral or intravenous administration of antibiotics, antifungal or antiviral agents.\n * Subjects who are unable to communicate, read or understand language, or who display another condition which makes them unsuitable for clinical study participation.",{"$nulls":4},"Actual","2018-01-05","Actual","Actual","2018-05-02","Actual","2018-06-01","2017-12-29","2018-01-02","2018-06-25",null,"Psoriasis\nPlaque Psoriasis","Interventional","Treatment","Parallel Assignment","Double (Participant, Investigator)","Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":4},"Yes",{"$nulls":14},"4 Week TPSS x TPA","Difference in mean percent change from baseline at week 4 in the product of:","Target Plaque Severity Score (TPSS) x Target Plaque Area (TPA) (TPSS x TPA) between each dose concentration level of ARQ-151 cream and vehicle control.","1, 2, 3 Week TPSS x TPA|TPSS|TPA","Difference in mean percent change from baseline at weeks 1, 2 and 3 in TPSS x TPA between each dose concentration level of ARQ-151 cream and vehicle control.|Difference in mean percent change from baseline at weeks 1, 2, 3 and 4 in TPSS between each dose concentration level of ARQ-151 cream and vehicle control.|Difference in mean percent change from baseline at weeks 1, 2, 3, and 4 in TPA between each dose concentration level of ARQ-151 cream and vehicle control.","1, 2, and 3 weeks|1, 2, 3, and 4 weeks",{"$nulls":3},"Surrey, British Columbia, Canada, V3R 6A7|Markham, Ontario, Canada, L3P 1X2 Research By IclsOakville, Ontario, Canada, L6J 7W5 Skin Centre For DermatologyPeterborough, Ontario, Canada, K9J 5K2 The Centre For DermatologyRichmond Hill, Ontario, Canada, L4B 1A5 K. Papp Clinical Research Inc.Waterloo, Ontario, Canada, N2J 1C4 Xlr8 Medical Research Inc.Windsor, Ontario, Canada, N8W 1E6|Santa Monica, California, United States, 90403","California","Canada|United States","British Columbia Dr. Chih-Ho Hong Medical Inc.|Ontario Lynderm Research Inc.|Mosaic Dermatology",{"$nulls":3},"Howard Welgus, M.D.","2018-06-25","2020-05-25T16:35:31.735","2020-05-26T17:10:42.972","NCT03392168"]
["5ecbf3d3307e3d1b1f8d9c5a","NCT03392168","2020-03-13","Arcutis","ARQT","Completed","Safety, Pharmacokinetics and Efficacy of ARQ-151 Cream in Adults With Mild to Moderate Chronic Plaque Psoriasis","Arq-151",null,"Yes","['Arq-151']","Unknown",null,"Phase 1/Phase 2",4,97,"Actual","2017-12-11","2018-04-26",{"$nulls":5},"This study is designed to assess the safety and pharmacokinetics (PK) of a single dose application of ARQ-151 cream 0.5% to 25 cm2 of psoriatic plaque(s) (Cohort 1). The study will also assess the safety, PK and efficacy of different doses and multiple applications of ARQ-151 cream 0.5% vs placebo and ARQ-151 cream 0.15% vs placebo applied once a day for 28 days to individuals with 0.5% to 5.0% body surface area (BSA) of chronic plaque psoriasis (Cohort 2).","There are 2 cohorts of subjects. Cohort 1 is a single dose study of ARQ-151 0.5% cream applied to 25 cm2 of psoriatic plaque(s) in up to 8 psoriasis subjects. Cohort 2 is a parallel group, double blind, vehicle controlled study in which ARQ-151 cream 0.5%, ARQ-151 cream 0.15% or vehicle cream is applied once a day for 28 days to subjects with between 0.5% to 5.0% BSA of chronic plaque psoriasis. Including both Cohorts, a total of up to 92 subjects will be enrolled at 8 study sites in Canada and the US. Subjects will be adult (â‰¥18 years old) males or females with chronic plaque psoriasis.","A Phase 1/2a Single Dose and 28-day Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety, Pharmacokinetics and Efficacy of ARQ-151 Cream 0.5% and 0.15% in Adults With Mild to Moderate Chronic Plaque Psoriasis","ARQ-151-101","Psoriasis","Psoriasis","Dermatological Diseases","Derm & Connective Tissue Disorders","Experimental|Active Comparator|Placebo Comparator","Cohort 1 - PK and Safety|Cohort 2 - ARQ-151 cream 0.5%|Cohort 2 - ARQ-151 cream 0.15%|Cohort 2 - ARQ-151 cream placebo","Open Label ARQ-151 cream 0.5%|Blinded","Drug","ARQ-151 cream 0.5%|ARQ-151 cream 0.15%|ARQ-151 cream placebo","0.5% active concentration|0.15% active concentration|Cream vehicle",null,"Cohort 1 - PK and Safety|Cohort 2 - ARQ-151 cream 0.5%|Cohort 2 - ARQ-151 cream 0.15%|Cohort 2 - ARQ-151 cream placebo","\n\n * Adult male and female subjects aged â‰¥18 years\n * In Cohort 1, subjects must have at least 25 cm2 of chronic plaque psoriasis (excluding the face, scalp, intertriginous areas, palms and soles).\n * In Cohort 2, subjects must have 0.5% to 5.0% of total BSA of chronic plaque psoriasis and at least one target plaque, of at least 9 cm2 in size with a TPSS â‰¥4 (excluding the face, scalp, intertriginous areas, palms and soles).\n * Women of childbearing potential must have a negative urine pregnancy test at Screening and agree to use birth control throughout the trial.\n * In good health as judged by the Investigator, based on medical history, physical examination, 12-lead electrocardiogram (ECG), serum chemistry labs, hematology values, and urinalysis.\n * Subjects agree not to have prolonged sun exposure during the course of the study. Tanning bed use is not allowed.\n * Subjects are competent to sign and give informed consent and considered reliable and capable of adhering to the Protocol and visit schedule.\n\n","\n\n * Subjects with non-plaque forms of psoriasis (erythrodermic, guttate, pustular or palmo-plantar psoriasis) or with drug-induced psoriasis\n * Evidence of skin conditions other than psoriasis that would interfere with evaluation of the effect of the study medication.\n * Pregnant or lactating women or women planning to become pregnant during the study and / or within 28 days following the last dose of study medication\n * Known allergies to excipients in ARQ-151 cream\n * Subjects who cannot discontinue the use of strong P-450 cytochrome inducers or inhibitors for two weeks prior to the baseline visit and during the study period.\n * Subjects who are unwilling to refrain from using a tanning bed for 2 weeks before and during the study.\n * Subjects who cannot discontinue systemic therapies and/or topical therapies for the treatment of psoriasis.\n * Subjects with a history of chronic alcohol or drug abuse in past 6 months.\n * History of and/or concurrent condition of serious hypersensitivity (anaphylactic shock or anaphylactoid reaction) to phosphodiesterase type 4 (PDE-4) inhibitors.\n * Current or a history of cancer within 5 years with the exception of fully excised skin basal cell carcinoma, cutaneous squamous cell carcinoma or carcinoma in situ of the cervix.\n * Subjects with active infection that requires oral or intravenous administration of antibiotics, antifungal or antiviral agents.\n * Subjects who are unable to communicate, read or understand language, or who display another condition which makes them unsuitable for clinical study participation.",{"$nulls":4},"Actual","2018-01-05","Actual","Actual","2018-05-02","Actual","2018-06-01","2017-12-29","2018-01-02","2020-03-09",null,"Psoriasis\nPlaque Psoriasis","Interventional","Treatment","Parallel Assignment","Double (Participant, Investigator)","Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":4},"Yes",null,null,43899,43899,"March 13, 2020 [Actual]",{"$nulls":9},"4 Week TPSS x TPA","Difference in mean percent change from baseline at week 4 in the product of:","Target Plaque Severity Score (TPSS) x Target Plaque Area (TPA) (TPSS x TPA) between each dose concentration level of ARQ-151 cream and vehicle control.","1, 2, 3 Week TPSS x TPA|TPSS|TPA","Difference in mean percent change from baseline at weeks 1, 2 and 3 in TPSS x TPA between each dose concentration level of ARQ-151 cream and vehicle control.|Difference in mean percent change from baseline at weeks 1, 2, 3 and 4 in TPSS between each dose concentration level of ARQ-151 cream and vehicle control.|Difference in mean percent change from baseline at weeks 1, 2, 3, and 4 in TPA between each dose concentration level of ARQ-151 cream and vehicle control.","1, 2, and 3 weeks|1, 2, 3, and 4 weeks",{"$nulls":3},"Surrey, British Columbia, Canada, V3R 6A7|Markham, Ontario, Canada, L3P 1X2 Research By IclsOakville, Ontario, Canada, L6J 7W5 Skin Centre For DermatologyPeterborough, Ontario, Canada, K9J 5K2 The Centre For DermatologyRichmond Hill, Ontario, Canada, L4B 1A5 K. Papp Clinical Research Inc.Waterloo, Ontario, Canada, N2J 1C4 Xlr8 Medical Research Inc.Windsor, Ontario, Canada, N8W 1E6|Santa Monica, California, United States, 90403","California","Canada|United States","British Columbia Dr. Chih-Ho Hong Medical Inc.|Ontario Lynderm Research Inc.|Mosaic Dermatology",{"$nulls":3},"Howard Welgus, M.D.","2020-03-09","2020-05-25T16:35:31.786","2020-05-26T17:10:42.972","NCT03392168"]
["5ecbf3d3e2561b1b11905cc6","NCT03392168","2020-04-24","Arcutis","ARQT","Completed","Safety, Pharmacokinetics and Efficacy of ARQ-151 Cream in Adults With Mild to Moderate Chronic Plaque Psoriasis","Arq-151",null,"Yes","['Arq-151']","Unknown",null,"Phase 1/Phase 2",4,97,"Actual","2017-12-11","2018-05-02",{"$nulls":5},"This study is designed to assess the safety and pharmacokinetics (PK) of a single dose application of ARQ-151 cream 0.5% to 25 cm2 of psoriatic plaque(s) (Cohort 1). The study will also assess the safety, PK and efficacy of different doses and multiple applications of ARQ-151 cream 0.5% vs placebo and ARQ-151 cream 0.15% vs placebo applied once a day for 28 days to individuals with 0.5% to 5.0% body surface area (BSA) of chronic plaque psoriasis (Cohort 2).","There are 2 cohorts of subjects. Cohort 1 is a single dose study of ARQ-151 0.5% cream applied to 25 cm2 of psoriatic plaque(s) in up to 8 psoriasis subjects. Cohort 2 is a parallel group, double blind, vehicle controlled study in which ARQ-151 cream 0.5%, ARQ-151 cream 0.15% or vehicle cream is applied once a day for 28 days to subjects with between 0.5% to 5.0% BSA of chronic plaque psoriasis. Including both Cohorts, a total of up to 92 subjects will be enrolled at 8 study sites in Canada and the US. Subjects will be adult (â‰¥18 years old) males or females with chronic plaque psoriasis.","A Phase 1/2a Single Dose and 28-day Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety, Pharmacokinetics and Efficacy of ARQ-151 Cream 0.5% and 0.15% in Adults With Mild to Moderate Chronic Plaque Psoriasis","ARQ-151-101","Psoriasis","Psoriasis","Dermatological Diseases","Derm & Connective Tissue Disorders","Experimental|Active Comparator|Placebo Comparator","Cohort 1 - PK and Safety|Cohort 2 - ARQ-151 cream 0.5%|Cohort 2 - ARQ-151 cream 0.15%|Cohort 2 - ARQ-151 cream placebo","Open Label ARQ-151 cream 0.5%|Blinded","Drug","ARQ-151 cream 0.5%|ARQ-151 cream 0.15%|ARQ-151 cream placebo","0.5% active concentration|0.15% active concentration|Cream vehicle",null,"Cohort 1 - PK and Safety|Cohort 2 - ARQ-151 cream 0.5%|Cohort 2 - ARQ-151 cream 0.15%|Cohort 2 - ARQ-151 cream placebo","\n\n * Adult male and female subjects aged â‰¥18 years\n * In Cohort 1, subjects must have at least 25 cm2 of chronic plaque psoriasis (excluding the face, scalp, intertriginous areas, palms and soles).\n * In Cohort 2, subjects must have 0.5% to 5.0% of total BSA of chronic plaque psoriasis and at least one target plaque, of at least 9 cm2 in size with a TPSS â‰¥4 (excluding the face, scalp, intertriginous areas, palms and soles).\n * Women of childbearing potential must have a negative urine pregnancy test at Screening and agree to use birth control throughout the trial.\n * In good health as judged by the Investigator, based on medical history, physical examination, 12-lead electrocardiogram (ECG), serum chemistry labs, hematology values, and urinalysis.\n * Subjects agree not to have prolonged sun exposure during the course of the study. Tanning bed use is not allowed.\n * Subjects are competent to sign and give informed consent and considered reliable and capable of adhering to the Protocol and visit schedule.\n\n","\n\n * Subjects with non-plaque forms of psoriasis (erythrodermic, guttate, pustular or palmo-plantar psoriasis) or with drug-induced psoriasis\n * Evidence of skin conditions other than psoriasis that would interfere with evaluation of the effect of the study medication.\n * Pregnant or lactating women or women planning to become pregnant during the study and / or within 28 days following the last dose of study medication\n * Known allergies to excipients in ARQ-151 cream\n * Subjects who cannot discontinue the use of strong P-450 cytochrome inducers or inhibitors for two weeks prior to the baseline visit and during the study period.\n * Subjects who are unwilling to refrain from using a tanning bed for 2 weeks before and during the study.\n * Subjects who cannot discontinue systemic therapies and/or topical therapies for the treatment of psoriasis.\n * Subjects with a history of chronic alcohol or drug abuse in past 6 months.\n * History of and/or concurrent condition of serious hypersensitivity (anaphylactic shock or anaphylactoid reaction) to phosphodiesterase type 4 (PDE-4) inhibitors.\n * Current or a history of cancer within 5 years with the exception of fully excised skin basal cell carcinoma, cutaneous squamous cell carcinoma or carcinoma in situ of the cervix.\n * Subjects with active infection that requires oral or intravenous administration of antibiotics, antifungal or antiviral agents.\n * Subjects who are unable to communicate, read or understand language, or who display another condition which makes them unsuitable for clinical study participation.",{"$nulls":4},"Actual","2018-01-05","Actual","Actual","2018-05-02","Actual","2020-04-01","2017-12-29","2018-01-02","2020-04-20",null,"Psoriasis\nPlaque Psoriasis","Interventional","Treatment","Parallel Assignment","Double (Participant, Investigator)","Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":4},"Yes",null,null,43899,43899,"March 13, 2020 [Actual]",{"$nulls":9},"4 Week TPSS x TPA","Difference in mean percent change from baseline at week 4 in the product of:","Target Plaque Severity Score (TPSS) x Target Plaque Area (TPA) (TPSS x TPA) between each dose concentration level of ARQ-151 cream and vehicle control.","1, 2, 3 Week TPSS x TPA|TPSS|TPA","Difference in mean percent change from baseline at weeks 1, 2 and 3 in TPSS x TPA between each dose concentration level of ARQ-151 cream and vehicle control.|Difference in mean percent change from baseline at weeks 1, 2, 3 and 4 in TPSS between each dose concentration level of ARQ-151 cream and vehicle control.|Difference in mean percent change from baseline at weeks 1, 2, 3, and 4 in TPA between each dose concentration level of ARQ-151 cream and vehicle control.","1, 2, and 3 weeks|1, 2, 3, and 4 weeks",{"$nulls":3},"Surrey, British Columbia, Canada, V3R 6A7|Markham, Ontario, Canada, L3P 1X2 Research By IclsOakville, Ontario, Canada, L6J 7W5 Skin Centre For DermatologyPeterborough, Ontario, Canada, K9J 5K2 The Centre For DermatologyRichmond Hill, Ontario, Canada, L4B 1A5 K. Papp Clinical Research Inc.Waterloo, Ontario, Canada, N2J 1C4 Xlr8 Medical Research Inc.Windsor, Ontario, Canada, N8W 1E6|Santa Monica, California, United States, 90403","California","Canada|United States","British Columbia Dr. Chih-Ho Hong Medical Inc.|Ontario Lynderm Research Inc.|Mosaic Dermatology",{"$nulls":3},"Howard Welgus, M.D.","2020-04-20","2020-05-25T16:35:31.796","2020-05-26T17:10:42.972","NCT03392168"]
["5ecbf3dbfeab101b1553080c","NCT03393013","2018-01-08","Kezar Life Sciences","KZR","Not yet recruiting","A Study of KZR-616 in Patients With Systemic Lupus Erythematosus With and Without Nephritis","Kzr-616","Proteasome Inhibitor","Yes","['Kzr-616']","No",null,"Phase 1/Phase 2",3,72,"Anticipated","2018-01-01","2020-02-01",{"$nulls":5},"This is a Phase 1b/2, multi-center study in which patients will receive KZR-616, administered as a subcutaneous injection weekly for 13 weeks.\n\nThe study consists of 2 parts. Part 1, the Phase 1b, is an open-label multiple dose escalation study to evaluate the safety and tolerability of KZR-616 in patients with systemic lupus erythematosus (SLE) with and without nephritis. Part 2, the Phase 2, is a randomized, placebo-controlled, double-blind study to evaluate the safety and efficacy of KZR-616 in patients with active proliferative lupus nephritis (LN).",null,"A Phase 1b/2 Study of KZR-616 in Patients With Systemic Lupus Erythematosus With and Without Nephritis","KZR-616-002","Systemic Lupus Erythematosus\nLupus Nephritis","Lupus Erythematosus|Lupus Erythematosus, Systemic|Erythema|Lupus Nephritis|Nephritis","Connective Tissue Diseases|Dermatological Diseases|Urologic Diseases","Derm & Connective Tissue Disorders|Reproductive and Urogenital","Experimental|Placebo Comparator","KZR-616 Dose Level 1 + standard therapy|KZR-616 Dose Level 2 + standard therapy|Placebo + standard therapy","1 of 2 dose levels of KZR-616 selected based on data from the Phase 1 dose escalation and administered in combination with Mycophenolate Mofetil and prednisone|Placebo administered with Mycophenolate Mofetil and prednisone","Drug","KZR-616|Placebo","Subcutaneous Injection of KZR-616|Subcutaneous injection of matching placebo",null,"KZR-616 Dose Level 1 + standard therapy|KZR-616 Dose Level 2 + standard therapy|Placebo + standard therapy","\n\nPHASE 1:\n\n 1. Body Mass Index (BMI) of 18-35 kg/m2\n 2. Fulfils the 2012 Systemic Lupus International Collaborating Clinics (SLICC) classification criteria for SLE\n 3. Have at least one of the following at screening per central lab: 1. Positive antinuclear antibody (ANA) test (1:40 or higher); or\n     2. Anti-double stranded deoxynucleic acid (dsDNA) antibodies elevated to above normal; or\n     3. Anti-Smith antibody elevated to above normal (i.e., positive or equivocal results)\n    \n    \n 4. Active SLE as indicated by a SLEDAI-2K total score â‰¥ 4 at screening\n 5. Must have received 1 or more therapies for SLE\n 6. Acceptable screening laboratory values of concern, including: 1. Adequate hematologic criteria:\n     2. Adequate hepatic function:\n     3. Pancreatic enzymes\n     4. eGFR â‰¥ 50 mL/min/1.73 m2 (estimated based on Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula)\n     5. IgG â‰¥ 500 mg/dL\n    \n    \n 7. If taking the following SLE therapies: 1. Oral glucocorticoids (up to 20 mg/day prednisone or equivalent): must be on a stable dosage regimen of oral corticosteroid at least 4 weeks prior to screening\n     2. Hydroxychloroquine (â‰¤ 400 mg/day) or chloroquine (â‰¤ 500 mg/day) or other anti-malarials: must be started or stopped at least 12 weeks prior to screening, with stable dosage regimen for at least 4 weeks prior to screening\n     3. Immunosuppressive agents: must be started or stopped at least 12 weeks prior to screening, with stable dosage regimen for at least 4 weeks prior to screening: * Mycophenolate mofetil (â‰¤ 3 g/day) or mycophenolic acid (â‰¤ 2.16 g/day)\n         * Azathioprine (â‰¤ 200 mg/day)\n         * Methotrexate (â‰¤ 25 mg/week)\n         * Leflunomide (â‰¤ 20 mg/day)\n        \n        \n    \n    \n\nPHASE 2:\n\n 1. BMI of 18-35 kg/m2\n 2. Fulfils the 2012 Systemic Lupus International Collaborating Clinics (SLICC) classification criteria for SLE.\n 3. Undergoing an ACR-recommended MMF- or MPA-based induction therapy regimen for lupus nephritis for 1-3 months, and willing to continue at least the MMF/MPA portion of the regimen unaltered throughout the duration of the study. Must be receiving a stable regimen of oral glucocorticoids for at least 2 weeks prior to screening\n 4. The patient has at least one of the following at screening per central lab: 1. Positive ANA test (1:40 or higher) or\n     2. anti-dsDNA antibodies elevated to above normal (including indeterminate and positive results); or\n     3. anti-Smith antibody at screening elevated to above normal (i.e., positive or equivocal results)\n    \n    \n 5. Kidney biopsy within 6 months prior to screening with a histologic diagnosis of LN (International Society of Nephrology/Renal Pathology Society 2003 classification of lupus nephritis [ISN/RPS]) Classes III, IV-S or IV-G, (A) or (A/C); Patients with isolated Class V LN will not be permitted on study but patients with Class III or IV and concomitant Class V will be permitted provided their UPCR meets the criterion set below (NOTE: Patients meeting all inclusion criteria with a kidney biopsy of greater than 6 months will be allowed following a repeat biopsy prior to study entry.)\n 6. UPCR of â‰¥ 1.0 in 24-hour urine collection in patients with active LN of ISN/RPS class III or IV, Â±V (UPCR â‰¥ 2.0 if concomitant with class V)\n 7. Acceptable screening laboratory values of concern, including: 1. Adequate hematologic criteria:\n     2. Adequate hepatic function:\n     3. Pancreatic enzymes\n     4. eGFR â‰¥ 50 mL/min/1.73 m2 estimated based on CKD-EPI formula\n     5. IgG â‰¥ 500 mg/dL\n    \n    \n\n","\n\nPHASE 1:\n\n 1. Active central nervous system involvement by autoimmune disease\n 2. Receipt of any of the following treatments within the following timeframes before screening 1. Glucocorticoids â‰¥ 100 mg prednisone or equivalent: 4 weeks\n     2. Intravenous Immunoglobulin (IVIg): 4 weeks\n     3. Other non-biologic immunosuppressive agents, such as cyclosporine, tacrolimus: 4 weeks\n     4. Cyclophosphamide: 12 weeks\n     5. Cytokine antagonists: 12 weeks\n     6. B-cell-depleting therapies (e.g., rituximab): 24 weeks\n     7. Other biologics or investigational drugs: 8 weeks or 5 half-lives, whichever is longer\n     8. Transfusion with blood, packed red blood cells, platelets or treatment with plasmapheresis or plasma exchange: 6 weeks\n    \n    \n 3. Patient has had recent serious or ongoing infection, or risk for serious infection\n 4. History of cancer (except for in situ cancer, excised, or limited stage, curatively treated cancer with no sign of disease for > 5 years)\n 5. Major surgery within 4 weeks before signing the informed consent form (ICF) or major surgery planned during the study period\n\nPHASE 2:\n\n 1.  Active central nervous system involvement by autoimmune disease\n 2.  Isolated Class V membranous LN on a renal biopsy obtained within 6 months prior to signing ICF or during the screening period\n 3.  Known intolerance to MMF or mycophenolic acid\n 4.  History of dialysis within 12 months prior to signing the ICF or expected need for renal replacement therapy (dialysis or renal transplant) within a 6-month period after enrollment\n 5.  History of Rapidly Progressive Glomerulonephritis (RPGN) and/or other renal disease\n 6.  History of chronic kidney disease not directly due to LN\n 7.  Hypertension (Unable to maintain blood pressure with a systolic blood pressure of < 140 mmHg and a diastolic blood pressure of < 90 mmHg at rest)o If currently on RAS blockade (ACEI, ARB, direct renin inhibitors), dose must be stable for at least 4 weeks prior to screening\n     \n     \n 8.  Receipt of any of the following treatments within the following timeframes before first day of study treatment: 1. IVIg: 4 weeks\n      2. Glucocorticoids â‰¥ 1 g/day prednisone or equivalent: 4 weeks\n      3. Intra-articular therapies, such as corticosteroids: 4 weeks\n      4. Conventional disease-modifying antirheumatic drugs, including methotrexate, leflunomide, sulfasalazine, cyclosporine, tacrolimus: 12 weeks\n      5. MMF of â‰¥ 3 g (or 2.16 g of MPA) for â‰¥ 1 month, cyclophosphamide: 24 weeks\n      6. Cytokine antagonists: 12 weeks\n      7. B-cell-depleting therapies (e.g., rituximab): 24 weeks\n      8. Other biologics or investigational drugs: 8 weeks or 5 half-lives, whichever is longer\n     \n     \n 9.  Major surgery within 4 weeks before signing the ICF or major surgery planned during the study period\n 10. Patient has had recent serious or ongoing infection, or risk for serious infection\n 11. Clinical evidence of significant unstable or uncontrolled acute or chronic diseases\n 12. History of cancer (except for in situ cancer, excised, or limited stage, curatively treated cancer with no sign of disease for > 5 years)","EGFR","epidermal growth factor receptor","Protein","Ovary, Breast, Lung","Actual","2018-01-08","Actual","Anticipated","2020-05-01","Anticipated","2018-01-01","2017-12-21","2018-01-04","2018-01-04",null,"immunoproteasome inhibition\nselective proteasome inhibition\nproteasome","Interventional","Treatment","Sequential Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years","70 Years","All",null,"No","Undecided",{"$nulls":3},"Yes","No",{"$nulls":19},"Phase 1 and Phase 2: Safety and Tolerability assessed by monitoring incidence and severity of adverse events","Baseline through 25 weeks",null,"Phase 1: Identify Recommended Phase 2 dose levels (RP2Ds) of KZR-616|Phase 1: Peak plasma concentration (Cmax) following injection with KZR-616|Phase 1: Time to peak plasma concentration (Tmax) of KZR-616|Phase 1: Area under the plasma concentration versus time curve (AUC) of KZR-616|Phase 1: Half-life of KZR-616 (T1/2)|Phase 2: The number of patients with a 50% reduction in urine protein to creatinine ratio (UPCR)|Phase 2: The number of patients with a complete renal response|Phase 2: Change from baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K)|Phase 2: Change from baseline in British Isles Lupus Assessment Group (BILAG) score|Phase 2: Change from baseline in Levels of Autoantibodies (ANA and anti-dsDNA) and Complement (C3 and C4)|Phase 2: Change from baseline in UPCR|Phase 2: Change from baseline in eGFR|Phase 2: Change from baseline in daily glucocorticoid use|Other Pre-specified Outcome Measures:|Phase 1 and 2: Inhibition of chymotrypsin-like (CT-L) activity in whole blood and peripheral blood mononuclear cells (PBMCs);|Phase 1 and 2: Assessment of proteasome sub-unit occupancy in whole blood and PBMCs","Determined through assessment of all AEs and any dose limiting toxicities (DLTs)|Day 1|Day 29|Baseline and every 4 weeks through 25 weeks|UPCR of â‰¤ 0.5; estimated Glomerular Filtration Rate (eGFR) of â‰¥ 60 mL/min or no worsening of eGFR from baseline of > 20%; No discontinuation of investigational product or use of restricted medication beyond the protocol-allowed thresholds from Days 1 to 85|Other Pre-specified Outcome Measures:","4 weeks|Every 4 weeks through 25 weeks","dbomba@kezarbio.com","Director of Clinical Operations","650 822-5617",{"$nulls":8},"2018-01-04","2020-05-25T16:35:39.672","2020-05-26T17:10:42.972","NCT03393013"]
["5ecbf3dcfe30261b1a0481dd","NCT03393013","2018-03-09","Kezar Life Sciences","KZR","Recruiting","A Study of KZR-616 in Patients With Systemic Lupus Erythematosus With and Without Nephritis","Kzr-616","Proteasome Inhibitor","Yes","['Kzr-616']","No",null,"Phase 1/Phase 2",3,72,"Anticipated","2018-03-07","2020-02-01",{"$nulls":5},"This is a Phase 1b/2, multi-center study in which patients will receive KZR-616, administered as a subcutaneous injection weekly for 13 weeks.\n\nThe study consists of 2 parts. Part 1, the Phase 1b, is an open-label multiple dose escalation study to evaluate the safety and tolerability of KZR-616 in patients with systemic lupus erythematosus (SLE) with and without nephritis. Part 2, the Phase 2, is a randomized, placebo-controlled, double-blind study to evaluate the safety and efficacy of KZR-616 in patients with active proliferative lupus nephritis (LN).",null,"A Phase 1b/2 Study of KZR-616 in Patients With Systemic Lupus Erythematosus With and Without Nephritis","KZR-616-002","Systemic Lupus Erythematosus\nLupus Nephritis","Lupus Erythematosus|Lupus Erythematosus, Systemic|Erythema|Lupus Nephritis|Nephritis","Connective Tissue Diseases|Dermatological Diseases|Urologic Diseases","Derm & Connective Tissue Disorders|Reproductive and Urogenital","Experimental|Placebo Comparator","KZR-616 Dose Level 1 + standard therapy|KZR-616 Dose Level 2 + standard therapy|Placebo + standard therapy","1 of 2 dose levels of KZR-616 selected based on data from the Phase 1 dose escalation and administered in combination with Mycophenolate Mofetil and prednisone|Placebo administered with Mycophenolate Mofetil and prednisone","Drug","KZR-616|Placebo","Subcutaneous Injection of KZR-616|Subcutaneous injection of matching placebo",null,"KZR-616 Dose Level 1 + standard therapy|KZR-616 Dose Level 2 + standard therapy|Placebo + standard therapy","\n\nPHASE 1:\n\n 1. Body Mass Index (BMI) of 18-35 kg/m2\n 2. Fulfils the 2012 Systemic Lupus International Collaborating Clinics (SLICC) classification criteria for SLE\n 3. Have at least one of the following at screening per central lab: 1. Positive antinuclear antibody (ANA) test (1:40 or higher); or\n     2. Anti-double stranded deoxynucleic acid (dsDNA) antibodies elevated to above normal; or\n     3. Anti-Smith antibody elevated to above normal (i.e., positive or equivocal results)\n    \n    \n 4. Active SLE as indicated by a SLEDAI-2K total score â‰¥ 4 at screening\n 5. Must have received 1 or more therapies for SLE\n 6. Acceptable screening laboratory values of concern, including: 1. Adequate hematologic criteria:\n     2. Adequate hepatic function:\n     3. Pancreatic enzymes\n     4. eGFR â‰¥ 50 mL/min/1.73 m2 (estimated based on Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula)\n     5. IgG â‰¥ 500 mg/dL\n    \n    \n 7. If taking the following SLE therapies: 1. Oral glucocorticoids (up to 20 mg/day prednisone or equivalent): must be on a stable dosage regimen of oral corticosteroid at least 4 weeks prior to screening\n     2. Hydroxychloroquine (â‰¤ 400 mg/day) or chloroquine (â‰¤ 500 mg/day) or other anti-malarials: must be started or stopped at least 12 weeks prior to screening, with stable dosage regimen for at least 4 weeks prior to screening\n     3. Immunosuppressive agents: must be started or stopped at least 12 weeks prior to screening, with stable dosage regimen for at least 4 weeks prior to screening: * Mycophenolate mofetil (â‰¤ 3 g/day) or mycophenolic acid (â‰¤ 2.16 g/day)\n         * Azathioprine (â‰¤ 200 mg/day)\n         * Methotrexate (â‰¤ 25 mg/week)\n         * Leflunomide (â‰¤ 20 mg/day)\n        \n        \n    \n    \n\nPHASE 2:\n\n 1. BMI of 18-35 kg/m2\n 2. Fulfils the 2012 Systemic Lupus International Collaborating Clinics (SLICC) classification criteria for SLE.\n 3. Undergoing an ACR-recommended MMF- or MPA-based induction therapy regimen for lupus nephritis for 1-3 months, and willing to continue at least the MMF/MPA portion of the regimen unaltered throughout the duration of the study. Must be receiving a stable regimen of oral glucocorticoids for at least 2 weeks prior to screening\n 4. The patient has at least one of the following at screening per central lab: 1. Positive ANA test (1:40 or higher) or\n     2. anti-dsDNA antibodies elevated to above normal (including indeterminate and positive results); or\n     3. anti-Smith antibody at screening elevated to above normal (i.e., positive or equivocal results)\n    \n    \n 5. Kidney biopsy within 6 months prior to screening with a histologic diagnosis of LN (International Society of Nephrology/Renal Pathology Society 2003 classification of lupus nephritis [ISN/RPS]) Classes III, IV-S or IV-G, (A) or (A/C); Patients with isolated Class V LN will not be permitted on study but patients with Class III or IV and concomitant Class V will be permitted provided their UPCR meets the criterion set below (NOTE: Patients meeting all inclusion criteria with a kidney biopsy of greater than 6 months will be allowed following a repeat biopsy prior to study entry.)\n 6. UPCR of â‰¥ 1.0 in 24-hour urine collection in patients with active LN of ISN/RPS class III or IV, Â±V (UPCR â‰¥ 2.0 if concomitant with class V)\n 7. Acceptable screening laboratory values of concern, including: 1. Adequate hematologic criteria:\n     2. Adequate hepatic function:\n     3. Pancreatic enzymes\n     4. eGFR â‰¥ 50 mL/min/1.73 m2 estimated based on CKD-EPI formula\n     5. IgG â‰¥ 500 mg/dL\n    \n    \n\n","\n\nPHASE 1:\n\n 1. Active central nervous system involvement by autoimmune disease\n 2. Receipt of any of the following treatments within the following timeframes before screening 1. Glucocorticoids â‰¥ 100 mg prednisone or equivalent: 4 weeks\n     2. Intravenous Immunoglobulin (IVIg): 4 weeks\n     3. Other non-biologic immunosuppressive agents, such as cyclosporine, tacrolimus: 4 weeks\n     4. Cyclophosphamide: 12 weeks\n     5. Cytokine antagonists: 12 weeks\n     6. B-cell-depleting therapies (e.g., rituximab): 24 weeks\n     7. Other biologics or investigational drugs: 8 weeks or 5 half-lives, whichever is longer\n     8. Transfusion with blood, packed red blood cells, platelets or treatment with plasmapheresis or plasma exchange: 6 weeks\n    \n    \n 3. Patient has had recent serious or ongoing infection, or risk for serious infection\n 4. History of cancer (except for in situ cancer, excised, or limited stage, curatively treated cancer with no sign of disease for > 5 years)\n 5. Major surgery within 4 weeks before signing the informed consent form (ICF) or major surgery planned during the study period\n\nPHASE 2:\n\n 1.  Active central nervous system involvement by autoimmune disease\n 2.  Isolated Class V membranous LN on a renal biopsy obtained within 6 months prior to signing ICF or during the screening period\n 3.  Known intolerance to MMF or mycophenolic acid\n 4.  History of dialysis within 12 months prior to signing the ICF or expected need for renal replacement therapy (dialysis or renal transplant) within a 6-month period after enrollment\n 5.  History of Rapidly Progressive Glomerulonephritis (RPGN) and/or other renal disease\n 6.  History of chronic kidney disease not directly due to LN\n 7.  Hypertension (Unable to maintain blood pressure with a systolic blood pressure of < 140 mmHg and a diastolic blood pressure of < 90 mmHg at rest)o If currently on RAS blockade (ACEI, ARB, direct renin inhibitors), dose must be stable for at least 4 weeks prior to screening\n     \n     \n 8.  Receipt of any of the following treatments within the following timeframes before first day of study treatment: 1. IVIg: 4 weeks\n      2. Glucocorticoids â‰¥ 1 g/day prednisone or equivalent: 4 weeks\n      3. Intra-articular therapies, such as corticosteroids: 4 weeks\n      4. Conventional disease-modifying antirheumatic drugs, including methotrexate, leflunomide, sulfasalazine, cyclosporine, tacrolimus: 12 weeks\n      5. MMF of â‰¥ 3 g (or 2.16 g of MPA) for â‰¥ 1 month, cyclophosphamide: 24 weeks\n      6. Cytokine antagonists: 12 weeks\n      7. B-cell-depleting therapies (e.g., rituximab): 24 weeks\n      8. Other biologics or investigational drugs: 8 weeks or 5 half-lives, whichever is longer\n     \n     \n 9.  Major surgery within 4 weeks before signing the ICF or major surgery planned during the study period\n 10. Patient has had recent serious or ongoing infection, or risk for serious infection\n 11. Clinical evidence of significant unstable or uncontrolled acute or chronic diseases\n 12. History of cancer (except for in situ cancer, excised, or limited stage, curatively treated cancer with no sign of disease for > 5 years)","EGFR","epidermal growth factor receptor","Protein","Ovary, Breast, Lung","Actual","2018-01-08","Actual","Anticipated","2020-05-01","Anticipated","2018-03-01","2017-12-21","2018-01-04","2018-03-07","Yes","immunoproteasome inhibition\nselective proteasome inhibition\nproteasome","Interventional","Treatment","Sequential Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years","70 Years","All",null,"No","Undecided",{"$nulls":3},"Yes","No",{"$nulls":19},"Phase 1 and Phase 2: Safety and Tolerability assessed by monitoring incidence and severity of adverse events","Baseline through 25 weeks",null,"Phase 1: Identify Recommended Phase 2 dose levels (RP2Ds) of KZR-616|Phase 1: Peak plasma concentration (Cmax) following injection with KZR-616|Phase 1: Time to peak plasma concentration (Tmax) of KZR-616|Phase 1: Area under the plasma concentration versus time curve (AUC) of KZR-616|Phase 1: Half-life of KZR-616 (T1/2)|Phase 2: The number of patients with a 50% reduction in urine protein to creatinine ratio (UPCR)|Phase 2: The number of patients with a complete renal response|Phase 2: Change from baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K)|Phase 2: Change from baseline in British Isles Lupus Assessment Group (BILAG) score|Phase 2: Change from baseline in Levels of Autoantibodies (ANA and anti-dsDNA) and Complement (C3 and C4)|Phase 2: Change from baseline in UPCR|Phase 2: Change from baseline in eGFR|Phase 2: Change from baseline in daily glucocorticoid use|Other Pre-specified Outcome Measures:|Phase 1 and 2: Inhibition of chymotrypsin-like (CT-L) activity in whole blood and peripheral blood mononuclear cells (PBMCs);|Phase 1 and 2: Assessment of proteasome sub-unit occupancy in whole blood and PBMCs","Determined through assessment of all AEs and any dose limiting toxicities (DLTs)|Day 1|Day 29|Baseline and every 4 weeks through 25 weeks|UPCR of â‰¤ 0.5; estimated Glomerular Filtration Rate (eGFR) of â‰¥ 60 mL/min or no worsening of eGFR from baseline of > 20%; No discontinuation of investigational product or use of restricted medication beyond the protocol-allowed thresholds from Days 1 to 85|Other Pre-specified Outcome Measures:","4 weeks|Every 4 weeks through 25 weeks","dbomba@kezarbio.com","Director of Clinical Operations","650 822-5617","Thousand Oaks, California, United States, 91360|Debary, Florida, United States, 32713 Kzr Research SiteMiami, Florida, United States, 33136 Kzr Research SiteMiami, Florida, United States, 33165 Kzr Research SiteOrlando, Florida, United States, 32810 Kzr Research SitePalm Harbor, Florida, United States, 34684 Kzr Research SiteTampa, Florida, United States, 33613 Kzr Research SiteWinter Park, Florida, United States, 32789|Memphis, Tennessee, United States, 38119|Houston, Texas, United States, 77034 Kzr Research SiteHouston, Texas, United States, 77084","California|Florida|Tennessee|Texas","United States","Kzr Research Site",{"$nulls":3},"Kezar","2018-03-07","2020-05-25T16:35:40.004","2020-05-26T17:10:42.972","NCT03393013"]
["5ecbf3dbe2561b1b11905cd8","NCT03393013","2018-05-30","Kezar Life Sciences","KZR","Recruiting","A Study of KZR-616 in Patients With Systemic Lupus Erythematosus With and Without Nephritis","Kzr-616","Proteasome Inhibitor","Yes","['Kzr-616']","No",null,"Phase 1/Phase 2",3,72,"Anticipated","2018-03-07","2020-02-01",{"$nulls":5},"This is a Phase 1b/2, multi-center study in which patients will receive KZR-616, administered as a subcutaneous injection weekly for 13 weeks.\n\nThe study consists of 2 parts. Part 1, the Phase 1b, is an open-label multiple dose escalation study to evaluate the safety and tolerability of KZR-616 in patients with systemic lupus erythematosus (SLE) with and without nephritis. Part 2, the Phase 2, is a randomized, placebo-controlled, double-blind study to evaluate the safety and efficacy of KZR-616 in patients with active proliferative lupus nephritis (LN).",null,"A Phase 1b/2 Study of KZR-616 in Patients With Systemic Lupus Erythematosus With and Without Nephritis","KZR-616-002","Systemic Lupus Erythematosus\nLupus Nephritis","Lupus Erythematosus|Lupus Erythematosus, Systemic|Erythema|Lupus Nephritis|Nephritis","Connective Tissue Diseases|Dermatological Diseases|Urologic Diseases","Derm & Connective Tissue Disorders|Reproductive and Urogenital","Experimental|Placebo Comparator","KZR-616 Dose Level 1 + standard therapy|KZR-616 Dose Level 2 + standard therapy|Placebo + standard therapy","1 of 2 dose levels of KZR-616 selected based on data from the Phase 1 dose escalation and administered in combination with Mycophenolate Mofetil and prednisone|Placebo administered with Mycophenolate Mofetil and prednisone","Drug","KZR-616|Placebo","Subcutaneous Injection of KZR-616|Subcutaneous injection of matching placebo",null,"KZR-616 Dose Level 1 + standard therapy|KZR-616 Dose Level 2 + standard therapy|Placebo + standard therapy","\n\nPHASE 1:\n\n 1. Body Mass Index (BMI) of 18-35 kg/m2\n 2. Fulfils the 2012 Systemic Lupus International Collaborating Clinics (SLICC) classification criteria for SLE\n 3. Have at least one of the following at screening per central lab: 1. Positive antinuclear antibody (ANA) test (1:40 or higher); or\n     2. Anti-double stranded deoxynucleic acid (dsDNA) antibodies elevated to above normal; or\n     3. Anti-Smith antibody elevated to above normal (i.e., positive or equivocal results)\n    \n    \n 4. Active SLE as indicated by a SLEDAI-2K total score â‰¥ 4 at screening\n 5. Must have received 1 or more therapies for SLE\n 6. Acceptable screening laboratory values of concern, including: 1. Adequate hematologic criteria:\n     2. Adequate hepatic function:\n     3. Pancreatic enzymes\n     4. eGFR â‰¥ 50 mL/min/1.73 m2 (estimated based on Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula)\n     5. IgG â‰¥ 500 mg/dL\n    \n    \n 7. If taking the following SLE therapies: 1. Oral glucocorticoids (up to 20 mg/day prednisone or equivalent): must be on a stable dosage regimen of oral corticosteroid at least 4 weeks prior to screening\n     2. Hydroxychloroquine (â‰¤ 400 mg/day) or chloroquine (â‰¤ 500 mg/day) or other anti-malarials: must be started or stopped at least 12 weeks prior to screening, with stable dosage regimen for at least 4 weeks prior to screening\n     3. Immunosuppressive agents: must be started or stopped at least 12 weeks prior to screening, with stable dosage regimen for at least 4 weeks prior to screening: * Mycophenolate mofetil (â‰¤ 3 g/day) or mycophenolic acid (â‰¤ 2.16 g/day)\n         * Azathioprine (â‰¤ 200 mg/day)\n         * Methotrexate (â‰¤ 25 mg/week)\n         * Leflunomide (â‰¤ 20 mg/day)\n        \n        \n    \n    \n\nPHASE 2:\n\n 1. BMI of 18-35 kg/m2\n 2. Fulfils the 2012 Systemic Lupus International Collaborating Clinics (SLICC) classification criteria for SLE.\n 3. Undergoing an ACR-recommended MMF- or MPA-based induction therapy regimen for lupus nephritis for 1-3 months, and willing to continue at least the MMF/MPA portion of the regimen unaltered throughout the duration of the study. Must be receiving a stable regimen of oral glucocorticoids for at least 2 weeks prior to screening\n 4. The patient has at least one of the following at screening per central lab: 1. Positive ANA test (1:40 or higher) or\n     2. anti-dsDNA antibodies elevated to above normal (including indeterminate and positive results); or\n     3. anti-Smith antibody at screening elevated to above normal (i.e., positive or equivocal results)\n    \n    \n 5. Kidney biopsy within 6 months prior to screening with a histologic diagnosis of LN (International Society of Nephrology/Renal Pathology Society 2003 classification of lupus nephritis [ISN/RPS]) Classes III, IV-S or IV-G, (A) or (A/C); Patients with isolated Class V LN will not be permitted on study but patients with Class III or IV and concomitant Class V will be permitted provided their UPCR meets the criterion set below (NOTE: Patients meeting all inclusion criteria with a kidney biopsy of greater than 6 months will be allowed following a repeat biopsy prior to study entry.)\n 6. UPCR of â‰¥ 1.0 in 24-hour urine collection in patients with active LN of ISN/RPS class III or IV, Â±V (UPCR â‰¥ 2.0 if concomitant with class V)\n 7. Acceptable screening laboratory values of concern, including: 1. Adequate hematologic criteria:\n     2. Adequate hepatic function:\n     3. Pancreatic enzymes\n     4. eGFR â‰¥ 50 mL/min/1.73 m2 estimated based on CKD-EPI formula\n     5. IgG â‰¥ 500 mg/dL\n    \n    \n\n","\n\nPHASE 1:\n\n 1. Active central nervous system involvement by autoimmune disease\n 2. Receipt of any of the following treatments within the following timeframes before screening 1. Glucocorticoids â‰¥ 100 mg prednisone or equivalent: 4 weeks\n     2. Intravenous Immunoglobulin (IVIg): 4 weeks\n     3. Other non-biologic immunosuppressive agents, such as cyclosporine, tacrolimus: 4 weeks\n     4. Cyclophosphamide: 12 weeks\n     5. Cytokine antagonists: 12 weeks\n     6. B-cell-depleting therapies (e.g., rituximab): 24 weeks\n     7. Other biologics or investigational drugs: 8 weeks or 5 half-lives, whichever is longer\n     8. Transfusion with blood, packed red blood cells, platelets or treatment with plasmapheresis or plasma exchange: 6 weeks\n    \n    \n 3. Patient has had recent serious or ongoing infection, or risk for serious infection\n 4. History of cancer (except for in situ cancer, excised, or limited stage, curatively treated cancer with no sign of disease for > 5 years)\n 5. Major surgery within 4 weeks before signing the informed consent form (ICF) or major surgery planned during the study period\n\nPHASE 2:\n\n 1.  Active central nervous system involvement by autoimmune disease\n 2.  Isolated Class V membranous LN on a renal biopsy obtained within 6 months prior to signing ICF or during the screening period\n 3.  Known intolerance to MMF or mycophenolic acid\n 4.  History of dialysis within 12 months prior to signing the ICF or expected need for renal replacement therapy (dialysis or renal transplant) within a 6-month period after enrollment\n 5.  History of Rapidly Progressive Glomerulonephritis (RPGN) and/or other renal disease\n 6.  History of chronic kidney disease not directly due to LN\n 7.  Hypertension (Unable to maintain blood pressure with a systolic blood pressure of < 140 mmHg and a diastolic blood pressure of < 90 mmHg at rest)o If currently on RAS blockade (ACEI, ARB, direct renin inhibitors), dose must be stable for at least 4 weeks prior to screening\n     \n     \n 8.  Receipt of any of the following treatments within the following timeframes before first day of study treatment: 1. IVIg: 4 weeks\n      2. Glucocorticoids â‰¥ 1 g/day prednisone or equivalent: 4 weeks\n      3. Intra-articular therapies, such as corticosteroids: 4 weeks\n      4. Conventional disease-modifying antirheumatic drugs, including methotrexate, leflunomide, sulfasalazine, cyclosporine, tacrolimus: 12 weeks\n      5. MMF of â‰¥ 3 g (or 2.16 g of MPA) for â‰¥ 1 month, cyclophosphamide: 24 weeks\n      6. Cytokine antagonists: 12 weeks\n      7. B-cell-depleting therapies (e.g., rituximab): 24 weeks\n      8. Other biologics or investigational drugs: 8 weeks or 5 half-lives, whichever is longer\n     \n     \n 9.  Major surgery within 4 weeks before signing the ICF or major surgery planned during the study period\n 10. Patient has had recent serious or ongoing infection, or risk for serious infection\n 11. Clinical evidence of significant unstable or uncontrolled acute or chronic diseases\n 12. History of cancer (except for in situ cancer, excised, or limited stage, curatively treated cancer with no sign of disease for > 5 years)","EGFR","epidermal growth factor receptor","Protein","Ovary, Breast, Lung","Actual","2018-01-08","Actual","Anticipated","2020-05-01","Anticipated","2018-05-01","2017-12-21","2018-01-04","2018-05-25","Yes","immunoproteasome inhibition\nselective proteasome inhibition\nproteasome","Interventional","Treatment","Sequential Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years","70 Years","All",null,"No","Undecided",{"$nulls":3},"Yes","No",{"$nulls":19},"Phase 1 and Phase 2: Safety and Tolerability assessed by monitoring incidence and severity of adverse events","Baseline through 25 weeks",null,"Phase 1: Identify Recommended Phase 2 dose levels (RP2Ds) of KZR-616|Phase 1: Peak plasma concentration (Cmax) following injection with KZR-616|Phase 1: Time to peak plasma concentration (Tmax) of KZR-616|Phase 1: Area under the plasma concentration versus time curve (AUC) of KZR-616|Phase 1: Half-life of KZR-616 (T1/2)|Phase 2: The number of patients with a 50% reduction in urine protein to creatinine ratio (UPCR)|Phase 2: The number of patients with a complete renal response|Phase 2: Change from baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K)|Phase 2: Change from baseline in British Isles Lupus Assessment Group (BILAG) score|Phase 2: Change from baseline in Levels of Autoantibodies (ANA and anti-dsDNA) and Complement (C3 and C4)|Phase 2: Change from baseline in UPCR|Phase 2: Change from baseline in eGFR|Phase 2: Change from baseline in daily glucocorticoid use|Other Pre-specified Outcome Measures:|Phase 1 and 2: Inhibition of chymotrypsin-like (CT-L) activity in whole blood and peripheral blood mononuclear cells (PBMCs);|Phase 1 and 2: Assessment of proteasome sub-unit occupancy in whole blood and PBMCs","Determined through assessment of all AEs and any dose limiting toxicities (DLTs)|Day 1|Day 29|Baseline and every 4 weeks through 25 weeks|UPCR of â‰¤ 0.5; estimated Glomerular Filtration Rate (eGFR) of â‰¥ 60 mL/min or no worsening of eGFR from baseline of > 20%; No discontinuation of investigational product or use of restricted medication beyond the protocol-allowed thresholds from Days 1 to 85|Other Pre-specified Outcome Measures:","4 weeks|Every 4 weeks through 25 weeks","dbomba@kezarbio.com","Director of Clinical Operations","650 822-5617","Parkville, Victoria, Australia, 3052|Thousand Oaks, California, United States, 91360 Kzr Research SiteUpland, California, United States, 91786|Debary, Florida, United States, 32713 Kzr Research SiteMiami, Florida, United States, 33136 Kzr Research SiteMiami, Florida, United States, 33165 Kzr Research SiteOrlando, Florida, United States, 32810 Kzr Research SitePalm Harbor, Florida, United States, 34684 Kzr Research SiteTampa, Florida, United States, 33613 Kzr Research SiteWinter Park, Florida, United States, 32789|Great Neck, New York, United States, 11021 Kzr Research SiteManhasset, New York, United States, 11030 Kzr Research SiteRochester, New York, United States, 14642|Columbus, Ohio, United States, 43210|Memphis, Tennessee, United States, 38119|Houston, Texas, United States, 77034 Kzr Research SiteHouston, Texas, United States, 77084","California|Florida|New York|Ohio|Tennessee|Texas","Australia|United States","Victoria Kzr Research Site|Kzr Research Site",{"$nulls":3},"Kezar","2018-05-25","2020-05-25T16:35:39.546","2020-05-26T17:10:42.972","NCT03393013"]
["5ecbf3dc11702c1b1b9169f0","NCT03393013","2018-08-07","Kezar Life Sciences","KZR","Recruiting","A Study of KZR-616 in Patients With Systemic Lupus Erythematosus With and Without Nephritis","Kzr-616","Proteasome Inhibitor","Yes","['Kzr-616']","No",null,"Phase 1/Phase 2",3,72,"Anticipated","2018-03-07","2020-02-01",{"$nulls":5},"This is a Phase 1b/2, multi-center study in which patients will receive KZR-616, administered as a subcutaneous injection weekly for 13 weeks.\n\nThe study consists of 2 parts. Part 1, the Phase 1b, is an open-label multiple dose escalation study to evaluate the safety and tolerability of KZR-616 in patients with systemic lupus erythematosus (SLE) with and without nephritis. Part 2, the Phase 2, is a randomized, placebo-controlled, double-blind study to evaluate the safety and efficacy of KZR-616 in patients with active proliferative lupus nephritis (LN).",null,"A Phase 1b/2 Study of KZR-616 in Patients With Systemic Lupus Erythematosus With and Without Nephritis","KZR-616-002","Systemic Lupus Erythematosus\nLupus Nephritis","Lupus Erythematosus|Lupus Erythematosus, Systemic|Erythema|Lupus Nephritis|Nephritis","Connective Tissue Diseases|Dermatological Diseases|Urologic Diseases","Derm & Connective Tissue Disorders|Reproductive and Urogenital","Experimental|Placebo Comparator","KZR-616 Dose Level 1 + standard therapy|KZR-616 Dose Level 2 + standard therapy|Placebo + standard therapy","1 of 2 dose levels of KZR-616 selected based on data from the Phase 1 dose escalation and administered in combination with Mycophenolate Mofetil and prednisone|Placebo administered with Mycophenolate Mofetil and prednisone","Drug","KZR-616|Placebo","Subcutaneous Injection of KZR-616|Subcutaneous injection of matching placebo",null,"KZR-616 Dose Level 1 + standard therapy|KZR-616 Dose Level 2 + standard therapy|Placebo + standard therapy","\n\nPHASE 1:\n\n 1. Body Mass Index (BMI) of 18-40 kg/m2\n 2. Fulfils the 2012 Systemic Lupus International Collaborating Clinics (SLICC) classification criteria for SLE\n 3. Have at least one of the following at screening per central lab: 1. Positive antinuclear antibody (ANA) test (1:80 or higher); or\n     2. Anti-double stranded deoxyribonucleic acid (dsDNA) antibodies elevated to above normal (i.e. positive results); or\n     3. Anti-Smith antibody elevated to above normal (i.e., positive results)\n    \n    \n 4. Active SLE as indicated by a Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) total score â‰¥ 4 at screening\n 5. Must have received 1 or more therapies for SLE\n 6. Acceptable screening laboratory values of concern, including: 1. Adequate hematologic criteria:\n     2. Adequate hepatic function:\n     3. Pancreatic enzymes\n     4. eGFR â‰¥ 40 mL/min/1.73 m2 (estimated based on Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula)\n     5. IgG â‰¥ 500 mg/dL\n    \n    \n 7. If taking the following SLE therapies: 1. Oral glucocorticoids (up to 20 mg/day prednisone or equivalent): must be on a stable dosage regimen of oral corticosteroid at least 4 weeks prior to screening\n     2. Hydroxychloroquine (â‰¤ 400 mg/day) or chloroquine (â‰¤ 500 mg/day) orally or other anti-malarials: must be started or stopped at least 12 weeks prior to screening, with stable dosage regimen for at least 4 weeks prior to screening\n     3. Immunosuppressive agents: must be started or stopped at least 12 weeks prior to screening, with stable dosage regimen, including route of administration, for at least 4 weeks prior to screening: * Mycophenolate mofetil (â‰¤ 3 g/day) or mycophenolic acid (â‰¤ 2.16 g/day) orally\n         * Azathioprine (â‰¤ 200 mg/day) orally\n         * Methotrexate (â‰¤ 25 mg/week) orally, SC, or intramuscularly (patients must be onconcmitant folic or folinic acid supplementation if using methotrexate)\n         * Leflunomide (â‰¤ 20 mg/day) orally\n        \n        \n    \n    \n\nPHASE 2:\n\n 1. BMI of 18-40 kg/m2\n 2. Fulfils the 2012 Systemic Lupus International Collaborating Clinics (SLICC) classification criteria for SLE.\n 3. Undergoing an ACR-recommended MMF- or MPA-based induction therapy regimen for lupus nephritis for 4 to 12 weeks, and willing to continue at least the MMF/MPA portion of the regimen unaltered throughout the duration of the study. Must be receiving a stable regimen of oral corticosteroids for at least 2 weeks prior to screening\n 4. The patient has at least one of the following at screening per central lab: 1. Positive ANA test (1:40 or higher) or\n     2. Anti-dsDNA antibodies elevated to above normal (i.e., positive results); or\n     3. Anti-Smith antibody at screening elevated to above normal (i.e., positive results)\n    \n    \n 5. Kidney biopsy within 26 weeks prior to randomization with a histologic diagnosis of LN (International Society of Nephrology/Renal Pathology Society 2003 classification of lupus nephritis [ISN/RPS]) Classes III, IV-S or IV-G, (A) or (A/C); Patients with Class III or IV and concomitant Class V will be permitted (NOTE: Patients meeting all inclusion criteria with a kidney biopsy of greater than 26 weeks will be allowed following a repeat biopsy which shows the necessary histologic diagnosis prior to study entry.)\n 6. UPCR of â‰¥ 1.0 in 24-hour urine collection\n 7. Acceptable screening laboratory values of concern, including: 1. Adequate hematologic criteria:\n     2. Adequate hepatic function:\n     3. Pancreatic enzymes\n     4. eGFR â‰¥ 40 mL/min/1.73 m2 estimated based on CKD-EPI formula\n     5. IgG â‰¥ 500 mg/dL\n    \n    \n\n","\n\nPHASE 1:\n\n 1. Active central nervous system involvement by autoimmune disease requiring specific therapeutic intervention within 60 days prior to first day of study treatment\n 2. Fulfills diagnostic criteria for another rheumatic (overlap) disease that may confound clincal assessments in the study\n 3. History of severe antiphospholipid syndrome within 12 months of screening or not on an adequate anticoagulation regimen.\n 4. Receipt of any of the following treatments within the following timeframes before screening 1.  Systemic corticosteroids â‰¥ 100 mg prednisone or equivalent: 4 weeks\n     2.  Intra-articular therapies, such as corticosteroids or hyaluronic acid preparations: 4 weeks\n     3.  Intravenous Immunoglobulin (IVIg): 4 weeks\n     4.  Other non-biologic immunosuppressive agents, such as cyclosporine, tacrolimus: 4 weeks\n     5.  Cyclophosphamide: 12 weeks\n     6.  Cytokine antagonists: 12 weeks\n     7.  B-cell-depleting therapies (e.g., rituximab): 24 weeks\n     8.  Belimumab, abatacept, or atacicept: 12 weeks\n     9.  Other biologics or investigational drugs: 8 weeks or 5 half-lives, whichever is longer\n     10. Transfusion with blood, packed red blood cells, platelets or treatment with plasmapheresis or plasma exchange: 6 weeks\n    \n    \n 5. Patient has had recent serious or ongoing infection, or risk for serious infection\n 6. History of any concurrent illness that has required treatment with oral or parenteral corticosteroids for more than a total of 2 weeks within the last 24 weeks prior to signing the ICF\n 7. Clinical evidence of significant unstable or uncontrolled acute or chronic diseases\n 8. History of cancer, except for in situ cancer that has been completely excised or has been curatively treated cancer with no sign of disease for > 5 years\n 9. Major surgery within 4 weeks before signing the ICF or major surgery planned during the study period\n\nPHASE 2:\n\n 1.  Active central nervous system involvement by autoimmune disease\n 2.  Isolated Class V membranous LN on a renal biopsy obtained within 26 weeks prior to signing ICF or during the screening period\n 3.  Known intolerance to MMF or MPA\n 4.  History of dialysis within 12 months prior to signing the ICF or expected need for renal replacement therapy (dialysis or renal transplant) within a 6-month period after enrollment\n 5.  History of Rapidly Progressive Glomerulonephritis (RPGN) and/or other renal disease\n 6.  History of chronic kidney disease not directly due to LN\n 7.  Uncontrolled blood pressure (systolic blood pressure â‰¥140 mmHg and diastolic blood pressure â‰¥90 mmHg at rest)o If currently on RAS blockade (ACE-I, ARB, direct renin inhibitors), dose must be stable for at least 4 weeks prior to screening\n     \n     \n 8.  Receipt of any of the following treatments within the following timeframes before first day of study treatment: 1.  IVIg: 4 weeks\n      2.  Corticosteroids â‰¥ 1 g/day prednisone or equivalent: 4 weeks\n      3.  Intra-articular therapies, such as corticosteroids or hyaluronic acid preparations: 4 weeks\n      4.  Conventional disease-modifying antirheumatic drugs, including methotrexate, leflunomide, sulfasalazine, cyclosporine, tacrolimus: 12 weeks\n      5.  MMF of â‰¥ 3 g (or 2.16 g of MPA) for â‰¥ 4 weeks, cyclophosphamide: 24 weeks\n      6.  Cytokine antagonists: 12 weeks\n      7.  B-cell-depleting therapies (e.g., rituximab): 24 weeks\n      8.  Other biologics or investigational drugs: 8 weeks or 5 half-lives, whichever is longer\n      9.  Hydroxychloroquine (>400 mg/day) or chloroquine (>500 mg/day) or other antimalarials above the recommended dose. Antimalarials, if used, must have been started or stopped at least 12 weeks prior to first dose, with stable dosage regimen for at least 4 weeks prior to first dose of study treatment\n      10. Abatacept: 12 weeks\n     \n     \n 9.  Major surgery within 4 weeks before signing the ICF or major surgery planned during the study period\n 10. History of any other concurrent illness that has required treatment with oral or parenteral corticosteroids for more than a total of 2 weeks within the last 24 weeks prior to signing the ICF\n 11. Patient has had recent serious or ongoing infection, or risk for serious infection\n 12. Clinical evidence of significant unstable or uncontrolled acute or chronic diseases\n 13. History of cancer, except for in situ cancer that has been completely excised or has been curatively treated with no sign of disease for > 5 years","EGFR","epidermal growth factor receptor","Protein","Ovary, Breast, Lung","Actual","2018-01-08","Actual","Anticipated","2020-05-01","Anticipated","2018-08-01","2017-12-21","2018-01-04","2018-08-03","Yes","immunoproteasome inhibition\nselective proteasome inhibition\nproteasome","Interventional","Treatment","Sequential Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years","75 Years","All",null,"No","Undecided",{"$nulls":3},"Yes","No",{"$nulls":19},"Phase 1 and Phase 2: Safety and Tolerability assessed by monitoring incidence and severity of adverse events","Baseline through 25 weeks",null,"Phase 1: Identify Recommended Phase 2 dose levels (RP2Ds) of KZR-616|Phase 1: Peak plasma concentration (Cmax) following injection with KZR-616|Phase 1: Time to peak plasma concentration (Tmax) of KZR-616|Phase 1: Area under the plasma concentration versus time curve (AUC) of KZR-616|Phase 1: Half-life of KZR-616 (T1/2)|Phase 2: The number of patients with a 50% reduction in urine protein to creatinine ratio (UPCR)|Phase 2: The number of patients with a complete renal response|Phase 2: Change from baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K)|Phase 2: Change from baseline in British Isles Lupus Assessment Group (BILAG) score|Phase 2: Change from baseline in Levels of Autoantibodies (ANA and anti-dsDNA) and Complement (C3 and C4)|Phase 2: Change from baseline in UPCR|Phase 2: Change from baseline in eGFR|Phase 2: Change from baseline in daily glucocorticoid use|Other Pre-specified Outcome Measures:|Phase 1 and 2: Inhibition of chymotrypsin-like (CT-L) activity in whole blood and peripheral blood mononuclear cells (PBMCs);|Phase 1 and 2: Assessment of proteasome sub-unit occupancy in whole blood and PBMCs","Determined through assessment of all AEs and any dose limiting toxicities (DLTs)|Day 1|Day 29|Baseline and every 4 weeks through 25 weeks|UPCR of â‰¤ 0.5; estimated Glomerular Filtration Rate (eGFR) of â‰¥ 60 mL/min or no worsening of eGFR from baseline of > 20%; No discontinuation of investigational product or use of restricted medication beyond the protocol-allowed thresholds from Days 1 to 85|Other Pre-specified Outcome Measures:","4 weeks|Every 4 weeks through 25 weeks","dbomba@kezarbio.com","Director of Clinical Operations","650 822-5617","Parkville, Victoria, Australia, 3052|Bucaramanga, Santander, Colombia|Thousand Oaks, California, United States, 91360 Kzr Research SiteUpland, California, United States, 91786|Debary, Florida, United States, 32713 Kzr Research SiteMiami, Florida, United States, 33136 Kzr Research SiteMiami, Florida, United States, 33165 Kzr Research SiteOrlando, Florida, United States, 32810 Kzr Research SitePalm Harbor, Florida, United States, 34684 Kzr Research SiteTampa, Florida, United States, 33613 Kzr Research SiteWinter Park, Florida, United States, 32789|Great Neck, New York, United States, 11021 Kzr Research SiteManhasset, New York, United States, 11030 Kzr Research SiteRochester, New York, United States, 14642|Columbus, Ohio, United States, 43210|Memphis, Tennessee, United States, 38119|Houston, Texas, United States, 77034 Kzr Research SiteHouston, Texas, United States, 77084","California|Florida|New York|Ohio|Tennessee|Texas","Australia|Colombia|United States","Victoria Kzr Research Site|Santander Kzr Research Site|Kzr Research Site",{"$nulls":3},"Kezar","2018-08-03","2020-05-25T16:35:40.004","2020-05-26T17:10:42.972","NCT03393013"]
["5ecbf3dce2561b1b11905cd9","NCT03393013","2019-03-26","Kezar Life Sciences","KZR","Recruiting","A Study of KZR-616 in Patients With Systemic Lupus Erythematosus With and Without Nephritis","Kzr-616","Proteasome Inhibitor","Yes","['Kzr-616']","No",null,"Phase 1/Phase 2",3,72,"Anticipated","2018-03-07","2020-02-01",{"$nulls":5},"This is a Phase 1b/2, multi-center study in which patients will receive KZR-616, administered as a subcutaneous injection weekly for 13 weeks.\n\nThe study consists of 2 parts. Part 1, the Phase 1b, is an open-label multiple dose escalation study to evaluate the safety and tolerability of KZR-616 in patients with systemic lupus erythematosus (SLE) with and without nephritis. Part 2, the Phase 2, is a randomized, placebo-controlled, double-blind study to evaluate the safety and efficacy of KZR-616 in patients with active proliferative lupus nephritis (LN).",null,"A Phase 1b/2 Study of KZR-616 in Patients With Systemic Lupus Erythematosus With and Without Nephritis","KZR-616-002","Systemic Lupus Erythematosus\nLupus Nephritis","Lupus Erythematosus|Lupus Erythematosus, Systemic|Erythema|Lupus Nephritis|Nephritis","Connective Tissue Diseases|Dermatological Diseases|Urologic Diseases","Derm & Connective Tissue Disorders|Reproductive and Urogenital","Experimental|Placebo Comparator","KZR-616 Dose Level 1 + standard therapy|KZR-616 Dose Level 2 + standard therapy|Placebo + standard therapy","1 of 2 dose levels of KZR-616 selected based on data from the Phase 1 dose escalation and administered in combination with Mycophenolate Mofetil and prednisone|Placebo administered with Mycophenolate Mofetil and prednisone","Drug","KZR-616|Placebo","Subcutaneous Injection of KZR-616|Subcutaneous injection of matching placebo",null,"KZR-616 Dose Level 1 + standard therapy|KZR-616 Dose Level 2 + standard therapy|Placebo + standard therapy","\n\nPHASE 1b:\n\n 1.  Male or female patients aged 18 to 75 (inclusive)\n 2.  Body Mass Index (BMI) of 18-40 kg/m2\n 3.  Fulfills the 2012 Systemic Lupus International Collaborating Clinics (SLICC) classification criteria for SLE\n 4.  Have at least one of the following at screening per central lab: 1. Positive antinuclear antibody (ANA) test (1:80 or higher); or\n      2. Anti-double stranded deoxyribonucleic acid (dsDNA) antibodies elevated to above normal (i.e. positive results); or\n      3. Anti-Smith antibody elevated to above normal (i.e., positive results)\n     \n     \n 5.  Active SLE as indicated by a Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) total score â‰¥ 4 at screening\n 6.  Must have received 1 or more therapies for SLE\n 7.  Acceptable screening laboratory values of concern, including: 1. Adequate hematologic criteria:\n      2. Adequate hepatic function:\n      3. Pancreatic enzymes\n      4. eGFR â‰¥ 40 mL/min/1.73 m2 (estimated based on Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula)\n      5. IgG â‰¥ 500 mg/dL\n     \n     \n 8.  If taking the following SLE therapies: 1. Oral glucocorticoids (up to 20 mg/day prednisone or equivalent): must be on a stable dosage regimen of oral corticosteroid at least 4 weeks prior to screening and maintain stable dose until randomization\n      2. Hydroxychloroquine (â‰¤ 400 mg/day) or chloroquine (â‰¤ 500 mg/day) orally or other anti-malarials: must be started or stopped at least 12 weeks prior to screening, with stable dosage regimen for at least 4 weeks prior to screening\n      3. Immunosuppressive agents: must be started or stopped at least 12 weeks prior to screening, with stable dosage regimen, including route of administration, for at least 4 weeks prior to screening: * Mycophenolate mofetil (â‰¤ 3 g/day) or mycophenolic acid (â‰¤ 2.16 g/day) orally\n          * Azathioprine (â‰¤ 200 mg/day) orally\n          * Methotrexate (â‰¤ 25 mg/week) orally, SC, or intramuscularly (patients must be on concomitant folic or folinic acid supplementation if using methotrexate)\n          * Leflunomide (â‰¤ 20 mg/day) orally\n         \n         \n     \n     \n 9.  Women of childbearing potential must have a negative serum beta-human chorionic gonadotropin (hCG) pregnancy test at screening and a negative urine pregnancy test prior to the first dose and must agree to use a highly effective method of birth control from signing the informed consent form (ICF) until their completion of the study (or 30 days following the last dose of study drug in case of early withdrawal). Hormonal contraception may not be effective in women on concomitant MMF/MPA; women on MMF/MPA using hormonal contraception must agree to use a highly effective non-hormonal method of contraception. Abstinence is not an acceptable method of birth control for this study. Women of nonchildbearing potential must be postmenopausal (no menses for at least 2 years before the screening visit), permanently sterilized (e.g., bilateral tubal occlusion, hysterectomy, bilateral salpingectomy), or congenitally sterile\n 10. Male patients must use an effective contraception method (e.g., condom with spermicide) from signing the ICF until their completion of the study (or 12 weeks following the last dose of study drug in case of withdrawal) or be congenitally or surgically sterile (e.g., vasectomy with documented confirmation of post-surgical aspermia)\n 11. Willing and able to provide written informed consent prior to any study-related procedures and to comply with all study requirements\n\nPHASE 2:\n\n 1.  Male or female patients aged 18 to 75 years (inclusive)\n 2.  BMI of 18-40 kg/m2\n 3.  Fulfills the 2012 Systemic Lupus International Collaborating Clinics (SLICC) classification criteria for SLE.\n 4.  Undergoing an ACR-recommended MMF- or MPA-based induction therapy regimen for lupus nephritis for 4 to 12 weeks, and willing to continue at least the MMF/MPA portion of the regimen unaltered throughout the duration of the study. Must be receiving a stable regimen of oral corticosteroids for at least 2 weeks prior to screening\n 5.  The patient has at least one of the following at screening per central lab: 1. Positive ANA test (1:80 or higher) or\n      2. Anti-dsDNA antibodies elevated to above normal (i.e., positive results); or\n      3. Anti-Smith antibody at screening elevated to above normal (i.e., positive results)\n     \n     \n 6.  Kidney biopsy within 26 weeks prior to randomization with a histologic diagnosis of LN (International Society of Nephrology/Renal Pathology Society 2003 classification of lupus nephritis [ISN/RPS]) Classes III, IV-S or IV-G, (A) or (A/C); Patients with Class III or IV and concomitant Class V will be permitted (NOTE: Patients meeting all inclusion criteria with a kidney biopsy of greater than 26 weeks will be allowed following a repeat biopsy which shows the necessary histologic diagnosis prior to study entry)\n 7.  UPCR of â‰¥ 1.0 in 24-hour urine collection\n 8.  Acceptable screening laboratory values of concern, including: 1. Adequate hematologic criteria:\n      2. Adequate hepatic function:\n      3. Pancreatic enzymes\n      4. eGFR â‰¥ 40 mL/min/1.73 m2 estimated based on CKD-EPI formula\n      5. IgG â‰¥ 500 mg/dL\n     \n     \n 9.  Women of childbearing potential must have a negative serum beta-hCG pregnancy test at screening and negative urine pregnancy test prior to the first dose and must agree to use a highly effective method of birth control from signing the ICF until their completion of the study (or 30 days following the last dose of study drug in case of early withdrawal). Hormonal contraception may not be effective in women on concomitant MMF/MPA; women on MMF or MPA using hormonal contraception must agree to use a highly effective non-hormonal method of contraception. Abstinence is not an acceptable method of birth control for this study. Women of nonchildbearing potential must be postmenopausal (no menses for at least 2 years before the screening visit), permanently sterilized (e.g., bilateral tubal occlusion, hysterectomy, bilateral salpingectomy), or congenitally sterile\n 10. Male patients must use an effective contraception method (e.g., condom with spermicide) from signing the ICF until completion of the study (or 12 weeks following the last dose of study drug in case of early withdrawal) or be congenitally or surgically sterile (e.g., vasectomy with documented confirmation of post-surgical aspermia)\n 11. Willing and able to provide written informed consent prior to any study-related procedures and to comply with all study requirements\n\n","\n\nPHASE 1b:\n\n 1. Active central nervous system involvement by autoimmune disease requiring specific therapeutic intervention within 60 days prior to first day of study treatment. Headache treated only with acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs), or approved doses of triptans is permitted with medical monitor approval.\n 2. Presence of another rheumatic (overlap) disease that may confound clinical assessments in the study. Secondary sicca or Sjogren's syndrome, antiphospholipid antibody syndrome, and overlap with rheumatoid arthritis without erosive joint disease (\"rhupus\") are allowed\n 3. History of severe antiphospholipid syndrome within 12 months of screening or not on an adequate anticoagulation regimen. However, presence of antiphospholipid antibodies alone (without a history of thromboembolic event) is not exclusionary.\n 4. Receipt of any of the following treatments within the following timeframes before screening 1.  Systemic corticosteroids â‰¥ 100 mg prednisone or equivalent: 4 weeks\n     2.  Intra-articular therapies, such as corticosteroids or hyaluronic acid preparations: 4 weeks\n     3.  Intravenous Immunoglobulin (IVIg): 4 weeks\n     4.  Other non-biologic immunosuppressive agents, such as cyclosporine, tacrolimus: 4 weeks\n     5.  Cyclophosphamide: 12 weeks\n     6.  Cytokine antagonists: 12 weeks\n     7.  B-cell-depleting therapies (e.g., rituximab): 24 weeks\n     8.  Belimumab, abatacept, or atacicept: 12 weeks\n     9.  Other biologics or investigational drugs: 8 weeks or 5 half-lives, whichever is longer\n     10. Transfusion with blood, packed red blood cells, platelets or treatment with plasmapheresis or plasma exchange: 6 weeks\n    \n    \n 5. Patient has had recent serious or ongoing infection, or risk for serious infection\n 6. History of any concurrent illness that has required treatment with oral or parenteral corticosteroids for more than a total of 2 weeks within the last 24 weeks prior to signing the ICF\n 7. Clinical evidence of significant unstable or uncontrolled acute or chronic diseases that, in the opinion of the investigator or sponsor, could confound the results of the study, put the patient at undue risk, or interfere with protocol adherence\n 8. History of cancer, except for in situ cancer that has been completely excised or has been curatively treated cancer with no sign of disease for > 5 years\n 9. Major surgery within 4 weeks before signing the ICF or major surgery planned during the study period\n\nPHASE 2:\n\n 1.  Active central nervous system involvement by autoimmune disease requiring specific therapeutic intervention within 60 days prior to first day of study treatment. Headache treated only with acetaminophen, NSAIDs, or approved doses of triptans is permitted with medical monitor approval.\n 2.  Isolated Class V membranous LN on a renal biopsy obtained within 26 weeks prior to signing ICF or during the screening period\n 3.  Known intolerance to MMF or MPA\n 4.  History of dialysis within 12 months prior to signing the ICF or expected need for renal replacement therapy (dialysis or renal transplant) within a 6-month period after enrollment\n 5.  History of Rapidly Progressive Glomerulonephritis (RPGN) and/or other renal disease\n 6.  History of chronic kidney disease not directly due to LN\n 7.  Uncontrolled blood pressure (systolic blood pressure â‰¥160 mmHg and diastolic blood pressure â‰¥100 mmHg at rest)o If currently on RAS blockade (ACE-I, ARB, direct renin inhibitors), dose must be stable for at least 4 weeks prior to screening\n     \n     \n 8.  Receipt of any of the following treatments within the following timeframes before first day of study treatment: 1.  IVIg: 4 weeks\n      2.  Corticosteroids â‰¥ 1 g/day prednisone or equivalent: 4 weeks\n      3.  Intra-articular therapies, such as corticosteroids or hyaluronic acid preparations: 4 weeks\n      4.  Conventional disease-modifying antirheumatic drugs, including methotrexate, leflunomide, sulfasalazine, cyclosporine, tacrolimus: 12 weeks\n      5.  MMF of â‰¥ 3 g (or 2.16 g of MPA) for â‰¥ 4 weeks, cyclophosphamide: 24 weeks\n      6.  Cytokine antagonists: 12 weeks\n      7.  B-cell-depleting therapies (e.g., rituximab): 24 weeks\n      8.  Other biologics or investigational drugs: 8 weeks or 5 half-lives, whichever is longer\n      9.  Hydroxychloroquine (>400 mg/day) or chloroquine (>500 mg/day) or other antimalarials above the recommended dose. Antimalarials, if used, must have been started or stopped at least 12 weeks prior to first dose, with stable dosage regimen for at least 4 weeks prior to first dose of study treatment\n      10. Abatacept: 12 weeks\n     \n     \n 9.  Major surgery within 4 weeks before signing the ICF or major surgery planned during the study period\n 10. History of any other concurrent illness, including drug induced SLE, that has required treatment with oral or parenteral corticosteroids for more than a total of 2 weeks within the last 24 weeks prior to signing the ICF\n 11. Patient has had recent serious or ongoing infection, or risk for serious infection\n 12. Clinical evidence of significant unstable or uncontrolled acute or chronic diseases in the opinion of the investigator\n 13. History of cancer, except for in situ cancer that has been completely excised or has been curatively treated with no sign of disease for > 5 years\n 14. Presence of another rheumatic (overlap) disease that nay confound clinical assessment in the study.\n 15. History of antiphospholipid syndrome with history of thromboembolic event within 12 months of screening or not an adequate anticoagulation regimen. However history of antiphospholipid antibodies alone (without history of thromboembolic event) is not exclusionary.","EGFR","epidermal growth factor receptor","Protein","Ovary, Breast, Lung","Actual","2018-01-08","Actual","Anticipated","2020-05-01","Anticipated","2019-03-01","2017-12-21","2018-01-04","2019-03-22","Yes","immunoproteasome inhibition\nselective proteasome inhibition\nproteasome","Interventional","Treatment","Sequential Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years","75 Years","All",null,"No","Undecided",{"$nulls":3},"Yes","No",{"$nulls":19},"Phase 1 and Phase 2: Safety and Tolerability assessed by monitoring incidence and severity of adverse events","Baseline through 25 weeks",null,"Phase 1: Identify Recommended Phase 2 dose levels (RP2Ds) of KZR-616|Phase 1: Peak plasma concentration (Cmax) following injection with KZR-616|Phase 1: Time to peak plasma concentration (Tmax) of KZR-616|Phase 1: Area under the plasma concentration versus time curve (AUC) of KZR-616|Phase 1: Half-life of KZR-616 (T1/2)|Phase 2: The number of patients with a 50% reduction in urine protein to creatinine ratio (UPCR)|Phase 2: The number of patients with a complete renal response|Phase 2: Change from baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K)|Phase 2: Change from baseline in British Isles Lupus Assessment Group (BILAG) score|Phase 2: Change from baseline in Levels of Autoantibodies (ANA and anti-dsDNA) and Complement (C3 and C4)|Phase 2: Change from baseline in UPCR|Phase 2: Change from baseline in eGFR|Phase 2: Change from baseline in daily glucocorticoid use|Other Pre-specified Outcome Measures:|Phase 1 and 2: Inhibition of chymotrypsin-like (CT-L) activity in whole blood and peripheral blood mononuclear cells (PBMCs);|Phase 1 and 2: Assessment of proteasome sub-unit occupancy in whole blood and PBMCs","Determined through assessment of all AEs and any dose limiting toxicities (DLTs)|Day 1|Day 29|Baseline and every 4 weeks through 25 weeks|UPCR of â‰¤ 0.5; estimated Glomerular Filtration Rate (eGFR) of â‰¥ 60 mL/min or no worsening of eGFR from baseline of > 20%; No discontinuation of investigational product or use of restricted medication beyond the protocol-allowed thresholds from Days 1 to 85|Other Pre-specified Outcome Measures:","4 weeks|Every 4 weeks through 25 weeks","dbomba@kezarbio.com","Director of Clinical Operations","650 822-5617","Parkville, Victoria, Australia, 3052|Bucaramanga, Santander, Colombia|Upland, California, United States, 91786|Coral Gables, Florida, United States, 33134 Kzr Research SiteMiami, Florida, United States, 33136 Kzr Research SiteMiami, Florida, United States, 33165 Kzr Research SiteOrlando, Florida, United States, 32810 Kzr Research SitePalm Harbor, Florida, United States, 34684 Kzr Research SiteTampa, Florida, United States, 33613|Great Neck, New York, United States, 11021 Kzr Research SiteManhasset, New York, United States, 11030 Kzr Research SiteRochester, New York, United States, 14642|Columbus, Ohio, United States, 43210|Memphis, Tennessee, United States, 38119|Houston, Texas, United States, 77034 Kzr Research SiteHouston, Texas, United States, 77084","California|Florida|New York|Ohio|Tennessee|Texas","Australia|Colombia|United States","Victoria Kzr Research Site|Santander Kzr Research Site|Kzr Research Site",{"$nulls":3},"Kezar","2019-03-22","2020-05-25T16:35:40.209","2020-05-26T17:10:42.972","NCT03393013"]
["5ecbf3dc307e3d1b1f8d9c6e","NCT03393013","2019-05-20","Kezar Life Sciences","KZR","Recruiting","A Study of KZR-616 in Patients With Systemic Lupus Erythematosus With and Without Nephritis","Kzr-616","Proteasome Inhibitor","Yes","['Kzr-616']","No",null,"Phase 1/Phase 2",3,72,"Anticipated","2018-03-07","2020-02-01",{"$nulls":5},"This is a Phase 1b/2, multi-center study in which patients will receive KZR-616, administered as a subcutaneous (SC) injection weekly for 13 weeks.\n\nThe study consists of 2 parts. Part 1, the Phase 1b, is an open-label multiple dose escalation study to evaluate the safety and tolerability of KZR-616 in patients with systemic lupus erythematosus (SLE) with and without nephritis. Part 2, the Phase 2, is a randomized, placebo-controlled, double-blind study to evaluate the safety and efficacy of KZR-616 in patients with active proliferative lupus nephritis (LN).",null,"A Phase 1b/2 Study of KZR-616 in Patients With Systemic Lupus Erythematosus With and Without Nephritis","KZR-616-002","Systemic Lupus Erythematosus\nLupus Nephritis","Lupus Erythematosus|Lupus Erythematosus, Systemic|Erythema|Lupus Nephritis|Nephritis","Connective Tissue Diseases|Dermatological Diseases|Urologic Diseases","Derm & Connective Tissue Disorders|Reproductive and Urogenital","Experimental|Placebo Comparator","KZR-616 Dose Level 1 + standard therapy|KZR-616 Dose Level 2 + standard therapy|Placebo + standard therapy","1 of 2 dose levels of KZR-616 selected based on data from the Phase 1 dose escalation and administered in combination with Mycophenolate Mofetil (MMF) and prednisone|1 of 2 dose levels of KZR-616 selected based on data from the Phase 1 dose escalation and administered in combination with MMF and prednisone|Placebo administered with MMF and prednisone","Drug","KZR-616|Placebo","Subcutaneous Injection of KZR-616|Subcutaneous injection of matching placebo",null,"KZR-616 Dose Level 1 + standard therapy|KZR-616 Dose Level 2 + standard therapy|Placebo + standard therapy","\n\nPHASE 1b:\n\n 1.  Male or female patients aged 18 to 75 (inclusive)\n 2.  Body Mass Index (BMI) of 18-40 kg/m2\n 3.  Fulfills the 2012 Systemic Lupus International Collaborating Clinics (SLICC) classification criteria for SLE\n 4.  Have at least one of the following at screening per central lab: 1. Positive antinuclear antibody (ANA) test (1:80 or higher); or\n      2. Anti-double stranded deoxyribonucleic acid (dsDNA) antibodies elevated to above normal (i.e. positive results); or\n      3. Anti-Smith antibody elevated to above normal (i.e., positive results)\n     \n     \n 5.  Active SLE as indicated by a Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) total score â‰¥ 4 at screening\n 6.  Must have received 1 or more therapies for SLE\n 7.  Acceptable screening laboratory values of concern, including: 1. Adequate hematologic criteria:\n      2. Adequate hepatic function:\n      3. Pancreatic enzymes\n      4. eGFR â‰¥ 40 mL/min/1.73 m2 (estimated based on Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula)\n      5. IgG â‰¥ 500 mg/dL\n     \n     \n 8.  If taking the following SLE therapies: 1. Oral glucocorticoids (up to 20 mg/day prednisone or equivalent): must be on a stable dosage regimen of oral corticosteroid at least 4 weeks prior to screening and maintain stable dose until randomization\n      2. Hydroxychloroquine (â‰¤ 400 mg/day) or chloroquine (â‰¤ 500 mg/day) orally or other anti-malarials: must be started or stopped at least 12 weeks prior to screening, with stable dosage regimen for at least 4 weeks prior to screening\n      3. Immunosuppressive agents: must be started or stopped at least 12 weeks prior to screening, with stable dosage regimen, including route of administration, for at least 4 weeks prior to screening: * Mycophenolate mofetil (â‰¤ 3 g/day) or mycophenolic acid (â‰¤ 2.16 g/day) orally\n          * Azathioprine (â‰¤ 200 mg/day) orally\n          * Methotrexate (â‰¤ 25 mg/week) orally, SC, or intramuscularly (patients must be on concomitant folic or folinic acid supplementation if using methotrexate)\n          * Leflunomide (â‰¤ 20 mg/day) orally\n         \n         \n     \n     \n 9.  Women of childbearing potential must have a negative serum beta-human chorionic gonadotropin (hCG) pregnancy test at screening and a negative urine pregnancy test prior to the first dose and must agree to use a highly effective method of birth control from signing the informed consent form (ICF) until their completion of the study (or 30 days following the last dose of study drug in case of early withdrawal). Hormonal contraception may not be effective in women on concomitant MMF/MPA; women on MMF/MPA using hormonal contraception must agree to use a highly effective non-hormonal method of contraception. Abstinence is not an acceptable method of birth control for this study. Women of nonchildbearing potential must be postmenopausal (no menses for at least 2 years before the screening visit), permanently sterilized (e.g., bilateral tubal occlusion, hysterectomy, bilateral salpingectomy), or congenitally sterile\n 10. Male patients must use an effective contraception method (e.g., condom with spermicide) from signing the ICF until their completion of the study (or 12 weeks following the last dose of study drug in case of withdrawal) or be congenitally or surgically sterile (e.g., vasectomy with documented confirmation of post-surgical aspermia)\n 11. Willing and able to provide written informed consent prior to any study-related procedures and to comply with all study requirements\n\nPHASE 2:\n\n 1.  Male or female patients aged 18 to 75 years (inclusive)\n 2.  BMI of 18-40 kg/m2\n 3.  Fulfills the 2012 Systemic Lupus International Collaborating Clinics (SLICC) classification criteria for SLE.\n 4.  Undergoing an ACR-recommended MMF- or MPA-based induction therapy regimen for lupus nephritis for 4 to 12 weeks, and willing to continue at least the MMF/MPA portion of the regimen unaltered throughout the duration of the study. Must be receiving a stable regimen of oral corticosteroids for at least 2 weeks prior to screening\n 5.  The patient has at least one of the following at screening per central lab: 1. Positive ANA test (1:80 or higher) or\n      2. Anti-dsDNA antibodies elevated to above normal (i.e., positive results); or\n      3. Anti-Smith antibody at screening elevated to above normal (i.e., positive results)\n     \n     \n 6.  Kidney biopsy within 26 weeks prior to randomization with a histologic diagnosis of LN (International Society of Nephrology/Renal Pathology Society 2003 classification of lupus nephritis [ISN/RPS]) Classes III, IV-S or IV-G, (A) or (A/C); Patients with Class III or IV and concomitant Class V will be permitted (NOTE: Patients meeting all inclusion criteria with a kidney biopsy of greater than 26 weeks will be allowed following a repeat biopsy which shows the necessary histologic diagnosis prior to study entry)\n 7.  UPCR of â‰¥ 1.0 in 24-hour urine collection\n 8.  Acceptable screening laboratory values of concern, including: 1. Adequate hematologic criteria:\n      2. Adequate hepatic function:\n      3. Pancreatic enzymes\n      4. eGFR â‰¥ 40 mL/min/1.73 m2 estimated based on CKD-EPI formula\n      5. IgG â‰¥ 500 mg/dL\n     \n     \n 9.  Women of childbearing potential must have a negative serum beta-hCG pregnancy test at screening and negative urine pregnancy test prior to the first dose and must agree to use a highly effective method of birth control from signing the ICF until their completion of the study (or 30 days following the last dose of study drug in case of early withdrawal). Hormonal contraception may not be effective in women on concomitant MMF/MPA; women on MMF or MPA using hormonal contraception must agree to use a highly effective non-hormonal method of contraception. Abstinence is not an acceptable method of birth control for this study. Women of nonchildbearing potential must be postmenopausal (no menses for at least 2 years before the screening visit), permanently sterilized (e.g., bilateral tubal occlusion, hysterectomy, bilateral salpingectomy), or congenitally sterile\n 10. Male patients must use an effective contraception method (e.g., condom with spermicide) from signing the ICF until completion of the study (or 12 weeks following the last dose of study drug in case of early withdrawal) or be congenitally or surgically sterile (e.g., vasectomy with documented confirmation of post-surgical aspermia)\n 11. Willing and able to provide written informed consent prior to any study-related procedures and to comply with all study requirements\n\n","\n\nPHASE 1b:\n\n 1. Active central nervous system involvement by autoimmune disease requiring specific therapeutic intervention within 60 days prior to first day of study treatment. Headache treated only with acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs), or approved doses of triptans is permitted with medical monitor approval.\n 2. Presence of another rheumatic (overlap) disease that may confound clinical assessments in the study. Secondary sicca or Sjogren's syndrome, antiphospholipid antibody syndrome, and overlap with rheumatoid arthritis without erosive joint disease (\"rhupus\") are allowed\n 3. History of severe antiphospholipid syndrome within 12 months of screening or not on an adequate anticoagulation regimen. However, presence of antiphospholipid antibodies alone (without a history of thromboembolic event) is not exclusionary.\n 4. Receipt of any of the following treatments within the following timeframes before screening 1.  Systemic corticosteroids â‰¥ 100 mg prednisone or equivalent: 4 weeks\n     2.  Intra-articular therapies, such as corticosteroids or hyaluronic acid preparations: 4 weeks\n     3.  Intravenous Immunoglobulin (IVIg): 4 weeks\n     4.  Other non-biologic immunosuppressive agents, such as cyclosporine, tacrolimus: 4 weeks\n     5.  Cyclophosphamide: 12 weeks\n     6.  Cytokine antagonists: 12 weeks\n     7.  B-cell-depleting therapies (e.g., rituximab): 24 weeks\n     8.  Belimumab, abatacept, or atacicept: 12 weeks\n     9.  Other biologics or investigational drugs: 8 weeks or 5 half-lives, whichever is longer\n     10. Transfusion with blood, packed red blood cells, platelets or treatment with plasmapheresis or plasma exchange: 6 weeks\n    \n    \n 5. Patient has had recent serious or ongoing infection, or risk for serious infection\n 6. History of any concurrent illness that has required treatment with oral or parenteral corticosteroids for more than a total of 2 weeks within the last 24 weeks prior to signing the ICF\n 7. Clinical evidence of significant unstable or uncontrolled acute or chronic diseases that, in the opinion of the investigator or sponsor, could confound the results of the study, put the patient at undue risk, or interfere with protocol adherence\n 8. History of cancer, except for in situ cancer that has been completely excised or has been curatively treated cancer with no sign of disease for > 5 years\n 9. Major surgery within 4 weeks before signing the ICF or major surgery planned during the study period\n\nPHASE 2:\n\n 1.  Active central nervous system involvement by autoimmune disease requiring specific therapeutic intervention within 60 days prior to first day of study treatment. Headache treated only with acetaminophen, NSAIDs, or approved doses of triptans is permitted with medical monitor approval.\n 2.  Isolated Class V membranous LN on a renal biopsy obtained within 26 weeks prior to signing ICF or during the screening period\n 3.  Known intolerance to MMF or MPA\n 4.  History of dialysis within 12 months prior to signing the ICF or expected need for renal replacement therapy (dialysis or renal transplant) within a 6-month period after enrollment\n 5.  History of Rapidly Progressive Glomerulonephritis (RPGN) and/or other renal disease\n 6.  History of chronic kidney disease not directly due to LN\n 7.  Uncontrolled blood pressure (systolic blood pressure â‰¥160 mmHg and diastolic blood pressure â‰¥100 mmHg at rest)o If currently on RAS blockade (ACE-I, ARB, direct renin inhibitors), dose must be stable for at least 4 weeks prior to screening\n     \n     \n 8.  Receipt of any of the following treatments within the following timeframes before first day of study treatment: 1.  IVIg: 4 weeks\n      2.  Corticosteroids â‰¥ 1 g/day prednisone or equivalent: 4 weeks\n      3.  Intra-articular therapies, such as corticosteroids or hyaluronic acid preparations: 4 weeks\n      4.  Conventional disease-modifying antirheumatic drugs, including methotrexate, leflunomide, sulfasalazine, cyclosporine, tacrolimus: 12 weeks\n      5.  MMF of â‰¥ 3 g (or 2.16 g of MPA) for â‰¥ 4 weeks, cyclophosphamide: 24 weeks\n      6.  Cytokine antagonists: 12 weeks\n      7.  B-cell-depleting therapies (e.g., rituximab): 24 weeks\n      8.  Other biologics or investigational drugs: 8 weeks or 5 half-lives, whichever is longer\n      9.  Hydroxychloroquine (>400 mg/day) or chloroquine (>500 mg/day) or other antimalarials above the recommended dose. Antimalarials, if used, must have been started or stopped at least 12 weeks prior to first dose, with stable dosage regimen for at least 4 weeks prior to first dose of study treatment\n      10. Abatacept: 12 weeks\n     \n     \n 9.  Major surgery within 4 weeks before signing the ICF or major surgery planned during the study period\n 10. History of any other concurrent illness, including drug induced SLE, that has required treatment with oral or parenteral corticosteroids for more than a total of 2 weeks within the last 24 weeks prior to signing the ICF\n 11. Patient has had recent serious or ongoing infection, or risk for serious infection\n 12. Clinical evidence of significant unstable or uncontrolled acute or chronic diseases in the opinion of the investigator\n 13. History of cancer, except for in situ cancer that has been completely excised or has been curatively treated with no sign of disease for > 5 years\n 14. Presence of another rheumatic (overlap) disease that nay confound clinical assessment in the study.\n 15. History of antiphospholipid syndrome with history of thromboembolic event within 12 months of screening or not an adequate anticoagulation regimen. However history of antiphospholipid antibodies alone (without history of thromboembolic event) is not exclusionary.","EGFR","epidermal growth factor receptor","Protein","Ovary, Breast, Lung","Actual","2018-01-08","Actual","Anticipated","2020-05-01","Anticipated","2019-04-01","2017-12-21","2018-01-04","2019-05-16","Yes","immunoproteasome inhibition\nselective proteasome inhibition\nproteasome","Interventional","Treatment","Sequential Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years","75 Years","All",null,"No","Undecided",{"$nulls":3},"Yes","No",{"$nulls":19},"Phase 1 and Phase 2: Safety and Tolerability assessed by monitoring incidence and severity of adverse events (AEs)","Baseline through 25 weeks",null,"Phase 1: Identify Recommended Phase 2 dose levels (RP2Ds) of KZR-616|Phase 1: Peak plasma concentration (Cmax) following injection with KZR-616|Phase 1: Time to peak plasma concentration (Tmax) of KZR-616|Phase 1: Area under the plasma concentration versus time curve (AUC) of KZR-616|Phase 1: Half-life of KZR-616 (T1/2)|Phase 2: The number of patients with a 50% reduction in urine protein to creatinine ratio (UPCR)|Phase 2: The number of patients with a complete renal response|Phase 2: Change from baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K)|Phase 2: Change from baseline in British Isles Lupus Assessment Group (BILAG) score|Phase 2: Change from baseline in Levels of Autoantibodies (ANA and anti-dsDNA) and Complement (C3 and C4)|Phase 2: Change from baseline in UPCR|Phase 2: Change from baseline in eGFR|Phase 2: Change from baseline in daily glucocorticoid use|Other Pre-specified Outcome Measures:|Phase 1 and 2: Inhibition of chymotrypsin-like (CT-L) activity in whole blood and peripheral blood mononuclear cells (PBMCs);|Phase 1 and 2: Assessment of proteasome sub-unit occupancy in whole blood and PBMCs","Determined through assessment of all AEs and any dose limiting toxicities (DLTs)|Day 1|Day 29|Baseline and every 4 weeks through 25 weeks|UPCR of â‰¤ 0.5; estimated Glomerular Filtration Rate (eGFR) of â‰¥ 60 mL/min or no worsening of eGFR from baseline of > 20%; No discontinuation of investigational product or use of restricted medication beyond the protocol-allowed thresholds from Days 1 to 85|Other Pre-specified Outcome Measures:","4 weeks|Every 4 weeks through 25 weeks","clinicaltrials@kezarbio.com","Clinical Operations","650 822-5600","Parkville, Victoria, Australia, 3052|Barranquilla, Atlantico, Colombia|Bucaramanga, Santander, Colombia|Cali, Valle Del Cauca, Colombia|Guadalajara, Jalisco, Mexico|Monterrey, Nuevo Leon, Mexico|Upland, California, United States, 91786|Coral Gables, Florida, United States, 33134 Kzr Research SiteMiami, Florida, United States, 33136 Kzr Research SiteMiami, Florida, United States, 33165 Kzr Research SiteOrlando, Florida, United States, 32810 Kzr Research SitePalm Harbor, Florida, United States, 34684 Kzr Research SiteTampa, Florida, United States, 33613|Great Neck, New York, United States, 11021 Kzr Research SiteManhasset, New York, United States, 11030 Kzr Research SiteRochester, New York, United States, 14642|Columbus, Ohio, United States, 43210|Memphis, Tennessee, United States, 38119|Houston, Texas, United States, 77034 Kzr Research SiteHouston, Texas, United States, 77084","California|Florida|New York|Ohio|Tennessee|Texas","Australia|Colombia|Mexico|United States","Victoria Kzr Research Site|Atlantico Kzr Research Site|Santander Kzr Research Site|Valle Del Cauca Kzr Research Site|Jalisco Kzr Research Site|Nuevo Leon Kzr Research Site|Kzr Research Site",{"$nulls":3},"Kezar","2019-05-16","2020-05-25T16:35:40.135","2020-05-26T17:10:42.972","NCT03393013"]
["5ecbf3dcfeab101b1553080d","NCT03393013","2019-07-26","Kezar Life Sciences","KZR","Recruiting","A Study of KZR-616 in Patients With Systemic Lupus Erythematosus With and Without Nephritis","Kzr-616","Proteasome Inhibitor","Yes","['Kzr-616']","No",null,"Phase 1/Phase 2",3,72,"Anticipated","2018-03-07","2020-02-01",{"$nulls":5},"This is a Phase 1b/2, multi-center study in which patients will receive KZR-616, administered as a subcutaneous (SC) injection weekly for 13 weeks.\n\nThe study consists of 2 parts. Part 1, the Phase 1b, is an open-label multiple dose escalation study to evaluate the safety and tolerability of KZR-616 in patients with systemic lupus erythematosus (SLE) with and without nephritis. Part 2, the Phase 2, is a randomized, placebo-controlled, double-blind study to evaluate the safety and efficacy of KZR-616 in patients with active proliferative lupus nephritis (LN).",null,"A Phase 1b/2 Study of KZR-616 in Patients With Systemic Lupus Erythematosus With and Without Nephritis","KZR-616-002","Systemic Lupus Erythematosus\nLupus Nephritis","Lupus Erythematosus|Lupus Erythematosus, Systemic|Erythema|Lupus Nephritis|Nephritis","Connective Tissue Diseases|Dermatological Diseases|Urologic Diseases","Derm & Connective Tissue Disorders|Reproductive and Urogenital","Experimental|Placebo Comparator","KZR-616 Dose Level 1 + standard therapy|KZR-616 Dose Level 2 + standard therapy|Placebo + standard therapy","1 of 2 dose levels of KZR-616 selected based on data from the Phase 1 dose escalation and administered in combination with Mycophenolate Mofetil (MMF) and prednisone|1 of 2 dose levels of KZR-616 selected based on data from the Phase 1 dose escalation and administered in combination with MMF and prednisone|Placebo administered with MMF and prednisone","Drug","KZR-616|Placebo","Subcutaneous Injection of KZR-616|Subcutaneous injection of matching placebo",null,"KZR-616 Dose Level 1 + standard therapy|KZR-616 Dose Level 2 + standard therapy|Placebo + standard therapy","\n\nPHASE 1b:\n\n 1.  Male or female patients aged 18 to 75 (inclusive)\n 2.  Body Mass Index (BMI) of 18-40 kg/m2\n 3.  Fulfills the 2012 Systemic Lupus International Collaborating Clinics (SLICC) classification criteria for SLE\n 4.  Have at least one of the following at screening per central lab: 1. Positive antinuclear antibody (ANA) test (1:80 or higher); or\n      2. Anti-double stranded deoxyribonucleic acid (dsDNA) antibodies elevated to above normal (i.e. positive results); or\n      3. Anti-Smith antibody elevated to above normal (i.e., positive results)\n     \n     \n 5.  Active SLE as indicated by a Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) total score â‰¥ 4 at screening\n 6.  Must have received 1 or more therapies for SLE\n 7.  Acceptable screening laboratory values of concern, including: 1. Adequate hematologic criteria:\n      2. Adequate hepatic function:\n      3. Pancreatic enzymes\n      4. eGFR â‰¥ 40 mL/min/1.73 m2 (estimated based on Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula)\n      5. IgG â‰¥ 500 mg/dL\n     \n     \n 8.  If taking the following SLE therapies: 1. Oral glucocorticoids (up to 20 mg/day prednisone or equivalent): must be on a stable dosage regimen of oral corticosteroid at least 4 weeks prior to screening and maintain stable dose until randomization\n      2. Hydroxychloroquine (â‰¤ 400 mg/day) or chloroquine (â‰¤ 500 mg/day) orally or other anti-malarials: must be started or stopped at least 12 weeks prior to screening, with stable dosage regimen for at least 4 weeks prior to screening\n      3. Immunosuppressive agents: must be started or stopped at least 12 weeks prior to screening, with stable dosage regimen, including route of administration, for at least 4 weeks prior to screening: * Mycophenolate mofetil (â‰¤ 3 g/day) or mycophenolic acid (â‰¤ 2.16 g/day) orally\n          * Azathioprine (â‰¤ 200 mg/day) orally\n          * Methotrexate (â‰¤ 25 mg/week) orally, SC, or intramuscularly (patients must be on concomitant folic or folinic acid supplementation if using methotrexate)\n          * Leflunomide (â‰¤ 20 mg/day) orally\n         \n         \n     \n     \n 9.  Women of childbearing potential must have a negative serum beta-human chorionic gonadotropin (hCG) pregnancy test at screening and a negative urine pregnancy test prior to the first dose and must agree to use a highly effective method of birth control from signing the informed consent form (ICF) until their completion of the study (or 30 days following the last dose of study drug in case of early withdrawal). Hormonal contraception may not be effective in women on concomitant MMF/MPA; women on MMF/MPA using hormonal contraception must agree to use a highly effective non-hormonal method of contraception. Abstinence is not an acceptable method of birth control for this study. Women of nonchildbearing potential must be postmenopausal (no menses for at least 2 years before the screening visit), permanently sterilized (e.g., bilateral tubal occlusion, hysterectomy, bilateral salpingectomy), or congenitally sterile\n 10. Male patients must use an effective contraception method (e.g., condom with spermicide) from signing the ICF until their completion of the study (or 12 weeks following the last dose of study drug in case of withdrawal) or be congenitally or surgically sterile (e.g., vasectomy with documented confirmation of post-surgical aspermia)\n 11. Willing and able to provide written informed consent prior to any study-related procedures and to comply with all study requirements\n\nPHASE 2:\n\n 1.  Male or female patients aged 18 to 75 years (inclusive)\n 2.  BMI of 18-40 kg/m2\n 3.  Fulfills the 2012 Systemic Lupus International Collaborating Clinics (SLICC) classification criteria for SLE.\n 4.  Undergoing an ACR-recommended MMF- or MPA-based induction therapy regimen for lupus nephritis for 4 to 12 weeks, and willing to continue at least the MMF/MPA portion of the regimen unaltered throughout the duration of the study. Must be receiving a stable regimen of oral corticosteroids for at least 2 weeks prior to screening\n 5.  The patient has at least one of the following at screening per central lab: 1. Positive ANA test (1:80 or higher) or\n      2. Anti-dsDNA antibodies elevated to above normal (i.e., positive results); or\n      3. Anti-Smith antibody at screening elevated to above normal (i.e., positive results)\n     \n     \n 6.  Kidney biopsy within 26 weeks prior to randomization with a histologic diagnosis of LN (International Society of Nephrology/Renal Pathology Society 2003 classification of lupus nephritis [ISN/RPS]) Classes III, IV-S or IV-G, (A) or (A/C); Patients with Class III or IV and concomitant Class V will be permitted (NOTE: Patients meeting all inclusion criteria with a kidney biopsy of greater than 26 weeks will be allowed following a repeat biopsy which shows the necessary histologic diagnosis prior to study entry)\n 7.  UPCR of â‰¥ 1.0 in 24-hour urine collection\n 8.  Acceptable screening laboratory values of concern, including: 1. Adequate hematologic criteria:\n      2. Adequate hepatic function:\n      3. Pancreatic enzymes\n      4. eGFR â‰¥ 40 mL/min/1.73 m2 estimated based on CKD-EPI formula\n      5. IgG â‰¥ 500 mg/dL\n     \n     \n 9.  Women of childbearing potential must have a negative serum beta-hCG pregnancy test at screening and negative urine pregnancy test prior to the first dose and must agree to use a highly effective method of birth control from signing the ICF until their completion of the study (or 30 days following the last dose of study drug in case of early withdrawal). Hormonal contraception may not be effective in women on concomitant MMF/MPA; women on MMF or MPA using hormonal contraception must agree to use a highly effective non-hormonal method of contraception. Abstinence is not an acceptable method of birth control for this study. Women of nonchildbearing potential must be postmenopausal (no menses for at least 2 years before the screening visit), permanently sterilized (e.g., bilateral tubal occlusion, hysterectomy, bilateral salpingectomy), or congenitally sterile\n 10. Male patients must use an effective contraception method (e.g., condom with spermicide) from signing the ICF until completion of the study (or 12 weeks following the last dose of study drug in case of early withdrawal) or be congenitally or surgically sterile (e.g., vasectomy with documented confirmation of post-surgical aspermia)\n 11. Willing and able to provide written informed consent prior to any study-related procedures and to comply with all study requirements\n\n","\n\nPHASE 1b:\n\n 1. Active central nervous system involvement by autoimmune disease requiring specific therapeutic intervention within 60 days prior to first day of study treatment. Headache treated only with acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs), or approved doses of triptans is permitted with medical monitor approval.\n 2. Presence of another rheumatic (overlap) disease that may confound clinical assessments in the study. Secondary sicca or Sjogren's syndrome, antiphospholipid antibody syndrome, and overlap with rheumatoid arthritis without erosive joint disease (\"rhupus\") are allowed\n 3. History of severe antiphospholipid syndrome within 12 months of screening or not on an adequate anticoagulation regimen. However, presence of antiphospholipid antibodies alone (without a history of thromboembolic event) is not exclusionary.\n 4. Receipt of any of the following treatments within the following timeframes before screening 1.  Systemic corticosteroids â‰¥ 100 mg prednisone or equivalent: 4 weeks\n     2.  Intra-articular therapies, such as corticosteroids or hyaluronic acid preparations: 4 weeks\n     3.  Intravenous Immunoglobulin (IVIg): 4 weeks\n     4.  Other non-biologic immunosuppressive agents, such as cyclosporine, tacrolimus: 4 weeks\n     5.  Cyclophosphamide: 12 weeks\n     6.  Cytokine antagonists: 12 weeks\n     7.  B-cell-depleting therapies (e.g., rituximab): 24 weeks\n     8.  Belimumab, abatacept, or atacicept: 12 weeks\n     9.  Other biologics or investigational drugs: 8 weeks or 5 half-lives, whichever is longer\n     10. Transfusion with blood, packed red blood cells, platelets or treatment with plasmapheresis or plasma exchange: 6 weeks\n    \n    \n 5. Patient has had recent serious or ongoing infection, or risk for serious infection\n 6. History of any concurrent illness that has required treatment with oral or parenteral corticosteroids for more than a total of 2 weeks within the last 24 weeks prior to signing the ICF\n 7. Clinical evidence of significant unstable or uncontrolled acute or chronic diseases that, in the opinion of the investigator or sponsor, could confound the results of the study, put the patient at undue risk, or interfere with protocol adherence\n 8. History of cancer, except for in situ cancer that has been completely excised or has been curatively treated cancer with no sign of disease for > 5 years\n 9. Major surgery within 4 weeks before signing the ICF or major surgery planned during the study period\n\nPHASE 2:\n\n 1.  Active central nervous system involvement by autoimmune disease requiring specific therapeutic intervention within 60 days prior to first day of study treatment. Headache treated only with acetaminophen, NSAIDs, or approved doses of triptans is permitted with medical monitor approval.\n 2.  Isolated Class V membranous LN on a renal biopsy obtained within 26 weeks prior to signing ICF or during the screening period\n 3.  Known intolerance to MMF or MPA\n 4.  History of dialysis within 12 months prior to signing the ICF or expected need for renal replacement therapy (dialysis or renal transplant) within a 6-month period after enrollment\n 5.  History of Rapidly Progressive Glomerulonephritis (RPGN) and/or other renal disease\n 6.  History of chronic kidney disease not directly due to LN\n 7.  Uncontrolled blood pressure (systolic blood pressure â‰¥160 mmHg and diastolic blood pressure â‰¥100 mmHg at rest)o If currently on RAS blockade (ACE-I, ARB, direct renin inhibitors), dose must be stable for at least 4 weeks prior to screening\n     \n     \n 8.  Receipt of any of the following treatments within the following timeframes before first day of study treatment: 1.  IVIg: 4 weeks\n      2.  Corticosteroids â‰¥ 1 g/day prednisone or equivalent: 4 weeks\n      3.  Intra-articular therapies, such as corticosteroids or hyaluronic acid preparations: 4 weeks\n      4.  Conventional disease-modifying antirheumatic drugs, including methotrexate, leflunomide, sulfasalazine, cyclosporine, tacrolimus: 12 weeks\n      5.  MMF of â‰¥ 3 g (or 2.16 g of MPA) for â‰¥ 4 weeks, cyclophosphamide: 24 weeks\n      6.  Cytokine antagonists: 12 weeks\n      7.  B-cell-depleting therapies (e.g., rituximab): 24 weeks\n      8.  Other biologics or investigational drugs: 8 weeks or 5 half-lives, whichever is longer\n      9.  Hydroxychloroquine (>400 mg/day) or chloroquine (>500 mg/day) or other antimalarials above the recommended dose. Antimalarials, if used, must have been started or stopped at least 12 weeks prior to first dose, with stable dosage regimen for at least 4 weeks prior to first dose of study treatment\n      10. Abatacept: 12 weeks\n     \n     \n 9.  Major surgery within 4 weeks before signing the ICF or major surgery planned during the study period\n 10. History of any other concurrent illness, including drug induced SLE, that has required treatment with oral or parenteral corticosteroids for more than a total of 2 weeks within the last 24 weeks prior to signing the ICF\n 11. Patient has had recent serious or ongoing infection, or risk for serious infection\n 12. Clinical evidence of significant unstable or uncontrolled acute or chronic diseases in the opinion of the investigator\n 13. History of cancer, except for in situ cancer that has been completely excised or has been curatively treated with no sign of disease for > 5 years\n 14. Presence of another rheumatic (overlap) disease that nay confound clinical assessment in the study.\n 15. History of antiphospholipid syndrome with history of thromboembolic event within 12 months of screening or not an adequate anticoagulation regimen. However history of antiphospholipid antibodies alone (without history of thromboembolic event) is not exclusionary.","EGFR","epidermal growth factor receptor","Protein","Ovary, Breast, Lung","Actual","2018-01-08","Actual","Anticipated","2020-05-01","Anticipated","2019-04-01","2017-12-21","2018-01-04","2019-07-24",null,"immunoproteasome inhibition\nselective proteasome inhibition\nproteasome","Interventional","Treatment","Sequential Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years","75 Years","All",null,"No","Undecided",{"$nulls":3},"Yes","No",{"$nulls":19},"Phase 1 and Phase 2: Safety and Tolerability assessed by monitoring incidence and severity of adverse events (AEs)","Baseline through 25 weeks",null,"Phase 1: Identify Recommended Phase 2 dose levels (RP2Ds) of KZR-616|Phase 1: Peak plasma concentration (Cmax) following injection with KZR-616|Phase 1: Time to peak plasma concentration (Tmax) of KZR-616|Phase 1: Area under the plasma concentration versus time curve (AUC) of KZR-616|Phase 1: Half-life of KZR-616 (T1/2)|Phase 2: The number of patients with a 50% reduction in urine protein to creatinine ratio (UPCR)|Phase 2: The number of patients with a complete renal response|Phase 2: Change from baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K)|Phase 2: Change from baseline in British Isles Lupus Assessment Group (BILAG) score|Phase 2: Change from baseline in Levels of Autoantibodies (ANA and anti-dsDNA) and Complement (C3 and C4)|Phase 2: Change from baseline in UPCR|Phase 2: Change from baseline in eGFR|Phase 2: Change from baseline in daily glucocorticoid use|Other Pre-specified Outcome Measures:|Phase 1 and 2: Inhibition of chymotrypsin-like (CT-L) activity in whole blood and peripheral blood mononuclear cells (PBMCs);|Phase 1 and 2: Assessment of proteasome sub-unit occupancy in whole blood and PBMCs","Determined through assessment of all AEs and any dose limiting toxicities (DLTs)|Day 1|Day 29|Baseline and every 4 weeks through 25 weeks|UPCR of â‰¤ 0.5; estimated Glomerular Filtration Rate (eGFR) of â‰¥ 60 mL/min or no worsening of eGFR from baseline of > 20%; No discontinuation of investigational product or use of restricted medication beyond the protocol-allowed thresholds from Days 1 to 85|Other Pre-specified Outcome Measures:","4 weeks|Every 4 weeks through 25 weeks","clinicaltrials@kezarbio.com","Clinical Operations","650 822-5600","Parkville, Victoria, Australia, 3052|Barranquilla, Atlantico, Colombia|Bucaramanga, Santander, Colombia|Cali, Valle Del Cauca, Colombia|Guadalajara, Jalisco, Mexico|Monterrey, Nuevo Leon, Mexico|Upland, California, United States, 91786|Coral Gables, Florida, United States, 33134 Kzr Research SiteMiami, Florida, United States, 33136 Kzr Research SiteMiami, Florida, United States, 33165 Kzr Research SiteOrlando, Florida, United States, 32810 Kzr Research SitePalm Harbor, Florida, United States, 34684 Kzr Research SiteTampa, Florida, United States, 33613|Great Neck, New York, United States, 11021 Kzr Research SiteManhasset, New York, United States, 11030 Kzr Research SiteRochester, New York, United States, 14642|Columbus, Ohio, United States, 43210|Memphis, Tennessee, United States, 38119|Houston, Texas, United States, 77034 Kzr Research SiteHouston, Texas, United States, 77084","California|Florida|New York|Ohio|Tennessee|Texas","Australia|Colombia|Mexico|United States","Victoria Kzr Research Site|Atlantico Kzr Research Site|Santander Kzr Research Site|Valle Del Cauca Kzr Research Site|Jalisco Kzr Research Site|Nuevo Leon Kzr Research Site|Kzr Research Site",{"$nulls":3},"Kezar","2019-07-24","2020-05-25T16:35:40.087","2020-05-26T17:10:42.972","NCT03393013"]
["5ecbf3dc11702c1b1b9169f1","NCT03393013","2020-01-21","Kezar Life Sciences","KZR","Recruiting","A Study of KZR-616 in Patients With Systemic Lupus Erythematosus With and Without Nephritis (MISSION)","Kzr-616","Proteasome Inhibitor","Yes","['Kzr-616']","No",null,"Phase 1/Phase 2",4,124,"Anticipated","2018-03-07","2021-06-01",{"$nulls":5},"This is a Phase 1b/2, multi-center study in which patients will receive KZR-616, administered as a subcutaneous (SC) injection weekly for 13 weeks (Phase 1b) or 24 weeks (Phase 2).\n\nThe study consists of 2 parts. Part 1, the Phase 1b, is an open-label multiple dose escalation study to evaluate the safety and tolerability of KZR-616 in patients with systemic lupus erythematosus (SLE) with and without nephritis. Part 2, the Phase 2, is a randomized, placebo-controlled, double-blind study to evaluate the safety and efficacy of KZR-616 in patients with active proliferative lupus nephritis (LN).",null,"A Phase 1b/2 Study of KZR-616 in Patients With Systemic Lupus Erythematosus With and Without Nephritis","KZR-616-002","Systemic Lupus Erythematosus\nLupus Nephritis","Lupus Erythematosus|Lupus Erythematosus, Systemic|Erythema|Lupus Nephritis|Nephritis","Connective Tissue Diseases|Dermatological Diseases|Urologic Diseases","Derm & Connective Tissue Disorders|Reproductive and Urogenital","Experimental|Placebo Comparator","KZR-616 30 mg + standard therapy|KZR-616 45 mg + standard therapy|KZR-616 60 mg + standard therapy|Placebo + standard therapy","1 of 3 dose levels of KZR-616 selected based on data from the Phase 1 dose escalation and administered in combination with standard therapy|Placebo administered in combination with standard therapy","Drug","KZR-616|Placebo","Subcutaneous Injection of KZR-616|Subcutaneous injection of matching placebo",null,"KZR-616 30 mg + standard therapy|KZR-616 45 mg + standard therapy|KZR-616 60 mg + standard therapy|Placebo + standard therapy","\n\nPHASE 1b:\n\n 1.  Male or female patients aged 18 to 75 (inclusive)\n 2.  Body Mass Index (BMI) of 18-40 kg/m2\n 3.  Fulfills the 2012 Systemic Lupus International Collaborating Clinics (SLICC) classification criteria for SLE\n 4.  Have at least one of the following at screening per central lab: 1. Positive antinuclear antibody (ANA) test (1:80 or higher); or\n      2. Anti-double stranded deoxyribonucleic acid (dsDNA) antibodies elevated to above normal (i.e. positive results); or\n      3. Anti-Smith antibody elevated to above normal (i.e., positive results)\n     \n     \n 5.  Active SLE as indicated by a Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) total score â‰¥ 4 at screening\n 6.  Must have received 1 or more therapies for SLE\n 7.  Acceptable screening laboratory values of concern, including: 1. Adequate hematologic criteria:\n      2. Adequate hepatic function:\n      3. eGFR â‰¥ 40 mL/min/1.73 m2\n      4. IgG â‰¥ 500 mg/dL\n     \n     \n 8.  If taking the following SLE therapies: 1. Oral glucocorticoids (up to 20 mg/day prednisone or equivalent): must be on a stable dosage regimen of oral corticosteroid at least 4 weeks prior to screening and maintain stable dose until randomization\n      2. Hydroxychloroquine (â‰¤ 400 mg/day) or chloroquine (â‰¤ 500 mg/day) orally or other anti-malarials: must be started or stopped at least 12 weeks prior to screening, with stable dosage regimen for at least 4 weeks prior to screening\n      3. Immunosuppressive agents: must be started or stopped at least 12 weeks prior to screening, with stable dosage regimen, including route of administration, for at least 4 weeks prior to screening: * Mycophenolate mofetil (â‰¤ 3 g/day) or mycophenolic acid (â‰¤ 2.16 g/day) orally\n          * Azathioprine (â‰¤ 200 mg/day) orally\n          * Methotrexate (â‰¤ 25 mg/week) orally, SC, or intramuscularly (patients must be on concomitant folic or folinic acid supplementation if using methotrexate)\n          * Leflunomide (â‰¤ 20 mg/day) orally\n         \n         \n     \n     \n 9.  Women of childbearing potential must have a negative serum beta-human chorionic gonadotropin (hCG) pregnancy test at screening and a negative urine pregnancy test prior to the first dose and must agree to use a highly effective method of birth control from signing the informed consent form (ICF) until their completion of the study (or 30 days following the last dose of study drug in case of early withdrawal).\n 10. Male patients must use an effective contraception method (e.g., condom with spermicide) from signing the ICF until their completion of the study (or 12 weeks following the last dose of study drug in case of withdrawal) or be congenitally or surgically sterile (e.g., vasectomy with documented confirmation of post-surgical aspermia)\n 11. Willing and able to provide written informed consent prior to any study-related procedures and to comply with all study requirements\n\nPHASE 2:\n\n 1.  Male or female patients aged 18 to 75 years (inclusive)\n 2.  BMI of 18-40 kg/m2\n 3.  Fulfills the 2012 SLICC classification criteria for SLE.\n 4.  Undergoing an ACR-recommended MMF- or MPA-based or Eurolupus CYC-based induction therapy regimen for LN up to 12 weeks prior to randomization, and willing to continue at least the MMF/MPA/CYC portion of the regimen unaltered throughout the duration of the study.\n 5.  The patient has at least one of the following at screening per central lab: 1. Positive ANA test (1:80 or higher) or\n      2. Anti-dsDNA antibodies elevated to above normal (i.e., positive results); or\n      3. Anti-Smith antibody at screening elevated to above normal (i.e., positive results)\n     \n     \n 6.  Kidney biopsy within 52 weeks prior to screening with a histologic diagnosis of LN (International Society of Nephrology/Renal Pathology Society 2003 classification of lupus nephritis [ISN/RPS]) Classes III, IV-S or IV-G, (A) or (A/C); Patients with Class III or IV and concomitant Class V will be permitted\n 7.  UPCR of â‰¥ 1.0 in 24-hour urine collection\n 8.  Acceptable screening laboratory values of concern, including: 1. Adequate hematologic criteria:\n      2. Adequate hepatic function:\n      3. eGFR â‰¥ 40 mL/min/1.73 m2 estimated based on CKD-EPI formula\n      4. IgG â‰¥ 500 mg/dL\n     \n     \n 9.  Women of childbearing potential must have a negative serum beta-hCG pregnancy test at screening and negative urine pregnancy test prior to the first dose and must agree to use a highly effective method of birth control from signing the ICF until their completion of the study (or 30 days following the last dose of study drug in case of early withdrawal).\n 10. Male patients must use an effective contraception method (e.g., condom with spermicide) from signing the ICF until completion of the study (or 12 weeks following the last dose of study drug in case of early withdrawal) or be congenitally or surgically sterile (e.g., vasectomy with documented confirmation of post-surgical aspermia)\n 11. Willing and able to provide written informed consent prior to any study-related procedures and to comply with all study requirements\n\n","\n\nPHASE 1b:\n\n 1. Active central nervous system involvement by autoimmune disease requiring specific therapeutic intervention within 60 days prior to first day of study treatment. Headache treated only with acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs), or approved doses of triptans is permitted with medical monitor approval.\n 2. Presence of another rheumatic (overlap) disease that may confound clinical assessments in the study. Secondary sicca or Sjogren's syndrome, antiphospholipid antibody syndrome, and overlap with rheumatoid arthritis without erosive joint disease (\"rhupus\") are allowed\n 3. History of antiphospholipid syndrome with thromboembolic event within 12 months of screening or not on an adequate anticoagulation regimen. However, presence of antiphospholipid antibodies alone (without a history of thromboembolic event) is not exclusionary.\n 4. Receipt of any of the following treatments within the following timeframes before screening 1.  Systemic corticosteroids â‰¥ 100 mg prednisone or equivalent: 4 weeks\n     2.  Intra-articular therapies, such as corticosteroids or hyaluronic acid preparations: 4 weeks\n     3.  Intravenous Immunoglobulin (IVIg): 4 weeks\n     4.  Other non-biologic immunosuppressive agents, such as cyclosporine, tacrolimus: 4 weeks\n     5.  Cyclophosphamide: 12 weeks\n     6.  Cytokine antagonists: 12 weeks\n     7.  B-cell-depleting therapies (e.g., rituximab): 24 weeks\n     8.  Belimumab, abatacept, or atacicept: 12 weeks\n     9.  Other biologics or investigational drugs: 8 weeks or 5 half-lives, whichever is longer\n     10. Transfusion with blood, packed red blood cells, platelets or treatment with plasmapheresis or plasma exchange: 6 weeks\n    \n    \n 5. Patient has had recent serious or ongoing infection, or risk for serious infection\n 6. History of any concurrent illness that has required treatment with oral or parenteral corticosteroids for more than a total of 2 weeks within the last 24 weeks prior to signing the ICF\n 7. Clinical evidence of significant unstable or uncontrolled acute or chronic diseases that, in the opinion of the investigator or sponsor, could confound the results of the study, put the patient at undue risk, or interfere with protocol adherence\n 8. History of cancer, except for in situ cancer that has been completely excised or has been curatively treated cancer with no sign of disease for > 5 years\n 9. Major surgery within 4 weeks before signing the ICF or major surgery planned during the study period\n\nPHASE 2:\n\n 1.  Active central nervous system involvement by autoimmune disease requiring specific therapeutic intervention within 60 days prior to first day of study treatment. Headache treated only with acetaminophen, NSAIDs, or approved doses of triptans is permitted with medical monitor approval.\n 2.  Isolated Class V membranous LN on a renal biopsy obtained within 52 weeks prior to signing ICF or during the screening period\n 3.  Known intolerance to MMF (or MPA) and CYC\n 4.  History of dialysis within 12 months prior to signing the ICF or expected need for renal replacement therapy (dialysis or renal transplant) within a 6-month period after enrollment\n 5.  History of Rapidly Progressive Glomerulonephritis (RPGN) and/or other renal disease\n 6.  History of chronic kidney disease not directly due to LN\n 7.  Uncontrolled blood pressure (systolic blood pressure â‰¥160 mmHg and diastolic blood pressure â‰¥100 mmHg at rest)o If currently on RAS blockade, dose must be stable for at least 4 weeks prior to screening\n     \n     \n 8.  Receipt of any of the following treatments within the following timeframes before first dose of study treatment: 1.  IVIg: 4 weeks\n      2.  Corticosteroids â‰¥ 1 g/day prednisone or equivalent: 4 weeks\n      3.  Intra-articular therapies, such as corticosteroids or hyaluronic acid preparations: 4 weeks\n      4.  Conventional disease-modifying antirheumatic drugs, including methotrexate, leflunomide, sulfasalazine, cyclosporine, tacrolimus: 12 weeks\n      5.  MMF of â‰¥ 3 g (or 2.16 g of MPA): 4 weeks\n      6.  Cytokine antagonists: 12 weeks\n      7.  B-cell-depleting therapies (e.g., rituximab): 24 weeks\n      8.  Other biologics or investigational drugs: 8 weeks or 5 half-lives, whichever is longer\n      9.  Hydroxychloroquine (>400 mg/day) or chloroquine (>500 mg/day) or other antimalarials above the recommended dose.\n      10. Abatacept: 12 weeks\n      11. NIH (high-dose) CYC or oral CYC: 12 weeks\n     \n     \n 9.  Major surgery within 4 weeks before signing the ICF or major surgery planned during the study period\n 10. History of any other concurrent illness, including drug induced SLE, that has required treatment with oral or parenteral corticosteroids for more than a total of 2 weeks within the last 24 weeks prior to signing the ICF\n 11. Patient has had recent serious or ongoing infection, or risk for serious infection\n 12. Clinical evidence of significant unstable or uncontrolled acute or chronic diseases in the opinion of the investigator\n 13. Any active or suspected malignancy or history of documented malignancy within the last 5 years before Screening, except appropriately excised and cured cervical carcinoma in situ or basal or squamous cell carcinoma of the skin; patients with a history of basal or squamous cell carcinomas of the skin must have had 3 or fewer in their lifetime to be eligible\n 14. Presence of another rheumatic (overlap) disease that nay confound clinical assessment in the study.\n 15. History of antiphospholipid syndrome with history of thromboembolic event within 12 months of screening or not an adequate anticoagulation regimen. However history of antiphospholipid antibodies alone (without history of thromboembolic event) is not exclusionary.","EGFR","epidermal growth factor receptor","Protein","Ovary, Breast, Lung","Actual","2018-01-08","Actual","Anticipated","2021-09-01","Anticipated","2020-01-01","2017-12-21","2018-01-04","2020-01-16",null,"immunoproteasome inhibition\nselective proteasome inhibition\nproteasome\nlupus nephritis\nlupus\nnephritis\nactive proliferative lupus nephritis","Interventional","Treatment","Sequential Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years","75 Years","All",null,"No","Undecided",{"$nulls":3},"Yes","No",{"$nulls":19},"Phase 1 and Phase 2: Safety and Tolerability assessed by monitoring incidence and severity of adverse events (AEs)","Baseline through 37 weeks",null,"Phase 1: Identify Recommended Phase 2 dose levels (RP2Ds) of KZR-616|Phase 1: Peak plasma concentration (Cmax) following injection with KZR-616|Phase 1: Time to peak plasma concentration (Tmax) of KZR-616|Phase 1: Area under the plasma concentration versus time curve (AUC) of KZR-616|Phase 1: Half-life of KZR-616 (T1/2)|Phase 2: The number of patients with a 50% reduction in urine protein to creatinine ratio (UPCR)|Phase 2: The number of patients with a partial renal response|Phase 2: The number of patients with a complete renal response|Phase 2: Change from baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K)|Phase 2: Change from baseline in Levels of Autoantibodies (ANA and anti-dsDNA) and Complement (C3 and C4)|Phase 2: Change from baseline in UPCR|Phase 2: Change from baseline in eGFR|Phase 2: Change from baseline in daily corticosteroid use|Other Pre-specified Outcome Measures:|Phase 1 and 2: Inhibition of chymotrypsin-like (CT-L) activity in whole blood and peripheral blood mononuclear cells (PBMCs);|Phase 1 and 2: Assessment of proteasome sub-unit occupancy in whole blood and PBMCs","Determined through assessment of all AEs and any dose limiting toxicities (DLTs)|Day 1|Day 29|Baseline and every 4 weeks through 25 weeks|UPCR reduction; estimated Glomerular Filtration Rate (eGFR) of â‰¥ 60 mL/min or no worsening of eGFR from baseline of > 20%; No use of prohibited medication|Other Pre-specified Outcome Measures:","4 weeks|Every 4 weeks through 25 weeks","clinicaltrials@kezarbio.com","Clinical Operations","650 822-5600","Clayton, Victoria, Australia, 3168 Kzr Research SiteParkville, Victoria, Australia, 3052|Nedlands, Western Ausrtalia, Australia, 6009|Barranquilla, Atlantico, Colombia|Bucaramanga, Santander, Colombia|Cali, Valle Del Cauca, Colombia|Guadalajara, Jalisco, Mexico|Monterrey, Nuevo Leon, Mexico|Los Angeles, California, United States, 990022 Kzr Research SiteUpland, California, United States, 91786|Coral Gables, Florida, United States, 33134 Kzr Research SiteMiami, Florida, United States, 33136 Kzr Research SiteMiami, Florida, United States, 33165 Kzr Research SiteOrlando, Florida, United States, 32810 Kzr Research SitePalm Harbor, Florida, United States, 34684 Kzr Research SiteTampa, Florida, United States, 33613|Brooklyn, New York, United States, 11203 Kzr Research SiteGreat Neck, New York, United States, 11021 Kzr Research SiteManhasset, New York, United States, 11030 Kzr Research SiteRochester, New York, United States, 14642|Cincinnati, Ohio, United States, 45267 Kzr Research SiteColumbus, Ohio, United States, 43210|Memphis, Tennessee, United States, 38119|Houston, Texas, United States, 77034 Kzr Research SiteHouston, Texas, United States, 77084","California|Florida|New York|Ohio|Tennessee|Texas","Australia|Colombia|Mexico|United States","Victoria Kzr Research Site|Western Ausrtalia Kzr Research Site|Atlantico Kzr Research Site|Santander Kzr Research Site|Valle Del Cauca Kzr Research Site|Jalisco Kzr Research Site|Nuevo Leon Kzr Research Site|Kzr Research Site",{"$nulls":3},"Kezar","2020-01-16","2020-05-25T16:35:40.510","2020-05-26T17:10:42.972","NCT03393013"]
["5ecbf3defeab101b15530811","NCT03393481","2018-01-08","Novartis","NVS","Not yet recruiting","Prevention of Thromboembolic Events in Total Knee Replacement Patients","Maa868|Enoxaparin sodium","FXIa Inhibitor|AT III Activator","Yes","['Maa868']","Yes","['FXIa Inhibitor']","Phase 2",3,600,"Anticipated","2018-01-26","2019-04-30",{"$nulls":5},"The purpose of the study is to find out whether MAA868, is able to prevent blood clots following your medical condition (surgery for knee replacement)",null,"A Multicenter, Randomized, Open-label, Blinded Endpoint Evaluation, Active-controlled Phase 2 Study to Compare the Efficacy and Safety of s.c. MAA868 Versus s.c. Enoxaparin in Adult Patients Undergoing Unilateral Total Knee Arthroplasty","CMAA868A2201","Thrombotic Disorders","Tic Disorders","Neurodevelopmental Disorders","Central Nervous System","Experimental|Active Comparator","MAA868 dose 1|MAA868 dose 2|Enoxaparin","MAA868 dose 1, single administration, subcutaneous|MAA868 dose 2, single administration, subcutaneous|Enoxaparin 40mg, once daily (o.d.) for 10 days","Drug","MAA868|Enoxaparin","MAA868 dose 1 and dose 2, single administration, subcutaneous,|Enoxaparin 40 mg, o.d X 10 days",null,"MAA868 dose 1|MAA868 dose 2|Enoxaparin","\n\n * Scheduled to undergo elective unilateral total knee arthroplayts (TKA)\n * Willing to comply with study requirements including bilateral venography at Day 12 Â± 2 days\n * Body weight between 50 kg and 130 kg inclusive.\n * Normal aPTT, PT, INR at screening\n\n","\n\nHistory of arterial or venous thromboembolism; abnormally extended primary or secondary bleeding after trauma or intervention, stroke, transient ischemic attack or traumatic or non-traumatic intracranial bleed; bleeding disorder; MI or unstable angina pectoris within 12 months of the screening; Uncontrolled hypertension (SBP/DBP â‰¥ 150/95 mmHg at the screening).\n\nMedications that increase the risk of bleeding, including antiplatelet (such as aspirin), anticoagulant and fibrinolytic agents; eGFR < 60 mL/min/1.73m2; Poorly controlled diabetes (HbA1C >10%); Liver dysfunction (ALT/AST >3 xULN or TBL >2 x ULN); BMI â‰¥ 40 kg/m2",{"$nulls":4},"Actual","2018-01-08","Actual","Anticipated","2019-04-30","Anticipated","2017-08-01","2018-01-03","2018-01-03","2018-01-03","Yes","biologic,\nvenous thromboembolism,\nunilateral knee arthroplasty","Interventional","Prevention","Parallel Assignment","Single (Outcomes Assessor)","Randomized",null,"80 Years","All",null,"No","Undecided\nNovartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.\n\nThis trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",{"$nulls":3},"No","No",{"$nulls":17},"2017-002925-39","EudraCT Number","Number of patients with confirmed composite endpoint","Occurrence of confirmed composite endpoint of asymptomatic deep vein thrombosis (DVT), confirmed symptomatic venous thromboembolic events (VTE), fatal pulmonary embolism (PE) or unexplained death","Day 14","Number of patients with composite bleeding|Number of patients with composite venous thromboembolic events (VTE)","Occurrence of confirmed composite endpoint of major bleeding and clinically relevant non-major (CRNM) bleeding events|Occurrence of confirmed composite endpoint of asymptomatic deep vein thrombosis (DVT), Confirmed symptomatic venous thromboembolic events (VTE), fatal pulmonary embolism (PE) or unexplained death","Day 1 to Day 50|Day 1 to Day 110",{"$nulls":11},"2018-01-03","2020-05-25T16:35:42.013","2020-05-26T17:10:42.972","NCT03393481"]
["5ecbf3defeab101b15530812","NCT03393481","2018-03-29","Novartis","NVS","Not yet recruiting","Prevention of Thromboembolic Events in Total Knee Replacement Patients","Maa868|Enoxaparin sodium","FXIa Inhibitor|AT III Activator","Yes","['Maa868']","Yes","['FXIa Inhibitor']","Phase 2",3,600,"Anticipated","2018-04-06","2019-10-22",{"$nulls":5},"The purpose of the study is to find out whether MAA868, is able to prevent blood clots following your medical condition (surgery for knee replacement)",null,"A Multicenter, Randomized, Open-label, Blinded Endpoint Evaluation, Active-controlled Phase 2 Study to Compare the Efficacy and Safety of s.c. MAA868 Versus s.c. Enoxaparin in Adult Patients Undergoing Unilateral Total Knee Arthroplasty","CMAA868A2201","Thrombotic Disorders","Tic Disorders","Neurodevelopmental Disorders","Central Nervous System","Experimental|Active Comparator","MAA868 dose 1|MAA868 dose 2|Enoxaparin","MAA868 dose 1, single administration, subcutaneous|MAA868 dose 2, single administration, subcutaneous|Enoxaparin 40mg, once daily (o.d.) for 10 days","Drug","MAA868|Enoxaparin","MAA868 dose 1 and dose 2, single administration, subcutaneous,|Enoxaparin 40 mg, o.d X 10 days",null,"MAA868 dose 1|MAA868 dose 2|Enoxaparin","\n\n * Scheduled to undergo elective unilateral total knee arthroplayts (TKA)\n * Willing to comply with study requirements including bilateral venography at Day 12 Â± 2 days\n * Body weight between 50 kg and 130 kg inclusive.\n * Normal aPTT, PT, INR at screening\n\n","\n\nHistory of arterial or venous thromboembolism; abnormally extended primary or secondary bleeding after trauma or intervention, stroke, transient ischemic attack or traumatic or non-traumatic intracranial bleed; bleeding disorder; MI or unstable angina pectoris within 12 months of the screening; Uncontrolled hypertension (SBP/DBP â‰¥ 150/95 mmHg at the screening).\n\nMedications that increase the risk of bleeding, including antiplatelet (such as aspirin), anticoagulant and fibrinolytic agents; eGFR < 60 mL/min/1.73m2; Poorly controlled diabetes (HbA1C >10%); Liver dysfunction (ALT/AST >3 xULN or TBL >2 x ULN); BMI â‰¥ 40 kg/m2",{"$nulls":4},"Actual","2018-01-08","Actual","Anticipated","2019-10-22","Anticipated","2018-03-01","2018-01-03","2018-01-03","2018-03-28","Yes","biologic,\nvenous thromboembolism,\nunilateral knee arthroplasty","Interventional","Prevention","Parallel Assignment","Single (Outcomes Assessor)","Randomized",null,"80 Years","All",null,"No","Undecided\nNovartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.\n\nThis trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",{"$nulls":3},"No","No",{"$nulls":17},"2017-002925-39","EudraCT Number","Number of patients with confirmed composite endpoint","Occurrence of confirmed composite endpoint of asymptomatic deep vein thrombosis (DVT), confirmed symptomatic venous thromboembolic events (VTE), fatal pulmonary embolism (PE) or unexplained death","Day 14","Number of patients with composite bleeding|Number of patients with composite venous thromboembolic events (VTE)","Occurrence of confirmed composite endpoint of major bleeding and clinically relevant non-major (CRNM) bleeding events|Occurrence of confirmed composite endpoint of asymptomatic deep vein thrombosis (DVT), Confirmed symptomatic venous thromboembolic events (VTE), fatal pulmonary embolism (PE) or unexplained death","Day 1 to Day 50|Day 1 to Day 110",{"$nulls":11},"2018-03-28","2020-05-25T16:35:42.548","2020-05-26T17:10:42.972","NCT03393481"]
["5ecbf3ddfe30261b1a0481e1","NCT03393481","2018-05-15","Novartis","NVS","Not yet recruiting","Prevention of Thromboembolic Events in Total Knee Replacement Patients","Maa868|Enoxaparin sodium","FXIa Inhibitor|AT III Activator","Yes","['Maa868']","Yes","['FXIa Inhibitor']","Phase 2",3,600,"Anticipated","2018-10-03","2020-01-08",{"$nulls":5},"The purpose of the study is to find out whether MAA868, is able to prevent blood clots following your medical condition (surgery for knee replacement)",null,"A Multicenter, Randomized, Open-label, Blinded Endpoint Evaluation, Active-controlled Phase 2 Study to Compare the Efficacy and Safety of s.c. MAA868 Versus s.c. Enoxaparin in Adult Patients Undergoing Unilateral Total Knee Arthroplasty","CMAA868A2201","Thrombotic Disorders","Tic Disorders","Neurodevelopmental Disorders","Central Nervous System","Experimental|Active Comparator","MAA868 dose 1|MAA868 dose 2|Enoxaparin","MAA868 dose 1, single administration, subcutaneous|MAA868 dose 2, single administration, subcutaneous|Enoxaparin 40mg, once daily (o.d.) for 10 days","Drug","MAA868|Enoxaparin","MAA868 dose 1 and dose 2, single administration, subcutaneous,|Enoxaparin 40 mg, o.d X 10 days",null,"MAA868 dose 1|MAA868 dose 2|Enoxaparin","\n\n * Scheduled to undergo elective unilateral total knee arthroplayts (TKA)\n * Willing to comply with study requirements including bilateral venography at Day 12 Â± 2 days\n * Body weight between 50 kg and 130 kg inclusive.\n * Normal aPTT, PT, INR at screening\n\n","\n\nHistory of arterial or venous thromboembolism; abnormally extended primary or secondary bleeding after trauma or intervention, stroke, transient ischemic attack or traumatic or non-traumatic intracranial bleed; bleeding disorder; MI or unstable angina pectoris within 12 months of the screening; Uncontrolled hypertension (SBP/DBP â‰¥ 150/95 mmHg at the screening).\n\nMedications that increase the risk of bleeding, including antiplatelet (such as aspirin), anticoagulant and fibrinolytic agents; eGFR < 60 mL/min/1.73m2; Poorly controlled diabetes (HbA1C >10%); Liver dysfunction (ALT/AST >3 xULN or TBL >2 x ULN); BMI â‰¥ 40 kg/m2",{"$nulls":4},"Actual","2018-01-08","Actual","Anticipated","2020-04-17","Anticipated","2018-05-01","2018-01-03","2018-01-03","2018-05-09","Yes","biologic,\nvenous thromboembolism,\nunilateral knee arthroplasty","Interventional","Prevention","Parallel Assignment","Single (Outcomes Assessor)","N/A","18 Years","80 Years","All",null,"No","Undecided\nNovartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.\n\nThis trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",{"$nulls":3},"No","No",{"$nulls":17},"2017-002925-39","EudraCT Number","Number of patients with confirmed composite endpoint","Occurrence of confirmed composite endpoint of asymptomatic deep vein thrombosis (DVT), confirmed symptomatic venous thromboembolic events (VTE), fatal pulmonary embolism (PE) or unexplained death","Day 14","Number of patients with composite bleeding|Number of patients with composite venous thromboembolic events (VTE)","Occurrence of confirmed composite endpoint of major bleeding and clinically relevant non-major (CRNM) bleeding events|Occurrence of confirmed composite endpoint of asymptomatic deep vein thrombosis (DVT), Confirmed symptomatic venous thromboembolic events (VTE), fatal pulmonary embolism (PE) or unexplained death","Day 1 to Day 50|Day 1 to Day 110",{"$nulls":11},"2018-05-09","2020-05-25T16:35:41.941","2020-05-26T17:10:42.972","NCT03393481"]
["5ecbf3dee2561b1b11905cdd","NCT03393481","2018-09-12","Novartis","NVS","Withdrawn","Prevention of Thromboembolic Events in Total Knee Replacement Patients","Maa868|Enoxaparin sodium","FXIa Inhibitor|AT III Activator","Yes","['Maa868']","Yes","['FXIa Inhibitor']","Phase 2",3,0,"Actual","2018-10-03","2020-01-08",{"$nulls":5},"The purpose of the study is to find out whether MAA868, is able to prevent blood clots following your medical condition (surgery for knee replacement)",null,"A Multicenter, Randomized, Open-label, Blinded Endpoint Evaluation, Active-controlled Phase 2 Study to Compare the Efficacy and Safety of s.c. MAA868 Versus s.c. Enoxaparin in Adult Patients Undergoing Unilateral Total Knee Arthroplasty","CMAA868A2201","Thrombotic Disorders","Tic Disorders","Neurodevelopmental Disorders","Central Nervous System","Experimental|Active Comparator","MAA868 dose 1|MAA868 dose 2|Enoxaparin","MAA868 dose 1, single administration, subcutaneous|MAA868 dose 2, single administration, subcutaneous|Enoxaparin 40mg, once daily (o.d.) for 10 days","Drug","MAA868|Enoxaparin","MAA868 dose 1 and dose 2, single administration, subcutaneous,|Enoxaparin 40 mg, o.d X 10 days",null,"MAA868 dose 1|MAA868 dose 2|Enoxaparin","\n\n * Scheduled to undergo elective unilateral total knee arthroplayts (TKA)\n * Willing to comply with study requirements including bilateral venography at Day 12 Â± 2 days\n * Body weight between 50 kg and 130 kg inclusive.\n * Normal aPTT, PT, INR at screening\n\n","\n\nHistory of arterial or venous thromboembolism; abnormally extended primary or secondary bleeding after trauma or intervention, stroke, transient ischemic attack or traumatic or non-traumatic intracranial bleed; bleeding disorder; MI or unstable angina pectoris within 12 months of the screening; Uncontrolled hypertension (SBP/DBP â‰¥ 150/95 mmHg at the screening).\n\nMedications that increase the risk of bleeding, including antiplatelet (such as aspirin), anticoagulant and fibrinolytic agents; eGFR < 60 mL/min/1.73m2; Poorly controlled diabetes (HbA1C >10%); Liver dysfunction (ALT/AST >3 xULN or TBL >2 x ULN); BMI â‰¥ 40 kg/m2",{"$nulls":4},"Actual","2018-01-08","Actual","Anticipated","2020-04-17","Anticipated","2018-09-01","2018-01-03","2018-01-03","2018-09-10","Yes","biologic,\nvenous thromboembolism,\nunilateral knee arthroplasty","Interventional","Prevention","Parallel Assignment","Single (Outcomes Assessor)","N/A","18 Years","80 Years","All",null,"No","Undecided\nNovartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.\n\nThis trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",{"$nulls":3},"No","No",{"$nulls":17},"2017-002925-39","EudraCT Number","Number of patients with confirmed composite endpoint","Occurrence of confirmed composite endpoint of asymptomatic deep vein thrombosis (DVT), confirmed symptomatic venous thromboembolic events (VTE), fatal pulmonary embolism (PE) or unexplained death","Day 14","Number of patients with composite bleeding|Number of patients with composite venous thromboembolic events (VTE)","Occurrence of confirmed composite endpoint of major bleeding and clinically relevant non-major (CRNM) bleeding events|Occurrence of confirmed composite endpoint of asymptomatic deep vein thrombosis (DVT), Confirmed symptomatic venous thromboembolic events (VTE), fatal pulmonary embolism (PE) or unexplained death","Day 1 to Day 50|Day 1 to Day 110",{"$nulls":11},"2018-09-10","2020-05-25T16:35:42.057","2020-05-26T17:10:42.972","NCT03393481"]
["5ecbf3dd11702c1b1b9169f3","NCT03393494","2018-01-08","Perrigo","PRGO","Recruiting","Bioequivalence Study of Two Treatments in the Treatment of Acne Vulgaris on the Face","Adapalene|Benzoyl peroxide","RAR Agonist|Cutibacterium acne Inhibitor","No",null,"No",null,"Phase 3",3,825,"Anticipated","2017-12-13","2018-09-01",{"$nulls":5},"To compare the safety and efficacy of Perrigo's product to an FDA approved product for the treatment of Acne Vulgaris",null,"Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study to Compare Perrigo's Adapalene/BP Gel to Galderma's Epiduo (Adapalene/BP) Gel, and Both Treatments to a Vehicle Control in the Treatment of Acne Vulgaris","PRG-NY-17-008","Acne Vulgaris","Acne Vulgaris","Dermatological Diseases","Derm & Connective Tissue Disorders","Experimental|Active Comparator|Placebo Comparator","Perrigo active|Reference active|Perrigo placebo","Test product|RLD product|placebo product","Drug","Adapalene and Benzoyl Peroxide Topical Gel|Epiduo Topical Product|Placebo","Test product|RLD product|Placebo gel",null,"Perrigo active|Reference active|Perrigo placebo","\n\n 1. Signed IRB approved written informed consent/assent\n 2. 12 to 40 years of age, inclusive.\n 3. Clinical diagnosis of facial acne vulgaris with an inflammatory lesion (papules and pustules) count of 20-50, inclusive and a non-inflammatory (open and closed comedones) lesion count of 25-100 inclusive and no more than 2 nodulocystic lesions (e.g., nodules and cysts) including those present on the nose.\n 4. Baseline Investigator's Global Assessment Score of 3 (moderate) or 4 (severe) on a severity scale of 0 to 4.\n 5. Females of child bearing potential (excluding women who are surgically sterilized (tubal ligation or bilateral oophorectomy or hysterectomy) or post-menopausal for at least 2 years), in addition to having a negative urine pregnancy test at Visit 1/Day1(Baseline), must be willing to use an acceptable form of birth control during the study.\n\n","\n\n 1.  Pregnant, breastfeeding or planning a pregnancy within the period of their study participation period.\n 2.  Presence of more than 2 facial Nodulocystic lesions.\n 3.  Presence of any other facial skin condition that, in the Investigator's opinion, might interfere with acne vulgaris diagnosis and/or evaluations\n 4.  Any uncontrolled, chronic or serious disease or medical condition that would prevent participation in a clinical trial, or, in judgment of the investigator, would put the subject at undue risk or might confound the study assessments\n 5.  Excessive facial hair that would interfere with the diagnosis or assessment of acne vulgaris.\n 6.  History of unresponsiveness to topical adapalene and/or benzoyl peroxide therapy.\n 7.  Currently using any product containing adapalene and/or benzoyl peroxide and/or belonging to the same family.\n 8.  History of hypersensitivity or allergy to adapalene, benzoyl peroxide, retinoids and/or any ingredient in the study medication.\n 9.  Use of medications known to exacerbate acne\n 10. Start or change within 3 months (90 days) of Visit 1 and throughout the study\n 11. Use of medicated make-up throughout the study and significant change in the use of consumer products within 30 days (1 month) of study entry and throughout the study\n 12. Subject consumes excessive alcohol, abuses drugs, or has a condition that could compromise the subject's ability to comply with study requirements.\n 13. Subjects who in the opinion of the investigator, are unlikely to be able to follow the restrictions of the protocol and complete the study.",{"$nulls":4},"Actual","2018-01-08","Actual","Anticipated","2018-11-01","Anticipated","2018-01-01","2018-01-03","2018-01-03","2018-01-03","No",null,"Interventional","Treatment","Parallel Assignment","Double (Participant, Investigator)","Randomized","12 Years","40 Years","All",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":14},"Mean percent change from baseline in the inflammatory (papules and pustules) lesion count|Mean percent change from baseline in the non-inflammatory (open and closed comedones) lesion count","12 weeks",{"$nulls":7},"High Point, North Carolina, United States, 27262","North Carolina","United States","Dermatology Consultants",{"$nulls":4},"2018-01-03","2020-05-25T16:35:41.629","2020-05-26T17:10:42.972","NCT03393494"]
["5ecbf3dde2561b1b11905cdc","NCT03393494","2019-01-09","Perrigo","PRGO","Completed","Bioequivalence Study of Two Treatments in the Treatment of Acne Vulgaris on the Face","Adapalene|Benzoyl peroxide","RAR Agonist|Cutibacterium acne Inhibitor","No",null,"No",null,"Phase 3",3,825,"Actual","2017-12-13","2018-09-30",{"$nulls":5},"To compare the safety and efficacy of Perrigo's product to an FDA approved product for the treatment of Acne Vulgaris",null,"Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study to Compare Perrigo's Adapalene/BP Gel to Galderma's Epiduo (Adapalene/BP) Gel, and Both Treatments to a Vehicle Control in the Treatment of Acne Vulgaris","PRG-NY-17-008","Acne Vulgaris","Acne Vulgaris","Dermatological Diseases","Derm & Connective Tissue Disorders","Experimental|Active Comparator|Placebo Comparator","Perrigo active|Reference active|Perrigo placebo","Test product|RLD product|placebo product","Drug","Adapalene and Benzoyl Peroxide Topical Gel|Epiduo Topical Product|Placebo","Test product|RLD product|Placebo gel",null,"Perrigo active|Reference active|Perrigo placebo","\n\n 1. Signed IRB approved written informed consent/assent\n 2. 12 to 40 years of age, inclusive.\n 3. Clinical diagnosis of facial acne vulgaris with an inflammatory lesion (papules and pustules) count of 20-50, inclusive and a non-inflammatory (open and closed comedones) lesion count of 25-100 inclusive and no more than 2 nodulocystic lesions (e.g., nodules and cysts) including those present on the nose.\n 4. Baseline Investigator's Global Assessment Score of 3 (moderate) or 4 (severe) on a severity scale of 0 to 4.\n 5. Females of child bearing potential (excluding women who are surgically sterilized (tubal ligation or bilateral oophorectomy or hysterectomy) or post-menopausal for at least 2 years), in addition to having a negative urine pregnancy test at Visit 1/Day1(Baseline), must be willing to use an acceptable form of birth control during the study.\n\n","\n\n 1.  Pregnant, breastfeeding or planning a pregnancy within the period of their study participation period.\n 2.  Presence of more than 2 facial Nodulocystic lesions.\n 3.  Presence of any other facial skin condition that, in the Investigator's opinion, might interfere with acne vulgaris diagnosis and/or evaluations\n 4.  Any uncontrolled, chronic or serious disease or medical condition that would prevent participation in a clinical trial, or, in judgment of the investigator, would put the subject at undue risk or might confound the study assessments\n 5.  Excessive facial hair that would interfere with the diagnosis or assessment of acne vulgaris.\n 6.  History of unresponsiveness to topical adapalene and/or benzoyl peroxide therapy.\n 7.  Currently using any product containing adapalene and/or benzoyl peroxide and/or belonging to the same family.\n 8.  History of hypersensitivity or allergy to adapalene, benzoyl peroxide, retinoids and/or any ingredient in the study medication.\n 9.  Use of medications known to exacerbate acne\n 10. Start or change within 3 months (90 days) of Visit 1 and throughout the study\n 11. Use of medicated make-up throughout the study and significant change in the use of consumer products within 30 days (1 month) of study entry and throughout the study\n 12. Subject consumes excessive alcohol, abuses drugs, or has a condition that could compromise the subject's ability to comply with study requirements.\n 13. Subjects who in the opinion of the investigator, are unlikely to be able to follow the restrictions of the protocol and complete the study.",{"$nulls":4},"Actual","2018-01-08","Actual","Actual","2019-01-05","Actual","2019-01-01","2018-01-03","2018-01-03","2019-01-08","No",null,"Interventional","Treatment","Parallel Assignment","Double (Participant, Investigator)","Randomized","12 Years","40 Years","All",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":14},"Mean percent change from baseline in the inflammatory (papules and pustules) lesion count|Mean percent change from baseline in the non-inflammatory (open and closed comedones) lesion count","12 weeks",{"$nulls":7},"High Point, North Carolina, United States, 27262","North Carolina","United States","Dermatology Consultants",{"$nulls":4},"2019-01-08","2020-05-25T16:35:41.692","2020-05-26T17:10:42.972","NCT03393494"]
["5ecbf3dd11702c1b1b9169f4","NCT03393494","2019-10-17","Perrigo","PRGO","Completed","Bioequivalence Study of Two Treatments in the Treatment of Acne Vulgaris on the Face","Adapalene|Benzoyl peroxide","RAR Agonist|Cutibacterium acne Inhibitor","No",null,"No",null,"Phase 3",3,825,"Actual","2017-12-13","2018-09-30",{"$nulls":5},"To compare the safety and efficacy of Perrigo's product to an FDA approved product for the treatment of Acne Vulgaris",null,"Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study to Compare Perrigo's Adapalene/BP Gel to Galderma's Epiduo (Adapalene/BP) Gel, and Both Treatments to a Vehicle Control in the Treatment of Acne Vulgaris","PRG-NY-17-008","Acne Vulgaris","Acne Vulgaris","Dermatological Diseases","Derm & Connective Tissue Disorders","Experimental|Active Comparator|Placebo Comparator","Perrigo active|Reference active|Perrigo placebo","Test product|RLD product|placebo product","Drug","Adapalene and Benzoyl Peroxide Topical Gel|Epiduo Topical Product|Placebo","Test product|RLD product|Placebo gel",null,"Perrigo active|Reference active|Perrigo placebo","\n\n 1. Signed IRB approved written informed consent/assent\n 2. 12 to 40 years of age, inclusive.\n 3. Clinical diagnosis of facial acne vulgaris with an inflammatory lesion (papules and pustules) count of 20-50, inclusive and a non-inflammatory (open and closed comedones) lesion count of 25-100 inclusive and no more than 2 nodulocystic lesions (e.g., nodules and cysts) including those present on the nose.\n 4. Baseline Investigator's Global Assessment Score of 3 (moderate) or 4 (severe) on a severity scale of 0 to 4.\n 5. Females of child bearing potential (excluding women who are surgically sterilized (tubal ligation or bilateral oophorectomy or hysterectomy) or post-menopausal for at least 2 years), in addition to having a negative urine pregnancy test at Visit 1/Day1(Baseline), must be willing to use an acceptable form of birth control during the study.\n\n","\n\n 1.  Pregnant, breastfeeding or planning a pregnancy within the period of their study participation period.\n 2.  Presence of more than 2 facial Nodulocystic lesions.\n 3.  Presence of any other facial skin condition that, in the Investigator's opinion, might interfere with acne vulgaris diagnosis and/or evaluations\n 4.  Any uncontrolled, chronic or serious disease or medical condition that would prevent participation in a clinical trial, or, in judgment of the investigator, would put the subject at undue risk or might confound the study assessments\n 5.  Excessive facial hair that would interfere with the diagnosis or assessment of acne vulgaris.\n 6.  History of unresponsiveness to topical adapalene and/or benzoyl peroxide therapy.\n 7.  Currently using any product containing adapalene and/or benzoyl peroxide and/or belonging to the same family.\n 8.  History of hypersensitivity or allergy to adapalene, benzoyl peroxide, retinoids and/or any ingredient in the study medication.\n 9.  Use of medications known to exacerbate acne\n 10. Start or change within 3 months (90 days) of Visit 1 and throughout the study\n 11. Use of medicated make-up throughout the study and significant change in the use of consumer products within 30 days (1 month) of study entry and throughout the study\n 12. Subject consumes excessive alcohol, abuses drugs, or has a condition that could compromise the subject's ability to comply with study requirements.\n 13. Subjects who in the opinion of the investigator, are unlikely to be able to follow the restrictions of the protocol and complete the study.",{"$nulls":4},"Actual","2018-01-08","Actual","Actual","2019-01-05","Actual","2019-10-01","2018-01-03","2018-01-03","2019-10-08","No",null,"Interventional","Treatment","Parallel Assignment","Double (Participant, Investigator)","Randomized","12 Years","40 Years","All",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":4},"No",null,null,43746,43746,"October 17, 2019 [Actual]",{"$nulls":9},"Mean percent change from baseline in the inflammatory (papules and pustules) lesion count|Mean percent change from baseline in the non-inflammatory (open and closed comedones) lesion count","12 weeks",{"$nulls":7},"High Point, North Carolina, United States, 27262","North Carolina","United States","Dermatology Consultants",{"$nulls":4},"2019-10-08","2020-05-25T16:35:41.918","2020-05-26T17:10:42.972","NCT03393494"]
["5ecbf3de307e3d1b1f8d9c72","NCT03393520","2018-01-08","Avanir","AVNR","Recruiting","Assessment of the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type","Avp-786",null,"Yes","['Avp-786']","Unknown",null,"Phase 3",3,412,"Anticipated","2017-10-13","2020-03-01",{"$nulls":5},"This study will be conducted to evaluate the efficacy, safety, and tolerability of AVP-786 compared to placebo, for the treatment of agitation in participants with dementia of the Alzheimer's type.","Eligible participants for this study must have a diagnosis of probable Alzheimer's disease (AD) and must have clinically significant, moderate/severe agitation secondary to AD.\n\nThis is a multicenter, randomized, double-blind, placebo-controlled, parallel-design study, consisting of 12 weeks of treatment.\n\nApproximately 412 participants will be enrolled at approximately 70 centers in global geographies outside of the United States.\n\nStudy medication will be administered orally twice-daily from Day 1 through Day 85. Screening will occur within approximately 4 weeks prior to randomization. Following screening procedures for assessment of inclusion and exclusion criteria, eligible participants will be randomized into the study.","A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-design Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type","17-AVP-786-305","Agitation in Patients With Dementia of the Alzheimer's Type","Alzheimer Disease|Dementia","Neurocognitive Disorders","Central Nervous System","Placebo Comparator|Experimental","Placebo|AVP-786; Dose 1|AVP-786; Dose 2","Participants will be assigned to treatment with placebo capsules administered twice a day over a 12-week period.|Participants will receive AVP-786 (Dose 1) capsules administered twice a day over a 12-week period.|Participants will receive AVP-786 (Dose 2) capsules administered twice a day over a 12-week period.","Drug","Placebo|AVP-786","oral capsules",null,"Placebo|AVP-786; Dose 1|AVP-786; Dose 2","\n\n * Diagnosis of probable Alzheimer's Disease (AD) according to the 2011 National Institute on Aging-Alzheimer's Association (NIA-AA) working groups criteria\n * Participants with clinically significant, moderate/severe agitation at the time of screening and for at least 2 weeks prior to randomization that interferes with their daily routine and for which a prescription medication has been indicated, in the opinion of the investigator\n * The diagnosis of agitation must meet the provisional consensus definition of agitation in participants with cognitive disorders developed by the International Psychogeriatric Association (IPA) Agitation Definition Work Group.\n * A Clinical Global Impression of Severity of Illness scale for Agitation (CGIS-Agitation) score of â‰¥ 4 (moderately ill) at screening and baseline\n * Participants must have a reliable caregiver who is able and willing to comply with study procedures, including not administering any prohibited medications during the course of the study.\n * Caregiver who is able and willing to comply with all required study procedures. In order to qualify as a reliable informant (i.e., caregiver) capable of assessing changes in participant's condition during the study, the individual must spend a minimum of 2 hours per day for 4 days per week with the participant.\n\n","\n\n * Participants with dementia predominantly of the non-Alzheimer's type (e.g., vascular dementia, frontotemporal dementia, Parkinson's disease, substance-induced dementia)\n * Participants with symptoms of agitation that are not secondary to AD (e.g., secondary to pain, other psychiatric disorder, or delirium)\n * Participants with co-existent clinically significant or unstable systemic diseases that could confound the interpretation of the safety results of the study (e.g., malignancy, poorly controlled diabetes, poorly controlled hypertension, unstable pulmonary, renal or hepatic disease, unstable ischemic cardiac disease, dilated cardiomyopathy, or unstable valvular heart disease)\n * Participants with myasthenia gravis",{"$nulls":4},"Actual","2018-01-08","Actual","Anticipated","2020-03-01","Anticipated","2018-01-01","2018-01-03","2018-01-03","2018-01-03","Yes","Agitation\nDementia of the Alzheimer's type\nAlzheimer's disease\nAVP-786\nDeudextromethorphan hydrobromide\nQuinidine sulfate","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","50 Years","90 Years","All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"2017-001339-38","EudraCT Number","Change from Baseline to Week 12 in the Cohen-Mansfield Agitation Inventory (CMAI) Composite Score","Baseline; Week 12",null,"Change from Baseline to Week 12 in the Modified Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change for Agitation (mADCS-CGIC-Agitation) Score|Change from Baseline to Week 12 in the Neuropsychiatric Inventory (NPI) Agitation/Aggression Domain Score|Change from Baseline to Week 12 in the NPI Caregiver Distress Score|Change from Baseline to Week 12 in the NPI Aberrant Motor Behavior Domain Score|Change from Baseline to Week 12 in the NPI Irritability/Lability Domain Score|Change from Baseline to Week 12 in the NPI Total Score|Change from Baseline to Week 12 in the Clinical Global Impression of Severity (CGIS)-Agitation Domain Score|Change from Baseline to Week 12 in the ADCS-CGIC for Overall Clinical Status Rating|Change from Baseline to Week 12 in the Patient Global Impression of Change (PGIC) Scale Score|Change from Baseline to Week 12 in the Dementia Quality of Life (DEMQOL) Scale Score|Change from Baseline to Week 12 in EuroQol-5 Dimension-5 Level (EQ-5D-5L) Dimension Scores|Change from Baseline to Week 12 in the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) Score|Change from Baseline to Week 12 in the Resource Utilization in Dementia (RUD) Scale Score","Baseline; Week 12",{"$nulls":4},"Nedlands, Australia",null,"Australia","Australian Alzheimer's Research Foundation",{"$nulls":4},"2018-01-03","2020-05-25T16:35:42.208","2020-05-26T17:10:42.972","NCT03393520"]
["5ecbf3defe30261b1a0481e3","NCT03393520","2018-03-14","Avanir","AVNR","Recruiting","Assessment of the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type","Avp-786",null,"Yes","['Avp-786']","Unknown",null,"Phase 3",3,412,"Anticipated","2017-10-13","2020-03-01",{"$nulls":5},"This study will be conducted to evaluate the efficacy, safety, and tolerability of AVP-786 compared to placebo, for the treatment of agitation in participants with dementia of the Alzheimer's type.","Eligible participants for this study must have a diagnosis of probable Alzheimer's disease (AD) and must have clinically significant, moderate/severe agitation secondary to AD.\n\nThis is a multicenter, randomized, double-blind, placebo-controlled, parallel-design study, consisting of 12 weeks of treatment.\n\nApproximately 412 participants will be enrolled at approximately 70 centers in global geographies outside of the United States.\n\nStudy medication will be administered orally twice-daily from Day 1 through Day 85. Screening will occur within approximately 4 weeks prior to randomization. Following screening procedures for assessment of inclusion and exclusion criteria, eligible participants will be randomized into the study.","A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-design Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type","17-AVP-786-305","Agitation in Patients With Dementia of the Alzheimer's Type","Alzheimer Disease|Dementia","Neurocognitive Disorders","Central Nervous System","Placebo Comparator|Experimental","Placebo|AVP-786; Dose 1|AVP-786; Dose 2","Participants will be assigned to treatment with placebo capsules administered twice a day over a 12-week period.|Participants will receive AVP-786 (Dose 1) capsules administered twice a day over a 12-week period.|Participants will receive AVP-786 (Dose 2) capsules administered twice a day over a 12-week period.","Drug","Placebo|AVP-786","oral capsules",null,"Placebo|AVP-786; Dose 1|AVP-786; Dose 2","\n\n * Diagnosis of probable Alzheimer's Disease (AD) according to the 2011 National Institute on Aging-Alzheimer's Association (NIA-AA) working groups criteria\n * Participants with clinically significant, moderate/severe agitation at the time of screening and for at least 2 weeks prior to randomization that interferes with their daily routine and for which a prescription medication has been indicated, in the opinion of the investigator\n * The diagnosis of agitation must meet the provisional consensus definition of agitation in participants with cognitive disorders developed by the International Psychogeriatric Association (IPA) Agitation Definition Work Group.\n * A Clinical Global Impression of Severity of Illness scale for Agitation (CGIS-Agitation) score of â‰¥ 4 (moderately ill) at screening and baseline\n * Participants must have a reliable caregiver who is able and willing to comply with study procedures, including not administering any prohibited medications during the course of the study.\n * Caregiver who is able and willing to comply with all required study procedures. In order to qualify as a reliable informant (i.e., caregiver) capable of assessing changes in participant's condition during the study, the individual must spend a minimum of 2 hours per day for 4 days per week with the participant.\n\n","\n\n * Participants with dementia predominantly of the non-Alzheimer's type (e.g., vascular dementia, frontotemporal dementia, Parkinson's disease, substance-induced dementia)\n * Participants with symptoms of agitation that are not secondary to AD (e.g., secondary to pain, other psychiatric disorder, or delirium)\n * Participants with co-existent clinically significant or unstable systemic diseases that could confound the interpretation of the safety results of the study (e.g., malignancy, poorly controlled diabetes, poorly controlled hypertension, unstable pulmonary, renal or hepatic disease, unstable ischemic cardiac disease, dilated cardiomyopathy, or unstable valvular heart disease)\n * Participants with myasthenia gravis",{"$nulls":4},"Actual","2018-01-08","Actual","Anticipated","2020-03-01","Anticipated","2018-03-01","2018-01-03","2018-01-03","2018-03-12","Yes","Agitation\nDementia of the Alzheimer's type\nAlzheimer's disease\nAVP-786\nDeudextromethorphan hydrobromide\nQuinidine sulfate","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","50 Years","90 Years","All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"2017-001339-38","EudraCT Number","Change from Baseline to Week 12 in the Cohen-Mansfield Agitation Inventory (CMAI) Composite Score","Baseline; Week 12",null,"Change from Baseline to Week 12 in the Modified Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change for Agitation (mADCS-CGIC-Agitation) Score|Change from Baseline to Week 12 in the Neuropsychiatric Inventory (NPI) Agitation/Aggression Domain Score|Change from Baseline to Week 12 in the NPI Caregiver Distress Score|Change from Baseline to Week 12 in the NPI Aberrant Motor Behavior Domain Score|Change from Baseline to Week 12 in the NPI Irritability/Lability Domain Score|Change from Baseline to Week 12 in the NPI Total Score|Change from Baseline to Week 12 in the Clinical Global Impression of Severity (CGIS)-Agitation Domain Score|Change from Baseline to Week 12 in the ADCS-CGIC for Overall Clinical Status Rating|Change from Baseline to Week 12 in the Patient Global Impression of Change (PGIC) Scale Score|Change from Baseline to Week 12 in the Dementia Quality of Life (DEMQOL) Scale Score|Change from Baseline to Week 12 in EuroQol-5 Dimension-5 Level (EQ-5D-5L) Dimension Scores|Change from Baseline to Week 12 in the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) Score|Change from Baseline to Week 12 in the Resource Utilization in Dementia (RUD) Scale Score","Baseline; Week 12",{"$nulls":4},"Nedlands, Australia Neuro Trials Victoria Pty LtdNoble Park, Australia|Nyiregyhaza, Hungary",null,"Australia|Hungary","Australian Alzheimer's Research Foundation|Szabolcs-Szatmar-Bereg Megyei Korhazak Es Egyetemi Oktatokorhaz",{"$nulls":4},"2018-03-12","2020-05-25T16:35:42.622","2020-05-26T17:10:42.972","NCT03393520"]
["5ecbf3defe30261b1a0481e2","NCT03393520","2018-05-01","Avanir","AVNR","Recruiting","Assessment of the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type","Avp-786",null,"Yes","['Avp-786']","Unknown",null,"Phase 3",3,412,"Anticipated","2017-10-13","2020-03-01",{"$nulls":5},"This study will be conducted to evaluate the efficacy, safety, and tolerability of AVP-786 compared to placebo, for the treatment of agitation in participants with dementia of the Alzheimer's type.","Eligible participants for this study must have a diagnosis of probable Alzheimer's disease (AD) and must have clinically significant, moderate/severe agitation secondary to AD.\n\nThis is a multicenter, randomized, double-blind, placebo-controlled, parallel-design study, consisting of 12 weeks of treatment.\n\nApproximately 412 participants will be enrolled at approximately 70 centers in global geographies outside of the United States.\n\nStudy medication will be administered orally twice-daily from Day 1 through Day 85. Screening will occur within approximately 4 weeks prior to randomization. Following screening procedures for assessment of inclusion and exclusion criteria, eligible participants will be randomized into the study.","A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-design Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type","17-AVP-786-305","Agitation in Patients With Dementia of the Alzheimer's Type","Alzheimer Disease|Dementia","Neurocognitive Disorders","Central Nervous System","Placebo Comparator|Experimental","Placebo|AVP-786; Dose 1|AVP-786; Dose 2","Participants will be assigned to treatment with placebo capsules administered twice a day over a 12-week period.|Participants will receive AVP-786 (Dose 1) capsules administered twice a day over a 12-week period.|Participants will receive AVP-786 (Dose 2) capsules administered twice a day over a 12-week period.","Drug","Placebo|AVP-786","oral capsules",null,"Placebo|AVP-786; Dose 1|AVP-786; Dose 2","\n\n * Diagnosis of probable Alzheimer's Disease (AD) according to the 2011 National Institute on Aging-Alzheimer's Association (NIA-AA) working groups criteria\n * Participants with clinically significant, moderate/severe agitation at the time of screening and for at least 2 weeks prior to randomization that interferes with their daily routine and for which a prescription medication has been indicated, in the opinion of the investigator\n * The diagnosis of agitation must meet the provisional consensus definition of agitation in participants with cognitive disorders developed by the International Psychogeriatric Association (IPA) Agitation Definition Work Group.\n * A Clinical Global Impression of Severity of Illness scale for Agitation (CGIS-Agitation) score of â‰¥ 4 (moderately ill) at screening and baseline\n * Participants must have a reliable caregiver who is able and willing to comply with study procedures, including not administering any prohibited medications during the course of the study.\n * Caregiver who is able and willing to comply with all required study procedures. In order to qualify as a reliable informant (i.e., caregiver) capable of assessing changes in participant's condition during the study, the individual must spend a minimum of 2 hours per day for 4 days per week with the participant.\n\n","\n\n * Participants with dementia predominantly of the non-Alzheimer's type (e.g., vascular dementia, frontotemporal dementia, Parkinson's disease, substance-induced dementia)\n * Participants with symptoms of agitation that are not secondary to AD (e.g., secondary to pain, other psychiatric disorder, or delirium)\n * Participants with co-existent clinically significant or unstable systemic diseases that could confound the interpretation of the safety results of the study (e.g., malignancy, poorly controlled diabetes, poorly controlled hypertension, unstable pulmonary, renal or hepatic disease, unstable ischemic cardiac disease, dilated cardiomyopathy, or unstable valvular heart disease)\n * Participants with myasthenia gravis",{"$nulls":4},"Actual","2018-01-08","Actual","Anticipated","2020-03-01","Anticipated","2018-04-01","2018-01-03","2018-01-03","2018-04-30","Yes","Agitation\nDementia of the Alzheimer's type\nAlzheimer's disease\nAVP-786\nDeudextromethorphan hydrobromide\nQuinidine sulfate","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","50 Years","90 Years","All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"2017-001339-38","EudraCT Number","Change from Baseline to Week 12 in the Cohen-Mansfield Agitation Inventory (CMAI) Composite Score","Baseline; Week 12",null,"Change from Baseline to Week 12 in the Modified Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change for Agitation (mADCS-CGIC-Agitation) Score|Change from Baseline to Week 12 in the Neuropsychiatric Inventory (NPI) Agitation/Aggression Domain Score|Change from Baseline to Week 12 in the NPI Caregiver Distress Score|Change from Baseline to Week 12 in the NPI Aberrant Motor Behavior Domain Score|Change from Baseline to Week 12 in the NPI Irritability/Lability Domain Score|Change from Baseline to Week 12 in the NPI Total Score|Change from Baseline to Week 12 in the Clinical Global Impression of Severity (CGIS)-Agitation Domain Score|Change from Baseline to Week 12 in the ADCS-CGIC for Overall Clinical Status Rating|Change from Baseline to Week 12 in the Patient Global Impression of Change (PGIC) Scale Score|Change from Baseline to Week 12 in the Dementia Quality of Life (DEMQOL) Scale Score|Change from Baseline to Week 12 in EuroQol-5 Dimension-5 Level (EQ-5D-5L) Dimension Scores|Change from Baseline to Week 12 in the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) Score|Change from Baseline to Week 12 in the Resource Utilization in Dementia (RUD) Scale Score","Baseline; Week 12",{"$nulls":4},"Nedlands, Australia Neuro Trials Victoria Pty LtdNoble Park, Australia|Budapest, Hungary Szabolcs-Szatmar-Bereg Megyei Korhazak Es Egyetemi OktatokorhazNyiregyhaza, Hungary PsychotechPecs, Hungary Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai KozpontSzeged, Hungary",null,"Australia|Hungary","Australian Alzheimer's Research Foundation|Semmelweis Egyetem",{"$nulls":4},"2018-04-30","2020-05-25T16:35:42.423","2020-05-26T17:10:42.972","NCT03393520"]
["5ecbf3dee2561b1b11905cde","NCT03393520","2018-05-24","Avanir","AVNR","Recruiting","Assessment of the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type","Avp-786",null,"Yes","['Avp-786']","Unknown",null,"Phase 3",3,412,"Anticipated","2017-10-13","2020-03-01",{"$nulls":5},"This study will be conducted to evaluate the efficacy, safety, and tolerability of AVP-786 compared to placebo, for the treatment of agitation in participants with dementia of the Alzheimer's type.","Eligible participants for this study must have a diagnosis of probable Alzheimer's disease (AD) and must have clinically significant, moderate/severe agitation secondary to AD.\n\nThis is a multicenter, randomized, double-blind, placebo-controlled, parallel-design study, consisting of 12 weeks of treatment.\n\nApproximately 412 participants will be enrolled at approximately 70 centers in global geographies outside of the United States.\n\nStudy medication will be administered orally twice-daily from Day 1 through Day 85. Screening will occur within approximately 4 weeks prior to randomization. Following screening procedures for assessment of inclusion and exclusion criteria, eligible participants will be randomized into the study.","A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-design Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type","17-AVP-786-305","Agitation in Patients With Dementia of the Alzheimer's Type","Alzheimer Disease|Dementia","Neurocognitive Disorders","Central Nervous System","Placebo Comparator|Experimental","Placebo|AVP-786; Dose 1|AVP-786; Dose 2","Participants will be assigned to treatment with placebo capsules administered twice a day over a 12-week period.|Participants will receive AVP-786 (Dose 1) capsules administered twice a day over a 12-week period.|Participants will receive AVP-786 (Dose 2) capsules administered twice a day over a 12-week period.","Drug","Placebo|AVP-786","oral capsules",null,"Placebo|AVP-786; Dose 1|AVP-786; Dose 2","\n\n * Diagnosis of probable Alzheimer's Disease (AD) according to the 2011 National Institute on Aging-Alzheimer's Association (NIA-AA) working groups criteria\n * Participants with clinically significant, moderate/severe agitation at the time of screening and for at least 2 weeks prior to randomization that interferes with their daily routine and for which a prescription medication has been indicated, in the opinion of the investigator\n * The diagnosis of agitation must meet the provisional consensus definition of agitation in participants with cognitive disorders developed by the International Psychogeriatric Association (IPA) Agitation Definition Work Group.\n * A Clinical Global Impression of Severity of Illness scale for Agitation (CGIS-Agitation) score of â‰¥ 4 (moderately ill) at screening and baseline\n * Participants must have a reliable caregiver who is able and willing to comply with study procedures, including not administering any prohibited medications during the course of the study.\n * Caregiver who is able and willing to comply with all required study procedures. In order to qualify as a reliable informant (i.e., caregiver) capable of assessing changes in participant's condition during the study, the individual must spend a minimum of 2 hours per day for 4 days per week with the participant.\n\n","\n\n * Participants with dementia predominantly of the non-Alzheimer's type (e.g., vascular dementia, frontotemporal dementia, Parkinson's disease, substance-induced dementia)\n * Participants with symptoms of agitation that are not secondary to AD (e.g., secondary to pain, other psychiatric disorder, or delirium)\n * Participants with co-existent clinically significant or unstable systemic diseases that could confound the interpretation of the safety results of the study (e.g., malignancy, poorly controlled diabetes, poorly controlled hypertension, unstable pulmonary, renal or hepatic disease, unstable ischemic cardiac disease, dilated cardiomyopathy, or unstable valvular heart disease)\n * Participants with myasthenia gravis",{"$nulls":4},"Actual","2018-01-08","Actual","Anticipated","2020-03-01","Anticipated","2018-05-01","2018-01-03","2018-01-03","2018-05-23","Yes","Agitation\nDementia of the Alzheimer's type\nAlzheimer's disease\nAVP-786\nDeudextromethorphan hydrobromide\nQuinidine sulfate","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","50 Years","90 Years","All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"2017-001339-38","EudraCT Number","Change from Baseline to Week 12 in the Cohen-Mansfield Agitation Inventory (CMAI) Composite Score","Baseline; Week 12",null,"Change from Baseline to Week 12 in the Modified Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change for Agitation (mADCS-CGIC-Agitation) Score|Change from Baseline to Week 12 in the Neuropsychiatric Inventory (NPI) Agitation/Aggression Domain Score|Change from Baseline to Week 12 in the NPI Caregiver Distress Score|Change from Baseline to Week 12 in the NPI Aberrant Motor Behavior Domain Score|Change from Baseline to Week 12 in the NPI Irritability/Lability Domain Score|Change from Baseline to Week 12 in the NPI Total Score|Change from Baseline to Week 12 in the Clinical Global Impression of Severity (CGIS)-Agitation Domain Score|Change from Baseline to Week 12 in the ADCS-CGIC for Overall Clinical Status Rating|Change from Baseline to Week 12 in the Patient Global Impression of Change (PGIC) Scale Score|Change from Baseline to Week 12 in the Dementia Quality of Life (DEMQOL) Scale Score|Change from Baseline to Week 12 in EuroQol-5 Dimension-5 Level (EQ-5D-5L) Dimension Scores|Change from Baseline to Week 12 in the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) Score|Change from Baseline to Week 12 in the Resource Utilization in Dementia (RUD) Scale Score","Baseline; Week 12",{"$nulls":4},"Nedlands, Australia Neuro Trials Victoria Pty LtdNoble Park, Australia|Budapest, Hungary Szent Janos Korhaz Es Eszak-Budai Egyesitett KorhazakBudapest, Hungary Debreceni Egyetem Kenezy Gyula Egyetemi KorhazDebrecen, Hungary Valeomed Egeszsegugyi Es Szolgaltato KftEsztergom, Hungary Szabolcs-Szatmar-Bereg Megyei Korhazak Es Egyetemi OktatokorhazNyiregyhaza, Hungary PsychotechPecs, Hungary Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai KozpontSzeged, Hungary",null,"Australia|Hungary","Australian Alzheimer's Research Foundation|Semmelweis Egyetem",{"$nulls":4},"2018-05-23","2020-05-25T16:35:42.459","2020-05-26T17:10:42.972","NCT03393520"]
["5ecbf3de11702c1b1b9169f5","NCT03393520","2018-10-22","Avanir","AVNR","Recruiting","Assessment of the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type","Avp-786",null,"Yes","['Avp-786']","Unknown",null,"Phase 3",3,412,"Anticipated","2017-10-13","2021-06-01",{"$nulls":5},"This study will be conducted to evaluate the efficacy, safety, and tolerability of AVP-786 compared to placebo, for the treatment of agitation in participants with dementia of the Alzheimer's type.","Eligible participants for this study must have a diagnosis of probable Alzheimer's disease (AD) and must have clinically significant, moderate/severe agitation secondary to AD.\n\nThis is a multicenter, randomized, double-blind, placebo-controlled, parallel-design study, consisting of 12 weeks of treatment.\n\nApproximately 412 participants will be enrolled at approximately 90 centers worldwide.\n\nStudy medication will be administered orally twice-daily from Day 1 through Day 85. Screening will occur within approximately 4 weeks prior to randomization. Following screening procedures for assessment of inclusion and exclusion criteria, eligible participants will be randomized into the study.","A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-design Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type","17-AVP-786-305","Agitation in Patients With Dementia of the Alzheimer's Type","Alzheimer Disease|Dementia","Neurocognitive Disorders","Central Nervous System","Placebo Comparator|Experimental","Placebo|AVP-786; Dose 1|AVP-786; Dose 2","Participants will be assigned to treatment with placebo capsules administered twice a day over a 12-week period.|Participants will receive AVP-786 (Dose 1) capsules administered twice a day over a 12-week period.|Participants will receive AVP-786 (Dose 2) capsules administered twice a day over a 12-week period.","Drug","Placebo|AVP-786","oral capsules",null,"Placebo|AVP-786; Dose 1|AVP-786; Dose 2","\n\n * Diagnosis of probable Alzheimer's Disease (AD) according to the 2011 National Institute on Aging-Alzheimer's Association (NIA-AA) working groups criteria\n * Participants with clinically significant, moderate/severe agitation at the time of screening and for at least 2 weeks prior to randomization that interferes with their daily routine and for which a prescription medication has been indicated, in the opinion of the investigator\n * The diagnosis of agitation must meet the provisional consensus definition of agitation in participants with cognitive disorders developed by the International Psychogeriatric Association (IPA) Agitation Definition Work Group.\n * A Clinical Global Impression of Severity of Illness scale for Agitation (CGIS-Agitation) score of â‰¥ 4 (moderately ill) at screening and baseline\n * Participants must have a reliable caregiver who is able and willing to comply with study procedures, including not administering any prohibited medications during the course of the study.\n * Caregiver who is able and willing to comply with all required study procedures. In order to qualify as a reliable informant (i.e., caregiver) capable of assessing changes in participant's condition during the study, the individual must spend a minimum of 2 hours per day for 4 days per week with the participant.\n\n","\n\n * Participants with dementia predominantly of the non-Alzheimer's type (e.g., vascular dementia, frontotemporal dementia, Parkinson's disease, substance-induced dementia)\n * Participants with symptoms of agitation that are not secondary to AD (e.g., secondary to pain, other psychiatric disorder, or delirium)\n * Participants with co-existent clinically significant or unstable systemic diseases that could confound the interpretation of the safety results of the study (e.g., malignancy, poorly controlled diabetes, poorly controlled hypertension, unstable pulmonary, renal or hepatic disease, unstable ischemic cardiac disease, dilated cardiomyopathy, or unstable valvular heart disease)\n * Participants with myasthenia gravis",{"$nulls":4},"Actual","2018-01-08","Actual","Anticipated","2021-06-01","Anticipated","2018-10-01","2018-01-03","2018-01-03","2018-10-18","Yes","Agitation\nDementia of the Alzheimer's type\nAlzheimer's disease\nAVP-786\nDeudextromethorphan hydrobromide\nQuinidine sulfate","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","50 Years","90 Years","All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"2017-001339-38","EudraCT Number","Change from Baseline to Week 12 in the Cohen-Mansfield Agitation Inventory (CMAI) Composite Score","Baseline; Week 12",null,"Change from Baseline to Week 12 in the Modified Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change for Agitation (mADCS-CGIC-Agitation) Score|Change from Baseline to Week 12 in the Neuropsychiatric Inventory (NPI) Agitation/Aggression Domain Score|Change from Baseline to Week 12 in the NPI Caregiver Distress Score|Change from Baseline to Week 12 in the NPI Aberrant Motor Behavior Domain Score|Change from Baseline to Week 12 in the NPI Irritability/Lability Domain Score|Change from Baseline to Week 12 in the NPI Total Score|Change from Baseline to Week 12 in the Clinical Global Impression of Severity (CGIS)-Agitation Domain Score|Change from Baseline to Week 12 in the ADCS-CGIC for Overall Clinical Status Rating|Change from Baseline to Week 12 in the Patient Global Impression of Change (PGIC) Scale Score|Change from Baseline to Week 12 in the Dementia Quality of Life (DEMQOL) Scale Score|Change from Baseline to Week 12 in EuroQol-5 Dimension-5 Level (EQ-5D-5L) Dimension Scores|Change from Baseline to Week 12 in the Resource Utilization in Dementia (RUD) Scale Score","Baseline; Week 12",{"$nulls":4},"Nedlands, Australia Neuro Trials Victoria Pty LtdNoble Park, Australia|Budapest, Hungary Szent Janos Korhaz Es Eszak-Budai Egyesitett KorhazakBudapest, Hungary Debreceni Egyetem Kenezy Gyula Egyetemi KorhazDebrecen, Hungary Valeomed Egeszsegugyi Es Szolgaltato KftEsztergom, Hungary Szabolcs-Szatmar-Bereg Megyei Korhazak Es Egyetemi OktatokorhazNyiregyhaza, Hungary PsychotechPecs, Hungary Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai KozpontSzeged, Hungary",null,"Australia|Hungary","Australian Alzheimer's Research Foundation|Semmelweis Egyetem",{"$nulls":4},"2018-10-18","2020-05-25T16:35:42.454","2020-05-26T17:10:42.972","NCT03393520"]
["5ecbf3de307e3d1b1f8d9c73","NCT03393520","2019-03-07","Avanir","AVNR","Recruiting","Assessment of the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type","Avp-786",null,"Yes","['Avp-786']","Unknown",null,"Phase 3",3,412,"Anticipated","2017-10-13","2021-06-01",{"$nulls":5},"This study will be conducted to evaluate the efficacy, safety, and tolerability of AVP-786 compared to placebo, for the treatment of agitation in participants with dementia of the Alzheimer's type.","Eligible participants for this study must have a diagnosis of probable Alzheimer's disease (AD) and must have clinically significant, moderate/severe agitation secondary to AD.\n\nThis is a multicenter, randomized, double-blind, placebo-controlled, parallel-design study, consisting of 12 weeks of treatment.\n\nApproximately 412 participants will be enrolled at approximately 90 centers worldwide.\n\nStudy medication will be administered orally twice-daily from Day 1 through Day 85. Screening will occur within approximately 4 weeks prior to randomization. Following screening procedures for assessment of inclusion and exclusion criteria, eligible participants will be randomized into the study.","A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-design Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type","17-AVP-786-305","Agitation in Patients With Dementia of the Alzheimer's Type","Alzheimer Disease|Dementia","Neurocognitive Disorders","Central Nervous System","Placebo Comparator|Experimental","Placebo|AVP-786; Dose 1|AVP-786; Dose 2","Participants will be assigned to treatment with placebo capsules administered twice a day over a 12-week period.|Participants will receive AVP-786 (Dose 1) capsules administered twice a day over a 12-week period.|Participants will receive AVP-786 (Dose 2) capsules administered twice a day over a 12-week period.","Drug","Placebo|AVP-786","oral capsules",null,"Placebo|AVP-786; Dose 1|AVP-786; Dose 2","\n\n * Diagnosis of probable Alzheimer's Disease (AD) according to the 2011 National Institute on Aging-Alzheimer's Association (NIA-AA) working groups criteria\n * Participants with clinically significant, moderate/severe agitation at the time of screening and for at least 2 weeks prior to randomization that interferes with their daily routine and for which a prescription medication has been indicated, in the opinion of the investigator\n * The diagnosis of agitation must meet the provisional consensus definition of agitation in participants with cognitive disorders developed by the International Psychogeriatric Association (IPA) Agitation Definition Work Group.\n * A Clinical Global Impression of Severity of Illness scale for Agitation (CGIS-Agitation) score of â‰¥ 4 (moderately ill) at screening and baseline\n * Participants must have a reliable caregiver who is able and willing to comply with study procedures, including not administering any prohibited medications during the course of the study.\n * Caregiver who is able and willing to comply with all required study procedures. In order to qualify as a reliable informant (i.e., caregiver) capable of assessing changes in participant's condition during the study, the individual must spend a minimum of 2 hours per day for 4 days per week with the participant.\n\n","\n\n * Participants with dementia predominantly of the non-Alzheimer's type (e.g., vascular dementia, frontotemporal dementia, Parkinson's disease, substance-induced dementia)\n * Participants with symptoms of agitation that are not secondary to AD (e.g., secondary to pain, other psychiatric disorder, or delirium)\n * Participants with co-existent clinically significant or unstable systemic diseases that could confound the interpretation of the safety results of the study (e.g., malignancy, poorly controlled diabetes, poorly controlled hypertension, unstable pulmonary, renal or hepatic disease, unstable ischemic cardiac disease, dilated cardiomyopathy, or unstable valvular heart disease)\n * Participants with myasthenia gravis",{"$nulls":4},"Actual","2018-01-08","Actual","Anticipated","2021-06-01","Anticipated","2019-03-01","2018-01-03","2018-01-03","2019-03-05","Yes","Agitation\nDementia of the Alzheimer's type\nAlzheimer's disease\nAVP-786\nDeudextromethorphan hydrobromide\nQuinidine sulfate","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","50 Years","90 Years","All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"2017-001339-38","EudraCT Number","Change from Baseline to Week 12 in the Cohen-Mansfield Agitation Inventory (CMAI) Composite Score","Baseline; Week 12",null,"Change from Baseline to Week 12 in the Modified Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change for Agitation (mADCS-CGIC-Agitation) Score|Change from Baseline to Week 12 in the Neuropsychiatric Inventory (NPI) Agitation/Aggression Domain Score|Change from Baseline to Week 12 in the NPI Caregiver Distress Score|Change from Baseline to Week 12 in the NPI Aberrant Motor Behavior Domain Score|Change from Baseline to Week 12 in the NPI Irritability/Lability Domain Score|Change from Baseline to Week 12 in the NPI Total Score|Change from Baseline to Week 12 in the Clinical Global Impression of Severity (CGIS)-Agitation Domain Score|Change from Baseline to Week 12 in the ADCS-CGIC for Overall Clinical Status Rating|Change from Baseline to Week 12 in the Patient Global Impression of Change (PGIC) Scale Score|Change from Baseline to Week 12 in the Dementia Quality of Life (DEMQOL) Scale Score|Change from Baseline to Week 12 in EuroQol-5 Dimension-5 Level (EQ-5D-5L) Dimension Scores|Change from Baseline to Week 12 in the Resource Utilization in Dementia (RUD) Scale Score","Baseline; Week 12",{"$nulls":4},"Nedlands, Australia Neuro Trials Victoria Pty LtdNoble Park, Australia|Ruse, Bulgaria Medical Center Sveti NaumSofia, Bulgaria Medica Plus Medical CenterVeliko Tarnovo, Bulgaria|Budapest, Hungary Szent Janos Korhaz Es Eszak-Budai Egyesitett Korhazak[Active, Not Recruiting]Budapest, Hungary Debreceni Egyetem Kenezy Gyula Egyetemi KorhazDebrecen, Hungary Valeomed Egeszsegugyi Es Szolgaltato KftEsztergom, Hungary Szabolcs-Szatmar-Bereg Megyei Korhazak Es Egyetemi Oktatokorhaz[Active, Not Recruiting]Nyiregyhaza, Hungary PsychotechPecs, Hungary Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont[Active, Not Recruiting]Szeged, Hungary|Brescia, Italy Fondazione Santa Lucia - Istituto Di Ricovero E Cura A Carattere ScientificoRoma, Italy|Szczecin, Poland|Cape Town, South Africa|Barcelona, Spain FundaciÃ³ Hospital De La Santa Creu I Sant PauBarcelona, Spain Hospital Clinic De BarcelonaBarcelona, Spain Hospital Universitario Reina SofiaCÃ³rdoba, Spain Hospital Universitario Virgen MacarenaSevilla, Spain Hospital Viamed MontecanalZaragoza, Spain|Barnsley, United Kingdom Research Institute For The Care Of Older PeopleBath, United Kingdom Mac Clinical Research - BlackpoolBlackpool, United Kingdom Mac Clinical Research - CannockCannock, United Kingdom Mac Clinical Research - LeedsLeeds, United Kingdom Re-Cognition Health - LondonLondon, United Kingdom South London And Maudsley Nhs Foundation TrustLondon, United Kingdom Mac Clinical Research - ManchesterManchester, United Kingdom Southern Health Nhs Foundation TrustSouthampton, United Kingdom Avon And Wiltshire Mental Health Partnership Nhs TrustSwindon, United Kingdom|Caro, Michigan, United States, 48723|Chesterfield, Missouri, United States, 63005","Michigan|Missouri","Australia|Bulgaria|Hungary|Italy|Poland|South Africa|Spain|United Kingdom|United States","Australian Alzheimer's Research Foundation|Center For Mental Health - Ruse|Semmelweis Egyetem|Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia|Centrum Medyczne Euromedis|Cape Trial Centre|FundaciÃ³ Ace|Mac Clinical Research - Barnsley|Onyx Clinical Research, Llc|Galen Research",{"$nulls":4},"2019-03-05","2020-05-25T16:35:42.575","2020-05-26T17:10:42.972","NCT03393520"]
["5ecbf3defeab101b15530813","NCT03393520","2019-07-17","Avanir","AVNR","Recruiting","Assessment of the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type","Avp-786",null,"Yes","['Avp-786']","Unknown",null,"Phase 3",3,412,"Anticipated","2017-10-13","2021-06-01",{"$nulls":5},"This study will be conducted to evaluate the efficacy, safety, and tolerability of AVP-786 compared to placebo, for the treatment of agitation in participants with dementia of the Alzheimer's type.","Eligible participants for this study must have a diagnosis of probable Alzheimer's disease (AD) and must have clinically significant, moderate/severe agitation secondary to AD.\n\nThis is a multicenter, randomized, double-blind, placebo-controlled, parallel-design study, consisting of 12 weeks of treatment.\n\nApproximately 412 participants will be enrolled at approximately 90 centers worldwide.\n\nStudy medication will be administered orally twice-daily from Day 1 through Day 85. Screening will occur within approximately 4 weeks prior to randomization. Following screening procedures for assessment of inclusion and exclusion criteria, eligible participants will be randomized into the study.","A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-design Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type","17-AVP-786-305","Agitation in Patients With Dementia of the Alzheimer's Type","Alzheimer Disease|Dementia","Neurocognitive Disorders","Central Nervous System","Placebo Comparator|Experimental","Placebo|AVP-786; Dose 1|AVP-786; Dose 2","Participants will be assigned to treatment with placebo capsules administered twice a day over a 12-week period.|Participants will receive AVP-786 (Dose 1) capsules administered twice a day over a 12-week period.|Participants will receive AVP-786 (Dose 2) capsules administered twice a day over a 12-week period.","Drug","Placebo|AVP-786","oral capsules",null,"Placebo|AVP-786; Dose 1|AVP-786; Dose 2","\n\n * Diagnosis of probable Alzheimer's Disease (AD) according to the 2011 National Institute on Aging-Alzheimer's Association (NIA-AA) working groups criteria\n * Participants with clinically significant, moderate/severe agitation at the time of screening and for at least 2 weeks prior to randomization that interferes with their daily routine and for which a prescription medication has been indicated, in the opinion of the investigator\n * The diagnosis of agitation must meet the provisional consensus definition of agitation in participants with cognitive disorders developed by the International Psychogeriatric Association (IPA) Agitation Definition Work Group.\n * A Clinical Global Impression of Severity of Illness scale for Agitation (CGIS-Agitation) score of â‰¥ 4 (moderately ill) at screening and baseline\n * Participants must have a reliable caregiver who is able and willing to comply with study procedures, including not administering any prohibited medications during the course of the study.\n * Caregiver who is able and willing to comply with all required study procedures. In order to qualify as a reliable informant (i.e., caregiver) capable of assessing changes in participant's condition during the study, the individual must spend a minimum of 2 hours per day for 4 days per week with the participant.\n\n","\n\n * Participants with dementia predominantly of the non-Alzheimer's type (e.g., vascular dementia, frontotemporal dementia, Parkinson's disease, substance-induced dementia)\n * Participants with symptoms of agitation that are not secondary to AD (e.g., secondary to pain, other psychiatric disorder, or delirium)\n * Participants with co-existent clinically significant or unstable systemic diseases that could confound the interpretation of the safety results of the study (e.g., malignancy, poorly controlled diabetes, poorly controlled hypertension, unstable pulmonary, renal or hepatic disease, unstable ischemic cardiac disease, dilated cardiomyopathy, or unstable valvular heart disease)\n * Participants with myasthenia gravis",{"$nulls":4},"Actual","2018-01-08","Actual","Anticipated","2021-06-01","Anticipated","2019-07-01","2018-01-03","2018-01-03","2019-07-15","Yes","Agitation\nDementia of the Alzheimer's type\nAlzheimer's disease\nAVP-786\nDeudextromethorphan hydrobromide\nQuinidine sulfate","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","50 Years","90 Years","All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"2017-001339-38","EudraCT Number","Change from Baseline to Week 12 in the Cohen-Mansfield Agitation Inventory (CMAI) Composite Score","Baseline; Week 12",null,"Change from Baseline to Week 12 in the Modified Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change for Agitation (mADCS-CGIC-Agitation) Score|Change from Baseline to Week 12 in the Neuropsychiatric Inventory (NPI) Agitation/Aggression Domain Score|Change from Baseline to Week 12 in the NPI Caregiver Distress Score|Change from Baseline to Week 12 in the NPI Aberrant Motor Behavior Domain Score|Change from Baseline to Week 12 in the NPI Irritability/Lability Domain Score|Change from Baseline to Week 12 in the NPI Total Score|Change from Baseline to Week 12 in the Clinical Global Impression of Severity (CGIS)-Agitation Domain Score|Change from Baseline to Week 12 in the ADCS-CGIC for Overall Clinical Status Rating|Change from Baseline to Week 12 in the Patient Global Impression of Change (PGIC) Scale Score|Change from Baseline to Week 12 in the Dementia Quality of Life (DEMQOL) Scale Score|Change from Baseline to Week 12 in EuroQol-5 Dimension-5 Level (EQ-5D-5L) Dimension Scores|Change from Baseline to Week 12 in the Resource Utilization in Dementia (RUD) Scale Score","Baseline; Week 12",{"$nulls":4},"Nedlands, Western|Noble Park, Victoria, Australia, 3174|Ruse, Bulgaria, 7003 Medica Plus Medical CenterVeliko Tarnovo, Bulgaria, 5000|Sofia, Sofiya, Bulgaria, 1113|Budapest, Hungary, 1083 Szent Janos Korhaz Es Eszak-Budai Egyesitett Korhazak[Active, Not Recruiting]Budapest, Hungary, 1125 Debreceni Egyetem Kenezy Gyula Egyetemi KorhazDebrecen, Hungary, 4031 Valeomed Egeszsegugyi Es Szolgaltato Kft[Active, Not Recruiting]Esztergom, Hungary, 2500 Szabolcs-Szatmar-Bereg Megyei Korhazak Es Egyetemi Oktatokorhaz[Active, Not Recruiting]Nyiregyhaza, Hungary, 4400 PsychotechPecs, Hungary, 7633 Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont[Active, Not Recruiting]Szeged, Hungary, 6725|Roma, Italy, 179|Brescia, Roma, Italy, 25123|Szczecin, Zachodniopomorskie, Poland, 70-111|Cape Town, Western Cape, South Africa, 7530|Barcelona, Spain, 8028 Hospital Clinic De BarcelonaBarcelona, Spain, 8036 FundaciÃ³ Hospital De La Santa Creu I Sant PauBarcelona, Spain, 8041 Hospital Universitario Reina SofiaCÃ³rdoba, Spain, 14011 Hospital Universitario Virgen MacarenaSevilla, Spain, 41009 Hospital Viamed MontecanalZaragoza, Spain, 50012|Barnsley, England, United Kingdom, S75 3Dl Research Institute For The Care Of Older PeopleBath, England, United Kingdom, Ba1 3Ng Mac Clinical Research - BlackpoolBlackpool, England, United Kingdom, Fy2 0Jh Mac Clinical Research - CannockCannock, England, United Kingdom, Ws11 0Bn Mac Clinical Research - LeedsLeeds, England, United Kingdom, Ls10 1Du South London And Maudsley Nhs Foundation TrustLondon, England, United Kingdom, Se5 8Af Re:Cognition Health - LondonLondon, England, United Kingdom, W1G 9Jf Mac Clinical Research - ManchesterManchester, England, United Kingdom, M13 9Nq Southern Health Nhs Foundation TrustSouthampton, England, United Kingdom, So30 3Jb Avon And Wiltshire Mental Health Partnership Nhs TrustSwindon, England, United Kingdom, Sn3 6Bw|Little Rock, Arkansas, United States, 72205|[Active, Not Recruiting]Boca Raton, Florida, United States, 33487 Helix Biomedics LlcBoynton Beach, Florida, United States, 33436 Zynak Clinical ServicesLauderdale Lakes, Florida, United States, 33313 Crystal Biomedical Research, Llc[Active, Not Recruiting]Miami Lakes, Florida, United States, 33014 City Medical Group Rc[Active, Not Recruiting]Miami, Florida, United States, 33126 Finlay Medical Research CorpMiami, Florida, United States, 33126 Research Institute Of West Kendall[Active, Not Recruiting]Miami, Florida, United States, 33186 Bayside Clinical Research[Active, Not Recruiting]New Port Richey, Florida, United States, 34655|Caro, Michigan, United States, 48723|Chesterfield, Missouri, United States, 63005|[Active, Not Recruiting]Oklahoma City, Oklahoma, United States, 73102","Arkansas|Florida|Michigan|Missouri|Oklahoma","Australia|Bulgaria|Hungary|Italy|Poland|South Africa|Spain|United Kingdom|United States","Australian Alzheimer's Research Foundation|Victoria Neuro Trials Victoria Pty Ltd|Center For Mental Health - Ruse|Sofiya Medical Center Sveti Naum|Semmelweis Egyetem|Fondazione Santa Lucia - Istituto Di Ricovero E Cura A Carattere Scientifico|Roma Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia|Zachodniopomorskie Centrum Medyczne Euromedis|, Western Cape Cape Trial Centre|FundaciÃ³ Ace|, England Mac Clinical Research - Barnsley|Clinical Trials Inc.|Sfm Clinical Research, Llc|Onyx Clinical Research, Llc|Galen Research|Newton Clinical Research",{"$nulls":4},"2019-07-15","2020-05-25T16:35:42.965","2020-05-26T17:10:42.972","NCT03393520"]
["5ecbf3df307e3d1b1f8d9c74","NCT03393520","2019-09-09","Avanir","AVNR","Recruiting","Assessment of the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type","Avp-786",null,"Yes","['Avp-786']","Unknown",null,"Phase 3",3,412,"Anticipated","2017-10-13","2021-06-01",{"$nulls":5},"This study will be conducted to evaluate the efficacy, safety, and tolerability of AVP-786 compared to placebo, for the treatment of agitation in participants with dementia of the Alzheimer's type.","Eligible participants for this study must have a diagnosis of probable Alzheimer's disease (AD) and must have clinically significant, moderate/severe agitation secondary to AD.\n\nThis is a multicenter, randomized, double-blind, placebo-controlled, parallel-design study, consisting of 12 weeks of treatment.\n\nApproximately 412 participants will be enrolled at approximately 90 centers worldwide.\n\nStudy medication will be administered orally twice-daily from Day 1 through Day 85. Screening will occur within approximately 4 weeks prior to randomization. Following screening procedures for assessment of inclusion and exclusion criteria, eligible participants will be randomized into the study.","A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-design Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type","17-AVP-786-305","Agitation in Patients With Dementia of the Alzheimer's Type","Alzheimer Disease|Dementia","Neurocognitive Disorders","Central Nervous System","Placebo Comparator|Experimental","Placebo|AVP-786; Dose 1|AVP-786; Dose 2","Participants will be assigned to treatment with placebo capsules administered twice a day over a 12-week period.|Participants will receive AVP-786 (Dose 1) capsules administered twice a day over a 12-week period.|Participants will receive AVP-786 (Dose 2) capsules administered twice a day over a 12-week period.","Drug","Placebo|AVP-786","oral capsules",null,"Placebo|AVP-786; Dose 1|AVP-786; Dose 2","\n\n * Diagnosis of probable Alzheimer's Disease (AD) according to the 2011 National Institute on Aging-Alzheimer's Association (NIA-AA) working groups criteria\n * Participants with clinically significant, moderate/severe agitation at the time of screening and for at least 2 weeks prior to randomization that interferes with their daily routine and for which a prescription medication has been indicated, in the opinion of the investigator\n * The diagnosis of agitation must meet the provisional consensus definition of agitation in participants with cognitive disorders developed by the International Psychogeriatric Association (IPA) Agitation Definition Work Group.\n * A Clinical Global Impression of Severity of Illness scale for Agitation (CGIS-Agitation) score of â‰¥ 4 (moderately ill) at screening and baseline\n * Participants must have a reliable caregiver who is able and willing to comply with study procedures, including not administering any prohibited medications during the course of the study.\n * Caregiver who is able and willing to comply with all required study procedures. In order to qualify as a reliable informant (i.e., caregiver) capable of assessing changes in participant's condition during the study, the individual must spend a minimum of 2 hours per day for 4 days per week with the participant.\n\n","\n\n * Participants with dementia predominantly of the non-Alzheimer's type (e.g., vascular dementia, frontotemporal dementia, Parkinson's disease, substance-induced dementia)\n * Participants with symptoms of agitation that are not secondary to AD (e.g., secondary to pain, other psychiatric disorder, or delirium)\n * Participants with co-existent clinically significant or unstable systemic diseases that could confound the interpretation of the safety results of the study (e.g., malignancy, poorly controlled diabetes, poorly controlled hypertension, unstable pulmonary, renal or hepatic disease, unstable ischemic cardiac disease, dilated cardiomyopathy, or unstable valvular heart disease)\n * Participants with myasthenia gravis",{"$nulls":4},"Actual","2018-01-08","Actual","Anticipated","2021-06-01","Anticipated","2019-09-01","2018-01-03","2018-01-03","2019-09-06","Yes","Agitation\nDementia of the Alzheimer's type\nAlzheimer's disease\nAVP-786\nDeudextromethorphan hydrobromide\nQuinidine sulfate","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","50 Years","90 Years","All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"2017-001339-38","EudraCT Number","Change from Baseline to Week 12 in the Cohen-Mansfield Agitation Inventory (CMAI) Composite Score","Baseline; Week 12",null,"Change from Baseline to Week 12 in the Modified Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change for Agitation (mADCS-CGIC-Agitation) Score|Change from Baseline to Week 12 in the Neuropsychiatric Inventory (NPI) Agitation/Aggression Domain Score|Change from Baseline to Week 12 in the NPI Caregiver Distress Score|Change from Baseline to Week 12 in the NPI Aberrant Motor Behavior Domain Score|Change from Baseline to Week 12 in the NPI Irritability/Lability Domain Score|Change from Baseline to Week 12 in the NPI Total Score|Change from Baseline to Week 12 in the Clinical Global Impression of Severity (CGIS)-Agitation Domain Score|Change from Baseline to Week 12 in the ADCS-CGIC for Overall Clinical Status Rating|Change from Baseline to Week 12 in the Patient Global Impression of Change (PGIC) Scale Score|Change from Baseline to Week 12 in the Dementia Quality of Life (DEMQOL) Scale Score|Change from Baseline to Week 12 in EuroQol-5 Dimension-5 Level (EQ-5D-5L) Dimension Scores|Change from Baseline to Week 12 in the Resource Utilization in Dementia (RUD) Scale Score","Baseline; Week 12",{"$nulls":4},"Nedlands, Western|Parkville, Australia|Noble Park, Victoria, Australia, 3174|Sofia, Sofiya, Bulgaria, 1113|Pleven, Bulgaria Center For Mental Health - RuseRuse, Bulgaria, 7003 First Multiprofile Hospital For Active Treatment SofiaSofia, Bulgaria Medical Center StimulSofia, Bulgaria University Multiprofile Hospital For Active Treatment AlexandrovskaSofia, Bulgaria Medica Plus Medical CenterVeliko Tarnovo, Bulgaria, 5000|Brno, Czechia FakultnÃ­ Nemocnice Hradec KrÃ¡lovÃ©Hradec KralovÃ©, Czechia Brain-SoultherapyKladno, Czechia SupervizeKutnÃ¡ Hora, Czechia Ad71Praha, Czechia ClintrialPraha, Czechia Neurologicka Ambulance - ForbeliPraha, Czechia NeuropsychiatriePraha, Czechia Vestra ClinicsRychnov Nad KnÄ›Å¾nou, Czechia|Caen Cedex 9, France Centre Hospitalier De CalaisCalais, France Centre Hospitalier Universitaire Dijon BourgognDijon Cedex, France Centre Hospitalier Universitaire De PoitiersPoitiers, France Centre Hospitalier Universitaire De Saint-Ã‰tienne - HÃ´pital NordSaint-Etienne, France Centre Hospitalier Universitaire Toulouse - Casselardit AncelyToulouse, France Centre Hospitalier Universitaire De Nancy - HÃ´pital De BraboisVandoeuvre Les Nancy, France|Balassagyarmat, Hungary Semmelweis EgyetemBudapest, Hungary, 1083 Szent Janos Korhaz Es Eszak-Budai Egyesitett KorhazakBudapest, Hungary, 1125 Debreceni Egyetem Kenezy Gyula Egyetemi KorhazDebrecen, Hungary, 4031 Valeomed Egeszsegugyi Es Szolgaltato KftEsztergom, Hungary, 2500 Cru|Miskolc, Hungary Szabolcs-Szatmar-Bereg Megyei Korhazak Es Egyetemi OktatokorhazNyiregyhaza, Hungary, 4400 PsychotechPecs, Hungary, 7633 Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai KozpontSzeged, Hungary, 6725 FejÃ©r Megyei Szent GyÃ¶rgy Egyetemi OktatÃ³ KÃ³rhÃ¡zSzÃ©kesfehÃ©rvÃ¡r, Hungary|Brescia, Italy UniversitÃ  Degli Studi G.D'Annunzio Chieti PescaraChieti, Italy Fondazione Irccs Ca' Granda Ospedale Maggiore PoliclinicoMilano, Italy Azienda Ospedaliera San Gerardo Di MonzaMonza, Italy Fondazione Santa Lucia - Istituto Di Ricovero E Cura A Carattere ScientificoRoma, Italy, 179 Azienda Ospedaliera Sant'AndreaRoma, Italy|Brescia, Roma, Italy, 25123|Szczecin, Zachodniopomorskie, Poland, 70-111|Bydgoszcz, Poland Centrum Medyczne SensemedChorzÃ³w, Poland Care ClinicKatowice, Poland Wielospecjalistyczna Poradnia Lekarska SynapsisKatowice, Poland Krakowska Akademia NeurologiiKrakÃ³w, Poland Pratia Mcm KrakÃ³wKrakÃ³w, Poland Medycyna MilorzabLodz, Poland Neurologiczny Niepubliczny ZakÅ‚ad Opieki ZdrowotnejPlewiska, Poland Centrum Medyczne HcpPoznaÅ„, Poland Solumed Centrum MedycznePoznaÅ„, Poland Centrum Medyczne NeuroprotectWarszawa, Poland Centrum Medyczne Pratia WarszawaWarszawa, Poland|Cape Town, Western Cape, South Africa, 7530|Cape Town, South Africa Flexivest Fourteen Research CentreCape Town, South Africa Apollo Clinical ResearchJohannesburg, South Africa Medical And Dental CentreRosebank, South Africa Dr. Chisto Carel CoetzeeUmhlanga, South Africa|Barcelona, Spain, 8028 Hospital Clinic De BarcelonaBarcelona, Spain, 8036 FundaciÃ³ Hospital De La Santa Creu I Sant PauBarcelona, Spain, 8041 Hospital Universitari Vall D'HebrÃ³nBarcelona, Spain Hospital Universitario Reina SofiaCÃ³rdoba, Spain, 14011 Hospital General Universitario De ElcheElche, Spain Hospital Universitari De Santa MariaLleida, Spain Hospital General Universitario Gregorio MaraÃ±Ã³nMadrid, Spain Hospital Universitario 12 De OctubreMadrid, Spain Hospital Universitario La PazMadrid, Spain ClÃ­nica Universidad De NavarraPamplona, Spain Hospital Universitario De SalamancaSalamanca, Spain Hospital Universitario MarquÃ©s De ValdecillaSantander, Spain Hospital Universitario Virgen MacarenaSevilla, Spain, 41009 Hospital Universitario Y PolitÃ©cnico De La FeValencia, Spain Complejo Asistencial De Zamora Hospital Virgen De La ConchaZamora, Spain Hospital Viamed MontecanalZaragoza, Spain, 50012|Barnsley, England, United Kingdom, S75 3Dl Research Institute For The Care Of Older PeopleBath, England, United Kingdom, Ba1 3Ng Mac Clinical Research - BlackpoolBlackpool, England, United Kingdom, Fy2 0Jh Mac Clinical Research - CannockCannock, England, United Kingdom, Ws11 0Bn Mac Clinical Research - LeedsLeeds, England, United Kingdom, Ls10 1Du South London And Maudsley Nhs Foundation TrustLondon, England, United Kingdom, Se5 8Af Re:Cognition Health - LondonLondon, England, United Kingdom, W1G 9Jf Mac Clinical Research - ManchesterManchester, England, United Kingdom, M13 9Nq Southern Health Nhs Foundation TrustSouthampton, England, United Kingdom, So30 3Jb Avon And Wiltshire Mental Health Partnership Nhs TrustSwindon, England, United Kingdom, Sn3 6Bw|Belfast, United Kingdom Northamptonshire Healthcare Nhs Foundation TrustNorthampton, United Kingdom Mac Clinical Research - LiverpoolPrescot, United Kingdom North West Boroughs Healthcare Nhs Foundation TrustWarrington, United Kingdom|Little Rock, Arkansas, United States, 72205|Boca Raton, Florida, United States, 33487 Helix Biomedics LlcBoynton Beach, Florida, United States, 33436 Alzheimer'S Research And Treatment CenterLake Worth, Florida, United States, 33449 Meridien Research - Lakeland SiteLakeland, Florida, United States, 33805 Zynak Clinical Services[Active, Not Recruiting]Lauderdale Lakes, Florida, United States, 33313 Crystal Biomedical Research, LlcMiami Lakes, Florida, United States, 33014 City Medical Group RcMiami, Florida, United States, 33126 Finlay Medical Research CorpMiami, Florida, United States, 33126 Clinical Research Associates Of South FloridaMiami, Florida, United States, 33172 Research Institute Of West KendallMiami, Florida, United States, 33186 Bayside Clinical ResearchNew Port Richey, Florida, United States, 34655|Caro, Michigan, United States, 48723|Chesterfield, Missouri, United States, 63005|Oklahoma City, Oklahoma, United States, 73102","Arkansas|Florida|Michigan|Missouri|Oklahoma","Australia|Bulgaria|Czechia|France|Hungary|Italy|Poland|South Africa|Spain|United Kingdom|United States","Australian Alzheimer's Research Foundation|The Alfred Hospital|Victoria Neuro Trials Victoria Pty Ltd|Sofiya Medical Center Sveti Naum|University Multiprofile Hospital For Active Treatment Dr. Georgi Stranski|Fakultni Nemocnice U Sv. Anny V Brne|Centre Hospitalier Universitaire De Caen - HÃ´pital CÃ´te De Nacre|Dr. Kenessey Albert KÃ³rhÃ¡z-RendelÅ‘intÃ©zet|EgÃ©szsÃ©gÃ¼gyi Ã‰s SzolgÃ¡ltatÃ³ KorlÃ¡tolt FelelÅ‘ssÃ©gÅ± TÃ¡rsasÃ¡g|Centro San Giovanni Di Dio - Fatebenefratelli|Roma Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia|Zachodniopomorskie Centrum Medyczne Euromedis|ÅšrÃ³dmieÅ›cie Przychodnia - Bydgoszcz|, Western Cape Cape Trial Centre|Acf Neurological Services|FundaciÃ³ Ace|, England Mac Clinical Research - Barnsley|Belfast Health And Social Care Trust|Clinical Trials Inc.|Sfm Clinical Research, Llc|Onyx Clinical Research, Llc|Galen Research|Newton Clinical Research",{"$nulls":4},"2019-09-06","2020-05-25T16:35:43.001","2020-05-26T17:10:42.972","NCT03393520"]
["5ecbf3e0e2561b1b11905cdf","NCT03393520","2019-10-11","Avanir","AVNR","Recruiting","Assessment of the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type","Avp-786",null,"Yes","['Avp-786']","Unknown",null,"Phase 3",3,412,"Anticipated","2017-10-13","2021-06-01",{"$nulls":5},"This study will be conducted to evaluate the efficacy, safety, and tolerability of AVP-786 compared to placebo, for the treatment of agitation in participants with dementia of the Alzheimer's type.","Eligible participants for this study must have a diagnosis of probable Alzheimer's disease (AD) and must have clinically significant, moderate/severe agitation secondary to AD.\n\nThis is a multicenter, randomized, double-blind, placebo-controlled, parallel-design study, consisting of 12 weeks of treatment.\n\nApproximately 412 participants will be enrolled at approximately 90 centers worldwide.\n\nStudy medication will be administered orally twice-daily from Day 1 through Day 85. Screening will occur within approximately 4 weeks prior to randomization. Following screening procedures for assessment of inclusion and exclusion criteria, eligible participants will be randomized into the study.","A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-design Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type","17-AVP-786-305","Agitation in Patients With Dementia of the Alzheimer's Type","Alzheimer Disease|Dementia","Neurocognitive Disorders","Central Nervous System","Placebo Comparator|Experimental","Placebo|AVP-786; Dose 1|AVP-786; Dose 2","Participants will be assigned to treatment with placebo capsules administered twice a day over a 12-week period.|Participants will receive AVP-786 (Dose 1) capsules administered twice a day over a 12-week period.|Participants will receive AVP-786 (Dose 2) capsules administered twice a day over a 12-week period.","Drug","Placebo|AVP-786","oral capsules",null,"Placebo|AVP-786; Dose 1|AVP-786; Dose 2","\n\n * Diagnosis of probable Alzheimer's Disease (AD) according to the 2011 National Institute on Aging-Alzheimer's Association (NIA-AA) working groups criteria\n * Participants with clinically significant, moderate/severe agitation at the time of screening and for at least 2 weeks prior to randomization that interferes with their daily routine and for which a prescription medication has been indicated, in the opinion of the investigator\n * The diagnosis of agitation must meet the provisional consensus definition of agitation in participants with cognitive disorders developed by the International Psychogeriatric Association (IPA) Agitation Definition Work Group.\n * A Clinical Global Impression of Severity of Illness scale for Agitation (CGIS-Agitation) score of â‰¥ 4 (moderately ill) at screening and baseline\n * Participants must have a reliable caregiver who is able and willing to comply with study procedures, including not administering any prohibited medications during the course of the study.\n * Caregiver who is able and willing to comply with all required study procedures. In order to qualify as a reliable informant (i.e., caregiver) capable of assessing changes in participant's condition during the study, the individual must spend a minimum of 2 hours per day for 4 days per week with the participant.\n\n","\n\n * Participants with dementia predominantly of the non-Alzheimer's type (e.g., vascular dementia, frontotemporal dementia, Parkinson's disease, substance-induced dementia)\n * Participants with symptoms of agitation that are not secondary to AD (e.g., secondary to pain, other psychiatric disorder, or delirium)\n * Participants with co-existent clinically significant or unstable systemic diseases that could confound the interpretation of the safety results of the study (e.g., malignancy, poorly controlled diabetes, poorly controlled hypertension, unstable pulmonary, renal or hepatic disease, unstable ischemic cardiac disease, dilated cardiomyopathy, or unstable valvular heart disease)\n * Participants with myasthenia gravis",{"$nulls":4},"Actual","2018-01-08","Actual","Anticipated","2021-06-01","Anticipated","2019-10-01","2018-01-03","2018-01-03","2019-10-09","Yes","Agitation\nDementia of the Alzheimer's type\nAlzheimer's disease\nAVP-786\nDeudextromethorphan hydrobromide\nQuinidine sulfate","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","50 Years","90 Years","All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"2017-001339-38","EudraCT Number","Change from Baseline to Week 12 in the Cohen-Mansfield Agitation Inventory (CMAI) Composite Score","Baseline; Week 12",null,"Change from Baseline to Week 12 in the Modified Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change for Agitation (mADCS-CGIC-Agitation) Score|Change from Baseline to Week 12 in the Neuropsychiatric Inventory (NPI) Agitation/Aggression Domain Score|Change from Baseline to Week 12 in the NPI Caregiver Distress Score|Change from Baseline to Week 12 in the NPI Aberrant Motor Behavior Domain Score|Change from Baseline to Week 12 in the NPI Irritability/Lability Domain Score|Change from Baseline to Week 12 in the NPI Total Score|Change from Baseline to Week 12 in the Clinical Global Impression of Severity (CGIS)-Agitation Domain Score|Change from Baseline to Week 12 in the ADCS-CGIC for Overall Clinical Status Rating|Change from Baseline to Week 12 in the Patient Global Impression of Change (PGIC) Scale Score|Change from Baseline to Week 12 in the Dementia Quality of Life (DEMQOL) Scale Score|Change from Baseline to Week 12 in EuroQol-5 Dimension-5 Level (EQ-5D-5L) Dimension Scores|Change from Baseline to Week 12 in the Resource Utilization in Dementia (RUD) Scale Score","Baseline; Week 12",{"$nulls":4},"Nedlands, Australia Neuro Trials Victoria Pty LtdNoble Park, Australia The Alfred HospitalParkville, Australia|Pleven, Bulgaria Center For Mental Health - RuseRuse, Bulgaria First Multiprofile Hospital For Active Treatment SofiaSofia, Bulgaria Medical Center StimulSofia, Bulgaria Medical Center Sveti NaumSofia, Bulgaria University Multiprofile Hospital For Active Treatment AlexandrovskaSofia, Bulgaria Medica Plus Medical CenterVeliko Tarnovo, Bulgaria|Brno, Czechia FakultnÃ­ Nemocnice Hradec KrÃ¡lovÃ©Hradec KralovÃ©, Czechia Brain-SoultherapyKladno, Czechia SupervizeKutnÃ¡ Hora, Czechia Ad71Praha, Czechia ClintrialPraha, Czechia Neurologicka Ambulance - ForbeliPraha, Czechia NeuropsychiatriePraha, Czechia Vestra ClinicsRychnov Nad KnÄ›Å¾nou, Czechia|Caen Cedex 9, France Centre Hospitalier De CalaisCalais, France Centre Hospitalier Universitaire Dijon BourgognDijon Cedex, France Centre Hospitalier Universitaire De PoitiersPoitiers, France Centre Hospitalier Universitaire De Saint-Ã‰tienne - HÃ´pital NordSaint-Etienne, France Centre Hospitalier Universitaire Toulouse - Casselardit AncelyToulouse, France Centre Hospitalier Universitaire De Nancy - HÃ´pital De BraboisVandoeuvre Les Nancy, France|Balassagyarmat, Hungary Semmelweis EgyetemBudapest, Hungary Szent Janos Korhaz Es Eszak-Budai Egyesitett KorhazakBudapest, Hungary Debreceni Egyetem Kenezy Gyula Egyetemi KorhazDebrecen, Hungary Valeomed Egeszsegugyi Es Szolgaltato KftEsztergom, Hungary Cru|Miskolc, Hungary Szabolcs-Szatmar-Bereg Megyei Korhazak Es Egyetemi OktatokorhazNyiregyhaza, Hungary PsychotechPecs, Hungary Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai KozpontSzeged, Hungary FejÃ©r Megyei Szent GyÃ¶rgy Egyetemi OktatÃ³ KÃ³rhÃ¡zSzÃ©kesfehÃ©rvÃ¡r, Hungary|Brescia, Italy Centro San Giovanni Di Dio - FatebenefratelliBrescia, Italy UniversitÃ  Degli Studi G.D'Annunzio Chieti PescaraChieti, Italy Fondazione Irccs Ca' Granda Ospedale Maggiore PoliclinicoMilano, Italy Azienda Ospedaliera San Gerardo Di MonzaMonza, Italy Azienda Ospedaliera Sant'AndreaRoma, Italy Fondazione Santa Lucia - Istituto Di Ricovero E Cura A Carattere ScientificoRoma, Italy|Bydgoszcz, Poland Centrum Medyczne SensemedChorzÃ³w, Poland Care ClinicKatowice, Poland Wielospecjalistyczna Poradnia Lekarska SynapsisKatowice, Poland Krakowska Akademia NeurologiiKrakÃ³w, Poland Pratia Mcm KrakÃ³wKrakÃ³w, Poland Medycyna MilorzabLodz, Poland Neurologiczny Niepubliczny ZakÅ‚ad Opieki ZdrowotnejPlewiska, Poland Centrum Medyczne HcpPoznaÅ„, Poland Solumed Centrum MedycznePoznaÅ„, Poland Centrum Medyczne EuromedisSzczecin, Poland Centrum Medyczne NeuroprotectWarszawa, Poland Centrum Medyczne Pratia WarszawaWarszawa, Poland|Cape Town, South Africa Cape Trial CentreCape Town, South Africa Flexivest Fourteen Research CentreCape Town, South Africa Apollo Clinical ResearchJohannesburg, South Africa Medical And Dental CentreRosebank, South Africa Dr. Chisto Carel CoetzeeUmhlanga, South Africa|Barcelona, Spain FundaciÃ³ Hospital De La Santa Creu I Sant PauBarcelona, Spain Hospital Clinic De BarcelonaBarcelona, Spain Hospital Universitari Vall D'HebrÃ³nBarcelona, Spain Hospital Universitario Reina SofiaCÃ³rdoba, Spain Hospital General Universitario De ElcheElche, Spain Hospital Universitari De Santa MariaLleida, Spain Hospital General Universitario Gregorio MaraÃ±Ã³nMadrid, Spain Hospital Universitario 12 De OctubreMadrid, Spain Hospital Universitario La PazMadrid, Spain ClÃ­nica Universidad De NavarraPamplona, Spain Hospital Universitario De SalamancaSalamanca, Spain Hospital Universitario MarquÃ©s De ValdecillaSantander, Spain Hospital Universitario Virgen MacarenaSevilla, Spain Hospital Universitario Y PolitÃ©cnico De La FeValencia, Spain Complejo Asistencial De Zamora Hospital Virgen De La ConchaZamora, Spain Hospital Viamed MontecanalZaragoza, Spain|Barnsley, United Kingdom Research Institute For The Care Of Older PeopleBath, United Kingdom Belfast Health And Social Care TrustBelfast, United Kingdom Mac Clinical Research - BlackpoolBlackpool, United Kingdom Mac Clinical Research - CannockCannock, United Kingdom Mac Clinical Research - LeedsLeeds, United Kingdom Re:Cognition Health - LondonLondon, United Kingdom South London And Maudsley Nhs Foundation TrustLondon, United Kingdom Mac Clinical Research - ManchesterManchester, United Kingdom Northamptonshire Healthcare Nhs Foundation TrustNorthampton, United Kingdom Mac Clinical Research - LiverpoolPrescot, United Kingdom Southern Health Nhs Foundation TrustSouthampton, United Kingdom Avon And Wiltshire Mental Health Partnership Nhs TrustSwindon, United Kingdom North West Boroughs Healthcare Nhs Foundation TrustWarrington, United Kingdom|Little Rock, Arkansas, United States, 72205|Boca Raton, Florida, United States, 33487 Helix Biomedics LlcBoynton Beach, Florida, United States, 33436 Alzheimer'S Research And Treatment CenterLake Worth, Florida, United States, 33449 Meridien Research - Lakeland SiteLakeland, Florida, United States, 33805 Zynak Clinical ServicesLauderdale Lakes, Florida, United States, 33313 Crystal Biomedical Research, LlcMiami Lakes, Florida, United States, 33014 City Medical Group RcMiami, Florida, United States, 33126 Finlay Medical Research CorpMiami, Florida, United States, 33126 Clinical Research Associates Of South FloridaMiami, Florida, United States, 33172 Research Institute Of West KendallMiami, Florida, United States, 33186 Bayside Clinical ResearchNew Port Richey, Florida, United States, 34655|Caro, Michigan, United States, 48723|Chesterfield, Missouri, United States, 63005|Oklahoma City, Oklahoma, United States, 73102","Arkansas|Florida|Michigan|Missouri|Oklahoma","Australia|Bulgaria|Czechia|France|Hungary|Italy|Poland|South Africa|Spain|United Kingdom|United States","Australian Alzheimer's Research Foundation|University Multiprofile Hospital For Active Treatment Dr. Georgi Stranski|Fakultni Nemocnice U Sv. Anny V Brne|Centre Hospitalier Universitaire De Caen - HÃ´pital CÃ´te De Nacre|Dr. Kenessey Albert KÃ³rhÃ¡z-RendelÅ‘intÃ©zet|EgÃ©szsÃ©gÃ¼gyi Ã‰s SzolgÃ¡ltatÃ³ KorlÃ¡tolt FelelÅ‘ssÃ©gÅ± TÃ¡rsasÃ¡g|Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia|ÅšrÃ³dmieÅ›cie Przychodnia - Bydgoszcz|Acf Neurological Services|FundaciÃ³ Ace|Mac Clinical Research - Barnsley|Clinical Trials Inc.|Sfm Clinical Research, Llc|Onyx Clinical Research, Llc|Galen Research|Newton Clinical Research",{"$nulls":4},"2019-10-09","2020-05-25T16:35:44.439","2020-05-26T17:10:42.972","NCT03393520"]
["5ecbf3e011702c1b1b9169f6","NCT03393520","2019-11-07","Avanir","AVNR","Recruiting","Assessment of the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type","Avp-786",null,"Yes","['Avp-786']","Unknown",null,"Phase 3",3,412,"Anticipated","2017-10-13","2021-06-01",{"$nulls":5},"This study will be conducted to evaluate the efficacy, safety, and tolerability of AVP-786 compared to placebo, for the treatment of agitation in participants with dementia of the Alzheimer's type.","Eligible participants for this study must have a diagnosis of probable Alzheimer's disease (AD) and must have clinically significant, moderate/severe agitation secondary to AD.\n\nThis is a multicenter, randomized, double-blind, placebo-controlled, parallel-design study, consisting of 12 weeks of treatment.\n\nApproximately 412 participants will be enrolled at approximately 90 centers worldwide.\n\nStudy medication will be administered orally twice-daily from Day 1 through Day 85. Screening will occur within approximately 4 weeks prior to randomization. Following screening procedures for assessment of inclusion and exclusion criteria, eligible participants will be randomized into the study.","A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-design Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type","17-AVP-786-305","Agitation in Patients With Dementia of the Alzheimer's Type","Alzheimer Disease|Dementia","Neurocognitive Disorders","Central Nervous System","Placebo Comparator|Experimental","Placebo|AVP-786; Dose 1|AVP-786; Dose 2","Participants will be assigned to treatment with placebo capsules administered twice a day over a 12-week period.|Participants will receive AVP-786 (Dose 1) capsules administered twice a day over a 12-week period.|Participants will receive AVP-786 (Dose 2) capsules administered twice a day over a 12-week period.","Drug","Placebo|AVP-786","oral capsules",null,"Placebo|AVP-786; Dose 1|AVP-786; Dose 2","\n\n * Diagnosis of probable Alzheimer's Disease (AD) according to the 2011 National Institute on Aging-Alzheimer's Association (NIA-AA) working groups criteria\n * Participants with clinically significant, moderate/severe agitation at the time of screening and for at least 2 weeks prior to randomization that interferes with their daily routine and for which a prescription medication has been indicated, in the opinion of the investigator\n * The diagnosis of agitation must meet the provisional consensus definition of agitation in participants with cognitive disorders developed by the International Psychogeriatric Association (IPA) Agitation Definition Work Group.\n * A Clinical Global Impression of Severity of Illness scale for Agitation (CGIS-Agitation) score of â‰¥ 4 (moderately ill) at screening and baseline\n * Participants must have a reliable caregiver who is able and willing to comply with study procedures, including not administering any prohibited medications during the course of the study.\n * Caregiver who is able and willing to comply with all required study procedures. In order to qualify as a reliable informant (i.e., caregiver) capable of assessing changes in participant's condition during the study, the individual must spend a minimum of 2 hours per day for 4 days per week with the participant.\n\n","\n\n * Participants with dementia predominantly of the non-Alzheimer's type (e.g., vascular dementia, frontotemporal dementia, Parkinson's disease, substance-induced dementia)\n * Participants with symptoms of agitation that are not secondary to AD (e.g., secondary to pain, other psychiatric disorder, or delirium)\n * Participants with co-existent clinically significant or unstable systemic diseases that could confound the interpretation of the safety results of the study (e.g., malignancy, poorly controlled diabetes, poorly controlled hypertension, unstable pulmonary, renal or hepatic disease, unstable ischemic cardiac disease, dilated cardiomyopathy, or unstable valvular heart disease)\n * Participants with myasthenia gravis",{"$nulls":4},"Actual","2018-01-08","Actual","Anticipated","2021-06-01","Anticipated","2019-11-01","2018-01-03","2018-01-03","2019-11-06","Yes","Agitation\nDementia of the Alzheimer's type\nAlzheimer's disease\nAVP-786\nDeudextromethorphan hydrobromide\nQuinidine sulfate","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","50 Years","90 Years","All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"2017-001339-38","EudraCT Number","Change from Baseline to Week 12 in the Cohen-Mansfield Agitation Inventory (CMAI) Composite Score","Baseline; Week 12",null,"Change from Baseline to Week 12 in the Modified Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change for Agitation (mADCS-CGIC-Agitation) Score|Change from Baseline to Week 12 in the Neuropsychiatric Inventory (NPI) Agitation/Aggression Domain Score|Change from Baseline to Week 12 in the NPI Caregiver Distress Score|Change from Baseline to Week 12 in the NPI Aberrant Motor Behavior Domain Score|Change from Baseline to Week 12 in the NPI Irritability/Lability Domain Score|Change from Baseline to Week 12 in the NPI Total Score|Change from Baseline to Week 12 in the Clinical Global Impression of Severity (CGIS)-Agitation Domain Score|Change from Baseline to Week 12 in the ADCS-CGIC for Overall Clinical Status Rating|Change from Baseline to Week 12 in the Patient Global Impression of Change (PGIC) Scale Score|Change from Baseline to Week 12 in the Dementia Quality of Life (DEMQOL) Scale Score|Change from Baseline to Week 12 in EuroQol-5 Dimension-5 Level (EQ-5D-5L) Dimension Scores|Change from Baseline to Week 12 in the Resource Utilization in Dementia (RUD) Scale Score","Baseline; Week 12",{"$nulls":4},"Nedlands, Australia Neuro Trials Victoria Pty LtdNoble Park, Australia The Alfred HospitalParkville, Australia|Pleven, Bulgaria Center For Mental Health - RuseRuse, Bulgaria First Multiprofile Hospital For Active Treatment SofiaSofia, Bulgaria Medical Center StimulSofia, Bulgaria Medical Center Sveti NaumSofia, Bulgaria University Multiprofile Hospital For Active Treatment AlexandrovskaSofia, Bulgaria Medica Plus Medical CenterVeliko Tarnovo, Bulgaria|Brno, Czechia FakultnÃ­ Nemocnice Hradec KrÃ¡lovÃ©Hradec KralovÃ©, Czechia NeuropsychiatriehkHradec KrÃ¡lovÃ©, Czechia Brain-SoultherapyKladno, Czechia SupervizeKutnÃ¡ Hora, Czechia Ad71Praha, Czechia ClintrialPraha, Czechia Neurologicka Ambulance - ForbeliPraha, Czechia NeuropsychiatriePraha, Czechia Vestra ClinicsRychnov Nad KnÄ›Å¾nou, Czechia|Caen Cedex 9, France Centre Hospitalier De CalaisCalais, France Centre Hospitalier Universitaire Dijon BourgognDijon Cedex, France Centre Hospitalier Universitaire De PoitiersPoitiers, France Centre Hospitalier Universitaire De Saint-Ã‰tienne - HÃ´pital NordSaint-Etienne, France Centre Hospitalier Universitaire Toulouse - Casselardit AncelyToulouse, France Centre Hospitalier Universitaire De Nancy - HÃ´pital De BraboisVandoeuvre Les Nancy, France|Balassagyarmat, Hungary Semmelweis EgyetemBudapest, Hungary Szent Janos Korhaz Es Eszak-Budai Egyesitett KorhazakBudapest, Hungary Debreceni Egyetem Kenezy Gyula Egyetemi KorhazDebrecen, Hungary Valeomed Egeszsegugyi Es Szolgaltato KftEsztergom, Hungary Cru|Miskolc, Hungary Szabolcs-Szatmar-Bereg Megyei Korhazak Es Egyetemi OktatokorhazNyiregyhaza, Hungary PsychotechPecs, Hungary Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai KozpontSzeged, Hungary FejÃ©r Megyei Szent GyÃ¶rgy Egyetemi OktatÃ³ KÃ³rhÃ¡zSzÃ©kesfehÃ©rvÃ¡r, Hungary|Brescia, Italy Centro San Giovanni Di Dio - FatebenefratelliBrescia, Italy UniversitÃ  Degli Studi G.D'Annunzio Chieti PescaraChieti, Italy Fondazione Irccs Ca' Granda Ospedale Maggiore PoliclinicoMilano, Italy Azienda Ospedaliera San Gerardo Di MonzaMonza, Italy Azienda Ospedaliera Sant'AndreaRoma, Italy Fondazione Santa Lucia - Istituto Di Ricovero E Cura A Carattere ScientificoRoma, Italy|Bydgoszcz, Poland Centrum Medyczne SensemedChorzÃ³w, Poland Care ClinicKatowice, Poland Wielospecjalistyczna Poradnia Lekarska SynapsisKatowice, Poland Krakowska Akademia NeurologiiKrakÃ³w, Poland Pratia Mcm KrakÃ³wKrakÃ³w, Poland Medycyna MilorzabLodz, Poland Neurologiczny Niepubliczny ZakÅ‚ad Opieki ZdrowotnejPlewiska, Poland Centrum Medyczne HcpPoznaÅ„, Poland Solumed Centrum MedycznePoznaÅ„, Poland Centrum Medyczne EuromedisSzczecin, Poland Centrum Medyczne NeuroprotectWarszawa, Poland Centrum Medyczne Pratia WarszawaWarszawa, Poland|Cape Town, South Africa Cape Trial CentreCape Town, South Africa Flexivest Fourteen Research CentreCape Town, South Africa Apollo Clinical ResearchJohannesburg, South Africa Medical And Dental CentreRosebank, South Africa Dr. Chisto Carel CoetzeeUmhlanga, South Africa|Barcelona, Spain FundaciÃ³ Hospital De La Santa Creu I Sant PauBarcelona, Spain Hospital Clinic De BarcelonaBarcelona, Spain Hospital Universitari Vall D'HebrÃ³nBarcelona, Spain Hospital Universitario Reina SofiaCÃ³rdoba, Spain Hospital General Universitario De ElcheElche, Spain Hospital Universitari De Santa MariaLleida, Spain Hospital General Universitario Gregorio MaraÃ±Ã³nMadrid, Spain Hospital Universitario 12 De OctubreMadrid, Spain Hospital Universitario La PazMadrid, Spain ClÃ­nica Universidad De NavarraPamplona, Spain Hospital Universitario De SalamancaSalamanca, Spain Hospital Universitario MarquÃ©s De ValdecillaSantander, Spain Hospital Universitario Virgen MacarenaSevilla, Spain Hospital Universitario Y PolitÃ©cnico De La FeValencia, Spain Complejo Asistencial De Zamora Hospital Virgen De La ConchaZamora, Spain Hospital Viamed MontecanalZaragoza, Spain|Barnsley, United Kingdom Research Institute For The Care Of Older PeopleBath, United Kingdom Belfast Health And Social Care TrustBelfast, United Kingdom Mac Clinical Research - BlackpoolBlackpool, United Kingdom Mac Clinical Research - CannockCannock, United Kingdom Mac Clinical Research - LeedsLeeds, United Kingdom Re:Cognition Health - LondonLondon, United Kingdom South London And Maudsley Nhs Foundation TrustLondon, United Kingdom Mac Clinical Research - ManchesterManchester, United Kingdom Northamptonshire Healthcare Nhs Foundation TrustNorthampton, United Kingdom Mac Clinical Research - LiverpoolPrescot, United Kingdom Southern Health Nhs Foundation TrustSouthampton, United Kingdom Avon And Wiltshire Mental Health Partnership Nhs TrustSwindon, United Kingdom North West Boroughs Healthcare Nhs Foundation TrustWarrington, United Kingdom|Scottsdale, Arizona, United States, 85254|Little Rock, Arkansas, United States, 72205|Boca Raton, Florida, United States, 33487 Helix Biomedics LlcBoynton Beach, Florida, United States, 33436 Alzheimer'S Research And Treatment CenterLake Worth, Florida, United States, 33449 Meridien Research - Lakeland SiteLakeland, Florida, United States, 33805 Zynak Clinical ServicesLauderdale Lakes, Florida, United States, 33313 Crystal Biomedical Research, LlcMiami Lakes, Florida, United States, 33014 City Medical Group RcMiami, Florida, United States, 33126 Finlay Medical Research CorpMiami, Florida, United States, 33126 Clinical Research Associates Of South FloridaMiami, Florida, United States, 33172 Pharmax Research Of South FloridaMiami, Florida, United States, 33175 Research Institute Of West KendallMiami, Florida, United States, 33186 Bayside Clinical ResearchNew Port Richey, Florida, United States, 34655|Decatur, Georgia, United States, 30033|Caro, Michigan, United States, 48723|Chesterfield, Missouri, United States, 63005|Beachwood, Ohio, United States, 44122|Oklahoma City, Oklahoma, United States, 73102|Bellevue, Washington, United States, 98007","Arizona|Arkansas|Florida|Georgia|Michigan|Missouri|Ohio|Oklahoma|Washington","Australia|Bulgaria|Czechia|France|Hungary|Italy|Poland|South Africa|Spain|United Kingdom|United States","Australian Alzheimer's Research Foundation|University Multiprofile Hospital For Active Treatment Dr. Georgi Stranski|Fakultni Nemocnice U Sv. Anny V Brne|Centre Hospitalier Universitaire De Caen - HÃ´pital CÃ´te De Nacre|Dr. Kenessey Albert KÃ³rhÃ¡z-RendelÅ‘intÃ©zet|EgÃ©szsÃ©gÃ¼gyi Ã‰s SzolgÃ¡ltatÃ³ KorlÃ¡tolt FelelÅ‘ssÃ©gÅ± TÃ¡rsasÃ¡g|Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia|ÅšrÃ³dmieÅ›cie Przychodnia - Bydgoszcz|Acf Neurological Services|FundaciÃ³ Ace|Mac Clinical Research - Barnsley|Perseverance Research Center|Clinical Trials Inc.|Sfm Clinical Research, Llc|Neurostudies. Net, Llc|Onyx Clinical Research, Llc|Galen Research|Insight Clinical Trials Llc|Newton Clinical Research|Northwest Clinical Research Center",{"$nulls":4},"2019-11-06","2020-05-25T16:35:44.404","2020-05-26T17:10:42.972","NCT03393520"]
["5ecbf3e0e2561b1b11905ce0","NCT03393520","2019-11-27","Avanir","AVNR","Recruiting","Assessment of the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type","Avp-786",null,"Yes","['Avp-786']","Unknown",null,"Phase 3",3,412,"Anticipated","2017-10-13","2021-06-01",{"$nulls":5},"This study will be conducted to evaluate the efficacy, safety, and tolerability of AVP-786 compared to placebo, for the treatment of agitation in participants with dementia of the Alzheimer's type.","Eligible participants for this study must have a diagnosis of probable Alzheimer's disease (AD) and must have clinically significant, moderate/severe agitation secondary to AD.\n\nThis is a multicenter, randomized, double-blind, placebo-controlled, parallel-design study, consisting of 12 weeks of treatment.\n\nApproximately 412 participants will be enrolled at approximately 90 centers worldwide.\n\nStudy medication will be administered orally twice-daily from Day 1 through Day 85. Screening will occur within approximately 4 weeks prior to randomization. Following screening procedures for assessment of inclusion and exclusion criteria, eligible participants will be randomized into the study.","A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-design Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type","17-AVP-786-305","Agitation in Patients With Dementia of the Alzheimer's Type","Alzheimer Disease|Dementia","Neurocognitive Disorders","Central Nervous System","Placebo Comparator|Experimental","Placebo|AVP-786; Dose 1|AVP-786; Dose 2","Participants will be assigned to treatment with placebo capsules administered twice a day over a 12-week period.|Participants will receive AVP-786 (Dose 1) capsules administered twice a day over a 12-week period.|Participants will receive AVP-786 (Dose 2) capsules administered twice a day over a 12-week period.","Drug","Placebo|AVP-786","oral capsules",null,"Placebo|AVP-786; Dose 1|AVP-786; Dose 2","\n\n * Diagnosis of probable Alzheimer's Disease (AD) according to the 2011 National Institute on Aging-Alzheimer's Association (NIA-AA) working groups criteria\n * Participants with clinically significant, moderate/severe agitation at the time of screening and for at least 2 weeks prior to randomization that interferes with their daily routine and for which a prescription medication has been indicated, in the opinion of the investigator\n * The diagnosis of agitation must meet the provisional consensus definition of agitation in participants with cognitive disorders developed by the International Psychogeriatric Association (IPA) Agitation Definition Work Group.\n * A Clinical Global Impression of Severity of Illness scale for Agitation (CGIS-Agitation) score of â‰¥ 4 (moderately ill) at screening and baseline\n * Participants must have a reliable caregiver who is able and willing to comply with study procedures, including not administering any prohibited medications during the course of the study.\n * Caregiver who is able and willing to comply with all required study procedures. In order to qualify as a reliable informant (i.e., caregiver) capable of assessing changes in participant's condition during the study, the individual must spend a minimum of 2 hours per day for 4 days per week with the participant.\n\n","\n\n * Participants with dementia predominantly of the non-Alzheimer's type (e.g., vascular dementia, frontotemporal dementia, Parkinson's disease, substance-induced dementia)\n * Participants with symptoms of agitation that are not secondary to AD (e.g., secondary to pain, other psychiatric disorder, or delirium)\n * Participants with co-existent clinically significant or unstable systemic diseases that could confound the interpretation of the safety results of the study (e.g., malignancy, poorly controlled diabetes, poorly controlled hypertension, unstable pulmonary, renal or hepatic disease, unstable ischemic cardiac disease, dilated cardiomyopathy, or unstable valvular heart disease)\n * Participants with myasthenia gravis",{"$nulls":4},"Actual","2018-01-08","Actual","Anticipated","2021-06-01","Anticipated","2019-11-01","2018-01-03","2018-01-03","2019-11-26","Yes","Agitation\nDementia of the Alzheimer's type\nAlzheimer's disease\nAVP-786\nDeudextromethorphan hydrobromide\nQuinidine sulfate","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","50 Years","90 Years","All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"2017-001339-38","EudraCT Number","Change from Baseline to Week 12 in the Cohen-Mansfield Agitation Inventory (CMAI) Composite Score","Baseline; Week 12",null,"Change from Baseline to Week 12 in the Modified Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change for Agitation (mADCS-CGIC-Agitation) Score|Change from Baseline to Week 12 in the Neuropsychiatric Inventory (NPI) Agitation/Aggression Domain Score|Change from Baseline to Week 12 in the NPI Caregiver Distress Score|Change from Baseline to Week 12 in the NPI Aberrant Motor Behavior Domain Score|Change from Baseline to Week 12 in the NPI Irritability/Lability Domain Score|Change from Baseline to Week 12 in the NPI Total Score|Change from Baseline to Week 12 in the Clinical Global Impression of Severity (CGIS)-Agitation Domain Score|Change from Baseline to Week 12 in the ADCS-CGIC for Overall Clinical Status Rating|Change from Baseline to Week 12 in the Patient Global Impression of Change (PGIC) Scale Score|Change from Baseline to Week 12 in the Dementia Quality of Life (DEMQOL) Scale Score|Change from Baseline to Week 12 in EuroQol-5 Dimension-5 Level (EQ-5D-5L) Dimension Scores|Change from Baseline to Week 12 in the Resource Utilization in Dementia (RUD) Scale Score","Baseline; Week 12",{"$nulls":4},"Nedlands, Australia Neuro Trials Victoria Pty LtdNoble Park, Australia The Alfred HospitalParkville, Australia|Pleven, Bulgaria Center For Mental Health - RuseRuse, Bulgaria First Multiprofile Hospital For Active Treatment SofiaSofia, Bulgaria Medical Center StimulSofia, Bulgaria Medical Center Sveti NaumSofia, Bulgaria University Multiprofile Hospital For Active Treatment AlexandrovskaSofia, Bulgaria Medica Plus Medical CenterVeliko Tarnovo, Bulgaria|Brno, Czechia FakultnÃ­ Nemocnice Hradec KrÃ¡lovÃ©Hradec KralovÃ©, Czechia NeuropsychiatriehkHradec KrÃ¡lovÃ©, Czechia Brain-SoultherapyKladno, Czechia SupervizeKutnÃ¡ Hora, Czechia Ad71Praha, Czechia ClintrialPraha, Czechia Neurologicka Ambulance - ForbeliPraha, Czechia NeuropsychiatriePraha, Czechia Vestra ClinicsRychnov Nad KnÄ›Å¾nou, Czechia|Caen Cedex 9, France Centre Hospitalier De CalaisCalais, France Centre Hospitalier Universitaire Dijon BourgognDijon Cedex, France Centre Hospitalier Universitaire De PoitiersPoitiers, France Centre Hospitalier Universitaire De Saint-Ã‰tienne - HÃ´pital NordSaint-Etienne, France Centre Hospitalier Universitaire Toulouse - Casselardit AncelyToulouse, France Centre Hospitalier Universitaire De Nancy - HÃ´pital De BraboisVandoeuvre Les Nancy, France|Balassagyarmat, Hungary Semmelweis EgyetemBudapest, Hungary Szent Janos Korhaz Es Eszak-Budai Egyesitett KorhazakBudapest, Hungary Debreceni Egyetem Kenezy Gyula Egyetemi KorhazDebrecen, Hungary Valeomed Egeszsegugyi Es Szolgaltato KftEsztergom, Hungary Cru|Miskolc, Hungary Szabolcs-Szatmar-Bereg Megyei Korhazak Es Egyetemi OktatokorhazNyiregyhaza, Hungary PsychotechPecs, Hungary Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai KozpontSzeged, Hungary FejÃ©r Megyei Szent GyÃ¶rgy Egyetemi OktatÃ³ KÃ³rhÃ¡zSzÃ©kesfehÃ©rvÃ¡r, Hungary|Brescia, Italy Centro San Giovanni Di Dio - FatebenefratelliBrescia, Italy UniversitÃ  Degli Studi G.D'Annunzio Chieti PescaraChieti, Italy Fondazione Irccs Ca' Granda Ospedale Maggiore PoliclinicoMilano, Italy Azienda Ospedaliera San Gerardo Di MonzaMonza, Italy Azienda Ospedaliera Sant'AndreaRoma, Italy Fondazione Santa Lucia - Istituto Di Ricovero E Cura A Carattere ScientificoRoma, Italy|Bydgoszcz, Poland Centrum Medyczne SensemedChorzÃ³w, Poland Care ClinicKatowice, Poland Wielospecjalistyczna Poradnia Lekarska SynapsisKatowice, Poland Krakowska Akademia NeurologiiKrakÃ³w, Poland Pratia Mcm KrakÃ³wKrakÃ³w, Poland Medycyna MilorzabLodz, Poland Neurologiczny Niepubliczny ZakÅ‚ad Opieki ZdrowotnejPlewiska, Poland Centrum Medyczne HcpPoznaÅ„, Poland Solumed Centrum MedycznePoznaÅ„, Poland Centrum Medyczne EuromedisSzczecin, Poland Centrum Medyczne NeuroprotectWarszawa, Poland Centrum Medyczne Pratia WarszawaWarszawa, Poland|Cape Town, South Africa Cape Trial CentreCape Town, South Africa Flexivest Fourteen Research CentreCape Town, South Africa Apollo Clinical ResearchJohannesburg, South Africa Medical And Dental CentreRosebank, South Africa Dr. Chisto Carel CoetzeeUmhlanga, South Africa|Barcelona, Spain FundaciÃ³ Hospital De La Santa Creu I Sant PauBarcelona, Spain Hospital Clinic De BarcelonaBarcelona, Spain Hospital Universitari Vall D'HebrÃ³nBarcelona, Spain Hospital Universitario Reina SofiaCÃ³rdoba, Spain Hospital General Universitario De ElcheElche, Spain Hospital Universitari De Santa MariaLleida, Spain Hospital General Universitario Gregorio MaraÃ±Ã³nMadrid, Spain Hospital Universitario 12 De OctubreMadrid, Spain Hospital Universitario La PazMadrid, Spain ClÃ­nica Universidad De NavarraPamplona, Spain Hospital Universitario De SalamancaSalamanca, Spain Hospital Universitario MarquÃ©s De ValdecillaSantander, Spain Hospital Universitario Virgen MacarenaSevilla, Spain Hospital Universitario Y PolitÃ©cnico De La FeValencia, Spain Complejo Asistencial De Zamora Hospital Virgen De La ConchaZamora, Spain Hospital Viamed MontecanalZaragoza, Spain|Barnsley, United Kingdom Research Institute For The Care Of Older PeopleBath, United Kingdom Belfast Health And Social Care TrustBelfast, United Kingdom Mac Clinical Research - BlackpoolBlackpool, United Kingdom Mac Clinical Research - CannockCannock, United Kingdom Mac Clinical Research - LeedsLeeds, United Kingdom Re:Cognition Health - LondonLondon, United Kingdom South London And Maudsley Nhs Foundation TrustLondon, United Kingdom Mac Clinical Research - ManchesterManchester, United Kingdom Northamptonshire Healthcare Nhs Foundation TrustNorthampton, United Kingdom Mac Clinical Research - LiverpoolPrescot, United Kingdom Southern Health Nhs Foundation TrustSouthampton, United Kingdom Avon And Wiltshire Mental Health Partnership Nhs TrustSwindon, United Kingdom North West Boroughs Healthcare Nhs Foundation TrustWarrington, United Kingdom|Scottsdale, Arizona, United States, 85254|Little Rock, Arkansas, United States, 72205|Boca Raton, Florida, United States, 33487 Helix Biomedics LlcBoynton Beach, Florida, United States, 33436 Alzheimer'S Research And Treatment CenterLake Worth, Florida, United States, 33449 Meridien Research - Lakeland SiteLakeland, Florida, United States, 33805 Zynak Clinical ServicesLauderdale Lakes, Florida, United States, 33313 Crystal Biomedical Research, LlcMiami Lakes, Florida, United States, 33014 City Medical Group RcMiami, Florida, United States, 33126 Finlay Medical Research CorpMiami, Florida, United States, 33126 Clinical Research Associates Of South FloridaMiami, Florida, United States, 33172 Pharmax Research Of South FloridaMiami, Florida, United States, 33175 Research Institute Of West KendallMiami, Florida, United States, 33186 Bayside Clinical ResearchNew Port Richey, Florida, United States, 34655|Decatur, Georgia, United States, 30033|Caro, Michigan, United States, 48723|Chesterfield, Missouri, United States, 63005|Orangeburg, New York, United States, 10962|Beachwood, Ohio, United States, 44122|Oklahoma City, Oklahoma, United States, 73102|Desoto, Texas, United States, 75115|Bellevue, Washington, United States, 98007","Arizona|Arkansas|Florida|Georgia|Michigan|Missouri|New York|Ohio|Oklahoma|Texas|Washington","Australia|Bulgaria|Czechia|France|Hungary|Italy|Poland|South Africa|Spain|United Kingdom|United States","Australian Alzheimer's Research Foundation|University Multiprofile Hospital For Active Treatment Dr. Georgi Stranski|Fakultni Nemocnice U Sv. Anny V Brne|Centre Hospitalier Universitaire De Caen - HÃ´pital CÃ´te De Nacre|Dr. Kenessey Albert KÃ³rhÃ¡z-RendelÅ‘intÃ©zet|EgÃ©szsÃ©gÃ¼gyi Ã‰s SzolgÃ¡ltatÃ³ KorlÃ¡tolt FelelÅ‘ssÃ©gÅ± TÃ¡rsasÃ¡g|Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia|ÅšrÃ³dmieÅ›cie Przychodnia - Bydgoszcz|Acf Neurological Services|FundaciÃ³ Ace|Mac Clinical Research - Barnsley|Perseverance Research Center|Clinical Trials Inc.|Sfm Clinical Research, Llc|Neurostudies. Net, Llc|Onyx Clinical Research, Llc|Galen Research|Nathan S. Kline Institute For Psychiatric Research|Insight Clinical Trials Llc|Newton Clinical Research|Insite Clinical Research|Northwest Clinical Research Center",{"$nulls":4},"2019-11-26","2020-05-25T16:35:44.941","2020-05-26T17:10:42.972","NCT03393520"]
["5ecbf3e0fe30261b1a0481e4","NCT03393520","2019-12-24","Avanir","AVNR","Recruiting","Assessment of the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type","Avp-786",null,"Yes","['Avp-786']","Unknown",null,"Phase 3",3,412,"Anticipated","2017-10-13","2021-06-01",{"$nulls":5},"This study will be conducted to evaluate the efficacy, safety, and tolerability of AVP-786 compared to placebo, for the treatment of agitation in participants with dementia of the Alzheimer's type.","Eligible participants for this study must have a diagnosis of probable Alzheimer's disease (AD) and must have clinically significant, moderate/severe agitation secondary to AD.\n\nThis is a multicenter, randomized, double-blind, placebo-controlled, parallel-design study, consisting of 12 weeks of treatment.\n\nApproximately 412 participants will be enrolled at approximately 90 centers worldwide.\n\nStudy medication will be administered orally twice-daily from Day 1 through Day 85. Screening will occur within approximately 4 weeks prior to randomization. Following screening procedures for assessment of inclusion and exclusion criteria, eligible participants will be randomized into the study.","A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-design Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type","17-AVP-786-305","Agitation in Patients With Dementia of the Alzheimer's Type","Alzheimer Disease|Dementia","Neurocognitive Disorders","Central Nervous System","Placebo Comparator|Experimental","Placebo|AVP-786; Dose 1|AVP-786; Dose 2","Participants will be assigned to treatment with placebo capsules administered twice a day over a 12-week period.|Participants will receive AVP-786 (Dose 1) capsules administered twice a day over a 12-week period.|Participants will receive AVP-786 (Dose 2) capsules administered twice a day over a 12-week period.","Drug","Placebo|AVP-786","oral capsules",null,"Placebo|AVP-786; Dose 1|AVP-786; Dose 2","\n\n * Diagnosis of probable Alzheimer's Disease (AD) according to the 2011 National Institute on Aging-Alzheimer's Association (NIA-AA) working groups criteria\n * Participants with clinically significant, moderate/severe agitation at the time of screening and for at least 2 weeks prior to randomization that interferes with their daily routine and for which a prescription medication has been indicated, in the opinion of the investigator\n * The diagnosis of agitation must meet the provisional consensus definition of agitation in participants with cognitive disorders developed by the International Psychogeriatric Association (IPA) Agitation Definition Work Group.\n * A Clinical Global Impression of Severity of Illness scale for Agitation (CGIS-Agitation) score of â‰¥ 4 (moderately ill) at screening and baseline\n * Participants must have a reliable caregiver who is able and willing to comply with study procedures, including not administering any prohibited medications during the course of the study.\n * Caregiver who is able and willing to comply with all required study procedures. In order to qualify as a reliable informant (i.e., caregiver) capable of assessing changes in participant's condition during the study, the individual must spend a minimum of 2 hours per day for 4 days per week with the participant.\n\n","\n\n * Participants with dementia predominantly of the non-Alzheimer's type (e.g., vascular dementia, frontotemporal dementia, Parkinson's disease, substance-induced dementia)\n * Participants with symptoms of agitation that are not secondary to AD (e.g., secondary to pain, other psychiatric disorder, or delirium)\n * Participants with co-existent clinically significant or unstable systemic diseases that could confound the interpretation of the safety results of the study (e.g., malignancy, poorly controlled diabetes, poorly controlled hypertension, unstable pulmonary, renal or hepatic disease, unstable ischemic cardiac disease, dilated cardiomyopathy, or unstable valvular heart disease)\n * Participants with myasthenia gravis",{"$nulls":4},"Actual","2018-01-08","Actual","Anticipated","2021-06-01","Anticipated","2019-12-01","2018-01-03","2018-01-03","2019-12-20","Yes","Agitation\nDementia of the Alzheimer's type\nAlzheimer's disease\nAVP-786\nDeudextromethorphan hydrobromide\nQuinidine sulfate","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","50 Years","90 Years","All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"2017-001339-38","EudraCT Number","Change from Baseline to Week 12 in the Cohen-Mansfield Agitation Inventory (CMAI) Composite Score","Baseline; Week 12",null,"Change from Baseline to Week 12 in the Modified Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change for Agitation (mADCS-CGIC-Agitation) Score|Change from Baseline to Week 12 in the Neuropsychiatric Inventory (NPI) Agitation/Aggression Domain Score|Change from Baseline to Week 12 in the NPI Caregiver Distress Score|Change from Baseline to Week 12 in the NPI Aberrant Motor Behavior Domain Score|Change from Baseline to Week 12 in the NPI Irritability/Lability Domain Score|Change from Baseline to Week 12 in the NPI Total Score|Change from Baseline to Week 12 in the Clinical Global Impression of Severity (CGIS)-Agitation Domain Score|Change from Baseline to Week 12 in the ADCS-CGIC for Overall Clinical Status Rating|Change from Baseline to Week 12 in the Patient Global Impression of Change (PGIC) Scale Score|Change from Baseline to Week 12 in the Dementia Quality of Life (DEMQOL) Scale Score|Change from Baseline to Week 12 in EuroQol-5 Dimension-5 Level (EQ-5D-5L) Dimension Scores|Change from Baseline to Week 12 in the Resource Utilization in Dementia (RUD) Scale Score","Baseline; Week 12",{"$nulls":4},"Nedlands, Australia Neuro Trials Victoria Pty LtdNoble Park, Australia The Alfred HospitalParkville, Australia|Pleven, Bulgaria Center For Mental Health - RuseRuse, Bulgaria First Multiprofile Hospital For Active Treatment SofiaSofia, Bulgaria Medical Center StimulSofia, Bulgaria Medical Center Sveti NaumSofia, Bulgaria University Multiprofile Hospital For Active Treatment AlexandrovskaSofia, Bulgaria Medica Plus Medical CenterVeliko Tarnovo, Bulgaria|Brno, Czechia FakultnÃ­ Nemocnice Hradec KrÃ¡lovÃ©Hradec KralovÃ©, Czechia NeuropsychiatriehkHradec KrÃ¡lovÃ©, Czechia Brain-SoultherapyKladno, Czechia SupervizeKutnÃ¡ Hora, Czechia Ad71Praha, Czechia ClintrialPraha, Czechia Neurologicka Ambulance - ForbeliPraha, Czechia NeuropsychiatriePraha, Czechia Vestra ClinicsRychnov Nad KnÄ›Å¾nou, Czechia|Caen Cedex 9, France Centre Hospitalier De CalaisCalais, France Centre Hospitalier Universitaire Dijon BourgognDijon Cedex, France Centre Hospitalier Universitaire De PoitiersPoitiers, France Centre Hospitalier Universitaire De Saint-Ã‰tienne - HÃ´pital NordSaint-Etienne, France Centre Hospitalier Universitaire Toulouse - Casselardit AncelyToulouse, France Centre Hospitalier Universitaire De Nancy - HÃ´pital De BraboisVandoeuvre Les Nancy, France|Balassagyarmat, Hungary Semmelweis EgyetemBudapest, Hungary Szent Janos Korhaz Es Eszak-Budai Egyesitett KorhazakBudapest, Hungary Debreceni Egyetem Kenezy Gyula Egyetemi KorhazDebrecen, Hungary Valeomed Egeszsegugyi Es Szolgaltato KftEsztergom, Hungary Cru|Miskolc, Hungary Szabolcs-Szatmar-Bereg Megyei Korhazak Es Egyetemi OktatokorhazNyiregyhaza, Hungary PsychotechPecs, Hungary Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai KozpontSzeged, Hungary FejÃ©r Megyei Szent GyÃ¶rgy Egyetemi OktatÃ³ KÃ³rhÃ¡zSzÃ©kesfehÃ©rvÃ¡r, Hungary|Brescia, Italy Centro San Giovanni Di Dio - FatebenefratelliBrescia, Italy UniversitÃ  Degli Studi G.D'Annunzio Chieti PescaraChieti, Italy Fondazione Irccs Ca' Granda Ospedale Maggiore PoliclinicoMilano, Italy Azienda Ospedaliera San Gerardo Di MonzaMonza, Italy Azienda Sanitaria Locale Di Biella - Nuovo Ospedale Degli InfermiPonderano, Italy Azienda Ospedaliera Sant'AndreaRoma, Italy Fondazione Policlinico Tor VergataRoma, Italy Fondazione Santa Lucia - Istituto Di Ricovero E Cura A Carattere ScientificoRoma, Italy|Bydgoszcz, Poland Centrum Medyczne SensemedChorzÃ³w, Poland Care ClinicKatowice, Poland Wielospecjalistyczna Poradnia Lekarska SynapsisKatowice, Poland Krakowska Akademia NeurologiiKrakÃ³w, Poland Pratia Mcm KrakÃ³wKrakÃ³w, Poland Medycyna MilorzabLodz, Poland Neurologiczny Niepubliczny ZakÅ‚ad Opieki ZdrowotnejPlewiska, Poland Centrum Medyczne HcpPoznaÅ„, Poland Solumed Centrum MedycznePoznaÅ„, Poland Centrum Medyczne EuromedisSzczecin, Poland Centrum Medyczne NeuroprotectWarszawa, Poland Centrum Medyczne Pratia WarszawaWarszawa, Poland|Cape Town, South Africa Cape Trial CentreCape Town, South Africa Flexivest Fourteen Research CentreCape Town, South Africa Apollo Clinical ResearchJohannesburg, South Africa Medical And Dental CentreRosebank, South Africa Dr. Chisto Carel CoetzeeUmhlanga, South Africa|Barcelona, Spain FundaciÃ³ Hospital De La Santa Creu I Sant PauBarcelona, Spain Hospital Clinic De BarcelonaBarcelona, Spain Hospital Universitari Vall D'HebrÃ³nBarcelona, Spain Hospital Universitario Reina SofiaCÃ³rdoba, Spain Hospital General Universitario De ElcheElche, Spain Hospital Universitari De Santa MariaLleida, Spain Hospital General Universitario Gregorio MaraÃ±Ã³nMadrid, Spain Hospital Universitario 12 De OctubreMadrid, Spain Hospital Universitario La PazMadrid, Spain ClÃ­nica Universidad De NavarraPamplona, Spain Hospital Universitario De SalamancaSalamanca, Spain Hospital Universitario MarquÃ©s De ValdecillaSantander, Spain Hospital Universitario Virgen MacarenaSevilla, Spain Hospital Universitario Y PolitÃ©cnico De La FeValencia, Spain Complejo Asistencial De Zamora Hospital Virgen De La ConchaZamora, Spain Hospital Viamed MontecanalZaragoza, Spain|Barnsley, United Kingdom Research Institute For The Care Of Older PeopleBath, United Kingdom Belfast Health And Social Care TrustBelfast, United Kingdom Mac Clinical Research - BlackpoolBlackpool, United Kingdom Mac Clinical Research - CannockCannock, United Kingdom Mac Clinical Research - LeedsLeeds, United Kingdom Re:Cognition Health - LondonLondon, United Kingdom South London And Maudsley Nhs Foundation TrustLondon, United Kingdom Mac Clinical Research - ManchesterManchester, United Kingdom Northamptonshire Healthcare Nhs Foundation TrustNorthampton, United Kingdom Mac Clinical Research - LiverpoolPrescot, United Kingdom Southern Health Nhs Foundation TrustSouthampton, United Kingdom Avon And Wiltshire Mental Health Partnership Nhs TrustSwindon, United Kingdom North West Boroughs Healthcare Nhs Foundation TrustWarrington, United Kingdom|Scottsdale, Arizona, United States, 85254|Little Rock, Arkansas, United States, 72205|Boca Raton, Florida, United States, 33487 Helix Biomedics LlcBoynton Beach, Florida, United States, 33436 Alzheimer'S Research And Treatment CenterLake Worth, Florida, United States, 33449 Meridien Research - Lakeland SiteLakeland, Florida, United States, 33805 Zynak Clinical ServicesLauderdale Lakes, Florida, United States, 33313 Crystal Biomedical Research, LlcMiami Lakes, Florida, United States, 33014 City Medical Group RcMiami, Florida, United States, 33126 Finlay Medical Research CorpMiami, Florida, United States, 33126 Clinical Research Associates Of South FloridaMiami, Florida, United States, 33172 Pharmax Research Of South FloridaMiami, Florida, United States, 33175 Research Institute Of West Kendall[Active, Not Recruiting]Miami, Florida, United States, 33186 Bayside Clinical ResearchNew Port Richey, Florida, United States, 34655|Decatur, Georgia, United States, 30033|Caro, Michigan, United States, 48723|Chesterfield, Missouri, United States, 63005|Orangeburg, New York, United States, 10962|Beachwood, Ohio, United States, 44122|Oklahoma City, Oklahoma, United States, 73102|Desoto, Texas, United States, 75115|Bellevue, Washington, United States, 98007","Arizona|Arkansas|Florida|Georgia|Michigan|Missouri|New York|Ohio|Oklahoma|Texas|Washington","Australia|Bulgaria|Czechia|France|Hungary|Italy|Poland|South Africa|Spain|United Kingdom|United States","Australian Alzheimer's Research Foundation|University Multiprofile Hospital For Active Treatment Dr. Georgi Stranski|Fakultni Nemocnice U Sv. Anny V Brne|Centre Hospitalier Universitaire De Caen - HÃ´pital CÃ´te De Nacre|Dr. Kenessey Albert KÃ³rhÃ¡z-RendelÅ‘intÃ©zet|EgÃ©szsÃ©gÃ¼gyi Ã‰s SzolgÃ¡ltatÃ³ KorlÃ¡tolt FelelÅ‘ssÃ©gÅ± TÃ¡rsasÃ¡g|Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia|ÅšrÃ³dmieÅ›cie Przychodnia - Bydgoszcz|Acf Neurological Services|FundaciÃ³ Ace|Mac Clinical Research - Barnsley|Perseverance Research Center|Clinical Trials Inc.|Sfm Clinical Research, Llc|Neurostudies. Net, Llc|Onyx Clinical Research, Llc|Galen Research|Nathan S. Kline Institute For Psychiatric Research|Insight Clinical Trials Llc|Newton Clinical Research|Insite Clinical Research|Northwest Clinical Research Center",{"$nulls":4},"2019-12-20","2020-05-25T16:35:44.455","2020-05-26T17:10:42.972","NCT03393520"]
["5ecbf3e0feab101b15530814","NCT03393520","2020-01-27","Avanir","AVNR","Recruiting","Assessment of the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type","Avp-786",null,"Yes","['Avp-786']","Unknown",null,"Phase 3",3,412,"Anticipated","2017-10-13","2021-06-01",{"$nulls":5},"This study will be conducted to evaluate the efficacy, safety, and tolerability of AVP-786 compared to placebo, for the treatment of agitation in participants with dementia of the Alzheimer's type.","Eligible participants for this study must have a diagnosis of probable Alzheimer's disease (AD) and must have clinically significant, moderate/severe agitation secondary to AD.\n\nThis is a multicenter, randomized, double-blind, placebo-controlled, parallel-design study, consisting of 12 weeks of treatment.\n\nApproximately 412 participants will be enrolled at approximately 90 centers worldwide.\n\nStudy medication will be administered orally twice-daily from Day 1 through Day 85. Screening will occur within approximately 4 weeks prior to randomization. Following screening procedures for assessment of inclusion and exclusion criteria, eligible participants will be randomized into the study.","A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-design Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type","17-AVP-786-305","Agitation in Patients With Dementia of the Alzheimer's Type","Alzheimer Disease|Dementia","Neurocognitive Disorders","Central Nervous System","Placebo Comparator|Experimental","Placebo|AVP-786; Dose 1|AVP-786; Dose 2","Participants will be assigned to treatment with placebo capsules administered twice a day over a 12-week period.|Participants will receive AVP-786 (Dose 1) capsules administered twice a day over a 12-week period.|Participants will receive AVP-786 (Dose 2) capsules administered twice a day over a 12-week period.","Drug","Placebo|AVP-786","oral capsules",null,"Placebo|AVP-786; Dose 1|AVP-786; Dose 2","\n\n * Diagnosis of probable Alzheimer's Disease (AD) according to the 2011 National Institute on Aging-Alzheimer's Association (NIA-AA) working groups criteria\n * Participants with clinically significant, moderate/severe agitation at the time of screening and for at least 2 weeks prior to randomization that interferes with their daily routine and for which a prescription medication has been indicated, in the opinion of the investigator\n * The diagnosis of agitation must meet the provisional consensus definition of agitation in participants with cognitive disorders developed by the International Psychogeriatric Association (IPA) Agitation Definition Work Group.\n * A Clinical Global Impression of Severity of Illness scale for Agitation (CGIS-Agitation) score of â‰¥ 4 (moderately ill) at screening and baseline\n * Participants must have a reliable caregiver who is able and willing to comply with study procedures, including not administering any prohibited medications during the course of the study.\n * Caregiver who is able and willing to comply with all required study procedures. In order to qualify as a reliable informant (i.e., caregiver) capable of assessing changes in participant's condition during the study, the individual must spend a minimum of 2 hours per day for 4 days per week with the participant.\n\n","\n\n * Participants with dementia predominantly of the non-Alzheimer's type (e.g., vascular dementia, frontotemporal dementia, Parkinson's disease, substance-induced dementia)\n * Participants with symptoms of agitation that are not secondary to AD (e.g., secondary to pain, other psychiatric disorder, or delirium)\n * Participants with co-existent clinically significant or unstable systemic diseases that could confound the interpretation of the safety results of the study (e.g., malignancy, poorly controlled diabetes, poorly controlled hypertension, unstable pulmonary, renal or hepatic disease, unstable ischemic cardiac disease, dilated cardiomyopathy, or unstable valvular heart disease)\n * Participants with myasthenia gravis",{"$nulls":4},"Actual","2018-01-08","Actual","Anticipated","2021-06-01","Anticipated","2020-01-01","2018-01-03","2018-01-03","2020-01-24","Yes","Agitation\nDementia of the Alzheimer's type\nAlzheimer's disease\nAVP-786\nDeudextromethorphan hydrobromide\nQuinidine sulfate","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","50 Years","90 Years","All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"2017-001339-38","EudraCT Number","Change from Baseline to Week 12 in the Cohen-Mansfield Agitation Inventory (CMAI) Composite Score","Baseline; Week 12",null,"Change from Baseline to Week 12 in the Modified Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change for Agitation (mADCS-CGIC-Agitation) Score|Change from Baseline to Week 12 in the Neuropsychiatric Inventory (NPI) Agitation/Aggression Domain Score|Change from Baseline to Week 12 in the NPI Caregiver Distress Score|Change from Baseline to Week 12 in the NPI Aberrant Motor Behavior Domain Score|Change from Baseline to Week 12 in the NPI Irritability/Lability Domain Score|Change from Baseline to Week 12 in the NPI Total Score|Change from Baseline to Week 12 in the Clinical Global Impression of Severity (CGIS)-Agitation Domain Score|Change from Baseline to Week 12 in the ADCS-CGIC for Overall Clinical Status Rating|Change from Baseline to Week 12 in the Patient Global Impression of Change (PGIC) Scale Score|Change from Baseline to Week 12 in the Dementia Quality of Life (DEMQOL) Scale Score|Change from Baseline to Week 12 in EuroQol-5 Dimension-5 Level (EQ-5D-5L) Dimension Scores|Change from Baseline to Week 12 in the Resource Utilization in Dementia (RUD) Scale Score","Baseline; Week 12",{"$nulls":4},"Nedlands, Australia Neuro Trials Victoria Pty LtdNoble Park, Australia The Alfred HospitalParkville, Australia|Pleven, Bulgaria Center For Mental Health - RuseRuse, Bulgaria First Multiprofile Hospital For Active Treatment SofiaSofia, Bulgaria Medical Center StimulSofia, Bulgaria Medical Center Sveti NaumSofia, Bulgaria University Multiprofile Hospital For Active Treatment AlexandrovskaSofia, Bulgaria Medica Plus Medical CenterVeliko Tarnovo, Bulgaria|Brno, Czechia FakultnÃ­ Nemocnice Hradec KrÃ¡lovÃ©Hradec KralovÃ©, Czechia NeuropsychiatriehkHradec KrÃ¡lovÃ©, Czechia Brain-SoultherapyKladno, Czechia SupervizeKutnÃ¡ Hora, Czechia Ad71Praha, Czechia ClintrialPraha, Czechia Neurologicka Ambulance - ForbeliPraha, Czechia NeuropsychiatriePraha, Czechia Vestra ClinicsRychnov Nad KnÄ›Å¾nou, Czechia|Caen Cedex 9, France Centre Hospitalier De CalaisCalais, France Centre Hospitalier Universitaire Dijon BourgognDijon Cedex, France Centre Hospitalier Universitaire De PoitiersPoitiers, France Centre Hospitalier Universitaire De Saint-Ã‰tienne - HÃ´pital NordSaint-Etienne, France Centre Hospitalier Universitaire Toulouse - Casselardit AncelyToulouse, France Centre Hospitalier Universitaire De Nancy - HÃ´pital De BraboisVandoeuvre Les Nancy, France|Balassagyarmat, Hungary Semmelweis EgyetemBudapest, Hungary Szent Janos Korhaz Es Eszak-Budai Egyesitett KorhazakBudapest, Hungary Debreceni Egyetem Kenezy Gyula Egyetemi KorhazDebrecen, Hungary Valeomed Egeszsegugyi Es Szolgaltato KftEsztergom, Hungary Cru|Miskolc, Hungary Szabolcs-Szatmar-Bereg Megyei Korhazak Es Egyetemi OktatokorhazNyiregyhaza, Hungary PsychotechPecs, Hungary Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai KozpontSzeged, Hungary FejÃ©r Megyei Szent GyÃ¶rgy Egyetemi OktatÃ³ KÃ³rhÃ¡zSzÃ©kesfehÃ©rvÃ¡r, Hungary|Brescia, Italy Centro San Giovanni Di Dio - FatebenefratelliBrescia, Italy UniversitÃ  Degli Studi G.D'Annunzio Chieti PescaraChieti, Italy Fondazione Irccs Ca' Granda Ospedale Maggiore PoliclinicoMilano, Italy Azienda Ospedaliera San Gerardo Di MonzaMonza, Italy Azienda Sanitaria Locale Di Biella - Nuovo Ospedale Degli InfermiPonderano, Italy Azienda Ospedaliera Sant'AndreaRoma, Italy Fondazione Policlinico Tor VergataRoma, Italy Fondazione Santa Lucia - Istituto Di Ricovero E Cura A Carattere ScientificoRoma, Italy|Bydgoszcz, Poland Centrum Medyczne SensemedChorzÃ³w, Poland Care ClinicKatowice, Poland Wielospecjalistyczna Poradnia Lekarska SynapsisKatowice, Poland Krakowska Akademia NeurologiiKrakÃ³w, Poland Pratia Mcm KrakÃ³wKrakÃ³w, Poland Medycyna MilorzabLodz, Poland Neurologiczny Niepubliczny ZakÅ‚ad Opieki ZdrowotnejPlewiska, Poland Centrum Medyczne HcpPoznaÅ„, Poland Solumed Centrum MedycznePoznaÅ„, Poland Centrum Medyczne EuromedisSzczecin, Poland Centrum Medyczne NeuroprotectWarszawa, Poland Centrum Medyczne Pratia WarszawaWarszawa, Poland|Cape Town, South Africa Cape Trial CentreCape Town, South Africa Flexivest Fourteen Research CentreCape Town, South Africa Apollo Clinical ResearchJohannesburg, South Africa Medical And Dental CentreRosebank, South Africa Dr. Chisto Carel CoetzeeUmhlanga, South Africa|Barcelona, Spain FundaciÃ³ Hospital De La Santa Creu I Sant PauBarcelona, Spain Hospital Clinic De BarcelonaBarcelona, Spain Hospital Universitari Vall D'HebrÃ³nBarcelona, Spain Hospital Universitario Reina SofiaCÃ³rdoba, Spain Hospital General Universitario De ElcheElche, Spain Hospital Universitari De Santa MariaLleida, Spain Hospital General Universitario Gregorio MaraÃ±Ã³nMadrid, Spain Hospital Universitario 12 De OctubreMadrid, Spain Hospital Universitario La PazMadrid, Spain ClÃ­nica Universidad De NavarraPamplona, Spain Hospital Universitario De SalamancaSalamanca, Spain Hospital Universitario MarquÃ©s De ValdecillaSantander, Spain Hospital Universitario Virgen MacarenaSevilla, Spain Hospital Universitario Y PolitÃ©cnico De La FeValencia, Spain Complejo Asistencial De Zamora Hospital Virgen De La ConchaZamora, Spain Hospital Viamed MontecanalZaragoza, Spain|Barnsley, United Kingdom Research Institute For The Care Of Older PeopleBath, United Kingdom Belfast Health And Social Care TrustBelfast, United Kingdom Mac Clinical Research - BlackpoolBlackpool, United Kingdom Mac Clinical Research - CannockCannock, United Kingdom Mac Clinical Research - LeedsLeeds, United Kingdom Re:Cognition Health - LondonLondon, United Kingdom South London And Maudsley Nhs Foundation TrustLondon, United Kingdom Mac Clinical Research - ManchesterManchester, United Kingdom Northamptonshire Healthcare Nhs Foundation TrustNorthampton, United Kingdom Mac Clinical Research - LiverpoolPrescot, United Kingdom Southern Health Nhs Foundation TrustSouthampton, United Kingdom Avon And Wiltshire Mental Health Partnership Nhs TrustSwindon, United Kingdom North West Boroughs Healthcare Nhs Foundation TrustWarrington, United Kingdom|Scottsdale, Arizona, United States, 85254|Little Rock, Arkansas, United States, 72205|Boca Raton, Florida, United States, 33487 Helix Biomedics LlcBoynton Beach, Florida, United States, 33436 Alzheimer'S Research And Treatment CenterLake Worth, Florida, United States, 33449 Meridien Research - Lakeland SiteLakeland, Florida, United States, 33805 Zynak Clinical ServicesLauderdale Lakes, Florida, United States, 33313 Crystal Biomedical Research, LlcMiami Lakes, Florida, United States, 33014 City Medical Group RcMiami, Florida, United States, 33126 Finlay Medical Research CorpMiami, Florida, United States, 33126 Clinical Research Associates Of South FloridaMiami, Florida, United States, 33172 Pharmax Research Of South FloridaMiami, Florida, United States, 33175 Research Institute Of West Kendall[Active, Not Recruiting]Miami, Florida, United States, 33186 Bayside Clinical ResearchNew Port Richey, Florida, United States, 34655|Decatur, Georgia, United States, 30033|Caro, Michigan, United States, 48723|Chesterfield, Missouri, United States, 63005|Orangeburg, New York, United States, 10962|Beachwood, Ohio, United States, 44122|Oklahoma City, Oklahoma, United States, 73102|Desoto, Texas, United States, 75115|Bellevue, Washington, United States, 98007","Arizona|Arkansas|Florida|Georgia|Michigan|Missouri|New York|Ohio|Oklahoma|Texas|Washington","Australia|Bulgaria|Czechia|France|Hungary|Italy|Poland|South Africa|Spain|United Kingdom|United States","Australian Alzheimer's Research Foundation|University Multiprofile Hospital For Active Treatment Dr. Georgi Stranski|Fakultni Nemocnice U Sv. Anny V Brne|Centre Hospitalier Universitaire De Caen - HÃ´pital CÃ´te De Nacre|Dr. Kenessey Albert KÃ³rhÃ¡z-RendelÅ‘intÃ©zet|EgÃ©szsÃ©gÃ¼gyi Ã‰s SzolgÃ¡ltatÃ³ KorlÃ¡tolt FelelÅ‘ssÃ©gÅ± TÃ¡rsasÃ¡g|Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia|ÅšrÃ³dmieÅ›cie Przychodnia - Bydgoszcz|Acf Neurological Services|FundaciÃ³ Ace|Mac Clinical Research - Barnsley|Perseverance Research Center|Clinical Trials Inc.|Sfm Clinical Research, Llc|Neurostudies. Net, Llc|Onyx Clinical Research, Llc|Galen Research|Nathan S. Kline Institute For Psychiatric Research|Insight Clinical Trials Llc|Newton Clinical Research|Insite Clinical Research|Northwest Clinical Research Center",{"$nulls":4},"2020-01-24","2020-05-25T16:35:44.627","2020-05-26T17:10:42.972","NCT03393520"]
["5ecbf3e1fe30261b1a0481e5","NCT03393520","2020-03-02","Avanir","AVNR","Recruiting","Assessment of the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type","Avp-786",null,"Yes","['Avp-786']","Unknown",null,"Phase 3",3,412,"Anticipated","2017-10-13","2021-06-01",{"$nulls":5},"This study will be conducted to evaluate the efficacy, safety, and tolerability of AVP-786 compared to placebo, for the treatment of agitation in participants with dementia of the Alzheimer's type.","Eligible participants for this study must have a diagnosis of probable Alzheimer's disease (AD) and must have clinically significant, moderate/severe agitation secondary to AD.\n\nThis is a multicenter, randomized, double-blind, placebo-controlled, parallel-design study, consisting of 12 weeks of treatment.\n\nApproximately 412 participants will be enrolled at approximately 90 centers worldwide.\n\nStudy medication will be administered orally twice-daily from Day 1 through Day 85. Screening will occur within approximately 4 weeks prior to randomization. Following screening procedures for assessment of inclusion and exclusion criteria, eligible participants will be randomized into the study.","A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-design Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type","17-AVP-786-305","Agitation in Patients With Dementia of the Alzheimer's Type","Alzheimer Disease|Dementia","Neurocognitive Disorders","Central Nervous System","Placebo Comparator|Experimental","Placebo|AVP-786; Dose 1|AVP-786; Dose 2","Participants will be assigned to treatment with placebo capsules administered twice a day over a 12-week period.|Participants will receive AVP-786 (Dose 1) capsules administered twice a day over a 12-week period.|Participants will receive AVP-786 (Dose 2) capsules administered twice a day over a 12-week period.","Drug","Placebo|AVP-786","oral capsules",null,"Placebo|AVP-786; Dose 1|AVP-786; Dose 2","\n\n * Diagnosis of probable Alzheimer's Disease (AD) according to the 2011 National Institute on Aging-Alzheimer's Association (NIA-AA) working groups criteria\n * Participants with clinically significant, moderate/severe agitation at the time of screening and for at least 2 weeks prior to randomization that interferes with their daily routine and for which a prescription medication has been indicated, in the opinion of the investigator\n * The diagnosis of agitation must meet the provisional consensus definition of agitation in participants with cognitive disorders developed by the International Psychogeriatric Association (IPA) Agitation Definition Work Group.\n * A Clinical Global Impression of Severity of Illness scale for Agitation (CGIS-Agitation) score of â‰¥ 4 (moderately ill) at screening and baseline\n * Participants must have a reliable caregiver who is able and willing to comply with study procedures, including not administering any prohibited medications during the course of the study.\n * Caregiver who is able and willing to comply with all required study procedures. In order to qualify as a reliable informant (i.e., caregiver) capable of assessing changes in participant's condition during the study, the individual must spend a minimum of 2 hours per day for 4 days per week with the participant.\n\n","\n\n * Participants with dementia predominantly of the non-Alzheimer's type (e.g., vascular dementia, frontotemporal dementia, Parkinson's disease, substance-induced dementia)\n * Participants with symptoms of agitation that are not secondary to AD (e.g., secondary to pain, other psychiatric disorder, or delirium)\n * Participants with co-existent clinically significant or unstable systemic diseases that could confound the interpretation of the safety results of the study (e.g., malignancy, poorly controlled diabetes, poorly controlled hypertension, unstable pulmonary, renal or hepatic disease, unstable ischemic cardiac disease, dilated cardiomyopathy, or unstable valvular heart disease)\n * Participants with myasthenia gravis",{"$nulls":4},"Actual","2018-01-08","Actual","Anticipated","2021-06-01","Anticipated","2020-02-01","2018-01-03","2018-01-03","2020-02-27","Yes","Agitation\nDementia of the Alzheimer's type\nAlzheimer's disease\nAVP-786\nDeudextromethorphan hydrobromide\nQuinidine sulfate","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","50 Years","90 Years","All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"2017-001339-38","EudraCT Number","Change from Baseline to Week 12 in the Cohen-Mansfield Agitation Inventory (CMAI) Composite Score","Baseline; Week 12",null,"Change from Baseline to Week 12 in the Modified Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change for Agitation (mADCS-CGIC-Agitation) Score|Change from Baseline to Week 12 in the Neuropsychiatric Inventory (NPI) Agitation/Aggression Domain Score|Change from Baseline to Week 12 in the NPI Caregiver Distress Score|Change from Baseline to Week 12 in the NPI Aberrant Motor Behavior Domain Score|Change from Baseline to Week 12 in the NPI Irritability/Lability Domain Score|Change from Baseline to Week 12 in the NPI Total Score|Change from Baseline to Week 12 in the Clinical Global Impression of Severity (CGIS)-Agitation Domain Score|Change from Baseline to Week 12 in the ADCS-CGIC for Overall Clinical Status Rating|Change from Baseline to Week 12 in the Patient Global Impression of Change (PGIC) Scale Score|Change from Baseline to Week 12 in the Dementia Quality of Life (DEMQOL) Scale Score|Change from Baseline to Week 12 in EuroQol-5 Dimension-5 Level (EQ-5D-5L) Dimension Scores|Change from Baseline to Week 12 in the Resource Utilization in Dementia (RUD) Scale Score","Baseline; Week 12",{"$nulls":4},"Nedlands, Australia Neuro Trials Victoria Pty LtdNoble Park, Australia The Alfred HospitalParkville, Australia|Pleven, Bulgaria Center For Mental Health - RuseRuse, Bulgaria First Multiprofile Hospital For Active Treatment SofiaSofia, Bulgaria Medical Center StimulSofia, Bulgaria Medical Center Sveti NaumSofia, Bulgaria University Multiprofile Hospital For Active Treatment AlexandrovskaSofia, Bulgaria Medica Plus Medical CenterVeliko Tarnovo, Bulgaria|Brno, Czechia FakultnÃ­ Nemocnice Hradec KrÃ¡lovÃ©Hradec KralovÃ©, Czechia NeuropsychiatriehkHradec KrÃ¡lovÃ©, Czechia Brain-SoultherapyKladno, Czechia SupervizeKutnÃ¡ Hora, Czechia Ad71Praha, Czechia ClintrialPraha, Czechia Neurologicka Ambulance - ForbeliPraha, Czechia NeuropsychiatriePraha, Czechia Vestra ClinicsRychnov Nad KnÄ›Å¾nou, Czechia|Caen Cedex 9, France Centre Hospitalier De CalaisCalais, France Centre Hospitalier Universitaire Dijon BourgognDijon Cedex, France Centre Hospitalier Universitaire De PoitiersPoitiers, France Centre Hospitalier Universitaire De Saint-Ã‰tienne - HÃ´pital NordSaint-Etienne, France Centre Hospitalier Universitaire Toulouse - Casselardit AncelyToulouse, France Centre Hospitalier Universitaire De Nancy - HÃ´pital De BraboisVandoeuvre Les Nancy, France|Balassagyarmat, Hungary Semmelweis EgyetemBudapest, Hungary Szent Janos Korhaz Es Eszak-Budai Egyesitett KorhazakBudapest, Hungary Debreceni Egyetem Kenezy Gyula Egyetemi KorhazDebrecen, Hungary Valeomed Egeszsegugyi Es Szolgaltato KftEsztergom, Hungary Cru|Miskolc, Hungary Szabolcs-Szatmar-Bereg Megyei Korhazak Es Egyetemi OktatokorhazNyiregyhaza, Hungary PsychotechPecs, Hungary Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai KozpontSzeged, Hungary FejÃ©r Megyei Szent GyÃ¶rgy Egyetemi OktatÃ³ KÃ³rhÃ¡zSzÃ©kesfehÃ©rvÃ¡r, Hungary|Brescia, Italy Centro San Giovanni Di Dio - FatebenefratelliBrescia, Italy UniversitÃ  Degli Studi G.D'Annunzio Chieti PescaraChieti, Italy Azienda Ospedaliero - Universitaria CareggiFirenze, Italy Fondazione Irccs Ca' Granda Ospedale Maggiore PoliclinicoMilano, Italy Azienda Ospedaliera San Gerardo Di MonzaMonza, Italy Azienda Sanitaria Locale Di Biella - Nuovo Ospedale Degli InfermiPonderano, Italy Azienda Ospedaliera Sant'AndreaRoma, Italy Fondazione Policlinico Tor VergataRoma, Italy Fondazione Santa Lucia - Istituto Di Ricovero E Cura A Carattere ScientificoRoma, Italy|Bydgoszcz, Poland Centrum Medyczne SensemedChorzÃ³w, Poland Care ClinicKatowice, Poland Wielospecjalistyczna Poradnia Lekarska SynapsisKatowice, Poland Krakowska Akademia NeurologiiKrakÃ³w, Poland Pratia Mcm KrakÃ³wKrakÃ³w, Poland Medycyna MilorzabLodz, Poland Neurologiczny Niepubliczny ZakÅ‚ad Opieki ZdrowotnejPlewiska, Poland Centrum Medyczne HcpPoznaÅ„, Poland Solumed Centrum MedycznePoznaÅ„, Poland Centrum Medyczne EuromedisSzczecin, Poland Centrum Medyczne NeuroprotectWarszawa, Poland Centrum Medyczne Pratia WarszawaWarszawa, Poland|Cape Town, South Africa Cape Trial CentreCape Town, South Africa Flexivest Fourteen Research CentreCape Town, South Africa Apollo Clinical ResearchJohannesburg, South Africa Medical And Dental CentreRosebank, South Africa Dr. Chisto Carel CoetzeeUmhlanga, South Africa|Barcelona, Spain FundaciÃ³ Hospital De La Santa Creu I Sant PauBarcelona, Spain Hospital Clinic De BarcelonaBarcelona, Spain Hospital Universitari Vall D'HebrÃ³nBarcelona, Spain Hospital Universitario Reina SofiaCÃ³rdoba, Spain Hospital General Universitario De ElcheElche, Spain Hospital Universitari De Santa MariaLleida, Spain Hospital General Universitario Gregorio MaraÃ±Ã³nMadrid, Spain Hospital Universitario 12 De OctubreMadrid, Spain Hospital Universitario La PazMadrid, Spain ClÃ­nica Universidad De NavarraPamplona, Spain Hospital Universitario De SalamancaSalamanca, Spain Hospital Universitario MarquÃ©s De ValdecillaSantander, Spain Hospital Universitario Virgen MacarenaSevilla, Spain Hospital Universitario Y PolitÃ©cnico De La FeValencia, Spain Complejo Asistencial De Zamora Hospital Virgen De La ConchaZamora, Spain Hospital Viamed MontecanalZaragoza, Spain|Barnsley, United Kingdom Research Institute For The Care Of Older PeopleBath, United Kingdom Belfast Health And Social Care TrustBelfast, United Kingdom Mac Clinical Research - BlackpoolBlackpool, United Kingdom Mac Clinical Research - CannockCannock, United Kingdom Mac Clinical Research - LeedsLeeds, United Kingdom Re:Cognition Health - LondonLondon, United Kingdom South London And Maudsley Nhs Foundation TrustLondon, United Kingdom Mac Clinical Research - ManchesterManchester, United Kingdom Northamptonshire Healthcare Nhs Foundation TrustNorthampton, United Kingdom Mac Clinical Research - LiverpoolPrescot, United Kingdom Southern Health Nhs Foundation TrustSouthampton, United Kingdom Avon And Wiltshire Mental Health Partnership Nhs TrustSwindon, United Kingdom North West Boroughs Healthcare Nhs Foundation TrustWarrington, United Kingdom|Phoenix, Arizona, United States, 85048 Perseverance Research CenterScottsdale, Arizona, United States, 85254|Little Rock, Arkansas, United States, 72205|La Mesa, California, United States, 91942|Boca Raton, Florida, United States, 33487 Helix Biomedics LlcBoynton Beach, Florida, United States, 33436 Alzheimer'S Research And Treatment CenterLake Worth, Florida, United States, 33449 Meridien Research - Lakeland SiteLakeland, Florida, United States, 33805 Zynak Clinical ServicesLauderdale Lakes, Florida, United States, 33313 Crystal Biomedical Research, LlcMiami Lakes, Florida, United States, 33014 City Medical Group RcMiami, Florida, United States, 33126 Finlay Medical Research CorpMiami, Florida, United States, 33126 Miami Jewish Health Systems, Inc.Miami, Florida, United States, 33137 Clinical Research Associates Of South FloridaMiami, Florida, United States, 33172 Pharmax Research Of South FloridaMiami, Florida, United States, 33175 Research Institute Of West Kendall[Active, Not Recruiting]Miami, Florida, United States, 33186 Bayside Clinical ResearchNew Port Richey, Florida, United States, 34655 Academic Alliance In DermatologyTampa, Florida, United States, 33617|Decatur, Georgia, United States, 30033|Caro, Michigan, United States, 48723|Chesterfield, Missouri, United States, 63005|Toms River, New Jersey, United States, 08755|Orangeburg, New York, United States, 10962|Beachwood, Ohio, United States, 44122|Oklahoma City, Oklahoma, United States, 73102|Norristown, Pennsylvania, United States, 19403|Desoto, Texas, United States, 75115|Bellevue, Washington, United States, 98007","Arizona|Arkansas|California|Florida|Georgia|Michigan|Missouri|New Jersey|New York|Ohio|Oklahoma|Pennsylvania|Texas|Washington","Australia|Bulgaria|Czechia|France|Hungary|Italy|Poland|South Africa|Spain|United Kingdom|United States","Australian Alzheimer's Research Foundation|University Multiprofile Hospital For Active Treatment Dr. Georgi Stranski|Fakultni Nemocnice U Sv. Anny V Brne|Centre Hospitalier Universitaire De Caen - HÃ´pital CÃ´te De Nacre|Dr. Kenessey Albert KÃ³rhÃ¡z-RendelÅ‘intÃ©zet|EgÃ©szsÃ©gÃ¼gyi Ã‰s SzolgÃ¡ltatÃ³ KorlÃ¡tolt FelelÅ‘ssÃ©gÅ± TÃ¡rsasÃ¡g|Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia|ÅšrÃ³dmieÅ›cie Przychodnia - Bydgoszcz|Acf Neurological Services|FundaciÃ³ Ace|Mac Clinical Research - Barnsley|Liv Generations Of Ahwatukee / Cct|Clinical Trials Inc.|Paradigm Clinical Research Centers, Inc.|Sfm Clinical Research, Llc|Neurostudies. Net, Llc|Onyx Clinical Research, Llc|Galen Research|Bio Behavioral Health|Nathan S. Kline Institute For Psychiatric Research|Insight Clinical Trials Llc|Newton Clinical Research|Keystone Clinical Studies, Llc|Insite Clinical Research|Northwest Clinical Research Center",{"$nulls":4},"2020-02-27","2020-05-25T16:35:45.163","2020-05-26T17:10:42.972","NCT03393520"]
["5ecbf3e011702c1b1b9169f7","NCT03393520","2020-04-02","Avanir","AVNR","Recruiting","Assessment of the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type","Avp-786",null,"Yes","['Avp-786']","Unknown",null,"Phase 3",3,412,"Anticipated","2017-10-13","2021-06-01",{"$nulls":5},"This study will be conducted to evaluate the efficacy, safety, and tolerability of AVP-786 compared to placebo, for the treatment of agitation in participants with dementia of the Alzheimer's type.","Eligible participants for this study must have a diagnosis of probable Alzheimer's disease (AD) and must have clinically significant, moderate/severe agitation secondary to AD.\n\nThis is a multicenter, randomized, double-blind, placebo-controlled, parallel-design study, consisting of 12 weeks of treatment.\n\nApproximately 412 participants will be enrolled at approximately 90 centers worldwide.\n\nStudy medication will be administered orally twice-daily from Day 1 through Day 85. Screening will occur within approximately 4 weeks prior to randomization. Following screening procedures for assessment of inclusion and exclusion criteria, eligible participants will be randomized into the study.","A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-design Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type","17-AVP-786-305","Agitation in Patients With Dementia of the Alzheimer's Type","Alzheimer Disease|Dementia","Neurocognitive Disorders","Central Nervous System","Placebo Comparator|Experimental","Placebo|AVP-786; Dose 1|AVP-786; Dose 2","Participants will be assigned to treatment with placebo capsules administered twice a day over a 12-week period.|Participants will receive AVP-786 (Dose 1) capsules administered twice a day over a 12-week period.|Participants will receive AVP-786 (Dose 2) capsules administered twice a day over a 12-week period.","Drug","Placebo|AVP-786","oral capsules",null,"Placebo|AVP-786; Dose 1|AVP-786; Dose 2","\n\n * Diagnosis of probable Alzheimer's Disease (AD) according to the 2011 National Institute on Aging-Alzheimer's Association (NIA-AA) working groups criteria\n * Participants with clinically significant, moderate/severe agitation at the time of screening and for at least 2 weeks prior to randomization that interferes with their daily routine and for which a prescription medication has been indicated, in the opinion of the investigator\n * The diagnosis of agitation must meet the provisional consensus definition of agitation in participants with cognitive disorders developed by the International Psychogeriatric Association (IPA) Agitation Definition Work Group.\n * A Clinical Global Impression of Severity of Illness scale for Agitation (CGIS-Agitation) score of â‰¥ 4 (moderately ill) at screening and baseline\n * Participants must have a reliable caregiver who is able and willing to comply with study procedures, including not administering any prohibited medications during the course of the study.\n * Caregiver who is able and willing to comply with all required study procedures. In order to qualify as a reliable informant (i.e., caregiver) capable of assessing changes in participant's condition during the study, the individual must spend a minimum of 2 hours per day for 4 days per week with the participant.\n\n","\n\n * Participants with dementia predominantly of the non-Alzheimer's type (e.g., vascular dementia, frontotemporal dementia, Parkinson's disease, substance-induced dementia)\n * Participants with symptoms of agitation that are not secondary to AD (e.g., secondary to pain, other psychiatric disorder, or delirium)\n * Participants with co-existent clinically significant or unstable systemic diseases that could confound the interpretation of the safety results of the study (e.g., malignancy, poorly controlled diabetes, poorly controlled hypertension, unstable pulmonary, renal or hepatic disease, unstable ischemic cardiac disease, dilated cardiomyopathy, or unstable valvular heart disease)\n * Participants with myasthenia gravis",{"$nulls":4},"Actual","2018-01-08","Actual","Anticipated","2021-06-01","Anticipated","2020-04-01","2018-01-03","2018-01-03","2020-04-01","Yes","Agitation\nDementia of the Alzheimer's type\nAlzheimer's disease\nAVP-786\nDeudextromethorphan hydrobromide\nQuinidine sulfate","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","50 Years","90 Years","All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"2017-001339-38","EudraCT Number","Change from Baseline to Week 12 in the Cohen-Mansfield Agitation Inventory (CMAI) Composite Score","Baseline; Week 12",null,"Change from Baseline to Week 12 in the Modified Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change for Agitation (mADCS-CGIC-Agitation) Score|Change from Baseline to Week 12 in the Neuropsychiatric Inventory (NPI) Agitation/Aggression Domain Score|Change from Baseline to Week 12 in the NPI Caregiver Distress Score|Change from Baseline to Week 12 in the NPI Aberrant Motor Behavior Domain Score|Change from Baseline to Week 12 in the NPI Irritability/Lability Domain Score|Change from Baseline to Week 12 in the NPI Total Score|Change from Baseline to Week 12 in the Clinical Global Impression of Severity (CGIS)-Agitation Domain Score|Change from Baseline to Week 12 in the ADCS-CGIC for Overall Clinical Status Rating|Change from Baseline to Week 12 in the Patient Global Impression of Change (PGIC) Scale Score|Change from Baseline to Week 12 in the Dementia Quality of Life (DEMQOL) Scale Score|Change from Baseline to Week 12 in EuroQol-5 Dimension-5 Level (EQ-5D-5L) Dimension Scores|Change from Baseline to Week 12 in the Resource Utilization in Dementia (RUD) Scale Score","Baseline; Week 12",{"$nulls":4},"Nedlands, Australia Neuro Trials Victoria Pty LtdNoble Park, Australia The Alfred HospitalParkville, Australia|Pleven, Bulgaria Center For Mental Health - RuseRuse, Bulgaria First Multiprofile Hospital For Active Treatment SofiaSofia, Bulgaria Medical Center StimulSofia, Bulgaria Medical Center Sveti NaumSofia, Bulgaria University Multiprofile Hospital For Active Treatment AlexandrovskaSofia, Bulgaria Medica Plus Medical CenterVeliko Tarnovo, Bulgaria|Brno, Czechia FakultnÃ­ Nemocnice Hradec KrÃ¡lovÃ©Hradec KralovÃ©, Czechia NeuropsychiatriehkHradec KrÃ¡lovÃ©, Czechia Brain-SoultherapyKladno, Czechia SupervizeKutnÃ¡ Hora, Czechia Ad71Praha, Czechia ClintrialPraha, Czechia Neurologicka Ambulance - ForbeliPraha, Czechia NeuropsychiatriePraha, Czechia Vestra ClinicsRychnov Nad KnÄ›Å¾nou, Czechia|Caen Cedex 9, France Centre Hospitalier De CalaisCalais, France Centre Hospitalier Universitaire Dijon BourgognDijon Cedex, France Centre Hospitalier Universitaire De PoitiersPoitiers, France Centre Hospitalier Universitaire De Saint-Ã‰tienne - HÃ´pital NordSaint-Etienne, France Centre Hospitalier Universitaire Toulouse - Casselardit AncelyToulouse, France Centre Hospitalier Universitaire De Nancy - HÃ´pital De BraboisVandoeuvre Les Nancy, France|Balassagyarmat, Hungary Semmelweis EgyetemBudapest, Hungary Szent Janos Korhaz Es Eszak-Budai Egyesitett KorhazakBudapest, Hungary Debreceni Egyetem Kenezy Gyula Egyetemi KorhazDebrecen, Hungary Valeomed Egeszsegugyi Es Szolgaltato KftEsztergom, Hungary Cru|Miskolc, Hungary Szabolcs-Szatmar-Bereg Megyei Korhazak Es Egyetemi OktatokorhazNyiregyhaza, Hungary PsychotechPecs, Hungary Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai KozpontSzeged, Hungary FejÃ©r Megyei Szent GyÃ¶rgy Egyetemi OktatÃ³ KÃ³rhÃ¡zSzÃ©kesfehÃ©rvÃ¡r, Hungary|Brescia, Italy Centro San Giovanni Di Dio - FatebenefratelliBrescia, Italy UniversitÃ  Degli Studi G.D'Annunzio Chieti PescaraChieti, Italy Azienda Ospedaliero - Universitaria CareggiFirenze, Italy Fondazione Irccs Ca' Granda Ospedale Maggiore PoliclinicoMilano, Italy Azienda Ospedaliera San Gerardo Di MonzaMonza, Italy Azienda Sanitaria Locale Di Biella - Nuovo Ospedale Degli InfermiPonderano, Italy Azienda Ospedaliera Sant'AndreaRoma, Italy Fondazione Policlinico Tor VergataRoma, Italy Fondazione Santa Lucia - Istituto Di Ricovero E Cura A Carattere ScientificoRoma, Italy|Bydgoszcz, Poland Centrum Medyczne SensemedChorzÃ³w, Poland Care ClinicKatowice, Poland Wielospecjalistyczna Poradnia Lekarska SynapsisKatowice, Poland Krakowska Akademia NeurologiiKrakÃ³w, Poland Pratia Mcm KrakÃ³wKrakÃ³w, Poland Medycyna MilorzabLodz, Poland Neurologiczny Niepubliczny ZakÅ‚ad Opieki ZdrowotnejPlewiska, Poland Centrum Medyczne HcpPoznaÅ„, Poland Solumed Centrum MedycznePoznaÅ„, Poland Centrum Medyczne EuromedisSzczecin, Poland Centrum Medyczne NeuroprotectWarszawa, Poland Centrum Medyczne Pratia WarszawaWarszawa, Poland|Cape Town, South Africa Cape Trial CentreCape Town, South Africa Flexivest Fourteen Research CentreCape Town, South Africa Apollo Clinical ResearchJohannesburg, South Africa Medical And Dental CentreRosebank, South Africa Dr. Chisto Carel CoetzeeUmhlanga, South Africa|Barcelona, Spain FundaciÃ³ Hospital De La Santa Creu I Sant PauBarcelona, Spain Hospital Clinic De BarcelonaBarcelona, Spain Hospital Universitari Vall D'HebrÃ³nBarcelona, Spain Hospital Universitario Reina SofiaCÃ³rdoba, Spain Hospital General Universitario De ElcheElche, Spain Hospital Universitari De Santa MariaLleida, Spain Hospital General Universitario Gregorio MaraÃ±Ã³nMadrid, Spain Hospital Universitario 12 De OctubreMadrid, Spain Hospital Universitario La PazMadrid, Spain ClÃ­nica Universidad De NavarraPamplona, Spain Hospital Universitario De SalamancaSalamanca, Spain Hospital Universitario MarquÃ©s De ValdecillaSantander, Spain Hospital Universitario Virgen MacarenaSevilla, Spain Hospital Universitario Y PolitÃ©cnico De La FeValencia, Spain Complejo Asistencial De Zamora Hospital Virgen De La ConchaZamora, Spain Hospital Viamed MontecanalZaragoza, Spain|Barnsley, United Kingdom Research Institute For The Care Of Older PeopleBath, United Kingdom Belfast Health And Social Care TrustBelfast, United Kingdom Mac Clinical Research - BlackpoolBlackpool, United Kingdom Mac Clinical Research - CannockCannock, United Kingdom Mac Clinical Research - LeedsLeeds, United Kingdom Re:Cognition Health - LondonLondon, United Kingdom South London And Maudsley Nhs Foundation TrustLondon, United Kingdom Mac Clinical Research - ManchesterManchester, United Kingdom Northamptonshire Healthcare Nhs Foundation TrustNorthampton, United Kingdom Mac Clinical Research - LiverpoolPrescot, United Kingdom Southern Health Nhs Foundation TrustSouthampton, United Kingdom Avon And Wiltshire Mental Health Partnership Nhs TrustSwindon, United Kingdom North West Boroughs Healthcare Nhs Foundation TrustWarrington, United Kingdom|Phoenix, Arizona, United States, 85048 Perseverance Research CenterScottsdale, Arizona, United States, 85254|Little Rock, Arkansas, United States, 72205|La Mesa, California, United States, 91942|Boca Raton, Florida, United States, 33487 Helix Biomedics LlcBoynton Beach, Florida, United States, 33436 Alzheimer'S Research And Treatment CenterLake Worth, Florida, United States, 33449 Meridien Research - Lakeland SiteLakeland, Florida, United States, 33805 Zynak Clinical ServicesLauderdale Lakes, Florida, United States, 33313 Crystal Biomedical Research, LlcMiami Lakes, Florida, United States, 33014 City Medical Group RcMiami, Florida, United States, 33126 Finlay Medical Research CorpMiami, Florida, United States, 33126 Miami Jewish Health Systems, Inc.Miami, Florida, United States, 33137 Clinical Research Associates Of South FloridaMiami, Florida, United States, 33172 Pharmax Research Of South FloridaMiami, Florida, United States, 33175 Research Institute Of West Kendall[Active, Not Recruiting]Miami, Florida, United States, 33186 Bayside Clinical ResearchNew Port Richey, Florida, United States, 34655 Academic Alliance In DermatologyTampa, Florida, United States, 33617|Decatur, Georgia, United States, 30033|Caro, Michigan, United States, 48723|Chesterfield, Missouri, United States, 63005|Toms River, New Jersey, United States, 08755|Orangeburg, New York, United States, 10962|Beachwood, Ohio, United States, 44122|Oklahoma City, Oklahoma, United States, 73102|Norristown, Pennsylvania, United States, 19403|Desoto, Texas, United States, 75115|Bellevue, Washington, United States, 98007","Arizona|Arkansas|California|Florida|Georgia|Michigan|Missouri|New Jersey|New York|Ohio|Oklahoma|Pennsylvania|Texas|Washington","Australia|Bulgaria|Czechia|France|Hungary|Italy|Poland|South Africa|Spain|United Kingdom|United States","Australian Alzheimer's Research Foundation|University Multiprofile Hospital For Active Treatment Dr. Georgi Stranski|Fakultni Nemocnice U Sv. Anny V Brne|Centre Hospitalier Universitaire De Caen - HÃ´pital CÃ´te De Nacre|Dr. Kenessey Albert KÃ³rhÃ¡z-RendelÅ‘intÃ©zet|EgÃ©szsÃ©gÃ¼gyi Ã‰s SzolgÃ¡ltatÃ³ KorlÃ¡tolt FelelÅ‘ssÃ©gÅ± TÃ¡rsasÃ¡g|Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia|ÅšrÃ³dmieÅ›cie Przychodnia - Bydgoszcz|Acf Neurological Services|FundaciÃ³ Ace|Mac Clinical Research - Barnsley|Liv Generations Of Ahwatukee / Cct|Clinical Trials Inc.|Paradigm Clinical Research Centers, Inc.|Sfm Clinical Research, Llc|Neurostudies. Net, Llc|Onyx Clinical Research, Llc|Galen Research|Bio Behavioral Health|Nathan S. Kline Institute For Psychiatric Research|Insight Clinical Trials Llc|Newton Clinical Research|Keystone Clinical Studies, Llc|Insite Clinical Research|Northwest Clinical Research Center",{"$nulls":4},"2020-04-01","2020-05-25T16:35:44.926","2020-05-26T17:10:42.972","NCT03393520"]
["5ecbf3e0307e3d1b1f8d9c75","NCT03393520","2020-04-29","Avanir","AVNR","Active, not recruiting","Assessment of the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type","Avp-786",null,"Yes","['Avp-786']","Unknown",null,"Phase 3",3,412,"Anticipated","2017-10-13","2021-06-01",{"$nulls":5},"This study will be conducted to evaluate the efficacy, safety, and tolerability of AVP-786 compared to placebo, for the treatment of agitation in participants with dementia of the Alzheimer's type.","Eligible participants for this study must have a diagnosis of probable Alzheimer's disease (AD) and must have clinically significant, moderate/severe agitation secondary to AD.\n\nThis is a multicenter, randomized, double-blind, placebo-controlled, parallel-design study, consisting of 12 weeks of treatment.\n\nApproximately 412 participants will be enrolled at approximately 90 centers worldwide.\n\nStudy medication will be administered orally twice-daily from Day 1 through Day 85. Screening will occur within approximately 4 weeks prior to randomization. Following screening procedures for assessment of inclusion and exclusion criteria, eligible participants will be randomized into the study.\n\nScreening and enrollment pause due to COVID-19 pandemic","A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-design Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type","17-AVP-786-305","Agitation in Patients With Dementia of the Alzheimer's Type","Alzheimer Disease|Dementia","Neurocognitive Disorders","Central Nervous System","Placebo Comparator|Experimental","Placebo|AVP-786; Dose 1|AVP-786; Dose 2","Participants will be assigned to treatment with placebo capsules administered twice a day over a 12-week period.|Participants will receive AVP-786 (Dose 1) capsules administered twice a day over a 12-week period.|Participants will receive AVP-786 (Dose 2) capsules administered twice a day over a 12-week period.","Drug","Placebo|AVP-786","oral capsules",null,"Placebo|AVP-786; Dose 1|AVP-786; Dose 2","\n\n * Diagnosis of probable Alzheimer's Disease (AD) according to the 2011 National Institute on Aging-Alzheimer's Association (NIA-AA) working groups criteria\n * Participants with clinically significant, moderate/severe agitation at the time of screening and for at least 2 weeks prior to randomization that interferes with their daily routine and for which a prescription medication has been indicated, in the opinion of the investigator\n * The diagnosis of agitation must meet the provisional consensus definition of agitation in participants with cognitive disorders developed by the International Psychogeriatric Association (IPA) Agitation Definition Work Group.\n * A Clinical Global Impression of Severity of Illness scale for Agitation (CGIS-Agitation) score of â‰¥ 4 (moderately ill) at screening and baseline\n * Participants must have a reliable caregiver who is able and willing to comply with study procedures, including not administering any prohibited medications during the course of the study.\n * Caregiver who is able and willing to comply with all required study procedures. In order to qualify as a reliable informant (i.e., caregiver) capable of assessing changes in participant's condition during the study, the individual must spend a minimum of 2 hours per day for 4 days per week with the participant.\n\n","\n\n * Participants with dementia predominantly of the non-Alzheimer's type (e.g., vascular dementia, frontotemporal dementia, Parkinson's disease, substance-induced dementia)\n * Participants with symptoms of agitation that are not secondary to AD (e.g., secondary to pain, other psychiatric disorder, or delirium)\n * Participants with co-existent clinically significant or unstable systemic diseases that could confound the interpretation of the safety results of the study (e.g., malignancy, poorly controlled diabetes, poorly controlled hypertension, unstable pulmonary, renal or hepatic disease, unstable ischemic cardiac disease, dilated cardiomyopathy, or unstable valvular heart disease)\n * Participants with myasthenia gravis",{"$nulls":4},"Actual","2018-01-08","Actual","Anticipated","2021-06-01","Anticipated","2020-04-01","2018-01-03","2018-01-03","2020-04-27","Yes","Agitation\nDementia of the Alzheimer's type\nAlzheimer's disease\nAVP-786\nDeudextromethorphan hydrobromide\nQuinidine sulfate","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","50 Years","90 Years","All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"2017-001339-38","EudraCT Number","Change from Baseline to Week 12 in the Cohen-Mansfield Agitation Inventory (CMAI) Composite Score","Baseline; Week 12",null,"Change from Baseline to Week 12 in the Modified Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change for Agitation (mADCS-CGIC-Agitation) Score|Change from Baseline to Week 12 in the Neuropsychiatric Inventory (NPI) Agitation/Aggression Domain Score|Change from Baseline to Week 12 in the NPI Caregiver Distress Score|Change from Baseline to Week 12 in the NPI Aberrant Motor Behavior Domain Score|Change from Baseline to Week 12 in the NPI Irritability/Lability Domain Score|Change from Baseline to Week 12 in the NPI Total Score|Change from Baseline to Week 12 in the Clinical Global Impression of Severity (CGIS)-Agitation Domain Score|Change from Baseline to Week 12 in the ADCS-CGIC for Overall Clinical Status Rating|Change from Baseline to Week 12 in the Patient Global Impression of Change (PGIC) Scale Score|Change from Baseline to Week 12 in the Dementia Quality of Life (DEMQOL) Scale Score|Change from Baseline to Week 12 in EuroQol-5 Dimension-5 Level (EQ-5D-5L) Dimension Scores|Change from Baseline to Week 12 in the Resource Utilization in Dementia (RUD) Scale Score","Baseline; Week 12",{"$nulls":4},"Nedlands, Australia Neuro Trials Victoria Pty LtdNoble Park, Australia The Alfred HospitalParkville, Australia|Pleven, Bulgaria Center For Mental Health - RuseRuse, Bulgaria First Multiprofile Hospital For Active Treatment SofiaSofia, Bulgaria Medical Center StimulSofia, Bulgaria Medical Center Sveti NaumSofia, Bulgaria University Multiprofile Hospital For Active Treatment AlexandrovskaSofia, Bulgaria Medica Plus Medical CenterVeliko Tarnovo, Bulgaria|Brno, Czechia FakultnÃ­ Nemocnice Hradec KrÃ¡lovÃ©Hradec KralovÃ©, Czechia NeuropsychiatriehkHradec KrÃ¡lovÃ©, Czechia Brain-SoultherapyKladno, Czechia SupervizeKutnÃ¡ Hora, Czechia Ad71Praha, Czechia ClintrialPraha, Czechia Neurologicka Ambulance - ForbeliPraha, Czechia NeuropsychiatriePraha, Czechia Vestra ClinicsRychnov Nad KnÄ›Å¾nou, Czechia|Caen Cedex 9, France Centre Hospitalier De CalaisCalais, France Centre Hospitalier Universitaire Dijon BourgognDijon Cedex, France Centre Hospitalier Universitaire De PoitiersPoitiers, France Centre Hospitalier Universitaire De Saint-Ã‰tienne - HÃ´pital NordSaint-Etienne, France Centre Hospitalier Universitaire Toulouse - Casselardit AncelyToulouse, France Centre Hospitalier Universitaire De Nancy - HÃ´pital De BraboisVandoeuvre Les Nancy, France|Balassagyarmat, Hungary Semmelweis EgyetemBudapest, Hungary Szent Janos Korhaz Es Eszak-Budai Egyesitett KorhazakBudapest, Hungary Debreceni Egyetem Kenezy Gyula Egyetemi KorhazDebrecen, Hungary Valeomed Egeszsegugyi Es Szolgaltato KftEsztergom, Hungary Cru|Miskolc, Hungary Szabolcs-Szatmar-Bereg Megyei Korhazak Es Egyetemi OktatokorhazNyiregyhaza, Hungary PsychotechPecs, Hungary Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai KozpontSzeged, Hungary FejÃ©r Megyei Szent GyÃ¶rgy Egyetemi OktatÃ³ KÃ³rhÃ¡zSzÃ©kesfehÃ©rvÃ¡r, Hungary|Brescia, Italy Centro San Giovanni Di Dio - FatebenefratelliBrescia, Italy UniversitÃ  Degli Studi G.D'Annunzio Chieti PescaraChieti, Italy Azienda Ospedaliero - Universitaria CareggiFirenze, Italy Fondazione Irccs Ca' Granda Ospedale Maggiore PoliclinicoMilano, Italy Azienda Ospedaliera San Gerardo Di MonzaMonza, Italy Azienda Sanitaria Locale Di Biella - Nuovo Ospedale Degli InfermiPonderano, Italy Azienda Ospedaliera Sant'AndreaRoma, Italy Fondazione Policlinico Tor VergataRoma, Italy Fondazione Santa Lucia - Istituto Di Ricovero E Cura A Carattere ScientificoRoma, Italy|Bydgoszcz, Poland Centrum Medyczne SensemedChorzÃ³w, Poland Care ClinicKatowice, Poland Wielospecjalistyczna Poradnia Lekarska SynapsisKatowice, Poland Krakowska Akademia NeurologiiKrakÃ³w, Poland Pratia Mcm KrakÃ³wKrakÃ³w, Poland Medycyna MilorzabLodz, Poland Neurologiczny Niepubliczny ZakÅ‚ad Opieki ZdrowotnejPlewiska, Poland Centrum Medyczne HcpPoznaÅ„, Poland Solumed Centrum MedycznePoznaÅ„, Poland Centrum Medyczne EuromedisSzczecin, Poland Centrum Medyczne NeuroprotectWarszawa, Poland Centrum Medyczne Pratia WarszawaWarszawa, Poland|Cape Town, South Africa Cape Trial CentreCape Town, South Africa Flexivest Fourteen Research CentreCape Town, South Africa Apollo Clinical ResearchJohannesburg, South Africa Medical And Dental CentreRosebank, South Africa Dr. Chisto Carel CoetzeeUmhlanga, South Africa|Barcelona, Spain FundaciÃ³ Hospital De La Santa Creu I Sant PauBarcelona, Spain Hospital Clinic De BarcelonaBarcelona, Spain Hospital Universitari Vall D'HebrÃ³nBarcelona, Spain Hospital Universitario Reina SofiaCÃ³rdoba, Spain Hospital General Universitario De ElcheElche, Spain Hospital Universitari De Santa MariaLleida, Spain Hospital General Universitario Gregorio MaraÃ±Ã³nMadrid, Spain Hospital Universitario 12 De OctubreMadrid, Spain Hospital Universitario La PazMadrid, Spain ClÃ­nica Universidad De NavarraPamplona, Spain Hospital Universitario De SalamancaSalamanca, Spain Hospital Universitario MarquÃ©s De ValdecillaSantander, Spain Hospital Universitario Virgen MacarenaSevilla, Spain Hospital Universitario Y PolitÃ©cnico De La FeValencia, Spain Complejo Asistencial De Zamora Hospital Virgen De La ConchaZamora, Spain Hospital Viamed MontecanalZaragoza, Spain|Barnsley, United Kingdom Research Institute For The Care Of Older PeopleBath, United Kingdom Belfast Health And Social Care TrustBelfast, United Kingdom Mac Clinical Research - BlackpoolBlackpool, United Kingdom Mac Clinical Research - CannockCannock, United Kingdom Mac Clinical Research - LeedsLeeds, United Kingdom Re:Cognition Health - LondonLondon, United Kingdom South London And Maudsley Nhs Foundation TrustLondon, United Kingdom Mac Clinical Research - ManchesterManchester, United Kingdom Northamptonshire Healthcare Nhs Foundation TrustNorthampton, United Kingdom Mac Clinical Research - LiverpoolPrescot, United Kingdom Southern Health Nhs Foundation TrustSouthampton, United Kingdom Avon And Wiltshire Mental Health Partnership Nhs TrustSwindon, United Kingdom North West Boroughs Healthcare Nhs Foundation TrustWarrington, United Kingdom|Phoenix, Arizona, United States, 85048 Perseverance Research CenterScottsdale, Arizona, United States, 85254|Little Rock, Arkansas, United States, 72205|La Mesa, California, United States, 91942|Boca Raton, Florida, United States, 33487 Helix Biomedics LlcBoynton Beach, Florida, United States, 33436 Alzheimer'S Research And Treatment CenterLake Worth, Florida, United States, 33449 Meridien Research - Lakeland SiteLakeland, Florida, United States, 33805 Zynak Clinical ServicesLauderdale Lakes, Florida, United States, 33313 Crystal Biomedical Research, LlcMiami Lakes, Florida, United States, 33014 City Medical Group RcMiami, Florida, United States, 33126 Finlay Medical Research CorpMiami, Florida, United States, 33126 Miami Jewish Health Systems, Inc.Miami, Florida, United States, 33137 Clinical Research Associates Of South FloridaMiami, Florida, United States, 33172 Pharmax Research Of South FloridaMiami, Florida, United States, 33175 Research Institute Of West KendallMiami, Florida, United States, 33186 Bayside Clinical ResearchNew Port Richey, Florida, United States, 34655 Academic Alliance In DermatologyTampa, Florida, United States, 33617|Decatur, Georgia, United States, 30033|Caro, Michigan, United States, 48723|Chesterfield, Missouri, United States, 63005|Toms River, New Jersey, United States, 08755|Orangeburg, New York, United States, 10962|Beachwood, Ohio, United States, 44122|Oklahoma City, Oklahoma, United States, 73102|Norristown, Pennsylvania, United States, 19403|Desoto, Texas, United States, 75115|Bellevue, Washington, United States, 98007","Arizona|Arkansas|California|Florida|Georgia|Michigan|Missouri|New Jersey|New York|Ohio|Oklahoma|Pennsylvania|Texas|Washington","Australia|Bulgaria|Czechia|France|Hungary|Italy|Poland|South Africa|Spain|United Kingdom|United States","Australian Alzheimer's Research Foundation|University Multiprofile Hospital For Active Treatment Dr. Georgi Stranski|Fakultni Nemocnice U Sv. Anny V Brne|Centre Hospitalier Universitaire De Caen - HÃ´pital CÃ´te De Nacre|Dr. Kenessey Albert KÃ³rhÃ¡z-RendelÅ‘intÃ©zet|EgÃ©szsÃ©gÃ¼gyi Ã‰s SzolgÃ¡ltatÃ³ KorlÃ¡tolt FelelÅ‘ssÃ©gÅ± TÃ¡rsasÃ¡g|Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia|ÅšrÃ³dmieÅ›cie Przychodnia - Bydgoszcz|Acf Neurological Services|FundaciÃ³ Ace|Mac Clinical Research - Barnsley|Liv Generations Of Ahwatukee / Cct|Clinical Trials Inc.|Paradigm Clinical Research Centers, Inc.|Sfm Clinical Research, Llc|Neurostudies. Net, Llc|Onyx Clinical Research, Llc|Galen Research|Bio Behavioral Health|Nathan S. Kline Institute For Psychiatric Research|Insight Clinical Trials Llc|Newton Clinical Research|Keystone Clinical Studies, Llc|Insite Clinical Research|Northwest Clinical Research Center",{"$nulls":4},"2020-04-27","2020-05-25T16:35:44.657","2020-05-26T17:10:42.972","NCT03393520"]
["5ecbf3e5fe30261b1a0481ea","NCT03393806","2018-01-09","GlaxoSmithKline","GSK","Not yet recruiting","Repeat Dose Study of GSK3772847 in Participants With Moderate to Severe Asthma With Allergic Fungal Airway Disease (AFAD)","Gsk-3772847",null,"Yes","['Gsk-3772847']","Unknown",null,"Phase 2",2,46,"Anticipated","2018-02-23","2019-02-13",{"$nulls":5},"This study is multicenter, double-blinded parallel group design, where participants with moderate to severe asthma with AFAD will be enrolled. Participants will receive three doses of 10 milligrams/kilogram (mg/kg) of GSK3772847 every 4 Weeks versus placebo along with standard of care. Participants will be randomized in 1:1 ratio to receive either 10 mg/kg GSK3772847 intravenously (IV) or matching placebo IV. Participants will receive study treatment on Week 0 (Day 1), Week 4 and Week 8. The total duration of the study will be 28 Weeks and approximately 46 participants will be randomized.",null,"A Double Blind (Sponsor Open) Placebo-controlled, Stratified, Parallel Group Study to Evaluate the Efficacy and Safety of Repeat Doses of GSK3772847 in Participants With Moderate to Severe Asthma With Allergic Fungal Airway Disease (AFAD)",207972,"Asthma","Asthma","Bronchial Diseases","Respiratory","Experimental|Placebo Comparator","Participants receiving GSK3772847|Participants receiving placebo","Participants will be randomized to receive GSK3772847 as IV infusion. Participants will receive three doses ( Day 1, Day 29 and Day 57) of GSK3772847 every 4 weeks|Participants will be randomized to receive matching placebo as IV infusion","Drug","GSK3772847|Placebo","GSK3772847 will be available as 100 mg/vial, white to yellow, uniform lyophilized cake in a 5 milliliter (mL) clear glass vial with closure sealed by red metal and yellow overseal.|Commercially sourced sterile normal saline will be provided as Placebo",null,"Participants receiving GSK3772847|Participants receiving placebo","\n\n * Participant must be at least 18 years of age inclusive, at the time of signing the informed consent.\n * Documented history of physician diagnosed moderate or severe asthma for >=12 months based on Guidelines and treated with inhaled corticosteroid (ICS) and long-acting beta-2-agonist (LABA) for at least 4 months (>=500 micrograms/day [Âµg/day]) fluticasone propionate or equivalent as defined in the guidelines.\n * Pre-bronchodilator FEV1 35-79% of predicted value for participant inclusive\n * FeNO >= 25 parts per billion (ppb) at Screening\n * ACQ-5 score >= 1.5 at Screening\n * Blood eosinophil >=300 cells/microliter at Screening\n * Evidence of allergic fungal airway disease like Fungal sensitization to any of the fungi Aspergillus fumigatus, Penicillium chrysogenum (notatum) at screening measured by serum-specific Immunoglobulin (Ig) E test. A history of exacerbations with at least 1 severe exacerbation (defined as requiring a minimum of 3 days of high-dose oral corticosteroids for asthma symptoms) in the previous 12 months.\n * Body weight within 50-150 kilogram (kg)\n * Both male and female gender. A female participant is eligible to participate if she is not pregnant not breastfeeding, Not a woman of childbearing potential (WOCBP) or A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 16 weeks after the last dose of study treatment.\n * Capable of giving signed informed consent\n\n","\n\n * Historical diagnosis of cystic fibrosis\n * Concurrent respiratory diseases: Presence of a known pre-existing, clinically important respiratory conditions (example pneumonia, pneumothorax, atelectasis segmental or larger, pulmonary fibrotic disease, bronchopulmonary dysplasia, chronic bronchitis, emphysema, chronic obstructive pulmonary disease, or other respiratory abnormalities) other than asthma or AFAD\n * Has a history of chronic or recurrent non-pulmonary infectious disease or ongoing non-pulmonary infection including, but not limited to, chronic renal infection, chronic chest infection, recurrent urinary tract infection (example, recurrent pyelonephritis, chronic non-remitting cystitis), or open, draining skin wound or an ulcer\n * Serious infection within 8 weeks of enrolment, including, but not limited to hepatitis, pneumonia, sepsis, or pyelonephritis; or has been hospitalized for an infection; or has been treated with IV antibiotics for an infection, within 8 weeks prior to the first administration of study drug.\n * Evidence of poorly controlled chronic medical conditions other than asthma, example, participants with known, pre-existing, clinically significant endocrine, autoimmune, metabolic, neurological, renal, cardiovascular, gastrointestinal, hepatic, and hematological or any other system abnormalities that are uncontrolled with standard treatment.\n * Cardiovascular disease: Clinically significant organic heart disease\n * Participants with a diagnosis of malignancy or in the process of investigation for a malignancy. Participants with carcinoma that have not been in complete remission for at least 5 years. Participants who have had carcinoma in situ of the cervix, squamous cell carcinoma and basal cell carcinoma of the skin would not be excluded based on the 5 year waiting period if the participant has been considered cured by treatment.\n * Eosinophilic diseases: Other conditions that could lead to elevated eosinophil such as hyper-eosinophilic syndromes. Participants with a known, pre-existing parasitic infestation within 6 months prior to Screening (Visit 1)\n * Prohibited medications is not permitted within the defined time intervals prior to Screening (Visit 1) and throughout the study.\n * Presence of hepatitis B surface antigen (HBsAg), positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study treatment.\n * A known immunodeficiency such as human immunodeficiency virus infection.\n * Hypersensitivity: significant allergies to humanized monoclonal antibodies or biologic or to any components of the formulation used in this study\n * Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear Ig A dermatosis, toxic epidermal necrolysis, and exfoliative dermatitis).\n * Clinically significant abnormality on 12-lead ECG assessment at screening (Visit 1). Site investigators will be provided with ECG over-read conducted by a centralized independent cardiologist, to assist in evaluation of participant eligibility.\n * Sinus bradycardia <45 beats per minute (bpm), sinus tachycardia >= 110 bpm, multifocal atrial tachycardia (wandering atrial pacemaker with rate >100bpm), evidence of Mobitz II second degree or third degree atrioventricular (AV) block, pathological Q waves (defined as wide [>0.04 seconds] and deep [>0.4 millivolts (mV) (4 millimeter [mm] with 10mm/mV setting)] or >25% of the height of the corresponding R wave, providing the R wave was >0.5mV [5mm with 10mm/mV setting], appearing in at least two contiguous leads, evidence of ventricular ectopic couplets, bigeminy, trigeminy or multifocal premature ventricular complexes, for participants without complete right bundle branch block: QTc for heart rate by Fridericia's formula QTc(F) >= 450 millisecond (msec) or an ECG that is unsuitable for QT measurements, for participants with complete right bundle branch block: QTc(F) >=480 msec or an ECG that is unsuitable for QT measurements, ST-T wave abnormalities, clinically significant conduction abnormalities and clinically significant arrhythmias.\n * Smoking history: current smokers or former smokers with a smoking history >= 10 pack years\n * History of alcohol or illegal substance abuse within 2 years prior to Screening (Visit1).\n * Participants at risk of non-compliance, or unable to comply with the study procedures. Participants who are unable to follow study instructions such as visit schedule and paper diary completion. Participants who have known evidence of lack of adherence to controller medication and/or ability to follow physician's recommendations. Any infirmity, disability, or geographic location that would limit compliance for scheduled visits.",{"$nulls":4},"Actual","2018-01-09","Actual","Anticipated","2019-05-08","Anticipated","2018-01-01","2018-01-03","2018-01-03","2018-01-03","No","Asthma Control Questionnaire\nAllergic fungal airway disease\nAsthma Quality of Life Questionnaire\nHolter monitoring\nAsthma","Interventional","Treatment","Parallel Assignment","Double (Participant, Investigator)","Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":4},"No",{"$nulls":14},"Change from Baseline in blood eosinophils|Change from Baseline in fractional exhaled nitric oxide (FeNO)","Blood samples will be collected at indicated time points for the assessment of eosinophil|FeNO will be measured using a handheld electronic device","Baseline and up to Day 88","Serum concentrations of GSK3772847|Serum levels of free soluble suppressor of tumorigenicity 2 (ST2)|Serum levels of total soluble ST2|Number of participants with positive result of serum anti-GSK3772847 antibodies post dosing|Titers of serum anti-GSK3772847 antibodies post dosing|Change from Baseline in Asthma Control Questionnaire-5 (ACQ-5) absolute score at Weeks 2, 4, 8 and 12|Change from Baseline in Asthma Quality of Life Questionnaire (AQLQ) total and domain scores at Weeks 2, 4, 8 and 12|Number of responders to ACQ-5|Number of responders to AQLQ|Change from Baseline in forced expiratory volume in 1 second (FEV1)|Change from Baseline in forced vital capacity (FVC)|Number of participants with treatment emergent adverse events (AE) and serious AEs (SAE)|Number of participants with abnormal hematology parameters|Number of participants with abnormal clinical chemistry parameters|Number of participants with abnormal systolic blood pressure (SBP) and diastolic blood pressure (DBP)|Number of participants with abnormal heart rate|Number of participants with abnormal findings in Electrocardiogram (ECG)|Number of participants with abnormal 24-hour Holter findings","Blood samples will be collected at indicated time points for assessment of serum concentrations|Blood samples will be collected at indicated time points to measure free soluble ST2|Blood samples will be collected at indicated time points to measure total soluble ST2|Blood samples will be collected at indicated time points and anti-GSK3772847 antibodies will be assessed using a tiered approach.|ACQ-5 is a 5-item questionnaire that is a measure of the participant's asthma control. The five questions include about the frequency and/or severity of symptoms like nocturnal awakening, activity limitation, shortness of breath and wheeze. The score scales from zero (totally controlled) and 6 (severely uncontrolled)|AQLQ is 32 items four domains questionnaire used for evaluation of impact of asthma treatments on the quality of life of participants. The scores are evaluated from 1 (total impairment) and 7 (no impairment)|ACQ-5 is a 5 question tool used to measure attributes of asthma control and the score ranges from 0 to 6 where 0 is no impairment/limitation and 6 is total impairment/limitation. A responder to ACQ-5 will be defined as a participant who has a decrease from Baseline in ACQ-5 score of 0.5 or more.|AQLQ is a 32 items four domain questionnaire used to measure quality of life participants due to asthma treatment and the scores ranges from 1 to 7 where 1 indicates total impairment and 7 indicates no impairment. A responder to AQLQ will be defined as a participant who has an increase from Baseline in AQLQ score of 0.5 or more.|Spirometry assessment will include pre-bronchodilator FEV1|Spirometry assessment will include pre-bronchodilator FVC|An AE is any untoward medical occurrence in a clinical study participants, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that, at any dose may result in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment.|Laboratory assessment for hematology parameters will include Platelet count, hemoglobin, Red blood cell (RBC) count, hematocrit, Red blood cell distribution width (RDW), RBC indices like mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH) and mean corpuscular hemoglobin concentration (MCHC). White blood cell (WBC) count with differential will include neutrophils, lymphocytes, monocytes, eosinophils and basophils.|Laboratory assessment for clinical chemistry parameters will include blood urea nitrogen (BUN), potassium, calcium, sodium, creatinine, non-fasting glucose, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline phosphate, Gamma-glutamyl transferase (GGT), albumin, phosphorus, carbon dioxide, total protein, creatine phosphokinase (CPK), total and direct bilirubin|Blood pressure will be measured in supine position after 5 minutes rest|Heart rate will be measured in supine position after 5 minutes rest|Single 12-lead ECG will be obtained using an ECG machine that automatically measures heart rate, PR, QRS, QT, and QT interval corrected for heart rate (QTc) and ventricular rate|Holter assessment will be used for quantitative assessment of abnormal rhythm events. Holter monitor will be placed 30-60 minutes prior to dosing.","Day 1 post-end of infusion, Day 15, Pre-dose on Day 29, Pre-dose and post-dose on Day 57, Day 85 and Day 169|Day 1 Pre and post-dose; Day 15; Day 29 Post dose; Day 57 pre and post dose; Day 85, Day 169|Up to Day 172|Baseline and at Weeks 2, 4, 8 and 12|Up to Day 88|Day 1","GSKClinicalSupportHD@gsk.com","US GSK Clinical Trials Call Center","877-379-3718",{"$nulls":7},"GSK Clinical Trials","2018-01-03","2020-05-25T16:35:49.089","2020-05-26T17:10:42.972","NCT03393806"]
["5ecbf3e4feab101b15530819","NCT03393806","2018-02-05","GlaxoSmithKline","GSK","Not yet recruiting","Repeat Dose Study of GSK3772847 in Participants With Moderate to Severe Asthma With Allergic Fungal Airway Disease (AFAD)","Gsk-3772847",null,"Yes","['Gsk-3772847']","Unknown",null,"Phase 2",2,46,"Anticipated","2018-03-14","2019-04-09",{"$nulls":5},"This study is multicenter, double-blinded parallel group design, where participants with moderate to severe asthma with AFAD will be enrolled. Participants will receive three doses of 10 milligrams/kilogram (mg/kg) of GSK3772847 every 4 Weeks versus placebo along with standard of care. Participants will be randomized in 1:1 ratio to receive either 10 mg/kg GSK3772847 intravenously (IV) or matching placebo IV. Participants will receive study treatment on Week 0 (Day 1), Week 4 and Week 8. The total duration of the study will be 28 Weeks and approximately 46 participants will be randomized.",null,"A Double Blind (Sponsor Open) Placebo-controlled, Stratified, Parallel Group Study to Evaluate the Efficacy and Safety of Repeat Doses of GSK3772847 in Participants With Moderate to Severe Asthma With Allergic Fungal Airway Disease (AFAD)",207972,"Asthma","Asthma","Bronchial Diseases","Respiratory","Experimental|Placebo Comparator","Participants receiving GSK3772847|Participants receiving placebo","Participants will be randomized to receive GSK3772847 as IV infusion. Participants will receive three doses ( Day 1, Day 29 and Day 57) of GSK3772847 every 4 weeks|Participants will be randomized to receive matching placebo as IV infusion","Drug","GSK3772847|Placebo","GSK3772847 will be available as 100 mg/vial, white to yellow, uniform lyophilized cake in a 5 milliliter (mL) clear glass vial with closure sealed by red metal and yellow overseal.|Commercially sourced sterile normal saline will be provided as Placebo",null,"Participants receiving GSK3772847|Participants receiving placebo","\n\n * Participant must be at least 18 years of age inclusive, at the time of signing the informed consent.\n * Documented history of physician diagnosed moderate or severe asthma for >=12 months based on Guidelines and treated with inhaled corticosteroid (ICS) and long-acting beta-2-agonist (LABA) for at least 4 months (>=500 micrograms/day [Âµg/day]) fluticasone propionate or equivalent as defined in the guidelines.\n * Pre-bronchodilator FEV1 35-79% of predicted value for participant inclusive\n * FeNO >= 25 parts per billion (ppb) at Screening\n * ACQ-5 score >= 1.5 at Screening\n * Blood eosinophil >=300 cells/microliter at Screening\n * Evidence of allergic fungal airway disease like Fungal sensitization to any of the fungi Aspergillus fumigatus, Penicillium chrysogenum (notatum) at screening measured by serum-specific Immunoglobulin (Ig) E test. A history of exacerbations with at least 1 severe exacerbation (defined as requiring a minimum of 3 days of high-dose oral corticosteroids for asthma symptoms) in the previous 12 months.\n * Body weight within 50-150 kilogram (kg)\n * Both male and female gender. A female participant is eligible to participate if she is not pregnant not breastfeeding, Not a woman of childbearing potential (WOCBP) or A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 16 weeks after the last dose of study treatment.\n * Capable of giving signed informed consent\n\n","\n\n * Historical diagnosis of cystic fibrosis\n * Concurrent respiratory diseases: Presence of a known pre-existing, clinically important respiratory conditions (example pneumonia, pneumothorax, atelectasis segmental or larger, pulmonary fibrotic disease, bronchopulmonary dysplasia, chronic bronchitis, emphysema, chronic obstructive pulmonary disease, or other respiratory abnormalities) other than asthma or AFAD\n * Has a history of chronic or recurrent non-pulmonary infectious disease or ongoing non-pulmonary infection including, but not limited to, chronic renal infection, chronic chest infection, recurrent urinary tract infection (example, recurrent pyelonephritis, chronic non-remitting cystitis), or open, draining skin wound or an ulcer\n * Serious infection within 8 weeks of enrolment, including, but not limited to hepatitis, pneumonia, sepsis, or pyelonephritis; or has been hospitalized for an infection; or has been treated with IV antibiotics for an infection, within 8 weeks prior to the first administration of study drug.\n * Evidence of poorly controlled chronic medical conditions other than asthma, example, participants with known, pre-existing, clinically significant endocrine, autoimmune, metabolic, neurological, renal, cardiovascular, gastrointestinal, hepatic, and hematological or any other system abnormalities that are uncontrolled with standard treatment.\n * Cardiovascular disease: Clinically significant organic heart disease\n * Participants with a diagnosis of malignancy or in the process of investigation for a malignancy. Participants with carcinoma that have not been in complete remission for at least 5 years. Participants who have had carcinoma in situ of the cervix, squamous cell carcinoma and basal cell carcinoma of the skin would not be excluded based on the 5 year waiting period if the participant has been considered cured by treatment.\n * Eosinophilic diseases: Other conditions that could lead to elevated eosinophil such as hyper-eosinophilic syndromes. Participants with a known, pre-existing parasitic infestation within 6 months prior to Screening (Visit 1)\n * Prohibited medications is not permitted within the defined time intervals prior to Screening (Visit 1) and throughout the study.\n * Presence of hepatitis B surface antigen (HBsAg), positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study treatment.\n * A known immunodeficiency such as human immunodeficiency virus infection.\n * Hypersensitivity: significant allergies to humanized monoclonal antibodies or biologic or to any components of the formulation used in this study\n * Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear Ig A dermatosis, toxic epidermal necrolysis, and exfoliative dermatitis).\n * Clinically significant abnormality on 12-lead ECG assessment at screening (Visit 1). Site investigators will be provided with ECG over-read conducted by a centralized independent cardiologist, to assist in evaluation of participant eligibility.\n * Sinus bradycardia <45 beats per minute (bpm), sinus tachycardia >= 110 bpm, multifocal atrial tachycardia (wandering atrial pacemaker with rate >100bpm), evidence of Mobitz II second degree or third degree atrioventricular (AV) block, pathological Q waves (defined as wide [>0.04 seconds] and deep [>0.4 millivolts (mV) (4 millimeter [mm] with 10mm/mV setting)] or >25% of the height of the corresponding R wave, providing the R wave was >0.5mV [5mm with 10mm/mV setting], appearing in at least two contiguous leads, evidence of ventricular ectopic couplets, bigeminy, trigeminy or multifocal premature ventricular complexes, for participants without complete right bundle branch block: QTc for heart rate by Fridericia's formula QTc(F) >= 450 millisecond (msec) or an ECG that is unsuitable for QT measurements, for participants with complete right bundle branch block: QTc(F) >=480 msec or an ECG that is unsuitable for QT measurements, ST-T wave abnormalities, clinically significant conduction abnormalities and clinically significant arrhythmias.\n * Smoking history: current smokers or former smokers with a smoking history >= 10 pack years\n * History of alcohol or illegal substance abuse within 2 years prior to Screening (Visit1).\n * Participants at risk of non-compliance, or unable to comply with the study procedures. Participants who are unable to follow study instructions such as visit schedule and paper diary completion. Participants who have known evidence of lack of adherence to controller medication and/or ability to follow physician's recommendations. Any infirmity, disability, or geographic location that would limit compliance for scheduled visits.",{"$nulls":4},"Actual","2018-01-09","Actual","Anticipated","2019-07-02","Anticipated","2018-02-01","2018-01-03","2018-01-03","2018-02-02","No","Asthma Control Questionnaire\nAllergic fungal airway disease\nAsthma Quality of Life Questionnaire\nHolter monitoring\nAsthma","Interventional","Treatment","Parallel Assignment","Double (Participant, Investigator)","Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":4},"No",{"$nulls":14},"Change from Baseline in blood eosinophils|Change from Baseline in fractional exhaled nitric oxide (FeNO)","Blood samples will be collected at indicated time points for the assessment of eosinophil|FeNO will be measured using a handheld electronic device","Baseline and up to Day 88","Serum concentrations of GSK3772847|Serum levels of free soluble suppressor of tumorigenicity 2 (ST2)|Serum levels of total soluble ST2|Number of participants with positive result of serum anti-GSK3772847 antibodies post dosing|Titers of serum anti-GSK3772847 antibodies post dosing|Change from Baseline in Asthma Control Questionnaire-5 (ACQ-5) absolute score at Weeks 2, 4, 8 and 12|Change from Baseline in Asthma Quality of Life Questionnaire (AQLQ) total and domain scores at Weeks 2, 4, 8 and 12|Number of responders to ACQ-5|Number of responders to AQLQ|Change from Baseline in forced expiratory volume in 1 second (FEV1)|Change from Baseline in forced vital capacity (FVC)|Number of participants with treatment emergent adverse events (AE) and serious AEs (SAE)|Number of participants with abnormal hematology parameters|Number of participants with abnormal clinical chemistry parameters|Number of participants with abnormal systolic blood pressure (SBP) and diastolic blood pressure (DBP)|Number of participants with abnormal heart rate|Number of participants with abnormal findings in Electrocardiogram (ECG)|Number of participants with abnormal 24-hour Holter findings","Blood samples will be collected at indicated time points for assessment of serum concentrations|Blood samples will be collected at indicated time points to measure free soluble ST2|Blood samples will be collected at indicated time points to measure total soluble ST2|Blood samples will be collected at indicated time points and anti-GSK3772847 antibodies will be assessed using a tiered approach.|ACQ-5 is a 5-item questionnaire that is a measure of the participant's asthma control. The five questions include about the frequency and/or severity of symptoms like nocturnal awakening, activity limitation, shortness of breath and wheeze. The score scales from zero (totally controlled) and 6 (severely uncontrolled)|AQLQ is 32 items four domains questionnaire used for evaluation of impact of asthma treatments on the quality of life of participants. The scores are evaluated from 1 (total impairment) and 7 (no impairment)|ACQ-5 is a 5 question tool used to measure attributes of asthma control and the score ranges from 0 to 6 where 0 is no impairment/limitation and 6 is total impairment/limitation. A responder to ACQ-5 will be defined as a participant who has a decrease from Baseline in ACQ-5 score of 0.5 or more.|AQLQ is a 32 items four domain questionnaire used to measure quality of life participants due to asthma treatment and the scores ranges from 1 to 7 where 1 indicates total impairment and 7 indicates no impairment. A responder to AQLQ will be defined as a participant who has an increase from Baseline in AQLQ score of 0.5 or more.|Spirometry assessment will include pre-bronchodilator FEV1|Spirometry assessment will include pre-bronchodilator FVC|An AE is any untoward medical occurrence in a clinical study participants, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that, at any dose may result in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment.|Laboratory assessment for hematology parameters will include Platelet count, hemoglobin, Red blood cell (RBC) count, hematocrit, Red blood cell distribution width (RDW), RBC indices like mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH) and mean corpuscular hemoglobin concentration (MCHC). White blood cell (WBC) count with differential will include neutrophils, lymphocytes, monocytes, eosinophils and basophils.|Laboratory assessment for clinical chemistry parameters will include blood urea nitrogen (BUN), potassium, calcium, sodium, creatinine, non-fasting glucose, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline phosphate, Gamma-glutamyl transferase (GGT), albumin, phosphorus, carbon dioxide, total protein, creatine phosphokinase (CPK), total and direct bilirubin|Blood pressure will be measured in supine position after 5 minutes rest|Heart rate will be measured in supine position after 5 minutes rest|Single 12-lead ECG will be obtained using an ECG machine that automatically measures heart rate, PR, QRS, QT, and QT interval corrected for heart rate (QTc) and ventricular rate|Holter assessment will be used for quantitative assessment of abnormal rhythm events. Holter monitor will be placed 30-60 minutes prior to dosing.","Day 1 post-end of infusion, Day 15, Pre-dose on Day 29, Pre-dose and post-dose on Day 57, Day 85 and Day 169|Day 1 Pre and post-dose; Day 15; Day 29 Post dose; Day 57 pre and post dose; Day 85, Day 169|Up to Day 172|Baseline and at Weeks 2, 4, 8 and 12|Up to Day 88|Day 1","GSKClinicalSupportHD@gsk.com","US GSK Clinical Trials Call Center","877-379-3718",{"$nulls":7},"GSK Clinical Trials","2018-02-02","2020-05-25T16:35:48.987","2020-05-26T17:10:42.972","NCT03393806"]
["5ecbf3e5e2561b1b11905ce5","NCT03393806","2018-03-22","GlaxoSmithKline","GSK","Not yet recruiting","Repeat Dose Study of GSK3772847 in Participants With Moderate to Severe Asthma With Allergic Fungal Airway Disease (AFAD)","Gsk-3772847",null,"Yes","['Gsk-3772847']","Unknown",null,"Phase 2",2,46,"Anticipated","2018-03-23","2019-04-09",{"$nulls":5},"This study is multicenter, double-blinded parallel group design, where participants with moderate to severe asthma with AFAD will be enrolled. Participants will receive three doses of 10 milligrams/kilogram (mg/kg) of GSK3772847 every 4 Weeks versus placebo along with standard of care. Participants will be randomized in 1:1 ratio to receive either 10 mg/kg GSK3772847 intravenously (IV) or matching placebo IV. Participants will receive study treatment on Week 0 (Day 1), Week 4 and Week 8. The total duration of the study will be 28 Weeks and approximately 46 participants will be randomized.",null,"A Double Blind (Sponsor Open) Placebo-controlled, Stratified, Parallel Group Study to Evaluate the Efficacy and Safety of Repeat Doses of GSK3772847 in Participants With Moderate to Severe Asthma With Allergic Fungal Airway Disease (AFAD)",207972,"Asthma","Asthma","Bronchial Diseases","Respiratory","Experimental|Placebo Comparator","Participants receiving GSK3772847|Participants receiving placebo","Participants will be randomized to receive GSK3772847 as IV infusion. Participants will receive three doses ( Day 1, Day 29 and Day 57) of GSK3772847 every 4 weeks|Participants will be randomized to receive matching placebo as IV infusion","Drug","GSK3772847|Placebo","GSK3772847 will be available as 100 mg/vial, white to yellow, uniform lyophilized cake in a 5 milliliter (mL) clear glass vial with closure sealed by red metal and yellow overseal.|Commercially sourced sterile normal saline will be provided as Placebo",null,"Participants receiving GSK3772847|Participants receiving placebo","\n\n * Participant must be at least 18 years of age inclusive, at the time of signing the informed consent.\n * Documented history of physician diagnosed moderate or severe asthma for >=12 months based on Guidelines and treated with inhaled corticosteroid (ICS) and long-acting beta-2-agonist (LABA) for at least 4 months (>=500 micrograms/day [Âµg/day]) fluticasone propionate or equivalent as defined in the guidelines.\n * Pre-bronchodilator FEV1 35-79% of predicted value for participant inclusive\n * FeNO >= 25 parts per billion (ppb) at Screening\n * ACQ-5 score >= 1.5 at Screening\n * Blood eosinophil >=300 cells/microliter at Screening\n * Evidence of allergic fungal airway disease like Fungal sensitization to any of the fungi Aspergillus fumigatus, Penicillium chrysogenum (notatum) at screening measured by serum-specific Immunoglobulin (Ig) E test. A history of exacerbations with at least 1 severe exacerbation (defined as requiring a minimum of 3 days of high-dose oral corticosteroids for asthma symptoms) in the previous 12 months.\n * Body weight within 50-150 kilogram (kg)\n * Both male and female gender. A female participant is eligible to participate if she is not pregnant not breastfeeding, Not a woman of childbearing potential (WOCBP) or A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 16 weeks after the last dose of study treatment.\n * Capable of giving signed informed consent\n\n","\n\n * Historical diagnosis of cystic fibrosis\n * Concurrent respiratory diseases: Presence of a known pre-existing, clinically important respiratory conditions (example pneumonia, pneumothorax, atelectasis segmental or larger, pulmonary fibrotic disease, bronchopulmonary dysplasia, chronic bronchitis, emphysema, chronic obstructive pulmonary disease, or other respiratory abnormalities) other than asthma or AFAD\n * Has a history of chronic or recurrent non-pulmonary infectious disease or ongoing non-pulmonary infection including, but not limited to, chronic renal infection, chronic chest infection, recurrent urinary tract infection (example, recurrent pyelonephritis, chronic non-remitting cystitis), or open, draining skin wound or an ulcer\n * Serious infection within 8 weeks of enrolment, including, but not limited to hepatitis, pneumonia, sepsis, or pyelonephritis; or has been hospitalized for an infection; or has been treated with IV antibiotics for an infection, within 8 weeks prior to the first administration of study drug.\n * Evidence of poorly controlled chronic medical conditions other than asthma, example, participants with known, pre-existing, clinically significant endocrine, autoimmune, metabolic, neurological, renal, cardiovascular, gastrointestinal, hepatic, and hematological or any other system abnormalities that are uncontrolled with standard treatment.\n * Cardiovascular disease: Clinically significant organic heart disease\n * Participants with a diagnosis of malignancy or in the process of investigation for a malignancy. Participants with carcinoma that have not been in complete remission for at least 5 years. Participants who have had carcinoma in situ of the cervix, squamous cell carcinoma and basal cell carcinoma of the skin would not be excluded based on the 5 year waiting period if the participant has been considered cured by treatment.\n * Eosinophilic diseases: Other conditions that could lead to elevated eosinophil such as hyper-eosinophilic syndromes. Participants with a known, pre-existing parasitic infestation within 6 months prior to Screening (Visit 1)\n * Prohibited medications is not permitted within the defined time intervals prior to Screening (Visit 1) and throughout the study.\n * Presence of hepatitis B surface antigen (HBsAg), positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study treatment.\n * A known immunodeficiency such as human immunodeficiency virus infection.\n * Hypersensitivity: significant allergies to humanized monoclonal antibodies or biologic or to any components of the formulation used in this study\n * Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear Ig A dermatosis, toxic epidermal necrolysis, and exfoliative dermatitis).\n * Clinically significant abnormality on 12-lead ECG assessment at screening (Visit 1). Site investigators will be provided with ECG over-read conducted by a centralized independent cardiologist, to assist in evaluation of participant eligibility.\n * Sinus bradycardia <45 beats per minute (bpm), sinus tachycardia >= 110 bpm, multifocal atrial tachycardia (wandering atrial pacemaker with rate >100bpm), evidence of Mobitz II second degree or third degree atrioventricular (AV) block, pathological Q waves (defined as wide [>0.04 seconds] and deep [>0.4 millivolts (mV) (4 millimeter [mm] with 10mm/mV setting)] or >25% of the height of the corresponding R wave, providing the R wave was >0.5mV [5mm with 10mm/mV setting], appearing in at least two contiguous leads, evidence of ventricular ectopic couplets, bigeminy, trigeminy or multifocal premature ventricular complexes, for participants without complete right bundle branch block: QTc for heart rate by Fridericia's formula QTc(F) >= 450 millisecond (msec) or an ECG that is unsuitable for QT measurements, for participants with complete right bundle branch block: QTc(F) >=480 msec or an ECG that is unsuitable for QT measurements, ST-T wave abnormalities, clinically significant conduction abnormalities and clinically significant arrhythmias.\n * Smoking history: current smokers or former smokers with a smoking history >= 10 pack years\n * History of alcohol or illegal substance abuse within 2 years prior to Screening (Visit1).\n * Participants at risk of non-compliance, or unable to comply with the study procedures. Participants who are unable to follow study instructions such as visit schedule and paper diary completion. Participants who have known evidence of lack of adherence to controller medication and/or ability to follow physician's recommendations. Any infirmity, disability, or geographic location that would limit compliance for scheduled visits.",{"$nulls":4},"Actual","2018-01-09","Actual","Anticipated","2019-07-02","Anticipated","2018-03-01","2018-01-03","2018-01-03","2018-03-20","No","Asthma Control Questionnaire\nAllergic fungal airway disease\nAsthma Quality of Life Questionnaire\nHolter monitoring\nAsthma","Interventional","Treatment","Parallel Assignment","Double (Participant, Investigator)","Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"No","No",{"$nulls":19},"Change from Baseline in blood eosinophils|Change from Baseline in fractional exhaled nitric oxide (FeNO)","Blood samples will be collected at indicated time points for the assessment of eosinophil|FeNO will be measured using a handheld electronic device","Baseline and up to Day 88","Serum concentrations of GSK3772847|Serum levels of free soluble suppressor of tumorigenicity 2 (ST2)|Serum levels of total soluble ST2|Number of participants with positive result of serum anti-GSK3772847 antibodies post dosing|Titers of serum anti-GSK3772847 antibodies post dosing|Change from Baseline in Asthma Control Questionnaire-5 (ACQ-5) absolute score at Weeks 2, 4, 8 and 12|Change from Baseline in Asthma Quality of Life Questionnaire (AQLQ) total and domain scores at Weeks 2, 4, 8 and 12|Number of responders to ACQ-5|Number of responders to AQLQ|Change from Baseline in forced expiratory volume in 1 second (FEV1)|Change from Baseline in forced vital capacity (FVC)|Number of participants with treatment emergent adverse events (AE) and serious AEs (SAE)|Number of participants with abnormal hematology parameters|Number of participants with abnormal clinical chemistry parameters|Number of participants with abnormal systolic blood pressure (SBP) and diastolic blood pressure (DBP)|Number of participants with abnormal heart rate|Number of participants with abnormal findings in Electrocardiogram (ECG)|Number of participants with abnormal 24-hour Holter findings","Blood samples will be collected at indicated time points for assessment of serum concentrations|Blood samples will be collected at indicated time points to measure free soluble ST2|Blood samples will be collected at indicated time points to measure total soluble ST2|Blood samples will be collected at indicated time points and anti-GSK3772847 antibodies will be assessed using a tiered approach.|ACQ-5 is a 5-item questionnaire that is a measure of the participant's asthma control. The five questions include about the frequency and/or severity of symptoms like nocturnal awakening, activity limitation, shortness of breath and wheeze. The score scales from zero (totally controlled) and 6 (severely uncontrolled)|AQLQ is 32 items four domains questionnaire used for evaluation of impact of asthma treatments on the quality of life of participants. The scores are evaluated from 1 (total impairment) and 7 (no impairment)|ACQ-5 is a 5 question tool used to measure attributes of asthma control and the score ranges from 0 to 6 where 0 is no impairment/limitation and 6 is total impairment/limitation. A responder to ACQ-5 will be defined as a participant who has a decrease from Baseline in ACQ-5 score of 0.5 or more.|AQLQ is a 32 items four domain questionnaire used to measure quality of life participants due to asthma treatment and the scores ranges from 1 to 7 where 1 indicates total impairment and 7 indicates no impairment. A responder to AQLQ will be defined as a participant who has an increase from Baseline in AQLQ score of 0.5 or more.|Spirometry assessment will include pre-bronchodilator FEV1|Spirometry assessment will include pre-bronchodilator FVC|An AE is any untoward medical occurrence in a clinical study participants, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that, at any dose may result in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment.|Laboratory assessment for hematology parameters will include Platelet count, hemoglobin, Red blood cell (RBC) count, hematocrit, Red blood cell distribution width (RDW), RBC indices like mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH) and mean corpuscular hemoglobin concentration (MCHC). White blood cell (WBC) count with differential will include neutrophils, lymphocytes, monocytes, eosinophils and basophils.|Laboratory assessment for clinical chemistry parameters will include blood urea nitrogen (BUN), potassium, calcium, sodium, creatinine, non-fasting glucose, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline phosphate, Gamma-glutamyl transferase (GGT), albumin, phosphorus, carbon dioxide, total protein, creatine phosphokinase (CPK), total and direct bilirubin|Blood pressure will be measured in supine position after 5 minutes rest|Heart rate will be measured in supine position after 5 minutes rest|Single 12-lead ECG will be obtained using an ECG machine that automatically measures heart rate, PR, QRS, QT, and QT interval corrected for heart rate (QTc) and ventricular rate|Holter assessment will be used for quantitative assessment of abnormal rhythm events. Holter monitor will be placed 30-60 minutes prior to dosing.","Day 1 post-end of infusion, Day 15, Pre-dose on Day 29, Pre-dose and post-dose on Day 57, Day 85 and Day 169|Day 1 Pre and post-dose; Day 15; Day 29 Post dose; Day 57 pre and post dose; Day 85, Day 169|Up to Day 172|Baseline and at Weeks 2, 4, 8 and 12|Up to Day 88|Day 1","GSKClinicalSupportHD@gsk.com","US GSK Clinical Trials Call Center","877-379-3718","Edgbaston, United Kingdom, B15 2Gw",null,"United Kingdom","Gsk Investigational Site",{"$nulls":3},"GSK Clinical Trials","2018-03-20","2020-05-25T16:35:49.017","2020-05-26T17:10:42.972","NCT03393806"]
["5ecbf3e5307e3d1b1f8d9c7a","NCT03393806","2018-03-29","GlaxoSmithKline","GSK","Not yet recruiting","Repeat Dose Study of GSK3772847 in Participants With Moderate to Severe Asthma With Allergic Fungal Airway Disease (AFAD)","Gsk-3772847",null,"Yes","['Gsk-3772847']","Unknown",null,"Phase 2",2,46,"Anticipated","2018-04-13","2019-04-09",{"$nulls":5},"This study is multicenter, double-blinded parallel group design, where participants with moderate to severe asthma with AFAD will be enrolled. Participants will receive three doses of 10 milligrams/kilogram (mg/kg) of GSK3772847 every 4 Weeks versus placebo along with standard of care. Participants will be randomized in 1:1 ratio to receive either 10 mg/kg GSK3772847 intravenously (IV) or matching placebo IV. Participants will receive study treatment on Week 0 (Day 1), Week 4 and Week 8. The total duration of the study will be 28 Weeks and approximately 46 participants will be randomized.",null,"A Double Blind (Sponsor Open) Placebo-controlled, Stratified, Parallel Group Study to Evaluate the Efficacy and Safety of Repeat Doses of GSK3772847 in Participants With Moderate to Severe Asthma With Allergic Fungal Airway Disease (AFAD)",207972,"Asthma","Asthma","Bronchial Diseases","Respiratory","Experimental|Placebo Comparator","Participants receiving GSK3772847|Participants receiving placebo","Participants will be randomized to receive GSK3772847 as IV infusion. Participants will receive three doses ( Day 1, Day 29 and Day 57) of GSK3772847 every 4 weeks|Participants will be randomized to receive matching placebo as IV infusion","Drug","GSK3772847|Placebo","GSK3772847 will be available as 100 mg/vial, white to yellow, uniform lyophilized cake in a 5 milliliter (mL) clear glass vial with closure sealed by red metal and yellow overseal.|Commercially sourced sterile normal saline will be provided as Placebo",null,"Participants receiving GSK3772847|Participants receiving placebo","\n\n * Participant must be at least 18 years of age inclusive, at the time of signing the informed consent.\n * Documented history of physician diagnosed moderate or severe asthma for >=12 months based on Guidelines and treated with inhaled corticosteroid (ICS) and long-acting beta-2-agonist (LABA) for at least 4 months (>=500 micrograms/day [Âµg/day]) fluticasone propionate or equivalent as defined in the guidelines.\n * Pre-bronchodilator FEV1 35-79% of predicted value for participant inclusive\n * FeNO >= 25 parts per billion (ppb) at Screening\n * ACQ-5 score >= 1.5 at Screening\n * Blood eosinophil >=300 cells/microliter at Screening\n * Evidence of allergic fungal airway disease like Fungal sensitization to any of the fungi Aspergillus fumigatus, Penicillium chrysogenum (notatum) at screening measured by serum-specific Immunoglobulin (Ig) E test. A history of exacerbations with at least 1 severe exacerbation (defined as requiring a minimum of 3 days of high-dose oral corticosteroids for asthma symptoms) in the previous 12 months.\n * Body weight within 50-150 kilogram (kg)\n * Both male and female gender. A female participant is eligible to participate if she is not pregnant not breastfeeding, Not a woman of childbearing potential (WOCBP) or A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 16 weeks after the last dose of study treatment.\n * Capable of giving signed informed consent\n\n","\n\n * Historical diagnosis of cystic fibrosis\n * Concurrent respiratory diseases: Presence of a known pre-existing, clinically important respiratory conditions (example pneumonia, pneumothorax, atelectasis segmental or larger, pulmonary fibrotic disease, bronchopulmonary dysplasia, chronic bronchitis, emphysema, chronic obstructive pulmonary disease, or other respiratory abnormalities) other than asthma or AFAD\n * Has a history of chronic or recurrent non-pulmonary infectious disease or ongoing non-pulmonary infection including, but not limited to, chronic renal infection, chronic chest infection, recurrent urinary tract infection (example, recurrent pyelonephritis, chronic non-remitting cystitis), or open, draining skin wound or an ulcer\n * Serious infection within 8 weeks of enrolment, including, but not limited to hepatitis, pneumonia, sepsis, or pyelonephritis; or has been hospitalized for an infection; or has been treated with IV antibiotics for an infection, within 8 weeks prior to the first administration of study drug.\n * Evidence of poorly controlled chronic medical conditions other than asthma, example, participants with known, pre-existing, clinically significant endocrine, autoimmune, metabolic, neurological, renal, cardiovascular, gastrointestinal, hepatic, and hematological or any other system abnormalities that are uncontrolled with standard treatment.\n * Cardiovascular disease: Clinically significant organic heart disease\n * Participants with a diagnosis of malignancy or in the process of investigation for a malignancy. Participants with carcinoma that have not been in complete remission for at least 5 years. Participants who have had carcinoma in situ of the cervix, squamous cell carcinoma and basal cell carcinoma of the skin would not be excluded based on the 5 year waiting period if the participant has been considered cured by treatment.\n * Eosinophilic diseases: Other conditions that could lead to elevated eosinophil such as hyper-eosinophilic syndromes. Participants with a known, pre-existing parasitic infestation within 6 months prior to Screening (Visit 1)\n * Prohibited medications is not permitted within the defined time intervals prior to Screening (Visit 1) and throughout the study.\n * Presence of hepatitis B surface antigen (HBsAg), positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study treatment.\n * A known immunodeficiency such as human immunodeficiency virus infection.\n * Hypersensitivity: significant allergies to humanized monoclonal antibodies or biologic or to any components of the formulation used in this study\n * Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear Ig A dermatosis, toxic epidermal necrolysis, and exfoliative dermatitis).\n * Clinically significant abnormality on 12-lead ECG assessment at screening (Visit 1). Site investigators will be provided with ECG over-read conducted by a centralized independent cardiologist, to assist in evaluation of participant eligibility.\n * Sinus bradycardia <45 beats per minute (bpm), sinus tachycardia >= 110 bpm, multifocal atrial tachycardia (wandering atrial pacemaker with rate >100bpm), evidence of Mobitz II second degree or third degree atrioventricular (AV) block, pathological Q waves (defined as wide [>0.04 seconds] and deep [>0.4 millivolts (mV) (4 millimeter [mm] with 10mm/mV setting)] or >25% of the height of the corresponding R wave, providing the R wave was >0.5mV [5mm with 10mm/mV setting], appearing in at least two contiguous leads, evidence of ventricular ectopic couplets, bigeminy, trigeminy or multifocal premature ventricular complexes, for participants without complete right bundle branch block: QTc for heart rate by Fridericia's formula QTc(F) >= 450 millisecond (msec) or an ECG that is unsuitable for QT measurements, for participants with complete right bundle branch block: QTc(F) >=480 msec or an ECG that is unsuitable for QT measurements, ST-T wave abnormalities, clinically significant conduction abnormalities and clinically significant arrhythmias.\n * Smoking history: current smokers or former smokers with a smoking history >= 10 pack years\n * History of alcohol or illegal substance abuse within 2 years prior to Screening (Visit1).\n * Participants at risk of non-compliance, or unable to comply with the study procedures. Participants who are unable to follow study instructions such as visit schedule and paper diary completion. Participants who have known evidence of lack of adherence to controller medication and/or ability to follow physician's recommendations. Any infirmity, disability, or geographic location that would limit compliance for scheduled visits.",{"$nulls":4},"Actual","2018-01-09","Actual","Anticipated","2019-07-02","Anticipated","2018-03-01","2018-01-03","2018-01-03","2018-03-26","No","Asthma Control Questionnaire\nAllergic fungal airway disease\nAsthma Quality of Life Questionnaire\nHolter monitoring\nAsthma","Interventional","Treatment","Parallel Assignment","Double (Participant, Investigator)","Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"No","No",{"$nulls":19},"Change from Baseline in blood eosinophils|Change from Baseline in fractional exhaled nitric oxide (FeNO)","Blood samples will be collected at indicated time points for the assessment of eosinophil|FeNO will be measured using a handheld electronic device","Baseline and up to Day 88","Serum concentrations of GSK3772847|Serum levels of free soluble suppressor of tumorigenicity 2 (ST2)|Serum levels of total soluble ST2|Number of participants with positive result of serum anti-GSK3772847 antibodies post dosing|Titers of serum anti-GSK3772847 antibodies post dosing|Change from Baseline in Asthma Control Questionnaire-5 (ACQ-5) absolute score at Weeks 2, 4, 8 and 12|Change from Baseline in Asthma Quality of Life Questionnaire (AQLQ) total and domain scores at Weeks 2, 4, 8 and 12|Number of responders to ACQ-5|Number of responders to AQLQ|Change from Baseline in forced expiratory volume in 1 second (FEV1)|Change from Baseline in forced vital capacity (FVC)|Number of participants with treatment emergent adverse events (AE) and serious AEs (SAE)|Number of participants with abnormal hematology parameters|Number of participants with abnormal clinical chemistry parameters|Number of participants with abnormal systolic blood pressure (SBP) and diastolic blood pressure (DBP)|Number of participants with abnormal heart rate|Number of participants with abnormal findings in Electrocardiogram (ECG)|Number of participants with abnormal 24-hour Holter findings","Blood samples will be collected at indicated time points for assessment of serum concentrations|Blood samples will be collected at indicated time points to measure free soluble ST2|Blood samples will be collected at indicated time points to measure total soluble ST2|Blood samples will be collected at indicated time points and anti-GSK3772847 antibodies will be assessed using a tiered approach.|ACQ-5 is a 5-item questionnaire that is a measure of the participant's asthma control. The five questions include about the frequency and/or severity of symptoms like nocturnal awakening, activity limitation, shortness of breath and wheeze. The score scales from zero (totally controlled) and 6 (severely uncontrolled)|AQLQ is 32 items four domains questionnaire used for evaluation of impact of asthma treatments on the quality of life of participants. The scores are evaluated from 1 (total impairment) and 7 (no impairment)|ACQ-5 is a 5 question tool used to measure attributes of asthma control and the score ranges from 0 to 6 where 0 is no impairment/limitation and 6 is total impairment/limitation. A responder to ACQ-5 will be defined as a participant who has a decrease from Baseline in ACQ-5 score of 0.5 or more.|AQLQ is a 32 items four domain questionnaire used to measure quality of life participants due to asthma treatment and the scores ranges from 1 to 7 where 1 indicates total impairment and 7 indicates no impairment. A responder to AQLQ will be defined as a participant who has an increase from Baseline in AQLQ score of 0.5 or more.|Spirometry assessment will include pre-bronchodilator FEV1|Spirometry assessment will include pre-bronchodilator FVC|An AE is any untoward medical occurrence in a clinical study participants, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that, at any dose may result in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment.|Laboratory assessment for hematology parameters will include Platelet count, hemoglobin, Red blood cell (RBC) count, hematocrit, Red blood cell distribution width (RDW), RBC indices like mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH) and mean corpuscular hemoglobin concentration (MCHC). White blood cell (WBC) count with differential will include neutrophils, lymphocytes, monocytes, eosinophils and basophils.|Laboratory assessment for clinical chemistry parameters will include blood urea nitrogen (BUN), potassium, calcium, sodium, creatinine, non-fasting glucose, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline phosphate, Gamma-glutamyl transferase (GGT), albumin, phosphorus, carbon dioxide, total protein, creatine phosphokinase (CPK), total and direct bilirubin|Blood pressure will be measured in supine position after 5 minutes rest|Heart rate will be measured in supine position after 5 minutes rest|Single 12-lead ECG will be obtained using an ECG machine that automatically measures heart rate, PR, QRS, QT, and QT interval corrected for heart rate (QTc) and ventricular rate|Holter assessment will be used for quantitative assessment of abnormal rhythm events. Holter monitor will be placed 30-60 minutes prior to dosing.","Day 1 post-end of infusion, Day 15, Pre-dose on Day 29, Pre-dose and post-dose on Day 57, Day 85 and Day 169|Day 1 Pre and post-dose; Day 15; Day 29 Post dose; Day 57 pre and post dose; Day 85, Day 169|Up to Day 172|Baseline and at Weeks 2, 4, 8 and 12|Up to Day 88|Day 1","GSKClinicalSupportHD@gsk.com","US GSK Clinical Trials Call Center","877-379-3718","Edgbaston, United Kingdom, B15 2Gw",null,"United Kingdom","Gsk Investigational Site",{"$nulls":3},"GSK Clinical Trials","2018-03-26","2020-05-25T16:35:49.006","2020-05-26T17:10:42.972","NCT03393806"]
["5ecbf3e5e2561b1b11905ce6","NCT03393806","2018-04-19","GlaxoSmithKline","GSK","Not yet recruiting","Repeat Dose Study of GSK3772847 in Participants With Moderate to Severe Asthma With Allergic Fungal Airway Disease (AFAD)","Gsk-3772847",null,"Yes","['Gsk-3772847']","Unknown",null,"Phase 2",2,46,"Anticipated","2018-04-20","2019-04-09",{"$nulls":5},"This study is multicenter, double-blinded parallel group design, where participants with moderate to severe asthma with AFAD will be enrolled. Participants will receive three doses of 10 milligrams/kilogram (mg/kg) of GSK3772847 every 4 Weeks versus placebo along with standard of care. Participants will be randomized in 1:1 ratio to receive either 10 mg/kg GSK3772847 intravenously (IV) or matching placebo IV. Participants will receive study treatment on Week 0 (Day 1), Week 4 and Week 8. The total duration of the study will be 28 Weeks and approximately 46 participants will be randomized.",null,"A Double Blind (Sponsor Open) Placebo-controlled, Stratified, Parallel Group Study to Evaluate the Efficacy and Safety of Repeat Doses of GSK3772847 in Participants With Moderate to Severe Asthma With Allergic Fungal Airway Disease (AFAD)",207972,"Asthma","Asthma","Bronchial Diseases","Respiratory","Experimental|Placebo Comparator","Participants receiving GSK3772847|Participants receiving placebo","Participants will be randomized to receive GSK3772847 as IV infusion. Participants will receive three doses ( Day 1, Day 29 and Day 57) of GSK3772847 every 4 weeks|Participants will be randomized to receive matching placebo as IV infusion","Drug","GSK3772847|Placebo","GSK3772847 will be available as 100 mg/vial, white to yellow, uniform lyophilized cake in a 5 milliliter (mL) clear glass vial with closure sealed by red metal and yellow overseal.|Commercially sourced sterile normal saline will be provided as Placebo",null,"Participants receiving GSK3772847|Participants receiving placebo","\n\n * Participant must be at least 18 years of age inclusive, at the time of signing the informed consent.\n * Documented history of physician diagnosed moderate or severe asthma for >=12 months based on Guidelines and treated with inhaled corticosteroid (ICS) and long-acting beta-2-agonist (LABA) for at least 4 months (>=500 micrograms/day [Âµg/day]) fluticasone propionate or equivalent as defined in the guidelines.\n * Pre-bronchodilator FEV1 35-79% of predicted value for participant inclusive\n * FeNO >= 25 parts per billion (ppb) at Screening\n * ACQ-5 score >= 1.5 at Screening\n * Blood eosinophil >=300 cells/microliter at Screening\n * Evidence of allergic fungal airway disease like Fungal sensitization to any of the fungi Aspergillus fumigatus, Penicillium chrysogenum (notatum) at screening measured by serum-specific Immunoglobulin (Ig) E test. A history of exacerbations with at least 1 severe exacerbation (defined as requiring a minimum of 3 days of high-dose oral corticosteroids for asthma symptoms) in the previous 12 months.\n * Body weight within 50-150 kilogram (kg)\n * Both male and female gender. A female participant is eligible to participate if she is not pregnant not breastfeeding, Not a woman of childbearing potential (WOCBP) or A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 16 weeks after the last dose of study treatment.\n * Capable of giving signed informed consent\n\n","\n\n * Historical diagnosis of cystic fibrosis\n * Concurrent respiratory diseases: Presence of a known pre-existing, clinically important respiratory conditions (example pneumonia, pneumothorax, atelectasis segmental or larger, pulmonary fibrotic disease, bronchopulmonary dysplasia, chronic bronchitis, emphysema, chronic obstructive pulmonary disease, or other respiratory abnormalities) other than asthma or AFAD\n * Has a history of chronic or recurrent non-pulmonary infectious disease or ongoing non-pulmonary infection including, but not limited to, chronic renal infection, chronic chest infection, recurrent urinary tract infection (example, recurrent pyelonephritis, chronic non-remitting cystitis), or open, draining skin wound or an ulcer\n * Serious infection within 8 weeks of enrolment, including, but not limited to hepatitis, pneumonia, sepsis, or pyelonephritis; or has been hospitalized for an infection; or has been treated with IV antibiotics for an infection, within 8 weeks prior to the first administration of study drug.\n * Evidence of poorly controlled chronic medical conditions other than asthma, example, participants with known, pre-existing, clinically significant endocrine, autoimmune, metabolic, neurological, renal, cardiovascular, gastrointestinal, hepatic, and hematological or any other system abnormalities that are uncontrolled with standard treatment.\n * Cardiovascular disease: Clinically significant organic heart disease\n * Participants with a diagnosis of malignancy or in the process of investigation for a malignancy. Participants with carcinoma that have not been in complete remission for at least 5 years. Participants who have had carcinoma in situ of the cervix, squamous cell carcinoma and basal cell carcinoma of the skin would not be excluded based on the 5 year waiting period if the participant has been considered cured by treatment.\n * Eosinophilic diseases: Other conditions that could lead to elevated eosinophil such as hyper-eosinophilic syndromes. Participants with a known, pre-existing parasitic infestation within 6 months prior to Screening (Visit 1)\n * Prohibited medications is not permitted within the defined time intervals prior to Screening (Visit 1) and throughout the study.\n * Presence of hepatitis B surface antigen (HBsAg), positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study treatment.\n * A known immunodeficiency such as human immunodeficiency virus infection.\n * Hypersensitivity: significant allergies to humanized monoclonal antibodies or biologic or to any components of the formulation used in this study\n * Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear Ig A dermatosis, toxic epidermal necrolysis, and exfoliative dermatitis).\n * Clinically significant abnormality on 12-lead ECG assessment at screening (Visit 1). Site investigators will be provided with ECG over-read conducted by a centralized independent cardiologist, to assist in evaluation of participant eligibility.\n * Sinus bradycardia <45 beats per minute (bpm), sinus tachycardia >= 110 bpm, multifocal atrial tachycardia (wandering atrial pacemaker with rate >100bpm), evidence of Mobitz II second degree or third degree atrioventricular (AV) block, pathological Q waves (defined as wide [>0.04 seconds] and deep [>0.4 millivolts (mV) (4 millimeter [mm] with 10mm/mV setting)] or >25% of the height of the corresponding R wave, providing the R wave was >0.5mV [5mm with 10mm/mV setting], appearing in at least two contiguous leads, evidence of ventricular ectopic couplets, bigeminy, trigeminy or multifocal premature ventricular complexes, for participants without complete right bundle branch block: QTc for heart rate by Fridericia's formula QTc(F) >= 450 millisecond (msec) or an ECG that is unsuitable for QT measurements, for participants with complete right bundle branch block: QTc(F) >=480 msec or an ECG that is unsuitable for QT measurements, ST-T wave abnormalities, clinically significant conduction abnormalities and clinically significant arrhythmias.\n * Smoking history: current smokers or former smokers with a smoking history >= 10 pack years\n * History of alcohol or illegal substance abuse within 2 years prior to Screening (Visit1).\n * Participants at risk of non-compliance, or unable to comply with the study procedures. Participants who are unable to follow study instructions such as visit schedule and paper diary completion. Participants who have known evidence of lack of adherence to controller medication and/or ability to follow physician's recommendations. Any infirmity, disability, or geographic location that would limit compliance for scheduled visits.",{"$nulls":4},"Actual","2018-01-09","Actual","Anticipated","2019-07-02","Anticipated","2018-04-01","2018-01-03","2018-01-03","2018-04-18","No","Asthma Control Questionnaire\nAllergic fungal airway disease\nAsthma Quality of Life Questionnaire\nHolter monitoring\nAsthma","Interventional","Treatment","Parallel Assignment","Double (Participant, Investigator)","Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"No","No",{"$nulls":19},"Change from Baseline in blood eosinophils|Change from Baseline in fractional exhaled nitric oxide (FeNO)","Blood samples will be collected at indicated time points for the assessment of eosinophil|FeNO will be measured using a handheld electronic device","Baseline and up to Day 88","Serum concentrations of GSK3772847|Serum levels of free soluble suppressor of tumorigenicity 2 (ST2)|Serum levels of total soluble ST2|Number of participants with positive result of serum anti-GSK3772847 antibodies post dosing|Titers of serum anti-GSK3772847 antibodies post dosing|Change from Baseline in Asthma Control Questionnaire-5 (ACQ-5) absolute score at Weeks 2, 4, 8 and 12|Change from Baseline in Asthma Quality of Life Questionnaire (AQLQ) total and domain scores at Weeks 2, 4, 8 and 12|Number of responders to ACQ-5|Number of responders to AQLQ|Change from Baseline in forced expiratory volume in 1 second (FEV1)|Change from Baseline in forced vital capacity (FVC)|Number of participants with treatment emergent adverse events (AE) and serious AEs (SAE)|Number of participants with abnormal hematology parameters|Number of participants with abnormal clinical chemistry parameters|Number of participants with abnormal systolic blood pressure (SBP) and diastolic blood pressure (DBP)|Number of participants with abnormal heart rate|Number of participants with abnormal findings in Electrocardiogram (ECG)|Number of participants with abnormal 24-hour Holter findings","Blood samples will be collected at indicated time points for assessment of serum concentrations|Blood samples will be collected at indicated time points to measure free soluble ST2|Blood samples will be collected at indicated time points to measure total soluble ST2|Blood samples will be collected at indicated time points and anti-GSK3772847 antibodies will be assessed using a tiered approach.|ACQ-5 is a 5-item questionnaire that is a measure of the participant's asthma control. The five questions include about the frequency and/or severity of symptoms like nocturnal awakening, activity limitation, shortness of breath and wheeze. The score scales from zero (totally controlled) and 6 (severely uncontrolled)|AQLQ is 32 items four domains questionnaire used for evaluation of impact of asthma treatments on the quality of life of participants. The scores are evaluated from 1 (total impairment) and 7 (no impairment)|ACQ-5 is a 5 question tool used to measure attributes of asthma control and the score ranges from 0 to 6 where 0 is no impairment/limitation and 6 is total impairment/limitation. A responder to ACQ-5 will be defined as a participant who has a decrease from Baseline in ACQ-5 score of 0.5 or more.|AQLQ is a 32 items four domain questionnaire used to measure quality of life participants due to asthma treatment and the scores ranges from 1 to 7 where 1 indicates total impairment and 7 indicates no impairment. A responder to AQLQ will be defined as a participant who has an increase from Baseline in AQLQ score of 0.5 or more.|Spirometry assessment will include pre-bronchodilator FEV1|Spirometry assessment will include pre-bronchodilator FVC|An AE is any untoward medical occurrence in a clinical study participants, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that, at any dose may result in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment.|Laboratory assessment for hematology parameters will include Platelet count, hemoglobin, Red blood cell (RBC) count, hematocrit, Red blood cell distribution width (RDW), RBC indices like mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH) and mean corpuscular hemoglobin concentration (MCHC). White blood cell (WBC) count with differential will include neutrophils, lymphocytes, monocytes, eosinophils and basophils.|Laboratory assessment for clinical chemistry parameters will include blood urea nitrogen (BUN), potassium, calcium, sodium, creatinine, non-fasting glucose, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline phosphate, Gamma-glutamyl transferase (GGT), albumin, phosphorus, carbon dioxide, total protein, creatine phosphokinase (CPK), total and direct bilirubin|Blood pressure will be measured in supine position after 5 minutes rest|Heart rate will be measured in supine position after 5 minutes rest|Single 12-lead ECG will be obtained using an ECG machine that automatically measures heart rate, PR, QRS, QT, and QT interval corrected for heart rate (QTc) and ventricular rate|Holter assessment will be used for quantitative assessment of abnormal rhythm events. Holter monitor will be placed 30-60 minutes prior to dosing.","Day 1 post-end of infusion, Day 15, Pre-dose on Day 29, Pre-dose and post-dose on Day 57, Day 85 and Day 169|Day 1 Pre and post-dose; Day 15; Day 29 Post dose; Day 57 pre and post dose; Day 85, Day 169|Up to Day 172|Baseline and at Weeks 2, 4, 8 and 12|Up to Day 88|Day 1","GSKClinicalSupportHD@gsk.com","US GSK Clinical Trials Call Center","877-379-3718","Montpellier Cedex 5, France, 34295|Edgbaston, United Kingdom, B15 2Gw",null,"France|United Kingdom","Gsk Investigational Site",{"$nulls":3},"GSK Clinical Trials","2018-04-18","2020-05-25T16:35:49.190","2020-05-26T17:10:42.972","NCT03393806"]
["5ecbf3e5307e3d1b1f8d9c7b","NCT03393806","2018-05-02","GlaxoSmithKline","GSK","Recruiting","Repeat Dose Study of GSK3772847 in Participants With Moderate to Severe Asthma With Allergic Fungal Airway Disease (AFAD)","Gsk-3772847",null,"Yes","['Gsk-3772847']","Unknown",null,"Phase 2",2,46,"Anticipated","2018-04-18","2019-04-09",{"$nulls":5},"This study is multicenter, double-blinded parallel group design, where participants with moderate to severe asthma with AFAD will be enrolled. Participants will receive three doses of 10 milligrams/kilogram (mg/kg) of GSK3772847 every 4 Weeks versus placebo along with standard of care. Participants will be randomized in 1:1 ratio to receive either 10 mg/kg GSK3772847 intravenously (IV) or matching placebo IV. Participants will receive study treatment on Week 0 (Day 1), Week 4 and Week 8. The total duration of the study will be 28 Weeks and approximately 46 participants will be randomized.",null,"A Double Blind (Sponsor Open) Placebo-controlled, Stratified, Parallel Group Study to Evaluate the Efficacy and Safety of Repeat Doses of GSK3772847 in Participants With Moderate to Severe Asthma With Allergic Fungal Airway Disease (AFAD)",207972,"Asthma","Asthma","Bronchial Diseases","Respiratory","Experimental|Placebo Comparator","Participants receiving GSK3772847|Participants receiving placebo","Participants will be randomized to receive GSK3772847 as IV infusion. Participants will receive three doses ( Day 1, Day 29 and Day 57) of GSK3772847 every 4 weeks|Participants will be randomized to receive matching placebo as IV infusion","Drug","GSK3772847|Placebo","GSK3772847 will be available as 100 mg/vial, white to yellow, uniform lyophilized cake in a 5 milliliter (mL) clear glass vial with closure sealed by red metal and yellow overseal.|Commercially sourced sterile normal saline will be provided as Placebo",null,"Participants receiving GSK3772847|Participants receiving placebo","\n\n * Participant must be at least 18 years of age inclusive, at the time of signing the informed consent.\n * Documented history of physician diagnosed moderate or severe asthma for >=12 months based on Guidelines and treated with inhaled corticosteroid (ICS) and long-acting beta-2-agonist (LABA) for at least 4 months (>=500 micrograms/day [Âµg/day]) fluticasone propionate or equivalent as defined in the guidelines.\n * Pre-bronchodilator FEV1 35-79% of predicted value for participant inclusive\n * FeNO >= 25 parts per billion (ppb) at Screening\n * ACQ-5 score >= 1.5 at Screening\n * Blood eosinophil >=300 cells/microliter at Screening\n * Evidence of allergic fungal airway disease like Fungal sensitization to any of the fungi Aspergillus fumigatus, Penicillium chrysogenum (notatum) at screening measured by serum-specific Immunoglobulin (Ig) E test. A history of exacerbations with at least 1 severe exacerbation (defined as requiring a minimum of 3 days of high-dose oral corticosteroids for asthma symptoms) in the previous 12 months.\n * Body weight within 50-150 kilogram (kg)\n * Both male and female gender. A female participant is eligible to participate if she is not pregnant not breastfeeding, Not a woman of childbearing potential (WOCBP) or A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 16 weeks after the last dose of study treatment.\n * Capable of giving signed informed consent\n\n","\n\n * Historical diagnosis of cystic fibrosis\n * Concurrent respiratory diseases: Presence of a known pre-existing, clinically important respiratory conditions (example pneumonia, pneumothorax, atelectasis segmental or larger, pulmonary fibrotic disease, bronchopulmonary dysplasia, chronic bronchitis, emphysema, chronic obstructive pulmonary disease, or other respiratory abnormalities) other than asthma or AFAD\n * Has a history of chronic or recurrent non-pulmonary infectious disease or ongoing non-pulmonary infection including, but not limited to, chronic renal infection, chronic chest infection, recurrent urinary tract infection (example, recurrent pyelonephritis, chronic non-remitting cystitis), or open, draining skin wound or an ulcer\n * Serious infection within 8 weeks of enrolment, including, but not limited to hepatitis, pneumonia, sepsis, or pyelonephritis; or has been hospitalized for an infection; or has been treated with IV antibiotics for an infection, within 8 weeks prior to the first administration of study drug.\n * Evidence of poorly controlled chronic medical conditions other than asthma, example, participants with known, pre-existing, clinically significant endocrine, autoimmune, metabolic, neurological, renal, cardiovascular, gastrointestinal, hepatic, and hematological or any other system abnormalities that are uncontrolled with standard treatment.\n * Cardiovascular disease: Clinically significant organic heart disease\n * Participants with a diagnosis of malignancy or in the process of investigation for a malignancy. Participants with carcinoma that have not been in complete remission for at least 5 years. Participants who have had carcinoma in situ of the cervix, squamous cell carcinoma and basal cell carcinoma of the skin would not be excluded based on the 5 year waiting period if the participant has been considered cured by treatment.\n * Eosinophilic diseases: Other conditions that could lead to elevated eosinophil such as hyper-eosinophilic syndromes. Participants with a known, pre-existing parasitic infestation within 6 months prior to Screening (Visit 1)\n * Prohibited medications is not permitted within the defined time intervals prior to Screening (Visit 1) and throughout the study.\n * Presence of hepatitis B surface antigen (HBsAg), positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study treatment.\n * A known immunodeficiency such as human immunodeficiency virus infection.\n * Hypersensitivity: significant allergies to humanized monoclonal antibodies or biologic or to any components of the formulation used in this study\n * Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear Ig A dermatosis, toxic epidermal necrolysis, and exfoliative dermatitis).\n * Clinically significant abnormality on 12-lead ECG assessment at screening (Visit 1). Site investigators will be provided with ECG over-read conducted by a centralized independent cardiologist, to assist in evaluation of participant eligibility.\n * Sinus bradycardia <45 beats per minute (bpm), sinus tachycardia >= 110 bpm, multifocal atrial tachycardia (wandering atrial pacemaker with rate >100bpm), evidence of Mobitz II second degree or third degree atrioventricular (AV) block, pathological Q waves (defined as wide [>0.04 seconds] and deep [>0.4 millivolts (mV) (4 millimeter [mm] with 10mm/mV setting)] or >25% of the height of the corresponding R wave, providing the R wave was >0.5mV [5mm with 10mm/mV setting], appearing in at least two contiguous leads, evidence of ventricular ectopic couplets, bigeminy, trigeminy or multifocal premature ventricular complexes, for participants without complete right bundle branch block: QTc for heart rate by Fridericia's formula QTc(F) >= 450 millisecond (msec) or an ECG that is unsuitable for QT measurements, for participants with complete right bundle branch block: QTc(F) >=480 msec or an ECG that is unsuitable for QT measurements, ST-T wave abnormalities, clinically significant conduction abnormalities and clinically significant arrhythmias.\n * Smoking history: current smokers or former smokers with a smoking history >= 10 pack years\n * History of alcohol or illegal substance abuse within 2 years prior to Screening (Visit1).\n * Participants at risk of non-compliance, or unable to comply with the study procedures. Participants who are unable to follow study instructions such as visit schedule and paper diary completion. Participants who have known evidence of lack of adherence to controller medication and/or ability to follow physician's recommendations. Any infirmity, disability, or geographic location that would limit compliance for scheduled visits.",{"$nulls":4},"Actual","2018-01-09","Actual","Anticipated","2019-07-02","Anticipated","2018-04-01","2018-01-03","2018-01-03","2018-04-30","No","Asthma Control Questionnaire\nAllergic fungal airway disease\nAsthma Quality of Life Questionnaire\nHolter monitoring\nAsthma","Interventional","Treatment","Parallel Assignment","Double (Participant, Investigator)","Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"No","No",{"$nulls":19},"Change from Baseline in blood eosinophils|Change from Baseline in fractional exhaled nitric oxide (FeNO)","Blood samples will be collected at indicated time points for the assessment of eosinophil|FeNO will be measured using a handheld electronic device","Baseline and up to Day 88","Serum concentrations of GSK3772847|Serum levels of free soluble suppressor of tumorigenicity 2 (ST2)|Serum levels of total soluble ST2|Number of participants with positive result of serum anti-GSK3772847 antibodies post dosing|Titers of serum anti-GSK3772847 antibodies post dosing|Change from Baseline in Asthma Control Questionnaire-5 (ACQ-5) absolute score at Weeks 2, 4, 8 and 12|Change from Baseline in Asthma Quality of Life Questionnaire (AQLQ) total and domain scores at Weeks 2, 4, 8 and 12|Number of responders to ACQ-5|Number of responders to AQLQ|Change from Baseline in forced expiratory volume in 1 second (FEV1)|Change from Baseline in forced vital capacity (FVC)|Number of participants with treatment emergent adverse events (AE) and serious AEs (SAE)|Number of participants with abnormal hematology parameters|Number of participants with abnormal clinical chemistry parameters|Number of participants with abnormal systolic blood pressure (SBP) and diastolic blood pressure (DBP)|Number of participants with abnormal heart rate|Number of participants with abnormal findings in Electrocardiogram (ECG)|Number of participants with abnormal 24-hour Holter findings","Blood samples will be collected at indicated time points for assessment of serum concentrations|Blood samples will be collected at indicated time points to measure free soluble ST2|Blood samples will be collected at indicated time points to measure total soluble ST2|Blood samples will be collected at indicated time points and anti-GSK3772847 antibodies will be assessed using a tiered approach.|ACQ-5 is a 5-item questionnaire that is a measure of the participant's asthma control. The five questions include about the frequency and/or severity of symptoms like nocturnal awakening, activity limitation, shortness of breath and wheeze. The score scales from zero (totally controlled) and 6 (severely uncontrolled)|AQLQ is 32 items four domains questionnaire used for evaluation of impact of asthma treatments on the quality of life of participants. The scores are evaluated from 1 (total impairment) and 7 (no impairment)|ACQ-5 is a 5 question tool used to measure attributes of asthma control and the score ranges from 0 to 6 where 0 is no impairment/limitation and 6 is total impairment/limitation. A responder to ACQ-5 will be defined as a participant who has a decrease from Baseline in ACQ-5 score of 0.5 or more.|AQLQ is a 32 items four domain questionnaire used to measure quality of life participants due to asthma treatment and the scores ranges from 1 to 7 where 1 indicates total impairment and 7 indicates no impairment. A responder to AQLQ will be defined as a participant who has an increase from Baseline in AQLQ score of 0.5 or more.|Spirometry assessment will include pre-bronchodilator FEV1|Spirometry assessment will include pre-bronchodilator FVC|An AE is any untoward medical occurrence in a clinical study participants, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that, at any dose may result in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment.|Laboratory assessment for hematology parameters will include Platelet count, hemoglobin, Red blood cell (RBC) count, hematocrit, Red blood cell distribution width (RDW), RBC indices like mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH) and mean corpuscular hemoglobin concentration (MCHC). White blood cell (WBC) count with differential will include neutrophils, lymphocytes, monocytes, eosinophils and basophils.|Laboratory assessment for clinical chemistry parameters will include blood urea nitrogen (BUN), potassium, calcium, sodium, creatinine, non-fasting glucose, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline phosphate, Gamma-glutamyl transferase (GGT), albumin, phosphorus, carbon dioxide, total protein, creatine phosphokinase (CPK), total and direct bilirubin|Blood pressure will be measured in supine position after 5 minutes rest|Heart rate will be measured in supine position after 5 minutes rest|Single 12-lead ECG will be obtained using an ECG machine that automatically measures heart rate, PR, QRS, QT, and QT interval corrected for heart rate (QTc) and ventricular rate|Holter assessment will be used for quantitative assessment of abnormal rhythm events. Holter monitor will be placed 30-60 minutes prior to dosing.","Day 1 post-end of infusion, Day 15, Pre-dose on Day 29, Pre-dose and post-dose on Day 57, Day 85 and Day 169|Day 1 Pre and post-dose; Day 15; Day 29 Post dose; Day 57 pre and post dose; Day 85, Day 169|Up to Day 172|Baseline and at Weeks 2, 4, 8 and 12|Up to Day 88|Day 1","GSKClinicalSupportHD@gsk.com","US GSK Clinical Trials Call Center","877-379-3718","Montpellier Cedex 5, France, 34295|Leicester, Leicestershire, United Kingdom, Le3 9Qp|Edgbaston, United Kingdom, B15 2Gw",null,"France|United Kingdom","Gsk Investigational Site|, Leicestershire Gsk Investigational Site",{"$nulls":3},"GSK Clinical Trials","2018-04-30","2020-05-25T16:35:49.132","2020-05-26T17:10:42.972","NCT03393806"]
["5ecbf3e5feab101b1553081a","NCT03393806","2018-05-09","GlaxoSmithKline","GSK","Recruiting","Repeat Dose Study of GSK3772847 in Participants With Moderate to Severe Asthma With Allergic Fungal Airway Disease (AFAD)","Gsk-3772847",null,"Yes","['Gsk-3772847']","Unknown",null,"Phase 2",2,46,"Anticipated","2018-04-18","2019-04-09",{"$nulls":5},"This study is multicenter, double-blinded parallel group design, where participants with moderate to severe asthma with AFAD will be enrolled. Participants will receive three doses of 10 milligrams/kilogram (mg/kg) of GSK3772847 every 4 Weeks versus placebo along with standard of care. Participants will be randomized in 1:1 ratio to receive either 10 mg/kg GSK3772847 intravenously (IV) or matching placebo IV. Participants will receive study treatment on Week 0 (Day 1), Week 4 and Week 8. The total duration of the study will be 28 Weeks and approximately 46 participants will be randomized.",null,"A Double Blind (Sponsor Open) Placebo-controlled, Stratified, Parallel Group Study to Evaluate the Efficacy and Safety of Repeat Doses of GSK3772847 in Participants With Moderate to Severe Asthma With Allergic Fungal Airway Disease (AFAD)",207972,"Asthma","Asthma","Bronchial Diseases","Respiratory","Experimental|Placebo Comparator","Participants receiving GSK3772847|Participants receiving placebo","Participants will be randomized to receive GSK3772847 as IV infusion. Participants will receive three doses ( Day 1, Day 29 and Day 57) of GSK3772847 every 4 weeks|Participants will be randomized to receive matching placebo as IV infusion","Drug","GSK3772847|Placebo","GSK3772847 will be available as 100 mg/vial, white to yellow, uniform lyophilized cake in a 5 milliliter (mL) clear glass vial with closure sealed by red metal and yellow overseal.|Commercially sourced sterile normal saline will be provided as Placebo",null,"Participants receiving GSK3772847|Participants receiving placebo","\n\n * Participant must be at least 18 years of age inclusive, at the time of signing the informed consent.\n * Documented history of physician diagnosed moderate or severe asthma for >=12 months based on Guidelines and treated with inhaled corticosteroid (ICS) and long-acting beta-2-agonist (LABA) for at least 4 months (>=500 micrograms/day [Âµg/day]) fluticasone propionate or equivalent as defined in the guidelines.\n * Pre-bronchodilator FEV1 35-79% of predicted value for participant inclusive\n * FeNO >= 25 parts per billion (ppb) at Screening\n * ACQ-5 score >= 1.5 at Screening\n * Blood eosinophil >=300 cells/microliter at Screening\n * Evidence of allergic fungal airway disease like Fungal sensitization to any of the fungi Aspergillus fumigatus, Penicillium chrysogenum (notatum) at screening measured by serum-specific Immunoglobulin (Ig) E test. A history of exacerbations with at least 1 severe exacerbation (defined as requiring a minimum of 3 days of high-dose oral corticosteroids for asthma symptoms) in the previous 12 months.\n * Body weight within 50-150 kilogram (kg)\n * Both male and female gender. A female participant is eligible to participate if she is not pregnant not breastfeeding, Not a woman of childbearing potential (WOCBP) or A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 16 weeks after the last dose of study treatment.\n * Capable of giving signed informed consent\n\n","\n\n * Historical diagnosis of cystic fibrosis\n * Concurrent respiratory diseases: Presence of a known pre-existing, clinically important respiratory conditions (example pneumonia, pneumothorax, atelectasis segmental or larger, pulmonary fibrotic disease, bronchopulmonary dysplasia, chronic bronchitis, emphysema, chronic obstructive pulmonary disease, or other respiratory abnormalities) other than asthma or AFAD\n * Has a history of chronic or recurrent non-pulmonary infectious disease or ongoing non-pulmonary infection including, but not limited to, chronic renal infection, chronic chest infection, recurrent urinary tract infection (example, recurrent pyelonephritis, chronic non-remitting cystitis), or open, draining skin wound or an ulcer\n * Serious infection within 8 weeks of enrolment, including, but not limited to hepatitis, pneumonia, sepsis, or pyelonephritis; or has been hospitalized for an infection; or has been treated with IV antibiotics for an infection, within 8 weeks prior to the first administration of study drug.\n * Evidence of poorly controlled chronic medical conditions other than asthma, example, participants with known, pre-existing, clinically significant endocrine, autoimmune, metabolic, neurological, renal, cardiovascular, gastrointestinal, hepatic, and hematological or any other system abnormalities that are uncontrolled with standard treatment.\n * Cardiovascular disease: Clinically significant organic heart disease\n * Participants with a diagnosis of malignancy or in the process of investigation for a malignancy. Participants with carcinoma that have not been in complete remission for at least 5 years. Participants who have had carcinoma in situ of the cervix, squamous cell carcinoma and basal cell carcinoma of the skin would not be excluded based on the 5 year waiting period if the participant has been considered cured by treatment.\n * Eosinophilic diseases: Other conditions that could lead to elevated eosinophil such as hyper-eosinophilic syndromes. Participants with a known, pre-existing parasitic infestation within 6 months prior to Screening (Visit 1)\n * Prohibited medications is not permitted within the defined time intervals prior to Screening (Visit 1) and throughout the study.\n * Presence of hepatitis B surface antigen (HBsAg), positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study treatment.\n * A known immunodeficiency such as human immunodeficiency virus infection.\n * Hypersensitivity: significant allergies to humanized monoclonal antibodies or biologic or to any components of the formulation used in this study\n * Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear Ig A dermatosis, toxic epidermal necrolysis, and exfoliative dermatitis).\n * Clinically significant abnormality on 12-lead ECG assessment at screening (Visit 1). Site investigators will be provided with ECG over-read conducted by a centralized independent cardiologist, to assist in evaluation of participant eligibility.\n * Sinus bradycardia <45 beats per minute (bpm), sinus tachycardia >= 110 bpm, multifocal atrial tachycardia (wandering atrial pacemaker with rate >100bpm), evidence of Mobitz II second degree or third degree atrioventricular (AV) block, pathological Q waves (defined as wide [>0.04 seconds] and deep [>0.4 millivolts (mV) (4 millimeter [mm] with 10mm/mV setting)] or >25% of the height of the corresponding R wave, providing the R wave was >0.5mV [5mm with 10mm/mV setting], appearing in at least two contiguous leads, evidence of ventricular ectopic couplets, bigeminy, trigeminy or multifocal premature ventricular complexes, for participants without complete right bundle branch block: QTc for heart rate by Fridericia's formula QTc(F) >= 450 millisecond (msec) or an ECG that is unsuitable for QT measurements, for participants with complete right bundle branch block: QTc(F) >=480 msec or an ECG that is unsuitable for QT measurements, ST-T wave abnormalities, clinically significant conduction abnormalities and clinically significant arrhythmias.\n * Smoking history: current smokers or former smokers with a smoking history >= 10 pack years\n * History of alcohol or illegal substance abuse within 2 years prior to Screening (Visit1).\n * Participants at risk of non-compliance, or unable to comply with the study procedures. Participants who are unable to follow study instructions such as visit schedule and paper diary completion. Participants who have known evidence of lack of adherence to controller medication and/or ability to follow physician's recommendations. Any infirmity, disability, or geographic location that would limit compliance for scheduled visits.",{"$nulls":4},"Actual","2018-01-09","Actual","Anticipated","2019-07-02","Anticipated","2018-05-01","2018-01-03","2018-01-03","2018-05-08","No","Asthma Control Questionnaire\nAllergic fungal airway disease\nAsthma Quality of Life Questionnaire\nHolter monitoring\nAsthma","Interventional","Treatment","Parallel Assignment","Double (Participant, Investigator)","Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"No","No",{"$nulls":19},"Change from Baseline in blood eosinophils|Change from Baseline in fractional exhaled nitric oxide (FeNO)","Blood samples will be collected at indicated time points for the assessment of eosinophil|FeNO will be measured using a handheld electronic device","Baseline and up to Day 88","Serum concentrations of GSK3772847|Serum levels of free soluble suppressor of tumorigenicity 2 (ST2)|Serum levels of total soluble ST2|Number of participants with positive result of serum anti-GSK3772847 antibodies post dosing|Titers of serum anti-GSK3772847 antibodies post dosing|Change from Baseline in Asthma Control Questionnaire-5 (ACQ-5) absolute score at Weeks 2, 4, 8 and 12|Change from Baseline in Asthma Quality of Life Questionnaire (AQLQ) total and domain scores at Weeks 2, 4, 8 and 12|Number of responders to ACQ-5|Number of responders to AQLQ|Change from Baseline in forced expiratory volume in 1 second (FEV1)|Change from Baseline in forced vital capacity (FVC)|Number of participants with treatment emergent adverse events (AE) and serious AEs (SAE)|Number of participants with abnormal hematology parameters|Number of participants with abnormal clinical chemistry parameters|Number of participants with abnormal systolic blood pressure (SBP) and diastolic blood pressure (DBP)|Number of participants with abnormal heart rate|Number of participants with abnormal findings in Electrocardiogram (ECG)|Number of participants with abnormal 24-hour Holter findings","Blood samples will be collected at indicated time points for assessment of serum concentrations|Blood samples will be collected at indicated time points to measure free soluble ST2|Blood samples will be collected at indicated time points to measure total soluble ST2|Blood samples will be collected at indicated time points and anti-GSK3772847 antibodies will be assessed using a tiered approach.|ACQ-5 is a 5-item questionnaire that is a measure of the participant's asthma control. The five questions include about the frequency and/or severity of symptoms like nocturnal awakening, activity limitation, shortness of breath and wheeze. The score scales from zero (totally controlled) and 6 (severely uncontrolled)|AQLQ is 32 items four domains questionnaire used for evaluation of impact of asthma treatments on the quality of life of participants. The scores are evaluated from 1 (total impairment) and 7 (no impairment)|ACQ-5 is a 5 question tool used to measure attributes of asthma control and the score ranges from 0 to 6 where 0 is no impairment/limitation and 6 is total impairment/limitation. A responder to ACQ-5 will be defined as a participant who has a decrease from Baseline in ACQ-5 score of 0.5 or more.|AQLQ is a 32 items four domain questionnaire used to measure quality of life participants due to asthma treatment and the scores ranges from 1 to 7 where 1 indicates total impairment and 7 indicates no impairment. A responder to AQLQ will be defined as a participant who has an increase from Baseline in AQLQ score of 0.5 or more.|Spirometry assessment will include pre-bronchodilator FEV1|Spirometry assessment will include pre-bronchodilator FVC|An AE is any untoward medical occurrence in a clinical study participants, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that, at any dose may result in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment.|Laboratory assessment for hematology parameters will include Platelet count, hemoglobin, Red blood cell (RBC) count, hematocrit, Red blood cell distribution width (RDW), RBC indices like mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH) and mean corpuscular hemoglobin concentration (MCHC). White blood cell (WBC) count with differential will include neutrophils, lymphocytes, monocytes, eosinophils and basophils.|Laboratory assessment for clinical chemistry parameters will include blood urea nitrogen (BUN), potassium, calcium, sodium, creatinine, non-fasting glucose, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline phosphate, Gamma-glutamyl transferase (GGT), albumin, phosphorus, carbon dioxide, total protein, creatine phosphokinase (CPK), total and direct bilirubin|Blood pressure will be measured in supine position after 5 minutes rest|Heart rate will be measured in supine position after 5 minutes rest|Single 12-lead ECG will be obtained using an ECG machine that automatically measures heart rate, PR, QRS, QT, and QT interval corrected for heart rate (QTc) and ventricular rate|Holter assessment will be used for quantitative assessment of abnormal rhythm events. Holter monitor will be placed 30-60 minutes prior to dosing.","Day 1 post-end of infusion, Day 15, Pre-dose on Day 29, Pre-dose and post-dose on Day 57, Day 85 and Day 169|Day 1 Pre and post-dose; Day 15; Day 29 Post dose; Day 57 pre and post dose; Day 85, Day 169|Up to Day 172|Baseline and at Weeks 2, 4, 8 and 12|Up to Day 88|Day 1","GSKClinicalSupportHD@gsk.com","US GSK Clinical Trials Call Center","877-379-3718","Montpellier Cedex 5, France, 34295|Leicester, Leicestershire, United Kingdom, Le3 9Qp|Birmingham, United Kingdom, B9 5Ss",null,"France|United Kingdom","Gsk Investigational Site|, Leicestershire Gsk Investigational Site",{"$nulls":3},"GSK Clinical Trials","2018-05-08","2020-05-25T16:35:49.080","2020-05-26T17:10:42.972","NCT03393806"]
["5ecbf3e511702c1b1b9169fc","NCT03393806","2018-05-22","GlaxoSmithKline","GSK","Recruiting","Repeat Dose Study of GSK3772847 in Participants With Moderate to Severe Asthma With Allergic Fungal Airway Disease (AFAD)","Gsk-3772847",null,"Yes","['Gsk-3772847']","Unknown",null,"Phase 2",2,46,"Anticipated","2018-04-18","2019-04-09",{"$nulls":5},"This study is multicenter, double-blinded parallel group design, where participants with moderate to severe asthma with AFAD will be enrolled. Participants will receive three doses of 10 milligrams/kilogram (mg/kg) of GSK3772847 every 4 Weeks versus placebo along with standard of care. Participants will be randomized in 1:1 ratio to receive either 10 mg/kg GSK3772847 intravenously (IV) or matching placebo IV. Participants will receive study treatment on Week 0 (Day 1), Week 4 and Week 8. The total duration of the study will be 28 Weeks and approximately 46 participants will be randomized.",null,"A Double Blind (Sponsor Open) Placebo-controlled, Stratified, Parallel Group Study to Evaluate the Efficacy and Safety of Repeat Doses of GSK3772847 in Participants With Moderate to Severe Asthma With Allergic Fungal Airway Disease (AFAD)",207972,"Asthma","Asthma","Bronchial Diseases","Respiratory","Experimental|Placebo Comparator","Participants receiving GSK3772847|Participants receiving placebo","Participants will be randomized to receive GSK3772847 as IV infusion. Participants will receive three doses ( Day 1, Day 29 and Day 57) of GSK3772847 every 4 weeks|Participants will be randomized to receive matching placebo as IV infusion","Drug","GSK3772847|Placebo","GSK3772847 will be available as 100 mg/vial, white to yellow, uniform lyophilized cake in a 5 milliliter (mL) clear glass vial with closure sealed by red metal and yellow overseal.|Commercially sourced sterile normal saline will be provided as Placebo",null,"Participants receiving GSK3772847|Participants receiving placebo","\n\n * Participant must be at least 18 years of age inclusive, at the time of signing the informed consent.\n * Documented history of physician diagnosed moderate or severe asthma for >=12 months based on Guidelines and treated with inhaled corticosteroid (ICS) and long-acting beta-2-agonist (LABA) for at least 4 months (>=500 micrograms/day [Âµg/day]) fluticasone propionate or equivalent as defined in the guidelines.\n * Pre-bronchodilator FEV1 35-79% of predicted value for participant inclusive\n * FeNO >= 25 parts per billion (ppb) at Screening\n * ACQ-5 score >= 1.5 at Screening\n * Blood eosinophil >=300 cells/microliter at Screening\n * Evidence of allergic fungal airway disease like Fungal sensitization to any of the fungi Aspergillus fumigatus, Penicillium chrysogenum (notatum) at screening measured by serum-specific Immunoglobulin (Ig) E test. A history of exacerbations with at least 1 severe exacerbation (defined as requiring a minimum of 3 days of high-dose oral corticosteroids for asthma symptoms) in the previous 12 months.\n * Body weight within 50-150 kilogram (kg)\n * Both male and female gender. A female participant is eligible to participate if she is not pregnant not breastfeeding, Not a woman of childbearing potential (WOCBP) or A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 16 weeks after the last dose of study treatment.\n * Capable of giving signed informed consent\n\n","\n\n * Historical diagnosis of cystic fibrosis\n * Concurrent respiratory diseases: Presence of a known pre-existing, clinically important respiratory conditions (example pneumonia, pneumothorax, atelectasis segmental or larger, pulmonary fibrotic disease, bronchopulmonary dysplasia, chronic bronchitis, emphysema, chronic obstructive pulmonary disease, or other respiratory abnormalities) other than asthma or AFAD\n * Has a history of chronic or recurrent non-pulmonary infectious disease or ongoing non-pulmonary infection including, but not limited to, chronic renal infection, chronic chest infection, recurrent urinary tract infection (example, recurrent pyelonephritis, chronic non-remitting cystitis), or open, draining skin wound or an ulcer\n * Serious infection within 8 weeks of enrolment, including, but not limited to hepatitis, pneumonia, sepsis, or pyelonephritis; or has been hospitalized for an infection; or has been treated with IV antibiotics for an infection, within 8 weeks prior to the first administration of study drug.\n * Evidence of poorly controlled chronic medical conditions other than asthma, example, participants with known, pre-existing, clinically significant endocrine, autoimmune, metabolic, neurological, renal, cardiovascular, gastrointestinal, hepatic, and hematological or any other system abnormalities that are uncontrolled with standard treatment.\n * Cardiovascular disease: Clinically significant organic heart disease\n * Participants with a diagnosis of malignancy or in the process of investigation for a malignancy. Participants with carcinoma that have not been in complete remission for at least 5 years. Participants who have had carcinoma in situ of the cervix, squamous cell carcinoma and basal cell carcinoma of the skin would not be excluded based on the 5 year waiting period if the participant has been considered cured by treatment.\n * Eosinophilic diseases: Other conditions that could lead to elevated eosinophil such as hyper-eosinophilic syndromes. Participants with a known, pre-existing parasitic infestation within 6 months prior to Screening (Visit 1)\n * Prohibited medications is not permitted within the defined time intervals prior to Screening (Visit 1) and throughout the study.\n * Presence of hepatitis B surface antigen (HBsAg), positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study treatment.\n * A known immunodeficiency such as human immunodeficiency virus infection.\n * Hypersensitivity: significant allergies to humanized monoclonal antibodies or biologic or to any components of the formulation used in this study\n * Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear Ig A dermatosis, toxic epidermal necrolysis, and exfoliative dermatitis).\n * Clinically significant abnormality on 12-lead ECG assessment at screening (Visit 1). Site investigators will be provided with ECG over-read conducted by a centralized independent cardiologist, to assist in evaluation of participant eligibility.\n * Sinus bradycardia <45 beats per minute (bpm), sinus tachycardia >= 110 bpm, multifocal atrial tachycardia (wandering atrial pacemaker with rate >100bpm), evidence of Mobitz II second degree or third degree atrioventricular (AV) block, pathological Q waves (defined as wide [>0.04 seconds] and deep [>0.4 millivolts (mV) (4 millimeter [mm] with 10mm/mV setting)] or >25% of the height of the corresponding R wave, providing the R wave was >0.5mV [5mm with 10mm/mV setting], appearing in at least two contiguous leads, evidence of ventricular ectopic couplets, bigeminy, trigeminy or multifocal premature ventricular complexes, for participants without complete right bundle branch block: QTc for heart rate by Fridericia's formula QTc(F) >= 450 millisecond (msec) or an ECG that is unsuitable for QT measurements, for participants with complete right bundle branch block: QTc(F) >=480 msec or an ECG that is unsuitable for QT measurements, ST-T wave abnormalities, clinically significant conduction abnormalities and clinically significant arrhythmias.\n * Smoking history: current smokers or former smokers with a smoking history >= 10 pack years\n * History of alcohol or illegal substance abuse within 2 years prior to Screening (Visit1).\n * Participants at risk of non-compliance, or unable to comply with the study procedures. Participants who are unable to follow study instructions such as visit schedule and paper diary completion. Participants who have known evidence of lack of adherence to controller medication and/or ability to follow physician's recommendations. Any infirmity, disability, or geographic location that would limit compliance for scheduled visits.",{"$nulls":4},"Actual","2018-01-09","Actual","Anticipated","2019-07-02","Anticipated","2018-05-01","2018-01-03","2018-01-03","2018-05-18","No","Asthma Control Questionnaire\nAllergic fungal airway disease\nAsthma Quality of Life Questionnaire\nHolter monitoring\nAsthma","Interventional","Treatment","Parallel Assignment","Double (Participant, Investigator)","Randomized","18 Years",null,"All",null,"No","Yes\nIPD for this study will be made available via the Clinical Study Data Request site.",{"$nulls":3},"No","No",{"$nulls":19},"Change from Baseline in blood eosinophils|Change from Baseline in fractional exhaled nitric oxide (FeNO)","Blood samples will be collected at indicated time points for the assessment of eosinophil|FeNO will be measured using a handheld electronic device","Baseline and up to Day 88","Serum concentrations of GSK3772847|Serum levels of free soluble suppressor of tumorigenicity 2 (ST2)|Serum levels of total soluble ST2|Number of participants with positive result of serum anti-GSK3772847 antibodies post dosing|Titers of serum anti-GSK3772847 antibodies post dosing|Change from Baseline in Asthma Control Questionnaire-5 (ACQ-5) absolute score at Weeks 2, 4, 8 and 12|Change from Baseline in Asthma Quality of Life Questionnaire (AQLQ) total and domain scores at Weeks 2, 4, 8 and 12|Number of responders to ACQ-5|Number of responders to AQLQ|Change from Baseline in forced expiratory volume in 1 second (FEV1)|Change from Baseline in forced vital capacity (FVC)|Number of participants with treatment emergent adverse events (AE) and serious AEs (SAE)|Number of participants with abnormal hematology parameters|Number of participants with abnormal clinical chemistry parameters|Number of participants with abnormal systolic blood pressure (SBP) and diastolic blood pressure (DBP)|Number of participants with abnormal heart rate|Number of participants with abnormal findings in Electrocardiogram (ECG)|Number of participants with abnormal 24-hour Holter findings","Blood samples will be collected at indicated time points for assessment of serum concentrations|Blood samples will be collected at indicated time points to measure free soluble ST2|Blood samples will be collected at indicated time points to measure total soluble ST2|Blood samples will be collected at indicated time points and anti-GSK3772847 antibodies will be assessed using a tiered approach.|ACQ-5 is a 5-item questionnaire that is a measure of the participant's asthma control. The five questions include about the frequency and/or severity of symptoms like nocturnal awakening, activity limitation, shortness of breath and wheeze. The score scales from zero (totally controlled) and 6 (severely uncontrolled)|AQLQ is 32 items four domains questionnaire used for evaluation of impact of asthma treatments on the quality of life of participants. The scores are evaluated from 1 (total impairment) and 7 (no impairment)|ACQ-5 is a 5 question tool used to measure attributes of asthma control and the score ranges from 0 to 6 where 0 is no impairment/limitation and 6 is total impairment/limitation. A responder to ACQ-5 will be defined as a participant who has a decrease from Baseline in ACQ-5 score of 0.5 or more.|AQLQ is a 32 items four domain questionnaire used to measure quality of life participants due to asthma treatment and the scores ranges from 1 to 7 where 1 indicates total impairment and 7 indicates no impairment. A responder to AQLQ will be defined as a participant who has an increase from Baseline in AQLQ score of 0.5 or more.|Spirometry assessment will include pre-bronchodilator FEV1|Spirometry assessment will include pre-bronchodilator FVC|An AE is any untoward medical occurrence in a clinical study participants, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that, at any dose may result in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment.|Laboratory assessment for hematology parameters will include Platelet count, hemoglobin, Red blood cell (RBC) count, hematocrit, Red blood cell distribution width (RDW), RBC indices like mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH) and mean corpuscular hemoglobin concentration (MCHC). White blood cell (WBC) count with differential will include neutrophils, lymphocytes, monocytes, eosinophils and basophils.|Laboratory assessment for clinical chemistry parameters will include blood urea nitrogen (BUN), potassium, calcium, sodium, creatinine, non-fasting glucose, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline phosphate, Gamma-glutamyl transferase (GGT), albumin, phosphorus, carbon dioxide, total protein, creatine phosphokinase (CPK), total and direct bilirubin|Blood pressure will be measured in supine position after 5 minutes rest|Heart rate will be measured in supine position after 5 minutes rest|Single 12-lead ECG will be obtained using an ECG machine that automatically measures heart rate, PR, QRS, QT, and QT interval corrected for heart rate (QTc) and ventricular rate|Holter assessment will be used for quantitative assessment of abnormal rhythm events. Holter monitor will be placed 30-60 minutes prior to dosing.","Day 1 post-end of infusion, Day 15, Pre-dose on Day 29, Pre-dose and post-dose on Day 57, Day 85 and Day 169|Day 1 Pre and post-dose; Day 15; Day 29 Post dose; Day 57 pre and post dose; Day 85, Day 169|Up to Day 172|Baseline and at Weeks 2, 4, 8 and 12|Up to Day 88|Day 1","GSKClinicalSupportHD@gsk.com","US GSK Clinical Trials Call Center","877-379-3718","Montpellier Cedex 5, France, 34295|Leicester, Leicestershire, United Kingdom, Le3 9Qp|Birmingham, United Kingdom, B9 5Ss",null,"France|United Kingdom","Gsk Investigational Site|, Leicestershire Gsk Investigational Site",{"$nulls":3},"GSK Clinical Trials","2018-05-18","2020-05-25T16:35:49.100","2020-05-26T17:10:42.972","NCT03393806"]
["5ecbf3e5fe30261b1a0481eb","NCT03393806","2018-06-01","GlaxoSmithKline","GSK","Recruiting","Repeat Dose Study of GSK3772847 in Participants With Moderate to Severe Asthma With Allergic Fungal Airway Disease (AFAD)","Gsk-3772847",null,"Yes","['Gsk-3772847']","Unknown",null,"Phase 2",2,46,"Anticipated","2018-04-18","2019-04-09",{"$nulls":5},"This study is multicenter, double-blinded parallel group design, where participants with moderate to severe asthma with AFAD will be enrolled. Participants will receive three doses of 10 milligrams/kilogram (mg/kg) of GSK3772847 every 4 Weeks versus placebo along with standard of care. Participants will be randomized in 1:1 ratio to receive either 10 mg/kg GSK3772847 intravenously (IV) or matching placebo IV. Participants will receive study treatment on Week 0 (Day 1), Week 4 and Week 8. The total duration of the study will be 28 Weeks and approximately 46 participants will be randomized.",null,"A Double Blind (Sponsor Open) Placebo-controlled, Stratified, Parallel Group Study to Evaluate the Efficacy and Safety of Repeat Doses of GSK3772847 in Participants With Moderate to Severe Asthma With Allergic Fungal Airway Disease (AFAD)",207972,"Asthma","Asthma","Bronchial Diseases","Respiratory","Experimental|Placebo Comparator","Participants receiving GSK3772847|Participants receiving placebo","Participants will be randomized to receive GSK3772847 as IV infusion. Participants will receive three doses ( Day 1, Day 29 and Day 57) of GSK3772847 every 4 weeks|Participants will be randomized to receive matching placebo as IV infusion","Drug","GSK3772847|Placebo","GSK3772847 will be available as 100 mg/vial, white to yellow, uniform lyophilized cake in a 5 milliliter (mL) clear glass vial with closure sealed by red metal and yellow overseal.|Commercially sourced sterile normal saline will be provided as Placebo",null,"Participants receiving GSK3772847|Participants receiving placebo","\n\n * Participant must be at least 18 years of age inclusive, at the time of signing the informed consent.\n * Documented history of physician diagnosed moderate or severe asthma for >=12 months based on Guidelines and treated with inhaled corticosteroid (ICS) and long-acting beta-2-agonist (LABA) for at least 4 months (>=500 micrograms/day [Âµg/day]) fluticasone propionate or equivalent as defined in the guidelines.\n * Pre-bronchodilator FEV1 35-79% of predicted value for participant inclusive\n * FeNO >= 25 parts per billion (ppb) at Screening\n * ACQ-5 score >= 1.5 at Screening\n * Blood eosinophil >=300 cells/microliter at Screening\n * Evidence of allergic fungal airway disease like Fungal sensitization to any of the fungi Aspergillus fumigatus, Penicillium chrysogenum (notatum) at screening measured by serum-specific Immunoglobulin (Ig) E test. A history of exacerbations with at least 1 severe exacerbation (defined as requiring a minimum of 3 days of high-dose oral corticosteroids for asthma symptoms) in the previous 12 months.\n * Body weight within 50-150 kilogram (kg)\n * Both male and female gender. A female participant is eligible to participate if she is not pregnant not breastfeeding, Not a woman of childbearing potential (WOCBP) or A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 16 weeks after the last dose of study treatment.\n * Capable of giving signed informed consent\n\n","\n\n * Historical diagnosis of cystic fibrosis\n * Concurrent respiratory diseases: Presence of a known pre-existing, clinically important respiratory conditions (example pneumonia, pneumothorax, atelectasis segmental or larger, pulmonary fibrotic disease, bronchopulmonary dysplasia, chronic bronchitis, emphysema, chronic obstructive pulmonary disease, or other respiratory abnormalities) other than asthma or AFAD\n * Has a history of chronic or recurrent non-pulmonary infectious disease or ongoing non-pulmonary infection including, but not limited to, chronic renal infection, chronic chest infection, recurrent urinary tract infection (example, recurrent pyelonephritis, chronic non-remitting cystitis), or open, draining skin wound or an ulcer\n * Serious infection within 8 weeks of enrolment, including, but not limited to hepatitis, pneumonia, sepsis, or pyelonephritis; or has been hospitalized for an infection; or has been treated with IV antibiotics for an infection, within 8 weeks prior to the first administration of study drug.\n * Evidence of poorly controlled chronic medical conditions other than asthma, example, participants with known, pre-existing, clinically significant endocrine, autoimmune, metabolic, neurological, renal, cardiovascular, gastrointestinal, hepatic, and hematological or any other system abnormalities that are uncontrolled with standard treatment.\n * Cardiovascular disease: Clinically significant organic heart disease\n * Participants with a diagnosis of malignancy or in the process of investigation for a malignancy. Participants with carcinoma that have not been in complete remission for at least 5 years. Participants who have had carcinoma in situ of the cervix, squamous cell carcinoma and basal cell carcinoma of the skin would not be excluded based on the 5 year waiting period if the participant has been considered cured by treatment.\n * Eosinophilic diseases: Other conditions that could lead to elevated eosinophil such as hyper-eosinophilic syndromes. Participants with a known, pre-existing parasitic infestation within 6 months prior to Screening (Visit 1)\n * Prohibited medications is not permitted within the defined time intervals prior to Screening (Visit 1) and throughout the study.\n * Presence of hepatitis B surface antigen (HBsAg), positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study treatment.\n * A known immunodeficiency such as human immunodeficiency virus infection.\n * Hypersensitivity: significant allergies to humanized monoclonal antibodies or biologic or to any components of the formulation used in this study\n * Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear Ig A dermatosis, toxic epidermal necrolysis, and exfoliative dermatitis).\n * Clinically significant abnormality on 12-lead ECG assessment at screening (Visit 1). Site investigators will be provided with ECG over-read conducted by a centralized independent cardiologist, to assist in evaluation of participant eligibility.\n * Sinus bradycardia <45 beats per minute (bpm), sinus tachycardia >= 110 bpm, multifocal atrial tachycardia (wandering atrial pacemaker with rate >100bpm), evidence of Mobitz II second degree or third degree atrioventricular (AV) block, pathological Q waves (defined as wide [>0.04 seconds] and deep [>0.4 millivolts (mV) (4 millimeter [mm] with 10mm/mV setting)] or >25% of the height of the corresponding R wave, providing the R wave was >0.5mV [5mm with 10mm/mV setting], appearing in at least two contiguous leads, evidence of ventricular ectopic couplets, bigeminy, trigeminy or multifocal premature ventricular complexes, for participants without complete right bundle branch block: QTc for heart rate by Fridericia's formula QTc(F) >= 450 millisecond (msec) or an ECG that is unsuitable for QT measurements, for participants with complete right bundle branch block: QTc(F) >=480 msec or an ECG that is unsuitable for QT measurements, ST-T wave abnormalities, clinically significant conduction abnormalities and clinically significant arrhythmias.\n * Smoking history: current smokers or former smokers with a smoking history >= 10 pack years\n * History of alcohol or illegal substance abuse within 2 years prior to Screening (Visit1).\n * Participants at risk of non-compliance, or unable to comply with the study procedures. Participants who are unable to follow study instructions such as visit schedule and paper diary completion. Participants who have known evidence of lack of adherence to controller medication and/or ability to follow physician's recommendations. Any infirmity, disability, or geographic location that would limit compliance for scheduled visits.",{"$nulls":4},"Actual","2018-01-09","Actual","Anticipated","2019-07-02","Anticipated","2018-05-01","2018-01-03","2018-01-03","2018-05-31","No","Asthma Control Questionnaire\nAllergic fungal airway disease\nAsthma Quality of Life Questionnaire\nHolter monitoring\nAsthma","Interventional","Treatment","Parallel Assignment","Double (Participant, Investigator)","Randomized","18 Years",null,"All",null,"No","Yes\nIPD for this study will be made available via the Clinical Study Data Request site.",{"$nulls":3},"No","No",{"$nulls":19},"Change from Baseline in blood eosinophils|Change from Baseline in fractional exhaled nitric oxide (FeNO)","Blood samples will be collected at indicated time points for the assessment of eosinophil|FeNO will be measured using a handheld electronic device","Baseline and up to Day 88","Serum concentrations of GSK3772847|Serum levels of free soluble suppressor of tumorigenicity 2 (ST2)|Serum levels of total soluble ST2|Number of participants with positive result of serum anti-GSK3772847 antibodies post dosing|Titers of serum anti-GSK3772847 antibodies post dosing|Change from Baseline in Asthma Control Questionnaire-5 (ACQ-5) absolute score at Weeks 2, 4, 8 and 12|Change from Baseline in Asthma Quality of Life Questionnaire (AQLQ) total and domain scores at Weeks 2, 4, 8 and 12|Number of responders to ACQ-5|Number of responders to AQLQ|Change from Baseline in forced expiratory volume in 1 second (FEV1)|Change from Baseline in forced vital capacity (FVC)|Number of participants with treatment emergent adverse events (AE) and serious AEs (SAE)|Number of participants with abnormal hematology parameters|Number of participants with abnormal clinical chemistry parameters|Number of participants with abnormal systolic blood pressure (SBP) and diastolic blood pressure (DBP)|Number of participants with abnormal heart rate|Number of participants with abnormal findings in Electrocardiogram (ECG)|Number of participants with abnormal 24-hour Holter findings","Blood samples will be collected at indicated time points for assessment of serum concentrations|Blood samples will be collected at indicated time points to measure free soluble ST2|Blood samples will be collected at indicated time points to measure total soluble ST2|Blood samples will be collected at indicated time points and anti-GSK3772847 antibodies will be assessed using a tiered approach.|ACQ-5 is a 5-item questionnaire that is a measure of the participant's asthma control. The five questions include about the frequency and/or severity of symptoms like nocturnal awakening, activity limitation, shortness of breath and wheeze. The score scales from zero (totally controlled) and 6 (severely uncontrolled)|AQLQ is 32 items four domains questionnaire used for evaluation of impact of asthma treatments on the quality of life of participants. The scores are evaluated from 1 (total impairment) and 7 (no impairment)|ACQ-5 is a 5 question tool used to measure attributes of asthma control and the score ranges from 0 to 6 where 0 is no impairment/limitation and 6 is total impairment/limitation. A responder to ACQ-5 will be defined as a participant who has a decrease from Baseline in ACQ-5 score of 0.5 or more.|AQLQ is a 32 items four domain questionnaire used to measure quality of life participants due to asthma treatment and the scores ranges from 1 to 7 where 1 indicates total impairment and 7 indicates no impairment. A responder to AQLQ will be defined as a participant who has an increase from Baseline in AQLQ score of 0.5 or more.|Spirometry assessment will include pre-bronchodilator FEV1|Spirometry assessment will include pre-bronchodilator FVC|An AE is any untoward medical occurrence in a clinical study participants, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that, at any dose may result in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment.|Laboratory assessment for hematology parameters will include Platelet count, hemoglobin, Red blood cell (RBC) count, hematocrit, Red blood cell distribution width (RDW), RBC indices like mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH) and mean corpuscular hemoglobin concentration (MCHC). White blood cell (WBC) count with differential will include neutrophils, lymphocytes, monocytes, eosinophils and basophils.|Laboratory assessment for clinical chemistry parameters will include blood urea nitrogen (BUN), potassium, calcium, sodium, creatinine, non-fasting glucose, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline phosphate, Gamma-glutamyl transferase (GGT), albumin, phosphorus, carbon dioxide, total protein, creatine phosphokinase (CPK), total and direct bilirubin|Blood pressure will be measured in supine position after 5 minutes rest|Heart rate will be measured in supine position after 5 minutes rest|Single 12-lead ECG will be obtained using an ECG machine that automatically measures heart rate, PR, QRS, QT, and QT interval corrected for heart rate (QTc) and ventricular rate|Holter assessment will be used for quantitative assessment of abnormal rhythm events. Holter monitor will be placed 30-60 minutes prior to dosing.","Day 1 post-end of infusion, Day 15, Pre-dose on Day 29, Pre-dose and post-dose on Day 57, Day 85 and Day 169|Day 1 Pre and post-dose; Day 15; Day 29 Post dose; Day 57 pre and post dose; Day 85, Day 169|Up to Day 172|Baseline and at Weeks 2, 4, 8 and 12|Up to Day 88|Day 1","GSKClinicalSupportHD@gsk.com","US GSK Clinical Trials Call Center","877-379-3718","Montpellier Cedex 5, France, 34295|Leicester, Leicestershire, United Kingdom, Le3 9Qp|Birmingham, United Kingdom, B9 5Ss",null,"France|United Kingdom","Gsk Investigational Site|, Leicestershire Gsk Investigational Site",{"$nulls":3},"GSK Clinical Trials","2018-05-31","2020-05-25T16:35:49.199","2020-05-26T17:10:42.972","NCT03393806"]
["5ecbf3e5fe30261b1a0481ec","NCT03393806","2018-06-08","GlaxoSmithKline","GSK","Recruiting","Repeat Dose Study of GSK3772847 in Participants With Moderate to Severe Asthma With Allergic Fungal Airway Disease (AFAD)","Gsk-3772847",null,"Yes","['Gsk-3772847']","Unknown",null,"Phase 2",2,46,"Anticipated","2018-04-18","2019-04-09",{"$nulls":5},"This study is multicenter, double-blinded parallel group design, where participants with moderate to severe asthma with AFAD will be enrolled. Participants will receive three doses of 10 milligrams/kilogram (mg/kg) of GSK3772847 every 4 Weeks versus placebo along with standard of care. Participants will be randomized in 1:1 ratio to receive either 10 mg/kg GSK3772847 intravenously (IV) or matching placebo IV. Participants will receive study treatment on Week 0 (Day 1), Week 4 and Week 8. The total duration of the study will be 28 Weeks and approximately 46 participants will be randomized.",null,"A Double Blind (Sponsor Open) Placebo-controlled, Stratified, Parallel Group Study to Evaluate the Efficacy and Safety of Repeat Doses of GSK3772847 in Participants With Moderate to Severe Asthma With Allergic Fungal Airway Disease (AFAD)",207972,"Asthma","Asthma","Bronchial Diseases","Respiratory","Experimental|Placebo Comparator","Participants receiving GSK3772847|Participants receiving placebo","Participants will be randomized to receive GSK3772847 as IV infusion. Participants will receive three doses ( Day 1, Day 29 and Day 57) of GSK3772847 every 4 weeks|Participants will be randomized to receive matching placebo as IV infusion","Drug","GSK3772847|Placebo","GSK3772847 will be available as 100 mg/vial, white to yellow, uniform lyophilized cake in a 5 milliliter (mL) clear glass vial with closure sealed by red metal and yellow overseal.|Commercially sourced sterile normal saline will be provided as Placebo",null,"Participants receiving GSK3772847|Participants receiving placebo","\n\n * Participant must be at least 18 years of age inclusive, at the time of signing the informed consent.\n * Documented history of physician diagnosed moderate or severe asthma for >=12 months based on Guidelines and treated with inhaled corticosteroid (ICS) and long-acting beta-2-agonist (LABA) for at least 4 months (>=500 micrograms/day [Âµg/day]) fluticasone propionate or equivalent as defined in the guidelines.\n * Pre-bronchodilator FEV1 35-79% of predicted value for participant inclusive\n * FeNO >= 25 parts per billion (ppb) at Screening\n * ACQ-5 score >= 1.5 at Screening\n * Blood eosinophil >=300 cells/microliter at Screening\n * Evidence of allergic fungal airway disease like Fungal sensitization to any of the fungi Aspergillus fumigatus, Penicillium chrysogenum (notatum) at screening measured by serum-specific Immunoglobulin (Ig) E test. A history of exacerbations with at least 1 severe exacerbation (defined as requiring a minimum of 3 days of high-dose oral corticosteroids for asthma symptoms) in the previous 12 months.\n * Body weight within 50-150 kilogram (kg)\n * Both male and female gender. A female participant is eligible to participate if she is not pregnant not breastfeeding, Not a woman of childbearing potential (WOCBP) or A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 16 weeks after the last dose of study treatment.\n * Capable of giving signed informed consent\n\n","\n\n * Historical diagnosis of cystic fibrosis\n * Concurrent respiratory diseases: Presence of a known pre-existing, clinically important respiratory conditions (example pneumonia, pneumothorax, atelectasis segmental or larger, pulmonary fibrotic disease, bronchopulmonary dysplasia, chronic bronchitis, emphysema, chronic obstructive pulmonary disease, or other respiratory abnormalities) other than asthma or AFAD\n * Has a history of chronic or recurrent non-pulmonary infectious disease or ongoing non-pulmonary infection including, but not limited to, chronic renal infection, chronic chest infection, recurrent urinary tract infection (example, recurrent pyelonephritis, chronic non-remitting cystitis), or open, draining skin wound or an ulcer\n * Serious infection within 8 weeks of enrolment, including, but not limited to hepatitis, pneumonia, sepsis, or pyelonephritis; or has been hospitalized for an infection; or has been treated with IV antibiotics for an infection, within 8 weeks prior to the first administration of study drug.\n * Evidence of poorly controlled chronic medical conditions other than asthma, example, participants with known, pre-existing, clinically significant endocrine, autoimmune, metabolic, neurological, renal, cardiovascular, gastrointestinal, hepatic, and hematological or any other system abnormalities that are uncontrolled with standard treatment.\n * Cardiovascular disease: Clinically significant organic heart disease\n * Participants with a diagnosis of malignancy or in the process of investigation for a malignancy. Participants with carcinoma that have not been in complete remission for at least 5 years. Participants who have had carcinoma in situ of the cervix, squamous cell carcinoma and basal cell carcinoma of the skin would not be excluded based on the 5 year waiting period if the participant has been considered cured by treatment.\n * Eosinophilic diseases: Other conditions that could lead to elevated eosinophil such as hyper-eosinophilic syndromes. Participants with a known, pre-existing parasitic infestation within 6 months prior to Screening (Visit 1)\n * Prohibited medications is not permitted within the defined time intervals prior to Screening (Visit 1) and throughout the study.\n * Presence of hepatitis B surface antigen (HBsAg), positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study treatment.\n * A known immunodeficiency such as human immunodeficiency virus infection.\n * Hypersensitivity: significant allergies to humanized monoclonal antibodies or biologic or to any components of the formulation used in this study\n * Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear Ig A dermatosis, toxic epidermal necrolysis, and exfoliative dermatitis).\n * Clinically significant abnormality on 12-lead ECG assessment at screening (Visit 1). Site investigators will be provided with ECG over-read conducted by a centralized independent cardiologist, to assist in evaluation of participant eligibility.\n * Sinus bradycardia <45 beats per minute (bpm), sinus tachycardia >= 110 bpm, multifocal atrial tachycardia (wandering atrial pacemaker with rate >100bpm), evidence of Mobitz II second degree or third degree atrioventricular (AV) block, pathological Q waves (defined as wide [>0.04 seconds] and deep [>0.4 millivolts (mV) (4 millimeter [mm] with 10mm/mV setting)] or >25% of the height of the corresponding R wave, providing the R wave was >0.5mV [5mm with 10mm/mV setting], appearing in at least two contiguous leads, evidence of ventricular ectopic couplets, bigeminy, trigeminy or multifocal premature ventricular complexes, for participants without complete right bundle branch block: QTc for heart rate by Fridericia's formula QTc(F) >= 450 millisecond (msec) or an ECG that is unsuitable for QT measurements, for participants with complete right bundle branch block: QTc(F) >=480 msec or an ECG that is unsuitable for QT measurements, ST-T wave abnormalities, clinically significant conduction abnormalities and clinically significant arrhythmias.\n * Smoking history: current smokers or former smokers with a smoking history >= 10 pack years\n * History of alcohol or illegal substance abuse within 2 years prior to Screening (Visit1).\n * Participants at risk of non-compliance, or unable to comply with the study procedures. Participants who are unable to follow study instructions such as visit schedule and paper diary completion. Participants who have known evidence of lack of adherence to controller medication and/or ability to follow physician's recommendations. Any infirmity, disability, or geographic location that would limit compliance for scheduled visits.",{"$nulls":4},"Actual","2018-01-09","Actual","Anticipated","2019-07-02","Anticipated","2018-06-01","2018-01-03","2018-01-03","2018-06-07","No","Asthma Control Questionnaire\nAllergic fungal airway disease\nAsthma Quality of Life Questionnaire\nHolter monitoring\nAsthma","Interventional","Treatment","Parallel Assignment","Double (Participant, Investigator)","Randomized","18 Years",null,"All",null,"No","Yes\nIPD for this study will be made available via the Clinical Study Data Request site.",{"$nulls":3},"No","No",{"$nulls":19},"Change from Baseline in blood eosinophils|Change from Baseline in fractional exhaled nitric oxide (FeNO)","Blood samples will be collected at indicated time points for the assessment of eosinophil|FeNO will be measured using a handheld electronic device","Baseline and up to Day 88","Serum concentrations of GSK3772847|Serum levels of free soluble suppressor of tumorigenicity 2 (ST2)|Serum levels of total soluble ST2|Number of participants with positive result of serum anti-GSK3772847 antibodies post dosing|Titers of serum anti-GSK3772847 antibodies post dosing|Change from Baseline in Asthma Control Questionnaire-5 (ACQ-5) absolute score at Weeks 2, 4, 8 and 12|Change from Baseline in Asthma Quality of Life Questionnaire (AQLQ) total and domain scores at Weeks 2, 4, 8 and 12|Number of responders to ACQ-5|Number of responders to AQLQ|Change from Baseline in forced expiratory volume in 1 second (FEV1)|Change from Baseline in forced vital capacity (FVC)|Number of participants with treatment emergent adverse events (AE) and serious AEs (SAE)|Number of participants with abnormal hematology parameters|Number of participants with abnormal clinical chemistry parameters|Number of participants with abnormal systolic blood pressure (SBP) and diastolic blood pressure (DBP)|Number of participants with abnormal heart rate|Number of participants with abnormal findings in Electrocardiogram (ECG)|Number of participants with abnormal 24-hour Holter findings","Blood samples will be collected at indicated time points for assessment of serum concentrations|Blood samples will be collected at indicated time points to measure free soluble ST2|Blood samples will be collected at indicated time points to measure total soluble ST2|Blood samples will be collected at indicated time points and anti-GSK3772847 antibodies will be assessed using a tiered approach.|ACQ-5 is a 5-item questionnaire that is a measure of the participant's asthma control. The five questions include about the frequency and/or severity of symptoms like nocturnal awakening, activity limitation, shortness of breath and wheeze. The score scales from zero (totally controlled) and 6 (severely uncontrolled)|AQLQ is 32 items four domains questionnaire used for evaluation of impact of asthma treatments on the quality of life of participants. The scores are evaluated from 1 (total impairment) and 7 (no impairment)|ACQ-5 is a 5 question tool used to measure attributes of asthma control and the score ranges from 0 to 6 where 0 is no impairment/limitation and 6 is total impairment/limitation. A responder to ACQ-5 will be defined as a participant who has a decrease from Baseline in ACQ-5 score of 0.5 or more.|AQLQ is a 32 items four domain questionnaire used to measure quality of life participants due to asthma treatment and the scores ranges from 1 to 7 where 1 indicates total impairment and 7 indicates no impairment. A responder to AQLQ will be defined as a participant who has an increase from Baseline in AQLQ score of 0.5 or more.|Spirometry assessment will include pre-bronchodilator FEV1|Spirometry assessment will include pre-bronchodilator FVC|An AE is any untoward medical occurrence in a clinical study participants, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that, at any dose may result in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment.|Laboratory assessment for hematology parameters will include Platelet count, hemoglobin, Red blood cell (RBC) count, hematocrit, Red blood cell distribution width (RDW), RBC indices like mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH) and mean corpuscular hemoglobin concentration (MCHC). White blood cell (WBC) count with differential will include neutrophils, lymphocytes, monocytes, eosinophils and basophils.|Laboratory assessment for clinical chemistry parameters will include blood urea nitrogen (BUN), potassium, calcium, sodium, creatinine, non-fasting glucose, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline phosphate, Gamma-glutamyl transferase (GGT), albumin, phosphorus, carbon dioxide, total protein, creatine phosphokinase (CPK), total and direct bilirubin|Blood pressure will be measured in supine position after 5 minutes rest|Heart rate will be measured in supine position after 5 minutes rest|Single 12-lead ECG will be obtained using an ECG machine that automatically measures heart rate, PR, QRS, QT, and QT interval corrected for heart rate (QTc) and ventricular rate|Holter assessment will be used for quantitative assessment of abnormal rhythm events. Holter monitor will be placed 30-60 minutes prior to dosing.","Day 1 post-end of infusion, Day 15, Pre-dose on Day 29, Pre-dose and post-dose on Day 57, Day 85 and Day 169|Day 1 Pre and post-dose; Day 15; Day 29 Post dose; Day 57 pre and post dose; Day 85, Day 169|Up to Day 172|Baseline and at Weeks 2, 4, 8 and 12|Up to Day 88|Day 1","GSKClinicalSupportHD@gsk.com","US GSK Clinical Trials Call Center","877-379-3718","Brest Cedex, France, 29609|Wythenshawe, Greater Manchester, United Kingdom, M23 9Lt|Leicester, Leicestershire, United Kingdom, Le3 9Qp|Birmingham, United Kingdom, B9 5Ss",null,"France|United Kingdom","Gsk Investigational Site|, Greater Manchester Gsk Investigational Site|, Leicestershire Gsk Investigational Site",{"$nulls":3},"GSK Clinical Trials","2018-06-07","2020-05-25T16:35:49.486","2020-05-26T17:10:42.972","NCT03393806"]
["5ecbf3e511702c1b1b9169fd","NCT03393806","2018-06-12","GlaxoSmithKline","GSK","Recruiting","Repeat Dose Study of GSK3772847 in Participants With Moderate to Severe Asthma With Allergic Fungal Airway Disease (AFAD)","Gsk-3772847",null,"Yes","['Gsk-3772847']","Unknown",null,"Phase 2",2,46,"Anticipated","2018-04-18","2019-05-22",{"$nulls":5},"This study is multicenter, double-blinded parallel group design, where participants with moderate to severe asthma with AFAD will be enrolled. Participants will receive three doses of 10 milligrams/kilogram (mg/kg) of GSK3772847 every 4 Weeks versus placebo along with standard of care. Participants will be randomized in 1:1 ratio to receive either 10 mg/kg GSK3772847 intravenously (IV) or matching placebo IV. Participants will receive study treatment on Week 0 (Day 1), Week 4 and Week 8. The total duration of the study will be 28 Weeks and approximately 46 participants will be randomized.",null,"A Double Blind (Sponsor Open) Placebo-controlled, Stratified, Parallel Group Study to Evaluate the Efficacy and Safety of Repeat Doses of GSK3772847 in Participants With Moderate to Severe Asthma With Allergic Fungal Airway Disease (AFAD)",207972,"Asthma","Asthma","Bronchial Diseases","Respiratory","Experimental|Placebo Comparator","Participants receiving GSK3772847|Participants receiving placebo","Participants will be randomized to receive GSK3772847 as IV infusion. Participants will receive three doses ( Day 1, Day 29 and Day 57) of GSK3772847 every 4 weeks|Participants will be randomized to receive matching placebo as IV infusion","Drug","GSK3772847|Placebo","GSK3772847 will be available as 100 mg/vial, white to yellow, uniform lyophilized cake in a 5 milliliter (mL) clear glass vial with closure sealed by red metal and yellow overseal.|Commercially sourced sterile normal saline will be provided as Placebo",null,"Participants receiving GSK3772847|Participants receiving placebo","\n\n * Participant must be at least 18 years of age inclusive, at the time of signing the informed consent.\n * Documented history of physician diagnosed moderate or severe asthma for >=12 months based on Guidelines and treated with inhaled corticosteroid (ICS) and long-acting beta-2-agonist (LABA) for at least 4 months (>=500 micrograms/day [Âµg/day]) fluticasone propionate or equivalent as defined in the guidelines.\n * Pre-bronchodilator FEV1 35-79% of predicted value for participant inclusive\n * FeNO >= 25 parts per billion (ppb) at Screening\n * ACQ-5 score >= 1.5 at Screening\n * Blood eosinophil >=300 cells/microliter at Screening\n * Evidence of allergic fungal airway disease like Fungal sensitization to any of the fungi Aspergillus fumigatus, Penicillium chrysogenum (notatum) at screening measured by serum-specific Immunoglobulin (Ig) E test. A history of exacerbations with at least 1 severe exacerbation (defined as requiring a minimum of 3 days of high-dose oral corticosteroids for asthma symptoms) in the previous 12 months.\n * Body weight within 50-150 kilogram (kg)\n * Both male and female gender. A female participant is eligible to participate if she is not pregnant not breastfeeding, Not a woman of childbearing potential (WOCBP) or A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 16 weeks after the last dose of study treatment.\n * Capable of giving signed informed consent\n\n","\n\n * Historical diagnosis of cystic fibrosis\n * Concurrent respiratory diseases: Presence of a known pre-existing, clinically important respiratory conditions (example pneumonia, pneumothorax, atelectasis segmental or larger, pulmonary fibrotic disease, bronchopulmonary dysplasia, chronic bronchitis, emphysema, chronic obstructive pulmonary disease, or other respiratory abnormalities) other than asthma or AFAD\n * Has a history of chronic or recurrent non-pulmonary infectious disease or ongoing non-pulmonary infection including, but not limited to, chronic renal infection, chronic chest infection, recurrent urinary tract infection (example, recurrent pyelonephritis, chronic non-remitting cystitis), or open, draining skin wound or an ulcer\n * Serious infection within 8 weeks of enrolment, including, but not limited to hepatitis, pneumonia, sepsis, or pyelonephritis; or has been hospitalized for an infection; or has been treated with IV antibiotics for an infection, within 8 weeks prior to the first administration of study drug.\n * Evidence of poorly controlled chronic medical conditions other than asthma, example, participants with known, pre-existing, clinically significant endocrine, autoimmune, metabolic, neurological, renal, cardiovascular, gastrointestinal, hepatic, and hematological or any other system abnormalities that are uncontrolled with standard treatment.\n * Cardiovascular disease: Clinically significant organic heart disease\n * Participants with a diagnosis of malignancy or in the process of investigation for a malignancy. Participants with carcinoma that have not been in complete remission for at least 5 years. Participants who have had carcinoma in situ of the cervix, squamous cell carcinoma and basal cell carcinoma of the skin would not be excluded based on the 5 year waiting period if the participant has been considered cured by treatment.\n * Eosinophilic diseases: Other conditions that could lead to elevated eosinophil such as hyper-eosinophilic syndromes. Participants with a known, pre-existing parasitic infestation within 6 months prior to Screening (Visit 1)\n * Prohibited medications is not permitted within the defined time intervals prior to Screening (Visit 1) and throughout the study.\n * Presence of hepatitis B surface antigen (HBsAg), positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study treatment.\n * A known immunodeficiency such as human immunodeficiency virus infection.\n * Hypersensitivity: significant allergies to humanized monoclonal antibodies or biologic or to any components of the formulation used in this study\n * Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear Ig A dermatosis, toxic epidermal necrolysis, and exfoliative dermatitis).\n * Clinically significant abnormality on 12-lead ECG assessment at screening (Visit 1). Site investigators will be provided with ECG over-read conducted by a centralized independent cardiologist, to assist in evaluation of participant eligibility.\n * Sinus bradycardia <45 beats per minute (bpm), sinus tachycardia >= 110 bpm, multifocal atrial tachycardia (wandering atrial pacemaker with rate >100bpm), evidence of Mobitz II second degree or third degree atrioventricular (AV) block, pathological Q waves (defined as wide [>0.04 seconds] and deep [>0.4 millivolts (mV) (4 millimeter [mm] with 10mm/mV setting)] or >25% of the height of the corresponding R wave, providing the R wave was >0.5mV [5mm with 10mm/mV setting], appearing in at least two contiguous leads, evidence of ventricular ectopic couplets, bigeminy, trigeminy or multifocal premature ventricular complexes, for participants without complete right bundle branch block: QTc for heart rate by Fridericia's formula QTc(F) >= 450 millisecond (msec) or an ECG that is unsuitable for QT measurements, for participants with complete right bundle branch block: QTc(F) >=480 msec or an ECG that is unsuitable for QT measurements, ST-T wave abnormalities, clinically significant conduction abnormalities and clinically significant arrhythmias.\n * Smoking history: current smokers or former smokers with a smoking history >= 10 pack years\n * History of alcohol or illegal substance abuse within 2 years prior to Screening (Visit1).\n * Participants at risk of non-compliance, or unable to comply with the study procedures. Participants who are unable to follow study instructions such as visit schedule and paper diary completion. Participants who have known evidence of lack of adherence to controller medication and/or ability to follow physician's recommendations. Any infirmity, disability, or geographic location that would limit compliance for scheduled visits.",{"$nulls":4},"Actual","2018-01-09","Actual","Anticipated","2019-08-14","Anticipated","2018-06-01","2018-01-03","2018-01-03","2018-06-11","No","Asthma Control Questionnaire\nAllergic fungal airway disease\nAsthma Quality of Life Questionnaire\nHolter monitoring\nAsthma","Interventional","Treatment","Parallel Assignment","Double (Participant, Investigator)","Randomized","18 Years",null,"All",null,"No","Yes\nIPD for this study will be made available via the Clinical Study Data Request site.",{"$nulls":3},"No","No",{"$nulls":19},"Change from Baseline in blood eosinophils|Change from Baseline in fractional exhaled nitric oxide (FeNO)","Blood samples will be collected at indicated time points for the assessment of eosinophil|FeNO will be measured using a handheld electronic device","Baseline and up to Day 88","Serum concentrations of GSK3772847|Serum levels of free soluble suppressor of tumorigenicity 2 (ST2)|Serum levels of total soluble ST2|Number of participants with positive result of serum anti-GSK3772847 antibodies post dosing|Titers of serum anti-GSK3772847 antibodies post dosing|Change from Baseline in Asthma Control Questionnaire-5 (ACQ-5) absolute score at Weeks 2, 4, 8 and 12|Change from Baseline in Asthma Quality of Life Questionnaire (AQLQ) total and domain scores at Weeks 2, 4, 8 and 12|Number of responders to ACQ-5|Number of responders to AQLQ|Change from Baseline in forced expiratory volume in 1 second (FEV1)|Change from Baseline in forced vital capacity (FVC)|Number of participants with treatment emergent adverse events (AE) and serious AEs (SAE)|Number of participants with abnormal hematology parameters|Number of participants with abnormal clinical chemistry parameters|Number of participants with abnormal systolic blood pressure (SBP) and diastolic blood pressure (DBP)|Number of participants with abnormal heart rate|Number of participants with abnormal findings in Electrocardiogram (ECG)|Number of participants with abnormal 24-hour Holter findings","Blood samples will be collected at indicated time points for assessment of serum concentrations|Blood samples will be collected at indicated time points to measure free soluble ST2|Blood samples will be collected at indicated time points to measure total soluble ST2|Blood samples will be collected at indicated time points and anti-GSK3772847 antibodies will be assessed using a tiered approach.|ACQ-5 is a 5-item questionnaire that is a measure of the participant's asthma control. The five questions include about the frequency and/or severity of symptoms like nocturnal awakening, activity limitation, shortness of breath and wheeze. The score scales from zero (totally controlled) and 6 (severely uncontrolled)|AQLQ is 32 items four domains questionnaire used for evaluation of impact of asthma treatments on the quality of life of participants. The scores are evaluated from 1 (total impairment) and 7 (no impairment)|ACQ-5 is a 5 question tool used to measure attributes of asthma control and the score ranges from 0 to 6 where 0 is no impairment/limitation and 6 is total impairment/limitation. A responder to ACQ-5 will be defined as a participant who has a decrease from Baseline in ACQ-5 score of 0.5 or more.|AQLQ is a 32 items four domain questionnaire used to measure quality of life participants due to asthma treatment and the scores ranges from 1 to 7 where 1 indicates total impairment and 7 indicates no impairment. A responder to AQLQ will be defined as a participant who has an increase from Baseline in AQLQ score of 0.5 or more.|Spirometry assessment will include pre-bronchodilator FEV1|Spirometry assessment will include pre-bronchodilator FVC|An AE is any untoward medical occurrence in a clinical study participants, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that, at any dose may result in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment.|Laboratory assessment for hematology parameters will include Platelet count, hemoglobin, Red blood cell (RBC) count, hematocrit, Red blood cell distribution width (RDW), RBC indices like mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH) and mean corpuscular hemoglobin concentration (MCHC). White blood cell (WBC) count with differential will include neutrophils, lymphocytes, monocytes, eosinophils and basophils.|Laboratory assessment for clinical chemistry parameters will include blood urea nitrogen (BUN), potassium, calcium, sodium, creatinine, non-fasting glucose, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline phosphate, Gamma-glutamyl transferase (GGT), albumin, phosphorus, carbon dioxide, total protein, creatine phosphokinase (CPK), total and direct bilirubin|Blood pressure will be measured in supine position after 5 minutes rest|Heart rate will be measured in supine position after 5 minutes rest|Single 12-lead ECG will be obtained using an ECG machine that automatically measures heart rate, PR, QRS, QT, and QT interval corrected for heart rate (QTc) and ventricular rate|Holter assessment will be used for quantitative assessment of abnormal rhythm events. Holter monitor will be placed 30-60 minutes prior to dosing.","Day 1 post-end of infusion, Day 15, Pre-dose on Day 29, Pre-dose and post-dose on Day 57, Day 85 and Day 169|Day 1 Pre and post-dose; Day 15; Day 29 Post dose; Day 57 pre and post dose; Day 85, Day 169|Up to Day 172|Baseline and at Weeks 2, 4, 8 and 12|Up to Day 88|Day 1","GSKClinicalSupportHD@gsk.com","US GSK Clinical Trials Call Center","877-379-3718","Brest Cedex, France, 29609|Wythenshawe, Greater Manchester, United Kingdom, M23 9Lt|Leicester, Leicestershire, United Kingdom, Le3 9Qp|Birmingham, United Kingdom, B9 5Ss",null,"France|United Kingdom","Gsk Investigational Site|, Greater Manchester Gsk Investigational Site|, Leicestershire Gsk Investigational Site",{"$nulls":3},"GSK Clinical Trials","2018-06-11","2020-05-25T16:35:49.296","2020-05-26T17:10:42.972","NCT03393806"]
["5ecbf3e5feab101b1553081b","NCT03393806","2018-07-27","GlaxoSmithKline","GSK","Recruiting","Repeat Dose Study of GSK3772847 in Participants With Moderate to Severe Asthma With Allergic Fungal Airway Disease (AFAD)","Gsk-3772847",null,"Yes","['Gsk-3772847']","Unknown",null,"Phase 2",2,46,"Anticipated","2018-04-18","2019-05-22",{"$nulls":5},"This study is multicenter, double-blinded parallel group design, where participants with moderate to severe asthma with AFAD will be enrolled. Participants will receive three doses of 10 milligrams/kilogram (mg/kg) of GSK3772847 every 4 Weeks versus placebo along with standard of care. Participants will be randomized in 1:1 ratio to receive either 10 mg/kg GSK3772847 intravenously (IV) or matching placebo IV. Participants will receive study treatment on Week 0 (Day 1), Week 4 and Week 8. The total duration of the study will be 28 Weeks and approximately 46 participants will be randomized.",null,"A Double Blind (Sponsor Open) Placebo-controlled, Stratified, Parallel Group Study to Evaluate the Efficacy and Safety of Repeat Doses of GSK3772847 in Participants With Moderate to Severe Asthma With Allergic Fungal Airway Disease (AFAD)",207972,"Asthma","Asthma","Bronchial Diseases","Respiratory","Experimental|Placebo Comparator","Participants receiving GSK3772847|Participants receiving placebo","Participants will be randomized to receive GSK3772847 as IV infusion. Participants will receive three doses ( Day 1, Day 29 and Day 57) of GSK3772847 every 4 weeks|Participants will be randomized to receive matching placebo as IV infusion","Drug","GSK3772847|Placebo","GSK3772847 will be available as 100 mg/vial, white to yellow, uniform lyophilized cake in a 5 milliliter (mL) clear glass vial with closure sealed by red metal and yellow overseal.|Commercially sourced sterile normal saline will be provided as Placebo",null,"Participants receiving GSK3772847|Participants receiving placebo","\n\n * Participant must be at least 18 years of age inclusive, at the time of signing the informed consent.\n * Documented history of physician diagnosed moderate or severe asthma for >=12 months based on Guidelines and treated with inhaled corticosteroid (ICS) and long-acting beta-2-agonist (LABA) for at least 4 months (>=500 micrograms/day [Âµg/day]) fluticasone propionate or equivalent as defined in the guidelines.\n * Pre-bronchodilator FEV1 35-79% of predicted value for participant inclusive\n * FeNO >= 25 parts per billion (ppb) at Screening\n * ACQ-5 score >= 1.5 at Screening\n * Blood eosinophil >=300 cells/microliter at Screening\n * Evidence of allergic fungal airway disease like Fungal sensitization to any of the fungi Aspergillus fumigatus, Penicillium chrysogenum (notatum) at screening measured by serum-specific Immunoglobulin (Ig) E test. A history of exacerbations with at least 1 severe exacerbation (defined as requiring a minimum of 3 days of high-dose oral corticosteroids for asthma symptoms) in the previous 12 months.\n * Body weight within 50-150 kilogram (kg)\n * Both male and female gender. A female participant is eligible to participate if she is not pregnant not breastfeeding, Not a woman of childbearing potential (WOCBP) or A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 16 weeks after the last dose of study treatment.\n * Capable of giving signed informed consent\n\n","\n\n * Historical diagnosis of cystic fibrosis\n * Concurrent respiratory diseases: Presence of a known pre-existing, clinically important respiratory conditions (example pneumonia, pneumothorax, atelectasis segmental or larger, pulmonary fibrotic disease, bronchopulmonary dysplasia, chronic bronchitis, emphysema, chronic obstructive pulmonary disease, or other respiratory abnormalities) other than asthma or AFAD\n * Has a history of chronic or recurrent non-pulmonary infectious disease or ongoing non-pulmonary infection including, but not limited to, chronic renal infection, chronic chest infection, recurrent urinary tract infection (example, recurrent pyelonephritis, chronic non-remitting cystitis), or open, draining skin wound or an ulcer\n * Serious infection within 8 weeks of enrolment, including, but not limited to hepatitis, pneumonia, sepsis, or pyelonephritis; or has been hospitalized for an infection; or has been treated with IV antibiotics for an infection, within 8 weeks prior to the first administration of study drug.\n * Evidence of poorly controlled chronic medical conditions other than asthma, example, participants with known, pre-existing, clinically significant endocrine, autoimmune, metabolic, neurological, renal, cardiovascular, gastrointestinal, hepatic, and hematological or any other system abnormalities that are uncontrolled with standard treatment.\n * Cardiovascular disease: Clinically significant organic heart disease\n * Participants with a diagnosis of malignancy or in the process of investigation for a malignancy. Participants with carcinoma that have not been in complete remission for at least 5 years. Participants who have had carcinoma in situ of the cervix, squamous cell carcinoma and basal cell carcinoma of the skin would not be excluded based on the 5 year waiting period if the participant has been considered cured by treatment.\n * Eosinophilic diseases: Other conditions that could lead to elevated eosinophil such as hyper-eosinophilic syndromes. Participants with a known, pre-existing parasitic infestation within 6 months prior to Screening (Visit 1)\n * Prohibited medications is not permitted within the defined time intervals prior to Screening (Visit 1) and throughout the study.\n * Presence of hepatitis B surface antigen (HBsAg), positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study treatment.\n * A known immunodeficiency such as human immunodeficiency virus infection.\n * Hypersensitivity: significant allergies to humanized monoclonal antibodies or biologic or to any components of the formulation used in this study\n * Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear Ig A dermatosis, toxic epidermal necrolysis, and exfoliative dermatitis).\n * Clinically significant abnormality on 12-lead ECG assessment at screening (Visit 1). Site investigators will be provided with ECG over-read conducted by a centralized independent cardiologist, to assist in evaluation of participant eligibility.\n * Sinus bradycardia <45 beats per minute (bpm), sinus tachycardia >= 110 bpm, multifocal atrial tachycardia (wandering atrial pacemaker with rate >100bpm), evidence of Mobitz II second degree or third degree atrioventricular (AV) block, pathological Q waves (defined as wide [>0.04 seconds] and deep [>0.4 millivolts (mV) (4 millimeter [mm] with 10mm/mV setting)] or >25% of the height of the corresponding R wave, providing the R wave was >0.5mV [5mm with 10mm/mV setting], appearing in at least two contiguous leads, evidence of ventricular ectopic couplets, bigeminy, trigeminy or multifocal premature ventricular complexes, for participants without complete right bundle branch block: QTc for heart rate by Fridericia's formula QTc(F) >= 450 millisecond (msec) or an ECG that is unsuitable for QT measurements, for participants with complete right bundle branch block: QTc(F) >=480 msec or an ECG that is unsuitable for QT measurements, ST-T wave abnormalities, clinically significant conduction abnormalities and clinically significant arrhythmias.\n * Smoking history: current smokers or former smokers with a smoking history >= 10 pack years\n * History of alcohol or illegal substance abuse within 2 years prior to Screening (Visit1).\n * Participants at risk of non-compliance, or unable to comply with the study procedures. Participants who are unable to follow study instructions such as visit schedule and paper diary completion. Participants who have known evidence of lack of adherence to controller medication and/or ability to follow physician's recommendations. Any infirmity, disability, or geographic location that would limit compliance for scheduled visits.",{"$nulls":4},"Actual","2018-01-09","Actual","Anticipated","2019-08-14","Anticipated","2018-07-01","2018-01-03","2018-01-03","2018-07-26","No","Asthma Control Questionnaire\nAllergic fungal airway disease\nAsthma Quality of Life Questionnaire\nHolter monitoring\nAsthma","Interventional","Treatment","Parallel Assignment","Double (Participant, Investigator)","Randomized","18 Years",null,"All",null,"No","Yes\nIPD for this study will be made available via the Clinical Study Data Request site.",{"$nulls":3},"No","No",{"$nulls":19},"Change from Baseline in blood eosinophils|Change from Baseline in fractional exhaled nitric oxide (FeNO)","Blood samples will be collected at indicated time points for the assessment of eosinophil|FeNO will be measured using a handheld electronic device","Baseline and up to Day 88","Serum concentrations of GSK3772847|Serum levels of free soluble suppressor of tumorigenicity 2 (ST2)|Serum levels of total soluble ST2|Number of participants with positive result of serum anti-GSK3772847 antibodies post dosing|Titers of serum anti-GSK3772847 antibodies post dosing|Change from Baseline in Asthma Control Questionnaire-5 (ACQ-5) absolute score at Weeks 2, 4, 8 and 12|Change from Baseline in Asthma Quality of Life Questionnaire (AQLQ) total and domain scores at Weeks 2, 4, 8 and 12|Number of responders to ACQ-5|Number of responders to AQLQ|Change from Baseline in forced expiratory volume in 1 second (FEV1)|Change from Baseline in forced vital capacity (FVC)|Number of participants with treatment emergent adverse events (AE) and serious AEs (SAE)|Number of participants with abnormal hematology parameters|Number of participants with abnormal clinical chemistry parameters|Number of participants with abnormal systolic blood pressure (SBP) and diastolic blood pressure (DBP)|Number of participants with abnormal heart rate|Number of participants with abnormal findings in Electrocardiogram (ECG)|Number of participants with abnormal 24-hour Holter findings","Blood samples will be collected at indicated time points for assessment of serum concentrations|Blood samples will be collected at indicated time points to measure free soluble ST2|Blood samples will be collected at indicated time points to measure total soluble ST2|Blood samples will be collected at indicated time points and anti-GSK3772847 antibodies will be assessed using a tiered approach.|ACQ-5 is a 5-item questionnaire that is a measure of the participant's asthma control. The five questions include about the frequency and/or severity of symptoms like nocturnal awakening, activity limitation, shortness of breath and wheeze. The score scales from zero (totally controlled) and 6 (severely uncontrolled)|AQLQ is 32 items four domains questionnaire used for evaluation of impact of asthma treatments on the quality of life of participants. The scores are evaluated from 1 (total impairment) and 7 (no impairment)|ACQ-5 is a 5 question tool used to measure attributes of asthma control and the score ranges from 0 to 6 where 0 is no impairment/limitation and 6 is total impairment/limitation. A responder to ACQ-5 will be defined as a participant who has a decrease from Baseline in ACQ-5 score of 0.5 or more.|AQLQ is a 32 items four domain questionnaire used to measure quality of life participants due to asthma treatment and the scores ranges from 1 to 7 where 1 indicates total impairment and 7 indicates no impairment. A responder to AQLQ will be defined as a participant who has an increase from Baseline in AQLQ score of 0.5 or more.|Spirometry assessment will include pre-bronchodilator FEV1|Spirometry assessment will include pre-bronchodilator FVC|An AE is any untoward medical occurrence in a clinical study participants, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that, at any dose may result in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment.|Laboratory assessment for hematology parameters will include Platelet count, hemoglobin, Red blood cell (RBC) count, hematocrit, Red blood cell distribution width (RDW), RBC indices like mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH) and mean corpuscular hemoglobin concentration (MCHC). White blood cell (WBC) count with differential will include neutrophils, lymphocytes, monocytes, eosinophils and basophils.|Laboratory assessment for clinical chemistry parameters will include blood urea nitrogen (BUN), potassium, calcium, sodium, creatinine, non-fasting glucose, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline phosphate, Gamma-glutamyl transferase (GGT), albumin, phosphorus, carbon dioxide, total protein, creatine phosphokinase (CPK), total and direct bilirubin|Blood pressure will be measured in supine position after 5 minutes rest|Heart rate will be measured in supine position after 5 minutes rest|Single 12-lead ECG will be obtained using an ECG machine that automatically measures heart rate, PR, QRS, QT, and QT interval corrected for heart rate (QTc) and ventricular rate|Holter assessment will be used for quantitative assessment of abnormal rhythm events. Holter monitor will be placed 30-60 minutes prior to dosing.","Day 1 post-end of infusion, Day 15, Pre-dose on Day 29, Pre-dose and post-dose on Day 57, Day 85 and Day 169|Day 1 Pre and post-dose; Day 15; Day 29 Post dose; Day 57 pre and post dose; Day 85, Day 169|Up to Day 172|Baseline and at Weeks 2, 4, 8 and 12|Up to Day 88|Day 1","GSKClinicalSupportHD@gsk.com","US GSK Clinical Trials Call Center","877-379-3718","Brest Cedex, France, 29609|Wythenshawe, Greater Manchester, United Kingdom, M23 9Lt|Leicester, Leicestershire, United Kingdom, Le3 9Qp|Birmingham, United Kingdom, B9 5Ss",null,"France|United Kingdom","Gsk Investigational Site|, Greater Manchester Gsk Investigational Site|, Leicestershire Gsk Investigational Site",{"$nulls":3},"GSK Clinical Trials","2018-07-26","2020-05-25T16:35:49.317","2020-05-26T17:10:42.972","NCT03393806"]
["5ecbf3e5e2561b1b11905ce7","NCT03393806","2018-08-03","GlaxoSmithKline","GSK","Recruiting","Repeat Dose Study of GSK3772847 in Participants With Moderate to Severe Asthma With Allergic Fungal Airway Disease (AFAD)","Gsk-3772847",null,"Yes","['Gsk-3772847']","Unknown",null,"Phase 2",2,46,"Anticipated","2018-04-18","2019-05-22",{"$nulls":5},"This study is multicenter, double-blinded parallel group design, where participants with moderate to severe asthma with AFAD will be enrolled. Participants will receive three doses of 10 milligrams/kilogram (mg/kg) of GSK3772847 every 4 Weeks versus placebo along with standard of care. Participants will be randomized in 1:1 ratio to receive either 10 mg/kg GSK3772847 intravenously (IV) or matching placebo IV. Participants will receive study treatment on Week 0 (Day 1), Week 4 and Week 8. The total duration of the study will be 28 Weeks and approximately 46 participants will be randomized.",null,"A Double Blind (Sponsor Open) Placebo-controlled, Stratified, Parallel Group Study to Evaluate the Efficacy and Safety of Repeat Doses of GSK3772847 in Participants With Moderate to Severe Asthma With Allergic Fungal Airway Disease (AFAD)",207972,"Asthma","Asthma","Bronchial Diseases","Respiratory","Experimental|Placebo Comparator","Participants receiving GSK3772847|Participants receiving placebo","Participants will be randomized to receive GSK3772847 as IV infusion. Participants will receive three doses ( Day 1, Day 29 and Day 57) of GSK3772847 every 4 weeks|Participants will be randomized to receive matching placebo as IV infusion","Drug","GSK3772847|Placebo","GSK3772847 will be available as 100 mg/vial, white to yellow, uniform lyophilized cake in a 5 milliliter (mL) clear glass vial with closure sealed by red metal and yellow overseal.|Commercially sourced sterile normal saline will be provided as Placebo",null,"Participants receiving GSK3772847|Participants receiving placebo","\n\n * Participant must be at least 18 years of age inclusive, at the time of signing the informed consent.\n * Documented history of physician diagnosed moderate or severe asthma for >=12 months based on Guidelines and treated with inhaled corticosteroid (ICS) and long-acting beta-2-agonist (LABA) for at least 4 months (>=500 micrograms/day [Âµg/day]) fluticasone propionate or equivalent as defined in the guidelines.\n * Pre-bronchodilator FEV1 35-79% of predicted value for participant inclusive\n * FeNO >= 25 parts per billion (ppb) at Screening\n * ACQ-5 score >= 1.5 at Screening\n * Blood eosinophil >=300 cells/microliter at Screening\n * Evidence of allergic fungal airway disease like Fungal sensitization to any of the fungi Aspergillus fumigatus, Penicillium chrysogenum (notatum) at screening measured by serum-specific Immunoglobulin (Ig) E test. A history of exacerbations with at least 1 severe exacerbation (defined as requiring a minimum of 3 days of high-dose oral corticosteroids for asthma symptoms) in the previous 12 months.\n * Body weight within 50-150 kilogram (kg)\n * Both male and female gender. A female participant is eligible to participate if she is not pregnant not breastfeeding, Not a woman of childbearing potential (WOCBP) or A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 16 weeks after the last dose of study treatment.\n * Capable of giving signed informed consent\n\n","\n\n * Historical diagnosis of cystic fibrosis\n * Concurrent respiratory diseases: Presence of a known pre-existing, clinically important respiratory conditions (example pneumonia, pneumothorax, atelectasis segmental or larger, pulmonary fibrotic disease, bronchopulmonary dysplasia, chronic bronchitis, emphysema, chronic obstructive pulmonary disease, or other respiratory abnormalities) other than asthma or AFAD\n * Has a history of chronic or recurrent non-pulmonary infectious disease or ongoing non-pulmonary infection including, but not limited to, chronic renal infection, chronic chest infection, recurrent urinary tract infection (example, recurrent pyelonephritis, chronic non-remitting cystitis), or open, draining skin wound or an ulcer\n * Serious infection within 8 weeks of enrolment, including, but not limited to hepatitis, pneumonia, sepsis, or pyelonephritis; or has been hospitalized for an infection; or has been treated with IV antibiotics for an infection, within 8 weeks prior to the first administration of study drug.\n * Evidence of poorly controlled chronic medical conditions other than asthma, example, participants with known, pre-existing, clinically significant endocrine, autoimmune, metabolic, neurological, renal, cardiovascular, gastrointestinal, hepatic, and hematological or any other system abnormalities that are uncontrolled with standard treatment.\n * Cardiovascular disease: Clinically significant organic heart disease\n * Participants with a diagnosis of malignancy or in the process of investigation for a malignancy. Participants with carcinoma that have not been in complete remission for at least 5 years. Participants who have had carcinoma in situ of the cervix, squamous cell carcinoma and basal cell carcinoma of the skin would not be excluded based on the 5 year waiting period if the participant has been considered cured by treatment.\n * Eosinophilic diseases: Other conditions that could lead to elevated eosinophil such as hyper-eosinophilic syndromes. Participants with a known, pre-existing parasitic infestation within 6 months prior to Screening (Visit 1)\n * Prohibited medications is not permitted within the defined time intervals prior to Screening (Visit 1) and throughout the study.\n * Presence of hepatitis B surface antigen (HBsAg), positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study treatment.\n * A known immunodeficiency such as human immunodeficiency virus infection.\n * Hypersensitivity: significant allergies to humanized monoclonal antibodies or biologic or to any components of the formulation used in this study\n * Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear Ig A dermatosis, toxic epidermal necrolysis, and exfoliative dermatitis).\n * Clinically significant abnormality on 12-lead ECG assessment at screening (Visit 1). Site investigators will be provided with ECG over-read conducted by a centralized independent cardiologist, to assist in evaluation of participant eligibility.\n * Sinus bradycardia <45 beats per minute (bpm), sinus tachycardia >= 110 bpm, multifocal atrial tachycardia (wandering atrial pacemaker with rate >100bpm), evidence of Mobitz II second degree or third degree atrioventricular (AV) block, pathological Q waves (defined as wide [>0.04 seconds] and deep [>0.4 millivolts (mV) (4 millimeter [mm] with 10mm/mV setting)] or >25% of the height of the corresponding R wave, providing the R wave was >0.5mV [5mm with 10mm/mV setting], appearing in at least two contiguous leads, evidence of ventricular ectopic couplets, bigeminy, trigeminy or multifocal premature ventricular complexes, for participants without complete right bundle branch block: QTc for heart rate by Fridericia's formula QTc(F) >= 450 millisecond (msec) or an ECG that is unsuitable for QT measurements, for participants with complete right bundle branch block: QTc(F) >=480 msec or an ECG that is unsuitable for QT measurements, ST-T wave abnormalities, clinically significant conduction abnormalities and clinically significant arrhythmias.\n * Smoking history: current smokers or former smokers with a smoking history >= 10 pack years\n * History of alcohol or illegal substance abuse within 2 years prior to Screening (Visit1).\n * Participants at risk of non-compliance, or unable to comply with the study procedures. Participants who are unable to follow study instructions such as visit schedule and paper diary completion. Participants who have known evidence of lack of adherence to controller medication and/or ability to follow physician's recommendations. Any infirmity, disability, or geographic location that would limit compliance for scheduled visits.",{"$nulls":4},"Actual","2018-01-09","Actual","Anticipated","2019-08-14","Anticipated","2018-08-01","2018-01-03","2018-01-03","2018-08-02","No","Asthma Control Questionnaire\nAllergic fungal airway disease\nAsthma Quality of Life Questionnaire\nHolter monitoring\nAsthma","Interventional","Treatment","Parallel Assignment","Double (Participant, Investigator)","Randomized","18 Years",null,"All",null,"No","Yes\nIPD for this study will be made available via the Clinical Study Data Request site.",{"$nulls":3},"No","No",{"$nulls":19},"Change from Baseline in blood eosinophils|Change from Baseline in fractional exhaled nitric oxide (FeNO)","Blood samples will be collected at indicated time points for the assessment of eosinophil|FeNO will be measured using a handheld electronic device","Baseline and up to Day 88","Serum concentrations of GSK3772847|Serum levels of free soluble suppressor of tumorigenicity 2 (ST2)|Serum levels of total soluble ST2|Number of participants with positive result of serum anti-GSK3772847 antibodies post dosing|Titers of serum anti-GSK3772847 antibodies post dosing|Change from Baseline in Asthma Control Questionnaire-5 (ACQ-5) absolute score at Weeks 2, 4, 8 and 12|Change from Baseline in Asthma Quality of Life Questionnaire (AQLQ) total and domain scores at Weeks 2, 4, 8 and 12|Number of responders to ACQ-5|Number of responders to AQLQ|Change from Baseline in forced expiratory volume in 1 second (FEV1)|Change from Baseline in forced vital capacity (FVC)|Number of participants with treatment emergent adverse events (AE) and serious AEs (SAE)|Number of participants with abnormal hematology parameters|Number of participants with abnormal clinical chemistry parameters|Number of participants with abnormal systolic blood pressure (SBP) and diastolic blood pressure (DBP)|Number of participants with abnormal heart rate|Number of participants with abnormal findings in Electrocardiogram (ECG)|Number of participants with abnormal 24-hour Holter findings","Blood samples will be collected at indicated time points for assessment of serum concentrations|Blood samples will be collected at indicated time points to measure free soluble ST2|Blood samples will be collected at indicated time points to measure total soluble ST2|Blood samples will be collected at indicated time points and anti-GSK3772847 antibodies will be assessed using a tiered approach.|ACQ-5 is a 5-item questionnaire that is a measure of the participant's asthma control. The five questions include about the frequency and/or severity of symptoms like nocturnal awakening, activity limitation, shortness of breath and wheeze. The score scales from zero (totally controlled) and 6 (severely uncontrolled)|AQLQ is 32 items four domains questionnaire used for evaluation of impact of asthma treatments on the quality of life of participants. The scores are evaluated from 1 (total impairment) and 7 (no impairment)|ACQ-5 is a 5 question tool used to measure attributes of asthma control and the score ranges from 0 to 6 where 0 is no impairment/limitation and 6 is total impairment/limitation. A responder to ACQ-5 will be defined as a participant who has a decrease from Baseline in ACQ-5 score of 0.5 or more.|AQLQ is a 32 items four domain questionnaire used to measure quality of life participants due to asthma treatment and the scores ranges from 1 to 7 where 1 indicates total impairment and 7 indicates no impairment. A responder to AQLQ will be defined as a participant who has an increase from Baseline in AQLQ score of 0.5 or more.|Spirometry assessment will include pre-bronchodilator FEV1|Spirometry assessment will include pre-bronchodilator FVC|An AE is any untoward medical occurrence in a clinical study participants, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that, at any dose may result in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment.|Laboratory assessment for hematology parameters will include Platelet count, hemoglobin, Red blood cell (RBC) count, hematocrit, Red blood cell distribution width (RDW), RBC indices like mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH) and mean corpuscular hemoglobin concentration (MCHC). White blood cell (WBC) count with differential will include neutrophils, lymphocytes, monocytes, eosinophils and basophils.|Laboratory assessment for clinical chemistry parameters will include blood urea nitrogen (BUN), potassium, calcium, sodium, creatinine, non-fasting glucose, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline phosphate, Gamma-glutamyl transferase (GGT), albumin, phosphorus, carbon dioxide, total protein, creatine phosphokinase (CPK), total and direct bilirubin|Blood pressure will be measured in supine position after 5 minutes rest|Heart rate will be measured in supine position after 5 minutes rest|Single 12-lead ECG will be obtained using an ECG machine that automatically measures heart rate, PR, QRS, QT, and QT interval corrected for heart rate (QTc) and ventricular rate|Holter assessment will be used for quantitative assessment of abnormal rhythm events. Holter monitor will be placed 30-60 minutes prior to dosing.","Day 1 post-end of infusion, Day 15, Pre-dose on Day 29, Pre-dose and post-dose on Day 57, Day 85 and Day 169|Day 1 Pre and post-dose; Day 15; Day 29 Post dose; Day 57 pre and post dose; Day 85, Day 169|Up to Day 172|Baseline and at Weeks 2, 4, 8 and 12|Up to Day 88|Day 1","GSKClinicalSupportHD@gsk.com","US GSK Clinical Trials Call Center","877-379-3718","Brest Cedex, France, 29609|Wythenshawe, Greater Manchester, United Kingdom, M23 9Lt|Leicester, Leicestershire, United Kingdom, Le3 9Qp|Birmingham, United Kingdom, B9 5Ss",null,"France|United Kingdom","Gsk Investigational Site|, Greater Manchester Gsk Investigational Site|, Leicestershire Gsk Investigational Site",{"$nulls":3},"GSK Clinical Trials","2018-08-02","2020-05-25T16:35:49.377","2020-05-26T17:10:42.972","NCT03393806"]
["5ecbf3e5307e3d1b1f8d9c7c","NCT03393806","2018-08-15","GlaxoSmithKline","GSK","Recruiting","Repeat Dose Study of GSK3772847 in Participants With Moderate to Severe Asthma With Allergic Fungal Airway Disease (AFAD)","Gsk-3772847",null,"Yes","['Gsk-3772847']","Unknown",null,"Phase 2",2,46,"Anticipated","2018-04-18","2019-05-22",{"$nulls":5},"This study is multicenter, double-blinded parallel group design, where participants with moderate to severe asthma with AFAD will be enrolled. Participants will receive three doses of 10 milligrams/kilogram (mg/kg) of GSK3772847 every 4 Weeks versus placebo along with standard of care. Participants will be randomized in 1:1 ratio to receive either 10 mg/kg GSK3772847 intravenously (IV) or matching placebo IV. Participants will receive study treatment on Week 0 (Day 1), Week 4 and Week 8. The total duration of the study will be 28 Weeks and approximately 46 participants will be randomized.",null,"A Double Blind (Sponsor Open) Placebo-controlled, Stratified, Parallel Group Study to Evaluate the Efficacy and Safety of Repeat Doses of GSK3772847 in Participants With Moderate to Severe Asthma With Allergic Fungal Airway Disease (AFAD)",207972,"Asthma","Asthma","Bronchial Diseases","Respiratory","Experimental|Placebo Comparator","Participants receiving GSK3772847|Participants receiving placebo","Participants will be randomized to receive GSK3772847 as IV infusion. Participants will receive three doses ( Day 1, Day 29 and Day 57) of GSK3772847 every 4 weeks|Participants will be randomized to receive matching placebo as IV infusion","Drug","GSK3772847|Placebo","GSK3772847 will be available as 100 mg/vial, white to yellow, uniform lyophilized cake in a 5 milliliter (mL) clear glass vial with closure sealed by red metal and yellow overseal.|Commercially sourced sterile normal saline will be provided as Placebo",null,"Participants receiving GSK3772847|Participants receiving placebo","\n\n * Participant must be at least 18 years of age inclusive, at the time of signing the informed consent.\n * Documented history of physician diagnosed moderate or severe asthma for >=12 months based on Guidelines and treated with inhaled corticosteroid (ICS) and long-acting beta-2-agonist (LABA) for at least 4 months (>=500 micrograms/day [Âµg/day]) fluticasone propionate or equivalent as defined in the guidelines.\n * Pre-bronchodilator FEV1 35-79% of predicted value for participant inclusive\n * FeNO >= 25 parts per billion (ppb) at Screening\n * ACQ-5 score >= 1.5 at Screening\n * Blood eosinophil >=300 cells/microliter at Screening\n * Evidence of allergic fungal airway disease like Fungal sensitization to any of the fungi Aspergillus fumigatus, Penicillium chrysogenum (notatum) at screening measured by serum-specific Immunoglobulin (Ig) E test. A history of exacerbations with at least 1 severe exacerbation (defined as requiring a minimum of 3 days of high-dose oral corticosteroids for asthma symptoms) in the previous 12 months.\n * Body weight within 50-150 kilogram (kg)\n * Both male and female gender. A female participant is eligible to participate if she is not pregnant not breastfeeding, Not a woman of childbearing potential (WOCBP) or A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 16 weeks after the last dose of study treatment.\n * Capable of giving signed informed consent\n\n","\n\n * Historical diagnosis of cystic fibrosis\n * Concurrent respiratory diseases: Presence of a known pre-existing, clinically important respiratory conditions (example pneumonia, pneumothorax, atelectasis segmental or larger, pulmonary fibrotic disease, bronchopulmonary dysplasia, chronic bronchitis, emphysema, chronic obstructive pulmonary disease, or other respiratory abnormalities) other than asthma or AFAD\n * Has a history of chronic or recurrent non-pulmonary infectious disease or ongoing non-pulmonary infection including, but not limited to, chronic renal infection, chronic chest infection, recurrent urinary tract infection (example, recurrent pyelonephritis, chronic non-remitting cystitis), or open, draining skin wound or an ulcer\n * Serious infection within 8 weeks of enrolment, including, but not limited to hepatitis, pneumonia, sepsis, or pyelonephritis; or has been hospitalized for an infection; or has been treated with IV antibiotics for an infection, within 8 weeks prior to the first administration of study drug.\n * Evidence of poorly controlled chronic medical conditions other than asthma, example, participants with known, pre-existing, clinically significant endocrine, autoimmune, metabolic, neurological, renal, cardiovascular, gastrointestinal, hepatic, and hematological or any other system abnormalities that are uncontrolled with standard treatment.\n * Cardiovascular disease: Clinically significant organic heart disease\n * Participants with a diagnosis of malignancy or in the process of investigation for a malignancy. Participants with carcinoma that have not been in complete remission for at least 5 years. Participants who have had carcinoma in situ of the cervix, squamous cell carcinoma and basal cell carcinoma of the skin would not be excluded based on the 5 year waiting period if the participant has been considered cured by treatment.\n * Eosinophilic diseases: Other conditions that could lead to elevated eosinophil such as hyper-eosinophilic syndromes. Participants with a known, pre-existing parasitic infestation within 6 months prior to Screening (Visit 1)\n * Prohibited medications is not permitted within the defined time intervals prior to Screening (Visit 1) and throughout the study.\n * Presence of hepatitis B surface antigen (HBsAg), positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study treatment.\n * A known immunodeficiency such as human immunodeficiency virus infection.\n * Hypersensitivity: significant allergies to humanized monoclonal antibodies or biologic or to any components of the formulation used in this study\n * Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear Ig A dermatosis, toxic epidermal necrolysis, and exfoliative dermatitis).\n * Clinically significant abnormality on 12-lead ECG assessment at screening (Visit 1). Site investigators will be provided with ECG over-read conducted by a centralized independent cardiologist, to assist in evaluation of participant eligibility.\n * Sinus bradycardia <45 beats per minute (bpm), sinus tachycardia >= 110 bpm, multifocal atrial tachycardia (wandering atrial pacemaker with rate >100bpm), evidence of Mobitz II second degree or third degree atrioventricular (AV) block, pathological Q waves (defined as wide [>0.04 seconds] and deep [>0.4 millivolts (mV) (4 millimeter [mm] with 10mm/mV setting)] or >25% of the height of the corresponding R wave, providing the R wave was >0.5mV [5mm with 10mm/mV setting], appearing in at least two contiguous leads, evidence of ventricular ectopic couplets, bigeminy, trigeminy or multifocal premature ventricular complexes, for participants without complete right bundle branch block: QTc for heart rate by Fridericia's formula QTc(F) >= 450 millisecond (msec) or an ECG that is unsuitable for QT measurements, for participants with complete right bundle branch block: QTc(F) >=480 msec or an ECG that is unsuitable for QT measurements, ST-T wave abnormalities, clinically significant conduction abnormalities and clinically significant arrhythmias.\n * Smoking history: current smokers or former smokers with a smoking history >= 10 pack years\n * History of alcohol or illegal substance abuse within 2 years prior to Screening (Visit1).\n * Participants at risk of non-compliance, or unable to comply with the study procedures. Participants who are unable to follow study instructions such as visit schedule and paper diary completion. Participants who have known evidence of lack of adherence to controller medication and/or ability to follow physician's recommendations. Any infirmity, disability, or geographic location that would limit compliance for scheduled visits.",{"$nulls":4},"Actual","2018-01-09","Actual","Anticipated","2019-08-14","Anticipated","2018-08-01","2018-01-03","2018-01-03","2018-08-13","No","Asthma Control Questionnaire\nAllergic fungal airway disease\nAsthma Quality of Life Questionnaire\nHolter monitoring\nAsthma","Interventional","Treatment","Parallel Assignment","Double (Participant, Investigator)","Randomized","18 Years",null,"All",null,"No","Yes\nIPD for this study will be made available via the Clinical Study Data Request site.",{"$nulls":3},"No","No",{"$nulls":19},"Change from Baseline in blood eosinophils|Change from Baseline in fractional exhaled nitric oxide (FeNO)","Blood samples will be collected at indicated time points for the assessment of eosinophil|FeNO will be measured using a handheld electronic device","Baseline and up to Day 88","Serum concentrations of GSK3772847|Serum levels of free soluble suppressor of tumorigenicity 2 (ST2)|Serum levels of total soluble ST2|Number of participants with positive result of serum anti-GSK3772847 antibodies post dosing|Titers of serum anti-GSK3772847 antibodies post dosing|Change from Baseline in Asthma Control Questionnaire-5 (ACQ-5) absolute score at Weeks 2, 4, 8 and 12|Change from Baseline in Asthma Quality of Life Questionnaire (AQLQ) total and domain scores at Weeks 2, 4, 8 and 12|Number of responders to ACQ-5|Number of responders to AQLQ|Change from Baseline in forced expiratory volume in 1 second (FEV1)|Change from Baseline in forced vital capacity (FVC)|Number of participants with treatment emergent adverse events (AE) and serious AEs (SAE)|Number of participants with abnormal hematology parameters|Number of participants with abnormal clinical chemistry parameters|Number of participants with abnormal systolic blood pressure (SBP) and diastolic blood pressure (DBP)|Number of participants with abnormal heart rate|Number of participants with abnormal findings in Electrocardiogram (ECG)|Number of participants with abnormal 24-hour Holter findings","Blood samples will be collected at indicated time points for assessment of serum concentrations|Blood samples will be collected at indicated time points to measure free soluble ST2|Blood samples will be collected at indicated time points to measure total soluble ST2|Blood samples will be collected at indicated time points and anti-GSK3772847 antibodies will be assessed using a tiered approach.|ACQ-5 is a 5-item questionnaire that is a measure of the participant's asthma control. The five questions include about the frequency and/or severity of symptoms like nocturnal awakening, activity limitation, shortness of breath and wheeze. The score scales from zero (totally controlled) and 6 (severely uncontrolled)|AQLQ is 32 items four domains questionnaire used for evaluation of impact of asthma treatments on the quality of life of participants. The scores are evaluated from 1 (total impairment) and 7 (no impairment)|ACQ-5 is a 5 question tool used to measure attributes of asthma control and the score ranges from 0 to 6 where 0 is no impairment/limitation and 6 is total impairment/limitation. A responder to ACQ-5 will be defined as a participant who has a decrease from Baseline in ACQ-5 score of 0.5 or more.|AQLQ is a 32 items four domain questionnaire used to measure quality of life participants due to asthma treatment and the scores ranges from 1 to 7 where 1 indicates total impairment and 7 indicates no impairment. A responder to AQLQ will be defined as a participant who has an increase from Baseline in AQLQ score of 0.5 or more.|Spirometry assessment will include pre-bronchodilator FEV1|Spirometry assessment will include pre-bronchodilator FVC|An AE is any untoward medical occurrence in a clinical study participants, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that, at any dose may result in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment.|Laboratory assessment for hematology parameters will include Platelet count, hemoglobin, Red blood cell (RBC) count, hematocrit, Red blood cell distribution width (RDW), RBC indices like mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH) and mean corpuscular hemoglobin concentration (MCHC). White blood cell (WBC) count with differential will include neutrophils, lymphocytes, monocytes, eosinophils and basophils.|Laboratory assessment for clinical chemistry parameters will include blood urea nitrogen (BUN), potassium, calcium, sodium, creatinine, non-fasting glucose, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline phosphate, Gamma-glutamyl transferase (GGT), albumin, phosphorus, carbon dioxide, total protein, creatine phosphokinase (CPK), total and direct bilirubin|Blood pressure will be measured in supine position after 5 minutes rest|Heart rate will be measured in supine position after 5 minutes rest|Single 12-lead ECG will be obtained using an ECG machine that automatically measures heart rate, PR, QRS, QT, and QT interval corrected for heart rate (QTc) and ventricular rate|Holter assessment will be used for quantitative assessment of abnormal rhythm events. Holter monitor will be placed 30-60 minutes prior to dosing.","Day 1 post-end of infusion, Day 15, Pre-dose on Day 29, Pre-dose and post-dose on Day 57, Day 85 and Day 169|Day 1 Pre and post-dose; Day 15; Day 29 Post dose; Day 57 pre and post dose; Day 85, Day 169|Up to Day 172|Baseline and at Weeks 2, 4, 8 and 12|Up to Day 88|Day 1","GSKClinicalSupportHD@gsk.com","US GSK Clinical Trials Call Center","877-379-3718","Brest Cedex, France, 29609|Wythenshawe, Greater Manchester, United Kingdom, M23 9Lt|Leicester, Leicestershire, United Kingdom, Le3 9Qp|Birmingham, United Kingdom, B9 5Ss",null,"France|United Kingdom","Gsk Investigational Site|, Greater Manchester Gsk Investigational Site|, Leicestershire Gsk Investigational Site",{"$nulls":3},"GSK Clinical Trials","2018-08-13","2020-05-25T16:35:49.365","2020-05-26T17:10:42.972","NCT03393806"]
["5ecbf3e511702c1b1b9169fe","NCT03393806","2018-08-21","GlaxoSmithKline","GSK","Recruiting","Repeat Dose Study of GSK3772847 in Participants With Moderate to Severe Asthma With Allergic Fungal Airway Disease (AFAD)","Gsk-3772847",null,"Yes","['Gsk-3772847']","Unknown",null,"Phase 2",2,46,"Anticipated","2018-04-18","2019-05-22",{"$nulls":5},"This study is multicenter, double-blinded parallel group design, where participants with moderate to severe asthma with AFAD will be enrolled. Participants will receive three doses of 10 milligrams/kilogram (mg/kg) of GSK3772847 every 4 Weeks versus placebo along with standard of care. Participants will be randomized in 1:1 ratio to receive either 10 mg/kg GSK3772847 intravenously (IV) or matching placebo IV. Participants will receive study treatment on Week 0 (Day 1), Week 4 and Week 8. The total duration of the study will be 28 Weeks and approximately 46 participants will be randomized.",null,"A Double Blind (Sponsor Open) Placebo-controlled, Stratified, Parallel Group Study to Evaluate the Efficacy and Safety of Repeat Doses of GSK3772847 in Participants With Moderate to Severe Asthma With Allergic Fungal Airway Disease (AFAD)",207972,"Asthma","Asthma","Bronchial Diseases","Respiratory","Experimental|Placebo Comparator","Participants receiving GSK3772847|Participants receiving placebo","Participants will be randomized to receive GSK3772847 as IV infusion. Participants will receive three doses ( Day 1, Day 29 and Day 57) of GSK3772847 every 4 weeks|Participants will be randomized to receive matching placebo as IV infusion","Drug","GSK3772847|Placebo","GSK3772847 will be available as 100 mg/vial, white to yellow, uniform lyophilized cake in a 5 milliliter (mL) clear glass vial with closure sealed by red metal and yellow overseal.|Commercially sourced sterile normal saline will be provided as Placebo",null,"Participants receiving GSK3772847|Participants receiving placebo","\n\n * Participant must be at least 18 years of age inclusive, at the time of signing the informed consent.\n * Documented history of physician diagnosed moderate or severe asthma for >=12 months based on Guidelines and treated with inhaled corticosteroid (ICS) and long-acting beta-2-agonist (LABA) for at least 4 months (>=500 micrograms/day [Âµg/day]) fluticasone propionate or equivalent as defined in the guidelines.\n * Pre-bronchodilator FEV1 35-79% of predicted value for participant inclusive\n * FeNO >= 25 parts per billion (ppb) at Screening\n * ACQ-5 score >= 1.5 at Screening\n * Blood eosinophil >=300 cells/microliter at Screening\n * Evidence of allergic fungal airway disease like Fungal sensitization to any of the fungi Aspergillus fumigatus, Penicillium chrysogenum (notatum) at screening measured by serum-specific Immunoglobulin (Ig) E test. A history of exacerbations with at least 1 severe exacerbation (defined as requiring a minimum of 3 days of high-dose oral corticosteroids for asthma symptoms) in the previous 12 months.\n * Body weight within 50-150 kilogram (kg)\n * Both male and female gender. A female participant is eligible to participate if she is not pregnant not breastfeeding, Not a woman of childbearing potential (WOCBP) or A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 16 weeks after the last dose of study treatment.\n * Capable of giving signed informed consent\n\n","\n\n * Historical diagnosis of cystic fibrosis\n * Concurrent respiratory diseases: Presence of a known pre-existing, clinically important respiratory conditions (example pneumonia, pneumothorax, atelectasis segmental or larger, pulmonary fibrotic disease, bronchopulmonary dysplasia, chronic bronchitis, emphysema, chronic obstructive pulmonary disease, or other respiratory abnormalities) other than asthma or AFAD\n * Has a history of chronic or recurrent non-pulmonary infectious disease or ongoing non-pulmonary infection including, but not limited to, chronic renal infection, chronic chest infection, recurrent urinary tract infection (example, recurrent pyelonephritis, chronic non-remitting cystitis), or open, draining skin wound or an ulcer\n * Serious infection within 8 weeks of enrolment, including, but not limited to hepatitis, pneumonia, sepsis, or pyelonephritis; or has been hospitalized for an infection; or has been treated with IV antibiotics for an infection, within 8 weeks prior to the first administration of study drug.\n * Evidence of poorly controlled chronic medical conditions other than asthma, example, participants with known, pre-existing, clinically significant endocrine, autoimmune, metabolic, neurological, renal, cardiovascular, gastrointestinal, hepatic, and hematological or any other system abnormalities that are uncontrolled with standard treatment.\n * Cardiovascular disease: Clinically significant organic heart disease\n * Participants with a diagnosis of malignancy or in the process of investigation for a malignancy. Participants with carcinoma that have not been in complete remission for at least 5 years. Participants who have had carcinoma in situ of the cervix, squamous cell carcinoma and basal cell carcinoma of the skin would not be excluded based on the 5 year waiting period if the participant has been considered cured by treatment.\n * Eosinophilic diseases: Other conditions that could lead to elevated eosinophil such as hyper-eosinophilic syndromes. Participants with a known, pre-existing parasitic infestation within 6 months prior to Screening (Visit 1)\n * Prohibited medications is not permitted within the defined time intervals prior to Screening (Visit 1) and throughout the study.\n * Presence of hepatitis B surface antigen (HBsAg), positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study treatment.\n * A known immunodeficiency such as human immunodeficiency virus infection.\n * Hypersensitivity: significant allergies to humanized monoclonal antibodies or biologic or to any components of the formulation used in this study\n * Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear Ig A dermatosis, toxic epidermal necrolysis, and exfoliative dermatitis).\n * Clinically significant abnormality on 12-lead ECG assessment at screening (Visit 1). Site investigators will be provided with ECG over-read conducted by a centralized independent cardiologist, to assist in evaluation of participant eligibility.\n * Sinus bradycardia <45 beats per minute (bpm), sinus tachycardia >= 110 bpm, multifocal atrial tachycardia (wandering atrial pacemaker with rate >100bpm), evidence of Mobitz II second degree or third degree atrioventricular (AV) block, pathological Q waves (defined as wide [>0.04 seconds] and deep [>0.4 millivolts (mV) (4 millimeter [mm] with 10mm/mV setting)] or >25% of the height of the corresponding R wave, providing the R wave was >0.5mV [5mm with 10mm/mV setting], appearing in at least two contiguous leads, evidence of ventricular ectopic couplets, bigeminy, trigeminy or multifocal premature ventricular complexes, for participants without complete right bundle branch block: QTc for heart rate by Fridericia's formula QTc(F) >= 450 millisecond (msec) or an ECG that is unsuitable for QT measurements, for participants with complete right bundle branch block: QTc(F) >=480 msec or an ECG that is unsuitable for QT measurements, ST-T wave abnormalities, clinically significant conduction abnormalities and clinically significant arrhythmias.\n * Smoking history: current smokers or former smokers with a smoking history >= 10 pack years\n * History of alcohol or illegal substance abuse within 2 years prior to Screening (Visit1).\n * Participants at risk of non-compliance, or unable to comply with the study procedures. Participants who are unable to follow study instructions such as visit schedule and paper diary completion. Participants who have known evidence of lack of adherence to controller medication and/or ability to follow physician's recommendations. Any infirmity, disability, or geographic location that would limit compliance for scheduled visits.",{"$nulls":4},"Actual","2018-01-09","Actual","Anticipated","2019-08-14","Anticipated","2018-08-01","2018-01-03","2018-01-03","2018-08-20","No","Asthma Control Questionnaire\nAllergic fungal airway disease\nAsthma Quality of Life Questionnaire\nHolter monitoring\nAsthma","Interventional","Treatment","Parallel Assignment","Double (Participant, Investigator)","Randomized","18 Years",null,"All",null,"No","Yes\nIPD for this study will be made available via the Clinical Study Data Request site.",{"$nulls":3},"No","No",{"$nulls":19},"Change from Baseline in blood eosinophils|Change from Baseline in fractional exhaled nitric oxide (FeNO)","Blood samples will be collected at indicated time points for the assessment of eosinophil|FeNO will be measured using a handheld electronic device","Baseline and up to Day 88","Serum concentrations of GSK3772847|Serum levels of free soluble suppressor of tumorigenicity 2 (ST2)|Serum levels of total soluble ST2|Number of participants with positive result of serum anti-GSK3772847 antibodies post dosing|Titers of serum anti-GSK3772847 antibodies post dosing|Change from Baseline in Asthma Control Questionnaire-5 (ACQ-5) absolute score at Weeks 2, 4, 8 and 12|Change from Baseline in Asthma Quality of Life Questionnaire (AQLQ) total and domain scores at Weeks 2, 4, 8 and 12|Number of responders to ACQ-5|Number of responders to AQLQ|Change from Baseline in forced expiratory volume in 1 second (FEV1)|Change from Baseline in forced vital capacity (FVC)|Number of participants with treatment emergent adverse events (AE) and serious AEs (SAE)|Number of participants with abnormal hematology parameters|Number of participants with abnormal clinical chemistry parameters|Number of participants with abnormal systolic blood pressure (SBP) and diastolic blood pressure (DBP)|Number of participants with abnormal heart rate|Number of participants with abnormal findings in Electrocardiogram (ECG)|Number of participants with abnormal 24-hour Holter findings","Blood samples will be collected at indicated time points for assessment of serum concentrations|Blood samples will be collected at indicated time points to measure free soluble ST2|Blood samples will be collected at indicated time points to measure total soluble ST2|Blood samples will be collected at indicated time points and anti-GSK3772847 antibodies will be assessed using a tiered approach.|ACQ-5 is a 5-item questionnaire that is a measure of the participant's asthma control. The five questions include about the frequency and/or severity of symptoms like nocturnal awakening, activity limitation, shortness of breath and wheeze. The score scales from zero (totally controlled) and 6 (severely uncontrolled)|AQLQ is 32 items four domains questionnaire used for evaluation of impact of asthma treatments on the quality of life of participants. The scores are evaluated from 1 (total impairment) and 7 (no impairment)|ACQ-5 is a 5 question tool used to measure attributes of asthma control and the score ranges from 0 to 6 where 0 is no impairment/limitation and 6 is total impairment/limitation. A responder to ACQ-5 will be defined as a participant who has a decrease from Baseline in ACQ-5 score of 0.5 or more.|AQLQ is a 32 items four domain questionnaire used to measure quality of life participants due to asthma treatment and the scores ranges from 1 to 7 where 1 indicates total impairment and 7 indicates no impairment. A responder to AQLQ will be defined as a participant who has an increase from Baseline in AQLQ score of 0.5 or more.|Spirometry assessment will include pre-bronchodilator FEV1|Spirometry assessment will include pre-bronchodilator FVC|An AE is any untoward medical occurrence in a clinical study participants, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that, at any dose may result in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment.|Laboratory assessment for hematology parameters will include Platelet count, hemoglobin, Red blood cell (RBC) count, hematocrit, Red blood cell distribution width (RDW), RBC indices like mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH) and mean corpuscular hemoglobin concentration (MCHC). White blood cell (WBC) count with differential will include neutrophils, lymphocytes, monocytes, eosinophils and basophils.|Laboratory assessment for clinical chemistry parameters will include blood urea nitrogen (BUN), potassium, calcium, sodium, creatinine, non-fasting glucose, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline phosphate, Gamma-glutamyl transferase (GGT), albumin, phosphorus, carbon dioxide, total protein, creatine phosphokinase (CPK), total and direct bilirubin|Blood pressure will be measured in supine position after 5 minutes rest|Heart rate will be measured in supine position after 5 minutes rest|Single 12-lead ECG will be obtained using an ECG machine that automatically measures heart rate, PR, QRS, QT, and QT interval corrected for heart rate (QTc) and ventricular rate|Holter assessment will be used for quantitative assessment of abnormal rhythm events. Holter monitor will be placed 30-60 minutes prior to dosing.","Day 1 post-end of infusion, Day 15, Pre-dose on Day 29, Pre-dose and post-dose on Day 57, Day 85 and Day 169|Day 1 Pre and post-dose; Day 15; Day 29 Post dose; Day 57 pre and post dose; Day 85, Day 169|Up to Day 172|Baseline and at Weeks 2, 4, 8 and 12|Up to Day 88|Day 1","GSKClinicalSupportHD@gsk.com","US GSK Clinical Trials Call Center","877-379-3718","Brest Cedex, France, 29609|Wythenshawe, Greater Manchester, United Kingdom, M23 9Lt|Leicester, Leicestershire, United Kingdom, Le3 9Qp|Birmingham, United Kingdom, B9 5Ss",null,"France|United Kingdom","Gsk Investigational Site|, Greater Manchester Gsk Investigational Site|, Leicestershire Gsk Investigational Site",{"$nulls":3},"GSK Clinical Trials","2018-08-20","2020-05-25T16:35:49.621","2020-05-26T17:10:42.972","NCT03393806"]
["5ecbf3e6e2561b1b11905ce8","NCT03393806","2018-09-05","GlaxoSmithKline","GSK","Recruiting","Repeat Dose Study of GSK3772847 in Participants With Moderate to Severe Asthma With Allergic Fungal Airway Disease (AFAD)","Gsk-3772847",null,"Yes","['Gsk-3772847']","Unknown",null,"Phase 2",2,46,"Anticipated","2018-04-18","2019-05-22",{"$nulls":5},"This study is multicenter, double-blinded parallel group design, where participants with moderate to severe asthma with AFAD will be enrolled. Participants will receive three doses of 10 milligrams/kilogram (mg/kg) of GSK3772847 every 4 Weeks versus placebo along with standard of care. Participants will be randomized in 1:1 ratio to receive either 10 mg/kg GSK3772847 intravenously (IV) or matching placebo IV. Participants will receive study treatment on Week 0 (Day 1), Week 4 and Week 8. The total duration of the study will be 28 Weeks and approximately 46 participants will be randomized.",null,"A Double Blind (Sponsor Open) Placebo-controlled, Stratified, Parallel Group Study to Evaluate the Efficacy and Safety of Repeat Doses of GSK3772847 in Participants With Moderate to Severe Asthma With Allergic Fungal Airway Disease (AFAD)",207972,"Asthma","Asthma","Bronchial Diseases","Respiratory","Experimental|Placebo Comparator","Participants receiving GSK3772847|Participants receiving placebo","Participants will be randomized to receive GSK3772847 as IV infusion. Participants will receive three doses ( Day 1, Day 29 and Day 57) of GSK3772847 every 4 weeks|Participants will be randomized to receive matching placebo as IV infusion","Drug","GSK3772847|Placebo","GSK3772847 will be available as 100 mg/vial, white to yellow, uniform lyophilized cake in a 5 milliliter (mL) clear glass vial with closure sealed by red metal and yellow overseal.|Commercially sourced sterile normal saline will be provided as Placebo",null,"Participants receiving GSK3772847|Participants receiving placebo","\n\n * Participant must be at least 18 years of age inclusive, at the time of signing the informed consent.\n * Documented history of physician diagnosed moderate or severe asthma for >=12 months based on Guidelines and treated with inhaled corticosteroid (ICS) and long-acting beta-2-agonist (LABA) for at least 4 months (>=500 micrograms/day [Âµg/day]) fluticasone propionate or equivalent as defined in the guidelines.\n * Pre-bronchodilator FEV1 35-79% of predicted value for participant inclusive\n * FeNO >= 25 parts per billion (ppb) at Screening\n * ACQ-5 score >= 1.5 at Screening\n * Blood eosinophil >=300 cells/microliter at Screening\n * Evidence of allergic fungal airway disease like Fungal sensitization to any of the fungi Aspergillus fumigatus, Penicillium chrysogenum (notatum) at screening measured by serum-specific Immunoglobulin (Ig) E test. A history of exacerbations with at least 1 severe exacerbation (defined as requiring a minimum of 3 days of high-dose oral corticosteroids for asthma symptoms) in the previous 12 months.\n * Body weight within 50-150 kilogram (kg)\n * Both male and female gender. A female participant is eligible to participate if she is not pregnant not breastfeeding, Not a woman of childbearing potential (WOCBP) or A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 16 weeks after the last dose of study treatment.\n * Capable of giving signed informed consent\n\n","\n\n * Historical diagnosis of cystic fibrosis\n * Concurrent respiratory diseases: Presence of a known pre-existing, clinically important respiratory conditions (example pneumonia, pneumothorax, atelectasis segmental or larger, pulmonary fibrotic disease, bronchopulmonary dysplasia, chronic bronchitis, emphysema, chronic obstructive pulmonary disease, or other respiratory abnormalities) other than asthma or AFAD\n * Has a history of chronic or recurrent non-pulmonary infectious disease or ongoing non-pulmonary infection including, but not limited to, chronic renal infection, chronic chest infection, recurrent urinary tract infection (example, recurrent pyelonephritis, chronic non-remitting cystitis), or open, draining skin wound or an ulcer\n * Serious infection within 8 weeks of enrolment, including, but not limited to hepatitis, pneumonia, sepsis, or pyelonephritis; or has been hospitalized for an infection; or has been treated with IV antibiotics for an infection, within 8 weeks prior to the first administration of study drug.\n * Evidence of poorly controlled chronic medical conditions other than asthma, example, participants with known, pre-existing, clinically significant endocrine, autoimmune, metabolic, neurological, renal, cardiovascular, gastrointestinal, hepatic, and hematological or any other system abnormalities that are uncontrolled with standard treatment.\n * Cardiovascular disease: Clinically significant organic heart disease\n * Participants with a diagnosis of malignancy or in the process of investigation for a malignancy. Participants with carcinoma that have not been in complete remission for at least 5 years. Participants who have had carcinoma in situ of the cervix, squamous cell carcinoma and basal cell carcinoma of the skin would not be excluded based on the 5 year waiting period if the participant has been considered cured by treatment.\n * Eosinophilic diseases: Other conditions that could lead to elevated eosinophil such as hyper-eosinophilic syndromes. Participants with a known, pre-existing parasitic infestation within 6 months prior to Screening (Visit 1)\n * Prohibited medications is not permitted within the defined time intervals prior to Screening (Visit 1) and throughout the study.\n * Presence of hepatitis B surface antigen (HBsAg), positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study treatment.\n * A known immunodeficiency such as human immunodeficiency virus infection.\n * Hypersensitivity: significant allergies to humanized monoclonal antibodies or biologic or to any components of the formulation used in this study\n * Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear Ig A dermatosis, toxic epidermal necrolysis, and exfoliative dermatitis).\n * Clinically significant abnormality on 12-lead ECG assessment at screening (Visit 1). Site investigators will be provided with ECG over-read conducted by a centralized independent cardiologist, to assist in evaluation of participant eligibility.\n * Sinus bradycardia <45 beats per minute (bpm), sinus tachycardia >= 110 bpm, multifocal atrial tachycardia (wandering atrial pacemaker with rate >100bpm), evidence of Mobitz II second degree or third degree atrioventricular (AV) block, pathological Q waves (defined as wide [>0.04 seconds] and deep [>0.4 millivolts (mV) (4 millimeter [mm] with 10mm/mV setting)] or >25% of the height of the corresponding R wave, providing the R wave was >0.5mV [5mm with 10mm/mV setting], appearing in at least two contiguous leads, evidence of ventricular ectopic couplets, bigeminy, trigeminy or multifocal premature ventricular complexes, for participants without complete right bundle branch block: QTc for heart rate by Fridericia's formula QTc(F) >= 450 millisecond (msec) or an ECG that is unsuitable for QT measurements, for participants with complete right bundle branch block: QTc(F) >=480 msec or an ECG that is unsuitable for QT measurements, ST-T wave abnormalities, clinically significant conduction abnormalities and clinically significant arrhythmias.\n * Smoking history: current smokers or former smokers with a smoking history >= 10 pack years\n * History of alcohol or illegal substance abuse within 2 years prior to Screening (Visit1).\n * Participants at risk of non-compliance, or unable to comply with the study procedures. Participants who are unable to follow study instructions such as visit schedule and paper diary completion. Participants who have known evidence of lack of adherence to controller medication and/or ability to follow physician's recommendations. Any infirmity, disability, or geographic location that would limit compliance for scheduled visits.",{"$nulls":4},"Actual","2018-01-09","Actual","Anticipated","2019-08-14","Anticipated","2018-09-01","2018-01-03","2018-01-03","2018-09-04","No","Asthma Control Questionnaire\nAllergic fungal airway disease\nAsthma Quality of Life Questionnaire\nHolter monitoring\nAsthma","Interventional","Treatment","Parallel Assignment","Double (Participant, Investigator)","Randomized","18 Years",null,"All",null,"No","Yes\nIPD for this study will be made available via the Clinical Study Data Request site.",{"$nulls":3},"No","No",{"$nulls":19},"Change from Baseline in blood eosinophils|Change from Baseline in fractional exhaled nitric oxide (FeNO)","Blood samples will be collected at indicated time points for the assessment of eosinophil|FeNO will be measured using a handheld electronic device","Baseline and up to Day 88","Serum concentrations of GSK3772847|Serum levels of free soluble suppressor of tumorigenicity 2 (ST2)|Serum levels of total soluble ST2|Number of participants with positive result of serum anti-GSK3772847 antibodies post dosing|Titers of serum anti-GSK3772847 antibodies post dosing|Change from Baseline in Asthma Control Questionnaire-5 (ACQ-5) absolute score at Weeks 2, 4, 8 and 12|Change from Baseline in Asthma Quality of Life Questionnaire (AQLQ) total and domain scores at Weeks 2, 4, 8 and 12|Number of responders to ACQ-5|Number of responders to AQLQ|Change from Baseline in forced expiratory volume in 1 second (FEV1)|Change from Baseline in forced vital capacity (FVC)|Number of participants with treatment emergent adverse events (AE) and serious AEs (SAE)|Number of participants with abnormal hematology parameters|Number of participants with abnormal clinical chemistry parameters|Number of participants with abnormal systolic blood pressure (SBP) and diastolic blood pressure (DBP)|Number of participants with abnormal heart rate|Number of participants with abnormal findings in Electrocardiogram (ECG)|Number of participants with abnormal 24-hour Holter findings","Blood samples will be collected at indicated time points for assessment of serum concentrations|Blood samples will be collected at indicated time points to measure free soluble ST2|Blood samples will be collected at indicated time points to measure total soluble ST2|Blood samples will be collected at indicated time points and anti-GSK3772847 antibodies will be assessed using a tiered approach.|ACQ-5 is a 5-item questionnaire that is a measure of the participant's asthma control. The five questions include about the frequency and/or severity of symptoms like nocturnal awakening, activity limitation, shortness of breath and wheeze. The score scales from zero (totally controlled) and 6 (severely uncontrolled)|AQLQ is 32 items four domains questionnaire used for evaluation of impact of asthma treatments on the quality of life of participants. The scores are evaluated from 1 (total impairment) and 7 (no impairment)|ACQ-5 is a 5 question tool used to measure attributes of asthma control and the score ranges from 0 to 6 where 0 is no impairment/limitation and 6 is total impairment/limitation. A responder to ACQ-5 will be defined as a participant who has a decrease from Baseline in ACQ-5 score of 0.5 or more.|AQLQ is a 32 items four domain questionnaire used to measure quality of life participants due to asthma treatment and the scores ranges from 1 to 7 where 1 indicates total impairment and 7 indicates no impairment. A responder to AQLQ will be defined as a participant who has an increase from Baseline in AQLQ score of 0.5 or more.|Spirometry assessment will include pre-bronchodilator FEV1|Spirometry assessment will include pre-bronchodilator FVC|An AE is any untoward medical occurrence in a clinical study participants, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that, at any dose may result in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment.|Laboratory assessment for hematology parameters will include Platelet count, hemoglobin, Red blood cell (RBC) count, hematocrit, Red blood cell distribution width (RDW), RBC indices like mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH) and mean corpuscular hemoglobin concentration (MCHC). White blood cell (WBC) count with differential will include neutrophils, lymphocytes, monocytes, eosinophils and basophils.|Laboratory assessment for clinical chemistry parameters will include blood urea nitrogen (BUN), potassium, calcium, sodium, creatinine, non-fasting glucose, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline phosphate, Gamma-glutamyl transferase (GGT), albumin, phosphorus, carbon dioxide, total protein, creatine phosphokinase (CPK), total and direct bilirubin|Blood pressure will be measured in supine position after 5 minutes rest|Heart rate will be measured in supine position after 5 minutes rest|Single 12-lead ECG will be obtained using an ECG machine that automatically measures heart rate, PR, QRS, QT, and QT interval corrected for heart rate (QTc) and ventricular rate|Holter assessment will be used for quantitative assessment of abnormal rhythm events. Holter monitor will be placed 30-60 minutes prior to dosing.","Day 1 post-end of infusion, Day 15, Pre-dose on Day 29, Pre-dose and post-dose on Day 57, Day 85 and Day 169|Day 1 Pre and post-dose; Day 15; Day 29 Post dose; Day 57 pre and post dose; Day 85, Day 169|Up to Day 172|Baseline and at Weeks 2, 4, 8 and 12|Up to Day 88|Day 1","GSKClinicalSupportHD@gsk.com","US GSK Clinical Trials Call Center","877-379-3718","Brest Cedex, France, 29609|Amsterdam, Netherlands, 1105 Az|Wythenshawe, Greater Manchester, United Kingdom, M23 9Lt|Leicester, Leicestershire, United Kingdom, Le3 9Qp|Birmingham, United Kingdom, B9 5Ss",null,"France|Netherlands|United Kingdom","Gsk Investigational Site|, Greater Manchester Gsk Investigational Site|, Leicestershire Gsk Investigational Site",{"$nulls":3},"GSK Clinical Trials","2018-09-04","2020-05-25T16:35:50.189","2020-05-26T17:10:42.972","NCT03393806"]
["5ecbf3e611702c1b1b9169ff","NCT03393806","2018-09-28","GlaxoSmithKline","GSK","Recruiting","Repeat Dose Study of GSK3772847 in Participants With Moderate to Severe Asthma With Allergic Fungal Airway Disease (AFAD)","Gsk-3772847",null,"Yes","['Gsk-3772847']","Unknown",null,"Phase 2",2,46,"Anticipated","2018-04-18","2019-05-22",{"$nulls":5},"This study is multicenter, double-blinded parallel group design, where participants with moderate to severe asthma with AFAD will be enrolled. Participants will receive three doses of 10 milligrams/kilogram (mg/kg) of GSK3772847 every 4 Weeks versus placebo along with standard of care. Participants will be randomized in 1:1 ratio to receive either 10 mg/kg GSK3772847 intravenously (IV) or matching placebo IV. Participants will receive study treatment on Week 0 (Day 1), Week 4 and Week 8. The total duration of the study will be 28 Weeks and approximately 46 participants will be randomized.",null,"A Double Blind (Sponsor Open) Placebo-controlled, Stratified, Parallel Group Study to Evaluate the Efficacy and Safety of Repeat Doses of GSK3772847 in Participants With Moderate to Severe Asthma With Allergic Fungal Airway Disease (AFAD)",207972,"Asthma","Asthma","Bronchial Diseases","Respiratory","Experimental|Placebo Comparator","Participants receiving GSK3772847|Participants receiving placebo","Participants will be randomized to receive GSK3772847 as IV infusion. Participants will receive three doses ( Day 1, Day 29 and Day 57) of GSK3772847 every 4 weeks|Participants will be randomized to receive matching placebo as IV infusion","Drug","GSK3772847|Placebo","GSK3772847 will be available as 100 mg/vial, white to yellow, uniform lyophilized cake in a 5 milliliter (mL) clear glass vial with closure sealed by red metal and yellow overseal.|Commercially sourced sterile normal saline will be provided as Placebo",null,"Participants receiving GSK3772847|Participants receiving placebo","\n\n * Participant must be at least 18 years of age inclusive, at the time of signing the informed consent.\n * Documented history of physician diagnosed moderate or severe asthma for >=12 months based on Guidelines and treated with inhaled corticosteroid (ICS) and long-acting beta-2-agonist (LABA) for at least 4 months (>=500 micrograms/day [Âµg/day]) fluticasone propionate or equivalent as defined in the guidelines.\n * Pre-bronchodilator FEV1 35-79% of predicted value for participant inclusive\n * FeNO >= 25 parts per billion (ppb) at Screening\n * ACQ-5 score >= 1.5 at Screening\n * Blood eosinophil >=300 cells/microliter at Screening\n * Evidence of allergic fungal airway disease like Fungal sensitization to any of the fungi Aspergillus fumigatus, Penicillium chrysogenum (notatum) at screening measured by serum-specific Immunoglobulin (Ig) E test. A history of exacerbations with at least 1 severe exacerbation (defined as requiring a minimum of 3 days of high-dose oral corticosteroids for asthma symptoms) in the previous 12 months.\n * Body weight within 50-150 kilogram (kg)\n * Both male and female gender. A female participant is eligible to participate if she is not pregnant not breastfeeding, Not a woman of childbearing potential (WOCBP) or A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 16 weeks after the last dose of study treatment.\n * Capable of giving signed informed consent\n\n","\n\n * Historical diagnosis of cystic fibrosis\n * Concurrent respiratory diseases: Presence of a known pre-existing, clinically important respiratory conditions (example pneumonia, pneumothorax, atelectasis segmental or larger, pulmonary fibrotic disease, bronchopulmonary dysplasia, chronic bronchitis, emphysema, chronic obstructive pulmonary disease, or other respiratory abnormalities) other than asthma or AFAD\n * Has a history of chronic or recurrent non-pulmonary infectious disease or ongoing non-pulmonary infection including, but not limited to, chronic renal infection, chronic chest infection, recurrent urinary tract infection (example, recurrent pyelonephritis, chronic non-remitting cystitis), or open, draining skin wound or an ulcer\n * Serious infection within 8 weeks of enrolment, including, but not limited to hepatitis, pneumonia, sepsis, or pyelonephritis; or has been hospitalized for an infection; or has been treated with IV antibiotics for an infection, within 8 weeks prior to the first administration of study drug.\n * Evidence of poorly controlled chronic medical conditions other than asthma, example, participants with known, pre-existing, clinically significant endocrine, autoimmune, metabolic, neurological, renal, cardiovascular, gastrointestinal, hepatic, and hematological or any other system abnormalities that are uncontrolled with standard treatment.\n * Cardiovascular disease: Clinically significant organic heart disease\n * Participants with a diagnosis of malignancy or in the process of investigation for a malignancy. Participants with carcinoma that have not been in complete remission for at least 5 years. Participants who have had carcinoma in situ of the cervix, squamous cell carcinoma and basal cell carcinoma of the skin would not be excluded based on the 5 year waiting period if the participant has been considered cured by treatment.\n * Eosinophilic diseases: Other conditions that could lead to elevated eosinophil such as hyper-eosinophilic syndromes. Participants with a known, pre-existing parasitic infestation within 6 months prior to Screening (Visit 1)\n * Prohibited medications is not permitted within the defined time intervals prior to Screening (Visit 1) and throughout the study.\n * Presence of hepatitis B surface antigen (HBsAg), positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study treatment.\n * A known immunodeficiency such as human immunodeficiency virus infection.\n * Hypersensitivity: significant allergies to humanized monoclonal antibodies or biologic or to any components of the formulation used in this study\n * Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear Ig A dermatosis, toxic epidermal necrolysis, and exfoliative dermatitis).\n * Clinically significant abnormality on 12-lead ECG assessment at screening (Visit 1). Site investigators will be provided with ECG over-read conducted by a centralized independent cardiologist, to assist in evaluation of participant eligibility.\n * Sinus bradycardia <45 beats per minute (bpm), sinus tachycardia >= 110 bpm, multifocal atrial tachycardia (wandering atrial pacemaker with rate >100bpm), evidence of Mobitz II second degree or third degree atrioventricular (AV) block, pathological Q waves (defined as wide [>0.04 seconds] and deep [>0.4 millivolts (mV) (4 millimeter [mm] with 10mm/mV setting)] or >25% of the height of the corresponding R wave, providing the R wave was >0.5mV [5mm with 10mm/mV setting], appearing in at least two contiguous leads, evidence of ventricular ectopic couplets, bigeminy, trigeminy or multifocal premature ventricular complexes, for participants without complete right bundle branch block: QTc for heart rate by Fridericia's formula QTc(F) >= 450 millisecond (msec) or an ECG that is unsuitable for QT measurements, for participants with complete right bundle branch block: QTc(F) >=480 msec or an ECG that is unsuitable for QT measurements, ST-T wave abnormalities, clinically significant conduction abnormalities and clinically significant arrhythmias.\n * Smoking history: current smokers or former smokers with a smoking history >= 10 pack years\n * History of alcohol or illegal substance abuse within 2 years prior to Screening (Visit1).\n * Participants at risk of non-compliance, or unable to comply with the study procedures. Participants who are unable to follow study instructions such as visit schedule and paper diary completion. Participants who have known evidence of lack of adherence to controller medication and/or ability to follow physician's recommendations. Any infirmity, disability, or geographic location that would limit compliance for scheduled visits.",{"$nulls":4},"Actual","2018-01-09","Actual","Anticipated","2019-08-14","Anticipated","2018-09-01","2018-01-03","2018-01-03","2018-09-27","No","Asthma Control Questionnaire\nAllergic fungal airway disease\nAsthma Quality of Life Questionnaire\nHolter monitoring\nAsthma","Interventional","Treatment","Parallel Assignment","Double (Participant, Investigator)","Randomized","18 Years",null,"All",null,"No","Yes\nIPD for this study will be made available via the Clinical Study Data Request site.",{"$nulls":3},"No","No",{"$nulls":19},"Change from Baseline in blood eosinophils|Change from Baseline in fractional exhaled nitric oxide (FeNO)","Blood samples will be collected at indicated time points for the assessment of eosinophil|FeNO will be measured using a handheld electronic device","Baseline and up to Day 88","Serum concentrations of GSK3772847|Serum levels of free soluble suppressor of tumorigenicity 2 (ST2)|Serum levels of total soluble ST2|Number of participants with positive result of serum anti-GSK3772847 antibodies post dosing|Titers of serum anti-GSK3772847 antibodies post dosing|Change from Baseline in Asthma Control Questionnaire-5 (ACQ-5) absolute score at Weeks 2, 4, 8 and 12|Change from Baseline in Asthma Quality of Life Questionnaire (AQLQ) total and domain scores at Weeks 2, 4, 8 and 12|Number of responders to ACQ-5|Number of responders to AQLQ|Change from Baseline in forced expiratory volume in 1 second (FEV1)|Change from Baseline in forced vital capacity (FVC)|Number of participants with treatment emergent adverse events (AE) and serious AEs (SAE)|Number of participants with abnormal hematology parameters|Number of participants with abnormal clinical chemistry parameters|Number of participants with abnormal systolic blood pressure (SBP) and diastolic blood pressure (DBP)|Number of participants with abnormal heart rate|Number of participants with abnormal findings in Electrocardiogram (ECG)|Number of participants with abnormal 24-hour Holter findings","Blood samples will be collected at indicated time points for assessment of serum concentrations|Blood samples will be collected at indicated time points to measure free soluble ST2|Blood samples will be collected at indicated time points to measure total soluble ST2|Blood samples will be collected at indicated time points and anti-GSK3772847 antibodies will be assessed using a tiered approach.|ACQ-5 is a 5-item questionnaire that is a measure of the participant's asthma control. The five questions include about the frequency and/or severity of symptoms like nocturnal awakening, activity limitation, shortness of breath and wheeze. The score scales from zero (totally controlled) and 6 (severely uncontrolled)|AQLQ is 32 items four domains questionnaire used for evaluation of impact of asthma treatments on the quality of life of participants. The scores are evaluated from 1 (total impairment) and 7 (no impairment)|ACQ-5 is a 5 question tool used to measure attributes of asthma control and the score ranges from 0 to 6 where 0 is no impairment/limitation and 6 is total impairment/limitation. A responder to ACQ-5 will be defined as a participant who has a decrease from Baseline in ACQ-5 score of 0.5 or more.|AQLQ is a 32 items four domain questionnaire used to measure quality of life participants due to asthma treatment and the scores ranges from 1 to 7 where 1 indicates total impairment and 7 indicates no impairment. A responder to AQLQ will be defined as a participant who has an increase from Baseline in AQLQ score of 0.5 or more.|Spirometry assessment will include pre-bronchodilator FEV1|Spirometry assessment will include pre-bronchodilator FVC|An AE is any untoward medical occurrence in a clinical study participants, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that, at any dose may result in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment.|Laboratory assessment for hematology parameters will include Platelet count, hemoglobin, Red blood cell (RBC) count, hematocrit, Red blood cell distribution width (RDW), RBC indices like mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH) and mean corpuscular hemoglobin concentration (MCHC). White blood cell (WBC) count with differential will include neutrophils, lymphocytes, monocytes, eosinophils and basophils.|Laboratory assessment for clinical chemistry parameters will include blood urea nitrogen (BUN), potassium, calcium, sodium, creatinine, non-fasting glucose, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline phosphate, Gamma-glutamyl transferase (GGT), albumin, phosphorus, carbon dioxide, total protein, creatine phosphokinase (CPK), total and direct bilirubin|Blood pressure will be measured in supine position after 5 minutes rest|Heart rate will be measured in supine position after 5 minutes rest|Single 12-lead ECG will be obtained using an ECG machine that automatically measures heart rate, PR, QRS, QT, and QT interval corrected for heart rate (QTc) and ventricular rate|Holter assessment will be used for quantitative assessment of abnormal rhythm events. Holter monitor will be placed 30-60 minutes prior to dosing.","Day 1 post-end of infusion, Day 15, Pre-dose on Day 29, Pre-dose and post-dose on Day 57, Day 85 and Day 169|Day 1 Pre and post-dose; Day 15; Day 29 Post dose; Day 57 pre and post dose; Day 85, Day 169|Up to Day 172|Baseline and at Weeks 2, 4, 8 and 12|Up to Day 88|Day 1","GSKClinicalSupportHD@gsk.com","US GSK Clinical Trials Call Center","877-379-3718","Brest Cedex, France, 29609|Amsterdam, Netherlands, 1105 Az|Wythenshawe, Greater Manchester, United Kingdom, M23 9Lt|Leicester, Leicestershire, United Kingdom, Le3 9Qp|Birmingham, United Kingdom, B9 5Ss",null,"France|Netherlands|United Kingdom","Gsk Investigational Site|, Greater Manchester Gsk Investigational Site|, Leicestershire Gsk Investigational Site",{"$nulls":3},"GSK Clinical Trials","2018-09-27","2020-05-25T16:35:50.282","2020-05-26T17:10:42.972","NCT03393806"]
["5ecbf3e6feab101b1553081c","NCT03393806","2018-10-03","GlaxoSmithKline","GSK","Recruiting","Repeat Dose Study of GSK3772847 in Participants With Moderate to Severe Asthma With Allergic Fungal Airway Disease (AFAD)","Gsk-3772847",null,"Yes","['Gsk-3772847']","Unknown",null,"Phase 2",2,46,"Anticipated","2018-04-18","2019-07-18",{"$nulls":5},"This study is multicenter, double-blinded parallel group design, where participants with moderate to severe asthma with AFAD will be enrolled. Participants will receive three doses of 10 milligrams/kilogram (mg/kg) of GSK3772847 every 4 Weeks versus placebo along with standard of care. Participants will be randomized in 1:1 ratio to receive either 10 mg/kg GSK3772847 intravenously (IV) or matching placebo IV. Participants will receive study treatment on Week 0 (Day 1), Week 4 and Week 8. The total duration of the study will be 28 Weeks and approximately 46 participants will be randomized.",null,"A Double Blind (Sponsor Open) Placebo-controlled, Stratified, Parallel Group Study to Evaluate the Efficacy and Safety of Repeat Doses of GSK3772847 in Participants With Moderate to Severe Asthma With Allergic Fungal Airway Disease (AFAD)",207972,"Asthma","Asthma","Bronchial Diseases","Respiratory","Experimental|Placebo Comparator","Participants receiving GSK3772847|Participants receiving placebo","Participants will be randomized to receive GSK3772847 as IV infusion. Participants will receive three doses ( Day 1, Day 29 and Day 57) of GSK3772847 every 4 weeks|Participants will be randomized to receive matching placebo as IV infusion","Drug","GSK3772847|Placebo","GSK3772847 will be available as 100 mg/vial, white to yellow, uniform lyophilized cake in a 5 milliliter (mL) clear glass vial with closure sealed by red metal and yellow overseal.|Commercially sourced sterile normal saline will be provided as Placebo",null,"Participants receiving GSK3772847|Participants receiving placebo","\n\n * Participant must be at least 18 years of age inclusive, at the time of signing the informed consent.\n * Documented history of physician diagnosed moderate or severe asthma for >=12 months based on Guidelines and treated with inhaled corticosteroid (ICS) and long-acting beta-2-agonist (LABA) for at least 4 months (>=500 micrograms/day [Âµg/day]) fluticasone propionate or equivalent as defined in the guidelines.\n * Pre-bronchodilator FEV1 35-79% of predicted value for participant inclusive\n * FeNO >= 25 parts per billion (ppb) at Screening\n * ACQ-5 score >= 1.5 at Screening\n * Blood eosinophil >=300 cells/microliter at Screening\n * Evidence of allergic fungal airway disease like Fungal sensitization to any of the fungi Aspergillus fumigatus, Penicillium chrysogenum (notatum) at screening measured by serum-specific Immunoglobulin (Ig) E test. A history of exacerbations with at least 1 severe exacerbation (defined as requiring a minimum of 3 days of high-dose oral corticosteroids for asthma symptoms) in the previous 12 months.\n * Body weight within 50-150 kilogram (kg)\n * Both male and female gender. A female participant is eligible to participate if she is not pregnant not breastfeeding, Not a woman of childbearing potential (WOCBP) or A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 16 weeks after the last dose of study treatment.\n * Capable of giving signed informed consent\n\n","\n\n * Historical diagnosis of cystic fibrosis\n * Concurrent respiratory diseases: Presence of a known pre-existing, clinically important respiratory conditions (example pneumonia, pneumothorax, atelectasis segmental or larger, pulmonary fibrotic disease, bronchopulmonary dysplasia, chronic bronchitis, emphysema, chronic obstructive pulmonary disease, or other respiratory abnormalities) other than asthma or AFAD\n * Has a history of chronic or recurrent non-pulmonary infectious disease or ongoing non-pulmonary infection including, but not limited to, chronic renal infection, chronic chest infection, recurrent urinary tract infection (example, recurrent pyelonephritis, chronic non-remitting cystitis), or open, draining skin wound or an ulcer\n * Serious infection within 8 weeks of enrolment, including, but not limited to hepatitis, pneumonia, sepsis, or pyelonephritis; or has been hospitalized for an infection; or has been treated with IV antibiotics for an infection, within 8 weeks prior to the first administration of study drug.\n * Evidence of poorly controlled chronic medical conditions other than asthma, example, participants with known, pre-existing, clinically significant endocrine, autoimmune, metabolic, neurological, renal, cardiovascular, gastrointestinal, hepatic, and hematological or any other system abnormalities that are uncontrolled with standard treatment.\n * Cardiovascular disease: Clinically significant organic heart disease\n * Participants with a diagnosis of malignancy or in the process of investigation for a malignancy. Participants with carcinoma that have not been in complete remission for at least 5 years. Participants who have had carcinoma in situ of the cervix, squamous cell carcinoma and basal cell carcinoma of the skin would not be excluded based on the 5 year waiting period if the participant has been considered cured by treatment.\n * Eosinophilic diseases: Other conditions that could lead to elevated eosinophil such as hyper-eosinophilic syndromes. Participants with a known, pre-existing parasitic infestation within 6 months prior to Screening (Visit 1)\n * Prohibited medications is not permitted within the defined time intervals prior to Screening (Visit 1) and throughout the study.\n * Presence of hepatitis B surface antigen (HBsAg), positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study treatment.\n * A known immunodeficiency such as human immunodeficiency virus infection.\n * Hypersensitivity: significant allergies to humanized monoclonal antibodies or biologic or to any components of the formulation used in this study\n * Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear Ig A dermatosis, toxic epidermal necrolysis, and exfoliative dermatitis).\n * Clinically significant abnormality on 12-lead ECG assessment at screening (Visit 1). Site investigators will be provided with ECG over-read conducted by a centralized independent cardiologist, to assist in evaluation of participant eligibility.\n * Sinus bradycardia <45 beats per minute (bpm), sinus tachycardia >= 110 bpm, multifocal atrial tachycardia (wandering atrial pacemaker with rate >100bpm), evidence of Mobitz II second degree or third degree atrioventricular (AV) block, pathological Q waves (defined as wide [>0.04 seconds] and deep [>0.4 millivolts (mV) (4 millimeter [mm] with 10mm/mV setting)] or >25% of the height of the corresponding R wave, providing the R wave was >0.5mV [5mm with 10mm/mV setting], appearing in at least two contiguous leads, evidence of ventricular ectopic couplets, bigeminy, trigeminy or multifocal premature ventricular complexes, for participants without complete right bundle branch block: QTc for heart rate by Fridericia's formula QTc(F) >= 450 millisecond (msec) or an ECG that is unsuitable for QT measurements, for participants with complete right bundle branch block: QTc(F) >=480 msec or an ECG that is unsuitable for QT measurements, ST-T wave abnormalities, clinically significant conduction abnormalities and clinically significant arrhythmias.\n * Smoking history: current smokers or former smokers with a smoking history >= 10 pack years\n * History of alcohol or illegal substance abuse within 2 years prior to Screening (Visit1).\n * Participants at risk of non-compliance, or unable to comply with the study procedures. Participants who are unable to follow study instructions such as visit schedule and paper diary completion. Participants who have known evidence of lack of adherence to controller medication and/or ability to follow physician's recommendations. Any infirmity, disability, or geographic location that would limit compliance for scheduled visits.",{"$nulls":4},"Actual","2018-01-09","Actual","Anticipated","2019-10-10","Anticipated","2018-10-01","2018-01-03","2018-01-03","2018-10-02","No","Asthma Control Questionnaire\nAllergic fungal airway disease\nAsthma Quality of Life Questionnaire\nHolter monitoring\nAsthma","Interventional","Treatment","Parallel Assignment","Double (Participant, Investigator)","Randomized","18 Years",null,"All",null,"No","Yes\nIPD for this study will be made available via the Clinical Study Data Request site.",{"$nulls":3},"No","No",{"$nulls":19},"Change from Baseline in blood eosinophils|Change from Baseline in fractional exhaled nitric oxide (FeNO)","Blood samples will be collected at indicated time points for the assessment of eosinophil|FeNO will be measured using a handheld electronic device","Baseline and up to Day 88","Serum concentrations of GSK3772847|Serum levels of free soluble suppressor of tumorigenicity 2 (ST2)|Serum levels of total soluble ST2|Number of participants with positive result of serum anti-GSK3772847 antibodies post dosing|Titers of serum anti-GSK3772847 antibodies post dosing|Change from Baseline in Asthma Control Questionnaire-5 (ACQ-5) absolute score at Weeks 2, 4, 8 and 12|Change from Baseline in Asthma Quality of Life Questionnaire (AQLQ) total and domain scores at Weeks 2, 4, 8 and 12|Number of responders to ACQ-5|Number of responders to AQLQ|Change from Baseline in forced expiratory volume in 1 second (FEV1)|Change from Baseline in forced vital capacity (FVC)|Number of participants with treatment emergent adverse events (AE) and serious AEs (SAE)|Number of participants with abnormal hematology parameters|Number of participants with abnormal clinical chemistry parameters|Number of participants with abnormal systolic blood pressure (SBP) and diastolic blood pressure (DBP)|Number of participants with abnormal heart rate|Number of participants with abnormal findings in Electrocardiogram (ECG)|Number of participants with abnormal 24-hour Holter findings","Blood samples will be collected at indicated time points for assessment of serum concentrations|Blood samples will be collected at indicated time points to measure free soluble ST2|Blood samples will be collected at indicated time points to measure total soluble ST2|Blood samples will be collected at indicated time points and anti-GSK3772847 antibodies will be assessed using a tiered approach.|ACQ-5 is a 5-item questionnaire that is a measure of the participant's asthma control. The five questions include about the frequency and/or severity of symptoms like nocturnal awakening, activity limitation, shortness of breath and wheeze. The score scales from zero (totally controlled) and 6 (severely uncontrolled)|AQLQ is 32 items four domains questionnaire used for evaluation of impact of asthma treatments on the quality of life of participants. The scores are evaluated from 1 (total impairment) and 7 (no impairment)|ACQ-5 is a 5 question tool used to measure attributes of asthma control and the score ranges from 0 to 6 where 0 is no impairment/limitation and 6 is total impairment/limitation. A responder to ACQ-5 will be defined as a participant who has a decrease from Baseline in ACQ-5 score of 0.5 or more.|AQLQ is a 32 items four domain questionnaire used to measure quality of life participants due to asthma treatment and the scores ranges from 1 to 7 where 1 indicates total impairment and 7 indicates no impairment. A responder to AQLQ will be defined as a participant who has an increase from Baseline in AQLQ score of 0.5 or more.|Spirometry assessment will include pre-bronchodilator FEV1|Spirometry assessment will include pre-bronchodilator FVC|An AE is any untoward medical occurrence in a clinical study participants, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that, at any dose may result in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment.|Laboratory assessment for hematology parameters will include Platelet count, hemoglobin, Red blood cell (RBC) count, hematocrit, Red blood cell distribution width (RDW), RBC indices like mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH) and mean corpuscular hemoglobin concentration (MCHC). White blood cell (WBC) count with differential will include neutrophils, lymphocytes, monocytes, eosinophils and basophils.|Laboratory assessment for clinical chemistry parameters will include blood urea nitrogen (BUN), potassium, calcium, sodium, creatinine, non-fasting glucose, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline phosphate, Gamma-glutamyl transferase (GGT), albumin, phosphorus, carbon dioxide, total protein, creatine phosphokinase (CPK), total and direct bilirubin|Blood pressure will be measured in supine position after 5 minutes rest|Heart rate will be measured in supine position after 5 minutes rest|Single 12-lead ECG will be obtained using an ECG machine that automatically measures heart rate, PR, QRS, QT, and QT interval corrected for heart rate (QTc) and ventricular rate|Holter assessment will be used for quantitative assessment of abnormal rhythm events. Holter monitor will be placed 30-60 minutes prior to dosing.","Day 1 post-end of infusion, Day 15, Pre-dose on Day 29, Pre-dose and post-dose on Day 57, Day 85 and Day 169|Day 1 Pre and post-dose; Day 15; Day 29 Post dose; Day 57 pre and post dose; Day 85, Day 169|Up to Day 172|Baseline and at Weeks 2, 4, 8 and 12|Up to Day 88|Day 1","GSKClinicalSupportHD@gsk.com","US GSK Clinical Trials Call Center","877-379-3718","Brest Cedex, France, 29609|Amsterdam, Netherlands, 1105 Az|Wythenshawe, Greater Manchester, United Kingdom, M23 9Lt|Leicester, Leicestershire, United Kingdom, Le3 9Qp|Birmingham, United Kingdom, B9 5Ss",null,"France|Netherlands|United Kingdom","Gsk Investigational Site|, Greater Manchester Gsk Investigational Site|, Leicestershire Gsk Investigational Site",{"$nulls":3},"GSK Clinical Trials","2018-10-02","2020-05-25T16:35:50.162","2020-05-26T17:10:42.972","NCT03393806"]
["5ecbf3e6307e3d1b1f8d9c7d","NCT03393806","2018-10-12","GlaxoSmithKline","GSK","Recruiting","Repeat Dose Study of GSK3772847 in Participants With Moderate to Severe Asthma With Allergic Fungal Airway Disease (AFAD)","Gsk-3772847",null,"Yes","['Gsk-3772847']","Unknown",null,"Phase 2",2,46,"Anticipated","2018-04-18","2019-07-18",{"$nulls":5},"This study is multicenter, double-blinded parallel group design, where participants with moderate to severe asthma with AFAD will be enrolled. Participants will receive three doses of 10 milligrams/kilogram (mg/kg) of GSK3772847 every 4 Weeks versus placebo along with standard of care. Participants will be randomized in 1:1 ratio to receive either 10 mg/kg GSK3772847 intravenously (IV) or matching placebo IV. Participants will receive study treatment on Week 0 (Day 1), Week 4 and Week 8. The total duration of the study will be 28 Weeks and approximately 46 participants will be randomized.",null,"A Double Blind (Sponsor Open) Placebo-controlled, Stratified, Parallel Group Study to Evaluate the Efficacy and Safety of Repeat Doses of GSK3772847 in Participants With Moderate to Severe Asthma With Allergic Fungal Airway Disease (AFAD)",207972,"Asthma","Asthma","Bronchial Diseases","Respiratory","Experimental|Placebo Comparator","Participants receiving GSK3772847|Participants receiving placebo","Participants will be randomized to receive GSK3772847 as IV infusion. Participants will receive three doses ( Day 1, Day 29 and Day 57) of GSK3772847 every 4 weeks|Participants will be randomized to receive matching placebo as IV infusion","Drug","GSK3772847|Placebo","GSK3772847 will be available as 100 mg/vial, white to yellow, uniform lyophilized cake in a 5 milliliter (mL) clear glass vial with closure sealed by red metal and yellow overseal.|Commercially sourced sterile normal saline will be provided as Placebo",null,"Participants receiving GSK3772847|Participants receiving placebo","\n\n * Participant must be at least 18 years of age inclusive, at the time of signing the informed consent.\n * Documented history of physician diagnosed moderate or severe asthma for >=12 months based on Guidelines and treated with inhaled corticosteroid (ICS) and long-acting beta-2-agonist (LABA) for at least 4 months (>=500 micrograms/day [Âµg/day]) fluticasone propionate or equivalent as defined in the guidelines.\n * Pre-bronchodilator FEV1 35-79% of predicted value for participant inclusive\n * FeNO >= 25 parts per billion (ppb) at Screening\n * ACQ-5 score >= 1.5 at Screening\n * Blood eosinophil >=300 cells/microliter at Screening\n * Evidence of allergic fungal airway disease like Fungal sensitization to any of the fungi Aspergillus fumigatus, Penicillium chrysogenum (notatum) at screening measured by serum-specific Immunoglobulin (Ig) E test. A history of exacerbations with at least 1 severe exacerbation (defined as requiring a minimum of 3 days of high-dose oral corticosteroids for asthma symptoms) in the previous 12 months.\n * Body weight within 50-150 kilogram (kg)\n * Both male and female gender. A female participant is eligible to participate if she is not pregnant not breastfeeding, Not a woman of childbearing potential (WOCBP) or A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 16 weeks after the last dose of study treatment.\n * Capable of giving signed informed consent\n\n","\n\n * Historical diagnosis of cystic fibrosis\n * Concurrent respiratory diseases: Presence of a known pre-existing, clinically important respiratory conditions (example pneumonia, pneumothorax, atelectasis segmental or larger, pulmonary fibrotic disease, bronchopulmonary dysplasia, chronic bronchitis, emphysema, chronic obstructive pulmonary disease, or other respiratory abnormalities) other than asthma or AFAD\n * Has a history of chronic or recurrent non-pulmonary infectious disease or ongoing non-pulmonary infection including, but not limited to, chronic renal infection, chronic chest infection, recurrent urinary tract infection (example, recurrent pyelonephritis, chronic non-remitting cystitis), or open, draining skin wound or an ulcer\n * Serious infection within 8 weeks of enrolment, including, but not limited to hepatitis, pneumonia, sepsis, or pyelonephritis; or has been hospitalized for an infection; or has been treated with IV antibiotics for an infection, within 8 weeks prior to the first administration of study drug.\n * Evidence of poorly controlled chronic medical conditions other than asthma, example, participants with known, pre-existing, clinically significant endocrine, autoimmune, metabolic, neurological, renal, cardiovascular, gastrointestinal, hepatic, and hematological or any other system abnormalities that are uncontrolled with standard treatment.\n * Cardiovascular disease: Clinically significant organic heart disease\n * Participants with a diagnosis of malignancy or in the process of investigation for a malignancy. Participants with carcinoma that have not been in complete remission for at least 5 years. Participants who have had carcinoma in situ of the cervix, squamous cell carcinoma and basal cell carcinoma of the skin would not be excluded based on the 5 year waiting period if the participant has been considered cured by treatment.\n * Eosinophilic diseases: Other conditions that could lead to elevated eosinophil such as hyper-eosinophilic syndromes. Participants with a known, pre-existing parasitic infestation within 6 months prior to Screening (Visit 1)\n * Prohibited medications is not permitted within the defined time intervals prior to Screening (Visit 1) and throughout the study.\n * Presence of hepatitis B surface antigen (HBsAg), positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study treatment.\n * A known immunodeficiency such as human immunodeficiency virus infection.\n * Hypersensitivity: significant allergies to humanized monoclonal antibodies or biologic or to any components of the formulation used in this study\n * Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear Ig A dermatosis, toxic epidermal necrolysis, and exfoliative dermatitis).\n * Clinically significant abnormality on 12-lead ECG assessment at screening (Visit 1). Site investigators will be provided with ECG over-read conducted by a centralized independent cardiologist, to assist in evaluation of participant eligibility.\n * Sinus bradycardia <45 beats per minute (bpm), sinus tachycardia >= 110 bpm, multifocal atrial tachycardia (wandering atrial pacemaker with rate >100bpm), evidence of Mobitz II second degree or third degree atrioventricular (AV) block, pathological Q waves (defined as wide [>0.04 seconds] and deep [>0.4 millivolts (mV) (4 millimeter [mm] with 10mm/mV setting)] or >25% of the height of the corresponding R wave, providing the R wave was >0.5mV [5mm with 10mm/mV setting], appearing in at least two contiguous leads, evidence of ventricular ectopic couplets, bigeminy, trigeminy or multifocal premature ventricular complexes, for participants without complete right bundle branch block: QTc for heart rate by Fridericia's formula QTc(F) >= 450 millisecond (msec) or an ECG that is unsuitable for QT measurements, for participants with complete right bundle branch block: QTc(F) >=480 msec or an ECG that is unsuitable for QT measurements, ST-T wave abnormalities, clinically significant conduction abnormalities and clinically significant arrhythmias.\n * Smoking history: current smokers or former smokers with a smoking history >= 10 pack years\n * History of alcohol or illegal substance abuse within 2 years prior to Screening (Visit1).\n * Participants at risk of non-compliance, or unable to comply with the study procedures. Participants who are unable to follow study instructions such as visit schedule and paper diary completion. Participants who have known evidence of lack of adherence to controller medication and/or ability to follow physician's recommendations. Any infirmity, disability, or geographic location that would limit compliance for scheduled visits.",{"$nulls":4},"Actual","2018-01-09","Actual","Anticipated","2019-10-10","Anticipated","2018-10-01","2018-01-03","2018-01-03","2018-10-11","No","Asthma Control Questionnaire\nAllergic fungal airway disease\nAsthma Quality of Life Questionnaire\nHolter monitoring\nAsthma","Interventional","Treatment","Parallel Assignment","Double (Participant, Investigator)","Randomized","18 Years",null,"All",null,"No","Yes\nIPD for this study will be made available via the Clinical Study Data Request site.",{"$nulls":3},"No","No",{"$nulls":19},"Change from Baseline in blood eosinophils|Change from Baseline in fractional exhaled nitric oxide (FeNO)","Blood samples will be collected at indicated time points for the assessment of eosinophil|FeNO will be measured using a handheld electronic device","Baseline and up to Day 88","Serum concentrations of GSK3772847|Serum levels of free soluble suppressor of tumorigenicity 2 (ST2)|Serum levels of total soluble ST2|Number of participants with positive result of serum anti-GSK3772847 antibodies post dosing|Titers of serum anti-GSK3772847 antibodies post dosing|Change from Baseline in Asthma Control Questionnaire-5 (ACQ-5) absolute score at Weeks 2, 4, 8 and 12|Change from Baseline in Asthma Quality of Life Questionnaire (AQLQ) total and domain scores at Weeks 2, 4, 8 and 12|Number of responders to ACQ-5|Number of responders to AQLQ|Change from Baseline in forced expiratory volume in 1 second (FEV1)|Change from Baseline in forced vital capacity (FVC)|Number of participants with treatment emergent adverse events (AE) and serious AEs (SAE)|Number of participants with abnormal hematology parameters|Number of participants with abnormal clinical chemistry parameters|Number of participants with abnormal systolic blood pressure (SBP) and diastolic blood pressure (DBP)|Number of participants with abnormal heart rate|Number of participants with abnormal findings in Electrocardiogram (ECG)|Number of participants with abnormal 24-hour Holter findings","Blood samples will be collected at indicated time points for assessment of serum concentrations|Blood samples will be collected at indicated time points to measure free soluble ST2|Blood samples will be collected at indicated time points to measure total soluble ST2|Blood samples will be collected at indicated time points and anti-GSK3772847 antibodies will be assessed using a tiered approach.|ACQ-5 is a 5-item questionnaire that is a measure of the participant's asthma control. The five questions include about the frequency and/or severity of symptoms like nocturnal awakening, activity limitation, shortness of breath and wheeze. The score scales from zero (totally controlled) and 6 (severely uncontrolled)|AQLQ is 32 items four domains questionnaire used for evaluation of impact of asthma treatments on the quality of life of participants. The scores are evaluated from 1 (total impairment) and 7 (no impairment)|ACQ-5 is a 5 question tool used to measure attributes of asthma control and the score ranges from 0 to 6 where 0 is no impairment/limitation and 6 is total impairment/limitation. A responder to ACQ-5 will be defined as a participant who has a decrease from Baseline in ACQ-5 score of 0.5 or more.|AQLQ is a 32 items four domain questionnaire used to measure quality of life participants due to asthma treatment and the scores ranges from 1 to 7 where 1 indicates total impairment and 7 indicates no impairment. A responder to AQLQ will be defined as a participant who has an increase from Baseline in AQLQ score of 0.5 or more.|Spirometry assessment will include pre-bronchodilator FEV1|Spirometry assessment will include pre-bronchodilator FVC|An AE is any untoward medical occurrence in a clinical study participants, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that, at any dose may result in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment.|Laboratory assessment for hematology parameters will include Platelet count, hemoglobin, Red blood cell (RBC) count, hematocrit, Red blood cell distribution width (RDW), RBC indices like mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH) and mean corpuscular hemoglobin concentration (MCHC). White blood cell (WBC) count with differential will include neutrophils, lymphocytes, monocytes, eosinophils and basophils.|Laboratory assessment for clinical chemistry parameters will include blood urea nitrogen (BUN), potassium, calcium, sodium, creatinine, non-fasting glucose, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline phosphate, Gamma-glutamyl transferase (GGT), albumin, phosphorus, carbon dioxide, total protein, creatine phosphokinase (CPK), total and direct bilirubin|Blood pressure will be measured in supine position after 5 minutes rest|Heart rate will be measured in supine position after 5 minutes rest|Single 12-lead ECG will be obtained using an ECG machine that automatically measures heart rate, PR, QRS, QT, and QT interval corrected for heart rate (QTc) and ventricular rate|Holter assessment will be used for quantitative assessment of abnormal rhythm events. Holter monitor will be placed 30-60 minutes prior to dosing.","Day 1 post-end of infusion, Day 15, Pre-dose on Day 29, Pre-dose and post-dose on Day 57, Day 85 and Day 169|Day 1 Pre and post-dose; Day 15; Day 29 Post dose; Day 57 pre and post dose; Day 85, Day 169|Up to Day 172|Baseline and at Weeks 2, 4, 8 and 12|Up to Day 88|Day 1","GSKClinicalSupportHD@gsk.com","US GSK Clinical Trials Call Center","877-379-3718","Brest Cedex, France, 29609|Amsterdam, Netherlands, 1105 Az|Wythenshawe, Greater Manchester, United Kingdom, M23 9Lt|Leicester, Leicestershire, United Kingdom, Le3 9Qp|Liverpool, Merseyside, United Kingdom, L7 8Xp|Birmingham, United Kingdom, B9 5Ss",null,"France|Netherlands|United Kingdom","Gsk Investigational Site|, Greater Manchester Gsk Investigational Site|, Leicestershire Gsk Investigational Site|, Merseyside Gsk Investigational Site",{"$nulls":3},"GSK Clinical Trials","2018-10-11","2020-05-25T16:35:50.180","2020-05-26T17:10:42.972","NCT03393806"]
["5ecbf3e6feab101b1553081d","NCT03393806","2019-06-13","GlaxoSmithKline","GSK","Recruiting","Repeat Dose Study of GSK3772847 in Participants With Moderate to Severe Asthma With Allergic Fungal Airway Disease (AFAD)","Gsk-3772847",null,"Yes","['Gsk-3772847']","Unknown",null,"Phase 2",2,46,"Anticipated","2018-04-18","2019-10-17",{"$nulls":5},"This study is multicenter, double-blinded parallel group design, where participants with moderate to severe asthma with AFAD will be enrolled. Participants will receive three doses of 10 milligrams/kilogram (mg/kg) of GSK3772847 every 4 Weeks versus placebo along with standard of care. Participants will be randomized in 1:1 ratio to receive either 10 mg/kg GSK3772847 intravenously (IV) or matching placebo IV. Participants will receive study treatment on Week 0 (Day 1), Week 4 and Week 8. The total duration of the study will be 28 Weeks and approximately 46 participants will be randomized.",null,"A Double Blind (Sponsor Open) Placebo-controlled, Stratified, Parallel Group Study to Evaluate the Efficacy and Safety of Repeat Doses of GSK3772847 in Participants With Moderate to Severe Asthma With Allergic Fungal Airway Disease (AFAD)",207972,"Asthma","Asthma","Bronchial Diseases","Respiratory","Experimental|Placebo Comparator","Participants receiving GSK3772847|Participants receiving placebo","Participants will be randomized to receive GSK3772847 as IV infusion. Participants will receive three doses ( Day 1, Day 29 and Day 57) of GSK3772847 every 4 weeks|Participants will be randomized to receive matching placebo as IV infusion","Drug","GSK3772847|Placebo","GSK3772847 will be available as 100 mg/vial, white to yellow, uniform lyophilized cake in a 5 milliliter (mL) clear glass vial with closure sealed by red metal and yellow overseal.|Commercially sourced sterile normal saline will be provided as Placebo",null,"Participants receiving GSK3772847|Participants receiving placebo","\n\n * Participant must be at least 18 years of age inclusive, at the time of signing the informed consent.\n * Documented history of physician diagnosed moderate or severe asthma for >=12 months based on Guidelines and treated with inhaled corticosteroid (ICS) and long-acting beta-2-agonist (LABA) for at least 4 months (>=500 micrograms/day [Âµg/day]) fluticasone propionate or equivalent as defined in the guidelines.\n * Pre-bronchodilator FEV1 35-79% of predicted value for participant inclusive\n * FeNO >= 25 parts per billion (ppb) at Screening\n * ACQ-5 score >= 1.5 at Screening\n * Blood eosinophil >=300 cells/microliter at Screening\n * Evidence of allergic fungal airway disease like Fungal sensitization to any of the fungi Aspergillus fumigatus, Penicillium chrysogenum (notatum) at screening measured by serum-specific Immunoglobulin (Ig) E test. A history of exacerbations with at least 1 severe exacerbation (defined as requiring a minimum of 3 days of high-dose oral corticosteroids for asthma symptoms) in the previous 12 months.\n * Body weight within 50-150 kilogram (kg)\n * Both male and female gender. A female participant is eligible to participate if she is not pregnant not breastfeeding, Not a woman of childbearing potential (WOCBP) or A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 16 weeks after the last dose of study treatment.\n * Capable of giving signed informed consent\n\n","\n\n * Historical diagnosis of cystic fibrosis\n * Concurrent respiratory diseases: Presence of a known pre-existing, clinically important respiratory conditions (example pneumonia, pneumothorax, atelectasis segmental or larger, pulmonary fibrotic disease, bronchopulmonary dysplasia, chronic bronchitis, emphysema, chronic obstructive pulmonary disease, or other respiratory abnormalities) other than asthma or AFAD\n * Has a history of chronic or recurrent non-pulmonary infectious disease or ongoing non-pulmonary infection including, but not limited to, chronic renal infection, chronic chest infection, recurrent urinary tract infection (example, recurrent pyelonephritis, chronic non-remitting cystitis), or open, draining skin wound or an ulcer\n * Serious infection within 8 weeks of enrolment, including, but not limited to hepatitis, pneumonia, sepsis, or pyelonephritis; or has been hospitalized for an infection; or has been treated with IV antibiotics for an infection, within 8 weeks prior to the first administration of study drug.\n * Evidence of poorly controlled chronic medical conditions other than asthma, example, participants with known, pre-existing, clinically significant endocrine, autoimmune, metabolic, neurological, renal, cardiovascular, gastrointestinal, hepatic, and hematological or any other system abnormalities that are uncontrolled with standard treatment.\n * Cardiovascular disease: Clinically significant organic heart disease\n * Participants with a diagnosis of malignancy or in the process of investigation for a malignancy. Participants with carcinoma that have not been in complete remission for at least 5 years. Participants who have had carcinoma in situ of the cervix, squamous cell carcinoma and basal cell carcinoma of the skin would not be excluded based on the 5 year waiting period if the participant has been considered cured by treatment.\n * Eosinophilic diseases: Other conditions that could lead to elevated eosinophil such as hyper-eosinophilic syndromes. Participants with a known, pre-existing parasitic infestation within 6 months prior to Screening (Visit 1)\n * Prohibited medications is not permitted within the defined time intervals prior to Screening (Visit 1) and throughout the study.\n * Presence of hepatitis B surface antigen (HBsAg), positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study treatment.\n * A known immunodeficiency such as human immunodeficiency virus infection.\n * Hypersensitivity: significant allergies to humanized monoclonal antibodies or biologic or to any components of the formulation used in this study\n * Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear Ig A dermatosis, toxic epidermal necrolysis, and exfoliative dermatitis).\n * Clinically significant abnormality on 12-lead ECG assessment at screening (Visit 1). Site investigators will be provided with ECG over-read conducted by a centralized independent cardiologist, to assist in evaluation of participant eligibility.\n * Sinus bradycardia <45 beats per minute (bpm), sinus tachycardia >= 110 bpm, multifocal atrial tachycardia (wandering atrial pacemaker with rate >100bpm), evidence of Mobitz II second degree or third degree atrioventricular (AV) block, pathological Q waves (defined as wide [>0.04 seconds] and deep [>0.4 millivolts (mV) (4 millimeter [mm] with 10mm/mV setting)] or >25% of the height of the corresponding R wave, providing the R wave was >0.5mV [5mm with 10mm/mV setting], appearing in at least two contiguous leads, evidence of ventricular ectopic couplets, bigeminy, trigeminy or multifocal premature ventricular complexes, for participants without complete right bundle branch block: QTc for heart rate by Fridericia's formula QTc(F) >= 450 millisecond (msec) or an ECG that is unsuitable for QT measurements, for participants with complete right bundle branch block: QTc(F) >=480 msec or an ECG that is unsuitable for QT measurements, ST-T wave abnormalities, clinically significant conduction abnormalities and clinically significant arrhythmias.\n * Smoking history: current smokers or former smokers with a smoking history >= 10 pack years\n * History of alcohol or illegal substance abuse within 2 years prior to Screening (Visit1).\n * Participants at risk of non-compliance, or unable to comply with the study procedures. Participants who are unable to follow study instructions such as visit schedule and paper diary completion. Participants who have known evidence of lack of adherence to controller medication and/or ability to follow physician's recommendations. Any infirmity, disability, or geographic location that would limit compliance for scheduled visits.",{"$nulls":4},"Actual","2018-01-09","Actual","Anticipated","2020-01-09","Anticipated","2019-06-01","2018-01-03","2018-01-03","2019-06-12","No","Asthma Control Questionnaire\nAllergic fungal airway disease\nAsthma Quality of Life Questionnaire\nHolter monitoring\nAsthma","Interventional","Treatment","Parallel Assignment","Double (Participant, Investigator)","Randomized","18 Years",null,"All",null,"No","Yes\nIPD for this study will be made available via the Clinical Study Data Request site.",{"$nulls":3},"No","No",{"$nulls":17},"2017-003544-20","EudraCT Number","Change from Baseline in blood eosinophils|Change from Baseline in fractional exhaled nitric oxide (FeNO)","Blood samples will be collected at indicated time points for the assessment of eosinophil|FeNO will be measured using a handheld electronic device","Baseline and up to Day 88","Serum concentrations of GSK3772847|Serum levels of free soluble suppressor of tumorigenicity 2 (ST2)|Serum levels of total soluble ST2|Number of participants with positive result of serum anti-GSK3772847 antibodies post dosing|Titers of serum anti-GSK3772847 antibodies post dosing|Change from Baseline in Asthma Control Questionnaire-5 (ACQ-5) absolute score at Weeks 2, 4, 8 and 12|Change from Baseline in Asthma Quality of Life Questionnaire (AQLQ) total and domain scores at Weeks 2, 4, 8 and 12|Number of responders to ACQ-5|Number of responders to AQLQ|Change from Baseline in forced expiratory volume in 1 second (FEV1)|Change from Baseline in forced vital capacity (FVC)|Number of participants with treatment emergent adverse events (AE) and serious AEs (SAE)|Number of participants with abnormal hematology parameters|Number of participants with abnormal clinical chemistry parameters|Number of participants with abnormal systolic blood pressure (SBP) and diastolic blood pressure (DBP)|Number of participants with abnormal heart rate|Number of participants with abnormal findings in Electrocardiogram (ECG)|Number of participants with abnormal 24-hour Holter findings","Blood samples will be collected at indicated time points for assessment of serum concentrations|Blood samples will be collected at indicated time points to measure free soluble ST2|Blood samples will be collected at indicated time points to measure total soluble ST2|Blood samples will be collected at indicated time points and anti-GSK3772847 antibodies will be assessed using a tiered approach.|ACQ-5 is a 5-item questionnaire that is a measure of the participant's asthma control. The five questions include about the frequency and/or severity of symptoms like nocturnal awakening, activity limitation, shortness of breath and wheeze. The score scales from zero (totally controlled) and 6 (severely uncontrolled)|AQLQ is 32 items four domains questionnaire used for evaluation of impact of asthma treatments on the quality of life of participants. The scores are evaluated from 1 (total impairment) and 7 (no impairment)|ACQ-5 is a 5 question tool used to measure attributes of asthma control and the score ranges from 0 to 6 where 0 is no impairment/limitation and 6 is total impairment/limitation. A responder to ACQ-5 will be defined as a participant who has a decrease from Baseline in ACQ-5 score of 0.5 or more.|AQLQ is a 32 items four domain questionnaire used to measure quality of life participants due to asthma treatment and the scores ranges from 1 to 7 where 1 indicates total impairment and 7 indicates no impairment. A responder to AQLQ will be defined as a participant who has an increase from Baseline in AQLQ score of 0.5 or more.|Spirometry assessment will include pre-bronchodilator FEV1|Spirometry assessment will include pre-bronchodilator FVC|An AE is any untoward medical occurrence in a clinical study participants, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that, at any dose may result in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment.|Laboratory assessment for hematology parameters will include Platelet count, hemoglobin, Red blood cell (RBC) count, hematocrit, Red blood cell distribution width (RDW), RBC indices like mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH) and mean corpuscular hemoglobin concentration (MCHC). White blood cell (WBC) count with differential will include neutrophils, lymphocytes, monocytes, eosinophils and basophils.|Laboratory assessment for clinical chemistry parameters will include blood urea nitrogen (BUN), potassium, calcium, sodium, creatinine, non-fasting glucose, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline phosphate, Gamma-glutamyl transferase (GGT), albumin, phosphorus, carbon dioxide, total protein, creatine phosphokinase (CPK), total and direct bilirubin|Blood pressure will be measured in supine position after 5 minutes rest|Heart rate will be measured in supine position after 5 minutes rest|Single 12-lead ECG will be obtained using an ECG machine that automatically measures heart rate, PR, QRS, QT, and QT interval corrected for heart rate (QTc) and ventricular rate|Holter assessment will be used for quantitative assessment of abnormal rhythm events. Holter monitor will be placed 30-60 minutes prior to dosing.","Day 1 post-end of infusion, Day 15, Pre-dose on Day 29, Pre-dose and post-dose on Day 57, Day 85 and Day 169|Day 1 Pre and post-dose; Day 15; Day 29 Post dose; Day 57 pre and post dose; Day 85, Day 169|Up to Day 172|Baseline and at Weeks 2, 4, 8 and 12|Up to Day 88|Day 1","GSKClinicalSupportHD@gsk.com","US GSK Clinical Trials Call Center","877-379-3718","Brest Cedex, France, 29609|Amsterdam, Netherlands, 1105 Az|Wythenshawe, Greater Manchester, United Kingdom, M23 9Lt|Leicester, Leicestershire, United Kingdom, Le3 9Qp|Liverpool, Merseyside, United Kingdom, L7 8Xp|Birmingham, United Kingdom, B9 5Ss",null,"France|Netherlands|United Kingdom","Gsk Investigational Site|, Greater Manchester Gsk Investigational Site|, Leicestershire Gsk Investigational Site|, Merseyside Gsk Investigational Site","GSKClinicalSupportHD@gsk.com","EU GSK Clinical Trials Call Center","+44 (0) 20 89904466","GSK Clinical Trials","2019-06-12","2020-05-25T16:35:50.238","2020-05-26T17:10:42.972","NCT03393806"]
["5ecbf3e6fe30261b1a0481ee","NCT03393806","2019-07-18","GlaxoSmithKline","GSK","Active, not recruiting","Repeat Dose Study of GSK3772847 in Participants With Moderate to Severe Asthma With Allergic Fungal Airway Disease (AFAD)","Gsk-3772847",null,"Yes","['Gsk-3772847']","Unknown",null,"Phase 2",2,46,"Anticipated","2018-04-18","2019-09-17",{"$nulls":5},"This study is multicenter, double-blinded parallel group design, where participants with moderate to severe asthma with AFAD will be enrolled. Participants will receive three doses of 10 milligrams/kilogram (mg/kg) of GSK3772847 every 4 Weeks versus placebo along with standard of care. Participants will be randomized in 1:1 ratio to receive either 10 mg/kg GSK3772847 intravenously (IV) or matching placebo IV. Participants will receive study treatment on Week 0 (Day 1), Week 4 and Week 8. The total duration of the study will be 28 Weeks and approximately 46 participants will be randomized.",null,"A Double Blind (Sponsor Open) Placebo-controlled, Stratified, Parallel Group Study to Evaluate the Efficacy and Safety of Repeat Doses of GSK3772847 in Participants With Moderate to Severe Asthma With Allergic Fungal Airway Disease (AFAD)",207972,"Asthma","Asthma","Bronchial Diseases","Respiratory","Experimental|Placebo Comparator","Participants receiving GSK3772847|Participants receiving placebo","Participants will be randomized to receive GSK3772847 as IV infusion. Participants will receive three doses ( Day 1, Day 29 and Day 57) of GSK3772847 every 4 weeks|Participants will be randomized to receive matching placebo as IV infusion","Drug","GSK3772847|Placebo","GSK3772847 will be available as 100 mg/vial, white to yellow, uniform lyophilized cake in a 5 milliliter (mL) clear glass vial with closure sealed by red metal and yellow overseal.|Commercially sourced sterile normal saline will be provided as Placebo",null,"Participants receiving GSK3772847|Participants receiving placebo","\n\n * Participant must be at least 18 years of age inclusive, at the time of signing the informed consent.\n * Documented history of physician diagnosed moderate or severe asthma for >=12 months based on Guidelines and treated with inhaled corticosteroid (ICS) and long-acting beta-2-agonist (LABA) for at least 4 months (>=500 micrograms/day [Âµg/day]) fluticasone propionate or equivalent as defined in the guidelines.\n * Pre-bronchodilator FEV1 35-79% of predicted value for participant inclusive\n * FeNO >= 25 parts per billion (ppb) at Screening\n * ACQ-5 score >= 1.5 at Screening\n * Blood eosinophil >=300 cells/microliter at Screening\n * Evidence of allergic fungal airway disease like Fungal sensitization to any of the fungi Aspergillus fumigatus, Penicillium chrysogenum (notatum) at screening measured by serum-specific Immunoglobulin (Ig) E test. A history of exacerbations with at least 1 severe exacerbation (defined as requiring a minimum of 3 days of high-dose oral corticosteroids for asthma symptoms) in the previous 12 months.\n * Body weight within 50-150 kilogram (kg)\n * Both male and female gender. A female participant is eligible to participate if she is not pregnant not breastfeeding, Not a woman of childbearing potential (WOCBP) or A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 16 weeks after the last dose of study treatment.\n * Capable of giving signed informed consent\n\n","\n\n * Historical diagnosis of cystic fibrosis\n * Concurrent respiratory diseases: Presence of a known pre-existing, clinically important respiratory conditions (example pneumonia, pneumothorax, atelectasis segmental or larger, pulmonary fibrotic disease, bronchopulmonary dysplasia, chronic bronchitis, emphysema, chronic obstructive pulmonary disease, or other respiratory abnormalities) other than asthma or AFAD\n * Has a history of chronic or recurrent non-pulmonary infectious disease or ongoing non-pulmonary infection including, but not limited to, chronic renal infection, chronic chest infection, recurrent urinary tract infection (example, recurrent pyelonephritis, chronic non-remitting cystitis), or open, draining skin wound or an ulcer\n * Serious infection within 8 weeks of enrolment, including, but not limited to hepatitis, pneumonia, sepsis, or pyelonephritis; or has been hospitalized for an infection; or has been treated with IV antibiotics for an infection, within 8 weeks prior to the first administration of study drug.\n * Evidence of poorly controlled chronic medical conditions other than asthma, example, participants with known, pre-existing, clinically significant endocrine, autoimmune, metabolic, neurological, renal, cardiovascular, gastrointestinal, hepatic, and hematological or any other system abnormalities that are uncontrolled with standard treatment.\n * Cardiovascular disease: Clinically significant organic heart disease\n * Participants with a diagnosis of malignancy or in the process of investigation for a malignancy. Participants with carcinoma that have not been in complete remission for at least 5 years. Participants who have had carcinoma in situ of the cervix, squamous cell carcinoma and basal cell carcinoma of the skin would not be excluded based on the 5 year waiting period if the participant has been considered cured by treatment.\n * Eosinophilic diseases: Other conditions that could lead to elevated eosinophil such as hyper-eosinophilic syndromes. Participants with a known, pre-existing parasitic infestation within 6 months prior to Screening (Visit 1)\n * Prohibited medications is not permitted within the defined time intervals prior to Screening (Visit 1) and throughout the study.\n * Presence of hepatitis B surface antigen (HBsAg), positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study treatment.\n * A known immunodeficiency such as human immunodeficiency virus infection.\n * Hypersensitivity: significant allergies to humanized monoclonal antibodies or biologic or to any components of the formulation used in this study\n * Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear Ig A dermatosis, toxic epidermal necrolysis, and exfoliative dermatitis).\n * Clinically significant abnormality on 12-lead ECG assessment at screening (Visit 1). Site investigators will be provided with ECG over-read conducted by a centralized independent cardiologist, to assist in evaluation of participant eligibility.\n * Sinus bradycardia <45 beats per minute (bpm), sinus tachycardia >= 110 bpm, multifocal atrial tachycardia (wandering atrial pacemaker with rate >100bpm), evidence of Mobitz II second degree or third degree atrioventricular (AV) block, pathological Q waves (defined as wide [>0.04 seconds] and deep [>0.4 millivolts (mV) (4 millimeter [mm] with 10mm/mV setting)] or >25% of the height of the corresponding R wave, providing the R wave was >0.5mV [5mm with 10mm/mV setting], appearing in at least two contiguous leads, evidence of ventricular ectopic couplets, bigeminy, trigeminy or multifocal premature ventricular complexes, for participants without complete right bundle branch block: QTc for heart rate by Fridericia's formula QTc(F) >= 450 millisecond (msec) or an ECG that is unsuitable for QT measurements, for participants with complete right bundle branch block: QTc(F) >=480 msec or an ECG that is unsuitable for QT measurements, ST-T wave abnormalities, clinically significant conduction abnormalities and clinically significant arrhythmias.\n * Smoking history: current smokers or former smokers with a smoking history >= 10 pack years\n * History of alcohol or illegal substance abuse within 2 years prior to Screening (Visit1).\n * Participants at risk of non-compliance, or unable to comply with the study procedures. Participants who are unable to follow study instructions such as visit schedule and paper diary completion. Participants who have known evidence of lack of adherence to controller medication and/or ability to follow physician's recommendations. Any infirmity, disability, or geographic location that would limit compliance for scheduled visits.",{"$nulls":4},"Actual","2018-01-09","Actual","Anticipated","2019-12-10","Anticipated","2019-07-01","2018-01-03","2018-01-03","2019-07-17","No","Asthma Control Questionnaire\nAllergic fungal airway disease\nAsthma Quality of Life Questionnaire\nHolter monitoring\nAsthma","Interventional","Treatment","Parallel Assignment","Double (Participant, Investigator)","Randomized","18 Years",null,"All",null,"No","Yes\nIPD for this study will be made available via the Clinical Study Data Request site.",{"$nulls":3},"No","No",{"$nulls":17},"2017-003544-20","EudraCT Number","Change from Baseline in blood eosinophils|Change from Baseline in fractional exhaled nitric oxide (FeNO)","Blood samples will be collected at indicated time points for the assessment of eosinophil|FeNO will be measured using a handheld electronic device","Baseline and up to Day 88","Serum concentrations of GSK3772847|Serum levels of free soluble suppressor of tumorigenicity 2 (ST2)|Serum levels of total soluble ST2|Number of participants with positive result of serum anti-GSK3772847 antibodies post dosing|Titers of serum anti-GSK3772847 antibodies post dosing|Change from Baseline in Asthma Control Questionnaire-5 (ACQ-5) absolute score at Weeks 2, 4, 8 and 12|Change from Baseline in Asthma Quality of Life Questionnaire (AQLQ) total and domain scores at Weeks 2, 4, 8 and 12|Number of responders to ACQ-5|Number of responders to AQLQ|Change from Baseline in forced expiratory volume in 1 second (FEV1)|Change from Baseline in forced vital capacity (FVC)|Number of participants with treatment emergent adverse events (AE) and serious AEs (SAE)|Number of participants with abnormal hematology parameters|Number of participants with abnormal clinical chemistry parameters|Number of participants with abnormal systolic blood pressure (SBP) and diastolic blood pressure (DBP)|Number of participants with abnormal heart rate|Number of participants with abnormal findings in Electrocardiogram (ECG)|Number of participants with abnormal 24-hour Holter findings","Blood samples will be collected at indicated time points for assessment of serum concentrations|Blood samples will be collected at indicated time points to measure free soluble ST2|Blood samples will be collected at indicated time points to measure total soluble ST2|Blood samples will be collected at indicated time points and anti-GSK3772847 antibodies will be assessed using a tiered approach.|ACQ-5 is a 5-item questionnaire that is a measure of the participant's asthma control. The five questions include about the frequency and/or severity of symptoms like nocturnal awakening, activity limitation, shortness of breath and wheeze. The score scales from zero (totally controlled) and 6 (severely uncontrolled)|AQLQ is 32 items four domains questionnaire used for evaluation of impact of asthma treatments on the quality of life of participants. The scores are evaluated from 1 (total impairment) and 7 (no impairment)|ACQ-5 is a 5 question tool used to measure attributes of asthma control and the score ranges from 0 to 6 where 0 is no impairment/limitation and 6 is total impairment/limitation. A responder to ACQ-5 will be defined as a participant who has a decrease from Baseline in ACQ-5 score of 0.5 or more.|AQLQ is a 32 items four domain questionnaire used to measure quality of life participants due to asthma treatment and the scores ranges from 1 to 7 where 1 indicates total impairment and 7 indicates no impairment. A responder to AQLQ will be defined as a participant who has an increase from Baseline in AQLQ score of 0.5 or more.|Spirometry assessment will include pre-bronchodilator FEV1|Spirometry assessment will include pre-bronchodilator FVC|An AE is any untoward medical occurrence in a clinical study participants, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that, at any dose may result in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment.|Laboratory assessment for hematology parameters will include Platelet count, hemoglobin, Red blood cell (RBC) count, hematocrit, Red blood cell distribution width (RDW), RBC indices like mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH) and mean corpuscular hemoglobin concentration (MCHC). White blood cell (WBC) count with differential will include neutrophils, lymphocytes, monocytes, eosinophils and basophils.|Laboratory assessment for clinical chemistry parameters will include blood urea nitrogen (BUN), potassium, calcium, sodium, creatinine, non-fasting glucose, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline phosphate, Gamma-glutamyl transferase (GGT), albumin, phosphorus, carbon dioxide, total protein, creatine phosphokinase (CPK), total and direct bilirubin|Blood pressure will be measured in supine position after 5 minutes rest|Heart rate will be measured in supine position after 5 minutes rest|Single 12-lead ECG will be obtained using an ECG machine that automatically measures heart rate, PR, QRS, QT, and QT interval corrected for heart rate (QTc) and ventricular rate|Holter assessment will be used for quantitative assessment of abnormal rhythm events. Holter monitor will be placed 30-60 minutes prior to dosing.","Day 1 post-end of infusion, Day 15, Pre-dose on Day 29, Pre-dose and post-dose on Day 57, Day 85 and Day 169|Day 1 Pre and post-dose; Day 15; Day 29 Post dose; Day 57 pre and post dose; Day 85, Day 169|Up to Day 172|Baseline and at Weeks 2, 4, 8 and 12|Up to Day 88|Day 1",{"$nulls":3},"Brest Cedex, France, 29609 Gsk Investigational SiteMarseille, France, 13015 Gsk Investigational SiteMontpellier Cedex 5, France, 34295 Gsk Investigational SiteNantes Cedex 1, France, 44093|Amsterdam, Netherlands, 1105 Az Russian Federation Gsk Investigational SiteIzhevsk, Russian Federation, 426063 Gsk Investigational SiteKemerovo, Russian Federation, 650000 Gsk Investigational SiteMoscow, Russian Federation, 105275 Gsk Investigational SiteMoscow, Russian Federation, 115478 Gsk Investigational SiteSaint Petersburg, Russian Federation, 194291 Gsk Investigational SiteSaint Petersburg, Russian Federation, 196240 Gsk Investigational SiteSaint-Petersburg, Russian Federation, 194354 Gsk Investigational SiteSaratov, Russian Federation, 410028 Gsk Investigational SiteUlyanovsk, Russian Federation, 432063|Wythenshawe, Greater Manchester, United Kingdom, M23 9Lt|Leicester, Leicestershire, United Kingdom, Le3 9Qp|Liverpool, Merseyside, United Kingdom, L7 8Xp|Birmingham, United Kingdom, B9 5Ss Gsk Investigational SiteBradford, United Kingdom, Bd9 6Rj Gsk Investigational SiteEdgbaston, United Kingdom, B15 2Gw",null,"France|Netherlands|United Kingdom","Gsk Investigational Site|, Greater Manchester Gsk Investigational Site|, Leicestershire Gsk Investigational Site|, Merseyside Gsk Investigational Site",{"$nulls":3},"GSK Clinical Trials","2019-07-17","2020-05-25T16:35:50.356","2020-05-26T17:10:42.972","NCT03393806"]
["5ecbf3e6fe30261b1a0481ed","NCT03393806","2019-09-25","GlaxoSmithKline","GSK","Active, not recruiting","Repeat Dose Study of GSK3772847 in Participants With Moderate to Severe Asthma With Allergic Fungal Airway Disease (AFAD)","Gsk-3772847",null,"Yes","['Gsk-3772847']","Unknown",null,"Phase 2",2,18,"Actual","2018-04-18","2019-10-08",{"$nulls":5},"This study is multicenter, double-blinded parallel group design, where participants with moderate to severe asthma with AFAD will be enrolled. Participants will receive three doses of 10 milligrams/kilogram (mg/kg) of GSK3772847 every 4 Weeks versus placebo along with standard of care. Participants will be randomized in 1:1 ratio to receive either 10 mg/kg GSK3772847 intravenously (IV) or matching placebo IV. Participants will receive study treatment on Week 0 (Day 1), Week 4 and Week 8. The total duration of the study will be 28 Weeks and approximately 46 participants will be randomized.",null,"A Double Blind (Sponsor Open) Placebo-controlled, Stratified, Parallel Group Study to Evaluate the Efficacy and Safety of Repeat Doses of GSK3772847 in Participants With Moderate to Severe Asthma With Allergic Fungal Airway Disease (AFAD)",207972,"Asthma","Asthma","Bronchial Diseases","Respiratory","Experimental|Placebo Comparator","Participants receiving GSK3772847|Participants receiving placebo","Participants will be randomized to receive GSK3772847 as IV infusion. Participants will receive three doses ( Day 1, Day 29 and Day 57) of GSK3772847 every 4 weeks|Participants will be randomized to receive matching placebo as IV infusion","Drug","GSK3772847|Placebo","GSK3772847 will be available as 100 mg/vial, white to yellow, uniform lyophilized cake in a 5 milliliter (mL) clear glass vial with closure sealed by red metal and yellow overseal.|Commercially sourced sterile normal saline will be provided as Placebo",null,"Participants receiving GSK3772847|Participants receiving placebo","\n\n * Participant must be at least 18 years of age inclusive, at the time of signing the informed consent.\n * Documented history of physician diagnosed moderate or severe asthma for >=12 months based on Guidelines and treated with inhaled corticosteroid (ICS) and long-acting beta-2-agonist (LABA) for at least 4 months (>=500 micrograms/day [Âµg/day]) fluticasone propionate or equivalent as defined in the guidelines.\n * Pre-bronchodilator FEV1 35-79% of predicted value for participant inclusive\n * FeNO >= 25 parts per billion (ppb) at Screening\n * ACQ-5 score >= 1.5 at Screening\n * Blood eosinophil >=300 cells/microliter at Screening\n * Evidence of allergic fungal airway disease like Fungal sensitization to any of the fungi Aspergillus fumigatus, Penicillium chrysogenum (notatum) at screening measured by serum-specific Immunoglobulin (Ig) E test. A history of exacerbations with at least 1 severe exacerbation (defined as requiring a minimum of 3 days of high-dose oral corticosteroids for asthma symptoms) in the previous 12 months.\n * Body weight within 50-150 kilogram (kg)\n * Both male and female gender. A female participant is eligible to participate if she is not pregnant not breastfeeding, Not a woman of childbearing potential (WOCBP) or A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 16 weeks after the last dose of study treatment.\n * Capable of giving signed informed consent\n\n","\n\n * Historical diagnosis of cystic fibrosis\n * Concurrent respiratory diseases: Presence of a known pre-existing, clinically important respiratory conditions (example pneumonia, pneumothorax, atelectasis segmental or larger, pulmonary fibrotic disease, bronchopulmonary dysplasia, chronic bronchitis, emphysema, chronic obstructive pulmonary disease, or other respiratory abnormalities) other than asthma or AFAD\n * Has a history of chronic or recurrent non-pulmonary infectious disease or ongoing non-pulmonary infection including, but not limited to, chronic renal infection, chronic chest infection, recurrent urinary tract infection (example, recurrent pyelonephritis, chronic non-remitting cystitis), or open, draining skin wound or an ulcer\n * Serious infection within 8 weeks of enrolment, including, but not limited to hepatitis, pneumonia, sepsis, or pyelonephritis; or has been hospitalized for an infection; or has been treated with IV antibiotics for an infection, within 8 weeks prior to the first administration of study drug.\n * Evidence of poorly controlled chronic medical conditions other than asthma, example, participants with known, pre-existing, clinically significant endocrine, autoimmune, metabolic, neurological, renal, cardiovascular, gastrointestinal, hepatic, and hematological or any other system abnormalities that are uncontrolled with standard treatment.\n * Cardiovascular disease: Clinically significant organic heart disease\n * Participants with a diagnosis of malignancy or in the process of investigation for a malignancy. Participants with carcinoma that have not been in complete remission for at least 5 years. Participants who have had carcinoma in situ of the cervix, squamous cell carcinoma and basal cell carcinoma of the skin would not be excluded based on the 5 year waiting period if the participant has been considered cured by treatment.\n * Eosinophilic diseases: Other conditions that could lead to elevated eosinophil such as hyper-eosinophilic syndromes. Participants with a known, pre-existing parasitic infestation within 6 months prior to Screening (Visit 1)\n * Prohibited medications is not permitted within the defined time intervals prior to Screening (Visit 1) and throughout the study.\n * Presence of hepatitis B surface antigen (HBsAg), positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study treatment.\n * A known immunodeficiency such as human immunodeficiency virus infection.\n * Hypersensitivity: significant allergies to humanized monoclonal antibodies or biologic or to any components of the formulation used in this study\n * Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear Ig A dermatosis, toxic epidermal necrolysis, and exfoliative dermatitis).\n * Clinically significant abnormality on 12-lead ECG assessment at screening (Visit 1). Site investigators will be provided with ECG over-read conducted by a centralized independent cardiologist, to assist in evaluation of participant eligibility.\n * Sinus bradycardia <45 beats per minute (bpm), sinus tachycardia >= 110 bpm, multifocal atrial tachycardia (wandering atrial pacemaker with rate >100bpm), evidence of Mobitz II second degree or third degree atrioventricular (AV) block, pathological Q waves (defined as wide [>0.04 seconds] and deep [>0.4 millivolts (mV) (4 millimeter [mm] with 10mm/mV setting)] or >25% of the height of the corresponding R wave, providing the R wave was >0.5mV [5mm with 10mm/mV setting], appearing in at least two contiguous leads, evidence of ventricular ectopic couplets, bigeminy, trigeminy or multifocal premature ventricular complexes, for participants without complete right bundle branch block: QTc for heart rate by Fridericia's formula QTc(F) >= 450 millisecond (msec) or an ECG that is unsuitable for QT measurements, for participants with complete right bundle branch block: QTc(F) >=480 msec or an ECG that is unsuitable for QT measurements, ST-T wave abnormalities, clinically significant conduction abnormalities and clinically significant arrhythmias.\n * Smoking history: current smokers or former smokers with a smoking history >= 10 pack years\n * History of alcohol or illegal substance abuse within 2 years prior to Screening (Visit1).\n * Participants at risk of non-compliance, or unable to comply with the study procedures. Participants who are unable to follow study instructions such as visit schedule and paper diary completion. Participants who have known evidence of lack of adherence to controller medication and/or ability to follow physician's recommendations. Any infirmity, disability, or geographic location that would limit compliance for scheduled visits.",{"$nulls":4},"Actual","2018-01-09","Actual","Anticipated","2019-12-31","Anticipated","2019-09-01","2018-01-03","2018-01-03","2019-09-24","No","Asthma Control Questionnaire\nAllergic fungal airway disease\nAsthma Quality of Life Questionnaire\nHolter monitoring\nAsthma","Interventional","Treatment","Parallel Assignment","Double (Participant, Investigator)","Randomized","18 Years",null,"All",null,"No","Yes\nIPD for this study will be made available via the Clinical Study Data Request site.",{"$nulls":3},"No","No",{"$nulls":17},"2017-003544-20","EudraCT Number","Change from Baseline in blood eosinophils|Change from Baseline in fractional exhaled nitric oxide (FeNO)","Blood samples will be collected at indicated time points for the assessment of eosinophil|FeNO will be measured using a handheld electronic device","Baseline and up to Day 88","Serum concentrations of GSK3772847|Serum levels of free soluble suppressor of tumorigenicity 2 (ST2)|Serum levels of total soluble ST2|Number of participants with positive result of serum anti-GSK3772847 antibodies post dosing|Titers of serum anti-GSK3772847 antibodies post dosing|Change from Baseline in Asthma Control Questionnaire-5 (ACQ-5) absolute score at Weeks 2, 4, 8 and 12|Change from Baseline in Asthma Quality of Life Questionnaire (AQLQ) total and domain scores at Weeks 2, 4, 8 and 12|Number of responders to ACQ-5|Number of responders to AQLQ|Change from Baseline in forced expiratory volume in 1 second (FEV1)|Change from Baseline in forced vital capacity (FVC)|Number of participants with treatment emergent adverse events (AE) and serious AEs (SAE)|Number of participants with abnormal hematology parameters|Number of participants with abnormal clinical chemistry parameters|Number of participants with abnormal systolic blood pressure (SBP) and diastolic blood pressure (DBP)|Number of participants with abnormal heart rate|Number of participants with abnormal findings in Electrocardiogram (ECG)|Number of participants with abnormal 24-hour Holter findings","Blood samples will be collected at indicated time points for assessment of serum concentrations|Blood samples will be collected at indicated time points to measure free soluble ST2|Blood samples will be collected at indicated time points to measure total soluble ST2|Blood samples will be collected at indicated time points and anti-GSK3772847 antibodies will be assessed using a tiered approach.|ACQ-5 is a 5-item questionnaire that is a measure of the participant's asthma control. The five questions include about the frequency and/or severity of symptoms like nocturnal awakening, activity limitation, shortness of breath and wheeze. The score scales from zero (totally controlled) and 6 (severely uncontrolled)|AQLQ is 32 items four domains questionnaire used for evaluation of impact of asthma treatments on the quality of life of participants. The scores are evaluated from 1 (total impairment) and 7 (no impairment)|ACQ-5 is a 5 question tool used to measure attributes of asthma control and the score ranges from 0 to 6 where 0 is no impairment/limitation and 6 is total impairment/limitation. A responder to ACQ-5 will be defined as a participant who has a decrease from Baseline in ACQ-5 score of 0.5 or more.|AQLQ is a 32 items four domain questionnaire used to measure quality of life participants due to asthma treatment and the scores ranges from 1 to 7 where 1 indicates total impairment and 7 indicates no impairment. A responder to AQLQ will be defined as a participant who has an increase from Baseline in AQLQ score of 0.5 or more.|Spirometry assessment will include pre-bronchodilator FEV1|Spirometry assessment will include pre-bronchodilator FVC|An AE is any untoward medical occurrence in a clinical study participants, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that, at any dose may result in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment.|Laboratory assessment for hematology parameters will include Platelet count, hemoglobin, Red blood cell (RBC) count, hematocrit, Red blood cell distribution width (RDW), RBC indices like mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH) and mean corpuscular hemoglobin concentration (MCHC). White blood cell (WBC) count with differential will include neutrophils, lymphocytes, monocytes, eosinophils and basophils.|Laboratory assessment for clinical chemistry parameters will include blood urea nitrogen (BUN), potassium, calcium, sodium, creatinine, non-fasting glucose, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline phosphate, Gamma-glutamyl transferase (GGT), albumin, phosphorus, carbon dioxide, total protein, creatine phosphokinase (CPK), total and direct bilirubin|Blood pressure will be measured in supine position after 5 minutes rest|Heart rate will be measured in supine position after 5 minutes rest|Single 12-lead ECG will be obtained using an ECG machine that automatically measures heart rate, PR, QRS, QT, and QT interval corrected for heart rate (QTc) and ventricular rate|Holter assessment will be used for quantitative assessment of abnormal rhythm events. Holter monitor will be placed 30-60 minutes prior to dosing.","Day 1 post-end of infusion, Day 15, Pre-dose on Day 29, Pre-dose and post-dose on Day 57, Day 85 and Day 169|Day 1 Pre and post-dose; Day 15; Day 29 Post dose; Day 57 pre and post dose; Day 85, Day 169|Up to Day 172|Baseline and at Weeks 2, 4, 8 and 12|Up to Day 88|Day 1",{"$nulls":3},"Brest Cedex, France, 29609 Gsk Investigational SiteMarseille, France, 13015 Gsk Investigational SiteMontpellier Cedex 5, France, 34295 Gsk Investigational SiteNantes Cedex 1, France, 44093|Amsterdam, Netherlands, 1105 Az Russian Federation Gsk Investigational SiteIzhevsk, Russian Federation, 426063 Gsk Investigational SiteKemerovo, Russian Federation, 650000 Gsk Investigational SiteMoscow, Russian Federation, 105275 Gsk Investigational SiteMoscow, Russian Federation, 115478 Gsk Investigational SiteSaint Petersburg, Russian Federation, 194291 Gsk Investigational SiteSaint Petersburg, Russian Federation, 196240 Gsk Investigational SiteSaint-Petersburg, Russian Federation, 194354 Gsk Investigational SiteSaratov, Russian Federation, 410028 Gsk Investigational SiteUlyanovsk, Russian Federation, 432063|Wythenshawe, Greater Manchester, United Kingdom, M23 9Lt|Leicester, Leicestershire, United Kingdom, Le3 9Qp|Liverpool, Merseyside, United Kingdom, L7 8Xp|Birmingham, United Kingdom, B9 5Ss Gsk Investigational SiteBradford, United Kingdom, Bd9 6Rj Gsk Investigational SiteEdgbaston, United Kingdom, B15 2Gw",null,"France|Netherlands|United Kingdom","Gsk Investigational Site|, Greater Manchester Gsk Investigational Site|, Leicestershire Gsk Investigational Site|, Merseyside Gsk Investigational Site",{"$nulls":3},"GSK Clinical Trials","2019-09-24","2020-05-25T16:35:50.257","2020-05-26T17:10:42.972","NCT03393806"]
["5ecbf3e6307e3d1b1f8d9c7e","NCT03393806","2019-10-31","GlaxoSmithKline","GSK","Active, not recruiting","Repeat Dose Study of GSK3772847 in Participants With Moderate to Severe Asthma With Allergic Fungal Airway Disease (AFAD)","Gsk-3772847",null,"Yes","['Gsk-3772847']","Unknown",null,"Phase 2",2,18,"Actual","2018-04-18","2019-10-09",{"$nulls":5},"This study is multicenter, double-blinded parallel group design, where participants with moderate to severe asthma with AFAD will be enrolled. Participants will receive three doses of 10 milligrams/kilogram (mg/kg) of GSK3772847 every 4 Weeks versus placebo along with standard of care. Participants will be randomized in 1:1 ratio to receive either 10 mg/kg GSK3772847 intravenously (IV) or matching placebo IV. Participants will receive study treatment on Week 0 (Day 1), Week 4 and Week 8. The total duration of the study will be 28 Weeks and approximately 46 participants will be randomized.",null,"A Double Blind (Sponsor Open) Placebo-controlled, Stratified, Parallel Group Study to Evaluate the Efficacy and Safety of Repeat Doses of GSK3772847 in Participants With Moderate to Severe Asthma With Allergic Fungal Airway Disease (AFAD)",207972,"Asthma","Asthma","Bronchial Diseases","Respiratory","Experimental|Placebo Comparator","Participants receiving GSK3772847|Participants receiving placebo","Participants will be randomized to receive GSK3772847 as IV infusion. Participants will receive three doses ( Day 1, Day 29 and Day 57) of GSK3772847 every 4 weeks|Participants will be randomized to receive matching placebo as IV infusion","Drug","GSK3772847|Placebo","GSK3772847 will be available as 100 mg/vial, white to yellow, uniform lyophilized cake in a 5 milliliter (mL) clear glass vial with closure sealed by red metal and yellow overseal.|Commercially sourced sterile normal saline will be provided as Placebo",null,"Participants receiving GSK3772847|Participants receiving placebo","\n\n * Participant must be at least 18 years of age inclusive, at the time of signing the informed consent.\n * Documented history of physician diagnosed moderate or severe asthma for >=12 months based on Guidelines and treated with inhaled corticosteroid (ICS) and long-acting beta-2-agonist (LABA) for at least 4 months (>=500 micrograms/day [Âµg/day]) fluticasone propionate or equivalent as defined in the guidelines.\n * Pre-bronchodilator FEV1 35-79% of predicted value for participant inclusive\n * FeNO >= 25 parts per billion (ppb) at Screening\n * ACQ-5 score >= 1.5 at Screening\n * Blood eosinophil >=300 cells/microliter at Screening\n * Evidence of allergic fungal airway disease like Fungal sensitization to any of the fungi Aspergillus fumigatus, Penicillium chrysogenum (notatum) at screening measured by serum-specific Immunoglobulin (Ig) E test. A history of exacerbations with at least 1 severe exacerbation (defined as requiring a minimum of 3 days of high-dose oral corticosteroids for asthma symptoms) in the previous 12 months.\n * Body weight within 50-150 kilogram (kg)\n * Both male and female gender. A female participant is eligible to participate if she is not pregnant not breastfeeding, Not a woman of childbearing potential (WOCBP) or A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 16 weeks after the last dose of study treatment.\n * Capable of giving signed informed consent\n\n","\n\n * Historical diagnosis of cystic fibrosis\n * Concurrent respiratory diseases: Presence of a known pre-existing, clinically important respiratory conditions (example pneumonia, pneumothorax, atelectasis segmental or larger, pulmonary fibrotic disease, bronchopulmonary dysplasia, chronic bronchitis, emphysema, chronic obstructive pulmonary disease, or other respiratory abnormalities) other than asthma or AFAD\n * Has a history of chronic or recurrent non-pulmonary infectious disease or ongoing non-pulmonary infection including, but not limited to, chronic renal infection, chronic chest infection, recurrent urinary tract infection (example, recurrent pyelonephritis, chronic non-remitting cystitis), or open, draining skin wound or an ulcer\n * Serious infection within 8 weeks of enrolment, including, but not limited to hepatitis, pneumonia, sepsis, or pyelonephritis; or has been hospitalized for an infection; or has been treated with IV antibiotics for an infection, within 8 weeks prior to the first administration of study drug.\n * Evidence of poorly controlled chronic medical conditions other than asthma, example, participants with known, pre-existing, clinically significant endocrine, autoimmune, metabolic, neurological, renal, cardiovascular, gastrointestinal, hepatic, and hematological or any other system abnormalities that are uncontrolled with standard treatment.\n * Cardiovascular disease: Clinically significant organic heart disease\n * Participants with a diagnosis of malignancy or in the process of investigation for a malignancy. Participants with carcinoma that have not been in complete remission for at least 5 years. Participants who have had carcinoma in situ of the cervix, squamous cell carcinoma and basal cell carcinoma of the skin would not be excluded based on the 5 year waiting period if the participant has been considered cured by treatment.\n * Eosinophilic diseases: Other conditions that could lead to elevated eosinophil such as hyper-eosinophilic syndromes. Participants with a known, pre-existing parasitic infestation within 6 months prior to Screening (Visit 1)\n * Prohibited medications is not permitted within the defined time intervals prior to Screening (Visit 1) and throughout the study.\n * Presence of hepatitis B surface antigen (HBsAg), positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study treatment.\n * A known immunodeficiency such as human immunodeficiency virus infection.\n * Hypersensitivity: significant allergies to humanized monoclonal antibodies or biologic or to any components of the formulation used in this study\n * Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear Ig A dermatosis, toxic epidermal necrolysis, and exfoliative dermatitis).\n * Clinically significant abnormality on 12-lead ECG assessment at screening (Visit 1). Site investigators will be provided with ECG over-read conducted by a centralized independent cardiologist, to assist in evaluation of participant eligibility.\n * Sinus bradycardia <45 beats per minute (bpm), sinus tachycardia >= 110 bpm, multifocal atrial tachycardia (wandering atrial pacemaker with rate >100bpm), evidence of Mobitz II second degree or third degree atrioventricular (AV) block, pathological Q waves (defined as wide [>0.04 seconds] and deep [>0.4 millivolts (mV) (4 millimeter [mm] with 10mm/mV setting)] or >25% of the height of the corresponding R wave, providing the R wave was >0.5mV [5mm with 10mm/mV setting], appearing in at least two contiguous leads, evidence of ventricular ectopic couplets, bigeminy, trigeminy or multifocal premature ventricular complexes, for participants without complete right bundle branch block: QTc for heart rate by Fridericia's formula QTc(F) >= 450 millisecond (msec) or an ECG that is unsuitable for QT measurements, for participants with complete right bundle branch block: QTc(F) >=480 msec or an ECG that is unsuitable for QT measurements, ST-T wave abnormalities, clinically significant conduction abnormalities and clinically significant arrhythmias.\n * Smoking history: current smokers or former smokers with a smoking history >= 10 pack years\n * History of alcohol or illegal substance abuse within 2 years prior to Screening (Visit1).\n * Participants at risk of non-compliance, or unable to comply with the study procedures. Participants who are unable to follow study instructions such as visit schedule and paper diary completion. Participants who have known evidence of lack of adherence to controller medication and/or ability to follow physician's recommendations. Any infirmity, disability, or geographic location that would limit compliance for scheduled visits.",{"$nulls":4},"Actual","2018-01-09","Actual","Actual","2019-12-31","Anticipated","2019-10-01","2018-01-03","2018-01-03","2019-10-29","No","Asthma Control Questionnaire\nAllergic fungal airway disease\nAsthma Quality of Life Questionnaire\nHolter monitoring\nAsthma","Interventional","Treatment","Parallel Assignment","Double (Participant, Investigator)","Randomized","18 Years",null,"All",null,"No","Yes\nIPD for this study will be made available via the Clinical Study Data Request site.",{"$nulls":3},"No","No",{"$nulls":17},"2017-003544-20","EudraCT Number","Change from Baseline in blood eosinophils|Change from Baseline in fractional exhaled nitric oxide (FeNO)","Blood samples will be collected at indicated time points for the assessment of eosinophil|FeNO will be measured using a handheld electronic device","Baseline and up to Day 88","Serum concentrations of GSK3772847|Serum levels of free soluble suppressor of tumorigenicity 2 (ST2)|Serum levels of total soluble ST2|Number of participants with positive result of serum anti-GSK3772847 antibodies post dosing|Titers of serum anti-GSK3772847 antibodies post dosing|Change from Baseline in Asthma Control Questionnaire-5 (ACQ-5) absolute score at Weeks 2, 4, 8 and 12|Change from Baseline in Asthma Quality of Life Questionnaire (AQLQ) total and domain scores at Weeks 2, 4, 8 and 12|Number of responders to ACQ-5|Number of responders to AQLQ|Change from Baseline in forced expiratory volume in 1 second (FEV1)|Change from Baseline in forced vital capacity (FVC)|Number of participants with treatment emergent adverse events (AE) and serious AEs (SAE)|Number of participants with abnormal hematology parameters|Number of participants with abnormal clinical chemistry parameters|Number of participants with abnormal systolic blood pressure (SBP) and diastolic blood pressure (DBP)|Number of participants with abnormal heart rate|Number of participants with abnormal findings in Electrocardiogram (ECG)|Number of participants with abnormal 24-hour Holter findings","Blood samples will be collected at indicated time points for assessment of serum concentrations|Blood samples will be collected at indicated time points to measure free soluble ST2|Blood samples will be collected at indicated time points to measure total soluble ST2|Blood samples will be collected at indicated time points and anti-GSK3772847 antibodies will be assessed using a tiered approach.|ACQ-5 is a 5-item questionnaire that is a measure of the participant's asthma control. The five questions include about the frequency and/or severity of symptoms like nocturnal awakening, activity limitation, shortness of breath and wheeze. The score scales from zero (totally controlled) and 6 (severely uncontrolled)|AQLQ is 32 items four domains questionnaire used for evaluation of impact of asthma treatments on the quality of life of participants. The scores are evaluated from 1 (total impairment) and 7 (no impairment)|ACQ-5 is a 5 question tool used to measure attributes of asthma control and the score ranges from 0 to 6 where 0 is no impairment/limitation and 6 is total impairment/limitation. A responder to ACQ-5 will be defined as a participant who has a decrease from Baseline in ACQ-5 score of 0.5 or more.|AQLQ is a 32 items four domain questionnaire used to measure quality of life participants due to asthma treatment and the scores ranges from 1 to 7 where 1 indicates total impairment and 7 indicates no impairment. A responder to AQLQ will be defined as a participant who has an increase from Baseline in AQLQ score of 0.5 or more.|Spirometry assessment will include pre-bronchodilator FEV1|Spirometry assessment will include pre-bronchodilator FVC|An AE is any untoward medical occurrence in a clinical study participants, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that, at any dose may result in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment.|Laboratory assessment for hematology parameters will include Platelet count, hemoglobin, Red blood cell (RBC) count, hematocrit, Red blood cell distribution width (RDW), RBC indices like mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH) and mean corpuscular hemoglobin concentration (MCHC). White blood cell (WBC) count with differential will include neutrophils, lymphocytes, monocytes, eosinophils and basophils.|Laboratory assessment for clinical chemistry parameters will include blood urea nitrogen (BUN), potassium, calcium, sodium, creatinine, non-fasting glucose, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline phosphate, Gamma-glutamyl transferase (GGT), albumin, phosphorus, carbon dioxide, total protein, creatine phosphokinase (CPK), total and direct bilirubin|Blood pressure will be measured in supine position after 5 minutes rest|Heart rate will be measured in supine position after 5 minutes rest|Single 12-lead ECG will be obtained using an ECG machine that automatically measures heart rate, PR, QRS, QT, and QT interval corrected for heart rate (QTc) and ventricular rate|Holter assessment will be used for quantitative assessment of abnormal rhythm events. Holter monitor will be placed 30-60 minutes prior to dosing.","Day 1 post-end of infusion, Day 15, Pre-dose on Day 29, Pre-dose and post-dose on Day 57, Day 85 and Day 169|Day 1 Pre and post-dose; Day 15; Day 29 Post dose; Day 57 pre and post dose; Day 85, Day 169|Up to Day 172|Baseline and at Weeks 2, 4, 8 and 12|Up to Day 88|Day 1",{"$nulls":3},"Brest Cedex, France, 29609 Gsk Investigational SiteMontpellier Cedex 5, France, 34295 Gsk Investigational SiteNantes Cedex 1, France, 44093|Amsterdam, Netherlands, 1105 Az Russian Federation Gsk Investigational SiteIzhevsk, Russian Federation, 426063 Gsk Investigational SiteKemerovo, Russian Federation, 650000 Gsk Investigational SiteMoscow, Russian Federation, 105275 Gsk Investigational SiteMoscow, Russian Federation, 115478 Gsk Investigational SiteSaint Petersburg, Russian Federation, 194291 Gsk Investigational SiteSaint Petersburg, Russian Federation, 196240 Gsk Investigational SiteSaint-Petersburg, Russian Federation, 194354 Gsk Investigational SiteUlyanovsk, Russian Federation, 432063|Wythenshawe, Greater Manchester, United Kingdom, M23 9Lt|Leicester, Leicestershire, United Kingdom, Le3 9Qp|Liverpool, Merseyside, United Kingdom, L7 8Xp|Birmingham, United Kingdom, B9 5Ss Gsk Investigational SiteBradford, United Kingdom, Bd9 6Rj Gsk Investigational SiteEdgbaston, United Kingdom, B15 2Gw",null,"France|Netherlands|United Kingdom","Gsk Investigational Site|, Greater Manchester Gsk Investigational Site|, Leicestershire Gsk Investigational Site|, Merseyside Gsk Investigational Site",{"$nulls":3},"GSK Clinical Trials","2019-10-29","2020-05-25T16:35:50.288","2020-05-26T17:10:42.972","NCT03393806"]
["5ecbf3e6e2561b1b11905ce9","NCT03393884","2018-01-09","Celsion","CLSN","Not yet recruiting","A Phase I/II Study Evaluating the Dosing, Safety, Efficacy, and Biological Activity of Intraperitoneal GEN-1 Administered in Combination With NACT in Patients Newly Diagnosed With Ovarian Cancer (OVATION II)","Carboplatin|Paclitaxel","DNA Synthesis Inhibitor|Mitosis Inhibitor|Tubulin Inhibitor|Tubulin Inhibitor","Unknown",null,"Unknown",null,"Phase 1/Phase 2",2,90,"Anticipated","2018-04-30","2020-12-31","PFS","Progression Free Survival",{"$nulls":3},"This is a randomized, open label, multicenter trial to evaluate the safety, dosing, efficacy and biological activity of intraperitoneal GEN-1 plus NACT compared to NACT alone.",null,"A Phase I/II Study Evaluating the Dosing, Safety, Efficacy, and Biological Activity of Intraperitoneal GEN-1 (IL-12 Plasmid Formulated With PEG-PEI-Cholesterol Lipopolymer) Administered in Combination With Neoadjuvant Chemotherapy (NACT) in Patients Newly Diagnosed With Advanced Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer","201-17-201","Epithelial Ovarian Cancer\nFallopian Tube Cancer\nPrimary Peritoneal Cancer","Fallopian Tube Cancer|Ovarian Cancer","Oncology Solid Tumor","Oncology","Experimental|Active Comparator","NACT + GEN-1|NACT Alone","The NACT regimen will be paclitaxel 175 mg/m2 IV over 3 hours followed by carboplatin AUC 6 IV over 1 hour on Day 1. This will be repeated every 3 weeks for 6 cycles. GEN-1 100 mg/m2 IP will be administered on Days 8 and 15 of the first NACT cycle and then on Days 1, 8, and 15 of the subsequent 21 day NACT cycles for a total of 17 treatments.|The NACT regimen will be paclitaxel 175 mg/m2 IV over 3 hours followed by carboplatin AUC 6 IV over 1 hour on Day 1. This will be repeated every 3 weeks for 6 cycles.","Biological|Drug","GEN-1|Carboplatin|Paclitaxel","IL-12 Plasmid Formulated with PEG-PEI-Cholesterol Lipopolymer|AUC 6 IV over 1 hour on Day 1 of each cycle|175 mg/m2 IV over 3 hours on Day 1 of each cycle",null,"NACT + GEN-1|NACT Alone","\n\n 1.  Patients must have histologic diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal carcinoma per pre-treatment biopsies by laparoscopy, or interventional radiology or CT guided core biopsy. Histologic documentation of the original primary tumor is required via the pathology report.\n 2.  Patients must have an International Federation of Gynecology and Obstetrics (FIGO) of III or IV.\n 3.  Patients with the following histologic epithelial cell types are eligible: High grade serous adenocarcinoma, endometrioid adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, or adenocarcinoma not otherwise specified (N.O.S.).\n 4.  Patients must have adequate: 1. Bone marrow function: Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl. This ANC cannot have been induced or supported by granulocyte colony stimulating factors. Platelets greater than or equal to 100,000/mcl.\n      2. Renal function: Creatinine â‰¤1.5 x institutional upper limit normal (ULN).\n      3. Hepatic function: Bilirubin â‰¤ 1.5 x ULN. SGOT (AST) and SGPT (ALT) â‰¤ 3.0 x ULN and alkaline phosphatase â‰¤ 2.5 x ULN.\n      4. Neurologic function: Neuropathy (sensory and motor) less than or equal to Grade 1.\n     \n     \n 5.  Patients should be free of active infection requiring parenteral antibiotics or a serious uncontrolled medical illness or disorder within four weeks of study entry.\n 6.  Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to the first treatment. Continuation of hormone replacement therapy is permitted.\n 7.  Patients must have a performance status score of 0, 1 or 2 by Eastern Cooperative Group (ECOG) criteria.\n 8.  Patients of childbearing potential must have a negative serum pregnancy test within 14 days prior to initiation of protocol therapy and be practicing an effective form of contraception. If applicable, patients must discontinue breastfeeding prior to study entry.\n 9.  Patients must have satisfactory results for the baseline laboratory analyses and diagnostic procedures as specified in the protocol.\n 10. Patients must have signed an IRB-approved informed consent and authorization permitting release of personal health information.\n 11. Patients must be at least 18 years old.\n\n","\n\n 1.  Patients who have received prior treatment with GEN-1.\n 2.  History of allergic reactions attributed to compounds of similar chemical or biologic composition to GEN-1 or other agents used in this study.\n 3.  Patients who have received oral or parenteral corticosteroids within 2 weeks of study entry or who have a clinical requirement for ongoing systemic immunosuppressive therapy such as chronic steroid use not related to chemotherapy administration.\n 4.  Patients receiving treatment for active autoimmune disease. \"Active\" refers to any condition currently requiring therapy. Examples of autoimmune disease include systemic lupus erythematosus, multiple sclerosis, inflammatory bowel disease and rheumatoid arthritis.\n 5.  Patients with other invasive malignancies, with the exception of non-melanoma skin cancer and other specific malignancies as noted in the protocol are excluded if there is any evidence of other malignancy being present within the last three years. Patients are also excluded if their previous cancer treatment contraindicates this protocol therapy.\n 6.  Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded. Prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease.\n 7.  Patients who have received prior chemotherapy for any abdominal or pelvic tumor are excluded. Patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease.\n 8.  Patients with known active hepatitis.\n 9.  Patients with concurrent severe medical problems unrelated to the malignancy that would significantly limit full compliance with the study or expose the patient to extreme risk or decreased life expectancy.\n 10. Patients of childbearing potential, not practicing adequate contraception, patients who are pregnant, or patients who are breastfeeding are not eligible for this trial.\n 11. Patients with history or evidence upon physical examination of CNS disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date of treatment on this study.\n 12. Patients with any condition/anomaly that would interfere with the appropriate placement of the IP catheter for study drug administration including: abdominal surgery within 4 weeks of study entry (for reasons other than IP port placement), intestinal dysfunction, or suspected extensive adhesions from prior history or finding at laparoscopy.",{"$nulls":4},"Actual","2018-01-09","Actual","Anticipated","2021-03-31","Anticipated","2018-01-01","2018-01-03","2018-01-03","2018-01-03","Yes",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized",null,null,"Female",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":19},"PFS","The primary objective of the study is to evaluate safety and compare progression free survival between subjects receiving neoadjuvant chemotherapy (NACT) plus GEN-1 versus standard NACT.","The primary analysis for PFS will be conducted after at least 52 events have been observed or after all patients have been followed for at least 12 months, whichever is later.",{"$nulls":14},"2018-01-03","2020-05-25T16:35:50.416","2020-05-26T17:10:42.972","NCT03393884"]
["5ecbf3e6e2561b1b11905cea","NCT03393884","2018-01-10","Celsion","CLSN","Not yet recruiting","Study of GEN-1 With NACT for Treatment of Ovarian Cancer (OVATION II) (OVATION II)","Carboplatin|Paclitaxel","DNA Synthesis Inhibitor|Mitosis Inhibitor|Tubulin Inhibitor|Tubulin Inhibitor","Unknown",null,"Unknown",null,"Phase 1/Phase 2",2,90,"Anticipated","2018-04-30","2020-12-31","PFS","Progression Free Survival",{"$nulls":3},"This is a randomized, open label, multicenter trial to evaluate the safety, dosing, efficacy and biological activity of intraperitoneal GEN-1 plus NACT compared to NACT alone.",null,"A Phase I/II Study Evaluating the Dosing, Safety, Efficacy, and Biological Activity of Intraperitoneal GEN-1 (IL-12 Plasmid Formulated With PEG-PEI-Cholesterol Lipopolymer) Administered in Combination With Neoadjuvant Chemotherapy (NACT) in Patients Newly Diagnosed With Advanced Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer","201-17-201","Epithelial Ovarian Cancer\nFallopian Tube Cancer\nPrimary Peritoneal Cancer","Fallopian Tube Cancer|Ovarian Cancer","Oncology Solid Tumor","Oncology","Experimental|Active Comparator","NACT + GEN-1|NACT Alone","The NACT regimen will be paclitaxel 175 mg/m2 IV over 3 hours followed by carboplatin AUC 6 IV over 1 hour on Day 1. This will be repeated every 3 weeks for 6 cycles. GEN-1 100 mg/m2 IP will be administered on Days 8 and 15 of the first NACT cycle and then on Days 1, 8, and 15 of the subsequent 21 day NACT cycles for a total of 17 treatments.|The NACT regimen will be paclitaxel 175 mg/m2 IV over 3 hours followed by carboplatin AUC 6 IV over 1 hour on Day 1. This will be repeated every 3 weeks for 6 cycles.","Biological|Drug","GEN-1|Carboplatin|Paclitaxel","IL-12 Plasmid Formulated with PEG-PEI-Cholesterol Lipopolymer|AUC 6 IV over 1 hour on Day 1 of each cycle|175 mg/m2 IV over 3 hours on Day 1 of each cycle",null,"NACT + GEN-1|NACT Alone","\n\n 1.  Patients must have histologic diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal carcinoma per pre-treatment biopsies by laparoscopy, or interventional radiology or CT guided core biopsy. Histologic documentation of the original primary tumor is required via the pathology report.\n 2.  Patients must have an International Federation of Gynecology and Obstetrics (FIGO) of III or IV.\n 3.  Patients with the following histologic epithelial cell types are eligible: High grade serous adenocarcinoma, endometrioid adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, or adenocarcinoma not otherwise specified (N.O.S.).\n 4.  Patients must have adequate: 1. Bone marrow function: Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl. This ANC cannot have been induced or supported by granulocyte colony stimulating factors. Platelets greater than or equal to 100,000/mcl.\n      2. Renal function: Creatinine â‰¤1.5 x institutional upper limit normal (ULN).\n      3. Hepatic function: Bilirubin â‰¤ 1.5 x ULN. SGOT (AST) and SGPT (ALT) â‰¤ 3.0 x ULN and alkaline phosphatase â‰¤ 2.5 x ULN.\n      4. Neurologic function: Neuropathy (sensory and motor) less than or equal to Grade 1.\n     \n     \n 5.  Patients should be free of active infection requiring parenteral antibiotics or a serious uncontrolled medical illness or disorder within four weeks of study entry.\n 6.  Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to the first treatment. Continuation of hormone replacement therapy is permitted.\n 7.  Patients must have a performance status score of 0, 1 or 2 by Eastern Cooperative Group (ECOG) criteria.\n 8.  Patients of childbearing potential must have a negative serum pregnancy test within 14 days prior to initiation of protocol therapy and be practicing an effective form of contraception. If applicable, patients must discontinue breastfeeding prior to study entry.\n 9.  Patients must have satisfactory results for the baseline laboratory analyses and diagnostic procedures as specified in the protocol.\n 10. Patients must have signed an IRB-approved informed consent and authorization permitting release of personal health information.\n 11. Patients must be at least 18 years old.\n\n","\n\n 1.  Patients who have received prior treatment with GEN-1.\n 2.  History of allergic reactions attributed to compounds of similar chemical or biologic composition to GEN-1 or other agents used in this study.\n 3.  Patients who have received oral or parenteral corticosteroids within 2 weeks of study entry or who have a clinical requirement for ongoing systemic immunosuppressive therapy such as chronic steroid use not related to chemotherapy administration.\n 4.  Patients receiving treatment for active autoimmune disease. \"Active\" refers to any condition currently requiring therapy. Examples of autoimmune disease include systemic lupus erythematosus, multiple sclerosis, inflammatory bowel disease and rheumatoid arthritis.\n 5.  Patients with other invasive malignancies, with the exception of non-melanoma skin cancer and other specific malignancies as noted in the protocol are excluded if there is any evidence of other malignancy being present within the last three years. Patients are also excluded if their previous cancer treatment contraindicates this protocol therapy.\n 6.  Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded. Prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease.\n 7.  Patients who have received prior chemotherapy for any abdominal or pelvic tumor are excluded. Patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease.\n 8.  Patients with known active hepatitis.\n 9.  Patients with concurrent severe medical problems unrelated to the malignancy that would significantly limit full compliance with the study or expose the patient to extreme risk or decreased life expectancy.\n 10. Patients of childbearing potential, not practicing adequate contraception, patients who are pregnant, or patients who are breastfeeding are not eligible for this trial.\n 11. Patients with history or evidence upon physical examination of CNS disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date of treatment on this study.\n 12. Patients with any condition/anomaly that would interfere with the appropriate placement of the IP catheter for study drug administration including: abdominal surgery within 4 weeks of study entry (for reasons other than IP port placement), intestinal dysfunction, or suspected extensive adhesions from prior history or finding at laparoscopy.",{"$nulls":4},"Actual","2018-01-09","Actual","Anticipated","2021-03-31","Anticipated","2018-01-01","2018-01-03","2018-01-03","2018-01-08","Yes",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized",null,null,"Female",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":19},"PFS","The primary objective of the study is to evaluate safety and compare progression free survival between subjects receiving neoadjuvant chemotherapy (NACT) plus GEN-1 versus standard NACT.","The primary analysis for PFS will be conducted after at least 52 events have been observed or after all patients have been followed for at least 12 months, whichever is later.",{"$nulls":14},"2018-01-08","2020-05-25T16:35:50.604","2020-05-26T17:10:42.972","NCT03393884"]
["5ecbf3e611702c1b1b916a00","NCT03393884","2018-05-01","Celsion","CLSN","Not yet recruiting","Study of GEN-1 With NACT for Treatment of Ovarian Cancer (OVATION II) (OVATION II)","Carboplatin|Paclitaxel","DNA Synthesis Inhibitor|Mitosis Inhibitor|Tubulin Inhibitor|Tubulin Inhibitor","Unknown",null,"Unknown",null,"Phase 1/Phase 2",2,90,"Anticipated","2018-06-30","2022-02-28","PFS","Progression Free Survival",{"$nulls":3},"This is a randomized, open label, multicenter trial to evaluate the safety, dosing, efficacy and biological activity of intraperitoneal GEN-1 plus NACT compared to NACT alone.",null,"A Phase I/II Study Evaluating the Dosing, Safety, Efficacy, and Biological Activity of Intraperitoneal GEN-1 (IL-12 Plasmid Formulated With PEG-PEI-Cholesterol Lipopolymer) Administered in Combination With Neoadjuvant Chemotherapy (NACT) in Patients Newly Diagnosed With Advanced Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer","201-17-201","Epithelial Ovarian Cancer\nFallopian Tube Cancer\nPrimary Peritoneal Cancer","Fallopian Tube Cancer|Ovarian Cancer","Oncology Solid Tumor","Oncology","Experimental|Active Comparator","NACT + GEN-1|NACT Alone","The NACT regimen will be paclitaxel 175 mg/m2 IV over 3 hours followed by carboplatin AUC 6 IV over 1 hour on Day 1. This will be repeated every 3 weeks for 6 cycles. GEN-1 100 mg/m2 IP will be administered on Days 8 and 15 of the first NACT cycle and then on Days 1, 8, and 15 of the subsequent 21 day NACT cycles for a total of 17 treatments.|The NACT regimen will be paclitaxel 175 mg/m2 IV over 3 hours followed by carboplatin AUC 6 IV over 1 hour on Day 1. This will be repeated every 3 weeks for 6 cycles.","Biological|Drug","GEN-1|Carboplatin|Paclitaxel","IL-12 Plasmid Formulated with PEG-PEI-Cholesterol Lipopolymer|AUC 6 IV over 1 hour on Day 1 of each cycle|175 mg/m2 IV over 3 hours on Day 1 of each cycle",null,"NACT + GEN-1|NACT Alone","\n\n 1.  Patients must have histologic diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal carcinoma per pre-treatment biopsies by laparoscopy, or interventional radiology or CT guided core biopsy. Histologic documentation of the original primary tumor is required via the pathology report.\n 2.  Patients must have an International Federation of Gynecology and Obstetrics (FIGO) of III or IV.\n 3.  Patients with the following histologic epithelial cell types are eligible: High grade serous adenocarcinoma, endometrioid adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, or adenocarcinoma not otherwise specified (N.O.S.).\n 4.  Patients must have adequate: 1. Bone marrow function: Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl. This ANC cannot have been induced or supported by granulocyte colony stimulating factors. Platelets greater than or equal to 100,000/mcl.\n      2. Renal function: Creatinine â‰¤1.5 x institutional upper limit normal (ULN).\n      3. Hepatic function: Bilirubin â‰¤ 1.5 x ULN. SGOT (AST) and SGPT (ALT) â‰¤ 3.0 x ULN and alkaline phosphatase â‰¤ 2.5 x ULN.\n      4. Neurologic function: Neuropathy (sensory and motor) less than or equal to Grade 1.\n     \n     \n 5.  Patients should be free of active infection requiring parenteral antibiotics or a serious uncontrolled medical illness or disorder within four weeks of study entry.\n 6.  Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to the first treatment. Continuation of hormone replacement therapy is permitted.\n 7.  Patients must have a performance status score of 0, 1 or 2 by Eastern Cooperative Group (ECOG) criteria.\n 8.  Patients of childbearing potential must have a negative serum pregnancy test within 14 days prior to initiation of protocol therapy and be practicing an effective form of contraception. If applicable, patients must discontinue breastfeeding prior to study entry.\n 9.  Patients must have satisfactory results for the baseline laboratory analyses and diagnostic procedures as specified in the protocol.\n 10. Patients must have signed an IRB-approved informed consent and authorization permitting release of personal health information.\n 11. Patients must be at least 18 years old.\n\n","\n\n 1.  Patients who have received prior treatment with GEN-1.\n 2.  History of allergic reactions attributed to compounds of similar chemical or biologic composition to GEN-1 or other agents used in this study.\n 3.  Patients who have received oral or parenteral corticosteroids within 2 weeks of study entry or who have a clinical requirement for ongoing systemic immunosuppressive therapy such as chronic steroid use not related to chemotherapy administration.\n 4.  Patients receiving treatment for active autoimmune disease. \"Active\" refers to any condition currently requiring therapy. Examples of autoimmune disease include systemic lupus erythematosus, multiple sclerosis, inflammatory bowel disease and rheumatoid arthritis.\n 5.  Patients with other invasive malignancies, with the exception of non-melanoma skin cancer and other specific malignancies as noted in the protocol are excluded if there is any evidence of other malignancy being present within the last three years. Patients are also excluded if their previous cancer treatment contraindicates this protocol therapy.\n 6.  Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded. Prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease.\n 7.  Patients who have received prior chemotherapy for any abdominal or pelvic tumor are excluded. Patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease.\n 8.  Patients with known active hepatitis.\n 9.  Patients with concurrent severe medical problems unrelated to the malignancy that would significantly limit full compliance with the study or expose the patient to extreme risk or decreased life expectancy.\n 10. Patients of childbearing potential, not practicing adequate contraception, patients who are pregnant, or patients who are breastfeeding are not eligible for this trial.\n 11. Patients with history or evidence upon physical examination of CNS disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date of treatment on this study.\n 12. Patients with any condition/anomaly that would interfere with the appropriate placement of the IP catheter for study drug administration including: abdominal surgery within 4 weeks of study entry (for reasons other than IP port placement), intestinal dysfunction, or suspected extensive adhesions from prior history or finding at laparoscopy.",{"$nulls":4},"Actual","2018-01-09","Actual","Anticipated","2023-10-31","Anticipated","2018-04-01","2018-01-03","2018-01-03","2018-04-30","Yes",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"Female",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":19},"PFS","The primary objective of the study is to evaluate safety and compare progression free survival between subjects receiving neoadjuvant chemotherapy (NACT) plus GEN-1 versus standard NACT.","The primary analysis for PFS will be conducted after at least 52 events have been observed or after all patients have been followed for at least 12 months, whichever is later.",{"$nulls":14},"2018-04-30","2020-05-25T16:35:50.562","2020-05-26T17:10:42.972","NCT03393884"]
["5ecbf3e6feab101b1553081e","NCT03393884","2018-07-05","Celsion","CLSN","Recruiting","Study of GEN-1 With NACT for Treatment of Ovarian Cancer (OVATION II) (OVATION II)","Carboplatin|Paclitaxel","DNA Synthesis Inhibitor|Mitosis Inhibitor|Tubulin Inhibitor|Tubulin Inhibitor","Unknown",null,"Unknown",null,"Phase 1/Phase 2",2,90,"Anticipated","2018-06-30","2022-02-28","PFS","Progression Free Survival",{"$nulls":3},"This is a randomized, open label, multicenter trial to evaluate the safety, dosing, efficacy and biological activity of intraperitoneal GEN-1 plus NACT compared to NACT alone.",null,"A Phase I/II Study Evaluating the Dosing, Safety, Efficacy, and Biological Activity of Intraperitoneal GEN-1 (IL-12 Plasmid Formulated With PEG-PEI-Cholesterol Lipopolymer) Administered in Combination With Neoadjuvant Chemotherapy (NACT) in Patients Newly Diagnosed With Advanced Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer","201-17-201","Epithelial Ovarian Cancer\nFallopian Tube Cancer\nPrimary Peritoneal Cancer","Fallopian Tube Cancer|Ovarian Cancer","Oncology Solid Tumor","Oncology","Experimental|Active Comparator","NACT + GEN-1|NACT Alone","The NACT regimen will be paclitaxel 175 mg/m2 IV over 3 hours followed by carboplatin AUC 6 IV over 1 hour on Day 1. This will be repeated every 3 weeks for 6 cycles. GEN-1 100 mg/m2 IP will be administered on Days 8 and 15 of the first NACT cycle and then on Days 1, 8, and 15 of the subsequent 21 day NACT cycles for a total of 17 treatments.|The NACT regimen will be paclitaxel 175 mg/m2 IV over 3 hours followed by carboplatin AUC 6 IV over 1 hour on Day 1. This will be repeated every 3 weeks for 6 cycles.","Biological|Drug","GEN-1|Carboplatin|Paclitaxel","IL-12 Plasmid Formulated with PEG-PEI-Cholesterol Lipopolymer|AUC 6 IV over 1 hour on Day 1 of each cycle|175 mg/m2 IV over 3 hours on Day 1 of each cycle",null,"NACT + GEN-1|NACT Alone","\n\n 1.  Patients must have histologic diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal carcinoma per pre-treatment biopsies by laparoscopy, or interventional radiology or CT guided core biopsy. Histologic documentation of the original primary tumor is required via the pathology report.\n 2.  Patients must have an International Federation of Gynecology and Obstetrics (FIGO) of III or IV.\n 3.  Patients with the following histologic epithelial cell types are eligible: High grade serous adenocarcinoma, endometrioid adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, or adenocarcinoma not otherwise specified (N.O.S.).\n 4.  Patients must have adequate: 1. Bone marrow function: Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl. This ANC cannot have been induced or supported by granulocyte colony stimulating factors. Platelets greater than or equal to 100,000/mcl.\n      2. Renal function: Creatinine â‰¤1.5 x institutional upper limit normal (ULN).\n      3. Hepatic function: Bilirubin â‰¤ 1.5 x ULN. SGOT (AST) and SGPT (ALT) â‰¤ 3.0 x ULN and alkaline phosphatase â‰¤ 2.5 x ULN.\n      4. Neurologic function: Neuropathy (sensory and motor) less than or equal to Grade 1.\n     \n     \n 5.  Patients should be free of active infection requiring parenteral antibiotics or a serious uncontrolled medical illness or disorder within four weeks of study entry.\n 6.  Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to the first treatment. Continuation of hormone replacement therapy is permitted.\n 7.  Patients must have a performance status score of 0, 1 or 2 by Eastern Cooperative Group (ECOG) criteria.\n 8.  Patients of childbearing potential must have a negative serum pregnancy test within 14 days prior to initiation of protocol therapy and be practicing an effective form of contraception. If applicable, patients must discontinue breastfeeding prior to study entry.\n 9.  Patients must have satisfactory results for the baseline laboratory analyses and diagnostic procedures as specified in the protocol.\n 10. Patients must have signed an IRB-approved informed consent and authorization permitting release of personal health information.\n 11. Patients must be at least 18 years old.\n\n","\n\n 1.  Patients who have received prior treatment with GEN-1.\n 2.  History of allergic reactions attributed to compounds of similar chemical or biologic composition to GEN-1 or other agents used in this study.\n 3.  Patients who have received oral or parenteral corticosteroids within 2 weeks of study entry or who have a clinical requirement for ongoing systemic immunosuppressive therapy such as chronic steroid use not related to chemotherapy administration.\n 4.  Patients receiving treatment for active autoimmune disease. \"Active\" refers to any condition currently requiring therapy. Examples of autoimmune disease include systemic lupus erythematosus, multiple sclerosis, inflammatory bowel disease and rheumatoid arthritis.\n 5.  Patients with other invasive malignancies, with the exception of non-melanoma skin cancer and other specific malignancies as noted in the protocol are excluded if there is any evidence of other malignancy being present within the last three years. Patients are also excluded if their previous cancer treatment contraindicates this protocol therapy.\n 6.  Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded. Prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease.\n 7.  Patients who have received prior chemotherapy for any abdominal or pelvic tumor are excluded. Patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease.\n 8.  Patients with known active hepatitis.\n 9.  Patients with concurrent severe medical problems unrelated to the malignancy that would significantly limit full compliance with the study or expose the patient to extreme risk or decreased life expectancy.\n 10. Patients of childbearing potential, not practicing adequate contraception, patients who are pregnant, or patients who are breastfeeding are not eligible for this trial.\n 11. Patients with history or evidence upon physical examination of CNS disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date of treatment on this study.\n 12. Patients with any condition/anomaly that would interfere with the appropriate placement of the IP catheter for study drug administration including: abdominal surgery within 4 weeks of study entry (for reasons other than IP port placement), intestinal dysfunction, or suspected extensive adhesions from prior history or finding at laparoscopy.",{"$nulls":4},"Actual","2018-01-09","Actual","Anticipated","2023-10-31","Anticipated","2018-07-01","2018-01-03","2018-01-03","2018-07-03","Yes",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"Female",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":19},"PFS","The primary objective of the study is to evaluate safety and compare progression free survival between subjects receiving neoadjuvant chemotherapy (NACT) plus GEN-1 versus standard NACT.","The primary analysis for PFS will be conducted after at least 52 events have been observed or after all patients have been followed for at least 12 months, whichever is later.",{"$nulls":6},"Mobile, Alabama, United States, 36604|Saint Louis, Missouri, United States, 63110","Alabama|Missouri","United States","Mitchell Cancer Institute (University Of South Alabama)|Washington University School Of Medicine In St. Louis",{"$nulls":4},"2018-07-03","2020-05-25T16:35:50.469","2020-05-26T17:10:42.972","NCT03393884"]
["5ecbf3e6307e3d1b1f8d9c7f","NCT03393884","2018-09-17","Celsion","CLSN","Recruiting","Study of GEN-1 With NACT for Treatment of Ovarian Cancer (OVATION II) (OVATION II)","Carboplatin|Paclitaxel","DNA Synthesis Inhibitor|Mitosis Inhibitor|Tubulin Inhibitor|Tubulin Inhibitor","Unknown",null,"Unknown",null,"Phase 1/Phase 2",2,90,"Anticipated","2018-09-05","2022-02-28","PFS","Progression Free Survival",{"$nulls":3},"This is a randomized, open label, multicenter trial to evaluate the safety, dosing, efficacy and biological activity of intraperitoneal GEN-1 plus NACT compared to NACT alone.",null,"A Phase I/II Study Evaluating the Dosing, Safety, Efficacy, and Biological Activity of Intraperitoneal GEN-1 (IL-12 Plasmid Formulated With PEG-PEI-Cholesterol Lipopolymer) Administered in Combination With Neoadjuvant Chemotherapy (NACT) in Patients Newly Diagnosed With Advanced Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer","201-17-201","Epithelial Ovarian Cancer\nFallopian Tube Cancer\nPrimary Peritoneal Cancer","Fallopian Tube Cancer|Ovarian Cancer","Oncology Solid Tumor","Oncology","Experimental|Active Comparator","NACT + GEN-1|NACT Alone","The NACT regimen will be paclitaxel 175 mg/m2 IV over 3 hours followed by carboplatin AUC 6 IV over 1 hour on Day 1. This will be repeated every 3 weeks for 6 cycles. GEN-1 100 mg/m2 IP will be administered on Days 8 and 15 of the first NACT cycle and then on Days 1, 8, and 15 of the subsequent 21 day NACT cycles for a total of 17 treatments.|The NACT regimen will be paclitaxel 175 mg/m2 IV over 3 hours followed by carboplatin AUC 6 IV over 1 hour on Day 1. This will be repeated every 3 weeks for 6 cycles.","Biological|Drug","GEN-1|Carboplatin|Paclitaxel","IL-12 Plasmid Formulated with PEG-PEI-Cholesterol Lipopolymer|AUC 6 IV over 1 hour on Day 1 of each cycle|175 mg/m2 IV over 3 hours on Day 1 of each cycle",null,"NACT + GEN-1|NACT Alone","\n\n 1.  Patients must have histologic diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal carcinoma per pre-treatment biopsies by laparoscopy, or interventional radiology or CT guided core biopsy. Histologic documentation of the original primary tumor is required via the pathology report.\n 2.  Patients must have an International Federation of Gynecology and Obstetrics (FIGO) of III or IV.\n 3.  Patients with the following histologic epithelial cell types are eligible: High grade serous adenocarcinoma, endometrioid adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, or adenocarcinoma not otherwise specified (N.O.S.).\n 4.  Patients must have adequate: 1. Bone marrow function: Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl. This ANC cannot have been induced or supported by granulocyte colony stimulating factors. Platelets greater than or equal to 100,000/mcl.\n      2. Renal function: Creatinine â‰¤1.5 x institutional upper limit normal (ULN).\n      3. Hepatic function: Bilirubin â‰¤ 1.5 x ULN. SGOT (AST) and SGPT (ALT) â‰¤ 3.0 x ULN and alkaline phosphatase â‰¤ 2.5 x ULN.\n      4. Neurologic function: Neuropathy (sensory and motor) less than or equal to Grade 1.\n     \n     \n 5.  Patients should be free of active infection requiring parenteral antibiotics or a serious uncontrolled medical illness or disorder within four weeks of study entry.\n 6.  Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to the first treatment. Continuation of hormone replacement therapy is permitted.\n 7.  Patients must have a performance status score of 0, 1 or 2 by Eastern Cooperative Group (ECOG) criteria.\n 8.  Patients of childbearing potential must have a negative serum pregnancy test within 14 days prior to initiation of protocol therapy and be practicing an effective form of contraception. If applicable, patients must discontinue breastfeeding prior to study entry.\n 9.  Patients must have satisfactory results for the baseline laboratory analyses and diagnostic procedures as specified in the protocol.\n 10. Patients must have signed an IRB-approved informed consent and authorization permitting release of personal health information.\n 11. Patients must be at least 18 years old.\n\n","\n\n 1.  Patients who have received prior treatment with GEN-1.\n 2.  History of allergic reactions attributed to compounds of similar chemical or biologic composition to GEN-1 or other agents used in this study.\n 3.  Patients who have received oral or parenteral corticosteroids within 2 weeks of study entry or who have a clinical requirement for ongoing systemic immunosuppressive therapy such as chronic steroid use not related to chemotherapy administration.\n 4.  Patients receiving treatment for active autoimmune disease. \"Active\" refers to any condition currently requiring therapy. Examples of autoimmune disease include systemic lupus erythematosus, multiple sclerosis, inflammatory bowel disease and rheumatoid arthritis.\n 5.  Patients with other invasive malignancies, with the exception of non-melanoma skin cancer and other specific malignancies as noted in the protocol are excluded if there is any evidence of other malignancy being present within the last three years. Patients are also excluded if their previous cancer treatment contraindicates this protocol therapy.\n 6.  Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded. Prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease.\n 7.  Patients who have received prior chemotherapy for any abdominal or pelvic tumor are excluded. Patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease.\n 8.  Patients with known active hepatitis.\n 9.  Patients with concurrent severe medical problems unrelated to the malignancy that would significantly limit full compliance with the study or expose the patient to extreme risk or decreased life expectancy.\n 10. Patients of childbearing potential, not practicing adequate contraception, patients who are pregnant, or patients who are breastfeeding are not eligible for this trial.\n 11. Patients with history or evidence upon physical examination of CNS disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date of treatment on this study.\n 12. Patients with any condition/anomaly that would interfere with the appropriate placement of the IP catheter for study drug administration including: abdominal surgery within 4 weeks of study entry (for reasons other than IP port placement), intestinal dysfunction, or suspected extensive adhesions from prior history or finding at laparoscopy.",{"$nulls":4},"Actual","2018-01-09","Actual","Anticipated","2023-10-31","Anticipated","2018-09-01","2018-01-03","2018-01-03","2018-09-14","Yes",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"Female",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":19},"PFS","The primary objective of the study is to evaluate safety and compare progression free survival between subjects receiving neoadjuvant chemotherapy (NACT) plus GEN-1 versus standard NACT.","The primary analysis for PFS will be conducted after at least 52 events have been observed or after all patients have been followed for at least 12 months, whichever is later.",{"$nulls":6},"Mobile, Alabama, United States, 36604|Saint Louis, Missouri, United States, 63110","Alabama|Missouri","United States","Mitchell Cancer Institute (University Of South Alabama)|Washington University School Of Medicine In St. Louis",{"$nulls":4},"2018-09-14","2020-05-25T16:35:50.516","2020-05-26T17:10:42.972","NCT03393884"]
["5ecbf3e7feab101b15530820","NCT03393884","2018-10-10","Celsion","CLSN","Recruiting","Study of GEN-1 With NACT for Treatment of Ovarian Cancer (OVATION II) (OVATION II)","Carboplatin|Paclitaxel","DNA Synthesis Inhibitor|Mitosis Inhibitor|Tubulin Inhibitor|Tubulin Inhibitor","Unknown",null,"Unknown",null,"Phase 1/Phase 2",2,90,"Anticipated","2018-09-05","2022-02-28","PFS","Progression Free Survival",{"$nulls":3},"This is a randomized, open label, multicenter trial to evaluate the safety, dosing, efficacy and biological activity of intraperitoneal GEN-1 plus NACT compared to NACT alone.",null,"A Phase I/II Study Evaluating the Dosing, Safety, Efficacy, and Biological Activity of Intraperitoneal GEN-1 (IL-12 Plasmid Formulated With PEG-PEI-Cholesterol Lipopolymer) Administered in Combination With Neoadjuvant Chemotherapy (NACT) in Patients Newly Diagnosed With Advanced Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer","201-17-201","Epithelial Ovarian Cancer\nFallopian Tube Cancer\nPrimary Peritoneal Cancer","Fallopian Tube Cancer|Ovarian Cancer","Oncology Solid Tumor","Oncology","Experimental|Active Comparator","NACT + GEN-1|NACT Alone","The NACT regimen will be paclitaxel 175 mg/m2 IV over 3 hours followed by carboplatin AUC 6 IV over 1 hour on Day 1. This will be repeated every 3 weeks for 6 cycles. GEN-1 100 mg/m2 IP will be administered on Days 8 and 15 of the first NACT cycle and then on Days 1, 8, and 15 of the subsequent 21 day NACT cycles for a total of 17 treatments.|The NACT regimen will be paclitaxel 175 mg/m2 IV over 3 hours followed by carboplatin AUC 6 IV over 1 hour on Day 1. This will be repeated every 3 weeks for 6 cycles.","Biological|Drug","GEN-1|Carboplatin|Paclitaxel","IL-12 Plasmid Formulated with PEG-PEI-Cholesterol Lipopolymer|AUC 6 IV over 1 hour on Day 1 of each cycle|175 mg/m2 IV over 3 hours on Day 1 of each cycle",null,"NACT + GEN-1|NACT Alone","\n\n 1.  Patients must have histologic diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal carcinoma per pre-treatment biopsies by laparoscopy, or interventional radiology or CT guided core biopsy. Histologic documentation of the original primary tumor is required via the pathology report.\n 2.  Patients must have an International Federation of Gynecology and Obstetrics (FIGO) of III or IV.\n 3.  Patients with the following histologic epithelial cell types are eligible: High grade serous adenocarcinoma, endometrioid adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, or adenocarcinoma not otherwise specified (N.O.S.).\n 4.  Patients must have adequate: 1. Bone marrow function: Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl. This ANC cannot have been induced or supported by granulocyte colony stimulating factors. Platelets greater than or equal to 100,000/mcl.\n      2. Renal function: Creatinine â‰¤1.5 x institutional upper limit normal (ULN).\n      3. Hepatic function: Bilirubin â‰¤ 1.5 x ULN. SGOT (AST) and SGPT (ALT) â‰¤ 3.0 x ULN and alkaline phosphatase â‰¤ 2.5 x ULN.\n      4. Neurologic function: Neuropathy (sensory and motor) less than or equal to Grade 1.\n     \n     \n 5.  Patients should be free of active infection requiring parenteral antibiotics or a serious uncontrolled medical illness or disorder within four weeks of study entry.\n 6.  Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to the first treatment. Continuation of hormone replacement therapy is permitted.\n 7.  Patients must have a performance status score of 0, 1 or 2 by Eastern Cooperative Group (ECOG) criteria.\n 8.  Patients of childbearing potential must have a negative serum pregnancy test within 14 days prior to initiation of protocol therapy and be practicing an effective form of contraception. If applicable, patients must discontinue breastfeeding prior to study entry.\n 9.  Patients must have satisfactory results for the baseline laboratory analyses and diagnostic procedures as specified in the protocol.\n 10. Patients must have signed an IRB-approved informed consent and authorization permitting release of personal health information.\n 11. Patients must be at least 18 years old.\n\n","\n\n 1.  Patients who have received prior treatment with GEN-1.\n 2.  History of allergic reactions attributed to compounds of similar chemical or biologic composition to GEN-1 or other agents used in this study.\n 3.  Patients who have received oral or parenteral corticosteroids within 2 weeks of study entry or who have a clinical requirement for ongoing systemic immunosuppressive therapy such as chronic steroid use not related to chemotherapy administration.\n 4.  Patients receiving treatment for active autoimmune disease. \"Active\" refers to any condition currently requiring therapy. Examples of autoimmune disease include systemic lupus erythematosus, multiple sclerosis, inflammatory bowel disease and rheumatoid arthritis.\n 5.  Patients with other invasive malignancies, with the exception of non-melanoma skin cancer and other specific malignancies as noted in the protocol are excluded if there is any evidence of other malignancy being present within the last three years. Patients are also excluded if their previous cancer treatment contraindicates this protocol therapy.\n 6.  Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded. Prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease.\n 7.  Patients who have received prior chemotherapy for any abdominal or pelvic tumor are excluded. Patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease.\n 8.  Patients with known active hepatitis.\n 9.  Patients with concurrent severe medical problems unrelated to the malignancy that would significantly limit full compliance with the study or expose the patient to extreme risk or decreased life expectancy.\n 10. Patients of childbearing potential, not practicing adequate contraception, patients who are pregnant, or patients who are breastfeeding are not eligible for this trial.\n 11. Patients with history or evidence upon physical examination of CNS disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date of treatment on this study.\n 12. Patients with any condition/anomaly that would interfere with the appropriate placement of the IP catheter for study drug administration including: abdominal surgery within 4 weeks of study entry (for reasons other than IP port placement), intestinal dysfunction, or suspected extensive adhesions from prior history or finding at laparoscopy.",{"$nulls":4},"Actual","2018-01-09","Actual","Anticipated","2023-10-31","Anticipated","2018-10-01","2018-01-03","2018-01-03","2018-10-09","Yes",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"Female",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":19},"PFS","The primary objective of the study is to evaluate safety and compare progression free survival between subjects receiving neoadjuvant chemotherapy (NACT) plus GEN-1 versus standard NACT.","The primary analysis for PFS will be conducted after at least 52 events have been observed or after all patients have been followed for at least 12 months, whichever is later.",{"$nulls":6},"Mobile, Alabama, United States, 36604|Saint Louis, Missouri, United States, 63110","Alabama|Missouri","United States","Mitchell Cancer Institute (University Of South Alabama)|Washington University School Of Medicine In St. Louis",{"$nulls":4},"2018-10-09","2020-05-25T16:35:51.396","2020-05-26T17:10:42.972","NCT03393884"]
["5ecbf3e611702c1b1b916a01","NCT03393884","2018-11-01","Celsion","CLSN","Recruiting","Study of GEN-1 With NACT for Treatment of Ovarian Cancer (OVATION II) (OVATION II)","Carboplatin|Paclitaxel","DNA Synthesis Inhibitor|Mitosis Inhibitor|Tubulin Inhibitor|Tubulin Inhibitor","Unknown",null,"Unknown",null,"Phase 1/Phase 2",2,130,"Anticipated","2018-09-05","2022-02-28","PFS","Progression Free Survival",{"$nulls":3},"This is a randomized, open label, multicenter trial to evaluate the safety, dosing, efficacy and biological activity of intraperitoneal GEN-1 plus NACT compared to NACT alone.",null,"A Phase I/II Study Evaluating the Dosing, Safety, Efficacy, and Biological Activity of Intraperitoneal GEN-1 (IL-12 Plasmid Formulated With PEG-PEI-Cholesterol Lipopolymer) Administered in Combination With Neoadjuvant Chemotherapy (NACT) in Patients Newly Diagnosed With Advanced Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer","201-17-201","Epithelial Ovarian Cancer\nFallopian Tube Cancer\nPrimary Peritoneal Cancer","Fallopian Tube Cancer|Ovarian Cancer","Oncology Solid Tumor","Oncology","Experimental|Active Comparator","NACT + GEN-1|NACT Alone","The NACT regimen will be paclitaxel 175 mg/m2 IV over 3 hours followed by carboplatin AUC 6 IV over 1 hour on Day 1. This will be repeated every 3 weeks for 6 cycles. GEN-1 100 mg/m2 IP will be administered on Days 8 and 15 of the first NACT cycle and then on Days 1, 8, and 15 of the subsequent 21 day NACT cycles for a total of 17 treatments.|The NACT regimen will be paclitaxel 175 mg/m2 IV over 3 hours followed by carboplatin AUC 6 IV over 1 hour on Day 1. This will be repeated every 3 weeks for 6 cycles.","Biological|Drug","GEN-1|Carboplatin|Paclitaxel","IL-12 Plasmid Formulated with PEG-PEI-Cholesterol Lipopolymer|AUC 6 IV over 1 hour on Day 1 of each cycle|175 mg/m2 IV over 3 hours on Day 1 of each cycle",null,"NACT + GEN-1|NACT Alone","\n\n 1.  Patients must have histologic diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal carcinoma per pre-treatment biopsies by laparoscopy, or interventional radiology or CT guided core biopsy. Histologic documentation of the original primary tumor is required via the pathology report.\n 2.  Patients must have an International Federation of Gynecology and Obstetrics (FIGO) of III or IV.\n 3.  Patients with the following histologic epithelial cell types are eligible: High grade serous adenocarcinoma, endometrioid adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, or adenocarcinoma not otherwise specified (N.O.S.).\n 4.  Patients must have adequate: 1. Bone marrow function: Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl. This ANC cannot have been induced or supported by granulocyte colony stimulating factors. Platelets greater than or equal to 100,000/mcl.\n      2. Renal function: Creatinine â‰¤1.5 x institutional upper limit normal (ULN).\n      3. Hepatic function: Bilirubin â‰¤ 1.5 x ULN. SGOT (AST) and SGPT (ALT) â‰¤ 3.0 x ULN and alkaline phosphatase â‰¤ 2.5 x ULN.\n      4. Neurologic function: Neuropathy (sensory and motor) less than or equal to Grade 1.\n     \n     \n 5.  Patients should be free of active infection requiring parenteral antibiotics or a serious uncontrolled medical illness or disorder within four weeks of study entry.\n 6.  Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to the first treatment. Continuation of hormone replacement therapy is permitted.\n 7.  Patients must have a performance status score of 0, 1 or 2 by Eastern Cooperative Group (ECOG) criteria.\n 8.  Patients of childbearing potential must have a negative serum pregnancy test within 14 days prior to initiation of protocol therapy and be practicing an effective form of contraception. If applicable, patients must discontinue breastfeeding prior to study entry.\n 9.  Patients must have satisfactory results for the baseline laboratory analyses and diagnostic procedures as specified in the protocol.\n 10. Patients must have signed an IRB-approved informed consent and authorization permitting release of personal health information.\n 11. Patients must be at least 18 years old.\n\n","\n\n 1.  Patients who have received prior treatment with GEN-1.\n 2.  History of allergic reactions attributed to compounds of similar chemical or biologic composition to GEN-1 or other agents used in this study.\n 3.  Patients who have received oral or parenteral corticosteroids within 2 weeks of study entry or who have a clinical requirement for ongoing systemic immunosuppressive therapy such as chronic steroid use not related to chemotherapy administration.\n 4.  Patients receiving treatment for active autoimmune disease. \"Active\" refers to any condition currently requiring therapy. Examples of autoimmune disease include systemic lupus erythematosus, multiple sclerosis, inflammatory bowel disease and rheumatoid arthritis.\n 5.  Patients with other invasive malignancies, with the exception of non-melanoma skin cancer and other specific malignancies as noted in the protocol are excluded if there is any evidence of other malignancy being present within the last three years. Patients are also excluded if their previous cancer treatment contraindicates this protocol therapy.\n 6.  Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded. Prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease.\n 7.  Patients who have received prior chemotherapy for any abdominal or pelvic tumor are excluded. Patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease.\n 8.  Patients with known active hepatitis.\n 9.  Patients with concurrent severe medical problems unrelated to the malignancy that would significantly limit full compliance with the study or expose the patient to extreme risk or decreased life expectancy.\n 10. Patients of childbearing potential, not practicing adequate contraception, patients who are pregnant, or patients who are breastfeeding are not eligible for this trial.\n 11. Patients with history or evidence upon physical examination of CNS disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date of treatment on this study.\n 12. Patients with any condition/anomaly that would interfere with the appropriate placement of the IP catheter for study drug administration including: abdominal surgery within 4 weeks of study entry (for reasons other than IP port placement), intestinal dysfunction, or suspected extensive adhesions from prior history or finding at laparoscopy.",{"$nulls":4},"Actual","2018-01-09","Actual","Anticipated","2023-10-31","Anticipated","2018-10-01","2018-01-03","2018-01-03","2018-10-31","Yes",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"Female",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":19},"PFS","The primary objective of the study is to evaluate safety and compare progression free survival between subjects receiving neoadjuvant chemotherapy (NACT) plus GEN-1 versus standard NACT.","The primary analysis for PFS will be conducted after at least 52 events have been observed or after all patients have been followed for at least 12 months, whichever is later.",{"$nulls":6},"Mobile, Alabama, United States, 36604|Saint Louis, Missouri, United States, 63110","Alabama|Missouri","United States","Mitchell Cancer Institute (University Of South Alabama)|Washington University School Of Medicine In St. Louis",{"$nulls":4},"2018-10-31","2020-05-25T16:35:50.782","2020-05-26T17:10:42.972","NCT03393884"]
["5ecbf3e6fe30261b1a0481ef","NCT03393884","2018-11-06","Celsion","CLSN","Recruiting","Study of GEN-1 With NACT for Treatment of Ovarian Cancer (OVATION II) (OVATION II)","Carboplatin|Paclitaxel","DNA Synthesis Inhibitor|Mitosis Inhibitor|Tubulin Inhibitor|Tubulin Inhibitor","Unknown",null,"Unknown",null,"Phase 1/Phase 2",2,130,"Anticipated","2018-09-05","2022-02-28","PFS","Progression Free Survival",{"$nulls":3},"This is a randomized, open label, multicenter trial to evaluate the safety, dosing, efficacy and biological activity of intraperitoneal GEN-1 plus NACT compared to NACT alone.",null,"A Phase I/II Study Evaluating the Dosing, Safety, Efficacy, and Biological Activity of Intraperitoneal GEN-1 (IL-12 Plasmid Formulated With PEG-PEI-Cholesterol Lipopolymer) Administered in Combination With Neoadjuvant Chemotherapy (NACT) in Patients Newly Diagnosed With Advanced Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer","201-17-201","Epithelial Ovarian Cancer\nFallopian Tube Cancer\nPrimary Peritoneal Cancer","Fallopian Tube Cancer|Ovarian Cancer","Oncology Solid Tumor","Oncology","Experimental|Active Comparator","NACT + GEN-1|NACT Alone","The NACT regimen will be paclitaxel 175 mg/m2 IV over 3 hours followed by carboplatin AUC 6 IV over 1 hour on Day 1. This will be repeated every 3 weeks for 6 cycles. GEN-1 100 mg/m2 IP will be administered on Days 8 and 15 of the first NACT cycle and then on Days 1, 8, and 15 of the subsequent 21 day NACT cycles for a total of 17 treatments.|The NACT regimen will be paclitaxel 175 mg/m2 IV over 3 hours followed by carboplatin AUC 6 IV over 1 hour on Day 1. This will be repeated every 3 weeks for 6 cycles.","Biological|Drug","GEN-1|Carboplatin|Paclitaxel","IL-12 Plasmid Formulated with PEG-PEI-Cholesterol Lipopolymer|AUC 6 IV over 1 hour on Day 1 of each cycle|175 mg/m2 IV over 3 hours on Day 1 of each cycle",null,"NACT + GEN-1|NACT Alone","\n\n 1.  Patients must have histologic diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal carcinoma per pre-treatment biopsies by laparoscopy, or interventional radiology or CT guided core biopsy. Histologic documentation of the original primary tumor is required via the pathology report.\n 2.  Patients must have an International Federation of Gynecology and Obstetrics (FIGO) of III or IV.\n 3.  Patients with the following histologic epithelial cell types are eligible: High grade serous adenocarcinoma, endometrioid adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, or adenocarcinoma not otherwise specified (N.O.S.).\n 4.  Patients must have adequate: 1. Bone marrow function: Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl. This ANC cannot have been induced or supported by granulocyte colony stimulating factors. Platelets greater than or equal to 100,000/mcl.\n      2. Renal function: Creatinine â‰¤1.5 x institutional upper limit normal (ULN).\n      3. Hepatic function: Bilirubin â‰¤ 1.5 x ULN. SGOT (AST) and SGPT (ALT) â‰¤ 3.0 x ULN and alkaline phosphatase â‰¤ 2.5 x ULN.\n      4. Neurologic function: Neuropathy (sensory and motor) less than or equal to Grade 1.\n     \n     \n 5.  Patients should be free of active infection requiring parenteral antibiotics or a serious uncontrolled medical illness or disorder within four weeks of study entry.\n 6.  Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to the first treatment. Continuation of hormone replacement therapy is permitted.\n 7.  Patients must have a performance status score of 0, 1 or 2 by Eastern Cooperative Group (ECOG) criteria.\n 8.  Patients of childbearing potential must have a negative serum pregnancy test within 14 days prior to initiation of protocol therapy and be practicing an effective form of contraception. If applicable, patients must discontinue breastfeeding prior to study entry.\n 9.  Patients must have satisfactory results for the baseline laboratory analyses and diagnostic procedures as specified in the protocol.\n 10. Patients must have signed an IRB-approved informed consent and authorization permitting release of personal health information.\n 11. Patients must be at least 18 years old.\n\n","\n\n 1.  Patients who have received prior treatment with GEN-1.\n 2.  History of allergic reactions attributed to compounds of similar chemical or biologic composition to GEN-1 or other agents used in this study.\n 3.  Patients who have received oral or parenteral corticosteroids within 2 weeks of study entry or who have a clinical requirement for ongoing systemic immunosuppressive therapy such as chronic steroid use not related to chemotherapy administration.\n 4.  Patients receiving treatment for active autoimmune disease. \"Active\" refers to any condition currently requiring therapy. Examples of autoimmune disease include systemic lupus erythematosus, multiple sclerosis, inflammatory bowel disease and rheumatoid arthritis.\n 5.  Patients with other invasive malignancies, with the exception of non-melanoma skin cancer and other specific malignancies as noted in the protocol are excluded if there is any evidence of other malignancy being present within the last three years. Patients are also excluded if their previous cancer treatment contraindicates this protocol therapy.\n 6.  Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded. Prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease.\n 7.  Patients who have received prior chemotherapy for any abdominal or pelvic tumor are excluded. Patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease.\n 8.  Patients with known active hepatitis.\n 9.  Patients with concurrent severe medical problems unrelated to the malignancy that would significantly limit full compliance with the study or expose the patient to extreme risk or decreased life expectancy.\n 10. Patients of childbearing potential, not practicing adequate contraception, patients who are pregnant, or patients who are breastfeeding are not eligible for this trial.\n 11. Patients with history or evidence upon physical examination of CNS disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date of treatment on this study.\n 12. Patients with any condition/anomaly that would interfere with the appropriate placement of the IP catheter for study drug administration including: abdominal surgery within 4 weeks of study entry (for reasons other than IP port placement), intestinal dysfunction, or suspected extensive adhesions from prior history or finding at laparoscopy.",{"$nulls":4},"Actual","2018-01-09","Actual","Anticipated","2023-10-31","Anticipated","2018-11-01","2018-01-03","2018-01-03","2018-11-05","Yes",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"Female",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":19},"PFS","The primary objective of the study is to evaluate safety and compare progression free survival between subjects receiving neoadjuvant chemotherapy (NACT) plus GEN-1 versus standard NACT.","The primary analysis for PFS will be conducted after at least 52 events have been observed or after all patients have been followed for at least 12 months, whichever is later.",{"$nulls":6},"Birmingham, Alabama, United States, 35233|Saint Louis, Missouri, United States, 63110|Oklahoma City, Oklahoma, United States, 73104|Pittsburgh, Pennsylvania, United States, 15213|Nashville, Tennessee, United States, 37203|Milwaukee, Wisconsin, United States, 53226","Alabama|Missouri|Oklahoma|Pennsylvania|Tennessee|Wisconsin","United States","University Of Alabama Birmingham|Washington University School Of Medicine In St. Louis|Stephenson Cancer Center - Oklahoma University|University Of Pittsburgh Medical Center|Vanderbilt-Ingram Cancer Center|Medical College Of Wisconsin",{"$nulls":4},"2018-11-05","2020-05-25T16:35:50.743","2020-05-26T17:10:42.972","NCT03393884"]
["5ecbf3e7fe30261b1a0481f0","NCT03393884","2018-11-26","Celsion","CLSN","Recruiting","Study of GEN-1 With NACT for Treatment of Ovarian Cancer (OVATION II) (OVATION II)","Carboplatin|Paclitaxel","DNA Synthesis Inhibitor|Mitosis Inhibitor|Tubulin Inhibitor|Tubulin Inhibitor","Unknown",null,"Unknown",null,"Phase 1/Phase 2",2,130,"Anticipated","2018-09-05","2022-02-28","PFS","Progression Free Survival",{"$nulls":3},"This is a randomized, open label, multicenter trial to evaluate the safety, dosing, efficacy and biological activity of intraperitoneal GEN-1 plus NACT compared to NACT alone.",null,"A Phase I/II Study Evaluating the Dosing, Safety, Efficacy, and Biological Activity of Intraperitoneal GEN-1 (IL-12 Plasmid Formulated With PEG-PEI-Cholesterol Lipopolymer) Administered in Combination With Neoadjuvant Chemotherapy (NACT) in Patients Newly Diagnosed With Advanced Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer","201-17-201","Epithelial Ovarian Cancer\nFallopian Tube Cancer\nPrimary Peritoneal Cancer","Fallopian Tube Cancer|Ovarian Cancer","Oncology Solid Tumor","Oncology","Experimental|Active Comparator","NACT + GEN-1|NACT Alone","The NACT regimen will be paclitaxel 175 mg/m2 IV over 3 hours followed by carboplatin AUC 6 IV over 1 hour on Day 1. This will be repeated every 3 weeks for 6 cycles. GEN-1 100 mg/m2 IP will be administered on Days 8 and 15 of the first NACT cycle and then on Days 1, 8, and 15 of the subsequent 21 day NACT cycles for a total of 17 treatments.|The NACT regimen will be paclitaxel 175 mg/m2 IV over 3 hours followed by carboplatin AUC 6 IV over 1 hour on Day 1. This will be repeated every 3 weeks for 6 cycles.","Biological|Drug","GEN-1|Carboplatin|Paclitaxel","IL-12 Plasmid Formulated with PEG-PEI-Cholesterol Lipopolymer|AUC 6 IV over 1 hour on Day 1 of each cycle|175 mg/m2 IV over 3 hours on Day 1 of each cycle",null,"NACT + GEN-1|NACT Alone","\n\n 1.  Patients must have histologic diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal carcinoma per pre-treatment biopsies by laparoscopy, or interventional radiology or CT guided core biopsy. Histologic documentation of the original primary tumor is required via the pathology report.\n 2.  Patients must have an International Federation of Gynecology and Obstetrics (FIGO) of III or IV.\n 3.  Patients with the following histologic epithelial cell types are eligible: High grade serous adenocarcinoma, endometrioid adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, or adenocarcinoma not otherwise specified (N.O.S.).\n 4.  Patients must have adequate: 1. Bone marrow function: Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl. This ANC cannot have been induced or supported by granulocyte colony stimulating factors. Platelets greater than or equal to 100,000/mcl.\n      2. Renal function: Creatinine â‰¤1.5 x institutional upper limit normal (ULN).\n      3. Hepatic function: Bilirubin â‰¤ 1.5 x ULN. SGOT (AST) and SGPT (ALT) â‰¤ 3.0 x ULN and alkaline phosphatase â‰¤ 2.5 x ULN.\n      4. Neurologic function: Neuropathy (sensory and motor) less than or equal to Grade 1.\n     \n     \n 5.  Patients should be free of active infection requiring parenteral antibiotics or a serious uncontrolled medical illness or disorder within four weeks of study entry.\n 6.  Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to the first treatment. Continuation of hormone replacement therapy is permitted.\n 7.  Patients must have a performance status score of 0, 1 or 2 by Eastern Cooperative Group (ECOG) criteria.\n 8.  Patients of childbearing potential must have a negative serum pregnancy test within 14 days prior to initiation of protocol therapy and be practicing an effective form of contraception. If applicable, patients must discontinue breastfeeding prior to study entry.\n 9.  Patients must have satisfactory results for the baseline laboratory analyses and diagnostic procedures as specified in the protocol.\n 10. Patients must have signed an IRB-approved informed consent and authorization permitting release of personal health information.\n 11. Patients must be at least 18 years old.\n\n","\n\n 1.  Patients who have received prior treatment with GEN-1.\n 2.  History of allergic reactions attributed to compounds of similar chemical or biologic composition to GEN-1 or other agents used in this study.\n 3.  Patients who have received oral or parenteral corticosteroids within 2 weeks of study entry or who have a clinical requirement for ongoing systemic immunosuppressive therapy such as chronic steroid use not related to chemotherapy administration.\n 4.  Patients receiving treatment for active autoimmune disease. \"Active\" refers to any condition currently requiring therapy. Examples of autoimmune disease include systemic lupus erythematosus, multiple sclerosis, inflammatory bowel disease and rheumatoid arthritis.\n 5.  Patients with other invasive malignancies, with the exception of non-melanoma skin cancer and other specific malignancies as noted in the protocol are excluded if there is any evidence of other malignancy being present within the last three years. Patients are also excluded if their previous cancer treatment contraindicates this protocol therapy.\n 6.  Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded. Prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease.\n 7.  Patients who have received prior chemotherapy for any abdominal or pelvic tumor are excluded. Patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease.\n 8.  Patients with known active hepatitis.\n 9.  Patients with concurrent severe medical problems unrelated to the malignancy that would significantly limit full compliance with the study or expose the patient to extreme risk or decreased life expectancy.\n 10. Patients of childbearing potential, not practicing adequate contraception, patients who are pregnant, or patients who are breastfeeding are not eligible for this trial.\n 11. Patients with history or evidence upon physical examination of CNS disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date of treatment on this study.\n 12. Patients with any condition/anomaly that would interfere with the appropriate placement of the IP catheter for study drug administration including: abdominal surgery within 4 weeks of study entry (for reasons other than IP port placement), intestinal dysfunction, or suspected extensive adhesions from prior history or finding at laparoscopy.",{"$nulls":4},"Actual","2018-01-09","Actual","Anticipated","2023-10-31","Anticipated","2018-11-01","2018-01-03","2018-01-03","2018-11-21","Yes",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"Female",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":19},"PFS","The primary objective of the study is to evaluate safety and compare progression free survival between subjects receiving neoadjuvant chemotherapy (NACT) plus GEN-1 versus standard NACT.","The primary analysis for PFS will be conducted after at least 80 events have been observed or after all patients have been followed for at least 16 months, whichever is later.",{"$nulls":6},"Birmingham, Alabama, United States, 35233|Saint Louis, Missouri, United States, 63110|Oklahoma City, Oklahoma, United States, 73104|Pittsburgh, Pennsylvania, United States, 15213|Nashville, Tennessee, United States, 37203|Milwaukee, Wisconsin, United States, 53226","Alabama|Missouri|Oklahoma|Pennsylvania|Tennessee|Wisconsin","United States","University Of Alabama Birmingham|Washington University School Of Medicine In St. Louis|Stephenson Cancer Center - Oklahoma University|University Of Pittsburgh Medical Center|Vanderbilt-Ingram Cancer Center|Medical College Of Wisconsin",{"$nulls":4},"2018-11-21","2020-05-25T16:35:51.412","2020-05-26T17:10:42.972","NCT03393884"]
["5ecbf3e7feab101b1553081f","NCT03393884","2018-12-03","Celsion","CLSN","Recruiting","Study of GEN-1 With NACT for Treatment of Ovarian Cancer (OVATION 2) (OVATION 2)","Carboplatin|Paclitaxel","DNA Synthesis Inhibitor|Mitosis Inhibitor|Tubulin Inhibitor|Tubulin Inhibitor","Unknown",null,"Unknown",null,"Phase 1/Phase 2",2,130,"Anticipated","2018-09-05","2022-02-28","PFS","Progression Free Survival",{"$nulls":3},"This is a randomized, open label, multicenter trial to evaluate the safety, dosing, efficacy and biological activity of intraperitoneal GEN-1 plus NACT compared to NACT alone.",null,"A Phase I/II Study Evaluating the Dosing, Safety, Efficacy, and Biological Activity of Intraperitoneal GEN-1 (IL-12 Plasmid Formulated With PEG-PEI-Cholesterol Lipopolymer) Administered in Combination With Neoadjuvant Chemotherapy (NACT) in Patients Newly Diagnosed With Advanced Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer","201-17-201","Epithelial Ovarian Cancer\nFallopian Tube Cancer\nPrimary Peritoneal Cancer","Fallopian Tube Cancer|Ovarian Cancer","Oncology Solid Tumor","Oncology","Experimental|Active Comparator","NACT + GEN-1|NACT Alone","The NACT regimen will be paclitaxel 175 mg/m2 IV over 3 hours followed by carboplatin AUC 6 IV over 1 hour on Day 1. This will be repeated every 3 weeks for 6 cycles. GEN-1 100 mg/m2 IP will be administered on Days 8 and 15 of the first NACT cycle and then on Days 1, 8, and 15 of the subsequent 21 day NACT cycles for a total of 17 treatments.|The NACT regimen will be paclitaxel 175 mg/m2 IV over 3 hours followed by carboplatin AUC 6 IV over 1 hour on Day 1. This will be repeated every 3 weeks for 6 cycles.","Biological|Drug","GEN-1|Carboplatin|Paclitaxel","IL-12 Plasmid Formulated with PEG-PEI-Cholesterol Lipopolymer|AUC 6 IV over 1 hour on Day 1 of each cycle|175 mg/m2 IV over 3 hours on Day 1 of each cycle",null,"NACT + GEN-1|NACT Alone","\n\n 1.  Patients must have histologic diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal carcinoma per pre-treatment biopsies by laparoscopy, or interventional radiology or CT guided core biopsy. Histologic documentation of the original primary tumor is required via the pathology report.\n 2.  Patients must have an International Federation of Gynecology and Obstetrics (FIGO) of III or IV.\n 3.  Patients with the following histologic epithelial cell types are eligible: High grade serous adenocarcinoma, endometrioid adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, or adenocarcinoma not otherwise specified (N.O.S.).\n 4.  Patients must have adequate: 1. Bone marrow function: Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl. This ANC cannot have been induced or supported by granulocyte colony stimulating factors. Platelets greater than or equal to 100,000/mcl.\n      2. Renal function: Creatinine â‰¤1.5 x institutional upper limit normal (ULN).\n      3. Hepatic function: Bilirubin â‰¤ 1.5 x ULN. SGOT (AST) and SGPT (ALT) â‰¤ 3.0 x ULN and alkaline phosphatase â‰¤ 2.5 x ULN.\n      4. Neurologic function: Neuropathy (sensory and motor) less than or equal to Grade 1.\n     \n     \n 5.  Patients should be free of active infection requiring parenteral antibiotics or a serious uncontrolled medical illness or disorder within four weeks of study entry.\n 6.  Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to the first treatment. Continuation of hormone replacement therapy is permitted.\n 7.  Patients must have a performance status score of 0, 1 or 2 by Eastern Cooperative Group (ECOG) criteria.\n 8.  Patients of childbearing potential must have a negative serum pregnancy test within 14 days prior to initiation of protocol therapy and be practicing an effective form of contraception. If applicable, patients must discontinue breastfeeding prior to study entry.\n 9.  Patients must have satisfactory results for the baseline laboratory analyses and diagnostic procedures as specified in the protocol.\n 10. Patients must have signed an IRB-approved informed consent and authorization permitting release of personal health information.\n 11. Patients must be at least 18 years old.\n\n","\n\n 1.  Patients who have received prior treatment with GEN-1.\n 2.  History of allergic reactions attributed to compounds of similar chemical or biologic composition to GEN-1 or other agents used in this study.\n 3.  Patients who have received oral or parenteral corticosteroids within 2 weeks of study entry or who have a clinical requirement for ongoing systemic immunosuppressive therapy such as chronic steroid use not related to chemotherapy administration.\n 4.  Patients receiving treatment for active autoimmune disease. \"Active\" refers to any condition currently requiring therapy. Examples of autoimmune disease include systemic lupus erythematosus, multiple sclerosis, inflammatory bowel disease and rheumatoid arthritis.\n 5.  Patients with other invasive malignancies, with the exception of non-melanoma skin cancer and other specific malignancies as noted in the protocol are excluded if there is any evidence of other malignancy being present within the last three years. Patients are also excluded if their previous cancer treatment contraindicates this protocol therapy.\n 6.  Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded. Prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease.\n 7.  Patients who have received prior chemotherapy for any abdominal or pelvic tumor are excluded. Patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease.\n 8.  Patients with known active hepatitis.\n 9.  Patients with concurrent severe medical problems unrelated to the malignancy that would significantly limit full compliance with the study or expose the patient to extreme risk or decreased life expectancy.\n 10. Patients of childbearing potential, not practicing adequate contraception, patients who are pregnant, or patients who are breastfeeding are not eligible for this trial.\n 11. Patients with history or evidence upon physical examination of CNS disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date of treatment on this study.\n 12. Patients with any condition/anomaly that would interfere with the appropriate placement of the IP catheter for study drug administration including: abdominal surgery within 4 weeks of study entry (for reasons other than IP port placement), intestinal dysfunction, or suspected extensive adhesions from prior history or finding at laparoscopy.",{"$nulls":4},"Actual","2018-01-09","Actual","Anticipated","2023-10-31","Anticipated","2018-11-01","2018-01-03","2018-01-03","2018-11-29","Yes",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"Female",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":19},"PFS","The primary objective of the study is to evaluate safety and compare progression free survival between subjects receiving neoadjuvant chemotherapy (NACT) plus GEN-1 versus standard NACT.","The primary analysis for PFS will be conducted after at least 80 events have been observed or after all patients have been followed for at least 16 months, whichever is later.",{"$nulls":6},"Birmingham, Alabama, United States, 35233|Saint Louis, Missouri, United States, 63110|Oklahoma City, Oklahoma, United States, 73104|Pittsburgh, Pennsylvania, United States, 15213|Nashville, Tennessee, United States, 37203|Milwaukee, Wisconsin, United States, 53226","Alabama|Missouri|Oklahoma|Pennsylvania|Tennessee|Wisconsin","United States","University Of Alabama Birmingham|Washington University School Of Medicine In St. Louis|Stephenson Cancer Center - Oklahoma University|University Of Pittsburgh Medical Center|Vanderbilt-Ingram Cancer Center|Medical College Of Wisconsin",{"$nulls":4},"2018-11-29","2020-05-25T16:35:51.327","2020-05-26T17:10:42.972","NCT03393884"]
["5ecbf3e7307e3d1b1f8d9c80","NCT03393884","2019-02-06","Celsion","CLSN","Recruiting","Study of GEN-1 With NACT for Treatment of Ovarian Cancer (OVATION 2) (OVATION 2)","Carboplatin|Paclitaxel","DNA Synthesis Inhibitor|Mitosis Inhibitor|Tubulin Inhibitor|Tubulin Inhibitor","Unknown",null,"Unknown",null,"Phase 1/Phase 2",2,130,"Anticipated","2018-09-05","2022-02-28","PFS","Progression Free Survival",{"$nulls":3},"This is a randomized, open label, multicenter trial to evaluate the safety, dosing, efficacy and biological activity of intraperitoneal GEN-1 plus NACT compared to NACT alone.",null,"A Phase I/II Study Evaluating the Dosing, Safety, Efficacy, and Biological Activity of Intraperitoneal GEN-1 (IL-12 Plasmid Formulated With PEG-PEI-Cholesterol Lipopolymer) Administered in Combination With Neoadjuvant Chemotherapy (NACT) in Patients Newly Diagnosed With Advanced Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer","201-17-201","Epithelial Ovarian Cancer\nFallopian Tube Cancer\nPrimary Peritoneal Cancer","Fallopian Tube Cancer|Ovarian Cancer","Oncology Solid Tumor","Oncology","Experimental|Active Comparator","NACT + GEN-1|NACT Alone","The NACT regimen will be paclitaxel 175 mg/m2 IV over 3 hours followed by carboplatin AUC 6 IV over 1 hour on Day 1. This will be repeated every 3 weeks for 6 cycles. GEN-1 100 mg/m2 IP will be administered on Days 8 and 15 of the first NACT cycle and then on Days 1, 8, and 15 of the subsequent 21 day NACT cycles for a total of 17 treatments.|The NACT regimen will be paclitaxel 175 mg/m2 IV over 3 hours followed by carboplatin AUC 6 IV over 1 hour on Day 1. This will be repeated every 3 weeks for 6 cycles.","Biological|Drug","GEN-1|Carboplatin|Paclitaxel","IL-12 Plasmid Formulated with PEG-PEI-Cholesterol Lipopolymer|AUC 6 IV over 1 hour on Day 1 of each cycle|175 mg/m2 IV over 3 hours on Day 1 of each cycle",null,"NACT + GEN-1|NACT Alone","\n\n 1.  Patients must have histologic diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal carcinoma per pre-treatment biopsies by laparoscopy, or interventional radiology or CT guided core biopsy. Histologic documentation of the original primary tumor is required via the pathology report.\n 2.  Patients must have an International Federation of Gynecology and Obstetrics (FIGO) of III or IV.\n 3.  Patients with the following histologic epithelial cell types are eligible: High grade serous adenocarcinoma, endometrioid adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, or adenocarcinoma not otherwise specified (N.O.S.).\n 4.  Patients must have adequate: 1. Bone marrow function: Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl. This ANC cannot have been induced or supported by granulocyte colony stimulating factors. Platelets greater than or equal to 100,000/mcl.\n      2. Renal function: Creatinine â‰¤1.5 x institutional upper limit normal (ULN).\n      3. Hepatic function: Bilirubin â‰¤ 1.5 x ULN. SGOT (AST) and SGPT (ALT) â‰¤ 3.0 x ULN and alkaline phosphatase â‰¤ 2.5 x ULN.\n      4. Neurologic function: Neuropathy (sensory and motor) less than or equal to Grade 1.\n     \n     \n 5.  Patients should be free of active infection requiring parenteral antibiotics or a serious uncontrolled medical illness or disorder within four weeks of study entry.\n 6.  Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to the first treatment. Continuation of hormone replacement therapy is permitted.\n 7.  Patients must have a performance status score of 0, 1 or 2 by Eastern Cooperative Group (ECOG) criteria.\n 8.  Patients of childbearing potential must have a negative serum pregnancy test within 14 days prior to initiation of protocol therapy and be practicing an effective form of contraception. If applicable, patients must discontinue breastfeeding prior to study entry.\n 9.  Patients must have satisfactory results for the baseline laboratory analyses and diagnostic procedures as specified in the protocol.\n 10. Patients must have signed an IRB-approved informed consent and authorization permitting release of personal health information.\n 11. Patients must be at least 18 years old.\n\n","\n\n 1.  Patients who have received prior treatment with GEN-1.\n 2.  History of allergic reactions attributed to compounds of similar chemical or biologic composition to GEN-1 or other agents used in this study.\n 3.  Patients who have received oral or parenteral corticosteroids within 2 weeks of study entry or who have a clinical requirement for ongoing systemic immunosuppressive therapy such as chronic steroid use not related to chemotherapy administration.\n 4.  Patients receiving treatment for active autoimmune disease. \"Active\" refers to any condition currently requiring therapy. Examples of autoimmune disease include systemic lupus erythematosus, multiple sclerosis, inflammatory bowel disease and rheumatoid arthritis.\n 5.  Patients with other invasive malignancies, with the exception of non-melanoma skin cancer and other specific malignancies as noted in the protocol are excluded if there is any evidence of other malignancy being present within the last three years. Patients are also excluded if their previous cancer treatment contraindicates this protocol therapy.\n 6.  Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded. Prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease.\n 7.  Patients who have received prior chemotherapy for any abdominal or pelvic tumor are excluded. Patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease.\n 8.  Patients with known active hepatitis.\n 9.  Patients with concurrent severe medical problems unrelated to the malignancy that would significantly limit full compliance with the study or expose the patient to extreme risk or decreased life expectancy.\n 10. Patients of childbearing potential, not practicing adequate contraception, patients who are pregnant, or patients who are breastfeeding are not eligible for this trial.\n 11. Patients with history or evidence upon physical examination of CNS disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date of treatment on this study.\n 12. Patients with any condition/anomaly that would interfere with the appropriate placement of the IP catheter for study drug administration including: abdominal surgery within 4 weeks of study entry (for reasons other than IP port placement), intestinal dysfunction, or suspected extensive adhesions from prior history or finding at laparoscopy.",{"$nulls":4},"Actual","2018-01-09","Actual","Anticipated","2023-10-31","Anticipated","2019-02-01","2018-01-03","2018-01-03","2019-02-05","Yes",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"Female",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":19},"PFS","The primary objective of the study is to evaluate safety and compare progression free survival between subjects receiving neoadjuvant chemotherapy (NACT) plus GEN-1 versus standard NACT.","The primary analysis for PFS will be conducted after at least 80 events have been observed or after all patients have been followed for at least 16 months, whichever is later.",{"$nulls":6},"Birmingham, Alabama, United States, 35233|Newport Beach, California, United States, 92663|Orlando, Florida, United States, 32803|Boston, Massachusetts, United States, 02114|Saint Louis, Missouri, United States, 63110|Hackensack, New Jersey, United States, 07601|Oklahoma City, Oklahoma, United States, 73104|Pittsburgh, Pennsylvania, United States, 15213|Providence, Rhode Island, United States, 02905|Charleston, South Carolina, United States, 29425|Sioux Falls, South Dakota, United States, 57104|Chattanooga, Tennessee, United States, 37403|Milwaukee, Wisconsin, United States, 53226","Alabama|California|Florida|Massachusetts|Missouri|New Jersey|Oklahoma|Pennsylvania|Rhode Island|South Carolina|South Dakota|Tennessee|Wisconsin","United States","University Of Alabama Birmingham|Gynecologic Oncology Associates - Women's Cancer Research Foundation|Advent Health|Massachusetts General Hospital|Washington University School Of Medicine In St. Louis|Hackensack University Medical Center|Stephenson Cancer Center - Oklahoma University|University Of Pittsburgh Medical Center|Wpmen & Infants Hopsital Of Rhode Island|Medican University Of South Carolina|Sanford Health|Chattanooga Women's Health|Medical College Of Wisconsin",{"$nulls":4},"2019-02-05","2020-05-25T16:35:51.346","2020-05-26T17:10:42.972","NCT03393884"]
["5ecbf3e7e2561b1b11905ceb","NCT03393884","2019-04-01","Celsion","CLSN","Recruiting","Study of GEN-1 With NACT for Treatment of Ovarian Cancer (OVATION 2) (OVATION 2)","Carboplatin|Paclitaxel","DNA Synthesis Inhibitor|Mitosis Inhibitor|Tubulin Inhibitor|Tubulin Inhibitor","Unknown",null,"Unknown",null,"Phase 1/Phase 2",2,130,"Anticipated","2018-09-05","2022-02-28","PFS","Progression Free Survival",{"$nulls":3},"This is a randomized, open label, multicenter trial to evaluate the safety, dosing, efficacy and biological activity of intraperitoneal GEN-1 plus NACT compared to NACT alone.",null,"A Phase I/II Study Evaluating the Dosing, Safety, Efficacy, and Biological Activity of Intraperitoneal GEN-1 (IL-12 Plasmid Formulated With PEG-PEI-Cholesterol Lipopolymer) Administered in Combination With Neoadjuvant Chemotherapy (NACT) in Patients Newly Diagnosed With Advanced Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer","201-17-201","Epithelial Ovarian Cancer\nFallopian Tube Cancer\nPrimary Peritoneal Cancer","Fallopian Tube Cancer|Ovarian Cancer","Oncology Solid Tumor","Oncology","Experimental|Active Comparator","NACT + GEN-1|NACT Alone","The NACT regimen will be paclitaxel 175 mg/m2 IV over 3 hours followed by carboplatin AUC 6 IV over 1 hour on Day 1. This will be repeated every 3 weeks for 6 cycles. GEN-1 100 mg/m2 IP will be administered on Days 8 and 15 of the first NACT cycle and then on Days 1, 8, and 15 of the subsequent 21 day NACT cycles for a total of 17 treatments.|The NACT regimen will be paclitaxel 175 mg/m2 IV over 3 hours followed by carboplatin AUC 6 IV over 1 hour on Day 1. This will be repeated every 3 weeks for 6 cycles.","Biological|Drug","GEN-1|Carboplatin|Paclitaxel","IL-12 Plasmid Formulated with PEG-PEI-Cholesterol Lipopolymer|AUC 6 IV over 1 hour on Day 1 of each cycle|175 mg/m2 IV over 3 hours on Day 1 of each cycle",null,"NACT + GEN-1|NACT Alone","\n\n 1.  Patients must have histologic diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal carcinoma per pre-treatment biopsies by laparoscopy, or interventional radiology or CT guided core biopsy. Histologic documentation of the original primary tumor is required via the pathology report.\n 2.  Patients must have an International Federation of Gynecology and Obstetrics (FIGO) of III or IV.\n 3.  Patients with the following histologic epithelial cell types are eligible: High grade serous adenocarcinoma, endometrioid adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, or adenocarcinoma not otherwise specified (N.O.S.).\n 4.  Patients must have adequate: 1. Bone marrow function: Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl. This ANC cannot have been induced or supported by granulocyte colony stimulating factors. Platelets greater than or equal to 100,000/mcl.\n      2. Renal function: Creatinine â‰¤1.5 x institutional upper limit normal (ULN).\n      3. Hepatic function: Bilirubin â‰¤ 1.5 x ULN. SGOT (AST) and SGPT (ALT) â‰¤ 3.0 x ULN and alkaline phosphatase â‰¤ 2.5 x ULN.\n      4. Neurologic function: Neuropathy (sensory and motor) less than or equal to Grade 1.\n     \n     \n 5.  Patients should be free of active infection requiring parenteral antibiotics or a serious uncontrolled medical illness or disorder within four weeks of study entry.\n 6.  Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to the first treatment. Continuation of hormone replacement therapy is permitted.\n 7.  Patients must have a performance status score of 0, 1 or 2 by Eastern Cooperative Group (ECOG) criteria.\n 8.  Patients of childbearing potential must have a negative serum pregnancy test within 14 days prior to initiation of protocol therapy and be practicing an effective form of contraception. If applicable, patients must discontinue breastfeeding prior to study entry.\n 9.  Patients must have satisfactory results for the baseline laboratory analyses and diagnostic procedures as specified in the protocol.\n 10. Patients must have signed an IRB-approved informed consent and authorization permitting release of personal health information.\n 11. Patients must be at least 18 years old.\n\n","\n\n 1.  Patients who have received prior treatment with GEN-1.\n 2.  History of allergic reactions attributed to compounds of similar chemical or biologic composition to GEN-1 or other agents used in this study.\n 3.  Patients who have received oral or parenteral corticosteroids within 2 weeks of study entry or who have a clinical requirement for ongoing systemic immunosuppressive therapy such as chronic steroid use not related to chemotherapy administration.\n 4.  Patients receiving treatment for active autoimmune disease. \"Active\" refers to any condition currently requiring therapy. Examples of autoimmune disease include systemic lupus erythematosus, multiple sclerosis, inflammatory bowel disease and rheumatoid arthritis.\n 5.  Patients with other invasive malignancies, with the exception of non-melanoma skin cancer and other specific malignancies as noted in the protocol are excluded if there is any evidence of other malignancy being present within the last three years. Patients are also excluded if their previous cancer treatment contraindicates this protocol therapy.\n 6.  Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded. Prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease.\n 7.  Patients who have received prior chemotherapy for any abdominal or pelvic tumor are excluded. Patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease.\n 8.  Patients with known active hepatitis.\n 9.  Patients with concurrent severe medical problems unrelated to the malignancy that would significantly limit full compliance with the study or expose the patient to extreme risk or decreased life expectancy.\n 10. Patients of childbearing potential, not practicing adequate contraception, patients who are pregnant, or patients who are breastfeeding are not eligible for this trial.\n 11. Patients with history or evidence upon physical examination of CNS disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date of treatment on this study.\n 12. Patients with any condition/anomaly that would interfere with the appropriate placement of the IP catheter for study drug administration including: abdominal surgery within 4 weeks of study entry (for reasons other than IP port placement), intestinal dysfunction, or suspected extensive adhesions from prior history or finding at laparoscopy.",{"$nulls":4},"Actual","2018-01-09","Actual","Anticipated","2023-10-31","Anticipated","2019-03-01","2018-01-03","2018-01-03","2019-03-28","Yes",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"Female",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":19},"PFS","The primary objective of the study is to evaluate safety and compare progression free survival between subjects receiving neoadjuvant chemotherapy (NACT) plus GEN-1 versus standard NACT.","The primary analysis for PFS will be conducted after at least 80 events have been observed or after all patients have been followed for at least 16 months, whichever is later.",{"$nulls":6},"Birmingham, Alabama, United States, 35233|Newport Beach, California, United States, 92663 Innovative Clinical ResearchWhittier, California, United States, 90603|Orlando, Florida, United States, 32803|Boston, Massachusetts, United States, 02114|Saint Louis, Missouri, United States, 63110|Camden, New Jersey, United States, 08105|Lake Success, New York, United States, 11042|Oklahoma City, Oklahoma, United States, 73104|Pittsburgh, Pennsylvania, United States, 15213|Providence, Rhode Island, United States, 02905|Charleston, South Carolina, United States, 29425|Sioux Falls, South Dakota, United States, 57104|Chattanooga, Tennessee, United States, 37403|Milwaukee, Wisconsin, United States, 53226","Alabama|California|Florida|Massachusetts|Missouri|New Jersey|New York|Oklahoma|Pennsylvania|Rhode Island|South Carolina|South Dakota|Tennessee|Wisconsin","United States","University Of Alabama Birmingham|Gynecologic Oncology Associates - Women's Cancer Research Foundation|Advent Health|Massachusetts General Hospital|Washington University School Of Medicine In St. Louis|Cooper Health (Md Anderson)|Monter Cancer Center|Stephenson Cancer Center - Oklahoma University|University Of Pittsburgh Medical Center|Women & Infants Hopsital Of Rhode Island|Medical University Of South Carolina|Sanford Health|Chattanooga Women's Health|Medical College Of Wisconsin",{"$nulls":4},"2019-03-28","2020-05-25T16:35:51.365","2020-05-26T17:10:42.972","NCT03393884"]
["5ecbf3e7307e3d1b1f8d9c81","NCT03393884","2019-04-29","Celsion","CLSN","Recruiting","Study of GEN-1 With NACT for Treatment of Ovarian Cancer (OVATION 2) (OVATION 2)","Carboplatin|Paclitaxel","DNA Synthesis Inhibitor|Mitosis Inhibitor|Tubulin Inhibitor|Tubulin Inhibitor","Unknown",null,"Unknown",null,"Phase 1/Phase 2",2,130,"Anticipated","2018-09-05","2022-02-28","PFS","Progression Free Survival",{"$nulls":3},"This is a randomized, open label, multicenter trial to evaluate the safety, dosing, efficacy and biological activity of intraperitoneal GEN-1 plus NACT compared to NACT alone.",null,"A Phase I/II Study Evaluating the Dosing, Safety, Efficacy, and Biological Activity of Intraperitoneal GEN-1 (IL-12 Plasmid Formulated With PEG-PEI-Cholesterol Lipopolymer) Administered in Combination With Neoadjuvant Chemotherapy (NACT) in Patients Newly Diagnosed With Advanced Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer","201-17-201","Epithelial Ovarian Cancer\nFallopian Tube Cancer\nPrimary Peritoneal Cancer","Fallopian Tube Cancer|Ovarian Cancer","Oncology Solid Tumor","Oncology","Experimental|Active Comparator","NACT + GEN-1|NACT Alone","The NACT regimen will be paclitaxel 175 mg/m2 IV over 3 hours followed by carboplatin AUC 6 IV over 1 hour on Day 1. This will be repeated every 3 weeks for 6 cycles. GEN-1 100 mg/m2 IP will be administered on Days 8 and 15 of the first NACT cycle and then on Days 1, 8, and 15 of the subsequent 21 day NACT cycles for a total of 17 treatments.|The NACT regimen will be paclitaxel 175 mg/m2 IV over 3 hours followed by carboplatin AUC 6 IV over 1 hour on Day 1. This will be repeated every 3 weeks for 6 cycles.","Biological|Drug","GEN-1|Carboplatin|Paclitaxel","IL-12 Plasmid Formulated with PEG-PEI-Cholesterol Lipopolymer|AUC 6 IV over 1 hour on Day 1 of each cycle|175 mg/m2 IV over 3 hours on Day 1 of each cycle",null,"NACT + GEN-1|NACT Alone","\n\n 1.  Patients must have histologic diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal carcinoma per pre-treatment biopsies by laparoscopy, or interventional radiology or CT guided core biopsy. Histologic documentation of the original primary tumor is required via the pathology report.\n 2.  Patients must have an International Federation of Gynecology and Obstetrics (FIGO) of III or IV.\n 3.  Patients with the following histologic epithelial cell types are eligible: High grade serous adenocarcinoma, endometrioid adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, or adenocarcinoma not otherwise specified (N.O.S.).\n 4.  Patients must have adequate: 1. Bone marrow function: Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl. This ANC cannot have been induced or supported by granulocyte colony stimulating factors. Platelets greater than or equal to 100,000/mcl.\n      2. Renal function: Creatinine â‰¤1.5 x institutional upper limit normal (ULN).\n      3. Hepatic function: Bilirubin â‰¤ 1.5 x ULN. SGOT (AST) and SGPT (ALT) â‰¤ 3.0 x ULN and alkaline phosphatase â‰¤ 2.5 x ULN.\n      4. Neurologic function: Neuropathy (sensory and motor) less than or equal to Grade 1.\n     \n     \n 5.  Patients should be free of active infection requiring parenteral antibiotics or a serious uncontrolled medical illness or disorder within four weeks of study entry.\n 6.  Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to the first treatment. Continuation of hormone replacement therapy is permitted.\n 7.  Patients must have a performance status score of 0, 1 or 2 by Eastern Cooperative Group (ECOG) criteria.\n 8.  Patients of childbearing potential must have a negative serum pregnancy test within 14 days prior to initiation of protocol therapy and be practicing an effective form of contraception. If applicable, patients must discontinue breastfeeding prior to study entry.\n 9.  Patients must have satisfactory results for the baseline laboratory analyses and diagnostic procedures as specified in the protocol.\n 10. Patients must have signed an IRB-approved informed consent and authorization permitting release of personal health information.\n 11. Patients must be at least 18 years old.\n\n","\n\n 1.  Patients who have received prior treatment with GEN-1.\n 2.  History of allergic reactions attributed to compounds of similar chemical or biologic composition to GEN-1 or other agents used in this study.\n 3.  Patients who have received oral or parenteral corticosteroids within 2 weeks of study entry or who have a clinical requirement for ongoing systemic immunosuppressive therapy such as chronic steroid use not related to chemotherapy administration.\n 4.  Patients receiving treatment for active autoimmune disease. \"Active\" refers to any condition currently requiring therapy. Examples of autoimmune disease include systemic lupus erythematosus, multiple sclerosis, inflammatory bowel disease and rheumatoid arthritis.\n 5.  Patients with other invasive malignancies, with the exception of non-melanoma skin cancer and other specific malignancies as noted in the protocol are excluded if there is any evidence of other malignancy being present within the last three years. Patients are also excluded if their previous cancer treatment contraindicates this protocol therapy.\n 6.  Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded. Prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease.\n 7.  Patients who have received prior chemotherapy for any abdominal or pelvic tumor are excluded. Patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease.\n 8.  Patients with known active hepatitis.\n 9.  Patients with concurrent severe medical problems unrelated to the malignancy that would significantly limit full compliance with the study or expose the patient to extreme risk or decreased life expectancy.\n 10. Patients of childbearing potential, not practicing adequate contraception, patients who are pregnant, or patients who are breastfeeding are not eligible for this trial.\n 11. Patients with history or evidence upon physical examination of CNS disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date of treatment on this study.\n 12. Patients with any condition/anomaly that would interfere with the appropriate placement of the IP catheter for study drug administration including: abdominal surgery within 4 weeks of study entry (for reasons other than IP port placement), intestinal dysfunction, or suspected extensive adhesions from prior history or finding at laparoscopy.",{"$nulls":4},"Actual","2018-01-09","Actual","Anticipated","2023-10-31","Anticipated","2019-04-01","2018-01-03","2018-01-03","2019-04-26","Yes",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"Female",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":19},"PFS","The primary objective of the study is to evaluate safety and compare progression free survival between subjects receiving neoadjuvant chemotherapy (NACT) plus GEN-1 versus standard NACT.","The primary analysis for PFS will be conducted after at least 80 events have been observed or after all patients have been followed for at least 16 months, whichever is later.",{"$nulls":6},"Augusta, Georgia, United States, 30912|Gainesville, Georgia, United States, 30501|Birmingham, Alabama, United States, 35233|La Jolla, California, United States, 92093-0698|Miramar, Florida, United States, 33027|Boston, Massachusetts, United States, 02114|Saint Louis, Missouri, United States, 63110|Billings, Montana, United States, 59101|Camden, New Jersey, United States, 08105|Lake Success, New York, United States, 11042|Winston-Salem, North Carolina, United States, 27101|Cleveland, Ohio, United States, 44195|Oklahoma City, Oklahoma, United States, 73104|Pittsburgh, Pennsylvania, United States, 15213 West Penn Hospital Of Allegheny Health NetworkPittsburgh, Pennsylvania, United States, 15224|Providence, Rhode Island, United States, 02905|Charleston, South Carolina, United States, 29425|Sioux Falls, South Dakota, United States, 57104|Chattanooga, Tennessee, United States, 37403|Milwaukee, Wisconsin, United States, 53226","Alabama|California|Florida|Massachusetts|Missouri|Montana|New Jersey|New York|North Carolina|Ohio|Oklahoma|Pennsylvania|Rhode Island|South Carolina|South Dakota|Tennessee|Wisconsin","Georgia|United States","Cancer Center At Augusta University|Medical Center|University Of Alabama Birmingham|University Of California - San Diego|The Center For Gynecologic Oncology|Massachusetts General Hospital|Washington University School Of Medicine In St. Louis|Billings Clinic|Cooper Health (Md Anderson)|Monter Cancer Center|Wake Forest School Of Medicine|Cleveland Clinic|Stephenson Cancer Center - Oklahoma University|University Of Pittsburgh Medical Center|Women & Infants Hopsital Of Rhode Island|Medical University Of South Carolina|Sanford Health|Chattanooga Women's Health|Medical College Of Wisconsin",{"$nulls":4},"2019-04-26","2020-05-25T16:35:51.484","2020-05-26T17:10:42.972","NCT03393884"]
["5ecbf3e711702c1b1b916a02","NCT03393884","2019-05-10","Celsion","CLSN","Recruiting","Study of GEN-1 With NACT for Treatment of Ovarian Cancer (OVATION 2) (OVATION 2)","Carboplatin|Paclitaxel","DNA Synthesis Inhibitor|Mitosis Inhibitor|Tubulin Inhibitor|Tubulin Inhibitor","Unknown",null,"Unknown",null,"Phase 1/Phase 2",2,130,"Anticipated","2018-09-05","2022-02-28","PFS","Progression Free Survival",{"$nulls":3},"This is a randomized, open label, multicenter trial to evaluate the safety, dosing, efficacy and biological activity of intraperitoneal GEN-1 plus NACT compared to NACT alone.",null,"A Phase I/II Study Evaluating the Dosing, Safety, Efficacy, and Biological Activity of Intraperitoneal GEN-1 (IL-12 Plasmid Formulated With PEG-PEI-Cholesterol Lipopolymer) Administered in Combination With Neoadjuvant Chemotherapy (NACT) in Patients Newly Diagnosed With Advanced Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer","201-17-201","Epithelial Ovarian Cancer\nFallopian Tube Cancer\nPrimary Peritoneal Cancer","Fallopian Tube Cancer|Ovarian Cancer","Oncology Solid Tumor","Oncology","Experimental|Active Comparator","NACT + GEN-1|NACT Alone","The NACT regimen will be paclitaxel 175 mg/m2 IV over 3 hours followed by carboplatin AUC 6 IV over 1 hour on Day 1. This will be repeated every 3 weeks for 6 cycles. GEN-1 100 mg/m2 IP will be administered on Days 8 and 15 of the first NACT cycle and then on Days 1, 8, and 15 of the subsequent 21 day NACT cycles for a total of 17 treatments.|The NACT regimen will be paclitaxel 175 mg/m2 IV over 3 hours followed by carboplatin AUC 6 IV over 1 hour on Day 1. This will be repeated every 3 weeks for 6 cycles.","Biological|Drug","GEN-1|Carboplatin|Paclitaxel","IL-12 Plasmid Formulated with PEG-PEI-Cholesterol Lipopolymer|AUC 6 IV over 1 hour on Day 1 of each cycle|175 mg/m2 IV over 3 hours on Day 1 of each cycle",null,"NACT + GEN-1|NACT Alone","\n\n 1.  Patients must have histologic diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal carcinoma per pre-treatment biopsies by laparoscopy, or interventional radiology or CT guided core biopsy. Histologic documentation of the original primary tumor is required via the pathology report.\n 2.  Patients must have an International Federation of Gynecology and Obstetrics (FIGO) of III or IV.\n 3.  Patients with the following histologic epithelial cell types are eligible: High grade serous adenocarcinoma, endometrioid adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, or adenocarcinoma not otherwise specified (N.O.S.).\n 4.  Patients must have adequate: 1. Bone marrow function: Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl. This ANC cannot have been induced or supported by granulocyte colony stimulating factors. Platelets greater than or equal to 100,000/mcl.\n      2. Renal function: Creatinine â‰¤1.5 x institutional upper limit normal (ULN).\n      3. Hepatic function: Bilirubin â‰¤ 1.5 x ULN. SGOT (AST) and SGPT (ALT) â‰¤ 3.0 x ULN and alkaline phosphatase â‰¤ 2.5 x ULN.\n      4. Neurologic function: Neuropathy (sensory and motor) less than or equal to Grade 1.\n     \n     \n 5.  Patients should be free of active infection requiring parenteral antibiotics or a serious uncontrolled medical illness or disorder within four weeks of study entry.\n 6.  Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to the first treatment. Continuation of hormone replacement therapy is permitted.\n 7.  Patients must have a performance status score of 0, 1 or 2 by Eastern Cooperative Group (ECOG) criteria.\n 8.  Patients of childbearing potential must have a negative serum pregnancy test within 14 days prior to initiation of protocol therapy and be practicing an effective form of contraception. If applicable, patients must discontinue breastfeeding prior to study entry.\n 9.  Patients must have satisfactory results for the baseline laboratory analyses and diagnostic procedures as specified in the protocol.\n 10. Patients must have signed an IRB-approved informed consent and authorization permitting release of personal health information.\n 11. Patients must be at least 18 years old.\n\n","\n\n 1.  Patients who have received prior treatment with GEN-1.\n 2.  History of allergic reactions attributed to compounds of similar chemical or biologic composition to GEN-1 or other agents used in this study.\n 3.  Patients who have received oral or parenteral corticosteroids within 2 weeks of study entry or who have a clinical requirement for ongoing systemic immunosuppressive therapy such as chronic steroid use not related to chemotherapy administration.\n 4.  Patients receiving treatment for active autoimmune disease. \"Active\" refers to any condition currently requiring therapy. Examples of autoimmune disease include systemic lupus erythematosus, multiple sclerosis, inflammatory bowel disease and rheumatoid arthritis.\n 5.  Patients with other invasive malignancies, with the exception of non-melanoma skin cancer and other specific malignancies as noted in the protocol are excluded if there is any evidence of other malignancy being present within the last three years. Patients are also excluded if their previous cancer treatment contraindicates this protocol therapy.\n 6.  Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded. Prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease.\n 7.  Patients who have received prior chemotherapy for any abdominal or pelvic tumor are excluded. Patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease.\n 8.  Patients with known active hepatitis.\n 9.  Patients with concurrent severe medical problems unrelated to the malignancy that would significantly limit full compliance with the study or expose the patient to extreme risk or decreased life expectancy.\n 10. Patients of childbearing potential, not practicing adequate contraception, patients who are pregnant, or patients who are breastfeeding are not eligible for this trial.\n 11. Patients with history or evidence upon physical examination of CNS disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date of treatment on this study.\n 12. Patients with any condition/anomaly that would interfere with the appropriate placement of the IP catheter for study drug administration including: abdominal surgery within 4 weeks of study entry (for reasons other than IP port placement), intestinal dysfunction, or suspected extensive adhesions from prior history or finding at laparoscopy.",{"$nulls":4},"Actual","2018-01-09","Actual","Anticipated","2023-10-31","Anticipated","2019-05-01","2018-01-03","2018-01-03","2019-05-09","Yes",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"Female",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":19},"PFS","The primary objective of the study is to evaluate safety and compare progression free survival between subjects receiving neoadjuvant chemotherapy (NACT) plus GEN-1 versus standard NACT.","The primary analysis for PFS will be conducted after at least 80 events have been observed or after all patients have been followed for at least 16 months, whichever is later.",{"$nulls":6},"Augusta, Georgia, United States, 30912 Northeast|Gainesville, Georgia, United States, 30501|Birmingham, Alabama, United States, 35233|La Jolla, California, United States, 92093-0698|Miramar, Florida, United States, 33027|Boston, Massachusetts, United States, 02114|Saint Louis, Missouri, United States, 63110|Billings, Montana, United States, 59101|Camden, New Jersey, United States, 08105|Lake Success, New York, United States, 11042|Winston-Salem, North Carolina, United States, 27101|Cleveland, Ohio, United States, 44195|Oklahoma City, Oklahoma, United States, 73104|Pittsburgh, Pennsylvania, United States, 15213 West Penn Hospital Of Allegheny Health NetworkPittsburgh, Pennsylvania, United States, 15224|Providence, Rhode Island, United States, 02905|Charleston, South Carolina, United States, 29425|Sioux Falls, South Dakota, United States, 57104|Chattanooga, Tennessee, United States, 37403|Milwaukee, Wisconsin, United States, 53226","Alabama|California|Florida|Massachusetts|Missouri|Montana|New Jersey|New York|North Carolina|Ohio|Oklahoma|Pennsylvania|Rhode Island|South Carolina|South Dakota|Tennessee|Wisconsin","Georgia|United States","Cancer Center At Augusta University|Medical Center|University Of Alabama Birmingham|University Of California - San Diego|The Center For Gynecologic Oncology|Massachusetts General Hospital|Washington University School Of Medicine In St. Louis|Billings Clinic|Cooper Health (Md Anderson)|Monter Cancer Center|Wake Forest School Of Medicine|Cleveland Clinic|Stephenson Cancer Center - Oklahoma University|University Of Pittsburgh Medical Center|Women & Infants Hopsital Of Rhode Island|Medical University Of South Carolina|Sanford Health|Chattanooga Women's Health|Medical College Of Wisconsin",{"$nulls":4},"2019-05-09","2020-05-25T16:35:51.451","2020-05-26T17:10:42.972","NCT03393884"]
["5ecbf3e7feab101b15530821","NCT03393884","2019-06-03","Celsion","CLSN","Recruiting","Study of GEN-1 With NACT for Treatment of Ovarian Cancer (OVATION 2) (OVATION 2)","Carboplatin|Paclitaxel","DNA Synthesis Inhibitor|Mitosis Inhibitor|Tubulin Inhibitor|Tubulin Inhibitor","Unknown",null,"Unknown",null,"Phase 1/Phase 2",2,130,"Anticipated","2018-09-05","2022-02-28","PFS","Progression Free Survival",{"$nulls":3},"This is a randomized, open label, multicenter trial to evaluate the safety, dosing, efficacy and biological activity of intraperitoneal GEN-1 plus NACT compared to NACT alone.",null,"A Phase I/II Study Evaluating the Dosing, Safety, Efficacy, and Biological Activity of Intraperitoneal GEN-1 (IL-12 Plasmid Formulated With PEG-PEI-Cholesterol Lipopolymer) Administered in Combination With Neoadjuvant Chemotherapy (NACT) in Patients Newly Diagnosed With Advanced Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer","201-17-201","Epithelial Ovarian Cancer\nFallopian Tube Cancer\nPrimary Peritoneal Cancer","Fallopian Tube Cancer|Ovarian Cancer","Oncology Solid Tumor","Oncology","Experimental|Active Comparator","NACT + GEN-1|NACT Alone","The NACT regimen will be paclitaxel 175 mg/m2 IV over 3 hours followed by carboplatin AUC 6 IV over 1 hour on Day 1. This will be repeated every 3 weeks for 6 cycles. GEN-1 100 mg/m2 IP will be administered on Days 8 and 15 of the first NACT cycle and then on Days 1, 8, and 15 of the subsequent 21 day NACT cycles for a total of 17 treatments.|The NACT regimen will be paclitaxel 175 mg/m2 IV over 3 hours followed by carboplatin AUC 6 IV over 1 hour on Day 1. This will be repeated every 3 weeks for 6 cycles.","Biological|Drug","GEN-1|Carboplatin|Paclitaxel","IL-12 Plasmid Formulated with PEG-PEI-Cholesterol Lipopolymer|AUC 6 IV over 1 hour on Day 1 of each cycle|175 mg/m2 IV over 3 hours on Day 1 of each cycle",null,"NACT + GEN-1|NACT Alone","\n\n 1.  Patients must have histologic diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal carcinoma per pre-treatment biopsies by laparoscopy, or interventional radiology or CT guided core biopsy. Histologic documentation of the original primary tumor is required via the pathology report.\n 2.  Patients must have an International Federation of Gynecology and Obstetrics (FIGO) of III or IV.\n 3.  Patients with the following histologic epithelial cell types are eligible: High grade serous adenocarcinoma, endometrioid adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, or adenocarcinoma not otherwise specified (N.O.S.).\n 4.  Patients must have adequate: 1. Bone marrow function: Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl. This ANC cannot have been induced or supported by granulocyte colony stimulating factors. Platelets greater than or equal to 100,000/mcl.\n      2. Renal function: Creatinine â‰¤1.5 x institutional upper limit normal (ULN).\n      3. Hepatic function: Bilirubin â‰¤ 1.5 x ULN. SGOT (AST) and SGPT (ALT) â‰¤ 3.0 x ULN and alkaline phosphatase â‰¤ 2.5 x ULN.\n      4. Neurologic function: Neuropathy (sensory and motor) less than or equal to Grade 1.\n     \n     \n 5.  Patients should be free of active infection requiring parenteral antibiotics or a serious uncontrolled medical illness or disorder within four weeks of study entry.\n 6.  Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to the first treatment. Continuation of hormone replacement therapy is permitted.\n 7.  Patients must have a performance status score of 0, 1 or 2 by Eastern Cooperative Group (ECOG) criteria.\n 8.  Patients of childbearing potential must have a negative serum pregnancy test within 14 days prior to initiation of protocol therapy and be practicing an effective form of contraception. If applicable, patients must discontinue breastfeeding prior to study entry.\n 9.  Patients must have satisfactory results for the baseline laboratory analyses and diagnostic procedures as specified in the protocol.\n 10. Patients must have signed an IRB-approved informed consent and authorization permitting release of personal health information.\n 11. Patients must be at least 18 years old.\n\n","\n\n 1.  Patients who have received prior treatment with GEN-1.\n 2.  History of allergic reactions attributed to compounds of similar chemical or biologic composition to GEN-1 or other agents used in this study.\n 3.  Patients who have received oral or parenteral corticosteroids within 2 weeks of study entry or who have a clinical requirement for ongoing systemic immunosuppressive therapy such as chronic steroid use not related to chemotherapy administration.\n 4.  Patients receiving treatment for active autoimmune disease. \"Active\" refers to any condition currently requiring therapy. Examples of autoimmune disease include systemic lupus erythematosus, multiple sclerosis, inflammatory bowel disease and rheumatoid arthritis.\n 5.  Patients with other invasive malignancies, with the exception of non-melanoma skin cancer and other specific malignancies as noted in the protocol are excluded if there is any evidence of other malignancy being present within the last three years. Patients are also excluded if their previous cancer treatment contraindicates this protocol therapy.\n 6.  Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded. Prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease.\n 7.  Patients who have received prior chemotherapy for any abdominal or pelvic tumor are excluded. Patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease.\n 8.  Patients with known active hepatitis.\n 9.  Patients with concurrent severe medical problems unrelated to the malignancy that would significantly limit full compliance with the study or expose the patient to extreme risk or decreased life expectancy.\n 10. Patients of childbearing potential, not practicing adequate contraception, patients who are pregnant, or patients who are breastfeeding are not eligible for this trial.\n 11. Patients with history or evidence upon physical examination of CNS disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date of treatment on this study.\n 12. Patients with any condition/anomaly that would interfere with the appropriate placement of the IP catheter for study drug administration including: abdominal surgery within 4 weeks of study entry (for reasons other than IP port placement), intestinal dysfunction, or suspected extensive adhesions from prior history or finding at laparoscopy.",{"$nulls":4},"Actual","2018-01-09","Actual","Anticipated","2023-10-31","Anticipated","2019-05-01","2018-01-03","2018-01-03","2019-05-30","Yes",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"Female",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":19},"PFS","The primary objective of the study is to evaluate safety and compare progression free survival between subjects receiving neoadjuvant chemotherapy (NACT) plus GEN-1 versus standard NACT.","The primary analysis for PFS will be conducted after at least 80 events have been observed or after all patients have been followed for at least 16 months, whichever is later.",{"$nulls":6},"Augusta, Georgia, United States, 30912 Northeast|Gainesville, Georgia, United States, 30501|Birmingham, Alabama, United States, 35233|La Jolla, California, United States, 92093-0698|Miramar, Florida, United States, 33027|Boston, Massachusetts, United States, 02114|Saint Louis, Missouri, United States, 63110|Billings, Montana, United States, 59101|Camden, New Jersey, United States, 08105|Lake Success, New York, United States, 11042|Winston-Salem, North Carolina, United States, 27101|Cleveland, Ohio, United States, 44195|Oklahoma City, Oklahoma, United States, 73104|Pittsburgh, Pennsylvania, United States, 15213 West Penn Hospital Of Allegheny Health NetworkPittsburgh, Pennsylvania, United States, 15224|Providence, Rhode Island, United States, 02905|Charleston, South Carolina, United States, 29425|Sioux Falls, South Dakota, United States, 57104|Chattanooga, Tennessee, United States, 37403|Milwaukee, Wisconsin, United States, 53226","Alabama|California|Florida|Massachusetts|Missouri|Montana|New Jersey|New York|North Carolina|Ohio|Oklahoma|Pennsylvania|Rhode Island|South Carolina|South Dakota|Tennessee|Wisconsin","Georgia|United States","Cancer Center At Augusta University|Medical Center|University Of Alabama Birmingham|University Of California - San Diego|The Center For Gynecologic Oncology|Massachusetts General Hospital|Washington University School Of Medicine In St. Louis|Billings Clinic|Cooper Health (Md Anderson)|Monter Cancer Center|Wake Forest School Of Medicine|Cleveland Clinic|Stephenson Cancer Center - Oklahoma University|University Of Pittsburgh Medical Center|Women & Infants Hopsital Of Rhode Island|Medical University Of South Carolina|Sanford Health|Chattanooga Women's Health|Medical College Of Wisconsin",{"$nulls":4},"2019-05-30","2020-05-25T16:35:51.982","2020-05-26T17:10:42.972","NCT03393884"]
["5ecbf3e811702c1b1b916a03","NCT03393884","2019-06-07","Celsion","CLSN","Recruiting","Study of GEN-1 With NACT for Treatment of Ovarian Cancer (OVATION 2) (OVATION 2)","Carboplatin|Paclitaxel","DNA Synthesis Inhibitor|Mitosis Inhibitor|Tubulin Inhibitor|Tubulin Inhibitor","Unknown",null,"Unknown",null,"Phase 1/Phase 2",2,130,"Anticipated","2018-09-05","2022-02-28","PFS","Progression Free Survival",{"$nulls":3},"This is a randomized, open label, multicenter trial to evaluate the safety, dosing, efficacy and biological activity of intraperitoneal GEN-1 plus NACT compared to NACT alone.",null,"A Phase I/II Study Evaluating the Dosing, Safety, Efficacy, and Biological Activity of Intraperitoneal GEN-1 (IL-12 Plasmid Formulated With PEG-PEI-Cholesterol Lipopolymer) Administered in Combination With Neoadjuvant Chemotherapy (NACT) in Patients Newly Diagnosed With Advanced Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer","201-17-201","Epithelial Ovarian Cancer\nFallopian Tube Cancer\nPrimary Peritoneal Cancer","Fallopian Tube Cancer|Ovarian Cancer","Oncology Solid Tumor","Oncology","Experimental|Active Comparator","NACT + GEN-1|NACT Alone","The NACT regimen will be paclitaxel 175 mg/m2 IV over 3 hours followed by carboplatin AUC 6 IV over 1 hour on Day 1. This will be repeated every 3 weeks for 6 cycles. GEN-1 100 mg/m2 IP will be administered on Days 8 and 15 of the first NACT cycle and then on Days 1, 8, and 15 of the subsequent 21 day NACT cycles for a total of 17 treatments.|The NACT regimen will be paclitaxel 175 mg/m2 IV over 3 hours followed by carboplatin AUC 6 IV over 1 hour on Day 1. This will be repeated every 3 weeks for 6 cycles.","Biological|Drug","GEN-1|Carboplatin|Paclitaxel","IL-12 Plasmid Formulated with PEG-PEI-Cholesterol Lipopolymer|AUC 6 IV over 1 hour on Day 1 of each cycle|175 mg/m2 IV over 3 hours on Day 1 of each cycle",null,"NACT + GEN-1|NACT Alone","\n\n 1.  Patients must have histologic diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal carcinoma per pre-treatment biopsies by laparoscopy, or interventional radiology or CT guided core biopsy. Histologic documentation of the original primary tumor is required via the pathology report.\n 2.  Patients must have an International Federation of Gynecology and Obstetrics (FIGO) of III or IV.\n 3.  Patients with the following histologic epithelial cell types are eligible: High grade serous adenocarcinoma, endometrioid adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, or adenocarcinoma not otherwise specified (N.O.S.).\n 4.  Patients must have adequate: 1. Bone marrow function: Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl. This ANC cannot have been induced or supported by granulocyte colony stimulating factors. Platelets greater than or equal to 100,000/mcl.\n      2. Renal function: Creatinine â‰¤1.5 x institutional upper limit normal (ULN).\n      3. Hepatic function: Bilirubin â‰¤ 1.5 x ULN. SGOT (AST) and SGPT (ALT) â‰¤ 3.0 x ULN and alkaline phosphatase â‰¤ 2.5 x ULN.\n      4. Neurologic function: Neuropathy (sensory and motor) less than or equal to Grade 1.\n     \n     \n 5.  Patients should be free of active infection requiring parenteral antibiotics or a serious uncontrolled medical illness or disorder within four weeks of study entry.\n 6.  Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to the first treatment. Continuation of hormone replacement therapy is permitted.\n 7.  Patients must have a performance status score of 0, 1 or 2 by Eastern Cooperative Group (ECOG) criteria.\n 8.  Patients of childbearing potential must have a negative serum pregnancy test within 14 days prior to initiation of protocol therapy and be practicing an effective form of contraception. If applicable, patients must discontinue breastfeeding prior to study entry.\n 9.  Patients must have satisfactory results for the baseline laboratory analyses and diagnostic procedures as specified in the protocol.\n 10. Patients must have signed an IRB-approved informed consent and authorization permitting release of personal health information.\n 11. Patients must be at least 18 years old.\n\n","\n\n 1.  Patients who have received prior treatment with GEN-1.\n 2.  History of allergic reactions attributed to compounds of similar chemical or biologic composition to GEN-1 or other agents used in this study.\n 3.  Patients who have received oral or parenteral corticosteroids within 2 weeks of study entry or who have a clinical requirement for ongoing systemic immunosuppressive therapy such as chronic steroid use not related to chemotherapy administration.\n 4.  Patients receiving treatment for active autoimmune disease. \"Active\" refers to any condition currently requiring therapy. Examples of autoimmune disease include systemic lupus erythematosus, multiple sclerosis, inflammatory bowel disease and rheumatoid arthritis.\n 5.  Patients with other invasive malignancies, with the exception of non-melanoma skin cancer and other specific malignancies as noted in the protocol are excluded if there is any evidence of other malignancy being present within the last three years. Patients are also excluded if their previous cancer treatment contraindicates this protocol therapy.\n 6.  Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded. Prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease.\n 7.  Patients who have received prior chemotherapy for any abdominal or pelvic tumor are excluded. Patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease.\n 8.  Patients with known active hepatitis.\n 9.  Patients with concurrent severe medical problems unrelated to the malignancy that would significantly limit full compliance with the study or expose the patient to extreme risk or decreased life expectancy.\n 10. Patients of childbearing potential, not practicing adequate contraception, patients who are pregnant, or patients who are breastfeeding are not eligible for this trial.\n 11. Patients with history or evidence upon physical examination of CNS disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date of treatment on this study.\n 12. Patients with any condition/anomaly that would interfere with the appropriate placement of the IP catheter for study drug administration including: abdominal surgery within 4 weeks of study entry (for reasons other than IP port placement), intestinal dysfunction, or suspected extensive adhesions from prior history or finding at laparoscopy.",{"$nulls":4},"Actual","2018-01-09","Actual","Anticipated","2023-10-31","Anticipated","2019-06-01","2018-01-03","2018-01-03","2019-06-06","Yes",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"Female",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":19},"PFS","The primary objective of the study is to evaluate safety and compare progression free survival between subjects receiving neoadjuvant chemotherapy (NACT) plus GEN-1 versus standard NACT.","The primary analysis for PFS will be conducted after at least 80 events have been observed or after all patients have been followed for at least 16 months, whichever is later.",{"$nulls":6},"Augusta, Georgia, United States, 30912 Northeast|Gainesville, Georgia, United States, 30501|Birmingham, Alabama, United States, 35233|La Jolla, California, United States, 92093-0698|Miramar, Florida, United States, 33027|Boston, Massachusetts, United States, 02114|Saint Louis, Missouri, United States, 63110|Billings, Montana, United States, 59101|Camden, New Jersey, United States, 08105|Lake Success, New York, United States, 11042|Winston-Salem, North Carolina, United States, 27101|Cleveland, Ohio, United States, 44195|Oklahoma City, Oklahoma, United States, 73104|Pittsburgh, Pennsylvania, United States, 15213 West Penn Hospital Of Allegheny Health NetworkPittsburgh, Pennsylvania, United States, 15224|Providence, Rhode Island, United States, 02905|Charleston, South Carolina, United States, 29425|Sioux Falls, South Dakota, United States, 57104|Chattanooga, Tennessee, United States, 37403|Milwaukee, Wisconsin, United States, 53226","Alabama|California|Florida|Massachusetts|Missouri|Montana|New Jersey|New York|North Carolina|Ohio|Oklahoma|Pennsylvania|Rhode Island|South Carolina|South Dakota|Tennessee|Wisconsin","Georgia|United States","Cancer Center At Augusta University|Medical Center|University Of Alabama Birmingham|University Of California - San Diego|The Center For Gynecologic Oncology|Massachusetts General Hospital|Washington University School Of Medicine In St. Louis|Billings Clinic|Cooper Health (Md Anderson)|Monter Cancer Center|Wake Forest School Of Medicine|Cleveland Clinic|Stephenson Cancer Center - Oklahoma University|University Of Pittsburgh Medical Center|Women & Infants Hopsital Of Rhode Island|Medical University Of South Carolina|Sanford Health|Chattanooga Women's Health|Medical College Of Wisconsin",{"$nulls":4},"2019-06-06","2020-05-25T16:35:52.002","2020-05-26T17:10:42.972","NCT03393884"]
["5ecbf3e7fe30261b1a0481f1","NCT03393884","2019-07-24","Celsion","CLSN","Recruiting","Study of GEN-1 With NACT for Treatment of Ovarian Cancer (OVATION 2) (OVATION 2)","Carboplatin|Paclitaxel","DNA Synthesis Inhibitor|Mitosis Inhibitor|Tubulin Inhibitor|Tubulin Inhibitor","Unknown",null,"Unknown",null,"Phase 1/Phase 2",2,130,"Anticipated","2018-09-05","2022-02-28","PFS","Progression Free Survival",{"$nulls":3},"This is a randomized, open label, multicenter trial to evaluate the safety, dosing, efficacy and biological activity of intraperitoneal GEN-1 plus NACT compared to NACT alone.",null,"A Phase I/II Study Evaluating the Dosing, Safety, Efficacy, and Biological Activity of Intraperitoneal GEN-1 (IL-12 Plasmid Formulated With PEG-PEI-Cholesterol Lipopolymer) Administered in Combination With Neoadjuvant Chemotherapy (NACT) in Patients Newly Diagnosed With Advanced Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer","201-17-201","Epithelial Ovarian Cancer\nFallopian Tube Cancer\nPrimary Peritoneal Cancer","Fallopian Tube Cancer|Ovarian Cancer","Oncology Solid Tumor","Oncology","Experimental|Active Comparator","NACT + GEN-1|NACT Alone","The NACT regimen will be paclitaxel 175 mg/m2 IV over 3 hours followed by carboplatin AUC 6 IV over 1 hour on Day 1. This will be repeated every 3 weeks for 6 cycles. GEN-1 100 mg/m2 IP will be administered on Days 8 and 15 of the first NACT cycle and then on Days 1, 8, and 15 of the subsequent 21 day NACT cycles for a total of 17 treatments.|The NACT regimen will be paclitaxel 175 mg/m2 IV over 3 hours followed by carboplatin AUC 6 IV over 1 hour on Day 1. This will be repeated every 3 weeks for 6 cycles.","Biological|Drug","GEN-1|Carboplatin|Paclitaxel","IL-12 Plasmid Formulated with PEG-PEI-Cholesterol Lipopolymer|AUC 6 IV over 1 hour on Day 1 of each cycle|175 mg/m2 IV over 3 hours on Day 1 of each cycle",null,"NACT + GEN-1|NACT Alone","\n\n 1.  Patients must have histologic diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal carcinoma per pre-treatment biopsies by laparoscopy, or interventional radiology or CT guided core biopsy. Histologic documentation of the original primary tumor is required via the pathology report.\n 2.  Patients must have an International Federation of Gynecology and Obstetrics (FIGO) of III or IV.\n 3.  Patients with the following histologic epithelial cell types are eligible: High grade serous adenocarcinoma, endometrioid adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, or adenocarcinoma not otherwise specified (N.O.S.).\n 4.  Patients must have adequate: 1. Bone marrow function: Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl. This ANC cannot have been induced or supported by granulocyte colony stimulating factors. Platelets greater than or equal to 100,000/mcl.\n      2. Renal function: Creatinine â‰¤1.5 x institutional upper limit normal (ULN).\n      3. Hepatic function: Bilirubin â‰¤ 1.5 x ULN. SGOT (AST) and SGPT (ALT) â‰¤ 3.0 x ULN and alkaline phosphatase â‰¤ 2.5 x ULN.\n      4. Neurologic function: Neuropathy (sensory and motor) less than or equal to Grade 1.\n     \n     \n 5.  Patients should be free of active infection requiring parenteral antibiotics or a serious uncontrolled medical illness or disorder within four weeks of study entry.\n 6.  Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to the first treatment. Continuation of hormone replacement therapy is permitted.\n 7.  Patients must have a performance status score of 0, 1 or 2 by Eastern Cooperative Group (ECOG) criteria.\n 8.  Patients of childbearing potential must have a negative serum pregnancy test within 14 days prior to initiation of protocol therapy and be practicing an effective form of contraception. If applicable, patients must discontinue breastfeeding prior to study entry.\n 9.  Patients must have satisfactory results for the baseline laboratory analyses and diagnostic procedures as specified in the protocol.\n 10. Patients must have signed an IRB-approved informed consent and authorization permitting release of personal health information.\n 11. Patients must be at least 18 years old.\n\n","\n\n 1.  Patients who have received prior treatment with GEN-1.\n 2.  History of allergic reactions attributed to compounds of similar chemical or biologic composition to GEN-1 or other agents used in this study.\n 3.  Patients who have received oral or parenteral corticosteroids within 2 weeks of study entry or who have a clinical requirement for ongoing systemic immunosuppressive therapy such as chronic steroid use not related to chemotherapy administration.\n 4.  Patients receiving treatment for active autoimmune disease. \"Active\" refers to any condition currently requiring therapy. Examples of autoimmune disease include systemic lupus erythematosus, multiple sclerosis, inflammatory bowel disease and rheumatoid arthritis.\n 5.  Patients with other invasive malignancies, with the exception of non-melanoma skin cancer and other specific malignancies as noted in the protocol are excluded if there is any evidence of other malignancy being present within the last three years. Patients are also excluded if their previous cancer treatment contraindicates this protocol therapy.\n 6.  Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded. Prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease.\n 7.  Patients who have received prior chemotherapy for any abdominal or pelvic tumor are excluded. Patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease.\n 8.  Patients with known active hepatitis.\n 9.  Patients with concurrent severe medical problems unrelated to the malignancy that would significantly limit full compliance with the study or expose the patient to extreme risk or decreased life expectancy.\n 10. Patients of childbearing potential, not practicing adequate contraception, patients who are pregnant, or patients who are breastfeeding are not eligible for this trial.\n 11. Patients with history or evidence upon physical examination of CNS disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date of treatment on this study.\n 12. Patients with any condition/anomaly that would interfere with the appropriate placement of the IP catheter for study drug administration including: abdominal surgery within 4 weeks of study entry (for reasons other than IP port placement), intestinal dysfunction, or suspected extensive adhesions from prior history or finding at laparoscopy.",{"$nulls":4},"Actual","2018-01-09","Actual","Anticipated","2023-10-31","Anticipated","2019-07-01","2018-01-03","2018-01-03","2019-07-23","Yes",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"Female",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":19},"PFS","The primary objective of the study is to evaluate safety and compare progression free survival between subjects receiving neoadjuvant chemotherapy (NACT) plus GEN-1 versus standard NACT.","The primary analysis for PFS will be conducted after at least 80 events have been observed or after all patients have been followed for at least 16 months, whichever is later.",{"$nulls":6},"Augusta, Georgia, United States, 30912 Northeast|Gainesville, Georgia, United States, 30501|Birmingham, Alabama, United States, 35233|La Jolla, California, United States, 92093-0698|Miramar, Florida, United States, 33027|Boston, Massachusetts, United States, 02114|Saint Louis, Missouri, United States, 63110|Billings, Montana, United States, 59101|Camden, New Jersey, United States, 08105|Lake Success, New York, United States, 11042|Winston-Salem, North Carolina, United States, 27101|Cleveland, Ohio, United States, 44195|Oklahoma City, Oklahoma, United States, 73104|Pittsburgh, Pennsylvania, United States, 15213 West Penn Hospital Of Allegheny Health NetworkPittsburgh, Pennsylvania, United States, 15224|Providence, Rhode Island, United States, 02905|Charleston, South Carolina, United States, 29425|Sioux Falls, South Dakota, United States, 57104|Chattanooga, Tennessee, United States, 37403|Milwaukee, Wisconsin, United States, 53226","Alabama|California|Florida|Massachusetts|Missouri|Montana|New Jersey|New York|North Carolina|Ohio|Oklahoma|Pennsylvania|Rhode Island|South Carolina|South Dakota|Tennessee|Wisconsin","Georgia|United States","Cancer Center At Augusta University|Medical Center|University Of Alabama Birmingham|University Of California - San Diego|The Center For Gynecologic Oncology|Massachusetts General Hospital|Washington University School Of Medicine In St. Louis|Billings Clinic|Cooper Health (Md Anderson)|Monter Cancer Center|Wake Forest School Of Medicine|Cleveland Clinic|Stephenson Cancer Center - Oklahoma University|University Of Pittsburgh Medical Center|Women & Infants Hopsital Of Rhode Island|Medical University Of South Carolina|Sanford Health|Chattanooga Women's Health|Medical College Of Wisconsin",{"$nulls":4},"2019-07-23","2020-05-25T16:35:51.755","2020-05-26T17:10:42.972","NCT03393884"]
["5ecbf3e811702c1b1b916a04","NCT03393884","2019-08-21","Celsion","CLSN","Recruiting","Study of GEN-1 With NACT for Treatment of Ovarian Cancer (OVATION 2) (OVATION 2)","Carboplatin|Paclitaxel","DNA Synthesis Inhibitor|Mitosis Inhibitor|Tubulin Inhibitor|Tubulin Inhibitor","Unknown",null,"Unknown",null,"Phase 1/Phase 2",2,130,"Anticipated","2018-09-05","2022-02-28","PFS","Progression Free Survival",{"$nulls":3},"This is a randomized, open label, multicenter trial to evaluate the safety, dosing, efficacy and biological activity of intraperitoneal GEN-1 plus NACT compared to NACT alone.",null,"A Phase I/II Study Evaluating the Dosing, Safety, Efficacy, and Biological Activity of Intraperitoneal GEN-1 (IL-12 Plasmid Formulated With PEG-PEI-Cholesterol Lipopolymer) Administered in Combination With Neoadjuvant Chemotherapy (NACT) in Patients Newly Diagnosed With Advanced Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer","201-17-201","Epithelial Ovarian Cancer\nFallopian Tube Cancer\nPrimary Peritoneal Cancer","Fallopian Tube Cancer|Ovarian Cancer","Oncology Solid Tumor","Oncology","Experimental|Active Comparator","NACT + GEN-1|NACT Alone","The NACT regimen will be paclitaxel 175 mg/m2 IV over 3 hours followed by carboplatin AUC 6 IV over 1 hour on Day 1. This will be repeated every 3 weeks for 6 cycles. GEN-1 100 mg/m2 IP will be administered on Days 8 and 15 of the first NACT cycle and then on Days 1, 8, and 15 of the subsequent 21 day NACT cycles for a total of 17 treatments.|The NACT regimen will be paclitaxel 175 mg/m2 IV over 3 hours followed by carboplatin AUC 6 IV over 1 hour on Day 1. This will be repeated every 3 weeks for 6 cycles.","Biological|Drug","GEN-1|Carboplatin|Paclitaxel","IL-12 Plasmid Formulated with PEG-PEI-Cholesterol Lipopolymer|AUC 6 IV over 1 hour on Day 1 of each cycle|175 mg/m2 IV over 3 hours on Day 1 of each cycle",null,"NACT + GEN-1|NACT Alone","\n\n 1.  Patients must have histologic diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal carcinoma per pre-treatment biopsies by laparoscopy, or interventional radiology or CT guided core biopsy. Histologic documentation of the original primary tumor is required via the pathology report.\n 2.  Patients must have an International Federation of Gynecology and Obstetrics (FIGO) of III or IV.\n 3.  Patients with the following histologic epithelial cell types are eligible: High grade serous adenocarcinoma, endometrioid adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, or adenocarcinoma not otherwise specified (N.O.S.).\n 4.  Patients must have adequate: 1. Bone marrow function: Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl. This ANC cannot have been induced or supported by granulocyte colony stimulating factors. Platelets greater than or equal to 100,000/mcl.\n      2. Renal function: Creatinine â‰¤1.5 x institutional upper limit normal (ULN).\n      3. Hepatic function: Bilirubin â‰¤ 1.5 x ULN. SGOT (AST) and SGPT (ALT) â‰¤ 3.0 x ULN and alkaline phosphatase â‰¤ 2.5 x ULN.\n      4. Neurologic function: Neuropathy (sensory and motor) less than or equal to Grade 1.\n     \n     \n 5.  Patients should be free of active infection requiring parenteral antibiotics or a serious uncontrolled medical illness or disorder within four weeks of study entry.\n 6.  Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to the first treatment. Continuation of hormone replacement therapy is permitted.\n 7.  Patients must have a performance status score of 0, 1 or 2 by Eastern Cooperative Group (ECOG) criteria.\n 8.  Patients of childbearing potential must have a negative serum pregnancy test within 14 days prior to initiation of protocol therapy and be practicing an effective form of contraception. If applicable, patients must discontinue breastfeeding prior to study entry.\n 9.  Patients must have satisfactory results for the baseline laboratory analyses and diagnostic procedures as specified in the protocol.\n 10. Patients must have signed an IRB-approved informed consent and authorization permitting release of personal health information.\n 11. Patients must be at least 18 years old.\n\n","\n\n 1.  Patients who have received prior treatment with GEN-1.\n 2.  History of allergic reactions attributed to compounds of similar chemical or biologic composition to GEN-1 or other agents used in this study.\n 3.  Patients who have received oral or parenteral corticosteroids within 2 weeks of study entry or who have a clinical requirement for ongoing systemic immunosuppressive therapy such as chronic steroid use not related to chemotherapy administration.\n 4.  Patients receiving treatment for active autoimmune disease. \"Active\" refers to any condition currently requiring therapy. Examples of autoimmune disease include systemic lupus erythematosus, multiple sclerosis, inflammatory bowel disease and rheumatoid arthritis.\n 5.  Patients with other invasive malignancies, with the exception of non-melanoma skin cancer and other specific malignancies as noted in the protocol are excluded if there is any evidence of other malignancy being present within the last three years. Patients are also excluded if their previous cancer treatment contraindicates this protocol therapy.\n 6.  Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded. Prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease.\n 7.  Patients who have received prior chemotherapy for any abdominal or pelvic tumor are excluded. Patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease.\n 8.  Patients with known active hepatitis.\n 9.  Patients with concurrent severe medical problems unrelated to the malignancy that would significantly limit full compliance with the study or expose the patient to extreme risk or decreased life expectancy.\n 10. Patients of childbearing potential, not practicing adequate contraception, patients who are pregnant, or patients who are breastfeeding are not eligible for this trial.\n 11. Patients with history or evidence upon physical examination of CNS disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date of treatment on this study.\n 12. Patients with any condition/anomaly that would interfere with the appropriate placement of the IP catheter for study drug administration including: abdominal surgery within 4 weeks of study entry (for reasons other than IP port placement), intestinal dysfunction, or suspected extensive adhesions from prior history or finding at laparoscopy.",{"$nulls":4},"Actual","2018-01-09","Actual","Anticipated","2023-10-31","Anticipated","2019-08-01","2018-01-03","2018-01-03","2019-08-20","Yes",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"Female",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":19},"PFS","The primary objective of the study is to evaluate safety and compare progression free survival between subjects receiving neoadjuvant chemotherapy (NACT) plus GEN-1 versus standard NACT.","The primary analysis for PFS will be conducted after at least 80 events have been observed or after all patients have been followed for at least 16 months, whichever is later.",{"$nulls":6},"Augusta, Georgia, United States, 30912 Northeast|Gainesville, Georgia, United States, 30501|Birmingham, Alabama, United States, 35233|La Jolla, California, United States, 92093-0698|Miramar, Florida, United States, 33027|Boston, Massachusetts, United States, 02114|Saint Louis, Missouri, United States, 63110|Billings, Montana, United States, 59101|Camden, New Jersey, United States, 08105|Lake Success, New York, United States, 11042|Winston-Salem, North Carolina, United States, 27101|Cleveland, Ohio, United States, 44195|Oklahoma City, Oklahoma, United States, 73104|Pittsburgh, Pennsylvania, United States, 15213 West Penn Hospital Of Allegheny Health NetworkPittsburgh, Pennsylvania, United States, 15224|Providence, Rhode Island, United States, 02905|Charleston, South Carolina, United States, 29425|Sioux Falls, South Dakota, United States, 57104|Chattanooga, Tennessee, United States, 37403|Milwaukee, Wisconsin, United States, 53226","Alabama|California|Florida|Massachusetts|Missouri|Montana|New Jersey|New York|North Carolina|Ohio|Oklahoma|Pennsylvania|Rhode Island|South Carolina|South Dakota|Tennessee|Wisconsin","Georgia|United States","Cancer Center At Augusta University|Medical Center|University Of Alabama Birmingham|University Of California - San Diego|The Center For Gynecologic Oncology|Massachusetts General Hospital|Washington University School Of Medicine In St. Louis|Billings Clinic|Cooper Health (Md Anderson)|Monter Cancer Center|Wake Forest School Of Medicine|Cleveland Clinic|Stephenson Cancer Center - Oklahoma University|University Of Pittsburgh Medical Center|Women & Infants Hopsital Of Rhode Island|Medical University Of South Carolina|Sanford Health|Chattanooga Women's Health|Medical College Of Wisconsin",{"$nulls":4},"2019-08-20","2020-05-25T16:35:52.282","2020-05-26T17:10:42.972","NCT03393884"]
["5ecbf3e7e2561b1b11905cec","NCT03393884","2019-10-14","Celsion","CLSN","Recruiting","Study of GEN-1 With NACT for Treatment of Ovarian Cancer (OVATION 2) (OVATION 2)","Carboplatin|Paclitaxel","DNA Synthesis Inhibitor|Mitosis Inhibitor|Tubulin Inhibitor|Tubulin Inhibitor","Unknown",null,"Unknown",null,"Phase 1/Phase 2",2,130,"Anticipated","2018-09-05","2022-02-28","PFS","Progression Free Survival",{"$nulls":3},"This is a randomized, open label, multicenter trial to evaluate the safety, dosing, efficacy and biological activity of intraperitoneal GEN-1 plus NACT compared to NACT alone.",null,"A Phase I/II Study Evaluating the Dosing, Safety, Efficacy, and Biological Activity of Intraperitoneal GEN-1 (IL-12 Plasmid Formulated With PEG-PEI-Cholesterol Lipopolymer) Administered in Combination With Neoadjuvant Chemotherapy (NACT) in Patients Newly Diagnosed With Advanced Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer","201-17-201","Epithelial Ovarian Cancer\nFallopian Tube Cancer\nPrimary Peritoneal Cancer","Fallopian Tube Cancer|Ovarian Cancer","Oncology Solid Tumor","Oncology","Experimental|Active Comparator","NACT + GEN-1|NACT Alone","The NACT regimen will be paclitaxel 175 mg/m2 IV over 3 hours followed by carboplatin AUC 6 IV over 1 hour on Day 1. This will be repeated every 3 weeks for 6 cycles. GEN-1 100 mg/m2 IP will be administered on Days 8 and 15 of the first NACT cycle and then on Days 1, 8, and 15 of the subsequent 21 day NACT cycles for a total of 17 treatments.|The NACT regimen will be paclitaxel 175 mg/m2 IV over 3 hours followed by carboplatin AUC 6 IV over 1 hour on Day 1. This will be repeated every 3 weeks for 6 cycles.","Biological|Drug","GEN-1|Carboplatin|Paclitaxel","IL-12 Plasmid Formulated with PEG-PEI-Cholesterol Lipopolymer|AUC 6 IV over 1 hour on Day 1 of each cycle|175 mg/m2 IV over 3 hours on Day 1 of each cycle",null,"NACT + GEN-1|NACT Alone","\n\n 1.  Patients must have histologic diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal carcinoma per pre-treatment biopsies by laparoscopy, or interventional radiology or CT guided core biopsy. Histologic documentation of the original primary tumor is required via the pathology report.\n 2.  Patients must have an International Federation of Gynecology and Obstetrics (FIGO) of III or IV.\n 3.  Patients with the following histologic epithelial cell types are eligible: High grade serous adenocarcinoma, endometrioid adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, or adenocarcinoma not otherwise specified (N.O.S.).\n 4.  Patients must have adequate: 1. Bone marrow function: Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl. This ANC cannot have been induced or supported by granulocyte colony stimulating factors. Platelets greater than or equal to 100,000/mcl.\n      2. Renal function: Creatinine â‰¤1.5 x institutional upper limit normal (ULN).\n      3. Hepatic function: Bilirubin â‰¤ 1.5 x ULN. SGOT (AST) and SGPT (ALT) â‰¤ 3.0 x ULN and alkaline phosphatase â‰¤ 2.5 x ULN.\n      4. Neurologic function: Neuropathy (sensory and motor) less than or equal to Grade 1.\n     \n     \n 5.  Patients should be free of active infection requiring parenteral antibiotics or a serious uncontrolled medical illness or disorder within four weeks of study entry.\n 6.  Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to the first treatment. Continuation of hormone replacement therapy is permitted.\n 7.  Patients must have a performance status score of 0, 1 or 2 by Eastern Cooperative Group (ECOG) criteria.\n 8.  Patients of childbearing potential must have a negative serum pregnancy test within 14 days prior to initiation of protocol therapy and be practicing an effective form of contraception. If applicable, patients must discontinue breastfeeding prior to study entry.\n 9.  Patients must have satisfactory results for the baseline laboratory analyses and diagnostic procedures as specified in the protocol.\n 10. Patients must have signed an IRB-approved informed consent and authorization permitting release of personal health information.\n 11. Patients must be at least 18 years old.\n\n","\n\n 1.  Patients who have received prior treatment with GEN-1.\n 2.  History of allergic reactions attributed to compounds of similar chemical or biologic composition to GEN-1 or other agents used in this study.\n 3.  Patients who have received oral or parenteral corticosteroids within 2 weeks of study entry or who have a clinical requirement for ongoing systemic immunosuppressive therapy such as chronic steroid use not related to chemotherapy administration.\n 4.  Patients receiving treatment for active autoimmune disease. \"Active\" refers to any condition currently requiring therapy. Examples of autoimmune disease include systemic lupus erythematosus, multiple sclerosis, inflammatory bowel disease and rheumatoid arthritis.\n 5.  Patients with other invasive malignancies, with the exception of non-melanoma skin cancer and other specific malignancies as noted in the protocol are excluded if there is any evidence of other malignancy being present within the last three years. Patients are also excluded if their previous cancer treatment contraindicates this protocol therapy.\n 6.  Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded. Prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease.\n 7.  Patients who have received prior chemotherapy for any abdominal or pelvic tumor are excluded. Patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease.\n 8.  Patients with known active hepatitis.\n 9.  Patients with concurrent severe medical problems unrelated to the malignancy that would significantly limit full compliance with the study or expose the patient to extreme risk or decreased life expectancy.\n 10. Patients of childbearing potential, not practicing adequate contraception, patients who are pregnant, or patients who are breastfeeding are not eligible for this trial.\n 11. Patients with history or evidence upon physical examination of CNS disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date of treatment on this study.\n 12. Patients with any condition/anomaly that would interfere with the appropriate placement of the IP catheter for study drug administration including: abdominal surgery within 4 weeks of study entry (for reasons other than IP port placement), intestinal dysfunction, or suspected extensive adhesions from prior history or finding at laparoscopy.",{"$nulls":4},"Actual","2018-01-09","Actual","Anticipated","2023-10-31","Anticipated","2019-10-01","2018-01-03","2018-01-03","2019-10-10","Yes",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"Female",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":19},"PFS","The primary objective of the study is to evaluate safety and compare progression free survival between subjects receiving neoadjuvant chemotherapy (NACT) plus GEN-1 versus standard NACT.","The primary analysis for PFS will be conducted after at least 80 events have been observed or after all patients have been followed for at least 16 months, whichever is later.",{"$nulls":6},"Augusta, Georgia, United States, 30912 Northeast|Gainesville, Georgia, United States, 30501|Birmingham, Alabama, United States, 35233|La Jolla, California, United States, 92093-0698|Miramar, Florida, United States, 33027|Boston, Massachusetts, United States, 02114|Saint Louis, Missouri, United States, 63110|Billings, Montana, United States, 59101|Camden, New Jersey, United States, 08105|Lake Success, New York, United States, 11042|Winston-Salem, North Carolina, United States, 27101|Cleveland, Ohio, United States, 44195 Ohio State UniversityColumbus, Ohio, United States, 45221|Oklahoma City, Oklahoma, United States, 73104|Pittsburgh, Pennsylvania, United States, 15213 West Penn Hospital Of Allegheny Health NetworkPittsburgh, Pennsylvania, United States, 15224|Providence, Rhode Island, United States, 02905|Charleston, South Carolina, United States, 29425|Sioux Falls, South Dakota, United States, 57104|Chattanooga, Tennessee, United States, 37403|Milwaukee, Wisconsin, United States, 53226","Alabama|California|Florida|Massachusetts|Missouri|Montana|New Jersey|New York|North Carolina|Ohio|Oklahoma|Pennsylvania|Rhode Island|South Carolina|South Dakota|Tennessee|Wisconsin","Georgia|United States","Cancer Center At Augusta University|Medical Center|University Of Alabama Birmingham|University Of California - San Diego|The Center For Gynecologic Oncology|Massachusetts General Hospital|Washington University School Of Medicine In St. Louis|Billings Clinic|Cooper Health (Md Anderson)|Monter Cancer Center|Wake Forest School Of Medicine|Cleveland Clinic|Stephenson Cancer Center - Oklahoma University|University Of Pittsburgh Medical Center|Women & Infants Hopsital Of Rhode Island|Medical University Of South Carolina|Sanford Health|Chattanooga Women's Health|Medical College Of Wisconsin",{"$nulls":4},"2019-10-10","2020-05-25T16:35:51.777","2020-05-26T17:10:42.972","NCT03393884"]
["5ecbf3e7307e3d1b1f8d9c82","NCT03393884","2019-11-05","Celsion","CLSN","Recruiting","Study of GEN-1 With NACT for Treatment of Ovarian Cancer (OVATION 2) (OVATION 2)","Carboplatin|Paclitaxel","DNA Synthesis Inhibitor|Mitosis Inhibitor|Tubulin Inhibitor|Tubulin Inhibitor","Unknown",null,"Unknown",null,"Phase 1/Phase 2",2,130,"Anticipated","2018-09-05","2022-02-28","PFS","Progression Free Survival",{"$nulls":3},"This is a randomized, open label, multicenter trial to evaluate the safety, dosing, efficacy and biological activity of intraperitoneal GEN-1 plus NACT compared to NACT alone.",null,"A Phase I/II Study Evaluating the Dosing, Safety, Efficacy, and Biological Activity of Intraperitoneal GEN-1 (IL-12 Plasmid Formulated With PEG-PEI-Cholesterol Lipopolymer) Administered in Combination With Neoadjuvant Chemotherapy (NACT) in Patients Newly Diagnosed With Advanced Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer","201-17-201","Epithelial Ovarian Cancer\nFallopian Tube Cancer\nPrimary Peritoneal Cancer","Fallopian Tube Cancer|Ovarian Cancer","Oncology Solid Tumor","Oncology","Experimental|Active Comparator","NACT + GEN-1|NACT Alone","The NACT regimen will be paclitaxel 175 mg/m2 IV over 3 hours followed by carboplatin AUC 6 IV over 1 hour on Day 1. This will be repeated every 3 weeks for 6 cycles. GEN-1 100 mg/m2 IP will be administered on Days 8 and 15 of the first NACT cycle and then on Days 1, 8, and 15 of the subsequent 21 day NACT cycles for a total of 17 treatments.|The NACT regimen will be paclitaxel 175 mg/m2 IV over 3 hours followed by carboplatin AUC 6 IV over 1 hour on Day 1. This will be repeated every 3 weeks for 6 cycles.","Biological|Drug","GEN-1|Carboplatin|Paclitaxel","IL-12 Plasmid Formulated with PEG-PEI-Cholesterol Lipopolymer|AUC 6 IV over 1 hour on Day 1 of each cycle|175 mg/m2 IV over 3 hours on Day 1 of each cycle",null,"NACT + GEN-1|NACT Alone","\n\n 1.  Patients must have histologic diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal carcinoma per pre-treatment biopsies by laparoscopy, or interventional radiology or CT guided core biopsy. Histologic documentation of the original primary tumor is required via the pathology report.\n 2.  Patients must have an International Federation of Gynecology and Obstetrics (FIGO) of III or IV.\n 3.  Patients with the following histologic epithelial cell types are eligible: High grade serous adenocarcinoma, endometrioid adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, or adenocarcinoma not otherwise specified (N.O.S.).\n 4.  Patients must have adequate: 1. Bone marrow function: Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl. This ANC cannot have been induced or supported by granulocyte colony stimulating factors. Platelets greater than or equal to 100,000/mcl.\n      2. Renal function: Creatinine â‰¤1.5 x institutional upper limit normal (ULN).\n      3. Hepatic function: Bilirubin â‰¤ 1.5 x ULN. SGOT (AST) and SGPT (ALT) â‰¤ 3.0 x ULN and alkaline phosphatase â‰¤ 2.5 x ULN.\n      4. Neurologic function: Neuropathy (sensory and motor) less than or equal to Grade 1.\n     \n     \n 5.  Patients should be free of active infection requiring parenteral antibiotics or a serious uncontrolled medical illness or disorder within four weeks of study entry.\n 6.  Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to the first treatment. Continuation of hormone replacement therapy is permitted.\n 7.  Patients must have a performance status score of 0, 1 or 2 by Eastern Cooperative Group (ECOG) criteria.\n 8.  Patients of childbearing potential must have a negative serum pregnancy test within 14 days prior to initiation of protocol therapy and be practicing an effective form of contraception. If applicable, patients must discontinue breastfeeding prior to study entry.\n 9.  Patients must have satisfactory results for the baseline laboratory analyses and diagnostic procedures as specified in the protocol.\n 10. Patients must have signed an IRB-approved informed consent and authorization permitting release of personal health information.\n 11. Patients must be at least 18 years old.\n\n","\n\n 1.  Patients who have received prior treatment with GEN-1.\n 2.  History of allergic reactions attributed to compounds of similar chemical or biologic composition to GEN-1 or other agents used in this study.\n 3.  Patients who have received oral or parenteral corticosteroids within 2 weeks of study entry or who have a clinical requirement for ongoing systemic immunosuppressive therapy such as chronic steroid use not related to chemotherapy administration.\n 4.  Patients receiving treatment for active autoimmune disease. \"Active\" refers to any condition currently requiring therapy. Examples of autoimmune disease include systemic lupus erythematosus, multiple sclerosis, inflammatory bowel disease and rheumatoid arthritis.\n 5.  Patients with other invasive malignancies, with the exception of non-melanoma skin cancer and other specific malignancies as noted in the protocol are excluded if there is any evidence of other malignancy being present within the last three years. Patients are also excluded if their previous cancer treatment contraindicates this protocol therapy.\n 6.  Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded. Prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease.\n 7.  Patients who have received prior chemotherapy for any abdominal or pelvic tumor are excluded. Patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease.\n 8.  Patients with known active hepatitis.\n 9.  Patients with concurrent severe medical problems unrelated to the malignancy that would significantly limit full compliance with the study or expose the patient to extreme risk or decreased life expectancy.\n 10. Patients of childbearing potential, not practicing adequate contraception, patients who are pregnant, or patients who are breastfeeding are not eligible for this trial.\n 11. Patients with history or evidence upon physical examination of CNS disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date of treatment on this study.\n 12. Patients with any condition/anomaly that would interfere with the appropriate placement of the IP catheter for study drug administration including: abdominal surgery within 4 weeks of study entry (for reasons other than IP port placement), intestinal dysfunction, or suspected extensive adhesions from prior history or finding at laparoscopy.",{"$nulls":4},"Actual","2018-01-09","Actual","Anticipated","2023-10-31","Anticipated","2019-11-01","2018-01-03","2018-01-03","2019-11-04","Yes",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"Female",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":19},"PFS","The primary objective of the study is to evaluate safety and compare progression free survival between subjects receiving neoadjuvant chemotherapy (NACT) plus GEN-1 versus standard NACT.","The primary analysis for PFS will be conducted after at least 80 events have been observed or after all patients have been followed for at least 16 months, whichever is later.",{"$nulls":6},"Augusta, Georgia, United States, 30912 Northeast|Gainesville, Georgia, United States, 30501|Birmingham, Alabama, United States, 35233|La Jolla, California, United States, 92093-0698|Miramar, Florida, United States, 33027|Boston, Massachusetts, United States, 02114|Saint Louis, Missouri, United States, 63110|Billings, Montana, United States, 59101|Camden, New Jersey, United States, 08105|Lake Success, New York, United States, 11042|Winston-Salem, North Carolina, United States, 27101|Cleveland, Ohio, United States, 44195 Ohio State UniversityColumbus, Ohio, United States, 45221|Oklahoma City, Oklahoma, United States, 73104|Pittsburgh, Pennsylvania, United States, 15213 West Penn Hospital Of Allegheny Health NetworkPittsburgh, Pennsylvania, United States, 15224|Providence, Rhode Island, United States, 02905|Charleston, South Carolina, United States, 29425|Sioux Falls, South Dakota, United States, 57104|Chattanooga, Tennessee, United States, 37403|Milwaukee, Wisconsin, United States, 53226","Alabama|California|Florida|Massachusetts|Missouri|Montana|New Jersey|New York|North Carolina|Ohio|Oklahoma|Pennsylvania|Rhode Island|South Carolina|South Dakota|Tennessee|Wisconsin","Georgia|United States","Cancer Center At Augusta University|Medical Center|University Of Alabama Birmingham|University Of California - San Diego|The Center For Gynecologic Oncology|Massachusetts General Hospital|Washington University School Of Medicine In St. Louis|Billings Clinic|Cooper Health (Md Anderson)|Monter Cancer Center|Wake Forest School Of Medicine|Cleveland Clinic|Stephenson Cancer Center - Oklahoma University|University Of Pittsburgh Medical Center|Women & Infants Hopsital Of Rhode Island|Medical University Of South Carolina|Sanford Health|Chattanooga Women's Health|Medical College Of Wisconsin",{"$nulls":4},"2019-11-04","2020-05-25T16:35:51.989","2020-05-26T17:10:42.972","NCT03393884"]
["5ecbf3e8e2561b1b11905ced","NCT03393884","2019-11-14","Celsion","CLSN","Recruiting","Study of GEN-1 With NACT for Treatment of Ovarian Cancer (OVATION 2) (OVATION 2)","Carboplatin|Paclitaxel","DNA Synthesis Inhibitor|Mitosis Inhibitor|Tubulin Inhibitor|Tubulin Inhibitor","Unknown",null,"Unknown",null,"Phase 1/Phase 2",2,130,"Anticipated","2018-09-05","2022-02-28","PFS","Progression Free Survival",{"$nulls":3},"This is a randomized, open label, multicenter trial to evaluate the safety, dosing, efficacy and biological activity of intraperitoneal GEN-1 plus NACT compared to NACT alone.",null,"A Phase I/II Study Evaluating the Dosing, Safety, Efficacy, and Biological Activity of Intraperitoneal GEN-1 (IL-12 Plasmid Formulated With PEG-PEI-Cholesterol Lipopolymer) Administered in Combination With Neoadjuvant Chemotherapy (NACT) in Patients Newly Diagnosed With Advanced Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer","201-17-201","Epithelial Ovarian Cancer\nFallopian Tube Cancer\nPrimary Peritoneal Cancer","Fallopian Tube Cancer|Ovarian Cancer","Oncology Solid Tumor","Oncology","Experimental|Active Comparator","NACT + GEN-1|NACT Alone","The NACT regimen will be paclitaxel 175 mg/m2 IV over 3 hours followed by carboplatin AUC 6 IV over 1 hour on Day 1. This will be repeated every 3 weeks for 6 cycles. GEN-1 100 mg/m2 IP will be administered on Days 8 and 15 of the first NACT cycle and then on Days 1, 8, and 15 of the subsequent 21 day NACT cycles for a total of 17 treatments.|The NACT regimen will be paclitaxel 175 mg/m2 IV over 3 hours followed by carboplatin AUC 6 IV over 1 hour on Day 1. This will be repeated every 3 weeks for 6 cycles.","Biological|Drug","GEN-1|Carboplatin|Paclitaxel","IL-12 Plasmid Formulated with PEG-PEI-Cholesterol Lipopolymer|AUC 6 IV over 1 hour on Day 1 of each cycle|175 mg/m2 IV over 3 hours on Day 1 of each cycle",null,"NACT + GEN-1|NACT Alone","\n\n 1.  Patients must have histologic diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal carcinoma per pre-treatment biopsies by laparoscopy, or interventional radiology or CT guided core biopsy. Histologic documentation of the original primary tumor is required via the pathology report.\n 2.  Patients must have an International Federation of Gynecology and Obstetrics (FIGO) of III or IV.\n 3.  Patients with the following histologic epithelial cell types are eligible: High grade serous adenocarcinoma, endometrioid adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, or adenocarcinoma not otherwise specified (N.O.S.).\n 4.  Patients must have adequate: 1. Bone marrow function: Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl. This ANC cannot have been induced or supported by granulocyte colony stimulating factors. Platelets greater than or equal to 100,000/mcl.\n      2. Renal function: Creatinine â‰¤1.5 x institutional upper limit normal (ULN).\n      3. Hepatic function: Bilirubin â‰¤ 1.5 x ULN. SGOT (AST) and SGPT (ALT) â‰¤ 3.0 x ULN and alkaline phosphatase â‰¤ 2.5 x ULN.\n      4. Neurologic function: Neuropathy (sensory and motor) less than or equal to Grade 1.\n     \n     \n 5.  Patients should be free of active infection requiring parenteral antibiotics or a serious uncontrolled medical illness or disorder within four weeks of study entry.\n 6.  Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to the first treatment. Continuation of hormone replacement therapy is permitted.\n 7.  Patients must have a performance status score of 0, 1 or 2 by Eastern Cooperative Group (ECOG) criteria.\n 8.  Patients of childbearing potential must have a negative serum pregnancy test within 14 days prior to initiation of protocol therapy and be practicing an effective form of contraception. If applicable, patients must discontinue breastfeeding prior to study entry.\n 9.  Patients must have satisfactory results for the baseline laboratory analyses and diagnostic procedures as specified in the protocol.\n 10. Patients must have signed an IRB-approved informed consent and authorization permitting release of personal health information.\n 11. Patients must be at least 18 years old.\n\n","\n\n 1.  Patients who have received prior treatment with GEN-1.\n 2.  History of allergic reactions attributed to compounds of similar chemical or biologic composition to GEN-1 or other agents used in this study.\n 3.  Patients who have received oral or parenteral corticosteroids within 2 weeks of study entry or who have a clinical requirement for ongoing systemic immunosuppressive therapy such as chronic steroid use not related to chemotherapy administration.\n 4.  Patients receiving treatment for active autoimmune disease. \"Active\" refers to any condition currently requiring therapy. Examples of autoimmune disease include systemic lupus erythematosus, multiple sclerosis, inflammatory bowel disease and rheumatoid arthritis.\n 5.  Patients with other invasive malignancies, with the exception of non-melanoma skin cancer and other specific malignancies as noted in the protocol are excluded if there is any evidence of other malignancy being present within the last three years. Patients are also excluded if their previous cancer treatment contraindicates this protocol therapy.\n 6.  Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded. Prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease.\n 7.  Patients who have received prior chemotherapy for any abdominal or pelvic tumor are excluded. Patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease.\n 8.  Patients with known active hepatitis.\n 9.  Patients with concurrent severe medical problems unrelated to the malignancy that would significantly limit full compliance with the study or expose the patient to extreme risk or decreased life expectancy.\n 10. Patients of childbearing potential, not practicing adequate contraception, patients who are pregnant, or patients who are breastfeeding are not eligible for this trial.\n 11. Patients with history or evidence upon physical examination of CNS disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date of treatment on this study.\n 12. Patients with any condition/anomaly that would interfere with the appropriate placement of the IP catheter for study drug administration including: abdominal surgery within 4 weeks of study entry (for reasons other than IP port placement), intestinal dysfunction, or suspected extensive adhesions from prior history or finding at laparoscopy.",{"$nulls":4},"Actual","2018-01-09","Actual","Anticipated","2023-10-31","Anticipated","2019-11-01","2018-01-03","2018-01-03","2019-11-12","Yes",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"Female",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":19},"PFS","The primary objective of the study is to evaluate safety and compare progression free survival between subjects receiving neoadjuvant chemotherapy (NACT) plus GEN-1 versus standard NACT.","The primary analysis for PFS will be conducted after at least 80 events have been observed or after all patients have been followed for at least 16 months, whichever is later.",{"$nulls":6},"Augusta, Georgia, United States, 30912 Northeast|Gainesville, Georgia, United States, 30501|Birmingham, Alabama, United States, 35233|La Jolla, California, United States, 92093-0698|Miramar, Florida, United States, 33027|Boston, Massachusetts, United States, 02114|Saint Louis, Missouri, United States, 63110|Billings, Montana, United States, 59101|Camden, New Jersey, United States, 08105|Lake Success, New York, United States, 11042|Winston-Salem, North Carolina, United States, 27101|Cleveland, Ohio, United States, 44195 Ohio State UniversityColumbus, Ohio, United States, 45221|Oklahoma City, Oklahoma, United States, 73104|Pittsburgh, Pennsylvania, United States, 15213 West Penn Hospital Of Allegheny Health NetworkPittsburgh, Pennsylvania, United States, 15224|Providence, Rhode Island, United States, 02905|Charleston, South Carolina, United States, 29425|Sioux Falls, South Dakota, United States, 57104|Chattanooga, Tennessee, United States, 37403|Milwaukee, Wisconsin, United States, 53226","Alabama|California|Florida|Massachusetts|Missouri|Montana|New Jersey|New York|North Carolina|Ohio|Oklahoma|Pennsylvania|Rhode Island|South Carolina|South Dakota|Tennessee|Wisconsin","Georgia|United States","Cancer Center At Augusta University|Medical Center|University Of Alabama Birmingham|University Of California - San Diego|The Center For Gynecologic Oncology|Massachusetts General Hospital|Washington University School Of Medicine In St. Louis|Billings Clinic|Cooper Health (Md Anderson)|Monter Cancer Center|Wake Forest School Of Medicine|Cleveland Clinic|Stephenson Cancer Center - Oklahoma University|University Of Pittsburgh Medical Center|Women & Infants Hopsital Of Rhode Island|Medical University Of South Carolina|Sanford Health|Chattanooga Women's Health|Medical College Of Wisconsin",{"$nulls":4},"2019-11-12","2020-05-25T16:35:52.168","2020-05-26T17:10:42.972","NCT03393884"]
["5ecbf3e8fe30261b1a0481f2","NCT03393884","2020-03-30","Celsion","CLSN","Active, not recruiting","Study of GEN-1 With NACT for Treatment of Ovarian Cancer (OVATION 2) (OVATION 2)","Carboplatin|Paclitaxel","DNA Synthesis Inhibitor|Mitosis Inhibitor|Tubulin Inhibitor|Tubulin Inhibitor","Unknown",null,"Unknown",null,"Phase 1/Phase 2",2,130,"Anticipated","2018-09-05","2022-02-28","PFS","Progression Free Survival",{"$nulls":3},"This is a randomized, open label, multicenter trial to evaluate the safety, dosing, efficacy and biological activity of intraperitoneal GEN-1 plus NACT compared to NACT alone.",null,"A Phase I/II Study Evaluating the Dosing, Safety, Efficacy, and Biological Activity of Intraperitoneal GEN-1 (IL-12 Plasmid Formulated With PEG-PEI-Cholesterol Lipopolymer) Administered in Combination With Neoadjuvant Chemotherapy (NACT) in Patients Newly Diagnosed With Advanced Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer","201-17-201","Epithelial Ovarian Cancer\nFallopian Tube Cancer\nPrimary Peritoneal Cancer","Fallopian Tube Cancer|Ovarian Cancer","Oncology Solid Tumor","Oncology","Experimental|Active Comparator","NACT + GEN-1|NACT Alone","The NACT regimen will be paclitaxel 175 mg/m2 IV over 3 hours followed by carboplatin AUC 6 IV over 1 hour on Day 1. This will be repeated every 3 weeks for 6 cycles. GEN-1 100 mg/m2 IP will be administered on Days 8 and 15 of the first NACT cycle and then on Days 1, 8, and 15 of the subsequent 21 day NACT cycles for a total of 17 treatments.|The NACT regimen will be paclitaxel 175 mg/m2 IV over 3 hours followed by carboplatin AUC 6 IV over 1 hour on Day 1. This will be repeated every 3 weeks for 6 cycles.","Biological|Drug","GEN-1|Carboplatin|Paclitaxel","IL-12 Plasmid Formulated with PEG-PEI-Cholesterol Lipopolymer|AUC 6 IV over 1 hour on Day 1 of each cycle|175 mg/m2 IV over 3 hours on Day 1 of each cycle",null,"NACT + GEN-1|NACT Alone","\n\n 1.  Patients must have histologic diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal carcinoma per pre-treatment biopsies by laparoscopy, or interventional radiology or CT guided core biopsy. Histologic documentation of the original primary tumor is required via the pathology report.\n 2.  Patients must have an International Federation of Gynecology and Obstetrics (FIGO) of III or IV.\n 3.  Patients with the following histologic epithelial cell types are eligible: High grade serous adenocarcinoma, endometrioid adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, or adenocarcinoma not otherwise specified (N.O.S.).\n 4.  Patients must have adequate: 1. Bone marrow function: Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl. This ANC cannot have been induced or supported by granulocyte colony stimulating factors. Platelets greater than or equal to 100,000/mcl.\n      2. Renal function: Creatinine â‰¤1.5 x institutional upper limit normal (ULN).\n      3. Hepatic function: Bilirubin â‰¤ 1.5 x ULN. SGOT (AST) and SGPT (ALT) â‰¤ 3.0 x ULN and alkaline phosphatase â‰¤ 2.5 x ULN.\n      4. Neurologic function: Neuropathy (sensory and motor) less than or equal to Grade 1.\n     \n     \n 5.  Patients should be free of active infection requiring parenteral antibiotics or a serious uncontrolled medical illness or disorder within four weeks of study entry.\n 6.  Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to the first treatment. Continuation of hormone replacement therapy is permitted.\n 7.  Patients must have a performance status score of 0, 1 or 2 by Eastern Cooperative Group (ECOG) criteria.\n 8.  Patients of childbearing potential must have a negative serum pregnancy test within 14 days prior to initiation of protocol therapy and be practicing an effective form of contraception. If applicable, patients must discontinue breastfeeding prior to study entry.\n 9.  Patients must have satisfactory results for the baseline laboratory analyses and diagnostic procedures as specified in the protocol.\n 10. Patients must have signed an IRB-approved informed consent and authorization permitting release of personal health information.\n 11. Patients must be at least 18 years old.\n\n","\n\n 1.  Patients who have received prior treatment with GEN-1.\n 2.  History of allergic reactions attributed to compounds of similar chemical or biologic composition to GEN-1 or other agents used in this study.\n 3.  Patients who have received oral or parenteral corticosteroids within 2 weeks of study entry or who have a clinical requirement for ongoing systemic immunosuppressive therapy such as chronic steroid use not related to chemotherapy administration.\n 4.  Patients receiving treatment for active autoimmune disease. \"Active\" refers to any condition currently requiring therapy. Examples of autoimmune disease include systemic lupus erythematosus, multiple sclerosis, inflammatory bowel disease and rheumatoid arthritis.\n 5.  Patients with other invasive malignancies, with the exception of non-melanoma skin cancer and other specific malignancies as noted in the protocol are excluded if there is any evidence of other malignancy being present within the last three years. Patients are also excluded if their previous cancer treatment contraindicates this protocol therapy.\n 6.  Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded. Prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease.\n 7.  Patients who have received prior chemotherapy for any abdominal or pelvic tumor are excluded. Patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease.\n 8.  Patients with known active hepatitis.\n 9.  Patients with concurrent severe medical problems unrelated to the malignancy that would significantly limit full compliance with the study or expose the patient to extreme risk or decreased life expectancy.\n 10. Patients of childbearing potential, not practicing adequate contraception, patients who are pregnant, or patients who are breastfeeding are not eligible for this trial.\n 11. Patients with history or evidence upon physical examination of CNS disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date of treatment on this study.\n 12. Patients with any condition/anomaly that would interfere with the appropriate placement of the IP catheter for study drug administration including: abdominal surgery within 4 weeks of study entry (for reasons other than IP port placement), intestinal dysfunction, or suspected extensive adhesions from prior history or finding at laparoscopy.",{"$nulls":4},"Actual","2018-01-09","Actual","Anticipated","2023-10-31","Anticipated","2020-03-01","2018-01-03","2018-01-03","2020-03-27","Yes",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"Female",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":19},"PFS","The primary objective of the study is to evaluate safety and compare progression free survival between subjects receiving neoadjuvant chemotherapy (NACT) plus GEN-1 versus standard NACT.","The primary analysis for PFS will be conducted after at least 80 events have been observed or after all patients have been followed for at least 16 months, whichever is later.",{"$nulls":6},"Birmingham, Alabama, United States, 35233 Mitchell Cancer Institute (University Of South Alabama)Mobile, Alabama, United States, 36604|La Jolla, California, United States, 92093-0698 Gynecologic Oncology Associates (Hoag Hospital)Newport Beach, California, United States, 92663 Innovative Clinical ResearchWhittier, California, United States, 90603|Miramar, Florida, United States, 33027 Advent HealthOrlando, Florida, United States, 32803 Women'S Care FloridaSaint Petersburg, Florida, United States, 33701 Sarasota Memorial HospitalSarasota, Florida, United States, 34239|Boston, Massachusetts, United States, 02114|Saint Louis, Missouri, United States, 63110|Billings, Montana, United States, 59101|Camden, New Jersey, United States, 08105 Hackensack University Medical CenterHackensack, New Jersey, United States, 07601|Lake Success, New York, United States, 11042 Nyu LangoneNew York, New York, United States, 10016|Oklahoma City, Oklahoma, United States, 73104|Pittsburgh, Pennsylvania, United States, 15224|Sioux Falls, South Dakota, United States, 57104|Chattanooga, Tennessee, United States, 37403 The West ClinicGermantown, Tennessee, United States, 38138|Milwaukee, Wisconsin, United States, 53226","Alabama|California|Florida|Massachusetts|Missouri|Montana|New Jersey|New York|Oklahoma|Pennsylvania|South Dakota|Tennessee|Wisconsin","United States","University Of Alabama Birmingham|University Of California - San Diego|The Center For Gynecologic Oncology|Massachusetts General Hospital|Washington University School Of Medicine In St. Louis|Billings Clinic|Cooper Health (Md Anderson)|Monter Cancer Center|Stephenson Cancer Center - Oklahoma University|West Penn Hospital Of Allegheny Health Network|Sanford Health|Chattanooga Women's Health|Medical College Of Wisconsin",{"$nulls":4},"2020-03-27","2020-05-25T16:35:52.194","2020-05-26T17:10:42.972","NCT03393884"]
["5ecbf3e8307e3d1b1f8d9c83","NCT03393884","2020-04-27","Celsion","CLSN","Active, not recruiting","Study of GEN-1 With NACT for Treatment of Ovarian Cancer (OVATION 2) (OVATION 2)","Carboplatin|Paclitaxel","DNA Synthesis Inhibitor|Mitosis Inhibitor|Tubulin Inhibitor|Tubulin Inhibitor","Unknown",null,"Unknown",null,"Phase 1/Phase 2",2,130,"Anticipated","2018-09-05","2022-02-28","PFS","Progression Free Survival",{"$nulls":3},"This is a randomized, open label, multicenter trial to evaluate the safety, dosing, efficacy and biological activity of intraperitoneal GEN-1 plus NACT compared to NACT alone.",null,"A Phase I/II Study Evaluating the Dosing, Safety, Efficacy, and Biological Activity of Intraperitoneal GEN-1 (IL-12 Plasmid Formulated With PEG-PEI-Cholesterol Lipopolymer) Administered in Combination With Neoadjuvant Chemotherapy (NACT) in Patients Newly Diagnosed With Advanced Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer","201-17-201","Epithelial Ovarian Cancer\nFallopian Tube Cancer\nPrimary Peritoneal Cancer","Fallopian Tube Cancer|Ovarian Cancer","Oncology Solid Tumor","Oncology","Experimental|Active Comparator","NACT + GEN-1|NACT Alone","The NACT regimen will be paclitaxel 175 mg/m2 IV over 3 hours followed by carboplatin AUC 6 IV over 1 hour on Day 1. This will be repeated every 3 weeks for 6 cycles. GEN-1 100 mg/m2 IP will be administered on Days 8 and 15 of the first NACT cycle and then on Days 1, 8, and 15 of the subsequent 21 day NACT cycles for a total of 17 treatments.|The NACT regimen will be paclitaxel 175 mg/m2 IV over 3 hours followed by carboplatin AUC 6 IV over 1 hour on Day 1. This will be repeated every 3 weeks for 6 cycles.","Biological|Drug","GEN-1|Carboplatin|Paclitaxel","IL-12 Plasmid Formulated with PEG-PEI-Cholesterol Lipopolymer|AUC 6 IV over 1 hour on Day 1 of each cycle|175 mg/m2 IV over 3 hours on Day 1 of each cycle",null,"NACT + GEN-1|NACT Alone","\n\n 1.  Patients must have histologic diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal carcinoma per pre-treatment biopsies by laparoscopy, or interventional radiology or CT guided core biopsy. Histologic documentation of the original primary tumor is required via the pathology report.\n 2.  Patients must have an International Federation of Gynecology and Obstetrics (FIGO) of III or IV.\n 3.  Patients with the following histologic epithelial cell types are eligible: High grade serous adenocarcinoma, endometrioid adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, or adenocarcinoma not otherwise specified (N.O.S.).\n 4.  Patients must have adequate: 1. Bone marrow function: Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl. This ANC cannot have been induced or supported by granulocyte colony stimulating factors. Platelets greater than or equal to 100,000/mcl.\n      2. Renal function: Creatinine â‰¤1.5 x institutional upper limit normal (ULN).\n      3. Hepatic function: Bilirubin â‰¤ 1.5 x ULN. SGOT (AST) and SGPT (ALT) â‰¤ 3.0 x ULN and alkaline phosphatase â‰¤ 2.5 x ULN.\n      4. Neurologic function: Neuropathy (sensory and motor) less than or equal to Grade 1.\n     \n     \n 5.  Patients should be free of active infection requiring parenteral antibiotics or a serious uncontrolled medical illness or disorder within four weeks of study entry.\n 6.  Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to the first treatment. Continuation of hormone replacement therapy is permitted.\n 7.  Patients must have a performance status score of 0, 1 or 2 by Eastern Cooperative Group (ECOG) criteria.\n 8.  Patients of childbearing potential must have a negative serum pregnancy test within 14 days prior to initiation of protocol therapy and be practicing an effective form of contraception. If applicable, patients must discontinue breastfeeding prior to study entry.\n 9.  Patients must have satisfactory results for the baseline laboratory analyses and diagnostic procedures as specified in the protocol.\n 10. Patients must have signed an IRB-approved informed consent and authorization permitting release of personal health information.\n 11. Patients must be at least 18 years old.\n\n","\n\n 1.  Patients who have received prior treatment with GEN-1.\n 2.  History of allergic reactions attributed to compounds of similar chemical or biologic composition to GEN-1 or other agents used in this study.\n 3.  Patients who have received oral or parenteral corticosteroids within 2 weeks of study entry or who have a clinical requirement for ongoing systemic immunosuppressive therapy such as chronic steroid use not related to chemotherapy administration.\n 4.  Patients receiving treatment for active autoimmune disease. \"Active\" refers to any condition currently requiring therapy. Examples of autoimmune disease include systemic lupus erythematosus, multiple sclerosis, inflammatory bowel disease and rheumatoid arthritis.\n 5.  Patients with other invasive malignancies, with the exception of non-melanoma skin cancer and other specific malignancies as noted in the protocol are excluded if there is any evidence of other malignancy being present within the last three years. Patients are also excluded if their previous cancer treatment contraindicates this protocol therapy.\n 6.  Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded. Prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease.\n 7.  Patients who have received prior chemotherapy for any abdominal or pelvic tumor are excluded. Patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease.\n 8.  Patients with known active hepatitis.\n 9.  Patients with concurrent severe medical problems unrelated to the malignancy that would significantly limit full compliance with the study or expose the patient to extreme risk or decreased life expectancy.\n 10. Patients of childbearing potential, not practicing adequate contraception, patients who are pregnant, or patients who are breastfeeding are not eligible for this trial.\n 11. Patients with history or evidence upon physical examination of CNS disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date of treatment on this study.\n 12. Patients with any condition/anomaly that would interfere with the appropriate placement of the IP catheter for study drug administration including: abdominal surgery within 4 weeks of study entry (for reasons other than IP port placement), intestinal dysfunction, or suspected extensive adhesions from prior history or finding at laparoscopy.",{"$nulls":4},"Actual","2018-01-09","Actual","Anticipated","2023-10-31","Anticipated","2020-04-01","2018-01-03","2018-01-03","2020-04-24","Yes",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"Female",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":19},"PFS","The primary objective of the study is to evaluate safety and compare progression free survival between subjects receiving neoadjuvant chemotherapy (NACT) plus GEN-1 versus standard NACT.","The primary analysis for PFS will be conducted after at least 80 events have been observed or after all patients have been followed for at least 16 months, whichever is later.",{"$nulls":6},"Birmingham, Alabama, United States, 35233 Mitchell Cancer Institute (University Of South Alabama)Mobile, Alabama, United States, 36604|La Jolla, California, United States, 92093-0698 Gynecologic Oncology Associates (Hoag Hospital)Newport Beach, California, United States, 92663 Innovative Clinical ResearchWhittier, California, United States, 90603|Miramar, Florida, United States, 33027 Advent HealthOrlando, Florida, United States, 32803 Women'S Care FloridaSaint Petersburg, Florida, United States, 33701 Sarasota Memorial HospitalSarasota, Florida, United States, 34239|Boston, Massachusetts, United States, 02114|Saint Louis, Missouri, United States, 63110|Billings, Montana, United States, 59101|Camden, New Jersey, United States, 08105 Hackensack University Medical CenterHackensack, New Jersey, United States, 07601|Lake Success, New York, United States, 11042 Nyu LangoneNew York, New York, United States, 10016|Oklahoma City, Oklahoma, United States, 73104|Pittsburgh, Pennsylvania, United States, 15224|Sioux Falls, South Dakota, United States, 57104|Chattanooga, Tennessee, United States, 37403 The West ClinicGermantown, Tennessee, United States, 38138|Milwaukee, Wisconsin, United States, 53226","Alabama|California|Florida|Massachusetts|Missouri|Montana|New Jersey|New York|Oklahoma|Pennsylvania|South Dakota|Tennessee|Wisconsin","United States","University Of Alabama Birmingham|University Of California - San Diego|The Center For Gynecologic Oncology|Massachusetts General Hospital|Washington University School Of Medicine In St. Louis|Billings Clinic|Cooper Health (Md Anderson)|Monter Cancer Center|Stephenson Cancer Center - Oklahoma University|West Penn Hospital Of Allegheny Health Network|Sanford Health|Chattanooga Women's Health|Medical College Of Wisconsin",{"$nulls":4},"2020-04-24","2020-05-25T16:35:52.497","2020-05-26T17:10:42.972","NCT03393884"]
["5ecbf3e911702c1b1b916a07","NCT03394144","2018-01-09","AstraZeneca","AZN","Not yet recruiting","Study of AZD9150 and MEDI4736 (Durvalumab) in Japanese Adult Patients With Advanced Solid Malignancies","Azd-9150|Durvalumab","STAT3 Inhibitor|PDL-1 Inhibitor","Yes","['Azd-9150']","No",null,"Phase 1",1,12,"Anticipated","2018-01-31","2018-11-19",{"$nulls":5},"This is a phase I, open-label study to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of AZD9150 monotherapy and AZD9150 in combination with durvalumab in Japanese patients with advanced solid malignancies.",null,"A Phase I, Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of AZD9150 Monotherapy and AZD9150 in Combination With Durvalumab in Japanese Patients With Advanced Solid Malignancies","D5660C00017","Advanced Solid Malignancies","Oncology Solid Tumor Unspecified|Oncology Unspecified|Other","Oncology Solid Tumor|Oncology Unspecified|Other","Oncology|Other","Experimental","C1:AZD9150, C2:AZD9150+Durvalumab","After confirmed safety with Cohort 1, Cohort 2 will open","Drug","AZD9150, Durvalumab","After confirmed safety with Cohort 1, Cohort 2 will open. Patients allocated in each cohort will be evaluated for DLT",null,"C1:AZD9150, C2:AZD9150+Durvalumab","\n\n * Male and female patients must be at least 20 years of age.\n * Has an Eastern Cooperative Oncology Group (ECOG) PS score of 0 or 1.\n * Has measurable disease, defined as at least 1 lesion that can be accurately measured in at least 1 dimension (longest diameter to be recorded) with a minimum size of 10 mm by computerised tomography (CT) scan, except lymph nodes which must have minimum short axis size of 15 mm (CT scan slice thickness no greater than 5 mm in both cases).\n * Adequate organ and marrow function\n * Female subjects of childbearing potential and male subjects with partners of childbearing potential should ensure use of a highly effective method of birth control as defined in study protocol\n\nKey ","\n\n * Spinal cord compression unless asymptomatic and not requiring steroids for at least 4 weeks before the start of study treatment.\n * Patients must have completed any previous cancer-related treatments before enrolment.\n * Has active or prior autoimmune disease within the past 2 years\n * Has active or prior inflammatory bowel disease or primary immunodeficiency\n * Undergone an organ transplant that requires use of immunosuppressive treatment\n * Abnormalities in rhythm, conduction or morphology of resting 12-lead ECG\n * Prior exposure to AZD9150 or any other anti PD (L)1 antibody.",{"$nulls":4},"Actual","2018-01-09","Actual","Anticipated","2018-11-19","Anticipated","2017-12-01","2017-11-10","2018-01-03","2018-01-03",null,null,"Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","20 Years","120 Years","All",null,"No",{"$nulls":4},"No","No",{"$nulls":19},"Safety and tolerability in terms of adverse events","Number of subjects with adverse events as a measure of safety and tolerability including changes in vital signs, electrocardiograms (ECGs), safety and laboratory parameters","From obtaining the first informed consent until 28 days after the last dose (AZD9150). In patients with Durvalumab until 90 days after the last dose (Durvalumab). Expected to be for up to 12 months.","Maximum plasma concentration (Cmax)|Overall response rate|Duration of Response|Area under the plasma concentration-time curve (AUC)","Pharmacokinetics (PK) parameters will be derived using standard non-compartmental methods.|Defined as the proportion of subjects who achieve a response.|Defined as the interval from the first documentation of response to the earlier of the first documentation of definitive disease progression or death from any cause.|PK parameters will be derived using standard non-compartmental methods.","From obtaining the first informed consent until 28 days after the last dose (AZD9150). In patients with Durvalumab for 90 days for the last dose (Durvalumab). Expected to be for up to 12 months.|Assessed at every even numbered cycle with RECIST until disease progression. Expected to be for up to 12 months.","information.center@astrazeneca.com","AstraZeneca Clinical Study Information Center","1-877-240-9479","Kashiwa, Japan, 277-8577 Research SiteMatsuyama-Shi, Japan, 791-0280",null,"Japan","Research Site",{"$nulls":4},"2018-01-03","2020-05-25T16:35:53.581","2020-05-26T17:10:42.972","NCT03394144"]
["5ecbf3e9307e3d1b1f8d9c86","NCT03394144","2018-02-13","AstraZeneca","AZN","Recruiting","Study of AZD9150 and MEDI4736 (Durvalumab) in Japanese Adult Patients With Advanced Solid Malignancies","Azd-9150|Durvalumab","STAT3 Inhibitor|PDL-1 Inhibitor","Yes","['Azd-9150']","No",null,"Phase 1",1,12,"Anticipated","2018-01-30","2018-12-11",{"$nulls":5},"This is a phase I, open-label study to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of AZD9150 monotherapy and AZD9150 in combination with durvalumab in Japanese patients with advanced solid malignancies.",null,"A Phase I, Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of AZD9150 Monotherapy and AZD9150 in Combination With Durvalumab in Japanese Patients With Advanced Solid Malignancies","D5660C00017","Advanced Solid Malignancies","Oncology Solid Tumor Unspecified|Oncology Unspecified|Other","Oncology Solid Tumor|Oncology Unspecified|Other","Oncology|Other","Experimental","C1:AZD9150, C2:AZD9150+Durvalumab","After confirmed safety with Cohort 1, Cohort 2 will open","Drug","AZD9150, Durvalumab","After confirmed safety with Cohort 1, Cohort 2 will open. Patients allocated in each cohort will be evaluated for DLT",null,"C1:AZD9150, C2:AZD9150+Durvalumab","\n\n * Male and female patients must be at least 20 years of age.\n * Has an Eastern Cooperative Oncology Group (ECOG) PS score of 0 or 1.\n * Has measurable disease, defined as at least 1 lesion that can be accurately measured in at least 1 dimension (longest diameter to be recorded) with a minimum size of 10 mm by computerised tomography (CT) scan, except lymph nodes which must have minimum short axis size of 15 mm (CT scan slice thickness no greater than 5 mm in both cases).\n * Adequate organ and marrow function\n * Female subjects of childbearing potential and male subjects with partners of childbearing potential should ensure use of a highly effective method of birth control as defined in study protocol\n\nKey ","\n\n * Spinal cord compression unless asymptomatic and not requiring steroids for at least 4 weeks before the start of study treatment.\n * Patients must have completed any previous cancer-related treatments before enrolment.\n * Has active or prior autoimmune disease within the past 2 years\n * Has active or prior inflammatory bowel disease or primary immunodeficiency\n * Undergone an organ transplant that requires use of immunosuppressive treatment\n * Abnormalities in rhythm, conduction or morphology of resting 12-lead ECG\n * Prior exposure to AZD9150 or any other anti PD (L)1 antibody.",{"$nulls":4},"Actual","2018-01-09","Actual","Anticipated","2018-12-11","Anticipated","2018-02-01","2017-11-10","2018-01-03","2018-02-12",null,null,"Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","20 Years","120 Years","All",null,"No",{"$nulls":4},"No","No",{"$nulls":19},"Safety and tolerability in terms of adverse events","Number of subjects with adverse events as a measure of safety and tolerability including changes in vital signs, electrocardiograms (ECGs), safety and laboratory parameters","From obtaining the first informed consent until 28 days after the last dose (AZD9150). In patients with Durvalumab until 90 days after the last dose (Durvalumab). Expected to be for up to 12 months.","Maximum plasma concentration (Cmax)|Overall response rate|Duration of Response|Area under the plasma concentration-time curve (AUC)","Pharmacokinetics (PK) parameters will be derived using standard non-compartmental methods.|Defined as the proportion of subjects who achieve a response.|Defined as the interval from the first documentation of response to the earlier of the first documentation of definitive disease progression or death from any cause.|PK parameters will be derived using standard non-compartmental methods.","From obtaining the first informed consent until 28 days after the last dose (AZD9150). In patients with Durvalumab for 90 days for the last dose (Durvalumab). Expected to be for up to 12 months.|Assessed at every even numbered cycle with RECIST until disease progression. Expected to be for up to 12 months.","information.center@astrazeneca.com","AstraZeneca Clinical Study Information Center","1-877-240-9479","Kashiwa, Japan, 277-8577 Research SiteMatsuyama-Shi, Japan, 791-0280",null,"Japan","Research Site",{"$nulls":4},"2018-02-12","2020-05-25T16:35:53.650","2020-05-26T17:10:42.972","NCT03394144"]
["5ecbf3e9feab101b15530825","NCT03394144","2018-03-27","AstraZeneca","AZN","Recruiting","Study of AZD9150 and MEDI4736 (Durvalumab) in Japanese Adult Patients With Advanced Solid Malignancies","Azd-9150|Durvalumab","STAT3 Inhibitor|PDL-1 Inhibitor","Yes","['Azd-9150']","No",null,"Phase 1",1,12,"Anticipated","2018-01-30","2018-12-11",{"$nulls":5},"This is a phase I, open-label study to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of AZD9150 monotherapy and AZD9150 in combination with durvalumab in Japanese patients with advanced solid malignancies.",null,"A Phase I, Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of AZD9150 Monotherapy and AZD9150 in Combination With Durvalumab in Japanese Patients With Advanced Solid Malignancies","D5660C00017","Advanced Solid Malignancies","Oncology Solid Tumor Unspecified|Oncology Unspecified|Other","Oncology Solid Tumor|Oncology Unspecified|Other","Oncology|Other","Experimental","C1:AZD9150, C2:AZD9150+Durvalumab","After confirmed safety with Cohort 1, Cohort 2 will open","Drug","AZD9150, Durvalumab","After confirmed safety with Cohort 1, Cohort 2 will open. Patients allocated in each cohort will be evaluated for DLT",null,"C1:AZD9150, C2:AZD9150+Durvalumab","\n\n * Male and female patients must be at least 20 years of age.\n * Has an Eastern Cooperative Oncology Group (ECOG) PS score of 0 or 1.\n * Has measurable disease, defined as at least 1 lesion that can be accurately measured in at least 1 dimension (longest diameter to be recorded) with a minimum size of 10 mm by computerised tomography (CT) scan, except lymph nodes which must have minimum short axis size of 15 mm (CT scan slice thickness no greater than 5 mm in both cases).\n * Adequate organ and marrow function\n * Female subjects of childbearing potential and male subjects with partners of childbearing potential should ensure use of a highly effective method of birth control as defined in study protocol\n\nKey ","\n\n * Spinal cord compression unless asymptomatic and not requiring steroids for at least 4 weeks before the start of study treatment.\n * Patients must have completed any previous cancer-related treatments before enrolment.\n * Has active or prior autoimmune disease within the past 2 years\n * Has active or prior inflammatory bowel disease or primary immunodeficiency\n * Undergone an organ transplant that requires use of immunosuppressive treatment\n * Abnormalities in rhythm, conduction or morphology of resting 12-lead ECG\n * Prior exposure to AZD9150 or any other anti PD (L)1 antibody.",{"$nulls":4},"Actual","2018-01-09","Actual","Anticipated","2018-12-11","Anticipated","2018-03-01","2017-11-10","2018-01-03","2018-03-26",null,null,"Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","20 Years","120 Years","All",null,"No",{"$nulls":4},"No","No",{"$nulls":19},"Safety and tolerability in terms of adverse events","Number of subjects with adverse events as a measure of safety and tolerability including changes in vital signs, electrocardiograms (ECGs), safety and laboratory parameters","From obtaining the first informed consent until 28 days after the last dose (AZD9150). In patients with Durvalumab until 90 days after the last dose (Durvalumab). Expected to be for up to 12 months.","Maximum plasma concentration (Cmax)|Overall response rate|Duration of Response|Area under the plasma concentration-time curve (AUC)","Pharmacokinetics (PK) parameters will be derived using standard non-compartmental methods.|Defined as the proportion of subjects who achieve a response.|Defined as the interval from the first documentation of response to the earlier of the first documentation of definitive disease progression or death from any cause.|PK parameters will be derived using standard non-compartmental methods.","From obtaining the first informed consent until 28 days after the last dose (AZD9150). In patients with Durvalumab for 90 days for the last dose (Durvalumab). Expected to be for up to 12 months.|Assessed at every even numbered cycle with RECIST until disease progression. Expected to be for up to 12 months.","information.center@astrazeneca.com","AstraZeneca Clinical Study Information Center","1-877-240-9479","Kashiwa, Japan, 277-8577 Research SiteMatsuyama-Shi, Japan, 791-0280",null,"Japan","Research Site",{"$nulls":4},"2018-03-26","2020-05-25T16:35:53.638","2020-05-26T17:10:42.972","NCT03394144"]
["5ecbf3ebe2561b1b11905cf3","NCT03394144","2018-05-11","AstraZeneca","AZN","Recruiting","Study of AZD9150 and MEDI4736 (Durvalumab) in Japanese Adult Patients With Advanced Solid Malignancies","Azd-9150|Durvalumab","STAT3 Inhibitor|PDL-1 Inhibitor","Yes","['Azd-9150']","No",null,"Phase 1",1,12,"Anticipated","2018-01-30","2018-12-11",{"$nulls":5},"This is a phase I, open-label study to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of AZD9150 monotherapy and AZD9150 in combination with durvalumab in Japanese patients with advanced solid malignancies.",null,"A Phase I, Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of AZD9150 Monotherapy and AZD9150 in Combination With Durvalumab in Japanese Patients With Advanced Solid Malignancies","D5660C00017","Advanced Solid Malignancies","Oncology Solid Tumor Unspecified|Oncology Unspecified|Other","Oncology Solid Tumor|Oncology Unspecified|Other","Oncology|Other","Experimental","C1:AZD9150, C2:AZD9150+Durvalumab","After confirmed safety with Cohort 1, Cohort 2 will open","Drug","AZD9150, Durvalumab","After confirmed safety with Cohort 1, Cohort 2 will open. Patients allocated in each cohort will be evaluated for DLT",null,"C1:AZD9150, C2:AZD9150+Durvalumab","\n\n * Male and female patients must be at least 20 years of age.\n * Has an Eastern Cooperative Oncology Group (ECOG) PS score of 0 or 1.\n * Has measurable disease, defined as at least 1 lesion that can be accurately measured in at least 1 dimension (longest diameter to be recorded) with a minimum size of 10 mm by computerised tomography (CT) scan, except lymph nodes which must have minimum short axis size of 15 mm (CT scan slice thickness no greater than 5 mm in both cases).\n * Adequate organ and marrow function\n * Female subjects of childbearing potential and male subjects with partners of childbearing potential should ensure use of a highly effective method of birth control as defined in study protocol\n\nKey ","\n\n * Spinal cord compression unless asymptomatic and not requiring steroids for at least 4 weeks before the start of study treatment.\n * Patients must have completed any previous cancer-related treatments before enrolment.\n * Has active or prior autoimmune disease within the past 2 years\n * Has active or prior inflammatory bowel disease or primary immunodeficiency\n * Undergone an organ transplant that requires use of immunosuppressive treatment\n * Abnormalities in rhythm, conduction or morphology of resting 12-lead ECG\n * Prior exposure to AZD9150 or any other anti PD (L)1 antibody.",{"$nulls":4},"Actual","2018-01-09","Actual","Anticipated","2018-12-11","Anticipated","2018-05-01","2017-11-10","2018-01-03","2018-05-10",null,null,"Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","20 Years","120 Years","All",null,"No",{"$nulls":4},"No","No",{"$nulls":19},"Safety and tolerability in terms of adverse events","Number of subjects with adverse events as a measure of safety and tolerability including changes in vital signs, electrocardiograms (ECGs), safety and laboratory parameters","From obtaining the first informed consent until 28 days after the last dose (AZD9150). In patients with Durvalumab until 90 days after the last dose (Durvalumab). Expected to be for up to 12 months.","Maximum plasma concentration (Cmax)|Overall response rate|Duration of Response|Area under the plasma concentration-time curve (AUC)","Pharmacokinetics (PK) parameters will be derived using standard non-compartmental methods.|Defined as the proportion of subjects who achieve a response.|Defined as the interval from the first documentation of response to the earlier of the first documentation of definitive disease progression or death from any cause.|PK parameters will be derived using standard non-compartmental methods.","From obtaining the first informed consent until 28 days after the last dose (AZD9150). In patients with Durvalumab for 90 days for the last dose (Durvalumab). Expected to be for up to 12 months.|Assessed at every even numbered cycle with RECIST until disease progression. Expected to be for up to 12 months.","information.center@astrazeneca.com","AstraZeneca Clinical Study Information Center","1-877-240-9479","Kashiwa, Japan, 277-8577 Research SiteMatsuyama-Shi, Japan, 791-0280",null,"Japan","Research Site",{"$nulls":4},"2018-05-10","2020-05-25T16:35:55.161","2020-05-26T17:10:42.972","NCT03394144"]
["5ecbf3e9e2561b1b11905cf1","NCT03394144","2018-06-11","AstraZeneca","AZN","Recruiting","Study of AZD9150 and MEDI4736 (Durvalumab) in Japanese Adult Patients With Advanced Solid Malignancies","Azd-9150|Durvalumab","STAT3 Inhibitor|PDL-1 Inhibitor","Yes","['Azd-9150']","No",null,"Phase 1",1,12,"Anticipated","2018-01-30","2018-12-11",{"$nulls":5},"This is a phase I, open-label study to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of AZD9150 monotherapy and AZD9150 in combination with durvalumab in Japanese patients with advanced solid malignancies.",null,"A Phase I, Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of AZD9150 Monotherapy and AZD9150 in Combination With Durvalumab in Japanese Patients With Advanced Solid Malignancies","D5660C00017","Advanced Solid Malignancies","Oncology Solid Tumor Unspecified|Oncology Unspecified|Other","Oncology Solid Tumor|Oncology Unspecified|Other","Oncology|Other","Experimental","C1:AZD9150, C2:AZD9150+Durvalumab","After confirmed safety with Cohort 1, Cohort 2 will open","Drug","AZD9150, Durvalumab","After confirmed safety with Cohort 1, Cohort 2 will open. Patients allocated in each cohort will be evaluated for DLT",null,"C1:AZD9150, C2:AZD9150+Durvalumab","\n\n * Male and female patients must be at least 20 years of age.\n * Has an Eastern Cooperative Oncology Group (ECOG) PS score of 0 or 1.\n * Has measurable disease, defined as at least 1 lesion that can be accurately measured in at least 1 dimension (longest diameter to be recorded) with a minimum size of 10 mm by computerised tomography (CT) scan, except lymph nodes which must have minimum short axis size of 15 mm (CT scan slice thickness no greater than 5 mm in both cases).\n * Adequate organ and marrow function\n * Female subjects of childbearing potential and male subjects with partners of childbearing potential should ensure use of a highly effective method of birth control as defined in study protocol\n\nKey ","\n\n * Spinal cord compression unless asymptomatic and not requiring steroids for at least 4 weeks before the start of study treatment.\n * Patients must have completed any previous cancer-related treatments before enrolment.\n * Has active or prior autoimmune disease within the past 2 years\n * Has active or prior inflammatory bowel disease or primary immunodeficiency\n * Undergone an organ transplant that requires use of immunosuppressive treatment\n * Abnormalities in rhythm, conduction or morphology of resting 12-lead ECG\n * Prior exposure to AZD9150 or any other anti PD (L)1 antibody.",{"$nulls":4},"Actual","2018-01-09","Actual","Anticipated","2018-12-11","Anticipated","2018-06-01","2017-11-10","2018-01-03","2018-06-08",null,null,"Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","20 Years","120 Years","All",null,"No",{"$nulls":4},"No","No",{"$nulls":19},"Safety and tolerability in terms of adverse events","Number of subjects with adverse events as a measure of safety and tolerability including changes in vital signs, electrocardiograms (ECGs), safety and laboratory parameters","From obtaining the first informed consent until 28 days after the last dose (AZD9150). In patients with Durvalumab until 90 days after the last dose (Durvalumab). Expected to be for up to 12 months.","Maximum plasma concentration (Cmax)|Overall response rate|Duration of Response|Area under the plasma concentration-time curve (AUC)","Pharmacokinetics (PK) parameters will be derived using standard non-compartmental methods.|Defined as the proportion of subjects who achieve a response.|Defined as the interval from the first documentation of response to the earlier of the first documentation of definitive disease progression or death from any cause.|PK parameters will be derived using standard non-compartmental methods.","From obtaining the first informed consent until 28 days after the last dose (AZD9150). In patients with Durvalumab for 90 days for the last dose (Durvalumab). Expected to be for up to 12 months.|Assessed at every even numbered cycle with RECIST until disease progression. Expected to be for up to 12 months.","information.center@astrazeneca.com","AstraZeneca Clinical Study Information Center","1-877-240-9479","Kashiwa, Japan, 277-8577 Research SiteMatsuyama-Shi, Japan, 791-0280",null,"Japan","Research Site",{"$nulls":4},"2018-06-08","2020-05-25T16:35:53.693","2020-05-26T17:10:42.972","NCT03394144"]
["5ecbf3e9feab101b15530826","NCT03394144","2018-07-12","AstraZeneca","AZN","Recruiting","Study of AZD9150 and MEDI4736 (Durvalumab) in Japanese Adult Patients With Advanced Solid Malignancies","Azd-9150|Durvalumab","STAT3 Inhibitor|PDL-1 Inhibitor","Yes","['Azd-9150']","No",null,"Phase 1",1,12,"Anticipated","2018-01-30","2019-03-01",{"$nulls":5},"This is a phase I, open-label study to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of AZD9150 monotherapy and AZD9150 in combination with durvalumab in Japanese patients with advanced solid malignancies.",null,"A Phase I, Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of AZD9150 Monotherapy and AZD9150 in Combination With Durvalumab in Japanese Patients With Advanced Solid Malignancies","D5660C00017","Advanced Solid Malignancies","Oncology Solid Tumor Unspecified|Oncology Unspecified|Other","Oncology Solid Tumor|Oncology Unspecified|Other","Oncology|Other","Experimental","C1:AZD9150, C2:AZD9150+Durvalumab","After confirmed safety with Cohort 1, Cohort 2 will open","Drug","AZD9150, Durvalumab","After confirmed safety with Cohort 1, Cohort 2 will open. Patients allocated in each cohort will be evaluated for DLT",null,"C1:AZD9150, C2:AZD9150+Durvalumab","\n\n * Male and female patients must be at least 20 years of age.\n * Has an Eastern Cooperative Oncology Group (ECOG) PS score of 0 or 1.\n * Has measurable disease, defined as at least 1 lesion that can be accurately measured in at least 1 dimension (longest diameter to be recorded) with a minimum size of 10 mm by computerised tomography (CT) scan, except lymph nodes which must have minimum short axis size of 15 mm (CT scan slice thickness no greater than 5 mm in both cases).\n * Adequate organ and marrow function\n * Female subjects of childbearing potential and male subjects with partners of childbearing potential should ensure use of a highly effective method of birth control as defined in study protocol\n\nKey ","\n\n * Spinal cord compression unless asymptomatic and not requiring steroids for at least 4 weeks before the start of study treatment.\n * Patients must have completed any previous cancer-related treatments before enrolment.\n * Has active or prior autoimmune disease within the past 2 years\n * Has active or prior inflammatory bowel disease or primary immunodeficiency\n * Undergone an organ transplant that requires use of immunosuppressive treatment\n * Abnormalities in rhythm, conduction or morphology of resting 12-lead ECG\n * Prior exposure to AZD9150 or any other anti PD (L)1 antibody.",{"$nulls":4},"Actual","2018-01-09","Actual","Anticipated","2019-03-01","Anticipated","2018-07-01","2017-11-10","2018-01-03","2018-07-11",null,null,"Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","20 Years","120 Years","All",null,"No",{"$nulls":4},"No","No",{"$nulls":19},"Safety and tolerability in terms of adverse events","Number of subjects with adverse events as a measure of safety and tolerability including changes in vital signs, electrocardiograms (ECGs), safety and laboratory parameters","From obtaining the first informed consent until 28 days after the last dose (AZD9150). In patients with Durvalumab until 90 days after the last dose (Durvalumab). Expected to be for up to 12 months.","Maximum plasma concentration (Cmax)|Overall response rate|Duration of Response|Area under the plasma concentration-time curve (AUC)","Pharmacokinetics (PK) parameters will be derived using standard non-compartmental methods.|Defined as the proportion of subjects who achieve a response.|Defined as the interval from the first documentation of response to the earlier of the first documentation of definitive disease progression or death from any cause.|PK parameters will be derived using standard non-compartmental methods.","From obtaining the first informed consent until 28 days after the last dose (AZD9150). In patients with Durvalumab for 90 days for the last dose (Durvalumab). Expected to be for up to 12 months.|Assessed at every even numbered cycle with RECIST until disease progression. Expected to be for up to 12 months.","information.center@astrazeneca.com","AstraZeneca Clinical Study Information Center","1-877-240-9479","Kashiwa, Japan, 277-8577 Research SiteMatsuyama-Shi, Japan, 791-0280",null,"Japan","Research Site",{"$nulls":4},"2018-07-11","2020-05-25T16:35:53.706","2020-05-26T17:10:42.972","NCT03394144"]
["5ecbf3e911702c1b1b916a08","NCT03394144","2018-08-10","AstraZeneca","AZN","Recruiting","Study of AZD9150 and MEDI4736 (Durvalumab) in Japanese Adult Patients With Advanced Solid Malignancies","Azd-9150|Durvalumab","STAT3 Inhibitor|PDL-1 Inhibitor","Yes","['Azd-9150']","No",null,"Phase 1",1,12,"Anticipated","2018-01-30","2019-03-01",{"$nulls":5},"This is a phase I, open-label study to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of AZD9150 monotherapy and AZD9150 in combination with durvalumab in Japanese patients with advanced solid malignancies.",null,"A Phase I, Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of AZD9150 Monotherapy and AZD9150 in Combination With Durvalumab in Japanese Patients With Advanced Solid Malignancies","D5660C00017","Advanced Solid Malignancies","Oncology Solid Tumor Unspecified|Oncology Unspecified|Other","Oncology Solid Tumor|Oncology Unspecified|Other","Oncology|Other","Experimental","C1:AZD9150, C2:AZD9150+Durvalumab","After confirmed safety with Cohort 1, Cohort 2 will open","Drug","AZD9150, Durvalumab","After confirmed safety with Cohort 1, Cohort 2 will open. Patients allocated in each cohort will be evaluated for DLT",null,"C1:AZD9150, C2:AZD9150+Durvalumab","\n\n * Male and female patients must be at least 20 years of age.\n * Has an Eastern Cooperative Oncology Group (ECOG) PS score of 0 or 1.\n * Has measurable disease, defined as at least 1 lesion that can be accurately measured in at least 1 dimension (longest diameter to be recorded) with a minimum size of 10 mm by computerised tomography (CT) scan, except lymph nodes which must have minimum short axis size of 15 mm (CT scan slice thickness no greater than 5 mm in both cases).\n * Adequate organ and marrow function\n * Female subjects of childbearing potential and male subjects with partners of childbearing potential should ensure use of a highly effective method of birth control as defined in study protocol\n\nKey ","\n\n * Spinal cord compression unless asymptomatic and not requiring steroids for at least 4 weeks before the start of study treatment.\n * Patients must have completed any previous cancer-related treatments before enrolment.\n * Has active or prior autoimmune disease within the past 2 years\n * Has active or prior inflammatory bowel disease or primary immunodeficiency\n * Undergone an organ transplant that requires use of immunosuppressive treatment\n * Abnormalities in rhythm, conduction or morphology of resting 12-lead ECG\n * Prior exposure to AZD9150 or any other anti PD (L)1 antibody.",{"$nulls":4},"Actual","2018-01-09","Actual","Anticipated","2019-03-01","Anticipated","2018-08-01","2017-11-10","2018-01-03","2018-08-09",null,null,"Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","20 Years","120 Years","All",null,"No",{"$nulls":4},"No","No",{"$nulls":19},"Safety and tolerability in terms of adverse events","Number of subjects with adverse events as a measure of safety and tolerability including changes in vital signs, electrocardiograms (ECGs), safety and laboratory parameters","From obtaining the first informed consent until 28 days after the last dose (AZD9150). In patients with Durvalumab until 90 days after the last dose (Durvalumab). Expected to be for up to 12 months.","Maximum plasma concentration (Cmax)|Overall response rate|Duration of Response|Area under the plasma concentration-time curve (AUC)","Pharmacokinetics (PK) parameters will be derived using standard non-compartmental methods.|Defined as the proportion of subjects who achieve a response.|Defined as the interval from the first documentation of response to the earlier of the first documentation of definitive disease progression or death from any cause.|PK parameters will be derived using standard non-compartmental methods.","From obtaining the first informed consent until 28 days after the last dose (AZD9150). In patients with Durvalumab for 90 days for the last dose (Durvalumab). Expected to be for up to 12 months.|Assessed at every even numbered cycle with RECIST until disease progression. Expected to be for up to 12 months.","information.center@astrazeneca.com","AstraZeneca Clinical Study Information Center","1-877-240-9479","Kashiwa, Japan, 277-8577 Research SiteMatsuyama-Shi, Japan, 791-0280",null,"Japan","Research Site",{"$nulls":4},"2018-08-09","2020-05-25T16:35:53.776","2020-05-26T17:10:42.972","NCT03394144"]
["5ecbf3e9fe30261b1a0481f6","NCT03394144","2018-10-18","AstraZeneca","AZN","Active, not recruiting","Study of AZD9150 and MEDI4736 (Durvalumab) in Japanese Adult Patients With Advanced Solid Malignancies","Azd-9150|Durvalumab","STAT3 Inhibitor|PDL-1 Inhibitor","Yes","['Azd-9150']","No",null,"Phase 1",1,11,"Actual","2018-01-30","2019-03-04",{"$nulls":5},"This is a phase I, open-label study to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of AZD9150 monotherapy and AZD9150 in combination with durvalumab in Japanese patients with advanced solid malignancies.",null,"A Phase I, Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of AZD9150 Monotherapy and AZD9150 in Combination With Durvalumab in Japanese Patients With Advanced Solid Malignancies","D5660C00017","Advanced Solid Malignancies","Oncology Solid Tumor Unspecified|Oncology Unspecified|Other","Oncology Solid Tumor|Oncology Unspecified|Other","Oncology|Other","Experimental","C1:AZD9150, C2:AZD9150+Durvalumab","After confirmed safety with Cohort 1, Cohort 2 will open","Drug","AZD9150, Durvalumab","After confirmed safety with Cohort 1, Cohort 2 will open. Patients allocated in each cohort will be evaluated for DLT",null,"C1:AZD9150, C2:AZD9150+Durvalumab","\n\n * Male and female patients must be at least 20 years of age.\n * Has an Eastern Cooperative Oncology Group (ECOG) PS score of 0 or 1.\n * Has measurable disease, defined as at least 1 lesion that can be accurately measured in at least 1 dimension (longest diameter to be recorded) with a minimum size of 10 mm by computerised tomography (CT) scan, except lymph nodes which must have minimum short axis size of 15 mm (CT scan slice thickness no greater than 5 mm in both cases).\n * Adequate organ and marrow function\n * Female subjects of childbearing potential and male subjects with partners of childbearing potential should ensure use of a highly effective method of birth control as defined in study protocol\n\nKey ","\n\n * Spinal cord compression unless asymptomatic and not requiring steroids for at least 4 weeks before the start of study treatment.\n * Patients must have completed any previous cancer-related treatments before enrolment.\n * Has active or prior autoimmune disease within the past 2 years\n * Has active or prior inflammatory bowel disease or primary immunodeficiency\n * Undergone an organ transplant that requires use of immunosuppressive treatment\n * Abnormalities in rhythm, conduction or morphology of resting 12-lead ECG\n * Prior exposure to AZD9150 or any other anti PD (L)1 antibody.",{"$nulls":4},"Actual","2018-01-09","Actual","Anticipated","2019-03-04","Anticipated","2018-10-01","2017-11-10","2018-01-03","2018-10-17",null,null,"Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","20 Years","120 Years","All",null,"No",{"$nulls":4},"No","No",{"$nulls":19},"Safety and tolerability in terms of adverse events","Number of subjects with adverse events as a measure of safety and tolerability including changes in vital signs, electrocardiograms (ECGs), safety and laboratory parameters","From obtaining the first informed consent until 28 days after the last dose (AZD9150). In patients with Durvalumab until 90 days after the last dose (Durvalumab). Expected to be for up to 12 months.","Maximum plasma concentration (Cmax)|Overall response rate|Duration of Response|Area under the plasma concentration-time curve (AUC)","Pharmacokinetics (PK) parameters will be derived using standard non-compartmental methods.|Defined as the proportion of subjects who achieve a response.|Defined as the interval from the first documentation of response to the earlier of the first documentation of definitive disease progression or death from any cause.|PK parameters will be derived using standard non-compartmental methods.","From obtaining the first informed consent until 28 days after the last dose (AZD9150). In patients with Durvalumab for 90 days for the last dose (Durvalumab). Expected to be for up to 12 months.|Assessed at every even numbered cycle with RECIST until disease progression. Expected to be for up to 12 months.",{"$nulls":3},"Kashiwa, Japan, 277-8577 Research SiteMatsuyama-Shi, Japan, 791-0280",null,"Japan","Research Site",{"$nulls":4},"2018-10-17","2020-05-25T16:35:53.767","2020-05-26T17:10:42.972","NCT03394144"]
["5ecbf3ea307e3d1b1f8d9c88","NCT03394144","2018-11-20","AstraZeneca","AZN","Active, not recruiting","Study of AZD9150 and MEDI4736 (Durvalumab) in Japanese Adult Patients With Advanced Solid Malignancies","Azd-9150|Durvalumab","STAT3 Inhibitor|PDL-1 Inhibitor","Yes","['Azd-9150']","No",null,"Phase 1",1,11,"Actual","2018-01-30","2019-03-04",{"$nulls":5},"This is a phase I, open-label study to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of AZD9150 monotherapy and AZD9150 in combination with durvalumab in Japanese patients with advanced solid malignancies.",null,"A Phase I, Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of AZD9150 Monotherapy and AZD9150 in Combination With Durvalumab in Japanese Patients With Advanced Solid Malignancies","D5660C00017","Advanced Solid Malignancies","Oncology Solid Tumor Unspecified|Oncology Unspecified|Other","Oncology Solid Tumor|Oncology Unspecified|Other","Oncology|Other","Experimental","C1:AZD9150, C2:AZD9150+Durvalumab","After confirmed safety with Cohort 1, Cohort 2 will open","Drug","AZD9150, Durvalumab","After confirmed safety with Cohort 1, Cohort 2 will open. Patients allocated in each cohort will be evaluated for DLT",null,"C1:AZD9150, C2:AZD9150+Durvalumab","\n\n * Male and female patients must be at least 20 years of age.\n * Has an Eastern Cooperative Oncology Group (ECOG) PS score of 0 or 1.\n * Has measurable disease, defined as at least 1 lesion that can be accurately measured in at least 1 dimension (longest diameter to be recorded) with a minimum size of 10 mm by computerised tomography (CT) scan, except lymph nodes which must have minimum short axis size of 15 mm (CT scan slice thickness no greater than 5 mm in both cases).\n * Adequate organ and marrow function\n * Female subjects of childbearing potential and male subjects with partners of childbearing potential should ensure use of a highly effective method of birth control as defined in study protocol\n\nKey ","\n\n * Spinal cord compression unless asymptomatic and not requiring steroids for at least 4 weeks before the start of study treatment.\n * Patients must have completed any previous cancer-related treatments before enrolment.\n * Has active or prior autoimmune disease within the past 2 years\n * Has active or prior inflammatory bowel disease or primary immunodeficiency\n * Undergone an organ transplant that requires use of immunosuppressive treatment\n * Abnormalities in rhythm, conduction or morphology of resting 12-lead ECG\n * Prior exposure to AZD9150 or any other anti PD (L)1 antibody.",{"$nulls":4},"Actual","2018-01-09","Actual","Anticipated","2019-03-04","Anticipated","2018-11-01","2017-11-10","2018-01-03","2018-11-19",null,null,"Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","20 Years","120 Years","All",null,"No",{"$nulls":4},"No","No",{"$nulls":19},"Safety and tolerability in terms of adverse events","Number of subjects with adverse events as a measure of safety and tolerability including changes in vital signs, electrocardiograms (ECGs), safety and laboratory parameters","From obtaining the first informed consent until 28 days after the last dose (AZD9150). In patients with Durvalumab until 90 days after the last dose (Durvalumab). Expected to be for up to 12 months.","Maximum plasma concentration (Cmax)|Overall response rate|Duration of Response|Area under the plasma concentration-time curve (AUC)","Pharmacokinetics (PK) parameters will be derived using standard non-compartmental methods.|Defined as the proportion of subjects who achieve a response.|Defined as the interval from the first documentation of response to the earlier of the first documentation of definitive disease progression or death from any cause.|PK parameters will be derived using standard non-compartmental methods.","From obtaining the first informed consent until 28 days after the last dose (AZD9150). In patients with Durvalumab for 90 days for the last dose (Durvalumab). Expected to be for up to 12 months.|Assessed at every even numbered cycle with RECIST until disease progression. Expected to be for up to 12 months.",{"$nulls":3},"Kashiwa, Japan, 277-8577 Research SiteMatsuyama-Shi, Japan, 791-0280",null,"Japan","Research Site",{"$nulls":4},"2018-11-19","2020-05-25T16:35:54.289","2020-05-26T17:10:42.972","NCT03394144"]
["5ecbf3eafe30261b1a0481f7","NCT03394144","2019-01-02","AstraZeneca","AZN","Active, not recruiting","Study of AZD9150 and MEDI4736 (Durvalumab) in Japanese Adult Patients With Advanced Solid Malignancies","Azd-9150|Durvalumab","STAT3 Inhibitor|PDL-1 Inhibitor","Yes","['Azd-9150']","No",null,"Phase 1",1,11,"Actual","2018-01-30","2019-03-04",{"$nulls":5},"This is a phase I, open-label study to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of AZD9150 monotherapy and AZD9150 in combination with durvalumab in Japanese patients with advanced solid malignancies.",null,"A Phase I, Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of AZD9150 Monotherapy and AZD9150 in Combination With Durvalumab in Japanese Patients With Advanced Solid Malignancies","D5660C00017","Advanced Solid Malignancies","Oncology Solid Tumor Unspecified|Oncology Unspecified|Other","Oncology Solid Tumor|Oncology Unspecified|Other","Oncology|Other","Experimental","C1:AZD9150, C2:AZD9150+Durvalumab","After confirmed safety with Cohort 1, Cohort 2 will open","Drug","AZD9150, Durvalumab","After confirmed safety with Cohort 1, Cohort 2 will open. Patients allocated in each cohort will be evaluated for DLT",null,"C1:AZD9150, C2:AZD9150+Durvalumab","\n\n * Male and female patients must be at least 20 years of age.\n * Has an Eastern Cooperative Oncology Group (ECOG) PS score of 0 or 1.\n * Has measurable disease, defined as at least 1 lesion that can be accurately measured in at least 1 dimension (longest diameter to be recorded) with a minimum size of 10 mm by computerised tomography (CT) scan, except lymph nodes which must have minimum short axis size of 15 mm (CT scan slice thickness no greater than 5 mm in both cases).\n * Adequate organ and marrow function\n * Female subjects of childbearing potential and male subjects with partners of childbearing potential should ensure use of a highly effective method of birth control as defined in study protocol\n\nKey ","\n\n * Spinal cord compression unless asymptomatic and not requiring steroids for at least 4 weeks before the start of study treatment.\n * Patients must have completed any previous cancer-related treatments before enrolment.\n * Has active or prior autoimmune disease within the past 2 years\n * Has active or prior inflammatory bowel disease or primary immunodeficiency\n * Undergone an organ transplant that requires use of immunosuppressive treatment\n * Abnormalities in rhythm, conduction or morphology of resting 12-lead ECG\n * Prior exposure to AZD9150 or any other anti PD (L)1 antibody.",{"$nulls":4},"Actual","2018-01-09","Actual","Anticipated","2019-03-04","Anticipated","2018-12-01","2017-11-10","2018-01-03","2018-12-31",null,null,"Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","20 Years","120 Years","All",null,"No",{"$nulls":4},"No","No",{"$nulls":19},"Safety and tolerability in terms of adverse events","Number of subjects with adverse events as a measure of safety and tolerability including changes in vital signs, electrocardiograms (ECGs), safety and laboratory parameters","From obtaining the first informed consent until 28 days after the last dose (AZD9150). In patients with Durvalumab until 90 days after the last dose (Durvalumab). Expected to be for up to 12 months.","Maximum plasma concentration (Cmax)|Overall response rate|Duration of Response|Area under the plasma concentration-time curve (AUC)","Pharmacokinetics (PK) parameters will be derived using standard non-compartmental methods.|Defined as the proportion of subjects who achieve a response.|Defined as the interval from the first documentation of response to the earlier of the first documentation of definitive disease progression or death from any cause.|PK parameters will be derived using standard non-compartmental methods.","From obtaining the first informed consent until 28 days after the last dose (AZD9150). In patients with Durvalumab for 90 days for the last dose (Durvalumab). Expected to be for up to 12 months.|Assessed at every even numbered cycle with RECIST until disease progression. Expected to be for up to 12 months.",{"$nulls":3},"Kashiwa, Japan, 277-8577 Research SiteMatsuyama-Shi, Japan, 791-0280",null,"Japan","Research Site",{"$nulls":4},"2018-12-31","2020-05-25T16:35:54.184","2020-05-26T17:10:42.972","NCT03394144"]
["5ecbf3eafeab101b15530827","NCT03394144","2019-01-30","AstraZeneca","AZN","Active, not recruiting","Study of AZD9150 and MEDI4736 (Durvalumab) in Japanese Adult Patients With Advanced Solid Malignancies","Azd-9150|Durvalumab","STAT3 Inhibitor|PDL-1 Inhibitor","Yes","['Azd-9150']","No",null,"Phase 1",1,11,"Actual","2018-01-30","2019-03-04",{"$nulls":5},"This is a phase I, open-label study to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of AZD9150 monotherapy and AZD9150 in combination with durvalumab in Japanese patients with advanced solid malignancies.",null,"A Phase I, Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of AZD9150 Monotherapy and AZD9150 in Combination With Durvalumab in Japanese Patients With Advanced Solid Malignancies","D5660C00017","Advanced Solid Malignancies","Oncology Solid Tumor Unspecified|Oncology Unspecified|Other","Oncology Solid Tumor|Oncology Unspecified|Other","Oncology|Other","Experimental","C1:AZD9150, C2:AZD9150+Durvalumab","After confirmed safety with Cohort 1, Cohort 2 will open","Drug","AZD9150, Durvalumab","After confirmed safety with Cohort 1, Cohort 2 will open. Patients allocated in each cohort will be evaluated for DLT",null,"C1:AZD9150, C2:AZD9150+Durvalumab","\n\n * Male and female patients must be at least 20 years of age.\n * Has an Eastern Cooperative Oncology Group (ECOG) PS score of 0 or 1.\n * Has measurable disease, defined as at least 1 lesion that can be accurately measured in at least 1 dimension (longest diameter to be recorded) with a minimum size of 10 mm by computerised tomography (CT) scan, except lymph nodes which must have minimum short axis size of 15 mm (CT scan slice thickness no greater than 5 mm in both cases).\n * Adequate organ and marrow function\n * Female subjects of childbearing potential and male subjects with partners of childbearing potential should ensure use of a highly effective method of birth control as defined in study protocol\n\nKey ","\n\n * Spinal cord compression unless asymptomatic and not requiring steroids for at least 4 weeks before the start of study treatment.\n * Patients must have completed any previous cancer-related treatments before enrolment.\n * Has active or prior autoimmune disease within the past 2 years\n * Has active or prior inflammatory bowel disease or primary immunodeficiency\n * Undergone an organ transplant that requires use of immunosuppressive treatment\n * Abnormalities in rhythm, conduction or morphology of resting 12-lead ECG\n * Prior exposure to AZD9150 or any other anti PD (L)1 antibody.",{"$nulls":4},"Actual","2018-01-09","Actual","Anticipated","2019-03-04","Anticipated","2019-01-01","2017-11-10","2018-01-03","2019-01-29",null,null,"Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","20 Years","120 Years","All",null,"No",{"$nulls":4},"No","No",{"$nulls":19},"Safety and tolerability in terms of adverse events","Number of subjects with adverse events as a measure of safety and tolerability including changes in vital signs, electrocardiograms (ECGs), safety and laboratory parameters","From obtaining the first informed consent until 28 days after the last dose (AZD9150). In patients with Durvalumab until 90 days after the last dose (Durvalumab). Expected to be for up to 12 months.","Maximum plasma concentration (Cmax)|Overall response rate|Duration of Response|Area under the plasma concentration-time curve (AUC)","Pharmacokinetics (PK) parameters will be derived using standard non-compartmental methods.|Defined as the proportion of subjects who achieve a response.|Defined as the interval from the first documentation of response to the earlier of the first documentation of definitive disease progression or death from any cause.|PK parameters will be derived using standard non-compartmental methods.","From obtaining the first informed consent until 28 days after the last dose (AZD9150). In patients with Durvalumab for 90 days for the last dose (Durvalumab). Expected to be for up to 12 months.|Assessed at every even numbered cycle with RECIST until disease progression. Expected to be for up to 12 months.",{"$nulls":3},"Kashiwa, Japan, 277-8577 Research SiteMatsuyama-Shi, Japan, 791-0280",null,"Japan","Research Site",{"$nulls":4},"2019-01-29","2020-05-25T16:35:54.459","2020-05-26T17:10:42.972","NCT03394144"]
["5ecbf3eae2561b1b11905cf2","NCT03394144","2019-06-24","AstraZeneca","AZN","Completed","Study of AZD9150 and MEDI4736 (Durvalumab) in Japanese Adult Patients With Advanced Solid Malignancies","Azd-9150|Durvalumab","STAT3 Inhibitor|PDL-1 Inhibitor","Yes","['Azd-9150']","No",null,"Phase 1",1,11,"Actual","2018-01-30","2019-04-12",{"$nulls":5},"This is a phase I, open-label study to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of AZD9150 monotherapy and AZD9150 in combination with durvalumab in Japanese patients with advanced solid malignancies.",null,"A Phase I, Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of AZD9150 Monotherapy and AZD9150 in Combination With Durvalumab in Japanese Patients With Advanced Solid Malignancies","D5660C00017","Advanced Solid Malignancies","Oncology Solid Tumor Unspecified|Oncology Unspecified|Other","Oncology Solid Tumor|Oncology Unspecified|Other","Oncology|Other","Experimental","C1:AZD9150, C2:AZD9150+Durvalumab","After confirmed safety with Cohort 1, Cohort 2 will open","Drug","AZD9150, Durvalumab","After confirmed safety with Cohort 1, Cohort 2 will open. Patients allocated in each cohort will be evaluated for DLT",null,"C1:AZD9150, C2:AZD9150+Durvalumab","\n\n * Male and female patients must be at least 20 years of age.\n * Has an Eastern Cooperative Oncology Group (ECOG) PS score of 0 or 1.\n * Has measurable disease, defined as at least 1 lesion that can be accurately measured in at least 1 dimension (longest diameter to be recorded) with a minimum size of 10 mm by computerised tomography (CT) scan, except lymph nodes which must have minimum short axis size of 15 mm (CT scan slice thickness no greater than 5 mm in both cases).\n * Adequate organ and marrow function\n * Female subjects of childbearing potential and male subjects with partners of childbearing potential should ensure use of a highly effective method of birth control as defined in study protocol\n\nKey ","\n\n * Spinal cord compression unless asymptomatic and not requiring steroids for at least 4 weeks before the start of study treatment.\n * Patients must have completed any previous cancer-related treatments before enrolment.\n * Has active or prior autoimmune disease within the past 2 years\n * Has active or prior inflammatory bowel disease or primary immunodeficiency\n * Undergone an organ transplant that requires use of immunosuppressive treatment\n * Abnormalities in rhythm, conduction or morphology of resting 12-lead ECG\n * Prior exposure to AZD9150 or any other anti PD (L)1 antibody.",{"$nulls":4},"Actual","2018-01-09","Actual","Actual","2019-04-12","Actual","2019-06-01","2017-11-10","2018-01-03","2019-06-21",null,null,"Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","20 Years","120 Years","All",null,"No",{"$nulls":4},"No","No",{"$nulls":19},"Safety and tolerability in terms of adverse events","Number of subjects with adverse events as a measure of safety and tolerability including changes in vital signs, electrocardiograms (ECGs), safety and laboratory parameters","From obtaining the first informed consent until 28 days after the last dose (AZD9150). In patients with Durvalumab until 90 days after the last dose (Durvalumab). Expected to be for up to 12 months.","Maximum plasma concentration (Cmax)|Overall response rate|Duration of Response|Area under the plasma concentration-time curve (AUC)","Pharmacokinetics (PK) parameters will be derived using standard non-compartmental methods.|Defined as the proportion of subjects who achieve a response.|Defined as the interval from the first documentation of response to the earlier of the first documentation of definitive disease progression or death from any cause.|PK parameters will be derived using standard non-compartmental methods.","From obtaining the first informed consent until 28 days after the last dose (AZD9150). In patients with Durvalumab for 90 days for the last dose (Durvalumab). Expected to be for up to 12 months.|Assessed at every even numbered cycle with RECIST until disease progression. Expected to be for up to 12 months.",{"$nulls":3},"Kashiwa, Japan, 277-8577 Research SiteMatsuyama-Shi, Japan, 791-0280",null,"Japan","Research Site",{"$nulls":4},"2019-06-21","2020-05-25T16:35:54.184","2020-05-26T17:10:42.972","NCT03394144"]
["5ecbf3eb307e3d1b1f8d9c89","NCT03394482","2018-01-09","Lundbeck","HLUYY","Recruiting","Bioequivalence Study of Lu AF35700","Af-35700",null,"Yes","['Af-35700']","Unknown",null,"Phase 1",6,90,"Anticipated","2018-01-03","2018-06-20","AUC","Area Under The Curve",{"$nulls":3},"The purpose of this study is to establish bioequivalence of Lu AF35700 between the clinical formulation and the commercial formulation for three tablet strengths; 5, 10 and 20 mg",null,"Interventional, Randomized, Open-label, Three-group, Two-sequence Crossover, Single-dose, Bioequivalence Study of Lu AF35700 in Healthy Subjects Comparing the 5, 10 and 20 mg Commercial Tablet (Test) to the 5, 10 and 20 mg Clinical Tablet (Reference)","17481A","Healthy","Healthy Volunteers","Healthy","Healthy","Experimental","Lu AF35700 5 mg clinical formulation|Lu AF35700 5 mg commercial formulation|Lu AF35700 10 mg clinical formulation|Lu AF35700 10 mg commercial formulation|Lu AF35700 20 mg clinical formulation|Lu AF35700 20 mg commercial formulation",null,"Drug","Lu AF35700 5 mg clinical formulation|Lu AF35700 5 mg commercial formulation|Lu AF35700 10 mg clinical formulation|Lu AF35700 10 mg commercial formulation|Lu AF35700 20 mg clinical formulation|Lu AF35700 20 mg commercial formulation","Lu AF35700 tablets 5 mg oral single dose|Lu AF35700 tablets 10 mg oral single dose|Lu AF35700 tablets 20 mg oral single dose",null,"Lu AF35700 5 mg clinical formulation|Lu AF35700 5 mg commercial formulation|Lu AF35700 10 mg clinical formulation|Lu AF35700 10 mg commercial formulation|Lu AF35700 20 mg clinical formulation|Lu AF35700 20 mg commercial formulation","\n\n * Healthy men and women aged â‰¥18 and â‰¤55 years\n * Body Mass Index (BMI) of â‰¥18.5 and â‰¤32 kg/m2\n * Subject must be in good general health as assessed using medical history, clinical laboratory tests, and physical examination\n\n","\n\n * The subject must not be of childbearing potential (if a woman) or should use contraception, be surgically sterilized or not be sexually active (both sexes). Women must not be pregnant or lactating\n * The subject must not be a CYP2D6 or a CYP2C19 poor metaboliser\n * The subject has previously been dosed with Lu AF35700\n\nOther protocol defined inclusion and exclusion criteria may apply",{"$nulls":4},"Actual","2018-01-09","Actual","Anticipated","2018-07-13","Anticipated","2018-01-01","2018-01-03","2018-01-08","2018-01-08","No",null,"Interventional","Treatment","Crossover Assignment","None (Open Label)","Randomized","18 Years","55 Years","All",null,"Yes",{"$nulls":4},"No","No",{"$nulls":17},"2017-001335-39","EudraCT Number","AUC0-72h of Lu AF35700|Cmax of Lu AF35700","Area under the Lu AF35700 plasma concentration-time curve from zero to 72 hours post-dose (AUC0-72h)|Maximum observed plasma concentration (Cmax) of Lu AF35700","zero to 72 hours","Tmax of Lu AF35700|AUC0-t of Lu AF35700","Time to occurance of Cmax of Lu AF35700|Area under the Lu AF35700 concentration-time curve from zero to time of the last quantifiable plasma concentration","zero to 72 hours|zero to time of the last quantifiable plasma concentration","LundbeckClinicalTrials@Lundbeck.com","Email contact via H.Lundbeck A/S",4536301311,"Leeds, United Kingdom",null,"United Kingdom","Covance",{"$nulls":3},"Email contact via H.Lundbeck A/S","2018-01-08","2020-05-25T16:35:55.456","2020-05-26T17:10:42.972","NCT03394482"]
["5ecbf3ebfeab101b15530828","NCT03394482","2018-08-24","Lundbeck","HLUYY","Recruiting","Bioequivalence Study of Lu AF35700","Af-35700",null,"Yes","['Af-35700']","Unknown",null,"Phase 1",6,90,"Anticipated","2018-01-03","2018-10-05","AUC","Area Under The Curve",{"$nulls":3},"The purpose of this study is to establish bioequivalence of Lu AF35700 between the clinical formulation and the commercial formulation for three tablet strengths; 5, 10 and 20 mg",null,"Interventional, Randomized, Open-label, Three-group, Two-sequence Crossover, Single-dose, Bioequivalence Study of Lu AF35700 in Healthy Subjects Comparing the 5, 10 and 20 mg Commercial Tablet (Test) to the 5, 10 and 20 mg Clinical Tablet (Reference)","17481A","Healthy","Healthy Volunteers","Healthy","Healthy","Experimental","Lu AF35700 5 mg clinical formulation|Lu AF35700 5 mg commercial formulation|Lu AF35700 10 mg clinical formulation|Lu AF35700 10 mg commercial formulation|Lu AF35700 20 mg clinical formulation|Lu AF35700 20 mg commercial formulation",null,"Drug","Lu AF35700 5 mg clinical formulation|Lu AF35700 5 mg commercial formulation|Lu AF35700 10 mg clinical formulation|Lu AF35700 10 mg commercial formulation|Lu AF35700 20 mg clinical formulation|Lu AF35700 20 mg commercial formulation","Lu AF35700 tablets 5 mg oral single dose|Lu AF35700 tablets 10 mg oral single dose|Lu AF35700 tablets 20 mg oral single dose",null,"Lu AF35700 5 mg clinical formulation|Lu AF35700 5 mg commercial formulation|Lu AF35700 10 mg clinical formulation|Lu AF35700 10 mg commercial formulation|Lu AF35700 20 mg clinical formulation|Lu AF35700 20 mg commercial formulation","\n\n * Healthy men and women aged â‰¥18 and â‰¤55 years\n * Body Mass Index (BMI) of â‰¥18.5 and â‰¤32 kg/m2\n * Subject must be in good general health as assessed using medical history, clinical laboratory tests, and physical examination\n\n","\n\n * The subject must not be of childbearing potential (if a woman) or should use contraception, be surgically sterilized or not be sexually active (both sexes). Women must not be pregnant or lactating\n * The subject must not be a CYP2D6 or a CYP2C19 poor metaboliser\n * The subject has previously been dosed with Lu AF35700\n\nOther protocol defined inclusion and exclusion criteria may apply",{"$nulls":4},"Actual","2018-01-09","Actual","Anticipated","2018-10-05","Anticipated","2018-08-01","2018-01-03","2018-01-08","2018-08-23","No",null,"Interventional","Treatment","Crossover Assignment","None (Open Label)","Randomized","18 Years","55 Years","All",null,"Yes",{"$nulls":4},"No","No",{"$nulls":17},"2017-001335-39","EudraCT Number","AUC0-72h of Lu AF35700|Cmax of Lu AF35700","Area under the Lu AF35700 plasma concentration-time curve from zero to 72 hours post-dose (AUC0-72h)|Maximum observed plasma concentration (Cmax) of Lu AF35700","zero to 72 hours","Tmax of Lu AF35700|AUC0-t of Lu AF35700","Time to occurance of Cmax of Lu AF35700|Area under the Lu AF35700 concentration-time curve from zero to time of the last quantifiable plasma concentration","zero to 72 hours|zero to time of the last quantifiable plasma concentration","LundbeckClinicalTrials@Lundbeck.com","Email contact via H.Lundbeck A/S",4536301311,"Leeds, United Kingdom",null,"United Kingdom","Covance",{"$nulls":3},"Email contact via H.Lundbeck A/S","2018-08-23","2020-05-25T16:35:55.325","2020-05-26T17:10:42.972","NCT03394482"]
["5ecbf3ebfe30261b1a0481f8","NCT03394482","2018-11-29","Lundbeck","HLUYY","Completed","Bioequivalence Study of Lu AF35700","Af-35700",null,"Yes","['Af-35700']","Unknown",null,"Phase 1",6,87,"Actual","2018-01-03","2018-10-05","AUC","Area Under The Curve",{"$nulls":3},"The purpose of this study is to establish bioequivalence of Lu AF35700 between the clinical formulation and the commercial formulation for three tablet strengths; 5, 10 and 20 mg",null,"Interventional, Randomized, Open-label, Three-group, Two-sequence Crossover, Single-dose, Bioequivalence Study of Lu AF35700 in Healthy Subjects Comparing the 5, 10 and 20 mg Commercial Tablet (Test) to the 5, 10 and 20 mg Clinical Tablet (Reference)","17481A","Healthy","Healthy Volunteers","Healthy","Healthy","Experimental","Lu AF35700 5 mg clinical formulation|Lu AF35700 5 mg commercial formulation|Lu AF35700 10 mg clinical formulation|Lu AF35700 10 mg commercial formulation|Lu AF35700 20 mg clinical formulation|Lu AF35700 20 mg commercial formulation",null,"Drug","Lu AF35700 5 mg clinical formulation|Lu AF35700 5 mg commercial formulation|Lu AF35700 10 mg clinical formulation|Lu AF35700 10 mg commercial formulation|Lu AF35700 20 mg clinical formulation|Lu AF35700 20 mg commercial formulation","Lu AF35700 tablets 5 mg oral single dose|Lu AF35700 tablets 10 mg oral single dose|Lu AF35700 tablets 20 mg oral single dose",null,"Lu AF35700 5 mg clinical formulation|Lu AF35700 5 mg commercial formulation|Lu AF35700 10 mg clinical formulation|Lu AF35700 10 mg commercial formulation|Lu AF35700 20 mg clinical formulation|Lu AF35700 20 mg commercial formulation","\n\n * Healthy men and women aged â‰¥18 and â‰¤55 years\n * Body Mass Index (BMI) of â‰¥18.5 and â‰¤32 kg/m2\n * Subject must be in good general health as assessed using medical history, clinical laboratory tests, and physical examination\n\n","\n\n * The subject must not be of childbearing potential (if a woman) or should use contraception, be surgically sterilized or not be sexually active (both sexes). Women must not be pregnant or lactating\n * The subject must not be a CYP2D6 or a CYP2C19 poor metaboliser\n * The subject has previously been dosed with Lu AF35700\n\nOther protocol defined inclusion and exclusion criteria may apply",{"$nulls":4},"Actual","2018-01-09","Actual","Actual","2018-10-05","Actual","2018-11-01","2018-01-03","2018-01-08","2018-11-28","No",null,"Interventional","Treatment","Crossover Assignment","None (Open Label)","Randomized","18 Years","55 Years","All",null,"Yes",{"$nulls":4},"No","No",{"$nulls":17},"2017-001335-39","EudraCT Number","AUC0-72h of Lu AF35700|Cmax of Lu AF35700","Area under the Lu AF35700 plasma concentration-time curve from zero to 72 hours post-dose (AUC0-72h)|Maximum observed plasma concentration (Cmax) of Lu AF35700","zero to 72 hours","Tmax of Lu AF35700|AUC0-t of Lu AF35700","Time to occurance of Cmax of Lu AF35700|Area under the Lu AF35700 concentration-time curve from zero to time of the last quantifiable plasma concentration","zero to 72 hours|zero to time of the last quantifiable plasma concentration",{"$nulls":3},"Leeds, United Kingdom",null,"United Kingdom","Covance",{"$nulls":3},"Email contact via H.Lundbeck A/S","2018-11-28","2020-05-25T16:35:55.292","2020-05-26T17:10:42.972","NCT03394482"]
["5ecbf3ee307e3d1b1f8d9c8f","NCT03394781","2018-01-09","Durect","DRRX","Recruiting","A Research Study to Evaluate Safety and Efficacy of DUR-928 in Subjects With Primary Sclerosing Cholangitis (PSC)","Dur-928",null,"Yes","['Dur-928']","Unknown",null,"Phase 2",2,40,"Anticipated","2018-01-01","2019-01-01",{"$nulls":5},"This is a research trial testing DUR-928 (an experimental medication). The purpose of the trial is to assess whether treatment with DUR-928 has any effect on the treatment of Primary Sclerosing Cholangitis (PSC). This trial will also assess safety (side effects).",null,"A Randomized, Open-label, Phase 2 Study to Evaluate Safety and Efficacy of DUR-928 in Subjects With Primary Sclerosing Cholangitis (PSC)","C928-008","Primary Sclerosing Cholangitis","Cholangitis|Cholangitis, Sclerosing","Biliary Tract Diseases","Gastrointestinal","Experimental","DUR-928 10 mg|DUR-928 50 mg","10 mg oral suspension|50 mg oral suspension","Drug","DUR-928","oral suspension daily for 28 days",null,"DUR-928 10 mg|DUR-928 50 mg","\n\n * Verified diagnosis of PSC for at least 12 months, with or without IBD.\n * Serum (ALP) â‰¥ 1.5 times ULN and with no >15% fluctuation in the past 3 months.\n * In subjects receiving treatment with ursodeoxycholic acid (UDCA), therapy must be stable for at least 3 months and at a dose not greater than 20 mg/kg/day.\n * Subjects of childbearing potential must agree to use a medically acceptable method of contraceptive to prevent pregnancy in the subject and/or the partner for the duration of their participation in the trial up to 2 months after the last study drug dosing.\n\n","\n\n 1.  Presence of documented secondary sclerosing cholangitis.\n 2.  Small duct PSC\n 3.  Bacterial cholangitis within 30 days prior to Screening\n 4.  Presence of percutaneous drain or endoscopic bile duct stent\n 5.  History of, or suspicion of cholangiocarcinoma.\n 6.  Prior liver transplantation, or currently listed for liver transplantation\n 7.  Presence of other concomitant liver diseases\n 8.  Cirrhosis and/or hepatic impairment\n 9.  Moderate to Severe active IBD or flare in colitis activity within the last 3 months\n 10. Active Crohn's disease\n 11. Use of oral prednisolone > 10 mg/day, biologics and/or hospitalization for colitis within 90 days\n 12. AST, ALT, and total bilirubin above the allowed cut-offs\n 13. International normalized ratio (INR) â‰¥ 1.2\n 14. Subjects on anticoagulant therapy\n 15. Platelet count < 150,000/mm3\n 16. Immunoglobulin G4 (IgG4) > 130 mg/dL or 4 x ULN or evidence of IgG4-related sclerosing cholangitis\n 17. Any severe and/or untreated concomitant cardiovascular, renal, endocrine or psychiatric disorder\n 18. Average weekly alcohol ingestion of â‰¥ 30g/day for men and â‰¥ 20 g/day for females\n 19. Any active malignant disease (within 3 years), other than non-melanomatous skin cancer\n 20. Human immunodeficiency virus (HIV) infection\n 21. Existing or intended pregnancy, or breast feeding\n 22. Has received medication from another clinical trial within the past 30 days\n 23. In the opinion of the investigator, would make the subject unsuitable for the study or unable to comply with the dosing and protocol requirements",{"$nulls":4},"Actual","2018-01-09","Actual","Anticipated","2019-01-01","Anticipated","2018-01-01","2018-01-03","2018-01-08","2018-01-08","No",null,"Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years","80 Years","All",null,"No","Undecided",{"$nulls":3},"Yes","No",{"$nulls":19},"Number of participants with treatment-related adverse events as assessed by CTCAE v4.0|Percent change of ALP from baseline","through 4 weeks of dosing until 56 days post-dose",null,"Percent of subjects with greater than or equal to 20% reduction of ALP|Percent of subjects with greater than or equal to 30% reduction of ALP|Percent of subjects with greater than or equal to 40% reduction of ALP|Percent change of liver enzymes|Percent change of selected biomarkers","through 4 weeks of dosing until 56 days post-dose",null,"gwenaelle.mille@durect.com","Gwenaelle Mille","408-777-1417","San Francisco, California, United States, 94115","California","United States","California Pacific Medical Center",{"$nulls":3},"Alastair Smith, MD","2018-01-08","2020-05-25T16:35:58.254","2020-05-26T17:10:42.972","NCT03394781"]
["5ecbf3eee2561b1b11905cfa","NCT03394781","2018-01-25","Durect","DRRX","Recruiting","A Research Study to Evaluate Safety and Efficacy of DUR-928 in Subjects With Primary Sclerosing Cholangitis (PSC)","Dur-928",null,"Yes","['Dur-928']","Unknown",null,"Phase 2",2,40,"Anticipated","2018-01-01","2019-01-01",{"$nulls":5},"This is a research trial testing DUR-928 (an experimental medication). The purpose of the trial is to assess whether treatment with DUR-928 has any effect on the treatment of Primary Sclerosing Cholangitis (PSC). This trial will also assess safety (side effects).",null,"A Randomized, Open-label, Phase 2 Study to Evaluate Safety and Efficacy of DUR-928 in Subjects With Primary Sclerosing Cholangitis (PSC)","C928-008","Primary Sclerosing Cholangitis","Cholangitis|Cholangitis, Sclerosing","Biliary Tract Diseases","Gastrointestinal","Experimental","DUR-928 10 mg|DUR-928 50 mg","10 mg oral suspension|50 mg oral suspension","Drug","DUR-928","oral suspension daily for 28 days",null,"DUR-928 10 mg|DUR-928 50 mg","\n\n * Verified diagnosis of PSC for at least 12 months, with or without IBD.\n * Serum (ALP) â‰¥ 1.5 times ULN and with no >15% fluctuation in the past 3 months.\n * In subjects receiving treatment with ursodeoxycholic acid (UDCA), therapy must be stable for at least 3 months and at a dose not greater than 20 mg/kg/day.\n * Subjects of childbearing potential must agree to use a medically acceptable method of contraceptive to prevent pregnancy in the subject and/or the partner for the duration of their participation in the trial up to 2 months after the last study drug dosing.\n\n","\n\n * Presence of documented secondary sclerosing cholangitis or small duct PSC\n * Bacterial cholangitis within 30 days prior to Screening\n * Presence of percutaneous drain or endoscopic bile duct stent\n * History of, or suspicion of cholangiocarcinoma.\n * Prior liver transplantation, or currently listed for liver transplantation\n * Presence of other concomitant liver diseases\n * Moderate to Severe active IBD or flare in colitis activity within the last 3 months\n * Any severe and/or untreated concomitant cardiovascular, renal, endocrine or psychiatric disorder\n * Any active malignant disease (within 3 years), other than non-melanomatous skin cancer\n * Human immunodeficiency virus (HIV) infection\n * Existing or intended pregnancy, or breast feeding\n * Has received medication from another clinical trial within the past 30 days",{"$nulls":4},"Actual","2018-01-09","Actual","Anticipated","2019-01-01","Anticipated","2018-01-01","2018-01-03","2018-01-08","2018-01-22","No",null,"Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years","80 Years","All",null,"No","Undecided",{"$nulls":3},"Yes","No",{"$nulls":19},"Number of participants with treatment-related adverse events as assessed by CTCAE v4.0|Percent change of ALP from baseline","through 4 weeks of dosing until 56 days post-dose",null,"Percent change of liver enzymes|Percent change of selected biomarkers","through 4 weeks of dosing until 56 days post-dose",null,"gwenaelle.mille@durect.com","Gwenaelle Mille","408-777-1417","Palo Alto, California, United States, 94304 California Pacific Medical CenterSan Francisco, California, United States, 94115|Aurora, Colorado, United States, 80045 United States, District Of Columbia Georgetown UniversityWashington, District Of Columbia, United States, 20057|Coral Gables, Florida, United States, 33146 Mayo Clinic FloridaJacksonville, Florida, United States, 32224|Jackson, Missouri, United States, 39216|Charlotte, North Carolina, United States, 28203|San Antonio, Texas, United States, 78215","California|Colorado|Florida|Missouri|North Carolina|Texas","United States","Stanford University|University Of Colorado|University Of Miami|Southern Therapy And Advanced Research|Charlotte Mecklenburg Hospital|Texas Liver Institute",{"$nulls":3},"Alastair Smith, MD","2018-01-22","2020-05-25T16:35:58.328","2020-05-26T17:10:42.972","NCT03394781"]
["5ecbf3eefe30261b1a0481ff","NCT03394781","2018-01-29","Durect","DRRX","Recruiting","A Research Study to Evaluate Safety and Efficacy of DUR-928 in Subjects With Primary Sclerosing Cholangitis (PSC)","Dur-928",null,"Yes","['Dur-928']","Unknown",null,"Phase 2",2,40,"Anticipated","2018-01-01","2019-01-01",{"$nulls":5},"This is a research trial testing DUR-928 (an experimental medication). The purpose of the trial is to assess whether treatment with DUR-928 has any effect on the treatment of Primary Sclerosing Cholangitis (PSC). This trial will also assess safety (side effects).",null,"A Randomized, Open-label, Phase 2 Study to Evaluate Safety and Efficacy of DUR-928 in Subjects With Primary Sclerosing Cholangitis (PSC)","C928-008","Primary Sclerosing Cholangitis","Cholangitis|Cholangitis, Sclerosing","Biliary Tract Diseases","Gastrointestinal","Experimental","DUR-928 10 mg|DUR-928 50 mg","10 mg oral suspension|50 mg oral suspension","Drug","DUR-928","oral suspension daily for 28 days",null,"DUR-928 10 mg|DUR-928 50 mg","\n\n * Verified diagnosis of PSC for at least 12 months, with or without IBD.\n * Serum (ALP) â‰¥ 1.5 times ULN and with no >15% fluctuation in the past 3 months.\n * In subjects receiving treatment with ursodeoxycholic acid (UDCA), therapy must be stable for at least 3 months and at a dose not greater than 20 mg/kg/day.\n * Subjects of childbearing potential must agree to use a medically acceptable method of contraceptive to prevent pregnancy in the subject and/or the partner for the duration of their participation in the trial up to 2 months after the last study drug dosing.\n\n","\n\n * Presence of documented secondary sclerosing cholangitis or small duct PSC\n * Bacterial cholangitis within 30 days prior to Screening\n * Presence of percutaneous drain or endoscopic bile duct stent\n * History of, or suspicion of cholangiocarcinoma.\n * Prior liver transplantation, or currently listed for liver transplantation\n * Presence of other concomitant liver diseases\n * Moderate to Severe active IBD or flare in colitis activity within the last 3 months\n * Any severe and/or untreated concomitant cardiovascular, renal, endocrine or psychiatric disorder\n * Any active malignant disease (within 3 years), other than non-melanomatous skin cancer\n * Human immunodeficiency virus (HIV) infection\n * Existing or intended pregnancy, or breast feeding\n * Has received medication from another clinical trial within the past 30 days",{"$nulls":4},"Actual","2018-01-09","Actual","Anticipated","2019-01-01","Anticipated","2018-01-01","2018-01-03","2018-01-08","2018-01-25","No",null,"Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years","80 Years","All",null,"No","Undecided",{"$nulls":3},"Yes","No",{"$nulls":19},"Number of participants with treatment-related adverse events as assessed by CTCAE v4.0|Percent change of ALP from baseline","through 4 weeks of dosing until 56 days post-dose",null,"Percent change of liver enzymes|Percent change of selected biomarkers","through 4 weeks of dosing until 56 days post-dose",null,"gwenaelle.mille@durect.com","Gwenaelle Mille","408-777-1417","Palo Alto, California, United States, 94304 California Pacific Medical CenterSan Francisco, California, United States, 94115|Aurora, Colorado, United States, 80045 United States, District Of Columbia Georgetown UniversityWashington, District Of Columbia, United States, 20057|Coral Gables, Florida, United States, 33146 Mayo Clinic FloridaJacksonville, Florida, United States, 32224|Jackson, Mississippi, United States, 39216|Charlotte, North Carolina, United States, 28203|San Antonio, Texas, United States, 78215","California|Colorado|Florida|Mississippi|North Carolina|Texas","United States","Stanford University|University Of Colorado|University Of Miami|Southern Therapy And Advanced Research|Charlotte Mecklenburg Hospital|Texas Liver Institute",{"$nulls":3},"Alastair Smith, MD","2018-01-25","2020-05-25T16:35:58.424","2020-05-26T17:10:42.972","NCT03394781"]
["5ecbf3eefe30261b1a048200","NCT03394781","2018-02-05","Durect","DRRX","Recruiting","A Research Study to Evaluate Safety and Efficacy of DUR-928 in Subjects With Primary Sclerosing Cholangitis (PSC)","Dur-928",null,"Yes","['Dur-928']","Unknown",null,"Phase 2",2,40,"Anticipated","2018-01-22","2019-01-01",{"$nulls":5},"This is a research trial testing DUR-928 (an experimental medication). The purpose of the trial is to assess whether treatment with DUR-928 has any effect on the treatment of Primary Sclerosing Cholangitis (PSC). This trial will also assess safety (side effects).",null,"A Randomized, Open-label, Phase 2 Study to Evaluate Safety and Efficacy of DUR-928 in Subjects With Primary Sclerosing Cholangitis (PSC)","C928-008","Primary Sclerosing Cholangitis","Cholangitis|Cholangitis, Sclerosing","Biliary Tract Diseases","Gastrointestinal","Experimental","DUR-928 10 mg|DUR-928 50 mg","10 mg oral suspension|50 mg oral suspension","Drug","DUR-928","oral suspension daily for 28 days",null,"DUR-928 10 mg|DUR-928 50 mg","\n\n * Verified diagnosis of PSC for at least 12 months, with or without IBD.\n * Serum (ALP) â‰¥ 1.5 times ULN and with no >15% fluctuation in the past 3 months.\n * In subjects receiving treatment with ursodeoxycholic acid (UDCA), therapy must be stable for at least 3 months and at a dose not greater than 20 mg/kg/day.\n * Subjects of childbearing potential must agree to use a medically acceptable method of contraceptive to prevent pregnancy in the subject and/or the partner for the duration of their participation in the trial up to 2 months after the last study drug dosing.\n\n","\n\n * Presence of documented secondary sclerosing cholangitis or small duct PSC\n * Bacterial cholangitis within 30 days prior to Screening\n * Presence of percutaneous drain or endoscopic bile duct stent\n * History of, or suspicion of cholangiocarcinoma.\n * Prior liver transplantation, or currently listed for liver transplantation\n * Presence of other concomitant liver diseases\n * Moderate to Severe active IBD or flare in colitis activity within the last 3 months\n * Any severe and/or untreated concomitant cardiovascular, renal, endocrine or psychiatric disorder\n * Any active malignant disease (within 3 years), other than non-melanomatous skin cancer\n * Human immunodeficiency virus (HIV) infection\n * Existing or intended pregnancy, or breast feeding\n * Has received medication from another clinical trial within the past 30 days",{"$nulls":4},"Actual","2018-01-09","Actual","Anticipated","2019-01-01","Anticipated","2018-02-01","2018-01-03","2018-01-08","2018-02-01","No",null,"Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years","80 Years","All",null,"No","Undecided",{"$nulls":3},"Yes","No",{"$nulls":19},"Number of participants with treatment-related adverse events as assessed by CTCAE v4.0|Percent change of ALP from baseline","through 4 weeks of dosing until 56 days post-dose",null,"Percent change of liver enzymes|Percent change of selected biomarkers","through 4 weeks of dosing until 56 days post-dose",null,"gwenaelle.mille@durect.com","Gwenaelle Mille","408-777-1417","Palo Alto, California, United States, 94304 California Pacific Medical CenterSan Francisco, California, United States, 94115|Aurora, Colorado, United States, 80045 United States, District Of Columbia Georgetown UniversityWashington, District Of Columbia, United States, 20057|Coral Gables, Florida, United States, 33146 Mayo Clinic FloridaJacksonville, Florida, United States, 32224|Jackson, Mississippi, United States, 39216|Charlotte, North Carolina, United States, 28203|San Antonio, Texas, United States, 78215","California|Colorado|Florida|Mississippi|North Carolina|Texas","United States","Stanford University|University Of Colorado|University Of Miami|Southern Therapy And Advanced Research|Charlotte Mecklenburg Hospital|Texas Liver Institute",{"$nulls":3},"Alastair Smith, MD","2018-02-01","2020-05-25T16:35:58.861","2020-05-26T17:10:42.972","NCT03394781"]
["5ecbf3ee11702c1b1b916a11","NCT03394781","2018-04-19","Durect","DRRX","Recruiting","A Research Study to Evaluate Safety and Efficacy of DUR-928 in Subjects With Primary Sclerosing Cholangitis (PSC)","Dur-928",null,"Yes","['Dur-928']","Unknown",null,"Phase 2",2,40,"Anticipated","2018-01-22","2019-01-01",{"$nulls":5},"This is a research trial testing DUR-928 (an experimental medication). The purpose of the trial is to assess whether treatment with DUR-928 has any effect on the treatment of Primary Sclerosing Cholangitis (PSC). This trial will also assess safety (side effects).",null,"A Randomized, Open-label, Phase 2 Study to Evaluate Safety and Efficacy of DUR-928 in Subjects With Primary Sclerosing Cholangitis (PSC)","C928-008","Primary Sclerosing Cholangitis","Cholangitis|Cholangitis, Sclerosing","Biliary Tract Diseases","Gastrointestinal","Experimental","DUR-928 10 mg|DUR-928 50 mg","10 mg oral suspension|50 mg oral suspension","Drug","DUR-928","oral suspension daily for 28 days",null,"DUR-928 10 mg|DUR-928 50 mg","\n\n * Verified diagnosis of PSC for at least 12 months, with or without IBD.\n * Serum (ALP) â‰¥ 1.5 times ULN and with no >15% fluctuation in the past 3 months.\n * In subjects receiving treatment with ursodeoxycholic acid (UDCA), therapy must be stable for at least 3 months and at a dose not greater than 20 mg/kg/day.\n * Subjects of childbearing potential must agree to use a medically acceptable method of contraceptive to prevent pregnancy in the subject and/or the partner for the duration of their participation in the trial up to 2 months after the last study drug dosing.\n\n","\n\n * Presence of documented secondary sclerosing cholangitis or small duct PSC\n * Bacterial cholangitis within 30 days prior to Screening\n * Presence of percutaneous drain or endoscopic bile duct stent\n * History of, or suspicion of cholangiocarcinoma.\n * Prior liver transplantation, or currently listed for liver transplantation\n * Presence of other concomitant liver diseases\n * Moderate to Severe active IBD or flare in colitis activity within the last 3 months\n * Any severe and/or untreated concomitant cardiovascular, renal, endocrine or psychiatric disorder\n * Any active malignant disease (within 3 years), other than non-melanomatous skin cancer\n * Human immunodeficiency virus (HIV) infection\n * Existing or intended pregnancy, or breast feeding\n * Has received medication from another clinical trial within the past 30 days",{"$nulls":4},"Actual","2018-01-09","Actual","Anticipated","2019-01-01","Anticipated","2018-04-01","2018-01-03","2018-01-08","2018-04-18","No",null,"Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years","80 Years","All",null,"No","Undecided",{"$nulls":3},"Yes","No",{"$nulls":19},"Number of participants with treatment-related adverse events as assessed by CTCAE v4.0|Percent change of ALP from baseline","through 4 weeks of dosing until 56 days post-dose",null,"Percent change of liver enzymes|Percent change of selected biomarkers","through 4 weeks of dosing until 56 days post-dose",null,"gwenaelle.mille@durect.com","Gwenaelle Mille","408-777-1417","Palo Alto, California, United States, 94304 California Pacific Medical CenterSan Francisco, California, United States, 94115|Aurora, Colorado, United States, 80045 United States, District Of Columbia Georgetown UniversityWashington, District Of Columbia, United States, 20057|Coral Gables, Florida, United States, 33146 Mayo Clinic FloridaJacksonville, Florida, United States, 32224|Jackson, Mississippi, United States, 39216|Charlotte, North Carolina, United States, 28203|San Antonio, Texas, United States, 78215","California|Colorado|Florida|Mississippi|North Carolina|Texas","United States","Stanford University|University Of Colorado|University Of Miami|Southern Therapy And Advanced Research|Charlotte Mecklenburg Hospital|Texas Liver Institute",{"$nulls":3},"Alastair Smith, MD","2018-04-18","2020-05-25T16:35:58.554","2020-05-26T17:10:42.972","NCT03394781"]
["5ecbf3eefeab101b1553082f","NCT03394781","2018-06-07","Durect","DRRX","Recruiting","A Research Study to Evaluate Safety and Efficacy of DUR-928 in Subjects With Primary Sclerosing Cholangitis (PSC)","Dur-928",null,"Yes","['Dur-928']","Unknown",null,"Phase 2",2,40,"Anticipated","2018-01-22","2019-01-01",{"$nulls":5},"This is a research trial testing DUR-928 (an experimental medication). The purpose of the trial is to assess whether treatment with DUR-928 has any effect on the treatment of Primary Sclerosing Cholangitis (PSC). This trial will also assess safety (side effects).",null,"A Randomized, Open-label, Phase 2 Study to Evaluate Safety and Efficacy of DUR-928 in Subjects With Primary Sclerosing Cholangitis (PSC)","C928-008","Primary Sclerosing Cholangitis","Cholangitis|Cholangitis, Sclerosing","Biliary Tract Diseases","Gastrointestinal","Experimental","DUR-928 10 mg|DUR-928 50 mg","10 mg oral suspension|50 mg oral suspension","Drug","DUR-928","oral suspension daily for 28 days",null,"DUR-928 10 mg|DUR-928 50 mg","\n\n * Verified diagnosis of PSC for at least 12 months, with or without IBD.\n * Serum (ALP) â‰¥ 1.5 times ULN and with no >15% fluctuation in the past 3 months.\n * In subjects receiving treatment with ursodeoxycholic acid (UDCA), therapy must be stable for at least 3 months and at a dose not greater than 20 mg/kg/day.\n * Subjects of childbearing potential must agree to use a medically acceptable method of contraceptive to prevent pregnancy in the subject and/or the partner for the duration of their participation in the trial up to 2 months after the last study drug dosing.\n\n","\n\n * Presence of documented secondary sclerosing cholangitis or small duct PSC\n * Bacterial cholangitis within 30 days prior to Screening\n * Presence of percutaneous drain or endoscopic bile duct stent\n * History of, or suspicion of cholangiocarcinoma.\n * Prior liver transplantation, or currently listed for liver transplantation\n * Presence of other concomitant liver diseases\n * Moderate to Severe active IBD or flare in colitis activity within the last 3 months\n * Any severe and/or untreated concomitant cardiovascular, renal, endocrine or psychiatric disorder\n * Any active malignant disease (within 3 years), other than non-melanomatous skin cancer\n * Human immunodeficiency virus (HIV) infection\n * Existing or intended pregnancy, or breast feeding\n * Has received medication from another clinical trial within the past 30 days",{"$nulls":4},"Actual","2018-01-09","Actual","Anticipated","2019-01-01","Anticipated","2018-06-01","2018-01-03","2018-01-08","2018-06-06","No",null,"Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years","80 Years","All",null,"No","Undecided",{"$nulls":3},"Yes","No",{"$nulls":19},"Number of participants with treatment-related adverse events as assessed by CTCAE v4.0|Percent change of ALP from baseline","through 4 weeks of dosing until 56 days post-dose",null,"Percent change of liver enzymes|Percent change of selected biomarkers","through 4 weeks of dosing until 56 days post-dose",null,"gwenaelle.mille@durect.com","Gwenaelle Mille","408-777-1417","Palo Alto, California, United States, 94304 California Pacific Medical CenterSan Francisco, California, United States, 94115|Aurora, Colorado, United States, 80045|Coral Gables, Florida, United States, 33146 Mayo Clinic FloridaJacksonville, Florida, United States, 32224|Boston, Massachusetts, United States, 02114 Lahey ClinicBurlington, Massachusetts, United States, 01803|Jackson, Mississippi, United States, 39216|Charlotte, North Carolina, United States, 28203|San Antonio, Texas, United States, 78215","California|Colorado|Florida|Massachusetts|Mississippi|North Carolina|Texas","United States","Stanford University|University Of Colorado|University Of Miami|Massachusetts General Hospital|Southern Therapy And Advanced Research|Charlotte Mecklenburg Hospital|Texas Liver Institute",{"$nulls":3},"Alastair Smith, MD","2018-06-06","2020-05-25T16:35:58.552","2020-05-26T17:10:42.972","NCT03394781"]
["5ecbf3ee307e3d1b1f8d9c90","NCT03394781","2019-07-18","Durect","DRRX","Terminated","A Research Study to Evaluate Safety and Efficacy of DUR-928 in Subjects With Primary Sclerosing Cholangitis (PSC)","Dur-928",null,"Yes","['Dur-928']","Unknown",null,"Phase 2",2,5,"Actual","2018-01-22","2019-01-31",{"$nulls":5},"This is a research trial testing DUR-928 (an experimental medication). The purpose of the trial is to assess whether treatment with DUR-928 has any effect on the treatment of Primary Sclerosing Cholangitis (PSC). This trial will also assess safety (side effects).",null,"A Randomized, Open-label, Phase 2 Study to Evaluate Safety and Efficacy of DUR-928 in Subjects With Primary Sclerosing Cholangitis (PSC)","C928-008","Primary Sclerosing Cholangitis","Cholangitis|Cholangitis, Sclerosing","Biliary Tract Diseases","Gastrointestinal","Experimental","DUR-928 10 mg|DUR-928 50 mg","10 mg oral suspension|50 mg oral suspension","Drug","DUR-928","oral suspension daily for 28 days",null,"DUR-928 10 mg|DUR-928 50 mg","\n\n * Verified diagnosis of PSC for at least 12 months, with or without IBD.\n * Serum (ALP) â‰¥ 1.5 times ULN and with no >15% fluctuation in the past 3 months.\n * In subjects receiving treatment with ursodeoxycholic acid (UDCA), therapy must be stable for at least 3 months and at a dose not greater than 20 mg/kg/day.\n * Subjects of childbearing potential must agree to use a medically acceptable method of contraceptive to prevent pregnancy in the subject and/or the partner for the duration of their participation in the trial up to 2 months after the last study drug dosing.\n\n","\n\n * Presence of documented secondary sclerosing cholangitis or small duct PSC\n * Bacterial cholangitis within 30 days prior to Screening\n * Presence of percutaneous drain or endoscopic bile duct stent\n * History of, or suspicion of cholangiocarcinoma.\n * Prior liver transplantation, or currently listed for liver transplantation\n * Presence of other concomitant liver diseases\n * Moderate to Severe active IBD or flare in colitis activity within the last 3 months\n * Any severe and/or untreated concomitant cardiovascular, renal, endocrine or psychiatric disorder\n * Any active malignant disease (within 3 years), other than non-melanomatous skin cancer\n * Human immunodeficiency virus (HIV) infection\n * Existing or intended pregnancy, or breast feeding\n * Has received medication from another clinical trial within the past 30 days",{"$nulls":4},"Actual","2018-01-09","Actual","Actual","2019-01-31","Actual","2019-07-01","2018-01-03","2018-01-08","2019-07-16","No",null,"Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years","80 Years","All",null,"No","Undecided",{"$nulls":3},"Yes","No",{"$nulls":19},"Number of participants with treatment-related adverse events as assessed by CTCAE v4.0|Percent change of ALP from baseline","through 4 weeks of dosing until 56 days post-dose",null,"Percent change of liver enzymes|Percent change of selected biomarkers","through 4 weeks of dosing until 56 days post-dose",{"$nulls":4},"San Francisco, California, United States, 94115|Jacksonville, Florida, United States, 32224|Jackson, Mississippi, United States, 39216|Charlotte, North Carolina, United States, 28203","California|Florida|Mississippi|North Carolina","United States","California Pacific Medical Center|Mayo Clinic Florida|Southern Therapy And Advanced Research|Charlotte Mecklenburg Hospital",{"$nulls":3},"Alastair Smith, MD","2019-07-16","2020-05-25T16:35:58.646","2020-05-26T17:10:42.972","NCT03394781"]
["5ecbf3efe2561b1b11905cfc","NCT03394924","2018-01-09","Enanta Pharmaceuticals","ENTA","Recruiting","A Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Primary Biliary Cholangitis","Edp-305","FXR Agonist","Yes","['Edp-305']","No",null,"Phase 2",3,119,"Anticipated","2017-12-27","2019-01-01",null,null,"Pharmaceutical Research Associates|Pharmaceutical Research Associates\nTriangle Biostatistics","Other",null,"A randomized, double-blind study to assess the safety, tolerability, PK and efficacy of EDP-305 in subjects with primary biliary cholangitis",null,"A Phase 2 Dose Ranging, Randomized, Double Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Primary Biliary Cholangitis (PBC) With or Without an Inadequate Response to Ursodeoxycholic Acid (UDCA)","EDP 305-201","Primary Biliary Cholangitis","Cholangitis","Biliary Tract Diseases","Gastrointestinal","Experimental|Placebo Comparator","EDP-305 Dose 1|EDP-305 Dose 2|Placebo","Subjects will take 2 tablets once a day orally for 12 weeks|Subjects will take two tablets once a day orally for 12 weeks","Drug","EDP-305 Dose 1|EDP-305 Dose 2|Placebo","Two tablets daily for 12 weeks",null,"EDP-305 Dose 1|EDP-305 Dose 2|Placebo","\n\n * An informed consent document signed and dated by the subject.\n * Male and female subjects of any ethnic origin between the ages of 18 and 75 years, inclusive\n * Male or female with a diagnosis of PBC by at least two of the following criteria: * History of ALP above ULN for at least six months\n    * Positive Anti-Mitochondrial Antibodies (AMA) titers (>1/40 on immunofluorescence or M2 positive by enzyme linked immunosorbent assay (ELISA) or positive PBC-specific antinuclear antibodies)\n   \n   \n * For subjects with no documented liver biopsy performed within 2 years, subjects must undergo a transient elastography (Fibroscan) showing liver stiffness < 12.5 kPA\n * Must be on a stable dose of UDCA12-20 mg/kg/day for at least 6 months prior to Screening or intolerant of UDCA in the opinion of the Investigator (no UDCA for at least 12 weeks prior to Screening)\n * Alkaline Phosphatase (ALP) â‰¥ 1.67 Ã— ULN and/or total bilirubin >ULN but < 2Ã—ULN\n * Subjects must have Screening laboratory values for Hepatitis B surface antigen (HBsAg), Hepatitis C surface antigen (HCsAg) and Human Immunodeficiency Virus (HIV) 1 and 2 antibodies (Ab) as seronegative. Note: subjects previously infected by chronic hepatitis C and treated with direct acting antivirals (DAAs) with sustained virologic response (SVR) for at least 3 years will be allowed.\n * Female subjects of childbearing potential must agree to use two effective methods of contraception from the date of Screening until 90 days after the last dose of EDP-305.\n * All male participants who have not had a vasectomy must use effective contraception from Day -1 to 90 days after their last dose of study drug.\n * Male subjects must agree to refrain from sperm donation from the date of Screening until 90 days after their last dose of study drug\n * Screening body mass index (BMI) of 18 to 30 kg/m2 with a minimum body weight of 50 kg\n * Subject must be willing and able to adhere to the assessments, visit schedule, prohibitions and restrictions, as described in this protocol\n\n","\n\n * Laboratory Screening Results: * AST >5 ULN\n    * ALT >5 ULN\n    * Total bilirubin >1.8 mg/dL: NOTE: Patients with Gilbert's syndrome will not be allowed due to interpretability of bilirubin levels\n    * Total white blood cells (WBC) <3000 cells/mm3\n    * Absolute neutrophil count (ANC) <1500 cells/mm3\n    * Platelet count <140,000/mm3\n    * Prothrombin time (international normalized ratio, INR) >1.2\n    * Creatine kinase above upper limit of normal (ULN) except when in relation with intense exercise\n    * Serum creatinine >2 mg/dL or creatinine clearance <60 mL/min (based on Cockroft-Gault Method)\n   \n   \n * Body mass index (BMI) >30 or suspected to have relevant nonalcoholic fatty liver disease (NAFLD) as based on the judgment of the Investigator at Screening\n * Use of colchicine, methotrexate, azathioprine, or systemic steroids in the two months preceding screening\n * Current use of fibrates, including fenofibrates and statins (eg, simvastatin). Note: Subjects who discontinued fibrates for at least 3 months before screening can participate\n * Use of an experimental treatment for PBC within the past 12 months\n * Co-existing liver or biliary diseases, such as primary sclerosing cholangitis, choledocholithiasis, acute or chronic hepatitis, autoimmune hepatitis, alcoholic liver disease, nonalcoholic steatohepatitis (NASH), acute infection of bile duct system or gall bladder, history of gastrointestinal bleeding (secondary to portal hypertension), cirrhosis, cholangiocarcinoma diagnosed or suspected liver cancers\n * Cirrhosis with or without complications, including history or presence of: spontaneous bacterial peritonitis, hepatocellular carcinoma, bilirubin > 2x ULN\n * Hepatorenal syndrome (type I or II) or Screening serum creatinine > 2 mg/dL (178 Î¼mol/L)\n * Prior variceal hemorrhage, uncontrolled encephalopathy, Child-Pugh Class A, B and C, esophageal varices, or refractory ascites within the previous 6 months of Screening (defined as date informed consent signed)\n * Medical conditions that may cause nonhepatic increases in ALP (e.g., Paget's disease)",{"$nulls":4},"Actual","2018-01-09","Actual","Anticipated","2019-01-01","Anticipated","2018-01-01","2017-12-23","2018-01-03","2018-01-03","Yes","PBC\nPrimary Ciliary Cholangitis (PBC)","Interventional","Treatment","Parallel Assignment","Triple (Participant, Care Provider, Investigator)","Randomized","18 Years","75 Years","All",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":19},"Proportion of subjects with at least 20% reduction in ALP from pre-treatment value or normalization of ALP at Week 12","Measurement at Week 12",null,"Safety as measured by â€¢ Frequency of adverse events (AEs), serious AEs, and AEs leading to discontinuation through Week 12|Change from baseline in Bilirubin|Change from Baseline in Alanine aminotransferase (ALT)|Change from Baseline in Aspartate aminotransferase (AST)|Change from Baseline in Gamma-Glutamyl transferase (GGT)|Change from Baseline of Enhanced Liver Fibrosis [ELF] panel|Change from Baseline of PRO C3|Change from Baseline of AST to Platelet Ratio Index [APRI]|Change from Baseline of fibrosis-4 [FIB-4])|Change from Baseline in Triglycerides (TG)|Change from Baseline in Total Cholesterol (TC)|Change from Baseline in High Density Lipoprotein Cholesterol (HDL-C)|Change from Baseline in Low Density Lipoprotein Cholesterol (LDL-C)|Change from Baseline in 5D-itch scale|Change from Baseline in Visual Analog Score (VAS)|Change from Baseline in PBC-40 Quality of Life (QoL)|Cmax of EDP-305|Tmax of EDP-305|AUC of EDP-305|Change from baseline of FGF19|Change from baseline of C4|Change from baseline of Total Bile Acids","Up to 12 weeks|Measurement at Week 12|Up to Week 12",null,"nadda@enanta.com","Nathalie Adda","617 607 0705","Rialto, California, United States, 92377|San Antonio, Texas, United States, 78215","California|Texas","United States","Inland Empire Liver Foundation|American Research Corporation At The Texas Liver Institute",{"$nulls":4},"2018-01-03","2020-05-25T16:35:59.249","2020-05-26T17:10:42.972","NCT03394924"]
["5ecbf3efe2561b1b11905cfd","NCT03394924","2018-03-21","Enanta Pharmaceuticals","ENTA","Recruiting","A Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Primary Biliary Cholangitis","Edp-305","FXR Agonist","Yes","['Edp-305']","No",null,"Phase 2",3,119,"Anticipated","2017-12-27","2019-03-01",null,null,"Pharmaceutical Research Associates|Pharmaceutical Research Associates\nTriangle Biostatistics","Other",null,"A randomized, double-blind study to assess the safety, tolerability, PK and efficacy of EDP-305 in subjects with primary biliary cholangitis",null,"A Phase 2 Dose Ranging, Randomized, Double Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Primary Biliary Cholangitis (PBC) With or Without an Inadequate Response to Ursodeoxycholic Acid (UDCA)","EDP 305-201","Primary Biliary Cholangitis","Cholangitis","Biliary Tract Diseases","Gastrointestinal","Experimental|Placebo Comparator","EDP-305 Dose 1|EDP-305 Dose 2|Placebo","Subjects will take 2 tablets once a day orally for 12 weeks|Subjects will take two tablets once a day orally for 12 weeks","Drug","EDP-305 Dose 1|EDP-305 Dose 2|Placebo","Two tablets daily for 12 weeks",null,"EDP-305 Dose 1|EDP-305 Dose 2|Placebo","\n\n * An informed consent document signed and dated by the subject.\n * Male and female subjects of any ethnic origin between the ages of 18 and 75 years, inclusive\n * Male or female with a diagnosis of PBC by at least two of the following criteria: * History of ALP above ULN for at least six months\n    * Positive Anti-Mitochondrial Antibodies (AMA) titers (>1/40 on immunofluorescence or M2 positive by enzyme linked immunosorbent assay (ELISA) or positive PBC-specific antinuclear antibodies)\n   \n   \n * For subjects with no documented liver biopsy performed within 2 years, subjects must undergo a transient elastography (Fibroscan) showing liver stiffness < 12.5 kPA\n * Must be on a stable dose of UDCA12-20 mg/kg/day for at least 6 months prior to Screening or intolerant of UDCA in the opinion of the Investigator (no UDCA for at least 12 weeks prior to Screening)\n * Alkaline Phosphatase (ALP) â‰¥ 1.67 Ã— ULN and/or total bilirubin >ULN but < 2Ã—ULN\n * Subjects must have Screening laboratory values for Hepatitis B surface antigen (HBsAg), Hepatitis C surface antigen (HCsAg) and Human Immunodeficiency Virus (HIV) 1 and 2 antibodies (Ab) as seronegative. Note: subjects previously infected by chronic hepatitis C and treated with direct acting antivirals (DAAs) with sustained virologic response (SVR) for at least 3 years will be allowed.\n * Female subjects of childbearing potential must agree to use two effective methods of contraception from the date of Screening until 90 days after the last dose of EDP-305.\n * All male participants who have not had a vasectomy must use effective contraception from Day -1 to 90 days after their last dose of study drug.\n * Male subjects must agree to refrain from sperm donation from the date of Screening until 90 days after their last dose of study drug\n * Screening body mass index (BMI) of 18 to 30 kg/m2 with a minimum body weight of 50 kg\n * Subject must be willing and able to adhere to the assessments, visit schedule, prohibitions and restrictions, as described in this protocol\n\n","\n\n * Laboratory Screening Results: * AST >5 ULN\n    * ALT >5 ULN\n    * Total bilirubin >1.8 mg/dL: NOTE: Patients with Gilbert's syndrome will not be allowed due to interpretability of bilirubin levels\n    * Total white blood cells (WBC) <3000 cells/mm3\n    * Absolute neutrophil count (ANC) <1500 cells/mm3\n    * Platelet count <140,000/mm3\n    * Prothrombin time (international normalized ratio, INR) >1.2\n    * Creatine kinase above upper limit of normal (ULN) except when in relation with intense exercise\n    * Serum creatinine >2 mg/dL or creatinine clearance <60 mL/min (based on Cockroft-Gault Method)\n   \n   \n * Body mass index (BMI) >30 or suspected to have relevant nonalcoholic fatty liver disease (NAFLD) as based on the judgment of the Investigator at Screening\n * Use of colchicine, methotrexate, azathioprine, or systemic steroids in the two months preceding screening\n * Current use of fibrates, including fenofibrates and statins (eg, simvastatin). Note: Subjects who discontinued fibrates for at least 3 months before screening can participate\n * Use of an experimental treatment for PBC within the past 12 months\n * Co-existing liver or biliary diseases, such as primary sclerosing cholangitis, choledocholithiasis, acute or chronic hepatitis, autoimmune hepatitis, alcoholic liver disease, nonalcoholic steatohepatitis (NASH), acute infection of bile duct system or gall bladder, history of gastrointestinal bleeding (secondary to portal hypertension), cirrhosis, cholangiocarcinoma diagnosed or suspected liver cancers\n * Cirrhosis with or without complications, including history or presence of: spontaneous bacterial peritonitis, hepatocellular carcinoma, bilirubin > 2x ULN\n * Hepatorenal syndrome (type I or II) or Screening serum creatinine > 2 mg/dL (178 Î¼mol/L)\n * Prior variceal hemorrhage, uncontrolled encephalopathy, Child-Pugh Class A, B and C, esophageal varices, or refractory ascites within the previous 6 months of Screening (defined as date informed consent signed)\n * Medical conditions that may cause nonhepatic increases in ALP (e.g., Paget's disease)",{"$nulls":4},"Actual","2018-01-09","Actual","Anticipated","2019-04-01","Anticipated","2018-03-01","2017-12-23","2018-01-03","2018-03-19","Yes","PBC\nPrimary Ciliary Cholangitis (PBC)","Interventional","Treatment","Parallel Assignment","Triple (Participant, Care Provider, Investigator)","Randomized","18 Years","75 Years","All",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":19},"Proportion of subjects with at least 20% reduction in ALP from pre-treatment value or normalization of ALP at Week 12","Measurement at Week 12",null,"Safety as measured by â€¢ Frequency of adverse events (AEs), serious AEs, and AEs leading to discontinuation through Week 12|Change from baseline in Bilirubin|Change from Baseline in Alanine aminotransferase (ALT)|Change from Baseline in Aspartate aminotransferase (AST)|Change from Baseline in Gamma-Glutamyl transferase (GGT)|Change from Baseline of Enhanced Liver Fibrosis [ELF] panel|Change from Baseline of PRO C3|Change from Baseline of AST to Platelet Ratio Index [APRI]|Change from Baseline of fibrosis-4 [FIB-4])|Change from Baseline in Triglycerides (TG)|Change from Baseline in Total Cholesterol (TC)|Change from Baseline in High Density Lipoprotein Cholesterol (HDL-C)|Change from Baseline in Low Density Lipoprotein Cholesterol (LDL-C)|Change from Baseline in 5D-itch scale|Change from Baseline in Visual Analog Score (VAS)|Change from Baseline in PBC-40 Quality of Life (QoL)|Cmax of EDP-305|Tmax of EDP-305|AUC of EDP-305|Change from baseline of FGF19|Change from baseline of C4|Change from baseline of Total Bile Acids","Up to 12 weeks|Measurement at Week 12|Up to Week 12",null,"nadda@enanta.com","Nathalie Adda","617 607 0705","Rialto, California, United States, 92377|San Antonio, Texas, United States, 78215","California|Texas","United States","Inland Empire Liver Foundation|American Research Corporation At The Texas Liver Institute",{"$nulls":4},"2018-03-19","2020-05-25T16:35:59.485","2020-05-26T17:10:42.972","NCT03394924"]
["5ecbf3ef11702c1b1b916a13","NCT03394924","2018-11-09","Enanta Pharmaceuticals","ENTA","Recruiting","A Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Primary Biliary Cholangitis","Edp-305","FXR Agonist","Yes","['Edp-305']","No",null,"Phase 2",3,119,"Anticipated","2017-12-27","2019-03-01",null,null,"Pharmaceutical Research Associates|Pharmaceutical Research Associates\nTriangle Biostatistics","Other",null,"A randomized, double-blind study to assess the safety, tolerability, PK and efficacy of EDP-305 in subjects with primary biliary cholangitis",null,"A Phase 2 Dose Ranging, Randomized, Double Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Primary Biliary Cholangitis (PBC) With or Without an Inadequate Response to Ursodeoxycholic Acid (UDCA)","EDP 305-201","Primary Biliary Cholangitis","Cholangitis","Biliary Tract Diseases","Gastrointestinal","Experimental|Placebo Comparator","EDP-305 Dose 1|EDP-305 Dose 2|Placebo","Subjects will take 2 tablets once a day orally for 12 weeks|Subjects will take two tablets once a day orally for 12 weeks","Drug","EDP-305 Dose 1|EDP-305 Dose 2|Placebo","Two tablets daily for 12 weeks",null,"EDP-305 Dose 1|EDP-305 Dose 2|Placebo","\n\n * An informed consent document signed and dated by the subject.\n * Male and female subjects of any ethnic origin between the ages of 18 and 75 years, inclusive\n * Male or female with a diagnosis of PBC by at least two of the following criteria: * History of ALP above ULN for at least six months\n    * Positive Anti-Mitochondrial Antibodies (AMA) titers (>1/40 on immunofluorescence or M2 positive by enzyme linked immunosorbent assay (ELISA) or positive PBC-specific antinuclear antibodies)\n   \n   \n * For subjects with no documented liver biopsy performed within 2 years, subjects must undergo a transient elastography (Fibroscan) showing liver stiffness < 14.0 kPA\n * Must be on a stable dose of UDCA12-20 mg/kg/day for at least 6 months prior to Screening or intolerant of UDCA in the opinion of the Investigator (no UDCA for at least 12 weeks prior to Screening)\n * Alkaline Phosphatase (ALP) â‰¥ 1.67 Ã— ULN and/or total bilirubin >ULN but < 2Ã—ULN (<2.4 mg/dL)\n * Subjects must have Screening laboratory values for Hepatitis B surface antigen (HBsAg), anti-HCV antibodies and HCV RNA negative and Human Immunodeficiency Virus (HIV) 1 and 2 antibodies (Ab) as seronegative. Note: subjects previously infected by chronic hepatitis C and treated with direct acting antivirals (DAAs) with sustained virologic response (SVR) for at least 3 years will be allowed.\n * Female subjects of childbearing potential must agree to use two effective methods of contraception from the date of Screening until 90 days after the last dose of EDP-305.\n * All male participants who have not had a vasectomy must use effective contraception from Day -1 to 90 days after their last dose of study drug.\n * Male subjects must agree to refrain from sperm donation from the date of Screening until 90 days after their last dose of study drug\n * Screening body mass index (BMI) of â‰¥18 kg/m2\n * Subject must be willing and able to adhere to the assessments, visit schedule, prohibitions and restrictions, as described in this protocol\n\n","\n\n * Laboratory Screening Results: * AST >5 x ULN\n    * ALT >5 x ULN\n    * Patients with Gilbert's syndrome will not be allowed due to interpretability of bilirubin levels\n    * Total white blood cells (WBC) <3000 cells/mm3\n    * Absolute neutrophil count (ANC) <1500 cells/mm3\n    * Platelet count <140,000/mm3\n    * Prothrombin time (international normalized ratio, INR) >1.2\n    * Serum creatinine >2 mg/dL or creatinine clearance <60 mL/min (based on Cockroft-Gault Method)\n   \n   \n * Suspected to have relevant nonalcoholic fatty liver disease (NAFLD) as based on the judgment of the Investigator at Screening\n * Use of immunosuppressants known to have an effect on the liver of patients with PBC (eg, colchicine, methotrexate, azathioprine, or systemic steroids) in the three months preceding screening\n * Current use of fibrates, including fenofibrates. Note: Subjects who discontinued fibrates for at least 3 months before Screening can participate\n * Use of an experimental treatment for PBC within the past 6 months\n * Co-existing liver or biliary diseases, such as primary sclerosing cholangitis, choledocholithiasis, acute or chronic hepatitis, autoimmune hepatitis, alcoholic liver disease, nonalcoholic steatohepatitis (NASH), acute infection of bile duct system or gall bladder, history of gastrointestinal bleeding (secondary to portal hypertension), cirrhosis, cholangiocarcinoma diagnosed or suspected liver cancers\n * Cirrhosis with or without complications, including history or presence of: spontaneous bacterial peritonitis, hepatocellular carcinoma\n * Hepatorenal syndrome (type I or II) or Screening serum creatinine > 2 mg/dL (178 Î¼mol/L)\n * Prior variceal hemorrhage, uncontrolled encephalopathy, Child-Pugh Class A, B and C, esophageal varices, or refractory ascites within the previous 6 months of Screening (defined as date informed consent signed)\n * Medical conditions that may cause nonhepatic increases in ALP (e.g., Paget's disease)\n * Use of a new statin regimen from Screening and throughout study duration. NOTE: Subjects on a stable dose of statins for at least 3 months prior to Screening are allowed. No dose modification during the study will be allowed.\n * Use of immunosuppressants (eg, systemic corticosteroids) for more than 2 consecutive weeks in duration within 1 year prior to Screening.",{"$nulls":4},"Actual","2018-01-09","Actual","Anticipated","2019-04-01","Anticipated","2018-03-01","2017-12-23","2018-01-03","2018-11-08","Yes","PBC\nPrimary Ciliary Cholangitis (PBC)","Interventional","Treatment","Parallel Assignment","Triple (Participant, Care Provider, Investigator)","Randomized","18 Years","75 Years","All",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":19},"Proportion of subjects with at least 20% reduction in ALP from pre-treatment value or normalization of ALP at Week 12","Measurement at Week 12",null,"Safety as measured by â€¢ Frequency of adverse events (AEs), serious AEs, and AEs leading to discontinuation through Week 12|Change from baseline in Bilirubin|Change from Baseline in Alanine aminotransferase (ALT)|Change from Baseline in Aspartate aminotransferase (AST)|Change from Baseline in Gamma-Glutamyl transferase (GGT)|Change from Baseline of Enhanced Liver Fibrosis [ELF] panel|Change from Baseline of PRO C3|Change from Baseline of AST to Platelet Ratio Index [APRI]|Change from Baseline of fibrosis-4 [FIB-4])|Change from Baseline in Triglycerides (TG)|Change from Baseline in Total Cholesterol (TC)|Change from Baseline in High Density Lipoprotein Cholesterol (HDL-C)|Change from Baseline in Low Density Lipoprotein Cholesterol (LDL-C)|Change from Baseline in 5D-itch scale|Change from Baseline in Visual Analog Score (VAS)|Change from Baseline in PBC-40 Quality of Life (QoL)|Cmax of EDP-305|Tmax of EDP-305|AUC of EDP-305|Change from baseline of FGF19|Change from baseline of C4|Change from baseline of Total Bile Acids","Up to 12 weeks|Measurement at Week 12|Up to Week 12",null,"nadda@enanta.com","Nathalie Adda","617 607 0705","Little Rock, Arkansas, United States, 72205Principal Investigator: Alonzo Williams Texas Clinical Research InstituteLittle Rock, Arkansas, United States, 76012Principal Investigator: Reem Ghalib|Coronado, California, United States, 92118Principal Investigator: Tarek Hassanein Cedars-Sinai Medical CenterLos Angeles, California, United States, 90048Principal Investigator: Ayoub Walid California Liver Research InstituePasadena, California, United States, 91105Principal Investigator: Edward Mena Inland Empire Liver FoundationRialto, California, United States, 92377|Inverness, Florida, United States, 34452Principal Investigator: Paul Hellstern University Of Miami Leonard M. Miller School Of MedicineMiami, Florida, United States, 33136Principal Investigator: Cynthia Levy|Atlanta, Georgia, United States, 30312Principal Investigator: Gary Richter|Baltimore, Maryland, United States, 21202|Detroit, Michigan, United States, 48377Principal Investigator: Reena Salgia|Omaha, Nebraska, United States, 68124Principal Investigator: Sandeep Mukherjee|Manhasset, New York, United States, 11030Principal Investigator: David Bernstein Mount Sinai Beth IsrealNew York, New York, United States, 10016Principal Investigator: Ira Jacobson Weill Cornell Medical CollegeNew York, New York, United States, 10024Principal Investigator: Sonal Kumar|Pittsburgh, Pennsylvania, United States, 15213Principal Investigator: Mordechai Rabinovitz|Dallas, Texas, United States, 75203Principal Investigator: Maisha Barnes Liver Consultants Of TexasDallas, Texas, United States, 76104Principal Investigator: Manjushree Gautam Baylor Saint Luke'S Medical CenterHouston, Texas, United States, 77030Principal Investigator: John Vierling American Research Corporation At The Texas Liver InstituteSan Antonio, Texas, United States, 78215|Richmond, Virginia, United States, 23602Principal Investigator: Mitchell Shiffman|Seattle, Washington, United States, 98104Principal Investigator: Kris Kowdley","Arkansas|California|Florida|Georgia|Maryland|Michigan|Nebraska|New York|Pennsylvania|Texas|Virginia|Washington","United States","Arkansas Diagnostic Center|Southern California Research Center|Nature Coast Clinical Research|Consultative Gastroenterology|Mercy Medical Center-Mcauley Plaza|Henry Ford Hospital|Chi Health|Northwell Health|University Of Pittsburgh Medical Center - Center For Liver Disease|The Liver Institute At Methodist Dallas Medical Center|Liver Institute Of Virginia-Bremo|Swedish First Hill Campus",{"$nulls":4},"2018-11-08","2020-05-25T16:35:59.289","2020-05-26T17:10:42.972","NCT03394924"]
["5ecbf3effeab101b15530831","NCT03394924","2019-02-12","Enanta Pharmaceuticals","ENTA","Recruiting","A Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Primary Biliary Cholangitis","Edp-305","FXR Agonist","Yes","['Edp-305']","No",null,"Phase 2",3,119,"Anticipated","2017-12-27","2019-03-01",null,null,"Pharmaceutical Research Associates|Pharmaceutical Research Associates\nTriangle Biostatistics","Other",null,"A randomized, double-blind study to assess the safety, tolerability, PK and efficacy of EDP-305 in subjects with primary biliary cholangitis",null,"A Phase 2 Dose Ranging, Randomized, Double Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Primary Biliary Cholangitis (PBC) With or Without an Inadequate Response to Ursodeoxycholic Acid (UDCA)","EDP 305-201","Primary Biliary Cholangitis","Cholangitis","Biliary Tract Diseases","Gastrointestinal","Experimental|Placebo Comparator","EDP-305 Dose 1|EDP-305 Dose 2|Placebo","Subjects will take 2 tablets once a day orally for 12 weeks|Subjects will take two tablets once a day orally for 12 weeks","Drug","EDP-305 Dose 1|EDP-305 Dose 2|Placebo","Two tablets daily for 12 weeks",null,"EDP-305 Dose 1|EDP-305 Dose 2|Placebo","\n\n * An informed consent document signed and dated by the subject.\n * Male and female subjects of any ethnic origin between the ages of 18 and 75 years, inclusive\n * Male or female with a diagnosis of PBC by at least two of the following criteria: * History of ALP above ULN for at least six months\n    * Positive Anti-Mitochondrial Antibodies (AMA) titers (>1/40 on immunofluorescence or M2 positive by enzyme linked immunosorbent assay (ELISA) or positive PBC-specific antinuclear antibodies)\n   \n   \n * For subjects with no documented liver biopsy performed within 2 years, subjects must undergo a transient elastography (Fibroscan) showing liver stiffness < 14.0 kPA\n * Must be on a stable dose of UDCA12-20 mg/kg/day for at least 6 months prior to Screening or intolerant of UDCA in the opinion of the Investigator (no UDCA for at least 12 weeks prior to Screening)\n * Alkaline Phosphatase (ALP) â‰¥ 1.67 Ã— ULN and/or total bilirubin >ULN but < 2Ã—ULN (<2.4 mg/dL)\n * Subjects must have Screening laboratory values for Hepatitis B surface antigen (HBsAg), anti-HCV antibodies and HCV RNA negative and Human Immunodeficiency Virus (HIV) 1 and 2 antibodies (Ab) as seronegative. Note: subjects previously infected by chronic hepatitis C and treated with direct acting antivirals (DAAs) with sustained virologic response (SVR) for at least 3 years will be allowed.\n * Female subjects of childbearing potential must agree to use two effective methods of contraception from the date of Screening until 90 days after the last dose of EDP-305.\n * All male participants who have not had a vasectomy must use effective contraception from Day -1 to 90 days after their last dose of study drug.\n * Male subjects must agree to refrain from sperm donation from the date of Screening until 90 days after their last dose of study drug\n * Screening body mass index (BMI) of â‰¥18 kg/m2\n * Subject must be willing and able to adhere to the assessments, visit schedule, prohibitions and restrictions, as described in this protocol\n\n","\n\n * Laboratory Screening Results: * AST >5 x ULN\n    * ALT >5 x ULN\n    * Patients with Gilbert's syndrome will not be allowed due to interpretability of bilirubin levels\n    * Total white blood cells (WBC) <3000 cells/mm3\n    * Absolute neutrophil count (ANC) <1500 cells/mm3\n    * Platelet count <140,000/mm3\n    * Prothrombin time (international normalized ratio, INR) >1.2\n    * Serum creatinine >2 mg/dL or creatinine clearance <60 mL/min (based on Cockroft-Gault Method)\n   \n   \n * Suspected to have relevant nonalcoholic fatty liver disease (NAFLD) as based on the judgment of the Investigator at Screening\n * Use of immunosuppressants known to have an effect on the liver of patients with PBC (eg, colchicine, methotrexate, azathioprine, or systemic steroids) in the three months preceding screening\n * Current use of fibrates, including fenofibrates. Note: Subjects who discontinued fibrates for at least 3 months before Screening can participate\n * Use of an experimental treatment for PBC within the past 6 months\n * Co-existing liver or biliary diseases, such as primary sclerosing cholangitis, choledocholithiasis, acute or chronic hepatitis, autoimmune hepatitis, alcoholic liver disease, nonalcoholic steatohepatitis (NASH), acute infection of bile duct system or gall bladder, history of gastrointestinal bleeding (secondary to portal hypertension), cirrhosis, cholangiocarcinoma diagnosed or suspected liver cancers\n * Cirrhosis with or without complications, including history or presence of: spontaneous bacterial peritonitis, hepatocellular carcinoma\n * Hepatorenal syndrome (type I or II) or Screening serum creatinine > 2 mg/dL (178 Î¼mol/L)\n * Prior variceal hemorrhage, uncontrolled encephalopathy, Child-Pugh Class A, B and C, esophageal varices, or refractory ascites within the previous 6 months of Screening (defined as date informed consent signed)\n * Medical conditions that may cause nonhepatic increases in ALP (e.g., Paget's disease)\n * Use of a new statin regimen from Screening and throughout study duration. NOTE: Subjects on a stable dose of statins for at least 3 months prior to Screening are allowed. No dose modification during the study will be allowed.\n * Use of immunosuppressants (eg, systemic corticosteroids) for more than 2 consecutive weeks in duration within 1 year prior to Screening.",{"$nulls":4},"Actual","2018-01-09","Actual","Anticipated","2019-04-01","Anticipated","2019-02-01","2017-12-23","2018-01-03","2019-02-10","Yes","PBC\nPrimary Ciliary Cholangitis (PBC)","Interventional","Treatment","Parallel Assignment","Triple (Participant, Care Provider, Investigator)","Randomized","18 Years","75 Years","All",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":19},"Proportion of subjects with at least 20% reduction in ALP from pre-treatment value or normalization of ALP at Week 12","Measurement at Week 12",null,"Safety as measured by â€¢ Frequency of adverse events (AEs), serious AEs, and AEs leading to discontinuation through Week 12|Change from baseline in Bilirubin|Change from Baseline in Alanine aminotransferase (ALT)|Change from Baseline in Aspartate aminotransferase (AST)|Change from Baseline in Gamma-Glutamyl transferase (GGT)|Change from Baseline of Enhanced Liver Fibrosis [ELF] panel|Change from Baseline of PRO C3|Change from Baseline of AST to Platelet Ratio Index [APRI]|Change from Baseline of fibrosis-4 [FIB-4])|Change from Baseline in Triglycerides (TG)|Change from Baseline in Total Cholesterol (TC)|Change from Baseline in High Density Lipoprotein Cholesterol (HDL-C)|Change from Baseline in Low Density Lipoprotein Cholesterol (LDL-C)|Change from Baseline in 5D-itch scale|Change from Baseline in Visual Analog Score (VAS)|Change from Baseline in PBC-40 Quality of Life (QoL)|Cmax of EDP-305|Tmax of EDP-305|AUC of EDP-305|Change from baseline of FGF19|Change from baseline of C4|Change from baseline of Total Bile Acids","Up to 12 weeks|Measurement at Week 12|Up to Week 12",null,"nadda@enanta.com","Nathalie Adda","617 607 0705","Perth, Western|Kingswood, New South Wales, Australia, 2747|Clayton, Victoria, Australia, 3168|Klagenfurt Am WÃ¶rthersee, Carinthia, Austria, 9020|Wels, Upper|Innsbruck, Tyrol, Austria, 6020|Toronto, Ontario, Canada, M6H 3M1|Strasbourg Cedex, Alsace, France, 67091|Pessac, Aquitaine, France, 33600|Villejuif Cedex, Ile-De-|Montpellier Cedex 5, Languedoc-Roussillon, France, 34295|Lille, Nord Pas-De-Calais, France, 59037|Amiens Cedex 1, Picardie, France, 80054|Lyon Cedex 04, Rhone-Alpes, France, 69317|Berlin, Germany, 13353|Frankfurt Am Main, Hessen, Germany, 60590|Bonn, Nordrhein-Westfalen, Germany, 53127|Mainz, Rheinland-Pfalz, Germany, 55131|Leipzig, Sachsen, Germany, 04103|Boston, Massachusetts, United States, 02215|Leiden, Zuid-Holland, Netherlands, 2333 Za|San Sebastian, Guipuzcoa, Spain, 20014|Barcelona, Spain, 08029|El Palmar, Murcia, Spain, 30120|Birmingham, England, United Kingdom, B15 2Tt|Edinburgh, Scotland, United Kingdom, Eh16 4Sa|Dothan, Alabama, United States, 36305|Little Rock, Arkansas, United States, 72205Principal Investigator: Alonzo Williams Texas Clinical Research InstituteLittle Rock, Arkansas, United States, 76012Principal Investigator: Reem Ghalib|Coronado, California, United States, 92118Principal Investigator: Tarek Hassanein Cedars-Sinai Medical CenterLos Angeles, California, United States, 90048Principal Investigator: Ayoub Walid California Liver Research InstituePasadena, California, United States, 91105Principal Investigator: Edward Mena Pasadena Liver CenterPasadena, California, United States, 91105|Clearwater, Florida, United States, 33756-3839|Atlanta, Georgia, United States, 30312Principal Investigator: Gary Richter|Chicago, Illinois, United States, 60611|Iowa City, Iowa, United States, 52242|Shreveport, Louisiana, United States, 71105|Baltimore, Maryland, United States, 21202|Boston, Massachusetts, United States, 02114|Detroit, Michigan, United States, 48377Principal Investigator: Reena Salgia|Omaha, Nebraska, United States, 68124Principal Investigator: Sandeep Mukherjee|Bronx, New York, United States, 10461-1925|Pittsburgh, Pennsylvania, United States, 15213Principal Investigator: Mordechai Rabinovitz|Dallas, Texas, United States, 75203Principal Investigator: Maisha Barnes Liver Consultants Of TexasDallas, Texas, United States, 76104Principal Investigator: Manjushree Gautam Baylor Saint Luke'S Medical CenterHouston, Texas, United States, 77030Principal Investigator: John Vierling American Research Corporation At The Texas Liver InstituteSan Antonio, Texas, United States, 78215|Richmond, Virginia, United States, 23602Principal Investigator: Mitchell Shiffman|Seattle, Washington, United States, 98104Principal Investigator: Kris Kowdley University Of WashingtonSeattle, Washington, United States, 98195-6460","Alabama|Arkansas|California|Florida|Georgia|Illinois|Iowa|Louisiana|Maryland|Massachusetts|Michigan|Nebraska|New York|Pennsylvania|Texas|Virginia|Washington","Australia|Austria|Canada|France|Germany|Israel|Netherlands|Spain|United Kingdom|United States","Linear Clinical Research|New South Wales Nepean Hospital|Victoria Monash Medical Centre|Carinthia Klinikum Klagenfurt Am WÃ¶rthersee|Klinikum Wels-Grieskirchen|Tyrol Medizinische UniversitÃ¤t Innsbruck|Ontario Toronto Liver Center|Alsace Nouvel HÃ´pital Civil|Aquitaine HÃ´pital Haut-LÃ©vÃªque|HÃ´pital Paul Brousse|Languedoc-Roussillon HÃ´pital Saint-Eloi|Nord Pas-De-Calais Centre Hospitalier RÃ©gional Universitaire De Lille|Picardie Centre Hospitalier Universitaire Amines-Picardie HÃ´pital Sud|Rhone-Alpes HÃ´pital De La Croix Rousse|CharitÃ© UniversitÃ¤tsmedizin Berlin|Hessen UniversitÃ¤tsklinikum Frankfurt|Nordrhein-Westfalen UniversitÃ¤tsklinikum Bonn|Rheinland-Pfalz Universitaetsmedizin Der Johannes Gutenberg-Universitaet Mainz|Sachsen UniversitÃ¤tsklinikum Leipzig|Deaconess Medical Center|Zuid-Holland Leiden Universitair Medisch Centrum|Guipuzcoa Hospital Universitario Donostia|Hospital Universitari Vall D'HebrÃ³n|Murcia Hospital Universitario Virgen De La Arrixaca|, England University Hospitals Birmingham Nhs Foundation Trust|, Scotland Nhs Lothian|Digestive Health Specialists Of The Southeast|Arkansas Diagnostic Center|Southern California Research Center|Gastroenterology Consultants Of Clearwater|Consultative Gastroenterology|Northwestern University|University Of Iowa Hospitals And Clinics|Louisiana Research Center|Mercy Medical Center-Mcauley Plaza|Massachusetts General Hospital|Henry Ford Hospital|Chi Health|Montefiore Medical Center - Bronx|University Of Pittsburgh Medical Center - Center For Liver Disease|The Liver Institute At Methodist Dallas Medical Center|Liver Institute Of Virginia-Bremo|Swedish First Hill Campus",{"$nulls":4},"2019-02-10","2020-05-25T16:35:59.413","2020-05-26T17:10:42.972","NCT03394924"]
["5ecbf3ef307e3d1b1f8d9c92","NCT03394924","2019-03-20","Enanta Pharmaceuticals","ENTA","Recruiting","A Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Primary Biliary Cholangitis","Edp-305","FXR Agonist","Yes","['Edp-305']","No",null,"Phase 2",3,119,"Anticipated","2017-12-27","2019-03-01",null,null,"Pharmaceutical Research Associates|Pharmaceutical Research Associates\nTriangle Biostatistics","Other",null,"A randomized, double-blind study to assess the safety, tolerability, PK and efficacy of EDP-305 in subjects with primary biliary cholangitis",null,"A Phase 2 Dose Ranging, Randomized, Double Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Primary Biliary Cholangitis (PBC) With or Without an Inadequate Response to Ursodeoxycholic Acid (UDCA)","EDP 305-201","Primary Biliary Cholangitis","Cholangitis","Biliary Tract Diseases","Gastrointestinal","Experimental|Placebo Comparator","EDP-305 Dose 1|EDP-305 Dose 2|Placebo","Subjects will take 2 tablets once a day orally for 12 weeks|Subjects will take two tablets once a day orally for 12 weeks","Drug","EDP-305 Dose 1|EDP-305 Dose 2|Placebo","Two tablets daily for 12 weeks",null,"EDP-305 Dose 1|EDP-305 Dose 2|Placebo","\n\n * An informed consent document signed and dated by the subject.\n * Male and female subjects of any ethnic origin between the ages of 18 and 75 years, inclusive\n * Male or female with a diagnosis of PBC by at least two of the following criteria: * History of ALP above ULN for at least six months\n    * Positive Anti-Mitochondrial Antibodies (AMA) titers (>1/40 on immunofluorescence or M2 positive by enzyme linked immunosorbent assay (ELISA) or positive PBC-specific antinuclear antibodies)\n   \n   \n * For subjects with no documented liver biopsy performed within 2 years, subjects must undergo a transient elastography (Fibroscan) showing liver stiffness < 14.0 kPA\n * Must be on a stable dose of UDCA12-20 mg/kg/day for at least 6 months prior to Screening or intolerant of UDCA in the opinion of the Investigator (no UDCA for at least 12 weeks prior to Screening)\n * Alkaline Phosphatase (ALP) â‰¥ 1.67 Ã— ULN and/or total bilirubin >ULN but < 2Ã—ULN (<2.4 mg/dL)\n * Subjects must have Screening laboratory values for Hepatitis B surface antigen (HBsAg), anti-HCV antibodies and HCV RNA negative and Human Immunodeficiency Virus (HIV) 1 and 2 antibodies (Ab) as seronegative. Note: subjects previously infected by chronic hepatitis C and treated with direct acting antivirals (DAAs) with sustained virologic response (SVR) for at least 3 years will be allowed.\n * Female subjects of childbearing potential must agree to use two effective methods of contraception from the date of Screening until 90 days after the last dose of EDP-305.\n * All male participants who have not had a vasectomy must use effective contraception from Day -1 to 90 days after their last dose of study drug.\n * Male subjects must agree to refrain from sperm donation from the date of Screening until 90 days after their last dose of study drug\n * Screening body mass index (BMI) of â‰¥18 kg/m2\n * Subject must be willing and able to adhere to the assessments, visit schedule, prohibitions and restrictions, as described in this protocol\n\n","\n\n * Laboratory Screening Results: * AST >5 x ULN\n    * ALT >5 x ULN\n    * Patients with Gilbert's syndrome will not be allowed due to interpretability of bilirubin levels\n    * Total white blood cells (WBC) <3000 cells/mm3\n    * Absolute neutrophil count (ANC) <1500 cells/mm3\n    * Platelet count <140,000/mm3\n    * Prothrombin time (international normalized ratio, INR) >1.2\n    * Serum creatinine >2 mg/dL or creatinine clearance <60 mL/min (based on Cockroft-Gault Method)\n   \n   \n * Suspected to have relevant nonalcoholic fatty liver disease (NAFLD) as based on the judgment of the Investigator at Screening\n * Use of immunosuppressants known to have an effect on the liver of patients with PBC (eg, colchicine, methotrexate, azathioprine, or systemic steroids) in the three months preceding screening\n * Current use of fibrates, including fenofibrates. Note: Subjects who discontinued fibrates for at least 3 months before Screening can participate\n * Use of an experimental treatment for PBC within the past 6 months\n * Co-existing liver or biliary diseases, such as primary sclerosing cholangitis, choledocholithiasis, acute or chronic hepatitis, autoimmune hepatitis, alcoholic liver disease, nonalcoholic steatohepatitis (NASH), acute infection of bile duct system or gall bladder, history of gastrointestinal bleeding (secondary to portal hypertension), cirrhosis, cholangiocarcinoma diagnosed or suspected liver cancers\n * Cirrhosis with or without complications, including history or presence of: spontaneous bacterial peritonitis, hepatocellular carcinoma\n * Hepatorenal syndrome (type I or II) or Screening serum creatinine > 2 mg/dL (178 Î¼mol/L)\n * Prior variceal hemorrhage, uncontrolled encephalopathy, Child-Pugh Class A, B and C, esophageal varices, or refractory ascites within the previous 6 months of Screening (defined as date informed consent signed)\n * Medical conditions that may cause nonhepatic increases in ALP (e.g., Paget's disease)\n * Use of a new statin regimen from Screening and throughout study duration. NOTE: Subjects on a stable dose of statins for at least 3 months prior to Screening are allowed. No dose modification during the study will be allowed.\n * Use of immunosuppressants (eg, systemic corticosteroids) for more than 2 consecutive weeks in duration within 1 year prior to Screening.",{"$nulls":4},"Actual","2018-01-09","Actual","Anticipated","2019-04-01","Anticipated","2019-03-01","2017-12-23","2018-01-03","2019-03-18","Yes","PBC\nPrimary Ciliary Cholangitis (PBC)","Interventional","Treatment","Parallel Assignment","Triple (Participant, Care Provider, Investigator)","Randomized","18 Years","75 Years","All",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":19},"Proportion of subjects with at least 20% reduction in ALP from pre-treatment value or normalization of ALP at Week 12","Measurement at Week 12",null,"Safety as measured by â€¢ Frequency of adverse events (AEs), serious AEs, and AEs leading to discontinuation through Week 12|Change from baseline in Bilirubin|Change from Baseline in Alanine aminotransferase (ALT)|Change from Baseline in Aspartate aminotransferase (AST)|Change from Baseline in Gamma-Glutamyl transferase (GGT)|Change from Baseline of Enhanced Liver Fibrosis [ELF] panel|Change from Baseline of PRO C3|Change from Baseline of AST to Platelet Ratio Index [APRI]|Change from Baseline of fibrosis-4 [FIB-4])|Change from Baseline in Triglycerides (TG)|Change from Baseline in Total Cholesterol (TC)|Change from Baseline in High Density Lipoprotein Cholesterol (HDL-C)|Change from Baseline in Low Density Lipoprotein Cholesterol (LDL-C)|Change from Baseline in 5D-itch scale|Change from Baseline in Visual Analog Score (VAS)|Change from Baseline in PBC-40 Quality of Life (QoL)|Cmax of EDP-305|Tmax of EDP-305|AUC of EDP-305|Change from baseline of FGF19|Change from baseline of C4|Change from baseline of Total Bile Acids","Up to 12 weeks|Measurement at Week 12|Up to Week 12",null,"nadda@enanta.com","Nathalie Adda","617 607 0705","Perth, Western|Kingswood, New South Wales, Australia, 2747|Clayton, Victoria, Australia, 3168|Klagenfurt Am WÃ¶rthersee, Carinthia, Austria, 9020|Wels, Upper|Innsbruck, Tyrol, Austria, 6020|Genk, Limburg, Belgium, 3600|Gent, Oost-Vlaanderen, Belgium, 9000|London, Ontario, Canada, N6A 5A5|Strasbourg Cedex, Alsace, France, 67091|Pessac, Aquitaine, France, 33600|Paris Cedex 12, Ile-De-|Montpellier Cedex 5, Languedoc-Roussillon, France, 34295|Lille, Nord Pas-De-Calais, France, 59037|Amiens Cedex 1, Picardie, France, 80054|Lyon Cedex 04, Rhone-Alpes, France, 69317|Berlin, Germany, 13353|Frankfurt Am Main, Hessen, Germany, 60590|Bonn, Nordrhein-Westfalen, Germany, 53127|Mainz, Rheinland-Pfalz, Germany, 55131|Leipzig, Sachsen, Germany, 04103|Boston, Massachusetts, United States, 02215|Amsterdam, Noord-Holland, Netherlands, 1081 Hv|Utrecht, Netherlands, 3584 Cx|Leiden, Zuid-Holland, Netherlands, 2333 Za|San Sebastian, Guipuzcoa, Spain, 20014|Barcelona, Spain, 08029|El Palmar, Murcia, Spain, 30120|Birmingham, England, United Kingdom, B15 2Tt|Edinburgh, Scotland, United Kingdom, Eh16 4Sa|Dothan, Alabama, United States, 36305|Little Rock, Arkansas, United States, 72205Principal Investigator: Alonzo Williams Texas Clinical Research InstituteLittle Rock, Arkansas, United States, 76012Principal Investigator: Reem Ghalib|Coronado, California, United States, 92118Principal Investigator: Tarek Hassanein Cedars-Sinai Medical CenterLos Angeles, California, United States, 90048Principal Investigator: Ayoub Walid California Liver Research InstituePasadena, California, United States, 91105Principal Investigator: Edward Mena Pasadena Liver CenterPasadena, California, United States, 91105|Clearwater, Florida, United States, 33756-3839|Atlanta, Georgia, United States, 30312Principal Investigator: Gary Richter|Chicago, Illinois, United States, 60611|Iowa City, Iowa, United States, 52242|Shreveport, Louisiana, United States, 71105|Baltimore, Maryland, United States, 21202|Boston, Massachusetts, United States, 02114|Detroit, Michigan, United States, 48377Principal Investigator: Reena Salgia|Omaha, Nebraska, United States, 68124Principal Investigator: Sandeep Mukherjee|Bronx, New York, United States, 10461-1925|Pittsburgh, Pennsylvania, United States, 15213Principal Investigator: Mordechai Rabinovitz|Dallas, Texas, United States, 75203Principal Investigator: Maisha Barnes Liver Consultants Of TexasDallas, Texas, United States, 76104Principal Investigator: Manjushree Gautam Baylor Saint Luke'S Medical CenterHouston, Texas, United States, 77030Principal Investigator: John Vierling American Research Corporation At The Texas Liver InstituteSan Antonio, Texas, United States, 78215|Richmond, Virginia, United States, 23602Principal Investigator: Mitchell Shiffman|Seattle, Washington, United States, 98104Principal Investigator: Kris Kowdley University Of WashingtonSeattle, Washington, United States, 98195-6460","Alabama|Arkansas|California|Florida|Georgia|Illinois|Iowa|Louisiana|Maryland|Massachusetts|Michigan|Nebraska|New York|Pennsylvania|Texas|Virginia|Washington","Australia|Austria|Belgium|Canada|France|Germany|Israel|Netherlands|Spain|United Kingdom|United States","Linear Clinical Research|New South Wales Nepean Hospital|Victoria Monash Medical Centre|Carinthia Klinikum Klagenfurt Am WÃ¶rthersee|Klinikum Wels-Grieskirchen|Tyrol Medizinische UniversitÃ¤t Innsbruck|Limburg Ziekenhuis Oost-Limburg|Oost-Vlaanderen Universitair Ziekenhuis Gent|Ontario London Health Sciences Centre University Hospital|Alsace Nouvel HÃ´pital Civil|Aquitaine HÃ´pital Haut-LÃ©vÃªque|HÃ´pital Saint-Antoine|Languedoc-Roussillon HÃ´pital Saint-Eloi|Nord Pas-De-Calais Centre Hospitalier RÃ©gional Universitaire De Lille|Picardie Centre Hospitalier Universitaire Amines-Picardie HÃ´pital Sud|Rhone-Alpes HÃ´pital De La Croix Rousse|CharitÃ© UniversitÃ¤tsmedizin Berlin|Hessen UniversitÃ¤tsklinikum Frankfurt|Nordrhein-Westfalen UniversitÃ¤tsklinikum Bonn|Rheinland-Pfalz Universitaetsmedizin Der Johannes Gutenberg-Universitaet Mainz|Sachsen UniversitÃ¤tsklinikum Leipzig|Deaconess Medical Center|Noord-Holland Vrije Universiteit Medisch Centrum|Universitair Medisch Centrum Utrecht|Zuid-Holland Leiden Universitair Medisch Centrum|Guipuzcoa Hospital Universitario Donostia|Hospital Universitari Vall D'HebrÃ³n|Murcia Hospital Universitario Virgen De La Arrixaca|, England University Hospitals Birmingham Nhs Foundation Trust|, Scotland Nhs Lothian|Digestive Health Specialists Of The Southeast|Arkansas Diagnostic Center|Southern California Research Center|Gastroenterology Consultants Of Clearwater|Consultative Gastroenterology|Northwestern University|University Of Iowa Hospitals And Clinics|Louisiana Research Center|Mercy Medical Center-Mcauley Plaza|Massachusetts General Hospital|Henry Ford Hospital|Chi Health|Montefiore Medical Center - Bronx|University Of Pittsburgh Medical Center - Center For Liver Disease|The Liver Institute At Methodist Dallas Medical Center|Liver Institute Of Virginia-Bremo|Swedish First Hill Campus",{"$nulls":4},"2019-03-18","2020-05-25T16:35:59.415","2020-05-26T17:10:42.972","NCT03394924"]
["5ecbf3effeab101b15530832","NCT03394924","2019-07-23","Enanta Pharmaceuticals","ENTA","Recruiting","A Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Primary Biliary Cholangitis","Edp-305","FXR Agonist","Yes","['Edp-305']","No",null,"Phase 2",3,119,"Anticipated","2017-12-27","2020-09-01",null,null,"Pharmaceutical Research Associates|Pharmaceutical Research Associates\nTriangle Biostatistics","Other",null,"A randomized, double-blind study to assess the safety, tolerability, PK and efficacy of EDP-305 in subjects with primary biliary cholangitis",null,"A Phase 2 Dose Ranging, Randomized, Double Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Primary Biliary Cholangitis (PBC) With or Without an Inadequate Response to Ursodeoxycholic Acid (UDCA)","EDP 305-201","Primary Biliary Cholangitis","Cholangitis","Biliary Tract Diseases","Gastrointestinal","Experimental|Placebo Comparator","EDP-305 Dose 1|EDP-305 Dose 2|Placebo","Subjects will take 2 tablets once a day orally for 12 weeks|Subjects will take two tablets once a day orally for 12 weeks","Drug","EDP-305 Dose 1|EDP-305 Dose 2|Placebo","Two tablets daily for 12 weeks",null,"EDP-305 Dose 1|EDP-305 Dose 2|Placebo","\n\n * An informed consent document signed and dated by the subject.\n * Male and female subjects of any ethnic origin between the ages of 18 and 75 years, inclusive\n * Male or female with a diagnosis of PBC by at least two of the following criteria: * History of ALP above ULN for at least six months\n    * Positive Anti-Mitochondrial Antibodies (AMA) titers (>1/40 on immunofluorescence or M2 positive by enzyme linked immunosorbent assay (ELISA) or positive PBC-specific antinuclear antibodies)\n   \n   \n * For subjects with no documented liver biopsy performed within 2 years, subjects must undergo a transient elastography (Fibroscan) showing liver stiffness < 14.0 kPA\n * Must be on a stable dose of UDCA12-20 mg/kg/day for at least 6 months prior to Screening or intolerant of UDCA in the opinion of the Investigator (no UDCA for at least 12 weeks prior to Screening)\n * Alkaline Phosphatase (ALP) â‰¥ 1.67 Ã— ULN and/or total bilirubin >ULN but < 2Ã—ULN (<2.4 mg/dL)\n * Subjects must have Screening laboratory values for Hepatitis B surface antigen (HBsAg), anti-HCV antibodies and HCV RNA negative and Human Immunodeficiency Virus (HIV) 1 and 2 antibodies (Ab) as seronegative. Note: subjects previously infected by chronic hepatitis C and treated with direct acting antivirals (DAAs) with sustained virologic response (SVR) for at least 3 years will be allowed.\n * Female subjects of childbearing potential must agree to use two effective methods of contraception from the date of Screening until 90 days after the last dose of EDP-305.\n * All male participants who have not had a vasectomy must use effective contraception from Day -1 to 90 days after their last dose of study drug.\n * Male subjects must agree to refrain from sperm donation from the date of Screening until 90 days after their last dose of study drug\n * Screening body mass index (BMI) of â‰¥18 kg/m2\n * Subject must be willing and able to adhere to the assessments, visit schedule, prohibitions and restrictions, as described in this protocol\n\n","\n\n * Laboratory Screening Results: * AST >5 x ULN\n    * ALT >5 x ULN\n    * Patients with Gilbert's syndrome will not be allowed due to interpretability of bilirubin levels\n    * Total white blood cells (WBC) <3000 cells/mm3\n    * Absolute neutrophil count (ANC) <1500 cells/mm3\n    * Platelet count <140,000/mm3\n    * Prothrombin time (international normalized ratio, INR) >1.2\n    * Serum creatinine >2 mg/dL or creatinine clearance <60 mL/min (based on Cockroft-Gault Method)\n   \n   \n * Suspected to have relevant nonalcoholic fatty liver disease (NAFLD) as based on the judgment of the Investigator at Screening\n * Use of immunosuppressants known to have an effect on the liver of patients with PBC (eg, colchicine, methotrexate, azathioprine, or systemic steroids) in the three months preceding screening\n * Current use of fibrates, including fenofibrates. Note: Subjects who discontinued fibrates for at least 3 months before Screening can participate\n * Use of an experimental treatment for PBC within the past 6 months\n * Co-existing liver or biliary diseases, such as primary sclerosing cholangitis, choledocholithiasis, acute or chronic hepatitis, autoimmune hepatitis, alcoholic liver disease, nonalcoholic steatohepatitis (NASH), acute infection of bile duct system or gall bladder, history of gastrointestinal bleeding (secondary to portal hypertension), cirrhosis, cholangiocarcinoma diagnosed or suspected liver cancers\n * Cirrhosis with or without complications, including history or presence of: spontaneous bacterial peritonitis, hepatocellular carcinoma\n * Hepatorenal syndrome (type I or II) or Screening serum creatinine > 2 mg/dL (178 Î¼mol/L)\n * Prior variceal hemorrhage, uncontrolled encephalopathy, Child-Pugh Class A, B and C, esophageal varices, or refractory ascites within the previous 6 months of Screening (defined as date informed consent signed)\n * Medical conditions that may cause nonhepatic increases in ALP (e.g., Paget's disease)\n * Use of a new statin regimen from Screening and throughout study duration. NOTE: Subjects on a stable dose of statins for at least 3 months prior to Screening are allowed. No dose modification during the study will be allowed.\n * Use of immunosuppressants (eg, systemic corticosteroids) for more than 2 consecutive weeks in duration within 1 year prior to Screening.",{"$nulls":4},"Actual","2018-01-09","Actual","Anticipated","2020-10-01","Anticipated","2019-07-01","2017-12-23","2018-01-03","2019-07-19","Yes","PBC\nPrimary Ciliary Cholangitis (PBC)","Interventional","Treatment","Parallel Assignment","Triple (Participant, Care Provider, Investigator)","Randomized","18 Years","75 Years","All",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":19},"Proportion of subjects with at least 20% reduction in ALP from pre-treatment value or normalization of ALP at Week 12","Measurement at Week 12",null,"Safety as measured by â€¢ Frequency of adverse events (AEs), serious AEs, and AEs leading to discontinuation through Week 12|Change from baseline in Bilirubin|Change from Baseline in Alanine aminotransferase (ALT)|Change from Baseline in Aspartate aminotransferase (AST)|Change from Baseline in Gamma-Glutamyl transferase (GGT)|Change from Baseline of Enhanced Liver Fibrosis [ELF] panel|Change from Baseline of PRO C3|Change from Baseline of AST to Platelet Ratio Index [APRI]|Change from Baseline of fibrosis-4 [FIB-4])|Change from Baseline in Triglycerides (TG)|Change from Baseline in Total Cholesterol (TC)|Change from Baseline in High Density Lipoprotein Cholesterol (HDL-C)|Change from Baseline in Low Density Lipoprotein Cholesterol (LDL-C)|Change from Baseline in 5D-itch scale|Change from Baseline in Visual Analog Score (VAS)|Change from Baseline in PBC-40 Quality of Life (QoL)|Cmax of EDP-305|Tmax of EDP-305|AUC of EDP-305|Change from baseline of FGF19|Change from baseline of C4|Change from baseline of Total Bile Acids","Up to 12 weeks|Measurement at Week 12|Up to Week 12",null,"nadda@enanta.com","Nathalie Adda","617 607 0705","Perth, Western|Kingswood, New South Wales, Australia, 2747|Clayton, Victoria, Australia, 3168|Klagenfurt Am WÃ¶rthersee, Carinthia, Austria, 9020|Wels, Upper|Innsbruck, Tyrol, Austria, 6020|LiÃ¨ge, Liege, Belgium, 4000|Genk, Limburg, Belgium, 3600|Gent, Oost-Vlaanderen, Belgium, 9000|London, Ontario, Canada, N6A 5A5|Strasbourg Cedex, Alsace, France, 67091|Pessac, Aquitaine, France, 33600|Paris Cedex 12, Ile-De-|Montpellier Cedex 5, Languedoc-Roussillon, France, 34295|Lille, Nord Pas-De-Calais, France, 59037|Amiens Cedex 1, Picardie, France, 80054|Lyon Cedex 04, Rhone-Alpes, France, 69317|WÃ¼rzburg, Bayern, Germany, 97080|Berlin, Germany, 13353|Frankfurt Am Main, Hessen, Germany, 60590|Bonn, Nordrhein-Westfalen, Germany, 53127|Mainz, Rheinland-Pfalz, Germany, 55131|Leipzig, Sachsen, Germany, 04103|Boston, Massachusetts, United States, 02215|Amsterdam, Noord-Holland, Netherlands, 1081 Hv|Utrecht, Netherlands, 3584 Cx|Leiden, Zuid-Holland, Netherlands, 2333 Za|San Sebastian, Guipuzcoa, Spain, 20014|Barcelona, Spain, 08029|El Palmar, Murcia, Spain, 30120|Birmingham, England, United Kingdom, B15 2Tt|Edinburgh, Scotland, United Kingdom, Eh16 4Sa|Dothan, Alabama, United States, 36305|Little Rock, Arkansas, United States, 72205Principal Investigator: Alonzo Williams Texas Clinical Research InstituteLittle Rock, Arkansas, United States, 76012Principal Investigator: Reem Ghalib|Coronado, California, United States, 92118Principal Investigator: Tarek Hassanein Cedars-Sinai Medical CenterLos Angeles, California, United States, 90048Principal Investigator: Ayoub Walid California Liver Research InstituePasadena, California, United States, 91105Principal Investigator: Edward Mena Pasadena Liver CenterPasadena, California, United States, 91105|Englewood, Colorado, United States, 80113|New Haven, Connecticut, United States, 06520|Clearwater, Florida, United States, 33756-3839|Atlanta, Georgia, United States, 30312Principal Investigator: Gary Richter|Chicago, Illinois, United States, 60611|Iowa City, Iowa, United States, 52242|Shreveport, Louisiana, United States, 71105|Baltimore, Maryland, United States, 21202|Boston, Massachusetts, United States, 02114|Detroit, Michigan, United States, 48377Principal Investigator: Reena Salgia|Omaha, Nebraska, United States, 68124Principal Investigator: Sandeep Mukherjee|Bronx, New York, United States, 10461-1925|Pittsburgh, Pennsylvania, United States, 15213Principal Investigator: Mordechai Rabinovitz|Dallas, Texas, United States, 75203Principal Investigator: Maisha Barnes Liver Consultants Of TexasDallas, Texas, United States, 76104Principal Investigator: Manjushree Gautam Baylor Saint Luke'S Medical CenterHouston, Texas, United States, 77030Principal Investigator: John Vierling American Research Corporation At The Texas Liver InstituteSan Antonio, Texas, United States, 78215|Richmond, Virginia, United States, 23602Principal Investigator: Mitchell Shiffman|Seattle, Washington, United States, 98104Principal Investigator: Kris Kowdley University Of WashingtonSeattle, Washington, United States, 98195-6460","Alabama|Arkansas|California|Colorado|Connecticut|Florida|Georgia|Illinois|Iowa|Louisiana|Maryland|Massachusetts|Michigan|Nebraska|New York|Pennsylvania|Texas|Virginia|Washington","Australia|Austria|Belgium|Canada|France|Germany|Israel|Netherlands|Spain|United Kingdom|United States","Linear Clinical Research|New South Wales Nepean Hospital|Victoria Monash Medical Centre|Carinthia Klinikum Klagenfurt Am WÃ¶rthersee|Klinikum Wels-Grieskirchen|Tyrol Medizinische UniversitÃ¤t Innsbruck|Liege Chu De LiÃ¨ge, Cardiology Dept.|Limburg Ziekenhuis Oost-Limburg|Oost-Vlaanderen Universitair Ziekenhuis Gent|Ontario London Health Sciences Centre University Hospital|Alsace Nouvel HÃ´pital Civil|Aquitaine HÃ´pital Haut-LÃ©vÃªque|HÃ´pital Saint-Antoine|Languedoc-Roussillon HÃ´pital Saint-Eloi|Nord Pas-De-Calais Centre Hospitalier RÃ©gional Universitaire De Lille|Picardie Centre Hospitalier Universitaire Amines-Picardie HÃ´pital Sud|Rhone-Alpes HÃ´pital De La Croix Rousse|Bayern UniversitÃ¤tsklinikum WÃ¼rzburg|CharitÃ© UniversitÃ¤tsmedizin Berlin|Hessen UniversitÃ¤tsklinikum Frankfurt|Nordrhein-Westfalen UniversitÃ¤tsklinikum Bonn|Rheinland-Pfalz Universitaetsmedizin Der Johannes Gutenberg-Universitaet Mainz|Sachsen UniversitÃ¤tsklinikum Leipzig|Deaconess Medical Center|Noord-Holland Vrije Universiteit Medisch Centrum|Universitair Medisch Centrum Utrecht|Zuid-Holland Leiden Universitair Medisch Centrum|Guipuzcoa Hospital Universitario Donostia|Hospital Universitari Vall D'HebrÃ³n|Murcia Hospital Universitario Virgen De La Arrixaca|, England University Hospitals Birmingham Nhs Foundation Trust|, Scotland Nhs Lothian|Digestive Health Specialists Of The Southeast|Arkansas Diagnostic Center|Southern California Research Center|South Denver Gastroenterology - Swedish Medical Center Office|Yale School Of Medicine|Gastroenterology Consultants Of Clearwater|Consultative Gastroenterology|Northwestern University|University Of Iowa Hospitals And Clinics|Louisiana Research Center|Mercy Medical Center-Mcauley Plaza|Massachusetts General Hospital|Henry Ford Hospital|Chi Health|Montefiore Medical Center - Bronx|University Of Pittsburgh Medical Center - Center For Liver Disease|The Liver Institute At Methodist Dallas Medical Center|Liver Institute Of Virginia-Bremo|Swedish First Hill Campus",{"$nulls":4},"2019-07-19","2020-05-25T16:35:59.723","2020-05-26T17:10:42.972","NCT03394924"]
["5ecbf3f0e2561b1b11905cff","NCT03394924","2019-11-15","Enanta Pharmaceuticals","ENTA","Active, not recruiting","A Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Primary Biliary Cholangitis","Edp-305","FXR Agonist","Yes","['Edp-305']","No",null,"Phase 2",3,119,"Anticipated","2017-12-27","2019-12-01",null,null,"Pharmaceutical Research Associates|Pharmaceutical Research Associates\nTriangle Biostatistics","Other",null,"A randomized, double-blind study to assess the safety, tolerability, PK and efficacy of EDP-305 in subjects with primary biliary cholangitis",null,"A Phase 2 Dose Ranging, Randomized, Double Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Primary Biliary Cholangitis (PBC) With or Without an Inadequate Response to Ursodeoxycholic Acid (UDCA)","EDP 305-201","Primary Biliary Cholangitis","Cholangitis","Biliary Tract Diseases","Gastrointestinal","Experimental|Placebo Comparator","EDP-305 Dose 1|EDP-305 Dose 2|Placebo","Subjects will take 2 tablets once a day orally for 12 weeks|Subjects will take two tablets once a day orally for 12 weeks","Drug","EDP-305 Dose 1|EDP-305 Dose 2|Placebo","Two tablets daily for 12 weeks",null,"EDP-305 Dose 1|EDP-305 Dose 2|Placebo","\n\n * An informed consent document signed and dated by the subject.\n * Male and female subjects of any ethnic origin between the ages of 18 and 75 years, inclusive\n * Male or female with a diagnosis of PBC by at least two of the following criteria: * History of ALP above ULN for at least six months\n    * Positive Anti-Mitochondrial Antibodies (AMA) titers (>1/40 on immunofluorescence or M2 positive by enzyme linked immunosorbent assay (ELISA) or positive PBC-specific antinuclear antibodies)\n   \n   \n * For subjects with no documented liver biopsy performed within 2 years, subjects must undergo a transient elastography (Fibroscan) showing liver stiffness < 14.0 kPA\n * Must be on a stable dose of UDCA12-20 mg/kg/day for at least 6 months prior to Screening or intolerant of UDCA in the opinion of the Investigator (no UDCA for at least 12 weeks prior to Screening)\n * Alkaline Phosphatase (ALP) â‰¥ 1.67 Ã— ULN and/or total bilirubin >ULN but < 2Ã—ULN (<2.4 mg/dL)\n * Subjects must have Screening laboratory values for Hepatitis B surface antigen (HBsAg), anti-HCV antibodies and HCV RNA negative and Human Immunodeficiency Virus (HIV) 1 and 2 antibodies (Ab) as seronegative. Note: subjects previously infected by chronic hepatitis C and treated with direct acting antivirals (DAAs) with sustained virologic response (SVR) for at least 3 years will be allowed.\n * Female subjects of childbearing potential must agree to use two effective methods of contraception from the date of Screening until 90 days after the last dose of EDP-305.\n * All male participants who have not had a vasectomy must use effective contraception from Day -1 to 90 days after their last dose of study drug.\n * Male subjects must agree to refrain from sperm donation from the date of Screening until 90 days after their last dose of study drug\n * Screening body mass index (BMI) of â‰¥18 kg/m2\n * Subject must be willing and able to adhere to the assessments, visit schedule, prohibitions and restrictions, as described in this protocol\n\n","\n\n * Laboratory Screening Results: * AST >5 x ULN\n    * ALT >5 x ULN\n    * Patients with Gilbert's syndrome will not be allowed due to interpretability of bilirubin levels\n    * Total white blood cells (WBC) <3000 cells/mm3\n    * Absolute neutrophil count (ANC) <1500 cells/mm3\n    * Platelet count <140,000/mm3\n    * Prothrombin time (international normalized ratio, INR) >1.2\n    * Serum creatinine >2 mg/dL or creatinine clearance <60 mL/min (based on Cockroft-Gault Method)\n   \n   \n * Suspected to have relevant nonalcoholic fatty liver disease (NAFLD) as based on the judgment of the Investigator at Screening\n * Use of immunosuppressants known to have an effect on the liver of patients with PBC (eg, colchicine, methotrexate, azathioprine, or systemic steroids) in the three months preceding screening\n * Current use of fibrates, including fenofibrates. Note: Subjects who discontinued fibrates for at least 3 months before Screening can participate\n * Use of an experimental treatment for PBC within the past 6 months\n * Co-existing liver or biliary diseases, such as primary sclerosing cholangitis, choledocholithiasis, acute or chronic hepatitis, autoimmune hepatitis, alcoholic liver disease, nonalcoholic steatohepatitis (NASH), acute infection of bile duct system or gall bladder, history of gastrointestinal bleeding (secondary to portal hypertension), cirrhosis, cholangiocarcinoma diagnosed or suspected liver cancers\n * Cirrhosis with or without complications, including history or presence of: spontaneous bacterial peritonitis, hepatocellular carcinoma\n * Hepatorenal syndrome (type I or II) or Screening serum creatinine > 2 mg/dL (178 Î¼mol/L)\n * Prior variceal hemorrhage, uncontrolled encephalopathy, Child-Pugh Class A, B and C, esophageal varices, or refractory ascites within the previous 6 months of Screening (defined as date informed consent signed)\n * Medical conditions that may cause nonhepatic increases in ALP (e.g., Paget's disease)\n * Use of a new statin regimen from Screening and throughout study duration. NOTE: Subjects on a stable dose of statins for at least 3 months prior to Screening are allowed. No dose modification during the study will be allowed.\n * Use of immunosuppressants (eg, systemic corticosteroids) for more than 2 consecutive weeks in duration within 1 year prior to Screening.",{"$nulls":4},"Actual","2018-01-09","Actual","Anticipated","2020-01-01","Anticipated","2019-11-01","2017-12-23","2018-01-03","2019-11-13","Yes","PBC\nPrimary Biliary Cholangitis (PBC)","Interventional","Treatment","Parallel Assignment","Triple (Participant, Care Provider, Investigator)","Randomized","18 Years","75 Years","All",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":19},"Proportion of subjects with at least 20% reduction in ALP from pre-treatment value or normalization of ALP at Week 12","Measurement at Week 12",null,"Safety as measured by â€¢ Frequency of adverse events (AEs), serious AEs, and AEs leading to discontinuation through Week 12|Change from baseline in Bilirubin|Change from Baseline in Alanine aminotransferase (ALT)|Change from Baseline in Aspartate aminotransferase (AST)|Change from Baseline in Gamma-Glutamyl transferase (GGT)|Change from Baseline of Enhanced Liver Fibrosis [ELF] panel|Change from Baseline of PRO C3|Change from Baseline of AST to Platelet Ratio Index [APRI]|Change from Baseline of fibrosis-4 [FIB-4])|Change from Baseline in Triglycerides (TG)|Change from Baseline in Total Cholesterol (TC)|Change from Baseline in High Density Lipoprotein Cholesterol (HDL-C)|Change from Baseline in Low Density Lipoprotein Cholesterol (LDL-C)|Change from Baseline in 5D-itch scale|Change from Baseline in Visual Analog Score (VAS)|Change from Baseline in PBC-40 Quality of Life (QoL)|Cmax of EDP-305|Tmax of EDP-305|AUC of EDP-305|Change from baseline of FGF19|Change from baseline of C4|Change from baseline of Total Bile Acids","Up to 12 weeks|Measurement at Week 12|Up to Week 12",{"$nulls":4},"Perth, Western|Kingswood, New South Wales, Australia, 2747|Clayton, Victoria, Australia, 3168|Klagenfurt Am WÃ¶rthersee, Carinthia, Austria, 9020|Wels, Upper|Innsbruck, Tyrol, Austria, 6020|LiÃ¨ge, Liege, Belgium, 4000|Genk, Limburg, Belgium, 3600|Gent, Oost-Vlaanderen, Belgium, 9000|London, Ontario, Canada, N6A 5A5 Toronto General HospitalToronto, Ontario, Canada, M5G 2C4 Toronto Liver CenterToronto, Ontario, Canada, M6H 3M1|Strasbourg Cedex, Alsace, France, 67091|Pessac, Aquitaine, France, 33600|Villejuif Cedex, Ile-De-|Paris Cedex 12, Ile-De-|Montpellier Cedex 5, Languedoc-Roussillon, France, 34295|Lille, Nord Pas-De-Calais, France, 59037|Amiens Cedex 1, Picardie, France, 80054|Lyon Cedex 04, Rhone-Alpes, France, 69317|WÃ¼rzburg, Bayern, Germany, 97080|Berlin, Germany, 13353|Frankfurt Am Main, Hessen, Germany, 60590|Bonn, Nordrhein-Westfalen, Germany, 53127 Universitaetsklinikum EssenEssen, Nordrhein-Westfalen, Germany, 45122|Mainz, Rheinland-Pfalz, Germany, 55131|Leipzig, Sachsen, Germany, 04103|Boston, Massachusetts, United States, 02215|Amsterdam, Noord-Holland, Netherlands, 1081 Hv|Utrecht, Netherlands, 3584 Cx|Leiden, Zuid-Holland, Netherlands, 2333 Za|San Sebastian, Guipuzcoa, Spain, 20014|Barcelona, Spain, 08029 Hospital Universitario RamÃ³n Y CajalMadrid, Spain, 28034 Hospital Universitario MarquÃ©s De ValdecillaSantander, Spain, 39008 Hospital Universitario Virgen Del RocioSevilla, Spain, 41013 Hospital Universitari I Politecnic La Fe De ValenciaValencia, Spain, 46026 Universidad De Valladolid - Hospital Universitario Rio HortegaValladolid, Spain, 47010|El Palmar, Murcia, Spain, 30120|Birmingham, England, United Kingdom, B15 2Tt Cambridge University Hospitals Nhs Foundation TrustCambridge, England, United Kingdom, Cb2 0Qq The Leeds Teaching Hospitals Nhs TrustLeeds, England, United Kingdom, Ls9 7Tf King'S College Hospital Nhs Foundation TrustLondon, England, United Kingdom, Se5 9Rs Norfolk And Norwich University Hospitals Nhs Foundation TrustNorwich, England, United Kingdom, Nr4 7Uy Queen'S Medical Centre - NottinghamNottingham, England, United Kingdom, Ng7 2Uh Portsmouth Hospitals Nhs TrustPortsmouth, England, United Kingdom, Po6 3Ly|Edinburgh, Scotland, United Kingdom, Eh16 4Sa|Dothan, Alabama, United States, 36305|Little Rock, Arkansas, United States, 72205 Texas Clinical Research InstituteLittle Rock, Arkansas, United States, 76012|Coronado, California, United States, 92118 Cedars-Sinai Medical CenterLos Angeles, California, United States, 90048 California Liver Research InstituePasadena, California, United States, 91105 Pasadena Liver CenterPasadena, California, United States, 91105 Inland Empire Liver FoundationRialto, California, United States, 92377 California Pacific Medical CenterSan Francisco, California, United States, 94115|Englewood, Colorado, United States, 80113|New Haven, Connecticut, United States, 06520|Clearwater, Florida, United States, 33756-3839 Nature Coast Clinical ResearchInverness, Florida, United States, 34452 University Of Miami Leonard M. Miller School Of MedicineMiami, Florida, United States, 33136|Atlanta, Georgia, United States, 30312|Chicago, Illinois, United States, 60611|Iowa City, Iowa, United States, 52242|Shreveport, Louisiana, United States, 71105|Baltimore, Maryland, United States, 21202 Johns Hopkins UniversityBaltimore, Maryland, United States, 21287 Digestive Disease AssociatesCatonsville, Maryland, United States, 21228|Boston, Massachusetts, United States, 02114 Beth|Detroit, Michigan, United States, 48377|Omaha, Nebraska, United States, 68124|Bronx, New York, United States, 10461-1925 Northwell HealthManhasset, New York, United States, 11030 Concorde Medical GroupNew York, New York, United States, 10016 Mount Sinai Beth IsrealNew York, New York, United States, 10016 Weill Cornell Medical CollegeNew York, New York, United States, 10024 Icahn School Of Medicine At Mount SinaiNew York, New York, United States, 10029|Pittsburgh, Pennsylvania, United States, 15213|Dallas, Texas, United States, 75203 Liver Consultants Of TexasDallas, Texas, United States, 76104 Baylor Saint Luke'S Medical CenterHouston, Texas, United States, 77030 American Research Corporation At The Texas Liver InstituteSan Antonio, Texas, United States, 78215|Richmond, Virginia, United States, 23602|Seattle, Washington, United States, 98104 University Of WashingtonSeattle, Washington, United States, 98195-6460","Alabama|Arkansas|California|Colorado|Connecticut|Florida|Georgia|Illinois|Iowa|Louisiana|Maryland|Massachusetts|Michigan|Nebraska|New York|Pennsylvania|Texas|Virginia|Washington","Australia|Austria|Belgium|Canada|France|Germany|Israel|Netherlands|Spain|United Kingdom|United States","Linear Clinical Research|New South Wales Nepean Hospital|Victoria Monash Medical Centre|Carinthia Klinikum Klagenfurt Am WÃ¶rthersee|Klinikum Wels-Grieskirchen|Tyrol Medizinische UniversitÃ¤t Innsbruck|Liege Chu De LiÃ¨ge, Cardiology Dept.|Limburg Ziekenhuis Oost-Limburg|Oost-Vlaanderen Universitair Ziekenhuis Gent|Ontario London Health Sciences Centre University Hospital|Alsace Nouvel HÃ´pital Civil|Aquitaine HÃ´pital Haut-LÃ©vÃªque|France, 75012 HÃ´pital Paul Brousse|HÃ´pital Saint-Antoine|Languedoc-Roussillon HÃ´pital Saint-Eloi|Nord Pas-De-Calais Centre Hospitalier RÃ©gional Universitaire De Lille|Picardie Centre Hospitalier Universitaire Amines-Picardie HÃ´pital Sud|Rhone-Alpes HÃ´pital De La Croix Rousse|Bayern UniversitÃ¤tsklinikum WÃ¼rzburg|CharitÃ© UniversitÃ¤tsmedizin Berlin|Hessen UniversitÃ¤tsklinikum Frankfurt|Nordrhein-Westfalen UniversitÃ¤tsklinikum Bonn|Rheinland-Pfalz Universitaetsmedizin Der Johannes Gutenberg-Universitaet Mainz|Sachsen UniversitÃ¤tsklinikum Leipzig|Deaconess Medical Center|Noord-Holland Vrije Universiteit Medisch Centrum|Universitair Medisch Centrum Utrecht|Zuid-Holland Leiden Universitair Medisch Centrum|Guipuzcoa Hospital Universitario Donostia|Hospital Universitari Vall D'HebrÃ³n|Murcia Hospital Universitario Virgen De La Arrixaca|, England University Hospitals Birmingham Nhs Foundation Trust|, Scotland Nhs Lothian|Digestive Health Specialists Of The Southeast|Arkansas Diagnostic Center|Southern California Research Center|South Denver Gastroenterology - Swedish Medical Center Office|Yale School Of Medicine|Gastroenterology Consultants Of Clearwater|Consultative Gastroenterology|Northwestern University|University Of Iowa Hospitals And Clinics|Louisiana Research Center|Mercy Medical Center-Mcauley Plaza|Massachusetts General Hospital|Henry Ford Hospital|Chi Health|Montefiore Medical Center - Bronx|University Of Pittsburgh Medical Center - Center For Liver Disease|The Liver Institute At Methodist Dallas Medical Center|Liver Institute Of Virginia-Bremo|Swedish First Hill Campus",{"$nulls":4},"2019-11-13","2020-05-25T16:36:00.409","2020-05-26T17:10:42.972","NCT03394924"]
["5ecbf3f111702c1b1b916a18","NCT03395184","2018-01-10","Pfizer","PFE","Not yet recruiting","Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PFâ€‘06700841 In Subjects With Moderate To Severe Crohn's Disease","Brepocitinib|Pf-06651600","JAK1 Inhibitor|TYK2 Inhibitor|JAK1 Inhibitor|JAK3 Inhibitor","Yes","['Brepocitinib', 'Pf-06651600']","Yes","['TYK2 Inhibitor', 'JAK3 Inhibitor']","Phase 2",2,250,"Anticipated","2018-01-23","2020-01-22","DAS","Disease Activity Score",{"$nulls":3},"The objectives of this study are to evaluate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-06651600 (200 mg for 8 weeks followed by 50 mg for 4 weeks) dosed once daily and PF-06700841 (60 mg for 12 weeks) dosed once daily during an induction period of 12 weeks, followed by an open label extension period at doses of 50 mg and 30 mg of PF 06651600 and PF 06700841, respectively, for 52 weeks.",null,"A PHASE 2A, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ORAL PF-06651600 AND PF-06700841 AS INDUCTION AND OPEN LABEL EXTENSION TREATMENT IN SUBJECTS WITH MODERATE TO SEVERE CROHN'S DISEASE","B7981007","Crohn's Disease","Crohn Disease","Gastrointestinal Diseases","Gastrointestinal","Experimental","PF-06700841 or placebo|PF-06651600 or placebo",null,"Drug","Placebo PF-06700841|PF-06700841|Placebo PF-06651600|PF-06651600","12 weeks, followed by PF-06700841, 30 mg QD for 52 weeks.|60 mg QD for 12 weeks followed by 30 mg QD for up to 52 weeks|12 weeks, followed by PF-06651600, 50 mg QD for 52 weeks|200 mg QD for 8 weeks, followed by 50 mg QD up to 56 weeks",null,"PF-06700841 or placebo|PF-06651600 or placebo","\n\n 1. Male and/or female subjects 18 years to 75 years of age\n 2. Documented diagnosis of ileal, ileocolonic, or colonic CD with a minimum disease duration of 3 months, as determined by endoscopic and histopathology assessment.\n 3. Endoscopic confirmation of active disease with total SES CD total score of at least 7. For isolated ileal disease, SES CD total score should be at least 4.\n 4. An average daily liquid/soft stool frequency (SF) greater than or equal to 2.5 or daily abdominal pain (AP) greater than or equal to 2.0.\n 5. Must have inadequate response to, loss of response to, or intolerance to at least one conventional therapy for CD:â€¢Steroids; Immunosuppressants (azathioprine [AZA], 6 MP, or methotrexate [MTX]); Anti TNF inhibitors (infliximab, adalimumab, or golimumab, certolizumab); Anti integrin inhibitors (eg, vedolizumab); Anti IL 12/23 inhibitor (ustekinumab).\n    \n    \n 6. Subjects currently receiving the following treatment for CD are eligible providing they have been on stable doses as described below: * Oral corticosteroids (prednisone or equivalent up to 25 mg/day; budesonide up to 9 mg/day). Stable dose for at least 2 weeks prior to baseline. If oral corticosteroids have been recently discontinued, they must have been stopped at least 2 weeks prior to baseline. Decreases in steroid use due to AEs are allowed.\n     * Oral 5 ASA or sulfasalazine are allowed providing that the dose is stable for at least 4 weeks prior to baseline.\n     * Crohn's disease related antibiotics are allowed providing that the dose is stable for at least 4 weeks prior to baseline. If antibiotics are stopped prior to baseline, they must be discontinued at least 4 days prior to baseline.\n    \n    \n\n","\n\n 1.  Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, diverticular disease, ulcerative colitis (UC), or clinical findings suggestive of UC.\n 2.  Presence of active (draining) fistulae or intra abdominal or perineal abscesses.\n 3.  Strictures with obstructive symptoms.\n 4.  Short bowel syndrome.\n 5.  History of bowel perforation requiring surgical intervention within the past 12 months.\n 6.  Previous bowel surgery resulting in an existing stoma. Subjects who have a j pouch are excluded, as a j pouch can result in a stoma.\n 7.  History of bowel surgery within 6 months prior to baseline.\n 8.  Subjects displaying clinical signs of fulminant colitis or toxic megacolon.\n 9.  Subjects with primary sclerosing cholangitis.\n 10. Subjects with evidence of colonic adenomas, dysplasia or neoplasia.\n 11. Abnormal findings on the chest x ray film such as presence of tuberculosis (TB), general infections, heart failure, or malignancy.\n 12. Any history of either untreated or inadequately treated latent or active TB infection, current treatment for active or latent TB infection or evidence of currently active TB by chest x ray, residing with or frequent close contact with individual(s) with active TB.\n 13. Subjects receiving the following therapies within the time period described below or expected to receive any of these therapies during the study period: 1.  >9 mg/day of oral budesonide or >25 mg/day of prednisone or equivalent oral systemic corticosteroid dose within 2 weeks prior to baseline.\n      2.  IV, IM (parenteral), or topical (rectal) treatment of 5 ASA or corticosteroid enemas/suppositories within 2 weeks prior to baseline.\n      3.  Azathioprine, 6 mercaptopurine, or methotrexate within 2 weeks prior to baseline.\n      4.  Anti TNF inhibitors (or biosimilars thereof) as described below: * Infliximab within 8 weeks prior to baseline;\n           * Adalimumab within 8 weeks prior to baseline;\n           * Golimumab within 8 weeks prior to baseline;\n           * Certolizumab within 8 weeks prior to baseline;\n          \n          \n      5.  Anti integrin inhibitors (eg, vedolizumab) within 8 weeks prior to baseline.\n      6.  Ustekinumab within 8 weeks prior to baseline.\n      7.  Interferon therapy within 8 weeks prior to baseline.\n      8.  Subjects with prior treatment with lymphocyte depleting agents/therapies within 1 year prior to baseline (eg, CamPath[alemtuzumab], alkylating agents [eg, cyclophosphamide or chlorambucil], total lymphoid irradiation, etc).\n      9.  Subjects who have received rituximab or other selective B lymphocyte depleting agents within 1 year prior to baseline.\n      10. Subjects previously receiving leukocyte apheresis, including selective lymphocyte, monocyte, or granulocyte apheresis, or plasma exchange within 6 months prior to baseline.\n      11. Other marketed immunosuppressants or biologics with immunomodulatory properties within 3 months prior to baseline.\n      12. Subjects who have received other JAK inhibitors within 3 months prior to baseline.\n      13. Subjects who have not responded to or have been intolerant of other JAK inhibitors.\n      14. Other investigational procedures(s) or product(s), such as immunosuppressants used in transplantation (eg, mycophenolate mofetil, cyclosporine, rapamycin, or tacrolimus) or live (attenuated) vaccine within 30 days prior to baseline.","TNF","tumor necrosis factor","Protein","Lung, Breast, Ovary","Actual","2018-01-10","Actual","Anticipated","2021-02-05","Anticipated","2018-01-01","2017-12-05","2018-01-03","2018-01-03","Yes",null,"Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years","75 Years","All",null,"No","Yes\nInformation relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests",null,"URL: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7981007&StudyName=A+Phase+2a%2C+Double-blind%2C+Randomized%2C+Placebo-controlled%2C+Parallel+Group+Study+To+Evaluate+The+Efficacy+And+Safety+Of+Oral+Pf-06651600+And+Pf-06700841+As+Induction+And+Open+Label+Extension+Treatment+In+Subjects+With+Moderate+To+Severe+Crohn%E2%80%99s+Disease [https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7981007&StudyName=A+Phase+2a%2C+Double-blind%2C+Randomized%2C+Placebo-controlled%2C+Parallel+Group+Study+To+Evaluate+The+Efficacy+And+Safety+Of+Oral+Pf-06651600+And+Pf-06700841+As+Induction+And+Open+Label+Extension+Treatment+In+Subjects+With+Moderate+To+Severe+Crohn%E2%80%99s+Disease] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To obtain contact information for a study center near you, click here.",null,"Yes","No",{"$nulls":17},"2017-003359-43","EudraCT Number","Proportion of subjects achieving clinically meaningful endoscopic improvement (reduction of more than or equal to 3 points from baseline in Simplified Endoscopic Activity Score for Crohn's Disease (SES-CD) at Week 12","12 weeks",null,"Mean change from baseline in SES-CD score at Week 12.|Proportion of subjects achieving SES-CD 25 and SES-CD 50 at Week 12.|Proportion of subjects achieving endoscopic remission (SES-CD less than or equal to 2) at Week 12.|Proportion of subjects achieving mucosal healing at Week 12.|Number of subjects with adverse events|Number of subjects with serious adverse events|Number of subjects withdrawal due to adverse events|Number of subjects with vital signs findings of potential clinical importance.|Number of subjects with laboratory tests findings of potential clinical importance.|Number of subjects with electrocardiogram findings of potential clinical importance.|Number of participants with potentially clinically important serious infections findings","Baseline, week 12|Number of subjects achieving SES-CD 25 and SES-CD 50 at Week 12.|Number of subjects achieving endoscopic remission (SES-CD less than or equal to 2) at Week 12.|Number of subjects achieving mucosal healing at Week 12.|Number of participants with reported adverse events|Number of participants with reported serious adverse events|Number of subjects withdrawal due to adverse events.|Number of participants with potentially clinically important vital signs findings.|Number of participants with potentially clinically important laboratory findings.|Number of participants with potentially clinically important electrocardiogram findings.|64 weeks","Baseline, week 12|Week 12|Baseline up to 64 weeks|Baseline u to 64 weeks","ClinicalTrials.gov_Inquiries@pfizer.com","Pfizer CT.gov Call Center","1-800-718-1021",{"$nulls":7},"Pfizer CT.gov Call Center","2018-01-03","2020-05-25T16:36:01.777","2020-05-26T17:10:42.972","NCT03395184"]
["5ecbf3f1fe30261b1a048207","NCT03395184","2018-01-25","Pfizer","PFE","Not yet recruiting","Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PFâ€‘06700841 In Subjects With Moderate To Severe Crohn's Disease","Brepocitinib|Pf-06651600","JAK1 Inhibitor|TYK2 Inhibitor|JAK1 Inhibitor|JAK3 Inhibitor","Yes","['Brepocitinib', 'Pf-06651600']","Yes","['TYK2 Inhibitor', 'JAK3 Inhibitor']","Phase 2",2,250,"Anticipated","2018-01-23","2020-01-22","DAS","Disease Activity Score",{"$nulls":3},"The objectives of this study are to evaluate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-06651600 (200 mg for 8 weeks followed by 50 mg for 4 weeks) dosed once daily and PF-06700841 (60 mg for 12 weeks) dosed once daily during an induction period of 12 weeks, followed by an open label extension period at doses of 50 mg and 30 mg of PF 06651600 and PF 06700841, respectively, for 52 weeks.",null,"A PHASE 2A, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ORAL PF-06651600 AND PF-06700841 AS INDUCTION AND OPEN LABEL EXTENSION TREATMENT IN SUBJECTS WITH MODERATE TO SEVERE CROHN'S DISEASE","B7981007","Crohn's Disease","Crohn Disease","Gastrointestinal Diseases","Gastrointestinal","Experimental","PF-06700841 or placebo|PF-06651600 or placebo",null,"Drug","Placebo PF-06700841|PF-06700841|Placebo PF-06651600|PF-06651600","12 weeks, followed by PF-06700841, 30 mg QD for 52 weeks.|60 mg QD for 12 weeks followed by 30 mg QD for up to 52 weeks|12 weeks, followed by PF-06651600, 50 mg QD for 52 weeks|200 mg QD for 8 weeks, followed by 50 mg QD up to 56 weeks",null,"PF-06700841 or placebo|PF-06651600 or placebo","\n\n 1. Male and/or female subjects 18 years to 75 years of age\n 2. Documented diagnosis of ileal, ileocolonic, or colonic CD with a minimum disease duration of 3 months, as determined by endoscopic and histopathology assessment.\n 3. Endoscopic confirmation of active disease with total SES CD total score of at least 7. For isolated ileal disease, SES CD total score should be at least 4.\n 4. An average daily liquid/soft stool frequency (SF) greater than or equal to 2.5 or daily abdominal pain (AP) greater than or equal to 2.0.\n 5. Must have inadequate response to, loss of response to, or intolerance to at least one conventional therapy for CD:â€¢Steroids; Immunosuppressants (azathioprine [AZA], 6 MP, or methotrexate [MTX]); Anti TNF inhibitors (infliximab, adalimumab, or golimumab, certolizumab); Anti integrin inhibitors (eg, vedolizumab); Anti IL 12/23 inhibitor (ustekinumab).\n    \n    \n 6. Subjects currently receiving the following treatment for CD are eligible providing they have been on stable doses as described below: * Oral corticosteroids (prednisone or equivalent up to 25 mg/day; budesonide up to 9 mg/day). Stable dose for at least 2 weeks prior to baseline. If oral corticosteroids have been recently discontinued, they must have been stopped at least 2 weeks prior to baseline. Decreases in steroid use due to AEs are allowed.\n     * Oral 5 ASA or sulfasalazine are allowed providing that the dose is stable for at least 4 weeks prior to baseline.\n     * Crohn's disease related antibiotics are allowed providing that the dose is stable for at least 4 weeks prior to baseline. If antibiotics are stopped prior to baseline, they must be discontinued at least 4 days prior to baseline.\n    \n    \n\n","\n\n 1.  Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, diverticular disease, ulcerative colitis (UC), or clinical findings suggestive of UC.\n 2.  Presence of active (draining) fistulae or intra abdominal or perineal abscesses.\n 3.  Strictures with obstructive symptoms.\n 4.  Short bowel syndrome.\n 5.  History of bowel perforation requiring surgical intervention within the past 12 months.\n 6.  Previous bowel surgery resulting in an existing stoma. Subjects who have a j pouch are excluded, as a j pouch can result in a stoma.\n 7.  History of bowel surgery within 6 months prior to baseline.\n 8.  Subjects displaying clinical signs of fulminant colitis or toxic megacolon.\n 9.  Subjects with primary sclerosing cholangitis.\n 10. Subjects with evidence of colonic adenomas, dysplasia or neoplasia.\n 11. Abnormal findings on the chest x ray film such as presence of tuberculosis (TB), general infections, heart failure, or malignancy.\n 12. Any history of either untreated or inadequately treated latent or active TB infection, current treatment for active or latent TB infection or evidence of currently active TB by chest x ray, residing with or frequent close contact with individual(s) with active TB.\n 13. Subjects receiving the following therapies within the time period described below or expected to receive any of these therapies during the study period: 1.  >9 mg/day of oral budesonide or >25 mg/day of prednisone or equivalent oral systemic corticosteroid dose within 2 weeks prior to baseline.\n      2.  IV, IM (parenteral), or topical (rectal) treatment of 5 ASA or corticosteroid enemas/suppositories within 2 weeks prior to baseline.\n      3.  Azathioprine, 6 mercaptopurine, or methotrexate within 2 weeks prior to baseline.\n      4.  Anti TNF inhibitors (or biosimilars thereof) as described below: * Infliximab within 8 weeks prior to baseline;\n           * Adalimumab within 8 weeks prior to baseline;\n           * Golimumab within 8 weeks prior to baseline;\n           * Certolizumab within 8 weeks prior to baseline;\n          \n          \n      5.  Anti integrin inhibitors (eg, vedolizumab) within 8 weeks prior to baseline.\n      6.  Ustekinumab within 8 weeks prior to baseline.\n      7.  Interferon therapy within 8 weeks prior to baseline.\n      8.  Subjects with prior treatment with lymphocyte depleting agents/therapies within 1 year prior to baseline (eg, CamPath[alemtuzumab], alkylating agents [eg, cyclophosphamide or chlorambucil], total lymphoid irradiation, etc).\n      9.  Subjects who have received rituximab or other selective B lymphocyte depleting agents within 1 year prior to baseline.\n      10. Subjects previously receiving leukocyte apheresis, including selective lymphocyte, monocyte, or granulocyte apheresis, or plasma exchange within 6 months prior to baseline.\n      11. Other marketed immunosuppressants or biologics with immunomodulatory properties within 3 months prior to baseline.\n      12. Subjects who have received other JAK inhibitors within 3 months prior to baseline.\n      13. Subjects who have not responded to or have been intolerant of other JAK inhibitors.\n      14. Other investigational procedures(s) or product(s), such as immunosuppressants used in transplantation (eg, mycophenolate mofetil, cyclosporine, rapamycin, or tacrolimus) or live (attenuated) vaccine within 30 days prior to baseline.","TNF","tumor necrosis factor","Protein","Lung, Breast, Ovary","Actual","2018-01-10","Actual","Anticipated","2021-02-05","Anticipated","2018-01-01","2017-12-05","2018-01-03","2018-01-23","Yes",null,"Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years","75 Years","All",null,"No","Yes\nInformation relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests",null,"URL: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7981007&StudyName=A+Phase+2a%2C+Double-blind%2C+Randomized%2C+Placebo-controlled%2C+Parallel+Group+Study+To+Evaluate+The+Efficacy+And+Safety+Of+Oral+Pf-06651600+And+Pf-06700841+As+Induction+And+Open+Label+Extension+Treatment+In+Subjects+With+Moderate+To+Severe+Crohn%E2%80%99s+Disease [https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7981007&StudyName=A+Phase+2a%2C+Double-blind%2C+Randomized%2C+Placebo-controlled%2C+Parallel+Group+Study+To+Evaluate+The+Efficacy+And+Safety+Of+Oral+Pf-06651600+And+Pf-06700841+As+Induction+And+Open+Label+Extension+Treatment+In+Subjects+With+Moderate+To+Severe+Crohn%E2%80%99s+Disease] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To obtain contact information for a study center near you, click here.",null,"Yes","No",{"$nulls":17},"2017-003359-43","EudraCT Number","Proportion of subjects achieving clinically meaningful endoscopic improvement (reduction of more than or equal to 3 points from baseline in Simplified Endoscopic Activity Score for Crohn's Disease (SES-CD) at Week 12","12 weeks",null,"Number of participants with potentially clinically important serious infections findings|Mean change from baseline in SES-CD score at Week 12.|Proportion of subjects achieving SES-CD 25 and SES-CD 50 at Week 12.|Proportion of subjects achieving endoscopic remission (SES-CD less than or equal to 2) at Week 12.|Proportion of subjects achieving mucosal healing at Week 12.|Number of subjects with adverse events|Number of subjects with serious adverse events|Number of subjects with electrocardiogram findings of potential clinical importance.|Number of subjects withdrawal due to adverse events|Number of subjects with vital signs findings of potential clinical importance.|Number of subjects with laboratory tests findings of potential clinical importance.","64 weeks|Baseline, week 12|Number of subjects achieving SES-CD 25 and SES-CD 50 at Week 12.|Number of subjects achieving endoscopic remission (SES-CD less than or equal to 2) at Week 12.|Number of subjects achieving mucosal healing at Week 12.|Number of participants with reported adverse events|Number of participants with reported serious adverse events|Number of participants with potentially clinically important electrocardiogram findings.|Number of subjects withdrawal due to adverse events.|Number of participants with potentially clinically important vital signs findings.|Number of participants with potentially clinically important laboratory findings.","Baseline, week 12|Week 12|Baseline up to 64 weeks|Baseline u to 64 weeks","ClinicalTrials.gov_Inquiries@pfizer.com","Pfizer CT.gov Call Center","1-800-718-1021",{"$nulls":7},"Pfizer CT.gov Call Center","2018-01-23","2020-05-25T16:36:01.777","2020-05-26T17:10:42.972","NCT03395184"]
["5ecbf3f2e2561b1b11905d03","NCT03395184","2018-02-22","Pfizer","PFE","Recruiting","Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PFâ€‘06700841 In Subjects With Moderate To Severe Crohn's Disease","Brepocitinib|Pf-06651600","JAK1 Inhibitor|TYK2 Inhibitor|JAK1 Inhibitor|JAK3 Inhibitor","Yes","['Brepocitinib', 'Pf-06651600']","Yes","['TYK2 Inhibitor', 'JAK3 Inhibitor']","Phase 2",2,250,"Anticipated","2018-02-05","2020-01-22","DAS","Disease Activity Score",{"$nulls":3},"The objectives of this study are to evaluate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-06651600 (200 mg for 8 weeks followed by 50 mg for 4 weeks) dosed once daily and PF-06700841 (60 mg for 12 weeks) dosed once daily during an induction period of 12 weeks, followed by an open label extension period at doses of 50 mg and 30 mg of PF 06651600 and PF 06700841, respectively, for 52 weeks.",null,"A PHASE 2A, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ORAL PF-06651600 AND PF-06700841 AS INDUCTION AND OPEN LABEL EXTENSION TREATMENT IN SUBJECTS WITH MODERATE TO SEVERE CROHN'S DISEASE","B7981007","Crohn's Disease","Crohn Disease","Gastrointestinal Diseases","Gastrointestinal","Experimental","PF-06700841 or placebo|PF-06651600 or placebo",null,"Drug","Placebo PF-06700841|PF-06700841|Placebo PF-06651600|PF-06651600","12 weeks, followed by PF-06700841, 30 mg QD for 52 weeks.|60 mg QD for 12 weeks followed by 30 mg QD for up to 52 weeks|12 weeks, followed by PF-06651600, 50 mg QD for 52 weeks|200 mg QD for 8 weeks, followed by 50 mg QD up to 56 weeks",null,"PF-06700841 or placebo|PF-06651600 or placebo","\n\n 1. Male and/or female subjects 18 years to 75 years of age\n 2. Documented diagnosis of ileal, ileocolonic, or colonic CD with a minimum disease duration of 3 months, as determined by endoscopic and histopathology assessment.\n 3. Endoscopic confirmation of active disease with total SES CD total score of at least 7. For isolated ileal disease, SES CD total score should be at least 4.\n 4. An average daily liquid/soft stool frequency (SF) greater than or equal to 2.5 or daily abdominal pain (AP) greater than or equal to 2.0.\n 5. Must have inadequate response to, loss of response to, or intolerance to at least one conventional therapy for CD:â€¢Steroids; Immunosuppressants (azathioprine [AZA], 6 MP, or methotrexate [MTX]); Anti TNF inhibitors (infliximab, adalimumab, or golimumab, certolizumab); Anti integrin inhibitors (eg, vedolizumab); Anti IL 12/23 inhibitor (ustekinumab).\n    \n    \n 6. Subjects currently receiving the following treatment for CD are eligible providing they have been on stable doses as described below: * Oral corticosteroids (prednisone or equivalent up to 25 mg/day; budesonide up to 9 mg/day). Stable dose for at least 2 weeks prior to baseline. If oral corticosteroids have been recently discontinued, they must have been stopped at least 2 weeks prior to baseline. Decreases in steroid use due to AEs are allowed.\n     * Oral 5 ASA or sulfasalazine are allowed providing that the dose is stable for at least 4 weeks prior to baseline.\n     * Crohn's disease related antibiotics are allowed providing that the dose is stable for at least 4 weeks prior to baseline. If antibiotics are stopped prior to baseline, they must be discontinued at least 4 days prior to baseline.\n    \n    \n\n","\n\n 1.  Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, diverticular disease, ulcerative colitis (UC), or clinical findings suggestive of UC.\n 2.  Presence of active (draining) fistulae or intra abdominal or perineal abscesses.\n 3.  Strictures with obstructive symptoms.\n 4.  Short bowel syndrome.\n 5.  History of bowel perforation requiring surgical intervention within the past 12 months.\n 6.  Previous bowel surgery resulting in an existing stoma. Subjects who have a j pouch are excluded, as a j pouch can result in a stoma.\n 7.  History of bowel surgery within 6 months prior to baseline.\n 8.  Subjects displaying clinical signs of fulminant colitis or toxic megacolon.\n 9.  Subjects with primary sclerosing cholangitis.\n 10. Subjects with evidence of colonic adenomas, dysplasia or neoplasia.\n 11. Abnormal findings on the chest x ray film such as presence of tuberculosis (TB), general infections, heart failure, or malignancy.\n 12. Any history of either untreated or inadequately treated latent or active TB infection, current treatment for active or latent TB infection or evidence of currently active TB by chest x ray, residing with or frequent close contact with individual(s) with active TB.\n 13. Subjects receiving the following therapies within the time period described below or expected to receive any of these therapies during the study period: 1.  >9 mg/day of oral budesonide or >25 mg/day of prednisone or equivalent oral systemic corticosteroid dose within 2 weeks prior to baseline.\n      2.  IV, IM (parenteral), or topical (rectal) treatment of 5 ASA or corticosteroid enemas/suppositories within 2 weeks prior to baseline.\n      3.  Azathioprine, 6 mercaptopurine, or methotrexate within 2 weeks prior to baseline.\n      4.  Anti TNF inhibitors (or biosimilars thereof) as described below: * Infliximab within 8 weeks prior to baseline;\n           * Adalimumab within 8 weeks prior to baseline;\n           * Golimumab within 8 weeks prior to baseline;\n           * Certolizumab within 8 weeks prior to baseline;\n          \n          \n      5.  Anti integrin inhibitors (eg, vedolizumab) within 8 weeks prior to baseline.\n      6.  Ustekinumab within 8 weeks prior to baseline.\n      7.  Interferon therapy within 8 weeks prior to baseline.\n      8.  Subjects with prior treatment with lymphocyte depleting agents/therapies within 1 year prior to baseline (eg, CamPath[alemtuzumab], alkylating agents [eg, cyclophosphamide or chlorambucil], total lymphoid irradiation, etc).\n      9.  Subjects who have received rituximab or other selective B lymphocyte depleting agents within 1 year prior to baseline.\n      10. Subjects previously receiving leukocyte apheresis, including selective lymphocyte, monocyte, or granulocyte apheresis, or plasma exchange within 6 months prior to baseline.\n      11. Other marketed immunosuppressants or biologics with immunomodulatory properties within 3 months prior to baseline.\n      12. Subjects who have received other JAK inhibitors within 3 months prior to baseline.\n      13. Subjects who have not responded to or have been intolerant of other JAK inhibitors.\n      14. Other investigational procedures(s) or product(s), such as immunosuppressants used in transplantation (eg, mycophenolate mofetil, cyclosporine, rapamycin, or tacrolimus) or live (attenuated) vaccine within 30 days prior to baseline.","TNF","tumor necrosis factor","Protein","Lung, Breast, Ovary","Actual","2018-01-10","Actual","Anticipated","2021-02-05","Anticipated","2018-02-01","2017-12-05","2018-01-03","2018-02-19","Yes",null,"Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years","75 Years","All",null,"No","Yes\nInformation relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests",null,"URL: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7981007&StudyName=A+Phase+2a%2C+Double-blind%2C+Randomized%2C+Placebo-controlled%2C+Parallel+Group+Study+To+Evaluate+The+Efficacy+And+Safety+Of+Oral+Pf-06651600+And+Pf-06700841+As+Induction+And+Open+Label+Extension+Treatment+In+Subjects+With+Moderate+To+Severe+Crohn%E2%80%99s+Disease [https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7981007&StudyName=A+Phase+2a%2C+Double-blind%2C+Randomized%2C+Placebo-controlled%2C+Parallel+Group+Study+To+Evaluate+The+Efficacy+And+Safety+Of+Oral+Pf-06651600+And+Pf-06700841+As+Induction+And+Open+Label+Extension+Treatment+In+Subjects+With+Moderate+To+Severe+Crohn%E2%80%99s+Disease] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To obtain contact information for a study center near you, click here.",null,"Yes","No",{"$nulls":17},"2017-003359-43","EudraCT Number","Proportion of subjects achieving clinically meaningful endoscopic improvement (reduction of more than or equal to 3 points from baseline in Simplified Endoscopic Activity Score for Crohn's Disease (SES-CD) at Week 12","12 weeks",null,"Number of participants with potentially clinically important serious infections findings|Mean change from baseline in SES-CD score at Week 12.|Proportion of subjects achieving SES-CD 25 and SES-CD 50 at Week 12.|Proportion of subjects achieving endoscopic remission (SES-CD less than or equal to 2) at Week 12.|Proportion of subjects achieving mucosal healing at Week 12.|Number of subjects with adverse events|Number of subjects with serious adverse events|Number of subjects with electrocardiogram findings of potential clinical importance.|Number of subjects withdrawal due to adverse events|Number of subjects with vital signs findings of potential clinical importance.|Number of subjects with laboratory tests findings of potential clinical importance.","64 weeks|Baseline, week 12|Number of subjects achieving SES-CD 25 and SES-CD 50 at Week 12.|Number of subjects achieving endoscopic remission (SES-CD less than or equal to 2) at Week 12.|Number of subjects achieving mucosal healing at Week 12.|Number of participants with reported adverse events|Number of participants with reported serious adverse events|Number of participants with potentially clinically important electrocardiogram findings.|Number of subjects withdrawal due to adverse events.|Number of participants with potentially clinically important vital signs findings.|Number of participants with potentially clinically important laboratory findings.","Baseline, week 12|Week 12|Baseline up to 64 weeks|Baseline u to 64 weeks","ClinicalTrials.gov_Inquiries@pfizer.com","Pfizer CT.gov Call Center","1-800-718-1021","Long Beach, California, United States, 90806|Chevy Chase, Maryland, United States, 20815 Mgg Group Co., Inc., Chevy Chase Clinical ResearchChevy Chase, Maryland, United States, 20815|Houston, Texas, United States, 77098|Fairfax, Virginia, United States, 22031","California|Maryland|Texas|Virginia","United States","Long Beach Clinical Trial Services, Inc.|Chevy Chase Endoscopy Center|Gulf Coast Research Group, Llc|Verity Research, Inc.",{"$nulls":3},"Pfizer CT.gov Call Center","2018-02-19","2020-05-25T16:36:02.250","2020-05-26T17:10:42.972","NCT03395184"]
["5ecbf3f2307e3d1b1f8d9c98","NCT03395184","2018-03-08","Pfizer","PFE","Recruiting","Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PFâ€‘06700841 In Subjects With Moderate To Severe Crohn's Disease","Brepocitinib|Pf-06651600","JAK1 Inhibitor|TYK2 Inhibitor|JAK1 Inhibitor|JAK3 Inhibitor","Yes","['Brepocitinib', 'Pf-06651600']","Yes","['TYK2 Inhibitor', 'JAK3 Inhibitor']","Phase 2",2,250,"Anticipated","2018-02-05","2020-02-04","DAS","Disease Activity Score",{"$nulls":3},"The objectives of this study are to evaluate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-06651600 (200 mg for 8 weeks followed by 50 mg for 4 weeks) dosed once daily and PF-06700841 (60 mg for 12 weeks) dosed once daily during an induction period of 12 weeks, followed by an open label extension period at doses of 50 mg and 30 mg of PF 06651600 and PF 06700841, respectively, for 52 weeks.",null,"A PHASE 2A, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ORAL PF-06651600 AND PF-06700841 AS INDUCTION AND OPEN LABEL EXTENSION TREATMENT IN SUBJECTS WITH MODERATE TO SEVERE CROHN'S DISEASE","B7981007","Crohn's Disease","Crohn Disease","Gastrointestinal Diseases","Gastrointestinal","Experimental","PF-06700841 or placebo|PF-06651600 or placebo",null,"Drug","Placebo PF-06700841|PF-06700841|Placebo PF-06651600|PF-06651600","12 weeks, followed by PF-06700841, 30 mg QD for 52 weeks.|60 mg QD for 12 weeks followed by 30 mg QD for up to 52 weeks|12 weeks, followed by PF-06651600, 50 mg QD for 52 weeks|200 mg QD for 8 weeks, followed by 50 mg QD up to 56 weeks",null,"PF-06700841 or placebo|PF-06651600 or placebo","\n\n 1. Male and/or female subjects 18 years to 75 years of age\n 2. Documented diagnosis of ileal, ileocolonic, or colonic CD with a minimum disease duration of 3 months, as determined by endoscopic and histopathology assessment.\n 3. Endoscopic confirmation of active disease with total SES CD total score of at least 7. For isolated ileal disease, SES CD total score should be at least 4.\n 4. An average daily liquid/soft stool frequency (SF) greater than or equal to 2.5 or daily abdominal pain (AP) greater than or equal to 2.0.\n 5. Must have inadequate response to, loss of response to, or intolerance to at least one conventional therapy for CD:â€¢Steroids; Immunosuppressants (azathioprine [AZA], 6 MP, or methotrexate [MTX]); Anti TNF inhibitors (infliximab, adalimumab, or golimumab, certolizumab); Anti integrin inhibitors (eg, vedolizumab); Anti IL 12/23 inhibitor (ustekinumab).\n    \n    \n 6. Subjects currently receiving the following treatment for CD are eligible providing they have been on stable doses as described below: * Oral corticosteroids (prednisone or equivalent up to 25 mg/day; budesonide up to 9 mg/day). Stable dose for at least 2 weeks prior to baseline. If oral corticosteroids have been recently discontinued, they must have been stopped at least 2 weeks prior to baseline. Decreases in steroid use due to AEs are allowed.\n     * Oral 5 ASA or sulfasalazine are allowed providing that the dose is stable for at least 4 weeks prior to baseline.\n     * Crohn's disease related antibiotics are allowed providing that the dose is stable for at least 4 weeks prior to baseline. If antibiotics are stopped prior to baseline, they must be discontinued at least 4 days prior to baseline.\n    \n    \n\n","\n\n 1.  Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, diverticular disease, ulcerative colitis (UC), or clinical findings suggestive of UC.\n 2.  Presence of active (draining) fistulae or intra abdominal or perineal abscesses.\n 3.  Strictures with obstructive symptoms.\n 4.  Short bowel syndrome.\n 5.  History of bowel perforation requiring surgical intervention within the past 12 months.\n 6.  Previous bowel surgery resulting in an existing stoma. Subjects who have a j pouch are excluded, as a j pouch can result in a stoma.\n 7.  History of bowel surgery within 6 months prior to baseline.\n 8.  Subjects displaying clinical signs of fulminant colitis or toxic megacolon.\n 9.  Subjects with primary sclerosing cholangitis.\n 10. Subjects with evidence of colonic adenomas, dysplasia or neoplasia.\n 11. Abnormal findings on the chest x ray film such as presence of tuberculosis (TB), general infections, heart failure, or malignancy.\n 12. Any history of either untreated or inadequately treated latent or active TB infection, current treatment for active or latent TB infection or evidence of currently active TB by chest x ray, residing with or frequent close contact with individual(s) with active TB.\n 13. Subjects receiving the following therapies within the time period described below or expected to receive any of these therapies during the study period: 1.  >9 mg/day of oral budesonide or >25 mg/day of prednisone or equivalent oral systemic corticosteroid dose within 2 weeks prior to baseline.\n      2.  IV, IM (parenteral), or topical (rectal) treatment of 5 ASA or corticosteroid enemas/suppositories within 2 weeks prior to baseline.\n      3.  Azathioprine, 6 mercaptopurine, or methotrexate within 2 weeks prior to baseline.\n      4.  Anti TNF inhibitors (or biosimilars thereof) as described below: * Infliximab within 8 weeks prior to baseline;\n           * Adalimumab within 8 weeks prior to baseline;\n           * Golimumab within 8 weeks prior to baseline;\n           * Certolizumab within 8 weeks prior to baseline;\n          \n          \n      5.  Anti integrin inhibitors (eg, vedolizumab) within 8 weeks prior to baseline.\n      6.  Ustekinumab within 8 weeks prior to baseline.\n      7.  Interferon therapy within 8 weeks prior to baseline.\n      8.  Subjects with prior treatment with lymphocyte depleting agents/therapies within 1 year prior to baseline (eg, CamPath[alemtuzumab], alkylating agents [eg, cyclophosphamide or chlorambucil], total lymphoid irradiation, etc).\n      9.  Subjects who have received rituximab or other selective B lymphocyte depleting agents within 1 year prior to baseline.\n      10. Subjects previously receiving leukocyte apheresis, including selective lymphocyte, monocyte, or granulocyte apheresis, or plasma exchange within 6 months prior to baseline.\n      11. Other marketed immunosuppressants or biologics with immunomodulatory properties within 3 months prior to baseline.\n      12. Subjects who have received other JAK inhibitors within 3 months prior to baseline.\n      13. Subjects who have not responded to or have been intolerant of other JAK inhibitors.\n      14. Other investigational procedures(s) or product(s), such as immunosuppressants used in transplantation (eg, mycophenolate mofetil, cyclosporine, rapamycin, or tacrolimus) or live (attenuated) vaccine within 30 days prior to baseline.","TNF","tumor necrosis factor","Protein","Lung, Breast, Ovary","Actual","2018-01-10","Actual","Anticipated","2021-02-18","Anticipated","2018-03-01","2017-12-05","2018-01-03","2018-03-07","Yes",null,"Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years","75 Years","All",null,"No","Yes\nInformation relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests",null,"URL: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7981007&StudyName=A+Phase+2a%2C+Double-blind%2C+Randomized%2C+Placebo-controlled%2C+Parallel+Group+Study+To+Evaluate+The+Efficacy+And+Safety+Of+Oral+Pf-06651600+And+Pf-06700841+As+Induction+And+Open+Label+Extension+Treatment+In+Subjects+With+Moderate+To+Severe+Crohn%E2%80%99s+Disease [https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7981007&StudyName=A+Phase+2a%2C+Double-blind%2C+Randomized%2C+Placebo-controlled%2C+Parallel+Group+Study+To+Evaluate+The+Efficacy+And+Safety+Of+Oral+Pf-06651600+And+Pf-06700841+As+Induction+And+Open+Label+Extension+Treatment+In+Subjects+With+Moderate+To+Severe+Crohn%E2%80%99s+Disease] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To obtain contact information for a study center near you, click here.",null,"Yes","No",{"$nulls":17},"2017-003359-43","EudraCT Number","Proportion of subjects achieving clinically meaningful endoscopic improvement (reduction of more than or equal to 3 points from baseline in Simplified Endoscopic Activity Score for Crohn's Disease (SES-CD) at Week 12","12 weeks",null,"Number of participants with potentially clinically important serious infections findings|Mean change from baseline in SES-CD score at Week 12.|Proportion of subjects achieving SES-CD 25 and SES-CD 50 at Week 12.|Proportion of subjects achieving endoscopic remission (SES-CD less than or equal to 2) at Week 12.|Proportion of subjects achieving mucosal healing at Week 12.|Number of subjects with adverse events|Number of subjects with serious adverse events|Number of subjects with electrocardiogram findings of potential clinical importance.|Number of subjects withdrawal due to adverse events|Number of subjects with vital signs findings of potential clinical importance.|Number of subjects with laboratory tests findings of potential clinical importance.","64 weeks|Baseline, week 12|Number of subjects achieving SES-CD 25 and SES-CD 50 at Week 12.|Number of subjects achieving endoscopic remission (SES-CD less than or equal to 2) at Week 12.|Number of subjects achieving mucosal healing at Week 12.|Number of participants with reported adverse events|Number of participants with reported serious adverse events|Number of participants with potentially clinically important electrocardiogram findings.|Number of subjects withdrawal due to adverse events.|Number of participants with potentially clinically important vital signs findings.|Number of participants with potentially clinically important laboratory findings.","Baseline, week 12|Week 12|Baseline up to 64 weeks|Baseline u to 64 weeks","ClinicalTrials.gov_Inquiries@pfizer.com","Pfizer CT.gov Call Center","1-800-718-1021","Beverly Hills, California, United States, 90210 Long Beach Clinical Trial Services, Inc.Long Beach, California, United States, 90806 Entertainment Medical GroupLos Angeles, California, United States, 90036 Gastrointestinal Biosciences Clinical Trials, LlcLos Angeles, California, United States, 90067|Chevy Chase, Maryland, United States, 20815 Mgg Group Co., Inc., Chevy Chase Clinical ResearchChevy Chase, Maryland, United States, 20815|Chesterfield, Michigan, United States, 48047 Eastside Endoscopy CenterMacomb, Michigan, United States, 48044|North Massapequa, New York, United States, 11758-1802|Kingsport, Tennessee, United States, 37660 Holston Medical GroupKingsport, Tennessee, United States, 37660 Holston Valley Surgery Center (Testing Only)Kingsport, Tennessee, United States, 37660|Houston, Texas, United States, 77098 Lonestar Endoscopy, Llp (Endoscopy Location)Southlake, Texas, United States, 76092 Texas Digestive Disease Consultants (Admin, Regulatory)Southlake, Texas, United States, 76092 Texas Digestive Disease ConsultantsSouthlake, Texas, United States, 76092|Fairfax, Virginia, United States, 22031","California|Maryland|Michigan|New York|Tennessee|Texas|Virginia","United States","Brighton Surgical Center|Chevy Chase Endoscopy Center|Clinical Research Institute Of Michigan, Llc|Digiovanna Institute For Medical Education & Research|Holston Medical Group (Drug Shipment Only)|Gulf Coast Research Group, Llc|Verity Research, Inc.",{"$nulls":3},"Pfizer CT.gov Call Center","2018-03-07","2020-05-25T16:36:02.135","2020-05-26T17:10:42.972","NCT03395184"]
["5ecbf3f211702c1b1b916a19","NCT03395184","2018-04-03","Pfizer","PFE","Recruiting","Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PFâ€‘06700841 In Subjects With Moderate To Severe Crohn's Disease","Brepocitinib|Pf-06651600","JAK1 Inhibitor|TYK2 Inhibitor|JAK1 Inhibitor|JAK3 Inhibitor","Yes","['Brepocitinib', 'Pf-06651600']","Yes","['TYK2 Inhibitor', 'JAK3 Inhibitor']","Phase 2",2,250,"Anticipated","2018-02-05","2020-02-04","DAS","Disease Activity Score",{"$nulls":3},"The objectives of this study are to evaluate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-06651600 (200 mg for 8 weeks followed by 50 mg for 4 weeks) dosed once daily and PF-06700841 (60 mg for 12 weeks) dosed once daily during an induction period of 12 weeks, followed by an open label extension period at doses of 50 mg and 30 mg of PF 06651600 and PF 06700841, respectively, for 52 weeks.",null,"A PHASE 2A, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ORAL PF-06651600 AND PF-06700841 AS INDUCTION AND OPEN LABEL EXTENSION TREATMENT IN SUBJECTS WITH MODERATE TO SEVERE CROHN'S DISEASE","B7981007","Crohn's Disease","Crohn Disease","Gastrointestinal Diseases","Gastrointestinal","Experimental","PF-06700841 or placebo|PF-06651600 or placebo",null,"Drug","Placebo PF-06700841|PF-06700841|Placebo PF-06651600|PF-06651600","12 weeks, followed by PF-06700841, 30 mg QD for 52 weeks.|60 mg QD for 12 weeks followed by 30 mg QD for up to 52 weeks|12 weeks, followed by PF-06651600, 50 mg QD for 52 weeks|200 mg QD for 8 weeks, followed by 50 mg QD up to 56 weeks",null,"PF-06700841 or placebo|PF-06651600 or placebo","\n\n 1. Male and/or female subjects 18 years to 75 years of age\n 2. Documented diagnosis of ileal, ileocolonic, or colonic CD with a minimum disease duration of 3 months, as determined by endoscopic and histopathology assessment.\n 3. Endoscopic confirmation of active disease with total SES CD total score of at least 7. For isolated ileal disease, SES CD total score should be at least 4.\n 4. An average daily liquid/soft stool frequency (SF) greater than or equal to 2.5 or daily abdominal pain (AP) greater than or equal to 2.0.\n 5. Must have inadequate response to, loss of response to, or intolerance to at least one conventional therapy for CD:â€¢Steroids; Immunosuppressants (azathioprine [AZA], 6 MP, or methotrexate [MTX]); Anti TNF inhibitors (infliximab, adalimumab, or golimumab, certolizumab); Anti integrin inhibitors (eg, vedolizumab); Anti IL 12/23 inhibitor (ustekinumab).\n    \n    \n 6. Subjects currently receiving the following treatment for CD are eligible providing they have been on stable doses as described below: * Oral corticosteroids (prednisone or equivalent up to 25 mg/day; budesonide up to 9 mg/day). Stable dose for at least 2 weeks prior to baseline. If oral corticosteroids have been recently discontinued, they must have been stopped at least 2 weeks prior to baseline. Decreases in steroid use due to AEs are allowed.\n     * Oral 5 ASA or sulfasalazine are allowed providing that the dose is stable for at least 4 weeks prior to baseline.\n     * Crohn's disease related antibiotics are allowed providing that the dose is stable for at least 4 weeks prior to baseline. If antibiotics are stopped prior to baseline, they must be discontinued at least 4 days prior to baseline.\n    \n    \n\n","\n\n 1.  Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, diverticular disease, ulcerative colitis (UC), or clinical findings suggestive of UC.\n 2.  Presence of active (draining) fistulae or intra abdominal or perineal abscesses.\n 3.  Strictures with obstructive symptoms.\n 4.  Short bowel syndrome.\n 5.  History of bowel perforation requiring surgical intervention within the past 12 months.\n 6.  Previous bowel surgery resulting in an existing stoma. Subjects who have a j pouch are excluded, as a j pouch can result in a stoma.\n 7.  History of bowel surgery within 6 months prior to baseline.\n 8.  Subjects displaying clinical signs of fulminant colitis or toxic megacolon.\n 9.  Subjects with primary sclerosing cholangitis.\n 10. Subjects with evidence of colonic adenomas, dysplasia or neoplasia.\n 11. Abnormal findings on the chest x ray film such as presence of tuberculosis (TB), general infections, heart failure, or malignancy.\n 12. Any history of either untreated or inadequately treated latent or active TB infection, current treatment for active or latent TB infection or evidence of currently active TB by chest x ray, residing with or frequent close contact with individual(s) with active TB.\n 13. Subjects receiving the following therapies within the time period described below or expected to receive any of these therapies during the study period: 1.  >9 mg/day of oral budesonide or >25 mg/day of prednisone or equivalent oral systemic corticosteroid dose within 2 weeks prior to baseline.\n      2.  IV, IM (parenteral), or topical (rectal) treatment of 5 ASA or corticosteroid enemas/suppositories within 2 weeks prior to baseline.\n      3.  Azathioprine, 6 mercaptopurine, or methotrexate within 2 weeks prior to baseline.\n      4.  Anti TNF inhibitors (or biosimilars thereof) as described below: * Infliximab within 8 weeks prior to baseline;\n           * Adalimumab within 8 weeks prior to baseline;\n           * Golimumab within 8 weeks prior to baseline;\n           * Certolizumab within 8 weeks prior to baseline;\n          \n          \n      5.  Anti integrin inhibitors (eg, vedolizumab) within 8 weeks prior to baseline.\n      6.  Ustekinumab within 8 weeks prior to baseline.\n      7.  Interferon therapy within 8 weeks prior to baseline.\n      8.  Subjects with prior treatment with lymphocyte depleting agents/therapies within 1 year prior to baseline (eg, CamPath[alemtuzumab], alkylating agents [eg, cyclophosphamide or chlorambucil], total lymphoid irradiation, etc).\n      9.  Subjects who have received rituximab or other selective B lymphocyte depleting agents within 1 year prior to baseline.\n      10. Subjects previously receiving leukocyte apheresis, including selective lymphocyte, monocyte, or granulocyte apheresis, or plasma exchange within 6 months prior to baseline.\n      11. Other marketed immunosuppressants or biologics with immunomodulatory properties within 3 months prior to baseline.\n      12. Subjects who have received other JAK inhibitors within 3 months prior to baseline.\n      13. Subjects who have not responded to or have been intolerant of other JAK inhibitors.\n      14. Other investigational procedures(s) or product(s), such as immunosuppressants used in transplantation (eg, mycophenolate mofetil, cyclosporine, rapamycin, or tacrolimus) or live (attenuated) vaccine within 30 days prior to baseline.","TNF","tumor necrosis factor","Protein","Lung, Breast, Ovary","Actual","2018-01-10","Actual","Anticipated","2021-02-18","Anticipated","2018-04-01","2017-12-05","2018-01-03","2018-04-02","Yes",null,"Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years","75 Years","All",null,"No","Yes\nInformation relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests",null,"URL: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7981007&StudyName=A+Phase+2a%2C+Double-blind%2C+Randomized%2C+Placebo-controlled%2C+Parallel+Group+Study+To+Evaluate+The+Efficacy+And+Safety+Of+Oral+Pf-06651600+And+Pf-06700841+As+Induction+And+Open+Label+Extension+Treatment+In+Subjects+With+Moderate+To+Severe+Crohn%E2%80%99s+Disease [https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7981007&StudyName=A+Phase+2a%2C+Double-blind%2C+Randomized%2C+Placebo-controlled%2C+Parallel+Group+Study+To+Evaluate+The+Efficacy+And+Safety+Of+Oral+Pf-06651600+And+Pf-06700841+As+Induction+And+Open+Label+Extension+Treatment+In+Subjects+With+Moderate+To+Severe+Crohn%E2%80%99s+Disease] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To obtain contact information for a study center near you, click here.",null,"Yes","No",{"$nulls":17},"2017-003359-43|PIZZICATO","EudraCT Number|Alias Study Number","Proportion of subjects achieving clinically meaningful endoscopic improvement (reduction of more than or equal to 3 points from baseline in Simplified Endoscopic Activity Score for Crohn's Disease (SES-CD) at Week 12","12 weeks",null,"Number of participants with potentially clinically important serious infections findings|Mean change from baseline in SES-CD score at Week 12.|Proportion of subjects achieving SES-CD 25 and SES-CD 50 at Week 12.|Proportion of subjects achieving endoscopic remission (SES-CD less than or equal to 2) at Week 12.|Proportion of subjects achieving mucosal healing at Week 12.|Number of subjects with adverse events|Number of subjects with serious adverse events|Number of subjects with electrocardiogram findings of potential clinical importance.|Number of subjects withdrawal due to adverse events|Number of subjects with vital signs findings of potential clinical importance.|Number of subjects with laboratory tests findings of potential clinical importance.","64 weeks|Baseline, week 12|Number of subjects achieving SES-CD 25 and SES-CD 50 at Week 12.|Number of subjects achieving endoscopic remission (SES-CD less than or equal to 2) at Week 12.|Number of subjects achieving mucosal healing at Week 12.|Number of participants with reported adverse events|Number of participants with reported serious adverse events|Number of participants with potentially clinically important electrocardiogram findings.|Number of subjects withdrawal due to adverse events.|Number of participants with potentially clinically important vital signs findings.|Number of participants with potentially clinically important laboratory findings.","Baseline, week 12|Week 12|Baseline up to 64 weeks|Baseline u to 64 weeks","ClinicalTrials.gov_Inquiries@pfizer.com","Pfizer CT.gov Call Center","1-800-718-1021","Beverly Hills, California, United States, 90210 Long Beach Clinical Trial Services, Inc.Long Beach, California, United States, 90806 Entertainment Medical GroupLos Angeles, California, United States, 90036 Gastrointestinal Biosciences Clinical Trials, LlcLos Angeles, California, United States, 90067|Orlando, Florida, United States, 32811 Hmd Research LlcOrlando, Florida, United States, 32819 Orlando Gastroenterology, PaOrlando, Florida, United States, 32835|Chevy Chase, Maryland, United States, 20815 Mgg Group Co., Inc., Chevy Chase Clinical ResearchChevy Chase, Maryland, United States, 20815|Chesterfield, Michigan, United States, 48047 Eastside Endoscopy CenterMacomb, Michigan, United States, 48044|North Massapequa, New York, United States, 11758-1802|Kingsport, Tennessee, United States, 37660 Holston Medical GroupKingsport, Tennessee, United States, 37660 Holston Valley Surgery Center (Testing Only)Kingsport, Tennessee, United States, 37660|Houston, Texas, United States, 77098 Lonestar Endoscopy, Llp (Endoscopy Location)Southlake, Texas, United States, 76092 Texas Digestive Disease Consultants (Admin, Regulatory)Southlake, Texas, United States, 76092 Texas Digestive Disease ConsultantsSouthlake, Texas, United States, 76092|Fairfax, Virginia, United States, 22031","California|Florida|Maryland|Michigan|New York|Tennessee|Texas|Virginia","United States","Brighton Surgical Center|Millenia Surgery Center|Chevy Chase Endoscopy Center|Clinical Research Institute Of Michigan, Llc|Digiovanna Institute For Medical Education & Research|Holston Medical Group (Drug Shipment Only)|Gulf Coast Research Group, Llc|Verity Research, Inc.",{"$nulls":3},"Pfizer CT.gov Call Center","2018-04-02","2020-05-25T16:36:02.256","2020-05-26T17:10:42.972","NCT03395184"]
["5ecbf3f2fe30261b1a048208","NCT03395184","2018-04-26","Pfizer","PFE","Recruiting","Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PFâ€‘06700841 In Subjects With Moderate To Severe Crohn's Disease","Brepocitinib|Pf-06651600","JAK1 Inhibitor|TYK2 Inhibitor|JAK1 Inhibitor|JAK3 Inhibitor","Yes","['Brepocitinib', 'Pf-06651600']","Yes","['TYK2 Inhibitor', 'JAK3 Inhibitor']","Phase 2",2,250,"Anticipated","2018-02-05","2020-02-04","DAS","Disease Activity Score",{"$nulls":3},"The objectives of this study are to evaluate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-06651600 (200 mg for 8 weeks followed by 50 mg for 4 weeks) dosed once daily and PF-06700841 (60 mg for 12 weeks) dosed once daily during an induction period of 12 weeks, followed by an open label extension period at doses of 50 mg and 30 mg of PF 06651600 and PF 06700841, respectively, for 52 weeks.",null,"A PHASE 2A, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ORAL PF-06651600 AND PF-06700841 AS INDUCTION AND OPEN LABEL EXTENSION TREATMENT IN SUBJECTS WITH MODERATE TO SEVERE CROHN'S DISEASE","B7981007","Crohn's Disease","Crohn Disease","Gastrointestinal Diseases","Gastrointestinal","Experimental","PF-06700841 or placebo|PF-06651600 or placebo",null,"Drug","Placebo PF-06700841|PF-06700841|Placebo PF-06651600|PF-06651600","12 weeks, followed by PF-06700841, 30 mg QD for 52 weeks.|60 mg QD for 12 weeks followed by 30 mg QD for up to 52 weeks|12 weeks, followed by PF-06651600, 50 mg QD for 52 weeks|200 mg QD for 8 weeks, followed by 50 mg QD up to 56 weeks",null,"PF-06700841 or placebo|PF-06651600 or placebo","\n\n 1. Male and/or female subjects 18 years to 75 years of age\n 2. Documented diagnosis of ileal, ileocolonic, or colonic CD with a minimum disease duration of 3 months, as determined by endoscopic and histopathology assessment.\n 3. Endoscopic confirmation of active disease with total SES CD total score of at least 7. For isolated ileal disease, SES CD total score should be at least 4.\n 4. An average daily liquid/soft stool frequency (SF) greater than or equal to 2.5 or daily abdominal pain (AP) greater than or equal to 2.0.\n 5. Must have inadequate response to, loss of response to, or intolerance to at least one conventional therapy for CD:â€¢Steroids; Immunosuppressants (azathioprine [AZA], 6 MP, or methotrexate [MTX]); Anti TNF inhibitors (infliximab, adalimumab,certolizumab); Anti integrin inhibitors (eg, vedolizumab); Anti IL 12/23 inhibitor (ustekinumab).\n    \n    \n 6. Subjects currently receiving the following treatment for CD are eligible providing they have been on stable doses as described below: * Oral corticosteroids (prednisone or equivalent up to 25 mg/day; budesonide up to 9 mg/day). Stable dose for at least 2 weeks prior to baseline. If oral corticosteroids have been recently discontinued, they must have been stopped at least 2 weeks prior to baseline. Decreases in steroid use due to AEs are allowed.\n     * Oral 5 ASA or sulfasalazine are allowed providing that the dose is stable for at least 4 weeks prior to baseline.\n     * Crohn's disease related antibiotics are allowed providing that the dose is stable for at least 4 weeks prior to baseline. If antibiotics are stopped prior to baseline, they must be discontinued at least 4 days prior to baseline.\n    \n    \n\n","\n\n 1.  Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, diverticular disease, ulcerative colitis (UC), or clinical findings suggestive of UC.\n 2.  Presence of active (draining) fistulae or intra abdominal or perineal abscesses.\n 3.  Strictures with obstructive symptoms.\n 4.  Short bowel syndrome.\n 5.  History of bowel perforation requiring surgical intervention within the past 12 months.\n 6.  Previous bowel surgery resulting in an existing stoma. Subjects who have a j pouch are excluded, as a j pouch can result in a stoma.\n 7.  History of bowel surgery within 6 months prior to baseline.\n 8.  Subjects displaying clinical signs of fulminant colitis or toxic megacolon.\n 9.  Subjects with primary sclerosing cholangitis.\n 10. Subjects with evidence of colonic adenomas, dysplasia or neoplasia.\n 11. Abnormal findings on the chest x ray film such as presence of tuberculosis (TB), general infections, heart failure, or malignancy.\n 12. Any history of either untreated or inadequately treated latent or active TB infection, current treatment for active or latent TB infection or evidence of currently active TB by chest x ray, residing with or frequent close contact with individual(s) with active TB.\n 13. Subjects receiving the following therapies within the time period described below or expected to receive any of these therapies during the study period: 1.  >9 mg/day of oral budesonide or >25 mg/day of prednisone or equivalent oral systemic corticosteroid dose within 2 weeks prior to baseline.\n      2.  IV, IM (parenteral), or topical (rectal) treatment of 5 ASA or corticosteroid enemas/suppositories within 2 weeks prior to baseline.\n      3.  Azathioprine, 6 mercaptopurine, or methotrexate within 2 weeks prior to baseline.\n      4.  Anti TNF inhibitors (or biosimilars thereof) as described below: * Infliximab within 8 weeks prior to baseline;\n           * Adalimumab within 8 weeks prior to baseline;\n           * Certolizumab within 8 weeks prior to baseline;\n          \n          \n      5.  Anti integrin inhibitors (eg, vedolizumab) within 8 weeks prior to baseline.\n      6.  Ustekinumab within 8 weeks prior to baseline.\n      7.  Interferon therapy within 8 weeks prior to baseline.\n      8.  Subjects with prior treatment with lymphocyte depleting agents/therapies within 1 year prior to baseline (eg, CamPath[alemtuzumab], alkylating agents [eg, cyclophosphamide or chlorambucil], total lymphoid irradiation, etc).\n      9.  Subjects who have received rituximab or other selective B lymphocyte depleting agents within 1 year prior to baseline.\n      10. Subjects previously receiving leukocyte apheresis, including selective lymphocyte, monocyte, or granulocyte apheresis, or plasma exchange within 6 months prior to baseline.\n      11. Other marketed immunosuppressants or biologics with immunomodulatory properties within 3 months prior to baseline.\n      12. Subjects who have received other JAK inhibitors within 3 months prior to baseline.\n      13. Subjects who have not responded to or have been intolerant of other JAK inhibitors.\n      14. Other investigational procedures(s) or product(s), such as immunosuppressants used in transplantation (eg, mycophenolate mofetil, cyclosporine, rapamycin, or tacrolimus) or live (attenuated) vaccine within 30 days prior to baseline.","TNF","tumor necrosis factor","Protein","Lung, Breast, Ovary","Actual","2018-01-10","Actual","Anticipated","2021-02-18","Anticipated","2018-04-01","2017-12-05","2018-01-03","2018-04-25","Yes",null,"Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years","75 Years","All",null,"No","Yes\nInformation relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests",null,"URL: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7981007&StudyName=A+Phase+2a%2C+Double-blind%2C+Randomized%2C+Placebo-controlled%2C+Parallel+Group+Study+To+Evaluate+The+Efficacy+And+Safety+Of+Oral+Pf-06651600+And+Pf-06700841+As+Induction+And+Open+Label+Extension+Treatment+In+Subjects+With+Moderate+To+Severe+Crohn%E2%80%99s+Disease [https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7981007&StudyName=A+Phase+2a%2C+Double-blind%2C+Randomized%2C+Placebo-controlled%2C+Parallel+Group+Study+To+Evaluate+The+Efficacy+And+Safety+Of+Oral+Pf-06651600+And+Pf-06700841+As+Induction+And+Open+Label+Extension+Treatment+In+Subjects+With+Moderate+To+Severe+Crohn%E2%80%99s+Disease] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To obtain contact information for a study center near you, click here.",null,"Yes","No",{"$nulls":17},"2017-003359-43|PIZZICATO","EudraCT Number|Alias Study Number","Proportion of subjects achieving clinically meaningful endoscopic improvement (reduction of more than or equal to 3 points from baseline in Simplified Endoscopic Activity Score for Crohn's Disease (SES-CD) at Week 12","12 weeks",null,"Number of participants with potentially clinically important serious infections findings|Mean change from baseline in SES-CD score at Week 12.|Proportion of subjects achieving SES-CD 25 and SES-CD 50 at Week 12.|Proportion of subjects achieving endoscopic remission (SES-CD less than or equal to 2) at Week 12.|Proportion of subjects achieving mucosal healing at Week 12.|Number of subjects with adverse events|Number of subjects with serious adverse events|Number of subjects with electrocardiogram findings of potential clinical importance.|Number of subjects withdrawal due to adverse events|Number of subjects with vital signs findings of potential clinical importance.|Number of subjects with laboratory tests findings of potential clinical importance.|Proportion of subjects achieving SES CD 25 and SES CD 50 at Week 64 among subjects who achieved SES CD 25 and SES CD 50 at week 12 respectively.|Proportion of subjects achieving clinically meaningful endoscopic improvement (CMEI response) at week 64 among subjects who achieved CMEI response at Week 12.","64 weeks|Baseline, week 12|Number of subjects achieving SES-CD 25 and SES-CD 50 at Week 12.|Number of subjects achieving endoscopic remission (SES-CD less than or equal to 2) at Week 12.|Number of subjects achieving mucosal healing at Week 12.|Number of participants with reported adverse events|Number of participants with reported serious adverse events|Number of participants with potentially clinically important electrocardiogram findings.|Number of subjects withdrawal due to adverse events.|Number of participants with potentially clinically important vital signs findings.|Number of participants with potentially clinically important laboratory findings.|Number of subjects achieving SES-CD 25 and SES-CD 50 at Week 64 among subjects who achieved SES CD 25 and SES CD 50 at week 12|Number of subject achieving clinically meaningful endoscopic improvement (CMEI response) at week 64 among subjects who achieved CMEI response at week 12.","Baseline, week 12|Week 12|Baseline up to 64 weeks|Baseline u to 64 weeks|week 64","ClinicalTrials.gov_Inquiries@pfizer.com","Pfizer CT.gov Call Center","1-800-718-1021","Beverly Hills, California, United States, 90210 Long Beach Clinical Trial Services, Inc.Long Beach, California, United States, 90806 Entertainment Medical GroupLos Angeles, California, United States, 90036 Gastrointestinal Biosciences Clinical Trials, LlcLos Angeles, California, United States, 90067|Orlando, Florida, United States, 32811 Hmd Research LlcOrlando, Florida, United States, 32819 Orlando Gastroenterology, PaOrlando, Florida, United States, 32835|Chevy Chase, Maryland, United States, 20815 Mgg Group Co., Inc., Chevy Chase Clinical ResearchChevy Chase, Maryland, United States, 20815|Chesterfield, Michigan, United States, 48047 Eastside Endoscopy CenterMacomb, Michigan, United States, 48044|North Massapequa, New York, United States, 11758-1802|Winston-Salem, North Carolina, United States, 27103 Pmg Research Of Winston-Salem, LlcWinston-Salem, North Carolina, United States, 27103|Kingsport, Tennessee, United States, 37660 Holston Medical GroupKingsport, Tennessee, United States, 37660 Holston Valley Surgery Center (Testing Only)Kingsport, Tennessee, United States, 37660|Houston, Texas, United States, 77098 Lonestar Endoscopy, Llp (Endoscopy Location)Southlake, Texas, United States, 76092 Texas Digestive Disease Consultants (Admin, Regulatory)Southlake, Texas, United States, 76092 Texas Digestive Disease ConsultantsSouthlake, Texas, United States, 76092|Fairfax, Virginia, United States, 22031","California|Florida|Maryland|Michigan|New York|North Carolina|Tennessee|Texas|Virginia","United States","Brighton Surgical Center|Millenia Surgery Center|Chevy Chase Endoscopy Center|Clinical Research Institute Of Michigan, Llc|Digiovanna Institute For Medical Education & Research|Gastroenterology Associates Of The Piedmont, Pa|Holston Medical Group (Drug Shipment Only)|Gulf Coast Research Group, Llc|Verity Research, Inc.",{"$nulls":3},"Pfizer CT.gov Call Center","2018-04-25","2020-05-25T16:36:02.298","2020-05-26T17:10:42.972","NCT03395184"]
["5ecbf3f2feab101b15530838","NCT03395184","2018-05-18","Pfizer","PFE","Recruiting","Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PFâ€‘06700841 In Subjects With Moderate To Severe Crohn's Disease","Brepocitinib|Pf-06651600","JAK1 Inhibitor|TYK2 Inhibitor|JAK1 Inhibitor|JAK3 Inhibitor","Yes","['Brepocitinib', 'Pf-06651600']","Yes","['TYK2 Inhibitor', 'JAK3 Inhibitor']","Phase 2",2,250,"Anticipated","2018-02-05","2020-02-04","DAS","Disease Activity Score",{"$nulls":3},"The objectives of this study are to evaluate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-06651600 (200 mg for 8 weeks followed by 50 mg for 4 weeks) dosed once daily and PF-06700841 (60 mg for 12 weeks) dosed once daily during an induction period of 12 weeks, followed by an open label extension period at doses of 50 mg and 30 mg of PF 06651600 and PF 06700841, respectively, for 52 weeks.",null,"A PHASE 2A, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ORAL PF-06651600 AND PF-06700841 AS INDUCTION AND OPEN LABEL EXTENSION TREATMENT IN SUBJECTS WITH MODERATE TO SEVERE CROHN'S DISEASE","B7981007","Crohn's Disease","Crohn Disease","Gastrointestinal Diseases","Gastrointestinal","Experimental","PF-06700841 or placebo|PF-06651600 or placebo",null,"Drug","Placebo PF-06700841|PF-06700841|Placebo PF-06651600|PF-06651600","12 weeks, followed by PF-06700841, 30 mg QD for 52 weeks.|60 mg QD for 12 weeks followed by 30 mg QD for up to 52 weeks|12 weeks, followed by PF-06651600, 50 mg QD for 52 weeks|200 mg QD for 8 weeks, followed by 50 mg QD up to 56 weeks",null,"PF-06700841 or placebo|PF-06651600 or placebo","\n\n 1. Male and/or female subjects 18 years to 75 years of age\n 2. Documented diagnosis of ileal, ileocolonic, or colonic CD with a minimum disease duration of 3 months, as determined by endoscopic and histopathology assessment.\n 3. Endoscopic confirmation of active disease with total SES CD total score of at least 7. For isolated ileal disease, SES CD total score should be at least 4.\n 4. An average daily liquid/soft stool frequency (SF) greater than or equal to 2.5 or daily abdominal pain (AP) greater than or equal to 2.0.\n 5. Must have inadequate response to, loss of response to, or intolerance to at least one conventional therapy for CD:â€¢Steroids; Immunosuppressants (azathioprine [AZA], 6 MP, or methotrexate [MTX]); Anti TNF inhibitors (infliximab, adalimumab,certolizumab); Anti integrin inhibitors (eg, vedolizumab); Anti IL 12/23 inhibitor (ustekinumab).\n    \n    \n 6. Subjects currently receiving the following treatment for CD are eligible providing they have been on stable doses as described below: * Oral corticosteroids (prednisone or equivalent up to 25 mg/day; budesonide up to 9 mg/day). Stable dose for at least 2 weeks prior to baseline. If oral corticosteroids have been recently discontinued, they must have been stopped at least 2 weeks prior to baseline. Decreases in steroid use due to AEs are allowed.\n     * Oral 5 ASA or sulfasalazine are allowed providing that the dose is stable for at least 4 weeks prior to baseline.\n     * Crohn's disease related antibiotics are allowed providing that the dose is stable for at least 4 weeks prior to baseline. If antibiotics are stopped prior to baseline, they must be discontinued at least 4 days prior to baseline.\n    \n    \n\n","\n\n 1.  Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, diverticular disease, ulcerative colitis (UC), or clinical findings suggestive of UC.\n 2.  Presence of active (draining) fistulae or intra abdominal or perineal abscesses.\n 3.  Strictures with obstructive symptoms.\n 4.  Short bowel syndrome.\n 5.  History of bowel perforation requiring surgical intervention within the past 12 months.\n 6.  Previous bowel surgery resulting in an existing stoma. Subjects who have a j pouch are excluded, as a j pouch can result in a stoma.\n 7.  History of bowel surgery within 6 months prior to baseline.\n 8.  Subjects displaying clinical signs of fulminant colitis or toxic megacolon.\n 9.  Subjects with primary sclerosing cholangitis.\n 10. Subjects with evidence of colonic adenomas, dysplasia or neoplasia.\n 11. Abnormal findings on the chest x ray film such as presence of tuberculosis (TB), general infections, heart failure, or malignancy.\n 12. Any history of either untreated or inadequately treated latent or active TB infection, current treatment for active or latent TB infection or evidence of currently active TB by chest x ray, residing with or frequent close contact with individual(s) with active TB.\n 13. Subjects receiving the following therapies within the time period described below or expected to receive any of these therapies during the study period: 1.  >9 mg/day of oral budesonide or >25 mg/day of prednisone or equivalent oral systemic corticosteroid dose within 2 weeks prior to baseline.\n      2.  IV, IM (parenteral), or topical (rectal) treatment of 5 ASA or corticosteroid enemas/suppositories within 2 weeks prior to baseline.\n      3.  Azathioprine, 6 mercaptopurine, or methotrexate within 2 weeks prior to baseline.\n      4.  Anti TNF inhibitors (or biosimilars thereof) as described below: * Infliximab within 8 weeks prior to baseline;\n           * Adalimumab within 8 weeks prior to baseline;\n           * Certolizumab within 8 weeks prior to baseline;\n          \n          \n      5.  Anti integrin inhibitors (eg, vedolizumab) within 8 weeks prior to baseline.\n      6.  Ustekinumab within 8 weeks prior to baseline.\n      7.  Interferon therapy within 8 weeks prior to baseline.\n      8.  Subjects with prior treatment with lymphocyte depleting agents/therapies within 1 year prior to baseline (eg, CamPath[alemtuzumab], alkylating agents [eg, cyclophosphamide or chlorambucil], total lymphoid irradiation, etc).\n      9.  Subjects who have received rituximab or other selective B lymphocyte depleting agents within 1 year prior to baseline.\n      10. Subjects previously receiving leukocyte apheresis, including selective lymphocyte, monocyte, or granulocyte apheresis, or plasma exchange within 6 months prior to baseline.\n      11. Other marketed immunosuppressants or biologics with immunomodulatory properties within 3 months prior to baseline.\n      12. Subjects who have received other JAK inhibitors within 3 months prior to baseline.\n      13. Subjects who have not responded to or have been intolerant of other JAK inhibitors.\n      14. Other investigational procedures(s) or product(s), such as immunosuppressants used in transplantation (eg, mycophenolate mofetil, cyclosporine, rapamycin, or tacrolimus) or live (attenuated) vaccine within 30 days prior to baseline.","TNF","tumor necrosis factor","Protein","Lung, Breast, Ovary","Actual","2018-01-10","Actual","Anticipated","2021-02-18","Anticipated","2018-05-01","2017-12-05","2018-01-03","2018-05-17","Yes",null,"Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years","75 Years","All",null,"No","Yes\nInformation relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests",null,"URL: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7981007&StudyName=A+Phase+2a%2C+Double-blind%2C+Randomized%2C+Placebo-controlled%2C+Parallel+Group+Study+To+Evaluate+The+Efficacy+And+Safety+Of+Oral+Pf-06651600+And+Pf-06700841+As+Induction+And+Open+Label+Extension+Treatment+In+Subjects+With+Moderate+To+Severe+Crohn%E2%80%99s+Disease [https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7981007&StudyName=A+Phase+2a%2C+Double-blind%2C+Randomized%2C+Placebo-controlled%2C+Parallel+Group+Study+To+Evaluate+The+Efficacy+And+Safety+Of+Oral+Pf-06651600+And+Pf-06700841+As+Induction+And+Open+Label+Extension+Treatment+In+Subjects+With+Moderate+To+Severe+Crohn%E2%80%99s+Disease] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To obtain contact information for a study center near you, click here.",null,"Yes","No",{"$nulls":17},"2017-003359-43|PIZZICATO","EudraCT Number|Alias Study Number","Proportion of subjects achieving clinically meaningful endoscopic improvement (reduction of more than or equal to 3 points from baseline in Simplified Endoscopic Activity Score for Crohn's Disease (SES-CD) at Week 12","12 weeks",null,"Number of participants with potentially clinically important serious infections findings|Mean change from baseline in SES-CD score at Week 12.|Proportion of subjects achieving SES-CD 25 and SES-CD 50 at Week 12.|Proportion of subjects achieving endoscopic remission (SES-CD less than or equal to 2) at Week 12.|Proportion of subjects achieving mucosal healing at Week 12.|Number of subjects with adverse events|Number of subjects with serious adverse events|Number of subjects with electrocardiogram findings of potential clinical importance.|Number of subjects withdrawal due to adverse events|Number of subjects with vital signs findings of potential clinical importance.|Number of subjects with laboratory tests findings of potential clinical importance.|Proportion of subjects achieving SES CD 25 and SES CD 50 at Week 64 among subjects who achieved SES CD 25 and SES CD 50 at week 12 respectively.|Proportion of subjects achieving clinically meaningful endoscopic improvement (CMEI response) at week 64 among subjects who achieved CMEI response at Week 12.","64 weeks|Baseline, week 12|Number of subjects achieving SES-CD 25 and SES-CD 50 at Week 12.|Number of subjects achieving endoscopic remission (SES-CD less than or equal to 2) at Week 12.|Number of subjects achieving mucosal healing at Week 12.|Number of participants with reported adverse events|Number of participants with reported serious adverse events|Number of participants with potentially clinically important electrocardiogram findings.|Number of subjects withdrawal due to adverse events.|Number of participants with potentially clinically important vital signs findings.|Number of participants with potentially clinically important laboratory findings.|Number of subjects achieving SES-CD 25 and SES-CD 50 at Week 64 among subjects who achieved SES CD 25 and SES CD 50 at week 12|Number of subject achieving clinically meaningful endoscopic improvement (CMEI response) at week 64 among subjects who achieved CMEI response at week 12.","Baseline, week 12|Week 12|Baseline up to 64 weeks|Baseline u to 64 weeks|week 64","ClinicalTrials.gov_Inquiries@pfizer.com","Pfizer CT.gov Call Center","1-800-718-1021","Tbilisi, Georgia, 0141 David Tatishvili Medical CenterTbilisi, Georgia, 0186 Korea, Republic Of, Korea Kyungpook National University HospitalDaegu, Korea, Korea, Republic Of, 41944|Beverly Hills, California, United States, 90210 Long Beach Clinical Trial Services, Inc.Long Beach, California, United States, 90806 Entertainment Medical GroupLos Angeles, California, United States, 90036 Gastrointestinal Biosciences Clinical Trials, LlcLos Angeles, California, United States, 90067|Clearwater, Florida, United States, 33756-3839 West Coast Endoscopy CenterClearwater, Florida, United States, 33756 Gastro Florida (Regulatory & Administrative Duties)Clearwater, Florida, United States, 33762 Millenia Surgery CenterOrlando, Florida, United States, 32811 Hmd Research LlcOrlando, Florida, United States, 32819 Orlando Gastroenterology, PaOrlando, Florida, United States, 32835|Chevy Chase, Maryland, United States, 20815 Mgg Group Co., Inc., Chevy Chase Clinical ResearchChevy Chase, Maryland, United States, 20815|Chesterfield, Michigan, United States, 48047 Eastside Endoscopy CenterMacomb, Michigan, United States, 48044|North Massapequa, New York, United States, 11758-1802|Winston-Salem, North Carolina, United States, 27103 Pmg Research Of Winston-Salem, LlcWinston-Salem, North Carolina, United States, 27103|Kingsport, Tennessee, United States, 37660 Holston Medical GroupKingsport, Tennessee, United States, 37660 Holston Valley Surgery Center (Testing Only)Kingsport, Tennessee, United States, 37660|Houston, Texas, United States, 77004 Pearland Surgery CenterHouston, Texas, United States, 77047 Gulf Coast Research Group, LlcHouston, Texas, United States, 77098 Lonestar Endoscopy, LlpSouthlake, Texas, United States, 76092 Texas Digestive Disease ConsultantsSouthlake, Texas, United States, 76092|Fairfax, Virginia, United States, 22031","California|Florida|Maryland|Michigan|New York|North Carolina|Tennessee|Texas|Virginia","Georgia|United States","The First University Clinic Of Tsmu|Brighton Surgical Center|Gastro Florida|Chevy Chase Endoscopy Center|Clinical Research Institute Of Michigan, Llc|Digiovanna Institute For Medical Education & Research|Gastroenterology Associates Of The Piedmont, Pa|Holston Medical Group (Drug Shipment Only)|Hermann Drive Surgical Hospital|Verity Research, Inc.",{"$nulls":3},"Pfizer CT.gov Call Center","2018-05-17","2020-05-25T16:36:02.538","2020-05-26T17:10:42.972","NCT03395184"]
["5ecbf3f211702c1b1b916a1a","NCT03395184","2018-06-06","Pfizer","PFE","Recruiting","Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PFâ€‘06700841 In Subjects With Moderate To Severe Crohn's Disease","Brepocitinib|Pf-06651600","JAK1 Inhibitor|TYK2 Inhibitor|JAK1 Inhibitor|JAK3 Inhibitor","Yes","['Brepocitinib', 'Pf-06651600']","Yes","['TYK2 Inhibitor', 'JAK3 Inhibitor']","Phase 2",2,250,"Anticipated","2018-02-05","2020-02-04","DAS","Disease Activity Score",{"$nulls":3},"The objectives of this study are to evaluate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-06651600 (200 mg for 8 weeks followed by 50 mg for 4 weeks) dosed once daily and PF-06700841 (60 mg for 12 weeks) dosed once daily during an induction period of 12 weeks, followed by an open label extension period at doses of 50 mg and 30 mg of PF 06651600 and PF 06700841, respectively, for 52 weeks.",null,"A PHASE 2A, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ORAL PF-06651600 AND PF-06700841 AS INDUCTION AND OPEN LABEL EXTENSION TREATMENT IN SUBJECTS WITH MODERATE TO SEVERE CROHN'S DISEASE","B7981007","Crohn's Disease","Crohn Disease","Gastrointestinal Diseases","Gastrointestinal","Experimental","PF-06700841 or placebo|PF-06651600 or placebo",null,"Drug","Placebo PF-06700841|PF-06700841|Placebo PF-06651600|PF-06651600","12 weeks, followed by PF-06700841, 30 mg QD for 52 weeks.|60 mg QD for 12 weeks followed by 30 mg QD for up to 52 weeks|12 weeks, followed by PF-06651600, 50 mg QD for 52 weeks|200 mg QD for 8 weeks, followed by 50 mg QD up to 56 weeks",null,"PF-06700841 or placebo|PF-06651600 or placebo","\n\n 1. Male and/or female subjects 18 years to 75 years of age\n 2. Documented diagnosis of ileal, ileocolonic, or colonic CD with a minimum disease duration of 3 months, as determined by endoscopic and histopathology assessment.\n 3. Endoscopic confirmation of active disease with total SES CD total score of at least 7. For isolated ileal disease, SES CD total score should be at least 4.\n 4. An average daily liquid/soft stool frequency (SF) greater than or equal to 2.5 or daily abdominal pain (AP) greater than or equal to 2.0.\n 5. Must have inadequate response to, loss of response to, or intolerance to at least one conventional therapy for CD:â€¢Steroids; Immunosuppressants (azathioprine [AZA], 6 MP, or methotrexate [MTX]); Anti TNF inhibitors (infliximab, adalimumab,certolizumab); Anti integrin inhibitors (eg, vedolizumab); Anti IL 12/23 inhibitor (ustekinumab).\n    \n    \n 6. Subjects currently receiving the following treatment for CD are eligible providing they have been on stable doses as described below: * Oral corticosteroids (prednisone or equivalent up to 25 mg/day; budesonide up to 9 mg/day). Stable dose for at least 2 weeks prior to baseline. If oral corticosteroids have been recently discontinued, they must have been stopped at least 2 weeks prior to baseline. Decreases in steroid use due to AEs are allowed.\n     * Oral 5 ASA or sulfasalazine are allowed providing that the dose is stable for at least 4 weeks prior to baseline.\n     * Crohn's disease related antibiotics are allowed providing that the dose is stable for at least 4 weeks prior to baseline. If antibiotics are stopped prior to baseline, they must be discontinued at least 4 days prior to baseline.\n    \n    \n\n","\n\n 1.  Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, diverticular disease, ulcerative colitis (UC), or clinical findings suggestive of UC.\n 2.  Presence of active (draining) fistulae or intra abdominal or perineal abscesses.\n 3.  Strictures with obstructive symptoms.\n 4.  Short bowel syndrome.\n 5.  History of bowel perforation requiring surgical intervention within the past 12 months.\n 6.  Previous bowel surgery resulting in an existing stoma. Subjects who have a j pouch are excluded, as a j pouch can result in a stoma.\n 7.  History of bowel surgery within 6 months prior to baseline.\n 8.  Subjects displaying clinical signs of fulminant colitis or toxic megacolon.\n 9.  Subjects with primary sclerosing cholangitis.\n 10. Subjects with evidence of colonic adenomas, dysplasia or neoplasia.\n 11. Abnormal findings on the chest x ray film such as presence of tuberculosis (TB), general infections, heart failure, or malignancy.\n 12. Any history of either untreated or inadequately treated latent or active TB infection, current treatment for active or latent TB infection or evidence of currently active TB by chest x ray, residing with or frequent close contact with individual(s) with active TB.\n 13. Subjects receiving the following therapies within the time period described below or expected to receive any of these therapies during the study period: 1.  >9 mg/day of oral budesonide or >25 mg/day of prednisone or equivalent oral systemic corticosteroid dose within 2 weeks prior to baseline.\n      2.  IV, IM (parenteral), or topical (rectal) treatment of 5 ASA or corticosteroid enemas/suppositories within 2 weeks prior to baseline.\n      3.  Azathioprine, 6 mercaptopurine, or methotrexate within 2 weeks prior to baseline.\n      4.  Anti TNF inhibitors (or biosimilars thereof) as described below: * Infliximab within 8 weeks prior to baseline;\n           * Adalimumab within 8 weeks prior to baseline;\n           * Certolizumab within 8 weeks prior to baseline;\n          \n          \n      5.  Anti integrin inhibitors (eg, vedolizumab) within 8 weeks prior to baseline.\n      6.  Ustekinumab within 8 weeks prior to baseline.\n      7.  Interferon therapy within 8 weeks prior to baseline.\n      8.  Subjects with prior treatment with lymphocyte depleting agents/therapies within 1 year prior to baseline (eg, CamPath[alemtuzumab], alkylating agents [eg, cyclophosphamide or chlorambucil], total lymphoid irradiation, etc).\n      9.  Subjects who have received rituximab or other selective B lymphocyte depleting agents within 1 year prior to baseline.\n      10. Subjects previously receiving leukocyte apheresis, including selective lymphocyte, monocyte, or granulocyte apheresis, or plasma exchange within 6 months prior to baseline.\n      11. Other marketed immunosuppressants or biologics with immunomodulatory properties within 3 months prior to baseline.\n      12. Subjects who have received other JAK inhibitors within 3 months prior to baseline.\n      13. Subjects who have not responded to or have been intolerant of other JAK inhibitors.\n      14. Other investigational procedures(s) or product(s), such as immunosuppressants used in transplantation (eg, mycophenolate mofetil, cyclosporine, rapamycin, or tacrolimus) or live (attenuated) vaccine within 30 days prior to baseline.","TNF","tumor necrosis factor","Protein","Lung, Breast, Ovary","Actual","2018-01-10","Actual","Anticipated","2021-02-18","Anticipated","2018-06-01","2017-12-05","2018-01-03","2018-06-05","Yes",null,"Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years","75 Years","All",null,"No","Yes\nInformation relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests",null,"URL: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7981007&StudyName=A+Phase+2a%2C+Double-blind%2C+Randomized%2C+Placebo-controlled%2C+Parallel+Group+Study+To+Evaluate+The+Efficacy+And+Safety+Of+Oral+Pf-06651600+And+Pf-06700841+As+Induction+And+Open+Label+Extension+Treatment+In+Subjects+With+Moderate+To+Severe+Crohn%E2%80%99s+Disease [https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7981007&StudyName=A+Phase+2a%2C+Double-blind%2C+Randomized%2C+Placebo-controlled%2C+Parallel+Group+Study+To+Evaluate+The+Efficacy+And+Safety+Of+Oral+Pf-06651600+And+Pf-06700841+As+Induction+And+Open+Label+Extension+Treatment+In+Subjects+With+Moderate+To+Severe+Crohn%E2%80%99s+Disease] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To obtain contact information for a study center near you, click here.",null,"Yes","No",{"$nulls":17},"2017-003359-43|PIZZICATO","EudraCT Number|Alias Study Number","Proportion of subjects achieving clinically meaningful endoscopic improvement (reduction of more than or equal to 3 points from baseline in Simplified Endoscopic Activity Score for Crohn's Disease (SES-CD) at Week 12","12 weeks",null,"Number of participants with potentially clinically important serious infections findings|Mean change from baseline in SES-CD score at Week 12.|Proportion of subjects achieving SES-CD 25 and SES-CD 50 at Week 12.|Proportion of subjects achieving endoscopic remission (SES-CD less than or equal to 2) at Week 12.|Proportion of subjects achieving mucosal healing at Week 12.|Number of subjects with adverse events|Number of subjects with serious adverse events|Number of subjects with electrocardiogram findings of potential clinical importance.|Number of subjects withdrawal due to adverse events|Number of subjects with vital signs findings of potential clinical importance.|Number of subjects with laboratory tests findings of potential clinical importance.|Proportion of subjects achieving SES CD 25 and SES CD 50 at Week 64 among subjects who achieved SES CD 25 and SES CD 50 at week 12 respectively.|Proportion of subjects achieving clinically meaningful endoscopic improvement (CMEI response) at week 64 among subjects who achieved CMEI response at Week 12.","64 weeks|Baseline, week 12|Number of subjects achieving SES-CD 25 and SES-CD 50 at Week 12.|Number of subjects achieving endoscopic remission (SES-CD less than or equal to 2) at Week 12.|Number of subjects achieving mucosal healing at Week 12.|Number of participants with reported adverse events|Number of participants with reported serious adverse events|Number of participants with potentially clinically important electrocardiogram findings.|Number of subjects withdrawal due to adverse events.|Number of participants with potentially clinically important vital signs findings.|Number of participants with potentially clinically important laboratory findings.|Number of subjects achieving SES-CD 25 and SES-CD 50 at Week 64 among subjects who achieved SES CD 25 and SES CD 50 at week 12|Number of subject achieving clinically meaningful endoscopic improvement (CMEI response) at week 64 among subjects who achieved CMEI response at week 12.","Baseline, week 12|Week 12|Baseline up to 64 weeks|Baseline u to 64 weeks|week 64","ClinicalTrials.gov_Inquiries@pfizer.com","Pfizer CT.gov Call Center","1-800-718-1021","Ballarat, Victoria, Australia, 3350|Tbilisi, Georgia, 0141 David Tatishvili Medical CenterTbilisi, Georgia, 0186 Korea, Republic Of, Korea Kyungpook National University HospitalDaegu, Korea, Korea, Republic Of, 41944 Korea, Republic Of Severance Hospital, Yonsei University Health SystemSeoul, Korea, Republic Of, 03722 Russian Federation Saint-Petersburg State Budgetary Healthcare Institution \"City Hospital #26\"Saint-Petersburg, Russian Federation, 196247|Santander, Cantabria, Spain, 39008|Madrid, Spain, 28034 Hospital Universitario Virgen Del RocioSevilla, Spain, 41013|Beverly Hills, California, United States, 90210 Long Beach Clinical Trial Services, Inc.Long Beach, California, United States, 90806 Entertainment Medical GroupLos Angeles, California, United States, 90036 Gastrointestinal Biosciences Clinical Trials, LlcLos Angeles, California, United States, 90067 Alliance Clinical Research, LlcPoway, California, United States, 92064|Clearwater, Florida, United States, 33756-3839 West Coast Endoscopy CenterClearwater, Florida, United States, 33756 Gastro Florida (Regulatory & Administrative Duties)Clearwater, Florida, United States, 33762 Millenia Surgery CenterOrlando, Florida, United States, 32811 Hmd Research LlcOrlando, Florida, United States, 32819 Orlando Gastroenterology, PaOrlando, Florida, United States, 32835|Houma, Louisiana, United States, 70360 Gulf Coast Surgical CenterHouma, Louisiana, United States, 70360 The Hearing Center (Audiology)Houma, Louisiana, United States, 70360|Chevy Chase, Maryland, United States, 20815 Mgg Group Co., Inc., Chevy Chase Clinical ResearchChevy Chase, Maryland, United States, 20815|Chesterfield, Michigan, United States, 48047 Eastside Endoscopy CenterMacomb, Michigan, United States, 48044|North Massapequa, New York, United States, 11758-1802|Chapel Hill, North Carolina, United States, 27514 Unc HospitalsChapel Hill, North Carolina, United States, 27514 Unc Hospitals Endoscopy Center At Meadowmont (Endoscopy Only)Chapel Hill, North Carolina, United States, 27517 University Of North Carolina At Chapel Hill (Administration)Chapel Hill, North Carolina, United States, 27599 University Of North Carolina At Chapel Hill (Study Visits)Chapel Hill, North Carolina, United States, 27599 Gastroenterology Associates Of The Piedmont, PaWinston-Salem, North Carolina, United States, 27103 Pmg Research Of Winston-Salem, LlcWinston-Salem, North Carolina, United States, 27103|Kingsport, Tennessee, United States, 37660 Holston Medical GroupKingsport, Tennessee, United States, 37660 Holston Valley Surgery Center (Testing Only)Kingsport, Tennessee, United States, 37660|Arlington, Texas, United States, 76012 Envision Imaging (Cxr)Arlington, Texas, United States, 76012 Texas Clinical Research Institiute, LlcArlington, Texas, United States, 76012 Hermann Drive Surgical HospitalHouston, Texas, United States, 77004 Pearland Surgery CenterHouston, Texas, United States, 77047 Gulf Coast Research Group, LlcHouston, Texas, United States, 77098 Lonestar Endoscopy, LlpSouthlake, Texas, United States, 76092 Texas Digestive Disease ConsultantsSouthlake, Texas, United States, 76092|Fairfax, Virginia, United States, 22031","California|Florida|Louisiana|Maryland|Michigan|New York|North Carolina|Tennessee|Texas|Virginia","Australia|Georgia|Spain|United States","Victoria Ballarat Base Hospital|The First University Clinic Of Tsmu|Cantabria Hospital Universitario Marques De Valdecilla|Hospital Universitario Ramon Y Cajal|Brighton Surgical Center|Gastro Florida|Cronola, Llc|Chevy Chase Endoscopy Center|Clinical Research Institute Of Michigan, Llc|Digiovanna Institute For Medical Education & Research|Unc Hospitals (Study Visits)|Holston Medical Group (Drug Shipment Only)|Cross Timbers Surgery Center L.P. (Colonoscopy)|Verity Research, Inc.",{"$nulls":3},"Pfizer CT.gov Call Center","2018-06-05","2020-05-25T16:36:02.828","2020-05-26T17:10:42.972","NCT03395184"]
["5ecbf3f2e2561b1b11905d04","NCT03395184","2018-07-03","Pfizer","PFE","Recruiting","Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PFâ€‘06700841 In Subjects With Moderate To Severe Crohn's Disease","Brepocitinib|Pf-06651600","JAK1 Inhibitor|TYK2 Inhibitor|JAK1 Inhibitor|JAK3 Inhibitor","Yes","['Brepocitinib', 'Pf-06651600']","Yes","['TYK2 Inhibitor', 'JAK3 Inhibitor']","Phase 2",2,250,"Anticipated","2018-02-02","2020-02-04","DAS","Disease Activity Score",{"$nulls":3},"The objectives of this study are to evaluate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-06651600 (200 mg for 8 weeks followed by 50 mg for 4 weeks) dosed once daily and PF-06700841 (60 mg for 12 weeks) dosed once daily during an induction period of 12 weeks, followed by an open label extension period at doses of 50 mg and 30 mg of PF 06651600 and PF 06700841, respectively, for 52 weeks.",null,"A PHASE 2A, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ORAL PF-06651600 AND PF-06700841 AS INDUCTION AND OPEN LABEL EXTENSION TREATMENT IN SUBJECTS WITH MODERATE TO SEVERE CROHN'S DISEASE","B7981007","Crohn's Disease","Crohn Disease","Gastrointestinal Diseases","Gastrointestinal","Experimental","PF-06700841 or placebo|PF-06651600 or placebo",null,"Drug","Placebo PF-06700841|PF-06700841|Placebo PF-06651600|PF-06651600","12 weeks, followed by PF-06700841, 30 mg QD for 52 weeks.|60 mg QD for 12 weeks followed by 30 mg QD for up to 52 weeks|12 weeks, followed by PF-06651600, 50 mg QD for 52 weeks|200 mg QD for 8 weeks, followed by 50 mg QD up to 56 weeks",null,"PF-06700841 or placebo|PF-06651600 or placebo","\n\n 1. Male and/or female subjects 18 years to 75 years of age\n 2. Documented diagnosis of ileal, ileocolonic, or colonic CD with a minimum disease duration of 3 months, as determined by endoscopic and histopathology assessment.\n 3. Endoscopic confirmation of active disease with total SES CD total score of at least 7. For isolated ileal disease, SES CD total score should be at least 4.\n 4. An average daily liquid/soft stool frequency (SF) greater than or equal to 2.5 or daily abdominal pain (AP) greater than or equal to 2.0.\n 5. Must have inadequate response to, loss of response to, or intolerance to at least one conventional therapy for CD:â€¢Steroids; Immunosuppressants (azathioprine [AZA], 6 MP, or methotrexate [MTX]); Anti TNF inhibitors (infliximab, adalimumab,certolizumab); Anti integrin inhibitors (eg, vedolizumab); Anti IL 12/23 inhibitor (ustekinumab).\n    \n    \n 6. Subjects currently receiving the following treatment for CD are eligible providing they have been on stable doses as described below: * Oral corticosteroids (prednisone or equivalent up to 25 mg/day; budesonide up to 9 mg/day). Stable dose for at least 2 weeks prior to baseline. If oral corticosteroids have been recently discontinued, they must have been stopped at least 2 weeks prior to baseline. Decreases in steroid use due to AEs are allowed.\n     * Oral 5 ASA or sulfasalazine are allowed providing that the dose is stable for at least 4 weeks prior to baseline.\n     * Crohn's disease related antibiotics are allowed providing that the dose is stable for at least 4 weeks prior to baseline. If antibiotics are stopped prior to baseline, they must be discontinued at least 4 days prior to baseline.\n    \n    \n\n","\n\n 1.  Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, diverticular disease, ulcerative colitis (UC), or clinical findings suggestive of UC.\n 2.  Presence of active (draining) fistulae or intra abdominal or perineal abscesses.\n 3.  Strictures with obstructive symptoms.\n 4.  Short bowel syndrome.\n 5.  History of bowel perforation requiring surgical intervention within the past 12 months.\n 6.  Previous bowel surgery resulting in an existing stoma. Subjects who have a j pouch are excluded, as a j pouch can result in a stoma.\n 7.  History of bowel surgery within 6 months prior to baseline.\n 8.  Subjects displaying clinical signs of fulminant colitis or toxic megacolon.\n 9.  Subjects with primary sclerosing cholangitis.\n 10. Subjects with evidence of colonic adenomas, dysplasia or neoplasia.\n 11. Abnormal findings on the chest x ray film such as presence of tuberculosis (TB), general infections, heart failure, or malignancy.\n 12. Any history of either untreated or inadequately treated latent or active TB infection, current treatment for active or latent TB infection or evidence of currently active TB by chest x ray, residing with or frequent close contact with individual(s) with active TB.\n 13. Subjects receiving the following therapies within the time period described below or expected to receive any of these therapies during the study period: 1.  >9 mg/day of oral budesonide or >25 mg/day of prednisone or equivalent oral systemic corticosteroid dose within 2 weeks prior to baseline.\n      2.  IV, IM (parenteral), or topical (rectal) treatment of 5 ASA or corticosteroid enemas/suppositories within 2 weeks prior to baseline.\n      3.  Azathioprine, 6 mercaptopurine, or methotrexate within 2 weeks prior to baseline.\n      4.  Anti TNF inhibitors (or biosimilars thereof) as described below: * Infliximab within 8 weeks prior to baseline;\n           * Adalimumab within 8 weeks prior to baseline;\n           * Certolizumab within 8 weeks prior to baseline;\n          \n          \n      5.  Anti integrin inhibitors (eg, vedolizumab) within 8 weeks prior to baseline.\n      6.  Ustekinumab within 8 weeks prior to baseline.\n      7.  Interferon therapy within 8 weeks prior to baseline.\n      8.  Subjects with prior treatment with lymphocyte depleting agents/therapies within 1 year prior to baseline (eg, CamPath[alemtuzumab], alkylating agents [eg, cyclophosphamide or chlorambucil], total lymphoid irradiation, etc).\n      9.  Subjects who have received rituximab or other selective B lymphocyte depleting agents within 1 year prior to baseline.\n      10. Subjects previously receiving leukocyte apheresis, including selective lymphocyte, monocyte, or granulocyte apheresis, or plasma exchange within 6 months prior to baseline.\n      11. Other marketed immunosuppressants or biologics with immunomodulatory properties within 3 months prior to baseline.\n      12. Subjects who have received other JAK inhibitors within 3 months prior to baseline.\n      13. Subjects who have not responded to or have been intolerant of other JAK inhibitors.\n      14. Other investigational procedures(s) or product(s), such as immunosuppressants used in transplantation (eg, mycophenolate mofetil, cyclosporine, rapamycin, or tacrolimus) or live (attenuated) vaccine within 30 days prior to baseline.","TNF","tumor necrosis factor","Protein","Lung, Breast, Ovary","Actual","2018-01-10","Actual","Anticipated","2021-02-18","Anticipated","2018-07-01","2017-12-05","2018-01-03","2018-07-02","Yes",null,"Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years","75 Years","All",null,"No","Yes\nInformation relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests",null,"URL: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7981007&StudyName=A+Phase+2a%2C+Double-blind%2C+Randomized%2C+Placebo-controlled%2C+Parallel+Group+Study+To+Evaluate+The+Efficacy+And+Safety+Of+Oral+Pf-06651600+And+Pf-06700841+As+Induction+And+Open+Label+Extension+Treatment+In+Subjects+With+Moderate+To+Severe+Crohn%E2%80%99s+Disease [https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7981007&StudyName=A+Phase+2a%2C+Double-blind%2C+Randomized%2C+Placebo-controlled%2C+Parallel+Group+Study+To+Evaluate+The+Efficacy+And+Safety+Of+Oral+Pf-06651600+And+Pf-06700841+As+Induction+And+Open+Label+Extension+Treatment+In+Subjects+With+Moderate+To+Severe+Crohn%E2%80%99s+Disease] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To obtain contact information for a study center near you, click here.",null,"Yes","No",{"$nulls":17},"2017-003359-43|PIZZICATO","EudraCT Number|Alias Study Number","Proportion of subjects achieving clinically meaningful endoscopic improvement (reduction of more than or equal to 3 points from baseline in Simplified Endoscopic Activity Score for Crohn's Disease (SES-CD) at Week 12","12 weeks",null,"Number of participants with potentially clinically important serious infections findings|Mean change from baseline in SES-CD score at Week 12.|Proportion of subjects achieving SES-CD 25 and SES-CD 50 at Week 12.|Proportion of subjects achieving endoscopic remission (SES-CD less than or equal to 2) at Week 12.|Proportion of subjects achieving mucosal healing at Week 12.|Number of subjects with adverse events|Number of subjects with serious adverse events|Number of subjects with electrocardiogram findings of potential clinical importance.|Number of subjects withdrawal due to adverse events|Number of subjects with vital signs findings of potential clinical importance.|Number of subjects with laboratory tests findings of potential clinical importance.|Proportion of subjects achieving SES CD 25 and SES CD 50 at Week 64 among subjects who achieved SES CD 25 and SES CD 50 at week 12 respectively.|Proportion of subjects achieving clinically meaningful endoscopic improvement (CMEI response) at week 64 among subjects who achieved CMEI response at Week 12.","64 weeks|Baseline, week 12|Number of subjects achieving SES-CD 25 and SES-CD 50 at Week 12.|Number of subjects achieving endoscopic remission (SES-CD less than or equal to 2) at Week 12.|Number of subjects achieving mucosal healing at Week 12.|Number of participants with reported adverse events|Number of participants with reported serious adverse events|Number of participants with potentially clinically important electrocardiogram findings.|Number of subjects withdrawal due to adverse events.|Number of participants with potentially clinically important vital signs findings.|Number of participants with potentially clinically important laboratory findings.|Number of subjects achieving SES-CD 25 and SES-CD 50 at Week 64 among subjects who achieved SES CD 25 and SES CD 50 at week 12|Number of subject achieving clinically meaningful endoscopic improvement (CMEI response) at week 64 among subjects who achieved CMEI response at week 12.","Baseline, week 12|Week 12|Baseline up to 64 weeks|Baseline u to 64 weeks|week 64","ClinicalTrials.gov_Inquiries@pfizer.com","Pfizer CT.gov Call Center","1-800-718-1021","Subiaco, Western|Ballarat, Victoria, Australia, 3350|Tbilisi, Georgia, 0141 David Tatishvili Medical CenterTbilisi, Georgia, 0186 Korea, Republic Of, Korea Kyungpook National University HospitalDaegu, Korea, Korea, Republic Of, 41944 Korea, Republic Of Severance Hospital, Yonsei University Health SystemSeoul, Korea, Republic Of, 03722|Kielce, Poland, 25-355 Endoskopia Sp. Z O. O.Sopot, Poland, 81-756 Ez-Med Sp. Z O.O. Sp.K.Swidnica, Poland, 58-100 Centrum Diagnostyczno-Lecznicze Barska Sp. Z O. O.Wloclawek, Poland, 87-800 Centrum Gastrologiczno HepatologiczneWroclaw, Poland, 50-555 LexmedicaWroclaw, Poland, 53-114 Russian Federation Federal State Budgetary Scientific Institution \"Scientific Research Institute Of Physiology AndNovosibirsk, Russian Federation, 630117 Clinic At Fsbei He \"Omsk State Medical University\" Moh RfOmsk, Russian Federation, 644050 Llc \"New Clinic\"Pyatigorsk, Russian Federation, 357500 Llc \"Riat\"Saint-Petersburg, Russian Federation, 195220 Saint-Petersburg State Budgetary Healthcare Institution \"City Hospital #26\"Saint-Petersburg, Russian Federation, 196247 Private Institution Educational Organization Of Higher EducationSamara, Russian Federation, 443011 Non-State Healthcare Institution 'Railway Clinical Hospital At Samara Station Of Open Joint StockSamara, Russian Federation, 443029 Saint-Petersburg State Budgetary Healthcare Institution \"City Clinical Hospital Of The RighteousSt. Petersburg, Russian Federation, 197706|Santander, Cantabria, Spain, 39008|Madrid, Spain, 28034 Hospital Universitario Virgen Del RocioSevilla, Spain, 41013|Ankara, Turkey, 06230 Hacettepe Universitesi Tip FakultesiAnkara, Turkey, 06230 Bezmialem Vakif Universitesi Tip Fakultesi HastanesiIstanbul, Turkey, 34093 Erciyes Universitesi Tip FakultesiKayseri, Turkey, 38039 Mersin Universitesi Tip Fakultesi Hastanesi, Ic HastaliklariMersin, Turkey, 33110 Mersin Universitesi Tip Fakultesi HastanesiMersin, Turkey, 33110 Karadeniz Teknik Universitesi Tip Fakultesi, Ic HastaliklariTrabzon, Turkey, 61080 Karadeniz Teknik Universitesi Tip FakultesiTrabzon, Turkey, 61080|Dothan, Alabama, United States, 36301 Gut P.C., Dba Digestive Health Specialists Of The SoutheastDothan, Alabama, United States, 36305|Beverly Hills, California, United States, 90210 Long Beach Clinical Trial Services, Inc.Long Beach, California, United States, 90806 Entertainment Medical GroupLos Angeles, California, United States, 90036 Gastrointestinal Biosciences Clinical Trials, LlcLos Angeles, California, United States, 90067 Alliance Clinical Research, LlcPoway, California, United States, 92064|Clearwater, Florida, United States, 33756-3839 West Coast Endoscopy CenterClearwater, Florida, United States, 33756 Gastro Florida (Regulatory & Administrative Duties)Clearwater, Florida, United States, 33762 Millenia Surgery CenterOrlando, Florida, United States, 32811 Hmd Research LlcOrlando, Florida, United States, 32819 Orlando Gastroenterology, PaOrlando, Florida, United States, 32835|Houma, Louisiana, United States, 70360 Gulf Coast Surgical CenterHouma, Louisiana, United States, 70360 The Hearing Center (Audiology)Houma, Louisiana, United States, 70360|Chevy Chase, Maryland, United States, 20815 Mgg Group Co., Inc., Chevy Chase Clinical ResearchChevy Chase, Maryland, United States, 20815|Worcester, Massachusetts, United States, 01655 University Of Massachusetts Medical SchoolWorcester, Massachusetts, United States, 01655|Chesterfield, Michigan, United States, 48047 Eastside Endoscopy CenterMacomb, Michigan, United States, 48044|New York, New York, United States, 10021 New York Presbyterian Hospital - Weill Cornell Medical College (Colonoscopy)New York, New York, United States, 10065 New York Presbyterian Hospital - Weill Cornell Medical College Investigational PharmacyNew York, New York, United States, 10065 Weill Cornell Medical College - New York Presbyterian Hospital (Endoscopy Suite)New York, New York, United States, 10065 Weill Cornell Medical College - New York Presbyterian HospitalNew York, New York, United States, 10065 Digiovanna Institute For Medical Education & ResearchNorth Massapequa, New York, United States, 11758-1802|Chapel Hill, North Carolina, United States, 27514 Unc HospitalsChapel Hill, North Carolina, United States, 27514 Unc Hospitals Endoscopy Center At Meadowmont (Endoscopy Only)Chapel Hill, North Carolina, United States, 27517 University Of North Carolina At Chapel Hill (Administration)Chapel Hill, North Carolina, United States, 27599 University Of North Carolina At Chapel Hill (Study Visits)Chapel Hill, North Carolina, United States, 27599 Gastroenterology Associates Of The Piedmont, PaWinston-Salem, North Carolina, United States, 27103 Pmg Research Of Winston-Salem, LlcWinston-Salem, North Carolina, United States, 27103|Kingsport, Tennessee, United States, 37660 Holston Medical GroupKingsport, Tennessee, United States, 37660 Holston Valley Surgery Center (Testing Only)Kingsport, Tennessee, United States, 37660|Arlington, Texas, United States, 76012 Envision Imaging (Cxr)Arlington, Texas, United States, 76012 Texas Clinical Research Institiute, LlcArlington, Texas, United States, 76012 Hermann Drive Surgical HospitalHouston, Texas, United States, 77004 Pearland Surgery CenterHouston, Texas, United States, 77047 Gulf Coast Research Group, LlcHouston, Texas, United States, 77098 Lonestar Endoscopy, LlpSouthlake, Texas, United States, 76092 Texas Digestive Disease ConsultantsSouthlake, Texas, United States, 76092|Fairfax, Virginia, United States, 22031","Alabama|California|Florida|Louisiana|Maryland|Massachusetts|Michigan|New York|North Carolina|Tennessee|Texas|Virginia","Australia|Georgia|Poland|Spain|Turkey|United States","Saint John Of God Subiaco Hospital|Victoria Ballarat Base Hospital|The First University Clinic Of Tsmu|Etg Kielce|Cantabria Hospital Universitario Marques De Valdecilla|Hospital Universitario Ramon Y Cajal|Hacettepe Universitesi Tip Fakultesi, Ic Hastaliklari Anabilim|Dothan Surgery Center (Colonoscopy And Tissue Biopsy Location)|Brighton Surgical Center|Gastro Florida|Cronola, Llc|Chevy Chase Endoscopy Center|Umass Memorial Medical Center|Clinical Research Institute Of Michigan, Llc|Weill Cornell Medical College (Clinical Site)|Unc Hospitals (Study Visits)|Holston Medical Group (Drug Shipment Only)|Cross Timbers Surgery Center L.P. (Colonoscopy)|Verity Research, Inc.",{"$nulls":3},"Pfizer CT.gov Call Center","2018-07-02","2020-05-25T16:36:02.819","2020-05-26T17:10:42.972","NCT03395184"]
["5ecbf3f3fe30261b1a048209","NCT03395184","2018-07-30","Pfizer","PFE","Recruiting","Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PFâ€‘06700841 In Subjects With Moderate To Severe Crohn's Disease","Brepocitinib|Pf-06651600","JAK1 Inhibitor|TYK2 Inhibitor|JAK1 Inhibitor|JAK3 Inhibitor","Yes","['Brepocitinib', 'Pf-06651600']","Yes","['TYK2 Inhibitor', 'JAK3 Inhibitor']","Phase 2",2,250,"Anticipated","2018-02-02","2020-02-04","DAS","Disease Activity Score",{"$nulls":3},"The objectives of this study are to evaluate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-06651600 (200 mg for 8 weeks followed by 50 mg for 4 weeks) dosed once daily and PF-06700841 (60 mg for 12 weeks) dosed once daily during an induction period of 12 weeks, followed by an open label extension period at doses of 50 mg and 30 mg of PF 06651600 and PF 06700841, respectively, for 52 weeks.",null,"A PHASE 2A, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ORAL PF-06651600 AND PF-06700841 AS INDUCTION AND OPEN LABEL EXTENSION TREATMENT IN SUBJECTS WITH MODERATE TO SEVERE CROHN'S DISEASE","B7981007","Crohn's Disease","Crohn Disease","Gastrointestinal Diseases","Gastrointestinal","Experimental","PF-06700841 or placebo|PF-06651600 or placebo",null,"Drug","Placebo PF-06700841|PF-06700841|Placebo PF-06651600|PF-06651600","12 weeks, followed by PF-06700841, 30 mg QD for 52 weeks.|60 mg QD for 12 weeks followed by 30 mg QD for up to 52 weeks|12 weeks, followed by PF-06651600, 50 mg QD for 52 weeks|200 mg QD for 8 weeks, followed by 50 mg QD up to 56 weeks",null,"PF-06700841 or placebo|PF-06651600 or placebo","\n\n 1. Male and/or female subjects 18 years to 75 years of age\n 2. Documented diagnosis of ileal, ileocolonic, or colonic CD with a minimum disease duration of 3 months, as determined by endoscopic and histopathology assessment.\n 3. Endoscopic confirmation of active disease with total SES CD total score of at least 7. For isolated ileal disease, SES CD total score should be at least 4.\n 4. An average daily liquid/soft stool frequency (SF) greater than or equal to 2.5 or daily abdominal pain (AP) greater than or equal to 2.0.\n 5. Must have inadequate response to, loss of response to, or intolerance to at least one conventional therapy for CD:â€¢Steroids; Immunosuppressants (azathioprine [AZA], 6 MP, or methotrexate [MTX]); Anti TNF inhibitors (infliximab, adalimumab,certolizumab); Anti integrin inhibitors (eg, vedolizumab); Anti IL 12/23 inhibitor (ustekinumab).\n    \n    \n 6. Subjects currently receiving the following treatment for CD are eligible providing they have been on stable doses as described below: * Oral corticosteroids (prednisone or equivalent up to 25 mg/day; budesonide up to 9 mg/day). Stable dose for at least 2 weeks prior to baseline. If oral corticosteroids have been recently discontinued, they must have been stopped at least 2 weeks prior to baseline. Decreases in steroid use due to AEs are allowed.\n     * Oral 5 ASA or sulfasalazine are allowed providing that the dose is stable for at least 4 weeks prior to baseline.\n     * Crohn's disease related antibiotics are allowed providing that the dose is stable for at least 4 weeks prior to baseline. If antibiotics are stopped prior to baseline, they must be discontinued at least 4 days prior to baseline.\n    \n    \n\n","\n\n 1.  Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, diverticular disease, ulcerative colitis (UC), or clinical findings suggestive of UC.\n 2.  Presence of active (draining) fistulae or intra abdominal or perineal abscesses.\n 3.  Strictures with obstructive symptoms.\n 4.  Short bowel syndrome.\n 5.  History of bowel perforation requiring surgical intervention within the past 12 months.\n 6.  Previous bowel surgery resulting in an existing stoma. Subjects who have a j pouch are excluded, as a j pouch can result in a stoma.\n 7.  History of bowel surgery within 6 months prior to baseline.\n 8.  Subjects displaying clinical signs of fulminant colitis or toxic megacolon.\n 9.  Subjects with primary sclerosing cholangitis.\n 10. Subjects with evidence of colonic adenomas, dysplasia or neoplasia.\n 11. Abnormal findings on the chest x ray film such as presence of tuberculosis (TB), general infections, heart failure, or malignancy.\n 12. Any history of either untreated or inadequately treated latent or active TB infection, current treatment for active or latent TB infection or evidence of currently active TB by chest x ray, residing with or frequent close contact with individual(s) with active TB.\n 13. Subjects receiving the following therapies within the time period described below or expected to receive any of these therapies during the study period: 1.  >9 mg/day of oral budesonide or >25 mg/day of prednisone or equivalent oral systemic corticosteroid dose within 2 weeks prior to baseline.\n      2.  IV, IM (parenteral), or topical (rectal) treatment of 5 ASA or corticosteroid enemas/suppositories within 2 weeks prior to baseline.\n      3.  Azathioprine, 6 mercaptopurine, or methotrexate within 2 weeks prior to baseline.\n      4.  Anti TNF inhibitors (or biosimilars thereof) as described below: * Infliximab within 8 weeks prior to baseline;\n           * Adalimumab within 8 weeks prior to baseline;\n           * Certolizumab within 8 weeks prior to baseline;\n          \n          \n      5.  Anti integrin inhibitors (eg, vedolizumab) within 8 weeks prior to baseline.\n      6.  Ustekinumab within 8 weeks prior to baseline.\n      7.  Interferon therapy within 8 weeks prior to baseline.\n      8.  Subjects with prior treatment with lymphocyte depleting agents/therapies within 1 year prior to baseline (eg, CamPath[alemtuzumab], alkylating agents [eg, cyclophosphamide or chlorambucil], total lymphoid irradiation, etc).\n      9.  Subjects who have received rituximab or other selective B lymphocyte depleting agents within 1 year prior to baseline.\n      10. Subjects previously receiving leukocyte apheresis, including selective lymphocyte, monocyte, or granulocyte apheresis, or plasma exchange within 6 months prior to baseline.\n      11. Other marketed immunosuppressants or biologics with immunomodulatory properties within 3 months prior to baseline.\n      12. Subjects who have received other JAK inhibitors within 3 months prior to baseline.\n      13. Subjects who have not responded to or have been intolerant of other JAK inhibitors.\n      14. Other investigational procedures(s) or product(s), such as immunosuppressants used in transplantation (eg, mycophenolate mofetil, cyclosporine, rapamycin, or tacrolimus) or live (attenuated) vaccine within 30 days prior to baseline.","TNF","tumor necrosis factor","Protein","Lung, Breast, Ovary","Actual","2018-01-10","Actual","Anticipated","2021-02-18","Anticipated","2018-07-01","2017-12-05","2018-01-03","2018-07-27","Yes",null,"Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years","75 Years","All",null,"No","Yes\nInformation relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests",null,"URL: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7981007&StudyName=A+Phase+2a%2C+Double-blind%2C+Randomized%2C+Placebo-controlled%2C+Parallel+Group+Study+To+Evaluate+The+Efficacy+And+Safety+Of+Oral+Pf-06651600+And+Pf-06700841+As+Induction+And+Open+Label+Extension+Treatment+In+Subjects+With+Moderate+To+Severe+Crohn%E2%80%99s+Disease [https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7981007&StudyName=A+Phase+2a%2C+Double-blind%2C+Randomized%2C+Placebo-controlled%2C+Parallel+Group+Study+To+Evaluate+The+Efficacy+And+Safety+Of+Oral+Pf-06651600+And+Pf-06700841+As+Induction+And+Open+Label+Extension+Treatment+In+Subjects+With+Moderate+To+Severe+Crohn%E2%80%99s+Disease] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To obtain contact information for a study center near you, click here.",null,"Yes","No",{"$nulls":17},"2017-003359-43|PIZZICATO","EudraCT Number|Alias Study Number","Proportion of subjects achieving clinically meaningful endoscopic improvement (reduction of more than or equal to 3 points from baseline in Simplified Endoscopic Activity Score for Crohn's Disease (SES-CD) at Week 12","12 weeks",null,"Number of participants with potentially clinically important serious infections findings|Mean change from baseline in SES-CD score at Week 12.|Proportion of subjects achieving SES-CD 25 and SES-CD 50 at Week 12.|Proportion of subjects achieving endoscopic remission (SES-CD less than or equal to 2) at Week 12.|Proportion of subjects achieving mucosal healing at Week 12.|Number of subjects with adverse events|Number of subjects with serious adverse events|Number of subjects with electrocardiogram findings of potential clinical importance.|Number of subjects withdrawal due to adverse events|Number of subjects with vital signs findings of potential clinical importance.|Number of subjects with laboratory tests findings of potential clinical importance.|Proportion of subjects achieving SES CD 25 and SES CD 50 at Week 64 among subjects who achieved SES CD 25 and SES CD 50 at week 12 respectively.|Proportion of subjects achieving clinically meaningful endoscopic improvement (CMEI response) at week 64 among subjects who achieved CMEI response at Week 12.","64 weeks|Baseline, week 12|Number of subjects achieving SES-CD 25 and SES-CD 50 at Week 12.|Number of subjects achieving endoscopic remission (SES-CD less than or equal to 2) at Week 12.|Number of subjects achieving mucosal healing at Week 12.|Number of participants with reported adverse events|Number of participants with reported serious adverse events|Number of participants with potentially clinically important electrocardiogram findings.|Number of subjects withdrawal due to adverse events.|Number of participants with potentially clinically important vital signs findings.|Number of participants with potentially clinically important laboratory findings.|Number of subjects achieving SES-CD 25 and SES-CD 50 at Week 64 among subjects who achieved SES CD 25 and SES CD 50 at week 12|Number of subject achieving clinically meaningful endoscopic improvement (CMEI response) at week 64 among subjects who achieved CMEI response at week 12.","Baseline, week 12|Week 12|Baseline up to 64 weeks|Baseline u to 64 weeks|week 64","ClinicalTrials.gov_Inquiries@pfizer.com","Pfizer CT.gov Call Center","1-800-718-1021","Concord, New South Wales, Australia, 2139|Subiaco, Western|Ballarat, Victoria, Australia, 3350|LiÃ¨ge, Belgium, 4000|Tbilisi, Georgia, 0141 David Tatishvili Medical CenterTbilisi, Georgia, 0186|Budapest, Hungary, 1088 Szent Janos Korhaz Es Eszak-Budai Egyesitett KorhazakBudapest, Hungary, 1125 Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz, Endoszkopos LaboratoriumGyula, Hungary, 5700 Clinfan Szolgaltato Kft.Szekszard, Hungary, 7100 Korea, Republic Of, Korea Kyungpook National University HospitalDaegu, Korea, Korea, Republic Of, 41944 Korea, Republic Of Kangbuk Samsung HospitalSeoul, Korea, Republic Of, 03181 Severance Hospital, Yonsei University Health SystemSeoul, Korea, Republic Of, 03722 The Catholic University Of Korea, Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591|Kielce, Poland, 25-355 Endoskopia Sp. Z O. O.Sopot, Poland, 81-756 Ez-Med Sp. Z O.O. Sp.K.Swidnica, Poland, 58-100 Gastromed Kopon, Zmudzinski I Wspolnicy Sp.J.Torun, Poland, 87-100 Centrum Diagnostyczno-Lecznicze Barska Sp. Z O. O.Wloclawek, Poland, 87-800 Centrum Gastrologiczno HepatologiczneWroclaw, Poland, 50-555 LexmedicaWroclaw, Poland, 53-114 Russian Federation Sechenov University On The Base Of Institute Of Translational Medicine And BiotechnologyMoscow, Russian Federation, 119435 Limited Liability Company \"Medical Center Sibnovomed\"Novosibirsk, Russian Federation, 630005 Federal State Budgetary Scientific Institution \"Scientific Research Institute Of Physiology AndNovosibirsk, Russian Federation, 630117 Clinic At Fsbei He \"Omsk State Medical University\" Moh RfOmsk, Russian Federation, 644050 Llc \"New Clinic\"Pyatigorsk, Russian Federation, 357500 Llc \"Riat\"Saint-Petersburg, Russian Federation, 195220 Saint-Petersburg State Budgetary Healthcare Institution \"City Hospital #26\"Saint-Petersburg, Russian Federation, 196247 Private Institution Educational Organization Of Higher EducationSamara, Russian Federation, 443011 Non-State Healthcare Institution 'Railway Clinical Hospital At Samara Station Of Open Joint StockSamara, Russian Federation, 443029 Saint-Petersburg State Budgetary Healthcare Institution \"City Clinical Hospital Of The RighteousSt. Petersburg, Russian Federation, 197706|Brezno, Slovakia, 97701 Km Management Spol. S.R.O.Nitra, Slovakia, 949 01 Accout Center S.R.O. Gastroenterologicka AmbulanciaSahy, Slovakia, 936 01 Endomed, S.R.O.Vranov Nad Toplou, Slovakia, 093 01|Santander, Cantabria, Spain, 39008|Granada, Spain, 18014 Hospital Universitario Ramon Y CajalMadrid, Spain, 28034 Hospital Universitario Virgen Del RocioSevilla, Spain, 41013 Hospital Universitari I Politecnic La FeValencia, Spain, 46026|Ankara, Turkey, 06230 Hacettepe Universitesi Tip FakultesiAnkara, Turkey, 06230 Bezmialem Vakif Universitesi Tip Fakultesi HastanesiIstanbul, Turkey, 34093 Erciyes Universitesi Tip FakultesiKayseri, Turkey, 38039 Mersin Universitesi Tip Fakultesi Hastanesi, Ic HastaliklariMersin, Turkey, 33110 Mersin Universitesi Tip Fakultesi HastanesiMersin, Turkey, 33110 Karadeniz Teknik Universitesi Tip Fakultesi, Ic HastaliklariTrabzon, Turkey, 61080 Karadeniz Teknik Universitesi Tip FakultesiTrabzon, Turkey, 61080|Chernivtsi, Ukraine, 58001 Private Enterprise Of Private Manufacturing Company \"Acinus\", Medical And Diagnostic CenterKropyvnytskyi, Ukraine, 25006 Kyiv Municipal Clinical Hospital #18, Proctology DepartmentKyiv, Ukraine, 01030 Lviv Clinical Hospital On Railway Transport Of Health Care Center Branch Of Pjsc Ukrainian RailwayLviv, Ukraine, 79007 Private Small-Scale Enterprise Medical Center \"Pulse\"Vinnytsia, Ukraine, 21001|Dothan, Alabama, United States, 36301 Gut P.C., Dba Digestive Health Specialists Of The SoutheastDothan, Alabama, United States, 36305|Beverly Hills, California, United States, 90210 Long Beach Clinical Trial Services, Inc.Long Beach, California, United States, 90806 Entertainment Medical GroupLos Angeles, California, United States, 90036 Gastrointestinal Biosciences Clinical Trials, LlcLos Angeles, California, United States, 90067 Alliance Clinical Research, LlcPoway, California, United States, 92064|Clearwater, Florida, United States, 33756-3839 West Coast Endoscopy CenterClearwater, Florida, United States, 33756 Gastro Florida (Regulatory & Administrative Duties)Clearwater, Florida, United States, 33762 Millenia Surgery CenterOrlando, Florida, United States, 32811 Hmd Research LlcOrlando, Florida, United States, 32819 Orlando Gastroenterology, PaOrlando, Florida, United States, 32835|Houma, Louisiana, United States, 70360 Gulf Coast Surgical CenterHouma, Louisiana, United States, 70360 The Hearing Center (Audiology)Houma, Louisiana, United States, 70360|Chevy Chase, Maryland, United States, 20815 Mgg Group Co., Inc., Chevy Chase Clinical ResearchChevy Chase, Maryland, United States, 20815|Boston, Massachusetts, United States, 02115 Brigham And Women'S HospitalBoston, Massachusetts, United States, 02115 Mass Eye And Ear, LongwoodBoston, Massachusetts, United States, 02115 Brigham And Women'S Hospital (Endoscopy)Chestnut Hill, Massachusetts, United States, 02467 Umass Memorial Medical CenterWorcester, Massachusetts, United States, 01655 University Of Massachusetts Medical SchoolWorcester, Massachusetts, United States, 01655|Chesterfield, Michigan, United States, 48047 Eastside Endoscopy CenterMacomb, Michigan, United States, 48044|New York, New York, United States, 10021 New York Presbyterian Hospital - Weill Cornell Medical College (Colonoscopy)New York, New York, United States, 10065 New York Presbyterian Hospital - Weill Cornell Medical College Investigational PharmacyNew York, New York, United States, 10065 Weill Cornell Medical College - New York Presbyterian Hospital (Endoscopy Suite)New York, New York, United States, 10065 Weill Cornell Medical College - New York Presbyterian HospitalNew York, New York, United States, 10065 Digiovanna Institute For Medical Education & ResearchNorth Massapequa, New York, United States, 11758-1802|Chapel Hill, North Carolina, United States, 27514 Unc HospitalsChapel Hill, North Carolina, United States, 27514 Unc Hospitals Endoscopy Center At Meadowmont (Endoscopy Only)Chapel Hill, North Carolina, United States, 27517 University Of North Carolina At Chapel Hill (Administration)Chapel Hill, North Carolina, United States, 27599 University Of North Carolina At Chapel Hill (Study Visits)Chapel Hill, North Carolina, United States, 27599 Gastroenterology Associates Of The Piedmont, PaWinston-Salem, North Carolina, United States, 27103 Pmg Research Of Winston-Salem, LlcWinston-Salem, North Carolina, United States, 27103|Kingsport, Tennessee, United States, 37660 Holston Medical GroupKingsport, Tennessee, United States, 37660 Holston Valley Surgery Center (Testing Only)Kingsport, Tennessee, United States, 37660|Arlington, Texas, United States, 76012 Envision Imaging (Cxr)Arlington, Texas, United States, 76012 Texas Clinical Research Institiute, LlcArlington, Texas, United States, 76012 Hermann Drive Surgical HospitalHouston, Texas, United States, 77004 Pearland Surgery CenterHouston, Texas, United States, 77047 Gulf Coast Research Group, LlcHouston, Texas, United States, 77098 Lonestar Endoscopy, LlpSouthlake, Texas, United States, 76092 Texas Digestive Disease ConsultantsSouthlake, Texas, United States, 76092|Fairfax, Virginia, United States, 22031","Alabama|California|Florida|Louisiana|Maryland|Massachusetts|Michigan|New York|North Carolina|Tennessee|Texas|Virginia","Australia|Belgium|Georgia|Hungary|Poland|Slovakia|Spain|Turkey|Ukraine|United States","New South Wales Concord Repatriation General Hospital|Saint John Of God Subiaco Hospital|Victoria Ballarat Base Hospital|Chc - Saint-Joseph|The First University Clinic Of Tsmu|Semmelweis Egyetem, Ii. Belgyogyaszati Klinika|Etg Kielce|Breznianske Centrum Gastroenterologie S.R.O.|Cantabria Hospital Universitario Marques De Valdecilla|Hospital Universitario Virgen De Las Nieves De Granada|Hacettepe Universitesi Tip Fakultesi, Ic Hastaliklari Anabilim|Regional Municipal Institution \"Chernivtsi Regional Clinical Hospital\", Gastroenterology Department,|Dothan Surgery Center (Colonoscopy And Tissue Biopsy Location)|Brighton Surgical Center|Gastro Florida|Cronola, Llc|Chevy Chase Endoscopy Center|Brigham And Women's Hospital (Drug Shipment Only)|Clinical Research Institute Of Michigan, Llc|Weill Cornell Medical College (Clinical Site)|Unc Hospitals (Study Visits)|Holston Medical Group (Drug Shipment Only)|Cross Timbers Surgery Center L.P. (Colonoscopy)|Verity Research, Inc.",{"$nulls":3},"Pfizer CT.gov Call Center","2018-07-27","2020-05-25T16:36:03.100","2020-05-26T17:10:42.972","NCT03395184"]
["5ecbf3f2307e3d1b1f8d9c99","NCT03395184","2018-08-14","Pfizer","PFE","Recruiting","Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PFâ€‘06700841 In Subjects With Moderate To Severe Crohn's Disease","Brepocitinib|Pf-06651600","JAK1 Inhibitor|TYK2 Inhibitor|JAK1 Inhibitor|JAK3 Inhibitor","Yes","['Brepocitinib', 'Pf-06651600']","Yes","['TYK2 Inhibitor', 'JAK3 Inhibitor']","Phase 2",2,250,"Anticipated","2018-02-02","2020-02-04","DAS","Disease Activity Score",{"$nulls":3},"The objectives of this study are to evaluate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-06651600 (200 mg for 8 weeks followed by 50 mg for 4 weeks) dosed once daily and PF-06700841 (60 mg for 12 weeks) dosed once daily during an induction period of 12 weeks, followed by an open label extension period at doses of 50 mg and 30 mg of PF 06651600 and PF 06700841, respectively, for 52 weeks.",null,"A PHASE 2A, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ORAL PF-06651600 AND PF-06700841 AS INDUCTION AND OPEN LABEL EXTENSION TREATMENT IN SUBJECTS WITH MODERATE TO SEVERE CROHN'S DISEASE","B7981007","Crohn's Disease","Crohn Disease","Gastrointestinal Diseases","Gastrointestinal","Experimental","PF-06700841 or placebo|PF-06651600 or placebo",null,"Drug","Placebo PF-06700841|PF-06700841|Placebo PF-06651600|PF-06651600","12 weeks, followed by PF-06700841, 30 mg QD for 52 weeks.|60 mg QD for 12 weeks followed by 30 mg QD for up to 52 weeks|12 weeks, followed by PF-06651600, 50 mg QD for 52 weeks|200 mg QD for 8 weeks, followed by 50 mg QD up to 56 weeks",null,"PF-06700841 or placebo|PF-06651600 or placebo","\n\n 1. Male and/or female subjects 18 years to 75 years of age\n 2. Documented diagnosis of ileal, ileocolonic, or colonic CD with a minimum disease duration of 3 months, as determined by endoscopic and histopathology assessment.\n 3. Endoscopic confirmation of active disease with total SES CD total score of at least 7. For isolated ileal disease, SES CD total score should be at least 4.\n 4. An average daily liquid/soft stool frequency (SF) greater than or equal to 2.5 or daily abdominal pain (AP) greater than or equal to 2.0.\n 5. Must have inadequate response to, loss of response to, or intolerance to at least one conventional therapy for CD:â€¢Steroids; Immunosuppressants (azathioprine [AZA], 6 MP, or methotrexate [MTX]); Anti TNF inhibitors (infliximab, adalimumab,certolizumab); Anti integrin inhibitors (eg, vedolizumab); Anti IL 12/23 inhibitor (ustekinumab).\n    \n    \n 6. Subjects currently receiving the following treatment for CD are eligible providing they have been on stable doses as described below: * Oral corticosteroids (prednisone or equivalent up to 25 mg/day; budesonide up to 9 mg/day). Stable dose for at least 2 weeks prior to baseline. If oral corticosteroids have been recently discontinued, they must have been stopped at least 2 weeks prior to baseline. Decreases in steroid use due to AEs are allowed.\n     * Oral 5 ASA or sulfasalazine are allowed providing that the dose is stable for at least 4 weeks prior to baseline.\n     * Crohn's disease related antibiotics are allowed providing that the dose is stable for at least 4 weeks prior to baseline. If antibiotics are stopped prior to baseline, they must be discontinued at least 4 days prior to baseline.\n    \n    \n\n","\n\n 1.  Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, diverticular disease, ulcerative colitis (UC), or clinical findings suggestive of UC.\n 2.  Presence of active (draining) fistulae or intra abdominal or perineal abscesses.\n 3.  Strictures with obstructive symptoms.\n 4.  Short bowel syndrome.\n 5.  History of bowel perforation requiring surgical intervention within the past 12 months.\n 6.  Previous bowel surgery resulting in an existing stoma. Subjects who have a j pouch are excluded, as a j pouch can result in a stoma.\n 7.  History of bowel surgery within 6 months prior to baseline.\n 8.  Subjects displaying clinical signs of fulminant colitis or toxic megacolon.\n 9.  Subjects with primary sclerosing cholangitis.\n 10. Subjects with evidence of colonic adenomas, dysplasia or neoplasia.\n 11. Abnormal findings on the chest x ray film such as presence of tuberculosis (TB), general infections, heart failure, or malignancy.\n 12. Any history of either untreated or inadequately treated latent or active TB infection, current treatment for active or latent TB infection or evidence of currently active TB by chest x ray, residing with or frequent close contact with individual(s) with active TB.\n 13. Subjects receiving the following therapies within the time period described below or expected to receive any of these therapies during the study period: 1.  >9 mg/day of oral budesonide or >25 mg/day of prednisone or equivalent oral systemic corticosteroid dose within 2 weeks prior to baseline.\n      2.  IV, IM (parenteral), or topical (rectal) treatment of 5 ASA or corticosteroid enemas/suppositories within 2 weeks prior to baseline.\n      3.  Azathioprine, 6 mercaptopurine, or methotrexate within 2 weeks prior to baseline.\n      4.  Anti TNF inhibitors (or biosimilars thereof) as described below: * Infliximab within 8 weeks prior to baseline;\n           * Adalimumab within 8 weeks prior to baseline;\n           * Certolizumab within 8 weeks prior to baseline;\n          \n          \n      5.  Anti integrin inhibitors (eg, vedolizumab) within 8 weeks prior to baseline.\n      6.  Ustekinumab within 8 weeks prior to baseline.\n      7.  Interferon therapy within 8 weeks prior to baseline.\n      8.  Subjects with prior treatment with lymphocyte depleting agents/therapies within 1 year prior to baseline (eg, CamPath[alemtuzumab], alkylating agents [eg, cyclophosphamide or chlorambucil], total lymphoid irradiation, etc).\n      9.  Subjects who have received rituximab or other selective B lymphocyte depleting agents within 1 year prior to baseline.\n      10. Subjects previously receiving leukocyte apheresis, including selective lymphocyte, monocyte, or granulocyte apheresis, or plasma exchange within 6 months prior to baseline.\n      11. Other marketed immunosuppressants or biologics with immunomodulatory properties within 3 months prior to baseline.\n      12. Subjects who have received other JAK inhibitors within 3 months prior to baseline.\n      13. Subjects who have not responded to or have been intolerant of other JAK inhibitors.\n      14. Other investigational procedures(s) or product(s), such as immunosuppressants used in transplantation (eg, mycophenolate mofetil, cyclosporine, rapamycin, or tacrolimus) or live (attenuated) vaccine within 30 days prior to baseline.","TNF","tumor necrosis factor","Protein","Lung, Breast, Ovary","Actual","2018-01-10","Actual","Anticipated","2021-02-18","Anticipated","2018-08-01","2017-12-05","2018-01-03","2018-08-13","Yes",null,"Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years","75 Years","All",null,"No","Yes\nInformation relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests",null,"URL: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7981007&StudyName=A+Phase+2a%2C+Double-blind%2C+Randomized%2C+Placebo-controlled%2C+Parallel+Group+Study+To+Evaluate+The+Efficacy+And+Safety+Of+Oral+Pf-06651600+And+Pf-06700841+As+Induction+And+Open+Label+Extension+Treatment+In+Subjects+With+Moderate+To+Severe+Crohn%E2%80%99s+Disease [https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7981007&StudyName=A+Phase+2a%2C+Double-blind%2C+Randomized%2C+Placebo-controlled%2C+Parallel+Group+Study+To+Evaluate+The+Efficacy+And+Safety+Of+Oral+Pf-06651600+And+Pf-06700841+As+Induction+And+Open+Label+Extension+Treatment+In+Subjects+With+Moderate+To+Severe+Crohn%E2%80%99s+Disease] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To obtain contact information for a study center near you, click here.",null,"Yes","No",{"$nulls":17},"2017-003359-43|PIZZICATO","EudraCT Number|Alias Study Number","Proportion of subjects achieving clinically meaningful endoscopic improvement (reduction of more than or equal to 3 points from baseline in Simplified Endoscopic Activity Score for Crohn's Disease (SES-CD) at Week 12","12 weeks",null,"Number of participants with potentially clinically important serious infections findings|Mean change from baseline in SES-CD score at Week 12.|Proportion of subjects achieving SES-CD 25 and SES-CD 50 at Week 12.|Proportion of subjects achieving endoscopic remission (SES-CD less than or equal to 2) at Week 12.|Proportion of subjects achieving mucosal healing at Week 12.|Number of subjects with adverse events|Number of subjects with serious adverse events|Number of subjects with electrocardiogram findings of potential clinical importance.|Number of subjects withdrawal due to adverse events|Number of subjects with vital signs findings of potential clinical importance.|Number of subjects with laboratory tests findings of potential clinical importance.|Proportion of subjects achieving SES CD 25 and SES CD 50 at Week 64 among subjects who achieved SES CD 25 and SES CD 50 at week 12 respectively.|Proportion of subjects achieving clinically meaningful endoscopic improvement (CMEI response) at week 64 among subjects who achieved CMEI response at Week 12.","64 weeks|Baseline, week 12|Number of subjects achieving SES-CD 25 and SES-CD 50 at Week 12.|Number of subjects achieving endoscopic remission (SES-CD less than or equal to 2) at Week 12.|Number of subjects achieving mucosal healing at Week 12.|Number of participants with reported adverse events|Number of participants with reported serious adverse events|Number of participants with potentially clinically important electrocardiogram findings.|Number of subjects withdrawal due to adverse events.|Number of participants with potentially clinically important vital signs findings.|Number of participants with potentially clinically important laboratory findings.|Number of subjects achieving SES-CD 25 and SES-CD 50 at Week 64 among subjects who achieved SES CD 25 and SES CD 50 at week 12|Number of subject achieving clinically meaningful endoscopic improvement (CMEI response) at week 64 among subjects who achieved CMEI response at week 12.","Baseline, week 12|Week 12|Baseline up to 64 weeks|Baseline u to 64 weeks|week 64","ClinicalTrials.gov_Inquiries@pfizer.com","Pfizer CT.gov Call Center","1-800-718-1021","Concord, New South Wales, Australia, 2139|Subiaco, Western|Ballarat, Victoria, Australia, 3350|Leuven, Belgium, 3000 Chc - Saint-JosephLiÃ¨ge, Belgium, 4000|Tbilisi, Georgia, 0141 David Tatishvili Medical CenterTbilisi, Georgia, 0186|Budapest, Hungary, 1088 Szent Janos Korhaz Es Eszak-Budai Egyesitett KorhazakBudapest, Hungary, 1125 Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz, Endoszkopos LaboratoriumGyula, Hungary, 5700 Clinfan Szolgaltato Kft.Szekszard, Hungary, 7100 Korea, Republic Of, Korea Kyungpook National University HospitalDaegu, Korea, Korea, Republic Of, 41944 Korea, Republic Of Kangbuk Samsung HospitalSeoul, Korea, Republic Of, 03181 Severance Hospital, Yonsei University Health SystemSeoul, Korea, Republic Of, 03722 The Catholic University Of Korea, Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591|Katowice, Poland, 40-659 Etg KielceKielce, Poland, 25-355 Indywidualna Specjalstyczna Praktyka Lekarska Maciej ZymlaKnurow, Poland, 44-190 Szpital W Knurowie Sp. Z O.O.Knurow, Poland, 44-190 Centrum Badan Klinicznych JciKrakow, Poland, 30-348 Marta Dagmara Banach Marta Banach Specjalistyczny Gabinet NeurologicznyKrakow, Poland, 30-539 Centrum Medyczne EvitaKrakow, Poland, 31-153 Szpital Specjalistyczny Im. Ludwika Rydygiera W Krakowie Sp. Z O.O.Krakow, Poland, 31-826 Ai Centrum Medyczne Sp. Z O.O. Sp.K.Poznan, Poland, 61-113 Endoskopia Sp. Z O. O.Sopot, Poland, 81-756 Szpital Sredzki Serca Jezusowego Sp. Z O.O.Sroda Wielkopolska, Poland, 63-000 Ez-Med Sp. Z O.O. Sp.K.Swidnica, Poland, 58-100 Gastromed Kopon, Zmudzinski I Wspolnicy Sp.J.Torun, Poland, 87-100 Centrum Zdrowia MdmWarszawa, Poland, 00-635 Centrum Diagnostyczno-Lecznicze Barska Sp. Z O. O.Wloclawek, Poland, 87-800 Centrum Gastrologiczno HepatologiczneWroclaw, Poland, 50-555 LexmedicaWroclaw, Poland, 53-114 Russian Federation Sechenov University On The Base Of Institute Of Translational Medicine And BiotechnologyMoscow, Russian Federation, 119435 Limited Liability Company \"Medical Center Sibnovomed\"Novosibirsk, Russian Federation, 630005 Federal State Budgetary Scientific Institution \"Scientific Research Institute Of Physiology AndNovosibirsk, Russian Federation, 630117 Clinic At Fsbei He \"Omsk State Medical University\" Moh RfOmsk, Russian Federation, 644050 Llc \"New Clinic\"Pyatigorsk, Russian Federation, 357500 Llc \"Riat\"Saint-Petersburg, Russian Federation, 195220 Saint-Petersburg State Budgetary Healthcare Institution \"City Hospital #26\"Saint-Petersburg, Russian Federation, 196247 Private Institution Educational Organization Of Higher EducationSamara, Russian Federation, 443011 Non-State Healthcare Institution 'Railway Clinical Hospital At Samara Station Of Open Joint StockSamara, Russian Federation, 443029 Saint-Petersburg State Budgetary Healthcare Institution \"City Clinical Hospital Of The RighteousSt. Petersburg, Russian Federation, 197706|Brezno, Slovakia, 97701 Km Management Spol. S.R.O.Nitra, Slovakia, 949 01 Accout Center S.R.O. Gastroenterologicka AmbulanciaSahy, Slovakia, 936 01 Endomed, S.R.O.Vranov Nad Toplou, Slovakia, 093 01|Santander, Cantabria, Spain, 39008|Granada, Spain, 18014 Hospital Universitario Ramon Y CajalMadrid, Spain, 28034 Hospital Universitario Virgen Del RocioSevilla, Spain, 41013 Hospital Universitari I Politecnic La FeValencia, Spain, 46026|Ankara, Turkey, 06230 Hacettepe Universitesi Tip FakultesiAnkara, Turkey, 06230 Bezmialem Vakif Universitesi Tip Fakultesi HastanesiIstanbul, Turkey, 34093 Erciyes Universitesi Tip FakultesiKayseri, Turkey, 38039 Mersin Universitesi Tip Fakultesi Hastanesi, Ic HastaliklariMersin, Turkey, 33110 Mersin Universitesi Tip Fakultesi HastanesiMersin, Turkey, 33110 Karadeniz Teknik Universitesi Tip Fakultesi, Ic HastaliklariTrabzon, Turkey, 61080 Karadeniz Teknik Universitesi Tip FakultesiTrabzon, Turkey, 61080|Chernivtsi, Ukraine, 58001 Private Enterprise Of Private Manufacturing Company \"Acinus\", Medical And Diagnostic CenterKropyvnytskyi, Ukraine, 25006 Kyiv Municipal Clinical Hospital #18, Proctology DepartmentKyiv, Ukraine, 01030 Lviv Clinical Hospital On Railway Transport Of Health Care Center Branch Of Pjsc Ukrainian RailwayLviv, Ukraine, 79007 Private Small-Scale Enterprise Medical Center \"Pulse\"Vinnytsia, Ukraine, 21001|Dothan, Alabama, United States, 36301 Gut P.C., Dba Digestive Health Specialists Of The SoutheastDothan, Alabama, United States, 36305|Beverly Hills, California, United States, 90210 Long Beach Clinical Trial Services, Inc.Long Beach, California, United States, 90806 Entertainment Medical GroupLos Angeles, California, United States, 90036 Gastrointestinal Biosciences Clinical Trials, LlcLos Angeles, California, United States, 90067 Alliance Clinical Research, LlcPoway, California, United States, 92064|Clearwater, Florida, United States, 33756-3839 West Coast Endoscopy CenterClearwater, Florida, United States, 33756 Gastro FloridaClearwater, Florida, United States, 33762 Millenia Surgery CenterOrlando, Florida, United States, 32811 Hmd Research LlcOrlando, Florida, United States, 32819 Orlando Gastroenterology, PaOrlando, Florida, United States, 32835|Houma, Louisiana, United States, 70360 Gulf Coast Surgical CenterHouma, Louisiana, United States, 70360 The Hearing Center (Audiology)Houma, Louisiana, United States, 70360|Chevy Chase, Maryland, United States, 20815 Mgg Group Co., Inc., Chevy Chase Clinical ResearchChevy Chase, Maryland, United States, 20815|Boston, Massachusetts, United States, 02115 Brigham And Women'S HospitalBoston, Massachusetts, United States, 02115 Mass Eye And Ear, LongwoodBoston, Massachusetts, United States, 02115 Brigham And Women'S Hospital (Endoscopy)Chestnut Hill, Massachusetts, United States, 02467 Umass Memorial Medical CenterWorcester, Massachusetts, United States, 01655 University Of Massachusetts Medical SchoolWorcester, Massachusetts, United States, 01655|Chesterfield, Michigan, United States, 48047 Eastside Endoscopy CenterMacomb, Michigan, United States, 48044|New York, New York, United States, 10021 New York Presbyterian Hospital - Weill Cornell Medical College (Colonoscopy)New York, New York, United States, 10065 New York Presbyterian Hospital - Weill Cornell Medical College Investigational PharmacyNew York, New York, United States, 10065 Weill Cornell Medical College - New York Presbyterian Hospital (Endoscopy Suite)New York, New York, United States, 10065 Weill Cornell Medical College - New York Presbyterian HospitalNew York, New York, United States, 10065 Digiovanna Institute For Medical Education & ResearchNorth Massapequa, New York, United States, 11758-1802|Chapel Hill, North Carolina, United States, 27514 Unc Hospitals Endoscopy Center At MeadowmontChapel Hill, North Carolina, United States, 27517 University Of North Carolina At Chapel HillChapel Hill, North Carolina, United States, 27599 Gastroenterology Associates Of The Piedmont, PaWinston-Salem, North Carolina, United States, 27103 Pmg Research Of Winston-Salem, LlcWinston-Salem, North Carolina, United States, 27103|Kingsport, Tennessee, United States, 37660 Holston Medical GroupKingsport, Tennessee, United States, 37660 Holston Valley Surgery Center (Testing Only)Kingsport, Tennessee, United States, 37660|Arlington, Texas, United States, 76012 Envision Imaging (Cxr)Arlington, Texas, United States, 76012 Texas Clinical Research Institiute, LlcArlington, Texas, United States, 76012 Hermann Drive Surgical HospitalHouston, Texas, United States, 77004 Pearland Surgery CenterHouston, Texas, United States, 77047 Gulf Coast Research Group, LlcHouston, Texas, United States, 77098 Lonestar Endoscopy, LlpSouthlake, Texas, United States, 76092 Texas Digestive Disease ConsultantsSouthlake, Texas, United States, 76092|Fairfax, Virginia, United States, 22031","Alabama|California|Florida|Louisiana|Maryland|Massachusetts|Michigan|New York|North Carolina|Tennessee|Texas|Virginia","Australia|Belgium|Georgia|Hungary|Poland|Slovakia|Spain|Turkey|Ukraine|United States","New South Wales Concord Repatriation General Hospital|Saint John Of God Subiaco Hospital|Victoria Ballarat Base Hospital|University Hospitals Leuven|The First University Clinic Of Tsmu|Semmelweis Egyetem, Ii. Belgyogyaszati Klinika|Niepubliczny Zaklad Opieki Zdrowotnej All-Medicus|Breznianske Centrum Gastroenterologie S.R.O.|Cantabria Hospital Universitario Marques De Valdecilla|Hospital Universitario Virgen De Las Nieves De Granada|Hacettepe Universitesi Tip Fakultesi, Ic Hastaliklari Anabilim|Regional Municipal Institution \"Chernivtsi Regional Clinical Hospital\", Gastroenterology Department,|Dothan Surgery Center (Colonoscopy And Tissue Biopsy Location)|Brighton Surgical Center|Gastro Florida|Cronola, Llc|Chevy Chase Endoscopy Center|Brigham And Women's Hospital (Drug Shipment Only)|Clinical Research Institute Of Michigan, Llc|Weill Cornell Medical College (Clinical Site)|Unc Hospitals|Holston Medical Group (Drug Shipment Only)|Cross Timbers Surgery Center L.P. (Colonoscopy)|Verity Research, Inc.",{"$nulls":3},"Pfizer CT.gov Call Center","2018-08-13","2020-05-25T16:36:02.818","2020-05-26T17:10:42.972","NCT03395184"]
["5ecbf3f3feab101b15530839","NCT03395184","2018-08-17","Pfizer","PFE","Recruiting","Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PFâ€‘06700841 In Subjects With Moderate To Severe Crohn's Disease","Brepocitinib|Pf-06651600","JAK1 Inhibitor|TYK2 Inhibitor|JAK1 Inhibitor|JAK3 Inhibitor","Yes","['Brepocitinib', 'Pf-06651600']","Yes","['TYK2 Inhibitor', 'JAK3 Inhibitor']","Phase 2",2,250,"Anticipated","2018-02-02","2020-02-04","DAS","Disease Activity Score",{"$nulls":3},"The objectives of this study are to evaluate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-06651600 (200 mg for 8 weeks followed by 50 mg for 4 weeks) dosed once daily and PF-06700841 (60 mg for 12 weeks) dosed once daily during an induction period of 12 weeks, followed by an open label extension period at doses of 50 mg and 30 mg of PF 06651600 and PF 06700841, respectively, for 52 weeks.",null,"A PHASE 2A, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ORAL PF-06651600 AND PF-06700841 AS INDUCTION AND OPEN LABEL EXTENSION TREATMENT IN SUBJECTS WITH MODERATE TO SEVERE CROHN'S DISEASE","B7981007","Crohn's Disease","Crohn Disease","Gastrointestinal Diseases","Gastrointestinal","Experimental","PF-06700841 or placebo|PF-06651600 or placebo",null,"Drug","Placebo PF-06700841|PF-06700841|Placebo PF-06651600|PF-06651600","12 weeks, followed by PF-06700841, 30 mg QD for 52 weeks.|60 mg QD for 12 weeks followed by 30 mg QD for up to 52 weeks|12 weeks, followed by PF-06651600, 50 mg QD for 52 weeks|200 mg QD for 8 weeks, followed by 50 mg QD up to 56 weeks",null,"PF-06700841 or placebo|PF-06651600 or placebo","\n\n 1. Male and/or female subjects 18 years to 75 years of age\n 2. Documented diagnosis of ileal, ileocolonic, or colonic CD with a minimum disease duration of 3 months, as determined by endoscopic and histopathology assessment.\n 3. Endoscopic confirmation of active disease with total SES CD total score of at least 7. For isolated ileal disease, SES CD total score should be at least 4.\n 4. An average daily liquid/soft stool frequency (SF) greater than or equal to 2.5 or daily abdominal pain (AP) greater than or equal to 2.0.\n 5. Must have inadequate response to, loss of response to, or intolerance to at least one conventional therapy for CD:â€¢Steroids; Immunosuppressants (azathioprine [AZA], 6 MP, or methotrexate [MTX]); Anti TNF inhibitors (infliximab, adalimumab,certolizumab); Anti integrin inhibitors (eg, vedolizumab); Anti IL 12/23 inhibitor (ustekinumab).\n    \n    \n 6. Subjects currently receiving the following treatment for CD are eligible providing they have been on stable doses as described below: * Oral corticosteroids (prednisone or equivalent up to 25 mg/day; budesonide up to 9 mg/day). Stable dose for at least 2 weeks prior to baseline. If oral corticosteroids have been recently discontinued, they must have been stopped at least 2 weeks prior to baseline. Decreases in steroid use due to AEs are allowed.\n     * Oral 5 ASA or sulfasalazine are allowed providing that the dose is stable for at least 4 weeks prior to baseline.\n     * Crohn's disease related antibiotics are allowed providing that the dose is stable for at least 4 weeks prior to baseline. If antibiotics are stopped prior to baseline, they must be discontinued at least 4 days prior to baseline.\n    \n    \n\n","\n\n 1.  Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, diverticular disease, ulcerative colitis (UC), or clinical findings suggestive of UC.\n 2.  Presence of active (draining) fistulae or intra abdominal or perineal abscesses.\n 3.  Strictures with obstructive symptoms.\n 4.  Short bowel syndrome.\n 5.  History of bowel perforation requiring surgical intervention within the past 12 months.\n 6.  Previous bowel surgery resulting in an existing stoma. Subjects who have a j pouch are excluded, as a j pouch can result in a stoma.\n 7.  History of bowel surgery within 6 months prior to baseline.\n 8.  Subjects displaying clinical signs of fulminant colitis or toxic megacolon.\n 9.  Subjects with primary sclerosing cholangitis.\n 10. Subjects with evidence of colonic adenomas, dysplasia or neoplasia.\n 11. Abnormal findings on the chest x ray film such as presence of tuberculosis (TB), general infections, heart failure, or malignancy.\n 12. Any history of either untreated or inadequately treated latent or active TB infection, current treatment for active or latent TB infection or evidence of currently active TB by chest x ray, residing with or frequent close contact with individual(s) with active TB.\n 13. Subjects receiving the following therapies within the time period described below or expected to receive any of these therapies during the study period: 1.  >9 mg/day of oral budesonide or >25 mg/day of prednisone or equivalent oral systemic corticosteroid dose within 2 weeks prior to baseline.\n      2.  IV, IM (parenteral), or topical (rectal) treatment of 5 ASA or corticosteroid enemas/suppositories within 2 weeks prior to baseline.\n      3.  Azathioprine, 6 mercaptopurine, or methotrexate within 2 weeks prior to baseline.\n      4.  Anti TNF inhibitors (or biosimilars thereof) as described below: * Infliximab within 8 weeks prior to baseline;\n           * Adalimumab within 8 weeks prior to baseline;\n           * Certolizumab within 8 weeks prior to baseline;\n          \n          \n      5.  Anti integrin inhibitors (eg, vedolizumab) within 8 weeks prior to baseline.\n      6.  Ustekinumab within 8 weeks prior to baseline.\n      7.  Interferon therapy within 8 weeks prior to baseline.\n      8.  Subjects with prior treatment with lymphocyte depleting agents/therapies within 1 year prior to baseline (eg, CamPath[alemtuzumab], alkylating agents [eg, cyclophosphamide or chlorambucil], total lymphoid irradiation, etc).\n      9.  Subjects who have received rituximab or other selective B lymphocyte depleting agents within 1 year prior to baseline.\n      10. Subjects previously receiving leukocyte apheresis, including selective lymphocyte, monocyte, or granulocyte apheresis, or plasma exchange within 6 months prior to baseline.\n      11. Other marketed immunosuppressants or biologics with immunomodulatory properties within 3 months prior to baseline.\n      12. Subjects who have received other JAK inhibitors within 3 months prior to baseline.\n      13. Subjects who have not responded to or have been intolerant of other JAK inhibitors.\n      14. Other investigational procedures(s) or product(s), such as immunosuppressants used in transplantation (eg, mycophenolate mofetil, cyclosporine, rapamycin, or tacrolimus) or live (attenuated) vaccine within 30 days prior to baseline.","TNF","tumor necrosis factor","Protein","Lung, Breast, Ovary","Actual","2018-01-10","Actual","Anticipated","2021-02-18","Anticipated","2018-08-01","2017-12-05","2018-01-03","2018-08-16","Yes",null,"Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years","75 Years","All",null,"No","Yes\nInformation relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests",null,"URL: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7981007&StudyName=A+Phase+2a%2C+Double-blind%2C+Randomized%2C+Placebo-controlled%2C+Parallel+Group+Study+To+Evaluate+The+Efficacy+And+Safety+Of+Oral+Pf-06651600+And+Pf-06700841+As+Induction+And+Open+Label+Extension+Treatment+In+Subjects+With+Moderate+To+Severe+Crohn%E2%80%99s+Disease [https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7981007&StudyName=A+Phase+2a%2C+Double-blind%2C+Randomized%2C+Placebo-controlled%2C+Parallel+Group+Study+To+Evaluate+The+Efficacy+And+Safety+Of+Oral+Pf-06651600+And+Pf-06700841+As+Induction+And+Open+Label+Extension+Treatment+In+Subjects+With+Moderate+To+Severe+Crohn%E2%80%99s+Disease] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To obtain contact information for a study center near you, click here.",null,"Yes","No",{"$nulls":17},"2017-003359-43|PIZZICATO","EudraCT Number|Alias Study Number","Proportion of subjects achieving clinically meaningful endoscopic improvement (reduction of more than or equal to 3 points from baseline in Simplified Endoscopic Activity Score for Crohn's Disease (SES-CD) at Week 12","12 weeks",null,"Number of participants with potentially clinically important serious infections findings|Mean change from baseline in SES-CD score at Week 12.|Proportion of subjects achieving SES-CD 25 and SES-CD 50 at Week 12.|Proportion of subjects achieving endoscopic remission (SES-CD less than or equal to 2) at Week 12.|Proportion of subjects achieving mucosal healing at Week 12.|Number of subjects with adverse events|Number of subjects with serious adverse events|Number of subjects with electrocardiogram findings of potential clinical importance.|Number of subjects withdrawal due to adverse events|Number of subjects with vital signs findings of potential clinical importance.|Number of subjects with laboratory tests findings of potential clinical importance.|Proportion of subjects achieving SES CD 25 and SES CD 50 at Week 64 among subjects who achieved SES CD 25 and SES CD 50 at week 12 respectively.|Proportion of subjects achieving clinically meaningful endoscopic improvement (CMEI response) at week 64 among subjects who achieved CMEI response at Week 12.","64 weeks|Baseline, week 12|Number of subjects achieving SES-CD 25 and SES-CD 50 at Week 12.|Number of subjects achieving endoscopic remission (SES-CD less than or equal to 2) at Week 12.|Number of subjects achieving mucosal healing at Week 12.|Number of participants with reported adverse events|Number of participants with reported serious adverse events|Number of participants with potentially clinically important electrocardiogram findings.|Number of subjects withdrawal due to adverse events.|Number of participants with potentially clinically important vital signs findings.|Number of participants with potentially clinically important laboratory findings.|Number of subjects achieving SES-CD 25 and SES-CD 50 at Week 64 among subjects who achieved SES CD 25 and SES CD 50 at week 12|Number of subject achieving clinically meaningful endoscopic improvement (CMEI response) at week 64 among subjects who achieved CMEI response at week 12.","Baseline, week 12|Week 12|Baseline up to 64 weeks|Baseline u to 64 weeks|week 64","ClinicalTrials.gov_Inquiries@pfizer.com","Pfizer CT.gov Call Center","1-800-718-1021","Concord, New South Wales, Australia, 2139|Subiaco, Western|Ballarat, Victoria, Australia, 3350|Leuven, Belgium, 3000 Chc - Saint-JosephLiÃ¨ge, Belgium, 4000|Tbilisi, Georgia, 0141 David Tatishvili Medical CenterTbilisi, Georgia, 0186|Budapest, Hungary, 1088 Szent Janos Korhaz Es Eszak-Budai Egyesitett KorhazakBudapest, Hungary, 1125 Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz, Endoszkopos LaboratoriumGyula, Hungary, 5700 Clinfan Szolgaltato Kft.Szekszard, Hungary, 7100 Korea, Republic Of, Korea Kyungpook National University HospitalDaegu, Korea, Korea, Republic Of, 41944 Korea, Republic Of Kangbuk Samsung HospitalSeoul, Korea, Republic Of, 03181 Severance Hospital, Yonsei University Health SystemSeoul, Korea, Republic Of, 03722 The Catholic University Of Korea, Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591|Katowice, Poland, 40-659 Etg KielceKielce, Poland, 25-355 Indywidualna Specjalstyczna Praktyka Lekarska Maciej ZymlaKnurow, Poland, 44-190 Szpital W Knurowie Sp. Z O.O.Knurow, Poland, 44-190 Centrum Badan Klinicznych JciKrakow, Poland, 30-348 Marta Dagmara Banach Marta Banach Specjalistyczny Gabinet NeurologicznyKrakow, Poland, 30-539 Centrum Medyczne EvitaKrakow, Poland, 31-153 Szpital Specjalistyczny Im. Ludwika Rydygiera W Krakowie Sp. Z O.O.Krakow, Poland, 31-826 Ai Centrum Medyczne Sp. Z O.O. Sp.K.Poznan, Poland, 61-113 Endoskopia Sp. Z O. O.Sopot, Poland, 81-756 Szpital Sredzki Serca Jezusowego Sp. Z O.O.Sroda Wielkopolska, Poland, 63-000 Ez-Med Sp. Z O.O. Sp.K.Swidnica, Poland, 58-100 Gastromed Kopon, Zmudzinski I Wspolnicy Sp.J.Torun, Poland, 87-100 Centrum Zdrowia MdmWarszawa, Poland, 00-635 Centrum Diagnostyczno-Lecznicze Barska Sp. Z O. O.Wloclawek, Poland, 87-800 Centrum Gastrologiczno HepatologiczneWroclaw, Poland, 50-555 LexmedicaWroclaw, Poland, 53-114 Russian Federation Sechenov University On The Base Of Institute Of Translational Medicine And BiotechnologyMoscow, Russian Federation, 119435 Limited Liability Company \"Medical Center Sibnovomed\"Novosibirsk, Russian Federation, 630005 Federal State Budgetary Scientific Institution \"Scientific Research Institute Of Physiology AndNovosibirsk, Russian Federation, 630117 Clinic At Fsbei He \"Omsk State Medical University\" Moh RfOmsk, Russian Federation, 644050 Llc \"New Clinic\"Pyatigorsk, Russian Federation, 357500 Llc \"Riat\"Saint-Petersburg, Russian Federation, 195220 Saint-Petersburg State Budgetary Healthcare Institution \"City Hospital #26\"Saint-Petersburg, Russian Federation, 196247 Private Institution Educational Organization Of Higher EducationSamara, Russian Federation, 443011 Non-State Healthcare Institution 'Railway Clinical Hospital At Samara Station Of Open Joint StockSamara, Russian Federation, 443029 Saint-Petersburg State Budgetary Healthcare Institution \"City Clinical Hospital Of The RighteousSt. Petersburg, Russian Federation, 197706|Brezno, Slovakia, 97701 Km Management Spol. S.R.O.Nitra, Slovakia, 949 01 Accout Center S.R.O. Gastroenterologicka AmbulanciaSahy, Slovakia, 936 01 Endomed, S.R.O.Vranov Nad Toplou, Slovakia, 093 01|Santander, Cantabria, Spain, 39008|Granada, Spain, 18014 Hospital Universitario Ramon Y CajalMadrid, Spain, 28034 Hospital Universitario Virgen Del RocioSevilla, Spain, 41013 Hospital Universitari I Politecnic La FeValencia, Spain, 46026|Ankara, Turkey, 06230 Hacettepe Universitesi Tip FakultesiAnkara, Turkey, 06230 Bezmialem Vakif Universitesi Tip Fakultesi HastanesiIstanbul, Turkey, 34093 Erciyes Universitesi Tip FakultesiKayseri, Turkey, 38039 Mersin Universitesi Tip Fakultesi Hastanesi, Ic HastaliklariMersin, Turkey, 33110 Mersin Universitesi Tip Fakultesi HastanesiMersin, Turkey, 33110 Karadeniz Teknik Universitesi Tip Fakultesi, Ic HastaliklariTrabzon, Turkey, 61080 Karadeniz Teknik Universitesi Tip FakultesiTrabzon, Turkey, 61080|Chernivtsi, Ukraine, 58001 Private Enterprise Of Private Manufacturing Company \"Acinus\", Medical And Diagnostic CenterKropyvnytskyi, Ukraine, 25006 Kyiv Municipal Clinical Hospital #18, Proctology DepartmentKyiv, Ukraine, 01030 Medical Center \"Universal Clinic Oberig\" Of \"Kapital\" Llc, Gastro CenterKyiv, Ukraine, 03680 Lviv Clinical Hospital On Railway Transport Of Health Care Center Branch Of Pjsc Ukrainian RailwayLviv, Ukraine, 79007 Private Small-Scale Enterprise Medical Center \"Pulse\"Vinnytsia, Ukraine, 21001|Dothan, Alabama, United States, 36301 Gut P.C., Dba Digestive Health Specialists Of The SoutheastDothan, Alabama, United States, 36305|Beverly Hills, California, United States, 90210 Long Beach Clinical Trial Services, Inc.Long Beach, California, United States, 90806 Entertainment Medical GroupLos Angeles, California, United States, 90036 Gastrointestinal Biosciences Clinical Trials, LlcLos Angeles, California, United States, 90067 Alliance Clinical Research, LlcPoway, California, United States, 92064|Clearwater, Florida, United States, 33756-3839 West Coast Endoscopy CenterClearwater, Florida, United States, 33756 Gastro FloridaClearwater, Florida, United States, 33762 Millenia Surgery CenterOrlando, Florida, United States, 32811 Hmd Research LlcOrlando, Florida, United States, 32819 Orlando Gastroenterology, PaOrlando, Florida, United States, 32835|Houma, Louisiana, United States, 70360 Gulf Coast Surgical CenterHouma, Louisiana, United States, 70360 The Hearing Center (Audiology)Houma, Louisiana, United States, 70360|Chevy Chase, Maryland, United States, 20815 Mgg Group Co., Inc., Chevy Chase Clinical ResearchChevy Chase, Maryland, United States, 20815|Boston, Massachusetts, United States, 02115 Brigham And Women'S HospitalBoston, Massachusetts, United States, 02115 Mass Eye And Ear, LongwoodBoston, Massachusetts, United States, 02115 Brigham And Women'S Hospital (Endoscopy)Chestnut Hill, Massachusetts, United States, 02467 Umass Memorial Medical CenterWorcester, Massachusetts, United States, 01655 University Of Massachusetts Medical SchoolWorcester, Massachusetts, United States, 01655|Chesterfield, Michigan, United States, 48047 Eastside Endoscopy CenterMacomb, Michigan, United States, 48044|New York, New York, United States, 10021 New York Presbyterian Hospital - Weill Cornell Medical College (Colonoscopy)New York, New York, United States, 10065 New York Presbyterian Hospital - Weill Cornell Medical College Investigational PharmacyNew York, New York, United States, 10065 Weill Cornell Medical College - New York Presbyterian Hospital (Endoscopy Suite)New York, New York, United States, 10065 Weill Cornell Medical College - New York Presbyterian HospitalNew York, New York, United States, 10065 Digiovanna Institute For Medical Education & ResearchNorth Massapequa, New York, United States, 11758-1802|Chapel Hill, North Carolina, United States, 27514 Unc Hospitals Endoscopy Center At MeadowmontChapel Hill, North Carolina, United States, 27517 University Of North Carolina At Chapel HillChapel Hill, North Carolina, United States, 27599 Gastroenterology Associates Of The Piedmont, PaWinston-Salem, North Carolina, United States, 27103 Pmg Research Of Winston-Salem, LlcWinston-Salem, North Carolina, United States, 27103|Kingsport, Tennessee, United States, 37660 Holston Medical GroupKingsport, Tennessee, United States, 37660 Holston Valley Surgery Center (Testing Only)Kingsport, Tennessee, United States, 37660|Arlington, Texas, United States, 76012 Envision Imaging (Cxr)Arlington, Texas, United States, 76012 Texas Clinical Research Institiute, LlcArlington, Texas, United States, 76012 Hermann Drive Surgical HospitalHouston, Texas, United States, 77004 Pearland Surgery CenterHouston, Texas, United States, 77047 Gulf Coast Research Group, LlcHouston, Texas, United States, 77098 Lonestar Endoscopy, LlpSouthlake, Texas, United States, 76092 Texas Digestive Disease ConsultantsSouthlake, Texas, United States, 76092|Fairfax, Virginia, United States, 22031","Alabama|California|Florida|Louisiana|Maryland|Massachusetts|Michigan|New York|North Carolina|Tennessee|Texas|Virginia","Australia|Belgium|Georgia|Hungary|Poland|Slovakia|Spain|Turkey|Ukraine|United States","New South Wales Concord Repatriation General Hospital|Saint John Of God Subiaco Hospital|Victoria Ballarat Base Hospital|University Hospitals Leuven|The First University Clinic Of Tsmu|Semmelweis Egyetem, Ii. Belgyogyaszati Klinika|Niepubliczny Zaklad Opieki Zdrowotnej All-Medicus|Breznianske Centrum Gastroenterologie S.R.O.|Cantabria Hospital Universitario Marques De Valdecilla|Hospital Universitario Virgen De Las Nieves De Granada|Hacettepe Universitesi Tip Fakultesi, Ic Hastaliklari Anabilim|Regional Municipal Institution \"Chernivtsi Regional Clinical Hospital\", Gastroenterology Department,|Dothan Surgery Center (Colonoscopy And Tissue Biopsy Location)|Brighton Surgical Center|Gastro Florida|Cronola, Llc|Chevy Chase Endoscopy Center|Brigham And Women's Hospital (Drug Shipment Only)|Clinical Research Institute Of Michigan, Llc|Weill Cornell Medical College (Clinical Site)|Unc Hospitals|Holston Medical Group (Drug Shipment Only)|Cross Timbers Surgery Center L.P. (Colonoscopy)|Verity Research, Inc.",{"$nulls":3},"Pfizer CT.gov Call Center","2018-08-16","2020-05-25T16:36:03.159","2020-05-26T17:10:42.972","NCT03395184"]
["5ecbf3f3307e3d1b1f8d9c9a","NCT03395184","2018-09-14","Pfizer","PFE","Recruiting","Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PFâ€‘06700841 In Subjects With Moderate To Severe Crohn's Disease","Brepocitinib|Pf-06651600","JAK1 Inhibitor|TYK2 Inhibitor|JAK1 Inhibitor|JAK3 Inhibitor","Yes","['Brepocitinib', 'Pf-06651600']","Yes","['TYK2 Inhibitor', 'JAK3 Inhibitor']","Phase 2",2,250,"Anticipated","2018-02-02","2020-02-04","DAS","Disease Activity Score",{"$nulls":3},"The objectives of this study are to evaluate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-06651600 (200 mg for 8 weeks followed by 50 mg for 4 weeks) dosed once daily and PF-06700841 (60 mg for 12 weeks) dosed once daily during an induction period of 12 weeks, followed by an open label extension period at doses of 50 mg and 30 mg of PF 06651600 and PF 06700841, respectively, for 52 weeks.",null,"A PHASE 2A, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ORAL PF-06651600 AND PF-06700841 AS INDUCTION AND OPEN LABEL EXTENSION TREATMENT IN SUBJECTS WITH MODERATE TO SEVERE CROHN'S DISEASE","B7981007","Crohn's Disease","Crohn Disease","Gastrointestinal Diseases","Gastrointestinal","Experimental","PF-06700841 or placebo|PF-06651600 or placebo",null,"Drug","Placebo PF-06700841|PF-06700841|Placebo PF-06651600|PF-06651600","12 weeks, followed by PF-06700841, 30 mg QD for 52 weeks.|60 mg QD for 12 weeks followed by 30 mg QD for up to 52 weeks|12 weeks, followed by PF-06651600, 50 mg QD for 52 weeks|200 mg QD for 8 weeks, followed by 50 mg QD up to 56 weeks",null,"PF-06700841 or placebo|PF-06651600 or placebo","\n\n 1. Male and/or female subjects 18 years to 75 years of age\n 2. Documented diagnosis of ileal, ileocolonic, or colonic CD with a minimum disease duration of 3 months, as determined by endoscopic and histopathology assessment.\n 3. Endoscopic confirmation of active disease with total SES CD total score of at least 7. For isolated ileal disease, SES CD total score should be at least 4.\n 4. An average daily liquid/soft stool frequency (SF) greater than or equal to 2.5 or daily abdominal pain (AP) greater than or equal to 2.0.\n 5. Must have inadequate response to, loss of response to, or intolerance to at least one conventional therapy for CD:â€¢Steroids; Immunosuppressants (azathioprine [AZA], 6 MP, or methotrexate [MTX]); Anti TNF inhibitors (infliximab, adalimumab,certolizumab); Anti integrin inhibitors (eg, vedolizumab); Anti IL 12/23 inhibitor (ustekinumab).\n    \n    \n 6. Subjects currently receiving the following treatment for CD are eligible providing they have been on stable doses as described below: * Oral corticosteroids (prednisone or equivalent up to 25 mg/day; budesonide up to 9 mg/day). Stable dose for at least 2 weeks prior to baseline. If oral corticosteroids have been recently discontinued, they must have been stopped at least 2 weeks prior to baseline. Decreases in steroid use due to AEs are allowed.\n     * Oral 5 ASA or sulfasalazine are allowed providing that the dose is stable for at least 4 weeks prior to baseline.\n     * Crohn's disease related antibiotics are allowed providing that the dose is stable for at least 4 weeks prior to baseline. If antibiotics are stopped prior to baseline, they must be discontinued at least 4 days prior to baseline.\n    \n    \n\n","\n\n 1.  Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, diverticular disease, ulcerative colitis (UC), or clinical findings suggestive of UC.\n 2.  Presence of active (draining) fistulae or intra abdominal or perineal abscesses.\n 3.  Strictures with obstructive symptoms.\n 4.  Short bowel syndrome.\n 5.  History of bowel perforation requiring surgical intervention within the past 12 months.\n 6.  Previous bowel surgery resulting in an existing stoma. Subjects who have a j pouch are excluded, as a j pouch can result in a stoma.\n 7.  History of bowel surgery within 6 months prior to baseline.\n 8.  Subjects displaying clinical signs of fulminant colitis or toxic megacolon.\n 9.  Subjects with primary sclerosing cholangitis.\n 10. Subjects with evidence of colonic adenomas, dysplasia or neoplasia.\n 11. Abnormal findings on the chest x ray film such as presence of tuberculosis (TB), general infections, heart failure, or malignancy.\n 12. Any history of either untreated or inadequately treated latent or active TB infection, current treatment for active or latent TB infection or evidence of currently active TB by chest x ray, residing with or frequent close contact with individual(s) with active TB.\n 13. Subjects receiving the following therapies within the time period described below or expected to receive any of these therapies during the study period: 1.  >9 mg/day of oral budesonide or >25 mg/day of prednisone or equivalent oral systemic corticosteroid dose within 2 weeks prior to baseline.\n      2.  IV, IM (parenteral), or topical (rectal) treatment of 5 ASA or corticosteroid enemas/suppositories within 2 weeks prior to baseline.\n      3.  Azathioprine, 6 mercaptopurine, or methotrexate within 2 weeks prior to baseline.\n      4.  Anti TNF inhibitors (or biosimilars thereof) as described below: * Infliximab within 8 weeks prior to baseline;\n           * Adalimumab within 8 weeks prior to baseline;\n           * Certolizumab within 8 weeks prior to baseline;\n          \n          \n      5.  Anti integrin inhibitors (eg, vedolizumab) within 8 weeks prior to baseline.\n      6.  Ustekinumab within 8 weeks prior to baseline.\n      7.  Interferon therapy within 8 weeks prior to baseline.\n      8.  Subjects with prior treatment with lymphocyte depleting agents/therapies within 1 year prior to baseline (eg, CamPath[alemtuzumab], alkylating agents [eg, cyclophosphamide or chlorambucil], total lymphoid irradiation, etc).\n      9.  Subjects who have received rituximab or other selective B lymphocyte depleting agents within 1 year prior to baseline.\n      10. Subjects previously receiving leukocyte apheresis, including selective lymphocyte, monocyte, or granulocyte apheresis, or plasma exchange within 6 months prior to baseline.\n      11. Other marketed immunosuppressants or biologics with immunomodulatory properties within 3 months prior to baseline.\n      12. Subjects who have received other JAK inhibitors within 3 months prior to baseline.\n      13. Subjects who have not responded to or have been intolerant of other JAK inhibitors.\n      14. Other investigational procedures(s) or product(s), such as immunosuppressants used in transplantation (eg, mycophenolate mofetil, cyclosporine, rapamycin, or tacrolimus) or live (attenuated) vaccine within 30 days prior to baseline.","TNF","tumor necrosis factor","Protein","Lung, Breast, Ovary","Actual","2018-01-10","Actual","Anticipated","2021-02-18","Anticipated","2018-09-01","2017-12-05","2018-01-03","2018-09-13","Yes",null,"Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years","75 Years","All",null,"No","Yes\nInformation relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests",null,"URL: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7981007&StudyName=A+Phase+2a%2C+Double-blind%2C+Randomized%2C+Placebo-controlled%2C+Parallel+Group+Study+To+Evaluate+The+Efficacy+And+Safety+Of+Oral+Pf-06651600+And+Pf-06700841+As+Induction+And+Open+Label+Extension+Treatment+In+Subjects+With+Moderate+To+Severe+Crohn%E2%80%99s+Disease [https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7981007&StudyName=A+Phase+2a%2C+Double-blind%2C+Randomized%2C+Placebo-controlled%2C+Parallel+Group+Study+To+Evaluate+The+Efficacy+And+Safety+Of+Oral+Pf-06651600+And+Pf-06700841+As+Induction+And+Open+Label+Extension+Treatment+In+Subjects+With+Moderate+To+Severe+Crohn%E2%80%99s+Disease] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To obtain contact information for a study center near you, click here.",null,"Yes","No",{"$nulls":17},"2017-003359-43|PIZZICATO","EudraCT Number|Alias Study Number","Proportion of subjects achieving clinically meaningful endoscopic improvement (reduction of more than or equal to 3 points from baseline in Simplified Endoscopic Activity Score for Crohn's Disease (SES-CD) at Week 12","12 weeks",null,"Number of participants with potentially clinically important serious infections findings|Mean change from baseline in SES-CD score at Week 12.|Proportion of subjects achieving SES-CD 25 and SES-CD 50 at Week 12.|Proportion of subjects achieving endoscopic remission (SES-CD less than or equal to 2) at Week 12.|Proportion of subjects achieving mucosal healing at Week 12.|Number of subjects with adverse events|Number of subjects with serious adverse events|Number of subjects with electrocardiogram findings of potential clinical importance.|Number of subjects withdrawal due to adverse events|Number of subjects with vital signs findings of potential clinical importance.|Number of subjects with laboratory tests findings of potential clinical importance.|Proportion of subjects achieving SES CD 25 and SES CD 50 at Week 64 among subjects who achieved SES CD 25 and SES CD 50 at week 12 respectively.|Proportion of subjects achieving clinically meaningful endoscopic improvement (CMEI response) at week 64 among subjects who achieved CMEI response at Week 12.","64 weeks|Baseline, week 12|Number of subjects achieving SES-CD 25 and SES-CD 50 at Week 12.|Number of subjects achieving endoscopic remission (SES-CD less than or equal to 2) at Week 12.|Number of subjects achieving mucosal healing at Week 12.|Number of participants with reported adverse events|Number of participants with reported serious adverse events|Number of participants with potentially clinically important electrocardiogram findings.|Number of subjects withdrawal due to adverse events.|Number of participants with potentially clinically important vital signs findings.|Number of participants with potentially clinically important laboratory findings.|Number of subjects achieving SES-CD 25 and SES-CD 50 at Week 64 among subjects who achieved SES CD 25 and SES CD 50 at week 12|Number of subject achieving clinically meaningful endoscopic improvement (CMEI response) at week 64 among subjects who achieved CMEI response at week 12.","Baseline, week 12|Week 12|Baseline up to 64 weeks|Baseline u to 64 weeks|week 64","ClinicalTrials.gov_Inquiries@pfizer.com","Pfizer CT.gov Call Center","1-800-718-1021","Concord, New South Wales, Australia, 2139|Subiaco, Western|Ballarat, Victoria, Australia, 3350|Leuven, Belgium, 3000 Chc - Saint-JosephLiÃ¨ge, Belgium, 4000|Zadar, Croatia, 23000|Tbilisi, Georgia, 0141 David Tatishvili Medical CenterTbilisi, Georgia, 0186|Bekescsaba, Hungary, 5600 Semmelweis Egyetem, Ii. Belgyogyaszati KlinikaBudapest, Hungary, 1088 Szent Janos Korhaz Es Eszak-Budai Egyesitett KorhazakBudapest, Hungary, 1125 Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz, Endoszkopos LaboratoriumGyula, Hungary, 5700 Clinfan Szolgaltato Kft.Szekszard, Hungary, 7100 Korea, Republic Of, Korea Kyungpook National University HospitalDaegu, Korea, Korea, Republic Of, 41944|Katowice, Poland, 40-659 Etg KielceKielce, Poland, 25-355 Indywidualna Specjalstyczna Praktyka Lekarska Maciej ZymlaKnurow, Poland, 44-190 Szpital W Knurowie Sp. Z O.O.Knurow, Poland, 44-190 Centrum Badan Klinicznych JciKrakow, Poland, 30-348 Marta Dagmara Banach Marta Banach Specjalistyczny Gabinet NeurologicznyKrakow, Poland, 30-539 Centrum Medyczne EvitaKrakow, Poland, 31-153 Szpital Specjalistyczny Im. Ludwika Rydygiera W Krakowie Sp. Z O.O.Krakow, Poland, 31-826 Ai Centrum Medyczne Sp. Z O.O. Sp.K.Poznan, Poland, 61-113 Endoskopia Sp. Z O. O.Sopot, Poland, 81-756 Szpital Sredzki Serca Jezusowego Sp. Z O.O.Sroda Wielkopolska, Poland, 63-000 Ez-Med Sp. Z O.O. Sp.K.Swidnica, Poland, 58-100 Gastromed Kopon, Zmudzinski I Wspolnicy Sp.J.Torun, Poland, 87-100 Centrum Zdrowia MdmWarszawa, Poland, 00-635 Centrum Diagnostyczno-Lecznicze Barska Sp. Z O. O.Wloclawek, Poland, 87-800 Centrum Gastrologiczno HepatologiczneWroclaw, Poland, 50-555 LexmedicaWroclaw, Poland, 53-114 Russian Federation Sechenov University On The Base Of Institute Of Translational Medicine And BiotechnologyMoscow, Russian Federation, 119435 Limited Liability Company \"Medical Center Sibnovomed\"Novosibirsk, Russian Federation, 630005 Federal State Budgetary Scientific Institution \"Scientific Research Institute Of Physiology AndNovosibirsk, Russian Federation, 630117 Clinic At Fsbei He \"Omsk State Medical University\" Moh RfOmsk, Russian Federation, 644050 Llc \"New Clinic\"Pyatigorsk, Russian Federation, 357500 Llc \"Riat\"Saint-Petersburg, Russian Federation, 195220 Saint-Petersburg State Budgetary Healthcare Institution \"City Hospital #26\"Saint-Petersburg, Russian Federation, 196247 Private Institution Educational Organization Of Higher EducationSamara, Russian Federation, 443011 Non-State Healthcare Institution 'Railway Clinical Hospital At Samara Station Of Open Joint StockSamara, Russian Federation, 443029 Saint-Petersburg State Budgetary Healthcare Institution \"City Clinical Hospital Of The RighteousSt. Petersburg, Russian Federation, 197706|Banska Bystrica, Slovakia, 975 17 Breznianske Centrum Gastroenterologie S.R.O.Brezno, Slovakia, 97701 Km Management Spol. S.R.O.Nitra, Slovakia, 949 01 Accout Center S.R.O. Gastroenterologicka AmbulanciaSahy, Slovakia, 936 01 Endomed, S.R.O.Vranov Nad Toplou, Slovakia, 093 01|Santander, Cantabria, Spain, 39008|Granada, Spain, 18014 Hospital Universitario Ramon Y CajalMadrid, Spain, 28034 Hospital Universitario Virgen Del RocioSevilla, Spain, 41013 Hospital Universitari I Politecnic La FeValencia, Spain, 46026|Ankara, Turkey, 06100 Ankara Universitesi Tip Fakultesi, Ibn-I Sina HastanesiAnkara, Turkey, 06100 Hacettepe Universitesi Tip Fakultesi, Ic Hastaliklari AnabilimAnkara, Turkey, 06230 Hacettepe Universitesi Tip FakultesiAnkara, Turkey, 06230 Bezmialem Vakif Universitesi Tip Fakultesi HastanesiIstanbul, Turkey, 34093 Istanbul Universitesi Cerrahpasa Tip FakultesiIstanbul, Turkey, 34098 Erciyes Universitesi Tip FakultesiKayseri, Turkey, 38039 Mersin Universitesi Tip Fakultesi Hastanesi, Ic HastaliklariMersin, Turkey, 33110 Mersin Universitesi Tip Fakultesi HastanesiMersin, Turkey, 33110 Karadeniz Teknik Universitesi Tip Fakultesi, Ic HastaliklariTrabzon, Turkey, 61080 Karadeniz Teknik Universitesi Tip FakultesiTrabzon, Turkey, 61080 Bulent Ecevit Universitesi Tip FakultesiZonguldak, Turkey, 67600|Chernivtsi, Ukraine, 58001 Regional Municipal Institution \"Chernivtsi Regional Clinical Hospital\", Surgery DepartmentChernivtsi, Ukraine, 58001 Private Enterprise Of Private Manufacturing Company \"Acinus\", Medical And Diagnostic CenterKropyvnytskyi, Ukraine, 25006 Kyiv Municipal Clinical Hospital #18, Proctology DepartmentKyiv, Ukraine, 01030 Medical Center \"Universal Clinic Oberig\" Of \"Kapital\" Llc, Gastro CenterKyiv, Ukraine, 03680 Lviv Clinical Hospital On Railway Transport Of Health Care Center Branch Of Pjsc Ukrainian RailwayLviv, Ukraine, 79007 Vinnytsia City Clinical Hospital No.1Vinnytsia, Ukraine, 21000 Private Small-Scale Enterprise Medical Center \"Pulse\"Vinnytsia, Ukraine, 21001 Vinnytsia Regional Clinical Hospital For War VeteransVinnytsia, Ukraine, 21005|Dothan, Alabama, United States, 36301 Gut P.C., Dba Digestive Health Specialists Of The SoutheastDothan, Alabama, United States, 36305|Beverly Hills, California, United States, 90210 Long Beach Clinical Trial Services, Inc.Long Beach, California, United States, 90806 Entertainment Medical GroupLos Angeles, California, United States, 90036 Gastrointestinal Biosciences Clinical Trials, LlcLos Angeles, California, United States, 90067 Alliance Clinical Research, LlcPoway, California, United States, 92064|Clearwater, Florida, United States, 33756-3839 West Coast Endoscopy CenterClearwater, Florida, United States, 33756 Gastro FloridaClearwater, Florida, United States, 33762 Millenia Surgery CenterOrlando, Florida, United States, 32811 Hmd Research LlcOrlando, Florida, United States, 32819 Orlando Gastroenterology, PaOrlando, Florida, United States, 32835|Houma, Louisiana, United States, 70360 Gulf Coast Surgical CenterHouma, Louisiana, United States, 70360 The Hearing Center (Audiology)Houma, Louisiana, United States, 70360|Chevy Chase, Maryland, United States, 20815 Mgg Group Co., Inc., Chevy Chase Clinical ResearchChevy Chase, Maryland, United States, 20815|Boston, Massachusetts, United States, 02115 Mass Eye And Ear, LongwoodBoston, Massachusetts, United States, 02115 Brigham And Women'S HospitalChestnut Hill, Massachusetts, United States, 02467 Umass Memorial Medical CenterWorcester, Massachusetts, United States, 01655 University Of Massachusetts Medical SchoolWorcester, Massachusetts, United States, 01655|Chesterfield, Michigan, United States, 48047 Eastside Endoscopy CenterMacomb, Michigan, United States, 48044|New York, New York, United States, 10021 New York Presbyterian Hospital - Weill Cornell Medical College (Colonoscopy)New York, New York, United States, 10065 New York Presbyterian Hospital - Weill Cornell Medical College Investigational PharmacyNew York, New York, United States, 10065 Weill Cornell Medical College - New York Presbyterian Hospital (Endoscopy Suite)New York, New York, United States, 10065 Weill Cornell Medical College - New York Presbyterian HospitalNew York, New York, United States, 10065 Digiovanna Institute For Medical Education & ResearchNorth Massapequa, New York, United States, 11758-1802|Chapel Hill, North Carolina, United States, 27514 Unc Hospitals Endoscopy Center At MeadowmontChapel Hill, North Carolina, United States, 27517 University Of North Carolina At Chapel HillChapel Hill, North Carolina, United States, 27599 Gastroenterology Associates Of The Piedmont, PaWinston-Salem, North Carolina, United States, 27103 Pmg Research Of Winston-Salem, LlcWinston-Salem, North Carolina, United States, 27103|Kingsport, Tennessee, United States, 37660 Holston Medical GroupKingsport, Tennessee, United States, 37660 Holston Valley Surgery Center (Testing Only)Kingsport, Tennessee, United States, 37660|Arlington, Texas, United States, 76012 Envision Imaging (Cxr)Arlington, Texas, United States, 76012 Texas Clinical Research Institiute, LlcArlington, Texas, United States, 76012 Hermann Drive Surgical HospitalHouston, Texas, United States, 77004 Pearland Surgery CenterHouston, Texas, United States, 77047 Gulf Coast Research Group, LlcHouston, Texas, United States, 77098 North Texas Research AssociatesMckinney, Texas, United States, 75069 Lonestar Endoscopy, LlpSouthlake, Texas, United States, 76092 Texas Digestive Disease ConsultantsSouthlake, Texas, United States, 76092|Fairfax, Virginia, United States, 22031","Alabama|California|Florida|Louisiana|Maryland|Massachusetts|Michigan|New York|North Carolina|Tennessee|Texas|Virginia","Australia|Belgium|Croatia|Georgia|Hungary|Poland|Slovakia|Spain|Turkey|Ukraine|United States","New South Wales Concord Repatriation General Hospital|Saint John Of God Subiaco Hospital|Victoria Ballarat Base Hospital|University Hospitals Leuven|Opca Bolnica Zadar, Odjel Za Gastroenterologiju|The First University Clinic Of Tsmu|Bekes Megyei Kozponti Korhaz, Rethy Pal Tagkorhaz|Niepubliczny Zaklad Opieki Zdrowotnej All-Medicus|Fakultna Nemocnica S Poliklinikou F.D. Roosevelta Banska Bystrica|Cantabria Hospital Universitario Marques De Valdecilla|Hospital Universitario Virgen De Las Nieves De Granada|Ankara Universitesi Tip Fakultesi, Ibn-I Sina Hastanesi, Ic Hastaliklari Anabilim Dali,|Regional Municipal Institution \"Chernivtsi Regional Clinical Hospital\", Gastroenterology Department,|Dothan Surgery Center|Brighton Surgical Center|Gastro Florida|Cronola, Llc|Chevy Chase Endoscopy Center|Brigham And Women's Hospital|Clinical Research Institute Of Michigan, Llc|Weill Cornell Medical College (Clinical Site)|Unc Hospitals|Holston Medical Group (Drug Shipment Only)|Cross Timbers Surgery Center L.P. (Colonoscopy)|Verity Research, Inc.",{"$nulls":3},"Pfizer CT.gov Call Center","2018-09-13","2020-05-25T16:36:03.269","2020-05-26T17:10:42.972","NCT03395184"]
["5ecbf3f311702c1b1b916a1b","NCT03395184","2018-09-25","Pfizer","PFE","Recruiting","Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PFâ€‘06700841 In Subjects With Moderate To Severe Crohn's Disease","Brepocitinib|Pf-06651600","JAK1 Inhibitor|TYK2 Inhibitor|JAK1 Inhibitor|JAK3 Inhibitor","Yes","['Brepocitinib', 'Pf-06651600']","Yes","['TYK2 Inhibitor', 'JAK3 Inhibitor']","Phase 2",2,250,"Anticipated","2018-02-02","2020-02-04","DAS","Disease Activity Score",{"$nulls":3},"The objectives of this study are to evaluate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-06651600 (200 mg for 8 weeks followed by 50 mg for 4 weeks) dosed once daily and PF-06700841 (60 mg for 12 weeks) dosed once daily during an induction period of 12 weeks, followed by an open label extension period at doses of 50 mg and 30 mg of PF 06651600 and PF 06700841, respectively, for 52 weeks.",null,"A PHASE 2A, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ORAL PF-06651600 AND PF-06700841 AS INDUCTION AND OPEN LABEL EXTENSION TREATMENT IN SUBJECTS WITH MODERATE TO SEVERE CROHN'S DISEASE","B7981007","Crohn's Disease","Crohn Disease","Gastrointestinal Diseases","Gastrointestinal","Experimental","PF-06700841 or placebo|PF-06651600 or placebo",null,"Drug","Placebo PF-06700841|PF-06700841|Placebo PF-06651600|PF-06651600","12 weeks, followed by PF-06700841, 30 mg QD for 52 weeks.|60 mg QD for 12 weeks followed by 30 mg QD for up to 52 weeks|12 weeks, followed by PF-06651600, 50 mg QD for 52 weeks|200 mg QD for 8 weeks, followed by 50 mg QD up to 56 weeks",null,"PF-06700841 or placebo|PF-06651600 or placebo","\n\n 1. Male and/or female subjects 18 years to 75 years of age\n 2. Documented diagnosis of ileal, ileocolonic, or colonic CD with a minimum disease duration of 3 months, as determined by endoscopic and histopathology assessment.\n 3. Endoscopic confirmation of active disease with total SES CD total score of at least 7. For isolated ileal disease, SES CD total score should be at least 4.\n 4. An average daily liquid/soft stool frequency (SF) greater than or equal to 2.5 or daily abdominal pain (AP) greater than or equal to 2.0.\n 5. Must have inadequate response to, loss of response to, or intolerance to at least one conventional therapy for CD:â€¢Steroids; Immunosuppressants (azathioprine [AZA], 6 MP, or methotrexate [MTX]); Anti TNF inhibitors (infliximab, adalimumab,certolizumab); Anti integrin inhibitors (eg, vedolizumab); Anti IL 12/23 inhibitor (ustekinumab).\n    \n    \n 6. Subjects currently receiving the following treatment for CD are eligible providing they have been on stable doses as described below: * Oral corticosteroids (prednisone or equivalent up to 25 mg/day; budesonide up to 9 mg/day). Stable dose for at least 2 weeks prior to baseline. If oral corticosteroids have been recently discontinued, they must have been stopped at least 2 weeks prior to baseline. Decreases in steroid use due to AEs are allowed.\n     * Oral 5 ASA or sulfasalazine are allowed providing that the dose is stable for at least 4 weeks prior to baseline.\n     * Crohn's disease related antibiotics are allowed providing that the dose is stable for at least 4 weeks prior to baseline. If antibiotics are stopped prior to baseline, they must be discontinued at least 4 days prior to baseline.\n    \n    \n\n","\n\n 1.  Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, diverticular disease, ulcerative colitis (UC), or clinical findings suggestive of UC.\n 2.  Presence of active (draining) fistulae or intra abdominal or perineal abscesses.\n 3.  Strictures with obstructive symptoms.\n 4.  Short bowel syndrome.\n 5.  History of bowel perforation requiring surgical intervention within the past 12 months.\n 6.  Previous bowel surgery resulting in an existing stoma. Subjects who have a j pouch are excluded, as a j pouch can result in a stoma.\n 7.  History of bowel surgery within 6 months prior to baseline.\n 8.  Subjects displaying clinical signs of fulminant colitis or toxic megacolon.\n 9.  Subjects with primary sclerosing cholangitis.\n 10. Subjects with evidence of colonic adenomas, dysplasia or neoplasia.\n 11. Abnormal findings on the chest x ray film such as presence of tuberculosis (TB), general infections, heart failure, or malignancy.\n 12. Any history of either untreated or inadequately treated latent or active TB infection, current treatment for active or latent TB infection or evidence of currently active TB by chest x ray, residing with or frequent close contact with individual(s) with active TB.\n 13. Subjects receiving the following therapies within the time period described below or expected to receive any of these therapies during the study period: 1.  >9 mg/day of oral budesonide or >25 mg/day of prednisone or equivalent oral systemic corticosteroid dose within 2 weeks prior to baseline.\n      2.  IV, IM (parenteral), or topical (rectal) treatment of 5 ASA or corticosteroid enemas/suppositories within 2 weeks prior to baseline.\n      3.  Azathioprine, 6 mercaptopurine, or methotrexate within 2 weeks prior to baseline.\n      4.  Anti TNF inhibitors (or biosimilars thereof) as described below: * Infliximab within 8 weeks prior to baseline;\n           * Adalimumab within 8 weeks prior to baseline;\n           * Certolizumab within 8 weeks prior to baseline;\n          \n          \n      5.  Anti integrin inhibitors (eg, vedolizumab) within 8 weeks prior to baseline.\n      6.  Ustekinumab within 8 weeks prior to baseline.\n      7.  Interferon therapy within 8 weeks prior to baseline.\n      8.  Subjects with prior treatment with lymphocyte depleting agents/therapies within 1 year prior to baseline (eg, CamPath[alemtuzumab], alkylating agents [eg, cyclophosphamide or chlorambucil], total lymphoid irradiation, etc).\n      9.  Subjects who have received rituximab or other selective B lymphocyte depleting agents within 1 year prior to baseline.\n      10. Subjects previously receiving leukocyte apheresis, including selective lymphocyte, monocyte, or granulocyte apheresis, or plasma exchange within 6 months prior to baseline.\n      11. Other marketed immunosuppressants or biologics with immunomodulatory properties within 3 months prior to baseline.\n      12. Subjects who have received other JAK inhibitors within 3 months prior to baseline.\n      13. Subjects who have not responded to or have been intolerant of other JAK inhibitors.\n      14. Other investigational procedures(s) or product(s), such as immunosuppressants used in transplantation (eg, mycophenolate mofetil, cyclosporine, rapamycin, or tacrolimus) or live (attenuated) vaccine within 30 days prior to baseline.","TNF","tumor necrosis factor","Protein","Lung, Breast, Ovary","Actual","2018-01-10","Actual","Anticipated","2021-02-18","Anticipated","2018-09-01","2017-12-05","2018-01-03","2018-09-24","Yes",null,"Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years","75 Years","All",null,"No","Yes\nInformation relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests",null,"URL: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7981007&StudyName=A+Phase+2a%2C+Double-blind%2C+Randomized%2C+Placebo-controlled%2C+Parallel+Group+Study+To+Evaluate+The+Efficacy+And+Safety+Of+Oral+Pf-06651600+And+Pf-06700841+As+Induction+And+Open+Label+Extension+Treatment+In+Subjects+With+Moderate+To+Severe+Crohn%E2%80%99s+Disease [https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7981007&StudyName=A+Phase+2a%2C+Double-blind%2C+Randomized%2C+Placebo-controlled%2C+Parallel+Group+Study+To+Evaluate+The+Efficacy+And+Safety+Of+Oral+Pf-06651600+And+Pf-06700841+As+Induction+And+Open+Label+Extension+Treatment+In+Subjects+With+Moderate+To+Severe+Crohn%E2%80%99s+Disease] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To obtain contact information for a study center near you, click here.",null,"Yes","No",{"$nulls":17},"2017-003359-43|PIZZICATO","EudraCT Number|Alias Study Number","Proportion of subjects achieving clinically meaningful endoscopic improvement (reduction of more than or equal to 3 points from baseline in Simplified Endoscopic Activity Score for Crohn's Disease (SES-CD) at Week 12","12 weeks",null,"Number of participants with potentially clinically important serious infections findings|Mean change from baseline in SES-CD score at Week 12.|Proportion of subjects achieving SES-CD 25 and SES-CD 50 at Week 12.|Proportion of subjects achieving endoscopic remission (SES-CD less than or equal to 2) at Week 12.|Proportion of subjects achieving mucosal healing at Week 12.|Number of subjects with adverse events|Number of subjects with serious adverse events|Number of subjects with electrocardiogram findings of potential clinical importance.|Number of subjects withdrawal due to adverse events|Number of subjects with vital signs findings of potential clinical importance.|Number of subjects with laboratory tests findings of potential clinical importance.|Proportion of subjects achieving SES CD 25 and SES CD 50 at Week 64 among subjects who achieved SES CD 25 and SES CD 50 at week 12 respectively.|Proportion of subjects achieving clinically meaningful endoscopic improvement (CMEI response) at week 64 among subjects who achieved CMEI response at Week 12.","64 weeks|Baseline, week 12|Number of subjects achieving SES-CD 25 and SES-CD 50 at Week 12.|Number of subjects achieving endoscopic remission (SES-CD less than or equal to 2) at Week 12.|Number of subjects achieving mucosal healing at Week 12.|Number of participants with reported adverse events|Number of participants with reported serious adverse events|Number of participants with potentially clinically important electrocardiogram findings.|Number of subjects withdrawal due to adverse events.|Number of participants with potentially clinically important vital signs findings.|Number of participants with potentially clinically important laboratory findings.|Number of subjects achieving SES-CD 25 and SES-CD 50 at Week 64 among subjects who achieved SES CD 25 and SES CD 50 at week 12|Number of subject achieving clinically meaningful endoscopic improvement (CMEI response) at week 64 among subjects who achieved CMEI response at week 12.","Baseline, week 12|Week 12|Baseline up to 64 weeks|Baseline u to 64 weeks|week 64","ClinicalTrials.gov_Inquiries@pfizer.com","Pfizer CT.gov Call Center","1-800-718-1021","Concord, New South Wales, Australia, 2139|Subiaco, Western|Ballarat, Victoria, Australia, 3350|Jette, Belgium, 1090 University Hospitals LeuvenLeuven, Belgium, 3000 Chc - Saint-JosephLiÃ¨ge, Belgium, 4000|Zadar, Croatia, 23000|Tbilisi, Georgia, 0141 David Tatishvili Medical CenterTbilisi, Georgia, 0186|Bekescsaba, Hungary, 5600 Semmelweis Egyetem, Ii. Belgyogyaszati KlinikaBudapest, Hungary, 1088 Szent Janos Korhaz Es Eszak-Budai Egyesitett KorhazakBudapest, Hungary, 1125 Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz, Endoszkopos LaboratoriumGyula, Hungary, 5700 Clinfan Szolgaltato Kft.Szekszard, Hungary, 7100 Korea, Republic Of, Korea Kyungpook National University HospitalDaegu, Korea, Korea, Republic Of, 41944 Korea, Republic Of Kangbuk Samsung HospitalSeoul, Korea, Republic Of, 03181 Severance Hospital, Yonsei University Health SystemSeoul, Korea, Republic Of, 03722 The Catholic University Of Korea, Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591|Katowice, Poland, 40-659 Etg KielceKielce, Poland, 25-355 Indywidualna Specjalstyczna Praktyka Lekarska Maciej ZymlaKnurow, Poland, 44-190 Szpital W Knurowie Sp. Z O.O.Knurow, Poland, 44-190 Centrum Badan Klinicznych JciKrakow, Poland, 30-348 Marta Dagmara Banach Marta Banach Specjalistyczny Gabinet NeurologicznyKrakow, Poland, 30-539 Centrum Medyczne EvitaKrakow, Poland, 31-153 Szpital Specjalistyczny Im. Ludwika Rydygiera W Krakowie Sp. Z O.O.Krakow, Poland, 31-826 Ai Centrum Medyczne Sp. Z O.O. Sp.K.Poznan, Poland, 61-113 Endoskopia Sp. Z O. O.Sopot, Poland, 81-756 Szpital Sredzki Serca Jezusowego Sp. Z O.O.Sroda Wielkopolska, Poland, 63-000 Ez-Med Sp. Z O.O. Sp.K.Swidnica, Poland, 58-100 Gastromed Kopon, Zmudzinski I Wspolnicy Sp.J.Torun, Poland, 87-100 Centrum Zdrowia MdmWarszawa, Poland, 00-635 Centrum Diagnostyczno-Lecznicze Barska Sp. Z O. O.Wloclawek, Poland, 87-800 Centrum Gastrologiczno HepatologiczneWroclaw, Poland, 50-555 LexmedicaWroclaw, Poland, 53-114 Russian Federation Sechenov University On The Base Of Institute Of Translational Medicine And BiotechnologyMoscow, Russian Federation, 119435 Limited Liability Company \"Medical Center Sibnovomed\"Novosibirsk, Russian Federation, 630005 Federal State Budgetary Scientific Institution \"Scientific Research Institute Of Physiology AndNovosibirsk, Russian Federation, 630117 Clinic At Fsbei He \"Omsk State Medical University\" Moh RfOmsk, Russian Federation, 644050 Llc \"New Clinic\"Pyatigorsk, Russian Federation, 357500 Llc \"Riat\"Saint-Petersburg, Russian Federation, 195220 Saint-Petersburg State Budgetary Healthcare Institution \"City Hospital #26\"Saint-Petersburg, Russian Federation, 196247 Private Institution Educational Organization Of Higher EducationSamara, Russian Federation, 443011 Non-State Healthcare Institution 'Railway Clinical Hospital At Samara Station Of Open Joint StockSamara, Russian Federation, 443029 Saint-Petersburg State Budgetary Healthcare Institution \"City Clinical Hospital Of The RighteousSt. Petersburg, Russian Federation, 197706|Banska Bystrica, Slovakia, 975 17 Breznianske Centrum Gastroenterologie S.R.O.Brezno, Slovakia, 97701 Km Management Spol. S.R.O.Nitra, Slovakia, 949 01 Accout Center S.R.O. Gastroenterologicka AmbulanciaSahy, Slovakia, 936 01 Endomed, S.R.O.Vranov Nad Toplou, Slovakia, 093 01|Santander, Cantabria, Spain, 39008|Granada, Spain, 18014 Hospital Universitario Ramon Y CajalMadrid, Spain, 28034 Hospital Universitario Virgen Del RocioSevilla, Spain, 41013 Hospital Universitari I Politecnic La FeValencia, Spain, 46026|Ankara, Turkey, 06100 Ankara Universitesi Tip Fakultesi, Ibn-I Sina HastanesiAnkara, Turkey, 06100 Hacettepe Universitesi Tip Fakultesi, Ic Hastaliklari AnabilimAnkara, Turkey, 06230 Hacettepe Universitesi Tip FakultesiAnkara, Turkey, 06230 Bezmialem Vakif Universitesi Tip Fakultesi HastanesiIstanbul, Turkey, 34093 Istanbul Universitesi Cerrahpasa Tip FakultesiIstanbul, Turkey, 34098 Erciyes Universitesi Tip FakultesiKayseri, Turkey, 38039 Mersin Universitesi Tip Fakultesi Hastanesi, Ic HastaliklariMersin, Turkey, 33110 Mersin Universitesi Tip Fakultesi HastanesiMersin, Turkey, 33110 Karadeniz Teknik Universitesi Tip Fakultesi, Ic HastaliklariTrabzon, Turkey, 61080 Karadeniz Teknik Universitesi Tip FakultesiTrabzon, Turkey, 61080 Bulent Ecevit Universitesi Tip FakultesiZonguldak, Turkey, 67600|Chernivtsi, Ukraine, 58001 Regional Municipal Institution \"Chernivtsi Regional Clinical Hospital\", Surgery DepartmentChernivtsi, Ukraine, 58001 Traumatology And Orthopedic Center LlcChernivtsi, Ukraine, 58023 Private Enterprise Of Private Manufacturing Company \"Acinus\", Medical And Diagnostic CenterKropyvnytskyi, Ukraine, 25006 Kyiv Municipal Clinical Hospital #18, Proctology DepartmentKyiv, Ukraine, 01030 Medical Center \"Universal Clinic Oberig\" Of \"Kapital\" Llc, Gastro CenterKyiv, Ukraine, 03680 Lviv Clinical Hospital On Railway Transport Of Health Care Center Branch Of Pjsc Ukrainian RailwayLviv, Ukraine, 79007 Vinnytsia City Clinical Hospital No.1Vinnytsia, Ukraine, 21000 Private Small-Scale Enterprise Medical Center \"Pulse\"Vinnytsia, Ukraine, 21001 Vinnytsia Regional Clinical Hospital For War VeteransVinnytsia, Ukraine, 21005|Dothan, Alabama, United States, 36301 Gut P.C., Dba Digestive Health Specialists Of The SoutheastDothan, Alabama, United States, 36305|Beverly Hills, California, United States, 90210 Long Beach Clinical Trial Services, Inc.Long Beach, California, United States, 90806 Entertainment Medical GroupLos Angeles, California, United States, 90036 Gastrointestinal Biosciences Clinical Trials, LlcLos Angeles, California, United States, 90067 Alliance Clinical Research, LlcPoway, California, United States, 92064|Clearwater, Florida, United States, 33756-3839 West Coast Endoscopy CenterClearwater, Florida, United States, 33756 Gastro FloridaClearwater, Florida, United States, 33762 Millenia Surgery CenterOrlando, Florida, United States, 32811 Hmd Research LlcOrlando, Florida, United States, 32819 Orlando Gastroenterology, PaOrlando, Florida, United States, 32835|Houma, Louisiana, United States, 70360 Gulf Coast Surgical CenterHouma, Louisiana, United States, 70360 The Hearing Center (Audiology)Houma, Louisiana, United States, 70360|Chevy Chase, Maryland, United States, 20815 Mgg Group Co., Inc., Chevy Chase Clinical ResearchChevy Chase, Maryland, United States, 20815|Boston, Massachusetts, United States, 02115 Mass Eye And Ear, LongwoodBoston, Massachusetts, United States, 02115 Brigham And Women'S HospitalChestnut Hill, Massachusetts, United States, 02467 Umass Memorial Medical CenterWorcester, Massachusetts, United States, 01655 University Of Massachusetts Medical SchoolWorcester, Massachusetts, United States, 01655|Chesterfield, Michigan, United States, 48047 Eastside Endoscopy CenterMacomb, Michigan, United States, 48044|New York, New York, United States, 10021 New York Presbyterian Hospital - Weill Cornell Medical College (Colonoscopy)New York, New York, United States, 10065 New York Presbyterian Hospital - Weill Cornell Medical College Investigational PharmacyNew York, New York, United States, 10065 Weill Cornell Medical College - New York Presbyterian Hospital (Endoscopy Suite)New York, New York, United States, 10065 Weill Cornell Medical College - New York Presbyterian HospitalNew York, New York, United States, 10065 Digiovanna Institute For Medical Education & ResearchNorth Massapequa, New York, United States, 11758-1802|Chapel Hill, North Carolina, United States, 27514 Unc Hospitals Endoscopy Center At MeadowmontChapel Hill, North Carolina, United States, 27517 University Of North Carolina At Chapel HillChapel Hill, North Carolina, United States, 27599 Gastroenterology Associates Of The Piedmont, PaWinston-Salem, North Carolina, United States, 27103 Pmg Research Of Winston-Salem, LlcWinston-Salem, North Carolina, United States, 27103|Kingsport, Tennessee, United States, 37660 Holston Medical GroupKingsport, Tennessee, United States, 37660 Holston Valley Surgery Center (Testing Only)Kingsport, Tennessee, United States, 37660|Arlington, Texas, United States, 76012 Envision Imaging (Cxr)Arlington, Texas, United States, 76012 Texas Clinical Research Institiute, LlcArlington, Texas, United States, 76012 Hermann Drive Surgical HospitalHouston, Texas, United States, 77004 Pearland Surgery CenterHouston, Texas, United States, 77047 Gulf Coast Research Group, LlcHouston, Texas, United States, 77098 North Texas Research AssociatesMckinney, Texas, United States, 75069 Lonestar Endoscopy, LlpSouthlake, Texas, United States, 76092 Texas Digestive Disease ConsultantsSouthlake, Texas, United States, 76092|Fairfax, Virginia, United States, 22031","Alabama|California|Florida|Louisiana|Maryland|Massachusetts|Michigan|New York|North Carolina|Tennessee|Texas|Virginia","Australia|Belgium|Croatia|Georgia|Hungary|Poland|Slovakia|Spain|Turkey|Ukraine|United States","New South Wales Concord Repatriation General Hospital|Saint John Of God Subiaco Hospital|Victoria Ballarat Base Hospital|University Hospital Brussels|Opca Bolnica Zadar, Odjel Za Gastroenterologiju|The First University Clinic Of Tsmu|Bekes Megyei Kozponti Korhaz, Rethy Pal Tagkorhaz|Niepubliczny Zaklad Opieki Zdrowotnej All-Medicus|Fakultna Nemocnica S Poliklinikou F.D. Roosevelta Banska Bystrica|Cantabria Hospital Universitario Marques De Valdecilla|Hospital Universitario Virgen De Las Nieves De Granada|Ankara Universitesi Tip Fakultesi, Ibn-I Sina Hastanesi, Ic Hastaliklari Anabilim Dali,|Regional Municipal Institution \"Chernivtsi Regional Clinical Hospital\", Gastroenterology Department,|Dothan Surgery Center|Brighton Surgical Center|Gastro Florida|Cronola, Llc|Chevy Chase Endoscopy Center|Brigham And Women's Hospital|Clinical Research Institute Of Michigan, Llc|Weill Cornell Medical College (Clinical Site)|Unc Hospitals|Holston Medical Group (Drug Shipment Only)|Cross Timbers Surgery Center L.P. (Colonoscopy)|Verity Research, Inc.",{"$nulls":3},"Pfizer CT.gov Call Center","2018-09-24","2020-05-25T16:36:03.639","2020-05-26T17:10:42.972","NCT03395184"]
["5ecbf3f3e2561b1b11905d05","NCT03395184","2018-10-31","Pfizer","PFE","Recruiting","Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PFâ€‘06700841 In Subjects With Moderate To Severe Crohn's Disease","Brepocitinib|Pf-06651600","JAK1 Inhibitor|TYK2 Inhibitor|JAK1 Inhibitor|JAK3 Inhibitor","Yes","['Brepocitinib', 'Pf-06651600']","Yes","['TYK2 Inhibitor', 'JAK3 Inhibitor']","Phase 2",2,250,"Anticipated","2018-02-02","2020-02-04","DAS","Disease Activity Score",{"$nulls":3},"The objectives of this study are to evaluate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-06651600 (200 mg for 8 weeks followed by 50 mg for 4 weeks) dosed once daily and PF-06700841 (60 mg for 12 weeks) dosed once daily during an induction period of 12 weeks, followed by an open label extension period at doses of 50 mg and 30 mg of PF 06651600 and PF 06700841, respectively, for 52 weeks.",null,"A PHASE 2A, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ORAL PF-06651600 AND PF-06700841 AS INDUCTION AND OPEN LABEL EXTENSION TREATMENT IN SUBJECTS WITH MODERATE TO SEVERE CROHN'S DISEASE","B7981007","Crohn's Disease","Crohn Disease","Gastrointestinal Diseases","Gastrointestinal","Experimental","PF-06700841 or placebo|PF-06651600 or placebo",null,"Drug","Placebo PF-06700841|PF-06700841|Placebo PF-06651600|PF-06651600","12 weeks, followed by PF-06700841, 30 mg QD for 52 weeks.|60 mg QD for 12 weeks followed by 30 mg QD for up to 52 weeks|12 weeks, followed by PF-06651600, 50 mg QD for 52 weeks|200 mg QD for 8 weeks, followed by 50 mg QD up to 56 weeks",null,"PF-06700841 or placebo|PF-06651600 or placebo","\n\n 1. Male and/or female subjects 18 years to 75 years of age\n 2. Documented diagnosis of ileal, ileocolonic, or colonic CD with a minimum disease duration of 3 months, as determined by endoscopic and histopathology assessment.\n 3. Endoscopic confirmation of active disease with total SES CD total score of at least 7. For isolated ileal disease, SES CD total score should be at least 4.\n 4. An average daily liquid/soft stool frequency (SF) greater than or equal to 2.5 or daily abdominal pain (AP) greater than or equal to 2.0.\n 5. Must have inadequate response to, loss of response to, or intolerance to at least one conventional therapy for CD:â€¢Steroids; Immunosuppressants (azathioprine [AZA], 6 MP, or methotrexate [MTX]); Anti TNF inhibitors (infliximab, adalimumab,certolizumab); Anti integrin inhibitors (eg, vedolizumab); Anti IL 12/23 inhibitor (ustekinumab).\n    \n    \n 6. Subjects currently receiving the following treatment for CD are eligible providing they have been on stable doses as described below: * Oral corticosteroids (prednisone or equivalent up to 25 mg/day; budesonide up to 9 mg/day). Stable dose for at least 2 weeks prior to baseline. If oral corticosteroids have been recently discontinued, they must have been stopped at least 2 weeks prior to baseline. Decreases in steroid use due to AEs are allowed.\n     * Oral 5 ASA or sulfasalazine are allowed providing that the dose is stable for at least 4 weeks prior to baseline.\n     * Crohn's disease related antibiotics are allowed providing that the dose is stable for at least 4 weeks prior to baseline. If antibiotics are stopped prior to baseline, they must be discontinued at least 4 days prior to baseline.\n    \n    \n\n","\n\n 1.  Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, diverticular disease, ulcerative colitis (UC), or clinical findings suggestive of UC.\n 2.  Presence of active (draining) fistulae or intra abdominal or perineal abscesses.\n 3.  Strictures with obstructive symptoms.\n 4.  Short bowel syndrome.\n 5.  History of bowel perforation requiring surgical intervention within the past 12 months.\n 6.  Previous bowel surgery resulting in an existing stoma. Subjects who have a j pouch are excluded, as a j pouch can result in a stoma.\n 7.  History of bowel surgery within 6 months prior to baseline.\n 8.  Subjects displaying clinical signs of fulminant colitis or toxic megacolon.\n 9.  Subjects with primary sclerosing cholangitis.\n 10. Subjects with evidence of colonic adenomas, dysplasia or neoplasia.\n 11. Abnormal findings on the chest x ray film such as presence of tuberculosis (TB), general infections, heart failure, or malignancy.\n 12. Any history of either untreated or inadequately treated latent or active TB infection, current treatment for active or latent TB infection or evidence of currently active TB by chest x ray, residing with or frequent close contact with individual(s) with active TB.\n 13. Subjects receiving the following therapies within the time period described below or expected to receive any of these therapies during the study period: 1.  >9 mg/day of oral budesonide or >25 mg/day of prednisone or equivalent oral systemic corticosteroid dose within 2 weeks prior to baseline.\n      2.  IV, IM (parenteral), or topical (rectal) treatment of 5 ASA or corticosteroid enemas/suppositories within 2 weeks prior to baseline.\n      3.  Azathioprine, 6 mercaptopurine, or methotrexate within 2 weeks prior to baseline.\n      4.  Anti TNF inhibitors (or biosimilars thereof) as described below: * Infliximab within 8 weeks prior to baseline;\n           * Adalimumab within 8 weeks prior to baseline;\n           * Certolizumab within 8 weeks prior to baseline;\n          \n          \n      5.  Anti integrin inhibitors (eg, vedolizumab) within 8 weeks prior to baseline.\n      6.  Ustekinumab within 8 weeks prior to baseline.\n      7.  Interferon therapy within 8 weeks prior to baseline.\n      8.  Subjects with prior treatment with lymphocyte depleting agents/therapies within 1 year prior to baseline (eg, CamPath[alemtuzumab], alkylating agents [eg, cyclophosphamide or chlorambucil], total lymphoid irradiation, etc).\n      9.  Subjects who have received rituximab or other selective B lymphocyte depleting agents within 1 year prior to baseline.\n      10. Subjects previously receiving leukocyte apheresis, including selective lymphocyte, monocyte, or granulocyte apheresis, or plasma exchange within 6 months prior to baseline.\n      11. Other marketed immunosuppressants or biologics with immunomodulatory properties within 3 months prior to baseline.\n      12. Subjects who have received other JAK inhibitors within 3 months prior to baseline.\n      13. Subjects who have not responded to or have been intolerant of other JAK inhibitors.\n      14. Other investigational procedures(s) or product(s), such as immunosuppressants used in transplantation (eg, mycophenolate mofetil, cyclosporine, rapamycin, or tacrolimus) or live (attenuated) vaccine within 30 days prior to baseline.","TNF","tumor necrosis factor","Protein","Lung, Breast, Ovary","Actual","2018-01-10","Actual","Anticipated","2021-02-18","Anticipated","2018-10-01","2017-12-05","2018-01-03","2018-10-30","Yes",null,"Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years","75 Years","All",null,"No","Yes\nInformation relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests",null,"URL: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7981007&StudyName=A+Phase+2a%2C+Double-blind%2C+Randomized%2C+Placebo-controlled%2C+Parallel+Group+Study+To+Evaluate+The+Efficacy+And+Safety+Of+Oral+Pf-06651600+And+Pf-06700841+As+Induction+And+Open+Label+Extension+Treatment+In+Subjects+With+Moderate+To+Severe+Crohn%E2%80%99s+Disease [https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7981007&StudyName=A+Phase+2a%2C+Double-blind%2C+Randomized%2C+Placebo-controlled%2C+Parallel+Group+Study+To+Evaluate+The+Efficacy+And+Safety+Of+Oral+Pf-06651600+And+Pf-06700841+As+Induction+And+Open+Label+Extension+Treatment+In+Subjects+With+Moderate+To+Severe+Crohn%E2%80%99s+Disease] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To obtain contact information for a study center near you, click here.",null,"Yes","No",{"$nulls":17},"2017-003359-43|PIZZICATO","EudraCT Number|Alias Study Number","Proportion of subjects achieving clinically meaningful endoscopic improvement (reduction of more than or equal to 3 points from baseline in Simplified Endoscopic Activity Score for Crohn's Disease (SES-CD) at Week 12","12 weeks",null,"Number of participants with potentially clinically important serious infections findings|Mean change from baseline in SES-CD score at Week 12.|Proportion of subjects achieving SES-CD 25 and SES-CD 50 at Week 12.|Proportion of subjects achieving endoscopic remission (SES-CD less than or equal to 2) at Week 12.|Proportion of subjects achieving mucosal healing at Week 12.|Number of subjects with adverse events|Number of subjects with serious adverse events|Number of subjects with electrocardiogram findings of potential clinical importance.|Number of subjects withdrawal due to adverse events|Number of subjects with vital signs findings of potential clinical importance.|Number of subjects with laboratory tests findings of potential clinical importance.|Proportion of subjects achieving SES CD 25 and SES CD 50 at Week 64 among subjects who achieved SES CD 25 and SES CD 50 at week 12 respectively.|Proportion of subjects achieving clinically meaningful endoscopic improvement (CMEI response) at week 64 among subjects who achieved CMEI response at Week 12.","64 weeks|Baseline, week 12|Number of subjects achieving SES-CD 25 and SES-CD 50 at Week 12.|Number of subjects achieving endoscopic remission (SES-CD less than or equal to 2) at Week 12.|Number of subjects achieving mucosal healing at Week 12.|Number of participants with reported adverse events|Number of participants with reported serious adverse events|Number of participants with potentially clinically important electrocardiogram findings.|Number of subjects withdrawal due to adverse events.|Number of participants with potentially clinically important vital signs findings.|Number of participants with potentially clinically important laboratory findings.|Number of subjects achieving SES-CD 25 and SES-CD 50 at Week 64 among subjects who achieved SES CD 25 and SES CD 50 at week 12|Number of subject achieving clinically meaningful endoscopic improvement (CMEI response) at week 64 among subjects who achieved CMEI response at week 12.","Baseline, week 12|Week 12|Baseline up to 64 weeks|Baseline u to 64 weeks|week 64","ClinicalTrials.gov_Inquiries@pfizer.com","Pfizer CT.gov Call Center","1-800-718-1021","Concord, New South Wales, Australia, 2139|Subiaco, Western|Ballarat, Victoria, Australia, 3350|Jette, Belgium, 1090 University Hospitals LeuvenLeuven, Belgium, 3000 Chc - Saint-JosephLiÃ¨ge, Belgium, 4000|Winnipeg, Manitoba, Canada, R3A 1R9|Zagreb, Hrvatska, Croatia, 10000|Rijeka, Croatia, 51000 Opca Bolnica Zadar, Odjel Za GastroenterologijuZadar, Croatia, 23000 Klinicka Bolnica Dubrava ZagrebZagreb, Croatia, 10000|Bilina, Czechia, 41801 Medialpharma S.R.O.Hradec Kralove, Czechia, 500 12 Hepato-Gastroenterology Hk S.R.O.Hradec Kralove, Czechia, 50012 Gastroenterologicka Ambulance A EndoskopieMost, Czechia, 43401 Artroscan, S.R.O., Gastroenterologicke OddeleniOstrava, Czechia, 722 00 Lekarna U VitkaOstrava, Czechia, 722 00 Nemocnice Strakonice, A.S., Interni OddeleniStrakonice, Czechia, 386 01 Nemocnice Strakonice, A.S.Strakonice, Czechia, 386 29|Tbilisi, Georgia, 0141 David Tatishvili Medical CenterTbilisi, Georgia, 0186|Bekescsaba, Hungary, 5600 Semmelweis Egyetem, Ii. Belgyogyaszati KlinikaBudapest, Hungary, 1088 Szent Janos Korhaz Es Eszak-Budai Egyesitett KorhazakBudapest, Hungary, 1125 Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz, Endoszkopos LaboratoriumGyula, Hungary, 5700 Clinfan Szolgaltato Kft.Szekszard, Hungary, 7100 Csolnoky Ferenc Korhaz Belgyogyaszati Centrum I. Belgyogyaszati OsztalyVeszprem, Hungary, 8200|Messina, Italy, 98125 Istituto Clinico Humanitas Irccs - Ibd CenterMilan, Italy, 20089 Policlinico Gemelli/Complesso Integrato ColumbusRome, Italy, 00168 Korea, Republic Of, Korea Kyungpook National University HospitalDaegu, Korea, Korea, Republic Of, 41944 Korea, Republic Of Kangbuk Samsung HospitalSeoul, Korea, Republic Of, 03181 Severance Hospital, Yonsei University Health SystemSeoul, Korea, Republic Of, 03722 The Catholic University Of Korea, Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591|Catanzaro, Cz, Italy, 88100|Katowice, Poland, 40-659 Etg KielceKielce, Poland, 25-355 Indywidualna Specjalstyczna Praktyka Lekarska Maciej ZymlaKnurow, Poland, 44-190 Szpital W Knurowie Sp. Z O.O.Knurow, Poland, 44-190 Centrum Badan Klinicznych JciKrakow, Poland, 30-348 Marta Dagmara Banach Marta Banach Specjalistyczny Gabinet NeurologicznyKrakow, Poland, 30-539 Centrum Medyczne EvitaKrakow, Poland, 31-153 Szpital Specjalistyczny Im. Ludwika Rydygiera W Krakowie Sp. Z O.O.Krakow, Poland, 31-826 Medical Magnus ClinicLodz, Poland, 90-552 Wojewodzki Szpital Specjalistyczny Im. Bieganskiego W LodziLodz, Poland, 91-347 Gastromed Sp. Z O.O.Lublin, Poland, 20-582 Ai Centrum Medyczne Sp. Z O.O. Sp.K.Poznan, Poland, 61-113 Korczowski Bartosz Gabinet LekarskiRzeszow, Poland, 35-302 Endoskopia Sp. Z O. O.Sopot, Poland, 81-756 Szpital Sredzki Serca Jezusowego Sp. Z O.O.Sroda Wielkopolska, Poland, 63-000 Ez-Med Sp. Z O.O. Sp.K.Swidnica, Poland, 58-100 Gastromed Kopon, Zmudzinski I Wspolnicy Sp.J.Torun, Poland, 87-100 Centrum Zdrowia MdmWarszawa, Poland, 00-635 Centrum Diagnostyczno-Lecznicze Barska Sp. Z O. O.Wloclawek, Poland, 87-800 Centrum Gastrologiczno HepatologiczneWroclaw, Poland, 50-555 LexmedicaWroclaw, Poland, 53-114 Russian Federation Llc \"Alliance Biomedical-Ural Group\"Izhevsk, Russian Federation, 426061 Clinic Of Fsbei He Ksmu Moh RfKrasnodar, Russian Federation, 350072 Llc \"Olla-Med\"Moscow, Russian Federation, 105554 Sechenov University On The Base Of Institute Of Translational Medicine And BiotechnologyMoscow, Russian Federation, 119435 Limited Liability Company \"Medical Center Sibnovomed\"Novosibirsk, Russian Federation, 630005 Federal State Budgetary Scientific Institution \"Scientific Research Institute Of Physiology AndNovosibirsk, Russian Federation, 630117 Clinic At Fsbei He \"Omsk State Medical University\" Moh RfOmsk, Russian Federation, 644050 Llc \"New Clinic\"Pyatigorsk, Russian Federation, 357500 Limited Liability Company \"Riat\"Saint-Petersburg, Russian Federation, 195220 Saint-Petersburg State Budgetary Healthcare Institution \"City Hospital #26\"Saint-Petersburg, Russian Federation, 196247 Private Institution Educational Organization Of Higher EducationSamara, Russian Federation, 443011 Non-State Healthcare Institution 'Railway Clinical Hospital At Samara Station Of Open Joint StockSamara, Russian Federation, 443029 Saint-Petersburg State Budgetary Healthcare Institution \"City Clinical Hospital Of The RighteousSt. Petersburg, Russian Federation, 197706|Kragujevac, Srbija, Serbia, 34000 Klinicki Centar NisNis, Srbija, Serbia, 18000|Banska Bystrica, Slovakia, 975 17 Breznianske Centrum Gastroenterologie S.R.O.Brezno, Slovakia, 97701 Km Management Spol. S.R.O.Nitra, Slovakia, 949 01 Accout Center S.R.O. Gastroenterologicka AmbulanciaSahy, Slovakia, 936 01 Endomed, S.R.O.Vranov Nad Toplou, Slovakia, 093 01|Santander, Cantabria, Spain, 39008|Granada, Spain, 18014 Hospital Universitario Ramon Y CajalMadrid, Spain, 28034 Hospital Universitario Virgen Del RocioSevilla, Spain, 41013 Hospital Universitari I Politecnic La FeValencia, Spain, 46026|Ankara, Turkey, 06100 Ankara Universitesi Tip Fakultesi, Ibn-I Sina HastanesiAnkara, Turkey, 06100 Hacettepe Universitesi Tip Fakultesi, Ic Hastaliklari AnabilimAnkara, Turkey, 06230 Hacettepe Universitesi Tip FakultesiAnkara, Turkey, 06230 Bezmialem Vakif Universitesi Tip Fakultesi HastanesiIstanbul, Turkey, 34093 Istanbul Universitesi Cerrahpasa Tip FacultesiIstanbul, Turkey, 34098 Istanbul Universitesi Cerrahpasa Tip FakultesiIstanbul, Turkey, 34098 Erciyes Universitesi Tip FakultesiKayseri, Turkey, 38039 Mersin Universitesi Tip Fakultesi Hastanesi, Ic HastaliklariMersin, Turkey, 33110 Mersin Universitesi Tip Fakultesi HastanesiMersin, Turkey, 33110 Karadeniz Teknik Universitesi Tip Fakultesi, Ic HastaliklariTrabzon, Turkey, 61080 Karadeniz Teknik Universitesi Tip FakultesiTrabzon, Turkey, 61080 Bulent Ecevit Universitesi Tip FakultesiZonguldak, Turkey, 67600|Chernivtsi, Ukraine, 58001 Regional Municipal Institution \"Chernivtsi Regional Clinical Hospital\", Surgery DepartmentChernivtsi, Ukraine, 58001 Traumatology And Orthopedic Center LlcChernivtsi, Ukraine, 58023 Municipal Healthcare Institution Kharkiv City Clinical Hospital #2 N.A. Prof. O.O. ShalimovKharkiv, Ukraine, 61037 Private Enterprise Of Private Manufacturing Company \"Acinus\", Medical And Diagnostic CenterKropyvnytskyi, Ukraine, 25006 Kyiv Municipal Clinical Hospital #18, Proctology DepartmentKyiv, Ukraine, 01030 Medical Center \"Universal Clinic Oberig\" Of \"Kapital\" Llc, Gastro CenterKyiv, Ukraine, 03680 Lviv Clinical Hospital On Railway Transport Of Health Care Center Branch Of Pjsc Ukrainian RailwayLviv, Ukraine, 79007 Vinnytsia City Clinical Hospital No.1Vinnytsia, Ukraine, 21000 Private Small-Scale Enterprise Medical Center \"Pulse\"Vinnytsia, Ukraine, 21001 Vinnytsia Regional Clinical Hospital For War VeteransVinnytsia, Ukraine, 21005 Vinnytsia Regional Clinical Hospital N.A. M.I.PyrohovVinnytsia, Ukraine, 21018|Dothan, Alabama, United States, 36301 Gut P.C., Dba Digestive Health Specialists Of The SoutheastDothan, Alabama, United States, 36305|Beverly Hills, California, United States, 90210 Long Beach Clinical Trial Services, Inc.Long Beach, California, United States, 90806 Entertainment Medical GroupLos Angeles, California, United States, 90036 Gastrointestinal Biosciences Clinical Trials, LlcLos Angeles, California, United States, 90067 Alliance Clinical Research, LlcPoway, California, United States, 92064|Clearwater, Florida, United States, 33756-3839 West Coast Endoscopy CenterClearwater, Florida, United States, 33756 Gastro FloridaClearwater, Florida, United States, 33762 Millenia Surgery CenterOrlando, Florida, United States, 32811 Hmd Research LlcOrlando, Florida, United States, 32819 Orlando Gastroenterology, PaOrlando, Florida, United States, 32835|Shawnee Mission, Kansas, United States, 66217|Houma, Louisiana, United States, 70360 Gulf Coast Surgical CenterHouma, Louisiana, United States, 70360 The Hearing Center (Audiology)Houma, Louisiana, United States, 70360|Chevy Chase, Maryland, United States, 20815 Mgg Group Co., Inc., Chevy Chase Clinical ResearchChevy Chase, Maryland, United States, 20815|Boston, Massachusetts, United States, 02115 Mass Eye And Ear, LongwoodBoston, Massachusetts, United States, 02115 Brigham And Women'S HospitalChestnut Hill, Massachusetts, United States, 02467 Umass Memorial Medical CenterWorcester, Massachusetts, United States, 01655 University Of Massachusetts Medical SchoolWorcester, Massachusetts, United States, 01655|Chesterfield, Michigan, United States, 48047 Eastside Endoscopy CenterMacomb, Michigan, United States, 48044|New York, New York, United States, 10021 New York Presbyterian Hospital - Weill Cornell Medical College (Colonoscopy)New York, New York, United States, 10065 New York Presbyterian Hospital - Weill Cornell Medical College Investigational PharmacyNew York, New York, United States, 10065 Weill Cornell Medical College - New York Presbyterian Hospital (Endoscopy Suite)New York, New York, United States, 10065 Weill Cornell Medical College - New York Presbyterian HospitalNew York, New York, United States, 10065 Digiovanna Institute For Medical Education & ResearchNorth Massapequa, New York, United States, 11758-1802|Chapel Hill, North Carolina, United States, 27514 Unc Hospitals Endoscopy Center At MeadowmontChapel Hill, North Carolina, United States, 27517 University Of North Carolina At Chapel HillChapel Hill, North Carolina, United States, 27599 Gastroenterology Associates Of The Piedmont, PaWinston-Salem, North Carolina, United States, 27103 Pmg Research Of Winston-Salem, LlcWinston-Salem, North Carolina, United States, 27103|Kingsport, Tennessee, United States, 37660 Holston Medical GroupKingsport, Tennessee, United States, 37660 Holston Valley Surgery Center (Testing Only)Kingsport, Tennessee, United States, 37660|Arlington, Texas, United States, 76012 Envision Imaging (Cxr)Arlington, Texas, United States, 76012 Texas Clinical Research Institiute, LlcArlington, Texas, United States, 76012 Hermann Drive Surgical HospitalHouston, Texas, United States, 77004 Pearland Surgery CenterHouston, Texas, United States, 77047 Gulf Coast Research Group, LlcHouston, Texas, United States, 77098 North Texas Research AssociatesMckinney, Texas, United States, 75069 Lonestar Endoscopy, LlpSouthlake, Texas, United States, 76092 Texas Digestive Disease ConsultantsSouthlake, Texas, United States, 76092|Fairfax, Virginia, United States, 22031","Alabama|California|Florida|Kansas|Louisiana|Maryland|Massachusetts|Michigan|New York|North Carolina|Tennessee|Texas|Virginia","Australia|Belgium|Canada|Croatia|Czechia|Georgia|Hungary|Italy|Poland|Serbia|Slovakia|Spain|Turkey|Ukraine|United States","New South Wales Concord Repatriation General Hospital|Saint John Of God Subiaco Hospital|Victoria Ballarat Base Hospital|University Hospital Brussels|Manitoba Winnipeg Regional Health Authority - Health Sciences Centre, Winnipeg|Hrvatska Klinicki Bolnicki Centar Sestre Milosrdnice|Klinicki Bolnicki Centar Rijeka, Odjel Za Gastroenterologiju|Lekarna Altea|The First University Clinic Of Tsmu|Bekes Megyei Kozponti Korhaz, Rethy Pal Tagkorhaz|A.O.U. Policlinico G. Martino|Cz Univ. \"Magna Graecia\" Di Catanzaro|Niepubliczny Zaklad Opieki Zdrowotnej All-Medicus|Srbija Klinicki Centar Kragujevac|Fakultna Nemocnica S Poliklinikou F.D. Roosevelta Banska Bystrica|Cantabria Hospital Universitario Marques De Valdecilla|Hospital Universitario Virgen De Las Nieves De Granada|Ankara Universitesi Tip Fakultesi, Ibn-I Sina Hastanesi, Ic Hastaliklari Anabilim Dali,|Regional Municipal Institution \"Chernivtsi Regional Clinical Hospital\", Gastroenterology Department,|Dothan Surgery Center|Brighton Surgical Center|Gastro Florida|Westglen Gastrointestinal Consultants, P.A.|Cronola, Llc|Chevy Chase Endoscopy Center|Brigham And Women's Hospital|Clinical Research Institute Of Michigan, Llc|Weill Cornell Medical College (Clinical Site)|Unc Hospitals|Holston Medical Group (Drug Shipment Only)|Cross Timbers Surgery Center L.P. (Colonoscopy)|Verity Research, Inc.",{"$nulls":3},"Pfizer CT.gov Call Center","2018-10-30","2020-05-25T16:36:03.269","2020-05-26T17:10:42.972","NCT03395184"]
["5ecbf3f3e2561b1b11905d06","NCT03395184","2018-11-19","Pfizer","PFE","Recruiting","Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PFâ€‘06700841 In Subjects With Moderate To Severe Crohn's Disease","Brepocitinib|Pf-06651600","JAK1 Inhibitor|TYK2 Inhibitor|JAK1 Inhibitor|JAK3 Inhibitor","Yes","['Brepocitinib', 'Pf-06651600']","Yes","['TYK2 Inhibitor', 'JAK3 Inhibitor']","Phase 2",2,250,"Anticipated","2018-02-02","2020-02-04","DAS","Disease Activity Score",{"$nulls":3},"The objectives of this study are to evaluate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-06651600 (200 mg for 8 weeks followed by 50 mg for 4 weeks) dosed once daily and PF-06700841 (60 mg for 12 weeks) dosed once daily during an induction period of 12 weeks, followed by an open label extension period at doses of 50 mg and 30 mg of PF 06651600 and PF 06700841, respectively, for 52 weeks.",null,"A PHASE 2A, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ORAL PF-06651600 AND PF-06700841 AS INDUCTION AND OPEN LABEL EXTENSION TREATMENT IN SUBJECTS WITH MODERATE TO SEVERE CROHN'S DISEASE","B7981007","Crohn's Disease","Crohn Disease","Gastrointestinal Diseases","Gastrointestinal","Experimental","PF-06700841 or placebo|PF-06651600 or placebo",null,"Drug","Placebo PF-06700841|PF-06700841|Placebo PF-06651600|PF-06651600","12 weeks, followed by PF-06700841, 30 mg QD for 52 weeks.|60 mg QD for 12 weeks followed by 30 mg QD for up to 52 weeks|12 weeks, followed by PF-06651600, 50 mg QD for 52 weeks|200 mg QD for 8 weeks, followed by 50 mg QD up to 56 weeks",null,"PF-06700841 or placebo|PF-06651600 or placebo","\n\n 1. Male and/or female subjects 18 years to 75 years of age\n 2. Documented diagnosis of ileal, ileocolonic, or colonic CD with a minimum disease duration of 3 months, as determined by endoscopic and histopathology assessment.\n 3. Endoscopic confirmation of active disease with total SES CD total score of at least 7. For isolated ileal disease, SES CD total score should be at least 4.\n 4. An average daily liquid/soft stool frequency (SF) greater than or equal to 2.5 or daily abdominal pain (AP) greater than or equal to 2.0.\n 5. Must have inadequate response to, loss of response to, or intolerance to at least one conventional therapy for CD:â€¢Steroids; Immunosuppressants (azathioprine [AZA], 6 MP, or methotrexate [MTX]); Anti TNF inhibitors (infliximab, adalimumab,certolizumab); Anti integrin inhibitors (eg, vedolizumab); Anti IL 12/23 inhibitor (ustekinumab).\n    \n    \n 6. Subjects currently receiving the following treatment for CD are eligible providing they have been on stable doses as described below: * Oral corticosteroids (prednisone or equivalent up to 25 mg/day; budesonide up to 9 mg/day). Stable dose for at least 2 weeks prior to baseline. If oral corticosteroids have been recently discontinued, they must have been stopped at least 2 weeks prior to baseline. Decreases in steroid use due to AEs are allowed.\n     * Oral 5 ASA or sulfasalazine are allowed providing that the dose is stable for at least 4 weeks prior to baseline.\n     * Crohn's disease related antibiotics are allowed providing that the dose is stable for at least 4 weeks prior to baseline. If antibiotics are stopped prior to baseline, they must be discontinued at least 4 days prior to baseline.\n    \n    \n\n","\n\n 1.  Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, diverticular disease, ulcerative colitis (UC), or clinical findings suggestive of UC.\n 2.  Presence of active (draining) fistulae or intra abdominal or perineal abscesses.\n 3.  Strictures with obstructive symptoms.\n 4.  Short bowel syndrome.\n 5.  History of bowel perforation requiring surgical intervention within the past 12 months.\n 6.  Previous bowel surgery resulting in an existing stoma. Subjects who have a j pouch are excluded, as a j pouch can result in a stoma.\n 7.  History of bowel surgery within 6 months prior to baseline.\n 8.  Subjects displaying clinical signs of fulminant colitis or toxic megacolon.\n 9.  Subjects with primary sclerosing cholangitis.\n 10. Subjects with evidence of colonic adenomas, dysplasia or neoplasia.\n 11. Abnormal findings on the chest x ray film such as presence of tuberculosis (TB), general infections, heart failure, or malignancy.\n 12. Any history of either untreated or inadequately treated latent or active TB infection, current treatment for active or latent TB infection or evidence of currently active TB by chest x ray, residing with or frequent close contact with individual(s) with active TB.\n 13. Subjects receiving the following therapies within the time period described below or expected to receive any of these therapies during the study period: 1.  >9 mg/day of oral budesonide or >25 mg/day of prednisone or equivalent oral systemic corticosteroid dose within 2 weeks prior to baseline.\n      2.  IV, IM (parenteral), or topical (rectal) treatment of 5 ASA or corticosteroid enemas/suppositories within 2 weeks prior to baseline.\n      3.  Azathioprine, 6 mercaptopurine, or methotrexate within 2 weeks prior to baseline.\n      4.  Anti TNF inhibitors (or biosimilars thereof) as described below: * Infliximab within 8 weeks prior to baseline;\n           * Adalimumab within 8 weeks prior to baseline;\n           * Certolizumab within 8 weeks prior to baseline;\n          \n          \n      5.  Anti integrin inhibitors (eg, vedolizumab) within 8 weeks prior to baseline.\n      6.  Ustekinumab within 8 weeks prior to baseline.\n      7.  Interferon therapy within 8 weeks prior to baseline.\n      8.  Subjects with prior treatment with lymphocyte depleting agents/therapies within 1 year prior to baseline (eg, CamPath[alemtuzumab], alkylating agents [eg, cyclophosphamide or chlorambucil], total lymphoid irradiation, etc).\n      9.  Subjects who have received rituximab or other selective B lymphocyte depleting agents within 1 year prior to baseline.\n      10. Subjects previously receiving leukocyte apheresis, including selective lymphocyte, monocyte, or granulocyte apheresis, or plasma exchange within 6 months prior to baseline.\n      11. Other marketed immunosuppressants or biologics with immunomodulatory properties within 3 months prior to baseline.\n      12. Subjects who have received other JAK inhibitors within 3 months prior to baseline.\n      13. Subjects who have not responded to or have been intolerant of other JAK inhibitors.\n      14. Other investigational procedures(s) or product(s), such as immunosuppressants used in transplantation (eg, mycophenolate mofetil, cyclosporine, rapamycin, or tacrolimus) or live (attenuated) vaccine within 30 days prior to baseline.","TNF","tumor necrosis factor","Protein","Lung, Breast, Ovary","Actual","2018-01-10","Actual","Anticipated","2021-02-18","Anticipated","2018-11-01","2017-12-05","2018-01-03","2018-11-16","Yes",null,"Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years","75 Years","All",null,"No","Yes\nInformation relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests",null,"URL: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7981007&StudyName=A+Phase+2a%2C+Double-blind%2C+Randomized%2C+Placebo-controlled%2C+Parallel+Group+Study+To+Evaluate+The+Efficacy+And+Safety+Of+Oral+Pf-06651600+And+Pf-06700841+As+Induction+And+Open+Label+Extension+Treatment+In+Subjects+With+Moderate+To+Severe+Crohn%E2%80%99s+Disease [https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7981007&StudyName=A+Phase+2a%2C+Double-blind%2C+Randomized%2C+Placebo-controlled%2C+Parallel+Group+Study+To+Evaluate+The+Efficacy+And+Safety+Of+Oral+Pf-06651600+And+Pf-06700841+As+Induction+And+Open+Label+Extension+Treatment+In+Subjects+With+Moderate+To+Severe+Crohn%E2%80%99s+Disease] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To obtain contact information for a study center near you, click here.",null,"Yes","No",{"$nulls":17},"2017-003359-43|PIZZICATO","EudraCT Number|Alias Study Number","Proportion of subjects achieving clinically meaningful endoscopic improvement (reduction of more than or equal to 3 points from baseline in Simplified Endoscopic Activity Score for Crohn's Disease (SES-CD) at Week 12","12 weeks",null,"Number of participants with potentially clinically important serious infections findings|Mean change from baseline in SES-CD score at Week 12.|Proportion of subjects achieving SES-CD 25 and SES-CD 50 at Week 12.|Proportion of subjects achieving endoscopic remission (SES-CD less than or equal to 2) at Week 12.|Proportion of subjects achieving mucosal healing at Week 12.|Number of subjects with adverse events|Number of subjects with serious adverse events|Number of subjects with electrocardiogram findings of potential clinical importance.|Number of subjects withdrawal due to adverse events|Number of subjects with vital signs findings of potential clinical importance.|Number of subjects with laboratory tests findings of potential clinical importance.|Proportion of subjects achieving SES CD 25 and SES CD 50 at Week 64 among subjects who achieved SES CD 25 and SES CD 50 at week 12 respectively.|Proportion of subjects achieving clinically meaningful endoscopic improvement (CMEI response) at week 64 among subjects who achieved CMEI response at Week 12.","64 weeks|Baseline, week 12|Number of subjects achieving SES-CD 25 and SES-CD 50 at Week 12.|Number of subjects achieving endoscopic remission (SES-CD less than or equal to 2) at Week 12.|Number of subjects achieving mucosal healing at Week 12.|Number of participants with reported adverse events|Number of participants with reported serious adverse events|Number of participants with potentially clinically important electrocardiogram findings.|Number of subjects withdrawal due to adverse events.|Number of participants with potentially clinically important vital signs findings.|Number of participants with potentially clinically important laboratory findings.|Number of subjects achieving SES-CD 25 and SES-CD 50 at Week 64 among subjects who achieved SES CD 25 and SES CD 50 at week 12|Number of subject achieving clinically meaningful endoscopic improvement (CMEI response) at week 64 among subjects who achieved CMEI response at week 12.","Baseline, week 12|Week 12|Baseline up to 64 weeks|Baseline u to 64 weeks|week 64","ClinicalTrials.gov_Inquiries@pfizer.com","Pfizer CT.gov Call Center","1-800-718-1021","Concord, New South Wales, Australia, 2139|Subiaco, Western|Ballarat, Victoria, Australia, 3350|Jette, Belgium, 1090 University Hospitals LeuvenLeuven, Belgium, 3000 Chc - Saint-JosephLiÃ¨ge, Belgium, 4000|Banja Luka, Bosnia And Herzegovina, 78000|Winnipeg, Manitoba, Canada, R3A 1R9|Ottawa, Ontario, Canada, K1K 0T2|Zagreb, Hrvatska, Croatia, 10000|Rijeka, Croatia, 51000 Opca Bolnica Zadar, Odjel Za GastroenterologijuZadar, Croatia, 23000 Klinicka Bolnica Dubrava ZagrebZagreb, Croatia, 10000 Klinicki Bolnicki Centar Zagreb, Zavod Za Gastroenterologiju I HepatologijuZagreb, Croatia, 10000|Bilina, Czechia, 41801 Nemocnice Horovice, A.S.Horovice, Czechia, 268 31 Hepato-Gastroenterologie Hk S.R.O.Hradec Kralove, Czechia, 500 12 Medialpharma S.R.O.Hradec Kralove, Czechia, 500 12 Gastroenterologicka Ambulance A EndoskopieMost, Czechia, 43401 Artroscan, S.R.O., Gastroenterologicke OddeleniOstrava, Czechia, 722 00 Lekarna U VitkaOstrava, Czechia, 722 00 Nemocnice Strakonice, A.S., Interni OddeleniStrakonice, Czechia, 386 01 Nemocnice Strakonice, A.S.Strakonice, Czechia, 386 29|Tbilisi, Georgia, 0141 David Tatishvili Medical CenterTbilisi, Georgia, 0186|Bekescsaba, Hungary, 5600 Semmelweis Egyetem, Ii. Belgyogyaszati KlinikaBudapest, Hungary, 1088 Szent Janos Korhaz Es Eszak-Budai Egyesitett KorhazakBudapest, Hungary, 1125 Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz, Endoszkopos LaboratoriumGyula, Hungary, 5700 Clinfan Szolgaltato Kft.Szekszard, Hungary, 7100 Csolnoky Ferenc Korhaz Belgyogyaszati Centrum I. Belgyogyaszati OsztalyVeszprem, Hungary, 8200|Messina, Italy, 98125 Istituto Clinico Humanitas Irccs - Ibd CenterMilan, Italy, 20089 Aou Policlinico Di ModenaModena, Italy, 41124 Policlinico Gemelli/Complesso Integrato ColumbusRome, Italy, 00168 Korea, Republic Of, Korea Kyungpook National University HospitalDaegu, Korea, Korea, Republic Of, 41944 Korea, Republic Of Kangbuk Samsung HospitalSeoul, Korea, Republic Of, 03181 Severance Hospital, Yonsei University Health SystemSeoul, Korea, Republic Of, 03722 The Catholic University Of Korea, Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591|Brescia, Bs, Italy, 25123|Catanzaro, Cz, Italy, 88100|Rho, Milano, Italy, 20017|Katowice, Poland, 40-659 Etg KielceKielce, Poland, 25-355 Indywidualna Specjalstyczna Praktyka Lekarska Maciej ZymlaKnurow, Poland, 44-190 Szpital W Knurowie Sp. Z O.O.Knurow, Poland, 44-190 Centrum Badan Klinicznych JciKrakow, Poland, 30-348 Marta Dagmara Banach Marta Banach Specjalistyczny Gabinet NeurologicznyKrakow, Poland, 30-539 Centrum Medyczne EvitaKrakow, Poland, 31-153 Szpital Specjalistyczny Im. Ludwika Rydygiera W Krakowie Sp. Z O.O.Krakow, Poland, 31-826 Centrum Medyczne Szpital Swietej Rodziny Sp Z O.O.Lodz, Poland, 90-302 Pracownia Endoskopii Centrum Medyczne Szpital Swietej Rodziny Sp Z O.O.Lodz, Poland, 90-302 Medical Magnus ClinicLodz, Poland, 90-552 Wojewodzki Szpital Specjalistyczny Im. Bieganskiego W LodziLodz, Poland, 91-347 Gastromed Sp. Z O.O.Lublin, Poland, 20-582 Ai Centrum Medyczne Sp. Z O.O. Sp.K.Poznan, Poland, 61-113 Korczowski Bartosz Gabinet LekarskiRzeszow, Poland, 35-302 Endoskopia Sp. Z O. O.Sopot, Poland, 81-756 Szpital Sredzki Serca Jezusowego Sp. Z O.O.Sroda Wielkopolska, Poland, 63-000 Ez-Med Sp. Z O.O. Sp.K.Swidnica, Poland, 58-100 Pracownia Endoskopii Szpital MswSzczecin, Poland, 70-001 Twoja Przychodnia Szczecinskie Centrum MedyczneSzczecin, Poland, 71-270 Gastromed Kopon, Zmudzinski I Wspolnicy Sp.J.Torun, Poland, 87-100 Centrum Zdrowia MdmWarszawa, Poland, 00-635 Centrum Diagnostyczno-Lecznicze Barska Sp. Z O. O.Wloclawek, Poland, 87-800 Centrum Gastrologiczno HepatologiczneWroclaw, Poland, 50-555 LexmedicaWroclaw, Poland, 53-114 Russian Federation, Sestroretsk Spb Sbih \"City Hospital #40 Of The Kurortnyi Region\"Saint-Petersburg, Sestroretsk, Russian Federation, 197706 Russian Federation Llc \"Alliance Biomedical-Ural Group\"Izhevsk, Russian Federation, 426061 Clinic Of Fsbei He Ksmu Moh RfKrasnodar, Russian Federation, 350072 Llc \"Olla-Med\"Moscow, Russian Federation, 105554 Sechenov University On The Base Of Institute Of Translational Medicine And BiotechnologyMoscow, Russian Federation, 119435 Limited Liability Company \"Medical Center Sibnovomed\"Novosibirsk, Russian Federation, 630005 Federal State Budgetary Scientific Institution \"Scientific Research Institute Of Physiology AndNovosibirsk, Russian Federation, 630117 Clinic At Fsbei He \"Omsk State Medical University\" Moh RfOmsk, Russian Federation, 644050 Llc \"New Clinic\"Pyatigorsk, Russian Federation, 357500 Limited Liability Company \"Riat\"Saint-Petersburg, Russian Federation, 195220 Saint-Petersburg State Budgetary Healthcare Institution \"City Hospital #26\"Saint-Petersburg, Russian Federation, 196247 Private Institution Educational Organization Of Higher EducationSamara, Russian Federation, 443011 Non-State Healthcare Institution 'Railway Clinical Hospital At Samara Station Of Open Joint StockSamara, Russian Federation, 443029 Saint-Petersburg State Budgetary Healthcare Institution \"City Clinical Hospital Of The RighteousSt. Petersburg, Russian Federation, 197706|Tychy, Silesia, Poland, 43-100|Zemun, Beograd, Serbia, 11080|Beograd, Serbia, 11000|Beograd, Srbija, Serbia, 11000 Klinicki Centar KragujevacKragujevac, Srbija, Serbia, 34000 Klinicki Centar NisNis, Srbija, Serbia, 18000 Opsta Bolnica SuboticaSubotica, Srbija, Serbia, 24000 Opsta Bolnica \"Djordje Joanovic\", Odeljenje Interno, Odsek GastroenterologijaZrenjanin, Srbija, Serbia, 23000|Banska Bystrica, Slovakia, 975 17 Breznianske Centrum Gastroenterologie S.R.O.Brezno, Slovakia, 97701 Km Management Spol. S.R.O.Nitra, Slovakia, 949 01 Accout Center S.R.O. Gastroenterologicka AmbulanciaSahy, Slovakia, 936 01 Endomed, S.R.O.Vranov Nad Toplou, Slovakia, 093 01|Santander, Cantabria, Spain, 39008|Granada, Spain, 18014 Hospital Universitario Ramon Y CajalMadrid, Spain, 28034 Hospital Universitario Virgen Del RocioSevilla, Spain, 41013 Hospital Universitari I Politecnic La FeValencia, Spain, 46026|Ankara, Turkey, 06100 Ankara Universitesi Tip Fakultesi, Ibn-I Sina HastanesiAnkara, Turkey, 06100 Hacettepe Universitesi Tip Fakultesi, Ic Hastaliklari AnabilimAnkara, Turkey, 06230 Hacettepe Universitesi Tip FakultesiAnkara, Turkey, 06230 Bezmialem Vakif Universitesi Tip Fakultesi HastanesiIstanbul, Turkey, 34093 Istanbul Universitesi Cerrahpasa Tip FacultesiIstanbul, Turkey, 34098 Istanbul Universitesi Cerrahpasa Tip FakultesiIstanbul, Turkey, 34098 Erciyes Universitesi Tip FakultesiKayseri, Turkey, 38039 Mersin Universitesi Tip Fakultesi Hastanesi, Ic HastaliklariMersin, Turkey, 33110 Mersin Universitesi Tip Fakultesi HastanesiMersin, Turkey, 33110 Karadeniz Teknik Universitesi Tip Fakultesi, Ic HastaliklariTrabzon, Turkey, 61080 Karadeniz Teknik Universitesi Tip FakultesiTrabzon, Turkey, 61080 Bulent Ecevit Universitesi Tip FakultesiZonguldak, Turkey, 67600|Chernivtsi, Ukraine, 58001 Regional Municipal Institution \"Chernivtsi Regional Clinical Hospital\", Surgery DepartmentChernivtsi, Ukraine, 58001 Traumatology And Orthopedic Center LlcChernivtsi, Ukraine, 58023 Municipal Healthcare Institution Kharkiv City Clinical Hospital #2 N.A. Prof. O.O. ShalimovKharkiv, Ukraine, 61037 Private Enterprise Of Private Manufacturing Company \"Acinus\", Medical And Diagnostic CenterKropyvnytskyi, Ukraine, 25006 Kyiv Municipal Clinical Hospital #18, Proctology DepartmentKyiv, Ukraine, 01030 Medical Center \"Universal Clinic Oberig\" Of \"Kapital\" Llc, Gastro CenterKyiv, Ukraine, 03680 Lviv Clinical Hospital On Railway Transport Of Health Care Center Branch Of Pjsc Ukrainian RailwayLviv, Ukraine, 79007 Vinnytsia City Clinical Hospital No.1Vinnytsia, Ukraine, 21000 Private Small-Scale Enterprise Medical Center \"Pulse\"Vinnytsia, Ukraine, 21001 Vinnytsia Regional Clinical Hospital For War VeteransVinnytsia, Ukraine, 21005 Vinnytsia Regional Clinical Hospital N.A. M.I.PyrohovVinnytsia, Ukraine, 21018|Dothan, Alabama, United States, 36301 Gut P.C., Dba Digestive Health Specialists Of The SoutheastDothan, Alabama, United States, 36305|Beverly Hills, California, United States, 90210 Long Beach Clinical Trial Services, Inc.Long Beach, California, United States, 90806 Entertainment Medical GroupLos Angeles, California, United States, 90036 Gastrointestinal Biosciences Clinical Trials, LlcLos Angeles, California, United States, 90067 Alliance Clinical Research, LlcPoway, California, United States, 92064|Clearwater, Florida, United States, 33756-3839 West Coast Endoscopy CenterClearwater, Florida, United States, 33756 Gastro FloridaClearwater, Florida, United States, 33762 Millenia Surgery CenterOrlando, Florida, United States, 32811 Hmd Research LlcOrlando, Florida, United States, 32819 Orlando Gastroenterology, PaOrlando, Florida, United States, 32835|Shawnee Mission, Kansas, United States, 66217|Houma, Louisiana, United States, 70360 Gulf Coast Surgical CenterHouma, Louisiana, United States, 70360 The Hearing Center (Audiology)Houma, Louisiana, United States, 70360|Chevy Chase, Maryland, United States, 20815 Mgg Group Co., Inc., Chevy Chase Clinical ResearchChevy Chase, Maryland, United States, 20815|Boston, Massachusetts, United States, 02115 Mass Eye And Ear, LongwoodBoston, Massachusetts, United States, 02115 Brigham And Women'S HospitalChestnut Hill, Massachusetts, United States, 02467 Umass Memorial Medical CenterWorcester, Massachusetts, United States, 01655 University Of Massachusetts Medical SchoolWorcester, Massachusetts, United States, 01655|Caro, Michigan, United States, 48723 Clinical Research Institute Of Michigan, LlcChesterfield, Michigan, United States, 48047 Eastside Endoscopy CenterMacomb, Michigan, United States, 48044 Eastside Endoscopy CenterSaint Clair Shores, Michigan, United States, 48081|New York, New York, United States, 10021 New York Presbyterian Hospital - Weill Cornell Medical College (Colonoscopy)New York, New York, United States, 10065 New York Presbyterian Hospital - Weill Cornell Medical College Investigational PharmacyNew York, New York, United States, 10065 Weill Cornell Medical College - New York Presbyterian Hospital (Endoscopy Suite)New York, New York, United States, 10065 Weill Cornell Medical College - New York Presbyterian HospitalNew York, New York, United States, 10065 Digiovanna Institute For Medical Education & ResearchNorth Massapequa, New York, United States, 11758-1802|Chapel Hill, North Carolina, United States, 27514 Unc Hospitals Endoscopy Center At MeadowmontChapel Hill, North Carolina, United States, 27517 University Of North Carolina At Chapel HillChapel Hill, North Carolina, United States, 27599 Gastroenterology Associates Of The Piedmont, PaWinston-Salem, North Carolina, United States, 27103 Pmg Research Of Winston-Salem, LlcWinston-Salem, North Carolina, United States, 27103|Kingsport, Tennessee, United States, 37660 Holston Medical GroupKingsport, Tennessee, United States, 37660 Holston Valley Surgery Center (Testing Only)Kingsport, Tennessee, United States, 37660|Arlington, Texas, United States, 76012 Envision Imaging (Cxr)Arlington, Texas, United States, 76012 Texas Clinical Research Institiute, LlcArlington, Texas, United States, 76012 Hermann Drive Surgical HospitalHouston, Texas, United States, 77004 Pearland Surgery CenterHouston, Texas, United States, 77047 Gulf Coast Research Group, LlcHouston, Texas, United States, 77098 North Texas Research AssociatesMckinney, Texas, United States, 75069 Lonestar Endoscopy, LlpSouthlake, Texas, United States, 76092 Texas Digestive Disease ConsultantsSouthlake, Texas, United States, 76092|Fairfax, Virginia, United States, 22031","Alabama|California|Florida|Kansas|Louisiana|Maryland|Massachusetts|Michigan|New York|North Carolina|Tennessee|Texas|Virginia","Australia|Belgium|Bosnia And Herzegovina|Canada|Croatia|Czechia|Georgia|Hungary|Italy|Poland|Serbia|Slovakia|Spain|Turkey|Ukraine|United States","New South Wales Concord Repatriation General Hospital|Saint John Of God Subiaco Hospital|Victoria Ballarat Base Hospital|University Hospital Brussels|Javna Zdravstvena Ustanova Univerzitetski Klinicki Centar Republike Srpske,|Manitoba Winnipeg Regional Health Authority - Health Sciences Centre, Winnipeg|Ontario HÃ´pital Montfort|Hrvatska Klinicki Bolnicki Centar Sestre Milosrdnice|Klinicki Bolnicki Centar Rijeka, Odjel Za Gastroenterologiju|Lekarna Altea|The First University Clinic Of Tsmu|Bekes Megyei Kozponti Korhaz, Rethy Pal Tagkorhaz|A.O.U. Policlinico G. Martino|Bs A.O.Spedali Civili|Cz Univ. \"Magna Graecia\" Di Catanzaro|Milano Asst Rhodense - Ospedale Di Circolo Di Rho|Niepubliczny Zaklad Opieki Zdrowotnej All-Medicus|Silesia H-T. Centrum Medyczne-Endoterapia|Beograd Klinicko Bolnicki Centar \"Bezanijska Kosa\"|Klinicko Bolnicki Centar Zvezdara, Klinika Za Interne Bolesti,|Srbija Klinicki Centar Srbije, Klinika Za Gastroenterohepatologiju|Fakultna Nemocnica S Poliklinikou F.D. Roosevelta Banska Bystrica|Cantabria Hospital Universitario Marques De Valdecilla|Hospital Universitario Virgen De Las Nieves De Granada|Ankara Universitesi Tip Fakultesi, Ibn-I Sina Hastanesi, Ic Hastaliklari Anabilim Dali,|Regional Municipal Institution \"Chernivtsi Regional Clinical Hospital\", Gastroenterology Department,|Dothan Surgery Center|Brighton Surgical Center|Gastro Florida|Westglen Gastrointestinal Consultants, P.A.|Cronola, Llc|Chevy Chase Endoscopy Center|Brigham And Women's Hospital|Caro Health Plaza|Weill Cornell Medical College (Clinical Site)|Unc Hospitals|Holston Medical Group (Drug Shipment Only)|Cross Timbers Surgery Center L.P. (Colonoscopy)|Verity Research, Inc.",{"$nulls":3},"Pfizer CT.gov Call Center","2018-11-16","2020-05-25T16:36:03.781","2020-05-26T17:10:42.972","NCT03395184"]
["5ecbf3f3fe30261b1a04820a","NCT03395184","2018-12-11","Pfizer","PFE","Recruiting","Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PFâ€‘06700841 In Subjects With Moderate To Severe Crohn's Disease","Brepocitinib|Pf-06651600","JAK1 Inhibitor|TYK2 Inhibitor|JAK1 Inhibitor|JAK3 Inhibitor","Yes","['Brepocitinib', 'Pf-06651600']","Yes","['TYK2 Inhibitor', 'JAK3 Inhibitor']","Phase 2",2,250,"Anticipated","2018-02-02","2020-02-04","DAS","Disease Activity Score",{"$nulls":3},"The objectives of this study are to evaluate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-06651600 (200 mg for 8 weeks followed by 50 mg for 4 weeks) dosed once daily and PF-06700841 (60 mg for 12 weeks) dosed once daily during an induction period of 12 weeks, followed by an open label extension period at doses of 50 mg and 30 mg of PF 06651600 and PF 06700841, respectively, for 52 weeks.",null,"A PHASE 2A, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ORAL PF-06651600 AND PF-06700841 AS INDUCTION AND OPEN LABEL EXTENSION TREATMENT IN SUBJECTS WITH MODERATE TO SEVERE CROHN'S DISEASE","B7981007","Crohn's Disease","Crohn Disease","Gastrointestinal Diseases","Gastrointestinal","Experimental","PF-06700841 or placebo|PF-06651600 or placebo",null,"Drug","Placebo PF-06700841|PF-06700841|Placebo PF-06651600|PF-06651600","12 weeks, followed by PF-06700841, 30 mg QD for 52 weeks.|60 mg QD for 12 weeks followed by 30 mg QD for up to 52 weeks|12 weeks, followed by PF-06651600, 50 mg QD for 52 weeks|200 mg QD for 8 weeks, followed by 50 mg QD up to 56 weeks",null,"PF-06700841 or placebo|PF-06651600 or placebo","\n\n 1. Male and/or female subjects 18 years to 75 years of age\n 2. Documented diagnosis of ileal, ileocolonic, or colonic CD with a minimum disease duration of 3 months, as determined by endoscopic and histopathology assessment.\n 3. Endoscopic confirmation of active disease with total SES CD total score of at least 7. For isolated ileal disease, SES CD total score should be at least 4.\n 4. An average daily liquid/soft stool frequency (SF) greater than or equal to 2.5 or daily abdominal pain (AP) greater than or equal to 2.0.\n 5. Must have inadequate response to, loss of response to, or intolerance to at least one conventional therapy for CD:â€¢Steroids; Immunosuppressants (azathioprine [AZA], 6 MP, or methotrexate [MTX]); Anti TNF inhibitors (infliximab, adalimumab,certolizumab); Anti integrin inhibitors (eg, vedolizumab); Anti IL 12/23 inhibitor (ustekinumab).\n    \n    \n 6. Subjects currently receiving the following treatment for CD are eligible providing they have been on stable doses as described below: * Oral corticosteroids (prednisone or equivalent up to 25 mg/day; budesonide up to 9 mg/day). Stable dose for at least 2 weeks prior to baseline. If oral corticosteroids have been recently discontinued, they must have been stopped at least 2 weeks prior to baseline. Decreases in steroid use due to AEs are allowed.\n     * Oral 5 ASA or sulfasalazine are allowed providing that the dose is stable for at least 4 weeks prior to baseline.\n     * Crohn's disease related antibiotics are allowed providing that the dose is stable for at least 4 weeks prior to baseline. If antibiotics are stopped prior to baseline, they must be discontinued at least 4 days prior to baseline.\n    \n    \n\n","\n\n 1.  Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, diverticular disease, ulcerative colitis (UC), or clinical findings suggestive of UC.\n 2.  Presence of active (draining) fistulae or intra abdominal or perineal abscesses.\n 3.  Strictures with obstructive symptoms.\n 4.  Short bowel syndrome.\n 5.  History of bowel perforation requiring surgical intervention within the past 12 months.\n 6.  Previous bowel surgery resulting in an existing stoma. Subjects who have a j pouch are excluded, as a j pouch can result in a stoma.\n 7.  History of bowel surgery within 6 months prior to baseline.\n 8.  Subjects displaying clinical signs of fulminant colitis or toxic megacolon.\n 9.  Subjects with primary sclerosing cholangitis.\n 10. Subjects with evidence of colonic adenomas, dysplasia or neoplasia.\n 11. Abnormal findings on the chest x ray film such as presence of tuberculosis (TB), general infections, heart failure, or malignancy.\n 12. Any history of either untreated or inadequately treated latent or active TB infection, current treatment for active or latent TB infection or evidence of currently active TB by chest x ray, residing with or frequent close contact with individual(s) with active TB.\n 13. Subjects receiving the following therapies within the time period described below or expected to receive any of these therapies during the study period: 1.  >9 mg/day of oral budesonide or >25 mg/day of prednisone or equivalent oral systemic corticosteroid dose within 2 weeks prior to baseline.\n      2.  IV, IM (parenteral), or topical (rectal) treatment of 5 ASA or corticosteroid enemas/suppositories within 2 weeks prior to baseline.\n      3.  Azathioprine, 6 mercaptopurine, or methotrexate within 2 weeks prior to baseline.\n      4.  Anti TNF inhibitors (or biosimilars thereof) as described below: * Infliximab within 8 weeks prior to baseline;\n           * Adalimumab within 8 weeks prior to baseline;\n           * Certolizumab within 8 weeks prior to baseline;\n          \n          \n      5.  Anti integrin inhibitors (eg, vedolizumab) within 8 weeks prior to baseline.\n      6.  Ustekinumab within 8 weeks prior to baseline.\n      7.  Interferon therapy within 8 weeks prior to baseline.\n      8.  Subjects with prior treatment with lymphocyte depleting agents/therapies within 1 year prior to baseline (eg, CamPath[alemtuzumab], alkylating agents [eg, cyclophosphamide or chlorambucil], total lymphoid irradiation, etc).\n      9.  Subjects who have received rituximab or other selective B lymphocyte depleting agents within 1 year prior to baseline.\n      10. Subjects previously receiving leukocyte apheresis, including selective lymphocyte, monocyte, or granulocyte apheresis, or plasma exchange within 6 months prior to baseline.\n      11. Other marketed immunosuppressants or biologics with immunomodulatory properties within 3 months prior to baseline.\n      12. Subjects who have received other JAK inhibitors within 3 months prior to baseline.\n      13. Subjects who have not responded to or have been intolerant of other JAK inhibitors.\n      14. Other investigational procedures(s) or product(s), such as immunosuppressants used in transplantation (eg, mycophenolate mofetil, cyclosporine, rapamycin, or tacrolimus) or live (attenuated) vaccine within 30 days prior to baseline.","TNF","tumor necrosis factor","Protein","Lung, Breast, Ovary","Actual","2018-01-10","Actual","Anticipated","2021-02-18","Anticipated","2018-12-01","2017-12-05","2018-01-03","2018-12-07","Yes",null,"Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years","75 Years","All",null,"No","Yes\nInformation relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests",null,"URL: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7981007&StudyName=A+Phase+2a%2C+Double-blind%2C+Randomized%2C+Placebo-controlled%2C+Parallel+Group+Study+To+Evaluate+The+Efficacy+And+Safety+Of+Oral+Pf-06651600+And+Pf-06700841+As+Induction+And+Open+Label+Extension+Treatment+In+Subjects+With+Moderate+To+Severe+Crohn%E2%80%99s+Disease [https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7981007&StudyName=A+Phase+2a%2C+Double-blind%2C+Randomized%2C+Placebo-controlled%2C+Parallel+Group+Study+To+Evaluate+The+Efficacy+And+Safety+Of+Oral+Pf-06651600+And+Pf-06700841+As+Induction+And+Open+Label+Extension+Treatment+In+Subjects+With+Moderate+To+Severe+Crohn%E2%80%99s+Disease] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To obtain contact information for a study center near you, click here.",null,"Yes","No",{"$nulls":17},"2017-003359-43|PIZZICATO","EudraCT Number|Alias Study Number","Proportion of subjects achieving clinically meaningful endoscopic improvement (reduction of more than or equal to 3 points from baseline in Simplified Endoscopic Activity Score for Crohn's Disease (SES-CD) at Week 12","12 weeks",null,"Number of participants with potentially clinically important serious infections findings|Mean change from baseline in SES-CD score at Week 12.|Proportion of subjects achieving SES-CD 25 and SES-CD 50 at Week 12.|Proportion of subjects achieving endoscopic remission (SES-CD less than or equal to 2) at Week 12.|Proportion of subjects achieving mucosal healing at Week 12.|Number of subjects with adverse events|Number of subjects with serious adverse events|Number of subjects with electrocardiogram findings of potential clinical importance.|Number of subjects withdrawal due to adverse events|Number of subjects with vital signs findings of potential clinical importance.|Number of subjects with laboratory tests findings of potential clinical importance.|Proportion of subjects achieving SES CD 25 and SES CD 50 at Week 64 among subjects who achieved SES CD 25 and SES CD 50 at week 12 respectively.|Proportion of subjects achieving clinically meaningful endoscopic improvement (CMEI response) at week 64 among subjects who achieved CMEI response at Week 12.","64 weeks|Baseline, week 12|Number of subjects achieving SES-CD 25 and SES-CD 50 at Week 12.|Number of subjects achieving endoscopic remission (SES-CD less than or equal to 2) at Week 12.|Number of subjects achieving mucosal healing at Week 12.|Number of participants with reported adverse events|Number of participants with reported serious adverse events|Number of participants with potentially clinically important electrocardiogram findings.|Number of subjects withdrawal due to adverse events.|Number of participants with potentially clinically important vital signs findings.|Number of participants with potentially clinically important laboratory findings.|Number of subjects achieving SES-CD 25 and SES-CD 50 at Week 64 among subjects who achieved SES CD 25 and SES CD 50 at week 12|Number of subject achieving clinically meaningful endoscopic improvement (CMEI response) at week 64 among subjects who achieved CMEI response at week 12.","Baseline, week 12|Week 12|Baseline up to 64 weeks|Baseline u to 64 weeks|week 64","ClinicalTrials.gov_Inquiries@pfizer.com","Pfizer CT.gov Call Center","1-800-718-1021","Concord, New South Wales, Australia, 2139|Subiaco, Western|Ballarat, Victoria, Australia, 3350|Jette, Belgium, 1090 University Hospitals LeuvenLeuven, Belgium, 3000 Chc - Saint-JosephLiÃ¨ge, Belgium, 4000|Banja Luka, Bosnia And Herzegovina, 78000 Sveucilisna Klinicka Bolnica Mostar,Mostar, Bosnia And Herzegovina, 88000|Winnipeg, Manitoba, Canada, R3A 1R9|Ottawa, Ontario, Canada, K1K 0T2|Zagreb, Hrvatska, Croatia, 10000|Rijeka, Croatia, 51000 Klinicki Bolnicki Centar Split, Zavod Za GastroenterologijuSplit, Croatia, 21000 Opca Bolnica Zadar, Odjel Za GastroenterologijuZadar, Croatia, 23000 Klinicka Bolnica Dubrava ZagrebZagreb, Croatia, 10000 Klinicki Bolnicki Centar Zagreb, Zavod Za Gastroenterologiju I HepatologijuZagreb, Croatia, 10000|Bilina, Czechia, 41801 Nemocnice Horovice, A.S.Horovice, Czechia, 268 31 Hepato-Gastroenterologie Hk S.R.O.Hradec Kralove, Czechia, 500 12 Medialpharma S.R.O.Hradec Kralove, Czechia, 500 12 Gastroenterologicka Ambulance A EndoskopieMost, Czechia, 43401 Artroscan, S.R.O., Gastroenterologicke OddeleniOstrava, Czechia, 722 00 Lekarna U VitkaOstrava, Czechia, 722 00 Nemocnice Strakonice, A.S., Interni OddeleniStrakonice, Czechia, 386 01 Nemocnice Strakonice, A.S.Strakonice, Czechia, 386 29|Tbilisi, Georgia, 0141 David Tatishvili Medical CenterTbilisi, Georgia, 0186|Bekescsaba, Hungary, 5600 Semmelweis Egyetem, Ii. Belgyogyaszati KlinikaBudapest, Hungary, 1088 Szent Janos Korhaz Es Eszak-Budai Egyesitett KorhazakBudapest, Hungary, 1125 Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz, Endoszkopos LaboratoriumGyula, Hungary, 5700 Clinfan Szolgaltato Kft.Szekszard, Hungary, 7100 Csolnoky Ferenc Korhaz Belgyogyaszati Centrum I. Belgyogyaszati OsztalyVeszprem, Hungary, 8200|Messina, Italy, 98125 Istituto Clinico Humanitas Irccs - Ibd CenterMilan, Italy, 20089 Aou Policlinico Di ModenaModena, Italy, 41124 Policlinico Universitario Campus Bio-MedicoRoma, Italy, 00128 Policlinico Gemelli/Complesso Integrato ColumbusRome, Italy, 00168 Korea, Republic Of, Korea Kyungpook National University HospitalDaegu, Korea, Korea, Republic Of, 41944 Korea, Republic Of Kangbuk Samsung HospitalSeoul, Korea, Republic Of, 03181 Severance Hospital, Yonsei University Health SystemSeoul, Korea, Republic Of, 03722 The Catholic University Of Korea, Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591|Brescia, Bs, Italy, 25123|Catanzaro, Cz, Italy, 88100|Rho, Milano, Italy, 20017|Katowice, Poland, 40-659 Etg KielceKielce, Poland, 25-355 Indywidualna Specjalstyczna Praktyka Lekarska Maciej ZymlaKnurow, Poland, 44-190 Szpital W Knurowie Sp. Z O.O.Knurow, Poland, 44-190 Centrum Badan Klinicznych JciKrakow, Poland, 30-348 Marta Dagmara Banach Marta Banach Specjalistyczny Gabinet NeurologicznyKrakow, Poland, 30-539 Centrum Medyczne EvitaKrakow, Poland, 31-153 Szpital Specjalistyczny Im. Ludwika Rydygiera W Krakowie Sp. Z O.O.Krakow, Poland, 31-826 Centrum Medyczne Szpital Swietej Rodziny Sp Z O.O.Lodz, Poland, 90-302 Pracownia Endoskopii Centrum Medyczne Szpital Swietej Rodziny Sp Z O.O.Lodz, Poland, 90-302 Medical Magnus ClinicLodz, Poland, 90-552 Wojewodzki Szpital Specjalistyczny Im. Bieganskiego W LodziLodz, Poland, 91-347 Gastromed Sp. Z O.O.Lublin, Poland, 20-582 Ai Centrum Medyczne Sp. Z O.O. Sp.K.Poznan, Poland, 61-113 Korczowski Bartosz Gabinet LekarskiRzeszow, Poland, 35-302 Endoskopia Sp. Z O. O.Sopot, Poland, 81-756 Szpital Sredzki Serca Jezusowego Sp. Z O.O.Sroda Wielkopolska, Poland, 63-000 Ez-Med Sp. Z O.O. Sp.K.Swidnica, Poland, 58-100 Pracownia Endoskopii Szpital MswSzczecin, Poland, 70-001 Twoja Przychodnia Szczecinskie Centrum MedyczneSzczecin, Poland, 71-270 Gastromed Kopon, Zmudzinski I Wspolnicy Sp.J.Torun, Poland, 87-100 Centrum Zdrowia MdmWarszawa, Poland, 00-635 Centrum Diagnostyczno-Lecznicze Barska Sp. Z O. O.Wloclawek, Poland, 87-800 Melita Medical Sp. Z O.O.Wroclaw, Poland, 50-449 Centrum Gastrologiczno HepatologiczneWroclaw, Poland, 50-555 LexmedicaWroclaw, Poland, 53-114 Russian Federation, Sestroretsk Spb Sbih \"City Hospital #40 Of The Kurortnyi Region\"Saint-Petersburg, Sestroretsk, Russian Federation, 197706 Russian Federation Llc \"Alliance Biomedical-Ural Group\"Izhevsk, Russian Federation, 426061 Clinic Of Fsbei He Ksmu Moh RfKrasnodar, Russian Federation, 350072 Llc \"Olla-Med\"Moscow, Russian Federation, 105554 Sechenov University On The Base Of Institute Of Translational Medicine And BiotechnologyMoscow, Russian Federation, 119435 Limited Liability Company \"Medical Center Sibnovomed\"Novosibirsk, Russian Federation, 630005 Federal State Budgetary Scientific Institution \"Scientific Research Institute Of Physiology AndNovosibirsk, Russian Federation, 630117 Clinic At Fsbei He \"Omsk State Medical University\" Moh RfOmsk, Russian Federation, 644050 Llc \"New Clinic\"Pyatigorsk, Russian Federation, 357500 Limited Liability Company \"Riat\"Saint-Petersburg, Russian Federation, 195220 Saint-Petersburg State Budgetary Healthcare Institution \"City Hospital #26\"Saint-Petersburg, Russian Federation, 196247 Private Institution Educational Organization Of Higher EducationSamara, Russian Federation, 443011 Non-State Healthcare Institution 'Railway Clinical Hospital At Samara Station Of Open Joint StockSamara, Russian Federation, 443029 Saint-Petersburg State Budgetary Healthcare Institution \"City Clinical Hospital Of The RighteousSt. Petersburg, Russian Federation, 197706|Tychy, Silesia, Poland, 43-100|Zemun, Beograd, Serbia, 11080|Beograd, Serbia, 11000 Klinicko Bolnicki Centar Zemun, Klinika Za Internu Medicinu,Zemun, Beograd, Serbia, 11080|Beograd, Srbija, Serbia, 11000 Klinicki Centar KragujevacKragujevac, Srbija, Serbia, 34000 Klinicki Centar NisNis, Srbija, Serbia, 18000 Opsta Bolnica SuboticaSubotica, Srbija, Serbia, 24000 Opsta Bolnica \"Djordje Joanovic\", Odeljenje Interno, Odsek GastroenterologijaZrenjanin, Srbija, Serbia, 23000|Banska Bystrica, Slovakia, 975 17 Breznianske Centrum Gastroenterologie S.R.O.Brezno, Slovakia, 97701 Km Management Spol. S.R.O.Nitra, Slovakia, 949 01 Accout Center S.R.O. Gastroenterologicka AmbulanciaSahy, Slovakia, 936 01 Endomed, S.R.O.Vranov Nad Toplou, Slovakia, 093 01|Santander, Cantabria, Spain, 39008|Granada, Spain, 18014 Hospital Universitario Ramon Y CajalMadrid, Spain, 28034 Hospital Universitario Virgen Del RocioSevilla, Spain, 41013 Hospital Universitari I Politecnic La FeValencia, Spain, 46026|Ankara, Turkey, 06100 Ankara Universitesi Tip Fakultesi, Ibn-I Sina HastanesiAnkara, Turkey, 06100 Hacettepe Universitesi Tip Fakultesi, Ic Hastaliklari AnabilimAnkara, Turkey, 06230 Hacettepe Universitesi Tip FakultesiAnkara, Turkey, 06230 Bezmialem Vakif Universitesi Tip Fakultesi HastanesiIstanbul, Turkey, 34093 Istanbul Universitesi Cerrahpasa Tip FacultesiIstanbul, Turkey, 34098 Istanbul Universitesi Cerrahpasa Tip FakultesiIstanbul, Turkey, 34098 Erciyes Universitesi Tip FakultesiKayseri, Turkey, 38039 Kocaeli Universitesi Tip FakultesiKocaeli, Turkey, 41380 Mersin Universitesi Tip Fakultesi Hastanesi, Ic HastaliklariMersin, Turkey, 33110 Mersin Universitesi Tip Fakultesi HastanesiMersin, Turkey, 33110 Karadeniz Teknik Universitesi Tip Fakultesi, Ic HastaliklariTrabzon, Turkey, 61080 Karadeniz Teknik Universitesi Tip FakultesiTrabzon, Turkey, 61080 Bulent Ecevit Universitesi Tip FakultesiZonguldak, Turkey, 67600|Chernivtsi, Ukraine, 58001 Regional Municipal Institution \"Chernivtsi Regional Clinical Hospital\", Surgery DepartmentChernivtsi, Ukraine, 58001 Traumatology And Orthopedic Center LlcChernivtsi, Ukraine, 58023 Municipal Healthcare Institution Kharkiv City Clinical Hospital #2 N.A. Prof. O.O. ShalimovKharkiv, Ukraine, 61037 Private Enterprise Of Private Manufacturing Company \"Acinus\", Medical And Diagnostic CenterKropyvnytskyi, Ukraine, 25006 Kyiv Municipal Clinical Hospital #18, Proctology DepartmentKyiv, Ukraine, 01030 Medical Center \"Universal Clinic Oberig\" Of \"Kapital\" Llc, Gastro CenterKyiv, Ukraine, 03680 Lviv Clinical Hospital On Railway Transport Of Health Care Center Branch Of Pjsc Ukrainian RailwayLviv, Ukraine, 79007 Vinnytsia City Clinical Hospital No.1Vinnytsia, Ukraine, 21000 Private Small-Scale Enterprise Medical Center \"Pulse\"Vinnytsia, Ukraine, 21001 Vinnytsia Regional Clinical Hospital For War VeteransVinnytsia, Ukraine, 21005 Vinnytsia Regional Clinical Hospital N.A. M.I.PyrohovVinnytsia, Ukraine, 21018|Dothan, Alabama, United States, 36301 Gut P.C., Dba Digestive Health Specialists Of The SoutheastDothan, Alabama, United States, 36305|Beverly Hills, California, United States, 90210 Long Beach Clinical Trial Services, Inc.Long Beach, California, United States, 90806 Entertainment Medical GroupLos Angeles, California, United States, 90036 Gastrointestinal Biosciences Clinical Trials, LlcLos Angeles, California, United States, 90067 Alliance Clinical Research, LlcPoway, California, United States, 92064|Clearwater, Florida, United States, 33756-3839 West Coast Endoscopy CenterClearwater, Florida, United States, 33756 Gastro FloridaClearwater, Florida, United States, 33762 Millenia Surgery CenterOrlando, Florida, United States, 32811 Hmd Research LlcOrlando, Florida, United States, 32819 Orlando Gastroenterology, PaOrlando, Florida, United States, 32835|Shawnee Mission, Kansas, United States, 66217|Houma, Louisiana, United States, 70360 Gulf Coast Surgical CenterHouma, Louisiana, United States, 70360 The Hearing Center (Audiology)Houma, Louisiana, United States, 70360|Chevy Chase, Maryland, United States, 20815 Mgg Group Co., Inc., Chevy Chase Clinical ResearchChevy Chase, Maryland, United States, 20815|Boston, Massachusetts, United States, 02115 Mass Eye And Ear, LongwoodBoston, Massachusetts, United States, 02115 Brigham And Women'S HospitalChestnut Hill, Massachusetts, United States, 02467 Umass Memorial Medical CenterWorcester, Massachusetts, United States, 01655 University Of Massachusetts Medical SchoolWorcester, Massachusetts, United States, 01655|Caro, Michigan, United States, 48723 Clinical Research Institute Of Michigan, LlcChesterfield, Michigan, United States, 48047 Eastside Endoscopy CenterMacomb, Michigan, United States, 48044 Eastside Endoscopy CenterSaint Clair Shores, Michigan, United States, 48081|New York, New York, United States, 10021 New York Presbyterian Hospital - Weill Cornell Medical College (Colonoscopy)New York, New York, United States, 10065 New York Presbyterian Hospital - Weill Cornell Medical College Investigational PharmacyNew York, New York, United States, 10065 Weill Cornell Medical College - New York Presbyterian Hospital (Endoscopy Suite)New York, New York, United States, 10065 Weill Cornell Medical College - New York Presbyterian HospitalNew York, New York, United States, 10065 Digiovanna Institute For Medical Education And ResearchNorth Massapequa, New York, United States, 11758-1853|Chapel Hill, North Carolina, United States, 27514 Unc Hospitals Endoscopy Center At MeadowmontChapel Hill, North Carolina, United States, 27517 University Of North Carolina At Chapel HillChapel Hill, North Carolina, United States, 27599 Gastroenterology Associates Of The Piedmont, PaWinston-Salem, North Carolina, United States, 27103 Pmg Research Of Winston-Salem, LlcWinston-Salem, North Carolina, United States, 27103|Kingsport, Tennessee, United States, 37660 Holston Medical GroupKingsport, Tennessee, United States, 37660 Holston Valley Surgery Center (Testing Only)Kingsport, Tennessee, United States, 37660 Vanderbilt University Medical CenterNashville, Tennessee, United States, 37212-1375 Vanderbilt University Medical CenterNashville, Tennessee, United States, 37212-1610 Vanderbilt University Medical Center - Gi Endoscopy LabNashville, Tennessee, United States, 37232-5543 Vanderbilt University Medical CenterNashville, Tennessee, United States, 37232-7610 Vanderbilt University Medical Center - Gi Research RegulatoryNashville, Tennessee, United States, 37232|Arlington, Texas, United States, 76012 Envision Imaging (Cxr)Arlington, Texas, United States, 76012 Texas Clinical Research Institiute, LlcArlington, Texas, United States, 76012 Hermann Drive Surgical HospitalHouston, Texas, United States, 77004 Pearland Surgery CenterHouston, Texas, United States, 77047 Gulf Coast Research Group, LlcHouston, Texas, United States, 77098 North Texas Research AssociatesMckinney, Texas, United States, 75069 Lonestar Endoscopy, LlpSouthlake, Texas, United States, 76092 Texas Digestive Disease ConsultantsSouthlake, Texas, United States, 76092|Fairfax, Virginia, United States, 22031","Alabama|California|Florida|Kansas|Louisiana|Maryland|Massachusetts|Michigan|New York|North Carolina|Tennessee|Texas|Virginia","Australia|Belgium|Bosnia And Herzegovina|Canada|Croatia|Czechia|Georgia|Hungary|Italy|Poland|Serbia|Slovakia|Spain|Turkey|Ukraine|United States","New South Wales Concord Repatriation General Hospital|Saint John Of God Subiaco Hospital|Victoria Ballarat Base Hospital|University Hospital Brussels|Javna Zdravstvena Ustanova Univerzitetski Klinicki Centar Republike Srpske,|Manitoba Winnipeg Regional Health Authority - Health Sciences Centre, Winnipeg|Ontario HÃ´pital Montfort|Hrvatska Klinicki Bolnicki Centar Sestre Milosrdnice|Klinicki Bolnicki Centar Rijeka, Odjel Za Gastroenterologiju|Lekarna Altea|The First University Clinic Of Tsmu|Bekes Megyei Kozponti Korhaz, Rethy Pal Tagkorhaz|A.O.U. Policlinico G. Martino|Bs A.O.Spedali Civili|Cz Univ. \"Magna Graecia\" Di Catanzaro|Milano Asst Rhodense - Ospedale Di Circolo Di Rho|Niepubliczny Zaklad Opieki Zdrowotnej All-Medicus|Silesia H-T. Centrum Medyczne-Endoterapia|Beograd Klinicko Bolnicki Centar \"Bezanijska Kosa\"|Klinicko Bolnicki Centar Zvezdara, Klinika Za Interne Bolesti,|Srbija Klinicki Centar Srbije, Klinika Za Gastroenterohepatologiju|Fakultna Nemocnica S Poliklinikou F.D. Roosevelta Banska Bystrica|Cantabria Hospital Universitario Marques De Valdecilla|Hospital Universitario Virgen De Las Nieves De Granada|Ankara Universitesi Tip Fakultesi, Ibn-I Sina Hastanesi, Ic Hastaliklari Anabilim Dali,|Regional Municipal Institution \"Chernivtsi Regional Clinical Hospital\", Gastroenterology Department,|Dothan Surgery Center|Brighton Surgical Center|Gastro Florida|Westglen Gastrointestinal Consultants, P.A.|Cronola, Llc|Chevy Chase Endoscopy Center|Brigham And Women's Hospital|Caro Health Plaza|Weill Cornell Medical College (Clinical Site)|Unc Hospitals|Holston Medical Group (Drug Shipment Only)|Cross Timbers Surgery Center L.P. (Colonoscopy)|Verity Research, Inc.",{"$nulls":3},"Pfizer CT.gov Call Center","2018-12-07","2020-05-25T16:36:03.639","2020-05-26T17:10:42.972","NCT03395184"]
["5ecbf3f3307e3d1b1f8d9c9b","NCT03395184","2019-01-10","Pfizer","PFE","Recruiting","Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PFâ€‘06700841 In Subjects With Moderate To Severe Crohn's Disease","Brepocitinib|Pf-06651600","JAK1 Inhibitor|TYK2 Inhibitor|JAK1 Inhibitor|JAK3 Inhibitor","Yes","['Brepocitinib', 'Pf-06651600']","Yes","['TYK2 Inhibitor', 'JAK3 Inhibitor']","Phase 2",2,250,"Anticipated","2018-02-02","2020-02-04","DAS","Disease Activity Score",{"$nulls":3},"The objectives of this study are to evaluate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-06651600 (200 mg for 8 weeks followed by 50 mg for 4 weeks) dosed once daily and PF-06700841 (60 mg for 12 weeks) dosed once daily during an induction period of 12 weeks, followed by an open label extension period at doses of 50 mg and 30 mg of PF 06651600 and PF 06700841, respectively, for 52 weeks.",null,"A PHASE 2A, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ORAL PF-06651600 AND PF-06700841 AS INDUCTION AND OPEN LABEL EXTENSION TREATMENT IN SUBJECTS WITH MODERATE TO SEVERE CROHN'S DISEASE","B7981007","Crohn's Disease","Crohn Disease","Gastrointestinal Diseases","Gastrointestinal","Experimental","PF-06700841 or placebo|PF-06651600 or placebo",null,"Drug","Placebo PF-06700841|PF-06700841|Placebo PF-06651600|PF-06651600","12 weeks, followed by PF-06700841, 30 mg QD for 52 weeks.|60 mg QD for 12 weeks followed by 30 mg QD for up to 52 weeks|12 weeks, followed by PF-06651600, 50 mg QD for 52 weeks|200 mg QD for 8 weeks, followed by 50 mg QD up to 56 weeks",null,"PF-06700841 or placebo|PF-06651600 or placebo","\n\n 1. Male and/or female subjects 18 years to 75 years of age\n 2. Documented diagnosis of ileal, ileocolonic, or colonic CD with a minimum disease duration of 3 months, as determined by endoscopic and histopathology assessment.\n 3. Endoscopic confirmation of active disease with total SES CD total score of at least 7. For isolated ileal disease, SES CD total score should be at least 4.\n 4. An average daily liquid/soft stool frequency (SF) greater than or equal to 2.5 or daily abdominal pain (AP) greater than or equal to 2.0.\n 5. Must have inadequate response to, loss of response to, or intolerance to at least one conventional therapy for CD:â€¢Steroids; Immunosuppressants (azathioprine [AZA], 6 MP, or methotrexate [MTX]); Anti TNF inhibitors (infliximab, adalimumab,certolizumab); Anti integrin inhibitors (eg, vedolizumab); Anti IL 12/23 inhibitor (ustekinumab).\n    \n    \n 6. Subjects currently receiving the following treatment for CD are eligible providing they have been on stable doses as described below: * Oral corticosteroids (prednisone or equivalent up to 25 mg/day; budesonide up to 9 mg/day). Stable dose for at least 2 weeks prior to baseline. If oral corticosteroids have been recently discontinued, they must have been stopped at least 2 weeks prior to baseline. Decreases in steroid use due to AEs are allowed.\n     * Oral 5 ASA or sulfasalazine are allowed providing that the dose is stable for at least 4 weeks prior to baseline.\n     * Crohn's disease related antibiotics are allowed providing that the dose is stable for at least 4 weeks prior to baseline. If antibiotics are stopped prior to baseline, they must be discontinued at least 4 days prior to baseline.\n    \n    \n\n","\n\n 1.  Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, diverticular disease, ulcerative colitis (UC), or clinical findings suggestive of UC.\n 2.  Presence of active (draining) fistulae or intra abdominal or perineal abscesses.\n 3.  Strictures with obstructive symptoms.\n 4.  Short bowel syndrome.\n 5.  History of bowel perforation requiring surgical intervention within the past 12 months.\n 6.  Previous bowel surgery resulting in an existing stoma. Subjects who have a j pouch are excluded, as a j pouch can result in a stoma.\n 7.  History of bowel surgery within 6 months prior to baseline.\n 8.  Subjects displaying clinical signs of fulminant colitis or toxic megacolon.\n 9.  Subjects with primary sclerosing cholangitis.\n 10. Subjects with evidence of colonic adenomas, dysplasia or neoplasia.\n 11. Abnormal findings on the chest x ray film such as presence of tuberculosis (TB), general infections, heart failure, or malignancy.\n 12. Any history of either untreated or inadequately treated latent or active TB infection, current treatment for active or latent TB infection or evidence of currently active TB by chest x ray, residing with or frequent close contact with individual(s) with active TB.\n 13. Subjects receiving the following therapies within the time period described below or expected to receive any of these therapies during the study period: 1.  >9 mg/day of oral budesonide or >25 mg/day of prednisone or equivalent oral systemic corticosteroid dose within 2 weeks prior to baseline.\n      2.  IV, IM (parenteral), or topical (rectal) treatment of 5 ASA or corticosteroid enemas/suppositories within 2 weeks prior to baseline.\n      3.  Azathioprine, 6 mercaptopurine, or methotrexate within 2 weeks prior to baseline.\n      4.  Anti TNF inhibitors (or biosimilars thereof) as described below: * Infliximab within 8 weeks prior to baseline;\n           * Adalimumab within 8 weeks prior to baseline;\n           * Certolizumab within 8 weeks prior to baseline;\n          \n          \n      5.  Anti integrin inhibitors (eg, vedolizumab) within 8 weeks prior to baseline.\n      6.  Ustekinumab within 8 weeks prior to baseline.\n      7.  Interferon therapy within 8 weeks prior to baseline.\n      8.  Subjects with prior treatment with lymphocyte depleting agents/therapies within 1 year prior to baseline (eg, CamPath[alemtuzumab], alkylating agents [eg, cyclophosphamide or chlorambucil], total lymphoid irradiation, etc).\n      9.  Subjects who have received rituximab or other selective B lymphocyte depleting agents within 1 year prior to baseline.\n      10. Subjects previously receiving leukocyte apheresis, including selective lymphocyte, monocyte, or granulocyte apheresis, or plasma exchange within 6 months prior to baseline.\n      11. Other marketed immunosuppressants or biologics with immunomodulatory properties within 3 months prior to baseline.\n      12. Subjects who have received other JAK inhibitors within 3 months prior to baseline.\n      13. Subjects who have not responded to or have been intolerant of other JAK inhibitors.\n      14. Other investigational procedures(s) or product(s), such as immunosuppressants used in transplantation (eg, mycophenolate mofetil, cyclosporine, rapamycin, or tacrolimus) or live (attenuated) vaccine within 30 days prior to baseline.","TNF","tumor necrosis factor","Protein","Lung, Breast, Ovary","Actual","2018-01-10","Actual","Anticipated","2021-02-18","Anticipated","2019-01-01","2017-12-05","2018-01-03","2019-01-08","Yes",null,"Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years","75 Years","All",null,"No","Yes\nPfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",null,"URL: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7981007&StudyName=A+Phase+2a%2C+Double-blind%2C+Randomized%2C+Placebo-controlled%2C+Parallel+Group+Study+To+Evaluate+The+Efficacy+And+Safety+Of+Oral+Pf-06651600+And+Pf-06700841+As+Induction+And+Open+Label+Extension+Treatment+In+Subjects+With+Moderate+To+Severe+Crohn%E2%80%99s+Disease [https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7981007&StudyName=A+Phase+2a%2C+Double-blind%2C+Randomized%2C+Placebo-controlled%2C+Parallel+Group+Study+To+Evaluate+The+Efficacy+And+Safety+Of+Oral+Pf-06651600+And+Pf-06700841+As+Induction+And+Open+Label+Extension+Treatment+In+Subjects+With+Moderate+To+Severe+Crohn%E2%80%99s+Disease] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To obtain contact information for a study center near you, click here.",null,"Yes","No",{"$nulls":17},"2017-003359-43|PIZZICATO","EudraCT Number|Alias Study Number","Proportion of subjects achieving clinically meaningful endoscopic improvement (reduction of more than or equal to 3 points from baseline in Simplified Endoscopic Activity Score for Crohn's Disease (SES-CD) at Week 12","12 weeks",null,"Number of participants with potentially clinically important serious infections findings|Mean change from baseline in SES-CD score at Week 12.|Proportion of subjects achieving SES-CD 25 and SES-CD 50 at Week 12.|Proportion of subjects achieving endoscopic remission (SES-CD less than or equal to 2) at Week 12.|Proportion of subjects achieving mucosal healing at Week 12.|Number of subjects with adverse events|Number of subjects with serious adverse events|Number of subjects with electrocardiogram findings of potential clinical importance.|Number of subjects withdrawal due to adverse events|Number of subjects with vital signs findings of potential clinical importance.|Number of subjects with laboratory tests findings of potential clinical importance.|Proportion of subjects achieving SES CD 25 and SES CD 50 at Week 64 among subjects who achieved SES CD 25 and SES CD 50 at week 12 respectively.|Proportion of subjects achieving clinically meaningful endoscopic improvement (CMEI response) at week 64 among subjects who achieved CMEI response at Week 12.","64 weeks|Baseline, week 12|Number of subjects achieving SES-CD 25 and SES-CD 50 at Week 12.|Number of subjects achieving endoscopic remission (SES-CD less than or equal to 2) at Week 12.|Number of subjects achieving mucosal healing at Week 12.|Number of participants with reported adverse events|Number of participants with reported serious adverse events|Number of participants with potentially clinically important electrocardiogram findings.|Number of subjects withdrawal due to adverse events.|Number of participants with potentially clinically important vital signs findings.|Number of participants with potentially clinically important laboratory findings.|Number of subjects achieving SES-CD 25 and SES-CD 50 at Week 64 among subjects who achieved SES CD 25 and SES CD 50 at week 12|Number of subject achieving clinically meaningful endoscopic improvement (CMEI response) at week 64 among subjects who achieved CMEI response at week 12.","Baseline, week 12|Week 12|Baseline up to 64 weeks|Baseline u to 64 weeks|week 64","ClinicalTrials.gov_Inquiries@pfizer.com","Pfizer CT.gov Call Center","1-800-718-1021","Concord, New South Wales, Australia, 2139|South Brisbane, Queensland, Australia, 4101|Subiaco, Western|Ballarat, Victoria, Australia, 3350|Jette, Belgium, 1090 University Hospitals LeuvenLeuven, Belgium, 3000 Chc - Saint-JosephLiÃ¨ge, Belgium, 4000|Banja Luka, Bosnia And Herzegovina, 78000 Sveucilisna Klinicka Bolnica Mostar,Mostar, Bosnia And Herzegovina, 88000|Winnipeg, Manitoba, Canada, R3A 1R9|Ottawa, Ontario, Canada, K1K 0T2|Zagreb, Hrvatska, Croatia, 10000|Rijeka, Croatia, 51000 Klinicki Bolnicki Centar Split, Zavod Za GastroenterologijuSplit, Croatia, 21000 Opca Bolnica Zadar, Odjel Za GastroenterologijuZadar, Croatia, 23000 Klinicka Bolnica Dubrava ZagrebZagreb, Croatia, 10000 Klinicki Bolnicki Centar Zagreb, Zavod Za Gastroenterologiju I HepatologijuZagreb, Croatia, 10000|Bilina, Czechia, 41801 Nemocnice Horovice, A.S.Horovice, Czechia, 268 31 Hepato-Gastroenterologie Hk S.R.O.Hradec Kralove, Czechia, 500 12 Medialpharma S.R.O.Hradec Kralove, Czechia, 500 12 Gastroenterologicka Ambulance A EndoskopieMost, Czechia, 43401 Artroscan, S.R.O., Gastroenterologicke OddeleniOstrava, Czechia, 722 00 Lekarna U VitkaOstrava, Czechia, 722 00 Vseobecna Fakultni NemocnicePraha 2, Czechia, 128 08 VÅ¡eobecnÃ¡ FakultnÃ­ Nemocnice V PrazePraha 2, Czechia, 128 08 Nemocnice Strakonice, A.S., Interni OddeleniStrakonice, Czechia, 386 01 Nemocnice Strakonice, A.S.Strakonice, Czechia, 386 29|Achrafieh, Beirut, Lebanon|Tbilisi, Georgia, 0141 David Tatishvili Medical CenterTbilisi, Georgia, 0186|Bekescsaba, Hungary, 5600 Semmelweis Egyetem, Ii. Belgyogyaszati KlinikaBudapest, Hungary, 1088 Szent Janos Korhaz Es Eszak-Budai Egyesitett KorhazakBudapest, Hungary, 1125 Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz, Endoszkopos LaboratoriumGyula, Hungary, 5700 Clinfan Szolgaltato Kft.Szekszard, Hungary, 7100 Csolnoky Ferenc Korhaz Belgyogyaszati Centrum I. Belgyogyaszati OsztalyVeszprem, Hungary, 8200|Messina, Italy, 98125 Istituto Clinico Humanitas Irccs - Ibd CenterMilan, Italy, 20089 Aou Policlinico Di ModenaModena, Italy, 41124 Azienda Ospedaliera Di PadovaPadova, Italy, 35128 Policlinico Universitario Campus Bio-MedicoRoma, Italy, 00128 Policlinico Gemelli/Complesso Integrato ColumbusRome, Italy, 00168 Korea, Republic Of, Korea Kyungpook National University HospitalDaegu, Korea, Korea, Republic Of, 41944 Korea, Republic Of Kangbuk Samsung HospitalSeoul, Korea, Republic Of, 03181 Severance Hospital, Yonsei University Health SystemSeoul, Korea, Republic Of, 03722 The Catholic University Of Korea, Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591|Castellana Grotte, Bari, Italy, 70013|Brescia, Bs, Italy, 25123|Catanzaro, Cz, Italy, 88100|Rho, Milano, Italy, 20017|Jbeil, Lebanon|Katowice, Poland, 40-659 Etg KielceKielce, Poland, 25-355 Indywidualna Specjalstyczna Praktyka Lekarska Maciej ZymlaKnurow, Poland, 44-190 Szpital W Knurowie Sp. Z O.O.Knurow, Poland, 44-190 Centrum Badan Klinicznych JciKrakow, Poland, 30-348 Marta Dagmara Banach Marta Banach Specjalistyczny Gabinet NeurologicznyKrakow, Poland, 30-539 Centrum Medyczne EvitaKrakow, Poland, 31-153 Szpital Specjalistyczny Im. Ludwika Rydygiera W Krakowie Sp. Z O.O.Krakow, Poland, 31-826 Centrum Medyczne Szpital Swietej Rodziny Sp Z O.O.Lodz, Poland, 90-302 Pracownia Endoskopii Centrum Medyczne Szpital Swietej Rodziny Sp Z O.O.Lodz, Poland, 90-302 Medical Magnus ClinicLodz, Poland, 90-552 Wojewodzki Szpital Specjalistyczny Im. Bieganskiego W LodziLodz, Poland, 91-347 Gastromed Sp. Z O.O.Lublin, Poland, 20-582 Ai Centrum Medyczne Sp. Z O.O. Sp.K.Poznan, Poland, 61-113 Korczowski Bartosz Gabinet LekarskiRzeszow, Poland, 35-302 Endoskopia Sp. Z O. O.Sopot, Poland, 81-756 Szpital Sredzki Serca Jezusowego Sp. Z O.O.Sroda Wielkopolska, Poland, 63-000 Ez-Med Sp. Z O.O. Sp.K.Swidnica, Poland, 58-100 Pracownia Endoskopii Szpital MswSzczecin, Poland, 70-001 Twoja Przychodnia Szczecinskie Centrum MedyczneSzczecin, Poland, 71-270 Gastromed Kopon, Zmudzinski I Wspolnicy Sp.J.Torun, Poland, 87-100 Centrum Zdrowia MdmWarszawa, Poland, 00-635 Centrum Diagnostyczno-Lecznicze Barska Sp. Z O. O.Wloclawek, Poland, 87-800 Melita Medical Sp. Z O.O.Wroclaw, Poland, 50-449 Centrum Gastrologiczno HepatologiczneWroclaw, Poland, 50-555 LexmedicaWroclaw, Poland, 53-114 Russian Federation, Sestroretsk Spb Sbih \"City Hospital #40 Of The Kurortnyi Region\"Saint-Petersburg, Sestroretsk, Russian Federation, 197706 Russian Federation Llc \"Alliance Biomedical-Ural Group\"Izhevsk, Russian Federation, 426061 Clinic Of Fsbei He Ksmu Moh RfKrasnodar, Russian Federation, 350072 Llc \"Olla-Med\"Moscow, Russian Federation, 105554 Sechenov University On The Base Of Institute Of Translational Medicine And BiotechnologyMoscow, Russian Federation, 119435 Limited Liability Company \"Medical Center Sibnovomed\"Novosibirsk, Russian Federation, 630005 Federal State Budgetary Scientific Institution \"Scientific Research Institute Of Physiology AndNovosibirsk, Russian Federation, 630117 Clinic At Fsbei He \"Omsk State Medical University\" Moh RfOmsk, Russian Federation, 644050 Llc \"New Clinic\"Pyatigorsk, Russian Federation, 357500 Limited Liability Company \"Riat\"Saint-Petersburg, Russian Federation, 195220 Saint-Petersburg State Budgetary Healthcare Institution \"City Hospital #26\"Saint-Petersburg, Russian Federation, 196247 Private Institution Educational Organization Of Higher EducationSamara, Russian Federation, 443011 Non-State Healthcare Institution 'Railway Clinical Hospital At Samara Station Of Open Joint StockSamara, Russian Federation, 443029 Saint-Petersburg State Budgetary Healthcare Institution \"City Clinical Hospital Of The RighteousSt. Petersburg, Russian Federation, 197706|Tychy, Silesia, Poland, 43-100|Zemun, Beograd, Serbia, 11080|Beograd, Serbia, 11000 Klinicko Bolnicki Centar Zemun, Klinika Za Internu Medicinu,Zemun, Beograd, Serbia, 11080|Beograd, Srbija, Serbia, 11000 Klinicki Centar KragujevacKragujevac, Srbija, Serbia, 34000 Klinicki Centar NisNis, Srbija, Serbia, 18000 Opsta Bolnica SuboticaSubotica, Srbija, Serbia, 24000 Opsta Bolnica \"Djordje Joanovic\", Odeljenje Interno, Odsek GastroenterologijaZrenjanin, Srbija, Serbia, 23000|Banska Bystrica, Slovakia, 975 17 Breznianske Centrum Gastroenterologie S.R.O.Brezno, Slovakia, 97701 Km Management Spol. S.R.O.Nitra, Slovakia, 949 01 Accout Center S.R.O. Gastroenterologicka AmbulanciaSahy, Slovakia, 936 01 Endomed, S.R.O.Vranov Nad Toplou, Slovakia, 093 01|Santander, Cantabria, Spain, 39008|Granada, Spain, 18014 Hospital Universitario Ramon Y CajalMadrid, Spain, 28034 Hospital Universitario Virgen Del RocioSevilla, Spain, 41013 Hospital Universitari I Politecnic La FeValencia, Spain, 46026|Tunis, Tunisia, 1008|Ankara, Turkey, 06100 Ankara Universitesi Tip Fakultesi, Ibn-I Sina HastanesiAnkara, Turkey, 06100 Hacettepe Universitesi Tip FakultesiAnkara, Turkey, 06230 Bezmialem Vakif Universitesi Tip Fakultesi HastanesiIstanbul, Turkey, 34093 Istanbul Universitesi Cerrahpasa Tip FacultesiIstanbul, Turkey, 34098 Istanbul Universitesi Cerrahpasa Tip FakultesiIstanbul, Turkey, 34098 Erciyes Universitesi Tip FakultesiKayseri, Turkey, 38039 Kocaeli Universitesi Tip FakultesiKocaeli, Turkey, 41380 Mersin Universitesi Tip Fakultesi Hastanesi, Ic HastaliklariMersin, Turkey, 33110 Mersin Universitesi Tip Fakultesi HastanesiMersin, Turkey, 33110 Karadeniz Teknik Universitesi Tip Fakultesi, Ic HastaliklariTrabzon, Turkey, 61080 Karadeniz Teknik Universitesi Tip FakultesiTrabzon, Turkey, 61080 Bulent Ecevit Universitesi Tip FakultesiZonguldak, Turkey, 67600|Chernivtsi, Ukraine, 58001 Regional Municipal Institution \"Chernivtsi Regional Clinical Hospital\", Surgery DepartmentChernivtsi, Ukraine, 58001 Traumatology And Orthopedic Center LlcChernivtsi, Ukraine, 58023 Municipal Healthcare Institution Kharkiv City Clinical Hospital #2 N.A. Prof. O.O. ShalimovKharkiv, Ukraine, 61037 Private Enterprise Of Private Manufacturing Company \"Acinus\", Medical And Diagnostic CenterKropyvnytskyi, Ukraine, 25006 Kyiv Municipal Clinical Hospital #18, Proctology DepartmentKyiv, Ukraine, 01030 Medical Center \"Universal Clinic Oberig\" Of \"Kapital\" Llc, Gastro CenterKyiv, Ukraine, 03680 Lviv Clinical Hospital On Railway Transport Of Health Care Center Branch Of Pjsc Ukrainian RailwayLviv, Ukraine, 79007 Vinnytsia City Clinical Hospital No.1Vinnytsia, Ukraine, 21000 Private Small-Scale Enterprise Medical Center \"Pulse\"Vinnytsia, Ukraine, 21001 Vinnytsia Regional Clinical Hospital For War VeteransVinnytsia, Ukraine, 21005 Vinnytsia Regional Clinical Hospital N.A. M.I.PyrohovVinnytsia, Ukraine, 21018|Dothan, Alabama, United States, 36301 Gut P.C., Dba Digestive Health Specialists Of The SoutheastDothan, Alabama, United States, 36305|Beverly Hills, California, United States, 90210 Long Beach Clinical Trial Services, Inc.Long Beach, California, United States, 90806 Entertainment Medical GroupLos Angeles, California, United States, 90036 Gastrointestinal Biosciences Clinical Trials, LlcLos Angeles, California, United States, 90067 Alliance Clinical Research, LlcPoway, California, United States, 92064|Clearwater, Florida, United States, 33756-3839 West Coast Endoscopy CenterClearwater, Florida, United States, 33756 Gastro FloridaClearwater, Florida, United States, 33762 University Of Miami Clinical Research BuildingMiami, Florida, United States, 33136 University Of Miami Crohn'S And Colitis CenterMiami, Florida, United States, 33136 University Of Miami Hospital And ClinicsMiami, Florida, United States, 33136 University Of Miami HospitalMiami, Florida, United States, 33136 Millenia Surgery CenterOrlando, Florida, United States, 32811 Hmd Research LlcOrlando, Florida, United States, 32819 Orlando Gastroenterology, PaOrlando, Florida, United States, 32835|Shawnee Mission, Kansas, United States, 66217|Houma, Louisiana, United States, 70360 Gulf Coast Surgical CenterHouma, Louisiana, United States, 70360 The Hearing Center (Audiology)Houma, Louisiana, United States, 70360|Chevy Chase, Maryland, United States, 20815 Mgg Group Co., Inc., Chevy Chase Clinical ResearchChevy Chase, Maryland, United States, 20815|Boston, Massachusetts, United States, 02115 Mass Eye And Ear, LongwoodBoston, Massachusetts, United States, 02115 Brigham And Women'S HospitalChestnut Hill, Massachusetts, United States, 02467 Umass Memorial Medical CenterWorcester, Massachusetts, United States, 01655 University Of Massachusetts Medical SchoolWorcester, Massachusetts, United States, 01655|Caro, Michigan, United States, 48723 Clinical Research Institute Of Michigan, LlcChesterfield, Michigan, United States, 48047 Eastside Endoscopy CenterMacomb, Michigan, United States, 48044 Eastside Endoscopy CenterSaint Clair Shores, Michigan, United States, 48081|New York, New York, United States, 10021 New York Presbyterian Hospital - Weill Cornell Medical College (Colonoscopy)New York, New York, United States, 10065 New York Presbyterian Hospital - Weill Cornell Medical College Investigational PharmacyNew York, New York, United States, 10065 Weill Cornell Medical College - New York Presbyterian Hospital (Endoscopy Suite)New York, New York, United States, 10065 Weill Cornell Medical College - New York Presbyterian HospitalNew York, New York, United States, 10065 Digiovanna Institute For Medical Education And ResearchNorth Massapequa, New York, United States, 11758-1853|Chapel Hill, North Carolina, United States, 27514 Unc Hospitals Endoscopy Center At MeadowmontChapel Hill, North Carolina, United States, 27517 University Of North Carolina At Chapel HillChapel Hill, North Carolina, United States, 27599 Gastroenterology Associates Of The Piedmont, PaWinston-Salem, North Carolina, United States, 27103 Pmg Research Of Winston-Salem, LlcWinston-Salem, North Carolina, United States, 27103|Kingsport, Tennessee, United States, 37660 Holston Valley Surgery CenterKingsport, Tennessee, United States, 37660 Vanderbilt University Medical CenterNashville, Tennessee, United States, 37212-1375 Vanderbilt University Medical CenterNashville, Tennessee, United States, 37212-1610 Vanderbilt University Medical Center - Gi Endoscopy LabNashville, Tennessee, United States, 37232-5543 Vanderbilt University Medical CenterNashville, Tennessee, United States, 37232-7610 Vanderbilt University Medical Center - Gi Research RegulatoryNashville, Tennessee, United States, 37232|Arlington, Texas, United States, 76012 Envision Imaging (Cxr)Arlington, Texas, United States, 76012 Texas Clinical Research Institiute, LlcArlington, Texas, United States, 76012 Hermann Drive Surgical HospitalHouston, Texas, United States, 77004 Pearland Surgery CenterHouston, Texas, United States, 77047 Gulf Coast Research Group, LlcHouston, Texas, United States, 77098 North Texas Research AssociatesMckinney, Texas, United States, 75069 Lonestar Endoscopy, LlpSouthlake, Texas, United States, 76092 Texas Digestive Disease ConsultantsSouthlake, Texas, United States, 76092|Fairfax, Virginia, United States, 22031","Alabama|California|Florida|Kansas|Louisiana|Maryland|Massachusetts|Michigan|New York|North Carolina|Tennessee|Texas|Virginia","Australia|Belgium|Bosnia And Herzegovina|Canada|Croatia|Czechia|France|Georgia|Hungary|Italy|Lebanon|Poland|Serbia|Slovakia|Spain|Tunisia|Turkey|Ukraine|United States","New South Wales Concord Repatriation General Hospital|Queensland Mater Misericordiae Ltd|Saint John Of God Subiaco Hospital|Victoria Ballarat Base Hospital|University Hospital Brussels|Javna Zdravstvena Ustanova Univerzitetski Klinicki Centar Republike Srpske,|Manitoba Winnipeg Regional Health Authority - Health Sciences Centre, Winnipeg|Ontario HÃ´pital Montfort|Hrvatska Klinicki Bolnicki Centar Sestre Milosrdnice|Klinicki Bolnicki Centar Rijeka, Odjel Za Gastroenterologiju|Lekarna Altea|Hospital|The First University Clinic Of Tsmu|Bekes Megyei Kozponti Korhaz, Rethy Pal Tagkorhaz|A.O.U. Policlinico G. Martino|Bari Istituto Di Ricovero E Cura A Carattere Scientifico (Ircss) S. De Bellis|Bs A.O.Spedali Civili|Cz Univ. \"Magna Graecia\" Di Catanzaro|Milano Asst Rhodense - Ospedale Di Circolo Di Rho|Centre Hospitalier Universitaire Notre Dame De Secours|Niepubliczny Zaklad Opieki Zdrowotnej All-Medicus|Silesia H-T. Centrum Medyczne-Endoterapia|Beograd Klinicko Bolnicki Centar \"Bezanijska Kosa\"|Klinicko Bolnicki Centar Zvezdara, Klinika Za Interne Bolesti,|Srbija Klinicki Centar Srbije, Klinika Za Gastroenterohepatologiju|Fakultna Nemocnica S Poliklinikou F.D. Roosevelta Banska Bystrica|Cantabria Hospital Universitario Marques De Valdecilla|Hospital Universitario Virgen De Las Nieves De Granada|Habib Thameur Hospital|Ankara Universitesi Tip Fakultesi, Ibn-I Sina Hastanesi, Ic Hastaliklari Anabilim Dali,|Regional Municipal Institution \"Chernivtsi Regional Clinical Hospital\", Gastroenterology Department,|Dothan Surgery Center|Brighton Surgical Center|Gastro Florida|Westglen Gastrointestinal Consultants, P.A.|Cronola, Llc|Chevy Chase Endoscopy Center|Brigham And Women's Hospital|Caro Health Plaza|Weill Cornell Medical College (Clinical Site)|Unc Hospitals|Holston Medical Group|Cross Timbers Surgery Center L.P. (Colonoscopy)|Verity Research, Inc.",{"$nulls":3},"Pfizer CT.gov Call Center","2019-01-08","2020-05-25T16:36:03.755","2020-05-26T17:10:42.972","NCT03395184"]
["5ecbf3f3feab101b1553083a","NCT03395184","2019-02-15","Pfizer","PFE","Recruiting","Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PFâ€‘06700841 In Subjects With Moderate To Severe Crohn's Disease","Brepocitinib|Pf-06651600","JAK1 Inhibitor|TYK2 Inhibitor|JAK1 Inhibitor|JAK3 Inhibitor","Yes","['Brepocitinib', 'Pf-06651600']","Yes","['TYK2 Inhibitor', 'JAK3 Inhibitor']","Phase 2",2,250,"Anticipated","2018-02-02","2020-02-04","DAS","Disease Activity Score",{"$nulls":3},"The objectives of this study are to evaluate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-06651600 (200 mg for 8 weeks followed by 50 mg for 4 weeks) dosed once daily and PF-06700841 (60 mg for 12 weeks) dosed once daily during an induction period of 12 weeks, followed by an open label extension period at doses of 50 mg and 30 mg of PF 06651600 and PF 06700841, respectively, for 52 weeks.",null,"A PHASE 2A, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ORAL PF-06651600 AND PF-06700841 AS INDUCTION AND OPEN LABEL EXTENSION TREATMENT IN SUBJECTS WITH MODERATE TO SEVERE CROHN'S DISEASE","B7981007","Crohn's Disease","Crohn Disease","Gastrointestinal Diseases","Gastrointestinal","Experimental","PF-06700841 or placebo|PF-06651600 or placebo",null,"Drug","Placebo PF-06700841|PF-06700841|Placebo PF-06651600|PF-06651600","12 weeks, followed by PF-06700841, 30 mg QD for 52 weeks.|60 mg QD for 12 weeks followed by 30 mg QD for up to 52 weeks|12 weeks, followed by PF-06651600, 50 mg QD for 52 weeks|200 mg QD for 8 weeks, followed by 50 mg QD up to 56 weeks",null,"PF-06700841 or placebo|PF-06651600 or placebo","\n\n 1. Male and/or female subjects 18 years to 75 years of age\n 2. Documented diagnosis of ileal, ileocolonic, or colonic CD with a minimum disease duration of 3 months, as determined by endoscopic and histopathology assessment.\n 3. Endoscopic confirmation of active disease with total SES CD total score of at least 7. For isolated ileal disease, SES CD total score should be at least 4.\n 4. An average daily liquid/soft stool frequency (SF) greater than or equal to 2.5 or daily abdominal pain (AP) greater than or equal to 2.0.\n 5. Must have inadequate response to, loss of response to, or intolerance to at least one conventional therapy for CD:â€¢Steroids; Immunosuppressants (azathioprine [AZA], 6 MP, or methotrexate [MTX]); Anti TNF inhibitors (infliximab, adalimumab,certolizumab); Anti integrin inhibitors (eg, vedolizumab); Anti IL 12/23 inhibitor (ustekinumab).\n    \n    \n 6. Subjects currently receiving the following treatment for CD are eligible providing they have been on stable doses as described below: * Oral corticosteroids (prednisone or equivalent up to 25 mg/day; budesonide up to 9 mg/day). Stable dose for at least 2 weeks prior to baseline. If oral corticosteroids have been recently discontinued, they must have been stopped at least 2 weeks prior to baseline. Decreases in steroid use due to AEs are allowed.\n     * Oral 5 ASA or sulfasalazine are allowed providing that the dose is stable for at least 4 weeks prior to baseline.\n     * Crohn's disease related antibiotics are allowed providing that the dose is stable for at least 4 weeks prior to baseline. If antibiotics are stopped prior to baseline, they must be discontinued at least 4 days prior to baseline.\n    \n    \n\n","\n\n 1.  Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, diverticular disease, ulcerative colitis (UC), or clinical findings suggestive of UC.\n 2.  Presence of active (draining) fistulae or intra abdominal or perineal abscesses.\n 3.  Strictures with obstructive symptoms.\n 4.  Short bowel syndrome.\n 5.  History of bowel perforation requiring surgical intervention within the past 12 months.\n 6.  Previous bowel surgery resulting in an existing stoma. Subjects who have a j pouch are excluded, as a j pouch can result in a stoma.\n 7.  History of bowel surgery within 6 months prior to baseline.\n 8.  Subjects displaying clinical signs of fulminant colitis or toxic megacolon.\n 9.  Subjects with primary sclerosing cholangitis.\n 10. Subjects with evidence of colonic adenomas, dysplasia or neoplasia.\n 11. Abnormal findings on the chest x ray film such as presence of tuberculosis (TB), general infections, heart failure, or malignancy.\n 12. Any history of either untreated or inadequately treated latent or active TB infection, current treatment for active or latent TB infection or evidence of currently active TB by chest x ray, residing with or frequent close contact with individual(s) with active TB.\n 13. Subjects receiving the following therapies within the time period described below or expected to receive any of these therapies during the study period: 1.  >9 mg/day of oral budesonide or >25 mg/day of prednisone or equivalent oral systemic corticosteroid dose within 2 weeks prior to baseline.\n      2.  IV, IM (parenteral), or topical (rectal) treatment of 5 ASA or corticosteroid enemas/suppositories within 2 weeks prior to baseline.\n      3.  Azathioprine, 6 mercaptopurine, or methotrexate within 2 weeks prior to baseline.\n      4.  Anti TNF inhibitors (or biosimilars thereof) as described below: * Infliximab within 8 weeks prior to baseline;\n           * Adalimumab within 8 weeks prior to baseline;\n           * Certolizumab within 8 weeks prior to baseline;\n          \n          \n      5.  Anti integrin inhibitors (eg, vedolizumab) within 8 weeks prior to baseline.\n      6.  Ustekinumab within 8 weeks prior to baseline.\n      7.  Interferon therapy within 8 weeks prior to baseline.\n      8.  Subjects with prior treatment with lymphocyte depleting agents/therapies within 1 year prior to baseline (eg, CamPath[alemtuzumab], alkylating agents [eg, cyclophosphamide or chlorambucil], total lymphoid irradiation, etc).\n      9.  Subjects who have received rituximab or other selective B lymphocyte depleting agents within 1 year prior to baseline.\n      10. Subjects previously receiving leukocyte apheresis, including selective lymphocyte, monocyte, or granulocyte apheresis, or plasma exchange within 6 months prior to baseline.\n      11. Other marketed immunosuppressants or biologics with immunomodulatory properties within 3 months prior to baseline.\n      12. Subjects who have received other JAK inhibitors within 3 months prior to baseline.\n      13. Subjects who have not responded to or have been intolerant of other JAK inhibitors.\n      14. Other investigational procedures(s) or product(s), such as immunosuppressants used in transplantation (eg, mycophenolate mofetil, cyclosporine, rapamycin, or tacrolimus) or live (attenuated) vaccine within 30 days prior to baseline.","TNF","tumor necrosis factor","Protein","Lung, Breast, Ovary","Actual","2018-01-10","Actual","Anticipated","2021-02-18","Anticipated","2019-02-01","2017-12-05","2018-01-03","2019-02-11","Yes",null,"Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years","75 Years","All",null,"No","Yes\nPfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",null,"URL: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7981007&StudyName=A+Phase+2a%2C+Double-blind%2C+Randomized%2C+Placebo-controlled%2C+Parallel+Group+Study+To+Evaluate+The+Efficacy+And+Safety+Of+Oral+Pf-06651600+And+Pf-06700841+As+Induction+And+Open+Label+Extension+Treatment+In+Subjects+With+Moderate+To+Severe+Crohn%E2%80%99s+Disease [https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7981007&StudyName=A+Phase+2a%2C+Double-blind%2C+Randomized%2C+Placebo-controlled%2C+Parallel+Group+Study+To+Evaluate+The+Efficacy+And+Safety+Of+Oral+Pf-06651600+And+Pf-06700841+As+Induction+And+Open+Label+Extension+Treatment+In+Subjects+With+Moderate+To+Severe+Crohn%E2%80%99s+Disease] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To obtain contact information for a study center near you, click here.",null,"Yes","No",{"$nulls":17},"2017-003359-43|PIZZICATO","EudraCT Number|Alias Study Number","Proportion of subjects achieving clinically meaningful endoscopic improvement (reduction of more than or equal to 3 points from baseline in Simplified Endoscopic Activity Score for Crohn's Disease (SES-CD) at Week 12","12 weeks",null,"Number of participants with potentially clinically important serious infections findings|Mean change from baseline in SES-CD score at Week 12.|Proportion of subjects achieving SES-CD 25 and SES-CD 50 at Week 12.|Proportion of subjects achieving endoscopic remission (SES-CD less than or equal to 2) at Week 12.|Proportion of subjects achieving mucosal healing at Week 12.|Number of subjects with adverse events|Number of subjects with serious adverse events|Number of subjects with electrocardiogram findings of potential clinical importance.|Number of subjects withdrawal due to adverse events|Number of subjects with vital signs findings of potential clinical importance.|Number of subjects with laboratory tests findings of potential clinical importance.|Proportion of subjects achieving SES CD 25 and SES CD 50 at Week 64 among subjects who achieved SES CD 25 and SES CD 50 at week 12 respectively.|Proportion of subjects achieving clinically meaningful endoscopic improvement (CMEI response) at week 64 among subjects who achieved CMEI response at Week 12.","64 weeks|Baseline, week 12|Number of subjects achieving SES-CD 25 and SES-CD 50 at Week 12.|Number of subjects achieving endoscopic remission (SES-CD less than or equal to 2) at Week 12.|Number of subjects achieving mucosal healing at Week 12.|Number of participants with reported adverse events|Number of participants with reported serious adverse events|Number of participants with potentially clinically important electrocardiogram findings.|Number of subjects withdrawal due to adverse events.|Number of participants with potentially clinically important vital signs findings.|Number of participants with potentially clinically important laboratory findings.|Number of subjects achieving SES-CD 25 and SES-CD 50 at Week 64 among subjects who achieved SES CD 25 and SES CD 50 at week 12|Number of subject achieving clinically meaningful endoscopic improvement (CMEI response) at week 64 among subjects who achieved CMEI response at week 12.","Baseline, week 12|Week 12|Baseline up to 64 weeks|Baseline u to 64 weeks|week 64","ClinicalTrials.gov_Inquiries@pfizer.com","Pfizer CT.gov Call Center","1-800-718-1021","Concord, New South Wales, Australia, 2139|South Brisbane, Queensland, Australia, 4101|Subiaco, Western|Ballarat, Victoria, Australia, 3350|Jette, Belgium, 1090 University Hospitals LeuvenLeuven, Belgium, 3000 Chc - Saint-JosephLiÃ¨ge, Belgium, 4000|Banja Luka, Bosnia And Herzegovina, 78000 Sveucilisna Klinicka Bolnica Mostar,Mostar, Bosnia And Herzegovina, 88000|Winnipeg, Manitoba, Canada, R3A 1R9|Ottawa, Ontario, Canada, K1K 0T2|Zagreb, Hrvatska, Croatia, 10000|Rijeka, Croatia, 51000 Klinicki Bolnicki Centar Split, Zavod Za GastroenterologijuSplit, Croatia, 21000 Opca Bolnica Zadar, Odjel Za GastroenterologijuZadar, Croatia, 23000 Klinicka Bolnica Dubrava ZagrebZagreb, Croatia, 10000 Klinicki Bolnicki Centar Zagreb, Zavod Za Gastroenterologiju I HepatologijuZagreb, Croatia, 10000|Bilina, Czechia, 41801 Nemocnice Horovice, A.S.Horovice, Czechia, 268 31 Hepato-Gastroenterologie Hk S.R.O.Hradec Kralove, Czechia, 500 12 Medialpharma S.R.O.Hradec Kralove, Czechia, 500 12 Gastroenterologicka Ambulance A EndoskopieMost, Czechia, 43401 Artroscan, S.R.O., Gastroenterologicke OddeleniOstrava, Czechia, 722 00 Lekarna U VitkaOstrava, Czechia, 722 00 Vseobecna Fakultni NemocnicePraha 2, Czechia, 128 08 VÅ¡eobecnÃ¡ FakultnÃ­ Nemocnice V PrazePraha 2, Czechia, 128 08 Nemocnice Strakonice, A.S., Interni OddeleniStrakonice, Czechia, 386 01 Nemocnice Strakonice, A.S.Strakonice, Czechia, 386 29|Achrafieh, Beirut, Lebanon|Tbilisi, Georgia, 0141 David Tatishvili Medical CenterTbilisi, Georgia, 0186|Berlin, Germany, 10318 Universitaetsklinikum BonnBonn, Germany, 53127|Bekescsaba, Hungary, 5600 Semmelweis Egyetem, Ii. Belgyogyaszati KlinikaBudapest, Hungary, 1088 Szent Janos Korhaz Es Eszak-Budai Egyesitett KorhazakBudapest, Hungary, 1125 Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz, Endoszkopos LaboratoriumGyula, Hungary, 5700 Clinfan Szolgaltato Kft.Szekszard, Hungary, 7100 Csolnoky Ferenc Korhaz Belgyogyaszati Centrum I. Belgyogyaszati OsztalyVeszprem, Hungary, 8200|Messina, Italy, 98125 Istituto Clinico Humanitas Irccs - Ibd CenterMilan, Italy, 20089 Aou Policlinico Di ModenaModena, Italy, 41124 Azienda Ospedaliera Di PadovaPadova, Italy, 35128 Policlinico Universitario Campus Bio-MedicoRoma, Italy, 00128 Policlinico Gemelli/Complesso Integrato ColumbusRome, Italy, 00168 Korea, Republic Of, Korea Kyungpook National University HospitalDaegu, Korea, Korea, Republic Of, 41944 Korea, Republic Of Kangbuk Samsung HospitalSeoul, Korea, Republic Of, 03181 Severance Hospital, Yonsei University Health SystemSeoul, Korea, Republic Of, 03722 The Catholic University Of Korea, Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591|Castellana Grotte, Bari, Italy, 70013|Brescia, Bs, Italy, 25123|Catanzaro, Cz, Italy, 88100|Monza, Mb, Italy, 20090|Rho, Milano, Italy, 20017|Beirut, Lebanon Ain Wazein Medical VillageEl Chouf, Lebanon Centre Hospitalier Universitaire Notre Dame De SecoursJbeil, Lebanon Hammoud Hospital University Medical CenterSaida, Lebanon|Katowice, Poland, 40-659 Etg KielceKielce, Poland, 25-355 Indywidualna Specjalstyczna Praktyka Lekarska Maciej ZymlaKnurow, Poland, 44-190 Szpital W Knurowie Sp. Z O.O.Knurow, Poland, 44-190 Centrum Badan Klinicznych JciKrakow, Poland, 30-348 Marta Dagmara Banach Marta Banach Specjalistyczny Gabinet NeurologicznyKrakow, Poland, 30-539 Centrum Medyczne EvitaKrakow, Poland, 31-153 Szpital Specjalistyczny Im. Ludwika Rydygiera W Krakowie Sp. Z O.O.Krakow, Poland, 31-826 Centrum Medyczne Szpital Swietej Rodziny Sp Z O.O.Lodz, Poland, 90-302 Pracownia Endoskopii Centrum Medyczne Szpital Swietej Rodziny Sp Z O.O.Lodz, Poland, 90-302 Medical Magnus ClinicLodz, Poland, 90-552 Wojewodzki Szpital Specjalistyczny Im. Bieganskiego W LodziLodz, Poland, 91-347 Gastromed Sp. Z O.O.Lublin, Poland, 20-582 Ai Centrum Medyczne Sp. Z O.O. Sp.K.Poznan, Poland, 61-113 Korczowski Bartosz Gabinet LekarskiRzeszow, Poland, 35-302 Endoskopia Sp. Z O. O.Sopot, Poland, 81-756 Szpital Sredzki Serca Jezusowego Sp. Z O.O.Sroda Wielkopolska, Poland, 63-000 Ez-Med Sp. Z O.O. Sp.K.Swidnica, Poland, 58-100 Pracownia Endoskopii Szpital MswSzczecin, Poland, 70-001 Twoja Przychodnia Szczecinskie Centrum MedyczneSzczecin, Poland, 71-434 Gastromed Kopon, Zmudzinski I Wspolnicy Sp.J.Torun, Poland, 87-100 Centrum Zdrowia MdmWarszawa, Poland, 00-635 Centrum Diagnostyczno-Lecznicze Barska Sp. Z O. O.Wloclawek, Poland, 87-800 Melita Medical Sp. Z O.O.Wroclaw, Poland, 50-449 Centrum Gastrologiczno HepatologiczneWroclaw, Poland, 50-555 LexmedicaWroclaw, Poland, 53-114 Russian Federation, Sestroretsk Spb Sbih \"City Hospital #40 Of The Kurortnyi Region\"Saint-Petersburg, Sestroretsk, Russian Federation, 197706 Russian Federation Llc \"Alliance Biomedical-Ural Group\"Izhevsk, Russian Federation, 426061 Clinic Of Fsbei He Ksmu Moh RfKrasnodar, Russian Federation, 350072 Llc \"Olla-Med\"Moscow, Russian Federation, 105554 Sechenov University On The Base Of Institute Of Translational Medicine And BiotechnologyMoscow, Russian Federation, 119435 Limited Liability Company \"Medical Center Sibnovomed\"Novosibirsk, Russian Federation, 630005 Federal State Budgetary Scientific Institution \"Scientific Research Institute Of Physiology AndNovosibirsk, Russian Federation, 630117 Clinic At Fsbei He \"Omsk State Medical University\" Moh RfOmsk, Russian Federation, 644050 Llc \"New Clinic\"Pyatigorsk, Russian Federation, 357500 Limited Liability Company \"Riat\"Saint-Petersburg, Russian Federation, 195220 Saint-Petersburg State Budgetary Healthcare Institution \"City Hospital #26\"Saint-Petersburg, Russian Federation, 196247 Private Institution Educational Organization Of Higher EducationSamara, Russian Federation, 443011 Non-State Healthcare Institution 'Railway Clinical Hospital At Samara Station Of Open Joint StockSamara, Russian Federation, 443029 Saint-Petersburg State Budgetary Healthcare Institution \"City Clinical Hospital Of The RighteousSt. Petersburg, Russian Federation, 197706|Tychy, Silesia, Poland, 43-100|Zemun, Beograd, Serbia, 11080|Beograd, Serbia, 11000 Klinicko Bolnicki Centar Zemun, Klinika Za Internu Medicinu,Zemun, Beograd, Serbia, 11080|Beograd, Srbija, Serbia, 11000 Klinicki Centar KragujevacKragujevac, Srbija, Serbia, 34000 Klinicki Centar NisNis, Srbija, Serbia, 18000 Opsta Bolnica SuboticaSubotica, Srbija, Serbia, 24000 Opsta Bolnica \"Djordje Joanovic\", Odeljenje Interno, Odsek GastroenterologijaZrenjanin, Srbija, Serbia, 23000|Banska Bystrica, Slovakia, 975 17 Breznianske Centrum Gastroenterologie S.R.O.Brezno, Slovakia, 97701 Km Management Spol. S.R.O.Nitra, Slovakia, 949 01 Accout Center S.R.O. Gastroenterologicka AmbulanciaSahy, Slovakia, 936 01 Endomed, S.R.O.Vranov Nad Toplou, Slovakia, 093 01|Lenasia, Gauteng, South Africa, 1827 Wits Clinical Research Trial SiteParktown, Gauteng, South Africa, 2193 Wits Clinical Reasearch - Wits Bara Clinical Trial SiteSoweto, Gauteng, South Africa, 2013|Claremont, Western Cape, South Africa, 7708|Santander, Cantabria, Spain, 39008|Granada, Spain, 18014 Hospital Universitario Ramon Y CajalMadrid, Spain, 28034 Hospital Universitario Virgen Del RocioSevilla, Spain, 41013 Hospital Universitari I Politecnic La FeValencia, Spain, 46026|Tunis, Tunisia, 1007 Habib Thameur HospitalTunis, Tunisia, 1008|Ankara, Turkey, 06100 Ankara Universitesi Tip Fakultesi, Ibn-I Sina HastanesiAnkara, Turkey, 06100 Hacettepe Universitesi Tip FakultesiAnkara, Turkey, 06230 Bezmialem Vakif Universitesi Tip Fakultesi HastanesiIstanbul, Turkey, 34093 Istanbul Universitesi Cerrahpasa Tip FacultesiIstanbul, Turkey, 34098 Istanbul Universitesi Cerrahpasa Tip FakultesiIstanbul, Turkey, 34098 Erciyes Universitesi Tip FakultesiKayseri, Turkey, 38039 Kocaeli Universitesi Tip FakultesiKocaeli, Turkey, 41380 Mersin Universitesi Tip Fakultesi Hastanesi, Ic HastaliklariMersin, Turkey, 33110 Mersin Universitesi Tip Fakultesi HastanesiMersin, Turkey, 33110 Karadeniz Teknik Universitesi Tip Fakultesi, Ic HastaliklariTrabzon, Turkey, 61080 Karadeniz Teknik Universitesi Tip FakultesiTrabzon, Turkey, 61080 Bulent Ecevit Universitesi Tip FakultesiZonguldak, Turkey, 67600|Chernivtsi, Ukraine, 58001 Regional Municipal Institution \"Chernivtsi Regional Clinical Hospital\", Surgery DepartmentChernivtsi, Ukraine, 58001 Traumatology And Orthopedic Center LlcChernivtsi, Ukraine, 58023 Municipal Healthcare Institution Kharkiv City Clinical Hospital #2 N.A. Prof. O.O. ShalimovKharkiv, Ukraine, 61037 Private Enterprise Of Private Manufacturing Company \"Acinus\", Medical And Diagnostic CenterKropyvnytskyi, Ukraine, 25006 Kyiv Municipal Clinical Hospital #18, Proctology DepartmentKyiv, Ukraine, 01030 Medical Center \"Universal Clinic Oberig\" Of \"Kapital\" Llc, Gastro CenterKyiv, Ukraine, 03680 Lviv Clinical Hospital On Railway Transport Of Health Care Center Branch Of Pjsc Ukrainian RailwayLviv, Ukraine, 79007 Vinnytsia City Clinical Hospital No.1Vinnytsia, Ukraine, 21000 Private Small-Scale Enterprise Medical Center \"Pulse\"Vinnytsia, Ukraine, 21001 Vinnytsia Regional Clinical Hospital For War VeteransVinnytsia, Ukraine, 21005 Vinnytsia Regional Clinical Hospital N.A. M.I.PyrohovVinnytsia, Ukraine, 21018|Dothan, Alabama, United States, 36301 Gut P.C., Dba Digestive Health Specialists Of The SoutheastDothan, Alabama, United States, 36305|Beverly Hills, California, United States, 90210 Long Beach Clinical Trial Services, Inc.Long Beach, California, United States, 90806 Entertainment Medical GroupLos Angeles, California, United States, 90036 Gastrointestinal Biosciences Clinical Trials, LlcLos Angeles, California, United States, 90067 Alliance Clinical Research, LlcPoway, California, United States, 92064|Clearwater, Florida, United States, 33756-3839 West Coast Endoscopy CenterClearwater, Florida, United States, 33756 Gastro FloridaClearwater, Florida, United States, 33762 University Of Miami Clinical Research BuildingMiami, Florida, United States, 33136 University Of Miami Crohn'S And Colitis CenterMiami, Florida, United States, 33136 University Of Miami Hospital And ClinicsMiami, Florida, United States, 33136 University Of Miami HospitalMiami, Florida, United States, 33136 Millenia Surgery CenterOrlando, Florida, United States, 32811 Hmd Research LlcOrlando, Florida, United States, 32819 Orlando Gastroenterology, PaOrlando, Florida, United States, 32835|Shawnee Mission, Kansas, United States, 66217|Houma, Louisiana, United States, 70360 Gulf Coast Surgical CenterHouma, Louisiana, United States, 70360 The Hearing Center (Audiology)Houma, Louisiana, United States, 70360|Chevy Chase, Maryland, United States, 20815 Mgg Group Co., Inc., Chevy Chase Clinical ResearchChevy Chase, Maryland, United States, 20815 Capitol ResearchRockville, Maryland, United States, 20850|Boston, Massachusetts, United States, 02115 Mass Eye And Ear, LongwoodBoston, Massachusetts, United States, 02115 Brigham And Women'S HospitalChestnut Hill, Massachusetts, United States, 02467 Umass Memorial Medical CenterWorcester, Massachusetts, United States, 01655 University Of Massachusetts Medical SchoolWorcester, Massachusetts, United States, 01655|Caro, Michigan, United States, 48723 Clinical Research Institute Of Michigan, LlcChesterfield, Michigan, United States, 48047 Eastside Endoscopy CenterMacomb, Michigan, United States, 48044 Eastside Endoscopy CenterSaint Clair Shores, Michigan, United States, 48081|New York, New York, United States, 10021 New York Presbyterian Hospital - Weill Cornell Medical College (Colonoscopy)New York, New York, United States, 10065 New York Presbyterian Hospital - Weill Cornell Medical College Investigational PharmacyNew York, New York, United States, 10065 Weill Cornell Medical College - New York Presbyterian Hospital (Endoscopy Suite)New York, New York, United States, 10065 Weill Cornell Medical College - New York Presbyterian HospitalNew York, New York, United States, 10065 Digiovanna Institute For Medical Education And ResearchNorth Massapequa, New York, United States, 11758-1853|Chapel Hill, North Carolina, United States, 27514 Unc Hospitals Endoscopy Center At MeadowmontChapel Hill, North Carolina, United States, 27517 University Of North Carolina At Chapel HillChapel Hill, North Carolina, United States, 27599 Gastroenterology Associates Of The Piedmont, PaWinston-Salem, North Carolina, United States, 27103 Pmg Research Of Winston-Salem, LlcWinston-Salem, North Carolina, United States, 27103|Kingsport, Tennessee, United States, 37660 Holston Valley Surgery CenterKingsport, Tennessee, United States, 37660 Vanderbilt University Medical CenterNashville, Tennessee, United States, 37212-1375 Vanderbilt University Medical CenterNashville, Tennessee, United States, 37212-1610 Vanderbilt University Medical Center - Gi Endoscopy LabNashville, Tennessee, United States, 37232-5543 Vanderbilt University Medical CenterNashville, Tennessee, United States, 37232-7610 Vanderbilt University Medical Center - Gi Research RegulatoryNashville, Tennessee, United States, 37232|Arlington, Texas, United States, 76012 Envision Imaging (Cxr)Arlington, Texas, United States, 76012 Texas Clinical Research Institiute, LlcArlington, Texas, United States, 76012 Hermann Drive Surgical HospitalHouston, Texas, United States, 77004 Pearland Surgery CenterHouston, Texas, United States, 77047 Gulf Coast Research Group, LlcHouston, Texas, United States, 77098 North Texas Research AssociatesMckinney, Texas, United States, 75069 Lonestar Endoscopy, LlpSouthlake, Texas, United States, 76092 Texas Digestive Disease ConsultantsSouthlake, Texas, United States, 76092|Fairfax, Virginia, United States, 22031","Alabama|California|Florida|Kansas|Louisiana|Maryland|Massachusetts|Michigan|New York|North Carolina|Tennessee|Texas|Virginia","Australia|Belgium|Bosnia And Herzegovina|Canada|Croatia|Czechia|France|Georgia|Germany|Hungary|Italy|Lebanon|Poland|Serbia|Slovakia|South Africa|Spain|Tunisia|Turkey|Ukraine|United States","New South Wales Concord Repatriation General Hospital|Queensland Mater Misericordiae Ltd|Saint John Of God Subiaco Hospital|Victoria Ballarat Base Hospital|University Hospital Brussels|Javna Zdravstvena Ustanova Univerzitetski Klinicki Centar Republike Srpske,|Manitoba Winnipeg Regional Health Authority - Health Sciences Centre, Winnipeg|Ontario HÃ´pital Montfort|Hrvatska Klinicki Bolnicki Centar Sestre Milosrdnice|Klinicki Bolnicki Centar Rijeka, Odjel Za Gastroenterologiju|Lekarna Altea|Hospital|The First University Clinic Of Tsmu|Paian Med Research Gmbh|Bekes Megyei Kozponti Korhaz, Rethy Pal Tagkorhaz|A.O.U. Policlinico G. Martino|Bari Istituto Di Ricovero E Cura A Carattere Scientifico (Ircss) S. De Bellis|Bs A.O.Spedali Civili|Cz Univ. \"Magna Graecia\" Di Catanzaro|Mb Asst Monza|Milano Asst Rhodense - Ospedale Di Circolo Di Rho|American University Of Beirut Medical Center|Niepubliczny Zaklad Opieki Zdrowotnej All-Medicus|Silesia H-T. Centrum Medyczne-Endoterapia|Beograd Klinicko Bolnicki Centar \"Bezanijska Kosa\"|Klinicko Bolnicki Centar Zvezdara, Klinika Za Interne Bolesti,|Srbija Klinicki Centar Srbije, Klinika Za Gastroenterohepatologiju|Fakultna Nemocnica S Poliklinikou F.D. Roosevelta Banska Bystrica|, Gauteng Lenasia Clinical Trial Centre|, Western Cape Dr Wright Private Practice|Cantabria Hospital Universitario Marques De Valdecilla|Hospital Universitario Virgen De Las Nieves De Granada|La Rabta Hospital|Ankara Universitesi Tip Fakultesi, Ibn-I Sina Hastanesi, Ic Hastaliklari Anabilim Dali,|Regional Municipal Institution \"Chernivtsi Regional Clinical Hospital\", Gastroenterology Department,|Dothan Surgery Center|Brighton Surgical Center|Gastro Florida|Westglen Gastrointestinal Consultants, P.A.|Cronola, Llc|Chevy Chase Endoscopy Center|Brigham And Women's Hospital|Caro Health Plaza|Weill Cornell Medical College (Clinical Site)|Unc Hospitals|Holston Medical Group|Cross Timbers Surgery Center L.P. (Colonoscopy)|Verity Research, Inc.",{"$nulls":3},"Pfizer CT.gov Call Center","2019-02-11","2020-05-25T16:36:03.727","2020-05-26T17:10:42.972","NCT03395184"]
["5ecbf3f411702c1b1b916a1c","NCT03395184","2019-03-20","Pfizer","PFE","Recruiting","Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PFâ€‘06700841 In Subjects With Moderate To Severe Crohn's Disease","Brepocitinib|Pf-06651600","JAK1 Inhibitor|TYK2 Inhibitor|JAK1 Inhibitor|JAK3 Inhibitor","Yes","['Brepocitinib', 'Pf-06651600']","Yes","['TYK2 Inhibitor', 'JAK3 Inhibitor']","Phase 2",2,250,"Anticipated","2018-02-02","2020-02-04","DAS","Disease Activity Score",{"$nulls":3},"The objectives of this study are to evaluate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-06651600 (200 mg for 8 weeks followed by 50 mg for 4 weeks) dosed once daily and PF-06700841 (60 mg for 12 weeks) dosed once daily during an induction period of 12 weeks, followed by an open label extension period at doses of 50 mg and 30 mg of PF 06651600 and PF 06700841, respectively, for 52 weeks.",null,"A PHASE 2A, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ORAL PF-06651600 AND PF-06700841 AS INDUCTION AND OPEN LABEL EXTENSION TREATMENT IN SUBJECTS WITH MODERATE TO SEVERE CROHN'S DISEASE","B7981007","Crohn's Disease","Crohn Disease","Gastrointestinal Diseases","Gastrointestinal","Experimental","PF-06700841 or placebo|PF-06651600 or placebo",null,"Drug","Placebo PF-06700841|PF-06700841|Placebo PF-06651600|PF-06651600","12 weeks, followed by PF-06700841, 30 mg QD for 52 weeks.|60 mg QD for 12 weeks followed by 30 mg QD for up to 52 weeks|12 weeks, followed by PF-06651600, 50 mg QD for 52 weeks|200 mg QD for 8 weeks, followed by 50 mg QD up to 56 weeks",null,"PF-06700841 or placebo|PF-06651600 or placebo","\n\n 1. Male and/or female subjects 18 years to 75 years of age\n 2. Documented diagnosis of ileal, ileocolonic, or colonic CD with a minimum disease duration of 3 months, as determined by endoscopic and histopathology assessment.\n 3. Endoscopic confirmation of active disease with total SES CD total score of at least 7. For isolated ileal disease, SES CD total score should be at least 4.\n 4. An average daily liquid/soft stool frequency (SF) greater than or equal to 2.5 or daily abdominal pain (AP) greater than or equal to 2.0.\n 5. Must have inadequate response to, loss of response to, or intolerance to at least one conventional therapy for CD:â€¢Steroids; Immunosuppressants (azathioprine [AZA], 6 MP, or methotrexate [MTX]); Anti TNF inhibitors (infliximab, adalimumab,certolizumab); Anti integrin inhibitors (eg, vedolizumab); Anti IL 12/23 inhibitor (ustekinumab).\n    \n    \n 6. Subjects currently receiving the following treatment for CD are eligible providing they have been on stable doses as described below: * Oral corticosteroids (prednisone or equivalent up to 25 mg/day; budesonide up to 9 mg/day). Stable dose for at least 2 weeks prior to baseline. If oral corticosteroids have been recently discontinued, they must have been stopped at least 2 weeks prior to baseline. Decreases in steroid use due to AEs are allowed.\n     * Oral 5 ASA or sulfasalazine are allowed providing that the dose is stable for at least 4 weeks prior to baseline.\n     * Crohn's disease related antibiotics are allowed providing that the dose is stable for at least 4 weeks prior to baseline. If antibiotics are stopped prior to baseline, they must be discontinued at least 4 days prior to baseline.\n    \n    \n\n","\n\n 1.  Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, diverticular disease, ulcerative colitis (UC), or clinical findings suggestive of UC.\n 2.  Presence of active (draining) fistulae or intra abdominal or perineal abscesses.\n 3.  Strictures with obstructive symptoms.\n 4.  Short bowel syndrome.\n 5.  History of bowel perforation requiring surgical intervention within the past 12 months.\n 6.  Previous bowel surgery resulting in an existing stoma. Subjects who have a j pouch are excluded, as a j pouch can result in a stoma.\n 7.  History of bowel surgery within 6 months prior to baseline.\n 8.  Subjects displaying clinical signs of fulminant colitis or toxic megacolon.\n 9.  Subjects with primary sclerosing cholangitis.\n 10. Subjects with evidence of colonic adenomas, dysplasia or neoplasia.\n 11. Abnormal findings on the chest x ray film such as presence of tuberculosis (TB), general infections, heart failure, or malignancy.\n 12. Any history of either untreated or inadequately treated latent or active TB infection, current treatment for active or latent TB infection or evidence of currently active TB by chest x ray, residing with or frequent close contact with individual(s) with active TB.\n 13. Subjects receiving the following therapies within the time period described below or expected to receive any of these therapies during the study period: 1.  >9 mg/day of oral budesonide or >25 mg/day of prednisone or equivalent oral systemic corticosteroid dose within 2 weeks prior to baseline.\n      2.  IV, IM (parenteral), or topical (rectal) treatment of 5 ASA or corticosteroid enemas/suppositories within 2 weeks prior to baseline.\n      3.  Azathioprine, 6 mercaptopurine, or methotrexate within 2 weeks prior to baseline.\n      4.  Anti TNF inhibitors (or biosimilars thereof) as described below: * Infliximab within 8 weeks prior to baseline;\n           * Adalimumab within 8 weeks prior to baseline;\n           * Certolizumab within 8 weeks prior to baseline;\n          \n          \n      5.  Anti integrin inhibitors (eg, vedolizumab) within 8 weeks prior to baseline.\n      6.  Ustekinumab within 8 weeks prior to baseline.\n      7.  Interferon therapy within 8 weeks prior to baseline.\n      8.  Subjects with prior treatment with lymphocyte depleting agents/therapies within 1 year prior to baseline (eg, CamPath[alemtuzumab], alkylating agents [eg, cyclophosphamide or chlorambucil], total lymphoid irradiation, etc).\n      9.  Subjects who have received rituximab or other selective B lymphocyte depleting agents within 1 year prior to baseline.\n      10. Subjects previously receiving leukocyte apheresis, including selective lymphocyte, monocyte, or granulocyte apheresis, or plasma exchange within 6 months prior to baseline.\n      11. Other marketed immunosuppressants or biologics with immunomodulatory properties within 3 months prior to baseline.\n      12. Subjects who have received other JAK inhibitors within 3 months prior to baseline.\n      13. Subjects who have not responded to or have been intolerant of other JAK inhibitors.\n      14. Other investigational procedures(s) or product(s), such as immunosuppressants used in transplantation (eg, mycophenolate mofetil, cyclosporine, rapamycin, or tacrolimus) or live (attenuated) vaccine within 30 days prior to baseline.","TNF","tumor necrosis factor","Protein","Lung, Breast, Ovary","Actual","2018-01-10","Actual","Anticipated","2021-02-18","Anticipated","2019-03-01","2017-12-05","2018-01-03","2019-03-18","Yes",null,"Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years","75 Years","All",null,"No","Yes\nPfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",null,"URL: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7981007&StudyName=A+Phase+2a%2C+Double-blind%2C+Randomized%2C+Placebo-controlled%2C+Parallel+Group+Study+To+Evaluate+The+Efficacy+And+Safety+Of+Oral+Pf-06651600+And+Pf-06700841+As+Induction+And+Open+Label+Extension+Treatment+In+Subjects+With+Moderate+To+Severe+Crohn%E2%80%99s+Disease [https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7981007&StudyName=A+Phase+2a%2C+Double-blind%2C+Randomized%2C+Placebo-controlled%2C+Parallel+Group+Study+To+Evaluate+The+Efficacy+And+Safety+Of+Oral+Pf-06651600+And+Pf-06700841+As+Induction+And+Open+Label+Extension+Treatment+In+Subjects+With+Moderate+To+Severe+Crohn%E2%80%99s+Disease] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To obtain contact information for a study center near you, click here.",null,"Yes","No",{"$nulls":17},"2017-003359-43|PIZZICATO","EudraCT Number|Alias Study Number","Proportion of subjects achieving clinically meaningful endoscopic improvement (reduction of more than or equal to 3 points from baseline in Simplified Endoscopic Activity Score for Crohn's Disease (SES-CD) at Week 12","12 weeks",null,"Number of participants with potentially clinically important serious infections findings|Mean change from baseline in SES-CD score at Week 12.|Proportion of subjects achieving SES-CD 25 and SES-CD 50 at Week 12.|Proportion of subjects achieving endoscopic remission (SES-CD less than or equal to 2) at Week 12.|Proportion of subjects achieving mucosal healing at Week 12.|Number of subjects with adverse events|Number of subjects with serious adverse events|Number of subjects with electrocardiogram findings of potential clinical importance.|Number of subjects withdrawal due to adverse events|Number of subjects with vital signs findings of potential clinical importance.|Number of subjects with laboratory tests findings of potential clinical importance.|Proportion of subjects achieving SES CD 25 and SES CD 50 at Week 64 among subjects who achieved SES CD 25 and SES CD 50 at week 12 respectively.|Proportion of subjects achieving clinically meaningful endoscopic improvement (CMEI response) at week 64 among subjects who achieved CMEI response at Week 12.","64 weeks|Baseline, week 12|Number of subjects achieving SES-CD 25 and SES-CD 50 at Week 12.|Number of subjects achieving endoscopic remission (SES-CD less than or equal to 2) at Week 12.|Number of subjects achieving mucosal healing at Week 12.|Number of participants with reported adverse events|Number of participants with reported serious adverse events|Number of participants with potentially clinically important electrocardiogram findings.|Number of subjects withdrawal due to adverse events.|Number of participants with potentially clinically important vital signs findings.|Number of participants with potentially clinically important laboratory findings.|Number of subjects achieving SES-CD 25 and SES-CD 50 at Week 64 among subjects who achieved SES CD 25 and SES CD 50 at week 12|Number of subject achieving clinically meaningful endoscopic improvement (CMEI response) at week 64 among subjects who achieved CMEI response at week 12.","Baseline, week 12|Week 12|Baseline up to 64 weeks|Baseline u to 64 weeks|week 64","ClinicalTrials.gov_Inquiries@pfizer.com","Pfizer CT.gov Call Center","1-800-718-1021","Concord, New South Wales, Australia, 2139|South Brisbane, Queensland, Australia, 4101|Subiaco, Western|Ballarat, Victoria, Australia, 3350|Jette, Belgium, 1090 University Hospitals LeuvenLeuven, Belgium, 3000 Chc - Saint-JosephLiÃ¨ge, Belgium, 4000|Banja Luka, Bosnia And Herzegovina, 78000 Sveucilisna Klinicka Bolnica Mostar,Mostar, Bosnia And Herzegovina, 88000|Winnipeg, Manitoba, Canada, R3A 1R9|Ottawa, Ontario, Canada, K1K 0T2|Zagreb, Hrvatska, Croatia, 10000|Rijeka, Croatia, 51000 Klinicki Bolnicki Centar Split, Zavod Za GastroenterologijuSplit, Croatia, 21000 Opca Bolnica Zadar, Odjel Za GastroenterologijuZadar, Croatia, 23000 Klinicka Bolnica Dubrava ZagrebZagreb, Croatia, 10000 Klinicki Bolnicki Centar Zagreb, Zavod Za Gastroenterologiju I HepatologijuZagreb, Croatia, 10000|Bilina, Czechia, 41801 Nemocnice Horovice, A.S.Horovice, Czechia, 268 31 Hepato-Gastroenterologie Hk S.R.O.Hradec Kralove, Czechia, 500 12 Medialpharma S.R.O.Hradec Kralove, Czechia, 500 12 Gastroenterologicka Ambulance A EndoskopieMost, Czechia, 43401 Artroscan, S.R.O., Gastroenterologicke OddeleniOstrava, Czechia, 722 00 Lekarna U VitkaOstrava, Czechia, 722 00 Vseobecna Fakultni NemocnicePraha 2, Czechia, 128 08 VÅ¡eobecnÃ¡ FakultnÃ­ Nemocnice V PrazePraha 2, Czechia, 128 08 Nemocnice Strakonice, A.S., Interni OddeleniStrakonice, Czechia, 386 01 Nemocnice Strakonice, A.S.Strakonice, Czechia, 386 29|Achrafieh, Beirut, Lebanon|Tbilisi, Georgia, 0141 David Tatishvili Medical CenterTbilisi, Georgia, 0186|Berlin, Germany, 10318 Krankenhaus Waldfriede E.V.,Berlin, Germany, 14163 Universitaetsklinikum BonnBonn, Germany, 53127|Bekescsaba, Hungary, 5600 Semmelweis Egyetem, Ii. Belgyogyaszati KlinikaBudapest, Hungary, 1088 Szent Janos Korhaz Es Eszak-Budai Egyesitett KorhazakBudapest, Hungary, 1125 Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz, Endoszkopos LaboratoriumGyula, Hungary, 5700 Clinfan Szolgaltato Kft.Szekszard, Hungary, 7100 Csolnoky Ferenc Korhaz Belgyogyaszati Centrum I. Belgyogyaszati OsztalyVeszprem, Hungary, 8200|Messina, Italy, 98125 Istituto Clinico Humanitas Irccs - Ibd CenterMilan, Italy, 20089 Aou Policlinico Di ModenaModena, Italy, 41124 Azienda Ospedaliera Di PadovaPadova, Italy, 35128 Policlinico Universitario Campus Bio-MedicoRoma, Italy, 00128 Policlinico Gemelli/Complesso Integrato ColumbusRome, Italy, 00168 Korea, Republic Of, Korea Kyungpook National University HospitalDaegu, Korea, Korea, Republic Of, 41944 Korea, Republic Of Kyung Hee University HospitalSeoul, Korea, Republic Of, 02447 Kangbuk Samsung HospitalSeoul, Korea, Republic Of, 03181 Severance Hospital, Yonsei University Health SystemSeoul, Korea, Republic Of, 03722 The Catholic University Of Korea, Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591|Castellana Grotte, Bari, Italy, 70013|Brescia, Bs, Italy, 25123|Catanzaro, Cz, Italy, 88100|Monza, Mb, Italy, 20090|Rho, Milano, Italy, 20017|Beirut, Lebanon Ain Wazein Medical VillageEl Chouf, Lebanon Centre Hospitalier Universitaire Notre Dame De SecoursJbeil, Lebanon Hammoud Hospital University Medical CenterSaida, Lebanon|Katowice, Poland, 40-659 Etg KielceKielce, Poland, 25-355 Indywidualna Specjalstyczna Praktyka Lekarska Maciej ZymlaKnurow, Poland, 44-190 Szpital W Knurowie Sp. Z O.O.Knurow, Poland, 44-190 Centrum Badan Klinicznych JciKrakow, Poland, 30-348 Marta Dagmara Banach Marta Banach Specjalistyczny Gabinet NeurologicznyKrakow, Poland, 30-539 Centrum Medyczne EvitaKrakow, Poland, 31-153 Szpital Specjalistyczny Im. Ludwika Rydygiera W Krakowie Sp. Z O.O.Krakow, Poland, 31-826 Centrum Medyczne Szpital Swietej Rodziny Sp Z O.O.Lodz, Poland, 90-302 Pracownia Endoskopii Centrum Medyczne Szpital Swietej Rodziny Sp Z O.O.Lodz, Poland, 90-302 Medical Magnus ClinicLodz, Poland, 90-552 Wojewodzki Szpital Specjalistyczny Im. Bieganskiego W LodziLodz, Poland, 91-347 Gastromed Sp. Z O.O.Lublin, Poland, 20-582 Ai Centrum Medyczne Sp. Z O.O. Sp.K.Poznan, Poland, 61-113 Korczowski Bartosz Gabinet LekarskiRzeszow, Poland, 35-302 Endoskopia Sp. Z O. O.Sopot, Poland, 81-756 Szpital Sredzki Serca Jezusowego Sp. Z O.O.Sroda Wielkopolska, Poland, 63-000 Ez-Med Sp. Z O.O. Sp.K.Swidnica, Poland, 58-100 Pracownia Endoskopii Szpital MswSzczecin, Poland, 70-001 Twoja Przychodnia Szczecinskie Centrum MedyczneSzczecin, Poland, 71-434 Gastromed Kopon, Zmudzinski I Wspolnicy Sp.J.Torun, Poland, 87-100 Centrum Zdrowia MdmWarszawa, Poland, 00-635 Centrum Diagnostyczno-Lecznicze Barska Sp. Z O. O.Wloclawek, Poland, 87-800 Melita Medical Sp. Z O.O.Wroclaw, Poland, 50-449 Centrum Gastrologiczno HepatologiczneWroclaw, Poland, 50-555 LexmedicaWroclaw, Poland, 53-114 Russian Federation, Sestroretsk Spb Sbih \"City Hospital #40 Of The Kurortnyi Region\"Saint-Petersburg, Sestroretsk, Russian Federation, 197706 Russian Federation Llc \"Alliance Biomedical-Ural Group\"Izhevsk, Russian Federation, 426061 Clinic Of Fsbei He Ksmu Moh RfKrasnodar, Russian Federation, 350072 Llc \"Olla-Med\"Moscow, Russian Federation, 105554 Sechenov University On The Base Of Institute Of Translational Medicine And BiotechnologyMoscow, Russian Federation, 119435 Limited Liability Company \"Medical Center Sibnovomed\"Novosibirsk, Russian Federation, 630005 Federal State Budgetary Scientific Institution \"Scientific Research Institute Of Physiology AndNovosibirsk, Russian Federation, 630117 Clinic At Fsbei He \"Omsk State Medical University\" Moh RfOmsk, Russian Federation, 644050 Llc \"New Clinic\"Pyatigorsk, Russian Federation, 357500 Limited Liability Company \"Riat\"Saint-Petersburg, Russian Federation, 195220 Saint-Petersburg State Budgetary Healthcare Institution \"City Hospital #26\"Saint-Petersburg, Russian Federation, 196247 Private Institution Educational Organization Of Higher EducationSamara, Russian Federation, 443011 Non-State Healthcare Institution 'Railway Clinical Hospital At Samara Station Of Open Joint StockSamara, Russian Federation, 443029 Saint-Petersburg State Budgetary Healthcare Institution \"City Clinical Hospital Of The RighteousSt. Petersburg, Russian Federation, 197706|Tychy, Silesia, Poland, 43-100|Zemun, Beograd, Serbia, 11080|Beograd, Serbia, 11000 Klinicko Bolnicki Centar Zemun, Klinika Za Internu Medicinu,Zemun, Beograd, Serbia, 11080|Beograd, Srbija, Serbia, 11000 Klinicki Centar KragujevacKragujevac, Srbija, Serbia, 34000 Klinicki Centar NisNis, Srbija, Serbia, 18000 Opsta Bolnica SuboticaSubotica, Srbija, Serbia, 24000 Opsta Bolnica \"Djordje Joanovic\", Odeljenje Interno, Odsek GastroenterologijaZrenjanin, Srbija, Serbia, 23000|Banska Bystrica, Slovakia, 975 17 Breznianske Centrum Gastroenterologie S.R.O.Brezno, Slovakia, 97701 Km Management Spol. S.R.O.Nitra, Slovakia, 949 01 Accout Center S.R.O. Gastroenterologicka AmbulanciaSahy, Slovakia, 936 01 Endomed, S.R.O.Vranov Nad Toplou, Slovakia, 093 01|Lenasia, Gauteng, South Africa, 1827 Wits Clinical Research Trial SiteParktown, Gauteng, South Africa, 2193 Wits Clinical Reasearch - Wits Bara Clinical Trial SiteSoweto, Gauteng, South Africa, 2013|Claremont, Western Cape, South Africa, 7708|Santander, Cantabria, Spain, 39008|Granada, Spain, 18014 Hospital Universitario Ramon Y CajalMadrid, Spain, 28034 Hospital Universitario Virgen Del RocioSevilla, Spain, 41013 Hospital Universitari I Politecnic La FeValencia, Spain, 46026|Tunis, Tunisia, 1007 Habib Thameur HospitalTunis, Tunisia, 1008|Ankara, Turkey, 06100 Ankara Universitesi Tip Fakultesi, Ibn-I Sina HastanesiAnkara, Turkey, 06100 Hacettepe Universitesi Tip FakultesiAnkara, Turkey, 06230 Bezmialem Vakif Universitesi Tip Fakultesi HastanesiIstanbul, Turkey, 34093 Istanbul Universitesi Cerrahpasa Tip FacultesiIstanbul, Turkey, 34098 Istanbul Universitesi Cerrahpasa Tip FakultesiIstanbul, Turkey, 34098 Erciyes Universitesi Tip FakultesiKayseri, Turkey, 38039 Kocaeli Universitesi Tip FakultesiKocaeli, Turkey, 41380 Mersin Universitesi Tip Fakultesi Hastanesi, Ic HastaliklariMersin, Turkey, 33110 Mersin Universitesi Tip Fakultesi HastanesiMersin, Turkey, 33110 Karadeniz Teknik Universitesi Tip Fakultesi, Ic HastaliklariTrabzon, Turkey, 61080 Karadeniz Teknik Universitesi Tip FakultesiTrabzon, Turkey, 61080 Bulent Ecevit Universitesi Tip FakultesiZonguldak, Turkey, 67600|Chernivtsi, Ukraine, 58001 Regional Municipal Institution \"Chernivtsi Regional Clinical Hospital\", Surgery DepartmentChernivtsi, Ukraine, 58001 Traumatology And Orthopedic Center LlcChernivtsi, Ukraine, 58023 Municipal Healthcare Institution Kharkiv City Clinical Hospital #2 N.A. Prof. O.O. ShalimovKharkiv, Ukraine, 61037 Private Enterprise Of Private Manufacturing Company \"Acinus\", Medical And Diagnostic CenterKropyvnytskyi, Ukraine, 25006 Kyiv Municipal Clinical Hospital #18, Proctology DepartmentKyiv, Ukraine, 01030 Medical Center \"Universal Clinic Oberig\" Of \"Kapital\" Llc, Gastro CenterKyiv, Ukraine, 03680 Lviv Clinical Hospital On Railway Transport Of Health Care Center Branch Of Pjsc Ukrainian RailwayLviv, Ukraine, 79007 Vinnytsia City Clinical Hospital No.1Vinnytsia, Ukraine, 21000 Private Small-Scale Enterprise Medical Center \"Pulse\"Vinnytsia, Ukraine, 21001 Vinnytsia Regional Clinical Hospital For War VeteransVinnytsia, Ukraine, 21005 Vinnytsia Regional Clinical Hospital N.A. M.I.PyrohovVinnytsia, Ukraine, 21018|Dubai, United Arab Emirates, 22241|Dothan, Alabama, United States, 36301 Gut P.C., Dba Digestive Health Specialists Of The SoutheastDothan, Alabama, United States, 36305|Beverly Hills, California, United States, 90210 Long Beach Clinical Trial Services, Inc.Long Beach, California, United States, 90806 Entertainment Medical GroupLos Angeles, California, United States, 90036 Gastrointestinal Biosciences Clinical Trials, LlcLos Angeles, California, United States, 90067 Alliance Clinical Research, LlcPoway, California, United States, 92064|Clearwater, Florida, United States, 33756-3839 West Coast Endoscopy CenterClearwater, Florida, United States, 33756 Gastro FloridaClearwater, Florida, United States, 33762 University Of Miami Clinical Research BuildingMiami, Florida, United States, 33136 University Of Miami Crohn'S And Colitis CenterMiami, Florida, United States, 33136 University Of Miami Hospital And ClinicsMiami, Florida, United States, 33136 University Of Miami HospitalMiami, Florida, United States, 33136 Millenia Surgery CenterOrlando, Florida, United States, 32811 Hmd Research LlcOrlando, Florida, United States, 32819 Orlando Gastroenterology, PaOrlando, Florida, United States, 32835|Shawnee Mission, Kansas, United States, 66217|Houma, Louisiana, United States, 70360 Gulf Coast Surgical CenterHouma, Louisiana, United States, 70360 The Hearing Center (Audiology)Houma, Louisiana, United States, 70360|Chevy Chase, Maryland, United States, 20815 Mgg Group Co., Inc., Chevy Chase Clinical ResearchChevy Chase, Maryland, United States, 20815 Capitol ResearchRockville, Maryland, United States, 20850|Boston, Massachusetts, United States, 02115 Mass Eye And Ear, LongwoodBoston, Massachusetts, United States, 02115 Brigham And Women'S HospitalChestnut Hill, Massachusetts, United States, 02467 Umass Memorial Medical CenterWorcester, Massachusetts, United States, 01655 University Of Massachusetts Medical SchoolWorcester, Massachusetts, United States, 01655|Caro, Michigan, United States, 48723 Clinical Research Institute Of Michigan, LlcChesterfield, Michigan, United States, 48047 Eastside Endoscopy CenterMacomb, Michigan, United States, 48044 Eastside Endoscopy CenterSaint Clair Shores, Michigan, United States, 48081|New York, New York, United States, 10021 New York Presbyterian Hospital - Weill Cornell Medical College (Colonoscopy)New York, New York, United States, 10065 New York Presbyterian Hospital - Weill Cornell Medical College Investigational PharmacyNew York, New York, United States, 10065 Weill Cornell Medical College - New York Presbyterian Hospital (Endoscopy Suite)New York, New York, United States, 10065 Weill Cornell Medical College - New York Presbyterian HospitalNew York, New York, United States, 10065 Digiovanna Institute For Medical Education And ResearchNorth Massapequa, New York, United States, 11758-1853|Chapel Hill, North Carolina, United States, 27514 Unc Hospitals Endoscopy Center At MeadowmontChapel Hill, North Carolina, United States, 27517 University Of North Carolina At Chapel HillChapel Hill, North Carolina, United States, 27599 Gastroenterology Associates Of The Piedmont, PaWinston-Salem, North Carolina, United States, 27103 Pmg Research Of Winston-Salem, LlcWinston-Salem, North Carolina, United States, 27103|Kingsport, Tennessee, United States, 37660 Holston Valley Surgery CenterKingsport, Tennessee, United States, 37660 Vanderbilt University Medical CenterNashville, Tennessee, United States, 37212-1375 Vanderbilt University Medical CenterNashville, Tennessee, United States, 37212-1610 Vanderbilt University Medical Center - Gi Endoscopy LabNashville, Tennessee, United States, 37232-5543 Vanderbilt University Medical CenterNashville, Tennessee, United States, 37232-7610 Vanderbilt University Medical Center - Gi Research RegulatoryNashville, Tennessee, United States, 37232|Arlington, Texas, United States, 76012 Envision Imaging (Cxr)Arlington, Texas, United States, 76012 Texas Clinical Research Institiute, LlcArlington, Texas, United States, 76012 Hermann Drive Surgical HospitalHouston, Texas, United States, 77004 Pearland Surgery CenterHouston, Texas, United States, 77047 Gulf Coast Research Group, LlcHouston, Texas, United States, 77098 North Texas Research AssociatesMckinney, Texas, United States, 75069 Lonestar Endoscopy, LlpSouthlake, Texas, United States, 76092 Texas Digestive Disease ConsultantsSouthlake, Texas, United States, 76092|Fairfax, Virginia, United States, 22031","Alabama|California|Florida|Kansas|Louisiana|Maryland|Massachusetts|Michigan|New York|North Carolina|Tennessee|Texas|Virginia","Australia|Belgium|Bosnia And Herzegovina|Canada|Croatia|Czechia|France|Georgia|Germany|Hungary|Italy|Lebanon|Poland|Serbia|Slovakia|South Africa|Spain|Tunisia|Turkey|Ukraine|United Arab Emirates|United States","New South Wales Concord Repatriation General Hospital|Queensland Mater Misericordiae Ltd|Saint John Of God Subiaco Hospital|Victoria Ballarat Base Hospital|University Hospital Brussels|Javna Zdravstvena Ustanova Univerzitetski Klinicki Centar Republike Srpske,|Manitoba Winnipeg Regional Health Authority - Health Sciences Centre, Winnipeg|Ontario HÃ´pital Montfort|Hrvatska Klinicki Bolnicki Centar Sestre Milosrdnice|Klinicki Bolnicki Centar Rijeka, Odjel Za Gastroenterologiju|Lekarna Altea|Hospital|The First University Clinic Of Tsmu|Paian Med Research Gmbh|Bekes Megyei Kozponti Korhaz, Rethy Pal Tagkorhaz|A.O.U. Policlinico G. Martino|Bari Istituto Di Ricovero E Cura A Carattere Scientifico (Ircss) S. De Bellis|Bs A.O.Spedali Civili|Cz Univ. \"Magna Graecia\" Di Catanzaro|Mb Asst Monza|Milano Asst Rhodense - Ospedale Di Circolo Di Rho|American University Of Beirut Medical Center|Niepubliczny Zaklad Opieki Zdrowotnej All-Medicus|Silesia H-T. Centrum Medyczne-Endoterapia|Beograd Klinicko Bolnicki Centar \"Bezanijska Kosa\"|Klinicko Bolnicki Centar Zvezdara, Klinika Za Interne Bolesti,|Srbija Klinicki Centar Srbije, Klinika Za Gastroenterohepatologiju|Fakultna Nemocnica S Poliklinikou F.D. Roosevelta Banska Bystrica|, Gauteng Lenasia Clinical Trial Centre|, Western Cape Dr Wright Private Practice|Cantabria Hospital Universitario Marques De Valdecilla|Hospital Universitario Virgen De Las Nieves De Granada|La Rabta Hospital|Ankara Universitesi Tip Fakultesi, Ibn-I Sina Hastanesi, Ic Hastaliklari Anabilim Dali,|Regional Municipal Institution \"Chernivtsi Regional Clinical Hospital\", Gastroenterology Department,|Al Baraha Hospital - Moh|Dothan Surgery Center|Brighton Surgical Center|Gastro Florida|Westglen Gastrointestinal Consultants, P.A.|Cronola, Llc|Chevy Chase Endoscopy Center|Brigham And Women's Hospital|Caro Health Plaza|Weill Cornell Medical College (Clinical Site)|Unc Hospitals|Holston Medical Group|Cross Timbers Surgery Center L.P. (Colonoscopy)|Verity Research, Inc.",{"$nulls":3},"Pfizer CT.gov Call Center","2019-03-18","2020-05-25T16:36:04.341","2020-05-26T17:10:42.972","NCT03395184"]
["5ecbf3f5fe30261b1a04820b","NCT03395184","2019-04-16","Pfizer","PFE","Recruiting","Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PFâ€‘06700841 In Subjects With Moderate To Severe Crohn's Disease","Brepocitinib|Pf-06651600","JAK1 Inhibitor|TYK2 Inhibitor|JAK1 Inhibitor|JAK3 Inhibitor","Yes","['Brepocitinib', 'Pf-06651600']","Yes","['TYK2 Inhibitor', 'JAK3 Inhibitor']","Phase 2",2,250,"Anticipated","2018-02-02","2020-02-04","DAS","Disease Activity Score",{"$nulls":3},"The objectives of this study are to evaluate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-06651600 (200 mg for 8 weeks followed by 50 mg for 4 weeks) dosed once daily and PF-06700841 (60 mg for 12 weeks) dosed once daily during an induction period of 12 weeks, followed by an open label extension period at doses of 50 mg and 30 mg of PF 06651600 and PF 06700841, respectively, for 52 weeks.",null,"A PHASE 2A, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ORAL PF-06651600 AND PF-06700841 AS INDUCTION AND OPEN LABEL EXTENSION TREATMENT IN SUBJECTS WITH MODERATE TO SEVERE CROHN'S DISEASE","B7981007","Crohn's Disease","Crohn Disease","Gastrointestinal Diseases","Gastrointestinal","Experimental","PF-06700841 or placebo|PF-06651600 or placebo",null,"Drug","Placebo PF-06700841|PF-06700841|Placebo PF-06651600|PF-06651600","12 weeks, followed by PF-06700841, 30 mg QD for 52 weeks.|60 mg QD for 12 weeks followed by 30 mg QD for up to 52 weeks|12 weeks, followed by PF-06651600, 50 mg QD for 52 weeks|200 mg QD for 8 weeks, followed by 50 mg QD up to 56 weeks",null,"PF-06700841 or placebo|PF-06651600 or placebo","\n\n 1. Male and/or female subjects 18 years to 75 years of age\n 2. Documented diagnosis of ileal, ileocolonic, or colonic CD with a minimum disease duration of 3 months, as determined by endoscopic and histopathology assessment.\n 3. Endoscopic confirmation of active disease with total SES CD total score of at least 7. For isolated ileal disease, SES CD total score should be at least 4.\n 4. An average daily liquid/soft stool frequency (SF) greater than or equal to 2.5 or daily abdominal pain (AP) greater than or equal to 2.0.\n 5. Must have inadequate response to, loss of response to, or intolerance to at least one conventional therapy for CD:â€¢Steroids; Immunosuppressants (azathioprine [AZA], 6 MP, or methotrexate [MTX]); Anti TNF inhibitors (infliximab, adalimumab,certolizumab); Anti integrin inhibitors (eg, vedolizumab); Anti IL 12/23 inhibitor (ustekinumab).\n    \n    \n 6. Subjects currently receiving the following treatment for CD are eligible providing they have been on stable doses as described below: * Oral corticosteroids (prednisone or equivalent up to 25 mg/day; budesonide up to 9 mg/day). Stable dose for at least 2 weeks prior to baseline. If oral corticosteroids have been recently discontinued, they must have been stopped at least 2 weeks prior to baseline. Decreases in steroid use due to AEs are allowed.\n     * Oral 5 ASA or sulfasalazine are allowed providing that the dose is stable for at least 4 weeks prior to baseline.\n     * Crohn's disease related antibiotics are allowed providing that the dose is stable for at least 4 weeks prior to baseline. If antibiotics are stopped prior to baseline, they must be discontinued at least 4 days prior to baseline.\n    \n    \n\n","\n\n 1.  Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, diverticular disease, ulcerative colitis (UC), or clinical findings suggestive of UC.\n 2.  Presence of active (draining) fistulae or intra abdominal or perineal abscesses.\n 3.  Strictures with obstructive symptoms.\n 4.  Short bowel syndrome.\n 5.  History of bowel perforation requiring surgical intervention within the past 12 months.\n 6.  Previous bowel surgery resulting in an existing stoma. Subjects who have a j pouch are excluded, as a j pouch can result in a stoma.\n 7.  History of bowel surgery within 6 months prior to baseline.\n 8.  Subjects displaying clinical signs of fulminant colitis or toxic megacolon.\n 9.  Subjects with primary sclerosing cholangitis.\n 10. Subjects with evidence of colonic adenomas, dysplasia or neoplasia.\n 11. Abnormal findings on the chest x ray film such as presence of tuberculosis (TB), general infections, heart failure, or malignancy.\n 12. Any history of either untreated or inadequately treated latent or active TB infection, current treatment for active or latent TB infection or evidence of currently active TB by chest x ray, residing with or frequent close contact with individual(s) with active TB.\n 13. Subjects receiving the following therapies within the time period described below or expected to receive any of these therapies during the study period: 1.  >9 mg/day of oral budesonide or >25 mg/day of prednisone or equivalent oral systemic corticosteroid dose within 2 weeks prior to baseline.\n      2.  IV, IM (parenteral), or topical (rectal) treatment of 5 ASA or corticosteroid enemas/suppositories within 2 weeks prior to baseline.\n      3.  Azathioprine, 6 mercaptopurine, or methotrexate within 2 weeks prior to baseline.\n      4.  Anti TNF inhibitors (or biosimilars thereof) as described below: * Infliximab within 8 weeks prior to baseline;\n           * Adalimumab within 8 weeks prior to baseline;\n           * Certolizumab within 8 weeks prior to baseline;\n          \n          \n      5.  Anti integrin inhibitors (eg, vedolizumab) within 8 weeks prior to baseline.\n      6.  Ustekinumab within 8 weeks prior to baseline.\n      7.  Interferon therapy within 8 weeks prior to baseline.\n      8.  Subjects with prior treatment with lymphocyte depleting agents/therapies within 1 year prior to baseline (eg, CamPath[alemtuzumab], alkylating agents [eg, cyclophosphamide or chlorambucil], total lymphoid irradiation, etc).\n      9.  Subjects who have received rituximab or other selective B lymphocyte depleting agents within 1 year prior to baseline.\n      10. Subjects previously receiving leukocyte apheresis, including selective lymphocyte, monocyte, or granulocyte apheresis, or plasma exchange within 6 months prior to baseline.\n      11. Other marketed immunosuppressants or biologics with immunomodulatory properties within 3 months prior to baseline.\n      12. Subjects who have received other JAK inhibitors within 3 months prior to baseline.\n      13. Subjects who have not responded to or have been intolerant of other JAK inhibitors.\n      14. Other investigational procedures(s) or product(s), such as immunosuppressants used in transplantation (eg, mycophenolate mofetil, cyclosporine, rapamycin, or tacrolimus) or live (attenuated) vaccine within 30 days prior to baseline.","TNF","tumor necrosis factor","Protein","Lung, Breast, Ovary","Actual","2018-01-10","Actual","Anticipated","2021-02-18","Anticipated","2019-04-01","2017-12-05","2018-01-03","2019-04-15","Yes",null,"Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years","75 Years","All",null,"No","Yes\nPfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",null,"URL: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7981007&StudyName=A+Phase+2a%2C+Double-blind%2C+Randomized%2C+Placebo-controlled%2C+Parallel+Group+Study+To+Evaluate+The+Efficacy+And+Safety+Of+Oral+Pf-06651600+And+Pf-06700841+As+Induction+And+Open+Label+Extension+Treatment+In+Subjects+With+Moderate+To+Severe+Crohn%E2%80%99s+Disease [https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7981007&StudyName=A+Phase+2a%2C+Double-blind%2C+Randomized%2C+Placebo-controlled%2C+Parallel+Group+Study+To+Evaluate+The+Efficacy+And+Safety+Of+Oral+Pf-06651600+And+Pf-06700841+As+Induction+And+Open+Label+Extension+Treatment+In+Subjects+With+Moderate+To+Severe+Crohn%E2%80%99s+Disease] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To obtain contact information for a study center near you, click here.",null,"Yes","No",{"$nulls":17},"2017-003359-43|PIZZICATO","EudraCT Number|Alias Study Number","Proportion of subjects achieving clinically meaningful endoscopic improvement (reduction of more than or equal to 3 points from baseline in Simplified Endoscopic Activity Score for Crohn's Disease (SES-CD) at Week 12","12 weeks",null,"Number of participants with potentially clinically important serious infections findings|Mean change from baseline in SES-CD score at Week 12.|Proportion of subjects achieving SES-CD 25 and SES-CD 50 at Week 12.|Proportion of subjects achieving endoscopic remission (SES-CD less than or equal to 2) at Week 12.|Proportion of subjects achieving mucosal healing at Week 12.|Number of subjects with adverse events|Number of subjects with serious adverse events|Number of subjects with electrocardiogram findings of potential clinical importance.|Number of subjects withdrawal due to adverse events|Number of subjects with vital signs findings of potential clinical importance.|Number of subjects with laboratory tests findings of potential clinical importance.|Proportion of subjects achieving SES CD 25 and SES CD 50 at Week 64 among subjects who achieved SES CD 25 and SES CD 50 at week 12 respectively.|Proportion of subjects achieving clinically meaningful endoscopic improvement (CMEI response) at week 64 among subjects who achieved CMEI response at Week 12.","64 weeks|Baseline, week 12|Number of subjects achieving SES-CD 25 and SES-CD 50 at Week 12.|Number of subjects achieving endoscopic remission (SES-CD less than or equal to 2) at Week 12.|Number of subjects achieving mucosal healing at Week 12.|Number of participants with reported adverse events|Number of participants with reported serious adverse events|Number of participants with potentially clinically important electrocardiogram findings.|Number of subjects withdrawal due to adverse events.|Number of participants with potentially clinically important vital signs findings.|Number of participants with potentially clinically important laboratory findings.|Number of subjects achieving SES-CD 25 and SES-CD 50 at Week 64 among subjects who achieved SES CD 25 and SES CD 50 at week 12|Number of subject achieving clinically meaningful endoscopic improvement (CMEI response) at week 64 among subjects who achieved CMEI response at week 12.","Baseline, week 12|Week 12|Baseline up to 64 weeks|Baseline u to 64 weeks|week 64","ClinicalTrials.gov_Inquiries@pfizer.com","Pfizer CT.gov Call Center","1-800-718-1021","Concord, New South Wales, Australia, 2139|South Brisbane, Queensland, Australia, 4101|Subiaco, Western|Ballarat, Victoria, Australia, 3350|Jette, Belgium, 1090 University Hospitals LeuvenLeuven, Belgium, 3000 Chc - Saint-JosephLiÃ¨ge, Belgium, 4000|Banja Luka, Bosnia And Herzegovina, 78000 Sveucilisna Klinicka Bolnica Mostar,Mostar, Bosnia And Herzegovina, 88000|Winnipeg, Manitoba, Canada, R3A 1R9|Ottawa, Ontario, Canada, K1K 0T2|Zagreb, Hrvatska, Croatia, 10000|Rijeka, Croatia, 51000 Klinicki Bolnicki Centar Split, Zavod Za GastroenterologijuSplit, Croatia, 21000 Opca Bolnica Zadar, Odjel Za GastroenterologijuZadar, Croatia, 23000 Klinicka Bolnica Dubrava ZagrebZagreb, Croatia, 10000 Klinicki Bolnicki Centar Zagreb, Zavod Za Gastroenterologiju I HepatologijuZagreb, Croatia, 10000|Bilina, Czechia, 41801 Nemocnice Horovice, A.S.Horovice, Czechia, 268 31 Hepato-Gastroenterologie Hk S.R.O.Hradec Kralove, Czechia, 500 12 Medialpharma S.R.O.Hradec Kralove, Czechia, 500 12 Gastroenterologicka Ambulance A EndoskopieMost, Czechia, 43401 Artroscan, S.R.O., Gastroenterologicke OddeleniOstrava, Czechia, 722 00 Lekarna U VitkaOstrava, Czechia, 722 00 Vseobecna Fakultni NemocnicePraha 2, Czechia, 128 08 VÅ¡eobecnÃ¡ FakultnÃ­ Nemocnice V PrazePraha 2, Czechia, 128 08 Nemocnice Strakonice, A.S., Interni OddeleniStrakonice, Czechia, 386 01 Nemocnice Strakonice, A.S.Strakonice, Czechia, 386 29|Achrafieh, Beirut, Lebanon|Tbilisi, Georgia, 0141 David Tatishvili Medical CenterTbilisi, Georgia, 0186|Berlin, Germany, 10318 Krankenhaus Waldfriede E.V.,Berlin, Germany, 14163 Universitaetsklinikum BonnBonn, Germany, 53127|Bekescsaba, Hungary, 5600 Semmelweis Egyetem, Ii. Belgyogyaszati KlinikaBudapest, Hungary, 1088 Szent Janos Korhaz Es Eszak-Budai Egyesitett KorhazakBudapest, Hungary, 1125 Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz, Endoszkopos LaboratoriumGyula, Hungary, 5700 Clinfan Szolgaltato Kft.Szekszard, Hungary, 7100 Csolnoky Ferenc Korhaz Belgyogyaszati Centrum I. Belgyogyaszati OsztalyVeszprem, Hungary, 8200|Messina, Italy, 98125 Istituto Clinico Humanitas Irccs - Ibd CenterMilan, Italy, 20089 Aou Policlinico Di ModenaModena, Italy, 41124 Azienda Ospedaliera Di PadovaPadova, Italy, 35128 Policlinico Universitario Campus Bio-MedicoRoma, Italy, 00128 Policlinico Gemelli/Complesso Integrato ColumbusRome, Italy, 00168 Korea, Republic Of, Korea Kyungpook National University HospitalDaegu, Korea, Korea, Republic Of, 41944 Korea, Republic Of Kyung Hee University HospitalSeoul, Korea, Republic Of, 02447 Kangbuk Samsung HospitalSeoul, Korea, Republic Of, 03181 Severance Hospital, Yonsei University Health SystemSeoul, Korea, Republic Of, 03722 The Catholic University Of Korea, Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591|Castellana Grotte, Bari, Italy, 70013|Brescia, Bs, Italy, 25123|Catanzaro, Cz, Italy, 88100|Monza, Mb, Italy, 20090|Rho, Milano, Italy, 20017|Beirut, Lebanon Ain Wazein Medical VillageEl Chouf, Lebanon Centre Hospitalier Universitaire Notre Dame De SecoursJbeil, Lebanon Hammoud Hospital University Medical CenterSaida, Lebanon|Katowice, Poland, 40-659 Etg KielceKielce, Poland, 25-355 Indywidualna Specjalstyczna Praktyka Lekarska Maciej ZymlaKnurow, Poland, 44-190 Szpital W Knurowie Sp. Z O.O.Knurow, Poland, 44-190 Centrum Badan Klinicznych JciKrakow, Poland, 30-348 Marta Dagmara Banach Marta Banach Specjalistyczny Gabinet NeurologicznyKrakow, Poland, 30-539 Centrum Medyczne EvitaKrakow, Poland, 31-153 Szpital Specjalistyczny Im. Ludwika Rydygiera W Krakowie Sp. Z O.O.Krakow, Poland, 31-826 Centrum Medyczne Szpital Swietej Rodziny Sp Z O.O.Lodz, Poland, 90-302 Pracownia Endoskopii Centrum Medyczne Szpital Swietej Rodziny Sp Z O.O.Lodz, Poland, 90-302 Medical Magnus ClinicLodz, Poland, 90-552 Wojewodzki Szpital Specjalistyczny Im. Bieganskiego W LodziLodz, Poland, 91-347 Gastromed Sp. Z O.O.Lublin, Poland, 20-582 Ai Centrum Medyczne Sp. Z O.O. Sp.K.Poznan, Poland, 61-113 Korczowski Bartosz Gabinet LekarskiRzeszow, Poland, 35-302 Endoskopia Sp. Z O. O.Sopot, Poland, 81-756 Szpital Sredzki Serca Jezusowego Sp. Z O.O.Sroda Wielkopolska, Poland, 63-000 Ez-Med Sp. Z O.O. Sp.K.Swidnica, Poland, 58-100 Pracownia Endoskopii Szpital MswSzczecin, Poland, 70-001 Twoja Przychodnia Szczecinskie Centrum MedyczneSzczecin, Poland, 71-434 Gastromed Kopon, Zmudzinski I Wspolnicy Sp.J.Torun, Poland, 87-100 Centrum Zdrowia MdmWarszawa, Poland, 00-635 Centrum Diagnostyczno-Lecznicze Barska Sp. Z O. O.Wloclawek, Poland, 87-800 Melita Medical Sp. Z O.O.Wroclaw, Poland, 50-449 Centrum Gastrologiczno HepatologiczneWroclaw, Poland, 50-555 LexmedicaWroclaw, Poland, 53-114 Russian Federation, Sestroretsk Spb Sbih \"City Hospital #40 Of The Kurortnyi Region\"Saint-Petersburg, Sestroretsk, Russian Federation, 197706 Russian Federation Llc \"Alliance Biomedical-Ural Group\"Izhevsk, Russian Federation, 426061 Clinic Of Fsbei He Ksmu Moh RfKrasnodar, Russian Federation, 350072 Llc \"Olla-Med\"Moscow, Russian Federation, 105554 Sechenov University On The Base Of Institute Of Translational Medicine And BiotechnologyMoscow, Russian Federation, 119435 Limited Liability Company \"Medical Center Sibnovomed\"Novosibirsk, Russian Federation, 630005 Federal State Budgetary Scientific Institution \"Scientific Research Institute Of Physiology AndNovosibirsk, Russian Federation, 630117 Clinic At Fsbei He \"Omsk State Medical University\" Moh RfOmsk, Russian Federation, 644050 Llc \"New Clinic\"Pyatigorsk, Russian Federation, 357500 Limited Liability Company \"Riat\"Saint-Petersburg, Russian Federation, 195220 Saint-Petersburg State Budgetary Healthcare Institution \"City Hospital #26\"Saint-Petersburg, Russian Federation, 196247 Private Institution Educational Organization Of Higher EducationSamara, Russian Federation, 443011 Non-State Healthcare Institution 'Railway Clinical Hospital At Samara Station Of Open Joint StockSamara, Russian Federation, 443029 Saint-Petersburg State Budgetary Healthcare Institution \"City Clinical Hospital Of The RighteousSt. Petersburg, Russian Federation, 197706|Tychy, Silesia, Poland, 43-100|Zemun, Beograd, Serbia, 11080|Beograd, Serbia, 11000 Klinicko Bolnicki Centar Zemun, Klinika Za Internu Medicinu,Zemun, Beograd, Serbia, 11080|Beograd, Srbija, Serbia, 11000 Klinicki Centar KragujevacKragujevac, Srbija, Serbia, 34000 Klinicki Centar NisNis, Srbija, Serbia, 18000 Opsta Bolnica SuboticaSubotica, Srbija, Serbia, 24000 Opsta Bolnica \"Djordje Joanovic\", Odeljenje Interno, Odsek GastroenterologijaZrenjanin, Srbija, Serbia, 23000|Banska Bystrica, Slovakia, 975 17 Breznianske Centrum Gastroenterologie S.R.O.Brezno, Slovakia, 97701 Km Management Spol. S.R.O.Nitra, Slovakia, 949 01 Accout Center S.R.O. Gastroenterologicka AmbulanciaSahy, Slovakia, 936 01 Endomed, S.R.O.Vranov Nad Toplou, Slovakia, 093 01|Lenasia, Gauteng, South Africa, 1827 Wits Clinical Research Trial SiteParktown, Gauteng, South Africa, 2193 Wits Clinical Reasearch - Wits Bara Clinical Trial SiteSoweto, Gauteng, South Africa, 2013|Claremont, Western Cape, South Africa, 7708|Santander, Cantabria, Spain, 39008|Madrid, Spain, 28034 Hospital Universitario Virgen Del RocioSevilla, Spain, 41013 Hospital Universitari I Politecnic La FeValencia, Spain, 46026|Tunis, Tunisia, 1007 Habib Thameur HospitalTunis, Tunisia, 1008|Ankara, Turkey, 06100 Ankara Universitesi Tip Fakultesi, Ibn-I Sina HastanesiAnkara, Turkey, 06100 Hacettepe Universitesi Tip FakultesiAnkara, Turkey, 06230 Bezmialem Vakif Universitesi Tip Fakultesi HastanesiIstanbul, Turkey, 34093 Istanbul Universitesi Cerrahpasa Tip FacultesiIstanbul, Turkey, 34098 Istanbul Universitesi Cerrahpasa Tip FakultesiIstanbul, Turkey, 34098 Erciyes Universitesi Tip FakultesiKayseri, Turkey, 38039 Kocaeli Universitesi Tip FakultesiKocaeli, Turkey, 41380 Mersin Universitesi Tip Fakultesi Hastanesi, Ic HastaliklariMersin, Turkey, 33110 Mersin Universitesi Tip Fakultesi HastanesiMersin, Turkey, 33110 Karadeniz Teknik Universitesi Tip Fakultesi, Ic HastaliklariTrabzon, Turkey, 61080 Karadeniz Teknik Universitesi Tip FakultesiTrabzon, Turkey, 61080 Bulent Ecevit Universitesi Tip FakultesiZonguldak, Turkey, 67600|Chernivtsi, Ukraine, 58001 Regional Municipal Institution \"Chernivtsi Regional Clinical Hospital\", Surgery DepartmentChernivtsi, Ukraine, 58001 Traumatology And Orthopedic Center LlcChernivtsi, Ukraine, 58023 Municipal Healthcare Institution Kharkiv City Clinical Hospital #2 N.A. Prof. O.O. ShalimovKharkiv, Ukraine, 61037 Private Enterprise Of Private Manufacturing Company \"Acinus\", Medical And Diagnostic CenterKropyvnytskyi, Ukraine, 25006 Kyiv Municipal Clinical Hospital #18, Proctology DepartmentKyiv, Ukraine, 01030 Medical Center \"Universal Clinic Oberig\" Of \"Kapital\" Llc, Gastro CenterKyiv, Ukraine, 03680 Lviv Clinical Hospital On Railway Transport Of Health Care Center Branch Of Pjsc Ukrainian RailwayLviv, Ukraine, 79007 Vinnytsia City Clinical Hospital No.1Vinnytsia, Ukraine, 21000 Private Small-Scale Enterprise Medical Center \"Pulse\"Vinnytsia, Ukraine, 21001 Vinnytsia Regional Clinical Hospital For War VeteransVinnytsia, Ukraine, 21005 Vinnytsia Regional Clinical Hospital N.A. M.I.PyrohovVinnytsia, Ukraine, 21018|Dubai, United Arab Emirates, 22241|Dothan, Alabama, United States, 36301 Gut P.C., Dba Digestive Health Specialists Of The SoutheastDothan, Alabama, United States, 36305|Beverly Hills, California, United States, 90210 Long Beach Clinical Trial Services, Inc.Long Beach, California, United States, 90806 Entertainment Medical GroupLos Angeles, California, United States, 90036 Gastrointestinal Biosciences Clinical Trials, LlcLos Angeles, California, United States, 90067 Alliance Clinical Research, LlcPoway, California, United States, 92064|Clearwater, Florida, United States, 33756-3839 West Coast Endoscopy CenterClearwater, Florida, United States, 33756 Gastro FloridaClearwater, Florida, United States, 33762 University Of Miami Clinical Research BuildingMiami, Florida, United States, 33136 University Of Miami Crohn'S And Colitis CenterMiami, Florida, United States, 33136 University Of Miami Hospital And ClinicsMiami, Florida, United States, 33136 University Of Miami HospitalMiami, Florida, United States, 33136 Millenia Surgery CenterOrlando, Florida, United States, 32811 Hmd Research LlcOrlando, Florida, United States, 32819|Shawnee Mission, Kansas, United States, 66217|Houma, Louisiana, United States, 70360 Gulf Coast Surgical CenterHouma, Louisiana, United States, 70360 The Hearing Center (Audiology)Houma, Louisiana, United States, 70360|Chevy Chase, Maryland, United States, 20815 Mgg Group Co., Inc., Chevy Chase Clinical ResearchChevy Chase, Maryland, United States, 20815 Capitol ResearchRockville, Maryland, United States, 20850|Boston, Massachusetts, United States, 02115 Mass Eye And Ear, LongwoodBoston, Massachusetts, United States, 02115 Brigham And Women'S HospitalChestnut Hill, Massachusetts, United States, 02467 Umass Memorial Medical CenterWorcester, Massachusetts, United States, 01655 University Of Massachusetts Medical SchoolWorcester, Massachusetts, United States, 01655|Caro, Michigan, United States, 48723 Clinical Research Institute Of Michigan, LlcChesterfield, Michigan, United States, 48047 Eastside Endoscopy CenterMacomb, Michigan, United States, 48044 Eastside Endoscopy CenterSaint Clair Shores, Michigan, United States, 48081|New York, New York, United States, 10021 New York Presbyterian Hospital - Weill Cornell Medical College (Colonoscopy)New York, New York, United States, 10065 New York Presbyterian Hospital - Weill Cornell Medical College Investigational PharmacyNew York, New York, United States, 10065 Weill Cornell Medical College - New York Presbyterian Hospital (Endoscopy Suite)New York, New York, United States, 10065 Weill Cornell Medical College - New York Presbyterian HospitalNew York, New York, United States, 10065 Digiovanna Institute For Medical Education And ResearchNorth Massapequa, New York, United States, 11758-1853|Chapel Hill, North Carolina, United States, 27514 Unc Hospitals Endoscopy Center At MeadowmontChapel Hill, North Carolina, United States, 27517 University Of North Carolina At Chapel HillChapel Hill, North Carolina, United States, 27599 Gastroenterology Associates Of The Piedmont, PaWinston-Salem, North Carolina, United States, 27103 Pmg Research Of Winston-Salem, LlcWinston-Salem, North Carolina, United States, 27103|Kingsport, Tennessee, United States, 37660 Holston Valley Surgery CenterKingsport, Tennessee, United States, 37660 Vanderbilt University Medical CenterNashville, Tennessee, United States, 37212-1375 Vanderbilt University Medical CenterNashville, Tennessee, United States, 37212-1610 Vanderbilt University Medical Center - Gi Endoscopy LabNashville, Tennessee, United States, 37232-5543 Vanderbilt University Medical CenterNashville, Tennessee, United States, 37232-7610 Vanderbilt University Medical Center - Gi Research RegulatoryNashville, Tennessee, United States, 37232|Arlington, Texas, United States, 76012 Envision Imaging (Cxr)Arlington, Texas, United States, 76012 Texas Clinical Research Institiute, LlcArlington, Texas, United States, 76012 Hermann Drive Surgical HospitalHouston, Texas, United States, 77004 Pearland Surgery CenterHouston, Texas, United States, 77047 Gulf Coast Research Group, LlcHouston, Texas, United States, 77098 Lonestar Endoscopy, LlpSouthlake, Texas, United States, 76092 Texas Digestive Disease ConsultantsSouthlake, Texas, United States, 76092|Fairfax, Virginia, United States, 22031","Alabama|California|Florida|Kansas|Louisiana|Maryland|Massachusetts|Michigan|New York|North Carolina|Tennessee|Texas|Virginia","Australia|Belgium|Bosnia And Herzegovina|Canada|Croatia|Czechia|France|Georgia|Germany|Hungary|Italy|Lebanon|Poland|Serbia|Slovakia|South Africa|Spain|Tunisia|Turkey|Ukraine|United Arab Emirates|United States","New South Wales Concord Repatriation General Hospital|Queensland Mater Misericordiae Ltd|Saint John Of God Subiaco Hospital|Victoria Ballarat Base Hospital|University Hospital Brussels|Javna Zdravstvena Ustanova Univerzitetski Klinicki Centar Republike Srpske,|Manitoba Winnipeg Regional Health Authority - Health Sciences Centre, Winnipeg|Ontario HÃ´pital Montfort|Hrvatska Klinicki Bolnicki Centar Sestre Milosrdnice|Klinicki Bolnicki Centar Rijeka, Odjel Za Gastroenterologiju|Lekarna Altea|Hospital|The First University Clinic Of Tsmu|Paian Med Research Gmbh|Bekes Megyei Kozponti Korhaz, Rethy Pal Tagkorhaz|A.O.U. Policlinico G. Martino|Bari Istituto Di Ricovero E Cura A Carattere Scientifico (Ircss) S. De Bellis|Bs A.O.Spedali Civili|Cz Univ. \"Magna Graecia\" Di Catanzaro|Mb Asst Monza|Milano Asst Rhodense - Ospedale Di Circolo Di Rho|American University Of Beirut Medical Center|Niepubliczny Zaklad Opieki Zdrowotnej All-Medicus|Silesia H-T. Centrum Medyczne-Endoterapia|Beograd Klinicko Bolnicki Centar \"Bezanijska Kosa\"|Klinicko Bolnicki Centar Zvezdara, Klinika Za Interne Bolesti,|Srbija Klinicki Centar Srbije, Klinika Za Gastroenterohepatologiju|Fakultna Nemocnica S Poliklinikou F.D. Roosevelta Banska Bystrica|, Gauteng Lenasia Clinical Trial Centre|, Western Cape Dr Wright Private Practice|Cantabria Hospital Universitario Marques De Valdecilla|Hospital Universitario Ramon Y Cajal|La Rabta Hospital|Ankara Universitesi Tip Fakultesi, Ibn-I Sina Hastanesi, Ic Hastaliklari Anabilim Dali,|Regional Municipal Institution \"Chernivtsi Regional Clinical Hospital\", Gastroenterology Department,|Al Baraha Hospital - Moh|Dothan Surgery Center|Brighton Surgical Center|Gastro Florida|Westglen Gastrointestinal Consultants, P.A.|Cronola, Llc|Chevy Chase Endoscopy Center|Brigham And Women's Hospital|Caro Health Plaza|Weill Cornell Medical College (Clinical Site)|Unc Hospitals|Holston Medical Group|Cross Timbers Surgery Center L.P. (Colonoscopy)|Verity Research, Inc.",{"$nulls":3},"Pfizer CT.gov Call Center","2019-04-15","2020-05-25T16:36:05.587","2020-05-26T17:10:42.972","NCT03395184"]
["5ecbf3f5fe30261b1a04820c","NCT03395184","2019-05-24","Pfizer","PFE","Recruiting","Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PFâ€‘06700841 In Subjects With Moderate To Severe Crohn's Disease","Brepocitinib|Pf-06651600","JAK1 Inhibitor|TYK2 Inhibitor|JAK1 Inhibitor|JAK3 Inhibitor","Yes","['Brepocitinib', 'Pf-06651600']","Yes","['TYK2 Inhibitor', 'JAK3 Inhibitor']","Phase 2",2,250,"Anticipated","2018-02-02","2020-02-04","DAS","Disease Activity Score",{"$nulls":3},"The objectives of this study are to evaluate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-06651600 (200 mg for 8 weeks followed by 50 mg for 4 weeks) dosed once daily and PF-06700841 (60 mg for 12 weeks) dosed once daily during an induction period of 12 weeks, followed by an open label extension period at doses of 50 mg and 30 mg of PF 06651600 and PF 06700841, respectively, for 52 weeks.",null,"A PHASE 2A, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ORAL PF-06651600 AND PF-06700841 AS INDUCTION AND OPEN LABEL EXTENSION TREATMENT IN SUBJECTS WITH MODERATE TO SEVERE CROHN'S DISEASE","B7981007","Crohn's Disease","Crohn Disease","Gastrointestinal Diseases","Gastrointestinal","Experimental","PF-06700841 or placebo|PF-06651600 or placebo",null,"Drug","Placebo PF-06700841|PF-06700841|Placebo PF-06651600|PF-06651600","12 weeks, followed by PF-06700841, 30 mg QD for 52 weeks.|60 mg QD for 12 weeks followed by 30 mg QD for up to 52 weeks|12 weeks, followed by PF-06651600, 50 mg QD for 52 weeks|200 mg QD for 8 weeks, followed by 50 mg QD up to 56 weeks",null,"PF-06700841 or placebo|PF-06651600 or placebo","\n\n 1. Male and/or female subjects 18 years to 75 years of age\n 2. Documented diagnosis of ileal, ileocolonic, or colonic CD with a minimum disease duration of 3 months, as determined by endoscopic and histopathology assessment.\n 3. Endoscopic confirmation of active disease with total SES CD total score of at least 7. For isolated ileal disease, SES CD total score should be at least 4.\n 4. An average daily liquid/soft stool frequency (SF) greater than or equal to 2.5 or daily abdominal pain (AP) greater than or equal to 2.0.\n 5. Must have inadequate response to, loss of response to, or intolerance to at least one conventional therapy for CD:â€¢Steroids; Immunosuppressants (azathioprine [AZA], 6 MP, or methotrexate [MTX]); Anti TNF inhibitors (infliximab, adalimumab,certolizumab); Anti integrin inhibitors (eg, vedolizumab); Anti IL 12/23 inhibitor (ustekinumab).\n    \n    \n 6. Subjects currently receiving the following treatment for CD are eligible providing they have been on stable doses as described below: * Oral corticosteroids (prednisone or equivalent up to 25 mg/day; budesonide up to 9 mg/day). Stable dose for at least 2 weeks prior to baseline. If oral corticosteroids have been recently discontinued, they must have been stopped at least 2 weeks prior to baseline. Decreases in steroid use due to AEs are allowed.\n     * Oral 5 ASA or sulfasalazine are allowed providing that the dose is stable for at least 4 weeks prior to baseline.\n     * Crohn's disease related antibiotics are allowed providing that the dose is stable for at least 4 weeks prior to baseline. If antibiotics are stopped prior to baseline, they must be discontinued at least 4 days prior to baseline.\n    \n    \n\n","\n\n 1.  Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, diverticular disease, ulcerative colitis (UC), or clinical findings suggestive of UC.\n 2.  Presence of active (draining) fistulae or intra abdominal or perineal abscesses.\n 3.  Strictures with obstructive symptoms.\n 4.  Short bowel syndrome.\n 5.  History of bowel perforation requiring surgical intervention within the past 12 months.\n 6.  Previous bowel surgery resulting in an existing stoma. Subjects who have a j pouch are excluded, as a j pouch can result in a stoma.\n 7.  History of bowel surgery within 6 months prior to baseline.\n 8.  Subjects displaying clinical signs of fulminant colitis or toxic megacolon.\n 9.  Subjects with primary sclerosing cholangitis.\n 10. Subjects with evidence of colonic adenomas, dysplasia or neoplasia.\n 11. Abnormal findings on the chest x ray film such as presence of tuberculosis (TB), general infections, heart failure, or malignancy.\n 12. Any history of either untreated or inadequately treated latent or active TB infection, current treatment for active or latent TB infection or evidence of currently active TB by chest x ray, residing with or frequent close contact with individual(s) with active TB.\n 13. Subjects receiving the following therapies within the time period described below or expected to receive any of these therapies during the study period: 1.  >9 mg/day of oral budesonide or >25 mg/day of prednisone or equivalent oral systemic corticosteroid dose within 2 weeks prior to baseline.\n      2.  IV, IM (parenteral), or topical (rectal) treatment of 5 ASA or corticosteroid enemas/suppositories within 2 weeks prior to baseline.\n      3.  Azathioprine, 6 mercaptopurine, or methotrexate within 2 weeks prior to baseline.\n      4.  Anti TNF inhibitors (or biosimilars thereof) as described below: * Infliximab within 8 weeks prior to baseline;\n           * Adalimumab within 8 weeks prior to baseline;\n           * Certolizumab within 8 weeks prior to baseline;\n          \n          \n      5.  Anti integrin inhibitors (eg, vedolizumab) within 8 weeks prior to baseline.\n      6.  Ustekinumab within 8 weeks prior to baseline.\n      7.  Interferon therapy within 8 weeks prior to baseline.\n      8.  Subjects with prior treatment with lymphocyte depleting agents/therapies within 1 year prior to baseline (eg, CamPath[alemtuzumab], alkylating agents [eg, cyclophosphamide or chlorambucil], total lymphoid irradiation, etc).\n      9.  Subjects who have received rituximab or other selective B lymphocyte depleting agents within 1 year prior to baseline.\n      10. Subjects previously receiving leukocyte apheresis, including selective lymphocyte, monocyte, or granulocyte apheresis, or plasma exchange within 6 months prior to baseline.\n      11. Other marketed immunosuppressants or biologics with immunomodulatory properties within 3 months prior to baseline.\n      12. Subjects who have received other JAK inhibitors within 3 months prior to baseline.\n      13. Subjects who have not responded to or have been intolerant of other JAK inhibitors.\n      14. Other investigational procedures(s) or product(s), such as immunosuppressants used in transplantation (eg, mycophenolate mofetil, cyclosporine, rapamycin, or tacrolimus) or live (attenuated) vaccine within 30 days prior to baseline.","TNF","tumor necrosis factor","Protein","Lung, Breast, Ovary","Actual","2018-01-10","Actual","Anticipated","2021-02-18","Anticipated","2019-05-01","2017-12-05","2018-01-03","2019-05-23","Yes",null,"Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years","75 Years","All",null,"No","Yes\nPfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",null,"URL: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7981007&StudyName=A+Phase+2a%2C+Double-blind%2C+Randomized%2C+Placebo-controlled%2C+Parallel+Group+Study+To+Evaluate+The+Efficacy+And+Safety+Of+Oral+Pf-06651600+And+Pf-06700841+As+Induction+And+Open+Label+Extension+Treatment+In+Subjects+With+Moderate+To+Severe+Crohn%E2%80%99s+Disease [https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7981007&StudyName=A+Phase+2a%2C+Double-blind%2C+Randomized%2C+Placebo-controlled%2C+Parallel+Group+Study+To+Evaluate+The+Efficacy+And+Safety+Of+Oral+Pf-06651600+And+Pf-06700841+As+Induction+And+Open+Label+Extension+Treatment+In+Subjects+With+Moderate+To+Severe+Crohn%E2%80%99s+Disease] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To obtain contact information for a study center near you, click here.",null,"Yes","No",{"$nulls":17},"2017-003359-43|PIZZICATO","EudraCT Number|Alias Study Number","Proportion of subjects achieving clinically meaningful endoscopic improvement (reduction of more than or equal to 3 points from baseline in Simplified Endoscopic Activity Score for Crohn's Disease (SES-CD) at Week 12","12 weeks",null,"Number of participants with potentially clinically important serious infections findings|Mean change from baseline in SES-CD score at Week 12.|Proportion of subjects achieving SES-CD 25 and SES-CD 50 at Week 12.|Proportion of subjects achieving endoscopic remission (SES-CD less than or equal to 2) at Week 12.|Proportion of subjects achieving mucosal healing at Week 12.|Number of subjects with adverse events|Number of subjects with serious adverse events|Number of subjects with electrocardiogram findings of potential clinical importance.|Number of subjects withdrawal due to adverse events|Number of subjects with vital signs findings of potential clinical importance.|Number of subjects with laboratory tests findings of potential clinical importance.|Proportion of subjects achieving SES CD 25 and SES CD 50 at Week 64 among subjects who achieved SES CD 25 and SES CD 50 at week 12 respectively.|Proportion of subjects achieving clinically meaningful endoscopic improvement (CMEI response) at week 64 among subjects who achieved CMEI response at Week 12.","64 weeks|Baseline, week 12|Number of subjects achieving SES-CD 25 and SES-CD 50 at Week 12.|Number of subjects achieving endoscopic remission (SES-CD less than or equal to 2) at Week 12.|Number of subjects achieving mucosal healing at Week 12.|Number of participants with reported adverse events|Number of participants with reported serious adverse events|Number of participants with potentially clinically important electrocardiogram findings.|Number of subjects withdrawal due to adverse events.|Number of participants with potentially clinically important vital signs findings.|Number of participants with potentially clinically important laboratory findings.|Number of subjects achieving SES-CD 25 and SES-CD 50 at Week 64 among subjects who achieved SES CD 25 and SES CD 50 at week 12|Number of subject achieving clinically meaningful endoscopic improvement (CMEI response) at week 64 among subjects who achieved CMEI response at week 12.","Baseline, week 12|Week 12|Baseline up to 64 weeks|Baseline u to 64 weeks|week 64","ClinicalTrials.gov_Inquiries@pfizer.com","Pfizer CT.gov Call Center","1-800-718-1021","Concord, New South Wales, Australia, 2139|South Brisbane, Queensland, Australia, 4101|Subiaco, Western|Ballarat, Victoria, Australia, 3350|Jette, Belgium, 1090 University Hospitals LeuvenLeuven, Belgium, 3000 Chc - Saint-JosephLiÃ¨ge, Belgium, 4000|Banja Luka, Bosnia And Herzegovina, 78000 Sveucilisna Klinicka Bolnica Mostar,Mostar, Bosnia And Herzegovina, 88000|Winnipeg, Manitoba, Canada, R3A 1R9|Ottawa, Ontario, Canada, K1K 0T2|Zagreb, Hrvatska, Croatia, 10000|Rijeka, Croatia, 51000 Klinicki Bolnicki Centar Split, Zavod Za GastroenterologijuSplit, Croatia, 21000 Opca Bolnica Zadar, Odjel Za GastroenterologijuZadar, Croatia, 23000 Klinicka Bolnica Dubrava ZagrebZagreb, Croatia, 10000 Klinicki Bolnicki Centar Zagreb, Zavod Za Gastroenterologiju I HepatologijuZagreb, Croatia, 10000|Bilina, Czechia, 41801 Nemocnice Horovice, A.S.Horovice, Czechia, 268 31 Hepato-Gastroenterologie Hk S.R.O.Hradec Kralove, Czechia, 500 12 Medialpharma S.R.O.Hradec Kralove, Czechia, 500 12 Gastroenterologicka Ambulance A EndoskopieMost, Czechia, 43401 Artroscan, S.R.O., Gastroenterologicke OddeleniOstrava, Czechia, 722 00 Lekarna U VitkaOstrava, Czechia, 722 00 Vseobecna Fakultni NemocnicePraha 2, Czechia, 128 08 VÅ¡eobecnÃ¡ FakultnÃ­ Nemocnice V PrazePraha 2, Czechia, 128 08 Nemocnice Strakonice, A.S., Interni OddeleniStrakonice, Czechia, 386 01 Nemocnice Strakonice, A.S.Strakonice, Czechia, 386 29|Achrafieh, Beirut, Lebanon|Tbilisi, Georgia, 0141 David Tatishvili Medical CenterTbilisi, Georgia, 0186|Berlin, Germany, 10318 Krankenhaus Waldfriede E.V.,Berlin, Germany, 14163 Universitaetsklinikum BonnBonn, Germany, 53127 Universitaetsklinikum Schleswig-HolsteinKiel, Germany, 24105|Bekescsaba, Hungary, 5600 Semmelweis Egyetem, Ii. Belgyogyaszati KlinikaBudapest, Hungary, 1088 Szent Janos Korhaz Es Eszak-Budai Egyesitett KorhazakBudapest, Hungary, 1125 Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz, Endoszkopos LaboratoriumGyula, Hungary, 5700 Clinfan Szolgaltato Kft.Szekszard, Hungary, 7100 Csolnoky Ferenc Korhaz Belgyogyaszati Centrum I. Belgyogyaszati OsztalyVeszprem, Hungary, 8200|Messina, Italy, 98125 Istituto Clinico Humanitas Irccs - Ibd CenterMilan, Italy, 20089 Aou Policlinico Di ModenaModena, Italy, 41124 Azienda Ospedaliera Di PadovaPadova, Italy, 35128 Policlinico Universitario Campus Bio-MedicoRoma, Italy, 00128 Policlinico Gemelli/Complesso Integrato ColumbusRome, Italy, 00168 Korea, Republic Of, Korea Kyungpook National University HospitalDaegu, Korea, Korea, Republic Of, 41944 Korea, Republic Of Kyung Hee University HospitalSeoul, Korea, Republic Of, 02447 Kangbuk Samsung HospitalSeoul, Korea, Republic Of, 03181 Severance Hospital, Yonsei University Health SystemSeoul, Korea, Republic Of, 03722 The Catholic University Of Korea, Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591|Castellana Grotte, Bari, Italy, 70013|Brescia, Bs, Italy, 25123|Catanzaro, Cz, Italy, 88100|Monza, Mb, Italy, 20090|Rho, Milano, Italy, 20017|Achrafieh, Lebanon American University Of Beirut Medical CenterBeirut, Lebanon Ain Wazein Medical VillageEl Chouf, Lebanon Centre Hospitalier Universitaire Notre Dame De SecoursJbeil, Lebanon Hammoud Hospital University Medical CenterSaida, Lebanon|Katowice, Poland, 40-659 Etg KielceKielce, Poland, 25-355 Indywidualna Specjalistyczna Praktyka Lekarska Maciej ZymlaKnurow, Poland, 44-190 Szpital W Knurowie Sp. Z O.O.Knurow, Poland, 44-190 Centrum Badan Klinicznych JciKrakow, Poland, 30-348 Marta Dagmara Banach Marta Banach Specjalistyczny Gabinet NeurologicznyKrakow, Poland, 30-539 Centrum Medyczne EvitaKrakow, Poland, 31-153 Szpital Specjalistyczny Im. Ludwika Rydygiera W Krakowie Sp. Z O.O.Krakow, Poland, 31-826 Centrum Medyczne Szpital Swietej Rodziny Sp Z O.O.Lodz, Poland, 90-302 Pracownia Endoskopii Centrum Medyczne Szpital Swietej Rodziny Sp Z O.O.Lodz, Poland, 90-302 Medical Magnus ClinicLodz, Poland, 90-552 Wojewodzki Szpital Specjalistyczny Im. Bieganskiego W LodziLodz, Poland, 91-347 Gastromed Sp. Z O.O.Lublin, Poland, 20-582 Ai Centrum Medyczne Sp. Z O.O. Sp.K.Poznan, Poland, 61-113 Korczowski Bartosz Gabinet LekarskiRzeszow, Poland, 35-302 Endoskopia Sp. Z O. O.Sopot, Poland, 81-756 Szpital Sredzki Serca Jezusowego Sp. Z O.O.Sroda Wielkopolska, Poland, 63-000 Ez-Med Sp. Z O.O. Sp.K.Swidnica, Poland, 58-100 Pracownia Endoskopii Szpital MswSzczecin, Poland, 70-001 Twoja Przychodnia Szczecinskie Centrum MedyczneSzczecin, Poland, 71-434 Gastromed Kopon, Zmudzinski I Wspolnicy Sp.J.Torun, Poland, 87-100 Centrum Zdrowia MdmWarszawa, Poland, 00-635 Centrum Diagnostyczno-Lecznicze Barska Sp. Z O. O.Wloclawek, Poland, 87-800 Melita Medical Sp. Z O.O.Wroclaw, Poland, 50-449 Centrum Gastrologiczno HepatologiczneWroclaw, Poland, 50-555 LexmedicaWroclaw, Poland, 53-114 Russian Federation, Sestroretsk Spb Sbih \"City Hospital #40 Of The Kurortnyi Region\"Saint-Petersburg, Sestroretsk, Russian Federation, 197706 Russian Federation Llc \"Alliance Biomedical-Ural Group\"Izhevsk, Russian Federation, 426061 Clinic Of Fsbei He Ksmu Moh RfKrasnodar, Russian Federation, 350072 Llc \"Olla-Med\"Moscow, Russian Federation, 105554 Sechenov University On The Base Of Institute Of Translational Medicine And BiotechnologyMoscow, Russian Federation, 119435 Limited Liability Company \"Medical Center Sibnovomed\"Novosibirsk, Russian Federation, 630005 Federal State Budgetary Scientific Institution \"Scientific Research Institute Of Physiology AndNovosibirsk, Russian Federation, 630117 Clinic At Fsbei He \"Omsk State Medical University\" Moh RfOmsk, Russian Federation, 644050 Llc \"New Clinic\"Pyatigorsk, Russian Federation, 357500 Limited Liability Company \"Riat\"Saint-Petersburg, Russian Federation, 195220 Saint-Petersburg State Budgetary Healthcare Institution \"City Hospital #26\"Saint-Petersburg, Russian Federation, 196247 Private Institution Educational Organization Of Higher EducationSamara, Russian Federation, 443011 Non-State Healthcare Institution 'Railway Clinical Hospital At Samara Station Of Open Joint StockSamara, Russian Federation, 443029 Saint-Petersburg State Budgetary Healthcare Institution \"City Clinical Hospital Of The RighteousSt. Petersburg, Russian Federation, 197706|Tychy, Silesia, Poland, 43-100|Zemun, Beograd, Serbia, 11080|Beograd, Serbia, 11000 Klinicko Bolnicki Centar Zemun, Klinika Za Internu Medicinu,Zemun, Beograd, Serbia, 11080|Beograd, Srbija, Serbia, 11000 Klinicki Centar KragujevacKragujevac, Srbija, Serbia, 34000 Klinicki Centar NisNis, Srbija, Serbia, 18000 Opsta Bolnica SuboticaSubotica, Srbija, Serbia, 24000 Opsta Bolnica \"Djordje Joanovic\", Odeljenje Interno, Odsek GastroenterologijaZrenjanin, Srbija, Serbia, 23000|Banska Bystrica, Slovakia, 975 17 Breznianske Centrum Gastroenterologie S.R.O.Brezno, Slovakia, 97701 Km Management Spol. S.R.O.Nitra, Slovakia, 949 01 Accout Center S.R.O. Gastroenterologicka AmbulanciaSahy, Slovakia, 936 01 Endomed, S.R.O.Vranov Nad Toplou, Slovakia, 093 01|Lenasia, Gauteng, South Africa, 1827 Wits Clinical Research Trial SiteParktown, Gauteng, South Africa, 2193 Wits Clinical Reasearch - Wits Bara Clinical Trial SiteSoweto, Gauteng, South Africa, 2013|Claremont, Western Cape, South Africa, 7708|Santander, Cantabria, Spain, 39008|Madrid, Spain, 28034 Hospital Universitario Virgen Del RocioSevilla, Spain, 41013 Hospital Universitari I Politecnic La FeValencia, Spain, 46026|Bern, Switzerland, Ch - 3012|Tunis, Tunisia, 1007 Habib Thameur HospitalTunis, Tunisia, 1008|Ankara, Turkey, 06100 Ankara Universitesi Tip Fakultesi, Ibn-I Sina HastanesiAnkara, Turkey, 06100 Hacettepe Universitesi Tip FakultesiAnkara, Turkey, 06230 Bezmialem Vakif Universitesi Tip Fakultesi HastanesiIstanbul, Turkey, 34093 Istanbul Universitesi Cerrahpasa Tip FacultesiIstanbul, Turkey, 34098 Istanbul Universitesi Cerrahpasa Tip FakultesiIstanbul, Turkey, 34098 Erciyes Universitesi Tip FakultesiKayseri, Turkey, 38039 Kocaeli Universitesi Tip FakultesiKocaeli, Turkey, 41380 Mersin Universitesi Tip Fakultesi Hastanesi, Ic HastaliklariMersin, Turkey, 33110 Mersin Universitesi Tip Fakultesi HastanesiMersin, Turkey, 33110 Karadeniz Teknik Universitesi Tip Fakultesi, Ic HastaliklariTrabzon, Turkey, 61080 Karadeniz Teknik Universitesi Tip FakultesiTrabzon, Turkey, 61080 Bulent Ecevit Universitesi Tip FakultesiZonguldak, Turkey, 67600|Chernivtsi, Ukraine, 58001 Regional Municipal Institution \"Chernivtsi Regional Clinical Hospital\", Surgery DepartmentChernivtsi, Ukraine, 58001 Traumatology And Orthopedic Center LlcChernivtsi, Ukraine, 58023 Municipal Healthcare Institution Kharkiv City Clinical Hospital #2 N.A. Prof. O.O. ShalimovKharkiv, Ukraine, 61037 Private Enterprise Of Private Manufacturing Company \"Acinus\", Medical And Diagnostic CenterKropyvnytskyi, Ukraine, 25006 Kyiv Municipal Clinical Hospital #18, Proctology DepartmentKyiv, Ukraine, 01030 Medical Center \"Universal Clinic Oberig\" Of \"Kapital\" Llc, Gastro CenterKyiv, Ukraine, 03680 Lviv Clinical Hospital On Railway Transport Of Health Care Center Branch Of Pjsc Ukrainian RailwayLviv, Ukraine, 79007 Vinnytsia City Clinical Hospital No.1Vinnytsia, Ukraine, 21000 Private Small-Scale Enterprise Medical Center \"Pulse\"Vinnytsia, Ukraine, 21001 Vinnytsia Regional Clinical Hospital For War VeteransVinnytsia, Ukraine, 21005 Vinnytsia Regional Clinical Hospital N.A. M.I.PyrohovVinnytsia, Ukraine, 21018|Dubai, United Arab Emirates, 22241 Emirates Specialty HospitalDubai, United Arab Emirates, Po Box 505240|Dothan, Alabama, United States, 36301 Gut P.C., Dba Digestive Health Specialists Of The SoutheastDothan, Alabama, United States, 36305|Beverly Hills, California, United States, 90210 Long Beach Clinical Trial Services, Inc.Long Beach, California, United States, 90806 Entertainment Medical GroupLos Angeles, California, United States, 90036 Gastrointestinal Biosciences Clinical Trials, LlcLos Angeles, California, United States, 90067 Alliance Clinical Research, LlcPoway, California, United States, 92064|Clearwater, Florida, United States, 33756-3839 West Coast Endoscopy CenterClearwater, Florida, United States, 33756 Gastro FloridaClearwater, Florida, United States, 33762 University Of Miami Clinical Research BuildingMiami, Florida, United States, 33136 University Of Miami Crohn'S And Colitis CenterMiami, Florida, United States, 33136 University Of Miami Hospital And ClinicsMiami, Florida, United States, 33136 University Of Miami HospitalMiami, Florida, United States, 33136 Millenia Surgery CenterOrlando, Florida, United States, 32811 Hmd Research LlcOrlando, Florida, United States, 32819|Shawnee Mission, Kansas, United States, 66217|Houma, Louisiana, United States, 70360 Gulf Coast Surgical CenterHouma, Louisiana, United States, 70360 The Hearing Center (Audiology)Houma, Louisiana, United States, 70360|Chevy Chase, Maryland, United States, 20815 Mgg Group Co., Inc., Chevy Chase Clinical ResearchChevy Chase, Maryland, United States, 20815 Capitol ResearchRockville, Maryland, United States, 20850|Boston, Massachusetts, United States, 02115 Mass Eye And Ear, LongwoodBoston, Massachusetts, United States, 02115 Brigham And Women'S HospitalBoston, Massachusetts, United States, 02215 Brigham And Women'S HospitalChestnut Hill, Massachusetts, United States, 02467 Umass Memorial Medical CenterWorcester, Massachusetts, United States, 01655 University Of Massachusetts Medical SchoolWorcester, Massachusetts, United States, 01655|Caro, Michigan, United States, 48723 Clinical Research Institute Of Michigan, LlcChesterfield, Michigan, United States, 48047 Eastside Endoscopy CenterMacomb, Michigan, United States, 48044 Eastside Endoscopy CenterSaint Clair Shores, Michigan, United States, 48081|New York, New York, United States, 10021 New York Presbyterian Hospital - Weill Cornell Medical College (Colonoscopy)New York, New York, United States, 10065 New York Presbyterian Hospital - Weill Cornell Medical College Investigational PharmacyNew York, New York, United States, 10065 Weill Cornell Medical College - New York Presbyterian Hospital (Endoscopy Suite)New York, New York, United States, 10065 Weill Cornell Medical College - New York Presbyterian HospitalNew York, New York, United States, 10065 Digiovanna Institute For Medical Education And ResearchNorth Massapequa, New York, United States, 11758-1853|Chapel Hill, North Carolina, United States, 27514 Unc Hospitals Endoscopy Center At MeadowmontChapel Hill, North Carolina, United States, 27517 University Of North Carolina At Chapel HillChapel Hill, North Carolina, United States, 27599 Gastroenterology Associates Of The Piedmont, PaWinston-Salem, North Carolina, United States, 27103 Pmg Research Of Winston-Salem, LlcWinston-Salem, North Carolina, United States, 27103|Kingsport, Tennessee, United States, 37660 Holston Valley Surgery CenterKingsport, Tennessee, United States, 37660 Vanderbilt University Medical CenterNashville, Tennessee, United States, 37212-1375 Vanderbilt University Medical CenterNashville, Tennessee, United States, 37212-1610 Vanderbilt University Medical Center - Gi Endoscopy LabNashville, Tennessee, United States, 37232-5543 Vanderbilt University Medical CenterNashville, Tennessee, United States, 37232-7610 Vanderbilt University Medical Center - Gi Research RegulatoryNashville, Tennessee, United States, 37232|Arlington, Texas, United States, 76012 Envision Imaging (Cxr)Arlington, Texas, United States, 76012 Texas Clinical Research Institiute, LlcArlington, Texas, United States, 76012 Hermann Drive Surgical HospitalHouston, Texas, United States, 77004 Pearland Surgery CenterHouston, Texas, United States, 77047 Gulf Coast Research Group, LlcHouston, Texas, United States, 77098 Lonestar Endoscopy, LlpSouthlake, Texas, United States, 76092 Texas Digestive Disease ConsultantsSouthlake, Texas, United States, 76092|Fairfax, Virginia, United States, 22031","Alabama|California|Florida|Kansas|Louisiana|Maryland|Massachusetts|Michigan|New York|North Carolina|Tennessee|Texas|Virginia","Australia|Belgium|Bosnia And Herzegovina|Canada|Croatia|Czechia|France|Georgia|Germany|Hungary|Italy|Lebanon|Poland|Serbia|Slovakia|South Africa|Spain|Switzerland|Tunisia|Turkey|Ukraine|United Arab Emirates|United States","New South Wales Concord Repatriation General Hospital|Queensland Mater Misericordiae Ltd|Saint John Of God Subiaco Hospital|Victoria Ballarat Base Hospital|University Hospital Brussels|Javna Zdravstvena Ustanova Univerzitetski Klinicki Centar Republike Srpske,|Manitoba Winnipeg Regional Health Authority - Health Sciences Centre, Winnipeg|Ontario HÃ´pital Montfort|Hrvatska Klinicki Bolnicki Centar Sestre Milosrdnice|Klinicki Bolnicki Centar Rijeka, Odjel Za Gastroenterologiju|Lekarna Altea|Hospital|The First University Clinic Of Tsmu|Paian Med Research Gmbh|Bekes Megyei Kozponti Korhaz, Rethy Pal Tagkorhaz|A.O.U. Policlinico G. Martino|Bari Istituto Di Ricovero E Cura A Carattere Scientifico (Ircss) S. De Bellis|Bs A.O.Spedali Civili|Cz Univ. \"Magna Graecia\" Di Catanzaro|Mb Asst Monza|Milano Asst Rhodense - Ospedale Di Circolo Di Rho|Saint George Hospital University Medical Center|Niepubliczny Zaklad Opieki Zdrowotnej All-Medicus|Silesia H-T. Centrum Medyczne-Endoterapia|Beograd Klinicko Bolnicki Centar \"Bezanijska Kosa\"|Klinicko Bolnicki Centar Zvezdara, Klinika Za Interne Bolesti,|Srbija Klinicki Centar Srbije, Klinika Za Gastroenterohepatologiju|Fakultna Nemocnica S Poliklinikou F.D. Roosevelta Banska Bystrica|, Gauteng Lenasia Clinical Trial Centre|, Western Cape Dr Wright Private Practice|Cantabria Hospital Universitario Marques De Valdecilla|Hospital Universitario Ramon Y Cajal|Verein Ibd Study Group|La Rabta Hospital|Ankara Universitesi Tip Fakultesi, Ibn-I Sina Hastanesi, Ic Hastaliklari Anabilim Dali,|Regional Municipal Institution \"Chernivtsi Regional Clinical Hospital\", Gastroenterology Department,|Al Baraha Hospital - Moh|Dothan Surgery Center|Brighton Surgical Center|Gastro Florida|Westglen Gastrointestinal Consultants, P.A.|Cronola, Llc|Chevy Chase Endoscopy Center|Brigham And Women's Hospital|Caro Health Plaza|Weill Cornell Medical College (Clinical Site)|Unc Hospitals|Holston Medical Group|Cross Timbers Surgery Center L.P. (Colonoscopy)|Verity Research, Inc.",{"$nulls":3},"Pfizer CT.gov Call Center","2019-05-23","2020-05-25T16:36:05.707","2020-05-26T17:10:42.972","NCT03395184"]
["5ecbf3f5feab101b1553083b","NCT03395184","2019-05-30","Pfizer","PFE","Recruiting","Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PFâ€‘06700841 In Subjects With Moderate To Severe Crohn's Disease","Brepocitinib|Pf-06651600","JAK1 Inhibitor|TYK2 Inhibitor|JAK1 Inhibitor|JAK3 Inhibitor","Yes","['Brepocitinib', 'Pf-06651600']","Yes","['TYK2 Inhibitor', 'JAK3 Inhibitor']","Phase 2",2,250,"Anticipated","2018-02-02","2020-02-04","DAS","Disease Activity Score",{"$nulls":3},"The objectives of this study are to evaluate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-06651600 (200 mg for 8 weeks followed by 50 mg for 4 weeks) dosed once daily and PF-06700841 (60 mg for 12 weeks) dosed once daily during an induction period of 12 weeks, followed by an open label extension period at doses of 50 mg and 30 mg of PF 06651600 and PF 06700841, respectively, for 52 weeks.",null,"A PHASE 2A, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ORAL PF-06651600 AND PF-06700841 AS INDUCTION AND OPEN LABEL EXTENSION TREATMENT IN SUBJECTS WITH MODERATE TO SEVERE CROHN'S DISEASE","B7981007","Crohn's Disease","Crohn Disease","Gastrointestinal Diseases","Gastrointestinal","Experimental","PF-06700841 or placebo|PF-06651600 or placebo",null,"Drug","Placebo PF-06700841|PF-06700841|Placebo PF-06651600|PF-06651600","12 weeks, followed by PF-06700841, 30 mg QD for 52 weeks.|60 mg QD for 12 weeks followed by 30 mg QD for up to 52 weeks|12 weeks, followed by PF-06651600, 50 mg QD for 52 weeks|200 mg QD for 8 weeks, followed by 50 mg QD up to 56 weeks",null,"PF-06700841 or placebo|PF-06651600 or placebo","\n\n 1. Male and/or female subjects 18 years to 75 years of age\n 2. Documented diagnosis of ileal, ileocolonic, or colonic CD with a minimum disease duration of 3 months, as determined by endoscopic and histopathology assessment.\n 3. Endoscopic confirmation of active disease with total SES CD total score of at least 7. For isolated ileal disease, SES CD total score should be at least 4.\n 4. An average daily liquid/soft stool frequency (SF) greater than or equal to 2.5 or daily abdominal pain (AP) greater than or equal to 2.0.\n 5. Must have inadequate response to, loss of response to, or intolerance to at least one conventional therapy for CD:â€¢Steroids; Immunosuppressants (azathioprine [AZA], 6 MP, or methotrexate [MTX]); Anti TNF inhibitors (infliximab, adalimumab,certolizumab); Anti integrin inhibitors (eg, vedolizumab); Anti IL 12/23 inhibitor (ustekinumab).\n    \n    \n 6. Subjects currently receiving the following treatment for CD are eligible providing they have been on stable doses as described below: * Oral corticosteroids (prednisone or equivalent up to 25 mg/day; budesonide up to 9 mg/day). Stable dose for at least 2 weeks prior to baseline. If oral corticosteroids have been recently discontinued, they must have been stopped at least 2 weeks prior to baseline. Decreases in steroid use due to AEs are allowed.\n     * Oral 5 ASA or sulfasalazine are allowed providing that the dose is stable for at least 4 weeks prior to baseline.\n     * Crohn's disease related antibiotics are allowed providing that the dose is stable for at least 4 weeks prior to baseline. If antibiotics are stopped prior to baseline, they must be discontinued at least 4 days prior to baseline.\n    \n    \n\n","\n\n 1.  Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, diverticular disease, ulcerative colitis (UC), or clinical findings suggestive of UC.\n 2.  Presence of active (draining) fistulae or intra abdominal or perineal abscesses.\n 3.  Strictures with obstructive symptoms.\n 4.  Short bowel syndrome.\n 5.  History of bowel perforation requiring surgical intervention within the past 12 months.\n 6.  Previous bowel surgery resulting in an existing stoma. Subjects who have a j pouch are excluded, as a j pouch can result in a stoma.\n 7.  History of bowel surgery within 6 months prior to baseline.\n 8.  Subjects displaying clinical signs of fulminant colitis or toxic megacolon.\n 9.  Subjects with primary sclerosing cholangitis.\n 10. Subjects with evidence of colonic adenomas, dysplasia or neoplasia.\n 11. Abnormal findings on the chest x ray film such as presence of tuberculosis (TB), general infections, heart failure, or malignancy.\n 12. Any history of either untreated or inadequately treated latent or active TB infection, current treatment for active or latent TB infection or evidence of currently active TB by chest x ray, residing with or frequent close contact with individual(s) with active TB.\n 13. Subjects receiving the following therapies within the time period described below or expected to receive any of these therapies during the study period: 1.  >9 mg/day of oral budesonide or >25 mg/day of prednisone or equivalent oral systemic corticosteroid dose within 2 weeks prior to baseline.\n      2.  IV, IM (parenteral), or topical (rectal) treatment of 5 ASA or corticosteroid enemas/suppositories within 2 weeks prior to baseline.\n      3.  Azathioprine, 6 mercaptopurine, or methotrexate within 2 weeks prior to baseline.\n      4.  Anti TNF inhibitors (or biosimilars thereof) as described below: * Infliximab within 8 weeks prior to baseline;\n           * Adalimumab within 8 weeks prior to baseline;\n           * Certolizumab within 8 weeks prior to baseline;\n          \n          \n      5.  Anti integrin inhibitors (eg, vedolizumab) within 8 weeks prior to baseline.\n      6.  Ustekinumab within 8 weeks prior to baseline.\n      7.  Interferon therapy within 8 weeks prior to baseline.\n      8.  Subjects with prior treatment with lymphocyte depleting agents/therapies within 1 year prior to baseline (eg, CamPath[alemtuzumab], alkylating agents [eg, cyclophosphamide or chlorambucil], total lymphoid irradiation, etc).\n      9.  Subjects who have received rituximab or other selective B lymphocyte depleting agents within 1 year prior to baseline.\n      10. Subjects previously receiving leukocyte apheresis, including selective lymphocyte, monocyte, or granulocyte apheresis, or plasma exchange within 6 months prior to baseline.\n      11. Other marketed immunosuppressants or biologics with immunomodulatory properties within 3 months prior to baseline.\n      12. Subjects who have received other JAK inhibitors within 3 months prior to baseline.\n      13. Subjects who have not responded to or have been intolerant of other JAK inhibitors.\n      14. Other investigational procedures(s) or product(s), such as immunosuppressants used in transplantation (eg, mycophenolate mofetil, cyclosporine, rapamycin, or tacrolimus) or live (attenuated) vaccine within 30 days prior to baseline.","TNF","tumor necrosis factor","Protein","Lung, Breast, Ovary","Actual","2018-01-10","Actual","Anticipated","2021-02-18","Anticipated","2019-05-01","2017-12-05","2018-01-03","2019-05-28","Yes",null,"Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years","75 Years","All",null,"No","Yes\nPfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",null,"URL: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7981007&StudyName=A+Phase+2a%2C+Double-blind%2C+Randomized%2C+Placebo-controlled%2C+Parallel+Group+Study+To+Evaluate+The+Efficacy+And+Safety+Of+Oral+Pf-06651600+And+Pf-06700841+As+Induction+And+Open+Label+Extension+Treatment+In+Subjects+With+Moderate+To+Severe+Crohn%E2%80%99s+Disease [https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7981007&StudyName=A+Phase+2a%2C+Double-blind%2C+Randomized%2C+Placebo-controlled%2C+Parallel+Group+Study+To+Evaluate+The+Efficacy+And+Safety+Of+Oral+Pf-06651600+And+Pf-06700841+As+Induction+And+Open+Label+Extension+Treatment+In+Subjects+With+Moderate+To+Severe+Crohn%E2%80%99s+Disease] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To obtain contact information for a study center near you, click here.",null,"Yes","No",{"$nulls":17},"2017-003359-43|PIZZICATO","EudraCT Number|Alias Study Number","Proportion of subjects achieving clinically meaningful endoscopic improvement (reduction of more than or equal to 3 points from baseline in Simplified Endoscopic Activity Score for Crohn's Disease (SES-CD) at Week 12","12 weeks",null,"Number of participants with potentially clinically important serious infections findings|Mean change from baseline in SES-CD score at Week 12.|Proportion of subjects achieving SES-CD 25 and SES-CD 50 at Week 12.|Proportion of subjects achieving endoscopic remission (SES-CD less than or equal to 2) at Week 12.|Proportion of subjects achieving mucosal healing at Week 12.|Number of subjects with adverse events|Number of subjects with serious adverse events|Number of subjects with electrocardiogram findings of potential clinical importance.|Number of subjects withdrawal due to adverse events|Number of subjects with vital signs findings of potential clinical importance.|Number of subjects with laboratory tests findings of potential clinical importance.|Proportion of subjects achieving SES CD 25 and SES CD 50 at Week 64 among subjects who achieved SES CD 25 and SES CD 50 at week 12 respectively.|Proportion of subjects achieving clinically meaningful endoscopic improvement (CMEI response) at week 64 among subjects who achieved CMEI response at Week 12.","64 weeks|Baseline, week 12|Number of subjects achieving SES-CD 25 and SES-CD 50 at Week 12.|Number of subjects achieving endoscopic remission (SES-CD less than or equal to 2) at Week 12.|Number of subjects achieving mucosal healing at Week 12.|Number of participants with reported adverse events|Number of participants with reported serious adverse events|Number of participants with potentially clinically important electrocardiogram findings.|Number of subjects withdrawal due to adverse events.|Number of participants with potentially clinically important vital signs findings.|Number of participants with potentially clinically important laboratory findings.|Number of subjects achieving SES-CD 25 and SES-CD 50 at Week 64 among subjects who achieved SES CD 25 and SES CD 50 at week 12|Number of subject achieving clinically meaningful endoscopic improvement (CMEI response) at week 64 among subjects who achieved CMEI response at week 12.","Baseline, week 12|Week 12|Baseline up to 64 weeks|Baseline u to 64 weeks|week 64","ClinicalTrials.gov_Inquiries@pfizer.com","Pfizer CT.gov Call Center","1-800-718-1021","Concord, New South Wales, Australia, 2139|South Brisbane, Queensland, Australia, 4101|Subiaco, Western|Ballarat, Victoria, Australia, 3350|Wien, Austria, 1090|Jette, Belgium, 1090 University Hospitals LeuvenLeuven, Belgium, 3000 Chc - Saint-JosephLiÃ¨ge, Belgium, 4000|Banja Luka, Bosnia And Herzegovina, 78000 Sveucilisna Klinicka Bolnica Mostar,Mostar, Bosnia And Herzegovina, 88000|Winnipeg, Manitoba, Canada, R3A 1R9|Ottawa, Ontario, Canada, K1K 0T2|Zagreb, Hrvatska, Croatia, 10000|Rijeka, Croatia, 51000 Klinicki Bolnicki Centar Split, Zavod Za GastroenterologijuSplit, Croatia, 21000 Opca Bolnica Zadar, Odjel Za GastroenterologijuZadar, Croatia, 23000 Klinicka Bolnica Dubrava ZagrebZagreb, Croatia, 10000 Klinicki Bolnicki Centar Zagreb, Zavod Za Gastroenterologiju I HepatologijuZagreb, Croatia, 10000|Bilina, Czechia, 41801 Nemocnice Horovice, A.S.Horovice, Czechia, 268 31 Hepato-Gastroenterologie Hk S.R.O.Hradec Kralove, Czechia, 500 12 Medialpharma S.R.O.Hradec Kralove, Czechia, 500 12 Gastroenterologicka Ambulance A EndoskopieMost, Czechia, 43401 Vseobecna Fakultni NemocnicePraha 2, Czechia, 128 08 VÅ¡eobecnÃ¡ FakultnÃ­ Nemocnice V PrazePraha 2, Czechia, 128 08 Nemocnice Strakonice, A.S., Interni OddeleniStrakonice, Czechia, 386 01 Nemocnice Strakonice, A.S.Strakonice, Czechia, 386 29|Achrafieh, Beirut, Lebanon|Tbilisi, Georgia, 0141 David Tatishvili Medical CenterTbilisi, Georgia, 0186|Berlin, Germany, 10318 Krankenhaus Waldfriede E.V.,Berlin, Germany, 14163 Universitaetsklinikum BonnBonn, Germany, 53127 Universitaetsklinikum Schleswig-HolsteinKiel, Germany, 24105|Bekescsaba, Hungary, 5600 Semmelweis Egyetem, Ii. Belgyogyaszati KlinikaBudapest, Hungary, 1088 Szent Janos Korhaz Es Eszak-Budai Egyesitett KorhazakBudapest, Hungary, 1125 Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz, Endoszkopos LaboratoriumGyula, Hungary, 5700 Clinfan Szolgaltato Kft.Szekszard, Hungary, 7100 Csolnoky Ferenc Korhaz Belgyogyaszati Centrum I. Belgyogyaszati OsztalyVeszprem, Hungary, 8200|Messina, Italy, 98125 Istituto Clinico Humanitas Irccs - Ibd CenterMilan, Italy, 20089 Aou Policlinico Di ModenaModena, Italy, 41124 Azienda Ospedaliera Di PadovaPadova, Italy, 35128 Policlinico Universitario Campus Bio-MedicoRoma, Italy, 00128 Policlinico Gemelli/Complesso Integrato ColumbusRome, Italy, 00168 Korea, Republic Of, Korea Kyungpook National University HospitalDaegu, Korea, Korea, Republic Of, 41944 Korea, Republic Of Kyung Hee University HospitalSeoul, Korea, Republic Of, 02447 Kangbuk Samsung HospitalSeoul, Korea, Republic Of, 03181 Severance Hospital, Yonsei University Health SystemSeoul, Korea, Republic Of, 03722 The Catholic University Of Korea, Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591|Castellana Grotte, Bari, Italy, 70013|Brescia, Bs, Italy, 25123|Catanzaro, Cz, Italy, 88100|Monza, Mb, Italy, 20090|Rho, Milano, Italy, 20017|Achrafieh, Lebanon American University Of Beirut Medical CenterBeirut, Lebanon Ain Wazein Medical VillageEl Chouf, Lebanon Centre Hospitalier Universitaire Notre Dame De SecoursJbeil, Lebanon Hammoud Hospital University Medical CenterSaida, Lebanon|Katowice, Poland, 40-659 Etg KielceKielce, Poland, 25-355 Indywidualna Specjalistyczna Praktyka Lekarska Maciej ZymlaKnurow, Poland, 44-190 Szpital W Knurowie Sp. Z O.O.Knurow, Poland, 44-190 Centrum Badan Klinicznych JciKrakow, Poland, 30-348 Marta Dagmara Banach Marta Banach Specjalistyczny Gabinet NeurologicznyKrakow, Poland, 30-539 Centrum Medyczne EvitaKrakow, Poland, 31-153 Szpital Specjalistyczny Im. Ludwika Rydygiera W Krakowie Sp. Z O.O.Krakow, Poland, 31-826 Centrum Medyczne Szpital Swietej Rodziny Sp Z O.O.Lodz, Poland, 90-302 Pracownia Endoskopii Centrum Medyczne Szpital Swietej Rodziny Sp Z O.O.Lodz, Poland, 90-302 Medical Magnus ClinicLodz, Poland, 90-552 Wojewodzki Szpital Specjalistyczny Im. Bieganskiego W LodziLodz, Poland, 91-347 Gastromed Sp. Z O.O.Lublin, Poland, 20-582 Ai Centrum Medyczne Sp. Z O.O. Sp.K.Poznan, Poland, 61-113 Korczowski Bartosz Gabinet LekarskiRzeszow, Poland, 35-302 Endoskopia Sp. Z O. O.Sopot, Poland, 81-756 Szpital Sredzki Serca Jezusowego Sp. Z O.O.Sroda Wielkopolska, Poland, 63-000 Ez-Med Sp. Z O.O. Sp.K.Swidnica, Poland, 58-100 Pracownia Endoskopii Szpital MswSzczecin, Poland, 70-001 Twoja Przychodnia Szczecinskie Centrum MedyczneSzczecin, Poland, 71-434 Gastromed Kopon, Zmudzinski I Wspolnicy Sp.J.Torun, Poland, 87-100 Centrum Zdrowia MdmWarszawa, Poland, 00-635 Centrum Diagnostyczno-Lecznicze Barska Sp. Z O. O.Wloclawek, Poland, 87-800 Melita Medical Sp. Z O.O.Wroclaw, Poland, 50-449 Centrum Gastrologiczno HepatologiczneWroclaw, Poland, 50-555 LexmedicaWroclaw, Poland, 53-114 Russian Federation, Sestroretsk Spb Sbih \"City Hospital #40 Of The Kurortnyi Region\"Saint-Petersburg, Sestroretsk, Russian Federation, 197706 Russian Federation Llc \"Alliance Biomedical-Ural Group\"Izhevsk, Russian Federation, 426061 Clinic Of Fsbei He Ksmu Moh RfKrasnodar, Russian Federation, 350072 Llc \"Olla-Med\"Moscow, Russian Federation, 105554 Sechenov University On The Base Of Institute Of Translational Medicine And BiotechnologyMoscow, Russian Federation, 119435 Limited Liability Company \"Medical Center Sibnovomed\"Novosibirsk, Russian Federation, 630005 Federal State Budgetary Scientific Institution \"Scientific Research Institute Of Physiology AndNovosibirsk, Russian Federation, 630117 Clinic At Fsbei He \"Omsk State Medical University\" Moh RfOmsk, Russian Federation, 644050 Llc \"New Clinic\"Pyatigorsk, Russian Federation, 357500 Limited Liability Company \"Riat\"Saint-Petersburg, Russian Federation, 195220 Saint-Petersburg State Budgetary Healthcare Institution \"City Hospital #26\"Saint-Petersburg, Russian Federation, 196247 Private Institution Educational Organization Of Higher EducationSamara, Russian Federation, 443011 Non-State Healthcare Institution 'Railway Clinical Hospital At Samara Station Of Open Joint StockSamara, Russian Federation, 443029 Saint-Petersburg State Budgetary Healthcare Institution \"City Clinical Hospital Of The RighteousSt. Petersburg, Russian Federation, 197706|Tychy, Silesia, Poland, 43-100|Zemun, Beograd, Serbia, 11080|Beograd, Serbia, 11000 Klinicko Bolnicki Centar Zemun, Klinika Za Internu Medicinu,Zemun, Beograd, Serbia, 11080|Beograd, Srbija, Serbia, 11000 Klinicki Centar KragujevacKragujevac, Srbija, Serbia, 34000 Klinicki Centar NisNis, Srbija, Serbia, 18000 Opsta Bolnica SuboticaSubotica, Srbija, Serbia, 24000 Opsta Bolnica \"Djordje Joanovic\", Odeljenje Interno, Odsek GastroenterologijaZrenjanin, Srbija, Serbia, 23000|Banska Bystrica, Slovakia, 975 17 Breznianske Centrum Gastroenterologie S.R.O.Brezno, Slovakia, 97701 Km Management Spol. S.R.O.Nitra, Slovakia, 949 01 Accout Center S.R.O. Gastroenterologicka AmbulanciaSahy, Slovakia, 936 01 Endomed, S.R.O.Vranov Nad Toplou, Slovakia, 093 01|Lenasia, Gauteng, South Africa, 1827 Wits Clinical Research Trial SiteParktown, Gauteng, South Africa, 2193 Wits Clinical Reasearch - Wits Bara Clinical Trial SiteSoweto, Gauteng, South Africa, 2013|Claremont, Western Cape, South Africa, 7708|Santander, Cantabria, Spain, 39008|Madrid, Spain, 28034 Hospital Universitario Virgen Del RocioSevilla, Spain, 41013 Hospital Universitari I Politecnic La FeValencia, Spain, 46026|Bern, Switzerland, Ch - 3012|Tunis, Tunisia, 1007 Habib Thameur HospitalTunis, Tunisia, 1008|Ankara, Turkey, 06100 Ankara Universitesi Tip Fakultesi, Ibn-I Sina HastanesiAnkara, Turkey, 06100 Hacettepe Universitesi Tip FakultesiAnkara, Turkey, 06230 Bezmialem Vakif Universitesi Tip Fakultesi HastanesiIstanbul, Turkey, 34093 Istanbul Universitesi Cerrahpasa Tip FacultesiIstanbul, Turkey, 34098 Istanbul Universitesi Cerrahpasa Tip FakultesiIstanbul, Turkey, 34098 Erciyes Universitesi Tip FakultesiKayseri, Turkey, 38039 Kocaeli Universitesi Tip FakultesiKocaeli, Turkey, 41380 Mersin Universitesi Tip Fakultesi Hastanesi, Ic HastaliklariMersin, Turkey, 33110 Mersin Universitesi Tip Fakultesi HastanesiMersin, Turkey, 33110 Karadeniz Teknik Universitesi Tip Fakultesi, Ic HastaliklariTrabzon, Turkey, 61080 Karadeniz Teknik Universitesi Tip FakultesiTrabzon, Turkey, 61080 Bulent Ecevit Universitesi Tip FakultesiZonguldak, Turkey, 67600|Chernivtsi, Ukraine, 58001 Regional Municipal Institution \"Chernivtsi Regional Clinical Hospital\", Surgery DepartmentChernivtsi, Ukraine, 58001 Traumatology And Orthopedic Center LlcChernivtsi, Ukraine, 58023 Municipal Healthcare Institution Kharkiv City Clinical Hospital #2 N.A. Prof. O.O. ShalimovKharkiv, Ukraine, 61037 Private Enterprise Of Private Manufacturing Company \"Acinus\", Medical And Diagnostic CenterKropyvnytskyi, Ukraine, 25006 Kyiv Municipal Clinical Hospital #18, Proctology DepartmentKyiv, Ukraine, 01030 Medical Center \"Universal Clinic Oberig\" Of \"Kapital\" Llc, Gastro CenterKyiv, Ukraine, 03680 Lviv Clinical Hospital On Railway Transport Of Health Care Center Branch Of Pjsc Ukrainian RailwayLviv, Ukraine, 79007 Vinnytsia City Clinical Hospital No.1Vinnytsia, Ukraine, 21000 Private Small-Scale Enterprise Medical Center \"Pulse\"Vinnytsia, Ukraine, 21001 Vinnytsia Regional Clinical Hospital For War VeteransVinnytsia, Ukraine, 21005 Vinnytsia Regional Clinical Hospital N.A. M.I.PyrohovVinnytsia, Ukraine, 21018|Dubai, United Arab Emirates, 22241 Emirates Specialty HospitalDubai, United Arab Emirates, Po Box 505240|Dothan, Alabama, United States, 36301 Gut P.C., Dba Digestive Health Specialists Of The SoutheastDothan, Alabama, United States, 36305|Beverly Hills, California, United States, 90210 Long Beach Clinical Trial Services, Inc.Long Beach, California, United States, 90806 Entertainment Medical GroupLos Angeles, California, United States, 90036 Gastrointestinal Biosciences Clinical Trials, LlcLos Angeles, California, United States, 90067 Alliance Clinical Research, LlcPoway, California, United States, 92064|Clearwater, Florida, United States, 33756-3839 West Coast Endoscopy CenterClearwater, Florida, United States, 33756 Gastro FloridaClearwater, Florida, United States, 33762 University Of Miami Clinical Research BuildingMiami, Florida, United States, 33136 University Of Miami Crohn'S And Colitis CenterMiami, Florida, United States, 33136 University Of Miami Hospital And ClinicsMiami, Florida, United States, 33136 University Of Miami HospitalMiami, Florida, United States, 33136 Millenia Surgery CenterOrlando, Florida, United States, 32811 Hmd Research LlcOrlando, Florida, United States, 32819|Shawnee Mission, Kansas, United States, 66217|Houma, Louisiana, United States, 70360 Gulf Coast Surgical CenterHouma, Louisiana, United States, 70360 The Hearing Center (Audiology)Houma, Louisiana, United States, 70360|Chevy Chase, Maryland, United States, 20815 Mgg Group Co., Inc., Chevy Chase Clinical ResearchChevy Chase, Maryland, United States, 20815 Capitol ResearchRockville, Maryland, United States, 20850|Boston, Massachusetts, United States, 02115 Mass Eye And Ear, LongwoodBoston, Massachusetts, United States, 02115 Brigham And Women'S HospitalBoston, Massachusetts, United States, 02215 Brigham And Women'S HospitalChestnut Hill, Massachusetts, United States, 02467 Umass Memorial Medical CenterWorcester, Massachusetts, United States, 01655 University Of Massachusetts Medical SchoolWorcester, Massachusetts, United States, 01655|Caro, Michigan, United States, 48723 Clinical Research Institute Of Michigan, LlcChesterfield, Michigan, United States, 48047 Eastside Endoscopy CenterMacomb, Michigan, United States, 48044 Eastside Endoscopy CenterSaint Clair Shores, Michigan, United States, 48081|New York, New York, United States, 10021 New York Presbyterian Hospital - Weill Cornell Medical College (Colonoscopy)New York, New York, United States, 10065 New York Presbyterian Hospital - Weill Cornell Medical College Investigational PharmacyNew York, New York, United States, 10065 Weill Cornell Medical College - New York Presbyterian Hospital (Endoscopy Suite)New York, New York, United States, 10065 Weill Cornell Medical College - New York Presbyterian HospitalNew York, New York, United States, 10065 Digiovanna Institute For Medical Education And ResearchNorth Massapequa, New York, United States, 11758-1853|Chapel Hill, North Carolina, United States, 27514 Unc Hospitals Endoscopy Center At MeadowmontChapel Hill, North Carolina, United States, 27517 University Of North Carolina At Chapel HillChapel Hill, North Carolina, United States, 27599 Gastroenterology Associates Of The Piedmont, PaWinston-Salem, North Carolina, United States, 27103 Pmg Research Of Winston-Salem, LlcWinston-Salem, North Carolina, United States, 27103|Kingsport, Tennessee, United States, 37660 Holston Valley Surgery CenterKingsport, Tennessee, United States, 37660 Vanderbilt University Medical CenterNashville, Tennessee, United States, 37212-1375 Vanderbilt University Medical CenterNashville, Tennessee, United States, 37212-1610 Vanderbilt University Medical Center - Gi Endoscopy LabNashville, Tennessee, United States, 37232-5543 Vanderbilt University Medical CenterNashville, Tennessee, United States, 37232-7610 Vanderbilt University Medical Center - Gi Research RegulatoryNashville, Tennessee, United States, 37232|Arlington, Texas, United States, 76012 Envision Imaging (Cxr)Arlington, Texas, United States, 76012 Texas Clinical Research Institiute, LlcArlington, Texas, United States, 76012 Hermann Drive Surgical HospitalHouston, Texas, United States, 77004 Pearland Surgery CenterHouston, Texas, United States, 77047 Gulf Coast Research Group, LlcHouston, Texas, United States, 77098 Lonestar Endoscopy, LlpSouthlake, Texas, United States, 76092 Texas Digestive Disease ConsultantsSouthlake, Texas, United States, 76092|Fairfax, Virginia, United States, 22031","Alabama|California|Florida|Kansas|Louisiana|Maryland|Massachusetts|Michigan|New York|North Carolina|Tennessee|Texas|Virginia","Australia|Austria|Belgium|Bosnia And Herzegovina|Canada|Croatia|Czechia|France|Georgia|Germany|Hungary|Italy|Lebanon|Poland|Serbia|Slovakia|South Africa|Spain|Switzerland|Tunisia|Turkey|Ukraine|United Arab Emirates|United States","New South Wales Concord Repatriation General Hospital|Queensland Mater Misericordiae Ltd|Saint John Of God Subiaco Hospital|Victoria Ballarat Base Hospital|Akh Wien Universitaetsklinik Fuer Innere Medizin Iii|University Hospital Brussels|Javna Zdravstvena Ustanova Univerzitetski Klinicki Centar Republike Srpske,|Manitoba Winnipeg Regional Health Authority - Health Sciences Centre, Winnipeg|Ontario HÃ´pital Montfort|Hrvatska Klinicki Bolnicki Centar Sestre Milosrdnice|Klinicki Bolnicki Centar Rijeka, Odjel Za Gastroenterologiju|Lekarna Altea|Hospital|The First University Clinic Of Tsmu|Paian Med Research Gmbh|Bekes Megyei Kozponti Korhaz, Rethy Pal Tagkorhaz|A.O.U. Policlinico G. Martino|Bari Istituto Di Ricovero E Cura A Carattere Scientifico (Ircss) S. De Bellis|Bs A.O.Spedali Civili|Cz Univ. \"Magna Graecia\" Di Catanzaro|Mb Asst Monza|Milano Asst Rhodense - Ospedale Di Circolo Di Rho|Saint George Hospital University Medical Center|Niepubliczny Zaklad Opieki Zdrowotnej All-Medicus|Silesia H-T. Centrum Medyczne-Endoterapia|Beograd Klinicko Bolnicki Centar \"Bezanijska Kosa\"|Klinicko Bolnicki Centar Zvezdara, Klinika Za Interne Bolesti,|Srbija Klinicki Centar Srbije, Klinika Za Gastroenterohepatologiju|Fakultna Nemocnica S Poliklinikou F.D. Roosevelta Banska Bystrica|, Gauteng Lenasia Clinical Trial Centre|, Western Cape Dr Wright Private Practice|Cantabria Hospital Universitario Marques De Valdecilla|Hospital Universitario Ramon Y Cajal|Verein Ibd Study Group|La Rabta Hospital|Ankara Universitesi Tip Fakultesi, Ibn-I Sina Hastanesi, Ic Hastaliklari Anabilim Dali,|Regional Municipal Institution \"Chernivtsi Regional Clinical Hospital\", Gastroenterology Department,|Al Baraha Hospital - Moh|Dothan Surgery Center|Brighton Surgical Center|Gastro Florida|Westglen Gastrointestinal Consultants, P.A.|Cronola, Llc|Chevy Chase Endoscopy Center|Brigham And Women's Hospital|Caro Health Plaza|Weill Cornell Medical College (Clinical Site)|Unc Hospitals|Holston Medical Group|Cross Timbers Surgery Center L.P. (Colonoscopy)|Verity Research, Inc.",{"$nulls":3},"Pfizer CT.gov Call Center","2019-05-28","2020-05-25T16:36:05.573","2020-05-26T17:10:42.972","NCT03395184"]
["5ecbf3f5e2561b1b11905d07","NCT03395184","2019-06-14","Pfizer","PFE","Recruiting","Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PFâ€‘06700841 In Subjects With Moderate To Severe Crohn's Disease","Brepocitinib|Pf-06651600","JAK1 Inhibitor|TYK2 Inhibitor|JAK1 Inhibitor|JAK3 Inhibitor","Yes","['Brepocitinib', 'Pf-06651600']","Yes","['TYK2 Inhibitor', 'JAK3 Inhibitor']","Phase 2",2,250,"Anticipated","2018-02-02","2020-02-04","DAS","Disease Activity Score",{"$nulls":3},"The objectives of this study are to evaluate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-06651600 (200 mg for 8 weeks followed by 50 mg for 4 weeks) dosed once daily and PF-06700841 (60 mg for 12 weeks) dosed once daily during an induction period of 12 weeks, followed by an open label extension period at doses of 50 mg and 30 mg of PF 06651600 and PF 06700841, respectively, for 52 weeks.",null,"A PHASE 2A, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ORAL PF-06651600 AND PF-06700841 AS INDUCTION AND OPEN LABEL EXTENSION TREATMENT IN SUBJECTS WITH MODERATE TO SEVERE CROHN'S DISEASE","B7981007","Crohn's Disease","Crohn Disease","Gastrointestinal Diseases","Gastrointestinal","Experimental","PF-06700841 or placebo|PF-06651600 or placebo",null,"Drug","Placebo PF-06700841|PF-06700841|Placebo PF-06651600|PF-06651600","12 weeks, followed by PF-06700841, 30 mg QD for 52 weeks.|60 mg QD for 12 weeks followed by 30 mg QD for up to 52 weeks|12 weeks, followed by PF-06651600, 50 mg QD for 52 weeks|200 mg QD for 8 weeks, followed by 50 mg QD up to 56 weeks",null,"PF-06700841 or placebo|PF-06651600 or placebo","\n\n 1. Male and/or female subjects 18 years to 75 years of age\n 2. Documented diagnosis of ileal, ileocolonic, or colonic CD with a minimum disease duration of 3 months, as determined by endoscopic and histopathology assessment.\n 3. Endoscopic confirmation of active disease with total SES CD total score of at least 7. For isolated ileal disease, SES CD total score should be at least 4.\n 4. An average daily liquid/soft stool frequency (SF) greater than or equal to 2.5 or daily abdominal pain (AP) greater than or equal to 2.0.\n 5. Must have inadequate response to, loss of response to, or intolerance to at least one conventional therapy for CD:â€¢Steroids; Immunosuppressants (azathioprine [AZA], 6 MP, or methotrexate [MTX]); Anti TNF inhibitors (infliximab, adalimumab,certolizumab); Anti integrin inhibitors (eg, vedolizumab); Anti IL 12/23 inhibitor (ustekinumab).\n    \n    \n 6. Subjects currently receiving the following treatment for CD are eligible providing they have been on stable doses as described below: * Oral corticosteroids (prednisone or equivalent up to 25 mg/day; budesonide up to 9 mg/day). Stable dose for at least 2 weeks prior to baseline. If oral corticosteroids have been recently discontinued, they must have been stopped at least 2 weeks prior to baseline. Decreases in steroid use due to AEs are allowed.\n     * Oral 5 ASA or sulfasalazine are allowed providing that the dose is stable for at least 4 weeks prior to baseline.\n     * Crohn's disease related antibiotics are allowed providing that the dose is stable for at least 4 weeks prior to baseline. If antibiotics are stopped prior to baseline, they must be discontinued at least 4 days prior to baseline.\n    \n    \n\n","\n\n 1.  Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, diverticular disease, ulcerative colitis (UC), or clinical findings suggestive of UC.\n 2.  Presence of active (draining) fistulae or intra abdominal or perineal abscesses.\n 3.  Strictures with obstructive symptoms.\n 4.  Short bowel syndrome.\n 5.  History of bowel perforation requiring surgical intervention within the past 12 months.\n 6.  Previous bowel surgery resulting in an existing stoma. Subjects who have a j pouch are excluded, as a j pouch can result in a stoma.\n 7.  History of bowel surgery within 6 months prior to baseline.\n 8.  Subjects displaying clinical signs of fulminant colitis or toxic megacolon.\n 9.  Subjects with primary sclerosing cholangitis.\n 10. Subjects with evidence of colonic adenomas, dysplasia or neoplasia.\n 11. Abnormal findings on the chest x ray film such as presence of tuberculosis (TB), general infections, heart failure, or malignancy.\n 12. Any history of either untreated or inadequately treated latent or active TB infection, current treatment for active or latent TB infection or evidence of currently active TB by chest x ray, residing with or frequent close contact with individual(s) with active TB.\n 13. Subjects receiving the following therapies within the time period described below or expected to receive any of these therapies during the study period: 1.  >9 mg/day of oral budesonide or >25 mg/day of prednisone or equivalent oral systemic corticosteroid dose within 2 weeks prior to baseline.\n      2.  IV, IM (parenteral), or topical (rectal) treatment of 5 ASA or corticosteroid enemas/suppositories within 2 weeks prior to baseline.\n      3.  Azathioprine, 6 mercaptopurine, or methotrexate within 2 weeks prior to baseline.\n      4.  Anti TNF inhibitors (or biosimilars thereof) as described below: * Infliximab within 8 weeks prior to baseline;\n           * Adalimumab within 8 weeks prior to baseline;\n           * Certolizumab within 8 weeks prior to baseline;\n          \n          \n      5.  Anti integrin inhibitors (eg, vedolizumab) within 8 weeks prior to baseline.\n      6.  Ustekinumab within 8 weeks prior to baseline.\n      7.  Interferon therapy within 8 weeks prior to baseline.\n      8.  Subjects with prior treatment with lymphocyte depleting agents/therapies within 1 year prior to baseline (eg, CamPath[alemtuzumab], alkylating agents [eg, cyclophosphamide or chlorambucil], total lymphoid irradiation, etc).\n      9.  Subjects who have received rituximab or other selective B lymphocyte depleting agents within 1 year prior to baseline.\n      10. Subjects previously receiving leukocyte apheresis, including selective lymphocyte, monocyte, or granulocyte apheresis, or plasma exchange within 6 months prior to baseline.\n      11. Other marketed immunosuppressants or biologics with immunomodulatory properties within 3 months prior to baseline.\n      12. Subjects who have received other JAK inhibitors within 3 months prior to baseline.\n      13. Subjects who have not responded to or have been intolerant of other JAK inhibitors.\n      14. Other investigational procedures(s) or product(s), such as immunosuppressants used in transplantation (eg, mycophenolate mofetil, cyclosporine, rapamycin, or tacrolimus) or live (attenuated) vaccine within 30 days prior to baseline.","TNF","tumor necrosis factor","Protein","Lung, Breast, Ovary","Actual","2018-01-10","Actual","Anticipated","2021-02-18","Anticipated","2019-06-01","2017-12-05","2018-01-03","2019-06-13","Yes",null,"Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years","75 Years","All",null,"No","Yes\nPfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",null,"URL: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7981007&StudyName=A+Phase+2a%2C+Double-blind%2C+Randomized%2C+Placebo-controlled%2C+Parallel+Group+Study+To+Evaluate+The+Efficacy+And+Safety+Of+Oral+Pf-06651600+And+Pf-06700841+As+Induction+And+Open+Label+Extension+Treatment+In+Subjects+With+Moderate+To+Severe+Crohn%E2%80%99s+Disease [https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7981007&StudyName=A+Phase+2a%2C+Double-blind%2C+Randomized%2C+Placebo-controlled%2C+Parallel+Group+Study+To+Evaluate+The+Efficacy+And+Safety+Of+Oral+Pf-06651600+And+Pf-06700841+As+Induction+And+Open+Label+Extension+Treatment+In+Subjects+With+Moderate+To+Severe+Crohn%E2%80%99s+Disease] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To obtain contact information for a study center near you, click here.",null,"Yes","No",{"$nulls":17},"2017-003359-43|PIZZICATO","EudraCT Number|Alias Study Number","Proportion of subjects achieving clinically meaningful endoscopic improvement (reduction of more than or equal to 3 points from baseline in Simplified Endoscopic Activity Score for Crohn's Disease (SES-CD) at Week 12","12 weeks",null,"Number of participants with potentially clinically important serious infections findings|Mean change from baseline in SES-CD score at Week 12.|Proportion of subjects achieving SES-CD 25 and SES-CD 50 at Week 12.|Proportion of subjects achieving endoscopic remission (SES-CD less than or equal to 2) at Week 12.|Proportion of subjects achieving mucosal healing at Week 12.|Number of subjects with adverse events|Number of subjects with serious adverse events|Number of subjects with electrocardiogram findings of potential clinical importance.|Number of subjects withdrawal due to adverse events|Number of subjects with vital signs findings of potential clinical importance.|Number of subjects with laboratory tests findings of potential clinical importance.|Proportion of subjects achieving SES CD 25 and SES CD 50 at Week 64 among subjects who achieved SES CD 25 and SES CD 50 at week 12 respectively.|Proportion of subjects achieving clinically meaningful endoscopic improvement (CMEI response) at week 64 among subjects who achieved CMEI response at Week 12.","64 weeks|Baseline, week 12|Number of subjects achieving SES-CD 25 and SES-CD 50 at Week 12.|Number of subjects achieving endoscopic remission (SES-CD less than or equal to 2) at Week 12.|Number of subjects achieving mucosal healing at Week 12.|Number of participants with reported adverse events|Number of participants with reported serious adverse events|Number of participants with potentially clinically important electrocardiogram findings.|Number of subjects withdrawal due to adverse events.|Number of participants with potentially clinically important vital signs findings.|Number of participants with potentially clinically important laboratory findings.|Number of subjects achieving SES-CD 25 and SES-CD 50 at Week 64 among subjects who achieved SES CD 25 and SES CD 50 at week 12|Number of subject achieving clinically meaningful endoscopic improvement (CMEI response) at week 64 among subjects who achieved CMEI response at week 12.","Baseline, week 12|Week 12|Baseline up to 64 weeks|Baseline u to 64 weeks|week 64","ClinicalTrials.gov_Inquiries@pfizer.com","Pfizer CT.gov Call Center","1-800-718-1021","Concord, New South Wales, Australia, 2139|South Brisbane, Queensland, Australia, 4101|Subiaco, Western|Ballarat, Victoria, Australia, 3350|Wien, Austria, 1090|Jette, Belgium, 1090 University Hospitals LeuvenLeuven, Belgium, 3000 Chc - Saint-JosephLiÃ¨ge, Belgium, 4000|Banja Luka, Bosnia And Herzegovina, 78000 Sveucilisna Klinicka Bolnica Mostar,Mostar, Bosnia And Herzegovina, 88000|Winnipeg, Manitoba, Canada, R3A 1R9|Ottawa, Ontario, Canada, K1K 0T2|Zagreb, Hrvatska, Croatia, 10000|Rijeka, Croatia, 51000 Klinicki Bolnicki Centar Split, Zavod Za GastroenterologijuSplit, Croatia, 21000 Opca Bolnica Zadar, Odjel Za GastroenterologijuZadar, Croatia, 23000 Klinicka Bolnica Dubrava ZagrebZagreb, Croatia, 10000 Klinicki Bolnicki Centar Zagreb, Zavod Za Gastroenterologiju I HepatologijuZagreb, Croatia, 10000|Bilina, Czechia, 41801 Nemocnice Horovice, A.S.Horovice, Czechia, 268 31 Hepato-Gastroenterologie Hk S.R.O.Hradec Kralove, Czechia, 500 12 Medialpharma S.R.O.Hradec Kralove, Czechia, 500 12 Gastroenterologicka Ambulance A EndoskopieMost, Czechia, 43401 Vseobecna Fakultni NemocnicePraha 2, Czechia, 128 08 VÅ¡eobecnÃ¡ FakultnÃ­ Nemocnice V PrazePraha 2, Czechia, 128 08 Lekarna Sv. AnnaPraha 3, Czechia, 130 00 Egk S.R.O. - Sanatorium Sv. AnnyPraha 3, Czechia, 13000 Nemocnice Strakonice, A.S., Interni OddeleniStrakonice, Czechia, 386 01 Nemocnice Strakonice, A.S.Strakonice, Czechia, 386 29|Achrafieh, Beirut, Lebanon|Tbilisi, Georgia, 0141 David Tatishvili Medical CenterTbilisi, Georgia, 0186|Berlin, Germany, 10318 Krankenhaus Waldfriede E.V.,Berlin, Germany, 14163 Universitaetsklinikum BonnBonn, Germany, 53127 Universitaetsklinikum Schleswig-HolsteinKiel, Germany, 24105|Bekescsaba, Hungary, 5600 Semmelweis Egyetem, Ii. Belgyogyaszati KlinikaBudapest, Hungary, 1088 Szent Janos Korhaz Es Eszak-Budai Egyesitett KorhazakBudapest, Hungary, 1125 Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz, Endoszkopos LaboratoriumGyula, Hungary, 5700 Clinfan Szolgaltato Kft.Szekszard, Hungary, 7100 Csolnoky Ferenc Korhaz Belgyogyaszati Centrum I. Belgyogyaszati OsztalyVeszprem, Hungary, 8200|Messina, Italy, 98125 Aou Policlinico Di ModenaModena, Italy, 41124 Azienda Ospedaliera Di PadovaPadova, Italy, 35128 Policlinico Universitario Campus Bio-MedicoRoma, Italy, 00128 Policlinico Gemelli/Complesso Integrato ColumbusRome, Italy, 00168 Korea, Republic Of, Korea Kyungpook National University HospitalDaegu, Korea, Korea, Republic Of, 41944 Korea, Republic Of Kyung Hee University HospitalSeoul, Korea, Republic Of, 02447 Kangbuk Samsung HospitalSeoul, Korea, Republic Of, 03181 Severance Hospital, Yonsei University Health SystemSeoul, Korea, Republic Of, 03722 The Catholic University Of Korea, Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591|Castellana Grotte, Bari, Italy, 70013|Brescia, Bs, Italy, 25123|Catanzaro, Cz, Italy, 88100|Monza, Mb, Italy, 20090|Rozzano, Milan, Italy, 20089|Rho, Milano, Italy, 20017|Achrafieh, Lebanon American University Of Beirut Medical CenterBeirut, Lebanon Ain Wazein Medical VillageEl Chouf, Lebanon Centre Hospitalier Universitaire Notre Dame De SecoursJbeil, Lebanon Hammoud Hospital University Medical CenterSaida, Lebanon|Katowice, Poland, 40-659 Etg KielceKielce, Poland, 25-355 Indywidualna Specjalistyczna Praktyka Lekarska Maciej ZymlaKnurow, Poland, 44-190 Szpital W Knurowie Sp. Z O.O.Knurow, Poland, 44-190 Centrum Badan Klinicznych JciKrakow, Poland, 30-348 Marta Dagmara Banach Marta Banach Specjalistyczny Gabinet NeurologicznyKrakow, Poland, 30-539 Centrum Medyczne EvitaKrakow, Poland, 31-153 Szpital Specjalistyczny Im. Ludwika Rydygiera W Krakowie Sp. Z O.O.Krakow, Poland, 31-826 Centrum Medyczne Szpital Swietej Rodziny Sp Z O.O.Lodz, Poland, 90-302 Pracownia Endoskopii Centrum Medyczne Szpital Swietej Rodziny Sp Z O.O.Lodz, Poland, 90-302 Medical Magnus ClinicLodz, Poland, 90-552 Wojewodzki Szpital Specjalistyczny Im. Bieganskiego W LodziLodz, Poland, 91-347 Gastromed Sp. Z O.O.Lublin, Poland, 20-582 Ai Centrum Medyczne Sp. Z O.O. Sp.K.Poznan, Poland, 61-113 Korczowski Bartosz Gabinet LekarskiRzeszow, Poland, 35-302 Endoskopia Sp. Z O. O.Sopot, Poland, 81-756 Szpital Sredzki Serca Jezusowego Sp. Z O.O.Sroda Wielkopolska, Poland, 63-000 Ez-Med Sp. Z O.O. Sp.K.Swidnica, Poland, 58-100 Pracownia Endoskopii Szpital MswSzczecin, Poland, 70-001 Twoja Przychodnia Szczecinskie Centrum MedyczneSzczecin, Poland, 71-434 Gastromed Kopon, Zmudzinski I Wspolnicy Sp.J.Torun, Poland, 87-100 Centrum Zdrowia MdmWarszawa, Poland, 00-635 Centrum Diagnostyczno-Lecznicze Barska Sp. Z O. O.Wloclawek, Poland, 87-800 Melita Medical Sp. Z O.O.Wroclaw, Poland, 50-449 Centrum Gastrologiczno HepatologiczneWroclaw, Poland, 50-555 LexmedicaWroclaw, Poland, 53-114 Russian Federation, Sestroretsk Spb Sbih \"City Hospital #40 Of The Kurortnyi Region\"Saint-Petersburg, Sestroretsk, Russian Federation, 197706 Russian Federation Llc \"Alliance Biomedical-Ural Group\"Izhevsk, Russian Federation, 426061 Clinic Of Fsbei He Ksmu Moh RfKrasnodar, Russian Federation, 350072 Llc \"Olla-Med\"Moscow, Russian Federation, 105554 Sechenov University On The Base Of Institute Of Translational Medicine And BiotechnologyMoscow, Russian Federation, 119435 Limited Liability Company \"Medical Center Sibnovomed\"Novosibirsk, Russian Federation, 630005 Federal State Budgetary Scientific Institution \"Scientific Research Institute Of Physiology AndNovosibirsk, Russian Federation, 630117 Clinic At Fsbei He \"Omsk State Medical University\" Moh RfOmsk, Russian Federation, 644050 Llc \"New Clinic\"Pyatigorsk, Russian Federation, 357500 Limited Liability Company \"Riat\"Saint-Petersburg, Russian Federation, 195220 Saint-Petersburg State Budgetary Healthcare Institution \"City Hospital #26\"Saint-Petersburg, Russian Federation, 196247 Private Institution Educational Organization Of Higher EducationSamara, Russian Federation, 443011 Non-State Healthcare Institution 'Railway Clinical Hospital At Samara Station Of Open Joint StockSamara, Russian Federation, 443029 Saint-Petersburg State Budgetary Healthcare Institution \"City Clinical Hospital Of The RighteousSt. Petersburg, Russian Federation, 197706|Tychy, Silesia, Poland, 43-100|Zemun, Beograd, Serbia, 11080|Beograd, Serbia, 11000 Klinicko Bolnicki Centar Zemun, Klinika Za Internu Medicinu,Zemun, Beograd, Serbia, 11080|Beograd, Srbija, Serbia, 11000 Klinicki Centar KragujevacKragujevac, Srbija, Serbia, 34000 Klinicki Centar NisNis, Srbija, Serbia, 18000 Opsta Bolnica SuboticaSubotica, Srbija, Serbia, 24000 Opsta Bolnica \"Djordje Joanovic\", Odeljenje Interno, Odsek GastroenterologijaZrenjanin, Srbija, Serbia, 23000|Banska Bystrica, Slovakia, 975 17 Breznianske Centrum Gastroenterologie S.R.O.Brezno, Slovakia, 97701 Km Management Spol. S.R.O.Nitra, Slovakia, 949 01 Accout Center S.R.O. Gastroenterologicka AmbulanciaSahy, Slovakia, 936 01 Endomed, S.R.O.Vranov Nad Toplou, Slovakia, 093 01|Lenasia, Gauteng, South Africa, 1827 Wits Clinical Research Trial SiteParktown, Gauteng, South Africa, 2193 Wits Clinical Reasearch - Wits Bara Clinical Trial SiteSoweto, Gauteng, South Africa, 2013|Claremont, Western Cape, South Africa, 7708|Santander, Cantabria, Spain, 39008|Madrid, Spain, 28034 Hospital Universitario Virgen Del RocioSevilla, Spain, 41013 Hospital Universitari I Politecnic La FeValencia, Spain, 46026|Bern, Switzerland, Ch - 3012|Tunis, Tunisia, 1007 Habib Thameur HospitalTunis, Tunisia, 1008|Ankara, Turkey, 06100 Ankara Universitesi Tip Fakultesi, Ibn-I Sina HastanesiAnkara, Turkey, 06100 Hacettepe Universitesi Tip FakultesiAnkara, Turkey, 06230 Bezmialem Vakif Universitesi Tip Fakultesi HastanesiIstanbul, Turkey, 34093 Istanbul Universitesi Cerrahpasa Tip FacultesiIstanbul, Turkey, 34098 Istanbul Universitesi Cerrahpasa Tip FakultesiIstanbul, Turkey, 34098 Erciyes Universitesi Tip FakultesiKayseri, Turkey, 38039 Kocaeli Universitesi Tip FakultesiKocaeli, Turkey, 41380 Mersin Universitesi Tip Fakultesi Hastanesi, Ic HastaliklariMersin, Turkey, 33110 Mersin Universitesi Tip Fakultesi HastanesiMersin, Turkey, 33110 Karadeniz Teknik Universitesi Tip Fakultesi, Ic HastaliklariTrabzon, Turkey, 61080 Karadeniz Teknik Universitesi Tip FakultesiTrabzon, Turkey, 61080 Bulent Ecevit Universitesi Tip FakultesiZonguldak, Turkey, 67600|Chernivtsi, Ukraine, 58001 Regional Municipal Institution \"Chernivtsi Regional Clinical Hospital\", Surgery DepartmentChernivtsi, Ukraine, 58001 Traumatology And Orthopedic Center LlcChernivtsi, Ukraine, 58023 Municipal Healthcare Institution Kharkiv City Clinical Hospital #2 N.A. Prof. O.O. ShalimovKharkiv, Ukraine, 61037 Private Enterprise Of Private Manufacturing Company \"Acinus\", Medical And Diagnostic CenterKropyvnytskyi, Ukraine, 25006 Kyiv Municipal Clinical Hospital #18, Proctology DepartmentKyiv, Ukraine, 01030 Medical Center \"Universal Clinic Oberig\" Of \"Kapital\" Llc, Gastro CenterKyiv, Ukraine, 03680 Lviv Clinical Hospital On Railway Transport Of Health Care Center Branch Of Pjsc Ukrainian RailwayLviv, Ukraine, 79007 Vinnytsia City Clinical Hospital No.1Vinnytsia, Ukraine, 21000 Private Small-Scale Enterprise Medical Center \"Pulse\"Vinnytsia, Ukraine, 21001 Vinnytsia Regional Clinical Hospital For War VeteransVinnytsia, Ukraine, 21005 Vinnytsia Regional Clinical Hospital N.A. M.I.PyrohovVinnytsia, Ukraine, 21018|Dubai, United Arab Emirates, 22241 Emirates Specialty HospitalDubai, United Arab Emirates, Po Box 505240|Dothan, Alabama, United States, 36301 Gut P.C., Dba Digestive Health Specialists Of The SoutheastDothan, Alabama, United States, 36305|Beverly Hills, California, United States, 90210 Long Beach Clinical Trial Services, Inc.Long Beach, California, United States, 90806 Entertainment Medical GroupLos Angeles, California, United States, 90036 Gastrointestinal Biosciences Clinical Trials, LlcLos Angeles, California, United States, 90067 Alliance Clinical Research, LlcPoway, California, United States, 92064|Clearwater, Florida, United States, 33756-3839 West Coast Endoscopy CenterClearwater, Florida, United States, 33756 Gastro FloridaClearwater, Florida, United States, 33762 University Of Miami Clinical Research BuildingMiami, Florida, United States, 33136 University Of Miami Crohn'S And Colitis CenterMiami, Florida, United States, 33136 University Of Miami Hospital And ClinicsMiami, Florida, United States, 33136 University Of Miami HospitalMiami, Florida, United States, 33136 Millenia Surgery CenterOrlando, Florida, United States, 32811 Hmd Research LlcOrlando, Florida, United States, 32819|Shawnee Mission, Kansas, United States, 66217|Houma, Louisiana, United States, 70360 Gulf Coast Surgical CenterHouma, Louisiana, United States, 70360 The Hearing Center (Audiology)Houma, Louisiana, United States, 70360|Chevy Chase, Maryland, United States, 20815 Mgg Group Co., Inc., Chevy Chase Clinical ResearchChevy Chase, Maryland, United States, 20815 Capitol ResearchRockville, Maryland, United States, 20850|Boston, Massachusetts, United States, 02115 Mass Eye And Ear, LongwoodBoston, Massachusetts, United States, 02115 Brigham And Women'S HospitalBoston, Massachusetts, United States, 02215 Brigham And Women'S HospitalChestnut Hill, Massachusetts, United States, 02467 Umass Memorial Medical CenterWorcester, Massachusetts, United States, 01655 University Of Massachusetts Medical SchoolWorcester, Massachusetts, United States, 01655|Caro, Michigan, United States, 48723 Clinical Research Institute Of Michigan, LlcChesterfield, Michigan, United States, 48047 Eastside Endoscopy CenterMacomb, Michigan, United States, 48044 Eastside Endoscopy CenterSaint Clair Shores, Michigan, United States, 48081|New York, New York, United States, 10021 New York Presbyterian Hospital - Weill Cornell Medical College (Colonoscopy)New York, New York, United States, 10065 New York Presbyterian Hospital - Weill Cornell Medical College Investigational PharmacyNew York, New York, United States, 10065 Weill Cornell Medical College - New York Presbyterian Hospital (Endoscopy Suite)New York, New York, United States, 10065 Weill Cornell Medical College - New York Presbyterian HospitalNew York, New York, United States, 10065 Digiovanna Institute For Medical Education And ResearchNorth Massapequa, New York, United States, 11758-1853|Chapel Hill, North Carolina, United States, 27514 Unc Hospitals Endoscopy Center At MeadowmontChapel Hill, North Carolina, United States, 27517 University Of North Carolina At Chapel HillChapel Hill, North Carolina, United States, 27599 Gastroenterology Associates Of The Piedmont, PaWinston-Salem, North Carolina, United States, 27103 Pmg Research Of Winston-Salem, LlcWinston-Salem, North Carolina, United States, 27103|Kingsport, Tennessee, United States, 37660 Holston Valley Surgery CenterKingsport, Tennessee, United States, 37660 Vanderbilt University Medical CenterNashville, Tennessee, United States, 37212-1375 Vanderbilt University Medical CenterNashville, Tennessee, United States, 37212-1610 Vanderbilt University Medical Center - Gi Endoscopy LabNashville, Tennessee, United States, 37232-5543 Vanderbilt University Medical CenterNashville, Tennessee, United States, 37232-7610 Vanderbilt University Medical Center - Gi Research RegulatoryNashville, Tennessee, United States, 37232|Arlington, Texas, United States, 76012 Envision Imaging (Cxr)Arlington, Texas, United States, 76012 Texas Clinical Research Institiute, LlcArlington, Texas, United States, 76012 Hrmd ResearchDallas, Texas, United States, 75240 Hermann Drive Surgical HospitalHouston, Texas, United States, 77004 Pearland Surgery CenterHouston, Texas, United States, 77047 Gulf Coast Research Group, LlcHouston, Texas, United States, 77098 Lonestar Endoscopy, LlpSouthlake, Texas, United States, 76092 Texas Digestive Disease ConsultantsSouthlake, Texas, United States, 76092|Fairfax, Virginia, United States, 22031","Alabama|California|Florida|Kansas|Louisiana|Maryland|Massachusetts|Michigan|New York|North Carolina|Tennessee|Texas|Virginia","Australia|Austria|Belgium|Bosnia And Herzegovina|Canada|Croatia|Czechia|France|Georgia|Germany|Hungary|Italy|Lebanon|Poland|Serbia|Slovakia|South Africa|Spain|Switzerland|Tunisia|Turkey|Ukraine|United Arab Emirates|United States","New South Wales Concord Repatriation General Hospital|Queensland Mater Misericordiae Ltd|Saint John Of God Health Care Inc.|Victoria Ballarat Base Hospital|Akh Wien Universitaetsklinik Fuer Innere Medizin Iii|University Hospital Brussels|Javna Zdravstvena Ustanova Univerzitetski Klinicki Centar Republike Srpske,|Manitoba Winnipeg Regional Health Authority - Health Sciences Centre, Winnipeg|Ontario HÃ´pital Montfort|Hrvatska Klinicki Bolnicki Centar Sestre Milosrdnice|Klinicki Bolnicki Centar Rijeka, Odjel Za Gastroenterologiju|Lekarna Altea|Hospital|The First University Clinic Of Tsmu|Paian Med Research Gmbh|Bekes Megyei Kozponti Korhaz, Rethy Pal Tagkorhaz|A.O.U. Policlinico G. Martino|Bari Irccs Saverio De Bellis|Bs A.O.Spedali Civili|Cz Univ. \"Magna Graecia\" Di Catanzaro|Mb Asst Monza|Milan Istituto Clinico Humanitas Irccs - Ibd Center|Milano Asst Rhodense - Ospedale Di Circolo Di Rho|Saint George Hospital University Medical Center|Niepubliczny Zaklad Opieki Zdrowotnej All-Medicus|Silesia H-T. Centrum Medyczne-Endoterapia|Beograd Klinicko Bolnicki Centar \"Bezanijska Kosa\"|Klinicko Bolnicki Centar Zvezdara, Klinika Za Interne Bolesti,|Srbija Klinicki Centar Srbije, Klinika Za Gastroenterohepatologiju|Fakultna Nemocnica S Poliklinikou F.D. Roosevelta Banska Bystrica|, Gauteng Lenasia Clinical Trial Centre|, Western Cape Dr Wright Private Practice|Cantabria Hospital Universitario Marques De Valdecilla|Hospital Universitario Ramon Y Cajal|Verein Ibd Study Group|La Rabta Hospital|Ankara Universitesi Tip Fakultesi, Ibn-I Sina Hastanesi, Ic Hastaliklari Anabilim Dali,|Regional Municipal Institution \"Chernivtsi Regional Clinical Hospital\", Gastroenterology Department,|Al Baraha Hospital - Moh|Dothan Surgery Center|Brighton Surgical Center|Gastro Florida|Westglen Gastrointestinal Consultants, P.A.|Cronola, Llc|Chevy Chase Endoscopy Center|Brigham And Women's Hospital|Caro Health Plaza|Weill Cornell Medical College (Clinical Site)|Unc Hospitals|Holston Medical Group|Cross Timbers Surgery Center L.P. (Colonoscopy)|Verity Research, Inc.",{"$nulls":3},"Pfizer CT.gov Call Center","2019-06-13","2020-05-25T16:36:05.596","2020-05-26T17:10:42.972","NCT03395184"]
["5ecbf3f5307e3d1b1f8d9c9c","NCT03395184","2019-07-16","Pfizer","PFE","Recruiting","Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PFâ€‘06700841 In Subjects With Moderate To Severe Crohn's Disease","Brepocitinib|Pf-06651600","JAK1 Inhibitor|TYK2 Inhibitor|JAK1 Inhibitor|JAK3 Inhibitor","Yes","['Brepocitinib', 'Pf-06651600']","Yes","['TYK2 Inhibitor', 'JAK3 Inhibitor']","Phase 2",2,250,"Anticipated","2018-02-02","2020-02-04","DAS","Disease Activity Score",{"$nulls":3},"The objectives of this study are to evaluate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-06651600 (200 mg for 8 weeks followed by 50 mg for 4 weeks) dosed once daily and PF-06700841 (60 mg for 12 weeks) dosed once daily during an induction period of 12 weeks, followed by an open label extension period at doses of 50 mg and 30 mg of PF 06651600 and PF 06700841, respectively, for 52 weeks.",null,"A PHASE 2A, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ORAL PF-06651600 AND PF-06700841 AS INDUCTION AND OPEN LABEL EXTENSION TREATMENT IN SUBJECTS WITH MODERATE TO SEVERE CROHN'S DISEASE","B7981007","Crohn's Disease","Crohn Disease","Gastrointestinal Diseases","Gastrointestinal","Experimental","PF-06700841 or placebo|PF-06651600 or placebo",null,"Drug","Placebo PF-06700841|PF-06700841|Placebo PF-06651600|PF-06651600","12 weeks, followed by PF-06700841, 30 mg QD for 52 weeks.|60 mg QD for 12 weeks followed by 30 mg QD for up to 52 weeks|12 weeks, followed by PF-06651600, 50 mg QD for 52 weeks|200 mg QD for 8 weeks, followed by 50 mg QD up to 56 weeks",null,"PF-06700841 or placebo|PF-06651600 or placebo","\n\n 1. Male and/or female subjects 18 years to 75 years of age\n 2. Documented diagnosis of ileal, ileocolonic, or colonic CD with a minimum disease duration of 3 months, as determined by endoscopic and histopathology assessment.\n 3. Endoscopic confirmation of active disease with total SES CD total score of at least 7. For isolated ileal disease, SES CD total score should be at least 4.\n 4. An average daily liquid/soft stool frequency (SF) greater than or equal to 2.5 or daily abdominal pain (AP) greater than or equal to 2.0.\n 5. Must have inadequate response to, loss of response to, or intolerance to at least one conventional therapy for CD:â€¢Steroids; Immunosuppressants (azathioprine [AZA], 6 MP, or methotrexate [MTX]); Anti TNF inhibitors (infliximab, adalimumab,certolizumab); Anti integrin inhibitors (eg, vedolizumab); Anti IL 12/23 inhibitor (ustekinumab).\n    \n    \n 6. Subjects currently receiving the following treatment for CD are eligible providing they have been on stable doses as described below: * Oral corticosteroids (prednisone or equivalent up to 25 mg/day; budesonide up to 9 mg/day). Stable dose for at least 2 weeks prior to baseline. If oral corticosteroids have been recently discontinued, they must have been stopped at least 2 weeks prior to baseline. Decreases in steroid use due to AEs are allowed.\n     * Oral 5 ASA or sulfasalazine are allowed providing that the dose is stable for at least 4 weeks prior to baseline.\n     * Crohn's disease related antibiotics are allowed providing that the dose is stable for at least 4 weeks prior to baseline. If antibiotics are stopped prior to baseline, they must be discontinued at least 4 days prior to baseline.\n    \n    \n\n","\n\n 1.  Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, diverticular disease, ulcerative colitis (UC), or clinical findings suggestive of UC.\n 2.  Presence of active (draining) fistulae or intra abdominal or perineal abscesses.\n 3.  Strictures with obstructive symptoms.\n 4.  Short bowel syndrome.\n 5.  History of bowel perforation requiring surgical intervention within the past 12 months.\n 6.  Previous bowel surgery resulting in an existing stoma. Subjects who have a j pouch are excluded, as a j pouch can result in a stoma.\n 7.  History of bowel surgery within 6 months prior to baseline.\n 8.  Subjects displaying clinical signs of fulminant colitis or toxic megacolon.\n 9.  Subjects with primary sclerosing cholangitis.\n 10. Subjects with evidence of colonic adenomas, dysplasia or neoplasia.\n 11. Abnormal findings on the chest x ray film such as presence of tuberculosis (TB), general infections, heart failure, or malignancy.\n 12. Any history of either untreated or inadequately treated latent or active TB infection, current treatment for active or latent TB infection or evidence of currently active TB by chest x ray, residing with or frequent close contact with individual(s) with active TB.\n 13. Subjects receiving the following therapies within the time period described below or expected to receive any of these therapies during the study period: 1.  >9 mg/day of oral budesonide or >25 mg/day of prednisone or equivalent oral systemic corticosteroid dose within 2 weeks prior to baseline.\n      2.  IV, IM (parenteral), or topical (rectal) treatment of 5 ASA or corticosteroid enemas/suppositories within 2 weeks prior to baseline.\n      3.  Azathioprine, 6 mercaptopurine, or methotrexate within 2 weeks prior to baseline.\n      4.  Anti TNF inhibitors (or biosimilars thereof) as described below: * Infliximab within 8 weeks prior to baseline;\n           * Adalimumab within 8 weeks prior to baseline;\n           * Certolizumab within 8 weeks prior to baseline;\n          \n          \n      5.  Anti integrin inhibitors (eg, vedolizumab) within 8 weeks prior to baseline.\n      6.  Ustekinumab within 8 weeks prior to baseline.\n      7.  Interferon therapy within 8 weeks prior to baseline.\n      8.  Subjects with prior treatment with lymphocyte depleting agents/therapies within 1 year prior to baseline (eg, CamPath[alemtuzumab], alkylating agents [eg, cyclophosphamide or chlorambucil], total lymphoid irradiation, etc).\n      9.  Subjects who have received rituximab or other selective B lymphocyte depleting agents within 1 year prior to baseline.\n      10. Subjects previously receiving leukocyte apheresis, including selective lymphocyte, monocyte, or granulocyte apheresis, or plasma exchange within 6 months prior to baseline.\n      11. Other marketed immunosuppressants or biologics with immunomodulatory properties within 3 months prior to baseline.\n      12. Subjects who have received other JAK inhibitors within 3 months prior to baseline.\n      13. Subjects who have not responded to or have been intolerant of other JAK inhibitors.\n      14. Other investigational procedures(s) or product(s), such as immunosuppressants used in transplantation (eg, mycophenolate mofetil, cyclosporine, rapamycin, or tacrolimus) or live (attenuated) vaccine within 30 days prior to baseline.","TNF","tumor necrosis factor","Protein","Lung, Breast, Ovary","Actual","2018-01-10","Actual","Anticipated","2021-02-18","Anticipated","2019-07-01","2017-12-05","2018-01-03","2019-07-12","Yes",null,"Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years","75 Years","All",null,"No","Yes\nPfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",null,"URL: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7981007&StudyName=A+Phase+2a%2C+Double-blind%2C+Randomized%2C+Placebo-controlled%2C+Parallel+Group+Study+To+Evaluate+The+Efficacy+And+Safety+Of+Oral+Pf-06651600+And+Pf-06700841+As+Induction+And+Open+Label+Extension+Treatment+In+Subjects+With+Moderate+To+Severe+Crohn%E2%80%99s+Disease [https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7981007&StudyName=A+Phase+2a%2C+Double-blind%2C+Randomized%2C+Placebo-controlled%2C+Parallel+Group+Study+To+Evaluate+The+Efficacy+And+Safety+Of+Oral+Pf-06651600+And+Pf-06700841+As+Induction+And+Open+Label+Extension+Treatment+In+Subjects+With+Moderate+To+Severe+Crohn%E2%80%99s+Disease] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To obtain contact information for a study center near you, click here.",null,"Yes","No",{"$nulls":17},"2017-003359-43|PIZZICATO","EudraCT Number|Alias Study Number","Proportion of subjects achieving clinically meaningful endoscopic improvement (reduction of more than or equal to 3 points from baseline in Simplified Endoscopic Activity Score for Crohn's Disease (SES-CD) at Week 12","12 weeks",null,"Number of participants with potentially clinically important serious infections findings|Mean change from baseline in SES-CD score at Week 12.|Proportion of subjects achieving SES-CD 25 and SES-CD 50 at Week 12.|Proportion of subjects achieving endoscopic remission (SES-CD less than or equal to 2) at Week 12.|Proportion of subjects achieving mucosal healing at Week 12.|Number of subjects with adverse events|Number of subjects with serious adverse events|Number of subjects with electrocardiogram findings of potential clinical importance.|Number of subjects withdrawal due to adverse events|Number of subjects with vital signs findings of potential clinical importance.|Number of subjects with laboratory tests findings of potential clinical importance.|Proportion of subjects achieving SES CD 25 and SES CD 50 at Week 64 among subjects who achieved SES CD 25 and SES CD 50 at week 12 respectively.|Proportion of subjects achieving clinically meaningful endoscopic improvement (CMEI response) at week 64 among subjects who achieved CMEI response at Week 12.","64 weeks|Baseline, week 12|Number of subjects achieving SES-CD 25 and SES-CD 50 at Week 12.|Number of subjects achieving endoscopic remission (SES-CD less than or equal to 2) at Week 12.|Number of subjects achieving mucosal healing at Week 12.|Number of participants with reported adverse events|Number of participants with reported serious adverse events|Number of participants with potentially clinically important electrocardiogram findings.|Number of subjects withdrawal due to adverse events.|Number of participants with potentially clinically important vital signs findings.|Number of participants with potentially clinically important laboratory findings.|Number of subjects achieving SES-CD 25 and SES-CD 50 at Week 64 among subjects who achieved SES CD 25 and SES CD 50 at week 12|Number of subject achieving clinically meaningful endoscopic improvement (CMEI response) at week 64 among subjects who achieved CMEI response at week 12.","Baseline, week 12|Week 12|Baseline up to 64 weeks|Baseline u to 64 weeks|week 64","ClinicalTrials.gov_Inquiries@pfizer.com","Pfizer CT.gov Call Center","1-800-718-1021","Concord, New South Wales, Australia, 2139|South Brisbane, Queensland, Australia, 4101|Subiaco, Western|Ballarat, Victoria, Australia, 3350|Wien, Austria, 1090|Jette, Belgium, 1090 University Hospitals LeuvenLeuven, Belgium, 3000 Chc - Saint-JosephLiÃ¨ge, Belgium, 4000|Banja Luka, Bosnia And Herzegovina, 78000 Sveucilisna Klinicka Bolnica Mostar,Mostar, Bosnia And Herzegovina, 88000|Winnipeg, Manitoba, Canada, R3A 1R9|Ottawa, Ontario, Canada, K1K 0T2|Zagreb, Hrvatska, Croatia, 10000|Rijeka, Croatia, 51000 Klinicki Bolnicki Centar Split, Zavod Za GastroenterologijuSplit, Croatia, 21000 Opca Bolnica Zadar, Odjel Za GastroenterologijuZadar, Croatia, 23000 Klinicka Bolnica Dubrava ZagrebZagreb, Croatia, 10000 Klinicki Bolnicki Centar Zagreb, Zavod Za Gastroenterologiju I HepatologijuZagreb, Croatia, 10000|Bilina, Czechia, 41801 Nemocnice Horovice, A.S.Horovice, Czechia, 268 31 Hepato-Gastroenterologie Hk S.R.O.Hradec Kralove, Czechia, 500 12 Medialpharma S.R.O.Hradec Kralove, Czechia, 500 12 Gastroenterologicka Ambulance A EndoskopieMost, Czechia, 43401 Vseobecna Fakultni NemocnicePraha 2, Czechia, 128 08 VÅ¡eobecnÃ¡ FakultnÃ­ Nemocnice V PrazePraha 2, Czechia, 128 08 Lekarna Sv. AnnaPraha 3, Czechia, 130 00 Egk S.R.O. - Sanatorium Sv. AnnyPraha 3, Czechia, 13000 Fakultni Nemocnice V MotolePraha 5, Czechia, 150 06 FakultnÃ­ Nemocnice V MotolePraha 5, Czechia, 150 06 Nemocnice Strakonice, A.S., Interni OddeleniStrakonice, Czechia, 386 01 Nemocnice Strakonice, A.S.Strakonice, Czechia, 386 29|Achrafieh, Beirut, Lebanon|Tbilisi, Georgia, 0141 David Tatishvili Medical CenterTbilisi, Georgia, 0186|Berlin, Germany, 10318 Krankenhaus Waldfriede E.V.,Berlin, Germany, 14163 Universitaetsklinikum BonnBonn, Germany, 53127 Universitaetsklinikum Schleswig-HolsteinKiel, Germany, 24105|Bekescsaba, Hungary, 5600 Semmelweis Egyetem, Ii. Belgyogyaszati KlinikaBudapest, Hungary, 1088 Szent Janos Korhaz Es Eszak-Budai Egyesitett KorhazakBudapest, Hungary, 1125 Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz, Endoszkopos LaboratoriumGyula, Hungary, 5700 Clinfan Szolgaltato Kft.Szekszard, Hungary, 7100 Csolnoky Ferenc Korhaz Belgyogyaszati Centrum I. Belgyogyaszati OsztalyVeszprem, Hungary, 8200|Messina, Italy, 98125 Aou Policlinico Di ModenaModena, Italy, 41124 Azienda Ospedaliera Di PadovaPadova, Italy, 35128 Policlinico Universitario Campus Bio-MedicoRoma, Italy, 00128 Policlinico Gemelli/Complesso Integrato ColumbusRome, Italy, 00168 Korea, Republic Of, Korea Kyungpook National University HospitalDaegu, Korea, Korea, Republic Of, 41944 Korea, Republic Of Kyung Hee University HospitalSeoul, Korea, Republic Of, 02447 Kangbuk Samsung HospitalSeoul, Korea, Republic Of, 03181 Severance Hospital, Yonsei University Health SystemSeoul, Korea, Republic Of, 03722 The Catholic University Of Korea, Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591|Castellana Grotte, Bari, Italy, 70013|Brescia, Bs, Italy, 25123|Catanzaro, Cz, Italy, 88100|Monza, Mb, Italy, 20090|Rozzano, Milan, Italy, 20089|Rho, Milano, Italy, 20017|Achrafieh, Lebanon American University Of Beirut Medical CenterBeirut, Lebanon Ain Wazein Medical VillageEl Chouf, Lebanon Centre Hospitalier Universitaire Notre Dame De SecoursJbeil, Lebanon Hammoud Hospital University Medical CenterSaida, Lebanon|Katowice, Poland, 40-659 Etg KielceKielce, Poland, 25-355 Indywidualna Specjalistyczna Praktyka Lekarska Maciej ZymlaKnurow, Poland, 44-190 Szpital W Knurowie Sp. Z O.O.Knurow, Poland, 44-190 Centrum Badan Klinicznych JciKrakow, Poland, 30-348 Marta Dagmara Banach Marta Banach Specjalistyczny Gabinet NeurologicznyKrakow, Poland, 30-539 Centrum Medyczne EvitaKrakow, Poland, 31-153 Szpital Specjalistyczny Im. Ludwika Rydygiera W Krakowie Sp. Z O.O.Krakow, Poland, 31-826 Centrum Medyczne Szpital Swietej Rodziny Sp Z O.O.Lodz, Poland, 90-302 Pracownia Endoskopii Centrum Medyczne Szpital Swietej Rodziny Sp Z O.O.Lodz, Poland, 90-302 Medical Magnus ClinicLodz, Poland, 90-552 Wojewodzki Szpital Specjalistyczny Im. Bieganskiego W LodziLodz, Poland, 91-347 Gastromed Sp. Z O.O.Lublin, Poland, 20-582 Ai Centrum Medyczne Sp. Z O.O. Sp.K.Poznan, Poland, 61-113 Korczowski Bartosz Gabinet LekarskiRzeszow, Poland, 35-302 Endoskopia Sp. Z O. O.Sopot, Poland, 81-756 Szpital Sredzki Serca Jezusowego Sp. Z O.O.Sroda Wielkopolska, Poland, 63-000 Ez-Med Sp. Z O.O. Sp.K.Swidnica, Poland, 58-100 Pracownia Endoskopii Szpital MswSzczecin, Poland, 70-001 Twoja Przychodnia Szczecinskie Centrum MedyczneSzczecin, Poland, 71-434 Gastromed Kopon, Zmudzinski I Wspolnicy Sp.J.Torun, Poland, 87-100 Centrum Zdrowia MdmWarszawa, Poland, 00-635 Centrum Diagnostyczno-Lecznicze Barska Sp. Z O. O.Wloclawek, Poland, 87-800 Melita Medical Sp. Z O.O.Wroclaw, Poland, 50-449 Centrum Gastrologiczno HepatologiczneWroclaw, Poland, 50-555 LexmedicaWroclaw, Poland, 53-114 Russian Federation, Sestroretsk Spb Sbih \"City Hospital #40 Of The Kurortnyi Region\"Saint-Petersburg, Sestroretsk, Russian Federation, 197706 Russian Federation Llc \"Alliance Biomedical-Ural Group\"Izhevsk, Russian Federation, 426061 Clinic Of Fsbei He Ksmu Moh RfKrasnodar, Russian Federation, 350072 Llc \"Olla-Med\"Moscow, Russian Federation, 105554 Sechenov University On The Base Of Institute Of Translational Medicine And BiotechnologyMoscow, Russian Federation, 119435 Limited Liability Company \"Medical Center Sibnovomed\"Novosibirsk, Russian Federation, 630005 Federal State Budgetary Scientific Institution \"Scientific Research Institute Of Physiology AndNovosibirsk, Russian Federation, 630117 Clinic At Fsbei He \"Omsk State Medical University\" Moh RfOmsk, Russian Federation, 644050 Llc \"New Clinic\"Pyatigorsk, Russian Federation, 357500 Limited Liability Company \"Riat\"Saint-Petersburg, Russian Federation, 195220 Saint-Petersburg State Budgetary Healthcare Institution \"City Hospital #26\"Saint-Petersburg, Russian Federation, 196247 Private Institution Educational Organization Of Higher EducationSamara, Russian Federation, 443011 Non-State Healthcare Institution 'Railway Clinical Hospital At Samara Station Of Open Joint StockSamara, Russian Federation, 443029 Saint-Petersburg State Budgetary Healthcare Institution \"City Clinical Hospital Of The RighteousSt. Petersburg, Russian Federation, 197706|Tychy, Silesia, Poland, 43-100|Riyadh, Saudi Arabia, 11472|Zemun, Beograd, Serbia, 11080|Beograd, Serbia, 11000 Klinicko Bolnicki Centar Zemun, Klinika Za Internu Medicinu,Zemun, Beograd, Serbia, 11080|Beograd, Srbija, Serbia, 11000 Klinicki Centar KragujevacKragujevac, Srbija, Serbia, 34000 Klinicki Centar NisNis, Srbija, Serbia, 18000 Opsta Bolnica SuboticaSubotica, Srbija, Serbia, 24000 Opsta Bolnica \"Djordje Joanovic\", Odeljenje Interno, Odsek GastroenterologijaZrenjanin, Srbija, Serbia, 23000|Banska Bystrica, Slovakia, 975 17 Breznianske Centrum Gastroenterologie S.R.O.Brezno, Slovakia, 97701 Km Management Spol. S.R.O.Nitra, Slovakia, 949 01 Accout Center S.R.O. Gastroenterologicka AmbulanciaSahy, Slovakia, 936 01 Endomed, S.R.O.Vranov Nad Toplou, Slovakia, 093 01|Lenasia, Gauteng, South Africa, 1827 Wits Clinical Research Trial SiteParktown, Gauteng, South Africa, 2193 Wits Clinical Reasearch - Wits Bara Clinical Trial SiteSoweto, Gauteng, South Africa, 2013|Claremont, Western Cape, South Africa, 7708|Santander, Cantabria, Spain, 39008|Madrid, Spain, 28034 Hospital Universitario Virgen Del RocioSevilla, Spain, 41013 Hospital Universitari I Politecnic La FeValencia, Spain, 46026|Bern, Switzerland, Ch - 3012 UniversitÃ¤tsspital ZÃ¼richZÃ¼rich, Switzerland, Ch-8091|Tunis, Tunisia, 1007 Habib Thameur HospitalTunis, Tunisia, 1008|Ankara, Turkey, 06100 Ankara Universitesi Tip Fakultesi, Ibn-I Sina HastanesiAnkara, Turkey, 06100 Hacettepe Universitesi Tip FakultesiAnkara, Turkey, 06230 Bezmialem Vakif Universitesi Tip Fakultesi HastanesiIstanbul, Turkey, 34093 Istanbul Universitesi Cerrahpasa Tip FacultesiIstanbul, Turkey, 34098 Istanbul Universitesi Cerrahpasa Tip FakultesiIstanbul, Turkey, 34098 Erciyes Universitesi Tip FakultesiKayseri, Turkey, 38039 Kocaeli Universitesi Tip FakultesiKocaeli, Turkey, 41380 Mersin Universitesi Tip Fakultesi Hastanesi, Ic HastaliklariMersin, Turkey, 33110 Mersin Universitesi Tip Fakultesi HastanesiMersin, Turkey, 33110 Karadeniz Teknik Universitesi Tip Fakultesi, Ic HastaliklariTrabzon, Turkey, 61080 Karadeniz Teknik Universitesi Tip FakultesiTrabzon, Turkey, 61080 Bulent Ecevit Universitesi Tip FakultesiZonguldak, Turkey, 67600|Chernivtsi, Ukraine, 58001 Regional Municipal Institution \"Chernivtsi Regional Clinical Hospital\", Surgery DepartmentChernivtsi, Ukraine, 58001 Traumatology And Orthopedic Center LlcChernivtsi, Ukraine, 58023 Municipal Healthcare Institution Kharkiv City Clinical Hospital #2 N.A. Prof. O.O. ShalimovKharkiv, Ukraine, 61037 Private Enterprise Of Private Manufacturing Company \"Acinus\", Medical And Diagnostic CenterKropyvnytskyi, Ukraine, 25006 Kyiv Municipal Clinical Hospital #18, Proctology DepartmentKyiv, Ukraine, 01030 Medical Center \"Universal Clinic Oberig\" Of \"Kapital\" Llc, Gastro CenterKyiv, Ukraine, 03680 Lviv Clinical Hospital On Railway Transport Of Health Care Center Branch Of Pjsc Ukrainian RailwayLviv, Ukraine, 79007 Vinnytsia City Clinical Hospital No.1Vinnytsia, Ukraine, 21000 Private Small-Scale Enterprise Medical Center \"Pulse\"Vinnytsia, Ukraine, 21001 Vinnytsia Regional Clinical Hospital For War VeteransVinnytsia, Ukraine, 21005 Vinnytsia Regional Clinical Hospital N.A. M.I.PyrohovVinnytsia, Ukraine, 21018|Dubai, United Arab Emirates, 22241 Emirates Specialty HospitalDubai, United Arab Emirates, Po Box 505240|Dothan, Alabama, United States, 36301 Gut P.C., Dba Digestive Health Specialists Of The SoutheastDothan, Alabama, United States, 36305|Beverly Hills, California, United States, 90210 Long Beach Clinical Trial Services, Inc.Long Beach, California, United States, 90806 Entertainment Medical GroupLos Angeles, California, United States, 90036 Gastrointestinal Biosciences Clinical Trials, LlcLos Angeles, California, United States, 90067 Alliance Clinical Research, LlcPoway, California, United States, 92064|Colorado Springs, Colorado, United States, 80903|Clearwater, Florida, United States, 33756-3839 West Coast Endoscopy CenterClearwater, Florida, United States, 33756 Gastro FloridaClearwater, Florida, United States, 33762 University Of Miami Clinical Research BuildingMiami, Florida, United States, 33136 University Of Miami Crohn'S And Colitis CenterMiami, Florida, United States, 33136 University Of Miami Hospital And ClinicsMiami, Florida, United States, 33136 University Of Miami HospitalMiami, Florida, United States, 33136 Millenia Surgery CenterOrlando, Florida, United States, 32811 Hmd Research LlcOrlando, Florida, United States, 32819|Shawnee Mission, Kansas, United States, 66217|Houma, Louisiana, United States, 70360 Gulf Coast Surgical CenterHouma, Louisiana, United States, 70360 The Hearing Center (Audiology)Houma, Louisiana, United States, 70360|Chevy Chase, Maryland, United States, 20815 Mgg Group Co., Inc., Chevy Chase Clinical ResearchChevy Chase, Maryland, United States, 20815 Capitol ResearchRockville, Maryland, United States, 20850|Boston, Massachusetts, United States, 02115 Mass Eye And Ear, LongwoodBoston, Massachusetts, United States, 02115 Brigham And Women'S HospitalBoston, Massachusetts, United States, 02215 Brigham And Women'S HospitalChestnut Hill, Massachusetts, United States, 02467 Umass Memorial Medical CenterWorcester, Massachusetts, United States, 01655 University Of Massachusetts Medical SchoolWorcester, Massachusetts, United States, 01655|Caro, Michigan, United States, 48723 Clinical Research Institute Of Michigan, LlcChesterfield, Michigan, United States, 48047 Eastside Endoscopy CenterMacomb, Michigan, United States, 48044 Eastside Endoscopy CenterSaint Clair Shores, Michigan, United States, 48081|New York, New York, United States, 10021 New York Presbyterian Hospital - Weill Cornell Medical College (Colonoscopy)New York, New York, United States, 10065 New York Presbyterian Hospital - Weill Cornell Medical College Investigational PharmacyNew York, New York, United States, 10065 Weill Cornell Medical College - New York Presbyterian Hospital (Endoscopy Suite)New York, New York, United States, 10065 Weill Cornell Medical College - New York Presbyterian HospitalNew York, New York, United States, 10065 Digiovanna Institute For Medical Education And ResearchNorth Massapequa, New York, United States, 11758-1853|Chapel Hill, North Carolina, United States, 27514 Unc Hospitals Endoscopy Center At MeadowmontChapel Hill, North Carolina, United States, 27517 University Of North Carolina At Chapel HillChapel Hill, North Carolina, United States, 27599 Gastroenterology Associates Of The Piedmont, PaWinston-Salem, North Carolina, United States, 27103 Pmg Research Of Winston-Salem, LlcWinston-Salem, North Carolina, United States, 27103|Kingsport, Tennessee, United States, 37660 Holston Valley Surgery CenterKingsport, Tennessee, United States, 37660 Vanderbilt University Medical CenterNashville, Tennessee, United States, 37212-1375 Vanderbilt University Medical CenterNashville, Tennessee, United States, 37212-1610 Vanderbilt University Medical Center - Gi Endoscopy LabNashville, Tennessee, United States, 37232-5543 Vanderbilt University Medical CenterNashville, Tennessee, United States, 37232-7610 Vanderbilt University Medical Center - Gi Research RegulatoryNashville, Tennessee, United States, 37232|Arlington, Texas, United States, 76012 Envision Imaging (Cxr)Arlington, Texas, United States, 76012 Texas Clinical Research Institiute, LlcArlington, Texas, United States, 76012 Hrmd ResearchDallas, Texas, United States, 75240 Hermann Drive Surgical HospitalHouston, Texas, United States, 77004 Pearland Surgery CenterHouston, Texas, United States, 77047 Gulf Coast Research Group, LlcHouston, Texas, United States, 77098 Lonestar Endoscopy, LlpSouthlake, Texas, United States, 76092 Texas Digestive Disease ConsultantsSouthlake, Texas, United States, 76092|Fairfax, Virginia, United States, 22031","Alabama|California|Colorado|Florida|Kansas|Louisiana|Maryland|Massachusetts|Michigan|New York|North Carolina|Tennessee|Texas|Virginia","Australia|Austria|Belgium|Bosnia And Herzegovina|Canada|Croatia|Czechia|France|Georgia|Germany|Hungary|Italy|Lebanon|Poland|Saudi Arabia|Serbia|Slovakia|South Africa|Spain|Switzerland|Tunisia|Turkey|Ukraine|United Arab Emirates|United States","New South Wales Concord Repatriation General Hospital|Queensland Mater Misericordiae Ltd|Saint John Of God Health Care Inc.|Victoria Ballarat Base Hospital|Akh Wien Universitaetsklinik Fuer Innere Medizin Iii|University Hospital Brussels|Javna Zdravstvena Ustanova Univerzitetski Klinicki Centar Republike Srpske,|Manitoba Winnipeg Regional Health Authority - Health Sciences Centre, Winnipeg|Ontario HÃ´pital Montfort|Hrvatska Klinicki Bolnicki Centar Sestre Milosrdnice|Klinicki Bolnicki Centar Rijeka, Odjel Za Gastroenterologiju|Lekarna Altea|Hospital|The First University Clinic Of Tsmu|Paian Med Research Gmbh|Bekes Megyei Kozponti Korhaz, Rethy Pal Tagkorhaz|A.O.U. Policlinico G. Martino|Bari Irccs Saverio De Bellis|Bs A.O.Spedali Civili|Cz Univ. \"Magna Graecia\" Di Catanzaro|Mb Asst Monza|Milan Istituto Clinico Humanitas Irccs - Ibd Center|Milano Asst Rhodense - Ospedale Di Circolo Di Rho|Saint George Hospital University Medical Center|Niepubliczny Zaklad Opieki Zdrowotnej All-Medicus|Silesia H-T. Centrum Medyczne-Endoterapia|King Khalid University Hospital|Beograd Klinicko Bolnicki Centar \"Bezanijska Kosa\"|Klinicko Bolnicki Centar Zvezdara, Klinika Za Interne Bolesti,|Srbija Klinicki Centar Srbije, Klinika Za Gastroenterohepatologiju|Fakultna Nemocnica S Poliklinikou F.D. Roosevelta Banska Bystrica|, Gauteng Lenasia Clinical Trial Centre|, Western Cape Dr Wright Private Practice|Cantabria Hospital Universitario Marques De Valdecilla|Hospital Universitario Ramon Y Cajal|Verein Ibd Study Group|La Rabta Hospital|Ankara Universitesi Tip Fakultesi, Ibn-I Sina Hastanesi, Ic Hastaliklari Anabilim Dali,|Regional Municipal Institution \"Chernivtsi Regional Clinical Hospital\", Gastroenterology Department,|Al Baraha Hospital - Moh|Dothan Surgery Center|Brighton Surgical Center|Front Range Endoscopy Center|Gastro Florida|Westglen Gastrointestinal Consultants, P.A.|Cronola, Llc|Chevy Chase Endoscopy Center|Brigham And Women's Hospital|Caro Health Plaza|Weill Cornell Medical College (Clinical Site)|Unc Hospitals|Holston Medical Group|Cross Timbers Surgery Center L.P. (Colonoscopy)|Verity Research, Inc.",{"$nulls":3},"Pfizer CT.gov Call Center","2019-07-12","2020-05-25T16:36:05.588","2020-05-26T17:10:42.972","NCT03395184"]
["5ecbf3f5307e3d1b1f8d9c9d","NCT03395184","2019-08-29","Pfizer","PFE","Recruiting","Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PFâ€‘06700841 In Subjects With Moderate To Severe Crohn's Disease","Brepocitinib|Pf-06651600","JAK1 Inhibitor|TYK2 Inhibitor|JAK1 Inhibitor|JAK3 Inhibitor","Yes","['Brepocitinib', 'Pf-06651600']","Yes","['TYK2 Inhibitor', 'JAK3 Inhibitor']","Phase 2",2,250,"Anticipated","2018-02-02","2022-11-30","DAS","Disease Activity Score",{"$nulls":3},"The objectives of this study are to evaluate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-06651600 (200 mg for 8 weeks followed by 50 mg for 4 weeks) dosed once daily and PF-06700841 (60 mg for 12 weeks) dosed once daily during an induction period of 12 weeks, followed by an open label extension period at doses of 50 mg and 30 mg of PF 06651600 and PF 06700841, respectively, for 52 weeks.",null,"A PHASE 2A, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ORAL PF-06651600 AND PF-06700841 AS INDUCTION AND OPEN LABEL EXTENSION TREATMENT IN SUBJECTS WITH MODERATE TO SEVERE CROHN'S DISEASE","B7981007","Crohn's Disease","Crohn Disease","Gastrointestinal Diseases","Gastrointestinal","Experimental","PF-06700841 or placebo|PF-06651600 or placebo",null,"Drug","Placebo PF-06700841|PF-06700841|Placebo PF-06651600|PF-06651600","12 weeks, followed by PF-06700841, 30 mg QD for 52 weeks.|60 mg QD for 12 weeks followed by 30 mg QD for up to 52 weeks|12 weeks, followed by PF-06651600, 50 mg QD for 52 weeks|200 mg QD for 8 weeks, followed by 50 mg QD up to 56 weeks",null,"PF-06700841 or placebo|PF-06651600 or placebo","\n\n 1. Male and/or female subjects 18 years to 75 years of age\n 2. Documented diagnosis of ileal, ileocolonic, or colonic CD with a minimum disease duration of 3 months, as determined by endoscopic and histopathology assessment.\n 3. Endoscopic confirmation of active disease with total SES CD total score of at least 7. For isolated ileal disease, SES CD total score should be at least 4.\n 4. An average daily liquid/soft stool frequency (SF) greater than or equal to 2.5 or daily abdominal pain (AP) greater than or equal to 2.0.\n 5. Must have inadequate response to, loss of response to, or intolerance to at least one conventional therapy for CD:â€¢Steroids; Immunosuppressants (azathioprine [AZA], 6 MP, or methotrexate [MTX]); Anti TNF inhibitors (infliximab, adalimumab,certolizumab); Anti integrin inhibitors (eg, vedolizumab); Anti IL 12/23 inhibitor (ustekinumab).\n    \n    \n 6. Subjects currently receiving the following treatment for CD are eligible providing they have been on stable doses as described below: * Oral corticosteroids (prednisone or equivalent up to 25 mg/day; budesonide up to 9 mg/day). Stable dose for at least 2 weeks prior to baseline. If oral corticosteroids have been recently discontinued, they must have been stopped at least 2 weeks prior to baseline. Decreases in steroid use due to AEs are allowed.\n     * Oral 5 ASA or sulfasalazine are allowed providing that the dose is stable for at least 4 weeks prior to baseline.\n     * Crohn's disease related antibiotics are allowed providing that the dose is stable for at least 4 weeks prior to baseline. If antibiotics are stopped prior to baseline, they must be discontinued at least 4 days prior to baseline.\n    \n    \n\n","\n\n 1.  Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, diverticular disease, ulcerative colitis (UC), or clinical findings suggestive of UC.\n 2.  Presence of active (draining) fistulae or intra abdominal or perineal abscesses.\n 3.  Strictures with obstructive symptoms.\n 4.  Short bowel syndrome.\n 5.  History of bowel perforation requiring surgical intervention within the past 12 months.\n 6.  Previous bowel surgery resulting in an existing stoma. Subjects who have a j pouch are excluded, as a j pouch can result in a stoma.\n 7.  History of bowel surgery within 6 months prior to baseline.\n 8.  Subjects displaying clinical signs of fulminant colitis or toxic megacolon.\n 9.  Subjects with primary sclerosing cholangitis.\n 10. Subjects with evidence of colonic adenomas, dysplasia or neoplasia.\n 11. Abnormal findings on the chest x ray film such as presence of tuberculosis (TB), general infections, heart failure, or malignancy.\n 12. Any history of either untreated or inadequately treated latent or active TB infection, current treatment for active or latent TB infection or evidence of currently active TB by chest x ray, residing with or frequent close contact with individual(s) with active TB.\n 13. Subjects receiving the following therapies within the time period described below or expected to receive any of these therapies during the study period: 1.  >9 mg/day of oral budesonide or >25 mg/day of prednisone or equivalent oral systemic corticosteroid dose within 2 weeks prior to baseline.\n      2.  IV, IM (parenteral), or topical (rectal) treatment of 5 ASA or corticosteroid enemas/suppositories within 2 weeks prior to baseline.\n      3.  Azathioprine, 6 mercaptopurine, or methotrexate within 2 weeks prior to baseline.\n      4.  Anti TNF inhibitors (or biosimilars thereof) as described below: * Infliximab within 8 weeks prior to baseline;\n           * Adalimumab within 8 weeks prior to baseline;\n           * Certolizumab within 8 weeks prior to baseline;\n          \n          \n      5.  Anti integrin inhibitors (eg, vedolizumab) within 8 weeks prior to baseline.\n      6.  Ustekinumab within 8 weeks prior to baseline.\n      7.  Interferon therapy within 8 weeks prior to baseline.\n      8.  Subjects with prior treatment with lymphocyte depleting agents/therapies within 1 year prior to baseline (eg, CamPath[alemtuzumab], alkylating agents [eg, cyclophosphamide or chlorambucil], total lymphoid irradiation, etc).\n      9.  Subjects who have received rituximab or other selective B lymphocyte depleting agents within 1 year prior to baseline.\n      10. Subjects previously receiving leukocyte apheresis, including selective lymphocyte, monocyte, or granulocyte apheresis, or plasma exchange within 6 months prior to baseline.\n      11. Other marketed immunosuppressants or biologics with immunomodulatory properties within 3 months prior to baseline.\n      12. Subjects who have received other JAK inhibitors within 3 months prior to baseline.\n      13. Subjects who have not responded to or have been intolerant of other JAK inhibitors.\n      14. Other investigational procedures(s) or product(s), such as immunosuppressants used in transplantation (eg, mycophenolate mofetil, cyclosporine, rapamycin, or tacrolimus) or live (attenuated) vaccine within 30 days prior to baseline.","TNF","tumor necrosis factor","Protein","Lung, Breast, Ovary","Actual","2018-01-10","Actual","Anticipated","2022-11-30","Anticipated","2019-08-01","2017-12-05","2018-01-03","2019-08-27","Yes",null,"Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years","75 Years","All",null,"No","Yes\nPfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",null,"URL: https://pmiform.com/clinical-trial-info-request?StudyID=B7981007 [https://pmiform.com/clinical-trial-info-request?StudyID=B7981007] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To obtain contact information for a study center near you, click here.",null,"Yes","No",{"$nulls":17},"2017-003359-43|PIZZICATO","EudraCT Number|Alias Study Number","Proportion of subjects achieving clinically meaningful endoscopic improvement (reduction of more than or equal to 3 points from baseline in Simplified Endoscopic Activity Score for Crohn's Disease (SES-CD) at Week 12","12 weeks",null,"Number of participants with potentially clinically important serious infections findings|Mean change from baseline in SES-CD score at Week 12.|Proportion of subjects achieving SES-CD 25 and SES-CD 50 at Week 12.|Proportion of subjects achieving endoscopic remission (SES-CD less than or equal to 2) at Week 12.|Proportion of subjects achieving mucosal healing at Week 12.|Number of subjects with adverse events|Number of subjects with serious adverse events|Number of subjects with electrocardiogram findings of potential clinical importance.|Number of subjects withdrawal due to adverse events|Number of subjects with vital signs findings of potential clinical importance.|Number of subjects with laboratory tests findings of potential clinical importance.|Proportion of subjects achieving SES CD 25 and SES CD 50 at Week 64 among subjects who achieved SES CD 25 and SES CD 50 at week 12 respectively.|Proportion of subjects achieving clinically meaningful endoscopic improvement (CMEI response) at week 64 among subjects who achieved CMEI response at Week 12.","64 weeks|Baseline, week 12|Number of subjects achieving SES-CD 25 and SES-CD 50 at Week 12.|Number of subjects achieving endoscopic remission (SES-CD less than or equal to 2) at Week 12.|Number of subjects achieving mucosal healing at Week 12.|Number of participants with reported adverse events|Number of participants with reported serious adverse events|Number of participants with potentially clinically important electrocardiogram findings.|Number of subjects withdrawal due to adverse events.|Number of participants with potentially clinically important vital signs findings.|Number of participants with potentially clinically important laboratory findings.|Number of subjects achieving SES-CD 25 and SES-CD 50 at Week 64 among subjects who achieved SES CD 25 and SES CD 50 at week 12|Number of subject achieving clinically meaningful endoscopic improvement (CMEI response) at week 64 among subjects who achieved CMEI response at week 12.","Baseline, week 12|Week 12|Baseline up to 64 weeks|Baseline u to 64 weeks|week 64","ClinicalTrials.gov_Inquiries@pfizer.com","Pfizer CT.gov Call Center","1-800-718-1021","Concord, New South Wales, Australia, 2139|South Brisbane, Queensland, Australia, 4101|Subiaco, Western|Ballarat, Victoria, Australia, 3350|Wien, Austria, 1090|Jette, Belgium, 1090 University Hospitals LeuvenLeuven, Belgium, 3000 Chc - Saint-JosephLiÃ¨ge, Belgium, 4000|Banja Luka, Bosnia And Herzegovina, 78000 Sveucilisna Klinicka Bolnica Mostar,Mostar, Bosnia And Herzegovina, 88000|Winnipeg, Manitoba, Canada, R3A 1R9|Ottawa, Ontario, Canada, K1K 0T2|Zagreb, Hrvatska, Croatia, 10000|Rijeka, Croatia, 51000 Klinicki Bolnicki Centar Split, Zavod Za GastroenterologijuSplit, Croatia, 21000 Opca Bolnica Zadar, Odjel Za GastroenterologijuZadar, Croatia, 23000 Klinicka Bolnica Dubrava ZagrebZagreb, Croatia, 10000 Klinicki Bolnicki Centar Zagreb, Zavod Za Gastroenterologiju I HepatologijuZagreb, Croatia, 10000|Bilina, Czechia, 41801 Nemocnice Horovice, A.S.Horovice, Czechia, 268 31 Hepato-Gastroenterologie Hk S.R.O.Hradec Kralove, Czechia, 500 12 Medialpharma S.R.O.Hradec Kralove, Czechia, 500 12 Gastroenterologicka Ambulance A EndoskopieMost, Czechia, 43401 Vseobecna Fakultni NemocnicePraha 2, Czechia, 128 08 VÅ¡eobecnÃ¡ FakultnÃ­ Nemocnice V PrazePraha 2, Czechia, 128 08 Lekarna Sv. AnnaPraha 3, Czechia, 130 00 Egk S.R.O. - Sanatorium Sv. AnnyPraha 3, Czechia, 13000 Fakultni Nemocnice V MotolePraha 5, Czechia, 150 06 FakultnÃ­ Nemocnice V MotolePraha 5, Czechia, 150 06 Nemocnice Strakonice, A.S., Interni OddeleniStrakonice, Czechia, 386 01 Nemocnice Strakonice, A.S.Strakonice, Czechia, 386 29|Achrafieh, Beirut, Lebanon|Tbilisi, Georgia, 0141 David Tatishvili Medical CenterTbilisi, Georgia, 0186|Berlin, Germany, 10318 Krankenhaus Waldfriede E.V.,Berlin, Germany, 14163 Universitaetsklinikum BonnBonn, Germany, 53127 Universitaetsklinikum Schleswig-HolsteinKiel, Germany, 24105 UniversitÃ¤tsklinikum Giessen Und Marburg GmbhMarburg, Germany, 35043|Bekescsaba, Hungary, 5600 Semmelweis Egyetem, Ii. Belgyogyaszati KlinikaBudapest, Hungary, 1088 Szent Janos Korhaz Es Eszak-Budai Egyesitett Korhazak[Active, Not Recruiting]Budapest, Hungary, 1125 Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz, Endoszkopos LaboratoriumGyula, Hungary, 5700 Clinfan Szolgaltato Kft.Szekszard, Hungary, 7100 Csolnoky Ferenc Korhaz Belgyogyaszati Centrum I. Belgyogyaszati OsztalyVeszprem, Hungary, 8200|Messina, Italy, 98125 Aou Policlinico Di ModenaModena, Italy, 41124 Azienda Ospedaliera Di PadovaPadova, Italy, 35128 Policlinico Universitario Campus Bio-MedicoRoma, Italy, 00128 Policlinico Gemelli/Complesso Integrato ColumbusRome, Italy, 00168 Korea, Republic Of, Korea Kyungpook National University HospitalDaegu, Korea, Korea, Republic Of, 41944 Korea, Republic Of Kyung Hee University HospitalSeoul, Korea, Republic Of, 02447 Kangbuk Samsung HospitalSeoul, Korea, Republic Of, 03181 Severance Hospital, Yonsei University Health SystemSeoul, Korea, Republic Of, 03722 The Catholic University Of Korea, Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591|Castellana Grotte, Bari, Italy, 70013|Brescia, Bs, Italy, 25123|Catanzaro, Cz, Italy, 88100|Monza, Mb, Italy, 20090|Rozzano, Milan, Italy, 20089|Rho, Milano, Italy, 20017|Achrafieh, Lebanon American University Of Beirut Medical CenterBeirut, Lebanon Ain Wazein Medical VillageEl Chouf, Lebanon Centre Hospitalier Universitaire Notre Dame De SecoursJbeil, Lebanon Hammoud Hospital University Medical CenterSaida, Lebanon|Katowice, Poland, 40-659 Etg KielceKielce, Poland, 25-355 Indywidualna Specjalistyczna Praktyka Lekarska Maciej ZymlaKnurow, Poland, 44-190 Szpital W Knurowie Sp. Z O.O.Knurow, Poland, 44-190 Centrum Badan Klinicznych JciKrakow, Poland, 30-348 Marta Dagmara Banach Marta Banach Specjalistyczny Gabinet NeurologicznyKrakow, Poland, 30-539 Centrum Medyczne EvitaKrakow, Poland, 31-153 Szpital Specjalistyczny Im. Ludwika Rydygiera W Krakowie Sp. Z O.O.Krakow, Poland, 31-826 Centrum Medyczne Szpital Swietej Rodziny Sp Z O.O.Lodz, Poland, 90-302 Pracownia Endoskopii Centrum Medyczne Szpital Swietej Rodziny Sp Z O.O.Lodz, Poland, 90-302 Medical Magnus ClinicLodz, Poland, 90-552 Wojewodzki Szpital Specjalistyczny Im. Bieganskiego W LodziLodz, Poland, 91-347 Gastromed Sp. Z O.O.Lublin, Poland, 20-582 Ai Centrum Medyczne Sp. Z O.O. Sp.K.Poznan, Poland, 61-113 Korczowski Bartosz Gabinet LekarskiRzeszow, Poland, 35-302 Endoskopia Sp. Z O. O.Sopot, Poland, 81-756 Szpital Sredzki Serca Jezusowego Sp. Z O.O.Sroda Wielkopolska, Poland, 63-000 Ez-Med Sp. Z O.O. Sp.K.Swidnica, Poland, 58-100 Pracownia Endoskopii Szpital MswSzczecin, Poland, 70-001 Twoja Przychodnia Szczecinskie Centrum MedyczneSzczecin, Poland, 71-434 Gastromed Kopon, Zmudzinski I Wspolnicy Sp.J.Torun, Poland, 87-100 Centrum Zdrowia MdmWarszawa, Poland, 00-635 Centrum Diagnostyczno-Lecznicze Barska Sp. Z O. O.Wloclawek, Poland, 87-800 Melita Medical Sp. Z O.O.Wroclaw, Poland, 50-449 Centrum Gastrologiczno HepatologiczneWroclaw, Poland, 50-555 Planetmed Sp. Z.O.O.Wroclaw, Poland, 52-210 LexmedicaWroclaw, Poland, 53-114 Russian Federation, Sestroretsk Spb Sbih \"City Hospital #40 Of The Kurortnyi Region\"Saint-Petersburg, Sestroretsk, Russian Federation, 197706 Russian Federation Llc \"Alliance Biomedical-Ural Group\"Izhevsk, Russian Federation, 426061 Clinic Of Fsbei He Ksmu Moh RfKrasnodar, Russian Federation, 350072 Llc \"Olla-Med\"Moscow, Russian Federation, 105554 Sechenov University On The Base Of Institute Of Translational Medicine And BiotechnologyMoscow, Russian Federation, 119435 Limited Liability Company \"Medical Center Sibnovomed\"Novosibirsk, Russian Federation, 630005 Federal State Budgetary Scientific Institution \"Scientific Research Institute Of Physiology AndNovosibirsk, Russian Federation, 630117 Clinic At Fsbei He \"Omsk State Medical University\" Moh RfOmsk, Russian Federation, 644050 Llc \"New Clinic\"Pyatigorsk, Russian Federation, 357500 Limited Liability Company \"Riat\"Saint-Petersburg, Russian Federation, 195220 Saint-Petersburg State Budgetary Healthcare Institution \"City Hospital #26\"Saint-Petersburg, Russian Federation, 196247 Private Institution Educational Organization Of Higher EducationSamara, Russian Federation, 443011 Non-State Healthcare Institution 'Railway Clinical Hospital At Samara Station Of Open Joint StockSamara, Russian Federation, 443029 Saint-Petersburg State Budgetary Healthcare Institution \"City Clinical Hospital Of The RighteousSt. Petersburg, Russian Federation, 197706|Tychy, Silesia, Poland, 43-100|Riyadh, Saudi Arabia, 11426 King Khalid University HospitalRiyadh, Saudi Arabia, 11472|Zemun, Beograd, Serbia, 11080|Beograd, Serbia, 11000 Klinicko Bolnicki Centar Zemun, Klinika Za Internu Medicinu,Zemun, Beograd, Serbia, 11080|Beograd, Srbija, Serbia, 11000 Klinicki Centar KragujevacKragujevac, Srbija, Serbia, 34000 Klinicki Centar NisNis, Srbija, Serbia, 18000 Opsta Bolnica SuboticaSubotica, Srbija, Serbia, 24000 Opsta Bolnica \"Djordje Joanovic\", Odeljenje Interno, Odsek GastroenterologijaZrenjanin, Srbija, Serbia, 23000|Banska Bystrica, Slovakia, 975 17 Breznianske Centrum Gastroenterologie S.R.O.Brezno, Slovakia, 97701 Km Management Spol. S.R.O.Nitra, Slovakia, 949 01 Accout Center S.R.O. Gastroenterologicka AmbulanciaSahy, Slovakia, 936 01 Endomed, S.R.O.Vranov Nad Toplou, Slovakia, 093 01|Lenasia, Gauteng, South Africa, 1827 Wits Clinical Research Trial SiteParktown, Gauteng, South Africa, 2193 Wits Clinical Reasearch - Wits Bara Clinical Trial SiteSoweto, Gauteng, South Africa, 2013|Claremont, Western Cape, South Africa, 7708|Santander, Cantabria, Spain, 39008|Madrid, Spain, 28034 Hospital Universitario Virgen Del RocioSevilla, Spain, 41013 Hospital Universitari I Politecnic La FeValencia, Spain, 46026|Bern, Switzerland, Ch - 3012 UniversitÃ¤tsspital ZÃ¼richZÃ¼rich, Switzerland, Ch-8091|Tunis, Tunisia, 1007 Habib Thameur HospitalTunis, Tunisia, 1008|Ankara, Turkey, 06100 Ankara Universitesi Tip Fakultesi, Ibn-I Sina HastanesiAnkara, Turkey, 06100 Hacettepe Universitesi Tip FakultesiAnkara, Turkey, 06230 Bezmialem Vakif Universitesi Tip Fakultesi HastanesiIstanbul, Turkey, 34093 Istanbul Universitesi Cerrahpasa Tip FacultesiIstanbul, Turkey, 34098 Istanbul Universitesi Cerrahpasa Tip FakultesiIstanbul, Turkey, 34098 Erciyes Universitesi Tip FakultesiKayseri, Turkey, 38039 Kocaeli Universitesi Tip FakultesiKocaeli, Turkey, 41380 Mersin Universitesi Tip Fakultesi Hastanesi, Ic HastaliklariMersin, Turkey, 33110 Mersin Universitesi Tip Fakultesi HastanesiMersin, Turkey, 33110 Karadeniz Teknik Universitesi Tip Fakultesi, Ic HastaliklariTrabzon, Turkey, 61080 Karadeniz Teknik Universitesi Tip FakultesiTrabzon, Turkey, 61080 Bulent Ecevit Universitesi Tip FakultesiZonguldak, Turkey, 67600|Chernivtsi, Ukraine, 58001 Regional Municipal Institution \"Chernivtsi Regional Clinical Hospital\", Surgery DepartmentChernivtsi, Ukraine, 58001 Municipal Healthcare Institution Kharkiv City Clinical Hospital #2 N.A. Prof. O.O. ShalimovKharkiv, Ukraine, 61037 Private Enterprise Of Private Manufacturing Company \"Acinus\", Medical And Diagnostic CenterKropyvnytskyi, Ukraine, 25006 Kyiv Municipal Clinical Hospital #18, Proctology DepartmentKyiv, Ukraine, 01030 Medical Center \"Universal Clinic Oberig\" Of \"Kapital\" Llc, Gastro CenterKyiv, Ukraine, 03680 Lviv Clinical Hospital On Railway Transport Of Health Care Center Branch Of Pjsc Ukrainian RailwayLviv, Ukraine, 79007 Vinnytsia City Clinical Hospital No.1Vinnytsia, Ukraine, 21000 Private Small-Scale Enterprise Medical Center \"Pulse\"Vinnytsia, Ukraine, 21001 Vinnytsia Regional Clinical Hospital For War VeteransVinnytsia, Ukraine, 21005 Vinnytsia Regional Clinical Hospital N.A. M.I.PyrohovVinnytsia, Ukraine, 21018|Dubai, United Arab Emirates, 22241 Emirates Specialty HospitalDubai, United Arab Emirates, Po Box 505240|Dothan, Alabama, United States, 36301 Gut P.C., Dba Digestive Health Specialists Of The SoutheastDothan, Alabama, United States, 36305|Beverly Hills, California, United States, 90210 Long Beach Clinical Trial Services, Inc.Long Beach, California, United States, 90806 Entertainment Medical GroupLos Angeles, California, United States, 90036 Gastrointestinal Biosciences Clinical Trials, LlcLos Angeles, California, United States, 90067 Alliance Clinical Research, LlcPoway, California, United States, 92064|Colorado Springs, Colorado, United States, 80903|Clearwater, Florida, United States, 33756-3839 West Coast Endoscopy CenterClearwater, Florida, United States, 33756 Gastro FloridaClearwater, Florida, United States, 33762 University Of Miami Clinical Research BuildingMiami, Florida, United States, 33136 University Of Miami Crohn'S And Colitis CenterMiami, Florida, United States, 33136 University Of Miami Hospital And ClinicsMiami, Florida, United States, 33136 University Of Miami HospitalMiami, Florida, United States, 33136 Millenia Surgery CenterOrlando, Florida, United States, 32811 Hmd Research LlcOrlando, Florida, United States, 32819|Shawnee Mission, Kansas, United States, 66217|Houma, Louisiana, United States, 70360 Gulf Coast Surgical CenterHouma, Louisiana, United States, 70360 The Hearing Center (Audiology)Houma, Louisiana, United States, 70360|Chevy Chase, Maryland, United States, 20815 Mgg Group Co., Inc., Chevy Chase Clinical ResearchChevy Chase, Maryland, United States, 20815 Capitol ResearchRockville, Maryland, United States, 20850|Boston, Massachusetts, United States, 02115 Mass Eye And Ear, LongwoodBoston, Massachusetts, United States, 02115 Brigham And Women'S HospitalBoston, Massachusetts, United States, 02215 Brigham And Women'S HospitalChestnut Hill, Massachusetts, United States, 02467 Umass Memorial Medical CenterWorcester, Massachusetts, United States, 01655 University Of Massachusetts Medical SchoolWorcester, Massachusetts, United States, 01655|Caro, Michigan, United States, 48723 Clinical Research Institute Of Michigan, LlcChesterfield, Michigan, United States, 48047 Eastside Endoscopy CenterMacomb, Michigan, United States, 48044 Eastside Endoscopy CenterSaint Clair Shores, Michigan, United States, 48081|New York, New York, United States, 10021 New York Presbyterian Hospital - Weill Cornell Medical College (Colonoscopy)New York, New York, United States, 10065 New York Presbyterian Hospital - Weill Cornell Medical College Investigational PharmacyNew York, New York, United States, 10065 Weill Cornell Medical College - New York Presbyterian Hospital (Endoscopy Suite)New York, New York, United States, 10065 Weill Cornell Medical College - New York Presbyterian HospitalNew York, New York, United States, 10065 Digiovanna Institute For Medical Education And ResearchNorth Massapequa, New York, United States, 11758-1853|Chapel Hill, North Carolina, United States, 27514 Unc Hospitals Endoscopy Center At MeadowmontChapel Hill, North Carolina, United States, 27517 University Of North Carolina At Chapel HillChapel Hill, North Carolina, United States, 27599 Gastroenterology Associates Of The Piedmont, PaWinston-Salem, North Carolina, United States, 27103 Pmg Research Of Winston-Salem, LlcWinston-Salem, North Carolina, United States, 27103|Kingsport, Tennessee, United States, 37660 Holston Valley Surgery CenterKingsport, Tennessee, United States, 37660 Vanderbilt University Medical CenterNashville, Tennessee, United States, 37212-1375 Vanderbilt University Medical CenterNashville, Tennessee, United States, 37212-1610 Vanderbilt University Medical Center - Gi Endoscopy LabNashville, Tennessee, United States, 37232-5543 Vanderbilt University Medical CenterNashville, Tennessee, United States, 37232-7610 Vanderbilt University Medical Center - Gi Research RegulatoryNashville, Tennessee, United States, 37232|Arlington, Texas, United States, 76012 Envision Imaging (Cxr)Arlington, Texas, United States, 76012 Texas Clinical Research Institiute, LlcArlington, Texas, United States, 76012 Hrmd ResearchDallas, Texas, United States, 75240 Hermann Drive Surgical HospitalHouston, Texas, United States, 77004 Pearland Surgery CenterHouston, Texas, United States, 77047 Gulf Coast Research Group, LlcHouston, Texas, United States, 77098 Lonestar Endoscopy, LlpSouthlake, Texas, United States, 76092 Texas Digestive Disease ConsultantsSouthlake, Texas, United States, 76092|Fairfax, Virginia, United States, 22031","Alabama|California|Colorado|Florida|Kansas|Louisiana|Maryland|Massachusetts|Michigan|New York|North Carolina|Tennessee|Texas|Virginia","Australia|Austria|Belgium|Bosnia And Herzegovina|Canada|Croatia|Czechia|France|Georgia|Germany|Hungary|Italy|Lebanon|Poland|Saudi Arabia|Serbia|Slovakia|South Africa|Spain|Switzerland|Tunisia|Turkey|Ukraine|United Arab Emirates|United States","New South Wales Concord Repatriation General Hospital|Queensland Mater Misericordiae Ltd|Saint John Of God Health Care Inc.|Victoria Ballarat Base Hospital|Akh Wien Universitaetsklinik Fuer Innere Medizin Iii|University Hospital Brussels|Javna Zdravstvena Ustanova Univerzitetski Klinicki Centar Republike Srpske,|Manitoba Winnipeg Regional Health Authority - Health Sciences Centre, Winnipeg|Ontario HÃ´pital Montfort|Hrvatska Klinicki Bolnicki Centar Sestre Milosrdnice|Klinicki Bolnicki Centar Rijeka, Odjel Za Gastroenterologiju|Lekarna Altea|Hospital|The First University Clinic Of Tsmu|Paian Med Research Gmbh|Bekes Megyei Kozponti Korhaz, Rethy Pal Tagkorhaz|A.O.U. Policlinico G. Martino|Bari Irccs Saverio De Bellis|Bs A.O.Spedali Civili|Cz Univ. \"Magna Graecia\" Di Catanzaro|Mb Asst Monza|Milan Istituto Clinico Humanitas Irccs - Ibd Center|Milano Asst Rhodense - Ospedale Di Circolo Di Rho|Saint George Hospital University Medical Center|Niepubliczny Zaklad Opieki Zdrowotnej All-Medicus|Silesia H-T. Centrum Medyczne-Endoterapia|King Abdulaziz Medical City|Beograd Klinicko Bolnicki Centar \"Bezanijska Kosa\"|Klinicko Bolnicki Centar Zvezdara, Klinika Za Interne Bolesti,|Srbija Klinicki Centar Srbije, Klinika Za Gastroenterohepatologiju|Fakultna Nemocnica S Poliklinikou F.D. Roosevelta Banska Bystrica|, Gauteng Lenasia Clinical Trial Centre|, Western Cape Dr Wright Private Practice|Cantabria Hospital Universitario Marques De Valdecilla|Hospital Universitario Ramon Y Cajal|Verein Ibd Study Group|La Rabta Hospital|Ankara Universitesi Tip Fakultesi, Ibn-I Sina Hastanesi, Ic Hastaliklari Anabilim Dali,|Regional Municipal Institution \"Chernivtsi Regional Clinical Hospital\", Gastroenterology Department,|Al Baraha Hospital - Moh|Dothan Surgery Center|Brighton Surgical Center|Front Range Endoscopy Center|Gastro Florida|Westglen Gastrointestinal Consultants, P.A.|Cronola, Llc|Chevy Chase Endoscopy Center|Brigham And Women's Hospital|Caro Health Plaza|Weill Cornell Medical College (Clinical Site)|Unc Hospitals|Holston Medical Group|Cross Timbers Surgery Center L.P. (Colonoscopy)|Verity Research, Inc.",{"$nulls":3},"Pfizer CT.gov Call Center","2019-08-27","2020-05-25T16:36:05.707","2020-05-26T17:10:42.972","NCT03395184"]
["5ecbf3f511702c1b1b916a1d","NCT03395184","2019-09-20","Pfizer","PFE","Recruiting","Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PFâ€‘06700841 In Subjects With Moderate To Severe Crohn's Disease","Brepocitinib|Pf-06651600","JAK1 Inhibitor|TYK2 Inhibitor|JAK1 Inhibitor|JAK3 Inhibitor","Yes","['Brepocitinib', 'Pf-06651600']","Yes","['TYK2 Inhibitor', 'JAK3 Inhibitor']","Phase 2",2,250,"Anticipated","2018-02-02","2022-11-30","DAS","Disease Activity Score",{"$nulls":3},"The objectives of this study are to evaluate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-06651600 (200 mg for 8 weeks followed by 50 mg for 4 weeks) dosed once daily and PF-06700841 (60 mg for 12 weeks) dosed once daily during an induction period of 12 weeks, followed by an open label extension period at doses of 50 mg and 30 mg of PF 06651600 and PF 06700841, respectively, for 52 weeks.",null,"A PHASE 2A, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ORAL PF-06651600 AND PF-06700841 AS INDUCTION AND OPEN LABEL EXTENSION TREATMENT IN SUBJECTS WITH MODERATE TO SEVERE CROHN'S DISEASE","B7981007","Crohn's Disease","Crohn Disease","Gastrointestinal Diseases","Gastrointestinal","Experimental","PF-06700841 or placebo|PF-06651600 or placebo",null,"Drug","Placebo PF-06700841|PF-06700841|Placebo PF-06651600|PF-06651600","12 weeks, followed by PF-06700841, 30 mg QD for 52 weeks.|60 mg QD for 12 weeks followed by 30 mg QD for up to 52 weeks|12 weeks, followed by PF-06651600, 50 mg QD for 52 weeks|200 mg QD for 8 weeks, followed by 50 mg QD up to 56 weeks",null,"PF-06700841 or placebo|PF-06651600 or placebo","\n\n 1. Male and/or female subjects 18 years to 75 years of age\n 2. Documented diagnosis of ileal, ileocolonic, or colonic CD with a minimum disease duration of 3 months, as determined by endoscopic and histopathology assessment.\n 3. Endoscopic confirmation of active disease with total SES CD total score of at least 7. For isolated ileal disease, SES CD total score should be at least 4.\n 4. An average daily liquid/soft stool frequency (SF) greater than or equal to 2.5 or daily abdominal pain (AP) greater than or equal to 2.0.\n 5. Must have inadequate response to, loss of response to, or intolerance to at least one conventional therapy for CD:â€¢Steroids; Immunosuppressants (azathioprine [AZA], 6 MP, or methotrexate [MTX]); Anti TNF inhibitors (infliximab, adalimumab,certolizumab); Anti integrin inhibitors (eg, vedolizumab); Anti IL 12/23 inhibitor (ustekinumab).\n    \n    \n 6. Subjects currently receiving the following treatment for CD are eligible providing they have been on stable doses as described below: * Oral corticosteroids (prednisone or equivalent up to 25 mg/day; budesonide up to 9 mg/day). Stable dose for at least 2 weeks prior to baseline. If oral corticosteroids have been recently discontinued, they must have been stopped at least 2 weeks prior to baseline. Decreases in steroid use due to AEs are allowed.\n     * Oral 5 ASA or sulfasalazine are allowed providing that the dose is stable for at least 4 weeks prior to baseline.\n     * Crohn's disease related antibiotics are allowed providing that the dose is stable for at least 4 weeks prior to baseline. If antibiotics are stopped prior to baseline, they must be discontinued at least 4 days prior to baseline.\n    \n    \n\n","\n\n 1.  Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, diverticular disease, ulcerative colitis (UC), or clinical findings suggestive of UC.\n 2.  Presence of active (draining) fistulae or intra abdominal or perineal abscesses.\n 3.  Strictures with obstructive symptoms.\n 4.  Short bowel syndrome.\n 5.  History of bowel perforation requiring surgical intervention within the past 12 months.\n 6.  Previous bowel surgery resulting in an existing stoma. Subjects who have a j pouch are excluded, as a j pouch can result in a stoma.\n 7.  History of bowel surgery within 6 months prior to baseline.\n 8.  Subjects displaying clinical signs of fulminant colitis or toxic megacolon.\n 9.  Subjects with primary sclerosing cholangitis.\n 10. Subjects with evidence of colonic adenomas, dysplasia or neoplasia.\n 11. Abnormal findings on the chest x ray film such as presence of tuberculosis (TB), general infections, heart failure, or malignancy.\n 12. Any history of either untreated or inadequately treated latent or active TB infection, current treatment for active or latent TB infection or evidence of currently active TB by chest x ray, residing with or frequent close contact with individual(s) with active TB.\n 13. Subjects receiving the following therapies within the time period described below or expected to receive any of these therapies during the study period: 1.  >9 mg/day of oral budesonide or >25 mg/day of prednisone or equivalent oral systemic corticosteroid dose within 2 weeks prior to baseline.\n      2.  IV, IM (parenteral), or topical (rectal) treatment of 5 ASA or corticosteroid enemas/suppositories within 2 weeks prior to baseline.\n      3.  Azathioprine, 6 mercaptopurine, or methotrexate within 2 weeks prior to baseline.\n      4.  Anti TNF inhibitors (or biosimilars thereof) as described below: * Infliximab within 8 weeks prior to baseline;\n           * Adalimumab within 8 weeks prior to baseline;\n           * Certolizumab within 8 weeks prior to baseline;\n          \n          \n      5.  Anti integrin inhibitors (eg, vedolizumab) within 8 weeks prior to baseline.\n      6.  Ustekinumab within 8 weeks prior to baseline.\n      7.  Interferon therapy within 8 weeks prior to baseline.\n      8.  Subjects with prior treatment with lymphocyte depleting agents/therapies within 1 year prior to baseline (eg, CamPath[alemtuzumab], alkylating agents [eg, cyclophosphamide or chlorambucil], total lymphoid irradiation, etc).\n      9.  Subjects who have received rituximab or other selective B lymphocyte depleting agents within 1 year prior to baseline.\n      10. Subjects previously receiving leukocyte apheresis, including selective lymphocyte, monocyte, or granulocyte apheresis, or plasma exchange within 6 months prior to baseline.\n      11. Other marketed immunosuppressants or biologics with immunomodulatory properties within 3 months prior to baseline.\n      12. Subjects who have received other JAK inhibitors within 3 months prior to baseline.\n      13. Subjects who have not responded to or have been intolerant of other JAK inhibitors.\n      14. Other investigational procedures(s) or product(s), such as immunosuppressants used in transplantation (eg, mycophenolate mofetil, cyclosporine, rapamycin, or tacrolimus) or live (attenuated) vaccine within 30 days prior to baseline.","TNF","tumor necrosis factor","Protein","Lung, Breast, Ovary","Actual","2018-01-10","Actual","Anticipated","2022-11-30","Anticipated","2019-09-01","2017-12-05","2018-01-03","2019-09-18","Yes",null,"Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years","75 Years","All",null,"No","Yes\nPfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",null,"URL: https://pmiform.com/clinical-trial-info-request?StudyID=B7981007 [https://pmiform.com/clinical-trial-info-request?StudyID=B7981007] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To obtain contact information for a study center near you, click here.",null,"Yes","No",{"$nulls":17},"2017-003359-43|PIZZICATO","EudraCT Number|Alias Study Number","Proportion of subjects achieving clinically meaningful endoscopic improvement (reduction of more than or equal to 3 points from baseline in Simplified Endoscopic Activity Score for Crohn's Disease (SES-CD) at Week 12","12 weeks",null,"Number of participants with potentially clinically important serious infections findings|Mean change from baseline in SES-CD score at Week 12.|Proportion of subjects achieving SES-CD 25 and SES-CD 50 at Week 12.|Proportion of subjects achieving endoscopic remission (SES-CD less than or equal to 2) at Week 12.|Proportion of subjects achieving mucosal healing at Week 12.|Number of subjects with adverse events|Number of subjects with serious adverse events|Number of subjects with electrocardiogram findings of potential clinical importance.|Number of subjects withdrawal due to adverse events|Number of subjects with vital signs findings of potential clinical importance.|Number of subjects with laboratory tests findings of potential clinical importance.|Proportion of subjects achieving SES CD 25 and SES CD 50 at Week 64 among subjects who achieved SES CD 25 and SES CD 50 at week 12 respectively.|Proportion of subjects achieving clinically meaningful endoscopic improvement (CMEI response) at week 64 among subjects who achieved CMEI response at Week 12.","64 weeks|Baseline, week 12|Number of subjects achieving SES-CD 25 and SES-CD 50 at Week 12.|Number of subjects achieving endoscopic remission (SES-CD less than or equal to 2) at Week 12.|Number of subjects achieving mucosal healing at Week 12.|Number of participants with reported adverse events|Number of participants with reported serious adverse events|Number of participants with potentially clinically important electrocardiogram findings.|Number of subjects withdrawal due to adverse events.|Number of participants with potentially clinically important vital signs findings.|Number of participants with potentially clinically important laboratory findings.|Number of subjects achieving SES-CD 25 and SES-CD 50 at Week 64 among subjects who achieved SES CD 25 and SES CD 50 at week 12|Number of subject achieving clinically meaningful endoscopic improvement (CMEI response) at week 64 among subjects who achieved CMEI response at week 12.","Baseline, week 12|Week 12|Baseline up to 64 weeks|Baseline u to 64 weeks|week 64","ClinicalTrials.gov_Inquiries@pfizer.com","Pfizer CT.gov Call Center","1-800-718-1021","Concord, New South Wales, Australia, 2139|South Brisbane, Queensland, Australia, 4101|Subiaco, Western|Ballarat, Victoria, Australia, 3350|Wien, Austria, 1090|Jette, Belgium, 1090 University Hospitals LeuvenLeuven, Belgium, 3000 Chc - Saint-JosephLiÃ¨ge, Belgium, 4000|Banja Luka, Bosnia And Herzegovina, 78000 Sveucilisna Klinicka Bolnica Mostar,Mostar, Bosnia And Herzegovina, 88000|Winnipeg, Manitoba, Canada, R3A 1R9|Ottawa, Ontario, Canada, K1K 0T2|Zagreb, Hrvatska, Croatia, 10000|Rijeka, Croatia, 51000 Klinicki Bolnicki Centar Split, Zavod Za GastroenterologijuSplit, Croatia, 21000 Opca Bolnica Zadar, Odjel Za GastroenterologijuZadar, Croatia, 23000 Klinicka Bolnica Dubrava ZagrebZagreb, Croatia, 10000 Klinicki Bolnicki Centar Zagreb, Zavod Za Gastroenterologiju I HepatologijuZagreb, Croatia, 10000|Bilina, Czechia, 41801 Nemocnice Horovice, A.S.Horovice, Czechia, 268 31 Hepato-Gastroenterologie Hk S.R.O.Hradec Kralove, Czechia, 500 12 Medialpharma S.R.O.Hradec Kralove, Czechia, 500 12 Gastroenterologicka Ambulance A EndoskopieMost, Czechia, 43401 Vseobecna Fakultni NemocnicePraha 2, Czechia, 128 08 VÅ¡eobecnÃ¡ FakultnÃ­ Nemocnice V PrazePraha 2, Czechia, 128 08 Lekarna Sv. AnnaPraha 3, Czechia, 130 00 Egk S.R.O. - Sanatorium Sv. AnnyPraha 3, Czechia, 13000 Fakultni Nemocnice V MotolePraha 5, Czechia, 150 06 FakultnÃ­ Nemocnice V MotolePraha 5, Czechia, 150 06 Nemocnice Strakonice, A.S., Interni OddeleniStrakonice, Czechia, 386 01 Nemocnice Strakonice, A.S.Strakonice, Czechia, 386 29|Achrafieh, Beirut, Lebanon|Tbilisi, Georgia, 0141 David Tatishvili Medical CenterTbilisi, Georgia, 0186|Berlin, Germany, 10318 Krankenhaus Waldfriede E.V.,Berlin, Germany, 14163 Universitaetsklinikum BonnBonn, Germany, 53127 Universitaetsklinikum Schleswig-HolsteinKiel, Germany, 24105 UniversitÃ¤tsklinikum Giessen Und Marburg GmbhMarburg, Germany, 35043|Bekescsaba, Hungary, 5600 Semmelweis Egyetem, Ii. Belgyogyaszati KlinikaBudapest, Hungary, 1088 Szent Janos Korhaz Es Eszak-Budai Egyesitett Korhazak[Active, Not Recruiting]Budapest, Hungary, 1125 Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz, Endoszkopos LaboratoriumGyula, Hungary, 5700 Clinfan Szolgaltato Kft.Szekszard, Hungary, 7100 Csolnoky Ferenc Korhaz Belgyogyaszati Centrum I. Belgyogyaszati OsztalyVeszprem, Hungary, 8200|Messina, Italy, 98125 Aou Policlinico Di ModenaModena, Italy, 41124 Azienda Ospedaliera Di PadovaPadova, Italy, 35128 Policlinico Universitario Campus Bio-MedicoRoma, Italy, 00128 Policlinico Gemelli/Complesso Integrato ColumbusRome, Italy, 00168 Korea, Republic Of, Korea Kyungpook National University HospitalDaegu, Korea, Korea, Republic Of, 41944 Korea, Republic Of Kyung Hee University HospitalSeoul, Korea, Republic Of, 02447 Kangbuk Samsung HospitalSeoul, Korea, Republic Of, 03181 Severance Hospital, Yonsei University Health SystemSeoul, Korea, Republic Of, 03722 The Catholic University Of Korea, Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591|Castellana Grotte, Bari, Italy, 70013|Brescia, Bs, Italy, 25123|Catanzaro, Cz, Italy, 88100|Monza, Mb, Italy, 20090|Rozzano, Milan, Italy, 20089|Rho, Milano, Italy, 20017|Achrafieh, Lebanon American University Of Beirut Medical CenterBeirut, Lebanon Ain Wazein Medical VillageEl Chouf, Lebanon Centre Hospitalier Universitaire Notre Dame De SecoursJbeil, Lebanon Hammoud Hospital University Medical CenterSaida, Lebanon|Katowice, Poland, 40-659 Etg KielceKielce, Poland, 25-355 Indywidualna Specjalistyczna Praktyka Lekarska Maciej ZymlaKnurow, Poland, 44-190 Szpital W Knurowie Sp. Z O.O.Knurow, Poland, 44-190 Centrum Badan Klinicznych JciKrakow, Poland, 30-348 Marta Dagmara Banach Marta Banach Specjalistyczny Gabinet NeurologicznyKrakow, Poland, 30-539 Centrum Medyczne EvitaKrakow, Poland, 31-153 Szpital Specjalistyczny Im. Ludwika Rydygiera W Krakowie Sp. Z O.O.Krakow, Poland, 31-826 Centrum Medyczne Szpital Swietej Rodziny Sp Z O.O.Lodz, Poland, 90-302 Pracownia Endoskopii Centrum Medyczne Szpital Swietej Rodziny Sp Z O.O.Lodz, Poland, 90-302 Medical Magnus ClinicLodz, Poland, 90-552 Wojewodzki Szpital Specjalistyczny Im. Bieganskiego W LodziLodz, Poland, 91-347 Gastromed Sp. Z O.O.Lublin, Poland, 20-582 Ai Centrum Medyczne Sp. Z O.O. Sp.K.Poznan, Poland, 61-113 Korczowski Bartosz Gabinet LekarskiRzeszow, Poland, 35-302 Endoskopia Sp. Z O. O.Sopot, Poland, 81-756 Szpital Sredzki Serca Jezusowego Sp. Z O.O.Sroda Wielkopolska, Poland, 63-000 Ez-Med Sp. Z O.O. Sp.K.Swidnica, Poland, 58-100 Pracownia Endoskopii Szpital MswSzczecin, Poland, 70-001 Twoja Przychodnia Szczecinskie Centrum MedyczneSzczecin, Poland, 71-434 Gastromed Kopon, Zmudzinski I Wspolnicy Sp.J.Torun, Poland, 87-100 Centrum Zdrowia MdmWarszawa, Poland, 00-635 Centrum Diagnostyczno-Lecznicze Barska Sp. Z O. O.Wloclawek, Poland, 87-800 Melita Medical Sp. Z O.O.Wroclaw, Poland, 50-449 Centrum Gastrologiczno HepatologiczneWroclaw, Poland, 50-555 Planetmed Sp. Z.O.O.Wroclaw, Poland, 52-210 LexmedicaWroclaw, Poland, 53-114 Russian Federation, Sestroretsk Spb Sbih \"City Hospital #40 Of The Kurortnyi Region\"Saint-Petersburg, Sestroretsk, Russian Federation, 197706 Russian Federation Llc \"Alliance Biomedical-Ural Group\"Izhevsk, Russian Federation, 426061 Clinic Of Fsbei He Ksmu Moh RfKrasnodar, Russian Federation, 350072 Llc \"Olla-Med\"Moscow, Russian Federation, 105554 Sechenov University On The Base Of Institute Of Translational Medicine And BiotechnologyMoscow, Russian Federation, 119435 Limited Liability Company \"Medical Center Sibnovomed\"Novosibirsk, Russian Federation, 630005 Federal State Budgetary Scientific Institution \"Scientific Research Institute Of Physiology AndNovosibirsk, Russian Federation, 630117 Clinic At Fsbei He \"Omsk State Medical University\" Moh RfOmsk, Russian Federation, 644050 Llc \"New Clinic\"Pyatigorsk, Russian Federation, 357500 Limited Liability Company \"Riat\"Saint-Petersburg, Russian Federation, 195220 Saint-Petersburg State Budgetary Healthcare Institution \"City Hospital #26\"Saint-Petersburg, Russian Federation, 196247 Private Institution Educational Organization Of Higher EducationSamara, Russian Federation, 443011 Non-State Healthcare Institution 'Railway Clinical Hospital At Samara Station Of Open Joint StockSamara, Russian Federation, 443029 Saint-Petersburg State Budgetary Healthcare Institution \"City Clinical Hospital Of The RighteousSt. Petersburg, Russian Federation, 197706|Tychy, Silesia, Poland, 43-100|Riyadh, Saudi Arabia, 11426 King Khalid University HospitalRiyadh, Saudi Arabia, 11472|Zemun, Beograd, Serbia, 11080|Beograd, Serbia, 11000 Klinicko Bolnicki Centar Zemun, Klinika Za Internu Medicinu,Zemun, Beograd, Serbia, 11080|Beograd, Srbija, Serbia, 11000 Klinicki Centar KragujevacKragujevac, Srbija, Serbia, 34000 Klinicki Centar NisNis, Srbija, Serbia, 18000 Opsta Bolnica SuboticaSubotica, Srbija, Serbia, 24000 Opsta Bolnica \"Djordje Joanovic\", Odeljenje Interno, Odsek GastroenterologijaZrenjanin, Srbija, Serbia, 23000|Banska Bystrica, Slovakia, 975 17 Breznianske Centrum Gastroenterologie S.R.O.Brezno, Slovakia, 97701 Km Management Spol. S.R.O.Nitra, Slovakia, 949 01 Accout Center S.R.O. Gastroenterologicka AmbulanciaSahy, Slovakia, 936 01 Endomed, S.R.O.Vranov Nad Toplou, Slovakia, 093 01|Lenasia, Gauteng, South Africa, 1827 Wits Clinical Research Trial SiteParktown, Gauteng, South Africa, 2193 Wits Clinical Reasearch - Wits Bara Clinical Trial SiteSoweto, Gauteng, South Africa, 2013|Claremont, Western Cape, South Africa, 7708|Santander, Cantabria, Spain, 39008|Madrid, Spain, 28034 Hospital Universitario Virgen Del RocioSevilla, Spain, 41013 Hospital Universitari I Politecnic La FeValencia, Spain, 46026|Bern, Switzerland, Ch - 3012 UniversitÃ¤tsspital ZÃ¼richZÃ¼rich, Switzerland, Ch-8091|Tunis, Tunisia, 1007 Habib Thameur HospitalTunis, Tunisia, 1008|Ankara, Turkey, 06100 Ankara Universitesi Tip Fakultesi, Ibn-I Sina HastanesiAnkara, Turkey, 06100 Hacettepe Universitesi Tip FakultesiAnkara, Turkey, 06230 Bezmialem Vakif Universitesi Tip Fakultesi HastanesiIstanbul, Turkey, 34093 Istanbul Universitesi Cerrahpasa Tip FacultesiIstanbul, Turkey, 34098 Istanbul Universitesi Cerrahpasa Tip FakultesiIstanbul, Turkey, 34098 Erciyes Universitesi Tip FakultesiKayseri, Turkey, 38039 Kocaeli Universitesi Tip FakultesiKocaeli, Turkey, 41380 Mersin Universitesi Tip Fakultesi Hastanesi, Ic HastaliklariMersin, Turkey, 33110 Mersin Universitesi Tip Fakultesi HastanesiMersin, Turkey, 33110 Karadeniz Teknik Universitesi Tip Fakultesi, Ic HastaliklariTrabzon, Turkey, 61080 Karadeniz Teknik Universitesi Tip FakultesiTrabzon, Turkey, 61080 Bulent Ecevit Universitesi Tip FakultesiZonguldak, Turkey, 67600|Chernivtsi, Ukraine, 58001 Regional Municipal Institution \"Chernivtsi Regional Clinical Hospital\", Surgery DepartmentChernivtsi, Ukraine, 58001 Municipal Healthcare Institution Kharkiv City Clinical Hospital #2 N.A. Prof. O.O. ShalimovKharkiv, Ukraine, 61037 Private Enterprise Of Private Manufacturing Company \"Acinus\", Medical And Diagnostic CenterKropyvnytskyi, Ukraine, 25006 Kyiv Municipal Clinical Hospital #18, Proctology DepartmentKyiv, Ukraine, 01030 Medical Center \"Universal Clinic Oberig\" Of \"Kapital\" Llc, Gastro CenterKyiv, Ukraine, 03680 Lviv Clinical Hospital On Railway Transport Of Health Care Center Branch Of Pjsc Ukrainian RailwayLviv, Ukraine, 79007 Vinnytsia City Clinical Hospital No.1Vinnytsia, Ukraine, 21000 Private Small-Scale Enterprise Medical Center \"Pulse\"Vinnytsia, Ukraine, 21001 Vinnytsia Regional Clinical Hospital For War VeteransVinnytsia, Ukraine, 21005 Vinnytsia Regional Clinical Hospital N.A. M.I.PyrohovVinnytsia, Ukraine, 21018|Dubai, United Arab Emirates, 22241 Emirates Specialty HospitalDubai, United Arab Emirates, Po Box 505240|Dothan, Alabama, United States, 36301 Gut P.C., Dba Digestive Health Specialists Of The SoutheastDothan, Alabama, United States, 36305|Beverly Hills, California, United States, 90210 Long Beach Clinical Trial Services, Inc.Long Beach, California, United States, 90806 Entertainment Medical GroupLos Angeles, California, United States, 90036 Gastrointestinal Biosciences Clinical Trials, LlcLos Angeles, California, United States, 90067 Alliance Clinical Research, LlcPoway, California, United States, 92064|Colorado Springs, Colorado, United States, 80903|Clearwater, Florida, United States, 33756-3839 West Coast Endoscopy CenterClearwater, Florida, United States, 33756 Gastro FloridaClearwater, Florida, United States, 33762 University Of Miami Clinical Research BuildingMiami, Florida, United States, 33136 University Of Miami Crohn'S And Colitis CenterMiami, Florida, United States, 33136 University Of Miami Hospital And ClinicsMiami, Florida, United States, 33136 University Of Miami HospitalMiami, Florida, United States, 33136 Millenia Surgery CenterOrlando, Florida, United States, 32811 Hmd Research LlcOrlando, Florida, United States, 32819|Shawnee Mission, Kansas, United States, 66217|Houma, Louisiana, United States, 70360 Gulf Coast Surgical CenterHouma, Louisiana, United States, 70360 The Hearing Center (Audiology)Houma, Louisiana, United States, 70360|Chevy Chase, Maryland, United States, 20815 Mgg Group Co., Inc., Chevy Chase Clinical ResearchChevy Chase, Maryland, United States, 20815 Capitol ResearchRockville, Maryland, United States, 20850|Boston, Massachusetts, United States, 02115 Mass Eye And Ear, LongwoodBoston, Massachusetts, United States, 02115 Brigham And Women'S HospitalBoston, Massachusetts, United States, 02215 Brigham And Women'S HospitalChestnut Hill, Massachusetts, United States, 02467 Umass Memorial Medical CenterWorcester, Massachusetts, United States, 01655 University Of Massachusetts Medical SchoolWorcester, Massachusetts, United States, 01655|Caro, Michigan, United States, 48723 Clinical Research Institute Of Michigan, LlcChesterfield, Michigan, United States, 48047 Eastside Endoscopy CenterMacomb, Michigan, United States, 48044 Eastside Endoscopy CenterSaint Clair Shores, Michigan, United States, 48081|New York, New York, United States, 10021 New York Presbyterian Hospital - Weill Cornell Medical College (Colonoscopy)New York, New York, United States, 10065 New York Presbyterian Hospital - Weill Cornell Medical College Investigational PharmacyNew York, New York, United States, 10065 Weill Cornell Medical College - New York Presbyterian Hospital (Endoscopy Suite)New York, New York, United States, 10065 Weill Cornell Medical College - New York Presbyterian HospitalNew York, New York, United States, 10065 Digiovanna Institute For Medical Education And ResearchNorth Massapequa, New York, United States, 11758-1853|Chapel Hill, North Carolina, United States, 27514 Unc Hospitals Endoscopy Center At MeadowmontChapel Hill, North Carolina, United States, 27517 University Of North Carolina At Chapel HillChapel Hill, North Carolina, United States, 27599 Gastroenterology Associates Of The Piedmont, PaWinston-Salem, North Carolina, United States, 27103 Pmg Research Of Winston-Salem, LlcWinston-Salem, North Carolina, United States, 27103|Kingsport, Tennessee, United States, 37660 Holston Valley Surgery CenterKingsport, Tennessee, United States, 37660 Vanderbilt University Medical CenterNashville, Tennessee, United States, 37212-1375 Vanderbilt University Medical CenterNashville, Tennessee, United States, 37212-1610 Vanderbilt University Medical Center - Gi Endoscopy LabNashville, Tennessee, United States, 37232-5543 Vanderbilt University Medical CenterNashville, Tennessee, United States, 37232-7610 Vanderbilt University Medical Center - Gi Research RegulatoryNashville, Tennessee, United States, 37232|Arlington, Texas, United States, 76012 Envision Imaging (Cxr)Arlington, Texas, United States, 76012 Texas Clinical Research Institiute, LlcArlington, Texas, United States, 76012 Hrmd ResearchDallas, Texas, United States, 75240 Hermann Drive Surgical HospitalHouston, Texas, United States, 77004 Pearland Surgery CenterHouston, Texas, United States, 77047 Gulf Coast Research Group, LlcHouston, Texas, United States, 77098 Lonestar Endoscopy, LlpSouthlake, Texas, United States, 76092 Texas Digestive Disease ConsultantsSouthlake, Texas, United States, 76092|Fairfax, Virginia, United States, 22031","Alabama|California|Colorado|Florida|Kansas|Louisiana|Maryland|Massachusetts|Michigan|New York|North Carolina|Tennessee|Texas|Virginia","Australia|Austria|Belgium|Bosnia And Herzegovina|Canada|Croatia|Czechia|France|Georgia|Germany|Hungary|Italy|Lebanon|Poland|Saudi Arabia|Serbia|Slovakia|South Africa|Spain|Switzerland|Tunisia|Turkey|Ukraine|United Arab Emirates|United States","New South Wales Concord Repatriation General Hospital|Queensland Mater Misericordiae Ltd|Saint John Of God Health Care Inc.|Victoria Ballarat Base Hospital|Akh Wien Universitaetsklinik Fuer Innere Medizin Iii|University Hospital Brussels|Javna Zdravstvena Ustanova Univerzitetski Klinicki Centar Republike Srpske,|Manitoba Winnipeg Regional Health Authority - Health Sciences Centre, Winnipeg|Ontario HÃ´pital Montfort|Hrvatska Klinicki Bolnicki Centar Sestre Milosrdnice|Klinicki Bolnicki Centar Rijeka, Odjel Za Gastroenterologiju|Lekarna Altea|Hospital|The First University Clinic Of Tsmu|Paian Med Research Gmbh|Bekes Megyei Kozponti Korhaz, Rethy Pal Tagkorhaz|A.O.U. Policlinico G. Martino|Bari Irccs Saverio De Bellis|Bs A.O.Spedali Civili|Cz Univ. \"Magna Graecia\" Di Catanzaro|Mb Asst Monza|Milan Istituto Clinico Humanitas Irccs - Ibd Center|Milano Asst Rhodense - Ospedale Di Circolo Di Rho|Saint George Hospital University Medical Center|Niepubliczny Zaklad Opieki Zdrowotnej All-Medicus|Silesia H-T. Centrum Medyczne-Endoterapia|King Abdulaziz Medical City|Beograd Klinicko Bolnicki Centar \"Bezanijska Kosa\"|Klinicko Bolnicki Centar Zvezdara, Klinika Za Interne Bolesti,|Srbija Klinicki Centar Srbije, Klinika Za Gastroenterohepatologiju|Fakultna Nemocnica S Poliklinikou F.D. Roosevelta Banska Bystrica|, Gauteng Lenasia Clinical Trial Centre|, Western Cape Dr Wright Private Practice|Cantabria Hospital Universitario Marques De Valdecilla|Hospital Universitario Ramon Y Cajal|Verein Ibd Study Group|La Rabta Hospital|Ankara Universitesi Tip Fakultesi, Ibn-I Sina Hastanesi, Ic Hastaliklari Anabilim Dali,|Regional Municipal Institution \"Chernivtsi Regional Clinical Hospital\", Gastroenterology Department,|Al Baraha Hospital - Moh|Dothan Surgery Center|Brighton Surgical Center|Front Range Endoscopy Center|Gastro Florida|Westglen Gastrointestinal Consultants, P.A.|Cronola, Llc|Chevy Chase Endoscopy Center|Brigham And Women's Hospital|Caro Health Plaza|Weill Cornell Medical College (Clinical Site)|Unc Hospitals|Holston Medical Group|Cross Timbers Surgery Center L.P. (Colonoscopy)|Verity Research, Inc.",{"$nulls":3},"Pfizer CT.gov Call Center","2019-09-18","2020-05-25T16:36:05.709","2020-05-26T17:10:42.972","NCT03395184"]
["5ecbf3f5feab101b1553083c","NCT03395184","2019-10-25","Pfizer","PFE","Recruiting","Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PFâ€‘06700841 In Subjects With Moderate To Severe Crohn's Disease","Brepocitinib|Pf-06651600","JAK1 Inhibitor|TYK2 Inhibitor|JAK1 Inhibitor|JAK3 Inhibitor","Yes","['Brepocitinib', 'Pf-06651600']","Yes","['TYK2 Inhibitor', 'JAK3 Inhibitor']","Phase 2",2,250,"Anticipated","2018-02-02","2022-11-30","DAS","Disease Activity Score",{"$nulls":3},"The objectives of this study are to evaluate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-06651600 (200 mg for 8 weeks followed by 50 mg for 4 weeks) dosed once daily and PF-06700841 (60 mg for 12 weeks) dosed once daily during an induction period of 12 weeks, followed by an open label extension period at doses of 50 mg and 30 mg of PF 06651600 and PF 06700841, respectively, for 52 weeks.",null,"A PHASE 2A, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ORAL PF-06651600 AND PF-06700841 AS INDUCTION AND OPEN LABEL EXTENSION TREATMENT IN SUBJECTS WITH MODERATE TO SEVERE CROHN'S DISEASE","B7981007","Crohn's Disease","Crohn Disease","Gastrointestinal Diseases","Gastrointestinal","Experimental","PF-06700841 or placebo|PF-06651600 or placebo",null,"Drug","Placebo PF-06700841|PF-06700841|Placebo PF-06651600|PF-06651600","12 weeks, followed by PF-06700841, 30 mg QD for 52 weeks.|60 mg QD for 12 weeks followed by 30 mg QD for up to 52 weeks|12 weeks, followed by PF-06651600, 50 mg QD for 52 weeks|200 mg QD for 8 weeks, followed by 50 mg QD up to 56 weeks",null,"PF-06700841 or placebo|PF-06651600 or placebo","\n\n 1. Male and/or female subjects 18 years to 75 years of age\n 2. Documented diagnosis of ileal, ileocolonic, or colonic CD with a minimum disease duration of 3 months, as determined by endoscopic and histopathology assessment.\n 3. Endoscopic confirmation of active disease with total SES CD total score of at least 7. For isolated ileal disease, SES CD total score should be at least 4.\n 4. An average daily liquid/soft stool frequency (SF) greater than or equal to 2.5 or daily abdominal pain (AP) greater than or equal to 2.0.\n 5. Must have inadequate response to, loss of response to, or intolerance to at least one conventional therapy for CD:â€¢Steroids; Immunosuppressants (azathioprine [AZA], 6 MP, or methotrexate [MTX]); Anti TNF inhibitors (infliximab, adalimumab,certolizumab); Anti integrin inhibitors (eg, vedolizumab); Anti IL 12/23 inhibitor (ustekinumab).\n    \n    \n 6. Subjects currently receiving the following treatment for CD are eligible providing they have been on stable doses as described below: * Oral corticosteroids (prednisone or equivalent up to 25 mg/day; budesonide up to 9 mg/day). Stable dose for at least 2 weeks prior to baseline. If oral corticosteroids have been recently discontinued, they must have been stopped at least 2 weeks prior to baseline. Decreases in steroid use due to AEs are allowed.\n     * Oral 5 ASA or sulfasalazine are allowed providing that the dose is stable for at least 4 weeks prior to baseline.\n     * Crohn's disease related antibiotics are allowed providing that the dose is stable for at least 4 weeks prior to baseline. If antibiotics are stopped prior to baseline, they must be discontinued at least 4 days prior to baseline.\n    \n    \n\n","\n\n 1.  Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, diverticular disease, ulcerative colitis (UC), or clinical findings suggestive of UC.\n 2.  Presence of active (draining) fistulae or intra abdominal or perineal abscesses.\n 3.  Strictures with obstructive symptoms.\n 4.  Short bowel syndrome.\n 5.  History of bowel perforation requiring surgical intervention within the past 12 months.\n 6.  Previous bowel surgery resulting in an existing stoma. Subjects who have a j pouch are excluded, as a j pouch can result in a stoma.\n 7.  History of bowel surgery within 6 months prior to baseline.\n 8.  Subjects displaying clinical signs of fulminant colitis or toxic megacolon.\n 9.  Subjects with primary sclerosing cholangitis.\n 10. Subjects with evidence of colonic adenomas, dysplasia or neoplasia.\n 11. Abnormal findings on the chest x ray film such as presence of tuberculosis (TB), general infections, heart failure, or malignancy.\n 12. Any history of either untreated or inadequately treated latent or active TB infection, current treatment for active or latent TB infection or evidence of currently active TB by chest x ray, residing with or frequent close contact with individual(s) with active TB.\n 13. Subjects receiving the following therapies within the time period described below or expected to receive any of these therapies during the study period: 1.  >9 mg/day of oral budesonide or >25 mg/day of prednisone or equivalent oral systemic corticosteroid dose within 2 weeks prior to baseline.\n      2.  IV, IM (parenteral), or topical (rectal) treatment of 5 ASA or corticosteroid enemas/suppositories within 2 weeks prior to baseline.\n      3.  Azathioprine, 6 mercaptopurine, or methotrexate within 2 weeks prior to baseline.\n      4.  Anti TNF inhibitors (or biosimilars thereof) as described below: * Infliximab within 8 weeks prior to baseline;\n           * Adalimumab within 8 weeks prior to baseline;\n           * Certolizumab within 8 weeks prior to baseline;\n          \n          \n      5.  Anti integrin inhibitors (eg, vedolizumab) within 8 weeks prior to baseline.\n      6.  Ustekinumab within 8 weeks prior to baseline.\n      7.  Interferon therapy within 8 weeks prior to baseline.\n      8.  Subjects with prior treatment with lymphocyte depleting agents/therapies within 1 year prior to baseline (eg, CamPath[alemtuzumab], alkylating agents [eg, cyclophosphamide or chlorambucil], total lymphoid irradiation, etc).\n      9.  Subjects who have received rituximab or other selective B lymphocyte depleting agents within 1 year prior to baseline.\n      10. Subjects previously receiving leukocyte apheresis, including selective lymphocyte, monocyte, or granulocyte apheresis, or plasma exchange within 6 months prior to baseline.\n      11. Other marketed immunosuppressants or biologics with immunomodulatory properties within 3 months prior to baseline.\n      12. Subjects who have received other JAK inhibitors within 3 months prior to baseline.\n      13. Subjects who have not responded to or have been intolerant of other JAK inhibitors.\n      14. Other investigational procedures(s) or product(s), such as immunosuppressants used in transplantation (eg, mycophenolate mofetil, cyclosporine, rapamycin, or tacrolimus) or live (attenuated) vaccine within 30 days prior to baseline.","TNF","tumor necrosis factor","Protein","Lung, Breast, Ovary","Actual","2018-01-10","Actual","Anticipated","2022-11-30","Anticipated","2019-10-01","2017-12-05","2018-01-03","2019-10-24","Yes",null,"Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years","75 Years","All",null,"No","Yes\nPfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",null,"URL: https://pmiform.com/clinical-trial-info-request?StudyID=B7981007 [https://pmiform.com/clinical-trial-info-request?StudyID=B7981007] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To obtain contact information for a study center near you, click here.",null,"Yes","No",{"$nulls":17},"2017-003359-43|PIZZICATO","EudraCT Number|Alias Study Number","Proportion of subjects achieving clinically meaningful endoscopic improvement (reduction of more than or equal to 3 points from baseline in Simplified Endoscopic Activity Score for Crohn's Disease (SES-CD) at Week 12","12 weeks",null,"Number of participants with potentially clinically important serious infections findings|Mean change from baseline in SES-CD score at Week 12.|Proportion of subjects achieving SES-CD 25 and SES-CD 50 at Week 12.|Proportion of subjects achieving endoscopic remission (SES-CD less than or equal to 2) at Week 12.|Proportion of subjects achieving mucosal healing at Week 12.|Number of subjects with adverse events|Number of subjects with serious adverse events|Number of subjects with electrocardiogram findings of potential clinical importance.|Number of subjects withdrawal due to adverse events|Number of subjects with vital signs findings of potential clinical importance.|Number of subjects with laboratory tests findings of potential clinical importance.|Proportion of subjects achieving SES CD 25 and SES CD 50 at Week 64 among subjects who achieved SES CD 25 and SES CD 50 at week 12 respectively.|Proportion of subjects achieving clinically meaningful endoscopic improvement (CMEI response) at week 64 among subjects who achieved CMEI response at Week 12.","64 weeks|Baseline, week 12|Number of subjects achieving SES-CD 25 and SES-CD 50 at Week 12.|Number of subjects achieving endoscopic remission (SES-CD less than or equal to 2) at Week 12.|Number of subjects achieving mucosal healing at Week 12.|Number of participants with reported adverse events|Number of participants with reported serious adverse events|Number of participants with potentially clinically important electrocardiogram findings.|Number of subjects withdrawal due to adverse events.|Number of participants with potentially clinically important vital signs findings.|Number of participants with potentially clinically important laboratory findings.|Number of subjects achieving SES-CD 25 and SES-CD 50 at Week 64 among subjects who achieved SES CD 25 and SES CD 50 at week 12|Number of subject achieving clinically meaningful endoscopic improvement (CMEI response) at week 64 among subjects who achieved CMEI response at week 12.","Baseline, week 12|Week 12|Baseline up to 64 weeks|Baseline u to 64 weeks|week 64","ClinicalTrials.gov_Inquiries@pfizer.com","Pfizer CT.gov Call Center","1-800-718-1021","Concord, New South Wales, Australia, 2139|South Brisbane, Queensland, Australia, 4101|Subiaco, Western|Ballarat, Victoria, Australia, 3350|Wien, Austria, 1090|Jette, Belgium, 1090 University Hospitals LeuvenLeuven, Belgium, 3000 Chc - Saint-JosephLiÃ¨ge, Belgium, 4000|Banja Luka, Bosnia And Herzegovina, 78000 Sveucilisna Klinicka Bolnica Mostar,Mostar, Bosnia And Herzegovina, 88000|Winnipeg, Manitoba, Canada, R3A 1R9|Ottawa, Ontario, Canada, K1K 0T2|Montreal, Quebec, Canada, H1T 2M4|Zagreb, Hrvatska, Croatia, 10000|Rijeka, Croatia, 51000 Klinicki Bolnicki Centar Split, Zavod Za GastroenterologijuSplit, Croatia, 21000 Opca Bolnica Zadar, Odjel Za GastroenterologijuZadar, Croatia, 23000 Klinicka Bolnica Dubrava ZagrebZagreb, Croatia, 10000 Klinicki Bolnicki Centar Zagreb, Zavod Za Gastroenterologiju I HepatologijuZagreb, Croatia, 10000|Bilina, Czechia, 41801 Nemocnice Horovice, A.S.Horovice, Czechia, 268 31 Hepato-Gastroenterologie Hk S.R.O.Hradec Kralove, Czechia, 500 12 Medialpharma S.R.O.Hradec Kralove, Czechia, 500 12 Gastroenterologicka Ambulance A EndoskopieMost, Czechia, 43401 Vseobecna Fakultni NemocnicePraha 2, Czechia, 128 08 VÅ¡eobecnÃ¡ FakultnÃ­ Nemocnice V PrazePraha 2, Czechia, 128 08 Lekarna Sv. AnnaPraha 3, Czechia, 130 00 Egk S.R.O. - Sanatorium Sv. AnnyPraha 3, Czechia, 13000 Fakultni Nemocnice V MotolePraha 5, Czechia, 150 06 FakultnÃ­ Nemocnice V MotolePraha 5, Czechia, 150 06 Nemocnice Strakonice, A.S., Interni OddeleniStrakonice, Czechia, 386 01 Nemocnice Strakonice, A.S.Strakonice, Czechia, 386 29|Achrafieh, Beirut, Lebanon|Tbilisi, Georgia, 0141 David Tatishvili Medical CenterTbilisi, Georgia, 0186|Berlin, Germany, 10318 Krankenhaus Waldfriede E.V.,Berlin, Germany, 14163 Universitaetsklinikum BonnBonn, Germany, 53127 Universitaetsklinikum Schleswig-HolsteinKiel, Germany, 24105 UniversitÃ¤tsklinikum Giessen Und Marburg GmbhMarburg, Germany, 35043|Bekescsaba, Hungary, 5600 Semmelweis Egyetem, Ii. Belgyogyaszati KlinikaBudapest, Hungary, 1088 Szent Janos Korhaz Es Eszak-Budai Egyesitett Korhazak[Active, Not Recruiting]Budapest, Hungary, 1125 Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz, Endoszkopos LaboratoriumGyula, Hungary, 5700 Clinfan Szolgaltato Kft.Szekszard, Hungary, 7100 Csolnoky Ferenc Korhaz Belgyogyaszati Centrum I. Belgyogyaszati OsztalyVeszprem, Hungary, 8200|Messina, Italy, 98125 Aou Policlinico Di ModenaModena, Italy, 41124 Azienda Ospedaliera Di PadovaPadova, Italy, 35128 Policlinico Universitario Campus Bio-MedicoRoma, Italy, 00128 Policlinico Gemelli/Complesso Integrato ColumbusRome, Italy, 00168 Korea, Republic Of, Korea Kyungpook National University HospitalDaegu, Korea, Korea, Republic Of, 41944 Korea, Republic Of Kyung Hee University HospitalSeoul, Korea, Republic Of, 02447 Kangbuk Samsung HospitalSeoul, Korea, Republic Of, 03181 Severance Hospital, Yonsei University Health SystemSeoul, Korea, Republic Of, 03722 The Catholic University Of Korea, Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591|Castellana Grotte, Bari, Italy, 70013|Brescia, Bs, Italy, 25123|Catanzaro, Cz, Italy, 88100|Monza, Mb, Italy, 20090|Rozzano, Milan, Italy, 20089|Rho, Milano, Italy, 20017|Achrafieh, Lebanon American University Of Beirut Medical CenterBeirut, Lebanon Ain Wazein Medical VillageEl Chouf, Lebanon Centre Hospitalier Universitaire Notre Dame De SecoursJbeil, Lebanon Hammoud Hospital University Medical CenterSaida, Lebanon|Katowice, Poland, 40-659 Etg KielceKielce, Poland, 25-355 Indywidualna Specjalistyczna Praktyka Lekarska Maciej ZymlaKnurow, Poland, 44-190 Szpital W Knurowie Sp. Z O.O.Knurow, Poland, 44-190 Centrum Badan Klinicznych JciKrakow, Poland, 30-348 Marta Dagmara Banach Marta Banach Specjalistyczny Gabinet NeurologicznyKrakow, Poland, 30-539 Centrum Medyczne EvitaKrakow, Poland, 31-153 Szpital Specjalistyczny Im. Ludwika Rydygiera W Krakowie Sp. Z O.O.Krakow, Poland, 31-826 Centrum Medyczne Szpital Swietej Rodziny Sp Z O.O.Lodz, Poland, 90-302 Pracownia Endoskopii Centrum Medyczne Szpital Swietej Rodziny Sp Z O.O.Lodz, Poland, 90-302 Medical Magnus ClinicLodz, Poland, 90-552 Wojewodzki Szpital Specjalistyczny Im. Bieganskiego W LodziLodz, Poland, 91-347 Gastromed Sp. Z O.O.Lublin, Poland, 20-582 Ai Centrum Medyczne Sp. Z O.O. Sp.K.Poznan, Poland, 61-113 Korczowski Bartosz Gabinet LekarskiRzeszow, Poland, 35-302 Endoskopia Sp. Z O. O.Sopot, Poland, 81-756 Szpital Sredzki Serca Jezusowego Sp. Z O.O.Sroda Wielkopolska, Poland, 63-000 Ez-Med Sp. Z O.O. Sp.K.Swidnica, Poland, 58-100 Pracownia Endoskopii Szpital MswSzczecin, Poland, 70-001 Twoja Przychodnia Szczecinskie Centrum MedyczneSzczecin, Poland, 71-434 Gastromed Kopon, Zmudzinski I Wspolnicy Sp.J.Torun, Poland, 87-100 Centrum Zdrowia MdmWarszawa, Poland, 00-635 Centrum Diagnostyczno-Lecznicze Barska Sp. Z O. O.Wloclawek, Poland, 87-800 Melita Medical Sp. Z O.O.Wroclaw, Poland, 50-449 Centrum Gastrologiczno HepatologiczneWroclaw, Poland, 50-555 Planetmed Sp. Z.O.O.Wroclaw, Poland, 52-210 LexmedicaWroclaw, Poland, 53-114 Russian Federation, Sestroretsk Spb Sbih \"City Hospital #40 Of The Kurortnyi Region\"Saint-Petersburg, Sestroretsk, Russian Federation, 197706 Russian Federation Llc \"Alliance Biomedical-Ural Group\"Izhevsk, Russian Federation, 426061 Clinic Of Fsbei He Ksmu Moh RfKrasnodar, Russian Federation, 350072 Llc \"Olla-Med\"Moscow, Russian Federation, 105554 Sechenov University On The Base Of Institute Of Translational Medicine And BiotechnologyMoscow, Russian Federation, 119435 Limited Liability Company \"Medical Center Sibnovomed\"Novosibirsk, Russian Federation, 630005 Federal State Budgetary Scientific Institution \"Scientific Research Institute Of Physiology AndNovosibirsk, Russian Federation, 630117 Clinic At Fsbei He \"Omsk State Medical University\" Moh RfOmsk, Russian Federation, 644050 Llc \"New Clinic\"Pyatigorsk, Russian Federation, 357500 Limited Liability Company \"Riat\"Saint-Petersburg, Russian Federation, 195220 Saint-Petersburg State Budgetary Healthcare Institution \"City Hospital #26\"Saint-Petersburg, Russian Federation, 196247 Private Institution Educational Organization Of Higher EducationSamara, Russian Federation, 443011 Non-State Healthcare Institution 'Railway Clinical Hospital At Samara Station Of Open Joint StockSamara, Russian Federation, 443029 Saint-Petersburg State Budgetary Healthcare Institution \"City Clinical Hospital Of The RighteousSt. Petersburg, Russian Federation, 197706|Tychy, Silesia, Poland, 43-100|Riyadh, Saudi Arabia, 11426 King Khalid University HospitalRiyadh, Saudi Arabia, 11472|Zemun, Beograd, Serbia, 11080|Beograd, Serbia, 11000 Klinicko Bolnicki Centar Zemun, Klinika Za Internu Medicinu,Zemun, Beograd, Serbia, 11080|Beograd, Srbija, Serbia, 11000 Klinicki Centar KragujevacKragujevac, Srbija, Serbia, 34000 Klinicki Centar NisNis, Srbija, Serbia, 18000 Opsta Bolnica SuboticaSubotica, Srbija, Serbia, 24000 Opsta Bolnica \"Djordje Joanovic\", Odeljenje Interno, Odsek GastroenterologijaZrenjanin, Srbija, Serbia, 23000|Banska Bystrica, Slovakia, 975 17 Breznianske Centrum Gastroenterologie S.R.O.Brezno, Slovakia, 97701 Km Management Spol. S.R.O.Nitra, Slovakia, 949 01 Accout Center S.R.O. Gastroenterologicka AmbulanciaSahy, Slovakia, 936 01 Endomed, S.R.O.Vranov Nad Toplou, Slovakia, 093 01|Lenasia, Gauteng, South Africa, 1827 Wits Clinical Research Trial SiteParktown, Gauteng, South Africa, 2193 Wits Clinical Reasearch - Wits Bara Clinical Trial SiteSoweto, Gauteng, South Africa, 2013|Claremont, Western Cape, South Africa, 7708|Santander, Cantabria, Spain, 39008|Madrid, Spain, 28034 Hospital Universitario Virgen Del RocioSevilla, Spain, 41013 Hospital Universitari I Politecnic La FeValencia, Spain, 46026|Bern, Switzerland, Ch - 3012 UniversitÃ¤tsspital ZÃ¼richZÃ¼rich, Switzerland, Ch-8091|Tunis, Tunisia, 1007 Habib Thameur HospitalTunis, Tunisia, 1008|Ankara, Turkey, 06100 Ankara Universitesi Tip Fakultesi, Ibn-I Sina HastanesiAnkara, Turkey, 06100 Hacettepe Universitesi Tip FakultesiAnkara, Turkey, 06230 Bezmialem Vakif Universitesi Tip Fakultesi HastanesiIstanbul, Turkey, 34093 Istanbul Universitesi Cerrahpasa Tip FacultesiIstanbul, Turkey, 34098 Istanbul Universitesi Cerrahpasa Tip FakultesiIstanbul, Turkey, 34098 Erciyes Universitesi Tip FakultesiKayseri, Turkey, 38039 Kocaeli Universitesi Tip FakultesiKocaeli, Turkey, 41380 Mersin Universitesi Tip Fakultesi Hastanesi, Ic HastaliklariMersin, Turkey, 33110 Mersin Universitesi Tip Fakultesi HastanesiMersin, Turkey, 33110 Karadeniz Teknik Universitesi Tip Fakultesi, Ic HastaliklariTrabzon, Turkey, 61080 Karadeniz Teknik Universitesi Tip FakultesiTrabzon, Turkey, 61080 Bulent Ecevit Universitesi Tip FakultesiZonguldak, Turkey, 67600|Chernivtsi, Ukraine, 58001 Regional Municipal Institution \"Chernivtsi Regional Clinical Hospital\", Surgery DepartmentChernivtsi, Ukraine, 58001 Municipal Healthcare Institution Kharkiv City Clinical Hospital #2 N.A. Prof. O.O. ShalimovKharkiv, Ukraine, 61037 Private Enterprise Of Private Manufacturing Company \"Acinus\", Medical And Diagnostic CenterKropyvnytskyi, Ukraine, 25006 Kyiv Municipal Clinical Hospital #18, Proctology DepartmentKyiv, Ukraine, 01030 Medical Center \"Universal Clinic Oberig\" Of \"Kapital\" Llc, Gastro CenterKyiv, Ukraine, 03680 Lviv Clinical Hospital On Railway Transport Of Health Care Center Branch Of Pjsc Ukrainian RailwayLviv, Ukraine, 79007 Vinnytsia City Clinical Hospital No.1Vinnytsia, Ukraine, 21000 Private Small-Scale Enterprise Medical Center \"Pulse\"Vinnytsia, Ukraine, 21001 Vinnytsia Regional Clinical Hospital For War VeteransVinnytsia, Ukraine, 21005 Vinnytsia Regional Clinical Hospital N.A. M.I.PyrohovVinnytsia, Ukraine, 21018|Dubai, United Arab Emirates, Po Box 505240 Al Baraha Hospital - MohDubai, United Arab Emirates|Dothan, Alabama, United States, 36301 Gut P.C., Dba Digestive Health Specialists Of The SoutheastDothan, Alabama, United States, 36305|Beverly Hills, California, United States, 90210 Long Beach Clinical Trial Services, Inc.Long Beach, California, United States, 90806 Entertainment Medical GroupLos Angeles, California, United States, 90036 Gastrointestinal Biosciences Clinical Trials, LlcLos Angeles, California, United States, 90067 Alliance Clinical Research, LlcPoway, California, United States, 92064|Colorado Springs, Colorado, United States, 80903|Clearwater, Florida, United States, 33756-3839 West Coast Endoscopy CenterClearwater, Florida, United States, 33756 Gastro FloridaClearwater, Florida, United States, 33762 Uf Health Jacksonville - Gastroenterology EmersonJacksonville, Florida, United States, 32207 Uf Health Jacksonville - Faculty ClinicJacksonville, Florida, United States, 32209 University Of Miami Clinical Research BuildingMiami, Florida, United States, 33136 University Of Miami Crohn'S And Colitis CenterMiami, Florida, United States, 33136 University Of Miami Hospital And ClinicsMiami, Florida, United States, 33136 University Of Miami HospitalMiami, Florida, United States, 33136 Millenia Surgery CenterOrlando, Florida, United States, 32811 Hmd Research LlcOrlando, Florida, United States, 32819|Boise, Idaho, United States, 83706 Idaho Gastroenterology Associates (Endoscopy Center)Meridian, Idaho, United States, 83642|Shawnee Mission, Kansas, United States, 66217|Houma, Louisiana, United States, 70360 Gulf Coast Surgical CenterHouma, Louisiana, United States, 70360 The Hearing Center (Audiology)Houma, Louisiana, United States, 70360|Chevy Chase, Maryland, United States, 20815 Mgg Group Co., Inc., Chevy Chase Clinical ResearchChevy Chase, Maryland, United States, 20815 Capitol ResearchRockville, Maryland, United States, 20850|Boston, Massachusetts, United States, 02115 Mass Eye And Ear, LongwoodBoston, Massachusetts, United States, 02115 Brigham And Women'S HospitalBoston, Massachusetts, United States, 02215 Brigham And Women'S HospitalChestnut Hill, Massachusetts, United States, 02467 Umass Memorial Medical CenterWorcester, Massachusetts, United States, 01655 University Of Massachusetts Medical SchoolWorcester, Massachusetts, United States, 01655|Caro, Michigan, United States, 48723 Clinical Research Institute Of Michigan, LlcChesterfield, Michigan, United States, 48047 Eastside Endoscopy CenterMacomb, Michigan, United States, 48044 Eastside Endoscopy CenterSaint Clair Shores, Michigan, United States, 48081|New York, New York, United States, 10021 New York Presbyterian Hospital - Weill Cornell Medical College (Colonoscopy)New York, New York, United States, 10065 New York Presbyterian Hospital - Weill Cornell Medical College Investigational PharmacyNew York, New York, United States, 10065 Weill Cornell Medical College - New York Presbyterian Hospital (Endoscopy Suite)New York, New York, United States, 10065 Weill Cornell Medical College - New York Presbyterian HospitalNew York, New York, United States, 10065 Digiovanna Institute For Medical Education And ResearchNorth Massapequa, New York, United States, 11758-1853|Chapel Hill, North Carolina, United States, 27514 Unc Hospitals Endoscopy Center At MeadowmontChapel Hill, North Carolina, United States, 27517 University Of North Carolina At Chapel HillChapel Hill, North Carolina, United States, 27599 Gastroenterology Associates Of The Piedmont, PaWinston-Salem, North Carolina, United States, 27103 Pmg Research Of Winston-Salem, LlcWinston-Salem, North Carolina, United States, 27103|Oklahoma City, Oklahoma, United States, 73112|Kingsport, Tennessee, United States, 37660 Holston Valley Surgery CenterKingsport, Tennessee, United States, 37660 Vanderbilt University Medical CenterNashville, Tennessee, United States, 37212-1375 Vanderbilt University Medical CenterNashville, Tennessee, United States, 37212-1610 Vanderbilt University Medical Center - Gi Endoscopy LabNashville, Tennessee, United States, 37232-5543 Vanderbilt University Medical CenterNashville, Tennessee, United States, 37232-7610 Vanderbilt University Medical Center - Gi Research RegulatoryNashville, Tennessee, United States, 37232|Arlington, Texas, United States, 76012 Envision Imaging (Cxr)Arlington, Texas, United States, 76012 Texas Clinical Research Institiute, LlcArlington, Texas, United States, 76012 Hrmd ResearchDallas, Texas, United States, 75240 Hermann Drive Surgical HospitalHouston, Texas, United States, 77004 Pearland Surgery CenterHouston, Texas, United States, 77047 Gulf Coast Research Group, LlcHouston, Texas, United States, 77098 Lonestar Endoscopy, LlpSouthlake, Texas, United States, 76092 Texas Digestive Disease ConsultantsSouthlake, Texas, United States, 76092|Fairfax, Virginia, United States, 22031","Alabama|California|Colorado|Florida|Idaho|Kansas|Louisiana|Maryland|Massachusetts|Michigan|New York|North Carolina|Oklahoma|Tennessee|Texas|Virginia","Australia|Austria|Belgium|Bosnia And Herzegovina|Canada|Croatia|Czechia|France|Georgia|Germany|Hungary|Italy|Lebanon|Poland|Saudi Arabia|Serbia|Slovakia|South Africa|Spain|Switzerland|Tunisia|Turkey|Ukraine|United Arab Emirates|United States","New South Wales Concord Repatriation General Hospital|Queensland Mater Misericordiae Ltd|Saint John Of God Health Care Inc.|Victoria Ballarat Base Hospital|Akh Wien Universitaetsklinik Fuer Innere Medizin Iii|University Hospital Brussels|Javna Zdravstvena Ustanova Univerzitetski Klinicki Centar Republike Srpske,|Manitoba Winnipeg Regional Health Authority - Health Sciences Centre, Winnipeg|Ontario HÃ´pital Montfort|Quebec Ciusss De L'Est-De-L'Ile-De-Montreal Installation Hopital Maisonneuve-Rosemont|Hrvatska Klinicki Bolnicki Centar Sestre Milosrdnice|Klinicki Bolnicki Centar Rijeka, Odjel Za Gastroenterologiju|Lekarna Altea|Hospital|The First University Clinic Of Tsmu|Paian Med Research Gmbh|Bekes Megyei Kozponti Korhaz, Rethy Pal Tagkorhaz|A.O.U. Policlinico G. Martino|Bari Irccs Saverio De Bellis|Bs A.O.Spedali Civili|Cz Univ. \"Magna Graecia\" Di Catanzaro|Mb Asst Monza|Milan Istituto Clinico Humanitas Irccs - Ibd Center|Milano Asst Rhodense - Ospedale Di Circolo Di Rho|Saint George Hospital University Medical Center|Niepubliczny Zaklad Opieki Zdrowotnej All-Medicus|Silesia H-T. Centrum Medyczne-Endoterapia|King Abdulaziz Medical City|Beograd Klinicko Bolnicki Centar \"Bezanijska Kosa\"|Klinicko Bolnicki Centar Zvezdara, Klinika Za Interne Bolesti,|Srbija Klinicki Centar Srbije, Klinika Za Gastroenterohepatologiju|Fakultna Nemocnica S Poliklinikou F.D. Roosevelta Banska Bystrica|, Gauteng Lenasia Clinical Trial Centre|, Western Cape Dr Wright Private Practice|Cantabria Hospital Universitario Marques De Valdecilla|Hospital Universitario Ramon Y Cajal|Verein Ibd Study Group|La Rabta Hospital|Ankara Universitesi Tip Fakultesi, Ibn-I Sina Hastanesi, Ic Hastaliklari Anabilim Dali,|Regional Municipal Institution \"Chernivtsi Regional Clinical Hospital\", Gastroenterology Department,|Emirates Specialty Hospital|Dothan Surgery Center|Brighton Surgical Center|Front Range Endoscopy Center|Gastro Florida|Treasure Valley Medical Research|Westglen Gastrointestinal Consultants, P.A.|Cronola, Llc|Chevy Chase Endoscopy Center|Brigham And Women's Hospital|Caro Health Plaza|Weill Cornell Medical College (Clinical Site)|Unc Hospitals|Digestive Disease Specialists, Inc.|Holston Medical Group|Cross Timbers Surgery Center L.P. (Colonoscopy)|Verity Research, Inc.",{"$nulls":3},"Pfizer CT.gov Call Center","2019-10-24","2020-05-25T16:36:05.700","2020-05-26T17:10:42.972","NCT03395184"]
["5ecbf3f5e2561b1b11905d08","NCT03395184","2019-12-09","Pfizer","PFE","Recruiting","Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PFâ€‘06700841 In Subjects With Moderate To Severe Crohn's Disease","Brepocitinib|Pf-06651600","JAK1 Inhibitor|TYK2 Inhibitor|JAK1 Inhibitor|JAK3 Inhibitor","Yes","['Brepocitinib', 'Pf-06651600']","Yes","['TYK2 Inhibitor', 'JAK3 Inhibitor']","Phase 2",2,250,"Anticipated","2018-02-02","2022-11-30","DAS","Disease Activity Score",{"$nulls":3},"The objectives of this study are to evaluate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-06651600 (200 mg for 8 weeks followed by 50 mg for 4 weeks) dosed once daily and PF-06700841 (60 mg for 12 weeks) dosed once daily during an induction period of 12 weeks, followed by an open label extension period at doses of 50 mg and 30 mg of PF 06651600 and PF 06700841, respectively, for 52 weeks.",null,"A PHASE 2A, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ORAL PF-06651600 AND PF-06700841 AS INDUCTION AND OPEN LABEL EXTENSION TREATMENT IN SUBJECTS WITH MODERATE TO SEVERE CROHN'S DISEASE","B7981007","Crohn's Disease","Crohn Disease","Gastrointestinal Diseases","Gastrointestinal","Experimental","PF-06700841 or placebo|PF-06651600 or placebo",null,"Drug","Placebo PF-06700841|PF-06700841|Placebo PF-06651600|PF-06651600","12 weeks, followed by PF-06700841, 30 mg QD for 52 weeks.|60 mg QD for 12 weeks followed by 30 mg QD for up to 52 weeks|12 weeks, followed by PF-06651600, 50 mg QD for 52 weeks|200 mg QD for 8 weeks, followed by 50 mg QD up to 56 weeks",null,"PF-06700841 or placebo|PF-06651600 or placebo","\n\n 1. Male and/or female subjects 18 years to 75 years of age\n 2. Documented diagnosis of ileal, ileocolonic, or colonic CD with a minimum disease duration of 3 months, as determined by endoscopic and histopathology assessment.\n 3. Endoscopic confirmation of active disease with total SES CD total score of at least 7. For isolated ileal disease, SES CD total score should be at least 4.\n 4. An average daily liquid/soft stool frequency (SF) greater than or equal to 2.5 or daily abdominal pain (AP) greater than or equal to 2.0.\n 5. Must have inadequate response to, loss of response to, or intolerance to at least one conventional therapy for CD:â€¢Steroids; Immunosuppressants (azathioprine [AZA], 6 MP, or methotrexate [MTX]); Anti TNF inhibitors (infliximab, adalimumab,certolizumab); Anti integrin inhibitors (eg, vedolizumab); Anti IL 12/23 inhibitor (ustekinumab).\n    \n    \n 6. Subjects currently receiving the following treatment for CD are eligible providing they have been on stable doses as described below: * Oral corticosteroids (prednisone or equivalent up to 25 mg/day; budesonide up to 9 mg/day). Stable dose for at least 2 weeks prior to baseline. If oral corticosteroids have been recently discontinued, they must have been stopped at least 2 weeks prior to baseline. Decreases in steroid use due to AEs are allowed.\n     * Oral 5 ASA or sulfasalazine are allowed providing that the dose is stable for at least 4 weeks prior to baseline.\n     * Crohn's disease related antibiotics are allowed providing that the dose is stable for at least 4 weeks prior to baseline. If antibiotics are stopped prior to baseline, they must be discontinued at least 4 days prior to baseline.\n    \n    \n\n","\n\n 1.  Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, diverticular disease, ulcerative colitis (UC), or clinical findings suggestive of UC.\n 2.  Presence of active (draining) fistulae or intra abdominal or perineal abscesses.\n 3.  Strictures with obstructive symptoms.\n 4.  Short bowel syndrome.\n 5.  History of bowel perforation requiring surgical intervention within the past 12 months.\n 6.  Previous bowel surgery resulting in an existing stoma. Subjects who have a j pouch are excluded, as a j pouch can result in a stoma.\n 7.  History of bowel surgery within 6 months prior to baseline.\n 8.  Subjects displaying clinical signs of fulminant colitis or toxic megacolon.\n 9.  Subjects with primary sclerosing cholangitis.\n 10. Subjects with evidence of colonic adenomas, dysplasia or neoplasia.\n 11. Abnormal findings on the chest x ray film such as presence of tuberculosis (TB), general infections, heart failure, or malignancy.\n 12. Any history of either untreated or inadequately treated latent or active TB infection, current treatment for active or latent TB infection or evidence of currently active TB by chest x ray, residing with or frequent close contact with individual(s) with active TB.\n 13. Subjects receiving the following therapies within the time period described below or expected to receive any of these therapies during the study period: 1.  >9 mg/day of oral budesonide or >25 mg/day of prednisone or equivalent oral systemic corticosteroid dose within 2 weeks prior to baseline.\n      2.  IV, IM (parenteral), or topical (rectal) treatment of 5 ASA or corticosteroid enemas/suppositories within 2 weeks prior to baseline.\n      3.  Azathioprine, 6 mercaptopurine, or methotrexate within 2 weeks prior to baseline.\n      4.  Anti TNF inhibitors (or biosimilars thereof) as described below: * Infliximab within 8 weeks prior to baseline;\n           * Adalimumab within 8 weeks prior to baseline;\n           * Certolizumab within 8 weeks prior to baseline;\n          \n          \n      5.  Anti integrin inhibitors (eg, vedolizumab) within 8 weeks prior to baseline.\n      6.  Ustekinumab within 8 weeks prior to baseline.\n      7.  Interferon therapy within 8 weeks prior to baseline.\n      8.  Subjects with prior treatment with lymphocyte depleting agents/therapies within 1 year prior to baseline (eg, CamPath[alemtuzumab], alkylating agents [eg, cyclophosphamide or chlorambucil], total lymphoid irradiation, etc).\n      9.  Subjects who have received rituximab or other selective B lymphocyte depleting agents within 1 year prior to baseline.\n      10. Subjects previously receiving leukocyte apheresis, including selective lymphocyte, monocyte, or granulocyte apheresis, or plasma exchange within 6 months prior to baseline.\n      11. Other marketed immunosuppressants or biologics with immunomodulatory properties within 3 months prior to baseline.\n      12. Subjects who have received other JAK inhibitors within 3 months prior to baseline.\n      13. Subjects who have not responded to or have been intolerant of other JAK inhibitors.\n      14. Other investigational procedures(s) or product(s), such as immunosuppressants used in transplantation (eg, mycophenolate mofetil, cyclosporine, rapamycin, or tacrolimus) or live (attenuated) vaccine within 30 days prior to baseline.","TNF","tumor necrosis factor","Protein","Lung, Breast, Ovary","Actual","2018-01-10","Actual","Anticipated","2022-11-30","Anticipated","2019-12-01","2017-12-05","2018-01-03","2019-12-06","Yes",null,"Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years","75 Years","All",null,"No","Yes\nPfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",null,"URL: https://pmiform.com/clinical-trial-info-request?StudyID=B7981007 [https://pmiform.com/clinical-trial-info-request?StudyID=B7981007] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To obtain contact information for a study center near you, click here.",null,"Yes","No",{"$nulls":17},"2017-003359-43|PIZZICATO","EudraCT Number|Alias Study Number","Proportion of subjects achieving clinically meaningful endoscopic improvement (reduction of more than or equal to 3 points from baseline in Simplified Endoscopic Activity Score for Crohn's Disease (SES-CD) at Week 12","12 weeks",null,"Number of participants with potentially clinically important serious infections findings|Mean change from baseline in SES-CD score at Week 12.|Proportion of subjects achieving SES-CD 25 and SES-CD 50 at Week 12.|Proportion of subjects achieving endoscopic remission (SES-CD less than or equal to 2) at Week 12.|Proportion of subjects achieving mucosal healing at Week 12.|Number of subjects with adverse events|Number of subjects with serious adverse events|Number of subjects with electrocardiogram findings of potential clinical importance.|Number of subjects withdrawal due to adverse events|Number of subjects with vital signs findings of potential clinical importance.|Number of subjects with laboratory tests findings of potential clinical importance.|Proportion of subjects achieving SES CD 25 and SES CD 50 at Week 64 among subjects who achieved SES CD 25 and SES CD 50 at week 12 respectively.|Proportion of subjects achieving clinically meaningful endoscopic improvement (CMEI response) at week 64 among subjects who achieved CMEI response at Week 12.","64 weeks|Baseline, week 12|Number of subjects achieving SES-CD 25 and SES-CD 50 at Week 12.|Number of subjects achieving endoscopic remission (SES-CD less than or equal to 2) at Week 12.|Number of subjects achieving mucosal healing at Week 12.|Number of participants with reported adverse events|Number of participants with reported serious adverse events|Number of participants with potentially clinically important electrocardiogram findings.|Number of subjects withdrawal due to adverse events.|Number of participants with potentially clinically important vital signs findings.|Number of participants with potentially clinically important laboratory findings.|Number of subjects achieving SES-CD 25 and SES-CD 50 at Week 64 among subjects who achieved SES CD 25 and SES CD 50 at week 12|Number of subject achieving clinically meaningful endoscopic improvement (CMEI response) at week 64 among subjects who achieved CMEI response at week 12.","Baseline, week 12|Week 12|Baseline up to 64 weeks|Baseline u to 64 weeks|week 64","ClinicalTrials.gov_Inquiries@pfizer.com","Pfizer CT.gov Call Center","1-800-718-1021","Concord, New South Wales, Australia, 2139|South Brisbane, Queensland, Australia, 4101|Subiaco, Western|Ballarat, Victoria, Australia, 3350|Wien, Austria, 1090|Jette, Belgium, 1090 University Hospitals LeuvenLeuven, Belgium, 3000 Chc - Saint-JosephLiÃ¨ge, Belgium, 4000|Banja Luka, Bosnia And Herzegovina, 78000 Sveucilisna Klinicka Bolnica Mostar,Mostar, Bosnia And Herzegovina, 88000|Winnipeg, Manitoba, Canada, R3A 1R9|Ottawa, Ontario, Canada, K1K 0T2|Montreal, Quebec, Canada, H1T 2M4|Zagreb, Hrvatska, Croatia, 10000|Rijeka, Croatia, 51000 Klinicki Bolnicki Centar Split, Zavod Za GastroenterologijuSplit, Croatia, 21000 Opca Bolnica Zadar, Odjel Za GastroenterologijuZadar, Croatia, 23000 Klinicka Bolnica Dubrava ZagrebZagreb, Croatia, 10000 Klinicki Bolnicki Centar Zagreb, Zavod Za Gastroenterologiju I HepatologijuZagreb, Croatia, 10000|Bilina, Czechia, 41801 Nemocnice Horovice, A.S.Horovice, Czechia, 268 31 Hepato-Gastroenterologie Hk S.R.O.Hradec Kralove, Czechia, 500 12 Medialpharma S.R.O.Hradec Kralove, Czechia, 500 12 Gastroenterologicka Ambulance A EndoskopieMost, Czechia, 43401 Vseobecna Fakultni NemocnicePraha 2, Czechia, 128 08 VÅ¡eobecnÃ¡ FakultnÃ­ Nemocnice V PrazePraha 2, Czechia, 128 08 Lekarna Sv. AnnaPraha 3, Czechia, 130 00 Egk S.R.O. - Sanatorium Sv. AnnyPraha 3, Czechia, 13000 Fakultni Nemocnice V MotolePraha 5, Czechia, 150 06 FakultnÃ­ Nemocnice V MotolePraha 5, Czechia, 150 06 Nemocnice Strakonice, A.S., Interni OddeleniStrakonice, Czechia, 386 01 Nemocnice Strakonice, A.S.Strakonice, Czechia, 386 29|Achrafieh, Beirut, Lebanon|Tbilisi, Georgia, 0141 David Tatishvili Medical CenterTbilisi, Georgia, 0186|Berlin, Germany, 10318 Krankenhaus Waldfriede E.V.,Berlin, Germany, 14163 Universitaetsklinikum BonnBonn, Germany, 53127 Universitaetsklinikum Schleswig-HolsteinKiel, Germany, 24105 UniversitÃ¤tsklinikum Giessen Und Marburg GmbhMarburg, Germany, 35043|Bekescsaba, Hungary, 5600 Semmelweis Egyetem, Ii. Belgyogyaszati KlinikaBudapest, Hungary, 1088 Szent Janos Korhaz Es Eszak-Budai Egyesitett Korhazak[Active, Not Recruiting]Budapest, Hungary, 1125 Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz, Endoszkopos LaboratoriumGyula, Hungary, 5700 Clinfan Szolgaltato Kft.Szekszard, Hungary, 7100 Csolnoky Ferenc Korhaz Belgyogyaszati Centrum I. Belgyogyaszati OsztalyVeszprem, Hungary, 8200|Messina, Italy, 98125 Aou Policlinico Di ModenaModena, Italy, 41124 Azienda Ospedaliera Di PadovaPadova, Italy, 35128 Policlinico Universitario Campus Bio-MedicoRoma, Italy, 00128 Policlinico Gemelli/Complesso Integrato ColumbusRome, Italy, 00168 Korea, Republic Of, Korea Kyungpook National University HospitalDaegu, Korea, Korea, Republic Of, 41944 Korea, Republic Of Kyung Hee University HospitalSeoul, Korea, Republic Of, 02447 Kangbuk Samsung HospitalSeoul, Korea, Republic Of, 03181 Severance Hospital, Yonsei University Health SystemSeoul, Korea, Republic Of, 03722 The Catholic University Of Korea, Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591|Castellana Grotte, Bari, Italy, 70013|Brescia, Bs, Italy, 25123|Catanzaro, Cz, Italy, 88100|Monza, Mb, Italy, 20090|Rozzano, Milan, Italy, 20089|Rho, Milano, Italy, 20017|Dubai, United Arab Emirates, 22241 Emirates Specialty HospitalDubai, United Arab Emirates, Po Box 505240|Achrafieh, Lebanon American University Of Beirut Medical CenterBeirut, Lebanon Ain Wazein Medical VillageEl Chouf, Lebanon Centre Hospitalier Universitaire Notre Dame De SecoursJbeil, Lebanon Hammoud Hospital University Medical CenterSaida, Lebanon|Katowice, Poland, 40-659 Etg KielceKielce, Poland, 25-355 Indywidualna Specjalistyczna Praktyka Lekarska Maciej ZymlaKnurow, Poland, 44-190 Szpital W Knurowie Sp. Z O.O.Knurow, Poland, 44-190 Centrum Badan Klinicznych JciKrakow, Poland, 30-348 Marta Dagmara Banach Marta Banach Specjalistyczny Gabinet NeurologicznyKrakow, Poland, 30-539 Centrum Medyczne EvitaKrakow, Poland, 31-153 Szpital Specjalistyczny Im. Ludwika Rydygiera W Krakowie Sp. Z O.O.Krakow, Poland, 31-826 Centrum Medyczne Szpital Swietej Rodziny Sp Z O.O.Lodz, Poland, 90-302 Pracownia Endoskopii Centrum Medyczne Szpital Swietej Rodziny Sp Z O.O.Lodz, Poland, 90-302 Medical Magnus ClinicLodz, Poland, 90-552 Wojewodzki Szpital Specjalistyczny Im. Bieganskiego W LodziLodz, Poland, 91-347 Gastromed Sp. Z O.O.Lublin, Poland, 20-582 Ai Centrum Medyczne Sp. Z O.O. Sp.K.Poznan, Poland, 61-113 Korczowski Bartosz Gabinet LekarskiRzeszow, Poland, 35-302 Endoskopia Sp. Z O. O.Sopot, Poland, 81-756 Szpital Sredzki Serca Jezusowego Sp. Z O.O.Sroda Wielkopolska, Poland, 63-000 Ez-Med Sp. Z O.O. Sp.K.Swidnica, Poland, 58-100 Pracownia Endoskopii Szpital MswSzczecin, Poland, 70-001 Twoja Przychodnia Szczecinskie Centrum MedyczneSzczecin, Poland, 71-434 Gastromed Kopon, Zmudzinski I Wspolnicy Sp.J.Torun, Poland, 87-100 Centrum Zdrowia MdmWarszawa, Poland, 00-635 Centrum Diagnostyczno-Lecznicze Barska Sp. Z O. O.Wloclawek, Poland, 87-800 Melita Medical Sp. Z O.O.Wroclaw, Poland, 50-449 Centrum Gastrologiczno HepatologiczneWroclaw, Poland, 50-555 Planetmed Sp. Z.O.O.Wroclaw, Poland, 52-210 LexmedicaWroclaw, Poland, 53-114 Russian Federation, Sestroretsk Spb Sbih \"City Hospital #40 Of The Kurortnyi Region\"Saint-Petersburg, Sestroretsk, Russian Federation, 197706 Russian Federation Llc \"Alliance Biomedical-Ural Group\"Izhevsk, Russian Federation, 426061 Clinic Of Fsbei He Ksmu Moh RfKrasnodar, Russian Federation, 350072 Llc \"Olla-Med\"Moscow, Russian Federation, 105554 Sechenov University On The Base Of Institute Of Translational Medicine And BiotechnologyMoscow, Russian Federation, 119435 Limited Liability Company \"Medical Center Sibnovomed\"Novosibirsk, Russian Federation, 630005 Federal State Budgetary Scientific Institution \"Scientific Research Institute Of Physiology AndNovosibirsk, Russian Federation, 630117 Clinic At Fsbei He \"Omsk State Medical University\" Moh RfOmsk, Russian Federation, 644050 Llc \"New Clinic\"Pyatigorsk, Russian Federation, 357500 Limited Liability Company \"Riat\"Saint-Petersburg, Russian Federation, 195220 Saint-Petersburg State Budgetary Healthcare Institution \"City Hospital #26\"Saint-Petersburg, Russian Federation, 196247 Private Institution Educational Organization Of Higher EducationSamara, Russian Federation, 443011 Non-State Healthcare Institution 'Railway Clinical Hospital At Samara Station Of Open Joint StockSamara, Russian Federation, 443029 Saint-Petersburg State Budgetary Healthcare Institution \"City Clinical Hospital Of The RighteousSt. Petersburg, Russian Federation, 197706|Tychy, Silesia, Poland, 43-100|Riyadh, Saudi Arabia, 11426 King Khalid University HospitalRiyadh, Saudi Arabia, 11472|Zemun, Beograd, Serbia, 11080|Beograd, Serbia, 11000 Klinicko Bolnicki Centar Zemun, Klinika Za Internu Medicinu,Zemun, Beograd, Serbia, 11080|Beograd, Srbija, Serbia, 11000 Klinicki Centar KragujevacKragujevac, Srbija, Serbia, 34000 Klinicki Centar NisNis, Srbija, Serbia, 18000 Opsta Bolnica SuboticaSubotica, Srbija, Serbia, 24000 Opsta Bolnica \"Djordje Joanovic\", Odeljenje Interno, Odsek GastroenterologijaZrenjanin, Srbija, Serbia, 23000|Banska Bystrica, Slovakia, 975 17 Breznianske Centrum Gastroenterologie S.R.O.Brezno, Slovakia, 97701 Km Management Spol. S.R.O.Nitra, Slovakia, 949 01 Accout Center S.R.O. Gastroenterologicka AmbulanciaSahy, Slovakia, 936 01 Endomed, S.R.O.Vranov Nad Toplou, Slovakia, 093 01|Lenasia, Gauteng, South Africa, 1827 Wits Clinical Research Trial SiteParktown, Gauteng, South Africa, 2193 Wits Clinical Reasearch - Wits Bara Clinical Trial SiteSoweto, Gauteng, South Africa, 2013|Claremont, Western Cape, South Africa, 7708|Santander, Cantabria, Spain, 39008|Madrid, Spain, 28034 Hospital Universitario Virgen Del RocioSevilla, Spain, 41013 Hospital Universitari I Politecnic La FeValencia, Spain, 46026|Bern, Switzerland, Ch - 3012 UniversitÃ¤tsspital ZÃ¼richZÃ¼rich, Switzerland, Ch-8091|Tunis, Tunisia, 1007 Habib Thameur HospitalTunis, Tunisia, 1008|Ankara, Turkey, 06100 Ankara Universitesi Tip Fakultesi, Ibn-I Sina HastanesiAnkara, Turkey, 06100 Hacettepe Universitesi Tip FakultesiAnkara, Turkey, 06230 Bezmialem Vakif Universitesi Tip Fakultesi HastanesiIstanbul, Turkey, 34093 Istanbul Universitesi Cerrahpasa Tip FacultesiIstanbul, Turkey, 34098 Istanbul Universitesi Cerrahpasa Tip FakultesiIstanbul, Turkey, 34098 Erciyes Universitesi Tip FakultesiKayseri, Turkey, 38039 Kocaeli Universitesi Tip FakultesiKocaeli, Turkey, 41380 Mersin Universitesi Tip Fakultesi Hastanesi, Ic HastaliklariMersin, Turkey, 33110 Mersin Universitesi Tip Fakultesi HastanesiMersin, Turkey, 33110 Karadeniz Teknik Universitesi Tip Fakultesi, Ic HastaliklariTrabzon, Turkey, 61080 Karadeniz Teknik Universitesi Tip FakultesiTrabzon, Turkey, 61080 Bulent Ecevit Universitesi Tip FakultesiZonguldak, Turkey, 67600|Chernivtsi, Ukraine, 58001 Regional Municipal Institution \"Chernivtsi Regional Clinical Hospital\", Surgery DepartmentChernivtsi, Ukraine, 58001 Municipal Healthcare Institution Kharkiv City Clinical Hospital #2 N.A. Prof. O.O. ShalimovKharkiv, Ukraine, 61037 Private Enterprise Of Private Manufacturing Company \"Acinus\", Medical And Diagnostic CenterKropyvnytskyi, Ukraine, 25006 Kyiv Municipal Clinical Hospital #18, Proctology DepartmentKyiv, Ukraine, 01030 Medical Center \"Universal Clinic Oberig\" Of \"Kapital\" Llc, Gastro CenterKyiv, Ukraine, 03680 Lviv Clinical Hospital On Railway Transport Of Health Care Center Branch Of Pjsc Ukrainian RailwayLviv, Ukraine, 79007 Vinnytsia City Clinical Hospital No.1Vinnytsia, Ukraine, 21000 Private Small-Scale Enterprise Medical Center \"Pulse\"Vinnytsia, Ukraine, 21001 Vinnytsia Regional Clinical Hospital For War VeteransVinnytsia, Ukraine, 21005 Vinnytsia Regional Clinical Hospital N.A. M.I.PyrohovVinnytsia, Ukraine, 21018|Abu Dhabi, United Arab Emirates, 112412 Al|Dothan, Alabama, United States, 36301 Gut P.C., Dba Digestive Health Specialists Of The SoutheastDothan, Alabama, United States, 36305|Beverly Hills, California, United States, 90210 Long Beach Clinical Trial Services, Inc.Long Beach, California, United States, 90806 Entertainment Medical GroupLos Angeles, California, United States, 90036 Gastrointestinal Biosciences Clinical Trials, LlcLos Angeles, California, United States, 90067 Alliance Clinical Research, LlcPoway, California, United States, 92064|Colorado Springs, Colorado, United States, 80903|Clearwater, Florida, United States, 33756-3839 West Coast Endoscopy CenterClearwater, Florida, United States, 33756 Gastro FloridaClearwater, Florida, United States, 33762 Uf Health Jacksonville - Gastroenterology EmersonJacksonville, Florida, United States, 32207 Uf Health Jacksonville - Faculty ClinicJacksonville, Florida, United States, 32209 University Of Miami Clinical Research BuildingMiami, Florida, United States, 33136 University Of Miami Crohn'S And Colitis CenterMiami, Florida, United States, 33136 University Of Miami Hospital And ClinicsMiami, Florida, United States, 33136 University Of Miami HospitalMiami, Florida, United States, 33136 Millenia Surgery CenterOrlando, Florida, United States, 32811 Hmd Research LlcOrlando, Florida, United States, 32819|Boise, Idaho, United States, 83706 Idaho Gastroenterology Associates (Endoscopy Center)Meridian, Idaho, United States, 83642|Shawnee Mission, Kansas, United States, 66217|Houma, Louisiana, United States, 70360 Gulf Coast Surgical CenterHouma, Louisiana, United States, 70360 The Hearing Center (Audiology)Houma, Louisiana, United States, 70360|Chevy Chase, Maryland, United States, 20815 Mgg Group Co., Inc., Chevy Chase Clinical ResearchChevy Chase, Maryland, United States, 20815 Capitol ResearchRockville, Maryland, United States, 20850|Boston, Massachusetts, United States, 02115 Mass Eye And Ear, LongwoodBoston, Massachusetts, United States, 02115 Brigham And Women'S HospitalBoston, Massachusetts, United States, 02215 Brigham And Women'S HospitalChestnut Hill, Massachusetts, United States, 02467 Umass Memorial Medical CenterWorcester, Massachusetts, United States, 01655 University Of Massachusetts Medical SchoolWorcester, Massachusetts, United States, 01655|Caro, Michigan, United States, 48723 Clinical Research Institute Of Michigan, LlcChesterfield, Michigan, United States, 48047 Eastside Endoscopy CenterMacomb, Michigan, United States, 48044 Eastside Endoscopy CenterSaint Clair Shores, Michigan, United States, 48081|New York, New York, United States, 10021 New York Presbyterian Hospital - Weill Cornell Medical College (Colonoscopy)New York, New York, United States, 10065 New York Presbyterian Hospital - Weill Cornell Medical College Investigational PharmacyNew York, New York, United States, 10065 Weill Cornell Medical College - New York Presbyterian Hospital (Endoscopy Suite)New York, New York, United States, 10065 Weill Cornell Medical College - New York Presbyterian HospitalNew York, New York, United States, 10065 Digiovanna Institute For Medical Education And ResearchNorth Massapequa, New York, United States, 11758-1853|Chapel Hill, North Carolina, United States, 27514 Unc Hospitals Endoscopy Center At MeadowmontChapel Hill, North Carolina, United States, 27517 University Of North Carolina At Chapel HillChapel Hill, North Carolina, United States, 27599 Gastroenterology Associates Of The Piedmont, PaWinston-Salem, North Carolina, United States, 27103 Pmg Research Of Winston-Salem, LlcWinston-Salem, North Carolina, United States, 27103|Oklahoma City, Oklahoma, United States, 73112|Kingsport, Tennessee, United States, 37660 Holston Valley Surgery CenterKingsport, Tennessee, United States, 37660 Vanderbilt University Medical CenterNashville, Tennessee, United States, 37212-1375 Vanderbilt University Medical CenterNashville, Tennessee, United States, 37212-1610 Vanderbilt University Medical Center - Gi Endoscopy LabNashville, Tennessee, United States, 37232-5543 Vanderbilt University Medical CenterNashville, Tennessee, United States, 37232-7610 Vanderbilt University Medical Center - Gi Research RegulatoryNashville, Tennessee, United States, 37232|Arlington, Texas, United States, 76012 Envision Imaging (Cxr)Arlington, Texas, United States, 76012 Texas Clinical Research Institiute, LlcArlington, Texas, United States, 76012 First Street HospitalBellaire, Texas, United States, 77401 Hrmd ResearchDallas, Texas, United States, 75240 Pearland Surgery CenterHouston, Texas, United States, 77047 Gulf Coast Research Group, LlcHouston, Texas, United States, 77098 Lonestar Endoscopy, LlpSouthlake, Texas, United States, 76092 Texas Digestive Disease ConsultantsSouthlake, Texas, United States, 76092|Fairfax, Virginia, United States, 22031","Alabama|California|Colorado|Florida|Idaho|Kansas|Louisiana|Maryland|Massachusetts|Michigan|New York|North Carolina|Oklahoma|Tennessee|Texas|Virginia","Australia|Austria|Belgium|Bosnia And Herzegovina|Canada|Croatia|Czechia|France|Georgia|Germany|Hungary|Italy|Kuwait|Lebanon|Poland|Saudi Arabia|Serbia|Slovakia|South Africa|Spain|Switzerland|Tunisia|Turkey|Ukraine|United Arab Emirates|United States","New South Wales Concord Repatriation General Hospital|Queensland Mater Misericordiae Ltd|Saint John Of God Health Care Inc.|Victoria Ballarat Base Hospital|Akh Wien Universitaetsklinik Fuer Innere Medizin Iii|University Hospital Brussels|Javna Zdravstvena Ustanova Univerzitetski Klinicki Centar Republike Srpske,|Manitoba Winnipeg Regional Health Authority - Health Sciences Centre, Winnipeg|Ontario HÃ´pital Montfort|Quebec Ciusss De L'Est-De-L'Ile-De-Montreal Installation Hopital Maisonneuve-Rosemont|Hrvatska Klinicki Bolnicki Centar Sestre Milosrdnice|Klinicki Bolnicki Centar Rijeka, Odjel Za Gastroenterologiju|Lekarna Altea|Hospital|The First University Clinic Of Tsmu|Paian Med Research Gmbh|Bekes Megyei Kozponti Korhaz, Rethy Pal Tagkorhaz|A.O.U. Policlinico G. Martino|Bari Irccs Saverio De Bellis|Bs A.O.Spedali Civili|Cz Univ. \"Magna Graecia\" Di Catanzaro|Mb Asst Monza|Milan Istituto Clinico Humanitas Irccs - Ibd Center|Milano Asst Rhodense - Ospedale Di Circolo Di Rho|Hospital - Dubai|Saint George Hospital University Medical Center|Niepubliczny Zaklad Opieki Zdrowotnej All-Medicus|Silesia H-T. Centrum Medyczne-Endoterapia|King Abdulaziz Medical City|Beograd Klinicko Bolnicki Centar \"Bezanijska Kosa\"|Klinicko Bolnicki Centar Zvezdara, Klinika Za Interne Bolesti,|Srbija Klinicki Centar Srbije, Klinika Za Gastroenterohepatologiju|Fakultna Nemocnica S Poliklinikou F.D. Roosevelta Banska Bystrica|, Gauteng Lenasia Clinical Trial Centre|, Western Cape Dr Wright Private Practice|Cantabria Hospital Universitario Marques De Valdecilla|Hospital Universitario Ramon Y Cajal|Verein Ibd Study Group|La Rabta Hospital|Ankara Universitesi Tip Fakultesi, Ibn-I Sina Hastanesi, Ic Hastaliklari Anabilim Dali,|Regional Municipal Institution \"Chernivtsi Regional Clinical Hospital\", Gastroenterology Department,|Cleveland Clinica Abu Dhabi, Department Of Gastroenterology And Hepatology|Dothan Surgery Center|Brighton Surgical Center|Front Range Endoscopy Center|Gastro Florida|Treasure Valley Medical Research|Westglen Gastrointestinal Consultants, P.A.|Cronola, Llc|Chevy Chase Endoscopy Center|Brigham And Women's Hospital|Caro Health Plaza|Weill Cornell Medical College (Clinical Site)|Unc Hospitals|Digestive Disease Specialists, Inc.|Holston Medical Group|Cross Timbers Surgery Center L.P. (Colonoscopy)|Verity Research, Inc.",{"$nulls":3},"Pfizer CT.gov Call Center","2019-12-06","2020-05-25T16:36:05.703","2020-05-26T17:10:42.972","NCT03395184"]
["5ecbf3f5fe30261b1a04820d","NCT03395184","2020-01-18","Pfizer","PFE","Recruiting","Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PFâ€‘06700841 In Subjects With Moderate To Severe Crohn's Disease","Brepocitinib|Pf-06651600","JAK1 Inhibitor|TYK2 Inhibitor|JAK1 Inhibitor|JAK3 Inhibitor","Yes","['Brepocitinib', 'Pf-06651600']","Yes","['TYK2 Inhibitor', 'JAK3 Inhibitor']","Phase 2",2,250,"Anticipated","2018-02-02","2022-11-30","DAS","Disease Activity Score",{"$nulls":3},"The objectives of this study are to evaluate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-06651600 (200 mg for 8 weeks followed by 50 mg for 4 weeks) dosed once daily and PF-06700841 (60 mg for 12 weeks) dosed once daily during an induction period of 12 weeks, followed by an open label extension period at doses of 50 mg and 30 mg of PF 06651600 and PF 06700841, respectively, for 52 weeks.",null,"A PHASE 2A, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ORAL PF-06651600 AND PF-06700841 AS INDUCTION AND OPEN LABEL EXTENSION TREATMENT IN SUBJECTS WITH MODERATE TO SEVERE CROHN'S DISEASE","B7981007","Crohn's Disease","Crohn Disease","Gastrointestinal Diseases","Gastrointestinal","Experimental","PF-06700841 or placebo|PF-06651600 or placebo",null,"Drug","Placebo PF-06700841|PF-06700841|Placebo PF-06651600|PF-06651600","12 weeks, followed by PF-06700841, 30 mg QD for 52 weeks.|60 mg QD for 12 weeks followed by 30 mg QD for up to 52 weeks|12 weeks, followed by PF-06651600, 50 mg QD for 52 weeks|200 mg QD for 8 weeks, followed by 50 mg QD up to 56 weeks",null,"PF-06700841 or placebo|PF-06651600 or placebo","\n\n 1. Male and/or female subjects 18 years to 75 years of age\n 2. Documented diagnosis of ileal, ileocolonic, or colonic CD with a minimum disease duration of 3 months, as determined by endoscopic and histopathology assessment.\n 3. Endoscopic confirmation of active disease with total SES CD total score of at least 7. For isolated ileal disease, SES CD total score should be at least 4.\n 4. An average daily liquid/soft stool frequency (SF) greater than or equal to 2.5 or daily abdominal pain (AP) greater than or equal to 2.0.\n 5. Must have inadequate response to, loss of response to, or intolerance to at least one conventional therapy for CD:â€¢Steroids; Immunosuppressants (azathioprine [AZA], 6 MP, or methotrexate [MTX]); Anti TNF inhibitors (infliximab, adalimumab,certolizumab); Anti integrin inhibitors (eg, vedolizumab); Anti IL 12/23 inhibitor (ustekinumab).\n    \n    \n 6. Subjects currently receiving the following treatment for CD are eligible providing they have been on stable doses as described below: * Oral corticosteroids (prednisone or equivalent up to 25 mg/day; budesonide up to 9 mg/day). Stable dose for at least 2 weeks prior to baseline. If oral corticosteroids have been recently discontinued, they must have been stopped at least 2 weeks prior to baseline. Decreases in steroid use due to AEs are allowed.\n     * Oral 5 ASA or sulfasalazine are allowed providing that the dose is stable for at least 4 weeks prior to baseline.\n     * Crohn's disease related antibiotics are allowed providing that the dose is stable for at least 4 weeks prior to baseline. If antibiotics are stopped prior to baseline, they must be discontinued at least 4 days prior to baseline.\n    \n    \n\n","\n\n 1.  Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, diverticular disease, ulcerative colitis (UC), or clinical findings suggestive of UC.\n 2.  Presence of active (draining) fistulae or intra abdominal or perineal abscesses.\n 3.  Strictures with obstructive symptoms.\n 4.  Short bowel syndrome.\n 5.  History of bowel perforation requiring surgical intervention within the past 12 months.\n 6.  Previous bowel surgery resulting in an existing stoma. Subjects who have a j pouch are excluded, as a j pouch can result in a stoma.\n 7.  History of bowel surgery within 6 months prior to baseline.\n 8.  Subjects displaying clinical signs of fulminant colitis or toxic megacolon.\n 9.  Subjects with primary sclerosing cholangitis.\n 10. Subjects with evidence of colonic adenomas, dysplasia or neoplasia.\n 11. Abnormal findings on the chest x ray film such as presence of tuberculosis (TB), general infections, heart failure, or malignancy.\n 12. Any history of either untreated or inadequately treated latent or active TB infection, current treatment for active or latent TB infection or evidence of currently active TB by chest x ray, residing with or frequent close contact with individual(s) with active TB.\n 13. Subjects receiving the following therapies within the time period described below or expected to receive any of these therapies during the study period: 1.  >9 mg/day of oral budesonide or >25 mg/day of prednisone or equivalent oral systemic corticosteroid dose within 2 weeks prior to baseline.\n      2.  IV, IM (parenteral), or topical (rectal) treatment of 5 ASA or corticosteroid enemas/suppositories within 2 weeks prior to baseline.\n      3.  Azathioprine, 6 mercaptopurine, or methotrexate within 2 weeks prior to baseline.\n      4.  Anti TNF inhibitors (or biosimilars thereof) as described below: * Infliximab within 8 weeks prior to baseline;\n           * Adalimumab within 8 weeks prior to baseline;\n           * Certolizumab within 8 weeks prior to baseline;\n          \n          \n      5.  Anti integrin inhibitors (eg, vedolizumab) within 8 weeks prior to baseline.\n      6.  Ustekinumab within 8 weeks prior to baseline.\n      7.  Interferon therapy within 8 weeks prior to baseline.\n      8.  Subjects with prior treatment with lymphocyte depleting agents/therapies within 1 year prior to baseline (eg, CamPath[alemtuzumab], alkylating agents [eg, cyclophosphamide or chlorambucil], total lymphoid irradiation, etc).\n      9.  Subjects who have received rituximab or other selective B lymphocyte depleting agents within 1 year prior to baseline.\n      10. Subjects previously receiving leukocyte apheresis, including selective lymphocyte, monocyte, or granulocyte apheresis, or plasma exchange within 6 months prior to baseline.\n      11. Other marketed immunosuppressants or biologics with immunomodulatory properties within 3 months prior to baseline.\n      12. Subjects who have received other JAK inhibitors within 3 months prior to baseline.\n      13. Subjects who have not responded to or have been intolerant of other JAK inhibitors.\n      14. Other investigational procedures(s) or product(s), such as immunosuppressants used in transplantation (eg, mycophenolate mofetil, cyclosporine, rapamycin, or tacrolimus) or live (attenuated) vaccine within 30 days prior to baseline.","TNF","tumor necrosis factor","Protein","Lung, Breast, Ovary","Actual","2018-01-10","Actual","Anticipated","2022-11-30","Anticipated","2020-01-01","2017-12-05","2018-01-03","2020-01-15","Yes",null,"Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years","75 Years","All",null,"No","Yes\nPfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",null,"URL: https://pmiform.com/clinical-trial-info-request?StudyID=B7981007 [https://pmiform.com/clinical-trial-info-request?StudyID=B7981007] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To obtain contact information for a study center near you, click here.",null,"Yes","No",{"$nulls":17},"2017-003359-43|PIZZICATO","EudraCT Number|Alias Study Number","Proportion of subjects achieving clinically meaningful endoscopic improvement (reduction of more than or equal to 3 points from baseline in Simplified Endoscopic Activity Score for Crohn's Disease (SES-CD) at Week 12|Number of subjects with adverse events|Number of subjects with serious adverse events|Number of subjects with electrocardiogram findings of potential clinical importance|Number of subjects with laboratory tests findings of potential clinical importance|Number of subjects withdrawal due to adverse events|Number of subjects with vital signs findings of potential clinical importance","12 weeks|Baseline of extension period (Week 12) to week 68",null,"Number of participants with potentially clinically important serious infections findings|Mean change from baseline in SES-CD score at Week 12.|Proportion of subjects achieving SES-CD 25 and SES-CD 50 at Week 12.|Proportion of subjects achieving endoscopic remission (SES-CD less than or equal to 2) at Week 12.|Proportion of subjects achieving mucosal healing at Week 12.|Number of subjects with adverse events|Number of subjects with serious adverse events|Number of subjects with electrocardiogram findings of potential clinical importance.|Number of subjects withdrawal due to adverse events|Number of subjects with vital signs findings of potential clinical importance.|Number of subjects with laboratory tests findings of potential clinical importance.|Proportion of subjects achieving SES CD 25 and SES CD 50 at Week 64 among subjects who achieved SES CD 25 and SES CD 50 at week 12 respectively.|Proportion of subjects achieving clinically meaningful endoscopic improvement (CMEI response) at week 64 among subjects who achieved CMEI response at Week 12.","64 weeks|Baseline, week 12|Number of subjects achieving SES-CD 25 and SES-CD 50 at Week 12.|Number of subjects achieving endoscopic remission (SES-CD less than or equal to 2) at Week 12.|Number of subjects achieving mucosal healing at Week 12.|Number of participants with reported adverse events|Number of participants with reported serious adverse events|Number of participants with potentially clinically important electrocardiogram findings.|Number of subjects withdrawal due to adverse events.|Number of participants with potentially clinically important vital signs findings.|Number of participants with potentially clinically important laboratory findings.|Number of subjects achieving SES-CD 25 and SES-CD 50 at Week 64 among subjects who achieved SES CD 25 and SES CD 50 at week 12|Number of subject achieving clinically meaningful endoscopic improvement (CMEI response) at week 64 among subjects who achieved CMEI response at week 12.","Baseline, week 12|Week 12|Baseline of induction period to week 12|week 64","ClinicalTrials.gov_Inquiries@pfizer.com","Pfizer CT.gov Call Center","1-800-718-1021","Concord, New South Wales, Australia, 2139|South Brisbane, Queensland, Australia, 4101|Subiaco, Western|Ballarat, Victoria, Australia, 3350|Wien, Austria, 1090|Jette, Belgium, 1090 University Hospitals LeuvenLeuven, Belgium, 3000 Chc - Saint-JosephLiÃ¨ge, Belgium, 4000|Banja Luka, Bosnia And Herzegovina, 78000 Sveucilisna Klinicka Bolnica Mostar,Mostar, Bosnia And Herzegovina, 88000|Winnipeg, Manitoba, Canada, R3A 1R9|Ottawa, Ontario, Canada, K1K 0T2|Montreal, Quebec, Canada, H1T 2M4|Zagreb, Hrvatska, Croatia, 10000|Rijeka, Croatia, 51000 Klinicki Bolnicki Centar Split, Zavod Za GastroenterologijuSplit, Croatia, 21000 Opca Bolnica Zadar, Odjel Za GastroenterologijuZadar, Croatia, 23000 Klinicka Bolnica Dubrava ZagrebZagreb, Croatia, 10000 Klinicki Bolnicki Centar Zagreb, Zavod Za Gastroenterologiju I HepatologijuZagreb, Croatia, 10000|Bilina, Czechia, 41801 Nemocnice Horovice, A.S.Horovice, Czechia, 268 31 Hepato-Gastroenterologie Hk S.R.O.Hradec Kralove, Czechia, 500 12 Medialpharma S.R.O.Hradec Kralove, Czechia, 500 12 Gastroenterologicka Ambulance A EndoskopieMost, Czechia, 43401 Vseobecna Fakultni NemocnicePraha 2, Czechia, 128 08 VÅ¡eobecnÃ¡ FakultnÃ­ Nemocnice V PrazePraha 2, Czechia, 128 08 Lekarna Sv. AnnaPraha 3, Czechia, 130 00 Egk S.R.O. - Sanatorium Sv. AnnyPraha 3, Czechia, 13000 Fakultni Nemocnice V MotolePraha 5, Czechia, 150 06 FakultnÃ­ Nemocnice V MotolePraha 5, Czechia, 150 06 Nemocnice Strakonice, A.S., Interni OddeleniStrakonice, Czechia, 386 01 Nemocnice Strakonice, A.S.Strakonice, Czechia, 386 29|Achrafieh, Beirut, Lebanon|Tbilisi, Georgia, 0141 David Tatishvili Medical CenterTbilisi, Georgia, 0186|Berlin, Germany, 10318 Krankenhaus Waldfriede E.V.,Berlin, Germany, 14163 Universitaetsklinikum BonnBonn, Germany, 53127 Universitaetsklinikum Schleswig-HolsteinKiel, Germany, 24105 UniversitÃ¤tsklinikum Giessen Und Marburg GmbhMarburg, Germany, 35043|Bekescsaba, Hungary, 5600 Semmelweis Egyetem, Ii. Belgyogyaszati KlinikaBudapest, Hungary, 1088 Szent Janos Korhaz Es Eszak-Budai Egyesitett Korhazak[Active, Not Recruiting]Budapest, Hungary, 1125 Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz, Endoszkopos LaboratoriumGyula, Hungary, 5700 Clinfan Szolgaltato Kft.Szekszard, Hungary, 7100 Csolnoky Ferenc Korhaz Belgyogyaszati Centrum I. Belgyogyaszati OsztalyVeszprem, Hungary, 8200|Messina, Italy, 98125 Aou Policlinico Di ModenaModena, Italy, 41124 Azienda Ospedaliera Di PadovaPadova, Italy, 35128 Policlinico Universitario Campus Bio-MedicoRoma, Italy, 00128 Policlinico Gemelli/Complesso Integrato ColumbusRome, Italy, 00168 Korea, Republic Of, Korea Kyungpook National University HospitalDaegu, Korea, Korea, Republic Of, 41944 Korea, Republic Of Kyung Hee University HospitalSeoul, Korea, Republic Of, 02447 Kangbuk Samsung HospitalSeoul, Korea, Republic Of, 03181 Severance Hospital, Yonsei University Health SystemSeoul, Korea, Republic Of, 03722 The Catholic University Of Korea, Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591|Castellana Grotte, Bari, Italy, 70013|Brescia, Bs, Italy, 25123|Catanzaro, Cz, Italy, 88100|Monza, Mb, Italy, 20090|Rozzano, Milan, Italy, 20089|Rho, Milano, Italy, 20017|Dubai, United Arab Emirates, 22241 Emirates Specialty HospitalDubai, United Arab Emirates, Po Box 505240|Achrafieh, Lebanon American University Of Beirut Medical CenterBeirut, Lebanon Ain Wazein Medical VillageEl Chouf, Lebanon Centre Hospitalier Universitaire Notre Dame De SecoursJbeil, Lebanon Hammoud Hospital University Medical CenterSaida, Lebanon|Katowice, Poland, 40-659 Etg KielceKielce, Poland, 25-355 Indywidualna Specjalistyczna Praktyka Lekarska Maciej ZymlaKnurow, Poland, 44-190 Szpital W Knurowie Sp. Z O.O.Knurow, Poland, 44-190 Centrum Badan Klinicznych JciKrakow, Poland, 30-348 Marta Dagmara Banach Marta Banach Specjalistyczny Gabinet NeurologicznyKrakow, Poland, 30-539 Centrum Medyczne EvitaKrakow, Poland, 31-153 Szpital Specjalistyczny Im. Ludwika Rydygiera W Krakowie Sp. Z O.O.Krakow, Poland, 31-826 Centrum Medyczne Szpital Swietej Rodziny Sp Z O.O.Lodz, Poland, 90-302 Pracownia Endoskopii Centrum Medyczne Szpital Swietej Rodziny Sp Z O.O.Lodz, Poland, 90-302 Medical Magnus ClinicLodz, Poland, 90-552 Wojewodzki Szpital Specjalistyczny Im. Bieganskiego W LodziLodz, Poland, 91-347 Gastromed Sp. Z O.O.Lublin, Poland, 20-582 Ai Centrum Medyczne Sp. Z O.O. Sp.K.Poznan, Poland, 61-113 Korczowski Bartosz Gabinet LekarskiRzeszow, Poland, 35-302 Endoskopia Sp. Z O. O.Sopot, Poland, 81-756 Szpital Sredzki Serca Jezusowego Sp. Z O.O.Sroda Wielkopolska, Poland, 63-000 Ez-Med Sp. Z O.O. Sp.K.Swidnica, Poland, 58-100 Pracownia Endoskopii Szpital MswSzczecin, Poland, 70-001 Twoja Przychodnia Szczecinskie Centrum MedyczneSzczecin, Poland, 71-434 Gastromed Kopon, Zmudzinski I Wspolnicy Sp.J.Torun, Poland, 87-100 Centrum Zdrowia MdmWarszawa, Poland, 00-635 Centrum Diagnostyczno-Lecznicze Barska Sp. Z O. O.Wloclawek, Poland, 87-800 Melita Medical Sp. Z O.O.Wroclaw, Poland, 50-449 Centrum Gastrologiczno HepatologiczneWroclaw, Poland, 50-555 Planetmed Sp. Z.O.O.Wroclaw, Poland, 52-210 LexmedicaWroclaw, Poland, 53-114 Russian Federation, Sestroretsk Spb Sbih \"City Hospital #40 Of The Kurortnyi Region\"Saint-Petersburg, Sestroretsk, Russian Federation, 197706 Russian Federation Llc \"Alliance Biomedical-Ural Group\"Izhevsk, Russian Federation, 426061 Clinic Of Fsbei He Ksmu Moh RfKrasnodar, Russian Federation, 350072 Llc \"Olla-Med\"Moscow, Russian Federation, 105554 Sechenov University On The Base Of Institute Of Translational Medicine And BiotechnologyMoscow, Russian Federation, 119435 Limited Liability Company \"Medical Center Sibnovomed\"Novosibirsk, Russian Federation, 630005 Federal State Budgetary Scientific Institution \"Scientific Research Institute Of Physiology AndNovosibirsk, Russian Federation, 630117 Clinic At Fsbei He \"Omsk State Medical University\" Moh RfOmsk, Russian Federation, 644050 Llc \"New Clinic\"Pyatigorsk, Russian Federation, 357500 Limited Liability Company \"Riat\"Saint-Petersburg, Russian Federation, 195220 Saint-Petersburg State Budgetary Healthcare Institution \"City Hospital #26\"Saint-Petersburg, Russian Federation, 196247 Private Institution Educational Organization Of Higher EducationSamara, Russian Federation, 443011 Non-State Healthcare Institution 'Railway Clinical Hospital At Samara Station Of Open Joint StockSamara, Russian Federation, 443029 Saint-Petersburg State Budgetary Healthcare Institution \"City Clinical Hospital Of The RighteousSt. Petersburg, Russian Federation, 197706|Tychy, Silesia, Poland, 43-100|Riyadh, Saudi Arabia, 11426 King Khalid University HospitalRiyadh, Saudi Arabia, 11472|Zemun, Beograd, Serbia, 11080|Beograd, Serbia, 11000 Vojnomedicinska Akademija, Klinika Za Gastroenterologiju I HepatologijuBeograd, Serbia, 11000 Kbc \"Dr Dragisa Misovic-Dedinje\"Beograd, Serbia, 11040 Klinicko Bolnicki Centar Zemun, Klinika Za Internu Medicinu,Zemun, Beograd, Serbia, 11080|Beograd, Srbija, Serbia, 11000 Klinicki Centar KragujevacKragujevac, Srbija, Serbia, 34000 Klinicki Centar NisNis, Srbija, Serbia, 18000 Opsta Bolnica SuboticaSubotica, Srbija, Serbia, 24000 Opsta Bolnica \"Djordje Joanovic\", Odeljenje Interno, Odsek GastroenterologijaZrenjanin, Srbija, Serbia, 23000|Banska Bystrica, Slovakia, 975 17 Breznianske Centrum Gastroenterologie S.R.O.Brezno, Slovakia, 97701 Km Management Spol. S.R.O.Nitra, Slovakia, 949 01 Accout Center S.R.O. Gastroenterologicka AmbulanciaSahy, Slovakia, 936 01 Endomed, S.R.O.Vranov Nad Toplou, Slovakia, 093 01|Lenasia, Gauteng, South Africa, 1827 Wits Clinical Research Trial SiteParktown, Gauteng, South Africa, 2193 Wits Clinical Reasearch - Wits Bara Clinical Trial SiteSoweto, Gauteng, South Africa, 2013|Claremont, Western Cape, South Africa, 7708|Santander, Cantabria, Spain, 39008|Madrid, Spain, 28034 Hospital Universitario Virgen Del RocioSevilla, Spain, 41013 Hospital Universitari I Politecnic La FeValencia, Spain, 46026|Bern, Switzerland, Ch - 3012 UniversitÃ¤tsspital ZÃ¼richZÃ¼rich, Switzerland, Ch-8091|Tunis, Tunisia, 1007 Habib Thameur HospitalTunis, Tunisia, 1008|Ankara, Turkey, 06100 Ankara Universitesi Tip Fakultesi, Ibn-I Sina HastanesiAnkara, Turkey, 06100 Hacettepe Universitesi Tip FakultesiAnkara, Turkey, 06230 Bezmialem Vakif Universitesi Tip Fakultesi HastanesiIstanbul, Turkey, 34093 Istanbul Universitesi Cerrahpasa Tip FacultesiIstanbul, Turkey, 34098 Istanbul Universitesi Cerrahpasa Tip FakultesiIstanbul, Turkey, 34098 Erciyes Universitesi Tip FakultesiKayseri, Turkey, 38039 Kocaeli Universitesi Tip FakultesiKocaeli, Turkey, 41380 Mersin Universitesi Tip Fakultesi Hastanesi, Ic HastaliklariMersin, Turkey, 33110 Mersin Universitesi Tip Fakultesi HastanesiMersin, Turkey, 33110 Karadeniz Teknik Universitesi Tip Fakultesi, Ic HastaliklariTrabzon, Turkey, 61080 Karadeniz Teknik Universitesi Tip FakultesiTrabzon, Turkey, 61080 Bulent Ecevit Universitesi Tip FakultesiZonguldak, Turkey, 67600|Chernivtsi, Ukraine, 58001 Regional Municipal Institution \"Chernivtsi Regional Clinical Hospital\", Surgery DepartmentChernivtsi, Ukraine, 58001 Municipal Healthcare Institution Kharkiv City Clinical Hospital #2 N.A. Prof. O.O. ShalimovKharkiv, Ukraine, 61037 Private Enterprise Of Private Manufacturing Company \"Acinus\", Medical And Diagnostic CenterKropyvnytskyi, Ukraine, 25006 Kyiv Municipal Clinical Hospital #18, Proctology DepartmentKyiv, Ukraine, 01030 Medical Center \"Universal Clinic Oberig\" Of \"Kapital\" Llc, Gastro CenterKyiv, Ukraine, 03680 Lviv Clinical Hospital On Railway Transport Of Health Care Center Branch Of Pjsc Ukrainian RailwayLviv, Ukraine, 79007 Vinnytsia City Clinical Hospital No.1Vinnytsia, Ukraine, 21000 Private Small-Scale Enterprise Medical Center \"Pulse\"Vinnytsia, Ukraine, 21001 Vinnytsia Regional Clinical Hospital For War VeteransVinnytsia, Ukraine, 21005 Vinnytsia Regional Clinical Hospital N.A. M.I.PyrohovVinnytsia, Ukraine, 21018|Abu Dhabi, United Arab Emirates, 112412 Al|Dothan, Alabama, United States, 36301 Gut P.C., Dba Digestive Health Specialists Of The SoutheastDothan, Alabama, United States, 36305|Beverly Hills, California, United States, 90210 Long Beach Clinical Trial Services, Inc.Long Beach, California, United States, 90806 Entertainment Medical GroupLos Angeles, California, United States, 90036 Gastrointestinal Biosciences Clinical Trials, LlcLos Angeles, California, United States, 90067 Alliance Clinical Research, LlcPoway, California, United States, 92064|Colorado Springs, Colorado, United States, 80903|Clearwater, Florida, United States, 33756-3839 West Coast Endoscopy CenterClearwater, Florida, United States, 33756 Gastro FloridaClearwater, Florida, United States, 33762 Uf Health Jacksonville - Gastroenterology EmersonJacksonville, Florida, United States, 32207 Uf Health Jacksonville - Faculty ClinicJacksonville, Florida, United States, 32209 University Of Miami Clinical Research BuildingMiami, Florida, United States, 33136 University Of Miami Crohn'S And Colitis CenterMiami, Florida, United States, 33136 University Of Miami Hospital And ClinicsMiami, Florida, United States, 33136 University Of Miami HospitalMiami, Florida, United States, 33136 Millenia Surgery CenterOrlando, Florida, United States, 32811 Hmd Research LlcOrlando, Florida, United States, 32819|Boise, Idaho, United States, 83706 Idaho Gastroenterology Associates (Endoscopy Center)Meridian, Idaho, United States, 83642|Shawnee Mission, Kansas, United States, 66217|Houma, Louisiana, United States, 70360 Gulf Coast Surgical CenterHouma, Louisiana, United States, 70360 The Hearing Center (Audiology)Houma, Louisiana, United States, 70360|Chevy Chase, Maryland, United States, 20815 Mgg Group Co., Inc., Chevy Chase Clinical ResearchChevy Chase, Maryland, United States, 20815 Capitol ResearchRockville, Maryland, United States, 20850|Boston, Massachusetts, United States, 02115 Mass Eye And Ear, LongwoodBoston, Massachusetts, United States, 02115 Brigham And Women'S HospitalBoston, Massachusetts, United States, 02215 Brigham And Women'S HospitalChestnut Hill, Massachusetts, United States, 02467 Umass Memorial Medical CenterWorcester, Massachusetts, United States, 01655 University Of Massachusetts Medical SchoolWorcester, Massachusetts, United States, 01655|Caro, Michigan, United States, 48723 Clinical Research Institute Of Michigan, LlcChesterfield, Michigan, United States, 48047 Eastside Endoscopy CenterMacomb, Michigan, United States, 48044 Eastside Endoscopy CenterSaint Clair Shores, Michigan, United States, 48081|Ocean Springs, Mississippi, United States, 39564|New York, New York, United States, 10021 New York Presbyterian Hospital - Weill Cornell Medical College (Colonoscopy)New York, New York, United States, 10065 New York Presbyterian Hospital - Weill Cornell Medical College Investigational PharmacyNew York, New York, United States, 10065 Weill Cornell Medical College - New York Presbyterian Hospital (Endoscopy Suite)New York, New York, United States, 10065 Weill Cornell Medical College - New York Presbyterian HospitalNew York, New York, United States, 10065 Digiovanna Institute For Medical Education And ResearchNorth Massapequa, New York, United States, 11758-1853|Chapel Hill, North Carolina, United States, 27514 Unc Hospitals Endoscopy Center At MeadowmontChapel Hill, North Carolina, United States, 27517 University Of North Carolina At Chapel HillChapel Hill, North Carolina, United States, 27599 Gastroenterology Associates Of The Piedmont, PaWinston-Salem, North Carolina, United States, 27103 Pmg Research Of Winston-Salem, LlcWinston-Salem, North Carolina, United States, 27103|Oklahoma City, Oklahoma, United States, 73112|Kingsport, Tennessee, United States, 37660 Holston Valley Surgery CenterKingsport, Tennessee, United States, 37660 Vanderbilt University Medical CenterNashville, Tennessee, United States, 37212-1375 Vanderbilt University Medical CenterNashville, Tennessee, United States, 37212-1610 Vanderbilt University Medical Center - Gi Endoscopy LabNashville, Tennessee, United States, 37232-5543 Vanderbilt University Medical CenterNashville, Tennessee, United States, 37232-7610 Vanderbilt University Medical Center - Gi Research RegulatoryNashville, Tennessee, United States, 37232|Arlington, Texas, United States, 76012 Envision Imaging (Cxr)Arlington, Texas, United States, 76012 Texas Clinical Research Institiute, LlcArlington, Texas, United States, 76012 First Street HospitalBellaire, Texas, United States, 77401 Hrmd ResearchDallas, Texas, United States, 75240 Pearland Surgery CenterHouston, Texas, United States, 77047 Gulf Coast Research Group, LlcHouston, Texas, United States, 77098 Lonestar Endoscopy, LlpSouthlake, Texas, United States, 76092 Texas Digestive Disease ConsultantsSouthlake, Texas, United States, 76092|Fairfax, Virginia, United States, 22031","Alabama|California|Colorado|Florida|Idaho|Kansas|Louisiana|Maryland|Massachusetts|Michigan|Mississippi|New York|North Carolina|Oklahoma|Tennessee|Texas|Virginia","Australia|Austria|Belgium|Bosnia And Herzegovina|Canada|Croatia|Czechia|France|Georgia|Germany|Hungary|Italy|Kuwait|Lebanon|Poland|Saudi Arabia|Serbia|Slovakia|South Africa|Spain|Switzerland|Tunisia|Turkey|Ukraine|United Arab Emirates|United States","New South Wales Concord Repatriation General Hospital|Queensland Mater Misericordiae Ltd|Saint John Of God Health Care Inc.|Victoria Ballarat Base Hospital|Akh Wien Universitaetsklinik Fuer Innere Medizin Iii|University Hospital Brussels|Javna Zdravstvena Ustanova Univerzitetski Klinicki Centar Republike Srpske,|Manitoba Winnipeg Regional Health Authority - Health Sciences Centre, Winnipeg|Ontario HÃ´pital Montfort|Quebec Ciusss De L'Est-De-L'Ile-De-Montreal Installation Hopital Maisonneuve-Rosemont|Hrvatska Klinicki Bolnicki Centar Sestre Milosrdnice|Klinicki Bolnicki Centar Rijeka, Odjel Za Gastroenterologiju|Lekarna Altea|Hospital|The First University Clinic Of Tsmu|Paian Med Research Gmbh|Bekes Megyei Kozponti Korhaz, Rethy Pal Tagkorhaz|A.O.U. Policlinico G. Martino|Bari Irccs Saverio De Bellis|Bs A.O.Spedali Civili|Cz Univ. \"Magna Graecia\" Di Catanzaro|Mb Asst Monza|Milan Istituto Clinico Humanitas Irccs - Ibd Center|Milano Asst Rhodense - Ospedale Di Circolo Di Rho|Hospital - Dubai|Saint George Hospital University Medical Center|Niepubliczny Zaklad Opieki Zdrowotnej All-Medicus|Silesia H-T. Centrum Medyczne-Endoterapia|King Abdulaziz Medical City|Beograd Klinicko Bolnicki Centar \"Bezanijska Kosa\"|Klinicko Bolnicki Centar Zvezdara, Klinika Za Interne Bolesti,|Srbija Klinicki Centar Srbije, Klinika Za Gastroenterohepatologiju|Fakultna Nemocnica S Poliklinikou F.D. Roosevelta Banska Bystrica|, Gauteng Lenasia Clinical Trial Centre|, Western Cape Dr Wright Private Practice|Cantabria Hospital Universitario Marques De Valdecilla|Hospital Universitario Ramon Y Cajal|Verein Ibd Study Group|La Rabta Hospital|Ankara Universitesi Tip Fakultesi, Ibn-I Sina Hastanesi, Ic Hastaliklari Anabilim Dali,|Regional Municipal Institution \"Chernivtsi Regional Clinical Hospital\", Gastroenterology Department,|Cleveland Clinica Abu Dhabi, Department Of Gastroenterology And Hepatology|Dothan Surgery Center|Brighton Surgical Center|Front Range Endoscopy Center|Gastro Florida|Treasure Valley Medical Research|Westglen Gastrointestinal Consultants, P.A.|Cronola, Llc|Chevy Chase Endoscopy Center|Brigham And Women's Hospital|Caro Health Plaza|Digestive Health Center|Weill Cornell Medical College (Clinical Site)|Unc Hospitals|Digestive Disease Specialists, Inc.|Holston Medical Group|Cross Timbers Surgery Center L.P. (Colonoscopy)|Verity Research, Inc.",{"$nulls":3},"Pfizer CT.gov Call Center","2020-01-15","2020-05-25T16:36:05.724","2020-05-26T17:10:42.972","NCT03395184"]
["5ecbf3f6feab101b1553083d","NCT03395184","2020-02-06","Pfizer","PFE","Recruiting","Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PFâ€‘06700841 In Subjects With Moderate To Severe Crohn's Disease","Brepocitinib|Pf-06651600","JAK1 Inhibitor|TYK2 Inhibitor|JAK1 Inhibitor|JAK3 Inhibitor","Yes","['Brepocitinib', 'Pf-06651600']","Yes","['TYK2 Inhibitor', 'JAK3 Inhibitor']","Phase 2",2,250,"Anticipated","2018-02-02","2022-11-30","DAS","Disease Activity Score",{"$nulls":3},"The objectives of this study are to evaluate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-06651600 (200 mg for 8 weeks followed by 50 mg for 4 weeks) dosed once daily and PF-06700841 (60 mg for 12 weeks) dosed once daily during an induction period of 12 weeks, followed by an open label extension period at doses of 50 mg and 30 mg of PF 06651600 and PF 06700841, respectively, for 52 weeks.",null,"A PHASE 2A, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ORAL PF-06651600 AND PF-06700841 AS INDUCTION AND OPEN LABEL EXTENSION TREATMENT IN SUBJECTS WITH MODERATE TO SEVERE CROHN'S DISEASE","B7981007","Crohn's Disease","Crohn Disease","Gastrointestinal Diseases","Gastrointestinal","Experimental","PF-06700841 or placebo|PF-06651600 or placebo",null,"Drug","Placebo PF-06700841|PF-06700841|Placebo PF-06651600|PF-06651600","12 weeks, followed by PF-06700841, 30 mg QD for 52 weeks.|60 mg QD for 12 weeks followed by 30 mg QD for up to 52 weeks|12 weeks, followed by PF-06651600, 50 mg QD for 52 weeks|200 mg QD for 8 weeks, followed by 50 mg QD up to 56 weeks",null,"PF-06700841 or placebo|PF-06651600 or placebo","\n\n 1. Male and/or female subjects 18 years to 75 years of age\n 2. Documented diagnosis of ileal, ileocolonic, or colonic CD with a minimum disease duration of 3 months, as determined by endoscopic and histopathology assessment.\n 3. Endoscopic confirmation of active disease with total SES CD total score of at least 7. For isolated ileal disease, SES CD total score should be at least 4.\n 4. An average daily liquid/soft stool frequency (SF) greater than or equal to 2.5 or daily abdominal pain (AP) greater than or equal to 2.0.\n 5. Must have inadequate response to, loss of response to, or intolerance to at least one conventional therapy for CD:â€¢Steroids; Immunosuppressants (azathioprine [AZA], 6 MP, or methotrexate [MTX]); Anti TNF inhibitors (infliximab, adalimumab,certolizumab); Anti integrin inhibitors (eg, vedolizumab); Anti IL 12/23 inhibitor (ustekinumab).\n    \n    \n 6. Subjects currently receiving the following treatment for CD are eligible providing they have been on stable doses as described below: * Oral corticosteroids (prednisone or equivalent up to 25 mg/day; budesonide up to 9 mg/day). Stable dose for at least 2 weeks prior to baseline. If oral corticosteroids have been recently discontinued, they must have been stopped at least 2 weeks prior to baseline. Decreases in steroid use due to AEs are allowed.\n     * Oral 5 ASA or sulfasalazine are allowed providing that the dose is stable for at least 4 weeks prior to baseline.\n     * Crohn's disease related antibiotics are allowed providing that the dose is stable for at least 4 weeks prior to baseline. If antibiotics are stopped prior to baseline, they must be discontinued at least 4 days prior to baseline.\n    \n    \n\n","\n\n 1.  Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, diverticular disease, ulcerative colitis (UC), or clinical findings suggestive of UC.\n 2.  Presence of active (draining) fistulae or intra abdominal or perineal abscesses.\n 3.  Strictures with obstructive symptoms.\n 4.  Short bowel syndrome.\n 5.  History of bowel perforation requiring surgical intervention within the past 12 months.\n 6.  Previous bowel surgery resulting in an existing stoma. Subjects who have a j pouch are excluded, as a j pouch can result in a stoma.\n 7.  History of bowel surgery within 6 months prior to baseline.\n 8.  Subjects displaying clinical signs of fulminant colitis or toxic megacolon.\n 9.  Subjects with primary sclerosing cholangitis.\n 10. Subjects with evidence of colonic adenomas, dysplasia or neoplasia.\n 11. Abnormal findings on the chest x ray film such as presence of tuberculosis (TB), general infections, heart failure, or malignancy.\n 12. Any history of either untreated or inadequately treated latent or active TB infection, current treatment for active or latent TB infection or evidence of currently active TB by chest x ray, residing with or frequent close contact with individual(s) with active TB.\n 13. Subjects receiving the following therapies within the time period described below or expected to receive any of these therapies during the study period: 1.  >9 mg/day of oral budesonide or >25 mg/day of prednisone or equivalent oral systemic corticosteroid dose within 2 weeks prior to baseline.\n      2.  IV, IM (parenteral), or topical (rectal) treatment of 5 ASA or corticosteroid enemas/suppositories within 2 weeks prior to baseline.\n      3.  Azathioprine, 6 mercaptopurine, or methotrexate within 2 weeks prior to baseline.\n      4.  Anti TNF inhibitors (or biosimilars thereof) as described below: * Infliximab within 8 weeks prior to baseline;\n           * Adalimumab within 8 weeks prior to baseline;\n           * Certolizumab within 8 weeks prior to baseline;\n          \n          \n      5.  Anti integrin inhibitors (eg, vedolizumab) within 8 weeks prior to baseline.\n      6.  Ustekinumab within 8 weeks prior to baseline.\n      7.  Interferon therapy within 8 weeks prior to baseline.\n      8.  Subjects with prior treatment with lymphocyte depleting agents/therapies within 1 year prior to baseline (eg, CamPath[alemtuzumab], alkylating agents [eg, cyclophosphamide or chlorambucil], total lymphoid irradiation, etc).\n      9.  Subjects who have received rituximab or other selective B lymphocyte depleting agents within 1 year prior to baseline.\n      10. Subjects previously receiving leukocyte apheresis, including selective lymphocyte, monocyte, or granulocyte apheresis, or plasma exchange within 6 months prior to baseline.\n      11. Other marketed immunosuppressants or biologics with immunomodulatory properties within 3 months prior to baseline.\n      12. Subjects who have received other JAK inhibitors within 3 months prior to baseline.\n      13. Subjects who have not responded to or have been intolerant of other JAK inhibitors.\n      14. Other investigational procedures(s) or product(s), such as immunosuppressants used in transplantation (eg, mycophenolate mofetil, cyclosporine, rapamycin, or tacrolimus) or live (attenuated) vaccine within 30 days prior to baseline.","TNF","tumor necrosis factor","Protein","Lung, Breast, Ovary","Actual","2018-01-10","Actual","Anticipated","2022-11-30","Anticipated","2020-02-01","2017-12-05","2018-01-03","2020-02-04","Yes",null,"Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years","75 Years","All",null,"No","Yes\nPfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",null,"URL: https://pmiform.com/clinical-trial-info-request?StudyID=B7981007 [https://pmiform.com/clinical-trial-info-request?StudyID=B7981007] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To obtain contact information for a study center near you, click here.",null,"Yes","No",{"$nulls":17},"2017-003359-43|PIZZICATO","EudraCT Number|Alias Study Number","Proportion of subjects achieving clinically meaningful endoscopic improvement (reduction of more than or equal to 3 points from baseline in Simplified Endoscopic Activity Score for Crohn's Disease (SES-CD) at Week 12|Number of subjects with adverse events|Number of subjects with serious adverse events|Number of subjects with electrocardiogram findings of potential clinical importance|Number of subjects with laboratory tests findings of potential clinical importance|Number of subjects withdrawal due to adverse events|Number of subjects with vital signs findings of potential clinical importance","12 weeks|Baseline of extension period (Week 12) to week 68",null,"Number of participants with potentially clinically important serious infections findings|Mean change from baseline in SES-CD score at Week 12.|Proportion of subjects achieving SES-CD 25 and SES-CD 50 at Week 12.|Proportion of subjects achieving endoscopic remission (SES-CD less than or equal to 2) at Week 12.|Proportion of subjects achieving mucosal healing at Week 12.|Number of subjects with adverse events|Number of subjects with serious adverse events|Number of subjects with electrocardiogram findings of potential clinical importance.|Number of subjects withdrawal due to adverse events|Number of subjects with vital signs findings of potential clinical importance.|Number of subjects with laboratory tests findings of potential clinical importance.|Proportion of subjects achieving SES CD 25 and SES CD 50 at Week 64 among subjects who achieved SES CD 25 and SES CD 50 at week 12 respectively.|Proportion of subjects achieving clinically meaningful endoscopic improvement (CMEI response) at week 64 among subjects who achieved CMEI response at Week 12.","64 weeks|Baseline, week 12|Number of subjects achieving SES-CD 25 and SES-CD 50 at Week 12.|Number of subjects achieving endoscopic remission (SES-CD less than or equal to 2) at Week 12.|Number of subjects achieving mucosal healing at Week 12.|Number of participants with reported adverse events|Number of participants with reported serious adverse events|Number of participants with potentially clinically important electrocardiogram findings.|Number of subjects withdrawal due to adverse events.|Number of participants with potentially clinically important vital signs findings.|Number of participants with potentially clinically important laboratory findings.|Number of subjects achieving SES-CD 25 and SES-CD 50 at Week 64 among subjects who achieved SES CD 25 and SES CD 50 at week 12|Number of subject achieving clinically meaningful endoscopic improvement (CMEI response) at week 64 among subjects who achieved CMEI response at week 12.","Baseline, week 12|Week 12|Baseline of induction period to week 12|week 64","ClinicalTrials.gov_Inquiries@pfizer.com","Pfizer CT.gov Call Center","1-800-718-1021","Concord, New South Wales, Australia, 2139|South Brisbane, Queensland, Australia, 4101|Subiaco, Western|Ballarat, Victoria, Australia, 3350|Wien, Austria, 1090|Jette, Belgium, 1090 University Hospitals LeuvenLeuven, Belgium, 3000 Chc - Saint-JosephLiÃ¨ge, Belgium, 4000|Banja Luka, Bosnia And Herzegovina, 78000 Sveucilisna Klinicka Bolnica Mostar,Mostar, Bosnia And Herzegovina, 88000|Winnipeg, Manitoba, Canada, R3A 1R9|Ottawa, Ontario, Canada, K1K 0T2|Montreal, Quebec, Canada, H1T 2M4|Zagreb, Hrvatska, Croatia, 10000|Rijeka, Croatia, 51000 Klinicki Bolnicki Centar Split, Zavod Za GastroenterologijuSplit, Croatia, 21000 Opca Bolnica Zadar, Odjel Za GastroenterologijuZadar, Croatia, 23000 Klinicka Bolnica Dubrava ZagrebZagreb, Croatia, 10000 Klinicki Bolnicki Centar Zagreb, Zavod Za Gastroenterologiju I HepatologijuZagreb, Croatia, 10000|Bilina, Czechia, 41801 Nemocnice Horovice, A.S.Horovice, Czechia, 268 31 Hepato-Gastroenterologie Hk S.R.O.Hradec Kralove, Czechia, 500 12 Medialpharma S.R.O.Hradec Kralove, Czechia, 500 12 Gastroenterologicka Ambulance A EndoskopieMost, Czechia, 43401 Vseobecna Fakultni NemocnicePraha 2, Czechia, 128 08 VÅ¡eobecnÃ¡ FakultnÃ­ Nemocnice V PrazePraha 2, Czechia, 128 08 Lekarna Sv. AnnaPraha 3, Czechia, 130 00 Egk S.R.O. - Sanatorium Sv. AnnyPraha 3, Czechia, 13000 Fakultni Nemocnice V MotolePraha 5, Czechia, 150 06 FakultnÃ­ Nemocnice V MotolePraha 5, Czechia, 150 06 Nemocnice Strakonice, A.S., Interni OddeleniStrakonice, Czechia, 386 01 Nemocnice Strakonice, A.S.Strakonice, Czechia, 386 29|Achrafieh, Beirut, Lebanon|Tbilisi, Georgia, 0141 Institute Of Clinical Cardiology, Ltd.Tbilisi, Georgia, 0159 David Tatishvili Medical CenterTbilisi, Georgia, 0186|Berlin, Germany, 10318 Krankenhaus Waldfriede E.V.,Berlin, Germany, 14163 Universitaetsklinikum BonnBonn, Germany, 53127 Universitaetsklinikum Schleswig-HolsteinKiel, Germany, 24105 UniversitÃ¤tsklinikum Giessen Und Marburg GmbhMarburg, Germany, 35043|Bekescsaba, Hungary, 5600 Semmelweis Egyetem, Ii. Belgyogyaszati KlinikaBudapest, Hungary, 1088 Szent Janos Korhaz Es Eszak-Budai Egyesitett Korhazak[Active, Not Recruiting]Budapest, Hungary, 1125 Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz, Endoszkopos LaboratoriumGyula, Hungary, 5700 Clinfan Szolgaltato Kft.Szekszard, Hungary, 7100 Csolnoky Ferenc Korhaz Belgyogyaszati Centrum I. Belgyogyaszati OsztalyVeszprem, Hungary, 8200|Messina, Italy, 98125 Aou Policlinico Di ModenaModena, Italy, 41124 Azienda Ospedaliera Di PadovaPadova, Italy, 35128 Policlinico Universitario Campus Bio-MedicoRoma, Italy, 00128 Policlinico Gemelli/Complesso Integrato ColumbusRome, Italy, 00168 Korea, Republic Of, Korea Kyungpook National University HospitalDaegu, Korea, Korea, Republic Of, 41944 Korea, Republic Of Kyung Hee University HospitalSeoul, Korea, Republic Of, 02447 Kangbuk Samsung HospitalSeoul, Korea, Republic Of, 03181 Severance Hospital, Yonsei University Health SystemSeoul, Korea, Republic Of, 03722 The Catholic University Of Korea, Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591|Castellana Grotte, Bari, Italy, 70013|Brescia, Bs, Italy, 25123|Catanzaro, Cz, Italy, 88100|Monza, Mb, Italy, 20090|Rozzano, Milan, Italy, 20089|Rho, Milano, Italy, 20017|Dubai, United Arab Emirates, 22241 Emirates Specialty HospitalDubai, United Arab Emirates, Po Box 505240|Achrafieh, Lebanon American University Of Beirut Medical CenterBeirut, Lebanon Ain Wazein Medical VillageEl Chouf, Lebanon Centre Hospitalier Universitaire Notre Dame De SecoursJbeil, Lebanon Hammoud Hospital University Medical CenterSaida, Lebanon|Katowice, Poland, 40-659 Etg KielceKielce, Poland, 25-355 Indywidualna Specjalistyczna Praktyka Lekarska Maciej ZymlaKnurow, Poland, 44-190 Szpital W Knurowie Sp. Z O.O.Knurow, Poland, 44-190 Centrum Badan Klinicznych JciKrakow, Poland, 30-348 Marta Dagmara Banach Marta Banach Specjalistyczny Gabinet NeurologicznyKrakow, Poland, 30-539 Centrum Medyczne EvitaKrakow, Poland, 31-153 Szpital Specjalistyczny Im. Ludwika Rydygiera W Krakowie Sp. Z O.O.Krakow, Poland, 31-826 Centrum Medyczne Szpital Swietej Rodziny Sp Z O.O.Lodz, Poland, 90-302 Pracownia Endoskopii Centrum Medyczne Szpital Swietej Rodziny Sp Z O.O.Lodz, Poland, 90-302 Medical Magnus ClinicLodz, Poland, 90-552 Wojewodzki Szpital Specjalistyczny Im. Bieganskiego W LodziLodz, Poland, 91-347 Gastromed Sp. Z O.O.Lublin, Poland, 20-582 Ai Centrum Medyczne Sp. Z O.O. Sp.K.Poznan, Poland, 61-113 Korczowski Bartosz Gabinet LekarskiRzeszow, Poland, 35-302 Endoskopia Sp. Z O. O.Sopot, Poland, 81-756 Szpital Sredzki Serca Jezusowego Sp. Z O.O.Sroda Wielkopolska, Poland, 63-000 Ez-Med Sp. Z O.O. Sp.K.Swidnica, Poland, 58-100 Pracownia Endoskopii Szpital MswSzczecin, Poland, 70-001 Twoja Przychodnia Szczecinskie Centrum MedyczneSzczecin, Poland, 71-434 Gastromed Kopon, Zmudzinski I Wspolnicy Sp.J.Torun, Poland, 87-100 Centrum Zdrowia MdmWarszawa, Poland, 00-635 Wip Warsaw Ibd Point Profesor KierkusWarszawa, Poland, 00-728 Endoterapia Pfg Sp. Z O.O.Warszawa, Poland, 02-653 Centrum Diagnostyczno-Lecznicze Barska Sp. Z O. O.Wloclawek, Poland, 87-800 Melita Medical Sp. Z O.O.Wroclaw, Poland, 50-449 Centrum Gastrologiczno HepatologiczneWroclaw, Poland, 50-555 Planetmed Sp. Z.O.O.Wroclaw, Poland, 52-210 LexmedicaWroclaw, Poland, 53-114 Russian Federation, Sestroretsk Spb Sbih \"City Hospital #40 Of The Kurortnyi Region\"Saint-Petersburg, Sestroretsk, Russian Federation, 197706 Russian Federation Llc \"Alliance Biomedical-Ural Group\"Izhevsk, Russian Federation, 426061 Clinic Of Fsbei He Ksmu Moh RfKrasnodar, Russian Federation, 350072 Llc \"Olla-Med\"Moscow, Russian Federation, 105554 Sechenov University On The Base Of Institute Of Translational Medicine And BiotechnologyMoscow, Russian Federation, 119435 Limited Liability Company \"Medical Center Sibnovomed\"Novosibirsk, Russian Federation, 630005 Federal State Budgetary Scientific Institution \"Scientific Research Institute Of Physiology AndNovosibirsk, Russian Federation, 630117 Clinic At Fsbei He \"Omsk State Medical University\" Moh RfOmsk, Russian Federation, 644050 Llc \"New Clinic\"Pyatigorsk, Russian Federation, 357500 Limited Liability Company \"Riat\"Saint-Petersburg, Russian Federation, 195220 Saint-Petersburg State Budgetary Healthcare Institution \"City Hospital #26\"Saint-Petersburg, Russian Federation, 196247 Private Institution Educational Organization Of Higher EducationSamara, Russian Federation, 443011 Non-State Healthcare Institution 'Railway Clinical Hospital At Samara Station Of Open Joint StockSamara, Russian Federation, 443029 Saint-Petersburg State Budgetary Healthcare Institution \"City Clinical Hospital Of The RighteousSt. Petersburg, Russian Federation, 197706|Tychy, Silesia, Poland, 43-100|Riyadh, Saudi Arabia, 11426 King Khalid University HospitalRiyadh, Saudi Arabia, 11472|Zemun, Beograd, Serbia, 11080|Beograd, Serbia, 11000 Vojnomedicinska Akademija, Klinika Za Gastroenterologiju I HepatologijuBeograd, Serbia, 11000 Kbc \"Dr Dragisa Misovic-Dedinje\"Beograd, Serbia, 11040 Klinicko Bolnicki Centar Zemun, Klinika Za Internu Medicinu,Zemun, Beograd, Serbia, 11080|Beograd, Srbija, Serbia, 11000 Klinicki Centar KragujevacKragujevac, Srbija, Serbia, 34000 Klinicki Centar NisNis, Srbija, Serbia, 18000 Opsta Bolnica SuboticaSubotica, Srbija, Serbia, 24000 Opsta Bolnica \"Djordje Joanovic\", Odeljenje Interno, Odsek GastroenterologijaZrenjanin, Srbija, Serbia, 23000|Banska Bystrica, Slovakia, 975 17 Breznianske Centrum Gastroenterologie S.R.O.Brezno, Slovakia, 97701 Km Management Spol. S.R.O.Nitra, Slovakia, 949 01 Accout Center S.R.O. Gastroenterologicka AmbulanciaSahy, Slovakia, 936 01 Endomed, S.R.O.Vranov Nad Toplou, Slovakia, 093 01|Lenasia, Gauteng, South Africa, 1827 Wits Clinical Research Trial SiteParktown, Gauteng, South Africa, 2193 Wits Clinical Reasearch - Wits Bara Clinical Trial SiteSoweto, Gauteng, South Africa, 2013|Claremont, Western Cape, South Africa, 7708|Santander, Cantabria, Spain, 39008|Madrid, Spain, 28034 Hospital Universitario Virgen Del RocioSevilla, Spain, 41013 Hospital Universitari I Politecnic La FeValencia, Spain, 46026|Bern, Switzerland, Ch - 3012 UniversitÃ¤tsspital ZÃ¼richZÃ¼rich, Switzerland, Ch-8091|Tunis, Tunisia, 1007 Habib Thameur HospitalTunis, Tunisia, 1008|Ankara, Turkey, 06100 Ankara Universitesi Tip Fakultesi, Ibn-I Sina HastanesiAnkara, Turkey, 06100 Hacettepe Universitesi Tip FakultesiAnkara, Turkey, 06230 Bezmialem Vakif Universitesi Tip Fakultesi HastanesiIstanbul, Turkey, 34093 Istanbul Universitesi Cerrahpasa Tip FacultesiIstanbul, Turkey, 34098 Istanbul Universitesi Cerrahpasa Tip FakultesiIstanbul, Turkey, 34098 Erciyes Universitesi Tip FakultesiKayseri, Turkey, 38039 Kocaeli Universitesi Tip FakultesiKocaeli, Turkey, 41380 Mersin Universitesi Tip Fakultesi Hastanesi, Ic HastaliklariMersin, Turkey, 33110 Mersin Universitesi Tip Fakultesi HastanesiMersin, Turkey, 33110 Karadeniz Teknik Universitesi Tip Fakultesi, Ic HastaliklariTrabzon, Turkey, 61080 Karadeniz Teknik Universitesi Tip FakultesiTrabzon, Turkey, 61080 Bulent Ecevit Universitesi Tip FakultesiZonguldak, Turkey, 67600|Chernivtsi, Ukraine, 58001 Regional Municipal Institution \"Chernivtsi Regional Clinical Hospital\", Surgery DepartmentChernivtsi, Ukraine, 58001 Municipal Healthcare Institution Kharkiv City Clinical Hospital #2 N.A. Prof. O.O. ShalimovKharkiv, Ukraine, 61037 Private Enterprise Of Private Manufacturing Company \"Acinus\", Medical And Diagnostic CenterKropyvnytskyi, Ukraine, 25006 Kyiv Municipal Clinical Hospital #18, Proctology DepartmentKyiv, Ukraine, 01030 Medical Center \"Universal Clinic Oberig\" Of \"Kapital\" Llc, Gastro CenterKyiv, Ukraine, 03680 Lviv Clinical Hospital On Railway Transport Of Health Care Center Branch Of Pjsc Ukrainian RailwayLviv, Ukraine, 79007 Vinnytsia City Clinical Hospital No.1Vinnytsia, Ukraine, 21000 Private Small-Scale Enterprise Medical Center \"Pulse\"Vinnytsia, Ukraine, 21001 Vinnytsia Regional Clinical Hospital For War VeteransVinnytsia, Ukraine, 21005 Vinnytsia Regional Clinical Hospital N.A. M.I.PyrohovVinnytsia, Ukraine, 21018|Abu Dhabi, United Arab Emirates, 112412 Al|Dothan, Alabama, United States, 36301 Gut P.C., Dba Digestive Health Specialists Of The SoutheastDothan, Alabama, United States, 36305|Beverly Hills, California, United States, 90210 Long Beach Clinical Trial Services, Inc.Long Beach, California, United States, 90806 Entertainment Medical GroupLos Angeles, California, United States, 90036 Gastrointestinal Biosciences Clinical Trials, LlcLos Angeles, California, United States, 90067 Alliance Clinical Research, LlcPoway, California, United States, 92064|Colorado Springs, Colorado, United States, 80903 Peak Gastroenterology AssociatesColorado Springs, Colorado, United States, 80907|Clearwater, Florida, United States, 33756-3839 West Coast Endoscopy CenterClearwater, Florida, United States, 33756 Gastro FloridaClearwater, Florida, United States, 33762 Uf Health Jacksonville - Gastroenterology EmersonJacksonville, Florida, United States, 32207 Uf Health Jacksonville - Faculty ClinicJacksonville, Florida, United States, 32209 University Of Miami Clinical Research BuildingMiami, Florida, United States, 33136 University Of Miami Crohn'S And Colitis CenterMiami, Florida, United States, 33136 University Of Miami Hospital And ClinicsMiami, Florida, United States, 33136 University Of Miami HospitalMiami, Florida, United States, 33136 Millenia Surgery CenterOrlando, Florida, United States, 32811 Hmd Research LlcOrlando, Florida, United States, 32819|Boise, Idaho, United States, 83706 Idaho Gastroenterology Associates (Endoscopy Center)Meridian, Idaho, United States, 83642|Shawnee Mission, Kansas, United States, 66217|Houma, Louisiana, United States, 70360 Gulf Coast Surgical CenterHouma, Louisiana, United States, 70360 The Hearing Center (Audiology)Houma, Louisiana, United States, 70360|Chevy Chase, Maryland, United States, 20815 Mgg Group Co., Inc., Chevy Chase Clinical ResearchChevy Chase, Maryland, United States, 20815 Capitol ResearchRockville, Maryland, United States, 20850|Boston, Massachusetts, United States, 02115 Mass Eye And Ear, LongwoodBoston, Massachusetts, United States, 02115 Brigham And Women'S HospitalBoston, Massachusetts, United States, 02215 Brigham And Women'S HospitalChestnut Hill, Massachusetts, United States, 02467 Umass Memorial Medical CenterWorcester, Massachusetts, United States, 01655 University Of Massachusetts Medical SchoolWorcester, Massachusetts, United States, 01655|Caro, Michigan, United States, 48723 Clinical Research Institute Of Michigan, LlcChesterfield, Michigan, United States, 48047 Eastside Endoscopy CenterMacomb, Michigan, United States, 48044 Eastside Endoscopy CenterSaint Clair Shores, Michigan, United States, 48081|Ocean Springs, Mississippi, United States, 39564|New York, New York, United States, 10021 New York Presbyterian Hospital - Weill Cornell Medical College (Colonoscopy)New York, New York, United States, 10065 New York Presbyterian Hospital - Weill Cornell Medical College Investigational PharmacyNew York, New York, United States, 10065 Weill Cornell Medical College - New York Presbyterian Hospital (Endoscopy Suite)New York, New York, United States, 10065 Weill Cornell Medical College - New York Presbyterian HospitalNew York, New York, United States, 10065 Digiovanna Institute For Medical Education And ResearchNorth Massapequa, New York, United States, 11758-1853|Chapel Hill, North Carolina, United States, 27514 Unc Hospitals Endoscopy Center At MeadowmontChapel Hill, North Carolina, United States, 27517 University Of North Carolina At Chapel HillChapel Hill, North Carolina, United States, 27599 Gastroenterology Associates Of The Piedmont, PaWinston-Salem, North Carolina, United States, 27103 Pmg Research Of Winston-Salem, LlcWinston-Salem, North Carolina, United States, 27103|Oklahoma City, Oklahoma, United States, 73112|Kingsport, Tennessee, United States, 37660 Holston Valley Surgery CenterKingsport, Tennessee, United States, 37660 Vanderbilt University Medical CenterNashville, Tennessee, United States, 37212-1375 Vanderbilt University Medical CenterNashville, Tennessee, United States, 37212-1610 Vanderbilt University Medical Center - Gi Endoscopy LabNashville, Tennessee, United States, 37232-5543 Vanderbilt University Medical CenterNashville, Tennessee, United States, 37232-7610 Vanderbilt University Medical Center - Gi Research RegulatoryNashville, Tennessee, United States, 37232|Arlington, Texas, United States, 76012 Envision Imaging (Cxr)Arlington, Texas, United States, 76012 Texas Clinical Research Institiute, LlcArlington, Texas, United States, 76012 First Street HospitalBellaire, Texas, United States, 77401 Hrmd ResearchDallas, Texas, United States, 75240 Pearland Surgery CenterHouston, Texas, United States, 77047 Gulf Coast Research Group, LlcHouston, Texas, United States, 77098 Lonestar Endoscopy, LlpSouthlake, Texas, United States, 76092 Texas Digestive Disease ConsultantsSouthlake, Texas, United States, 76092|Fairfax, Virginia, United States, 22031","Alabama|California|Colorado|Florida|Idaho|Kansas|Louisiana|Maryland|Massachusetts|Michigan|Mississippi|New York|North Carolina|Oklahoma|Tennessee|Texas|Virginia","Australia|Austria|Belgium|Bosnia And Herzegovina|Canada|Croatia|Czechia|France|Georgia|Germany|Hungary|Italy|Kuwait|Lebanon|Poland|Saudi Arabia|Serbia|Slovakia|South Africa|Spain|Switzerland|Tunisia|Turkey|Ukraine|United Arab Emirates|United States","New South Wales Concord Repatriation General Hospital|Queensland Mater Misericordiae Ltd|Saint John Of God Health Care Inc.|Victoria Ballarat Base Hospital|Akh Wien Universitaetsklinik Fuer Innere Medizin Iii|University Hospital Brussels|Javna Zdravstvena Ustanova Univerzitetski Klinicki Centar Republike Srpske,|Manitoba Winnipeg Regional Health Authority - Health Sciences Centre, Winnipeg|Ontario HÃ´pital Montfort|Quebec Ciusss De L'Est-De-L'Ile-De-Montreal Installation Hopital Maisonneuve-Rosemont|Hrvatska Klinicki Bolnicki Centar Sestre Milosrdnice|Klinicki Bolnicki Centar Rijeka, Odjel Za Gastroenterologiju|Lekarna Altea|Hospital|The First University Clinic Of Tsmu|Paian Med Research Gmbh|Bekes Megyei Kozponti Korhaz, Rethy Pal Tagkorhaz|A.O.U. Policlinico G. Martino|Bari Irccs Saverio De Bellis|Bs A.O.Spedali Civili|Cz Univ. \"Magna Graecia\" Di Catanzaro|Mb Asst Monza|Milan Istituto Clinico Humanitas Irccs - Ibd Center|Milano Asst Rhodense - Ospedale Di Circolo Di Rho|Hospital - Dubai|Saint George Hospital University Medical Center|Niepubliczny Zaklad Opieki Zdrowotnej All-Medicus|Silesia H-T. Centrum Medyczne-Endoterapia|King Abdulaziz Medical City|Beograd Klinicko Bolnicki Centar \"Bezanijska Kosa\"|Klinicko Bolnicki Centar Zvezdara, Klinika Za Interne Bolesti,|Srbija Klinicki Centar Srbije, Klinika Za Gastroenterohepatologiju|Fakultna Nemocnica S Poliklinikou F.D. Roosevelta Banska Bystrica|, Gauteng Lenasia Clinical Trial Centre|, Western Cape Dr Wright Private Practice|Cantabria Hospital Universitario Marques De Valdecilla|Hospital Universitario Ramon Y Cajal|Verein Ibd Study Group|La Rabta Hospital|Ankara Universitesi Tip Fakultesi, Ibn-I Sina Hastanesi, Ic Hastaliklari Anabilim Dali,|Regional Municipal Institution \"Chernivtsi Regional Clinical Hospital\", Gastroenterology Department,|Cleveland Clinica Abu Dhabi, Department Of Gastroenterology And Hepatology|Dothan Surgery Center|Brighton Surgical Center|Front Range Endoscopy Center|Gastro Florida|Treasure Valley Medical Research|Westglen Gastrointestinal Consultants, P.A.|Cronola, Llc|Chevy Chase Endoscopy Center|Brigham And Women's Hospital|Caro Health Plaza|Digestive Health Center|Weill Cornell Medical College (Clinical Site)|Unc Hospitals|Digestive Disease Specialists, Inc.|Holston Medical Group|Cross Timbers Surgery Center L.P. (Colonoscopy)|Verity Research, Inc.",{"$nulls":3},"Pfizer CT.gov Call Center","2020-02-04","2020-05-25T16:36:06.166","2020-05-26T17:10:42.972","NCT03395184"]
["5ecbf3f511702c1b1b916a1e","NCT03395184","2020-03-10","Pfizer","PFE","Recruiting","Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PFâ€‘06700841 In Subjects With Moderate To Severe Crohn's Disease","Brepocitinib|Pf-06651600","JAK1 Inhibitor|TYK2 Inhibitor|JAK1 Inhibitor|JAK3 Inhibitor","Yes","['Brepocitinib', 'Pf-06651600']","Yes","['TYK2 Inhibitor', 'JAK3 Inhibitor']","Phase 2",2,250,"Anticipated","2018-02-02","2022-11-30","DAS","Disease Activity Score",{"$nulls":3},"The objectives of this study are to evaluate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-06651600 (200 mg for 8 weeks followed by 50 mg for 4 weeks) dosed once daily and PF-06700841 (60 mg for 12 weeks) dosed once daily during an induction period of 12 weeks, followed by an open label extension period at doses of 50 mg and 30 mg of PF 06651600 and PF 06700841, respectively, for 52 weeks.",null,"A PHASE 2A, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ORAL PF-06651600 AND PF-06700841 AS INDUCTION AND OPEN LABEL EXTENSION TREATMENT IN SUBJECTS WITH MODERATE TO SEVERE CROHN'S DISEASE","B7981007","Crohn's Disease","Crohn Disease","Gastrointestinal Diseases","Gastrointestinal","Experimental","PF-06700841 or placebo|PF-06651600 or placebo",null,"Drug","Placebo PF-06700841|PF-06700841|Placebo PF-06651600|PF-06651600","12 weeks, followed by PF-06700841, 30 mg QD for 52 weeks.|60 mg QD for 12 weeks followed by 30 mg QD for up to 52 weeks|12 weeks, followed by PF-06651600, 50 mg QD for 52 weeks|200 mg QD for 8 weeks, followed by 50 mg QD up to 56 weeks",null,"PF-06700841 or placebo|PF-06651600 or placebo","\n\n 1. Male and/or female subjects 18 years to 75 years of age\n 2. Documented diagnosis of ileal, ileocolonic, or colonic CD with a minimum disease duration of 3 months, as determined by endoscopic and histopathology assessment.\n 3. Endoscopic confirmation of active disease with total SES CD total score of at least 7. For isolated ileal disease, SES CD total score should be at least 4.\n 4. An average daily liquid/soft stool frequency (SF) greater than or equal to 2.5 or daily abdominal pain (AP) greater than or equal to 2.0.\n 5. Must have inadequate response to, loss of response to, or intolerance to at least one conventional therapy for CD:â€¢Steroids; Immunosuppressants (azathioprine [AZA], 6 MP, or methotrexate [MTX]); Anti TNF inhibitors (infliximab, adalimumab,certolizumab); Anti integrin inhibitors (eg, vedolizumab); Anti IL 12/23 inhibitor (ustekinumab).\n    \n    \n 6. Subjects currently receiving the following treatment for CD are eligible providing they have been on stable doses as described below: * Oral corticosteroids (prednisone or equivalent up to 25 mg/day; budesonide up to 9 mg/day). Stable dose for at least 2 weeks prior to baseline. If oral corticosteroids have been recently discontinued, they must have been stopped at least 2 weeks prior to baseline. Decreases in steroid use due to AEs are allowed.\n     * Oral 5 ASA or sulfasalazine are allowed providing that the dose is stable for at least 4 weeks prior to baseline.\n     * Crohn's disease related antibiotics are allowed providing that the dose is stable for at least 4 weeks prior to baseline. If antibiotics are stopped prior to baseline, they must be discontinued at least 4 days prior to baseline.\n    \n    \n\n","\n\n 1.  Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, diverticular disease, ulcerative colitis (UC), or clinical findings suggestive of UC.\n 2.  Presence of active (draining) fistulae or intra abdominal or perineal abscesses.\n 3.  Strictures with obstructive symptoms.\n 4.  Short bowel syndrome.\n 5.  History of bowel perforation requiring surgical intervention within the past 12 months.\n 6.  Previous bowel surgery resulting in an existing stoma. Subjects who have a j pouch are excluded, as a j pouch can result in a stoma.\n 7.  History of bowel surgery within 6 months prior to baseline.\n 8.  Subjects displaying clinical signs of fulminant colitis or toxic megacolon.\n 9.  Subjects with primary sclerosing cholangitis.\n 10. Subjects with evidence of colonic adenomas, dysplasia or neoplasia.\n 11. Abnormal findings on the chest x ray film such as presence of tuberculosis (TB), general infections, heart failure, or malignancy.\n 12. Any history of either untreated or inadequately treated latent or active TB infection, current treatment for active or latent TB infection or evidence of currently active TB by chest x ray, residing with or frequent close contact with individual(s) with active TB.\n 13. Subjects receiving the following therapies within the time period described below or expected to receive any of these therapies during the study period: 1.  >9 mg/day of oral budesonide or >25 mg/day of prednisone or equivalent oral systemic corticosteroid dose within 2 weeks prior to baseline.\n      2.  IV, IM (parenteral), or topical (rectal) treatment of 5 ASA or corticosteroid enemas/suppositories within 2 weeks prior to baseline.\n      3.  Azathioprine, 6 mercaptopurine, or methotrexate within 2 weeks prior to baseline.\n      4.  Anti TNF inhibitors (or biosimilars thereof) as described below: * Infliximab within 8 weeks prior to baseline;\n           * Adalimumab within 8 weeks prior to baseline;\n           * Certolizumab within 8 weeks prior to baseline;\n          \n          \n      5.  Anti integrin inhibitors (eg, vedolizumab) within 8 weeks prior to baseline.\n      6.  Ustekinumab within 8 weeks prior to baseline.\n      7.  Interferon therapy within 8 weeks prior to baseline.\n      8.  Subjects with prior treatment with lymphocyte depleting agents/therapies within 1 year prior to baseline (eg, CamPath[alemtuzumab], alkylating agents [eg, cyclophosphamide or chlorambucil], total lymphoid irradiation, etc).\n      9.  Subjects who have received rituximab or other selective B lymphocyte depleting agents within 1 year prior to baseline.\n      10. Subjects previously receiving leukocyte apheresis, including selective lymphocyte, monocyte, or granulocyte apheresis, or plasma exchange within 6 months prior to baseline.\n      11. Other marketed immunosuppressants or biologics with immunomodulatory properties within 3 months prior to baseline.\n      12. Subjects who have received other JAK inhibitors within 3 months prior to baseline.\n      13. Subjects who have not responded to or have been intolerant of other JAK inhibitors.\n      14. Other investigational procedures(s) or product(s), such as immunosuppressants used in transplantation (eg, mycophenolate mofetil, cyclosporine, rapamycin, or tacrolimus) or live (attenuated) vaccine within 30 days prior to baseline.","TNF","tumor necrosis factor","Protein","Lung, Breast, Ovary","Actual","2018-01-10","Actual","Anticipated","2022-11-30","Anticipated","2020-03-01","2017-12-05","2018-01-03","2020-03-09","Yes",null,"Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years","75 Years","All",null,"No","Yes\nPfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",null,"URL: https://pmiform.com/clinical-trial-info-request?StudyID=B7981007 [https://pmiform.com/clinical-trial-info-request?StudyID=B7981007] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To obtain contact information for a study center near you, click here.",null,"Yes","No",{"$nulls":17},"2017-003359-43|PIZZICATO","EudraCT Number|Alias Study Number","Proportion of subjects achieving clinically meaningful endoscopic improvement (reduction of more than or equal to 3 points from baseline in Simplified Endoscopic Activity Score for Crohn's Disease (SES-CD) at Week 12|Number of subjects with adverse events|Number of subjects with serious adverse events|Number of subjects with electrocardiogram findings of potential clinical importance|Number of subjects with laboratory tests findings of potential clinical importance|Number of subjects withdrawal due to adverse events|Number of subjects with vital signs findings of potential clinical importance","12 weeks|Baseline of extension period (Week 12) to week 68",null,"Number of participants with potentially clinically important serious infections findings|Mean change from baseline in SES-CD score at Week 12.|Proportion of subjects achieving SES-CD 25 and SES-CD 50 at Week 12.|Proportion of subjects achieving endoscopic remission (SES-CD less than or equal to 2) at Week 12.|Proportion of subjects achieving mucosal healing at Week 12.|Number of subjects with adverse events|Number of subjects with serious adverse events|Number of subjects with electrocardiogram findings of potential clinical importance.|Number of subjects withdrawal due to adverse events|Number of subjects with vital signs findings of potential clinical importance.|Number of subjects with laboratory tests findings of potential clinical importance.|Proportion of subjects achieving SES CD 25 and SES CD 50 at Week 64 among subjects who achieved SES CD 25 and SES CD 50 at week 12 respectively.|Proportion of subjects achieving clinically meaningful endoscopic improvement (CMEI response) at week 64 among subjects who achieved CMEI response at Week 12.","64 weeks|Baseline, week 12|Number of subjects achieving SES-CD 25 and SES-CD 50 at Week 12.|Number of subjects achieving endoscopic remission (SES-CD less than or equal to 2) at Week 12.|Number of subjects achieving mucosal healing at Week 12.|Number of participants with reported adverse events|Number of participants with reported serious adverse events|Number of participants with potentially clinically important electrocardiogram findings.|Number of subjects withdrawal due to adverse events.|Number of participants with potentially clinically important vital signs findings.|Number of participants with potentially clinically important laboratory findings.|Number of subjects achieving SES-CD 25 and SES-CD 50 at Week 64 among subjects who achieved SES CD 25 and SES CD 50 at week 12|Number of subject achieving clinically meaningful endoscopic improvement (CMEI response) at week 64 among subjects who achieved CMEI response at week 12.","Baseline, week 12|Week 12|Baseline of induction period to week 12|week 64","ClinicalTrials.gov_Inquiries@pfizer.com","Pfizer CT.gov Call Center","1-800-718-1021","Concord, New South Wales, Australia, 2139|South Brisbane, Queensland, Australia, 4101|Subiaco, Western|Ballarat, Victoria, Australia, 3350|Wien, Austria, 1090|Jette, Belgium, 1090 University Hospitals LeuvenLeuven, Belgium, 3000 Chc - Saint-JosephLiÃ¨ge, Belgium, 4000|Banja Luka, Bosnia And Herzegovina, 78000 Sveucilisna Klinicka Bolnica Mostar,Mostar, Bosnia And Herzegovina, 88000|Winnipeg, Manitoba, Canada, R3A 1R9|Ottawa, Ontario, Canada, K1K 0T2|Mont-Royal, Quebec, Canada, H3P 2V9 Cmiim (Le Centre Des Maladies Inflammatoires Et Intestinales De Montreal)Mont-Royal, Quebec, Canada, H3P 3E5 Ciusss De L'Est-De-L'Ile-De-Montreal Installation Hopital Maisonneuve-RosemontMontreal, Quebec, Canada, H1T 2M4|Zagreb, Hrvatska, Croatia, 10000|Rijeka, Croatia, 51000 Klinicki Bolnicki Centar Split, Zavod Za GastroenterologijuSplit, Croatia, 21000 Opca Bolnica Zadar, Odjel Za GastroenterologijuZadar, Croatia, 23000 Klinicka Bolnica Dubrava ZagrebZagreb, Croatia, 10000 Klinicki Bolnicki Centar Zagreb, Zavod Za Gastroenterologiju I HepatologijuZagreb, Croatia, 10000|Bilina, Czechia, 41801 Nemocnice Horovice, A.S.Horovice, Czechia, 268 31 Hepato-Gastroenterologie Hk S.R.O.Hradec Kralove, Czechia, 500 12 Medialpharma S.R.O.Hradec Kralove, Czechia, 500 12 Gastroenterologicka Ambulance A EndoskopieMost, Czechia, 43401 Vseobecna Fakultni NemocnicePraha 2, Czechia, 128 08 VÅ¡eobecnÃ¡ FakultnÃ­ Nemocnice V PrazePraha 2, Czechia, 128 08 Lekarna Sv. AnnaPraha 3, Czechia, 130 00 Egk S.R.O. - Sanatorium Sv. AnnyPraha 3, Czechia, 13000 Fakultni Nemocnice V MotolePraha 5, Czechia, 150 06 FakultnÃ­ Nemocnice V MotolePraha 5, Czechia, 150 06 Nemocnice Strakonice, A.S., Interni OddeleniStrakonice, Czechia, 386 01 Nemocnice Strakonice, A.S.Strakonice, Czechia, 386 29|Achrafieh, Beirut, Lebanon|Tbilisi, Georgia, 0141 Institute Of Clinical Cardiology, Ltd.Tbilisi, Georgia, 0159 David Tatishvili Medical CenterTbilisi, Georgia, 0186|Berlin, Germany, 10318 Krankenhaus Waldfriede E.V.,Berlin, Germany, 14163 Universitaetsklinikum BonnBonn, Germany, 53127 Universitaetsklinikum Schleswig-HolsteinKiel, Germany, 24105 UniversitÃ¤tsklinikum Giessen Und Marburg GmbhMarburg, Germany, 35043|Bekescsaba, Hungary, 5600 Semmelweis Egyetem, Ii. Belgyogyaszati KlinikaBudapest, Hungary, 1088 Szent Janos Korhaz Es Eszak-Budai Egyesitett Korhazak[Active, Not Recruiting]Budapest, Hungary, 1125 Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz, Endoszkopos LaboratoriumGyula, Hungary, 5700 Clinfan Szolgaltato Kft.Szekszard, Hungary, 7100 Csolnoky Ferenc Korhaz Belgyogyaszati Centrum I. Belgyogyaszati OsztalyVeszprem, Hungary, 8200|Messina, Italy, 98125 Aou Policlinico Di ModenaModena, Italy, 41124 Azienda Ospedaliera Di PadovaPadova, Italy, 35128 Policlinico Universitario Campus Bio-MedicoRoma, Italy, 00128 Policlinico Gemelli/Complesso Integrato ColumbusRome, Italy, 00168 Korea, Republic Of, Korea Kyungpook National University HospitalDaegu, Korea, Korea, Republic Of, 41944 Korea, Republic Of Kyung Hee University HospitalSeoul, Korea, Republic Of, 02447 Kangbuk Samsung HospitalSeoul, Korea, Republic Of, 03181 Severance Hospital, Yonsei University Health SystemSeoul, Korea, Republic Of, 03722 The Catholic University Of Korea, Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591|Castellana Grotte, Bari, Italy, 70013|Brescia, Bs, Italy, 25123|Catanzaro, Cz, Italy, 88100|Monza, Mb, Italy, 20090|Rozzano, Milan, Italy, 20089|Rho, Milano, Italy, 20017|Dubai, United Arab Emirates, 22241 Emirates Specialty HospitalDubai, United Arab Emirates, Po Box 505240|Achrafieh, Lebanon American University Of Beirut Medical CenterBeirut, Lebanon Ain Wazein Medical VillageEl Chouf, Lebanon Centre Hospitalier Universitaire Notre Dame De SecoursJbeil, Lebanon Hammoud Hospital University Medical CenterSaida, Lebanon|Katowice, Poland, 40-659 Etg KielceKielce, Poland, 25-355 Indywidualna Specjalistyczna Praktyka Lekarska Maciej ZymlaKnurow, Poland, 44-190 Szpital W Knurowie Sp. Z O.O.Knurow, Poland, 44-190 Centrum Badan Klinicznych JciKrakow, Poland, 30-348 Marta Dagmara Banach Marta Banach Specjalistyczny Gabinet NeurologicznyKrakow, Poland, 30-539 Centrum Medyczne EvitaKrakow, Poland, 31-153 Szpital Specjalistyczny Im. Ludwika Rydygiera W Krakowie Sp. Z O.O.Krakow, Poland, 31-826 Centrum Medyczne Szpital Swietej Rodziny Sp Z O.O.Lodz, Poland, 90-302 Pracownia Endoskopii Centrum Medyczne Szpital Swietej Rodziny Sp Z O.O.Lodz, Poland, 90-302 Medical Magnus ClinicLodz, Poland, 90-552 Wojewodzki Szpital Specjalistyczny Im. Bieganskiego W LodziLodz, Poland, 91-347 Gastromed Sp. Z O.O.Lublin, Poland, 20-582 Ai Centrum Medyczne Sp. Z O.O. Sp.K.Poznan, Poland, 61-113 Korczowski Bartosz Gabinet LekarskiRzeszow, Poland, 35-302 Endoskopia Sp. Z O. O.Sopot, Poland, 81-756 Szpital Sredzki Serca Jezusowego Sp. Z O.O.Sroda Wielkopolska, Poland, 63-000 Ez-Med Sp. Z O.O. Sp.K.Swidnica, Poland, 58-100 Pracownia Endoskopii Szpital MswSzczecin, Poland, 70-001 Twoja Przychodnia Szczecinskie Centrum MedyczneSzczecin, Poland, 71-434 Gastromed Kopon, Zmudzinski I Wspolnicy Sp.J.Torun, Poland, 87-100 Centrum Zdrowia MdmWarszawa, Poland, 00-635 Wip Warsaw Ibd Point Profesor KierkusWarszawa, Poland, 00-728 Endoterapia Pfg Sp. Z O.O.Warszawa, Poland, 02-653 Centrum Diagnostyczno-Lecznicze Barska Sp. Z O. O.Wloclawek, Poland, 87-800 Melita Medical Sp. Z O.O.Wroclaw, Poland, 50-449 Centrum Gastrologiczno HepatologiczneWroclaw, Poland, 50-555 Planetmed Sp. Z.O.O.Wroclaw, Poland, 52-210 LexmedicaWroclaw, Poland, 53-114 Russian Federation, Sestroretsk Spb Sbih \"City Hospital #40 Of The Kurortnyi Region\"Saint-Petersburg, Sestroretsk, Russian Federation, 197706 Russian Federation Llc \"Alliance Biomedical-Ural Group\"Izhevsk, Russian Federation, 426061 Clinic Of Fsbei He Ksmu Moh RfKrasnodar, Russian Federation, 350072 Llc \"Olla-Med\"Moscow, Russian Federation, 105554 Sechenov University On The Base Of Institute Of Translational Medicine And BiotechnologyMoscow, Russian Federation, 119435 Limited Liability Company \"Medical Center Sibnovomed\"Novosibirsk, Russian Federation, 630005 Federal State Budgetary Scientific Institution \"Scientific Research Institute Of Physiology AndNovosibirsk, Russian Federation, 630117 Clinic At Fsbei He \"Omsk State Medical University\" Moh RfOmsk, Russian Federation, 644050 Llc \"New Clinic\"Pyatigorsk, Russian Federation, 357500 Limited Liability Company \"Riat\"Saint-Petersburg, Russian Federation, 195220 Saint-Petersburg State Budgetary Healthcare Institution \"City Hospital #26\"Saint-Petersburg, Russian Federation, 196247 Private Institution Educational Organization Of Higher EducationSamara, Russian Federation, 443011 Non-State Healthcare Institution 'Railway Clinical Hospital At Samara Station Of Open Joint StockSamara, Russian Federation, 443029 Limited Liability Company Medical Company \"Hepatolog\"Samara, Russian Federation, 443093 Saint-Petersburg State Budgetary Healthcare Institution \"City Clinical Hospital Of The RighteousSt. Petersburg, Russian Federation, 197706|Tychy, Silesia, Poland, 43-100|Riyadh, Saudi Arabia, 11426 King Khalid University HospitalRiyadh, Saudi Arabia, 11472|Zemun, Beograd, Serbia, 11080|Beograd, Serbia, 11000 Vojnomedicinska Akademija, Klinika Za Gastroenterologiju I HepatologijuBeograd, Serbia, 11000 Kbc \"Dr Dragisa Misovic-Dedinje\"Beograd, Serbia, 11040 Klinicko Bolnicki Centar Zemun, Klinika Za Internu Medicinu,Zemun, Beograd, Serbia, 11080|Beograd, Srbija, Serbia, 11000 Klinicki Centar KragujevacKragujevac, Srbija, Serbia, 34000 Klinicki Centar NisNis, Srbija, Serbia, 18000 Opsta Bolnica SuboticaSubotica, Srbija, Serbia, 24000 Opsta Bolnica \"Djordje Joanovic\", Odeljenje Interno, Odsek GastroenterologijaZrenjanin, Srbija, Serbia, 23000|Banska Bystrica, Slovakia, 975 17 Breznianske Centrum Gastroenterologie S.R.O.Brezno, Slovakia, 97701 Km Management Spol. S.R.O.Nitra, Slovakia, 949 01 Accout Center S.R.O. Gastroenterologicka AmbulanciaSahy, Slovakia, 936 01 Endomed, S.R.O.Vranov Nad Toplou, Slovakia, 093 01|Lenasia, Gauteng, South Africa, 1827 Wits Clinical Research Trial SiteParktown, Gauteng, South Africa, 2193 Wits Clinical Reasearch - Wits Bara Clinical Trial SiteSoweto, Gauteng, South Africa, 2013|Claremont, Western Cape, South Africa, 7708|Santander, Cantabria, Spain, 39008|Madrid, Spain, 28034 Hospital Universitario Virgen Del RocioSevilla, Spain, 41013 Hospital Universitari I Politecnic La FeValencia, Spain, 46026|Bern, Switzerland, Ch - 3012 UniversitÃ¤tsspital ZÃ¼richZÃ¼rich, Switzerland, Ch-8091|Tunis, Tunisia, 1007 Habib Thameur HospitalTunis, Tunisia, 1008|Ankara, Turkey, 06100 Ankara Universitesi Tip Fakultesi, Ibn-I Sina HastanesiAnkara, Turkey, 06100 Hacettepe Universitesi Tip FakultesiAnkara, Turkey, 06230 Bezmialem Vakif Universitesi Tip Fakultesi HastanesiIstanbul, Turkey, 34093 Istanbul Universitesi Cerrahpasa Tip FacultesiIstanbul, Turkey, 34098 Istanbul Universitesi Cerrahpasa Tip FakultesiIstanbul, Turkey, 34098 Erciyes Universitesi Tip FakultesiKayseri, Turkey, 38039 Kocaeli Universitesi Tip FakultesiKocaeli, Turkey, 41380 Mersin Universitesi Tip Fakultesi Hastanesi, Ic HastaliklariMersin, Turkey, 33110 Mersin Universitesi Tip Fakultesi HastanesiMersin, Turkey, 33110 Karadeniz Teknik Universitesi Tip Fakultesi, Ic HastaliklariTrabzon, Turkey, 61080 Karadeniz Teknik Universitesi Tip FakultesiTrabzon, Turkey, 61080 Bulent Ecevit Universitesi Tip FakultesiZonguldak, Turkey, 67600|Chernivtsi, Ukraine, 58001 Regional Municipal Institution \"Chernivtsi Regional Clinical Hospital\", Surgery DepartmentChernivtsi, Ukraine, 58001 Municipal Healthcare Institution Kharkiv City Clinical Hospital #2 N.A. Prof. O.O. ShalimovKharkiv, Ukraine, 61037 Private Enterprise Of Private Manufacturing Company \"Acinus\", Medical And Diagnostic CenterKropyvnytskyi, Ukraine, 25006 Kyiv Municipal Clinical Hospital #18, Proctology DepartmentKyiv, Ukraine, 01030 Med Centre 'Ok!Clinic+'Kyiv, Ukraine, 02091 Medical Center \"Ok Clinic+\" Of International Institute Of Clinical TrialsKyiv, Ukraine, 02091 Medical Center \"Universal Clinic Oberig\" Of \"Kapital\" Llc, Gastro CenterKyiv, Ukraine, 03680 Lviv Clinical Hospital On Railway Transport Of Health Care Center Branch Of Pjsc Ukrainian RailwayLviv, Ukraine, 79007 Vinnytsia City Clinical Hospital No.1Vinnytsia, Ukraine, 21000 Private Small-Scale Enterprise Medical Center \"Pulse\"Vinnytsia, Ukraine, 21001 Vinnytsia Regional Clinical Hospital For War VeteransVinnytsia, Ukraine, 21005 Vinnytsia Regional Clinical Hospital N.A. M.I.PyrohovVinnytsia, Ukraine, 21018|Abu Dhabi, United Arab Emirates, 112412 Al|Dothan, Alabama, United States, 36301 Gut P.C., Dba Digestive Health Specialists Of The SoutheastDothan, Alabama, United States, 36305|Beverly Hills, California, United States, 90210 Long Beach Clinical Trial Services, Inc.Long Beach, California, United States, 90806 Entertainment Medical GroupLos Angeles, California, United States, 90036 Gastrointestinal Biosciences Clinical Trials, LlcLos Angeles, California, United States, 90067 Alliance Clinical Research, LlcPoway, California, United States, 92064|Colorado Springs, Colorado, United States, 80903 Peak Gastroenterology AssociatesColorado Springs, Colorado, United States, 80907|Clearwater, Florida, United States, 33756-3839 West Coast Endoscopy CenterClearwater, Florida, United States, 33756 Gastro FloridaClearwater, Florida, United States, 33762 Uf Health Jacksonville - Gastroenterology EmersonJacksonville, Florida, United States, 32207 Uf Health Jacksonville - Faculty ClinicJacksonville, Florida, United States, 32209 University Of Miami Clinical Research BuildingMiami, Florida, United States, 33136 University Of Miami Crohn'S And Colitis CenterMiami, Florida, United States, 33136 University Of Miami Hospital And ClinicsMiami, Florida, United States, 33136 University Of Miami HospitalMiami, Florida, United States, 33136 Millenia Surgery CenterOrlando, Florida, United States, 32811 Hmd Research LlcOrlando, Florida, United States, 32819|Boise, Idaho, United States, 83706 Idaho Gastroenterology Associates (Endoscopy Center)Meridian, Idaho, United States, 83642|Shawnee Mission, Kansas, United States, 66217|Houma, Louisiana, United States, 70360 Gulf Coast Surgical CenterHouma, Louisiana, United States, 70360 The Hearing Center (Audiology)Houma, Louisiana, United States, 70360|Chevy Chase, Maryland, United States, 20815 Mgg Group Co., Inc., Chevy Chase Clinical ResearchChevy Chase, Maryland, United States, 20815 Capitol ResearchRockville, Maryland, United States, 20850|Boston, Massachusetts, United States, 02115 Mass Eye And Ear, LongwoodBoston, Massachusetts, United States, 02115 Brigham And Women'S HospitalBoston, Massachusetts, United States, 02215 Brigham And Women'S HospitalChestnut Hill, Massachusetts, United States, 02467 Umass Memorial Medical CenterWorcester, Massachusetts, United States, 01655 University Of Massachusetts Medical SchoolWorcester, Massachusetts, United States, 01655|Caro, Michigan, United States, 48723 Clinical Research Institute Of Michigan, LlcChesterfield, Michigan, United States, 48047 Eastside Endoscopy CenterMacomb, Michigan, United States, 48044 Eastside Endoscopy CenterSaint Clair Shores, Michigan, United States, 48081|Ocean Springs, Mississippi, United States, 39564|New York, New York, United States, 10021 New York Presbyterian Hospital - Weill Cornell Medical College (Colonoscopy)New York, New York, United States, 10065 New York Presbyterian Hospital - Weill Cornell Medical College Investigational PharmacyNew York, New York, United States, 10065 Weill Cornell Medical College - New York Presbyterian Hospital (Endoscopy Suite)New York, New York, United States, 10065 Weill Cornell Medical College - New York Presbyterian HospitalNew York, New York, United States, 10065 Digiovanna Institute For Medical Education And ResearchNorth Massapequa, New York, United States, 11758-1853|Chapel Hill, North Carolina, United States, 27514 Unc Hospitals Endoscopy Center At MeadowmontChapel Hill, North Carolina, United States, 27517 University Of North Carolina At Chapel HillChapel Hill, North Carolina, United States, 27599 Gastroenterology Associates Of The Piedmont, PaWinston-Salem, North Carolina, United States, 27103 Pmg Research Of Winston-Salem, LlcWinston-Salem, North Carolina, United States, 27103|Oklahoma City, Oklahoma, United States, 73112|Kingsport, Tennessee, United States, 37660 Holston Valley Surgery CenterKingsport, Tennessee, United States, 37660 Vanderbilt University Medical CenterNashville, Tennessee, United States, 37212-1375 Vanderbilt University Medical CenterNashville, Tennessee, United States, 37212-1610 Vanderbilt University Medical Center - Gi Endoscopy LabNashville, Tennessee, United States, 37232-5543 Vanderbilt University Medical CenterNashville, Tennessee, United States, 37232-7610 Vanderbilt University Medical Center - Gi Research RegulatoryNashville, Tennessee, United States, 37232|Arlington, Texas, United States, 76012 Envision Imaging (Cxr)Arlington, Texas, United States, 76012 Texas Clinical Research Institiute, LlcArlington, Texas, United States, 76012 First Street HospitalBellaire, Texas, United States, 77401 Pearland Surgery CenterHouston, Texas, United States, 77047 Lonestar Endoscopy, LlpSouthlake, Texas, United States, 76092 Texas Digestive Disease ConsultantsSouthlake, Texas, United States, 76092|Fairfax, Virginia, United States, 22031","Alabama|California|Colorado|Florida|Idaho|Kansas|Louisiana|Maryland|Massachusetts|Michigan|Mississippi|New York|North Carolina|Oklahoma|Tennessee|Texas|Virginia","Australia|Austria|Belgium|Bosnia And Herzegovina|Canada|Croatia|Czechia|France|Georgia|Germany|Hungary|Italy|Kuwait|Lebanon|Poland|Saudi Arabia|Serbia|Slovakia|South Africa|Spain|Switzerland|Tunisia|Turkey|Ukraine|United Arab Emirates|United States","New South Wales Concord Repatriation General Hospital|Queensland Mater Misericordiae Ltd|Saint John Of God Health Care Inc.|Victoria Ballarat Base Hospital|Akh Wien Universitaetsklinik Fuer Innere Medizin Iii|University Hospital Brussels|Javna Zdravstvena Ustanova Univerzitetski Klinicki Centar Republike Srpske,|Manitoba Winnipeg Regional Health Authority - Health Sciences Centre, Winnipeg|Ontario HÃ´pital Montfort|Quebec Rocklandmd|Hrvatska Klinicki Bolnicki Centar Sestre Milosrdnice|Klinicki Bolnicki Centar Rijeka, Odjel Za Gastroenterologiju|Lekarna Altea|Hospital|The First University Clinic Of Tsmu|Paian Med Research Gmbh|Bekes Megyei Kozponti Korhaz, Rethy Pal Tagkorhaz|A.O.U. Policlinico G. Martino|Bari Irccs Saverio De Bellis|Bs A.O.Spedali Civili|Cz Univ. \"Magna Graecia\" Di Catanzaro|Mb Asst Monza|Milan Istituto Clinico Humanitas Irccs - Ibd Center|Milano Asst Rhodense - Ospedale Di Circolo Di Rho|Hospital - Dubai|Saint George Hospital University Medical Center|Niepubliczny Zaklad Opieki Zdrowotnej All-Medicus|Silesia H-T. Centrum Medyczne-Endoterapia|King Abdulaziz Medical City|Beograd Klinicko Bolnicki Centar \"Bezanijska Kosa\"|Klinicko Bolnicki Centar Zvezdara, Klinika Za Interne Bolesti,|Srbija Klinicki Centar Srbije, Klinika Za Gastroenterohepatologiju|Fakultna Nemocnica S Poliklinikou F.D. Roosevelta Banska Bystrica|, Gauteng Lenasia Clinical Trial Centre|, Western Cape Dr Wright Private Practice|Cantabria Hospital Universitario Marques De Valdecilla|Hospital Universitario Ramon Y Cajal|Verein Ibd Study Group|La Rabta Hospital|Ankara Universitesi Tip Fakultesi, Ibn-I Sina Hastanesi, Ic Hastaliklari Anabilim Dali,|Regional Municipal Institution \"Chernivtsi Regional Clinical Hospital\", Gastroenterology Department,|Cleveland Clinica Abu Dhabi, Department Of Gastroenterology And Hepatology|Dothan Surgery Center|Brighton Surgical Center|Front Range Endoscopy Center|Gastro Florida|Treasure Valley Medical Research|Westglen Gastrointestinal Consultants, P.A.|Cronola, Llc|Chevy Chase Endoscopy Center|Brigham And Women's Hospital|Caro Health Plaza|Digestive Health Center|Weill Cornell Medical College (Clinical Site)|Unc Hospitals|Digestive Disease Specialists, Inc.|Holston Medical Group|Cross Timbers Surgery Center L.P. (Colonoscopy)|Verity Research, Inc.",{"$nulls":3},"Pfizer CT.gov Call Center","2020-03-09","2020-05-25T16:36:05.724","2020-05-26T17:10:42.972","NCT03395184"]
["5ecbf3f6e2561b1b11905d09","NCT03395184","2020-03-27","Pfizer","PFE","Recruiting","Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PFâ€‘06700841 In Subjects With Moderate To Severe Crohn's Disease","Brepocitinib|Pf-06651600","JAK1 Inhibitor|TYK2 Inhibitor|JAK1 Inhibitor|JAK3 Inhibitor","Yes","['Brepocitinib', 'Pf-06651600']","Yes","['TYK2 Inhibitor', 'JAK3 Inhibitor']","Phase 2",2,250,"Anticipated","2018-02-02","2022-11-30","DAS","Disease Activity Score",{"$nulls":3},"The objectives of this study are to evaluate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-06651600 (200 mg for 8 weeks followed by 50 mg for 4 weeks) dosed once daily and PF-06700841 (60 mg for 12 weeks) dosed once daily during an induction period of 12 weeks, followed by an open label extension period at doses of 50 mg and 30 mg of PF 06651600 and PF 06700841, respectively, for 52 weeks.",null,"A PHASE 2A, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ORAL PF-06651600 AND PF-06700841 AS INDUCTION AND OPEN LABEL EXTENSION TREATMENT IN SUBJECTS WITH MODERATE TO SEVERE CROHN'S DISEASE","B7981007","Crohn's Disease","Crohn Disease","Gastrointestinal Diseases","Gastrointestinal","Experimental","PF-06700841 or placebo|PF-06651600 or placebo",null,"Drug","Placebo PF-06700841|PF-06700841|Placebo PF-06651600|PF-06651600","12 weeks, followed by PF-06700841, 30 mg QD for 52 weeks.|60 mg QD for 12 weeks followed by 30 mg QD for up to 52 weeks|12 weeks, followed by PF-06651600, 50 mg QD for 52 weeks|200 mg QD for 8 weeks, followed by 50 mg QD up to 56 weeks",null,"PF-06700841 or placebo|PF-06651600 or placebo","\n\n 1. Male and/or female subjects 18 years to 75 years of age\n 2. Documented diagnosis of ileal, ileocolonic, or colonic CD with a minimum disease duration of 3 months, as determined by endoscopic and histopathology assessment.\n 3. Endoscopic confirmation of active disease with total SES CD total score of at least 7. For isolated ileal disease, SES CD total score should be at least 4.\n 4. An average daily liquid/soft stool frequency (SF) greater than or equal to 2.5 or daily abdominal pain (AP) greater than or equal to 2.0.\n 5. Must have inadequate response to, loss of response to, or intolerance to at least one conventional therapy for CD:â€¢Steroids; Immunosuppressants (azathioprine [AZA], 6 MP, or methotrexate [MTX]); Anti TNF inhibitors (infliximab, adalimumab,certolizumab); Anti integrin inhibitors (eg, vedolizumab); Anti IL 12/23 inhibitor (ustekinumab).\n    \n    \n 6. Subjects currently receiving the following treatment for CD are eligible providing they have been on stable doses as described below: * Oral corticosteroids (prednisone or equivalent up to 25 mg/day; budesonide up to 9 mg/day). Stable dose for at least 2 weeks prior to baseline. If oral corticosteroids have been recently discontinued, they must have been stopped at least 2 weeks prior to baseline. Decreases in steroid use due to AEs are allowed.\n     * Oral 5 ASA or sulfasalazine are allowed providing that the dose is stable for at least 4 weeks prior to baseline.\n     * Crohn's disease related antibiotics are allowed providing that the dose is stable for at least 4 weeks prior to baseline. If antibiotics are stopped prior to baseline, they must be discontinued at least 4 days prior to baseline.\n    \n    \n\n","\n\n 1.  Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, diverticular disease, ulcerative colitis (UC), or clinical findings suggestive of UC.\n 2.  Presence of active (draining) fistulae or intra abdominal or perineal abscesses.\n 3.  Strictures with obstructive symptoms.\n 4.  Short bowel syndrome.\n 5.  History of bowel perforation requiring surgical intervention within the past 12 months.\n 6.  Previous bowel surgery resulting in an existing stoma. Subjects who have a j pouch are excluded, as a j pouch can result in a stoma.\n 7.  History of bowel surgery within 6 months prior to baseline.\n 8.  Subjects displaying clinical signs of fulminant colitis or toxic megacolon.\n 9.  Subjects with primary sclerosing cholangitis.\n 10. Subjects with evidence of colonic adenomas, dysplasia or neoplasia.\n 11. Abnormal findings on the chest x ray film such as presence of tuberculosis (TB), general infections, heart failure, or malignancy.\n 12. Any history of either untreated or inadequately treated latent or active TB infection, current treatment for active or latent TB infection or evidence of currently active TB by chest x ray, residing with or frequent close contact with individual(s) with active TB.\n 13. Subjects receiving the following therapies within the time period described below or expected to receive any of these therapies during the study period: 1.  >9 mg/day of oral budesonide or >25 mg/day of prednisone or equivalent oral systemic corticosteroid dose within 2 weeks prior to baseline.\n      2.  IV, IM (parenteral), or topical (rectal) treatment of 5 ASA or corticosteroid enemas/suppositories within 2 weeks prior to baseline.\n      3.  Azathioprine, 6 mercaptopurine, or methotrexate within 2 weeks prior to baseline.\n      4.  Anti TNF inhibitors (or biosimilars thereof) as described below: * Infliximab within 8 weeks prior to baseline;\n           * Adalimumab within 8 weeks prior to baseline;\n           * Certolizumab within 8 weeks prior to baseline;\n          \n          \n      5.  Anti integrin inhibitors (eg, vedolizumab) within 8 weeks prior to baseline.\n      6.  Ustekinumab within 8 weeks prior to baseline.\n      7.  Interferon therapy within 8 weeks prior to baseline.\n      8.  Subjects with prior treatment with lymphocyte depleting agents/therapies within 1 year prior to baseline (eg, CamPath[alemtuzumab], alkylating agents [eg, cyclophosphamide or chlorambucil], total lymphoid irradiation, etc).\n      9.  Subjects who have received rituximab or other selective B lymphocyte depleting agents within 1 year prior to baseline.\n      10. Subjects previously receiving leukocyte apheresis, including selective lymphocyte, monocyte, or granulocyte apheresis, or plasma exchange within 6 months prior to baseline.\n      11. Other marketed immunosuppressants or biologics with immunomodulatory properties within 3 months prior to baseline.\n      12. Subjects who have received other JAK inhibitors within 3 months prior to baseline.\n      13. Subjects who have not responded to or have been intolerant of other JAK inhibitors.\n      14. Other investigational procedures(s) or product(s), such as immunosuppressants used in transplantation (eg, mycophenolate mofetil, cyclosporine, rapamycin, or tacrolimus) or live (attenuated) vaccine within 30 days prior to baseline.","TNF","tumor necrosis factor","Protein","Lung, Breast, Ovary","Actual","2018-01-10","Actual","Anticipated","2022-11-30","Anticipated","2020-03-01","2017-12-05","2018-01-03","2020-03-25","Yes",null,"Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years","75 Years","All",null,"No","Yes\nPfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",null,"URL: https://pmiform.com/clinical-trial-info-request?StudyID=B7981007 [https://pmiform.com/clinical-trial-info-request?StudyID=B7981007] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To obtain contact information for a study center near you, click here.",null,"Yes","No",{"$nulls":17},"2017-003359-43|PIZZICATO","EudraCT Number|Alias Study Number","Proportion of subjects achieving clinically meaningful endoscopic improvement (reduction of more than or equal to 3 points from baseline in Simplified Endoscopic Activity Score for Crohn's Disease (SES-CD) at Week 12|Number of subjects with adverse events|Number of subjects with serious adverse events|Number of subjects with electrocardiogram findings of potential clinical importance|Number of subjects with laboratory tests findings of potential clinical importance|Number of subjects withdrawal due to adverse events|Number of subjects with vital signs findings of potential clinical importance","12 weeks|Baseline of extension period (Week 12) to week 68",null,"Number of participants with potentially clinically important serious infections findings|Mean change from baseline in SES-CD score at Week 12.|Proportion of subjects achieving SES-CD 25 and SES-CD 50 at Week 12.|Proportion of subjects achieving endoscopic remission (SES-CD less than or equal to 2) at Week 12.|Proportion of subjects achieving mucosal healing at Week 12.|Number of subjects with adverse events|Number of subjects with serious adverse events|Number of subjects with electrocardiogram findings of potential clinical importance.|Number of subjects withdrawal due to adverse events|Number of subjects with vital signs findings of potential clinical importance.|Number of subjects with laboratory tests findings of potential clinical importance.|Proportion of subjects achieving SES CD 25 and SES CD 50 at Week 64 among subjects who achieved SES CD 25 and SES CD 50 at week 12 respectively.|Proportion of subjects achieving clinically meaningful endoscopic improvement (CMEI response) at week 64 among subjects who achieved CMEI response at Week 12.","64 weeks|Baseline, week 12|Number of subjects achieving SES-CD 25 and SES-CD 50 at Week 12.|Number of subjects achieving endoscopic remission (SES-CD less than or equal to 2) at Week 12.|Number of subjects achieving mucosal healing at Week 12.|Number of participants with reported adverse events|Number of participants with reported serious adverse events|Number of participants with potentially clinically important electrocardiogram findings.|Number of subjects withdrawal due to adverse events.|Number of participants with potentially clinically important vital signs findings.|Number of participants with potentially clinically important laboratory findings.|Number of subjects achieving SES-CD 25 and SES-CD 50 at Week 64 among subjects who achieved SES CD 25 and SES CD 50 at week 12|Number of subject achieving clinically meaningful endoscopic improvement (CMEI response) at week 64 among subjects who achieved CMEI response at week 12.","Baseline, week 12|Week 12|Baseline of induction period to week 12|week 64","ClinicalTrials.gov_Inquiries@pfizer.com","Pfizer CT.gov Call Center","1-800-718-1021","Concord, New South Wales, Australia, 2139|South Brisbane, Queensland, Australia, 4101|Subiaco, Western|Ballarat, Victoria, Australia, 3350|Wien, Austria, 1090|Jette, Belgium, 1090 University Hospitals LeuvenLeuven, Belgium, 3000 Chc - Saint-JosephLiÃ¨ge, Belgium, 4000|Banja Luka, Bosnia And Herzegovina, 78000 Sveucilisna Klinicka Bolnica Mostar,Mostar, Bosnia And Herzegovina, 88000|Winnipeg, Manitoba, Canada, R3A 1R9|Ottawa, Ontario, Canada, K1K 0T2|Mont-Royal, Quebec, Canada, H3P 2V9 Cmiim (Le Centre Des Maladies Inflammatoires Et Intestinales De Montreal)Mont-Royal, Quebec, Canada, H3P 3E5 Ciusss De L'Est-De-L'Ile-De-Montreal Installation Hopital Maisonneuve-RosemontMontreal, Quebec, Canada, H1T 2M4|Zagreb, Hrvatska, Croatia, 10000|Rijeka, Croatia, 51000 Klinicki Bolnicki Centar Split, Zavod Za GastroenterologijuSplit, Croatia, 21000 Opca Bolnica Zadar, Odjel Za GastroenterologijuZadar, Croatia, 23000 Klinicka Bolnica Dubrava ZagrebZagreb, Croatia, 10000 Klinicki Bolnicki Centar Zagreb, Zavod Za Gastroenterologiju I HepatologijuZagreb, Croatia, 10000|Bilina, Czechia, 41801 Nemocnice Horovice, A.S.Horovice, Czechia, 268 31 Hepato-Gastroenterologie Hk S.R.O.Hradec Kralove, Czechia, 500 12 Medialpharma S.R.O.Hradec Kralove, Czechia, 500 12 Gastroenterologicka Ambulance A EndoskopieMost, Czechia, 43401 Vseobecna Fakultni NemocnicePraha 2, Czechia, 128 08 VÅ¡eobecnÃ¡ FakultnÃ­ Nemocnice V PrazePraha 2, Czechia, 128 08 Lekarna Sv. AnnaPraha 3, Czechia, 130 00 Egk S.R.O. - Sanatorium Sv. AnnyPraha 3, Czechia, 13000 Fakultni Nemocnice V MotolePraha 5, Czechia, 150 06 FakultnÃ­ Nemocnice V MotolePraha 5, Czechia, 150 06 Nemocnice Strakonice, A.S., Interni OddeleniStrakonice, Czechia, 386 01 Nemocnice Strakonice, A.S.Strakonice, Czechia, 386 29|Achrafieh, Beirut, Lebanon|Tbilisi, Georgia, 0141 Institute Of Clinical Cardiology, Ltd.Tbilisi, Georgia, 0159 David Tatishvili Medical CenterTbilisi, Georgia, 0186|Berlin, Germany, 10318 Krankenhaus Waldfriede E.V.,Berlin, Germany, 14163 Universitaetsklinikum BonnBonn, Germany, 53127 Universitaetsklinikum Schleswig-HolsteinKiel, Germany, 24105 UniversitÃ¤tsklinikum Giessen Und Marburg GmbhMarburg, Germany, 35043|Bekescsaba, Hungary, 5600 Semmelweis Egyetem, Ii. Belgyogyaszati KlinikaBudapest, Hungary, 1088 Szent Janos Korhaz Es Eszak-Budai Egyesitett Korhazak[Active, Not Recruiting]Budapest, Hungary, 1125 Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz, Endoszkopos LaboratoriumGyula, Hungary, 5700 Clinfan Szolgaltato Kft.Szekszard, Hungary, 7100 Csolnoky Ferenc Korhaz Belgyogyaszati Centrum I. Belgyogyaszati OsztalyVeszprem, Hungary, 8200|Messina, Italy, 98125 Aou Policlinico Di ModenaModena, Italy, 41124 Azienda Ospedaliera Di PadovaPadova, Italy, 35128 Policlinico Universitario Campus Bio-MedicoRoma, Italy, 00128 Policlinico Gemelli/Complesso Integrato ColumbusRome, Italy, 00168 Korea, Republic Of, Korea Kyungpook National University HospitalDaegu, Korea, Korea, Republic Of, 41944 Korea, Republic Of Kyung Hee University HospitalSeoul, Korea, Republic Of, 02447 Kangbuk Samsung HospitalSeoul, Korea, Republic Of, 03181 Severance Hospital, Yonsei University Health SystemSeoul, Korea, Republic Of, 03722 The Catholic University Of Korea, Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591|Castellana Grotte, Bari, Italy, 70013|Brescia, Bs, Italy, 25123|Catanzaro, Cz, Italy, 88100|Monza, Mb, Italy, 20090|Rozzano, Milan, Italy, 20089|Rho, Milano, Italy, 20017|Dubai, United Arab Emirates, 22241 Emirates Specialty HospitalDubai, United Arab Emirates, Po Box 505240|Achrafieh, Lebanon American University Of Beirut Medical CenterBeirut, Lebanon Ain Wazein Medical VillageEl Chouf, Lebanon Centre Hospitalier Universitaire Notre Dame De SecoursJbeil, Lebanon Hammoud Hospital University Medical CenterSaida, Lebanon|Katowice, Poland, 40-659 Etg KielceKielce, Poland, 25-355 Indywidualna Specjalistyczna Praktyka Lekarska Maciej ZymlaKnurow, Poland, 44-190 Szpital W Knurowie Sp. Z O.O.Knurow, Poland, 44-190 Centrum Badan Klinicznych JciKrakow, Poland, 30-348 Marta Dagmara Banach Marta Banach Specjalistyczny Gabinet NeurologicznyKrakow, Poland, 30-539 Centrum Medyczne EvitaKrakow, Poland, 31-153 Szpital Specjalistyczny Im. Ludwika Rydygiera W Krakowie Sp. Z O.O.Krakow, Poland, 31-826 Centrum Medyczne Szpital Swietej Rodziny Sp Z O.O.Lodz, Poland, 90-302 Pracownia Endoskopii Centrum Medyczne Szpital Swietej Rodziny Sp Z O.O.Lodz, Poland, 90-302 Medical Magnus ClinicLodz, Poland, 90-552 Wojewodzki Szpital Specjalistyczny Im. Bieganskiego W LodziLodz, Poland, 91-347 Gastromed Sp. Z O.O.Lublin, Poland, 20-582 Ai Centrum Medyczne Sp. Z O.O. Sp.K.Poznan, Poland, 61-113 Korczowski Bartosz Gabinet LekarskiRzeszow, Poland, 35-302 Endoskopia Sp. Z O. O.Sopot, Poland, 81-756 Szpital Sredzki Serca Jezusowego Sp. Z O.O.Sroda Wielkopolska, Poland, 63-000 Ez-Med Sp. Z O.O. Sp.K.Swidnica, Poland, 58-100 Pracownia Endoskopii Szpital MswSzczecin, Poland, 70-001 Twoja Przychodnia Szczecinskie Centrum MedyczneSzczecin, Poland, 71-434 Gastromed Kopon, Zmudzinski I Wspolnicy Sp.J.Torun, Poland, 87-100 Centrum Zdrowia MdmWarszawa, Poland, 00-635 Wip Warsaw Ibd Point Profesor KierkusWarszawa, Poland, 00-728 Endoterapia Pfg Sp. Z O.O.Warszawa, Poland, 02-653 Centrum Diagnostyczno-Lecznicze Barska Sp. Z O. O.Wloclawek, Poland, 87-800 Melita Medical Sp. Z O.O.Wroclaw, Poland, 50-449 Centrum Gastrologiczno HepatologiczneWroclaw, Poland, 50-555 Planetmed Sp. Z.O.O.Wroclaw, Poland, 52-210 LexmedicaWroclaw, Poland, 53-114 Russian Federation, Sestroretsk Spb Sbih \"City Hospital #40 Of The Kurortnyi Region\"Saint-Petersburg, Sestroretsk, Russian Federation, 197706 Russian Federation Llc \"Alliance Biomedical-Ural Group\"Izhevsk, Russian Federation, 426061 Clinic Of Fsbei He Ksmu Moh RfKrasnodar, Russian Federation, 350072 Llc \"Olla-Med\"Moscow, Russian Federation, 105554 Sechenov University On The Base Of Institute Of Translational Medicine And BiotechnologyMoscow, Russian Federation, 119435 Limited Liability Company \"Medical Center Sibnovomed\"Novosibirsk, Russian Federation, 630005 Federal State Budgetary Scientific Institution \"Scientific Research Institute Of Physiology AndNovosibirsk, Russian Federation, 630117 Clinic At Fsbei He \"Omsk State Medical University\" Moh RfOmsk, Russian Federation, 644050 Llc \"New Clinic\"Pyatigorsk, Russian Federation, 357500 Limited Liability Company \"Riat\"Saint-Petersburg, Russian Federation, 195220 Saint-Petersburg State Budgetary Healthcare Institution \"City Hospital #26\"Saint-Petersburg, Russian Federation, 196247 Private Institution Educational Organization Of Higher EducationSamara, Russian Federation, 443011 Non-State Healthcare Institution 'Railway Clinical Hospital At Samara Station Of Open Joint StockSamara, Russian Federation, 443029 Limited Liability Company Medical Company \"Hepatolog\"Samara, Russian Federation, 443093 Saint-Petersburg State Budgetary Healthcare Institution \"City Clinical Hospital Of The RighteousSt. Petersburg, Russian Federation, 197706|Tychy, Silesia, Poland, 43-100|Riyadh, Saudi Arabia, 11426 King Khalid University HospitalRiyadh, Saudi Arabia, 11472|Zemun, Beograd, Serbia, 11080|Beograd, Serbia, 11000 Vojnomedicinska Akademija, Klinika Za Gastroenterologiju I HepatologijuBeograd, Serbia, 11000 Kbc \"Dr Dragisa Misovic-Dedinje\"Beograd, Serbia, 11040 Klinicko Bolnicki Centar Zemun, Klinika Za Internu Medicinu,Zemun, Beograd, Serbia, 11080|Beograd, Srbija, Serbia, 11000 Klinicki Centar KragujevacKragujevac, Srbija, Serbia, 34000 Klinicki Centar NisNis, Srbija, Serbia, 18000 Opsta Bolnica SuboticaSubotica, Srbija, Serbia, 24000 Opsta Bolnica \"Djordje Joanovic\", Odeljenje Interno, Odsek GastroenterologijaZrenjanin, Srbija, Serbia, 23000|Banska Bystrica, Slovakia, 975 17 Breznianske Centrum Gastroenterologie S.R.O.Brezno, Slovakia, 97701 Km Management Spol. S.R.O.Nitra, Slovakia, 949 01 Accout Center S.R.O. Gastroenterologicka AmbulanciaSahy, Slovakia, 936 01 Endomed, S.R.O.Vranov Nad Toplou, Slovakia, 093 01|Lenasia, Gauteng, South Africa, 1827 Wits Clinical Research Trial SiteParktown, Gauteng, South Africa, 2193 Wits Clinical Reasearch - Wits Bara Clinical Trial SiteSoweto, Gauteng, South Africa, 2013|Claremont, Western Cape, South Africa, 7708|Santander, Cantabria, Spain, 39008|Madrid, Spain, 28034 Hospital Universitario Virgen Del RocioSevilla, Spain, 41013 Hospital Universitari I Politecnic La FeValencia, Spain, 46026|ZÃ¼rich, Switzerland, Ch-8091|Tunis, Tunisia, 1007 Habib Thameur HospitalTunis, Tunisia, 1008|Ankara, Turkey, 06100 Ankara Universitesi Tip Fakultesi, Ibn-I Sina HastanesiAnkara, Turkey, 06100 Hacettepe Universitesi Tip FakultesiAnkara, Turkey, 06230 Bezmialem Vakif Universitesi Tip Fakultesi HastanesiIstanbul, Turkey, 34093 Istanbul Universitesi Cerrahpasa Tip FacultesiIstanbul, Turkey, 34098 Istanbul Universitesi Cerrahpasa Tip FakultesiIstanbul, Turkey, 34098 Erciyes Universitesi Tip FakultesiKayseri, Turkey, 38039 Kocaeli Universitesi Tip FakultesiKocaeli, Turkey, 41380 Mersin Universitesi Tip Fakultesi Hastanesi, Ic HastaliklariMersin, Turkey, 33110 Mersin Universitesi Tip Fakultesi HastanesiMersin, Turkey, 33110 Karadeniz Teknik Universitesi Tip Fakultesi, Ic HastaliklariTrabzon, Turkey, 61080 Karadeniz Teknik Universitesi Tip FakultesiTrabzon, Turkey, 61080 Bulent Ecevit Universitesi Tip FakultesiZonguldak, Turkey, 67600|Chernivtsi, Ukraine, 58001 Regional Municipal Institution \"Chernivtsi Regional Clinical Hospital\", Surgery DepartmentChernivtsi, Ukraine, 58001 Municipal Healthcare Institution Kharkiv City Clinical Hospital #2 N.A. Prof. O.O. ShalimovKharkiv, Ukraine, 61037 Private Enterprise Of Private Manufacturing Company \"Acinus\", Medical And Diagnostic CenterKropyvnytskyi, Ukraine, 25006 Kyiv Municipal Clinical Hospital #18, Proctology DepartmentKyiv, Ukraine, 01030 Med Centre 'Ok!Clinic+'Kyiv, Ukraine, 02091 Medical Center \"Ok Clinic+\" Of International Institute Of Clinical TrialsKyiv, Ukraine, 02091 Medical Center \"Universal Clinic Oberig\" Of \"Kapital\" Llc, Gastro CenterKyiv, Ukraine, 03680 Lviv Clinical Hospital On Railway Transport Of Health Care Center Branch Of Pjsc Ukrainian RailwayLviv, Ukraine, 79007 Vinnytsia City Clinical Hospital No.1Vinnytsia, Ukraine, 21000 Private Small-Scale Enterprise Medical Center \"Pulse\"Vinnytsia, Ukraine, 21001 Vinnytsia Regional Clinical Hospital For War VeteransVinnytsia, Ukraine, 21005 Vinnytsia Regional Clinical Hospital N.A. M.I.PyrohovVinnytsia, Ukraine, 21018|Abu Dhabi, United Arab Emirates, 112412 Al|Dothan, Alabama, United States, 36301 Gut P.C., Dba Digestive Health Specialists Of The SoutheastDothan, Alabama, United States, 36305|Beverly Hills, California, United States, 90210 Long Beach Clinical Trial Services, Inc.Long Beach, California, United States, 90806 Entertainment Medical GroupLos Angeles, California, United States, 90036 Gastrointestinal Biosciences Clinical Trials, LlcLos Angeles, California, United States, 90067 Alliance Clinical Research, LlcPoway, California, United States, 92064|Colorado Springs, Colorado, United States, 80903 Peak Gastroenterology AssociatesColorado Springs, Colorado, United States, 80907|Clearwater, Florida, United States, 33756-3839 West Coast Endoscopy CenterClearwater, Florida, United States, 33756 Gastro FloridaClearwater, Florida, United States, 33762 Uf Health Jacksonville - Gastroenterology EmersonJacksonville, Florida, United States, 32207 Uf Health Jacksonville - Faculty ClinicJacksonville, Florida, United States, 32209 University Of Miami Clinical Research BuildingMiami, Florida, United States, 33136 University Of Miami Crohn'S And Colitis CenterMiami, Florida, United States, 33136 University Of Miami Hospital And ClinicsMiami, Florida, United States, 33136 University Of Miami HospitalMiami, Florida, United States, 33136 Millenia Surgery CenterOrlando, Florida, United States, 32811 Hmd Research LlcOrlando, Florida, United States, 32819|Boise, Idaho, United States, 83706 Idaho Gastroenterology AssociatesMeridian, Idaho, United States, 83642|Shawnee Mission, Kansas, United States, 66217|Houma, Louisiana, United States, 70360 Gulf Coast Surgical CenterHouma, Louisiana, United States, 70360 The Hearing Center (Audiology)Houma, Louisiana, United States, 70360|Chevy Chase, Maryland, United States, 20815 Mgg Group Co., Inc., Chevy Chase Clinical ResearchChevy Chase, Maryland, United States, 20815 Capitol ResearchRockville, Maryland, United States, 20850|Boston, Massachusetts, United States, 02115 Mass Eye And Ear, LongwoodBoston, Massachusetts, United States, 02115 Brigham And Women'S HospitalBoston, Massachusetts, United States, 02215 Brigham And Women'S HospitalChestnut Hill, Massachusetts, United States, 02467 Umass Memorial Medical CenterWorcester, Massachusetts, United States, 01655 University Of Massachusetts Medical SchoolWorcester, Massachusetts, United States, 01655|Caro, Michigan, United States, 48723 Clinical Research Institute Of Michigan, LlcChesterfield, Michigan, United States, 48047 Eastside Endoscopy CenterMacomb, Michigan, United States, 48044 Eastside Endoscopy CenterSaint Clair Shores, Michigan, United States, 48081|Ocean Springs, Mississippi, United States, 39564|New York, New York, United States, 10021 Weill Cornell Medical CollegeNew York, New York, United States, 10021 New York Presbyterian Hospital - Weill Cornell Medical College (Colonoscopy)New York, New York, United States, 10065 New York Presbyterian Hospital - Weill Cornell Medical College Investigational PharmacyNew York, New York, United States, 10065 Weill Cornell Medical College - New York Presbyterian Hospital (Endoscopy Suite)New York, New York, United States, 10065 Weill Cornell Medical College - New York Presbyterian HospitalNew York, New York, United States, 10065 Digiovanna Institute For Medical Education And ResearchNorth Massapequa, New York, United States, 11758-1853|Chapel Hill, North Carolina, United States, 27514 Unc Hospitals Endoscopy Center At MeadowmontChapel Hill, North Carolina, United States, 27517 University Of North Carolina At Chapel HillChapel Hill, North Carolina, United States, 27599 Gastroenterology Associates Of The Piedmont, PaWinston-Salem, North Carolina, United States, 27103 Pmg Research Of Winston-Salem, LlcWinston-Salem, North Carolina, United States, 27103|Oklahoma City, Oklahoma, United States, 73112|Kingsport, Tennessee, United States, 37660 Holston Valley Surgery CenterKingsport, Tennessee, United States, 37660 Vanderbilt University Medical CenterNashville, Tennessee, United States, 37212-1375 Vanderbilt University Medical CenterNashville, Tennessee, United States, 37212-1610 Vanderbilt University Medical Center - Gi Endoscopy LabNashville, Tennessee, United States, 37232-5543 Vanderbilt University Medical CenterNashville, Tennessee, United States, 37232-7610 Vanderbilt University Medical Center - Gi Research RegulatoryNashville, Tennessee, United States, 37232|Arlington, Texas, United States, 76012 Envision Imaging (Cxr)Arlington, Texas, United States, 76012 Texas Clinical Research Institiute, LlcArlington, Texas, United States, 76012 First Street HospitalBellaire, Texas, United States, 77401 Pearland Surgery CenterHouston, Texas, United States, 77047 Lonestar Endoscopy, LlpSouthlake, Texas, United States, 76092 Texas Digestive Disease ConsultantsSouthlake, Texas, United States, 76092|Fairfax, Virginia, United States, 22031","Alabama|California|Colorado|Florida|Idaho|Kansas|Louisiana|Maryland|Massachusetts|Michigan|Mississippi|New York|North Carolina|Oklahoma|Tennessee|Texas|Virginia","Australia|Austria|Belgium|Bosnia And Herzegovina|Canada|Croatia|Czechia|France|Georgia|Germany|Hungary|Italy|Kuwait|Lebanon|Poland|Saudi Arabia|Serbia|Slovakia|South Africa|Spain|Switzerland|Tunisia|Turkey|Ukraine|United Arab Emirates|United States","New South Wales Concord Repatriation General Hospital|Queensland Mater Misericordiae Ltd|Saint John Of God Health Care Inc.|Victoria Ballarat Base Hospital|Akh Wien Universitaetsklinik Fuer Innere Medizin Iii|University Hospital Brussels|Javna Zdravstvena Ustanova Univerzitetski Klinicki Centar Republike Srpske,|Manitoba Winnipeg Regional Health Authority - Health Sciences Centre, Winnipeg|Ontario HÃ´pital Montfort|Quebec Rocklandmd|Hrvatska Klinicki Bolnicki Centar Sestre Milosrdnice|Klinicki Bolnicki Centar Rijeka, Odjel Za Gastroenterologiju|Lekarna Altea|Hospital|The First University Clinic Of Tsmu|Paian Med Research Gmbh|Bekes Megyei Kozponti Korhaz, Rethy Pal Tagkorhaz|A.O.U. Policlinico G. Martino|Bari Irccs Saverio De Bellis|Bs A.O.Spedali Civili|Cz Univ. \"Magna Graecia\" Di Catanzaro|Mb Asst Monza|Milan Istituto Clinico Humanitas Irccs - Ibd Center|Milano Asst Rhodense - Ospedale Di Circolo Di Rho|Hospital - Dubai|Saint George Hospital University Medical Center|Niepubliczny Zaklad Opieki Zdrowotnej All-Medicus|Silesia H-T. Centrum Medyczne-Endoterapia|King Abdulaziz Medical City|Beograd Klinicko Bolnicki Centar \"Bezanijska Kosa\"|Klinicko Bolnicki Centar Zvezdara, Klinika Za Interne Bolesti,|Srbija Klinicki Centar Srbije, Klinika Za Gastroenterohepatologiju|Fakultna Nemocnica S Poliklinikou F.D. Roosevelta Banska Bystrica|, Gauteng Lenasia Clinical Trial Centre|, Western Cape Dr Wright Private Practice|Cantabria Hospital Universitario Marques De Valdecilla|Hospital Universitario Ramon Y Cajal|UniversitÃ¤tsspital ZÃ¼rich|La Rabta Hospital|Ankara Universitesi Tip Fakultesi, Ibn-I Sina Hastanesi, Ic Hastaliklari Anabilim Dali,|Regional Municipal Institution \"Chernivtsi Regional Clinical Hospital\", Gastroenterology Department,|Cleveland Clinica Abu Dhabi, Department Of Gastroenterology And Hepatology|Dothan Surgery Center|Brighton Surgical Center|Front Range Endoscopy Center|Gastro Florida|Treasure Valley Medical Research|Westglen Gastrointestinal Consultants, P.A.|Cronola, Llc|Chevy Chase Endoscopy Center|Brigham And Women's Hospital|Caro Health Plaza|Digestive Health Center|Weill Cornell Medical College (Clinical Site)|Unc Hospitals|Digestive Disease Specialists, Inc.|Holston Medical Group|Cross Timbers Surgery Center L.P. (Colonoscopy)|Verity Research, Inc.",{"$nulls":3},"Pfizer CT.gov Call Center","2020-03-25","2020-05-25T16:36:06.349","2020-05-26T17:10:42.972","NCT03395184"]
["5ecbf3f6feab101b1553083e","NCT03395184","2020-04-08","Pfizer","PFE","Recruiting","Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PFâ€‘06700841 In Subjects With Moderate To Severe Crohn's Disease","Brepocitinib|Pf-06651600","JAK1 Inhibitor|TYK2 Inhibitor|JAK1 Inhibitor|JAK3 Inhibitor","Yes","['Brepocitinib', 'Pf-06651600']","Yes","['TYK2 Inhibitor', 'JAK3 Inhibitor']","Phase 2",2,250,"Anticipated","2018-02-02","2022-11-30","DAS","Disease Activity Score",{"$nulls":3},"The objectives of this study are to evaluate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-06651600 (200 mg for 8 weeks followed by 50 mg for 4 weeks) dosed once daily and PF-06700841 (60 mg for 12 weeks) dosed once daily during an induction period of 12 weeks, followed by an open label extension period at doses of 50 mg and 30 mg of PF 06651600 and PF 06700841, respectively, for 52 weeks.",null,"A PHASE 2A, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ORAL PF-06651600 AND PF-06700841 AS INDUCTION AND OPEN LABEL EXTENSION TREATMENT IN SUBJECTS WITH MODERATE TO SEVERE CROHN'S DISEASE","B7981007","Crohn's Disease","Crohn Disease","Gastrointestinal Diseases","Gastrointestinal","Experimental","PF-06700841 or placebo|PF-06651600 or placebo",null,"Drug","Placebo PF-06700841|PF-06700841|Placebo PF-06651600|PF-06651600","12 weeks, followed by PF-06700841, 30 mg QD for 52 weeks.|60 mg QD for 12 weeks followed by 30 mg QD for up to 52 weeks|12 weeks, followed by PF-06651600, 50 mg QD for 52 weeks|200 mg QD for 8 weeks, followed by 50 mg QD up to 56 weeks",null,"PF-06700841 or placebo|PF-06651600 or placebo","\n\n 1. Male and/or female subjects 18 years to 75 years of age\n 2. Documented diagnosis of ileal, ileocolonic, or colonic CD with a minimum disease duration of 3 months, as determined by endoscopic and histopathology assessment.\n 3. Endoscopic confirmation of active disease with total SES CD total score of at least 7. For isolated ileal disease, SES CD total score should be at least 4.\n 4. An average daily liquid/soft stool frequency (SF) greater than or equal to 2.5 or daily abdominal pain (AP) greater than or equal to 2.0.\n 5. Must have inadequate response to, loss of response to, or intolerance to at least one conventional therapy for CD:â€¢Steroids; Immunosuppressants (azathioprine [AZA], 6 MP, or methotrexate [MTX]); Anti TNF inhibitors (infliximab, adalimumab,certolizumab); Anti integrin inhibitors (eg, vedolizumab); Anti IL 12/23 inhibitor (ustekinumab).\n    \n    \n 6. Subjects currently receiving the following treatment for CD are eligible providing they have been on stable doses as described below: * Oral corticosteroids (prednisone or equivalent up to 25 mg/day; budesonide up to 9 mg/day). Stable dose for at least 2 weeks prior to baseline. If oral corticosteroids have been recently discontinued, they must have been stopped at least 2 weeks prior to baseline. Decreases in steroid use due to AEs are allowed.\n     * Oral 5 ASA or sulfasalazine are allowed providing that the dose is stable for at least 4 weeks prior to baseline.\n     * Crohn's disease related antibiotics are allowed providing that the dose is stable for at least 4 weeks prior to baseline. If antibiotics are stopped prior to baseline, they must be discontinued at least 4 days prior to baseline.\n    \n    \n\n","\n\n 1.  Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, diverticular disease, ulcerative colitis (UC), or clinical findings suggestive of UC.\n 2.  Presence of active (draining) fistulae or intra abdominal or perineal abscesses.\n 3.  Strictures with obstructive symptoms.\n 4.  Short bowel syndrome.\n 5.  History of bowel perforation requiring surgical intervention within the past 12 months.\n 6.  Previous bowel surgery resulting in an existing stoma. Subjects who have a j pouch are excluded, as a j pouch can result in a stoma.\n 7.  History of bowel surgery within 6 months prior to baseline.\n 8.  Subjects displaying clinical signs of fulminant colitis or toxic megacolon.\n 9.  Subjects with primary sclerosing cholangitis.\n 10. Subjects with evidence of colonic adenomas, dysplasia or neoplasia.\n 11. Abnormal findings on the chest x ray film such as presence of tuberculosis (TB), general infections, heart failure, or malignancy.\n 12. Any history of either untreated or inadequately treated latent or active TB infection, current treatment for active or latent TB infection or evidence of currently active TB by chest x ray, residing with or frequent close contact with individual(s) with active TB.\n 13. Subjects receiving the following therapies within the time period described below or expected to receive any of these therapies during the study period: 1.  >9 mg/day of oral budesonide or >25 mg/day of prednisone or equivalent oral systemic corticosteroid dose within 2 weeks prior to baseline.\n      2.  IV, IM (parenteral), or topical (rectal) treatment of 5 ASA or corticosteroid enemas/suppositories within 2 weeks prior to baseline.\n      3.  Azathioprine, 6 mercaptopurine, or methotrexate within 2 weeks prior to baseline.\n      4.  Anti TNF inhibitors (or biosimilars thereof) as described below: * Infliximab within 8 weeks prior to baseline;\n           * Adalimumab within 8 weeks prior to baseline;\n           * Certolizumab within 8 weeks prior to baseline;\n          \n          \n      5.  Anti integrin inhibitors (eg, vedolizumab) within 8 weeks prior to baseline.\n      6.  Ustekinumab within 8 weeks prior to baseline.\n      7.  Interferon therapy within 8 weeks prior to baseline.\n      8.  Subjects with prior treatment with lymphocyte depleting agents/therapies within 1 year prior to baseline (eg, CamPath[alemtuzumab], alkylating agents [eg, cyclophosphamide or chlorambucil], total lymphoid irradiation, etc).\n      9.  Subjects who have received rituximab or other selective B lymphocyte depleting agents within 1 year prior to baseline.\n      10. Subjects previously receiving leukocyte apheresis, including selective lymphocyte, monocyte, or granulocyte apheresis, or plasma exchange within 6 months prior to baseline.\n      11. Other marketed immunosuppressants or biologics with immunomodulatory properties within 3 months prior to baseline.\n      12. Subjects who have received other JAK inhibitors within 3 months prior to baseline.\n      13. Subjects who have not responded to or have been intolerant of other JAK inhibitors.\n      14. Other investigational procedures(s) or product(s), such as immunosuppressants used in transplantation (eg, mycophenolate mofetil, cyclosporine, rapamycin, or tacrolimus) or live (attenuated) vaccine within 30 days prior to baseline.","TNF","tumor necrosis factor","Protein","Lung, Breast, Ovary","Actual","2018-01-10","Actual","Anticipated","2022-11-30","Anticipated","2020-04-01","2017-12-05","2018-01-03","2020-04-07","Yes",null,"Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years","75 Years","All",null,"No","Yes\nPfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",null,"URL: https://pmiform.com/clinical-trial-info-request?StudyID=B7981007 [https://pmiform.com/clinical-trial-info-request?StudyID=B7981007] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To obtain contact information for a study center near you, click here.",null,"Yes","No",{"$nulls":17},"2017-003359-43|PIZZICATO","EudraCT Number|Alias Study Number","Proportion of subjects achieving clinically meaningful endoscopic improvement (reduction of more than or equal to 3 points from baseline in Simplified Endoscopic Activity Score for Crohn's Disease (SES-CD) at Week 12|Number of subjects with adverse events|Number of subjects with serious adverse events|Number of subjects with electrocardiogram findings of potential clinical importance|Number of subjects with laboratory tests findings of potential clinical importance|Number of subjects withdrawal due to adverse events|Number of subjects with vital signs findings of potential clinical importance","12 weeks|Baseline of extension period (Week 12) to week 68",null,"Number of participants with potentially clinically important serious infections findings|Mean change from baseline in SES-CD score at Week 12.|Proportion of subjects achieving SES-CD 25 and SES-CD 50 at Week 12.|Proportion of subjects achieving endoscopic remission (SES-CD less than or equal to 2) at Week 12.|Proportion of subjects achieving mucosal healing at Week 12.|Number of subjects with adverse events|Number of subjects with serious adverse events|Number of subjects with electrocardiogram findings of potential clinical importance.|Number of subjects withdrawal due to adverse events|Number of subjects with vital signs findings of potential clinical importance.|Number of subjects with laboratory tests findings of potential clinical importance.|Proportion of subjects achieving SES CD 25 and SES CD 50 at Week 64 among subjects who achieved SES CD 25 and SES CD 50 at week 12 respectively.|Proportion of subjects achieving clinically meaningful endoscopic improvement (CMEI response) at week 64 among subjects who achieved CMEI response at Week 12.","64 weeks|Baseline, week 12|Number of subjects achieving SES-CD 25 and SES-CD 50 at Week 12.|Number of subjects achieving endoscopic remission (SES-CD less than or equal to 2) at Week 12.|Number of subjects achieving mucosal healing at Week 12.|Number of participants with reported adverse events|Number of participants with reported serious adverse events|Number of participants with potentially clinically important electrocardiogram findings.|Number of subjects withdrawal due to adverse events.|Number of participants with potentially clinically important vital signs findings.|Number of participants with potentially clinically important laboratory findings.|Number of subjects achieving SES-CD 25 and SES-CD 50 at Week 64 among subjects who achieved SES CD 25 and SES CD 50 at week 12|Number of subject achieving clinically meaningful endoscopic improvement (CMEI response) at week 64 among subjects who achieved CMEI response at week 12.","Baseline, week 12|Week 12|Baseline of induction period to week 12|week 64","ClinicalTrials.gov_Inquiries@pfizer.com","Pfizer CT.gov Call Center","1-800-718-1021","Concord, New South Wales, Australia, 2139|South Brisbane, Queensland, Australia, 4101|Subiaco, Western|[Active, Not Recruiting]Ballarat, Victoria, Australia, 3350|Wien, Austria, 1090|Jette, Belgium, 1090 University Hospitals LeuvenLeuven, Belgium, 3000 Chc - Saint-JosephLiÃ¨ge, Belgium, 4000|Banja Luka, Bosnia And Herzegovina, 78000 Sveucilisna Klinicka Bolnica Mostar,Mostar, Bosnia And Herzegovina, 88000|Winnipeg, Manitoba, Canada, R3A 1R9|Ottawa, Ontario, Canada, K1K 0T2|Mont-Royal, Quebec, Canada, H3P 2V9 Cmiim (Le Centre Des Maladies Inflammatoires Et Intestinales De Montreal)Mont-Royal, Quebec, Canada, H3P 3E5 Ciusss De L'Est-De-L'Ile-De-Montreal Installation Hopital Maisonneuve-RosemontMontreal, Quebec, Canada, H1T 2M4|Zagreb, Hrvatska, Croatia, 10000|Rijeka, Croatia, 51000 Klinicki Bolnicki Centar Split, Zavod Za GastroenterologijuSplit, Croatia, 21000 Opca Bolnica Zadar, Odjel Za GastroenterologijuZadar, Croatia, 23000 Klinicka Bolnica Dubrava ZagrebZagreb, Croatia, 10000 Klinicki Bolnicki Centar Zagreb, Zavod Za Gastroenterologiju I HepatologijuZagreb, Croatia, 10000|Bilina, Czechia, 41801 Nemocnice Horovice, A.S.Horovice, Czechia, 268 31 Hepato-Gastroenterologie Hk S.R.O.Hradec Kralove, Czechia, 500 12 Medialpharma S.R.O.Hradec Kralove, Czechia, 500 12 Gastroenterologicka Ambulance A EndoskopieMost, Czechia, 43401 Vseobecna Fakultni NemocnicePraha 2, Czechia, 128 08 VÅ¡eobecnÃ¡ FakultnÃ­ Nemocnice V PrazePraha 2, Czechia, 128 08 Lekarna Sv. AnnaPraha 3, Czechia, 130 00 Egk S.R.O. - Sanatorium Sv. AnnyPraha 3, Czechia, 13000 Fakultni Nemocnice V MotolePraha 5, Czechia, 150 06 FakultnÃ­ Nemocnice V MotolePraha 5, Czechia, 150 06 Nemocnice Strakonice, A.S., Interni OddeleniStrakonice, Czechia, 386 01 Nemocnice Strakonice, A.S.Strakonice, Czechia, 386 29|Achrafieh, Beirut, Lebanon|Tbilisi, Georgia, 0141 Institute Of Clinical Cardiology, Ltd.Tbilisi, Georgia, 0159 David Tatishvili Medical CenterTbilisi, Georgia, 0186|Berlin, Germany, 10318 Krankenhaus Waldfriede E.V.,Berlin, Germany, 14163 Universitaetsklinikum BonnBonn, Germany, 53127 Universitaetsklinikum Schleswig-HolsteinKiel, Germany, 24105 UniversitÃ¤tsklinikum Giessen Und Marburg GmbhMarburg, Germany, 35043|Bekescsaba, Hungary, 5600 Semmelweis Egyetem, Ii. Belgyogyaszati KlinikaBudapest, Hungary, 1088 Szent Janos Korhaz Es Eszak-Budai Egyesitett Korhazak[Active, Not Recruiting]Budapest, Hungary, 1125 Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz, Endoszkopos LaboratoriumGyula, Hungary, 5700 Clinfan Szolgaltato Kft.Szekszard, Hungary, 7100 Csolnoky Ferenc Korhaz Belgyogyaszati Centrum I. Belgyogyaszati OsztalyVeszprem, Hungary, 8200|Messina, Italy, 98125 Aou Policlinico Di ModenaModena, Italy, 41124 Azienda Ospedaliera Di PadovaPadova, Italy, 35128 Policlinico Universitario Campus Bio-MedicoRoma, Italy, 00128 Policlinico Gemelli/Complesso Integrato ColumbusRome, Italy, 00168 Korea, Republic Of, Korea Kyungpook National University HospitalDaegu, Korea, Korea, Republic Of, 41944 Korea, Republic Of Kyung Hee University HospitalSeoul, Korea, Republic Of, 02447 Kangbuk Samsung HospitalSeoul, Korea, Republic Of, 03181 Severance Hospital, Yonsei University Health SystemSeoul, Korea, Republic Of, 03722 The Catholic University Of Korea, Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591|Castellana Grotte, Bari, Italy, 70013|Brescia, Bs, Italy, 25123|Catanzaro, Cz, Italy, 88100|Monza, Mb, Italy, 20090|Rozzano, Milan, Italy, 20089|Rho, Milano, Italy, 20017|Dubai, United Arab Emirates, 22241 Emirates Specialty HospitalDubai, United Arab Emirates, Po Box 505240|Achrafieh, Lebanon American University Of Beirut Medical CenterBeirut, Lebanon Ain Wazein Medical VillageEl Chouf, Lebanon Centre Hospitalier Universitaire Notre Dame De SecoursJbeil, Lebanon Hammoud Hospital University Medical CenterSaida, Lebanon|Katowice, Poland, 40-659 Etg KielceKielce, Poland, 25-355 Indywidualna Specjalistyczna Praktyka Lekarska Maciej ZymlaKnurow, Poland, 44-190 Szpital W Knurowie Sp. Z O.O.Knurow, Poland, 44-190 Centrum Badan Klinicznych JciKrakow, Poland, 30-348 Marta Dagmara Banach Marta Banach Specjalistyczny Gabinet NeurologicznyKrakow, Poland, 30-539 Centrum Medyczne EvitaKrakow, Poland, 31-153 Szpital Specjalistyczny Im. Ludwika Rydygiera W Krakowie Sp. Z O.O.Krakow, Poland, 31-826 Centrum Medyczne Szpital Swietej Rodziny Sp Z O.O.Lodz, Poland, 90-302 Pracownia Endoskopii Centrum Medyczne Szpital Swietej Rodziny Sp Z O.O.Lodz, Poland, 90-302 Medical Magnus ClinicLodz, Poland, 90-552 Wojewodzki Szpital Specjalistyczny Im. Bieganskiego W LodziLodz, Poland, 91-347 Gastromed Sp. Z O.O.Lublin, Poland, 20-582 Ai Centrum Medyczne Sp. Z O.O. Sp.K.Poznan, Poland, 61-113 Korczowski Bartosz Gabinet LekarskiRzeszow, Poland, 35-302 Endoskopia Sp. Z O. O.Sopot, Poland, 81-756 Szpital Sredzki Serca Jezusowego Sp. Z O.O.Sroda Wielkopolska, Poland, 63-000 Ez-Med Sp. Z O.O. Sp.K.Swidnica, Poland, 58-100 Pracownia Endoskopii Szpital MswSzczecin, Poland, 70-001 Twoja Przychodnia Szczecinskie Centrum MedyczneSzczecin, Poland, 71-434 Gastromed Kopon, Zmudzinski I Wspolnicy Sp.J.Torun, Poland, 87-100 Centrum Zdrowia MdmWarszawa, Poland, 00-635 Wip Warsaw Ibd Point Profesor KierkusWarszawa, Poland, 00-728 Endoterapia Pfg Sp. Z O.O.Warszawa, Poland, 02-653 Centrum Diagnostyczno-Lecznicze Barska Sp. Z O. O.Wloclawek, Poland, 87-800 Melita Medical Sp. Z O.O.Wroclaw, Poland, 50-449 Centrum Gastrologiczno HepatologiczneWroclaw, Poland, 50-555 Planetmed Sp. Z.O.O.Wroclaw, Poland, 52-210 LexmedicaWroclaw, Poland, 53-114 Russian Federation, Sestroretsk Spb Sbih \"City Hospital #40 Of The Kurortnyi Region\"Saint-Petersburg, Sestroretsk, Russian Federation, 197706 Russian Federation Llc \"Alliance Biomedical-Ural Group\"Izhevsk, Russian Federation, 426061 Clinic Of Fsbei He Ksmu Moh RfKrasnodar, Russian Federation, 350072 Llc \"Olla-Med\"Moscow, Russian Federation, 105554 Sechenov University On The Base Of Institute Of Translational Medicine And BiotechnologyMoscow, Russian Federation, 119435 Limited Liability Company \"Medical Center Sibnovomed\"Novosibirsk, Russian Federation, 630005 Federal State Budgetary Scientific Institution \"Scientific Research Institute Of Physiology AndNovosibirsk, Russian Federation, 630117 Clinic At Fsbei He \"Omsk State Medical University\" Moh RfOmsk, Russian Federation, 644050 Llc \"New Clinic\"Pyatigorsk, Russian Federation, 357500 Limited Liability Company \"Riat\"Saint-Petersburg, Russian Federation, 195220 Saint-Petersburg State Budgetary Healthcare Institution \"City Hospital #26\"Saint-Petersburg, Russian Federation, 196247 Private Institution Educational Organization Of Higher EducationSamara, Russian Federation, 443011 Non-State Healthcare Institution 'Railway Clinical Hospital At Samara Station Of Open Joint StockSamara, Russian Federation, 443029 Limited Liability Company Medical Company \"Hepatolog\"Samara, Russian Federation, 443093 Saint-Petersburg State Budgetary Healthcare Institution \"City Clinical Hospital Of The RighteousSt. Petersburg, Russian Federation, 197706|Tychy, Silesia, Poland, 43-100|Riyadh, Saudi Arabia, 11426 King Khalid University HospitalRiyadh, Saudi Arabia, 11472|Zemun, Beograd, Serbia, 11080|Beograd, Serbia, 11000 Vojnomedicinska Akademija, Klinika Za Gastroenterologiju I HepatologijuBeograd, Serbia, 11000 Kbc \"Dr Dragisa Misovic-Dedinje\"Beograd, Serbia, 11040 Klinicko Bolnicki Centar Zemun, Klinika Za Internu Medicinu,Zemun, Beograd, Serbia, 11080|Beograd, Srbija, Serbia, 11000 Klinicki Centar KragujevacKragujevac, Srbija, Serbia, 34000 Klinicki Centar NisNis, Srbija, Serbia, 18000 Opsta Bolnica SuboticaSubotica, Srbija, Serbia, 24000 Opsta Bolnica \"Djordje Joanovic\", Odeljenje Interno, Odsek GastroenterologijaZrenjanin, Srbija, Serbia, 23000|Banska Bystrica, Slovakia, 975 17 Breznianske Centrum Gastroenterologie S.R.O.Brezno, Slovakia, 97701 Km Management Spol. S.R.O.Nitra, Slovakia, 949 01 Accout Center S.R.O. Gastroenterologicka AmbulanciaSahy, Slovakia, 936 01 Endomed, S.R.O.Vranov Nad Toplou, Slovakia, 093 01|Lenasia, Gauteng, South Africa, 1827 Wits Clinical Research Trial SiteParktown, Gauteng, South Africa, 2193 Wits Clinical Reasearch - Wits Bara Clinical Trial SiteSoweto, Gauteng, South Africa, 2013|Claremont, Western Cape, South Africa, 7708|Santander, Cantabria, Spain, 39008|Madrid, Spain, 28034 Hospital Universitario Virgen Del RocioSevilla, Spain, 41013 Hospital Universitari I Politecnic La FeValencia, Spain, 46026|ZÃ¼rich, Switzerland, Ch-8091|Tunis, Tunisia, 1007 Habib Thameur HospitalTunis, Tunisia, 1008|Ankara, Turkey, 06100 Ankara Universitesi Tip Fakultesi, Ibn-I Sina HastanesiAnkara, Turkey, 06100 Hacettepe Universitesi Tip FakultesiAnkara, Turkey, 06230 Bezmialem Vakif Universitesi Tip Fakultesi HastanesiIstanbul, Turkey, 34093 Istanbul Universitesi Cerrahpasa Tip FacultesiIstanbul, Turkey, 34098 Istanbul Universitesi Cerrahpasa Tip FakultesiIstanbul, Turkey, 34098 Erciyes Universitesi Tip FakultesiKayseri, Turkey, 38039 Kocaeli Universitesi Tip FakultesiKocaeli, Turkey, 41380 Mersin Universitesi Tip Fakultesi Hastanesi, Ic HastaliklariMersin, Turkey, 33110 Mersin Universitesi Tip Fakultesi HastanesiMersin, Turkey, 33110 Karadeniz Teknik Universitesi Tip Fakultesi, Ic HastaliklariTrabzon, Turkey, 61080 Karadeniz Teknik Universitesi Tip FakultesiTrabzon, Turkey, 61080 Bulent Ecevit Universitesi Tip FakultesiZonguldak, Turkey, 67600|Chernivtsi, Ukraine, 58001 Regional Municipal Institution \"Chernivtsi Regional Clinical Hospital\", Surgery DepartmentChernivtsi, Ukraine, 58001 Municipal Healthcare Institution Kharkiv City Clinical Hospital #2 N.A. Prof. O.O. ShalimovKharkiv, Ukraine, 61037 Private Enterprise Of Private Manufacturing Company \"Acinus\", Medical And Diagnostic CenterKropyvnytskyi, Ukraine, 25006 Kyiv Municipal Clinical Hospital #18, Proctology DepartmentKyiv, Ukraine, 01030 Med Centre 'Ok!Clinic+'Kyiv, Ukraine, 02091 Medical Center \"Ok Clinic+\" Of International Institute Of Clinical TrialsKyiv, Ukraine, 02091 Medical Center \"Universal Clinic Oberig\" Of \"Kapital\" Llc, Gastro CenterKyiv, Ukraine, 03680 Lviv Clinical Hospital On Railway Transport Of Health Care Center Branch Of Pjsc Ukrainian RailwayLviv, Ukraine, 79007 Vinnytsia City Clinical Hospital No.1Vinnytsia, Ukraine, 21000 Private Small-Scale Enterprise Medical Center \"Pulse\"Vinnytsia, Ukraine, 21001 Vinnytsia Regional Clinical Hospital For War VeteransVinnytsia, Ukraine, 21005 Vinnytsia Regional Clinical Hospital N.A. M.I.PyrohovVinnytsia, Ukraine, 21018|Abu Dhabi, United Arab Emirates, 112412 Al|Dothan, Alabama, United States, 36301 Gut P.C., Dba Digestive Health Specialists Of The SoutheastDothan, Alabama, United States, 36305|Beverly Hills, California, United States, 90210 Long Beach Clinical Trial Services, Inc.Long Beach, California, United States, 90806 Entertainment Medical GroupLos Angeles, California, United States, 90036 Gastrointestinal Biosciences Clinical Trials, LlcLos Angeles, California, United States, 90067 Alliance Clinical Research, LlcPoway, California, United States, 92064|Colorado Springs, Colorado, United States, 80903 Peak Gastroenterology AssociatesColorado Springs, Colorado, United States, 80907|Clearwater, Florida, United States, 33756-3839 West Coast Endoscopy CenterClearwater, Florida, United States, 33756 Gastro FloridaClearwater, Florida, United States, 33762 Uf Health Jacksonville - Gastroenterology EmersonJacksonville, Florida, United States, 32207 Uf Health Jacksonville - Faculty ClinicJacksonville, Florida, United States, 32209 University Of Miami Clinical Research BuildingMiami, Florida, United States, 33136 University Of Miami Crohn'S And Colitis CenterMiami, Florida, United States, 33136 University Of Miami Hospital And ClinicsMiami, Florida, United States, 33136 University Of Miami HospitalMiami, Florida, United States, 33136 Millenia Surgery CenterOrlando, Florida, United States, 32811 Hmd Research LlcOrlando, Florida, United States, 32819|Boise, Idaho, United States, 83706 Idaho Gastroenterology AssociatesMeridian, Idaho, United States, 83642|Shawnee Mission, Kansas, United States, 66217|Houma, Louisiana, United States, 70360 Gulf Coast Surgical CenterHouma, Louisiana, United States, 70360 The Hearing Center (Audiology)Houma, Louisiana, United States, 70360|Chevy Chase, Maryland, United States, 20815 Mgg Group Co., Inc., Chevy Chase Clinical ResearchChevy Chase, Maryland, United States, 20815 Capitol ResearchRockville, Maryland, United States, 20850|Boston, Massachusetts, United States, 02115 Mass Eye And Ear, LongwoodBoston, Massachusetts, United States, 02115 Brigham And Women'S HospitalBoston, Massachusetts, United States, 02215 Brigham And Women'S HospitalChestnut Hill, Massachusetts, United States, 02467 Umass Memorial Medical CenterWorcester, Massachusetts, United States, 01655 University Of Massachusetts Medical SchoolWorcester, Massachusetts, United States, 01655|Caro, Michigan, United States, 48723 Clinical Research Institute Of Michigan, LlcChesterfield, Michigan, United States, 48047 Eastside Endoscopy CenterMacomb, Michigan, United States, 48044 Eastside Endoscopy CenterSaint Clair Shores, Michigan, United States, 48081|Ocean Springs, Mississippi, United States, 39564|New York, New York, United States, 10021 Weill Cornell Medical CollegeNew York, New York, United States, 10021 New York Presbyterian Hospital - Weill Cornell Medical College (Colonoscopy)New York, New York, United States, 10065 New York Presbyterian Hospital - Weill Cornell Medical College Investigational PharmacyNew York, New York, United States, 10065 Weill Cornell Medical College - New York Presbyterian Hospital (Endoscopy Suite)New York, New York, United States, 10065 Weill Cornell Medical College - New York Presbyterian HospitalNew York, New York, United States, 10065 Digiovanna Institute For Medical Education And ResearchNorth Massapequa, New York, United States, 11758-1853|Chapel Hill, North Carolina, United States, 27514 Unc Hospitals Endoscopy Center At MeadowmontChapel Hill, North Carolina, United States, 27517 University Of North Carolina At Chapel HillChapel Hill, North Carolina, United States, 27599 Gastroenterology Associates Of The Piedmont, PaWinston-Salem, North Carolina, United States, 27103 Pmg Research Of Winston-Salem, LlcWinston-Salem, North Carolina, United States, 27103|Oklahoma City, Oklahoma, United States, 73112|Kingsport, Tennessee, United States, 37660 Holston Valley Surgery CenterKingsport, Tennessee, United States, 37660 Vanderbilt University Medical CenterNashville, Tennessee, United States, 37212-1375 Vanderbilt University Medical CenterNashville, Tennessee, United States, 37212-1610 Vanderbilt University Medical Center - Gi Endoscopy LabNashville, Tennessee, United States, 37232-5543 Vanderbilt University Medical CenterNashville, Tennessee, United States, 37232-7610 Vanderbilt University Medical Center - Gi Research RegulatoryNashville, Tennessee, United States, 37232|Arlington, Texas, United States, 76012 Envision Imaging (Cxr)Arlington, Texas, United States, 76012 Texas Clinical Research Institiute, LlcArlington, Texas, United States, 76012 First Street HospitalBellaire, Texas, United States, 77401 First Street Surgical CenterBellaire, Texas, United States, 77401 Pearland Surgery CenterHouston, Texas, United States, 77047 Lonestar Endoscopy, LlpSouthlake, Texas, United States, 76092 Texas Digestive Disease ConsultantsSouthlake, Texas, United States, 76092|Fairfax, Virginia, United States, 22031","Alabama|California|Colorado|Florida|Idaho|Kansas|Louisiana|Maryland|Massachusetts|Michigan|Mississippi|New York|North Carolina|Oklahoma|Tennessee|Texas|Virginia","Australia|Austria|Belgium|Bosnia And Herzegovina|Canada|Croatia|Czechia|France|Georgia|Germany|Hungary|Italy|Kuwait|Lebanon|Poland|Saudi Arabia|Serbia|Slovakia|South Africa|Spain|Switzerland|Tunisia|Turkey|Ukraine|United Arab Emirates|United States","New South Wales Concord Repatriation General Hospital|Queensland Mater Misericordiae Ltd|Saint John Of God Health Care Inc.|Victoria Ballarat Base Hospital|Akh Wien Universitaetsklinik Fuer Innere Medizin Iii|University Hospital Brussels|Javna Zdravstvena Ustanova Univerzitetski Klinicki Centar Republike Srpske,|Manitoba Winnipeg Regional Health Authority - Health Sciences Centre, Winnipeg|Ontario HÃ´pital Montfort|Quebec Rocklandmd|Hrvatska Klinicki Bolnicki Centar Sestre Milosrdnice|Klinicki Bolnicki Centar Rijeka, Odjel Za Gastroenterologiju|Lekarna Altea|Hospital|The First University Clinic Of Tsmu|Paian Med Research Gmbh|Bekes Megyei Kozponti Korhaz, Rethy Pal Tagkorhaz|A.O.U. Policlinico G. Martino|Bari Irccs Saverio De Bellis|Bs A.O.Spedali Civili|Cz Univ. \"Magna Graecia\" Di Catanzaro|Mb Asst Monza|Milan Istituto Clinico Humanitas Irccs - Ibd Center|Milano Asst Rhodense - Ospedale Di Circolo Di Rho|Hospital - Dubai|Saint George Hospital University Medical Center|Niepubliczny Zaklad Opieki Zdrowotnej All-Medicus|Silesia H-T. Centrum Medyczne-Endoterapia|King Abdulaziz Medical City|Beograd Klinicko Bolnicki Centar \"Bezanijska Kosa\"|Klinicko Bolnicki Centar Zvezdara, Klinika Za Interne Bolesti,|Srbija Klinicki Centar Srbije, Klinika Za Gastroenterohepatologiju|Fakultna Nemocnica S Poliklinikou F.D. Roosevelta Banska Bystrica|, Gauteng Lenasia Clinical Trial Centre|, Western Cape Dr Wright Private Practice|Cantabria Hospital Universitario Marques De Valdecilla|Hospital Universitario Ramon Y Cajal|UniversitÃ¤tsspital ZÃ¼rich|La Rabta Hospital|Ankara Universitesi Tip Fakultesi, Ibn-I Sina Hastanesi, Ic Hastaliklari Anabilim Dali,|Regional Municipal Institution \"Chernivtsi Regional Clinical Hospital\", Gastroenterology Department,|Cleveland Clinica Abu Dhabi, Department Of Gastroenterology And Hepatology|Dothan Surgery Center|Brighton Surgical Center|Front Range Endoscopy Center|Gastro Florida|Treasure Valley Medical Research|Westglen Gastrointestinal Consultants, P.A.|Cronola, Llc|Chevy Chase Endoscopy Center|Brigham And Women's Hospital|Caro Health Plaza|Digestive Health Center|Weill Cornell Medical College (Clinical Site)|Unc Hospitals|Digestive Disease Specialists, Inc.|Holston Medical Group|Cross Timbers Surgery Center L.P. (Colonoscopy)|Verity Research, Inc.",{"$nulls":3},"Pfizer CT.gov Call Center","2020-04-07","2020-05-25T16:36:06.786","2020-05-26T17:10:42.972","NCT03395184"]
["5ecbf3f6307e3d1b1f8d9c9e","NCT03395184","2020-04-28","Pfizer","PFE","Recruiting","Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PFâ€‘06700841 In Subjects With Moderate To Severe Crohn's Disease","Brepocitinib|Pf-06651600","JAK1 Inhibitor|TYK2 Inhibitor|JAK1 Inhibitor|JAK3 Inhibitor","Yes","['Brepocitinib', 'Pf-06651600']","Yes","['TYK2 Inhibitor', 'JAK3 Inhibitor']","Phase 2",2,250,"Anticipated","2018-02-02","2022-11-30","DAS","Disease Activity Score",{"$nulls":3},"The objectives of this study are to evaluate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-06651600 (200 mg for 8 weeks followed by 50 mg for 4 weeks) dosed once daily and PF-06700841 (60 mg for 12 weeks) dosed once daily during an induction period of 12 weeks, followed by an open label extension period at doses of 50 mg and 30 mg of PF 06651600 and PF 06700841, respectively, for 52 weeks.",null,"A PHASE 2A, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ORAL PF-06651600 AND PF-06700841 AS INDUCTION AND OPEN LABEL EXTENSION TREATMENT IN SUBJECTS WITH MODERATE TO SEVERE CROHN'S DISEASE","B7981007","Crohn's Disease","Crohn Disease","Gastrointestinal Diseases","Gastrointestinal","Experimental","PF-06700841 or placebo|PF-06651600 or placebo",null,"Drug","Placebo PF-06700841|PF-06700841|Placebo PF-06651600|PF-06651600","12 weeks, followed by PF-06700841, 30 mg QD for 52 weeks.|60 mg QD for 12 weeks followed by 30 mg QD for up to 52 weeks|12 weeks, followed by PF-06651600, 50 mg QD for 52 weeks|200 mg QD for 8 weeks, followed by 50 mg QD up to 56 weeks",null,"PF-06700841 or placebo|PF-06651600 or placebo","\n\n 1. Male and/or female subjects 18 years to 75 years of age\n 2. Documented diagnosis of ileal, ileocolonic, or colonic CD with a minimum disease duration of 3 months, as determined by endoscopic and histopathology assessment.\n 3. Endoscopic confirmation of active disease with total SES CD total score of at least 7. For isolated ileal disease, SES CD total score should be at least 4.\n 4. An average daily liquid/soft stool frequency (SF) greater than or equal to 2.5 or daily abdominal pain (AP) greater than or equal to 2.0.\n 5. Must have inadequate response to, loss of response to, or intolerance to at least one conventional therapy for CD:â€¢Steroids; Immunosuppressants (azathioprine [AZA], 6 MP, or methotrexate [MTX]); Anti TNF inhibitors (infliximab, adalimumab,certolizumab); Anti integrin inhibitors (eg, vedolizumab); Anti IL 12/23 inhibitor (ustekinumab).\n    \n    \n 6. Subjects currently receiving the following treatment for CD are eligible providing they have been on stable doses as described below: * Oral corticosteroids (prednisone or equivalent up to 25 mg/day; budesonide up to 9 mg/day). Stable dose for at least 2 weeks prior to baseline. If oral corticosteroids have been recently discontinued, they must have been stopped at least 2 weeks prior to baseline. Decreases in steroid use due to AEs are allowed.\n     * Oral 5 ASA or sulfasalazine are allowed providing that the dose is stable for at least 4 weeks prior to baseline.\n     * Crohn's disease related antibiotics are allowed providing that the dose is stable for at least 4 weeks prior to baseline. If antibiotics are stopped prior to baseline, they must be discontinued at least 4 days prior to baseline.\n    \n    \n\n","\n\n 1.  Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, diverticular disease, ulcerative colitis (UC), or clinical findings suggestive of UC.\n 2.  Presence of active (draining) fistulae or intra abdominal or perineal abscesses.\n 3.  Strictures with obstructive symptoms.\n 4.  Short bowel syndrome.\n 5.  History of bowel perforation requiring surgical intervention within the past 12 months.\n 6.  Previous bowel surgery resulting in an existing stoma. Subjects who have a j pouch are excluded, as a j pouch can result in a stoma.\n 7.  History of bowel surgery within 6 months prior to baseline.\n 8.  Subjects displaying clinical signs of fulminant colitis or toxic megacolon.\n 9.  Subjects with primary sclerosing cholangitis.\n 10. Subjects with evidence of colonic adenomas, dysplasia or neoplasia.\n 11. Abnormal findings on the chest x ray film such as presence of tuberculosis (TB), general infections, heart failure, or malignancy.\n 12. Any history of either untreated or inadequately treated latent or active TB infection, current treatment for active or latent TB infection or evidence of currently active TB by chest x ray, residing with or frequent close contact with individual(s) with active TB.\n 13. Subjects receiving the following therapies within the time period described below or expected to receive any of these therapies during the study period: 1.  >9 mg/day of oral budesonide or >25 mg/day of prednisone or equivalent oral systemic corticosteroid dose within 2 weeks prior to baseline.\n      2.  IV, IM (parenteral), or topical (rectal) treatment of 5 ASA or corticosteroid enemas/suppositories within 2 weeks prior to baseline.\n      3.  Azathioprine, 6 mercaptopurine, or methotrexate within 2 weeks prior to baseline.\n      4.  Anti TNF inhibitors (or biosimilars thereof) as described below: * Infliximab within 8 weeks prior to baseline;\n           * Adalimumab within 8 weeks prior to baseline;\n           * Certolizumab within 8 weeks prior to baseline;\n          \n          \n      5.  Anti integrin inhibitors (eg, vedolizumab) within 8 weeks prior to baseline.\n      6.  Ustekinumab within 8 weeks prior to baseline.\n      7.  Interferon therapy within 8 weeks prior to baseline.\n      8.  Subjects with prior treatment with lymphocyte depleting agents/therapies within 1 year prior to baseline (eg, CamPath[alemtuzumab], alkylating agents [eg, cyclophosphamide or chlorambucil], total lymphoid irradiation, etc).\n      9.  Subjects who have received rituximab or other selective B lymphocyte depleting agents within 1 year prior to baseline.\n      10. Subjects previously receiving leukocyte apheresis, including selective lymphocyte, monocyte, or granulocyte apheresis, or plasma exchange within 6 months prior to baseline.\n      11. Other marketed immunosuppressants or biologics with immunomodulatory properties within 3 months prior to baseline.\n      12. Subjects who have received other JAK inhibitors within 3 months prior to baseline.\n      13. Subjects who have not responded to or have been intolerant of other JAK inhibitors.\n      14. Other investigational procedures(s) or product(s), such as immunosuppressants used in transplantation (eg, mycophenolate mofetil, cyclosporine, rapamycin, or tacrolimus) or live (attenuated) vaccine within 30 days prior to baseline.","TNF","tumor necrosis factor","Protein","Lung, Breast, Ovary","Actual","2018-01-10","Actual","Anticipated","2022-11-30","Anticipated","2020-04-01","2017-12-05","2018-01-03","2020-04-24","Yes",null,"Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years","75 Years","All",null,"No","Yes\nPfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",null,"URL: https://pmiform.com/clinical-trial-info-request?StudyID=B7981007 [https://pmiform.com/clinical-trial-info-request?StudyID=B7981007] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To obtain contact information for a study center near you, click here.",null,"Yes","No",{"$nulls":17},"2017-003359-43|PIZZICATO","EudraCT Number|Alias Study Number","Proportion of subjects achieving clinically meaningful endoscopic improvement (reduction of more than or equal to 3 points from baseline in Simplified Endoscopic Activity Score for Crohn's Disease (SES-CD) at Week 12|Number of subjects with adverse events|Number of subjects with serious adverse events|Number of subjects with electrocardiogram findings of potential clinical importance|Number of subjects with laboratory tests findings of potential clinical importance|Number of subjects withdrawal due to adverse events|Number of subjects with vital signs findings of potential clinical importance","12 weeks|Baseline of extension period (Week 12) to week 68",null,"Number of participants with potentially clinically important serious infections findings|Mean change from baseline in SES-CD score at Week 12.|Proportion of subjects achieving SES-CD 25 and SES-CD 50 at Week 12.|Proportion of subjects achieving endoscopic remission (SES-CD less than or equal to 2) at Week 12.|Proportion of subjects achieving mucosal healing at Week 12.|Number of subjects with adverse events|Number of subjects with serious adverse events|Number of subjects with electrocardiogram findings of potential clinical importance.|Number of subjects withdrawal due to adverse events|Number of subjects with vital signs findings of potential clinical importance.|Number of subjects with laboratory tests findings of potential clinical importance.|Proportion of subjects achieving SES CD 25 and SES CD 50 at Week 64 among subjects who achieved SES CD 25 and SES CD 50 at week 12 respectively.|Proportion of subjects achieving clinically meaningful endoscopic improvement (CMEI response) at week 64 among subjects who achieved CMEI response at Week 12.","64 weeks|Baseline, week 12|Number of subjects achieving SES-CD 25 and SES-CD 50 at Week 12.|Number of subjects achieving endoscopic remission (SES-CD less than or equal to 2) at Week 12.|Number of subjects achieving mucosal healing at Week 12.|Number of participants with reported adverse events|Number of participants with reported serious adverse events|Number of participants with potentially clinically important electrocardiogram findings.|Number of subjects withdrawal due to adverse events.|Number of participants with potentially clinically important vital signs findings.|Number of participants with potentially clinically important laboratory findings.|Number of subjects achieving SES-CD 25 and SES-CD 50 at Week 64 among subjects who achieved SES CD 25 and SES CD 50 at week 12|Number of subject achieving clinically meaningful endoscopic improvement (CMEI response) at week 64 among subjects who achieved CMEI response at week 12.","Baseline, week 12|Week 12|Baseline of induction period to week 12|week 64","ClinicalTrials.gov_Inquiries@pfizer.com","Pfizer CT.gov Call Center","1-800-718-1021","Concord, New South Wales, Australia, 2139|South Brisbane, Queensland, Australia, 4101|Subiaco, Western|[Active, Not Recruiting]Ballarat, Victoria, Australia, 3350|Wien, Austria, 1090|Jette, Belgium, 1090 University Hospitals LeuvenLeuven, Belgium, 3000 Chc MontlÃ©giaLiÃ¨ge, Belgium|Banja Luka, Bosnia And Herzegovina, 78000 Sveucilisna Klinicka Bolnica Mostar,Mostar, Bosnia And Herzegovina, 88000|Winnipeg, Manitoba, Canada, R3A 1R9|Mont-Royal, Quebec, Canada, H3P 2V9 Cmiim (Le Centre Des Maladies Inflammatoires Et Intestinales De Montreal)Mont-Royal, Quebec, Canada, H3P 3E5 Ciusss De L'Est-De-L'Ile-De-Montreal Installation Hopital Maisonneuve-RosemontMontreal, Quebec, Canada, H1T 2M4|Zagreb, Hrvatska, Croatia, 10000|Rijeka, Croatia, 51000 Klinicki Bolnicki Centar Split, Zavod Za GastroenterologijuSplit, Croatia, 21000 Opca Bolnica Zadar, Odjel Za GastroenterologijuZadar, Croatia, 23000 Klinicka Bolnica Dubrava ZagrebZagreb, Croatia, 10000 Klinicki Bolnicki Centar Zagreb, Zavod Za Gastroenterologiju I HepatologijuZagreb, Croatia, 10000|Bilina, Czechia, 41801 Nemocnice Horovice, A.S.Horovice, Czechia, 268 31 Hepato-Gastroenterologie Hk S.R.O.Hradec Kralove, Czechia, 500 12 Medialpharma S.R.O.Hradec Kralove, Czechia, 500 12 Gastroenterologicka Ambulance A EndoskopieMost, Czechia, 43401 Vseobecna Fakultni NemocnicePraha 2, Czechia, 128 08 VÅ¡eobecnÃ¡ FakultnÃ­ Nemocnice V PrazePraha 2, Czechia, 128 08 Lekarna Sv. AnnaPraha 3, Czechia, 130 00 Egk S.R.O. - Sanatorium Sv. AnnyPraha 3, Czechia, 13000 Fakultni Nemocnice V MotolePraha 5, Czechia, 150 06 FakultnÃ­ Nemocnice V MotolePraha 5, Czechia, 150 06 Nemocnice Strakonice, A.S., Interni OddeleniStrakonice, Czechia, 386 01 Nemocnice Strakonice, A.S.Strakonice, Czechia, 386 29|Achrafieh, Beirut, Lebanon|Tbilisi, Georgia, 0141 Institute Of Clinical Cardiology, Ltd.Tbilisi, Georgia, 0159 David Tatishvili Medical CenterTbilisi, Georgia, 0186|Berlin, Germany, 10318 Krankenhaus Waldfriede E.V.,Berlin, Germany, 14163 Universitaetsklinikum BonnBonn, Germany, 53127 Universitaetsklinikum Schleswig-HolsteinKiel, Germany, 24105 UniversitÃ¤tsklinikum Giessen Und Marburg GmbhMarburg, Germany, 35043|Bekescsaba, Hungary, 5600 Semmelweis Egyetem, Ii. Belgyogyaszati KlinikaBudapest, Hungary, 1088 Szent Janos Korhaz Es Eszak-Budai Egyesitett Korhazak[Active, Not Recruiting]Budapest, Hungary, 1125 Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz, Endoszkopos LaboratoriumGyula, Hungary, 5700 Clinfan Szolgaltato Kft.Szekszard, Hungary, 7100 Csolnoky Ferenc Korhaz Belgyogyaszati Centrum I. Belgyogyaszati OsztalyVeszprem, Hungary, 8200|Messina, Italy, 98125 Aou Policlinico Di ModenaModena, Italy, 41124 Azienda Ospedaliera Di PadovaPadova, Italy, 35128 Policlinico Universitario Campus Bio-MedicoRoma, Italy, 00128 Policlinico Gemelli/Complesso Integrato ColumbusRome, Italy, 00168 Korea, Republic Of, Korea Kyungpook National University HospitalDaegu, Korea, Korea, Republic Of, 41944 Korea, Republic Of Kyung Hee University HospitalSeoul, Korea, Republic Of, 02447 Kangbuk Samsung HospitalSeoul, Korea, Republic Of, 03181 Severance Hospital, Yonsei University Health SystemSeoul, Korea, Republic Of, 03722 The Catholic University Of Korea, Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591|Castellana Grotte, Bari, Italy, 70013|Brescia, Bs, Italy, 25123|Catanzaro, Cz, Italy, 88100|Monza, Mb, Italy, 20090|Rozzano, Milan, Italy, 20089|Rho, Milano, Italy, 20017|Dubai, United Arab Emirates, 22241 Emirates Specialty HospitalDubai, United Arab Emirates, Po Box 505240|Achrafieh, Lebanon American University Of Beirut Medical CenterBeirut, Lebanon Ain Wazein Medical VillageEl Chouf, Lebanon Centre Hospitalier Universitaire Notre Dame De SecoursJbeil, Lebanon Hammoud Hospital University Medical CenterSaida, Lebanon|Katowice, Poland, 40-659 Etg KielceKielce, Poland, 25-355 Indywidualna Specjalistyczna Praktyka Lekarska Maciej ZymlaKnurow, Poland, 44-190 Szpital W Knurowie Sp. Z O.O.Knurow, Poland, 44-190 Centrum Badan Klinicznych JciKrakow, Poland, 30-348 Marta Dagmara Banach Marta Banach Specjalistyczny Gabinet NeurologicznyKrakow, Poland, 30-539 Centrum Medyczne EvitaKrakow, Poland, 31-153 Szpital Specjalistyczny Im. Ludwika Rydygiera W Krakowie Sp. Z O.O.Krakow, Poland, 31-826 Centrum Medyczne Szpital Swietej Rodziny Sp Z O.O.Lodz, Poland, 90-302 Pracownia Endoskopii Centrum Medyczne Szpital Swietej Rodziny Sp Z O.O.Lodz, Poland, 90-302 Medical Magnus ClinicLodz, Poland, 90-552 Wojewodzki Szpital Specjalistyczny Im. Bieganskiego W LodziLodz, Poland, 91-347 Gastromed Sp. Z O.O.Lublin, Poland, 20-582 Ai Centrum Medyczne Sp. Z O.O. Sp.K.Poznan, Poland, 61-113 Korczowski Bartosz Gabinet LekarskiRzeszow, Poland, 35-302 Endoskopia Sp. Z O. O.Sopot, Poland, 81-756 Szpital Sredzki Serca Jezusowego Sp. Z O.O.Sroda Wielkopolska, Poland, 63-000 Ez-Med Sp. Z O.O. Sp.K.Swidnica, Poland, 58-100 Pracownia Endoskopii Szpital MswSzczecin, Poland, 70-001 Twoja Przychodnia Szczecinskie Centrum MedyczneSzczecin, Poland, 71-434 Gastromed Kopon, Zmudzinski I Wspolnicy Sp.J.Torun, Poland, 87-100 Centrum Zdrowia MdmWarszawa, Poland, 00-635 Wip Warsaw Ibd Point Profesor KierkusWarszawa, Poland, 00-728 Endoterapia Pfg Sp. Z O.O.Warszawa, Poland, 02-653 Centrum Diagnostyczno-Lecznicze Barska Sp. Z O. O.Wloclawek, Poland, 87-800 Melita Medical Sp. Z O.O.Wroclaw, Poland, 50-449 Centrum Gastrologiczno HepatologiczneWroclaw, Poland, 50-555 Planetmed Sp. Z.O.O.Wroclaw, Poland, 52-210 LexmedicaWroclaw, Poland, 53-114 Russian Federation, Sestroretsk Spb Sbih \"City Hospital #40 Of The Kurortnyi Region\"Saint-Petersburg, Sestroretsk, Russian Federation, 197706 Russian Federation Llc \"Alliance Biomedical-Ural Group\"Izhevsk, Russian Federation, 426061 Clinic Of Fsbei He Ksmu Moh RfKrasnodar, Russian Federation, 350072 Llc \"Olla-Med\"Moscow, Russian Federation, 105554 Sechenov University On The Base Of Institute Of Translational Medicine And BiotechnologyMoscow, Russian Federation, 119435 Limited Liability Company \"Medical Center Sibnovomed\"Novosibirsk, Russian Federation, 630005 Federal State Budgetary Scientific Institution \"Scientific Research Institute Of Physiology AndNovosibirsk, Russian Federation, 630117 Clinic At Fsbei He \"Omsk State Medical University\" Moh RfOmsk, Russian Federation, 644050 Llc \"New Clinic\"Pyatigorsk, Russian Federation, 357500 Limited Liability Company \"Riat\"Saint-Petersburg, Russian Federation, 195220 Saint-Petersburg State Budgetary Healthcare Institution \"City Hospital #26\"Saint-Petersburg, Russian Federation, 196247 Private Institution Educational Organization Of Higher EducationSamara, Russian Federation, 443011 Non-State Healthcare Institution 'Railway Clinical Hospital At Samara Station Of Open Joint StockSamara, Russian Federation, 443029 Limited Liability Company Medical Company \"Hepatolog\"Samara, Russian Federation, 443093 Saint-Petersburg State Budgetary Healthcare Institution \"City Clinical Hospital Of The RighteousSt. Petersburg, Russian Federation, 197706|Tychy, Silesia, Poland, 43-100|Jeddah, Saudi Arabia, 21423 King Abdulaziz Medical CityRiyadh, Saudi Arabia, 11426 King Khalid University HospitalRiyadh, Saudi Arabia, 11472|Zemun, Beograd, Serbia, 11080|Beograd, Serbia, 11000 Vojnomedicinska Akademija, Klinika Za Gastroenterologiju I HepatologijuBeograd, Serbia, 11000 Kbc \"Dr Dragisa Misovic-Dedinje\"Beograd, Serbia, 11040 Klinicko Bolnicki Centar Zemun, Klinika Za Internu Medicinu,Zemun, Beograd, Serbia, 11080|Beograd, Srbija, Serbia, 11000 Klinicki Centar KragujevacKragujevac, Srbija, Serbia, 34000 Klinicki Centar NisNis, Srbija, Serbia, 18000 Opsta Bolnica SuboticaSubotica, Srbija, Serbia, 24000 Opsta Bolnica \"Djordje Joanovic\", Odeljenje Interno, Odsek GastroenterologijaZrenjanin, Srbija, Serbia, 23000|Banska Bystrica, Slovakia, 975 17 Breznianske Centrum Gastroenterologie S.R.O.Brezno, Slovakia, 97701 Km Management Spol. S.R.O.Nitra, Slovakia, 949 01 Accout Center S.R.O. Gastroenterologicka AmbulanciaSahy, Slovakia, 936 01 Endomed, S.R.O.Vranov Nad Toplou, Slovakia, 093 01|Lenasia, Gauteng, South Africa, 1827 Wits Clinical Research Trial SiteParktown, Gauteng, South Africa, 2193 Wits Clinical Reasearch - Wits Bara Clinical Trial SiteSoweto, Gauteng, South Africa, 2013|Claremont, Western Cape, South Africa, 7708|Santander, Cantabria, Spain, 39008|Madrid, Spain, 28034 Hospital Universitario Virgen Del RocioSevilla, Spain, 41013 Hospital Universitari I Politecnic La FeValencia, Spain, 46026|ZÃ¼rich, Switzerland, Ch-8091|Tunis, Tunisia, 1007 Habib Thameur HospitalTunis, Tunisia, 1008|Ankara, Turkey, 06100 Ankara Universitesi Tip Fakultesi, Ibn-I Sina HastanesiAnkara, Turkey, 06100 Hacettepe Universitesi Tip FakultesiAnkara, Turkey, 06230 Bezmialem Vakif Universitesi Tip Fakultesi HastanesiIstanbul, Turkey, 34093 Istanbul Universitesi Cerrahpasa Tip FacultesiIstanbul, Turkey, 34098 Istanbul Universitesi Cerrahpasa Tip FakultesiIstanbul, Turkey, 34098 Erciyes Universitesi Tip FakultesiKayseri, Turkey, 38039 Kocaeli Universitesi Tip FakultesiKocaeli, Turkey, 41380 Mersin Universitesi Tip Fakultesi Hastanesi, Ic HastaliklariMersin, Turkey, 33110 Mersin Universitesi Tip Fakultesi HastanesiMersin, Turkey, 33110 Karadeniz Teknik Universitesi Tip Fakultesi, Ic HastaliklariTrabzon, Turkey, 61080 Karadeniz Teknik Universitesi Tip FakultesiTrabzon, Turkey, 61080 Bulent Ecevit Universitesi Tip FakultesiZonguldak, Turkey, 67600|Chernivtsi, Ukraine, 58001 Regional Municipal Institution \"Chernivtsi Regional Clinical Hospital\", Surgery DepartmentChernivtsi, Ukraine, 58001 Municipal Healthcare Institution Kharkiv City Clinical Hospital #2 N.A. Prof. O.O. ShalimovKharkiv, Ukraine, 61037 Private Enterprise Of Private Manufacturing Company \"Acinus\", Medical And Diagnostic CenterKropyvnytskyi, Ukraine, 25006 Kyiv Municipal Clinical Hospital #18, Proctology DepartmentKyiv, Ukraine, 01030 Med Centre 'Ok!Clinic+'Kyiv, Ukraine, 02091 Medical Center \"Ok Clinic+\" Of International Institute Of Clinical TrialsKyiv, Ukraine, 02091 Medical Center \"Universal Clinic Oberig\" Of \"Kapital\" Llc, Gastro CenterKyiv, Ukraine, 03680 Lviv Clinical Hospital On Railway Transport Of Health Care Center Branch Of Pjsc Ukrainian RailwayLviv, Ukraine, 79007 Vinnytsia City Clinical Hospital No.1Vinnytsia, Ukraine, 21000 Private Small-Scale Enterprise Medical Center \"Pulse\"Vinnytsia, Ukraine, 21001 Vinnytsia Regional Clinical Hospital For War VeteransVinnytsia, Ukraine, 21005 Vinnytsia Regional Clinical Hospital N.A. M.I.PyrohovVinnytsia, Ukraine, 21018|Abu Dhabi, United Arab Emirates, 112412 Al|Dothan, Alabama, United States, 36301 Gut P.C., Dba Digestive Health Specialists Of The SoutheastDothan, Alabama, United States, 36305|Beverly Hills, California, United States, 90210 Long Beach Clinical Trial Services, Inc.Long Beach, California, United States, 90806 Entertainment Medical GroupLos Angeles, California, United States, 90036 Gastrointestinal Biosciences Clinical Trials, LlcLos Angeles, California, United States, 90067 Alliance Clinical Research, LlcPoway, California, United States, 92064|Colorado Springs, Colorado, United States, 80903 Peak Gastroenterology AssociatesColorado Springs, Colorado, United States, 80907|Clearwater, Florida, United States, 33756-3839 West Coast Endoscopy CenterClearwater, Florida, United States, 33756 Gastro FloridaClearwater, Florida, United States, 33762 Uf Health Jacksonville - Gastroenterology EmersonJacksonville, Florida, United States, 32207 Uf Health Jacksonville - Faculty ClinicJacksonville, Florida, United States, 32209 University Of Miami Clinical Research BuildingMiami, Florida, United States, 33136 University Of Miami Crohn'S And Colitis CenterMiami, Florida, United States, 33136 University Of Miami Hospital And ClinicsMiami, Florida, United States, 33136 University Of Miami HospitalMiami, Florida, United States, 33136 Millenia Surgery CenterOrlando, Florida, United States, 32811 Hmd Research LlcOrlando, Florida, United States, 32819|Boise, Idaho, United States, 83706 Idaho Gastroenterology AssociatesMeridian, Idaho, United States, 83642|Shawnee Mission, Kansas, United States, 66217|Houma, Louisiana, United States, 70360 Gulf Coast Surgical CenterHouma, Louisiana, United States, 70360 The Hearing Center (Audiology)Houma, Louisiana, United States, 70360|Chevy Chase, Maryland, United States, 20815 Mgg Group Co., Inc., Chevy Chase Clinical ResearchChevy Chase, Maryland, United States, 20815 Capitol ResearchRockville, Maryland, United States, 20850|Boston, Massachusetts, United States, 02115 Mass Eye And Ear, LongwoodBoston, Massachusetts, United States, 02115 Brigham And Women'S HospitalBoston, Massachusetts, United States, 02215 Brigham And Women'S HospitalChestnut Hill, Massachusetts, United States, 02467 Umass Memorial Medical CenterWorcester, Massachusetts, United States, 01655 University Of Massachusetts Medical SchoolWorcester, Massachusetts, United States, 01655|Caro, Michigan, United States, 48723 Clinical Research Institute Of Michigan, LlcChesterfield, Michigan, United States, 48047 Eastside Endoscopy CenterMacomb, Michigan, United States, 48044 Eastside Endoscopy CenterSaint Clair Shores, Michigan, United States, 48081|Ocean Springs, Mississippi, United States, 39564|New York, New York, United States, 10021 Weill Cornell Medical CollegeNew York, New York, United States, 10021 New York Presbyterian Hospital - Weill Cornell Medical College (Colonoscopy)New York, New York, United States, 10065 New York Presbyterian Hospital - Weill Cornell Medical College Investigational PharmacyNew York, New York, United States, 10065 Weill Cornell Medical College - New York Presbyterian Hospital (Endoscopy Suite)New York, New York, United States, 10065 Weill Cornell Medical College - New York Presbyterian HospitalNew York, New York, United States, 10065 Digiovanna Institute For Medical Education And ResearchNorth Massapequa, New York, United States, 11758-1853|Chapel Hill, North Carolina, United States, 27514 Unc Hospitals Endoscopy Center At MeadowmontChapel Hill, North Carolina, United States, 27517 University Of North Carolina At Chapel HillChapel Hill, North Carolina, United States, 27599 Gastroenterology Associates Of The Piedmont, PaWinston-Salem, North Carolina, United States, 27103 Pmg Research Of Winston-Salem, LlcWinston-Salem, North Carolina, United States, 27103|Oklahoma City, Oklahoma, United States, 73112|Kingsport, Tennessee, United States, 37660 Holston Valley Surgery CenterKingsport, Tennessee, United States, 37660 Vanderbilt University Medical CenterNashville, Tennessee, United States, 37212-1375 Vanderbilt University Medical CenterNashville, Tennessee, United States, 37212-1610 Vanderbilt University Medical Center - Gi Endoscopy LabNashville, Tennessee, United States, 37232-5543 Vanderbilt University Medical CenterNashville, Tennessee, United States, 37232-7610 Vanderbilt University Medical Center - Gi Research RegulatoryNashville, Tennessee, United States, 37232|Arlington, Texas, United States, 76012 Envision Imaging (Cxr)Arlington, Texas, United States, 76012 Texas Clinical Research Institiute, LlcArlington, Texas, United States, 76012 First Street HospitalBellaire, Texas, United States, 77401 First Street Surgical CenterBellaire, Texas, United States, 77401 Pearland Surgery CenterHouston, Texas, United States, 77047 Lonestar Endoscopy, LlpSouthlake, Texas, United States, 76092 Texas Digestive Disease ConsultantsSouthlake, Texas, United States, 76092|Fairfax, Virginia, United States, 22031","Alabama|California|Colorado|Florida|Idaho|Kansas|Louisiana|Maryland|Massachusetts|Michigan|Mississippi|New York|North Carolina|Oklahoma|Tennessee|Texas|Virginia","Australia|Austria|Belgium|Bosnia And Herzegovina|Canada|Croatia|Czechia|France|Georgia|Germany|Hungary|Italy|Kuwait|Lebanon|Poland|Saudi Arabia|Serbia|Slovakia|South Africa|Spain|Switzerland|Tunisia|Turkey|Ukraine|United Arab Emirates|United States","New South Wales Concord Repatriation General Hospital|Queensland Mater Misericordiae Ltd|Saint John Of God Health Care Inc.|Victoria Ballarat Base Hospital|Akh Wien Universitaetsklinik Fuer Innere Medizin Iii|University Hospital Brussels|Javna Zdravstvena Ustanova Univerzitetski Klinicki Centar Republike Srpske,|Manitoba Winnipeg Regional Health Authority - Health Sciences Centre, Winnipeg|Quebec Rocklandmd|Hrvatska Klinicki Bolnicki Centar Sestre Milosrdnice|Klinicki Bolnicki Centar Rijeka, Odjel Za Gastroenterologiju|Lekarna Altea|Hospital|The First University Clinic Of Tsmu|Paian Med Research Gmbh|Bekes Megyei Kozponti Korhaz, Rethy Pal Tagkorhaz|A.O.U. Policlinico G. Martino|Bari Irccs Saverio De Bellis|Bs A.O.Spedali Civili|Cz Univ. \"Magna Graecia\" Di Catanzaro|Mb Asst Monza|Milan Istituto Clinico Humanitas Irccs - Ibd Center|Milano Asst Rhodense - Ospedale Di Circolo Di Rho|Hospital - Dubai|Saint George Hospital University Medical Center|Niepubliczny Zaklad Opieki Zdrowotnej All-Medicus|Silesia H-T. Centrum Medyczne-Endoterapia|King Abdulaziz Medical City|Beograd Klinicko Bolnicki Centar \"Bezanijska Kosa\"|Klinicko Bolnicki Centar Zvezdara, Klinika Za Interne Bolesti,|Srbija Klinicki Centar Srbije, Klinika Za Gastroenterohepatologiju|Fakultna Nemocnica S Poliklinikou F.D. Roosevelta Banska Bystrica|, Gauteng Lenasia Clinical Trial Centre|, Western Cape Dr Wright Private Practice|Cantabria Hospital Universitario Marques De Valdecilla|Hospital Universitario Ramon Y Cajal|UniversitÃ¤tsspital ZÃ¼rich|La Rabta Hospital|Ankara Universitesi Tip Fakultesi, Ibn-I Sina Hastanesi, Ic Hastaliklari Anabilim Dali,|Regional Municipal Institution \"Chernivtsi Regional Clinical Hospital\", Gastroenterology Department,|Cleveland Clinica Abu Dhabi, Department Of Gastroenterology And Hepatology|Dothan Surgery Center|Brighton Surgical Center|Front Range Endoscopy Center|Gastro Florida|Treasure Valley Medical Research|Westglen Gastrointestinal Consultants, P.A.|Cronola, Llc|Chevy Chase Endoscopy Center|Brigham And Women's Hospital|Caro Health Plaza|Digestive Health Center|Weill Cornell Medical College (Clinical Site)|Unc Hospitals|Digestive Disease Specialists, Inc.|Holston Medical Group|Cross Timbers Surgery Center L.P. (Colonoscopy)|Verity Research, Inc.",{"$nulls":3},"Pfizer CT.gov Call Center","2020-04-24","2020-05-25T16:36:06.206","2020-05-26T17:10:42.972","NCT03395184"]
["5ecbf3f611702c1b1b916a1f","NCT03395184","2020-04-29","Pfizer","PFE","Recruiting","Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PFâ€‘06700841 In Subjects With Moderate To Severe Crohn's Disease","Brepocitinib|Pf-06651600","JAK1 Inhibitor|TYK2 Inhibitor|JAK1 Inhibitor|JAK3 Inhibitor","Yes","['Brepocitinib', 'Pf-06651600']","Yes","['TYK2 Inhibitor', 'JAK3 Inhibitor']","Phase 2",2,250,"Anticipated","2018-02-02","2022-11-30","DAS","Disease Activity Score",{"$nulls":3},"The objectives of this study are to evaluate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-06651600 (200 mg for 8 weeks followed by 50 mg for 4 weeks) dosed once daily and PF-06700841 (60 mg for 12 weeks) dosed once daily during an induction period of 12 weeks, followed by an open label extension period at doses of 50 mg and 30 mg of PF 06651600 and PF 06700841, respectively, for 52 weeks.",null,"A PHASE 2A, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ORAL PF-06651600 AND PF-06700841 AS INDUCTION AND OPEN LABEL EXTENSION TREATMENT IN SUBJECTS WITH MODERATE TO SEVERE CROHN'S DISEASE","B7981007","Crohn's Disease","Crohn Disease","Gastrointestinal Diseases","Gastrointestinal","Experimental","PF-06700841 or placebo|PF-06651600 or placebo",null,"Drug","Placebo PF-06700841|PF-06700841|Placebo PF-06651600|PF-06651600","12 weeks, followed by PF-06700841, 30 mg QD for 52 weeks.|60 mg QD for 12 weeks followed by 30 mg QD for up to 52 weeks|12 weeks, followed by PF-06651600, 50 mg QD for 52 weeks|200 mg QD for 8 weeks, followed by 50 mg QD up to 56 weeks",null,"PF-06700841 or placebo|PF-06651600 or placebo","\n\n 1. Male and/or female subjects 18 years to 75 years of age\n 2. Documented diagnosis of ileal, ileocolonic, or colonic CD with a minimum disease duration of 3 months, as determined by endoscopic and histopathology assessment.\n 3. Endoscopic confirmation of active disease with total SES CD total score of at least 7. For isolated ileal disease, SES CD total score should be at least 4.\n 4. An average daily liquid/soft stool frequency (SF) greater than or equal to 2.5 or daily abdominal pain (AP) greater than or equal to 2.0.\n 5. Must have inadequate response to, loss of response to, or intolerance to at least one conventional therapy for CD:â€¢Steroids; Immunosuppressants (azathioprine [AZA], 6 MP, or methotrexate [MTX]); Anti TNF inhibitors (infliximab, adalimumab,certolizumab); Anti integrin inhibitors (eg, vedolizumab); Anti IL 12/23 inhibitor (ustekinumab).\n    \n    \n 6. Subjects currently receiving the following treatment for CD are eligible providing they have been on stable doses as described below: * Oral corticosteroids (prednisone or equivalent up to 25 mg/day; budesonide up to 9 mg/day). Stable dose for at least 2 weeks prior to baseline. If oral corticosteroids have been recently discontinued, they must have been stopped at least 2 weeks prior to baseline. Decreases in steroid use due to AEs are allowed.\n     * Oral 5 ASA or sulfasalazine are allowed providing that the dose is stable for at least 4 weeks prior to baseline.\n     * Crohn's disease related antibiotics are allowed providing that the dose is stable for at least 4 weeks prior to baseline. If antibiotics are stopped prior to baseline, they must be discontinued at least 4 days prior to baseline.\n    \n    \n\n","\n\n 1.  Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, diverticular disease, ulcerative colitis (UC), or clinical findings suggestive of UC.\n 2.  Presence of active (draining) fistulae or intra abdominal or perineal abscesses.\n 3.  Strictures with obstructive symptoms.\n 4.  Short bowel syndrome.\n 5.  History of bowel perforation requiring surgical intervention within the past 12 months.\n 6.  Previous bowel surgery resulting in an existing stoma. Subjects who have a j pouch are excluded, as a j pouch can result in a stoma.\n 7.  History of bowel surgery within 6 months prior to baseline.\n 8.  Subjects displaying clinical signs of fulminant colitis or toxic megacolon.\n 9.  Subjects with primary sclerosing cholangitis.\n 10. Subjects with evidence of colonic adenomas, dysplasia or neoplasia.\n 11. Abnormal findings on the chest x ray film such as presence of tuberculosis (TB), general infections, heart failure, or malignancy.\n 12. Any history of either untreated or inadequately treated latent or active TB infection, current treatment for active or latent TB infection or evidence of currently active TB by chest x ray, residing with or frequent close contact with individual(s) with active TB.\n 13. Subjects receiving the following therapies within the time period described below or expected to receive any of these therapies during the study period: 1.  >9 mg/day of oral budesonide or >25 mg/day of prednisone or equivalent oral systemic corticosteroid dose within 2 weeks prior to baseline.\n      2.  IV, IM (parenteral), or topical (rectal) treatment of 5 ASA or corticosteroid enemas/suppositories within 2 weeks prior to baseline.\n      3.  Azathioprine, 6 mercaptopurine, or methotrexate within 2 weeks prior to baseline.\n      4.  Anti TNF inhibitors (or biosimilars thereof) as described below: * Infliximab within 8 weeks prior to baseline;\n           * Adalimumab within 8 weeks prior to baseline;\n           * Certolizumab within 8 weeks prior to baseline;\n          \n          \n      5.  Anti integrin inhibitors (eg, vedolizumab) within 8 weeks prior to baseline.\n      6.  Ustekinumab within 8 weeks prior to baseline.\n      7.  Interferon therapy within 8 weeks prior to baseline.\n      8.  Subjects with prior treatment with lymphocyte depleting agents/therapies within 1 year prior to baseline (eg, CamPath[alemtuzumab], alkylating agents [eg, cyclophosphamide or chlorambucil], total lymphoid irradiation, etc).\n      9.  Subjects who have received rituximab or other selective B lymphocyte depleting agents within 1 year prior to baseline.\n      10. Subjects previously receiving leukocyte apheresis, including selective lymphocyte, monocyte, or granulocyte apheresis, or plasma exchange within 6 months prior to baseline.\n      11. Other marketed immunosuppressants or biologics with immunomodulatory properties within 3 months prior to baseline.\n      12. Subjects who have received other JAK inhibitors within 3 months prior to baseline.\n      13. Subjects who have not responded to or have been intolerant of other JAK inhibitors.\n      14. Other investigational procedures(s) or product(s), such as immunosuppressants used in transplantation (eg, mycophenolate mofetil, cyclosporine, rapamycin, or tacrolimus) or live (attenuated) vaccine within 30 days prior to baseline.","TNF","tumor necrosis factor","Protein","Lung, Breast, Ovary","Actual","2018-01-10","Actual","Anticipated","2022-11-30","Anticipated","2020-04-01","2017-12-05","2018-01-03","2020-04-28","Yes",null,"Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years","75 Years","All",null,"No","Yes\nPfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",null,"URL: https://pmiform.com/clinical-trial-info-request?StudyID=B7981007 [https://pmiform.com/clinical-trial-info-request?StudyID=B7981007] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To obtain contact information for a study center near you, click here.",null,"Yes","No",{"$nulls":17},"2017-003359-43|PIZZICATO","EudraCT Number|Alias Study Number","Proportion of subjects achieving clinically meaningful endoscopic improvement (reduction of more than or equal to 3 points from baseline in Simplified Endoscopic Activity Score for Crohn's Disease (SES-CD) at Week 12|Number of subjects with adverse events|Number of subjects with serious adverse events|Number of subjects with electrocardiogram findings of potential clinical importance|Number of subjects with laboratory tests findings of potential clinical importance|Number of subjects withdrawal due to adverse events|Number of subjects with vital signs findings of potential clinical importance","12 weeks|Baseline of extension period (Week 12) to week 68",null,"Number of participants with potentially clinically important serious infections findings|Mean change from baseline in SES-CD score at Week 12.|Proportion of subjects achieving SES-CD 25 and SES-CD 50 at Week 12.|Proportion of subjects achieving endoscopic remission (SES-CD less than or equal to 2) at Week 12.|Proportion of subjects achieving mucosal healing at Week 12.|Number of subjects with adverse events|Number of subjects with serious adverse events|Number of subjects with electrocardiogram findings of potential clinical importance.|Number of subjects withdrawal due to adverse events|Number of subjects with vital signs findings of potential clinical importance.|Number of subjects with laboratory tests findings of potential clinical importance.|Proportion of subjects achieving SES CD 25 and SES CD 50 at Week 64 among subjects who achieved SES CD 25 and SES CD 50 at week 12 respectively.|Proportion of subjects achieving clinically meaningful endoscopic improvement (CMEI response) at week 64 among subjects who achieved CMEI response at Week 12.","64 weeks|Baseline, week 12|Number of subjects achieving SES-CD 25 and SES-CD 50 at Week 12.|Number of subjects achieving endoscopic remission (SES-CD less than or equal to 2) at Week 12.|Number of subjects achieving mucosal healing at Week 12.|Number of participants with reported adverse events|Number of participants with reported serious adverse events|Number of participants with potentially clinically important electrocardiogram findings.|Number of subjects withdrawal due to adverse events.|Number of participants with potentially clinically important vital signs findings.|Number of participants with potentially clinically important laboratory findings.|Number of subjects achieving SES-CD 25 and SES-CD 50 at Week 64 among subjects who achieved SES CD 25 and SES CD 50 at week 12|Number of subject achieving clinically meaningful endoscopic improvement (CMEI response) at week 64 among subjects who achieved CMEI response at week 12.","Baseline, week 12|Week 12|Baseline of induction period to week 12|week 64","ClinicalTrials.gov_Inquiries@pfizer.com","Pfizer CT.gov Call Center","1-800-718-1021","Concord, New South Wales, Australia, 2139|South Brisbane, Queensland, Australia, 4101|Subiaco, Western|[Active, Not Recruiting]Ballarat, Victoria, Australia, 3350|Wien, Austria, 1090|Jette, Belgium, 1090 University Hospitals LeuvenLeuven, Belgium, 3000 Chc MontlÃ©giaLiÃ¨ge, Belgium|Banja Luka, Bosnia And Herzegovina, 78000 Sveucilisna Klinicka Bolnica Mostar,Mostar, Bosnia And Herzegovina, 88000|Winnipeg, Manitoba, Canada, R3A 1R9|Mont-Royal, Quebec, Canada, H3P 2V9 Cmiim (Le Centre Des Maladies Inflammatoires Et Intestinales De Montreal)Mont-Royal, Quebec, Canada, H3P 3E5 Ciusss De L'Est-De-L'Ile-De-Montreal Installation Hopital Maisonneuve-RosemontMontreal, Quebec, Canada, H1T 2M4|Zagreb, Hrvatska, Croatia, 10000|Rijeka, Croatia, 51000 Klinicki Bolnicki Centar Split, Zavod Za GastroenterologijuSplit, Croatia, 21000 Opca Bolnica Zadar, Odjel Za GastroenterologijuZadar, Croatia, 23000 Klinicka Bolnica Dubrava ZagrebZagreb, Croatia, 10000 Klinicki Bolnicki Centar Zagreb, Zavod Za Gastroenterologiju I HepatologijuZagreb, Croatia, 10000|Bilina, Czechia, 41801 Nemocnice Horovice, A.S.Horovice, Czechia, 268 31 Hepato-Gastroenterologie Hk S.R.O.Hradec Kralove, Czechia, 500 12 Medialpharma S.R.O.Hradec Kralove, Czechia, 500 12 Gastroenterologicka Ambulance A EndoskopieMost, Czechia, 43401 Vseobecna Fakultni NemocnicePraha 2, Czechia, 128 08 VÅ¡eobecnÃ¡ FakultnÃ­ Nemocnice V PrazePraha 2, Czechia, 128 08 Lekarna Sv. AnnaPraha 3, Czechia, 130 00 Egk S.R.O. - Sanatorium Sv. AnnyPraha 3, Czechia, 13000 Fakultni Nemocnice V MotolePraha 5, Czechia, 150 06 FakultnÃ­ Nemocnice V MotolePraha 5, Czechia, 150 06 Nemocnice Strakonice, A.S., Interni OddeleniStrakonice, Czechia, 386 01 Nemocnice Strakonice, A.S.Strakonice, Czechia, 386 29|Achrafieh, Beirut, Lebanon|Tbilisi, Georgia, 0141 Institute Of Clinical Cardiology, Ltd.Tbilisi, Georgia, 0159 David Tatishvili Medical CenterTbilisi, Georgia, 0186|Berlin, Germany, 10318 Krankenhaus Waldfriede E.V.,Berlin, Germany, 14163 Universitaetsklinikum BonnBonn, Germany, 53127 Universitaetsklinikum Schleswig-HolsteinKiel, Germany, 24105 UniversitÃ¤tsklinikum Giessen Und Marburg GmbhMarburg, Germany, 35043|Bekescsaba, Hungary, 5600 Semmelweis Egyetem, Ii. Belgyogyaszati KlinikaBudapest, Hungary, 1088 Szent Janos Korhaz Es Eszak-Budai Egyesitett KorhazakBudapest, Hungary, 1125 Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz, Endoszkopos LaboratoriumGyula, Hungary, 5700 Clinfan Szolgaltato Kft.Szekszard, Hungary, 7100 Csolnoky Ferenc Korhaz Belgyogyaszati Centrum I. Belgyogyaszati OsztalyVeszprem, Hungary, 8200|Messina, Italy, 98125 Aou Policlinico Di ModenaModena, Italy, 41124 Azienda Ospedaliera Di PadovaPadova, Italy, 35128 Policlinico Universitario Campus Bio-MedicoRoma, Italy, 00128 Policlinico Gemelli/Complesso Integrato ColumbusRome, Italy, 00168 Korea, Republic Of, Korea Kyungpook National University HospitalDaegu, Korea, Korea, Republic Of, 41944 Korea, Republic Of Kyung Hee University HospitalSeoul, Korea, Republic Of, 02447 Kangbuk Samsung HospitalSeoul, Korea, Republic Of, 03181 Severance Hospital, Yonsei University Health SystemSeoul, Korea, Republic Of, 03722 The Catholic University Of Korea, Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591|Castellana Grotte, Bari, Italy, 70013|Brescia, Bs, Italy, 25123|Catanzaro, Cz, Italy, 88100|Monza, Mb, Italy, 20090|Rozzano, Milan, Italy, 20089|Rho, Milano, Italy, 20017|Dubai, United Arab Emirates, 22241 Emirates Specialty HospitalDubai, United Arab Emirates, Po Box 505240|Achrafieh, Lebanon American University Of Beirut Medical CenterBeirut, Lebanon Ain Wazein Medical VillageEl Chouf, Lebanon Centre Hospitalier Universitaire Notre Dame De SecoursJbeil, Lebanon Hammoud Hospital University Medical CenterSaida, Lebanon|Katowice, Poland, 40-659 Etg KielceKielce, Poland, 25-355 Indywidualna Specjalistyczna Praktyka Lekarska Maciej ZymlaKnurow, Poland, 44-190 Szpital W Knurowie Sp. Z O.O.Knurow, Poland, 44-190 Centrum Badan Klinicznych JciKrakow, Poland, 30-348 Marta Dagmara Banach Marta Banach Specjalistyczny Gabinet NeurologicznyKrakow, Poland, 30-539 Centrum Medyczne EvitaKrakow, Poland, 31-153 Szpital Specjalistyczny Im. Ludwika Rydygiera W Krakowie Sp. Z O.O.Krakow, Poland, 31-826 Centrum Medyczne Szpital Swietej Rodziny Sp Z O.O.Lodz, Poland, 90-302 Pracownia Endoskopii Centrum Medyczne Szpital Swietej Rodziny Sp Z O.O.Lodz, Poland, 90-302 Medical Magnus ClinicLodz, Poland, 90-552 Wojewodzki Szpital Specjalistyczny Im. Bieganskiego W LodziLodz, Poland, 91-347 Gastromed Sp. Z O.O.Lublin, Poland, 20-582 Ai Centrum Medyczne Sp. Z O.O. Sp.K.Poznan, Poland, 61-113 Korczowski Bartosz Gabinet LekarskiRzeszow, Poland, 35-302 Endoskopia Sp. Z O. O.Sopot, Poland, 81-756 Szpital Sredzki Serca Jezusowego Sp. Z O.O.Sroda Wielkopolska, Poland, 63-000 Ez-Med Sp. Z O.O. Sp.K.Swidnica, Poland, 58-100 Pracownia Endoskopii Szpital MswSzczecin, Poland, 70-001 Twoja Przychodnia Szczecinskie Centrum MedyczneSzczecin, Poland, 71-434 Gastromed Kopon, Zmudzinski I Wspolnicy Sp.J.Torun, Poland, 87-100 Centrum Zdrowia MdmWarszawa, Poland, 00-635 Wip Warsaw Ibd Point Profesor KierkusWarszawa, Poland, 00-728 Endoterapia Pfg Sp. Z O.O.Warszawa, Poland, 02-653 Centrum Diagnostyczno-Lecznicze Barska Sp. Z O. O.Wloclawek, Poland, 87-800 Melita Medical Sp. Z O.O.Wroclaw, Poland, 50-449 Centrum Gastrologiczno HepatologiczneWroclaw, Poland, 50-555 Planetmed Sp. Z.O.O.Wroclaw, Poland, 52-210 LexmedicaWroclaw, Poland, 53-114 Russian Federation, Sestroretsk Spb Sbih \"City Hospital #40 Of The Kurortnyi Region\"Saint-Petersburg, Sestroretsk, Russian Federation, 197706 Russian Federation Llc \"Alliance Biomedical-Ural Group\"Izhevsk, Russian Federation, 426061 Clinic Of Fsbei He Ksmu Moh RfKrasnodar, Russian Federation, 350072 Llc \"Olla-Med\"Moscow, Russian Federation, 105554 Sechenov University On The Base Of Institute Of Translational Medicine And BiotechnologyMoscow, Russian Federation, 119435 Limited Liability Company \"Medical Center Sibnovomed\"Novosibirsk, Russian Federation, 630005 Federal State Budgetary Scientific Institution \"Scientific Research Institute Of Physiology AndNovosibirsk, Russian Federation, 630117 Clinic At Fsbei He \"Omsk State Medical University\" Moh RfOmsk, Russian Federation, 644050 Llc \"New Clinic\"Pyatigorsk, Russian Federation, 357500 Limited Liability Company \"Riat\"Saint-Petersburg, Russian Federation, 195220 Saint-Petersburg State Budgetary Healthcare Institution \"City Hospital #26\"Saint-Petersburg, Russian Federation, 196247 Private Institution Educational Organization Of Higher EducationSamara, Russian Federation, 443011 Non-State Healthcare Institution 'Railway Clinical Hospital At Samara Station Of Open Joint StockSamara, Russian Federation, 443029 Limited Liability Company Medical Company \"Hepatolog\"Samara, Russian Federation, 443093 Saint-Petersburg State Budgetary Healthcare Institution \"City Clinical Hospital Of The RighteousSt. Petersburg, Russian Federation, 197706|Tychy, Silesia, Poland, 43-100|Jeddah, Saudi Arabia, 21423 King Abdulaziz Medical CityRiyadh, Saudi Arabia, 11426 King Khalid University HospitalRiyadh, Saudi Arabia, 11472|Zemun, Beograd, Serbia, 11080|Beograd, Serbia, 11000 Vojnomedicinska Akademija, Klinika Za Gastroenterologiju I HepatologijuBeograd, Serbia, 11000 Kbc \"Dr Dragisa Misovic-Dedinje\"Beograd, Serbia, 11040 Klinicko Bolnicki Centar Zemun, Klinika Za Internu Medicinu,Zemun, Beograd, Serbia, 11080|Beograd, Srbija, Serbia, 11000 Klinicki Centar KragujevacKragujevac, Srbija, Serbia, 34000 Klinicki Centar NisNis, Srbija, Serbia, 18000 Opsta Bolnica SuboticaSubotica, Srbija, Serbia, 24000 Opsta Bolnica \"Djordje Joanovic\", Odeljenje Interno, Odsek GastroenterologijaZrenjanin, Srbija, Serbia, 23000|Banska Bystrica, Slovakia, 975 17 Breznianske Centrum Gastroenterologie S.R.O.Brezno, Slovakia, 97701 Km Management Spol. S.R.O.Nitra, Slovakia, 949 01 Accout Center S.R.O. Gastroenterologicka AmbulanciaSahy, Slovakia, 936 01 Endomed, S.R.O.Vranov Nad Toplou, Slovakia, 093 01|Lenasia, Gauteng, South Africa, 1827 Wits Clinical Research Trial SiteParktown, Gauteng, South Africa, 2193 Wits Clinical Reasearch - Wits Bara Clinical Trial SiteSoweto, Gauteng, South Africa, 2013|Claremont, Western Cape, South Africa, 7708|Santander, Cantabria, Spain, 39008|Madrid, Spain, 28034 Hospital Universitario Virgen Del RocioSevilla, Spain, 41013 Hospital Universitari I Politecnic La FeValencia, Spain, 46026|ZÃ¼rich, Switzerland, Ch-8091|Tunis, Tunisia, 1007 Habib Thameur HospitalTunis, Tunisia, 1008|Ankara, Turkey, 06100 Ankara Universitesi Tip Fakultesi, Ibn-I Sina HastanesiAnkara, Turkey, 06100 Hacettepe Universitesi Tip FakultesiAnkara, Turkey, 06230 Bezmialem Vakif Universitesi Tip Fakultesi HastanesiIstanbul, Turkey, 34093 Istanbul Universitesi Cerrahpasa Tip FacultesiIstanbul, Turkey, 34098 Istanbul Universitesi Cerrahpasa Tip FakultesiIstanbul, Turkey, 34098 Erciyes Universitesi Tip FakultesiKayseri, Turkey, 38039 Kocaeli Universitesi Tip FakultesiKocaeli, Turkey, 41380 Mersin Universitesi Tip Fakultesi Hastanesi, Ic HastaliklariMersin, Turkey, 33110 Mersin Universitesi Tip Fakultesi HastanesiMersin, Turkey, 33110 Karadeniz Teknik Universitesi Tip Fakultesi, Ic HastaliklariTrabzon, Turkey, 61080 Karadeniz Teknik Universitesi Tip FakultesiTrabzon, Turkey, 61080 Bulent Ecevit Universitesi Tip FakultesiZonguldak, Turkey, 67600|Chernivtsi, Ukraine, 58001 Regional Municipal Institution \"Chernivtsi Regional Clinical Hospital\", Surgery DepartmentChernivtsi, Ukraine, 58001 Municipal Healthcare Institution Kharkiv City Clinical Hospital #2 N.A. Prof. O.O. ShalimovKharkiv, Ukraine, 61037 Private Enterprise Of Private Manufacturing Company \"Acinus\", Medical And Diagnostic CenterKropyvnytskyi, Ukraine, 25006 Kyiv Municipal Clinical Hospital #18, Proctology DepartmentKyiv, Ukraine, 01030 Med Centre 'Ok!Clinic+'Kyiv, Ukraine, 02091 Medical Center \"Ok Clinic+\" Of International Institute Of Clinical TrialsKyiv, Ukraine, 02091 Medical Center \"Universal Clinic Oberig\" Of \"Kapital\" Llc, Gastro CenterKyiv, Ukraine, 03680 Lviv Clinical Hospital On Railway Transport Of Health Care Center Branch Of Pjsc Ukrainian RailwayLviv, Ukraine, 79007 Vinnytsia City Clinical Hospital No.1Vinnytsia, Ukraine, 21000 Private Small-Scale Enterprise Medical Center \"Pulse\"Vinnytsia, Ukraine, 21001 Vinnytsia Regional Clinical Hospital For War VeteransVinnytsia, Ukraine, 21005 Vinnytsia Regional Clinical Hospital N.A. M.I.PyrohovVinnytsia, Ukraine, 21018|Abu Dhabi, United Arab Emirates, 112412 Al|Dothan, Alabama, United States, 36301 Gut P.C., Dba Digestive Health Specialists Of The SoutheastDothan, Alabama, United States, 36305|Beverly Hills, California, United States, 90210 Long Beach Clinical Trial Services, Inc.Long Beach, California, United States, 90806 Entertainment Medical GroupLos Angeles, California, United States, 90036 Gastrointestinal Biosciences Clinical Trials, LlcLos Angeles, California, United States, 90067 Alliance Clinical Research, LlcPoway, California, United States, 92064|Colorado Springs, Colorado, United States, 80903 Peak Gastroenterology AssociatesColorado Springs, Colorado, United States, 80907|Clearwater, Florida, United States, 33756-3839 West Coast Endoscopy CenterClearwater, Florida, United States, 33756 Gastro FloridaClearwater, Florida, United States, 33762 Uf Health Jacksonville - Gastroenterology EmersonJacksonville, Florida, United States, 32207 Uf Health Jacksonville - Faculty ClinicJacksonville, Florida, United States, 32209 University Of Miami Clinical Research BuildingMiami, Florida, United States, 33136 University Of Miami Crohn'S And Colitis CenterMiami, Florida, United States, 33136 University Of Miami Hospital And ClinicsMiami, Florida, United States, 33136 University Of Miami HospitalMiami, Florida, United States, 33136 Millenia Surgery CenterOrlando, Florida, United States, 32811 Hmd Research LlcOrlando, Florida, United States, 32819|Boise, Idaho, United States, 83706 Idaho Gastroenterology AssociatesMeridian, Idaho, United States, 83642|Shawnee Mission, Kansas, United States, 66217|Houma, Louisiana, United States, 70360 Gulf Coast Surgical CenterHouma, Louisiana, United States, 70360 The Hearing Center (Audiology)Houma, Louisiana, United States, 70360|Chevy Chase, Maryland, United States, 20815 Mgg Group Co., Inc., Chevy Chase Clinical ResearchChevy Chase, Maryland, United States, 20815 Capitol ResearchRockville, Maryland, United States, 20850|Boston, Massachusetts, United States, 02115 Mass Eye And Ear, LongwoodBoston, Massachusetts, United States, 02115 Brigham And Women'S HospitalBoston, Massachusetts, United States, 02215 Brigham And Women'S HospitalChestnut Hill, Massachusetts, United States, 02467 Umass Memorial Medical CenterWorcester, Massachusetts, United States, 01655 University Of Massachusetts Medical SchoolWorcester, Massachusetts, United States, 01655|Caro, Michigan, United States, 48723 Clinical Research Institute Of Michigan, LlcChesterfield, Michigan, United States, 48047 Eastside Endoscopy CenterMacomb, Michigan, United States, 48044 Eastside Endoscopy CenterSaint Clair Shores, Michigan, United States, 48081|Ocean Springs, Mississippi, United States, 39564|New York, New York, United States, 10021 Weill Cornell Medical CollegeNew York, New York, United States, 10021 New York Presbyterian Hospital - Weill Cornell Medical College (Colonoscopy)New York, New York, United States, 10065 New York Presbyterian Hospital - Weill Cornell Medical College Investigational PharmacyNew York, New York, United States, 10065 Weill Cornell Medical College - New York Presbyterian Hospital (Endoscopy Suite)New York, New York, United States, 10065 Weill Cornell Medical College - New York Presbyterian HospitalNew York, New York, United States, 10065 Digiovanna Institute For Medical Education And ResearchNorth Massapequa, New York, United States, 11758-1853|Chapel Hill, North Carolina, United States, 27514 Unc Hospitals Endoscopy Center At MeadowmontChapel Hill, North Carolina, United States, 27517 University Of North Carolina At Chapel HillChapel Hill, North Carolina, United States, 27599 Gastroenterology Associates Of The Piedmont, PaWinston-Salem, North Carolina, United States, 27103 Pmg Research Of Winston-Salem, LlcWinston-Salem, North Carolina, United States, 27103|Oklahoma City, Oklahoma, United States, 73112|Kingsport, Tennessee, United States, 37660 Holston Valley Surgery CenterKingsport, Tennessee, United States, 37660 Vanderbilt University Medical CenterNashville, Tennessee, United States, 37212-1375 Vanderbilt University Medical CenterNashville, Tennessee, United States, 37212-1610 Vanderbilt University Medical Center - Gi Endoscopy LabNashville, Tennessee, United States, 37232-5543 Vanderbilt University Medical CenterNashville, Tennessee, United States, 37232-7610 Vanderbilt University Medical Center - Gi Research RegulatoryNashville, Tennessee, United States, 37232|Arlington, Texas, United States, 76012 Envision Imaging (Cxr)Arlington, Texas, United States, 76012 Texas Clinical Research Institiute, LlcArlington, Texas, United States, 76012 First Street HospitalBellaire, Texas, United States, 77401 First Street Surgical CenterBellaire, Texas, United States, 77401 Pearland Surgery CenterHouston, Texas, United States, 77047 Lonestar Endoscopy, LlpSouthlake, Texas, United States, 76092 Texas Digestive Disease ConsultantsSouthlake, Texas, United States, 76092|Fairfax, Virginia, United States, 22031","Alabama|California|Colorado|Florida|Idaho|Kansas|Louisiana|Maryland|Massachusetts|Michigan|Mississippi|New York|North Carolina|Oklahoma|Tennessee|Texas|Virginia","Australia|Austria|Belgium|Bosnia And Herzegovina|Canada|Croatia|Czechia|France|Georgia|Germany|Hungary|Italy|Kuwait|Lebanon|Poland|Saudi Arabia|Serbia|Slovakia|South Africa|Spain|Switzerland|Tunisia|Turkey|Ukraine|United Arab Emirates|United States","New South Wales Concord Repatriation General Hospital|Queensland Mater Misericordiae Ltd|Saint John Of God Health Care Inc.|Victoria Ballarat Base Hospital|Akh Wien Universitaetsklinik Fuer Innere Medizin Iii|University Hospital Brussels|Javna Zdravstvena Ustanova Univerzitetski Klinicki Centar Republike Srpske,|Manitoba Winnipeg Regional Health Authority - Health Sciences Centre, Winnipeg|Quebec Rocklandmd|Hrvatska Klinicki Bolnicki Centar Sestre Milosrdnice|Klinicki Bolnicki Centar Rijeka, Odjel Za Gastroenterologiju|Lekarna Altea|Hospital|The First University Clinic Of Tsmu|Paian Med Research Gmbh|Bekes Megyei Kozponti Korhaz, Rethy Pal Tagkorhaz|A.O.U. Policlinico G. Martino|Bari Irccs Saverio De Bellis|Bs A.O.Spedali Civili|Cz Univ. \"Magna Graecia\" Di Catanzaro|Mb Asst Monza|Milan Istituto Clinico Humanitas Irccs - Ibd Center|Milano Asst Rhodense - Ospedale Di Circolo Di Rho|Hospital - Dubai|Saint George Hospital University Medical Center|Niepubliczny Zaklad Opieki Zdrowotnej All-Medicus|Silesia H-T. Centrum Medyczne-Endoterapia|King Abdulaziz Medical City|Beograd Klinicko Bolnicki Centar \"Bezanijska Kosa\"|Klinicko Bolnicki Centar Zvezdara, Klinika Za Interne Bolesti,|Srbija Klinicki Centar Srbije, Klinika Za Gastroenterohepatologiju|Fakultna Nemocnica S Poliklinikou F.D. Roosevelta Banska Bystrica|, Gauteng Lenasia Clinical Trial Centre|, Western Cape Dr Wright Private Practice|Cantabria Hospital Universitario Marques De Valdecilla|Hospital Universitario Ramon Y Cajal|UniversitÃ¤tsspital ZÃ¼rich|La Rabta Hospital|Ankara Universitesi Tip Fakultesi, Ibn-I Sina Hastanesi, Ic Hastaliklari Anabilim Dali,|Regional Municipal Institution \"Chernivtsi Regional Clinical Hospital\", Gastroenterology Department,|Cleveland Clinica Abu Dhabi, Department Of Gastroenterology And Hepatology|Dothan Surgery Center|Brighton Surgical Center|Front Range Endoscopy Center|Gastro Florida|Treasure Valley Medical Research|Westglen Gastrointestinal Consultants, P.A.|Cronola, Llc|Chevy Chase Endoscopy Center|Brigham And Women's Hospital|Caro Health Plaza|Digestive Health Center|Weill Cornell Medical College (Clinical Site)|Unc Hospitals|Digestive Disease Specialists, Inc.|Holston Medical Group|Cross Timbers Surgery Center L.P. (Colonoscopy)|Verity Research, Inc.",{"$nulls":3},"Pfizer CT.gov Call Center","2020-04-28","2020-05-25T16:36:06.462","2020-05-26T17:10:42.972","NCT03395184"]
["5ecbf3f6fe30261b1a04820e","NCT03395210","2018-01-10","Principia Biopharma","PRNB","Recruiting","A Study of PRN1008 in Adult Patients With Immune Thrombocytopenic Purpura (ITP)","Prn-1008","Btk Inhibitor","Yes","['Prn-1008']","No",null,"Phase 1/Phase 2",1,24,"Anticipated","2017-12-05","2019-06-01",{"$nulls":5},"This is an adaptive, open-label, dose-finding study of PRN1008 in patients with ITP who are refractory or relapsed with no available and approved therapeutic options, with a platelet count <30,000/Î¼L on two counts no sooner than 7 days apart in the 15 days before treatment begins.","This is an adaptive, open-label, dose-finding study of PRN1008 in patients with ITP who are refractory or relapsed with no available and approved therapeutic options, with a platelet count <30,000/Î¼L on two counts no sooner than 7 days apart in the 15 days before treatment begins. The active treatment period is 12 weeks and the post-treatment follow-up period is 12 weeks. Each patient enrolled in the study is allowed to up-titrate their dose after 28 days of PRN1008 therapy, if they do not experience a platelet response or a dose-limiting toxicity (DLT) at the last dose level.","An Adaptive, Open-Label, Dose-Finding, Phase 1/2 Study Investigating the Safety, Pharmacokinetics, and Clinical Activity of PRN1008, an Oral BTK Inhibitor, in Patients With Relapsed Immune Thrombocytopenic Purpura","PRN1008-010","Immune Thrombocytopenic Purpura","Purpura|Purpura, Thrombocytopenic","Hematologic Diseases","Heme & Lymph Diseases","Experimental","PRN1008 Daily","Up to 12 weeks open-label treatment with PRN1008 daily, dose ranging from 200mg QD to 400mg BID; safety and dose evaluation, up-titration every 4 weeks","Drug","PRN1008","BTK inhibitor",null,"PRN1008 Daily","\n\n * Male or female patients, aged 18 to 80 years old\n * Immune-related ITP (both primary and secondary)\n\n","\n\n * Pregnant or lactating women\n * Current drug or alcohol abuse\n * History of solid organ transplant\n * Positive screening for HIV, hepatitis B, or hepatitis C",{"$nulls":4},"Actual","2018-01-10","Actual","Anticipated","2019-06-01","Anticipated","2018-01-01","2017-12-22","2018-01-03","2018-01-03","Yes",null,"Interventional","Treatment","Sequential Assignment","None (Open Label)","N/A","18 Years","80 Years","All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":19},"Incidence of Treatment Emergent Adverse Events (Safety Outcome Measure)|Consecutive Increased Platelet Counts (Efficacy Outcome Measure)","The incidence, severity and relationship of TEAEs during the treatment period and non-TEAEs in the 12-week follow-up period will also be assessed and examined for possible relationship to the PRN1008 treatment.|Proportion of subjects able to achieve two or more consecutive platelet counts of â‰¥ 50,000/Î¼L AND an increase of platelet count of â‰¥20,000/Î¼L from baseline, without the use of rescue medication","12 weeks of treatment and 12 weeks of follow up|12 Weeks",{"$nulls":3},"regan.burns@principiabio.com","Regan Burns","1-650-416-7700","Canton, Ohio, United States, 44718","Ohio","United States","Gabrail Cancer Center Research",{"$nulls":3},"Steven Gourlay","2018-01-03","2020-05-25T16:36:06.766","2020-05-26T17:10:42.972","NCT03395210"]
["5ecbf3f6e2561b1b11905d0a","NCT03395210","2018-08-31","Principia Biopharma","PRNB","Recruiting","A Study of PRN1008 in Adult Patients With Immune Thrombocytopenic Purpura (ITP)","Prn-1008","Btk Inhibitor","Yes","['Prn-1008']","No",null,"Phase 1/Phase 2",1,24,"Anticipated","2017-12-05","2019-06-01",{"$nulls":5},"This is an adaptive, open-label, dose-finding study of PRN1008 in patients with ITP who are refractory or relapsed with no available and approved therapeutic options, with a platelet count <30,000/Î¼L on two counts no sooner than 7 days apart in the 15 days before treatment begins.","This is an adaptive, open-label, dose-finding study of PRN1008 in patients with ITP who are refractory or relapsed with no available and approved therapeutic options, with a platelet count <30,000/Î¼L on two counts no sooner than 7 days apart in the 15 days before treatment begins. The active treatment period is 12 weeks and the post-treatment follow-up period is 12 weeks. Each patient enrolled in the study is allowed to up-titrate their dose after 28 days of PRN1008 therapy, if they do not experience a platelet response or a dose-limiting toxicity (DLT) at the last dose level.","An Adaptive, Open-Label, Dose-Finding, Phase 1/2 Study Investigating the Safety, Pharmacokinetics, and Clinical Activity of PRN1008, an Oral BTK Inhibitor, in Patients With Relapsed Immune Thrombocytopenic Purpura","PRN1008-010","Immune Thrombocytopenic Purpura","Purpura|Purpura, Thrombocytopenic","Hematologic Diseases","Heme & Lymph Diseases","Experimental","PRN1008 Daily","Up to 12 weeks open-label treatment with PRN1008 daily, dose ranging from 200mg QD to 400mg BID; safety and dose evaluation, up-titration every 4 weeks","Drug","PRN1008","BTK inhibitor",null,"PRN1008 Daily","\n\n * Male or female patients, aged 18 to 80 years old\n * Immune-related ITP (both primary and secondary)\n\n","\n\n * Pregnant or lactating women\n * Current drug or alcohol abuse\n * History of solid organ transplant\n * Positive screening for HIV, hepatitis B, or hepatitis C",{"$nulls":4},"Actual","2018-01-10","Actual","Anticipated","2019-06-01","Anticipated","2018-08-01","2017-12-22","2018-01-03","2018-08-29","Yes",null,"Interventional","Treatment","Sequential Assignment","None (Open Label)","N/A","18 Years","80 Years","All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":19},"Incidence of Treatment Emergent Adverse Events (Safety Outcome Measure)|Consecutive Increased Platelet Counts (Efficacy Outcome Measure)","The incidence, severity and relationship of TEAEs during the treatment period and non-TEAEs in the 12-week follow-up period will also be assessed and examined for possible relationship to the PRN1008 treatment.|Proportion of subjects able to achieve two or more consecutive platelet counts of â‰¥ 50,000/Î¼L AND an increase of platelet count of â‰¥20,000/Î¼L from baseline, without the use of rescue medication","12 weeks of treatment and 12 weeks of follow up|12 Weeks",{"$nulls":3},"clinicaltrials@principiabio.com","Regan Burns","1-650-416-7774","Pleven, Bulgaria, 5800 Central Recruiting (Principia Biopharma)Sofia, Bulgaria, 1233 Central Recruiting (Principia Biopharma)Varna, Bulgaria, 9010|Brno, Czechia, 625 00 Central Recruiting (Principia Biopharma)Hradec KrÃ¡lovÃ©, Czechia, 500 05 Central Recruiting (Principia Biopharma)Prague, Czechia, 128 08|Bethesda, Maryland, United States, 20817|Boston, Massachusetts, United States, 02114|Canton, Ohio, United States, 44718|San Antonio, Texas, United States, 78229","Maryland|Massachusetts|Ohio|Texas","Bulgaria|Czechia|United States","Central Recruiting (Principia Biopharma)",{"$nulls":3},"Steven Gourlay","2018-08-29","2020-05-25T16:36:06.870","2020-05-26T17:10:42.972","NCT03395210"]
["5ecbf3f6307e3d1b1f8d9c9f","NCT03395210","2018-11-01","Principia Biopharma","PRNB","Recruiting","A Study of PRN1008 in Adult Patients With Immune Thrombocytopenic Purpura (ITP)","Prn-1008","Btk Inhibitor","Yes","['Prn-1008']","No",null,"Phase 1/Phase 2",1,24,"Anticipated","2017-12-05","2019-06-01",{"$nulls":5},"This is an adaptive, open-label, dose-finding study of PRN1008 in patients with ITP who are refractory or relapsed with no available and approved therapeutic options, with a platelet count <30,000/Î¼L on two counts no sooner than 7 days apart in the 15 days before treatment begins.","This is an adaptive, open-label, dose-finding study of PRN1008 in patients with ITP who are refractory or relapsed with no available and approved therapeutic options, with a platelet count <30,000/Î¼L on two counts no sooner than 7 days apart in the 15 days before treatment begins. The active treatment period is 24 weeks and the post-treatment follow-up period is 4 weeks. Each patient enrolled in the study is allowed to up-titrate their dose after 28 days of PRN1008 therapy, if they do not experience a platelet response or a dose-limiting toxicity (DLT) at the last dose level.","An Adaptive, Open-Label, Dose-Finding, Phase 1/2 Study Investigating the Safety, Pharmacokinetics, and Clinical Activity of PRN1008, an Oral BTK Inhibitor, in Patients With Relapsed Immune Thrombocytopenic Purpura","PRN1008-010","Immune Thrombocytopenic Purpura","Purpura|Purpura, Thrombocytopenic","Hematologic Diseases","Heme & Lymph Diseases","Experimental","PRN1008 Daily","Up to 24 weeks open-label treatment with PRN1008 daily, dose ranging from 200mg QD to 400mg BID; safety and dose evaluation, up-titration every 4 weeks","Drug","PRN1008","BTK inhibitor",null,"PRN1008 Daily","\n\n * Male or female patients, aged 18 to 80 years old\n * Immune-related ITP (both primary and secondary)\n\n","\n\n * Pregnant or lactating women\n * Current drug or alcohol abuse\n * History of solid organ transplant\n * Positive screening for HIV, hepatitis B, or hepatitis C",{"$nulls":4},"Actual","2018-01-10","Actual","Anticipated","2019-12-01","Anticipated","2018-10-01","2017-12-22","2018-01-03","2018-10-30","Yes",null,"Interventional","Treatment","Sequential Assignment","None (Open Label)","N/A","18 Years","80 Years","All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":19},"Incidence of Treatment Emergent Adverse Events (Safety Outcome Measure)|Consecutive Increased Platelet Counts (Efficacy Outcome Measure)","The incidence, severity and relationship of TEAEs during the treatment period and non-TEAEs in the 4-week follow-up period will also be assessed and examined for possible relationship to the PRN1008 treatment.|Proportion of subjects able to achieve two or more consecutive platelet counts of â‰¥ 50,000/Î¼L AND an increase of platelet count of â‰¥20,000/Î¼L from baseline, without the use of rescue medication","24 weeks of treatment and 4 weeks of follow up|24 Weeks",{"$nulls":3},"clinicaltrials@principiabio.com","Regan Burns","1-833-477-6700","Pleven, Bulgaria, 5800 Central Recruiting (Principia Biopharma)Sofia, Bulgaria, 1233 Central Recruiting (Principia Biopharma)Varna, Bulgaria, 9010|Brno, Czechia, 625 00 Central Recruiting (Principia Biopharma)Hradec KrÃ¡lovÃ©, Czechia, 500 05 Central Recruiting (Principia Biopharma)Ostrava, Czechia, 70852 Central Recruiting (Principia Biopharma)Prague, Czechia, 128 08|London, England, United Kingdom|Bethesda, Maryland, United States, 20817|Boston, Massachusetts, United States, 02114|New York, New York, United States, 10065|Canton, Ohio, United States, 44718|San Antonio, Texas, United States, 78229","Maryland|Massachusetts|New York|Ohio|Texas","Bulgaria|Czechia|United Kingdom|United States","Central Recruiting (Principia Biopharma)|, England Central Recruiting (Principia Biopharma)|Central Recruiting By Principia Biopharma",{"$nulls":3},"Olga Bandman, MD","2018-10-30","2020-05-25T16:36:06.786","2020-05-26T17:10:42.972","NCT03395210"]
["5ecbf3f6feab101b1553083f","NCT03395210","2019-01-03","Principia Biopharma","PRNB","Recruiting","A Study of PRN1008 in Adult Patients With Immune Thrombocytopenic Purpura (ITP)","Prn-1008","Btk Inhibitor","Yes","['Prn-1008']","No",null,"Phase 1/Phase 2",1,24,"Anticipated","2017-12-05","2019-06-01",{"$nulls":5},"This is an adaptive, open-label, dose-finding study of PRN1008 in patients with ITP who are refractory or relapsed with no available and approved therapeutic options, with a platelet count <30,000/Î¼L on two counts no sooner than 7 days apart in the 15 days before treatment begins.","This is an adaptive, open-label, dose-finding study of PRN1008 in patients with ITP who are refractory or relapsed with no available and approved therapeutic options, with a platelet count <30,000/Î¼L on two counts no sooner than 7 days apart in the 15 days before treatment begins. The active treatment period is 24 weeks and the post-treatment follow-up period is 4 weeks. Each patient enrolled in the study is allowed to up-titrate their dose after 28 days of PRN1008 therapy, if they do not experience a platelet response or a dose-limiting toxicity (DLT) at the last dose level.","An Adaptive, Open-Label, Dose-Finding, Phase 1/2 Study Investigating the Safety, Pharmacokinetics, and Clinical Activity of PRN1008, an Oral BTK Inhibitor, in Patients With Relapsed Immune Thrombocytopenic Purpura","PRN1008-010","Immune Thrombocytopenic Purpura","Purpura|Purpura, Thrombocytopenic","Hematologic Diseases","Heme & Lymph Diseases","Experimental","PRN1008 Daily","Up to 24 weeks open-label treatment with PRN1008 daily, dose ranging from 200mg QD to 400mg BID; safety and dose evaluation, up-titration every 4 weeks","Drug","PRN1008","BTK inhibitor",null,"PRN1008 Daily","\n\n * Male or female patients, aged 18 to 80 years old\n * Immune-related ITP (both primary and secondary)\n\n","\n\n * Pregnant or lactating women\n * Current drug or alcohol abuse\n * History of solid organ transplant\n * Positive screening for HIV, hepatitis B, or hepatitis C",{"$nulls":4},"Actual","2018-01-10","Actual","Anticipated","2019-12-01","Anticipated","2018-12-01","2017-12-22","2018-01-03","2018-12-31","Yes",null,"Interventional","Treatment","Sequential Assignment","None (Open Label)","N/A","18 Years","80 Years","All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":19},"Incidence of Treatment Emergent Adverse Events (Safety Outcome Measure)|Consecutive Increased Platelet Counts (Efficacy Outcome Measure)","The incidence, severity and relationship of TEAEs during the treatment period and non-TEAEs in the 4-week follow-up period will also be assessed and examined for possible relationship to the PRN1008 treatment.|Proportion of subjects able to achieve two or more consecutive platelet counts of â‰¥ 50,000/Î¼L AND an increase of platelet count of â‰¥20,000/Î¼L from baseline, without the use of rescue medication","24 weeks of treatment and 4 weeks of follow up|24 Weeks",{"$nulls":3},"clinicaltrials@principiabio.com","Regan Burns","1-833-477-6700","Pleven, Bulgaria, 5800 Central Recruiting (Principia Biopharma)Sofia, Bulgaria, 1233 Central Recruiting (Principia Biopharma)Varna, Bulgaria, 9010|Brno, Czechia, 625 00 Central Recruiting (Principia Biopharma)Hradec KrÃ¡lovÃ©, Czechia, 500 05 Central Recruiting (Principia Biopharma)Ostrava, Czechia, 70852 Central Recruiting (Principia Biopharma)Prague, Czechia, 128 08|London, England, United Kingdom|Bethesda, Maryland, United States, 20817|Boston, Massachusetts, United States, 02114|Midland, Michigan, United States, 48670|New York, New York, United States, 10065|Canton, Ohio, United States, 44718|San Antonio, Texas, United States, 78229","Maryland|Massachusetts|Michigan|New York|Ohio|Texas","Bulgaria|Czechia|United Kingdom|United States","Central Recruiting (Principia Biopharma)|, England Central Recruiting (Principia Biopharma)|Central Recruiting By Principia Biopharma",{"$nulls":3},"Olga Bandman, MD","2018-12-31","2020-05-25T16:36:06.878","2020-05-26T17:10:42.972","NCT03395210"]
["5ecbf3f6307e3d1b1f8d9ca0","NCT03395210","2019-01-30","Principia Biopharma","PRNB","Recruiting","A Study of PRN1008 in Adult Patients With Immune Thrombocytopenic Purpura (ITP)","Prn-1008","Btk Inhibitor","Yes","['Prn-1008']","No",null,"Phase 1/Phase 2",1,24,"Anticipated","2017-12-05","2019-06-01",{"$nulls":5},"This is an adaptive, open-label, dose-finding study of PRN1008 in patients with ITP who are refractory or relapsed with no available and approved therapeutic options, with a platelet count <30,000/Î¼L on two counts no sooner than 7 days apart in the 15 days before treatment begins.","This is an adaptive, open-label, dose-finding study of PRN1008 in patients with ITP who are refractory or relapsed with no available and approved therapeutic options, with a platelet count <30,000/Î¼L on two counts no sooner than 7 days apart in the 15 days before treatment begins. The active treatment period is 24 weeks and the post-treatment follow-up period is 4 weeks. Each patient enrolled in the study is allowed to up-titrate their dose after 28 days of PRN1008 therapy, if they do not experience a platelet response or a dose-limiting toxicity (DLT) at the last dose level.","An Adaptive, Open-Label, Dose-Finding, Phase 1/2 Study Investigating the Safety, Pharmacokinetics, and Clinical Activity of PRN1008, an Oral BTK Inhibitor, in Patients With Relapsed Immune Thrombocytopenic Purpura","PRN1008-010","Immune Thrombocytopenic Purpura","Purpura|Purpura, Thrombocytopenic","Hematologic Diseases","Heme & Lymph Diseases","Experimental","PRN1008 Daily","Up to 24 weeks open-label treatment with PRN1008 daily, dose ranging from 200mg QD to 400mg BID; safety and dose evaluation, up-titration every 4 weeks","Drug","PRN1008","BTK inhibitor",null,"PRN1008 Daily","\n\n * Male or female patients, aged 18 to 80 years old\n * Immune-related ITP (both primary and secondary)\n\n","\n\n * Pregnant or lactating women\n * Current drug or alcohol abuse\n * History of solid organ transplant\n * Positive screening for HIV, hepatitis B, or hepatitis C",{"$nulls":4},"Actual","2018-01-10","Actual","Anticipated","2019-12-01","Anticipated","2019-01-01","2017-12-22","2018-01-03","2019-01-28","Yes",null,"Interventional","Treatment","Sequential Assignment","None (Open Label)","N/A","18 Years","80 Years","All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":19},"Incidence of Treatment Emergent Adverse Events (Safety Outcome Measure)|Consecutive Increased Platelet Counts (Efficacy Outcome Measure)","The incidence, severity and relationship of TEAEs during the treatment period and non-TEAEs in the 4-week follow-up period will also be assessed and examined for possible relationship to the PRN1008 treatment.|Proportion of subjects able to achieve two or more consecutive platelet counts of â‰¥ 50,000/Î¼L AND an increase of platelet count of â‰¥20,000/Î¼L from baseline, without the use of rescue medication","24 weeks of treatment and 4 weeks of follow up|24 Weeks",{"$nulls":3},"clinicaltrials@principiabio.com","Regan Burns","1-833-477-6700","Pleven, Bulgaria, 5800 Central Recruiting (Principia Biopharma)Sofia, Bulgaria, 1233 Central Recruiting (Principia Biopharma)Varna, Bulgaria, 9010|Brno, Czechia, 625 00 Central Recruiting (Principia Biopharma)Hradec KrÃ¡lovÃ©, Czechia, 500 05 Central Recruiting (Principia Biopharma)Ostrava, Czechia, 70852 Central Recruiting (Principia Biopharma)Prague, Czechia, 128 08|London, England, United Kingdom|Leicester, United Kingdom, Le1 5Ww|Peoria, Illinois, United States, 61615|Bethesda, Maryland, United States, 20817|Boston, Massachusetts, United States, 02114|Midland, Michigan, United States, 48670|New York, New York, United States, 10065|Canton, Ohio, United States, 44718|San Antonio, Texas, United States, 78229","Illinois|Maryland|Massachusetts|Michigan|New York|Ohio|Texas","Bulgaria|Czechia|United Kingdom|United States","Central Recruiting (Principia Biopharma)|, England Central Recruiting (Principia Biopharma)|Central Recruiting By Principia Biopharma",{"$nulls":3},"Olga Bandman, MD","2019-01-28","2020-05-25T16:36:06.886","2020-05-26T17:10:42.972","NCT03395210"]
["5ecbf3f7e2561b1b11905d0b","NCT03395210","2019-08-01","Principia Biopharma","PRNB","Recruiting","A Study of PRN1008 in Adult Patients With Immune Thrombocytopenic Purpura (ITP)","Prn-1008","Btk Inhibitor","Yes","['Prn-1008']","No",null,"Phase 1/Phase 2",1,40,"Anticipated","2017-12-05","2021-06-01",{"$nulls":5},"This is an adaptive, open-label, dose-finding study of PRN1008 in patients with ITP who are refractory or relapsed with no available and approved therapeutic options, with a platelet count <30,000/Î¼L on two counts no sooner than 7 days apart in the 15 days before treatment begins.","This is an adaptive, open-label, dose-finding study of PRN1008 in up to 40 patients with ITP who are refractory or relapsed with no available and approved therapeutic options, with a platelet count <30,000/Î¼L on two counts no sooner than 7 days apart in the 15 days before treatment begins. The active treatment period is 24 weeks and the post-treatment follow-up period is 4 weeks. Each patient enrolled in the study is allowed to up-titrate their dose after 28 days of PRN1008 therapy, if they do not experience a platelet response or a dose-limiting toxicity (DLT) at the last dose level. Patients who respond to PRN1008 per protocol may enter a long term extension.","An Adaptive, Open-Label, Dose-Finding, Phase 1/2 Study Investigating the Safety, Pharmacokinetics, and Clinical Activity of PRN1008, an Oral BTK Inhibitor, in Patients With Relapsed Immune Thrombocytopenic Purpura","PRN1008-010","Immune Thrombocytopenic Purpura","Purpura|Purpura, Thrombocytopenic","Hematologic Diseases","Heme & Lymph Diseases","Experimental","PRN1008 Daily","Up to 24 weeks open-label treatment with PRN1008 daily, dose ranging from 200mg QD to 400mg BID; safety and dose evaluation, up-titration every 4 weeks. Patients who respond to PRN1008 per protocol may enter a long term extension.","Drug","PRN1008","BTK inhibitor",null,"PRN1008 Daily","\n\n * Male or female patients, aged 18 to 80 years old\n * Immune-related ITP (both primary and secondary)\n\n","\n\n * Pregnant or lactating women\n * Current drug or alcohol abuse\n * History of solid organ transplant\n * Positive screening for HIV, hepatitis B, or hepatitis C",{"$nulls":4},"Actual","2018-01-10","Actual","Anticipated","2021-12-01","Anticipated","2019-07-01","2017-12-22","2018-01-03","2019-07-30","Yes",null,"Interventional","Treatment","Sequential Assignment","None (Open Label)","N/A","18 Years","80 Years","All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":19},"Incidence of Treatment Emergent Adverse Events (Safety Outcome Measure)|Consecutive Increased Platelet Counts (Efficacy Outcome Measure)","The incidence, severity and relationship of TEAEs during the treatment period and TEAEs in the 4-week follow-up period will also be assessed and examined for possible relationship to the PRN1008 treatment.|Proportion of subjects able to achieve two or more consecutive platelet counts of â‰¥ 50,000/Î¼L AND an increase of platelet count of â‰¥20,000/Î¼L from baseline, without the use of rescue medication","24 weeks of treatment, long term extension and 4 weeks of follow up|24 Weeks",{"$nulls":3},"clinicaltrials@principiabio.com","Regan Burns","1-833-477-6700","Concord, New South Wales, Australia, 2139|Brisbane, Queensland, Australia, 4102|Clayton, Victoria, Australia, 3168|Pleven, Bulgaria, 5800 Central Recruiting (Principia Biopharma)Sofia, Bulgaria, 1233 Central Recruiting (Principia Biopharma)Varna, Bulgaria, 9010|Toronto, Ontario, Canada, M5B 1W8|Brno, Czechia, 625 00 Central Recruiting (Principia Biopharma)Hradec KrÃ¡lovÃ©, Czechia, 500 05 Central Recruiting (Principia Biopharma)Ostrava, Czechia, 70852 Central Recruiting (Principia Biopharma)Prague, Czechia, 128 08|Rotterdam, Netherlands, 3015 Gd|Bergen, Norway Central Recruiting (Principia Biopharma)GrÃ¥lum, Norway, 1714|London, England, United Kingdom|Leicester, United Kingdom, Le1 5Ww|Peoria, Illinois, United States, 61615|Bethesda, Maryland, United States, 20817|Boston, Massachusetts, United States, 02114|Midland, Michigan, United States, 48670|New York, New York, United States, 10065|Greenville, North Carolina, United States, 27834|San Antonio, Texas, United States, 78229|Seattle, Washington, United States, 98109","Illinois|Maryland|Massachusetts|Michigan|New York|North Carolina|Texas|Washington","Australia|Bulgaria|Canada|Czechia|Netherlands|Norway|United Kingdom|United States","New South Wales Central Recruiting (Principia Biopharma)|Queensland Central Recruiting (Principia Biopharma)|Victoria Central Recruiting (Principia Biopharma)|Central Recruiting (Principia Biopharma)|Ontario Central Recruiting (Principia Biopharma)|, England Central Recruiting (Principia Biopharma)|Central Recruiting By Principia Biopharma",{"$nulls":3},"Olga Bandman, MD","2019-07-30","2020-05-25T16:36:07.191","2020-05-26T17:10:42.972","NCT03395210"]
["5ecbf3f711702c1b1b916a20","NCT03395210","2019-09-06","Principia Biopharma","PRNB","Recruiting","A Study of PRN1008 in Adult Patients With Immune Thrombocytopenic Purpura (ITP)","Prn-1008","Btk Inhibitor","Yes","['Prn-1008']","No",null,"Phase 1/Phase 2",1,40,"Anticipated","2017-12-05","2021-06-01",{"$nulls":5},"This is an adaptive, open-label, dose-finding study of PRN1008 in patients with ITP who are refractory or relapsed with no available and approved therapeutic options, with a platelet count <30,000/Î¼L on two counts no sooner than 7 days apart in the 15 days before treatment begins.","This is an adaptive, open-label, dose-finding study of PRN1008 in up to 40 patients with ITP who are refractory or relapsed with no available and approved therapeutic options, with a platelet count <30,000/Î¼L on two counts no sooner than 7 days apart in the 15 days before treatment begins. The active treatment period is 24 weeks and the post-treatment follow-up period is 4 weeks. Each patient enrolled in the study is allowed to up-titrate their dose after 28 days of PRN1008 therapy, if they do not experience a platelet response or a dose-limiting toxicity (DLT) at the last dose level. Patients who respond to PRN1008 per protocol may enter a long term extension.","An Adaptive, Open-Label, Dose-Finding, Phase 1/2 Study Investigating the Safety, Pharmacokinetics, and Clinical Activity of PRN1008, an Oral BTK Inhibitor, in Patients With Relapsed Immune Thrombocytopenic Purpura","PRN1008-010","Immune Thrombocytopenic Purpura","Purpura|Purpura, Thrombocytopenic","Hematologic Diseases","Heme & Lymph Diseases","Experimental","PRN1008 Daily","Up to 24 weeks open-label treatment with PRN1008 daily, dose ranging from 200mg QD to 400mg BID; safety and dose evaluation, up-titration every 4 weeks. Patients who respond to PRN1008 per protocol may enter a long term extension.","Drug","PRN1008","BTK inhibitor",null,"PRN1008 Daily","\n\n * Male or female patients, aged 18 to 80 years old\n * Immune-related ITP (both primary and secondary)\n\n","\n\n * Pregnant or lactating women\n * Current drug or alcohol abuse\n * History of solid organ transplant\n * Positive screening for HIV, hepatitis B, or hepatitis C",{"$nulls":4},"Actual","2018-01-10","Actual","Anticipated","2021-12-01","Anticipated","2019-09-01","2017-12-22","2018-01-03","2019-09-04","Yes",null,"Interventional","Treatment","Sequential Assignment","None (Open Label)","N/A","18 Years","80 Years","All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":19},"Incidence of Treatment Emergent Adverse Events (Safety Outcome Measure)|Consecutive Increased Platelet Counts (Efficacy Outcome Measure)","The incidence, severity and relationship of TEAEs during the treatment period and TEAEs in the 4-week follow-up period will also be assessed and examined for possible relationship to the PRN1008 treatment.|Proportion of subjects able to achieve two or more consecutive platelet counts of â‰¥ 50,000/Î¼L AND an increase of platelet count of â‰¥20,000/Î¼L from baseline, without the use of rescue medication","24 weeks of treatment, long term extension and 4 weeks of follow up|24 Weeks",{"$nulls":3},"clinicaltrials@principiabio.com","Regan Burns","1-833-477-6700","Concord, New South Wales, Australia, 2139|Brisbane, Queensland, Australia, 4102|Clayton, Victoria, Australia, 3168|Pleven, Bulgaria, 5800 Central Recruiting (Principia Biopharma)Sofia, Bulgaria, 1233 Central Recruiting (Principia Biopharma)Varna, Bulgaria, 9010|Toronto, Ontario, Canada, M5B 1W8|Brno, Czechia, 625 00 Central Recruiting (Principia Biopharma)Hradec KrÃ¡lovÃ©, Czechia, 500 05 Central Recruiting (Principia Biopharma)Ostrava, Czechia, 70852 Central Recruiting (Principia Biopharma)Prague, Czechia, 128 08|Rotterdam, Netherlands, 3015 Gd|Bergen, Norway Central Recruiting (Principia Biopharma)GrÃ¥lum, Norway, 1714|London, England, United Kingdom|Leicester, United Kingdom, Le1 5Ww|Peoria, Illinois, United States, 61615|Bethesda, Maryland, United States, 20817|Boston, Massachusetts, United States, 02114|Midland, Michigan, United States, 48670|New York, New York, United States, 10065|Greenville, North Carolina, United States, 27834|San Antonio, Texas, United States, 78229|Seattle, Washington, United States, 98109","Illinois|Maryland|Massachusetts|Michigan|New York|North Carolina|Texas|Washington","Australia|Bulgaria|Canada|Czechia|Netherlands|Norway|United Kingdom|United States","New South Wales Central Recruiting (Principia Biopharma)|Queensland Central Recruiting (Principia Biopharma)|Victoria Central Recruiting (Principia Biopharma)|Central Recruiting (Principia Biopharma)|Ontario Central Recruiting (Principia Biopharma)|, England Central Recruiting (Principia Biopharma)|Central Recruiting By Principia Biopharma",{"$nulls":3},"Olga Bandman, MD","2019-09-04","2020-05-25T16:36:07.271","2020-05-26T17:10:42.972","NCT03395210"]
["5ecbf3f7fe30261b1a04820f","NCT03395210","2019-10-02","Principia Biopharma","PRNB","Recruiting","A Study of PRN1008 in Adult Patients With Immune Thrombocytopenic Purpura (ITP)","Prn-1008","Btk Inhibitor","Yes","['Prn-1008']","No",null,"Phase 1/Phase 2",1,40,"Anticipated","2017-12-05","2021-06-01",{"$nulls":5},"This is an adaptive, open-label, dose-finding study of PRN1008 in patients with ITP who are refractory or relapsed with no available and approved therapeutic options, with a platelet count <30,000/Î¼L on two counts no sooner than 7 days apart in the 15 days before treatment begins.","This is an adaptive, open-label, dose-finding study of PRN1008 in up to 40 patients with ITP who are refractory or relapsed with no available and approved therapeutic options, with a platelet count <30,000/Î¼L on two counts no sooner than 7 days apart in the 15 days before treatment begins. The active treatment period is 24 weeks and the post-treatment follow-up period is 4 weeks. Each patient enrolled in the study is allowed to up-titrate their dose after 28 days of PRN1008 therapy, if they do not experience a platelet response or a dose-limiting toxicity (DLT) at the last dose level. Patients who respond to PRN1008 per protocol may enter a long term extension.","An Adaptive, Open-Label, Dose-Finding, Phase 1/2 Study Investigating the Safety, Pharmacokinetics, and Clinical Activity of PRN1008, an Oral BTK Inhibitor, in Patients With Relapsed Immune Thrombocytopenic Purpura","PRN1008-010","Immune Thrombocytopenic Purpura","Purpura|Purpura, Thrombocytopenic","Hematologic Diseases","Heme & Lymph Diseases","Experimental","PRN1008 Daily","Up to 24 weeks open-label treatment with PRN1008 daily, dose ranging from 200mg QD to 400mg BID; safety and dose evaluation, up-titration every 4 weeks. Patients who respond to PRN1008 per protocol may enter a long term extension.","Drug","PRN1008","BTK inhibitor",null,"PRN1008 Daily","\n\n * Male or female patients, aged 18 to 80 years old\n * Immune-related ITP (both primary and secondary)\n\n","\n\n * Pregnant or lactating women\n * Current drug or alcohol abuse\n * History of solid organ transplant\n * Positive screening for HIV, hepatitis B, or hepatitis C",{"$nulls":4},"Actual","2018-01-10","Actual","Anticipated","2021-12-01","Anticipated","2019-09-01","2017-12-22","2018-01-03","2019-09-30","Yes",null,"Interventional","Treatment","Sequential Assignment","None (Open Label)","N/A","18 Years","80 Years","All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":19},"Incidence of Treatment Emergent Adverse Events (Safety Outcome Measure)|Consecutive Increased Platelet Counts (Efficacy Outcome Measure)","The incidence, severity and relationship of TEAEs during the treatment period and TEAEs in the 4-week follow-up period will also be assessed and examined for possible relationship to the PRN1008 treatment.|Proportion of subjects able to achieve two or more consecutive platelet counts of â‰¥ 50,000/Î¼L AND an increase of platelet count of â‰¥20,000/Î¼L from baseline, without the use of rescue medication","24 weeks of treatment, long term extension and 4 weeks of follow up|24 Weeks",{"$nulls":3},"clinicaltrials@principiabio.com","Regan Burns","1-833-477-6700","Concord, New South Wales, Australia, 2139|Brisbane, Queensland, Australia, 4102|Clayton, Victoria, Australia, 3168|Pleven, Bulgaria, 5800 Central Recruiting (Principia Biopharma)Sofia, Bulgaria, 1233 Central Recruiting (Principia Biopharma)Varna, Bulgaria, 9010|Toronto, Ontario, Canada, M5B 1W8|Brno, Czechia, 625 00 Central Recruiting (Principia Biopharma)Hradec KrÃ¡lovÃ©, Czechia, 500 05 Central Recruiting (Principia Biopharma)Ostrava, Czechia, 70852 Central Recruiting (Principia Biopharma)Prague, Czechia, 128 08|Rotterdam, Netherlands, 3015 Gd|Bergen, Norway Central Recruiting (Principia Biopharma)GrÃ¥lum, Norway, 1714|London, England, United Kingdom|Leicester, United Kingdom, Le1 5Ww|Peoria, Illinois, United States, 61615|Bethesda, Maryland, United States, 20817|Boston, Massachusetts, United States, 02114|Midland, Michigan, United States, 48670|New York, New York, United States, 10065|Greenville, North Carolina, United States, 27834|San Antonio, Texas, United States, 78229|Seattle, Washington, United States, 98109","Illinois|Maryland|Massachusetts|Michigan|New York|North Carolina|Texas|Washington","Australia|Bulgaria|Canada|Czechia|Netherlands|Norway|United Kingdom|United States","New South Wales Central Recruiting (Principia Biopharma)|Queensland Central Recruiting (Principia Biopharma)|Victoria Central Recruiting (Principia Biopharma)|Central Recruiting (Principia Biopharma)|Ontario Central Recruiting (Principia Biopharma)|, England Central Recruiting (Principia Biopharma)|Central Recruiting By Principia Biopharma",{"$nulls":3},"Olga Bandman, MD","2019-09-30","2020-05-25T16:36:07.241","2020-05-26T17:10:42.972","NCT03395210"]
["5ecbf3f711702c1b1b916a21","NCT03395210","2019-11-06","Principia Biopharma","PRNB","Recruiting","A Study of PRN1008 in Adult Patients With Immune Thrombocytopenic Purpura (ITP)","Prn-1008","Btk Inhibitor","Yes","['Prn-1008']","No",null,"Phase 1/Phase 2",1,40,"Anticipated","2017-12-05","2021-06-01",{"$nulls":5},"This is an adaptive, open-label, dose-finding study of PRN1008 in patients with ITP who are refractory or relapsed with no available and approved therapeutic options, with a platelet count <30,000/Î¼L on two counts no sooner than 7 days apart in the 15 days before treatment begins.","This is an adaptive, open-label, dose-finding study of PRN1008 in up to 40 patients with ITP who are refractory or relapsed with no available and approved therapeutic options, with a platelet count <30,000/Î¼L on two counts no sooner than 7 days apart in the 15 days before treatment begins. The active treatment period is 24 weeks and the post-treatment follow-up period is 4 weeks. Each patient enrolled in the study is allowed to up-titrate their dose after 28 days of PRN1008 therapy, if they do not experience a platelet response or a dose-limiting toxicity (DLT) at the last dose level. Patients who respond to PRN1008 per protocol may enter a long term extension.","An Adaptive, Open-Label, Dose-Finding, Phase 1/2 Study Investigating the Safety, Pharmacokinetics, and Clinical Activity of PRN1008, an Oral BTK Inhibitor, in Patients With Relapsed Immune Thrombocytopenic Purpura","PRN1008-010","Immune Thrombocytopenic Purpura","Purpura|Purpura, Thrombocytopenic","Hematologic Diseases","Heme & Lymph Diseases","Experimental","PRN1008 Daily","Up to 24 weeks open-label treatment with PRN1008 daily, dose ranging from 200mg QD to 400mg BID; safety and dose evaluation, up-titration every 4 weeks. Patients who respond to PRN1008 per protocol may enter a long term extension.","Drug","PRN1008","BTK inhibitor",null,"PRN1008 Daily","\n\n * Male or female patients, aged 18 to 80 years old\n * Immune-related ITP (both primary and secondary)\n\n","\n\n * Pregnant or lactating women\n * Current drug or alcohol abuse\n * History of solid organ transplant\n * Positive screening for HIV, hepatitis B, or hepatitis C",{"$nulls":4},"Actual","2018-01-10","Actual","Anticipated","2021-12-01","Anticipated","2019-11-01","2017-12-22","2018-01-03","2019-11-05","Yes",null,"Interventional","Treatment","Sequential Assignment","None (Open Label)","N/A","18 Years","80 Years","All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":19},"Incidence of Treatment Emergent Adverse Events (Safety Outcome Measure)|Consecutive Increased Platelet Counts (Efficacy Outcome Measure)","The incidence, severity and relationship of TEAEs during the treatment period and TEAEs in the 4-week follow-up period will also be assessed and examined for possible relationship to the PRN1008 treatment.|Proportion of subjects able to achieve two or more consecutive platelet counts of â‰¥ 50,000/Î¼L AND an increase of platelet count of â‰¥20,000/Î¼L from baseline, without the use of rescue medication","24 weeks of treatment, long term extension and 4 weeks of follow up|24 Weeks",{"$nulls":3},"clinicaltrials@principiabio.com","Regan Burns","1-833-477-6700","Nedlands, Western|Concord, New South Wales, Australia, 2139|Brisbane, Queensland, Australia, 4102|Clayton, Victoria, Australia, 3168|Pleven, Bulgaria, 5800 Central Recruiting (Principia Biopharma)Sofia, Bulgaria, 1233 Central Recruiting (Principia Biopharma)Varna, Bulgaria, 9010|Toronto, Ontario, Canada, M5B 1W8|Brno, Czechia, 625 00 Central Recruiting (Principia Biopharma)Hradec KrÃ¡lovÃ©, Czechia, 500 05 Central Recruiting (Principia Biopharma)Ostrava, Czechia, 70852 Central Recruiting (Principia Biopharma)Prague, Czechia, 128 08|Rotterdam, Netherlands, 3015 Gd|The Hague, South Holland, Netherlands, 2545Ch|Bergen, Norway Central Recruiting (Principia Biopharma)GrÃ¥lum, Norway, 1714|London, England, United Kingdom|Leicester, United Kingdom, Le1 5Ww|Peoria, Illinois, United States, 61615|Bethesda, Maryland, United States, 20817|Boston, Massachusetts, United States, 02114|Midland, Michigan, United States, 48670|New York, New York, United States, 10065|Greenville, North Carolina, United States, 27834|Seattle, Washington, United States, 98109","Illinois|Maryland|Massachusetts|Michigan|New York|North Carolina|Washington","Australia|Bulgaria|Canada|Czechia|Netherlands|Norway|United Kingdom|United States","Central Recruiting (Principia Biopharma)|New South Wales Central Recruiting (Principia Biopharma)|Queensland Central Recruiting (Principia Biopharma)|Victoria Central Recruiting (Principia Biopharma)|Ontario Central Recruiting (Principia Biopharma)|South Holland Central Recruiting (Principia Biopharma)|, England Central Recruiting (Principia Biopharma)|Central Recruiting By Principia Biopharma",{"$nulls":3},"Olga Bandman, MD","2019-11-05","2020-05-25T16:36:07.504","2020-05-26T17:10:42.972","NCT03395210"]
["5ecbf3f7fe30261b1a048210","NCT03395210","2019-12-10","Principia Biopharma","PRNB","Recruiting","A Study of PRN1008 in Adult Patients With Immune Thrombocytopenic Purpura (ITP)","Prn-1008","Btk Inhibitor","Yes","['Prn-1008']","No",null,"Phase 1/Phase 2",1,40,"Anticipated","2017-12-05","2021-06-01",{"$nulls":5},"This is an adaptive, open-label, dose-finding study of PRN1008 in patients with ITP who are refractory or relapsed with no available and approved therapeutic options, with a platelet count <30,000/Î¼L on two counts no sooner than 7 days apart in the 15 days before treatment begins.","This is an adaptive, open-label, dose-finding study of PRN1008 in up to 40 patients with ITP who are refractory or relapsed with no available and approved therapeutic options, with a platelet count <30,000/Î¼L on two counts no sooner than 7 days apart in the 15 days before treatment begins. The active treatment period is 24 weeks and the post-treatment follow-up period is 4 weeks. Each patient enrolled in the study is allowed to up-titrate their dose after 28 days of PRN1008 therapy, if they do not experience a platelet response or a dose-limiting toxicity (DLT) at the last dose level. Patients who respond to PRN1008 per protocol may enter a long term extension.","An Adaptive, Open-Label, Dose-Finding, Phase 1/2 Study Investigating the Safety, Pharmacokinetics, and Clinical Activity of PRN1008, an Oral BTK Inhibitor, in Patients With Relapsed Immune Thrombocytopenic Purpura","PRN1008-010","Immune Thrombocytopenic Purpura","Purpura|Purpura, Thrombocytopenic","Hematologic Diseases","Heme & Lymph Diseases","Experimental","PRN1008 Daily","Up to 24 weeks open-label treatment with PRN1008 daily, dose ranging from 200mg QD to 400mg BID; safety and dose evaluation, up-titration every 4 weeks. Patients who respond to PRN1008 per protocol may enter a long term extension.","Drug","PRN1008","BTK inhibitor",null,"PRN1008 Daily","\n\n * Male or female patients, aged 18 to 80 years old\n * Immune-related ITP (both primary and secondary)\n\n","\n\n * Pregnant or lactating women\n * Current drug or alcohol abuse\n * History of solid organ transplant\n * Positive screening for HIV, hepatitis B, or hepatitis C",{"$nulls":4},"Actual","2018-01-10","Actual","Anticipated","2021-12-01","Anticipated","2019-12-01","2017-12-22","2018-01-03","2019-12-09","Yes",null,"Interventional","Treatment","Sequential Assignment","None (Open Label)","N/A","18 Years","80 Years","All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":19},"Incidence of Treatment Emergent Adverse Events (Safety Outcome Measure)|Consecutive Increased Platelet Counts (Efficacy Outcome Measure)","The incidence, severity and relationship of TEAEs during the treatment period and TEAEs in the 4-week follow-up period will also be assessed and examined for possible relationship to the PRN1008 treatment.|Proportion of subjects able to achieve two or more consecutive platelet counts of â‰¥ 50,000/Î¼L AND an increase of platelet count of â‰¥20,000/Î¼L from baseline, without the use of rescue medication","24 weeks of treatment, long term extension and 4 weeks of follow up|24 Weeks",{"$nulls":3},"clinicaltrials@principiabio.com","Regan Burns","1-833-477-6700","Garran, Australia Capital Territory, Australia|Nedlands, Western|Concord, New South Wales, Australia, 2139|Brisbane, Queensland, Australia, 4102|Clayton, Victoria, Australia, 3168|Pleven, Bulgaria, 5800 Central Recruiting (Principia Biopharma)Sofia, Bulgaria, 1233 Central Recruiting (Principia Biopharma)Varna, Bulgaria, 9010|Toronto, Ontario, Canada, M5B 1W8|MontrÃ©al, Quebec, Canada|Brno, Czechia, 625 00 Central Recruiting (Principia Biopharma)Hradec KrÃ¡lovÃ©, Czechia, 500 05 Central Recruiting (Principia Biopharma)Ostrava, Czechia, 70852 Central Recruiting (Principia Biopharma)Prague, Czechia, 128 08|Rotterdam, Netherlands, 3015 Gd|The Hague, South Holland, Netherlands, 2545Ch|Bergen, Norway Central Recruiting (Principia Biopharma)GrÃ¥lum, Norway, 1714|London, England, United Kingdom|Leicester, United Kingdom, Le1 5Ww|Peoria, Illinois, United States, 61615|Bethesda, Maryland, United States, 20817|Boston, Massachusetts, United States, 02114|Midland, Michigan, United States, 48670|New York, New York, United States, 10065|Greenville, North Carolina, United States, 27834|Seattle, Washington, United States, 98109","Illinois|Maryland|Massachusetts|Michigan|New York|North Carolina|Washington","Australia|Bulgaria|Canada|Czechia|Netherlands|Norway|United Kingdom|United States","Australia| Capital Territory Central Recruting (Principia Biopharma)|Central Recruiting (Principia Biopharma)|New South Wales Central Recruiting (Principia Biopharma)|Queensland Central Recruiting (Principia Biopharma)|Victoria Central Recruiting (Principia Biopharma)|Ontario Central Recruiting (Principia Biopharma)|Quebec Central Recruting (Principia Biopharma)|South Holland Central Recruiting (Principia Biopharma)|, England Central Recruiting (Principia Biopharma)|Central Recruiting By Principia Biopharma",{"$nulls":3},"Olga Bandman, MD","2019-12-09","2020-05-25T16:36:07.296","2020-05-26T17:10:42.972","NCT03395210"]
["5ecbf3f8feab101b15530843","NCT03395470","2018-01-10","Poxel","PXXLF","Recruiting","Safety, Tolerability and PK of PXL770 in Healthy Male Subjects","Pxl-770|Rosuvastatin","AMPK Activator|HMG-CoA Inhibitor","Yes","['Pxl-770']","Yes","['AMPK Activator']","Phase 1",6,52,"Anticipated","2017-08-21","2018-05-13",{"$nulls":5},"PXL770 is a direct activator of 5' adenosine monophosphate-activated protein kinase (AMPK) being developed by Poxel S.A. for the treatment of type 2 diabetes mellitus (T2DM). In Part A of this study, we'll test the safety, tolerability and pharmacokinetics (PK) of repeated doses. In Part B, we'll co-administer PXL770 and rosuvastatin (a HMG-CoA reductase inhibitor) to assess any drug-drug interaction.",null,"A Double-blind, Randomised, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Doses of PXL770, Including an Open-label, One-sequence Part to Assess the Drug-drug Interaction With Rosuvastatin in Healthy Male Subjects","PXL770-002","Metabolic Disease","Healthy Volunteers","Healthy","Healthy","Experimental","Group A1|Group A2|Group A3|Group A4|Group A5|Group B","Dose 1 or placebo|Dose 2 or placebo|Dose 3 or placebo|Dose 4 or placebo|Dose 5 or placebo|Dose + Rosuvastatin","Drug","PXL770|Placebo|Rosuvastatin","MAD|DDI",null,"Group A1|Group A2|Group A3|Group A4|Group A5|Group B","\n\n * Male subjects deemed healthy on the basis of a clinical history, physical examination, ECG, vital signs, and laboratory tests of blood and urine\n * body mass index in the range 18.5-29.9 kg/mÂ²\n * body weight at least 60 kg\n * willing to use reliable contraception\n * able to give fully informed written consent.\n\n","\n\n * Pregnant or lactating woman, or sexually active woman of child-bearing potential not using reliable contraception\n * Clinically relevant abnormal findings at the screening assessment\n * Clinically significant vital signs outside the acceptable range at screening\n * Clinically relevant abnormal medical history, surgery or concurrent medical condition\n * Acute or chronic illness\n * Estimated glomerular filtration rate less than 80 mL/min/1.73 m2\n * Severe adverse reaction to any drug or sensitivity to the trial medication or its components\n * Significant food allergy; vegetarian or vegan\n * Participation in other clinical trials of unlicensed or prescription medicines, or loss of more than 400 mL blood, within the 3 months before first dose of trial medication\n * Drug or alcohol abuse\n * Smoking of more than 5 cigarettes daily\n * Possibility that subject will not cooperate\n * Positive test for hepatitis B & C, HIV\n * Objection by a General Practitioner",{"$nulls":4},"Actual","2018-01-10","Actual","Anticipated","2018-05-13","Anticipated","2018-01-01","2017-11-06","2018-01-09","2018-01-09",null,null,"Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years","55 Years","Male",null,"Yes",{"$nulls":4},"No","No",{"$nulls":19},"Part A: PK parameters of PXL770 after repeated doses Part B: PK parameters of rosuvastatin before and after repeated doses of PXl770|Part A: PK parameters of PXL770 after repeated doses","- Cmax: peak plasma concentration after dosing|- AUC0-t: area under the concentration-time curve from 0 extrapolated to time t|- AUC0-âˆž: area under the concentration-time curve from 0 extrapolated to infinite","From baseline to day 14","Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]","Incidence of treatment emergent adverse events","From baseline to day 14",{"$nulls":3},"London, United Kingdom",null,"United Kingdom","Hammersmith Medicines Research (Hmr)",{"$nulls":4},"2018-01-09","2020-05-25T16:36:08.972","2020-05-26T17:10:42.972","NCT03395470"]
["5ecbf3f811702c1b1b916a23","NCT03395470","2018-08-24","Poxel","PXXLF","Completed","Safety, Tolerability and PK of PXL770 in Healthy Male Subjects","Pxl-770|Rosuvastatin","AMPK Activator|HMG-CoA Inhibitor","Yes","['Pxl-770']","Yes","['AMPK Activator']","Phase 1",6,60,"Actual","2017-08-21","2018-03-16",{"$nulls":5},"PXL770 is a direct activator of 5' adenosine monophosphate-activated protein kinase (AMPK) being developed by Poxel S.A. for the treatment of type 2 diabetes mellitus (T2DM). In Part A of this study, we'll test the safety, tolerability and pharmacokinetics (PK) of repeated doses. In Part B, we'll co-administer PXL770 and rosuvastatin (a HMG-CoA reductase inhibitor) to assess any drug-drug interaction.",null,"A Double-blind, Randomised, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Doses of PXL770, Including an Open-label, One-sequence Part to Assess the Drug-drug Interaction With Rosuvastatin in Healthy Male Subjects","PXL770-002","Metabolic Disease","Healthy Volunteers","Healthy","Healthy","Experimental","Group A1|Group A2|Group A3|Group A4|Group A5|Group B","Dose 1 or placebo|Dose 2 or placebo|Dose 3 or placebo|Dose 4 or placebo|Dose 5 or placebo|Dose + Rosuvastatin","Drug","PXL770|Placebo|Rosuvastatin","MAD|DDI",null,"Group A1|Group A2|Group A3|Group A4|Group A5|Group B","\n\n * Male subjects deemed healthy on the basis of a clinical history, physical examination, ECG, vital signs, and laboratory tests of blood and urine\n * body mass index in the range 18.5-29.9 kg/mÂ²\n * body weight at least 60 kg\n * willing to use reliable contraception\n * able to give fully informed written consent.\n\n","\n\n * Pregnant or lactating woman, or sexually active woman of child-bearing potential not using reliable contraception\n * Clinically relevant abnormal findings at the screening assessment\n * Clinically significant vital signs outside the acceptable range at screening\n * Clinically relevant abnormal medical history, surgery or concurrent medical condition\n * Acute or chronic illness\n * Estimated glomerular filtration rate less than 80 mL/min/1.73 m2\n * Severe adverse reaction to any drug or sensitivity to the trial medication or its components\n * Significant food allergy; vegetarian or vegan\n * Participation in other clinical trials of unlicensed or prescription medicines, or loss of more than 400 mL blood, within the 3 months before first dose of trial medication\n * Drug or alcohol abuse\n * Smoking of more than 5 cigarettes daily\n * Possibility that subject will not cooperate\n * Positive test for hepatitis B & C, HIV\n * Objection by a General Practitioner",{"$nulls":4},"Actual","2018-01-10","Actual","Actual","2018-03-16","Actual","2018-08-01","2017-11-06","2018-01-09","2018-08-23",null,null,"Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years","55 Years","Male",null,"Yes",{"$nulls":4},"No","No",{"$nulls":19},"Part A: PK parameters of PXL770 after repeated doses Part B: PK parameters of rosuvastatin before and after repeated doses of PXl770|Part A: PK parameters of PXL770 after repeated doses","- Cmax: peak plasma concentration after dosing|- AUC0-t: area under the concentration-time curve from 0 extrapolated to time t|- AUC0-âˆž: area under the concentration-time curve from 0 extrapolated to infinite","From baseline to day 14","Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]","Incidence of treatment emergent adverse events","From baseline to day 14",{"$nulls":3},"London, United Kingdom",null,"United Kingdom","Hammersmith Medicines Research (Hmr)",{"$nulls":4},"2018-08-23","2020-05-25T16:36:08.765","2020-05-26T17:10:42.972","NCT03395470"]
["5ecbf3f911702c1b1b916a25","NCT03395639","2018-01-10","Daiichi Sankyo","DSNKY","Not yet recruiting","Edoxaban for Prevention of Blood Vessels Being Blocked by Clots (Thrombolytic Events) in Children at Risk Because of Cardiac Disease","Edoxaban|Enoxaparin sodium|Heparin|Warfarin","FXa Inhibitor|AT III Activator|Thrombin Inhibitor|Heparin Inhibitor|Vitamin K Antagonist","No",null,"No",null,"Phase 3",2,150,"Anticipated","2018-02-01","2021-03-01",{"$nulls":5},"A committee will judge the safety and effectiveness of edoxaban and the regular treatment (standard of care).\n\nAll children in the study will receive free treatment. They will have a 2 in 3 chance to receive edoxaban, and a 1 in 3 chance to receive the standard of care for preventing blood clots.\n\nThe study will find out if edoxaban is safer and more effective than the standard of care.","The primary objective is to compare the safety of edoxaban with the standard of care (SOC) in pediatric subjects with cardiac diseases at risk of thromboembolic complications who need primary or secondary anticoagulant prophylaxis with regard to the combination of major and clinically relevant non-major (CRNM) bleeding per International Society on Thrombosis and Haemostasis [ISTH] definition.\n\nThe key secondary objective is to compare the efficacy of edoxaban against SOC with regard to the development of symptomatic thromboembolic events (TE) in the systemic arterial or venous pathways including deep vein thrombosis (DVT), pulmonary embolism (PE), stroke, intracardiac thrombus and myocardial infarction (MI), and asymptomatic intracardiac thrombus identified by cardiac imaging.","An Open-label, Randomised, Parallel-group, Multicentre, Observational Trial to Evaluate Safety and Efficacy of Edoxaban Tosylate in Children From 38 Weeks Gestational Age to Less Than 18 Years of Age With Cardiac Diseases at Risk of Thromboembolic Events","DU176b-C-U313","Anticoagulant Drugs\nCardiac Disease","Myocardial Infarction|Embolism|Pulmonary Embolism|Thrombosis|Stroke|Embolism and Thrombosis|Venous Thrombosis|Pulmonary Infarction","Heart Diseases|Vascular Diseases|Lung Diseases|Central Nervous System Diseases","Cardiovascular|Respiratory|Central Nervous System","Experimental|Active Comparator","Edoxaban|Standard of Care (SOC)","Two out of three participants will be randomized for treatment with edoxaban solution or tablets|One out of three participants will be randomized for treatment with the institution's SOC regimen","Drug","Edoxaban|Standard of Care (SOC)","Edoxaban 15 mg or 30 mg tablets for participants 12 to <18 years of age, or 60 mg edoxaban suspension (dosed as mg/kg) for participants under 12 years of age (and optionally, 12 or older), for oral administration|Standard of care could include low molecular weight heparin (LMWH) and/or VKA according to the clinical site's SOC treatment regimen","Lixiana|Warfarin/heparin | Enoxaparin","Edoxaban|Standard of Care (SOC)","\n\n * Is a child with cardiac disease who is at risk for thromboembolic complications and requires at least 3 months antithrombotic anticoagulant prophylaxis\n\nEither one of the following:\n\n 1. a child with cardiac disease who has a history of cardiac shunt occlusion/thrombosis, with shunt still in place (secondary prevention).OR\n    \n    \n 2. a child with cardiac disease who requires (including those already taking, and those not yet taking) anticoagulation for primary prevention of TE.\n\nCardiac conditions known to significantly increase the risk of thrombosis (hence, indications for primary TE prevention) are defined in Antithrombotic Therapy and Prevention of Thrombosis. Some examples of cardiac conditions at risk of thrombosis are Fontan surgery, heart failure, Kawasaki disease, and Blalock-Taussig and Glenn surgery.\n\n * Is a male or female child between 1 and <18 years of age (children between 38 weeks gestational age and 1 year of age will be included in the study, however, only after the safety and efficacy data of 50 subjects between 1 and <18 years of age in the edoxaban arm have been evaluated at the end of the 3-month treatment period)\n * Has parent(s)/legal guardian(s) or legally acceptable representative who is informed and provides signed consent for the child, to participate in the study with edoxaban treatment. Pediatric participants with appropriate intellectual maturity will be required to sign an assent form in addition to the signed informed consent from the parent(s)/legal guardian(s) or any legally acceptable representative.\n * If a female subject of childbearing potential, tests negative for pregnancy at Screening and consents to avoid becoming pregnant by using a locally approved contraception method throughout the study\n\n","\n\n * Has evidence of symptomatic venous or arterial thrombosis and/or asymptomatic intracardiac thrombosis confirmed by a transthoracic echocardiogram during study screening period\n * Has mechanical heart valve(s)\n * Has active bleeding or high risk of bleeding contraindicating treatment with anticoagulant\n * Takes antithrombotic therapy (other than low-dose aspirin) that is not protocol-related\n * Has any hepatic disease associated with coagulopathy leading to a clinically relevant bleeding risk\n * Has estimated glomerular filtration rate (eGFR) <30% of normal for age and size\n * Has stage 2 hypertension defined as blood pressure systolic and/or diastolic confirmed >99th percentile plus 5 mmHg\n * Has thrombocytopenia or life expectancy less than three months\n * Has had Fontan procedure with a history of or signs/symptoms suggestive of protein-losing enteropathy\n * Is pregnant or breastfeeding\n * Has a contraindication to the use of heparin and/or vitamin K antagonist (VKA)\n * Has any condition that, as judged by the Investigator, would place the participant at increased risk of harm if he/she participated in the study",{"$nulls":4},"Actual","2018-01-10","Actual","Anticipated","2021-03-01","Anticipated","2018-01-01","2018-01-04","2018-01-04","2018-01-04","Yes","Children\nPediatrics\nCardiac disease with potential for thromboembolic complications\nProphylactic treatment","Interventional","Prevention","Parallel Assignment","None (Open Label)","Randomized",null,"17 Years","All",null,"No","Yes\nDe-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at http://www.clinicalstudydatarequest.com. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://www.clinicalstudydatarequest.com/Study-Sponsors-DS-Details.aspx",{"$nulls":3},"Yes","No",{"$nulls":17},"2017-000475-90","EudraCT Number","Number of participants with combined bleeding events within the main treatment period|Number of participants with combined bleeding events during the entire trial (from first to the last dose plus 30 days)","Combined bleeding events include major and clinically-relevant non-major (CRNM) bleeding events per International Society on Thrombosis and Haemostasis (ISTH) definition occurring within the main treatment period|Combined bleeding events include major and clinically-relevant non-major (CRNM) bleeding events per International Society on Thrombosis and Haemostasis (ISTH) definition occurring on treatment","within 4 months (3-month Main Treatment Period + 30-day follow-up)|within 13 months (3-month Main Treatment Period + 9-month Extension Period + 30-day follow-up)","Number of participants with symptomatic thromboembolic events (TE) in the systemic arterial or venous pathways|Number of participants who died as a result of TE between randomization and the date of the last dose of study drug plus 30 days|Number of participants who died as a result of any cause between randomization and the date of the last dose of study drug plus 30 days","Symptomatic thromboembolic events (TE) in the systemic arterial or venous pathways include deep vein thrombosis (DVT), pulmonary embolism (PE), stroke, intracardiac thrombus and myocardial infarction (MI)|within 13 months","within 4 months|within 13 months",{"$nulls":10},"Clinical Study Leader","2018-01-04","2020-05-25T16:36:09.742","2020-05-26T17:10:42.972","NCT03395639"]
["5ecbf3f9307e3d1b1f8d9ca5","NCT03395639","2018-01-23","Daiichi Sankyo","DSNKY","Not yet recruiting","Edoxaban for Prevention of Blood Vessels Being Blocked by Clots (Thrombolytic Events) in Children at Risk Because of Cardiac Disease","Edoxaban|Enoxaparin sodium|Heparin|Warfarin","FXa Inhibitor|AT III Activator|Thrombin Inhibitor|Heparin Inhibitor|Vitamin K Antagonist","No",null,"No",null,"Phase 3",2,150,"Anticipated","2018-02-01","2021-03-01",{"$nulls":5},"A committee will judge the safety and effectiveness of edoxaban and the regular treatment (standard of care).\n\nAll children in the study will receive free treatment. They will have a 2 in 3 chance to receive edoxaban, and a 1 in 3 chance to receive the standard of care for preventing blood clots.\n\nThe study will find out if edoxaban is safer and more effective than the standard of care.","The primary objective is to compare the safety of edoxaban with the standard of care (SOC) in pediatric subjects with cardiac diseases at risk of thromboembolic complications who need primary or secondary anticoagulant prophylaxis with regard to the combination of major and clinically relevant non-major (CRNM) bleeding per International Society on Thrombosis and Haemostasis [ISTH] definition.\n\nThe key secondary objective is to compare the efficacy of edoxaban against SOC with regard to the development of symptomatic thromboembolic events (TE) in the systemic arterial or venous pathways including deep vein thrombosis (DVT), pulmonary embolism (PE), stroke, intracardiac thrombus and myocardial infarction (MI), and asymptomatic intracardiac thrombus identified by cardiac imaging.","An Open-label, Randomised, Parallel-group, Multicentre, Observational Trial to Evaluate Safety and Efficacy of Edoxaban Tosylate in Children From 38 Weeks Gestational Age to Less Than 18 Years of Age With Cardiac Diseases at Risk of Thromboembolic Events","DU176b-C-U313","Anticoagulant Drugs\nCardiac Disease","Myocardial Infarction|Embolism|Pulmonary Embolism|Thrombosis|Stroke|Embolism and Thrombosis|Venous Thrombosis|Pulmonary Infarction","Heart Diseases|Vascular Diseases|Lung Diseases|Central Nervous System Diseases","Cardiovascular|Respiratory|Central Nervous System","Experimental|Active Comparator","Edoxaban|Standard of Care (SOC)","Two out of three participants will be randomized for treatment with edoxaban solution or tablets|One out of three participants will be randomized for treatment with the institution's SOC regimen","Drug","Edoxaban|Standard of Care (SOC)","Edoxaban 15 mg or 30 mg tablets for participants 12 to <18 years of age, or 60 mg edoxaban suspension (dosed as mg/kg) for participants under 12 years of age (and optionally, 12 or older), for oral administration|Standard of care could include low molecular weight heparin (LMWH) and/or VKA according to the clinical site's SOC treatment regimen","Lixiana|Warfarin/heparin | Enoxaparin","Edoxaban|Standard of Care (SOC)","\n\n * Is a child with cardiac disease who is at risk for thromboembolic complications and requires at least 3 months antithrombotic anticoagulant prophylaxis\n\nEither one of the following:\n\n 1. a child with cardiac disease who has a history of cardiac shunt occlusion/thrombosis, with shunt still in place (secondary prevention).OR\n    \n    \n 2. a child with cardiac disease who requires (including those already taking, and those not yet taking) anticoagulation for primary prevention of TE.\n\nCardiac conditions known to significantly increase the risk of thrombosis (hence, indications for primary TE prevention) are defined in Antithrombotic Therapy and Prevention of Thrombosis. Some examples of cardiac conditions at risk of thrombosis are Fontan surgery, heart failure, Kawasaki disease, and Blalock-Taussig and Glenn surgery.\n\n * Is a male or female child between 1 and <18 years of age (children between 38 weeks gestational age and 1 year of age will be included in the study, however, only after the safety and efficacy data of 50 subjects between 1 and <18 years of age in the edoxaban arm have been evaluated at the end of the 3-month treatment period)\n * Has parent(s)/legal guardian(s) or legally acceptable representative who is informed and provides signed consent for the child, to participate in the study with edoxaban treatment. Pediatric participants with appropriate intellectual maturity will be required to sign an assent form in addition to the signed informed consent from the parent(s)/legal guardian(s) or any legally acceptable representative.\n * If a female subject of childbearing potential, tests negative for pregnancy at Screening and consents to avoid becoming pregnant by using a locally approved contraception method throughout the study\n\n","\n\n * Has evidence of symptomatic venous or arterial thrombosis and/or asymptomatic intracardiac thrombosis confirmed by a transthoracic echocardiogram during study screening period\n * Has mechanical heart valve(s)\n * Has active bleeding or high risk of bleeding contraindicating treatment with anticoagulant\n * Takes antithrombotic therapy (other than low-dose aspirin) that is not protocol-related\n * Has any hepatic disease associated with coagulopathy leading to a clinically relevant bleeding risk\n * Has estimated glomerular filtration rate (eGFR) <30% of normal for age and size\n * Has stage 2 hypertension defined as blood pressure systolic and/or diastolic confirmed >99th percentile plus 5 mmHg\n * Has thrombocytopenia or life expectancy less than three months\n * Has had Fontan procedure with a history of or signs/symptoms suggestive of protein-losing enteropathy\n * Is pregnant or breastfeeding\n * Has a contraindication to the use of heparin and/or vitamin K antagonist (VKA)\n * Has any condition that, as judged by the Investigator, would place the participant at increased risk of harm if he/she participated in the study",{"$nulls":4},"Actual","2018-01-10","Actual","Anticipated","2021-03-01","Anticipated","2018-01-01","2018-01-04","2018-01-04","2018-01-19","Yes","Children\nPediatrics\nCardiac disease with potential for thromboembolic complications\nProphylactic treatment","Interventional","Prevention","Parallel Assignment","None (Open Label)","Randomized",null,"17 Years","All",null,"No","Yes\nDe-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at http://www.clinicalstudydatarequest.com. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://www.clinicalstudydatarequest.com/Study-Sponsors-DS-Details.aspx",{"$nulls":3},"Yes","No",{"$nulls":17},"2017-000475-90","EudraCT Number","Number of participants with combined bleeding events within the main treatment period|Number of participants with combined bleeding events during the entire trial (from first to the last dose plus 30 days)","Combined bleeding events include major and clinically-relevant non-major (CRNM) bleeding events per International Society on Thrombosis and Haemostasis (ISTH) definition occurring within the main treatment period|Combined bleeding events include major and clinically-relevant non-major (CRNM) bleeding events per International Society on Thrombosis and Haemostasis (ISTH) definition occurring on treatment","within 4 months (3-month Main Treatment Period + 30-day follow-up)|within 13 months (3-month Main Treatment Period + 9-month Extension Period + 30-day follow-up)","Number of participants with symptomatic thromboembolic events (TE) in the systemic arterial or venous pathways|Number of participants who died as a result of TE between randomization and the date of the last dose of study drug plus 30 days|Number of participants who died as a result of any cause between randomization and the date of the last dose of study drug plus 30 days","Symptomatic thromboembolic events (TE) in the systemic arterial or venous pathways include deep vein thrombosis (DVT), pulmonary embolism (PE), stroke, intracardiac thrombus and myocardial infarction (MI)|within 13 months","within 4 months|within 13 months",{"$nulls":3},"Linz, Austria, 4020|Hamilton, Canada, L8N 3Z5|Zadar, Croatia, 23000|Alexandria, Egypt, 21131|Beirut, Lebanon, 166830|Montpellier Cedex 5, France, 34295|Berlin, Germany, 13353|Budapest, Hungary, 1037|New Delhi, India, 110060|Beer Sheva, Israel, 8410101|Genova, Italy, 16147|Beirut, Lebanon, 1107 2020|Warszaw, Poland, 04-730|Barcelona, Spain, 08035|Adana, Turkey, 01330|Dnipro, Ukraine, 49100|Poltava, Ukraine, 36004|Glasgow, United Kingdom, G51 4Tf|Birmingham, Alabama, United States, 35233|Mesa, Arizona, United States, 85202|Los Angeles, California, United States, 90048|Gainesville, Florida, United States, 32610|Chicago, Illinois, United States, 60611|Lexington, Kentucky, United States, 40506|Saint Louis, Missouri, United States, 63110|New York, New York, United States, 10029|Charlotte, North Carolina, United States, 28204|Oklahoma City, Oklahoma, United States, 73104|Charlottesville, Virginia, United States, 22903|Seattle, Washington, United States, 98105","Alabama|Arizona|California|Florida|Illinois|Kentucky|Missouri|New York|North Carolina|Oklahoma|Virginia|Washington","Austria|Canada|Croatia|Egypt|France|Germany|Hungary|India|Israel|Italy|Lebanon|Poland|Spain|Turkey|Ukraine|United Kingdom|United States","Kepler UniversitÃ¤tsklinikum Med Campus Iv|Mcmaster Children's Hospital|General Hospital Zadar|Alexandria University Hospital|Hospital|HÃ´pital Arnaud De Villeneuve|Charite - Campus Virchow-Klinikum|Svabhegy Plusz Gyermek-Egeszsegugyi Kozpont Kft.|Sir Ganga Ram Hospital|Soroka University Medical Center|Istituto Giannina Gaslini-Ospedale Pediatrico Irccs|American University Of Beirut Medical Center|Instytut \"Pomnik - Centrum Zdrowia Dziecka\"|Hospital Universitari Vall D'Hebron|Cukurova University Medical Faculty|Ci Dnipropetrovsk Rcch Of Dnipropetrovsk Rc Dept Of Surgery Si Dnipropetrovsk Ma Of The Mohu|Umsa|Royal Hospital For Sick Children Yorkhill|University Of Alabama At Birmingham|Cardon Childrens Medical Center|Cedars Sinai Medical Center (Ecg)|University Of Florida College Of Medicine|Ann & Robert H. Lurie Children's Hospital Of Chicago|University Of Kentucky Ped Car|Washington University|Icahn School Of Medicine At Mount Sinai|Novant Health Heart And Vascular Institute|Ou Health Sciences Center|University Of Virginia Health System|Seattle Children's Hospital",{"$nulls":3},"Clinical Study Leader","2018-01-19","2020-05-25T16:36:09.977","2020-05-26T17:10:42.972","NCT03395639"]
["5ecbf3fae2561b1b11905d11","NCT03395639","2018-01-29","Daiichi Sankyo","DSNKY","Not yet recruiting","Edoxaban for Prevention of Blood Vessels Being Blocked by Clots (Thrombolytic Events) in Children at Risk Because of Cardiac Disease","Edoxaban|Enoxaparin sodium|Heparin|Warfarin","FXa Inhibitor|AT III Activator|Thrombin Inhibitor|Heparin Inhibitor|Vitamin K Antagonist","No",null,"No",null,"Phase 3",2,150,"Anticipated","2018-02-01","2021-03-01",{"$nulls":5},"A committee will judge the safety and effectiveness of edoxaban and the regular treatment (standard of care).\n\nAll children in the study will receive free treatment. They will have a 2 in 3 chance to receive edoxaban, and a 1 in 3 chance to receive the standard of care for preventing blood clots.\n\nThe study will find out if edoxaban is safer and more effective than the standard of care.","The primary objective is to compare the safety of edoxaban with the standard of care (SOC) in pediatric subjects with cardiac diseases at risk of thromboembolic complications who need primary or secondary anticoagulant prophylaxis with regard to the combination of major and clinically relevant non-major (CRNM) bleeding per International Society on Thrombosis and Haemostasis [ISTH] definition.\n\nThe key secondary objective is to compare the efficacy of edoxaban against SOC with regard to the development of symptomatic thromboembolic events (TE) in the systemic arterial or venous pathways including deep vein thrombosis (DVT), pulmonary embolism (PE), stroke, intracardiac thrombus and myocardial infarction (MI), and asymptomatic intracardiac thrombus identified by cardiac imaging.","An Open-label, Randomised, Parallel-group, Multicentre, Observational Trial to Evaluate Safety and Efficacy of Edoxaban Tosylate in Children From 38 Weeks Gestational Age to Less Than 18 Years of Age With Cardiac Diseases at Risk of Thromboembolic Events","DU176b-C-U313","Anticoagulant Drugs\nCardiac Disease","Myocardial Infarction|Embolism|Pulmonary Embolism|Thrombosis|Stroke|Embolism and Thrombosis|Venous Thrombosis|Pulmonary Infarction","Heart Diseases|Vascular Diseases|Lung Diseases|Central Nervous System Diseases","Cardiovascular|Respiratory|Central Nervous System","Experimental|Active Comparator","Edoxaban|Standard of Care (SOC)","Two out of three participants will be randomized for treatment with edoxaban solution or tablets|One out of three participants will be randomized for treatment with the institution's SOC regimen","Drug","Edoxaban|Standard of Care (SOC)","Edoxaban 15 mg or 30 mg tablets for participants 12 to <18 years of age, or 60 mg edoxaban suspension (dosed as mg/kg) for participants under 12 years of age (and optionally, 12 or older), for oral administration|Standard of care could include low molecular weight heparin (LMWH) and/or VKA according to the clinical site's SOC treatment regimen","Lixiana|Warfarin/heparin | Enoxaparin","Edoxaban|Standard of Care (SOC)","\n\n * Is a child with cardiac disease who is at risk for thromboembolic complications and requires at least 3 months antithrombotic anticoagulant prophylaxis\n\nEither one of the following:\n\n 1. a child with cardiac disease who has a history of cardiac shunt occlusion/thrombosis, with shunt still in place (secondary prevention).OR\n    \n    \n 2. a child with cardiac disease who requires (including those already taking, and those not yet taking) anticoagulation for primary prevention of TE.\n\nCardiac conditions known to significantly increase the risk of thrombosis (hence, indications for primary TE prevention) are defined in Antithrombotic Therapy and Prevention of Thrombosis. Some examples of cardiac conditions at risk of thrombosis are Fontan surgery, heart failure, Kawasaki disease, and Blalock-Taussig and Glenn surgery.\n\n * Is a male or female child between 1 and <18 years of age (children between 38 weeks gestational age and 1 year of age will be included in the study, however, only after the safety and efficacy data of 50 subjects between 1 and <18 years of age in the edoxaban arm have been evaluated at the end of the 3-month treatment period)\n * Has parent(s)/legal guardian(s) or legally acceptable representative who is informed and provides signed consent for the child, to participate in the study with edoxaban treatment. Pediatric participants with appropriate intellectual maturity will be required to sign an assent form in addition to the signed informed consent from the parent(s)/legal guardian(s) or any legally acceptable representative.\n * If a female subject of childbearing potential, tests negative for pregnancy at Screening and consents to avoid becoming pregnant by using a locally approved contraception method throughout the study\n\n","\n\n * Has evidence of symptomatic venous or arterial thrombosis and/or asymptomatic intracardiac thrombosis confirmed by a transthoracic echocardiogram during study screening period\n * Has mechanical heart valve(s)\n * Has active bleeding or high risk of bleeding contraindicating treatment with anticoagulant\n * Takes antithrombotic therapy (other than low-dose aspirin) that is not protocol-related\n * Administration of rifampin is prohibited during the study and subjects on concomitant use of rifampin are excluded\n * Has any hepatic disease associated with coagulopathy leading to a clinically relevant bleeding risk\n * Has estimated glomerular filtration rate (eGFR) <30% of normal for age and size\n * Has stage 2 hypertension defined as blood pressure systolic and/or diastolic confirmed >99th percentile plus 5 mmHg\n * Has thrombocytopenia or life expectancy less than three months\n * Has had Fontan procedure with a history of or signs/symptoms suggestive of protein-losing enteropathy\n * Is pregnant or breastfeeding\n * Has a contraindication to the use of heparin and/or vitamin K antagonist (VKA)\n * Has any condition that, as judged by the Investigator, would place the participant at increased risk of harm if he/she participated in the study, including contraindicated medications identified in the protocol",{"$nulls":4},"Actual","2018-01-10","Actual","Anticipated","2021-03-01","Anticipated","2018-01-01","2018-01-04","2018-01-04","2018-01-25","Yes","Children\nPediatrics\nCardiac disease with potential for thromboembolic complications\nProphylactic treatment","Interventional","Prevention","Parallel Assignment","None (Open Label)","Randomized",null,"17 Years","All",null,"No","Yes\nDe-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at http://www.clinicalstudydatarequest.com. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://www.clinicalstudydatarequest.com/Study-Sponsors-DS-Details.aspx",{"$nulls":3},"Yes","No",{"$nulls":17},"2017-000475-90","EudraCT Number","Number of participants with combined bleeding events within the main treatment period|Number of participants with combined bleeding events during the entire trial (from first to the last dose plus 30 days)","Combined bleeding events include major and clinically-relevant non-major (CRNM) bleeding events per International Society on Thrombosis and Haemostasis (ISTH) definition occurring within the main treatment period|Combined bleeding events include major and clinically-relevant non-major (CRNM) bleeding events per International Society on Thrombosis and Haemostasis (ISTH) definition occurring on treatment","within 4 months (3-month Main Treatment Period + 30-day follow-up)|within 13 months (3-month Main Treatment Period + 9-month Extension Period + 30-day follow-up)","Number of participants with symptomatic thromboembolic events (TE) in the systemic arterial or venous pathways|Number of participants who died as a result of TE between randomization and the date of the last dose of study drug plus 30 days|Number of participants who died as a result of any cause between randomization and the date of the last dose of study drug plus 30 days","Symptomatic thromboembolic events (TE) in the systemic arterial or venous pathways include deep vein thrombosis (DVT), pulmonary embolism (PE), stroke, intracardiac thrombus and myocardial infarction (MI)|within 13 months","within 4 months|within 13 months",{"$nulls":3},"Linz, Austria, 4020|Hamilton, Canada, L8N 3Z5|Zadar, Croatia, 23000|Alexandria, Egypt, 21131|Beirut, Lebanon, 166830|Montpellier Cedex 5, France, 34295|Berlin, Germany, 13353|Budapest, Hungary, 1037|New Delhi, India, 110060|Beer Sheva, Israel, 8410101|Genova, Italy, 16147|Beirut, Lebanon, 1107 2020|Warszaw, Poland, 04-730|Barcelona, Spain, 08035|Adana, Turkey, 01330|Dnipro, Ukraine, 49100|Poltava, Ukraine, 36004|Glasgow, United Kingdom, G51 4Tf|Birmingham, Alabama, United States, 35233|Mesa, Arizona, United States, 85202|Los Angeles, California, United States, 90048|Gainesville, Florida, United States, 32610|Chicago, Illinois, United States, 60611|Lexington, Kentucky, United States, 40506|Saint Louis, Missouri, United States, 63110|New York, New York, United States, 10029|Charlotte, North Carolina, United States, 28204|Oklahoma City, Oklahoma, United States, 73104|Charlottesville, Virginia, United States, 22903|Seattle, Washington, United States, 98105","Alabama|Arizona|California|Florida|Illinois|Kentucky|Missouri|New York|North Carolina|Oklahoma|Virginia|Washington","Austria|Canada|Croatia|Egypt|France|Germany|Hungary|India|Israel|Italy|Lebanon|Poland|Spain|Turkey|Ukraine|United Kingdom|United States","Kepler UniversitÃ¤tsklinikum Med Campus Iv|Mcmaster Children's Hospital|General Hospital Zadar|Alexandria University Hospital|Hospital|HÃ´pital Arnaud De Villeneuve|Charite - Campus Virchow-Klinikum|Svabhegy Plusz Gyermek-Egeszsegugyi Kozpont Kft.|Sir Ganga Ram Hospital|Soroka University Medical Center|Istituto Giannina Gaslini-Ospedale Pediatrico Irccs|American University Of Beirut Medical Center|Instytut \"Pomnik - Centrum Zdrowia Dziecka\"|Hospital Universitari Vall D'Hebron|Cukurova University Medical Faculty|Ci Dnipropetrovsk Rcch Of Dnipropetrovsk Rc Dept Of Surgery Si Dnipropetrovsk Ma Of The Mohu|Umsa|Royal Hospital For Sick Children Yorkhill|University Of Alabama At Birmingham|Cardon Childrens Medical Center|Cedars Sinai Medical Center (Ecg)|University Of Florida College Of Medicine|Ann & Robert H. Lurie Children's Hospital Of Chicago|University Of Kentucky Ped Car|Washington University|Icahn School Of Medicine At Mount Sinai|Novant Health Heart And Vascular Institute|Ou Health Sciences Center|University Of Virginia Health System|Seattle Children's Hospital",{"$nulls":3},"Clinical Study Leader","2018-01-25","2020-05-25T16:36:10.468","2020-05-26T17:10:42.972","NCT03395639"]
["5ecbf3fae2561b1b11905d10","NCT03395639","2018-03-29","Daiichi Sankyo","DSNKY","Recruiting","Edoxaban for Prevention of Blood Vessels Being Blocked by Clots (Thrombotic Events) in Children at Risk Because of Cardiac Disease","Edoxaban|Enoxaparin sodium|Heparin|Warfarin","FXa Inhibitor|AT III Activator|Thrombin Inhibitor|Heparin Inhibitor|Vitamin K Antagonist","No",null,"No",null,"Phase 3",2,150,"Anticipated","2017-11-17","2021-03-01",{"$nulls":5},"A committee will judge the safety and effectiveness of edoxaban and the regular treatment (standard of care).\n\nAll children in the study will receive free treatment. They will have a 2 in 3 chance to receive edoxaban, and a 1 in 3 chance to receive the standard of care for preventing blood clots.\n\nThe study will find out if edoxaban is safer and more effective than the standard of care.","The primary objective is to compare the safety of edoxaban with the standard of care (SOC) in pediatric subjects with cardiac diseases at risk of thromboembolic complications who need primary or secondary anticoagulant prophylaxis with regard to the combination of major and clinically relevant non-major (CRNM) bleeding per International Society on Thrombosis and Haemostasis [ISTH] definition.\n\nThe key secondary objective is to compare the efficacy of edoxaban against SOC with regard to the development of symptomatic thromboembolic events (TE) in the systemic arterial or venous pathways including deep vein thrombosis (DVT), pulmonary embolism (PE), stroke, intracardiac thrombus and myocardial infarction (MI), and asymptomatic intracardiac thrombus identified by cardiac imaging.","An Open-label, Randomised, Parallel-group, Multicentre, Observational Trial to Evaluate Safety and Efficacy of Edoxaban Tosylate in Children From 38 Weeks Gestational Age to Less Than 18 Years of Age With Cardiac Diseases at Risk of Thromboembolic Events","DU176b-C-U313","Anticoagulant Drugs\nCardiac Disease","Myocardial Infarction|Embolism|Pulmonary Embolism|Thrombosis|Stroke|Embolism and Thrombosis|Venous Thrombosis|Pulmonary Infarction","Heart Diseases|Vascular Diseases|Lung Diseases|Central Nervous System Diseases","Cardiovascular|Respiratory|Central Nervous System","Experimental|Active Comparator","Edoxaban|Standard of Care (SOC)","Two out of three participants will be randomized for treatment with edoxaban solution or tablets|One out of three participants will be randomized for treatment with the institution's SOC regimen","Drug","Edoxaban|Standard of Care (SOC)","Edoxaban 15 mg or 30 mg tablets for participants 12 to <18 years of age, or 60 mg edoxaban suspension (dosed as mg/kg) for participants under 12 years of age (and optionally, 12 or older), for oral administration|Standard of care could include low molecular weight heparin (LMWH) and/or VKA according to the clinical site's SOC treatment regimen","Lixiana | Savaysa|Warfarin/heparin | Enoxaparin","Edoxaban|Standard of Care (SOC)","\n\n * Is a child with cardiac disease who is at risk for thromboembolic complications and requires at least 3 months antithrombotic anticoagulant prophylaxis\n\nEither one of the following:\n\n 1. a child with cardiac disease who has a history of cardiac shunt occlusion/thrombosis, with shunt still in place (secondary prevention).OR\n    \n    \n 2. a child with cardiac disease who requires (including those already taking, and those not yet taking) anticoagulation for primary prevention of TE.\n\nCardiac conditions known to significantly increase the risk of thrombosis (hence, indications for primary TE prevention) are defined in Antithrombotic Therapy and Prevention of Thrombosis. Some examples of cardiac conditions at risk of thrombosis are Fontan surgery, heart failure, Kawasaki disease, and Blalock-Taussig and Glenn surgery.\n\n * Is a male or female child between 1 and <18 years of age (children between 38 weeks gestational age and 1 year of age will be included in the study, however, only after the safety and efficacy data of 50 subjects between 1 and <18 years of age in the edoxaban arm have been evaluated at the end of the 3-month treatment period)\n * Has parent(s)/legal guardian(s) or legally acceptable representative who is informed and provides signed consent for the child, to participate in the study with edoxaban treatment. Pediatric participants with appropriate intellectual maturity will be required to sign an assent form in addition to the signed informed consent from the parent(s)/legal guardian(s) or any legally acceptable representative.\n * If a female subject of childbearing potential, tests negative for pregnancy at Screening and consents to avoid becoming pregnant by using a locally approved contraception method throughout the study\n\n","\n\n * Has evidence of symptomatic venous or arterial thrombosis and/or asymptomatic intracardiac thrombosis confirmed by a transthoracic echocardiogram during study screening period\n * Has mechanical heart valve(s)\n * Has active bleeding or high risk of bleeding contraindicating treatment with anticoagulant\n * Takes antithrombotic therapy (other than low-dose aspirin) that is not protocol-related\n * Administration of rifampin is prohibited during the study and subjects on concomitant use of rifampin are excluded\n * Has any hepatic disease associated with coagulopathy leading to a clinically relevant bleeding risk\n * Has estimated glomerular filtration rate (eGFR) <30% of normal for age and size\n * Has stage 2 hypertension defined as blood pressure systolic and/or diastolic confirmed >99th percentile plus 5 mmHg\n * Has thrombocytopenia or life expectancy less than three months\n * Has had Fontan procedure with a history of or signs/symptoms suggestive of protein-losing enteropathy\n * Is pregnant or breastfeeding\n * Has a contraindication to the use of heparin and/or vitamin K antagonist (VKA)\n * Has any condition that, as judged by the Investigator, would place the participant at increased risk of harm if he/she participated in the study, including contraindicated medications identified in the protocol",{"$nulls":4},"Actual","2018-01-10","Actual","Anticipated","2021-03-01","Anticipated","2018-03-01","2018-01-04","2018-01-04","2018-03-26","Yes","Children\nPediatrics\nCardiac disease with potential for thromboembolic complications\nProphylactic treatment","Interventional","Prevention","Parallel Assignment","None (Open Label)","Randomized",null,"17 Years","All",null,"No","Yes\nDe-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at http://www.clinicalstudydatarequest.com. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://www.clinicalstudydatarequest.com/Study-Sponsors-DS-Details.aspx",{"$nulls":3},"Yes","No",{"$nulls":17},"2017-000475-90","EudraCT Number","Number of participants with combined bleeding events within the main treatment period|Number of participants with combined bleeding events during the entire trial (from first to the last dose plus 30 days)","Combined bleeding events include major and clinically-relevant non-major (CRNM) bleeding events per International Society on Thrombosis and Haemostasis (ISTH) definition occurring within the main treatment period|Combined bleeding events include major and clinically-relevant non-major (CRNM) bleeding events per International Society on Thrombosis and Haemostasis (ISTH) definition occurring on treatment","within 4 months (3-month Main Treatment Period + 30-day follow-up)|within 13 months (3-month Main Treatment Period + 9-month Extension Period + 30-day follow-up)","Number of participants with symptomatic thromboembolic events (TE) in the systemic arterial or venous pathways|Number of participants who died as a result of TE between randomization and the date of the last dose of study drug plus 30 days|Number of participants who died as a result of any cause between randomization and the date of the last dose of study drug plus 30 days","Symptomatic thromboembolic events (TE) in the systemic arterial or venous pathways include deep vein thrombosis (DVT), pulmonary embolism (PE), stroke, intracardiac thrombus and myocardial infarction (MI)|within 13 months","within 4 months|within 13 months",{"$nulls":3},"Linz, Austria, 4020|Hamilton, Canada, L8N 3Z5|Zadar, Croatia, 23000|Alexandria, Egypt, 21131|Beirut, Lebanon, 166830|Montpellier Cedex 5, France, 34295|Berlin, Germany, 13353|Budapest, Hungary, 1037|New Delhi, India, 110060|Beer Sheva, Israel, 8410101|Genova, Italy, 16147|Beirut, Lebanon, 1107 2020|Warszaw, Poland, 04-730|Barcelona, Spain, 08035|Adana, Turkey, 01330|Dnipro, Ukraine, 49100|Poltava, Ukraine, 36004|Glasgow, United Kingdom, G51 4Tf|Birmingham, Alabama, United States, 35233|Mesa, Arizona, United States, 85202|Los Angeles, California, United States, 90048|Gainesville, Florida, United States, 32610|Chicago, Illinois, United States, 60611|Lexington, Kentucky, United States, 40506|Saint Louis, Missouri, United States, 63110|New York, New York, United States, 10029|Charlotte, North Carolina, United States, 28204|Oklahoma City, Oklahoma, United States, 73104|Charlottesville, Virginia, United States, 22903|Seattle, Washington, United States, 98105","Alabama|Arizona|California|Florida|Illinois|Kentucky|Missouri|New York|North Carolina|Oklahoma|Virginia|Washington","Austria|Canada|Croatia|Egypt|France|Germany|Hungary|India|Israel|Italy|Lebanon|Poland|Spain|Turkey|Ukraine|United Kingdom|United States","Kepler UniversitÃ¤tsklinikum Med Campus Iv|Mcmaster Children's Hospital|General Hospital Zadar|Alexandria University Hospital|Hospital|HÃ´pital Arnaud De Villeneuve|Charite - Campus Virchow-Klinikum|Svabhegy Plusz Gyermek-Egeszsegugyi Kozpont Kft.|Sir Ganga Ram Hospital|Soroka University Medical Center|Istituto Giannina Gaslini-Ospedale Pediatrico Irccs|American University Of Beirut Medical Center|Instytut \"Pomnik - Centrum Zdrowia Dziecka\"|Hospital Universitari Vall D'Hebron|Cukurova University Medical Faculty|Ci Dnipropetrovsk Rcch Of Dnipropetrovsk Rc Dept Of Surgery Si Dnipropetrovsk Ma Of The Mohu|Umsa|Royal Hospital For Sick Children Yorkhill|University Of Alabama At Birmingham|Cardon Childrens Medical Center|Cedars Sinai Medical Center (Ecg)|University Of Florida College Of Medicine|Ann & Robert H. Lurie Children's Hospital Of Chicago|University Of Kentucky Ped Car|Washington University|Icahn School Of Medicine At Mount Sinai|Novant Health Heart And Vascular Institute|Ou Health Sciences Center|University Of Virginia Health System|Seattle Children's Hospital",{"$nulls":3},"Clinical Study Leader","2018-03-26","2020-05-25T16:36:10.012","2020-05-26T17:10:42.972","NCT03395639"]
["5ecbf3fafeab101b15530845","NCT03395639","2018-04-23","Daiichi Sankyo","DSNKY","Recruiting","Edoxaban for Prevention of Blood Vessels Being Blocked by Clots (Thrombotic Events) in Children at Risk Because of Cardiac Disease","Edoxaban|Enoxaparin sodium|Heparin|Warfarin","FXa Inhibitor|AT III Activator|Thrombin Inhibitor|Heparin Inhibitor|Vitamin K Antagonist","No",null,"No",null,"Phase 3",2,150,"Anticipated","2017-11-17","2021-03-01",{"$nulls":5},"A committee will judge the safety and effectiveness of edoxaban and the regular treatment (standard of care).\n\nAll children in the study will receive free treatment. They will have a 2 in 3 chance to receive edoxaban, and a 1 in 3 chance to receive the standard of care for preventing blood clots.\n\nThe study will find out if edoxaban is safer and more effective than the standard of care.","The primary objective is to compare the safety of edoxaban with the standard of care (SOC) in pediatric subjects with cardiac diseases at risk of thromboembolic complications who need primary or secondary anticoagulant prophylaxis with regard to the combination of major and clinically relevant non-major (CRNM) bleeding per International Society on Thrombosis and Haemostasis [ISTH] definition.\n\nThe key secondary objective is to compare the efficacy of edoxaban against SOC with regard to the development of symptomatic thromboembolic events (TE) in the systemic arterial or venous pathways including deep vein thrombosis (DVT), pulmonary embolism (PE), stroke, intracardiac thrombus and myocardial infarction (MI), and asymptomatic intracardiac thrombus identified by cardiac imaging.","An Open-label, Randomised, Parallel-group, Multicentre, Observational Trial to Evaluate Safety and Efficacy of Edoxaban Tosylate in Children From 38 Weeks Gestational Age to Less Than 18 Years of Age With Cardiac Diseases at Risk of Thromboembolic Events","DU176b-C-U313","Cardiac Disease","Myocardial Infarction|Embolism|Pulmonary Embolism|Thrombosis|Stroke|Embolism and Thrombosis|Venous Thrombosis|Pulmonary Infarction","Heart Diseases|Vascular Diseases|Lung Diseases|Central Nervous System Diseases","Cardiovascular|Respiratory|Central Nervous System","Experimental|Active Comparator","Edoxaban|Standard of Care (SOC)","Two out of three participants will be randomized for treatment with edoxaban solution or tablets|One out of three participants will be randomized for treatment with the institution's SOC regimen","Drug","Edoxaban|Standard of Care (SOC)","Edoxaban 15 mg or 30 mg tablets for participants 12 to <18 years of age, or 60 mg edoxaban suspension (dosed as mg/kg) for participants under 12 years of age (and optionally, 12 or older), for oral administration|Standard of care could include low molecular weight heparin (LMWH) and/or VKA according to the clinical site's SOC treatment regimen","Lixiana | Savaysa|Warfarin/heparin | Enoxaparin","Edoxaban|Standard of Care (SOC)","\n\n * Is a child with cardiac disease who is at risk for thromboembolic complications and requires at least 3 months antithrombotic anticoagulant prophylaxis\n\nEither one of the following:\n\n 1. a child with cardiac disease who has a history of cardiac shunt occlusion/thrombosis, with shunt still in place (secondary prevention).OR\n    \n    \n 2. a child with cardiac disease who requires (including those already taking, and those not yet taking) anticoagulation for primary prevention of TE.\n\nCardiac conditions known to significantly increase the risk of thrombosis (hence, indications for primary TE prevention) are defined in Antithrombotic Therapy and Prevention of Thrombosis. Some examples of cardiac conditions at risk of thrombosis are Fontan surgery, heart failure, Kawasaki disease, and Blalock-Taussig and Glenn surgery.\n\n * Is a male or female child between 1 and <18 years of age (children between 38 weeks gestational age and 1 year of age will be included in the study, however, only after the safety and efficacy data of 50 subjects between 1 and <18 years of age in the edoxaban arm have been evaluated at the end of the 3-month treatment period)\n * Has parent(s)/legal guardian(s) or legally acceptable representative who is informed and provides signed consent for the child, to participate in the study with edoxaban treatment. Pediatric participants with appropriate intellectual maturity will be required to sign an assent form in addition to the signed informed consent from the parent(s)/legal guardian(s) or any legally acceptable representative.\n * If a female subject of childbearing potential, tests negative for pregnancy at Screening and consents to avoid becoming pregnant by using a locally approved contraception method throughout the study\n\n","\n\n * Has evidence of symptomatic venous or arterial thrombosis and/or asymptomatic intracardiac thrombosis confirmed by a transthoracic echocardiogram during study screening period\n * Has mechanical heart valve(s)\n * Has active bleeding or high risk of bleeding contraindicating treatment with anticoagulant\n * Takes antithrombotic therapy (other than low-dose aspirin) that is not protocol-related\n * Administration of rifampin is prohibited during the study and subjects on concomitant use of rifampin are excluded\n * Has any hepatic disease associated with coagulopathy leading to a clinically relevant bleeding risk\n * Has estimated glomerular filtration rate (eGFR) <30% of normal for age and size\n * Has stage 2 hypertension defined as blood pressure systolic and/or diastolic confirmed >99th percentile plus 5 mmHg\n * Has thrombocytopenia or life expectancy less than three months\n * Has had Fontan procedure with a history of or signs/symptoms suggestive of protein-losing enteropathy\n * Is pregnant or breastfeeding\n * Has a contraindication to the use of heparin and/or vitamin K antagonist (VKA)\n * Has any condition that, as judged by the Investigator, would place the participant at increased risk of harm if he/she participated in the study, including contraindicated medications identified in the protocol",{"$nulls":4},"Actual","2018-01-10","Actual","Anticipated","2021-03-01","Anticipated","2018-04-01","2018-01-04","2018-01-04","2018-04-19","Yes","Children\nPediatrics\nCardiac disease with potential for thromboembolic complications\nProphylactic treatment\nAnticoagulant drugs","Interventional","Prevention","Parallel Assignment","None (Open Label)","Randomized",null,"17 Years","All",null,"No","Yes\nDe-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at http://www.clinicalstudydatarequest.com. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://www.clinicalstudydatarequest.com/Study-Sponsors-DS-Details.aspx",{"$nulls":3},"Yes","No",{"$nulls":17},"2017-000475-90","EudraCT Number","Number of participants with combined bleeding events within the main treatment period|Number of participants with combined bleeding events during the entire trial (from first to the last dose plus 30 days)","Combined bleeding events include major and clinically-relevant non-major (CRNM) bleeding events per International Society on Thrombosis and Haemostasis (ISTH) definition occurring within the main treatment period|Combined bleeding events include major and clinically-relevant non-major (CRNM) bleeding events per International Society on Thrombosis and Haemostasis (ISTH) definition occurring on treatment","within 4 months (3-month Main Treatment Period + 30-day follow-up)|within 13 months (3-month Main Treatment Period + 9-month Extension Period + 30-day follow-up)","Number of participants with symptomatic thromboembolic events (TE) in the systemic arterial or venous pathways|Number of participants who died as a result of TE between randomization and the date of the last dose of study drug plus 30 days|Number of participants who died as a result of any cause between randomization and the date of the last dose of study drug plus 30 days","Symptomatic thromboembolic events (TE) in the systemic arterial or venous pathways include deep vein thrombosis (DVT), pulmonary embolism (PE), stroke, intracardiac thrombus and myocardial infarction (MI)|within 13 months","within 4 months|within 13 months",{"$nulls":3},"Linz, Austria, 4020|Hamilton, Canada, L8N 3Z5|Zadar, Croatia, 23000|Alexandria, Egypt, 21131|Beirut, Lebanon, 166830|Montpellier Cedex 5, France, 34295|Berlin, Germany, 13353|Budapest, Hungary, 1037|New Delhi, India, 110060|Beer Sheva, Israel, 8410101|Genova, Italy, 16147|Beirut, Lebanon, 1107 2020|Warszaw, Poland, 04-730|Barcelona, Spain, 08035|Adana, Turkey, 01330|Dnipro, Ukraine, 49100|Poltava, Ukraine, 36004|Glasgow, United Kingdom, G51 4Tf|Birmingham, Alabama, United States, 35233|Mesa, Arizona, United States, 85202|Los Angeles, California, United States, 90048|Gainesville, Florida, United States, 32610|Chicago, Illinois, United States, 60611|Lexington, Kentucky, United States, 40506|Saint Louis, Missouri, United States, 63110|New York, New York, United States, 10029|Charlotte, North Carolina, United States, 28204|Oklahoma City, Oklahoma, United States, 73104|Charlottesville, Virginia, United States, 22903|Seattle, Washington, United States, 98105","Alabama|Arizona|California|Florida|Illinois|Kentucky|Missouri|New York|North Carolina|Oklahoma|Virginia|Washington","Austria|Canada|Croatia|Egypt|France|Germany|Hungary|India|Israel|Italy|Lebanon|Poland|Spain|Turkey|Ukraine|United Kingdom|United States","Kepler UniversitÃ¤tsklinikum Med Campus Iv|Mcmaster Children's Hospital|General Hospital Zadar|Alexandria University Hospital|Hospital|HÃ´pital Arnaud De Villeneuve|Charite - Campus Virchow-Klinikum|Svabhegy Plusz Gyermek-Egeszsegugyi Kozpont Kft.|Sir Ganga Ram Hospital|Soroka University Medical Center|Istituto Giannina Gaslini-Ospedale Pediatrico Irccs|American University Of Beirut Medical Center|Instytut \"Pomnik - Centrum Zdrowia Dziecka\"|Hospital Universitari Vall D'Hebron|Cukurova University Medical Faculty|Ci Dnipropetrovsk Rcch Of Dnipropetrovsk Rc Dept Of Surgery Si Dnipropetrovsk Ma Of The Mohu|Umsa|Royal Hospital For Sick Children Yorkhill|University Of Alabama At Birmingham|Cardon Childrens Medical Center|Cedars Sinai Medical Center (Ecg)|University Of Florida College Of Medicine|Ann & Robert H. Lurie Children's Hospital Of Chicago|University Of Kentucky Ped Car|Washington University|Icahn School Of Medicine At Mount Sinai|Novant Health Heart And Vascular Institute|Ou Health Sciences Center|University Of Virginia Health System|Seattle Children's Hospital",{"$nulls":3},"Clinical Study Leader","2018-04-19","2020-05-25T16:36:10.011","2020-05-26T17:10:42.972","NCT03395639"]
["5ecbf3fa307e3d1b1f8d9ca6","NCT03395639","2018-04-27","Daiichi Sankyo","DSNKY","Recruiting","Edoxaban for Prevention of Blood Vessels Being Blocked by Clots (Thrombotic Events) in Children at Risk Because of Cardiac Disease","Edoxaban|Enoxaparin sodium|Heparin|Warfarin","FXa Inhibitor|AT III Activator|Thrombin Inhibitor|Heparin Inhibitor|Vitamin K Antagonist","No",null,"No",null,"Phase 3",2,150,"Anticipated","2017-11-16","2021-03-01",{"$nulls":5},"A committee will judge the safety and effectiveness of edoxaban and the regular treatment (standard of care).\n\nAll children in the study will receive free treatment. They will have a 2 in 3 chance to receive edoxaban, and a 1 in 3 chance to receive the standard of care for preventing blood clots.\n\nThe study will find out if edoxaban is safer and more effective than the standard of care.","The primary objective is to compare the safety of edoxaban with the standard of care (SOC) in pediatric subjects with cardiac diseases at risk of thromboembolic complications who need primary or secondary anticoagulant prophylaxis with regard to the combination of major and clinically relevant non-major (CRNM) bleeding per International Society on Thrombosis and Haemostasis [ISTH] definition.\n\nThe key secondary objective is to compare the efficacy of edoxaban against SOC with regard to the development of symptomatic thromboembolic events (TE) in the systemic arterial or venous pathways including deep vein thrombosis (DVT), pulmonary embolism (PE), stroke, intracardiac thrombus and myocardial infarction (MI), and asymptomatic intracardiac thrombus identified by cardiac imaging.","An Open-label, Randomised, Parallel-group, Multicentre, Observational Trial to Evaluate Safety and Efficacy of Edoxaban Tosylate in Children From 38 Weeks Gestational Age to Less Than 18 Years of Age With Cardiac Diseases at Risk of Thromboembolic Events","DU176b-C-U313","Cardiac Disease","Myocardial Infarction|Embolism|Pulmonary Embolism|Thrombosis|Stroke|Embolism and Thrombosis|Venous Thrombosis|Pulmonary Infarction","Heart Diseases|Vascular Diseases|Lung Diseases|Central Nervous System Diseases","Cardiovascular|Respiratory|Central Nervous System","Experimental|Active Comparator","Edoxaban|Standard of Care (SOC)","Two out of three participants will be randomized for treatment with edoxaban solution or tablets|One out of three participants will be randomized for treatment with the institution's SOC regimen","Drug","Edoxaban|Standard of Care (SOC)","Edoxaban 15 mg or 30 mg tablets for participants 12 to <18 years of age, or 60 mg edoxaban suspension (dosed as mg/kg) for participants under 12 years of age (and optionally, 12 or older), for oral administration|Standard of care could include low molecular weight heparin (LMWH) and/or VKA according to the clinical site's SOC treatment regimen","Lixiana | Savaysa|Warfarin/heparin | Enoxaparin","Edoxaban|Standard of Care (SOC)","\n\n * Is a child with cardiac disease who is at risk for thromboembolic complications and requires at least 3 months antithrombotic anticoagulant prophylaxis\n\nEither one of the following:\n\n 1. a child with cardiac disease who has a history of cardiac shunt occlusion/thrombosis, with shunt still in place (secondary prevention).OR\n    \n    \n 2. a child with cardiac disease who requires (including those already taking, and those not yet taking) anticoagulation for primary prevention of TE.\n\nCardiac conditions known to significantly increase the risk of thrombosis (hence, indications for primary TE prevention) are defined in Antithrombotic Therapy and Prevention of Thrombosis. Some examples of cardiac conditions at risk of thrombosis are Fontan surgery, heart failure, Kawasaki disease, and Blalock-Taussig and Glenn surgery.\n\n * Is a male or female child between 1 and <18 years of age (children between 38 weeks gestational age and 1 year of age will be included in the study, however, only after the safety and efficacy data of 50 subjects between 1 and <18 years of age in the edoxaban arm have been evaluated at the end of the 3-month treatment period)\n * Has parent(s)/legal guardian(s) or legally acceptable representative who is informed and provides signed consent for the child, to participate in the study with edoxaban treatment. Pediatric participants with appropriate intellectual maturity will be required to sign an assent form in addition to the signed informed consent from the parent(s)/legal guardian(s) or any legally acceptable representative.\n * If a female subject of childbearing potential, tests negative for pregnancy at Screening and consents to avoid becoming pregnant by using a locally approved contraception method throughout the study\n\n","\n\n * Has evidence of symptomatic venous or arterial thrombosis and/or asymptomatic intracardiac thrombosis confirmed by a transthoracic echocardiogram during study screening period\n * Has mechanical heart valve(s)\n * Has active bleeding or high risk of bleeding contraindicating treatment with anticoagulant\n * Takes antithrombotic therapy (other than low-dose aspirin) that is not protocol-related\n * Administration of rifampin is prohibited during the study and subjects on concomitant use of rifampin are excluded\n * Has any hepatic disease associated with coagulopathy leading to a clinically relevant bleeding risk\n * Has estimated glomerular filtration rate (eGFR) <30% of normal for age and size\n * Has stage 2 hypertension defined as blood pressure systolic and/or diastolic confirmed >99th percentile plus 5 mmHg\n * Has thrombocytopenia or life expectancy less than three months\n * Has had Fontan procedure with a history of or signs/symptoms suggestive of protein-losing enteropathy\n * Is pregnant or breastfeeding\n * Has a contraindication to the use of heparin and/or vitamin K antagonist (VKA)\n * Has any condition that, as judged by the Investigator, would place the participant at increased risk of harm if he/she participated in the study, including contraindicated medications identified in the protocol",{"$nulls":4},"Actual","2018-01-10","Actual","Anticipated","2021-03-01","Anticipated","2018-04-01","2018-01-04","2018-01-04","2018-04-25","Yes","Children\nPediatrics\nCardiac disease with potential for thromboembolic complications\nProphylactic treatment\nAnticoagulant drugs","Interventional","Prevention","Parallel Assignment","None (Open Label)","Randomized",null,"17 Years","All",null,"No","Yes\nDe-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://www.clinicalstudydatarequest.com//. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://www.clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-DS.aspx",{"$nulls":3},"Yes","No",{"$nulls":17},"2017-000475-90","EudraCT Number","Number of participants with combined bleeding events within the main treatment period|Number of participants with combined bleeding events during the entire trial (from first to the last dose plus 30 days)","Combined bleeding events include major and clinically-relevant non-major (CRNM) bleeding events per International Society on Thrombosis and Haemostasis (ISTH) definition occurring within the main treatment period|Combined bleeding events include major and clinically-relevant non-major (CRNM) bleeding events per International Society on Thrombosis and Haemostasis (ISTH) definition occurring on treatment","within 4 months (3-month Main Treatment Period + 30-day follow-up)|within 13 months (3-month Main Treatment Period + 9-month Extension Period + 30-day follow-up)","Number of participants with symptomatic thromboembolic events (TE) in the systemic arterial or venous pathways|Number of participants who died as a result of TE between randomization and the date of the last dose of study drug plus 30 days|Number of participants who died as a result of any cause between randomization and the date of the last dose of study drug plus 30 days","Symptomatic thromboembolic events (TE) in the systemic arterial or venous pathways include deep vein thrombosis (DVT), pulmonary embolism (PE), stroke, intracardiac thrombus and myocardial infarction (MI)|within 13 months","within 4 months|within 13 months",{"$nulls":3},"Linz, Austria, 4020|Hamilton, Canada, L8N 3Z5|Zadar, Croatia, 23000|Alexandria, Egypt, 21131|Beirut, Lebanon, 166830|Montpellier Cedex 5, France, 34295|Berlin, Germany, 13353|Budapest, Hungary, 1037|New Delhi, India, 110060|Beer Sheva, Israel, 8410101|Genova, Italy, 16147|Beirut, Lebanon, 1107 2020|Warszaw, Poland, 04-730|Barcelona, Spain, 08035|Adana, Turkey, 01330|Dnipro, Ukraine, 49100|Poltava, Ukraine, 36004|Glasgow, United Kingdom, G51 4Tf|Birmingham, Alabama, United States, 35233|Mesa, Arizona, United States, 85202|Los Angeles, California, United States, 90048|Gainesville, Florida, United States, 32610|Chicago, Illinois, United States, 60611|Lexington, Kentucky, United States, 40506|Saint Louis, Missouri, United States, 63110|New York, New York, United States, 10029|Charlotte, North Carolina, United States, 28204|Oklahoma City, Oklahoma, United States, 73104|Charlottesville, Virginia, United States, 22903|Seattle, Washington, United States, 98105","Alabama|Arizona|California|Florida|Illinois|Kentucky|Missouri|New York|North Carolina|Oklahoma|Virginia|Washington","Austria|Canada|Croatia|Egypt|France|Germany|Hungary|India|Israel|Italy|Lebanon|Poland|Spain|Turkey|Ukraine|United Kingdom|United States","Kepler UniversitÃ¤tsklinikum Med Campus Iv|Mcmaster Children's Hospital|General Hospital Zadar|Alexandria University Hospital|Hospital|HÃ´pital Arnaud De Villeneuve|Charite - Campus Virchow-Klinikum|Svabhegy Plusz Gyermek-Egeszsegugyi Kozpont Kft.|Sir Ganga Ram Hospital|Soroka University Medical Center|Istituto Giannina Gaslini-Ospedale Pediatrico Irccs|American University Of Beirut Medical Center|Instytut \"Pomnik - Centrum Zdrowia Dziecka\"|Hospital Universitari Vall D'Hebron|Cukurova University Medical Faculty|Ci Dnipropetrovsk Rcch Of Dnipropetrovsk Rc Dept Of Surgery Si Dnipropetrovsk Ma Of The Mohu|Umsa|Royal Hospital For Sick Children Yorkhill|University Of Alabama At Birmingham|Cardon Childrens Medical Center|Cedars Sinai Medical Center (Ecg)|University Of Florida College Of Medicine|Ann & Robert H. Lurie Children's Hospital Of Chicago|University Of Kentucky Ped Car|Washington University|Icahn School Of Medicine At Mount Sinai|Novant Health Heart And Vascular Institute|Ou Health Sciences Center|University Of Virginia Health System|Seattle Children's Hospital",{"$nulls":3},"Clinical Study Leader","2018-04-25","2020-05-25T16:36:10.430","2020-05-26T17:10:42.972","NCT03395639"]
["5ecbf3fafeab101b15530846","NCT03395639","2018-05-24","Daiichi Sankyo","DSNKY","Recruiting","Edoxaban for Prevention of Blood Vessels Being Blocked by Clots (Thrombotic Events) in Children at Risk Because of Cardiac Disease","Edoxaban|Enoxaparin sodium|Heparin|Warfarin","FXa Inhibitor|AT III Activator|Thrombin Inhibitor|Heparin Inhibitor|Vitamin K Antagonist","No",null,"No",null,"Phase 3",2,150,"Anticipated","2017-11-16","2021-03-01",{"$nulls":5},"A committee will judge the safety and effectiveness of edoxaban and the regular treatment (standard of care).\n\nAll children in the study will receive free treatment. They will have a 2 in 3 chance to receive edoxaban, and a 1 in 3 chance to receive the standard of care for preventing blood clots.\n\nThe study will find out if edoxaban is safer and more effective than the standard of care.","The primary objective is to compare the safety of edoxaban with the standard of care (SOC) in pediatric subjects with cardiac diseases at risk of thromboembolic complications who need primary or secondary anticoagulant prophylaxis with regard to the combination of major and clinically relevant non-major (CRNM) bleeding per International Society on Thrombosis and Haemostasis [ISTH] definition.\n\nThe key secondary objective is to compare the efficacy of edoxaban against SOC with regard to the development of symptomatic thromboembolic events (TE) in the systemic arterial or venous pathways including deep vein thrombosis (DVT), pulmonary embolism (PE), stroke, intracardiac thrombus and myocardial infarction (MI), and asymptomatic intracardiac thrombus identified by cardiac imaging.","An Open-label, Randomised, Parallel-group, Multicentre, Observational Trial to Evaluate Safety and Efficacy of Edoxaban Tosylate in Children From 38 Weeks Gestational Age to Less Than 18 Years of Age With Cardiac Diseases at Risk of Thromboembolic Events","DU176b-C-U313","Cardiac Disease","Myocardial Infarction|Embolism|Pulmonary Embolism|Thrombosis|Stroke|Embolism and Thrombosis|Venous Thrombosis|Pulmonary Infarction","Heart Diseases|Vascular Diseases|Lung Diseases|Central Nervous System Diseases","Cardiovascular|Respiratory|Central Nervous System","Experimental|Active Comparator","Edoxaban|Standard of Care (SOC)","Two out of three participants will be randomized for treatment with edoxaban solution or tablets|One out of three participants will be randomized for treatment with the institution's SOC regimen","Drug","Edoxaban|Standard of Care (SOC)","Edoxaban 15 mg or 30 mg tablets for participants 12 to <18 years of age, or 60 mg edoxaban suspension (dosed as mg/kg) for participants under 12 years of age (and optionally, 12 or older), for oral administration|Standard of care could include low molecular weight heparin (LMWH) and/or VKA according to the clinical site's SOC treatment regimen","Lixiana | Savaysa|Warfarin/heparin | Enoxaparin","Edoxaban|Standard of Care (SOC)","\n\n * Is a child with cardiac disease who is at risk for thromboembolic complications and requires at least 3 months antithrombotic anticoagulant prophylaxis\n\nEither one of the following:\n\n 1. a child with cardiac disease who has a history of cardiac shunt occlusion/thrombosis, with shunt still in place (secondary prevention).OR\n    \n    \n 2. a child with cardiac disease who requires (including those already taking, and those not yet taking) anticoagulation for primary prevention of TE.\n\nCardiac conditions known to significantly increase the risk of thrombosis (hence, indications for primary TE prevention) are defined in Antithrombotic Therapy and Prevention of Thrombosis. Some examples of cardiac conditions at risk of thrombosis are Fontan surgery, heart failure, Kawasaki disease, and Blalock-Taussig and Glenn surgery.\n\n * Is a male or female child between 1 and <18 years of age (children between 38 weeks gestational age and 1 year of age will be included in the study, however, only after the safety and efficacy data of 50 subjects between 1 and <18 years of age in the edoxaban arm have been evaluated at the end of the 3-month treatment period)\n * Has parent(s)/legal guardian(s) or legally acceptable representative who is informed and provides signed consent for the child, to participate in the study with edoxaban treatment. Pediatric participants with appropriate intellectual maturity will be required to sign an assent form in addition to the signed informed consent from the parent(s)/legal guardian(s) or any legally acceptable representative.\n * If a female subject of childbearing potential, tests negative for pregnancy at Screening and consents to avoid becoming pregnant by using a locally approved contraception method throughout the study\n\n","\n\n * Has evidence of symptomatic venous or arterial thrombosis and/or asymptomatic intracardiac thrombosis confirmed by a transthoracic echocardiogram during study screening period\n * Has mechanical heart valve(s)\n * Has active bleeding or high risk of bleeding contraindicating treatment with anticoagulant\n * Takes antithrombotic therapy (other than low-dose aspirin) that is not protocol-related\n * Administration of rifampin is prohibited during the study and subjects on concomitant use of rifampin are excluded\n * Has any hepatic disease associated with coagulopathy leading to a clinically relevant bleeding risk\n * Has estimated glomerular filtration rate (eGFR) <30% of normal for age and size\n * Has stage 2 hypertension defined as blood pressure systolic and/or diastolic confirmed >99th percentile plus 5 mmHg\n * Has thrombocytopenia or life expectancy less than three months\n * Has had Fontan procedure with a history of or signs/symptoms suggestive of protein-losing enteropathy\n * Is pregnant or breastfeeding\n * Has a contraindication to the use of heparin and/or vitamin K antagonist (VKA)\n * Has any condition that, as judged by the Investigator, would place the participant at increased risk of harm if he/she participated in the study, including contraindicated medications identified in the protocol",{"$nulls":4},"Actual","2018-01-10","Actual","Anticipated","2021-03-01","Anticipated","2018-05-01","2018-01-04","2018-01-04","2018-05-23","Yes","Children\nPediatrics\nCardiac disease with potential for thromboembolic complications\nProphylactic treatment\nAnticoagulant drugs","Interventional","Prevention","Parallel Assignment","None (Open Label)","Randomized",null,"17 Years","All",null,"No","Yes\nDe-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://www.clinicalstudydatarequest.com//. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://www.clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-DS.aspx",{"$nulls":3},"Yes","No",{"$nulls":17},"2017-000475-90","EudraCT Number","Number of participants with combined bleeding events within the main treatment period|Number of participants with combined bleeding events during the entire trial (from first to the last dose plus 30 days)","Combined bleeding events include major and clinically-relevant non-major (CRNM) bleeding events per International Society on Thrombosis and Haemostasis (ISTH) definition occurring within the main treatment period|Combined bleeding events include major and clinically-relevant non-major (CRNM) bleeding events per International Society on Thrombosis and Haemostasis (ISTH) definition occurring on treatment","within 4 months (3-month Main Treatment Period + 30-day follow-up)|within 13 months (3-month Main Treatment Period + 9-month Extension Period + 30-day follow-up)","Number of participants with symptomatic thromboembolic events (TE) in the systemic arterial or venous pathways|Number of participants who died as a result of TE between randomization and the date of the last dose of study drug plus 30 days|Number of participants who died as a result of any cause between randomization and the date of the last dose of study drug plus 30 days","Symptomatic thromboembolic events (TE) in the systemic arterial or venous pathways include deep vein thrombosis (DVT), pulmonary embolism (PE), stroke, intracardiac thrombus and myocardial infarction (MI)|within 13 months","within 4 months|within 13 months",{"$nulls":3},"Linz, Austria, 4020|Hamilton, Ontario, Canada, L8N 3Z5|MontrÃ©al, Quebec, Canada, H3T 1C5|Zadar, Croatia, 23000|Zagazig, Al Sharkeya, Egypt, 44519|Alexandria, Egypt, 21131|Pessac, Gironde, France, 33600|Toulouse Cedex 9, Haute Garonne, France, 31059|Montpellier, Herault, France, 34295|Beirut, Lebanon, 166830|Rennes Cedex 09, Ille Et Vilaine, France, 35033|Paris Cedex 15, Paris, France, 75015|Stuttgart, Baden Wuerttemberg, Germany, 70174|Berlin, Germany, 13353|Giessen, Hessen, Germany, 35385|GÃ¶ttingen, Niedersachsen, Germany, 37075|Budapest, Hungary, 1096|New Delhi, Delhi, India, 110060|Surat, Gujarat, India, 395002|Beer Sheva, Israel, 8410101|Genova, Italy, 16147|Turin, Torino, Italy, 10126|Beirut, Lebanon, 11-0236|Warszaw, Poland, 04-730|Barcelona, Spain, 08035|Adana, Turkey, 01330|Edirne, Kayseri, Turkey, 38039|Poltava, Ukraine, 36011|London, Greater London, United Kingdom, Sw3 6Hp|Leicester, Leicestershire, United Kingdom, Le3 9Qp|Glasgow, Strathclyde, United Kingdom, G51 4Tf|Birmingham, Alabama, United States, 35233|Mesa, Arizona, United States, 85202|Los Angeles, California, United States, 90048|Gainesville, Florida, United States, 32610|Chicago, Illinois, United States, 60611|Lexington, Kentucky, United States, 40536|Saint Louis, Missouri, United States, 63110|New York, New York, United States, 10029|Charlotte, North Carolina, United States, 28204|Oklahoma City, Oklahoma, United States, 73104|Charlottesville, Virginia, United States, 22903|Seattle, Washington, United States, 98105","Alabama|Arizona|California|Florida|Illinois|Kentucky|Missouri|New York|North Carolina|Oklahoma|Virginia|Washington","Austria|Canada|Croatia|Egypt|France|Germany|Hungary|India|Israel|Italy|Lebanon|Poland|Spain|Turkey|Ukraine|United Kingdom|United States","Kepler UniversitÃ¤tsklinikum Med Campus Iv|Ontario Mcmaster Children's Hospital|Quebec Chu Sainte-Justine|General Hospital Zadar|Al Sharkeya Zagazig University Hospital|Alexandria Clinical Research Center, Faculty Of Medicine|Gironde Hopital Cardiologique Haut-Leveque, Service Des Maladies Cardiovasculaires CongÃ©nitales|Haute Garonne HÃ´pital Des Enfants, BÃ¢timent Modulaire|Herault HÃ´pital Arnaud De Villeneuve|Hospital|Ille Et Vilaine Chu Pontchaillou|Paris Pediatric Cardiology Department, Hospital Necker Enfants Malades, Aphp, UniversitÃ© Paris Descartes|Baden Wuerttemberg Klinikum Stuttgart-Olgahospital|Charite - Campus Virchow-Klinikum|Hessen Pediatric Heart Center Giessen|Niedersachsen Universitaetsmedizin Goettingen|Gottsegen Gyorgy Orszagos Kardiologiai Intezet|Delhi Sir Ganga Ram Hospital|Gujarat Nirmal Hospital Private Limited|Soroka University Medical Center|Istituto Giannina Gaslini-Ospedale Pediatrico Irccs|Torino Ospedale Infantile Regina Margherita|Children's Heart Centre At The American University Of Beirut Medical Center|The Children's Memorial Health Institute, Al. Dzieci Polskich|Hospital Universitari Vall D'Hebron|Cukurova University Medical Faculty|Kayseri Erciyes University Medical Faculty|\"Ukrainian Medical Stomatological Academy\", Department Of Pediatrics|, Greater London Royal Brompton Hospital|, Leicestershire Glenfield Hospital|, Strathclyde Ward 2B, Royal Hospital For Children|University Of Alabama At Birmingham|Cardon Childrens Medical Center|Cedars Sinai Medical Center (Ecg)|University Of Florida College Of Medicine|Ann & Robert H. Lurie Children's Hospital Of Chicago|University Of Kentucky Ped Car|Washington University|Mt Sinai Pediatric Cardiology|Novant Health Heart And Vascular Institute|Ou Health Sciences Center|University Of Virginia Health System|Seattle Children's Research Institute",{"$nulls":3},"Clinical Study Leader","2018-05-23","2020-05-25T16:36:10.521","2020-05-26T17:10:42.972","NCT03395639"]
["5ecbf3fa11702c1b1b916a26","NCT03395639","2018-06-26","Daiichi Sankyo","DSNKY","Recruiting","Edoxaban for Prevention of Blood Vessels Being Blocked by Clots (Thrombotic Events) in Children at Risk Because of Cardiac Disease","Edoxaban|Enoxaparin sodium|Heparin|Warfarin","FXa Inhibitor|AT III Activator|Thrombin Inhibitor|Heparin Inhibitor|Vitamin K Antagonist","No",null,"No",null,"Phase 3",2,150,"Anticipated","2017-11-16","2021-03-01",{"$nulls":5},"A committee will judge the safety and effectiveness of edoxaban and the regular treatment (standard of care).\n\nAll children in the study will receive free treatment. They will have a 2 in 3 chance to receive edoxaban, and a 1 in 3 chance to receive the standard of care for preventing blood clots.\n\nThe study will find out if edoxaban is safer and more effective than the standard of care.","The primary objective is to compare the safety of edoxaban with the standard of care (SOC) in pediatric subjects with cardiac diseases at risk of thromboembolic complications who need primary or secondary anticoagulant prophylaxis with regard to the combination of major and clinically relevant non-major (CRNM) bleeding per International Society on Thrombosis and Haemostasis [ISTH] definition.\n\nThe key secondary objective is to compare the efficacy of edoxaban against SOC with regard to the development of symptomatic thromboembolic events (TE) in the systemic arterial or venous pathways including deep vein thrombosis (DVT), pulmonary embolism (PE), stroke, intracardiac thrombus and myocardial infarction (MI), and asymptomatic intracardiac thrombus identified by cardiac imaging.","An Open-label, Randomised, Parallel-group, Multicentre, Observational Trial to Evaluate Safety and Efficacy of Edoxaban Tosylate in Children From 38 Weeks Gestational Age to Less Than 18 Years of Age With Cardiac Diseases at Risk of Thromboembolic Events","DU176b-C-U313","Cardiac Disease","Myocardial Infarction|Embolism|Pulmonary Embolism|Thrombosis|Stroke|Embolism and Thrombosis|Venous Thrombosis|Pulmonary Infarction","Heart Diseases|Vascular Diseases|Lung Diseases|Central Nervous System Diseases","Cardiovascular|Respiratory|Central Nervous System","Experimental|Active Comparator","Edoxaban|Standard of Care (SOC)","Two out of three participants will be randomized for treatment with edoxaban solution or tablets|One out of three participants will be randomized for treatment with the institution's SOC regimen","Drug","Edoxaban|Standard of Care (SOC)","Edoxaban 15 mg or 30 mg tablets for participants 12 to <18 years of age, or 60 mg edoxaban suspension (dosed as mg/kg) for participants under 12 years of age (and optionally, 12 or older), for oral administration|Standard of care could include low molecular weight heparin (LMWH) and/or VKA according to the clinical site's SOC treatment regimen","Lixiana | Savaysa|Warfarin/heparin | Enoxaparin","Edoxaban|Standard of Care (SOC)","\n\n * Is a child with cardiac disease who is at risk for thromboembolic complications and requires at least 3 months antithrombotic anticoagulant prophylaxis\n\nEither one of the following:\n\n 1. a child with cardiac disease who has a history of cardiac shunt occlusion/thrombosis, with shunt still in place (secondary prevention).OR\n    \n    \n 2. a child with cardiac disease who requires (including those already taking, and those not yet taking) anticoagulation for primary prevention of TE.\n\nCardiac conditions known to significantly increase the risk of thrombosis (hence, indications for primary TE prevention) are defined in Antithrombotic Therapy and Prevention of Thrombosis. Some examples of cardiac conditions at risk of thrombosis are Fontan surgery, heart failure, Kawasaki disease, and Blalock-Taussig and Glenn surgery.\n\n * Is a male or female child between 1 and <18 years of age (children between 38 weeks gestational age and 1 year of age will be included in the study, however, only after the safety and efficacy data of 50 subjects between 1 and <18 years of age in the edoxaban arm have been evaluated at the end of the 3-month treatment period)\n * Has parent(s)/legal guardian(s) or legally acceptable representative who is informed and provides signed consent for the child, to participate in the study with edoxaban treatment. Pediatric participants with appropriate intellectual maturity will be required to sign an assent form in addition to the signed informed consent from the parent(s)/legal guardian(s) or any legally acceptable representative.\n * If a female subject of childbearing potential, tests negative for pregnancy at Screening and consents to avoid becoming pregnant by using a locally approved contraception method throughout the study\n\n","\n\n * Has evidence of symptomatic venous or arterial thrombosis and/or asymptomatic intracardiac thrombosis confirmed by a transthoracic echocardiogram during study screening period\n * Has mechanical heart valve(s)\n * Has active bleeding or high risk of bleeding contraindicating treatment with anticoagulant\n * Takes antithrombotic therapy (other than low-dose aspirin) that is not protocol-related\n * Administration of rifampin is prohibited during the study and subjects on concomitant use of rifampin are excluded\n * Has any hepatic disease associated with coagulopathy leading to a clinically relevant bleeding risk\n * Has estimated glomerular filtration rate (eGFR) <30% of normal for age and size\n * Has stage 2 hypertension defined as blood pressure systolic and/or diastolic confirmed >99th percentile plus 5 mmHg\n * Has thrombocytopenia or life expectancy less than three months\n * Has had Fontan procedure with a history of or signs/symptoms suggestive of protein-losing enteropathy\n * Is pregnant or breastfeeding\n * Has a contraindication to the use of heparin and/or vitamin K antagonist (VKA)\n * Has any condition that, as judged by the Investigator, would place the participant at increased risk of harm if he/she participated in the study, including contraindicated medications identified in the protocol",{"$nulls":4},"Actual","2018-01-10","Actual","Anticipated","2021-03-01","Anticipated","2018-06-01","2018-01-04","2018-01-04","2018-06-25","Yes","Children\nPediatrics\nCardiac disease with potential for thromboembolic complications\nProphylactic treatment\nAnticoagulant drugs","Interventional","Prevention","Parallel Assignment","None (Open Label)","Randomized",null,"17 Years","All",null,"No","Yes\nDe-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://www.clinicalstudydatarequest.com//. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://www.clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-DS.aspx",{"$nulls":3},"Yes","No",{"$nulls":17},"2017-000475-90","EudraCT Number","Number of participants with combined bleeding events within the main treatment period|Number of participants with combined bleeding events during the entire trial (from first to the last dose plus 30 days)","Combined bleeding events include major and clinically-relevant non-major (CRNM) bleeding events per International Society on Thrombosis and Haemostasis (ISTH) definition occurring within the main treatment period|Combined bleeding events include major and clinically-relevant non-major (CRNM) bleeding events per International Society on Thrombosis and Haemostasis (ISTH) definition occurring on treatment","within 4 months (3-month Main Treatment Period + 30-day follow-up)|within 13 months (3-month Main Treatment Period + 9-month Extension Period + 30-day follow-up)","Number of participants with symptomatic thromboembolic events (TE) in the systemic arterial or venous pathways|Number of participants who died as a result of TE between randomization and the date of the last dose of study drug plus 30 days|Number of participants who died as a result of any cause between randomization and the date of the last dose of study drug plus 30 days","Symptomatic thromboembolic events (TE) in the systemic arterial or venous pathways include deep vein thrombosis (DVT), pulmonary embolism (PE), stroke, intracardiac thrombus and myocardial infarction (MI)|within 13 months","within 4 months|within 13 months",{"$nulls":3},"Charlotte, North Carolina, United States, 28204|Seattle, Washington, United States, 98105","North Carolina|Washington","United States","Novant Health Heart And Vascular Institute|Seattle Children's Research Institute",{"$nulls":3},"Clinical Study Leader","2018-06-25","2020-05-25T16:36:10.408","2020-05-26T17:10:42.972","NCT03395639"]
["5ecbf3fafe30261b1a048216","NCT03395639","2018-08-01","Daiichi Sankyo","DSNKY","Recruiting","Edoxaban for Prevention of Blood Vessels Being Blocked by Clots (Thrombotic Events) in Children at Risk Because of Cardiac Disease","Edoxaban|Enoxaparin sodium|Heparin|Warfarin","FXa Inhibitor|AT III Activator|Thrombin Inhibitor|Heparin Inhibitor|Vitamin K Antagonist","No",null,"No",null,"Phase 3",2,150,"Anticipated","2017-11-16","2021-03-01",{"$nulls":5},"A committee will judge the safety and effectiveness of edoxaban and the regular treatment (standard of care).\n\nAll children in the study will receive free treatment. They will have a 2 in 3 chance to receive edoxaban, and a 1 in 3 chance to receive the standard of care for preventing blood clots.\n\nThe study will find out if edoxaban is safer and more effective than the standard of care.","The primary objective is to compare the safety of edoxaban with the standard of care (SOC) in pediatric subjects with cardiac diseases at risk of thromboembolic complications who need primary or secondary anticoagulant prophylaxis with regard to the combination of major and clinically relevant non-major (CRNM) bleeding per International Society on Thrombosis and Haemostasis [ISTH] definition.\n\nThe key secondary objective is to compare the efficacy of edoxaban against SOC with regard to the development of symptomatic thromboembolic events (TE) in the systemic arterial or venous pathways including deep vein thrombosis (DVT), pulmonary embolism (PE), stroke, intracardiac thrombus and myocardial infarction (MI), and asymptomatic intracardiac thrombus identified by cardiac imaging.","An Open-label, Randomised, Parallel-group, Multicentre, Observational Trial to Evaluate Safety and Efficacy of Edoxaban Tosylate in Children From 38 Weeks Gestational Age to Less Than 18 Years of Age With Cardiac Diseases at Risk of Thromboembolic Events","DU176b-C-U313","Cardiac Disease","Myocardial Infarction|Embolism|Pulmonary Embolism|Thrombosis|Stroke|Embolism and Thrombosis|Venous Thrombosis|Pulmonary Infarction","Heart Diseases|Vascular Diseases|Lung Diseases|Central Nervous System Diseases","Cardiovascular|Respiratory|Central Nervous System","Experimental|Active Comparator","Edoxaban|Standard of Care (SOC)","Two out of three participants will be randomized for treatment with edoxaban solution or tablets|One out of three participants will be randomized for treatment with the institution's SOC regimen","Drug","Edoxaban|Standard of Care (SOC)","Edoxaban 15 mg or 30 mg tablets for participants 12 to <18 years of age, or 60 mg edoxaban suspension (dosed as mg/kg) for participants under 12 years of age (and optionally, 12 or older), for oral administration|Standard of care could include low molecular weight heparin (LMWH) and/or VKA according to the clinical site's SOC treatment regimen","Lixiana | Savaysa|Warfarin/heparin | Enoxaparin","Edoxaban|Standard of Care (SOC)","\n\n * Is a child with cardiac disease who is at risk for thromboembolic complications and requires at least 3 months antithrombotic anticoagulant prophylaxis\n\nEither one of the following:\n\n 1. a child with cardiac disease who has a history of cardiac shunt occlusion/thrombosis, with shunt still in place (secondary prevention).OR\n    \n    \n 2. a child with cardiac disease who requires (including those already taking, and those not yet taking) anticoagulation for primary prevention of TE.\n\nCardiac conditions known to significantly increase the risk of thrombosis (hence, indications for primary TE prevention) are defined in Antithrombotic Therapy and Prevention of Thrombosis. Some examples of cardiac conditions at risk of thrombosis are Fontan surgery, heart failure, Kawasaki disease, and Blalock-Taussig and Glenn surgery.\n\n * Is a male or female child between 1 and <18 years of age (children between 38 weeks gestational age and 1 year of age will be included in the study, however, only after the safety and efficacy data of 50 subjects between 1 and <18 years of age in the edoxaban arm have been evaluated at the end of the 3-month treatment period)\n * Has parent(s)/legal guardian(s) or legally acceptable representative who is informed and provides signed consent for the child, to participate in the study with edoxaban treatment. Pediatric participants with appropriate intellectual maturity will be required to sign an assent form in addition to the signed informed consent from the parent(s)/legal guardian(s) or any legally acceptable representative.\n * If a female subject of childbearing potential, tests negative for pregnancy at Screening and consents to avoid becoming pregnant by using a locally approved contraception method throughout the study\n\n","\n\n * Has evidence of symptomatic venous or arterial thrombosis and/or asymptomatic intracardiac thrombosis confirmed by a transthoracic echocardiogram during study screening period\n * Has mechanical heart valve(s)\n * Has active bleeding or high risk of bleeding contraindicating treatment with anticoagulant\n * Takes antithrombotic therapy (other than low-dose aspirin) that is not protocol-related\n * Administration of rifampin is prohibited during the study and subjects on concomitant use of rifampin are excluded\n * Has any hepatic disease associated with coagulopathy leading to a clinically relevant bleeding risk\n * Has estimated glomerular filtration rate (eGFR) <30% of normal for age and size\n * Has stage 2 hypertension defined as blood pressure systolic and/or diastolic confirmed >99th percentile plus 5 mmHg\n * Has thrombocytopenia or life expectancy less than three months\n * Has had Fontan procedure with a history of or signs/symptoms suggestive of protein-losing enteropathy\n * Is pregnant or breastfeeding\n * Has a contraindication to the use of heparin and/or vitamin K antagonist (VKA)\n * Has any condition that, as judged by the Investigator, would place the participant at increased risk of harm if he/she participated in the study, including contraindicated medications identified in the protocol",{"$nulls":4},"Actual","2018-01-10","Actual","Anticipated","2021-03-01","Anticipated","2018-07-01","2018-01-04","2018-01-04","2018-07-31","Yes","Children\nPediatrics\nCardiac disease with potential for thromboembolic complications\nProphylactic treatment\nAnticoagulant drugs","Interventional","Prevention","Parallel Assignment","None (Open Label)","Randomized",null,"17 Years","All",null,"No","Yes\nDe-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://www.clinicalstudydatarequest.com//. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://www.clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-DS.aspx",{"$nulls":3},"Yes","No",{"$nulls":17},"2017-000475-90","EudraCT Number","Number of participants with combined bleeding events within the main treatment period|Number of participants with combined bleeding events during the entire trial (from first to the last dose plus 30 days)","Combined bleeding events include major and clinically-relevant non-major (CRNM) bleeding events per International Society on Thrombosis and Haemostasis (ISTH) definition occurring within the main treatment period|Combined bleeding events include major and clinically-relevant non-major (CRNM) bleeding events per International Society on Thrombosis and Haemostasis (ISTH) definition occurring on treatment","within 4 months (3-month Main Treatment Period + 30-day follow-up)|within 13 months (3-month Main Treatment Period + 9-month Extension Period + 30-day follow-up)","Number of participants with symptomatic thromboembolic events (TE) in the systemic arterial or venous pathways|Number of participants who died as a result of TE between randomization and the date of the last dose of study drug plus 30 days|Number of participants who died as a result of any cause between randomization and the date of the last dose of study drug plus 30 days","Symptomatic thromboembolic events (TE) in the systemic arterial or venous pathways include deep vein thrombosis (DVT), pulmonary embolism (PE), stroke, intracardiac thrombus and myocardial infarction (MI)|within 13 months","within 4 months|within 13 months",{"$nulls":3},"Linz, Austria, 4020|Birmingham, Alabama, United States, 35233|Charlotte, North Carolina, United States, 28204|Seattle, Washington, United States, 98105","Alabama|North Carolina|Washington","Austria|United States","Kepler UniversitÃ¤tsklinikum Med Campus Iv|University Of Alabama At Birmingham|Novant Health Heart And Vascular Institute|Seattle Children's Research Institute",{"$nulls":3},"Clinical Study Leader","2018-07-31","2020-05-25T16:36:10.549","2020-05-26T17:10:42.972","NCT03395639"]
["5ecbf3fa11702c1b1b916a27","NCT03395639","2018-08-22","Daiichi Sankyo","DSNKY","Recruiting","Edoxaban for Prevention of Blood Vessels Being Blocked by Clots (Thrombotic Events) in Children at Risk Because of Cardiac Disease","Edoxaban|Enoxaparin sodium|Heparin|Warfarin","FXa Inhibitor|AT III Activator|Thrombin Inhibitor|Heparin Inhibitor|Vitamin K Antagonist","No",null,"No",null,"Phase 3",2,150,"Anticipated","2017-11-16","2021-03-01",{"$nulls":5},"A committee will judge the safety and effectiveness of edoxaban and the regular treatment (standard of care).\n\nAll children in the study will receive free treatment. They will have a 2 in 3 chance to receive edoxaban, and a 1 in 3 chance to receive the standard of care for preventing blood clots.\n\nThe study will find out if edoxaban is safer and more effective than the standard of care.","The primary objective is to compare the safety of edoxaban with the standard of care (SOC) in pediatric subjects with cardiac diseases at risk of thromboembolic complications who need primary or secondary anticoagulant prophylaxis with regard to the combination of major and clinically relevant non-major (CRNM) bleeding per International Society on Thrombosis and Haemostasis [ISTH] definition.\n\nThe key secondary objective is to compare the efficacy of edoxaban against SOC with regard to the development of symptomatic thromboembolic events (TE) in the systemic arterial or venous pathways including deep vein thrombosis (DVT), pulmonary embolism (PE), stroke, intracardiac thrombus and myocardial infarction (MI), and asymptomatic intracardiac thrombus identified by cardiac imaging.","An Open-label, Randomised, Parallel-group, Multicentre, Observational Trial to Evaluate Safety and Efficacy of Edoxaban Tosylate in Children From 38 Weeks Gestational Age to Less Than 18 Years of Age With Cardiac Diseases at Risk of Thromboembolic Events","DU176b-C-U313","Cardiac Disease","Myocardial Infarction|Embolism|Pulmonary Embolism|Thrombosis|Stroke|Embolism and Thrombosis|Venous Thrombosis|Pulmonary Infarction","Heart Diseases|Vascular Diseases|Lung Diseases|Central Nervous System Diseases","Cardiovascular|Respiratory|Central Nervous System","Experimental|Active Comparator","Edoxaban|Standard of Care (SOC)","Two out of three participants will be randomized for treatment with edoxaban solution or tablets|One out of three participants will be randomized for treatment with the institution's SOC regimen","Drug","Edoxaban|Standard of Care (SOC)","Edoxaban 15 mg or 30 mg tablets for participants 12 to <18 years of age, or 60 mg edoxaban suspension (dosed as mg/kg) for participants under 12 years of age (and optionally, 12 or older), for oral administration|Standard of care could include low molecular weight heparin (LMWH) and/or VKA according to the clinical site's SOC treatment regimen","Lixiana | Savaysa|Warfarin/heparin | Enoxaparin","Edoxaban|Standard of Care (SOC)","\n\n * Is a child with cardiac disease who is at risk for thromboembolic complications and requires at least 3 months antithrombotic anticoagulant prophylaxis\n\nEither one of the following:\n\n 1. a child with cardiac disease who has a history of cardiac shunt occlusion/thrombosis, with shunt still in place (secondary prevention).OR\n    \n    \n 2. a child with cardiac disease who requires (including those already taking, and those not yet taking) anticoagulation for primary prevention of TE.\n\nCardiac conditions known to significantly increase the risk of thrombosis (hence, indications for primary TE prevention) are defined in Antithrombotic Therapy and Prevention of Thrombosis. Some examples of cardiac conditions at risk of thrombosis are Fontan surgery, heart failure, Kawasaki disease, and Blalock-Taussig and Glenn surgery.\n\n * Is a male or female child between 1 and <18 years of age (children between 38 weeks gestational age and 1 year of age will be included in the study, however, only after the safety and efficacy data of 50 subjects between 1 and <18 years of age in the edoxaban arm have been evaluated at the end of the 3-month treatment period)\n * Has parent(s)/legal guardian(s) or legally acceptable representative who is informed and provides signed consent for the child, to participate in the study with edoxaban treatment. Pediatric participants with appropriate intellectual maturity will be required to sign an assent form in addition to the signed informed consent from the parent(s)/legal guardian(s) or any legally acceptable representative.\n * If a female subject of childbearing potential, tests negative for pregnancy at Screening and consents to avoid becoming pregnant by using a locally approved contraception method throughout the study\n\n","\n\n * Has evidence of symptomatic venous or arterial thrombosis and/or asymptomatic intracardiac thrombosis confirmed by a transthoracic echocardiogram during study screening period\n * Has mechanical heart valve(s)\n * Has active bleeding or high risk of bleeding contraindicating treatment with anticoagulant\n * Takes antithrombotic therapy (other than low-dose aspirin) that is not protocol-related\n * Administration of rifampin is prohibited during the study and subjects on concomitant use of rifampin are excluded\n * Has any hepatic disease associated with coagulopathy leading to a clinically relevant bleeding risk\n * Has estimated glomerular filtration rate (eGFR) <30% of normal for age and size\n * Has stage 2 hypertension defined as blood pressure systolic and/or diastolic confirmed >99th percentile plus 5 mmHg\n * Has thrombocytopenia or life expectancy less than three months\n * Has had Fontan procedure with a history of or signs/symptoms suggestive of protein-losing enteropathy\n * Is pregnant or breastfeeding\n * Has a contraindication to the use of heparin and/or vitamin K antagonist (VKA)\n * Has any condition that, as judged by the Investigator, would place the participant at increased risk of harm if he/she participated in the study, including contraindicated medications identified in the protocol",{"$nulls":4},"Actual","2018-01-10","Actual","Anticipated","2021-03-01","Anticipated","2018-08-01","2018-01-04","2018-01-04","2018-08-21","Yes","Children\nPediatrics\nCardiac disease with potential for thromboembolic complications\nProphylactic treatment\nAnticoagulant drugs","Interventional","Prevention","Parallel Assignment","None (Open Label)","Randomized",null,"17 Years","All",null,"No","Yes\nDe-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://www.clinicalstudydatarequest.com//. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://www.clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-DS.aspx",{"$nulls":3},"Yes","No",{"$nulls":17},"2017-000475-90","EudraCT Number","Number of participants with combined bleeding events within the main treatment period|Number of participants with combined bleeding events during the entire trial (from first to the last dose plus 30 days)","Combined bleeding events include major and clinically-relevant non-major (CRNM) bleeding events per International Society on Thrombosis and Haemostasis (ISTH) definition occurring within the main treatment period|Combined bleeding events include major and clinically-relevant non-major (CRNM) bleeding events per International Society on Thrombosis and Haemostasis (ISTH) definition occurring on treatment","within 4 months (3-month Main Treatment Period + 30-day follow-up)|within 13 months (3-month Main Treatment Period + 9-month Extension Period + 30-day follow-up)","Number of participants with symptomatic thromboembolic events (TE) in the systemic arterial or venous pathways|Number of participants who died as a result of TE between randomization and the date of the last dose of study drug plus 30 days|Number of participants who died as a result of any cause between randomization and the date of the last dose of study drug plus 30 days","Symptomatic thromboembolic events (TE) in the systemic arterial or venous pathways include deep vein thrombosis (DVT), pulmonary embolism (PE), stroke, intracardiac thrombus and myocardial infarction (MI)|within 13 months","within 4 months|within 13 months",{"$nulls":3},"Linz, Austria, 4020|Birmingham, Alabama, United States, 35233|Mesa, Arizona, United States, 85202|Charlotte, North Carolina, United States, 28204|Charlottesville, Virginia, United States, 22903|Seattle, Washington, United States, 98105","Alabama|Arizona|North Carolina|Virginia|Washington","Austria|United States","Kepler UniversitÃ¤tsklinikum Med Campus Iv|University Of Alabama At Birmingham|Cardon Childrens Medical Center|Novant Health Heart And Vascular Institute|University Of Virginia Health System|Seattle Children's Research Institute",{"$nulls":3},"Clinical Study Leader","2018-08-21","2020-05-25T16:36:10.636","2020-05-26T17:10:42.972","NCT03395639"]
["5ecbf3fbfeab101b15530847","NCT03395639","2018-09-28","Daiichi Sankyo","DSNKY","Recruiting","Edoxaban for Prevention of Blood Vessels Being Blocked by Clots (Thrombotic Events) in Children at Risk Because of Cardiac Disease","Edoxaban|Enoxaparin sodium|Heparin|Warfarin","FXa Inhibitor|AT III Activator|Thrombin Inhibitor|Heparin Inhibitor|Vitamin K Antagonist","No",null,"No",null,"Phase 3",2,150,"Anticipated","2017-11-16","2021-03-01",{"$nulls":5},"A committee will judge the safety and effectiveness of edoxaban and the regular treatment (standard of care).\n\nAll children in the study will receive free treatment. They will have a 2 in 3 chance to receive edoxaban, and a 1 in 3 chance to receive the standard of care for preventing blood clots.\n\nThe study will find out if edoxaban is safer and more effective than the standard of care.","The primary objective is to compare the safety of edoxaban with the standard of care (SOC) in pediatric subjects with cardiac diseases at risk of thromboembolic complications who need primary or secondary anticoagulant prophylaxis with regard to the combination of major and clinically relevant non-major (CRNM) bleeding per International Society on Thrombosis and Haemostasis [ISTH] definition.\n\nThe key secondary objective is to compare the efficacy of edoxaban against SOC with regard to the development of symptomatic thromboembolic events (TE) in the systemic arterial or venous pathways including deep vein thrombosis (DVT), pulmonary embolism (PE), stroke, intracardiac thrombus and myocardial infarction (MI), and asymptomatic intracardiac thrombus identified by cardiac imaging.","An Open-label, Randomised, Parallel-group, Multicentre, Observational Trial to Evaluate Safety and Efficacy of Edoxaban Tosylate in Children From 38 Weeks Gestational Age to Less Than 18 Years of Age With Cardiac Diseases at Risk of Thromboembolic Events","DU176b-C-U313","Cardiac Disease","Myocardial Infarction|Embolism|Pulmonary Embolism|Thrombosis|Stroke|Embolism and Thrombosis|Venous Thrombosis|Pulmonary Infarction","Heart Diseases|Vascular Diseases|Lung Diseases|Central Nervous System Diseases","Cardiovascular|Respiratory|Central Nervous System","Experimental|Active Comparator","Edoxaban|Standard of Care (SOC)","Two out of three participants will be randomized for treatment with edoxaban solution or tablets|One out of three participants will be randomized for treatment with the institution's SOC regimen","Drug","Edoxaban|Standard of Care (SOC)","Edoxaban 15 mg or 30 mg tablets for participants 12 to <18 years of age, or 60 mg edoxaban suspension (dosed as mg/kg) for participants under 12 years of age (and optionally, 12 or older), for oral administration|Standard of care could include low molecular weight heparin (LMWH) and/or VKA according to the clinical site's SOC treatment regimen","Lixiana | Savaysa|Warfarin/heparin | Enoxaparin","Edoxaban|Standard of Care (SOC)","\n\n * Is a child with cardiac disease who is at risk for thromboembolic complications and requires at least 3 months antithrombotic anticoagulant prophylaxis\n\nEither one of the following:\n\n 1. a child with cardiac disease who has a history of cardiac shunt occlusion/thrombosis, with shunt still in place (secondary prevention).OR\n    \n    \n 2. a child with cardiac disease who requires (including those already taking, and those not yet taking) anticoagulation for primary prevention of TE.\n\nCardiac conditions known to significantly increase the risk of thrombosis (hence, indications for primary TE prevention) are defined in Antithrombotic Therapy and Prevention of Thrombosis. Some examples of cardiac conditions at risk of thrombosis are Fontan surgery, heart failure, Kawasaki disease, and Blalock-Taussig and Glenn surgery.\n\n * Is a male or female child between 1 and <18 years of age (children between 38 weeks gestational age and 1 year of age will be included in the study, however, only after the safety and efficacy data of 50 subjects between 1 and <18 years of age in the edoxaban arm have been evaluated at the end of the 3-month treatment period)\n * Has parent(s)/legal guardian(s) or legally acceptable representative who is informed and provides signed consent for the child, to participate in the study with edoxaban treatment. Pediatric participants with appropriate intellectual maturity will be required to sign an assent form in addition to the signed informed consent from the parent(s)/legal guardian(s) or any legally acceptable representative.\n * If a female subject of childbearing potential, tests negative for pregnancy at Screening and consents to avoid becoming pregnant by using a locally approved contraception method throughout the study\n\n","\n\n * Has evidence of symptomatic venous or arterial thrombosis and/or asymptomatic intracardiac thrombosis confirmed by a transthoracic echocardiogram during study screening period\n * Has mechanical heart valve(s)\n * Has active bleeding or high risk of bleeding contraindicating treatment with anticoagulant\n * Takes antithrombotic therapy (other than low-dose aspirin) that is not protocol-related\n * Administration of rifampin is prohibited during the study and subjects on concomitant use of rifampin are excluded\n * Has any hepatic disease associated with coagulopathy leading to a clinically relevant bleeding risk\n * Has estimated glomerular filtration rate (eGFR) <30% of normal for age and size\n * Has stage 2 hypertension defined as blood pressure systolic and/or diastolic confirmed >99th percentile plus 5 mmHg\n * Has thrombocytopenia or life expectancy less than three months\n * Has had Fontan procedure with a history of or signs/symptoms suggestive of protein-losing enteropathy\n * Is pregnant or breastfeeding\n * Has a contraindication to the use of heparin and/or vitamin K antagonist (VKA)\n * Has any condition that, as judged by the Investigator, would place the participant at increased risk of harm if he/she participated in the study, including contraindicated medications identified in the protocol",{"$nulls":4},"Actual","2018-01-10","Actual","Anticipated","2021-03-01","Anticipated","2018-09-01","2018-01-04","2018-01-04","2018-09-26","Yes","Children\nPediatrics\nCardiac disease with potential for thromboembolic complications\nProphylactic treatment\nAnticoagulant drugs","Interventional","Prevention","Parallel Assignment","None (Open Label)","Randomized",null,"17 Years","All",null,"No","Yes\nDe-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://www.clinicalstudydatarequest.com//. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://www.clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-DS.aspx",{"$nulls":3},"Yes","No",{"$nulls":17},"2017-000475-90","EudraCT Number","Number of participants with combined bleeding events within the main treatment period|Number of participants with combined bleeding events during the entire trial (from first to the last dose plus 30 days)","Combined bleeding events include major and clinically-relevant non-major (CRNM) bleeding events per International Society on Thrombosis and Haemostasis (ISTH) definition occurring within the main treatment period|Combined bleeding events include major and clinically-relevant non-major (CRNM) bleeding events per International Society on Thrombosis and Haemostasis (ISTH) definition occurring on treatment","within 4 months (3-month Main Treatment Period + 30-day follow-up)|within 13 months (3-month Main Treatment Period + 9-month Extension Period + 30-day follow-up)","Number of participants with symptomatic thromboembolic events (TE) in the systemic arterial or venous pathways|Number of participants who died as a result of TE between randomization and the date of the last dose of study drug plus 30 days|Number of participants who died as a result of any cause between randomization and the date of the last dose of study drug plus 30 days","Symptomatic thromboembolic events (TE) in the systemic arterial or venous pathways include deep vein thrombosis (DVT), pulmonary embolism (PE), stroke, intracardiac thrombus and myocardial infarction (MI)|within 13 months","within 4 months|within 13 months",{"$nulls":3},"Linz, Austria, 4020|Birmingham, Alabama, United States, 35233|Mesa, Arizona, United States, 85202|Charlotte, North Carolina, United States, 28204|Charlottesville, Virginia, United States, 22903|Seattle, Washington, United States, 98105","Alabama|Arizona|North Carolina|Virginia|Washington","Austria|United States","Kepler UniversitÃ¤tsklinikum Med Campus Iv|University Of Alabama At Birmingham|Cardon Childrens Medical Center|Novant Health Heart And Vascular Institute|University Of Virginia Health System|Seattle Children's Research Institute",{"$nulls":3},"Clinical Study Leader","2018-09-26","2020-05-25T16:36:11.025","2020-05-26T17:10:42.972","NCT03395639"]
["5ecbf3fa307e3d1b1f8d9ca7","NCT03395639","2018-10-19","Daiichi Sankyo","DSNKY","Recruiting","Edoxaban for Prevention of Blood Vessels Being Blocked by Clots (Thrombotic Events) in Children at Risk Because of Cardiac Disease","Edoxaban|Enoxaparin sodium|Heparin|Warfarin","FXa Inhibitor|AT III Activator|Thrombin Inhibitor|Heparin Inhibitor|Vitamin K Antagonist","No",null,"No",null,"Phase 3",2,150,"Anticipated","2017-11-16","2021-03-01",{"$nulls":5},"A committee will judge the safety and effectiveness of edoxaban and the regular treatment (standard of care).\n\nAll children in the study will receive free treatment. They will have a 2 in 3 chance to receive edoxaban, and a 1 in 3 chance to receive the standard of care for preventing blood clots.\n\nThe study will find out if edoxaban is safer and more effective than the standard of care.","The primary objective is to compare the safety of edoxaban with the standard of care (SOC) in pediatric subjects with cardiac diseases at risk of thromboembolic complications who need primary or secondary anticoagulant prophylaxis with regard to the combination of major and clinically relevant non-major (CRNM) bleeding per International Society on Thrombosis and Haemostasis [ISTH] definition.\n\nThe key secondary objective is to compare the efficacy of edoxaban against SOC with regard to the development of symptomatic thromboembolic events (TE) in the systemic arterial or venous pathways including deep vein thrombosis (DVT), pulmonary embolism (PE), stroke, intracardiac thrombus and myocardial infarction (MI), and asymptomatic intracardiac thrombus identified by cardiac imaging.","An Open-label, Randomised, Parallel-group, Multicentre, Observational Trial to Evaluate Safety and Efficacy of Edoxaban Tosylate in Children From 38 Weeks Gestational Age to Less Than 18 Years of Age With Cardiac Diseases at Risk of Thromboembolic Events","DU176b-C-U313","Cardiac Disease","Myocardial Infarction|Embolism|Pulmonary Embolism|Thrombosis|Stroke|Embolism and Thrombosis|Venous Thrombosis|Pulmonary Infarction","Heart Diseases|Vascular Diseases|Lung Diseases|Central Nervous System Diseases","Cardiovascular|Respiratory|Central Nervous System","Experimental|Active Comparator","Edoxaban|Standard of Care (SOC)","Two out of three participants will be randomized for treatment with edoxaban solution or tablets|One out of three participants will be randomized for treatment with the institution's SOC regimen","Drug","Edoxaban|Standard of Care (SOC)","Edoxaban 15 mg or 30 mg tablets for participants 12 to <18 years of age, or 60 mg edoxaban suspension (dosed as mg/kg) for participants under 12 years of age (and optionally, 12 or older), for oral administration|Standard of care could include low molecular weight heparin (LMWH) and/or VKA according to the clinical site's SOC treatment regimen","Lixiana | Savaysa|Warfarin/heparin | Enoxaparin","Edoxaban|Standard of Care (SOC)","\n\n * Is a child with cardiac disease who is at risk for thromboembolic complications and requires at least 3 months antithrombotic anticoagulant prophylaxis\n\nEither one of the following:\n\n 1. a child with cardiac disease who has a history of cardiac shunt occlusion/thrombosis, with shunt still in place (secondary prevention).OR\n    \n    \n 2. a child with cardiac disease who requires (including those already taking, and those not yet taking) anticoagulation for primary prevention of TE.\n\nCardiac conditions known to significantly increase the risk of thrombosis (hence, indications for primary TE prevention) are defined in Antithrombotic Therapy and Prevention of Thrombosis. Some examples of cardiac conditions at risk of thrombosis are Fontan surgery, heart failure, Kawasaki disease, and Blalock-Taussig and Glenn surgery.\n\n * Is a male or female child between 1 and <18 years of age (children between 38 weeks gestational age and 1 year of age will be included in the study, however, only after the safety and efficacy data of 50 subjects between 1 and <18 years of age in the edoxaban arm have been evaluated at the end of the 3-month treatment period)\n * Has parent(s)/legal guardian(s) or legally acceptable representative who is informed and provides signed consent for the child, to participate in the study with edoxaban treatment. Pediatric participants with appropriate intellectual maturity will be required to sign an assent form in addition to the signed informed consent from the parent(s)/legal guardian(s) or any legally acceptable representative.\n * If a female subject of childbearing potential, tests negative for pregnancy at Screening and consents to avoid becoming pregnant by using a locally approved contraception method throughout the study\n\n","\n\n * Has evidence of symptomatic venous or arterial thrombosis and/or asymptomatic intracardiac thrombosis confirmed by a transthoracic echocardiogram during study screening period\n * Has mechanical heart valve(s)\n * Has active bleeding or high risk of bleeding contraindicating treatment with anticoagulant\n * Takes antithrombotic therapy (other than low-dose aspirin) that is not protocol-related\n * Administration of rifampin is prohibited during the study and subjects on concomitant use of rifampin are excluded\n * Has any hepatic disease associated with coagulopathy leading to a clinically relevant bleeding risk\n * Has estimated glomerular filtration rate (eGFR) <30% of normal for age and size\n * Has stage 2 hypertension defined as blood pressure systolic and/or diastolic confirmed >99th percentile plus 5 mmHg\n * Has thrombocytopenia or life expectancy less than three months\n * Has had Fontan procedure with a history of or signs/symptoms suggestive of protein-losing enteropathy\n * Is pregnant or breastfeeding\n * Has a contraindication to the use of heparin and/or vitamin K antagonist (VKA)\n * Has any condition that, as judged by the Investigator, would place the participant at increased risk of harm if he/she participated in the study, including contraindicated medications identified in the protocol",{"$nulls":4},"Actual","2018-01-10","Actual","Anticipated","2021-03-01","Anticipated","2018-10-01","2018-01-04","2018-01-04","2018-10-18","Yes","Children\nPediatrics\nCardiac disease with potential for thromboembolic complications\nProphylactic treatment\nAnticoagulant drugs","Interventional","Prevention","Parallel Assignment","None (Open Label)","Randomized",null,"17 Years","All",null,"No","Yes\nDe-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://www.clinicalstudydatarequest.com//. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://www.clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-DS.aspx",{"$nulls":3},"Yes","No",{"$nulls":17},"2017-000475-90","EudraCT Number","Number of participants with combined bleeding events within the main treatment period|Number of participants with combined bleeding events during the entire trial (from first to the last dose plus 30 days)","Combined bleeding events include major and clinically-relevant non-major (CRNM) bleeding events per International Society on Thrombosis and Haemostasis (ISTH) definition occurring within the main treatment period|Combined bleeding events include major and clinically-relevant non-major (CRNM) bleeding events per International Society on Thrombosis and Haemostasis (ISTH) definition occurring on treatment","within 4 months (3-month Main Treatment Period + 30-day follow-up)|within 13 months (3-month Main Treatment Period + 9-month Extension Period + 30-day follow-up)","Number of participants with symptomatic thromboembolic events (TE) in the systemic arterial or venous pathways|Number of participants who died as a result of TE between randomization and the date of the last dose of study drug plus 30 days|Number of participants who died as a result of any cause between randomization and the date of the last dose of study drug plus 30 days","Symptomatic thromboembolic events (TE) in the systemic arterial or venous pathways include deep vein thrombosis (DVT), pulmonary embolism (PE), stroke, intracardiac thrombus and myocardial infarction (MI)|within 13 months","within 4 months|within 13 months",{"$nulls":3},"Linz, Austria, 4020|Hamilton, Ontario, Canada, L8N 3Z5|Leicester, Leicestershire, United Kingdom, Le3 9Qp|Birmingham, Alabama, United States, 35233|Mesa, Arizona, United States, 85202|Charlotte, North Carolina, United States, 28204|Charlottesville, Virginia, United States, 22903|Seattle, Washington, United States, 98105","Alabama|Arizona|North Carolina|Virginia|Washington","Austria|Canada|United Kingdom|United States","Kepler UniversitÃ¤tsklinikum Med Campus Iv|Ontario Mcmaster Children's Hospital|, Leicestershire Glenfield Hospital|University Of Alabama At Birmingham|Cardon Childrens Medical Center|Novant Health Heart And Vascular Institute|University Of Virginia Health System|Seattle Children's Research Institute",{"$nulls":3},"Clinical Study Leader","2018-10-18","2020-05-25T16:36:10.653","2020-05-26T17:10:42.972","NCT03395639"]
["5ecbf3fb11702c1b1b916a28","NCT03395639","2018-11-20","Daiichi Sankyo","DSNKY","Recruiting","Edoxaban for Prevention of Blood Vessels Being Blocked by Clots (Thrombotic Events) in Children at Risk Because of Cardiac Disease","Edoxaban|Enoxaparin sodium|Heparin|Warfarin","FXa Inhibitor|AT III Activator|Thrombin Inhibitor|Heparin Inhibitor|Vitamin K Antagonist","No",null,"No",null,"Phase 3",2,150,"Anticipated","2017-11-16","2021-03-01",{"$nulls":5},"A committee will judge the safety and effectiveness of edoxaban and the regular treatment (standard of care).\n\nAll children in the study will receive free treatment. They will have a 2 in 3 chance to receive edoxaban, and a 1 in 3 chance to receive the standard of care for preventing blood clots.\n\nThe study will find out if edoxaban is safer and more effective than the standard of care.","The primary objective is to compare the safety of edoxaban with the standard of care (SOC) in pediatric subjects with cardiac diseases at risk of thromboembolic complications who need primary or secondary anticoagulant prophylaxis with regard to the combination of major and clinically relevant non-major (CRNM) bleeding per International Society on Thrombosis and Haemostasis [ISTH] definition.\n\nThe key secondary objective is to compare the efficacy of edoxaban against SOC with regard to the development of symptomatic thromboembolic events (TE) in the systemic arterial or venous pathways including deep vein thrombosis (DVT), pulmonary embolism (PE), stroke, intracardiac thrombus and myocardial infarction (MI), and asymptomatic intracardiac thrombus identified by cardiac imaging.","An Open-label, Randomised, Parallel-group, Multicentre, Observational Trial to Evaluate Safety and Efficacy of Edoxaban Tosylate in Children From 38 Weeks Gestational Age to Less Than 18 Years of Age With Cardiac Diseases at Risk of Thromboembolic Events","DU176b-C-U313","Cardiac Disease","Myocardial Infarction|Embolism|Pulmonary Embolism|Thrombosis|Stroke|Embolism and Thrombosis|Venous Thrombosis|Pulmonary Infarction","Heart Diseases|Vascular Diseases|Lung Diseases|Central Nervous System Diseases","Cardiovascular|Respiratory|Central Nervous System","Experimental|Active Comparator","Edoxaban|Standard of Care (SOC)","Two out of three participants will be randomized for treatment with edoxaban solution or tablets|One out of three participants will be randomized for treatment with the institution's SOC regimen","Drug","Edoxaban|Standard of Care (SOC)","Edoxaban 15 mg or 30 mg tablets for participants 12 to <18 years of age, or 60 mg edoxaban suspension (dosed as mg/kg) for participants under 12 years of age (and optionally, 12 or older), for oral administration|Standard of care could include low molecular weight heparin (LMWH) and/or VKA according to the clinical site's SOC treatment regimen","Lixiana | Savaysa|Warfarin/heparin | Enoxaparin","Edoxaban|Standard of Care (SOC)","\n\n * Is a child with cardiac disease who is at risk for thromboembolic complications and requires at least 3 months antithrombotic anticoagulant prophylaxis\n\nEither one of the following:\n\n 1. a child with cardiac disease who has a history of cardiac shunt occlusion/thrombosis, with shunt still in place (secondary prevention).OR\n    \n    \n 2. a child with cardiac disease who requires (including those already taking, and those not yet taking) anticoagulation for primary prevention of TE.\n\nCardiac conditions known to significantly increase the risk of thrombosis (hence, indications for primary TE prevention) are defined in Antithrombotic Therapy and Prevention of Thrombosis. Some examples of cardiac conditions at risk of thrombosis are Fontan surgery, heart failure, Kawasaki disease, and Blalock-Taussig and Glenn surgery.\n\n * Is a male or female child between 1 and <18 years of age (children between 38 weeks gestational age and 1 year of age will be included in the study, however, only after the safety and efficacy data of 50 subjects between 1 and <18 years of age in the edoxaban arm have been evaluated at the end of the 3-month treatment period)\n * Has parent(s)/legal guardian(s) or legally acceptable representative who is informed and provides signed consent for the child, to participate in the study with edoxaban treatment. Pediatric participants with appropriate intellectual maturity will be required to sign an assent form in addition to the signed informed consent from the parent(s)/legal guardian(s) or any legally acceptable representative.\n * If a female subject of childbearing potential, tests negative for pregnancy at Screening and consents to avoid becoming pregnant by using a locally approved contraception method throughout the study\n\n","\n\n * Has evidence of symptomatic venous or arterial thrombosis and/or asymptomatic intracardiac thrombosis confirmed by a transthoracic echocardiogram during study screening period\n * Has mechanical heart valve(s)\n * Has active bleeding or high risk of bleeding contraindicating treatment with anticoagulant\n * Takes antithrombotic therapy (other than low-dose aspirin) that is not protocol-related\n * Administration of rifampin is prohibited during the study and subjects on concomitant use of rifampin are excluded\n * Has any hepatic disease associated with coagulopathy leading to a clinically relevant bleeding risk\n * Has estimated glomerular filtration rate (eGFR) <30% of normal for age and size\n * Has stage 2 hypertension defined as blood pressure systolic and/or diastolic confirmed >99th percentile plus 5 mmHg\n * Has thrombocytopenia or life expectancy less than three months\n * Has had Fontan procedure with a history of or signs/symptoms suggestive of protein-losing enteropathy\n * Is pregnant or breastfeeding\n * Has a contraindication to the use of heparin and/or vitamin K antagonist (VKA)\n * Has any condition that, as judged by the Investigator, would place the participant at increased risk of harm if he/she participated in the study, including contraindicated medications identified in the protocol",{"$nulls":4},"Actual","2018-01-10","Actual","Anticipated","2021-03-01","Anticipated","2018-11-01","2018-01-04","2018-01-04","2018-11-19","Yes","Children\nPediatrics\nCardiac disease with potential for thromboembolic complications\nProphylactic treatment\nAnticoagulant drugs","Interventional","Prevention","Parallel Assignment","None (Open Label)","Randomized",null,"17 Years","All",null,"No","Yes\nDe-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://www.clinicalstudydatarequest.com//. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://www.clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-DS.aspx",{"$nulls":3},"Yes","No",{"$nulls":17},"2017-000475-90","EudraCT Number","Number of participants with combined bleeding events within the main treatment period|Number of participants with combined bleeding events during the entire trial (from first to the last dose plus 30 days)","Combined bleeding events include major and clinically-relevant non-major (CRNM) bleeding events per International Society on Thrombosis and Haemostasis (ISTH) definition occurring within the main treatment period|Combined bleeding events include major and clinically-relevant non-major (CRNM) bleeding events per International Society on Thrombosis and Haemostasis (ISTH) definition occurring on treatment","within 4 months (3-month Main Treatment Period + 30-day follow-up)|within 13 months (3-month Main Treatment Period + 9-month Extension Period + 30-day follow-up)","Number of participants with symptomatic thromboembolic events (TE) in the systemic arterial or venous pathways|Number of participants who died as a result of TE between randomization and the date of the last dose of study drug plus 30 days|Number of participants who died as a result of any cause between randomization and the date of the last dose of study drug plus 30 days","Symptomatic thromboembolic events (TE) in the systemic arterial or venous pathways include deep vein thrombosis (DVT), pulmonary embolism (PE), stroke, intracardiac thrombus and myocardial infarction (MI)|within 13 months","within 4 months|within 13 months",{"$nulls":3},"Linz, Austria, 4020|Hamilton, Ontario, Canada, L8N 3Z5|Barcelona, Spain, 08035|London, Greater London, United Kingdom, Sw3 6Hp|Leicester, Leicestershire, United Kingdom, Le3 9Qp|Glasgow, Strathclyde, United Kingdom, G51 4Tf|Birmingham, Alabama, United States, 35233|Mesa, Arizona, United States, 85202|Charlotte, North Carolina, United States, 28204|Charlottesville, Virginia, United States, 22903|Seattle, Washington, United States, 98105","Alabama|Arizona|North Carolina|Virginia|Washington","Austria|Canada|Spain|United Kingdom|United States","Kepler UniversitÃ¤tsklinikum Med Campus Iv|Ontario Mcmaster Children's Hospital|Hospital Universitari Vall D'Hebron|, Greater London Royal Brompton Hospital|, Leicestershire Glenfield Hospital|, Strathclyde Ward 2B, Royal Hospital For Children|University Of Alabama At Birmingham|Cardon Childrens Medical Center|Novant Health Heart And Vascular Institute|University Of Virginia Health System|Seattle Children's Research Institute",{"$nulls":3},"Clinical Study Leader","2018-11-19","2020-05-25T16:36:11.002","2020-05-26T17:10:42.972","NCT03395639"]
["5ecbf3fae2561b1b11905d12","NCT03395639","2018-12-21","Daiichi Sankyo","DSNKY","Recruiting","Edoxaban for Prevention of Blood Vessels Being Blocked by Clots (Thrombotic Events) in Children at Risk Because of Cardiac Disease","Edoxaban|Enoxaparin sodium|Heparin|Warfarin","FXa Inhibitor|AT III Activator|Thrombin Inhibitor|Heparin Inhibitor|Vitamin K Antagonist","No",null,"No",null,"Phase 3",2,150,"Anticipated","2017-11-16","2021-03-01",{"$nulls":5},"A committee will judge the safety and effectiveness of edoxaban and the regular treatment (standard of care).\n\nAll children in the study will receive free treatment. They will have a 2 in 3 chance to receive edoxaban, and a 1 in 3 chance to receive the standard of care for preventing blood clots.\n\nThe study will find out if edoxaban is safer and more effective than the standard of care.","The primary objective is to compare the safety of edoxaban with the standard of care (SOC) in pediatric subjects with cardiac diseases at risk of thromboembolic complications who need primary or secondary anticoagulant prophylaxis with regard to the combination of major and clinically relevant non-major (CRNM) bleeding per International Society on Thrombosis and Haemostasis [ISTH] definition.\n\nThe key secondary objective is to compare the efficacy of edoxaban against SOC with regard to the development of symptomatic thromboembolic events (TE) in the systemic arterial or venous pathways including deep vein thrombosis (DVT), pulmonary embolism (PE), stroke, intracardiac thrombus and myocardial infarction (MI), and asymptomatic intracardiac thrombus identified by cardiac imaging.","An Open-label, Randomised, Parallel-group, Multicentre, Observational Trial to Evaluate Safety and Efficacy of Edoxaban Tosylate in Children From 38 Weeks Gestational Age to Less Than 18 Years of Age With Cardiac Diseases at Risk of Thromboembolic Events","DU176b-C-U313","Cardiac Disease","Myocardial Infarction|Embolism|Pulmonary Embolism|Thrombosis|Stroke|Embolism and Thrombosis|Venous Thrombosis|Pulmonary Infarction","Heart Diseases|Vascular Diseases|Lung Diseases|Central Nervous System Diseases","Cardiovascular|Respiratory|Central Nervous System","Experimental|Active Comparator","Edoxaban|Standard of Care (SOC)","Two out of three participants will be randomized for treatment with edoxaban solution or tablets|One out of three participants will be randomized for treatment with the institution's SOC regimen","Drug","Edoxaban|Standard of Care (SOC)","Edoxaban 15 mg or 30 mg tablets for participants 12 to <18 years of age, or 60 mg edoxaban suspension (dosed as mg/kg) for participants under 12 years of age (and optionally, 12 or older), for oral administration|Standard of care could include low molecular weight heparin (LMWH) and/or VKA according to the clinical site's SOC treatment regimen","Lixiana | Savaysa|Warfarin/heparin | Enoxaparin","Edoxaban|Standard of Care (SOC)","\n\n * Is a child with cardiac disease who is at risk for thromboembolic complications and requires at least 3 months antithrombotic anticoagulant prophylaxis\n\nEither one of the following:\n\n 1. a child with cardiac disease who has a history of cardiac shunt occlusion/thrombosis, with shunt still in place (secondary prevention).OR\n    \n    \n 2. a child with cardiac disease who requires (including those already taking, and those not yet taking) anticoagulation for primary prevention of TE.\n\nCardiac conditions known to significantly increase the risk of thrombosis (hence, indications for primary TE prevention) are defined in Antithrombotic Therapy and Prevention of Thrombosis. Some examples of cardiac conditions at risk of thrombosis are Fontan surgery, heart failure, Kawasaki disease, and Blalock-Taussig and Glenn surgery.\n\n * Is a male or female child between 1 and <18 years of age (children between 38 weeks gestational age and 1 year of age will be included in the study, however, only after the safety and efficacy data of 50 subjects between 1 and <18 years of age in the edoxaban arm have been evaluated at the end of the 3-month treatment period)\n * Has parent(s)/legal guardian(s) or legally acceptable representative who is informed and provides signed consent for the child, to participate in the study with edoxaban treatment. Pediatric participants with appropriate intellectual maturity will be required to sign an assent form in addition to the signed informed consent from the parent(s)/legal guardian(s) or any legally acceptable representative.\n * If a female subject of childbearing potential, tests negative for pregnancy at Screening and consents to avoid becoming pregnant by using a locally approved contraception method throughout the study\n\n","\n\n * Has evidence of symptomatic venous or arterial thrombosis and/or asymptomatic intracardiac thrombosis confirmed by a transthoracic echocardiogram during study screening period\n * Has mechanical heart valve(s)\n * Has active bleeding or high risk of bleeding contraindicating treatment with anticoagulant\n * Takes antithrombotic therapy (other than low-dose aspirin) that is not protocol-related\n * Administration of rifampin is prohibited during the study and subjects on concomitant use of rifampin are excluded\n * Has any hepatic disease associated with coagulopathy leading to a clinically relevant bleeding risk\n * Has estimated glomerular filtration rate (eGFR) <30% of normal for age and size\n * Has stage 2 hypertension defined as blood pressure systolic and/or diastolic confirmed >99th percentile plus 5 mmHg\n * Has thrombocytopenia or life expectancy less than three months\n * Has had Fontan procedure with a history of or signs/symptoms suggestive of protein-losing enteropathy\n * Is pregnant or breastfeeding\n * Has a contraindication to the use of heparin and/or vitamin K antagonist (VKA)\n * Has any condition that, as judged by the Investigator, would place the participant at increased risk of harm if he/she participated in the study, including contraindicated medications identified in the protocol",{"$nulls":4},"Actual","2018-01-10","Actual","Anticipated","2021-03-01","Anticipated","2018-11-01","2018-01-04","2018-01-04","2018-12-19","Yes","Children\nPediatrics\nCardiac disease with potential for thromboembolic complications\nProphylactic treatment\nAnticoagulant drugs","Interventional","Prevention","Parallel Assignment","None (Open Label)","Randomized",null,"17 Years","All",null,"No","Yes\nDe-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/",{"$nulls":3},"Yes","No",{"$nulls":17},"2017-000475-90","EudraCT Number","Number of participants with combined bleeding events within the main treatment period|Number of participants with combined bleeding events during the entire trial (from first to the last dose plus 30 days)","Combined bleeding events include major and clinically-relevant non-major (CRNM) bleeding events per International Society on Thrombosis and Haemostasis (ISTH) definition occurring within the main treatment period|Combined bleeding events include major and clinically-relevant non-major (CRNM) bleeding events per International Society on Thrombosis and Haemostasis (ISTH) definition occurring on treatment","within 4 months (3-month Main Treatment Period + 30-day follow-up)|within 13 months (3-month Main Treatment Period + 9-month Extension Period + 30-day follow-up)","Number of participants with symptomatic thromboembolic events (TE) in the systemic arterial or venous pathways|Number of participants who died as a result of TE between randomization and the date of the last dose of study drug plus 30 days|Number of participants who died as a result of any cause between randomization and the date of the last dose of study drug plus 30 days","Symptomatic thromboembolic events (TE) in the systemic arterial or venous pathways include deep vein thrombosis (DVT), pulmonary embolism (PE), stroke, intracardiac thrombus and myocardial infarction (MI)|within 13 months","within 4 months|within 13 months",{"$nulls":3},"Linz, Austria, 4020|Hamilton, Ontario, Canada, L8N 3Z5|Barcelona, Spain, 08035|London, Greater London, United Kingdom, Sw3 6Hp|Leicester, Leicestershire, United Kingdom, Le3 9Qp|Glasgow, Strathclyde, United Kingdom, G51 4Tf|Birmingham, Alabama, United States, 35233|Mesa, Arizona, United States, 85202|Charlotte, North Carolina, United States, 28204|Charlottesville, Virginia, United States, 22903|Seattle, Washington, United States, 98105","Alabama|Arizona|North Carolina|Virginia|Washington","Austria|Canada|Spain|United Kingdom|United States","Kepler UniversitÃ¤tsklinikum Med Campus Iv|Ontario Mcmaster Children's Hospital|Hospital Universitari Vall D'Hebron|, Greater London Royal Brompton Hospital|, Leicestershire Glenfield Hospital|, Strathclyde Ward 2B, Royal Hospital For Children|University Of Alabama At Birmingham|Cardon Childrens Medical Center|Novant Health Heart And Vascular Institute|University Of Virginia Health System|Seattle Children's Research Institute",{"$nulls":3},"Clinical Study Leader","2018-12-19","2020-05-25T16:36:10.855","2020-05-26T17:10:42.972","NCT03395639"]
["5ecbf3fbfeab101b15530848","NCT03395639","2019-01-22","Daiichi Sankyo","DSNKY","Recruiting","Edoxaban for Prevention of Blood Vessels Being Blocked by Clots (Thrombotic Events) in Children at Risk Because of Cardiac Disease","Edoxaban|Enoxaparin sodium|Heparin|Warfarin","FXa Inhibitor|AT III Activator|Thrombin Inhibitor|Heparin Inhibitor|Vitamin K Antagonist","No",null,"No",null,"Phase 3",2,150,"Anticipated","2017-11-16","2021-03-01",{"$nulls":5},"A committee will judge the safety and effectiveness of edoxaban and the regular treatment (standard of care).\n\nAll children in the study will receive free treatment. They will have a 2 in 3 chance to receive edoxaban, and a 1 in 3 chance to receive the standard of care for preventing blood clots.\n\nThe study will find out if edoxaban is safer and more effective than the standard of care.","The primary objective is to compare the safety of edoxaban with the standard of care (SOC) in pediatric subjects with cardiac diseases at risk of thromboembolic complications who need primary or secondary anticoagulant prophylaxis with regard to the combination of major and clinically relevant non-major (CRNM) bleeding per International Society on Thrombosis and Haemostasis [ISTH] definition.\n\nThe key secondary objective is to compare the efficacy of edoxaban against SOC with regard to the development of symptomatic thromboembolic events (TE) in the systemic arterial or venous pathways including deep vein thrombosis (DVT), pulmonary embolism (PE), stroke, intracardiac thrombus and myocardial infarction (MI), and asymptomatic intracardiac thrombus identified by cardiac imaging.","An Open-label, Randomised, Parallel-group, Multicentre, Observational Trial to Evaluate Safety and Efficacy of Edoxaban Tosylate in Children From 38 Weeks Gestational Age to Less Than 18 Years of Age With Cardiac Diseases at Risk of Thromboembolic Events","DU176b-C-U313","Cardiac Disease","Myocardial Infarction|Embolism|Pulmonary Embolism|Thrombosis|Stroke|Embolism and Thrombosis|Venous Thrombosis|Pulmonary Infarction","Heart Diseases|Vascular Diseases|Lung Diseases|Central Nervous System Diseases","Cardiovascular|Respiratory|Central Nervous System","Experimental|Active Comparator","Edoxaban|Standard of Care (SOC)","Two out of three participants will be randomized for treatment with edoxaban solution or tablets|One out of three participants will be randomized for treatment with the institution's SOC regimen","Drug","Edoxaban|Standard of Care (SOC)","Edoxaban 15 mg or 30 mg tablets for participants 12 to <18 years of age, or 60 mg edoxaban suspension (dosed as mg/kg) for participants under 12 years of age (and optionally, 12 or older), for oral administration|Standard of care could include low molecular weight heparin (LMWH) and/or VKA according to the clinical site's SOC treatment regimen","Lixiana | Savaysa|Warfarin/heparin | Enoxaparin","Edoxaban|Standard of Care (SOC)","\n\n * Is a child with cardiac disease who is at risk for thromboembolic complications and requires at least 3 months antithrombotic anticoagulant prophylaxis\n\nEither one of the following:\n\n 1. a child with cardiac disease who has a history of cardiac shunt occlusion/thrombosis, with shunt still in place (secondary prevention).OR\n    \n    \n 2. a child with cardiac disease who requires (including those already taking, and those not yet taking) anticoagulation for primary prevention of TE.\n\nCardiac conditions known to significantly increase the risk of thrombosis (hence, indications for primary TE prevention) are defined in Antithrombotic Therapy and Prevention of Thrombosis. Some examples of cardiac conditions at risk of thrombosis are Fontan surgery, heart failure, Kawasaki disease, and Blalock-Taussig and Glenn surgery.\n\n * Is a male or female child between 1 and <18 years of age (children between 38 weeks gestational age and 1 year of age will be included in the study, however, only after the safety and efficacy data of 50 subjects between 1 and <18 years of age in the edoxaban arm have been evaluated at the end of the 3-month treatment period)\n * Has parent(s)/legal guardian(s) or legally acceptable representative who is informed and provides signed consent for the child, to participate in the study with edoxaban treatment. Pediatric participants with appropriate intellectual maturity will be required to sign an assent form in addition to the signed informed consent from the parent(s)/legal guardian(s) or any legally acceptable representative.\n * If a female subject of childbearing potential, tests negative for pregnancy at Screening and consents to avoid becoming pregnant by using a locally approved contraception method throughout the study\n\n","\n\n * Has evidence of symptomatic venous or arterial thrombosis and/or asymptomatic intracardiac thrombosis confirmed by a transthoracic echocardiogram during study screening period\n * Has mechanical heart valve(s)\n * Has active bleeding or high risk of bleeding contraindicating treatment with anticoagulant\n * Takes antithrombotic therapy (other than low-dose aspirin) that is not protocol-related\n * Administration of rifampin is prohibited during the study and subjects on concomitant use of rifampin are excluded\n * Has any hepatic disease associated with coagulopathy leading to a clinically relevant bleeding risk\n * Has estimated glomerular filtration rate (eGFR) <30% of normal for age and size\n * Has stage 2 hypertension defined as blood pressure systolic and/or diastolic confirmed >99th percentile plus 5 mmHg\n * Has thrombocytopenia or life expectancy less than three months\n * Has had Fontan procedure with a history of or signs/symptoms suggestive of protein-losing enteropathy\n * Is pregnant or breastfeeding\n * Has a contraindication to the use of heparin and/or vitamin K antagonist (VKA)\n * Has any condition that, as judged by the Investigator, would place the participant at increased risk of harm if he/she participated in the study, including contraindicated medications identified in the protocol",{"$nulls":4},"Actual","2018-01-10","Actual","Anticipated","2021-03-01","Anticipated","2019-01-01","2018-01-04","2018-01-04","2019-01-18","Yes","Children\nPediatrics\nCardiac disease with potential for thromboembolic complications\nProphylactic treatment\nAnticoagulant drugs","Interventional","Prevention","Parallel Assignment","None (Open Label)","Randomized",null,"17 Years","All",null,"No","Yes\nDe-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/",{"$nulls":3},"Yes","No",{"$nulls":17},"2017-000475-90","EudraCT Number","Number of participants with combined bleeding events within the main treatment period|Number of participants with combined bleeding events during the entire trial (from first to the last dose plus 30 days)","Combined bleeding events include major and clinically-relevant non-major (CRNM) bleeding events per International Society on Thrombosis and Haemostasis (ISTH) definition occurring within the main treatment period|Combined bleeding events include major and clinically-relevant non-major (CRNM) bleeding events per International Society on Thrombosis and Haemostasis (ISTH) definition occurring on treatment","within 4 months (3-month Main Treatment Period + 30-day follow-up)|within 13 months (3-month Main Treatment Period + 9-month Extension Period + 30-day follow-up)","Number of participants with symptomatic thromboembolic events (TE) in the systemic arterial or venous pathways|Number of participants who died as a result of TE between randomization and the date of the last dose of study drug plus 30 days|Number of participants who died as a result of any cause between randomization and the date of the last dose of study drug plus 30 days","Symptomatic thromboembolic events (TE) in the systemic arterial or venous pathways include deep vein thrombosis (DVT), pulmonary embolism (PE), stroke, intracardiac thrombus and myocardial infarction (MI)|within 13 months","within 4 months|within 13 months",{"$nulls":3},"Linz, Austria, 4020|Hamilton, Ontario, Canada, L8N 3Z5|Zagreb, Croatia, 10000|Zagazig, Al Sharkeya, Egypt, 44519|Alexandria, Egypt, 21131|Be'Er Sheva, Israel, 8410101|Barcelona, Spain, 08035|London, Greater London, United Kingdom, Sw3 6Hp|Leicester, Leicestershire, United Kingdom, Le3 9Qp|Glasgow, Strathclyde, United Kingdom, G51 4Tf|Birmingham, Alabama, United States, 35233|Mesa, Arizona, United States, 85202|Charlotte, North Carolina, United States, 28204|Charlottesville, Virginia, United States, 22903|Seattle, Washington, United States, 98105","Alabama|Arizona|North Carolina|Virginia|Washington","Austria|Canada|Croatia|Egypt|Israel|Spain|United Kingdom|United States","Kepler UniversitÃ¤tsklinikum Med Campus Iv|Ontario Mcmaster Children's Hospital|University Hospital Center Zagreb|Al Sharkeya Zagazig University Hospital|Alexandria Clinical Research Center, Faculty Of Medicine|Soroka University Medical Center|Hospital Universitari Vall D'Hebron|, Greater London Royal Brompton Hospital|, Leicestershire Glenfield Hospital|, Strathclyde Ward 2B, Royal Hospital For Children|University Of Alabama At Birmingham|Cardon Childrens Medical Center|Novant Health Heart And Vascular Institute|University Of Virginia Health System|Seattle Children's Research Institute",{"$nulls":3},"Clinical Study Leader","2019-01-18","2020-05-25T16:36:11.391","2020-05-26T17:10:42.972","NCT03395639"]
["5ecbf3fafe30261b1a048217","NCT03395639","2019-02-12","Daiichi Sankyo","DSNKY","Recruiting","Edoxaban for Prevention of Blood Vessels Being Blocked by Clots (Thrombotic Events) in Children at Risk Because of Cardiac Disease","Edoxaban|Enoxaparin sodium|Heparin|Warfarin","FXa Inhibitor|AT III Activator|Thrombin Inhibitor|Heparin Inhibitor|Vitamin K Antagonist","No",null,"No",null,"Phase 3",2,150,"Anticipated","2017-11-16","2021-03-01",{"$nulls":5},"A committee will judge the safety and effectiveness of edoxaban and the regular treatment (standard of care).\n\nAll children in the study will receive free treatment. They will have a 2 in 3 chance to receive edoxaban, and a 1 in 3 chance to receive the standard of care for preventing blood clots.\n\nThe study will find out if edoxaban is safer and more effective than the standard of care.","The primary objective is to compare the safety of edoxaban with the standard of care (SOC) in pediatric subjects with cardiac diseases at risk of thromboembolic complications who need primary or secondary anticoagulant prophylaxis with regard to the combination of major and clinically relevant non-major (CRNM) bleeding per International Society on Thrombosis and Haemostasis [ISTH] definition.\n\nThe key secondary objective is to compare the efficacy of edoxaban against SOC with regard to the development of symptomatic thromboembolic events (TE) in the systemic arterial or venous pathways including deep vein thrombosis (DVT), pulmonary embolism (PE), stroke, intracardiac thrombus and myocardial infarction (MI), and asymptomatic intracardiac thrombus identified by cardiac imaging.","An Open-label, Randomised, Parallel-group, Multicentre, Observational Trial to Evaluate Safety and Efficacy of Edoxaban Tosylate in Children From 38 Weeks Gestational Age to Less Than 18 Years of Age With Cardiac Diseases at Risk of Thromboembolic Events","DU176b-C-U313","Cardiac Disease","Myocardial Infarction|Embolism|Pulmonary Embolism|Thrombosis|Stroke|Embolism and Thrombosis|Venous Thrombosis|Pulmonary Infarction","Heart Diseases|Vascular Diseases|Lung Diseases|Central Nervous System Diseases","Cardiovascular|Respiratory|Central Nervous System","Experimental|Active Comparator","Edoxaban|Standard of Care (SOC)","Two out of three participants will be randomized for treatment with edoxaban solution or tablets|One out of three participants will be randomized for treatment with the institution's SOC regimen","Drug","Edoxaban|Standard of Care (SOC)","Edoxaban 15 mg or 30 mg tablets for participants 12 to <18 years of age, or 60 mg edoxaban suspension (dosed as mg/kg) for participants under 12 years of age (and optionally, 12 or older), for oral administration|Standard of care could include low molecular weight heparin (LMWH) and/or VKA according to the clinical site's SOC treatment regimen","Lixiana | Savaysa|Warfarin/heparin | Enoxaparin","Edoxaban|Standard of Care (SOC)","\n\n * Is a child with cardiac disease who is at risk for thromboembolic complications and requires at least 3 months antithrombotic anticoagulant prophylaxis\n\nEither one of the following:\n\n 1. a child with cardiac disease who has a history of cardiac shunt occlusion/thrombosis, with shunt still in place (secondary prevention).OR\n    \n    \n 2. a child with cardiac disease who requires (including those already taking, and those not yet taking) anticoagulation for primary prevention of TE.\n\nCardiac conditions known to significantly increase the risk of thrombosis (hence, indications for primary TE prevention) are defined in Antithrombotic Therapy and Prevention of Thrombosis. Some examples of cardiac conditions at risk of thrombosis are Fontan surgery, heart failure, Kawasaki disease, and Blalock-Taussig and Glenn surgery.\n\n * Is a male or female child between 1 and <18 years of age (children between 38 weeks gestational age and 1 year of age will be included in the study, however, only after the safety and efficacy data of 50 subjects between 1 and <18 years of age in the edoxaban arm have been evaluated at the end of the 3-month treatment period)\n * Has parent(s)/legal guardian(s) or legally acceptable representative who is informed and provides signed consent for the child, to participate in the study with edoxaban treatment. Pediatric participants with appropriate intellectual maturity will be required to sign an assent form in addition to the signed informed consent from the parent(s)/legal guardian(s) or any legally acceptable representative.\n * If a female subject of childbearing potential, tests negative for pregnancy at Screening and consents to avoid becoming pregnant by using a locally approved contraception method throughout the study\n\n","\n\n * Has evidence of symptomatic venous or arterial thrombosis and/or asymptomatic intracardiac thrombosis confirmed by a transthoracic echocardiogram during study screening period\n * Has mechanical heart valve(s)\n * Has active bleeding or high risk of bleeding contraindicating treatment with anticoagulant\n * Takes antithrombotic therapy (other than low-dose aspirin) that is not protocol-related\n * Administration of rifampin is prohibited during the study and subjects on concomitant use of rifampin are excluded\n * Has any hepatic disease associated with coagulopathy leading to a clinically relevant bleeding risk\n * Has estimated glomerular filtration rate (eGFR) <30% of normal for age and size\n * Has stage 2 hypertension defined as blood pressure systolic and/or diastolic confirmed >99th percentile plus 5 mmHg\n * Has thrombocytopenia or life expectancy less than three months\n * Has had Fontan procedure with a history of or signs/symptoms suggestive of protein-losing enteropathy\n * Is pregnant or breastfeeding\n * Has a contraindication to the use of heparin and/or vitamin K antagonist (VKA)\n * Has any condition that, as judged by the Investigator, would place the participant at increased risk of harm if he/she participated in the study, including contraindicated medications identified in the protocol",{"$nulls":4},"Actual","2018-01-10","Actual","Anticipated","2021-03-01","Anticipated","2019-01-01","2018-01-04","2018-01-04","2019-02-08","Yes","Children\nPediatrics\nCardiac disease with potential for thromboembolic complications\nProphylactic treatment\nAnticoagulant drugs","Interventional","Prevention","Parallel Assignment","None (Open Label)","Randomized",null,"17 Years","All",null,"No","Yes\nDe-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/",{"$nulls":3},"Yes","No",{"$nulls":17},"2017-000475-90","EudraCT Number","Number of participants with combined bleeding events within the main treatment period|Number of participants with combined bleeding events during the entire trial (from first to the last dose plus 30 days)","Combined bleeding events include major and clinically-relevant non-major (CRNM) bleeding events per International Society on Thrombosis and Haemostasis (ISTH) definition occurring within the main treatment period|Combined bleeding events include major and clinically-relevant non-major (CRNM) bleeding events per International Society on Thrombosis and Haemostasis (ISTH) definition occurring on treatment","within 4 months (3-month Main Treatment Period + 30-day follow-up)|within 13 months (3-month Main Treatment Period + 9-month Extension Period + 30-day follow-up)","Number of participants with symptomatic thromboembolic events (TE) in the systemic arterial or venous pathways|Number of participants who died as a result of TE between randomization and the date of the last dose of study drug plus 30 days|Number of participants who died as a result of any cause between randomization and the date of the last dose of study drug plus 30 days","Symptomatic thromboembolic events (TE) in the systemic arterial or venous pathways include deep vein thrombosis (DVT), pulmonary embolism (PE), stroke, intracardiac thrombus and myocardial infarction (MI)|within 13 months","within 4 months|within 13 months",{"$nulls":3},"Linz, Austria, 4020|Hamilton, Ontario, Canada, L8N 3Z5|Zagreb, Croatia, 10000|Zagazig, Al Sharkeya, Egypt, 44519|Alexandria, Egypt, 21131|Be'Er Sheva, Israel, 8410101|Barcelona, Spain, 08035|London, Greater London, United Kingdom, Sw3 6Hp|Leicester, Leicestershire, United Kingdom, Le3 9Qp|Glasgow, Strathclyde, United Kingdom, G51 4Tf|Birmingham, Alabama, United States, 35233|Mesa, Arizona, United States, 85202|Charlotte, North Carolina, United States, 28204|Charlottesville, Virginia, United States, 22903|Seattle, Washington, United States, 98105","Alabama|Arizona|North Carolina|Virginia|Washington","Austria|Canada|Croatia|Egypt|Israel|Spain|United Kingdom|United States","Kepler UniversitÃ¤tsklinikum Med Campus Iv|Ontario Mcmaster Children's Hospital|University Hospital Center Zagreb|Al Sharkeya Zagazig University Hospital|Alexandria Clinical Research Center, Faculty Of Medicine|Soroka University Medical Center|Hospital Universitari Vall D'Hebron|, Greater London Royal Brompton Hospital|, Leicestershire Glenfield Hospital|, Strathclyde Ward 2B, Royal Hospital For Children|University Of Alabama At Birmingham|Cardon Childrens Medical Center|Novant Health Heart And Vascular Institute|University Of Virginia Health System|Seattle Children's Research Institute",{"$nulls":3},"Clinical Study Leader","2019-02-08","2020-05-25T16:36:10.899","2020-05-26T17:10:42.972","NCT03395639"]
["5ecbf3fbe2561b1b11905d13","NCT03395639","2019-02-22","Daiichi Sankyo","DSNKY","Recruiting","Edoxaban for Prevention of Blood Vessels Being Blocked by Clots (Thrombotic Events) in Children at Risk Because of Cardiac Disease","Edoxaban|Enoxaparin sodium|Heparin|Warfarin","FXa Inhibitor|AT III Activator|Thrombin Inhibitor|Heparin Inhibitor|Vitamin K Antagonist","No",null,"No",null,"Phase 3",2,150,"Anticipated","2017-11-16","2021-03-01",{"$nulls":5},"A committee will judge the safety and effectiveness of edoxaban and the regular treatment (standard of care).\n\nAll children in the study will receive free treatment. They will have a 2 in 3 chance to receive edoxaban, and a 1 in 3 chance to receive the standard of care for preventing blood clots.\n\nThe study will find out if edoxaban is safer and more effective than the standard of care.","The primary objective is to compare the safety of edoxaban with the standard of care (SOC) in pediatric subjects with cardiac diseases at risk of thromboembolic complications who need primary or secondary anticoagulant prophylaxis with regard to the combination of major and clinically relevant non-major (CRNM) bleeding per International Society on Thrombosis and Haemostasis [ISTH] definition.\n\nThe key secondary objective is to compare the efficacy of edoxaban against SOC with regard to the development of symptomatic thromboembolic events (TE) in the systemic arterial or venous pathways including deep vein thrombosis (DVT), pulmonary embolism (PE), stroke, intracardiac thrombus and myocardial infarction (MI), and asymptomatic intracardiac thrombus identified by cardiac imaging.","An Open-label, Randomised, Parallel-group, Multicentre, Observational Trial to Evaluate Safety and Efficacy of Edoxaban Tosylate in Children From 38 Weeks Gestational Age to Less Than 18 Years of Age With Cardiac Diseases at Risk of Thromboembolic Events","DU176b-C-U313","Cardiac Disease","Myocardial Infarction|Embolism|Pulmonary Embolism|Thrombosis|Stroke|Embolism and Thrombosis|Venous Thrombosis|Pulmonary Infarction","Heart Diseases|Vascular Diseases|Lung Diseases|Central Nervous System Diseases","Cardiovascular|Respiratory|Central Nervous System","Experimental|Active Comparator","Edoxaban|Standard of Care (SOC)","Two out of three participants will be randomized for treatment with edoxaban solution or tablets|One out of three participants will be randomized for treatment with the institution's SOC regimen","Drug","Edoxaban|Standard of Care (SOC)","Edoxaban 15 mg or 30 mg tablets for participants 12 to <18 years of age, or 60 mg edoxaban suspension (dosed as mg/kg) for participants under 12 years of age (and optionally, 12 or older), for oral administration|Standard of care could include low molecular weight heparin (LMWH) and/or VKA according to the clinical site's SOC treatment regimen","Lixiana | Savaysa|Warfarin/heparin | Enoxaparin","Edoxaban|Standard of Care (SOC)","\n\n * Is a child with cardiac disease who is at risk for thromboembolic complications and requires at least 3 months antithrombotic anticoagulant prophylaxis\n\nEither one of the following:\n\n 1. a child with cardiac disease who has a history of cardiac shunt occlusion/thrombosis, with shunt still in place (secondary prevention).OR\n    \n    \n 2. a child with cardiac disease who requires (including those already taking, and those not yet taking) anticoagulation for primary prevention of TE.\n\nCardiac conditions known to significantly increase the risk of thrombosis (hence, indications for primary TE prevention) are defined in Antithrombotic Therapy and Prevention of Thrombosis. Some examples of cardiac conditions at risk of thrombosis are Fontan surgery, heart failure, Kawasaki disease, and Blalock-Taussig and Glenn surgery.\n\n * Is a male or female child between 1 and <18 years of age (children between 38 weeks gestational age and 1 year of age will be included in the study, however, only after the safety and efficacy data of 50 subjects between 1 and <18 years of age in the edoxaban arm have been evaluated at the end of the 3-month treatment period)\n * Has parent(s)/legal guardian(s) or legally acceptable representative who is informed and provides signed consent for the child, to participate in the study with edoxaban treatment. Pediatric participants with appropriate intellectual maturity will be required to sign an assent form in addition to the signed informed consent from the parent(s)/legal guardian(s) or any legally acceptable representative.\n * If a female subject of childbearing potential, tests negative for pregnancy at Screening and consents to avoid becoming pregnant by using a locally approved contraception method throughout the study\n\n","\n\n * Has evidence of symptomatic venous or arterial thrombosis and/or asymptomatic intracardiac thrombosis confirmed by a transthoracic echocardiogram during study screening period\n * Has mechanical heart valve(s)\n * Has active bleeding or high risk of bleeding contraindicating treatment with anticoagulant\n * Takes antithrombotic therapy (other than low-dose aspirin) that is not protocol-related\n * Administration of rifampin is prohibited during the study and subjects on concomitant use of rifampin are excluded\n * Has any hepatic disease associated with coagulopathy leading to a clinically relevant bleeding risk\n * Has estimated glomerular filtration rate (eGFR) <30% of normal for age and size\n * Has stage 2 hypertension defined as blood pressure systolic and/or diastolic confirmed >99th percentile plus 5 mmHg\n * Has thrombocytopenia or life expectancy less than three months\n * Has had Fontan procedure with a history of or signs/symptoms suggestive of protein-losing enteropathy\n * Is pregnant or breastfeeding\n * Has a contraindication to the use of heparin and/or vitamin K antagonist (VKA)\n * Has any condition that, as judged by the Investigator, would place the participant at increased risk of harm if he/she participated in the study, including contraindicated medications identified in the protocol",{"$nulls":4},"Actual","2018-01-10","Actual","Anticipated","2021-03-01","Anticipated","2019-02-01","2018-01-04","2018-01-04","2019-02-21","Yes","Children\nPediatrics\nCardiac disease with potential for thromboembolic complications\nProphylactic treatment\nAnticoagulant drugs","Interventional","Prevention","Parallel Assignment","None (Open Label)","Randomized",null,"17 Years","All",null,"No","Yes\nDe-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/",{"$nulls":3},"Yes","No",{"$nulls":17},"2017-000475-90","EudraCT Number","Number of participants with combined bleeding events within the main treatment period|Number of participants with combined bleeding events during the entire trial (from first to the last dose plus 30 days)","Combined bleeding events include major and clinically-relevant non-major (CRNM) bleeding events per International Society on Thrombosis and Haemostasis (ISTH) definition occurring within the main treatment period|Combined bleeding events include major and clinically-relevant non-major (CRNM) bleeding events per International Society on Thrombosis and Haemostasis (ISTH) definition occurring on treatment","within 4 months (3-month Main Treatment Period + 30-day follow-up)|within 13 months (3-month Main Treatment Period + 9-month Extension Period + 30-day follow-up)","Number of participants with symptomatic thromboembolic events (TE) in the systemic arterial or venous pathways|Number of participants who died as a result of TE between randomization and the date of the last dose of study drug plus 30 days|Number of participants who died as a result of any cause between randomization and the date of the last dose of study drug plus 30 days","Symptomatic thromboembolic events (TE) in the systemic arterial or venous pathways include deep vein thrombosis (DVT), pulmonary embolism (PE), stroke, intracardiac thrombus and myocardial infarction (MI)|within 13 months","within 4 months|within 13 months",{"$nulls":3},"Linz, Austria, 4020|Hamilton, Ontario, Canada, L8N 3Z5|Pierrefonds, Quebec, Canada, H9H 4Y6|Zagreb, Croatia, 10000|Zagazig, Al Sharkeya, Egypt, 44519|Alexandria, Egypt, 21131|Beirut, Lebanon, 166830|Be'Er Sheva, Israel, 8410101|Barcelona, Spain, 08035|London, Greater London, United Kingdom, Sw3 6Hp|Leicester, Leicestershire, United Kingdom, Le3 9Qp|Glasgow, Strathclyde, United Kingdom, G51 4Tf|Birmingham, Alabama, United States, 35233|Mesa, Arizona, United States, 85202|Los Angeles, California, United States, 90048|Charlotte, North Carolina, United States, 28204|Oklahoma City, Oklahoma, United States, 73104|Charlottesville, Virginia, United States, 22903|Seattle, Washington, United States, 98105","Alabama|Arizona|California|North Carolina|Oklahoma|Virginia|Washington","Austria|Canada|Croatia|Egypt|France|Israel|Spain|United Kingdom|United States","Kepler UniversitÃ¤tsklinikum Med Campus Iv|Ontario Mcmaster Children's Hospital|Quebec Mcgill University Health Centre/Glen Site/Montreal Children's Hospital|University Hospital Center Zagreb|Al Sharkeya Zagazig University Hospital|Alexandria Clinical Research Center, Faculty Of Medicine|Hospital|Soroka University Medical Center|Hospital Universitari Vall D'Hebron|, Greater London Royal Brompton Hospital|, Leicestershire Glenfield Hospital|, Strathclyde Ward 2B, Royal Hospital For Children|University Of Alabama At Birmingham|Cardon Childrens Medical Center|Cedars Sinai Medical Center (Ecg)|Novant Health Heart And Vascular Institute|Ou Health Sciences Center|University Of Virginia Health System|Seattle Children's Research Institute",{"$nulls":3},"Clinical Study Leader","2019-02-21","2020-05-25T16:36:11.227","2020-05-26T17:10:42.972","NCT03395639"]
["5ecbf3fb11702c1b1b916a29","NCT03395639","2019-04-05","Daiichi Sankyo","DSNKY","Recruiting","Edoxaban for Prevention of Blood Vessels Being Blocked by Clots (Thrombotic Events) in Children at Risk Because of Cardiac Disease","Edoxaban|Enoxaparin sodium|Heparin|Warfarin","FXa Inhibitor|AT III Activator|Thrombin Inhibitor|Heparin Inhibitor|Vitamin K Antagonist","No",null,"No",null,"Phase 3",2,150,"Anticipated","2018-05-15","2020-12-31",{"$nulls":5},"A committee will judge the safety and effectiveness of edoxaban and the regular treatment (standard of care).\n\nAll children in the study will receive free treatment. They will have a 2 in 3 chance to receive edoxaban, and a 1 in 3 chance to receive the standard of care for preventing blood clots.\n\nThe study will find out if edoxaban is safer and more effective than the standard of care.","The primary objective is to compare the safety of edoxaban with the standard of care (SOC) in pediatric subjects with cardiac diseases at risk of thromboembolic complications who need primary or secondary anticoagulant prophylaxis with regard to the combination of major and clinically relevant non-major (CRNM) bleeding per International Society on Thrombosis and Haemostasis [ISTH] definition.\n\nThe key secondary objective is to compare the efficacy of edoxaban against SOC with regard to the development of symptomatic thromboembolic events (TE) in the systemic arterial or venous pathways including deep vein thrombosis (DVT), pulmonary embolism (PE), stroke, intracardiac thrombus and myocardial infarction (MI), and asymptomatic intracardiac thrombus identified by cardiac imaging.","An Open-label, Randomised, Parallel-group, Multicentre, Observational Trial to Evaluate Safety and Efficacy of Edoxaban Tosylate in Children From 38 Weeks Gestational Age to Less Than 18 Years of Age With Cardiac Diseases at Risk of Thromboembolic Events","DU176b-C-U313","Cardiac Disease","Myocardial Infarction|Embolism|Pulmonary Embolism|Thrombosis|Stroke|Embolism and Thrombosis|Venous Thrombosis|Pulmonary Infarction","Heart Diseases|Vascular Diseases|Lung Diseases|Central Nervous System Diseases","Cardiovascular|Respiratory|Central Nervous System","Experimental|Active Comparator","Edoxaban|Standard of Care (SOC)","Two out of three participants will be randomized for treatment with edoxaban solution or tablets|One out of three participants will be randomized for treatment with the institution's SOC regimen","Drug","Edoxaban|Standard of Care (SOC)","Edoxaban 15 mg or 30 mg tablets for participants 12 to <18 years of age, or 60 mg edoxaban suspension (dosed as mg/kg) for participants under 12 years of age (and optionally, 12 or older), for oral administration|Standard of care could include low molecular weight heparin (LMWH) and/or VKA according to the clinical site's SOC treatment regimen","Lixiana | Savaysa|Warfarin/heparin | Enoxaparin","Edoxaban|Standard of Care (SOC)","\n\n * Is a child with cardiac disease who is at risk for thromboembolic complications and requires at least 3 months antithrombotic anticoagulant prophylaxis\n\nEither one of the following:\n\n 1. a child with cardiac disease who has a history of cardiac shunt occlusion/thrombosis, with shunt still in place (secondary prevention).OR\n    \n    \n 2. a child with cardiac disease who requires (including those already taking, and those not yet taking) anticoagulation for primary prevention of TE.\n\nCardiac conditions known to significantly increase the risk of thrombosis (hence, indications for primary TE prevention) are defined in Antithrombotic Therapy and Prevention of Thrombosis. Some examples of cardiac conditions at risk of thrombosis are Fontan surgery, heart failure, Kawasaki disease, and Blalock-Taussig and Glenn surgery.\n\n * Is a male or female child between 1 and <18 years of age (children between 38 weeks gestational age and 1 year of age will be included in the study, however, only after the safety and efficacy data of 50 subjects between 1 and <18 years of age in the edoxaban arm have been evaluated at the end of the 3-month treatment period)\n * Has parent(s)/legal guardian(s) or legally acceptable representative who is informed and provides signed consent for the child, to participate in the study with edoxaban treatment. Pediatric participants with appropriate intellectual maturity will be required to sign an assent form in addition to the signed informed consent from the parent(s)/legal guardian(s) or any legally acceptable representative.\n * If a female subject of childbearing potential, tests negative for pregnancy at Screening and consents to avoid becoming pregnant by using a locally approved contraception method throughout the study\n\n","\n\n * Has evidence of symptomatic venous or arterial thrombosis and/or asymptomatic intracardiac thrombosis confirmed by a transthoracic echocardiogram during study screening period\n * Has mechanical heart valve(s)\n * Has active bleeding or high risk of bleeding contraindicating treatment with anticoagulant\n * Takes antithrombotic therapy (other than low-dose aspirin) that is not protocol-related\n * Administration of rifampin is prohibited during the study and subjects on concomitant use of rifampin are excluded\n * Has any hepatic disease associated with coagulopathy leading to a clinically relevant bleeding risk\n * Has estimated glomerular filtration rate (eGFR) <30% of normal for age and size\n * Has stage 2 hypertension defined as blood pressure systolic and/or diastolic confirmed >99th percentile plus 5 mmHg\n * Has thrombocytopenia or life expectancy less than three months\n * Has had Fontan procedure with a history of or signs/symptoms suggestive of protein-losing enteropathy\n * Is pregnant or breastfeeding\n * Has a contraindication to the use of heparin and/or vitamin K antagonist (VKA)\n * Has any condition that, as judged by the Investigator, would place the participant at increased risk of harm if he/she participated in the study, including contraindicated medications identified in the protocol",{"$nulls":4},"Actual","2018-01-10","Actual","Anticipated","2020-12-31","Anticipated","2019-04-01","2018-01-04","2018-01-04","2019-04-03","Yes","Children\nPediatrics\nCardiac disease with potential for thromboembolic complications\nProphylactic treatment\nAnticoagulant drugs","Interventional","Prevention","Parallel Assignment","None (Open Label)","Randomized",null,"17 Years","All",null,"No","Yes\nDe-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/",{"$nulls":3},"Yes","No",{"$nulls":17},"2017-000475-90","EudraCT Number","Number of participants with combined bleeding events within the main treatment period|Number of participants with combined bleeding events during the entire trial (from first to the last dose plus 30 days)","Combined bleeding events include major and clinically-relevant non-major (CRNM) bleeding events per International Society on Thrombosis and Haemostasis (ISTH) definition occurring within the main treatment period|Combined bleeding events include major and clinically-relevant non-major (CRNM) bleeding events per International Society on Thrombosis and Haemostasis (ISTH) definition occurring on treatment","within 4 months (3-month Main Treatment Period + 30-day follow-up)|within 13 months (3-month Main Treatment Period + 9-month Extension Period + 30-day follow-up)","Number of participants with symptomatic thromboembolic events (TE) in the systemic arterial or venous pathways|Number of participants who died as a result of TE between randomization and the date of the last dose of study drug plus 30 days|Number of participants who died as a result of any cause between randomization and the date of the last dose of study drug plus 30 days","Symptomatic thromboembolic events (TE) in the systemic arterial or venous pathways include deep vein thrombosis (DVT), pulmonary embolism (PE), stroke, intracardiac thrombus and myocardial infarction (MI)|within 13 months","within 4 months|within 13 months",{"$nulls":3},"Linz, Austria, 4020|Hamilton, Ontario, Canada, L8N 3Z5|Pierrefonds, Quebec, Canada, H9H 4Y6|Zagreb, Croatia, 10000|Zagazig, Al Sharkeya, Egypt, 44519|Alexandria, Egypt, 21131|Montpellier, Herault, France, 34295|Beirut, Lebanon, 166830|Budapest, Hungary, 1096|Be'Er Sheva, Israel, 8410101|Barcelona, Spain, 08035|London, Greater London, United Kingdom, Sw3 6Hp|Leicester, Leicestershire, United Kingdom, Le3 9Qp|Glasgow, Strathclyde, United Kingdom, G51 4Tf|Birmingham, Alabama, United States, 35233|Mesa, Arizona, United States, 85202|Los Angeles, California, United States, 90048|Charlotte, North Carolina, United States, 28204|Oklahoma City, Oklahoma, United States, 73104|Charlottesville, Virginia, United States, 22903|Seattle, Washington, United States, 98105","Alabama|Arizona|California|North Carolina|Oklahoma|Virginia|Washington","Austria|Canada|Croatia|Egypt|France|Hungary|Israel|Spain|United Kingdom|United States","Kepler UniversitÃ¤tsklinikum Med Campus Iv|Ontario Mcmaster Children's Hospital|Quebec Mcgill University Health Centre/Glen Site/Montreal Children's Hospital|University Hospital Center Zagreb|Al Sharkeya Zagazig University Hospital|Alexandria Clinical Research Center, Faculty Of Medicine|Herault Pediatric And Congenital Cardiology And Pulmonology Department; Arnaud De Villeneuve University Hospital|Hospital|Gottsegen Gyorgy Orszagos Kardiologiai Intezet|Soroka University Medical Center|Hospital Universitari Vall D'Hebron|, Greater London Royal Brompton Hospital|, Leicestershire Glenfield Hospital|, Strathclyde Ward 2B, Royal Hospital For Children|University Of Alabama At Birmingham|Cardon Childrens Medical Center|Cedars Sinai Medical Center (Ecg)|Novant Health Heart And Vascular Institute|Ou Health Sciences Center|University Of Virginia Health System|Seattle Children's Research Institute",{"$nulls":3},"Clinical Study Leader","2019-04-03","2020-05-25T16:36:11.584","2020-05-26T17:10:42.972","NCT03395639"]
["5ecbf3fb307e3d1b1f8d9ca8","NCT03395639","2019-04-25","Daiichi Sankyo","DSNKY","Recruiting","Edoxaban for Prevention of Blood Vessels Being Blocked by Clots (Thrombotic Events) in Children at Risk Because of Cardiac Disease","Edoxaban|Enoxaparin sodium|Heparin|Warfarin","FXa Inhibitor|AT III Activator|Thrombin Inhibitor|Heparin Inhibitor|Vitamin K Antagonist","No",null,"No",null,"Phase 3",2,150,"Anticipated","2018-05-15","2020-12-31",{"$nulls":5},"A committee will judge the safety and effectiveness of edoxaban and the regular treatment (standard of care).\n\nAll children in the study will receive free treatment. They will have a 2 in 3 chance to receive edoxaban, and a 1 in 3 chance to receive the standard of care for preventing blood clots.\n\nThe study will find out if edoxaban is safer and more effective than the standard of care.","The primary objective is to compare the safety of edoxaban with the standard of care (SOC) in pediatric subjects with cardiac diseases at risk of thromboembolic complications who need primary or secondary anticoagulant prophylaxis with regard to the combination of major and clinically relevant non-major (CRNM) bleeding per International Society on Thrombosis and Haemostasis [ISTH] definition.\n\nThe key secondary objective is to compare the efficacy of edoxaban against SOC with regard to the development of symptomatic thromboembolic events (TE) in the systemic arterial or venous pathways including deep vein thrombosis (DVT), pulmonary embolism (PE), stroke, intracardiac thrombus and myocardial infarction (MI), and asymptomatic intracardiac thrombus identified by cardiac imaging.","An Open-label, Randomised, Parallel-group, Multicentre, Observational Trial to Evaluate Safety and Efficacy of Edoxaban Tosylate in Children From 38 Weeks Gestational Age to Less Than 18 Years of Age With Cardiac Diseases at Risk of Thromboembolic Events","DU176b-C-U313","Cardiac Disease","Myocardial Infarction|Embolism|Pulmonary Embolism|Thrombosis|Stroke|Embolism and Thrombosis|Venous Thrombosis|Pulmonary Infarction","Heart Diseases|Vascular Diseases|Lung Diseases|Central Nervous System Diseases","Cardiovascular|Respiratory|Central Nervous System","Experimental|Active Comparator","Edoxaban|Standard of Care (SOC)","Two out of three participants will be randomized for treatment with edoxaban solution or tablets|One out of three participants will be randomized for treatment with the institution's SOC regimen","Drug","Edoxaban|Standard of Care (SOC)","Edoxaban 15 mg or 30 mg tablets for participants 12 to <18 years of age, or 60 mg edoxaban suspension (dosed as mg/kg) for participants under 12 years of age (and optionally, 12 or older), for oral administration|Standard of care could include low molecular weight heparin (LMWH) and/or VKA according to the clinical site's SOC treatment regimen","Lixiana | Savaysa|Warfarin/heparin | Enoxaparin","Edoxaban|Standard of Care (SOC)","\n\n * Is a child with cardiac disease who is at risk for thromboembolic complications and requires at least 3 months antithrombotic anticoagulant prophylaxis\n\nEither one of the following:\n\n 1. a child with cardiac disease who has a history of cardiac shunt occlusion/thrombosis, with shunt still in place (secondary prevention).OR\n    \n    \n 2. a child with cardiac disease who requires (including those already taking, and those not yet taking) anticoagulation for primary prevention of TE.\n\nCardiac conditions known to significantly increase the risk of thrombosis (hence, indications for primary TE prevention) are defined in Antithrombotic Therapy and Prevention of Thrombosis. Some examples of cardiac conditions at risk of thrombosis are Fontan surgery, heart failure, Kawasaki disease, and Blalock-Taussig and Glenn surgery.\n\n * Is a male or female child between 1 and <18 years of age (children between 38 weeks gestational age and 1 year of age will be included in the study, however, only after the safety and efficacy data of 50 subjects between 1 and <18 years of age in the edoxaban arm have been evaluated at the end of the 3-month treatment period)\n * Has parent(s)/legal guardian(s) or legally acceptable representative who is informed and provides signed consent for the child, to participate in the study with edoxaban treatment. Pediatric participants with appropriate intellectual maturity will be required to sign an assent form in addition to the signed informed consent from the parent(s)/legal guardian(s) or any legally acceptable representative.\n * If a female subject of childbearing potential, tests negative for pregnancy at Screening and consents to avoid becoming pregnant by using a locally approved contraception method throughout the study\n\n","\n\n * Has evidence of symptomatic venous or arterial thrombosis and/or asymptomatic intracardiac thrombosis confirmed by a transthoracic echocardiogram during study screening period\n * Has mechanical heart valve(s)\n * Has active bleeding or high risk of bleeding contraindicating treatment with anticoagulant\n * Takes antithrombotic therapy (other than low-dose aspirin) that is not protocol-related\n * Administration of rifampin is prohibited during the study and subjects on concomitant use of rifampin are excluded\n * Has any hepatic disease associated with coagulopathy leading to a clinically relevant bleeding risk\n * Has estimated glomerular filtration rate (eGFR) <30% of normal for age and size\n * Has stage 2 hypertension defined as blood pressure systolic and/or diastolic confirmed >99th percentile plus 5 mmHg\n * Has thrombocytopenia or life expectancy less than three months\n * Has had Fontan procedure with a history of or signs/symptoms suggestive of protein-losing enteropathy\n * Is pregnant or breastfeeding\n * Has a contraindication to the use of heparin and/or vitamin K antagonist (VKA)\n * Has any condition that, as judged by the Investigator, would place the participant at increased risk of harm if he/she participated in the study, including contraindicated medications identified in the protocol",{"$nulls":4},"Actual","2018-01-10","Actual","Anticipated","2020-12-31","Anticipated","2019-04-01","2018-01-04","2018-01-04","2019-04-23","Yes","Children\nPediatrics\nCardiac disease with potential for thromboembolic complications\nProphylactic treatment\nAnticoagulant drugs","Interventional","Prevention","Parallel Assignment","None (Open Label)","Randomized",null,"17 Years","All",null,"No","Yes\nDe-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/",{"$nulls":3},"Yes","No",{"$nulls":17},"2017-000475-90","EudraCT Number","Number of participants with combined bleeding events within the main treatment period|Number of participants with combined bleeding events during the entire trial (from first to the last dose plus 30 days)","Combined bleeding events include major and clinically-relevant non-major (CRNM) bleeding events per International Society on Thrombosis and Haemostasis (ISTH) definition occurring within the main treatment period|Combined bleeding events include major and clinically-relevant non-major (CRNM) bleeding events per International Society on Thrombosis and Haemostasis (ISTH) definition occurring on treatment","within 4 months (3-month Main Treatment Period + 30-day follow-up)|within 13 months (3-month Main Treatment Period + 9-month Extension Period + 30-day follow-up)","Number of participants with symptomatic thromboembolic events (TE) in the systemic arterial or venous pathways|Number of participants who died as a result of TE between randomization and the date of the last dose of study drug plus 30 days|Number of participants who died as a result of any cause between randomization and the date of the last dose of study drug plus 30 days","Symptomatic thromboembolic events (TE) in the systemic arterial or venous pathways include deep vein thrombosis (DVT), pulmonary embolism (PE), stroke, intracardiac thrombus and myocardial infarction (MI)|within 13 months","within 4 months|within 13 months",{"$nulls":3},"Linz, Austria, 4020|Hamilton, Ontario, Canada, L8N 3Z5|Pierrefonds, Quebec, Canada, H9H 4Y6|Zagreb, Croatia, 10000|Zagazig, Al Sharkeya, Egypt, 44519|Alexandria, Egypt, 21131|Toulouse Cedex 9, Haute Garonne, France, 31059|Montpellier, Herault, France, 34295|Beirut, Lebanon, 166830|Paris, Paris Cedex 15, France, 75015|Budapest, Hungary, 1096|Be'Er Sheva, Israel, 8410101|Barcelona, Spain, 08035|London, Greater London, United Kingdom, Sw3 6Hp|Leicester, Leicestershire, United Kingdom, Le3 9Qp|Glasgow, Strathclyde, United Kingdom, G51 4Tf|Birmingham, Alabama, United States, 35233|Mesa, Arizona, United States, 85202|Los Angeles, California, United States, 90048|Charlotte, North Carolina, United States, 28204|Oklahoma City, Oklahoma, United States, 73104|Charlottesville, Virginia, United States, 22903|Seattle, Washington, United States, 98105","Alabama|Arizona|California|North Carolina|Oklahoma|Virginia|Washington","Austria|Canada|Croatia|Egypt|France|Hungary|Israel|Spain|United Kingdom|United States","Kepler UniversitÃ¤tsklinikum Med Campus Iv|Ontario Mcmaster Children's Hospital|Quebec Mcgill University Health Centre/Glen Site/Montreal Children's Hospital|University Hospital Center Zagreb|Al Sharkeya Zagazig University Hospital|Alexandria Clinical Research Center, Faculty Of Medicine|Haute Garonne HÃ´pital Des Enfants, BÃ¢timent Modulaire|Herault Pediatric And Congenital Cardiology And Pulmonology Department; Arnaud De Villeneuve University Hospital|Hospital|Paris Cedex 15 Pediatric Cardiology Department, Hospital Necker Enfants Malades, Aphp, UniversitÃ© Paris Descartes|Gottsegen Gyorgy Orszagos Kardiologiai Intezet|Soroka University Medical Center|Hospital Universitari Vall D'Hebron|, Greater London Royal Brompton Hospital|, Leicestershire Glenfield Hospital|, Strathclyde Ward 2B, Royal Hospital For Children|University Of Alabama At Birmingham|Cardon Childrens Medical Center|Cedars Sinai Medical Center (Ecg)|Novant Health Heart And Vascular Institute|Ou Health Sciences Center|University Of Virginia Health System|Seattle Children's Research Institute",{"$nulls":3},"Clinical Study Leader","2019-04-23","2020-05-25T16:36:11.417","2020-05-26T17:10:42.972","NCT03395639"]
["5ecbf3fbfe30261b1a048218","NCT03395639","2019-05-21","Daiichi Sankyo","DSNKY","Recruiting","Edoxaban for Prevention of Blood Vessels Being Blocked by Clots (Thrombotic Events) in Children at Risk Because of Cardiac Disease","Edoxaban|Enoxaparin sodium|Heparin|Warfarin","FXa Inhibitor|AT III Activator|Thrombin Inhibitor|Heparin Inhibitor|Vitamin K Antagonist","No",null,"No",null,"Phase 3",2,150,"Anticipated","2018-05-15","2020-12-31",{"$nulls":5},"A committee will judge the safety and effectiveness of edoxaban and the regular treatment (standard of care).\n\nAll children in the study will receive free treatment. They will have a 2 in 3 chance to receive edoxaban, and a 1 in 3 chance to receive the standard of care for preventing blood clots.\n\nThe study will find out if edoxaban is safer and more effective than the standard of care.","The primary objective is to compare the safety of edoxaban with the standard of care (SOC) in pediatric subjects with cardiac diseases at risk of thromboembolic complications who need primary or secondary anticoagulant prophylaxis with regard to the combination of major and clinically relevant non-major (CRNM) bleeding per International Society on Thrombosis and Haemostasis [ISTH] definition.\n\nThe key secondary objective is to compare the efficacy of edoxaban against SOC with regard to the development of symptomatic thromboembolic events (TE) in the systemic arterial or venous pathways including deep vein thrombosis (DVT), pulmonary embolism (PE), stroke, intracardiac thrombus and myocardial infarction (MI), and asymptomatic intracardiac thrombus identified by cardiac imaging.","An Open-label, Randomised, Parallel-group, Multicentre, Observational Trial to Evaluate Safety and Efficacy of Edoxaban Tosylate in Children From 38 Weeks Gestational Age to Less Than 18 Years of Age With Cardiac Diseases at Risk of Thromboembolic Events","DU176b-C-U313","Cardiac Disease","Myocardial Infarction|Embolism|Pulmonary Embolism|Thrombosis|Stroke|Embolism and Thrombosis|Venous Thrombosis|Pulmonary Infarction","Heart Diseases|Vascular Diseases|Lung Diseases|Central Nervous System Diseases","Cardiovascular|Respiratory|Central Nervous System","Experimental|Active Comparator","Edoxaban|Standard of Care (SOC)","Two out of three participants will be randomized for treatment with edoxaban solution or tablets|One out of three participants will be randomized for treatment with the institution's SOC regimen","Drug","Edoxaban|Standard of Care (SOC)","Edoxaban 15 mg or 30 mg tablets for participants 12 to <18 years of age, or 60 mg edoxaban suspension (dosed as mg/kg) for participants under 12 years of age (and optionally, 12 or older), for oral administration|Standard of care could include low molecular weight heparin (LMWH) and/or VKA according to the clinical site's SOC treatment regimen","Lixiana | Savaysa|Warfarin/heparin | Enoxaparin","Edoxaban|Standard of Care (SOC)","\n\n * Is a child with cardiac disease who is at risk for thromboembolic complications and requires at least 3 months antithrombotic anticoagulant prophylaxis\n\nEither one of the following:\n\n 1. a child with cardiac disease who has a history of cardiac shunt occlusion/thrombosis, with shunt still in place (secondary prevention).OR\n    \n    \n 2. a child with cardiac disease who requires (including those already taking, and those not yet taking) anticoagulation for primary prevention of TE.\n\nCardiac conditions known to significantly increase the risk of thrombosis (hence, indications for primary TE prevention) are defined in Antithrombotic Therapy and Prevention of Thrombosis. Some examples of cardiac conditions at risk of thrombosis are Fontan surgery, heart failure, Kawasaki disease, and Blalock-Taussig and Glenn surgery.\n\n * Is a male or female child between 1 and <18 years of age (children between 38 weeks gestational age and 1 year of age will be included in the study, however, only after the safety and efficacy data of 50 subjects between 1 and <18 years of age in the edoxaban arm have been evaluated at the end of the 3-month treatment period)\n * Has parent(s)/legal guardian(s) or legally acceptable representative who is informed and provides signed consent for the child, to participate in the study with edoxaban treatment. Pediatric participants with appropriate intellectual maturity will be required to sign an assent form in addition to the signed informed consent from the parent(s)/legal guardian(s) or any legally acceptable representative.\n * If a female subject of childbearing potential, tests negative for pregnancy at Screening and consents to avoid becoming pregnant by using a locally approved contraception method throughout the study\n\n","\n\n * Has evidence of symptomatic venous or arterial thrombosis and/or asymptomatic intracardiac thrombosis confirmed by a transthoracic echocardiogram during study screening period\n * Has mechanical heart valve(s)\n * Has active bleeding or high risk of bleeding contraindicating treatment with anticoagulant\n * Takes antithrombotic therapy (other than low-dose aspirin) that is not protocol-related\n * Administration of rifampin is prohibited during the study and subjects on concomitant use of rifampin are excluded\n * Has any hepatic disease associated with coagulopathy leading to a clinically relevant bleeding risk\n * Has estimated glomerular filtration rate (eGFR) <30% of normal for age and size\n * Has stage 2 hypertension defined as blood pressure systolic and/or diastolic confirmed >99th percentile plus 5 mmHg\n * Has thrombocytopenia or life expectancy less than three months\n * Has had Fontan procedure with a history of or signs/symptoms suggestive of protein-losing enteropathy\n * Is pregnant or breastfeeding\n * Has a contraindication to the use of heparin and/or vitamin K antagonist (VKA)\n * Has any condition that, as judged by the Investigator, would place the participant at increased risk of harm if he/she participated in the study, including contraindicated medications identified in the protocol",{"$nulls":4},"Actual","2018-01-10","Actual","Anticipated","2020-12-31","Anticipated","2019-05-01","2018-01-04","2018-01-04","2019-05-20","Yes","Children\nPediatrics\nCardiac disease with potential for thromboembolic complications\nProphylactic treatment\nAnticoagulant drugs","Interventional","Prevention","Parallel Assignment","None (Open Label)","Randomized",null,"17 Years","All",null,"No","Yes\nDe-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/",{"$nulls":3},"Yes","No",{"$nulls":17},"2017-000475-90","EudraCT Number","Number of participants with combined bleeding events within the main treatment period|Number of participants with combined bleeding events during the entire trial (from first to the last dose plus 30 days)","Combined bleeding events include major and clinically-relevant non-major (CRNM) bleeding events per International Society on Thrombosis and Haemostasis (ISTH) definition occurring within the main treatment period|Combined bleeding events include major and clinically-relevant non-major (CRNM) bleeding events per International Society on Thrombosis and Haemostasis (ISTH) definition occurring on treatment","within 4 months (3-month Main Treatment Period + 30-day follow-up)|within 13 months (3-month Main Treatment Period + 9-month Extension Period + 30-day follow-up)","Number of participants with symptomatic thromboembolic events (TE) in the systemic arterial or venous pathways|Number of participants who died as a result of TE between randomization and the date of the last dose of study drug plus 30 days|Number of participants who died as a result of any cause between randomization and the date of the last dose of study drug plus 30 days","Symptomatic thromboembolic events (TE) in the systemic arterial or venous pathways include deep vein thrombosis (DVT), pulmonary embolism (PE), stroke, intracardiac thrombus and myocardial infarction (MI)|within 13 months","within 4 months|within 13 months",{"$nulls":3},"Linz, Austria, 4020|Hamilton, Ontario, Canada, L8N 3Z5|MontrÃ©al, Quebec, Canada, H3T 1C5|Zagreb, Croatia, 10000|Zagazig, Al Sharkeya, Egypt, 44519|Alexandria, Egypt, 21131|Toulouse Cedex 9, Haute Garonne, France, 31059|Montpellier, Herault, France, 34295|Beirut, Lebanon, 166830|Paris, Paris Cedex 15, France, 75015|Budapest, Hungary, 1096|SÅ«rat, Gujarat, India, 395002|Be'Er Sheva, Israel, 8410101|Barcelona, Spain, 08035|London, Greater London, United Kingdom, Sw3 6Hp|Leicester, Leicestershire, United Kingdom, Le3 9Qp|Glasgow, Strathclyde, United Kingdom, G51 4Tf|Birmingham, Alabama, United States, 35233|Mesa, Arizona, United States, 85202|Los Angeles, California, United States, 90048|Chicago, Illinois, United States, 60612|Charlotte, North Carolina, United States, 28204|Oklahoma City, Oklahoma, United States, 73104|Charlottesville, Virginia, United States, 22903|Seattle, Washington, United States, 98105","Alabama|Arizona|California|Illinois|North Carolina|Oklahoma|Virginia|Washington","Austria|Canada|Croatia|Egypt|France|Hungary|India|Israel|Spain|United Kingdom|United States","Kepler UniversitÃ¤tsklinikum Med Campus Iv|Ontario Mcmaster Children's Hospital|Quebec Chu Sainte-Justine|University Hospital Center Zagreb|Al Sharkeya Zagazig University Hospital|Alexandria Clinical Research Center, Faculty Of Medicine|Haute Garonne HÃ´pital Des Enfants, BÃ¢timent Modulaire|Herault Pediatric And Congenital Cardiology And Pulmonology Department; Arnaud De Villeneuve University Hospital|Hospital|Paris Cedex 15 Pediatric Cardiology Department, Hospital Necker Enfants Malades, Aphp, UniversitÃ© Paris Descartes|Gottsegen Gyorgy Orszagos Kardiologiai Intezet|Gujarat Nirmal Hospital Private Limited|Soroka University Medical Center|Hospital Universitari Vall D'Hebron|, Greater London Royal Brompton Hospital|, Leicestershire Glenfield Hospital|, Strathclyde Ward 2B, Royal Hospital For Children|University Of Alabama At Birmingham|Cardon Childrens Medical Center|Cedars Sinai Medical Center (Ecg)|Rush University Medical Center|Novant Health Heart And Vascular Institute|Ou Health Sciences Center|University Of Virginia Health System|Seattle Children's Research Institute",{"$nulls":3},"Clinical Study Leader","2019-05-20","2020-05-25T16:36:11.499","2020-05-26T17:10:42.972","NCT03395639"]
["5ecbf3fb307e3d1b1f8d9ca9","NCT03395639","2019-06-24","Daiichi Sankyo","DSNKY","Recruiting","Edoxaban for Prevention of Blood Vessels Being Blocked by Clots (Thrombotic Events) in Children at Risk Because of Cardiac Disease","Edoxaban|Enoxaparin sodium|Heparin|Warfarin","FXa Inhibitor|AT III Activator|Thrombin Inhibitor|Heparin Inhibitor|Vitamin K Antagonist","No",null,"No",null,"Phase 3",2,150,"Anticipated","2018-05-15","2020-12-31",{"$nulls":5},"A committee will judge the safety and effectiveness of edoxaban and the regular treatment (standard of care).\n\nAll children in the study will receive free treatment. They will have a 2 in 3 chance to receive edoxaban, and a 1 in 3 chance to receive the standard of care for preventing blood clots.\n\nThe study will find out if edoxaban is safer and more effective than the standard of care.","The primary objective is to compare the safety of edoxaban with the standard of care (SOC) in pediatric subjects with cardiac diseases at risk of thromboembolic complications who need primary or secondary anticoagulant prophylaxis with regard to the combination of major and clinically relevant non-major (CRNM) bleeding per International Society on Thrombosis and Haemostasis [ISTH] definition.\n\nThe key secondary objective is to compare the efficacy of edoxaban against SOC with regard to the development of symptomatic thromboembolic events (TE) in the systemic arterial or venous pathways including deep vein thrombosis (DVT), pulmonary embolism (PE), stroke, intracardiac thrombus and myocardial infarction (MI), and asymptomatic intracardiac thrombus identified by cardiac imaging.","An Open-label, Randomised, Parallel-group, Multicentre, Observational Trial to Evaluate Safety and Efficacy of Edoxaban Tosylate in Children From 38 Weeks Gestational Age to Less Than 18 Years of Age With Cardiac Diseases at Risk of Thromboembolic Events","DU176b-C-U313","Cardiac Disease","Myocardial Infarction|Embolism|Pulmonary Embolism|Thrombosis|Stroke|Embolism and Thrombosis|Venous Thrombosis|Pulmonary Infarction","Heart Diseases|Vascular Diseases|Lung Diseases|Central Nervous System Diseases","Cardiovascular|Respiratory|Central Nervous System","Experimental|Active Comparator","Edoxaban|Standard of Care (SOC)","Two out of three participants will be randomized for treatment with edoxaban solution or tablets|One out of three participants will be randomized for treatment with the institution's SOC regimen","Drug","Edoxaban|Standard of Care (SOC)","Edoxaban 15 mg or 30 mg tablets for participants 12 to <18 years of age, or 60 mg edoxaban suspension (dosed as mg/kg) for participants under 12 years of age (and optionally, 12 or older), for oral administration|Standard of care could include low molecular weight heparin (LMWH) and/or VKA according to the clinical site's SOC treatment regimen","Lixiana | Savaysa|Warfarin/heparin | Enoxaparin","Edoxaban|Standard of Care (SOC)","\n\n * Is a child with cardiac disease who is at risk for thromboembolic complications and requires at least 3 months antithrombotic anticoagulant prophylaxis\n\nEither one of the following:\n\n 1. a child with cardiac disease who has a history of cardiac shunt occlusion/thrombosis, with shunt still in place (secondary prevention).OR\n    \n    \n 2. a child with cardiac disease who requires (including those already taking, and those not yet taking) anticoagulation for primary prevention of TE.\n\nCardiac conditions known to significantly increase the risk of thrombosis (hence, indications for primary TE prevention) are defined in Antithrombotic Therapy and Prevention of Thrombosis. Some examples of cardiac conditions at risk of thrombosis are Fontan surgery, heart failure, Kawasaki disease, and Blalock-Taussig and Glenn surgery.\n\n * Is a male or female child between 1 and <18 years of age (children between 38 weeks gestational age and 1 year of age will be included in the study, however, only after the safety and efficacy data of 50 subjects between 1 and <18 years of age in the edoxaban arm have been evaluated at the end of the 3-month treatment period)\n * Has parent(s)/legal guardian(s) or legally acceptable representative who is informed and provides signed consent for the child, to participate in the study with edoxaban treatment. Pediatric participants with appropriate intellectual maturity will be required to sign an assent form in addition to the signed informed consent from the parent(s)/legal guardian(s) or any legally acceptable representative.\n * If a female subject of childbearing potential, tests negative for pregnancy at Screening and consents to avoid becoming pregnant by using a locally approved contraception method throughout the study\n\n","\n\n * Has evidence of symptomatic venous or arterial thrombosis and/or asymptomatic intracardiac thrombosis confirmed by a transthoracic echocardiogram during study screening period\n * Has mechanical heart valve(s)\n * Has active bleeding or high risk of bleeding contraindicating treatment with anticoagulant\n * Takes antithrombotic therapy (other than low-dose aspirin) that is not protocol-related\n * Administration of rifampin is prohibited during the study and subjects on concomitant use of rifampin are excluded\n * Has any hepatic disease associated with coagulopathy leading to a clinically relevant bleeding risk\n * Has estimated glomerular filtration rate (eGFR) <30% of normal for age and size\n * Has stage 2 hypertension defined as blood pressure systolic and/or diastolic confirmed >99th percentile plus 5 mmHg\n * Has thrombocytopenia or life expectancy less than three months\n * Has had Fontan procedure with a history of or signs/symptoms suggestive of protein-losing enteropathy\n * Is pregnant or breastfeeding\n * Has a contraindication to the use of heparin and/or vitamin K antagonist (VKA)\n * Has any condition that, as judged by the Investigator, would place the participant at increased risk of harm if he/she participated in the study, including contraindicated medications identified in the protocol",{"$nulls":4},"Actual","2018-01-10","Actual","Anticipated","2020-12-31","Anticipated","2019-06-01","2018-01-04","2018-01-04","2019-06-21","Yes","Children\nPediatrics\nCardiac disease with potential for thromboembolic complications\nProphylactic treatment\nAnticoagulant drugs","Interventional","Prevention","Parallel Assignment","None (Open Label)","Randomized",null,"17 Years","All",null,"No","Yes\nDe-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/",{"$nulls":3},"Yes","No",{"$nulls":17},"2017-000475-90","EudraCT Number","Number of participants with combined bleeding events within the main treatment period|Number of participants with combined bleeding events during the entire trial (from first to the last dose plus 30 days)","Combined bleeding events include major and clinically-relevant non-major (CRNM) bleeding events per International Society on Thrombosis and Haemostasis (ISTH) definition occurring within the main treatment period|Combined bleeding events include major and clinically-relevant non-major (CRNM) bleeding events per International Society on Thrombosis and Haemostasis (ISTH) definition occurring on treatment","within 4 months (3-month Main Treatment Period + 30-day follow-up)|within 13 months (3-month Main Treatment Period + 9-month Extension Period + 30-day follow-up)","Number of participants with symptomatic thromboembolic events (TE) in the systemic arterial or venous pathways|Number of participants who died as a result of TE between randomization and the date of the last dose of study drug plus 30 days|Number of participants who died as a result of any cause between randomization and the date of the last dose of study drug plus 30 days","Symptomatic thromboembolic events (TE) in the systemic arterial or venous pathways include deep vein thrombosis (DVT), pulmonary embolism (PE), stroke, intracardiac thrombus and myocardial infarction (MI)|within 13 months","within 4 months|within 13 months",{"$nulls":3},"Linz, Austria, 4020|Hamilton, Ontario, Canada, L8N 3Z5|MontrÃ©al, Quebec, Canada, H3T 1C5|Zagreb, Croatia, 10000|Zagazig, Al Sharkeya, Egypt, 44519|Alexandria, Egypt, 21131|Toulouse Cedex 9, Haute Garonne, France, 31059|Montpellier, Herault, France, 34295|Beirut, Lebanon, 166830|Paris, Paris Cedex 15, France, 75015|Budapest, Hungary, 1096|SÅ«rat, Gujarat, India, 395002|Be'Er Sheva, Israel, 8410101|Barcelona, Spain, 08035|London, Greater London, United Kingdom, Sw3 6Hp|Leicester, Leicestershire, United Kingdom, Le3 9Qp|Glasgow, Strathclyde, United Kingdom, G51 4Tf|Birmingham, Alabama, United States, 35233|Mesa, Arizona, United States, 85202|Los Angeles, California, United States, 90048|Chicago, Illinois, United States, 60612|Charlotte, North Carolina, United States, 28204|Oklahoma City, Oklahoma, United States, 73104|Charlottesville, Virginia, United States, 22903|Seattle, Washington, United States, 98105","Alabama|Arizona|California|Illinois|North Carolina|Oklahoma|Virginia|Washington","Austria|Canada|Croatia|Egypt|France|Hungary|India|Israel|Spain|United Kingdom|United States","Kepler UniversitÃ¤tsklinikum Med Campus Iv|Ontario Mcmaster Children's Hospital|Quebec Chu Sainte-Justine|University Hospital Center Zagreb|Al Sharkeya Zagazig University Hospital|Alexandria Clinical Research Center, Faculty Of Medicine|Haute Garonne HÃ´pital Des Enfants, BÃ¢timent Modulaire|Herault Pediatric And Congenital Cardiology And Pulmonology Department; Arnaud De Villeneuve University Hospital|Hospital|Paris Cedex 15 Pediatric Cardiology Department, Hospital Necker Enfants Malades, Aphp, UniversitÃ© Paris Descartes|Gottsegen Gyorgy Orszagos Kardiologiai Intezet|Gujarat Nirmal Hospital Private Limited|Soroka University Medical Center|Hospital Universitari Vall D'Hebron|, Greater London Royal Brompton Hospital|, Leicestershire Glenfield Hospital|, Strathclyde Ward 2B, Royal Hospital For Children|University Of Alabama At Birmingham|Cardon Childrens Medical Center|Cedars Sinai Medical Center (Ecg)|Rush University Medical Center|Novant Health Heart And Vascular Institute|Ou Health Sciences Center|University Of Virginia Health System|Seattle Children's Research Institute",{"$nulls":3},"Clinical Study Leader","2019-06-21","2020-05-25T16:36:11.583","2020-05-26T17:10:42.972","NCT03395639"]
["5ecbf3fbfeab101b15530849","NCT03395639","2019-08-26","Daiichi Sankyo","DSNKY","Recruiting","Edoxaban for Prevention of Blood Vessels Being Blocked by Clots (Thrombotic Events) in Children at Risk Because of Cardiac Disease","Edoxaban|Enoxaparin sodium|Heparin|Warfarin","FXa Inhibitor|AT III Activator|Thrombin Inhibitor|Heparin Inhibitor|Vitamin K Antagonist","No",null,"No",null,"Phase 3",2,150,"Anticipated","2018-05-15","2020-12-31",{"$nulls":5},"A committee will judge the safety and effectiveness of edoxaban and the regular treatment (standard of care).\n\nAll children in the study will receive free treatment. They will have a 2 in 3 chance to receive edoxaban, and a 1 in 3 chance to receive the standard of care for preventing blood clots.\n\nThe study will find out if edoxaban is safer and more effective than the standard of care.","The primary objective is to compare the safety of edoxaban with the standard of care (SOC) in pediatric subjects with cardiac diseases at risk of thromboembolic complications who need primary or secondary anticoagulant prophylaxis with regard to the combination of major and clinically relevant non-major (CRNM) bleeding per International Society on Thrombosis and Haemostasis [ISTH] definition.\n\nThe key secondary objective is to compare the efficacy of edoxaban against SOC with regard to the development of symptomatic thromboembolic events (TE) in the systemic arterial or venous pathways including deep vein thrombosis (DVT), pulmonary embolism (PE), stroke, intracardiac thrombus and myocardial infarction (MI), and asymptomatic intracardiac thrombus identified by cardiac imaging.","An Open-label, Randomised, Parallel-group, Multicentre, Observational Trial to Evaluate Safety and Efficacy of Edoxaban Tosylate in Children From 38 Weeks Gestational Age to Less Than 18 Years of Age With Cardiac Diseases at Risk of Thromboembolic Events","DU176b-C-U313","Cardiac Disease","Myocardial Infarction|Embolism|Pulmonary Embolism|Thrombosis|Stroke|Embolism and Thrombosis|Venous Thrombosis|Pulmonary Infarction","Heart Diseases|Vascular Diseases|Lung Diseases|Central Nervous System Diseases","Cardiovascular|Respiratory|Central Nervous System","Experimental|Active Comparator","Edoxaban|Standard of Care (SOC)","Two out of three participants will be randomized for treatment with edoxaban solution or tablets|One out of three participants will be randomized for treatment with the institution's SOC regimen","Drug","Edoxaban|Standard of Care (SOC)","Edoxaban 15 mg or 30 mg tablets for participants 12 to <18 years of age, or 60 mg edoxaban suspension (dosed as mg/kg) for participants under 12 years of age (and optionally, 12 or older), for oral administration|Standard of care could include low molecular weight heparin (LMWH) and/or VKA according to the clinical site's SOC treatment regimen","Lixiana | Savaysa|Warfarin/heparin | Enoxaparin","Edoxaban|Standard of Care (SOC)","\n\n * Is a child with cardiac disease who is at risk for thromboembolic complications and requires at least 3 months antithrombotic anticoagulant prophylaxis\n\nEither one of the following:\n\n 1. a child with cardiac disease who has a history of cardiac shunt occlusion/thrombosis, with shunt still in place (secondary prevention).OR\n    \n    \n 2. a child with cardiac disease who requires (including those already taking, and those not yet taking) anticoagulation for primary prevention of TE.\n\nCardiac conditions known to significantly increase the risk of thrombosis (hence, indications for primary TE prevention) are defined in Antithrombotic Therapy and Prevention of Thrombosis. Some examples of cardiac conditions at risk of thrombosis are Fontan surgery, heart failure, Kawasaki disease, and Blalock-Taussig and Glenn surgery.\n\n * Is a male or female child between 1 and <18 years of age (children between 38 weeks gestational age and 1 year of age will be included in the study, however, only after the safety and efficacy data of 50 subjects between 1 and <18 years of age in the edoxaban arm have been evaluated at the end of the 3-month treatment period)\n * Has parent(s)/legal guardian(s) or legally acceptable representative who is informed and provides signed consent for the child, to participate in the study with edoxaban treatment. Pediatric participants with appropriate intellectual maturity will be required to sign an assent form in addition to the signed informed consent from the parent(s)/legal guardian(s) or any legally acceptable representative.\n * If a female subject of childbearing potential, tests negative for pregnancy at Screening and consents to avoid becoming pregnant by using a locally approved contraception method throughout the study\n\n","\n\n * Has evidence of symptomatic venous or arterial thrombosis and/or asymptomatic intracardiac thrombosis confirmed by a transthoracic echocardiogram during study screening period\n * Has mechanical heart valve(s)\n * Has active bleeding or high risk of bleeding contraindicating treatment with anticoagulant\n * Takes antithrombotic therapy (other than low-dose aspirin) that is not protocol-related\n * Administration of rifampin is prohibited during the study and subjects on concomitant use of rifampin are excluded\n * Has any hepatic disease associated with coagulopathy leading to a clinically relevant bleeding risk\n * Has estimated glomerular filtration rate (eGFR) <30% of normal for age and size\n * Has stage 2 hypertension defined as blood pressure systolic and/or diastolic confirmed >99th percentile plus 5 mmHg\n * Has thrombocytopenia or life expectancy less than three months\n * Has had Fontan procedure with a history of or signs/symptoms suggestive of protein-losing enteropathy\n * Is pregnant or breastfeeding\n * Has a contraindication to the use of heparin and/or vitamin K antagonist (VKA)\n * Has any condition that, as judged by the Investigator, would place the participant at increased risk of harm if he/she participated in the study, including contraindicated medications identified in the protocol",{"$nulls":4},"Actual","2018-01-10","Actual","Anticipated","2020-12-31","Anticipated","2019-08-01","2018-01-04","2018-01-04","2019-08-22","Yes","Children\nPediatrics\nCardiac disease with potential for thromboembolic complications\nProphylactic treatment\nAnticoagulant drugs","Interventional","Prevention","Parallel Assignment","None (Open Label)","Randomized",null,"17 Years","All",null,"No","Yes\nDe-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/",{"$nulls":3},"Yes","No",{"$nulls":17},"2017-000475-90","EudraCT Number","Number of participants with combined bleeding events within the main treatment period|Number of participants with combined bleeding events during the entire trial (from first to the last dose plus 30 days)","Combined bleeding events include major and clinically-relevant non-major (CRNM) bleeding events per International Society on Thrombosis and Haemostasis (ISTH) definition occurring within the main treatment period|Combined bleeding events include major and clinically-relevant non-major (CRNM) bleeding events per International Society on Thrombosis and Haemostasis (ISTH) definition occurring on treatment","within 4 months (3-month Main Treatment Period + 30-day follow-up)|within 13 months (3-month Main Treatment Period + 9-month Extension Period + 30-day follow-up)","Number of participants with symptomatic thromboembolic events (TE) in the systemic arterial or venous pathways|Number of participants who died as a result of TE between randomization and the date of the last dose of study drug plus 30 days|Number of participants who died as a result of any cause between randomization and the date of the last dose of study drug plus 30 days","Symptomatic thromboembolic events (TE) in the systemic arterial or venous pathways include deep vein thrombosis (DVT), pulmonary embolism (PE), stroke, intracardiac thrombus and myocardial infarction (MI)|within 13 months","within 4 months|within 13 months",{"$nulls":3},"Linz, Austria, 4020|Hamilton, Ontario, Canada, L8N 3Z5|MontrÃ©al, Quebec, Canada, H3T 1C5|Zagreb, Croatia, 10000|Zagazig, Al Sharkeya, Egypt, 44519|Alexandria, Egypt, 21131|Toulouse Cedex 9, Haute Garonne, France, 31059|Montpellier, Herault, France, 34295|Beirut, Lebanon, 166830|Paris, Paris Cedex 15, France, 75015|Budapest, Hungary, 1096|SÅ«rat, Gujarat, India, 395002|Be'Er Sheva, Israel, 8410101|Barcelona, Spain, 08035|London, Greater London, United Kingdom, Sw3 6Hp|Leicester, Leicestershire, United Kingdom, Le3 9Qp|Glasgow, Strathclyde, United Kingdom, G51 4Tf|Birmingham, Alabama, United States, 35233|Mesa, Arizona, United States, 85202|Los Angeles, California, United States, 90048|Chicago, Illinois, United States, 60612|Charlotte, North Carolina, United States, 28204 East Carolina Heart Institute @ EcuGreenville, North Carolina, United States, 27834|Oklahoma City, Oklahoma, United States, 73104|Charlottesville, Virginia, United States, 22903|Seattle, Washington, United States, 98105","Alabama|Arizona|California|Illinois|North Carolina|Oklahoma|Virginia|Washington","Austria|Canada|Croatia|Egypt|France|Hungary|India|Israel|Spain|United Kingdom|United States","Kepler UniversitÃ¤tsklinikum Med Campus Iv|Ontario Mcmaster Children's Hospital|Quebec Chu Sainte-Justine|University Hospital Center Zagreb|Al Sharkeya Zagazig University Hospital|Alexandria Clinical Research Center, Faculty Of Medicine|Haute Garonne HÃ´pital Des Enfants, BÃ¢timent Modulaire|Herault Pediatric And Congenital Cardiology And Pulmonology Department; Arnaud De Villeneuve University Hospital|Hospital|Paris Cedex 15 Pediatric Cardiology Department, Hospital Necker Enfants Malades, Aphp, UniversitÃ© Paris Descartes|Gottsegen Gyorgy Orszagos Kardiologiai Intezet|Gujarat Nirmal Hospital Private Limited|Soroka University Medical Center|Hospital Universitari Vall D'Hebron|, Greater London Royal Brompton Hospital|, Leicestershire Glenfield Hospital|, Strathclyde Ward 2B, Royal Hospital For Children|University Of Alabama At Birmingham|Cardon Childrens Medical Center|Cedars Sinai Medical Center (Ecg)|Rush University Medical Center|Novant Health Heart And Vascular Institute|Ou Health Sciences Center|University Of Virginia Health System|Seattle Children's Research Institute",{"$nulls":3},"Clinical Study Leader","2019-08-22","2020-05-25T16:36:11.687","2020-05-26T17:10:42.972","NCT03395639"]
["5ecbf3fbe2561b1b11905d14","NCT03395639","2019-09-25","Daiichi Sankyo","DSNKY","Recruiting","Edoxaban for Prevention of Blood Vessels Being Blocked by Clots (Thrombotic Events) in Children at Risk Because of Cardiac Disease","Edoxaban|Enoxaparin sodium|Heparin|Warfarin","FXa Inhibitor|AT III Activator|Thrombin Inhibitor|Heparin Inhibitor|Vitamin K Antagonist","No",null,"No",null,"Phase 3",2,150,"Anticipated","2018-05-15","2020-12-31",{"$nulls":5},"A committee will judge the safety and effectiveness of edoxaban and the regular treatment (standard of care).\n\nAll children in the study will receive free treatment. They will have a 2 in 3 chance to receive edoxaban, and a 1 in 3 chance to receive the standard of care for preventing blood clots.\n\nThe study will find out if edoxaban is safer and more effective than the standard of care.","The primary objective is to compare the safety of edoxaban with the standard of care (SOC) in pediatric subjects with cardiac diseases at risk of thromboembolic complications who need primary or secondary anticoagulant prophylaxis with regard to the combination of major and clinically relevant non-major (CRNM) bleeding per International Society on Thrombosis and Haemostasis [ISTH] definition.\n\nThe key secondary objective is to compare the efficacy of edoxaban against SOC with regard to the development of symptomatic thromboembolic events (TE) in the systemic arterial or venous pathways including deep vein thrombosis (DVT), pulmonary embolism (PE), stroke, intracardiac thrombus and myocardial infarction (MI), and asymptomatic intracardiac thrombus identified by cardiac imaging.","An Open-label, Randomised, Parallel-group, Multicentre, Observational Trial to Evaluate Safety and Efficacy of Edoxaban Tosylate in Children From 38 Weeks Gestational Age to Less Than 18 Years of Age With Cardiac Diseases at Risk of Thromboembolic Events","DU176b-C-U313","Cardiac Disease","Myocardial Infarction|Embolism|Pulmonary Embolism|Thrombosis|Stroke|Embolism and Thrombosis|Venous Thrombosis|Pulmonary Infarction","Heart Diseases|Vascular Diseases|Lung Diseases|Central Nervous System Diseases","Cardiovascular|Respiratory|Central Nervous System","Experimental|Active Comparator","Edoxaban|Standard of Care (SOC)","Two out of three participants will be randomized for treatment with edoxaban solution or tablets|One out of three participants will be randomized for treatment with the institution's SOC regimen","Drug","Edoxaban|Standard of Care (SOC)","Edoxaban 15 mg or 30 mg tablets for participants 12 to <18 years of age, or 60 mg edoxaban suspension (dosed as mg/kg) for participants under 12 years of age (and optionally, 12 or older), for oral administration|Standard of care could include low molecular weight heparin (LMWH) and/or VKA according to the clinical site's SOC treatment regimen","Lixiana | Savaysa|Warfarin/heparin | Enoxaparin","Edoxaban|Standard of Care (SOC)","\n\n * Is a child with cardiac disease who is at risk for thromboembolic complications and requires at least 3 months antithrombotic anticoagulant prophylaxis\n\nEither one of the following:\n\n 1. a child with cardiac disease who has a history of cardiac shunt occlusion/thrombosis, with shunt still in place (secondary prevention).OR\n    \n    \n 2. a child with cardiac disease who requires (including those already taking, and those not yet taking) anticoagulation for primary prevention of TE.\n\nCardiac conditions known to significantly increase the risk of thrombosis (hence, indications for primary TE prevention) are defined in Antithrombotic Therapy and Prevention of Thrombosis. Some examples of cardiac conditions at risk of thrombosis are Fontan surgery, heart failure, Kawasaki disease, and Blalock-Taussig and Glenn surgery.\n\n * Is a male or female child between 1 and <18 years of age (children between 38 weeks gestational age and 1 year of age will be included in the study, however, only after the safety and efficacy data of 50 subjects between 1 and <18 years of age in the edoxaban arm have been evaluated at the end of the 3-month treatment period)\n * Has parent(s)/legal guardian(s) or legally acceptable representative who is informed and provides signed consent for the child, to participate in the study with edoxaban treatment. Pediatric participants with appropriate intellectual maturity will be required to sign an assent form in addition to the signed informed consent from the parent(s)/legal guardian(s) or any legally acceptable representative.\n * If a female subject of childbearing potential, tests negative for pregnancy at Screening and consents to avoid becoming pregnant by using a locally approved contraception method throughout the study\n\n","\n\n * Has evidence of symptomatic venous or arterial thrombosis and/or asymptomatic intracardiac thrombosis confirmed by a transthoracic echocardiogram during study screening period\n * Has mechanical heart valve(s)\n * Has active bleeding or high risk of bleeding contraindicating treatment with anticoagulant\n * Takes antithrombotic therapy (other than low-dose aspirin) that is not protocol-related\n * Administration of rifampin is prohibited during the study and subjects on concomitant use of rifampin are excluded\n * Has any hepatic disease associated with coagulopathy leading to a clinically relevant bleeding risk\n * Has estimated glomerular filtration rate (eGFR) <30% of normal for age and size\n * Has stage 2 hypertension defined as blood pressure systolic and/or diastolic confirmed >99th percentile plus 5 mmHg\n * Has thrombocytopenia or life expectancy less than three months\n * Has had Fontan procedure with a history of or signs/symptoms suggestive of protein-losing enteropathy\n * Is pregnant or breastfeeding\n * Has a contraindication to the use of heparin and/or vitamin K antagonist (VKA)\n * Has any condition that, as judged by the Investigator, would place the participant at increased risk of harm if he/she participated in the study, including contraindicated medications identified in the protocol",{"$nulls":4},"Actual","2018-01-10","Actual","Anticipated","2020-12-31","Anticipated","2019-09-01","2018-01-04","2018-01-04","2019-09-24","Yes","Children\nPediatrics\nCardiac disease with potential for thromboembolic complications\nProphylactic treatment\nAnticoagulant drugs","Interventional","Prevention","Parallel Assignment","None (Open Label)","Randomized",null,"17 Years","All",null,"No","Yes\nDe-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/",{"$nulls":3},"Yes","No",{"$nulls":17},"2017-000475-90","EudraCT Number","Number of participants with combined bleeding events within the main treatment period|Number of participants with combined bleeding events during the entire trial (from first to the last dose plus 30 days)","Combined bleeding events include major and clinically-relevant non-major (CRNM) bleeding events per International Society on Thrombosis and Haemostasis (ISTH) definition occurring within the main treatment period|Combined bleeding events include major and clinically-relevant non-major (CRNM) bleeding events per International Society on Thrombosis and Haemostasis (ISTH) definition occurring on treatment","within 4 months (3-month Main Treatment Period + 30-day follow-up)|within 13 months (3-month Main Treatment Period + 9-month Extension Period + 30-day follow-up)","Number of participants with symptomatic thromboembolic events (TE) in the systemic arterial or venous pathways|Number of participants who died as a result of TE between randomization and the date of the last dose of study drug plus 30 days|Number of participants who died as a result of any cause between randomization and the date of the last dose of study drug plus 30 days","Symptomatic thromboembolic events (TE) in the systemic arterial or venous pathways include deep vein thrombosis (DVT), pulmonary embolism (PE), stroke, intracardiac thrombus and myocardial infarction (MI)|within 13 months","within 4 months|within 13 months",{"$nulls":3},"Linz, Austria, 4020|Hamilton, Ontario, Canada, L8N 3Z5|MontrÃ©al, Quebec, Canada, H3T 1C5|Zagreb, Croatia, 10000|Zagazig, Al Sharkeya, Egypt, 44519|Alexandria, Egypt, 21131|Toulouse Cedex 9, Haute Garonne, France, 31059|Montpellier, Herault, France, 34295|Beirut, Lebanon, 166830|Paris, Paris Cedex 15, France, 75015|Budapest, Hungary, 1096|SÅ«rat, Gujarat, India, 395002|Be'Er Sheva, Israel, 8410101|Beirut, Lebanon, 11-0236|Barcelona, Spain, 08035|London, Greater London, United Kingdom, Sw3 6Hp|Leicester, Leicestershire, United Kingdom, Le3 9Qp|Glasgow, Strathclyde, United Kingdom, G51 4Tf|Birmingham, Alabama, United States, 35233|Mesa, Arizona, United States, 85202|Los Angeles, California, United States, 90048|Chicago, Illinois, United States, 60612|Charlotte, North Carolina, United States, 28204 East Carolina Heart Institute @ EcuGreenville, North Carolina, United States, 27834|Oklahoma City, Oklahoma, United States, 73104|Charlottesville, Virginia, United States, 22903|Seattle, Washington, United States, 98105","Alabama|Arizona|California|Illinois|North Carolina|Oklahoma|Virginia|Washington","Austria|Canada|Croatia|Egypt|France|Hungary|India|Israel|Lebanon|Spain|United Kingdom|United States","Kepler UniversitÃ¤tsklinikum Med Campus Iv|Ontario Mcmaster Children's Hospital|Quebec Chu Sainte-Justine|University Hospital Center Zagreb|Al Sharkeya Zagazig University Hospital|Alexandria Clinical Research Center, Faculty Of Medicine|Haute Garonne HÃ´pital Des Enfants, BÃ¢timent Modulaire|Herault Pediatric And Congenital Cardiology And Pulmonology Department; Arnaud De Villeneuve University Hospital|Hospital|Paris Cedex 15 Pediatric Cardiology Department, Hospital Necker Enfants Malades, Aphp, UniversitÃ© Paris Descartes|Gottsegen Gyorgy Orszagos Kardiologiai Intezet|Gujarat Nirmal Hospital Private Limited|Soroka University Medical Center|Children's Heart Centre At The American University Of Beirut Medical Center|Hospital Universitari Vall D'Hebron|, Greater London Royal Brompton Hospital|, Leicestershire Glenfield Hospital|, Strathclyde Ward 2B, Royal Hospital For Children|University Of Alabama At Birmingham|Cardon Childrens Medical Center|Cedars Sinai Medical Center (Ecg)|Rush University Medical Center|Novant Health Heart And Vascular Institute|Ou Health Sciences Center|University Of Virginia Health System|Seattle Children's Research Institute",{"$nulls":3},"Clinical Study Leader","2019-09-24","2020-05-25T16:36:11.623","2020-05-26T17:10:42.972","NCT03395639"]
["5ecbf3fbfe30261b1a048219","NCT03395639","2019-10-23","Daiichi Sankyo","DSNKY","Recruiting","Edoxaban for Prevention of Blood Vessels Being Blocked by Clots (Thrombotic Events) in Children at Risk Because of Cardiac Disease","Edoxaban|Enoxaparin sodium|Heparin|Warfarin","FXa Inhibitor|AT III Activator|Thrombin Inhibitor|Heparin Inhibitor|Vitamin K Antagonist","No",null,"No",null,"Phase 3",2,150,"Anticipated","2018-05-15","2020-12-31",{"$nulls":5},"A committee will judge the safety and effectiveness of edoxaban and the regular treatment (standard of care).\n\nAll children in the study will receive free treatment. They will have a 2 in 3 chance to receive edoxaban, and a 1 in 3 chance to receive the standard of care for preventing blood clots.\n\nThe study will find out if edoxaban is safer and more effective than the standard of care.","The primary objective is to compare the safety of edoxaban with the standard of care (SOC) in pediatric subjects with cardiac diseases at risk of thromboembolic complications who need primary or secondary anticoagulant prophylaxis with regard to the combination of major and clinically relevant non-major (CRNM) bleeding per International Society on Thrombosis and Haemostasis [ISTH] definition.\n\nThe key secondary objective is to compare the efficacy of edoxaban against SOC with regard to the development of symptomatic thromboembolic events (TE) in the systemic arterial or venous pathways including deep vein thrombosis (DVT), pulmonary embolism (PE), stroke, intracardiac thrombus and myocardial infarction (MI), and asymptomatic intracardiac thrombus identified by cardiac imaging.","An Open-label, Randomised, Parallel-group, Multicentre, Observational Trial to Evaluate Safety and Efficacy of Edoxaban Tosylate in Children From 38 Weeks Gestational Age to Less Than 18 Years of Age With Cardiac Diseases at Risk of Thromboembolic Events","DU176b-C-U313","Cardiac Disease","Myocardial Infarction|Embolism|Pulmonary Embolism|Thrombosis|Stroke|Embolism and Thrombosis|Venous Thrombosis|Pulmonary Infarction","Heart Diseases|Vascular Diseases|Lung Diseases|Central Nervous System Diseases","Cardiovascular|Respiratory|Central Nervous System","Experimental|Active Comparator","Edoxaban|Standard of Care (SOC)","Two out of three participants will be randomized for treatment with edoxaban solution or tablets|One out of three participants will be randomized for treatment with the institution's SOC regimen","Drug","Edoxaban|Standard of Care (SOC)","Edoxaban 15 mg or 30 mg tablets for participants 12 to <18 years of age, or 60 mg edoxaban suspension (dosed as mg/kg) for participants under 12 years of age (and optionally, 12 or older), for oral administration|Standard of care could include low molecular weight heparin (LMWH) and/or VKA according to the clinical site's SOC treatment regimen","Lixiana | Savaysa|Warfarin/heparin | Enoxaparin","Edoxaban|Standard of Care (SOC)","\n\n * Is a child with cardiac disease who is at risk for thromboembolic complications and requires at least 3 months antithrombotic anticoagulant prophylaxis\n\nEither one of the following:\n\n 1. a child with cardiac disease who has a history of cardiac shunt occlusion/thrombosis, with shunt still in place (secondary prevention).OR\n    \n    \n 2. a child with cardiac disease who requires (including those already taking, and those not yet taking) anticoagulation for primary prevention of TE.\n\nCardiac conditions known to significantly increase the risk of thrombosis (hence, indications for primary TE prevention) are defined in Antithrombotic Therapy and Prevention of Thrombosis. Some examples of cardiac conditions at risk of thrombosis are Fontan surgery, heart failure, Kawasaki disease, and Blalock-Taussig and Glenn surgery.\n\n * Is a male or female child between 1 and <18 years of age (children between 38 weeks gestational age and 1 year of age will be included in the study, however, only after the safety and efficacy data of 50 subjects between 1 and <18 years of age in the edoxaban arm have been evaluated at the end of the 3-month treatment period)\n * Has parent(s)/legal guardian(s) or legally acceptable representative who is informed and provides signed consent for the child, to participate in the study with edoxaban treatment. Pediatric participants with appropriate intellectual maturity will be required to sign an assent form in addition to the signed informed consent from the parent(s)/legal guardian(s) or any legally acceptable representative.\n * If a female subject of childbearing potential, tests negative for pregnancy at Screening and consents to avoid becoming pregnant by using a locally approved contraception method throughout the study\n\n","\n\n * Has evidence of symptomatic venous or arterial thrombosis and/or asymptomatic intracardiac thrombosis confirmed by a transthoracic echocardiogram during study screening period\n * Has mechanical heart valve(s)\n * Has active bleeding or high risk of bleeding contraindicating treatment with anticoagulant\n * Takes antithrombotic therapy (other than low-dose aspirin) that is not protocol-related\n * Administration of rifampin is prohibited during the study and subjects on concomitant use of rifampin are excluded\n * Has any hepatic disease associated with coagulopathy leading to a clinically relevant bleeding risk\n * Has estimated glomerular filtration rate (eGFR) <30% of normal for age and size\n * Has stage 2 hypertension defined as blood pressure systolic and/or diastolic confirmed >99th percentile plus 5 mmHg\n * Has thrombocytopenia or life expectancy less than three months\n * Has had Fontan procedure with a history of or signs/symptoms suggestive of protein-losing enteropathy\n * Is pregnant or breastfeeding\n * Has a contraindication to the use of heparin and/or vitamin K antagonist (VKA)\n * Has any condition that, as judged by the Investigator, would place the participant at increased risk of harm if he/she participated in the study, including contraindicated medications identified in the protocol",{"$nulls":4},"Actual","2018-01-10","Actual","Anticipated","2020-12-31","Anticipated","2019-10-01","2018-01-04","2018-01-04","2019-10-22","Yes","Children\nPediatrics\nCardiac disease with potential for thromboembolic complications\nProphylactic treatment\nAnticoagulant drugs","Interventional","Prevention","Parallel Assignment","None (Open Label)","Randomized",null,"17 Years","All",null,"No","Yes\nDe-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/",{"$nulls":3},"Yes","No",{"$nulls":17},"2017-000475-90","EudraCT Number","Number of participants with combined bleeding events within the main treatment period|Number of participants with combined bleeding events during the entire trial (from first to the last dose plus 30 days)","Combined bleeding events include major and clinically-relevant non-major (CRNM) bleeding events per International Society on Thrombosis and Haemostasis (ISTH) definition occurring within the main treatment period|Combined bleeding events include major and clinically-relevant non-major (CRNM) bleeding events per International Society on Thrombosis and Haemostasis (ISTH) definition occurring on treatment","within 4 months (3-month Main Treatment Period + 30-day follow-up)|within 13 months (3-month Main Treatment Period + 9-month Extension Period + 30-day follow-up)","Number of participants with symptomatic thromboembolic events (TE) in the systemic arterial or venous pathways|Number of participants who died as a result of TE between randomization and the date of the last dose of study drug plus 30 days|Number of participants who died as a result of any cause between randomization and the date of the last dose of study drug plus 30 days","Symptomatic thromboembolic events (TE) in the systemic arterial or venous pathways include deep vein thrombosis (DVT), pulmonary embolism (PE), stroke, intracardiac thrombus and myocardial infarction (MI)|within 13 months","within 4 months|within 13 months",{"$nulls":3},"Linz, Austria, 4020|Hamilton, Ontario, Canada, L8N 3Z5|MontrÃ©al, Quebec, Canada, H3T 1C5|Zagreb, Croatia, 10000|Zagazig, Al Sharkeya, Egypt, 44519|Alexandria, Egypt, 21131|Toulouse Cedex 9, Haute Garonne, France, 31059|Montpellier, Herault, France, 34295|Beirut, Lebanon, 166830|Paris, Paris Cedex 15, France, 75015|Budapest, Hungary, 1096|SÅ«rat, Gujarat, India, 395002|Be'Er Sheva, Israel, 8410101|Beirut, Lebanon, 11-0236|Barcelona, Spain, 08035|London, Greater London, United Kingdom, Sw3 6Hp|Leicester, Leicestershire, United Kingdom, Le3 9Qp|Glasgow, Strathclyde, United Kingdom, G51 4Tf|Birmingham, Alabama, United States, 35233|Mesa, Arizona, United States, 85202|Los Angeles, California, United States, 90048|Chicago, Illinois, United States, 60612|Charlotte, North Carolina, United States, 28204 East Carolina Heart Institute @ EcuGreenville, North Carolina, United States, 27834|Oklahoma City, Oklahoma, United States, 73104|Charlottesville, Virginia, United States, 22903|Seattle, Washington, United States, 98105","Alabama|Arizona|California|Illinois|North Carolina|Oklahoma|Virginia|Washington","Austria|Canada|Croatia|Egypt|France|Hungary|India|Israel|Lebanon|Spain|United Kingdom|United States","Kepler UniversitÃ¤tsklinikum Med Campus Iv|Ontario Mcmaster Children's Hospital|Quebec Chu Sainte-Justine|University Hospital Center Zagreb|Al Sharkeya Zagazig University Hospital|Alexandria Clinical Research Center, Faculty Of Medicine|Haute Garonne HÃ´pital Des Enfants, BÃ¢timent Modulaire|Herault Pediatric And Congenital Cardiology And Pulmonology Department; Arnaud De Villeneuve University Hospital|Hospital|Paris Cedex 15 Pediatric Cardiology Department, Hospital Necker Enfants Malades, Aphp, UniversitÃ© Paris Descartes|Gottsegen Gyorgy Orszagos Kardiologiai Intezet|Gujarat Nirmal Hospital Private Limited|Soroka University Medical Center|Children's Heart Centre At The American University Of Beirut Medical Center|Hospital Universitari Vall D'Hebron|, Greater London Royal Brompton Hospital|, Leicestershire Glenfield Hospital|, Strathclyde Ward 2B, Royal Hospital For Children|University Of Alabama At Birmingham|Cardon Childrens Medical Center|Cedars Sinai Medical Center (Ecg)|Rush University Medical Center|Novant Health Heart And Vascular Institute|Ou Health Sciences Center|University Of Virginia Health System|Seattle Children's Research Institute",{"$nulls":3},"Clinical Study Leader","2019-10-22","2020-05-25T16:36:11.754","2020-05-26T17:10:42.972","NCT03395639"]
["5ecbf3fb11702c1b1b916a2a","NCT03395639","2020-01-07","Daiichi Sankyo","DSNKY","Recruiting","Edoxaban for Prevention of Blood Vessels Being Blocked by Clots (Thrombotic Events) in Children at Risk Because of Cardiac Disease","Edoxaban|Enoxaparin sodium|Heparin|Warfarin","FXa Inhibitor|AT III Activator|Thrombin Inhibitor|Heparin Inhibitor|Vitamin K Antagonist","No",null,"No",null,"Phase 3",2,150,"Anticipated","2018-05-15","2020-12-31",{"$nulls":5},"A committee will judge the safety and effectiveness of edoxaban and the regular treatment (standard of care).\n\nAll children in the study will receive free treatment. They will have a 2 in 3 chance to receive edoxaban, and a 1 in 3 chance to receive the standard of care for preventing blood clots.\n\nThe study will find out if edoxaban is safer and more effective than the standard of care.","The primary objective is to compare the safety of edoxaban with the standard of care (SOC) in pediatric subjects with cardiac diseases at risk of thromboembolic complications who need primary or secondary anticoagulant prophylaxis with regard to the combination of major and clinically relevant non-major (CRNM) bleeding per International Society on Thrombosis and Haemostasis [ISTH] definition.\n\nThe key secondary objective is to compare the efficacy of edoxaban against SOC with regard to the development of symptomatic thromboembolic events (TE) in the systemic arterial or venous pathways including deep vein thrombosis (DVT), pulmonary embolism (PE), stroke, intracardiac thrombus and myocardial infarction (MI), and asymptomatic intracardiac thrombus identified by cardiac imaging.","An Open-label, Randomised, Parallel-group, Multicentre, Observational Trial to Evaluate Safety and Efficacy of Edoxaban Tosylate in Children From 38 Weeks Gestational Age to Less Than 18 Years of Age With Cardiac Diseases at Risk of Thromboembolic Events","DU176b-C-U313","Cardiac Disease","Myocardial Infarction|Embolism|Pulmonary Embolism|Thrombosis|Stroke|Embolism and Thrombosis|Venous Thrombosis|Pulmonary Infarction","Heart Diseases|Vascular Diseases|Lung Diseases|Central Nervous System Diseases","Cardiovascular|Respiratory|Central Nervous System","Experimental|Active Comparator","Edoxaban|Standard of Care (SOC)","Two out of three participants will be randomized for treatment with edoxaban solution or tablets|One out of three participants will be randomized for treatment with the institution's SOC regimen","Drug","Edoxaban|Standard of Care (SOC)","Edoxaban 15 mg or 30 mg tablets for participants 12 to <18 years of age, or 60 mg edoxaban suspension (dosed as mg/kg) for participants under 12 years of age (and optionally, 12 or older), for oral administration|Standard of care could include low molecular weight heparin (LMWH) and/or VKA according to the clinical site's SOC treatment regimen","Lixiana | Savaysa|Warfarin/heparin | Enoxaparin","Edoxaban|Standard of Care (SOC)","\n\n * Is a child with cardiac disease who is at risk for thromboembolic complications and requires at least 3 months antithrombotic anticoagulant prophylaxis\n\nEither one of the following:\n\n 1. a child with cardiac disease who has a history of cardiac shunt occlusion/thrombosis, with shunt still in place (secondary prevention).OR\n    \n    \n 2. a child with cardiac disease who requires (including those already taking, and those not yet taking) anticoagulation for primary prevention of TE.\n\nCardiac conditions known to significantly increase the risk of thrombosis (hence, indications for primary TE prevention) are defined in Antithrombotic Therapy and Prevention of Thrombosis. Some examples of cardiac conditions at risk of thrombosis are Fontan surgery, heart failure, Kawasaki disease, and Blalock-Taussig and Glenn surgery.\n\n * Is a male or female child between 1 and <18 years of age (children between 38 weeks gestational age and 1 year of age will be included in the study, however, only after the safety and efficacy data of 50 subjects between 1 and <18 years of age in the edoxaban arm have been evaluated at the end of the 3-month treatment period)\n * Has parent(s)/legal guardian(s) or legally acceptable representative who is informed and provides signed consent for the child, to participate in the study with edoxaban treatment. Pediatric participants with appropriate intellectual maturity will be required to sign an assent form in addition to the signed informed consent from the parent(s)/legal guardian(s) or any legally acceptable representative.\n * If a female subject of childbearing potential, tests negative for pregnancy at Screening and consents to avoid becoming pregnant by using a locally approved contraception method throughout the study\n\n","\n\n * Has evidence of symptomatic venous or arterial thrombosis and/or asymptomatic intracardiac thrombosis confirmed by a transthoracic echocardiogram during study screening period\n * Has mechanical heart valve(s)\n * Has active bleeding or high risk of bleeding contraindicating treatment with anticoagulant\n * Takes antithrombotic therapy (other than low-dose aspirin) that is not protocol-related\n * Administration of rifampin is prohibited during the study and subjects on concomitant use of rifampin are excluded\n * Has any hepatic disease associated with coagulopathy leading to a clinically relevant bleeding risk\n * Has estimated glomerular filtration rate (eGFR) <30% of normal for age and size\n * Has stage 2 hypertension defined as blood pressure systolic and/or diastolic confirmed >99th percentile plus 5 mmHg\n * Has thrombocytopenia or life expectancy less than three months\n * Has had Fontan procedure with a history of or signs/symptoms suggestive of protein-losing enteropathy\n * Is pregnant or breastfeeding\n * Has a contraindication to the use of heparin and/or vitamin K antagonist (VKA)\n * Has any condition that, as judged by the Investigator, would place the participant at increased risk of harm if he/she participated in the study, including contraindicated medications identified in the protocol",{"$nulls":4},"Actual","2018-01-10","Actual","Anticipated","2020-12-31","Anticipated","2020-01-01","2018-01-04","2018-01-04","2020-01-06","Yes","Children\nPediatrics\nCardiac disease with potential for thromboembolic complications\nProphylactic treatment\nAnticoagulant drugs","Interventional","Prevention","Parallel Assignment","None (Open Label)","Randomized",null,"17 Years","All",null,"No","Yes\nDe-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/",{"$nulls":3},"Yes","No",{"$nulls":17},"2017-000475-90","EudraCT Number","Number of participants with combined bleeding events within the main treatment period|Number of participants with combined bleeding events during the entire trial (from first to the last dose plus 30 days)","Combined bleeding events include major and clinically-relevant non-major (CRNM) bleeding events per International Society on Thrombosis and Haemostasis (ISTH) definition occurring within the main treatment period|Combined bleeding events include major and clinically-relevant non-major (CRNM) bleeding events per International Society on Thrombosis and Haemostasis (ISTH) definition occurring on treatment","within 4 months (3-month Main Treatment Period + 30-day follow-up)|within 13 months (3-month Main Treatment Period + 9-month Extension Period + 30-day follow-up)","Number of participants with symptomatic thromboembolic events (TE) in the systemic arterial or venous pathways|Number of participants who died as a result of TE between randomization and the date of the last dose of study drug plus 30 days|Number of participants who died as a result of any cause between randomization and the date of the last dose of study drug plus 30 days","Symptomatic thromboembolic events (TE) in the systemic arterial or venous pathways include deep vein thrombosis (DVT), pulmonary embolism (PE), stroke, intracardiac thrombus and myocardial infarction (MI)|within 13 months","within 4 months|within 13 months",{"$nulls":3},"Linz, Austria, 4020|Hamilton, Ontario, Canada, L8N 3Z5|MontrÃ©al, Quebec, Canada, H3T 1C5|Zagreb, Croatia, 10000|Zagazig, Al Sharkeya, Egypt, 44519|Alexandria, Egypt, 21131|Toulouse Cedex 9, Haute Garonne, France, 31059|Montpellier, Herault, France, 34295|Beirut, Lebanon, 166830|Paris, Paris Cedex 15, France, 75015|Budapest, Hungary, 1096|SÅ«rat, Gujarat, India, 395002|Mitra, Monjiri, Kolkata, India, 700017|Be'Er Sheva, Israel, 8410101|Beirut, Lebanon, 11-0236|Barcelona, Spain, 08035|Ankara, Turkey, 06100|Edirne, Kayseri, Turkey, 38039|London, Greater London, United Kingdom, Sw3 6Hp|Leicester, Leicestershire, United Kingdom, Le3 9Qp|Glasgow, Strathclyde, United Kingdom, G51 4Tf|Birmingham, Alabama, United States, 35233|Mesa, Arizona, United States, 85202|Los Angeles, California, United States, 90048|Gainesville, Florida, United States, 32610|Chicago, Illinois, United States, 60611|New Orleans, Louisiana, United States, 70121|Charlotte, North Carolina, United States, 28204 East Carolina Heart Institute @ EcuGreenville, North Carolina, United States, 27834|Oklahoma City, Oklahoma, United States, 73104|Charlottesville, Virginia, United States, 22903|Seattle, Washington, United States, 98105","Alabama|Arizona|California|Florida|Illinois|Louisiana|North Carolina|Oklahoma|Virginia|Washington","Austria|Canada|Croatia|Egypt|France|Hungary|India|Israel|Lebanon|Spain|Turkey|United Kingdom|United States","Kepler UniversitÃ¤tsklinikum Med Campus Iv|Ontario Mcmaster Children's Hospital|Quebec Chu Sainte-Justine|University Hospital Center Zagreb|Al Sharkeya Zagazig University Hospital|Alexandria Clinical Research Center, Faculty Of Medicine|Haute Garonne HÃ´pital Des Enfants, BÃ¢timent Modulaire|Herault Pediatric And Congenital Cardiology And Pulmonology Department; Arnaud De Villeneuve University Hospital|Hospital|Paris Cedex 15 Pediatric Cardiology Department, Hospital Necker Enfants Malades, Aphp, UniversitÃ© Paris Descartes|Gottsegen Gyorgy Orszagos Kardiologiai Intezet|Gujarat Nirmal Hospital Private Limited|Kolkata Institute Of Child Health|Soroka University Medical Center|Children's Heart Centre At The American University Of Beirut Medical Center|Hospital Universitari Vall D'Hebron|Hacettepe University Medical Faculty|Kayseri Erciyes University Medical Faculty, Department Of Children Hospital|, Greater London Royal Brompton Hospital|, Leicestershire Glenfield Hospital|, Strathclyde Ward 2B, Royal Hospital For Children|University Of Alabama At Birmingham|Cardon Childrens Medical Center|Cedars Sinai Medical Center (Ecg)|University Of Florida College Of Medicine|Ann & Robert H. Lurie Children's Hospital Of Chicago|Ochsner Medical Center|Novant Health Heart And Vascular Institute|Ou Health Sciences Center|University Of Virginia Health System|Seattle Children's Research Institute",{"$nulls":3},"Clinical Study Leader","2020-01-06","2020-05-25T16:36:11.906","2020-05-26T17:10:42.972","NCT03395639"]
["5ecbf3fcfe30261b1a04821a","NCT03395639","2020-02-05","Daiichi Sankyo","DSNKY","Recruiting","Edoxaban for Prevention of Blood Vessels Being Blocked by Clots (Thrombotic Events) in Children at Risk Because of Cardiac Disease","Edoxaban|Enoxaparin sodium|Heparin|Warfarin","FXa Inhibitor|AT III Activator|Thrombin Inhibitor|Heparin Inhibitor|Vitamin K Antagonist","No",null,"No",null,"Phase 3",2,150,"Anticipated","2018-05-15","2020-12-31",{"$nulls":5},"A committee will judge the safety and effectiveness of edoxaban and the regular treatment (standard of care).\n\nAll children in the study will receive free treatment. They will have a 2 in 3 chance to receive edoxaban, and a 1 in 3 chance to receive the standard of care for preventing blood clots.\n\nThe study will find out if edoxaban is safer and more effective than the standard of care.","The primary objective is to compare the safety of edoxaban with the standard of care (SOC) in pediatric subjects with cardiac diseases at risk of thromboembolic complications who need primary or secondary anticoagulant prophylaxis with regard to the combination of major and clinically relevant non-major (CRNM) bleeding per International Society on Thrombosis and Haemostasis [ISTH] definition.\n\nThe key secondary objective is to compare the efficacy of edoxaban against SOC with regard to the development of symptomatic thromboembolic events (TE) in the systemic arterial or venous pathways including deep vein thrombosis (DVT), pulmonary embolism (PE), stroke, intracardiac thrombus and myocardial infarction (MI), and asymptomatic intracardiac thrombus identified by cardiac imaging.","An Open-label, Randomised, Parallel-group, Multicentre, Observational Trial to Evaluate Safety and Efficacy of Edoxaban Tosylate in Children From 38 Weeks Gestational Age to Less Than 18 Years of Age With Cardiac Diseases at Risk of Thromboembolic Events","DU176b-C-U313","Cardiac Disease","Myocardial Infarction|Embolism|Pulmonary Embolism|Thrombosis|Stroke|Embolism and Thrombosis|Venous Thrombosis|Pulmonary Infarction","Heart Diseases|Vascular Diseases|Lung Diseases|Central Nervous System Diseases","Cardiovascular|Respiratory|Central Nervous System","Experimental|Active Comparator","Edoxaban|Standard of Care (SOC)","Two out of three participants will be randomized for treatment with edoxaban solution or tablets|One out of three participants will be randomized for treatment with the institution's SOC regimen","Drug","Edoxaban|Standard of Care (SOC)","Edoxaban 15 mg or 30 mg tablets for participants 12 to <18 years of age, or 60 mg edoxaban suspension (dosed as mg/kg) for participants under 12 years of age (and optionally, 12 or older), for oral administration|Standard of care could include low molecular weight heparin (LMWH) and/or VKA according to the clinical site's SOC treatment regimen","Lixiana | Savaysa|Warfarin/heparin | Enoxaparin","Edoxaban|Standard of Care (SOC)","\n\n * Is a child with cardiac disease who is at risk for thromboembolic complications and requires at least 3 months antithrombotic anticoagulant prophylaxis\n\nEither one of the following:\n\n 1. a child with cardiac disease who has a history of cardiac shunt occlusion/thrombosis, with shunt still in place (secondary prevention).OR\n    \n    \n 2. a child with cardiac disease who requires (including those already taking, and those not yet taking) anticoagulation for primary prevention of TE.\n\nCardiac conditions known to significantly increase the risk of thrombosis (hence, indications for primary TE prevention) are defined in Antithrombotic Therapy and Prevention of Thrombosis. Some examples of cardiac conditions at risk of thrombosis are Fontan surgery, heart failure, Kawasaki disease, and Blalock-Taussig and Glenn surgery.\n\n * Is a male or female child between 1 and <18 years of age (children between 38 weeks gestational age and 1 year of age will be included in the study, however, only after the safety and efficacy data of 50 subjects between 1 and <18 years of age in the edoxaban arm have been evaluated at the end of the 3-month treatment period)\n * Has parent(s)/legal guardian(s) or legally acceptable representative who is informed and provides signed consent for the child, to participate in the study with edoxaban treatment. Pediatric participants with appropriate intellectual maturity will be required to sign an assent form in addition to the signed informed consent from the parent(s)/legal guardian(s) or any legally acceptable representative.\n * If a female subject of childbearing potential, tests negative for pregnancy at Screening and consents to avoid becoming pregnant by using a locally approved contraception method throughout the study\n\n","\n\n * Has evidence of symptomatic venous or arterial thrombosis and/or asymptomatic intracardiac thrombosis confirmed by a transthoracic echocardiogram during study screening period\n * Has mechanical heart valve(s)\n * Has active bleeding or high risk of bleeding contraindicating treatment with anticoagulant\n * Takes antithrombotic therapy (other than low-dose aspirin) that is not protocol-related\n * Administration of rifampin is prohibited during the study and subjects on concomitant use of rifampin are excluded\n * Has any hepatic disease associated with coagulopathy leading to a clinically relevant bleeding risk\n * Has estimated glomerular filtration rate (eGFR) <30% of normal for age and size\n * Has stage 2 hypertension defined as blood pressure systolic and/or diastolic confirmed >99th percentile plus 5 mmHg\n * Has thrombocytopenia or life expectancy less than three months\n * Has had Fontan procedure with a history of or signs/symptoms suggestive of protein-losing enteropathy\n * Is pregnant or breastfeeding\n * Has a contraindication to the use of heparin and/or vitamin K antagonist (VKA)\n * Has any condition that, as judged by the Investigator, would place the participant at increased risk of harm if he/she participated in the study, including contraindicated medications identified in the protocol",{"$nulls":4},"Actual","2018-01-10","Actual","Anticipated","2020-12-31","Anticipated","2020-02-01","2018-01-04","2018-01-04","2020-02-03","Yes","Children\nPediatrics\nCardiac disease with potential for thromboembolic complications\nProphylactic treatment\nAnticoagulant drugs","Interventional","Prevention","Parallel Assignment","None (Open Label)","Randomized",null,"17 Years","All",null,"No","Yes\nDe-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/",{"$nulls":3},"Yes","No",{"$nulls":17},"2017-000475-90","EudraCT Number","Number of participants with combined bleeding events within the main treatment period|Number of participants with combined bleeding events during the entire trial (from first to the last dose plus 30 days)","Combined bleeding events include major and clinically-relevant non-major (CRNM) bleeding events per International Society on Thrombosis and Haemostasis (ISTH) definition occurring within the main treatment period|Combined bleeding events include major and clinically-relevant non-major (CRNM) bleeding events per International Society on Thrombosis and Haemostasis (ISTH) definition occurring on treatment","within 4 months (3-month Main Treatment Period + 30-day follow-up)|within 13 months (3-month Main Treatment Period + 9-month Extension Period + 30-day follow-up)","Number of participants with symptomatic thromboembolic events (TE) in the systemic arterial or venous pathways|Number of participants who died as a result of TE between randomization and the date of the last dose of study drug plus 30 days|Number of participants who died as a result of any cause between randomization and the date of the last dose of study drug plus 30 days","Symptomatic thromboembolic events (TE) in the systemic arterial or venous pathways include deep vein thrombosis (DVT), pulmonary embolism (PE), stroke, intracardiac thrombus and myocardial infarction (MI)|within 13 months","within 4 months|within 13 months","CTRinfo@dsi.com","Daiichi Sankyo Contact for Clinical Trial Information","908-992-6400","Linz, Austria, 4020|Hamilton, Ontario, Canada, L8N 3Z5|MontrÃ©al, Quebec, Canada, H3T 1C5|Zagreb, Croatia, 10000|Zagazig, Al Sharkeya, Egypt, 44519|Alexandria, Egypt, 21131|Toulouse Cedex 9, Haute Garonne, France, 31059|Montpellier, Herault, France, 34295|Beirut, Lebanon, 166830|Paris, Paris Cedex 15, France, 75015|Budapest, Hungary, 1096|SÅ«rat, Gujarat, India, 395002|Mitra, Monjiri, Kolkata, India, 700017|Be'Er Sheva, Israel, 8410101|Beirut, Lebanon, 11-0236|Barcelona, Spain, 08035|Ankara, Turkey, 06100|Edirne, Kayseri, Turkey, 38039|London, Greater London, United Kingdom, Sw3 6Hp|Leicester, Leicestershire, United Kingdom, Le3 9Qp|Glasgow, Strathclyde, United Kingdom, G51 4Tf|Birmingham, Alabama, United States, 35233|Mesa, Arizona, United States, 85202|Los Angeles, California, United States, 90048|Gainesville, Florida, United States, 32610|Chicago, Illinois, United States, 60611|New Orleans, Louisiana, United States, 70121|Charlotte, North Carolina, United States, 28204 East Carolina Heart Institute @ EcuGreenville, North Carolina, United States, 27834|Oklahoma City, Oklahoma, United States, 73104|Charlottesville, Virginia, United States, 22903|Seattle, Washington, United States, 98105","Alabama|Arizona|California|Florida|Illinois|Louisiana|North Carolina|Oklahoma|Virginia|Washington","Austria|Canada|Croatia|Egypt|France|Hungary|India|Israel|Lebanon|Spain|Turkey|United Kingdom|United States","Kepler UniversitÃ¤tsklinikum Med Campus Iv|Ontario Mcmaster Children's Hospital|Quebec Chu Sainte-Justine|University Hospital Center Zagreb|Al Sharkeya Zagazig University Hospital|Alexandria Clinical Research Center, Faculty Of Medicine|Haute Garonne HÃ´pital Des Enfants, BÃ¢timent Modulaire|Herault Pediatric And Congenital Cardiology And Pulmonology Department; Arnaud De Villeneuve University Hospital|Hospital|Paris Cedex 15 Pediatric Cardiology Department, Hospital Necker Enfants Malades, Aphp, UniversitÃ© Paris Descartes|Gottsegen Gyorgy Orszagos Kardiologiai Intezet|Gujarat Nirmal Hospital Private Limited|Kolkata Institute Of Child Health|Soroka University Medical Center|Children's Heart Centre At The American University Of Beirut Medical Center|Hospital Universitari Vall D'Hebron|Hacettepe University Medical Faculty|Kayseri Erciyes University Medical Faculty, Department Of Children Hospital|, Greater London Royal Brompton Hospital|, Leicestershire Glenfield Hospital|, Strathclyde Ward 2B, Royal Hospital For Children|University Of Alabama At Birmingham|Cardon Childrens Medical Center|Cedars Sinai Medical Center (Ecg)|University Of Florida College Of Medicine|Ann & Robert H. Lurie Children's Hospital Of Chicago|Ochsner Medical Center|Novant Health Heart And Vascular Institute|Ou Health Sciences Center|University Of Virginia Health System|Seattle Children's Research Institute",{"$nulls":3},"Clinical Study Leader","2020-02-03","2020-05-25T16:36:12.165","2020-05-26T17:10:42.972","NCT03395639"]
["5ecbf3fd307e3d1b1f8d9cac","NCT03395808","2018-01-10","Avenue","ATXI","Recruiting","Evaluate Safety of Tramadol in the Management of Postoperative Pain Following Surgery","Tramadol","OPRM Agonist|NRI Antagonist","No",null,"No",null,"Phase 3",1,250,"Anticipated","2017-12-22","2019-06-30",{"$nulls":5},"The study evaluates the safety of IV tramadol managing post-operative pain following surgery.","(Non-clinical summary) Tramadol is a centrally-acting synthetic analgesic of the aminocyclohexanol group with opioidlike effects. Tramadol is extensively metabolized following administration, which results in a number of enantiomeric metabolites that display different opioid-receptor binding properties, and monoaminergic reuptake inhibition.","A Phase 3, Multicenter, Single-Arm, Open-Label Study to Evaluate the Safety of Tramadol Infusion (AVE-901) in the Management of Post-Operative Pain Following Surgery","AVE-901-104","Pain Management","Pain, Postoperative","Neurologic Manifestations","Central Nervous System",null,"AVE-901 50mg","IV Tramadol","Drug","Tramadol","IV; 50 mg given at Hours 0, 0.5, 1, 2, 3, 4 and every 4 hours thereafter, for a total of up to 43 doses",null,"AVE-901 50mg","\n\n * The patient is male or female 18-75 years of age\n * Willing to give consent and able to understand the study procedures\n * Female patients must be of non-childbearing potential or be practicing a highly effective contraption\n * The patient must be willing to be housed in a healthcare facility and able to receive parenteral analgesia for at least 24 hours after surgery\n * The patient meets definition of American Society of Anesthesiologists (ASA) Physical Class 1, or 2.\n\n","\n\n * The patient has used chronic opioid therapy, defined as >= 20 MEQs of morphine per day >=3 days out of 7 days over the past 4 weeks.\n * The patient has a recent (within 2 years) and/or current history of alcohol, opiate or tranquilizer abuse or dependence.\n * The patient is taking herbal or dietary supplements or medications that are moderate or strong inhibitors of CYP2D6 or CYP3A4 (e.g., fluoxetine, paroxetine, amitriptyline, quinidine, ketoconazole, erythromycin, grapefruit juice) or inducers of CYP3A4 (e.g., carbamazepine, rifampin, St. John's Wort) and cannot go through a minimum washout period of 7 days prior to surgery.\n * The patient has a history of epilepsy, is susceptible to seizures.\n * The patient cannot be withdrawn from medications (at least 7 days prior to surgery) that may lower the seizure threshold (e.g. anti-psychotic agents, MAOI inhibitors) or which increase serotonergic tone (e.g. selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, triptans, amphetamines).\n * The patient has had a recent (within 6 months) cardiovascular event or clinically significant abnormal ECG finding at screening.\n * The patient has a history of Long QT Syndrome or a relative with this condition.\n * The patient has expressed suicidal ideation within the past 3 months or is considered to be at risk of suicide.\n * The patient is morbidly obese (body mass index [BMI] â‰¥ 40 kg/m2) or has documented sleep apnea requiring CPAP or other treatment.\n * Female patient is pregnant and/or undergoing a pregnancy-related surgery, or breastfeeding.\n * The patient has a history of cardiopulmonary, neurological or psychiatric condition that may confound the assessments of efficacy or safety.\n * The patient has cirrhosis, moderate or severe hepatic impairment or an alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value > 3X upper limit of normal (ULN) at Screening.\n * The patient has severe renal impairment or a serum creatinine value of > 2x upper limit of normal (ULN) at Screening.\n * The patient has potassium, sodium, calcium or magnesium levels outside of the normal range at Screening.\n * The patient has a hemoglobin level at screening which, in the judgment of the Investigator, is not suitable for participation in this study.",{"$nulls":4},"Actual","2018-01-10","Actual","Anticipated","2019-06-30","Anticipated","2018-01-01","2017-12-22","2018-01-04","2018-01-04","No",null,"Interventional","Other","Single Group Assignment","None (Open Label)","N/A","18 Years","75 Years","All",null,"Yes",{"$nulls":4},"Yes","No",{"$nulls":19},"Adverse events|Local tolerability of the infusion site","Reported Adverse Events|Infusion site reported Adverse Events","Up to 21 days|Up to 168 hours",{"$nulls":6},"Pasadena, California, United States, 91105","California","United States","Lotus Clinical Research",{"$nulls":4},"2018-01-04","2020-05-25T16:36:13.060","2020-05-26T17:10:42.972","NCT03395808"]
["5ecbf3fcfeab101b1553084b","NCT03395808","2018-02-08","Avenue","ATXI","Recruiting","Evaluate Safety of Tramadol in the Management of Postoperative Pain Following Surgery","Tramadol","OPRM Agonist|NRI Antagonist","No",null,"No",null,"Phase 3",1,250,"Anticipated","2017-12-22","2019-06-30",{"$nulls":5},"The study evaluates the safety of IV tramadol managing post-operative pain following surgery.","(Non-clinical summary) Tramadol is a centrally-acting synthetic analgesic of the aminocyclohexanol group with opioidlike effects. Tramadol is extensively metabolized following administration, which results in a number of enantiomeric metabolites that display different opioid-receptor binding properties, and monoaminergic reuptake inhibition.","A Phase 3, Multicenter, Single-Arm, Open-Label Study to Evaluate the Safety of Tramadol Infusion (AVE-901) in the Management of Post-Operative Pain Following Surgery","AVE-901-104","Pain Management","Pain, Postoperative","Neurologic Manifestations","Central Nervous System",null,"AVE-901 50mg","IV Tramadol","Drug","Tramadol","IV; 50 mg given at Hours 0, 2, 4, 8 and every 4 hours thereafter, for a total of up to 43 doses",null,"AVE-901 50mg","\n\n * The patient is male or female 18-75 years of age\n * Willing to give consent and able to understand the study procedures\n * Female patients must be of non-childbearing potential or be practicing a highly effective contraption\n * The patient must be willing to be housed in a healthcare facility and able to receive parenteral analgesia for at least 24 hours after surgery\n * The patient meets definition of American Society of Anesthesiologists (ASA) Physical Class 1, or 2.\n\n","\n\n * The patient has used chronic opioid therapy, defined as >= 20 MEQs of morphine per day >=3 days out of 7 days over the past 4 weeks.\n * The patient has a recent (within 2 years) and/or current history of alcohol, opiate or tranquilizer abuse or dependence.\n * The patient is taking herbal or dietary supplements or medications that are moderate or strong inhibitors of CYP2D6 or CYP3A4 (e.g., fluoxetine, paroxetine, amitriptyline, quinidine, ketoconazole, erythromycin, grapefruit juice) or inducers of CYP3A4 (e.g., carbamazepine, rifampin, St. John's Wort) and cannot go through a minimum washout period of 7 days prior to surgery.\n * The patient has a history of epilepsy, is susceptible to seizures.\n * The patient cannot be withdrawn from medications (at least 7 days prior to surgery) that may lower the seizure threshold (e.g. anti-psychotic agents, MAOI inhibitors) or which increase serotonergic tone (e.g. selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, triptans, amphetamines).\n * The patient has had a recent (within 6 months) cardiovascular event or clinically significant abnormal ECG finding at screening.\n * The patient has a history of Long QT Syndrome or a relative with this condition.\n * The patient has expressed suicidal ideation within the past 3 months or is considered to be at risk of suicide.\n * The patient is morbidly obese (body mass index [BMI] â‰¥ 40 kg/m2) or has documented sleep apnea requiring CPAP or other treatment.\n * Female patient is pregnant and/or undergoing a pregnancy-related surgery, or breastfeeding.\n * The patient has a history of cardiopulmonary, neurological or psychiatric condition that may confound the assessments of efficacy or safety.\n * The patient has cirrhosis, moderate or severe hepatic impairment or an alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value > 3X upper limit of normal (ULN) at Screening.\n * The patient has severe renal impairment or a serum creatinine value of > 2x upper limit of normal (ULN) at Screening.\n * The patient has potassium, sodium, calcium or magnesium levels outside of the normal range at Screening.\n * The patient has a hemoglobin level at screening which, in the judgment of the Investigator, is not suitable for participation in this study.",{"$nulls":4},"Actual","2018-01-10","Actual","Anticipated","2019-06-30","Anticipated","2018-02-01","2017-12-22","2018-01-04","2018-02-06","No",null,"Interventional","Other","Single Group Assignment","None (Open Label)","N/A","18 Years","75 Years","All",null,"Yes",{"$nulls":4},"Yes","No",{"$nulls":19},"Adverse events|Local tolerability of the infusion site","Reported Adverse Events|Infusion site reported Adverse Events","Up to 21 days|Up to 168 hours",{"$nulls":6},"Pasadena, California, United States, 91105","California","United States","Lotus Clinical Research",{"$nulls":4},"2018-02-06","2020-05-25T16:36:12.679","2020-05-26T17:10:42.972","NCT03395808"]
["5ecbf3fce2561b1b11905d16","NCT03395808","2019-05-09","Avenue","ATXI","Active, not recruiting","Evaluate Safety of Tramadol in the Management of Postoperative Pain Following Surgery","Tramadol","OPRM Agonist|NRI Antagonist","No",null,"No",null,"Phase 3",1,250,"Anticipated","2017-12-22","2019-06-30",{"$nulls":5},"The study evaluates the safety of IV tramadol managing post-operative pain following surgery.","(Non-clinical summary) Tramadol is a centrally-acting synthetic analgesic of the aminocyclohexanol group with opioidlike effects. Tramadol is extensively metabolized following administration, which results in a number of enantiomeric metabolites that display different opioid-receptor binding properties, and monoaminergic reuptake inhibition.","A Phase 3, Multicenter, Single-Arm, Open-Label Study to Evaluate the Safety of Tramadol Infusion (AVE-901) in the Management of Post-Operative Pain Following Surgery","AVE-901-104","Pain Management","Pain, Postoperative","Neurologic Manifestations","Central Nervous System",null,"AVE-901 50mg","IV Tramadol","Drug","Tramadol","IV; 50 mg given at Hours 0, 2, 4, 8 and every 4 hours thereafter, for a total of up to 43 doses",null,"AVE-901 50mg","\n\n * The patient is male or female 18-75 years of age\n * Willing to give consent and able to understand the study procedures\n * Female patients must be of non-childbearing potential or be practicing a highly effective contraption\n * The patient must be willing to be housed in a healthcare facility and able to receive parenteral analgesia for at least 24 hours after surgery\n * The patient meets definition of American Society of Anesthesiologists (ASA) Physical Class 1, or 2.\n\n","\n\n * The patient has used chronic opioid therapy, defined as >= 20 MEQs of morphine per day >=3 days out of 7 days over the past 4 weeks.\n * The patient has a recent (within 2 years) and/or current history of alcohol, opiate or tranquilizer abuse or dependence.\n * The patient is taking herbal or dietary supplements or medications that are moderate or strong inhibitors of CYP2D6 or CYP3A4 (e.g., fluoxetine, paroxetine, amitriptyline, quinidine, ketoconazole, erythromycin, grapefruit juice) or inducers of CYP3A4 (e.g., carbamazepine, rifampin, St. John's Wort) and cannot go through a minimum washout period of 7 days prior to surgery.\n * The patient has a history of epilepsy, is susceptible to seizures.\n * The patient cannot be withdrawn from medications (at least 7 days prior to surgery) that may lower the seizure threshold (e.g. anti-psychotic agents, MAOI inhibitors) or which increase serotonergic tone (e.g. selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, triptans, amphetamines).\n * The patient has had a recent (within 6 months) cardiovascular event or clinically significant abnormal ECG finding at screening.\n * The patient has a history of Long QT Syndrome or a relative with this condition.\n * The patient has expressed suicidal ideation within the past 3 months or is considered to be at risk of suicide.\n * The patient is morbidly obese (body mass index [BMI] â‰¥ 40 kg/m2) or has documented sleep apnea requiring CPAP or other treatment.\n * Female patient is pregnant and/or undergoing a pregnancy-related surgery, or breastfeeding.\n * The patient has a history of cardiopulmonary, neurological or psychiatric condition that may confound the assessments of efficacy or safety.\n * The patient has cirrhosis, moderate or severe hepatic impairment or an alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value > 3X upper limit of normal (ULN) at Screening.\n * The patient has severe renal impairment or a serum creatinine value of > 2x upper limit of normal (ULN) at Screening.\n * The patient has potassium, sodium, calcium or magnesium levels outside of the normal range at Screening.\n * The patient has a hemoglobin level at screening which, in the judgment of the Investigator, is not suitable for participation in this study.",{"$nulls":4},"Actual","2018-01-10","Actual","Anticipated","2019-06-30","Anticipated","2019-05-01","2017-12-22","2018-01-04","2019-05-07","No",null,"Interventional","Other","Single Group Assignment","None (Open Label)","N/A","18 Years","75 Years","All",null,"Yes",{"$nulls":4},"Yes","No",{"$nulls":19},"Adverse events|Local tolerability of the infusion site","Reported Adverse Events|Infusion site reported Adverse Events","Up to 21 days|Up to 168 hours",{"$nulls":6},"Pasadena, California, United States, 91105","California","United States","Lotus Clinical Research",{"$nulls":4},"2019-05-07","2020-05-25T16:36:12.568","2020-05-26T17:10:42.972","NCT03395808"]
["5ecbf3fefe30261b1a04821e","NCT03396250","2018-01-10","Bayer","BAYN","Not yet recruiting","A Pharmacokinetic Trial of Naproxen Sodium and Diphenhydramine Hydrochloride Soft Capsules Versus Naproxen Sodium and Diphenhydramine Hydrochloride Tablets in Healthy Adult Subjects","Diphenhydramine|Naproxen","H1 Antagonist|COX Inhibitor","No",null,"No",null,"Phase 1",2,36,"Anticipated","2018-02-11","2018-08-21","AUC","Area Under The Curve",{"$nulls":3},"To evaluate the relative bioavailability of Naproxen Sodium 220 mg and diphenhydramine hydrochloride (DPH HCL) 25 mg soft capsules (Test) versus Naproxen Sodium 220 mg and diphenhydramine hydrochloride 25 mg tablets (Reference) after a single oral administration under fasted condition in healthy adults subjects.\n\nTo assess the safety and tolerability of the investigational products in terms of advent events (AEs) and clinical parameters.",null,"An Open Label Crossover Pharmacokinetic Trial of Naproxen Sodium and Diphenhydramine Hydrochloride Soft Capsules Versus Naproxen Sodium and Diphenhydramine Hydrochloride Tablets in Healthy Adult Subjects Under Fasted Conditions",17934,"Pain","Healthy Volunteers|Pain Unspecified","Healthy|Neurologic Manifestations","Healthy|Central Nervous System","Experimental","Test product + Reference product|Reference product + Test product","Each treatment sequence consists of two treatment periods with each period consisting of 4 days starting with an overnight fast of at least 10 hours followed by a single dose of study drug administration the morning of Day 1, then a 72-hour PK (Pharmacokinetic) blood sampling period. The two drug administrations are separated by a 7 calendar days washout phase.|Each treatment sequence consists of two treatment periods with each period consisting of 4 days starting with an overnight fast of at least 10 hours followed by a single dose of study drug administration the morning of Day 1, then a 72-hour PK blood sampling period. The two drug administrations are separated by a 7 calendar days washout phase.","Drug","Naproxen sodium and diphenhydramine hydrochloride soft capsules|Naproxen sodium and diphenhydramine hydrochloride coated tablets (Aleve, PMBAY98-7111)","Single oral administration of Naproxen sodium 220 mg/DPH HCl 25mg (2 capsules)|Single administration of Naproxen sodium 220 mg/DPH HCl 25mg (2 tablets)",null,"Test product + Reference product|Reference product + Test product","\n\n * Healthy adult men or women\n * Age 18 to 55 years inclusive;\n * Body mass index 18.5 to 30.0 kg/m2 inclusive\n\n","\n\n * History of hypersensitivity symptoms with the use of naproxen/naproxen sodium, diphenhydramine hydrochloride/citrate, acetylsalicylic acid, other Nonsteroidal anti-inflammatory drugs (NSAIDs) or similar pharmacological agents or components of the products;\n * Females who are pregnant or lactating;\n * Vegetarian or restricted diet (e.g., gluten-free);\n * Any active disease, acute or chronic;\n * Have taken naproxen/naproxen sodium, DPH HCl or diphenhydramine citrate, DPH HCl or diphenhydramine citrate-containing products, acetylsalicylic acid (ASA), ASA-containing products, acetaminophen, ibuprofen, any other NSAID (Over-the -counter [OTC] or prescription) or NSAID containing products, xanthines, antihistamines or caffeine-containing products (e.g. coffee, tea and chocolate) 7 days prior to dosing or during the Dosing Periods, other than trial treatment;\n * Use of any over-the-counter or prescription medications, vitamins or herbal supplements (except acceptable forms of birth control) within 7 days prior to dosing or throughout the trial, unless in the opinion of the Investigator, the medication will not interfere with the trial procedures, data integrity, or compromise the safety of the subject;\n * Positive test for Human immunodeficiency virus (HIV) antibodies and antigens;\n * Positive test for hepatitis B surface antigen (HBsAg) test;\n * Positive test for anti-hepatitis C virus (Anti-HCV) antibodies;\n * In the judgment of the investigator, any need of other medication during the trial besides the test and reference study medication;\n * Recently had (past 30 days) or plan to have surgery, an invasive procedure, tattoos or piercings during the trial or within 2 weeks after treatment;\n * More than moderate alcohol consumption (>40 g of alcohol regularly per day);\n * Positive alcohol or drug screen at Screening or on Day -1 of each dosing period.\n * Any history or suspicion of barbiturate, amphetamine, benzodiazepine, cocaine, opiates, methamphetamine or cannabis abuse;\n * Loss of blood in excess of 50 mL to 499 mL within 30 days or 500 ml within 56 days of the first dose of trial treatment (e.g., donation, plasmapheresis or injury);\n * Excessive sports or sauna within 5 days before start of the treatment phase and unwilling to abstain during the trial;\n * Have a platelet count <150,000/mm3 and in the judgment of the investigator, presents a significant bleeding risk;\n * History of gastrointestinal bleeding or perforation, related to previous NSAID therapy. Active, or history of recurrent peptic ulcer/hemorrhage (two or more distinct episodes of proven ulceration or bleeding);\n * Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic diseases (including glaucoma or benign prostatic hypertrophy) or malignancies or any other disease or condition which could influence the metabolism of the drug;",{"$nulls":4},"Actual","2018-01-10","Actual","Anticipated","2018-08-21","Anticipated","2017-12-01","2018-01-05","2018-01-05","2018-01-05","No",null,"Interventional","Treatment","Crossover Assignment","None (Open Label)","Randomized","18 Years","55 Years","All",null,"Yes",{"$nulls":4},"Yes","No",{"$nulls":19},"AUC|AUC(0-tlast)|Cmax","Area under the concentration vs. time curve from zero to infinity after single (first) dose|Area under plasma concentration vs. time curve from zero to last data point >LLOQ (lower limit of quantitation), calculated up by linear trapezoidal rule, down by logarithmic trapezoidal rule|Maximum observed drug concentration, directly observed from analytical data","Within 30 minutes prior to dosing (baseline) 10, 20, 30, 45, 60 minutes and 1 hour 20 minutes, 1 hour 40 minutes, 2, 2 hours 30 minutes, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48 and 72 hours post-dose","Number of adverse events as a measure of safety and tolerability","Up to 5 weeks",null,"clinical-trials-contact@bayer.com","Bayer Clinical Trials Contact","(+) 1-888-8422937","San Antonio, Texas, United States, 78219","Texas","United States","Icon Development Solutions, Llc",{"$nulls":3},"Bayer Study Director","2018-01-05","2020-05-25T16:36:14.962","2020-05-26T17:10:42.972","NCT03396250"]
["5ecbf3fefeab101b1553084e","NCT03396250","2018-02-05","Bayer","BAYN","Not yet recruiting","A Pharmacokinetic Trial of Naproxen Sodium and Diphenhydramine Hydrochloride Soft Capsules Versus Naproxen Sodium and Diphenhydramine Hydrochloride Tablets in Healthy Adult Subjects","Diphenhydramine|Naproxen","H1 Antagonist|COX Inhibitor","No",null,"No",null,"Phase 1",2,36,"Anticipated","2018-02-11","2018-08-21","AUC","Area Under The Curve",{"$nulls":3},"To evaluate the relative bioavailability of Naproxen Sodium 220 mg and diphenhydramine hydrochloride (DPH HCL) 25 mg soft capsules (Test) versus Naproxen Sodium 220 mg and diphenhydramine hydrochloride 25 mg tablets (Reference) after a single oral administration under fasted condition in healthy adults subjects.\n\nTo assess the safety and tolerability of the investigational products in terms of advent events (AEs) and clinical parameters.",null,"An Open Label Crossover Pharmacokinetic Trial of Naproxen Sodium and Diphenhydramine Hydrochloride Soft Capsules Versus Naproxen Sodium and Diphenhydramine Hydrochloride Tablets in Healthy Adult Subjects Under Fasted Conditions",17934,"Pain","Healthy Volunteers|Pain Unspecified","Healthy|Neurologic Manifestations","Healthy|Central Nervous System","Experimental","Test product + Reference product|Reference product + Test product","Each treatment sequence consists of two treatment periods with each period consisting of 4 days starting with an overnight fast of at least 10 hours followed by a single dose of study drug administration the morning of Day 1, then a 72-hour PK (Pharmacokinetic) blood sampling period. The two drug administrations are separated by a 7 calendar days washout phase.|Each treatment sequence consists of two treatment periods with each period consisting of 4 days starting with an overnight fast of at least 10 hours followed by a single dose of study drug administration the morning of Day 1, then a 72-hour PK blood sampling period. The two drug administrations are separated by a 7 calendar days washout phase.","Drug","Naproxen sodium and diphenhydramine hydrochloride soft capsules|Naproxen sodium and diphenhydramine hydrochloride coated tablets (Aleve, PMBAY98-7111)","Single oral administration of Naproxen sodium 220 mg/DPH HCl 25mg (2 capsules)|Single administration of Naproxen sodium 220 mg/DPH HCl 25mg (2 tablets)",null,"Test product + Reference product|Reference product + Test product","\n\n * Healthy adult men or women\n * Age 18 to 55 years inclusive;\n * Body mass index 18.5 to 30.0 kg/m2 inclusive\n\n","\n\n * History of hypersensitivity symptoms with the use of naproxen/naproxen sodium, diphenhydramine hydrochloride/citrate, acetylsalicylic acid, other Nonsteroidal anti-inflammatory drugs (NSAIDs) or similar pharmacological agents or components of the products;\n * Females who are pregnant or lactating;\n * Vegetarian or restricted diet (e.g., gluten-free);\n * Any active disease, acute or chronic;\n * Have taken naproxen/naproxen sodium, DPH HCl or diphenhydramine citrate, DPH HCl or diphenhydramine citrate-containing products, acetylsalicylic acid (ASA), ASA-containing products, acetaminophen, ibuprofen, any other NSAID (Over-the -counter [OTC] or prescription) or NSAID containing products, xanthines, antihistamines or caffeine-containing products (e.g. coffee, tea and chocolate) 7 days prior to dosing or during the Dosing Periods, other than trial treatment;\n * Use of any over-the-counter or prescription medications, vitamins or herbal supplements (except acceptable forms of birth control) within 7 days prior to dosing or throughout the trial, unless in the opinion of the Investigator, the medication will not interfere with the trial procedures, data integrity, or compromise the safety of the subject;\n * Positive test for Human immunodeficiency virus (HIV) antibodies and antigens;\n * Positive test for hepatitis B surface antigen (HBsAg) test;\n * Positive test for anti-hepatitis C virus (Anti-HCV) antibodies;\n * In the judgment of the investigator, any need of other medication during the trial besides the test and reference study medication;\n * Recently had (past 30 days) or plan to have surgery, an invasive procedure, tattoos or piercings during the trial or within 2 weeks after treatment;\n * More than moderate alcohol consumption (>40 g of alcohol regularly per day);\n * Positive alcohol or drug screen at Screening or on Day -1 of each dosing period.\n * Any history or suspicion of barbiturate, amphetamine, benzodiazepine, cocaine, opiates, methamphetamine or cannabis abuse;\n * Loss of blood in excess of 50 mL to 499 mL within 30 days or 500 ml within 56 days of the first dose of trial treatment (e.g., donation, plasmapheresis or injury);\n * Excessive sports or sauna within 5 days before start of the treatment phase and unwilling to abstain during the trial;\n * Have a platelet count <150,000/mm3 and in the judgment of the investigator, presents a significant bleeding risk;\n * History of gastrointestinal bleeding or perforation, related to previous NSAID therapy. Active, or history of recurrent peptic ulcer/hemorrhage (two or more distinct episodes of proven ulceration or bleeding);\n * Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic diseases (including glaucoma or benign prostatic hypertrophy) or malignancies or any other disease or condition which could influence the metabolism of the drug;",{"$nulls":4},"Actual","2018-01-10","Actual","Anticipated","2018-08-21","Anticipated","2018-02-01","2018-01-05","2018-01-05","2018-02-02","No",null,"Interventional","Treatment","Crossover Assignment","None (Open Label)","Randomized","18 Years","55 Years","All",null,"Yes",{"$nulls":4},"Yes","No",{"$nulls":19},"AUC|AUC(0-tlast)|Cmax","Area under the concentration vs. time curve from zero to infinity after single (first) dose|Area under plasma concentration vs. time curve from zero to last data point >LLOQ (lower limit of quantitation), calculated up by linear trapezoidal rule, down by logarithmic trapezoidal rule|Maximum observed drug concentration, directly observed from analytical data","Within 30 minutes prior to dosing (baseline) 10, 20, 30, 45, 60 minutes and 1 hour 20 minutes, 1 hour 40 minutes, 2, 2 hours 30 minutes, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48 and 72 hours post-dose","Number of adverse events as a measure of safety and tolerability","Up to 5 weeks",null,"clinical-trials-contact@bayer.com","Bayer Clinical Trials Contact","(+) 1-888-8422937","San Antonio, Texas, United States, 78219","Texas","United States","Icon Development Solutions, Llc",{"$nulls":3},"Bayer Study Director","2018-02-02","2020-05-25T16:36:14.734","2020-05-26T17:10:42.972","NCT03396250"]
["5ecbf3ff11702c1b1b916a2f","NCT03396250","2018-03-08","Bayer","BAYN","Recruiting","A Pharmacokinetic Trial of Naproxen Sodium and Diphenhydramine Hydrochloride Soft Capsules Versus Naproxen Sodium and Diphenhydramine Hydrochloride Tablets in Healthy Adult Subjects","Diphenhydramine|Naproxen","H1 Antagonist|COX Inhibitor","No",null,"No",null,"Phase 1",2,36,"Anticipated","2018-02-12","2018-08-21","AUC","Area Under The Curve",{"$nulls":3},"To evaluate the relative bioavailability of Naproxen Sodium 220 mg and diphenhydramine hydrochloride (DPH HCL) 25 mg soft capsules (Test) versus Naproxen Sodium 220 mg and diphenhydramine hydrochloride 25 mg tablets (Reference) after a single oral administration under fasted condition in healthy adults subjects.\n\nTo assess the safety and tolerability of the investigational products in terms of advent events (AEs) and clinical parameters.",null,"An Open Label Crossover Pharmacokinetic Trial of Naproxen Sodium and Diphenhydramine Hydrochloride Soft Capsules Versus Naproxen Sodium and Diphenhydramine Hydrochloride Tablets in Healthy Adult Subjects Under Fasted Conditions",17934,"Pain","Healthy Volunteers|Pain Unspecified","Healthy|Neurologic Manifestations","Healthy|Central Nervous System","Experimental","Test product + Reference product|Reference product + Test product","Each treatment sequence consists of two treatment periods with each period consisting of 4 days starting with an overnight fast of at least 10 hours followed by a single dose of study drug administration the morning of Day 1, then a 72-hour PK (Pharmacokinetic) blood sampling period. The two drug administrations are separated by a 7 calendar days washout phase.|Each treatment sequence consists of two treatment periods with each period consisting of 4 days starting with an overnight fast of at least 10 hours followed by a single dose of study drug administration the morning of Day 1, then a 72-hour PK blood sampling period. The two drug administrations are separated by a 7 calendar days washout phase.","Drug","Naproxen sodium and diphenhydramine hydrochloride soft capsules|Naproxen sodium and diphenhydramine hydrochloride coated tablets (Aleve, PMBAY98-7111)","Single oral administration of Naproxen sodium 220 mg/DPH HCl 25mg (2 capsules)|Single administration of Naproxen sodium 220 mg/DPH HCl 25mg (2 tablets)",null,"Test product + Reference product|Reference product + Test product","\n\n * Healthy adult men or women\n * Age 18 to 55 years inclusive;\n * Body mass index 18.5 to 30.0 kg/m2 inclusive\n\n","\n\n * History of hypersensitivity symptoms with the use of naproxen/naproxen sodium, diphenhydramine hydrochloride/citrate, acetylsalicylic acid, other Nonsteroidal anti-inflammatory drugs (NSAIDs) or similar pharmacological agents or components of the products;\n * Females who are pregnant or lactating;\n * Vegetarian or restricted diet (e.g., gluten-free);\n * Any active disease, acute or chronic;\n * Have taken naproxen/naproxen sodium, DPH HCl or diphenhydramine citrate, DPH HCl or diphenhydramine citrate-containing products, acetylsalicylic acid (ASA), ASA-containing products, acetaminophen, ibuprofen, any other NSAID (Over-the -counter [OTC] or prescription) or NSAID containing products, xanthines, antihistamines or caffeine-containing products (e.g. coffee, tea and chocolate) 7 days prior to dosing or during the Dosing Periods, other than trial treatment;\n * Use of any over-the-counter or prescription medications, vitamins or herbal supplements (except acceptable forms of birth control) within 7 days prior to dosing or throughout the trial, unless in the opinion of the Investigator, the medication will not interfere with the trial procedures, data integrity, or compromise the safety of the subject;\n * Positive test for Human immunodeficiency virus (HIV) antibodies and antigens;\n * Positive test for hepatitis B surface antigen (HBsAg) test;\n * Positive test for anti-hepatitis C virus (Anti-HCV) antibodies;\n * In the judgment of the investigator, any need of other medication during the trial besides the test and reference study medication;\n * Recently had (past 30 days) or plan to have surgery, an invasive procedure, tattoos or piercings during the trial or within 2 weeks after treatment;\n * More than moderate alcohol consumption (>40 g of alcohol regularly per day);\n * Positive alcohol or drug screen at Screening or on Day -1 of each dosing period.\n * Any history or suspicion of barbiturate, amphetamine, benzodiazepine, cocaine, opiates, methamphetamine or cannabis abuse;\n * Loss of blood in excess of 50 mL to 499 mL within 30 days or 500 ml within 56 days of the first dose of trial treatment (e.g., donation, plasmapheresis or injury);\n * Excessive sports or sauna within 5 days before start of the treatment phase and unwilling to abstain during the trial;\n * Have a platelet count <150,000/mm3 and in the judgment of the investigator, presents a significant bleeding risk;\n * History of gastrointestinal bleeding or perforation, related to previous NSAID therapy. Active, or history of recurrent peptic ulcer/hemorrhage (two or more distinct episodes of proven ulceration or bleeding);\n * Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic diseases (including glaucoma or benign prostatic hypertrophy) or malignancies or any other disease or condition which could influence the metabolism of the drug;",{"$nulls":4},"Actual","2018-01-10","Actual","Anticipated","2018-08-21","Anticipated","2018-03-01","2018-01-05","2018-01-05","2018-03-06","No",null,"Interventional","Treatment","Crossover Assignment","None (Open Label)","Randomized","18 Years","55 Years","All",null,"Yes",{"$nulls":4},"Yes","No",{"$nulls":19},"AUC|AUC(0-tlast)|Cmax","Area under the concentration vs. time curve from zero to infinity after single (first) dose|Area under plasma concentration vs. time curve from zero to last data point >LLOQ (lower limit of quantitation), calculated up by linear trapezoidal rule, down by logarithmic trapezoidal rule|Maximum observed drug concentration, directly observed from analytical data","Within 30 minutes prior to dosing (baseline) 10, 20, 30, 45, 60 minutes and 1 hour 20 minutes, 1 hour 40 minutes, 2, 2 hours 30 minutes, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48 and 72 hours post-dose","Number of adverse events as a measure of safety and tolerability","Up to 5 weeks",null,"clinical-trials-contact@bayer.com","Bayer Clinical Trials Contact","(+) 1-888-8422937","San Antonio, Texas, United States, 78219","Texas","United States","Icon Development Solutions, Llc",{"$nulls":3},"Bayer Study Director","2018-03-06","2020-05-25T16:36:15.010","2020-05-26T17:10:42.972","NCT03396250"]
["5ecbf3ffe2561b1b11905d1a","NCT03396250","2018-04-05","Bayer","BAYN","Completed","A Pharmacokinetic Trial of Naproxen Sodium and Diphenhydramine Hydrochloride Soft Capsules Versus Naproxen Sodium and Diphenhydramine Hydrochloride Tablets in Healthy Adult Subjects","Diphenhydramine|Naproxen","H1 Antagonist|COX Inhibitor","No",null,"No",null,"Phase 1",2,36,"Actual","2018-02-12","2018-03-19","AUC","Area Under The Curve",{"$nulls":3},"To evaluate the relative bioavailability of Naproxen Sodium 220 mg and diphenhydramine hydrochloride (DPH HCL) 25 mg soft capsules (Test) versus Naproxen Sodium 220 mg and diphenhydramine hydrochloride 25 mg tablets (Reference) after a single oral administration under fasted condition in healthy adults subjects.\n\nTo assess the safety and tolerability of the investigational products in terms of advent events (AEs) and clinical parameters.",null,"An Open Label Crossover Pharmacokinetic Trial of Naproxen Sodium and Diphenhydramine Hydrochloride Soft Capsules Versus Naproxen Sodium and Diphenhydramine Hydrochloride Tablets in Healthy Adult Subjects Under Fasted Conditions",17934,"Pain","Healthy Volunteers|Pain Unspecified","Healthy|Neurologic Manifestations","Healthy|Central Nervous System","Experimental","Test product + Reference product|Reference product + Test product","Each treatment sequence consists of two treatment periods with each period consisting of 4 days starting with an overnight fast of at least 10 hours followed by a single dose of study drug administration the morning of Day 1, then a 72-hour PK (Pharmacokinetic) blood sampling period. The two drug administrations are separated by a 7 calendar days washout phase.|Each treatment sequence consists of two treatment periods with each period consisting of 4 days starting with an overnight fast of at least 10 hours followed by a single dose of study drug administration the morning of Day 1, then a 72-hour PK blood sampling period. The two drug administrations are separated by a 7 calendar days washout phase.","Drug","Naproxen sodium and diphenhydramine hydrochloride soft capsules|Naproxen sodium and diphenhydramine hydrochloride coated tablets (Aleve, PMBAY98-7111)","Single oral administration of Naproxen sodium 220 mg/DPH HCl 25mg (2 capsules)|Single administration of Naproxen sodium 220 mg/DPH HCl 25mg (2 tablets)",null,"Test product + Reference product|Reference product + Test product","\n\n * Healthy adult men or women\n * Age 18 to 55 years inclusive;\n * Body mass index 18.5 to 30.0 kg/m2 inclusive\n\n","\n\n * History of hypersensitivity symptoms with the use of naproxen/naproxen sodium, diphenhydramine hydrochloride/citrate, acetylsalicylic acid, other Nonsteroidal anti-inflammatory drugs (NSAIDs) or similar pharmacological agents or components of the products;\n * Females who are pregnant or lactating;\n * Vegetarian or restricted diet (e.g., gluten-free);\n * Any active disease, acute or chronic;\n * Have taken naproxen/naproxen sodium, DPH HCl or diphenhydramine citrate, DPH HCl or diphenhydramine citrate-containing products, acetylsalicylic acid (ASA), ASA-containing products, acetaminophen, ibuprofen, any other NSAID (Over-the -counter [OTC] or prescription) or NSAID containing products, xanthines, antihistamines or caffeine-containing products (e.g. coffee, tea and chocolate) 7 days prior to dosing or during the Dosing Periods, other than trial treatment;\n * Use of any over-the-counter or prescription medications, vitamins or herbal supplements (except acceptable forms of birth control) within 7 days prior to dosing or throughout the trial, unless in the opinion of the Investigator, the medication will not interfere with the trial procedures, data integrity, or compromise the safety of the subject;\n * Positive test for Human immunodeficiency virus (HIV) antibodies and antigens;\n * Positive test for hepatitis B surface antigen (HBsAg) test;\n * Positive test for anti-hepatitis C virus (Anti-HCV) antibodies;\n * In the judgment of the investigator, any need of other medication during the trial besides the test and reference study medication;\n * Recently had (past 30 days) or plan to have surgery, an invasive procedure, tattoos or piercings during the trial or within 2 weeks after treatment;\n * More than moderate alcohol consumption (>40 g of alcohol regularly per day);\n * Positive alcohol or drug screen at Screening or on Day -1 of each dosing period.\n * Any history or suspicion of barbiturate, amphetamine, benzodiazepine, cocaine, opiates, methamphetamine or cannabis abuse;\n * Loss of blood in excess of 50 mL to 499 mL within 30 days or 500 ml within 56 days of the first dose of trial treatment (e.g., donation, plasmapheresis or injury);\n * Excessive sports or sauna within 5 days before start of the treatment phase and unwilling to abstain during the trial;\n * Have a platelet count <150,000/mm3 and in the judgment of the investigator, presents a significant bleeding risk;\n * History of gastrointestinal bleeding or perforation, related to previous NSAID therapy. Active, or history of recurrent peptic ulcer/hemorrhage (two or more distinct episodes of proven ulceration or bleeding);\n * Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic diseases (including glaucoma or benign prostatic hypertrophy) or malignancies or any other disease or condition which could influence the metabolism of the drug;",{"$nulls":4},"Actual","2018-01-10","Actual","Actual","2018-03-19","Actual","2018-04-01","2018-01-05","2018-01-05","2018-04-04","No",null,"Interventional","Treatment","Crossover Assignment","None (Open Label)","Randomized","18 Years","55 Years","All",null,"Yes",{"$nulls":4},"Yes","No",{"$nulls":19},"AUC|AUC(0-tlast)|Cmax","Area under the concentration vs. time curve from zero to infinity after single (first) dose|Area under plasma concentration vs. time curve from zero to last data point >LLOQ (lower limit of quantitation), calculated up by linear trapezoidal rule, down by logarithmic trapezoidal rule|Maximum observed drug concentration, directly observed from analytical data","Within 30 minutes prior to dosing (baseline) 10, 20, 30, 45, 60 minutes and 1 hour 20 minutes, 1 hour 40 minutes, 2, 2 hours 30 minutes, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48 and 72 hours post-dose","Number of adverse events as a measure of safety and tolerability","Up to 5 weeks",{"$nulls":4},"San Antonio, Texas, United States, 78219","Texas","United States","Icon Development Solutions, Llc",{"$nulls":3},"Bayer Study Director","2018-04-04","2020-05-25T16:36:15.249","2020-05-26T17:10:42.972","NCT03396250"]
["5ecbf3ff307e3d1b1f8d9caf","NCT03396250","2018-05-08","Bayer","BAYN","Completed","A Pharmacokinetic Trial of Naproxen Sodium and Diphenhydramine Hydrochloride Soft Capsules Versus Naproxen Sodium and Diphenhydramine Hydrochloride Tablets in Healthy Adult Subjects","Diphenhydramine|Naproxen","H1 Antagonist|COX Inhibitor","No",null,"No",null,"Phase 1",2,36,"Actual","2018-02-12","2018-03-26","AUC","Area Under The Curve",{"$nulls":3},"To evaluate the relative bioavailability of Naproxen Sodium 220 mg and diphenhydramine hydrochloride (DPH HCL) 25 mg soft capsules (Test) versus Naproxen Sodium 220 mg and diphenhydramine hydrochloride 25 mg tablets (Reference) after a single oral administration under fasted condition in healthy adults subjects.\n\nTo assess the safety and tolerability of the investigational products in terms of advent events (AEs) and clinical parameters.",null,"An Open Label Crossover Pharmacokinetic Trial of Naproxen Sodium and Diphenhydramine Hydrochloride Soft Capsules Versus Naproxen Sodium and Diphenhydramine Hydrochloride Tablets in Healthy Adult Subjects Under Fasted Conditions",17934,"Pain","Healthy Volunteers|Pain Unspecified","Healthy|Neurologic Manifestations","Healthy|Central Nervous System","Experimental","Test product + Reference product|Reference product + Test product","Each treatment sequence consists of two treatment periods with each period consisting of 4 days starting with an overnight fast of at least 10 hours followed by a single dose of study drug administration the morning of Day 1, then a 72-hour PK (Pharmacokinetic) blood sampling period. The two drug administrations are separated by a 7 calendar days washout phase.|Each treatment sequence consists of two treatment periods with each period consisting of 4 days starting with an overnight fast of at least 10 hours followed by a single dose of study drug administration the morning of Day 1, then a 72-hour PK blood sampling period. The two drug administrations are separated by a 7 calendar days washout phase.","Drug","Naproxen sodium and diphenhydramine hydrochloride soft capsules|Naproxen sodium and diphenhydramine hydrochloride coated tablets (Aleve, PMBAY98-7111)","Single oral administration of Naproxen sodium 220 mg/DPH HCl 25mg (2 capsules)|Single administration of Naproxen sodium 220 mg/DPH HCl 25mg (2 tablets)",null,"Test product + Reference product|Reference product + Test product","\n\n * Healthy adult men or women\n * Age 18 to 55 years inclusive;\n * Body mass index 18.5 to 30.0 kg/m2 inclusive\n\n","\n\n * History of hypersensitivity symptoms with the use of naproxen/naproxen sodium, diphenhydramine hydrochloride/citrate, acetylsalicylic acid, other Nonsteroidal anti-inflammatory drugs (NSAIDs) or similar pharmacological agents or components of the products;\n * Females who are pregnant or lactating;\n * Vegetarian or restricted diet (e.g., gluten-free);\n * Any active disease, acute or chronic;\n * Have taken naproxen/naproxen sodium, DPH HCl or diphenhydramine citrate, DPH HCl or diphenhydramine citrate-containing products, acetylsalicylic acid (ASA), ASA-containing products, acetaminophen, ibuprofen, any other NSAID (Over-the -counter [OTC] or prescription) or NSAID containing products, xanthines, antihistamines or caffeine-containing products (e.g. coffee, tea and chocolate) 7 days prior to dosing or during the Dosing Periods, other than trial treatment;\n * Use of any over-the-counter or prescription medications, vitamins or herbal supplements (except acceptable forms of birth control) within 7 days prior to dosing or throughout the trial, unless in the opinion of the Investigator, the medication will not interfere with the trial procedures, data integrity, or compromise the safety of the subject;\n * Positive test for Human immunodeficiency virus (HIV) antibodies and antigens;\n * Positive test for hepatitis B surface antigen (HBsAg) test;\n * Positive test for anti-hepatitis C virus (Anti-HCV) antibodies;\n * In the judgment of the investigator, any need of other medication during the trial besides the test and reference study medication;\n * Recently had (past 30 days) or plan to have surgery, an invasive procedure, tattoos or piercings during the trial or within 2 weeks after treatment;\n * More than moderate alcohol consumption (>40 g of alcohol regularly per day);\n * Positive alcohol or drug screen at Screening or on Day -1 of each dosing period.\n * Any history or suspicion of barbiturate, amphetamine, benzodiazepine, cocaine, opiates, methamphetamine or cannabis abuse;\n * Loss of blood in excess of 50 mL to 499 mL within 30 days or 500 ml within 56 days of the first dose of trial treatment (e.g., donation, plasmapheresis or injury);\n * Excessive sports or sauna within 5 days before start of the treatment phase and unwilling to abstain during the trial;\n * Have a platelet count <150,000/mm3 and in the judgment of the investigator, presents a significant bleeding risk;\n * History of gastrointestinal bleeding or perforation, related to previous NSAID therapy. Active, or history of recurrent peptic ulcer/hemorrhage (two or more distinct episodes of proven ulceration or bleeding);\n * Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic diseases (including glaucoma or benign prostatic hypertrophy) or malignancies or any other disease or condition which could influence the metabolism of the drug;",{"$nulls":4},"Actual","2018-01-10","Actual","Actual","2018-03-26","Actual","2018-05-01","2018-01-05","2018-01-05","2018-05-07","No",null,"Interventional","Treatment","Crossover Assignment","None (Open Label)","Randomized","18 Years","55 Years","All",null,"Yes",{"$nulls":4},"Yes","No",{"$nulls":19},"AUC|AUC(0-tlast)|Cmax","Area under the concentration vs. time curve from zero to infinity after single (first) dose|Area under plasma concentration vs. time curve from zero to last data point >LLOQ (lower limit of quantitation), calculated up by linear trapezoidal rule, down by logarithmic trapezoidal rule|Maximum observed drug concentration, directly observed from analytical data","Within 30 minutes prior to dosing (baseline) 10, 20, 30, 45, 60 minutes and 1 hour 20 minutes, 1 hour 40 minutes, 2, 2 hours 30 minutes, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48 and 72 hours post-dose","Number of adverse events as a measure of safety and tolerability","Up to 5 weeks",{"$nulls":4},"San Antonio, Texas, United States, 78219","Texas","United States","Icon Development Solutions, Llc",{"$nulls":3},"Bayer Study Director","2018-05-07","2020-05-25T16:36:15.002","2020-05-26T17:10:42.972","NCT03396250"]
["5ecbf3fffeab101b1553084f","NCT03396250","2019-03-20","Bayer","BAYN","Completed","A Pharmacokinetic Trial of Naproxen Sodium and Diphenhydramine Hydrochloride Soft Capsules Versus Naproxen Sodium and Diphenhydramine Hydrochloride Tablets in Healthy Adult Subjects","Diphenhydramine|Naproxen","H1 Antagonist|COX Inhibitor","No",null,"No",null,"Phase 1",2,36,"Actual","2018-02-12","2018-03-26","AUC","Area Under The Curve",{"$nulls":3},"To evaluate the relative bioavailability of Naproxen Sodium 220 mg and diphenhydramine hydrochloride (DPH HCL) 25 mg soft capsules (Test) versus Naproxen Sodium 220 mg and diphenhydramine hydrochloride 25 mg tablets (Reference) after a single oral administration under fasted condition in healthy adults subjects.\n\nTo assess the safety and tolerability of the investigational products in terms of advent events (AEs) and clinical parameters.",null,"An Open Label Crossover Pharmacokinetic Trial of Naproxen Sodium and Diphenhydramine Hydrochloride Soft Capsules Versus Naproxen Sodium and Diphenhydramine Hydrochloride Tablets in Healthy Adult Subjects Under Fasted Conditions",17934,"Pain","Healthy Volunteers|Pain Unspecified","Healthy|Neurologic Manifestations","Healthy|Central Nervous System","Experimental","Test product + Reference product|Reference product + Test product","Each treatment sequence consists of two treatment periods with each period consisting of 4 days starting with an overnight fast of at least 10 hours followed by a single dose of study drug administration the morning of Day 1, then a 72-hour PK (Pharmacokinetic) blood sampling period. The two drug administrations are separated by a 7 calendar days washout phase.|Each treatment sequence consists of two treatment periods with each period consisting of 4 days starting with an overnight fast of at least 10 hours followed by a single dose of study drug administration the morning of Day 1, then a 72-hour PK blood sampling period. The two drug administrations are separated by a 7 calendar days washout phase.","Drug","Naproxen sodium and diphenhydramine hydrochloride soft capsules|Naproxen sodium and diphenhydramine hydrochloride coated tablets (Aleve, PMBAY98-7111)","Single oral administration of Naproxen sodium 220 mg/DPH HCl 25mg (2 capsules)|Single administration of Naproxen sodium 220 mg/DPH HCl 25mg (2 tablets)",null,"Test product + Reference product|Reference product + Test product","\n\n * Healthy adult men or women\n * Age 18 to 55 years inclusive;\n * Body mass index 18.5 to 30.0 kg/m2 inclusive\n\n","\n\n * History of hypersensitivity symptoms with the use of naproxen/naproxen sodium, diphenhydramine hydrochloride/citrate, acetylsalicylic acid, other Nonsteroidal anti-inflammatory drugs (NSAIDs) or similar pharmacological agents or components of the products;\n * Females who are pregnant or lactating;\n * Vegetarian or restricted diet (e.g., gluten-free);\n * Any active disease, acute or chronic;\n * Have taken naproxen/naproxen sodium, DPH HCl or diphenhydramine citrate, DPH HCl or diphenhydramine citrate-containing products, acetylsalicylic acid (ASA), ASA-containing products, acetaminophen, ibuprofen, any other NSAID (Over-the -counter [OTC] or prescription) or NSAID containing products, xanthines, antihistamines or caffeine-containing products (e.g. coffee, tea and chocolate) 7 days prior to dosing or during the Dosing Periods, other than trial treatment;\n * Use of any over-the-counter or prescription medications, vitamins or herbal supplements (except acceptable forms of birth control) within 7 days prior to dosing or throughout the trial, unless in the opinion of the Investigator, the medication will not interfere with the trial procedures, data integrity, or compromise the safety of the subject;\n * Positive test for Human immunodeficiency virus (HIV) antibodies and antigens;\n * Positive test for hepatitis B surface antigen (HBsAg) test;\n * Positive test for anti-hepatitis C virus (Anti-HCV) antibodies;\n * In the judgment of the investigator, any need of other medication during the trial besides the test and reference study medication;\n * Recently had (past 30 days) or plan to have surgery, an invasive procedure, tattoos or piercings during the trial or within 2 weeks after treatment;\n * More than moderate alcohol consumption (>40 g of alcohol regularly per day);\n * Positive alcohol or drug screen at Screening or on Day -1 of each dosing period.\n * Any history or suspicion of barbiturate, amphetamine, benzodiazepine, cocaine, opiates, methamphetamine or cannabis abuse;\n * Loss of blood in excess of 50 mL to 499 mL within 30 days or 500 ml within 56 days of the first dose of trial treatment (e.g., donation, plasmapheresis or injury);\n * Excessive sports or sauna within 5 days before start of the treatment phase and unwilling to abstain during the trial;\n * Have a platelet count <150,000/mm3 and in the judgment of the investigator, presents a significant bleeding risk;\n * History of gastrointestinal bleeding or perforation, related to previous NSAID therapy. Active, or history of recurrent peptic ulcer/hemorrhage (two or more distinct episodes of proven ulceration or bleeding);\n * Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic diseases (including glaucoma or benign prostatic hypertrophy) or malignancies or any other disease or condition which could influence the metabolism of the drug;",{"$nulls":4},"Actual","2018-01-10","Actual","Actual","2018-03-29","Actual","2019-03-01","2018-01-05","2018-01-05","2019-03-19","No",null,"Interventional","Treatment","Crossover Assignment","None (Open Label)","Randomized","18 Years","55 Years","All",null,"Yes",null,null,"URL: https://clinicaltrials.bayer.com/ [https://clinicaltrials.bayer.com/] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: Click here to find results for studies related to Bayer products.",null,"Yes","No",{"$nulls":19},"AUC|AUC(0-tlast)|Cmax","Area under the concentration vs. time curve from zero to infinity after single (first) dose|Area under plasma concentration vs. time curve from zero to last data point >LLOQ (lower limit of quantitation), calculated up by linear trapezoidal rule, down by logarithmic trapezoidal rule|Maximum observed drug concentration, directly observed from analytical data","Within 30 minutes prior to dosing (baseline) 10, 20, 30, 45, 60 minutes and 1 hour 20 minutes, 1 hour 40 minutes, 2, 2 hours 30 minutes, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48 and 72 hours post-dose","Number of adverse events as a measure of safety and tolerability","Up to 5 weeks",{"$nulls":4},"San Antonio, Texas, United States, 78219","Texas","United States","Icon Development Solutions, Llc",{"$nulls":3},"Bayer Study Director","2019-03-19","2020-05-25T16:36:15.256","2020-05-26T17:10:42.972","NCT03396250"]
["5ecbf3ff11702c1b1b916a31","NCT03396445","2018-01-11","Merck","MRK","Not yet recruiting","Safety and Pharmacokinetics Study of MK-5890 as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Adults With Advanced Solid Tumors (MK-5890-001)","Pembrolizumab","PD-1 Inhibitor","Unknown",null,"Unknown",null,"Phase 1",2,88,"Anticipated","2018-02-22","2020-11-24","DLT","Dose Limiting Toxicity",{"$nulls":3},"The purpose of this study is to assess the safety and pharmacokinetics of MK-5890 when administered alone and in combination with pembrolizumab (MK-3475) in adults with advanced solid tumors. The initial course of MK-5890 monotherapy or MK-5890 plus pembrolizumab combination therapy will be for up to 35 administrations (approximately 2 years).","Participants receiving MK-5890 monotherapy who experience disease progression may be eligible to switch to receiving MK-5890 plus pembrolizumab combination therapy for up to 35 cycles (approximately 2 years) at the discretion of the Investigator and approval of the Sponsor.","A Phase 1 Study of MK-5890 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors","5890-001","Pharmacokinetics\nSolid Tumor","Oncology Solid Tumor Unspecified|Oncology Unspecified|Other","Oncology Solid Tumor|Oncology Unspecified|Other","Oncology|Other","Experimental","MK-5890|MK-5890 + Pembrolizumab","Participants receive escalating doses of MK-5890 via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years).|Participants receive escalating doses of MK-5890 via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years).","Drug|Biological","MK-5890|Pembrolizumab","IV infusion","MK-3475","MK-5890|MK-5890 + Pembrolizumab","\n\n * Histologically or cytologically confirmed advanced/metastatic solid tumor by pathology report and has received, been intolerant to, or refused all treatment known to confer clinical benefit.\n * Measureable disease by RECIST 1.1. as assessed by the local site investigator/radiologist. Target lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.\n * Adequate organ function.\n * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n * Male participants must agree to use adequate contraception during the treatment period and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period.\n * Female participants must not be pregnant or breast feeding and agree to follow use adequate contraception during the treatment period and for at least 120 days after the last dose of study treatment.\n * Submit an evaluable baseline tumor sample for analysis (either a newly obtained or archival tumor sample).\n\n","\n\n * History of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years.\n * Clinically active central nervous system metastases and/or carcinomatous meningitis.\n * Has had a severe hypersensitivity reaction to treatment with a monoclonal antibody (mAb) and/or other components of the study treatment.\n * Active infection requiring systemic treatment.\n * History of interstitial lung disease.\n * History of (noninfectious) pneumonitis that required steroids or current pneumonitis.\n * Symptomatic ascites or pleural effusion.\n * Previously had a stem cell or bone marrow transplant.\n * Previously had a solid organ transplant.\n * Active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs) except vitiligo or resolved childhood asthma/atopy.\n * Known human immunodeficiency virus (HIV) and/or active and acute Hepatitis B or C infections.\n * Not fully recovered from any effects of major surgery without significant detectable infection.\n * Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study.\n * Had chemotherapy, definitive radiation, or biological cancer therapy within 4 weeks (2 weeks for palliative radiation) before the first dose of study treatment, or has not recovered to Grade â‰¤1 or better from any AEs that were due to cancer therapeutics administered more than 4 weeks earlier.\n * Expected to require any other form of antineoplastic therapy while participating in this study.\n * On chronic systemic steroid therapy in excess of replacement doses (e.g., exceeding 10 mg/day of prednisone equivalent), or on any other form of immunosuppressive medication.\n * Regular user (including \"recreational use\") of any illicit drugs at the time of signing informed consent, or has a recent history (within the last year) of substance abuse (including alcohol), as determined by the treating investigator. Participants who use cannabis for medicinal purposes or to treat specific symptoms will not be excluded unless it is being abused in the opinion of the treating investigator.\n * Received a live-virus vaccine within 28 days before the first dose of study treatment.\n * Currently participating and receiving study treatment in a study of an investigational agent or has participated and received study treatment in a study of an investigational agent or has used an investigational device within 28 days before the first dose of study treatment.",{"$nulls":4},"Actual","2018-01-11","Actual","Anticipated","2020-11-24","Anticipated","2018-01-01","2018-01-04","2018-01-04","2018-01-04","No",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"MK-5890-001","Merck Protocol Number","Dose-limiting Toxicities (DLTs) Graded Using National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 or Later|Adverse Events (AEs)|Study Treatment Discontinuations Due to an AE","A DLT is defined as any of the following toxicities, if assessed by the investigator to be related to study treatment:\n\n * Grade 4 nonhematologic toxicity;\n * Grade 4 hematologic toxicity lasting â‰¥7 days, except thrombocytopenia;\n * Grade 4 thrombocytopenia;\n * Grade 3 thrombocytopenia associated with bleeding that requires a platelet transfusion;\n * Nonhematologic adverse event (AE) Grade â‰¥3 in severity, with exceptions;\n * Grade 3 or 4 nonhematologic laboratory abnormality if: clinically significant medical intervention is required or if abnormality leads to hospitalization, persists for >1 week or results in drug-induced liver injury with exceptions;\n * Grade 3 or Grade 4 febrile neutropenia;\n * Prolonged delay (>2 weeks) in initiating Cycle 2 due to treatment-related toxicity;\n * Treatment-related toxicity resulting in participant study treatment discontinuation during Cycle 1;\n * Missing >25% of the MK-5890 dose during Cycle 1 resulting from treatment-related AE;\n * Grade 5 toxicity.|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience at least one AE will be presented.|The number of participants who discontinue study treatment due to an AE will be presented.","Cycle 1 (Up to 21 days)|Up to 27 months|Up to 24 months","Area Under the Concentration-Time Curve (AUC) of MK-5890 When Administered as Monotherapy and in Combination with Pembrolizumab|Minimum Serum Concentration (Cmin) of MK-5890 When Administered as Monotherapy and in Combination with Pembrolizumab|Maximum Serum Concentration (Cmin) of MK-5890 When Administered as Monotherapy and in Combination with Pembrolizumab","Blood samples will be obtained at designated time points for the assessment of MK-5890 AUC: Cycles 1-4: Day 1: Predose, (end of pembrolizumab infusion for participants receiving pembrolizumab), end of MK-5890 infusion, 2 hours post start of MK-5890 infusion, Days 2, 3, 5, 8 & 15: Once daily; Cycles 5, 6 & every 4 cycles thereafter: Day1: Predose; 30 days post last dose. (Up to 25 months)|Blood samples will be obtained at designated time points for the assessment of MK-5890 Cmin: Cycles 1-4: Day 1: Predose, (end of pembrolizumab infusion for participants receiving pembrolizumab), end of MK-5890 infusion, 2 hours post start of MK-5890 infusion, Days 2, 3, 5, 8 & 15: Once daily; Cycles 5, 6 & every 4 cycles thereafter: Day1: Predose; 30 days post last dose. (Up to 25 months)|Blood samples will be obtained at designated time points for the assessment of MK-5890 Cmax: Cycles 1-4: Day 1: Predose, (end of pembrolizumab infusion for participants receiving pembrolizumab), end of MK-5890 infusion, 2 hours post start of MK-5890 infusion, Days 2, 3, 5, 8 & 15: Once daily; Cycles 5, 6 & every 4 cycles thereafter: Day1: Predose; 30 days post last dose. (Up to 25 months)","At designated time points (Up to 25 months)",{"$nulls":10},"Medical Director","2018-01-04","2020-05-25T16:36:15.961","2020-05-26T17:10:42.972","NCT03396445"]
["5ecbf3ff307e3d1b1f8d9cb1","NCT03396445","2018-02-22","Merck","MRK","Recruiting","Safety and Pharmacokinetics Study of MK-5890 as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Adults With Advanced Solid Tumors (MK-5890-001)","Pembrolizumab","PD-1 Inhibitor","Unknown",null,"Unknown",null,"Phase 1",2,88,"Anticipated","2018-02-18","2020-11-24","DLT","Dose Limiting Toxicity",{"$nulls":3},"The purpose of this study is to assess the safety and pharmacokinetics of MK-5890 when administered alone and in combination with pembrolizumab (MK-3475) in adults with advanced solid tumors. The initial course of MK-5890 monotherapy or MK-5890 plus pembrolizumab combination therapy will be for up to 35 administrations (approximately 2 years).","Participants receiving MK-5890 monotherapy who experience disease progression may be eligible to switch to receiving MK-5890 plus pembrolizumab combination therapy for up to 35 cycles (approximately 2 years) at the discretion of the Investigator and approval of the Sponsor.","A Phase 1 Study of MK-5890 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors","5890-001","Pharmacokinetics\nSolid Tumor","Oncology Solid Tumor Unspecified|Oncology Unspecified|Other","Oncology Solid Tumor|Oncology Unspecified|Other","Oncology|Other","Experimental","MK-5890|MK-5890 + Pembrolizumab","Participants receive escalating doses of MK-5890 via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years).|Participants receive escalating doses of MK-5890 via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years).","Drug|Biological","MK-5890|Pembrolizumab","IV infusion","MK-3475","MK-5890|MK-5890 + Pembrolizumab","\n\n * Histologically or cytologically confirmed advanced/metastatic solid tumor by pathology report and has received, been intolerant to, or refused all treatment known to confer clinical benefit.\n * Measureable disease by RECIST 1.1. as assessed by the local site investigator/radiologist. Target lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.\n * Adequate organ function.\n * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n * Male participants must agree to use adequate contraception during the treatment period and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period.\n * Female participants must not be pregnant or breast feeding and agree to follow use adequate contraception during the treatment period and for at least 120 days after the last dose of study treatment.\n * Submit an evaluable baseline tumor sample for analysis (either a newly obtained or archival tumor sample).\n\n","\n\n * History of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years.\n * Clinically active central nervous system metastases and/or carcinomatous meningitis.\n * Has had a severe hypersensitivity reaction to treatment with a monoclonal antibody (mAb) and/or other components of the study treatment.\n * Active infection requiring systemic treatment.\n * History of interstitial lung disease.\n * History of (noninfectious) pneumonitis that required steroids or current pneumonitis.\n * Symptomatic ascites or pleural effusion.\n * Previously had a stem cell or bone marrow transplant.\n * Previously had a solid organ transplant.\n * Active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs) except vitiligo or resolved childhood asthma/atopy.\n * Known human immunodeficiency virus (HIV) and/or active and acute Hepatitis B or C infections.\n * Not fully recovered from any effects of major surgery without significant detectable infection.\n * Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study.\n * Had chemotherapy, definitive radiation, or biological cancer therapy within 4 weeks (2 weeks for palliative radiation) before the first dose of study treatment, or has not recovered to Grade â‰¤1 or better from any AEs that were due to cancer therapeutics administered more than 4 weeks earlier.\n * Expected to require any other form of antineoplastic therapy while participating in this study.\n * On chronic systemic steroid therapy in excess of replacement doses (e.g., exceeding 10 mg/day of prednisone equivalent), or on any other form of immunosuppressive medication.\n * Regular user (including \"recreational use\") of any illicit drugs at the time of signing informed consent, or has a recent history (within the last year) of substance abuse (including alcohol), as determined by the treating investigator. Participants who use cannabis for medicinal purposes or to treat specific symptoms will not be excluded unless it is being abused in the opinion of the treating investigator.\n * Received a live-virus vaccine within 28 days before the first dose of study treatment.\n * Currently participating and receiving study treatment in a study of an investigational agent or has participated and received study treatment in a study of an investigational agent or has used an investigational device within 28 days before the first dose of study treatment.",{"$nulls":4},"Actual","2018-01-11","Actual","Anticipated","2020-11-24","Anticipated","2018-02-01","2018-01-04","2018-01-04","2018-02-20","No",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"MK-5890-001","Merck Protocol Number","Dose-limiting Toxicities (DLTs) Graded Using National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 or Later|Adverse Events (AEs)|Study Treatment Discontinuations Due to an AE","A DLT is defined as any of the following toxicities, if assessed by the investigator to be related to study treatment:\n\n * Grade 4 nonhematologic toxicity;\n * Grade 4 hematologic toxicity lasting â‰¥7 days, except thrombocytopenia;\n * Grade 4 thrombocytopenia;\n * Grade 3 thrombocytopenia associated with bleeding that requires a platelet transfusion;\n * Nonhematologic adverse event (AE) Grade â‰¥3 in severity, with exceptions;\n * Grade 3 or 4 nonhematologic laboratory abnormality if: clinically significant medical intervention is required or if abnormality leads to hospitalization, persists for >1 week or results in drug-induced liver injury with exceptions;\n * Grade 3 or Grade 4 febrile neutropenia;\n * Prolonged delay (>2 weeks) in initiating Cycle 2 due to treatment-related toxicity;\n * Treatment-related toxicity resulting in participant study treatment discontinuation during Cycle 1;\n * Missing >25% of the MK-5890 dose during Cycle 1 resulting from treatment-related AE;\n * Grade 5 toxicity.|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience at least one AE will be presented.|The number of participants who discontinue study treatment due to an AE will be presented.","Cycle 1 (Up to 21 days)|Up to 27 months|Up to 24 months","Area Under the Concentration-Time Curve (AUC) of MK-5890 When Administered as Monotherapy and in Combination with Pembrolizumab|Minimum Serum Concentration (Cmin) of MK-5890 When Administered as Monotherapy and in Combination with Pembrolizumab|Maximum Serum Concentration (Cmin) of MK-5890 When Administered as Monotherapy and in Combination with Pembrolizumab","Blood samples will be obtained at designated time points for the assessment of MK-5890 AUC: Cycles 1-4: Day 1: Predose, (end of pembrolizumab infusion for participants receiving pembrolizumab), end of MK-5890 infusion, 2 hours post start of MK-5890 infusion, Days 2, 3, 5, 8 & 15: Once daily; Cycles 5, 6 & every 4 cycles thereafter: Day1: Predose; 30 days post last dose. (Up to 25 months)|Blood samples will be obtained at designated time points for the assessment of MK-5890 Cmin: Cycles 1-4: Day 1: Predose, (end of pembrolizumab infusion for participants receiving pembrolizumab), end of MK-5890 infusion, 2 hours post start of MK-5890 infusion, Days 2, 3, 5, 8 & 15: Once daily; Cycles 5, 6 & every 4 cycles thereafter: Day1: Predose; 30 days post last dose. (Up to 25 months)|Blood samples will be obtained at designated time points for the assessment of MK-5890 Cmax: Cycles 1-4: Day 1: Predose, (end of pembrolizumab infusion for participants receiving pembrolizumab), end of MK-5890 infusion, 2 hours post start of MK-5890 infusion, Days 2, 3, 5, 8 & 15: Once daily; Cycles 5, 6 & every 4 cycles thereafter: Day1: Predose; 30 days post last dose. (Up to 25 months)","At designated time points (Up to 25 months)","Trialsites@merck.com","Toll Free Number","1-888-577-8839","Ramat Gan, Israel|Sarasota, Florida, United States, 34232","Florida","Israel|United States","The Chaim Sheba Medical Center - Oncology Institute ( Site 0001)|Florida Cancer Specialists ( Site 0002)",{"$nulls":3},"Medical Director","2018-02-20","2020-05-25T16:36:15.742","2020-05-26T17:10:42.972","NCT03396445"]
["5ecbf400feab101b15530851","NCT03396445","2018-03-02","Merck","MRK","Recruiting","Safety and Pharmacokinetics Study of MK-5890 as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Adults With Advanced Solid Tumors (MK-5890-001)","Pembrolizumab","PD-1 Inhibitor","Unknown",null,"Unknown",null,"Phase 1",2,88,"Anticipated","2018-02-18","2020-11-24","DLT","Dose Limiting Toxicity",{"$nulls":3},"The purpose of this study is to assess the safety and pharmacokinetics of MK-5890 when administered alone and in combination with pembrolizumab (MK-3475) in adults with advanced solid tumors. The initial course of MK-5890 monotherapy or MK-5890 plus pembrolizumab combination therapy will be for up to 35 administrations (approximately 2 years).","Participants receiving MK-5890 monotherapy who experience disease progression may be eligible to switch to receiving MK-5890 plus pembrolizumab combination therapy for up to 35 cycles (approximately 2 years) at the discretion of the Investigator and approval of the Sponsor.","A Phase 1 Study of MK-5890 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors","5890-001","Pharmacokinetics\nSolid Tumor","Oncology Solid Tumor Unspecified|Oncology Unspecified|Other","Oncology Solid Tumor|Oncology Unspecified|Other","Oncology|Other","Experimental","MK-5890|MK-5890 + Pembrolizumab","Participants receive escalating doses of MK-5890 via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years).|Participants receive escalating doses of MK-5890 via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years).","Drug|Biological","MK-5890|Pembrolizumab","IV infusion","MK-3475","MK-5890|MK-5890 + Pembrolizumab","\n\n * Histologically or cytologically confirmed advanced/metastatic solid tumor by pathology report and has received, been intolerant to, or refused all treatment known to confer clinical benefit.\n * Measureable disease by RECIST 1.1. as assessed by the local site investigator/radiologist. Target lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.\n * Adequate organ function.\n * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n * Male participants must agree to use adequate contraception during the treatment period and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period.\n * Female participants must not be pregnant or breast feeding and agree to follow use adequate contraception during the treatment period and for at least 120 days after the last dose of study treatment.\n * Submit an evaluable baseline tumor sample for analysis (either a newly obtained or archival tumor sample).\n\n","\n\n * History of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years.\n * Clinically active central nervous system metastases and/or carcinomatous meningitis.\n * Has had a severe hypersensitivity reaction to treatment with a monoclonal antibody (mAb) and/or other components of the study treatment.\n * Active infection requiring systemic treatment.\n * History of interstitial lung disease.\n * History of (noninfectious) pneumonitis that required steroids or current pneumonitis.\n * Symptomatic ascites or pleural effusion.\n * Previously had a stem cell or bone marrow transplant.\n * Previously had a solid organ transplant.\n * Active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs) except vitiligo or resolved childhood asthma/atopy.\n * Known human immunodeficiency virus (HIV) and/or active and acute Hepatitis B or C infections.\n * Not fully recovered from any effects of major surgery without significant detectable infection.\n * Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study.\n * Had chemotherapy, definitive radiation, or biological cancer therapy within 4 weeks (2 weeks for palliative radiation) before the first dose of study treatment, or has not recovered to Grade â‰¤1 or better from any AEs that were due to cancer therapeutics administered more than 4 weeks earlier.\n * Expected to require any other form of antineoplastic therapy while participating in this study.\n * On chronic systemic steroid therapy in excess of replacement doses (e.g., exceeding 10 mg/day of prednisone equivalent), or on any other form of immunosuppressive medication.\n * Regular user (including \"recreational use\") of any illicit drugs at the time of signing informed consent, or has a recent history (within the last year) of substance abuse (including alcohol), as determined by the treating investigator. Participants who use cannabis for medicinal purposes or to treat specific symptoms will not be excluded unless it is being abused in the opinion of the treating investigator.\n * Received a live-virus vaccine within 28 days before the first dose of study treatment.\n * Currently participating and receiving study treatment in a study of an investigational agent or has participated and received study treatment in a study of an investigational agent or has used an investigational device within 28 days before the first dose of study treatment.",{"$nulls":4},"Actual","2018-01-11","Actual","Anticipated","2020-11-24","Anticipated","2018-03-01","2018-01-04","2018-01-04","2018-03-01","No",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"MK-5890-001","Merck Protocol Number","Dose-limiting Toxicities (DLTs) Graded Using National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 or Later|Adverse Events (AEs)|Study Treatment Discontinuations Due to an AE","A DLT is defined as any of the following toxicities, if assessed by the investigator to be related to study treatment:\n\n * Grade 4 nonhematologic toxicity;\n * Grade 4 hematologic toxicity lasting â‰¥7 days, except thrombocytopenia;\n * Grade 4 thrombocytopenia;\n * Grade 3 thrombocytopenia associated with bleeding that requires a platelet transfusion;\n * Nonhematologic adverse event (AE) Grade â‰¥3 in severity, with exceptions;\n * Grade 3 or 4 nonhematologic laboratory abnormality if: clinically significant medical intervention is required or if abnormality leads to hospitalization, persists for >1 week or results in drug-induced liver injury with exceptions;\n * Grade 3 or Grade 4 febrile neutropenia;\n * Prolonged delay (>2 weeks) in initiating Cycle 2 due to treatment-related toxicity;\n * Treatment-related toxicity resulting in participant study treatment discontinuation during Cycle 1;\n * Missing >25% of the MK-5890 dose during Cycle 1 resulting from treatment-related AE;\n * Grade 5 toxicity.|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience at least one AE will be presented.|The number of participants who discontinue study treatment due to an AE will be presented.","Cycle 1 (Up to 21 days)|Up to 27 months|Up to 24 months","Area Under the Concentration-Time Curve (AUC) of MK-5890 When Administered as Monotherapy and in Combination with Pembrolizumab|Minimum Serum Concentration (Cmin) of MK-5890 When Administered as Monotherapy and in Combination with Pembrolizumab|Maximum Serum Concentration (Cmin) of MK-5890 When Administered as Monotherapy and in Combination with Pembrolizumab","Blood samples will be obtained at designated time points for the assessment of MK-5890 AUC: Cycles 1-4: Day 1: Predose, (end of pembrolizumab infusion for participants receiving pembrolizumab), end of MK-5890 infusion, 2 hours post start of MK-5890 infusion, Days 2, 3, 5, 8 & 15: Once daily; Cycles 5, 6 & every 4 cycles thereafter: Day1: Predose; 30 days post last dose. (Up to 25 months)|Blood samples will be obtained at designated time points for the assessment of MK-5890 Cmin: Cycles 1-4: Day 1: Predose, (end of pembrolizumab infusion for participants receiving pembrolizumab), end of MK-5890 infusion, 2 hours post start of MK-5890 infusion, Days 2, 3, 5, 8 & 15: Once daily; Cycles 5, 6 & every 4 cycles thereafter: Day1: Predose; 30 days post last dose. (Up to 25 months)|Blood samples will be obtained at designated time points for the assessment of MK-5890 Cmax: Cycles 1-4: Day 1: Predose, (end of pembrolizumab infusion for participants receiving pembrolizumab), end of MK-5890 infusion, 2 hours post start of MK-5890 infusion, Days 2, 3, 5, 8 & 15: Once daily; Cycles 5, 6 & every 4 cycles thereafter: Day1: Predose; 30 days post last dose. (Up to 25 months)","At designated time points (Up to 25 months)","Trialsites@merck.com","Toll Free Number","1-888-577-8839","Tel Hashomer, Israel|Sarasota, Florida, United States, 34232","Florida","Israel|United States","Sheba Medical Center - Pharmacy ( Site 0001)|Florida Cancer Specialists ( Site 0002)",{"$nulls":3},"Medical Director","2018-03-01","2020-05-25T16:36:16.013","2020-05-26T17:10:42.972","NCT03396445"]
["5ecbf3ffe2561b1b11905d1c","NCT03396445","2018-03-16","Merck","MRK","Recruiting","Safety and Pharmacokinetics Study of MK-5890 as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Adults With Advanced Solid Tumors (MK-5890-001)","Pembrolizumab","PD-1 Inhibitor","Unknown",null,"Unknown",null,"Phase 1",2,88,"Anticipated","2018-02-18","2020-11-24","DLT","Dose Limiting Toxicity",{"$nulls":3},"The purpose of this study is to assess the safety and pharmacokinetics of MK-5890 when administered alone and in combination with pembrolizumab (MK-3475) in adults with advanced solid tumors. The initial course of MK-5890 monotherapy or MK-5890 plus pembrolizumab combination therapy will be for up to 35 administrations (approximately 2 years).","Participants receiving MK-5890 monotherapy who experience disease progression may be eligible to switch to receiving MK-5890 plus pembrolizumab combination therapy for up to 35 cycles (approximately 2 years) at the discretion of the Investigator and approval of the Sponsor.","A Phase 1 Study of MK-5890 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors","5890-001","Pharmacokinetics\nSolid Tumor","Oncology Solid Tumor Unspecified|Oncology Unspecified|Other","Oncology Solid Tumor|Oncology Unspecified|Other","Oncology|Other","Experimental","MK-5890|MK-5890 + Pembrolizumab","Participants receive escalating doses of MK-5890 via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years).|Participants receive escalating doses of MK-5890 via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years).","Drug|Biological","MK-5890|Pembrolizumab","IV infusion","MK-3475","MK-5890|MK-5890 + Pembrolizumab","\n\n * Histologically or cytologically confirmed advanced/metastatic solid tumor by pathology report and has received or been intolerant to all treatment known to confer clinical benefit.\n * Measureable disease by RECIST 1.1. as assessed by the local site investigator/radiologist. Target lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.\n * Adequate organ function.\n * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n * Male participants must agree to use adequate contraception during the treatment period and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period.\n * Female participants must not be pregnant or breast feeding and agree to follow use adequate contraception during the treatment period and for at least 120 days after the last dose of study treatment.\n * Submit an evaluable baseline tumor sample for analysis (either a newly obtained or archival tumor sample).\n\n","\n\n * History of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years.\n * Clinically active central nervous system metastases and/or carcinomatous meningitis.\n * Has had a severe hypersensitivity reaction to treatment with a monoclonal antibody (mAb) and/or other components of the study treatment.\n * Active infection requiring systemic treatment.\n * History of interstitial lung disease.\n * History of (noninfectious) pneumonitis that required steroids or current pneumonitis.\n * Symptomatic ascites or pleural effusion.\n * Previously had a stem cell or bone marrow transplant.\n * Previously had a solid organ transplant.\n * Active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs) except vitiligo or resolved childhood asthma/atopy.\n * Known human immunodeficiency virus (HIV) and/or active and acute Hepatitis B or C infections.\n * Not fully recovered from any effects of major surgery without significant detectable infection.\n * Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study.\n * Had chemotherapy, definitive radiation, or biological cancer therapy within 4 weeks (2 weeks for palliative radiation) before the first dose of study treatment, or has not recovered to Grade â‰¤1 or better from any AEs that were due to cancer therapeutics administered more than 4 weeks earlier.\n * Expected to require any other form of antineoplastic therapy while participating in this study.\n * On chronic systemic steroid therapy in excess of replacement doses (e.g., exceeding 10 mg/day of prednisone equivalent), or on any other form of immunosuppressive medication.\n * Regular user (including \"recreational use\") of any illicit drugs at the time of signing informed consent, or has a recent history (within the last year) of substance abuse (including alcohol), as determined by the treating investigator. Participants who use cannabis for medicinal purposes or to treat specific symptoms will not be excluded unless it is being abused in the opinion of the treating investigator.\n * Received a live-virus vaccine within 28 days before the first dose of study treatment.\n * Currently participating and receiving study treatment in a study of an investigational agent or has participated and received study treatment in a study of an investigational agent or has used an investigational device within 28 days before the first dose of study treatment.",{"$nulls":4},"Actual","2018-01-11","Actual","Anticipated","2020-11-24","Anticipated","2018-03-01","2018-01-04","2018-01-04","2018-03-15","No",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"MK-5890-001","Merck Protocol Number","Dose-limiting Toxicities (DLTs) Graded Using National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 or Later|Adverse Events (AEs)|Study Treatment Discontinuations Due to an AE","A DLT is defined as any of the following toxicities, if assessed by the investigator to be related to study treatment:\n\n * Grade 4 nonhematologic toxicity;\n * Grade 4 hematologic toxicity lasting â‰¥7 days, except thrombocytopenia;\n * Grade 4 thrombocytopenia;\n * Grade 3 thrombocytopenia associated with bleeding that requires a platelet transfusion;\n * Nonhematologic adverse event (AE) Grade â‰¥3 in severity, with exceptions;\n * Grade 3 or 4 nonhematologic laboratory abnormality if: clinically significant medical intervention is required or if abnormality leads to hospitalization, persists for >1 week or results in drug-induced liver injury with exceptions;\n * Grade 3 or Grade 4 febrile neutropenia;\n * Prolonged delay (>2 weeks) in initiating Cycle 2 due to treatment-related toxicity;\n * Treatment-related toxicity resulting in participant study treatment discontinuation during Cycle 1;\n * Missing >25% of the MK-5890 dose during Cycle 1 resulting from treatment-related AE;\n * Grade 5 toxicity.|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience at least one AE will be presented.|The number of participants who discontinue study treatment due to an AE will be presented.","Cycle 1 (Up to 21 days)|Up to 27 months|Up to 24 months","Area Under the Concentration-Time Curve (AUC) of MK-5890 When Administered as Monotherapy and in Combination with Pembrolizumab|Minimum Serum Concentration (Cmin) of MK-5890 When Administered as Monotherapy and in Combination with Pembrolizumab|Maximum Serum Concentration (Cmin) of MK-5890 When Administered as Monotherapy and in Combination with Pembrolizumab","Blood samples will be obtained at designated time points for the assessment of MK-5890 AUC: Cycles 1-4: Day 1: Predose, (end of pembrolizumab infusion for participants receiving pembrolizumab), end of MK-5890 infusion, 2 hours post start of MK-5890 infusion, Days 2, 3, 5, 8 & 15: Once daily; Cycles 5, 6 & every 4 cycles thereafter: Day1: Predose; 30 days post last dose. (Up to 25 months)|Blood samples will be obtained at designated time points for the assessment of MK-5890 Cmin: Cycles 1-4: Day 1: Predose, (end of pembrolizumab infusion for participants receiving pembrolizumab), end of MK-5890 infusion, 2 hours post start of MK-5890 infusion, Days 2, 3, 5, 8 & 15: Once daily; Cycles 5, 6 & every 4 cycles thereafter: Day1: Predose; 30 days post last dose. (Up to 25 months)|Blood samples will be obtained at designated time points for the assessment of MK-5890 Cmax: Cycles 1-4: Day 1: Predose, (end of pembrolizumab infusion for participants receiving pembrolizumab), end of MK-5890 infusion, 2 hours post start of MK-5890 infusion, Days 2, 3, 5, 8 & 15: Once daily; Cycles 5, 6 & every 4 cycles thereafter: Day1: Predose; 30 days post last dose. (Up to 25 months)","At designated time points (Up to 25 months)","Trialsites@merck.com","Toll Free Number","1-888-577-8839","Tel Hashomer, Israel|Sarasota, Florida, United States, 34232","Florida","Israel|United States","Sheba Medical Center - Pharmacy ( Site 0001)|Florida Cancer Specialists ( Site 0002)",{"$nulls":3},"Medical Director","2018-03-15","2020-05-25T16:36:15.980","2020-05-26T17:10:42.972","NCT03396445"]
["5ecbf40011702c1b1b916a32","NCT03396445","2018-05-24","Merck","MRK","Recruiting","Safety and Pharmacokinetics Study of MK-5890 as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Adults With Advanced Solid Tumors (MK-5890-001)","Pembrolizumab","PD-1 Inhibitor","Unknown",null,"Unknown",null,"Phase 1",2,88,"Anticipated","2018-02-18","2020-11-24","DLT","Dose Limiting Toxicity",{"$nulls":3},"The purpose of this study is to assess the safety and pharmacokinetics of MK-5890 when administered alone and in combination with pembrolizumab (MK-3475) in adults with advanced solid tumors. The initial course of MK-5890 monotherapy or MK-5890 plus pembrolizumab combination therapy will be for up to 35 administrations (approximately 2 years).","Participants receiving MK-5890 monotherapy who experience disease progression may be eligible to switch to receiving MK-5890 plus pembrolizumab combination therapy for up to 35 cycles (approximately 2 years) at the discretion of the Investigator and approval of the Sponsor.","A Phase 1 Study of MK-5890 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors","5890-001","Pharmacokinetics\nSolid Tumor","Oncology Solid Tumor Unspecified|Oncology Unspecified|Other","Oncology Solid Tumor|Oncology Unspecified|Other","Oncology|Other","Experimental","MK-5890|MK-5890 + Pembrolizumab","Participants receive escalating doses of MK-5890 via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years).|Participants receive escalating doses of MK-5890 via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years).","Drug|Biological","MK-5890|Pembrolizumab","IV infusion","MK-3475","MK-5890|MK-5890 + Pembrolizumab","\n\n * Histologically or cytologically confirmed advanced/metastatic solid tumor by pathology report and has received or been intolerant to all treatment known to confer clinical benefit.\n * Measureable disease by RECIST 1.1. as assessed by the local site investigator/radiologist. Target lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.\n * Adequate organ function.\n * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n * Male participants must agree to use adequate contraception during the treatment period and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period.\n * Female participants must not be pregnant or breast feeding and agree to follow use adequate contraception during the treatment period and for at least 120 days after the last dose of study treatment.\n * Submit an evaluable baseline tumor sample for analysis (either a newly obtained or archival tumor sample).\n\n","\n\n * History of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years.\n * Clinically active central nervous system metastases and/or carcinomatous meningitis.\n * Has had a severe hypersensitivity reaction to treatment with a monoclonal antibody (mAb) and/or other components of the study treatment.\n * Active infection requiring systemic treatment.\n * History of interstitial lung disease.\n * History of (noninfectious) pneumonitis that required steroids or current pneumonitis.\n * Symptomatic ascites or pleural effusion.\n * Previously had a stem cell or bone marrow transplant.\n * Previously had a solid organ transplant.\n * Active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs) except vitiligo or resolved childhood asthma/atopy.\n * Known human immunodeficiency virus (HIV) and/or active and acute Hepatitis B or C infections.\n * Not fully recovered from any effects of major surgery without significant detectable infection.\n * Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study.\n * Had chemotherapy, definitive radiation, or biological cancer therapy within 4 weeks (2 weeks for palliative radiation) before the first dose of study treatment, or has not recovered to Grade â‰¤1 or better from any AEs that were due to cancer therapeutics administered more than 4 weeks earlier.\n * Expected to require any other form of antineoplastic therapy while participating in this study.\n * On chronic systemic steroid therapy in excess of replacement doses (e.g., exceeding 10 mg/day of prednisone equivalent), or on any other form of immunosuppressive medication.\n * Regular user (including \"recreational use\") of any illicit drugs at the time of signing informed consent, or has a recent history (within the last year) of substance abuse (including alcohol), as determined by the treating investigator. Participants who use cannabis for medicinal purposes or to treat specific symptoms will not be excluded unless it is being abused in the opinion of the treating investigator.\n * Received a live-virus vaccine within 28 days before the first dose of study treatment.\n * Currently participating and receiving study treatment in a study of an investigational agent or has participated and received study treatment in a study of an investigational agent or has used an investigational device within 28 days before the first dose of study treatment.",{"$nulls":4},"Actual","2018-01-11","Actual","Anticipated","2020-11-24","Anticipated","2018-05-01","2018-01-04","2018-01-04","2018-05-23","No",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"MK-5890-001","Merck Protocol Number","Dose-limiting Toxicities (DLTs) Graded Using National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 or Later|Adverse Events (AEs)|Study Treatment Discontinuations Due to an AE","A DLT is defined as any of the following toxicities, if assessed by the investigator to be related to study treatment:\n\n * Grade 4 nonhematologic toxicity;\n * Grade 4 hematologic toxicity lasting â‰¥7 days, except thrombocytopenia;\n * Grade 4 thrombocytopenia;\n * Grade 3 thrombocytopenia associated with bleeding that requires a platelet transfusion;\n * Nonhematologic adverse event (AE) Grade â‰¥3 in severity, with exceptions;\n * Grade 3 or 4 nonhematologic laboratory abnormality if: clinically significant medical intervention is required or if abnormality leads to hospitalization, persists for >1 week or results in drug-induced liver injury with exceptions;\n * Grade 3 or Grade 4 febrile neutropenia;\n * Prolonged delay (>2 weeks) in initiating Cycle 2 due to treatment-related toxicity;\n * Treatment-related toxicity resulting in participant study treatment discontinuation during Cycle 1;\n * Missing >25% of the MK-5890 dose during Cycle 1 resulting from treatment-related AE;\n * Grade 5 toxicity.|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience at least one AE will be presented.|The number of participants who discontinue study treatment due to an AE will be presented.","Cycle 1 (Up to 21 days)|Up to 27 months|Up to 24 months","Area Under the Concentration-Time Curve (AUC) of MK-5890 When Administered as Monotherapy and in Combination with Pembrolizumab|Minimum Serum Concentration (Cmin) of MK-5890 When Administered as Monotherapy and in Combination with Pembrolizumab|Maximum Serum Concentration (Cmin) of MK-5890 When Administered as Monotherapy and in Combination with Pembrolizumab","Blood samples will be obtained at designated time points for the assessment of MK-5890 AUC: Cycles 1-4: Day 1: Predose, (end of pembrolizumab infusion for participants receiving pembrolizumab), end of MK-5890 infusion, 2 hours post start of MK-5890 infusion, Days 2, 3, 5, 8 & 15: Once daily; Cycles 5, 6 & every 4 cycles thereafter: Day1: Predose; 30 days post last dose. (Up to 25 months)|Blood samples will be obtained at designated time points for the assessment of MK-5890 Cmin: Cycles 1-4: Day 1: Predose, (end of pembrolizumab infusion for participants receiving pembrolizumab), end of MK-5890 infusion, 2 hours post start of MK-5890 infusion, Days 2, 3, 5, 8 & 15: Once daily; Cycles 5, 6 & every 4 cycles thereafter: Day1: Predose; 30 days post last dose. (Up to 25 months)|Blood samples will be obtained at designated time points for the assessment of MK-5890 Cmax: Cycles 1-4: Day 1: Predose, (end of pembrolizumab infusion for participants receiving pembrolizumab), end of MK-5890 infusion, 2 hours post start of MK-5890 infusion, Days 2, 3, 5, 8 & 15: Once daily; Cycles 5, 6 & every 4 cycles thereafter: Day1: Predose; 30 days post last dose. (Up to 25 months)","At designated time points (Up to 25 months)","Trialsites@merck.com","Toll Free Number","1-888-577-8839","Tel Hashomer, Israel|Amsterdam, Netherlands|Sarasota, Florida, United States, 34232","Florida","Israel|Netherlands|United States","Sheba Medical Center - Pharmacy ( Site 0001)|Antoni Van Leeuwenhoek Ziekenhuis ( Site 0003)|Florida Cancer Specialists ( Site 0002)",{"$nulls":3},"Medical Director","2018-05-23","2020-05-25T16:36:16.260","2020-05-26T17:10:42.972","NCT03396445"]
["5ecbf400e2561b1b11905d1d","NCT03396445","2018-06-15","Merck","MRK","Recruiting","Safety and Pharmacokinetics Study of MK-5890 as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Adults With Advanced Solid Tumors (MK-5890-001)","Pembrolizumab","PD-1 Inhibitor","Unknown",null,"Unknown",null,"Phase 1",2,88,"Anticipated","2018-02-18","2020-11-24","DLT","Dose Limiting Toxicity",{"$nulls":3},"The purpose of this study is to assess the safety and pharmacokinetics of MK-5890 when administered alone and in combination with pembrolizumab (MK-3475) in adults with advanced solid tumors. The initial course of MK-5890 monotherapy or MK-5890 plus pembrolizumab combination therapy will be for up to 35 administrations (approximately 2 years).","Participants receiving MK-5890 monotherapy who experience disease progression may be eligible to switch to receiving MK-5890 plus pembrolizumab combination therapy for up to 35 cycles (approximately 2 years) at the discretion of the Investigator and approval of the Sponsor.","A Phase 1 Study of MK-5890 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors","5890-001","Pharmacokinetics\nSolid Tumor","Oncology Solid Tumor Unspecified|Oncology Unspecified|Other","Oncology Solid Tumor|Oncology Unspecified|Other","Oncology|Other","Experimental","MK-5890|MK-5890 + Pembrolizumab","Participants receive escalating doses of MK-5890 via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years).|Participants receive escalating doses of MK-5890 via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years).","Drug|Biological","MK-5890|Pembrolizumab","IV infusion","MK-3475","MK-5890|MK-5890 + Pembrolizumab","\n\n * Histologically or cytologically confirmed advanced/metastatic solid tumor by pathology report and has received or been intolerant to all treatment known to confer clinical benefit.\n * Measureable disease by RECIST 1.1. as assessed by the local site investigator/radiologist. Target lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.\n * Adequate organ function.\n * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n * Male participants must agree to use adequate contraception during the treatment period and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period.\n * Female participants must not be pregnant or breast feeding and agree to follow use adequate contraception during the treatment period and for at least 120 days after the last dose of study treatment.\n * Submit an evaluable baseline tumor sample for analysis (either a newly obtained or archival tumor sample).\n\n","\n\n * History of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years.\n * Clinically active central nervous system metastases and/or carcinomatous meningitis.\n * Has had a severe hypersensitivity reaction to treatment with a monoclonal antibody (mAb) and/or other components of the study treatment.\n * Active infection requiring systemic treatment.\n * History of interstitial lung disease.\n * History of (noninfectious) pneumonitis that required steroids or current pneumonitis.\n * Symptomatic ascites or pleural effusion.\n * Previously had a stem cell or bone marrow transplant.\n * Previously had a solid organ transplant.\n * Active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs) except vitiligo or resolved childhood asthma/atopy.\n * Known human immunodeficiency virus (HIV) and/or active and acute Hepatitis B or C infections.\n * Not fully recovered from any effects of major surgery without significant detectable infection.\n * Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study.\n * Had chemotherapy, definitive radiation, or biological cancer therapy within 4 weeks (2 weeks for palliative radiation) before the first dose of study treatment, or has not recovered to Grade â‰¤1 or better from any AEs that were due to cancer therapeutics administered more than 4 weeks earlier.\n * Expected to require any other form of antineoplastic therapy while participating in this study.\n * On chronic systemic steroid therapy in excess of replacement doses (e.g., exceeding 10 mg/day of prednisone equivalent), or on any other form of immunosuppressive medication.\n * Regular user (including \"recreational use\") of any illicit drugs at the time of signing informed consent, or has a recent history (within the last year) of substance abuse (including alcohol), as determined by the treating investigator. Participants who use cannabis for medicinal purposes or to treat specific symptoms will not be excluded unless it is being abused in the opinion of the treating investigator.\n * Received a live-virus vaccine within 28 days before the first dose of study treatment.\n * Currently participating and receiving study treatment in a study of an investigational agent or has participated and received study treatment in a study of an investigational agent or has used an investigational device within 28 days before the first dose of study treatment.",{"$nulls":4},"Actual","2018-01-11","Actual","Anticipated","2020-11-24","Anticipated","2018-06-01","2018-01-04","2018-01-04","2018-06-14","No",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"MK-5890-001","Merck Protocol Number","Dose-limiting Toxicities (DLTs) Graded Using National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 or Later|Adverse Events (AEs)|Study Treatment Discontinuations Due to an AE","A DLT is defined as any of the following toxicities, if assessed by the investigator to be related to study treatment:\n\n * Grade 4 nonhematologic toxicity;\n * Grade 4 hematologic toxicity lasting â‰¥7 days, except thrombocytopenia;\n * Grade 4 thrombocytopenia;\n * Grade 3 thrombocytopenia associated with bleeding that requires a platelet transfusion;\n * Nonhematologic adverse event (AE) Grade â‰¥3 in severity, with exceptions;\n * Grade 3 or 4 nonhematologic laboratory abnormality if: clinically significant medical intervention is required or if abnormality leads to hospitalization, persists for >1 week or results in drug-induced liver injury with exceptions;\n * Grade 3 or Grade 4 febrile neutropenia;\n * Prolonged delay (>2 weeks) in initiating Cycle 2 due to treatment-related toxicity;\n * Treatment-related toxicity resulting in participant study treatment discontinuation during Cycle 1;\n * Missing >25% of the MK-5890 dose during Cycle 1 resulting from treatment-related AE;\n * Grade 5 toxicity.|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience at least one AE will be presented.|The number of participants who discontinue study treatment due to an AE will be presented.","Cycle 1 (Up to 21 days)|Up to 27 months|Up to 24 months","Area Under the Concentration-Time Curve (AUC) of MK-5890 When Administered as Monotherapy and in Combination with Pembrolizumab|Minimum Serum Concentration (Cmin) of MK-5890 When Administered as Monotherapy and in Combination with Pembrolizumab|Maximum Serum Concentration (Cmin) of MK-5890 When Administered as Monotherapy and in Combination with Pembrolizumab","Blood samples will be obtained at designated time points for the assessment of MK-5890 AUC: Cycles 1-4: Day 1: Predose, (end of pembrolizumab infusion for participants receiving pembrolizumab), end of MK-5890 infusion, 2 hours post start of MK-5890 infusion, Days 2, 3, 5, 8 & 15: Once daily; Cycles 5, 6 & every 4 cycles thereafter: Day1: Predose; 30 days post last dose. (Up to 25 months)|Blood samples will be obtained at designated time points for the assessment of MK-5890 Cmin: Cycles 1-4: Day 1: Predose, (end of pembrolizumab infusion for participants receiving pembrolizumab), end of MK-5890 infusion, 2 hours post start of MK-5890 infusion, Days 2, 3, 5, 8 & 15: Once daily; Cycles 5, 6 & every 4 cycles thereafter: Day1: Predose; 30 days post last dose. (Up to 25 months)|Blood samples will be obtained at designated time points for the assessment of MK-5890 Cmax: Cycles 1-4: Day 1: Predose, (end of pembrolizumab infusion for participants receiving pembrolizumab), end of MK-5890 infusion, 2 hours post start of MK-5890 infusion, Days 2, 3, 5, 8 & 15: Once daily; Cycles 5, 6 & every 4 cycles thereafter: Day1: Predose; 30 days post last dose. (Up to 25 months)","At designated time points (Up to 25 months)","Trialsites@merck.com","Toll Free Number","1-888-577-8839","Ramat Gan, Israel|Amsterdam, Netherlands|Sarasota, Florida, United States, 34232","Florida","Israel|Netherlands|United States","The Chaim Sheba Medical Center - Oncology Institute ( Site 0001)|Antoni Van Leeuwenhoek Ziekenhuis ( Site 0003)|Florida Cancer Specialists ( Site 0002)",{"$nulls":3},"Medical Director","2018-06-14","2020-05-25T16:36:16.400","2020-05-26T17:10:42.972","NCT03396445"]
["5ecbf400307e3d1b1f8d9cb2","NCT03396445","2018-06-25","Merck","MRK","Recruiting","Safety and Pharmacokinetics Study of MK-5890 as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Adults With Advanced Solid Tumors (MK-5890-001)","Pembrolizumab","PD-1 Inhibitor","Unknown",null,"Unknown",null,"Phase 1",2,88,"Anticipated","2018-02-18","2020-11-24","DLT","Dose Limiting Toxicity",{"$nulls":3},"The purpose of this study is to assess the safety and pharmacokinetics of MK-5890 when administered alone and in combination with pembrolizumab (MK-3475) in adults with advanced solid tumors. The initial course of MK-5890 monotherapy or MK-5890 plus pembrolizumab combination therapy will be for up to 35 administrations (approximately 2 years).","Participants receiving MK-5890 monotherapy who experience disease progression may be eligible to switch to receiving MK-5890 plus pembrolizumab combination therapy for up to 35 cycles (approximately 2 years) at the discretion of the Investigator and approval of the Sponsor.","A Phase 1 Study of MK-5890 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors","5890-001","Pharmacokinetics\nSolid Tumor","Oncology Solid Tumor Unspecified|Oncology Unspecified|Other","Oncology Solid Tumor|Oncology Unspecified|Other","Oncology|Other","Experimental","MK-5890|MK-5890 + Pembrolizumab","Participants receive escalating doses of MK-5890 via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years).|Participants receive escalating doses of MK-5890 via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years).","Drug|Biological","MK-5890|Pembrolizumab","IV infusion","MK-3475","MK-5890|MK-5890 + Pembrolizumab","\n\n * Histologically or cytologically confirmed advanced/metastatic solid tumor by pathology report and has received or been intolerant to all treatment known to confer clinical benefit.\n * Measureable disease by RECIST 1.1. as assessed by the local site investigator/radiologist. Target lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.\n * Adequate organ function.\n * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n * Male participants must agree to use adequate contraception during the treatment period and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period.\n * Female participants must not be pregnant or breast feeding and agree to follow use adequate contraception during the treatment period and for at least 120 days after the last dose of study treatment.\n * Submit an evaluable baseline tumor sample for analysis (either a newly obtained or archival tumor sample).\n\n","\n\n * History of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years.\n * Clinically active central nervous system metastases and/or carcinomatous meningitis.\n * Has had a severe hypersensitivity reaction to treatment with a monoclonal antibody (mAb) and/or other components of the study treatment.\n * Active infection requiring systemic treatment.\n * History of interstitial lung disease.\n * History of (noninfectious) pneumonitis that required steroids or current pneumonitis.\n * Symptomatic ascites or pleural effusion.\n * Previously had a stem cell or bone marrow transplant.\n * Previously had a solid organ transplant.\n * Active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs) except vitiligo or resolved childhood asthma/atopy.\n * Known human immunodeficiency virus (HIV) and/or active and acute Hepatitis B or C infections.\n * Not fully recovered from any effects of major surgery without significant detectable infection.\n * Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study.\n * Had chemotherapy, definitive radiation, or biological cancer therapy within 4 weeks (2 weeks for palliative radiation) before the first dose of study treatment, or has not recovered to Grade â‰¤1 or better from any AEs that were due to cancer therapeutics administered more than 4 weeks earlier.\n * Expected to require any other form of antineoplastic therapy while participating in this study.\n * On chronic systemic steroid therapy in excess of replacement doses (e.g., exceeding 10 mg/day of prednisone equivalent), or on any other form of immunosuppressive medication.\n * Regular user (including \"recreational use\") of any illicit drugs at the time of signing informed consent, or has a recent history (within the last year) of substance abuse (including alcohol), as determined by the treating investigator. Participants who use cannabis for medicinal purposes or to treat specific symptoms will not be excluded unless it is being abused in the opinion of the treating investigator.\n * Received a live-virus vaccine within 28 days before the first dose of study treatment.\n * Currently participating and receiving study treatment in a study of an investigational agent or has participated and received study treatment in a study of an investigational agent or has used an investigational device within 28 days before the first dose of study treatment.",{"$nulls":4},"Actual","2018-01-11","Actual","Anticipated","2020-11-24","Anticipated","2018-06-01","2018-01-04","2018-01-04","2018-06-21","No",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"MK-5890-001","Merck Protocol Number","Dose-limiting Toxicities (DLTs) Graded Using National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 or Later|Adverse Events (AEs)|Study Treatment Discontinuations Due to an AE","A DLT is defined as any of the following toxicities, if assessed by the investigator to be related to study treatment:\n\n * Grade 4 nonhematologic toxicity;\n * Grade 4 hematologic toxicity lasting â‰¥7 days, except thrombocytopenia;\n * Grade 4 thrombocytopenia;\n * Grade 3 thrombocytopenia associated with bleeding that requires a platelet transfusion;\n * Nonhematologic adverse event (AE) Grade â‰¥3 in severity, with exceptions;\n * Grade 3 or 4 nonhematologic laboratory abnormality if: clinically significant medical intervention is required or if abnormality leads to hospitalization, persists for >1 week or results in drug-induced liver injury with exceptions;\n * Grade 3 or Grade 4 febrile neutropenia;\n * Prolonged delay (>2 weeks) in initiating Cycle 2 due to treatment-related toxicity;\n * Treatment-related toxicity resulting in participant study treatment discontinuation during Cycle 1;\n * Missing >25% of the MK-5890 dose during Cycle 1 resulting from treatment-related AE;\n * Grade 5 toxicity.|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience at least one AE will be presented.|The number of participants who discontinue study treatment due to an AE will be presented.","Cycle 1 (Up to 21 days)|Up to 27 months|Up to 24 months","Area Under the Concentration-Time Curve (AUC) of MK-5890 When Administered as Monotherapy and in Combination with Pembrolizumab|Minimum Serum Concentration (Cmin) of MK-5890 When Administered as Monotherapy and in Combination with Pembrolizumab|Maximum Serum Concentration (Cmin) of MK-5890 When Administered as Monotherapy and in Combination with Pembrolizumab","Blood samples will be obtained at designated time points for the assessment of MK-5890 AUC: Cycles 1-4: Day 1: Predose, (end of pembrolizumab infusion for participants receiving pembrolizumab), end of MK-5890 infusion, 2 hours post start of MK-5890 infusion, Days 2, 3, 5, 8 & 15: Once daily; Cycles 5, 6 & every 4 cycles thereafter: Day1: Predose; 30 days post last dose. (Up to 25 months)|Blood samples will be obtained at designated time points for the assessment of MK-5890 Cmin: Cycles 1-4: Day 1: Predose, (end of pembrolizumab infusion for participants receiving pembrolizumab), end of MK-5890 infusion, 2 hours post start of MK-5890 infusion, Days 2, 3, 5, 8 & 15: Once daily; Cycles 5, 6 & every 4 cycles thereafter: Day1: Predose; 30 days post last dose. (Up to 25 months)|Blood samples will be obtained at designated time points for the assessment of MK-5890 Cmax: Cycles 1-4: Day 1: Predose, (end of pembrolizumab infusion for participants receiving pembrolizumab), end of MK-5890 infusion, 2 hours post start of MK-5890 infusion, Days 2, 3, 5, 8 & 15: Once daily; Cycles 5, 6 & every 4 cycles thereafter: Day1: Predose; 30 days post last dose. (Up to 25 months)","At designated time points (Up to 25 months)","Trialsites@merck.com","Toll Free Number","1-888-577-8839","Ramat Gan, Israel, 5265601|Amsterdam, Netherlands, 1066 Cx|Sarasota, Florida, United States, 34232","Florida","Israel|Netherlands|United States","The Chaim Sheba Medical Center - Oncology Institute ( Site 0001)|Antoni Van Leeuwenhoek Ziekenhuis ( Site 0003)|Florida Cancer Specialists ( Site 0002)",{"$nulls":3},"Medical Director","2018-06-21","2020-05-25T16:36:16.273","2020-05-26T17:10:42.972","NCT03396445"]
["5ecbf40311702c1b1b916a34","NCT03396445","2018-12-10","Merck","MRK","Recruiting","Safety and Pharmacokinetics Study of MK-5890 as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Adults With Advanced Solid Tumors (MK-5890-001)","Pembrolizumab","PD-1 Inhibitor","Unknown",null,"Unknown",null,"Phase 1",2,88,"Anticipated","2018-02-18","2020-11-24","DLT","Dose Limiting Toxicity",{"$nulls":3},"The purpose of this study is to assess the safety and pharmacokinetics of MK-5890 when administered alone and in combination with pembrolizumab (MK-3475) in adults with advanced solid tumors. The initial course of MK-5890 monotherapy or MK-5890 plus pembrolizumab combination therapy will be for up to 35 administrations (approximately 2 years).","Participants receiving MK-5890 monotherapy who experience disease progression may be eligible to switch to receiving MK-5890 plus pembrolizumab combination therapy for up to 35 cycles (approximately 2 years) at the discretion of the Investigator and approval of the Sponsor.","A Phase 1 Study of MK-5890 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors","5890-001","Pharmacokinetics\nSolid Tumor","Oncology Solid Tumor Unspecified|Oncology Unspecified|Other","Oncology Solid Tumor|Oncology Unspecified|Other","Oncology|Other","Experimental","MK-5890|MK-5890 + Pembrolizumab","Participants receive escalating doses of MK-5890 via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years).|Participants receive escalating doses of MK-5890 via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years).","Drug|Biological","MK-5890|Pembrolizumab","IV infusion","MK-3475","MK-5890|MK-5890 + Pembrolizumab","\n\n * Histologically or cytologically confirmed advanced/metastatic solid tumor by pathology report and has received or been intolerant to all treatment known to confer clinical benefit.\n * Measureable disease by RECIST 1.1. as assessed by the local site investigator/radiologist. Target lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.\n * Adequate organ function.\n * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n * Male participants must agree to use adequate contraception during the treatment period and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period.\n * Female participants must not be pregnant or breast feeding and agree to follow use adequate contraception during the treatment period and for at least 120 days after the last dose of study treatment.\n * Submit an evaluable baseline tumor sample for analysis (either a newly obtained or archival tumor sample).\n\n","\n\n * History of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years.\n * Clinically active central nervous system metastases and/or carcinomatous meningitis.\n * Has had a severe hypersensitivity reaction to treatment with a monoclonal antibody (mAb) and/or other components of the study treatment.\n * Active infection requiring systemic treatment.\n * History of interstitial lung disease.\n * History of (noninfectious) pneumonitis that required steroids or current pneumonitis.\n * Symptomatic ascites or pleural effusion.\n * Previously had a stem cell or bone marrow transplant.\n * Previously had a solid organ transplant.\n * Active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs) except vitiligo or resolved childhood asthma/atopy.\n * Known human immunodeficiency virus (HIV) and/or active and acute Hepatitis B or C infections.\n * Not fully recovered from any effects of major surgery without significant detectable infection.\n * Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study.\n * Had chemotherapy, definitive radiation, or biological cancer therapy within 4 weeks (2 weeks for palliative radiation) before the first dose of study treatment, or has not recovered to Grade â‰¤1 or better from any AEs that were due to cancer therapeutics administered more than 4 weeks earlier.\n * Expected to require any other form of antineoplastic therapy while participating in this study.\n * On chronic systemic steroid therapy in excess of replacement doses (e.g., exceeding 10 mg/day of prednisone equivalent), or on any other form of immunosuppressive medication.\n * Regular user (including \"recreational use\") of any illicit drugs at the time of signing informed consent, or has a recent history (within the last year) of substance abuse (including alcohol), as determined by the treating investigator. Participants who use cannabis for medicinal purposes or to treat specific symptoms will not be excluded unless it is being abused in the opinion of the treating investigator.\n * Received a live-virus vaccine within 28 days before the first dose of study treatment.\n * Currently participating and receiving study treatment in a study of an investigational agent or has participated and received study treatment in a study of an investigational agent or has used an investigational device within 28 days before the first dose of study treatment.",{"$nulls":4},"Actual","2018-01-11","Actual","Anticipated","2020-11-24","Anticipated","2018-12-01","2018-01-04","2018-01-04","2018-12-06","No",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No","Yes\nhttp://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf",{"$nulls":3},"Yes","No",{"$nulls":17},"MK-5890-001","Merck Protocol Number","Dose-limiting Toxicities (DLTs) Graded Using National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 or Later|Adverse Events (AEs)|Study Treatment Discontinuations Due to an AE","A DLT is defined as any of the following toxicities, if assessed by the investigator to be related to study treatment:\n\n * Grade 4 nonhematologic toxicity;\n * Grade 4 hematologic toxicity lasting â‰¥7 days, except thrombocytopenia;\n * Grade 4 thrombocytopenia;\n * Grade 3 thrombocytopenia associated with bleeding that requires a platelet transfusion;\n * Nonhematologic adverse event (AE) Grade â‰¥3 in severity, with exceptions;\n * Grade 3 or 4 nonhematologic laboratory abnormality if: clinically significant medical intervention is required or if abnormality leads to hospitalization, persists for >1 week or results in drug-induced liver injury with exceptions;\n * Grade 3 or Grade 4 febrile neutropenia;\n * Prolonged delay (>2 weeks) in initiating Cycle 2 due to treatment-related toxicity;\n * Treatment-related toxicity resulting in participant study treatment discontinuation during Cycle 1;\n * Missing >25% of the MK-5890 dose during Cycle 1 resulting from treatment-related AE;\n * Grade 5 toxicity.|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience at least one AE will be presented.|The number of participants who discontinue study treatment due to an AE will be presented.","Cycle 1 (Up to 21 days)|Up to 27 months|Up to 24 months","Area Under the Concentration-Time Curve (AUC) of MK-5890 When Administered as Monotherapy and in Combination with Pembrolizumab|Minimum Serum Concentration (Cmin) of MK-5890 When Administered as Monotherapy and in Combination with Pembrolizumab|Maximum Serum Concentration (Cmin) of MK-5890 When Administered as Monotherapy and in Combination with Pembrolizumab","Blood samples will be obtained at designated time points for the assessment of MK-5890 AUC: Cycles 1-4: Day 1: Predose, (end of pembrolizumab infusion for participants receiving pembrolizumab), end of MK-5890 infusion, 2 hours post start of MK-5890 infusion, Days 2, 3, 5, 8 & 15: Once daily; Cycles 5, 6 & every 4 cycles thereafter: Day1: Predose; 30 days post last dose. (Up to 25 months)|Blood samples will be obtained at designated time points for the assessment of MK-5890 Cmin: Cycles 1-4: Day 1: Predose, (end of pembrolizumab infusion for participants receiving pembrolizumab), end of MK-5890 infusion, 2 hours post start of MK-5890 infusion, Days 2, 3, 5, 8 & 15: Once daily; Cycles 5, 6 & every 4 cycles thereafter: Day1: Predose; 30 days post last dose. (Up to 25 months)|Blood samples will be obtained at designated time points for the assessment of MK-5890 Cmax: Cycles 1-4: Day 1: Predose, (end of pembrolizumab infusion for participants receiving pembrolizumab), end of MK-5890 infusion, 2 hours post start of MK-5890 infusion, Days 2, 3, 5, 8 & 15: Once daily; Cycles 5, 6 & every 4 cycles thereafter: Day1: Predose; 30 days post last dose. (Up to 25 months)","At designated time points (Up to 25 months)","Trialsites@merck.com","Toll Free Number","1-888-577-8839","Ramat Gan, Israel, 5265601|Amsterdam, Netherlands, 1066 Cx|Sarasota, Florida, United States, 34232","Florida","Israel|Netherlands|United States","The Chaim Sheba Medical Center - Oncology Institute ( Site 0001)|Antoni Van Leeuwenhoek Ziekenhuis ( Site 0003)|Florida Cancer Specialists ( Site 0002)",{"$nulls":3},"Medical Director","2018-12-06","2020-05-25T16:36:19.477","2020-05-26T17:10:42.972","NCT03396445"]
["5ecbf400feab101b15530852","NCT03396445","2019-06-14","Merck","MRK","Recruiting","Safety and Pharmacokinetics Study of MK-5890 as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Adults With Advanced Solid Tumors (MK-5890-001)","Pembrolizumab","PD-1 Inhibitor","Unknown",null,"Unknown",null,"Phase 1",2,88,"Anticipated","2018-02-18","2021-07-19","DLT","Dose Limiting Toxicity",{"$nulls":3},"The purpose of this study is to assess the safety and pharmacokinetics of MK-5890 when administered alone and in combination with pembrolizumab (MK-3475) in adults with advanced solid tumors. The initial course of MK-5890 monotherapy or MK-5890 plus pembrolizumab combination therapy will be for up to 35 administrations (approximately 2 years).","Participants receiving MK-5890 monotherapy who experience disease progression may be eligible to switch to receiving MK-5890 plus pembrolizumab combination therapy for up to 35 cycles (approximately 2 years) at the discretion of the Investigator and approval of the Sponsor.","A Phase 1 Study of MK-5890 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors","5890-001","Pharmacokinetics\nSolid Tumor","Oncology Solid Tumor Unspecified|Oncology Unspecified|Other","Oncology Solid Tumor|Oncology Unspecified|Other","Oncology|Other","Experimental","MK-5890|MK-5890 + Pembrolizumab","Participants receive escalating doses of MK-5890 via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years).|Participants receive escalating doses of MK-5890 via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years).","Drug|Biological","MK-5890|Pembrolizumab","IV infusion","MK-3475","MK-5890|MK-5890 + Pembrolizumab","\n\n * Histologically or cytologically confirmed advanced/metastatic solid tumor by pathology report and has received or been intolerant to all treatment known to confer clinical benefit.\n * Measureable disease by RECIST 1.1. as assessed by the local site investigator/radiologist. Target lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.\n * Adequate organ function.\n * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n * Male participants must agree to use adequate contraception during the treatment period and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period.\n * Female participants must not be pregnant or breast feeding and agree to follow use adequate contraception during the treatment period and for at least 120 days after the last dose of study treatment.\n * Submit an evaluable baseline tumor sample for analysis (either a newly obtained or archival tumor sample).\n\n","\n\n * History of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years.\n * Clinically active central nervous system metastases and/or carcinomatous meningitis.\n * Has had a severe hypersensitivity reaction to treatment with a monoclonal antibody (mAb) and/or other components of the study treatment.\n * Active infection requiring systemic treatment.\n * History of interstitial lung disease.\n * History of (noninfectious) pneumonitis that required steroids or current pneumonitis.\n * Symptomatic ascites or pleural effusion.\n * Previously had a stem cell or bone marrow transplant.\n * Previously had a solid organ transplant.\n * Active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs) except vitiligo or resolved childhood asthma/atopy.\n * Known human immunodeficiency virus (HIV) and/or active and acute Hepatitis B or C infections.\n * Not fully recovered from any effects of major surgery without significant detectable infection.\n * Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study.\n * Had chemotherapy, definitive radiation, or biological cancer therapy within 4 weeks (2 weeks for palliative radiation) before the first dose of study treatment, or has not recovered to Grade â‰¤1 or better from any AEs that were due to cancer therapeutics administered more than 4 weeks earlier.\n * Expected to require any other form of antineoplastic therapy while participating in this study.\n * On chronic systemic steroid therapy in excess of replacement doses (e.g., exceeding 10 mg/day of prednisone equivalent), or on any other form of immunosuppressive medication.\n * Regular user (including \"recreational use\") of any illicit drugs at the time of signing informed consent, or has a recent history (within the last year) of substance abuse (including alcohol), as determined by the treating investigator. Participants who use cannabis for medicinal purposes or to treat specific symptoms will not be excluded unless it is being abused in the opinion of the treating investigator.\n * Received a live-virus vaccine within 28 days before the first dose of study treatment.\n * Currently participating and receiving study treatment in a study of an investigational agent or has participated and received study treatment in a study of an investigational agent or has used an investigational device within 28 days before the first dose of study treatment.",{"$nulls":4},"Actual","2018-01-11","Actual","Anticipated","2021-07-19","Anticipated","2019-06-01","2018-01-04","2018-01-04","2019-06-13","No",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No","Yes\nhttp://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf",{"$nulls":3},"Yes","No",{"$nulls":17},"MK-5890-001","Merck Protocol Number","Dose-limiting Toxicities (DLTs) Graded Using National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 or Later|Adverse Events (AEs)|Study Treatment Discontinuations Due to an AE","A DLT is defined as any of the following toxicities, if assessed by the investigator to be related to study treatment:\n\n * Grade 4 nonhematologic toxicity;\n * Grade 4 hematologic toxicity lasting â‰¥7 days, except thrombocytopenia;\n * Grade 4 thrombocytopenia;\n * Grade 3 thrombocytopenia associated with bleeding that requires a platelet transfusion;\n * Nonhematologic adverse event (AE) Grade â‰¥3 in severity, with exceptions;\n * Grade 3 or 4 nonhematologic laboratory abnormality if: clinically significant medical intervention is required or if abnormality leads to hospitalization, persists for >1 week or results in drug-induced liver injury with exceptions;\n * Grade 3 or Grade 4 febrile neutropenia;\n * Prolonged delay (>2 weeks) in initiating Cycle 2 due to treatment-related toxicity;\n * Treatment-related toxicity resulting in participant study treatment discontinuation during Cycle 1;\n * Missing >25% of the MK-5890 dose during Cycle 1 resulting from treatment-related AE;\n * Grade 5 toxicity.|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience at least one AE will be presented.|The number of participants who discontinue study treatment due to an AE will be presented.","Cycle 1 (Up to 21 days)|Up to 27 months|Up to 24 months","Area Under the Concentration-Time Curve (AUC) of MK-5890 When Administered as Monotherapy and in Combination with Pembrolizumab|Minimum Serum Concentration (Cmin) of MK-5890 When Administered as Monotherapy and in Combination with Pembrolizumab|Maximum Serum Concentration (Cmin) of MK-5890 When Administered as Monotherapy and in Combination with Pembrolizumab","Blood samples will be obtained at designated time points for the assessment of MK-5890 AUC: Cycles 1-4: Day 1: Predose, (end of pembrolizumab infusion for participants receiving pembrolizumab), end of MK-5890 infusion, 2 hours post start of MK-5890 infusion, Days 2, 3, 5, 8 & 15: Once daily; Cycles 5, 6 & every 4 cycles thereafter: Day1: Predose; 30 days post last dose. (Up to 25 months)|Blood samples will be obtained at designated time points for the assessment of MK-5890 Cmin: Cycles 1-4: Day 1: Predose, (end of pembrolizumab infusion for participants receiving pembrolizumab), end of MK-5890 infusion, 2 hours post start of MK-5890 infusion, Days 2, 3, 5, 8 & 15: Once daily; Cycles 5, 6 & every 4 cycles thereafter: Day1: Predose; 30 days post last dose. (Up to 25 months)|Blood samples will be obtained at designated time points for the assessment of MK-5890 Cmax: Cycles 1-4: Day 1: Predose, (end of pembrolizumab infusion for participants receiving pembrolizumab), end of MK-5890 infusion, 2 hours post start of MK-5890 infusion, Days 2, 3, 5, 8 & 15: Once daily; Cycles 5, 6 & every 4 cycles thereafter: Day1: Predose; 30 days post last dose. (Up to 25 months)","At designated time points (Up to 25 months)","Trialsites@merck.com","Toll Free Number","1-888-577-8839","Ramat Gan, Israel, 5265601|Amsterdam, Netherlands, 1066 Cx|Sarasota, Florida, United States, 34232","Florida","Israel|Netherlands|United States","The Chaim Sheba Medical Center - Oncology Institute ( Site 0001)|Antoni Van Leeuwenhoek Ziekenhuis ( Site 0003)|Florida Cancer Specialists ( Site 0002)",{"$nulls":3},"Medical Director","2019-06-13","2020-05-25T16:36:16.406","2020-05-26T17:10:42.972","NCT03396445"]
["5ecbf403e2561b1b11905d1e","NCT03396445","2019-07-24","Merck","MRK","Recruiting","Safety and Pharmacokinetics Study of MK-5890 as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Adults With Advanced Solid Tumors (MK-5890-001)","Pembrolizumab|Pemetrexed|Carboplatin","PD-1 Inhibitor|DHFR Antagonist|TS Inhibitor|DNA Synthesis Inhibitor|Mitosis Inhibitor|Tubulin Inhibitor","Unknown",null,"Unknown",null,"Phase 1",3,162,"Anticipated","2018-02-18","2022-07-05","DLT","Dose Limiting Toxicity",{"$nulls":3},"The purpose of this study is to assess the safety and pharmacokinetics of MK-5890 when administered alone and in combination with pembrolizumab (MK-3475) in adults with advanced solid tumors. The initial course of MK-5890 monotherapy or MK-5890 plus pembrolizumab combination therapy will be for up to 35 administrations (approximately 2 years). The safety and pharmacokinetics of MK-5890 when administered with pembrolizumab, pemetrexed and carboplatin will also be assessed in adults with non-squamous non-small cell lung cancer (NSCLC).","Participants receiving MK-5890 monotherapy who experience disease progression may be eligible to switch to receiving MK-5890 plus pembrolizumab combination therapy for up to 35 cycles (approximately 2 years) at the discretion of the Investigator and approval of the Sponsor.","A Phase 1 Study of MK-5890 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors","5890-001","Pharmacokinetics\nSolid Tumor","Oncology Solid Tumor Unspecified|Oncology Unspecified|Other","Oncology Solid Tumor|Oncology Unspecified|Other","Oncology|Other","Experimental","Arm 1: MK-5890|Arm 2: MK-5890 + Pembrolizumab|Arm 3: MK-5890 + Pembrolizumab + Pemetrexed + Carboplatin","Participants receive escalating doses of MK-5890 via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years).|Participants receive escalating doses of MK-5890 via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years).|Participants receive MK-5890 at the selected dose via IV infusion PLUS pembrolizumab 200 mg via IV infusion PLUS pemetrexed 500 mg/m^2 via IV infusion PLUS carboplatin Area Under the Curve (AUC) 5 mg/mL/min via IV infusion, all given on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years).","Drug|Biological","MK-5890|Pembrolizumab|Pemetrexed|Carboplatin","IV infusion","MK-3475|ALIMTAÂ®|PARAPLATINÂ®","Arm 1: MK-5890|Arm 2: MK-5890 + Pembrolizumab|Arm 3: MK-5890 + Pembrolizumab + Pemetrexed + Carboplatin","\n\n * Arms 1 & 2: Histologically or cytologically confirmed advanced/metastatic solid tumor by pathology report and has received or been intolerant to all treatment known to confer clinical benefit.\n * Arm 3: Histologically or cytologically confirmed diagnosis of stage IV (M1a or M1b per current American Joint Committee on Cancer criteria) non-squamous NSCLC.\n * Measureable disease by RECIST 1.1. as assessed by the local site investigator/radiologist. Target lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.\n * Adequate organ function.\n * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n * Male participants must agree to use adequate contraception during the treatment period and for at least 120 days after the last dose of MK-5890 or pembrolizumab OR 180 days after the last dose of chemotherapeutic agents and refrain from donating sperm during this period.\n * Female participants must not be pregnant or breast feeding and agree to follow use adequate contraception during the treatment period and for at least 120 days after the last dose of MK-5890 or pembrolizumab OR 180 days after the last dose of chemotherapeutic agents.\n * Submit an evaluable baseline tumor sample for analysis (either a newly obtained or archival tumor sample).\n\n","\n\n * History of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years.\n * Clinically active central nervous system metastases and/or carcinomatous meningitis.\n * Has had a severe hypersensitivity reaction to treatment with a monoclonal antibody (mAb) and/or other components of the study treatment.\n * Active infection requiring systemic treatment.\n * History of interstitial lung disease.\n * History of (noninfectious) pneumonitis that required steroids or current pneumonitis.\n * Symptomatic ascites or pleural effusion.\n * Previously had a stem cell or bone marrow transplant.\n * Previously had a solid organ transplant.\n * Active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs) except vitiligo or resolved childhood asthma/atopy.\n * Known human immunodeficiency virus (HIV) and/or active and acute Hepatitis B or C infections.\n * Not fully recovered from any effects of major surgery without significant detectable infection.\n * Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study.\n * Had chemotherapy, definitive radiation, or biological cancer therapy within 4 weeks (2 weeks for palliative radiation) before the first dose of study treatment, or has not recovered to Grade â‰¤1 or better from any AEs that were due to cancer therapeutics administered more than 4 weeks earlier.\n * Expected to require any other form of antineoplastic therapy while participating in this study.\n * On chronic systemic steroid therapy in excess of replacement doses (e.g., exceeding 10 mg/day of prednisone equivalent), or on any other form of immunosuppressive medication.\n * Regular user (including \"recreational use\") of any illicit drugs at the time of signing informed consent, or has a recent history (within the last year) of substance abuse (including alcohol), as determined by the treating investigator. Participants who use cannabis for medicinal purposes or to treat specific symptoms will not be excluded unless it is being abused in the opinion of the treating investigator.\n * Received a live-virus vaccine within 28 days before the first dose of study treatment.\n * Currently participating and receiving study treatment in a study of an investigational agent or has participated and received study treatment in a study of an investigational agent or has used an investigational device within 28 days before the first dose of study treatment.\n\nAdditional Exclusion Criteria for Participants in Arm 3:\n\n * Has received radiation therapy to the lung that is >30 Gray (Gy) within 6 months before the first dose of study treatment.\n * Is unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs), other than an aspirin dose â‰¤1.3 g per day, for a 5-day period (8-day period for long-acting agents, such as piroxicam).\n * Is unable or unwilling to take folic acid or vitamin B12 supplementation.",{"$nulls":4},"Actual","2018-01-11","Actual","Anticipated","2022-07-05","Anticipated","2019-07-01","2018-01-04","2018-01-04","2019-07-23","No",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No","Yes\nhttp://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf",{"$nulls":3},"Yes","No",{"$nulls":17},"MK-5890-001","Merck Protocol Number","Arms 1 and 2: Dose-limiting Toxicities (DLTs) Graded Using National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 or Later|Arms 1 and 2: Number of Participants with Adverse Events (AEs)|Arms 1 and 2: Number of Study Treatment Discontinuations Due to an Adverse Event (AE)","A DLT is defined as any of the following toxicities, if assessed by the investigator to be related to study treatment:\n\n * Grade 4 nonhematologic toxicity;\n * Grade 4 hematologic toxicity lasting â‰¥7 days, except thrombocytopenia;\n * Grade 4 thrombocytopenia;\n * Grade 3 thrombocytopenia associated with bleeding that requires a platelet transfusion;\n * Nonhematologic adverse event (AE) Grade â‰¥3 in severity, with exceptions;\n * Grade 3 or 4 nonhematologic laboratory abnormality if: clinically significant medical intervention is required or if abnormality leads to hospitalization, persists for >1 week or results in drug-induced liver injury with exceptions;\n * Grade 3 or Grade 4 febrile neutropenia;\n * Prolonged delay (>2 weeks) in initiating Cycle 2 due to treatment-related toxicity;\n * Treatment-related toxicity resulting in participant study treatment discontinuation during Cycle 1;\n * Missing >25% of the MK-5890 dose during Cycle 1 resulting from treatment-related AE;\n * Grade 5 toxicity.|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants in Arms 1 and 2 who experience at least one AE will be presented.|The number of participants in Arms 1 and 2 who discontinue study treatment due to an AE will be presented.","Cycle 1 (Up to 21 days)|Up to 27 months|Up to 24 months","All Arms: Area Under the Concentration-Time Curve (AUC) of MK-5890|All Arms: Minimum Serum Concentration (Cmin) of MK-5890|All Arms: Maximum Serum Concentration (Cmax) of MK-5890|Arms 1 and 2: Objective Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)|Arm 3: Dose-limiting Toxicities (DLTs) Graded Using National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 or Later|Arm 3: Number of Participants with Adverse Events (AEs)|Arm 3: Number of Study Treatment Discontinuations Due to an Adverse Event (AE)","Blood samples will be obtained at designated time points for the assessment of MK-5890 AUC: Cycles 1-4: Day 1: Predose, (end of pembrolizumab infusion for participants receiving pembrolizumab), end of MK-5890 infusion, 2 hours post start of MK-5890 infusion, Days 2, 3, 5, 8 & 15: Once daily; Cycles 5, 6 & every 4 cycles thereafter: Day1: Predose; 30 days post last dose. Each cycle is 21 days. (Up to 25 months)|Blood samples will be obtained at designated time points for the assessment of MK-5890 Cmin: Cycles 1-4: Day 1: Predose, (end of pembrolizumab infusion for participants receiving pembrolizumab), end of MK-5890 infusion, 2 hours post start of MK-5890 infusion, Days 2, 3, 5, 8 & 15: Once daily; Cycles 5, 6 & every 4 cycles thereafter: Day1: Predose; 30 days post last dose. Each cycle is 21 days. (Up to 25 months)|Blood samples will be obtained at designated time points for the assessment of MK-5890 Cmax: Cycles 1-4: Day 1: Predose, (end of pembrolizumab infusion for participants receiving pembrolizumab), end of MK-5890 infusion, 2 hours post start of MK-5890 infusion, Days 2, 3, 5, 8 & 15: Once daily; Cycles 5, 6 & every 4 cycles thereafter: Day1: Predose; 30 days post last dose. Each cycle is 21 days. (Up to 25 months)|The ORR is defined as the percentage of participants who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. The ORR of MK-5890 when used as monotherapy and in combination with pembrolizumab (Arms 1 and 2) as assessed by the investigator will be presented.|A DLT is defined as any of the following toxicities, if assessed by the investigator to be related to study treatment:\n\n * Grade 4 nonhematologic toxicity;\n * Grade 4 hematologic toxicity lasting â‰¥7 days, except thrombocytopenia;\n * Grade 4 thrombocytopenia;\n * Grade 3 thrombocytopenia associated with bleeding that requires a platelet transfusion;\n * Nonhematologic adverse event (AE) Grade â‰¥3 in severity, with exceptions;\n * Grade 3 or 4 nonhematologic laboratory abnormality if: clinically significant medical intervention is required or if abnormality leads to hospitalization, persists for >1 week or results in drug-induced liver injury with exceptions;\n * Grade 3 or Grade 4 febrile neutropenia;\n * Prolonged delay (>2 weeks) in initiating Cycle 2 due to treatment-related toxicity;\n * Treatment-related toxicity resulting in participant study treatment discontinuation during Cycle 1;\n * Missing >25% of the MK-5890 dose during Cycle 1 resulting from treatment-related AE;\n * Grade 5 toxicity.|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants in Arm 3 who experience at least one AE will be presented.|The number of participants in Arm 3 who discontinue study treatment due to an AE will be presented.","At designated time points (Up to 25 months)|Up to 24 months|Cycle 1 (Up to 21 days)|Up to 27 months","Trialsites@merck.com","Toll Free Number","1-888-577-8839","Ramat Gan, Israel, 5265601|Amsterdam, Netherlands, 1066 Cx|Sarasota, Florida, United States, 34232","Florida","Israel|Netherlands|United States","The Chaim Sheba Medical Center - Oncology Institute ( Site 0001)|Antoni Van Leeuwenhoek Ziekenhuis ( Site 0003)|Florida Cancer Specialists ( Site 0002)",{"$nulls":3},"Medical Director","2019-07-23","2020-05-25T16:36:19.367","2020-05-26T17:10:42.972","NCT03396445"]
["5ecbf403fe30261b1a048222","NCT03396445","2019-10-17","Merck","MRK","Recruiting","Safety and Pharmacokinetics Study of MK-5890 as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Adults With Advanced Solid Tumors (MK-5890-001)","Pembrolizumab|Pemetrexed|Carboplatin","PD-1 Inhibitor|DHFR Antagonist|TS Inhibitor|DNA Synthesis Inhibitor|Mitosis Inhibitor|Tubulin Inhibitor","Unknown",null,"Unknown",null,"Phase 1",3,162,"Anticipated","2018-02-18","2022-07-05","DLT","Dose Limiting Toxicity",{"$nulls":3},"The purpose of this study is to assess the safety and pharmacokinetics of MK-5890 when administered alone and in combination with pembrolizumab (MK-3475) in adults with advanced solid tumors. The initial course of MK-5890 monotherapy or MK-5890 plus pembrolizumab combination therapy will be for up to 35 administrations (approximately 2 years). The safety and pharmacokinetics of MK-5890 when administered with pembrolizumab, pemetrexed and carboplatin will also be assessed in adults with non-squamous non-small cell lung cancer (NSCLC).","Participants receiving MK-5890 monotherapy who experience disease progression may be eligible to switch to receiving MK-5890 plus pembrolizumab combination therapy for up to 35 cycles (approximately 2 years) at the discretion of the Investigator and approval of the Sponsor.","A Phase 1 Study of MK-5890 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors","5890-001","Pharmacokinetics\nSolid Tumor","Oncology Solid Tumor Unspecified|Oncology Unspecified|Other","Oncology Solid Tumor|Oncology Unspecified|Other","Oncology|Other","Experimental","Arm 1: MK-5890|Arm 2: MK-5890 + Pembrolizumab|Arm 3: MK-5890 + Pembrolizumab + Pemetrexed + Carboplatin","Participants receive escalating doses of MK-5890 via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years).|Participants receive escalating doses of MK-5890 via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years).|Participants receive MK-5890 at the selected dose via IV infusion PLUS pembrolizumab 200 mg via IV infusion PLUS pemetrexed 500 mg/m^2 via IV infusion PLUS carboplatin Area Under the Curve (AUC) 5 mg/mL/min via IV infusion, all given on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years).","Drug|Biological","MK-5890|Pembrolizumab|Pemetrexed|Carboplatin","IV infusion","MK-3475|ALIMTAÂ®|PARAPLATINÂ®","Arm 1: MK-5890|Arm 2: MK-5890 + Pembrolizumab|Arm 3: MK-5890 + Pembrolizumab + Pemetrexed + Carboplatin","\n\n * Arms 1 & 2: Histologically or cytologically confirmed advanced/metastatic solid tumor by pathology report and has received or been intolerant to all treatment known to confer clinical benefit.\n * Arm 3: Histologically or cytologically confirmed diagnosis of stage IV (M1a or M1b per current American Joint Committee on Cancer criteria) non-squamous NSCLC.\n * Measureable disease by RECIST 1.1. as assessed by the local site investigator/radiologist. Target lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.\n * Adequate organ function.\n * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n * Male participants must agree to use adequate contraception during the treatment period and for at least 120 days after the last dose of MK-5890 or pembrolizumab OR 180 days after the last dose of chemotherapeutic agents and refrain from donating sperm during this period.\n * Female participants must not be pregnant or breast feeding and agree to follow use adequate contraception during the treatment period and for at least 120 days after the last dose of MK-5890 or pembrolizumab OR 180 days after the last dose of chemotherapeutic agents.\n * Submit an evaluable baseline tumor sample for analysis (either a newly obtained or archival tumor sample).\n\n","\n\n * History of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years.\n * Clinically active central nervous system metastases and/or carcinomatous meningitis.\n * Has had a severe hypersensitivity reaction to treatment with a monoclonal antibody (mAb) and/or other components of the study treatment.\n * Active infection requiring systemic treatment.\n * History of interstitial lung disease.\n * History of (noninfectious) pneumonitis that required steroids or current pneumonitis.\n * Symptomatic ascites or pleural effusion.\n * Previously had a stem cell or bone marrow transplant.\n * Previously had a solid organ transplant.\n * Active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs) except vitiligo or resolved childhood asthma/atopy.\n * Known human immunodeficiency virus (HIV) and/or active and acute Hepatitis B or C infections.\n * Not fully recovered from any effects of major surgery without significant detectable infection.\n * Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study.\n * Had chemotherapy, definitive radiation, or biological cancer therapy within 4 weeks (2 weeks for palliative radiation) before the first dose of study treatment, or has not recovered to Grade â‰¤1 or better from any AEs that were due to cancer therapeutics administered more than 4 weeks earlier.\n * Expected to require any other form of antineoplastic therapy while participating in this study.\n * On chronic systemic steroid therapy in excess of replacement doses (e.g., exceeding 10 mg/day of prednisone equivalent), or on any other form of immunosuppressive medication.\n * Regular user (including \"recreational use\") of any illicit drugs at the time of signing informed consent, or has a recent history (within the last year) of substance abuse (including alcohol), as determined by the treating investigator. Participants who use cannabis for medicinal purposes or to treat specific symptoms will not be excluded unless it is being abused in the opinion of the treating investigator.\n * Received a live-virus vaccine within 28 days before the first dose of study treatment.\n * Currently participating and receiving study treatment in a study of an investigational agent or has participated and received study treatment in a study of an investigational agent or has used an investigational device within 28 days before the first dose of study treatment.\n\nAdditional Exclusion Criteria for Participants in Arm 3:\n\n * Has received radiation therapy to the lung that is >30 Gray (Gy) within 6 months before the first dose of study treatment.\n * Is unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs), other than an aspirin dose â‰¤1.3 g per day, for a 5-day period (8-day period for long-acting agents, such as piroxicam).\n * Is unable or unwilling to take folic acid or vitamin B12 supplementation.",{"$nulls":4},"Actual","2018-01-11","Actual","Anticipated","2022-07-05","Anticipated","2019-10-01","2018-01-04","2018-01-04","2019-10-16","No",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No","Yes\nhttp://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf",{"$nulls":3},"Yes","No",{"$nulls":17},"MK-5890-001","Merck Protocol Number","Arms 1 and 2: Dose-limiting Toxicities (DLTs) Graded Using National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 or Later|Arms 1 and 2: Number of Participants with Adverse Events (AEs)|Arms 1 and 2: Number of Study Treatment Discontinuations Due to an Adverse Event (AE)","A DLT is defined as any of the following toxicities, if assessed by the investigator to be related to study treatment:\n\n * Grade 4 nonhematologic toxicity;\n * Grade 4 hematologic toxicity lasting â‰¥7 days, except thrombocytopenia;\n * Grade 4 thrombocytopenia;\n * Grade 3 thrombocytopenia associated with bleeding that requires a platelet transfusion;\n * Nonhematologic adverse event (AE) Grade â‰¥3 in severity, with exceptions;\n * Grade 3 or 4 nonhematologic laboratory abnormality if: clinically significant medical intervention is required or if abnormality leads to hospitalization, persists for >1 week or results in drug-induced liver injury with exceptions;\n * Grade 3 or Grade 4 febrile neutropenia;\n * Prolonged delay (>2 weeks) in initiating Cycle 2 due to treatment-related toxicity;\n * Treatment-related toxicity resulting in participant study treatment discontinuation during Cycle 1;\n * Missing >25% of the MK-5890 dose during Cycle 1 resulting from treatment-related AE;\n * Grade 5 toxicity.|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants in Arms 1 and 2 who experience at least one AE will be presented.|The number of participants in Arms 1 and 2 who discontinue study treatment due to an AE will be presented.","Cycle 1 (Up to 21 days)|Up to 27 months|Up to 24 months","All Arms: Area Under the Concentration-Time Curve (AUC) of MK-5890|All Arms: Minimum Serum Concentration (Cmin) of MK-5890|All Arms: Maximum Serum Concentration (Cmax) of MK-5890|Arms 1 and 2: Objective Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)|Arm 3: Dose-limiting Toxicities (DLTs) Graded Using National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 or Later|Arm 3: Number of Participants with Adverse Events (AEs)|Arm 3: Number of Study Treatment Discontinuations Due to an Adverse Event (AE)","Blood samples will be obtained at designated time points for the assessment of MK-5890 AUC: Cycles 1-4: Day 1: Predose, (end of pembrolizumab infusion for participants receiving pembrolizumab), end of MK-5890 infusion, 2 hours post start of MK-5890 infusion, Days 2, 3, 5, 8 & 15: Once daily; Cycles 5, 6 & every 4 cycles thereafter: Day1: Predose; 30 days post last dose. Each cycle is 21 days. (Up to 25 months)|Blood samples will be obtained at designated time points for the assessment of MK-5890 Cmin: Cycles 1-4: Day 1: Predose, (end of pembrolizumab infusion for participants receiving pembrolizumab), end of MK-5890 infusion, 2 hours post start of MK-5890 infusion, Days 2, 3, 5, 8 & 15: Once daily; Cycles 5, 6 & every 4 cycles thereafter: Day1: Predose; 30 days post last dose. Each cycle is 21 days. (Up to 25 months)|Blood samples will be obtained at designated time points for the assessment of MK-5890 Cmax: Cycles 1-4: Day 1: Predose, (end of pembrolizumab infusion for participants receiving pembrolizumab), end of MK-5890 infusion, 2 hours post start of MK-5890 infusion, Days 2, 3, 5, 8 & 15: Once daily; Cycles 5, 6 & every 4 cycles thereafter: Day1: Predose; 30 days post last dose. Each cycle is 21 days. (Up to 25 months)|The ORR is defined as the percentage of participants who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. The ORR of MK-5890 when used as monotherapy and in combination with pembrolizumab (Arms 1 and 2) as assessed by the investigator will be presented.|A DLT is defined as any of the following toxicities, if assessed by the investigator to be related to study treatment:\n\n * Grade 4 nonhematologic toxicity;\n * Grade 4 hematologic toxicity lasting â‰¥7 days, except thrombocytopenia;\n * Grade 4 thrombocytopenia;\n * Grade 3 thrombocytopenia associated with bleeding that requires a platelet transfusion;\n * Nonhematologic adverse event (AE) Grade â‰¥3 in severity, with exceptions;\n * Grade 3 or 4 nonhematologic laboratory abnormality if: clinically significant medical intervention is required or if abnormality leads to hospitalization, persists for >1 week or results in drug-induced liver injury with exceptions;\n * Grade 3 or Grade 4 febrile neutropenia;\n * Prolonged delay (>2 weeks) in initiating Cycle 2 due to treatment-related toxicity;\n * Treatment-related toxicity resulting in participant study treatment discontinuation during Cycle 1;\n * Missing >25% of the MK-5890 dose during Cycle 1 resulting from treatment-related AE;\n * Grade 5 toxicity.|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants in Arm 3 who experience at least one AE will be presented.|The number of participants in Arm 3 who discontinue study treatment due to an AE will be presented.","At designated time points (Up to 25 months)|Up to 24 months|Cycle 1 (Up to 21 days)|Up to 27 months","Trialsites@merck.com","Toll Free Number","1-888-577-8839","Ramat Gan, Israel, 5265601|Amsterdam, Netherlands, 1066 Cx|Mobile, Alabama, United States, 36604|Sarasota, Florida, United States, 34232","Alabama|Florida","Israel|Netherlands|United States","The Chaim Sheba Medical Center - Oncology Institute ( Site 0001)|Antoni Van Leeuwenhoek Ziekenhuis ( Site 0003)|University Of South Alabama, Mitchell Cancer Institute ( Site 0020)|Florida Cancer Specialists ( Site 0002)",{"$nulls":3},"Medical Director","2019-10-16","2020-05-25T16:36:19.036","2020-05-26T17:10:42.972","NCT03396445"]
["5ecbf403307e3d1b1f8d9cb3","NCT03396445","2019-10-31","Merck","MRK","Recruiting","Safety and Pharmacokinetics Study of MK-5890 as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Adults With Advanced Solid Tumors (MK-5890-001)","Pembrolizumab|Pemetrexed|Carboplatin","PD-1 Inhibitor|DHFR Antagonist|TS Inhibitor|DNA Synthesis Inhibitor|Mitosis Inhibitor|Tubulin Inhibitor","Unknown",null,"Unknown",null,"Phase 1",3,162,"Anticipated","2018-02-18","2022-07-05","DLT","Dose Limiting Toxicity",{"$nulls":3},"The purpose of this study is to assess the safety and pharmacokinetics of MK-5890 when administered alone and in combination with pembrolizumab (MK-3475) in adults with advanced solid tumors. The initial course of MK-5890 monotherapy or MK-5890 plus pembrolizumab combination therapy will be for up to 35 administrations (approximately 2 years). The safety and pharmacokinetics of MK-5890 when administered with pembrolizumab, pemetrexed and carboplatin will also be assessed in adults with non-squamous non-small cell lung cancer (NSCLC).","Participants receiving MK-5890 monotherapy who experience disease progression may be eligible to switch to receiving MK-5890 plus pembrolizumab combination therapy for up to 35 cycles (approximately 2 years) at the discretion of the Investigator and approval of the Sponsor.","A Phase 1 Study of MK-5890 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors","5890-001","Pharmacokinetics\nSolid Tumor","Oncology Solid Tumor Unspecified|Oncology Unspecified|Other","Oncology Solid Tumor|Oncology Unspecified|Other","Oncology|Other","Experimental","Arm 1: MK-5890|Arm 2: MK-5890 + Pembrolizumab|Arm 3: MK-5890 + Pembrolizumab + Pemetrexed + Carboplatin","Participants receive escalating doses of MK-5890 via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years).|Participants receive escalating doses of MK-5890 via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years).|Participants receive MK-5890 at the selected dose via IV infusion PLUS pembrolizumab 200 mg via IV infusion PLUS pemetrexed 500 mg/m^2 via IV infusion PLUS carboplatin Area Under the Curve (AUC) 5 mg/mL/min via IV infusion, all given on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years).","Drug|Biological","MK-5890|Pembrolizumab|Pemetrexed|Carboplatin","IV infusion","MK-3475|ALIMTAÂ®|PARAPLATINÂ®","Arm 1: MK-5890|Arm 2: MK-5890 + Pembrolizumab|Arm 3: MK-5890 + Pembrolizumab + Pemetrexed + Carboplatin","\n\n * Arms 1 & 2: Histologically or cytologically confirmed advanced/metastatic solid tumor by pathology report and has received or been intolerant to all treatment known to confer clinical benefit.\n * Arm 3: Histologically or cytologically confirmed diagnosis of stage IV (M1a or M1b per current American Joint Committee on Cancer criteria) non-squamous NSCLC.\n * Measureable disease by RECIST 1.1. as assessed by the local site investigator/radiologist. Target lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.\n * Adequate organ function.\n * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n * Male participants must agree to use adequate contraception during the treatment period and for at least 120 days after the last dose of MK-5890 or pembrolizumab OR 180 days after the last dose of chemotherapeutic agents and refrain from donating sperm during this period.\n * Female participants must not be pregnant or breast feeding and agree to follow use adequate contraception during the treatment period and for at least 120 days after the last dose of MK-5890 or pembrolizumab OR 180 days after the last dose of chemotherapeutic agents.\n * Submit an evaluable baseline tumor sample for analysis (either a newly obtained or archival tumor sample).\n\n","\n\n * History of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years.\n * Clinically active central nervous system metastases and/or carcinomatous meningitis.\n * Has had a severe hypersensitivity reaction to treatment with a monoclonal antibody (mAb) and/or other components of the study treatment.\n * Active infection requiring systemic treatment.\n * History of interstitial lung disease.\n * History of (noninfectious) pneumonitis that required steroids or current pneumonitis.\n * Symptomatic ascites or pleural effusion.\n * Previously had a stem cell or bone marrow transplant.\n * Previously had a solid organ transplant.\n * Active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs) except vitiligo or resolved childhood asthma/atopy.\n * Known human immunodeficiency virus (HIV) and/or active and acute Hepatitis B or C infections.\n * Not fully recovered from any effects of major surgery without significant detectable infection.\n * Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study.\n * Had chemotherapy, definitive radiation, or biological cancer therapy within 4 weeks (2 weeks for palliative radiation) before the first dose of study treatment, or has not recovered to Grade â‰¤1 or better from any AEs that were due to cancer therapeutics administered more than 4 weeks earlier.\n * Expected to require any other form of antineoplastic therapy while participating in this study.\n * On chronic systemic steroid therapy in excess of replacement doses (e.g., exceeding 10 mg/day of prednisone equivalent), or on any other form of immunosuppressive medication.\n * Regular user (including \"recreational use\") of any illicit drugs at the time of signing informed consent, or has a recent history (within the last year) of substance abuse (including alcohol), as determined by the treating investigator. Participants who use cannabis for medicinal purposes or to treat specific symptoms will not be excluded unless it is being abused in the opinion of the treating investigator.\n * Received a live-virus vaccine within 28 days before the first dose of study treatment.\n * Currently participating and receiving study treatment in a study of an investigational agent or has participated and received study treatment in a study of an investigational agent or has used an investigational device within 28 days before the first dose of study treatment.\n\nAdditional Exclusion Criteria for Participants in Arm 3:\n\n * Has received radiation therapy to the lung that is >30 Gray (Gy) within 6 months before the first dose of study treatment.\n * Is unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs), other than an aspirin dose â‰¤1.3 g per day, for a 5-day period (8-day period for long-acting agents, such as piroxicam).\n * Is unable or unwilling to take folic acid or vitamin B12 supplementation.",{"$nulls":4},"Actual","2018-01-11","Actual","Anticipated","2022-07-05","Anticipated","2019-10-01","2018-01-04","2018-01-04","2019-10-30","No",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No","Yes\nhttp://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf",{"$nulls":3},"Yes","No",{"$nulls":17},"MK-5890-001","Merck Protocol Number","Arms 1 and 2: Dose-limiting Toxicities (DLTs) Graded Using National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 or Later|Arms 1 and 2: Number of Participants with Adverse Events (AEs)|Arms 1 and 2: Number of Study Treatment Discontinuations Due to an Adverse Event (AE)","A DLT is defined as any of the following toxicities, if assessed by the investigator to be related to study treatment:\n\n * Grade 4 nonhematologic toxicity;\n * Grade 4 hematologic toxicity lasting â‰¥7 days, except thrombocytopenia;\n * Grade 4 thrombocytopenia;\n * Grade 3 thrombocytopenia associated with bleeding that requires a platelet transfusion;\n * Nonhematologic adverse event (AE) Grade â‰¥3 in severity, with exceptions;\n * Grade 3 or 4 nonhematologic laboratory abnormality if: clinically significant medical intervention is required or if abnormality leads to hospitalization, persists for >1 week or results in drug-induced liver injury with exceptions;\n * Grade 3 or Grade 4 febrile neutropenia;\n * Prolonged delay (>2 weeks) in initiating Cycle 2 due to treatment-related toxicity;\n * Treatment-related toxicity resulting in participant study treatment discontinuation during Cycle 1;\n * Missing >25% of the MK-5890 dose during Cycle 1 resulting from treatment-related AE;\n * Grade 5 toxicity.|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants in Arms 1 and 2 who experience at least one AE will be presented.|The number of participants in Arms 1 and 2 who discontinue study treatment due to an AE will be presented.","Cycle 1 (Up to 21 days)|Up to 27 months|Up to 24 months","All Arms: Area Under the Concentration-Time Curve (AUC) of MK-5890|All Arms: Minimum Serum Concentration (Cmin) of MK-5890|All Arms: Maximum Serum Concentration (Cmax) of MK-5890|Arms 1 and 2: Objective Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)|Arm 3: Dose-limiting Toxicities (DLTs) Graded Using National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 or Later|Arm 3: Number of Participants with Adverse Events (AEs)|Arm 3: Number of Study Treatment Discontinuations Due to an Adverse Event (AE)","Blood samples will be obtained at designated time points for the assessment of MK-5890 AUC: Cycles 1-4: Day 1: Predose, (end of pembrolizumab infusion for participants receiving pembrolizumab), end of MK-5890 infusion, 2 hours post start of MK-5890 infusion, Days 2, 3, 5, 8 & 15: Once daily; Cycles 5, 6 & every 4 cycles thereafter: Day1: Predose; 30 days post last dose. Each cycle is 21 days. (Up to 25 months)|Blood samples will be obtained at designated time points for the assessment of MK-5890 Cmin: Cycles 1-4: Day 1: Predose, (end of pembrolizumab infusion for participants receiving pembrolizumab), end of MK-5890 infusion, 2 hours post start of MK-5890 infusion, Days 2, 3, 5, 8 & 15: Once daily; Cycles 5, 6 & every 4 cycles thereafter: Day1: Predose; 30 days post last dose. Each cycle is 21 days. (Up to 25 months)|Blood samples will be obtained at designated time points for the assessment of MK-5890 Cmax: Cycles 1-4: Day 1: Predose, (end of pembrolizumab infusion for participants receiving pembrolizumab), end of MK-5890 infusion, 2 hours post start of MK-5890 infusion, Days 2, 3, 5, 8 & 15: Once daily; Cycles 5, 6 & every 4 cycles thereafter: Day1: Predose; 30 days post last dose. Each cycle is 21 days. (Up to 25 months)|The ORR is defined as the percentage of participants who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. The ORR of MK-5890 when used as monotherapy and in combination with pembrolizumab (Arms 1 and 2) as assessed by the investigator will be presented.|A DLT is defined as any of the following toxicities, if assessed by the investigator to be related to study treatment:\n\n * Grade 4 nonhematologic toxicity;\n * Grade 4 hematologic toxicity lasting â‰¥7 days, except thrombocytopenia;\n * Grade 4 thrombocytopenia;\n * Grade 3 thrombocytopenia associated with bleeding that requires a platelet transfusion;\n * Nonhematologic adverse event (AE) Grade â‰¥3 in severity, with exceptions;\n * Grade 3 or 4 nonhematologic laboratory abnormality if: clinically significant medical intervention is required or if abnormality leads to hospitalization, persists for >1 week or results in drug-induced liver injury with exceptions;\n * Grade 3 or Grade 4 febrile neutropenia;\n * Prolonged delay (>2 weeks) in initiating Cycle 2 due to treatment-related toxicity;\n * Treatment-related toxicity resulting in participant study treatment discontinuation during Cycle 1;\n * Missing >25% of the MK-5890 dose during Cycle 1 resulting from treatment-related AE;\n * Grade 5 toxicity.|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants in Arm 3 who experience at least one AE will be presented.|The number of participants in Arm 3 who discontinue study treatment due to an AE will be presented.","At designated time points (Up to 25 months)|Up to 24 months|Cycle 1 (Up to 21 days)|Up to 27 months","Trialsites@merck.com","Toll Free Number","1-888-577-8839","Jerusalem, Israel, 9112001|Amsterdam, Netherlands, 1066 Cx|Barcelona, Spain, 08916|Mobile, Alabama, United States, 36604|Sarasota, Florida, United States, 34232","Alabama|Florida","Israel|Netherlands|Spain|United States","Hadassah Ein Kerem Medical Center ( Site 0010)|Antoni Van Leeuwenhoek Ziekenhuis ( Site 0003)|Instituto Catalan De Oncologia - Ico ( Site 0044)|University Of South Alabama, Mitchell Cancer Institute ( Site 0020)|Florida Cancer Specialists ( Site 0002)",{"$nulls":3},"Medical Director","2019-10-30","2020-05-25T16:36:19.058","2020-05-26T17:10:42.972","NCT03396445"]
["5ecbf40311702c1b1b916a33","NCT03396445","2019-11-08","Merck","MRK","Recruiting","Safety and Pharmacokinetics Study of MK-5890 as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Adults With Advanced Solid Tumors (MK-5890-001)","Pembrolizumab|Pemetrexed|Carboplatin","PD-1 Inhibitor|DHFR Antagonist|TS Inhibitor|DNA Synthesis Inhibitor|Mitosis Inhibitor|Tubulin Inhibitor","Unknown",null,"Unknown",null,"Phase 1",3,162,"Anticipated","2018-02-18","2022-07-05","DLT","Dose Limiting Toxicity",{"$nulls":3},"The purpose of this study is to assess the safety and pharmacokinetics of MK-5890 when administered alone and in combination with pembrolizumab (MK-3475) in adults with advanced solid tumors. The initial course of MK-5890 monotherapy or MK-5890 plus pembrolizumab combination therapy will be for up to 35 administrations (approximately 2 years). The safety and pharmacokinetics of MK-5890 when administered with pembrolizumab, pemetrexed and carboplatin will also be assessed in adults with non-squamous non-small cell lung cancer (NSCLC).","Participants receiving MK-5890 monotherapy who experience disease progression may be eligible to switch to receiving MK-5890 plus pembrolizumab combination therapy for up to 35 cycles (approximately 2 years) at the discretion of the Investigator and approval of the Sponsor.","A Phase 1 Study of MK-5890 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors","5890-001","Pharmacokinetics\nSolid Tumor","Oncology Solid Tumor Unspecified|Oncology Unspecified|Other","Oncology Solid Tumor|Oncology Unspecified|Other","Oncology|Other","Experimental","Arm 1: MK-5890|Arm 2: MK-5890 + Pembrolizumab|Arm 3: MK-5890 + Pembrolizumab + Pemetrexed + Carboplatin","Participants receive escalating doses of MK-5890 via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years).|Participants receive escalating doses of MK-5890 via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years).|Participants receive MK-5890 at the selected dose via IV infusion PLUS pembrolizumab 200 mg via IV infusion PLUS pemetrexed 500 mg/m^2 via IV infusion PLUS carboplatin Area Under the Curve (AUC) 5 mg/mL/min via IV infusion, all given on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years).","Drug|Biological","MK-5890|Pembrolizumab|Pemetrexed|Carboplatin","IV infusion","MK-3475|ALIMTAÂ®|PARAPLATINÂ®","Arm 1: MK-5890|Arm 2: MK-5890 + Pembrolizumab|Arm 3: MK-5890 + Pembrolizumab + Pemetrexed + Carboplatin","\n\n * Arms 1 & 2: Histologically or cytologically confirmed advanced/metastatic solid tumor by pathology report and has received or been intolerant to all treatment known to confer clinical benefit.\n * Arm 3: Histologically or cytologically confirmed diagnosis of stage IV (M1a or M1b per current American Joint Committee on Cancer criteria) non-squamous NSCLC.\n * Measureable disease by RECIST 1.1. as assessed by the local site investigator/radiologist. Target lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.\n * Adequate organ function.\n * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n * Male participants must agree to use adequate contraception during the treatment period and for at least 120 days after the last dose of MK-5890 or pembrolizumab OR 180 days after the last dose of chemotherapeutic agents and refrain from donating sperm during this period.\n * Female participants must not be pregnant or breast feeding and agree to follow use adequate contraception during the treatment period and for at least 120 days after the last dose of MK-5890 or pembrolizumab OR 180 days after the last dose of chemotherapeutic agents.\n * Submit an evaluable baseline tumor sample for analysis (either a newly obtained or archival tumor sample).\n\n","\n\n * History of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years.\n * Clinically active central nervous system metastases and/or carcinomatous meningitis.\n * Has had a severe hypersensitivity reaction to treatment with a monoclonal antibody (mAb) and/or other components of the study treatment.\n * Active infection requiring systemic treatment.\n * History of interstitial lung disease.\n * History of (noninfectious) pneumonitis that required steroids or current pneumonitis.\n * Symptomatic ascites or pleural effusion.\n * Previously had a stem cell or bone marrow transplant.\n * Previously had a solid organ transplant.\n * Active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs) except vitiligo or resolved childhood asthma/atopy.\n * Known human immunodeficiency virus (HIV) and/or active and acute Hepatitis B or C infections.\n * Not fully recovered from any effects of major surgery without significant detectable infection.\n * Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study.\n * Had chemotherapy, definitive radiation, or biological cancer therapy within 4 weeks (2 weeks for palliative radiation) before the first dose of study treatment, or has not recovered to Grade â‰¤1 or better from any AEs that were due to cancer therapeutics administered more than 4 weeks earlier.\n * Expected to require any other form of antineoplastic therapy while participating in this study.\n * On chronic systemic steroid therapy in excess of replacement doses (e.g., exceeding 10 mg/day of prednisone equivalent), or on any other form of immunosuppressive medication.\n * Regular user (including \"recreational use\") of any illicit drugs at the time of signing informed consent, or has a recent history (within the last year) of substance abuse (including alcohol), as determined by the treating investigator. Participants who use cannabis for medicinal purposes or to treat specific symptoms will not be excluded unless it is being abused in the opinion of the treating investigator.\n * Received a live-virus vaccine within 28 days before the first dose of study treatment.\n * Currently participating and receiving study treatment in a study of an investigational agent or has participated and received study treatment in a study of an investigational agent or has used an investigational device within 28 days before the first dose of study treatment.\n\nAdditional Exclusion Criteria for Participants in Arm 3:\n\n * Has received radiation therapy to the lung that is >30 Gray (Gy) within 6 months before the first dose of study treatment.\n * Is unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs), other than an aspirin dose â‰¤1.3 g per day, for a 5-day period (8-day period for long-acting agents, such as piroxicam).\n * Is unable or unwilling to take folic acid or vitamin B12 supplementation.",{"$nulls":4},"Actual","2018-01-11","Actual","Anticipated","2022-07-05","Anticipated","2019-11-01","2018-01-04","2018-01-04","2019-11-07","No",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No","Yes\nhttp://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf",{"$nulls":3},"Yes","No",{"$nulls":17},"MK-5890-001","Merck Protocol Number","Arms 1 and 2: Dose-limiting Toxicities (DLTs) Graded Using National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 or Later|Arms 1 and 2: Number of Participants with Adverse Events (AEs)|Arms 1 and 2: Number of Study Treatment Discontinuations Due to an Adverse Event (AE)","A DLT is defined as any of the following toxicities, if assessed by the investigator to be related to study treatment:\n\n * Grade 4 nonhematologic toxicity;\n * Grade 4 hematologic toxicity lasting â‰¥7 days, except thrombocytopenia;\n * Grade 4 thrombocytopenia;\n * Grade 3 thrombocytopenia associated with bleeding that requires a platelet transfusion;\n * Nonhematologic adverse event (AE) Grade â‰¥3 in severity, with exceptions;\n * Grade 3 or 4 nonhematologic laboratory abnormality if: clinically significant medical intervention is required or if abnormality leads to hospitalization, persists for >1 week or results in drug-induced liver injury with exceptions;\n * Grade 3 or Grade 4 febrile neutropenia;\n * Prolonged delay (>2 weeks) in initiating Cycle 2 due to treatment-related toxicity;\n * Treatment-related toxicity resulting in participant study treatment discontinuation during Cycle 1;\n * Missing >25% of the MK-5890 dose during Cycle 1 resulting from treatment-related AE;\n * Grade 5 toxicity.|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants in Arms 1 and 2 who experience at least one AE will be presented.|The number of participants in Arms 1 and 2 who discontinue study treatment due to an AE will be presented.","Cycle 1 (Up to 21 days)|Up to 27 months|Up to 24 months","All Arms: Area Under the Concentration-Time Curve (AUC) of MK-5890|All Arms: Minimum Serum Concentration (Cmin) of MK-5890|All Arms: Maximum Serum Concentration (Cmax) of MK-5890|Arms 1 and 2: Objective Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)|Arm 3: Dose-limiting Toxicities (DLTs) Graded Using National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 or Later|Arm 3: Number of Participants with Adverse Events (AEs)|Arm 3: Number of Study Treatment Discontinuations Due to an Adverse Event (AE)","Blood samples will be obtained at designated time points for the assessment of MK-5890 AUC: Cycles 1-4: Day 1: Predose, (end of pembrolizumab infusion for participants receiving pembrolizumab), end of MK-5890 infusion, 2 hours post start of MK-5890 infusion, Days 2, 3, 5, 8 & 15: Once daily; Cycles 5, 6 & every 4 cycles thereafter: Day1: Predose; 30 days post last dose. Each cycle is 21 days. (Up to 25 months)|Blood samples will be obtained at designated time points for the assessment of MK-5890 Cmin: Cycles 1-4: Day 1: Predose, (end of pembrolizumab infusion for participants receiving pembrolizumab), end of MK-5890 infusion, 2 hours post start of MK-5890 infusion, Days 2, 3, 5, 8 & 15: Once daily; Cycles 5, 6 & every 4 cycles thereafter: Day1: Predose; 30 days post last dose. Each cycle is 21 days. (Up to 25 months)|Blood samples will be obtained at designated time points for the assessment of MK-5890 Cmax: Cycles 1-4: Day 1: Predose, (end of pembrolizumab infusion for participants receiving pembrolizumab), end of MK-5890 infusion, 2 hours post start of MK-5890 infusion, Days 2, 3, 5, 8 & 15: Once daily; Cycles 5, 6 & every 4 cycles thereafter: Day1: Predose; 30 days post last dose. Each cycle is 21 days. (Up to 25 months)|The ORR is defined as the percentage of participants who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. The ORR of MK-5890 when used as monotherapy and in combination with pembrolizumab (Arms 1 and 2) as assessed by the investigator will be presented.|A DLT is defined as any of the following toxicities, if assessed by the investigator to be related to study treatment:\n\n * Grade 4 nonhematologic toxicity;\n * Grade 4 hematologic toxicity lasting â‰¥7 days, except thrombocytopenia;\n * Grade 4 thrombocytopenia;\n * Grade 3 thrombocytopenia associated with bleeding that requires a platelet transfusion;\n * Nonhematologic adverse event (AE) Grade â‰¥3 in severity, with exceptions;\n * Grade 3 or 4 nonhematologic laboratory abnormality if: clinically significant medical intervention is required or if abnormality leads to hospitalization, persists for >1 week or results in drug-induced liver injury with exceptions;\n * Grade 3 or Grade 4 febrile neutropenia;\n * Prolonged delay (>2 weeks) in initiating Cycle 2 due to treatment-related toxicity;\n * Treatment-related toxicity resulting in participant study treatment discontinuation during Cycle 1;\n * Missing >25% of the MK-5890 dose during Cycle 1 resulting from treatment-related AE;\n * Grade 5 toxicity.|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants in Arm 3 who experience at least one AE will be presented.|The number of participants in Arm 3 who discontinue study treatment due to an AE will be presented.","At designated time points (Up to 25 months)|Up to 24 months|Cycle 1 (Up to 21 days)|Up to 27 months","Trialsites@merck.com","Toll Free Number","1-888-577-8839","Jerusalem, Israel, 9112001|Amsterdam, Netherlands, 1066 Cx|Barcelona, Spain, 08916|Mobile, Alabama, United States, 36604|Sarasota, Florida, United States, 34232|Germantown, Tennessee, United States, 38138","Alabama|Florida|Tennessee","Israel|Netherlands|Spain|United States","Hadassah Ein Kerem Medical Center ( Site 0010)|Antoni Van Leeuwenhoek Ziekenhuis ( Site 0003)|Instituto Catalan De Oncologia - Ico ( Site 0044)|University Of South Alabama, Mitchell Cancer Institute ( Site 0020)|Florida Cancer Specialists ( Site 0002)|The West Clinic, P.C. ( Site 0021)",{"$nulls":3},"Medical Director","2019-11-07","2020-05-25T16:36:19.074","2020-05-26T17:10:42.972","NCT03396445"]
["5ecbf403fe30261b1a048223","NCT03396445","2019-11-14","Merck","MRK","Recruiting","Safety and Pharmacokinetics Study of MK-5890 as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Adults With Advanced Solid Tumors (MK-5890-001)","Pembrolizumab|Pemetrexed|Carboplatin","PD-1 Inhibitor|DHFR Antagonist|TS Inhibitor|DNA Synthesis Inhibitor|Mitosis Inhibitor|Tubulin Inhibitor","Unknown",null,"Unknown",null,"Phase 1",3,162,"Anticipated","2018-02-18","2022-07-05","DLT","Dose Limiting Toxicity",{"$nulls":3},"The purpose of this study is to assess the safety and pharmacokinetics of MK-5890 when administered alone and in combination with pembrolizumab (MK-3475) in adults with advanced solid tumors. The initial course of MK-5890 monotherapy or MK-5890 plus pembrolizumab combination therapy will be for up to 35 administrations (approximately 2 years). The safety and pharmacokinetics of MK-5890 when administered with pembrolizumab, pemetrexed and carboplatin will also be assessed in adults with non-squamous non-small cell lung cancer (NSCLC).","Participants receiving MK-5890 monotherapy who experience disease progression may be eligible to switch to receiving MK-5890 plus pembrolizumab combination therapy for up to 35 cycles (approximately 2 years) at the discretion of the Investigator and approval of the Sponsor.","A Phase 1 Study of MK-5890 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors","5890-001","Pharmacokinetics\nSolid Tumor","Oncology Solid Tumor Unspecified|Oncology Unspecified|Other","Oncology Solid Tumor|Oncology Unspecified|Other","Oncology|Other","Experimental","Arm 1: MK-5890|Arm 2: MK-5890 + Pembrolizumab|Arm 3: MK-5890 + Pembrolizumab + Pemetrexed + Carboplatin","Participants receive escalating doses of MK-5890 via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years).|Participants receive escalating doses of MK-5890 via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years).|Participants receive MK-5890 at the selected dose via IV infusion PLUS pembrolizumab 200 mg via IV infusion PLUS pemetrexed 500 mg/m^2 via IV infusion PLUS carboplatin Area Under the Curve (AUC) 5 mg/mL/min via IV infusion, all given on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years).","Drug|Biological","MK-5890|Pembrolizumab|Pemetrexed|Carboplatin","IV infusion","MK-3475|ALIMTAÂ®|PARAPLATINÂ®","Arm 1: MK-5890|Arm 2: MK-5890 + Pembrolizumab|Arm 3: MK-5890 + Pembrolizumab + Pemetrexed + Carboplatin","\n\n * Arms 1 & 2: Histologically or cytologically confirmed advanced/metastatic solid tumor by pathology report and has received or been intolerant to all treatment known to confer clinical benefit.\n * Arm 3: Histologically or cytologically confirmed diagnosis of stage IV (M1a or M1b per current American Joint Committee on Cancer criteria) non-squamous NSCLC.\n * Measureable disease by RECIST 1.1. as assessed by the local site investigator/radiologist. Target lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.\n * Adequate organ function.\n * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n * Male participants must agree to use adequate contraception during the treatment period and for at least 120 days after the last dose of MK-5890 or pembrolizumab OR 180 days after the last dose of chemotherapeutic agents and refrain from donating sperm during this period.\n * Female participants must not be pregnant or breast feeding and agree to follow use adequate contraception during the treatment period and for at least 120 days after the last dose of MK-5890 or pembrolizumab OR 180 days after the last dose of chemotherapeutic agents.\n * Submit an evaluable baseline tumor sample for analysis (either a newly obtained or archival tumor sample).\n\n","\n\n * History of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years.\n * Clinically active central nervous system metastases and/or carcinomatous meningitis.\n * Has had a severe hypersensitivity reaction to treatment with a monoclonal antibody (mAb) and/or other components of the study treatment.\n * Active infection requiring systemic treatment.\n * History of interstitial lung disease.\n * History of (noninfectious) pneumonitis that required steroids or current pneumonitis.\n * Symptomatic ascites or pleural effusion.\n * Previously had a stem cell or bone marrow transplant.\n * Previously had a solid organ transplant.\n * Active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs) except vitiligo or resolved childhood asthma/atopy.\n * Known human immunodeficiency virus (HIV) and/or active and acute Hepatitis B or C infections.\n * Not fully recovered from any effects of major surgery without significant detectable infection.\n * Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study.\n * Had chemotherapy, definitive radiation, or biological cancer therapy within 4 weeks (2 weeks for palliative radiation) before the first dose of study treatment, or has not recovered to Grade â‰¤1 or better from any AEs that were due to cancer therapeutics administered more than 4 weeks earlier.\n * Expected to require any other form of antineoplastic therapy while participating in this study.\n * On chronic systemic steroid therapy in excess of replacement doses (e.g., exceeding 10 mg/day of prednisone equivalent), or on any other form of immunosuppressive medication.\n * Regular user (including \"recreational use\") of any illicit drugs at the time of signing informed consent, or has a recent history (within the last year) of substance abuse (including alcohol), as determined by the treating investigator. Participants who use cannabis for medicinal purposes or to treat specific symptoms will not be excluded unless it is being abused in the opinion of the treating investigator.\n * Received a live-virus vaccine within 28 days before the first dose of study treatment.\n * Currently participating and receiving study treatment in a study of an investigational agent or has participated and received study treatment in a study of an investigational agent or has used an investigational device within 28 days before the first dose of study treatment.\n\nAdditional Exclusion Criteria for Participants in Arm 3:\n\n * Has received radiation therapy to the lung that is >30 Gray (Gy) within 6 months before the first dose of study treatment.\n * Is unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs), other than an aspirin dose â‰¤1.3 g per day, for a 5-day period (8-day period for long-acting agents, such as piroxicam).\n * Is unable or unwilling to take folic acid or vitamin B12 supplementation.",{"$nulls":4},"Actual","2018-01-11","Actual","Anticipated","2022-07-05","Anticipated","2019-11-01","2018-01-04","2018-01-04","2019-11-13","No",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No","Yes\nhttp://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf",{"$nulls":3},"Yes","No",{"$nulls":17},"MK-5890-001","Merck Protocol Number","Arms 1 and 2: Dose-limiting Toxicities (DLTs) Graded Using National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 or Later|Arms 1 and 2: Number of Participants with Adverse Events (AEs)|Arms 1 and 2: Number of Study Treatment Discontinuations Due to an Adverse Event (AE)","A DLT is defined as any of the following toxicities, if assessed by the investigator to be related to study treatment:\n\n * Grade 4 nonhematologic toxicity;\n * Grade 4 hematologic toxicity lasting â‰¥7 days, except thrombocytopenia;\n * Grade 4 thrombocytopenia;\n * Grade 3 thrombocytopenia associated with bleeding that requires a platelet transfusion;\n * Nonhematologic adverse event (AE) Grade â‰¥3 in severity, with exceptions;\n * Grade 3 or 4 nonhematologic laboratory abnormality if: clinically significant medical intervention is required or if abnormality leads to hospitalization, persists for >1 week or results in drug-induced liver injury with exceptions;\n * Grade 3 or Grade 4 febrile neutropenia;\n * Prolonged delay (>2 weeks) in initiating Cycle 2 due to treatment-related toxicity;\n * Treatment-related toxicity resulting in participant study treatment discontinuation during Cycle 1;\n * Missing >25% of the MK-5890 dose during Cycle 1 resulting from treatment-related AE;\n * Grade 5 toxicity.|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants in Arms 1 and 2 who experience at least one AE will be presented.|The number of participants in Arms 1 and 2 who discontinue study treatment due to an AE will be presented.","Cycle 1 (Up to 21 days)|Up to 27 months|Up to 24 months","All Arms: Area Under the Concentration-Time Curve (AUC) of MK-5890|All Arms: Minimum Serum Concentration (Cmin) of MK-5890|All Arms: Maximum Serum Concentration (Cmax) of MK-5890|Arms 1 and 2: Objective Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)|Arm 3: Dose-limiting Toxicities (DLTs) Graded Using National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 or Later|Arm 3: Number of Participants with Adverse Events (AEs)|Arm 3: Number of Study Treatment Discontinuations Due to an Adverse Event (AE)","Blood samples will be obtained at designated time points for the assessment of MK-5890 AUC: Cycles 1-4: Day 1: Predose, (end of pembrolizumab infusion for participants receiving pembrolizumab), end of MK-5890 infusion, 2 hours post start of MK-5890 infusion, Days 2, 3, 5, 8 & 15: Once daily; Cycles 5, 6 & every 4 cycles thereafter: Day1: Predose; 30 days post last dose. Each cycle is 21 days. (Up to 25 months)|Blood samples will be obtained at designated time points for the assessment of MK-5890 Cmin: Cycles 1-4: Day 1: Predose, (end of pembrolizumab infusion for participants receiving pembrolizumab), end of MK-5890 infusion, 2 hours post start of MK-5890 infusion, Days 2, 3, 5, 8 & 15: Once daily; Cycles 5, 6 & every 4 cycles thereafter: Day1: Predose; 30 days post last dose. Each cycle is 21 days. (Up to 25 months)|Blood samples will be obtained at designated time points for the assessment of MK-5890 Cmax: Cycles 1-4: Day 1: Predose, (end of pembrolizumab infusion for participants receiving pembrolizumab), end of MK-5890 infusion, 2 hours post start of MK-5890 infusion, Days 2, 3, 5, 8 & 15: Once daily; Cycles 5, 6 & every 4 cycles thereafter: Day1: Predose; 30 days post last dose. Each cycle is 21 days. (Up to 25 months)|The ORR is defined as the percentage of participants who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. The ORR of MK-5890 when used as monotherapy and in combination with pembrolizumab (Arms 1 and 2) as assessed by the investigator will be presented.|A DLT is defined as any of the following toxicities, if assessed by the investigator to be related to study treatment:\n\n * Grade 4 nonhematologic toxicity;\n * Grade 4 hematologic toxicity lasting â‰¥7 days, except thrombocytopenia;\n * Grade 4 thrombocytopenia;\n * Grade 3 thrombocytopenia associated with bleeding that requires a platelet transfusion;\n * Nonhematologic adverse event (AE) Grade â‰¥3 in severity, with exceptions;\n * Grade 3 or 4 nonhematologic laboratory abnormality if: clinically significant medical intervention is required or if abnormality leads to hospitalization, persists for >1 week or results in drug-induced liver injury with exceptions;\n * Grade 3 or Grade 4 febrile neutropenia;\n * Prolonged delay (>2 weeks) in initiating Cycle 2 due to treatment-related toxicity;\n * Treatment-related toxicity resulting in participant study treatment discontinuation during Cycle 1;\n * Missing >25% of the MK-5890 dose during Cycle 1 resulting from treatment-related AE;\n * Grade 5 toxicity.|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants in Arm 3 who experience at least one AE will be presented.|The number of participants in Arm 3 who discontinue study treatment due to an AE will be presented.","At designated time points (Up to 25 months)|Up to 24 months|Cycle 1 (Up to 21 days)|Up to 27 months","Trialsites@merck.com","Toll Free Number","1-888-577-8839","Jerusalem, Israel, 9112001|Amsterdam, Netherlands, 1066 Cx|Barcelona, Spain, 08916|Mobile, Alabama, United States, 36604|Sarasota, Florida, United States, 34232|Germantown, Tennessee, United States, 38138","Alabama|Florida|Tennessee","Israel|Netherlands|Spain|United States","Hadassah Ein Kerem Medical Center ( Site 0010)|Antoni Van Leeuwenhoek Ziekenhuis ( Site 0003)|Instituto Catalan De Oncologia - Ico ( Site 0044)|University Of South Alabama, Mitchell Cancer Institute ( Site 0020)|Florida Cancer Specialists ( Site 0002)|The West Clinic, P.C. ( Site 0021)",{"$nulls":3},"Medical Director","2019-11-13","2020-05-25T16:36:19.443","2020-05-26T17:10:42.972","NCT03396445"]
["5ecbf403e2561b1b11905d1f","NCT03396445","2019-12-12","Merck","MRK","Recruiting","Safety and Pharmacokinetics Study of MK-5890 as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Adults With Advanced Solid Tumors (MK-5890-001)","Pembrolizumab|Pemetrexed|Carboplatin","PD-1 Inhibitor|DHFR Antagonist|TS Inhibitor|DNA Synthesis Inhibitor|Mitosis Inhibitor|Tubulin Inhibitor","Unknown",null,"Unknown",null,"Phase 1",3,162,"Anticipated","2018-02-18","2022-07-05","DLT","Dose Limiting Toxicity",{"$nulls":3},"The purpose of this study is to assess the safety and pharmacokinetics of MK-5890 when administered alone and in combination with pembrolizumab (MK-3475) in adults with advanced solid tumors. The initial course of MK-5890 monotherapy or MK-5890 plus pembrolizumab combination therapy will be for up to 35 administrations (approximately 2 years). The safety and pharmacokinetics of MK-5890 when administered with pembrolizumab, pemetrexed and carboplatin will also be assessed in adults with non-squamous non-small cell lung cancer (NSCLC).","Participants receiving MK-5890 monotherapy who experience disease progression may be eligible to switch to receiving MK-5890 plus pembrolizumab combination therapy for up to 35 cycles (approximately 2 years) at the discretion of the Investigator and approval of the Sponsor.","A Phase 1 Study of MK-5890 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors","5890-001","Pharmacokinetics\nSolid Tumor","Oncology Solid Tumor Unspecified|Oncology Unspecified|Other","Oncology Solid Tumor|Oncology Unspecified|Other","Oncology|Other","Experimental","Arm 1: MK-5890|Arm 2: MK-5890 + Pembrolizumab|Arm 3: MK-5890 + Pembrolizumab + Pemetrexed + Carboplatin","Participants receive escalating doses of MK-5890 via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years).|Participants receive escalating doses of MK-5890 via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years).|Participants receive MK-5890 at the selected dose via IV infusion PLUS pembrolizumab 200 mg via IV infusion PLUS pemetrexed 500 mg/m^2 via IV infusion PLUS carboplatin Area Under the Curve (AUC) 5 mg/mL/min via IV infusion, all given on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years).","Drug|Biological","MK-5890|Pembrolizumab|Pemetrexed|Carboplatin","IV infusion","MK-3475|ALIMTAÂ®|PARAPLATINÂ®","Arm 1: MK-5890|Arm 2: MK-5890 + Pembrolizumab|Arm 3: MK-5890 + Pembrolizumab + Pemetrexed + Carboplatin","\n\n * Arms 1 & 2: Histologically or cytologically confirmed advanced/metastatic solid tumor by pathology report and has received or been intolerant to all treatment known to confer clinical benefit.\n * Arm 3: Histologically or cytologically confirmed diagnosis of stage IV (M1a or M1b per current American Joint Committee on Cancer criteria) non-squamous NSCLC.\n * Measureable disease by RECIST 1.1. as assessed by the local site investigator/radiologist. Target lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.\n * Adequate organ function.\n * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n * Male participants must agree to use adequate contraception during the treatment period and for at least 120 days after the last dose of MK-5890 or pembrolizumab OR 180 days after the last dose of chemotherapeutic agents and refrain from donating sperm during this period.\n * Female participants must not be pregnant or breast feeding and agree to follow use adequate contraception during the treatment period and for at least 120 days after the last dose of MK-5890 or pembrolizumab OR 180 days after the last dose of chemotherapeutic agents.\n * Submit an evaluable baseline tumor sample for analysis (either a newly obtained or archival tumor sample).\n\n","\n\n * History of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years.\n * Clinically active central nervous system metastases and/or carcinomatous meningitis.\n * Has had a severe hypersensitivity reaction to treatment with a monoclonal antibody (mAb) and/or other components of the study treatment.\n * Active infection requiring systemic treatment.\n * History of interstitial lung disease.\n * History of (noninfectious) pneumonitis that required steroids or current pneumonitis.\n * Symptomatic ascites or pleural effusion.\n * Previously had a stem cell or bone marrow transplant.\n * Previously had a solid organ transplant.\n * Active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs) except vitiligo or resolved childhood asthma/atopy.\n * Known human immunodeficiency virus (HIV) and/or active and acute Hepatitis B or C infections.\n * Not fully recovered from any effects of major surgery without significant detectable infection.\n * Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study.\n * Had chemotherapy, definitive radiation, or biological cancer therapy within 4 weeks (2 weeks for palliative radiation) before the first dose of study treatment, or has not recovered to Grade â‰¤1 or better from any AEs that were due to cancer therapeutics administered more than 4 weeks earlier.\n * Expected to require any other form of antineoplastic therapy while participating in this study.\n * On chronic systemic steroid therapy in excess of replacement doses (e.g., exceeding 10 mg/day of prednisone equivalent), or on any other form of immunosuppressive medication.\n * Regular user (including \"recreational use\") of any illicit drugs at the time of signing informed consent, or has a recent history (within the last year) of substance abuse (including alcohol), as determined by the treating investigator. Participants who use cannabis for medicinal purposes or to treat specific symptoms will not be excluded unless it is being abused in the opinion of the treating investigator.\n * Received a live-virus vaccine within 28 days before the first dose of study treatment.\n * Currently participating and receiving study treatment in a study of an investigational agent or has participated and received study treatment in a study of an investigational agent or has used an investigational device within 28 days before the first dose of study treatment.\n\nAdditional Exclusion Criteria for Participants in Arm 3:\n\n * Has received radiation therapy to the lung that is >30 Gray (Gy) within 6 months before the first dose of study treatment.\n * Is unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs), other than an aspirin dose â‰¤1.3 g per day, for a 5-day period (8-day period for long-acting agents, such as piroxicam).\n * Is unable or unwilling to take folic acid or vitamin B12 supplementation.",{"$nulls":4},"Actual","2018-01-11","Actual","Anticipated","2022-07-05","Anticipated","2019-12-01","2018-01-04","2018-01-04","2019-12-11","No",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No","Yes\nhttp://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf",{"$nulls":3},"Yes","No",{"$nulls":17},"MK-5890-001","Merck Protocol Number","Arms 1 and 2: Dose-limiting Toxicities (DLTs) Graded Using National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 or Later|Arms 1 and 2: Number of Participants with Adverse Events (AEs)|Arms 1 and 2: Number of Study Treatment Discontinuations Due to an Adverse Event (AE)","A DLT is defined as any of the following toxicities, if assessed by the investigator to be related to study treatment:\n\n * Grade 4 nonhematologic toxicity;\n * Grade 4 hematologic toxicity lasting â‰¥7 days, except thrombocytopenia;\n * Grade 4 thrombocytopenia;\n * Grade 3 thrombocytopenia associated with bleeding that requires a platelet transfusion;\n * Nonhematologic adverse event (AE) Grade â‰¥3 in severity, with exceptions;\n * Grade 3 or 4 nonhematologic laboratory abnormality if: clinically significant medical intervention is required or if abnormality leads to hospitalization, persists for >1 week or results in drug-induced liver injury with exceptions;\n * Grade 3 or Grade 4 febrile neutropenia;\n * Prolonged delay (>2 weeks) in initiating Cycle 2 due to treatment-related toxicity;\n * Treatment-related toxicity resulting in participant study treatment discontinuation during Cycle 1;\n * Missing >25% of the MK-5890 dose during Cycle 1 resulting from treatment-related AE;\n * Grade 5 toxicity.|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants in Arms 1 and 2 who experience at least one AE will be presented.|The number of participants in Arms 1 and 2 who discontinue study treatment due to an AE will be presented.","Cycle 1 (Up to 21 days)|Up to 27 months|Up to 24 months","All Arms: Area Under the Concentration-Time Curve (AUC) of MK-5890|All Arms: Minimum Serum Concentration (Cmin) of MK-5890|All Arms: Maximum Serum Concentration (Cmax) of MK-5890|Arms 1 and 2: Objective Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)|Arm 3: Dose-limiting Toxicities (DLTs) Graded Using National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 or Later|Arm 3: Number of Participants with Adverse Events (AEs)|Arm 3: Number of Study Treatment Discontinuations Due to an Adverse Event (AE)","Blood samples will be obtained at designated time points for the assessment of MK-5890 AUC: Cycles 1-4: Day 1: Predose, (end of pembrolizumab infusion for participants receiving pembrolizumab), end of MK-5890 infusion, 2 hours post start of MK-5890 infusion, Days 2, 3, 5, 8 & 15: Once daily; Cycles 5, 6 & every 4 cycles thereafter: Day1: Predose; 30 days post last dose. Each cycle is 21 days. (Up to 25 months)|Blood samples will be obtained at designated time points for the assessment of MK-5890 Cmin: Cycles 1-4: Day 1: Predose, (end of pembrolizumab infusion for participants receiving pembrolizumab), end of MK-5890 infusion, 2 hours post start of MK-5890 infusion, Days 2, 3, 5, 8 & 15: Once daily; Cycles 5, 6 & every 4 cycles thereafter: Day1: Predose; 30 days post last dose. Each cycle is 21 days. (Up to 25 months)|Blood samples will be obtained at designated time points for the assessment of MK-5890 Cmax: Cycles 1-4: Day 1: Predose, (end of pembrolizumab infusion for participants receiving pembrolizumab), end of MK-5890 infusion, 2 hours post start of MK-5890 infusion, Days 2, 3, 5, 8 & 15: Once daily; Cycles 5, 6 & every 4 cycles thereafter: Day1: Predose; 30 days post last dose. Each cycle is 21 days. (Up to 25 months)|The ORR is defined as the percentage of participants who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. The ORR of MK-5890 when used as monotherapy and in combination with pembrolizumab (Arms 1 and 2) as assessed by the investigator will be presented.|A DLT is defined as any of the following toxicities, if assessed by the investigator to be related to study treatment:\n\n * Grade 4 nonhematologic toxicity;\n * Grade 4 hematologic toxicity lasting â‰¥7 days, except thrombocytopenia;\n * Grade 4 thrombocytopenia;\n * Grade 3 thrombocytopenia associated with bleeding that requires a platelet transfusion;\n * Nonhematologic adverse event (AE) Grade â‰¥3 in severity, with exceptions;\n * Grade 3 or 4 nonhematologic laboratory abnormality if: clinically significant medical intervention is required or if abnormality leads to hospitalization, persists for >1 week or results in drug-induced liver injury with exceptions;\n * Grade 3 or Grade 4 febrile neutropenia;\n * Prolonged delay (>2 weeks) in initiating Cycle 2 due to treatment-related toxicity;\n * Treatment-related toxicity resulting in participant study treatment discontinuation during Cycle 1;\n * Missing >25% of the MK-5890 dose during Cycle 1 resulting from treatment-related AE;\n * Grade 5 toxicity.|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants in Arm 3 who experience at least one AE will be presented.|The number of participants in Arm 3 who discontinue study treatment due to an AE will be presented.","At designated time points (Up to 25 months)|Up to 24 months|Cycle 1 (Up to 21 days)|Up to 27 months","Trialsites@merck.com","Toll Free Number","1-888-577-8839","Jerusalem, Israel, 9112001|Amsterdam, Netherlands, 1066 Cx|Barcelona, Spain, 08916|Mobile, Alabama, United States, 36604|Sarasota, Florida, United States, 34232|Germantown, Tennessee, United States, 38138","Alabama|Florida|Tennessee","Israel|Netherlands|Spain|United States","Hadassah Ein Kerem Medical Center ( Site 0010)|Antoni Van Leeuwenhoek Ziekenhuis ( Site 0003)|Instituto Catalan De Oncologia - Ico ( Site 0044)|University Of South Alabama, Mitchell Cancer Institute ( Site 0020)|Florida Cancer Specialists ( Site 0002)|The West Clinic, P.C. ( Site 0021)",{"$nulls":3},"Medical Director","2019-12-11","2020-05-25T16:36:19.558","2020-05-26T17:10:42.972","NCT03396445"]
["5ecbf403feab101b15530853","NCT03396445","2020-03-09","Merck","MRK","Recruiting","Safety and Pharmacokinetics Study of MK-5890 as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Adults With Advanced Solid Tumors (MK-5890-001)","Pembrolizumab|Pemetrexed|Carboplatin","PD-1 Inhibitor|DHFR Antagonist|TS Inhibitor|DNA Synthesis Inhibitor|Mitosis Inhibitor|Tubulin Inhibitor","Unknown",null,"Unknown",null,"Phase 1",3,162,"Anticipated","2018-02-18","2022-10-06","DLT","Dose Limiting Toxicity",{"$nulls":3},"The purpose of this study is to assess the safety and pharmacokinetics of MK-5890 when administered alone and in combination with pembrolizumab (MK-3475) in adults with advanced solid tumors. The initial course of MK-5890 monotherapy or MK-5890 plus pembrolizumab combination therapy will be for up to 35 administrations (approximately 2 years). The safety and pharmacokinetics of MK-5890 when administered with pembrolizumab, pemetrexed and carboplatin will also be assessed in adults with non-squamous non-small cell lung cancer (NSCLC).","Participants receiving MK-5890 monotherapy who experience disease progression may be eligible to switch to receiving MK-5890 plus pembrolizumab combination therapy for up to 35 cycles (approximately 2 years) at the discretion of the Investigator and approval of the Sponsor.","A Phase 1 Study of MK-5890 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors","5890-001","Pharmacokinetics\nSolid Tumor","Oncology Solid Tumor Unspecified|Oncology Unspecified|Other","Oncology Solid Tumor|Oncology Unspecified|Other","Oncology|Other","Experimental","Arm 1: MK-5890|Arm 2: MK-5890 + Pembrolizumab|Arm 3: MK-5890 + Pembrolizumab + Pemetrexed + Carboplatin","Participants receive escalating doses of MK-5890 via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years).|Participants receive escalating doses of MK-5890 via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years).|Participants receive MK-5890 at the selected dose via IV infusion PLUS pembrolizumab 200 mg via IV infusion PLUS pemetrexed 500 mg/m^2 via IV infusion PLUS carboplatin Area Under the Curve (AUC) 5 mg/mL/min via IV infusion, all given on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years).","Drug|Biological","MK-5890|Pembrolizumab|Pemetrexed|Carboplatin","IV infusion","MK-3475|ALIMTAÂ®|PARAPLATINÂ®","Arm 1: MK-5890|Arm 2: MK-5890 + Pembrolizumab|Arm 3: MK-5890 + Pembrolizumab + Pemetrexed + Carboplatin","\n\n * Arms 1 & 2: Histologically or cytologically confirmed advanced/metastatic solid tumor by pathology report and has received or been intolerant to all treatment known to confer clinical benefit.\n * Arm 3: Histologically or cytologically confirmed diagnosis of stage IV (M1a or M1b per current American Joint Committee on Cancer criteria) non-squamous NSCLC.\n * Measureable disease by RECIST 1.1. as assessed by the local site investigator/radiologist. Target lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.\n * Adequate organ function.\n * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n * Male participants must agree to use adequate contraception during the treatment period and for at least 120 days after the last dose of MK-5890 or pembrolizumab OR 180 days after the last dose of chemotherapeutic agents and refrain from donating sperm during this period.\n * Female participants must not be pregnant or breast feeding and agree to follow use adequate contraception during the treatment period and for at least 120 days after the last dose of MK-5890 or pembrolizumab OR 180 days after the last dose of chemotherapeutic agents.\n * Submit an evaluable baseline tumor sample for analysis (either a newly obtained or archival tumor sample).\n\n","\n\n * History of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years.\n * Clinically active central nervous system metastases and/or carcinomatous meningitis.\n * Has had a severe hypersensitivity reaction to treatment with a monoclonal antibody (mAb) and/or other components of the study treatment.\n * Active infection requiring systemic treatment.\n * History of interstitial lung disease.\n * History of (noninfectious) pneumonitis that required steroids or current pneumonitis.\n * Symptomatic ascites or pleural effusion.\n * Previously had a stem cell or bone marrow transplant.\n * Previously had a solid organ transplant.\n * Active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs) except vitiligo or resolved childhood asthma/atopy.\n * Known human immunodeficiency virus (HIV) and/or active and acute Hepatitis B or C infections.\n * Not fully recovered from any effects of major surgery without significant detectable infection.\n * Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study.\n * Had chemotherapy, definitive radiation, or biological cancer therapy within 4 weeks (2 weeks for palliative radiation) before the first dose of study treatment, or has not recovered to Grade â‰¤1 or better from any AEs that were due to cancer therapeutics administered more than 4 weeks earlier.\n * Expected to require any other form of antineoplastic therapy while participating in this study.\n * On chronic systemic steroid therapy in excess of replacement doses (e.g., exceeding 10 mg/day of prednisone equivalent), or on any other form of immunosuppressive medication.\n * Regular user (including \"recreational use\") of any illicit drugs at the time of signing informed consent, or has a recent history (within the last year) of substance abuse (including alcohol), as determined by the treating investigator. Participants who use cannabis for medicinal purposes or to treat specific symptoms will not be excluded unless it is being abused in the opinion of the treating investigator.\n * Received a live-virus vaccine within 28 days before the first dose of study treatment.\n * Currently participating and receiving study treatment in a study of an investigational agent or has participated and received study treatment in a study of an investigational agent or has used an investigational device within 28 days before the first dose of study treatment.\n\nAdditional Exclusion Criteria for Participants in Arm 3:\n\n * Has received radiation therapy to the lung that is >30 Gray (Gy) within 6 months before the first dose of study treatment.\n * Is unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs), other than an aspirin dose â‰¤1.3 g per day, for a 5-day period (8-day period for long-acting agents, such as piroxicam).\n * Is unable or unwilling to take folic acid or vitamin B12 supplementation.",{"$nulls":4},"Actual","2018-01-11","Actual","Anticipated","2022-10-06","Anticipated","2020-03-01","2018-01-04","2018-01-04","2020-03-06","No",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No","Yes\nhttp://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf",{"$nulls":3},"Yes","No",{"$nulls":17},"MK-5890-001","Merck Protocol Number","Arms 1 and 2: Dose-limiting Toxicities (DLTs) Graded Using National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 or Later|Arms 1 and 2: Number of Participants with Adverse Events (AEs)|Arms 1 and 2: Number of Study Treatment Discontinuations Due to an Adverse Event (AE)","A DLT is defined as any of the following toxicities, if assessed by the investigator to be related to study treatment:\n\n * Grade 4 nonhematologic toxicity;\n * Grade 4 hematologic toxicity lasting â‰¥7 days, except thrombocytopenia;\n * Grade 4 thrombocytopenia;\n * Grade 3 thrombocytopenia associated with bleeding that requires a platelet transfusion;\n * Nonhematologic adverse event (AE) Grade â‰¥3 in severity, with exceptions;\n * Grade 3 or 4 nonhematologic laboratory abnormality if: clinically significant medical intervention is required or if abnormality leads to hospitalization, persists for >1 week or results in drug-induced liver injury with exceptions;\n * Grade 3 or Grade 4 febrile neutropenia;\n * Prolonged delay (>2 weeks) in initiating Cycle 2 due to treatment-related toxicity;\n * Treatment-related toxicity resulting in participant study treatment discontinuation during Cycle 1;\n * Missing >25% of the MK-5890 dose during Cycle 1 resulting from treatment-related AE;\n * Grade 5 toxicity.|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants in Arms 1 and 2 who experience at least one AE will be presented.|The number of participants in Arms 1 and 2 who discontinue study treatment due to an AE will be presented.","Cycle 1 (Up to 21 days)|Up to 27 months|Up to 24 months","All Arms: Area Under the Concentration-Time Curve (AUC) of MK-5890|All Arms: Minimum Serum Concentration (Cmin) of MK-5890|All Arms: Maximum Serum Concentration (Cmax) of MK-5890|Arms 1 and 2: Objective Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)|Arm 3: Dose-limiting Toxicities (DLTs) Graded Using National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 or Later|Arm 3: Number of Participants with Adverse Events (AEs)|Arm 3: Number of Study Treatment Discontinuations Due to an Adverse Event (AE)","Blood samples will be obtained at designated time points for the assessment of MK-5890 AUC: Cycles 1-4: Day 1: Predose, (end of pembrolizumab infusion for participants receiving pembrolizumab), end of MK-5890 infusion, 2 hours post start of MK-5890 infusion, Days 2, 3, 5, 8 & 15: Once daily; Cycles 5, 6 & every 4 cycles thereafter: Day1: Predose; 30 days post last dose. Each cycle is 21 days. (Up to 25 months)|Blood samples will be obtained at designated time points for the assessment of MK-5890 Cmin: Cycles 1-4: Day 1: Predose, (end of pembrolizumab infusion for participants receiving pembrolizumab), end of MK-5890 infusion, 2 hours post start of MK-5890 infusion, Days 2, 3, 5, 8 & 15: Once daily; Cycles 5, 6 & every 4 cycles thereafter: Day1: Predose; 30 days post last dose. Each cycle is 21 days. (Up to 25 months)|Blood samples will be obtained at designated time points for the assessment of MK-5890 Cmax: Cycles 1-4: Day 1: Predose, (end of pembrolizumab infusion for participants receiving pembrolizumab), end of MK-5890 infusion, 2 hours post start of MK-5890 infusion, Days 2, 3, 5, 8 & 15: Once daily; Cycles 5, 6 & every 4 cycles thereafter: Day1: Predose; 30 days post last dose. Each cycle is 21 days. (Up to 25 months)|The ORR is defined as the percentage of participants who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. The ORR of MK-5890 when used as monotherapy and in combination with pembrolizumab (Arms 1 and 2) as assessed by the investigator will be presented.|A DLT is defined as any of the following toxicities, if assessed by the investigator to be related to study treatment:\n\n * Grade 4 nonhematologic toxicity;\n * Grade 4 hematologic toxicity lasting â‰¥7 days, except thrombocytopenia;\n * Grade 4 thrombocytopenia;\n * Grade 3 thrombocytopenia associated with bleeding that requires a platelet transfusion;\n * Nonhematologic adverse event (AE) Grade â‰¥3 in severity, with exceptions;\n * Grade 3 or 4 nonhematologic laboratory abnormality if: clinically significant medical intervention is required or if abnormality leads to hospitalization, persists for >1 week or results in drug-induced liver injury with exceptions;\n * Grade 3 or Grade 4 febrile neutropenia;\n * Prolonged delay (>2 weeks) in initiating Cycle 2 due to treatment-related toxicity;\n * Treatment-related toxicity resulting in participant study treatment discontinuation during Cycle 1;\n * Missing >25% of the MK-5890 dose during Cycle 1 resulting from treatment-related AE;\n * Grade 5 toxicity.|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants in Arm 3 who experience at least one AE will be presented.|The number of participants in Arm 3 who discontinue study treatment due to an AE will be presented.","At designated time points (Up to 25 months)|Up to 24 months|Cycle 1 (Up to 21 days)|Up to 27 months","Trialsites@merck.com","Toll Free Number","1-888-577-8839","Jerusalem, Israel, 9112001|Amsterdam, Netherlands, 1066 Cx|Barcelona, Spain, 08916|Mobile, Alabama, United States, 36604|Sarasota, Florida, United States, 34232|Germantown, Tennessee, United States, 38138","Alabama|Florida|Tennessee","Israel|Netherlands|Spain|United States","Hadassah Ein Kerem Medical Center ( Site 0010)|Antoni Van Leeuwenhoek Ziekenhuis ( Site 0003)|Instituto Catalan De Oncologia - Ico ( Site 0044)|University Of South Alabama, Mitchell Cancer Institute ( Site 0020)|Florida Cancer Specialists ( Site 0002)|The West Clinic, P.C. ( Site 0021)",{"$nulls":3},"Medical Director","2020-03-06","2020-05-25T16:36:19.377","2020-05-26T17:10:42.972","NCT03396445"]
["5ecbf403307e3d1b1f8d9cb5","NCT03396445","2020-03-27","Merck","MRK","Recruiting","Safety and Pharmacokinetics Study of MK-5890 as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Adults With Advanced Solid Tumors (MK-5890-001)","Pembrolizumab|Pemetrexed|Carboplatin","PD-1 Inhibitor|DHFR Antagonist|TS Inhibitor|DNA Synthesis Inhibitor|Mitosis Inhibitor|Tubulin Inhibitor","Unknown",null,"Unknown",null,"Phase 1",3,162,"Anticipated","2018-02-18","2022-10-06","DLT","Dose Limiting Toxicity",{"$nulls":3},"The purpose of this study is to assess the safety and pharmacokinetics of MK-5890 when administered alone and in combination with pembrolizumab (MK-3475) in adults with advanced solid tumors. The initial course of MK-5890 monotherapy or MK-5890 plus pembrolizumab combination therapy will be for up to 35 administrations (approximately 2 years). The safety and pharmacokinetics of MK-5890 when administered with pembrolizumab, pemetrexed and carboplatin will also be assessed in adults with non-squamous non-small cell lung cancer (NSCLC).","Participants receiving MK-5890 monotherapy who experience disease progression may be eligible to switch to receiving MK-5890 plus pembrolizumab combination therapy for up to 35 cycles (approximately 2 years) at the discretion of the Investigator and approval of the Sponsor.","A Phase 1 Study of MK-5890 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors","5890-001","Pharmacokinetics\nSolid Tumor","Oncology Solid Tumor Unspecified|Oncology Unspecified|Other","Oncology Solid Tumor|Oncology Unspecified|Other","Oncology|Other","Experimental","Arm 1: MK-5890|Arm 2: MK-5890 + Pembrolizumab|Arm 3: MK-5890 + Pembrolizumab + Pemetrexed + Carboplatin","Participants receive escalating doses of MK-5890 via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years).|Participants receive escalating doses of MK-5890 via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years).|Participants receive MK-5890 at the selected dose via IV infusion PLUS pembrolizumab 200 mg via IV infusion PLUS pemetrexed 500 mg/m^2 via IV infusion PLUS carboplatin Area Under the Curve (AUC) 5 mg/mL/min via IV infusion, all given on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years).","Drug|Biological","MK-5890|Pembrolizumab|Pemetrexed|Carboplatin","IV infusion","MK-3475|ALIMTAÂ®|PARAPLATINÂ®","Arm 1: MK-5890|Arm 2: MK-5890 + Pembrolizumab|Arm 3: MK-5890 + Pembrolizumab + Pemetrexed + Carboplatin","\n\n * Arms 1 & 2: Histologically or cytologically confirmed advanced/metastatic solid tumor by pathology report and has received or been intolerant to all treatment known to confer clinical benefit.\n * Arm 3: Histologically or cytologically confirmed diagnosis of stage IV (M1a or M1b per current American Joint Committee on Cancer criteria) non-squamous NSCLC.\n * Measureable disease by RECIST 1.1. as assessed by the local site investigator/radiologist. Target lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.\n * Adequate organ function.\n * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n * Male participants must agree to use adequate contraception during the treatment period and for at least 120 days after the last dose of MK-5890 or pembrolizumab OR 180 days after the last dose of chemotherapeutic agents and refrain from donating sperm during this period.\n * Female participants must not be pregnant or breast feeding and agree to follow use adequate contraception during the treatment period and for at least 120 days after the last dose of MK-5890 or pembrolizumab OR 180 days after the last dose of chemotherapeutic agents.\n * Submit an evaluable baseline tumor sample for analysis (either a newly obtained or archival tumor sample).\n\n","\n\n * History of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years.\n * Clinically active central nervous system metastases and/or carcinomatous meningitis.\n * Has had a severe hypersensitivity reaction to treatment with a monoclonal antibody (mAb) and/or other components of the study treatment.\n * Active infection requiring systemic treatment.\n * History of interstitial lung disease.\n * History of (noninfectious) pneumonitis that required steroids or current pneumonitis.\n * Symptomatic ascites or pleural effusion.\n * Previously had a stem cell or bone marrow transplant.\n * Previously had a solid organ transplant.\n * Active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs) except vitiligo or resolved childhood asthma/atopy.\n * Known human immunodeficiency virus (HIV) and/or active and acute Hepatitis B or C infections.\n * Not fully recovered from any effects of major surgery without significant detectable infection.\n * Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study.\n * Had chemotherapy, definitive radiation, or biological cancer therapy within 4 weeks (2 weeks for palliative radiation) before the first dose of study treatment, or has not recovered to Grade â‰¤1 or better from any AEs that were due to cancer therapeutics administered more than 4 weeks earlier.\n * Expected to require any other form of antineoplastic therapy while participating in this study.\n * On chronic systemic steroid therapy in excess of replacement doses (e.g., exceeding 10 mg/day of prednisone equivalent), or on any other form of immunosuppressive medication.\n * Regular user (including \"recreational use\") of any illicit drugs at the time of signing informed consent, or has a recent history (within the last year) of substance abuse (including alcohol), as determined by the treating investigator. Participants who use cannabis for medicinal purposes or to treat specific symptoms will not be excluded unless it is being abused in the opinion of the treating investigator.\n * Received a live-virus vaccine within 28 days before the first dose of study treatment.\n * Currently participating and receiving study treatment in a study of an investigational agent or has participated and received study treatment in a study of an investigational agent or has used an investigational device within 28 days before the first dose of study treatment.\n\nAdditional Exclusion Criteria for Participants in Arm 3:\n\n * Has received radiation therapy to the lung that is >30 Gray (Gy) within 6 months before the first dose of study treatment.\n * Is unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs), other than an aspirin dose â‰¤1.3 g per day, for a 5-day period (8-day period for long-acting agents, such as piroxicam).\n * Is unable or unwilling to take folic acid or vitamin B12 supplementation.",{"$nulls":4},"Actual","2018-01-11","Actual","Anticipated","2022-10-06","Anticipated","2020-03-01","2018-01-04","2018-01-04","2020-03-26","No",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No","Yes\nhttp://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf",{"$nulls":3},"Yes","No",{"$nulls":17},"MK-5890-001","Merck Protocol Number","Arms 1 and 2: Dose-limiting Toxicities (DLTs) Graded Using National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 or Later|Arms 1 and 2: Number of Participants with Adverse Events (AEs)|Arms 1 and 2: Number of Study Treatment Discontinuations Due to an Adverse Event (AE)","A DLT is defined as any of the following toxicities, if assessed by the investigator to be related to study treatment:\n\n * Grade 4 nonhematologic toxicity;\n * Grade 4 hematologic toxicity lasting â‰¥7 days, except thrombocytopenia;\n * Grade 4 thrombocytopenia;\n * Grade 3 thrombocytopenia associated with bleeding that requires a platelet transfusion;\n * Nonhematologic adverse event (AE) Grade â‰¥3 in severity, with exceptions;\n * Grade 3 or 4 nonhematologic laboratory abnormality if: clinically significant medical intervention is required or if abnormality leads to hospitalization, persists for >1 week or results in drug-induced liver injury with exceptions;\n * Grade 3 or Grade 4 febrile neutropenia;\n * Prolonged delay (>2 weeks) in initiating Cycle 2 due to treatment-related toxicity;\n * Treatment-related toxicity resulting in participant study treatment discontinuation during Cycle 1;\n * Missing >25% of the MK-5890 dose during Cycle 1 resulting from treatment-related AE;\n * Grade 5 toxicity.|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants in Arms 1 and 2 who experience at least one AE will be presented.|The number of participants in Arms 1 and 2 who discontinue study treatment due to an AE will be presented.","Cycle 1 (Up to 21 days)|Up to 27 months|Up to 24 months","All Arms: Area Under the Concentration-Time Curve (AUC) of MK-5890|All Arms: Minimum Serum Concentration (Cmin) of MK-5890|All Arms: Maximum Serum Concentration (Cmax) of MK-5890|Arms 1 and 2: Objective Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)|Arm 3: Dose-limiting Toxicities (DLTs) Graded Using National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 or Later|Arm 3: Number of Participants with Adverse Events (AEs)|Arm 3: Number of Study Treatment Discontinuations Due to an Adverse Event (AE)","Blood samples will be obtained at designated time points for the assessment of MK-5890 AUC: Cycles 1-4: Day 1: Predose, (end of pembrolizumab infusion for participants receiving pembrolizumab), end of MK-5890 infusion, 2 hours post start of MK-5890 infusion, Days 2, 3, 5, 8 & 15: Once daily; Cycles 5, 6 & every 4 cycles thereafter: Day1: Predose; 30 days post last dose. Each cycle is 21 days. (Up to 25 months)|Blood samples will be obtained at designated time points for the assessment of MK-5890 Cmin: Cycles 1-4: Day 1: Predose, (end of pembrolizumab infusion for participants receiving pembrolizumab), end of MK-5890 infusion, 2 hours post start of MK-5890 infusion, Days 2, 3, 5, 8 & 15: Once daily; Cycles 5, 6 & every 4 cycles thereafter: Day1: Predose; 30 days post last dose. Each cycle is 21 days. (Up to 25 months)|Blood samples will be obtained at designated time points for the assessment of MK-5890 Cmax: Cycles 1-4: Day 1: Predose, (end of pembrolizumab infusion for participants receiving pembrolizumab), end of MK-5890 infusion, 2 hours post start of MK-5890 infusion, Days 2, 3, 5, 8 & 15: Once daily; Cycles 5, 6 & every 4 cycles thereafter: Day1: Predose; 30 days post last dose. Each cycle is 21 days. (Up to 25 months)|The ORR is defined as the percentage of participants who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. The ORR of MK-5890 when used as monotherapy and in combination with pembrolizumab (Arms 1 and 2) as assessed by the investigator will be presented.|A DLT is defined as any of the following toxicities, if assessed by the investigator to be related to study treatment:\n\n * Grade 4 nonhematologic toxicity;\n * Grade 4 hematologic toxicity lasting â‰¥7 days, except thrombocytopenia;\n * Grade 4 thrombocytopenia;\n * Grade 3 thrombocytopenia associated with bleeding that requires a platelet transfusion;\n * Nonhematologic adverse event (AE) Grade â‰¥3 in severity, with exceptions;\n * Grade 3 or 4 nonhematologic laboratory abnormality if: clinically significant medical intervention is required or if abnormality leads to hospitalization, persists for >1 week or results in drug-induced liver injury with exceptions;\n * Grade 3 or Grade 4 febrile neutropenia;\n * Prolonged delay (>2 weeks) in initiating Cycle 2 due to treatment-related toxicity;\n * Treatment-related toxicity resulting in participant study treatment discontinuation during Cycle 1;\n * Missing >25% of the MK-5890 dose during Cycle 1 resulting from treatment-related AE;\n * Grade 5 toxicity.|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants in Arm 3 who experience at least one AE will be presented.|The number of participants in Arm 3 who discontinue study treatment due to an AE will be presented.","At designated time points (Up to 25 months)|Up to 24 months|Cycle 1 (Up to 21 days)|Up to 27 months","Trialsites@merck.com","Toll Free Number","1-888-577-8839","Ramat Gan, Israel, 5265601|Jerusalem, Yerushalayim, Israel, 9112001|Amsterdam, Netherlands, 1066 Cx|Barcelona, Spain, 08916|Mobile, Alabama, United States, 36604|Sarasota, Florida, United States, 34232|Germantown, Tennessee, United States, 38138","Alabama|Florida|Tennessee","Israel|Netherlands|Spain|United States","The Chaim Sheba Medical Center - Oncology Institute ( Site 0001)|Yerushalayim Hadassah Ein Kerem Medical Center ( Site 0010)|Antoni Van Leeuwenhoek Ziekenhuis ( Site 0003)|Instituto Catalan De Oncologia - Ico ( Site 0044)|University Of South Alabama, Mitchell Cancer Institute ( Site 0020)|Florida Cancer Specialists ( Site 0002)|The West Clinic, P.C. ( Site 0021)",{"$nulls":3},"Medical Director","2020-03-26","2020-05-25T16:36:19.939","2020-05-26T17:10:42.972","NCT03396445"]
["5ecbf403307e3d1b1f8d9cb4","NCT03396445","2020-04-10","Merck","MRK","Recruiting","Safety and Pharmacokinetics Study of MK-5890 as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Adults With Advanced Solid Tumors (MK-5890-001)","Pembrolizumab|Pemetrexed|Carboplatin","PD-1 Inhibitor|DHFR Antagonist|TS Inhibitor|DNA Synthesis Inhibitor|Mitosis Inhibitor|Tubulin Inhibitor","Unknown",null,"Unknown",null,"Phase 1",3,162,"Anticipated","2018-02-18","2022-10-06","DLT","Dose Limiting Toxicity",{"$nulls":3},"The purpose of this study is to assess the safety and pharmacokinetics of MK-5890 when administered alone and in combination with pembrolizumab (MK-3475) in adults with advanced solid tumors. The initial course of MK-5890 monotherapy or MK-5890 plus pembrolizumab combination therapy will be for up to 35 administrations (approximately 2 years). The safety and pharmacokinetics of MK-5890 when administered with pembrolizumab, pemetrexed and carboplatin will also be assessed in adults with non-squamous non-small cell lung cancer (NSCLC).","Participants receiving MK-5890 monotherapy who experience disease progression may be eligible to switch to receiving MK-5890 plus pembrolizumab combination therapy for up to 35 cycles (approximately 2 years) at the discretion of the Investigator and approval of the Sponsor.","A Phase 1 Study of MK-5890 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors","5890-001","Pharmacokinetics\nSolid Tumor","Oncology Solid Tumor Unspecified|Oncology Unspecified|Other","Oncology Solid Tumor|Oncology Unspecified|Other","Oncology|Other","Experimental","Arm 1: MK-5890|Arm 2: MK-5890 + Pembrolizumab|Arm 3: MK-5890 + Pembrolizumab + Pemetrexed + Carboplatin","Participants receive escalating doses of MK-5890 via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years).|Participants receive escalating doses of MK-5890 via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years).|Participants receive MK-5890 at the selected dose via IV infusion PLUS pembrolizumab 200 mg via IV infusion PLUS pemetrexed 500 mg/m^2 via IV infusion PLUS carboplatin Area Under the Curve (AUC) 5 mg/mL/min via IV infusion, all given on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years).","Drug|Biological","MK-5890|Pembrolizumab|Pemetrexed|Carboplatin","IV infusion","MK-3475|ALIMTAÂ®|PARAPLATINÂ®","Arm 1: MK-5890|Arm 2: MK-5890 + Pembrolizumab|Arm 3: MK-5890 + Pembrolizumab + Pemetrexed + Carboplatin","\n\n * Arms 1 & 2: Histologically or cytologically confirmed advanced/metastatic solid tumor by pathology report and has received or been intolerant to all treatment known to confer clinical benefit.\n * Arm 3: Histologically or cytologically confirmed diagnosis of stage IV (M1a or M1b per current American Joint Committee on Cancer criteria) non-squamous NSCLC.\n * Measureable disease by RECIST 1.1. as assessed by the local site investigator/radiologist. Target lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.\n * Adequate organ function.\n * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n * Male participants must agree to use adequate contraception during the treatment period and for at least 120 days after the last dose of MK-5890 or pembrolizumab OR 180 days after the last dose of chemotherapeutic agents and refrain from donating sperm during this period.\n * Female participants must not be pregnant or breast feeding and agree to follow use adequate contraception during the treatment period and for at least 120 days after the last dose of MK-5890 or pembrolizumab OR 180 days after the last dose of chemotherapeutic agents.\n * Submit an evaluable baseline tumor sample for analysis (either a newly obtained or archival tumor sample).\n\n","\n\n * History of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years.\n * Clinically active central nervous system metastases and/or carcinomatous meningitis.\n * Has had a severe hypersensitivity reaction to treatment with a monoclonal antibody (mAb) and/or other components of the study treatment.\n * Active infection requiring systemic treatment.\n * History of interstitial lung disease.\n * History of (noninfectious) pneumonitis that required steroids or current pneumonitis.\n * Symptomatic ascites or pleural effusion.\n * Previously had a stem cell or bone marrow transplant.\n * Previously had a solid organ transplant.\n * Active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs) except vitiligo or resolved childhood asthma/atopy.\n * Known human immunodeficiency virus (HIV) and/or active and acute Hepatitis B or C infections.\n * Not fully recovered from any effects of major surgery without significant detectable infection.\n * Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study.\n * Had chemotherapy, definitive radiation, or biological cancer therapy within 4 weeks (2 weeks for palliative radiation) before the first dose of study treatment, or has not recovered to Grade â‰¤1 or better from any AEs that were due to cancer therapeutics administered more than 4 weeks earlier.\n * Expected to require any other form of antineoplastic therapy while participating in this study.\n * On chronic systemic steroid therapy in excess of replacement doses (e.g., exceeding 10 mg/day of prednisone equivalent), or on any other form of immunosuppressive medication.\n * Regular user (including \"recreational use\") of any illicit drugs at the time of signing informed consent, or has a recent history (within the last year) of substance abuse (including alcohol), as determined by the treating investigator. Participants who use cannabis for medicinal purposes or to treat specific symptoms will not be excluded unless it is being abused in the opinion of the treating investigator.\n * Received a live-virus vaccine within 28 days before the first dose of study treatment.\n * Currently participating and receiving study treatment in a study of an investigational agent or has participated and received study treatment in a study of an investigational agent or has used an investigational device within 28 days before the first dose of study treatment.\n\nAdditional Exclusion Criteria for Participants in Arm 3:\n\n * Has received radiation therapy to the lung that is >30 Gray (Gy) within 6 months before the first dose of study treatment.\n * Is unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs), other than an aspirin dose â‰¤1.3 g per day, for a 5-day period (8-day period for long-acting agents, such as piroxicam).\n * Is unable or unwilling to take folic acid or vitamin B12 supplementation.",{"$nulls":4},"Actual","2018-01-11","Actual","Anticipated","2022-10-06","Anticipated","2020-04-01","2018-01-04","2018-01-04","2020-04-09","No",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No","Yes\nhttp://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf",{"$nulls":3},"Yes","No",{"$nulls":17},"MK-5890-001","Merck Protocol Number","Arms 1 and 2: Dose-limiting Toxicities (DLTs) Graded Using National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 or Later|Arms 1 and 2: Number of Participants with Adverse Events (AEs)|Arms 1 and 2: Number of Study Treatment Discontinuations Due to an Adverse Event (AE)","A DLT is defined as any of the following toxicities, if assessed by the investigator to be related to study treatment:\n\n * Grade 4 nonhematologic toxicity;\n * Grade 4 hematologic toxicity lasting â‰¥7 days, except thrombocytopenia;\n * Grade 4 thrombocytopenia;\n * Grade 3 thrombocytopenia associated with bleeding that requires a platelet transfusion;\n * Nonhematologic adverse event (AE) Grade â‰¥3 in severity, with exceptions;\n * Grade 3 or 4 nonhematologic laboratory abnormality if: clinically significant medical intervention is required or if abnormality leads to hospitalization, persists for >1 week or results in drug-induced liver injury with exceptions;\n * Grade 3 or Grade 4 febrile neutropenia;\n * Prolonged delay (>2 weeks) in initiating Cycle 2 due to treatment-related toxicity;\n * Treatment-related toxicity resulting in participant study treatment discontinuation during Cycle 1;\n * Missing >25% of the MK-5890 dose during Cycle 1 resulting from treatment-related AE;\n * Grade 5 toxicity.|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants in Arms 1 and 2 who experience at least one AE will be presented.|The number of participants in Arms 1 and 2 who discontinue study treatment due to an AE will be presented.","Cycle 1 (Up to 21 days)|Up to 27 months|Up to 24 months","All Arms: Area Under the Concentration-Time Curve (AUC) of MK-5890|All Arms: Minimum Serum Concentration (Cmin) of MK-5890|All Arms: Maximum Serum Concentration (Cmax) of MK-5890|Arms 1 and 2: Objective Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)|Arm 3: Dose-limiting Toxicities (DLTs) Graded Using National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 or Later|Arm 3: Number of Participants with Adverse Events (AEs)|Arm 3: Number of Study Treatment Discontinuations Due to an Adverse Event (AE)","Blood samples will be obtained at designated time points for the assessment of MK-5890 AUC: Cycles 1-4: Day 1: Predose, (end of pembrolizumab infusion for participants receiving pembrolizumab), end of MK-5890 infusion, 2 hours post start of MK-5890 infusion, Days 2, 3, 5, 8 & 15: Once daily; Cycles 5, 6 & every 4 cycles thereafter: Day1: Predose; 30 days post last dose. Each cycle is 21 days. (Up to 25 months)|Blood samples will be obtained at designated time points for the assessment of MK-5890 Cmin: Cycles 1-4: Day 1: Predose, (end of pembrolizumab infusion for participants receiving pembrolizumab), end of MK-5890 infusion, 2 hours post start of MK-5890 infusion, Days 2, 3, 5, 8 & 15: Once daily; Cycles 5, 6 & every 4 cycles thereafter: Day1: Predose; 30 days post last dose. Each cycle is 21 days. (Up to 25 months)|Blood samples will be obtained at designated time points for the assessment of MK-5890 Cmax: Cycles 1-4: Day 1: Predose, (end of pembrolizumab infusion for participants receiving pembrolizumab), end of MK-5890 infusion, 2 hours post start of MK-5890 infusion, Days 2, 3, 5, 8 & 15: Once daily; Cycles 5, 6 & every 4 cycles thereafter: Day1: Predose; 30 days post last dose. Each cycle is 21 days. (Up to 25 months)|The ORR is defined as the percentage of participants who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. The ORR of MK-5890 when used as monotherapy and in combination with pembrolizumab (Arms 1 and 2) as assessed by the investigator will be presented.|A DLT is defined as any of the following toxicities, if assessed by the investigator to be related to study treatment:\n\n * Grade 4 nonhematologic toxicity;\n * Grade 4 hematologic toxicity lasting â‰¥7 days, except thrombocytopenia;\n * Grade 4 thrombocytopenia;\n * Grade 3 thrombocytopenia associated with bleeding that requires a platelet transfusion;\n * Nonhematologic adverse event (AE) Grade â‰¥3 in severity, with exceptions;\n * Grade 3 or 4 nonhematologic laboratory abnormality if: clinically significant medical intervention is required or if abnormality leads to hospitalization, persists for >1 week or results in drug-induced liver injury with exceptions;\n * Grade 3 or Grade 4 febrile neutropenia;\n * Prolonged delay (>2 weeks) in initiating Cycle 2 due to treatment-related toxicity;\n * Treatment-related toxicity resulting in participant study treatment discontinuation during Cycle 1;\n * Missing >25% of the MK-5890 dose during Cycle 1 resulting from treatment-related AE;\n * Grade 5 toxicity.|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants in Arm 3 who experience at least one AE will be presented.|The number of participants in Arm 3 who discontinue study treatment due to an AE will be presented.","At designated time points (Up to 25 months)|Up to 24 months|Cycle 1 (Up to 21 days)|Up to 27 months","Trialsites@merck.com","Toll Free Number","1-888-577-8839","Ramat Gan, Tell Abib, Israel, 5265601|Jerusalem, Yerushalayim, Israel, 9112001|Rotterdam, Netherlands, 3015 Gd|Amsterdam, Noord-Holland, Netherlands, 1066 Cx|Barcelona, Spain, 08916|Mobile, Alabama, United States, 36604|Sarasota, Florida, United States, 34232|Germantown, Tennessee, United States, 38138","Alabama|Florida|Tennessee","Israel|Netherlands|Spain|United States","Tell Abib The Chaim Sheba Medical Center - Oncology Institute ( Site 0001)|Yerushalayim Hadassah Ein Kerem Medical Center ( Site 0010)|Erasmus Mc ( Site 0031)|Noord-Holland Antoni Van Leeuwenhoek Ziekenhuis ( Site 0003)|Instituto Catalan De Oncologia - Ico ( Site 0044)|University Of South Alabama, Mitchell Cancer Institute ( Site 0020)|Florida Cancer Specialists ( Site 0002)|The West Clinic, P.C. ( Site 0021)",{"$nulls":3},"Medical Director","2020-04-09","2020-05-25T16:36:19.458","2020-05-26T17:10:42.972","NCT03396445"]
["5ecbf403feab101b15530854","NCT03396445","2020-04-17","Merck","MRK","Recruiting","Safety and Pharmacokinetics Study of MK-5890 as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Adults With Advanced Solid Tumors (MK-5890-001)","Pembrolizumab|Pemetrexed|Carboplatin","PD-1 Inhibitor|DHFR Antagonist|TS Inhibitor|DNA Synthesis Inhibitor|Mitosis Inhibitor|Tubulin Inhibitor","Unknown",null,"Unknown",null,"Phase 1",3,162,"Anticipated","2018-02-18","2022-10-06","DLT","Dose Limiting Toxicity",{"$nulls":3},"The purpose of this study is to assess the safety and pharmacokinetics of MK-5890 when administered alone and in combination with pembrolizumab (MK-3475) in adults with advanced solid tumors. The initial course of MK-5890 monotherapy or MK-5890 plus pembrolizumab combination therapy will be for up to 35 administrations (approximately 2 years). The safety and pharmacokinetics of MK-5890 when administered with pembrolizumab, pemetrexed and carboplatin will also be assessed in adults with non-squamous non-small cell lung cancer (NSCLC).","Participants receiving MK-5890 monotherapy who experience disease progression may be eligible to switch to receiving MK-5890 plus pembrolizumab combination therapy for up to 35 cycles (approximately 2 years) at the discretion of the Investigator and approval of the Sponsor.","A Phase 1 Study of MK-5890 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors","5890-001","Pharmacokinetics\nSolid Tumor","Oncology Solid Tumor Unspecified|Oncology Unspecified|Other","Oncology Solid Tumor|Oncology Unspecified|Other","Oncology|Other","Experimental","Arm 1: MK-5890|Arm 2: MK-5890 + Pembrolizumab|Arm 3: MK-5890 + Pembrolizumab + Pemetrexed + Carboplatin","Participants receive escalating doses of MK-5890 via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years).|Participants receive escalating doses of MK-5890 via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years).|Participants receive MK-5890 at the selected dose via IV infusion PLUS pembrolizumab 200 mg via IV infusion PLUS pemetrexed 500 mg/m^2 via IV infusion PLUS carboplatin Area Under the Curve (AUC) 5 mg/mL/min via IV infusion, all given on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years).","Drug|Biological","MK-5890|Pembrolizumab|Pemetrexed|Carboplatin","IV infusion","MK-3475|ALIMTAÂ®|PARAPLATINÂ®","Arm 1: MK-5890|Arm 2: MK-5890 + Pembrolizumab|Arm 3: MK-5890 + Pembrolizumab + Pemetrexed + Carboplatin","\n\n * Arms 1 & 2: Histologically or cytologically confirmed advanced/metastatic solid tumor by pathology report and has received or been intolerant to all treatment known to confer clinical benefit.\n * Arm 3: Histologically or cytologically confirmed diagnosis of stage IV (M1a or M1b per current American Joint Committee on Cancer criteria) non-squamous NSCLC.\n * Measureable disease by RECIST 1.1. as assessed by the local site investigator/radiologist. Target lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.\n * Adequate organ function.\n * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n * Male participants must agree to use adequate contraception during the treatment period and for at least 120 days after the last dose of MK-5890 or pembrolizumab OR 180 days after the last dose of chemotherapeutic agents and refrain from donating sperm during this period.\n * Female participants must not be pregnant or breast feeding and agree to follow use adequate contraception during the treatment period and for at least 120 days after the last dose of MK-5890 or pembrolizumab OR 180 days after the last dose of chemotherapeutic agents.\n * Submit an evaluable baseline tumor sample for analysis (either a newly obtained or archival tumor sample).\n\n","\n\n * History of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years.\n * Clinically active central nervous system metastases and/or carcinomatous meningitis.\n * Has had a severe hypersensitivity reaction to treatment with a monoclonal antibody (mAb) and/or other components of the study treatment.\n * Active infection requiring systemic treatment.\n * History of interstitial lung disease.\n * History of (noninfectious) pneumonitis that required steroids or current pneumonitis.\n * Symptomatic ascites or pleural effusion.\n * Previously had a stem cell or bone marrow transplant.\n * Previously had a solid organ transplant.\n * Active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs) except vitiligo or resolved childhood asthma/atopy.\n * Known human immunodeficiency virus (HIV) and/or active and acute Hepatitis B or C infections.\n * Not fully recovered from any effects of major surgery without significant detectable infection.\n * Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study.\n * Had chemotherapy, definitive radiation, or biological cancer therapy within 4 weeks (2 weeks for palliative radiation) before the first dose of study treatment, or has not recovered to Grade â‰¤1 or better from any AEs that were due to cancer therapeutics administered more than 4 weeks earlier.\n * Expected to require any other form of antineoplastic therapy while participating in this study.\n * On chronic systemic steroid therapy in excess of replacement doses (e.g., exceeding 10 mg/day of prednisone equivalent), or on any other form of immunosuppressive medication.\n * Regular user (including \"recreational use\") of any illicit drugs at the time of signing informed consent, or has a recent history (within the last year) of substance abuse (including alcohol), as determined by the treating investigator. Participants who use cannabis for medicinal purposes or to treat specific symptoms will not be excluded unless it is being abused in the opinion of the treating investigator.\n * Received a live-virus vaccine within 28 days before the first dose of study treatment.\n * Currently participating and receiving study treatment in a study of an investigational agent or has participated and received study treatment in a study of an investigational agent or has used an investigational device within 28 days before the first dose of study treatment.\n\nAdditional Exclusion Criteria for Participants in Arm 3:\n\n * Has received radiation therapy to the lung that is >30 Gray (Gy) within 6 months before the first dose of study treatment.\n * Is unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs), other than an aspirin dose â‰¤1.3 g per day, for a 5-day period (8-day period for long-acting agents, such as piroxicam).\n * Is unable or unwilling to take folic acid or vitamin B12 supplementation.",{"$nulls":4},"Actual","2018-01-11","Actual","Anticipated","2022-10-06","Anticipated","2020-04-01","2018-01-04","2018-01-04","2020-04-16","No",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No","Yes\nhttp://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf",{"$nulls":3},"Yes","No",{"$nulls":17},"MK-5890-001","Merck Protocol Number","Arms 1 and 2: Dose-limiting Toxicities (DLTs) Graded Using National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 or Later|Arms 1 and 2: Number of Participants with Adverse Events (AEs)|Arms 1 and 2: Number of Study Treatment Discontinuations Due to an Adverse Event (AE)","A DLT is defined as any of the following toxicities, if assessed by the investigator to be related to study treatment:\n\n * Grade 4 nonhematologic toxicity;\n * Grade 4 hematologic toxicity lasting â‰¥7 days, except thrombocytopenia;\n * Grade 4 thrombocytopenia;\n * Grade 3 thrombocytopenia associated with bleeding that requires a platelet transfusion;\n * Nonhematologic adverse event (AE) Grade â‰¥3 in severity, with exceptions;\n * Grade 3 or 4 nonhematologic laboratory abnormality if: clinically significant medical intervention is required or if abnormality leads to hospitalization, persists for >1 week or results in drug-induced liver injury with exceptions;\n * Grade 3 or Grade 4 febrile neutropenia;\n * Prolonged delay (>2 weeks) in initiating Cycle 2 due to treatment-related toxicity;\n * Treatment-related toxicity resulting in participant study treatment discontinuation during Cycle 1;\n * Missing >25% of the MK-5890 dose during Cycle 1 resulting from treatment-related AE;\n * Grade 5 toxicity.|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants in Arms 1 and 2 who experience at least one AE will be presented.|The number of participants in Arms 1 and 2 who discontinue study treatment due to an AE will be presented.","Cycle 1 (Up to 21 days)|Up to 27 months|Up to 24 months","All Arms: Area Under the Concentration-Time Curve (AUC) of MK-5890|All Arms: Minimum Serum Concentration (Cmin) of MK-5890|All Arms: Maximum Serum Concentration (Cmax) of MK-5890|Arms 1 and 2: Objective Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)|Arm 3: Dose-limiting Toxicities (DLTs) Graded Using National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 or Later|Arm 3: Number of Participants with Adverse Events (AEs)|Arm 3: Number of Study Treatment Discontinuations Due to an Adverse Event (AE)","Blood samples will be obtained at designated time points for the assessment of MK-5890 AUC: Cycles 1-4: Day 1: Predose, (end of pembrolizumab infusion for participants receiving pembrolizumab), end of MK-5890 infusion, 2 hours post start of MK-5890 infusion, Days 2, 3, 5, 8 & 15: Once daily; Cycles 5, 6 & every 4 cycles thereafter: Day1: Predose; 30 days post last dose. Each cycle is 21 days. (Up to 25 months)|Blood samples will be obtained at designated time points for the assessment of MK-5890 Cmin: Cycles 1-4: Day 1: Predose, (end of pembrolizumab infusion for participants receiving pembrolizumab), end of MK-5890 infusion, 2 hours post start of MK-5890 infusion, Days 2, 3, 5, 8 & 15: Once daily; Cycles 5, 6 & every 4 cycles thereafter: Day1: Predose; 30 days post last dose. Each cycle is 21 days. (Up to 25 months)|Blood samples will be obtained at designated time points for the assessment of MK-5890 Cmax: Cycles 1-4: Day 1: Predose, (end of pembrolizumab infusion for participants receiving pembrolizumab), end of MK-5890 infusion, 2 hours post start of MK-5890 infusion, Days 2, 3, 5, 8 & 15: Once daily; Cycles 5, 6 & every 4 cycles thereafter: Day1: Predose; 30 days post last dose. Each cycle is 21 days. (Up to 25 months)|The ORR is defined as the percentage of participants who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. The ORR of MK-5890 when used as monotherapy and in combination with pembrolizumab (Arms 1 and 2) as assessed by the investigator will be presented.|A DLT is defined as any of the following toxicities, if assessed by the investigator to be related to study treatment:\n\n * Grade 4 nonhematologic toxicity;\n * Grade 4 hematologic toxicity lasting â‰¥7 days, except thrombocytopenia;\n * Grade 4 thrombocytopenia;\n * Grade 3 thrombocytopenia associated with bleeding that requires a platelet transfusion;\n * Nonhematologic adverse event (AE) Grade â‰¥3 in severity, with exceptions;\n * Grade 3 or 4 nonhematologic laboratory abnormality if: clinically significant medical intervention is required or if abnormality leads to hospitalization, persists for >1 week or results in drug-induced liver injury with exceptions;\n * Grade 3 or Grade 4 febrile neutropenia;\n * Prolonged delay (>2 weeks) in initiating Cycle 2 due to treatment-related toxicity;\n * Treatment-related toxicity resulting in participant study treatment discontinuation during Cycle 1;\n * Missing >25% of the MK-5890 dose during Cycle 1 resulting from treatment-related AE;\n * Grade 5 toxicity.|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants in Arm 3 who experience at least one AE will be presented.|The number of participants in Arm 3 who discontinue study treatment due to an AE will be presented.","At designated time points (Up to 25 months)|Up to 24 months|Cycle 1 (Up to 21 days)|Up to 27 months","Trialsites@merck.com","Toll Free Number","1-888-577-8839","Ramat Gan, Tell Abib, Israel, 5265601|Jerusalem, Yerushalayim, Israel, 9112001|Amsterdam, Noord-Holland, Netherlands, 1066 Cx|Rotterdam, Zuid-Holland, Netherlands, 3015 Gd|Barcelona, Barcelona [Barcelona], Spain, 08916|Madrid, Spain, 28040|Mobile, Alabama, United States, 36604|Sarasota, Florida, United States, 34232|Germantown, Tennessee, United States, 38138","Alabama|Florida|Tennessee","Israel|Netherlands|Spain|United States","Tell Abib The Chaim Sheba Medical Center - Oncology Institute ( Site 0001)|Yerushalayim Hadassah Ein Kerem Medical Center ( Site 0010)|Noord-Holland Antoni Van Leeuwenhoek Ziekenhuis ( Site 0003)|Zuid-Holland Erasmus Mc ( Site 0031)|Barcelona [Barcelona] Instituto Catalan De Oncologia - Ico ( Site 0044)|Hospital Universitario Fundacion Jimenez Diaz ( Site 0041)|University Of South Alabama, Mitchell Cancer Institute ( Site 0020)|Florida Cancer Specialists ( Site 0002)|The West Clinic, P.C. ( Site 0021)",{"$nulls":3},"Medical Director","2020-04-16","2020-05-25T16:36:19.567","2020-05-26T17:10:42.972","NCT03396445"]
["5ecbf403fe30261b1a048224","NCT03396445","2020-05-06","Merck","MRK","Recruiting","Safety and Pharmacokinetics Study of MK-5890 as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Adults With Advanced Solid Tumors (MK-5890-001)","Pembrolizumab|Pemetrexed|Carboplatin","PD-1 Inhibitor|DHFR Antagonist|TS Inhibitor|DNA Synthesis Inhibitor|Mitosis Inhibitor|Tubulin Inhibitor","Unknown",null,"Unknown",null,"Phase 1",3,162,"Anticipated","2018-02-18","2022-10-06","DLT","Dose Limiting Toxicity",{"$nulls":3},"The purpose of this study is to assess the safety and pharmacokinetics of MK-5890 when administered alone and in combination with pembrolizumab (MK-3475) in adults with advanced solid tumors. The initial course of MK-5890 monotherapy or MK-5890 plus pembrolizumab combination therapy will be for up to 35 administrations (approximately 2 years). The safety and pharmacokinetics of MK-5890 when administered with pembrolizumab, pemetrexed and carboplatin will also be assessed in adults with non-squamous non-small cell lung cancer (NSCLC).","Participants receiving MK-5890 monotherapy who experience disease progression may be eligible to switch to receiving MK-5890 plus pembrolizumab combination therapy for up to 35 cycles (approximately 2 years) at the discretion of the Investigator and approval of the Sponsor.","A Phase 1 Study of MK-5890 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors","5890-001","Pharmacokinetics\nSolid Tumor","Oncology Solid Tumor Unspecified|Oncology Unspecified|Other","Oncology Solid Tumor|Oncology Unspecified|Other","Oncology|Other","Experimental","Arm 1: MK-5890|Arm 2: MK-5890 + Pembrolizumab|Arm 3: MK-5890 + Pembrolizumab + Pemetrexed + Carboplatin","Participants receive escalating doses of MK-5890 via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years).|Participants receive escalating doses of MK-5890 via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years).|Participants receive MK-5890 at the selected dose via IV infusion PLUS pembrolizumab 200 mg via IV infusion PLUS pemetrexed 500 mg/m^2 via IV infusion PLUS carboplatin Area Under the Curve (AUC) 5 mg/mL/min via IV infusion, all given on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years).","Drug|Biological","MK-5890|Pembrolizumab|Pemetrexed|Carboplatin","IV infusion","MK-3475|ALIMTAÂ®|PARAPLATINÂ®","Arm 1: MK-5890|Arm 2: MK-5890 + Pembrolizumab|Arm 3: MK-5890 + Pembrolizumab + Pemetrexed + Carboplatin","\n\n * Arms 1 & 2: Histologically or cytologically confirmed advanced/metastatic solid tumor by pathology report and has received or been intolerant to all treatment known to confer clinical benefit.\n * Arm 3: Histologically or cytologically confirmed diagnosis of stage IV (M1a or M1b per current American Joint Committee on Cancer criteria) non-squamous NSCLC.\n * Measureable disease by RECIST 1.1. as assessed by the local site investigator/radiologist. Target lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.\n * Adequate organ function.\n * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n * Male participants must agree to use adequate contraception during the treatment period and for at least 120 days after the last dose of MK-5890 or pembrolizumab OR 180 days after the last dose of chemotherapeutic agents and refrain from donating sperm during this period.\n * Female participants must not be pregnant or breast feeding and agree to follow use adequate contraception during the treatment period and for at least 120 days after the last dose of MK-5890 or pembrolizumab OR 180 days after the last dose of chemotherapeutic agents.\n * Submit an evaluable baseline tumor sample for analysis (either a newly obtained or archival tumor sample).\n\n","\n\n * History of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years.\n * Clinically active central nervous system metastases and/or carcinomatous meningitis.\n * Has had a severe hypersensitivity reaction to treatment with a monoclonal antibody (mAb) and/or other components of the study treatment.\n * Active infection requiring systemic treatment.\n * History of interstitial lung disease.\n * History of (noninfectious) pneumonitis that required steroids or current pneumonitis.\n * Symptomatic ascites or pleural effusion.\n * Previously had a stem cell or bone marrow transplant.\n * Previously had a solid organ transplant.\n * Active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs) except vitiligo or resolved childhood asthma/atopy.\n * Known human immunodeficiency virus (HIV) and/or active and acute Hepatitis B or C infections.\n * Not fully recovered from any effects of major surgery without significant detectable infection.\n * Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study.\n * Had chemotherapy, definitive radiation, or biological cancer therapy within 4 weeks (2 weeks for palliative radiation) before the first dose of study treatment, or has not recovered to Grade â‰¤1 or better from any AEs that were due to cancer therapeutics administered more than 4 weeks earlier.\n * Expected to require any other form of antineoplastic therapy while participating in this study.\n * On chronic systemic steroid therapy in excess of replacement doses (e.g., exceeding 10 mg/day of prednisone equivalent), or on any other form of immunosuppressive medication.\n * Regular user (including \"recreational use\") of any illicit drugs at the time of signing informed consent, or has a recent history (within the last year) of substance abuse (including alcohol), as determined by the treating investigator. Participants who use cannabis for medicinal purposes or to treat specific symptoms will not be excluded unless it is being abused in the opinion of the treating investigator.\n * Received a live-virus vaccine within 28 days before the first dose of study treatment.\n * Currently participating and receiving study treatment in a study of an investigational agent or has participated and received study treatment in a study of an investigational agent or has used an investigational device within 28 days before the first dose of study treatment.\n\nAdditional Exclusion Criteria for Participants in Arm 3:\n\n * Has received radiation therapy to the lung that is >30 Gray (Gy) within 6 months before the first dose of study treatment.\n * Is unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs), other than an aspirin dose â‰¤1.3 g per day, for a 5-day period (8-day period for long-acting agents, such as piroxicam).\n * Is unable or unwilling to take folic acid or vitamin B12 supplementation.",{"$nulls":4},"Actual","2018-01-11","Actual","Anticipated","2022-10-06","Anticipated","2020-05-01","2018-01-04","2018-01-04","2020-05-05","No",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No","Yes\nhttp://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf",{"$nulls":3},"Yes","No",{"$nulls":17},"MK-5890-001","Merck Protocol Number","Arms 1 and 2: Dose-limiting Toxicities (DLTs) Graded Using National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 or Later|Arms 1 and 2: Number of Participants with Adverse Events (AEs)|Arms 1 and 2: Number of Study Treatment Discontinuations Due to an Adverse Event (AE)","A DLT is defined as any of the following toxicities, if assessed by the investigator to be related to study treatment:\n\n * Grade 4 nonhematologic toxicity;\n * Grade 4 hematologic toxicity lasting â‰¥7 days, except thrombocytopenia;\n * Grade 4 thrombocytopenia;\n * Grade 3 thrombocytopenia associated with bleeding that requires a platelet transfusion;\n * Nonhematologic adverse event (AE) Grade â‰¥3 in severity, with exceptions;\n * Grade 3 or 4 nonhematologic laboratory abnormality if: clinically significant medical intervention is required or if abnormality leads to hospitalization, persists for >1 week or results in drug-induced liver injury with exceptions;\n * Grade 3 or Grade 4 febrile neutropenia;\n * Prolonged delay (>2 weeks) in initiating Cycle 2 due to treatment-related toxicity;\n * Treatment-related toxicity resulting in participant study treatment discontinuation during Cycle 1;\n * Missing >25% of the MK-5890 dose during Cycle 1 resulting from treatment-related AE;\n * Grade 5 toxicity.|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants in Arms 1 and 2 who experience at least one AE will be presented.|The number of participants in Arms 1 and 2 who discontinue study treatment due to an AE will be presented.","Cycle 1 (Up to 21 days)|Up to 27 months|Up to 24 months","All Arms: Area Under the Concentration-Time Curve (AUC) of MK-5890|All Arms: Minimum Serum Concentration (Cmin) of MK-5890|All Arms: Maximum Serum Concentration (Cmax) of MK-5890|Arms 1 and 2: Objective Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)|Arm 3: Dose-limiting Toxicities (DLTs) Graded Using National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 or Later|Arm 3: Number of Participants with Adverse Events (AEs)|Arm 3: Number of Study Treatment Discontinuations Due to an Adverse Event (AE)","Blood samples will be obtained at designated time points for the assessment of MK-5890 AUC: Cycles 1-4: Day 1: Predose, (end of pembrolizumab infusion for participants receiving pembrolizumab), end of MK-5890 infusion, 2 hours post start of MK-5890 infusion, Days 2, 3, 5, 8 & 15: Once daily; Cycles 5, 6 & every 4 cycles thereafter: Day1: Predose; 30 days post last dose. Each cycle is 21 days. (Up to 25 months)|Blood samples will be obtained at designated time points for the assessment of MK-5890 Cmin: Cycles 1-4: Day 1: Predose, (end of pembrolizumab infusion for participants receiving pembrolizumab), end of MK-5890 infusion, 2 hours post start of MK-5890 infusion, Days 2, 3, 5, 8 & 15: Once daily; Cycles 5, 6 & every 4 cycles thereafter: Day1: Predose; 30 days post last dose. Each cycle is 21 days. (Up to 25 months)|Blood samples will be obtained at designated time points for the assessment of MK-5890 Cmax: Cycles 1-4: Day 1: Predose, (end of pembrolizumab infusion for participants receiving pembrolizumab), end of MK-5890 infusion, 2 hours post start of MK-5890 infusion, Days 2, 3, 5, 8 & 15: Once daily; Cycles 5, 6 & every 4 cycles thereafter: Day1: Predose; 30 days post last dose. Each cycle is 21 days. (Up to 25 months)|The ORR is defined as the percentage of participants who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. The ORR of MK-5890 when used as monotherapy and in combination with pembrolizumab (Arms 1 and 2) as assessed by the investigator will be presented.|A DLT is defined as any of the following toxicities, if assessed by the investigator to be related to study treatment:\n\n * Grade 4 nonhematologic toxicity;\n * Grade 4 hematologic toxicity lasting â‰¥7 days, except thrombocytopenia;\n * Grade 4 thrombocytopenia;\n * Grade 3 thrombocytopenia associated with bleeding that requires a platelet transfusion;\n * Nonhematologic adverse event (AE) Grade â‰¥3 in severity, with exceptions;\n * Grade 3 or 4 nonhematologic laboratory abnormality if: clinically significant medical intervention is required or if abnormality leads to hospitalization, persists for >1 week or results in drug-induced liver injury with exceptions;\n * Grade 3 or Grade 4 febrile neutropenia;\n * Prolonged delay (>2 weeks) in initiating Cycle 2 due to treatment-related toxicity;\n * Treatment-related toxicity resulting in participant study treatment discontinuation during Cycle 1;\n * Missing >25% of the MK-5890 dose during Cycle 1 resulting from treatment-related AE;\n * Grade 5 toxicity.|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants in Arm 3 who experience at least one AE will be presented.|The number of participants in Arm 3 who discontinue study treatment due to an AE will be presented.","At designated time points (Up to 25 months)|Up to 24 months|Cycle 1 (Up to 21 days)|Up to 27 months","Trialsites@merck.com","Toll Free Number","1-888-577-8839","Ramat Gan, Tell Abib, Israel, 5265601|Jerusalem, Yerushalayim, Israel, 9101002|Amsterdam, Noord-Holland, Netherlands, 1066 Cx|Rotterdam, Zuid-Holland, Netherlands, 3015 Gd|Barcelona, Barcelona [Barcelona], Spain, 08916|Madrid, Spain, 28040|Mobile, Alabama, United States, 36604|Sarasota, Florida, United States, 34232|Germantown, Tennessee, United States, 38138","Alabama|Florida|Tennessee","Israel|Netherlands|Spain|United States","Tell Abib The Chaim Sheba Medical Center - Oncology Institute ( Site 0001)|Yerushalayim Hadassah Ein Kerem Medical Center ( Site 0010)|Noord-Holland Antoni Van Leeuwenhoek Ziekenhuis ( Site 0003)|Zuid-Holland Erasmus Mc ( Site 0031)|Barcelona [Barcelona] Instituto Catalan De Oncologia - Ico ( Site 0044)|Hospital Universitario Fundacion Jimenez Diaz ( Site 0041)|University Of South Alabama, Mitchell Cancer Institute ( Site 0020)|Florida Cancer Specialists ( Site 0002)|The West Clinic, P.C. ( Site 0021)",{"$nulls":3},"Medical Director","2020-05-05","2020-05-25T16:36:19.605","2020-05-26T17:10:42.972","NCT03396445"]
["5ecbf40411702c1b1b916a35","NCT03396445","2020-05-18","Merck","MRK","Recruiting","Safety and Pharmacokinetics Study of MK-5890 as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Adults With Advanced Solid Tumors (MK-5890-001)","Pembrolizumab|Pemetrexed|Carboplatin","PD-1 Inhibitor|DHFR Antagonist|TS Inhibitor|DNA Synthesis Inhibitor|Mitosis Inhibitor|Tubulin Inhibitor","Unknown",null,"Unknown",null,"Phase 1",3,162,"Anticipated","2018-02-18","2022-10-06","DLT","Dose Limiting Toxicity",{"$nulls":3},"The purpose of this study is to assess the safety and pharmacokinetics of MK-5890 when administered alone and in combination with pembrolizumab (MK-3475) in adults with advanced solid tumors. The initial course of MK-5890 monotherapy or MK-5890 plus pembrolizumab combination therapy will be for up to 35 administrations (approximately 2 years). The safety and pharmacokinetics of MK-5890 when administered with pembrolizumab, pemetrexed and carboplatin will also be assessed in adults with non-squamous non-small cell lung cancer (NSCLC).","Participants receiving MK-5890 monotherapy who experience disease progression may be eligible to switch to receiving MK-5890 plus pembrolizumab combination therapy for up to 35 cycles (approximately 2 years) at the discretion of the Investigator and approval of the Sponsor.","A Phase 1 Study of MK-5890 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors","5890-001","Pharmacokinetics\nSolid Tumor","Oncology Solid Tumor Unspecified|Oncology Unspecified|Other","Oncology Solid Tumor|Oncology Unspecified|Other","Oncology|Other","Experimental","Arm 1: MK-5890|Arm 2: MK-5890 + Pembrolizumab|Arm 3: MK-5890 + Pembrolizumab + Pemetrexed + Carboplatin","Participants receive escalating doses of MK-5890 via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years).|Participants receive escalating doses of MK-5890 via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years).|Participants receive MK-5890 at the selected dose via IV infusion PLUS pembrolizumab 200 mg via IV infusion PLUS pemetrexed 500 mg/m^2 via IV infusion PLUS carboplatin Area Under the Curve (AUC) 5 mg/mL/min via IV infusion, all given on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years).","Drug|Biological","MK-5890|Pembrolizumab|Pemetrexed|Carboplatin","IV infusion","MK-3475|ALIMTAÂ®|PARAPLATINÂ®","Arm 1: MK-5890|Arm 2: MK-5890 + Pembrolizumab|Arm 3: MK-5890 + Pembrolizumab + Pemetrexed + Carboplatin","\n\n * Arms 1 & 2: Histologically or cytologically confirmed advanced/metastatic solid tumor by pathology report and has received or been intolerant to all treatment known to confer clinical benefit.\n * Arm 3: Histologically or cytologically confirmed diagnosis of stage IV (M1a or M1b per current American Joint Committee on Cancer criteria) non-squamous NSCLC.\n * Measureable disease by RECIST 1.1. as assessed by the local site investigator/radiologist. Target lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.\n * Adequate organ function.\n * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n * Male participants must agree to use adequate contraception during the treatment period and for at least 120 days after the last dose of MK-5890 or pembrolizumab OR 180 days after the last dose of chemotherapeutic agents and refrain from donating sperm during this period.\n * Female participants must not be pregnant or breast feeding and agree to follow use adequate contraception during the treatment period and for at least 120 days after the last dose of MK-5890 or pembrolizumab OR 180 days after the last dose of chemotherapeutic agents.\n * Submit an evaluable baseline tumor sample for analysis (either a newly obtained or archival tumor sample).\n\n","\n\n * History of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years.\n * Clinically active central nervous system metastases and/or carcinomatous meningitis.\n * Has had a severe hypersensitivity reaction to treatment with a monoclonal antibody (mAb) and/or other components of the study treatment.\n * Active infection requiring systemic treatment.\n * History of interstitial lung disease.\n * History of (noninfectious) pneumonitis that required steroids or current pneumonitis.\n * Symptomatic ascites or pleural effusion.\n * Previously had a stem cell or bone marrow transplant.\n * Previously had a solid organ transplant.\n * Active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs) except vitiligo or resolved childhood asthma/atopy.\n * Known human immunodeficiency virus (HIV) and/or active and acute Hepatitis B or C infections.\n * Not fully recovered from any effects of major surgery without significant detectable infection.\n * Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study.\n * Had chemotherapy, definitive radiation, or biological cancer therapy within 4 weeks (2 weeks for palliative radiation) before the first dose of study treatment, or has not recovered to Grade â‰¤1 or better from any AEs that were due to cancer therapeutics administered more than 4 weeks earlier.\n * Expected to require any other form of antineoplastic therapy while participating in this study.\n * On chronic systemic steroid therapy in excess of replacement doses (e.g., exceeding 10 mg/day of prednisone equivalent), or on any other form of immunosuppressive medication.\n * Regular user (including \"recreational use\") of any illicit drugs at the time of signing informed consent, or has a recent history (within the last year) of substance abuse (including alcohol), as determined by the treating investigator. Participants who use cannabis for medicinal purposes or to treat specific symptoms will not be excluded unless it is being abused in the opinion of the treating investigator.\n * Received a live-virus vaccine within 28 days before the first dose of study treatment.\n * Currently participating and receiving study treatment in a study of an investigational agent or has participated and received study treatment in a study of an investigational agent or has used an investigational device within 28 days before the first dose of study treatment.\n\nAdditional Exclusion Criteria for Participants in Arm 3:\n\n * Has received radiation therapy to the lung that is >30 Gray (Gy) within 6 months before the first dose of study treatment.\n * Is unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs), other than an aspirin dose â‰¤1.3 g per day, for a 5-day period (8-day period for long-acting agents, such as piroxicam).\n * Is unable or unwilling to take folic acid or vitamin B12 supplementation.",{"$nulls":4},"Actual","2018-01-11","Actual","Anticipated","2022-10-06","Anticipated","2020-05-01","2018-01-04","2018-01-04","2020-05-15","No",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No","Yes\nhttp://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf",{"$nulls":3},"Yes","No",{"$nulls":17},"MK-5890-001","Merck Protocol Number","Arms 1 and 2: Dose-limiting Toxicities (DLTs) Graded Using National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 or Later|Arms 1 and 2: Number of Participants with Adverse Events (AEs)|Arms 1 and 2: Number of Study Treatment Discontinuations Due to an Adverse Event (AE)","A DLT is defined as any of the following toxicities, if assessed by the investigator to be related to study treatment:\n\n * Grade 4 nonhematologic toxicity;\n * Grade 4 hematologic toxicity lasting â‰¥7 days, except thrombocytopenia;\n * Grade 4 thrombocytopenia;\n * Grade 3 thrombocytopenia associated with bleeding that requires a platelet transfusion;\n * Nonhematologic adverse event (AE) Grade â‰¥3 in severity, with exceptions;\n * Grade 3 or 4 nonhematologic laboratory abnormality if: clinically significant medical intervention is required or if abnormality leads to hospitalization, persists for >1 week or results in drug-induced liver injury with exceptions;\n * Grade 3 or Grade 4 febrile neutropenia;\n * Prolonged delay (>2 weeks) in initiating Cycle 2 due to treatment-related toxicity;\n * Treatment-related toxicity resulting in participant study treatment discontinuation during Cycle 1;\n * Missing >25% of the MK-5890 dose during Cycle 1 resulting from treatment-related AE;\n * Grade 5 toxicity.|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants in Arms 1 and 2 who experience at least one AE will be presented.|The number of participants in Arms 1 and 2 who discontinue study treatment due to an AE will be presented.","Cycle 1 (Up to 21 days)|Up to 27 months|Up to 24 months","All Arms: Area Under the Concentration-Time Curve (AUC) of MK-5890|All Arms: Minimum Serum Concentration (Cmin) of MK-5890|All Arms: Maximum Serum Concentration (Cmax) of MK-5890|Arms 1 and 2: Objective Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)|Arm 3: Dose-limiting Toxicities (DLTs) Graded Using National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 or Later|Arm 3: Number of Participants with Adverse Events (AEs)|Arm 3: Number of Study Treatment Discontinuations Due to an Adverse Event (AE)","Blood samples will be obtained at designated time points for the assessment of MK-5890 AUC: Cycles 1-4: Day 1: Predose, (end of pembrolizumab infusion for participants receiving pembrolizumab), end of MK-5890 infusion, 2 hours post start of MK-5890 infusion, Days 2, 3, 5, 8 & 15: Once daily; Cycles 5, 6 & every 4 cycles thereafter: Day1: Predose; 30 days post last dose. Each cycle is 21 days. (Up to 25 months)|Blood samples will be obtained at designated time points for the assessment of MK-5890 Cmin: Cycles 1-4: Day 1: Predose, (end of pembrolizumab infusion for participants receiving pembrolizumab), end of MK-5890 infusion, 2 hours post start of MK-5890 infusion, Days 2, 3, 5, 8 & 15: Once daily; Cycles 5, 6 & every 4 cycles thereafter: Day1: Predose; 30 days post last dose. Each cycle is 21 days. (Up to 25 months)|Blood samples will be obtained at designated time points for the assessment of MK-5890 Cmax: Cycles 1-4: Day 1: Predose, (end of pembrolizumab infusion for participants receiving pembrolizumab), end of MK-5890 infusion, 2 hours post start of MK-5890 infusion, Days 2, 3, 5, 8 & 15: Once daily; Cycles 5, 6 & every 4 cycles thereafter: Day1: Predose; 30 days post last dose. Each cycle is 21 days. (Up to 25 months)|The ORR is defined as the percentage of participants who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. The ORR of MK-5890 when used as monotherapy and in combination with pembrolizumab (Arms 1 and 2) as assessed by the investigator will be presented.|A DLT is defined as any of the following toxicities, if assessed by the investigator to be related to study treatment:\n\n * Grade 4 nonhematologic toxicity;\n * Grade 4 hematologic toxicity lasting â‰¥7 days, except thrombocytopenia;\n * Grade 4 thrombocytopenia;\n * Grade 3 thrombocytopenia associated with bleeding that requires a platelet transfusion;\n * Nonhematologic adverse event (AE) Grade â‰¥3 in severity, with exceptions;\n * Grade 3 or 4 nonhematologic laboratory abnormality if: clinically significant medical intervention is required or if abnormality leads to hospitalization, persists for >1 week or results in drug-induced liver injury with exceptions;\n * Grade 3 or Grade 4 febrile neutropenia;\n * Prolonged delay (>2 weeks) in initiating Cycle 2 due to treatment-related toxicity;\n * Treatment-related toxicity resulting in participant study treatment discontinuation during Cycle 1;\n * Missing >25% of the MK-5890 dose during Cycle 1 resulting from treatment-related AE;\n * Grade 5 toxicity.|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants in Arm 3 who experience at least one AE will be presented.|The number of participants in Arm 3 who discontinue study treatment due to an AE will be presented.","At designated time points (Up to 25 months)|Up to 24 months|Cycle 1 (Up to 21 days)|Up to 27 months","Trialsites@merck.com","Toll Free Number","1-888-577-8839","Ramat Gan, Tell Abib, Israel, 5265601|Jerusalem, Yerushalayim, Israel, 9101002|Amsterdam, Noord-Holland, Netherlands, 1066 Cx|Rotterdam, Zuid-Holland, Netherlands, 3015 Gd|Barcelona, Barcelona [Barcelona], Spain, 08916|Madrid, Spain, 28040|Pozuelo De Alarcon, Madrid, Spain, 28223|Mobile, Alabama, United States, 36604|Sarasota, Florida, United States, 34232|Germantown, Tennessee, United States, 38138","Alabama|Florida|Tennessee","Israel|Netherlands|Spain|United States","Tell Abib The Chaim Sheba Medical Center - Oncology Institute ( Site 0001)|Yerushalayim Hadassah Ein Kerem Medical Center ( Site 0010)|Noord-Holland Antoni Van Leeuwenhoek Ziekenhuis ( Site 0003)|Zuid-Holland Erasmus Mc ( Site 0031)|Barcelona [Barcelona] Instituto Catalan De Oncologia - Ico ( Site 0044)|Hospital Universitario Fundacion Jimenez Diaz ( Site 0041)|Madrid Hospital Universitario Quiron Madrid ( Site 0043)|University Of South Alabama, Mitchell Cancer Institute ( Site 0020)|Florida Cancer Specialists ( Site 0002)|The West Clinic, P.C. ( Site 0021)",{"$nulls":3},"Medical Director","2020-05-15","2020-05-25T16:36:20.090","2020-05-26T17:10:42.972","NCT03396445"]
["5ecbf406307e3d1b1f8d9cbb","NCT03397121","2018-01-11","The Medicines Company","MDCO","Recruiting","A Study Of Inclisiran In Participants With Heterozygous Familial Hypercholesterolemia and Elevated Cholesterol. (ORION-9)","Inclisiran",null,"Yes","['Inclisiran']","Unknown",null,"Phase 3",2,400,"Anticipated","2017-11-28","2019-09-01",{"$nulls":5},"This is a Phase III, placebo-controlled, double-blind, randomized study in participants with HeFH and elevated LDL-C to evaluate the efficacy, safety, and tolerability of subcutaneous (SC) injection(s) of inclisiran. The study will be multicenter and international.",null,"Placebo-Controlled, Double-Blind, Randomized Trial to Evaluate the Effect of 300 mg of Inclisiran Sodium Given as Subcutaneous Injections in Subjects With Heterozygous Familial Hypercholesterolemia (HeFH) and Elevated Low-Density Lipoprotein Cholesterol (LDL-C).","MDCO-PCS-17-03","Heterozygous Familial Hypercholesterolemia\nElevated Cholesterol","Hypercholesterolemia","Metabolic Diseases","Nutritional Disorders","Experimental|Placebo Comparator","Inclisiran|Placebo","Inclisiran sodium 300 milligrams (mg) will be administered as a SC injection on Day 1, Day 90 then every 6 months.|Placebo will be administered as SC injections of saline solution on Day 1, Day 90 then every 6 months.","Drug","Inclisiran|Placebo","Inclisiran is a small interfering ribonucleic acid (RNA) that inhibits PCSK9 synthesis.|Placebo will be supplied as sterile normal saline (0.9% sodium chloride in water for injection).","Saline Solution","Inclisiran|Placebo","\n\nParticipants may be included if they meet all of the following inclusion criteria prior to randomization:\n\n 1. Male or female participants â‰¥18 years of age.\n 2. History of HeFH with a diagnosis of HeFH by genetic testing; and/or a documented history of untreated LDL-C of >190 mg/dL, and a family history of familial hypercholesterolemia, elevated cholesterol or early heart disease that may indicate familial hypercholesterolemia.\n 3. Serum LDL-C â‰¥2.6 millimoles (mmol)/liter (L) (â‰¥100 mg/dL) at screening.\n 4. Fasting triglyceride <4.52 mmol/L (<400 mg/dL) at screening.\n 5. Participants on statins should be receiving a maximally tolerated dose.\n 6. Participants not receiving statins must have documented evidence of intolerance to all doses of at least 2 different statins.\n 7. Participants on lipid-lowering therapies (such as a statin and/or ezetimibe) should be on a stable dose for â‰¥30 days before screening with no planned medication or dose change during study participation.\n\n","\n\nParticipants will be excluded from the study if any of the following exclusion criteria apply immediately prior to randomization:\n\n 1. New York Heart Association (NYHA) class IV heart failure.\n 2. Uncontrolled cardiac arrhythmia\n 3. Uncontrolled severe hypertension\n 4. Active liver disease\n 5. Females who are pregnant or nursing, or who are of childbearing potential and unwilling to use at least 2 methods of highly effective contraception (failure rate less than 1% per year) (combined oral contraceptives, barrier methods, approved contraceptive implant, long-term injectable contraception, or intrauterine device) for the entire duration of the study. Exemptions from this criterion: 1. Women >2 years postmenopausal (defined as 1 year or longer since last menstrual period) AND more than 55 years of age.\n     2. Postmenopausal women (as defined above) and less than 55 years of age with a negative pregnancy test within 24 hours of randomization.\n     3. Women who are surgically sterilized at least 3 months prior to enrollment.\n    \n    \n 6. Males who are unwilling to use an acceptable method of birth control during the entire study period (condom with spermicide).\n 7. Treatment with other investigational products or devices within 30 days or 5 half-lives of the screening visit, whichever is longer.\n 8. Treatment (within 90 days of screening) with monoclonal antibodies directed towards PCSK9.\n\nThe above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.",{"$nulls":4},"Actual","2018-01-11","Actual","Anticipated","2019-09-01","Anticipated","2018-01-01","2018-01-02","2018-01-05","2018-01-05","Yes","HeFH\nLDL-C\nInclisiran","Interventional","Treatment","Parallel Assignment","Double (Participant, Care Provider)","Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"2017-002472-30","EudraCT Number","Percentage Change In LDL-C from Baseline To Day 510|Time-adjusted Percentage Change In LDL-C From Baseline Between Day 90 And Day 540","Baseline, Day 510|Baseline, Day 90 to Day 540",null,"Absolute Change in LDL-C from Baseline to Day 510|Time-adjusted Absolute Change in LDL-C from Baseline Between Day 90 and Day 540|Percentage Change in Proprotein Convertase Subtilisin/kexin Type 9 (PCSK9) from Baseline to Day 510|Percentage Change in Total Cholesterol from Baseline to Day 510|Percentage Change in Apolipoprotein B (ApoB) from Baseline To Day 510|Percentage Change in Non-high-density Lipoprotein (HDL)-C from Baseline To Day 510","Baseline, Day 510|Baseline, Day 540",null,"medical.information@themedco.com","The Medicines Company Global Health Science Center","1-888-977-6326","London, Ontario, Canada, N6A 5B7|Chicoutimi, Quebec, Canada, G7H 7K9 Clinical Research Institute Of MontrealMontrÃ©al, Quebec, Canada, H2W 1R7 Royal Victoria HospitalMontrÃ©al, Quebec, Canada, H4A 3J1 Clinique Des Maladies Lipidiques De Quebec, Inc.Quebec City, Quebec, Canada, G1V 4W2 Centre Hospitalier Universitaire De Sherbrooke ChusSherbrooke, Quebec, Canada, J1H 5N4|Hradec KrÃ¡lovÃ©, Czechia, 500 05 Institut Klinicke A Experimentalni MedicinyPrague, Czechia, 140 21 Nemocnice Na BulovcePrague, Czechia, 180 00 Fakultni Nemocnice V MotolePraha 5, Czechia, 150 06 Vseobecna Fakultni Nemocnice V PrazePraha, Czechia, 128 08 Nemocnice TrutnovTrutnov, Czechia, 541 01 Ormiga S.R.O.ZlÃ­n 1, Czechia, 760 01|Aalborg, Denmark, Dk-9000 Sydvestjysk Sygehus EsbjergEsbjerg, Denmark, Dk-6700 Regionshospitalet HerningHerning, Denmark, 7400 Hvidovre HospitalHvidovre, Denmark, 2650 Roskilde Sygehus - RoskildeRoskilde, Denmark, Dk-4000 Regionhospitalet ViborgViborg, Denmark, Dk-8800|Be'Er Sheva, Israel, 84101 Edith Wolfson Medical CenterHÌ±Olon, Israel, 58100 Hadassah Ein-Karem Medical CenterJerusalem, Israel, 91120 Rabin Medical Center - PpdsPetah Tikva, Israel, 4941492 Sheba Medical CenterRamat Gan, Israel, 52621 Ziv Medical CenterSafed, Israel, 1311001|Amersfoort, Netherlands, 3813 Tz Academisch Medisch Centrum AmsterdamAmsterdam, Netherlands, 1105 Az Ziekenhuis RijnstateArnhem, Netherlands, 6815 Ad HagaziekenhuisDen Haag, Netherlands, 2545 Aa Maxima Medisch CentrumEindhoven, Netherlands, 5631 Bm Martini ZiekenhuisGroningen, Netherlands, 9728 Nt Vasculair Onderzoek Centrum HoornHoorn, Netherlands, 1624 Np Admiraal De Ruyter ZiekenhuisTilburg, Netherlands, 5042 Ad Universitair Medisch Centrum UtrechtUtrecht, Netherlands, 3584 Cx Etz-TweestedenWaalwijk, Netherlands, 5141 Bm|Cape Town, Western Cape, South Africa, 7130|Bloemfontein, South Africa, 9301 Vergelegen Medi-ClinicCape Town, South Africa, 7130 Tread Research CcCape Town, South Africa, 7500 Tiervlei Trial CentreCape Town, South Africa, 7530 University Of Cape Town Medical SchoolCape Town, South Africa, 7925 Johannesburg HospitalJohannesburg, South Africa, 2193 Unitas HospitalPretoria, South Africa, 0157 Synexus Clinical Research SaPretoria, South Africa, 0184 Park Medical CentreWitbank, South Africa, 1035|A CoruÃ±a, Spain, 15006 Hospital Clinic De BarcelonaBarcelona, Spain C.H. Regional Reina SofiaCÃ³rdoba, Spain, 14004 Hospital Universitario De BellvitgeL'Hospitalet De Llobregat, Spain, 8907 Hospital Universitari Sant Joan De ReusReus, Spain, 43204 Hospital Universitario Miguel ServetZaragoza, Spain, 50009|GÃ¶teborg, Sweden, Se-41345 A+ Science AbStockholm, Sweden, Se-11157 Karolinska Universitetssjukhuset HuddingeStockholm, Sweden, Se-14186|Birmingham, United Kingdom, B9 5Ss Bristol Royal InfirmaryBristol, United Kingdom, Bs2 8Hw Royal Free HospitalLondon, United Kingdom, Nw3 2Qg Central Manchester University Hospitals Nhs Foundation TrustManchester, United Kingdom, M13 9Wl University Hospital Of South Manchester Nhs Foundation TrustManchester, United Kingdom, M23 9Lt The Newcastle Upon Tyne Hospitals Nhs Foundation TrustNewcastle, United Kingdom, Ne1 4Lp University Hospital LlandoughPenarth, United Kingdom, Cf642Xx Salford Royal HospitalSalford, United Kingdom, M6 8Hd Sandwell General HospitalWest Bromwich, United Kingdom, B71 4Hj|Fountain Valley, California, United States, 92708 St. Joseph Heritage HealthcareMission Viejo, California, United States, 92691 John Homan, MdNewport Beach, California, United States, 92663 Stanford UniversityStanford, California, United States, 94305|Boca Raton, Florida, United States, 33434|Oakbrook Terrace, Illinois, United States, 60181|Kansas City, Kansas, United States, 66160|Boston, Massachusetts, United States, 02114|Saint Paul, Minnesota, United States, 55102|Saint Louis, Missouri, United States, 63110|Butte, Montana, United States, 59701|Summit, New Jersey, United States, 07901|Charlotte, North Carolina, United States, 28207 Pmg Research Of Charlotte, LlcCharlotte, North Carolina, United States, 28209 Duke University Medical CenterDurham, North Carolina, United States, 27710|Cincinnati, Ohio, United States, 45227|Philadelphia, Pennsylvania, United States, 19104|Richmond, Virginia, United States, 23294|Renton, Washington, United States, 98057","California|Florida|Illinois|Kansas|Massachusetts|Minnesota|Missouri|Montana|New Jersey|North Carolina|Ohio|Pennsylvania|Virginia|Washington","Canada|Czechia|Denmark|Israel|Netherlands|South Africa|Spain|Sweden|United Kingdom|United States","Ontario The University Of Western Ontario Robarts Research Institute|Quebec Ecogene-21|Fakultni Nemocnice Hradec Kralove|Aalborg Universitetshospital|Soroka University Medical Centre|Meander Medisch Centrum|, Western Cape Helderberg Clinical Research Centre|Iatros International|Hospital Abente Y Lago|Sahlgrenska Universitetssjukhuset|Birmingham Heartlands Hospital|Orange Coast Medical Center|Excel Medical Clinical Trials, Llc|Advocate Health And Hospitals Corporation D/B/A Advocate Medical Group|University Of Kansas Medical Center|Massachusetts General Hospital|Healtheast Care System|Washington University School Of Medicine|Mercury Street Medical Group|Overlook Medical Center|Novant Health Heart And Vascular Institute|Metabolic And Atherosclerosis Research Center|University Of Pennsylvania|National Clinical Research, Inc.|Rainier Clinical Research Center, Inc.",{"$nulls":4},"2018-01-05","2020-05-25T16:36:22.766","2020-05-26T17:10:42.972","NCT03397121"]
["5ecbf406e2561b1b11905d24","NCT03397121","2018-01-12","The Medicines Company","MDCO","Recruiting","Trial to Evaluate the Effect of Inclisiran Treatment on Low Density Lipoprotein Cholesterol (LDL-C) in Subjects With Heterozygous Familial Hypercholesterolemia (HeFH) (ORION-9)","Inclisiran",null,"Yes","['Inclisiran']","Unknown",null,"Phase 3",2,400,"Anticipated","2017-11-28","2019-09-01",{"$nulls":5},"This is a Phase III, placebo-controlled, double-blind, randomized study in participants with HeFH and elevated LDL-C to evaluate the efficacy, safety, and tolerability of subcutaneous (SC) injection(s) of inclisiran. The study will be multicenter and international.",null,"Placebo-Controlled, Double-Blind, Randomized Trial to Evaluate the Effect of 300 mg of Inclisiran Sodium Given as Subcutaneous Injections in Subjects With Heterozygous Familial Hypercholesterolemia (HeFH) and Elevated Low-Density Lipoprotein Cholesterol (LDL-C).","MDCO-PCS-17-03","Heterozygous Familial Hypercholesterolemia\nElevated Cholesterol","Hypercholesterolemia","Metabolic Diseases","Nutritional Disorders","Experimental|Placebo Comparator","Inclisiran|Placebo","Inclisiran sodium 300 milligrams (mg) will be administered as a SC injection on Day 1, Day 90 then every 6 months.|Placebo will be administered as SC injections of saline solution on Day 1, Day 90 then every 6 months.","Drug","Inclisiran|Placebo","Inclisiran is a small interfering ribonucleic acid (RNA) that inhibits PCSK9 synthesis.|Placebo will be supplied as sterile normal saline (0.9% sodium chloride in water for injection).","Saline Solution","Inclisiran|Placebo","\n\nParticipants may be included if they meet all of the following inclusion criteria prior to randomization:\n\n 1. Male or female participants â‰¥18 years of age.\n 2. History of HeFH with a diagnosis of HeFH by genetic testing; and/or a documented history of untreated LDL-C of >190 mg/dL, and a family history of familial hypercholesterolemia, elevated cholesterol or early heart disease that may indicate familial hypercholesterolemia.\n 3. Serum LDL-C â‰¥2.6 millimoles (mmol)/liter (L) (â‰¥100 mg/dL) at screening.\n 4. Fasting triglyceride <4.52 mmol/L (<400 mg/dL) at screening.\n 5. Participants on statins should be receiving a maximally tolerated dose.\n 6. Participants not receiving statins must have documented evidence of intolerance to all doses of at least 2 different statins.\n 7. Participants on lipid-lowering therapies (such as a statin and/or ezetimibe) should be on a stable dose for â‰¥30 days before screening with no planned medication or dose change during study participation.\n\n","\n\nParticipants will be excluded from the study if any of the following exclusion criteria apply immediately prior to randomization:\n\n 1. New York Heart Association (NYHA) class IV heart failure.\n 2. Uncontrolled cardiac arrhythmia\n 3. Uncontrolled severe hypertension\n 4. Active liver disease\n 5. Females who are pregnant or nursing, or who are of childbearing potential and unwilling to use at least 2 methods of highly effective contraception (failure rate less than 1% per year) (combined oral contraceptives, barrier methods, approved contraceptive implant, long-term injectable contraception, or intrauterine device) for the entire duration of the study. Exemptions from this criterion: 1. Women >2 years postmenopausal (defined as 1 year or longer since last menstrual period) AND more than 55 years of age.\n     2. Postmenopausal women (as defined above) and less than 55 years of age with a negative pregnancy test within 24 hours of randomization.\n     3. Women who are surgically sterilized at least 3 months prior to enrollment.\n    \n    \n 6. Males who are unwilling to use an acceptable method of birth control during the entire study period (condom with spermicide).\n 7. Treatment with other investigational products or devices within 30 days or 5 half-lives of the screening visit, whichever is longer.\n 8. Treatment (within 90 days of screening) with monoclonal antibodies directed towards PCSK9.\n\nThe above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.",{"$nulls":4},"Actual","2018-01-11","Actual","Anticipated","2019-09-01","Anticipated","2018-01-01","2018-01-02","2018-01-05","2018-01-10","Yes","HeFH\nLDL-C\nInclisiran","Interventional","Treatment","Parallel Assignment","Double (Participant, Care Provider)","Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"2017-002472-30","EudraCT Number","Percentage Change In LDL-C from Baseline To Day 510|Time-adjusted Percentage Change In LDL-C From Baseline Between Day 90 And Day 540","Baseline, Day 510|Baseline, Day 90 to Day 540",null,"Absolute Change in LDL-C from Baseline to Day 510|Time-adjusted Absolute Change in LDL-C from Baseline Between Day 90 and Day 540|Percentage Change in Proprotein Convertase Subtilisin/kexin Type 9 (PCSK9) from Baseline to Day 510|Percentage Change in Total Cholesterol from Baseline to Day 510|Percentage Change in Apolipoprotein B (ApoB) from Baseline To Day 510|Percentage Change in Non-high-density Lipoprotein (HDL)-C from Baseline To Day 510","Baseline, Day 510|Baseline, Day 540",null,"medical.information@themedco.com","The Medicines Company Global Health Science Center","1-888-977-6326","London, Ontario, Canada, N6A 5B7|Chicoutimi, Quebec, Canada, G7H 7K9 Clinical Research Institute Of MontrealMontrÃ©al, Quebec, Canada, H2W 1R7 Royal Victoria HospitalMontrÃ©al, Quebec, Canada, H4A 3J1 Clinique Des Maladies Lipidiques De Quebec, Inc.Quebec City, Quebec, Canada, G1V 4W2 Centre Hospitalier Universitaire De Sherbrooke ChusSherbrooke, Quebec, Canada, J1H 5N4|Hradec KrÃ¡lovÃ©, Czechia, 500 05 Institut Klinicke A Experimentalni MedicinyPrague, Czechia, 140 21 Nemocnice Na BulovcePrague, Czechia, 180 00 Fakultni Nemocnice V MotolePraha 5, Czechia, 150 06 Vseobecna Fakultni Nemocnice V PrazePraha, Czechia, 128 08 Nemocnice TrutnovTrutnov, Czechia, 541 01 Ormiga S.R.O.ZlÃ­n 1, Czechia, 760 01|Aalborg, Denmark, Dk-9000 Sydvestjysk Sygehus EsbjergEsbjerg, Denmark, Dk-6700 Regionshospitalet HerningHerning, Denmark, 7400 Hvidovre HospitalHvidovre, Denmark, 2650 Roskilde Sygehus - RoskildeRoskilde, Denmark, Dk-4000 Regionhospitalet ViborgViborg, Denmark, Dk-8800|Be'Er Sheva, Israel, 84101 Edith Wolfson Medical CenterHÌ±Olon, Israel, 58100 Hadassah Ein-Karem Medical CenterJerusalem, Israel, 91120 Rabin Medical Center - PpdsPetah Tikva, Israel, 4941492 Sheba Medical CenterRamat Gan, Israel, 52621 Ziv Medical CenterSafed, Israel, 1311001|Amersfoort, Netherlands, 3813 Tz Academisch Medisch Centrum AmsterdamAmsterdam, Netherlands, 1105 Az Ziekenhuis RijnstateArnhem, Netherlands, 6815 Ad HagaziekenhuisDen Haag, Netherlands, 2545 Aa Maxima Medisch CentrumEindhoven, Netherlands, 5631 Bm Martini ZiekenhuisGroningen, Netherlands, 9728 Nt Vasculair Onderzoek Centrum HoornHoorn, Netherlands, 1624 Np Admiraal De Ruyter ZiekenhuisTilburg, Netherlands, 5042 Ad Universitair Medisch Centrum UtrechtUtrecht, Netherlands, 3584 Cx Etz-TweestedenWaalwijk, Netherlands, 5141 Bm|Cape Town, Western Cape, South Africa, 7130|Bloemfontein, South Africa, 9301 Vergelegen Medi-ClinicCape Town, South Africa, 7130 Tread Research CcCape Town, South Africa, 7500 Tiervlei Trial CentreCape Town, South Africa, 7530 University Of Cape Town Medical SchoolCape Town, South Africa, 7925 Johannesburg HospitalJohannesburg, South Africa, 2193 Unitas HospitalPretoria, South Africa, 0157 Synexus Clinical Research SaPretoria, South Africa, 0184 Park Medical CentreWitbank, South Africa, 1035|A CoruÃ±a, Spain, 15006 Hospital Clinic De BarcelonaBarcelona, Spain C.H. Regional Reina SofiaCÃ³rdoba, Spain, 14004 Hospital Universitario De BellvitgeL'Hospitalet De Llobregat, Spain, 8907 Hospital Universitari Sant Joan De ReusReus, Spain, 43204 Hospital Universitario Miguel ServetZaragoza, Spain, 50009|GÃ¶teborg, Sweden, Se-41345 A+ Science AbStockholm, Sweden, Se-11157 Karolinska Universitetssjukhuset HuddingeStockholm, Sweden, Se-14186|Birmingham, United Kingdom, B9 5Ss Bristol Royal InfirmaryBristol, United Kingdom, Bs2 8Hw Royal Free HospitalLondon, United Kingdom, Nw3 2Qg Central Manchester University Hospitals Nhs Foundation TrustManchester, United Kingdom, M13 9Wl University Hospital Of South Manchester Nhs Foundation TrustManchester, United Kingdom, M23 9Lt The Newcastle Upon Tyne Hospitals Nhs Foundation TrustNewcastle, United Kingdom, Ne1 4Lp University Hospital LlandoughPenarth, United Kingdom, Cf642Xx Salford Royal HospitalSalford, United Kingdom, M6 8Hd Sandwell General HospitalWest Bromwich, United Kingdom, B71 4Hj|Fountain Valley, California, United States, 92708 St. Joseph Heritage HealthcareMission Viejo, California, United States, 92691 John Homan, MdNewport Beach, California, United States, 92663 Stanford UniversityStanford, California, United States, 94305|Boca Raton, Florida, United States, 33434|Oakbrook Terrace, Illinois, United States, 60181|Kansas City, Kansas, United States, 66160|Boston, Massachusetts, United States, 02114|Saint Paul, Minnesota, United States, 55102|Saint Louis, Missouri, United States, 63110|Butte, Montana, United States, 59701|Summit, New Jersey, United States, 07901|Charlotte, North Carolina, United States, 28207 Pmg Research Of Charlotte, LlcCharlotte, North Carolina, United States, 28209 Duke University Medical CenterDurham, North Carolina, United States, 27710|Cincinnati, Ohio, United States, 45227|Philadelphia, Pennsylvania, United States, 19104|Richmond, Virginia, United States, 23294|Renton, Washington, United States, 98057","California|Florida|Illinois|Kansas|Massachusetts|Minnesota|Missouri|Montana|New Jersey|North Carolina|Ohio|Pennsylvania|Virginia|Washington","Canada|Czechia|Denmark|Israel|Netherlands|South Africa|Spain|Sweden|United Kingdom|United States","Ontario The University Of Western Ontario Robarts Research Institute|Quebec Ecogene-21|Fakultni Nemocnice Hradec Kralove|Aalborg Universitetshospital|Soroka University Medical Centre|Meander Medisch Centrum|, Western Cape Helderberg Clinical Research Centre|Iatros International|Hospital Abente Y Lago|Sahlgrenska Universitetssjukhuset|Birmingham Heartlands Hospital|Orange Coast Medical Center|Excel Medical Clinical Trials, Llc|Advocate Health And Hospitals Corporation D/B/A Advocate Medical Group|University Of Kansas Medical Center|Massachusetts General Hospital|Healtheast Care System|Washington University School Of Medicine|Mercury Street Medical Group|Overlook Medical Center|Novant Health Heart And Vascular Institute|Metabolic And Atherosclerosis Research Center|University Of Pennsylvania|National Clinical Research, Inc.|Rainier Clinical Research Center, Inc.",{"$nulls":4},"2018-01-10","2020-05-25T16:36:22.045","2020-05-26T17:10:42.972","NCT03397121"]
["5ecbf406fe30261b1a048229","NCT03397121","2018-04-09","The Medicines Company","MDCO","Active, not recruiting","Trial to Evaluate the Effect of Inclisiran Treatment on Low Density Lipoprotein Cholesterol (LDL-C) in Subjects With Heterozygous Familial Hypercholesterolemia (HeFH) (ORION-9)","Inclisiran",null,"Yes","['Inclisiran']","Unknown",null,"Phase 3",2,482,"Actual","2017-11-28","2019-09-01",{"$nulls":5},"This is a Phase III, placebo-controlled, double-blind, randomized study in participants with HeFH and elevated LDL-C to evaluate the efficacy, safety, and tolerability of subcutaneous (SC) injection(s) of inclisiran. The study will be multicenter and international.",null,"Placebo-Controlled, Double-Blind, Randomized Trial to Evaluate the Effect of 300 mg of Inclisiran Sodium Given as Subcutaneous Injections in Subjects With Heterozygous Familial Hypercholesterolemia (HeFH) and Elevated Low-Density Lipoprotein Cholesterol (LDL-C).","MDCO-PCS-17-03","Heterozygous Familial Hypercholesterolemia\nElevated Cholesterol","Hypercholesterolemia","Metabolic Diseases","Nutritional Disorders","Experimental|Placebo Comparator","Inclisiran|Placebo","Inclisiran sodium 300 milligrams (mg) will be administered as a SC injection on Day 1, Day 90 then every 6 months.|Placebo will be administered as SC injections of saline solution on Day 1, Day 90 then every 6 months.","Drug","Inclisiran|Placebo","Inclisiran is a small interfering ribonucleic acid (RNA) that inhibits PCSK9 synthesis.|Placebo will be supplied as sterile normal saline (0.9% sodium chloride in water for injection).","Saline Solution","Inclisiran|Placebo","\n\nParticipants may be included if they meet all of the following inclusion criteria prior to randomization:\n\n 1. Male or female participants â‰¥18 years of age.\n 2. History of HeFH with a diagnosis of HeFH by genetic testing; and/or a documented history of untreated LDL-C of >190 mg/dL, and a family history of familial hypercholesterolemia, elevated cholesterol or early heart disease that may indicate familial hypercholesterolemia.\n 3. Serum LDL-C â‰¥2.6 millimoles (mmol)/liter (L) (â‰¥100 mg/dL) at screening.\n 4. Fasting triglyceride <4.52 mmol/L (<400 mg/dL) at screening.\n 5. Participants on statins should be receiving a maximally tolerated dose.\n 6. Participants not receiving statins must have documented evidence of intolerance to all doses of at least 2 different statins.\n 7. Participants on lipid-lowering therapies (such as a statin and/or ezetimibe) should be on a stable dose for â‰¥30 days before screening with no planned medication or dose change during study participation.\n\n","\n\nParticipants will be excluded from the study if any of the following exclusion criteria apply immediately prior to randomization:\n\n 1. New York Heart Association (NYHA) class IV heart failure.\n 2. Uncontrolled cardiac arrhythmia\n 3. Uncontrolled severe hypertension\n 4. Active liver disease\n 5. Females who are pregnant or nursing, or who are of childbearing potential and unwilling to use at least 2 methods of highly effective contraception (failure rate less than 1% per year) (combined oral contraceptives, barrier methods, approved contraceptive implant, long-term injectable contraception, or intrauterine device) for the entire duration of the study. Exemptions from this criterion: 1. Women >2 years postmenopausal (defined as 1 year or longer since last menstrual period) AND more than 55 years of age.\n     2. Postmenopausal women (as defined above) and less than 55 years of age with a negative pregnancy test within 24 hours of randomization.\n     3. Women who are surgically sterilized at least 3 months prior to enrollment.\n    \n    \n 6. Males who are unwilling to use an acceptable method of birth control during the entire study period (condom with spermicide).\n 7. Treatment with other investigational products or devices within 30 days or 5 half-lives of the screening visit, whichever is longer.\n 8. Treatment (within 90 days of screening) with monoclonal antibodies directed towards PCSK9.\n\nThe above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.",{"$nulls":4},"Actual","2018-01-11","Actual","Anticipated","2019-09-01","Anticipated","2018-04-01","2018-01-02","2018-01-05","2018-04-06","Yes","HeFH\nLDL-C\nInclisiran","Interventional","Treatment","Parallel Assignment","Double (Participant, Care Provider)","Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"2017-002472-30","EudraCT Number","Percentage Change In LDL-C from Baseline To Day 510|Time-adjusted Percentage Change In LDL-C From Baseline Between Day 90 And Day 540","Baseline, Day 510|Baseline, Day 90 to Day 540",null,"Absolute Change in LDL-C from Baseline to Day 510|Time-adjusted Absolute Change in LDL-C from Baseline Between Day 90 and Day 540|Percentage Change in Proprotein Convertase Subtilisin/kexin Type 9 (PCSK9) from Baseline to Day 510|Percentage Change in Total Cholesterol from Baseline to Day 510|Percentage Change in Apolipoprotein B (ApoB) from Baseline To Day 510|Percentage Change in Non-high-density Lipoprotein (HDL)-C from Baseline To Day 510","Baseline, Day 510|Baseline, Day 540",{"$nulls":4},"Chicoutimi, Quebec, Canada, G7H 7K9 Clinical Research Institute Of MontrealMontrÃ©al, Quebec, Canada, H2W 1R7 Clinique Des Maladies Lipidiques De Quebec, Inc.Quebec City, Quebec, Canada, G1V 4W2|Prague, Czechia, 140 21 Nemocnice Na BulovcePrague, Czechia, 180 00 Nemocnice TrutnovTrutnov, Czechia, 541 01|Aalborg, Denmark, Dk-9000 Sydvestjysk Sygehus EsbjergEsbjerg, Denmark, Dk-6700 Regionshospitalet HerningHerning, Denmark, 7400 Hvidovre HospitalHvidovre, Denmark, 2650 Roskilde Sygehus - RoskildeRoskilde, Denmark, Dk-4000 Regionhospitalet ViborgViborg, Denmark, Dk-8800|Amersfoort, Netherlands, 3813 Tz Academisch Medisch Centrum AmsterdamAmsterdam, Netherlands, 1105 Az Vasculair Onderzoek Centrum HoornHoorn, Netherlands, 1624 Np Admiraal De Ruyter ZiekenhuisTilburg, Netherlands, 5042 Ad Universitair Medisch Centrum UtrechtUtrecht, Netherlands, 3584 Cx|Cape Town, Western Cape, South Africa, 7130|Bloemfontein, South Africa, 9301 Vergelegen Medi-ClinicCape Town, South Africa, 7130 Tread Research CcCape Town, South Africa, 7500 Tiervlei Trial CentreCape Town, South Africa, 7530 Johannesburg HospitalJohannesburg, South Africa, 2193 Unitas HospitalPretoria, South Africa, 0157 Synexus Clinical Research SaPretoria, South Africa, 0184 Park Medical CentreWitbank, South Africa, 1035|A CoruÃ±a, Spain, 15006 Hospital Clinic De BarcelonaBarcelona, Spain C.H. Regional Reina SofiaCÃ³rdoba, Spain, 14004 Hospital Universitario De BellvitgeL'Hospitalet De Llobregat, Spain, 8907 Hospital Universitari Sant Joan De ReusReus, Spain, 43204 Hospital Universitario Miguel ServetZaragoza, Spain, 50009|GÃ¶teborg, Sweden, Se-41345 A+ Science AbStockholm, Sweden, Se-11157 Karolinska Universitetssjukhuset HuddingeStockholm, Sweden, Se-14186|Mission Viejo, California, United States, 92691 John Homan, MdNewport Beach, California, United States, 92663 Stanford UniversityStanford, California, United States, 94305|Boca Raton, Florida, United States, 33434|Calhoun, Georgia, United States, 30701|Boston, Massachusetts, United States, 02114|Saint Paul, Minnesota, United States, 55102|Butte, Montana, United States, 59701|Las Vegas, Nevada, United States, 89119|Summit, New Jersey, United States, 07901|Cincinnati, Ohio, United States, 45227","California|Florida|Georgia|Massachusetts|Minnesota|Montana|Nevada|New Jersey|Ohio","Canada|Czechia|Denmark|Netherlands|South Africa|Spain|Sweden|United States","Quebec Ecogene-21|Institut Klinicke A Experimentalni Mediciny|Aalborg Universitetshospital|Meander Medisch Centrum|, Western Cape Helderberg Clinical Research Centre|Iatros International|Hospital Abente Y Lago|Sahlgrenska Universitetssjukhuset|St. Joseph Heritage Healthcare|Excel Medical Clinical Trials, Llc|Global Research Partners And Consultants Inc|Massachusetts General Hospital|Healtheast Care System|Mercury Street Medical Group|Ab Clinical Trials|Overlook Medical Center|Metabolic And Atherosclerosis Research Center",{"$nulls":4},"2018-04-06","2020-05-25T16:36:22.072","2020-05-26T17:10:42.972","NCT03397121"]
["5ecbf40611702c1b1b916a3a","NCT03397121","2018-12-21","The Medicines Company","MDCO","Active, not recruiting","Trial to Evaluate the Effect of Inclisiran Treatment on Low Density Lipoprotein Cholesterol (LDL-C) in Subjects With Heterozygous Familial Hypercholesterolemia (HeFH) (ORION-9)","Inclisiran",null,"Yes","['Inclisiran']","Unknown",null,"Phase 3",2,482,"Actual","2017-11-28","2019-09-01",{"$nulls":5},"This is a Phase III, placebo-controlled, double-blind, randomized study in participants with HeFH and elevated LDL-C to evaluate the efficacy, safety, and tolerability of subcutaneous (SC) injection(s) of inclisiran. The study will be multicenter and international.",null,"Placebo-Controlled, Double-Blind, Randomized Trial to Evaluate the Effect of 300 mg of Inclisiran Sodium Given as Subcutaneous Injections in Subjects With Heterozygous Familial Hypercholesterolemia (HeFH) and Elevated Low-Density Lipoprotein Cholesterol (LDL-C).","MDCO-PCS-17-03","Heterozygous Familial Hypercholesterolemia\nElevated Cholesterol","Hypercholesterolemia","Metabolic Diseases","Nutritional Disorders","Experimental|Placebo Comparator","Inclisiran|Placebo","Inclisiran sodium 300 milligrams (mg) will be administered as a SC injection on Day 1, Day 90 then every 6 months.|Placebo will be administered as SC injections of saline solution on Day 1, Day 90 then every 6 months.","Drug","Inclisiran|Placebo","Inclisiran is a small interfering ribonucleic acid (RNA) that inhibits PCSK9 synthesis.|Placebo will be supplied as sterile normal saline (0.9% sodium chloride in water for injection).","Saline Solution","Inclisiran|Placebo","\n\nParticipants may be included if they meet all of the following inclusion criteria prior to randomization:\n\n 1. Male or female participants â‰¥18 years of age.\n 2. History of HeFH with a diagnosis of HeFH by genetic testing; and/or a documented history of untreated LDL-C of >190 mg/dL, and a family history of familial hypercholesterolemia, elevated cholesterol or early heart disease that may indicate familial hypercholesterolemia.\n 3. Serum LDL-C â‰¥2.6 millimoles (mmol)/liter (L) (â‰¥100 mg/dL) at screening.\n 4. Fasting triglyceride <4.52 mmol/L (<400 mg/dL) at screening.\n 5. Participants on statins should be receiving a maximally tolerated dose.\n 6. Participants not receiving statins must have documented evidence of intolerance to all doses of at least 2 different statins.\n 7. Participants on lipid-lowering therapies (such as a statin and/or ezetimibe) should be on a stable dose for â‰¥30 days before screening with no planned medication or dose change during study participation.\n\n","\n\nParticipants will be excluded from the study if any of the following exclusion criteria apply immediately prior to randomization:\n\n 1. New York Heart Association (NYHA) class IV heart failure.\n 2. Uncontrolled cardiac arrhythmia\n 3. Uncontrolled severe hypertension\n 4. Active liver disease\n 5. Females who are pregnant or nursing, or who are of childbearing potential and unwilling to use at least 2 methods of highly effective contraception (failure rate less than 1% per year) (combined oral contraceptives, barrier methods, approved contraceptive implant, long-term injectable contraception, or intrauterine device) for the entire duration of the study. Exemptions from this criterion: 1. Women >2 years postmenopausal (defined as 1 year or longer since last menstrual period) AND more than 55 years of age.\n     2. Postmenopausal women (as defined above) and less than 55 years of age with a negative pregnancy test within 24 hours of randomization.\n     3. Women who are surgically sterilized at least 3 months prior to enrollment.\n    \n    \n 6. Males who are unwilling to use an acceptable method of birth control during the entire study period (condom with spermicide).\n 7. Treatment with other investigational products or devices within 30 days or 5 half-lives of the screening visit, whichever is longer.\n 8. Treatment (within 90 days of screening) with monoclonal antibodies directed towards PCSK9.\n\nThe above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.",{"$nulls":4},"Actual","2018-01-11","Actual","Anticipated","2019-09-01","Anticipated","2018-12-01","2018-01-02","2018-01-05","2018-12-20","Yes","HeFH\nLDL-C\nInclisiran","Interventional","Treatment","Parallel Assignment","Double (Participant, Care Provider)","Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"2017-002472-30","EudraCT Number","Percentage Change In LDL-C from Baseline To Day 510|Time-adjusted Percentage Change In LDL-C From Baseline Between Day 90 And Day 540","Baseline, Day 510|Baseline, Day 90 to Day 540",null,"Absolute Change in LDL-C from Baseline to Day 510|Time-adjusted Absolute Change in LDL-C from Baseline Between Day 90 and Day 540|Percentage Change in Proprotein Convertase Subtilisin/kexin Type 9 (PCSK9) from Baseline to Day 510|Percentage Change in Total Cholesterol from Baseline to Day 510|Percentage Change in Apolipoprotein B (ApoB) from Baseline To Day 510|Percentage Change in Non-high-density Lipoprotein (HDL)-C from Baseline To Day 510","Baseline, Day 510|Baseline, Day 540",{"$nulls":4},"Chicoutimi, Quebec, Canada, G7H 7K9 Site 90011-001MontrÃ©al, Quebec, Canada, H2W 1R7 Site 90011-002Quebec City, Quebec, Canada, G1V 4W2|Prague, Czechia, 140 21 Site 90420-006Prague, Czechia, 180 00 Site 90420-005Trutnov, Czechia, 541 01|Aalborg, Denmark, Dk-9000 Site 90045-004Esbjerg, Denmark, Dk-6700 Site 90045-003Herning, Denmark, 7400 Site 90045-006Hvidovre, Denmark, 2650 Site 90045-002Roskilde, Denmark, Dk-4000 90045-005Viborg, Denmark, Dk-8800|Amersfoort, Netherlands, 3813 Tz Site 90031-003Amsterdam, Netherlands, 1105 Az Site 90031-009Hoorn, Netherlands, 1624 Np Site 90031-006Tilburg, Netherlands, 5042 Ad Site 90031-005Utrecht, Netherlands, 3584 Cx|Cape Town, Western Cape, South Africa, 7130|Bloemfontein, South Africa, 9301 Site 90027-005Cape Town, South Africa, 7130 Site 90027-001Cape Town, South Africa, 7500 Site 90027-008Cape Town, South Africa, 7530 Site 90027-010Johannesburg, South Africa, 2193 Site 90027-007Pretoria, South Africa, 0157 Site 90027-006Pretoria, South Africa, 0184 Site 90027-009Witbank, South Africa, 1035|A CoruÃ±a, Spain, 15006 Site 90034-005Barcelona, Spain Site 90034-004CÃ³rdoba, Spain, 14004 Site 90034-006L'Hospitalet De Llobregat, Spain, 8907 Site 90034-001Reus, Spain, 43204 Site 90034-002Zaragoza, Spain, 50009|GÃ¶teborg, Sweden, Se-41345 Site 90046-001Stockholm, Sweden, Se-11157 Site 90046-003Stockholm, Sweden, Se-14186|Mission Viejo, California, United States, 92691 Site 90001-001Newport Beach, California, United States, 92663 Site 90001-015Stanford, California, United States, 94305|Boca Raton, Florida, United States, 33434|Boston, Massachusetts, United States, 02114|Saint Paul, Minnesota, United States, 55102|Butte, Montana, United States, 59701|Las Vegas, Nevada, United States, 89119|Summit, New Jersey, United States, 07901|Cincinnati, Ohio, United States, 45227","California|Florida|Massachusetts|Minnesota|Montana|Nevada|New Jersey|Ohio","Canada|Czechia|Denmark|Netherlands|South Africa|Spain|Sweden|United States","Quebec Site 90011-005|Site 90420-001|Site 90045-001|Site 90031-001|, Western Cape Site 90027-004|Site 90027-003|Site 90034-003|Site 90046-002|Site 90001-005|Site 90001-047|Site 90001-004|Site 90001-056|Site 90001-012|Site 90001-112|Site 90001-014|Site 90001-002",{"$nulls":4},"2018-12-20","2020-05-25T16:36:22.156","2020-05-26T17:10:42.972","NCT03397121"]
["5ecbf406307e3d1b1f8d9cba","NCT03397121","2019-04-17","The Medicines Company","MDCO","Active, not recruiting","Trial to Evaluate the Effect of Inclisiran Treatment on Low Density Lipoprotein Cholesterol (LDL-C) in Subjects With Heterozygous Familial Hypercholesterolemia (HeFH) (ORION-9)","Inclisiran",null,"Yes","['Inclisiran']","Unknown",null,"Phase 3",2,482,"Actual","2017-11-28","2019-09-01",{"$nulls":5},"This is a Phase III, placebo-controlled, double-blind, randomized study in participants with HeFH and elevated LDL-C to evaluate the efficacy, safety, and tolerability of subcutaneous (SC) injection(s) of inclisiran. The study will be multicenter and international.",null,"Placebo-Controlled, Double-Blind, Randomized Trial to Evaluate the Effect of 300 mg of Inclisiran Sodium Given as Subcutaneous Injections in Subjects With Heterozygous Familial Hypercholesterolemia (HeFH) and Elevated Low-Density Lipoprotein Cholesterol (LDL-C).","MDCO-PCS-17-03","Heterozygous Familial Hypercholesterolemia\nElevated Cholesterol","Hypercholesterolemia","Metabolic Diseases","Nutritional Disorders","Experimental|Placebo Comparator","Inclisiran|Placebo","Inclisiran sodium 300 milligrams (mg) will be administered as a SC injection on Day 1, Day 90 then every 6 months.|Placebo will be administered as SC injections of saline solution on Day 1, Day 90 then every 6 months.","Drug","Inclisiran|Placebo","Inclisiran is a small interfering ribonucleic acid (RNA) that inhibits PCSK9 synthesis.|Placebo will be supplied as sterile normal saline (0.9% sodium chloride in water for injection).","Saline Solution","Inclisiran|Placebo","\n\nParticipants may be included if they meet all of the following inclusion criteria prior to randomization:\n\n 1. Male or female participants â‰¥18 years of age.\n 2. History of HeFH with a diagnosis of HeFH by genetic testing; and/or a documented history of untreated LDL-C of >190 mg/dL, and a family history of familial hypercholesterolemia, elevated cholesterol or early heart disease that may indicate familial hypercholesterolemia.\n 3. Serum LDL-C â‰¥2.6 millimoles (mmol)/liter (L) (â‰¥100 mg/dL) at screening.\n 4. Fasting triglyceride <4.52 mmol/L (<400 mg/dL) at screening.\n 5. Participants on statins should be receiving a maximally tolerated dose.\n 6. Participants not receiving statins must have documented evidence of intolerance to all doses of at least 2 different statins.\n 7. Participants on lipid-lowering therapies (such as a statin and/or ezetimibe) should be on a stable dose for â‰¥30 days before screening with no planned medication or dose change during study participation.\n\n","\n\nParticipants will be excluded from the study if any of the following exclusion criteria apply immediately prior to randomization:\n\n 1. New York Heart Association (NYHA) class IV heart failure.\n 2. Uncontrolled cardiac arrhythmia\n 3. Uncontrolled severe hypertension\n 4. Active liver disease\n 5. Females who are pregnant or nursing, or who are of childbearing potential and unwilling to use at least 2 methods of highly effective contraception (failure rate less than 1% per year) (combined oral contraceptives, barrier methods, approved contraceptive implant, long-term injectable contraception, or intrauterine device) for the entire duration of the study. Exemptions from this criterion: 1. Women >2 years postmenopausal (defined as 1 year or longer since last menstrual period) AND more than 55 years of age.\n     2. Postmenopausal women (as defined above) and less than 55 years of age with a negative pregnancy test within 24 hours of randomization.\n     3. Women who are surgically sterilized at least 3 months prior to enrollment.\n    \n    \n 6. Males who are unwilling to use an acceptable method of birth control during the entire study period (condom with spermicide).\n 7. Treatment with other investigational products or devices within 30 days or 5 half-lives of the screening visit, whichever is longer.\n 8. Treatment (within 90 days of screening) with monoclonal antibodies directed towards PCSK9.\n\nThe above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.",{"$nulls":4},"Actual","2018-01-11","Actual","Anticipated","2019-09-01","Anticipated","2019-04-01","2018-01-02","2018-01-05","2019-04-15","Yes","HeFH\nLDL-C\nInclisiran","Interventional","Treatment","Parallel Assignment","Double (Participant, Care Provider)","Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"2017-002472-30","EudraCT Number","Percentage Change In LDL-C from Baseline To Day 510|Time-adjusted Percentage Change in LDL-C from Baseline After Day 90 and up to Day 540 Levels","Baseline, Day 510|Baseline, Day 90 to Day 540",null,"Absolute Change in LDL-C from Baseline to Day 510|Time-adjusted Absolute Change in LDL-C from Baseline After Day 90 and up to Day 540|Percentage Change in Proprotein Convertase Subtilisin/kexin Type 9 (PCSK9) from Baseline to Day 510|Percentage Change in Total Cholesterol from Baseline to Day 510|Percentage Change in Apolipoprotein B (ApoB) from Baseline To Day 510|Percentage Change in Non-high-density Lipoprotein (HDL)-C from Baseline To Day 510","Baseline, Day 510|Baseline, Day 540",{"$nulls":4},"Chicoutimi, Quebec, Canada, G7H 7K9 Site 90011-001MontrÃ©al, Quebec, Canada, H2W 1R7 Site 90011-002Quebec City, Quebec, Canada, G1V 4W2|Prague, Czechia, 140 21 Site 90420-006Prague, Czechia, 180 00 Site 90420-005Trutnov, Czechia, 541 01|Aalborg, Denmark, Dk-9000 Site 90045-004Esbjerg, Denmark, Dk-6700 Site 90045-003Herning, Denmark, 7400 Site 90045-006Hvidovre, Denmark, 2650 Site 90045-002Roskilde, Denmark, Dk-4000 90045-005Viborg, Denmark, Dk-8800|Amersfoort, Netherlands, 3813 Tz Site 90031-003Amsterdam, Netherlands, 1105 Az Site 90031-009Hoorn, Netherlands, 1624 Np Site 90031-006Tilburg, Netherlands, 5042 Ad Site 90031-005Utrecht, Netherlands, 3584 Cx|Cape Town, Western Cape, South Africa, 7130|Bloemfontein, South Africa, 9301 Site 90027-005Cape Town, South Africa, 7130 Site 90027-001Cape Town, South Africa, 7500 Site 90027-008Cape Town, South Africa, 7530 Site 90027-010Johannesburg, South Africa, 2193 Site 90027-007Pretoria, South Africa, 0157 Site 90027-006Pretoria, South Africa, 0184 Site 90027-009Witbank, South Africa, 1035|A CoruÃ±a, Spain, 15006 Site 90034-005Barcelona, Spain Site 90034-004CÃ³rdoba, Spain, 14004 Site 90034-006L'Hospitalet De Llobregat, Spain, 8907 Site 90034-001Reus, Spain, 43204 Site 90034-002Zaragoza, Spain, 50009|GÃ¶teborg, Sweden, Se-41345 Site 90046-001Stockholm, Sweden, Se-11157 Site 90046-003Stockholm, Sweden, Se-14186|Mission Viejo, California, United States, 92691 Site 90001-001Newport Beach, California, United States, 92663 Site 90001-015Stanford, California, United States, 94305|Boca Raton, Florida, United States, 33434|Boston, Massachusetts, United States, 02114|Saint Paul, Minnesota, United States, 55102|Butte, Montana, United States, 59701|Las Vegas, Nevada, United States, 89119|Summit, New Jersey, United States, 07901|Cincinnati, Ohio, United States, 45227","California|Florida|Massachusetts|Minnesota|Montana|Nevada|New Jersey|Ohio","Canada|Czechia|Denmark|Netherlands|South Africa|Spain|Sweden|United States","Quebec Site 90011-005|Site 90420-001|Site 90045-001|Site 90031-001|, Western Cape Site 90027-004|Site 90027-003|Site 90034-003|Site 90046-002|Site 90001-005|Site 90001-047|Site 90001-004|Site 90001-056|Site 90001-012|Site 90001-112|Site 90001-014|Site 90001-002",{"$nulls":4},"2019-04-15","2020-05-25T16:36:22.133","2020-05-26T17:10:42.972","NCT03397121"]
["5ecbf406e2561b1b11905d25","NCT03397121","2019-09-10","The Medicines Company","MDCO","Completed","Trial to Evaluate the Effect of Inclisiran Treatment on Low Density Lipoprotein Cholesterol (LDL-C) in Subjects With Heterozygous Familial Hypercholesterolemia (HeFH) (ORION-9)","Inclisiran",null,"Yes","['Inclisiran']","Unknown",null,"Phase 3",2,482,"Actual","2017-11-28","2019-08-27",{"$nulls":5},"This is a Phase III, placebo-controlled, double-blind, randomized study in participants with HeFH and elevated LDL-C to evaluate the efficacy, safety, and tolerability of subcutaneous (SC) injection(s) of inclisiran. The study will be multicenter and international.",null,"Placebo-Controlled, Double-Blind, Randomized Trial to Evaluate the Effect of 300 mg of Inclisiran Sodium Given as Subcutaneous Injections in Subjects With Heterozygous Familial Hypercholesterolemia (HeFH) and Elevated Low-Density Lipoprotein Cholesterol (LDL-C).","MDCO-PCS-17-03","Heterozygous Familial Hypercholesterolemia\nElevated Cholesterol","Hypercholesterolemia","Metabolic Diseases","Nutritional Disorders","Experimental|Placebo Comparator","Inclisiran|Placebo","Inclisiran sodium 300 milligrams (mg) will be administered as a SC injection on Day 1, Day 90 then every 6 months.|Placebo will be administered as SC injections of saline solution on Day 1, Day 90 then every 6 months.","Drug","Inclisiran|Placebo","Inclisiran is a small interfering ribonucleic acid (RNA) that inhibits PCSK9 synthesis.|Placebo will be supplied as sterile normal saline (0.9% sodium chloride in water for injection).","Saline Solution","Inclisiran|Placebo","\n\nParticipants may be included if they meet all of the following inclusion criteria prior to randomization:\n\n 1. Male or female participants â‰¥18 years of age.\n 2. History of HeFH with a diagnosis of HeFH by genetic testing; and/or a documented history of untreated LDL-C of >190 mg/dL, and a family history of familial hypercholesterolemia, elevated cholesterol or early heart disease that may indicate familial hypercholesterolemia.\n 3. Serum LDL-C â‰¥2.6 millimoles (mmol)/liter (L) (â‰¥100 mg/dL) at screening.\n 4. Fasting triglyceride <4.52 mmol/L (<400 mg/dL) at screening.\n 5. Participants on statins should be receiving a maximally tolerated dose.\n 6. Participants not receiving statins must have documented evidence of intolerance to all doses of at least 2 different statins.\n 7. Participants on lipid-lowering therapies (such as a statin and/or ezetimibe) should be on a stable dose for â‰¥30 days before screening with no planned medication or dose change during study participation.\n\n","\n\nParticipants will be excluded from the study if any of the following exclusion criteria apply immediately prior to randomization:\n\n 1. New York Heart Association (NYHA) class IV heart failure.\n 2. Uncontrolled cardiac arrhythmia\n 3. Uncontrolled severe hypertension\n 4. Active liver disease\n 5. Females who are pregnant or nursing, or who are of childbearing potential and unwilling to use at least 2 methods of highly effective contraception (failure rate less than 1% per year) (combined oral contraceptives, barrier methods, approved contraceptive implant, long-term injectable contraception, or intrauterine device) for the entire duration of the study. Exemptions from this criterion: 1. Women >2 years postmenopausal (defined as 1 year or longer since last menstrual period) AND more than 55 years of age.\n     2. Postmenopausal women (as defined above) and less than 55 years of age with a negative pregnancy test within 24 hours of randomization.\n     3. Women who are surgically sterilized at least 3 months prior to enrollment.\n    \n    \n 6. Males who are unwilling to use an acceptable method of birth control during the entire study period (condom with spermicide).\n 7. Treatment with other investigational products or devices within 30 days or 5 half-lives of the screening visit, whichever is longer.\n 8. Treatment (within 90 days of screening) with monoclonal antibodies directed towards PCSK9.\n\nThe above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.",{"$nulls":4},"Actual","2018-01-11","Actual","Actual","2019-08-27","Actual","2019-09-01","2018-01-02","2018-01-05","2019-09-09","Yes","HeFH\nLDL-C\nInclisiran","Interventional","Treatment","Parallel Assignment","Double (Participant, Care Provider)","Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"2017-002472-30","EudraCT Number","Percentage Change In LDL-C from Baseline To Day 510|Time-adjusted Percentage Change in LDL-C from Baseline After Day 90 and up to Day 540 Levels","Baseline, Day 510|Baseline, Day 90 to Day 540",null,"Absolute Change in LDL-C from Baseline to Day 510|Time-adjusted Absolute Change in LDL-C from Baseline After Day 90 and up to Day 540|Percentage Change in Proprotein Convertase Subtilisin/kexin Type 9 (PCSK9) from Baseline to Day 510|Percentage Change in Total Cholesterol from Baseline to Day 510|Percentage Change in Apolipoprotein B (ApoB) from Baseline To Day 510|Percentage Change in Non-high-density Lipoprotein (HDL)-C from Baseline To Day 510","Baseline, Day 510|Baseline, Day 540",{"$nulls":4},"Chicoutimi, Quebec, Canada, G7H 7K9 Site 90011-001MontrÃ©al, Quebec, Canada, H2W 1R7 Site 90011-002Quebec City, Quebec, Canada, G1V 4W2|Prague, Czechia, 140 21 Site 90420-006Prague, Czechia, 180 00 Site 90420-005Trutnov, Czechia, 541 01|Aalborg, Denmark, Dk-9000 Site 90045-004Esbjerg, Denmark, Dk-6700 Site 90045-003Herning, Denmark, 7400 Site 90045-006Hvidovre, Denmark, 2650 Site 90045-002Roskilde, Denmark, Dk-4000 90045-005Viborg, Denmark, Dk-8800|Amersfoort, Netherlands, 3813 Tz Site 90031-003Amsterdam, Netherlands, 1105 Az Site 90031-009Hoorn, Netherlands, 1624 Np Site 90031-006Tilburg, Netherlands, 5042 Ad Site 90031-005Utrecht, Netherlands, 3584 Cx|Cape Town, Western Cape, South Africa, 7130|Bloemfontein, South Africa, 9301 Site 90027-005Cape Town, South Africa, 7130 Site 90027-001Cape Town, South Africa, 7500 Site 90027-008Cape Town, South Africa, 7530 Site 90027-010Johannesburg, South Africa, 2193 Site 90027-007Pretoria, South Africa, 0157 Site 90027-006Pretoria, South Africa, 0184 Site 90027-009Witbank, South Africa, 1035|A CoruÃ±a, Spain, 15006 Site 90034-005Barcelona, Spain Site 90034-004CÃ³rdoba, Spain, 14004 Site 90034-006L'Hospitalet De Llobregat, Spain, 8907 Site 90034-001Reus, Spain, 43204 Site 90034-002Zaragoza, Spain, 50009|GÃ¶teborg, Sweden, Se-41345 Site 90046-001Stockholm, Sweden, Se-11157 Site 90046-003Stockholm, Sweden, Se-14186|Mission Viejo, California, United States, 92691 Site 90001-001Newport Beach, California, United States, 92663 Site 90001-015Stanford, California, United States, 94305|Boca Raton, Florida, United States, 33434|Boston, Massachusetts, United States, 02114|Saint Paul, Minnesota, United States, 55102|Butte, Montana, United States, 59701|Las Vegas, Nevada, United States, 89119|Summit, New Jersey, United States, 07901|Cincinnati, Ohio, United States, 45227","California|Florida|Massachusetts|Minnesota|Montana|Nevada|New Jersey|Ohio","Canada|Czechia|Denmark|Netherlands|South Africa|Spain|Sweden|United States","Quebec Site 90011-005|Site 90420-001|Site 90045-001|Site 90031-001|, Western Cape Site 90027-004|Site 90027-003|Site 90034-003|Site 90046-002|Site 90001-005|Site 90001-047|Site 90001-004|Site 90001-056|Site 90001-012|Site 90001-112|Site 90001-014|Site 90001-002",{"$nulls":4},"2019-09-09","2020-05-25T16:36:22.448","2020-05-26T17:10:42.972","NCT03397121"]
["5ecbf406fe30261b1a04822a","NCT03397121","2019-09-17","The Medicines Company","MDCO","Active, not recruiting","Trial to Evaluate the Effect of Inclisiran Treatment on Low Density Lipoprotein Cholesterol (LDL-C) in Subjects With Heterozygous Familial Hypercholesterolemia (HeFH) (ORION-9)","Inclisiran",null,"Yes","['Inclisiran']","Unknown",null,"Phase 3",2,482,"Actual","2017-11-28","2019-09-27",{"$nulls":5},"This is a Phase III, placebo-controlled, double-blind, randomized study in participants with HeFH and elevated LDL-C to evaluate the efficacy, safety, and tolerability of subcutaneous (SC) injection(s) of inclisiran. The study will be multicenter and international.",null,"Placebo-Controlled, Double-Blind, Randomized Trial to Evaluate the Effect of 300 mg of Inclisiran Sodium Given as Subcutaneous Injections in Subjects With Heterozygous Familial Hypercholesterolemia (HeFH) and Elevated Low-Density Lipoprotein Cholesterol (LDL-C).","MDCO-PCS-17-03","Heterozygous Familial Hypercholesterolemia\nElevated Cholesterol","Hypercholesterolemia","Metabolic Diseases","Nutritional Disorders","Experimental|Placebo Comparator","Inclisiran|Placebo","Inclisiran sodium 300 milligrams (mg) will be administered as a SC injection on Day 1, Day 90 then every 6 months.|Placebo will be administered as SC injections of saline solution on Day 1, Day 90 then every 6 months.","Drug","Inclisiran|Placebo","Inclisiran is a small interfering ribonucleic acid (RNA) that inhibits PCSK9 synthesis.|Placebo will be supplied as sterile normal saline (0.9% sodium chloride in water for injection).","Saline Solution","Inclisiran|Placebo","\n\nParticipants may be included if they meet all of the following inclusion criteria prior to randomization:\n\n 1. Male or female participants â‰¥18 years of age.\n 2. History of HeFH with a diagnosis of HeFH by genetic testing; and/or a documented history of untreated LDL-C of >190 mg/dL, and a family history of familial hypercholesterolemia, elevated cholesterol or early heart disease that may indicate familial hypercholesterolemia.\n 3. Serum LDL-C â‰¥2.6 millimoles (mmol)/liter (L) (â‰¥100 mg/dL) at screening.\n 4. Fasting triglyceride <4.52 mmol/L (<400 mg/dL) at screening.\n 5. Participants on statins should be receiving a maximally tolerated dose.\n 6. Participants not receiving statins must have documented evidence of intolerance to all doses of at least 2 different statins.\n 7. Participants on lipid-lowering therapies (such as a statin and/or ezetimibe) should be on a stable dose for â‰¥30 days before screening with no planned medication or dose change during study participation.\n\n","\n\nParticipants will be excluded from the study if any of the following exclusion criteria apply immediately prior to randomization:\n\n 1. New York Heart Association (NYHA) class IV heart failure.\n 2. Uncontrolled cardiac arrhythmia\n 3. Uncontrolled severe hypertension\n 4. Active liver disease\n 5. Females who are pregnant or nursing, or who are of childbearing potential and unwilling to use at least 2 methods of highly effective contraception (failure rate less than 1% per year) (combined oral contraceptives, barrier methods, approved contraceptive implant, long-term injectable contraception, or intrauterine device) for the entire duration of the study. Exemptions from this criterion: 1. Women >2 years postmenopausal (defined as 1 year or longer since last menstrual period) AND more than 55 years of age.\n     2. Postmenopausal women (as defined above) and less than 55 years of age with a negative pregnancy test within 24 hours of randomization.\n     3. Women who are surgically sterilized at least 3 months prior to enrollment.\n    \n    \n 6. Males who are unwilling to use an acceptable method of birth control during the entire study period (condom with spermicide).\n 7. Treatment with other investigational products or devices within 30 days or 5 half-lives of the screening visit, whichever is longer.\n 8. Treatment (within 90 days of screening) with monoclonal antibodies directed towards PCSK9.\n\nThe above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.",{"$nulls":4},"Actual","2018-01-11","Actual","Anticipated","2019-09-27","Anticipated","2019-09-01","2018-01-02","2018-01-05","2019-09-16","Yes","HeFH\nLDL-C\nInclisiran","Interventional","Treatment","Parallel Assignment","Double (Participant, Care Provider)","Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"2017-002472-30","EudraCT Number","Percentage Change In LDL-C from Baseline To Day 510|Time-adjusted Percentage Change in LDL-C from Baseline After Day 90 and up to Day 540 Levels","Baseline, Day 510|Baseline, Day 90 to Day 540",null,"Absolute Change in LDL-C from Baseline to Day 510|Time-adjusted Absolute Change in LDL-C from Baseline After Day 90 and up to Day 540|Percentage Change in Proprotein Convertase Subtilisin/kexin Type 9 (PCSK9) from Baseline to Day 510|Percentage Change in Total Cholesterol from Baseline to Day 510|Percentage Change in Apolipoprotein B (ApoB) from Baseline To Day 510|Percentage Change in Non-high-density Lipoprotein (HDL)-C from Baseline To Day 510","Baseline, Day 510|Baseline, Day 540",{"$nulls":4},"Chicoutimi, Quebec, Canada, G7H 7K9 Site 90011-001MontrÃ©al, Quebec, Canada, H2W 1R7 Site 90011-002Quebec City, Quebec, Canada, G1V 4W2|Prague, Czechia, 140 21 Site 90420-006Prague, Czechia, 180 00 Site 90420-005Trutnov, Czechia, 541 01|Aalborg, Denmark, Dk-9000 Site 90045-004Esbjerg, Denmark, Dk-6700 Site 90045-003Herning, Denmark, 7400 Site 90045-006Hvidovre, Denmark, 2650 Site 90045-002Roskilde, Denmark, Dk-4000 90045-005Viborg, Denmark, Dk-8800|Amersfoort, Netherlands, 3813 Tz Site 90031-003Amsterdam, Netherlands, 1105 Az Site 90031-009Hoorn, Netherlands, 1624 Np Site 90031-006Tilburg, Netherlands, 5042 Ad Site 90031-005Utrecht, Netherlands, 3584 Cx|Cape Town, Western Cape, South Africa, 7130|Bloemfontein, South Africa, 9301 Site 90027-005Cape Town, South Africa, 7130 Site 90027-001Cape Town, South Africa, 7500 Site 90027-008Cape Town, South Africa, 7530 Site 90027-010Johannesburg, South Africa, 2193 Site 90027-007Pretoria, South Africa, 0157 Site 90027-006Pretoria, South Africa, 0184 Site 90027-009Witbank, South Africa, 1035|A CoruÃ±a, Spain, 15006 Site 90034-005Barcelona, Spain Site 90034-004CÃ³rdoba, Spain, 14004 Site 90034-006L'Hospitalet De Llobregat, Spain, 8907 Site 90034-001Reus, Spain, 43204 Site 90034-002Zaragoza, Spain, 50009|GÃ¶teborg, Sweden, Se-41345 Site 90046-001Stockholm, Sweden, Se-11157 Site 90046-003Stockholm, Sweden, Se-14186|Mission Viejo, California, United States, 92691 Site 90001-001Newport Beach, California, United States, 92663 Site 90001-015Stanford, California, United States, 94305|Boca Raton, Florida, United States, 33434|Boston, Massachusetts, United States, 02114|Saint Paul, Minnesota, United States, 55102|Butte, Montana, United States, 59701|Las Vegas, Nevada, United States, 89119|Summit, New Jersey, United States, 07901|Cincinnati, Ohio, United States, 45227","California|Florida|Massachusetts|Minnesota|Montana|Nevada|New Jersey|Ohio","Canada|Czechia|Denmark|Netherlands|South Africa|Spain|Sweden|United States","Quebec Site 90011-005|Site 90420-001|Site 90045-001|Site 90031-001|, Western Cape Site 90027-004|Site 90027-003|Site 90034-003|Site 90046-002|Site 90001-005|Site 90001-047|Site 90001-004|Site 90001-056|Site 90001-012|Site 90001-112|Site 90001-014|Site 90001-002",{"$nulls":4},"2019-09-16","2020-05-25T16:36:22.465","2020-05-26T17:10:42.972","NCT03397121"]
["5ecbf408e2561b1b11905d29","NCT03397329","2018-01-12","Agios","AGIO","Completed","Study to Evaluate the Relative Bioavailability and Safety of the AG-348 Tablet and Capsule Formulations in Healthy Adults","Ag-348",null,"Yes","['Ag-348']","Unknown",null,"Phase 1",2,26,"Actual","2017-10-03","2017-11-13","AUC","Area Under The Curve",{"$nulls":3},"The purpose of this Phase 1, randomized, open-label, two-period crossover study is to characterize and compare the pharmacokinetic (PK) profiles and evaluate the safety of the AG-348 tablet and capsule formulations after single-dose administration in healthy adult subjects. Pharmacokinetic sampling will take place serially at specified times during conduct of the study.",null,"A Phase 1, Randomized, Open-Label, Two-Period Crossover Study Evaluating the Relative Bioavailability and Safety of the AG-348 Tablet and Capsule Formulations After Single-Dose Administration in Healthy Adults","AG348-C-005","Healthy Volunteers","Healthy Volunteers","Healthy","Healthy","Active Comparator","Sequence A|Sequence B",null,"Drug","AG-348 Sequence A|AG-348 Sequence B",null,null,"Sequence A|Sequence B","\n\n * Be a male or female aged 18 to 55 years, inclusive.\n * Have a body mass index (BMI) of â‰¥ 18.5 to â‰¤ 29.0 kg/m2 at Screening.\n * Agrees to abstain from any alcohol consumption.\n * Be healthy overall with no clinically significant medical abnormalities, as determined by the Investigator through evaluation of the subject's medical history and Screening vital signs, ECG, physical examination, and laboratory assessments.\n\n","\n\n * Have undergone any major surgical procedure within the 3 months prior to Screening.\n * Has at Screening or has had within the 12 months prior to Screening any significant illness.\n * Test positive at Screening for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCVAb), or human immunodeficiency virus (HIV).\n * Have a Screening systolic blood pressure (BP) reading of â‰¥140 mmHg (â‰¥150 mmHg in subjects >45 years of age) OR a diastolic BP reading of â‰¥90 mmHg.\n * Has any history of drug or alcohol abuse within the 2 years prior to Screening.\n * Is a current smoker or user of any other tobacco product.\n * Have had, including by voluntary donation, > 400 mL of blood collected within the 3 months prior to Screening.\n * Have taken within the 14 days prior to study drug dosing any prescription medication, over-the counter medication, or nonprescription preparationâ€”including vitamins, minerals, phytotherapeutic/herbal/plant-derived preparations, or grapefruit juiceâ€”unless deemed acceptable by the Investigator OR have taken within the 28 days prior to study drug dosing any restricted product known to strongly induce CYP3A4 metabolism (eg, St. John's Wort).\n * Have participated in another clinical research study within the 3 months prior to Screening.",{"$nulls":4},"Actual","2018-01-12","Actual","Actual","2017-11-13","Actual","2018-01-01","2017-10-25","2018-01-10","2018-01-10",null,"Healthy Volunteers","Interventional","Other","Crossover Assignment","None (Open Label)","Randomized","18 Years","55 Years","All",null,"Yes","No",{"$nulls":3},"Yes","No",{"$nulls":19},"Cmax|AUC0-last and AUC0-âˆž","AG-348 Maximum Plasma Concentration|AG-348 Area Under the Curve","Pharmacokinetic sampling for AG-348 will be taken for 72 hours (3 days) after single dose","Assessment of adverse events","From first dose of study drug to 10 (Â± 1) days after single-dose of AG-348]",{"$nulls":4},"Dallas, Texas, United States, 75247","Texas","United States","Covance Clinical Research Unit, Inc.",{"$nulls":4},"2018-01-10","2020-05-25T16:36:24.464","2020-05-26T17:10:42.972","NCT03397329"]
["5ecbf40b307e3d1b1f8d9cc5","NCT03397862","2018-01-12","Corium International","CORI","Recruiting","A Skin Irritation Assessment of Once-Weekly Corplexâ„¢ Donepezil Transdermal Delivery System","Donepezil","ACHE Inhibitor","Unknown",null,"Unknown",null,"Phase 1",2,250,"Anticipated","2017-11-14","2018-05-01",{"$nulls":5},"A study to assess the skin irritation and sensitization potential of Corplexâ„¢ Donepezil Transdermal Delivery System (TDS)","Multiple center, vehicle-controlled, randomized, double-blind and multiple-dose study.\n\nSubjects will be randomized prior to the first TDS application. Total duration of the study from Screening to Follow-up is approximately 95 days for subjects participating from the Induction Phase to the Challenge Phase and potentially up to 156 days for subjects further participating in the Re-Challenge Phase.\n\nSkin irritation will be monitored by visual scoring scales. TDS adhesion will be assessed during TDS wear period. Safety will be monitored throughout the study by clinical and laboratory evaluations.","A Randomized Double-Blind Study to Assess the Skin Irritation and Sensitization Potential of Once-Weekly Corplexâ„¢ Donepezil Transdermal Delivery System","P-16011","Skin Irritation\nSensitization",{"$nulls":3},"Experimental|Placebo Comparator","Corplex Donepezil TDS 5 mg/day|Vehicle TDS","Subjects will receive Corplex Donepezil TDS 5 mg/day during Induction, Challenge, and Re-Challenge phase.|Subjects will receive Vehicle TDS during Induction, Challenge, and Re-Challenge phase.","Drug","Donepezil TDS|Vehicle TDS","Donepezil patch|Placebo patch",null,"Corplex Donepezil TDS 5 mg/day|Vehicle TDS","\n\n * Healthy, adult, male or female\n * Body mass index â‰¥ 18.0 and â‰¤ 35.0 kg/m2\n * Medically healthy, as deemed by the Investigator\n * Have a skin type with Fitzpatrick scale score of I, II, or III\n\n","\n\n * History or presence of alcoholism or drug abuse\n * History or presence of hypersensitivity or idiosyncratic reaction to the study product or related compounds\n * Positive urine drug or alcohol results\n * Female subjects with a positive pregnancy test or who are lactating\n * Any of the following drugs, but not limited to, for 30 days prior to the first dose of study product treatment on Day 1 and throughout the study: 1. Inducers of cytochrome enzymes and/or P-glycoprotein\n    2. Anti-inflammatory drugs or cyclooxygenase 2 analgesics\n    3. Beta-blockers\n    4. Cholinergics and anticholinergics\n    5. Muscle relaxants, anti-Parkinsonian, or neuroleptic medications\n   \n   \n * History or presence of significant skin damage deemed by the investigator to potentially interfere\n * Any medical or surgical procedure or trauma\n * Participation in another clinical study within 30 days or 5 times the half-life of the investigational product (whichever is longer) prior to the first study product treatment",{"$nulls":4},"Actual","2018-01-12","Actual","Anticipated","2018-05-01","Anticipated","2018-01-01","2017-11-03","2018-01-09","2018-01-09","No",null,"Interventional","Other","Sequential Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","40 Years",null,"All",null,"Yes","No\nNo plans",{"$nulls":3},"Yes","No",{"$nulls":19},"Skin irritation of Corplex Donepezil TDS (Dermal Response Scale)|Skin irritation of Corplex Donepezil TDS (Other Effects Scale)|Skin sensitization potential of Corplex Donepezil TDS (Dermal Response Scale)|Skin sensitization potential of Corplex Donepezil TDS (Other Effects Scale)","Skin irritation will be measured using the Dermal Response Scale (8 point categorical scale using numeric values). Assessments will be collected 30 minutes after each TDS removal.|Skin irritation will be measured using the Other Effects Scale (6-point categorical scale using alphabet letters equivalent to numeric values). Assessments will be collected 30 minutes after each TDS removal.|Assessment of sensitization potential will be measured using the Dermal Response Scale (8-point categorical scale using numeric values). Assessments will be collected at 48 and 72 hours after TDS removal following the 2 day Challenge Phase and Re-Challenge Phase as applicable.|Assessment of sensitization potential will be measured using the Other Effects Scale (6-point categorical scale using alphabet letters equivalent to numeric values). Assessments will be collected at 48 and 72 hours after TDS removal following the 2 day Challenge Phase and Re-Challenge Phase as applicable.","Approximately 95 days from Screening to Follow-up up to 156 days","Skin irritation of Corplex Donepezil TDS compared to vehicle TDS (Dermal Response Scale)|Skin irritation of Corplex Donepezil TDS compared to vehicle TDS (Other Effects Scale)","Skin irritation will be measured using the Dermal Response Scale (8 point categorical scale using numeric values). Assessments will be collected 30 minutes after each TDS removal.|Skin irritation will be measured using the Other Effects Scale (6-point categorical scale using alphabet letters equivalent to numeric values). Assessments will be collected 30 minutes after each TDS removal.","Approximately 95 days from Screening to Follow-up up to 156 days","mcaruano@coriumintl.com","Melanie Caruano","650-808-7863","Phoenix, Arizona, United States, 85283|Lincoln, Nebraska, United States, 68502","Arizona|Nebraska","United States","Celerion Inc.","vmiller@coriumintl.com","Vaeling Miller","408-681-7888","Danielle Armas, MD, CPI Celerion Laura Sterling, MD, MPH Celerion Vaeling Miller","2018-01-09","2020-05-25T16:36:27.685","2020-05-26T17:10:42.972","NCT03397862"]
["5ecbf40b11702c1b1b916a45","NCT03397862","2018-02-13","Corium International","CORI","Recruiting","A Skin Irritation Assessment of Once-Weekly Corplexâ„¢ Donepezil Transdermal Delivery System","Donepezil","ACHE Inhibitor","Unknown",null,"Unknown",null,"Phase 1",2,250,"Anticipated","2017-11-14","2018-05-01",{"$nulls":5},"A study to assess the skin irritation and sensitization potential of Corplexâ„¢ Donepezil Transdermal Delivery System (TDS)","This study is a multiple center, randomized, double-blind, vehicle-controlled, and multiple-dose study to assess skin irritation and skin sensitization in healthy subjects.\n\nSubjects will be randomized prior to the first TDS application. The total duration of the study from Screening to Follow-up is approximately 95 days for subjects participating in the Induction Phase and the Challenge Phase of the study and potentially up to 156 days for subjects requiring to complete Re-Challenge Phase.\n\nSkin irritation will be monitored by visual scoring scales. TDS adhesion will be assessed during TDS wear period. Safety will be monitored throughout the study by clinical and laboratory evaluations.","A Randomized Double-Blind Study to Assess the Skin Irritation and Sensitization Potential of Once-Weekly Corplexâ„¢ Donepezil Transdermal Delivery System","P-16011","Skin Irritation\nSensitization","Healthy Volunteers","Healthy","Healthy","Experimental|Placebo Comparator","Corplex Donepezil TDS 5 mg/day|Vehicle TDS","Subjects will receive Corplex Donepezil TDS 5 mg/day during Induction, Challenge, and Re-Challenge phase.|Subjects will receive Vehicle TDS during Induction, Challenge, and Re-Challenge phase.","Drug","Donepezil TDS|Vehicle TDS","Donepezil patch|Placebo patch",null,"Corplex Donepezil TDS 5 mg/day|Vehicle TDS","\n\n * Healthy, adult, male or female\n * Body mass index â‰¥ 18.0 and â‰¤ 35.0 kg/m2\n * Medically healthy, as deemed by the Investigator\n * Have a skin type with Fitzpatrick scale score of I, II, or III\n\n","\n\n * History or presence of alcoholism or drug abuse\n * History or presence of hypersensitivity or idiosyncratic reaction to the study product or related compounds\n * Positive urine drug or alcohol results\n * Female subjects with a positive pregnancy test or who are lactating\n * Any of the following drugs, but not limited to, for 30 days prior to the first dose of study product treatment on Day 1 and throughout the study: 1. Inducers of cytochrome enzymes and/or P-glycoprotein\n    2. Anti-inflammatory drugs or cyclooxygenase 2 analgesics\n    3. Beta-blockers\n    4. Cholinergics and anticholinergics\n    5. Muscle relaxants, anti-Parkinsonian, or neuroleptic medications\n   \n   \n * History or presence of significant skin damage deemed by the investigator to potentially interfere\n * Any medical or surgical procedure or trauma\n * Participation in another clinical study within 30 days or 5 times the half-life of the investigational product (whichever is longer) prior to the first study product treatment",{"$nulls":4},"Actual","2018-01-12","Actual","Anticipated","2018-05-01","Anticipated","2018-02-01","2017-11-03","2018-01-09","2018-02-10","No",null,"Interventional","Other","Sequential Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","40 Years",null,"All",null,"Yes","No\nNo plans",{"$nulls":3},"Yes","No",{"$nulls":19},"Mean Cumulative Skin Irritation Score of Donepezil Corplex TDS (Induction Phase)|Number of Subjects with Skin sensitization potential of Corplex TDS (Challenge Phase)|Number of Subjects with Skin sensitization potential of Corplex TDS (Re-Challenge Phase)","Mean Cumulative skin irritation score is determined by averaging the combined Dermal Response score (8-point categorical scale using numeric values) and the Other Effects score (6-point categorical scale using alphabet letters equivalent to numeric values) during the induction phase of the study.|Subject's sensitization potential will be assessed using the combined Dermal Response score (8-point categorical scale using numeric values) and the Other Effects score (6-point categorical scale using alphabet letters equivalent to numeric values) . The last of 48 hr or 72 hr score collected after TDS removal during the Challenge Phase will be assessed. Provided the combined score is 2 or greater, it will then be compared to the skin irritation scores collected during the induction phase. If the last Challenge Phase score is 2 or greater and generally exceeds the skin irritation scores collected during the induction phase, the subject will return for the Re-Challenge phase.|Subject's sensitization potential will be assessed using the combined Dermal Response score (8-point categorical scale using numeric values) and the Other Effects score (6-point categorical scale using alphabet letters equivalent to numeric values). The last of 48 hr or 72 hr score collected after TDS removal during the Re-Challenge phase will be assessed. The subject will be considered for potential sensitization if they meet the same criteria in both Challenge phase and Re-Challenge phase (i.e. a combined score of 2 or greater at the last assessment at 48 hr or 72 hr post patch removal and the score are generally higher compared to induction phase scores.","Induction (21 days)|Challenge: Up to 5 days including 2-day TDS application and a 3-day visual scoring of the TDS application site following TDS removal|Re-Challenge: Up to 5 days including 2-day TDS application and a 3-day visual scoring of the TDS application site following TDS removal","Mean Cumulative Skin Irritation Score of Donepezil Corplex TDS compared to Vehicle TDS (Induction Phase)","Mean cumulative skin irritation will be determined and compared between Corplex Donepezil TDS and Vehicle TDS. Mean Cumulative skin irritation score is determined by averaging the combined Dermal Response score (8-point categorical scale using numeric values) and the Other Effects score (6-point categorical scale using alphabet letters equivalent to numeric values) during the induction phase of the study.","Induction (21 days)","vmiller@coriumintl.com","Vaeling Miller","650-353-7201","Phoenix, Arizona, United States, 85283|Lincoln, Nebraska, United States, 68502","Arizona|Nebraska","United States","Celerion Inc.","mcaruano@coriumintl.com","Melanie Caruano","650-353-2618","Danielle Armas, MD, CPI Celerion Laura Sterling, MD, MPH Celerion Vaeling Miller","2018-02-10","2020-05-25T16:36:27.702","2020-05-26T17:10:42.972","NCT03397862"]
["5ecbf40bfeab101b15530864","NCT03397862","2018-07-17","Corium International","CORI","Active, not recruiting","A Skin Irritation Assessment of Once-Weekly Corplexâ„¢ Donepezil Transdermal Delivery System","Donepezil","ACHE Inhibitor","Unknown",null,"Unknown",null,"Phase 1",2,256,"Actual","2017-11-14","2018-07-01",{"$nulls":5},"A study to assess the skin irritation and sensitization potential of Corplexâ„¢ Donepezil Transdermal Delivery System (TDS)","This study is a multiple center, randomized, double-blind, vehicle-controlled, and multiple-dose study to assess skin irritation and skin sensitization in healthy subjects.\n\nSubjects will be randomized prior to the first TDS application. The total duration of the study from Screening to Follow-up is approximately 95 days for subjects participating in the Induction Phase and the Challenge Phase of the study and potentially up to 156 days for subjects requiring to complete Re-Challenge Phase.\n\nSkin irritation will be monitored by visual scoring scales. TDS adhesion will be assessed during TDS wear period. Safety will be monitored throughout the study by clinical and laboratory evaluations.","A Randomized Double-Blind Study to Assess the Skin Irritation and Sensitization Potential of Once-Weekly Corplexâ„¢ Donepezil Transdermal Delivery System","P-16011","Skin Irritation\nSensitization","Healthy Volunteers","Healthy","Healthy","Experimental|Placebo Comparator","Corplex Donepezil TDS 5 mg/day|Vehicle TDS","Subjects will receive Corplex Donepezil TDS 5 mg/day during Induction, Challenge, and Re-Challenge phase.|Subjects will receive Vehicle TDS during Induction, Challenge, and Re-Challenge phase.","Drug","Donepezil TDS|Vehicle TDS","Donepezil patch|Placebo patch",null,"Corplex Donepezil TDS 5 mg/day|Vehicle TDS","\n\n * Healthy, adult, male or female\n * Body mass index â‰¥ 18.0 and â‰¤ 35.0 kg/m2\n * Medically healthy, as deemed by the Investigator\n * Have a skin type with Fitzpatrick scale score of I, II, or III\n\n","\n\n * History or presence of alcoholism or drug abuse\n * History or presence of hypersensitivity or idiosyncratic reaction to the study product or related compounds\n * Positive urine drug or alcohol results\n * Female subjects with a positive pregnancy test or who are lactating\n * Any of the following drugs, but not limited to, for 30 days prior to the first dose of study product treatment on Day 1 and throughout the study: 1. Inducers of cytochrome enzymes and/or P-glycoprotein\n    2. Anti-inflammatory drugs or cyclooxygenase 2 analgesics\n    3. Beta-blockers\n    4. Cholinergics and anticholinergics\n    5. Muscle relaxants, anti-Parkinsonian, or neuroleptic medications\n   \n   \n * History or presence of significant skin damage deemed by the investigator to potentially interfere\n * Any medical or surgical procedure or trauma\n * Participation in another clinical study within 30 days or 5 times the half-life of the investigational product (whichever is longer) prior to the first study product treatment",{"$nulls":4},"Actual","2018-01-12","Actual","Anticipated","2018-10-01","Anticipated","2018-07-01","2017-11-03","2018-01-09","2018-07-16","No",null,"Interventional","Other","Sequential Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","40 Years",null,"All",null,"Yes","No\nNo plans",{"$nulls":3},"Yes","No",{"$nulls":19},"Mean Cumulative Skin Irritation Score of Donepezil Corplex TDS (Induction Phase)|Number of Subjects with Skin sensitization potential of Corplex TDS (Challenge Phase)|Number of Subjects with Skin sensitization potential of Corplex TDS (Re-Challenge Phase)","Mean Cumulative skin irritation score is determined by averaging the combined Dermal Response score (8-point categorical scale using numeric values) and the Other Effects score (6-point categorical scale using alphabet letters equivalent to numeric values) during the induction phase of the study.|Subject's sensitization potential will be assessed using the combined Dermal Response score (8-point categorical scale using numeric values) and the Other Effects score (6-point categorical scale using alphabet letters equivalent to numeric values) . The last of 48 hr or 72 hr score collected after TDS removal during the Challenge Phase will be assessed. Provided the combined score is 2 or greater, it will then be compared to the skin irritation scores collected during the induction phase. If the last Challenge Phase score is 2 or greater and generally exceeds the skin irritation scores collected during the induction phase, the subject will return for the Re-Challenge phase.|Subject's sensitization potential will be assessed using the combined Dermal Response score (8-point categorical scale using numeric values) and the Other Effects score (6-point categorical scale using alphabet letters equivalent to numeric values). The last of 48 hr or 72 hr score collected after TDS removal during the Re-Challenge phase will be assessed. The subject will be considered for potential sensitization if they meet the same criteria in both Challenge phase and Re-Challenge phase (i.e. a combined score of 2 or greater at the last assessment at 48 hr or 72 hr post patch removal and the score are generally higher compared to induction phase scores.","Induction (21 days)|Challenge: Up to 5 days including 2-day TDS application and a 3-day visual scoring of the TDS application site following TDS removal|Re-Challenge: Up to 5 days including 2-day TDS application and a 3-day visual scoring of the TDS application site following TDS removal","Mean Cumulative Skin Irritation Score of Donepezil Corplex TDS compared to Vehicle TDS (Induction Phase)","Mean cumulative skin irritation will be determined and compared between Corplex Donepezil TDS and Vehicle TDS. Mean Cumulative skin irritation score is determined by averaging the combined Dermal Response score (8-point categorical scale using numeric values) and the Other Effects score (6-point categorical scale using alphabet letters equivalent to numeric values) during the induction phase of the study.","Induction (21 days)",{"$nulls":3},"Phoenix, Arizona, United States, 85283|Lincoln, Nebraska, United States, 68502","Arizona|Nebraska","United States","Celerion Inc.",{"$nulls":3},"Danielle Armas, MD, CPI Celerion Laura Sterling, MD, MPH Celerion Vaeling Miller","2018-07-16","2020-05-25T16:36:27.641","2020-05-26T17:10:42.972","NCT03397862"]
["5ecbf40cfeab101b15530865","NCT03397862","2018-09-14","Corium International","CORI","Completed","A Skin Irritation Assessment of Once-Weekly Corplexâ„¢ Donepezil Transdermal Delivery System","Donepezil","ACHE Inhibitor","Unknown",null,"Unknown",null,"Phase 1",2,256,"Actual","2017-11-14","2018-03-08",{"$nulls":5},"A study to assess the skin irritation and sensitization potential of Corplexâ„¢ Donepezil Transdermal Delivery System (TDS)","This study is a multiple center, randomized, double-blind, vehicle-controlled, and multiple-dose study to assess skin irritation and skin sensitization in healthy subjects.\n\nSubjects will be randomized prior to the first TDS application. The total duration of the study from Screening to Follow-up is approximately 95 days for subjects participating in the Induction Phase and the Challenge Phase of the study and potentially up to 156 days for subjects requiring to complete Re-Challenge Phase.\n\nSkin irritation will be monitored by visual scoring scales. TDS adhesion will be assessed during TDS wear period. Safety will be monitored throughout the study by clinical and laboratory evaluations.","A Randomized Double-Blind Study to Assess the Skin Irritation and Sensitization Potential of Once-Weekly Corplexâ„¢ Donepezil Transdermal Delivery System","P-16011","Skin Irritation\nSensitization","Healthy Volunteers","Healthy","Healthy","Experimental|Placebo Comparator","Corplex Donepezil TDS 5 mg/day|Vehicle TDS","Subjects will receive Corplex Donepezil TDS 5 mg/day during Induction, Challenge, and Re-Challenge phase.|Subjects will receive Vehicle TDS during Induction, Challenge, and Re-Challenge phase.","Drug","Donepezil TDS|Vehicle TDS","Donepezil patch|Placebo patch",null,"Corplex Donepezil TDS 5 mg/day|Vehicle TDS","\n\n * Healthy, adult, male or female\n * Body mass index â‰¥ 18.0 and â‰¤ 35.0 kg/m2\n * Medically healthy, as deemed by the Investigator\n * Have a skin type with Fitzpatrick scale score of I, II, or III\n\n","\n\n * History or presence of alcoholism or drug abuse\n * History or presence of hypersensitivity or idiosyncratic reaction to the study product or related compounds\n * Positive urine drug or alcohol results\n * Female subjects with a positive pregnancy test or who are lactating\n * Any of the following drugs, but not limited to, for 30 days prior to the first dose of study product treatment on Day 1 and throughout the study: 1. Inducers of cytochrome enzymes and/or P-glycoprotein\n    2. Anti-inflammatory drugs or cyclooxygenase 2 analgesics\n    3. Beta-blockers\n    4. Cholinergics and anticholinergics\n    5. Muscle relaxants, anti-Parkinsonian, or neuroleptic medications\n   \n   \n * History or presence of significant skin damage deemed by the investigator to potentially interfere\n * Any medical or surgical procedure or trauma\n * Participation in another clinical study within 30 days or 5 times the half-life of the investigational product (whichever is longer) prior to the first study product treatment",{"$nulls":4},"Actual","2018-01-12","Actual","Actual","2018-04-02","Actual","2018-09-01","2017-11-03","2018-01-09","2018-09-13","No",null,"Interventional","Other","Sequential Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","40 Years",null,"All",null,"Yes","No\nNo plans",{"$nulls":3},"Yes","No",{"$nulls":19},"Mean Cumulative Skin Irritation Score of Donepezil Corplex TDS (Induction Phase)|Number of Subjects with Skin sensitization potential of Corplex TDS (Challenge Phase)|Number of Subjects with Skin sensitization potential of Corplex TDS (Re-Challenge Phase)","Mean Cumulative skin irritation score is determined by averaging the combined Dermal Response score (8-point categorical scale using numeric values) and the Other Effects score (6-point categorical scale using alphabet letters equivalent to numeric values) during the induction phase of the study.|Subject's sensitization potential will be assessed using the combined Dermal Response score (8-point categorical scale using numeric values) and the Other Effects score (6-point categorical scale using alphabet letters equivalent to numeric values) . The last of 48 hr or 72 hr score collected after TDS removal during the Challenge Phase will be assessed. Provided the combined score is 2 or greater, it will then be compared to the skin irritation scores collected during the induction phase. If the last Challenge Phase score is 2 or greater and generally exceeds the skin irritation scores collected during the induction phase, the subject will return for the Re-Challenge phase.|Subject's sensitization potential will be assessed using the combined Dermal Response score (8-point categorical scale using numeric values) and the Other Effects score (6-point categorical scale using alphabet letters equivalent to numeric values). The last of 48 hr or 72 hr score collected after TDS removal during the Re-Challenge phase will be assessed. The subject will be considered for potential sensitization if they meet the same criteria in both Challenge phase and Re-Challenge phase (i.e. a combined score of 2 or greater at the last assessment at 48 hr or 72 hr post patch removal and the score are generally higher compared to induction phase scores.","Induction (21 days)|Challenge: Up to 5 days including 2-day TDS application and a 3-day visual scoring of the TDS application site following TDS removal|Re-Challenge: Up to 5 days including 2-day TDS application and a 3-day visual scoring of the TDS application site following TDS removal","Mean Cumulative Skin Irritation Score of Donepezil Corplex TDS compared to Vehicle TDS (Induction Phase)","Mean cumulative skin irritation will be determined and compared between Corplex Donepezil TDS and Vehicle TDS. Mean Cumulative skin irritation score is determined by averaging the combined Dermal Response score (8-point categorical scale using numeric values) and the Other Effects score (6-point categorical scale using alphabet letters equivalent to numeric values) during the induction phase of the study.","Induction (21 days)",{"$nulls":3},"Phoenix, Arizona, United States, 85283|Lincoln, Nebraska, United States, 68502","Arizona|Nebraska","United States","Celerion Inc.",{"$nulls":3},"Danielle Armas, MD, CPI Celerion Laura Sterling, MD, MPH Celerion Vaeling Miller","2018-09-13","2020-05-25T16:36:28.019","2020-05-26T17:10:42.972","NCT03397862"]
["5ecbf40c11702c1b1b916a47","NCT03397888","2018-01-12","Portola","PTLA","Recruiting","The Effect o f Hepatic Impairment on the Pharmacokinetics and Pharmacodynamics of Betrixiban, an Oral FXa Antagonist","Betrixaban","FXa Inhibitor","No",null,"No",null,"Phase 1",3,32,"Anticipated","2017-11-16","2018-01-01","AUC","Area Under The Curve",{"$nulls":3},"Single center, prospective open label PK and PD study of betrixaban in subjects with mild and moderate hepatic impairment vs healthy volunteers.",null,"The Effect o f Hepatic Impairment on the Pharmacokinetics and Pharmacodynamics of Betrixiban, an Oral FXa Antagonist","17-022","Hepatic Impairment",{"$nulls":3},"Experimental","Cohort 1|Cohort 2|Cohort 3","Mild Impairment, Child-Pugh Category A|Moderate Impairment, Child-Pugh Category B|Essentially Healthy man or woman without liver disease matched to Cohorts 1 & 2 for age, sex and weight.","Drug","Betrixaban","80 mg capsule",null,"Cohort 1|Cohort 2|Cohort 3","\n\n 1. Cohorts 1 & 2: Man or a woman 18 to 70 with stable chronic hepatic impairment disease due to cirrhosis confirmed by biopsy, ultrasound, CT or MRI (Cohort 1 - Mild impairment, Child-Pugh Category A; Cohort 2 - Moderate Impairment, Child-Pugh Category B). Cohort 3: essentially healthy man or woman without liver disease whose sex, age and weight match patients in Cohorts 1 & 2 in order to result in similar average demographics.\n 2. Body Mass Index between 18 and 35 kg*m-2 and weighs at least 50 kg.\n 3. Contraception. Men must agree to acceptable methods of contraception. Women of child-bearing potential must agree to two acceptable forms of contraception. Post-menopausal women must have had no regular menstrual bleeding for at least one year prior to initial dosing and confirmed by an elevated plasma Follicle-stimulating hormone level test at screening for women not in receipt of hormone replacement therapy (HRT). Women who report surgical sterilization must have had the procedure at least six months prior to dosing, supported by clinical documentation.\n 4. The subject has clinical unremarkable medical history, physical examination, ECG, laboratory values and vital signs, as determined by the investigator. Subjects in Cohorts 1 & 2 may have: abnormal liver function tests, INR up to 2.2, PT up to 6 seconds over control, aPPT up to 45 seconds and platelets down to 45,000/uL.\n 5. The subject smokes <12 cigarettes per day or equivalent and agrees to no or reduced tobacco products while domiciled.\n 6. The subject is able to read and give written informed consent and signed the IRB approved consent form.\n 7. The subject has adequate venous access for blood sampling.\n\n","\n\n 1.  The subject has a history, symptoms of, or risk factors for bleeding or a stool specimen within 6 months of dosing positive for occult blood.\n 2.  The subject has an absolute/relative contraindication to anticoagulation due to: history of intracranial bleeding, severe active bleeding, recent brain, eye, or spinal cord surgery or major surgery within 6 months of dosing.\n 3.  The subject has a history of or risk factors for a hypercoagulable or thrombotic condition.\n 4.  The subject has a history of any clinically significant cardiac, endocrinologic, hematologic, hepatic (except for Cohorts 1 & 2), immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal or other major disease other than the underlying disease in Cohorts 1 & 2.\n 5.  The subject has a calculated creatinine clearance of <60mL/min as determined by Cockcroft-Gault method.\n 6.  Concomitant medication use: 1. For all subjects, illicit drugs, oral contraceptives, and hormone replacement therapy are excluded within 30 days prior to Day -1.\n      2. For all subjects, over the counter drugs, including dietary supplements and herbal products are excluded within 14 days prior to Day -1.\n      3. Subjects enrolled in Cohort 3 will be excluded if the subject has taken any prescription drugs in the 30 days prior to dosing. Furthermore, the subject will be excluded if he/she does not agree to refrain from concomitant drugs throughout the study unless medically necessary as determined by the Investigator.\n      4. Subjects enrolled in Cohort 1 and 2 may continue taking stable preexisting medications throughout the study with the exception of strong P-gp inhibitors. Strong P-gp inhibitors include but are not limited to: amiodarone, azithromycin, clarithromycin, erythromycin, ketoconazole, and verapamil. Prescribed stable acetaminophen use up to 2,000 mg per day is allowable. Any acetaminophen use with alcohol within 48 hours of dosing is prohibited. Furthermore, the subject will be excluded if he/she does not agree to refrain from additional concomitant drugs throughout the study unless medically necessary as determined by the Investigator.\n     \n     \n 7.  The subject has a history of severe trauma or bone fracture within 6 months prior to dosing; or planned surgery within 1 month after dosing.\n 8.  The subject has a history of blood donation of more than 500mL within 3 months prior to dosing.\n 9.  The subject has received an investigational drug product within 30 days or 5 half-lives of the investigational compound, whichever is greater, from Day -1.\n 10. The subject has positive screen for drugs of abuse at Day -1.\n 11. The subject does not agree to withhold from alcohol consumption from 48 hours prior to dosing through discharge.\n 12. The subject has a medical or surgical condition which may impair drug absorption.\n 13. The subject is pregnant or breastfeeding.\n 14. The subject has any condition which could interfere with or for which the treatment might interfere with the conduct of the study, or would, in the opinion of the Investigator, increase the risk of the subject's participation in the study.",{"$nulls":4},"Actual","2018-01-12","Actual","Anticipated","2018-05-01","Anticipated","2017-12-01","2017-12-07","2018-01-05","2018-01-05","No",null,"Interventional","Prevention","Parallel Assignment","None (Open Label)","Non-Randomized","18 Years","70 Years","All",null,"Yes",{"$nulls":4},"Yes","No",{"$nulls":19},"PK - Plasma half-life (t1/2)|PK - Tmax|PK - Cmax|PK - AUC (0-last)|PK - (AUC(0-âˆž)).|PK - Volume of distribution|PK - Total clearance","Plasma half-life (t1/2), distribution half-life and terminal half-life.|Time to maximum observed plasma concentration (Tmax).|Maximum observed plasma concentration (Cmax)|Area under the plasma concentration-time curve from 0 to last measurable concentration (AUC (0-last)).|Total area under the plasma concentration-time curve from time 0 to infinity (AUC(0-âˆž)).|Apparent volume of distribution (Vd/F).|Apparent total clearance (CL/F).","Day 1 through Day 6","Safety - Treatment Emergent AEs|Safety - Demographics|Safety - Vital Signs Temperature|Safety - Vital Signs Respiratory Rate|Safety - Vital Signs Heart Rate|Safety - Vital Signs Blood Pressure|Safety - 12 Lead ECG - PR|Safety - 12 Lead ECG - RR|Safety - 12 Lead ECG - WRS|Safety - 12 Lead ECG - QT|Safety - 12 Lead ECG - QTcF|Safety - 12 Lead ECG - QTcB|Safety - Physical Exam - Height|Safety - Physical Exam - Weight|Safety - Lab - Hematology - hemoglobin|Safety - Lab - Hematology - hematocrit|Safety - Lab - Hematology - white blood cell [WBC]|Safety - Lab - Hematology - Platelet Count|Safety - Lab - Hematology - Absolute Neutrophil Count|Safety - Lab - Hematology - Absolute Basophils|Safety - Lab - Hematology - Eosinophil's|Safety - Lab - Hematology - Lymphocytes|Safety - Lab - Hematology - Mean Corpuscular Hemoglobin|Safety - Lab - Hematology - Mean Corpuscular Hemoglobin Concentration|Safety - Lab - Hematology - Mean Corpuscular Hemoglobin Volume|Safety - Lab - Hematology - Monocytes|Safety - Lab - Hematology - Neutrophils|Safety - Lab - Hematology - Red Blood Cell Count|Safety - Lab - Hematology - Red Cell Distribution Width|Safety - Lab - Hematology - Reticulocyte|Safety- Lab - Coagulation - PT|Safety- Lab - Coagulation - INR|Safety- Lab - Coagulation - aPTT|Safety- Lab - Coagulation - Factor V Leiden|Safety - Lab - Serum Chemistry - Sodium|Safety - Lab - Serum Chemistry - Potassium|Safety - Lab - Serum Chemistry - Chloride|Safety - Lab - Serum Chemistry - Carbon Dioxide|Safety - Lab - Serum Chemistry - Glucose|Safety - Lab - Serum Chemistry - Blood Urea Nitrogen|Safety - Lab - Serum Chemistry - Creatinine|Safety - Lab - Serum Chemistry - AST|Safety - Lab - Serum Chemistry - ALT|Safety - Lab - Serum Chemistry - GGT|Safety - Lab - Serum Chemistry - Total Protein|Safety - Lab - Serum Chemistry - Albumin|Safety - Lab - Serum Chemistry - Alkaline Phosphatase|Safety - Lab - Serum Chemistry - Calcium|Safety - Lab - Serum Chemistry - Phosphorus|Safety - Lab - Serum Chemistry - Total Bilirubin|Safety - Lab - Serum Chemistry - Fractionated Bilirubin|Safety - Lab - Serum Chemistry - Uric Acid|Safety - Lab - Serum Chemistry - LDH|Safety - Lab - Urine toxicology Panel - Amphetamines|Safety - Lab - Urine toxicology Panel - Barbiturates|Safety - Lab - Urine toxicology Panel - Cannabinoids|Safety - Lab - Urine toxicology Panel - Cocaine|Safety - Lab - Urine toxicology Panel - Ethanol|Safety - Lab - Urine toxicology Panel - Opiates|Safety - Lab - Urinalysis - Specific Gravity|Safety - Lab - Urinalysis - pH|Safety - Lab - Urinalysis - Glucose|Safety - Lab - Urinalysis - Protein|Safety - Lab - Urinalysis - Hemoglobin|Safety - Lab - Urinalysis - Leukocyte esterase|Safety - Lab - Urinalysis - Nitrate|Safety - Urine Occult Blood Testing|Safety - Fecal Occult Blood Testing|Safety - Lab - Blood Virology - HIV I|Safety - Lab - Blood Virology - HIV II|Safety - Lab - Blood Virology - Hepatitis B|Safety - Lab - Blood Virology - Hepatitis C|Safety - Lab - Serum Pregnancy|PD - Anti-Factor Xa Concentration|PD - Thrombin Concentrations","Safety evaluation will study the adverse event (AE) profile|Safety will be evaluated by assessment of Demographics|Safety will be evaluated by assessment of Temperature - Celsius|Safety will be evaluated by assessment of Respiratory Rate - Breaths per Minute|Safety will be evaluated by assessment of Heart Rate - Beats per Minute|Safety will be evaluated by assessment of Blood Pressure - mmHg|Safety will be evaluated by assessment of 12 ECG - PR (ms)|Safety will be evaluated by assessment of 12 ECG - RR (ms)|Safety will be evaluated by assessment of 12 ECG - WRS (ms)|Safety will be evaluated by assessment of 12 ECG - QT (ms)|Safety will be evaluated by assessment of 12 ECG - QTcF (ms)|Safety will be evaluated by assessment of 12 ECG - QTcB (ms)|Safety will be evaluated by assessment Physical Exam - Height (centimeters)|Safety will be evaluated by assessment Physical Exam - Weight (kilogram)|Safety will be evaluated by analyzing Hematology - hemoglobin (g/dL)|Safety will be evaluated by analyzing Hematology - hematocrit (%)|Safety will be evaluated by analyzing Hematology - WBC (K/UL)|Safety will be evaluated by analyzing Platelet Count (Plt/mL)|Safety will be evaluated by analyzing Absolute Neutrophil Count (K/UL)|Safety will be evaluated by analyzing Absolute Basophils (K/UL)|Safety will be evaluated by analyzing Eosinophil's (K/UL)|Safety will be evaluated by analyzing Lymphocytes (K/UL)|Safety will be evaluated by analyzing Mean Corpuscular Hemoglobin (PG)|Safety will be evaluated by analyzing Mean Corpuscular Hemoglobin Concentration (g/dL)|Safety will be evaluated by analyzing Mean Corpuscular Hemoglobin Volume (FL)|Safety will be evaluated by analyzing Monocytes (K/UL)|Safety will be evaluated by analyzing Neutrophils (K/UL)|Safety will be evaluated by analyzing Red Blood Cell Count (MIL/UL)|Safety will be evaluated by analyzing Red Cell Distribution Width (%)|Safety will be evaluated by analyzing Reticulocyte (K/UL)|Safety will be evaluated by analyzing Coagulation - PT (seconds)|Safety will be evaluated by analyzing Coagulation - INR (no unit)|Safety will be evaluated by analyzing Coagulation - aPTT (seconds)|Safety will be evaluated by analyzing Coagulation - Factor V Leiden (positive/negative)|Safety will be evaluated by analyzing Serum Chemistry - Sodium (mEq/L)|Safety will be evaluated by analyzing Serum Chemistry - Potassium (mEq/L)|Safety will be evaluated by analyzing Serum Chemistry - Chloride (mEq/L)|Safety will be evaluated by analyzing Serum Chemistry - Carbon Dioxide (mEq/L)|Safety will be evaluated by analyzing Serum Chemistry - Glucose (mg/dL)|Safety will be evaluated by analyzing Serum Chemistry - Blood Urea Nitrogen (mg/dL)|Safety will be evaluated by analyzing Serum Chemistry - Creatinine (mg/dL)|Safety will be evaluated by analyzing Serum Chemistry - AST (U/L)|Safety will be evaluated by analyzing Serum Chemistry - ALT (U/L)|Safety will be evaluated by analyzing Serum Chemistry - GGT (U/L)|Safety will be evaluated by analyzing Serum Chemistry - Total Protein (g/dL)|Safety will be evaluated by analyzing Serum Chemistry - Albumin(g/dL)|Safety will be evaluated by analyzing Serum Chemistry - Alkaline Phosphatase (U/L)|Safety will be evaluated by analyzing Serum Chemistry - Calcium (mg/dL)|Safety will be evaluated by analyzing Serum Chemistry - Phosphorus (mg/dL)|Safety will be evaluated by analyzing Serum Chemistry - Total Bilirubin (mg/dL)|Safety will be evaluated by analyzing Serum Chemistry - Fractionated Bilirubin(mg/dL)|Safety will be evaluated by analyzing Serum Chemistry - Uric Acid (mg/dL)|Safety will be evaluated by analyzing Serum Chemistry LDH (U/L)|Safety will be evaluated by analyzing Urine toxicology Panel - Amphetamines (NG/ML)|Safety will be evaluated by analyzing Urine toxicology Panel - Barbiturates (NG/ML)|Safety will be evaluated by analyzing Urine toxicology Panel - Cannabinoids (NG/ML)|Safety will be evaluated by analyzing Urine toxicology Panel - Cocaine (NG/ML)|Safety will be evaluated by analyzing Urine toxicology Panel - Ethanol (MG/DL)|Safety will be evaluated by analyzing Urine toxicology Panel - Opiates (NG/ML)|Safety will be evaluated by analyzing Urinalysis - Specific Gravity (no unit)|Safety will be evaluated by analyzing Urinalysis - pH (no unit)|Safety will be evaluated by analyzing Urinalysis - Glucose (no unit)|Safety will be evaluated by analyzing Urinalysis - Protein (no unit)|Safety will be evaluated by analyzing Urinalysis - Hemoglobin (no unit)|Safety will be evaluated by analyzing Urinalysis - Leukocyte esterase (no unit)|Safety will be evaluated by analyzing Urinalysis - Nitrate (no unit)|Safety will be evaluated by assessment of Urine Occult Blood Testing (positive/negative)|Safety will be evaluated by assessment of Fecal Occult Blood Testing (positive/negative)|Safety will be evaluated by analyzing Blood Virology - HIV I (positive/negative)|Safety will be evaluated by analyzing Blood Virology - HIV II (positive/negative)|Safety will be evaluated by analyzing Blood Virology - Hepatitis B (positive/negative)|Safety will be evaluated by analyzing Blood Virology - Hepatitis C (positive/negative)|Safety will be evaluated by analyzing Serum Pregnancy|Anti-fXa will be analyzed for changes/percent changes from baseline over time.|Thrombin will be analyzed for changes/percent changes from baseline over time.","Day -1 through up to Day 21|Day -30 through Day -2 (Screening)|Day -30 through up to Day 21|Day -30 through Day -1|Day -30 through Day -2 (screening)|Day-30 through Day -2 (Screening)|Day 1 through Day 6","sblock@portola.com","Study Trial Contact","650-246-7000","Hialeah, Florida, United States, 33014","Florida","United States","Clinical Pharmacology Of Miami",{"$nulls":4},"2018-01-05","2020-05-25T16:36:28.741","2020-05-26T17:10:42.972","NCT03397888"]
["5ecbf40dfeab101b15530867","NCT03397888","2018-02-06","Portola","PTLA","Completed","The Effect o f Hepatic Impairment on the Pharmacokinetics and Pharmacodynamics of Betrixiban, an Oral FXa Antagonist","Betrixaban","FXa Inhibitor","No",null,"No",null,"Phase 1",3,32,"Actual","2017-11-16","2018-01-16","AUC","Area Under The Curve",{"$nulls":3},"Single center, prospective open label PK and PD study of betrixaban in subjects with mild and moderate hepatic impairment vs healthy volunteers.",null,"The Effect o f Hepatic Impairment on the Pharmacokinetics and Pharmacodynamics of Betrixiban, an Oral FXa Antagonist","17-022","Hepatic Impairment",{"$nulls":3},"Experimental","Cohort 1|Cohort 2|Cohort 3","Mild Impairment, Child-Pugh Category A|Moderate Impairment, Child-Pugh Category B|Essentially Healthy man or woman without liver disease matched to Cohorts 1 & 2 for age, sex and weight.","Drug","Betrixaban","80 mg capsule",null,"Cohort 1|Cohort 2|Cohort 3","\n\n 1. Cohorts 1 & 2: Man or a woman 18 to 70 with stable chronic hepatic impairment disease due to cirrhosis confirmed by biopsy, ultrasound, CT or MRI (Cohort 1 - Mild impairment, Child-Pugh Category A; Cohort 2 - Moderate Impairment, Child-Pugh Category B). Cohort 3: essentially healthy man or woman without liver disease whose sex, age and weight match patients in Cohorts 1 & 2 in order to result in similar average demographics.\n 2. Body Mass Index between 18 and 35 kg*m-2 and weighs at least 50 kg.\n 3. Contraception. Men must agree to acceptable methods of contraception. Women of child-bearing potential must agree to two acceptable forms of contraception. Post-menopausal women must have had no regular menstrual bleeding for at least one year prior to initial dosing and confirmed by an elevated plasma Follicle-stimulating hormone level test at screening for women not in receipt of hormone replacement therapy (HRT). Women who report surgical sterilization must have had the procedure at least six months prior to dosing, supported by clinical documentation.\n 4. The subject has clinical unremarkable medical history, physical examination, ECG, laboratory values and vital signs, as determined by the investigator. Subjects in Cohorts 1 & 2 may have: abnormal liver function tests, INR up to 2.2, PT up to 6 seconds over control, aPPT up to 45 seconds and platelets down to 45,000/uL.\n 5. The subject smokes <12 cigarettes per day or equivalent and agrees to no or reduced tobacco products while domiciled.\n 6. The subject is able to read and give written informed consent and signed the IRB approved consent form.\n 7. The subject has adequate venous access for blood sampling.\n\n","\n\n 1.  The subject has a history, symptoms of, or risk factors for bleeding or a stool specimen within 6 months of dosing positive for occult blood.\n 2.  The subject has an absolute/relative contraindication to anticoagulation due to: history of intracranial bleeding, severe active bleeding, recent brain, eye, or spinal cord surgery or major surgery within 6 months of dosing.\n 3.  The subject has a history of or risk factors for a hypercoagulable or thrombotic condition.\n 4.  The subject has a history of any clinically significant cardiac, endocrinologic, hematologic, hepatic (except for Cohorts 1 & 2), immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal or other major disease other than the underlying disease in Cohorts 1 & 2.\n 5.  The subject has a calculated creatinine clearance of <60mL/min as determined by Cockcroft-Gault method.\n 6.  Concomitant medication use: 1. For all subjects, illicit drugs, oral contraceptives, and hormone replacement therapy are excluded within 30 days prior to Day -1.\n      2. For all subjects, over the counter drugs, including dietary supplements and herbal products are excluded within 14 days prior to Day -1.\n      3. Subjects enrolled in Cohort 3 will be excluded if the subject has taken any prescription drugs in the 30 days prior to dosing. Furthermore, the subject will be excluded if he/she does not agree to refrain from concomitant drugs throughout the study unless medically necessary as determined by the Investigator.\n      4. Subjects enrolled in Cohort 1 and 2 may continue taking stable preexisting medications throughout the study with the exception of strong P-gp inhibitors. Strong P-gp inhibitors include but are not limited to: amiodarone, azithromycin, clarithromycin, erythromycin, ketoconazole, and verapamil. Prescribed stable acetaminophen use up to 2,000 mg per day is allowable. Any acetaminophen use with alcohol within 48 hours of dosing is prohibited. Furthermore, the subject will be excluded if he/she does not agree to refrain from additional concomitant drugs throughout the study unless medically necessary as determined by the Investigator.\n     \n     \n 7.  The subject has a history of severe trauma or bone fracture within 6 months prior to dosing; or planned surgery within 1 month after dosing.\n 8.  The subject has a history of blood donation of more than 500mL within 3 months prior to dosing.\n 9.  The subject has received an investigational drug product within 30 days or 5 half-lives of the investigational compound, whichever is greater, from Day -1.\n 10. The subject has positive screen for drugs of abuse at Day -1.\n 11. The subject does not agree to withhold from alcohol consumption from 48 hours prior to dosing through discharge.\n 12. The subject has a medical or surgical condition which may impair drug absorption.\n 13. The subject is pregnant or breastfeeding.\n 14. The subject has any condition which could interfere with or for which the treatment might interfere with the conduct of the study, or would, in the opinion of the Investigator, increase the risk of the subject's participation in the study.",{"$nulls":4},"Actual","2018-01-12","Actual","Actual","2018-01-16","Actual","2017-12-01","2017-12-07","2018-01-05","2018-02-05","No",null,"Interventional","Prevention","Parallel Assignment","None (Open Label)","Non-Randomized","18 Years","70 Years","All",null,"Yes",{"$nulls":4},"Yes","No",{"$nulls":19},"PK - Plasma half-life (t1/2)|PK - Tmax|PK - Cmax|PK - AUC (0-last)|PK - (AUC(0-âˆž)).|PK - Volume of distribution|PK - Total clearance","Plasma half-life (t1/2), distribution half-life and terminal half-life.|Time to maximum observed plasma concentration (Tmax).|Maximum observed plasma concentration (Cmax)|Area under the plasma concentration-time curve from 0 to last measurable concentration (AUC (0-last)).|Total area under the plasma concentration-time curve from time 0 to infinity (AUC(0-âˆž)).|Apparent volume of distribution (Vd/F).|Apparent total clearance (CL/F).","Day 1 through Day 6","Safety - Treatment Emergent AEs|Safety - Demographics|Safety - Vital Signs Temperature|Safety - Vital Signs Respiratory Rate|Safety - Vital Signs Heart Rate|Safety - Vital Signs Blood Pressure|Safety - 12 Lead ECG - PR|Safety - 12 Lead ECG - RR|Safety - 12 Lead ECG - WRS|Safety - 12 Lead ECG - QT|Safety - 12 Lead ECG - QTcF|Safety - 12 Lead ECG - QTcB|Safety - Physical Exam - Height|Safety - Physical Exam - Weight|Safety - Lab - Hematology - hemoglobin|Safety - Lab - Hematology - hematocrit|Safety - Lab - Hematology - white blood cell [WBC]|Safety - Lab - Hematology - Platelet Count|Safety - Lab - Hematology - Absolute Neutrophil Count|Safety - Lab - Hematology - Absolute Basophils|Safety - Lab - Hematology - Eosinophil's|Safety - Lab - Hematology - Lymphocytes|Safety - Lab - Hematology - Mean Corpuscular Hemoglobin|Safety - Lab - Hematology - Mean Corpuscular Hemoglobin Concentration|Safety - Lab - Hematology - Mean Corpuscular Hemoglobin Volume|Safety - Lab - Hematology - Monocytes|Safety - Lab - Hematology - Neutrophils|Safety - Lab - Hematology - Red Blood Cell Count|Safety - Lab - Hematology - Red Cell Distribution Width|Safety - Lab - Hematology - Reticulocyte|Safety- Lab - Coagulation - PT|Safety- Lab - Coagulation - INR|Safety- Lab - Coagulation - aPTT|Safety- Lab - Coagulation - Factor V Leiden|Safety - Lab - Serum Chemistry - Sodium|Safety - Lab - Serum Chemistry - Potassium|Safety - Lab - Serum Chemistry - Chloride|Safety - Lab - Serum Chemistry - Carbon Dioxide|Safety - Lab - Serum Chemistry - Glucose|Safety - Lab - Serum Chemistry - Blood Urea Nitrogen|Safety - Lab - Serum Chemistry - Creatinine|Safety - Lab - Serum Chemistry - AST|Safety - Lab - Serum Chemistry - ALT|Safety - Lab - Serum Chemistry - GGT|Safety - Lab - Serum Chemistry - Total Protein|Safety - Lab - Serum Chemistry - Albumin|Safety - Lab - Serum Chemistry - Alkaline Phosphatase|Safety - Lab - Serum Chemistry - Calcium|Safety - Lab - Serum Chemistry - Phosphorus|Safety - Lab - Serum Chemistry - Total Bilirubin|Safety - Lab - Serum Chemistry - Fractionated Bilirubin|Safety - Lab - Serum Chemistry - Uric Acid|Safety - Lab - Serum Chemistry - LDH|Safety - Lab - Urine toxicology Panel - Amphetamines|Safety - Lab - Urine toxicology Panel - Barbiturates|Safety - Lab - Urine toxicology Panel - Cannabinoids|Safety - Lab - Urine toxicology Panel - Cocaine|Safety - Lab - Urine toxicology Panel - Ethanol|Safety - Lab - Urine toxicology Panel - Opiates|Safety - Lab - Urinalysis - Specific Gravity|Safety - Lab - Urinalysis - pH|Safety - Lab - Urinalysis - Glucose|Safety - Lab - Urinalysis - Protein|Safety - Lab - Urinalysis - Hemoglobin|Safety - Lab - Urinalysis - Leukocyte esterase|Safety - Lab - Urinalysis - Nitrate|Safety - Urine Occult Blood Testing|Safety - Fecal Occult Blood Testing|Safety - Lab - Blood Virology - HIV I|Safety - Lab - Blood Virology - HIV II|Safety - Lab - Blood Virology - Hepatitis B|Safety - Lab - Blood Virology - Hepatitis C|Safety - Lab - Serum Pregnancy|PD - Anti-Factor Xa Concentration|PD - Thrombin Concentrations","Safety evaluation will study the adverse event (AE) profile|Safety will be evaluated by assessment of Demographics|Safety will be evaluated by assessment of Temperature - Celsius|Safety will be evaluated by assessment of Respiratory Rate - Breaths per Minute|Safety will be evaluated by assessment of Heart Rate - Beats per Minute|Safety will be evaluated by assessment of Blood Pressure - mmHg|Safety will be evaluated by assessment of 12 ECG - PR (ms)|Safety will be evaluated by assessment of 12 ECG - RR (ms)|Safety will be evaluated by assessment of 12 ECG - WRS (ms)|Safety will be evaluated by assessment of 12 ECG - QT (ms)|Safety will be evaluated by assessment of 12 ECG - QTcF (ms)|Safety will be evaluated by assessment of 12 ECG - QTcB (ms)|Safety will be evaluated by assessment Physical Exam - Height (centimeters)|Safety will be evaluated by assessment Physical Exam - Weight (kilogram)|Safety will be evaluated by analyzing Hematology - hemoglobin (g/dL)|Safety will be evaluated by analyzing Hematology - hematocrit (%)|Safety will be evaluated by analyzing Hematology - WBC (K/UL)|Safety will be evaluated by analyzing Platelet Count (Plt/mL)|Safety will be evaluated by analyzing Absolute Neutrophil Count (K/UL)|Safety will be evaluated by analyzing Absolute Basophils (K/UL)|Safety will be evaluated by analyzing Eosinophil's (K/UL)|Safety will be evaluated by analyzing Lymphocytes (K/UL)|Safety will be evaluated by analyzing Mean Corpuscular Hemoglobin (PG)|Safety will be evaluated by analyzing Mean Corpuscular Hemoglobin Concentration (g/dL)|Safety will be evaluated by analyzing Mean Corpuscular Hemoglobin Volume (FL)|Safety will be evaluated by analyzing Monocytes (K/UL)|Safety will be evaluated by analyzing Neutrophils (K/UL)|Safety will be evaluated by analyzing Red Blood Cell Count (MIL/UL)|Safety will be evaluated by analyzing Red Cell Distribution Width (%)|Safety will be evaluated by analyzing Reticulocyte (K/UL)|Safety will be evaluated by analyzing Coagulation - PT (seconds)|Safety will be evaluated by analyzing Coagulation - INR (no unit)|Safety will be evaluated by analyzing Coagulation - aPTT (seconds)|Safety will be evaluated by analyzing Coagulation - Factor V Leiden (positive/negative)|Safety will be evaluated by analyzing Serum Chemistry - Sodium (mEq/L)|Safety will be evaluated by analyzing Serum Chemistry - Potassium (mEq/L)|Safety will be evaluated by analyzing Serum Chemistry - Chloride (mEq/L)|Safety will be evaluated by analyzing Serum Chemistry - Carbon Dioxide (mEq/L)|Safety will be evaluated by analyzing Serum Chemistry - Glucose (mg/dL)|Safety will be evaluated by analyzing Serum Chemistry - Blood Urea Nitrogen (mg/dL)|Safety will be evaluated by analyzing Serum Chemistry - Creatinine (mg/dL)|Safety will be evaluated by analyzing Serum Chemistry - AST (U/L)|Safety will be evaluated by analyzing Serum Chemistry - ALT (U/L)|Safety will be evaluated by analyzing Serum Chemistry - GGT (U/L)|Safety will be evaluated by analyzing Serum Chemistry - Total Protein (g/dL)|Safety will be evaluated by analyzing Serum Chemistry - Albumin(g/dL)|Safety will be evaluated by analyzing Serum Chemistry - Alkaline Phosphatase (U/L)|Safety will be evaluated by analyzing Serum Chemistry - Calcium (mg/dL)|Safety will be evaluated by analyzing Serum Chemistry - Phosphorus (mg/dL)|Safety will be evaluated by analyzing Serum Chemistry - Total Bilirubin (mg/dL)|Safety will be evaluated by analyzing Serum Chemistry - Fractionated Bilirubin(mg/dL)|Safety will be evaluated by analyzing Serum Chemistry - Uric Acid (mg/dL)|Safety will be evaluated by analyzing Serum Chemistry LDH (U/L)|Safety will be evaluated by analyzing Urine toxicology Panel - Amphetamines (NG/ML)|Safety will be evaluated by analyzing Urine toxicology Panel - Barbiturates (NG/ML)|Safety will be evaluated by analyzing Urine toxicology Panel - Cannabinoids (NG/ML)|Safety will be evaluated by analyzing Urine toxicology Panel - Cocaine (NG/ML)|Safety will be evaluated by analyzing Urine toxicology Panel - Ethanol (MG/DL)|Safety will be evaluated by analyzing Urine toxicology Panel - Opiates (NG/ML)|Safety will be evaluated by analyzing Urinalysis - Specific Gravity (no unit)|Safety will be evaluated by analyzing Urinalysis - pH (no unit)|Safety will be evaluated by analyzing Urinalysis - Glucose (no unit)|Safety will be evaluated by analyzing Urinalysis - Protein (no unit)|Safety will be evaluated by analyzing Urinalysis - Hemoglobin (no unit)|Safety will be evaluated by analyzing Urinalysis - Leukocyte esterase (no unit)|Safety will be evaluated by analyzing Urinalysis - Nitrate (no unit)|Safety will be evaluated by assessment of Urine Occult Blood Testing (positive/negative)|Safety will be evaluated by assessment of Fecal Occult Blood Testing (positive/negative)|Safety will be evaluated by analyzing Blood Virology - HIV I (positive/negative)|Safety will be evaluated by analyzing Blood Virology - HIV II (positive/negative)|Safety will be evaluated by analyzing Blood Virology - Hepatitis B (positive/negative)|Safety will be evaluated by analyzing Blood Virology - Hepatitis C (positive/negative)|Safety will be evaluated by analyzing Serum Pregnancy|Anti-fXa will be analyzed for changes/percent changes from baseline over time.|Thrombin will be analyzed for changes/percent changes from baseline over time.","Day -1 through up to Day 21|Day -30 through Day -2 (Screening)|Day -30 through up to Day 21|Day -30 through Day -1|Day -30 through Day -2 (screening)|Day-30 through Day -2 (Screening)|Day 1 through Day 6",{"$nulls":3},"Hialeah, Florida, United States, 33014","Florida","United States","Clinical Pharmacology Of Miami",{"$nulls":4},"2018-02-05","2020-05-25T16:36:29.549","2020-05-26T17:10:42.972","NCT03397888"]
["5ecbf40ce2561b1b11905d32","NCT03397888","2018-09-24","Portola","PTLA","Completed","The Effect o f Hepatic Impairment on the Pharmacokinetics and Pharmacodynamics of Betrixiban, an Oral FXa Antagonist","Betrixaban","FXa Inhibitor","No",null,"No",null,"Phase 1",3,32,"Actual","2017-11-16","2018-01-16","AUC","Area Under The Curve",{"$nulls":3},"Single center, prospective open label PK and PD study of betrixaban in subjects with mild and moderate hepatic impairment vs healthy volunteers.",null,"The Effect o f Hepatic Impairment on the Pharmacokinetics and Pharmacodynamics of Betrixiban, an Oral FXa Antagonist","17-022","Hepatic Impairment",{"$nulls":3},"Experimental","Cohort 1|Cohort 2|Cohort 3","Mild Impairment, Child-Pugh Category A|Moderate Impairment, Child-Pugh Category B|Essentially Healthy man or woman without liver disease matched to Cohorts 1 & 2 for age, sex and weight.","Drug","Betrixaban","80 mg capsule",null,"Cohort 1|Cohort 2|Cohort 3","\n\n 1. Cohorts 1 & 2: Man or a woman 18 to 70 with stable chronic hepatic impairment disease due to cirrhosis confirmed by biopsy, ultrasound, CT or MRI (Cohort 1 - Mild impairment, Child-Pugh Category A; Cohort 2 - Moderate Impairment, Child-Pugh Category B). Cohort 3: essentially healthy man or woman without liver disease whose sex, age and weight match patients in Cohorts 1 & 2 in order to result in similar average demographics.\n 2. Body Mass Index between 18 and 35 kg*m-2 and weighs at least 50 kg.\n 3. Contraception. Men must agree to acceptable methods of contraception. Women of child-bearing potential must agree to two acceptable forms of contraception. Post-menopausal women must have had no regular menstrual bleeding for at least one year prior to initial dosing and confirmed by an elevated plasma Follicle-stimulating hormone level test at screening for women not in receipt of hormone replacement therapy (HRT). Women who report surgical sterilization must have had the procedure at least six months prior to dosing, supported by clinical documentation.\n 4. The subject has clinical unremarkable medical history, physical examination, ECG, laboratory values and vital signs, as determined by the investigator. Subjects in Cohorts 1 & 2 may have: abnormal liver function tests, INR up to 2.2, PT up to 6 seconds over control, aPPT up to 45 seconds and platelets down to 45,000/uL.\n 5. The subject smokes <12 cigarettes per day or equivalent and agrees to no or reduced tobacco products while domiciled.\n 6. The subject is able to read and give written informed consent and signed the IRB approved consent form.\n 7. The subject has adequate venous access for blood sampling.\n\n","\n\n 1.  The subject has a history, symptoms of, or risk factors for bleeding or a stool specimen within 6 months of dosing positive for occult blood.\n 2.  The subject has an absolute/relative contraindication to anticoagulation due to: history of intracranial bleeding, severe active bleeding, recent brain, eye, or spinal cord surgery or major surgery within 6 months of dosing.\n 3.  The subject has a history of or risk factors for a hypercoagulable or thrombotic condition.\n 4.  The subject has a history of any clinically significant cardiac, endocrinologic, hematologic, hepatic (except for Cohorts 1 & 2), immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal or other major disease other than the underlying disease in Cohorts 1 & 2.\n 5.  The subject has a calculated creatinine clearance of <60mL/min as determined by Cockcroft-Gault method.\n 6.  Concomitant medication use: 1. For all subjects, illicit drugs, oral contraceptives, and hormone replacement therapy are excluded within 30 days prior to Day -1.\n      2. For all subjects, over the counter drugs, including dietary supplements and herbal products are excluded within 14 days prior to Day -1.\n      3. Subjects enrolled in Cohort 3 will be excluded if the subject has taken any prescription drugs in the 30 days prior to dosing. Furthermore, the subject will be excluded if he/she does not agree to refrain from concomitant drugs throughout the study unless medically necessary as determined by the Investigator.\n      4. Subjects enrolled in Cohort 1 and 2 may continue taking stable preexisting medications throughout the study with the exception of strong P-gp inhibitors. Strong P-gp inhibitors include but are not limited to: amiodarone, azithromycin, clarithromycin, erythromycin, ketoconazole, and verapamil. Prescribed stable acetaminophen use up to 2,000 mg per day is allowable. Any acetaminophen use with alcohol within 48 hours of dosing is prohibited. Furthermore, the subject will be excluded if he/she does not agree to refrain from additional concomitant drugs throughout the study unless medically necessary as determined by the Investigator.\n     \n     \n 7.  The subject has a history of severe trauma or bone fracture within 6 months prior to dosing; or planned surgery within 1 month after dosing.\n 8.  The subject has a history of blood donation of more than 500mL within 3 months prior to dosing.\n 9.  The subject has received an investigational drug product within 30 days or 5 half-lives of the investigational compound, whichever is greater, from Day -1.\n 10. The subject has positive screen for drugs of abuse at Day -1.\n 11. The subject does not agree to withhold from alcohol consumption from 48 hours prior to dosing through discharge.\n 12. The subject has a medical or surgical condition which may impair drug absorption.\n 13. The subject is pregnant or breastfeeding.\n 14. The subject has any condition which could interfere with or for which the treatment might interfere with the conduct of the study, or would, in the opinion of the Investigator, increase the risk of the subject's participation in the study.",{"$nulls":4},"Actual","2018-01-12","Actual","Actual","2018-01-16","Actual","2017-12-01","2017-12-07","2018-01-05","2018-09-20","No",null,"Interventional","Prevention","Parallel Assignment","None (Open Label)","Non-Randomized","18 Years","70 Years","All",null,"Yes",{"$nulls":4},"Yes","No",{"$nulls":19},"PK - Plasma half-life (t1/2)|PK - Tmax|PK - Cmax|PK - AUC (0-last)|PK - (AUC(0-âˆž)).|PK - Volume of distribution|PK - Total clearance","Plasma half-life (t1/2), distribution half-life and terminal half-life.|Time to maximum observed plasma concentration (Tmax).|Maximum observed plasma concentration (Cmax)|Area under the plasma concentration-time curve from 0 to last measurable concentration (AUC (0-last)).|Total area under the plasma concentration-time curve from time 0 to infinity (AUC(0-âˆž)).|Apparent volume of distribution (Vd/F).|Apparent total clearance (CL/F).","Day 1 through Day 6","Safety - Treatment Emergent AEs|Safety - Demographics|Safety - Vital Signs Temperature|Safety - Vital Signs Respiratory Rate|Safety - Vital Signs Heart Rate|Safety - Vital Signs Blood Pressure|Safety - 12 Lead ECG - PR|Safety - 12 Lead ECG - RR|Safety - 12 Lead ECG - WRS|Safety - 12 Lead ECG - QT|Safety - 12 Lead ECG - QTcF|Safety - 12 Lead ECG - QTcB|Safety - Physical Exam - Height|Safety - Physical Exam - Weight|Safety - Lab - Hematology - hemoglobin|Safety - Lab - Hematology - hematocrit|Safety - Lab - Hematology - white blood cell [WBC]|Safety - Lab - Hematology - Platelet Count|Safety - Lab - Hematology - Absolute Neutrophil Count|Safety - Lab - Hematology - Absolute Basophils|Safety - Lab - Hematology - Eosinophil's|Safety - Lab - Hematology - Lymphocytes|Safety - Lab - Hematology - Mean Corpuscular Hemoglobin|Safety - Lab - Hematology - Mean Corpuscular Hemoglobin Concentration|Safety - Lab - Hematology - Mean Corpuscular Hemoglobin Volume|Safety - Lab - Hematology - Monocytes|Safety - Lab - Hematology - Neutrophils|Safety - Lab - Hematology - Red Blood Cell Count|Safety - Lab - Hematology - Red Cell Distribution Width|Safety - Lab - Hematology - Reticulocyte|Safety- Lab - Coagulation - PT|Safety- Lab - Coagulation - INR|Safety- Lab - Coagulation - aPTT|Safety- Lab - Coagulation - Factor V Leiden|Safety - Lab - Serum Chemistry - Sodium|Safety - Lab - Serum Chemistry - Potassium|Safety - Lab - Serum Chemistry - Chloride|Safety - Lab - Serum Chemistry - Carbon Dioxide|Safety - Lab - Serum Chemistry - Glucose|Safety - Lab - Serum Chemistry - Blood Urea Nitrogen|Safety - Lab - Serum Chemistry - Creatinine|Safety - Lab - Serum Chemistry - AST|Safety - Lab - Serum Chemistry - ALT|Safety - Lab - Serum Chemistry - GGT|Safety - Lab - Serum Chemistry - Total Protein|Safety - Lab - Serum Chemistry - Albumin|Safety - Lab - Serum Chemistry - Alkaline Phosphatase|Safety - Lab - Serum Chemistry - Calcium|Safety - Lab - Serum Chemistry - Phosphorus|Safety - Lab - Serum Chemistry - Total Bilirubin|Safety - Lab - Serum Chemistry - Fractionated Bilirubin|Safety - Lab - Serum Chemistry - Uric Acid|Safety - Lab - Serum Chemistry - LDH|Safety - Lab - Urine toxicology Panel - Amphetamines|Safety - Lab - Urine toxicology Panel - Barbiturates|Safety - Lab - Urine toxicology Panel - Cannabinoids|Safety - Lab - Urine toxicology Panel - Cocaine|Safety - Lab - Urine toxicology Panel - Ethanol|Safety - Lab - Urine toxicology Panel - Opiates|Safety - Lab - Urinalysis - Specific Gravity|Safety - Lab - Urinalysis - pH|Safety - Lab - Urinalysis - Glucose|Safety - Lab - Urinalysis - Protein|Safety - Lab - Urinalysis - Hemoglobin|Safety - Lab - Urinalysis - Leukocyte esterase|Safety - Lab - Urinalysis - Nitrate|Safety - Urine Occult Blood Testing|Safety - Fecal Occult Blood Testing|Safety - Lab - Blood Virology - HIV I|Safety - Lab - Blood Virology - HIV II|Safety - Lab - Blood Virology - Hepatitis B|Safety - Lab - Blood Virology - Hepatitis C|Safety - Lab - Serum Pregnancy|PD - Anti-Factor Xa Concentration|PD - Thrombin Concentrations","Safety evaluation will study the adverse event (AE) profile|Safety will be evaluated by assessment of Demographics|Safety will be evaluated by assessment of Temperature - Celsius|Safety will be evaluated by assessment of Respiratory Rate - Breaths per Minute|Safety will be evaluated by assessment of Heart Rate - Beats per Minute|Safety will be evaluated by assessment of Blood Pressure - mmHg|Safety will be evaluated by assessment of 12 ECG - PR (ms)|Safety will be evaluated by assessment of 12 ECG - RR (ms)|Safety will be evaluated by assessment of 12 ECG - WRS (ms)|Safety will be evaluated by assessment of 12 ECG - QT (ms)|Safety will be evaluated by assessment of 12 ECG - QTcF (ms)|Safety will be evaluated by assessment of 12 ECG - QTcB (ms)|Safety will be evaluated by assessment Physical Exam - Height (centimeters)|Safety will be evaluated by assessment Physical Exam - Weight (kilogram)|Safety will be evaluated by analyzing Hematology - hemoglobin (g/dL)|Safety will be evaluated by analyzing Hematology - hematocrit (%)|Safety will be evaluated by analyzing Hematology - WBC (K/UL)|Safety will be evaluated by analyzing Platelet Count (Plt/mL)|Safety will be evaluated by analyzing Absolute Neutrophil Count (K/UL)|Safety will be evaluated by analyzing Absolute Basophils (K/UL)|Safety will be evaluated by analyzing Eosinophil's (K/UL)|Safety will be evaluated by analyzing Lymphocytes (K/UL)|Safety will be evaluated by analyzing Mean Corpuscular Hemoglobin (PG)|Safety will be evaluated by analyzing Mean Corpuscular Hemoglobin Concentration (g/dL)|Safety will be evaluated by analyzing Mean Corpuscular Hemoglobin Volume (FL)|Safety will be evaluated by analyzing Monocytes (K/UL)|Safety will be evaluated by analyzing Neutrophils (K/UL)|Safety will be evaluated by analyzing Red Blood Cell Count (MIL/UL)|Safety will be evaluated by analyzing Red Cell Distribution Width (%)|Safety will be evaluated by analyzing Reticulocyte (K/UL)|Safety will be evaluated by analyzing Coagulation - PT (seconds)|Safety will be evaluated by analyzing Coagulation - INR (no unit)|Safety will be evaluated by analyzing Coagulation - aPTT (seconds)|Safety will be evaluated by analyzing Coagulation - Factor V Leiden (positive/negative)|Safety will be evaluated by analyzing Serum Chemistry - Sodium (mEq/L)|Safety will be evaluated by analyzing Serum Chemistry - Potassium (mEq/L)|Safety will be evaluated by analyzing Serum Chemistry - Chloride (mEq/L)|Safety will be evaluated by analyzing Serum Chemistry - Carbon Dioxide (mEq/L)|Safety will be evaluated by analyzing Serum Chemistry - Glucose (mg/dL)|Safety will be evaluated by analyzing Serum Chemistry - Blood Urea Nitrogen (mg/dL)|Safety will be evaluated by analyzing Serum Chemistry - Creatinine (mg/dL)|Safety will be evaluated by analyzing Serum Chemistry - AST (U/L)|Safety will be evaluated by analyzing Serum Chemistry - ALT (U/L)|Safety will be evaluated by analyzing Serum Chemistry - GGT (U/L)|Safety will be evaluated by analyzing Serum Chemistry - Total Protein (g/dL)|Safety will be evaluated by analyzing Serum Chemistry - Albumin(g/dL)|Safety will be evaluated by analyzing Serum Chemistry - Alkaline Phosphatase (U/L)|Safety will be evaluated by analyzing Serum Chemistry - Calcium (mg/dL)|Safety will be evaluated by analyzing Serum Chemistry - Phosphorus (mg/dL)|Safety will be evaluated by analyzing Serum Chemistry - Total Bilirubin (mg/dL)|Safety will be evaluated by analyzing Serum Chemistry - Fractionated Bilirubin(mg/dL)|Safety will be evaluated by analyzing Serum Chemistry - Uric Acid (mg/dL)|Safety will be evaluated by analyzing Serum Chemistry LDH (U/L)|Safety will be evaluated by analyzing Urine toxicology Panel - Amphetamines (NG/ML)|Safety will be evaluated by analyzing Urine toxicology Panel - Barbiturates (NG/ML)|Safety will be evaluated by analyzing Urine toxicology Panel - Cannabinoids (NG/ML)|Safety will be evaluated by analyzing Urine toxicology Panel - Cocaine (NG/ML)|Safety will be evaluated by analyzing Urine toxicology Panel - Ethanol (MG/DL)|Safety will be evaluated by analyzing Urine toxicology Panel - Opiates (NG/ML)|Safety will be evaluated by analyzing Urinalysis - Specific Gravity (no unit)|Safety will be evaluated by analyzing Urinalysis - pH (no unit)|Safety will be evaluated by analyzing Urinalysis - Glucose (no unit)|Safety will be evaluated by analyzing Urinalysis - Protein (no unit)|Safety will be evaluated by analyzing Urinalysis - Hemoglobin (no unit)|Safety will be evaluated by analyzing Urinalysis - Leukocyte esterase (no unit)|Safety will be evaluated by analyzing Urinalysis - Nitrate (no unit)|Safety will be evaluated by assessment of Urine Occult Blood Testing (positive/negative)|Safety will be evaluated by assessment of Fecal Occult Blood Testing (positive/negative)|Safety will be evaluated by analyzing Blood Virology - HIV I (positive/negative)|Safety will be evaluated by analyzing Blood Virology - HIV II (positive/negative)|Safety will be evaluated by analyzing Blood Virology - Hepatitis B (positive/negative)|Safety will be evaluated by analyzing Blood Virology - Hepatitis C (positive/negative)|Safety will be evaluated by analyzing Serum Pregnancy|Anti-fXa will be analyzed for changes/percent changes from baseline over time.|Thrombin will be analyzed for changes/percent changes from baseline over time.","Day -1 through up to Day 21|Day -30 through Day -2 (Screening)|Day -30 through up to Day 21|Day -30 through Day -1|Day -30 through Day -2 (screening)|Day-30 through Day -2 (Screening)|Day 1 through Day 6",{"$nulls":3},"Hialeah, Florida, United States, 33014","Florida","United States","Clinical Pharmacology Of Miami",{"$nulls":4},"2018-09-20","2020-05-25T16:36:28.932","2020-05-26T17:10:42.972","NCT03397888"]
["5ecbf40dfe30261b1a048237","NCT03397888","2018-09-25","Portola","PTLA","Completed","The Effect o f Hepatic Impairment on the Pharmacokinetics and Pharmacodynamics of Betrixiban, an Oral FXa Antagonist","Betrixaban","FXa Inhibitor","No",null,"No",null,"Phase 1",3,32,"Actual","2017-11-16","2018-01-16","AUC","Area Under The Curve",{"$nulls":3},"Single center, prospective open label PK and PD study of betrixaban in subjects with mild and moderate hepatic impairment vs healthy volunteers.",null,"The Effect o f Hepatic Impairment on the Pharmacokinetics and Pharmacodynamics of Betrixiban, an Oral FXa Antagonist","17-022","Hepatic Impairment",{"$nulls":3},"Experimental","Cohort 1|Cohort 2|Cohort 3","Mild Impairment, Child-Pugh Category A|Moderate Impairment, Child-Pugh Category B|Essentially Healthy man or woman without liver disease matched to Cohorts 1 & 2 for age, sex and weight.","Drug","Betrixaban","80 mg capsule",null,"Cohort 1|Cohort 2|Cohort 3","\n\n 1. Cohorts 1 & 2: Man or a woman 18 to 70 with stable chronic hepatic impairment disease due to cirrhosis confirmed by biopsy, ultrasound, CT or MRI (Cohort 1 - Mild impairment, Child-Pugh Category A; Cohort 2 - Moderate Impairment, Child-Pugh Category B). Cohort 3: essentially healthy man or woman without liver disease whose sex, age and weight match patients in Cohorts 1 & 2 in order to result in similar average demographics.\n 2. Body Mass Index between 18 and 35 kg*m-2 and weighs at least 50 kg.\n 3. Contraception. Men must agree to acceptable methods of contraception. Women of child-bearing potential must agree to two acceptable forms of contraception. Post-menopausal women must have had no regular menstrual bleeding for at least one year prior to initial dosing and confirmed by an elevated plasma Follicle-stimulating hormone level test at screening for women not in receipt of hormone replacement therapy (HRT). Women who report surgical sterilization must have had the procedure at least six months prior to dosing, supported by clinical documentation.\n 4. The subject has clinical unremarkable medical history, physical examination, ECG, laboratory values and vital signs, as determined by the investigator. Subjects in Cohorts 1 & 2 may have: abnormal liver function tests, INR up to 2.2, PT up to 6 seconds over control, aPPT up to 45 seconds and platelets down to 45,000/uL.\n 5. The subject smokes <12 cigarettes per day or equivalent and agrees to no or reduced tobacco products while domiciled.\n 6. The subject is able to read and give written informed consent and signed the IRB approved consent form.\n 7. The subject has adequate venous access for blood sampling.\n\n","\n\n 1.  The subject has a history, symptoms of, or risk factors for bleeding or a stool specimen within 6 months of dosing positive for occult blood.\n 2.  The subject has an absolute/relative contraindication to anticoagulation due to: history of intracranial bleeding, severe active bleeding, recent brain, eye, or spinal cord surgery or major surgery within 6 months of dosing.\n 3.  The subject has a history of or risk factors for a hypercoagulable or thrombotic condition.\n 4.  The subject has a history of any clinically significant cardiac, endocrinologic, hematologic, hepatic (except for Cohorts 1 & 2), immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal or other major disease other than the underlying disease in Cohorts 1 & 2.\n 5.  The subject has a calculated creatinine clearance of <60mL/min as determined by Cockcroft-Gault method.\n 6.  Concomitant medication use: 1. For all subjects, illicit drugs, oral contraceptives, and hormone replacement therapy are excluded within 30 days prior to Day -1.\n      2. For all subjects, over the counter drugs, including dietary supplements and herbal products are excluded within 14 days prior to Day -1.\n      3. Subjects enrolled in Cohort 3 will be excluded if the subject has taken any prescription drugs in the 30 days prior to dosing. Furthermore, the subject will be excluded if he/she does not agree to refrain from concomitant drugs throughout the study unless medically necessary as determined by the Investigator.\n      4. Subjects enrolled in Cohort 1 and 2 may continue taking stable preexisting medications throughout the study with the exception of strong P-gp inhibitors. Strong P-gp inhibitors include but are not limited to: amiodarone, azithromycin, clarithromycin, erythromycin, ketoconazole, and verapamil. Prescribed stable acetaminophen use up to 2,000 mg per day is allowable. Any acetaminophen use with alcohol within 48 hours of dosing is prohibited. Furthermore, the subject will be excluded if he/she does not agree to refrain from additional concomitant drugs throughout the study unless medically necessary as determined by the Investigator.\n     \n     \n 7.  The subject has a history of severe trauma or bone fracture within 6 months prior to dosing; or planned surgery within 1 month after dosing.\n 8.  The subject has a history of blood donation of more than 500mL within 3 months prior to dosing.\n 9.  The subject has received an investigational drug product within 30 days or 5 half-lives of the investigational compound, whichever is greater, from Day -1.\n 10. The subject has positive screen for drugs of abuse at Day -1.\n 11. The subject does not agree to withhold from alcohol consumption from 48 hours prior to dosing through discharge.\n 12. The subject has a medical or surgical condition which may impair drug absorption.\n 13. The subject is pregnant or breastfeeding.\n 14. The subject has any condition which could interfere with or for which the treatment might interfere with the conduct of the study, or would, in the opinion of the Investigator, increase the risk of the subject's participation in the study.",{"$nulls":4},"Actual","2018-01-12","Actual","Actual","2018-01-16","Actual","2017-12-01","2017-12-07","2018-01-05","2018-09-24","No",null,"Interventional","Prevention","Parallel Assignment","None (Open Label)","Non-Randomized","18 Years","70 Years","All",null,"Yes",{"$nulls":4},"Yes","No",{"$nulls":19},"PK - Plasma half-life (t1/2)|PK - Tmax|PK - Cmax|PK - AUC (0-last)|PK - (AUC(0-âˆž)).|PK - Volume of distribution|PK - Total clearance","Plasma half-life (t1/2), distribution half-life and terminal half-life.|Time to maximum observed plasma concentration (Tmax).|Maximum observed plasma concentration (Cmax)|Area under the plasma concentration-time curve from 0 to last measurable concentration (AUC (0-last)).|Total area under the plasma concentration-time curve from time 0 to infinity (AUC(0-âˆž)).|Apparent volume of distribution (Vd/F).|Apparent total clearance (CL/F).","Day 1 through Day 6","Safety - Treatment Emergent AEs|Safety - Demographics|Safety - Vital Signs Temperature|Safety - Vital Signs Respiratory Rate|Safety - Vital Signs Heart Rate|Safety - Vital Signs Blood Pressure|Safety - 12 Lead ECG - PR|Safety - 12 Lead ECG - RR|Safety - 12 Lead ECG - WRS|Safety - 12 Lead ECG - QT|Safety - 12 Lead ECG - QTcF|Safety - 12 Lead ECG - QTcB|Safety - Physical Exam - Height|Safety - Physical Exam - Weight|Safety - Lab - Hematology - hemoglobin|Safety - Lab - Hematology - hematocrit|Safety - Lab - Hematology - white blood cell [WBC]|Safety - Lab - Hematology - Platelet Count|Safety - Lab - Hematology - Absolute Neutrophil Count|Safety - Lab - Hematology - Absolute Basophils|Safety - Lab - Hematology - Eosinophil's|Safety - Lab - Hematology - Lymphocytes|Safety - Lab - Hematology - Mean Corpuscular Hemoglobin|Safety - Lab - Hematology - Mean Corpuscular Hemoglobin Concentration|Safety - Lab - Hematology - Mean Corpuscular Hemoglobin Volume|Safety - Lab - Hematology - Monocytes|Safety - Lab - Hematology - Neutrophils|Safety - Lab - Hematology - Red Blood Cell Count|Safety - Lab - Hematology - Red Cell Distribution Width|Safety - Lab - Hematology - Reticulocyte|Safety- Lab - Coagulation - PT|Safety- Lab - Coagulation - INR|Safety- Lab - Coagulation - aPTT|Safety- Lab - Coagulation - Factor V Leiden|Safety - Lab - Serum Chemistry - Sodium|Safety - Lab - Serum Chemistry - Potassium|Safety - Lab - Serum Chemistry - Chloride|Safety - Lab - Serum Chemistry - Carbon Dioxide|Safety - Lab - Serum Chemistry - Glucose|Safety - Lab - Serum Chemistry - Blood Urea Nitrogen|Safety - Lab - Serum Chemistry - Creatinine|Safety - Lab - Serum Chemistry - AST|Safety - Lab - Serum Chemistry - ALT|Safety - Lab - Serum Chemistry - GGT|Safety - Lab - Serum Chemistry - Total Protein|Safety - Lab - Serum Chemistry - Albumin|Safety - Lab - Serum Chemistry - Alkaline Phosphatase|Safety - Lab - Serum Chemistry - Calcium|Safety - Lab - Serum Chemistry - Phosphorus|Safety - Lab - Serum Chemistry - Total Bilirubin|Safety - Lab - Serum Chemistry - Fractionated Bilirubin|Safety - Lab - Serum Chemistry - Uric Acid|Safety - Lab - Serum Chemistry - LDH|Safety - Lab - Urine toxicology Panel - Amphetamines|Safety - Lab - Urine toxicology Panel - Barbiturates|Safety - Lab - Urine toxicology Panel - Cannabinoids|Safety - Lab - Urine toxicology Panel - Cocaine|Safety - Lab - Urine toxicology Panel - Ethanol|Safety - Lab - Urine toxicology Panel - Opiates|Safety - Lab - Urinalysis - Specific Gravity|Safety - Lab - Urinalysis - pH|Safety - Lab - Urinalysis - Glucose|Safety - Lab - Urinalysis - Protein|Safety - Lab - Urinalysis - Hemoglobin|Safety - Lab - Urinalysis - Leukocyte esterase|Safety - Lab - Urinalysis - Nitrate|Safety - Urine Occult Blood Testing|Safety - Fecal Occult Blood Testing|Safety - Lab - Blood Virology - HIV I|Safety - Lab - Blood Virology - HIV II|Safety - Lab - Blood Virology - Hepatitis B|Safety - Lab - Blood Virology - Hepatitis C|Safety - Lab - Serum Pregnancy|PD - Anti-Factor Xa Concentration|PD - Thrombin Concentrations","Safety evaluation will study the adverse event (AE) profile|Safety will be evaluated by assessment of Demographics|Safety will be evaluated by assessment of Temperature - Celsius|Safety will be evaluated by assessment of Respiratory Rate - Breaths per Minute|Safety will be evaluated by assessment of Heart Rate - Beats per Minute|Safety will be evaluated by assessment of Blood Pressure - mmHg|Safety will be evaluated by assessment of 12 ECG - PR (ms)|Safety will be evaluated by assessment of 12 ECG - RR (ms)|Safety will be evaluated by assessment of 12 ECG - WRS (ms)|Safety will be evaluated by assessment of 12 ECG - QT (ms)|Safety will be evaluated by assessment of 12 ECG - QTcF (ms)|Safety will be evaluated by assessment of 12 ECG - QTcB (ms)|Safety will be evaluated by assessment Physical Exam - Height (centimeters)|Safety will be evaluated by assessment Physical Exam - Weight (kilogram)|Safety will be evaluated by analyzing Hematology - hemoglobin (g/dL)|Safety will be evaluated by analyzing Hematology - hematocrit (%)|Safety will be evaluated by analyzing Hematology - WBC (K/UL)|Safety will be evaluated by analyzing Platelet Count (Plt/mL)|Safety will be evaluated by analyzing Absolute Neutrophil Count (K/UL)|Safety will be evaluated by analyzing Absolute Basophils (K/UL)|Safety will be evaluated by analyzing Eosinophil's (K/UL)|Safety will be evaluated by analyzing Lymphocytes (K/UL)|Safety will be evaluated by analyzing Mean Corpuscular Hemoglobin (PG)|Safety will be evaluated by analyzing Mean Corpuscular Hemoglobin Concentration (g/dL)|Safety will be evaluated by analyzing Mean Corpuscular Hemoglobin Volume (FL)|Safety will be evaluated by analyzing Monocytes (K/UL)|Safety will be evaluated by analyzing Neutrophils (K/UL)|Safety will be evaluated by analyzing Red Blood Cell Count (MIL/UL)|Safety will be evaluated by analyzing Red Cell Distribution Width (%)|Safety will be evaluated by analyzing Reticulocyte (K/UL)|Safety will be evaluated by analyzing Coagulation - PT (seconds)|Safety will be evaluated by analyzing Coagulation - INR (no unit)|Safety will be evaluated by analyzing Coagulation - aPTT (seconds)|Safety will be evaluated by analyzing Coagulation - Factor V Leiden (positive/negative)|Safety will be evaluated by analyzing Serum Chemistry - Sodium (mEq/L)|Safety will be evaluated by analyzing Serum Chemistry - Potassium (mEq/L)|Safety will be evaluated by analyzing Serum Chemistry - Chloride (mEq/L)|Safety will be evaluated by analyzing Serum Chemistry - Carbon Dioxide (mEq/L)|Safety will be evaluated by analyzing Serum Chemistry - Glucose (mg/dL)|Safety will be evaluated by analyzing Serum Chemistry - Blood Urea Nitrogen (mg/dL)|Safety will be evaluated by analyzing Serum Chemistry - Creatinine (mg/dL)|Safety will be evaluated by analyzing Serum Chemistry - AST (U/L)|Safety will be evaluated by analyzing Serum Chemistry - ALT (U/L)|Safety will be evaluated by analyzing Serum Chemistry - GGT (U/L)|Safety will be evaluated by analyzing Serum Chemistry - Total Protein (g/dL)|Safety will be evaluated by analyzing Serum Chemistry - Albumin(g/dL)|Safety will be evaluated by analyzing Serum Chemistry - Alkaline Phosphatase (U/L)|Safety will be evaluated by analyzing Serum Chemistry - Calcium (mg/dL)|Safety will be evaluated by analyzing Serum Chemistry - Phosphorus (mg/dL)|Safety will be evaluated by analyzing Serum Chemistry - Total Bilirubin (mg/dL)|Safety will be evaluated by analyzing Serum Chemistry - Fractionated Bilirubin(mg/dL)|Safety will be evaluated by analyzing Serum Chemistry - Uric Acid (mg/dL)|Safety will be evaluated by analyzing Serum Chemistry LDH (U/L)|Safety will be evaluated by analyzing Urine toxicology Panel - Amphetamines (NG/ML)|Safety will be evaluated by analyzing Urine toxicology Panel - Barbiturates (NG/ML)|Safety will be evaluated by analyzing Urine toxicology Panel - Cannabinoids (NG/ML)|Safety will be evaluated by analyzing Urine toxicology Panel - Cocaine (NG/ML)|Safety will be evaluated by analyzing Urine toxicology Panel - Ethanol (MG/DL)|Safety will be evaluated by analyzing Urine toxicology Panel - Opiates (NG/ML)|Safety will be evaluated by analyzing Urinalysis - Specific Gravity (no unit)|Safety will be evaluated by analyzing Urinalysis - pH (no unit)|Safety will be evaluated by analyzing Urinalysis - Glucose (no unit)|Safety will be evaluated by analyzing Urinalysis - Protein (no unit)|Safety will be evaluated by analyzing Urinalysis - Hemoglobin (no unit)|Safety will be evaluated by analyzing Urinalysis - Leukocyte esterase (no unit)|Safety will be evaluated by analyzing Urinalysis - Nitrate (no unit)|Safety will be evaluated by assessment of Urine Occult Blood Testing (positive/negative)|Safety will be evaluated by assessment of Fecal Occult Blood Testing (positive/negative)|Safety will be evaluated by analyzing Blood Virology - HIV I (positive/negative)|Safety will be evaluated by analyzing Blood Virology - HIV II (positive/negative)|Safety will be evaluated by analyzing Blood Virology - Hepatitis B (positive/negative)|Safety will be evaluated by analyzing Blood Virology - Hepatitis C (positive/negative)|Safety will be evaluated by analyzing Serum Pregnancy|Anti-fXa will be analyzed for changes/percent changes from baseline over time.|Thrombin will be analyzed for changes/percent changes from baseline over time.","Day -1 through up to Day 21|Day -30 through Day -2 (Screening)|Day -30 through up to Day 21|Day -30 through Day -1|Day -30 through Day -2 (screening)|Day-30 through Day -2 (Screening)|Day 1 through Day 6",{"$nulls":3},"Hialeah, Florida, United States, 33014","Florida","United States","Clinical Pharmacology Of Miami",{"$nulls":4},"2018-09-24","2020-05-25T16:36:29.541","2020-05-26T17:10:42.972","NCT03397888"]
["5ecbf40dfeab101b15530868","NCT03398135","2018-01-12","AbbVie","ABBV","Not yet recruiting","A Study to Assess the Efficacy and Safety of Risankizumab in Subjects With Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065","Risankizumab","IL23 Inhibitor","Yes","['Risankizumab']","No",null,"Phase 3",6,760,"Anticipated","2018-06-24","2022-08-06",{"$nulls":5},"The purpose of this study is to evaluate safety and efficacy of risankizumab in subjects with ulcerative colitis (UC) in subjects who responded to induction treatment with rizankizumab in a prior AbbVie study of risankizumab in UC.\n\nThis study consists of three sub-studies: Substudy 1 is a 52-week, randomized, double-blind, placebo-controlled maintenance study; Substudy 2 is 52-week, randomized, exploratory maintenance study; and Substudy 3 is an open-label long-term extension study for subjects who completed Substudy 1 or 2.",null,"A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects With Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065","M16-066","Ulcerative Colitis","Colitis|Colitis, Ulcerative","Gastrointestinal Diseases","Gastrointestinal","Placebo Comparator|Experimental","Substudy 1: Double-blind Placebo|Substudy 1: Double-blind Risankizumab Dose 1|Substudy 1: Double-blind Risankizumab Dose 2|Substudy 2: Open-label Risankizumab Dose 1|Substudy 2: Open-label Risankizumab Dose 2|Substudy 3: Open-label Extension Risankizumab","Participants randomized to receive placebo for risankizumab administered by subcutaneous (SC) injection.|Participants randomized to receive risankizumab dose 1 administered by subcutaneous (SC) injection.|Participants randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection.|Participants who completed Sub-study 1 or 2 receive open-label risankizumab in Sub-study 3.","Drug","placebo for risankizumab|risankizumab","subcutaneous (SC) injection","ABBV-066 | BI 655066","Substudy 1: Double-blind Placebo|Substudy 1: Double-blind Risankizumab Dose 1|Substudy 1: Double-blind Risankizumab Dose 2|Substudy 2: Open-label Risankizumab Dose 1|Substudy 2: Open-label Risankizumab Dose 2|Substudy 3: Open-label Extension Risankizumab","\n\n- Subjects who have completed Study M16-065 or Study M16-067 and have achieved clinical response\n\n","\n\n * Subjects who have a known hypersensitivity to risankizumab or the excipients of any of the study drugs or the ingredients of chinese hamster ovary (CHO) or had an adverse event (AE) during Studies M16-065 or M16-067 that in the Investigator's judgment makes the subject unsuitable for this study\n * Subject is considered by the Investigator, for any reason, to be an unsuitable candidate for the study\n * Subject is not in compliance with prior and concomitant medication requirements throughout Studies M16-065 and M16-067",{"$nulls":4},"Actual","2018-01-12","Actual","Anticipated","2023-07-25","Anticipated","2018-01-01","2018-01-08","2018-01-08","2018-01-08","Yes","ABBV-066\nBI 655066","Interventional","Treatment","Parallel Assignment","Triple (Participant, Investigator, Outcomes Assessor)","Randomized","16 Years","80 Years","All",null,"No","Undecided",{"$nulls":3},"Yes","No",{"$nulls":17},"2016-004676-22","EudraCT Number","Percentage of participants with clinical remission per adapted Mayo Score at Week 52","Clinical remission per Adapted Mayo Score.","Week 52","Percentage of participants with endoscopic improvement at Week 52|Percentage of participants with clinical remission per full Mayo Score at Week 52 in subjects with a full Mayo Score of 6 to 12 at Baseline (of Induction)|Percentage of participants who discontinued corticosteroid use, remained corticosteroid free for 90 days, and achieved clinical remission per adapted Mayo Score at Week 52 in subjects taking steroids at Baseline (of induction).|Percentage of participants with clinical remission per adapted Mayo Score at Week 52 in subjects with a clinical remission at Week 0|Percentage of participants who discontinued corticosteroid use at Week 52 in subjects who were taking steroids at Baseline (of induction)|Percentage of participants with endoscopic improvement at Week 52 in participants with endoscopic improvement at Week 0|Percentage of participants with clinical response per adapted Mayo score at Week 52|Percentage of participants with endoscopic remission at Week 52|Percentage of participants with hospitalization through Week 52|Ulcerative Colititis Symptom Questionnaire (UC-SQ): Change from Week 0 to Week 52|Percentage of participants with histologic remission at Week 52|Percentage of participants with mucosal healing at Week 52|Inflammatory Bowel Disease Questionnaire (IBDQ): Change from Week 0 to Week 52|Percentage of participants with Ulcerative Colitis (UC)-related surgeries through Week 52|36-Item Short Form Health Status Survey (SF-36): Change from Week 0 to Week 52|Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue): Change from Week 0 to Week 52","Endoscopic improvement per endoscopy subscore.|Clinical remission per full Mayo Score.|Clinical remission per Adapted Mayo Score.|Participants who discontinued corticosteroid use.|Clinical response per Adapted Mayo score.|Endoscopic remission per endoscopy subscore.|Participants with an event that results in admission to the hospital.|The UC-SQ is a patient questionnaire to assess severity of ulcerative colitis symptoms.|Histologic remission per Geboes Score.|Mucosal healing defined as endoscopic and histologic remission.|The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.|Participants who underwent surgery related to UC.|The SF-36 is an indicator of overall health status.|The FACIT-Fatigue is a validated tool that measures an individual's level of fatigue during their usual daily activities over the past week.","Week 52|52 weeks|Week 0, Week 52","abbvieclinicaltrials@abbvie.com","AbbVie_Call Center","847.283.8955",{"$nulls":7},"AbbVie Inc","2018-01-08","2020-05-25T16:36:29.759","2020-05-26T17:10:42.972","NCT03398135"]
["5ecbf40d11702c1b1b916a48","NCT03398135","2018-04-30","AbbVie","ABBV","Not yet recruiting","A Study to Assess the Efficacy and Safety of Risankizumab in Subjects With Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065","Risankizumab","IL23 Inhibitor","Yes","['Risankizumab']","No",null,"Phase 3",6,760,"Anticipated","2018-07-23","2022-12-04",{"$nulls":5},"The purpose of this study is to evaluate safety and efficacy of risankizumab in subjects with ulcerative colitis (UC) in subjects who responded to induction treatment with rizankizumab in a prior AbbVie study of risankizumab in UC.\n\nThis study consists of three sub-studies: Substudy 1 is a 52-week, randomized, double-blind, placebo-controlled maintenance study; Substudy 2 is 52-week, randomized, exploratory maintenance study; and Substudy 3 is an open-label long-term extension study for subjects who completed Substudy 1 or 2.",null,"A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects With Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065","M16-066","Ulcerative Colitis (UC)","Colitis|Colitis, Ulcerative","Gastrointestinal Diseases","Gastrointestinal","Experimental|Placebo Comparator","Substudy 2: Open-label Risankizumab Dose 1|Substudy 1: Double-blind Risankizumab Dose 2|Substudy 2: Open-label Risankizumab Dose 2|Substudy 3: Open-label Extension Risankizumab|Substudy 1: Double-blind Placebo|Substudy 1: Double-blind Risankizumab Dose 1","Participants randomized to receive risankizumab dose 1 administered by subcutaneous (SC) injection.|Participants randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection.|Participants who completed Sub-study 1 or 2 receive open-label risankizumab in Sub-study 3.|Participants randomized to receive placebo for risankizumab administered by subcutaneous (SC) injection.","Drug","risankizumab|placebo for risankizumab","subcutaneous (SC) injection","ABBV-066 | BI 655066","Substudy 2: Open-label Risankizumab Dose 1|Substudy 1: Double-blind Risankizumab Dose 2|Substudy 2: Open-label Risankizumab Dose 2|Substudy 3: Open-label Extension Risankizumab|Substudy 1: Double-blind Placebo|Substudy 1: Double-blind Risankizumab Dose 1","\n\n * Subjects who have completed Study M16-065 or Study M16-067 and have achieved clinical response\n\n","\n\n * Subjects who have a known hypersensitivity to risankizumab or the excipients of any of the study drugs or the ingredients of chinese hamster ovary (CHO) or had an adverse event (AE) during Studies M16-065 or M16-067 that in the Investigator's judgment makes the subject unsuitable for this study\n * Subject is considered by the Investigator, for any reason, to be an unsuitable candidate for the study\n * Subject is not in compliance with prior and concomitant medication requirements throughout Studies M16-065 and M16-067",{"$nulls":4},"Actual","2018-01-12","Actual","Anticipated","2023-06-20","Anticipated","2018-04-01","2018-01-08","2018-01-08","2018-04-27","Yes","ABBV-066\nBI 655066","Interventional","Treatment","Parallel Assignment","Triple (Participant, Investigator, Outcomes Assessor)","Randomized","16 Years","80 Years","All",null,"No","Undecided",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2016-004676-22","EudraCT Number","Percentage of participants with clinical remission per adapted Mayo Score at Week 52","Clinical remission per Adapted Mayo Score.","Week 52","Percentage of participants with clinical remission per adapted Mayo Score at Week 52 in subjects with a clinical remission at Week 0|Percentage of participants who discontinued corticosteroid use at Week 52 in subjects who were taking steroids at Baseline (of induction)|Percentage of participants who discontinued corticosteroid use, remained corticosteroid free for 90 days, and achieved clinical remission per adapted Mayo Score at Week 52 in subjects taking steroids at Baseline (of induction).|Percentage of participants with endoscopic remission at Week 52|Ulcerative Colitis Symptom Questionnaire (UC-SQ): Change from Week 0 to Week 52|Percentage of participants with Ulcerative Colitis (UC)-related surgeries through Week 52|Percentage of participants with hospitalization through Week 52|36-Item Short Form Health Status Survey (SF-36): Change from Week 0 to Week 52|Inflammatory Bowel Disease Questionnaire (IBDQ): Change from Week 0 to Week 52|Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue): Change from Week 0 to Week 52|Percentage of participants with endoscopic improvement at Week 52|Percentage of participants with clinical remission per full Mayo Score at Week 52 in subjects with a full Mayo Score of 6 to 12 at Baseline (of Induction)|Percentage of participants with endoscopic improvement at Week 52 in participants with endoscopic improvement at Week 0|Percentage of participants with clinical response per adapted Mayo score at Week 52|Percentage of participants with histologic remission at Week 52|Percentage of participants with mucosal healing at Week 52","Clinical remission per Adapted Mayo Score.|Participants who discontinued corticosteroid use.|Endoscopic remission per endoscopy subscore.|The UC-SQ is a patient questionnaire to assess severity of ulcerative colitis symptoms.|Participants who underwent surgery related to UC.|Participants with an event that results in admission to the hospital.|The SF-36 is an indicator of overall health status.|The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.|The FACIT-Fatigue is a validated tool that measures an individual's level of fatigue during their usual daily activities over the past week.|Endoscopic improvement per endoscopy subscore.|Clinical remission per full Mayo Score.|Clinical response per Adapted Mayo score.|Histologic remission per Geboes Score.|Mucosal healing defined as endoscopic and histologic remission.","Week 52|Week 0, Week 52|52 weeks","abbvieclinicaltrials@abbvie.com","ABBVIE CALL CENTER","847.283.8955","Buenos Aires, Argentina, 1431 Hosp Privado Ctr Med CordobaCordoba, Argentina, 5016 Sanatorio GuemesCuidad Autonoma De Buenosaires, Argentina, C1180Aad Instituto Medico CerQuilmes, Argentina, 1878 Sanatorio 9 De Julio S.A.San Miguel De Tucuman, Argentina, 4000 Hopital CentenarioSanta Fe, Argentina, 2000|Graz, Austria, 8036 Lkh Salzburg And ParacelsusSalzburg, Austria, 5020|St. PÃ¶lten, Niederosterreich, Austria, 3100|Vienna, Wein, Austria, 1090|Brussels, Bruxelles-Capitale, Belgium, 1070 Cliniques Universitaires Saint LucWoluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200|Liege, Liege, Belgium, 4000|Gent, Oost-Vlaanderen, Belgium, 9000|Jette, Brussels, Belgium, 1090 Uz LeuvenLeuven, Belgium, 3000 Clinique St JosephLiege, Belgium, 4000 Az-DeltaRoeselare, Belgium, 8800 Chu Dinant Godinne - Ucl NamurYvoir, Belgium, 5530|Plovdiv, Bulgaria, 4001 Ii Mhat - SofiaSofia, Bulgaria, 1202 Acibadem City Clinic TokudaSofia, Bulgaria, 1407 Mbal TrakiaStara Zagora, Bulgaria, 6004|Calgary, Alberta, Canada, T2N 4Z6 South Edmonton GastroenterologEdmonton, Alberta, Canada, T6L 6K3|New Westminster, British Columbia, Canada, V3L 3W4 Gi Research InstituteVancouver, British Columbia, Canada, V6Z 2K5 Percuro ClinicVictoria, British Columbia, Canada, V8R6R3|Santiago, Chile, 8207257 Hospital San Juan De DiosSantiago, Chile, 8350488 Hospital Clinico UniversidadSantiago, Chile, 8380456 Hospital Las HiguerasTalcahuano, Chile|ViÃ±a Del Mar, ValparaÃ­so, Chile, 2540488|Zagreb, Grad Zagreb, Croatia, 10000 Klinicki Bolnicki Centar ZagrebZagreb, Grad Zagreb, Croatia, 10000|Split, Croatia, 21000|Osijek, Osjecko-Baranjska Zupanija, Croatia, 31000|Hradec Kralove, Czechia, 500 12 Nemocnice Pardubickeho Kraje,Pardubice, Czechia, 53203|Olomouc, Olomoucky Kraj, Czechia, 779 00|Praha, Praha 5, Czechia, 150 00|Aarhus C, Midtjylland, Denmark, 8000|Roskilde, SjÃ¦lland, Denmark, 4000|Nyborg, Syddanmark, Denmark, 5800|Alexandria, Egypt, 21131 Nat Hep & Trop Med Res InstCairo, Egypt, 1141 Air Force Specialized HospitalCairo, Egypt National Liver InstituteMenoufiya, Egypt, 35111|Athens, Greece, 11527 Agios Panteleimon General HospPireaus, Greece, 18454 Theageneio Cancer HospitalThessaloniki, Greece, 546 39|Heraklion, Kriti, Greece, 711 10|GyÃ¶ngyÃ¶s, Heves, Hungary, 3200|Debrecen, Hungary, 4031 Miskolci Semmelweis Korhaz EsKecskemet, Hungary, 6000 Tolna Megyei Onkormanyzat BalaSzekszard, Hungary, 7100|Catanzaro, Calabria, Italy, 88100|Bologna, Emilia-Romagna, Italy, 40138|Genoa, Italy, 16132 Azienda Ospedaliera Ospedale NMilano, Italy, 20162 Azienda Ospedaliera Luigi SaccMilan, Italy, 20157 Policlinico Tor VergataRome, Italy, 00133 Uoc Medicina Interna E GastroeRome, Italy, 168|Rome, Lazio, Italy, 00128 A.O. San Camillo-ForlaniniRome, Lazio, Italy, 00152 Azienda Policlinico Universitario Umberto IRome, Lazio, Italy, 00161|Rozzano, Milano, Italy, 20089|Catania, Sicilia, Italy, 95126|Negrar, Verona, Italy, 37024|Nagakute, Aichi, Japan, 4801195 Nagoya University HospitalNagoya-Shi, Aichi, Japan, 466-8560 Nagoya City University HospitalNagoya-Shi, Aichi, Japan, 467-8602|Asahikawa-Shi, Japan, 078-8510 Hiroshima University HospitalHiroshima, Japan, 734-8551 The Hospital Of Hyogo CollegeNishinomiya-Shi, Japan, 663-8501 Kitasato University HospitalSagamihara-Shi, Japan, 252-0375 Kyoto University HospitalSakyo-Ku, Japan, 606-8507 Nho Shizuoka Medical CenterShimizu-Sho, Japan The Jikei University HospitalTokyo, Japan, 105-8461 Fujita Health University HospToyoake, Japan, 470-1192 Jp Red Cross Wakayama Med CtrWakayama, Japan Yokkaichi Hazu Medical CenterYokkaichi-Shi, Japan, 510-0016 Korea, Republic Of, Busan Gwang Yeogsi Dong-A University HospitalBusan, Busan Gwang Yeogsi, Korea, Republic Of, 49201 Pusan National University HospBusan, Busan Gwang Yeogsi, Korea, Republic Of, 602-739 Korea, Republic Of, Daegu Gwang Yeogsi Yeungnam University Med CtrDaegu, Daegu Gwang Yeogsi, Korea, Republic Of, 42415 Korea, Republic Of, Gyeonggido Cha Bundang Medical Center, Cha UniversitySeongnam-Si, Gyeonggido, Korea, Republic Of, 13496 St. Vincent'S HospitalSuwon, Gyeonggido, Korea, Republic Of, 16247 Korea, Republic Of, Seoul Teugbyeolsi Samsung Medical CenterGangnam-Gu, Seoul Teugbyeolsi, Korea, Republic Of, 06351 Kangbuk Samsung HospitalJongno-Gu, Seoul Teugbyeolsi, Korea, Republic Of, 03181 Severance HospitalSeoul, Seoul Teugbyeolsi, Korea, Republic Of, 03722 Korea, Republic Of Haeundae Paik HospitalBusan, Korea, Republic Of, 48108 Hanyang University Guri HospGuri-Si, Korea, Republic Of, 471-701|Sakura-Shi, Chiba, Japan, 285-8741|Kurume-Shi, Fukuoka, Japan, 830-0011|Takasaki-Shi, Gunma, Japan, 370-0829|Fukuyama-Shi, Hiroshima, Japan, 720-8520|Sapporo-Shi, Hokkaido, Japan, 060-8543 Hokkaido Sapporo-Kosei Gen HosSapporo, Hokkaido, Japan, 060-0033|Kobe, Hyogo, Japan, 650-0015|Kanazawa, Ishikawa, Japan, 92086-41|Sendai-Shi, Miyagi, Japan, 980-8574 Tohoku Rosai HospitalSendai-Shi, Miyagi, Japan, 981-8563|Saitama-Shi, Saitama, Japan, 336-0963|Otsu, Shiga, Japan, 520-2192|Bunkyo-Ku, Tokyo, Japan, 113-8519 Kitasato Univ Kitasato Inst HoMinato-Ku, Tokyo, Japan, 108-8642 Kyorin University HospitalMitaka-Shi, Tokyo, Japan, 181-8611|Yamagata-Shi, Yamagata, Japan, 990-9585|Riga, Latvia, 1038 P. Stradins Clinical Univ HospRiga, Latvia, Lv-1002 Veselibas Centrs 4 LtdRiga, Latvia, Lv-1012|Kovno, Kaunas, Lithuania, 50161|Klaipeda, Lithuania, Lt-92288 Vilnius University HospitalVilnius, Lithuania, Lt-08661|Tilburg, Netherlands, 5022 Gc|Amsterdam, Noord-Holland, Netherlands, 1105 Az|Bydgoszcz, Kujawsko-Pomorskie, Poland, 85-168|Lodz, Lodzkie, Poland, 90-302|Swidnik, Lubelskie, Poland, 21-040|Krakow, Malopolskie, Poland, 30-363|Warszawa, Mazowieckie, Poland, 01-783 Centralny Szpital Kliniczny Mswia W WarszawieWarszawa, Mazowieckie, Poland, 02-507 Centrum Onkologii-Instytut Im.M.Sklodowskiej-Curie W WarszawieWarszawa, Mazowieckie, Poland, 02-781|Sopot, Zachodniopomorskie, Poland, 81-756|Coimbra, Portugal, 3000-075 Hsog - Hospital Senhora Da OliGuimaraes, Portugal, 4835-044 Centro Hospitalar De Sao Joao, EpePorto, Portugal, 4200-319 Centro Hospitalar De Entre O DSanta Maria Da Feira, Portugal, 4520-211 Centro Hosp De Tondela-ViseuViseu, Portugal, 3504 - 509|Portimao, Faro, Portugal, 8500-338|Almada, Lisboa, Portugal, 2805-267 Centro Hosp De Lisboa CentralLisbon, Lisboa, Portugal, 1169-050|Bucharest, Romania, 22328 Spitalul Clinic Judetean MuresTargu Mures, Romania, 540103 Cabinet Particular Algomed SrlTimisoara, Romania, 300002 Centrul Medical Tuculanu SrlTimisoara, Romania, 300168|Nis, Nisavski Okrug, Serbia, 18000|Kragujevac, Sumadijski Okrug, Serbia, 34000|Novi Sad, Vojvodina, Serbia, 21000|Banska Bystrica, Slovakia, 97517 Gastro I.S.R.O.Presov, Slovakia, 08001|Martin, Zilinsky Kraj, Slovakia, 036 01|Johannesburg, Gauteng, South Africa, 2193|Cape Town, Western Cape, South Africa, 7700 Mediclinic ConstantiabergCape Town, Western Cape, South Africa, 7800|Cape Town, South Africa, 7708 Clinical Research UnitPretoria, South Africa, 0001|Barcelona, Spain, 08028 Hospital Clinic De BarcelonaBarcelona, Spain, 08036 Hospital Universitario Reina SCordoba, Spain, 14004 Hospital Universitario De CabuGijon, Spain, 33394 Hospital General Universitario Gregorio MaranonMadrid, 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Rooseve|Zilinsky Kraj Univerzitna Nemocnica Martin|, Gauteng Wits Clinical Research Site|, Western Cape Allergy & Immunology (Aiu)|Dr Jp Wright|Hospital Universitario Parc Tauli|Medicinmottagningen Sah Univ|Vastra Gotalands Lan AlingsÃ¥s Lasarett|Ankara Univ Medical Faculty|Kayseri Erciyes University Medical Fac|Kharkiv City Clinical Hospital|Kyivska Oblast Medical Centre Of \"Ukrainian German Antiulcer Gastroenterology Centre Byk-Kyiv\"|Vinnytska Oblast Vinnytsia Pirogov Reg Clin Hos|Barnsley Hospital Nhs Foundati|Southern California Res. Ctr.|Peak Gastroenterology Associat|Connecticut Gi|South Lake Pain Institute, Inc|Emory University Hospital|Northwestern University|Univ Kansas Med Ctr|Gastroenterology Assoc. La|Mgh Digestive Health Center|Center For Digestive Health|Mayo Clinic|Quality Clinical Research Inc.|Pediatric Gastro & Nutr Assoc|Columbia Univ Medical Center|Unc Health Care|Plains Clinical Research Center, Llc|The Ohio State University|Digestive Disease Specialists|University Of Pennsylvania|Gastro One|Inquest Clinical Research|Val R. Hansen|Digestive And Liver Disease Sp|Virginia Mason Medical Center",{"$nulls":3},"AbbVie Inc.","2018-04-27","2020-05-25T16:36:29.625","2020-05-26T17:10:42.972","NCT03398135"]
["5ecbf40d307e3d1b1f8d9cc8","NCT03398135","2018-07-16","AbbVie","ABBV","Not yet recruiting","A Study to Assess the Efficacy and Safety of Risankizumab in Subjects With Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065","Risankizumab","IL23 Inhibitor","Yes","['Risankizumab']","No",null,"Phase 3",6,760,"Anticipated","2018-08-21","2022-12-04",{"$nulls":5},"The purpose of this study is to evaluate safety and efficacy of risankizumab in subjects with ulcerative colitis (UC) in subjects who responded to induction treatment with rizankizumab in a prior AbbVie study of risankizumab in UC.\n\nThis study consists of three sub-studies: Substudy 1 is a 52-week, randomized, double-blind, placebo-controlled maintenance study; Substudy 2 is 52-week, randomized, exploratory maintenance study; and Substudy 3 is an open-label long-term extension study for subjects who completed Substudy 1 or 2.",null,"A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects With Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065","M16-066","Ulcerative Colitis (UC)","Colitis|Colitis, Ulcerative","Gastrointestinal Diseases","Gastrointestinal","Experimental|Placebo Comparator","Substudy 2: Open-label Risankizumab Dose 1|Substudy 1: Double-blind Risankizumab Dose 2|Substudy 2: Open-label Risankizumab Dose 2|Substudy 3: Open-label Extension Risankizumab|Substudy 1: Double-blind Placebo|Substudy 1: Double-blind Risankizumab Dose 1","Participants randomized to receive risankizumab dose 1 administered by subcutaneous (SC) injection.|Participants randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection.|Participants who completed Sub-study 1 or 2 receive open-label risankizumab in Sub-study 3.|Participants randomized to receive placebo for risankizumab administered by subcutaneous (SC) injection.","Drug","risankizumab|placebo for risankizumab","subcutaneous (SC) injection","ABBV-066 | BI 655066","Substudy 2: Open-label Risankizumab Dose 1|Substudy 1: Double-blind Risankizumab Dose 2|Substudy 2: Open-label Risankizumab Dose 2|Substudy 3: Open-label Extension Risankizumab|Substudy 1: Double-blind Placebo|Substudy 1: Double-blind Risankizumab Dose 1","\n\n * Subjects who have completed Study M16-065 or Study M16-067 and have achieved clinical response\n\n","\n\n * Subjects who have a known hypersensitivity to risankizumab or the excipients of any of the study drugs or the ingredients of chinese hamster ovary (CHO) or had an adverse event (AE) during Studies M16-065 or M16-067 that in the Investigator's judgment makes the subject unsuitable for this study\n * Subject is considered by the Investigator, for any reason, to be an unsuitable candidate for the study\n * Subject is not in compliance with prior and concomitant medication requirements throughout Studies M16-065 and M16-067",{"$nulls":4},"Actual","2018-01-12","Actual","Anticipated","2023-06-20","Anticipated","2018-07-01","2018-01-08","2018-01-08","2018-07-12","Yes","ABBV-066\nBI 655066","Interventional","Treatment","Parallel Assignment","Triple (Participant, Investigator, Outcomes Assessor)","Randomized","16 Years","80 Years","All",null,"No","Yes\nAbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2016-004676-22","EudraCT Number","Percentage of participants with clinical remission per adapted Mayo Score at Week 52","Clinical remission per Adapted Mayo Score.","Week 52","Percentage of participants with clinical remission per adapted Mayo Score at Week 52 in subjects with a clinical remission at Week 0|Percentage of participants who discontinued corticosteroid use at Week 52 in subjects who were taking steroids at Baseline (of induction)|Percentage of participants who discontinued corticosteroid use, remained corticosteroid free for 90 days, and achieved clinical remission per adapted Mayo Score at Week 52 in subjects taking steroids at Baseline (of induction).|Percentage of participants with endoscopic remission at Week 52|Ulcerative Colitis Symptom Questionnaire (UC-SQ): Change from Week 0 to Week 52|Percentage of participants with Ulcerative Colitis (UC)-related surgeries through Week 52|Percentage of participants with hospitalization through Week 52|36-Item Short Form Health Status Survey (SF-36): Change from Week 0 to Week 52|Inflammatory Bowel Disease Questionnaire (IBDQ): Change from Week 0 to Week 52|Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue): Change from Week 0 to Week 52|Percentage of participants with endoscopic improvement at Week 52|Percentage of participants with clinical remission per full Mayo Score at Week 52 in subjects with a full Mayo Score of 6 to 12 at Baseline (of Induction)|Percentage of participants with endoscopic improvement at Week 52 in participants with endoscopic improvement at Week 0|Percentage of participants with clinical response per adapted Mayo score at Week 52|Percentage of participants with histologic remission at Week 52|Percentage of participants with mucosal healing at Week 52","Clinical remission per Adapted Mayo Score.|Participants who discontinued corticosteroid use.|Endoscopic remission per endoscopy subscore.|The UC-SQ is a patient questionnaire to assess severity of ulcerative colitis symptoms.|Participants who underwent surgery related to UC.|Participants with an event that results in admission to the hospital.|The SF-36 is an indicator of overall health status.|The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.|The FACIT-Fatigue is a validated tool that measures an individual's level of fatigue during their usual daily activities over the past week.|Endoscopic improvement per endoscopy subscore.|Clinical remission per full Mayo Score.|Clinical response per Adapted Mayo score.|Histologic remission per Geboes Score.|Mucosal healing defined as endoscopic and histologic remission.","Week 52|Week 0, Week 52|52 weeks","abbvieclinicaltrials@abbvie.com","ABBVIE CALL CENTER","847.283.8955",{"$cut":{"chars":19703,"head":"Buenos Aires, Argentina, 1431 Hosp Privado Ctr Med Cordoba /Id# 167802Cordoba, Argentina, 5016 Sanatorio Guemes /Id# 170584Cuidad Autonoma De Buenosaires, Argentina, C1180Aad Instituto Medico Cer /Id# 168685Quilmes, Argentina, 1878 Sanatorio 9 De Julio S.A. /Id# 167803San Miguel De Tucuman, Argentina, 4000 Hopital Centenario /Id# 170896Santa Fe, Argentina, 2000|South Brisbane, Queensland, Australia, 4101|Graz, Austria, 8036 Lkh Salzburg And Paracelsus /Id# 200686Salzburg, Austria, 5020|St. PÃ¶lten, Niederoesterreich, Austria, 3100|Vienna, Wien, Austria, 1090|Brussels, Bruxelles-Capitale, Belgium, 1070 Cliniques Universitaires Saint Luc /Id# 200260Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200|Liege, Liege, Belgium, 4000|Gent, Oost-Vlaanderen, Belgium, 9000|Jette, Brussels, Belgium, 1090 Uz Leuven /Id# 170829Leuven, Belgium, 3000 Clinique St Joseph /Id# 200255Liege, Belgium, 4000 Az-Delta /Id# 200258Roeselare, Belgium, 8800 Chu Dinant Godinne - 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Per L'Emergenza Cannizzaro /Id# 164039|Verona Ospedale Classificato Equiparato Sacro Cuore-Don Calabria /Id# 164029|Aichi Aichi Medical University Hosp /Id# 164227|Chiba Toho University Sakura Med Ctr /Id# 164219|Fukuoka Kurume University Hospital /Id# 164237|Gunma National Hospital Organization Takasaki General Medical Center /Id# 164312|Hiroshima Nho Fukuyama Medical Center /Id# 164315|Hiroshima University Hospital /Id# 164240|Hokkaido Asahikawa Medical University Hospital /Id# 164324|Hyogo Aoyama Clinic /Id# 164236|Ishikawa Kanazawa University Ho /Id# 169221|Kanagawa Ofuna Chuo Hospital /Id# 169296|Mie Mie University Hospital /Id# 203635|Miyagi Tohoku University Hospital /Id# 164276|Nagasaki Nagasaki University Hospital /Id# 205326|Saitama Tokito Clinic /Id# 164218|Shiga Shiga Univ Med Science Hosp /Id# 164323|Tokyo Medical Hospital Of Tokyo Medical And Dental University /Id# 164225|Yamagata Yamagata University Hospital /Id# 171481|Riga East Clinical Univ Hosp /Id# 160204|Kaunas Hospital Of Lithuanian Univers /Id# 201142|Klaipeda Seamens Hospital /Id# 201143|/Id# 200633|Selangor Ukm Medical Centre /Id# 200634|Jalisco Ibiomed Guadalajara /Id# 206514|Jm Research /Id# 206518|Elisabeth Tweesteden Ziekenhui /Id# 163738|Noord-Holland Academisch Medisch Centrum /Id# 157965|, Canterbury Christchurch Hospital /Id# 205337|Wellington Hospital /Id# 205338|Kujawsko-Pomorskie Szpital Uniwersytecki Nr 2 Im. Dr J.Biziela W Bydgoszczy /Id# 170280|Lodzkie Nzoz Centrum Medyczne-Szpital Sw.Rodziny Sp.Zo.O. /Id# 170288|Lubelskie Lubelskie Centrum Diagnostyczne /Id# 170287|Malopolskie Centrum Medyczne Plejady /Id# 170635|Mazowieckie Centrum Zdrowia Mdm /Id# 170283|Zachodniopomorskie Endoskopia Sp. Z O.O. /Id# 170284|Chuc- Centro Hospitalar E Univ /Id# 166050|Faro Centro Hospitalar Do Algarve - Hospital De PortimÃ£o /Id# 166563|Lisboa Hospital Garcia De Orta, E.P.E /Id# 165579|Institutul Clinic Fundeni /Id# 171258|Southern California Res. Ctr. /Id# 169659|/Id# 200153|Sumadijski Okrug Clinical Center Kragujevac /Id# 156879|Fn S Poliklinikou F.D. Rooseve /Id# 164348|, Gauteng Wits Clinical Research Site /Id# 171140|, Western Cape Allergy & Immunology (Aiu) /Id# 171439|Dr Jp Wright /Id# 171142|Hospital Universitario Parc Tauli /Id# 159473|Medicinmottagningen Sah Univ /Id# 202841|Vastra Gotalands Lan AlingsÃ¥s Lasarett /Id# 202075|Ankara Univ Medical Faculty /Id# 167205|Kayseri Erciyes University Medical Fac /Id# 171283|Kharkiv City Clinical Hospital /Id# 166211|Kyivska Oblast Medical Centre Of \"Ukrainian German Antiulcer Gastroenterology Centre Byk-Kyiv\" /Id# 203740|Vinnytska Oblast Vinnytsia Pirogov Reg Clin Hos /Id# 204371|Barnsley Hospital Nhs Foundati /Id# 202771|Ucsd /Id# 160430|Peak Gastroenterology Associat /Id# 165838|Connecticut Gi /Id# 164712|South Lake Pain Institute, Inc /Id# 162859|Emory University Hospital /Id# 160570|University Of Chicago /Id# 160511|Indiana University /Id# 167250|Univ Kansas Med Ctr /Id# 161865|Houma Digestive Health Special /Id# 158377|Mgh Digestive Health Center /Id# 164257|Center For Digestive Health /Id# 160300|Mayo Clinic - Rochester /Id# 200455|Quality Clinical Research Inc. /Id# 167312|North Shore University Hospital /Id# 168743|Charlotte Gastro Hepatology /Id# 158543|Plains Clinical Research Center, Llc /Id# 169729|The Ohio State University - Columbus /Id# 164713|Digestive Disease Specialists /Id# 170777|University Of Pennsylvania /Id# 166262|Greenville Endoscopy Center /Id# 160457|Gastro One /Id# 160373|Inquest Clinical Research /Id# 165686|Val R. Hansen /Id# 163004|Virginia Mason Medical Center /Id# 160432",{"$nulls":3},"AbbVie Inc.","2018-07-12","2020-05-25T16:36:29.578","2020-05-26T17:10:42.972","NCT03398135"]
["5ecbf40de2561b1b11905d33","NCT03398135","2018-09-10","AbbVie","ABBV","Enrolling by invitation","A Study to Assess the Efficacy and Safety of Risankizumab in Subjects With Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065","Risankizumab","IL23 Inhibitor","Yes","['Risankizumab']","No",null,"Phase 3",6,760,"Anticipated","2018-08-28","2022-12-04",{"$nulls":5},"The purpose of this study is to evaluate safety and efficacy of risankizumab in subjects with ulcerative colitis (UC) in subjects who responded to induction treatment with rizankizumab in a prior AbbVie study of risankizumab in UC.\n\nThis study consists of three sub-studies: Substudy 1 is a 52-week, randomized, double-blind, placebo-controlled maintenance study; Substudy 2 is 52-week, randomized, exploratory maintenance study; and Substudy 3 is an open-label long-term extension study for subjects who completed Substudy 1 or 2.",null,"A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects With Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065","M16-066","Ulcerative Colitis (UC)","Colitis|Colitis, Ulcerative","Gastrointestinal Diseases","Gastrointestinal","Experimental|Placebo Comparator","Substudy 2: Open-label Risankizumab Dose 1|Substudy 1: Double-blind Risankizumab Dose 2|Substudy 2: Open-label Risankizumab Dose 2|Substudy 3: Open-label Extension Risankizumab|Substudy 1: Double-blind Placebo|Substudy 1: Double-blind Risankizumab Dose 1","Participants randomized to receive risankizumab dose 1 administered by subcutaneous (SC) injection.|Participants randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection.|Participants who completed Sub-study 1 or 2 receive open-label risankizumab in Sub-study 3.|Participants randomized to receive placebo for risankizumab administered by subcutaneous (SC) injection.","Drug","risankizumab|placebo for risankizumab","subcutaneous (SC) injection","ABBV-066 | BI 655066","Substudy 2: Open-label Risankizumab Dose 1|Substudy 1: Double-blind Risankizumab Dose 2|Substudy 2: Open-label Risankizumab Dose 2|Substudy 3: Open-label Extension Risankizumab|Substudy 1: Double-blind Placebo|Substudy 1: Double-blind Risankizumab Dose 1","\n\n * Subjects who have completed Study M16-065 or Study M16-067 and have achieved clinical response\n\n","\n\n * Subjects who have a known hypersensitivity to risankizumab or the excipients of any of the study drugs or the ingredients of chinese hamster ovary (CHO) or had an adverse event (AE) during Studies M16-065 or M16-067 that in the Investigator's judgment makes the subject unsuitable for this study\n * Subject is considered by the Investigator, for any reason, to be an unsuitable candidate for the study\n * Subject is not in compliance with prior and concomitant medication requirements throughout Studies M16-065 and M16-067",{"$nulls":4},"Actual","2018-01-12","Actual","Anticipated","2023-06-20","Anticipated","2018-09-01","2018-01-08","2018-01-08","2018-09-07","Yes","ABBV-066\nBI 655066","Interventional","Treatment","Parallel Assignment","Triple (Participant, Investigator, Outcomes Assessor)","Randomized","16 Years","80 Years","All",null,"No","Yes\nAbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2016-004676-22","EudraCT Number","Percentage of participants with clinical remission per adapted Mayo Score at Week 52","Clinical remission per Adapted Mayo Score.","Week 52","Percentage of participants with clinical remission per adapted Mayo Score at Week 52 in subjects with a clinical remission at Week 0|Percentage of participants who discontinued corticosteroid use at Week 52 in subjects who were taking steroids at Baseline (of induction)|Percentage of participants who discontinued corticosteroid use, remained corticosteroid free for 90 days, and achieved clinical remission per adapted Mayo Score at Week 52 in subjects taking steroids at Baseline (of induction).|Percentage of participants with endoscopic remission at Week 52|Ulcerative Colitis Symptom Questionnaire (UC-SQ): Change from Week 0 to Week 52|Percentage of participants with Ulcerative Colitis (UC)-related surgeries through Week 52|Percentage of participants with hospitalization through Week 52|36-Item Short Form Health Status Survey (SF-36): Change from Week 0 to Week 52|Inflammatory Bowel Disease Questionnaire (IBDQ): Change from Week 0 to Week 52|Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue): Change from Week 0 to Week 52|Percentage of participants with endoscopic improvement at Week 52|Percentage of participants with clinical remission per full Mayo Score at Week 52 in subjects with a full Mayo Score of 6 to 12 at Baseline (of Induction)|Percentage of participants with endoscopic improvement at Week 52 in participants with endoscopic improvement at Week 0|Percentage of participants with clinical response per adapted Mayo score at Week 52|Percentage of participants with histologic remission at Week 52|Percentage of participants with mucosal healing at Week 52","Clinical remission per Adapted Mayo Score.|Participants who discontinued corticosteroid use.|Endoscopic remission per endoscopy subscore.|The UC-SQ is a patient questionnaire to assess severity of ulcerative colitis symptoms.|Participants who underwent surgery related to UC.|Participants with an event that results in admission to the hospital.|The SF-36 is an indicator of overall health status.|The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.|The FACIT-Fatigue is a validated tool that measures an individual's level of fatigue during their usual daily activities over the past week.|Endoscopic improvement per endoscopy subscore.|Clinical remission per full Mayo Score.|Clinical response per Adapted Mayo score.|Histologic remission per Geboes Score.|Mucosal healing defined as endoscopic and histologic remission.","Week 52|Week 0, Week 52|52 weeks",{"$nulls":3},{"$cut":{"chars":20071,"head":"Buenos Aires, Argentina, 1431 Hosp Privado Ctr Med Cordoba /Id# 167802Cordoba, Argentina, 5016 Sanatorio Guemes /Id# 170584Cuidad Autonoma De Buenosaires, Argentina, C1180Aad Instituto Medico Cer /Id# 168685Quilmes, Argentina, 1878 Sanatorio 9 De Julio S.A. /Id# 167803San Miguel De Tucuman, Argentina, 4000 Hopital Centenario /Id# 170896Santa Fe, Argentina, 2000|South Brisbane, Queensland, Australia, 4101|Graz, Austria, 8036 Lkh Salzburg And Paracelsus /Id# 200686Salzburg, Austria, 5020|St. PÃ¶lten, Niederoesterreich, Austria, 3100|Vienna, Wien, Austria, 1090|Brussels, Bruxelles-Capitale, Belgium, 1070 Cliniques Universitaires Saint Luc /Id# 200260Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200|Liege, Liege, Belgium, 4000|Gent, Oost-Vlaanderen, Belgium, 9000|Jette, Brussels, Belgium, 1090 Uz Leuven /Id# 170829Leuven, Belgium, 3000 Clinique St Joseph /Id# 200255Liege, Belgium, 4000 Az-Delta /Id# 200258Roeselare, Belgium, 8800 Chu Dinant Godinne - Ucl Namur /Id# 200259Yvoir, Belgium, 5530|Goiania, Goias, Brazil, 74535-170|Sofia, Bulgaria, 1202 Umhat Sv. Ivan Rilski /Id# 206523Sofia, Bulgaria, 1612 Mbal Trakia /Id# 201811Stara Zagora, Bulgaria, 6004|Calgary, Alberta, Canada, T2N 4Z6 Allen Whey Khye Lim Professional Corporation /Id# 169770Edmonton, Alberta, Canada, T5R 1W2 Zeidler Ledcor Centre /Id# 204589Edmonton, Alberta, Canada, T6G 2X8 South Edmonton Gastroenterolog /Id# 169128Edmonton, Alberta, Canada, T6L 6K3|New Westminster, British Columbia, Canada, V3L 3W4 Percuro Clinical Research, Ltd /Id# 169123Victoria, British Columbia, Canada, V8V 3M9|Halifax, New Brunswick, Canada, B3H 2Y9|London, Ontario, Canada, N6A 5A5 Scott Shulman Medicine Professional Corporation /Id# 169127North Bay, Ontario, Canada, P1B 2H3 Toronto Digestive Diseases Ass /Id# 169120Vaughan, Ontario, Canada, L4L 4Y7|Greenfield Park, Quebec, Canada, J4V 2H1 Ciusss De L'Est-De-L'Ile-De-Mo /Id# 169122MontrÃ©al, Quebec, Canada, H1T 2M4 Montreal General Hospital /Id# 169118MontrÃ©al, Quebec, Canada, H3G 1A4|Talcahuano, Chile|Santiago, Region Metropolitana De Santiago, Chile, 8207257 Hospital San Juan De Dios /Id# 171124Santiago, Region Metropolitana De Santiago, Chile, 8350488 Hospital Clinico Universidad /Id# 170050Santiago, Region Metropolitana De Santiago, Chile, 8380456|ViÃ±a Del Mar, ValparaÃ­so, Chile, 2540488|Medellin, Colombia, 050024 Hospital Universitario San Vic /Id# 171488Medellin, Colombia, 50010 Inst Med Alta Tec Onc (Imat) /Id# 207041MonterÃ­a, Colombia, 230002|Zagreb, Grad Zagreb, Croatia, 10000 Klinicki Bolnicki Centar Zagreb /Id# 157594Zagreb, Grad Zagreb, Croatia, 10000 Klinicki Bolnicki Centar Zagreb /Id# 201915Zagreb, Grad Zagreb, Croatia, 10000|Split, Croatia, 21000|Osijek, Osjecko-Baranjska Zupanija, Croatia, 31000|Hvidovre, Denmark, 2650|Aalborg, Nordjylland, Denmark, 9000|Roskilde, SjÃ¦lland, Denmark, 4000|Nyborg, Syddanmark, Denmark, 5800|Alexandria, Egypt, 21131 Nat Hep & Trop Med Res Inst /Id# 201825Cairo, Egypt, 1141 Air Force Specialized Hospital /Id# 170984Cairo, Egypt National Liver Institute /Id# 171042Menoufiya, Egypt, 35111|Mannheim, Baden-Wuerttemberg, Germany, 68167|Erlangen, Bayern, Germany, 91054|Berlin, Germany, 10117 Gastroenterologie Am Bayerisch /Id# 159380Berlin, Germany, 10825 Drk Kliniken Berlin /Id# 166155Berlin, Germany, 14050 Stadtisches Klinikum Braunschw /Id# 163694Braunschweig, Germany, 38126 Agaplesion Markus Krankenhaus /Id# 159375Frankfurt, Germany, 60341 UniversitÃ¤tsklinikum Freiburg /Id# 162038Freiburg, Germany, 79106 Asklepios Westklinikum Hamburg /Id# 159377Hamburg, Germany, 22559 Med Hochschule Hanover /Id# 162040Hannover, Germany, 30625 Praxis Fuer Gastroenterologie /Id# 166154Heidelberg, Germany, 69121 Gastroenterologie Opernstrasse /Id# 163690Kassel, Germany, 34117 Klinikum Lueneburg /Id# 163692Lueneburg, Germany, 21339 Gastro Gemeinschaftspraxis /Id# 162037Minden, Germany, 32423 Klinikum Univ Regensburg /Id# 163693Regensburg, Germany, 93042 Universitatsklinikum Tubingen /Id# 159382Tuebingen, Germany, 72076|KÃ¶ln, Nordrhein-Westfalen, Germany, 50937|Kiel, Schleswig-Holstein, Germany, 241"}},"Arizona|California|Colorado|Connecticut|Florida|Georgia|Illinois|Indiana|Kansas|Louisiana|Massachusetts|Michigan|Minnesota|Nebraska|New York|North Carolina|North Dakota|Ohio|Oklahoma|Pennsylvania|South Carolina|Tennessee|Texas|Utah|Washington","Argentina|Australia|Austria|Belgium|Brazil|Bulgaria|Canada|Chile|Colombia|Croatia|Denmark|Egypt|Germany|Greece|Hungary|Israel|Italy|Japan|Latvia|Lithuania|Malaysia|Mexico|Netherlands|New Zealand|Poland|Portugal|Romania|Samoa|Serbia|Singapore|Slovakia|South Africa|Spain|Sweden|Switzerland|Turkey|Ukraine|United Kingdom|United States","Cemic /Id# 167805|Queensland Mater Misericordiae /Id# 205330|Lkh-Univ. Klinikum Graz /Id# 169052|Niederoesterreich UniversitÃ¤tsklinikum St.PÃ¶lten /Id# 169049|Wien Medical University Of Vienna /Id# 169051|Bruxelles-Capitale Cub Hospital Erasme /Id# 200256|Liege Chu De Liege /Id# 200257|Oost-Vlaanderen Uz Gent /Id# 200261|Uz Brussels /Id# 164175|Goias Instituto Goiano De Gastroenterologia /Id# 157683|Ii Mhat - Sofia /Id# 200794|Alberta University Of Calgary /Id# 169125|British Columbia Fraser Clinical Trials Inc /Id# 169116|New Brunswick Qeii Health Sciences Centre /Id# 169121|Ontario London Health Sciences Centre /Id# 169117|Quebec Hopital Charles-Lemoyne /Id# 169119|Hospital Las Higueras /Id# 167094|Region Metropolitana De Santiago Complejo Asistencial Dr. Sotero Del Rio /Id# 169386|ValparaÃ­so Centro De Investigaciones ClÃ­nicas ViÃ±a Del Mar /Id# 203606|Instituto De Coloproctologia /Id# 158742|Grad Zagreb Klinicka Bolnica Dubrava Zagreb /Id# 157598|Klinicki Bolnicki Centar Split /Id# 157596|Osjecko-Baranjska Zupanija Klinicki Bolnicki Centar Osijek /Id# 157595|Hvidovre Hospital /Id# 205093|Nordjylland Aarhus University Hospital /Id# 200072|SjÃ¦lland Sjaellands Universitets Hospit /Id# 200073|Syddanmark Svendborg Sygehus, Sygehusenhe /Id# 200071|University Of Alexandria /Id# 201824|Baden-Wuerttemberg Universitatsklinikum Mannheim /Id# 162039|Bayern Universitaetsklinikum Erlangen /Id# 159373|CharitÃ© UniversitÃ¤tsmedizin Campus Mitte /Id# 163695|Nordrhein-Westfalen Uniklinik Koln /Id# 164993|Schleswig-Holstein Univ Hosp Schleswig-Holstein /Id# 159379|Thueringen Universitaetsklinikum Ulm /Id# 164994|Attiki Tzaneio General Hospital Of Piraeus /Id# 206437|Gen Hosp Chest Athens Sotiria /Id# 170910|Kriti University Hospital Of Heraklion /Id# 165327|Baranya Mohacsi Korhaz /Id# 205285|Borsod-Abauj-Zemplen Miskolci Semmelweis Korhaz Es /Id# 201281|Heves Bugat Pal Korhaz /Id# 202526|Mh Egeszsegugyi Kozpont /Id# 157338|Pest Obudai Egeszsegugyi Kozpont /Id# 201921|Rambam Medical Center /Id# 171096|Tel-Aviv Rabin Medical Center /Id# 167402|Yerushalayim Hadassah Ein Kerem Medical Ctr /Id# 171092|Calabria UniversitÃ  Di Catanzaro \"Magna Graecia\" /Id# 200124|Emilia-Romagna Ospedale Sant Orsola Malpighi /Id# 155627|Lazio Policlinico Universitario Campus Bio-Medico /Id# 163994|Milano Istituto Clinico Humanitas /Id# 155626|Ospedali Riuniti Universita /Id# 206809|Sicilia A.O. Per L'Emergenza Cannizzaro /Id# 164039|Verona Ospedale Classificato Equiparato Sacro Cuore-Don Calabria /Id# 164029|Aichi Aichi Medical University Hosp /Id# 164227|Chiba Toho University Sakura Med Ctr /Id# 164219|Fukuoka Kurume University Hospital /Id# 164237|Gunma National Hospital Organization Takasaki General Medical Center /Id# 164312|Hiroshima Nho Fukuyama Medical Center /Id# 164315|Hiroshima University Hospital /Id# 164240|Hokkaido Asahikawa Medical University Hospital /Id# 164324|Hyogo Aoyama Clinic /Id# 164236|Ishikawa Kanazawa University Ho /Id# 169221|Kanagawa Ofuna Chuo Hospital /Id# 169296|Mie Mie University Hospital /Id# 203635|Miyagi Tohoku University Hospital /Id# 164276|Nagasaki Nagasaki University Hospital /Id# 205326|Saitama Tokito Clinic /Id# 164218|Shiga Shiga Univ Med Science Hosp /Id# 164323|Tokyo Medical Hospital Of Tokyo Medical And Dental University /Id# 164225|Yamagata Yamagata University Hospital /Id# 171481|Riga East Clinical Univ Hosp /Id# 160204|Kaunas Hospital Of Lithuanian Univers /Id# 201142|Klaipeda Seamens Hospital /Id# 201143|/Id# 200633|Selangor Ukm Medical Centre /Id# 200634|Jalisco Ibiomed Guadalajara /Id# 206514|Jm Research /Id# 206518|Elisabeth Tweesteden Ziekenhui /Id# 163738|Noord-Holland Academisch Medisch Centrum /Id# 157965|, Canterbury Christchurch Hospital /Id# 205337|Wellington Hospital (Capital And Coast District Health Board) /Id# 205338|Kujawsko-Pomorskie Szpital Uniwersytecki Nr 2 Im. Dr J.Biziela W Bydgoszczy /Id# 170280|Lodzkie Nzoz Centrum Medyczne-Szpital Sw.Rodziny Sp.Zo.O. /Id# 170288|Malopolskie Centrum Medyczne Plejady /Id# 170635|Mazowieckie Centrum Zdrowia Mdm /Id# 170283|Zachodniopomorskie Endoskopia Sp. Z O.O. /Id# 170284|Chuc- Centro Hospitalar E Univ /Id# 166050|Faro Centro Hospitalar Do Algarve - Hospital De PortimÃ£o /Id# 166563|Lisboa Centro Hosp De Lisboa Central /Id# 165578|Setubal Hospital Garcia De Orta, E.P.E /Id# 165579|Institutul Clinic Fundeni /Id# 171258|Southern California Res. Ctr. /Id# 169659|/Id# 200153|Sumadijski Okrug Clinical Center Kragujevac /Id# 156879|Fn S Poliklinikou F.D. Rooseve /Id# 164348|, Gauteng Wits Clinical Research Site /Id# 171140|, Western Cape Allergy & Immunology (Aiu) /Id# 171439|Dr Jp Wright /Id# 171142|Hospital Universitario Parc Tauli /Id# 159473|Pontevedra Hospital Alvaro Cunqueiro /Id# 167359|Su Molndal. /Id# 202841|Vastra Gotalands Lan AlingsÃ¥s Lasarett /Id# 202075|Universitaetsspital Basel /Id# 206681|Ankara Univ Medical Faculty /Id# 167205|Kayseri Erciyes University Medical Fac /Id# 171283|Kharkiv City Clinical Hospital /Id# 166211|Kyivska Oblast Medical Centre Of \"Ukrainian German Antiulcer Gastroenterology Centre Byk-Kyiv\" /Id# 203740|Vinnytska Oblast Vinnytsia Pirogov Reg Clin Hos /Id# 204371|, Devon Rd&E Hospital /Id# 157614|Barnsley Hospital Nhs Foundati /Id# 202771|University Arizona Cancer Ctr /Id# 158387|Ucsd /Id# 160430|Peak Gastroenterology Associat /Id# 165838|Medical Research Ctr Ct /Id# 160287|South Lake Pain Institute, Inc /Id# 162859|Emory University Hospital /Id# 160570|University Of Chicago /Id# 160511|Indiana University /Id# 167250|Univ Kansas Med Ctr /Id# 161865|Delricht Research /Id# 206817|Mgh Digestive Health Center /Id# 164257|Center For Digestive Health /Id# 160300|Mayo Clinic - Rochester /Id# 200455|Quality Clinical Research Inc. /Id# 167312|Columbia Univ Medical Center /Id# 161929|Charlotte Gastro Hepatology /Id# 158543|Plains Clinical Research Center, Llc /Id# 169729|The Ohio State University - Columbus /Id# 164713|Digestive Disease Specialists /Id# 170777|University Of Pennsylvania /Id# 166262|Greenville Endoscopy Center /Id# 160457|Gastro One /Id# 160373|Inquest Clinical Research /Id# 165686|Val R. Hansen /Id# 163004|Virginia Mason Medical Center /Id# 160432",{"$nulls":3},"AbbVie Inc.","2018-09-07","2020-05-25T16:36:29.651","2020-05-26T17:10:42.972","NCT03398135"]
["5ecbf40efe30261b1a048238","NCT03398135","2018-09-28","AbbVie","ABBV","Recruiting","A Study to Assess the Efficacy and Safety of Risankizumab in Subjects With Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065","Risankizumab","IL23 Inhibitor","Yes","['Risankizumab']","No",null,"Phase 3",6,760,"Anticipated","2018-08-28","2022-12-04",{"$nulls":5},"The purpose of this study is to evaluate safety and efficacy of risankizumab in subjects with ulcerative colitis (UC) in subjects who responded to induction treatment with risankizumab in a prior AbbVie study of risankizumab in UC.\n\nThis study consists of three sub-studies: Substudy 1 is a 52-week, randomized, double-blind, placebo-controlled maintenance study; Substudy 2 is 52-week, randomized, exploratory maintenance study; and Substudy 3 is an open-label long-term extension study for subjects who completed Substudy 1 or 2.",null,"A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects With Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065","M16-066","Ulcerative Colitis (UC)","Colitis|Colitis, Ulcerative","Gastrointestinal Diseases","Gastrointestinal","Experimental|Placebo Comparator","Substudy 2: Open-label Risankizumab Dose 1|Substudy 1: Double-blind Risankizumab Dose 2|Substudy 2: Open-label Risankizumab Dose 2|Substudy 3: Open-label Extension Risankizumab|Substudy 1: Double-blind Placebo|Substudy 1: Double-blind Risankizumab Dose 1","Participants randomized to receive risankizumab dose 1 administered by subcutaneous (SC) injection.|Participants randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection.|Participants who completed Sub-study 1 or 2 receive open-label risankizumab in Sub-study 3.|Participants randomized to receive placebo for risankizumab administered by subcutaneous (SC) injection.","Drug","risankizumab|placebo for risankizumab","subcutaneous (SC) injection","ABBV-066 | BI 655066","Substudy 2: Open-label Risankizumab Dose 1|Substudy 1: Double-blind Risankizumab Dose 2|Substudy 2: Open-label Risankizumab Dose 2|Substudy 3: Open-label Extension Risankizumab|Substudy 1: Double-blind Placebo|Substudy 1: Double-blind Risankizumab Dose 1","\n\n- Subjects who have completed Study M16-065 or Study M16-067 and have achieved clinical response\n\n","\n\n * Subjects who have a known hypersensitivity to risankizumab or the excipients of any of the study drugs or the ingredients of chinese hamster ovary (CHO) or had an adverse event (AE) during Studies M16-065 or M16-067 that in the Investigator's judgment makes the subject unsuitable for this study\n * Subject is considered by the Investigator, for any reason, to be an unsuitable candidate for the study\n * Subject is not in compliance with prior and concomitant medication requirements throughout Studies M16-065 and M16-067",{"$nulls":4},"Actual","2018-01-12","Actual","Anticipated","2023-06-20","Anticipated","2018-09-01","2018-01-08","2018-01-08","2018-09-26","Yes","ABBV-066\nBI 655066","Interventional","Treatment","Parallel Assignment","Triple (Participant, Investigator, Outcomes Assessor)","Randomized","16 Years","80 Years","All",null,"No","Yes\nAbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2016-004676-22","EudraCT Number","Percentage of participants with clinical remission per adapted Mayo Score at Week 52","Clinical remission per Adapted Mayo Score.","Week 52","Percentage of participants with clinical remission per adapted Mayo Score at Week 52 in subjects with a clinical remission at Week 0|Percentage of participants who discontinued corticosteroid use at Week 52 in subjects who were taking steroids at Baseline (of induction)|Percentage of participants who discontinued corticosteroid use, remained corticosteroid free for 90 days, and achieved clinical remission per adapted Mayo Score at Week 52 in subjects taking steroids at Baseline (of induction).|Percentage of participants with endoscopic remission at Week 52|Ulcerative Colitis Symptom Questionnaire (UC-SQ): Change from Week 0 to Week 52|Percentage of participants with Ulcerative Colitis (UC)-related surgeries through Week 52|Percentage of participants with hospitalization through Week 52|36-Item Short Form Health Status Survey (SF-36): Change from Week 0 to Week 52|Inflammatory Bowel Disease Questionnaire (IBDQ): Change from Week 0 to Week 52|Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue): Change from Week 0 to Week 52|Percentage of participants with endoscopic improvement at Week 52|Percentage of participants with clinical remission per full Mayo Score at Week 52 in subjects with a full Mayo Score of 6 to 12 at Baseline (of Induction)|Percentage of participants with endoscopic improvement at Week 52 in participants with endoscopic improvement at Week 0|Percentage of participants with clinical response per adapted Mayo score at Week 52|Percentage of participants with histologic remission at Week 52|Percentage of participants with mucosal healing at Week 52","Clinical remission per Adapted Mayo Score.|Participants who discontinued corticosteroid use.|Endoscopic remission per endoscopy subscore.|The UC-SQ is a patient questionnaire to assess severity of ulcerative colitis symptoms.|Participants who underwent surgery related to UC.|Participants with an event that results in admission to the hospital.|The SF-36 is an indicator of overall health status.|The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.|The FACIT-Fatigue is a validated tool that measures an individual's level of fatigue during their usual daily activities over the past week.|Endoscopic improvement per endoscopy subscore.|Clinical remission per full Mayo Score.|Clinical response per Adapted Mayo score.|Histologic remission per Geboes Score.|Mucosal healing defined as endoscopic and histologic remission.","Week 52|Week 0, Week 52|52 weeks","abbvieclinicaltrials@abbvie.com","ABBVIE CALL CENTER","847.283.8955",{"$cut":{"chars":20919,"head":"Buenos Aires, Argentina, 1431 Instituto Medico Cer /Id# 168685Quilmes, Argentina, 1878 Sanatorio 9 De Julio S.A. /Id# 167803San Miguel De Tucuman, Argentina, 4000 Hopital Centenario /Id# 170896Santa Fe, Argentina, 2000|South Brisbane, Queensland, Australia, 4101|Graz, Austria, 8036 Lkh Salzburg And Paracelsus /Id# 200686Salzburg, Austria, 5020|St. PÃ¶lten, Niederoesterreich, Austria, 3100|Vienna, Wien, Austria, 1090|Brussels, Bruxelles-Capitale, Belgium, 1070 Cliniques Universitaires Saint Luc /Id# 200260Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200|Liege, Liege, Belgium, 4000|Gent, Oost-Vlaanderen, Belgium, 9000|Jette, Brussels, Belgium, 1090 Uz Leuven /Id# 170829Leuven, Belgium, 3000 Clinique St Joseph /Id# 200255Liege, Belgium, 4000 Az-Delta /Id# 200258Roeselare, Belgium, 8800 Chu Dinant Godinne - Ucl Namur /Id# 200259Yvoir, Belgium, 5530|Goiania, Goias, Brazil, 74535-170|Curitiba, Parana, Brazil, 80810-040|Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903|Botucatu, Sao Paulo, Brazil, 18618-686 Hospital Das Clinicas Da Faculdade De Medicina De RibeirÃ£o Preto - Usp /Id# 157668RibeirÃ£o Preto, Sao Paulo, Brazil, 14048-900 Faculdade De Medicina Do Abc /Id# 163993Santo AndrÃ©, Sao Paulo, Brazil, 09060-870 Kaiser Clinica E Hospital Dia /Id# 157686Sao Jose Do Rio Preto, Sao Paulo, Brazil, 15015-110|Sofia, Bulgaria, 1202 Umhat Sv. Ivan Rilski /Id# 206523Sofia, Bulgaria, 1612 Mbal Trakia /Id# 201811Stara Zagora, Bulgaria, 6004|Calgary, Alberta, Canada, T2N 4Z6 Allen Whey Khye Lim Professional Corporation /Id# 169770Edmonton, Alberta, Canada, T5R 1W2 Zeidler Ledcor Centre /Id# 204589Edmonton, Alberta, Canada, T6G 2X8 Covenant Health /Id# 169128Edmonton, Alberta, Canada, T6L 6K3|New Westminster, British Columbia, Canada, V3L 3W4 Percuro Clinical Research, Ltd /Id# 169123Victoria, British Columbia, Canada, V8V 3M9|Halifax, New Brunswick, Canada, B3H 2Y9|London, Ontario, Canada, N6A 5A5 Scott Shulman Medicine Professional Corporation /Id# 169127North Bay, Ontario, Canada, P1B 2H3 Toronto Digestive Diseases Ass /Id# 169120Vaughan, Ontario, Canada, L4L 4Y7|Greenfield Park, Quebec, Canada, J4V 2H1 Ciusss De L'Est-De-L'Ile-De-Mo /Id# 169122MontrÃ©al, Quebec, Canada, H1T 2M4 Montreal General Hospital /Id# 169118MontrÃ©al, Quebec, Canada, H3G 1A4|Talcahuano, Chile|Santiago, Region Metropolitana De Santiago, Chile, 8207257 Hospital San Juan De Dios /Id# 171124Santiago, Region Metropolitana De Santiago, Chile, 8350488 Hospital Clinico Universidad /Id# 170050Santiago, Region Metropolitana De Santiago, Chile, 8380456|ViÃ±a Del Mar, ValparaÃ­so, Chile, 2540488|Medellin, Colombia, 050024 Hospital Universitario San Vic /Id# 171488Medellin, Colombia, 50010 Inst Med Alta Tec Onc (Imat) /Id# 207041MonterÃ­a, Colombia, 230002|Zagreb, Grad Zagreb, Croatia, 10000 Klinicki Bolnicki Centar Zagreb /Id# 157594Zagreb, Grad Zagreb, Croatia, 10000 Klinicki Bolnicki Centar Zagreb /Id# 201915Zagreb, Grad Zagreb, Croatia, 10000|Split, Croatia, 21000|Osijek, Osjecko-Baranjska Zupanija, Croatia, 31000|Hvidovre, Denmark, 2650|Aarhus, Nordjylland, Denmark, 8000|Roskilde, SjÃ¦lland, Denmark, 4000|Nyborg, Syddanmark, Denmark, 5800|Alexandria, Egypt, 21131 Nat Hep & Trop Med Res Inst /Id# 201825Cairo, Egypt, 1141 Air Force Specialized Hospital /Id# 170984Cairo, Egypt National Liver Institute /Id# 171042Menoufiya, Egypt, 35111|Nice Cedex 3, Alpes-Maritimes, France, 06202|Amiens Cedex 1, France, 80054|Pessac Cedex, Gironde, France, 33604|Clichy, Ile-De-|St. Priest En Jarez, Loire, France, 42270|Mannheim, Baden-Wuerttemberg, Germany, 68167|Erlangen, Bayern, Germany, 91054|Berlin, Germany, 10117 Gastroenterologie Am Bayerisch /Id# 159380Berlin, Germany, 10825 Drk Kliniken Berlin /Id# 166155Berlin, Germany, 14050 Stadtisches Klinikum Braunschw /Id# 163694Braunschweig, Germany, 38126 Agaplesion Markus Krankenhaus /Id# 159375Frankfurt, Germany, 60341 UniversitÃ¤tsklinikum Freiburg /Id# 162038Freiburg, Germany, 79106 Asklepios Westklinikum Hamburg /Id# 159377Hamburg, Germany, 22559 Med Hochschule Hanover /Id# 162040Hannover, Germany, 30625 Praxis Fuer Gastroent"}},"Arizona|California|Colorado|Connecticut|Florida|Georgia|Illinois|Indiana|Kansas|Louisiana|Massachusetts|Michigan|Minnesota|Nebraska|New York|North Carolina|North Dakota|Ohio|Oklahoma|Pennsylvania|South Carolina|Tennessee|Texas|Utah|Washington","Argentina|Australia|Austria|Belgium|Brazil|Bulgaria|Canada|Chile|Colombia|Croatia|Denmark|Egypt|France|Germany|Greece|Hungary|Israel|Italy|Japan|Latvia|Lithuania|Malaysia|Mexico|Netherlands|New Zealand|Poland|Portugal|Romania|Samoa|Serbia|Singapore|Slovakia|South Africa|Spain|Sweden|Switzerland|Turkey|Ukraine|United Kingdom|United States","Cemic /Id# 167805|Queensland Mater Misericordiae /Id# 205330|Lkh-Univ. Klinikum Graz /Id# 169052|Niederoesterreich UniversitÃ¤tsklinikum St.PÃ¶lten /Id# 169049|Wien Medical University Of Vienna /Id# 169051|Bruxelles-Capitale Cub Hospital Erasme /Id# 200256|Liege Chu De Liege /Id# 200257|Oost-Vlaanderen Uz Gent /Id# 200261|Uz Brussels /Id# 164175|Goias Instituto Goiano De Gastroenterologia /Id# 157683|Parana Hospital Nossa Senhora Das GraÃ§as /Id# 157677|Rio Grande Do Sul Hospital De Clinicas De Porto Alegre /Id# 157670|Sao Paulo Upeclin Fmb - Unesp /Id# 157691|Ii Mhat - Sofia /Id# 200794|Alberta University Of Calgary /Id# 169125|British Columbia Fraser Clinical Trials Inc /Id# 169116|New Brunswick Qeii Health Sciences Centre /Id# 169121|Ontario London Health Sciences Centre /Id# 169117|Quebec Hopital Charles-Lemoyne /Id# 169119|Hospital Las Higueras /Id# 167094|Region Metropolitana De Santiago Complejo Asistencial Dr. Sotero Del Rio /Id# 169386|ValparaÃ­so Centro De Investigaciones ClÃ­nicas ViÃ±a Del Mar /Id# 203606|Instituto De Coloproctologia /Id# 158742|Grad Zagreb Klinicka Bolnica Dubrava Zagreb /Id# 157598|Klinicki Bolnicki Centar Split /Id# 157596|Osjecko-Baranjska Zupanija Klinicki Bolnicki Centar Osijek /Id# 157595|Hvidovre Hospital /Id# 205093|Nordjylland Aarhus University Hospital /Id# 200072|SjÃ¦lland Sjaellands Universitets Hospit /Id# 200073|Syddanmark Svendborg Sygehus, Sygehusenhe /Id# 200071|University Of Alexandria /Id# 201824|Alpes-Maritimes Chu De Nice-Hopital L'Archet Ii /Id# 207881|Chu Amiens Picardie - Site Sud /Id# 207880|Gironde HÃ´pital Haut-LÃ©vÃªque /Id# 207883|Hopital Beaujon /Id# 207876|Loire Chu De Saint Etienne - Hopital Nord /Id# 207882|Baden-Wuerttemberg Universitatsklinikum Mannheim /Id# 162039|Bayern Universitaetsklinikum Erlangen /Id# 159373|CharitÃ© UniversitÃ¤tsmedizin Campus Mitte /Id# 163695|Nordrhein-Westfalen Uniklinik Koln /Id# 164993|Schleswig-Holstein Univ Hosp Schleswig-Holstein /Id# 159379|Thueringen Universitaetsklinikum Ulm /Id# 164994|Attiki General Hospital Of Athens Laiko /Id# 206438|General Hospital Of Chest Diseases Of Athens \"Sotiria\" /Id# 170910|Kriti Duplicate_University General Hospital Of Heraklion \"Pa.G.N.I\" /Id# 165327|Baranya Mohacsi Korhaz /Id# 205285|Borsod-Abauj-Zemplen Miskolci Semmelweis Korhaz Es /Id# 201281|Heves Bugat Pal Korhaz /Id# 202526|Magyar Honvedseg Egeszsegugyi Kozpont /Id# 157338|Pest Obudai Egeszsegugyi Kozpont /Id# 201921|Hadarom Soroka Medical Center /Id# 171093|Rambam Medical Center /Id# 171094|Tel-Aviv Rabin Medical Center /Id# 167402|Yerushalayim Hadassah Ein Kerem Medical Ctr /Id# 171092|Calabria UniversitÃ  Di Catanzaro \"Magna Graecia\" /Id# 200124|Emilia-Romagna Ospedale Sant Orsola Malpighi /Id# 155627|Lazio Policlinico Universitario Campus Bio-Medico /Id# 163994|Milano Istituto Clinico Humanitas /Id# 155626|Ospedali Riuniti Universita /Id# 206809|Sicilia A.O. Per L'Emergenza Cannizzaro /Id# 164039|Verona Ospedale Classificato Equiparato Sacro Cuore-Don Calabria /Id# 164029|Aichi Aichi Medical University Hosp /Id# 164227|Chiba Toho University Sakura Med Ctr /Id# 164219|Fukuoka Kurume University Hospital /Id# 164237|Gunma National Hospital Organization Takasaki General Medical Center /Id# 164312|Hiroshima Nho Fukuyama Medical Center /Id# 164315|Hiroshima University Hospital /Id# 164240|Hokkaido Asahikawa Medical University Hospital /Id# 164324|Hyogo Aoyama Clinic /Id# 164236|Ishikawa Kanazawa University Ho /Id# 169221|Kanagawa Ofuna Chuo Hospital /Id# 169296|Mie Mie University Hospital /Id# 203635|Miyagi Tohoku University Hospital /Id# 164276|Nagasaki Nagasaki University Hospital /Id# 205326|Saitama Tokito Clinic /Id# 164218|Shiga Shiga Univ Med Science Hosp /Id# 164323|Tokyo Medical Hospital Of Tokyo Medical And Dental University /Id# 164225|Yamagata Yamagata University Hospital /Id# 171481|Riga East Clinical Univ Hosp /Id# 160204|Kaunas Hospital Of Lithuanian Univers /Id# 201142|Klaipeda Seamens Hospital /Id# 201143|/Id# 200633|Selangor Ukm Medical Centre /Id# 200634|Jalisco Ibiomed Guadalajara /Id# 206514|Jm Research /Id# 206518|Elisabeth Tweesteden Ziekenhuis /Id# 163738|Noord-Holland Academisch Medisch Centrum /Id# 157965|, Canterbury Christchurch Hospital /Id# 205337|Wellington Hospital (Capital And Coast District Health Board) /Id# 205338|Kujawsko-Pomorskie Szpital Uniwersytecki Nr 2 Im. Dr J.Biziela W Bydgoszczy /Id# 170280|Lodzkie Nzoz Centrum Medyczne-Szpital Sw.Rodziny Sp.Zo.O. /Id# 170288|Malopolskie Centrum Medyczne Plejady /Id# 170635|Mazowieckie Centrum Zdrowia Mdm /Id# 170283|Zachodniopomorskie Endoskopia Sp. Z O.O. /Id# 170284|Chuc- Centro Hospitalar E Univ /Id# 166050|Faro Centro Hospitalar Do Algarve - Hospital De PortimÃ£o /Id# 166563|Lisboa Centro Hosp De Lisboa Central /Id# 165578|Setubal Hospital Garcia De Orta, E.P.E /Id# 165579|Institutul Clinic Fundeni /Id# 171258|Southern California Res. Ctr. /Id# 169659|/Id# 200153|Sumadijski Okrug Clinical Center Kragujevac /Id# 156879|Fn S Poliklinikou F.D. Rooseve /Id# 164348|, Free State Farmovs Integrated Research Solutions /Id# 207538|, Gauteng Wits Clinical Research Site /Id# 171140|, Western Cape Allergy & Immunology (Aiu) /Id# 171439|Dr Jp Wright /Id# 171142|Hospital Universitario Parc Tauli /Id# 159473|Pontevedra Hospital Alvaro Cunqueiro /Id# 167359|Su Molndal. /Id# 202841|Vastra Gotalands Lan AlingsÃ¥s Lasarett /Id# 202075|University Hospital Zurich /Id# 202908|Ankara Univ Medical Faculty /Id# 167205|Kayseri Erciyes University Medical Fac /Id# 171283|Kyivska Oblast Medical Centre Of \"Ukrainian German Antiulcer Gastroenterology Centre Byk-Kyiv\" /Id# 203740|Regional Clinical Hospital /Id# 203366|Vinnytska Oblast Vinnytsia Pirogov Reg Clin Hos /Id# 204371|, Devon Rd&E Hospital /Id# 157614|Barnsley Hospital Nhs Foundati /Id# 202771|University Arizona Cancer Ctr /Id# 158387|Ucsd /Id# 160430|Peak Gastroenterology Associat /Id# 165838|Medical Research Ctr Ct /Id# 160287|South Lake Pain Institute, Inc /Id# 162859|Emory University Hospital /Id# 160570|University Of Chicago /Id# 160511|Indiana University /Id# 167250|Univ Kansas Med Ctr /Id# 161865|Delricht Research /Id# 206817|Mgh Digestive Health Center /Id# 164257|Center For Digestive Health /Id# 160300|Mayo Clinic - Rochester /Id# 200455|Quality Clinical Research Inc. /Id# 167312|Columbia Univ Medical Center /Id# 161929|Charlotte Gastro Hepatology /Id# 158543|Plains Clinical Research Center, Llc /Id# 169729|The Ohio State University - Columbus /Id# 164713|Digestive Disease Specialists /Id# 170777|University Of Pennsylvania /Id# 166262|Greenville Endoscopy Center /Id# 160457|Gastro One /Id# 160373|Inquest Clinical Research /Id# 165686|Val R. Hansen /Id# 163004|Virginia Mason Medical Center /Id# 160432",{"$nulls":3},"AbbVie Inc.","2018-09-26","2020-05-25T16:36:30.186","2020-05-26T17:10:42.972","NCT03398135"]
["5ecbf40e11702c1b1b916a49","NCT03398135","2018-11-02","AbbVie","ABBV","Recruiting","A Study to Assess the Efficacy and Safety of Risankizumab in Subjects With Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065","Risankizumab","IL23 Inhibitor","Yes","['Risankizumab']","No",null,"Phase 3",6,760,"Anticipated","2018-08-28","2022-12-04",{"$nulls":5},"The purpose of this study is to evaluate safety and efficacy of risankizumab in subjects with ulcerative colitis (UC) in subjects who responded to induction treatment with risankizumab in a prior AbbVie study of risankizumab in UC.\n\nThis study consists of three sub-studies: Substudy 1 is a 52-week, randomized, double-blind, placebo-controlled maintenance study; Substudy 2 is 52-week, randomized, exploratory maintenance study; and Substudy 3 is an open-label long-term extension study for subjects who completed Substudy 1 or 2.",null,"A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects With Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065","M16-066","Ulcerative Colitis (UC)","Colitis|Colitis, Ulcerative","Gastrointestinal Diseases","Gastrointestinal","Experimental|Placebo Comparator","Substudy 2: Open-label Risankizumab Dose 1|Substudy 1: Double-blind Risankizumab Dose 2|Substudy 2: Open-label Risankizumab Dose 2|Substudy 3: Open-label Extension Risankizumab|Substudy 1: Double-blind Placebo|Substudy 1: Double-blind Risankizumab Dose 1","Participants randomized to receive risankizumab dose 1 administered by subcutaneous (SC) injection.|Participants randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection.|Participants who completed Sub-study 1 or 2 receive open-label risankizumab in Sub-study 3.|Participants randomized to receive placebo for risankizumab administered by subcutaneous (SC) injection.","Drug","risankizumab|placebo for risankizumab","subcutaneous (SC) injection","ABBV-066 | BI 655066","Substudy 2: Open-label Risankizumab Dose 1|Substudy 1: Double-blind Risankizumab Dose 2|Substudy 2: Open-label Risankizumab Dose 2|Substudy 3: Open-label Extension Risankizumab|Substudy 1: Double-blind Placebo|Substudy 1: Double-blind Risankizumab Dose 1","\n\n * Subjects who have completed Study M16-065 or Study M16-067 and have achieved clinical response\n\n","\n\n * Subjects who have a known hypersensitivity to risankizumab or the excipients of any of the study drugs or the ingredients of chinese hamster ovary (CHO) or had an adverse event (AE) during Studies M16-065 or M16-067 that in the Investigator's judgment makes the subject unsuitable for this study\n * Subject is considered by the Investigator, for any reason, to be an unsuitable candidate for the study\n * Subject is not in compliance with prior and concomitant medication requirements throughout Studies M16-065 and M16-067",{"$nulls":4},"Actual","2018-01-12","Actual","Anticipated","2023-06-20","Anticipated","2018-10-01","2018-01-08","2018-01-08","2018-11-01","Yes","ABBV-066\nBI 655066","Interventional","Treatment","Parallel Assignment","Triple (Participant, Investigator, Outcomes Assessor)","Randomized","16 Years","80 Years","All",null,"No","Yes\nAbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2016-004676-22","EudraCT Number","Percentage of participants with clinical remission per adapted Mayo Score at Week 52","Clinical remission per Adapted Mayo Score.","Week 52","Percentage of participants with clinical remission per adapted Mayo Score at Week 52 in subjects with a clinical remission at Week 0|Percentage of participants who discontinued corticosteroid use at Week 52 in subjects who were taking steroids at Baseline (of induction)|Percentage of participants who discontinued corticosteroid use, remained corticosteroid free for 90 days, and achieved clinical remission per adapted Mayo Score at Week 52 in subjects taking steroids at Baseline (of induction).|Percentage of participants with endoscopic remission at Week 52|Ulcerative Colitis Symptom Questionnaire (UC-SQ): Change from Week 0 to Week 52|Percentage of participants with Ulcerative Colitis (UC)-related surgeries through Week 52|Percentage of participants with hospitalization through Week 52|36-Item Short Form Health Status Survey (SF-36): Change from Week 0 to Week 52|Inflammatory Bowel Disease Questionnaire (IBDQ): Change from Week 0 to Week 52|Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue): Change from Week 0 to Week 52|Percentage of participants with endoscopic improvement at Week 52|Percentage of participants with clinical remission per full Mayo Score at Week 52 in subjects with a full Mayo Score of 6 to 12 at Baseline (of Induction)|Percentage of participants with endoscopic improvement at Week 52 in participants with endoscopic improvement at Week 0|Percentage of participants with clinical response per adapted Mayo score at Week 52|Percentage of participants with histologic remission at Week 52|Percentage of participants with mucosal healing at Week 52","Clinical remission per Adapted Mayo Score.|Participants who discontinued corticosteroid use.|Endoscopic remission per endoscopy subscore.|The UC-SQ is a patient questionnaire to assess severity of ulcerative colitis symptoms.|Participants who underwent surgery related to UC.|Participants with an event that results in admission to the hospital.|The SF-36 is an indicator of overall health status.|The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.|The FACIT-Fatigue is a validated tool that measures an individual's level of fatigue during their usual daily activities over the past week.|Endoscopic improvement per endoscopy subscore.|Clinical remission per full Mayo Score.|Clinical response per Adapted Mayo score.|Histologic remission per Geboes Score.|Mucosal healing defined as endoscopic and histologic remission.","Week 52|Week 0, Week 52|52 weeks","abbvieclinicaltrials@abbvie.com","ABBVIE CALL CENTER","847.283.8955",{"$cut":{"chars":21608,"head":"Buenos Aires, Argentina, 1431 Instituto Medico Cer /Id# 168685Quilmes, Argentina, 1878 Sanatorio 9 De Julio S.A. /Id# 167803San Miguel De Tucuman, Argentina, 4000 Hopital Centenario /Id# 170896Santa Fe, Argentina, 2000|Graz, Austria, 8036 Lkh Salzburg And Paracelsus /Id# 200686Salzburg, Austria, 5020|St. PÃ¶lten, Niederoesterreich, Austria, 3100|Vienna, Wien, Austria, 1090|Brussels, Bruxelles-Capitale, Belgium, 1070 Cliniques Universitaires Saint Luc /Id# 200260Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200|Liege, Liege, Belgium, 4000|Gent, Oost-Vlaanderen, Belgium, 9000|Jette, Brussels, Belgium, 1090 Uz Leuven /Id# 170829Leuven, Belgium, 3000 Clinique St Joseph /Id# 200255Liege, Belgium, 4000 Az-Delta /Id# 200258Roeselare, Belgium, 8800 Chu Dinant Godinne - Ucl Namur /Id# 200259Yvoir, Belgium, 5530|Goiania, Goias, Brazil, 74535-170|Curitiba, Parana, Brazil, 80810-040|Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903|Botucatu, Sao Paulo, Brazil, 18618-686 Hospital Das Clinicas Da Faculdade De Medicina De RibeirÃ£o Preto - Usp /Id# 157668RibeirÃ£o Preto, Sao Paulo, Brazil, 14048-900 Faculdade De Medicina Do Abc /Id# 163993Santo AndrÃ©, Sao Paulo, Brazil, 09060-870 Kaiser Clinica E Hospital Dia /Id# 157686Sao Jose Do Rio Preto, Sao Paulo, Brazil, 15015-110|Sliven, Bulgaria, 8800 Ii Mhat - Sofia /Id# 200794Sofia, Bulgaria, 1202 Umhat Tsaritsa Joanna - Isul /Id# 207908Sofia, Bulgaria, 1527 Umhat Sv. 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Klinikum Graz /Id# 169052|Niederoesterreich UniversitÃ¤tsklinikum St.PÃ¶lten /Id# 169049|Wien Medical University Of Vienna /Id# 169051|Bruxelles-Capitale Cub Hospital Erasme /Id# 200256|Liege Chu De Liege /Id# 200257|Oost-Vlaanderen Uz Gent /Id# 200261|Uz Brussels /Id# 164175|Goias Instituto Goiano De Gastroenterologia /Id# 157683|Parana Hospital Nossa Senhora Das GraÃ§as /Id# 157677|Rio Grande Do Sul Hospital De Clinicas De Porto Alegre /Id# 157670|Sao Paulo Upeclin Fmb - Unesp /Id# 157691|Mbal \"Hadzhi Dimitar\" /Id# 207947|Alberta University Of Calgary /Id# 169125|British Columbia Fraser Clinical Trials Inc /Id# 169116|New Brunswick Qeii Health Sciences Centre /Id# 169121|Ontario London Health Sciences Centre /Id# 169117|Quebec Hopital Charles-Lemoyne /Id# 169119|Hospital Las Higueras /Id# 167094|Region Metropolitana De Santiago Complejo Asistencial Dr. Sotero Del Rio /Id# 169386|ValparaÃ­so Centro De Investigaciones ClÃ­nicas ViÃ±a Del Mar /Id# 203606|Instituto De Coloproctologia /Id# 158742|Grad Zagreb Klinicka Bolnica Dubrava Zagreb /Id# 157598|Klinicki Bolnicki Centar Split /Id# 157596|Osjecko-Baranjska Zupanija Klinicki Bolnicki Centar Osijek /Id# 157595|Hvidovre Hospital /Id# 205093|Midtjylland Aarhus University Hospital /Id# 200072|SjÃ¦lland Sjaellands Universitets Hospit /Id# 200073|Syddanmark Svendborg Sygehus, Sygehusenhe /Id# 200071|University Of Alexandria /Id# 201824|Alpes-Maritimes Chu De Nice-Hopital L'Archet Ii /Id# 207881|Chu Amiens Picardie - Site Sud /Id# 207880|Gironde HÃ´pital Haut-LÃ©vÃªque /Id# 207883|Hopital Beaujon /Id# 207876|Loire Chu De Saint Etienne - Hopital Nord /Id# 207882|Baden-Wuerttemberg Universitatsklinikum Mannheim /Id# 162039|Bayern Universitaetsklinikum Erlangen /Id# 159373|CharitÃ© UniversitÃ¤tsmedizin Campus Mitte /Id# 163695|Nordrhein-Westfalen Uniklinik Koln /Id# 164993|Schleswig-Holstein Univ Hosp Schleswig-Holstein /Id# 159379|Thueringen Universitaetsklinikum Ulm /Id# 164994|Attiki General Hospital Of Athens Laiko /Id# 206438|General Hospital Of Chest Diseases Of Athens \"Sotiria\" /Id# 170910|Baranya Mohacsi Korhaz /Id# 205285|Borsod-Abauj-Zemplen Miskolci Semmelweis Korhaz Es /Id# 201281|Heves Bugat Pal Korhaz /Id# 202526|Magyar Honvedseg Egeszsegugyi Kozpont /Id# 157338|Pest Obudai Egeszsegugyi Kozpont /Id# 201921|Hadarom Soroka Medical Center /Id# 171093|Rambam Medical Center /Id# 171094|Tel-Aviv Rabin Medical Center /Id# 167402|Yerushalayim Hadassah Ein Kerem Medical Ctr /Id# 171092|Calabria UniversitÃ  Di Catanzaro \"Magna Graecia\" /Id# 200124|Emilia-Romagna Ospedale Sant Orsola Malpighi /Id# 155627|Lazio Policlinico Universitario Campus Bio-Medico /Id# 163994|Milano Istituto Clinico Humanitas /Id# 155626|Ospedali Riuniti Universita /Id# 206809|Sicilia A.O. Per L'Emergenza Cannizzaro /Id# 164039|Verona Ospedale Classificato Equiparato Sacro Cuore-Don Calabria /Id# 164029|Aichi Aichi Medical University Hosp /Id# 164227|Chiba Toho University Sakura Medical Center /Id# 164219|Fukuoka Kurume University Hospital /Id# 164237|Gifu Gifu University Hospital /Id# 208490|Gunma National Hospital Organization Takasaki General Medical Center /Id# 164312|Hiroshima Nho Fukuyama Medical Center /Id# 164315|Hiroshima University Hospital /Id# 164240|Hokkaido Asahikawa Medical University Hospital /Id# 164324|Hyogo Aoyama Clinic /Id# 164236|Ishikawa Kanazawa University Ho /Id# 169221|Kanagawa Gokeikai Ofuna Chuo Hospital /Id# 169296|Mie Mie University Hospital /Id# 203635|Miyagi Tohoku University Hospital /Id# 164276|Nagasaki Nagasaki University Hospital /Id# 205326|Saitama Tokito Clinic /Id# 164218|Shiga Shiga Univ Med Science Hosp /Id# 164323|Tokyo Medical Hospital Of Tokyo Medical And Dental University /Id# 164225|Yamagata Yamagata University Hospital /Id# 171481|Riga East Clinical Univ Hosp /Id# 160204|Kaunas Hospital Of Lithuanian Univers /Id# 201142|Klaipeda Seamens Hospital /Id# 201143|/Id# 200633|Selangor Ukm Medical Centre /Id# 200634|Jalisco InvestigaciÃ³n BiomÃ©dica Para El Desarrollo De FÃ¡rmacos, S.A. 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Rooseve /Id# 164348|, Free State Farmovs Integrated Research Solutions /Id# 207538|, Gauteng Wits Clinical Research Site /Id# 171140|, Western Cape Allergy & Immunology (Aiu) /Id# 171439|Dr Jp Wright /Id# 171142|Hospital Universitario Parc Tauli /Id# 159473|Pontevedra Hospital Alvaro Cunqueiro /Id# 167359|Su Molndal. /Id# 202841|Vastra Gotalands Lan AlingsÃ¥s Lasarett /Id# 202075|University Hospital Zurich /Id# 202908|Ankara Univ Medical Faculty /Id# 167205|Kayseri Erciyes University Medical Fac /Id# 171283|Kyivska Oblast Medical Centre Of \"Ukrainian German Antiulcer Gastroenterology Centre Byk-Kyiv\" /Id# 203740|Regional Clinical Hospital /Id# 203366|Vinnytska Oblast Vinnytsia Pirogov Reg Clin Hos /Id# 204371|, Devon Rd&E Hospital /Id# 157614|Barnsley Hospital Nhs Foundati /Id# 202771|Ucsd /Id# 160430|Peak Gastroenterology Associat /Id# 165838|Connecticut Gi /Id# 164712|South Lake Pain Institute, Inc /Id# 162859|Emory University Hospital /Id# 160570|University Of Chicago /Id# 160511|Indiana University /Id# 167250|Univ Kansas Med Ctr /Id# 161865|Delricht Research /Id# 206817|Mgh Digestive Health Center /Id# 164257|Center For Digestive Health /Id# 160300|Mayo Clinic - Rochester /Id# 200455|Quality Clinical Research Inc. /Id# 167312|Columbia Univ Medical Center /Id# 161929|Carolinas Medical Center /Id# 158543|Plains Clinical Research Center, Llc /Id# 169729|Cleveland Clinic Foundation /Id# 209235|Digestive Disease Specialists /Id# 170777|University Of Pennsylvania /Id# 166262|Gastroenterology Associates, P.A. /Id# 160457|Gastro One /Id# 160373|Inquest Clinical Research /Id# 165686|Hp Clinical Research /Id# 163004|Virginia Mason Medical Center /Id# 160432",{"$nulls":3},"AbbVie Inc.","2018-11-01","2020-05-25T16:36:30.192","2020-05-26T17:10:42.972","NCT03398135"]
["5ecbf40efeab101b15530869","NCT03398135","2019-01-15","AbbVie","ABBV","Recruiting","A Study to Assess the Efficacy and Safety of Risankizumab in Subjects With Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065","Risankizumab","IL23 Inhibitor","Yes","['Risankizumab']","No",null,"Phase 3",6,760,"Anticipated","2018-08-28","2022-12-04",{"$nulls":5},"The purpose of this study is to evaluate safety and efficacy of risankizumab in subjects with ulcerative colitis (UC) in subjects who responded to induction treatment with risankizumab in a prior AbbVie study of risankizumab in UC.\n\nThis study consists of three sub-studies: Substudy 1 is a 52-week, randomized, double-blind, placebo-controlled maintenance study; Substudy 2 is 52-week, randomized, exploratory maintenance study; and Substudy 3 is an open-label long-term extension study for subjects who completed Substudy 1 or 2.",null,"A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects With Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065","M16-066","Ulcerative Colitis (UC)","Colitis|Colitis, Ulcerative","Gastrointestinal Diseases","Gastrointestinal","Experimental|Placebo Comparator","Substudy 2: Open-label Risankizumab Dose 1|Substudy 1: Double-blind Risankizumab Dose 2|Substudy 2: Open-label Risankizumab Dose 2|Substudy 3: Open-label Extension Risankizumab|Substudy 1: Double-blind Placebo|Substudy 1: Double-blind Risankizumab Dose 1","Participants randomized to receive risankizumab dose 1 administered by subcutaneous (SC) injection.|Participants randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection.|Participants who completed Sub-study 1 or 2 receive open-label risankizumab in Sub-study 3.|Participants randomized to receive placebo for risankizumab administered by subcutaneous (SC) injection.","Drug","risankizumab|placebo for risankizumab","subcutaneous (SC) injection","ABBV-066 | BI 655066","Substudy 2: Open-label Risankizumab Dose 1|Substudy 1: Double-blind Risankizumab Dose 2|Substudy 2: Open-label Risankizumab Dose 2|Substudy 3: Open-label Extension Risankizumab|Substudy 1: Double-blind Placebo|Substudy 1: Double-blind Risankizumab Dose 1","\n\n * Subjects who have completed Study M16-065 or Study M16-067 and have achieved clinical response\n\n","\n\n * Subjects who have a known hypersensitivity to risankizumab or the excipients of any of the study drugs or the ingredients of chinese hamster ovary (CHO) or had an adverse event (AE) during Studies M16-065 or M16-067 that in the Investigator's judgment makes the subject unsuitable for this study\n * Subject is considered by the Investigator, for any reason, to be an unsuitable candidate for the study\n * Subject is not in compliance with prior and concomitant medication requirements throughout Studies M16-065 and M16-067",{"$nulls":4},"Actual","2018-01-12","Actual","Anticipated","2024-06-30","Anticipated","2019-01-01","2018-01-08","2018-01-08","2019-01-11","Yes","ABBV-066\nBI 655066","Interventional","Treatment","Parallel Assignment","Triple (Participant, Investigator, Outcomes Assessor)","Randomized","16 Years","80 Years","All",null,"No","Yes\nAbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2016-004676-22","EudraCT Number","Percentage of participants with clinical remission per adapted Mayo Score at Week 52","Clinical remission per Adapted Mayo Score.","Week 52","Percentage of participants with clinical remission per adapted Mayo Score at Week 52 in subjects with a clinical remission at Week 0|Percentage of participants who discontinued corticosteroid use at Week 52 in subjects who were taking steroids at Baseline (of induction)|Percentage of participants who discontinued corticosteroid use, remained corticosteroid free for 90 days, and achieved clinical remission per adapted Mayo Score at Week 52 in subjects taking steroids at Baseline (of induction).|Percentage of participants with endoscopic remission at Week 52|Ulcerative Colitis Symptom Questionnaire (UC-SQ): Change from Week 0 to Week 52|Percentage of participants with Ulcerative Colitis (UC)-related surgeries through Week 52|Percentage of participants with hospitalization through Week 52|36-Item Short Form Health Status Survey (SF-36): Change from Week 0 to Week 52|Inflammatory Bowel Disease Questionnaire (IBDQ): Change from Week 0 to Week 52|Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue): Change from Week 0 to Week 52|Percentage of participants with endoscopic improvement at Week 52|Percentage of participants with clinical remission per full Mayo Score at Week 52 in subjects with a full Mayo Score of 6 to 12 at Baseline (of Induction)|Percentage of participants with endoscopic improvement at Week 52 in participants with endoscopic improvement at Week 0|Percentage of participants with clinical response per adapted Mayo score at Week 52|Percentage of participants with histologic remission at Week 52|Percentage of participants with mucosal healing at Week 52","Clinical remission per Adapted Mayo Score.|Participants who discontinued corticosteroid use.|Endoscopic remission per endoscopy subscore.|The UC-SQ is a patient questionnaire to assess severity of ulcerative colitis symptoms.|Participants who underwent surgery related to UC.|Participants with an event that results in admission to the hospital.|The SF-36 is an indicator of overall health status.|The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.|The FACIT-Fatigue is a validated tool that measures an individual's level of fatigue during their usual daily activities over the past week.|Endoscopic improvement per endoscopy subscore.|Clinical remission per full Mayo Score.|Clinical response per Adapted Mayo score.|Histologic remission per Geboes Score.|Mucosal healing defined as endoscopic and histologic remission.","Week 52|Week 0, Week 52|52 weeks","abbvieclinicaltrials@abbvie.com","ABBVIE CALL CENTER","847.283.8955",{"$cut":{"chars":22224,"head":"Buenos Aires, Argentina, 1431 Instituto Medico Cer /Id# 168685Quilmes, Argentina, 1878 Sanatorio 9 De Julio S.A. /Id# 167803San Miguel De Tucuman, Argentina, 4000|Rosario, Santa Fe, Argentina, 2000|Graz, Austria, 8036 Lkh Salzburg And Paracelsus /Id# 200686Salzburg, Austria, 5020|St. PÃ¶lten, Niederoesterreich, Austria, 3100|Vienna, Wien, Austria, 1090|Brussels, Bruxelles-Capitale, Belgium, 1070 Cliniques Universitaires Saint Luc /Id# 200260Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200|Liege, Liege, Belgium, 4000|Gent, Oost-Vlaanderen, Belgium, 9000|Jette, Brussels, Belgium, 1090 Uz Leuven /Id# 170829Leuven, Belgium, 3000 Clinique St Joseph /Id# 200255Liege, Belgium, 4000 Az-Delta /Id# 200258Roeselare, Belgium, 8800 Chu Dinant Godinne - Ucl Namur /Id# 200259Yvoir, Belgium, 5530|Goiania, Goias, Brazil, 74535-170|Curitiba, Parana, Brazil, 80810-040|Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903|Botucatu, Sao Paulo, Brazil, 18618-686 Hospital Das Clinicas Da Faculdade De Medicina De RibeirÃ£o Preto - Usp /Id# 157668RibeirÃ£o Preto, Sao Paulo, Brazil, 14048-900 Faculdade De Medicina Do Abc /Id# 163993Santo AndrÃ©, Sao Paulo, Brazil, 09060-870 Kaiser Clinica E Hospital Dia /Id# 157686Sao Jose Do Rio Preto, Sao Paulo, Brazil, 15015-110|Sliven, Bulgaria, 8800 Ii Mhat - Sofia /Id# 200794Sofia, Bulgaria, 1202 Umhat Tsaritsa Joanna - Isul /Id# 209978Sofia, Bulgaria, 1527 Umhat Sv. 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Klinikum Graz /Id# 169052|Niederoesterreich UniversitÃ¤tsklinikum St.PÃ¶lten /Id# 169049|Wien Medical University Of Vienna /Id# 169051|Bruxelles-Capitale Cub Hospital Erasme /Id# 200256|Liege Chu De Liege /Id# 200257|Oost-Vlaanderen Uz Gent /Id# 200261|Uz Brussels /Id# 164175|Goias Instituto Goiano De Gastroenterologia /Id# 157683|Parana Hospital Nossa Senhora Das GraÃ§as /Id# 157677|Rio Grande Do Sul Hospital De Clinicas De Porto Alegre /Id# 157670|Sao Paulo Upeclin Fmb - Unesp /Id# 157691|Mbal \"Hadzhi Dimitar\" /Id# 207947|Alberta University Of Calgary /Id# 169125|British Columbia Fraser Clinical Trials Inc /Id# 169116|New Brunswick Qeii Health Sciences Centre /Id# 169121|Ontario London Health Sciences Centre /Id# 169117|Quebec Hopital Charles-Lemoyne /Id# 169119|Hospital Las Higueras /Id# 167094|Region Metropolitana De Santiago Complejo Asistencial Dr. Sotero Del Rio /Id# 169386|ValparaÃ­so Centro De Investigaciones ClÃ­nicas ViÃ±a Del Mar /Id# 203606|Cundinamarca Corporacion Hospitalaria Juan Ciudad Sede Denominada Hospital Universitario Mayo /Id# 158736|Instituto De Coloproctologia /Id# 158742|Grad Zagreb Klinicka Bolnica Dubrava Zagreb /Id# 157598|Klinicki Bolnicki Centar Split /Id# 157596|Osjecko-Baranjska Zupanija Klinicki Bolnicki Centar Osijek /Id# 157595|Hovedstaden Bispebjerg Hospital /Id# 208953|Hvidovre Hospital /Id# 205093|SjÃ¦lland Sjaellands Universitets Hospit /Id# 200073|Syddanmark Svendborg Sygehus, Sygehusenhe /Id# 200071|University Of Alexandria /Id# 201824|Alpes-Maritimes Chu De Nice-Hopital L'Archet Ii /Id# 207881|Chu Amiens Picardie - Site Sud /Id# 207880|Gironde HÃ´pital Haut-LÃ©vÃªque /Id# 207883|Hopital Beaujon /Id# 207876|Loire Chu De Saint Etienne - Hopital Nord /Id# 207882|Baden-Wuerttemberg Universitatsklinikum Mannheim /Id# 162039|Bayern Universitaetsklinikum Erlangen /Id# 159373|Gastroenterologie Am Bayerisch /Id# 159380|Nordrhein-Westfalen Uniklinik Koln /Id# 164993|Schleswig-Holstein Univ Hosp Schleswig-Holstein /Id# 159379|Thueringen Universitaetsklinikum Ulm /Id# 164994|Attiki General Hospital Of Athens Laiko /Id# 206438|General Hospital Of Chest Diseases Of Athens \"Sotiria\" /Id# 170910|Baranya Mohacsi Korhaz /Id# 205285|Borsod-Abauj-Zemplen Miskolci Semmelweis Korhaz Es /Id# 201281|Heves Bugat Pal Korhaz /Id# 202526|Magyar Honvedseg Egeszsegugyi Kozpont /Id# 157338|Pest Obudai Egeszsegugyi Kozpont /Id# 201921|Hadarom Soroka Medical Center /Id# 171093|Rambam Medical Center /Id# 171094|Tel-Aviv Rabin Medical Center /Id# 167402|Yerushalayim Hadassah Ein Kerem Medical Ctr /Id# 171092|Calabria UniversitÃ  Di Catanzaro \"Magna Graecia\" /Id# 200124|Emilia-Romagna Ospedale Sant Orsola Malpighi /Id# 155627|Lazio Policlinico Universitario Campus Bio-Medico /Id# 163994|Milano Istituto Clinico Humanitas /Id# 155626|Ospedali Riuniti Universita /Id# 206809|Sicilia A.O. 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Rooseve /Id# 164348|Univ Medical Ctr Ljubljana /Id# 210628|, Free State Farmovs Integrated Research Solutions /Id# 207538|, Gauteng Wits Clinical Research Site /Id# 171140|, Western Cape Allergy & Immunology (Aiu) /Id# 171439|Dr Jp Wright /Id# 171142|Hospital Universitario Parc Tauli /Id# 159473|Pontevedra Hospital Alvaro Cunqueiro /Id# 167359|Su Molndal. /Id# 202841|Vastra Gotalands Lan AlingsÃ¥s Lasarett /Id# 202075|University Hospital Zurich /Id# 202908|Ankara Univ Medical Faculty /Id# 167205|Kayseri Erciyes University Medical Fac /Id# 171283|Kyivska Oblast Medical Centre Of \"Ukrainian German Antiulcer Gastroenterology Centre Byk-Kyiv\" /Id# 203740|Regional Clinical Hospital /Id# 203366|Vinnytska Oblast Vinnytsia Pirogov Reg Clin Hos /Id# 204371|, Devon Rd&E Hospital /Id# 157614|Barnsley Hospital Nhs Foundation Trust /Id# 202771|Ucsd /Id# 160430|Peak Gastroenterology Associat /Id# 165838|Connecticut Gi /Id# 164712|South Lake Pain Institute, Inc /Id# 162859|Emory University Hospital /Id# 160570|University Of Chicago /Id# 160511|Indiana University /Id# 167250|Cotton-O'Neil Clinical Res Ctr /Id# 160367|Delricht Research /Id# 206817|Mgh Digestive Health Center /Id# 164257|Center For Digestive Health /Id# 160300|Mayo Clinic - Rochester /Id# 200455|Quality Clinical Research Inc. /Id# 167312|Columbia Univ Medical Center /Id# 161929|Carolinas Medical Center /Id# 158543|Plains Clinical Research Center, Llc /Id# 169729|Cleveland Clinic Foundation /Id# 209235|Digestive Disease Specialists /Id# 170777|University Of Pennsylvania /Id# 166262|Gastroenterology Associates, P.A. /Id# 160457|Gastro One /Id# 160373|Inquest Clinical Research /Id# 165686|Hp Clinical Research /Id# 163004|Pediatric Specialty Of Va /Id# 166819|Virginia Mason Medical Center /Id# 160432",{"$nulls":3},"AbbVie Inc.","2019-01-11","2020-05-25T16:36:30.530","2020-05-26T17:10:42.972","NCT03398135"]
["5ecbf40e307e3d1b1f8d9cc9","NCT03398135","2019-01-30","AbbVie","ABBV","Recruiting","A Study to Assess the Efficacy and Safety of Risankizumab in Subjects With Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065","Risankizumab","IL23 Inhibitor","Yes","['Risankizumab']","No",null,"Phase 3",6,760,"Anticipated","2018-08-28","2022-12-04",{"$nulls":5},"The purpose of this study is to evaluate safety and efficacy of risankizumab in subjects with ulcerative colitis (UC) in subjects who responded to induction treatment with risankizumab in a prior AbbVie study of risankizumab in UC.\n\nThis study consists of three sub-studies: Substudy 1 is a 52-week, randomized, double-blind, placebo-controlled maintenance study; Substudy 2 is 52-week, randomized, exploratory maintenance study; and Substudy 3 is an open-label long-term extension study for subjects who completed Substudy 1 or 2.",null,"A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects With Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065","M16-066","Ulcerative Colitis (UC)","Colitis|Colitis, Ulcerative","Gastrointestinal Diseases","Gastrointestinal","Experimental|Placebo Comparator","Substudy 2: Open-label Risankizumab Dose 1|Substudy 1: Double-blind Risankizumab Dose 2|Substudy 2: Open-label Risankizumab Dose 2|Substudy 3: Open-label Extension Risankizumab|Substudy 1: Double-blind Placebo|Substudy 1: Double-blind Risankizumab Dose 1","Participants randomized to receive risankizumab dose 1 administered by subcutaneous (SC) injection.|Participants randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection.|Participants who completed Sub-study 1 or 2 receive open-label risankizumab in Sub-study 3.|Participants randomized to receive placebo for risankizumab administered by subcutaneous (SC) injection.","Drug","risankizumab|placebo for risankizumab","subcutaneous (SC) injection","ABBV-066 | BI 655066","Substudy 2: Open-label Risankizumab Dose 1|Substudy 1: Double-blind Risankizumab Dose 2|Substudy 2: Open-label Risankizumab Dose 2|Substudy 3: Open-label Extension Risankizumab|Substudy 1: Double-blind Placebo|Substudy 1: Double-blind Risankizumab Dose 1","\n\n * Subjects who have completed Study M16-065 or Study M16-067 and have achieved clinical response\n\n","\n\n * Subjects who have a known hypersensitivity to risankizumab or the excipients of any of the study drugs or the ingredients of chinese hamster ovary (CHO) or had an adverse event (AE) during Studies M16-065 or M16-067 that in the Investigator's judgment makes the subject unsuitable for this study\n * Subject is considered by the Investigator, for any reason, to be an unsuitable candidate for the study\n * Subject is not in compliance with prior and concomitant medication requirements throughout Studies M16-065 and M16-067",{"$nulls":4},"Actual","2018-01-12","Actual","Anticipated","2024-06-30","Anticipated","2019-01-01","2018-01-08","2018-01-08","2019-01-28","Yes","ABBV-066\nBI 655066","Interventional","Treatment","Parallel Assignment","Triple (Participant, Investigator, Outcomes Assessor)","Randomized","16 Years","80 Years","All",null,"No","Yes\nAbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2016-004676-22","EudraCT Number","Percentage of participants with clinical remission per adapted Mayo Score at Week 52","Clinical remission per Adapted Mayo Score.","Week 52","Percentage of participants with clinical remission per adapted Mayo Score at Week 52 in subjects with a clinical remission at Week 0|Percentage of participants who discontinued corticosteroid use at Week 52 in subjects who were taking steroids at Baseline (of induction)|Percentage of participants who discontinued corticosteroid use, remained corticosteroid free for 90 days, and achieved clinical remission per adapted Mayo Score at Week 52 in subjects taking steroids at Baseline (of induction).|Percentage of participants with endoscopic remission at Week 52|Ulcerative Colitis Symptom Questionnaire (UC-SQ): Change from Week 0 to Week 52|Percentage of participants with Ulcerative Colitis (UC)-related surgeries through Week 52|Percentage of participants with hospitalization through Week 52|36-Item Short Form Health Status Survey (SF-36): Change from Week 0 to Week 52|Inflammatory Bowel Disease Questionnaire (IBDQ): Change from Week 0 to Week 52|Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue): Change from Week 0 to Week 52|Percentage of participants with endoscopic improvement at Week 52|Percentage of participants with clinical remission per full Mayo Score at Week 52 in subjects with a full Mayo Score of 6 to 12 at Baseline (of Induction)|Percentage of participants with endoscopic improvement at Week 52 in participants with endoscopic improvement at Week 0|Percentage of participants with clinical response per adapted Mayo score at Week 52|Percentage of participants with histologic remission at Week 52|Percentage of participants with mucosal healing at Week 52","Clinical remission per Adapted Mayo Score.|Participants who discontinued corticosteroid use.|Endoscopic remission per endoscopy subscore.|The UC-SQ is a patient questionnaire to assess severity of ulcerative colitis symptoms.|Participants who underwent surgery related to UC.|Participants with an event that results in admission to the hospital.|The SF-36 is an indicator of overall health status.|The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.|The FACIT-Fatigue is a validated tool that measures an individual's level of fatigue during their usual daily activities over the past week.|Endoscopic improvement per endoscopy subscore.|Clinical remission per full Mayo Score.|Clinical response per Adapted Mayo score.|Histologic remission per Geboes Score.|Mucosal healing defined as endoscopic and histologic remission.","Week 52|Week 0, Week 52|52 weeks","abbvieclinicaltrials@abbvie.com","ABBVIE CALL CENTER","847.283.8955",{"$cut":{"chars":21809,"head":"Buenos Aires, Argentina, 1431 Instituto Medico Cer /Id# 168685Quilmes, Argentina, 1878 Sanatorio 9 De Julio S.A. /Id# 167803San Miguel De Tucuman, Argentina, 4000|Rosario, Santa Fe, Argentina, 2000|Graz, Austria, 8036 Lkh Salzburg And Paracelsus /Id# 200686Salzburg, Austria, 5020|St. PÃ¶lten, Niederoesterreich, Austria, 3100|Vienna, Wien, Austria, 1090|Brussels, Bruxelles-Capitale, Belgium, 1070 Cliniques Universitaires Saint Luc /Id# 200260Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200|Liege, Liege, Belgium, 4000|Gent, Oost-Vlaanderen, Belgium, 9000|Jette, Brussels, Belgium, 1090 Uz Leuven /Id# 170829Leuven, Belgium, 3000 Clinique St Joseph /Id# 200255Liege, Belgium, 4000 Az-Delta /Id# 200258Roeselare, Belgium, 8800 Chu Dinant Godinne - Ucl Namur /Id# 200259Yvoir, Belgium, 5530|Goiania, Goias, Brazil, 74535-170|Curitiba, Parana, Brazil, 80810-040|Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903|Botucatu, Sao Paulo, Brazil, 18618-686 Hospital Das Clinicas Da Faculdade De Medicina De RibeirÃ£o Preto - Usp /Id# 157668RibeirÃ£o Preto, Sao Paulo, Brazil, 14048-900 Faculdade De Medicina Do Abc /Id# 163993Santo AndrÃ©, Sao Paulo, Brazil, 09060-870 Kaiser Clinica E Hospital Dia /Id# 157686Sao Jose Do Rio Preto, Sao Paulo, Brazil, 15015-110|Sliven, Bulgaria, 8800 Ii Mhat - Sofia /Id# 200794Sofia, Bulgaria, 1202 Umhat Tsaritsa Joanna - Isul /Id# 209978Sofia, Bulgaria, 1527 Umhat Sv. 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["5ecbf40fe2561b1b11905d34","NCT03398135","2019-02-28","AbbVie","ABBV","Recruiting","A Study to Assess the Efficacy and Safety of Risankizumab in Subjects With Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065","Risankizumab","IL23 Inhibitor","Yes","['Risankizumab']","No",null,"Phase 3",6,760,"Anticipated","2018-08-28","2022-12-04",{"$nulls":5},"The purpose of this study is to evaluate safety and efficacy of risankizumab in subjects with ulcerative colitis (UC) in subjects who responded to induction treatment with risankizumab in a prior AbbVie study of risankizumab in UC.\n\nThis study consists of three sub-studies: Substudy 1 is a 52-week, randomized, double-blind, placebo-controlled maintenance study; Substudy 2 is 52-week, randomized, exploratory maintenance study; and Substudy 3 is an open-label long-term extension study for subjects who completed Substudy 1 or 2.",null,"A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects With Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065","M16-066","Ulcerative Colitis (UC)","Colitis|Colitis, Ulcerative","Gastrointestinal Diseases","Gastrointestinal","Experimental|Placebo Comparator","Substudy 2: Open-label Risankizumab Dose 1|Substudy 1: Double-blind Risankizumab Dose 2|Substudy 2: Open-label Risankizumab Dose 2|Substudy 3: Open-label Extension Risankizumab|Substudy 1: Double-blind Placebo|Substudy 1: Double-blind Risankizumab Dose 1","Participants randomized to receive risankizumab dose 1 administered by subcutaneous (SC) injection.|Participants randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection.|Participants who completed Sub-study 1 or 2 receive open-label risankizumab in Sub-study 3.|Participants randomized to receive placebo for risankizumab administered by subcutaneous (SC) injection.","Drug","risankizumab|placebo for risankizumab","subcutaneous (SC) injection","ABBV-066 | BI 655066","Substudy 2: Open-label Risankizumab Dose 1|Substudy 1: Double-blind Risankizumab Dose 2|Substudy 2: Open-label Risankizumab Dose 2|Substudy 3: Open-label Extension Risankizumab|Substudy 1: Double-blind Placebo|Substudy 1: Double-blind Risankizumab Dose 1","\n\n- Subjects who have completed Study M16-065 or Study M16-067 and have achieved clinical response\n\n","\n\n * Subjects who have a known hypersensitivity to risankizumab or the excipients of any of the study drugs or the ingredients of chinese hamster ovary (CHO) or had an adverse event (AE) during Studies M16-065 or M16-067 that in the Investigator's judgment makes the subject unsuitable for this study\n * Subject is considered by the Investigator, for any reason, to be an unsuitable candidate for the study\n * Subject is not in compliance with prior and concomitant medication requirements throughout Studies M16-065 and M16-067",{"$nulls":4},"Actual","2018-01-12","Actual","Anticipated","2024-06-30","Anticipated","2019-02-01","2018-01-08","2018-01-08","2019-02-27","Yes","ABBV-066\nBI 655066","Interventional","Treatment","Parallel Assignment","Triple (Participant, Investigator, Outcomes Assessor)","Randomized","16 Years","80 Years","All",null,"No","Yes\nAbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2016-004676-22","EudraCT Number","Percentage of participants with clinical remission per adapted Mayo Score at Week 52","Clinical remission per Adapted Mayo Score.","Week 52","Percentage of participants with clinical remission per adapted Mayo Score at Week 52 in subjects with a clinical remission at Week 0|Percentage of participants who discontinued corticosteroid use at Week 52 in subjects who were taking steroids at Baseline (of induction)|Percentage of participants who discontinued corticosteroid use, remained corticosteroid free for 90 days, and achieved clinical remission per adapted Mayo Score at Week 52 in subjects taking steroids at Baseline (of induction).|Percentage of participants with endoscopic remission at Week 52|Ulcerative Colititis Symptom Questionnaire (UC-SQ): Change from Week 0 to Week 52|Percentage of participants with Ulcerative Colitis (UC)-related surgeries through Week 52|Percentage of participants with hospitalization through Week 52|36-Item Short Form Health Status Survey (SF-36): Change from Week 0 to Week 52|Inflammatory Bowel Disease Questionnaire (IBDQ): Change from Week 0 to Week 52|Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue): Change from Week 0 to Week 52|Percentage of participants with endoscopic improvement at Week 52|Percentage of participants with clinical remission per full Mayo Score at Week 52 in subjects with a full Mayo Score of 6 to 12 at Baseline (of Induction)|Percentage of participants with endoscopic improvement at Week 52 in participants with endoscopic improvement at Week 0|Percentage of participants with clinical response per adapted Mayo score at Week 52|Percentage of participants with histologic remission at Week 52|Percentage of participants with mucosal healing at Week 52","Clinical remission per Adapted Mayo Score.|Participants who discontinued corticosteroid use.|Endoscopic remission per endoscopy subscore.|The UC-SQ is a patient questionnaire to assess severity of ulcerative colitis symptoms.|Participants who underwent surgery related to UC.|Participants with an event that results in admission to the hospital.|The SF-36 is an indicator of overall health status.|The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.|The FACIT-Fatigue is a validated tool that measures an individual's level of fatigue during their usual daily activities over the past week.|Endoscopic improvement per endoscopy subscore.|Clinical remission per full Mayo Score.|Clinical response per Adapted Mayo score.|Histologic remission per Geboes Score.|Mucosal healing defined as endoscopic and histologic remission.","Week 52|Week 0, Week 52|52 weeks","abbvieclinicaltrials@abbvie.com","ABBVIE CALL CENTER","847.283.8955",{"$cut":{"chars":22050,"head":"Buenos Aires, Argentina, 1431 Instituto Medico Cer /Id# 168685Quilmes, Argentina, 1878 Sanatorio 9 De Julio S.A. /Id# 167803San Miguel De Tucuman, Argentina, 4000|Rosario, Santa Fe, Argentina, 2000|Graz, Austria, 8036 Lkh Salzburg And Paracelsus /Id# 200686Salzburg, Austria, 5020|St. PÃ¶lten, Niederoesterreich, Austria, 3100|Vienna, Wien, Austria, 1090|Brussels, Bruxelles-Capitale, Belgium, 1070 Cliniques Universitaires Saint Luc /Id# 200260Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200|Liege, Liege, Belgium, 4000|Gent, Oost-Vlaanderen, Belgium, 9000|Jette, Brussels, Belgium, 1090 Uz Leuven /Id# 170829Leuven, Belgium, 3000 Clinique St Joseph /Id# 200255Liege, Belgium, 4000 Az-Delta /Id# 200258Roeselare, Belgium, 8800 Chu Dinant Godinne - Ucl Namur /Id# 200259Yvoir, Belgium, 5530|Goiania, Goias, Brazil, 74535-170|Curitiba, Parana, Brazil, 80810-040|Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903|Botucatu, Sao Paulo, Brazil, 18618-686 Hospital Das Clinicas Da Faculdade De Medicina De RibeirÃ£o Preto - Usp /Id# 157668RibeirÃ£o Preto, Sao Paulo, Brazil, 14048-900 Faculdade De Medicina Do Abc /Id# 163993Santo AndrÃ©, Sao Paulo, Brazil, 09060-870 Kaiser Clinica E Hospital Dia /Id# 157686Sao Jose Do Rio Preto, Sao Paulo, Brazil, 15015-110|Sliven, Bulgaria, 8800 Ii Mhat - Sofia /Id# 200794Sofia, Bulgaria, 1202 Umhat Tsaritsa Joanna - Isul /Id# 209978Sofia, Bulgaria, 1527 Umhat Sv. 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Z O.O. /Id# 170284|Chuc- Centro Hospitalar E Univ /Id# 166050|Faro Centro Hospitalar Do Algarve - Hospital De PortimÃ£o /Id# 166563|Lisboa Centro Hosp De Lisboa Central /Id# 165578|Setubal Hospital Garcia De Orta, E.P.E /Id# 165579|Institutul Clinic Fundeni /Id# 171258|Southern California Res. Ctr. /Id# 169659|/Id# 200153|Sumadijski Okrug Clinical Center Kragujevac /Id# 156879|Vojvodina Clinical Center Vojvodina /Id# 156876|Fn S Poliklinikou F.D. Rooseve /Id# 164348|Univ Medical Ctr Ljubljana /Id# 210628|, Free State Farmovs Integrated Research Solutions /Id# 207538|, Gauteng Wits Clinical Research Site /Id# 171140|, Western Cape Allergy & Immunology (Aiu) /Id# 171439|Dr Jp Wright /Id# 171142|Hospital Universitario Parc Tauli /Id# 159473|Pontevedra Hospital Alvaro Cunqueiro /Id# 167359|Su Molndal. /Id# 202841|Vastra Gotalands Lan AlingsÃ¥s Lasarett /Id# 202075|University Hospital Zurich /Id# 202908|Ankara Univ Medical Faculty /Id# 167205|Kayseri Erciyes University Medical Fac /Id# 171283|Kyivska Oblast Medical Centre Of \"Ukrainian German Antiulcer Gastroenterology Centre Byk-Kyiv\" /Id# 203740|Regional Clinical Hospital /Id# 203366|Vinnytska Oblast Vinnytsia Pirogov Reg Clin Hos /Id# 204371|, Devon Rd&E Hospital /Id# 157614|Barnsley Hospital Nhs Foundation Trust /Id# 202771|Ucsd /Id# 160430|Peak Gastroenterology Associat /Id# 165838|Medical Research Ctr Ct /Id# 160287|South Lake Pain Institute, Inc /Id# 162859|Emory University Hospital /Id# 160570|University Of Chicago /Id# 160511|Indiana University /Id# 167250|Cotton-O'Neil Clinical Res Ctr /Id# 160367|Houma Digestive Health Special /Id# 158377|Mgh Digestive Health Center /Id# 164257|Center For Digestive Health /Id# 160300|Mayo Clinic - Rochester /Id# 200455|Quality Clinical Research Inc. /Id# 167312|Comprehensive Digestive Instit /Id# 160176|Concorde Medical Group Pllc /Id# 211803|Carolinas Medical Center /Id# 158543|Plains Clinical Research Center, Llc /Id# 169729|Cleveland Clinic Foundation /Id# 209235|Digestive Disease Specialists /Id# 170777|University Of Pennsylvania /Id# 166262|Gastroenterology Associates, P.A. /Id# 160457|Gastro One /Id# 160373|Inquest Clinical Research /Id# 165686|Advanced Research Institute /Id# 160465|Pediatric Specialty Of Va /Id# 166819|Virginia Mason Medical Center /Id# 160432",{"$nulls":3},"AbbVie Inc.","2019-02-27","2020-05-25T16:36:31.051","2020-05-26T17:10:42.972","NCT03398135"]
["5ecbf40f11702c1b1b916a4a","NCT03398135","2019-03-22","AbbVie","ABBV","Recruiting","A Study to Assess the Efficacy and Safety of Risankizumab in Subjects With Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065","Risankizumab","IL23 Inhibitor","Yes","['Risankizumab']","No",null,"Phase 3",6,760,"Anticipated","2018-08-28","2022-12-04",{"$nulls":5},"The purpose of this study is to evaluate safety and efficacy of risankizumab in subjects with ulcerative colitis (UC) in subjects who responded to induction treatment with risankizumab in a prior AbbVie study of risankizumab in UC.\n\nThis study consists of three sub-studies: Substudy 1 is a 52-week, randomized, double-blind, placebo-controlled maintenance study; Substudy 2 is 52-week, randomized, exploratory maintenance study; and Substudy 3 is an open-label long-term extension study for subjects who completed Substudy 1 or 2.",null,"A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects With Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065","M16-066","Ulcerative Colitis (UC)","Colitis|Colitis, Ulcerative","Gastrointestinal Diseases","Gastrointestinal","Experimental|Placebo Comparator","Substudy 2: Open-label Risankizumab Dose 1|Substudy 1: Double-blind Risankizumab Dose 2|Substudy 2: Open-label Risankizumab Dose 2|Substudy 3: Open-label Extension Risankizumab|Substudy 1: Double-blind Placebo|Substudy 1: Double-blind Risankizumab Dose 1","Participants randomized to receive risankizumab dose 1 administered by subcutaneous (SC) injection.|Participants randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection.|Participants who completed Sub-study 1 or 2 receive open-label risankizumab in Sub-study 3.|Participants randomized to receive placebo for risankizumab administered by subcutaneous (SC) injection.","Drug","risankizumab|placebo for risankizumab","subcutaneous (SC) injection","ABBV-066 | BI 655066","Substudy 2: Open-label Risankizumab Dose 1|Substudy 1: Double-blind Risankizumab Dose 2|Substudy 2: Open-label Risankizumab Dose 2|Substudy 3: Open-label Extension Risankizumab|Substudy 1: Double-blind Placebo|Substudy 1: Double-blind Risankizumab Dose 1","\n\n * Subjects who have completed Study M16-065 or Study M16-067 and have achieved clinical response\n\n","\n\n * Subjects who have a known hypersensitivity to risankizumab or the excipients of any of the study drugs or the ingredients of chinese hamster ovary (CHO) or had an adverse event (AE) during Studies M16-065 or M16-067 that in the Investigator's judgment makes the subject unsuitable for this study\n * Subject is considered by the Investigator, for any reason, to be an unsuitable candidate for the study\n * Subject is not in compliance with prior and concomitant medication requirements throughout Studies M16-065 and M16-067",{"$nulls":4},"Actual","2018-01-12","Actual","Anticipated","2024-06-30","Anticipated","2019-03-01","2018-01-08","2018-01-08","2019-03-20","Yes","ABBV-066\nBI 655066","Interventional","Treatment","Parallel Assignment","Triple (Participant, Investigator, Outcomes Assessor)","Randomized","16 Years","80 Years","All",null,"No","Yes\nAbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2016-004676-22","EudraCT Number","Percentage of participants with clinical remission per adapted Mayo Score at Week 52","Clinical remission per Adapted Mayo Score.","Week 52","Percentage of participants with clinical remission per adapted Mayo Score at Week 52 in subjects with a clinical remission at Week 0|Percentage of participants who discontinued corticosteroid use at Week 52 in subjects who were taking steroids at Baseline (of induction)|Percentage of participants who discontinued corticosteroid use, remained corticosteroid free for 90 days, and achieved clinical remission per adapted Mayo Score at Week 52 in subjects taking steroids at Baseline (of induction).|Percentage of participants with endoscopic remission at Week 52|Ulcerative Colitis Symptom Questionnaire (UC-SQ): Change from Week 0 to Week 52|Percentage of participants with Ulcerative Colitis (UC)-related surgeries through Week 52|Percentage of participants with hospitalization through Week 52|36-Item Short Form Health Status Survey (SF-36): Change from Week 0 to Week 52|Inflammatory Bowel Disease Questionnaire (IBDQ): Change from Week 0 to Week 52|Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue): Change from Week 0 to Week 52|Percentage of participants with endoscopic improvement at Week 52|Percentage of participants with clinical remission per full Mayo Score at Week 52 in subjects with a full Mayo Score of 6 to 12 at Baseline (of Induction)|Percentage of participants with endoscopic improvement at Week 52 in participants with endoscopic improvement at Week 0|Percentage of participants with clinical response per adapted Mayo score at Week 52|Percentage of participants with histologic remission at Week 52|Percentage of participants with mucosal healing at Week 52","Clinical remission per Adapted Mayo Score.|Participants who discontinued corticosteroid use.|Endoscopic remission per endoscopy subscore.|The UC-SQ is a patient questionnaire to assess severity of ulcerative colitis symptoms.|Participants who underwent surgery related to UC.|Participants with an event that results in admission to the hospital.|The SF-36 is an indicator of overall health status.|The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.|The FACIT-Fatigue is a validated tool that measures an individual's level of fatigue during their usual daily activities over the past week.|Endoscopic improvement per endoscopy subscore.|Clinical remission per full Mayo Score.|Clinical response per Adapted Mayo score.|Histologic remission per Geboes Score.|Mucosal healing defined as endoscopic and histologic remission.","Week 52|Week 0, Week 52|52 weeks","abbvieclinicaltrials@abbvie.com","ABBVIE CALL CENTER","847.283.8955",{"$cut":{"chars":22075,"head":"Buenos Aires, Argentina, 1431 Instituto Medico Cer /Id# 168685Quilmes, Argentina, 1878 Sanatorio 9 De Julio S.A. /Id# 167803San Miguel De Tucuman, Argentina, 4000|Rosario, Santa Fe, Argentina, 2000|Graz, Austria, 8036 Lkh Salzburg And Paracelsus /Id# 200686Salzburg, Austria, 5020|St. PÃ¶lten, Niederoesterreich, Austria, 3100|Vienna, Wien, Austria, 1090|Brussels, Bruxelles-Capitale, Belgium, 1070 Cliniques Universitaires Saint Luc /Id# 200260Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200|Liege, Liege, Belgium, 4000|Gent, Oost-Vlaanderen, Belgium, 9000|Jette, Brussels, Belgium, 1090 Uz Leuven /Id# 170829Leuven, Belgium, 3000 Clinique St Joseph /Id# 200255Liege, Belgium, 4000 Az-Delta /Id# 200258Roeselare, Belgium, 8800 Chu Dinant Godinne - Ucl Namur /Id# 200259Yvoir, Belgium, 5530|Goiania, Goias, Brazil, 74535-170|Curitiba, Parana, Brazil, 80810-040|Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903|Botucatu, Sao Paulo, Brazil, 18618-686 Hospital Das Clinicas Da Faculdade De Medicina De RibeirÃ£o Preto - Usp /Id# 157668RibeirÃ£o Preto, Sao Paulo, Brazil, 14048-900 Faculdade De Medicina Do Abc /Id# 163993Santo AndrÃ©, Sao Paulo, Brazil, 09060-870 Kaiser Clinica E Hospital Dia /Id# 157686Sao Jose Do Rio Preto, Sao Paulo, Brazil, 15015-110|Sliven, Bulgaria, 8800 Ii Mhat - Sofia /Id# 200794Sofia, Bulgaria, 1202 Umhat Tsaritsa Joanna - Isul /Id# 209978Sofia, Bulgaria, 1527 Umhat Sv. 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Rooseve /Id# 164348|Univ Medical Ctr Ljubljana /Id# 210628|, Free State Farmovs Integrated Research Solutions /Id# 207538|, Gauteng Wits Clinical Research Site /Id# 171140|, Western Cape Allergy & Immunology (Aiu) /Id# 171439|Dr Jp Wright /Id# 171142|Hospital Universitario Parc Tauli /Id# 159473|Pontevedra Hospital Alvaro Cunqueiro /Id# 167359|Su Molndal. /Id# 202841|Vastra Gotalands Lan AlingsÃ¥s Lasarett /Id# 202075|University Hospital Zurich /Id# 202908|Ankara Univ Medical Faculty /Id# 167205|Kayseri Erciyes University Medical Fac /Id# 171283|Kyivska Oblast Medical Centre Of \"Ukrainian German Antiulcer Gastroenterology Centre Byk-Kyiv\" /Id# 203740|Regional Clinical Hospital /Id# 203366|, Devon Rd&E Hospital /Id# 157614|Barnsley Hospital Nhs Foundation Trust /Id# 202771|Ucsd /Id# 160430|Peak Gastroenterology Associat /Id# 165838|Medical Research Ctr Ct /Id# 160287|South Lake Pain Institute, Inc /Id# 162859|Emory University Hospital /Id# 160570|University Of Chicago /Id# 160511|Indiana University /Id# 167250|Cotton-O'Neil Clinical Res Ctr /Id# 160367|Houma Digestive Health Special /Id# 158377|Mgh Digestive Health Center /Id# 164257|Center For Digestive Health /Id# 160300|Mayo Clinic - Rochester /Id# 200455|Quality Clinical Research Inc. /Id# 167312|Comprehensive Digestive Instit /Id# 160176|Concorde Medical Group Pllc /Id# 211803|Carolinas Medical Center /Id# 158543|Plains Clinical Research Center, Llc /Id# 169729|Cleveland Clinic Foundation /Id# 209235|Digestive Disease Specialists /Id# 170777|University Of Pennsylvania /Id# 166262|Gastroenterology Associates, P.A. /Id# 160457|Gastro One /Id# 160373|Inquest Clinical Research /Id# 165686|Advanced Research Institute /Id# 160465|Pediatric Specialty Of Va /Id# 166819|Virginia Mason Medical Center /Id# 160432",{"$nulls":3},"AbbVie Inc.","2019-03-20","2020-05-25T16:36:31.115","2020-05-26T17:10:42.972","NCT03398135"]
["5ecbf40f307e3d1b1f8d9cca","NCT03398135","2019-04-19","AbbVie","ABBV","Recruiting","A Study to Assess the Efficacy and Safety of Risankizumab in Subjects With Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065","Risankizumab","IL23 Inhibitor","Yes","['Risankizumab']","No",null,"Phase 3",6,760,"Anticipated","2018-08-28","2022-12-04",{"$nulls":5},"The purpose of this study is to evaluate safety and efficacy of risankizumab in subjects with ulcerative colitis (UC) in subjects who responded to induction treatment with risankizumab in a prior AbbVie study of risankizumab in UC.\n\nThis study consists of three sub-studies: Substudy 1 is a 52-week, randomized, double-blind, placebo-controlled maintenance study; Substudy 2 is 52-week, randomized, exploratory maintenance study; and Substudy 3 is an open-label long-term extension study for subjects who completed Substudy 1 or 2.",null,"A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects With Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065","M16-066","Ulcerative Colitis (UC)","Colitis|Colitis, Ulcerative","Gastrointestinal Diseases","Gastrointestinal","Experimental|Placebo Comparator","Substudy 2: Open-label Risankizumab Dose 1|Substudy 1: Double-blind Risankizumab Dose 2|Substudy 2: Open-label Risankizumab Dose 2|Substudy 3: Open-label Extension Risankizumab|Substudy 1: Double-blind Placebo|Substudy 1: Double-blind Risankizumab Dose 1","Participants randomized to receive risankizumab dose 1 administered by subcutaneous (SC) injection.|Participants randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection.|Participants who completed Sub-study 1 or 2 receive open-label risankizumab in Sub-study 3.|Participants randomized to receive placebo for risankizumab administered by subcutaneous (SC) injection.","Drug","risankizumab|placebo for risankizumab","subcutaneous (SC) injection","ABBV-066 | BI 655066","Substudy 2: Open-label Risankizumab Dose 1|Substudy 1: Double-blind Risankizumab Dose 2|Substudy 2: Open-label Risankizumab Dose 2|Substudy 3: Open-label Extension Risankizumab|Substudy 1: Double-blind Placebo|Substudy 1: Double-blind Risankizumab Dose 1","\n\n * Subjects who have completed Study M16-065 or Study M16-067 and have achieved clinical response\n\n","\n\n * Subjects who have a known hypersensitivity to risankizumab or the excipients of any of the study drugs or the ingredients of chinese hamster ovary (CHO) or had an adverse event (AE) during Studies M16-065 or M16-067 that in the Investigator's judgment makes the subject unsuitable for this study\n * Subject is considered by the Investigator, for any reason, to be an unsuitable candidate for the study\n * Subject is not in compliance with prior and concomitant medication requirements throughout Studies M16-065 and M16-067",{"$nulls":4},"Actual","2018-01-12","Actual","Anticipated","2024-06-30","Anticipated","2019-04-01","2018-01-08","2018-01-08","2019-04-17","Yes","ABBV-066\nBI 655066","Interventional","Treatment","Parallel Assignment","Triple (Participant, Investigator, Outcomes Assessor)","Randomized","16 Years","80 Years","All",null,"No","Yes\nAbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2016-004676-22","EudraCT Number","Percentage of participants with clinical remission per adapted Mayo Score at Week 52","Clinical remission per Adapted Mayo Score.","Week 52","Percentage of participants with clinical remission per adapted Mayo Score at Week 52 in subjects with a clinical remission at Week 0|Percentage of participants who discontinued corticosteroid use at Week 52 in subjects who were taking steroids at Baseline (of induction)|Percentage of participants who discontinued corticosteroid use, remained corticosteroid free for 90 days, and achieved clinical remission per adapted Mayo Score at Week 52 in subjects taking steroids at Baseline (of induction).|Percentage of participants with endoscopic remission at Week 52|Ulcerative Colitis Symptom Questionnaire (UC-SQ): Change from Week 0 to Week 52|Percentage of participants with Ulcerative Colitis (UC)-related surgeries through Week 52|Percentage of participants with hospitalization through Week 52|36-Item Short Form Health Status Survey (SF-36): Change from Week 0 to Week 52|Inflammatory Bowel Disease Questionnaire (IBDQ): Change from Week 0 to Week 52|Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue): Change from Week 0 to Week 52|Percentage of participants with endoscopic improvement at Week 52|Percentage of participants with clinical remission per full Mayo Score at Week 52 in subjects with a full Mayo Score of 6 to 12 at Baseline (of Induction)|Percentage of participants with endoscopic improvement at Week 52 in participants with endoscopic improvement at Week 0|Percentage of participants with clinical response per adapted Mayo score at Week 52|Percentage of participants with histologic remission at Week 52|Percentage of participants with mucosal healing at Week 52","Clinical remission per Adapted Mayo Score.|Participants who discontinued corticosteroid use.|Endoscopic remission per endoscopy subscore.|The UC-SQ is a patient questionnaire to assess severity of ulcerative colitis symptoms.|Participants who underwent surgery related to UC.|Participants with an event that results in admission to the hospital.|The SF-36 is an indicator of overall health status.|The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.|The FACIT-Fatigue is a validated tool that measures an individual's level of fatigue during their usual daily activities over the past week.|Endoscopic improvement per endoscopy subscore.|Clinical remission per full Mayo Score.|Clinical response per Adapted Mayo score.|Histologic remission per Geboes Score.|Mucosal healing defined as endoscopic and histologic remission.","Week 52|Week 0, Week 52|52 weeks","abbvieclinicaltrials@abbvie.com","ABBVIE CALL CENTER","847.283.8955",{"$cut":{"chars":22127,"head":"Buenos Aires, Argentina, 1431 Instituto Medico Cer /Id# 168685Quilmes, Argentina, 1878 Sanatorio 9 De Julio S.A. /Id# 167803San Miguel De Tucuman, Argentina, 4000|Rosario, Santa Fe, Argentina, 2000|Graz, Austria, 8036 Lkh Salzburg And Paracelsus /Id# 200686Salzburg, Austria, 5020|St. PÃ¶lten, Niederoesterreich, Austria, 3100|Vienna, Wien, Austria, 1090|Brussels, Bruxelles-Capitale, Belgium, 1070 Cliniques Universitaires Saint Luc /Id# 200260Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200|Bonheiden, Belgium, 2820 Uz Brussels /Id# 164175Jette, Brussels, Belgium, 1090 Uz Leuven /Id# 170829Leuven, Belgium, 3000 Clinique St Joseph /Id# 200255Liege, Belgium, 4000 Az-Delta /Id# 200258Roeselare, Belgium, 8800 Chu Dinant Godinne - Ucl Namur /Id# 200259Yvoir, Belgium, 5530|Liege, Liege, Belgium, 4000|Gent, Oost-Vlaanderen, Belgium, 9000|Goiania, Goias, Brazil, 74535-170|Curitiba, Parana, Brazil, 80810-040|Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903|Botucatu, Sao Paulo, Brazil, 18618-686 Hospital Das Clinicas Da Faculdade De Medicina De RibeirÃ£o Preto - Usp /Id# 157668RibeirÃ£o Preto, Sao Paulo, Brazil, 14048-900 Faculdade De Medicina Do Abc /Id# 163993Santo AndrÃ©, Sao Paulo, Brazil, 09060-870 Kaiser Clinica E Hospital Dia /Id# 157686Sao Jose Do Rio Preto, Sao Paulo, Brazil, 15015-110|Sliven, Bulgaria, 8800 Ii Mhat - Sofia /Id# 200794Sofia, Bulgaria, 1202 Umhat Tsaritsa Joanna - Isul /Id# 209978Sofia, Bulgaria, 1527 Umhat Sv. 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["5ecbf40ffeab101b1553086a","NCT03398135","2019-05-20","AbbVie","ABBV","Recruiting","A Study to Assess the Efficacy and Safety of Risankizumab in Subjects With Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065","Risankizumab","IL23 Inhibitor","No",null,"No",null,"Phase 3",6,760,"Anticipated","2018-08-28","2022-12-04",{"$nulls":5},"The purpose of this study is to evaluate safety and efficacy of risankizumab in subjects with ulcerative colitis (UC) in subjects who responded to induction treatment with risankizumab in a prior AbbVie study of risankizumab in UC.\n\nThis study consists of three sub-studies: Substudy 1 is a 52-week, randomized, double-blind, placebo-controlled maintenance study; Substudy 2 is 52-week, randomized, exploratory maintenance study; and Substudy 3 is an open-label long-term extension study for subjects who completed Substudy 1 or 2.",null,"A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects With Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065","M16-066","Ulcerative Colitis (UC)","Colitis|Colitis, Ulcerative","Gastrointestinal Diseases","Gastrointestinal","Experimental|Placebo Comparator","Substudy 2: Open-label Risankizumab Dose 1|Substudy 1: Double-blind Risankizumab Dose 2|Substudy 2: Open-label Risankizumab Dose 2|Substudy 3: Open-label Extension Risankizumab|Substudy 1: Double-blind Placebo|Substudy 1: Double-blind Risankizumab Dose 1","Participants randomized to receive risankizumab dose 1 administered by subcutaneous (SC) injection.|Participants randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection.|Participants who completed Sub-study 1 or 2 receive open-label risankizumab in Sub-study 3.|Participants randomized to receive placebo for risankizumab administered by subcutaneous (SC) injection.","Drug","risankizumab|placebo for risankizumab","subcutaneous (SC) injection","ABBV-066 | BI 655066","Substudy 2: Open-label Risankizumab Dose 1|Substudy 1: Double-blind Risankizumab Dose 2|Substudy 2: Open-label Risankizumab Dose 2|Substudy 3: Open-label Extension Risankizumab|Substudy 1: Double-blind Placebo|Substudy 1: Double-blind Risankizumab Dose 1","\n\n * Subjects who have completed Study M16-065 or Study M16-067 and have achieved clinical response\n\n","\n\n * Subjects who have a known hypersensitivity to risankizumab or the excipients of any of the study drugs or the ingredients of chinese hamster ovary (CHO) or had an adverse event (AE) during Studies M16-065 or M16-067 that in the Investigator's judgment makes the subject unsuitable for this study\n * Subject is considered by the Investigator, for any reason, to be an unsuitable candidate for the study\n * Subject is not in compliance with prior and concomitant medication requirements throughout Studies M16-065 and M16-067",{"$nulls":4},"Actual","2018-01-12","Actual","Anticipated","2024-06-30","Anticipated","2019-05-01","2018-01-08","2018-01-08","2019-05-16","Yes","ABBV-066\nBI 655066","Interventional","Treatment","Parallel Assignment","Triple (Participant, Investigator, Outcomes Assessor)","Randomized","16 Years","80 Years","All",null,"No","Yes\nAbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2016-004676-22","EudraCT Number","Percentage of participants with clinical remission per adapted Mayo Score at Week 52","Clinical remission per Adapted Mayo Score.","Week 52","Percentage of participants with clinical remission per adapted Mayo Score at Week 52 in subjects with a clinical remission at Week 0|Percentage of participants who discontinued corticosteroid use at Week 52 in subjects who were taking steroids at Baseline (of induction)|Percentage of participants who discontinued corticosteroid use, remained corticosteroid free for 90 days, and achieved clinical remission per adapted Mayo Score at Week 52 in subjects taking steroids at Baseline (of induction).|Percentage of participants with endoscopic remission at Week 52|Ulcerative Colitis Symptom Questionnaire (UC-SQ): Change from Week 0 to Week 52|Percentage of participants with Ulcerative Colitis (UC)-related surgeries through Week 52|Percentage of participants with hospitalization through Week 52|36-Item Short Form Health Status Survey (SF-36): Change from Week 0 to Week 52|Inflammatory Bowel Disease Questionnaire (IBDQ): Change from Week 0 to Week 52|Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue): Change from Week 0 to Week 52|Percentage of participants with endoscopic improvement at Week 52|Percentage of participants with clinical remission per full Mayo Score at Week 52 in subjects with a full Mayo Score of 6 to 12 at Baseline (of Induction)|Percentage of participants with endoscopic improvement at Week 52 in participants with endoscopic improvement at Week 0|Percentage of participants with clinical response per adapted Mayo score at Week 52|Percentage of participants with histologic remission at Week 52|Percentage of participants with mucosal healing at Week 52","Clinical remission per Adapted Mayo Score.|Participants who discontinued corticosteroid use.|Endoscopic remission per endoscopy subscore.|The UC-SQ is a patient questionnaire to assess severity of ulcerative colitis symptoms.|Participants who underwent surgery related to UC.|Participants with an event that results in admission to the hospital.|The SF-36 is an indicator of overall health status.|The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.|The FACIT-Fatigue is a validated tool that measures an individual's level of fatigue during their usual daily activities over the past week.|Endoscopic improvement per endoscopy subscore.|Clinical remission per full Mayo Score.|Clinical response per Adapted Mayo score.|Histologic remission per Geboes Score.|Mucosal healing defined as endoscopic and histologic remission.","Week 52|Week 0, Week 52|52 weeks","abbvieclinicaltrials@abbvie.com","ABBVIE CALL CENTER","847.283.8955",{"$cut":{"chars":22345,"head":"Buenos Aires, Argentina, 1431 Instituto Medico Cer /Id# 168685Quilmes, Argentina, 1878 Sanatorio 9 De Julio S.A. /Id# 167803San Miguel De Tucuman, Argentina, 4000|Rosario, Santa Fe, Argentina, 2000|Graz, Austria, 8036 Lkh Salzburg And Paracelsus /Id# 200686Salzburg, Austria, 5020|St. PÃ¶lten, Niederoesterreich, Austria, 3100|Vienna, Wien, Austria, 1090|Brussels, Bruxelles-Capitale, Belgium, 1070 Cliniques Universitaires Saint Luc /Id# 200260Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200|Bonheiden, Belgium, 2820 Uz Brussels /Id# 164175Jette, Brussels, Belgium, 1090 Uz Leuven /Id# 170829Leuven, Belgium, 3000 Clinique St Joseph /Id# 200255Liege, Belgium, 4000 Az-Delta /Id# 200258Roeselare, Belgium, 8800 Chu Dinant Godinne - Ucl Namur /Id# 200259Yvoir, Belgium, 5530|Liege, Liege, Belgium, 4000|Gent, Oost-Vlaanderen, Belgium, 9000|Goiania, Goias, Brazil, 74535-170|Rio De Janeiro, Brazil, 21941-913|Curitiba, Parana, Brazil, 80810-040|Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903|Botucatu, Sao Paulo, Brazil, 18618-686 Hospital Das Clinicas Da Faculdade De Medicina De RibeirÃ£o Preto - Usp /Id# 157668RibeirÃ£o Preto, Sao Paulo, Brazil, 14048-900 Faculdade De Medicina Do Abc /Id# 163993Santo AndrÃ©, Sao Paulo, Brazil, 09060-870 Kaiser Clinica E Hospital Dia /Id# 157686Sao Jose Do Rio Preto, Sao Paulo, Brazil, 15015-110|Sliven, Bulgaria, 8800 Ii Mhat - Sofia /Id# 200794Sofia, Bulgaria, 1202 Umhat Tsaritsa Joanna - Isul /Id# 209978Sofia, Bulgaria, 1527 Umhat Sv. 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["5ecbf40ffe30261b1a048239","NCT03398135","2019-06-18","AbbVie","ABBV","Recruiting","A Study to Assess the Efficacy and Safety of Risankizumab in Subjects With Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065","Risankizumab","IL23 Inhibitor","No",null,"No",null,"Phase 3",6,760,"Anticipated","2018-08-28","2022-12-04",{"$nulls":5},"The purpose of this study is to evaluate safety and efficacy of risankizumab in subjects with ulcerative colitis (UC) in subjects who responded to induction treatment with risankizumab in a prior AbbVie study of risankizumab in UC.\n\nThis study consists of three sub-studies: Substudy 1 is a 52-week, randomized, double-blind, placebo-controlled maintenance study; Substudy 2 is 52-week, randomized, exploratory maintenance study; and Substudy 3 is an open-label long-term extension study for subjects who completed Substudy 1 or 2.",null,"A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects With Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065","M16-066","Ulcerative Colitis (UC)","Colitis|Colitis, Ulcerative","Gastrointestinal Diseases","Gastrointestinal","Experimental|Placebo Comparator","Substudy 2: Open-label Risankizumab Dose 1|Substudy 1: Double-blind Risankizumab Dose 2|Substudy 2: Open-label Risankizumab Dose 2|Substudy 3: Open-label Extension Risankizumab|Substudy 1: Double-blind Placebo|Substudy 1: Double-blind Risankizumab Dose 1","Participants randomized to receive risankizumab dose 1 administered by subcutaneous (SC) injection.|Participants randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection.|Participants who completed Sub-study 1 or 2 receive open-label risankizumab in Sub-study 3.|Participants randomized to receive placebo for risankizumab administered by subcutaneous (SC) injection.","Drug","risankizumab|placebo for risankizumab","subcutaneous (SC) injection","ABBV-066 | BI 655066","Substudy 2: Open-label Risankizumab Dose 1|Substudy 1: Double-blind Risankizumab Dose 2|Substudy 2: Open-label Risankizumab Dose 2|Substudy 3: Open-label Extension Risankizumab|Substudy 1: Double-blind Placebo|Substudy 1: Double-blind Risankizumab Dose 1","\n\n * Subjects who have completed Study M16-065 or Study M16-067 and have achieved clinical response\n\n","\n\n * Subjects who have a known hypersensitivity to risankizumab or the excipients of any of the study drugs or the ingredients of chinese hamster ovary (CHO) or had an adverse event (AE) during Studies M16-065 or M16-067 that in the Investigator's judgment makes the subject unsuitable for this study\n * Subject is considered by the Investigator, for any reason, to be an unsuitable candidate for the study\n * Subject is not in compliance with prior and concomitant medication requirements throughout Studies M16-065 and M16-067",{"$nulls":4},"Actual","2018-01-12","Actual","Anticipated","2024-06-30","Anticipated","2019-06-01","2018-01-08","2018-01-08","2019-06-14","Yes","ABBV-066\nBI 655066","Interventional","Treatment","Parallel Assignment","Triple (Participant, Investigator, Outcomes Assessor)","Randomized","16 Years","80 Years","All",null,"No","Yes\nAbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2016-004676-22","EudraCT Number","Percentage of participants with clinical remission per adapted Mayo Score at Week 52","Clinical remission per Adapted Mayo Score.","Week 52","Percentage of participants with clinical remission per adapted Mayo Score at Week 52 in subjects with a clinical remission at Week 0|Percentage of participants who discontinued corticosteroid use at Week 52 in subjects who were taking steroids at Baseline (of induction)|Percentage of participants who discontinued corticosteroid use, remained corticosteroid free for 90 days, and achieved clinical remission per adapted Mayo Score at Week 52 in subjects taking steroids at Baseline (of induction).|Percentage of participants with endoscopic remission at Week 52|Ulcerative Colitis Symptom Questionnaire (UC-SQ): Change from Week 0 to Week 52|Percentage of participants with Ulcerative Colitis (UC)-related surgeries through Week 52|Percentage of participants with hospitalization through Week 52|36-Item Short Form Health Status Survey (SF-36): Change from Week 0 to Week 52|Inflammatory Bowel Disease Questionnaire (IBDQ): Change from Week 0 to Week 52|Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue): Change from Week 0 to Week 52|Percentage of participants with endoscopic improvement at Week 52|Percentage of participants with clinical remission per full Mayo Score at Week 52 in subjects with a full Mayo Score of 6 to 12 at Baseline (of Induction)|Percentage of participants with endoscopic improvement at Week 52 in participants with endoscopic improvement at Week 0|Percentage of participants with clinical response per adapted Mayo score at Week 52|Percentage of participants with histologic remission at Week 52|Percentage of participants with mucosal healing at Week 52","Clinical remission per Adapted Mayo Score.|Participants who discontinued corticosteroid use.|Endoscopic remission per endoscopy subscore.|The UC-SQ is a patient questionnaire to assess severity of ulcerative colitis symptoms.|Participants who underwent surgery related to UC.|Participants with an event that results in admission to the hospital.|The SF-36 is an indicator of overall health status.|The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.|The FACIT-Fatigue is a validated tool that measures an individual's level of fatigue during their usual daily activities over the past week.|Endoscopic improvement per endoscopy subscore.|Clinical remission per full Mayo Score.|Clinical response per Adapted Mayo score.|Histologic remission per Geboes Score.|Mucosal healing defined as endoscopic and histologic remission.","Week 52|Week 0, Week 52|52 weeks","abbvieclinicaltrials@abbvie.com","ABBVIE CALL CENTER","847.283.8955",{"$cut":{"chars":22485,"head":"Buenos Aires, Argentina, 1431 Instituto Medico Cer /Id# 168685Quilmes, Argentina, 1878 Sanatorio 9 De Julio S.A. /Id# 167803San Miguel De Tucuman, Argentina, 4000|Rosario, Santa Fe, Argentina, 2000|Graz, Austria, 8036 Lkh Salzburg And Paracelsus /Id# 200686Salzburg, Austria, 5020|St. PÃ¶lten, Niederoesterreich, Austria, 3100|Vienna, Wien, Austria, 1090|Brussels, Bruxelles-Capitale, Belgium, 1070 Cliniques Universitaires Saint Luc /Id# 200260Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200|Bonheiden, Belgium, 2820 Uz Brussels /Id# 164175Jette, Brussels, Belgium, 1090 Uz Leuven /Id# 170829Leuven, Belgium, 3000 Clinique St Joseph /Id# 200255Liege, Belgium, 4000 Az-Delta /Id# 200258Roeselare, Belgium, 8800 Chu Dinant Godinne - Ucl Namur /Id# 200259Yvoir, Belgium, 5530|Liege, Liege, Belgium, 4000|Gent, Oost-Vlaanderen, Belgium, 9000|Goiania, Goias, Brazil, 74535-170|Rio De Janeiro, Brazil, 21941-913|Curitiba, Parana, Brazil, 80810-040|Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903|Botucatu, Sao Paulo, Brazil, 18618-686 Hospital Das Clinicas Da Faculdade De Medicina De RibeirÃ£o Preto - Usp /Id# 157668RibeirÃ£o Preto, Sao Paulo, Brazil, 14048-900 Faculdade De Medicina Do Abc /Id# 163993Santo AndrÃ©, Sao Paulo, Brazil, 09060-870 Kaiser Clinica E Hospital Dia /Id# 157686Sao Jose Do Rio Preto, Sao Paulo, Brazil, 15015-110|Sliven, Bulgaria, 8800 Ii Mhat - Sofia /Id# 200794Sofia, Bulgaria, 1202 Umhat Tsaritsa Joanna - Isul /Id# 209978Sofia, Bulgaria, 1527 Umhat Sv. 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["5ecbf40fe2561b1b11905d35","NCT03398135","2019-07-05","AbbVie","ABBV","Recruiting","A Study to Assess the Efficacy and Safety of Risankizumab in Subjects With Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065","Risankizumab","IL23 Inhibitor","No",null,"No",null,"Phase 3",6,760,"Anticipated","2018-08-28","2022-12-04",{"$nulls":5},"The purpose of this study is to evaluate safety and efficacy of risankizumab in subjects with ulcerative colitis (UC) in subjects who responded to induction treatment with risankizumab in a prior AbbVie study of risankizumab in UC.\n\nThis study consists of three sub-studies: Substudy 1 is a 52-week, randomized, double-blind, placebo-controlled maintenance study; Substudy 2 is 52-week, randomized, exploratory maintenance study; and Substudy 3 is an open-label long-term extension study for subjects who completed Substudy 1 or 2.",null,"A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects With Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065","M16-066","Ulcerative Colitis (UC)","Colitis|Colitis, Ulcerative","Gastrointestinal Diseases","Gastrointestinal","Experimental|Placebo Comparator","Substudy 2: Open-label Risankizumab Dose 1|Substudy 1: Double-blind Risankizumab Dose 2|Substudy 2: Open-label Risankizumab Dose 2|Substudy 3: Open-label Extension Risankizumab|Substudy 1: Double-blind Placebo|Substudy 1: Double-blind Risankizumab Dose 1","Participants randomized to receive risankizumab dose 1 administered by subcutaneous (SC) injection.|Participants randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection.|Participants who completed Sub-study 1 or 2 receive open-label risankizumab in Sub-study 3.|Participants randomized to receive placebo for risankizumab administered by subcutaneous (SC) injection.","Drug","risankizumab|placebo for risankizumab","subcutaneous (SC) injection","ABBV-066 | BI 655066","Substudy 2: Open-label Risankizumab Dose 1|Substudy 1: Double-blind Risankizumab Dose 2|Substudy 2: Open-label Risankizumab Dose 2|Substudy 3: Open-label Extension Risankizumab|Substudy 1: Double-blind Placebo|Substudy 1: Double-blind Risankizumab Dose 1","\n\n- Subjects who have completed Study M16-065 or Study M16-067 and have achieved clinical response\n\n","\n\n * Subjects who have a known hypersensitivity to risankizumab or the excipients of any of the study drugs or the ingredients of chinese hamster ovary (CHO) or had an adverse event (AE) during Studies M16-065 or M16-067 that in the Investigator's judgment makes the subject unsuitable for this study\n * Subject is considered by the Investigator, for any reason, to be an unsuitable candidate for the study\n * Subject is not in compliance with prior and concomitant medication requirements throughout Studies M16-065 and M16-067",{"$nulls":4},"Actual","2018-01-12","Actual","Anticipated","2024-06-30","Anticipated","2019-07-01","2018-01-08","2018-01-08","2019-07-03","Yes","ABBV-066\nBI 655066","Interventional","Treatment","Parallel Assignment","Triple (Participant, Investigator, Outcomes Assessor)","Randomized","16 Years","80 Years","All",null,"No","Yes\nAbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2016-004676-22","EudraCT Number","Percentage of participants with clinical remission per adapted Mayo Score at Week 52","Clinical remission per Adapted Mayo Score.","Week 52","Percentage of participants with clinical remission per adapted Mayo Score at Week 52 in subjects with a clinical remission at Week 0|Percentage of participants who discontinued corticosteroid use at Week 52 in subjects who were taking steroids at Baseline (of induction)|Percentage of participants who discontinued corticosteroid use, remained corticosteroid free for 90 days, and achieved clinical remission per adapted Mayo Score at Week 52 in subjects taking steroids at Baseline (of induction).|Percentage of participants with endoscopic remission at Week 52|Ulcerative Colitis Symptom Questionnaire (UC-SQ): Change from Week 0 to Week 52|Percentage of participants with Ulcerative Colitis (UC)-related surgeries through Week 52|Percentage of participants with hospitalization through Week 52|36-Item Short Form Health Status Survey (SF-36): Change from Week 0 to Week 52|Inflammatory Bowel Disease Questionnaire (IBDQ): Change from Week 0 to Week 52|Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue): Change from Week 0 to Week 52|Percentage of participants with endoscopic improvement at Week 52|Percentage of participants with clinical remission per full Mayo Score at Week 52 in subjects with a full Mayo Score of 6 to 12 at Baseline (of Induction)|Percentage of participants with endoscopic improvement at Week 52 in participants with endoscopic improvement at Week 0|Percentage of participants with clinical response per adapted Mayo score at Week 52|Percentage of participants with histologic remission at Week 52|Percentage of participants with mucosal healing at Week 52","Clinical remission per Adapted Mayo Score.|Participants who discontinued corticosteroid use.|Endoscopic remission per endoscopy subscore.|The UC-SQ is a patient questionnaire to assess severity of ulcerative colitis symptoms.|Participants who underwent surgery related to UC.|Participants with an event that results in admission to the hospital.|The SF-36 is an indicator of overall health status.|The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.|The FACIT-Fatigue is a validated tool that measures an individual's level of fatigue during their usual daily activities over the past week.|Endoscopic improvement per endoscopy subscore.|Clinical remission per full Mayo Score.|Clinical response per Adapted Mayo score.|Histologic remission per Geboes Score.|Mucosal healing defined as endoscopic and histologic remission.","Week 52|Week 0, Week 52|52 weeks","abbvieclinicaltrials@abbvie.com","ABBVIE CALL CENTER","847.283.8955",{"$cut":{"chars":22550,"head":"Buenos Aires, Argentina, 1431 Instituto Medico Cer /Id# 168685Quilmes, Argentina, 1878 Sanatorio 9 De Julio S.A. /Id# 167803San Miguel De Tucuman, Argentina, 4000|Rosario, Santa Fe, Argentina, 2000|Graz, Austria, 8036 Lkh Salzburg And Paracelsus /Id# 200686Salzburg, Austria, 5020|St. PÃ¶lten, Niederoesterreich, Austria, 3100|Vienna, Wien, Austria, 1090|Brussels, Bruxelles-Capitale, Belgium, 1070 Cliniques Universitaires Saint Luc /Id# 200260Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200|Bonheiden, Belgium, 2820 Uz Brussels /Id# 164175Jette, Brussels, Belgium, 1090 Uz Leuven /Id# 170829Leuven, Belgium, 3000 Clinique St Joseph /Id# 200255Liege, Belgium, 4000 Az-Delta /Id# 200258Roeselare, Belgium, 8800 Chu Dinant Godinne - Ucl Namur /Id# 200259Yvoir, Belgium, 5530|Liege, Liege, Belgium, 4000|Gent, Oost-Vlaanderen, Belgium, 9000|Goiania, Goias, Brazil, 74535-170|Rio De Janeiro, Brazil, 21941-913|Curitiba, Parana, Brazil, 80810-040|Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903|Botucatu, Sao Paulo, Brazil, 18618-686 Hospital Das Clinicas Da Faculdade De Medicina De RibeirÃ£o Preto - Usp /Id# 157668RibeirÃ£o Preto, Sao Paulo, Brazil, 14048-900 Faculdade De Medicina Do Abc /Id# 163993Santo AndrÃ©, Sao Paulo, Brazil, 09060-870 Kaiser Clinica E Hospital Dia /Id# 157686Sao Jose Do Rio Preto, Sao Paulo, Brazil, 15015-110|Sliven, Bulgaria, 8800 Ii Mhat - Sofia /Id# 200794Sofia, Bulgaria, 1202 Umhat Tsaritsa Joanna - Isul /Id# 209978Sofia, Bulgaria, 1527 Umhat Sv. 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["5ecbf410307e3d1b1f8d9ccb","NCT03398135","2019-08-05","AbbVie","ABBV","Recruiting","A Study to Assess the Efficacy and Safety of Risankizumab in Subjects With Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065","Risankizumab","IL23 Inhibitor","No",null,"No",null,"Phase 3",6,760,"Anticipated","2018-08-28","2022-12-04",{"$nulls":5},"The purpose of this study is to evaluate safety and efficacy of risankizumab in subjects with ulcerative colitis (UC) in subjects who responded to induction treatment with risankizumab in a prior AbbVie study of risankizumab in UC.\n\nThis study consists of three sub-studies: Substudy 1 is a 52-week, randomized, double-blind, placebo-controlled maintenance study; Substudy 2 is 52-week, randomized, exploratory maintenance study; and Substudy 3 is an open-label long-term extension study for subjects who completed Substudy 1 or 2.",null,"A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects With Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065","M16-066","Ulcerative Colitis (UC)","Colitis|Colitis, Ulcerative","Gastrointestinal Diseases","Gastrointestinal","Experimental|Placebo Comparator","Substudy 2: Open-label Risankizumab Dose 1|Substudy 1: Double-blind Risankizumab Dose 2|Substudy 2: Open-label Risankizumab Dose 2|Substudy 3: Open-label Extension Risankizumab|Substudy 1: Double-blind Placebo|Substudy 1: Double-blind Risankizumab Dose 1","Participants randomized to receive risankizumab dose 1 administered by subcutaneous (SC) injection.|Participants randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection.|Participants who completed Sub-study 1 or 2 receive open-label risankizumab in Sub-study 3.|Participants randomized to receive placebo for risankizumab administered by subcutaneous (SC) injection.","Drug","risankizumab|placebo for risankizumab","subcutaneous (SC) injection","ABBV-066 | BI 655066","Substudy 2: Open-label Risankizumab Dose 1|Substudy 1: Double-blind Risankizumab Dose 2|Substudy 2: Open-label Risankizumab Dose 2|Substudy 3: Open-label Extension Risankizumab|Substudy 1: Double-blind Placebo|Substudy 1: Double-blind Risankizumab Dose 1","\n\n * Subjects who have completed Study M16-065 or Study M16-067 and have achieved clinical response\n\n","\n\n * Subjects who have a known hypersensitivity to risankizumab or the excipients of any of the study drugs or the ingredients of chinese hamster ovary (CHO) or had an adverse event (AE) during Studies M16-065 or M16-067 that in the Investigator's judgment makes the subject unsuitable for this study\n * Subject is considered by the Investigator, for any reason, to be an unsuitable candidate for the study\n * Subject is not in compliance with prior and concomitant medication requirements throughout Studies M16-065 and M16-067",{"$nulls":4},"Actual","2018-01-12","Actual","Anticipated","2024-06-30","Anticipated","2019-08-01","2018-01-08","2018-01-08","2019-08-01","Yes","ABBV-066\nBI 655066","Interventional","Treatment","Parallel Assignment","Triple (Participant, Investigator, Outcomes Assessor)","Randomized","16 Years","80 Years","All",null,"No","Yes\nAbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2016-004676-22","EudraCT Number","Percentage of participants with clinical remission per adapted Mayo Score at Week 52","Clinical remission per Adapted Mayo Score.","Week 52","Percentage of participants with clinical remission per adapted Mayo Score at Week 52 in subjects with a clinical remission at Week 0|Percentage of participants who discontinued corticosteroid use at Week 52 in subjects who were taking steroids at Baseline (of induction)|Percentage of participants who discontinued corticosteroid use, remained corticosteroid free for 90 days, and achieved clinical remission per adapted Mayo Score at Week 52 in subjects taking steroids at Baseline (of induction).|Percentage of participants with endoscopic remission at Week 52|Ulcerative Colitis Symptom Questionnaire (UC-SQ): Change from Week 0 to Week 52|Percentage of participants with Ulcerative Colitis (UC)-related surgeries through Week 52|Percentage of participants with hospitalization through Week 52|36-Item Short Form Health Status Survey (SF-36): Change from Week 0 to Week 52|Inflammatory Bowel Disease Questionnaire (IBDQ): Change from Week 0 to Week 52|Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue): Change from Week 0 to Week 52|Percentage of participants with endoscopic improvement at Week 52|Percentage of participants with clinical remission per full Mayo Score at Week 52 in subjects with a full Mayo Score of 6 to 12 at Baseline (of Induction)|Percentage of participants with endoscopic improvement at Week 52 in participants with endoscopic improvement at Week 0|Percentage of participants with clinical response per adapted Mayo score at Week 52|Percentage of participants with histologic remission at Week 52|Percentage of participants with mucosal healing at Week 52","Clinical remission per Adapted Mayo Score.|Participants who discontinued corticosteroid use.|Endoscopic remission per endoscopy subscore.|The UC-SQ is a patient questionnaire to assess severity of ulcerative colitis symptoms.|Participants who underwent surgery related to UC.|Participants with an event that results in admission to the hospital.|The SF-36 is an indicator of overall health status.|The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.|The FACIT-Fatigue is a validated tool that measures an individual's level of fatigue during their usual daily activities over the past week.|Endoscopic improvement per endoscopy subscore.|Clinical remission per full Mayo Score.|Clinical response per Adapted Mayo score.|Histologic remission per Geboes Score.|Mucosal healing defined as endoscopic and histologic remission.","Week 52|Week 0, Week 52|52 weeks","abbvieclinicaltrials@abbvie.com","ABBVIE CALL CENTER","847.283.8955",{"$cut":{"chars":22571,"head":"Buenos Aires, Argentina, 1431 Instituto Medico Cer /Id# 168685Quilmes, Argentina, 1878 Sanatorio 9 De Julio S.A. /Id# 167803San Miguel De Tucuman, Argentina, 4000|Rosario, Santa Fe, Argentina, 2000|Graz, Austria, 8036 Lkh Salzburg And Paracelsus /Id# 200686Salzburg, Austria, 5020|St. PÃ¶lten, Niederoesterreich, Austria, 3100|Vienna, Wien, Austria, 1090|Brussels, Bruxelles-Capitale, Belgium, 1070 Cliniques Universitaires Saint Luc /Id# 200260Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200|Bonheiden, Belgium, 2820 Uz Brussels /Id# 164175Jette, Brussels, Belgium, 1090 Uz Leuven /Id# 170829Leuven, Belgium, 3000 Clinique St Joseph /Id# 200255Liege, Belgium, 4000 Az-Delta /Id# 200258Roeselare, Belgium, 8800 Chu Dinant Godinne - Ucl Namur /Id# 200259Yvoir, Belgium, 5530|Liege, Liege, Belgium, 4000|Gent, Oost-Vlaanderen, Belgium, 9000|Goiania, Goias, Brazil, 74535-170|Rio De Janeiro, Brazil, 21941-913|Curitiba, Parana, Brazil, 80810-040|Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903|Botucatu, Sao Paulo, Brazil, 18618-686 Hospital Das Clinicas Da Faculdade De Medicina De RibeirÃ£o Preto - Usp /Id# 157668RibeirÃ£o Preto, Sao Paulo, Brazil, 14048-900 Faculdade De Medicina Do Abc /Id# 163993Santo AndrÃ©, Sao Paulo, Brazil, 09060-870 Kaiser Clinica E Hospital Dia /Id# 157686Sao Jose Do Rio Preto, Sao Paulo, Brazil, 15015-110|Sliven, Bulgaria, 8800 Ii Mhat - Sofia /Id# 200794Sofia, Bulgaria, 1202 Umhat Tsaritsa Joanna - Isul /Id# 209978Sofia, Bulgaria, 1527 Umhat Sv. 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Rooseve /Id# 164348|Univ Medical Ctr Ljubljana /Id# 210628|, Free State Farmovs (Pty) Ltd /Id# 207538|, Gauteng Wits Clinical Research Site /Id# 171140|, Western Cape Allergy & Immunology (Aiu) /Id# 171439|Dr Jp Wright /Id# 171142|Hospital Universitario Parc Tauli /Id# 159473|Pontevedra Hospital Alvaro Cunqueiro /Id# 167359|Su Molndal. /Id# 202841|Vastra Gotalands Lan AlingsÃ¥s Lasarett /Id# 202075|University Hospital Zurich /Id# 202908|Ankara Univ Medical Faculty /Id# 167205|Istanbul Acibadem Kozyatagi Hospital /Id# 213277|Kayseri Erciyes University Medical Fac /Id# 171283|Kyivska Oblast Medical Centre Of Ok!Clinic Of International Institute Of Clinical Trials /Id# 205484|Regional Clinical Hospital /Id# 203366|, Devon Rd&E Hospital /Id# 157614|Barnsley Hospital Nhs Foundation Trust /Id# 202771|Ucsd /Id# 160430|Peak Gastroenterology Associat /Id# 165838|Medical Research Ctr Ct /Id# 160287|South Lake Pain Institute, Inc /Id# 162859|Emory University Hospital /Id# 160570|University Of Chicago /Id# 160511|Indiana University /Id# 167250|Cotton-O'Neil Clinical Res Ctr /Id# 160367|Houma Digestive Health Special /Id# 158377|Mgh Digestive Health Center /Id# 164257|University Of Michigan Hospitals /Id# 159430|Mayo Clinic - Rochester /Id# 200455|Quality Clinical Research Inc. /Id# 167312|Revival Research Institute, Llc /Id# 210988|Concorde Medical Group Pllc /Id# 211803|Carolinas Medical Center /Id# 158543|Plains Clinical Research Center, Llc /Id# 169729|Cleveland Clinic Main Campus /Id# 209235|Digestive Disease Specialists /Id# 170777|University Of Pennsylvania /Id# 166262|Gastroenterology Associates, P.A. /Id# 160457|Gastro One /Id# 160373|Inquest Clinical Research /Id# 165686|Advanced Research Institute /Id# 160465|Pediatric Specialty Of Va /Id# 166819|Virginia Mason Medical Center /Id# 160432",{"$nulls":3},"AbbVie Inc.","2019-08-01","2020-05-25T16:36:32.490","2020-05-26T17:10:42.972","NCT03398135"]
["5ecbf41011702c1b1b916a4b","NCT03398135","2019-08-28","AbbVie","ABBV","Recruiting","A Study to Assess the Efficacy and Safety of Risankizumab in Subjects With Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065","Risankizumab","IL23 Inhibitor","No",null,"No",null,"Phase 3",6,760,"Anticipated","2018-08-28","2022-12-04",{"$nulls":5},"The purpose of this study is to evaluate safety and efficacy of risankizumab in subjects with ulcerative colitis (UC) in subjects who responded to induction treatment with risankizumab in a prior AbbVie study of risankizumab in UC.\n\nThis study consists of three sub-studies: Substudy 1 is a 52-week, randomized, double-blind, placebo-controlled maintenance study; Substudy 2 is 52-week, randomized, exploratory maintenance study; and Substudy 3 is an open-label long-term extension study for subjects who completed Substudy 1 or 2.",null,"A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects With Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065","M16-066","Ulcerative Colitis (UC)","Colitis|Colitis, Ulcerative","Gastrointestinal Diseases","Gastrointestinal","Experimental|Placebo Comparator","Substudy 2: Open-label Risankizumab Dose 1|Substudy 1: Double-blind Risankizumab Dose 2|Substudy 2: Open-label Risankizumab Dose 2|Substudy 3: Open-label Extension Risankizumab|Substudy 1: Double-blind Placebo|Substudy 1: Double-blind Risankizumab Dose 1","Participants randomized to receive risankizumab dose 1 administered by subcutaneous (SC) injection.|Participants randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection.|Participants who completed Sub-study 1 or 2 receive open-label risankizumab in Sub-study 3.|Participants randomized to receive placebo for risankizumab administered by subcutaneous (SC) injection.","Drug","risankizumab|placebo for risankizumab","subcutaneous (SC) injection","ABBV-066 | BI 655066","Substudy 2: Open-label Risankizumab Dose 1|Substudy 1: Double-blind Risankizumab Dose 2|Substudy 2: Open-label Risankizumab Dose 2|Substudy 3: Open-label Extension Risankizumab|Substudy 1: Double-blind Placebo|Substudy 1: Double-blind Risankizumab Dose 1","\n\n * Subjects who have completed Study M16-065 or Study M16-067 and have achieved clinical response\n\n","\n\n * Subjects who have a known hypersensitivity to risankizumab or the excipients of any of the study drugs or the ingredients of chinese hamster ovary (CHO) or had an adverse event (AE) during Studies M16-065 or M16-067 that in the Investigator's judgment makes the subject unsuitable for this study\n * Subject is considered by the Investigator, for any reason, to be an unsuitable candidate for the study\n * Subject is not in compliance with prior and concomitant medication requirements throughout Studies M16-065 and M16-067",{"$nulls":4},"Actual","2018-01-12","Actual","Anticipated","2024-06-30","Anticipated","2019-08-01","2018-01-08","2018-01-08","2019-08-23","Yes","ABBV-066\nBI 655066","Interventional","Treatment","Parallel Assignment","Triple (Participant, Investigator, Outcomes Assessor)","Randomized","16 Years","80 Years","All",null,"No","Yes\nAbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2016-004676-22","EudraCT Number","Percentage of participants with clinical remission per adapted Mayo Score at Week 52","Clinical remission per Adapted Mayo Score.","Week 52","Percentage of participants with clinical remission per adapted Mayo Score at Week 52 in subjects with a clinical remission at Week 0|Percentage of participants who discontinued corticosteroid use at Week 52 in subjects who were taking steroids at Baseline (of induction)|Percentage of participants who discontinued corticosteroid use, remained corticosteroid free for 90 days, and achieved clinical remission per adapted Mayo Score at Week 52 in subjects taking steroids at Baseline (of induction).|Percentage of participants with endoscopic remission at Week 52|Ulcerative Colitis Symptom Questionnaire (UC-SQ): Change from Week 0 to Week 52|Percentage of participants with Ulcerative Colitis (UC)-related surgeries through Week 52|Percentage of participants with hospitalization through Week 52|36-Item Short Form Health Status Survey (SF-36): Change from Week 0 to Week 52|Inflammatory Bowel Disease Questionnaire (IBDQ): Change from Week 0 to Week 52|Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue): Change from Week 0 to Week 52|Percentage of participants with endoscopic improvement at Week 52|Percentage of participants with clinical remission per full Mayo Score at Week 52 in subjects with a full Mayo Score of 6 to 12 at Baseline (of Induction)|Percentage of participants with endoscopic improvement at Week 52 in participants with endoscopic improvement at Week 0|Percentage of participants with clinical response per adapted Mayo score at Week 52|Percentage of participants with histologic remission at Week 52|Percentage of participants with mucosal healing at Week 52","Clinical remission per Adapted Mayo Score.|Participants who discontinued corticosteroid use.|Endoscopic remission per endoscopy subscore.|The UC-SQ is a patient questionnaire to assess severity of ulcerative colitis symptoms.|Participants who underwent surgery related to UC.|Participants with an event that results in admission to the hospital.|The SF-36 is an indicator of overall health status.|The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.|The FACIT-Fatigue is a validated tool that measures an individual's level of fatigue during their usual daily activities over the past week.|Endoscopic improvement per endoscopy subscore.|Clinical remission per full Mayo Score.|Clinical response per Adapted Mayo score.|Histologic remission per Geboes Score.|Mucosal healing defined as endoscopic and histologic remission.","Week 52|Week 0, Week 52|52 weeks","abbvieclinicaltrials@abbvie.com","ABBVIE CALL CENTER","847.283.8955",{"$cut":{"chars":22480,"head":"Buenos Aires, Argentina, 1431 Instituto Medico Cer /Id# 168685Quilmes, Argentina, 1878 Sanatorio 9 De Julio S.A. /Id# 167803San Miguel De Tucuman, Argentina, 4000|Rosario, Santa Fe, Argentina, 2000|Graz, Austria, 8036 Lkh Salzburg And Paracelsus /Id# 200686Salzburg, Austria, 5020|St. PÃ¶lten, Niederoesterreich, Austria, 3100|Vienna, Wien, Austria, 1090|Brussels, Bruxelles-Capitale, Belgium, 1070 Cliniques Universitaires Saint Luc /Id# 200260Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200|Bonheiden, Belgium, 2820 Uz Brussels /Id# 164175Jette, Brussels, Belgium, 1090 Uz Leuven /Id# 170829Leuven, Belgium, 3000 Clinique St Joseph /Id# 200255Liege, Belgium, 4000 Az-Delta /Id# 200258Roeselare, Belgium, 8800 Chu Dinant Godinne - Ucl Namur /Id# 200259Yvoir, Belgium, 5530|Liege, Liege, Belgium, 4000|Gent, Oost-Vlaanderen, Belgium, 9000|Goiania, Goias, Brazil, 74535-170|Rio De Janeiro, Brazil, 21941-913|Curitiba, Parana, Brazil, 80810-040|Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903|Botucatu, Sao Paulo, Brazil, 18618-686 Hospital Das Clinicas Da Faculdade De Medicina De RibeirÃ£o Preto - Usp /Id# 157668RibeirÃ£o Preto, Sao Paulo, Brazil, 14048-900 Faculdade De Medicina Do Abc /Id# 163993Santo AndrÃ©, Sao Paulo, Brazil, 09060-870 Kaiser Clinica E Hospital Dia /Id# 157686Sao Jose Do Rio Preto, Sao Paulo, Brazil, 15015-110|Sliven, Bulgaria, 8800 Ii Mhat - Sofia /Id# 200794Sofia, Bulgaria, 1202 Umhat Tsaritsa Joanna - Isul /Id# 209978Sofia, Bulgaria, 1527 Umhat Sv. 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Rooseve /Id# 164348|Univ Medical Ctr Ljubljana /Id# 210628|, Free State Farmovs (Pty) Ltd /Id# 207538|, Gauteng Wits Clinical Research Site /Id# 171140|, Western Cape Allergy & Immunology (Aiu) /Id# 171439|Dr Jp Wright /Id# 171142|Hospital Universitario Parc Tauli /Id# 159473|Pontevedra Hospital Alvaro Cunqueiro /Id# 167359|Su Molndal. /Id# 202841|Vastra Gotalands Lan AlingsÃ¥s Lasarett /Id# 202075|University Hospital Zurich /Id# 202908|Ankara Univ Medical Faculty /Id# 167205|Istanbul Acibadem Kozyatagi Hospital /Id# 213277|Kayseri Erciyes University Medical Fac /Id# 171283|Kyivska Oblast Medical Centre Of Ok!Clinic Of International Institute Of Clinical Trials /Id# 205484|Regional Clinical Hospital /Id# 203366|, Devon Rd&E Hospital /Id# 157614|Barnsley Hospital Nhs Foundation Trust /Id# 202771|Ucsd /Id# 160430|Peak Gastroenterology Associat /Id# 165838|Medical Research Ctr Ct /Id# 160287|South Lake Pain Institute, Inc /Id# 162859|Gastro Assoc Of Central Ga /Id# 160513|University Of Chicago /Id# 160511|Indiana University /Id# 167250|Cotton-O'Neil Clinical Res Ctr /Id# 160367|Houma Digestive Health Special /Id# 158377|Mgh Digestive Health Center /Id# 164257|University Of Michigan Hospitals /Id# 159430|Mayo Clinic - Rochester /Id# 200455|Quality Clinical Research Inc. /Id# 167312|Revival Research Institute, Llc /Id# 210988|Concorde Medical Group Pllc /Id# 211803|Carolinas Medical Center /Id# 158543|Plains Clinical Research Center, Llc /Id# 169729|Cleveland Clinic Main Campus /Id# 209235|Digestive Disease Specialists /Id# 170777|University Of Pennsylvania /Id# 166262|Gastroenterology Associates, P.A. /Id# 160457|Gastro One /Id# 160373|Inquest Clinical Research /Id# 165686|Advanced Research Institute /Id# 160465|Pediatric Specialty Of Va /Id# 166819|Virginia Mason Medical Center /Id# 160432",{"$nulls":3},"AbbVie Inc.","2019-08-23","2020-05-25T16:36:32.257","2020-05-26T17:10:42.972","NCT03398135"]
["5ecbf40ffe30261b1a04823a","NCT03398135","2019-09-03","AbbVie","ABBV","Recruiting","A Study to Assess the Efficacy and Safety of Risankizumab in Subjects With Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065","Risankizumab","IL23 Inhibitor","No",null,"No",null,"Phase 3",6,760,"Anticipated","2018-08-28","2022-12-04",{"$nulls":5},"The purpose of this study is to evaluate safety and efficacy of risankizumab in subjects with ulcerative colitis (UC) in subjects who responded to induction treatment with risankizumab in a prior AbbVie study of risankizumab in UC.\n\nThis study consists of three sub-studies: Substudy 1 is a 52-week, randomized, double-blind, placebo-controlled maintenance study; Substudy 2 is 52-week, randomized, exploratory maintenance study; and Substudy 3 is an open-label long-term extension study for subjects who completed Substudy 1 or 2.",null,"A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects With Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065","M16-066","Ulcerative Colitis (UC)","Colitis|Colitis, Ulcerative","Gastrointestinal Diseases","Gastrointestinal","Experimental|Placebo Comparator","Substudy 2: Open-label Risankizumab Dose 1|Substudy 1: Double-blind Risankizumab Dose 2|Substudy 2: Open-label Risankizumab Dose 2|Substudy 3: Open-label Extension Risankizumab|Substudy 1: Double-blind Placebo|Substudy 1: Double-blind Risankizumab Dose 1","Participants randomized to receive risankizumab dose 1 administered by subcutaneous (SC) injection.|Participants randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection.|Participants who completed Sub-study 1 or 2 receive open-label risankizumab in Sub-study 3.|Participants randomized to receive placebo for risankizumab administered by subcutaneous (SC) injection.","Drug","risankizumab|placebo for risankizumab","subcutaneous (SC) injection","ABBV-066 | BI 655066","Substudy 2: Open-label Risankizumab Dose 1|Substudy 1: Double-blind Risankizumab Dose 2|Substudy 2: Open-label Risankizumab Dose 2|Substudy 3: Open-label Extension Risankizumab|Substudy 1: Double-blind Placebo|Substudy 1: Double-blind Risankizumab Dose 1","\n\n * Subjects who have completed Study M16-065 or Study M16-067 and have achieved clinical response\n\n","\n\n * Subjects who have a known hypersensitivity to risankizumab or the excipients of any of the study drugs or the ingredients of chinese hamster ovary (CHO) or had an adverse event (AE) during Studies M16-065 or M16-067 that in the Investigator's judgment makes the subject unsuitable for this study\n * Subject is considered by the Investigator, for any reason, to be an unsuitable candidate for the study\n * Subject is not in compliance with prior and concomitant medication requirements throughout Studies M16-065 and M16-067",{"$nulls":4},"Actual","2018-01-12","Actual","Anticipated","2024-06-30","Anticipated","2019-08-01","2018-01-08","2018-01-08","2019-08-29","Yes","ABBV-066\nBI 655066","Interventional","Treatment","Parallel Assignment","Triple (Participant, Investigator, Outcomes Assessor)","Randomized","16 Years","80 Years","All",null,"No","Yes\nAbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2016-004676-22","EudraCT Number","Percentage of participants with clinical remission per adapted Mayo Score at Week 52","Clinical remission per Adapted Mayo Score.","Week 52","Percentage of participants with clinical remission per adapted Mayo Score at Week 52 in subjects with a clinical remission at Week 0|Percentage of participants who discontinued corticosteroid use at Week 52 in subjects who were taking steroids at Baseline (of induction)|Percentage of participants who discontinued corticosteroid use, remained corticosteroid free for 90 days, and achieved clinical remission per adapted Mayo Score at Week 52 in subjects taking steroids at Baseline (of induction).|Percentage of participants with endoscopic remission at Week 52|Ulcerative Colitis Symptom Questionnaire (UC-SQ): Change from Week 0 to Week 52|Percentage of participants with Ulcerative Colitis (UC)-related surgeries through Week 52|Percentage of participants with hospitalization through Week 52|36-Item Short Form Health Status Survey (SF-36): Change from Week 0 to Week 52|Inflammatory Bowel Disease Questionnaire (IBDQ): Change from Week 0 to Week 52|Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue): Change from Week 0 to Week 52|Percentage of participants with endoscopic improvement at Week 52|Percentage of participants with clinical remission per full Mayo Score at Week 52 in subjects with a full Mayo Score of 6 to 12 at Baseline (of Induction)|Percentage of participants with endoscopic improvement at Week 52 in participants with endoscopic improvement at Week 0|Percentage of participants with clinical response per adapted Mayo score at Week 52|Percentage of participants with histologic remission at Week 52|Percentage of participants with mucosal healing at Week 52","Clinical remission per Adapted Mayo Score.|Participants who discontinued corticosteroid use.|Endoscopic remission per endoscopy subscore.|The UC-SQ is a patient questionnaire to assess severity of ulcerative colitis symptoms.|Participants who underwent surgery related to UC.|Participants with an event that results in admission to the hospital.|The SF-36 is an indicator of overall health status.|The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.|The FACIT-Fatigue is a validated tool that measures an individual's level of fatigue during their usual daily activities over the past week.|Endoscopic improvement per endoscopy subscore.|Clinical remission per full Mayo Score.|Clinical response per Adapted Mayo score.|Histologic remission per Geboes Score.|Mucosal healing defined as endoscopic and histologic remission.","Week 52|Week 0, Week 52|52 weeks","abbvieclinicaltrials@abbvie.com","ABBVIE CALL CENTER","847.283.8955",{"$cut":{"chars":22512,"head":"Buenos Aires, Argentina, 1431 Instituto Medico Cer /Id# 168685Quilmes, Argentina, 1878 Sanatorio 9 De Julio S.A. /Id# 167803San Miguel De Tucuman, Argentina, 4000|Rosario, Santa Fe, Argentina, 2000|Graz, Austria, 8036 Lkh Salzburg And Paracelsus /Id# 200686Salzburg, Austria, 5020|St. PÃ¶lten, Niederoesterreich, Austria, 3100|Vienna, Wien, Austria, 1090|Brussels, Bruxelles-Capitale, Belgium, 1070 Cliniques Universitaires Saint Luc /Id# 200260Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200|Bonheiden, Belgium, 2820 Uz Brussels /Id# 164175Jette, Brussels, Belgium, 1090 Uz Leuven /Id# 170829Leuven, Belgium, 3000 Clinique St Joseph /Id# 200255Liege, Belgium, 4000 Az-Delta /Id# 200258Roeselare, Belgium, 8800 Chu Dinant Godinne - Ucl Namur /Id# 200259Yvoir, Belgium, 5530|Liege, Liege, Belgium, 4000|Gent, Oost-Vlaanderen, Belgium, 9000|Goiania, Goias, Brazil, 74535-170|Rio De Janeiro, Brazil, 21941-913|Curitiba, Parana, Brazil, 80810-040|Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903|Botucatu, Sao Paulo, Brazil, 18618-686 Hospital Das Clinicas Da Faculdade De Medicina De RibeirÃ£o Preto - Usp /Id# 157668RibeirÃ£o Preto, Sao Paulo, Brazil, 14048-900 Faculdade De Medicina Do Abc /Id# 163993Santo AndrÃ©, Sao Paulo, Brazil, 09060-870 Kaiser Clinica E Hospital Dia /Id# 157686Sao Jose Do Rio Preto, Sao Paulo, Brazil, 15015-110|Sliven, Bulgaria, 8800 Ii Mhat - Sofia /Id# 200794Sofia, Bulgaria, 1202 Umhat Tsaritsa Joanna - Isul /Id# 209978Sofia, Bulgaria, 1527 Umhat Sv. 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["5ecbf410feab101b1553086b","NCT03398135","2019-09-24","AbbVie","ABBV","Recruiting","A Study to Assess the Efficacy and Safety of Risankizumab in Subjects With Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065","Risankizumab","IL23 Inhibitor","No",null,"No",null,"Phase 3",6,760,"Anticipated","2018-08-28","2022-12-04",{"$nulls":5},"The purpose of this study is to evaluate safety and efficacy of risankizumab in subjects with ulcerative colitis (UC) in subjects who responded to induction treatment with risankizumab in a prior AbbVie study of risankizumab in UC.\n\nThis study consists of three sub-studies: Substudy 1 is a 52-week, randomized, double-blind, placebo-controlled maintenance study; Substudy 2 is 52-week, randomized, exploratory maintenance study; and Substudy 3 is an open-label long-term extension study for subjects who completed Substudy 1 or 2.",null,"A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects With Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065","M16-066","Ulcerative Colitis (UC)","Colitis|Colitis, Ulcerative","Gastrointestinal Diseases","Gastrointestinal","Experimental|Placebo Comparator","Substudy 2: Open-label Risankizumab Dose 1|Substudy 1: Double-blind Risankizumab Dose 2|Substudy 2: Open-label Risankizumab Dose 2|Substudy 3: Open-label Extension Risankizumab|Substudy 1: Double-blind Placebo|Substudy 1: Double-blind Risankizumab Dose 1","Participants randomized to receive risankizumab dose 1 administered by subcutaneous (SC) injection.|Participants randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection.|Participants who completed Sub-study 1 or 2 receive open-label risankizumab in Sub-study 3.|Participants randomized to receive placebo for risankizumab administered by subcutaneous (SC) injection.","Drug","risankizumab|placebo for risankizumab","subcutaneous (SC) injection","ABBV-066 | BI 655066","Substudy 2: Open-label Risankizumab Dose 1|Substudy 1: Double-blind Risankizumab Dose 2|Substudy 2: Open-label Risankizumab Dose 2|Substudy 3: Open-label Extension Risankizumab|Substudy 1: Double-blind Placebo|Substudy 1: Double-blind Risankizumab Dose 1","\n\n * Subjects who have completed Study M16-065 or Study M16-067 and have achieved clinical response\n\n","\n\n * Subjects who have a known hypersensitivity to risankizumab or the excipients of any of the study drugs or the ingredients of chinese hamster ovary (CHO) or had an adverse event (AE) during Studies M16-065 or M16-067 that in the Investigator's judgment makes the subject unsuitable for this study\n * Subject is considered by the Investigator, for any reason, to be an unsuitable candidate for the study\n * Subject is not in compliance with prior and concomitant medication requirements throughout Studies M16-065 and M16-067",{"$nulls":4},"Actual","2018-01-12","Actual","Anticipated","2024-06-30","Anticipated","2019-09-01","2018-01-08","2018-01-08","2019-09-20","Yes","ABBV-066\nBI 655066","Interventional","Treatment","Parallel Assignment","Triple (Participant, Investigator, Outcomes Assessor)","Randomized","16 Years","80 Years","All",null,"No","Yes\nAbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2016-004676-22","EudraCT Number","Percentage of participants with clinical remission per adapted Mayo Score at Week 52","Clinical remission per Adapted Mayo Score.","Week 52","Percentage of participants with clinical remission per adapted Mayo Score at Week 52 in subjects with a clinical remission at Week 0|Percentage of participants who discontinued corticosteroid use at Week 52 in subjects who were taking steroids at Baseline (of induction)|Percentage of participants who discontinued corticosteroid use, remained corticosteroid free for 90 days, and achieved clinical remission per adapted Mayo Score at Week 52 in subjects taking steroids at Baseline (of induction).|Percentage of participants with endoscopic remission at Week 52|Ulcerative Colitis Symptom Questionnaire (UC-SQ): Change from Week 0 to Week 52|Percentage of participants with Ulcerative Colitis (UC)-related surgeries through Week 52|Percentage of participants with hospitalization through Week 52|36-Item Short Form Health Status Survey (SF-36): Change from Week 0 to Week 52|Inflammatory Bowel Disease Questionnaire (IBDQ): Change from Week 0 to Week 52|Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue): Change from Week 0 to Week 52|Percentage of participants with endoscopic improvement at Week 52|Percentage of participants with clinical remission per full Mayo Score at Week 52 in subjects with a full Mayo Score of 6 to 12 at Baseline (of Induction)|Percentage of participants with endoscopic improvement at Week 52 in participants with endoscopic improvement at Week 0|Percentage of participants with clinical response per adapted Mayo score at Week 52|Percentage of participants with histologic remission at Week 52|Percentage of participants with mucosal healing at Week 52","Clinical remission per Adapted Mayo Score.|Participants who discontinued corticosteroid use.|Endoscopic remission per endoscopy subscore.|The UC-SQ is a patient questionnaire to assess severity of ulcerative colitis symptoms.|Participants who underwent surgery related to UC.|Participants with an event that results in admission to the hospital.|The SF-36 is an indicator of overall health status.|The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.|The FACIT-Fatigue is a validated tool that measures an individual's level of fatigue during their usual daily activities over the past week.|Endoscopic improvement per endoscopy subscore.|Clinical remission per full Mayo Score.|Clinical response per Adapted Mayo score.|Histologic remission per Geboes Score.|Mucosal healing defined as endoscopic and histologic remission.","Week 52|Week 0, Week 52|52 weeks","abbvieclinicaltrials@abbvie.com","ABBVIE CALL CENTER","847.283.8955",{"$cut":{"chars":22752,"head":"Buenos Aires, Argentina, 1431 Instituto Medico Cer /Id# 168685Quilmes, Argentina, 1878 Sanatorio 9 De Julio S.A. /Id# 167803San Miguel De Tucuman, Argentina, 4000|Rosario, Santa Fe, Argentina, 2000|Graz, Austria, 8036 Lkh Salzburg And Paracelsus /Id# 200686Salzburg, Austria, 5020|St. PÃ¶lten, Niederoesterreich, Austria, 3100|Vienna, Wien, Austria, 1090|Brussels, Bruxelles-Capitale, Belgium, 1070 Cliniques Universitaires Saint Luc /Id# 200260Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200|Bonheiden, Belgium, 2820 Uz Brussels /Id# 164175Jette, Brussels, Belgium, 1090 Uz Leuven /Id# 170829Leuven, Belgium, 3000 Clinique St Joseph /Id# 200255Liege, Belgium, 4000 Az-Delta /Id# 200258Roeselare, Belgium, 8800 Chu Dinant Godinne - Ucl Namur /Id# 200259Yvoir, Belgium, 5530|Liege, Liege, Belgium, 4000|Gent, Oost-Vlaanderen, Belgium, 9000|Goiania, Goias, Brazil, 74535-170|Rio De Janeiro, Brazil, 21941-913|Curitiba, Parana, Brazil, 80810-040|Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903|Botucatu, Sao Paulo, Brazil, 18618-686 Hospital Das Clinicas Da Faculdade De Medicina De RibeirÃ£o Preto - Usp /Id# 157668RibeirÃ£o Preto, Sao Paulo, Brazil, 14048-900 Faculdade De Medicina Do Abc /Id# 163993Santo AndrÃ©, Sao Paulo, Brazil, 09060-870 Kaiser Clinica E Hospital Dia /Id# 157686Sao Jose Do Rio Preto, Sao Paulo, Brazil, 15015-110|Sliven, Bulgaria, 8800 Ii Mhat - Sofia /Id# 200794Sofia, Bulgaria, 1202 Umhat Tsaritsa Joanna - Isul /Id# 209978Sofia, Bulgaria, 1527 Umhat Sv. 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Ctr. /Id# 169659|Peak Gastroenterology Associat /Id# 165838|Medical Research Ctr Ct /Id# 160287|South Lake Pain Institute, Inc /Id# 162859|Gastro Assoc Of Central Ga /Id# 160513|University Of Chicago /Id# 160511|Indiana University /Id# 167250|Cotton-O'Neil Clinical Res Ctr /Id# 160367|Houma Digestive Health Special /Id# 158377|Mgh Digestive Health Center /Id# 164257|University Of Michigan Hospitals /Id# 159430|Mayo Clinic - Rochester /Id# 200455|Quality Clinical Research Inc. /Id# 167312|Concorde Medical Group Pllc /Id# 211803|Carolinas Medical Center /Id# 158543|Plains Clinical Research Center, Llc /Id# 169729|Cleveland Clinic Main Campus /Id# 209235|Digestive Disease Specialists /Id# 170777|University Of Pennsylvania /Id# 166262|Gastroenterology Associates, P.A. /Id# 160457|Gastro One /Id# 160373|Inquest Clinical Research /Id# 165686|Advanced Research Institute /Id# 160465|Pediatric Specialty Of Va /Id# 166819|Virginia Mason Medical Center /Id# 160432",{"$nulls":3},"AbbVie Inc.","2019-09-20","2020-05-25T16:36:32.514","2020-05-26T17:10:42.972","NCT03398135"]
["5ecbf410e2561b1b11905d36","NCT03398135","2019-10-29","AbbVie","ABBV","Recruiting","A Study to Assess the Efficacy and Safety of Risankizumab in Subjects With Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065","Risankizumab","IL23 Inhibitor","No",null,"No",null,"Phase 3",6,760,"Anticipated","2018-08-28","2022-12-04",{"$nulls":5},"The purpose of this study is to evaluate safety and efficacy of risankizumab in subjects with ulcerative colitis (UC) in subjects who responded to induction treatment with risankizumab in a prior AbbVie study of risankizumab in UC.\n\nThis study consists of three sub-studies: Substudy 1 is a 52-week, randomized, double-blind, placebo-controlled maintenance study; Substudy 2 is 52-week, randomized, exploratory maintenance study; and Substudy 3 is an open-label long-term extension study for subjects who completed Substudy 1 or 2.",null,"A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects With Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065","M16-066","Ulcerative Colitis (UC)","Colitis|Colitis, Ulcerative","Gastrointestinal Diseases","Gastrointestinal","Experimental|Placebo Comparator","Substudy 2: Open-label Risankizumab Dose 1|Substudy 1: Double-blind Risankizumab Dose 2|Substudy 2: Open-label Risankizumab Dose 2|Substudy 3: Open-label Extension Risankizumab|Substudy 1: Double-blind Placebo|Substudy 1: Double-blind Risankizumab Dose 1","Participants randomized to receive risankizumab dose 1 administered by subcutaneous (SC) injection.|Participants randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection.|Participants who completed Sub-study 1 or 2 receive open-label risankizumab in Sub-study 3.|Participants randomized to receive placebo for risankizumab administered by subcutaneous (SC) injection.","Drug","risankizumab|placebo for risankizumab","subcutaneous (SC) injection","ABBV-066 | BI 655066","Substudy 2: Open-label Risankizumab Dose 1|Substudy 1: Double-blind Risankizumab Dose 2|Substudy 2: Open-label Risankizumab Dose 2|Substudy 3: Open-label Extension Risankizumab|Substudy 1: Double-blind Placebo|Substudy 1: Double-blind Risankizumab Dose 1","\n\n- Subjects who have completed Study M16-065 or Study M16-067 and have achieved clinical response\n\n","\n\n * Subjects who have a known hypersensitivity to risankizumab or the excipients of any of the study drugs or the ingredients of chinese hamster ovary (CHO) or had an adverse event (AE) during Studies M16-065 or M16-067 that in the Investigator's judgment makes the subject unsuitable for this study\n * Subject is considered by the Investigator, for any reason, to be an unsuitable candidate for the study\n * Subject is not in compliance with prior and concomitant medication requirements throughout Studies M16-065 and M16-067",{"$nulls":4},"Actual","2018-01-12","Actual","Anticipated","2024-06-30","Anticipated","2019-10-01","2018-01-08","2018-01-08","2019-10-25","Yes","ABBV-066\nBI 655066","Interventional","Treatment","Parallel Assignment","Triple (Participant, Investigator, Outcomes Assessor)","Randomized","16 Years","80 Years","All",null,"No","Yes\nAbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2016-004676-22","EudraCT Number","Percentage of participants with clinical remission per adapted Mayo Score at Week 52","Clinical remission per Adapted Mayo Score.","Week 52","Percentage of participants with clinical remission per adapted Mayo Score at Week 52 in subjects with a clinical remission at Week 0|Percentage of participants who discontinued corticosteroid use at Week 52 in subjects who were taking steroids at Baseline (of induction)|Percentage of participants who discontinued corticosteroid use, remained corticosteroid free for 90 days, and achieved clinical remission per adapted Mayo Score at Week 52 in subjects taking steroids at Baseline (of induction).|Percentage of participants with endoscopic remission at Week 52|Ulcerative Colitis Symptom Questionnaire (UC-SQ): Change from Week 0 to Week 52|Percentage of participants with Ulcerative Colitis (UC)-related surgeries through Week 52|Percentage of participants with hospitalization through Week 52|36-Item Short Form Health Status Survey (SF-36): Change from Week 0 to Week 52|Inflammatory Bowel Disease Questionnaire (IBDQ): Change from Week 0 to Week 52|Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue): Change from Week 0 to Week 52|Percentage of participants with endoscopic improvement at Week 52|Percentage of participants with clinical remission per full Mayo Score at Week 52 in subjects with a full Mayo Score of 6 to 12 at Baseline (of Induction)|Percentage of participants with endoscopic improvement at Week 52 in participants with endoscopic improvement at Week 0|Percentage of participants with clinical response per adapted Mayo score at Week 52|Percentage of participants with histologic remission at Week 52|Percentage of participants with mucosal healing at Week 52","Clinical remission per Adapted Mayo Score.|Participants who discontinued corticosteroid use.|Endoscopic remission per endoscopy subscore.|The UC-SQ is a patient questionnaire to assess severity of ulcerative colitis symptoms.|Participants who underwent surgery related to UC.|Participants with an event that results in admission to the hospital.|The SF-36 is an indicator of overall health status.|The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.|The FACIT-Fatigue is a validated tool that measures an individual's level of fatigue during their usual daily activities over the past week.|Endoscopic improvement per endoscopy subscore.|Clinical remission per full Mayo Score.|Clinical response per Adapted Mayo score.|Histologic remission per Geboes Score.|Mucosal healing defined as endoscopic and histologic remission.","Week 52|Week 0, Week 52|52 weeks","abbvieclinicaltrials@abbvie.com","ABBVIE CALL CENTER","847.283.8955",{"$cut":{"chars":23039,"head":"Buenos Aires, Argentina, 1431 Sanatorio 9 De Julio S.A. /Id# 167803San Miguel De Tucuman, Argentina, 4000|Rosario, Santa Fe, Argentina, 2000|Graz, Austria, 8036 Lkh Salzburg And Paracelsus /Id# 200686Salzburg, Austria, 5020|St. PÃ¶lten, Niederoesterreich, Austria, 3100|Linz, Oberoesterreich, Austria, 4010|Vienna, Wien, Austria, 1090|Brussels, Bruxelles-Capitale, Belgium, 1070 Cliniques Universitaires Saint Luc /Id# 200260Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200|Bonheiden, Belgium, 2820 Uz Brussels /Id# 164175Jette, Brussels, Belgium, 1090 Uz Leuven /Id# 170829Leuven, Belgium, 3000 Clinique St Joseph /Id# 200255Liege, Belgium, 4000 Az-Delta /Id# 200258Roeselare, Belgium, 8800 Chu Dinant Godinne - Ucl Namur /Id# 200259Yvoir, Belgium, 5530|Liege, Liege, Belgium, 4000|Gent, Oost-Vlaanderen, Belgium, 9000|Goiania, Goias, Brazil, 74535-170|Rio De Janeiro, Brazil, 21941-913|Curitiba, Parana, Brazil, 80810-040|Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903|Botucatu, Sao Paulo, Brazil, 18618-686 Hospital Das Clinicas Da Faculdade De Medicina De RibeirÃ£o Preto - Usp /Id# 157668RibeirÃ£o Preto, Sao Paulo, Brazil, 14048-900 Faculdade De Medicina Do Abc /Id# 163993Santo AndrÃ©, Sao Paulo, Brazil, 09060-870 Kaiser Clinica E Hospital Dia /Id# 157686Sao Jose Do Rio Preto, Sao Paulo, Brazil, 15015-110|Sliven, Bulgaria, 8800 Ii Mhat - Sofia /Id# 200794Sofia, Bulgaria, 1202 Umhat Tsaritsa Joanna - Isul /Id# 209978Sofia, Bulgaria, 1527 Umhat Sv. 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Ctr. /Id# 169659|Peak Gastroenterology Associat /Id# 165838|Medical Research Ctr Ct /Id# 160287|South Lake Pain Institute, Inc /Id# 162859|Atlanta Gastro Assoc /Id# 160370|University Of Chicago /Id# 160511|Indiana University /Id# 167250|Cotton-O'Neil Clinical Res Ctr /Id# 160367|Houma Digestive Health Special /Id# 158377|Mgh Digestive Health Center /Id# 164257|University Of Michigan Hospitals /Id# 159430|Mayo Clinic - Rochester /Id# 200455|Quality Clinical Research Inc. /Id# 167312|Concorde Medical Group Pllc /Id# 211803|Carolinas Medical Center /Id# 158543|Plains Clinical Research Center, Llc /Id# 169729|Cleveland Clinic Main Campus /Id# 209235|Digestive Disease Specialists /Id# 170777|University Of Pennsylvania /Id# 166262|Gastroenterology Associates, P.A. /Id# 160457|Gastro One /Id# 160373|Inquest Clinical Research /Id# 165686|Advanced Research Institute /Id# 160465|Pediatric Specialty Of Va /Id# 166819|Virginia Mason Medical Center /Id# 160432",{"$nulls":3},"AbbVie Inc.","2019-10-25","2020-05-25T16:36:32.740","2020-05-26T17:10:42.972","NCT03398135"]
["5ecbf411307e3d1b1f8d9ccc","NCT03398135","2019-11-25","AbbVie","ABBV","Recruiting","A Study to Assess the Efficacy and Safety of Risankizumab in Subjects With Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065","Risankizumab","IL23 Inhibitor","No",null,"No",null,"Phase 3",6,760,"Anticipated","2018-08-28","2022-12-04",{"$nulls":5},"The purpose of this study is to evaluate safety and efficacy of risankizumab in subjects with ulcerative colitis (UC) who responded to induction treatment with risankizumab in a prior AbbVie study of risankizumab in UC.\n\nThis study consists of three sub-studies: Substudy 1 is a 52-week, randomized, double-blind, placebo-controlled maintenance study; Substudy 2 is 52-week, randomized, exploratory maintenance study; and Substudy 3 is an open-label long-term extension study for subjects who completed Substudy 1 or 2.",null,"A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects With Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065","M16-066","Ulcerative Colitis (UC)","Colitis|Colitis, Ulcerative","Gastrointestinal Diseases","Gastrointestinal","Experimental|Placebo Comparator","Substudy 2: Open-label Risankizumab Dose 1|Substudy 1: Double-blind Risankizumab Dose 2|Substudy 2: Open-label Risankizumab Dose 2|Substudy 3: Open-label Extension Risankizumab|Substudy 1: Double-blind Placebo|Substudy 1: Double-blind Risankizumab Dose 1","Participants randomized to receive risankizumab dose 1 administered by subcutaneous (SC) injection.|Participants randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection.|Participants who completed Sub-study 1 or 2 receive open-label risankizumab in Sub-study 3.|Participants randomized to receive placebo for risankizumab administered by subcutaneous (SC) injection.","Drug","risankizumab|placebo for risankizumab","subcutaneous (SC) injection","ABBV-066 | BI 655066","Substudy 2: Open-label Risankizumab Dose 1|Substudy 1: Double-blind Risankizumab Dose 2|Substudy 2: Open-label Risankizumab Dose 2|Substudy 3: Open-label Extension Risankizumab|Substudy 1: Double-blind Placebo|Substudy 1: Double-blind Risankizumab Dose 1","\n\n * Subjects who have completed Study M16-065 or Study M16-067 and have achieved clinical response\n\n","\n\n * Subjects who have a known hypersensitivity to risankizumab or the excipients of any of the study drugs or the ingredients of chinese hamster ovary (CHO) or had an adverse event (AE) during Studies M16-065 or M16-067 that in the Investigator's judgment makes the subject unsuitable for this study\n * Subject is considered by the Investigator, for any reason, to be an unsuitable candidate for the study\n * Subject is not in compliance with prior and concomitant medication requirements throughout Studies M16-065 and M16-067",{"$nulls":4},"Actual","2018-01-12","Actual","Anticipated","2024-06-30","Anticipated","2019-11-01","2018-01-08","2018-01-08","2019-11-22","Yes","ABBV-066\nBI 655066","Interventional","Treatment","Parallel Assignment","Triple (Participant, Investigator, Outcomes Assessor)","Randomized","16 Years","80 Years","All",null,"No","Yes\nAbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2016-004676-22","EudraCT Number","Percentage of participants with clinical remission per adapted Mayo Score at Week 52","Clinical remission per Adapted Mayo Score.","Week 52","Percentage of participants with clinical remission per adapted Mayo Score at Week 52 in subjects with a clinical remission at Week 0|Percentage of participants who discontinued corticosteroid use at Week 52 in subjects who were taking steroids at Baseline (of induction)|Percentage of participants who discontinued corticosteroid use, remained corticosteroid free for 90 days, and achieved clinical remission per adapted Mayo Score at Week 52 in subjects taking steroids at Baseline (of induction).|Percentage of participants with endoscopic remission at Week 52|Ulcerative Colitis Symptom Questionnaire (UC-SQ): Change from Week 0 to Week 52|Percentage of participants with Ulcerative Colitis (UC)-related surgeries through Week 52|Percentage of participants with hospitalization through Week 52|36-Item Short Form Health Status Survey (SF-36): Change from Week 0 to Week 52|Inflammatory Bowel Disease Questionnaire (IBDQ): Change from Week 0 to Week 52|Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue): Change from Week 0 to Week 52|Percentage of participants with endoscopic improvement at Week 52|Percentage of participants with clinical remission per full Mayo Score at Week 52 in subjects with a full Mayo Score of 6 to 12 at Baseline (of Induction)|Percentage of participants with endoscopic improvement at Week 52 in participants with endoscopic improvement at Week 0|Percentage of participants with clinical response per adapted Mayo score at Week 52|Percentage of participants with histologic remission at Week 52|Percentage of participants with mucosal healing at Week 52","Clinical remission per Adapted Mayo Score.|Participants who discontinued corticosteroid use.|Endoscopic remission per endoscopy subscore.|The UC-SQ is a patient questionnaire to assess severity of ulcerative colitis symptoms.|Participants who underwent surgery related to UC.|Participants with an event that results in admission to the hospital.|The SF-36 is an indicator of overall health status.|The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.|The FACIT-Fatigue is a validated tool that measures an individual's level of fatigue during their usual daily activities over the past week.|Endoscopic improvement per endoscopy subscore.|Clinical remission per full Mayo Score.|Clinical response per Adapted Mayo score.|Histologic remission per Geboes Score.|Mucosal healing defined as endoscopic and histologic remission.","Week 52|Week 0, Week 52|52 weeks","abbvieclinicaltrials@abbvie.com","ABBVIE CALL CENTER","847.283.8955",{"$cut":{"chars":23133,"head":"Buenos Aires, Argentina, 1431 Sanatorio 9 De Julio S.A. /Id# 167803San Miguel De Tucuman, Argentina, 4000|Rosario, Santa Fe, Argentina, 2000|Graz, Austria, 8036 Lkh Salzburg And Paracelsus /Id# 200686Salzburg, Austria, 5020|St. PÃ¶lten, Niederoesterreich, Austria, 3100|Linz, Oberoesterreich, Austria, 4010|Vienna, Wien, Austria, 1090|Brussels, Bruxelles-Capitale, Belgium, 1070 Cliniques Universitaires Saint Luc /Id# 200260Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200|Bonheiden, Belgium, 2820 Uz Brussels /Id# 164175Jette, Brussels, Belgium, 1090 Uz Leuven /Id# 170829Leuven, Belgium, 3000 Clinique St Joseph /Id# 200255Liege, Belgium, 4000 Az-Delta /Id# 200258Roeselare, Belgium, 8800 Chu Dinant Godinne - Ucl Namur /Id# 200259Yvoir, Belgium, 5530|Liege, Liege, Belgium, 4000|Gent, Oost-Vlaanderen, Belgium, 9000|Goiania, Goias, Brazil, 74535-170|Rio De Janeiro, Brazil, 21941-913|Curitiba, Parana, Brazil, 80810-040|Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903|Botucatu, Sao Paulo, Brazil, 18618-686 Hospital Das Clinicas Da Faculdade De Medicina De RibeirÃ£o Preto - Usp /Id# 157668RibeirÃ£o Preto, Sao Paulo, Brazil, 14048-900 Faculdade De Medicina Do Abc /Id# 163993Santo AndrÃ©, Sao Paulo, Brazil, 09060-870 Kaiser Clinica E Hospital Dia /Id# 157686Sao Jose Do Rio Preto, Sao Paulo, Brazil, 15015-110|Sliven, Bulgaria, 8800 Ii Mhat - Sofia /Id# 200794Sofia, Bulgaria, 1202 Umhat Tsaritsa Joanna - Isul /Id# 209978Sofia, Bulgaria, 1527 Umhat Sv. 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Rooseve /Id# 164348|Univ Medical Ctr Ljubljana /Id# 210628|, Free State Farmovs (Pty) Ltd /Id# 207538|, Gauteng Wits Clinical Research Site /Id# 171140|, Western Cape Allergy & Immunology (Aiu) /Id# 171439|Dr Jp Wright /Id# 171142|Galicia Complejo Hospitalario Universitario De Ferrol /Id# 159463|Hospital Universitario Parc Tauli /Id# 159473|Pontevedra Hospital Alvaro Cunqueiro /Id# 167359|Su Molndal. /Id# 202841|Vastra Gotalands Lan AlingsÃ¥s Lasarett /Id# 202075|Zuerich University Hospital Zurich /Id# 202908|Ankara Univ Medical Faculty /Id# 167205|Istanbul Acibadem Kozyatagi Hospital /Id# 213277|Kayseri Erciyes University Medical Fac /Id# 171283|Kyivska Oblast Medical Centre Of Ok!Clinic Of International Institute Of Clinical Trials /Id# 205484|Regional Clinical Hospital /Id# 203366|, Devon Rd&E Hospital /Id# 157614|Barnsley Hospital Nhs Foundation Trust /Id# 202771|Southern California Res. Ctr. /Id# 169659|Peak Gastroenterology Associat /Id# 165838|Medical Research Ctr Ct /Id# 160287|South Lake Pain Institute, Inc /Id# 162859|Atlanta Gastro Assoc /Id# 160370|University Of Chicago /Id# 160511|Indiana University /Id# 167250|Cotton-O'Neil Clinical Res Ctr /Id# 160367|Houma Digestive Health Special /Id# 158377|Mgh Digestive Health Center /Id# 164257|University Of Michigan Hospitals /Id# 159430|Mayo Clinic - Rochester /Id# 200455|Quality Clinical Research Inc. /Id# 167312|Concorde Medical Group Pllc /Id# 211803|Carolinas Medical Center /Id# 158543|Plains Clinical Research Center, Llc /Id# 169729|Cleveland Clinic Main Campus /Id# 209235|Digestive Disease Specialists /Id# 170777|University Of Pennsylvania /Id# 166262|Gastroenterology Associates, P.A. /Id# 160457|Gastro One /Id# 160373|Inquest Clinical Research /Id# 165686|Advanced Research Institute /Id# 160465|Pediatric Specialty Of Va /Id# 166819|Virginia Mason Medical Center /Id# 160432",{"$nulls":3},"AbbVie Inc.","2019-11-22","2020-05-25T16:36:33.430","2020-05-26T17:10:42.972","NCT03398135"]
["5ecbf410fe30261b1a04823b","NCT03398135","2019-12-23","AbbVie","ABBV","Recruiting","A Study to Assess the Efficacy and Safety of Risankizumab in Subjects With Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065","Risankizumab","IL23 Inhibitor","No",null,"No",null,"Phase 3",6,760,"Anticipated","2018-08-28","2022-12-04",{"$nulls":5},"The purpose of this study is to evaluate safety and efficacy of risankizumab in subjects with ulcerative colitis (UC) in subjects who responded to induction treatment with risankizumab in a prior AbbVie study of risankizumab in UC.\n\nThis study consists of three sub-studies: Substudy 1 is a 52-week, randomized, double-blind, placebo-controlled maintenance study; Substudy 2 is 52-week, randomized, exploratory maintenance study; and Substudy 3 is an open-label long-term extension study for subjects who completed Substudy 1 or 2.",null,"A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects With Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065","M16-066","Ulcerative Colitis (UC)","Colitis|Colitis, Ulcerative","Gastrointestinal Diseases","Gastrointestinal","Experimental|Placebo Comparator","Substudy 2: Open-label Risankizumab Dose 1|Substudy 1: Double-blind Risankizumab Dose 2|Substudy 2: Open-label Risankizumab Dose 2|Substudy 3: Open-label Extension Risankizumab|Substudy 1: Double-blind Placebo|Substudy 1: Double-blind Risankizumab Dose 1","Participants randomized to receive risankizumab dose 1 administered by subcutaneous (SC) injection.|Participants randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection.|Participants who completed Sub-study 1 or 2 receive open-label risankizumab in Sub-study 3.|Participants randomized to receive placebo for risankizumab administered by subcutaneous (SC) injection.","Drug","risankizumab|placebo for risankizumab","subcutaneous (SC) injection","ABBV-066 | BI 655066","Substudy 2: Open-label Risankizumab Dose 1|Substudy 1: Double-blind Risankizumab Dose 2|Substudy 2: Open-label Risankizumab Dose 2|Substudy 3: Open-label Extension Risankizumab|Substudy 1: Double-blind Placebo|Substudy 1: Double-blind Risankizumab Dose 1","\n\n * Subjects who have completed Study M16-065 or Study M16-067 and have achieved clinical response\n\n","\n\n * Subjects who have a known hypersensitivity to risankizumab or the excipients of any of the study drugs or the ingredients of chinese hamster ovary (CHO) or had an adverse event (AE) during Studies M16-065 or M16-067 that in the Investigator's judgment makes the subject unsuitable for this study\n * Subject is considered by the Investigator, for any reason, to be an unsuitable candidate for the study\n * Subject is not in compliance with prior and concomitant medication requirements throughout Studies M16-065 and M16-067",{"$nulls":4},"Actual","2018-01-12","Actual","Anticipated","2024-06-30","Anticipated","2019-12-01","2018-01-08","2018-01-08","2019-12-19","Yes","ABBV-066\nBI 655066","Interventional","Treatment","Parallel Assignment","Triple (Participant, Investigator, Outcomes Assessor)","Randomized","16 Years","80 Years","All",null,"No","Yes\nAbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2016-004676-22","EudraCT Number","Percentage of participants with clinical remission per adapted Mayo Score at Week 52","Clinical remission per Adapted Mayo Score.","Week 52","Percentage of participants with clinical remission per adapted Mayo Score at Week 52 in subjects with a clinical remission at Week 0|Percentage of participants who discontinued corticosteroid use at Week 52 in subjects who were taking steroids at Baseline (of induction)|Percentage of participants who discontinued corticosteroid use, remained corticosteroid free for 90 days, and achieved clinical remission per adapted Mayo Score at Week 52 in subjects taking steroids at Baseline (of induction).|Percentage of participants with endoscopic remission at Week 52|Ulcerative Colitis Symptom Questionnaire (UC-SQ): Change from Week 0 to Week 52|Percentage of participants with Ulcerative Colitis (UC)-related surgeries through Week 52|Percentage of participants with hospitalization through Week 52|36-Item Short Form Health Status Survey (SF-36): Change from Week 0 to Week 52|Inflammatory Bowel Disease Questionnaire (IBDQ): Change from Week 0 to Week 52|Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue): Change from Week 0 to Week 52|Percentage of participants with endoscopic improvement at Week 52|Percentage of participants with clinical remission per full Mayo Score at Week 52 in subjects with a full Mayo Score of 6 to 12 at Baseline (of Induction)|Percentage of participants with endoscopic improvement at Week 52 in participants with endoscopic improvement at Week 0|Percentage of participants with clinical response per adapted Mayo score at Week 52|Percentage of participants with histologic remission at Week 52|Percentage of participants with mucosal healing at Week 52","Clinical remission per Adapted Mayo Score.|Participants who discontinued corticosteroid use.|Endoscopic remission per endoscopy subscore.|The UC-SQ is a patient questionnaire to assess severity of ulcerative colitis symptoms.|Participants who underwent surgery related to UC.|Participants with an event that results in admission to the hospital.|The SF-36 is an indicator of overall health status.|The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.|The FACIT-Fatigue is a validated tool that measures an individual's level of fatigue during their usual daily activities over the past week.|Endoscopic improvement per endoscopy subscore.|Clinical remission per full Mayo Score.|Clinical response per Adapted Mayo score.|Histologic remission per Geboes Score.|Mucosal healing defined as endoscopic and histologic remission.","Week 52|Week 0, Week 52|52 weeks","abbvieclinicaltrials@abbvie.com","ABBVIE CALL CENTER","847.283.8955",{"$cut":{"chars":23109,"head":"Buenos Aires, Argentina, 1431 Sanatorio 9 De Julio S.A. /Id# 167803San Miguel De Tucuman, Argentina, 4000|Rosario, Santa Fe, Argentina, 2000|Graz, Austria, 8036 Lkh Salzburg And Paracelsus /Id# 200686Salzburg, Austria, 5020|St. PÃ¶lten, Niederoesterreich, Austria, 3100|Linz, Oberoesterreich, Austria, 4010|Vienna, Wien, Austria, 1090|Brussels, Bruxelles-Capitale, Belgium, 1070 Cliniques Universitaires Saint Luc /Id# 200260Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200|Bonheiden, Belgium, 2820 Uz Brussels /Id# 164175Jette, Brussels, Belgium, 1090 Uz Leuven /Id# 170829Leuven, Belgium, 3000 Clinique St Joseph /Id# 200255Liege, Belgium, 4000 Az-Delta /Id# 200258Roeselare, Belgium, 8800 Chu Dinant Godinne - Ucl Namur /Id# 200259Yvoir, Belgium, 5530|Liege, Liege, Belgium, 4000|Gent, Oost-Vlaanderen, Belgium, 9000|Goiania, Goias, Brazil, 74535-170|Rio De Janeiro, Brazil, 21941-913|Curitiba, Parana, Brazil, 80810-040|Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903|Botucatu, Sao Paulo, Brazil, 18618-686 Hospital Das Clinicas Da Faculdade De Medicina De RibeirÃ£o Preto - Usp /Id# 157668RibeirÃ£o Preto, Sao Paulo, Brazil, 14048-900 Faculdade De Medicina Do Abc /Id# 163993Santo AndrÃ©, Sao Paulo, Brazil, 09060-870 Kaiser Clinica E Hospital Dia /Id# 157686Sao Jose Do Rio Preto, Sao Paulo, Brazil, 15015-110|Sliven, Bulgaria, 8800 Ii Mhat - Sofia /Id# 200794Sofia, Bulgaria, 1202 Umhat Tsaritsa Joanna - Isul /Id# 209978Sofia, Bulgaria, 1527 Umhat Sv. 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Ctr. /Id# 169659|Peak Gastroenterology Associat /Id# 165838|Medical Research Ctr Ct /Id# 160287|South Lake Pain Institute, Inc /Id# 162859|Atlanta Gastro Assoc /Id# 160370|University Of Chicago /Id# 160511|Indiana University /Id# 167250|Cotton-O'Neil Clinical Res Ctr /Id# 160367|Houma Digestive Health Special /Id# 158377|Johns Hopkins University School Of Medicine /Id# 211792|Mgh Digestive Health Center /Id# 164257|University Of Michigan Hospitals /Id# 159430|Mayo Clinic - Rochester /Id# 200455|Quality Clinical Research Inc. /Id# 167312|Concorde Medical Group Pllc /Id# 211803|Carolinas Medical Center /Id# 158543|Plains Clinical Research Center, Llc /Id# 169729|Cleveland Clinic Main Campus /Id# 209235|Digestive Disease Specialists /Id# 170777|University Of Pennsylvania /Id# 166262|Gastroenterology Associates, P.A. /Id# 160457|Gastro One /Id# 160373|Inquest Clinical Research /Id# 165686|Advanced Research Institute /Id# 160465|Pediatric Specialty Of Va /Id# 166819|Virginia Mason Medical Center /Id# 160432",{"$nulls":3},"AbbVie Inc.","2019-12-19","2020-05-25T16:36:32.744","2020-05-26T17:10:42.972","NCT03398135"]
["5ecbf411feab101b1553086c","NCT03398135","2020-02-13","AbbVie","ABBV","Recruiting","A Study to Assess the Efficacy and Safety of Risankizumab in Subjects With Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065","Risankizumab","IL23 Inhibitor","No",null,"No",null,"Phase 3",6,760,"Anticipated","2018-08-28","2022-12-04",{"$nulls":5},"The purpose of this study is to evaluate safety and efficacy of risankizumab in subjects with ulcerative colitis (UC) in subjects who responded to induction treatment with risankizumab in a prior AbbVie study of risankizumab in UC.\n\nThis study consists of three sub-studies: Substudy 1 is a 52-week, randomized, double-blind, placebo-controlled maintenance study; Substudy 2 is 52-week, randomized, exploratory maintenance study; and Substudy 3 is an open-label long-term extension study for subjects who completed Substudy 1 or 2.",null,"A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects With Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065","M16-066","Ulcerative Colitis (UC)","Colitis|Colitis, Ulcerative","Gastrointestinal Diseases","Gastrointestinal","Experimental|Placebo Comparator","Substudy 1: Double-blind Risankizumab Dose 1|Substudy 1: Double-blind Placebo|Substudy 3: Open-label Extension Risankizumab|Substudy 2: Open-label Risankizumab Dose 2|Substudy 1: Double-blind Risankizumab Dose 2|Substudy 2: Open-label Risankizumab Dose 1","Participants randomized to receive risankizumab dose 1 administered by subcutaneous (SC) injection.|Participants randomized to receive placebo for risankizumab administered by subcutaneous (SC) injection.|Participants who completed Sub-study 1 or 2 receive open-label risankizumab in Sub-study 3.|Participants randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection.","Drug","risankizumab|placebo for risankizumab","subcutaneous (SC) injection","ABBV-066 | BI 655066","Substudy 1: Double-blind Risankizumab Dose 1|Substudy 1: Double-blind Placebo|Substudy 3: Open-label Extension Risankizumab|Substudy 2: Open-label Risankizumab Dose 2|Substudy 1: Double-blind Risankizumab Dose 2|Substudy 2: Open-label Risankizumab Dose 1","\n\n * Subjects who have completed Study M16-065 or Study M16-067 and have achieved clinical response\n\n","\n\n * Subjects who have a known hypersensitivity to risankizumab or the excipients of any of the study drugs or the ingredients of chinese hamster ovary (CHO) or had an adverse event (AE) during Studies M16-065 or M16-067 that in the Investigator's judgment makes the subject unsuitable for this study\n * Subject is considered by the Investigator, for any reason, to be an unsuitable candidate for the study\n * Subject is not in compliance with prior and concomitant medication requirements throughout Studies M16-065 and M16-067",{"$nulls":4},"Actual","2018-01-12","Actual","Anticipated","2024-06-30","Anticipated","2020-02-01","2018-01-08","2018-01-08","2020-02-12","Yes","ABBV-066\nBI 655066","Interventional","Treatment","Parallel Assignment","Triple (Participant, Investigator, Outcomes Assessor)","Randomized","16 Years","80 Years","All",null,"No","Yes\nAbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2016-004676-22","EudraCT Number","Percentage of participants with clinical remission per adapted Mayo Score at Week 52","Clinical remission per Adapted Mayo Score.","Week 52","Percentage of participants with clinical remission per adapted Mayo Score at Week 52 in subjects with a clinical remission at Week 0|Percentage of participants who discontinued corticosteroid use at Week 52 in subjects who were taking steroids at Baseline (of induction)|Percentage of participants who discontinued corticosteroid use, remained corticosteroid free for 90 days, and achieved clinical remission per adapted Mayo Score at Week 52 in subjects taking steroids at Baseline (of induction).|Percentage of participants with endoscopic remission at Week 52|Ulcerative Colitis Symptom Questionnaire (UC-SQ): Change from Week 0 to Week 52|Percentage of participants with Ulcerative Colitis (UC)-related surgeries through Week 52|Percentage of participants with hospitalization through Week 52|36-Item Short Form Health Status Survey (SF-36): Change from Week 0 to Week 52|Inflammatory Bowel Disease Questionnaire (IBDQ): Change from Week 0 to Week 52|Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue): Change from Week 0 to Week 52|Percentage of participants with endoscopic improvement at Week 52|Percentage of participants with clinical remission per full Mayo Score at Week 52 in subjects with a full Mayo Score of 6 to 12 at Baseline (of Induction)|Percentage of participants with endoscopic improvement at Week 52 in participants with endoscopic improvement at Week 0|Percentage of participants with clinical response per adapted Mayo score at Week 52|Percentage of participants with histologic remission at Week 52|Percentage of participants with mucosal healing at Week 52","Clinical remission per Adapted Mayo Score.|Participants who discontinued corticosteroid use.|Endoscopic remission per endoscopy subscore.|The UC-SQ is a patient questionnaire to assess severity of ulcerative colitis symptoms.|Participants who underwent surgery related to UC.|Participants with an event that results in admission to the hospital.|The SF-36 is an indicator of overall health status.|The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.|The FACIT-Fatigue is a validated tool that measures an individual's level of fatigue during their usual daily activities over the past week.|Endoscopic improvement per endoscopy subscore.|Clinical remission per full Mayo Score.|Clinical response per Adapted Mayo score.|Histologic remission per Geboes Score.|Mucosal healing defined as endoscopic and histologic remission.","Week 52|Week 0, Week 52|52 weeks","abbvieclinicaltrials@abbvie.com","ABBVIE CALL CENTER","847.283.8955",{"$cut":{"chars":23013,"head":"Buenos Aires, Argentina, 1431 Sanatorio 9 De Julio S.A. /Id# 167803San Miguel De Tucuman, Argentina, 4000|Rosario, Santa Fe, Argentina, 2000|Graz, Austria, 8036 Lkh Salzburg And Paracelsus /Id# 200686Salzburg, Austria, 5020|St. PÃ¶lten, Niederoesterreich, Austria, 3100|Linz, Oberoesterreich, Austria, 4010|Vienna, Wien, Austria, 1090|Brussels, Bruxelles-Capitale, Belgium, 1070 Cliniques Universitaires Saint Luc /Id# 200260Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200|Bonheiden, Belgium, 2820 Uz Brussels /Id# 164175Jette, Brussels, Belgium, 1090 Uz Leuven /Id# 170829Leuven, Belgium, 3000 Clinique St Joseph /Id# 200255Liege, Belgium, 4000 Az-Delta /Id# 200258Roeselare, Belgium, 8800 Chu Dinant Godinne - Ucl Namur /Id# 200259Yvoir, Belgium, 5530|Liege, Liege, Belgium, 4000|Gent, Oost-Vlaanderen, Belgium, 9000|Goiania, Goias, Brazil, 74535-170|Rio De Janeiro, Brazil, 21941-913|Curitiba, Parana, Brazil, 80810-040|Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903|Botucatu, Sao Paulo, Brazil, 18618-686 Hospital Das Clinicas Da Faculdade De Medicina De RibeirÃ£o Preto - Usp /Id# 157668RibeirÃ£o Preto, Sao Paulo, Brazil, 14048-900 Faculdade De Medicina Do Abc /Id# 163993Santo AndrÃ©, Sao Paulo, Brazil, 09060-870 Kaiser Clinica E Hospital Dia /Id# 157686Sao Jose Do Rio Preto, Sao Paulo, Brazil, 15015-110|Sliven, Bulgaria, 8800 Ii Mhat - Sofia /Id# 200794Sofia, Bulgaria, 1202 Umhat Tsaritsa Joanna - Isul /Id# 209978Sofia, Bulgaria, 1527 Umhat Sv. 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Ctr. /Id# 169659|Peak Gastroenterology Associat /Id# 165838|Medical Research Ctr Ct /Id# 160287|South Lake Pain Institute, Inc /Id# 162859|Atlanta Gastro Assoc /Id# 160370|University Of Chicago /Id# 160511|Indiana University /Id# 167250|Cotton-O'Neil Clinical Res Ctr /Id# 160367|Houma Digestive Health Special /Id# 158377|Johns Hopkins University School Of Medicine /Id# 211792|Mgh Digestive Health Center /Id# 164257|University Of Michigan Hospitals /Id# 159430|Mayo Clinic - Rochester /Id# 200455|Quality Clinical Research Inc. /Id# 167312|Manhattan Clinical Research, Llc /Id# 211803|Carolinas Medical Center /Id# 158543|Plains Clinical Research Center, Llc /Id# 169729|Cleveland Clinic Main Campus /Id# 209235|Digestive Disease Specialists /Id# 170777|University Of Pennsylvania /Id# 166262|Gastroenterology Associates, P.A. /Id# 160457|Gastro One /Id# 160373|Inquest Clinical Research /Id# 165686|Advanced Research Institute /Id# 160465|Pediatric Specialty Of Va /Id# 166819|Virginia Mason Medical Center /Id# 160432",{"$nulls":3},"AbbVie Inc.","2020-02-12","2020-05-25T16:36:33.437","2020-05-26T17:10:42.972","NCT03398135"]
["5ecbf411e2561b1b11905d37","NCT03398135","2020-03-16","AbbVie","ABBV","Recruiting","A Study to Assess the Efficacy and Safety of Risankizumab in Subjects With Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065","Risankizumab","IL23 Inhibitor","No",null,"No",null,"Phase 3",6,760,"Anticipated","2018-08-28","2022-12-04",{"$nulls":5},"The purpose of this study is to evaluate safety and efficacy of risankizumab in subjects with ulcerative colitis (UC) in subjects who responded to induction treatment with risankizumab in a prior AbbVie study of risankizumab in UC.\n\nThis study consists of three sub-studies: Substudy 1 is a 52-week, randomized, double-blind, placebo-controlled maintenance study; Substudy 2 is 52-week, randomized, exploratory maintenance study; and Substudy 3 is an open-label long-term extension study for subjects who completed Substudy 1 or 2.",null,"A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects With Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065","M16-066","Ulcerative Colitis (UC)","Colitis|Colitis, Ulcerative","Gastrointestinal Diseases","Gastrointestinal","Experimental|Placebo Comparator","Substudy 2: Open-label Risankizumab Dose 1|Substudy 1: Double-blind Risankizumab Dose 2|Substudy 2: Open-label Risankizumab Dose 2|Substudy 3: Open-label Extension Risankizumab|Substudy 1: Double-blind Placebo|Substudy 1: Double-blind Risankizumab Dose 1","Participants randomized to receive risankizumab dose 1 administered by subcutaneous (SC) injection.|Participants randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection.|Participants who completed Sub-study 1 or 2 receive open-label risankizumab in Sub-study 3.|Participants randomized to receive placebo for risankizumab administered by subcutaneous (SC) injection.","Drug","risankizumab|placebo for risankizumab","subcutaneous (SC) injection","ABBV-066 | BI 655066","Substudy 2: Open-label Risankizumab Dose 1|Substudy 1: Double-blind Risankizumab Dose 2|Substudy 2: Open-label Risankizumab Dose 2|Substudy 3: Open-label Extension Risankizumab|Substudy 1: Double-blind Placebo|Substudy 1: Double-blind Risankizumab Dose 1","\n\n * Subjects who have completed Study M16-065 or Study M16-067 and have achieved clinical response\n\n","\n\n * Subjects who have a known hypersensitivity to risankizumab or the excipients of any of the study drugs or the ingredients of chinese hamster ovary (CHO) or had an adverse event (AE) during Studies M16-065 or M16-067 that in the Investigator's judgment makes the subject unsuitable for this study\n * Subject is considered by the Investigator, for any reason, to be an unsuitable candidate for the study\n * Subject is not in compliance with prior and concomitant medication requirements throughout Studies M16-065 and M16-067",{"$nulls":4},"Actual","2018-01-12","Actual","Anticipated","2023-11-07","Anticipated","2020-03-01","2018-01-08","2018-01-08","2020-03-13","Yes","ABBV-066\nBI 655066","Interventional","Treatment","Parallel Assignment","Triple (Participant, Investigator, Outcomes Assessor)","Randomized","16 Years","80 Years","All",null,"No","Yes\nAbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2016-004676-22","EudraCT Number","Percentage of participants with clinical remission per adapted Mayo Score at Week 52","Clinical remission per Adapted Mayo Score.","Week 52","Percentage of participants with clinical remission per adapted Mayo Score at Week 52 in subjects with a clinical remission at Week 0|Percentage of participants who discontinued corticosteroid use at Week 52 in subjects who were taking steroids at Baseline (of induction)|Percentage of participants who discontinued corticosteroid use, remained corticosteroid free for 90 days, and achieved clinical remission per adapted Mayo Score at Week 52 in subjects taking steroids at Baseline (of induction).|Percentage of participants with endoscopic remission at Week 52|Ulcerative Colitis Symptom Questionnaire (UC-SQ): Change from Week 0 to Week 52|Percentage of participants with Ulcerative Colitis (UC)-related surgeries through Week 52|Percentage of participants with hospitalization through Week 52|36-Item Short Form Health Status Survey (SF-36): Change from Week 0 to Week 52|Inflammatory Bowel Disease Questionnaire (IBDQ): Change from Week 0 to Week 52|Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue): Change from Week 0 to Week 52|Percentage of participants with endoscopic improvement at Week 52|Percentage of participants with clinical remission per full Mayo Score at Week 52 in subjects with a full Mayo Score of 6 to 12 at Baseline (of Induction)|Percentage of participants with endoscopic improvement at Week 52 in participants with endoscopic improvement at Week 0|Percentage of participants with clinical response per adapted Mayo score at Week 52|Percentage of participants with histologic remission at Week 52|Percentage of participants with mucosal healing at Week 52","Clinical remission per Adapted Mayo Score.|Participants who discontinued corticosteroid use.|Endoscopic remission per endoscopy subscore.|The UC-SQ is a patient questionnaire to assess severity of ulcerative colitis symptoms.|Participants who underwent surgery related to UC.|Participants with an event that results in admission to the hospital.|The SF-36 is an indicator of overall health status.|The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.|The FACIT-Fatigue is a validated tool that measures an individual's level of fatigue during their usual daily activities over the past week.|Endoscopic improvement per endoscopy subscore.|Clinical remission per full Mayo Score.|Clinical response per Adapted Mayo score.|Histologic remission per Geboes Score.|Mucosal healing defined as endoscopic and histologic remission.","Week 52|Week 0, Week 52|52 weeks","abbvieclinicaltrials@abbvie.com","ABBVIE CALL CENTER","847.283.8955",{"$cut":{"chars":22751,"head":"Buenos Aires, Argentina, 1431 Sanatorio 9 De Julio S.A. /Id# 167803San Miguel De Tucuman, Argentina, 4000|Rosario, Santa Fe, Argentina, 2000|Graz, Austria, 8036 Lkh Salzburg And Paracelsus /Id# 200686Salzburg, Austria, 5020|St. PÃ¶lten, Niederoesterreich, Austria, 3100|Linz, Oberoesterreich, Austria, 4010|Vienna, Wien, Austria, 1090|Brussels, Bruxelles-Capitale, Belgium, 1070 Cliniques Universitaires Saint Luc /Id# 200260Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200|Bonheiden, Belgium, 2820 Uz Brussels /Id# 164175Jette, Brussels, Belgium, 1090 Uz Leuven /Id# 170829Leuven, Belgium, 3000 Chu De Liege /Id# 200257Liege, Belgium, 4000 Clinique St Joseph /Id# 200255Liege, Belgium, 4000 Az-Delta /Id# 200258Roeselare, Belgium, 8800 Chu Dinant Godinne - Ucl Namur /Id# 200259Yvoir, Belgium, 5530|Gent, Oost-Vlaanderen, Belgium, 9000|Goiania, Goias, Brazil, 74535-170|Rio De Janeiro, Brazil, 21941-913|Curitiba, Parana, Brazil, 80810-040|Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903|Botucatu, Sao Paulo, Brazil, 18618-686 Hospital Das Clinicas Da Faculdade De Medicina De RibeirÃ£o Preto - Usp /Id# 157668RibeirÃ£o Preto, Sao Paulo, Brazil, 14048-900 Faculdade De Medicina Do Abc /Id# 163993Santo AndrÃ©, Sao Paulo, Brazil, 09060-870 Kaiser Clinica E Hospital Dia /Id# 157686Sao Jose Do Rio Preto, Sao Paulo, Brazil, 15015-110|Sliven, Bulgaria, 8800 Ii Mhat - Sofia /Id# 200794Sofia, Bulgaria, 1202 Umhat Tsaritsa Joanna - Isul /Id# 209978Sofia, Bulgaria, 1527 Umhat Sv. 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Rooseve /Id# 164348|Univ Medical Ctr Ljubljana /Id# 210628|, Free State Farmovs (Pty) Ltd /Id# 207538|, Gauteng Wits Clinical Research Site /Id# 171140|, Western Cape Allergy & Immunology (Aiu) /Id# 171439|Dr Jp Wright /Id# 171142|Galicia Complejo Hospitalario Universitario De Ferrol /Id# 159463|Hospital Universitario Parc Tauli /Id# 159473|Pontevedra Hospital Alvaro Cunqueiro /Id# 167359|Su Molndal. /Id# 202841|Vastra Gotalands Lan AlingsÃ¥s Lasarett /Id# 202075|Zuerich University Hospital Zurich /Id# 202908|Ankara Univ Medical Faculty /Id# 167205|Istanbul Acibadem Kozyatagi Hospital /Id# 213277|Kayseri Erciyes University Medical Fac /Id# 171283|Kyivska Oblast Medical Centre Ok Clinic Of International Institute Of Clinical Research Llc /Id# 205484|Regional Clinical Hospital /Id# 203366|, Devon Rd&E Hospital /Id# 157614|Barnsley Hospital Nhs Foundation Trust /Id# 202771|Southern California Res. Ctr. /Id# 169659|Peak Gastroenterology Associat /Id# 165838|Medical Research Ctr Ct /Id# 160287|South Lake Pain Institute, Inc /Id# 162859|Gastro Assoc Of Central Ga /Id# 160513|University Of Chicago /Id# 160511|Indiana University /Id# 167250|Cotton-O'Neil Clinical Res Ctr /Id# 160367|Houma Digestive Health Special /Id# 158377|Johns Hopkins University School Of Medicine /Id# 211792|Mgh Digestive Health Center /Id# 164257|University Of Michigan Hospitals /Id# 159430|Mayo Clinic - Rochester /Id# 200455|Quality Clinical Research Inc. /Id# 167312|Manhattan Clinical Research, Llc /Id# 211803|Atrium Health Carolinas Medical Center /Id# 158543|Plains Clinical Research Center, Llc /Id# 169729|Cleveland Clinic Main Campus /Id# 209235|Digestive Disease Specialists /Id# 170777|University Of Pennsylvania /Id# 166262|Gastroenterology Associates, P.A. /Id# 160457|Gastro One /Id# 160373|Inquest Clinical Research /Id# 165686|Advanced Research Institute /Id# 160465|Pediatric Specialty Of Va /Id# 166819|Virginia Mason Medical Center /Id# 160432",{"$nulls":3},"AbbVie Inc.","2020-03-13","2020-05-25T16:36:33.650","2020-05-26T17:10:42.972","NCT03398135"]
["5ecbf41111702c1b1b916a4c","NCT03398135","2020-05-21","AbbVie","ABBV","Recruiting","A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065","Risankizumab","IL23 Inhibitor","No",null,"No",null,"Phase 3",6,760,"Anticipated","2018-08-28","2022-12-04",{"$nulls":5},"The purpose of this study is to evaluate safety and efficacy of risankizumab in participants with ulcerative colitis (UC) in participants who responded to induction treatment with risankizumab in a prior AbbVie study of risankizumab in UC.\n\nThis study consists of three sub-studies: Substudy 1 is a 52-week, randomized, double-blind, placebo-controlled maintenance study; Substudy 2 is 52-week, randomized, exploratory maintenance study; and Substudy 3 is an open-label long-term extension study for participants who completed Substudy 1 or 2, or participants who responded to induction treatment in Study M16-067 with no final endoscopy due to the Covid-19 pandemic.",null,"A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects With Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065","M16-066","Ulcerative Colitis (UC)","Colitis|Colitis, Ulcerative","Gastrointestinal Diseases","Gastrointestinal","Placebo Comparator|Experimental","Substudy 1: Double-blind Placebo|Substudy 1: Double-blind Risankizumab Dose 1|Substudy 1: Double-blind Risankizumab Dose 2|Substudy 2: Open-label Risankizumab Dose 1|Substudy 2: Open-label Risankizumab Dose 2|Substudy 3: Open-label Extension Risankizumab","Participants randomized to receive placebo for risankizumab administered by subcutaneous (SC) injection.|Participants randomized to receive risankizumab dose 1 administered by subcutaneous (SC) injection.|Participants randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection.|Participants who completed Sub-study 1 or 2 receive open-label risankizumab in Sub-study 3.","Drug","placebo for risankizumab|risankizumab","subcutaneous (SC) injection","ABBV-066 | BI 655066\n | SKYRIZI","Substudy 1: Double-blind Placebo|Substudy 1: Double-blind Risankizumab Dose 1|Substudy 1: Double-blind Risankizumab Dose 2|Substudy 2: Open-label Risankizumab Dose 1|Substudy 2: Open-label Risankizumab Dose 2|Substudy 3: Open-label Extension Risankizumab","\n\n- Participants who have completed Study M16-065 or Study M16-067 and have achieved clinical response as defined in the protocol\n\n","\n\n * Participants who have a known hypersensitivity to risankizumab or the excipients of any of the study drugs or the ingredients of chinese hamster ovary (CHO) or had an adverse event (AE) during Studies M16-065 or M16-067 that in the Investigator's judgment makes the participant unsuitable for this study\n * Participant is considered by the Investigator, for any reason, to be an unsuitable candidate for the study\n * Participant is not in compliance with prior and concomitant medication requirements throughout Studies M16-065 and M16-067",{"$nulls":4},"Actual","2018-01-12","Actual","Anticipated","2023-11-07","Anticipated","2020-05-01","2018-01-08","2018-01-08","2020-05-20","Yes","ABBV-066\nBI 655066","Interventional","Treatment","Parallel Assignment","Triple (Participant, Investigator, Outcomes Assessor)","Randomized","16 Years","80 Years","All",null,"No","Yes\nAbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",null,"URL: https://www.rxabbvie.com [https://www.rxabbvie.com] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.",null,"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2016-004676-22","EudraCT Number","Sub-Study 1: Percentage of Participants with Clinical Remission per Adapted Mayo Score","Clinical remission per Adapted Mayo Score.","Week 52","Sub-Study 1: Percentage of Participants with Endoscopic Remission|Sub-Study 1: Percentage of Participants with Clinical Remission per Full Mayo Score in Participants with a Full Mayo Score of 6 to 12 at Baseline (of Induction)|Sub-Study 1: Percentage of Participants who Discontinued Corticosteroid Use, Remained Corticosteroid Free for 90 days, and Achieved Clinical Remission per Adapted Mayo Score in Participants Taking Steroids at Baseline (of induction).|Sub-Study 1: Percentage of Participants with Clinical Remission per Adapted Mayo Score in Participants with a Clinical Remission at Week 0|Sub-Study 1: Percentage of Participants who Discontinued Corticosteroid Use in Participants who were Taking Steroids at Baseline (of induction)|Sub-Study 1: Percentage of Participants with Endoscopic Improvement in Participants with Endoscopic Improvement at Week 0|Sub-Study 1: Percentage of Participants with Clinical Response per Adapted Mayo Score|Sub-Study 1: Percentage of Participants with Endoscopic Improvement|Sub-Study 1: Percentage of Participants with Hospitalization|Sub-Study 1: Change in Ulcerative Colitis Symptom Questionnaire (UC-SQ)|Sub-Study 1: Percentage of Participants with Histologic Remission|Sub-Study 1: Percentage of Participants with Mucosal Healing|Sub-Study 1: Change in Inflammatory Bowel Disease Questionnaire (IBDQ)|Sub-Study 1: Percentage of Participants with Ulcerative Colitis (UC)-Related Surgeries|Sub-Study 1: Change in 36-Item Short Form Health Status Survey (SF-36)|Sub-Study 1: Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)|Sub-Study 1: Percentage of Participants with Stool Frequency Subscore (SFS), Rectal Bleeding Subscore (RBS), and Endoscopic Subscore of 0|Sub-Study 1: Percentage of Participants with Stool Frequency Subscore (SFS) â‰¤ 1|Sub-Study 1: Percentage of Participants with Rectal Bleeding Subscore (RBS) = 0|Sub-study 1: Change from Baseline of Induction in Partial Adapted Mayo Score|Sub-Study 1: Change in Full Mayo Score|Sub-Study 1: Change in SFS|Sub-Study 1: Change in RBS|Sub-Study 1: Change in High Sensitivity C-reactive Protein (hs-CRP)|Sub-Study 1: Change in Fecal Calprotectin (FCP)|Sub-Study 1: Change from Baseline in Ulcerative Colitis Endoscopic Index of Severity (UCEIS)|Sub-Study 1: Change in European Quality of Life 5 Dimensions (EQ-5D-5L)|Sub-Study 1: Change in Work Productivity and Impairment Questionnaire - UC (WPAI UC)|Sub-study 1: Time to Loss of Clinical Response per Partial Adapted Mayo in Patients with Response per Partial Adapted Mayo|Sub-Study 1: Change in Patient Global Impression of Severity (PGIS)|Sub-Study 1: Change in Patient Global Impression of Change (PGIC) scores|Sub-Study 1: Percentage of Participants who Discontinued Corticosteroid Use, in Participants Taking Steroids at Baseline (of Induction).|Sub-Study 1: Percentage of Participants who Discontinued Corticosteroid Use and Achieved Clinical Remission, in Participants Taking Steroids at Baseline (of Induction).|Sub-Study 1: Percentage of Participants who Discontinued Corticosteroid Use for 90 Days and Achieved Clinical Remission, in Participants Taking Steroids at Baseline (of Induction).|Sub-Study 1: Percentage of Participants who Discontinued Corticosteroid Use for 90 Days and SFS â‰¤ 1 (and not Worse than Baseline of Induction) and RBS = 1 and Achieved Clinical Remission, in Participants Taking Steroids at Baseline (of Induction).|Sub-Study 3: Percentage of Participants with Clinical Response per Partial Adapted Mayo Score|Sub-Study 3: Percentage of Participants with Clinical Remission per Adapted Mayo Score with Endoscopy|Sub-Study 3: Percentage of Participants with Clinical Response per Adapted Mayo Score with Endoscopy|Sub-Study 3: Time to Loss of Clinical Response per Partial Mayo Score|Sub-Study 3: Time to Loss of Clinical Remission per Adapted Mayo Score with Endoscopy|Sub-Study 3: Time too Loss of Clinical Response per Adapted Mayo Score with Endoscopy|Sub-Study 3: Percentage of Participants Who Discontinued Corticosteroid Use with Clinical Response per Partial Adapted Mayo Score in Participants Taking Steroids at Baseline (of Induction).|Sub-Study 3: Percentage of Participants with Endoscopic Improvement|Sub-Study 3: Percentage of Participants with Endoscopic Remission|Sub-Study 3: Percentage of Participants with Mucosal Healing|Sub-Study 3: Percentage of Participants with Histologic Remission|Sub-Study 3: Change in Ulcerative Colitis Symptom Questionnaire (UC-SQ)|Sub-Study 3: Percentage of Participants with Hospitalization|Sub-Study 3: Percentage of Participants with Ulcerative Colitis (UC)-Related Surgeries|Sub-Study 3: Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)|Sub-Study 3: Change in 36-Item Short Form Health Status Survey (SF-36)|Sub-Study 3: Change in Inflammatory Bowel Disease Questionnaire (IBDQ)|Sub-Study 3: Change in Work Productivity and Impairment Questionnaire - UC (WPAI UC)|Sub-Study 3: Change in European Quality of Life 5 Dimensions (EQ-5D-5L)|Sub-Study 3: Change in RBS|Sub-Study 3: Change in SFS|Sub-Study 3: Change in Fecal Calprotectin (FCP)|Sub-Study 3: Change in High Sensitivity C-reactive Protein (hs-CRP)|Sub-Study 3: Change in Patient Global Impression of Severity (PGIS)|Sub-Study 3: Change in Patient Global Impression of Change (PGIC) scores|Sub-Study 3: Percentage of Participants Who Discontinued Corticosteroid Use, in Participants Taking Steroids at Baseline (of Induction).","Endoscopic remission per endoscopy subscore.|Clinical remission per full Mayo Score.|Clinical remission per Adapted Mayo Score.|Participants who discontinued corticosteroid use.|Endoscopic improvement per endoscopy subscore.|Clinical response per Adapted Mayo score.|Participants with an event that results in admission to the hospital.|The UC-SQ is a patient questionnaire to assess severity of ulcerative colitis symptoms.|Histologic remission per Geboes Score.|Mucosal healing defined as endoscopic and histologic remission.|The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.|Participants who underwent surgery related to UC.|The SF-36 is an indicator of overall health status.|The FACIT-Fatigue is a validated tool that measures an individual's level of fatigue during their usual daily activities over the past week.|The SFS, RBS, and endoscopic subscore describe disease severity.|The Stool Frequency Subscore ranges from 0 (normal) to 3 (severe disease). A negative change in Stool Frequency Subscore indicates improvement.|The Rectal Bleeding Subscore ranges from 0 (normal) to 3 (severe disease). A negative change in Rectal Bleeding Subscore indicates improvement.|The Partial Adapted Mayo Score is a composite of the following sub-scores: SFS and RBS.|The Full Mayo Score ranges determines disease severity. A negative change in Full Mayo Score indicates improvement.|High sensitivity C-reactive protein was analyzed by a central laboratory. The median percent change from week 0 in CRP is assessed at each time point.|Stool samples were analyzed by a central laboratory for fecal calprotectin (FCP)qualitative measurement. Results are reported for participants in each category.|The Ulcerative Colitis Endoscopic Index of Severity (UCEIS) is defined as an assessment of the endoscopy findings scoring system for additional exploratory analyses.|The European Quality of Life 5 Dimensions (EQ-5D-5L) is a standardized instrument used to measure health-related quality of life that can be used in a wide range of health conditions and treatments.|The WPAI UC questionnaire was used to assess work and activity impairment due to symptoms of ulcerative colitis. The self-administered questionnaire measures the effect of the participant's health problems on work and daily activities in the previous week, specifically, the number of hours missed from work due to health problems, how much the subject's health problems affected work productivity, and how much the subject's health problems affected regular activities. Low scores indicate little or no impact of health problems on work and activities, and a negative change in the WPAI score indicates improvement.|The PGIS is a response scale that describes the severity of the participants disease.|The PGIC is a response scale. The participant will be asked by the Investigator or qualified designee to rate their change in their disease status.|Participants who discontinued corticosteroid use, in participants taking steroids at baseline (of induction).|Clinical remission per Adapted Mayo score, in participants taking steroids at baseline (of induction).|The Partial Adapted Mayo Score is a composite of the following sub-scores: SFS and RBS, in participants taking steroids at baseline (of induction).","Week 52|Through Week 52|Week 0 to Week 52|At Week 52|At Week 0|Through Week 300|Week 0 to Week 300","abbvieclinicaltrials@abbvie.com","ABBVIE CALL CENTER","847.283.8955",{"$cut":{"chars":22644,"head":"Buenos Aires, Argentina, 1431 Sanatorio 9 De Julio S.A. /Id# 167803San Miguel De Tucuman, Argentina, 4000|Rosario, Santa Fe, Argentina, 2000|Graz, Austria, 8036 Universitaetsklinik Fuer Innere Medizin 1 /Id# 200686Salzburg, Austria, 5020|St. PÃ¶lten, Niederoesterreich, Austria, 3100|Linz, Oberoesterreich, Austria, 4010|Vienna, Wien, Austria, 1090|Brussels, Bruxelles-Capitale, Belgium, 1070 Cliniques Universitaires Saint Luc /Id# 200260Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200|Bonheiden, Belgium, 2820 Uz Leuven /Id# 170829Leuven, Belgium, 3000 Chu De Liege /Id# 200257Liege, Belgium, 4000 Groupe Sante Chc - Clinique Du Montlegia /Id# 200255Liege, Belgium, 4000 Az-Delta /Id# 200258Roeselare, Belgium, 8800 Chu Dinant Godinne - Ucl Namur /Id# 200259Yvoir, Belgium, 5530|Goiania, Goias, Brazil, 74535-170|Curitiba, Parana, Brazil, 80810-040|Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903|Botucatu, Sao Paulo, Brazil, 18618-686 Hospital Das Clinicas Da Faculdade De Medicina De RibeirÃ£o Preto - Usp /Id# 157668RibeirÃ£o Preto, Sao Paulo, Brazil, 14048-900 Faculdade De Medicina Do Abc /Id# 163993Santo AndrÃ©, Sao Paulo, Brazil, 09060-870 Kaiser Clinica E Hospital Dia /Id# 157686Sao Jose Do Rio Preto, Sao Paulo, Brazil, 15015-110|Sliven, Bulgaria, 8800 Ii Mhat - Sofia /Id# 200794Sofia, Bulgaria, 1202 Umhat Tsaritsa Joanna - Isul /Id# 209978Sofia, Bulgaria, 1527 Umhat Sv. Ivan Rilski /Id# 210798Sofia, Bulgaria, 1612|Calgary, Alberta, Canada, T2N 4Z6 Allen Whey Khye Lim Professional Corporation /Id# 169770Edmonton, Alberta, Canada, T5R 1W2 Zeidler Ledcor Centre /Id# 204589Edmonton, Alberta, Canada, T6G 2X8 Covenant Health /Id# 169128Edmonton, Alberta, Canada, T6L 6K3|New Westminster, British Columbia, Canada, V3L 3W4 Percuro Clinical Research, Ltd /Id# 169123Victoria, British Columbia, Canada, V8V 3M9|Halifax, Nova Scotia, Canada, B3K 6R8|London, Ontario, Canada, N6A 5A5 Scott Shulman Medicine Professional Corporation /Id# 169127North Bay, Ontario, Canada, P1B 2H3 Toronto Digestive Diseases Ass /Id# 169120Vaughan, Ontario, Canada, L4L 4Y7|Greenfield Park, Quebec, Canada, J4V 2H1 Hopital Hotel-Dieu De Levis /Id# 214379Levis, Quebec, Canada, G6V 3Z1 Ciusss De L'Est De L'Ile De MontrÃ©al /Id# 169122MontrÃ©al, Quebec, Canada, H1T 2M4 Montreal General Hospital /Id# 169118MontrÃ©al, Quebec, Canada, H3G 1A4|Victoria, Araucania, Chile, 4720843|ConcepciÃ³n, Chile, 4070038 Hospital Las Higueras /Id# 167094Talcahuano, Chile|Santiago, Region Metropolitana De Santiago, Chile, 8207257 Servicio De Salud Occidente Hospital San Juan De Dios /Id# 171124Santiago, Region Metropolitana De Santiago, Chile, 8350488|Hefei, Anhui, China, 230022|Beijing, China, 100050 Peking University Third Hospital /Id# 221022Beijing, China, 100083 The Second Xiangya Hospital Of Central South University /Id# 211196Changsha, China, 410000 Jiangsu Province Hospital /Id# 211234Nanjing, China, 210029 Shanghai Dongfang Hospital /Id# 218796Shanghai, China, 200120 Shengjing Hospital Of|Guangzhou, Guangdong, China, 510655|Shijiazhuang, Hebei, China, 050005|Chengdu, Sichuan, China, 610041|Changsha, Hunan, China, 410008|Wuxi, Jiangsu, China, 214023|Nanchang, Jiangxi, China, 330006|Changchun, Jilin, China, 130021|Shenyang, China, 110004 Union Hospital Tongji Medical College Huazhong University Of Science And Technol /Id# 211070Wuhan, China, 430022 Tongji Hosp Tongji Med College /Id# 211069Wuhan, China, 430030 Renmin Hospital Of Wuhan Univ /Id# 212867Wuhan, China, 430060 4Th Military Medical Universit /Id# 215505Xi'An, China, 710038|Yinchuan, Ningxia, China, 750004|Xian, Shaanxi, China, 710032|Shanghai, Shanghai, China, 200025 Renji Hospital, Shanghai Jiaotong University School Of Medicine /Id# 211230Shanghai, Shanghai, China, 200127|Hangzhou, Zhejiang, China, 310009 Sir Run Run Shaw Hospital /Id# 211062Hangzhou, Zhejiang, China, 310016|Bogota Dc, Cundinamarca, Colombia, 11411|Medellin, Colombia, 50010 Inst Med Alta Tec Onc (Imat) /Id# 207041MonterÃ­a, Colombia, 230002|Zagreb, Grad Zagreb, Croatia, 10000 Klinicki Bolnicki Centar Zagreb /Id# 157594Zagreb, Grad Zagreb, Cro"}},"California|Colorado|Connecticut|Florida|Georgia|Illinois|Indiana|Kansas|Louisiana|Maryland|Massachusetts|Michigan|Minnesota|Nebraska|New York|North Carolina|North Dakota|Ohio|Oklahoma|Pennsylvania|South Carolina|Tennessee|Texas|Utah|Virginia|Washington","Argentina|Austria|Belgium|Brazil|Bulgaria|Canada|Chile|China|Colombia|Croatia|Denmark|Egypt|France|Germany|Greece|Hungary|Israel|Italy|Japan|Latvia|Lithuania|Malaysia|Mexico|Netherlands|New Zealand|Poland|Portugal|Romania|Serbia|Singapore|Slovakia|Slovenia|South Africa|Spain|Sweden|Switzerland|Turkey|Ukraine|United Kingdom|United States","Centro De EducaciÃ³n MÃ©dica E Investigaciones ClÃ­nicas \"Norberto Quimo\" - Cemic /Id# 167805|Santa Fe Hopital Centenario /Id# 170896|Lkh-Univ. Klinikum Graz /Id# 169052|Niederoesterreich UniversitÃ¤tsklinikum St.PÃ¶lten /Id# 169049|Oberoesterreich Kh Der Elisabethinen Linz Gmbh /Id# 216043|Wien Medical University Of Vienna /Id# 169051|Bruxelles-Capitale Cub Hospital Erasme /Id# 200256|Imelda Ziekenhuis /Id# 211101|Goias Instituto Goiano De Gastroenterologia E Endoscopia Digestiva Ltda /Id# 157683|Parana Hospital Nossa Senhora Das GraÃ§as /Id# 157677|Rio Grande Do Sul Hospital De Clinicas De Porto Alegre /Id# 157670|Sao Paulo Upeclin Fmb - Unesp /Id# 157691|Mbal Hadzhi Dimitar /Id# 207947|Alberta University Of Calgary /Id# 169125|British Columbia Fraser Clinical Trials Inc /Id# 169116|Nova Scotia Iwk Health Center /Id# 169124|Ontario London Health Sciences Centre /Id# 169117|Quebec Hopital Charles-Lemoyne /Id# 169119|Araucania Servicio De Salud AraucanÃ­a Norte Hospital Victoria /Id# 213152|Hospital Guillermo Grant Benavente De ConcepciÃ³n /Id# 210762|Region Metropolitana De Santiago Complejo Asistencial Dr. Sotero Del Rio /Id# 169386|Anhui The First Affiliated Hospital Of Anhui Medical University /Id# 211227|Beijing Friendship Hospital /Id# 211061|Guangdong The Sixty Affiliated Hospital Of Sun Yat-Sen University /Id# 211229|Hebei The Second Hospital Of Hebei Medical University /Id# 213019|Hospital /Id# 211275|Hunan Xiangya Hospital Central South University /Id# 211195|Jiangsu Wuxi People's Hospital /Id# 218797|Jiangxi 1St Aff Hosp Nanchang Univ /Id# 212182|Jilin The First Hosp Of Jilin Univ /Id# 212277|Medical University /Id# 211643|Ningxia General Hospital Of Ningxia Medical University /Id# 213912|Shaanxi Xijing Hospital /Id# 210708|Shanghai Ruijin Hospital, Shanghai Jiaotong /Id# 210960|Zhejiang The Second Affiliated Hospital Of Zhejiang University School Of Medicine /Id# 211024|Cundinamarca Corporacion Hospitalaria Juan Ciudad Sede Denominada Hospital Universitario Mayo /Id# 158736|Hospital Universitario San Vic /Id# 171488|Grad Zagreb Klinicka Bolnica Dubrava Zagreb /Id# 157598|Klinicki Bolnicki Centar Split /Id# 157596|Osjecko-Baranjska Zupanija Klinicki Bolnicki Centar Osijek /Id# 157595|Hovedstaden Bispebjerg Hospital /Id# 208953|Hvidovre Hospital /Id# 205093|SjÃ¦lland Sjaellands Universitets Hospit /Id# 200073|Clinical Research Center, Faculty Of Medicine, Alexandria University. /Id# 201824|Alpes-Maritimes Chu De Nice-Hopital L'Archet Ii /Id# 207881|Chu Amiens Picardie - Site Sud /Id# 207880|Gironde HÃ´pital Haut-LÃ©vÃªque /Id# 207883|Hopital Beaujon /Id# 207876|Loire Chu De Saint Etienne - Hopital Nord /Id# 207882|Baden-Wuerttemberg Universitatsklinikum Mannheim /Id# 162039|Bayern Universitaetsklinikum Erlangen /Id# 159373|Nordrhein-Westfalen Uniklinik Koln /Id# 164993|Praxis Am Bayrischen Platz /Id# 159380|Schleswig-Holstein Univ Hosp Schleswig-Holstein, Campus Kiel, Klinik Furer Innere Medizin /Id# 159379|Thueringen Universitaetsklinikum Ulm /Id# 164994|Attiki General Hospital Of Athens Laiko /Id# 206438|General Hospital Of Chest Diseases Of Athens Sotiria /Id# 170910|Baranya Mohacsi Korhaz /Id# 205285|Borsod-Abauj-Zemplen Miskolci Semmelweis Korhaz Es /Id# 201281|Heves Bugat Pal Korhaz /Id# 202526|Magyar Honvedseg Egeszsegugyi Kozpont /Id# 157338|Pest Obudai Egeszsegugyi Kozpont /Id# 201921|Hadarom Soroka Medical Center /Id# 171093|Rambam Medical Center /Id# 171094|Tel-Aviv Rabin Medical Center /Id# 167402|Yerushalayim Hadassah Medical Center-Hebrew University /Id# 171092|Calabria Universita Di Catanzaro Magna Graecia /Id# 200124|Emilia-Romagna Ospedale Sant Orsola Malpighi /Id# 155627|Lazio Policlinico Universitario Campus Bio-Medico /Id# 163994|Lombardia Asst Rhodense /Id# 211450|Milano Ibd Center - Irccs Istituto Clinico Humanitas /Id# 155626|Ospedale Policlinico San Martino - Irccs /Id# 164030|Sicilia A.O. Per L'Emergenza Cannizzaro /Id# 164039|Verona Ospedale Classificato Equiparato Sacro Cuore-Don Calabria /Id# 164029|Aichi Aichi Medical University Hosp /Id# 164227|Chiba Toho University Sakura Medical Center /Id# 164219|Fukuoka Fukuoka University Chikushi Hospital /Id# 209056|Gifu Gifu University Hospital /Id# 208490|Gunma National Hospital Organization Takasaki General Medical Center /Id# 164312|Hiroshima Nho Fukuyama Medical Center /Id# 164315|Hokkaido Asahikawa Medical University Hospital /Id# 164324|Hyogo Aoyama Clinic /Id# 164236|Ishikawa Kanazawa University Ho /Id# 169221|Kanagawa Gokeikai Ofuna Chuo Hospital /Id# 169296|Mie Mie University Hospital /Id# 203635|Miyagi Tohoku University Hospital /Id# 164276|Nagasaki Nagasaki University Hospital /Id# 205326|Saga Saga University Hospital /Id# 209273|Saitama Tokito Clinic /Id# 164218|Shiga Shiga University Of Medical Science Hospital /Id# 164323|Tokai University Hospital /Id# 209207|Tokyo Medical Hospital Of Tokyo Medical And Dental University /Id# 164225|Wakayama Wakayama Medical University /Id# 169485|Yamagata Yamagata University Hospital /Id# 171481|Riga East Clinical Univ Hosp /Id# 160204|Kaunas Hospital Of Lithuanian Univers /Id# 201142|Vilnius University Hospital /Id# 201144|/Id# 200633|Selangor Ukm Medical Centre /Id# 200634|Health Pharma Professional Research S.A De C.V /Id# 206516|Morelos Jm Research Sc /Id# 206518|Elisabeth Tweesteden Ziekenhuis /Id# 163738|Noord-Holland Academisch Medisch Centrum /Id# 157965|, Bay Of Plenty Tauranga Hospital /Id# 212793|, Canterbury Christchurch Hospital /Id# 205337|, Waikato Waikato Hospital /Id# 212788|Hutt Valley Dist Health Board /Id# 212787|Dolnoslaskie Vistamed /Id# 210106|Malopolskie Centrum Medyczne Plejady /Id# 170635|Mazowieckie Centrum Zdrowia Mdm /Id# 170283|Nzoz Vitamed /Id# 213358|Slaskie Nzoz All-Medicus /Id# 170282|Zachodniopomorskie Endoskopia Sp. Z O.O. /Id# 170284|Centro Hospitalar E UniversitÃ¡rio De Coimbra, Epe /Id# 166050|Faro Centro Hospitalar Do Algarve - Hospital De PortimÃ£o /Id# 166563|Lisboa Centro Hosp De Lisboa Central /Id# 165578|Setubal Hospital Garcia De Orta, E.P.E /Id# 165579|Institutul Clinic Fundeni /Id# 171259|/Id# 200153|Sumadijski Okrug Clinical Center Kragujevac /Id# 156879|Fn S Poliklinikou F.D. Rooseve /Id# 164348|Univ Medical Ctr Ljubljana /Id# 210628|, Free State Farmovs (Pty) Ltd /Id# 207538|, Western Cape Allergy & Immunology (Aiu) /Id# 171439|Dr Jp Wright /Id# 171142|Galicia Complejo Hospitalario Universitario De Ferrol /Id# 159463|Hospital Universitario Parc Tauli /Id# 159473|Pontevedra Hospital Alvaro Cunqueiro /Id# 167359|Su Molndal. /Id# 202841|Vastra Gotalands Lan AlingsÃ¥s Lasarett /Id# 202075|Zuerich University Hospital Zurich /Id# 202908|Ankara Univ Medical Faculty /Id# 167205|Istanbul Acibadem Kozyatagi Hospital /Id# 213277|Kayseri Erciyes University Medical Fac /Id# 171283|Kyivska Oblast Medical Centre Ok Clinic Of International Institute Of Clinical Research Llc /Id# 205484|Regional Clinical Hospital /Id# 203366|, Devon Rd&E Hospital /Id# 157614|Barnsley Hospital Nhs Foundation Trust /Id# 202771|Southern California Res. Ctr. /Id# 169659|Peak Gastroenterology Associat /Id# 165838|Medical Research Ctr Ct /Id# 160287|South Lake Pain Institute, Inc /Id# 162859|Gastro Assoc Of Central Ga /Id# 160513|University Of Chicago /Id# 160511|Indiana University /Id# 167250|Cotton-O'Neil Clinical Res Ctr /Id# 160367|Houma Digestive Health Special /Id# 158377|Johns Hopkins University School Of Medicine /Id# 211792|Mgh Digestive Health Center /Id# 164257|University Of Michigan Hospitals /Id# 159430|Mayo Clinic - Rochester /Id# 200455|Quality Clinical Research Inc. /Id# 167312|Manhattan Clinical Research, Llc /Id# 211803|Atrium Health Carolinas Medical Center /Id# 158543|Plains Clinical Research Center, Llc /Id# 169729|Cleveland Clinic Main Campus /Id# 209235|Digestive Disease Specialists /Id# 170777|University Of Pennsylvania /Id# 166262|Gastroenterology Associates, P.A. /Id# 160457|Gastro One /Id# 160373|Inquest Clinical Research /Id# 165686|Advanced Research Institute /Id# 160465|Pediatric Specialty Of Va /Id# 166819|Virginia Mason Medical Center /Id# 160432",{"$nulls":3},"AbbVie Inc.","2020-05-20","2020-05-25T16:36:33.439","2020-05-26T17:10:42.972","NCT03398135"]
["5ecbf412feab101b1553086d","NCT03398148","2018-01-12","AbbVie","ABBV","Not yet recruiting","A Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy","Risankizumab","IL23 Inhibitor","Yes","['Risankizumab']","No",null,"Phase 2",15,720,"Anticipated","2018-03-07","2020-09-23",{"$nulls":5},"The objectives of Sub-Study 1 are to evaluate the efficacy, safety, and pharmacokinetics of risankizumab as induction treatment in subjects with moderately to severely active ulcerative colitis (UC), and to identify the appropriate induction dose of risankizumab for further evaluation in Sub-Study 2.\n\nThe objective of Sub-Study 2 is to evaluate the efficacy and safety of risankizumab compared to placebo in inducing clinical remission in subjects with moderately to severely active UC.",null,"A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy","M16-067","Ulcerative Colitis","Colitis|Colitis, Ulcerative","Gastrointestinal Diseases","Gastrointestinal","Placebo Comparator|Experimental","Substudy 1, Induction 1: Double-blind Placebo|Substudy 1, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 2|Substudy 1, Induction 1: Double-blind Risankizumab Dose 3|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 1, Induction 2: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 3|Substudy 2, Induction 1: Double-blind Placebo|Substudy 2, Induction 1: Double-blind Risankizumab Dose 1|Substudy 2, Induction 1: Open-label Risankizumab Dose 2|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 2, Induction 2: Double-blind Risankizumab Dose 2|Substudy 2, Induction 2: Double-blind Risankizumab Dose 3","Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.|Participants randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion.|Participants randomized to receive risankizumab dose 2 administered by intravenous (IV) infusion.|Participants randomized to receive risankizumab dose 3 administered by intravenous (IV) infusion.|Participants who received placebo with inadequate response in Induction 1 receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.|Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.|Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection in Induction 2.|Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 3 administered by subcutaneous (SC) injection in Induction 2.|Participants who received placebo with inadequate response in Induction 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.","Drug","risankizumab IV|placebo for rizankizumab|rizankizumab SC","rizankizumab intravenous (IV) infusion|placebo for rizankizumab|rizankizumab subcutaneous (SC) injection","ABBV-066 | BI 655066","Substudy 1, Induction 1: Double-blind Placebo|Substudy 1, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 2|Substudy 1, Induction 1: Double-blind Risankizumab Dose 3|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 1, Induction 2: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 3|Substudy 2, Induction 1: Double-blind Placebo|Substudy 2, Induction 1: Double-blind Risankizumab Dose 1|Substudy 2, Induction 1: Open-label Risankizumab Dose 2|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 2, Induction 2: Double-blind Risankizumab Dose 2|Substudy 2, Induction 2: Double-blind Risankizumab Dose 3","\n\n * Male or female aged >=18 to <= 80 years at the Baseline Visit. Where locally permissible, subjects 16 to < 18 years of age who meet the definition of Tanner stage 5 for development at the Baseline Visit\n * Confirmed diagnosis of ulcerative colitis (UC) for at least 3 months prior to Baseline.\n * Active UC as assessed by adapted Mayo Score\n * Demonstrated intolerance or inadequate response to one or more biologic therapies\n * Females must be postmenopausal for more than 2 years or surgically sterile or practicing specific forms of birth control.\n\n","\n\n * Subject with a current diagnosis of Crohn's disease (CD), inflammatory bowel disease-unclassified (IBD-U) or a history of radiation colitis or ischemic colitis.\n * Subject receiving prohibited medications and treatment.\n * Extent of inflammatory disease limited to the rectum as assessed by screening endoscopy.\n * Subject with currently known complications of UC (e.g., megacolon).",{"$nulls":4},"Actual","2018-01-12","Actual","Anticipated","2021-07-23","Anticipated","2018-01-01","2018-01-08","2018-01-08","2018-01-08","Yes","ABBV-066\nBI 655066","Interventional","Treatment","Parallel Assignment","Triple (Participant, Investigator, Outcomes Assessor)","Randomized","16 Years","80 Years","All",null,"No","Undecided",{"$nulls":3},"Yes","No",{"$nulls":17},"2016-004677-40","EudraCT Number","Percentage of participants with clinical remission per adapted Mayo Score at Week 12","Clinical remission per adapted Mayo Score.","Week 12","Percentage of participants with endoscopic improvement at Week 12|Percentage of participants achieving clinical remission per full Mayo Score at Week 12 in subjects with a full Mayo score of 6 to 12 at Baseline|Percentage of participants achieving clinical response per adapted Mayo Score at week 12|Percentage of participants achieving clinical response per partial adapted Mayo Score at week 4|Percentage of participants with endoscopic remission at Week 12|Percentage of participants with hospitalization through Week 12|Percentage of participants with mucosal healing at Week 12|Ulcerative Colititis Symptom Questionnaire (UC-SQ): Change from Baseline to Week 12|Inflammatory Bowel Disease Questionnaire (IBDQ): Change from Baseline to Week 12|36-Item Short Form Health Status Survey (SF-36): Change from Baseline to Week 12|Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue): Change from Baseline to Week 12|Percentage of participants with Ulcerative Colitis (UC)-related surgeries through Week 12","Endoscopic improvement per endoscopy subscore.|Clinical remission per full Mayo Score.|Clinical response per adapted Mayo Score.|Clinical response per partial adapted Mayo Score (without endoscopy).|Endoscopic remission per endoscopy subscore.|Participants with an event that results in admission to the hospital.|Mucosal healing defined as endoscopic and histologic remission.|The US-SQ is a patient questionnaire to assess severity of Crohn's symptoms.|The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.|The SF-36 is an indicator of overall health status.|The FACIT-Fatigue is a validated tool that measures an individual's level of fatigue during their usual daily activities over the past week.|Participants who underwent surgery related to UC.","Week 12|Week 4|12 weeks|Baseline, Week 12","abbvieclinicaltrials@abbvie.com","AbbVie_Call Center","847.283.8955",{"$nulls":7},"Abbvie Inc","2018-01-08","2020-05-25T16:36:34.113","2020-05-26T17:10:42.972","NCT03398148"]
["5ecbf41211702c1b1b916a4d","NCT03398148","2018-03-12","AbbVie","ABBV","Recruiting","A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy","Risankizumab","IL23 Inhibitor","Yes","['Risankizumab']","No",null,"Phase 2/Phase 3",16,720,"Anticipated","2018-03-07","2020-09-23",{"$nulls":5},"The objectives of Sub-Study 1 are to evaluate the efficacy, safety, and pharmacokinetics of risankizumab as induction treatment in subjects with moderately to severely active ulcerative colitis (UC), and to identify the appropriate induction dose of risankizumab for further evaluation in Sub-Study 2.\n\nThe objective of Sub-Study 2 is to evaluate the efficacy and safety of risankizumab compared to placebo in inducing clinical remission in subjects with moderately to severely active UC.",null,"A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy","M16-067","Ulcerative Colitis","Colitis|Colitis, Ulcerative","Gastrointestinal Diseases","Gastrointestinal","Placebo Comparator|Experimental","Substudy 1, Induction 1: Double-blind Placebo|Substudy 1, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 2|Substudy 1, Induction 1: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Open-label Risankizumab Dose 3|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 1, Induction 2: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 3|Substudy 2, Induction 1: Double-blind Placebo|Substudy 2, Induction 1: Double-blind Risankizumab Dose 1|Substudy 2, Induction 1: Open-label Risankizumab Dose 2|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 2, Induction 2: Double-blind Risankizumab Dose 2|Substudy 2, Induction 2: Double-blind Risankizumab Dose 3","Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.|Participants randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion.|Participants randomized to receive risankizumab dose 2 administered by intravenous (IV) infusion.|Participants receive risankizumab dose 3 administered by intravenous (IV) infusion.|Participants who received placebo with inadequate response in Induction 1 receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.|Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.|Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection in Induction 2.|Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 3 administered by subcutaneous (SC) injection in Induction 2.|Participants who received placebo with inadequate response in Induction 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.","Drug","placebo for rizankizumab|risankizumab IV|rizankizumab SC","placebo for rizankizumab|rizankizumab intravenous (IV) infusion|rizankizumab subcutaneous (SC) injection","ABBV-066 | BI 655066","Substudy 1, Induction 1: Double-blind Placebo|Substudy 1, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 2|Substudy 1, Induction 1: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Open-label Risankizumab Dose 3|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 1, Induction 2: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 3|Substudy 2, Induction 1: Double-blind Placebo|Substudy 2, Induction 1: Double-blind Risankizumab Dose 1|Substudy 2, Induction 1: Open-label Risankizumab Dose 2|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 2, Induction 2: Double-blind Risankizumab Dose 2|Substudy 2, Induction 2: Double-blind Risankizumab Dose 3","\n\n * Male or female aged >=18 to <= 80 years at the Baseline Visit. Where locally permissible, subjects 16 to < 18 years of age who meet the definition of Tanner stage 5 for development at the Baseline Visit\n * Confirmed diagnosis of ulcerative colitis (UC) for at least 3 months prior to Baseline.\n * Active UC as assessed by adapted Mayo Score\n * Demonstrated intolerance or inadequate response to one or more biologic therapies\n * Females must be postmenopausal for more than 2 years or surgically sterile or practicing specific forms of birth control.\n\n","\n\n * Subject with a current diagnosis of Crohn's disease (CD), inflammatory bowel disease-unclassified (IBD-U) or a history of radiation colitis or ischemic colitis.\n * Subject receiving prohibited medications and treatment.\n * Extent of inflammatory disease limited to the rectum as assessed by screening endoscopy.\n * Subject with currently known complications of UC (e.g., megacolon).",{"$nulls":4},"Actual","2018-01-12","Actual","Anticipated","2021-12-25","Anticipated","2018-03-01","2018-01-08","2018-01-08","2018-03-08","Yes","ABBV-066\nBI 655066","Interventional","Treatment","Parallel Assignment","Double (Participant, Investigator)","Randomized","16 Years","80 Years","All",null,"No","Undecided",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2016-004677-40","EudraCT Number","Percentage of participants with clinical remission per adapted Mayo Score at Week 12","Clinical remission per adapted Mayo Score.","Week 12","Percentage of participants achieving clinical remission per full Mayo Score at Week 12 in subjects with a full Mayo score of 6 to 12 at Baseline|Ulcerative Colitis Symptom Questionnaire (UC-SQ): Change from Baseline to Week 12|Inflammatory Bowel Disease Questionnaire (IBDQ): Change from Baseline to Week 12|Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue): Change from Baseline to Week 12|Percentage of participants achieving clinical response per adapted Mayo Score at week 12|Percentage of participants with endoscopic remission at Week 12|Percentage of participants achieving clinical response per partial adapted Mayo Score at week 4|Percentage of participants with mucosal healing at Week 12|36-Item Short Form Health Status Survey (SF-36): Change from Baseline to Week 12|Percentage of participants with hospitalization through Week 12|Percentage of participants with Ulcerative Colitis (UC)-related surgeries through Week 12|Percentage of participants with endoscopic improvement at Week 12","Clinical remission per full Mayo Score.|The US-SQ is a patient questionnaire to assess severity of Crohn's symptoms.|The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.|The FACIT-Fatigue is a validated tool that measures an individual's level of fatigue during their usual daily activities over the past week.|Clinical response per adapted Mayo Score.|Endoscopic remission per endoscopy subscore.|Clinical response per partial adapted Mayo Score (without endoscopy).|Mucosal healing defined as endoscopic and histologic remission.|The SF-36 is an indicator of overall health status.|Participants with an event that results in admission to the hospital.|Participants who underwent surgery related to UC.|Endoscopic improvement per endoscopy subscore.","Week 12|Baseline, Week 12|Week 4|12 weeks","abbvieclinicaltrials@abbvie.com","ABBVIE CALL CENTER","847.283.8955","Buenos Aires, Argentina, 1431 Hospital Britanico De Bs AsCaba, Argentina, 1280 Hosp Privado Ctr Med CordobaCordoba, Argentina, 5016 Sanatorio GuemesCuidad Autonoma De Buenosaires, Argentina, C1180Aad Instituto Medico CerQuilmes, Argentina, 1878 Sanatorio 9 De Julio S.A.San Miguel De Tucuman, Argentina, 4000 Hopital CentenarioSanta Fe, Argentina, 2000|Graz, Austria, 8036 Lkh Salzburg And ParacelsusSalzburg, Austria, 5020|St. PÃ¶lten, Niederosterreich, Austria, 3100|Vienna, Wein, Austria, 1090|Brussels, Bruxelles-Capitale, Belgium, 1070 Cliniques Universitaires Saint LucWoluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200|Liege, Liege, Belgium, 4000|Gent, Oost-Vlaanderen, Belgium, 9000|Jette, Brussels, Belgium, 1090 Uz LeuvenLeuven, Belgium, 3000 Clinique St JosephLiege, Belgium, 4000 Az-DeltaRoeselare, Belgium, 8800 Chu Dinant Godinne - Ucl NamurYvoir, Belgium, 5530|Goiania, Goias, Brazil, 74535-170|Curitiba, Parana, Brazil, 80810-040|Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903|Botucatu, Sao Paulo, Brazil, 18618-686 Hospital Das Clinicas Da Faculdade De Medicina De RibeirÃ£o Preto - UspRibeirÃ£o Preto, Sao Paulo, Brazil, 14048-900 Faculdade De Medicina Do AbcSanto AndrÃ©, Sao Paulo, Brazil, 09060-870 Kaiser Clinica E Hospital DiaSao Jose Do Rio Preto, Sao Paulo, Brazil, 15015-110|Plovdiv, Bulgaria, 4001 Ii Mhat - SofiaSofia, Bulgaria, 1202 Acibadem City Clinic TokudaSofia, Bulgaria, 1407|Santiago, Chile, 8207257 Hospital Clinico UniversidadSantiago, Chile, 8380456 Hospital Las HiguerasTalcahuano, Chile Centro De Investigaciones ClinVina Del Mar, Chile, 2540364|Zagreb, Grad Zagreb, Croatia, 10000 Klinicki Bolnicki Centar ZagrebZagreb, Grad Zagreb, Croatia, 10000|Split, Croatia, 21000|Osijek, Osjecko-Baranjska Zupanija, Croatia, 31000|Hradec Kralove, Czechia, 500 12 Nemocnice Pardubickeho Kraje,Pardubice, Czechia, 53203|Olomouc, Olomoucky Kraj, Czechia, 779 00|Praha, Praha 5, Czechia, 150 00|Aarhus C, Midtjylland, Denmark, 8000|Roskilde, SjÃ¦lland, Denmark, 4000|Nyborg, Denmark, 5800|Pessac Cedex, Gironde, France, 33604|Berlin, Germany, 14050 Praxis Fuer GastroenterologieHeidelberg, Germany, 69121 Universitaetsklinikum UlmUlm, Germany, 89081|KÃ¶ln, Nordrhein-Westfalen, Germany, 50937|Athens, Greece, 11527 General Uh Of HeraklionHeraklion, Greece, 71110 Univ Gen Hosp IoanninaIoannina, Greece, 45500 Agios Panteleimon General HospPireaus, Greece, 18454 Theageneio Cancer HospitalThessaloniki, Greece, 546 39|Debrecen, Hungary, 4031 Miskolci Semmelweis Korhaz EsKecskemet, Hungary, 6000 Tolna Megyei Onkormanyzat BalaSzekszÃ¡rd, Hungary, 7100|Be'Er Sheva, Israel, 85025 Rambam Medical CenterHaifa, Israel, 3525408 Shaare Zedek Medical CenterJerusalem, Israel, 91031 Hadassah Ein Kerem Medical CtrJerusalem, Israel, 91120 Sheba Medical CenterRamat Gan, Israel, 5262100|Petakh Tikva, Tel-Aviv, Israel, 4941492|Catanzaro, Calabria, Italy, 88100|Bologna, Emilia-Romagna, Italy, 40138|Genoa, Italy, 16132 Azienda Ospedaliera Ospedale NMilano, Italy, 20162 Azienda Ospedaliera Luigi SaccMilan, Italy, 20157 Policlinico Tor VergataRome, Italy, 00133 Uoc Medicina Interna E GastroeRome, Italy, 168|Rome, Lazio, Italy, 00128 Azienda Ospedaliera San Camillo-ForlaniniRome, Lazio, Italy, 00152 Azienda Policlinico Universitario Umberto IRome, Lazio, Italy, 00161|Rozzano, Lombardia, Italy, 20089|Catania, Sicilia, Italy, 95126|Negrar, Verona, Italy, 37024|Nagoya-Shi, Aichi, Japan, 467-8602|Asahikawa-Shi, Japan, 078-8510 Nho Fukuyama Medical CenterFukuyama-Shi, Japan Hiroshima University HospitalHiroshima, Japan, 734-8551 Ofuna Chuo HospitalKamakura, Japan Kanazawa University HoKanazawa, Japan, 920-8641 The Jikei University HospitalMinato-Ku, Japan, 105-8471 Kitasato University Kitasato IMinato-Ku, Japan, 108-8642 Aichi Medical University HospNagakute, Japan, 480-1195 Kitasato University HospitalSagamihara-Shi, Japan, 252-0375 Tokito ClinicSaitama, Japan, 336-0963 Kyoto University HospitalSakyo-Ku, Japan, 606-8507 Sapporo Medical Univ HospSapporo, Japan, 060-8543 Nho Shizuoka Medical CenterShimizu-Sho, Japan National Hospital OrganizationTakasaki, Japan, 370-0829 Fujita Health University HospToyoake, Japan, 470-1192 Jp Red Cross Wakayama Med CtrWakayama, Japan Yokkaichi Hazu Medical CenterYokkaichi-Shi, Japan, 510-0016 Korea, Republic Of, Busan Gwang Yeogsi Dong-A University HospitalBusan, Busan Gwang Yeogsi, Korea, Republic Of, 49201 Pusan National University HospBusan, Busan Gwang Yeogsi, Korea, Republic Of, 602-739 Korea, Republic Of, Daegu Gwang Yeogsi Yeungnam University Med CtrDaegu, Daegu Gwang Yeogsi, Korea, Republic Of, 42415 Korea, Republic Of, Gyeonggido Cha Bundang Medical Center, Cha UniversitySeongnam-Si, Gyeonggido, Korea, Republic Of, 13496 St. Vincent'S HospitalSuwon, Gyeonggido, Korea, Republic Of, 16247 Korea, Republic Of, Seoul Teugbyeolsi Samsung Medical CenterGangnam-Gu, Seoul Teugbyeolsi, Korea, Republic Of, 06351 Kangbuk Samsung HospitalJongno-Gu, Seoul Teugbyeolsi, Korea, Republic Of, 03181 Severance HospitalSeoul, Seoul Teugbyeolsi, Korea, Republic Of, 03722 Korea, Republic Of Hanyang University Guri HospGuri-Si, Korea, Republic Of, 471-701 Asan Medical CenterSeoul, Korea, Republic Of, 05505|Sakura-Shi, Chiba, Japan, 285-8741|Sapporo, Hokkaido, Japan, 060-0033|Kobe, Hyogo, Japan, 650-0015|Sendai-Shi, Miyagi, Japan, 980-8574 Tohoku Rosai Hospitalä»™å\u008f°å¸‚, Miyagi, Japan, ã€’981-8563|Oita-Shi, Oita, Japan, 870-0823|Otsu, Shiga, Japan, 520-2192|Bunkyo-Ku, Tokyo, Japan, 113-8519 Kyorin University HospitalMitaka-Shi, Tokyo, Japan, 181-8611|Riga, Latvia, 1038 P. Stradins Clinical Univ HospRiga, Latvia, Lv-1002 Veselibas Centrs 4 LtdRiga, Latvia, Lv-1012|Kovno, Kaunas, Lithuania, 50161|Klaipeda, Lithuania, Lt-92288 Vilnius University HospitalVilnius, Lithuania, Lt-08661|Tilburg, Netherlands, 5022 Gc|Amsterdam, Noord-Holland, Netherlands, 1105 Az|Swidnik, Lubelskie, Poland, 21-040|Warsaw, Mazowieckie, Poland, 00-632 Centralny Szpital Kliniczny MsWarsaw, Mazowieckie, Poland, 02-507|Bydgoszcz, Poland, 85-168 Centrum Medyczne PlejadyKrakow, Poland, 30-349 Centrum Onkologii-Instytutu ImWarszawa, Poland, 02-781|Coimbra, Portugal, 3000-075 Centro Hospitalar Do AlgarveFaro, Portugal, 8000-386 Hsog - Hospital Senhora Da OliGuimaraes, Portugal, 4835-044 Centro Hospitalar De Sao Joao, EpePorto, Portugal, 4200-319 Centro Hospitalar De Entre O DSanta Maria Da Feira, Portugal, 4520-211 Centro Hosp De Tondela-ViseuViseu, Portugal, 3504 - 509|Portimao, Faro, Portugal, 8500-338|Almada, Lisboa, Portugal, 2805-267 Centro Hosp De Lisboa CentralLisbon, Lisboa, Portugal, 1169-050|Bucharest, Romania, 22328 Spitalul Clinic Judetean MuresTargu Mures, Romania, 540103 Cabinet Particular Algomed SrlTimisoara, Romania, 300002 Centrul Medical Tuculanu SrlTimisoara, Romania, 300168|Coronado, American|Nis, Nisavski Okrug, Serbia, 18000|Kragujevac, Sumadijski Okrug, Serbia, 34000|Novi Sad, Vojvodina, Serbia, 21000|Banska Bystrica, Slovakia, 97517 Univerzitna Nemocnica MartinMartin, Slovakia, 036 01 Gastro I.S.R.O.Presov, Slovakia, 08001|Johannesburg, Gauteng, South Africa, 2193|Cape Town, Western Cape, South Africa, 7800|Cape Town, South Africa, 7708|Barcelona, Spain, 08028 Hospital Clinic De BarcelonaBarcelona, Spain, 08036 Hospital Universitario Reina SCordoba, Spain, 14004 Hospital Universitario De CabuGijon, Spain, 33394 Hospital General Universitario Gregorio MaranonMadrid, Spain, 28009 Hospital Universitario La PazMadrid, Spain, 28046 Hosp Univ Puerta De HierroMajadahonda, Spain, 28222 Compl Hospital Univer De VigoPontevedra, Spain, 36312 Hospital Clinico Univ De SalamancaSalamanca, Spain, 37007 Hospital Universitario Virgen MacarenaSevilla, Spain, 41009 Hospital De ManisesValencia, Spain, 46940 Hospital Univ Miguel ServetZaragoza, Spain, 50009 Taiwan, Taipei National Taiwan University HospitalTaipei City, Taipei, Taiwan, 100 Taiwan Chung Shan Medical UniversityTaichung City, Taiwan, 40201 Taichung Veterans General HospTaichung City, Taiwan, 40705 Taipei Veterans General HospTaipei City, Taiwan, 11217|Ankara, Turkey, 6100 FÄ±rat University Medical FaculElazig, Turkey, 23100 Istanbul University CerrahpasaIstanbul, Turkey, 34098 Haydarpasa Numune TrainingIstanbul, Turkey, 34668|Osmangazi, Bursa, Turkey, 16080|Kiev, Kyiv, Ukraine, 1030|Kyiv, Ukraine, 01030 Poltava Reg Clin Hosp SklifosoPoltava, Ukraine, 36011|Bath, United Kingdom, Ba1 3Ng Univ Hospitals Birmingham NhsBirmingham, United Kingdom, B15 2Th Addenbrookes HospitalCambridge, United Kingdom, Cb2 0Sp Castle Hill HospitalKingston Upon Hull, United Kingdom, Hu16 5Jq Barts And The London Nhs TrustLondon, United Kingdom, Ec1A 7Be King'S College Hospital NhsLondon, United Kingdom, Se5 9Rs Royal Victoria Infirmary, NewcNewcastle Upon Tyne, United Kingdom, Ne1 4Lp|La Jolla, California, United States, 92037 Cedars-Sinai Medical CtrLos Angeles, California, United States, 90048 Gastrointestinal BiosciencesLos Angeles, California, United States, 90067-2001 Temecula Valley Endoscopy CtrMurrieta, California, United States, 92562 Ucsf Center For Colitis And Crohn'S DiseaseSan Francisco, California, United States, 94115-3011 Univ Of California San FrancisSan Francisco, California, United States, 94158|Colorado Springs, Colorado, United States, 80907|Farmington, Connecticut, United States, 06032 Medical Research Ctr CtHamden, Connecticut, United States, 06518 Ct Childrens Medical Ctr, UsHartford, Connecticut, United States, 06106|Debary, Florida, United States, 32713-2260 Coral Research ClinicMiami, Florida, United States, 33186-4643 Gastroenterology Group NaplesNaples, Florida, United States, 34102 Florida HospitalOrlando, Florida, United States, 32803 Clinical Res Trials Of FloridaTampa, Florida, United States, 33607 Florida Hospital TampaTampa, Florida, United States, 33613-4680|Macon, Georgia, United States, 31201 Atlanta Gastroenterology SpecSuwanee, Georgia, United States, 30024|Chicago, Illinois, United States, 60611-2927 Dm Clinical Research/SouthwestOak Lawn, Illinois, United States, 60453|Kansas City, Kansas, United States, 66160 Cotton-O'Neil Clinical Res CtrTopeka, Kansas, United States, 66606|Baton Rouge, Louisiana, United States, 70809 Houma Digestive Health SpecialHouma, Louisiana, United States, 70360 Nola Research Works, LlcNew Orleans, Louisiana, United States, 70115 Louisiana Research Ctr. LlcShreveport, Louisiana, United States, 71105|Boston, Massachusetts, United States, 02114|Rochester, Minnesota, United States, 55905-0001|Las Vegas, Nevada, United States, 89109 Comprehensive Digestive InstitLas Vegas, Nevada, United States, 89113|New York, New York, United States, 10032 Digiovanna Institute For MedicNorth Massapequa, New York, United States, 11758|Chapel Hill, North Carolina, United States, 27514 Charlotte Gastro HepatologyCharlotte, North Carolina, United States, 28207 Kinston Medical Specialists PaKinston, North Carolina, United States, 28501-1589|Fargo, North Dakota, United States, 58104-5925|Oklahoma City, Oklahoma, United States, 73112|Philadelphia, Pennsylvania, United States, 19104-5502 Allegheny General HospitalPittsburgh, Pennsylvania, United States, 15212|Germantown, Tennessee, United States, 38138 East Tennessee Research InstitJohnson City, Tennessee, United States, 37604 Vanderbilt University Medical CenterNashville, Tennessee, United States, 37232-0011|Baytown, Texas, United States, 77521-2415 Aztec Clinical Research, Inc.Channelview, Texas, United States, 77530 Baylor College Of MedicineHouston, Texas, United States, 77030-2608 Precision Research Institute - HoustonHouston, Texas, United States, 77036 Centex Studies Inc.Houston, Texas, United States, 77058-2705 Dcol Ctr For Clinical ResearchLongview, Texas, United States, 75605 Clinical Associates In ResearcSan Antonio, Texas, United States, 78212 Sagact PllcSan Antonio, Texas, United States, 78229 Tyler Research Institute, LlcTyler, Texas, United States, 75701 Victoria GastroenterologyVictoria, Texas, United States, 77904|Bountiful, Utah, United States, 84010 Advanced Research InstituteOgden, Utah, United States, 84405-6779|Norfolk, Virginia, United States, 23502|Seattle, Washington, United States, 98101 University Of WashingtonSeattle, Washington, United States, 98109 American","California|Colorado|Connecticut|Florida|Georgia|Illinois|Kansas|Louisiana|Massachusetts|Minnesota|Nevada|New York|North Carolina|North Dakota|Oklahoma|Pennsylvania|Tennessee|Texas|Utah|Virginia|Washington","Argentina|Austria|Belgium|Brazil|Bulgaria|Chile|Croatia|Czechia|Denmark|France|Germany|Greece|Hungary|Israel|Italy|Japan|Latvia|Lithuania|Netherlands|Poland|Portugal|Romania|Samoa|Serbia|Slovakia|South Africa|Spain|Turkey|Ukraine|United Kingdom|United States","Cemic|Lkh-Univ. Klinikum Graz|Niederosterreich UniversitÃ¤tsklinikum St.PÃ¶lten|Wein Medical University Of Vienna|Bruxelles-Capitale Cub Hospital Erasme|Liege Chu LiÃ¨ge Sart Tilman|Oost-Vlaanderen Uz Ghent|Uz Brussels|Goias Instituto Goiano De Gastroente|Parana Hospital Nossa Senhora Das Gra|Rio Grande Do Sul Hospital De Clinicas De Porto Alegre|Sao Paulo Upeclin Fmb - Unesp|Umhat \"Kaspela\" Eood|Investigaciones Medicas Ssmso|Grad Zagreb Klinicka Bolnica Dubrava|Klinicki Bolnicki Centar Split|Osjecko-Baranjska Zupanija Klinicki Bolnicki Centar Osijek|Hepato-Gastro Hk, S.R.O.|Olomoucky Kraj Ctcenter Mave, S.R.O.|Praha 5 Axon Clinical, S.R.O.|Midtjylland Aarhus University Hospital|SjÃ¦lland Sjaellands Universitets Hospit|Svendborg Sygehus, Sygehusenhe|Gironde HÃ´pital Haut-LÃ©vÃªque|Drk Kliniken Berlin|Nordrhein-Westfalen Uniklinik Koln|Gen Hosp Chest Athens Sotiria|Kenezy Gyula Korhaz Es Rendelo|Soroka Medical Center|Tel-Aviv Rabin Medical Center|Calabria UniversitÃ  Di Catanzaro \"Magna Graecia\"|Emilia-Romagna Ospedale Sant Orsola Malpighi|Irccs Aou San Martino-Ist|Lazio Policlinico Universitario Campus Bio-Medico|Lombardia Istituto Clinico Humanitas|Sicilia A.O. Per L'Emergenza Cannizzaro|Verona Ospedale Classificato Equiparato Sacro Cuore-Don Calabria|Aichi Nagoya City University Hospital|Asahikawa Medical Univ Hosp|Chiba Toho University Sakura Medical Center|Hokkaido Hokkaido Sapporo-Kosei Gen Hos|Hyogo Aoyama Clinic|Miyagi Tohoku University Hospital|Oita Ishida Clinic Of Ibd And Gastroenterology|Shiga Shiga Univ Med Science Hosp|Tokyo Medical Hospital Of Tokyo Medical And Dental University|Riga East Clinical Univ Hosp|Kaunas Hospital Of Lithuanian Univers|Klaipeda Seamens Hospital|Elisabeth Tweesteden Ziekenhui|Noord-Holland Academisch Medisch Centrum|Lubelskie Lubelskie Centrum Diagnostyczne|Mazowieckie Centrum Zdrowia Matki Dziecka|Szpital Uni Nr 2 Im Dr Biziela|Chuc- Centro Hospitalar E Univ|Faro Centro Hospitalar Do Algarve - Hospital De PortimÃ£o|Lisboa Hospital Garcia De Orta E.P.E|Institutul Clinic Fundeni|Southern California Res. Ctr.|Nisavski Okrug Clinical Center Of Nis|Sumadijski Okrug Clinical Center Kragujevac|Vojvodina Clinical Center Vojvodina|Fn S Poliklinikou F.D. Rooseve|, Gauteng Wits Clinical Research Site Area 554|, Western Cape Mediclinic Constantiaberg|Dr Jp Wright|Hospital Universitario Parc Tauli|Ankara Univ Medical Faculty|Bursa UludaÄŸ Ãœniversitesi AtatÃ¼rk Rehabilitasyon Uygulama Ve AraÅŸtÄ±rma Merkezi|Kyiv Kyiv Municipal Clinical Hospital #18|Kyiv Municipal Clinical Hospit|Royal United Hospitals Bath|Ucsd|Peak Gastroenterology Associat|Connecticut Gi|Omega Research Consultants, Llc|Gastro Assoc Of Central Ga|Northwestern University|Univ Kansas Med Ctr|Gastroenterology Assoc. La|Mgh Digestive Health Center|Mayo Clinic|Pediatric Gastro & Nutr Assoc|Columbia University Medical Center-Ob/Gyn Department|Unc Health Care|Plains Clinical Research Center, Llc|Digestive Disease Specialists|University Of Pennsylvannia|Gastro One|Inquest Clinical Research|Val R. Hansen|Digestive And Liver Disease Sp|Virginia Mason Medical Center",{"$nulls":3},"AbbVie Inc.","2018-03-08","2020-05-25T16:36:34.048","2020-05-26T17:10:42.972","NCT03398148"]
["5ecbf411fe30261b1a04823c","NCT03398148","2018-04-26","AbbVie","ABBV","Recruiting","A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy","Risankizumab","IL23 Inhibitor","Yes","['Risankizumab']","No",null,"Phase 2/Phase 3",16,720,"Anticipated","2018-03-07","2020-09-23",{"$nulls":5},"The objectives of Sub-Study 1 are to evaluate the efficacy, safety, and pharmacokinetics of risankizumab as induction treatment in subjects with moderately to severely active ulcerative colitis (UC), and to identify the appropriate induction dose of risankizumab for further evaluation in Sub-Study 2.\n\nThe objective of Sub-Study 2 is to evaluate the efficacy and safety of risankizumab compared to placebo in inducing clinical remission in subjects with moderately to severely active UC.",null,"A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy","M16-067","Ulcerative Colitis","Colitis|Colitis, Ulcerative","Gastrointestinal Diseases","Gastrointestinal","Experimental|Placebo Comparator","Substudy 1, Induction 2: Double-blind Risankizumab Dose 2|Substudy 2, Induction 1: Open-label Risankizumab Dose 2|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 2, Induction 2: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 2, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 3|Substudy 2, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 1, Induction 1: Open-label Risankizumab Dose 3","Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection in Induction 2.|Participants randomized to receive risankizumab dose 2 administered by intravenous (IV) infusion.|Participants who received placebo with inadequate response in Induction 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.|Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 3 administered by subcutaneous (SC) injection in Induction 2.|Participants randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion.|Participants who received placebo with inadequate response in Induction 1 receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.|Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.|Participants randomized to receive risankizumab dose 3 administered by intravenous (IV) infusion.|Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.|Participants receive risankizumab dose 3 administered by intravenous (IV) infusion.","Drug","rizankizumab SC|risankizumab IV|placebo for rizankizumab","rizankizumab subcutaneous (SC) injection|rizankizumab intravenous (IV) infusion|placebo for rizankizumab","ABBV-066 | BI 655066","Substudy 1, Induction 2: Double-blind Risankizumab Dose 2|Substudy 2, Induction 1: Open-label Risankizumab Dose 2|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 2, Induction 2: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 2, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 3|Substudy 2, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 1, Induction 1: Open-label Risankizumab Dose 3","\n\n * Male or female aged >=18 to <= 80 years at the Baseline Visit. Where locally permissible, subjects 16 to < 18 years of age who meet the definition of Tanner stage 5 for development at the Baseline Visit\n * Confirmed diagnosis of ulcerative colitis (UC) for at least 3 months prior to Baseline.\n * Active UC as assessed by adapted Mayo Score\n * Demonstrated intolerance or inadequate response to one or more biologic therapies\n * Females must be postmenopausal for more than 2 years or surgically sterile or practicing specific forms of birth control.\n\n","\n\n * Subject with a current diagnosis of Crohn's disease (CD), inflammatory bowel disease-unclassified (IBD-U) or a history of radiation colitis or ischemic colitis.\n * Subject receiving prohibited medications and treatment.\n * Extent of inflammatory disease limited to the rectum as assessed by screening endoscopy.\n * Subject with currently known complications of UC (e.g., megacolon).",{"$nulls":4},"Actual","2018-01-12","Actual","Anticipated","2021-12-25","Anticipated","2018-04-01","2018-01-08","2018-01-08","2018-04-24","Yes","ABBV-066\nBI 655066","Interventional","Treatment","Parallel Assignment","Double (Participant, Investigator)","Randomized","16 Years","80 Years","All",null,"No","Undecided",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2016-004677-40","EudraCT Number","Percentage of participants with clinical remission per adapted Mayo Score at Week 12","Clinical remission per adapted Mayo Score.","Week 12","Percentage of participants achieving clinical remission per full Mayo Score at Week 12 in subjects with a full Mayo score of 6 to 12 at Baseline|Ulcerative Colititis Symptom Questionnaire (UC-SQ): Change from Baseline to Week 12|Inflammatory Bowel Disease Questionnaire (IBDQ): Change from Baseline to Week 12|Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue): Change from Baseline to Week 12|Percentage of participants achieving clinical response per adapted Mayo Score at week 12|Percentage of participants with endoscopic remission at Week 12|Percentage of participants achieving clinical response per partial adapted Mayo Score at week 4|Percentage of participants with mucosal healing at Week 12|36-Item Short Form Health Status Survey (SF-36): Change from Baseline to Week 12|Percentage of participants with hospitalization through Week 12|Percentage of participants with Ulcerative Colitis (UC)-related surgeries through Week 12|Percentage of participants with endoscopic improvement at Week 12","Clinical remission per full Mayo Score.|The US-SQ is a patient questionnaire to assess severity of Crohn's symptoms.|The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.|The FACIT-Fatigue is a validated tool that measures an individual's level of fatigue during their usual daily activities over the past week.|Clinical response per adapted Mayo Score.|Endoscopic remission per endoscopy subscore.|Clinical response per partial adapted Mayo Score (without endoscopy).|Mucosal healing defined as endoscopic and histologic remission.|The SF-36 is an indicator of overall health status.|Participants with an event that results in admission to the hospital.|Participants who underwent surgery related to UC.|Endoscopic improvement per endoscopy subscore.","Week 12|Baseline, Week 12|Week 4|12 weeks","abbvieclinicaltrials@abbvie.com","ABBVIE CALL CENTER","847.283.8955","Buenos Aires, Argentina, 1431 Hosp Privado Ctr Med CordobaCordoba, Argentina, 5016 Sanatorio GuemesCuidad Autonoma De Buenosaires, Argentina, C1180Aad Instituto Medico CerQuilmes, Argentina, 1878 Sanatorio 9 De Julio S.A.San Miguel De Tucuman, Argentina, 4000 Hopital CentenarioSanta Fe, Argentina, 2000|Graz, Austria, 8036 Lkh Salzburg And ParacelsusSalzburg, Austria, 5020|St. PÃ¶lten, Niederosterreich, Austria, 3100|Vienna, Wein, Austria, 1090|Brussels, Bruxelles-Capitale, Belgium, 1070 Cliniques Universitaires Saint LucWoluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200|Liege, Liege, Belgium, 4000|Gent, Oost-Vlaanderen, Belgium, 9000|Jette, Brussels, Belgium, 1090 Uz LeuvenLeuven, Belgium, 3000 Clinique St JosephLiege, Belgium, 4000 Az-DeltaRoeselare, Belgium, 8800 Chu Dinant Godinne - Ucl NamurYvoir, Belgium, 5530|Goiania, Goias, Brazil, 74535-170|Curitiba, Parana, Brazil, 80810-040|Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903|Botucatu, Sao Paulo, Brazil, 18618-686 Hospital Das Clinicas Da Faculdade De Medicina De RibeirÃ£o Preto - UspRibeirÃ£o Preto, Sao Paulo, Brazil, 14048-900 Faculdade De Medicina Do AbcSanto AndrÃ©, Sao Paulo, Brazil, 09060-870 Kaiser Clinica E Hospital DiaSao Jose Do Rio Preto, Sao Paulo, Brazil, 15015-110|Plovdiv, Bulgaria, 4001 Ii Mhat - SofiaSofia, Bulgaria, 1202 Acibadem City Clinic TokudaSofia, Bulgaria, 1407|Calgary, Alberta, Canada, T2N 4Z6 South Edmonton GastroenterologEdmonton, Alberta, Canada, T6L 6K3|New Westminster, British Columbia, Canada, V3L 3W4 Gi Research InstituteVancouver, British Columbia, Canada, V6Z 2K5 Percuro ClinicVictoria, British Columbia, Canada, V8R6R3|Santiago, Chile, 8207257 Hospital Clinico UniversidadSantiago, Chile, 8380456 Hospital Las HiguerasTalcahuano, Chile|Zagreb, Grad Zagreb, Croatia, 10000 Klinicki Bolnicki Centar ZagrebZagreb, Grad Zagreb, Croatia, 10000|Split, Croatia, 21000|Osijek, Osjecko-Baranjska Zupanija, Croatia, 31000|Hradec Kralove, Czechia, 500 12 Nemocnice Pardubickeho Kraje,Pardubice, Czechia, 53203|Olomouc, Olomoucky Kraj, Czechia, 779 00|Praha, Praha 5, Czechia, 150 00|Hvidovre, Denmark, 2650|Aarhus C, Midtjylland, Denmark, 8000|Roskilde, SjÃ¦lland, Denmark, 4000|Nyborg, Syddanmark, Denmark, 5800|Alexandria, Egypt, 21131 Nat Hep & Trop Med Res InstCairo, Egypt, 1141 Air Force Specialized HospitalCairo, Egypt|Pessac Cedex, Gironde, France, 33604|Berlin, Germany, 14050 Praxis Fuer GastroenterologieHeidelberg, Germany, 69121|KÃ¶ln, Nordrhein-Westfalen, Germany, 50937|Ulm, Thuringen, Germany, 89081|Athens, Greece, 11527 General Uh Of HeraklionHeraklion, Greece, 71110 Agios Panteleimon General HospPireaus, Greece, 18454 Theageneio Cancer HospitalThessaloniki, Greece, 546 39|GyÃ¶ngyÃ¶s, Heves, Hungary, 3200|Debrecen, Hungary, 4031 Miskolci Semmelweis Korhaz EsKecskemet, Hungary, 6000 Tolna Megyei Onkormanyzat BalaSzekszÃ¡rd, Hungary, 7100|Be'Er Sheva, Israel, 85025 Rambam Medical CenterHaifa, Israel, 3525408 Shaare Zedek Medical CenterJerusalem, Israel, 91031 Hadassah Ein Kerem Medical CtrJerusalem, Israel, 91120 Sheba Medical CenterRamat Gan, Israel, 5262100|Petakh Tikva, Tel-Aviv, Israel, 4941492|Catanzaro, Calabria, Italy, 88100|Bologna, Emilia-Romagna, Italy, 40138|Genoa, Italy, 16132 Azienda Ospedaliera Ospedale NMilano, Italy, 20162 Azienda Ospedaliera Luigi SaccMilan, Italy, 20157 Policlinico Tor VergataRome, Italy, 00133 Uoc Medicina Interna E GastroeRome, Italy, 168|Rome, Lazio, Italy, 00128 A.O. San Camillo-ForlaniniRome, Lazio, Italy, 00152 Azienda Policlinico Universitario Umberto IRome, Lazio, Italy, 00161|Rozzano, Milano, Italy, 20089|Catania, Sicilia, Italy, 95126|Negrar, Verona, Italy, 37024|Nagakute, Aichi, Japan, 4801195 Nagoya University HospitalNagoya-Shi, Aichi, Japan, 466-8560 Nagoya City University HospitalNagoya-Shi, Aichi, Japan, 467-8602|Asahikawa-Shi, Japan, 078-8510 Hiroshima University HospitalHiroshima, Japan, 734-8551 Ofuna Chuo HospitalKamakura, Japan The Jikei University HospitalMinato-Ku, Japan, 105-8471 Kitasato University Kitasato IMinato-Ku, Japan, 108-8642 Kitasato University HospitalSagamihara-Shi, Japan, 252-0375 Kyoto University HospitalSakyo-Ku, Japan, 606-8507 Nho Shizuoka Medical CenterShimizu-Sho, Japan Fujita Health University HospToyoake, Japan, 470-1192 Jp Red Cross Wakayama Med CtrWakayama, Japan Yokkaichi Hazu Medical CenterYokkaichi-Shi, Japan, 510-0016 Korea, Republic Of, Busan Gwang Yeogsi Dong-A University HospitalBusan, Busan Gwang Yeogsi, Korea, Republic Of, 49201 Pusan National University HospBusan, Busan Gwang Yeogsi, Korea, Republic Of, 602-739 Korea, Republic Of, Daegu Gwang Yeogsi Yeungnam University Med CtrDaegu, Daegu Gwang Yeogsi, Korea, Republic Of, 42415 Korea, Republic Of, Gyeonggido Cha Bundang Medical Center, Cha UniversitySeongnam-Si, Gyeonggido, Korea, Republic Of, 13496 St. Vincent'S HospitalSuwon, Gyeonggido, Korea, Republic Of, 16247 Korea, Republic Of, Seoul Teugbyeolsi Samsung Medical CenterGangnam-Gu, Seoul Teugbyeolsi, Korea, Republic Of, 06351 Kangbuk Samsung HospitalJongno-Gu, Seoul Teugbyeolsi, Korea, Republic Of, 03181 Severance HospitalSeoul, Seoul Teugbyeolsi, Korea, Republic Of, 03722 Korea, Republic Of Haeundae Paik HospitalBusan, Korea, Republic Of, 48108 Hanyang University Guri HospGuri-Si, Korea, Republic Of, 471-701|Sakura-Shi, Chiba, Japan, 285-8741|Kurume-Shi, Fukuoka, Japan, 830-0011|Takasaki-Shi, Gunma, Japan, 370-0829|Fukuyama-Shi, Hiroshima, Japan, 720-8520|Sapporo-Shi, Hokkaido, Japan, 060-8543 Hokkaido Sapporo-Kosei Gen HosSapporo, Hokkaido, Japan, 060-0033|Kobe, Hyogo, Japan, 650-0015|Kanazawa, Ishikawa, Japan, 92086-41|Sendai-Shi, Miyagi, Japan, 980-8574 Tohoku Rosai HospitalSendai-Shi, Miyagi, Japan, 981-8563|Saitama-Shi, Saitama, Japan, 336-0963|Otsu, Shiga, Japan, 520-2192|Bunkyo-Ku, Tokyo, Japan, 113-8519 Kyorin University HospitalMitaka-Shi, Tokyo, Japan, 181-8611|Yamagata-Shi, Yamagata, Japan, 990-9585|Riga, Latvia, 1038 P. Stradins Clinical Univ HospRiga, Latvia, Lv-1002 Veselibas Centrs 4 LtdRiga, Latvia, Lv-1012|Kovno, Kaunas, Lithuania, 50161|Klaipeda, Lithuania, Lt-92288 Vilnius University HospitalVilnius, Lithuania, Lt-08661|Tilburg, Netherlands, 5022 Gc|Amsterdam, Noord-Holland, Netherlands, 1105 Az|Bydgoszcz, Kujawsko-Pomorskie, Poland, 85-168|Swidnik, Lubelskie, Poland, 21-040|Krakow, Malopolskie, Poland, 30-363|Warszawa, Mazowieckie, Poland, 01-783 Centralny Szpital Kliniczny Mswia W WarszawieWarszawa, Mazowieckie, Poland, 02-507 Centrum Onkologii-Instytut Im.M.Sklodowskiej-Curie W WarszawieWarszawa, Mazowieckie, Poland, 02-781|Coimbra, Portugal, 3000-075 Hsog - Hospital Senhora Da OliGuimaraes, Portugal, 4835-044 Centro Hospitalar De Sao Joao, EpePorto, Portugal, 4200-319 Centro Hospitalar De Entre O DSanta Maria Da Feira, Portugal, 4520-211 Centro Hosp De Tondela-ViseuViseu, Portugal, 3504 - 509|Portimao, Faro, Portugal, 8500-338|Almada, Lisboa, Portugal, 2805-267 Centro Hosp De Lisboa CentralLisbon, Lisboa, Portugal, 1169-050|Bucharest, Romania, 22328 Spitalul Clinic Judetean MuresTargu Mures, Romania, 540103 Cabinet Particular Algomed SrlTimisoara, Romania, 300002 Centrul Medical Tuculanu SrlTimisoara, Romania, 300168|Coronado, American|Nis, Nisavski Okrug, Serbia, 18000|Kragujevac, Sumadijski Okrug, Serbia, 34000|Novi Sad, Vojvodina, Serbia, 21000|Banska Bystrica, Slovakia, 97517 Gastro I.S.R.O.Presov, Slovakia, 08001|Martin, Trnavsky Kraj, Slovakia, 036 01|Johannesburg, Gauteng, South Africa, 2193|Cape Town, Western Cape, South Africa, 7800|Cape Town, South Africa, 7708|Barcelona, Spain, 08028 Hospital Clinic De BarcelonaBarcelona, Spain, 08036 Hospital Universitario Reina SCordoba, Spain, 14004 Hospital Universitario De CabuGijon, Spain, 33394 Hospital General Universitario Gregorio MaranonMadrid, Spain, 28009 Hospital Universitario La PazMadrid, Spain, 28046 Hosp Univ Puerta De HierroMajadahonda, Spain, 28222 Compl Hospital Univer De VigoPontevedra, Spain, 36312 Hospital Clinico Univ De SalamancaSalamanca, Spain, 37007 Hospital Universitario Virgen MacarenaSevilla, Spain, 41009 Hospital De ManisesValencia, Spain, 46940 Hospital Univ Miguel ServetZaragoza, Spain, 50009|Stockholm, Sweden, 182 88 Taiwan, Taipei National Taiwan University HospitalTaipei City, Taipei, Taiwan, 100 Taiwan Chung Shan Medical UniversityTaichung City, Taiwan, 40201 Taichung Veterans General HospTaichung City, Taiwan, 40705 Taipei Veterans General HospTaipei City, Taiwan, 11217|AlingsÃ¥s, Vastra Gotalands Lan, Sweden, 441 33|Ankara, Turkey, 6100 FÄ±rat University Medical FaculElazig, Turkey, 23100 Istanbul University CerrahpasaIstanbul, Turkey, 34098 Haydarpasa Numune TrainingIstanbul, Turkey, 34668|Osmangazi, Bursa, Turkey, 16080|Kharkov, Ukraine, 61058 Kiev Regional Clinical HospKiev, Ukraine, 04107 Kyiv Municipal Clinical HospitKyiv, Ukraine, 01030|Bath, United Kingdom, Ba1 3Ng Univ Hospitals Birmingham Nhs Foundation TrustBirmingham, United Kingdom, B15 2Tg Addenbrookes HospitalCambridge, United Kingdom, Cb2 0Sp Castle Hill HospitalKingston Upon Hull, United Kingdom, Hu16 5Jq Barts And The London Nhs TrustLondon, United Kingdom, Ec1A 7Be King'S College Hospital NhsLondon, United Kingdom, Se5 9Rs Royal Victoria Infirmary, NewcNewcastle Upon Tyne, United Kingdom, Ne1 4Lp|La Jolla, California, United States, 92037 Cedars-Sinai Medical CtrLos Angeles, California, United States, 90048 Gastrointestinal BiosciencesLos Angeles, California, United States, 90067-2001 United GastroenterologistsMurrieta, California, United States, 92563 Ucsf Center For Colitis And Crohn'S DiseaseSan Francisco, California, United States, 94115-3011 Univ Of California San FrancisSan Francisco, California, United States, 94158|Colorado Springs, Colorado, United States, 80907|Farmington, Connecticut, United States, 06032 Medical Research Ctr CtHamden, Connecticut, United States, 06518 Ct Childrens Medical Ctr, UsHartford, Connecticut, United States, 06106|Clermont, Florida, United States, 34711 Ctr For Advanced GastroenterolMaitland, Florida, United States, 32751-6108 Coral Research ClinicMiami, Florida, United States, 33186-4643 Gastroenterology Group NaplesNaples, Florida, United States, 34102 Omega Research MaitlandOrlando, Florida, United States, 32810 Clinical Research Trials Of Florida, Inc.Tampa, Florida, United States, 33607 Florida Hospital TampaTampa, Florida, United States, 33613-4680|Atlanta, Georgia, United States, 30322 Gastro Assoc Of Central GaMacon, Georgia, United States, 31201 Atlanta Gastroenterology SpecSuwanee, Georgia, United States, 30024|Chicago, Illinois, United States, 60611-2927 University Of ChicagoChicago, Illinois, United States, 60637-1443 Dm Clinical Research/SouthwestOak Lawn, Illinois, United States, 60453|Kansas City, Kansas, United States, 66160 Cotton-O'Neil Clinical Res CtrTopeka, Kansas, United States, 66606|Baton Rouge, Louisiana, United States, 70809 Houma Digestive Health SpecialHouma, Louisiana, United States, 70360 Nola Research Works, LlcNew Orleans, Louisiana, United States, 70115 Louisiana Research Ctr. LlcShreveport, Louisiana, United States, 71105-6800|Boston, Massachusetts, United States, 02114 Children'S Hospital BostonBoston, Massachusetts, United States, 02115|Troy, Michigan, United States, 48098-6363|Rochester, Minnesota, United States, 55905-0001|Omaha, Nebraska, United States, 68114|Las Vegas, Nevada, United States, 89109 Comprehensive Digestive InstitLas Vegas, Nevada, United States, 89113|New York, New York, United States, 10032-3725 Lenox Hill Hospital, NorthwellNew York, New York, United States, 10075 Digiovanna Institute For MedicNorth Massapequa, New York, United States, 11758 Univ Rochester Med CtrRochester, New York, United States, 14642|Chapel Hill, North Carolina, United States, 27514 Charlotte Gastro HepatologyCharlotte, North Carolina, United States, 28207 Kinston Medical Specialists PaKinston, North Carolina, United States, 28501-1589|Fargo, North Dakota, United States, 58104-5925|Columbus, Ohio, United States, 43210 Optimed Research, Ltd.Columbus, Ohio, United States, 43235 Great Lakes Gastroenterology Research LlcMentor, Ohio, United States, 44060-6211|Oklahoma City, Oklahoma, United States, 73112|Philadelphia, Pennsylvania, United States, 19104-5502 Allegheny General HospitalPittsburgh, Pennsylvania, United States, 15212|Germantown, Tennessee, United States, 38138 East Tennessee Research InstitJohnson City, Tennessee, United States, 37604 Vanderbilt Univ Med CtrNashville, Tennessee, United States, 37232-0011|Baytown, Texas, United States, 77521-2415 Aztec Clinical Research, Inc.Channelview, Texas, United States, 77530 Baylor College Of MedicineHouston, Texas, United States, 77030-2608 Precision Research Institute - HoustonHouston, Texas, United States, 77036 Centex Studies, Inc. - HoustonHouston, Texas, United States, 77062 Dcol Ctr For Clinical ResearchLongview, Texas, United States, 75605 Clinical Associates In ResearcSan Antonio, Texas, United States, 78212 Sagact PllcSan Antonio, Texas, United States, 78229 Tyler Research Institute, LlcTyler, Texas, United States, 75701 Victoria GastroenterologyVictoria, Texas, United States, 77904|Bountiful, Utah, United States, 84010 Advanced Research InstituteOgden, Utah, United States, 84405-6779|Norfolk, Virginia, United States, 23502|Seattle, Washington, United States, 98101 University Of WashingtonSeattle, Washington, United States, 98109 American","California|Colorado|Connecticut|Florida|Georgia|Illinois|Kansas|Louisiana|Massachusetts|Michigan|Minnesota|Nebraska|Nevada|New York|North Carolina|North Dakota|Ohio|Oklahoma|Pennsylvania|Tennessee|Texas|Utah|Virginia|Washington","Argentina|Austria|Belgium|Brazil|Bulgaria|Canada|Chile|Croatia|Czechia|Denmark|Egypt|France|Germany|Greece|Hungary|Israel|Italy|Japan|Latvia|Lithuania|Netherlands|Poland|Portugal|Romania|Samoa|Serbia|Slovakia|South Africa|Spain|Sweden|Turkey|Ukraine|United Kingdom|United States","Cemic|Lkh-Univ. Klinikum Graz|Niederosterreich UniversitÃ¤tsklinikum St.PÃ¶lten|Wein Akh Wien|Bruxelles-Capitale Cub Hospital Erasme|Liege Chu De Liege|Oost-Vlaanderen Uz Gent|Uz Brussels|Goias Instituto Goiano De Gastroente|Parana Hospital Nossa Senhora Das Gra|Rio Grande Do Sul Hospital De Clinicas De Porto Alegre|Sao Paulo Upeclin Fmb - Unesp|Umhat \"Kaspela\" Eood|Alberta University Of Calgary|British Columbia Fraser Clinical Trials Inc|Investigaciones Medicas Ssmso|Grad Zagreb Klinicka Bolnica Dubrava|Klinicki Bolnicki Centar Split|Osjecko-Baranjska Zupanija Klinicki Bolnicki Centar Osijek|Hepato-Gastro Hk, S.R.O.|Olomoucky Kraj Ctcenter Mave, S.R.O.|Praha 5 Axon Clinical, S.R.O.|Hvidovre Hospital|Midtjylland Aarhus University Hospital|SjÃ¦lland Sjaellands Universitets Hospit|Syddanmark Svendborg Sygehus, Sygehusenhe|University Of Alexandria|Gironde HÃ´pital Haut-LÃ©vÃªque|Drk Kliniken Berlin|Nordrhein-Westfalen Uniklinik Koln|Thuringen Universitaetsklinikum Ulm|Gen Hosp Chest Athens Sotiria|Heves Bugat Pal Korhaz|Kenezy Gyula Korhaz Es Rendelo|Soroka Medical Center|Tel-Aviv Rabin Medical Center|Calabria UniversitÃ  Di Catanzaro \"Magna Graecia\"|Emilia-Romagna Ospedale Sant Orsola Malpighi|Irccs Aou San Martino-Ist|Lazio Policlinico Universitario Campus Bio-Medico|Milano Istituto Clinico Humanitas|Sicilia A.O. Per L'Emergenza Cannizzaro|Verona Ospedale Classificato Equiparato Sacro Cuore-Don Calabria|Aichi Aichi Medical University Hosp|Asahikawa Medical Univ Hosp|Chiba Toho University Sakura Med Ctr|Fukuoka Kurume University Hospital|Gunma National Hospital Organization Takasaki General Medical Center|Hiroshima Nho Fukuyama Medical Center|Hokkaido Sapporo Medical Univ Hosp|Hyogo Aoyama Clinic|Ishikawa Kanazawa University Ho|Miyagi Tohoku University Hospital|Saitama Tokito Clinic|Shiga Shiga Univ Med Science Hosp|Tokyo Medical Hospital Of Tokyo Medical And Dental University|Yamagata Yamagata University Hospital|Riga East Clinical Univ Hosp|Kaunas Hospital Of Lithuanian Univers|Klaipeda Seamens Hospital|Elisabeth Tweesteden Ziekenhui|Noord-Holland Academisch Medisch Centrum|Kujawsko-Pomorskie Szpital Uniwersytecki Nr 2 Im. Dr J.Biziela W Bydgoszczy|Lubelskie Lubelskie Centrum Diagnostyczne|Malopolskie Centrum Medyczne Plejady|Mazowieckie Centrum Zdrowia Matki, Dziecka I Mlodziezy|Chuc- Centro Hospitalar E Univ|Faro Centro Hospitalar Do Algarve - Hospital De PortimÃ£o|Lisboa Hospital Garcia De Orta, E.P.E|Institutul Clinic Fundeni|Southern California Res. Ctr.|Nisavski Okrug Clinical Center Of Nis|Sumadijski Okrug Clinical Center Kragujevac|Vojvodina Clinical Center Vojvodina|Fn S Poliklinikou F.D. Rooseve|Trnavsky Kraj Univerzitna Nemocnica Martin|, Gauteng Wits Clinical Research Site|, Western Cape Mediclinic Constantiaberg|Dr Jp Wright|Hospital Universitario Parc Tauli|Danderyds Sjukhus Ab|Vastra Gotalands Lan AlingsÃ¥s Lasarett|Ankara Univ Medical Faculty|Bursa UludaÄŸ Ãœniversitesi AtatÃ¼rk Rehabilitasyon Uygulama Ve AraÅŸtÄ±rma Merkezi|Regional Clinical Hospital|Royal United Hospitals Bath|Ucsd|Peak Gastroenterology Associat|Connecticut Gi|South Lake Pain Institute, Inc|Emory University Hospital|Northwestern University|Univ Kansas Med Ctr|Gastroenterology Assoc. La|Mgh Digestive Health Center|Center For Digestive Health|Mayo Clinic|Quality Clinical Research Inc.|Pediatric Gastro & Nutr Assoc|Columbia Univ Medical Center|Unc Health Care|Plains Clinical Research Center, Llc|The Ohio State University|Digestive Disease Specialists|University Of Pennsylvania|Gastro One|Inquest Clinical Research|Val R. Hansen|Digestive And Liver Disease Sp|Virginia Mason Medical Center",{"$nulls":3},"AbbVie Inc.","2018-04-24","2020-05-25T16:36:33.699","2020-05-26T17:10:42.972","NCT03398148"]
["5ecbf412307e3d1b1f8d9ccd","NCT03398148","2018-05-31","AbbVie","ABBV","Recruiting","A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy","Risankizumab","IL23 Inhibitor","Yes","['Risankizumab']","No",null,"Phase 2/Phase 3",16,720,"Anticipated","2018-03-07","2020-09-23",{"$nulls":5},"The objectives of Sub-Study 1 are to evaluate the efficacy, safety, and pharmacokinetics of risankizumab as induction treatment in subjects with moderately to severely active ulcerative colitis (UC), and to identify the appropriate induction dose of risankizumab for further evaluation in Sub-Study 2.\n\nThe objective of Sub-Study 2 is to evaluate the efficacy and safety of risankizumab compared to placebo in inducing clinical remission in subjects with moderately to severely active UC.",null,"A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy","M16-067","Ulcerative Colitis (UC)","Colitis|Colitis, Ulcerative","Gastrointestinal Diseases","Gastrointestinal","Experimental|Placebo Comparator","Substudy 1, Induction 2: Double-blind Risankizumab Dose 2|Substudy 2, Induction 1: Open-label Risankizumab Dose 2|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 2, Induction 2: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 2, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 3|Substudy 2, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 1, Induction 1: Open-label Risankizumab Dose 3","Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection in Induction 2.|Participants randomized to receive risankizumab dose 2 administered by intravenous (IV) infusion.|Participants who received placebo with inadequate response in Induction 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.|Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 3 administered by subcutaneous (SC) injection in Induction 2.|Participants randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion.|Participants who received placebo with inadequate response in Induction 1 receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.|Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.|Participants randomized to receive risankizumab dose 3 administered by intravenous (IV) infusion.|Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.|Participants receive risankizumab dose 3 administered by intravenous (IV) infusion.","Drug","rizankizumab SC|risankizumab IV|placebo for rizankizumab","rizankizumab subcutaneous (SC) injection|rizankizumab intravenous (IV) infusion|placebo for rizankizumab","ABBV-066 | BI 655066","Substudy 1, Induction 2: Double-blind Risankizumab Dose 2|Substudy 2, Induction 1: Open-label Risankizumab Dose 2|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 2, Induction 2: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 2, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 3|Substudy 2, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 1, Induction 1: Open-label Risankizumab Dose 3","\n\n * Male or female aged >=18 to <= 80 years at the Baseline Visit. Where locally permissible, subjects 16 to < 18 years of age who meet the definition of Tanner stage 5 for development at the Baseline Visit\n * Confirmed diagnosis of ulcerative colitis (UC) for at least 3 months prior to Baseline.\n * Active UC as assessed by adapted Mayo Score\n * Demonstrated intolerance or inadequate response to one or more biologic therapies\n * Females must be postmenopausal for more than 2 years or surgically sterile or practicing specific forms of birth control.\n\n","\n\n * Subject with a current diagnosis of Crohn's disease (CD), inflammatory bowel disease-unclassified (IBD-U) or a history of radiation colitis or ischemic colitis.\n * Subject receiving prohibited medications and treatment.\n * Extent of inflammatory disease limited to the rectum as assessed by screening endoscopy.\n * Subject with currently known complications of UC (e.g., megacolon).",{"$nulls":4},"Actual","2018-01-12","Actual","Anticipated","2021-12-25","Anticipated","2018-05-01","2018-01-08","2018-01-08","2018-05-29","Yes","ABBV-066\nBI 655066","Interventional","Treatment","Parallel Assignment","Double (Participant, Investigator)","Randomized","16 Years","80 Years","All",null,"No","Undecided",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2016-004677-40","EudraCT Number","Percentage of participants with clinical remission per adapted Mayo Score at Week 12","Clinical remission per adapted Mayo Score.","Week 12","Percentage of participants achieving clinical remission per full Mayo Score at Week 12 in subjects with a full Mayo score of 6 to 12 at Baseline|Ulcerative Colitis Symptom Questionnaire (UC-SQ): Change from Baseline to Week 12|Inflammatory Bowel Disease Questionnaire (IBDQ): Change from Baseline to Week 12|Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue): Change from Baseline to Week 12|Percentage of participants achieving clinical response per adapted Mayo Score at week 12|Percentage of participants with endoscopic remission at Week 12|Percentage of participants achieving clinical response per partial adapted Mayo Score at week 4|Percentage of participants with mucosal healing at Week 12|36-Item Short Form Health Status Survey (SF-36): Change from Baseline to Week 12|Percentage of participants with hospitalization through Week 12|Percentage of participants with Ulcerative Colitis (UC)-related surgeries through Week 12|Percentage of participants with endoscopic improvement at Week 12","Clinical remission per full Mayo Score.|The US-SQ is a patient questionnaire to assess severity of Crohn's symptoms.|The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.|The FACIT-Fatigue is a validated tool that measures an individual's level of fatigue during their usual daily activities over the past week.|Clinical response per adapted Mayo Score.|Endoscopic remission per endoscopy subscore.|Clinical response per partial adapted Mayo Score (without endoscopy).|Mucosal healing defined as endoscopic and histologic remission.|The SF-36 is an indicator of overall health status.|Participants with an event that results in admission to the hospital.|Participants who underwent surgery related to UC.|Endoscopic improvement per endoscopy subscore.","Week 12|Baseline, Week 12|Week 4|12 weeks","abbvieclinicaltrials@abbvie.com","ABBVIE CALL CENTER","847.283.8955","Buenos Aires, Argentina, 1431 Hosp Privado Ctr Med CordobaCordoba, Argentina, 5016 Sanatorio GuemesCuidad Autonoma De Buenosaires, Argentina, C1180Aad Instituto Medico CerQuilmes, Argentina, 1878 Sanatorio 9 De Julio S.A.San Miguel De Tucuman, Argentina, 4000 Hopital CentenarioSanta Fe, Argentina, 2000|Graz, Austria, 8036 Lkh Salzburg And ParacelsusSalzburg, Austria, 5020|St. PÃ¶lten, Niederosterreich, Austria, 3100|Vienna, Wein, Austria, 1090|Brussels, Bruxelles-Capitale, Belgium, 1070 Cliniques Universitaires Saint LucWoluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200|Liege, Liege, Belgium, 4000|Gent, Oost-Vlaanderen, Belgium, 9000|Jette, Brussels, Belgium, 1090 Uz LeuvenLeuven, Belgium, 3000 Clinique St JosephLiege, Belgium, 4000 Az-DeltaRoeselare, Belgium, 8800 Chu Dinant Godinne - Ucl NamurYvoir, Belgium, 5530|Goiania, Goias, Brazil, 74535-170|Curitiba, Parana, Brazil, 80810-040|Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903|Botucatu, Sao Paulo, Brazil, 18618-686 Hospital Das Clinicas Da Faculdade De Medicina De RibeirÃ£o Preto - UspRibeirÃ£o Preto, Sao Paulo, Brazil, 14048-900 Faculdade De Medicina Do AbcSanto AndrÃ©, Sao Paulo, Brazil, 09060-870 Kaiser Clinica E Hospital DiaSao Jose Do Rio Preto, Sao Paulo, Brazil, 15015-110|Plovdiv, Bulgaria, 4001 Ii Mhat - SofiaSofia, Bulgaria, 1202 Acibadem City Clinic TokudaSofia, Bulgaria, 1407|Calgary, Alberta, Canada, T2N 4Z6 South Edmonton GastroenterologEdmonton, Alberta, Canada, T6L 6K3|New Westminster, British Columbia, Canada, V3L 3W4 Percuro ClinicVictoria, British Columbia, Canada, V8R6R3|Santiago, Chile, 8207257 Hospital Las HiguerasTalcahuano, Chile|Santiago, Region Metropolitana De Santiago, Chile, 8350488 Hospital Clinico UniversidadSantiago, Region Metropolitana De Santiago, Chile, 8380456|ViÃ±a Del Mar, ValparaÃ­so, Chile, 2540488|Bogota, Colombia, 111156 Instituto De ColoproctologiaMedellin, Colombia, 050024 Hospital Universitario San VicMedellin, Colombia, 50010 Hospital Pablo Tobon UribeMedellÃ­n, Colombia|Zagreb, Grad Zagreb, Croatia, 10000 Klinicki Bolnicki Centar ZagrebZagreb, Grad Zagreb, Croatia, 10000|Split, Croatia, 21000|Osijek, Osjecko-Baranjska Zupanija, Croatia, 31000|Hradec Kralove, Czechia, 500 12 Nemocnice Pardubickeho Kraje,Pardubice, Czechia, 53203|Olomouc, Olomoucky Kraj, Czechia, 779 00|Praha, Praha 5, Czechia, 150 00|Roskilde, SjÃ¦lland, Denmark, 4000|Nyborg, Syddanmark, Denmark, 5800|Alexandria, Egypt, 21131 Nat Hep & Trop Med Res InstCairo, Egypt, 1141 Air Force Specialized HospitalCairo, Egypt National Liver InstituteMenoufiya, Egypt, 35111|Nice Cedex 3, Alpes-Maritimes, France, 06202|Amiens Cedex 1, France, 80054|Pessac Cedex, Gironde, France, 33604|Clichy, Ile-De-|St. Priest En Jarez, Loire, France, 42270|Mannheim, Baden-Wuerttemberg, Germany, 68167|Erlangen, Bayern, Germany, 91054|Berlin, Germany, 10117 Gastroenterologie Am BayerischBerlin, Germany, 10825 Drk Kliniken BerlinBerlin, Germany, 14050 Stadtisches Klinikum BraunschwBraunschweig, Germany, 38126 Agaplesion Markus KrankenhausFrankfurt, Germany, 60341 UniversitÃ¤tsklinikum FreiburgFreiburg, Germany, 79106 Asklepios Westklinikum HamburgHamburg, Germany, 22559 Med Hochschule HanoverHannover, Germany, 30625 Praxis Fuer GastroenterologieHeidelberg, Germany, 69121 Gastroenterologie OpernstrasseKassel, Germany, 34117 Klinikum LueneburgLueneburg, Germany, 21339 Gastro GemeinschaftspraxisMinden, Germany, 32423 Klinikum Univ RegensburgRegensburg, Germany, 93042 Universitatsklinikum TubingenTuebingen, Germany, 72076 Gastro-Praxis WiesbadenWiesbaden, Germany, 65189|Munster, Niedersachsen, Germany, 48149|KÃ¶ln, Nordrhein-Westfalen, Germany, 50937|Kiel, Schleswig-Holstein, Germany, 24105|Ulm, Thuringen, Germany, 89081|Athens, Greece, 11527 General Uh Of HeraklionHeraklion, Greece, 71110 Agios Panteleimon General HospPireaus, Greece, 18454 Theageneio Cancer HospitalThessaloniki, Greece, 546 39|GyÃ¶ngyÃ¶s, Heves, Hungary, 3200|Debrecen, Hungary, 4031 Miskolci Semmelweis Korhaz EsKecskemet, Hungary, 6000 Tolna Megyei Onkormanyzat BalaSzekszÃ¡rd, Hungary, 7100|Be'Er Sheva, Hadarom, Israel, 84101|Haifa, Israel, 3525408 Shaare Zedek Medical CenterJerusalem, Israel, 91031 Sheba Medical CenterRamat Gan, Israel, 5262100|Petakh Tikva, Tel-Aviv, Israel, 4941492|Jerusalem, Yerushalayim, Israel, 91120|Catanzaro, Calabria, Italy, 88100|Bologna, Emilia-Romagna, Italy, 40138 Azienda Ospedaliero-Universitaria Policlinico Di ModenaModena, Emilia-Romagna, Italy, 41124|Genoa, Italy, 16132 Azienda Ospedaliera Ospedale NMilano, Italy, 20162 Azienda Ospedaliera Luigi SaccMilan, Italy, 20157 Policlinico Tor VergataRome, Italy, 00133 Uoc Medicina Interna E GastroeRome, Italy, 168|Rome, Lazio, Italy, 00128 A.O. San Camillo-ForlaniniRome, Lazio, Italy, 00152 Azienda Policlinico Universitario Umberto IRome, Lazio, Italy, 00161|Rozzano, Milano, Italy, 20089|Catania, Sicilia, Italy, 95126|Negrar, Verona, Italy, 37024|Nagakute, Aichi, Japan, 4801195 Nagoya University HospitalNagoya-Shi, Aichi, Japan, 466-8560 Nagoya City University HospitalNagoya-Shi, Aichi, Japan, 467-8602|Asahikawa-Shi, Japan, 078-8510 Hiroshima University HospitalHiroshima, Japan, 734-8551 Ofuna Chuo HospitalKamakura, Japan The Jikei University HospitalMinato-Ku, Japan, 105-8471 Kitasato University Kitasato IMinato-Ku, Japan, 108-8642 Kitasato University HospitalSagamihara-Shi, Japan, 252-0375 Kyoto University HospitalSakyo-Ku, Japan, 606-8507 Nho Shizuoka Medical CenterShimizu-Sho, Japan Fujita Health University HospToyoake, Japan, 470-1192 Jp Red Cross Wakayama Med CtrWakayama, Japan Yokkaichi Hazu Medical CenterYokkaichi-Shi, Japan, 510-0016 Korea, Republic Of, Busan Gwang Yeogsi Dong-A University HospitalBusan, Busan Gwang Yeogsi, Korea, Republic Of, 49201 Pusan National University HospBusan, Busan Gwang Yeogsi, Korea, Republic Of, 602-739 Korea, Republic Of, Daegu Gwang Yeogsi Yeungnam University Med CtrDaegu, Daegu Gwang Yeogsi, Korea, Republic Of, 42415 Korea, Republic Of, Gyeonggido Cha Bundang Medical Center, Cha UniversitySeongnam-Si, Gyeonggido, Korea, Republic Of, 13496 St. Vincent'S HospitalSuwon, Gyeonggido, Korea, Republic Of, 16247 Korea, Republic Of, Seoul Teugbyeolsi Kangbuk Samsung HospitalJongno-Gu, Seoul Teugbyeolsi, Korea, Republic Of, 03181 Severance HospitalSeoul, Seoul Teugbyeolsi, Korea, Republic Of, 03722 Samsung Medical CenterSeoul, Seoul Teugbyeolsi, Korea, Republic Of, 06351 Korea, Republic Of Haeundae Paik HospitalBusan, Korea, Republic Of, 48108 Hanyang University Guri HospGuri-Si, Korea, Republic Of, 471-701|Sakura-Shi, Chiba, Japan, 285-8741|Kurume-Shi, Fukuoka, Japan, 830-0011|Takasaki-Shi, Gunma, Japan, 370-0829|Fukuyama-Shi, Hiroshima, Japan, 720-8520|Sapporo-Shi, Hokkaido, Japan, 060-8543 Hokkaido Sapporo-Kosei Gen HosSapporo, Hokkaido, Japan, 060-0033|Kobe, Hyogo, Japan, 650-0015|Kanazawa, Ishikawa, Japan, 92086-41|Sendai-Shi, Miyagi, Japan, 980-8574|Saitama-Shi, Saitama, Japan, 336-0963|Otsu, Shiga, Japan, 520-2192|Bunkyo-Ku, Tokyo, Japan, 113-8519 Kyorin University HospitalMitaka-Shi, Tokyo, Japan, 181-8611|Yamagata-Shi, Yamagata, Japan, 990-9585|Riga, Latvia, 1038 P. Stradins Clinical Univ HospRiga, Latvia, Lv-1002 Veselibas Centrs 4 LtdRiga, Latvia, Lv-1012|Kovno, Kaunas, Lithuania, 50161|Klaipeda, Lithuania, Lt-92288 Vilnius University HospitalVilnius, Lithuania, Lt-08661|Tilburg, Netherlands, 5022 Gc|Amsterdam, Noord-Holland, Netherlands, 1105 Az|Bydgoszcz, Kujawsko-Pomorskie, Poland, 85-168|Swidnik, Lubelskie, Poland, 21-040|Krakow, Malopolskie, Poland, 30-363|Warszawa, Mazowieckie, Poland, 01-783 Centralny Szpital Kliniczny Mswia W WarszawieWarszawa, Mazowieckie, Poland, 02-507 Centrum Onkologii-Instytut Im.M.Sklodowskiej-Curie W WarszawieWarszawa, Mazowieckie, Poland, 02-781|Coimbra, Portugal, 3000-075 Hsog - Hospital Senhora Da OliGuimaraes, Portugal, 4835-044 Centro Hospitalar De Sao Joao, EpePorto, Portugal, 4200-319 Centro Hospitalar De Entre O DSanta Maria Da Feira, Portugal, 4520-211 Centro Hosp De Tondela-ViseuViseu, Portugal, 3504 - 509|Portimao, Faro, Portugal, 8500-338|Almada, Lisboa, Portugal, 2805-267 Centro Hosp De Lisboa CentralLisbon, Lisboa, Portugal, 1169-050|Bucharest, Romania, 22328 Spitalul Clinic Judetean MuresTargu Mures, Romania, 540103 Cabinet Particular Algomed SrlTimisoara, Romania, 300002 Centrul Medical Tuculanu SrlTimisoara, Romania, 300168 Russian Federation, Kaliningradskaya Oblast Immanuel Kant Baltic Federal UniversityKaliningrad, Kaliningradskaya Oblast, Russian Federation, 236016 Russian Federation, Novosibirskaya Oblast Scientific Research Institute Of Physiology And Fundamental MedicineNovosibirsk, Novosibirskaya Oblast, Russian Federation, 630060 Russian Federation Kemerovo Regional HospitalKemerovo, Russian Federation, 650000 Scien Ctr Coloproctology RosmeMoscow, Russian Federation, 123423 Pmi EuromedservicePushkin, Russian Federation, 196603 Tyumen Regional Clinical HospiTyumen, Russian Federation, 625023 Ulyanovsk Regional Clin HospUlyanovsk, Russian Federation, 432018|Coronado, American|Kragujevac, Sumadijski Okrug, Serbia, 34000|Novi Sad, Vojvodina, Serbia, 21000|Banska Bystrica, Slovakia, 97517 Gastro I.S.R.O.Presov, Slovakia, 08001|Martin, Zilinsky Kraj, Slovakia, 036 01|Johannesburg, Gauteng, South Africa, 2193|Cape Town, Western Cape, South Africa, 7800|Cape Town, South Africa, 7708|Barcelona, Spain, 08028 Hospital Clinic De BarcelonaBarcelona, Spain, 08036 Hospital Universitario Reina SCordoba, Spain, 14004 Hospital Universitario De CabuGijon, Spain, 33394 Hospital General Universitario Gregorio MaranonMadrid, Spain, 28009 Hospital Universitario La PazMadrid, Spain, 28046 Hosp Univ Puerta De HierroMajadahonda, Spain, 28222 Compl Hospital Univer De VigoPontevedra, Spain, 36312 Hospital Clinico Univ De SalamancaSalamanca, Spain, 37007 Hospital Universitario Virgen MacarenaSevilla, Spain, 41009 Hospital De ManisesValencia, Spain, 46940 Hospital Univ Miguel ServetZaragoza, Spain, 50009|Molndal, Sweden, 431 80 Danderyds Sjukhus AbStockholm, Sweden, 182 88 Taiwan, Taipei National Taiwan University HospitalTaipei City, Taipei, Taiwan, 100 Taiwan Chung Shan Medical UniversityTaichung City, Taiwan, 40201 Taichung Veterans General HospTaichung City, Taiwan, 40705 Taipei Veterans General HospTaipei City, Taiwan, 11217|AlingsÃ¥s, Vastra Gotalands Lan, Sweden, 441 33|Ankara, Turkey, 6100 Inonu Universitesi Turgut OzalBattalgazi/Malatya, Turkey, 44280 Uludag University Medical FacultyBursa, Turkey, 16059 FÄ±rat University Medical FaculElazig, Turkey, 23100 Istanbul University Cerrahpasa Medical FacultyIstanbul, Turkey, 34098 Sisli Etfal Train & Res HospIstanbul, Turkey, 34371 Haydarpasa Numune TrainingIstanbul, Turkey, 34668 Marmara University Medical FacIstanbul, Turkey, 34899|Melikgazi, Kayseri, Turkey, 38030|Kharkov, Ukraine, 61058 Kyiv Municipal Clinical HospitKyiv, Ukraine, 01030|Barnsley, United Kingdom, S75 2Ep Royal United Hospitals BathBath, United Kingdom, Ba1 3Ng Univ Hospitals Birmingham Nhs Foundation TrustBirmingham, United Kingdom, B15 2Tg Addenbrookes HospitalCambridge, United Kingdom, Cb2 0Sp Castle Hill HospitalKingston Upon Hull, United Kingdom, Hu16 5Jq Barts And The London Nhs TrustLondon, United Kingdom, Ec1A 7Be King'S College Hospital NhsLondon, United Kingdom, Se5 9Rs Royal Victoria Infirmary, NewcNewcastle Upon Tyne, United Kingdom, Ne1 4Lp|La Jolla, California, United States, 92037 Cedars-Sinai Medical CtrLos Angeles, California, United States, 90048 Gastrointestinal BiosciencesLos Angeles, California, United States, 90067-2001 United GastroenterologistsMurrieta, California, United States, 92563 Ucsf Center For Colitis And Crohn'S DiseaseSan Francisco, California, United States, 94115-3011 Univ Of California San FrancisSan Francisco, California, United States, 94158|Colorado Springs, Colorado, United States, 80907|Farmington, Connecticut, United States, 06032 Medical Research Ctr CtHamden, Connecticut, United States, 06518 Ct Childrens Medical Ctr, UsHartford, Connecticut, United States, 06106|Clermont, Florida, United States, 34711 Ctr For Advanced GastroenterolMaitland, Florida, United States, 32751-6108 Coral Research ClinicMiami, Florida, United States, 33186-4643 Gastroenterology Group NaplesNaples, Florida, United States, 34102 Omega Research MaitlandOrlando, Florida, United States, 32810 Clinical Research Trials Of Florida, Inc.Tampa, Florida, United States, 33607 Florida Hospital TampaTampa, Florida, United States, 33613-4680|Atlanta, Georgia, United States, 30322 Gastro Assoc Of Central GaMacon, Georgia, United States, 31201 Atlanta Gastroenterology SpecSuwanee, Georgia, United States, 30024|Chicago, Illinois, United States, 60637-1443 Dm Clinical Research/SouthwestOak Lawn, Illinois, United States, 60453|Kansas City, Kansas, United States, 66160 Cotton-O'Neil Clinical Res CtrTopeka, Kansas, United States, 66606|Baton Rouge, Louisiana, United States, 70809 Houma Digestive Health SpecialHouma, Louisiana, United States, 70360 Nola Research Works, LlcNew Orleans, Louisiana, United States, 70115 Louisiana Research Ctr. LlcShreveport, Louisiana, United States, 71105-6800|Boston, Massachusetts, United States, 02114 Children'S Hospital BostonBoston, Massachusetts, United States, 02115|Troy, Michigan, United States, 48098-6363|Rochester, Minnesota, United States, 55905-0001|Omaha, Nebraska, United States, 68114|Las Vegas, Nevada, United States, 89113|New York, New York, United States, 10032-3725 Lenox Hill Hospital, NorthwellNew York, New York, United States, 10075 Digiovanna Institute For MedicNorth Massapequa, New York, United States, 11758 Univ Rochester Med CtrRochester, New York, United States, 14642|Charlotte, North Carolina, United States, 28207 Carolina Research, Greenville, NcGreenville, North Carolina, United States, 27834|Fargo, North Dakota, United States, 58104-5925|Columbus, Ohio, United States, 43210 Optimed Research, Ltd.Columbus, Ohio, United States, 43235 Great Lakes Gastroenterology Research LlcMentor, Ohio, United States, 44060-6211|Oklahoma City, Oklahoma, United States, 73112|Philadelphia, Pennsylvania, United States, 19104-5502 Allegheny General HospitalPittsburgh, Pennsylvania, United States, 15212|Germantown, Tennessee, United States, 38138 East Tennessee Research InstitJohnson City, Tennessee, United States, 37604 Vanderbilt Univ Med CtrNashville, Tennessee, United States, 37232-0011|Baytown, Texas, United States, 77521-2415 Aztec Clinical Research, Inc.Channelview, Texas, United States, 77530 Baylor College Of MedicineHouston, Texas, United States, 77030-2608 Precision Research Institute - HoustonHouston, Texas, United States, 77036 Centex Studies, Inc. - HoustonHouston, Texas, United States, 77058 Dcol Ctr For Clinical ResearchLongview, Texas, United States, 75605 Clinical Associates In ResearcSan Antonio, Texas, United States, 78212 Sagact PllcSan Antonio, Texas, United States, 78229 Baylor Scott & White HealthTemple, Texas, United States, 76508 Tyler Research Institute, LlcTyler, Texas, United States, 75701 Victoria GastroenterologyVictoria, Texas, United States, 77904|Bountiful, Utah, United States, 84010 Advanced Research InstituteOgden, Utah, United States, 84405-6779|Norfolk, Virginia, United States, 23502|Seattle, Washington, United States, 98101 University Of WashingtonSeattle, Washington, United States, 98109 American","California|Colorado|Connecticut|Florida|Georgia|Illinois|Kansas|Louisiana|Massachusetts|Michigan|Minnesota|Nebraska|Nevada|New York|North Carolina|North Dakota|Ohio|Oklahoma|Pennsylvania|Tennessee|Texas|Utah|Virginia|Washington","Argentina|Austria|Belgium|Brazil|Bulgaria|Canada|Chile|Colombia|Croatia|Czechia|Denmark|Egypt|France|Germany|Greece|Hungary|Israel|Italy|Japan|Latvia|Lithuania|Netherlands|Poland|Portugal|Romania|Samoa|Serbia|Slovakia|South Africa|Spain|Sweden|Turkey|Ukraine|United Kingdom|United States","Cemic|Lkh-Univ. Klinikum Graz|Niederosterreich UniversitÃ¤tsklinikum St.PÃ¶lten|Wein Akh Wien|Bruxelles-Capitale Cub Hospital Erasme|Liege Chu De Liege|Oost-Vlaanderen Uz Gent|Uz Brussels|Goias Instituto Goiano De Gastroenterologia|Parana Hospital Nossa Senhora Das GraÃ§as|Rio Grande Do Sul Hospital De Clinicas De Porto Alegre|Sao Paulo Upeclin Fmb - Unesp|Umhat \"Kaspela\" Eood|Alberta University Of Calgary|British Columbia Fraser Clinical Trials Inc|Investigaciones Medicas Ssmso|Region Metropolitana De Santiago Hospital San Juan De Dios|ValparaÃ­so Centro De Investigaciones ClÃ­nicas ViÃ±a Del Mar|Fundacion Cardioinfantil|Grad Zagreb Klinicka Bolnica Dubrava Zagreb|Klinicki Bolnicki Centar Split|Osjecko-Baranjska Zupanija Klinicki Bolnicki Centar Osijek|Hepato-Gastro Hk, S.R.O.|Olomoucky Kraj Ctcenter Mave, S.R.O.|Praha 5 Axon Clinical, S.R.O.|SjÃ¦lland Sjaellands Universitets Hospit|Syddanmark Svendborg Sygehus, Sygehusenhe|University Of Alexandria|Alpes-Maritimes Chu De Nice-Hopital L'Archet Ii|Chu Amiens Picardie - Site Sud|Gironde HÃ´pital Haut-LÃ©vÃªque|Hopital Beaujon|Loire Chu De Saint Etienne - Hopital Nord|Baden-Wuerttemberg Universitatsklinikum Mannheim|Bayern Universitaetsklinikum Erlangen|CharitÃ© UniversitÃ¤tsmedizin Campus Mitte|Niedersachsen Universitatsklinikum Munster|Nordrhein-Westfalen Uniklinik Koln|Schleswig-Holstein Univ Hosp Schleswig-Holstein|Thuringen Universitaetsklinikum Ulm|Gen Hosp Chest Athens Sotiria|Heves Bugat Pal Korhaz|Kenezy Gyula Korhaz Es Rendelo|Hadarom Soroka Medical Center|Rambam Medical Center|Tel-Aviv Rabin Medical Center|Yerushalayim Hadassah Ein Kerem Medical Ctr|Calabria UniversitÃ  Di Catanzaro \"Magna Graecia\"|Emilia-Romagna Ospedale Sant Orsola Malpighi|Irccs Aou San Martino-Ist|Lazio Policlinico Universitario Campus Bio-Medico|Milano Istituto Clinico Humanitas|Sicilia A.O. Per L'Emergenza Cannizzaro|Verona Ospedale Classificato Equiparato Sacro Cuore-Don Calabria|Aichi Aichi Medical University Hosp|Asahikawa Medical Univ Hosp|Chiba Toho University Sakura Med Ctr|Fukuoka Kurume University Hospital|Gunma National Hospital Organization Takasaki General Medical Center|Hiroshima Nho Fukuyama Medical Center|Hokkaido Sapporo Medical Univ Hosp|Hyogo Aoyama Clinic|Ishikawa Kanazawa University Ho|Miyagi Tohoku University Hospital|Saitama Tokito Clinic|Shiga Shiga Univ Med Science Hosp|Tokyo Medical Hospital Of Tokyo Medical And Dental University|Yamagata Yamagata University Hospital|Riga East Clinical Univ Hosp|Kaunas Hospital Of Lithuanian Univers|Klaipeda Seamens Hospital|Elisabeth Tweesteden Ziekenhui|Noord-Holland Academisch Medisch Centrum|Kujawsko-Pomorskie Szpital Uniwersytecki Nr 2 Im. Dr J.Biziela W Bydgoszczy|Lubelskie Lubelskie Centrum Diagnostyczne|Malopolskie Centrum Medyczne Plejady|Mazowieckie Centrum Zdrowia Matki, Dziecka I Mlodziezy|Chuc- Centro Hospitalar E Univ|Faro Centro Hospitalar Do Algarve - Hospital De PortimÃ£o|Lisboa Hospital Garcia De Orta, E.P.E|Institutul Clinic Fundeni|Southern California Res. Ctr.|Sumadijski Okrug Clinical Center Kragujevac|Vojvodina Clinical Center Vojvodina|Fn S Poliklinikou F.D. Rooseve|Zilinsky Kraj Univerzitna Nemocnica Martin|, Gauteng Wits Clinical Research Site|, Western Cape Mediclinic Constantiaberg|Dr Jp Wright|Hospital Universitario Parc Tauli|Medicinmottagningen Sah Univ|Vastra Gotalands Lan AlingsÃ¥s Lasarett|Ankara Univ Medical Faculty|Kayseri Erciyes University Medical Fac|Regional Clinical Hospital|Barnsley Hospital Nhs Foundati|Ucsd|Peak Gastroenterology Associat|Connecticut Gi|South Lake Pain Institute, Inc|Emory University Hospital|University Of Chicago|Univ Kansas Med Ctr|Gastroenterology Assoc. La|Mgh Digestive Health Center|Center For Digestive Health|Mayo Clinic|Quality Clinical Research Inc.|Comprehensive Digestive Instit|Columbia Univ Medical Center|Charlotte Gastro Hepatology|Plains Clinical Research Center, Llc|The Ohio State University|Digestive Disease Specialists|University Of Pennsylvania|Gastro One|Inquest Clinical Research|Val R. Hansen|Digestive And Liver Disease Sp|Virginia Mason Medical Center",{"$nulls":3},"AbbVie Inc.","2018-05-29","2020-05-25T16:36:34.048","2020-05-26T17:10:42.972","NCT03398148"]
["5ecbf412e2561b1b11905d38","NCT03398148","2018-06-14","AbbVie","ABBV","Recruiting","A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy","Risankizumab","IL23 Inhibitor","Yes","['Risankizumab']","No",null,"Phase 2/Phase 3",16,720,"Anticipated","2018-03-07","2020-09-23",{"$nulls":5},"The objectives of Sub-Study 1 are to evaluate the efficacy, safety, and pharmacokinetics of risankizumab as induction treatment in subjects with moderately to severely active ulcerative colitis (UC), and to identify the appropriate induction dose of risankizumab for further evaluation in Sub-Study 2.\n\nThe objective of Sub-Study 2 is to evaluate the efficacy and safety of risankizumab compared to placebo in inducing clinical remission in subjects with moderately to severely active UC.",null,"A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy","M16-067","Ulcerative Colitis (UC)","Colitis|Colitis, Ulcerative","Gastrointestinal Diseases","Gastrointestinal","Experimental|Placebo Comparator","Substudy 1, Induction 2: Double-blind Risankizumab Dose 2|Substudy 2, Induction 1: Open-label Risankizumab Dose 2|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 2, Induction 2: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 2, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 3|Substudy 2, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 1, Induction 1: Open-label Risankizumab Dose 3","Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection in Induction 2.|Participants randomized to receive risankizumab dose 2 administered by intravenous (IV) infusion.|Participants who received placebo with inadequate response in Induction 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.|Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 3 administered by subcutaneous (SC) injection in Induction 2.|Participants randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion.|Participants who received placebo with inadequate response in Induction 1 receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.|Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.|Participants randomized to receive risankizumab dose 3 administered by intravenous (IV) infusion.|Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.|Participants receive risankizumab dose 3 administered by intravenous (IV) infusion.","Drug","rizankizumab SC|risankizumab IV|placebo for rizankizumab","rizankizumab subcutaneous (SC) injection|rizankizumab intravenous (IV) infusion|placebo for rizankizumab","ABBV-066 | BI 655066","Substudy 1, Induction 2: Double-blind Risankizumab Dose 2|Substudy 2, Induction 1: Open-label Risankizumab Dose 2|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 2, Induction 2: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 2, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 3|Substudy 2, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 1, Induction 1: Open-label Risankizumab Dose 3","\n\n * Male or female aged >=18 to <= 80 years at the Baseline Visit. Where locally permissible, subjects 16 to < 18 years of age who meet the definition of Tanner stage 5 for development at the Baseline Visit\n * Confirmed diagnosis of ulcerative colitis (UC) for at least 3 months prior to Baseline.\n * Active UC as assessed by adapted Mayo Score\n * Demonstrated intolerance or inadequate response to one or more biologic therapies\n * Females must be postmenopausal for more than 2 years or surgically sterile or practicing specific forms of birth control.\n\n","\n\n * Subject with a current diagnosis of Crohn's disease (CD), inflammatory bowel disease-unclassified (IBD-U) or a history of radiation colitis or ischemic colitis.\n * Subject receiving prohibited medications and treatment.\n * Extent of inflammatory disease limited to the rectum as assessed by screening endoscopy.\n * Subject with currently known complications of UC (e.g., megacolon).",{"$nulls":4},"Actual","2018-01-12","Actual","Anticipated","2021-12-25","Anticipated","2018-06-01","2018-01-08","2018-01-08","2018-06-13","Yes","ABBV-066\nBI 655066","Interventional","Treatment","Parallel Assignment","Double (Participant, Investigator)","Randomized","16 Years","80 Years","All",null,"No","Undecided",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2016-004677-40","EudraCT Number","Percentage of participants with clinical remission per adapted Mayo Score at Week 12","Clinical remission per adapted Mayo Score.","Week 12","Percentage of participants achieving clinical remission per full Mayo Score at Week 12 in subjects with a full Mayo score of 6 to 12 at Baseline|Ulcerative Colitis Symptom Questionnaire (UC-SQ): Change from Baseline to Week 12|Inflammatory Bowel Disease Questionnaire (IBDQ): Change from Baseline to Week 12|Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue): Change from Baseline to Week 12|Percentage of participants achieving clinical response per adapted Mayo Score at week 12|Percentage of participants with endoscopic remission at Week 12|Percentage of participants achieving clinical response per partial adapted Mayo Score at week 4|Percentage of participants with mucosal healing at Week 12|36-Item Short Form Health Status Survey (SF-36): Change from Baseline to Week 12|Percentage of participants with hospitalization through Week 12|Percentage of participants with Ulcerative Colitis (UC)-related surgeries through Week 12|Percentage of participants with endoscopic improvement at Week 12","Clinical remission per full Mayo Score.|The US-SQ is a patient questionnaire to assess severity of Crohn's symptoms.|The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.|The FACIT-Fatigue is a validated tool that measures an individual's level of fatigue during their usual daily activities over the past week.|Clinical response per adapted Mayo Score.|Endoscopic remission per endoscopy subscore.|Clinical response per partial adapted Mayo Score (without endoscopy).|Mucosal healing defined as endoscopic and histologic remission.|The SF-36 is an indicator of overall health status.|Participants with an event that results in admission to the hospital.|Participants who underwent surgery related to UC.|Endoscopic improvement per endoscopy subscore.","Week 12|Baseline, Week 12|Week 4|12 weeks","abbvieclinicaltrials@abbvie.com","ABBVIE CALL CENTER","847.283.8955","Buenos Aires, Argentina, 1431 Hosp Privado Ctr Med CordobaCordoba, Argentina, 5016 Sanatorio GuemesCuidad Autonoma De Buenosaires, Argentina, C1180Aad Instituto Medico CerQuilmes, Argentina, 1878 Sanatorio 9 De Julio S.A.San Miguel De Tucuman, Argentina, 4000 Hopital CentenarioSanta Fe, Argentina, 2000|Graz, Austria, 8036 Lkh Salzburg And ParacelsusSalzburg, Austria, 5020|St. PÃ¶lten, Niederosterreich, Austria, 3100|Vienna, Wein, Austria, 1090|Brussels, Bruxelles-Capitale, Belgium, 1070 Cliniques Universitaires Saint LucWoluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200|Liege, Liege, Belgium, 4000|Gent, Oost-Vlaanderen, Belgium, 9000|Jette, Brussels, Belgium, 1090 Uz LeuvenLeuven, Belgium, 3000 Clinique St JosephLiege, Belgium, 4000 Az-DeltaRoeselare, Belgium, 8800 Chu Dinant Godinne - Ucl NamurYvoir, Belgium, 5530|Goiania, Goias, Brazil, 74535-170|Curitiba, Parana, Brazil, 80810-040|Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903|Botucatu, Sao Paulo, Brazil, 18618-686 Hospital Das Clinicas Da Faculdade De Medicina De RibeirÃ£o Preto - UspRibeirÃ£o Preto, Sao Paulo, Brazil, 14048-900 Faculdade De Medicina Do AbcSanto AndrÃ©, Sao Paulo, Brazil, 09060-870 Kaiser Clinica E Hospital DiaSao Jose Do Rio Preto, Sao Paulo, Brazil, 15015-110|Plovdiv, Bulgaria, 4001 Ii Mhat - SofiaSofia, Bulgaria, 1202 Acibadem City Clinic TokudaSofia, Bulgaria, 1407|Calgary, Alberta, Canada, T2N 4Z6 South Edmonton GastroenterologEdmonton, Alberta, Canada, T6L 6K3|New Westminster, British Columbia, Canada, V3L 3W4 Percuro ClinicVictoria, British Columbia, Canada, V8R6R3|Santiago, Chile, 8207257 Hospital Las HiguerasTalcahuano, Chile|Santiago, Region Metropolitana De Santiago, Chile, 8350488 Hospital Clinico UniversidadSantiago, Region Metropolitana De Santiago, Chile, 8380456|ViÃ±a Del Mar, ValparaÃ­so, Chile, 2540488|Bogota, Colombia, 111156 Instituto De ColoproctologiaMedellin, Colombia, 050024 Hospital Universitario San VicMedellin, Colombia, 50010 Hospital Pablo Tobon UribeMedellÃ­n, Colombia|Zagreb, Grad Zagreb, Croatia, 10000 Klinicki Bolnicki Centar ZagrebZagreb, Grad Zagreb, Croatia, 10000|Split, Croatia, 21000|Osijek, Osjecko-Baranjska Zupanija, Croatia, 31000|Hradec Kralove, Czechia, 500 12 Nemocnice Pardubickeho Kraje,Pardubice, Czechia, 53203|Olomouc, Olomoucky Kraj, Czechia, 779 00|Praha, Praha 5, Czechia, 150 00|Roskilde, SjÃ¦lland, Denmark, 4000|Nyborg, Syddanmark, Denmark, 5800|Alexandria, Egypt, 21131 Nat Hep & Trop Med Res InstCairo, Egypt, 1141 Air Force Specialized HospitalCairo, Egypt National Liver InstituteMenoufiya, Egypt, 35111|Nice Cedex 3, Alpes-Maritimes, France, 06202|Amiens Cedex 1, France, 80054|Pessac Cedex, Gironde, France, 33604|Clichy, Ile-De-|St. Priest En Jarez, Loire, France, 42270|Mannheim, Baden-Wuerttemberg, Germany, 68167|Erlangen, Bayern, Germany, 91054|Berlin, Germany, 10117 Gastroenterologie Am BayerischBerlin, Germany, 10825 Drk Kliniken BerlinBerlin, Germany, 14050 Stadtisches Klinikum BraunschwBraunschweig, Germany, 38126 Agaplesion Markus KrankenhausFrankfurt, Germany, 60341 UniversitÃ¤tsklinikum FreiburgFreiburg, Germany, 79106 Asklepios Westklinikum HamburgHamburg, Germany, 22559 Med Hochschule HanoverHannover, Germany, 30625 Praxis Fuer GastroenterologieHeidelberg, Germany, 69121 Gastroenterologie OpernstrasseKassel, Germany, 34117 Klinikum LueneburgLueneburg, Germany, 21339 Gastro GemeinschaftspraxisMinden, Germany, 32423 Klinikum Univ RegensburgRegensburg, Germany, 93042 Universitatsklinikum TubingenTuebingen, Germany, 72076 Gastro-Praxis WiesbadenWiesbaden, Germany, 65189|Munster, Niedersachsen, Germany, 48149|KÃ¶ln, Nordrhein-Westfalen, Germany, 50937|Kiel, Schleswig-Holstein, Germany, 24105|Ulm, Thuringen, Germany, 89081|Athens, Greece, 11527 General Uh Of HeraklionHeraklion, Greece, 71110 Agios Panteleimon General HospPireaus, Greece, 18454 Theageneio Cancer HospitalThessaloniki, Greece, 546 39|GyÃ¶ngyÃ¶s, Heves, Hungary, 3200|Debrecen, Hungary, 4031 Miskolci Semmelweis Korhaz EsKecskemet, Hungary, 6000 Tolna Megyei Onkormanyzat BalaSzekszÃ¡rd, Hungary, 7100|Be'Er Sheva, Hadarom, Israel, 84101|Haifa, Israel, 3525408 Shaare Zedek Medical CenterJerusalem, Israel, 91031 Sheba Medical CenterRamat Gan, Israel, 5262100|Petakh Tikva, Tel-Aviv, Israel, 4941492|Jerusalem, Yerushalayim, Israel, 91120|Catanzaro, Calabria, Italy, 88100|Bologna, Emilia-Romagna, Italy, 40138 Azienda Ospedaliero-Universitaria Policlinico Di ModenaModena, Emilia-Romagna, Italy, 41124|Genoa, Italy, 16132 Azienda Ospedaliera Ospedale NMilano, Italy, 20162 Azienda Ospedaliera Luigi SaccMilan, Italy, 20157 Policlinico Tor VergataRome, Italy, 00133 Uoc Medicina Interna E GastroeRome, Italy, 168|Rome, Lazio, Italy, 00128 A.O. San Camillo-ForlaniniRome, Lazio, Italy, 00152 Azienda Policlinico Universitario Umberto IRome, Lazio, Italy, 00161|Rozzano, Milano, Italy, 20089|Catania, Sicilia, Italy, 95126|Negrar, Verona, Italy, 37024|Nagakute, Aichi, Japan, 4801195 Nagoya University HospitalNagoya-Shi, Aichi, Japan, 466-8560 Nagoya City University HospitalNagoya-Shi, Aichi, Japan, 467-8602|Asahikawa-Shi, Japan, 078-8510 Hiroshima University HospitalHiroshima, Japan, 734-8551 Ofuna Chuo HospitalKamakura, Japan The Jikei University HospitalMinato-Ku, Japan, 105-8471 Kitasato University Kitasato IMinato-Ku, Japan, 108-8642 Kitasato University HospitalSagamihara-Shi, Japan, 252-0375 Kyoto University HospitalSakyo-Ku, Japan, 606-8507 Nho Shizuoka Medical CenterShimizu-Sho, Japan Fujita Health University HospToyoake, Japan, 470-1192 Jp Red Cross Wakayama Med CtrWakayama, Japan Yokkaichi Hazu Medical CenterYokkaichi-Shi, Japan, 510-0016 Korea, Republic Of, Busan Gwang Yeogsi Dong-A University HospitalBusan, Busan Gwang Yeogsi, Korea, Republic Of, 49201 Pusan National University HospBusan, Busan Gwang Yeogsi, Korea, Republic Of, 602-739 Korea, Republic Of, Daegu Gwang Yeogsi Yeungnam University Med CtrDaegu, Daegu Gwang Yeogsi, Korea, Republic Of, 42415 Korea, Republic Of, Gyeonggido Cha Bundang Medical Center, Cha UniversitySeongnam-Si, Gyeonggido, Korea, Republic Of, 13496 St. Vincent'S HospitalSuwon, Gyeonggido, Korea, Republic Of, 16247 Korea, Republic Of, Seoul Teugbyeolsi Kangbuk Samsung HospitalJongno-Gu, Seoul Teugbyeolsi, Korea, Republic Of, 03181 Severance HospitalSeoul, Seoul Teugbyeolsi, Korea, Republic Of, 03722 Samsung Medical CenterSeoul, Seoul Teugbyeolsi, Korea, Republic Of, 06351 Korea, Republic Of Haeundae Paik HospitalBusan, Korea, Republic Of, 48108 Hanyang University Guri HospGuri-Si, Korea, Republic Of, 471-701|Sakura-Shi, Chiba, Japan, 285-8741|Kurume-Shi, Fukuoka, Japan, 830-0011|Takasaki-Shi, Gunma, Japan, 370-0829|Fukuyama-Shi, Hiroshima, Japan, 720-8520|Sapporo-Shi, Hokkaido, Japan, 060-8543 Hokkaido Sapporo-Kosei Gen HosSapporo, Hokkaido, Japan, 060-0033|Kobe, Hyogo, Japan, 650-0015|Kanazawa, Ishikawa, Japan, 92086-41|Sendai-Shi, Miyagi, Japan, 980-8574|Saitama-Shi, Saitama, Japan, 336-0963|Otsu, Shiga, Japan, 520-2192|Bunkyo-Ku, Tokyo, Japan, 113-8519 Kyorin University HospitalMitaka-Shi, Tokyo, Japan, 181-8611|Yamagata-Shi, Yamagata, Japan, 990-9585|Riga, Latvia, 1038 P. Stradins Clinical Univ HospRiga, Latvia, Lv-1002 Veselibas Centrs 4 LtdRiga, Latvia, Lv-1012|Kovno, Kaunas, Lithuania, 50161|Klaipeda, Lithuania, Lt-92288 Vilnius University HospitalVilnius, Lithuania, Lt-08661|Tilburg, Netherlands, 5022 Gc|Amsterdam, Noord-Holland, Netherlands, 1105 Az|Bydgoszcz, Kujawsko-Pomorskie, Poland, 85-168|Swidnik, Lubelskie, Poland, 21-040|Krakow, Malopolskie, Poland, 30-363|Warszawa, Mazowieckie, Poland, 01-783 Centralny Szpital Kliniczny Mswia W WarszawieWarszawa, Mazowieckie, Poland, 02-507 Centrum Onkologii-Instytut Im.M.Sklodowskiej-Curie W WarszawieWarszawa, Mazowieckie, Poland, 02-781|Coimbra, Portugal, 3000-075 Hsog - Hospital Senhora Da OliGuimaraes, Portugal, 4835-044 Centro Hospitalar De Sao Joao, EpePorto, Portugal, 4200-319 Centro Hospitalar De Entre O DSanta Maria Da Feira, Portugal, 4520-211 Centro Hosp De Tondela-ViseuViseu, Portugal, 3504 - 509|Portimao, Faro, Portugal, 8500-338|Almada, Lisboa, Portugal, 2805-267 Centro Hosp De Lisboa CentralLisbon, Lisboa, Portugal, 1169-050|Bucharest, Romania, 22328 Spitalul Clinic Judetean MuresTargu Mures, Romania, 540103 Cabinet Particular Algomed SrlTimisoara, Romania, 300002 Centrul Medical Tuculanu SrlTimisoara, Romania, 300168 Russian Federation, Kaliningradskaya Oblast Immanuel Kant Baltic Federal UniversityKaliningrad, Kaliningradskaya Oblast, Russian Federation, 236016 Russian Federation, Novosibirskaya Oblast Scientific Research Institute Of Physiology And Fundamental MedicineNovosibirsk, Novosibirskaya Oblast, Russian Federation, 630060 Russian Federation Kemerovo Regional HospitalKemerovo, Russian Federation, 650000 Scien Ctr Coloproctology RosmeMoscow, Russian Federation, 123423 Pmi EuromedservicePushkin, Russian Federation, 196603 Tyumen Regional Clinical HospiTyumen, Russian Federation, 625023 Ulyanovsk Regional Clin HospUlyanovsk, Russian Federation, 432018|Coronado, American|Kragujevac, Sumadijski Okrug, Serbia, 34000|Novi Sad, Vojvodina, Serbia, 21000|Banska Bystrica, Slovakia, 97517 Gastro I.S.R.O.Presov, Slovakia, 08001|Martin, Zilinsky Kraj, Slovakia, 036 01|Johannesburg, Gauteng, South Africa, 2193|Cape Town, Western Cape, South Africa, 7800|Cape Town, South Africa, 7708|Barcelona, Spain, 08028 Hospital Clinic De BarcelonaBarcelona, Spain, 08036 Hospital Universitario Reina SCordoba, Spain, 14004 Hospital Universitario De CabuGijon, Spain, 33394 Hospital General Universitario Gregorio MaranonMadrid, Spain, 28009 Hospital Universitario La PazMadrid, Spain, 28046 Hosp Univ Puerta De HierroMajadahonda, Spain, 28222 Compl Hospital Univer De VigoPontevedra, Spain, 36312 Hospital Clinico Univ De SalamancaSalamanca, Spain, 37007 Hospital Universitario Virgen MacarenaSevilla, Spain, 41009 Hospital De ManisesValencia, Spain, 46940 Hospital Univ Miguel ServetZaragoza, Spain, 50009|Molndal, Sweden, 431 80 Danderyds Sjukhus AbStockholm, Sweden, 182 88 Taiwan, Taipei National Taiwan University HospitalTaipei City, Taipei, Taiwan, 100 Taiwan Chung Shan Medical UniversityTaichung City, Taiwan, 40201 Taichung Veterans General HospTaichung City, Taiwan, 40705 Taipei Veterans General HospTaipei City, Taiwan, 11217|AlingsÃ¥s, Vastra Gotalands Lan, Sweden, 441 33|Ankara, Turkey, 6100 Inonu Universitesi Turgut OzalBattalgazi/Malatya, Turkey, 44280 Uludag University Medical FacultyBursa, Turkey, 16059 FÄ±rat University Medical FaculElazig, Turkey, 23100 Istanbul University Cerrahpasa Medical FacultyIstanbul, Turkey, 34098 Sisli Etfal Train & Res HospIstanbul, Turkey, 34371 Haydarpasa Numune TrainingIstanbul, Turkey, 34668 Marmara University Medical FacIstanbul, Turkey, 34899|Melikgazi, Kayseri, Turkey, 38030|Kharkov, Ukraine, 61058 Kyiv Municipal Clinical HospitKyiv, Ukraine, 01030|Barnsley, United Kingdom, S75 2Ep Royal United Hospitals BathBath, United Kingdom, Ba1 3Ng Univ Hospitals Birmingham Nhs Foundation TrustBirmingham, United Kingdom, B15 2Tg Addenbrookes HospitalCambridge, United Kingdom, Cb2 0Sp Castle Hill HospitalKingston Upon Hull, United Kingdom, Hu16 5Jq Barts And The London Nhs TrustLondon, United Kingdom, Ec1A 7Be King'S College Hospital NhsLondon, United Kingdom, Se5 9Rs Royal Victoria Infirmary, NewcNewcastle Upon Tyne, United Kingdom, Ne1 4Lp|La Jolla, California, United States, 92037 Cedars-Sinai Medical CtrLos Angeles, California, United States, 90048 Gastrointestinal BiosciencesLos Angeles, California, United States, 90067-2001 United GastroenterologistsMurrieta, California, United States, 92563 Ucsf Center For Colitis And Crohn'S DiseaseSan Francisco, California, United States, 94115-3011 Univ Of California San FrancisSan Francisco, California, United States, 94158|Colorado Springs, Colorado, United States, 80907|Farmington, Connecticut, United States, 06032 Medical Research Ctr CtHamden, Connecticut, United States, 06518 Ct Childrens Medical Ctr, UsHartford, Connecticut, United States, 06106|Clermont, Florida, United States, 34711 Ctr For Advanced GastroenterolMaitland, Florida, United States, 32751-6108 Coral Research ClinicMiami, Florida, United States, 33186-4643 Gastroenterology Group NaplesNaples, Florida, United States, 34102 Omega Research MaitlandOrlando, Florida, United States, 32810 Clinical Research Trials Of Florida, Inc.Tampa, Florida, United States, 33607 Florida Hospital TampaTampa, Florida, United States, 33613-4680|Atlanta, Georgia, United States, 30322 Gastro Assoc Of Central GaMacon, Georgia, United States, 31201 Atlanta Gastroenterology SpecSuwanee, Georgia, United States, 30024|Chicago, Illinois, United States, 60637-1443 Dm Clinical Research/SouthwestOak Lawn, Illinois, United States, 60453|Kansas City, Kansas, United States, 66160 Cotton-O'Neil Clinical Res CtrTopeka, Kansas, United States, 66606|Baton Rouge, Louisiana, United States, 70809 Houma Digestive Health SpecialHouma, Louisiana, United States, 70360 Nola Research Works, LlcNew Orleans, Louisiana, United States, 70115 Louisiana Research Ctr. 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Klinikum Graz|Niederosterreich UniversitÃ¤tsklinikum St.PÃ¶lten|Wein Akh Wien|Bruxelles-Capitale Cub Hospital Erasme|Liege Chu De Liege|Oost-Vlaanderen Uz Gent|Uz Brussels|Goias Instituto Goiano De Gastroenterologia|Parana Hospital Nossa Senhora Das GraÃ§as|Rio Grande Do Sul Hospital De Clinicas De Porto Alegre|Sao Paulo Upeclin Fmb - Unesp|Umhat \"Kaspela\" Eood|Alberta University Of Calgary|British Columbia Fraser Clinical Trials Inc|Investigaciones Medicas Ssmso|Region Metropolitana De Santiago Hospital San Juan De Dios|ValparaÃ­so Centro De Investigaciones ClÃ­nicas ViÃ±a Del Mar|Fundacion Cardioinfantil|Grad Zagreb Klinicka Bolnica Dubrava Zagreb|Klinicki Bolnicki Centar Split|Osjecko-Baranjska Zupanija Klinicki Bolnicki Centar Osijek|Hepato-Gastro Hk, S.R.O.|Olomoucky Kraj Ctcenter Mave, S.R.O.|Praha 5 Axon Clinical, S.R.O.|SjÃ¦lland Sjaellands Universitets Hospit|Syddanmark Svendborg Sygehus, Sygehusenhe|University Of Alexandria|Alpes-Maritimes Chu De Nice-Hopital L'Archet Ii|Chu Amiens Picardie - Site Sud|Gironde HÃ´pital Haut-LÃ©vÃªque|Hopital Beaujon|Loire Chu De Saint Etienne - Hopital Nord|Baden-Wuerttemberg Universitatsklinikum Mannheim|Bayern Universitaetsklinikum Erlangen|CharitÃ© UniversitÃ¤tsmedizin Campus Mitte|Niedersachsen Universitatsklinikum Munster|Nordrhein-Westfalen Uniklinik Koln|Schleswig-Holstein Univ Hosp Schleswig-Holstein|Thuringen Universitaetsklinikum Ulm|Gen Hosp Chest Athens Sotiria|Heves Bugat Pal Korhaz|Kenezy Gyula Korhaz Es Rendelo|Hadarom Soroka Medical Center|Rambam Medical Center|Tel-Aviv Rabin Medical Center|Yerushalayim Hadassah Ein Kerem Medical Ctr|Calabria UniversitÃ  Di Catanzaro \"Magna Graecia\"|Emilia-Romagna Ospedale Sant Orsola Malpighi|Irccs Aou San Martino-Ist|Lazio Policlinico Universitario Campus Bio-Medico|Milano Istituto Clinico Humanitas|Sicilia A.O. 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Dr J.Biziela W Bydgoszczy|Lubelskie Lubelskie Centrum Diagnostyczne|Malopolskie Centrum Medyczne Plejady|Mazowieckie Centrum Zdrowia Matki, Dziecka I Mlodziezy|Chuc- Centro Hospitalar E Univ|Faro Centro Hospitalar Do Algarve - Hospital De PortimÃ£o|Lisboa Hospital Garcia De Orta, E.P.E|Institutul Clinic Fundeni|Southern California Res. Ctr.|Sumadijski Okrug Clinical Center Kragujevac|Vojvodina Clinical Center Vojvodina|Fn S Poliklinikou F.D. Rooseve|Zilinsky Kraj Univerzitna Nemocnica Martin|, Gauteng Wits Clinical Research Site|, Western Cape Mediclinic Constantiaberg|Dr Jp Wright|Hospital Universitario Parc Tauli|Medicinmottagningen Sah Univ|Vastra Gotalands Lan AlingsÃ¥s Lasarett|Ankara Univ Medical Faculty|Kayseri Erciyes University Medical Fac|Regional Clinical Hospital|Barnsley Hospital Nhs Foundati|Ucsd|Peak Gastroenterology Associat|Connecticut Gi|South Lake Pain Institute, Inc|Emory University Hospital|University Of Chicago|Univ Kansas Med Ctr|Gastroenterology Assoc. La|Mgh Digestive Health Center|Center For Digestive Health|Mayo Clinic|Quality Clinical Research Inc.|Comprehensive Digestive Instit|Columbia Univ Medical Center|Charlotte Gastro Hepatology|Plains Clinical Research Center, Llc|The Ohio State University|Digestive Disease Specialists|University Of Pennsylvania|Gastro One|Inquest Clinical Research|Val R. Hansen|Digestive And Liver Disease Sp|Virginia Mason Medical Center",{"$nulls":3},"AbbVie Inc.","2018-06-13","2020-05-25T16:36:34.218","2020-05-26T17:10:42.972","NCT03398148"]
["5ecbf412fe30261b1a04823d","NCT03398148","2018-08-01","AbbVie","ABBV","Recruiting","A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy","Risankizumab","IL23 Inhibitor","Yes","['Risankizumab']","No",null,"Phase 2/Phase 3",16,720,"Anticipated","2018-03-07","2020-09-23",{"$nulls":5},"The objectives of Sub-Study 1 are to evaluate the efficacy, safety, and pharmacokinetics of risankizumab as induction treatment in subjects with moderately to severely active ulcerative colitis (UC), and to identify the appropriate induction dose of risankizumab for further evaluation in Sub-Study 2.\n\nThe objective of Sub-Study 2 is to evaluate the efficacy and safety of risankizumab compared to placebo in inducing clinical remission in subjects with moderately to severely active UC.",null,"A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy","M16-067","Ulcerative Colitis (UC)","Colitis|Colitis, Ulcerative","Gastrointestinal Diseases","Gastrointestinal","Experimental|Placebo Comparator","Substudy 1, Induction 2: Double-blind Risankizumab Dose 2|Substudy 2, Induction 1: Open-label Risankizumab Dose 2|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 2, Induction 2: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 2, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 3|Substudy 2, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 1, Induction 1: Open-label Risankizumab Dose 3","Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection in Induction 2.|Participants randomized to receive risankizumab dose 2 administered by intravenous (IV) infusion.|Participants who received placebo with inadequate response in Induction 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.|Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 3 administered by subcutaneous (SC) injection in Induction 2.|Participants randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion.|Participants who received placebo with inadequate response in Induction 1 receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.|Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.|Participants randomized to receive risankizumab dose 3 administered by intravenous (IV) infusion.|Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.|Participants receive risankizumab dose 3 administered by intravenous (IV) infusion.","Drug","rizankizumab SC|risankizumab IV|placebo for rizankizumab","rizankizumab subcutaneous (SC) injection|rizankizumab intravenous (IV) infusion|placebo for rizankizumab","ABBV-066 | BI 655066","Substudy 1, Induction 2: Double-blind Risankizumab Dose 2|Substudy 2, Induction 1: Open-label Risankizumab Dose 2|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 2, Induction 2: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 2, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 3|Substudy 2, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 1, Induction 1: Open-label Risankizumab Dose 3","\n\n * Male or female aged >=18 to <= 80 years at the Baseline Visit. Where locally permissible, subjects 16 to < 18 years of age who meet the definition of Tanner stage 5 for development at the Baseline Visit\n * Confirmed diagnosis of ulcerative colitis (UC) for at least 3 months prior to Baseline.\n * Active UC as assessed by adapted Mayo Score\n * Demonstrated intolerance or inadequate response to one or more biologic therapies\n * Females must be postmenopausal for more than 2 years or surgically sterile or practicing specific forms of birth control.\n\n","\n\n * Subject with a current diagnosis of Crohn's disease (CD), inflammatory bowel disease-unclassified (IBD-U) or a history of radiation colitis or ischemic colitis.\n * Subject receiving prohibited medications and treatment.\n * Extent of inflammatory disease limited to the rectum as assessed by screening endoscopy.\n * Subject with currently known complications of UC (e.g., megacolon).",{"$nulls":4},"Actual","2018-01-12","Actual","Anticipated","2021-12-25","Anticipated","2018-07-01","2018-01-08","2018-01-08","2018-07-31","Yes","ABBV-066\nBI 655066","Interventional","Treatment","Parallel Assignment","Double (Participant, Investigator)","Randomized","16 Years","80 Years","All",null,"No","Yes\nAbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",{"$nulls":3},"Yes","No",{"$nulls":4},"Yes",{"$nulls":12},"2016-004677-40","EudraCT Number","Percentage of participants with clinical remission per adapted Mayo Score at Week 12","Clinical remission per adapted Mayo Score.","Week 12","Percentage of participants achieving clinical remission per full Mayo Score at Week 12 in subjects with a full Mayo score of 6 to 12 at Baseline|Ulcerative Colititis Symptom Questionnaire (UC-SQ): Change from Baseline to Week 12|Inflammatory Bowel Disease Questionnaire (IBDQ): Change from Baseline to Week 12|Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue): Change from Baseline to Week 12|Percentage of participants achieving clinical response per adapted Mayo Score at week 12|Percentage of participants with endoscopic remission at Week 12|Percentage of participants achieving clinical response per partial adapted Mayo Score at week 4|Percentage of participants with mucosal healing at Week 12|36-Item Short Form Health Status Survey (SF-36): Change from Baseline to Week 12|Percentage of participants with hospitalization through Week 12|Percentage of participants with Ulcerative Colitis (UC)-related surgeries through Week 12|Percentage of participants with endoscopic improvement at Week 12","Clinical remission per full Mayo Score.|The US-SQ is a patient questionnaire to assess severity of Crohn's symptoms.|The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.|The FACIT-Fatigue is a validated tool that measures an individual's level of fatigue during their usual daily activities over the past week.|Clinical response per adapted Mayo Score.|Endoscopic remission per endoscopy subscore.|Clinical response per partial adapted Mayo Score (without endoscopy).|Mucosal healing defined as endoscopic and histologic remission.|The SF-36 is an indicator of overall health status.|Participants with an event that results in admission to the hospital.|Participants who underwent surgery related to UC.|Endoscopic improvement per endoscopy subscore.","Week 12|Baseline, Week 12|Week 4|12 weeks","abbvieclinicaltrials@abbvie.com","ABBVIE CALL CENTER","847.283.8955",{"$cut":{"chars":19945,"head":"Buenos Aires, Argentina, 1431 Hosp Privado Ctr Med Cordoba /Id# 167779Cordoba, Argentina, 5016 Sanatorio Guemes /Id# 170585Cuidad Autonoma De Buenosaires, Argentina, C1180Aad Instituto Medico Cer /Id# 168686Quilmes, Argentina, 1878 Sanatorio 9 De Julio S.A. /Id# 167780San Miguel De Tucuman, Argentina, 4000 Hopital Centenario /Id# 170898Santa Fe, Argentina, 2000|South Brisbane, Queensland, Australia, 4101|Graz, Austria, 8036 Lkh Salzburg And Paracelsus /Id# 200685Salzburg, Austria, 5020|St. PÃ¶lten, Niederoesterreich, Austria, 3100|Vienna, Wien, Austria, 1090|Brussels, Bruxelles-Capitale, Belgium, 1070 Cliniques Universitaires Saint Luc /Id# 200039Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200|Liege, Liege, Belgium, 4000|Gent, Oost-Vlaanderen, Belgium, 9000|Jette, Brussels, Belgium, 1090 Uz Leuven /Id# 170812Leuven, Belgium, 3000 Clinique St Joseph /Id# 200250Liege, Belgium, 4000 Az-Delta /Id# 200040Roeselare, Belgium, 8800 Chu Dinant Godinne - 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Klinikum Graz /Id# 169053|Niederoesterreich UniversitÃ¤tsklinikum St.PÃ¶lten /Id# 169048|Wien Medical University Of Vienna /Id# 169050|Bruxelles-Capitale Cub Hospital Erasme /Id# 200252|Liege Chu De Liege /Id# 200253|Oost-Vlaanderen Uz Gent /Id# 200251|Uz Brussels /Id# 164176|Goias Instituto Goiano De Gastroenterologia /Id# 157679|Parana Hospital Nossa Senhora Das GraÃ§as /Id# 157671|Rio Grande Do Sul Hospital De Clinicas De Porto Alegre /Id# 157662|Sao Paulo Upeclin Fmb - Unesp /Id# 157690|Umhat \"Kaspela\" Eood /Id# 200797|Alberta University Of Calgary /Id# 169111|British Columbia Fraser Clinical Trials Inc /Id# 169102|New Brunswick Qeii Health Sciences Centre /Id# 169107|Nova Scotia Iwk Health Center /Id# 169110|Ontario London Health Sciences Centre /Id# 169103|Quebec Hopital Charles-Lemoyne /Id# 169105|Hospital Las Higueras /Id# 167093|Region Metropolitana De Santiago Complejo Asistencial Dr. Sotero Del Rio /Id# 169385|ValparaÃ­so Centro De Investigaciones ClÃ­nicas ViÃ±a Del Mar /Id# 203607|Cundinamarca Corporacion Hospitalaria Juan Ciudad Sed|Instituto De Coloproctologia /Id# 158739|Grad Zagreb Klinicka Bolnica Dubrava Zagreb /Id# 157475|Klinicki Bolnicki Centar Split /Id# 157473|Osjecko-Baranjska Zupanija Klinicki Bolnicki Centar Osijek /Id# 157472|Hepato-Gastro Hk, S.R.O. /Id# 163395|Olomoucky Kraj Ctcenter Mave, S.R.O. /Id# 163392|Praha 5 Axon Clinical, S.R.O. /Id# 163393|Hvidovre Hospital /Id# 202266|Midtjylland Aarhus University Hospital /Id# 200032|SjÃ¦lland Sjaellands Universitets Hospit /Id# 200033|Syddanmark Svendborg Sygehus, Sygehusenhe /Id# 200034|University Of Alexandria /Id# 200848|Alpes-Maritimes Chu De Nice-Hopital L'Archet Ii /Id# 171577|Chu Amiens Picardie - Site Sud /Id# 171576|Gironde HÃ´pital Haut-LÃ©vÃªque /Id# 171579|Hopital Beaujon /Id# 200092|Loire Chu De Saint Etienne - Hopital Nord /Id# 171580|Baden-Wuerttemberg Universitatsklinikum Mannheim /Id# 162035|Bayern Universitaetsklinikum Erlangen /Id# 159354|CharitÃ© UniversitÃ¤tsmedizin Campus Mitte /Id# 163688|Niedersachsen Universitatsklinikum Munster /Id# 159355|Nordrhein-Westfalen Uniklinik Koln /Id# 164991|Schleswig-Holstein Univ Hosp Schleswig-Holstein /Id# 159360|Thueringen Universitaetsklinikum Ulm /Id# 164992|Gen Hosp Chest Athens Sotiria /Id# 170915|Baranya Mohacsi Korhaz /Id# 205347|Borsod-Abauj-Zemplen Miskolci Semmelweis Korhaz Es /Id# 201285|Heves Bugat Pal Korhaz /Id# 202528|Mh Egeszsegugyi Kozpont /Id# 157329|Pest Obudai Egeszsegugyi Kozpont /Id# 201922|Hadarom Soroka Medical Center /Id# 171100|Rambam Medical Center /Id# 171101|Tel-Aviv Rabin Medical Center /Id# 167403|Yerushalayim Hadassah Ein Kerem Medical Ctr /Id# 171099|Calabria UniversitÃ  Di Catanzaro \"Magna Graecia\" /Id# 200125|Emilia-Romagna Ospedale Sant Orsola Malpighi /Id# 155611|Irccs Aou San Martino-Ist /Id# 164031|Lazio Policlinico Universitario Campus Bio-Medico /Id# 163992|Milano Istituto Clinico Humanitas /Id# 155610|Sicilia A.O. Per L'Emergenza Cannizzaro /Id# 164036|Verona Ospedale Classificato Equiparato Sacro Cuore-Don Calabria /Id# 164041|Aichi Aichi Medical University Hosp /Id# 164332|Chiba Toho University Sakura Med Ctr /Id# 164254|Fukuoka Kurume University Hospital /Id# 164427|Gunma National Hospital Organization Takasaki General Medical Center /Id# 164437|Hiroshima Nho Fukuyama Medical Center /Id# 164439|Hiroshima University Hospital /Id# 164426|Hokkaido Asahikawa Medical University Hospital /Id# 164433|Hyogo Aoyama Clinic /Id# 164425|Ishikawa Kanazawa University Ho /Id# 169224|Kanagawa Ofuna Chuo Hospital /Id# 169300|Mie Mie University Hospital /Id# 203633|Miyagi Tohoku University Hospital /Id# 164430|Nagasaki Nagasaki University Hospital /Id# 202674|Saitama Tokito Clinic /Id# 164253|Shiga Shiga Univ Med Science Hosp /Id# 164440|Tokyo Medical Hospital Of Tokyo Medical And Dental University /Id# 164258|Yamagata Yamagata University Hospital /Id# 171474|Riga East Clinical Univ Hosp /Id# 163802|Kaunas Hospital Of Lithuanian Univers /Id# 170714|Klaipeda Seamens Hospital /Id# 170847|Selangor Ukm Medical Centre /Id# 200635|Jalisco Ibiomed Guadalajara /Id# 203592|Jm Research /Id# 203593|Elisabeth Tweesteden Ziekenhui /Id# 163767|Noord-Holland Academisch Medisch Centrum /Id# 157959|, Canterbury Christchurch Hospital /Id# 205342|Wellington Hospital /Id# 205343|Kujawsko-Pomorskie Szpital Uniwersytecki Nr 2 Im. Dr J.Biziela W Bydgoszczy /Id# 170599|Lubelskie Lubelskie Centrum Diagnostyczne /Id# 170602|Malopolskie Centrum Medyczne Plejady /Id# 170633|Mazowieckie Centrum Zdrowia Mdm /Id# 170597|Chuc- Centro Hospitalar E Univ /Id# 166054|Faro Centro Hospitalar Do Algarve - Hospital De PortimÃ£o /Id# 166551|Lisboa Hospital Garcia De Orta, E.P.E /Id# 165583|Institutul Clinic Fundeni /Id# 171264|Southern California Res. Ctr. /Id# 169660|/Id# 200152|Sumadijski Okrug Clinical Center Kragujevac /Id# 156913|Fn S Poliklinikou F.D. Rooseve /Id# 164347|, Gauteng Wits Clinical Research Site /Id# 171136|, Western Cape Mediclinic Constantiaberg /Id# 171137|Dr Jp Wright /Id# 171138|Hospital Universitario Parc Tauli /Id# 159461|Medicinmottagningen Sah Univ /Id# 202843|Vastra Gotalands Lan AlingsÃ¥s Lasarett /Id# 202074|Ankara Univ Medical Faculty /Id# 167210|Kayseri Erciyes University Medical Fac /Id# 171291|Kyivska Oblast Medical Centre Of \"Ok!Clinic\" Of \"International Institute Of Clinical Trials\" /Id# 205482|Regional Clinical Hospital /Id# 203367|Barnsley Hospital Nhs Foundati /Id# 202770|Ucsd /Id# 160452|Peak Gastroenterology Associat /Id# 165841|Connecticut Gi /Id# 164715|South Lake Pain Institute, Inc /Id# 162878|Emory University Hospital /Id# 160583|University Of Chicago /Id# 160521|Indiana University /Id# 167252|Univ Kansas Med Ctr /Id# 161868|Houma Digestive Health Special /Id# 158317|Mgh Digestive Health Center /Id# 164255|Center For Digestive Health /Id# 160327|Mayo Clinic - Rochester /Id# 200458|Quality Clinical Research Inc. /Id# 167313|Comprehensive Digestive Instit /Id# 160178|North Shore University Hospital /Id# 168746|Charlotte Gastro Hepatology /Id# 158512|Plains Clinical Research Center, Llc /Id# 169732|The Ohio State University - Columbus /Id# 164714|Digestive Disease Specialists /Id# 170779|University Of Pennsylvania /Id# 166266|Greenville Endoscopy Center /Id# 160472|Gastro One /Id# 160418|Inquest Clinical Research /Id# 165685|Val R. Hansen /Id# 163007|Virginia Mason Medical Center /Id# 160466",{"$nulls":3},"AbbVie Inc.","2018-07-31","2020-05-25T16:36:34.271","2020-05-26T17:10:42.972","NCT03398148"]
["5ecbf41211702c1b1b916a4e","NCT03398148","2018-08-31","AbbVie","ABBV","Recruiting","A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy","Risankizumab","IL23 Inhibitor","Yes","['Risankizumab']","No",null,"Phase 2/Phase 3",16,720,"Anticipated","2018-03-07","2020-09-23",{"$nulls":5},"The objectives of Sub-Study 1 are to evaluate the efficacy, safety, and pharmacokinetics of risankizumab as induction treatment in subjects with moderately to severely active ulcerative colitis (UC), and to identify the appropriate induction dose of risankizumab for further evaluation in Sub-Study 2.\n\nThe objective of Sub-Study 2 is to evaluate the efficacy and safety of risankizumab compared to placebo in inducing clinical remission in subjects with moderately to severely active UC.",null,"A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy","M16-067","Ulcerative Colitis (UC)","Colitis|Colitis, Ulcerative","Gastrointestinal Diseases","Gastrointestinal","Experimental|Placebo Comparator","Substudy 1, Induction 2: Double-blind Risankizumab Dose 2|Substudy 2, Induction 1: Open-label Risankizumab Dose 2|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 2, Induction 2: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 2, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 3|Substudy 2, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 1, Induction 1: Open-label Risankizumab Dose 3","Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection in Induction 2.|Participants randomized to receive risankizumab dose 2 administered by intravenous (IV) infusion.|Participants who received placebo with inadequate response in Induction 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.|Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 3 administered by subcutaneous (SC) injection in Induction 2.|Participants randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion.|Participants who received placebo with inadequate response in Induction 1 receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.|Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.|Participants randomized to receive risankizumab dose 3 administered by intravenous (IV) infusion.|Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.|Participants receive risankizumab dose 3 administered by intravenous (IV) infusion.","Drug","rizankizumab SC|risankizumab IV|placebo for rizankizumab","rizankizumab subcutaneous (SC) injection|rizankizumab intravenous (IV) infusion|placebo for rizankizumab","ABBV-066 | BI 655066","Substudy 1, Induction 2: Double-blind Risankizumab Dose 2|Substudy 2, Induction 1: Open-label Risankizumab Dose 2|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 2, Induction 2: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 2, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 3|Substudy 2, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 1, Induction 1: Open-label Risankizumab Dose 3","\n\n * Male or female aged >=18 to <= 80 years at the Baseline Visit. Where locally permissible, subjects 16 to < 18 years of age who meet the definition of Tanner stage 5 for development at the Baseline Visit\n * Confirmed diagnosis of ulcerative colitis (UC) for at least 3 months prior to Baseline.\n * Active UC as assessed by adapted Mayo Score\n * Demonstrated intolerance or inadequate response to one or more biologic therapies\n * Females must be postmenopausal for more than 2 years or surgically sterile or practicing specific forms of birth control.\n\n","\n\n * Subject with a current diagnosis of Crohn's disease (CD), inflammatory bowel disease-unclassified (IBD-U) or a history of radiation colitis or ischemic colitis.\n * Subject receiving prohibited medications and treatment.\n * Extent of inflammatory disease limited to the rectum as assessed by screening endoscopy.\n * Subject with currently known complications of UC (e.g., megacolon).",{"$nulls":4},"Actual","2018-01-12","Actual","Anticipated","2021-12-25","Anticipated","2018-08-01","2018-01-08","2018-01-08","2018-08-28","Yes","ABBV-066\nBI 655066","Interventional","Treatment","Parallel Assignment","Double (Participant, Investigator)","Randomized","16 Years","80 Years","All",null,"No","Yes\nAbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2016-004677-40","EudraCT Number","Percentage of participants with clinical remission per adapted Mayo Score at Week 12","Clinical remission per adapted Mayo Score.","Week 12","Percentage of participants achieving clinical remission per full Mayo Score at Week 12 in subjects with a full Mayo score of 6 to 12 at Baseline|Ulcerative Colititis Symptom Questionnaire (UC-SQ): Change from Baseline to Week 12|Inflammatory Bowel Disease Questionnaire (IBDQ): Change from Baseline to Week 12|Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue): Change from Baseline to Week 12|Percentage of participants achieving clinical response per adapted Mayo Score at week 12|Percentage of participants with endoscopic remission at Week 12|Percentage of participants achieving clinical response per partial adapted Mayo Score at week 4|Percentage of participants with mucosal healing at Week 12|36-Item Short Form Health Status Survey (SF-36): Change from Baseline to Week 12|Percentage of participants with hospitalization through Week 12|Percentage of participants with Ulcerative Colitis (UC)-related surgeries through Week 12|Percentage of participants with endoscopic improvement at Week 12","Clinical remission per full Mayo Score.|The US-SQ is a patient questionnaire to assess severity of Crohn's symptoms.|The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.|The FACIT-Fatigue is a validated tool that measures an individual's level of fatigue during their usual daily activities over the past week.|Clinical response per adapted Mayo Score.|Endoscopic remission per endoscopy subscore.|Clinical response per partial adapted Mayo Score (without endoscopy).|Mucosal healing defined as endoscopic and histologic remission.|The SF-36 is an indicator of overall health status.|Participants with an event that results in admission to the hospital.|Participants who underwent surgery related to UC.|Endoscopic improvement per endoscopy subscore.","Week 12|Baseline, Week 12|Week 4|12 weeks","abbvieclinicaltrials@abbvie.com","ABBVIE CALL CENTER","847.283.8955",{"$cut":{"chars":19368,"head":"Buenos Aires, Argentina, 1431 Hosp Privado Ctr Med Cordoba /Id# 167779Cordoba, Argentina, 5016 Sanatorio Guemes /Id# 170585Cuidad Autonoma De Buenosaires, Argentina, C1180Aad Instituto Medico Cer /Id# 168686Quilmes, Argentina, 1878 Sanatorio 9 De Julio S.A. /Id# 167780San Miguel De Tucuman, Argentina, 4000 Hopital Centenario /Id# 170898Santa Fe, Argentina, 2000|South Brisbane, Queensland, Australia, 4101|Graz, Austria, 8036 Lkh Salzburg And Paracelsus /Id# 200685Salzburg, Austria, 5020|St. PÃ¶lten, Niederoesterreich, Austria, 3100|Vienna, Wien, Austria, 1090|Brussels, Bruxelles-Capitale, Belgium, 1070 Cliniques Universitaires Saint Luc /Id# 200039Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200|Liege, Liege, Belgium, 4000|Gent, Oost-Vlaanderen, Belgium, 9000|Jette, Brussels, Belgium, 1090 Uz Leuven /Id# 170812Leuven, Belgium, 3000 Clinique St Joseph /Id# 200250Liege, Belgium, 4000 Az-Delta /Id# 200040Roeselare, Belgium, 8800 Chu Dinant Godinne - Ucl Namur /Id# 200254Yvoir, Belgium, 5530|Goiania, Goias, Brazil, 74535-170|Curitiba, Parana, Brazil, 80810-040|Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903|Botucatu, Sao Paulo, Brazil, 18618-686 Hospital Das Clinicas Da Faculdade De Medicina De RibeirÃ£o Preto - Usp /Id# 157660RibeirÃ£o Preto, Sao Paulo, Brazil, 14048-900 Faculdade De Medicina Do Abc /Id# 163995Santo AndrÃ©, Sao Paulo, Brazil, 09060-870 Kaiser Clinica E Hospital Dia /Id# 157680Sao Jose Do Rio Preto, Sao Paulo, Brazil, 15015-110|Plovdiv, Bulgaria, 4001 Ii Mhat - Sofia /Id# 200799Sofia, Bulgaria, 1202 Umhat Sv. 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Klinikum Graz /Id# 169053|Niederoesterreich UniversitÃ¤tsklinikum St.PÃ¶lten /Id# 169048|Wien Medical University Of Vienna /Id# 169050|Bruxelles-Capitale Cub Hospital Erasme /Id# 200252|Liege Chu De Liege /Id# 200253|Oost-Vlaanderen Uz Gent /Id# 200251|Uz Brussels /Id# 164176|Goias Instituto Goiano De Gastroenterologia /Id# 157679|Parana Hospital Nossa Senhora Das GraÃ§as /Id# 157671|Rio Grande Do Sul Hospital De Clinicas De Porto Alegre /Id# 157662|Sao Paulo Upeclin Fmb - Unesp /Id# 157690|Umhat \"Kaspela\" Eood /Id# 200797|Alberta University Of Calgary /Id# 169111|British Columbia Fraser Clinical Trials Inc /Id# 169102|New Brunswick Qeii Health Sciences Centre /Id# 169107|Nova Scotia Iwk Health Center /Id# 169110|Ontario London Health Sciences Centre /Id# 169103|Quebec Hopital Charles-Lemoyne /Id# 169105|Hospital Las Higueras /Id# 167093|Region Metropolitana De Santiago Complejo Asistencial Dr. Sotero Del Rio /Id# 169385|ValparaÃ­so Centro De Investigaciones ClÃ­nicas ViÃ±a Del Mar /Id# 203607|Cundinamarca Corporacion Hospitalaria Juan Ciudad Sed|Instituto De Coloproctologia /Id# 158739|Grad Zagreb Klinicka Bolnica Dubrava Zagreb /Id# 157475|Klinicki Bolnicki Centar Split /Id# 157473|Osjecko-Baranjska Zupanija Klinicki Bolnicki Centar Osijek /Id# 157472|Hvidovre Hospital /Id# 202266|Midtjylland Aarhus University Hospital /Id# 200032|SjÃ¦lland Sjaellands Universitets Hospit /Id# 200033|Syddanmark Svendborg Sygehus, Sygehusenhe /Id# 200034|University Of Alexandria /Id# 200848|Alpes-Maritimes Chu De Nice-Hopital L'Archet Ii /Id# 171577|Chu Amiens Picardie - Site Sud /Id# 171576|Gironde HÃ´pital Haut-LÃ©vÃªque /Id# 171579|Hopital Beaujon /Id# 200092|Loire Chu De Saint Etienne - Hopital Nord /Id# 171580|Baden-Wuerttemberg Universitatsklinikum Mannheim /Id# 162035|Bayern Universitaetsklinikum Erlangen /Id# 159354|CharitÃ© UniversitÃ¤tsmedizin Campus Mitte /Id# 163688|Niedersachsen Universitatsklinikum Munster /Id# 159355|Nordrhein-Westfalen Uniklinik Koln /Id# 164991|Schleswig-Holstein Univ Hosp Schleswig-Holstein /Id# 159360|Thueringen Universitaetsklinikum Ulm /Id# 164992|Gen Hosp Chest Athens Sotiria /Id# 170915|Baranya Mohacsi Korhaz /Id# 205347|Borsod-Abauj-Zemplen Miskolci Semmelweis Korhaz Es /Id# 201285|Heves Bugat Pal Korhaz /Id# 202528|Mh Egeszsegugyi Kozpont /Id# 157329|Pest Obudai Egeszsegugyi Kozpont /Id# 201922|Hadarom Soroka Medical Center /Id# 171100|Rambam Medical Center /Id# 171101|Tel-Aviv Rabin Medical Center /Id# 167403|Yerushalayim Hadassah Ein Kerem Medical Ctr /Id# 171099|Calabria UniversitÃ  Di Catanzaro \"Magna Graecia\" /Id# 200125|Emilia-Romagna Ospedale Sant Orsola Malpighi /Id# 155611|Irccs Aou San Martino-Ist /Id# 164031|Lazio Policlinico Universitario Campus Bio-Medico /Id# 163992|Milano Istituto Clinico Humanitas /Id# 155610|Sicilia A.O. Per L'Emergenza Cannizzaro /Id# 164036|Verona Ospedale Classificato Equiparato Sacro Cuore-Don Calabria /Id# 164041|Aichi Aichi Medical University Hosp /Id# 164332|Chiba Toho University Sakura Med Ctr /Id# 164254|Fukuoka Kurume University Hospital /Id# 164427|Gunma National Hospital Organization Takasaki General Medical Center /Id# 164437|Hiroshima Nho Fukuyama Medical Center /Id# 164439|Hiroshima University Hospital /Id# 164426|Hokkaido Asahikawa Medical University Hospital /Id# 164433|Hyogo Aoyama Clinic /Id# 164425|Ishikawa Kanazawa University Ho /Id# 169224|Kanagawa Ofuna Chuo Hospital /Id# 169300|Mie Mie University Hospital /Id# 203633|Miyagi Tohoku University Hospital /Id# 164430|Nagasaki Nagasaki University Hospital /Id# 202674|Saitama Tokito Clinic /Id# 164253|Shiga Shiga Univ Med Science Hosp /Id# 164440|Tokyo Medical Hospital Of Tokyo Medical And Dental University /Id# 164258|Yamagata Yamagata University Hospital /Id# 171474|Riga East Clinical Univ Hosp /Id# 163802|Kaunas Hospital Of Lithuanian Univers /Id# 170714|Klaipeda Seamens Hospital /Id# 170847|Selangor Ukm Medical Centre /Id# 200635|Jalisco Ibiomed Guadalajara /Id# 203592|Jm Research /Id# 203593|Elisabeth Tweesteden Ziekenhui /Id# 163767|Noord-Holland Academisch Medisch Centrum /Id# 157959|, Canterbury Christchurch Hospital /Id# 205342|Wellington Hospital (Capital And Coast District Health Board) /Id# 205343|Kujawsko-Pomorskie Szpital Uniwersytecki Nr 2 Im. 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Rooseve /Id# 164347|, Gauteng Wits Clinical Research Site /Id# 171136|, Western Cape Mediclinic Constantiaberg /Id# 171137|Dr Jp Wright /Id# 171138|Hospital Universitario Parc Tauli /Id# 159461|Pontevedra Hospital Alvaro Cunqueiro /Id# 167360|Medicinmottagningen Sah Univ /Id# 202843|Vastra Gotalands Lan AlingsÃ¥s Lasarett /Id# 202074|Universitaetsspital Basel /Id# 206682|Ankara Univ Medical Faculty /Id# 167210|Kayseri Erciyes University Medical Fac /Id# 171291|Kyivska Oblast Medical Centre Of \"Ok!Clinic\" Of \"International Institute Of Clinical Trials\" /Id# 205482|Regional Clinical Hospital /Id# 203367|, Devon Rd&E Hospital /Id# 157587|Barnsley Hospital Nhs Foundati /Id# 202770|Ucsd /Id# 160452|Peak Gastroenterology Associat /Id# 165841|Medical Research Ctr Ct /Id# 160311|South Lake Pain Institute, Inc /Id# 162878|Emory University Hospital /Id# 160583|University Of Chicago /Id# 160521|Indiana University /Id# 167252|Univ Kansas Med Ctr /Id# 161868|Houma Digestive Health Special /Id# 158317|Mgh Digestive Health Center /Id# 164255|Center For Digestive Health /Id# 160327|Mayo Clinic - Rochester /Id# 200458|Quality Clinical Research Inc. /Id# 167313|Columbia Univ Medical Center /Id# 161934|Charlotte Gastro Hepatology /Id# 158512|Plains Clinical Research Center, Llc /Id# 169732|The Ohio State University - Columbus /Id# 164714|Digestive Disease Specialists /Id# 170779|University Of Pennsylvania /Id# 166266|Greenville Endoscopy Center /Id# 160472|Gastro One /Id# 160418|Inquest Clinical Research /Id# 165685|Val R. Hansen /Id# 163007|Virginia Mason Medical Center /Id# 160466",{"$nulls":3},"AbbVie Inc.","2018-08-28","2020-05-25T16:36:34.620","2020-05-26T17:10:42.972","NCT03398148"]
["5ecbf412307e3d1b1f8d9cce","NCT03398148","2018-09-25","AbbVie","ABBV","Recruiting","A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy","Risankizumab","IL23 Inhibitor","Yes","['Risankizumab']","No",null,"Phase 2/Phase 3",16,720,"Anticipated","2018-03-07","2020-09-23",{"$nulls":5},"The objectives of Sub-Study 1 are to evaluate the efficacy, safety, and pharmacokinetics of risankizumab as induction treatment in subjects with moderately to severely active ulcerative colitis (UC), and to identify the appropriate induction dose of risankizumab for further evaluation in Sub-Study 2.\n\nThe objective of Sub-Study 2 is to evaluate the efficacy and safety of risankizumab compared to placebo in inducing clinical remission in subjects with moderately to severely active UC.",null,"A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy","M16-067","Ulcerative Colitis (UC)","Colitis|Colitis, Ulcerative","Gastrointestinal Diseases","Gastrointestinal","Experimental|Placebo Comparator","Substudy 1, Induction 2: Double-blind Risankizumab Dose 2|Substudy 2, Induction 1: Open-label Risankizumab Dose 2|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 2, Induction 2: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 2, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 3|Substudy 2, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 1, Induction 1: Open-label Risankizumab Dose 3","Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection in Induction 2.|Participants randomized to receive risankizumab dose 2 administered by intravenous (IV) infusion.|Participants who received placebo with inadequate response in Induction 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.|Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 3 administered by subcutaneous (SC) injection in Induction 2.|Participants randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion.|Participants who received placebo with inadequate response in Induction 1 receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.|Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.|Participants randomized to receive risankizumab dose 3 administered by intravenous (IV) infusion.|Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.|Participants receive risankizumab dose 3 administered by intravenous (IV) infusion.","Drug","rizankizumab SC|risankizumab IV|placebo for rizankizumab","rizankizumab subcutaneous (SC) injection|rizankizumab intravenous (IV) infusion|placebo for rizankizumab","ABBV-066 | BI 655066","Substudy 1, Induction 2: Double-blind Risankizumab Dose 2|Substudy 2, Induction 1: Open-label Risankizumab Dose 2|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 2, Induction 2: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 2, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 3|Substudy 2, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 1, Induction 1: Open-label Risankizumab Dose 3","\n\n * Male or female aged >=18 to <= 80 years at the Baseline Visit. Where locally permissible, subjects 16 to < 18 years of age who meet the definition of Tanner stage 5 for development at the Baseline Visit\n * Confirmed diagnosis of ulcerative colitis (UC) for at least 3 months prior to Baseline.\n * Active UC as assessed by adapted Mayo Score\n * Demonstrated intolerance or inadequate response to one or more biologic therapies\n * Females must be postmenopausal for more than 2 years or surgically sterile or practicing specific forms of birth control.\n\n","\n\n * Subject with a current diagnosis of Crohn's disease (CD), inflammatory bowel disease-unclassified (IBD-U) or a history of radiation colitis or ischemic colitis.\n * Subject receiving prohibited medications and treatment.\n * Extent of inflammatory disease limited to the rectum as assessed by screening endoscopy.\n * Subject with currently known complications of UC (e.g., megacolon).",{"$nulls":4},"Actual","2018-01-12","Actual","Anticipated","2021-12-25","Anticipated","2018-09-01","2018-01-08","2018-01-08","2018-09-21","Yes","ABBV-066\nBI 655066","Interventional","Treatment","Parallel Assignment","Double (Participant, Investigator)","Randomized","16 Years","80 Years","All",null,"No","Yes\nAbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2016-004677-40","EudraCT Number","Percentage of participants with clinical remission per adapted Mayo Score at Week 12","Clinical remission per adapted Mayo Score.","Week 12","Percentage of participants achieving clinical remission per full Mayo Score at Week 12 in subjects with a full Mayo score of 6 to 12 at Baseline|Ulcerative Colititis Symptom Questionnaire (UC-SQ): Change from Baseline to Week 12|Inflammatory Bowel Disease Questionnaire (IBDQ): Change from Baseline to Week 12|Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue): Change from Baseline to Week 12|Percentage of participants achieving clinical response per adapted Mayo Score at week 12|Percentage of participants with endoscopic remission at Week 12|Percentage of participants achieving clinical response per partial adapted Mayo Score at week 4|Percentage of participants with mucosal healing at Week 12|36-Item Short Form Health Status Survey (SF-36): Change from Baseline to Week 12|Percentage of participants with hospitalization through Week 12|Percentage of participants with Ulcerative Colitis (UC)-related surgeries through Week 12|Percentage of participants with endoscopic improvement at Week 12","Clinical remission per full Mayo Score.|The US-SQ is a patient questionnaire to assess severity of Crohn's symptoms.|The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.|The FACIT-Fatigue is a validated tool that measures an individual's level of fatigue during their usual daily activities over the past week.|Clinical response per adapted Mayo Score.|Endoscopic remission per endoscopy subscore.|Clinical response per partial adapted Mayo Score (without endoscopy).|Mucosal healing defined as endoscopic and histologic remission.|The SF-36 is an indicator of overall health status.|Participants with an event that results in admission to the hospital.|Participants who underwent surgery related to UC.|Endoscopic improvement per endoscopy subscore.","Week 12|Baseline, Week 12|Week 4|12 weeks","abbvieclinicaltrials@abbvie.com","ABBVIE CALL CENTER","847.283.8955",{"$cut":{"chars":20442,"head":"Buenos Aires, Argentina, 1431 Sanatorio Guemes /Id# 170585Cuidad Autonoma De Buenosaires, Argentina, C1180Aad Instituto Medico Cer /Id# 168686Quilmes, Argentina, 1878 Sanatorio 9 De Julio S.A. /Id# 167780San Miguel De Tucuman, Argentina, 4000 Hopital Centenario /Id# 170898Santa Fe, Argentina, 2000|South Brisbane, Queensland, Australia, 4101|Graz, Austria, 8036 Lkh Salzburg And Paracelsus /Id# 200685Salzburg, Austria, 5020|St. PÃ¶lten, Niederoesterreich, Austria, 3100|Vienna, Wien, Austria, 1090|Brussels, Bruxelles-Capitale, Belgium, 1070 Cliniques Universitaires Saint Luc /Id# 200039Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200|Liege, Liege, Belgium, 4000|Gent, Oost-Vlaanderen, Belgium, 9000|Jette, Brussels, Belgium, 1090 Uz Leuven /Id# 170812Leuven, Belgium, 3000 Clinique St Joseph /Id# 200250Liege, Belgium, 4000 Az-Delta /Id# 200040Roeselare, Belgium, 8800 Chu Dinant Godinne - Ucl Namur /Id# 200254Yvoir, Belgium, 5530|Goiania, Goias, Brazil, 74535-170|Curitiba, Parana, Brazil, 80810-040|Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903|Botucatu, Sao Paulo, Brazil, 18618-686 Hospital Das Clinicas Da Faculdade De Medicina De RibeirÃ£o Preto - Usp /Id# 157660RibeirÃ£o Preto, Sao Paulo, Brazil, 14048-900 Faculdade De Medicina Do Abc /Id# 163995Santo AndrÃ©, Sao Paulo, Brazil, 09060-870 Kaiser Clinica E Hospital Dia /Id# 157680Sao Jose Do Rio Preto, Sao Paulo, Brazil, 15015-110|Sofia, Bulgaria, 1202 Umhat Sv. 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Rooseve /Id# 164347|, Free State Farmovs Integrated Research Solutions /Id# 207537|, Gauteng Wits Clinical Research Site /Id# 171136|, Western Cape Mediclinic Constantiaberg /Id# 171137|Dr Jp Wright /Id# 171138|Hospital Universitario Parc Tauli /Id# 159461|Pontevedra Hospital Alvaro Cunqueiro /Id# 167360|Su Molndal. /Id# 202843|Vastra Gotalands Lan AlingsÃ¥s Lasarett /Id# 202074|Universitaetsspital Basel /Id# 206682|Ankara Univ Medical Faculty /Id# 167210|Kayseri Erciyes University Medical Fac /Id# 171291|Kyivska Oblast Medical Centre Of Ok!Clinic Of International Institute Of Clinical Trials /Id# 205482|Regional Clinical Hospital /Id# 203367|, Devon Rd&E Hospital /Id# 157587|Barnsley Hospital Nhs Foundati /Id# 202770|University Arizona Cancer Ctr /Id# 158407|Ucsd /Id# 160452|Peak Gastroenterology Associat /Id# 165841|Medical Research Ctr Ct /Id# 160311|South Lake Pain Institute, Inc /Id# 162878|Emory University Hospital /Id# 160583|University Of Chicago /Id# 160521|Indiana University /Id# 167252|Univ Kansas Med Ctr /Id# 161868|Delricht Research /Id# 206815|Mgh Digestive Health Center /Id# 164255|Center For Digestive Health /Id# 160327|Mayo Clinic - Rochester /Id# 200458|Quality Clinical Research Inc. /Id# 167313|Columbia Univ Medical Center /Id# 161934|Charlotte Gastro Hepatology /Id# 158512|Plains Clinical Research Center, Llc /Id# 169732|The Ohio State University - Columbus /Id# 164714|Digestive Disease Specialists /Id# 170779|University Of Pennsylvania /Id# 166266|Greenville Endoscopy Center /Id# 160472|Gastro One /Id# 160418|Inquest Clinical Research /Id# 165685|Val R. Hansen /Id# 163007|Virginia Mason Medical Center /Id# 160466",{"$nulls":3},"AbbVie Inc.","2018-09-21","2020-05-25T16:36:34.840","2020-05-26T17:10:42.972","NCT03398148"]
["5ecbf412feab101b1553086e","NCT03398148","2018-10-04","AbbVie","ABBV","Recruiting","A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy","Risankizumab","IL23 Inhibitor","Yes","['Risankizumab']","No",null,"Phase 2/Phase 3",16,720,"Anticipated","2018-03-07","2020-09-23",{"$nulls":5},"The objectives of Sub-Study 1 are to evaluate the efficacy, safety, and pharmacokinetics of risankizumab as induction treatment in subjects with moderately to severely active ulcerative colitis (UC), and to identify the appropriate induction dose of risankizumab for further evaluation in Sub-Study 2.\n\nThe objective of Sub-Study 2 is to evaluate the efficacy and safety of risankizumab compared to placebo in inducing clinical remission in subjects with moderately to severely active UC.",null,"A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy","M16-067","Ulcerative Colitis (UC)","Colitis|Colitis, Ulcerative","Gastrointestinal Diseases","Gastrointestinal","Experimental|Placebo Comparator","Substudy 1, Induction 2: Double-blind Risankizumab Dose 2|Substudy 2, Induction 1: Open-label Risankizumab Dose 2|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 2, Induction 2: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 2, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 3|Substudy 2, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 1, Induction 1: Open-label Risankizumab Dose 3","Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection in Induction 2.|Participants randomized to receive risankizumab dose 2 administered by intravenous (IV) infusion.|Participants who received placebo with inadequate response in Induction 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.|Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 3 administered by subcutaneous (SC) injection in Induction 2.|Participants randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion.|Participants who received placebo with inadequate response in Induction 1 receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.|Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.|Participants randomized to receive risankizumab dose 3 administered by intravenous (IV) infusion.|Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.|Participants receive risankizumab dose 3 administered by intravenous (IV) infusion.","Drug","risankizumab SC|risankizumab IV|placebo for risankizumab","risankizumab subcutaneous (SC) injection|risankizumab intravenous (IV) infusion|placebo for risankizumab","ABBV-066 | BI 655066","Substudy 1, Induction 2: Double-blind Risankizumab Dose 2|Substudy 2, Induction 1: Open-label Risankizumab Dose 2|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 2, Induction 2: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 2, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 3|Substudy 2, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 1, Induction 1: Open-label Risankizumab Dose 3","\n\n * Male or female aged >=18 to <= 80 years at the Baseline Visit. Where locally permissible, subjects 16 to < 18 years of age who meet the definition of Tanner stage 5 for development at the Baseline Visit\n * Confirmed diagnosis of ulcerative colitis (UC) for at least 3 months prior to Baseline.\n * Active UC as assessed by adapted Mayo Score\n * Demonstrated intolerance or inadequate response to one or more biologic therapies\n * Females must be postmenopausal for more than 2 years or surgically sterile or practicing specific forms of birth control.\n\n","\n\n * Subject with a current diagnosis of Crohn's disease (CD), inflammatory bowel disease-unclassified (IBD-U) or a history of radiation colitis or ischemic colitis.\n * Subject receiving prohibited medications and treatment.\n * Extent of inflammatory disease limited to the rectum as assessed by screening endoscopy.\n * Subject with currently known complications of UC (e.g., megacolon).",{"$nulls":4},"Actual","2018-01-12","Actual","Anticipated","2021-12-25","Anticipated","2018-10-01","2018-01-08","2018-01-08","2018-10-02","Yes","ABBV-066\nBI 655066","Interventional","Treatment","Parallel Assignment","Double (Participant, Investigator)","Randomized","16 Years","80 Years","All",null,"No","Yes\nAbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2016-004677-40","EudraCT Number","Percentage of participants with clinical remission per adapted Mayo Score at Week 12","Clinical remission per adapted Mayo Score.","Week 12","Percentage of participants achieving clinical remission per full Mayo Score at Week 12 in subjects with a full Mayo score of 6 to 12 at Baseline|Ulcerative Colititis Symptom Questionnaire (UC-SQ): Change from Baseline to Week 12|Inflammatory Bowel Disease Questionnaire (IBDQ): Change from Baseline to Week 12|Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue): Change from Baseline to Week 12|Percentage of participants achieving clinical response per adapted Mayo Score at week 12|Percentage of participants with endoscopic remission at Week 12|Percentage of participants achieving clinical response per partial adapted Mayo Score at week 4|Percentage of participants with mucosal healing at Week 12|36-Item Short Form Health Status Survey (SF-36): Change from Baseline to Week 12|Percentage of participants with hospitalization through Week 12|Percentage of participants with Ulcerative Colitis (UC)-related surgeries through Week 12|Percentage of participants with endoscopic improvement at Week 12","Clinical remission per full Mayo Score.|The US-SQ is a patient questionnaire to assess severity of Crohn's symptoms.|The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.|The FACIT-Fatigue is a validated tool that measures an individual's level of fatigue during their usual daily activities over the past week.|Clinical response per adapted Mayo Score.|Endoscopic remission per endoscopy subscore.|Clinical response per partial adapted Mayo Score (without endoscopy).|Mucosal healing defined as endoscopic and histologic remission.|The SF-36 is an indicator of overall health status.|Participants with an event that results in admission to the hospital.|Participants who underwent surgery related to UC.|Endoscopic improvement per endoscopy subscore.","Week 12|Baseline, Week 12|Week 4|12 weeks","abbvieclinicaltrials@abbvie.com","ABBVIE CALL CENTER","847.283.8955",{"$cut":{"chars":20312,"head":"Buenos Aires, Argentina, 1431 Instituto Medico Cer /Id# 168686Quilmes, Argentina, 1878 Sanatorio 9 De Julio S.A. /Id# 167780San Miguel De Tucuman, Argentina, 4000 Hopital Centenario /Id# 170898Santa Fe, Argentina, 2000|Graz, Austria, 8036 Lkh Salzburg And Paracelsus /Id# 200685Salzburg, Austria, 5020|St. PÃ¶lten, Niederoesterreich, Austria, 3100|Vienna, Wien, Austria, 1090|Brussels, Bruxelles-Capitale, Belgium, 1070 Cliniques Universitaires Saint Luc /Id# 200039Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200|Liege, Liege, Belgium, 4000|Gent, Oost-Vlaanderen, Belgium, 9000|Jette, Brussels, Belgium, 1090 Uz Leuven /Id# 170812Leuven, Belgium, 3000 Clinique St Joseph /Id# 200250Liege, Belgium, 4000 Az-Delta /Id# 200040Roeselare, Belgium, 8800 Chu Dinant Godinne - Ucl Namur /Id# 200254Yvoir, Belgium, 5530|Goiania, Goias, Brazil, 74535-170|Curitiba, Parana, Brazil, 80810-040|Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903|Botucatu, Sao Paulo, Brazil, 18618-686 Hospital Das Clinicas Da Faculdade De Medicina De RibeirÃ£o Preto - Usp /Id# 157660RibeirÃ£o Preto, Sao Paulo, Brazil, 14048-900 Faculdade De Medicina Do Abc /Id# 163995Santo AndrÃ©, Sao Paulo, Brazil, 09060-870 Kaiser Clinica E Hospital Dia /Id# 157680Sao Jose Do Rio Preto, Sao Paulo, Brazil, 15015-110|Sofia, Bulgaria, 1202 Umhat Tsaritsa Joanna - Isul /Id# 207907Sofia, Bulgaria, 1527 Umhat Sv. 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Klinikum Graz /Id# 169053|Niederoesterreich UniversitÃ¤tsklinikum St.PÃ¶lten /Id# 169048|Wien Medical University Of Vienna /Id# 169050|Bruxelles-Capitale Cub Hospital Erasme /Id# 200252|Liege Chu De Liege /Id# 200253|Oost-Vlaanderen Uz Gent /Id# 200251|Uz Brussels /Id# 164176|Goias Instituto Goiano De Gastroenterologia /Id# 157679|Parana Hospital Nossa Senhora Das GraÃ§as /Id# 157671|Rio Grande Do Sul Hospital De Clinicas De Porto Alegre /Id# 157662|Sao Paulo Upeclin Fmb - Unesp /Id# 157690|Ii Mhat - Sofia /Id# 200799|Alberta University Of Calgary /Id# 169111|British Columbia Fraser Clinical Trials Inc /Id# 169102|New Brunswick Qeii Health Sciences Centre /Id# 169107|Ontario London Health Sciences Centre /Id# 169103|Quebec Hopital Charles-Lemoyne /Id# 169105|Hospital Las Higueras /Id# 167093|Region Metropolitana De Santiago Complejo Asistencial Dr. Sotero Del Rio /Id# 169385|ValparaÃ­so Centro De Investigaciones ClÃ­nicas ViÃ±a Del Mar /Id# 203607|Cundinamarca Corporacion Hospitalaria Juan Ciudad Sed|Instituto De Coloproctologia /Id# 158739|Grad Zagreb Klinicka Bolnica Dubrava Zagreb /Id# 157475|Klinicki Bolnicki Centar Split /Id# 157473|Osjecko-Baranjska Zupanija Klinicki Bolnicki Centar Osijek /Id# 157472|Hvidovre Hospital /Id# 202266|Midtjylland Aarhus University Hospital /Id# 200032|SjÃ¦lland Sjaellands Universitets Hospit /Id# 200033|Syddanmark Svendborg Sygehus, Sygehusenhe /Id# 200034|University Of Alexandria /Id# 200848|Alpes-Maritimes Chu De Nice-Hopital L'Archet Ii /Id# 171577|Chu Amiens Picardie - Site Sud /Id# 171576|Gironde HÃ´pital Haut-LÃ©vÃªque /Id# 171579|Hopital Beaujon /Id# 200092|Loire Chu De Saint Etienne - Hopital Nord /Id# 171580|Baden-Wuerttemberg Universitatsklinikum Mannheim /Id# 162035|Bayern Universitaetsklinikum Erlangen /Id# 159354|CharitÃ© UniversitÃ¤tsmedizin Campus Mitte /Id# 163688|Nordrhein-Westfalen Uniklinik Koln /Id# 164991|Schleswig-Holstein Univ Hosp Schleswig-Holstein /Id# 159360|Thueringen Universitaetsklinikum Ulm /Id# 164992|Attiki General Hospital Of Athens Laiko /Id# 206440|General Hospital Of Chest Diseases Of Athens \"Sotiria\" /Id# 170915|Baranya Mohacsi Korhaz /Id# 205347|Borsod-Abauj-Zemplen Miskolci Semmelweis Korhaz Es /Id# 201285|Heves Bugat Pal Korhaz /Id# 202528|Magyar Honvedseg Egeszsegugyi Kozpont /Id# 157329|Pest Obudai Egeszsegugyi Kozpont /Id# 201922|Hadarom Soroka Medical Center /Id# 171100|Rambam Medical Center /Id# 171101|Tel-Aviv Rabin Medical Center /Id# 167403|Yerushalayim Hadassah Ein Kerem Medical Ctr /Id# 171099|Calabria UniversitÃ  Di Catanzaro \"Magna Graecia\" /Id# 200125|Emilia-Romagna Ospedale Sant Orsola Malpighi /Id# 155611|Irccs Aou San Martino-Ist /Id# 164031|Lazio Policlinico Universitario Campus Bio-Medico /Id# 163992|Milano Istituto Clinico Humanitas /Id# 155610|Sicilia A.O. 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Rooseve /Id# 164347|, Free State Farmovs Integrated Research Solutions /Id# 207537|, Gauteng Wits Clinical Research Site /Id# 171136|, Western Cape Mediclinic Constantiaberg /Id# 171137|Dr Jp Wright /Id# 171138|Hospital Universitario Parc Tauli /Id# 159461|Pontevedra Hospital Alvaro Cunqueiro /Id# 167360|Su Molndal. /Id# 202843|Vastra Gotalands Lan AlingsÃ¥s Lasarett /Id# 202074|University Hospital Zurich /Id# 202910|Ankara Univ Medical Faculty /Id# 167210|Kayseri Erciyes University Medical Fac /Id# 171291|Kyivska Oblast Medical Centre Of Ok!Clinic Of International Institute Of Clinical Trials /Id# 205482|Regional Clinical Hospital /Id# 203367|, Devon Rd&E Hospital /Id# 157587|Barnsley Hospital Nhs Foundati /Id# 202770|University Arizona Cancer Ctr /Id# 158407|Ucsd /Id# 160452|Peak Gastroenterology Associat /Id# 165841|Medical Research Ctr Ct /Id# 160311|South Lake Pain Institute, Inc /Id# 162878|Emory University Hospital /Id# 160583|University Of Chicago /Id# 160521|Indiana University /Id# 167252|Univ Kansas Med Ctr /Id# 161868|Delricht Research /Id# 206815|Mgh Digestive Health Center /Id# 164255|Center For Digestive Health /Id# 160327|Mayo Clinic - Rochester /Id# 200458|Quality Clinical Research Inc. /Id# 167313|Columbia Univ Medical Center /Id# 161934|Carolinas Medical Center /Id# 158512|Plains Clinical Research Center, Llc /Id# 169732|The Ohio State University - Columbus /Id# 164714|Digestive Disease Specialists /Id# 170779|University Of Pennsylvania /Id# 166266|Greenville Endoscopy Center /Id# 160472|Gastro One /Id# 160418|Inquest Clinical Research /Id# 165685|Val R. Hansen /Id# 163007|Virginia Mason Medical Center /Id# 160466",{"$nulls":3},"AbbVie Inc.","2018-10-02","2020-05-25T16:36:34.900","2020-05-26T17:10:42.972","NCT03398148"]
["5ecbf413fe30261b1a04823e","NCT03398148","2018-10-19","AbbVie","ABBV","Recruiting","A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy","Risankizumab","IL23 Inhibitor","Yes","['Risankizumab']","No",null,"Phase 2/Phase 3",16,720,"Anticipated","2018-03-07","2020-09-23",{"$nulls":5},"The objectives of Sub-Study 1 are to evaluate the efficacy, safety, and pharmacokinetics of risankizumab as induction treatment in subjects with moderately to severely active ulcerative colitis (UC), and to identify the appropriate induction dose of risankizumab for further evaluation in Sub-Study 2.\n\nThe objective of Sub-Study 2 is to evaluate the efficacy and safety of risankizumab compared to placebo in inducing clinical remission in subjects with moderately to severely active UC.",null,"A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy","M16-067","Ulcerative Colitis (UC)","Colitis|Colitis, Ulcerative","Gastrointestinal Diseases","Gastrointestinal","Experimental|Placebo Comparator","Substudy 1, Induction 2: Double-blind Risankizumab Dose 2|Substudy 2, Induction 1: Open-label Risankizumab Dose 2|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 2, Induction 2: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 2, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 3|Substudy 2, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 1, Induction 1: Open-label Risankizumab Dose 3","Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection in Induction 2.|Participants randomized to receive risankizumab dose 2 administered by intravenous (IV) infusion.|Participants who received placebo with inadequate response in Induction 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.|Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 3 administered by subcutaneous (SC) injection in Induction 2.|Participants randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion.|Participants who received placebo with inadequate response in Induction 1 receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.|Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.|Participants randomized to receive risankizumab dose 3 administered by intravenous (IV) infusion.|Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.|Participants receive risankizumab dose 3 administered by intravenous (IV) infusion.","Drug","risankizumab SC|risankizumab IV|placebo for risankizumab","risankizumab subcutaneous (SC) injection|rizankizumab intravenous (IV) infusion|placebo for risankizumab","ABBV-066 | BI 655066","Substudy 1, Induction 2: Double-blind Risankizumab Dose 2|Substudy 2, Induction 1: Open-label Risankizumab Dose 2|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 2, Induction 2: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 2, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 3|Substudy 2, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 1, Induction 1: Open-label Risankizumab Dose 3","\n\n * Male or female aged >=18 to <= 80 years at the Baseline Visit. Where locally permissible, subjects 16 to < 18 years of age who meet the definition of Tanner stage 5 for development at the Baseline Visit\n * Confirmed diagnosis of ulcerative colitis (UC) for at least 3 months prior to Baseline.\n * Active UC as assessed by adapted Mayo Score\n * Demonstrated intolerance or inadequate response to one or more biologic therapies\n * Females must be postmenopausal for more than 2 years or surgically sterile or practicing specific forms of birth control.\n\n","\n\n * Subject with a current diagnosis of Crohn's disease (CD), inflammatory bowel disease-unclassified (IBD-U) or a history of radiation colitis or ischemic colitis.\n * Subject receiving prohibited medications and treatment.\n * Extent of inflammatory disease limited to the rectum as assessed by screening endoscopy.\n * Subject with currently known complications of UC (e.g., megacolon).",{"$nulls":4},"Actual","2018-01-12","Actual","Anticipated","2021-12-25","Anticipated","2018-10-01","2018-01-08","2018-01-08","2018-10-17","Yes","ABBV-066\nBI 655066","Interventional","Treatment","Parallel Assignment","Double (Participant, Investigator)","Randomized","16 Years","80 Years","All",null,"No","Yes\nAbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2016-004677-40","EudraCT Number","Percentage of participants with clinical remission per adapted Mayo Score at Week 12","Clinical remission per adapted Mayo Score.","Week 12","Percentage of participants achieving clinical remission per full Mayo Score at Week 12 in subjects with a full Mayo score of 6 to 12 at Baseline|Ulcerative Colititis Symptom Questionnaire (UC-SQ): Change from Baseline to Week 12|Inflammatory Bowel Disease Questionnaire (IBDQ): Change from Baseline to Week 12|Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue): Change from Baseline to Week 12|Percentage of participants achieving clinical response per adapted Mayo Score at week 12|Percentage of participants with endoscopic remission at Week 12|Percentage of participants achieving clinical response per partial adapted Mayo Score at week 4|Percentage of participants with mucosal healing at Week 12|36-Item Short Form Health Status Survey (SF-36): Change from Baseline to Week 12|Percentage of participants with hospitalization through Week 12|Percentage of participants with Ulcerative Colitis (UC)-related surgeries through Week 12|Percentage of participants with endoscopic improvement at Week 12","Clinical remission per full Mayo Score.|The US-SQ is a patient questionnaire to assess severity of Crohn's symptoms.|The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.|The FACIT-Fatigue is a validated tool that measures an individual's level of fatigue during their usual daily activities over the past week.|Clinical response per adapted Mayo Score.|Endoscopic remission per endoscopy subscore.|Clinical response per partial adapted Mayo Score (without endoscopy).|Mucosal healing defined as endoscopic and histologic remission.|The SF-36 is an indicator of overall health status.|Participants with an event that results in admission to the hospital.|Participants who underwent surgery related to UC.|Endoscopic improvement per endoscopy subscore.","Week 12|Baseline, Week 12|Week 4|12 weeks","abbvieclinicaltrials@abbvie.com","ABBVIE CALL CENTER","847.283.8955",{"$cut":{"chars":20274,"head":"Buenos Aires, Argentina, 1431 Instituto Medico Cer /Id# 168686Quilmes, Argentina, 1878 Sanatorio 9 De Julio S.A. /Id# 167780San Miguel De Tucuman, Argentina, 4000 Hopital Centenario /Id# 170898Santa Fe, Argentina, 2000|Graz, Austria, 8036 Lkh Salzburg And Paracelsus /Id# 200685Salzburg, Austria, 5020|St. PÃ¶lten, Niederoesterreich, Austria, 3100|Vienna, Wien, Austria, 1090|Brussels, Bruxelles-Capitale, Belgium, 1070 Cliniques Universitaires Saint Luc /Id# 200039Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200|Liege, Liege, Belgium, 4000|Gent, Oost-Vlaanderen, Belgium, 9000|Jette, Brussels, Belgium, 1090 Uz Leuven /Id# 170812Leuven, Belgium, 3000 Clinique St Joseph /Id# 200250Liege, Belgium, 4000 Az-Delta /Id# 200040Roeselare, Belgium, 8800 Chu Dinant Godinne - Ucl Namur /Id# 200254Yvoir, Belgium, 5530|Goiania, Goias, Brazil, 74535-170|Curitiba, Parana, Brazil, 80810-040|Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903|Botucatu, Sao Paulo, Brazil, 18618-686 Hospital Das Clinicas Da Faculdade De Medicina De RibeirÃ£o Preto - Usp /Id# 157660RibeirÃ£o Preto, Sao Paulo, Brazil, 14048-900 Faculdade De Medicina Do Abc /Id# 163995Santo AndrÃ©, Sao Paulo, Brazil, 09060-870 Kaiser Clinica E Hospital Dia /Id# 157680Sao Jose Do Rio Preto, Sao Paulo, Brazil, 15015-110|Sofia, Bulgaria, 1202 Umhat Tsaritsa Joanna - Isul /Id# 207907Sofia, Bulgaria, 1527 Umhat Sv. 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Klinikum Graz /Id# 169053|Niederoesterreich UniversitÃ¤tsklinikum St.PÃ¶lten /Id# 169048|Wien Medical University Of Vienna /Id# 169050|Bruxelles-Capitale Cub Hospital Erasme /Id# 200252|Liege Chu De Liege /Id# 200253|Oost-Vlaanderen Uz Gent /Id# 200251|Uz Brussels /Id# 164176|Goias Instituto Goiano De Gastroenterologia /Id# 157679|Parana Hospital Nossa Senhora Das GraÃ§as /Id# 157671|Rio Grande Do Sul Hospital De Clinicas De Porto Alegre /Id# 157662|Sao Paulo Upeclin Fmb - Unesp /Id# 157690|Ii Mhat - Sofia /Id# 200799|Alberta University Of Calgary /Id# 169111|British Columbia Fraser Clinical Trials Inc /Id# 169102|New Brunswick Qeii Health Sciences Centre /Id# 169107|Nova Scotia Iwk Health Center /Id# 169110|Ontario London Health Sciences Centre /Id# 169103|Quebec Hopital Charles-Lemoyne /Id# 169105|Hospital Las Higueras /Id# 167093|Region Metropolitana De Santiago Complejo Asistencial Dr. Sotero Del Rio /Id# 169385|ValparaÃ­so Centro De Investigaciones ClÃ­nicas ViÃ±a Del Mar /Id# 203607|Cundinamarca Corporacion Hospitalaria Juan Ciudad Sed|Instituto De Coloproctologia /Id# 158739|Grad Zagreb Klinicka Bolnica Dubrava Zagreb /Id# 157475|Klinicki Bolnicki Centar Split /Id# 157473|Osjecko-Baranjska Zupanija Klinicki Bolnicki Centar Osijek /Id# 157472|Hvidovre Hospital /Id# 202266|Midtjylland Aarhus University Hospital /Id# 200032|SjÃ¦lland Sjaellands Universitets Hospit /Id# 200033|Syddanmark Svendborg Sygehus, Sygehusenhe /Id# 200034|University Of Alexandria /Id# 200848|Alpes-Maritimes Chu De Nice-Hopital L'Archet Ii /Id# 171577|Chu Amiens Picardie - Site Sud /Id# 171576|Gironde HÃ´pital Haut-LÃ©vÃªque /Id# 171579|Hopital Beaujon /Id# 200092|Loire Chu De Saint Etienne - Hopital Nord /Id# 171580|Baden-Wuerttemberg Universitatsklinikum Mannheim /Id# 162035|Bayern Universitaetsklinikum Erlangen /Id# 159354|CharitÃ© UniversitÃ¤tsmedizin Campus Mitte /Id# 163688|Nordrhein-Westfalen Uniklinik Koln /Id# 164991|Schleswig-Holstein Univ Hosp Schleswig-Holstein /Id# 159360|Thueringen Universitaetsklinikum Ulm /Id# 164992|Attiki General Hospital Of Athens Laiko /Id# 206440|General Hospital Of Chest Diseases Of Athens \"Sotiria\" /Id# 170915|Baranya Mohacsi Korhaz /Id# 205347|Borsod-Abauj-Zemplen Miskolci Semmelweis Korhaz Es /Id# 201285|Heves Bugat Pal Korhaz /Id# 202528|Magyar Honvedseg Egeszsegugyi Kozpont /Id# 157329|Pest Obudai Egeszsegugyi Kozpont /Id# 201922|Hadarom Soroka Medical Center /Id# 171100|Rambam Medical Center /Id# 171101|Tel-Aviv Rabin Medical Center /Id# 167403|Yerushalayim Hadassah Ein Kerem Medical Ctr /Id# 171099|Calabria UniversitÃ  Di Catanzaro \"Magna Graecia\" /Id# 200125|Emilia-Romagna Ospedale Sant Orsola Malpighi /Id# 155611|Irccs Aou San Martino-Ist /Id# 164031|Lazio Policlinico Universitario Campus Bio-Medico /Id# 163992|Milano Istituto Clinico Humanitas /Id# 155610|Sicilia A.O. Per L'Emergenza Cannizzaro /Id# 164036|Verona Ospedale Classificato Equiparato Sacro Cuore-Don Calabria /Id# 164041|Aichi Aichi Medical University Hosp /Id# 164332|Chiba Toho University Sakura Medical Center /Id# 164254|Fukuoka Kurume University Hospital /Id# 164427|Gifu Gifu University Hospital /Id# 208081|Gunma National Hospital Organization Takasaki General Medical Center /Id# 164437|Hiroshima Nho Fukuyama Medical Center /Id# 164439|Hiroshima University Hospital /Id# 164426|Hokkaido Asahikawa Medical University Hospital /Id# 164433|Hyogo Aoyama Clinic /Id# 164425|Ishikawa Kanazawa University Ho /Id# 169224|Kanagawa Gokeikai Ofuna Chuo Hospital /Id# 169300|Mie Mie University Hospital /Id# 203633|Miyagi Tohoku University Hospital /Id# 164430|Nagasaki Nagasaki University Hospital /Id# 202674|Saitama Tokito Clinic /Id# 164253|Shiga Shiga Univ Med Science Hosp /Id# 164440|Tokyo Medical Hospital Of Tokyo Medical And Dental University /Id# 164258|Yamagata Yamagata University Hospital /Id# 171474|Riga East Clinical Univ Hosp /Id# 163802|Kaunas Hospital Of Lithuanian Univers /Id# 170714|Klaipeda Seamens Hospital /Id# 170847|Selangor Ukm Medical Centre /Id# 200635|Jalisco InvestigaciÃ³n BiomÃ©dica Para El Desarrollo De FÃ¡rmacos, S.A. 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Rooseve /Id# 164347|, Free State Farmovs Integrated Research Solutions /Id# 207537|, Gauteng Wits Clinical Research Site /Id# 171136|, Western Cape Mediclinic Constantiaberg /Id# 171137|Dr Jp Wright /Id# 171138|Hospital Universitario Parc Tauli /Id# 159461|Pontevedra Hospital Alvaro Cunqueiro /Id# 167360|Su Molndal. /Id# 202843|Vastra Gotalands Lan AlingsÃ¥s Lasarett /Id# 202074|University Hospital Zurich /Id# 202910|Ankara Univ Medical Faculty /Id# 167210|Kayseri Erciyes University Medical Fac /Id# 171291|Kyivska Oblast Medical Centre Of Ok!Clinic Of International Institute Of Clinical Trials /Id# 205482|Regional Clinical Hospital /Id# 203367|, Devon Rd&E Hospital /Id# 157587|Barnsley Hospital Nhs Foundati /Id# 202770|Ucsd /Id# 160452|Peak Gastroenterology Associat /Id# 165841|Medical Research Ctr Ct /Id# 160311|South Lake Pain Institute, Inc /Id# 162878|Emory University Hospital /Id# 160583|University Of Chicago /Id# 160521|Indiana University /Id# 167252|Univ Kansas Med Ctr /Id# 161868|Delricht Research /Id# 206815|Mgh Digestive Health Center /Id# 164255|Center For Digestive Health /Id# 160327|Mayo Clinic - Rochester /Id# 200458|Quality Clinical Research Inc. /Id# 167313|Columbia Univ Medical Center /Id# 161934|Carolinas Medical Center /Id# 158512|Plains Clinical Research Center, Llc /Id# 169732|The Ohio State University - Columbus /Id# 164714|Digestive Disease Specialists /Id# 170779|University Of Pennsylvania /Id# 166266|Gastroenterology Associates, P.A. /Id# 160472|Gastro One /Id# 160418|Inquest Clinical Research /Id# 165685|Val R. Hansen /Id# 163007|Virginia Mason Medical Center /Id# 160466",{"$nulls":3},"AbbVie Inc.","2018-10-17","2020-05-25T16:36:35.245","2020-05-26T17:10:42.972","NCT03398148"]
["5ecbf41311702c1b1b916a4f","NCT03398148","2018-11-06","AbbVie","ABBV","Recruiting","A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy","Risankizumab","IL23 Inhibitor","Yes","['Risankizumab']","No",null,"Phase 2/Phase 3",16,720,"Anticipated","2018-03-07","2020-09-23",{"$nulls":5},"The objectives of Sub-Study 1 are to evaluate the efficacy, safety, and pharmacokinetics of risankizumab as induction treatment in subjects with moderately to severely active ulcerative colitis (UC), and to identify the appropriate induction dose of risankizumab for further evaluation in Sub-Study 2.\n\nThe objective of Sub-Study 2 is to evaluate the efficacy and safety of risankizumab compared to placebo in inducing clinical remission in subjects with moderately to severely active UC.",null,"A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy","M16-067","Ulcerative Colitis (UC)","Colitis|Colitis, Ulcerative","Gastrointestinal Diseases","Gastrointestinal","Experimental|Placebo Comparator","Substudy 1, Induction 2: Double-blind Risankizumab Dose 2|Substudy 2, Induction 1: Open-label Risankizumab Dose 2|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 2, Induction 2: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 2, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 3|Substudy 2, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 1, Induction 1: Open-label Risankizumab Dose 3","Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection in Induction 2.|Participants randomized to receive risankizumab dose 2 administered by intravenous (IV) infusion.|Participants who received placebo with inadequate response in Induction 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.|Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 3 administered by subcutaneous (SC) injection in Induction 2.|Participants randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion.|Participants who received placebo with inadequate response in Induction 1 receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.|Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.|Participants randomized to receive risankizumab dose 3 administered by intravenous (IV) infusion.|Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.|Participants receive risankizumab dose 3 administered by intravenous (IV) infusion.","Drug","risankizumab SC|risankizumab IV|placebo for risankizumab","risankizumab subcutaneous (SC) injection|rizankizumab intravenous (IV) infusion|placebo for risankizumab","ABBV-066 | BI 655066","Substudy 1, Induction 2: Double-blind Risankizumab Dose 2|Substudy 2, Induction 1: Open-label Risankizumab Dose 2|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 2, Induction 2: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 2, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 3|Substudy 2, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 1, Induction 1: Open-label Risankizumab Dose 3","\n\n * Male or female aged >=18 to <= 80 years at the Baseline Visit. Where locally permissible, subjects 16 to < 18 years of age who meet the definition of Tanner stage 5 for development at the Baseline Visit\n * Confirmed diagnosis of ulcerative colitis (UC) for at least 3 months prior to Baseline.\n * Active UC as assessed by adapted Mayo Score\n * Demonstrated intolerance or inadequate response to one or more biologic therapies\n * Females must be postmenopausal for more than 2 years or surgically sterile or practicing specific forms of birth control.\n\n","\n\n * Subject with a current diagnosis of Crohn's disease (CD), inflammatory bowel disease-unclassified (IBD-U) or a history of radiation colitis or ischemic colitis.\n * Subject receiving prohibited medications and treatment.\n * Extent of inflammatory disease limited to the rectum as assessed by screening endoscopy.\n * Subject with currently known complications of UC (e.g., megacolon).",{"$nulls":4},"Actual","2018-01-12","Actual","Anticipated","2021-12-25","Anticipated","2018-10-01","2018-01-08","2018-01-08","2018-11-02","Yes","ABBV-066\nBI 655066","Interventional","Treatment","Parallel Assignment","Double (Participant, Investigator)","Randomized","16 Years","80 Years","All",null,"No","Yes\nAbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2016-004677-40","EudraCT Number","Percentage of participants with clinical remission per adapted Mayo Score at Week 12","Clinical remission per adapted Mayo Score.","Week 12","Percentage of participants achieving clinical remission per full Mayo Score at Week 12 in subjects with a full Mayo score of 6 to 12 at Baseline|Ulcerative Colitis Symptom Questionnaire (UC-SQ): Change from Baseline to Week 12|Inflammatory Bowel Disease Questionnaire (IBDQ): Change from Baseline to Week 12|Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue): Change from Baseline to Week 12|Percentage of participants achieving clinical response per adapted Mayo Score at week 12|Percentage of participants with endoscopic remission at Week 12|Percentage of participants achieving clinical response per partial adapted Mayo Score at week 4|Percentage of participants with mucosal healing at Week 12|36-Item Short Form Health Status Survey (SF-36): Change from Baseline to Week 12|Percentage of participants with hospitalization through Week 12|Percentage of participants with Ulcerative Colitis (UC)-related surgeries through Week 12|Percentage of participants with endoscopic improvement at Week 12","Clinical remission per full Mayo Score.|The US-SQ is a patient questionnaire to assess severity of Crohn's symptoms.|The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.|The FACIT-Fatigue is a validated tool that measures an individual's level of fatigue during their usual daily activities over the past week.|Clinical response per adapted Mayo Score.|Endoscopic remission per endoscopy subscore.|Clinical response per partial adapted Mayo Score (without endoscopy).|Mucosal healing defined as endoscopic and histologic remission.|The SF-36 is an indicator of overall health status.|Participants with an event that results in admission to the hospital.|Participants who underwent surgery related to UC.|Endoscopic improvement per endoscopy subscore.","Week 12|Baseline, Week 12|Week 4|12 weeks","abbvieclinicaltrials@abbvie.com","ABBVIE CALL CENTER","847.283.8955",{"$cut":{"chars":20675,"head":"Buenos Aires, Argentina, 1431 Instituto Medico Cer /Id# 168686Quilmes, Argentina, 1878 Sanatorio 9 De Julio S.A. /Id# 167780San Miguel De Tucuman, Argentina, 4000 Hopital Centenario /Id# 170898Santa Fe, Argentina, 2000|Graz, Austria, 8036 Lkh Salzburg And Paracelsus /Id# 200685Salzburg, Austria, 5020|St. PÃ¶lten, Niederoesterreich, Austria, 3100|Vienna, Wien, Austria, 1090|Brussels, Bruxelles-Capitale, Belgium, 1070 Cliniques Universitaires Saint Luc /Id# 200039Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200|Liege, Liege, Belgium, 4000|Gent, Oost-Vlaanderen, Belgium, 9000|Jette, Brussels, Belgium, 1090 Uz Leuven /Id# 170812Leuven, Belgium, 3000 Clinique St Joseph /Id# 200250Liege, Belgium, 4000 Az-Delta /Id# 200040Roeselare, Belgium, 8800 Chu Dinant Godinne - Ucl Namur /Id# 200254Yvoir, Belgium, 5530|Goiania, Goias, Brazil, 74535-170|Curitiba, Parana, Brazil, 80810-040|Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903|Botucatu, Sao Paulo, Brazil, 18618-686 Hospital Das Clinicas Da Faculdade De Medicina De RibeirÃ£o Preto - Usp /Id# 157660RibeirÃ£o Preto, Sao Paulo, Brazil, 14048-900 Faculdade De Medicina Do Abc /Id# 163995Santo AndrÃ©, Sao Paulo, Brazil, 09060-870 Kaiser Clinica E Hospital Dia /Id# 157680Sao Jose Do Rio Preto, Sao Paulo, Brazil, 15015-110|Sliven, Bulgaria, 8800 Ii Mhat - Sofia /Id# 200799Sofia, Bulgaria, 1202 Umhat Tsaritsa Joanna - Isul /Id# 207907Sofia, Bulgaria, 1527 Umhat Sv. 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Klinikum Graz /Id# 169053|Niederoesterreich UniversitÃ¤tsklinikum St.PÃ¶lten /Id# 169048|Wien Medical University Of Vienna /Id# 169050|Bruxelles-Capitale Cub Hospital Erasme /Id# 200252|Liege Chu De Liege /Id# 200253|Oost-Vlaanderen Uz Gent /Id# 200251|Uz Brussels /Id# 164176|Goias Instituto Goiano De Gastroenterologia /Id# 157679|Parana Hospital Nossa Senhora Das GraÃ§as /Id# 157671|Rio Grande Do Sul Hospital De Clinicas De Porto Alegre /Id# 157662|Sao Paulo Upeclin Fmb - Unesp /Id# 157690|Mbal \"Hadzhi Dimitar\" /Id# 207945|Alberta University Of Calgary /Id# 169111|British Columbia Fraser Clinical Trials Inc /Id# 169102|New Brunswick Qeii Health Sciences Centre /Id# 169107|Nova Scotia Iwk Health Center /Id# 169110|Ontario London Health Sciences Centre /Id# 169103|Quebec Hopital Charles-Lemoyne /Id# 169105|Hospital Las Higueras /Id# 167093|Region Metropolitana De Santiago Complejo Asistencial Dr. Sotero Del Rio /Id# 169385|ValparaÃ­so Centro De Investigaciones ClÃ­nicas ViÃ±a Del Mar /Id# 203607|Cundinamarca Corporacion Hospitalaria Juan Ciudad Sed|Instituto De Coloproctologia /Id# 158739|Grad Zagreb Klinicka Bolnica Dubrava Zagreb /Id# 157475|Klinicki Bolnicki Centar Split /Id# 157473|Osjecko-Baranjska Zupanija Klinicki Bolnicki Centar Osijek /Id# 157472|Hvidovre Hospital /Id# 202266|Midtjylland Aarhus University Hospital /Id# 200032|SjÃ¦lland Sjaellands Universitets Hospit /Id# 200033|Syddanmark Svendborg Sygehus, Sygehusenhe /Id# 200034|University Of Alexandria /Id# 200848|Alpes-Maritimes Chu De Nice-Hopital L'Archet Ii /Id# 171577|Chu Amiens Picardie - Site Sud /Id# 171576|Gironde HÃ´pital Haut-LÃ©vÃªque /Id# 171579|Hopital Beaujon /Id# 200092|Loire Chu De Saint Etienne - Hopital Nord /Id# 171580|Baden-Wuerttemberg Universitatsklinikum Mannheim /Id# 162035|Bayern Universitaetsklinikum Erlangen /Id# 159354|CharitÃ© UniversitÃ¤tsmedizin Campus Mitte /Id# 163688|Nordrhein-Westfalen Uniklinik Koln /Id# 164991|Schleswig-Holstein Univ Hosp Schleswig-Holstein /Id# 159360|Thueringen Universitaetsklinikum Ulm /Id# 164992|Attiki General Hospital Of Athens Laiko /Id# 206440|General Hospital Of Chest Diseases Of Athens \"Sotiria\" /Id# 170915|Baranya Mohacsi Korhaz /Id# 205347|Borsod-Abauj-Zemplen Miskolci Semmelweis Korhaz Es /Id# 201285|Heves Bugat Pal Korhaz /Id# 202528|Magyar Honvedseg Egeszsegugyi Kozpont /Id# 157329|Pest Obudai Egeszsegugyi Kozpont /Id# 201922|Hadarom Soroka Medical Center /Id# 171100|Rambam Medical Center /Id# 171101|Tel-Aviv Rabin Medical Center /Id# 167403|Yerushalayim Hadassah Ein Kerem Medical Ctr /Id# 171099|Calabria UniversitÃ  Di Catanzaro \"Magna Graecia\" /Id# 200125|Emilia-Romagna Ospedale Sant Orsola Malpighi /Id# 155611|Irccs Aou San Martino-Ist /Id# 164031|Lazio Policlinico Universitario Campus Bio-Medico /Id# 163992|Milano Istituto Clinico Humanitas /Id# 155610|Sicilia A.O. Per L'Emergenza Cannizzaro /Id# 164036|Verona Ospedale Classificato Equiparato Sacro Cuore-Don Calabria /Id# 164041|Aichi Aichi Medical University Hosp /Id# 164332|Chiba Toho University Sakura Medical Center /Id# 164254|Fukuoka Kurume University Hospital /Id# 164427|Gifu Gifu University Hospital /Id# 208081|Gunma National Hospital Organization Takasaki General Medical Center /Id# 164437|Hiroshima Nho Fukuyama Medical Center /Id# 164439|Hiroshima University Hospital /Id# 164426|Hokkaido Asahikawa Medical University Hospital /Id# 164433|Hyogo Aoyama Clinic /Id# 164425|Ishikawa Kanazawa University Ho /Id# 169224|Kanagawa Gokeikai Ofuna Chuo Hospital /Id# 169300|Mie Mie University Hospital /Id# 203633|Miyagi Tohoku University Hospital /Id# 164430|Nagasaki Nagasaki University Hospital /Id# 202674|Saitama Tokito Clinic /Id# 164253|Shiga Shiga Univ Med Science Hosp /Id# 164440|Tokyo Medical Hospital Of Tokyo Medical And Dental University /Id# 164258|Yamagata Yamagata University Hospital /Id# 171474|Riga East Clinical Univ Hosp /Id# 163802|Kaunas Hospital Of Lithuanian Univers /Id# 170714|Klaipeda Seamens Hospital /Id# 170847|Selangor Ukm Medical Centre /Id# 200635|Jalisco InvestigaciÃ³n BiomÃ©dica Para El Desarrollo De FÃ¡rmacos, S.A. De C.V. /Id# 203592|Jm Research /Id# 203593|Elisabeth Tweesteden Ziekenhuis /Id# 163767|Noord-Holland Academisch Medisch Centrum /Id# 157959|, Canterbury Christchurch Hospital /Id# 205342|Wellington Hospital (Capital And Coast District Health Board) /Id# 205343|Kujawsko-Pomorskie Szpital Uniwersytecki Nr 2 Im. Dr J.Biziela W Bydgoszczy /Id# 170599|Malopolskie Centrum Medyczne Plejady /Id# 170633|Mazowieckie Centrum Zdrowia Mdm /Id# 170597|Chuc- Centro Hospitalar E Univ /Id# 166054|Faro Centro Hospitalar Do Algarve - Hospital De PortimÃ£o /Id# 166551|Lisboa Centro Hosp De Lisboa Central /Id# 165582|Setubal Hospital Garcia De Orta, E.P.E /Id# 165583|Institutul Clinic Fundeni /Id# 171264|Southern California Res. Ctr. /Id# 169660|/Id# 200152|Sumadijski Okrug Clinical Center Kragujevac /Id# 156913|Fn S Poliklinikou F.D. Rooseve /Id# 164347|, Free State Farmovs Integrated Research Solutions /Id# 207537|, Gauteng Wits Clinical Research Site /Id# 171136|, Western Cape Mediclinic Constantiaberg /Id# 171137|Dr Jp Wright /Id# 171138|Hospital Universitario Parc Tauli /Id# 159461|Pontevedra Hospital Alvaro Cunqueiro /Id# 167360|Su Molndal. /Id# 202843|Vastra Gotalands Lan AlingsÃ¥s Lasarett /Id# 202074|University Hospital Zurich /Id# 202910|Ankara Univ Medical Faculty /Id# 167210|Kayseri Erciyes University Medical Fac /Id# 171291|Kyivska Oblast Medical Centre Of Ok!Clinic Of International Institute Of Clinical Trials /Id# 205482|Regional Clinical Hospital /Id# 203367|, Devon Rd&E Hospital /Id# 157587|Barnsley Hospital Nhs Foundati /Id# 202770|Ucsd /Id# 160452|Peak Gastroenterology Associat /Id# 165841|Medical Research Ctr Ct /Id# 160311|South Lake Pain Institute, Inc /Id# 162878|Emory University Hospital /Id# 160583|University Of Chicago /Id# 160521|Indiana University /Id# 167252|Univ Kansas Med Ctr /Id# 161868|Delricht Research /Id# 206815|Mgh Digestive Health Center /Id# 164255|Center For Digestive Health /Id# 160327|Mayo Clinic - Rochester /Id# 200458|Quality Clinical Research Inc. /Id# 167313|Columbia Univ Medical Center /Id# 161934|Carolinas Medical Center /Id# 158512|Plains Clinical Research Center, Llc /Id# 169732|Cleveland Clinic Foundation /Id# 209232|Digestive Disease Specialists /Id# 170779|University Of Pennsylvania /Id# 166266|Gastroenterology Associates, P.A. /Id# 160472|Gastro One /Id# 160418|Inquest Clinical Research /Id# 165685|Hp Clinical Research /Id# 163007|Virginia Mason Medical Center /Id# 160466",{"$nulls":3},"AbbVie Inc.","2018-11-02","2020-05-25T16:36:35.510","2020-05-26T17:10:42.972","NCT03398148"]
["5ecbf413e2561b1b11905d39","NCT03398148","2018-11-26","AbbVie","ABBV","Recruiting","A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy","Risankizumab","IL23 Inhibitor","Yes","['Risankizumab']","No",null,"Phase 2/Phase 3",16,720,"Anticipated","2018-03-07","2020-09-23",{"$nulls":5},"The objectives of Sub-Study 1 are to evaluate the efficacy, safety, and pharmacokinetics of risankizumab as induction treatment in subjects with moderately to severely active ulcerative colitis (UC), and to identify the appropriate induction dose of risankizumab for further evaluation in Sub-Study 2.\n\nThe objective of Sub-Study 2 is to evaluate the efficacy and safety of risankizumab compared to placebo in inducing clinical remission in subjects with moderately to severely active UC.",null,"A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy","M16-067","Ulcerative Colitis (UC)","Colitis|Colitis, Ulcerative","Gastrointestinal Diseases","Gastrointestinal","Experimental|Placebo Comparator","Substudy 1, Induction 2: Double-blind Risankizumab Dose 2|Substudy 2, Induction 1: Open-label Risankizumab Dose 2|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 2, Induction 2: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 2, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 3|Substudy 2, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 1, Induction 1: Open-label Risankizumab Dose 3","Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection in Induction 2.|Participants randomized to receive risankizumab dose 2 administered by intravenous (IV) infusion.|Participants who received placebo with inadequate response in Induction 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.|Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 3 administered by subcutaneous (SC) injection in Induction 2.|Participants randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion.|Participants who received placebo with inadequate response in Induction 1 receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.|Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.|Participants randomized to receive risankizumab dose 3 administered by intravenous (IV) infusion.|Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.|Participants receive risankizumab dose 3 administered by intravenous (IV) infusion.","Drug","risankizumab SC|risankizumab IV|placebo for risankizumab","risankizumab subcutaneous (SC) injection|risankizumab intravenous (IV) infusion|placebo for risankizumab","ABBV-066 | BI 655066","Substudy 1, Induction 2: Double-blind Risankizumab Dose 2|Substudy 2, Induction 1: Open-label Risankizumab Dose 2|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 2, Induction 2: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 2, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 3|Substudy 2, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 1, Induction 1: Open-label Risankizumab Dose 3","\n\n * Male or female aged >=18 to <= 80 years at the Baseline Visit. Where locally permissible, subjects 16 to < 18 years of age who meet the definition of Tanner stage 5 for development at the Baseline Visit\n * Confirmed diagnosis of ulcerative colitis (UC) for at least 3 months prior to Baseline.\n * Active UC as assessed by adapted Mayo Score\n * Demonstrated intolerance or inadequate response to one or more biologic therapies\n * Females must be postmenopausal for more than 2 years or surgically sterile or practicing specific forms of birth control.\n\n","\n\n * Subject with a current diagnosis of Crohn's disease (CD), inflammatory bowel disease-unclassified (IBD-U) or a history of radiation colitis or ischemic colitis.\n * Subject receiving prohibited medications and treatment.\n * Extent of inflammatory disease limited to the rectum as assessed by screening endoscopy.\n * Subject with currently known complications of UC (e.g., megacolon).",{"$nulls":4},"Actual","2018-01-12","Actual","Anticipated","2021-12-25","Anticipated","2018-11-01","2018-01-08","2018-01-08","2018-11-21","Yes","ABBV-066\nBI 655066","Interventional","Treatment","Parallel Assignment","Double (Participant, Investigator)","Randomized","16 Years","80 Years","All",null,"No","Yes\nAbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2016-004677-40","EudraCT Number","Percentage of participants with clinical remission per adapted Mayo Score at Week 12","Clinical remission per adapted Mayo Score.","Week 12","Percentage of participants achieving clinical remission per full Mayo Score at Week 12 in subjects with a full Mayo score of 6 to 12 at Baseline|Ulcerative Colitis Symptom Questionnaire (UC-SQ): Change from Baseline to Week 12|Inflammatory Bowel Disease Questionnaire (IBDQ): Change from Baseline to Week 12|Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue): Change from Baseline to Week 12|Percentage of participants achieving clinical response per adapted Mayo Score at week 12|Percentage of participants with endoscopic remission at Week 12|Percentage of participants achieving clinical response per partial adapted Mayo Score at week 4|Percentage of participants with mucosal healing at Week 12|36-Item Short Form Health Status Survey (SF-36): Change from Baseline to Week 12|Percentage of participants with hospitalization through Week 12|Percentage of participants with Ulcerative Colitis (UC)-related surgeries through Week 12|Percentage of participants with endoscopic improvement at Week 12","Clinical remission per full Mayo Score.|The US-SQ is a patient questionnaire to assess severity of Crohn's symptoms.|The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.|The FACIT-Fatigue is a validated tool that measures an individual's level of fatigue during their usual daily activities over the past week.|Clinical response per adapted Mayo Score.|Endoscopic remission per endoscopy subscore.|Clinical response per partial adapted Mayo Score (without endoscopy).|Mucosal healing defined as endoscopic and histologic remission.|The SF-36 is an indicator of overall health status.|Participants with an event that results in admission to the hospital.|Participants who underwent surgery related to UC.|Endoscopic improvement per endoscopy subscore.","Week 12|Baseline, Week 12|Week 4|12 weeks","abbvieclinicaltrials@abbvie.com","ABBVIE CALL CENTER","847.283.8955",{"$cut":{"chars":20900,"head":"Buenos Aires, Argentina, 1431 Instituto Medico Cer /Id# 168686Quilmes, Argentina, 1878 Sanatorio 9 De Julio S.A. /Id# 167780San Miguel De Tucuman, Argentina, 4000 Hopital Centenario /Id# 170898Santa Fe, Argentina, 2000|Graz, Austria, 8036 Lkh Salzburg And Paracelsus /Id# 200685Salzburg, Austria, 5020|St. PÃ¶lten, Niederoesterreich, Austria, 3100|Vienna, Wien, Austria, 1090|Brussels, Bruxelles-Capitale, Belgium, 1070 Cliniques Universitaires Saint Luc /Id# 200039Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200|Liege, Liege, Belgium, 4000|Gent, Oost-Vlaanderen, Belgium, 9000|Jette, Brussels, Belgium, 1090 Uz Leuven /Id# 170812Leuven, Belgium, 3000 Clinique St Joseph /Id# 200250Liege, Belgium, 4000 Az-Delta /Id# 200040Roeselare, Belgium, 8800 Chu Dinant Godinne - Ucl Namur /Id# 200254Yvoir, Belgium, 5530|Goiania, Goias, Brazil, 74535-170|Curitiba, Parana, Brazil, 80810-040|Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903|Botucatu, Sao Paulo, Brazil, 18618-686 Hospital Das Clinicas Da Faculdade De Medicina De RibeirÃ£o Preto - Usp /Id# 157660RibeirÃ£o Preto, Sao Paulo, Brazil, 14048-900 Faculdade De Medicina Do Abc /Id# 163995Santo AndrÃ©, Sao Paulo, Brazil, 09060-870 Kaiser Clinica E Hospital Dia /Id# 157680Sao Jose Do Rio Preto, Sao Paulo, Brazil, 15015-110|Sliven, Bulgaria, 8800 Ii Mhat - Sofia /Id# 200799Sofia, Bulgaria, 1202 Umhat Tsaritsa Joanna - Isul /Id# 207907Sofia, Bulgaria, 1527 Umhat Sv. 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Klinikum Graz /Id# 169053|Niederoesterreich UniversitÃ¤tsklinikum St.PÃ¶lten /Id# 169048|Wien Medical University Of Vienna /Id# 169050|Bruxelles-Capitale Cub Hospital Erasme /Id# 200252|Liege Chu De Liege /Id# 200253|Oost-Vlaanderen Uz Gent /Id# 200251|Uz Brussels /Id# 164176|Goias Instituto Goiano De Gastroenterologia /Id# 157679|Parana Hospital Nossa Senhora Das GraÃ§as /Id# 157671|Rio Grande Do Sul Hospital De Clinicas De Porto Alegre /Id# 157662|Sao Paulo Upeclin Fmb - Unesp /Id# 157690|Mbal \"Hadzhi Dimitar\" /Id# 207945|Alberta University Of Calgary /Id# 169111|British Columbia Fraser Clinical Trials Inc /Id# 169102|New Brunswick Qeii Health Sciences Centre /Id# 169107|Nova Scotia Iwk Health Center /Id# 169110|Ontario London Health Sciences Centre /Id# 169103|Quebec Hopital Charles-Lemoyne /Id# 169105|Hospital Las Higueras /Id# 167093|Region Metropolitana De Santiago Complejo Asistencial Dr. Sotero Del Rio /Id# 169385|ValparaÃ­so Centro De Investigaciones ClÃ­nicas ViÃ±a Del Mar /Id# 203607|Instituto De Coloproctologia /Id# 158739|Grad Zagreb Klinicka Bolnica Dubrava Zagreb /Id# 157475|Klinicki Bolnicki Centar Split /Id# 157473|Osjecko-Baranjska Zupanija Klinicki Bolnicki Centar Osijek /Id# 157472|Hvidovre Hospital /Id# 202266|SjÃ¦lland Sjaellands Universitets Hospit /Id# 200033|Syddanmark Svendborg Sygehus, Sygehusenhe /Id# 200034|University Of Alexandria /Id# 200848|Alpes-Maritimes Chu De Nice-Hopital L'Archet Ii /Id# 171577|Chu Amiens Picardie - Site Sud /Id# 171576|Gironde HÃ´pital Haut-LÃ©vÃªque /Id# 171579|Hopital Beaujon /Id# 200092|Loire Chu De Saint Etienne - Hopital Nord /Id# 171580|Baden-Wuerttemberg Universitatsklinikum Mannheim /Id# 162035|Bayern Universitaetsklinikum Erlangen /Id# 159354|CharitÃ© UniversitÃ¤tsmedizin Campus Mitte /Id# 163688|Nordrhein-Westfalen Uniklinik Koln /Id# 164991|Schleswig-Holstein Univ Hosp Schleswig-Holstein /Id# 159360|Thueringen Universitaetsklinikum Ulm /Id# 164992|Attiki General Hospital Of Athens Laiko /Id# 206440|General Hospital Of Chest Diseases Of Athens \"Sotiria\" /Id# 170915|Baranya Mohacsi Korhaz /Id# 205347|Borsod-Abauj-Zemplen Miskolci Semmelweis Korhaz Es /Id# 201285|Heves Bugat Pal Korhaz /Id# 202528|Magyar Honvedseg Egeszsegugyi Kozpont /Id# 157329|Pest Obudai Egeszsegugyi Kozpont /Id# 201922|Hadarom Soroka Medical Center /Id# 171100|Rambam Medical Center /Id# 171101|Tel-Aviv Rabin Medical Center /Id# 167403|Yerushalayim Hadassah Ein Kerem Medical Ctr /Id# 171099|Calabria UniversitÃ  Di Catanzaro \"Magna Graecia\" /Id# 200125|Emilia-Romagna Ospedale Sant Orsola Malpighi /Id# 155611|Irccs Aou San Martino-Ist /Id# 164031|Lazio Policlinico Universitario Campus Bio-Medico /Id# 163992|Milano Istituto Clinico Humanitas /Id# 155610|Sicilia A.O. Per L'Emergenza Cannizzaro /Id# 164036|Verona Ospedale Classificato Equiparato Sacro Cuore-Don Calabria /Id# 164041|Aichi Aichi Medical University Hosp /Id# 164332|Chiba Toho University Sakura Medical Center /Id# 164254|Fukuoka Kurume University Hospital /Id# 164427|Gifu Gifu University Hospital /Id# 208081|Gunma National Hospital Organization Takasaki General Medical Center /Id# 164437|Hiroshima Nho Fukuyama Medical Center /Id# 164439|Hiroshima University Hospital /Id# 164426|Hokkaido Asahikawa Medical University Hospital /Id# 164433|Hyogo Aoyama Clinic /Id# 164425|Ishikawa Kanazawa University Ho /Id# 169224|Kanagawa Gokeikai Ofuna Chuo Hospital /Id# 169300|Mie Mie University Hospital /Id# 203633|Miyagi Tohoku University Hospital /Id# 164430|Nagasaki Nagasaki University Hospital /Id# 202674|Saitama Tokito Clinic /Id# 164253|Shiga Shiga Univ Med Science Hosp /Id# 164440|Tokyo Medical Hospital Of Tokyo Medical And Dental University /Id# 164258|Yamagata Yamagata University Hospital /Id# 171474|Riga East Clinical Univ Hosp /Id# 163802|Kaunas Hospital Of Lithuanian Univers /Id# 170714|Klaipeda Seamens Hospital /Id# 170847|Selangor Ukm Medical Centre /Id# 200635|Jalisco InvestigaciÃ³n BiomÃ©dica Para El Desarrollo De FÃ¡rmacos, S.A. De C.V. /Id# 203592|Jm Research /Id# 203593|Elisabeth Tweesteden Ziekenhuis /Id# 163767|Noord-Holland Academisch Medisch Centrum /Id# 157959|, Canterbury Christchurch Hospital /Id# 205342|Wellington Hospital (Capital And Coast District Health Board) /Id# 205343|Kujawsko-Pomorskie Szpital Uniwersytecki Nr 2 Im. Dr J.Biziela W Bydgoszczy /Id# 170599|Malopolskie Centrum Medyczne Plejady /Id# 170633|Mazowieckie Centrum Zdrowia Mdm /Id# 170597|Chuc- Centro Hospitalar E Univ /Id# 166054|Faro Centro Hospitalar Do Algarve - Hospital De PortimÃ£o /Id# 166551|Lisboa Centro Hosp De Lisboa Central /Id# 165582|Setubal Hospital Garcia De Orta, E.P.E /Id# 165583|Institutul Clinic Fundeni /Id# 171264|Southern California Res. Ctr. /Id# 169660|/Id# 200152|Sumadijski Okrug Clinical Center Kragujevac /Id# 156913|Fn S Poliklinikou F.D. Rooseve /Id# 164347|, Free State Farmovs Integrated Research Solutions /Id# 207537|, Gauteng Wits Clinical Research Site /Id# 171136|, Western Cape Mediclinic Constantiaberg /Id# 171137|Dr Jp Wright /Id# 171138|Hospital Universitario Parc Tauli /Id# 159461|Pontevedra Hospital Alvaro Cunqueiro /Id# 167360|Su Molndal. /Id# 202843|Vastra Gotalands Lan AlingsÃ¥s Lasarett /Id# 202074|University Hospital Zurich /Id# 202910|Ankara Univ Medical Faculty /Id# 167210|Kayseri Erciyes University Medical Fac /Id# 171291|Kyivska Oblast Medical Centre Of Ok!Clinic Of International Institute Of Clinical Trials /Id# 205482|Regional Clinical Hospital /Id# 203367|, Devon Rd&E Hospital /Id# 157587|Barnsley Hospital Nhs Foundation Trust /Id# 202770|Ucsd /Id# 160452|Peak Gastroenterology Associat /Id# 165841|Medical Research Ctr Ct /Id# 160311|South Lake Pain Institute, Inc /Id# 162878|Emory University Hospital /Id# 160583|University Of Chicago /Id# 160521|Indiana University /Id# 167252|Cotton-O'Neil Clinical Res Ctr /Id# 160412|Delricht Research /Id# 206815|Mgh Digestive Health Center /Id# 164255|Center For Digestive Health /Id# 160327|Mayo Clinic - Rochester /Id# 200458|Quality Clinical Research Inc. /Id# 167313|Columbia Univ Medical Center /Id# 161934|Carolinas Medical Center /Id# 158512|Plains Clinical Research Center, Llc /Id# 169732|Cleveland Clinic Foundation /Id# 209232|Digestive Disease Specialists /Id# 170779|University Of Pennsylvania /Id# 166266|Gastroenterology Associates, P.A. /Id# 160472|Gastro One /Id# 160418|Inquest Clinical Research /Id# 165685|Hp Clinical Research /Id# 163007|Virginia Mason Medical Center /Id# 160466",{"$nulls":3},"AbbVie Inc.","2018-11-21","2020-05-25T16:36:35.224","2020-05-26T17:10:42.972","NCT03398148"]
["5ecbf414fe30261b1a04823f","NCT03398148","2018-11-29","AbbVie","ABBV","Recruiting","A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy","Risankizumab","IL23 Inhibitor","Yes","['Risankizumab']","No",null,"Phase 2/Phase 3",16,720,"Anticipated","2018-03-07","2020-09-23",{"$nulls":5},"The objectives of Sub-Study 1 are to evaluate the efficacy, safety, and pharmacokinetics of risankizumab as induction treatment in subjects with moderately to severely active ulcerative colitis (UC), and to identify the appropriate induction dose of risankizumab for further evaluation in Sub-Study 2.\n\nThe objective of Sub-Study 2 is to evaluate the efficacy and safety of risankizumab compared to placebo in inducing clinical remission in subjects with moderately to severely active UC.",null,"A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy","M16-067","Ulcerative Colitis (UC)","Colitis|Colitis, Ulcerative","Gastrointestinal Diseases","Gastrointestinal","Experimental|Placebo Comparator","Substudy 1, Induction 2: Double-blind Risankizumab Dose 2|Substudy 2, Induction 1: Open-label Risankizumab Dose 2|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 2, Induction 2: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 2, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 3|Substudy 2, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 1, Induction 1: Open-label Risankizumab Dose 3","Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection in Induction 2.|Participants randomized to receive risankizumab dose 2 administered by intravenous (IV) infusion.|Participants who received placebo with inadequate response in Induction 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.|Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 3 administered by subcutaneous (SC) injection in Induction 2.|Participants randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion.|Participants who received placebo with inadequate response in Induction 1 receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.|Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.|Participants randomized to receive risankizumab dose 3 administered by intravenous (IV) infusion.|Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.|Participants receive risankizumab dose 3 administered by intravenous (IV) infusion.","Drug","risankizumab SC|risankizumab IV|placebo for risankizumab","risankizumab subcutaneous (SC) injection|risankizumab intravenous (IV) infusion|placebo for risankizumab","ABBV-066 | BI 655066","Substudy 1, Induction 2: Double-blind Risankizumab Dose 2|Substudy 2, Induction 1: Open-label Risankizumab Dose 2|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 2, Induction 2: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 2, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 3|Substudy 2, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 1, Induction 1: Open-label Risankizumab Dose 3","\n\n * Male or female aged >=18 to <= 80 years at the Baseline Visit. Where locally permissible, subjects 16 to < 18 years of age who meet the definition of Tanner stage 5 for development at the Baseline Visit\n * Confirmed diagnosis of ulcerative colitis (UC) for at least 3 months prior to Baseline.\n * Active UC as assessed by adapted Mayo Score\n * Demonstrated intolerance or inadequate response to one or more biologic therapies\n * Females must be postmenopausal for more than 2 years or surgically sterile or practicing specific forms of birth control.\n\n","\n\n * Subject with a current diagnosis of Crohn's disease (CD), inflammatory bowel disease-unclassified (IBD-U) or a history of radiation colitis or ischemic colitis.\n * Subject receiving prohibited medications and treatment.\n * Extent of inflammatory disease limited to the rectum as assessed by screening endoscopy.\n * Subject with currently known complications of UC (e.g., megacolon).",{"$nulls":4},"Actual","2018-01-12","Actual","Anticipated","2021-12-25","Anticipated","2018-11-01","2018-01-08","2018-01-08","2018-11-27","Yes","ABBV-066\nBI 655066","Interventional","Treatment","Parallel Assignment","Double (Participant, Investigator)","Randomized","16 Years","80 Years","All",null,"No","Yes\nAbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2016-004677-40","EudraCT Number","Percentage of participants with clinical remission per adapted Mayo Score at Week 12","Clinical remission per adapted Mayo Score.","Week 12","Percentage of participants achieving clinical remission per full Mayo Score at Week 12 in subjects with a full Mayo score of 6 to 12 at Baseline|Ulcerative Colitis Symptom Questionnaire (UC-SQ): Change from Baseline to Week 12|Inflammatory Bowel Disease Questionnaire (IBDQ): Change from Baseline to Week 12|Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue): Change from Baseline to Week 12|Percentage of participants achieving clinical response per adapted Mayo Score at week 12|Percentage of participants with endoscopic remission at Week 12|Percentage of participants achieving clinical response per partial adapted Mayo Score at week 4|Percentage of participants with mucosal healing at Week 12|36-Item Short Form Health Status Survey (SF-36): Change from Baseline to Week 12|Percentage of participants with hospitalization through Week 12|Percentage of participants with Ulcerative Colitis (UC)-related surgeries through Week 12|Percentage of participants with endoscopic improvement at Week 12","Clinical remission per full Mayo Score.|The US-SQ is a patient questionnaire to assess severity of Crohn's symptoms.|The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.|The FACIT-Fatigue is a validated tool that measures an individual's level of fatigue during their usual daily activities over the past week.|Clinical response per adapted Mayo Score.|Endoscopic remission per endoscopy subscore.|Clinical response per partial adapted Mayo Score (without endoscopy).|Mucosal healing defined as endoscopic and histologic remission.|The SF-36 is an indicator of overall health status.|Participants with an event that results in admission to the hospital.|Participants who underwent surgery related to UC.|Endoscopic improvement per endoscopy subscore.","Week 12|Baseline, Week 12|Week 4|12 weeks","abbvieclinicaltrials@abbvie.com","ABBVIE CALL CENTER","847.283.8955",{"$cut":{"chars":21191,"head":"Buenos Aires, Argentina, 1431 Instituto Medico Cer /Id# 168686Quilmes, Argentina, 1878 Sanatorio 9 De Julio S.A. /Id# 167780San Miguel De Tucuman, Argentina, 4000|Rosario, Santa Fe, Argentina, 2000|Graz, Austria, 8036 Lkh Salzburg And Paracelsus /Id# 200685Salzburg, Austria, 5020|St. PÃ¶lten, Niederoesterreich, Austria, 3100|Vienna, Wien, Austria, 1090|Brussels, Bruxelles-Capitale, Belgium, 1070 Cliniques Universitaires Saint Luc /Id# 200039Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200|Liege, Liege, Belgium, 4000|Gent, Oost-Vlaanderen, Belgium, 9000|Jette, Brussels, Belgium, 1090 Uz Leuven /Id# 170812Leuven, Belgium, 3000 Clinique St Joseph /Id# 200250Liege, Belgium, 4000 Az-Delta /Id# 200040Roeselare, Belgium, 8800 Chu Dinant Godinne - Ucl Namur /Id# 200254Yvoir, Belgium, 5530|Goiania, Goias, Brazil, 74535-170|Curitiba, Parana, Brazil, 80810-040|Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903|Botucatu, Sao Paulo, Brazil, 18618-686 Hospital Das Clinicas Da Faculdade De Medicina De RibeirÃ£o Preto - Usp /Id# 157660RibeirÃ£o Preto, Sao Paulo, Brazil, 14048-900 Faculdade De Medicina Do Abc /Id# 163995Santo AndrÃ©, Sao Paulo, Brazil, 09060-870 Kaiser Clinica E Hospital Dia /Id# 157680Sao Jose Do Rio Preto, Sao Paulo, Brazil, 15015-110|Sliven, Bulgaria, 8800 Ii Mhat - Sofia /Id# 200799Sofia, Bulgaria, 1202 Umhat Tsaritsa Joanna - Isul /Id# 209977Sofia, Bulgaria, 1527 Umhat Sv. 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Klinikum Graz /Id# 169053|Niederoesterreich UniversitÃ¤tsklinikum St.PÃ¶lten /Id# 169048|Wien Medical University Of Vienna /Id# 169050|Bruxelles-Capitale Cub Hospital Erasme /Id# 200252|Liege Chu De Liege /Id# 200253|Oost-Vlaanderen Uz Gent /Id# 200251|Uz Brussels /Id# 164176|Goias Instituto Goiano De Gastroenterologia /Id# 157679|Parana Hospital Nossa Senhora Das GraÃ§as /Id# 157671|Rio Grande Do Sul Hospital De Clinicas De Porto Alegre /Id# 157662|Sao Paulo Upeclin Fmb - Unesp /Id# 157690|Mbal \"Hadzhi Dimitar\" /Id# 207945|Alberta University Of Calgary /Id# 169111|British Columbia Fraser Clinical Trials Inc /Id# 169102|New Brunswick Qeii Health Sciences Centre /Id# 169107|Nova Scotia Iwk Health Center /Id# 169110|Ontario London Health Sciences Centre /Id# 169103|Quebec Hopital Charles-Lemoyne /Id# 169105|Hospital Las Higueras /Id# 167093|Region Metropolitana De Santiago Complejo Asistencial Dr. Sotero Del Rio /Id# 169385|ValparaÃ­so Centro De Investigaciones ClÃ­nicas ViÃ±a Del Mar /Id# 203607|Instituto De Coloproctologia /Id# 158739|Grad Zagreb Klinicka Bolnica Dubrava Zagreb /Id# 157475|Klinicki Bolnicki Centar Split /Id# 157473|Osjecko-Baranjska Zupanija Klinicki Bolnicki Centar Osijek /Id# 157472|Hvidovre Hospital /Id# 202266|SjÃ¦lland Sjaellands Universitets Hospit /Id# 200033|Syddanmark Svendborg Sygehus, Sygehusenhe /Id# 200034|University Of Alexandria /Id# 200848|Alpes-Maritimes Chu De Nice-Hopital L'Archet Ii /Id# 171577|Chu Amiens Picardie - Site Sud /Id# 171576|Gironde HÃ´pital Haut-LÃ©vÃªque /Id# 171579|Hopital Beaujon /Id# 200092|Loire Chu De Saint Etienne - Hopital Nord /Id# 171580|Baden-Wuerttemberg Universitatsklinikum Mannheim /Id# 162035|Bayern Universitaetsklinikum Erlangen /Id# 159354|CharitÃ© UniversitÃ¤tsmedizin Campus Mitte /Id# 163688|Nordrhein-Westfalen Uniklinik Koln /Id# 164991|Schleswig-Holstein Univ Hosp Schleswig-Holstein /Id# 159360|Thueringen Universitaetsklinikum Ulm /Id# 164992|Attiki General Hospital Of Athens Laiko /Id# 206440|General Hospital Of Chest Diseases Of Athens \"Sotiria\" /Id# 170915|Baranya Mohacsi Korhaz /Id# 205347|Borsod-Abauj-Zemplen Miskolci Semmelweis Korhaz Es /Id# 201285|Heves Bugat Pal Korhaz /Id# 202528|Magyar Honvedseg Egeszsegugyi Kozpont /Id# 157329|Pest Obudai Egeszsegugyi Kozpont /Id# 201922|Hadarom Soroka Medical Center /Id# 171100|Rambam Medical Center /Id# 171101|Tel-Aviv Rabin Medical Center /Id# 167403|Yerushalayim Hadassah Ein Kerem Medical Ctr /Id# 171099|Calabria UniversitÃ  Di Catanzaro \"Magna Graecia\" /Id# 200125|Emilia-Romagna Ospedale Sant Orsola Malpighi /Id# 155611|Irccs Aou San Martino-Ist /Id# 164031|Lazio Policlinico Universitario Campus Bio-Medico /Id# 163992|Milano Istituto Clinico Humanitas /Id# 155610|Sicilia A.O. 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Rooseve /Id# 164347|, Free State Farmovs Integrated Research Solutions /Id# 207537|, Gauteng Wits Clinical Research Site /Id# 171136|, Western Cape Mediclinic Constantiaberg /Id# 171137|Dr Jp Wright /Id# 171138|Hospital Universitario Parc Tauli /Id# 159461|Pontevedra Hospital Alvaro Cunqueiro /Id# 167360|Su Molndal. /Id# 202843|Vastra Gotalands Lan AlingsÃ¥s Lasarett /Id# 202074|University Hospital Zurich /Id# 202910|Ankara Univ Medical Faculty /Id# 167210|Kayseri Erciyes University Medical Fac /Id# 171291|Kyivska Oblast Medical Centre Of Ok!Clinic Of International Institute Of Clinical Trials /Id# 205482|Regional Clinical Hospital /Id# 203367|, Devon Rd&E Hospital /Id# 157587|Barnsley Hospital Nhs Foundation Trust /Id# 202770|Ucsd /Id# 160452|Peak Gastroenterology Associat /Id# 165841|Medical Research Ctr Ct /Id# 160311|South Lake Pain Institute, Inc /Id# 162878|Emory University Hospital /Id# 160583|University Of Chicago /Id# 160521|Indiana University /Id# 167252|Cotton-O'Neil Clinical Res Ctr /Id# 160412|Delricht Research /Id# 206815|Mgh Digestive Health Center /Id# 164255|Center For Digestive Health /Id# 160327|Mayo Clinic - Rochester /Id# 200458|Quality Clinical Research Inc. /Id# 167313|Columbia Univ Medical Center /Id# 161934|Carolinas Medical Center /Id# 158512|Plains Clinical Research Center, Llc /Id# 169732|Cleveland Clinic Foundation /Id# 209232|Digestive Disease Specialists /Id# 170779|University Of Pennsylvania /Id# 166266|Gastroenterology Associates, P.A. /Id# 160472|Gastro One /Id# 160418|Inquest Clinical Research /Id# 165685|Hp Clinical Research /Id# 163007|Virginia Mason Medical Center /Id# 160466",{"$nulls":3},"AbbVie Inc.","2018-11-27","2020-05-25T16:36:36.025","2020-05-26T17:10:42.972","NCT03398148"]
["5ecbf413e2561b1b11905d3a","NCT03398148","2018-12-10","AbbVie","ABBV","Recruiting","A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy","Risankizumab","IL23 Inhibitor","Yes","['Risankizumab']","No",null,"Phase 2/Phase 3",16,720,"Anticipated","2018-03-07","2020-09-23",{"$nulls":5},"The objectives of Sub-Study 1 are to evaluate the efficacy, safety, and pharmacokinetics of risankizumab as induction treatment in subjects with moderately to severely active ulcerative colitis (UC), and to identify the appropriate induction dose of risankizumab for further evaluation in Sub-Study 2.\n\nThe objective of Sub-Study 2 is to evaluate the efficacy and safety of risankizumab compared to placebo in inducing clinical remission in subjects with moderately to severely active UC.",null,"A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy","M16-067","Ulcerative Colitis (UC)","Colitis|Colitis, Ulcerative","Gastrointestinal Diseases","Gastrointestinal","Experimental|Placebo Comparator","Substudy 1, Induction 2: Double-blind Risankizumab Dose 2|Substudy 2, Induction 1: Open-label Risankizumab Dose 2|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 2, Induction 2: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 2, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 3|Substudy 2, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 1, Induction 1: Open-label Risankizumab Dose 3","Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection in Induction 2.|Participants randomized to receive risankizumab dose 2 administered by intravenous (IV) infusion.|Participants who received placebo with inadequate response in Induction 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.|Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 3 administered by subcutaneous (SC) injection in Induction 2.|Participants randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion.|Participants who received placebo with inadequate response in Induction 1 receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.|Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.|Participants randomized to receive risankizumab dose 3 administered by intravenous (IV) infusion.|Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.|Participants receive risankizumab dose 3 administered by intravenous (IV) infusion.","Drug","risankizumab SC|risankizumab IV|placebo for risankizumab","risankizumab subcutaneous (SC) injection|risankizumab intravenous (IV) infusion|placebo for risankizumab","ABBV-066 | BI 655066","Substudy 1, Induction 2: Double-blind Risankizumab Dose 2|Substudy 2, Induction 1: Open-label Risankizumab Dose 2|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 2, Induction 2: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 2, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 3|Substudy 2, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 1, Induction 1: Open-label Risankizumab Dose 3","\n\n * Male or female aged >=18 to <= 80 years at the Baseline Visit. Where locally permissible, subjects 16 to < 18 years of age who meet the definition of Tanner stage 5 for development at the Baseline Visit\n * Confirmed diagnosis of ulcerative colitis (UC) for at least 3 months prior to Baseline.\n * Active UC as assessed by adapted Mayo Score\n * Demonstrated intolerance or inadequate response to one or more biologic therapies\n * Females must be postmenopausal for more than 2 years or surgically sterile or practicing specific forms of birth control.\n\n","\n\n * Subject with a current diagnosis of Crohn's disease (CD), inflammatory bowel disease-unclassified (IBD-U) or a history of radiation colitis or ischemic colitis.\n * Subject receiving prohibited medications and treatment.\n * Extent of inflammatory disease limited to the rectum as assessed by screening endoscopy.\n * Subject with currently known complications of UC (e.g., megacolon).",{"$nulls":4},"Actual","2018-01-12","Actual","Anticipated","2022-08-29","Anticipated","2018-12-01","2018-01-08","2018-01-08","2018-12-07","Yes","ABBV-066\nBI 655066","Interventional","Treatment","Parallel Assignment","Double (Participant, Investigator)","Randomized","16 Years","80 Years","All",null,"No","Yes\nAbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2016-004677-40","EudraCT Number","Percentage of participants with clinical remission per adapted Mayo Score at Week 12","Clinical remission per adapted Mayo Score.","Week 12","Percentage of participants achieving clinical remission per full Mayo Score at Week 12 in subjects with a full Mayo score of 6 to 12 at Baseline|Ulcerative Colitis Symptom Questionnaire (UC-SQ): Change from Baseline to Week 12|Inflammatory Bowel Disease Questionnaire (IBDQ): Change from Baseline to Week 12|Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue): Change from Baseline to Week 12|Percentage of participants achieving clinical response per adapted Mayo Score at week 12|Percentage of participants with endoscopic remission at Week 12|Percentage of participants achieving clinical response per partial adapted Mayo Score at week 4|Percentage of participants with mucosal healing at Week 12|36-Item Short Form Health Status Survey (SF-36): Change from Baseline to Week 12|Percentage of participants with hospitalization through Week 12|Percentage of participants with Ulcerative Colitis (UC)-related surgeries through Week 12|Percentage of participants with endoscopic improvement at Week 12","Clinical remission per full Mayo Score.|The US-SQ is a patient questionnaire to assess severity of Crohn's symptoms.|The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.|The FACIT-Fatigue is a validated tool that measures an individual's level of fatigue during their usual daily activities over the past week.|Clinical response per adapted Mayo Score.|Endoscopic remission per endoscopy subscore.|Clinical response per partial adapted Mayo Score (without endoscopy).|Mucosal healing defined as endoscopic and histologic remission.|The SF-36 is an indicator of overall health status.|Participants with an event that results in admission to the hospital.|Participants who underwent surgery related to UC.|Endoscopic improvement per endoscopy subscore.","Week 12|Baseline, Week 12|Week 4|12 weeks","abbvieclinicaltrials@abbvie.com","ABBVIE CALL CENTER","847.283.8955",{"$cut":{"chars":21414,"head":"Buenos Aires, Argentina, 1431 Instituto Medico Cer /Id# 168686Quilmes, Argentina, 1878 Sanatorio 9 De Julio S.A. /Id# 167780San Miguel De Tucuman, Argentina, 4000|Rosario, Santa Fe, Argentina, 2000|Graz, Austria, 8036 Lkh Salzburg And Paracelsus /Id# 200685Salzburg, Austria, 5020|St. PÃ¶lten, Niederoesterreich, Austria, 3100|Vienna, Wien, Austria, 1090|Brussels, Bruxelles-Capitale, Belgium, 1070 Cliniques Universitaires Saint Luc /Id# 200039Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200|Liege, Liege, Belgium, 4000|Gent, Oost-Vlaanderen, Belgium, 9000|Jette, Brussels, Belgium, 1090 Uz Leuven /Id# 170812Leuven, Belgium, 3000 Clinique St Joseph /Id# 200250Liege, Belgium, 4000 Az-Delta /Id# 200040Roeselare, Belgium, 8800 Chu Dinant Godinne - Ucl Namur /Id# 200254Yvoir, Belgium, 5530|Goiania, Goias, Brazil, 74535-170|Curitiba, Parana, Brazil, 80810-040|Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903|Botucatu, Sao Paulo, Brazil, 18618-686 Hospital Das Clinicas Da Faculdade De Medicina De RibeirÃ£o Preto - Usp /Id# 157660RibeirÃ£o Preto, Sao Paulo, Brazil, 14048-900 Faculdade De Medicina Do Abc /Id# 163995Santo AndrÃ©, Sao Paulo, Brazil, 09060-870 Kaiser Clinica E Hospital Dia /Id# 157680Sao Jose Do Rio Preto, Sao Paulo, Brazil, 15015-110|Sliven, Bulgaria, 8800 Ii Mhat - Sofia /Id# 200799Sofia, Bulgaria, 1202 Umhat Tsaritsa Joanna - Isul /Id# 209977Sofia, Bulgaria, 1527 Umhat Sv. 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Klinikum Graz /Id# 169053|Niederoesterreich UniversitÃ¤tsklinikum St.PÃ¶lten /Id# 169048|Wien Medical University Of Vienna /Id# 169050|Bruxelles-Capitale Cub Hospital Erasme /Id# 200252|Liege Chu De Liege /Id# 200253|Oost-Vlaanderen Uz Gent /Id# 200251|Uz Brussels /Id# 164176|Goias Instituto Goiano De Gastroenterologia /Id# 157679|Parana Hospital Nossa Senhora Das GraÃ§as /Id# 157671|Rio Grande Do Sul Hospital De Clinicas De Porto Alegre /Id# 157662|Sao Paulo Upeclin Fmb - Unesp /Id# 157690|Mbal \"Hadzhi Dimitar\" /Id# 207945|Alberta University Of Calgary /Id# 169111|British Columbia Fraser Clinical Trials Inc /Id# 169102|New Brunswick Qeii Health Sciences Centre /Id# 169107|Nova Scotia Iwk Health Center /Id# 169110|Ontario London Health Sciences Centre /Id# 169103|Quebec Hopital Charles-Lemoyne /Id# 169105|Hospital Las Higueras /Id# 167093|Region Metropolitana De Santiago Complejo Asistencial Dr. Sotero Del Rio /Id# 169385|ValparaÃ­so Centro De Investigaciones ClÃ­nicas ViÃ±a Del Mar /Id# 203607|Cundinamarca Corporacion Hospitalaria Juan Ciudad Sede Denominada Hospital Universitario Mayo /Id# 158717|Instituto De Coloproctologia /Id# 158739|Grad Zagreb Klinicka Bolnica Dubrava Zagreb /Id# 157475|Klinicki Bolnicki Centar Split /Id# 157473|Osjecko-Baranjska Zupanija Klinicki Bolnicki Centar Osijek /Id# 157472|Hovedstaden Bispebjerg Hospital /Id# 208945|Hvidovre Hospital /Id# 202266|SjÃ¦lland Sjaellands Universitets Hospit /Id# 200033|Syddanmark Svendborg Sygehus, Sygehusenhe /Id# 200034|University Of Alexandria /Id# 200848|Alpes-Maritimes Chu De Nice-Hopital L'Archet Ii /Id# 171577|Chu Amiens Picardie - Site Sud /Id# 171576|Gironde HÃ´pital Haut-LÃ©vÃªque /Id# 171579|Hopital Beaujon /Id# 200092|Loire Chu De Saint Etienne - Hopital Nord /Id# 171580|Baden-Wuerttemberg Universitatsklinikum Mannheim /Id# 162035|Bayern Universitaetsklinikum Erlangen /Id# 159354|CharitÃ© UniversitÃ¤tsmedizin Campus Mitte /Id# 163688|Nordrhein-Westfalen Uniklinik Koln /Id# 164991|Schleswig-Holstein Univ Hosp Schleswig-Holstein /Id# 159360|Thueringen Universitaetsklinikum Ulm /Id# 164992|Attiki General Hospital Of Athens Laiko /Id# 206440|General Hospital Of Chest Diseases Of Athens \"Sotiria\" /Id# 170915|Baranya Mohacsi Korhaz /Id# 205347|Borsod-Abauj-Zemplen Miskolci Semmelweis Korhaz Es /Id# 201285|Heves Bugat Pal Korhaz /Id# 202528|Magyar Honvedseg Egeszsegugyi Kozpont /Id# 157329|Pest Obudai Egeszsegugyi Kozpont /Id# 201922|Hadarom Soroka Medical Center /Id# 171100|Rambam Medical Center /Id# 171101|Tel-Aviv Rabin Medical Center /Id# 167403|Yerushalayim Hadassah Ein Kerem Medical Ctr /Id# 171099|Calabria UniversitÃ  Di Catanzaro \"Magna Graecia\" /Id# 200125|Emilia-Romagna Ospedale Sant Orsola Malpighi /Id# 155611|Irccs Aou San Martino-Ist /Id# 164031|Lazio Policlinico Universitario Campus Bio-Medico /Id# 163992|Milano Istituto Clinico Humanitas /Id# 155610|Sicilia A.O. 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["5ecbf413307e3d1b1f8d9ccf","NCT03398148","2019-01-08","AbbVie","ABBV","Recruiting","A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy","Risankizumab","IL23 Inhibitor","Yes","['Risankizumab']","No",null,"Phase 2/Phase 3",16,720,"Anticipated","2018-03-07","2020-09-23",{"$nulls":5},"The objectives of Sub-Study 1 are to evaluate the efficacy, safety, and pharmacokinetics of risankizumab as induction treatment in subjects with moderately to severely active ulcerative colitis (UC), and to identify the appropriate induction dose of risankizumab for further evaluation in Sub-Study 2.\n\nThe objective of Sub-Study 2 is to evaluate the efficacy and safety of risankizumab compared to placebo in inducing clinical remission in subjects with moderately to severely active UC.",null,"A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy","M16-067","Ulcerative Colitis (UC)","Colitis|Colitis, Ulcerative","Gastrointestinal Diseases","Gastrointestinal","Experimental|Placebo Comparator","Substudy 1, Induction 2: Double-blind Risankizumab Dose 2|Substudy 2, Induction 1: Open-label Risankizumab Dose 2|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 2, Induction 2: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 2, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 3|Substudy 2, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 1, Induction 1: Open-label Risankizumab Dose 3","Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection in Induction 2.|Participants randomized to receive risankizumab dose 2 administered by intravenous (IV) infusion.|Participants who received placebo with inadequate response in Induction 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.|Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 3 administered by subcutaneous (SC) injection in Induction 2.|Participants randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion.|Participants who received placebo with inadequate response in Induction 1 receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.|Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.|Participants randomized to receive risankizumab dose 3 administered by intravenous (IV) infusion.|Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.|Participants receive risankizumab dose 3 administered by intravenous (IV) infusion.","Drug","risankizumab SC|risankizumab IV|placebo for risankizumab","risankizumab subcutaneous (SC) injection|risankizumab intravenous (IV) infusion|placebo for risankizumab","ABBV-066 | BI 655066","Substudy 1, Induction 2: Double-blind Risankizumab Dose 2|Substudy 2, Induction 1: Open-label Risankizumab Dose 2|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 2, Induction 2: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 2, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 3|Substudy 2, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 1, Induction 1: Open-label Risankizumab Dose 3","\n\n * Male or female aged >=18 to <= 80 years at the Baseline Visit. Where locally permissible, subjects 16 to < 18 years of age who meet the definition of Tanner stage 5 for development at the Baseline Visit\n * Confirmed diagnosis of ulcerative colitis (UC) for at least 3 months prior to Baseline.\n * Active UC as assessed by adapted Mayo Score\n * Demonstrated intolerance or inadequate response to one or more biologic therapies\n * Females must be postmenopausal for more than 2 years or surgically sterile or practicing specific forms of birth control.\n\n","\n\n * Subject with a current diagnosis of Crohn's disease (CD), inflammatory bowel disease-unclassified (IBD-U) or a history of radiation colitis or ischemic colitis.\n * Subject receiving prohibited medications and treatment.\n * Extent of inflammatory disease limited to the rectum as assessed by screening endoscopy.\n * Subject with currently known complications of UC (e.g., megacolon).",{"$nulls":4},"Actual","2018-01-12","Actual","Anticipated","2022-08-29","Anticipated","2019-01-01","2018-01-08","2018-01-08","2019-01-04","Yes","ABBV-066\nBI 655066","Interventional","Treatment","Parallel Assignment","Double (Participant, Investigator)","Randomized","16 Years","80 Years","All",null,"No","Yes\nAbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2016-004677-40","EudraCT Number","Percentage of participants with clinical remission per adapted Mayo Score at Week 12","Clinical remission per adapted Mayo Score.","Week 12","Percentage of participants achieving clinical remission per full Mayo Score at Week 12 in subjects with a full Mayo score of 6 to 12 at Baseline|Ulcerative Colitis Symptom Questionnaire (UC-SQ): Change from Baseline to Week 12|Inflammatory Bowel Disease Questionnaire (IBDQ): Change from Baseline to Week 12|Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue): Change from Baseline to Week 12|Percentage of participants achieving clinical response per adapted Mayo Score at week 12|Percentage of participants with endoscopic remission at Week 12|Percentage of participants achieving clinical response per partial adapted Mayo Score at week 4|Percentage of participants with mucosal healing at Week 12|36-Item Short Form Health Status Survey (SF-36): Change from Baseline to Week 12|Percentage of participants with hospitalization through Week 12|Percentage of participants with Ulcerative Colitis (UC)-related surgeries through Week 12|Percentage of participants with endoscopic improvement at Week 12","Clinical remission per full Mayo Score.|The US-SQ is a patient questionnaire to assess severity of Crohn's symptoms.|The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.|The FACIT-Fatigue is a validated tool that measures an individual's level of fatigue during their usual daily activities over the past week.|Clinical response per adapted Mayo Score.|Endoscopic remission per endoscopy subscore.|Clinical response per partial adapted Mayo Score (without endoscopy).|Mucosal healing defined as endoscopic and histologic remission.|The SF-36 is an indicator of overall health status.|Participants with an event that results in admission to the hospital.|Participants who underwent surgery related to UC.|Endoscopic improvement per endoscopy subscore.","Week 12|Baseline, Week 12|Week 4|12 weeks","abbvieclinicaltrials@abbvie.com","ABBVIE CALL CENTER","847.283.8955",{"$cut":{"chars":21327,"head":"Buenos Aires, Argentina, 1431 Instituto Medico Cer /Id# 168686Quilmes, Argentina, 1878 Sanatorio 9 De Julio S.A. /Id# 167780San Miguel De Tucuman, Argentina, 4000|Rosario, Santa Fe, Argentina, 2000|Graz, Austria, 8036 Lkh Salzburg And Paracelsus /Id# 200685Salzburg, Austria, 5020|St. PÃ¶lten, Niederoesterreich, Austria, 3100|Vienna, Wien, Austria, 1090|Brussels, Bruxelles-Capitale, Belgium, 1070 Cliniques Universitaires Saint Luc /Id# 200039Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200|Liege, Liege, Belgium, 4000|Gent, Oost-Vlaanderen, Belgium, 9000|Jette, Brussels, Belgium, 1090 Uz Leuven /Id# 170812Leuven, Belgium, 3000 Clinique St Joseph /Id# 200250Liege, Belgium, 4000 Az-Delta /Id# 200040Roeselare, Belgium, 8800 Chu Dinant Godinne - Ucl Namur /Id# 200254Yvoir, Belgium, 5530|Goiania, Goias, Brazil, 74535-170|Curitiba, Parana, Brazil, 80810-040|Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903|Botucatu, Sao Paulo, Brazil, 18618-686 Hospital Das Clinicas Da Faculdade De Medicina De RibeirÃ£o Preto - Usp /Id# 157660RibeirÃ£o Preto, Sao Paulo, Brazil, 14048-900 Faculdade De Medicina Do Abc /Id# 163995Santo AndrÃ©, Sao Paulo, Brazil, 09060-870 Kaiser Clinica E Hospital Dia /Id# 157680Sao Jose Do Rio Preto, Sao Paulo, Brazil, 15015-110|Sliven, Bulgaria, 8800 Ii Mhat - Sofia /Id# 200799Sofia, Bulgaria, 1202 Umhat Tsaritsa Joanna - Isul /Id# 209977Sofia, Bulgaria, 1527 Umhat Sv. 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Klinikum Graz /Id# 169053|Niederoesterreich UniversitÃ¤tsklinikum St.PÃ¶lten /Id# 169048|Wien Medical University Of Vienna /Id# 169050|Bruxelles-Capitale Cub Hospital Erasme /Id# 200252|Liege Chu De Liege /Id# 200253|Oost-Vlaanderen Uz Gent /Id# 200251|Uz Brussels /Id# 164176|Goias Instituto Goiano De Gastroenterologia /Id# 157679|Parana Hospital Nossa Senhora Das GraÃ§as /Id# 157671|Rio Grande Do Sul Hospital De Clinicas De Porto Alegre /Id# 157662|Sao Paulo Upeclin Fmb - Unesp /Id# 157690|Mbal \"Hadzhi Dimitar\" /Id# 207945|Alberta University Of Calgary /Id# 169111|British Columbia Fraser Clinical Trials Inc /Id# 169102|New Brunswick Qeii Health Sciences Centre /Id# 169107|Nova Scotia Iwk Health Center /Id# 169110|Ontario London Health Sciences Centre /Id# 169103|Quebec Hopital Charles-Lemoyne /Id# 169105|Hospital Las Higueras /Id# 167093|Region Metropolitana De Santiago Complejo Asistencial Dr. Sotero Del Rio /Id# 169385|ValparaÃ­so Centro De Investigaciones ClÃ­nicas ViÃ±a Del Mar /Id# 203607|Cundinamarca Corporacion Hospitalaria Juan Ciudad Sede Denominada Hospital Universitario Mayo /Id# 158717|Instituto De Coloproctologia /Id# 158739|Grad Zagreb Klinicka Bolnica Dubrava Zagreb /Id# 157475|Klinicki Bolnicki Centar Split /Id# 157473|Osjecko-Baranjska Zupanija Klinicki Bolnicki Centar Osijek /Id# 157472|Hovedstaden Bispebjerg Hospital /Id# 208945|Hvidovre Hospital /Id# 202266|SjÃ¦lland Sjaellands Universitets Hospit /Id# 200033|Syddanmark Svendborg Sygehus, Sygehusenhe /Id# 200034|University Of Alexandria /Id# 200848|Alpes-Maritimes Chu De Nice-Hopital L'Archet Ii /Id# 171577|Chu Amiens Picardie - Site Sud /Id# 171576|Gironde HÃ´pital Haut-LÃ©vÃªque /Id# 171579|Hopital Beaujon /Id# 200092|Loire Chu De Saint Etienne - Hopital Nord /Id# 171580|Baden-Wuerttemberg Universitatsklinikum Mannheim /Id# 162035|Bayern Universitaetsklinikum Erlangen /Id# 159354|Gastroenterologie Am Bayerisch /Id# 159361|Nordrhein-Westfalen Uniklinik Koln /Id# 164991|Schleswig-Holstein Univ Hosp Schleswig-Holstein /Id# 159360|Thueringen Universitaetsklinikum Ulm /Id# 164992|Attiki General Hospital Of Athens Laiko /Id# 206440|General Hospital Of Chest Diseases Of Athens \"Sotiria\" /Id# 170915|Baranya Mohacsi Korhaz /Id# 205347|Borsod-Abauj-Zemplen Miskolci Semmelweis Korhaz Es /Id# 201285|Heves Bugat Pal Korhaz /Id# 202528|Magyar Honvedseg Egeszsegugyi Kozpont /Id# 157329|Pest Obudai Egeszsegugyi Kozpont /Id# 201922|Hadarom Soroka Medical Center /Id# 171100|Rambam Medical Center /Id# 171101|Tel-Aviv Rabin Medical Center /Id# 167403|Yerushalayim Hadassah Ein Kerem Medical Ctr /Id# 171099|Calabria UniversitÃ  Di Catanzaro \"Magna Graecia\" /Id# 200125|Emilia-Romagna Ospedale Sant Orsola Malpighi /Id# 155611|Irccs Aou San Martino-Ist /Id# 164031|Lazio Policlinico Universitario Campus Bio-Medico /Id# 163992|Milano Istituto Clinico Humanitas /Id# 155610|Sicilia A.O. 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Rooseve /Id# 164347|Univ Medical Ctr Ljubljana /Id# 210627|, Free State Farmovs Integrated Research Solutions /Id# 207537|, Gauteng Wits Clinical Research Site /Id# 171136|, Western Cape Mediclinic Constantiaberg /Id# 171137|Dr Jp Wright /Id# 171138|Hospital Universitario Parc Tauli /Id# 159461|Pontevedra Hospital Alvaro Cunqueiro /Id# 167360|Su Molndal. /Id# 202843|Vastra Gotalands Lan AlingsÃ¥s Lasarett /Id# 202074|University Hospital Zurich /Id# 202910|Ankara Univ Medical Faculty /Id# 167210|Kayseri Erciyes University Medical Fac /Id# 171291|Kyivska Oblast Medical Centre Of Ok!Clinic Of International Institute Of Clinical Trials /Id# 205482|Regional Clinical Hospital /Id# 203367|, Devon Rd&E Hospital /Id# 157587|Barnsley Hospital Nhs Foundation Trust /Id# 202770|Ucsd /Id# 160452|Peak Gastroenterology Associat /Id# 165841|Medical Research Ctr Ct /Id# 160311|South Lake Pain Institute, Inc /Id# 162878|Emory University Hospital /Id# 160583|University Of Chicago /Id# 160521|Indiana University /Id# 167252|Cotton-O'Neil Clinical Res Ctr /Id# 160412|Delricht Research /Id# 206815|Mgh Digestive Health Center /Id# 164255|Center For Digestive Health /Id# 160327|Mayo Clinic - Rochester /Id# 200458|Quality Clinical Research Inc. /Id# 167313|Columbia Univ Medical Center /Id# 161934|Carolinas Medical Center /Id# 158512|Plains Clinical Research Center, Llc /Id# 169732|Cleveland Clinic Foundation /Id# 209232|Digestive Disease Specialists /Id# 170779|University Of Pennsylvania /Id# 166266|Gastroenterology Associates, P.A. /Id# 160472|Gastro One /Id# 160418|Inquest Clinical Research /Id# 165685|Hp Clinical Research /Id# 163007|Pediatric Specialty Of Va /Id# 166820|Virginia Mason Medical Center /Id# 160466",{"$nulls":3},"AbbVie Inc.","2019-01-04","2020-05-25T16:36:35.510","2020-05-26T17:10:42.972","NCT03398148"]
["5ecbf413feab101b1553086f","NCT03398148","2019-01-17","AbbVie","ABBV","Recruiting","A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy","Risankizumab","IL23 Inhibitor","Yes","['Risankizumab']","No",null,"Phase 2/Phase 3",16,720,"Anticipated","2018-03-07","2020-09-23",{"$nulls":5},"The objectives of Sub-Study 1 are to evaluate the efficacy, safety, and pharmacokinetics of risankizumab as induction treatment in subjects with moderately to severely active ulcerative colitis (UC), and to identify the appropriate induction dose of risankizumab for further evaluation in Sub-Study 2.\n\nThe objective of Sub-Study 2 is to evaluate the efficacy and safety of risankizumab compared to placebo in inducing clinical remission in subjects with moderately to severely active UC.",null,"A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy","M16-067","Ulcerative Colitis (UC)","Colitis|Colitis, Ulcerative","Gastrointestinal Diseases","Gastrointestinal","Experimental|Placebo Comparator","Substudy 1, Induction 2: Double-blind Risankizumab Dose 2|Substudy 2, Induction 1: Open-label Risankizumab Dose 2|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 2, Induction 2: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 2, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 3|Substudy 2, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 1, Induction 1: Open-label Risankizumab Dose 3","Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection in Induction 2.|Participants randomized to receive risankizumab dose 2 administered by intravenous (IV) infusion.|Participants who received placebo with inadequate response in Induction 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.|Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 3 administered by subcutaneous (SC) injection in Induction 2.|Participants randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion.|Participants who received placebo with inadequate response in Induction 1 receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.|Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.|Participants randomized to receive risankizumab dose 3 administered by intravenous (IV) infusion.|Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.|Participants receive risankizumab dose 3 administered by intravenous (IV) infusion.","Drug","risankizumab SC|risankizumab IV|placebo for risankizumab","risankizumab subcutaneous (SC) injection|risankizumab intravenous (IV) infusion|placebo for risankizumab","ABBV-066 | BI 655066","Substudy 1, Induction 2: Double-blind Risankizumab Dose 2|Substudy 2, Induction 1: Open-label Risankizumab Dose 2|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 2, Induction 2: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 2, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 3|Substudy 2, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 1, Induction 1: Open-label Risankizumab Dose 3","\n\n * Male or female aged >=18 to <= 80 years at the Baseline Visit. Where locally permissible, subjects 16 to < 18 years of age who meet the definition of Tanner stage 5 for development at the Baseline Visit\n * Confirmed diagnosis of ulcerative colitis (UC) for at least 3 months prior to Baseline.\n * Active UC as assessed by adapted Mayo Score\n * Demonstrated intolerance or inadequate response to one or more biologic therapies\n * Females must be postmenopausal for more than 2 years or surgically sterile or practicing specific forms of birth control.\n\n","\n\n * Subject with a current diagnosis of Crohn's disease (CD), inflammatory bowel disease-unclassified (IBD-U) or a history of radiation colitis or ischemic colitis.\n * Subject receiving prohibited medications and treatment.\n * Extent of inflammatory disease limited to the rectum as assessed by screening endoscopy.\n * Subject with currently known complications of UC (e.g., megacolon).",{"$nulls":4},"Actual","2018-01-12","Actual","Anticipated","2022-08-29","Anticipated","2019-01-01","2018-01-08","2018-01-08","2019-01-16","Yes","ABBV-066\nBI 655066","Interventional","Treatment","Parallel Assignment","Double (Participant, Investigator)","Randomized","16 Years","80 Years","All",null,"No","Yes\nAbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2016-004677-40","EudraCT Number","Percentage of participants with clinical remission per adapted Mayo Score at Week 12","Clinical remission per adapted Mayo Score.","Week 12","Percentage of participants achieving clinical remission per full Mayo Score at Week 12 in subjects with a full Mayo score of 6 to 12 at Baseline|Ulcerative Colitis Symptom Questionnaire (UC-SQ): Change from Baseline to Week 12|Inflammatory Bowel Disease Questionnaire (IBDQ): Change from Baseline to Week 12|Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue): Change from Baseline to Week 12|Percentage of participants achieving clinical response per adapted Mayo Score at week 12|Percentage of participants with endoscopic remission at Week 12|Percentage of participants achieving clinical response per partial adapted Mayo Score at week 4|Percentage of participants with mucosal healing at Week 12|36-Item Short Form Health Status Survey (SF-36): Change from Baseline to Week 12|Percentage of participants with hospitalization through Week 12|Percentage of participants with Ulcerative Colitis (UC)-related surgeries through Week 12|Percentage of participants with endoscopic improvement at Week 12","Clinical remission per full Mayo Score.|The US-SQ is a patient questionnaire to assess severity of Crohn's symptoms.|The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.|The FACIT-Fatigue is a validated tool that measures an individual's level of fatigue during their usual daily activities over the past week.|Clinical response per adapted Mayo Score.|Endoscopic remission per endoscopy subscore.|Clinical response per partial adapted Mayo Score (without endoscopy).|Mucosal healing defined as endoscopic and histologic remission.|The SF-36 is an indicator of overall health status.|Participants with an event that results in admission to the hospital.|Participants who underwent surgery related to UC.|Endoscopic improvement per endoscopy subscore.","Week 12|Baseline, Week 12|Week 4|12 weeks","abbvieclinicaltrials@abbvie.com","ABBVIE CALL CENTER","847.283.8955",{"$cut":{"chars":21236,"head":"Buenos Aires, Argentina, 1431 Instituto Medico Cer /Id# 168686Quilmes, Argentina, 1878 Sanatorio 9 De Julio S.A. /Id# 167780San Miguel De Tucuman, Argentina, 4000|Rosario, Santa Fe, Argentina, 2000|Graz, Austria, 8036 Lkh Salzburg And Paracelsus /Id# 200685Salzburg, Austria, 5020|St. PÃ¶lten, Niederoesterreich, Austria, 3100|Vienna, Wien, Austria, 1090|Brussels, Bruxelles-Capitale, Belgium, 1070 Cliniques Universitaires Saint Luc /Id# 200039Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200|Liege, Liege, Belgium, 4000|Gent, Oost-Vlaanderen, Belgium, 9000|Jette, Brussels, Belgium, 1090 Uz Leuven /Id# 170812Leuven, Belgium, 3000 Clinique St Joseph /Id# 200250Liege, Belgium, 4000 Az-Delta /Id# 200040Roeselare, Belgium, 8800 Chu Dinant Godinne - Ucl Namur /Id# 200254Yvoir, Belgium, 5530|Goiania, Goias, Brazil, 74535-170|Curitiba, Parana, Brazil, 80810-040|Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903|Botucatu, Sao Paulo, Brazil, 18618-686 Hospital Das Clinicas Da Faculdade De Medicina De RibeirÃ£o Preto - Usp /Id# 157660RibeirÃ£o Preto, Sao Paulo, Brazil, 14048-900 Faculdade De Medicina Do Abc /Id# 163995Santo AndrÃ©, Sao Paulo, Brazil, 09060-870 Kaiser Clinica E Hospital Dia /Id# 157680Sao Jose Do Rio Preto, Sao Paulo, Brazil, 15015-110|Sliven, Bulgaria, 8800 Ii Mhat - Sofia /Id# 200799Sofia, Bulgaria, 1202 Umhat Tsaritsa Joanna - Isul /Id# 209977Sofia, Bulgaria, 1527 Umhat Sv. 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Klinikum Graz /Id# 169053|Niederoesterreich UniversitÃ¤tsklinikum St.PÃ¶lten /Id# 169048|Wien Medical University Of Vienna /Id# 169050|Bruxelles-Capitale Cub Hospital Erasme /Id# 200252|Liege Chu De Liege /Id# 200253|Oost-Vlaanderen Uz Gent /Id# 200251|Uz Brussels /Id# 164176|Goias Instituto Goiano De Gastroenterologia /Id# 157679|Parana Hospital Nossa Senhora Das GraÃ§as /Id# 157671|Rio Grande Do Sul Hospital De Clinicas De Porto Alegre /Id# 157662|Sao Paulo Upeclin Fmb - Unesp /Id# 157690|Mbal \"Hadzhi Dimitar\" /Id# 207945|Alberta University Of Calgary /Id# 169111|British Columbia Fraser Clinical Trials Inc /Id# 169102|New Brunswick Qeii Health Sciences Centre /Id# 169107|Nova Scotia Iwk Health Center /Id# 169110|Ontario London Health Sciences Centre /Id# 169103|Quebec Hopital Charles-Lemoyne /Id# 169105|Hospital Las Higueras /Id# 167093|Region Metropolitana De Santiago Complejo Asistencial Dr. Sotero Del Rio /Id# 169385|ValparaÃ­so Centro De Investigaciones ClÃ­nicas ViÃ±a Del Mar /Id# 203607|Cundinamarca Corporacion Hospitalaria Juan Ciudad Sede Denominada Hospital Universitario Mayo /Id# 158717|Instituto De Coloproctologia /Id# 158739|Grad Zagreb Klinicka Bolnica Dubrava Zagreb /Id# 157475|Klinicki Bolnicki Centar Split /Id# 157473|Osjecko-Baranjska Zupanija Klinicki Bolnicki Centar Osijek /Id# 157472|Hovedstaden Bispebjerg Hospital /Id# 208945|Hvidovre Hospital /Id# 202266|SjÃ¦lland Sjaellands Universitets Hospit /Id# 200033|Syddanmark Odense Universitets Hospital /Id# 205602|University Of Alexandria /Id# 200848|Alpes-Maritimes Chu De Nice-Hopital L'Archet Ii /Id# 171577|Chu Amiens Picardie - Site Sud /Id# 171576|Gironde HÃ´pital Haut-LÃ©vÃªque /Id# 171579|Hopital Beaujon /Id# 200092|Loire Chu De Saint Etienne - Hopital Nord /Id# 171580|Baden-Wuerttemberg Universitatsklinikum Mannheim /Id# 162035|Bayern Universitaetsklinikum Erlangen /Id# 159354|Gastroenterologie Am Bayerisch /Id# 159361|Nordrhein-Westfalen Uniklinik Koln /Id# 164991|Schleswig-Holstein Univ Hosp Schleswig-Holstein /Id# 159360|Thueringen Universitaetsklinikum Ulm /Id# 164992|Attiki General Hospital Of Athens Laiko /Id# 206440|General Hospital Of Chest Diseases Of Athens \"Sotiria\" /Id# 170915|Baranya Mohacsi Korhaz /Id# 205347|Borsod-Abauj-Zemplen Miskolci Semmelweis Korhaz Es /Id# 201285|Heves Bugat Pal Korhaz /Id# 202528|Magyar Honvedseg Egeszsegugyi Kozpont /Id# 157329|Pest Obudai Egeszsegugyi Kozpont /Id# 201922|Hadarom Soroka Medical Center /Id# 171100|Rambam Medical Center /Id# 171101|Tel-Aviv Rabin Medical Center /Id# 167403|Yerushalayim Hadassah Ein Kerem Medical Ctr /Id# 171099|Calabria UniversitÃ  Di Catanzaro \"Magna Graecia\" /Id# 200125|Emilia-Romagna Ospedale Sant Orsola Malpighi /Id# 155611|Irccs Aou San Martino-Ist /Id# 164031|Lazio Policlinico Universitario Campus Bio-Medico /Id# 163992|Milano Istituto Clinico Humanitas /Id# 155610|Sicilia A.O. Per L'Emergenza Cannizzaro /Id# 164036|Verona Ospedale Classificato Equiparato Sacro Cuore-Don Calabria /Id# 164041|Aichi Aichi Medical University Hosp /Id# 164332|Chiba Toho University Sakura Medical Center /Id# 164254|Fukuoka Fukuoka University Chikushi Hospital /Id# 209055|Gifu Gifu University Hospital /Id# 208081|Gunma National Hospital Organization Takasaki General Medical Center /Id# 164437|Hiroshima Nho Fukuyama Medical Center /Id# 164439|Hiroshima University Hospital /Id# 164426|Hokkaido Asahikawa Medical University Hospital /Id# 164433|Hyogo Aoyama Clinic /Id# 164425|Ishikawa Kanazawa University Ho /Id# 169224|Kanagawa Gokeikai Ofuna Chuo Hospital /Id# 169300|Mie Mie University Hospital /Id# 203633|Miyagi Tohoku University Hospital /Id# 164430|Nagasaki Nagasaki University Hospital /Id# 202674|Saitama Tokito Clinic /Id# 164253|Shiga Shiga Univ Med Science Hosp /Id# 164440|Tokyo Medical Hospital Of Tokyo Medical And Dental University /Id# 164258|Yamagata Yamagata University Hospital /Id# 171474|Riga East Clinical Univ Hosp /Id# 163802|Kaunas Hospital Of Lithuanian Univers /Id# 170714|Klaipeda Seamens Hospital /Id# 170847|Selangor Ukm Medical Centre /Id# 200635|Jalisco InvestigaciÃ³n BiomÃ©dica Para El Desarrollo De FÃ¡rmacos, S.A. 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Rooseve /Id# 164347|Univ Medical Ctr Ljubljana /Id# 210627|, Free State Farmovs Integrated Research Solutions /Id# 207537|, Gauteng Wits Clinical Research Site /Id# 171136|, Western Cape Mediclinic Constantiaberg /Id# 171137|Dr Jp Wright /Id# 171138|Hospital Universitario Parc Tauli /Id# 159461|Pontevedra Hospital Alvaro Cunqueiro /Id# 167360|Su Molndal. /Id# 202843|Vastra Gotalands Lan AlingsÃ¥s Lasarett /Id# 202074|University Hospital Zurich /Id# 202910|Ankara Univ Medical Faculty /Id# 167210|Kayseri Erciyes University Medical Fac /Id# 171291|Kyivska Oblast Medical Centre Of Ok!Clinic Of International Institute Of Clinical Trials /Id# 205482|Regional Clinical Hospital /Id# 203367|, Devon Rd&E Hospital /Id# 157587|Barnsley Hospital Nhs Foundation Trust /Id# 202770|Ucsd /Id# 160452|Peak Gastroenterology Associat /Id# 165841|Medical Research Ctr Ct /Id# 160311|South Lake Pain Institute, Inc /Id# 162878|Emory University Hospital /Id# 160583|University Of Chicago /Id# 160521|Indiana University /Id# 167252|Cotton-O'Neil Clinical Res Ctr /Id# 160412|Delricht Research /Id# 206815|Mgh Digestive Health Center /Id# 164255|Center For Digestive Health /Id# 160327|Mayo Clinic - Rochester /Id# 200458|Quality Clinical Research Inc. /Id# 167313|Columbia Univ Medical Center /Id# 161934|Carolinas Medical Center /Id# 158512|Plains Clinical Research Center, Llc /Id# 169732|Cleveland Clinic Foundation /Id# 209232|Digestive Disease Specialists /Id# 170779|University Of Pennsylvania /Id# 166266|Gastroenterology Associates, P.A. /Id# 160472|Gastro One /Id# 160418|Inquest Clinical Research /Id# 165685|Hp Clinical Research /Id# 163007|Pediatric Specialty Of Va /Id# 166820|Virginia Mason Medical Center /Id# 160466",{"$nulls":3},"AbbVie Inc.","2019-01-16","2020-05-25T16:36:35.570","2020-05-26T17:10:42.972","NCT03398148"]
["5ecbf41411702c1b1b916a50","NCT03398148","2019-02-07","AbbVie","ABBV","Recruiting","A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy","Risankizumab","IL23 Inhibitor","Yes","['Risankizumab']","No",null,"Phase 2/Phase 3",16,720,"Anticipated","2018-03-07","2020-09-23",{"$nulls":5},"The objectives of Sub-Study 1 are to evaluate the efficacy, safety, and pharmacokinetics of risankizumab as induction treatment in subjects with moderately to severely active ulcerative colitis (UC), and to identify the appropriate induction dose of risankizumab for further evaluation in Sub-Study 2.\n\nThe objective of Sub-Study 2 is to evaluate the efficacy and safety of risankizumab compared to placebo in inducing clinical remission in subjects with moderately to severely active UC.",null,"A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy","M16-067","Ulcerative Colitis (UC)","Colitis|Colitis, Ulcerative","Gastrointestinal Diseases","Gastrointestinal","Experimental|Placebo Comparator","Substudy 1, Induction 2: Double-blind Risankizumab Dose 2|Substudy 2, Induction 1: Open-label Risankizumab Dose 2|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 2, Induction 2: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 2, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 3|Substudy 2, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 1, Induction 1: Open-label Risankizumab Dose 3","Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection in Induction 2.|Participants randomized to receive risankizumab dose 2 administered by intravenous (IV) infusion.|Participants who received placebo with inadequate response in Induction 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.|Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 3 administered by subcutaneous (SC) injection in Induction 2.|Participants randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion.|Participants who received placebo with inadequate response in Induction 1 receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.|Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.|Participants randomized to receive risankizumab dose 3 administered by intravenous (IV) infusion.|Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.|Participants receive risankizumab dose 3 administered by intravenous (IV) infusion.","Drug","risankizumab SC|risankizumab IV|placebo for risankizumab","risankizumab subcutaneous (SC) injection|risankizumab intravenous (IV) infusion|placebo for risankizumab","ABBV-066 | BI 655066","Substudy 1, Induction 2: Double-blind Risankizumab Dose 2|Substudy 2, Induction 1: Open-label Risankizumab Dose 2|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 2, Induction 2: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 2, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 3|Substudy 2, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 1, Induction 1: Open-label Risankizumab Dose 3","\n\n * Male or female aged >=18 to <= 80 years at the Baseline Visit. Where locally permissible, subjects 16 to < 18 years of age who meet the definition of Tanner stage 5 for development at the Baseline Visit\n * Confirmed diagnosis of ulcerative colitis (UC) for at least 3 months prior to Baseline.\n * Active UC as assessed by adapted Mayo Score\n * Demonstrated intolerance or inadequate response to one or more biologic therapies\n * Females must be postmenopausal for more than 2 years or surgically sterile or practicing specific forms of birth control.\n\n","\n\n * Subject with a current diagnosis of Crohn's disease (CD), inflammatory bowel disease-unclassified (IBD-U) or a history of radiation colitis or ischemic colitis.\n * Subject receiving prohibited medications and treatment.\n * Extent of inflammatory disease limited to the rectum as assessed by screening endoscopy.\n * Subject with currently known complications of UC (e.g., megacolon).",{"$nulls":4},"Actual","2018-01-12","Actual","Anticipated","2022-08-29","Anticipated","2019-02-01","2018-01-08","2018-01-08","2019-02-05","Yes","ABBV-066\nBI 655066","Interventional","Treatment","Parallel Assignment","Double (Participant, Investigator)","Randomized","16 Years","80 Years","All",null,"No","Yes\nAbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2016-004677-40","EudraCT Number","Percentage of participants with clinical remission per adapted Mayo Score at Week 12","Clinical remission per adapted Mayo Score.","Week 12","Percentage of participants achieving clinical remission per full Mayo Score at Week 12 in subjects with a full Mayo score of 6 to 12 at Baseline|Ulcerative Colitis Symptom Questionnaire (UC-SQ): Change from Baseline to Week 12|Inflammatory Bowel Disease Questionnaire (IBDQ): Change from Baseline to Week 12|Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue): Change from Baseline to Week 12|Percentage of participants achieving clinical response per adapted Mayo Score at week 12|Percentage of participants with endoscopic remission at Week 12|Percentage of participants achieving clinical response per partial adapted Mayo Score at week 4|Percentage of participants with mucosal healing at Week 12|36-Item Short Form Health Status Survey (SF-36): Change from Baseline to Week 12|Percentage of participants with hospitalization through Week 12|Percentage of participants with Ulcerative Colitis (UC)-related surgeries through Week 12|Percentage of participants with endoscopic improvement at Week 12","Clinical remission per full Mayo Score.|The US-SQ is a patient questionnaire to assess severity of Crohn's symptoms.|The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.|The FACIT-Fatigue is a validated tool that measures an individual's level of fatigue during their usual daily activities over the past week.|Clinical response per adapted Mayo Score.|Endoscopic remission per endoscopy subscore.|Clinical response per partial adapted Mayo Score (without endoscopy).|Mucosal healing defined as endoscopic and histologic remission.|The SF-36 is an indicator of overall health status.|Participants with an event that results in admission to the hospital.|Participants who underwent surgery related to UC.|Endoscopic improvement per endoscopy subscore.","Week 12|Baseline, Week 12|Week 4|12 weeks","abbvieclinicaltrials@abbvie.com","ABBVIE CALL CENTER","847.283.8955",{"$cut":{"chars":21115,"head":"Buenos Aires, Argentina, 1431 Instituto Medico Cer /Id# 168686Quilmes, Argentina, 1878 Sanatorio 9 De Julio S.A. /Id# 167780San Miguel De Tucuman, Argentina, 4000|Rosario, Santa Fe, Argentina, 2000|Graz, Austria, 8036 Lkh Salzburg And Paracelsus /Id# 200685Salzburg, Austria, 5020|St. PÃ¶lten, Niederoesterreich, Austria, 3100|Vienna, Wien, Austria, 1090|Brussels, Bruxelles-Capitale, Belgium, 1070 Cliniques Universitaires Saint Luc /Id# 200039Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200|Liege, Liege, Belgium, 4000|Gent, Oost-Vlaanderen, Belgium, 9000|Jette, Brussels, Belgium, 1090 Uz Leuven /Id# 170812Leuven, Belgium, 3000 Clinique St Joseph /Id# 200250Liege, Belgium, 4000 Az-Delta /Id# 200040Roeselare, Belgium, 8800 Chu Dinant Godinne - Ucl Namur /Id# 200254Yvoir, Belgium, 5530|Goiania, Goias, Brazil, 74535-170|Curitiba, Parana, Brazil, 80810-040|Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903|Botucatu, Sao Paulo, Brazil, 18618-686 Hospital Das Clinicas Da Faculdade De Medicina De RibeirÃ£o Preto - Usp /Id# 157660RibeirÃ£o Preto, Sao Paulo, Brazil, 14048-900 Faculdade De Medicina Do Abc /Id# 163995Santo AndrÃ©, Sao Paulo, Brazil, 09060-870 Kaiser Clinica E Hospital Dia /Id# 157680Sao Jose Do Rio Preto, Sao Paulo, Brazil, 15015-110|Sliven, Bulgaria, 8800 Ii Mhat - Sofia /Id# 200799Sofia, Bulgaria, 1202 Umhat Tsaritsa Joanna - Isul /Id# 209977Sofia, Bulgaria, 1527 Umhat Sv. 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Klinikum Graz /Id# 169053|Niederoesterreich UniversitÃ¤tsklinikum St.PÃ¶lten /Id# 169048|Wien Medical University Of Vienna /Id# 169050|Bruxelles-Capitale Cub Hospital Erasme /Id# 200252|Liege Chu De Liege /Id# 200253|Oost-Vlaanderen Uz Gent /Id# 200251|Uz Brussels /Id# 164176|Goias Instituto Goiano De Gastroenterologia /Id# 157679|Parana Hospital Nossa Senhora Das GraÃ§as /Id# 157671|Rio Grande Do Sul Hospital De Clinicas De Porto Alegre /Id# 157662|Sao Paulo Upeclin Fmb - Unesp /Id# 157690|Mbal \"Hadzhi Dimitar\" /Id# 207945|Alberta University Of Calgary /Id# 169111|British Columbia Fraser Clinical Trials Inc /Id# 169102|New Brunswick Qeii Health Sciences Centre /Id# 169107|Nova Scotia Iwk Health Center /Id# 169110|Ontario London Health Sciences Centre /Id# 169103|Quebec Hopital Charles-Lemoyne /Id# 169105|Hospital Las Higueras /Id# 167093|Region Metropolitana De Santiago Complejo Asistencial Dr. Sotero Del Rio /Id# 169385|ValparaÃ­so Centro De Investigaciones ClÃ­nicas ViÃ±a Del Mar /Id# 203607|Cundinamarca Corporacion Hospitalaria Juan Ciudad Sede Denominada Hospital Universitario Mayo /Id# 158717|Instituto De Coloproctologia /Id# 158739|Grad Zagreb Klinicka Bolnica Dubrava Zagreb /Id# 157475|Klinicki Bolnicki Centar Split /Id# 157473|Osjecko-Baranjska Zupanija Klinicki Bolnicki Centar Osijek /Id# 157472|Hovedstaden Bispebjerg Hospital /Id# 208945|Hvidovre Hospital /Id# 202266|SjÃ¦lland Sjaellands Universitets Hospit /Id# 200033|Syddanmark Odense Universitets Hospital /Id# 205602|University Of Alexandria /Id# 200848|Alpes-Maritimes Chu De Nice-Hopital L'Archet Ii /Id# 171577|Chu Amiens Picardie - Site Sud /Id# 171576|Gironde HÃ´pital Haut-LÃ©vÃªque /Id# 171579|Hopital Beaujon /Id# 200092|Loire Chu De Saint Etienne - Hopital Nord /Id# 171580|Baden-Wuerttemberg Universitatsklinikum Mannheim /Id# 162035|Bayern Universitaetsklinikum Erlangen /Id# 159354|Gastroenterologie Am Bayerisch /Id# 159361|Nordrhein-Westfalen Uniklinik Koln /Id# 164991|Schleswig-Holstein Univ Hosp Schleswig-Holstein /Id# 159360|Thueringen Universitaetsklinikum Ulm /Id# 164992|Attiki General Hospital Of Athens Laiko /Id# 206440|General Hospital Of Chest Diseases Of Athens \"Sotiria\" /Id# 170915|Baranya Mohacsi Korhaz /Id# 205347|Borsod-Abauj-Zemplen Miskolci Semmelweis Korhaz Es /Id# 201285|Heves Bugat Pal Korhaz /Id# 202528|Magyar Honvedseg Egeszsegugyi Kozpont /Id# 157329|Pest Obudai Egeszsegugyi Kozpont /Id# 201922|Hadarom Soroka Medical Center /Id# 171100|Rambam Medical Center /Id# 171101|Tel-Aviv Rabin Medical Center /Id# 167403|Yerushalayim Hadassah Ein Kerem Medical Ctr /Id# 171099|Calabria UniversitÃ  Di Catanzaro \"Magna Graecia\" /Id# 200125|Emilia-Romagna Ospedale Sant Orsola Malpighi /Id# 155611|Irccs Aou San Martino-Ist /Id# 164031|Lazio Policlinico Universitario Campus Bio-Medico /Id# 163992|Milano Istituto Clinico Humanitas /Id# 155610|Sicilia A.O. 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Rooseve /Id# 164347|Univ Medical Ctr Ljubljana /Id# 210627|, Free State Farmovs Integrated Research Solutions /Id# 207537|, Gauteng Wits Clinical Research Site /Id# 171136|, Western Cape Mediclinic Constantiaberg /Id# 171137|Dr Jp Wright /Id# 171138|Hospital Universitario Parc Tauli /Id# 159461|Pontevedra Hospital Alvaro Cunqueiro /Id# 167360|Su Molndal. /Id# 202843|Vastra Gotalands Lan AlingsÃ¥s Lasarett /Id# 202074|University Hospital Zurich /Id# 202910|Ankara Univ Medical Faculty /Id# 167210|Kayseri Erciyes University Medical Fac /Id# 171291|Kyivska Oblast Medical Centre Of Ok!Clinic Of International Institute Of Clinical Trials /Id# 205482|Regional Clinical Hospital /Id# 203367|, Devon Rd&E Hospital /Id# 157587|Barnsley Hospital Nhs Foundation Trust /Id# 202770|Ucsd /Id# 160452|Peak Gastroenterology Associat /Id# 165841|Medical Research Ctr Ct /Id# 160311|South Lake Pain Institute, Inc /Id# 162878|Emory University Hospital /Id# 160583|University Of Chicago /Id# 160521|Indiana University /Id# 167252|Cotton-O'Neil Clinical Res Ctr /Id# 160412|Delricht Research /Id# 206815|Mgh Digestive Health Center /Id# 164255|Center For Digestive Health /Id# 160327|Mayo Clinic - Rochester /Id# 200458|Quality Clinical Research Inc. /Id# 167313|Columbia Univ Medical Center /Id# 161934|Carolinas Medical Center /Id# 158512|Plains Clinical Research Center, Llc /Id# 169732|Cleveland Clinic Foundation /Id# 209232|Digestive Disease Specialists /Id# 170779|University Of Pennsylvania /Id# 166266|Gastroenterology Associates, P.A. /Id# 160472|Gastro One /Id# 160418|Inquest Clinical Research /Id# 165685|Advanced Research Institute /Id# 160480|Virginia Mason Medical Center /Id# 160466",{"$nulls":3},"AbbVie Inc.","2019-02-05","2020-05-25T16:36:36.095","2020-05-26T17:10:42.972","NCT03398148"]
["5ecbf414feab101b15530870","NCT03398148","2019-03-01","AbbVie","ABBV","Recruiting","A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy","Risankizumab","IL23 Inhibitor","Yes","['Risankizumab']","No",null,"Phase 2/Phase 3",16,720,"Anticipated","2018-03-07","2020-09-23",{"$nulls":5},"The objectives of Sub-Study 1 are to evaluate the efficacy, safety, and pharmacokinetics of risankizumab as induction treatment in subjects with moderately to severely active ulcerative colitis (UC), and to identify the appropriate induction dose of risankizumab for further evaluation in Sub-Study 2.\n\nThe objective of Sub-Study 2 is to evaluate the efficacy and safety of risankizumab compared to placebo in inducing clinical remission in subjects with moderately to severely active UC.",null,"A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy","M16-067","Ulcerative Colitis (UC)","Colitis|Colitis, Ulcerative","Gastrointestinal Diseases","Gastrointestinal","Experimental|Placebo Comparator","Substudy 1, Induction 2: Double-blind Risankizumab Dose 2|Substudy 2, Induction 1: Open-label Risankizumab Dose 2|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 2, Induction 2: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 2, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 3|Substudy 2, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 1, Induction 1: Open-label Risankizumab Dose 3","Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection in Induction 2.|Participants randomized to receive risankizumab dose 2 administered by intravenous (IV) infusion.|Participants who received placebo with inadequate response in Induction 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.|Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 3 administered by subcutaneous (SC) injection in Induction 2.|Participants randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion.|Participants who received placebo with inadequate response in Induction 1 receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.|Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.|Participants randomized to receive risankizumab dose 3 administered by intravenous (IV) infusion.|Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.|Participants receive risankizumab dose 3 administered by intravenous (IV) infusion.","Drug","risankizumab SC|risankizumab IV|placebo for risankizumab","risankizumab subcutaneous (SC) injection|risankizumab intravenous (IV) infusion|placebo for risankizumab","ABBV-066 | BI 655066","Substudy 1, Induction 2: Double-blind Risankizumab Dose 2|Substudy 2, Induction 1: Open-label Risankizumab Dose 2|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 2, Induction 2: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 2, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 3|Substudy 2, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 1, Induction 1: Open-label Risankizumab Dose 3","\n\n * Male or female aged >=18 to <= 80 years at the Baseline Visit. Where locally permissible, subjects 16 to < 18 years of age who meet the definition of Tanner stage 5 for development at the Baseline Visit\n * Confirmed diagnosis of ulcerative colitis (UC) for at least 3 months prior to Baseline.\n * Active UC as assessed by adapted Mayo Score\n * Demonstrated intolerance or inadequate response to one or more biologic therapies\n * Females must be postmenopausal for more than 2 years or surgically sterile or practicing specific forms of birth control.\n\n","\n\n * Subject with a current diagnosis of Crohn's disease (CD), inflammatory bowel disease-unclassified (IBD-U) or a history of radiation colitis or ischemic colitis.\n * Subject receiving prohibited medications and treatment.\n * Extent of inflammatory disease limited to the rectum as assessed by screening endoscopy.\n * Subject with currently known complications of UC (e.g., megacolon).",{"$nulls":4},"Actual","2018-01-12","Actual","Anticipated","2022-08-29","Anticipated","2019-02-01","2018-01-08","2018-01-08","2019-02-27","Yes","ABBV-066\nBI 655066","Interventional","Treatment","Parallel Assignment","Double (Participant, Investigator)","Randomized","16 Years","80 Years","All",null,"No","Yes\nAbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2016-004677-40","EudraCT Number","Percentage of participants with clinical remission per adapted Mayo Score at Week 12","Clinical remission per adapted Mayo Score.","Week 12","Percentage of participants achieving clinical remission per full Mayo Score at Week 12 in subjects with a full Mayo score of 6 to 12 at Baseline|Ulcerative Colitis Symptom Questionnaire (UC-SQ): Change from Baseline to Week 12|Inflammatory Bowel Disease Questionnaire (IBDQ): Change from Baseline to Week 12|Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue): Change from Baseline to Week 12|Percentage of participants achieving clinical response per adapted Mayo Score at week 12|Percentage of participants with endoscopic remission at Week 12|Percentage of participants achieving clinical response per partial adapted Mayo Score at week 4|Percentage of participants with mucosal healing at Week 12|36-Item Short Form Health Status Survey (SF-36): Change from Baseline to Week 12|Percentage of participants with hospitalization through Week 12|Percentage of participants with Ulcerative Colitis (UC)-related surgeries through Week 12|Percentage of participants with endoscopic improvement at Week 12","Clinical remission per full Mayo Score.|The US-SQ is a patient questionnaire to assess severity of Crohn's symptoms.|The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.|The FACIT-Fatigue is a validated tool that measures an individual's level of fatigue during their usual daily activities over the past week.|Clinical response per adapted Mayo Score.|Endoscopic remission per endoscopy subscore.|Clinical response per partial adapted Mayo Score (without endoscopy).|Mucosal healing defined as endoscopic and histologic remission.|The SF-36 is an indicator of overall health status.|Participants with an event that results in admission to the hospital.|Participants who underwent surgery related to UC.|Endoscopic improvement per endoscopy subscore.","Week 12|Baseline, Week 12|Week 4|12 weeks","abbvieclinicaltrials@abbvie.com","ABBVIE CALL CENTER","847.283.8955",{"$cut":{"chars":21347,"head":"Buenos Aires, Argentina, 1431 Instituto Medico Cer /Id# 168686Quilmes, Argentina, 1878 Sanatorio 9 De Julio S.A. /Id# 167780San Miguel De Tucuman, Argentina, 4000|Rosario, Santa Fe, Argentina, 2000|Graz, Austria, 8036 Lkh Salzburg And Paracelsus /Id# 200685Salzburg, Austria, 5020|St. PÃ¶lten, Niederoesterreich, Austria, 3100|Vienna, Wien, Austria, 1090|Brussels, Bruxelles-Capitale, Belgium, 1070 Cliniques Universitaires Saint Luc /Id# 200039Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200|Liege, Liege, Belgium, 4000|Gent, Oost-Vlaanderen, Belgium, 9000|Jette, Brussels, Belgium, 1090 Uz Leuven /Id# 170812Leuven, Belgium, 3000 Clinique St Joseph /Id# 200250Liege, Belgium, 4000 Az-Delta /Id# 200040Roeselare, Belgium, 8800 Chu Dinant Godinne - Ucl Namur /Id# 200254Yvoir, Belgium, 5530|Goiania, Goias, Brazil, 74535-170|Curitiba, Parana, Brazil, 80810-040|Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903|Botucatu, Sao Paulo, Brazil, 18618-686 Hospital Das Clinicas Da Faculdade De Medicina De RibeirÃ£o Preto - Usp /Id# 157660RibeirÃ£o Preto, Sao Paulo, Brazil, 14048-900 Faculdade De Medicina Do Abc /Id# 163995Santo AndrÃ©, Sao Paulo, Brazil, 09060-870 Kaiser Clinica E Hospital Dia /Id# 157680Sao Jose Do Rio Preto, Sao Paulo, Brazil, 15015-110|Sliven, Bulgaria, 8800 Ii Mhat - Sofia /Id# 200799Sofia, Bulgaria, 1202 Umhat Tsaritsa Joanna - Isul /Id# 209977Sofia, Bulgaria, 1527 Umhat Sv. 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Klinikum Graz /Id# 169053|Niederoesterreich UniversitÃ¤tsklinikum St.PÃ¶lten /Id# 169048|Wien Medical University Of Vienna /Id# 169050|Bruxelles-Capitale Cub Hospital Erasme /Id# 200252|Liege Chu De Liege /Id# 200253|Oost-Vlaanderen Uz Gent /Id# 200251|Uz Brussels /Id# 164176|Goias Instituto Goiano De Gastroenterologia /Id# 157679|Parana Hospital Nossa Senhora Das GraÃ§as /Id# 157671|Rio Grande Do Sul Hospital De Clinicas De Porto Alegre /Id# 157662|Sao Paulo Upeclin Fmb - Unesp /Id# 157690|Mbal \"Hadzhi Dimitar\" /Id# 207945|Alberta University Of Calgary /Id# 169111|British Columbia Fraser Clinical Trials Inc /Id# 169102|Nova Scotia Qeii Health Sciences Centre /Id# 169107|Ontario London Health Sciences Centre /Id# 169103|Quebec Hopital Charles-Lemoyne /Id# 169105|Hospital ClÃ­nico Regional Dr. Guillermo Grant Benavente /Id# 210761|Region Metropolitana De Santiago Complejo Asistencial Dr. Sotero Del Rio /Id# 169385|ValparaÃ­so Centro De Investigaciones ClÃ­nicas ViÃ±a Del Mar /Id# 203607|Cundinamarca Corporacion Hospitalaria Juan Ciudad Sede Denominada Hospital Universitario Mayo /Id# 158717|Instituto De Coloproctologia /Id# 158739|Grad Zagreb Klinicka Bolnica Dubrava Zagreb /Id# 157475|Klinicki Bolnicki Centar Split /Id# 157473|Osjecko-Baranjska Zupanija Klinicki Bolnicki Centar Osijek /Id# 157472|Hovedstaden Bispebjerg Hospital /Id# 208945|Hvidovre Hospital /Id# 202266|SjÃ¦lland Sjaellands Universitets Hospit /Id# 200033|Syddanmark Odense Universitets Hospital /Id# 205602|University Of Alexandria /Id# 200848|Alpes-Maritimes Chu De Nice-Hopital L'Archet Ii /Id# 171577|Chu Amiens Picardie - Site Sud /Id# 171576|Gironde HÃ´pital Haut-LÃ©vÃªque /Id# 171579|Hopital Beaujon /Id# 200092|Loire Chu De Saint Etienne - Hopital Nord /Id# 171580|Baden-Wuerttemberg Universitatsklinikum Mannheim /Id# 162035|Bayern Universitaetsklinikum Erlangen /Id# 159354|Gastroenterologie Am Bayerisch /Id# 159361|Nordrhein-Westfalen Uniklinik Koln /Id# 164991|Schleswig-Holstein Univ Hosp Schleswig-Holstein /Id# 159360|Thueringen Universitaetsklinikum Ulm /Id# 164992|Attiki General Hospital Of Athens Laiko /Id# 206440|General Hospital Of Chest Diseases Of Athens \"Sotiria\" /Id# 170915|Baranya Mohacsi Korhaz /Id# 205347|Borsod-Abauj-Zemplen Miskolci Semmelweis Korhaz Es /Id# 201285|Heves Bugat Pal Korhaz /Id# 202528|Magyar Honvedseg Egeszsegugyi Kozpont /Id# 157329|Pest Obudai Egeszsegugyi Kozpont /Id# 201922|Hadarom Soroka Medical Center /Id# 171100|Rambam Medical Center /Id# 171101|Tel-Aviv Rabin Medical Center /Id# 167403|Yerushalayim Hadassah Ein Kerem Medical Ctr /Id# 171099|Calabria UniversitÃ  Di Catanzaro \"Magna Graecia\" /Id# 200125|Emilia-Romagna Ospedale Sant Orsola Malpighi /Id# 155611|Irccs Aou San Martino-Ist /Id# 164031|Lazio Policlinico Universitario Campus Bio-Medico /Id# 163992|Milano Istituto Clinico Humanitas /Id# 155610|Sicilia A.O. 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Rooseve /Id# 164347|Univ Medical Ctr Ljubljana /Id# 210627|, Free State Farmovs Integrated Research Solutions /Id# 207537|, Gauteng Wits Clinical Research Site /Id# 171136|, Western Cape Mediclinic Constantiaberg /Id# 171137|Dr Jp Wright /Id# 171138|Hospital Universitario Parc Tauli /Id# 159461|Pontevedra Hospital Alvaro Cunqueiro /Id# 167360|Su Molndal. /Id# 202843|Vastra Gotalands Lan AlingsÃ¥s Lasarett /Id# 202074|University Hospital Zurich /Id# 202910|Ankara Univ Medical Faculty /Id# 167210|Kayseri Erciyes University Medical Fac /Id# 171291|Kyivska Oblast Medical Centre Of Ok!Clinic Of International Institute Of Clinical Trials /Id# 205482|Regional Clinical Hospital /Id# 203367|, Devon Rd&E Hospital /Id# 157587|Barnsley Hospital Nhs Foundation Trust /Id# 202770|Ucsd /Id# 160452|Peak Gastroenterology Associat /Id# 165841|Medical Research Ctr Ct /Id# 160311|South Lake Pain Institute, Inc /Id# 162878|Emory University Hospital /Id# 160583|University Of Chicago /Id# 160521|Indiana University /Id# 167252|Cotton-O'Neil Clinical Res Ctr /Id# 160412|Houma Digestive Health Special /Id# 158317|Mgh Digestive Health Center /Id# 164255|Center For Digestive Health /Id# 160327|Mayo Clinic - Rochester /Id# 200458|Quality Clinical Research Inc. /Id# 167313|Comprehensive Digestive Instit /Id# 160178|Concorde Medical Group Pllc /Id# 211805|Carolinas Medical Center /Id# 158512|Plains Clinical Research Center, Llc /Id# 169732|Cleveland Clinic Foundation /Id# 209232|Digestive Disease Specialists /Id# 170779|University Of Pennsylvania /Id# 166266|Gastroenterology Associates, P.A. /Id# 160472|Gastro One /Id# 160418|Inquest Clinical Research /Id# 165685|Advanced Research Institute /Id# 160480|Pediatric Specialty Of Va /Id# 166820|Virginia Mason Medical Center /Id# 160466",{"$nulls":3},"AbbVie Inc.","2019-02-27","2020-05-25T16:36:36.474","2020-05-26T17:10:42.972","NCT03398148"]
["5ecbf414307e3d1b1f8d9cd0","NCT03398148","2019-03-19","AbbVie","ABBV","Recruiting","A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy","Risankizumab","IL23 Inhibitor","Yes","['Risankizumab']","No",null,"Phase 2/Phase 3",16,720,"Anticipated","2018-03-07","2020-09-23",{"$nulls":5},"The objectives of Sub-Study 1 are to evaluate the efficacy, safety, and pharmacokinetics of risankizumab as induction treatment in subjects with moderately to severely active ulcerative colitis (UC), and to identify the appropriate induction dose of risankizumab for further evaluation in Sub-Study 2.\n\nThe objective of Sub-Study 2 is to evaluate the efficacy and safety of risankizumab compared to placebo in inducing clinical remission in subjects with moderately to severely active UC.",null,"A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy","M16-067","Ulcerative Colitis (UC)","Colitis|Colitis, Ulcerative","Gastrointestinal Diseases","Gastrointestinal","Experimental|Placebo Comparator","Substudy 1, Induction 2: Double-blind Risankizumab Dose 2|Substudy 2, Induction 1: Open-label Risankizumab Dose 2|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 2, Induction 2: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 2, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 3|Substudy 2, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 1, Induction 1: Open-label Risankizumab Dose 3","Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection in Induction 2.|Participants randomized to receive risankizumab dose 2 administered by intravenous (IV) infusion.|Participants who received placebo with inadequate response in Induction 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.|Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 3 administered by subcutaneous (SC) injection in Induction 2.|Participants randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion.|Participants who received placebo with inadequate response in Induction 1 receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.|Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.|Participants randomized to receive risankizumab dose 3 administered by intravenous (IV) infusion.|Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.|Participants receive risankizumab dose 3 administered by intravenous (IV) infusion.","Drug","risankizumab SC|risankizumab IV|placebo for risankizumab","risankizumab subcutaneous (SC) injection|risankizumab intravenous (IV) infusion|placebo for risankizumab","ABBV-066 | BI 655066","Substudy 1, Induction 2: Double-blind Risankizumab Dose 2|Substudy 2, Induction 1: Open-label Risankizumab Dose 2|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 2, Induction 2: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 2, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 3|Substudy 2, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 1, Induction 1: Open-label Risankizumab Dose 3","\n\n * Male or female aged >=18 to <= 80 years at the Baseline Visit. Where locally permissible, subjects 16 to < 18 years of age who meet the definition of Tanner stage 5 for development at the Baseline Visit\n * Confirmed diagnosis of ulcerative colitis (UC) for at least 3 months prior to Baseline.\n * Active UC as assessed by adapted Mayo Score\n * Demonstrated intolerance or inadequate response to one or more biologic therapies\n * Females must be postmenopausal for more than 2 years or surgically sterile or practicing specific forms of birth control.\n\n","\n\n * Subject with a current diagnosis of Crohn's disease (CD), inflammatory bowel disease-unclassified (IBD-U) or a history of radiation colitis or ischemic colitis.\n * Subject receiving prohibited medications and treatment.\n * Extent of inflammatory disease limited to the rectum as assessed by screening endoscopy.\n * Subject with currently known complications of UC (e.g., megacolon).",{"$nulls":4},"Actual","2018-01-12","Actual","Anticipated","2022-08-29","Anticipated","2019-03-01","2018-01-08","2018-01-08","2019-03-15","Yes","ABBV-066\nBI 655066","Interventional","Treatment","Parallel Assignment","Double (Participant, Investigator)","Randomized","16 Years","80 Years","All",null,"No","Yes\nAbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2016-004677-40","EudraCT Number","Percentage of participants with clinical remission per adapted Mayo Score at Week 12","Clinical remission per adapted Mayo Score.","Week 12","Percentage of participants achieving clinical remission per full Mayo Score at Week 12 in subjects with a full Mayo score of 6 to 12 at Baseline|Ulcerative Colitis Symptom Questionnaire (UC-SQ): Change from Baseline to Week 12|Inflammatory Bowel Disease Questionnaire (IBDQ): Change from Baseline to Week 12|Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue): Change from Baseline to Week 12|Percentage of participants achieving clinical response per adapted Mayo Score at week 12|Percentage of participants with endoscopic remission at Week 12|Percentage of participants achieving clinical response per partial adapted Mayo Score at week 4|Percentage of participants with mucosal healing at Week 12|36-Item Short Form Health Status Survey (SF-36): Change from Baseline to Week 12|Percentage of participants with hospitalization through Week 12|Percentage of participants with Ulcerative Colitis (UC)-related surgeries through Week 12|Percentage of participants with endoscopic improvement at Week 12","Clinical remission per full Mayo Score.|The US-SQ is a patient questionnaire to assess severity of Crohn's symptoms.|The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.|The FACIT-Fatigue is a validated tool that measures an individual's level of fatigue during their usual daily activities over the past week.|Clinical response per adapted Mayo Score.|Endoscopic remission per endoscopy subscore.|Clinical response per partial adapted Mayo Score (without endoscopy).|Mucosal healing defined as endoscopic and histologic remission.|The SF-36 is an indicator of overall health status.|Participants with an event that results in admission to the hospital.|Participants who underwent surgery related to UC.|Endoscopic improvement per endoscopy subscore.","Week 12|Baseline, Week 12|Week 4|12 weeks","abbvieclinicaltrials@abbvie.com","ABBVIE CALL CENTER","847.283.8955",{"$cut":{"chars":21452,"head":"Buenos Aires, Argentina, 1431 Instituto Medico Cer /Id# 168686Quilmes, Argentina, 1878 Sanatorio 9 De Julio S.A. /Id# 167780San Miguel De Tucuman, Argentina, 4000|Rosario, Santa Fe, Argentina, 2000|Graz, Austria, 8036 Lkh Salzburg And Paracelsus /Id# 200685Salzburg, Austria, 5020|St. PÃ¶lten, Niederoesterreich, Austria, 3100|Vienna, Wien, Austria, 1090|Brussels, Bruxelles-Capitale, Belgium, 1070 Cliniques Universitaires Saint Luc /Id# 200039Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200|Liege, Liege, Belgium, 4000|Gent, Oost-Vlaanderen, Belgium, 9000|Jette, Brussels, Belgium, 1090 Uz Leuven /Id# 170812Leuven, Belgium, 3000 Clinique St Joseph /Id# 200250Liege, Belgium, 4000 Az-Delta /Id# 200040Roeselare, Belgium, 8800 Chu Dinant Godinne - Ucl Namur /Id# 200254Yvoir, Belgium, 5530|Goiania, Goias, Brazil, 74535-170|Curitiba, Parana, Brazil, 80810-040|Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903|Botucatu, Sao Paulo, Brazil, 18618-686 Hospital Das Clinicas Da Faculdade De Medicina De RibeirÃ£o Preto - Usp /Id# 157660RibeirÃ£o Preto, Sao Paulo, Brazil, 14048-900 Faculdade De Medicina Do Abc /Id# 163995Santo AndrÃ©, Sao Paulo, Brazil, 09060-870 Kaiser Clinica E Hospital Dia /Id# 157680Sao Jose Do Rio Preto, Sao Paulo, Brazil, 15015-110|Sliven, Bulgaria, 8800 Ii Mhat - Sofia /Id# 200799Sofia, Bulgaria, 1202 Umhat Tsaritsa Joanna - Isul /Id# 209977Sofia, Bulgaria, 1527 Umhat Sv. 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Klinikum Graz /Id# 169053|Niederoesterreich UniversitÃ¤tsklinikum St.PÃ¶lten /Id# 169048|Wien Medical University Of Vienna /Id# 169050|Bruxelles-Capitale Cub Hospital Erasme /Id# 200252|Liege Chu De Liege /Id# 200253|Oost-Vlaanderen Uz Gent /Id# 200251|Uz Brussels /Id# 164176|Goias Instituto Goiano De Gastroenterologia /Id# 157679|Parana Hospital Nossa Senhora Das GraÃ§as /Id# 157671|Rio Grande Do Sul Hospital De Clinicas De Porto Alegre /Id# 157662|Sao Paulo Upeclin Fmb - Unesp /Id# 157690|Mbal \"Hadzhi Dimitar\" /Id# 207945|Alberta University Of Calgary /Id# 169111|British Columbia Fraser Clinical Trials Inc /Id# 169102|Nova Scotia Qeii Health Sciences Centre /Id# 169107|Ontario London Health Sciences Centre /Id# 169103|Quebec Hopital Charles-Lemoyne /Id# 169105|Hospital ClÃ­nico Regional Dr. Guillermo Grant Benavente /Id# 210761|Region Metropolitana De Santiago Complejo Asistencial Dr. Sotero Del Rio /Id# 169385|ValparaÃ­so Centro De Investigaciones ClÃ­nicas ViÃ±a Del Mar /Id# 203607|Cundinamarca Corporacion Hospitalaria Juan Ciudad Sede Denominada Hospital Universitario Mayo /Id# 158717|Instituto De Coloproctologia /Id# 158739|Grad Zagreb Klinicka Bolnica Dubrava Zagreb /Id# 157475|Klinicki Bolnicki Centar Split /Id# 157473|Osjecko-Baranjska Zupanija Klinicki Bolnicki Centar Osijek /Id# 157472|Hovedstaden Bispebjerg Hospital /Id# 208945|Hvidovre Hospital /Id# 202266|SjÃ¦lland Sjaellands Universitets Hospit /Id# 200033|Syddanmark Odense Universitets Hospital /Id# 205602|University Of Alexandria /Id# 200848|Alpes-Maritimes Chu De Nice-Hopital L'Archet Ii /Id# 171577|Chu Amiens Picardie - Site Sud /Id# 171576|Gironde HÃ´pital Haut-LÃ©vÃªque /Id# 171579|Hopital Beaujon /Id# 200092|Loire Chu De Saint Etienne - Hopital Nord /Id# 171580|Baden-Wuerttemberg Universitatsklinikum Mannheim /Id# 162035|Bayern Universitaetsklinikum Erlangen /Id# 159354|Gastroenterologie Am Bayerisch /Id# 159361|Nordrhein-Westfalen Uniklinik Koln /Id# 164991|Schleswig-Holstein Univ Hosp Schleswig-Holstein /Id# 159360|Thueringen Universitaetsklinikum Ulm /Id# 164992|Attiki General Hospital Of Athens Laiko /Id# 206440|General Hospital Of Chest Diseases Of Athens \"Sotiria\" /Id# 170915|Baranya Mohacsi Korhaz /Id# 205347|Borsod-Abauj-Zemplen Miskolci Semmelweis Korhaz Es /Id# 201285|Heves Bugat Pal Korhaz /Id# 202528|Magyar Honvedseg Egeszsegugyi Kozpont /Id# 157329|Pest Obudai Egeszsegugyi Kozpont /Id# 201922|Hadarom Soroka Medical Center /Id# 171100|Rambam Medical Center /Id# 171101|Tel-Aviv Rabin Medical Center /Id# 167403|Yerushalayim Hadassah Ein Kerem Medical Ctr /Id# 171099|Calabria Universita Di Catanzaro Magna Graecia /Id# 200125|Emilia-Romagna Ospedale Sant Orsola Malpighi /Id# 155611|Irccs Aou San Martino-Ist /Id# 164031|Lazio Policlinico Universitario Campus Bio-Medico /Id# 163992|Lombardia Asst Rhodense /Id# 211449|Milano Istituto Clinico Humanitas /Id# 155610|Sicilia A.O. 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["5ecbf414e2561b1b11905d3b","NCT03398148","2019-04-16","AbbVie","ABBV","Recruiting","A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy","Risankizumab","IL23 Inhibitor","Yes","['Risankizumab']","No",null,"Phase 2/Phase 3",16,720,"Anticipated","2018-02-25","2020-09-23",{"$nulls":5},"The objectives of Sub-Study 1 are to evaluate the efficacy, safety, and pharmacokinetics of risankizumab as induction treatment in subjects with moderately to severely active ulcerative colitis (UC), and to identify the appropriate induction dose of risankizumab for further evaluation in Sub-Study 2.\n\nThe objective of Sub-Study 2 is to evaluate the efficacy and safety of risankizumab compared to placebo in inducing clinical remission in subjects with moderately to severely active UC.",null,"A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy","M16-067","Ulcerative Colitis (UC)","Colitis|Colitis, Ulcerative","Gastrointestinal Diseases","Gastrointestinal","Experimental|Placebo Comparator","Substudy 1, Induction 2: Double-blind Risankizumab Dose 2|Substudy 2, Induction 1: Open-label Risankizumab Dose 2|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 2, Induction 2: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 2, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 3|Substudy 2, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 1, Induction 1: Open-label Risankizumab Dose 3","Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection in Induction 2.|Participants randomized to receive risankizumab dose 2 administered by intravenous (IV) infusion.|Participants who received placebo with inadequate response in Induction 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.|Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 3 administered by subcutaneous (SC) injection in Induction 2.|Participants randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion.|Participants who received placebo with inadequate response in Induction 1 receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.|Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.|Participants randomized to receive risankizumab dose 3 administered by intravenous (IV) infusion.|Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.|Participants receive risankizumab dose 3 administered by intravenous (IV) infusion.","Drug","risankizumab SC|risankizumab IV|placebo for risankizumab","risankizumab subcutaneous (SC) injection|risankizumab intravenous (IV) infusion|placebo for risankizumab","ABBV-066 | BI 655066","Substudy 1, Induction 2: Double-blind Risankizumab Dose 2|Substudy 2, Induction 1: Open-label Risankizumab Dose 2|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 2, Induction 2: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 2, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 3|Substudy 2, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 1, Induction 1: Open-label Risankizumab Dose 3","\n\n * Male or female aged >=18 to <= 80 years at the Baseline Visit. Where locally permissible, subjects 16 to < 18 years of age who meet the definition of Tanner stage 5 for development at the Baseline Visit\n * Confirmed diagnosis of ulcerative colitis (UC) for at least 3 months prior to Baseline.\n * Active UC as assessed by adapted Mayo Score\n * Demonstrated intolerance or inadequate response to one or more biologic therapies\n * Females must be postmenopausal for more than 2 years or surgically sterile or practicing specific forms of birth control.\n\n","\n\n * Subject with a current diagnosis of Crohn's disease (CD), inflammatory bowel disease-unclassified (IBD-U) or a history of radiation colitis or ischemic colitis.\n * Subject receiving prohibited medications and treatment.\n * Extent of inflammatory disease limited to the rectum as assessed by screening endoscopy.\n * Subject with currently known complications of UC (e.g., megacolon).",{"$nulls":4},"Actual","2018-01-12","Actual","Anticipated","2022-08-29","Anticipated","2019-04-01","2018-01-08","2018-01-08","2019-04-11","Yes","ABBV-066\nBI 655066","Interventional","Treatment","Parallel Assignment","Double (Participant, Investigator)","Randomized","16 Years","80 Years","All",null,"No","Yes\nAbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2016-004677-40","EudraCT Number","Percentage of participants with clinical remission per adapted Mayo Score at Week 12","Clinical remission per adapted Mayo Score.","Week 12","Percentage of participants achieving clinical remission per full Mayo Score at Week 12 in subjects with a full Mayo score of 6 to 12 at Baseline|Ulcerative Colitis Symptom Questionnaire (UC-SQ): Change from Baseline to Week 12|Inflammatory Bowel Disease Questionnaire (IBDQ): Change from Baseline to Week 12|Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue): Change from Baseline to Week 12|Percentage of participants achieving clinical response per adapted Mayo Score at week 12|Percentage of participants with endoscopic remission at Week 12|Percentage of participants achieving clinical response per partial adapted Mayo Score at week 4|Percentage of participants with mucosal healing at Week 12|36-Item Short Form Health Status Survey (SF-36): Change from Baseline to Week 12|Percentage of participants with hospitalization through Week 12|Percentage of participants with Ulcerative Colitis (UC)-related surgeries through Week 12|Percentage of participants with endoscopic improvement at Week 12","Clinical remission per full Mayo Score.|The US-SQ is a patient questionnaire to assess severity of Crohn's symptoms.|The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.|The FACIT-Fatigue is a validated tool that measures an individual's level of fatigue during their usual daily activities over the past week.|Clinical response per adapted Mayo Score.|Endoscopic remission per endoscopy subscore.|Clinical response per partial adapted Mayo Score (without endoscopy).|Mucosal healing defined as endoscopic and histologic remission.|The SF-36 is an indicator of overall health status.|Participants with an event that results in admission to the hospital.|Participants who underwent surgery related to UC.|Endoscopic improvement per endoscopy subscore.","Week 12|Baseline, Week 12|Week 4|12 weeks","abbvieclinicaltrials@abbvie.com","ABBVIE CALL CENTER","847.283.8955",{"$cut":{"chars":21159,"head":"Buenos Aires, Argentina, 1431 Instituto Medico Cer /Id# 168686Quilmes, Argentina, 1878 Sanatorio 9 De Julio S.A. /Id# 167780San Miguel De Tucuman, Argentina, 4000|Rosario, Santa Fe, Argentina, 2000|Graz, Austria, 8036 Lkh Salzburg And Paracelsus /Id# 200685Salzburg, Austria, 5020|St. PÃ¶lten, Niederoesterreich, Austria, 3100|Vienna, Wien, Austria, 1090|Brussels, Bruxelles-Capitale, Belgium, 1070 Cliniques Universitaires Saint Luc /Id# 200039Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200|Bonheiden, Belgium, 2820 Uz Brussels /Id# 164176Jette, Brussels, Belgium, 1090 Uz Leuven /Id# 170812Leuven, Belgium, 3000 Clinique St Joseph /Id# 200250Liege, Belgium, 4000 Az-Delta /Id# 200040Roeselare, Belgium, 8800 Chu Dinant Godinne - Ucl Namur /Id# 200254Yvoir, Belgium, 5530|Liege, Liege, Belgium, 4000|Gent, Oost-Vlaanderen, Belgium, 9000|Goiania, Goias, Brazil, 74535-170|Curitiba, Parana, Brazil, 80810-040|Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903|Botucatu, Sao Paulo, Brazil, 18618-686 Hospital Das Clinicas Da Faculdade De Medicina De RibeirÃ£o Preto - Usp /Id# 157660RibeirÃ£o Preto, Sao Paulo, Brazil, 14048-900 Faculdade De Medicina Do Abc /Id# 163995Santo AndrÃ©, Sao Paulo, Brazil, 09060-870 Kaiser Clinica E Hospital Dia /Id# 157680Sao Jose Do Rio Preto, Sao Paulo, Brazil, 15015-110|Sliven, Bulgaria, 8800 Ii Mhat - Sofia /Id# 200799Sofia, Bulgaria, 1202 Umhat Tsaritsa Joanna - Isul /Id# 209977Sofia, Bulgaria, 1527 Umhat Sv. 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Klinikum Graz /Id# 169053|Niederoesterreich UniversitÃ¤tsklinikum St.PÃ¶lten /Id# 169048|Wien Medical University Of Vienna /Id# 169050|Bruxelles-Capitale Cub Hospital Erasme /Id# 200252|Imelda Ziekenhuis /Id# 211100|Liege Chu De Liege /Id# 200253|Oost-Vlaanderen Uz Gent /Id# 200251|Goias Instituto Goiano De Gastroenterologia E Endoscopia Digestiva Ltda /Id# 157679|Parana Hospital Nossa Senhora Das GraÃ§as /Id# 157671|Rio Grande Do Sul Hospital De Clinicas De Porto Alegre /Id# 157662|Sao Paulo Upeclin Fmb - Unesp /Id# 157690|Mbal \"Hadzhi Dimitar\" /Id# 207945|Alberta University Of Calgary /Id# 169111|British Columbia Fraser Clinical Trials Inc /Id# 169102|Nova Scotia Qeii Health Sciences Centre /Id# 169107|Ontario London Health Sciences Centre /Id# 169103|Quebec Hopital Charles-Lemoyne /Id# 169105|Hospital ClÃ­nico Regional Dr. Guillermo Grant Benavente /Id# 210761|Region Metropolitana De Santiago Complejo Asistencial Dr. Sotero Del Rio /Id# 169385|Cundinamarca Corporacion Hospitalaria Juan Ciudad Sede Denominada Hospital Universitario Mayo /Id# 158717|Instituto De Coloproctologia /Id# 158739|Grad Zagreb Klinicka Bolnica Dubrava Zagreb /Id# 157475|Klinicki Bolnicki Centar Split /Id# 157473|Osjecko-Baranjska Zupanija Klinicki Bolnicki Centar Osijek /Id# 157472|Hovedstaden Bispebjerg Hospital /Id# 208945|Hvidovre Hospital /Id# 202266|SjÃ¦lland Sjaellands Universitets Hospit /Id# 200033|Syddanmark Odense Universitets Hospital /Id# 205602|University Of Alexandria /Id# 200848|Alpes-Maritimes Chu De Nice-Hopital L'Archet Ii /Id# 171577|Chu Amiens Picardie - Site Sud /Id# 171576|Gironde HÃ´pital Haut-LÃ©vÃªque /Id# 171579|Hopital Beaujon /Id# 200092|Loire Chu De Saint Etienne - Hopital Nord /Id# 171580|Baden-Wuerttemberg Universitatsklinikum Mannheim /Id# 162035|Bayern Universitaetsklinikum Erlangen /Id# 159354|Gastroenterologie Am Bayerisch /Id# 159361|Nordrhein-Westfalen Uniklinik Koln /Id# 164991|Schleswig-Holstein Univ Hosp Schleswig-Holstein /Id# 159360|Thueringen Universitaetsklinikum Ulm /Id# 164992|Attiki General Hospital Of Athens Laiko /Id# 206440|General Hospital Of Chest Diseases Of Athens \"Sotiria\" /Id# 170915|Baranya Mohacsi Korhaz /Id# 205347|Borsod-Abauj-Zemplen Miskolci Semmelweis Korhaz Es /Id# 201285|Heves Bugat Pal Korhaz /Id# 202528|Magyar Honvedseg Egeszsegugyi Kozpont /Id# 157329|Pest Obudai Egeszsegugyi Kozpont /Id# 201922|Hadarom Soroka Medical Center /Id# 171100|Rambam Medical Center /Id# 171101|Tel-Aviv Rabin Medical Center /Id# 167403|Yerushalayim Hadassah Ein Kerem Medical Ctr /Id# 171099|Calabria Universita Di Catanzaro Magna Graecia /Id# 200125|Emilia-Romagna Ospedale Sant Orsola Malpighi /Id# 155611|Irccs Aou San Martino-Ist /Id# 164031|Lazio Policlinico Universitario Campus Bio-Medico /Id# 163992|Lombardia Asst Rhodense /Id# 211449|Milano Istituto Clinico Humanitas /Id# 155610|Sicilia A.O. 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Rooseve /Id# 164347|Univ Medical Ctr Ljubljana /Id# 210627|, Free State Farmovs Integrated Research Solutions /Id# 207537|, Gauteng Wits Clinical Research Site /Id# 171136|, Western Cape Mediclinic Constantiaberg /Id# 171137|Dr Jp Wright /Id# 171138|Hospital Universitario Parc Tauli /Id# 159461|Pontevedra Hospital Alvaro Cunqueiro /Id# 167360|Su Molndal. /Id# 202843|Vastra Gotalands Lan AlingsÃ¥s Lasarett /Id# 202074|University Hospital Zurich /Id# 202910|Ankara Univ Medical Faculty /Id# 167210|Kayseri Erciyes University Medical Fac /Id# 171291|Kyivska Oblast Medical Centre Of Ok!Clinic Of International Institute Of Clinical Trials /Id# 205482|Regional Clinical Hospital /Id# 203367|, Devon Rd&E Hospital /Id# 157587|Barnsley Hospital Nhs Foundation Trust /Id# 202770|Ucsd /Id# 160452|Peak Gastroenterology Associat /Id# 165841|Medical Research Ctr Ct /Id# 160311|South Lake Pain Institute, Inc /Id# 162878|Emory University Hospital /Id# 160583|University Of Chicago /Id# 160521|Indiana University /Id# 167252|Cotton-O'Neil Clinical Res Ctr /Id# 160412|Houma Digestive Health Special /Id# 158317|Mgh Digestive Health Center /Id# 164255|Center For Digestive Health /Id# 160327|Mayo Clinic - Rochester /Id# 200458|Quality Clinical Research Inc. /Id# 167313|Revival Research Institute, Llc /Id# 210989|Concorde Medical Group Pllc /Id# 211805|Carolinas Medical Center /Id# 158512|Plains Clinical Research Center, Llc /Id# 169732|Cleveland Clinic Main Campus /Id# 209232|Digestive Disease Specialists /Id# 170779|University Of Pennsylvania /Id# 166266|Gastroenterology Associates, P.A. /Id# 160472|Gastro One /Id# 160418|Inquest Clinical Research /Id# 165685|Advanced Research Institute /Id# 160480|Pediatric Specialty Of Va /Id# 166820|Virginia Mason Medical Center /Id# 160466",{"$nulls":3},"AbbVie Inc.","2019-04-11","2020-05-25T16:36:36.717","2020-05-26T17:10:42.972","NCT03398148"]
["5ecbf41511702c1b1b916a51","NCT03398148","2019-05-07","AbbVie","ABBV","Recruiting","A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy","Risankizumab","IL23 Inhibitor","No",null,"No",null,"Phase 2/Phase 3",16,720,"Anticipated","2018-02-25","2020-09-23",{"$nulls":5},"The objectives of Sub-Study 1 are to evaluate the efficacy, safety, and pharmacokinetics of risankizumab as induction treatment in subjects with moderately to severely active ulcerative colitis (UC), and to identify the appropriate induction dose of risankizumab for further evaluation in Sub-Study 2.\n\nThe objective of Sub-Study 2 is to evaluate the efficacy and safety of risankizumab compared to placebo in inducing clinical remission in subjects with moderately to severely active UC.",null,"A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy","M16-067","Ulcerative Colitis (UC)","Colitis|Colitis, Ulcerative","Gastrointestinal Diseases","Gastrointestinal","Experimental|Placebo Comparator","Substudy 1, Induction 2: Double-blind Risankizumab Dose 2|Substudy 2, Induction 1: Open-label Risankizumab Dose 2|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 2, Induction 2: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 2, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 3|Substudy 2, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 1, Induction 1: Open-label Risankizumab Dose 3","Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection in Induction 2.|Participants randomized to receive risankizumab dose 2 administered by intravenous (IV) infusion.|Participants who received placebo with inadequate response in Induction 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.|Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 3 administered by subcutaneous (SC) injection in Induction 2.|Participants randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion.|Participants who received placebo with inadequate response in Induction 1 receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.|Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.|Participants randomized to receive risankizumab dose 3 administered by intravenous (IV) infusion.|Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.|Participants receive risankizumab dose 3 administered by intravenous (IV) infusion.","Drug","risankizumab SC|risankizumab IV|placebo for risankizumab","risankizumab subcutaneous (SC) injection|risankizumab intravenous (IV) infusion|placebo for risankizumab","ABBV-066 | BI 655066","Substudy 1, Induction 2: Double-blind Risankizumab Dose 2|Substudy 2, Induction 1: Open-label Risankizumab Dose 2|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 2, Induction 2: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 2, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 3|Substudy 2, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 1, Induction 1: Open-label Risankizumab Dose 3","\n\n * Male or female aged >=18 to <= 80 years at the Baseline Visit. Where locally permissible, subjects 16 to < 18 years of age who meet the definition of Tanner stage 5 for development at the Baseline Visit\n * Confirmed diagnosis of ulcerative colitis (UC) for at least 3 months prior to Baseline.\n * Active UC as assessed by adapted Mayo Score\n * Demonstrated intolerance or inadequate response to one or more biologic therapies\n * Females must be postmenopausal for more than 2 years or surgically sterile or practicing specific forms of birth control.\n\n","\n\n * Subject with a current diagnosis of Crohn's disease (CD), inflammatory bowel disease-unclassified (IBD-U) or a history of radiation colitis or ischemic colitis.\n * Subject receiving prohibited medications and treatment.\n * Extent of inflammatory disease limited to the rectum as assessed by screening endoscopy.\n * Subject with currently known complications of UC (e.g., megacolon).",{"$nulls":4},"Actual","2018-01-12","Actual","Anticipated","2022-08-29","Anticipated","2019-05-01","2018-01-08","2018-01-08","2019-05-03","Yes","ABBV-066\nBI 655066","Interventional","Treatment","Parallel Assignment","Double (Participant, Investigator)","Randomized","16 Years","80 Years","All",null,"No","Yes\nAbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2016-004677-40","EudraCT Number","Percentage of participants with clinical remission per adapted Mayo Score at Week 12","Clinical remission per adapted Mayo Score.","Week 12","Percentage of participants achieving clinical remission per full Mayo Score at Week 12 in subjects with a full Mayo score of 6 to 12 at Baseline|Ulcerative Colitis Symptom Questionnaire (UC-SQ): Change from Baseline to Week 12|Inflammatory Bowel Disease Questionnaire (IBDQ): Change from Baseline to Week 12|Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue): Change from Baseline to Week 12|Percentage of participants achieving clinical response per adapted Mayo Score at week 12|Percentage of participants with endoscopic remission at Week 12|Percentage of participants achieving clinical response per partial adapted Mayo Score at week 4|Percentage of participants with mucosal healing at Week 12|36-Item Short Form Health Status Survey (SF-36): Change from Baseline to Week 12|Percentage of participants with hospitalization through Week 12|Percentage of participants with Ulcerative Colitis (UC)-related surgeries through Week 12|Percentage of participants with endoscopic improvement at Week 12","Clinical remission per full Mayo Score.|The US-SQ is a patient questionnaire to assess severity of Crohn's symptoms.|The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.|The FACIT-Fatigue is a validated tool that measures an individual's level of fatigue during their usual daily activities over the past week.|Clinical response per adapted Mayo Score.|Endoscopic remission per endoscopy subscore.|Clinical response per partial adapted Mayo Score (without endoscopy).|Mucosal healing defined as endoscopic and histologic remission.|The SF-36 is an indicator of overall health status.|Participants with an event that results in admission to the hospital.|Participants who underwent surgery related to UC.|Endoscopic improvement per endoscopy subscore.","Week 12|Baseline, Week 12|Week 4|12 weeks","abbvieclinicaltrials@abbvie.com","ABBVIE CALL CENTER","847.283.8955",{"$cut":{"chars":22027,"head":"Buenos Aires, Argentina, 1431 Instituto Medico Cer /Id# 168686Quilmes, Argentina, 1878 Sanatorio 9 De Julio S.A. /Id# 167780San Miguel De Tucuman, Argentina, 4000|Rosario, Santa Fe, Argentina, 2000|Graz, Austria, 8036 Lkh Salzburg And Paracelsus /Id# 200685Salzburg, Austria, 5020|St. PÃ¶lten, Niederoesterreich, Austria, 3100|Vienna, Wien, Austria, 1090|Brussels, Bruxelles-Capitale, Belgium, 1070 Cliniques Universitaires Saint Luc /Id# 200039Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200|Bonheiden, Belgium, 2820 Uz Brussels /Id# 164176Jette, Brussels, Belgium, 1090 Uz Leuven /Id# 170812Leuven, Belgium, 3000 Clinique St Joseph /Id# 200250Liege, Belgium, 4000 Az-Delta /Id# 200040Roeselare, Belgium, 8800 Chu Dinant Godinne - Ucl Namur /Id# 200254Yvoir, Belgium, 5530|Liege, Liege, Belgium, 4000|Gent, Oost-Vlaanderen, Belgium, 9000|Goiania, Goias, Brazil, 74535-170|Rio De Janeiro, Brazil, 21941-913|Curitiba, Parana, Brazil, 80810-040|Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903|Botucatu, Sao Paulo, Brazil, 18618-686 Hospital Das Clinicas Da Faculdade De Medicina De RibeirÃ£o Preto - Usp /Id# 157660RibeirÃ£o Preto, Sao Paulo, Brazil, 14048-900 Faculdade De Medicina Do Abc /Id# 163995Santo AndrÃ©, Sao Paulo, Brazil, 09060-870 Kaiser Clinica E Hospital Dia /Id# 157680Sao Jose Do Rio Preto, Sao Paulo, Brazil, 15015-110|Sliven, Bulgaria, 8800 Ii Mhat - Sofia /Id# 200799Sofia, Bulgaria, 1202 Umhat Tsaritsa Joanna - Isul /Id# 209977Sofia, Bulgaria, 1527 Umhat Sv. 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["5ecbf415307e3d1b1f8d9cd1","NCT03398148","2019-06-04","AbbVie","ABBV","Recruiting","A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy","Risankizumab","IL23 Inhibitor","No",null,"No",null,"Phase 2/Phase 3",16,720,"Anticipated","2018-02-25","2020-09-23",{"$nulls":5},"The objectives of Sub-Study 1 are to evaluate the efficacy, safety, and pharmacokinetics of risankizumab as induction treatment in subjects with moderately to severely active ulcerative colitis (UC), and to identify the appropriate induction dose of risankizumab for further evaluation in Sub-Study 2.\n\nThe objective of Sub-Study 2 is to evaluate the efficacy and safety of risankizumab compared to placebo in inducing clinical remission in subjects with moderately to severely active UC.",null,"A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy","M16-067","Ulcerative Colitis (UC)","Colitis|Colitis, Ulcerative","Gastrointestinal Diseases","Gastrointestinal","Experimental|Placebo Comparator","Substudy 1, Induction 2: Double-blind Risankizumab Dose 2|Substudy 2, Induction 1: Open-label Risankizumab Dose 2|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 2, Induction 2: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 2, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 3|Substudy 2, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 1, Induction 1: Open-label Risankizumab Dose 3","Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection in Induction 2.|Participants randomized to receive risankizumab dose 2 administered by intravenous (IV) infusion.|Participants who received placebo with inadequate response in Induction 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.|Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 3 administered by subcutaneous (SC) injection in Induction 2.|Participants randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion.|Participants who received placebo with inadequate response in Induction 1 receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.|Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.|Participants randomized to receive risankizumab dose 3 administered by intravenous (IV) infusion.|Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.|Participants receive risankizumab dose 3 administered by intravenous (IV) infusion.","Drug","risankizumab SC|risankizumab IV|placebo for risankizumab","risankizumab subcutaneous (SC) injection|risankizumab intravenous (IV) infusion|placebo for risankizumab","ABBV-066 | BI 655066","Substudy 1, Induction 2: Double-blind Risankizumab Dose 2|Substudy 2, Induction 1: Open-label Risankizumab Dose 2|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 2, Induction 2: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 2, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 3|Substudy 2, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 1, Induction 1: Open-label Risankizumab Dose 3","\n\n * Male or female aged >=18 to <= 80 years at the Baseline Visit. Where locally permissible, subjects 16 to < 18 years of age who meet the definition of Tanner stage 5 for development at the Baseline Visit\n * Confirmed diagnosis of ulcerative colitis (UC) for at least 3 months prior to Baseline.\n * Active UC as assessed by adapted Mayo Score\n * Demonstrated intolerance or inadequate response to one or more biologic therapies\n * Females must be postmenopausal for more than 2 years or surgically sterile or practicing specific forms of birth control.\n\n","\n\n * Subject with a current diagnosis of Crohn's disease (CD), inflammatory bowel disease-unclassified (IBD-U) or a history of radiation colitis or ischemic colitis.\n * Subject receiving prohibited medications and treatment.\n * Extent of inflammatory disease limited to the rectum as assessed by screening endoscopy.\n * Subject with currently known complications of UC (e.g., megacolon).",{"$nulls":4},"Actual","2018-01-12","Actual","Anticipated","2022-08-29","Anticipated","2019-05-01","2018-01-08","2018-01-08","2019-05-31","Yes","ABBV-066\nBI 655066","Interventional","Treatment","Parallel Assignment","Double (Participant, Investigator)","Randomized","16 Years","80 Years","All",null,"No","Yes\nAbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2016-004677-40","EudraCT Number","Percentage of participants with clinical remission per adapted Mayo Score at Week 12","Clinical remission per adapted Mayo Score.","Week 12","Percentage of participants achieving clinical remission per full Mayo Score at Week 12 in subjects with a full Mayo score of 6 to 12 at Baseline|Ulcerative Colitis Symptom Questionnaire (UC-SQ): Change from Baseline to Week 12|Inflammatory Bowel Disease Questionnaire (IBDQ): Change from Baseline to Week 12|Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue): Change from Baseline to Week 12|Percentage of participants achieving clinical response per adapted Mayo Score at week 12|Percentage of participants with endoscopic remission at Week 12|Percentage of participants achieving clinical response per partial adapted Mayo Score at week 4|Percentage of participants with mucosal healing at Week 12|36-Item Short Form Health Status Survey (SF-36): Change from Baseline to Week 12|Percentage of participants with hospitalization through Week 12|Percentage of participants with Ulcerative Colitis (UC)-related surgeries through Week 12|Percentage of participants with endoscopic improvement at Week 12","Clinical remission per full Mayo Score.|The US-SQ is a patient questionnaire to assess severity of Crohn's symptoms.|The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.|The FACIT-Fatigue is a validated tool that measures an individual's level of fatigue during their usual daily activities over the past week.|Clinical response per adapted Mayo Score.|Endoscopic remission per endoscopy subscore.|Clinical response per partial adapted Mayo Score (without endoscopy).|Mucosal healing defined as endoscopic and histologic remission.|The SF-36 is an indicator of overall health status.|Participants with an event that results in admission to the hospital.|Participants who underwent surgery related to UC.|Endoscopic improvement per endoscopy subscore.","Week 12|Baseline, Week 12|Week 4|12 weeks","abbvieclinicaltrials@abbvie.com","ABBVIE CALL CENTER","847.283.8955",{"$cut":{"chars":22325,"head":"Buenos Aires, Argentina, 1431 Instituto Medico Cer /Id# 168686Quilmes, Argentina, 1878 Sanatorio 9 De Julio S.A. /Id# 167780San Miguel De Tucuman, Argentina, 4000|Rosario, Santa Fe, Argentina, 2000|Graz, Austria, 8036 Lkh Salzburg And Paracelsus /Id# 200685Salzburg, Austria, 5020|St. PÃ¶lten, Niederoesterreich, Austria, 3100|Vienna, Wien, Austria, 1090|Brussels, Bruxelles-Capitale, Belgium, 1070 Cliniques Universitaires Saint Luc /Id# 200039Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200|Bonheiden, Belgium, 2820 Uz Brussels /Id# 164176Jette, Brussels, Belgium, 1090 Uz Leuven /Id# 170812Leuven, Belgium, 3000 Clinique St Joseph /Id# 200250Liege, Belgium, 4000 Az-Delta /Id# 200040Roeselare, Belgium, 8800 Chu Dinant Godinne - Ucl Namur /Id# 200254Yvoir, Belgium, 5530|Liege, Liege, Belgium, 4000|Gent, Oost-Vlaanderen, Belgium, 9000|Goiania, Goias, Brazil, 74535-170|Rio De Janeiro, Brazil, 21941-913|Curitiba, Parana, Brazil, 80810-040|Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903|Botucatu, Sao Paulo, Brazil, 18618-686 Hospital Das Clinicas Da Faculdade De Medicina De RibeirÃ£o Preto - Usp /Id# 157660RibeirÃ£o Preto, Sao Paulo, Brazil, 14048-900 Faculdade De Medicina Do Abc /Id# 163995Santo AndrÃ©, Sao Paulo, Brazil, 09060-870 Kaiser Clinica E Hospital Dia /Id# 157680Sao Jose Do Rio Preto, Sao Paulo, Brazil, 15015-110|Sliven, Bulgaria, 8800 Ii Mhat - Sofia /Id# 200799Sofia, Bulgaria, 1202 Umhat Tsaritsa Joanna - Isul /Id# 209977Sofia, Bulgaria, 1527 Umhat Sv. 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Rooseve /Id# 164347|Univ Medical Ctr Ljubljana /Id# 210627|, Free State Farmovs Integrated Research Solutions /Id# 207537|, Gauteng Wits Clinical Research Site /Id# 171136|, Western Cape Mediclinic Constantiaberg /Id# 171137|Dr Jp Wright /Id# 171138|Hospital Universitario Parc Tauli /Id# 159461|Pontevedra Hospital Alvaro Cunqueiro /Id# 167360|Su Molndal. /Id# 202843|Vastra Gotalands Lan AlingsÃ¥s Lasarett /Id# 202074|University Hospital Zurich /Id# 202910|Ankara Univ Medical Faculty /Id# 167210|Istanbul Acibadem Kozyatagi Hospital /Id# 213276|Kayseri Erciyes University Medical Fac /Id# 171291|Kyivska Oblast Medical Centre Of Ok!Clinic Of International Institute Of Clinical Trials /Id# 205482|Regional Clinical Hospital /Id# 203367|, Devon Rd&E Hospital /Id# 157587|Barnsley Hospital Nhs Foundation Trust /Id# 202770|Ucsd /Id# 160452|Peak Gastroenterology Associat /Id# 165841|Medical Research Ctr Ct /Id# 160311|South Lake Pain Institute, Inc /Id# 162878|Emory University Hospital /Id# 160583|University Of Chicago /Id# 160521|Indiana University /Id# 167252|Cotton-O'Neil Clinical Res Ctr /Id# 160412|Houma Digestive Health Special /Id# 158317|Mgh Digestive Health Center /Id# 164255|Center For Digestive Health /Id# 160327|Mayo Clinic - Rochester /Id# 200458|Quality Clinical Research Inc. /Id# 167313|Revival Research Institute, Llc /Id# 210989|Concorde Medical Group Pllc /Id# 211805|Carolinas Medical Center /Id# 158512|Plains Clinical Research Center, Llc /Id# 169732|Cleveland Clinic Main Campus /Id# 209232|Digestive Disease Specialists /Id# 170779|University Of Pennsylvania /Id# 166266|Gastroenterology Associates, P.A. /Id# 160472|Gastro One /Id# 160418|Inquest Clinical Research /Id# 165685|Advanced Research Institute /Id# 160480|Pediatric Specialty Of Va /Id# 166820|Virginia Mason Medical Center /Id# 160466",{"$nulls":3},"AbbVie Inc.","2019-05-31","2020-05-25T16:36:37.076","2020-05-26T17:10:42.972","NCT03398148"]
["5ecbf414fe30261b1a048240","NCT03398148","2019-06-21","AbbVie","ABBV","Recruiting","A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy","Risankizumab","IL23 Inhibitor","No",null,"No",null,"Phase 2/Phase 3",16,720,"Anticipated","2018-02-25","2020-09-23",{"$nulls":5},"The objectives of Sub-Study 1 are to evaluate the efficacy, safety, and pharmacokinetics of risankizumab as induction treatment in subjects with moderately to severely active ulcerative colitis (UC), and to identify the appropriate induction dose of risankizumab for further evaluation in Sub-Study 2.\n\nThe objective of Sub-Study 2 is to evaluate the efficacy and safety of risankizumab compared to placebo in inducing clinical remission in subjects with moderately to severely active UC.",null,"A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy","M16-067","Ulcerative Colitis (UC)","Colitis|Colitis, Ulcerative","Gastrointestinal Diseases","Gastrointestinal","Experimental|Placebo Comparator","Substudy 1, Induction 2: Double-blind Risankizumab Dose 2|Substudy 2, Induction 1: Open-label Risankizumab Dose 2|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 2, Induction 2: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 2, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 3|Substudy 2, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 1, Induction 1: Open-label Risankizumab Dose 3","Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection in Induction 2.|Participants randomized to receive risankizumab dose 2 administered by intravenous (IV) infusion.|Participants who received placebo with inadequate response in Induction 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.|Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 3 administered by subcutaneous (SC) injection in Induction 2.|Participants randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion.|Participants who received placebo with inadequate response in Induction 1 receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.|Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.|Participants randomized to receive risankizumab dose 3 administered by intravenous (IV) infusion.|Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.|Participants receive risankizumab dose 3 administered by intravenous (IV) infusion.","Drug","risankizumab SC|risankizumab IV|placebo for risankizumab","risankizumab subcutaneous (SC) injection|risankizumab intravenous (IV) infusion|placebo for risankizumab","ABBV-066 | BI 655066","Substudy 1, Induction 2: Double-blind Risankizumab Dose 2|Substudy 2, Induction 1: Open-label Risankizumab Dose 2|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 2, Induction 2: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 2, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 3|Substudy 2, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 1, Induction 1: Open-label Risankizumab Dose 3","\n\n * Male or female aged >=18 to <= 80 years at the Baseline Visit. Where locally permissible, subjects 16 to < 18 years of age who meet the definition of Tanner stage 5 for development at the Baseline Visit\n * Confirmed diagnosis of ulcerative colitis (UC) for at least 3 months prior to Baseline.\n * Active UC as assessed by adapted Mayo Score\n * Demonstrated intolerance or inadequate response to one or more biologic therapies\n * Females must be postmenopausal for more than 2 years or surgically sterile or practicing specific forms of birth control.\n\n","\n\n * Subject with a current diagnosis of Crohn's disease (CD), inflammatory bowel disease-unclassified (IBD-U) or a history of radiation colitis or ischemic colitis.\n * Subject receiving prohibited medications and treatment.\n * Extent of inflammatory disease limited to the rectum as assessed by screening endoscopy.\n * Subject with currently known complications of UC (e.g., megacolon).",{"$nulls":4},"Actual","2018-01-12","Actual","Anticipated","2022-08-29","Anticipated","2019-06-01","2018-01-08","2018-01-08","2019-06-20","Yes","ABBV-066\nBI 655066","Interventional","Treatment","Parallel Assignment","Double (Participant, Investigator)","Randomized","16 Years","80 Years","All",null,"No","Yes\nAbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2016-004677-40","EudraCT Number","Percentage of participants with clinical remission per adapted Mayo Score at Week 12","Clinical remission per adapted Mayo Score.","Week 12","Percentage of participants achieving clinical remission per full Mayo Score at Week 12 in subjects with a full Mayo score of 6 to 12 at Baseline|Ulcerative Colitis Symptom Questionnaire (UC-SQ): Change from Baseline to Week 12|Inflammatory Bowel Disease Questionnaire (IBDQ): Change from Baseline to Week 12|Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue): Change from Baseline to Week 12|Percentage of participants achieving clinical response per adapted Mayo Score at week 12|Percentage of participants with endoscopic remission at Week 12|Percentage of participants achieving clinical response per partial adapted Mayo Score at week 4|Percentage of participants with mucosal healing at Week 12|36-Item Short Form Health Status Survey (SF-36): Change from Baseline to Week 12|Percentage of participants with hospitalization through Week 12|Percentage of participants with Ulcerative Colitis (UC)-related surgeries through Week 12|Percentage of participants with endoscopic improvement at Week 12","Clinical remission per full Mayo Score.|The US-SQ is a patient questionnaire to assess severity of Crohn's symptoms.|The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.|The FACIT-Fatigue is a validated tool that measures an individual's level of fatigue during their usual daily activities over the past week.|Clinical response per adapted Mayo Score.|Endoscopic remission per endoscopy subscore.|Clinical response per partial adapted Mayo Score (without endoscopy).|Mucosal healing defined as endoscopic and histologic remission.|The SF-36 is an indicator of overall health status.|Participants with an event that results in admission to the hospital.|Participants who underwent surgery related to UC.|Endoscopic improvement per endoscopy subscore.","Week 12|Baseline, Week 12|Week 4|12 weeks","abbvieclinicaltrials@abbvie.com","ABBVIE CALL CENTER","847.283.8955",{"$cut":{"chars":22050,"head":"Buenos Aires, Argentina, 1431 Instituto Medico Cer /Id# 168686Quilmes, Argentina, 1878 Sanatorio 9 De Julio S.A. /Id# 167780San Miguel De Tucuman, Argentina, 4000|Rosario, Santa Fe, Argentina, 2000|Graz, Austria, 8036 Lkh Salzburg And Paracelsus /Id# 200685Salzburg, Austria, 5020|St. PÃ¶lten, Niederoesterreich, Austria, 3100|Vienna, Wien, Austria, 1090|Brussels, Bruxelles-Capitale, Belgium, 1070 Cliniques Universitaires Saint Luc /Id# 200039Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200|Bonheiden, Belgium, 2820 Uz Brussels /Id# 164176Jette, Brussels, Belgium, 1090 Uz Leuven /Id# 170812Leuven, Belgium, 3000 Clinique St Joseph /Id# 200250Liege, Belgium, 4000 Az-Delta /Id# 200040Roeselare, Belgium, 8800 Chu Dinant Godinne - Ucl Namur /Id# 200254Yvoir, Belgium, 5530|Liege, Liege, Belgium, 4000|Gent, Oost-Vlaanderen, Belgium, 9000|Goiania, Goias, Brazil, 74535-170|Rio De Janeiro, Brazil, 21941-913|Curitiba, Parana, Brazil, 80810-040|Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903|Botucatu, Sao Paulo, Brazil, 18618-686 Hospital Das Clinicas Da Faculdade De Medicina De RibeirÃ£o Preto - Usp /Id# 157660RibeirÃ£o Preto, Sao Paulo, Brazil, 14048-900 Faculdade De Medicina Do Abc /Id# 163995Santo AndrÃ©, Sao Paulo, Brazil, 09060-870 Kaiser Clinica E Hospital Dia /Id# 157680Sao Jose Do Rio Preto, Sao Paulo, Brazil, 15015-110|Sliven, Bulgaria, 8800 Ii Mhat - Sofia /Id# 200799Sofia, Bulgaria, 1202 Umhat Tsaritsa Joanna - Isul /Id# 209977Sofia, Bulgaria, 1527 Umhat Sv. 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Klinikum Graz /Id# 169053|Niederoesterreich UniversitÃ¤tsklinikum St.PÃ¶lten /Id# 169048|Wien Medical University Of Vienna /Id# 169050|Bruxelles-Capitale Cub Hospital Erasme /Id# 200252|Imelda Ziekenhuis /Id# 211100|Liege Chu De Liege /Id# 200253|Oost-Vlaanderen Uz Gent /Id# 200251|Goias Instituto Goiano De Gastroenterologia E Endoscopia Digestiva Ltda /Id# 157679|Hosp U Clementino Fraga Filho /Id# 157661|Parana Hospital Nossa Senhora Das GraÃ§as /Id# 157671|Rio Grande Do Sul Hospital De Clinicas De Porto Alegre /Id# 157662|Sao Paulo Upeclin Fmb - Unesp /Id# 157690|Mbal \"Hadzhi Dimitar\" /Id# 207945|Alberta University Of Calgary /Id# 169111|British Columbia Fraser Clinical Trials Inc /Id# 169102|Nova Scotia Qeii Health Sciences Centre /Id# 169107|Ontario London Health Sciences Centre /Id# 169103|Quebec Hopital Charles-Lemoyne /Id# 169105|Araucania Servicio De Salud AraucanÃ­a Norte Hospital Victoria /Id# 213151|Hospital Guillermo Grant Benavente De ConcepciÃ³n /Id# 210761|Region Metropolitana De Santiago Complejo Asistencial Dr. Sotero Del Rio /Id# 169385|Anhui The First Affiliated Hospital Of Anhui Medical University /Id# 211228|Beijing Friendship Hospital /Id# 211066|Guangdong The Sixty Affiliated Hospital Of Sun Yat-Sen University /Id# 211231|Hebei The Second Hospital Of Hebei Medical University /Id# 213018|Hospital /Id# 211276|Jiangxi 1St Aff Hosp Nanchang Univ /Id# 212183|Jilin The First Hosp Of Jilin Univ /Id# 212278|Medical University /Id# 211646|Shaanxi Xijing Hospital /Id# 211639|Shanghai Ruijin Hospital, Shanghai Jiaotong /Id# 210962|Zhejiang The Second Affiliated Hospital Of Zhejiang University School Of Medicine /Id# 211025|Cundinamarca Corporacion Hospitalaria Juan Ciudad Sede Denominada Hospital Universitario Mayo /Id# 158717|Instituto De Coloproctologia /Id# 158739|Grad Zagreb Klinicka Bolnica Dubrava Zagreb /Id# 157475|Klinicki Bolnicki Centar Split /Id# 157473|Osjecko-Baranjska Zupanija Klinicki Bolnicki Centar Osijek /Id# 157472|Hovedstaden Bispebjerg Hospital /Id# 208945|Hvidovre Hospital /Id# 202266|SjÃ¦lland Sjaellands Universitets Hospit /Id# 200033|Syddanmark Odense Universitets Hospital /Id# 205602|Clinical Research Center, Faculty Of Medicine, Alexandria University. /Id# 200848|Alpes-Maritimes Chu De Nice-Hopital L'Archet Ii /Id# 171577|Chu Amiens Picardie - Site Sud /Id# 171576|Gironde HÃ´pital Haut-LÃ©vÃªque /Id# 171579|Hopital Beaujon /Id# 200092|Loire Chu De Saint Etienne - Hopital Nord /Id# 171580|Baden-Wuerttemberg Universitatsklinikum Mannheim /Id# 162035|Bayern Universitaetsklinikum Erlangen /Id# 159354|Nordrhein-Westfalen Uniklinik Koln /Id# 164991|Praxis Am Bayrischen Platz /Id# 159361|Schleswig-Holstein Univ Hosp Schleswig-Holstein /Id# 159360|Thueringen Universitaetsklinikum Ulm /Id# 164992|Attiki General Hospital Of Athens Laiko /Id# 206440|General Hospital Of Chest Diseases Of Athens Sotiria /Id# 170915|Hadarom Soroka Medical Center /Id# 171100|Rambam Medical Center /Id# 171101|Tel-Aviv Rabin Medical Center /Id# 167403|Yerushalayim Hadassah Ein Kerem Medical Ctr /Id# 171099|Calabria Universita Di Catanzaro Magna Graecia /Id# 200125|Emilia-Romagna Ospedale Sant Orsola Malpighi /Id# 155611|Lazio Policlinico Universitario Campus Bio-Medico /Id# 163992|Lombardia Asst Rhodense /Id# 211449|Milano Istituto Clinico Humanitas /Id# 155610|Ospedale Policlinico San Martino - Irccs /Id# 164031|Sicilia A.O. 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Rooseve /Id# 164347|Univ Medical Ctr Ljubljana /Id# 210627|, Free State Farmovs Integrated Research Solutions /Id# 207537|, Gauteng Wits Clinical Research Site /Id# 171136|, Western Cape Mediclinic Constantiaberg /Id# 171137|Dr Jp Wright /Id# 171138|Hospital Universitario Parc Tauli /Id# 159461|Pontevedra Hospital Alvaro Cunqueiro /Id# 167360|Su Molndal. /Id# 202843|Vastra Gotalands Lan AlingsÃ¥s Lasarett /Id# 202074|University Hospital Zurich /Id# 202910|Ankara Univ Medical Faculty /Id# 167210|Istanbul Acibadem Kozyatagi Hospital /Id# 213276|Kayseri Erciyes University Medical Fac /Id# 171291|Kyivska Oblast Medical Centre Of Ok!Clinic Of International Institute Of Clinical Trials /Id# 205482|Regional Clinical Hospital /Id# 203367|, Devon Rd&E Hospital /Id# 157587|Barnsley Hospital Nhs Foundation Trust /Id# 202770|Ucsd /Id# 160452|Peak Gastroenterology Associat /Id# 165841|Medical Research Ctr Ct /Id# 160311|South Lake Pain Institute, Inc /Id# 162878|Emory University Hospital /Id# 160583|University Of Chicago /Id# 160521|Indiana University /Id# 167252|Cotton-O'Neil Clinical Res Ctr /Id# 160412|Houma Digestive Health Special /Id# 158317|Mgh Digestive Health Center /Id# 164255|Center For Digestive Health /Id# 160327|Mayo Clinic - Rochester /Id# 200458|Quality Clinical Research Inc. /Id# 167313|Revival Research Institute, Llc /Id# 210989|Concorde Medical Group Pllc /Id# 211805|Carolinas Medical Center /Id# 158512|Plains Clinical Research Center, Llc /Id# 169732|Cleveland Clinic Main Campus /Id# 209232|Digestive Disease Specialists /Id# 170779|University Of Pennsylvania /Id# 166266|Gastroenterology Associates, P.A. /Id# 160472|Gastro One /Id# 160418|Inquest Clinical Research /Id# 165685|Advanced Research Institute /Id# 160480|Pediatric Specialty Of Va /Id# 166820|Virginia Mason Medical Center /Id# 160466",{"$nulls":3},"AbbVie Inc.","2019-06-20","2020-05-25T16:36:36.790","2020-05-26T17:10:42.972","NCT03398148"]
["5ecbf415feab101b15530871","NCT03398148","2019-07-22","AbbVie","ABBV","Recruiting","A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy","Risankizumab","IL23 Inhibitor","No",null,"No",null,"Phase 2/Phase 3",16,720,"Anticipated","2018-03-07","2020-09-23",{"$nulls":5},"The objectives of Sub-Study 1 are to evaluate the efficacy, safety, and pharmacokinetics of risankizumab as induction treatment in subjects with moderately to severely active ulcerative colitis (UC), and to identify the appropriate induction dose of risankizumab for further evaluation in Sub-Study 2.\n\nThe objective of Sub-Study 2 is to evaluate the efficacy and safety of risankizumab compared to placebo in inducing clinical remission in subjects with moderately to severely active UC.",null,"A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy","M16-067","Ulcerative Colitis (UC)","Colitis|Colitis, Ulcerative","Gastrointestinal Diseases","Gastrointestinal","Experimental|Placebo Comparator","Substudy 1, Induction 2: Double-blind Risankizumab Dose 2|Substudy 2, Induction 1: Open-label Risankizumab Dose 2|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 2, Induction 2: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 2, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 3|Substudy 2, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 1, Induction 1: Open-label Risankizumab Dose 3","Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection in Induction 2.|Participants randomized to receive risankizumab dose 2 administered by intravenous (IV) infusion.|Participants who received placebo with inadequate response in Induction 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.|Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 3 administered by subcutaneous (SC) injection in Induction 2.|Participants randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion.|Participants who received placebo with inadequate response in Induction 1 receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.|Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.|Participants randomized to receive risankizumab dose 3 administered by intravenous (IV) infusion.|Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.|Participants receive risankizumab dose 3 administered by intravenous (IV) infusion.","Drug","risankizumab SC|risankizumab IV|placebo for risankizumab","risankizumab subcutaneous (SC) injection|risankizumab intravenous (IV) infusion|placebo for risankizumab","ABBV-066 | BI 655066","Substudy 1, Induction 2: Double-blind Risankizumab Dose 2|Substudy 2, Induction 1: Open-label Risankizumab Dose 2|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 2, Induction 2: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 2, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 3|Substudy 2, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 1, Induction 1: Open-label Risankizumab Dose 3","\n\n * Male or female aged >=18 to <= 80 years at the Baseline Visit. Where locally permissible, subjects 16 to < 18 years of age who meet the definition of Tanner stage 5 for development at the Baseline Visit\n * Confirmed diagnosis of ulcerative colitis (UC) for at least 3 months prior to Baseline.\n * Active UC as assessed by adapted Mayo Score\n * Demonstrated intolerance or inadequate response to one or more biologic therapies\n * Females must be postmenopausal for more than 2 years or surgically sterile or practicing specific forms of birth control.\n\n","\n\n * Subject with a current diagnosis of Crohn's disease (CD), inflammatory bowel disease-unclassified (IBD-U) or a history of radiation colitis or ischemic colitis.\n * Subject receiving prohibited medications and treatment.\n * Extent of inflammatory disease limited to the rectum as assessed by screening endoscopy.\n * Subject with currently known complications of UC (e.g., megacolon).",{"$nulls":4},"Actual","2018-01-12","Actual","Anticipated","2022-08-29","Anticipated","2019-07-01","2018-01-08","2018-01-08","2019-07-18","Yes","ABBV-066\nBI 655066","Interventional","Treatment","Parallel Assignment","Double (Participant, Investigator)","Randomized","16 Years","80 Years","All",null,"No","Yes\nAbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2016-004677-40","EudraCT Number","Percentage of participants with clinical remission per adapted Mayo Score at Week 12","Clinical remission per adapted Mayo Score.","Week 12","Percentage of participants achieving clinical remission per full Mayo Score at Week 12 in subjects with a full Mayo score of 6 to 12 at Baseline|Ulcerative Colitis Symptom Questionnaire (UC-SQ): Change from Baseline to Week 12|Inflammatory Bowel Disease Questionnaire (IBDQ): Change from Baseline to Week 12|Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue): Change from Baseline to Week 12|Percentage of participants achieving clinical response per adapted Mayo Score at week 12|Percentage of participants with endoscopic remission at Week 12|Percentage of participants achieving clinical response per partial adapted Mayo Score at week 4|Percentage of participants with mucosal healing at Week 12|36-Item Short Form Health Status Survey (SF-36): Change from Baseline to Week 12|Percentage of participants with hospitalization through Week 12|Percentage of participants with Ulcerative Colitis (UC)-related surgeries through Week 12|Percentage of participants with endoscopic improvement at Week 12","Clinical remission per full Mayo Score.|The US-SQ is a patient questionnaire to assess severity of Crohn's symptoms.|The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.|The FACIT-Fatigue is a validated tool that measures an individual's level of fatigue during their usual daily activities over the past week.|Clinical response per adapted Mayo Score.|Endoscopic remission per endoscopy subscore.|Clinical response per partial adapted Mayo Score (without endoscopy).|Mucosal healing defined as endoscopic and histologic remission.|The SF-36 is an indicator of overall health status.|Participants with an event that results in admission to the hospital.|Participants who underwent surgery related to UC.|Endoscopic improvement per endoscopy subscore.","Week 12|Baseline, Week 12|Week 4|12 weeks","abbvieclinicaltrials@abbvie.com","ABBVIE CALL CENTER","847.283.8955",{"$cut":{"chars":22076,"head":"Buenos Aires, Argentina, 1431 Instituto Medico Cer /Id# 168686Quilmes, Argentina, 1878 Sanatorio 9 De Julio S.A. /Id# 167780San Miguel De Tucuman, Argentina, 4000|Rosario, Santa Fe, Argentina, 2000|Graz, Austria, 8036 Lkh Salzburg And Paracelsus /Id# 200685Salzburg, Austria, 5020|St. PÃ¶lten, Niederoesterreich, Austria, 3100|Vienna, Wien, Austria, 1090|Brussels, Bruxelles-Capitale, Belgium, 1070 Cliniques Universitaires Saint Luc /Id# 200039Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200|Bonheiden, Belgium, 2820 Uz Brussels /Id# 164176Jette, Brussels, Belgium, 1090 Uz Leuven /Id# 170812Leuven, Belgium, 3000 Clinique St Joseph /Id# 200250Liege, Belgium, 4000 Az-Delta /Id# 200040Roeselare, Belgium, 8800 Chu Dinant Godinne - Ucl Namur /Id# 200254Yvoir, Belgium, 5530|Liege, Liege, Belgium, 4000|Gent, Oost-Vlaanderen, Belgium, 9000|Goiania, Goias, Brazil, 74535-170|Rio De Janeiro, Brazil, 21941-913|Curitiba, Parana, Brazil, 80810-040|Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903|Botucatu, Sao Paulo, Brazil, 18618-686 Hospital Das Clinicas Da Faculdade De Medicina De RibeirÃ£o Preto - Usp /Id# 157660RibeirÃ£o Preto, Sao Paulo, Brazil, 14048-900 Faculdade De Medicina Do Abc /Id# 163995Santo AndrÃ©, Sao Paulo, Brazil, 09060-870 Kaiser Clinica E Hospital Dia /Id# 157680Sao Jose Do Rio Preto, Sao Paulo, Brazil, 15015-110|Sliven, Bulgaria, 8800 Ii Mhat - Sofia /Id# 200799Sofia, Bulgaria, 1202 Umhat Tsaritsa Joanna - Isul /Id# 209977Sofia, Bulgaria, 1527 Umhat Sv. 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Klinikum Graz /Id# 169053|Niederoesterreich UniversitÃ¤tsklinikum St.PÃ¶lten /Id# 169048|Wien Medical University Of Vienna /Id# 169050|Bruxelles-Capitale Cub Hospital Erasme /Id# 200252|Imelda Ziekenhuis /Id# 211100|Liege Chu De Liege /Id# 200253|Oost-Vlaanderen Uz Gent /Id# 200251|Goias Instituto Goiano De Gastroenterologia E Endoscopia Digestiva Ltda /Id# 157679|Hosp U Clementino Fraga Filho /Id# 157661|Parana Hospital Nossa Senhora Das GraÃ§as /Id# 157671|Rio Grande Do Sul Hospital De Clinicas De Porto Alegre /Id# 157662|Sao Paulo Upeclin Fmb - Unesp /Id# 157690|Mbal \"Hadzhi Dimitar\" /Id# 207945|Alberta University Of Calgary /Id# 169111|British Columbia Fraser Clinical Trials Inc /Id# 169102|Nova Scotia Iwk Health Center /Id# 169110|Ontario London Health Sciences Centre /Id# 169103|Quebec Hopital Charles-Lemoyne /Id# 169105|Araucania Servicio De Salud AraucanÃ­a Norte Hospital Victoria /Id# 213151|Hospital Guillermo Grant Benavente De ConcepciÃ³n /Id# 210761|Region Metropolitana De Santiago Complejo Asistencial Dr. Sotero Del Rio /Id# 169385|Anhui The First Affiliated Hospital Of Anhui Medical University /Id# 211228|Beijing Friendship Hospital /Id# 211066|Guangdong The Sixty Affiliated Hospital Of Sun Yat-Sen University /Id# 211231|Hebei The Second Hospital Of Hebei Medical University /Id# 213018|Hospital /Id# 211276|Jiangxi 1St Aff Hosp Nanchang Univ /Id# 212183|Jilin The First Hosp Of Jilin Univ /Id# 212278|Medical University /Id# 211646|Ningxia General Hospital Of Ningxia Medical University /Id# 213911|Shaanxi Xijing Hospital /Id# 211639|Shanghai Ruijin Hospital, Shanghai Jiaotong /Id# 210962|Zhejiang The Second Affiliated Hospital Of Zhejiang University School Of Medicine /Id# 211025|Cundinamarca Corporacion Hospitalaria Juan Ciudad Sede Denominada Hospital Universitario Mayo /Id# 158717|Instituto De Coloproctologia /Id# 158739|Grad Zagreb Klinicka Bolnica Dubrava Zagreb /Id# 157475|Klinicki Bolnicki Centar Split /Id# 157473|Osjecko-Baranjska Zupanija Klinicki Bolnicki Centar Osijek /Id# 157472|Hovedstaden Bispebjerg Hospital /Id# 208945|Hvidovre Hospital /Id# 202266|SjÃ¦lland Sjaellands Universitets Hospit /Id# 200033|Syddanmark Odense Universitets Hospital /Id# 205602|Clinical Research Center, Faculty Of Medicine, Alexandria University. /Id# 200848|Alpes-Maritimes Chu De Nice-Hopital L'Archet Ii /Id# 171577|Chu Amiens Picardie - Site Sud /Id# 171576|Gironde HÃ´pital Haut-LÃ©vÃªque /Id# 171579|Hopital Beaujon /Id# 200092|Loire Chu De Saint Etienne - Hopital Nord /Id# 171580|Baden-Wuerttemberg Universitatsklinikum Mannheim /Id# 162035|Bayern Universitaetsklinikum Erlangen /Id# 159354|Nordrhein-Westfalen Uniklinik Koln /Id# 164991|Praxis Am Bayrischen Platz /Id# 159361|Schleswig-Holstein Univ Hosp Schleswig-Holstein /Id# 159360|Thueringen Universitaetsklinikum Ulm /Id# 164992|Attiki General Hospital Of Athens Laiko /Id# 206440|General Hospital Of Chest Diseases Of Athens Sotiria /Id# 170915|Hadarom Soroka Medical Center /Id# 171100|Rambam Medical Center /Id# 171101|Tel-Aviv Rabin Medical Center /Id# 167403|Yerushalayim Hadassah Ein Kerem Medical Ctr /Id# 171099|Calabria Universita Di Catanzaro Magna Graecia /Id# 200125|Emilia-Romagna Ospedale Sant Orsola Malpighi /Id# 155611|Lazio Policlinico Universitario Campus Bio-Medico /Id# 163992|Lombardia Asst Rhodense /Id# 211449|Milano Istituto Clinico Humanitas /Id# 155610|Ospedale Policlinico San Martino - Irccs /Id# 164031|Sicilia A.O. 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Jana Pawla Ii /Id# 211047|Chuc- Centro Hospitalar E Univ /Id# 166054|Faro Centro Hospitalar Do Algarve - Hospital De PortimÃ£o /Id# 166551|Lisboa Centro Hosp De Lisboa Central /Id# 165582|Setubal Hospital Garcia De Orta, E.P.E /Id# 165583|Institutul Clinic Fundeni /Id# 171264|Southern California Res. Ctr. /Id# 169660|/Id# 200152|Sumadijski Okrug Clinical Center Kragujevac /Id# 156913|Fn S Poliklinikou F.D. Rooseve /Id# 164347|Univ Medical Ctr Ljubljana /Id# 210627|, Free State Farmovs (Pty) Ltd /Id# 207537|, Gauteng Wits Clinical Research Site /Id# 171136|, Western Cape Mediclinic Constantiaberg /Id# 171137|Dr Jp Wright /Id# 171138|Hospital Universitario Parc Tauli /Id# 159461|Pontevedra Hospital Alvaro Cunqueiro /Id# 167360|Su Molndal. /Id# 202843|Vastra Gotalands Lan AlingsÃ¥s Lasarett /Id# 202074|University Hospital Zurich /Id# 202910|Ankara Univ Medical Faculty /Id# 167210|Istanbul Acibadem Kozyatagi Hospital /Id# 213276|Kayseri Erciyes University Medical Fac /Id# 171291|Kyivska Oblast Medical Centre Of Ok!Clinic Of International Institute Of Clinical Trials /Id# 205482|Regional Clinical Hospital /Id# 203367|, Devon Rd&E Hospital /Id# 157587|Barnsley Hospital Nhs Foundation Trust /Id# 202770|Ucsd /Id# 160452|Peak Gastroenterology Associat /Id# 165841|Medical Research Ctr Ct /Id# 160311|South Lake Pain Institute, Inc /Id# 162878|Emory University Hospital /Id# 160583|University Of Chicago /Id# 160521|Indiana University /Id# 167252|Cotton-O'Neil Clinical Res Ctr /Id# 160412|Houma Digestive Health Special /Id# 158317|Mgh Digestive Health Center /Id# 164255|University Of Michigan Hospitals /Id# 158524|Mayo Clinic - Rochester /Id# 200458|Quality Clinical Research Inc. /Id# 167313|Revival Research Institute, Llc /Id# 210989|Concorde Medical Group Pllc /Id# 211805|Carolinas Medical Center /Id# 158512|Plains Clinical Research Center, Llc /Id# 169732|Cleveland Clinic Main Campus /Id# 209232|Digestive Disease Specialists /Id# 170779|University Of Pennsylvania /Id# 166266|Gastroenterology Associates, P.A. /Id# 160472|Gastro One /Id# 160418|Inquest Clinical Research /Id# 165685|Advanced Research Institute /Id# 160480|Pediatric Specialty Of Va /Id# 166820|Virginia Mason Medical Center /Id# 160466",{"$nulls":3},"AbbVie Inc.","2019-07-18","2020-05-25T16:36:37.514","2020-05-26T17:10:42.972","NCT03398148"]
["5ecbf415fe30261b1a048241","NCT03398148","2019-08-19","AbbVie","ABBV","Recruiting","A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy","Risankizumab","IL23 Inhibitor","No",null,"No",null,"Phase 2/Phase 3",16,720,"Anticipated","2018-03-07","2020-09-23",{"$nulls":5},"The objectives of Sub-Study 1 are to evaluate the efficacy, safety, and pharmacokinetics of risankizumab as induction treatment in subjects with moderately to severely active ulcerative colitis (UC), and to identify the appropriate induction dose of risankizumab for further evaluation in Sub-Study 2.\n\nThe objective of Sub-Study 2 is to evaluate the efficacy and safety of risankizumab compared to placebo in inducing clinical remission in subjects with moderately to severely active UC.",null,"A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy","M16-067","Ulcerative Colitis (UC)","Colitis|Colitis, Ulcerative","Gastrointestinal Diseases","Gastrointestinal","Experimental|Placebo Comparator","Substudy 1, Induction 2: Double-blind Risankizumab Dose 2|Substudy 2, Induction 1: Open-label Risankizumab Dose 2|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 2, Induction 2: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 2, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 3|Substudy 2, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 1, Induction 1: Open-label Risankizumab Dose 3","Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection in Induction 2.|Participants randomized to receive risankizumab dose 2 administered by intravenous (IV) infusion.|Participants who received placebo with inadequate response in Induction 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.|Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 3 administered by subcutaneous (SC) injection in Induction 2.|Participants randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion.|Participants who received placebo with inadequate response in Induction 1 receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.|Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.|Participants randomized to receive risankizumab dose 3 administered by intravenous (IV) infusion.|Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.|Participants receive risankizumab dose 3 administered by intravenous (IV) infusion.","Drug","risankizumab SC|risankizumab IV|placebo for risankizumab","risankizumab subcutaneous (SC) injection|risankizumab intravenous (IV) infusion|placebo for risankizumab","ABBV-066 | BI 655066","Substudy 1, Induction 2: Double-blind Risankizumab Dose 2|Substudy 2, Induction 1: Open-label Risankizumab Dose 2|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 2, Induction 2: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 2, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 3|Substudy 2, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 1, Induction 1: Open-label Risankizumab Dose 3","\n\n * Male or female aged >=18 to <= 80 years at the Baseline Visit. Where locally permissible, subjects 16 to < 18 years of age who meet the definition of Tanner stage 5 for development at the Baseline Visit\n * Confirmed diagnosis of ulcerative colitis (UC) for at least 3 months prior to Baseline.\n * Active UC as assessed by adapted Mayo Score\n * Demonstrated intolerance or inadequate response to one or more biologic therapies\n * Females must be postmenopausal for more than 2 years or surgically sterile or practicing specific forms of birth control.\n\n","\n\n * Subject with a current diagnosis of Crohn's disease (CD), inflammatory bowel disease-unclassified (IBD-U) or a history of radiation colitis or ischemic colitis.\n * Subject receiving prohibited medications and treatment.\n * Extent of inflammatory disease limited to the rectum as assessed by screening endoscopy.\n * Subject with currently known complications of UC (e.g., megacolon).",{"$nulls":4},"Actual","2018-01-12","Actual","Anticipated","2022-08-29","Anticipated","2019-08-01","2018-01-08","2018-01-08","2019-08-16","Yes","ABBV-066\nBI 655066","Interventional","Treatment","Parallel Assignment","Double (Participant, Investigator)","Randomized","16 Years","80 Years","All",null,"No","Yes\nAbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2016-004677-40","EudraCT Number","Percentage of participants with clinical remission per adapted Mayo Score at Week 12","Clinical remission per adapted Mayo Score.","Week 12","Percentage of participants achieving clinical remission per full Mayo Score at Week 12 in subjects with a full Mayo score of 6 to 12 at Baseline|Ulcerative Colitis Symptom Questionnaire (UC-SQ): Change from Baseline to Week 12|Inflammatory Bowel Disease Questionnaire (IBDQ): Change from Baseline to Week 12|Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue): Change from Baseline to Week 12|Percentage of participants achieving clinical response per adapted Mayo Score at week 12|Percentage of participants with endoscopic remission at Week 12|Percentage of participants achieving clinical response per partial adapted Mayo Score at week 4|Percentage of participants with mucosal healing at Week 12|36-Item Short Form Health Status Survey (SF-36): Change from Baseline to Week 12|Percentage of participants with hospitalization through Week 12|Percentage of participants with Ulcerative Colitis (UC)-related surgeries through Week 12|Percentage of participants with endoscopic improvement at Week 12","Clinical remission per full Mayo Score.|The US-SQ is a patient questionnaire to assess severity of Crohn's symptoms.|The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.|The FACIT-Fatigue is a validated tool that measures an individual's level of fatigue during their usual daily activities over the past week.|Clinical response per adapted Mayo Score.|Endoscopic remission per endoscopy subscore.|Clinical response per partial adapted Mayo Score (without endoscopy).|Mucosal healing defined as endoscopic and histologic remission.|The SF-36 is an indicator of overall health status.|Participants with an event that results in admission to the hospital.|Participants who underwent surgery related to UC.|Endoscopic improvement per endoscopy subscore.","Week 12|Baseline, Week 12|Week 4|12 weeks","abbvieclinicaltrials@abbvie.com","ABBVIE CALL CENTER","847.283.8955",{"$cut":{"chars":21971,"head":"Buenos Aires, Argentina, 1431 Instituto Medico Cer /Id# 168686Quilmes, Argentina, 1878 Sanatorio 9 De Julio S.A. /Id# 167780San Miguel De Tucuman, Argentina, 4000|Rosario, Santa Fe, Argentina, 2000|Graz, Austria, 8036 Lkh Salzburg And Paracelsus /Id# 200685Salzburg, Austria, 5020|St. PÃ¶lten, Niederoesterreich, Austria, 3100|Vienna, Wien, Austria, 1090|Brussels, Bruxelles-Capitale, Belgium, 1070 Cliniques Universitaires Saint Luc /Id# 200039Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200|Bonheiden, Belgium, 2820 Uz Brussels /Id# 164176Jette, Brussels, Belgium, 1090 Uz Leuven /Id# 170812Leuven, Belgium, 3000 Clinique St Joseph /Id# 200250Liege, Belgium, 4000 Az-Delta /Id# 200040Roeselare, Belgium, 8800 Chu Dinant Godinne - Ucl Namur /Id# 200254Yvoir, Belgium, 5530|Liege, Liege, Belgium, 4000|Gent, Oost-Vlaanderen, Belgium, 9000|Goiania, Goias, Brazil, 74535-170|Rio De Janeiro, Brazil, 21941-913|Curitiba, Parana, Brazil, 80810-040|Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903|Botucatu, Sao Paulo, Brazil, 18618-686 Hospital Das Clinicas Da Faculdade De Medicina De RibeirÃ£o Preto - Usp /Id# 157660RibeirÃ£o Preto, Sao Paulo, Brazil, 14048-900 Faculdade De Medicina Do Abc /Id# 163995Santo AndrÃ©, Sao Paulo, Brazil, 09060-870 Kaiser Clinica E Hospital Dia /Id# 157680Sao Jose Do Rio Preto, Sao Paulo, Brazil, 15015-110|Sliven, Bulgaria, 8800 Ii Mhat - Sofia /Id# 200799Sofia, Bulgaria, 1202 Umhat Tsaritsa Joanna - Isul /Id# 209977Sofia, Bulgaria, 1527 Umhat Sv. 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Klinikum Graz /Id# 169053|Niederoesterreich UniversitÃ¤tsklinikum St.PÃ¶lten /Id# 169048|Wien Medical University Of Vienna /Id# 169050|Bruxelles-Capitale Cub Hospital Erasme /Id# 200252|Imelda Ziekenhuis /Id# 211100|Liege Chu De Liege /Id# 200253|Oost-Vlaanderen Uz Gent /Id# 200251|Goias Instituto Goiano De Gastroenterologia E Endoscopia Digestiva Ltda /Id# 157679|Hosp U Clementino Fraga Filho /Id# 157661|Parana Hospital Nossa Senhora Das GraÃ§as /Id# 157671|Rio Grande Do Sul Hospital De Clinicas De Porto Alegre /Id# 157662|Sao Paulo Upeclin Fmb - Unesp /Id# 157690|Mbal \"Hadzhi Dimitar\" /Id# 207945|Alberta University Of Calgary /Id# 169111|British Columbia Fraser Clinical Trials Inc /Id# 169102|Nova Scotia Iwk Health Center /Id# 169110|Ontario London Health Sciences Centre /Id# 169103|Quebec Hopital Charles-Lemoyne /Id# 169105|Araucania Servicio De Salud AraucanÃ­a Norte Hospital Victoria /Id# 213151|Hospital Guillermo Grant Benavente De ConcepciÃ³n /Id# 210761|Region Metropolitana De Santiago Complejo Asistencial Dr. Sotero Del Rio /Id# 169385|Anhui The First Affiliated Hospital Of Anhui Medical University /Id# 211228|Beijing Friendship Hospital /Id# 211066|Guangdong The Sixty Affiliated Hospital Of Sun Yat-Sen University /Id# 211231|Hebei The Second Hospital Of Hebei Medical University /Id# 213018|Hospital /Id# 211276|Hunan Xiangya Hospital Central South University /Id# 211197|Jiangxi 1St Aff Hosp Nanchang Univ /Id# 212183|Jilin The First Hosp Of Jilin Univ /Id# 212278|Medical University /Id# 211646|Ningxia General Hospital Of Ningxia Medical University /Id# 213911|Shaanxi Xijing Hospital /Id# 211639|Shanghai Ruijin Hospital, Shanghai Jiaotong /Id# 210962|Zhejiang The Second Affiliated Hospital Of Zhejiang University School Of Medicine /Id# 211025|Cundinamarca Corporacion Hospitalaria Juan Ciudad Sede Denominada Hospital Universitario Mayo /Id# 158717|Instituto De Coloproctologia /Id# 158739|Grad Zagreb Klinicka Bolnica Dubrava Zagreb /Id# 157475|Klinicki Bolnicki Centar Split /Id# 157473|Osjecko-Baranjska Zupanija Klinicki Bolnicki Centar Osijek /Id# 157472|Hovedstaden Bispebjerg Hospital /Id# 208945|Hvidovre Hospital /Id# 202266|SjÃ¦lland Sjaellands Universitets Hospit /Id# 200033|Syddanmark Odense Universitets Hospital /Id# 205602|Clinical Research Center, Faculty Of Medicine, Alexandria University. /Id# 200848|Alpes-Maritimes Chu De Nice-Hopital L'Archet Ii /Id# 171577|Chu Amiens Picardie - Site Sud /Id# 171576|Gironde HÃ´pital Haut-LÃ©vÃªque /Id# 171579|Hopital Beaujon /Id# 200092|Loire Chu De Saint Etienne - Hopital Nord /Id# 171580|Baden-Wuerttemberg Universitatsklinikum Mannheim /Id# 162035|Bayern Universitaetsklinikum Erlangen /Id# 159354|Nordrhein-Westfalen Uniklinik Koln /Id# 164991|Praxis Am Bayrischen Platz /Id# 159361|Schleswig-Holstein Univ Hosp Schleswig-Holstein /Id# 159360|Thueringen Universitaetsklinikum Ulm /Id# 164992|Attiki General Hospital Of Athens Laiko /Id# 206440|General Hospital Of Chest Diseases Of Athens Sotiria /Id# 170915|Hadarom Soroka Medical Center /Id# 171100|Rambam Medical Center /Id# 171101|Tel-Aviv Rabin Medical Center /Id# 167403|Yerushalayim Hadassah Ein Kerem Medical Ctr /Id# 171099|Calabria Universita Di Catanzaro Magna Graecia /Id# 200125|Emilia-Romagna Ospedale Sant Orsola Malpighi /Id# 155611|Lazio Policlinico Universitario Campus Bio-Medico /Id# 163992|Lombardia Asst Rhodense /Id# 211449|Milano Istituto Clinico Humanitas /Id# 155610|Ospedale Policlinico San Martino - Irccs /Id# 164031|Sicilia A.O. 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Rooseve /Id# 164347|Univ Medical Ctr Ljubljana /Id# 210627|, Free State Farmovs (Pty) Ltd /Id# 207537|, Gauteng Wits Clinical Research Site /Id# 171136|, Western Cape Mediclinic Constantiaberg /Id# 171137|Dr Jp Wright /Id# 171138|Hospital Universitario Parc Tauli /Id# 159461|Pontevedra Hospital Alvaro Cunqueiro /Id# 167360|Su Molndal. /Id# 202843|Vastra Gotalands Lan AlingsÃ¥s Lasarett /Id# 202074|University Hospital Zurich /Id# 202910|Ankara Univ Medical Faculty /Id# 167210|Istanbul Acibadem Kozyatagi Hospital /Id# 213276|Kayseri Erciyes University Medical Fac /Id# 171291|Kyivska Oblast Medical Centre Of Ok!Clinic Of International Institute Of Clinical Trials /Id# 205482|Regional Clinical Hospital /Id# 203367|, Devon Rd&E Hospital /Id# 157587|Barnsley Hospital Nhs Foundation Trust /Id# 202770|Ucsd /Id# 160452|Peak Gastroenterology Associat /Id# 165841|Medical Research Ctr Ct /Id# 160311|South Lake Pain Institute, Inc /Id# 162878|Gastro Assoc Of Central Ga /Id# 160523|University Of Chicago /Id# 160521|Indiana University /Id# 167252|Cotton-O'Neil Clinical Res Ctr /Id# 160412|Houma Digestive Health Special /Id# 158317|Mgh Digestive Health Center /Id# 164255|University Of Michigan Hospitals /Id# 158524|Mayo Clinic - Rochester /Id# 200458|Quality Clinical Research Inc. /Id# 167313|Revival Research Institute, Llc /Id# 210989|Concorde Medical Group Pllc /Id# 211805|Carolinas Medical Center /Id# 158512|Plains Clinical Research Center, Llc /Id# 169732|Cleveland Clinic Main Campus /Id# 209232|Digestive Disease Specialists /Id# 170779|University Of Pennsylvania /Id# 166266|Gastroenterology Associates, P.A. /Id# 160472|Gastro One /Id# 160418|Inquest Clinical Research /Id# 165685|Advanced Research Institute /Id# 160480|Virginia Mason Medical Center /Id# 160466",{"$nulls":3},"AbbVie Inc.","2019-08-16","2020-05-25T16:36:37.525","2020-05-26T17:10:42.972","NCT03398148"]
["5ecbf415e2561b1b11905d3c","NCT03398148","2019-09-20","AbbVie","ABBV","Recruiting","A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy","Risankizumab","IL23 Inhibitor","No",null,"No",null,"Phase 2/Phase 3",16,720,"Anticipated","2018-03-07","2020-09-23",{"$nulls":5},"The objectives of Sub-Study 1 are to evaluate the efficacy, safety, and pharmacokinetics of risankizumab as induction treatment in subjects with moderately to severely active ulcerative colitis (UC), and to identify the appropriate induction dose of risankizumab for further evaluation in Sub-Study 2.\n\nThe objective of Sub-Study 2 is to evaluate the efficacy and safety of risankizumab compared to placebo in inducing clinical remission in subjects with moderately to severely active UC.",null,"A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy","M16-067","Ulcerative Colitis (UC)","Colitis|Colitis, Ulcerative","Gastrointestinal Diseases","Gastrointestinal","Experimental|Placebo Comparator","Substudy 1, Induction 2: Double-blind Risankizumab Dose 2|Substudy 2, Induction 1: Open-label Risankizumab Dose 2|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 2, Induction 2: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 2, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 3|Substudy 2, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 1, Induction 1: Open-label Risankizumab Dose 3","Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection in Induction 2.|Participants randomized to receive risankizumab dose 2 administered by intravenous (IV) infusion.|Participants who received placebo with inadequate response in Induction 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.|Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 3 administered by subcutaneous (SC) injection in Induction 2.|Participants randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion.|Participants who received placebo with inadequate response in Induction 1 receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.|Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.|Participants randomized to receive risankizumab dose 3 administered by intravenous (IV) infusion.|Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.|Participants receive risankizumab dose 3 administered by intravenous (IV) infusion.","Drug","risankizumab SC|risankizumab IV|placebo for risankizumab","risankizumab subcutaneous (SC) injection|risankizumab intravenous (IV) infusion|placebo for risankizumab","ABBV-066 | BI 655066","Substudy 1, Induction 2: Double-blind Risankizumab Dose 2|Substudy 2, Induction 1: Open-label Risankizumab Dose 2|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 2, Induction 2: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 2, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 3|Substudy 2, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 1, Induction 1: Open-label Risankizumab Dose 3","\n\n * Male or female aged >=18 to <= 80 years at the Baseline Visit. Where locally permissible, subjects 16 to < 18 years of age who meet the definition of Tanner stage 5 for development at the Baseline Visit\n * Confirmed diagnosis of ulcerative colitis (UC) for at least 3 months prior to Baseline.\n * Active UC as assessed by adapted Mayo Score\n * Demonstrated intolerance or inadequate response to one or more biologic therapies\n * Females must be postmenopausal for more than 2 years or surgically sterile or practicing specific forms of birth control.\n\n","\n\n * Subject with a current diagnosis of Crohn's disease (CD), inflammatory bowel disease-unclassified (IBD-U) or a history of radiation colitis or ischemic colitis.\n * Subject receiving prohibited medications and treatment.\n * Extent of inflammatory disease limited to the rectum as assessed by screening endoscopy.\n * Subject with currently known complications of UC (e.g., megacolon).",{"$nulls":4},"Actual","2018-01-12","Actual","Anticipated","2022-08-29","Anticipated","2019-09-01","2018-01-08","2018-01-08","2019-09-18","Yes","ABBV-066\nBI 655066","Interventional","Treatment","Parallel Assignment","Double (Participant, Investigator)","Randomized","16 Years","80 Years","All",null,"No","Yes\nAbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2016-004677-40","EudraCT Number","Percentage of participants with clinical remission per adapted Mayo Score at Week 12","Clinical remission per adapted Mayo Score.","Week 12","Percentage of participants achieving clinical remission per full Mayo Score at Week 12 in subjects with a full Mayo score of 6 to 12 at Baseline|Ulcerative Colitis Symptom Questionnaire (UC-SQ): Change from Baseline to Week 12|Inflammatory Bowel Disease Questionnaire (IBDQ): Change from Baseline to Week 12|Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue): Change from Baseline to Week 12|Percentage of participants achieving clinical response per adapted Mayo Score at week 12|Percentage of participants with endoscopic remission at Week 12|Percentage of participants achieving clinical response per partial adapted Mayo Score at week 4|Percentage of participants with mucosal healing at Week 12|36-Item Short Form Health Status Survey (SF-36): Change from Baseline to Week 12|Percentage of participants with hospitalization through Week 12|Percentage of participants with Ulcerative Colitis (UC)-related surgeries through Week 12|Percentage of participants with endoscopic improvement at Week 12","Clinical remission per full Mayo Score.|The US-SQ is a patient questionnaire to assess severity of Crohn's symptoms.|The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.|The FACIT-Fatigue is a validated tool that measures an individual's level of fatigue during their usual daily activities over the past week.|Clinical response per adapted Mayo Score.|Endoscopic remission per endoscopy subscore.|Clinical response per partial adapted Mayo Score (without endoscopy).|Mucosal healing defined as endoscopic and histologic remission.|The SF-36 is an indicator of overall health status.|Participants with an event that results in admission to the hospital.|Participants who underwent surgery related to UC.|Endoscopic improvement per endoscopy subscore.","Week 12|Baseline, Week 12|Week 4|12 weeks","abbvieclinicaltrials@abbvie.com","ABBVIE CALL CENTER","847.283.8955",{"$cut":{"chars":22131,"head":"Buenos Aires, Argentina, 1431 Instituto Medico Cer /Id# 168686Quilmes, Argentina, 1878 Sanatorio 9 De Julio S.A. /Id# 167780San Miguel De Tucuman, Argentina, 4000|Rosario, Santa Fe, Argentina, 2000|Graz, Austria, 8036 Lkh Salzburg And Paracelsus /Id# 200685Salzburg, Austria, 5020|St. PÃ¶lten, Niederoesterreich, Austria, 3100|Vienna, Wien, Austria, 1090|Brussels, Bruxelles-Capitale, Belgium, 1070 Cliniques Universitaires Saint Luc /Id# 200039Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200|Bonheiden, Belgium, 2820 Uz Brussels /Id# 164176Jette, Brussels, Belgium, 1090 Uz Leuven /Id# 170812Leuven, Belgium, 3000 Clinique St Joseph /Id# 200250Liege, Belgium, 4000 Az-Delta /Id# 200040Roeselare, Belgium, 8800 Chu Dinant Godinne - Ucl Namur /Id# 200254Yvoir, Belgium, 5530|Liege, Liege, Belgium, 4000|Gent, Oost-Vlaanderen, Belgium, 9000|Goiania, Goias, Brazil, 74535-170|Rio De Janeiro, Brazil, 21941-913|Curitiba, Parana, Brazil, 80810-040|Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903|Botucatu, Sao Paulo, Brazil, 18618-686 Hospital Das Clinicas Da Faculdade De Medicina De RibeirÃ£o Preto - Usp /Id# 157660RibeirÃ£o Preto, Sao Paulo, Brazil, 14048-900 Faculdade De Medicina Do Abc /Id# 163995Santo AndrÃ©, Sao Paulo, Brazil, 09060-870 Kaiser Clinica E Hospital Dia /Id# 157680Sao Jose Do Rio Preto, Sao Paulo, Brazil, 15015-110|Sliven, Bulgaria, 8800 Ii Mhat - Sofia /Id# 200799Sofia, Bulgaria, 1202 Umhat Tsaritsa Joanna - Isul /Id# 209977Sofia, Bulgaria, 1527 Umhat Sv. 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Klinikum Graz /Id# 169053|Niederoesterreich UniversitÃ¤tsklinikum St.PÃ¶lten /Id# 169048|Wien Medical University Of Vienna /Id# 169050|Bruxelles-Capitale Cub Hospital Erasme /Id# 200252|Imelda Ziekenhuis /Id# 211100|Liege Chu De Liege /Id# 200253|Oost-Vlaanderen Uz Gent /Id# 200251|Goias Instituto Goiano De Gastroenterologia E Endoscopia Digestiva Ltda /Id# 157679|Hosp U Clementino Fraga Filho /Id# 157661|Parana Hospital Nossa Senhora Das GraÃ§as /Id# 157671|Rio Grande Do Sul Hospital De Clinicas De Porto Alegre /Id# 157662|Sao Paulo Upeclin Fmb - Unesp /Id# 157690|Mbal \"Hadzhi Dimitar\" /Id# 207945|Alberta University Of Calgary /Id# 169111|British Columbia Fraser Clinical Trials Inc /Id# 169102|Nova Scotia Iwk Health Center /Id# 169110|Ontario London Health Sciences Centre /Id# 169103|Quebec Hopital Charles-Lemoyne /Id# 169105|Araucania Servicio De Salud AraucanÃ­a Norte Hospital Victoria /Id# 213151|Hospital Guillermo Grant Benavente De ConcepciÃ³n /Id# 210761|Region Metropolitana De Santiago Complejo Asistencial Dr. Sotero Del Rio /Id# 169385|Anhui The First Affiliated Hospital Of Anhui Medical University /Id# 211228|Beijing Friendship Hospital /Id# 211066|Guangdong The Sixty Affiliated Hospital Of Sun Yat-Sen University /Id# 211231|Hebei The Second Hospital Of Hebei Medical University /Id# 213018|Hospital /Id# 211276|Hunan Xiangya Hospital Central South University /Id# 211197|Jiangxi 1St Aff Hosp Nanchang Univ /Id# 212183|Jilin The First Hosp Of Jilin Univ /Id# 212278|Medical University /Id# 211646|Ningxia General Hospital Of Ningxia Medical University /Id# 213911|Shaanxi Xijing Hospital /Id# 211639|Shanghai Ruijin Hospital, Shanghai Jiaotong /Id# 210962|Zhejiang The Second Affiliated Hospital Of Zhejiang University School Of Medicine /Id# 211025|Cundinamarca Corporacion Hospitalaria Juan Ciudad Sede Denominada Hospital Universitario Mayo /Id# 158717|Instituto De Coloproctologia /Id# 158739|Grad Zagreb Klinicka Bolnica Dubrava Zagreb /Id# 157475|Klinicki Bolnicki Centar Split /Id# 157473|Osjecko-Baranjska Zupanija Klinicki Bolnicki Centar Osijek /Id# 157472|Hovedstaden Bispebjerg Hospital /Id# 208945|Hvidovre Hospital /Id# 202266|SjÃ¦lland Sjaellands Universitets Hospit /Id# 200033|Syddanmark Odense Universitets Hospital /Id# 205602|Clinical Research Center, Faculty Of Medicine, Alexandria University. /Id# 200848|Alpes-Maritimes Chu De Nice-Hopital L'Archet Ii /Id# 171577|Chu Amiens Picardie - Site Sud /Id# 171576|Gironde HÃ´pital Haut-LÃ©vÃªque /Id# 171579|Hopital Beaujon /Id# 200092|Loire Chu De Saint Etienne - Hopital Nord /Id# 171580|Baden-Wuerttemberg Universitatsklinikum Mannheim /Id# 162035|Bayern Universitaetsklinikum Erlangen /Id# 159354|Nordrhein-Westfalen Uniklinik Koln /Id# 164991|Praxis Am Bayrischen Platz /Id# 159361|Schleswig-Holstein Univ Hosp Schleswig-Holstein /Id# 159360|Thueringen Universitaetsklinikum Ulm /Id# 164992|Attiki General Hospital Of Athens Laiko /Id# 206440|General Hospital Of Chest Diseases Of Athens Sotiria /Id# 170915|Hadarom Soroka Medical Center /Id# 171100|Rambam Medical Center /Id# 171101|Tel-Aviv Rabin Medical Center /Id# 167403|Yerushalayim Hadassah Ein Kerem Medical Ctr /Id# 171099|Calabria Universita Di Catanzaro Magna Graecia /Id# 200125|Emilia-Romagna Ospedale Sant Orsola Malpighi /Id# 155611|Lazio Policlinico Universitario Campus Bio-Medico /Id# 163992|Lombardia Asst Rhodense /Id# 211449|Milano Istituto Clinico Humanitas /Id# 155610|Ospedale Policlinico San Martino - Irccs /Id# 164031|Sicilia A.O. 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Ctr. /Id# 169660|/Id# 200152|Sumadijski Okrug Clinical Center Kragujevac /Id# 156913|Fn S Poliklinikou F.D. Rooseve /Id# 164347|Univ Medical Ctr Ljubljana /Id# 210627|, Free State Farmovs (Pty) Ltd /Id# 207537|, Gauteng Wits Clinical Research Site /Id# 171136|, Western Cape Mediclinic Constantiaberg /Id# 171137|Dr Jp Wright /Id# 171138|Hospital Universitario Parc Tauli /Id# 159461|Pontevedra Hospital Alvaro Cunqueiro /Id# 167360|Su Molndal. /Id# 202843|Vastra Gotalands Lan AlingsÃ¥s Lasarett /Id# 202074|University Hospital Zurich /Id# 202910|Ankara Univ Medical Faculty /Id# 167210|Istanbul Acibadem Kozyatagi Hospital /Id# 213276|Kayseri Erciyes University Medical Fac /Id# 171291|Kyivska Oblast Medical Centre Of Ok!Clinic Of International Institute Of Clinical Trials /Id# 205482|Regional Clinical Hospital /Id# 203367|, Devon Rd&E Hospital /Id# 157587|Barnsley Hospital Nhs Foundation Trust /Id# 202770|Ucsd /Id# 160452|Peak Gastroenterology Associat /Id# 165841|Medical Research Ctr Ct /Id# 160311|South Lake Pain Institute, Inc /Id# 162878|Gastro Assoc Of Central Ga /Id# 160523|University Of Chicago /Id# 160521|Indiana University /Id# 167252|Cotton-O'Neil Clinical Res Ctr /Id# 160412|Houma Digestive Health Special /Id# 158317|Mgh Digestive Health Center /Id# 164255|University Of Michigan Hospitals /Id# 158524|Mayo Clinic - Rochester /Id# 200458|Quality Clinical Research Inc. /Id# 167313|Concorde Medical Group Pllc /Id# 211805|Carolinas Medical Center /Id# 158512|Plains Clinical Research Center, Llc /Id# 169732|Cleveland Clinic Main Campus /Id# 209232|Digestive Disease Specialists /Id# 170779|University Of Pennsylvania /Id# 166266|Gastroenterology Associates, P.A. /Id# 160472|Gastro One /Id# 160418|Inquest Clinical Research /Id# 165685|Advanced Research Institute /Id# 160480|Virginia Mason Medical Center /Id# 160466",{"$nulls":3},"AbbVie Inc.","2019-09-18","2020-05-25T16:36:37.516","2020-05-26T17:10:42.972","NCT03398148"]
["5ecbf415307e3d1b1f8d9cd2","NCT03398148","2019-10-22","AbbVie","ABBV","Recruiting","A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy","Risankizumab","IL23 Inhibitor","No",null,"No",null,"Phase 2/Phase 3",16,720,"Anticipated","2018-03-07","2020-09-23",{"$nulls":5},"The objectives of Sub-Study 1 are to evaluate the efficacy, safety, and pharmacokinetics of risankizumab as induction treatment in subjects with moderately to severely active ulcerative colitis (UC), and to identify the appropriate induction dose of risankizumab for further evaluation in Sub-Study 2.\n\nThe objective of Sub-Study 2 is to evaluate the efficacy and safety of risankizumab compared to placebo in inducing clinical remission in subjects with moderately to severely active UC.",null,"A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy","M16-067","Ulcerative Colitis (UC)","Colitis|Colitis, Ulcerative","Gastrointestinal Diseases","Gastrointestinal","Experimental|Placebo Comparator","Substudy 1, Induction 2: Double-blind Risankizumab Dose 2|Substudy 2, Induction 1: Open-label Risankizumab Dose 2|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 2, Induction 2: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 2, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 3|Substudy 2, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 1, Induction 1: Open-label Risankizumab Dose 3","Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection in Induction 2.|Participants randomized to receive risankizumab dose 2 administered by intravenous (IV) infusion.|Participants who received placebo with inadequate response in Induction 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.|Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 3 administered by subcutaneous (SC) injection in Induction 2.|Participants randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion.|Participants who received placebo with inadequate response in Induction 1 receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.|Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.|Participants randomized to receive risankizumab dose 3 administered by intravenous (IV) infusion.|Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.|Participants receive risankizumab dose 3 administered by intravenous (IV) infusion.","Drug","risankizumab SC|risankizumab IV|placebo for risankizumab","risankizumab subcutaneous (SC) injection|risankizumab intravenous (IV) infusion|placebo for risankizumab","ABBV-066 | BI 655066","Substudy 1, Induction 2: Double-blind Risankizumab Dose 2|Substudy 2, Induction 1: Open-label Risankizumab Dose 2|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 2, Induction 2: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 2, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 3|Substudy 2, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 1, Induction 1: Open-label Risankizumab Dose 3","\n\n * Male or female aged >=18 to <= 80 years at the Baseline Visit. Where locally permissible, subjects 16 to < 18 years of age who meet the definition of Tanner stage 5 for development at the Baseline Visit\n * Confirmed diagnosis of ulcerative colitis (UC) for at least 3 months prior to Baseline.\n * Active UC as assessed by adapted Mayo Score\n * Demonstrated intolerance or inadequate response to one or more biologic therapies\n * Females must be postmenopausal for more than 2 years or surgically sterile or practicing specific forms of birth control.\n\n","\n\n * Subject with a current diagnosis of Crohn's disease (CD), inflammatory bowel disease-unclassified (IBD-U) or a history of radiation colitis or ischemic colitis.\n * Subject receiving prohibited medications and treatment.\n * Extent of inflammatory disease limited to the rectum as assessed by screening endoscopy.\n * Subject with currently known complications of UC (e.g., megacolon).",{"$nulls":4},"Actual","2018-01-12","Actual","Anticipated","2022-08-29","Anticipated","2019-10-01","2018-01-08","2018-01-08","2019-10-18","Yes","ABBV-066\nBI 655066","Interventional","Treatment","Parallel Assignment","Double (Participant, Investigator)","Randomized","16 Years","80 Years","All",null,"No","Yes\nAbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2016-004677-40","EudraCT Number","Percentage of participants with clinical remission per adapted Mayo Score at Week 12","Clinical remission per adapted Mayo Score.","Week 12","Percentage of participants achieving clinical remission per full Mayo Score at Week 12 in subjects with a full Mayo score of 6 to 12 at Baseline|Ulcerative Colitis Symptom Questionnaire (UC-SQ): Change from Baseline to Week 12|Inflammatory Bowel Disease Questionnaire (IBDQ): Change from Baseline to Week 12|Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue): Change from Baseline to Week 12|Percentage of participants achieving clinical response per adapted Mayo Score at week 12|Percentage of participants with endoscopic remission at Week 12|Percentage of participants achieving clinical response per partial adapted Mayo Score at week 4|Percentage of participants with mucosal healing at Week 12|36-Item Short Form Health Status Survey (SF-36): Change from Baseline to Week 12|Percentage of participants with hospitalization through Week 12|Percentage of participants with Ulcerative Colitis (UC)-related surgeries through Week 12|Percentage of participants with endoscopic improvement at Week 12","Clinical remission per full Mayo Score.|The US-SQ is a patient questionnaire to assess severity of Crohn's symptoms.|The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.|The FACIT-Fatigue is a validated tool that measures an individual's level of fatigue during their usual daily activities over the past week.|Clinical response per adapted Mayo Score.|Endoscopic remission per endoscopy subscore.|Clinical response per partial adapted Mayo Score (without endoscopy).|Mucosal healing defined as endoscopic and histologic remission.|The SF-36 is an indicator of overall health status.|Participants with an event that results in admission to the hospital.|Participants who underwent surgery related to UC.|Endoscopic improvement per endoscopy subscore.","Week 12|Baseline, Week 12|Week 4|12 weeks","abbvieclinicaltrials@abbvie.com","ABBVIE CALL CENTER","847.283.8955",{"$cut":{"chars":22300,"head":"Buenos Aires, Argentina, 1431 Sanatorio 9 De Julio S.A. /Id# 167780San Miguel De Tucuman, Argentina, 4000|Rosario, Santa Fe, Argentina, 2000|Graz, Austria, 8036 Lkh Salzburg And Paracelsus /Id# 200685Salzburg, Austria, 5020|St. PÃ¶lten, Niederoesterreich, Austria, 3100|Vienna, Wien, Austria, 1090|Brussels, Bruxelles-Capitale, Belgium, 1070 Cliniques Universitaires Saint Luc /Id# 200039Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200|Bonheiden, Belgium, 2820 Uz Brussels /Id# 164176Jette, Brussels, Belgium, 1090 Uz Leuven /Id# 170812Leuven, Belgium, 3000 Clinique St Joseph /Id# 200250Liege, Belgium, 4000 Az-Delta /Id# 200040Roeselare, Belgium, 8800 Chu Dinant Godinne - Ucl Namur /Id# 200254Yvoir, Belgium, 5530|Liege, Liege, Belgium, 4000|Gent, Oost-Vlaanderen, Belgium, 9000|Goiania, Goias, Brazil, 74535-170|Rio De Janeiro, Brazil, 21941-913|Curitiba, Parana, Brazil, 80810-040|Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903|Botucatu, Sao Paulo, Brazil, 18618-686 Hospital Das Clinicas Da Faculdade De Medicina De RibeirÃ£o Preto - Usp /Id# 157660RibeirÃ£o Preto, Sao Paulo, Brazil, 14048-900 Faculdade De Medicina Do Abc /Id# 163995Santo AndrÃ©, Sao Paulo, Brazil, 09060-870 Kaiser Clinica E Hospital Dia /Id# 157680Sao Jose Do Rio Preto, Sao Paulo, Brazil, 15015-110|Sliven, Bulgaria, 8800 Ii Mhat - Sofia /Id# 200799Sofia, Bulgaria, 1202 Umhat Tsaritsa Joanna - Isul /Id# 209977Sofia, Bulgaria, 1527 Umhat Sv. 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Ctr. /Id# 169660|Peak Gastroenterology Associat /Id# 165841|Medical Research Ctr Ct /Id# 160311|South Lake Pain Institute, Inc /Id# 162878|Atlanta Gastro Assoc /Id# 160415|University Of Chicago /Id# 160521|Indiana University /Id# 167252|Cotton-O'Neil Clinical Res Ctr /Id# 160412|Houma Digestive Health Special /Id# 158317|Mgh Digestive Health Center /Id# 164255|University Of Michigan Hospitals /Id# 158524|Mayo Clinic - Rochester /Id# 200458|Quality Clinical Research Inc. /Id# 167313|Concorde Medical Group Pllc /Id# 211805|Carolinas Medical Center /Id# 158512|Plains Clinical Research Center, Llc /Id# 169732|Cleveland Clinic Main Campus /Id# 209232|Digestive Disease Specialists /Id# 170779|University Of Pennsylvania /Id# 166266|Gastroenterology Associates, P.A. /Id# 160472|Gastro One /Id# 160418|Inquest Clinical Research /Id# 165685|Advanced Research Institute /Id# 160480|Virginia Mason Medical Center /Id# 160466",{"$nulls":3},"AbbVie Inc.","2019-10-18","2020-05-25T16:36:37.926","2020-05-26T17:10:42.972","NCT03398148"]
["5ecbf41511702c1b1b916a52","NCT03398148","2019-11-13","AbbVie","ABBV","Recruiting","A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy","Risankizumab","IL23 Inhibitor","No",null,"No",null,"Phase 2/Phase 3",16,720,"Anticipated","2018-03-07","2020-09-23",{"$nulls":5},"The objectives of Sub-Study 1 are to evaluate the efficacy, safety, and pharmacokinetics of risankizumab as induction treatment in subjects with moderately to severely active ulcerative colitis (UC), and to identify the appropriate induction dose of risankizumab for further evaluation in Sub-Study 2.\n\nThe objective of Sub-Study 2 is to evaluate the efficacy and safety of risankizumab compared to placebo in inducing clinical remission in subjects with moderately to severely active UC.",null,"A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy","M16-067","Ulcerative Colitis (UC)","Colitis|Colitis, Ulcerative","Gastrointestinal Diseases","Gastrointestinal","Experimental|Placebo Comparator","Substudy 1, Induction 2: Double-blind Risankizumab Dose 2|Substudy 2, Induction 1: Open-label Risankizumab Dose 2|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 2, Induction 2: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 2, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 3|Substudy 2, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 1, Induction 1: Open-label Risankizumab Dose 3","Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection in Induction 2.|Participants randomized to receive risankizumab dose 2 administered by intravenous (IV) infusion.|Participants who received placebo with inadequate response in Induction 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.|Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 3 administered by subcutaneous (SC) injection in Induction 2.|Participants randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion.|Participants who received placebo with inadequate response in Induction 1 receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.|Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.|Participants randomized to receive risankizumab dose 3 administered by intravenous (IV) infusion.|Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.|Participants receive risankizumab dose 3 administered by intravenous (IV) infusion.","Drug","risankizumab SC|risankizumab IV|placebo for risankizumab","risankizumab subcutaneous (SC) injection|risankizumab intravenous (IV) infusion|placebo for risankizumab","ABBV-066 | BI 655066","Substudy 1, Induction 2: Double-blind Risankizumab Dose 2|Substudy 2, Induction 1: Open-label Risankizumab Dose 2|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 2, Induction 2: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 2, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 3|Substudy 2, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 1, Induction 1: Open-label Risankizumab Dose 3","\n\n * Male or female aged >=18 to <= 80 years at the Baseline Visit. Where locally permissible, subjects 16 to < 18 years of age who meet the definition of Tanner stage 5 for development at the Baseline Visit\n * Confirmed diagnosis of ulcerative colitis (UC) for at least 3 months prior to Baseline.\n * Active UC as assessed by adapted Mayo Score\n * Demonstrated intolerance or inadequate response to one or more biologic therapies\n * Females must be postmenopausal for more than 2 years or surgically sterile or practicing specific forms of birth control.\n\n","\n\n * Subject with a current diagnosis of Crohn's disease (CD), inflammatory bowel disease-unclassified (IBD-U) or a history of radiation colitis or ischemic colitis.\n * Subject receiving prohibited medications and treatment.\n * Extent of inflammatory disease limited to the rectum as assessed by screening endoscopy.\n * Subject with currently known complications of UC (e.g., megacolon).",{"$nulls":4},"Actual","2018-01-12","Actual","Anticipated","2022-08-29","Anticipated","2019-11-01","2018-01-08","2018-01-08","2019-11-08","Yes","ABBV-066\nBI 655066","Interventional","Treatment","Parallel Assignment","Double (Participant, Investigator)","Randomized","16 Years","80 Years","All",null,"No","Yes\nAbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2016-004677-40","EudraCT Number","Percentage of participants with clinical remission per adapted Mayo Score at Week 12","Clinical remission per adapted Mayo Score.","Week 12","Percentage of participants achieving clinical remission per full Mayo Score at Week 12 in subjects with a full Mayo score of 6 to 12 at Baseline|Ulcerative Colitis Symptom Questionnaire (UC-SQ): Change from Baseline to Week 12|Inflammatory Bowel Disease Questionnaire (IBDQ): Change from Baseline to Week 12|Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue): Change from Baseline to Week 12|Percentage of participants achieving clinical response per adapted Mayo Score at week 12|Percentage of participants with endoscopic remission at Week 12|Percentage of participants achieving clinical response per partial adapted Mayo Score at week 4|Percentage of participants with mucosal healing at Week 12|36-Item Short Form Health Status Survey (SF-36): Change from Baseline to Week 12|Percentage of participants with hospitalization through Week 12|Percentage of participants with Ulcerative Colitis (UC)-related surgeries through Week 12|Percentage of participants with endoscopic improvement at Week 12","Clinical remission per full Mayo Score.|The US-SQ is a patient questionnaire to assess severity of Crohn's symptoms.|The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.|The FACIT-Fatigue is a validated tool that measures an individual's level of fatigue during their usual daily activities over the past week.|Clinical response per adapted Mayo Score.|Endoscopic remission per endoscopy subscore.|Clinical response per partial adapted Mayo Score (without endoscopy).|Mucosal healing defined as endoscopic and histologic remission.|The SF-36 is an indicator of overall health status.|Participants with an event that results in admission to the hospital.|Participants who underwent surgery related to UC.|Endoscopic improvement per endoscopy subscore.","Week 12|Baseline, Week 12|Week 4|12 weeks","abbvieclinicaltrials@abbvie.com","ABBVIE CALL CENTER","847.283.8955",{"$cut":{"chars":22584,"head":"Buenos Aires, Argentina, 1431 Sanatorio 9 De Julio S.A. /Id# 167780San Miguel De Tucuman, Argentina, 4000|Rosario, Santa Fe, Argentina, 2000|Graz, Austria, 8036 Lkh Salzburg And Paracelsus /Id# 200685Salzburg, Austria, 5020|St. PÃ¶lten, Niederoesterreich, Austria, 3100|Linz, Oberoesterreich, Austria, 4010|Vienna, Wien, Austria, 1090|Brussels, Bruxelles-Capitale, Belgium, 1070 Cliniques Universitaires Saint Luc /Id# 200039Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200|Bonheiden, Belgium, 2820 Uz Brussels /Id# 164176Jette, Brussels, Belgium, 1090 Uz Leuven /Id# 170812Leuven, Belgium, 3000 Clinique St Joseph /Id# 200250Liege, Belgium, 4000 Az-Delta /Id# 200040Roeselare, Belgium, 8800 Chu Dinant Godinne - Ucl Namur /Id# 200254Yvoir, Belgium, 5530|Liege, Liege, Belgium, 4000|Gent, Oost-Vlaanderen, Belgium, 9000|Goiania, Goias, Brazil, 74535-170|Rio De Janeiro, Brazil, 21941-913|Curitiba, Parana, Brazil, 80810-040|Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903|Botucatu, Sao Paulo, Brazil, 18618-686 Hospital Das Clinicas Da Faculdade De Medicina De RibeirÃ£o Preto - Usp /Id# 157660RibeirÃ£o Preto, Sao Paulo, Brazil, 14048-900 Faculdade De Medicina Do Abc /Id# 163995Santo AndrÃ©, Sao Paulo, Brazil, 09060-870 Kaiser Clinica E Hospital Dia /Id# 157680Sao Jose Do Rio Preto, Sao Paulo, Brazil, 15015-110|Sliven, Bulgaria, 8800 Ii Mhat - Sofia /Id# 200799Sofia, Bulgaria, 1202 Umhat Tsaritsa Joanna - Isul /Id# 209977Sofia, Bulgaria, 1527 Umhat Sv. 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Ctr. /Id# 169660|Peak Gastroenterology Associat /Id# 165841|Medical Research Ctr Ct /Id# 160311|South Lake Pain Institute, Inc /Id# 162878|Atlanta Gastro Assoc /Id# 160415|University Of Chicago /Id# 160521|Indiana University /Id# 167252|Cotton-O'Neil Clinical Res Ctr /Id# 160412|Houma Digestive Health Special /Id# 158317|Mgh Digestive Health Center /Id# 164255|University Of Michigan Hospitals /Id# 158524|Mayo Clinic - Rochester /Id# 200458|Quality Clinical Research Inc. /Id# 167313|Concorde Medical Group Pllc /Id# 211805|Carolinas Medical Center /Id# 158512|Plains Clinical Research Center, Llc /Id# 169732|Cleveland Clinic Main Campus /Id# 209232|Digestive Disease Specialists /Id# 170779|University Of Pennsylvania /Id# 166266|Gastroenterology Associates, P.A. /Id# 160472|Gastro One /Id# 160418|Inquest Clinical Research /Id# 165685|Advanced Research Institute /Id# 160480|Virginia Mason Medical Center /Id# 160466",{"$nulls":3},"AbbVie Inc.","2019-11-08","2020-05-25T16:36:37.701","2020-05-26T17:10:42.972","NCT03398148"]
["5ecbf416feab101b15530872","NCT03398148","2019-12-06","AbbVie","ABBV","Recruiting","A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy","Risankizumab","IL23 Inhibitor","No",null,"No",null,"Phase 2/Phase 3",16,720,"Anticipated","2018-03-07","2020-09-23",{"$nulls":5},"The objectives of Sub-Study 1 are to evaluate the efficacy, safety, and pharmacokinetics of risankizumab as induction treatment in subjects with moderately to severely active ulcerative colitis (UC), and to identify the appropriate induction dose of risankizumab for further evaluation in Sub-Study 2.\n\nThe objective of Sub-Study 2 is to evaluate the efficacy and safety of risankizumab compared to placebo in inducing clinical remission in subjects with moderately to severely active UC.",null,"A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy","M16-067","Ulcerative Colitis (UC)","Colitis|Colitis, Ulcerative","Gastrointestinal Diseases","Gastrointestinal","Experimental|Placebo Comparator","Substudy 1, Induction 2: Double-blind Risankizumab Dose 2|Substudy 2, Induction 1: Open-label Risankizumab Dose 2|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 2, Induction 2: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 2, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 3|Substudy 2, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 1, Induction 1: Open-label Risankizumab Dose 3","Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection in Induction 2.|Participants randomized to receive risankizumab dose 2 administered by intravenous (IV) infusion.|Participants who received placebo with inadequate response in Induction 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.|Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 3 administered by subcutaneous (SC) injection in Induction 2.|Participants randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion.|Participants who received placebo with inadequate response in Induction 1 receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.|Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.|Participants randomized to receive risankizumab dose 3 administered by intravenous (IV) infusion.|Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.|Participants receive risankizumab dose 3 administered by intravenous (IV) infusion.","Drug","risankizumab SC|risankizumab IV|placebo for risankizumab","risankizumab subcutaneous (SC) injection|risankizumab intravenous (IV) infusion|placebo for risankizumab","ABBV-066 | BI 655066","Substudy 1, Induction 2: Double-blind Risankizumab Dose 2|Substudy 2, Induction 1: Open-label Risankizumab Dose 2|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 2, Induction 2: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 2, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 3|Substudy 2, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 1, Induction 1: Open-label Risankizumab Dose 3","\n\n * Male or female aged >=18 to <= 80 years at the Baseline Visit. Where locally permissible, subjects 16 to < 18 years of age who meet the definition of Tanner stage 5 for development at the Baseline Visit\n * Confirmed diagnosis of ulcerative colitis (UC) for at least 3 months prior to Baseline.\n * Active UC as assessed by adapted Mayo Score\n * Demonstrated intolerance or inadequate response to one or more biologic therapies\n * Females must be postmenopausal for more than 2 years or surgically sterile or practicing specific forms of birth control.\n\n","\n\n * Subject with a current diagnosis of Crohn's disease (CD), inflammatory bowel disease-unclassified (IBD-U) or a history of radiation colitis or ischemic colitis.\n * Subject receiving prohibited medications and treatment.\n * Extent of inflammatory disease limited to the rectum as assessed by screening endoscopy.\n * Subject with currently known complications of UC (e.g., megacolon).",{"$nulls":4},"Actual","2018-01-12","Actual","Anticipated","2022-08-29","Anticipated","2019-12-01","2018-01-08","2018-01-08","2019-12-04","Yes","ABBV-066\nBI 655066","Interventional","Treatment","Parallel Assignment","Double (Participant, Investigator)","Randomized","16 Years","80 Years","All",null,"No","Yes\nAbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2016-004677-40","EudraCT Number","Percentage of participants with clinical remission per adapted Mayo Score at Week 12","Clinical remission per adapted Mayo Score.","Week 12","Percentage of participants achieving clinical remission per full Mayo Score at Week 12 in subjects with a full Mayo score of 6 to 12 at Baseline|Ulcerative Colitis Symptom Questionnaire (UC-SQ): Change from Baseline to Week 12|Inflammatory Bowel Disease Questionnaire (IBDQ): Change from Baseline to Week 12|Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue): Change from Baseline to Week 12|Percentage of participants achieving clinical response per adapted Mayo Score at week 12|Percentage of participants with endoscopic remission at Week 12|Percentage of participants achieving clinical response per partial adapted Mayo Score at week 4|Percentage of participants with mucosal healing at Week 12|36-Item Short Form Health Status Survey (SF-36): Change from Baseline to Week 12|Percentage of participants with hospitalization through Week 12|Percentage of participants with Ulcerative Colitis (UC)-related surgeries through Week 12|Percentage of participants with endoscopic improvement at Week 12","Clinical remission per full Mayo Score.|The US-SQ is a patient questionnaire to assess severity of Crohn's symptoms.|The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.|The FACIT-Fatigue is a validated tool that measures an individual's level of fatigue during their usual daily activities over the past week.|Clinical response per adapted Mayo Score.|Endoscopic remission per endoscopy subscore.|Clinical response per partial adapted Mayo Score (without endoscopy).|Mucosal healing defined as endoscopic and histologic remission.|The SF-36 is an indicator of overall health status.|Participants with an event that results in admission to the hospital.|Participants who underwent surgery related to UC.|Endoscopic improvement per endoscopy subscore.","Week 12|Baseline, Week 12|Week 4|12 weeks","abbvieclinicaltrials@abbvie.com","ABBVIE CALL CENTER","847.283.8955",{"$cut":{"chars":22593,"head":"Buenos Aires, Argentina, 1431 Sanatorio 9 De Julio S.A. /Id# 167780San Miguel De Tucuman, Argentina, 4000|Rosario, Santa Fe, Argentina, 2000|Graz, Austria, 8036 Lkh Salzburg And Paracelsus /Id# 200685Salzburg, Austria, 5020|St. PÃ¶lten, Niederoesterreich, Austria, 3100|Linz, Oberoesterreich, Austria, 4010|Vienna, Wien, Austria, 1090|Brussels, Bruxelles-Capitale, Belgium, 1070 Cliniques Universitaires Saint Luc /Id# 200039Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200|Bonheiden, Belgium, 2820 Uz Brussels /Id# 164176Jette, Brussels, Belgium, 1090 Uz Leuven /Id# 170812Leuven, Belgium, 3000 Clinique St Joseph /Id# 200250Liege, Belgium, 4000 Az-Delta /Id# 200040Roeselare, Belgium, 8800 Chu Dinant Godinne - Ucl Namur /Id# 200254Yvoir, Belgium, 5530|Liege, Liege, Belgium, 4000|Gent, Oost-Vlaanderen, Belgium, 9000|Goiania, Goias, Brazil, 74535-170|Rio De Janeiro, Brazil, 21941-913|Curitiba, Parana, Brazil, 80810-040|Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903|Botucatu, Sao Paulo, Brazil, 18618-686 Hospital Das Clinicas Da Faculdade De Medicina De RibeirÃ£o Preto - Usp /Id# 157660RibeirÃ£o Preto, Sao Paulo, Brazil, 14048-900 Faculdade De Medicina Do Abc /Id# 163995Santo AndrÃ©, Sao Paulo, Brazil, 09060-870 Kaiser Clinica E Hospital Dia /Id# 157680Sao Jose Do Rio Preto, Sao Paulo, Brazil, 15015-110|Sliven, Bulgaria, 8800 Ii Mhat - Sofia /Id# 200799Sofia, Bulgaria, 1202 Umhat Tsaritsa Joanna - Isul /Id# 209977Sofia, Bulgaria, 1527 Umhat Sv. 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Ctr. /Id# 169660|Peak Gastroenterology Associat /Id# 165841|Medical Research Ctr Ct /Id# 160311|South Lake Pain Institute, Inc /Id# 162878|Atlanta Gastro Assoc /Id# 160415|University Of Chicago /Id# 160521|Indiana University /Id# 167252|Cotton-O'Neil Clinical Res Ctr /Id# 160412|Houma Digestive Health Special /Id# 158317|Mgh Digestive Health Center /Id# 164255|University Of Michigan Hospitals /Id# 158524|Mayo Clinic - Rochester /Id# 200458|Quality Clinical Research Inc. /Id# 167313|Concorde Medical Group Pllc /Id# 211805|Carolinas Medical Center /Id# 158512|Plains Clinical Research Center, Llc /Id# 169732|Cleveland Clinic Main Campus /Id# 209232|Digestive Disease Specialists /Id# 170779|University Of Pennsylvania /Id# 166266|Gastroenterology Associates, P.A. /Id# 160472|Gastro One /Id# 160418|Inquest Clinical Research /Id# 165685|Advanced Research Institute /Id# 160480|Virginia Mason Medical Center /Id# 160466",{"$nulls":3},"AbbVie Inc.","2019-12-04","2020-05-25T16:36:38.002","2020-05-26T17:10:42.972","NCT03398148"]
["5ecbf416e2561b1b11905d3d","NCT03398148","2019-12-23","AbbVie","ABBV","Recruiting","A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy","Risankizumab","IL23 Inhibitor","No",null,"No",null,"Phase 2/Phase 3",16,720,"Anticipated","2018-03-07","2020-09-23",{"$nulls":5},"The objectives of Sub-Study 1 are to evaluate the efficacy, safety, and pharmacokinetics of risankizumab as induction treatment in subjects with moderately to severely active ulcerative colitis (UC), and to identify the appropriate induction dose of risankizumab for further evaluation in Sub-Study 2.\n\nThe objective of Sub-Study 2 is to evaluate the efficacy and safety of risankizumab compared to placebo in inducing clinical remission in subjects with moderately to severely active UC.",null,"A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy","M16-067","Ulcerative Colitis (UC)","Colitis|Colitis, Ulcerative","Gastrointestinal Diseases","Gastrointestinal","Experimental|Placebo Comparator","Substudy 1, Induction 2: Double-blind Risankizumab Dose 2|Substudy 2, Induction 1: Open-label Risankizumab Dose 2|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 2, Induction 2: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 2, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 3|Substudy 2, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 1, Induction 1: Open-label Risankizumab Dose 3","Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection in Induction 2.|Participants randomized to receive risankizumab dose 2 administered by intravenous (IV) infusion.|Participants who received placebo with inadequate response in Induction 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.|Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 3 administered by subcutaneous (SC) injection in Induction 2.|Participants randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion.|Participants who received placebo with inadequate response in Induction 1 receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.|Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.|Participants randomized to receive risankizumab dose 3 administered by intravenous (IV) infusion.|Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.|Participants receive risankizumab dose 3 administered by intravenous (IV) infusion.","Drug","risankizumab SC|risankizumab IV|placebo for risankizumab","risankizumab subcutaneous (SC) injection|risankizumab intravenous (IV) infusion|placebo for risankizumab","ABBV-066 | BI 655066","Substudy 1, Induction 2: Double-blind Risankizumab Dose 2|Substudy 2, Induction 1: Open-label Risankizumab Dose 2|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 2, Induction 2: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 2, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 3|Substudy 2, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 1, Induction 1: Open-label Risankizumab Dose 3","\n\n * Male or female aged >=18 to <= 80 years at the Baseline Visit. Where locally permissible, subjects 16 to < 18 years of age who meet the definition of Tanner stage 5 for development at the Baseline Visit\n * Confirmed diagnosis of ulcerative colitis (UC) for at least 3 months prior to Baseline.\n * Active UC as assessed by adapted Mayo Score\n * Demonstrated intolerance or inadequate response to one or more biologic therapies\n * Females must be postmenopausal for more than 2 years or surgically sterile or practicing specific forms of birth control.\n\n","\n\n * Subject with a current diagnosis of Crohn's disease (CD), inflammatory bowel disease-unclassified (IBD-U) or a history of radiation colitis or ischemic colitis.\n * Subject receiving prohibited medications and treatment.\n * Extent of inflammatory disease limited to the rectum as assessed by screening endoscopy.\n * Subject with currently known complications of UC (e.g., megacolon).",{"$nulls":4},"Actual","2018-01-12","Actual","Anticipated","2022-08-29","Anticipated","2019-12-01","2018-01-08","2018-01-08","2019-12-19","Yes","ABBV-066\nBI 655066","Interventional","Treatment","Parallel Assignment","Double (Participant, Investigator)","Randomized","16 Years","80 Years","All",null,"No","Yes\nAbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2016-004677-40","EudraCT Number","Percentage of participants with clinical remission per adapted Mayo Score at Week 12","Clinical remission per adapted Mayo Score.","Week 12","Percentage of participants achieving clinical remission per full Mayo Score at Week 12 in subjects with a full Mayo score of 6 to 12 at Baseline|Ulcerative Colitis Symptom Questionnaire (UC-SQ): Change from Baseline to Week 12|Inflammatory Bowel Disease Questionnaire (IBDQ): Change from Baseline to Week 12|Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue): Change from Baseline to Week 12|Percentage of participants achieving clinical response per adapted Mayo Score at week 12|Percentage of participants with endoscopic remission at Week 12|Percentage of participants achieving clinical response per partial adapted Mayo Score at week 4|Percentage of participants with mucosal healing at Week 12|36-Item Short Form Health Status Survey (SF-36): Change from Baseline to Week 12|Percentage of participants with hospitalization through Week 12|Percentage of participants with Ulcerative Colitis (UC)-related surgeries through Week 12|Percentage of participants with endoscopic improvement at Week 12","Clinical remission per full Mayo Score.|The US-SQ is a patient questionnaire to assess severity of Crohn's symptoms.|The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.|The FACIT-Fatigue is a validated tool that measures an individual's level of fatigue during their usual daily activities over the past week.|Clinical response per adapted Mayo Score.|Endoscopic remission per endoscopy subscore.|Clinical response per partial adapted Mayo Score (without endoscopy).|Mucosal healing defined as endoscopic and histologic remission.|The SF-36 is an indicator of overall health status.|Participants with an event that results in admission to the hospital.|Participants who underwent surgery related to UC.|Endoscopic improvement per endoscopy subscore.","Week 12|Baseline, Week 12|Week 4|12 weeks","abbvieclinicaltrials@abbvie.com","ABBVIE CALL CENTER","847.283.8955",{"$cut":{"chars":22569,"head":"Buenos Aires, Argentina, 1431 Sanatorio 9 De Julio S.A. /Id# 167780San Miguel De Tucuman, Argentina, 4000|Rosario, Santa Fe, Argentina, 2000|Graz, Austria, 8036 Lkh Salzburg And Paracelsus /Id# 200685Salzburg, Austria, 5020|St. PÃ¶lten, Niederoesterreich, Austria, 3100|Linz, Oberoesterreich, Austria, 4010|Vienna, Wien, Austria, 1090|Brussels, Bruxelles-Capitale, Belgium, 1070 Cliniques Universitaires Saint Luc /Id# 200039Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200|Bonheiden, Belgium, 2820 Uz Brussels /Id# 164176Jette, Brussels, Belgium, 1090 Uz Leuven /Id# 170812Leuven, Belgium, 3000 Clinique St Joseph /Id# 200250Liege, Belgium, 4000 Az-Delta /Id# 200040Roeselare, Belgium, 8800 Chu Dinant Godinne - Ucl Namur /Id# 200254Yvoir, Belgium, 5530|Liege, Liege, Belgium, 4000|Gent, Oost-Vlaanderen, Belgium, 9000|Goiania, Goias, Brazil, 74535-170|Rio De Janeiro, Brazil, 21941-913|Curitiba, Parana, Brazil, 80810-040|Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903|Botucatu, Sao Paulo, Brazil, 18618-686 Hospital Das Clinicas Da Faculdade De Medicina De RibeirÃ£o Preto - Usp /Id# 157660RibeirÃ£o Preto, Sao Paulo, Brazil, 14048-900 Faculdade De Medicina Do Abc /Id# 163995Santo AndrÃ©, Sao Paulo, Brazil, 09060-870 Kaiser Clinica E Hospital Dia /Id# 157680Sao Jose Do Rio Preto, Sao Paulo, Brazil, 15015-110|Sliven, Bulgaria, 8800 Ii Mhat - Sofia /Id# 200799Sofia, Bulgaria, 1202 Umhat Tsaritsa Joanna - Isul /Id# 209977Sofia, Bulgaria, 1527 Umhat Sv. 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Rooseve /Id# 164347|Univ Medical Ctr Ljubljana /Id# 210627|, Free State Farmovs (Pty) Ltd /Id# 207537|, Western Cape Mediclinic Constantiaberg /Id# 171137|Dr Jp Wright /Id# 171138|Galicia Complejo Hospitalario Universitario De Ferrol /Id# 159440|Hospital Universitario Parc Tauli /Id# 159461|Pontevedra Hospital Alvaro Cunqueiro /Id# 167360|Su Molndal. /Id# 202843|Vastra Gotalands Lan AlingsÃ¥s Lasarett /Id# 202074|Zuerich University Hospital Zurich /Id# 202910|Ankara Univ Medical Faculty /Id# 167210|Istanbul Acibadem Kozyatagi Hospital /Id# 213276|Kayseri Erciyes University Medical Fac /Id# 171291|Kyivska Oblast Medical Centre Of Ok!Clinic Of International Institute Of Clinical Trials /Id# 205482|Regional Clinical Hospital /Id# 203367|, Devon Rd&E Hospital /Id# 157587|Barnsley Hospital Nhs Foundation Trust /Id# 202770|Southern California Res. Ctr. /Id# 169660|Peak Gastroenterology Associat /Id# 165841|Medical Research Ctr Ct /Id# 160311|South Lake Pain Institute, Inc /Id# 162878|Atlanta Gastro Assoc /Id# 160415|University Of Chicago /Id# 160521|Indiana University /Id# 167252|Cotton-O'Neil Clinical Res Ctr /Id# 160412|Houma Digestive Health Special /Id# 158317|Johns Hopkins University School Of Medicine /Id# 211793|Mgh Digestive Health Center /Id# 164255|University Of Michigan Hospitals /Id# 158524|Mayo Clinic - Rochester /Id# 200458|Quality Clinical Research Inc. /Id# 167313|Concorde Medical Group Pllc /Id# 211805|Carolinas Medical Center /Id# 158512|Plains Clinical Research Center, Llc /Id# 169732|Cleveland Clinic Main Campus /Id# 209232|Digestive Disease Specialists /Id# 170779|University Of Pennsylvania /Id# 166266|Gastroenterology Associates, P.A. /Id# 160472|Gastro One /Id# 160418|Inquest Clinical Research /Id# 165685|Advanced Research Institute /Id# 160480|Virginia Mason Medical Center /Id# 160466",{"$nulls":3},"AbbVie Inc.","2019-12-19","2020-05-25T16:36:38.072","2020-05-26T17:10:42.972","NCT03398148"]
["5ecbf416fe30261b1a048242","NCT03398148","2020-02-11","AbbVie","ABBV","Recruiting","A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy","Risankizumab","IL23 Inhibitor","No",null,"No",null,"Phase 2/Phase 3",16,720,"Anticipated","2018-03-07","2020-09-23",{"$nulls":5},"The objectives of Sub-Study 1 are to evaluate the efficacy, safety, and pharmacokinetics of risankizumab as induction treatment in subjects with moderately to severely active ulcerative colitis (UC), and to identify the appropriate induction dose of risankizumab for further evaluation in Sub-Study 2.\n\nThe objective of Sub-Study 2 is to evaluate the efficacy and safety of risankizumab compared to placebo in inducing clinical remission in subjects with moderately to severely active UC.",null,"A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy","M16-067","Ulcerative Colitis (UC)","Colitis|Colitis, Ulcerative","Gastrointestinal Diseases","Gastrointestinal","Experimental|Placebo Comparator","Substudy 1, Induction 2: Double-blind Risankizumab Dose 2|Substudy 2, Induction 1: Open-label Risankizumab Dose 2|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 2, Induction 2: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 2, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 3|Substudy 2, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 1, Induction 1: Open-label Risankizumab Dose 3","Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection in Induction 2.|Participants randomized to receive risankizumab dose 2 administered by intravenous (IV) infusion.|Participants who received placebo with inadequate response in Induction 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.|Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 3 administered by subcutaneous (SC) injection in Induction 2.|Participants randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion.|Participants who received placebo with inadequate response in Induction 1 receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.|Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.|Participants randomized to receive risankizumab dose 3 administered by intravenous (IV) infusion.|Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.|Participants receive risankizumab dose 3 administered by intravenous (IV) infusion.","Drug","risankizumab SC|risankizumab IV|placebo for risankizumab","risankizumab subcutaneous (SC) injection|risankizumab intravenous (IV) infusion|placebo for risankizumab","ABBV-066 | BI 655066","Substudy 1, Induction 2: Double-blind Risankizumab Dose 2|Substudy 2, Induction 1: Open-label Risankizumab Dose 2|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 2, Induction 2: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 2, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 3|Substudy 2, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 1, Induction 1: Open-label Risankizumab Dose 3","\n\n * Male or female aged >=18 to <= 80 years at the Baseline Visit. Where locally permissible, subjects 16 to < 18 years of age who meet the definition of Tanner stage 5 for development at the Baseline Visit\n * Confirmed diagnosis of ulcerative colitis (UC) for at least 3 months prior to Baseline.\n * Active UC as assessed by adapted Mayo Score\n * Demonstrated intolerance or inadequate response to one or more biologic therapies\n * Females must be postmenopausal for more than 2 years or surgically sterile or practicing specific forms of birth control.\n\n","\n\n * Subject with a current diagnosis of Crohn's disease (CD), inflammatory bowel disease-unclassified (IBD-U) or a history of radiation colitis or ischemic colitis.\n * Subject receiving prohibited medications and treatment.\n * Extent of inflammatory disease limited to the rectum as assessed by screening endoscopy.\n * Subject with currently known complications of UC (e.g., megacolon).",{"$nulls":4},"Actual","2018-01-12","Actual","Anticipated","2022-08-29","Anticipated","2020-02-01","2018-01-08","2018-01-08","2020-02-07","Yes","ABBV-066\nBI 655066","Interventional","Treatment","Parallel Assignment","Double (Participant, Investigator)","Randomized","16 Years","80 Years","All",null,"No","Yes\nAbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2016-004677-40","EudraCT Number","Percentage of participants with clinical remission per adapted Mayo Score at Week 12","Clinical remission per adapted Mayo Score.","Week 12","Percentage of participants achieving clinical remission per full Mayo Score at Week 12 in subjects with a full Mayo score of 6 to 12 at Baseline|Ulcerative Colitis Symptom Questionnaire (UC-SQ): Change from Baseline to Week 12|Inflammatory Bowel Disease Questionnaire (IBDQ): Change from Baseline to Week 12|Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue): Change from Baseline to Week 12|Percentage of participants achieving clinical response per adapted Mayo Score at week 12|Percentage of participants with endoscopic remission at Week 12|Percentage of participants achieving clinical response per partial adapted Mayo Score at week 4|Percentage of participants with mucosal healing at Week 12|36-Item Short Form Health Status Survey (SF-36): Change from Baseline to Week 12|Percentage of participants with hospitalization through Week 12|Percentage of participants with Ulcerative Colitis (UC)-related surgeries through Week 12|Percentage of participants with endoscopic improvement at Week 12","Clinical remission per full Mayo Score.|The US-SQ is a patient questionnaire to assess severity of Crohn's symptoms.|The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.|The FACIT-Fatigue is a validated tool that measures an individual's level of fatigue during their usual daily activities over the past week.|Clinical response per adapted Mayo Score.|Endoscopic remission per endoscopy subscore.|Clinical response per partial adapted Mayo Score (without endoscopy).|Mucosal healing defined as endoscopic and histologic remission.|The SF-36 is an indicator of overall health status.|Participants with an event that results in admission to the hospital.|Participants who underwent surgery related to UC.|Endoscopic improvement per endoscopy subscore.","Week 12|Baseline, Week 12|Week 4|12 weeks","abbvieclinicaltrials@abbvie.com","ABBVIE CALL CENTER","847.283.8955",{"$cut":{"chars":22456,"head":"Buenos Aires, Argentina, 1431 Sanatorio 9 De Julio S.A. /Id# 167780San Miguel De Tucuman, Argentina, 4000|Rosario, Santa Fe, Argentina, 2000|Graz, Austria, 8036 Lkh Salzburg And Paracelsus /Id# 200685Salzburg, Austria, 5020|St. PÃ¶lten, Niederoesterreich, Austria, 3100|Linz, Oberoesterreich, Austria, 4010|Vienna, Wien, Austria, 1090|Brussels, Bruxelles-Capitale, Belgium, 1070 Cliniques Universitaires Saint Luc /Id# 200039Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200|Bonheiden, Belgium, 2820 Uz Brussels /Id# 164176Jette, Brussels, Belgium, 1090 Uz Leuven /Id# 170812Leuven, Belgium, 3000 Clinique St Joseph /Id# 200250Liege, Belgium, 4000 Az-Delta /Id# 200040Roeselare, Belgium, 8800 Chu Dinant Godinne - Ucl Namur /Id# 200254Yvoir, Belgium, 5530|Liege, Liege, Belgium, 4000|Gent, Oost-Vlaanderen, Belgium, 9000|Goiania, Goias, Brazil, 74535-170|Rio De Janeiro, Brazil, 21941-913|Curitiba, Parana, Brazil, 80810-040|Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903|Botucatu, Sao Paulo, Brazil, 18618-686 Hospital Das Clinicas Da Faculdade De Medicina De RibeirÃ£o Preto - Usp /Id# 157660RibeirÃ£o Preto, Sao Paulo, Brazil, 14048-900 Faculdade De Medicina Do Abc /Id# 163995Santo AndrÃ©, Sao Paulo, Brazil, 09060-870 Kaiser Clinica E Hospital Dia /Id# 157680Sao Jose Do Rio Preto, Sao Paulo, Brazil, 15015-110|Sliven, Bulgaria, 8800 Ii Mhat - Sofia /Id# 200799Sofia, Bulgaria, 1202 Umhat Tsaritsa Joanna - Isul /Id# 209977Sofia, Bulgaria, 1527 Umhat Sv. 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Ctr. /Id# 169660|Peak Gastroenterology Associat /Id# 165841|Medical Research Ctr Ct /Id# 160311|South Lake Pain Institute, Inc /Id# 162878|Atlanta Gastro Assoc /Id# 160415|University Of Chicago /Id# 160521|Indiana University /Id# 167252|Cotton-O'Neil Clinical Res Ctr /Id# 160412|Houma Digestive Health Special /Id# 158317|Johns Hopkins University School Of Medicine /Id# 211793|Mgh Digestive Health Center /Id# 164255|University Of Michigan Hospitals /Id# 158524|Mayo Clinic - Rochester /Id# 200458|Quality Clinical Research Inc. /Id# 167313|Manhattan Clinical Research, Llc /Id# 211805|Carolinas Medical Center /Id# 158512|Plains Clinical Research Center, Llc /Id# 169732|Cleveland Clinic Main Campus /Id# 209232|Digestive Disease Specialists /Id# 170779|University Of Pennsylvania /Id# 166266|Gastroenterology Associates, P.A. /Id# 160472|Gastro One /Id# 160418|Inquest Clinical Research /Id# 165685|Advanced Research Institute /Id# 160480|Virginia Mason Medical Center /Id# 160466",{"$nulls":3},"AbbVie Inc.","2020-02-07","2020-05-25T16:36:38.209","2020-05-26T17:10:42.972","NCT03398148"]
["5ecbf416feab101b15530873","NCT03398148","2020-03-02","AbbVie","ABBV","Recruiting","A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy","Risankizumab","IL23 Inhibitor","No",null,"No",null,"Phase 2/Phase 3",16,1536,"Anticipated","2018-03-07","2020-09-23",{"$nulls":5},"The objectives of Sub-Study 1 are to evaluate the efficacy, safety, and pharmacokinetics of risankizumab as induction treatment in subjects with moderately to severely active ulcerative colitis (UC), and to identify the appropriate induction dose of risankizumab for further evaluation in Sub-Study 2.\n\nThe objective of Sub-Study 2 is to evaluate the efficacy and safety of risankizumab compared to placebo in inducing clinical remission in subjects with moderately to severely active UC.",null,"A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy","M16-067","Ulcerative Colitis (UC)","Colitis|Colitis, Ulcerative","Gastrointestinal Diseases","Gastrointestinal","Experimental|Placebo Comparator","Substudy 1, Induction 2: Double-blind Risankizumab Dose 2|Substudy 2, Induction 1: Open-label Risankizumab Dose 2|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 2, Induction 2: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 2, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 3|Substudy 2, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 1, Induction 1: Open-label Risankizumab Dose 3","Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection in Induction 2.|Participants randomized to receive risankizumab dose 2 administered by intravenous (IV) infusion.|Participants who received placebo with inadequate response in Induction 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.|Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 3 administered by subcutaneous (SC) injection in Induction 2.|Participants randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion.|Participants who received placebo with inadequate response in Induction 1 receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.|Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.|Participants randomized to receive risankizumab dose 3 administered by intravenous (IV) infusion.|Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.|Participants receive risankizumab dose 3 administered by intravenous (IV) infusion.","Drug","risankizumab SC|risankizumab IV|placebo for risankizumab","risankizumab subcutaneous (SC) injection|risankizumab intravenous (IV) infusion|placebo for risankizumab","ABBV-066 | BI 655066","Substudy 1, Induction 2: Double-blind Risankizumab Dose 2|Substudy 2, Induction 1: Open-label Risankizumab Dose 2|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 2, Induction 2: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 2, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 3|Substudy 2, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 1, Induction 1: Open-label Risankizumab Dose 3","\n\n * Male or female aged >=18 to <= 80 years at the Baseline Visit. Where locally permissible, subjects 16 to < 18 years of age who meet the definition of Tanner stage 5 for development at the Baseline Visit\n * Confirmed diagnosis of ulcerative colitis (UC) for at least 3 months prior to Baseline.\n * Active UC as assessed by adapted Mayo Score\n * Demonstrated intolerance or inadequate response to one or more biologic therapies\n * Females must be postmenopausal for more than 2 years or surgically sterile or practicing specific forms of birth control.\n\n","\n\n * Subject with a current diagnosis of Crohn's disease (CD), inflammatory bowel disease-unclassified (IBD-U) or a history of radiation colitis or ischemic colitis.\n * Subject receiving prohibited medications and treatment.\n * Extent of inflammatory disease limited to the rectum as assessed by screening endoscopy.\n * Subject with currently known complications of UC (e.g., megacolon).",{"$nulls":4},"Actual","2018-01-12","Actual","Anticipated","2022-06-01","Anticipated","2020-02-01","2018-01-08","2018-01-08","2020-02-28","Yes","ABBV-066\nBI 655066","Interventional","Treatment","Parallel Assignment","Double (Participant, Investigator)","Randomized","16 Years","80 Years","All",null,"No","Yes\nAbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2016-004677-40","EudraCT Number","Percentage of participants with clinical remission per adapted Mayo Score at Week 12","Clinical remission per adapted Mayo Score.","Week 12","Percentage of participants achieving clinical remission per full Mayo Score at Week 12 in subjects with a full Mayo score of 6 to 12 at Baseline|Ulcerative Colitis Symptom Questionnaire (UC-SQ): Change from Baseline to Week 12|Inflammatory Bowel Disease Questionnaire (IBDQ): Change from Baseline to Week 12|Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue): Change from Baseline to Week 12|Percentage of participants achieving clinical response per adapted Mayo Score at week 12|Percentage of participants with endoscopic remission at Week 12|Percentage of participants achieving clinical response per partial adapted Mayo Score at week 4|Percentage of participants with mucosal healing at Week 12|36-Item Short Form Health Status Survey (SF-36): Change from Baseline to Week 12|Percentage of participants with hospitalization through Week 12|Percentage of participants with Ulcerative Colitis (UC)-related surgeries through Week 12|Percentage of participants with endoscopic improvement at Week 12","Clinical remission per full Mayo Score.|The US-SQ is a patient questionnaire to assess severity of Crohn's symptoms.|The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.|The FACIT-Fatigue is a validated tool that measures an individual's level of fatigue during their usual daily activities over the past week.|Clinical response per adapted Mayo Score.|Endoscopic remission per endoscopy subscore.|Clinical response per partial adapted Mayo Score (without endoscopy).|Mucosal healing defined as endoscopic and histologic remission.|The SF-36 is an indicator of overall health status.|Participants with an event that results in admission to the hospital.|Participants who underwent surgery related to UC.|Endoscopic improvement per endoscopy subscore.","Week 12|Baseline, Week 12|Week 4|12 weeks","abbvieclinicaltrials@abbvie.com","ABBVIE CALL CENTER","847.283.8955",{"$cut":{"chars":22455,"head":"Buenos Aires, Argentina, 1431 Sanatorio 9 De Julio S.A. /Id# 167780San Miguel De Tucuman, Argentina, 4000|Rosario, Santa Fe, Argentina, 2000|Graz, Austria, 8036 Lkh Salzburg And Paracelsus /Id# 200685Salzburg, Austria, 5020|St. PÃ¶lten, Niederoesterreich, Austria, 3100|Linz, Oberoesterreich, Austria, 4010|Vienna, Wien, Austria, 1090|Brussels, Bruxelles-Capitale, Belgium, 1070 Cliniques Universitaires Saint Luc /Id# 200039Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200|Bonheiden, Belgium, 2820 Uz Brussels /Id# 164176Jette, Brussels, Belgium, 1090 Uz Leuven /Id# 170812Leuven, Belgium, 3000 Clinique St Joseph /Id# 200250Liege, Belgium, 4000 Az-Delta /Id# 200040Roeselare, Belgium, 8800 Chu Dinant Godinne - Ucl Namur /Id# 200254Yvoir, Belgium, 5530|Liege, Liege, Belgium, 4000|Gent, Oost-Vlaanderen, Belgium, 9000|Goiania, Goias, Brazil, 74535-170|Rio De Janeiro, Brazil, 21941-913|Curitiba, Parana, Brazil, 80810-040|Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903|Botucatu, Sao Paulo, Brazil, 18618-686 Hospital Das Clinicas Da Faculdade De Medicina De RibeirÃ£o Preto - Usp /Id# 157660RibeirÃ£o Preto, Sao Paulo, Brazil, 14048-900 Faculdade De Medicina Do Abc /Id# 163995Santo AndrÃ©, Sao Paulo, Brazil, 09060-870 Kaiser Clinica E Hospital Dia /Id# 157680Sao Jose Do Rio Preto, Sao Paulo, Brazil, 15015-110|Sliven, Bulgaria, 8800 Ii Mhat - Sofia /Id# 200799Sofia, Bulgaria, 1202 Umhat Tsaritsa Joanna - Isul /Id# 209977Sofia, Bulgaria, 1527 Umhat Sv. 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Ctr. /Id# 169660|Peak Gastroenterology Associat /Id# 165841|Medical Research Ctr Ct /Id# 160311|South Lake Pain Institute, Inc /Id# 162878|Atlanta Gastro Assoc /Id# 160415|University Of Chicago /Id# 160521|Indiana University /Id# 167252|Cotton-O'Neil Clinical Res Ctr /Id# 160412|Houma Digestive Health Special /Id# 158317|Johns Hopkins University School Of Medicine /Id# 211793|Mgh Digestive Health Center /Id# 164255|University Of Michigan Hospitals /Id# 158524|Mayo Clinic - Rochester /Id# 200458|Quality Clinical Research Inc. /Id# 167313|Manhattan Clinical Research, Llc /Id# 211805|Carolinas Medical Center /Id# 158512|Plains Clinical Research Center, Llc /Id# 169732|Cleveland Clinic Main Campus /Id# 209232|Digestive Disease Specialists /Id# 170779|University Of Pennsylvania /Id# 166266|Gastroenterology Associates, P.A. /Id# 160472|Gastro One /Id# 160418|Inquest Clinical Research /Id# 165685|Advanced Research Institute /Id# 160480|Virginia Mason Medical Center /Id# 160466",{"$nulls":3},"AbbVie Inc.","2020-02-28","2020-05-25T16:36:38.518","2020-05-26T17:10:42.972","NCT03398148"]
["5ecbf41611702c1b1b916a54","NCT03398148","2020-05-01","AbbVie","ABBV","Recruiting","A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy","Risankizumab","IL23 Inhibitor","No",null,"No",null,"Phase 2/Phase 3",16,1536,"Anticipated","2018-03-07","2020-09-23",{"$nulls":5},"The objectives of Sub-Study 1 are to evaluate the efficacy, safety, and pharmacokinetics of risankizumab as induction treatment in subjects with moderately to severely active ulcerative colitis (UC), and to identify the appropriate induction dose of risankizumab for further evaluation in Sub-Study 2.\n\nThe objective of Sub-Study 2 is to evaluate the efficacy and safety of risankizumab compared to placebo in inducing clinical remission in subjects with moderately to severely active UC.",null,"A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy","M16-067","Ulcerative Colitis (UC)","Colitis|Colitis, Ulcerative","Gastrointestinal Diseases","Gastrointestinal","Experimental|Placebo Comparator","Substudy 1, Induction 2: Double-blind Risankizumab Dose 2|Substudy 2, Induction 1: Open-label Risankizumab Dose 2|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 2, Induction 2: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 2, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 3|Substudy 2, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 1, Induction 1: Open-label Risankizumab Dose 3","Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection in Induction 2.|Participants randomized to receive risankizumab dose 2 administered by intravenous (IV) infusion.|Participants who received placebo with inadequate response in Induction 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.|Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 3 administered by subcutaneous (SC) injection in Induction 2.|Participants randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion.|Participants who received placebo with inadequate response in Induction 1 receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.|Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.|Participants randomized to receive risankizumab dose 3 administered by intravenous (IV) infusion.|Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.|Participants receive risankizumab dose 3 administered by intravenous (IV) infusion.","Drug","risankizumab SC|risankizumab IV|placebo for risankizumab","risankizumab subcutaneous (SC) injection|risankizumab intravenous (IV) infusion|placebo for risankizumab","ABBV-066 | BI 655066","Substudy 1, Induction 2: Double-blind Risankizumab Dose 2|Substudy 2, Induction 1: Open-label Risankizumab Dose 2|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 2, Induction 2: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(a)|Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 2, Induction 1: Double-blind Risankizumab Dose 1|Substudy 1, Induction 1: Double-blind Risankizumab Dose 3|Substudy 1, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 2|Substudy 1, Induction 2: Double-blind Risankizumab Dose 3|Substudy 2, Induction 1: Double-blind Placebo|Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(b)|Substudy 1, Induction 1: Open-label Risankizumab Dose 3","\n\n * Male or female aged >=18 to <= 80 years at the Baseline Visit. Where locally permissible, subjects 16 to < 18 years of age who meet the definition of Tanner stage 5 for development at the Baseline Visit\n * Confirmed diagnosis of ulcerative colitis (UC) for at least 3 months prior to Baseline.\n * Active UC as assessed by adapted Mayo Score\n * Demonstrated intolerance or inadequate response to one or more biologic therapies\n * Females must be postmenopausal for more than 2 years or surgically sterile or practicing specific forms of birth control.\n\n","\n\n * Subject with a current diagnosis of Crohn's disease (CD), inflammatory bowel disease-unclassified (IBD-U) or a history of radiation colitis or ischemic colitis.\n * Subject receiving prohibited medications and treatment.\n * Extent of inflammatory disease limited to the rectum as assessed by screening endoscopy.\n * Subject with currently known complications of UC (e.g., megacolon).",{"$nulls":4},"Actual","2018-01-12","Actual","Anticipated","2022-06-01","Anticipated","2020-04-01","2018-01-08","2018-01-08","2020-04-30","Yes","ABBV-066\nBI 655066","Interventional","Treatment","Parallel Assignment","Double (Participant, Investigator)","Randomized","16 Years","80 Years","All",null,"No","Yes\nAbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2016-004677-40","EudraCT Number","Percentage of participants with clinical remission per adapted Mayo Score at Week 12","Clinical remission per adapted Mayo Score.","Week 12","Percentage of participants achieving clinical remission per full Mayo Score at Week 12 in subjects with a full Mayo score of 6 to 12 at Baseline|Ulcerative Colitis Symptom Questionnaire (UC-SQ): Change from Baseline to Week 12|Inflammatory Bowel Disease Questionnaire (IBDQ): Change from Baseline to Week 12|Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue): Change from Baseline to Week 12|Percentage of participants achieving clinical response per adapted Mayo Score at week 12|Percentage of participants with endoscopic remission at Week 12|Percentage of participants achieving clinical response per partial adapted Mayo Score at week 4|Percentage of participants with mucosal healing at Week 12|36-Item Short Form Health Status Survey (SF-36): Change from Baseline to Week 12|Percentage of participants with hospitalization through Week 12|Percentage of participants with Ulcerative Colitis (UC)-related surgeries through Week 12|Percentage of participants with endoscopic improvement at Week 12","Clinical remission per full Mayo Score.|The US-SQ is a patient questionnaire to assess severity of Crohn's symptoms.|The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.|The FACIT-Fatigue is a validated tool that measures an individual's level of fatigue during their usual daily activities over the past week.|Clinical response per adapted Mayo Score.|Endoscopic remission per endoscopy subscore.|Clinical response per partial adapted Mayo Score (without endoscopy).|Mucosal healing defined as endoscopic and histologic remission.|The SF-36 is an indicator of overall health status.|Participants with an event that results in admission to the hospital.|Participants who underwent surgery related to UC.|Endoscopic improvement per endoscopy subscore.","Week 12|Baseline, Week 12|Week 4|12 weeks","abbvieclinicaltrials@abbvie.com","ABBVIE CALL CENTER","847.283.8955",{"$cut":{"chars":22443,"head":"Buenos Aires, Argentina, 1431 Sanatorio 9 De Julio S.A. /Id# 167780San Miguel De Tucuman, Argentina, 4000|Rosario, Santa Fe, Argentina, 2000|Graz, Austria, 8036 Lkh Salzburg And Paracelsus /Id# 200685Salzburg, Austria, 5020|St. PÃ¶lten, Niederoesterreich, Austria, 3100|Linz, Oberoesterreich, Austria, 4010|Vienna, Wien, Austria, 1090|Brussels, Bruxelles-Capitale, Belgium, 1070 Cliniques Universitaires Saint Luc /Id# 200039Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200|Bonheiden, Belgium, 2820 Uz Brussels /Id# 164176Jette, Brussels, Belgium, 1090 Uz Leuven /Id# 170812Leuven, Belgium, 3000 Chu De Liege /Id# 200253Liege, Belgium, 4000 Groupe Sante Chc - Clinique Du Montlegia /Id# 200250Liege, Belgium, 4000 Az-Delta /Id# 200040Roeselare, Belgium, 8800 Chu Dinant Godinne - Ucl Namur /Id# 200254Yvoir, Belgium, 5530|Gent, Oost-Vlaanderen, Belgium, 9000|Goiania, Goias, Brazil, 74535-170|Rio De Janeiro, Brazil, 21941-913|Curitiba, Parana, Brazil, 80810-040|Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903|Botucatu, Sao Paulo, Brazil, 18618-686 Hospital Das Clinicas Da Faculdade De Medicina De RibeirÃ£o Preto - Usp /Id# 157660RibeirÃ£o Preto, Sao Paulo, Brazil, 14048-900 Faculdade De Medicina Do Abc /Id# 163995Santo AndrÃ©, Sao Paulo, Brazil, 09060-870 Kaiser Clinica E Hospital Dia /Id# 157680Sao Jose Do Rio Preto, Sao Paulo, Brazil, 15015-110|Sliven, Bulgaria, 8800 Ii Mhat - Sofia /Id# 200799Sofia, Bulgaria, 1202 Umhat Tsaritsa Joanna - Isul /Id# 209977Sofia, Bulgaria, 1527 Umhat Sv. 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Klinikum Graz /Id# 169053|Niederoesterreich UniversitÃ¤tsklinikum St.PÃ¶lten /Id# 169048|Oberoesterreich Ordensklinikum Linz Gmbh, Barmherzige Schwestern /Id# 215320|Wien Medical University Of Vienna /Id# 169050|Bruxelles-Capitale Cub Hospital Erasme /Id# 200252|Imelda Ziekenhuis /Id# 211100|Oost-Vlaanderen Uz Gent /Id# 200251|Goias Instituto Goiano De Gastroenterologia E Endoscopia Digestiva Ltda /Id# 157679|Hosp U Clementino Fraga Filho /Id# 157661|Parana Hospital Nossa Senhora Das GraÃ§as /Id# 157671|Rio Grande Do Sul Hospital De Clinicas De Porto Alegre /Id# 157662|Sao Paulo Upeclin Fmb - Unesp /Id# 157690|Mbal Hadzhi Dimitar /Id# 207945|Alberta University Of Calgary /Id# 169111|British Columbia Fraser Clinical Trials Inc /Id# 169102|Nova Scotia Iwk Health Center /Id# 169110|Ontario London Health Sciences Centre /Id# 169103|Quebec Hopital Hotel-Dieu De Levis /Id# 214378|Araucania Servicio De Salud AraucanÃ­a Norte Hospital Victoria /Id# 213151|Hospital Guillermo Grant Benavente De ConcepciÃ³n /Id# 210761|Region Metropolitana De Santiago Complejo Asistencial Dr. Sotero Del Rio /Id# 169385|Anhui The First Affiliated Hospital Of Anhui Medical University /Id# 211228|Beijing Friendship Hospital /Id# 211066|Guangdong The Sixty Affiliated Hospital Of Sun Yat-Sen University /Id# 211231|Hebei The Second Hospital Of Hebei Medical University /Id# 213018|Hospital /Id# 211276|Hunan Xiangya Hospital Central South University /Id# 211197|Jiangsu Wuxi People's Hospital /Id# 218798|Jiangxi 1St Aff Hosp Nanchang Univ /Id# 212183|Jilin The First Hosp Of Jilin Univ /Id# 212278|Medical University /Id# 211646|Ningxia General Hospital Of Ningxia Medical University /Id# 213911|Shaanxi Xijing Hospital /Id# 211639|Shanghai Ruijin Hospital, Shanghai Jiaotong /Id# 210962|Zhejiang The Second Affiliated Hospital Of Zhejiang University School Of Medicine /Id# 211025|Cundinamarca Corporacion Hospitalaria Juan Ciudad Sede Denominada Hospital Universitario Mayo /Id# 158717|Hospital Universitario San Vic /Id# 171490|Grad Zagreb Klinicka Bolnica Dubrava Zagreb /Id# 157475|Klinicki Bolnicki Centar Split /Id# 157473|Osjecko-Baranjska Zupanija Klinicki Bolnicki Centar Osijek /Id# 157472|Hovedstaden Bispebjerg Hospital /Id# 208945|Hvidovre Hospital /Id# 202266|SjÃ¦lland Sjaellands Universitets Hospit /Id# 200033|Syddanmark Odense Universitets Hospital /Id# 205602|Clinical Research Center, Faculty Of Medicine, Alexandria University. /Id# 200848|Alpes-Maritimes Chu De Nice-Hopital L'Archet Ii /Id# 171577|Chu Amiens Picardie - Site Sud /Id# 171576|Gironde HÃ´pital Haut-LÃ©vÃªque /Id# 171579|Hopital Beaujon /Id# 200092|Loire Chu De Saint Etienne - Hopital Nord /Id# 171580|Baden-Wuerttemberg Universitatsklinikum Mannheim /Id# 162035|Bayern Universitaetsklinikum Erlangen /Id# 159354|Nordrhein-Westfalen Uniklinik Koln /Id# 164991|Praxis Am Bayrischen Platz /Id# 159361|Schleswig-Holstein Univ Hosp Schleswig-Holstein /Id# 159360|Thueringen Universitaetsklinikum Ulm /Id# 164992|Attiki General Hospital Of Athens Laiko /Id# 206440|General Hospital Of Chest Diseases Of Athens Sotiria /Id# 170915|Hadarom Soroka Medical Center /Id# 171100|Rambam Medical Center /Id# 171101|Tel-Aviv Rabin Medical Center /Id# 167403|Yerushalayim Hadassah Ein Kerem Medical Ctr /Id# 171099|Calabria Universita Di Catanzaro Magna Graecia /Id# 200125|Emilia-Romagna Ospedale Sant Orsola Malpighi /Id# 155611|Lazio Policlinico Universitario Campus Bio-Medico /Id# 163992|Lombardia Asst Rhodense /Id# 211449|Milano Istituto Clinico Humanitas /Id# 155610|Ospedale Policlinico San Martino - Irccs /Id# 164031|Sicilia A.O. Per L'Emergenza Cannizzaro /Id# 164036|Verona Ospedale Classificato Equiparato Sacro Cuore-Don Calabria /Id# 164041|Aichi Aichi Medical University Hosp /Id# 164332|Chiba Toho University Sakura Medical Center /Id# 164254|Fukuoka Fukuoka University Chikushi Hospital /Id# 209055|Gifu Gifu University Hospital /Id# 208081|Gunma National Hospital Organization Takasaki General Medical Center /Id# 164437|Hiroshima Nho Fukuyama Medical Center /Id# 164439|Hiroshima University Hospital /Id# 164426|Hokkaido Asahikawa Medical University Hospital /Id# 164433|Hyogo Aoyama Clinic /Id# 164425|Ishikawa Kanazawa University Ho /Id# 169224|Kanagawa Gokeikai Ofuna Chuo Hospital /Id# 169300|Mie Mie University Hospital /Id# 203633|Miyagi Tohoku University Hospital /Id# 164430|Nagasaki Nagasaki University Hospital /Id# 202674|Saga Saga University Hospital /Id# 209396|Saitama Tokito Clinic /Id# 164253|Shiga Shiga University Of Medical Science Hospital /Id# 164440|Tokyo Medical Hospital Of Tokyo Medical And Dental University /Id# 164258|Yamagata Yamagata University Hospital /Id# 171474|Riga East Clinical Univ Hosp /Id# 163802|Kaunas Hospital Of Lithuanian Univers /Id# 170714|Vilnius University Hospital /Id# 170614|Selangor Ukm Medical Centre /Id# 200635|Health Pharma Professional Research S.A De C.V /Id# 203597|Morelos Jm Research Sc /Id# 203593|Elisabeth Tweesteden Ziekenhuis /Id# 163767|Noord-Holland Academisch Medisch Centrum /Id# 157959|, Bay Of Plenty Tauranga Hospital /Id# 212792|, Canterbury Christchurch Hospital /Id# 205342|, Waikato Waikato Hospital /Id# 212789|Hutt Valley Dist Health Board /Id# 212786|Dolnoslaskie Vistamed /Id# 210105|Malopolskie Centrum Medyczne Plejady /Id# 170633|Mazowieckie Centrum Zdrowia Mdm /Id# 170597|Nzoz Vitamed /Id# 213283|Slaskie Nzoz All-Medicus /Id# 170596|Zachodniopomorskie Endoskopia Sp. Z O.O. /Id# 170598|Centro Hospitalar E UniversitÃ¡rio De Coimbra, Epe /Id# 166054|Faro Centro Hospitalar Do Algarve - Hospital De PortimÃ£o /Id# 166551|Lisboa Centro Hosp De Lisboa Central /Id# 165582|Setubal Hospital Garcia De Orta, E.P.E /Id# 165583|Institutul Clinic Fundeni /Id# 171264|/Id# 200152|Sumadijski Okrug Clinical Center Kragujevac /Id# 156913|Fn S Poliklinikou F.D. Rooseve /Id# 164347|Univ Medical Ctr Ljubljana /Id# 210627|, Free State Farmovs (Pty) Ltd /Id# 207537|, Western Cape Mediclinic Constantiaberg /Id# 171137|Dr Jp Wright /Id# 171138|Galicia Complejo Hospitalario Universitario De Ferrol /Id# 159440|Hospital Universitario Parc Tauli /Id# 159461|Pontevedra Hospital Alvaro Cunqueiro /Id# 167360|Su Molndal. /Id# 202843|Vastra Gotalands Lan AlingsÃ¥s Lasarett /Id# 202074|Zuerich University Hospital Zurich /Id# 202910|Ankara Univ Medical Faculty /Id# 167210|Istanbul Acibadem Kozyatagi Hospital /Id# 213276|Kayseri Erciyes University Medical Fac /Id# 171291|Kyivska Oblast Medical Centre Ok Clinic Of International Institute Of Clinical Research Llc /Id# 205482|Regional Clinical Hospital /Id# 203367|, Devon Rd&E Hospital /Id# 157587|Barnsley Hospital Nhs Foundation Trust /Id# 202770|Southern California Res. Ctr. /Id# 169660|Peak Gastroenterology Associat /Id# 165841|Medical Research Ctr Ct /Id# 160311|South Lake Pain Institute, Inc /Id# 162878|Gastro Assoc Of Central Ga /Id# 160523|University Of Chicago /Id# 160521|Indiana University /Id# 167252|Cotton-O'Neil Clinical Res Ctr /Id# 160412|Robely Rex Va Medical Center /Id# 218648|Houma Digestive Health Special /Id# 158317|Johns Hopkins University School Of Medicine /Id# 211793|Mgh Digestive Health Center /Id# 164255|University Of Michigan Hospitals /Id# 158524|Mayo Clinic - Rochester /Id# 200458|Quality Clinical Research Inc. /Id# 167313|Manhattan Clinical Research, Llc /Id# 211805|Atrium Health Carolinas Medical Center /Id# 158512|Plains Clinical Research Center, Llc /Id# 169732|Cleveland Clinic Main Campus /Id# 209232|Digestive Disease Specialists /Id# 170779|University Of Pennsylvania /Id# 166266|Gastroenterology Associates, P.A. /Id# 160472|Gastro One /Id# 160418|Inquest Clinical Research /Id# 165685|Advanced Research Institute /Id# 160480|Virginia Mason Medical Center /Id# 160466",{"$nulls":3},"AbbVie Inc.","2020-04-30","2020-05-25T16:36:38.713","2020-05-26T17:10:42.972","NCT03398148"]
["5ecbf417307e3d1b1f8d9cd5","NCT03398421","2018-01-12","GlaxoSmithKline","GSK","Not yet recruiting","A Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics (PK) of Nemiralisib","Nemiralisib|Itraconazole","PI3K Inhibitor|CYP3A4 Inhibitor","Yes","['Nemiralisib']","No",null,"Phase 1",1,20,"Anticipated","2018-01-17","2018-03-13","AUC","Area Under The Curve",{"$nulls":3},"Nemiralisib is a potent anti-inflammatory agent for the treatment of chronic obstructive pulmonary disease (COPD) and other inflammatory lung diseases. The Cytochrome P450 3A4 (CYP3A4) is a major route of clearance for nemiralisib. The co-administration of drug therapies, which modulate CYP3A4, may alter the exposure of nemiralisib. Hence, this clinical drug interaction study with itraconazole (a potent CYP3A4 inhibitor) is required. The study will evaluate the PK, safety and tolerability of nemiralisib when administered alone and when administered concomitantly with repeat doses of itraconazole in healthy males and females. Subjects will receive treatment with nemiralisib alone in Period 1 and itraconazole followed by nemiralisib in Period 2 in single sequence crossover manner. Approximately 20 subjects will be enrolled such that approximately 16 evaluable subjects complete the study. Each subject will participate in the study for approximately 7 weeks including screening visit, 2 treatment periods and a follow up visit.",null,"A Single Centre, Open Label, One Sequence, Cross-over Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics of Single Inhaled Doses of Nemiralisib in Healthy Subjects",206874,"Pulmonary Disease, Chronic Obstructive","Chronic Obstructive Pulmonary Disease","Lung Diseases","Respiratory","Experimental","Subjects receiving nemiralisib and itraconazole","Eligible subjects will receive a single dose of 100 micrograms (mcg) nemiralisib on Day 1 in Period 1. Subjects will also receive a single dose of 200 milligrams (mg) itraconazole in the morning from Day 1 to Day 10 and single dose of 100 mcg nemiralisib on Day 5, one hour after the dose of itraconazole in Period 2. There will be a washout of at least 14 days between the administration of nemiralisib in Period 1 and Period 2.","Drug","Nemiralisib|Itraconazole","Nemiralisib will be given as 100 mcg via ELLIPTA Dry Powder Inhaler with 30 doses per inhaler/ 100 mcg total dose. ELLIPTAÂ® is a registered trademark of GlaxoSmithKline group of companies.|Itraconazole will be given as 100 mg per capsule per day administered orally with water",null,"Subjects receiving nemiralisib and itraconazole","\n\n * Subjects must be 18 to 75 years of age inclusive, at the time of signing the informed consent.\n * Subjects who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac evaluation.\n * Normal spirometry at Screening (FEV1 and forced vital capacity [FVC] >=80 percent of predicted. Measurements to be taken in triplicate. The highest value of each individual component must be >=80 percent of predicted).\n * A subject with a clinical abnormality or laboratory parameter(s) (except for liver function tests) outside the reference range for the population being studied may be included only if the investigator, in consultation with the medical monitor if needed, agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.\n * Body weight >50 kilograms (kg) and body mass index (BMI) within the range 18.0-35.0 kg per meter square (kg/m^2) (inclusive).\n * Male and/or female: A male subject must agree to use contraception during the treatment period and for at least 10 days after the last dose of study treatment and refrain from donating sperm during this period; a female subject is eligible to participate if she is not pregnant, not breastfeeding, and not a woman of childbearing potential (WOCBP).\n * Capable of giving signed informed consent.\n\n","\n\n * History or presence of cardiovascular, respiratory (except childhood asthma, which has now remitted), hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study treatment; or interfering with the interpretation of data.\n * Abnormal blood pressure.\n * Liver function test results above the upper limit of normal (ULN).\n * Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).\n * QT interval corrected for heart rate by Fridericia's formula (QTcF) >450 milliseconds (msec).\n * Past or intended use of over-the-counter or prescription medication including herbal medications within 14 days prior to dosing.\n * Participation in the study would result in loss of blood or blood products in excess of 500 milliliter (mL) within 90 days.\n * Exposure to more than 4 new chemical entities within 12 months prior to the first dosing day.\n * Current enrolment or past participation within the last 30 days before signing of consent in this or any other clinical study involving an investigational study treatment or any other type of medical research.\n * Presence of Hepatitis B surface antigen (HBsAg) at screening or positive Hepatitis C antibody test result at screening.\n * Positive Hepatitis C ribonucleic acid (RNA) test result at screening or within 3 months prior to first dose of study treatment.\n * Positive human immunodeficiency virus (HIV) antibody test (according to local policies).\n * Positive drug/alcohol test at screening or on admission (Day -1).\n * Regular use of known drugs of abuse.\n * Regular alcohol consumption within 6 months prior to the study defined as: an average weekly intake of >14 drinks for males or >7 drinks for females. One drink is equivalent to 12 grams (g) of alcohol: 12 ounces (360 mL) of beer, 5 ounces (150 mL) of wine or 1.5 ounces (45 mL) of 80 proof distilled spirits.\n * Urinary cotinine levels indicative of smoking or history of regular use of tobacco- or nicotine-containing products within 6 months of screening, or a total pack year history of >5 pack years. [number of pack years = (number of cigarettes per day/20) x number of years smoked].\n * Sensitivity to any of the study treatments, or components thereof (including lactose and Magnesium Stearate), or drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the study.\n * Unwillingness to follow the lifestyle restrictions.",{"$nulls":4},"Actual","2018-01-12","Actual","Anticipated","2018-03-13","Anticipated","2018-01-01","2018-01-08","2018-01-08","2018-01-08",null,"Nemiralisib\nPharmacokinetics\nItraconazole\nDrug-drug Interaction\nCross-over","Interventional","Treatment","Crossover Assignment","None (Open Label)","Non-Randomized","18 Years","75 Years","All",null,"Yes","Yes\nIPD for this study will be made available via the Clinical Study Data Request site.",{"$nulls":3},"Yes","No",{"$nulls":19},"Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUC [0-infinity]) of nemiralisib following administration of itraconazole in Period 2|Area under the plasma concentration versus time curve from time zero to t (AUC [0-t]) of nemiralisib following administration of itraconazole in Period 2|Maximum observed plasma concentration (Cmax) of nemiralisib following administration of itraconazole in Period 2|Time to Cmax (Tmax) of nemiralisib following administration of itraconazole in Period 2|Terminal phase half-life (T1/2) of nemiralisib following administration of itraconazole in Period 2","Blood samples will be collected for pharmacokinetic analysis of nemiralisib following repeat doses of itraconazole.|Blood samples will be collected for pharmacokinetic analysis of nemiralisib following repeat doses of itraconazole","Pre-dose, and 5, 30 minutes, 2 , 6, 12, 24, 48, 72, 96, 120 and 144 hours post-dose","Number of subjects with adverse events (AEs)|Number of subjects with serious AEs (SAEs)|Number of subjects with abnormal clinical chemistry laboratory parameters|Number of subjects with abnormal hematology laboratory parameters|Number of subjects with abnormal values for urinalysis|Number of subjects with abnormal values for blood pressure|Number of subjects with abnormal values for body temperature|Number of subjects with abnormal pulse rate|Number of subjects with abnormal respiratory rate|Number of subjects with abnormal electrocardiogram (ECG) findings|Forced expiratory volume in 1 second (FEV1) following doing with nemiralisib when dosed alone and concomitantly with itraconazole|AUC (0-infinity) of itraconazole when co-administered with nemiralisib in Period 2|AUC (0-infinity) of hydroxy-itraconazole when co-administered with nemiralisib in Period 2|AUC (0-t) of itraconazole when co-administered with nemiralisib in Period 2|AUC (0-t) of hydroxy-itraconazole when co-administered with nemiralisib in Period 2|Cmax of itraconazole when co-administered with nemiralisib in Period 2|Cmax of hydroxy-itraconazole when co-administered with nemiralisib in Period 2|Tmax of itraconazole when co-administered with nemiralisib in Period 2|Tmax of hydroxy-itraconazole when co-administered with nemiralisib in Period 2|T1/2 of itraconazole when co-administered with nemiralisib in Period 2|T1/2 of hydroxy-itraconazole when co-administered with nemiralisib in Period 2","An AE is any untoward medical occurrence in a clinical study subject, temporally associated with the use of a study treatment, whether or not considered related to the study treatment.|Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment will be categorized as SAE.|Clinical chemistry parameters will be analyzed as a measure of safety including blood urea nitrogen (BUN), potassium, aspartate aminotransferase (AST)/Serum Glutamic-Oxaloacetic Transaminase (SGOT), total and direct bilirubin, creatinine, sodium, alanine aminotransferase (ALT)/Serum Glutamic-Pyruvic Transaminase (SGPT), total protein, glucose, calcium and alkaline phosphatase.|Hematology parameters will be analyzed as a measure of safety including platelet count, red blood cell (RBC) count, hemoglobin, hematocrit, mean corpuscular volume, mean corpuscular hemoglobin, percent reticulocytes, neutrophils, lymphocytes, monocytes, eosinophils and basophils.|Urinalysis parameters will be analyzed including specific gravity. The dipstick method will be used to analyze potential of hydrogen (pH), glucose, protein, blood, ketones, bilirubin, urobilinogen, nitrite, leukocyte esterase. Microscopic examination will be performed if blood or protein is abnormal.|Systolic and diastolic blood pressure will be measured in a supine or semi-supine position after 5 minutes rest.|Body temperature will be measured in a supine or semi-supine position after at least a 5 minutes rest.|Pulse rate will be measured in a supine or semi-supine position after 5 minutes rest.|Respiratory rate will be measured in a supine or semi-supine position after at least a 5 minutes rest.|A 12-lead ECGs will be measured in a supine or semi-supine position after 5 minutes rest at each time point using ECG machine.|FEV1 is defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 is a measure of lung function which will be assessed by spirometry.|Blood samples will be collected for pharmacokinetic analysis of itraconazole when co-administered with nemiralisib.|Blood samples will be collected for pharmacokinetic analysis of hydroxy-itraconazole when co-administered with nemiralisib.","Up to 41 days|Screening and up to 41 days|Up to 30 days|Up to Day 4|Pre-dose, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose on Day 1 and Day 5; 24 hours post-dose on Day 5","GSKClinicalSupportHD@gsk.com","US GSK Clinical Trials Call Center","877-379-3718",{"$nulls":7},"GSK Clinical Trials","2018-01-08","2020-05-25T16:36:39.539","2020-05-26T17:10:42.972","NCT03398421"]
["5ecbf417307e3d1b1f8d9cd6","NCT03398421","2018-02-12","GlaxoSmithKline","GSK","Active, not recruiting","A Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics (PK) of Nemiralisib","Nemiralisib|Itraconazole","PI3K Inhibitor|CYP3A4 Inhibitor","Yes","['Nemiralisib']","No",null,"Phase 1",1,20,"Anticipated","2018-01-17","2018-03-13","AUC","Area Under The Curve",{"$nulls":3},"Nemiralisib is a potent anti-inflammatory agent for the treatment of chronic obstructive pulmonary disease (COPD) and other inflammatory lung diseases. The Cytochrome P450 3A4 (CYP3A4) is a major route of clearance for nemiralisib. The co-administration of drug therapies, which modulate CYP3A4, may alter the exposure of nemiralisib. Hence, this clinical drug interaction study with itraconazole (a potent CYP3A4 inhibitor) is required. The study will evaluate the PK, safety and tolerability of nemiralisib when administered alone and when administered concomitantly with repeat doses of itraconazole in healthy males and females. Subjects will receive treatment with nemiralisib alone in Period 1 and itraconazole followed by nemiralisib in Period 2 in single sequence crossover manner. Approximately 20 subjects will be enrolled such that approximately 16 evaluable subjects complete the study. Each subject will participate in the study for approximately 7 weeks including screening visit, 2 treatment periods and a follow up visit.",null,"A Single Centre, Open Label, One Sequence, Cross-over Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics of Single Inhaled Doses of Nemiralisib in Healthy Subjects",206874,"Pulmonary Disease, Chronic Obstructive","Chronic Obstructive Pulmonary Disease","Lung Diseases","Respiratory","Experimental","Subjects receiving nemiralisib and itraconazole","Eligible subjects will receive a single dose of 100 micrograms (mcg) nemiralisib on Day 1 in Period 1. Subjects will also receive a single dose of 200 milligrams (mg) itraconazole in the morning from Day 1 to Day 10 and single dose of 100 mcg nemiralisib on Day 5, one hour after the dose of itraconazole in Period 2. There will be a washout of at least 14 days between the administration of nemiralisib in Period 1 and Period 2.","Drug","Nemiralisib|Itraconazole","Nemiralisib will be given as 100 mcg via ELLIPTA Dry Powder Inhaler with 30 doses per inhaler/ 100 mcg total dose. ELLIPTAÂ® is a registered trademark of GlaxoSmithKline group of companies.|Itraconazole will be given as 100 mg per capsule per day administered orally with water",null,"Subjects receiving nemiralisib and itraconazole","\n\n * Subjects must be 18 to 75 years of age inclusive, at the time of signing the informed consent.\n * Subjects who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac evaluation.\n * Normal spirometry at Screening (FEV1 and forced vital capacity [FVC] >=80 percent of predicted. Measurements to be taken in triplicate. The highest value of each individual component must be >=80 percent of predicted).\n * A subject with a clinical abnormality or laboratory parameter(s) (except for liver function tests) outside the reference range for the population being studied may be included only if the investigator, in consultation with the medical monitor if needed, agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.\n * Body weight >50 kilograms (kg) and body mass index (BMI) within the range 18.0-35.0 kg per meter square (kg/m^2) (inclusive).\n * Male and/or female: A male subject must agree to use contraception during the treatment period and for at least 10 days after the last dose of study treatment and refrain from donating sperm during this period; a female subject is eligible to participate if she is not pregnant, not breastfeeding, and not a woman of childbearing potential (WOCBP).\n * Capable of giving signed informed consent.\n\n","\n\n * History or presence of cardiovascular, respiratory (except childhood asthma, which has now remitted), hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study treatment; or interfering with the interpretation of data.\n * Abnormal blood pressure.\n * Liver function test results above the upper limit of normal (ULN).\n * Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).\n * QT interval corrected for heart rate by Fridericia's formula (QTcF) >450 milliseconds (msec).\n * Past or intended use of over-the-counter or prescription medication including herbal medications within 14 days prior to dosing.\n * Participation in the study would result in loss of blood or blood products in excess of 500 milliliter (mL) within 90 days.\n * Exposure to more than 4 new chemical entities within 12 months prior to the first dosing day.\n * Current enrolment or past participation within the last 30 days before signing of consent in this or any other clinical study involving an investigational study treatment or any other type of medical research.\n * Presence of Hepatitis B surface antigen (HBsAg) at screening or positive Hepatitis C antibody test result at screening.\n * Positive Hepatitis C ribonucleic acid (RNA) test result at screening or within 3 months prior to first dose of study treatment.\n * Positive human immunodeficiency virus (HIV) antibody test (according to local policies).\n * Positive drug/alcohol test at screening or on admission (Day -1).\n * Regular use of known drugs of abuse.\n * Regular alcohol consumption within 6 months prior to the study defined as: an average weekly intake of >14 drinks for males or >7 drinks for females. One drink is equivalent to 12 grams (g) of alcohol: 12 ounces (360 mL) of beer, 5 ounces (150 mL) of wine or 1.5 ounces (45 mL) of 80 proof distilled spirits.\n * Urinary cotinine levels indicative of smoking or history of regular use of tobacco- or nicotine-containing products within 6 months of screening, or a total pack year history of >5 pack years. [number of pack years = (number of cigarettes per day/20) x number of years smoked].\n * Sensitivity to any of the study treatments, or components thereof (including lactose and Magnesium Stearate), or drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the study.\n * Unwillingness to follow the lifestyle restrictions.",{"$nulls":4},"Actual","2018-01-12","Actual","Anticipated","2018-03-13","Anticipated","2018-02-01","2018-01-08","2018-01-08","2018-02-08",null,"Nemiralisib\nPharmacokinetics\nItraconazole\nDrug-drug Interaction\nCross-over","Interventional","Treatment","Crossover Assignment","None (Open Label)","Non-Randomized","18 Years","75 Years","All",null,"Yes","Yes\nIPD for this study will be made available via the Clinical Study Data Request site.",{"$nulls":3},"Yes","No",{"$nulls":19},"Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUC [0-infinity]) of nemiralisib following administration of itraconazole in Period 2|Area under the plasma concentration versus time curve from time zero to t (AUC [0-t]) of nemiralisib following administration of itraconazole in Period 2|Maximum observed plasma concentration (Cmax) of nemiralisib following administration of itraconazole in Period 2|Time to Cmax (Tmax) of nemiralisib following administration of itraconazole in Period 2|Terminal phase half-life (T1/2) of nemiralisib following administration of itraconazole in Period 2","Blood samples will be collected for pharmacokinetic analysis of nemiralisib following repeat doses of itraconazole.|Blood samples will be collected for pharmacokinetic analysis of nemiralisib following repeat doses of itraconazole","Pre-dose, and 5, 30 minutes, 2 , 6, 12, 24, 48, 72, 96, 120 and 144 hours post-dose","Number of subjects with adverse events (AEs)|Number of subjects with serious AEs (SAEs)|Number of subjects with abnormal clinical chemistry laboratory parameters|Number of subjects with abnormal hematology laboratory parameters|Number of subjects with abnormal values for urinalysis|Number of subjects with abnormal values for blood pressure|Number of subjects with abnormal values for body temperature|Number of subjects with abnormal pulse rate|Number of subjects with abnormal respiratory rate|Number of subjects with abnormal electrocardiogram (ECG) findings|Forced expiratory volume in 1 second (FEV1) following doing with nemiralisib when dosed alone and concomitantly with itraconazole|AUC (0-infinity) of itraconazole when co-administered with nemiralisib in Period 2|AUC (0-infinity) of hydroxy-itraconazole when co-administered with nemiralisib in Period 2|AUC (0-t) of itraconazole when co-administered with nemiralisib in Period 2|AUC (0-t) of hydroxy-itraconazole when co-administered with nemiralisib in Period 2|Cmax of itraconazole when co-administered with nemiralisib in Period 2|Cmax of hydroxy-itraconazole when co-administered with nemiralisib in Period 2|Tmax of itraconazole when co-administered with nemiralisib in Period 2|Tmax of hydroxy-itraconazole when co-administered with nemiralisib in Period 2|T1/2 of itraconazole when co-administered with nemiralisib in Period 2|T1/2 of hydroxy-itraconazole when co-administered with nemiralisib in Period 2","An AE is any untoward medical occurrence in a clinical study subject, temporally associated with the use of a study treatment, whether or not considered related to the study treatment.|Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment will be categorized as SAE.|Clinical chemistry parameters will be analyzed as a measure of safety including blood urea nitrogen (BUN), potassium, aspartate aminotransferase (AST)/Serum Glutamic-Oxaloacetic Transaminase (SGOT), total and direct bilirubin, creatinine, sodium, alanine aminotransferase (ALT)/Serum Glutamic-Pyruvic Transaminase (SGPT), total protein, glucose, calcium and alkaline phosphatase.|Hematology parameters will be analyzed as a measure of safety including platelet count, red blood cell (RBC) count, hemoglobin, hematocrit, mean corpuscular volume, mean corpuscular hemoglobin, percent reticulocytes, neutrophils, lymphocytes, monocytes, eosinophils and basophils.|Urinalysis parameters will be analyzed including specific gravity. The dipstick method will be used to analyze potential of hydrogen (pH), glucose, protein, blood, ketones, bilirubin, urobilinogen, nitrite, leukocyte esterase. Microscopic examination will be performed if blood or protein is abnormal.|Systolic and diastolic blood pressure will be measured in a supine or semi-supine position after 5 minutes rest.|Body temperature will be measured in a supine or semi-supine position after at least a 5 minutes rest.|Pulse rate will be measured in a supine or semi-supine position after 5 minutes rest.|Respiratory rate will be measured in a supine or semi-supine position after at least a 5 minutes rest.|A 12-lead ECGs will be measured in a supine or semi-supine position after 5 minutes rest at each time point using ECG machine.|FEV1 is defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 is a measure of lung function which will be assessed by spirometry.|Blood samples will be collected for pharmacokinetic analysis of itraconazole when co-administered with nemiralisib.|Blood samples will be collected for pharmacokinetic analysis of hydroxy-itraconazole when co-administered with nemiralisib.","Up to 41 days|Screening and up to 41 days|Up to 30 days|Up to Day 4|Pre-dose, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose on Day 1 and Day 5; 24 hours post-dose on Day 5",{"$nulls":3},"Overland Park, Kansas, United States, 66211","Kansas","United States","Gsk Investigational Site",{"$nulls":3},"GSK Clinical Trials","2018-02-08","2020-05-25T16:36:39.694","2020-05-26T17:10:42.972","NCT03398421"]
["5ecbf417feab101b15530875","NCT03398421","2018-03-12","GlaxoSmithKline","GSK","Completed","A Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics (PK) of Nemiralisib","Nemiralisib|Itraconazole","PI3K Inhibitor|CYP3A4 Inhibitor","Yes","['Nemiralisib']","No",null,"Phase 1",1,20,"Actual","2018-01-17","2018-03-03","AUC","Area Under The Curve",{"$nulls":3},"Nemiralisib is a potent anti-inflammatory agent for the treatment of chronic obstructive pulmonary disease (COPD) and other inflammatory lung diseases. The Cytochrome P450 3A4 (CYP3A4) is a major route of clearance for nemiralisib. The co-administration of drug therapies, which modulate CYP3A4, may alter the exposure of nemiralisib. Hence, this clinical drug interaction study with itraconazole (a potent CYP3A4 inhibitor) is required. The study will evaluate the PK, safety and tolerability of nemiralisib when administered alone and when administered concomitantly with repeat doses of itraconazole in healthy males and females. Subjects will receive treatment with nemiralisib alone in Period 1 and itraconazole followed by nemiralisib in Period 2 in single sequence crossover manner. Approximately 20 subjects will be enrolled such that approximately 16 evaluable subjects complete the study. Each subject will participate in the study for approximately 7 weeks including screening visit, 2 treatment periods and a follow up visit.",null,"A Single Centre, Open Label, One Sequence, Cross-over Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics of Single Inhaled Doses of Nemiralisib in Healthy Subjects",206874,"Pulmonary Disease, Chronic Obstructive","Chronic Obstructive Pulmonary Disease","Lung Diseases","Respiratory","Experimental","Subjects receiving nemiralisib and itraconazole","Eligible subjects will receive a single dose of 100 micrograms (mcg) nemiralisib on Day 1 in Period 1. Subjects will also receive a single dose of 200 milligrams (mg) itraconazole in the morning from Day 1 to Day 10 and single dose of 100 mcg nemiralisib on Day 5, one hour after the dose of itraconazole in Period 2. There will be a washout of at least 14 days between the administration of nemiralisib in Period 1 and Period 2.","Drug","Nemiralisib|Itraconazole","Nemiralisib will be given as 100 mcg via ELLIPTA Dry Powder Inhaler with 30 doses per inhaler/ 100 mcg total dose. ELLIPTAÂ® is a registered trademark of GlaxoSmithKline group of companies.|Itraconazole will be given as 100 mg per capsule per day administered orally with water",null,"Subjects receiving nemiralisib and itraconazole","\n\n * Subjects must be 18 to 75 years of age inclusive, at the time of signing the informed consent.\n * Subjects who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac evaluation.\n * Normal spirometry at Screening (FEV1 and forced vital capacity [FVC] >=80 percent of predicted. Measurements to be taken in triplicate. The highest value of each individual component must be >=80 percent of predicted).\n * A subject with a clinical abnormality or laboratory parameter(s) (except for liver function tests) outside the reference range for the population being studied may be included only if the investigator, in consultation with the medical monitor if needed, agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.\n * Body weight >50 kilograms (kg) and body mass index (BMI) within the range 18.0-35.0 kg per meter square (kg/m^2) (inclusive).\n * Male and/or female: A male subject must agree to use contraception during the treatment period and for at least 10 days after the last dose of study treatment and refrain from donating sperm during this period; a female subject is eligible to participate if she is not pregnant, not breastfeeding, and not a woman of childbearing potential (WOCBP).\n * Capable of giving signed informed consent.\n\n","\n\n * History or presence of cardiovascular, respiratory (except childhood asthma, which has now remitted), hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study treatment; or interfering with the interpretation of data.\n * Abnormal blood pressure.\n * Liver function test results above the upper limit of normal (ULN).\n * Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).\n * QT interval corrected for heart rate by Fridericia's formula (QTcF) >450 milliseconds (msec).\n * Past or intended use of over-the-counter or prescription medication including herbal medications within 14 days prior to dosing.\n * Participation in the study would result in loss of blood or blood products in excess of 500 milliliter (mL) within 90 days.\n * Exposure to more than 4 new chemical entities within 12 months prior to the first dosing day.\n * Current enrolment or past participation within the last 30 days before signing of consent in this or any other clinical study involving an investigational study treatment or any other type of medical research.\n * Presence of Hepatitis B surface antigen (HBsAg) at screening or positive Hepatitis C antibody test result at screening.\n * Positive Hepatitis C ribonucleic acid (RNA) test result at screening or within 3 months prior to first dose of study treatment.\n * Positive human immunodeficiency virus (HIV) antibody test (according to local policies).\n * Positive drug/alcohol test at screening or on admission (Day -1).\n * Regular use of known drugs of abuse.\n * Regular alcohol consumption within 6 months prior to the study defined as: an average weekly intake of >14 drinks for males or >7 drinks for females. One drink is equivalent to 12 grams (g) of alcohol: 12 ounces (360 mL) of beer, 5 ounces (150 mL) of wine or 1.5 ounces (45 mL) of 80 proof distilled spirits.\n * Urinary cotinine levels indicative of smoking or history of regular use of tobacco- or nicotine-containing products within 6 months of screening, or a total pack year history of >5 pack years. [number of pack years = (number of cigarettes per day/20) x number of years smoked].\n * Sensitivity to any of the study treatments, or components thereof (including lactose and Magnesium Stearate), or drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the study.\n * Unwillingness to follow the lifestyle restrictions.",{"$nulls":4},"Actual","2018-01-12","Actual","Actual","2018-03-03","Actual","2018-03-01","2018-01-08","2018-01-08","2018-03-08",null,"Nemiralisib\nPharmacokinetics\nItraconazole\nDrug-drug Interaction\nCross-over","Interventional","Treatment","Crossover Assignment","None (Open Label)","Non-Randomized","18 Years","75 Years","All",null,"Yes","Yes\nIPD for this study will be made available via the Clinical Study Data Request site.",{"$nulls":3},"Yes","No",{"$nulls":19},"Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUC [0-infinity]) of nemiralisib following administration of itraconazole in Period 2|Area under the plasma concentration versus time curve from time zero to t (AUC [0-t]) of nemiralisib following administration of itraconazole in Period 2|Maximum observed plasma concentration (Cmax) of nemiralisib following administration of itraconazole in Period 2|Time to Cmax (Tmax) of nemiralisib following administration of itraconazole in Period 2|Terminal phase half-life (T1/2) of nemiralisib following administration of itraconazole in Period 2","Blood samples will be collected for pharmacokinetic analysis of nemiralisib following repeat doses of itraconazole.|Blood samples will be collected for pharmacokinetic analysis of nemiralisib following repeat doses of itraconazole","Pre-dose, and 5, 30 minutes, 2 , 6, 12, 24, 48, 72, 96, 120 and 144 hours post-dose","Number of subjects with adverse events (AEs)|Number of subjects with serious AEs (SAEs)|Number of subjects with abnormal clinical chemistry laboratory parameters|Number of subjects with abnormal hematology laboratory parameters|Number of subjects with abnormal values for urinalysis|Number of subjects with abnormal values for blood pressure|Number of subjects with abnormal values for body temperature|Number of subjects with abnormal pulse rate|Number of subjects with abnormal respiratory rate|Number of subjects with abnormal electrocardiogram (ECG) findings|Forced expiratory volume in 1 second (FEV1) following doing with nemiralisib when dosed alone and concomitantly with itraconazole|AUC (0-infinity) of itraconazole when co-administered with nemiralisib in Period 2|AUC (0-infinity) of hydroxy-itraconazole when co-administered with nemiralisib in Period 2|AUC (0-t) of itraconazole when co-administered with nemiralisib in Period 2|AUC (0-t) of hydroxy-itraconazole when co-administered with nemiralisib in Period 2|Cmax of itraconazole when co-administered with nemiralisib in Period 2|Cmax of hydroxy-itraconazole when co-administered with nemiralisib in Period 2|Tmax of itraconazole when co-administered with nemiralisib in Period 2|Tmax of hydroxy-itraconazole when co-administered with nemiralisib in Period 2|T1/2 of itraconazole when co-administered with nemiralisib in Period 2|T1/2 of hydroxy-itraconazole when co-administered with nemiralisib in Period 2","An AE is any untoward medical occurrence in a clinical study subject, temporally associated with the use of a study treatment, whether or not considered related to the study treatment.|Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment will be categorized as SAE.|Clinical chemistry parameters will be analyzed as a measure of safety including blood urea nitrogen (BUN), potassium, aspartate aminotransferase (AST)/Serum Glutamic-Oxaloacetic Transaminase (SGOT), total and direct bilirubin, creatinine, sodium, alanine aminotransferase (ALT)/Serum Glutamic-Pyruvic Transaminase (SGPT), total protein, glucose, calcium and alkaline phosphatase.|Hematology parameters will be analyzed as a measure of safety including platelet count, red blood cell (RBC) count, hemoglobin, hematocrit, mean corpuscular volume, mean corpuscular hemoglobin, percent reticulocytes, neutrophils, lymphocytes, monocytes, eosinophils and basophils.|Urinalysis parameters will be analyzed including specific gravity. The dipstick method will be used to analyze potential of hydrogen (pH), glucose, protein, blood, ketones, bilirubin, urobilinogen, nitrite, leukocyte esterase. Microscopic examination will be performed if blood or protein is abnormal.|Systolic and diastolic blood pressure will be measured in a supine or semi-supine position after 5 minutes rest.|Body temperature will be measured in a supine or semi-supine position after at least a 5 minutes rest.|Pulse rate will be measured in a supine or semi-supine position after 5 minutes rest.|Respiratory rate will be measured in a supine or semi-supine position after at least a 5 minutes rest.|A 12-lead ECGs will be measured in a supine or semi-supine position after 5 minutes rest at each time point using ECG machine.|FEV1 is defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 is a measure of lung function which will be assessed by spirometry.|Blood samples will be collected for pharmacokinetic analysis of itraconazole when co-administered with nemiralisib.|Blood samples will be collected for pharmacokinetic analysis of hydroxy-itraconazole when co-administered with nemiralisib.","Up to 41 days|Screening and up to 41 days|Up to 30 days|Up to Day 4|Pre-dose, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose on Day 1 and Day 5; 24 hours post-dose on Day 5",{"$nulls":3},"Overland Park, Kansas, United States, 66211","Kansas","United States","Gsk Investigational Site",{"$nulls":3},"GSK Clinical Trials","2018-03-08","2020-05-25T16:36:39.598","2020-05-26T17:10:42.972","NCT03398421"]
["5ecbf417e2561b1b11905d41","NCT03398421","2019-01-15","GlaxoSmithKline","GSK","Completed","A Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics (PK) of Nemiralisib","Nemiralisib|Itraconazole","PI3K Inhibitor|CYP3A4 Inhibitor","Yes","['Nemiralisib']","No",null,"Phase 1",1,20,"Actual","2018-01-17","2018-03-12","AUC","Area Under The Curve",{"$nulls":3},"Nemiralisib is a potent anti-inflammatory agent for the treatment of chronic obstructive pulmonary disease (COPD) and other inflammatory lung diseases. The Cytochrome P450 3A4 (CYP3A4) is a major route of clearance for nemiralisib. The co-administration of drug therapies, which modulate CYP3A4, may alter the exposure of nemiralisib. Hence, this clinical drug interaction study with itraconazole (a potent CYP3A4 inhibitor) is required. The study will evaluate the PK, safety and tolerability of nemiralisib when administered alone and when administered concomitantly with repeat doses of itraconazole in healthy males and females. Subjects will receive treatment with nemiralisib alone in Period 1 and itraconazole followed by nemiralisib in Period 2 in single sequence crossover manner. Approximately 20 subjects will be enrolled such that approximately 16 evaluable subjects complete the study. Each subject will participate in the study for approximately 7 weeks including screening visit, 2 treatment periods and a follow up visit.",null,"A Single Centre, Open Label, One Sequence, Cross-over Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics of Single Inhaled Doses of Nemiralisib in Healthy Subjects",206874,"Pulmonary Disease, Chronic Obstructive","Chronic Obstructive Pulmonary Disease","Lung Diseases","Respiratory","Experimental","Subjects receiving nemiralisib and itraconazole","Eligible subjects will receive a single dose of 100 micrograms (mcg) nemiralisib on Day 1 in Period 1. Subjects will also receive a single dose of 200 milligrams (mg) itraconazole in the morning from Day 1 to Day 10 and single dose of 100 mcg nemiralisib on Day 5, one hour after the dose of itraconazole in Period 2. There will be a washout of at least 14 days between the administration of nemiralisib in Period 1 and Period 2.","Drug","Nemiralisib|Itraconazole","Nemiralisib will be given as 100 mcg via ELLIPTA Dry Powder Inhaler with 30 doses per inhaler/ 100 mcg total dose. ELLIPTAÂ® is a registered trademark of GlaxoSmithKline group of companies.|Itraconazole will be given as 100 mg per capsule per day administered orally with water",null,"Subjects receiving nemiralisib and itraconazole","\n\n * Subjects must be 18 to 75 years of age inclusive, at the time of signing the informed consent.\n * Subjects who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac evaluation.\n * Normal spirometry at Screening (FEV1 and forced vital capacity [FVC] >=80 percent of predicted. Measurements to be taken in triplicate. The highest value of each individual component must be >=80 percent of predicted).\n * A subject with a clinical abnormality or laboratory parameter(s) (except for liver function tests) outside the reference range for the population being studied may be included only if the investigator, in consultation with the medical monitor if needed, agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.\n * Body weight >50 kilograms (kg) and body mass index (BMI) within the range 18.0-35.0 kg per meter square (kg/m^2) (inclusive).\n * Male and/or female: A male subject must agree to use contraception during the treatment period and for at least 10 days after the last dose of study treatment and refrain from donating sperm during this period; a female subject is eligible to participate if she is not pregnant, not breastfeeding, and not a woman of childbearing potential (WOCBP).\n * Capable of giving signed informed consent.\n\n","\n\n * History or presence of cardiovascular, respiratory (except childhood asthma, which has now remitted), hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study treatment; or interfering with the interpretation of data.\n * Abnormal blood pressure.\n * Liver function test results above the upper limit of normal (ULN).\n * Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).\n * QT interval corrected for heart rate by Fridericia's formula (QTcF) >450 milliseconds (msec).\n * Past or intended use of over-the-counter or prescription medication including herbal medications within 14 days prior to dosing.\n * Participation in the study would result in loss of blood or blood products in excess of 500 milliliter (mL) within 90 days.\n * Exposure to more than 4 new chemical entities within 12 months prior to the first dosing day.\n * Current enrolment or past participation within the last 30 days before signing of consent in this or any other clinical study involving an investigational study treatment or any other type of medical research.\n * Presence of Hepatitis B surface antigen (HBsAg) at screening or positive Hepatitis C antibody test result at screening.\n * Positive Hepatitis C ribonucleic acid (RNA) test result at screening or within 3 months prior to first dose of study treatment.\n * Positive human immunodeficiency virus (HIV) antibody test (according to local policies).\n * Positive drug/alcohol test at screening or on admission (Day -1).\n * Regular use of known drugs of abuse.\n * Regular alcohol consumption within 6 months prior to the study defined as: an average weekly intake of >14 drinks for males or >7 drinks for females. One drink is equivalent to 12 grams (g) of alcohol: 12 ounces (360 mL) of beer, 5 ounces (150 mL) of wine or 1.5 ounces (45 mL) of 80 proof distilled spirits.\n * Urinary cotinine levels indicative of smoking or history of regular use of tobacco- or nicotine-containing products within 6 months of screening, or a total pack year history of >5 pack years. [number of pack years = (number of cigarettes per day/20) x number of years smoked].\n * Sensitivity to any of the study treatments, or components thereof (including lactose and Magnesium Stearate), or drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the study.\n * Unwillingness to follow the lifestyle restrictions.",{"$nulls":4},"Actual","2018-01-12","Actual","Actual","2018-03-12","Actual","2019-01-01","2018-01-08","2018-01-08","2019-01-11",null,"Nemiralisib\nPharmacokinetics\nItraconazole\nDrug-drug Interaction\nCross-over","Interventional","Treatment","Crossover Assignment","None (Open Label)","Non-Randomized","18 Years","75 Years","All",null,"Yes","Yes\nIPD for this study will be made available via the Clinical Study Data Request site.",{"$nulls":3},"Yes","No",{"$nulls":19},"Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUC [0-infinity]) of nemiralisib following administration of itraconazole in Period 2|Area under the plasma concentration versus time curve from time zero to t (AUC [0-t]) of nemiralisib following administration of itraconazole in Period 2|Maximum observed plasma concentration (Cmax) of nemiralisib following administration of itraconazole in Period 2|Time to Cmax (Tmax) of nemiralisib following administration of itraconazole in Period 2|Terminal phase half-life (T1/2) of nemiralisib following administration of itraconazole in Period 2","Blood samples will be collected for pharmacokinetic analysis of nemiralisib following repeat doses of itraconazole.|Blood samples will be collected for pharmacokinetic analysis of nemiralisib following repeat doses of itraconazole","Pre-dose, and 5, 30 minutes, 2 , 6, 12, 24, 48, 72, 96, 120 and 144 hours post-dose","Number of subjects with adverse events (AEs)|Number of subjects with serious AEs (SAEs)|Number of subjects with abnormal clinical chemistry laboratory parameters|Number of subjects with abnormal hematology laboratory parameters|Number of subjects with abnormal values for urinalysis|Number of subjects with abnormal values for blood pressure|Number of subjects with abnormal values for body temperature|Number of subjects with abnormal pulse rate|Number of subjects with abnormal respiratory rate|Number of subjects with abnormal electrocardiogram (ECG) findings|Forced expiratory volume in 1 second (FEV1) following doing with nemiralisib when dosed alone and concomitantly with itraconazole|AUC (0-infinity) of itraconazole when co-administered with nemiralisib in Period 2|AUC (0-infinity) of hydroxy-itraconazole when co-administered with nemiralisib in Period 2|AUC (0-t) of itraconazole when co-administered with nemiralisib in Period 2|AUC (0-t) of hydroxy-itraconazole when co-administered with nemiralisib in Period 2|Cmax of itraconazole when co-administered with nemiralisib in Period 2|Cmax of hydroxy-itraconazole when co-administered with nemiralisib in Period 2|Tmax of itraconazole when co-administered with nemiralisib in Period 2|Tmax of hydroxy-itraconazole when co-administered with nemiralisib in Period 2|T1/2 of itraconazole when co-administered with nemiralisib in Period 2|T1/2 of hydroxy-itraconazole when co-administered with nemiralisib in Period 2","An AE is any untoward medical occurrence in a clinical study subject, temporally associated with the use of a study treatment, whether or not considered related to the study treatment.|Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment will be categorized as SAE.|Clinical chemistry parameters will be analyzed as a measure of safety including blood urea nitrogen (BUN), potassium, aspartate aminotransferase (AST)/Serum Glutamic-Oxaloacetic Transaminase (SGOT), total and direct bilirubin, creatinine, sodium, alanine aminotransferase (ALT)/Serum Glutamic-Pyruvic Transaminase (SGPT), total protein, glucose, calcium and alkaline phosphatase.|Hematology parameters will be analyzed as a measure of safety including platelet count, red blood cell (RBC) count, hemoglobin, hematocrit, mean corpuscular volume, mean corpuscular hemoglobin, percent reticulocytes, neutrophils, lymphocytes, monocytes, eosinophils and basophils.|Urinalysis parameters will be analyzed including specific gravity. The dipstick method will be used to analyze potential of hydrogen (pH), glucose, protein, blood, ketones, bilirubin, urobilinogen, nitrite, leukocyte esterase. Microscopic examination will be performed if blood or protein is abnormal.|Systolic and diastolic blood pressure will be measured in a supine or semi-supine position after 5 minutes rest.|Body temperature will be measured in a supine or semi-supine position after at least a 5 minutes rest.|Pulse rate will be measured in a supine or semi-supine position after 5 minutes rest.|Respiratory rate will be measured in a supine or semi-supine position after at least a 5 minutes rest.|A 12-lead ECGs will be measured in a supine or semi-supine position after 5 minutes rest at each time point using ECG machine.|FEV1 is defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 is a measure of lung function which will be assessed by spirometry.|Blood samples will be collected for pharmacokinetic analysis of itraconazole when co-administered with nemiralisib.|Blood samples will be collected for pharmacokinetic analysis of hydroxy-itraconazole when co-administered with nemiralisib.","Up to 41 days|Screening and up to 41 days|Up to 30 days|Up to Day 4|Pre-dose, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose on Day 1 and Day 5; 24 hours post-dose on Day 5",{"$nulls":3},"Overland Park, Kansas, United States, 66211","Kansas","United States","Gsk Investigational Site",{"$nulls":3},"GSK Clinical Trials","2019-01-11","2020-05-25T16:36:39.788","2020-05-26T17:10:42.972","NCT03398421"]
["5ecbf418307e3d1b1f8d9cd7","NCT03398421","2020-04-27","GlaxoSmithKline","GSK","Completed","A Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics (PK) of Nemiralisib","Nemiralisib|Itraconazole","PI3K Inhibitor|CYP3A4 Inhibitor","Yes","['Nemiralisib']","No",null,"Phase 1",1,20,"Actual","2018-01-17","2018-03-12",{"$nulls":5},"Nemiralisib is a potent anti-inflammatory agent for the treatment of chronic obstructive pulmonary disease (COPD) and other inflammatory lung diseases. The Cytochrome P450 3A4 (CYP3A4) is a major route of clearance for nemiralisib. The co-administration of drug therapies, which modulate CYP3A4, may alter the exposure of nemiralisib. Hence, this clinical drug interaction study with itraconazole (a potent CYP3A4 inhibitor) is required. The study will evaluate the PK, safety and tolerability of nemiralisib when administered alone and when administered concomitantly with repeat doses of itraconazole in healthy males and females. Subjects will receive treatment with nemiralisib alone in Period 1 and itraconazole followed by nemiralisib in Period 2 in single sequence crossover manner. Approximately 20 subjects will be enrolled such that approximately 16 evaluable subjects complete the study. Each subject will participate in the study for approximately 7 weeks including screening visit, 2 treatment periods and a follow up visit.",null,"A Single Centre, Open Label, One Sequence, Cross-over Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics of Single Inhaled Doses of Nemiralisib in Healthy Subjects",206874,"Pulmonary Disease, Chronic Obstructive","Chronic Obstructive Pulmonary Disease","Lung Diseases","Respiratory","Experimental","Subjects receiving nemiralisib and itraconazole","Eligible subjects will receive a single dose of 100 micrograms (mcg) nemiralisib on Day 1 in Period 1. Subjects will also receive a single dose of 200 milligrams (mg) itraconazole in the morning from Day 1 to Day 10 and single dose of 100 mcg nemiralisib on Day 5, one hour after the dose of itraconazole in Period 2. There will be a washout of at least 14 days between the administration of nemiralisib in Period 1 and Period 2.","Drug","Nemiralisib|Itraconazole","Nemiralisib will be given as 100 mcg via ELLIPTA Dry Powder Inhaler with 30 doses per inhaler/ 100 mcg total dose. ELLIPTAÂ® is a registered trademark of GlaxoSmithKline group of companies.|Itraconazole will be given as 100 mg per capsule per day administered orally with water",null,"Subjects receiving nemiralisib and itraconazole","\n\n * Subjects must be 18 to 75 years of age inclusive, at the time of signing the informed consent.\n * Subjects who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac evaluation.\n * Normal spirometry at Screening (FEV1 and forced vital capacity [FVC] >=80 percent of predicted. Measurements to be taken in triplicate. The highest value of each individual component must be >=80 percent of predicted).\n * A subject with a clinical abnormality or laboratory parameter(s) (except for liver function tests) outside the reference range for the population being studied may be included only if the investigator, in consultation with the medical monitor if needed, agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.\n * Body weight >50 kilograms (kg) and body mass index (BMI) within the range 18.0-35.0 kg per meter square (kg/m^2) (inclusive).\n * Male and/or female: A male subject must agree to use contraception during the treatment period and for at least 10 days after the last dose of study treatment and refrain from donating sperm during this period; a female subject is eligible to participate if she is not pregnant, not breastfeeding, and not a woman of childbearing potential (WOCBP).\n * Capable of giving signed informed consent.\n\n","\n\n * History or presence of cardiovascular, respiratory (except childhood asthma, which has now remitted), hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study treatment; or interfering with the interpretation of data.\n * Abnormal blood pressure.\n * Liver function test results above the upper limit of normal (ULN).\n * Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).\n * QT interval corrected for heart rate by Fridericia's formula (QTcF) >450 milliseconds (msec).\n * Past or intended use of over-the-counter or prescription medication including herbal medications within 14 days prior to dosing.\n * Participation in the study would result in loss of blood or blood products in excess of 500 milliliter (mL) within 90 days.\n * Exposure to more than 4 new chemical entities within 12 months prior to the first dosing day.\n * Current enrolment or past participation within the last 30 days before signing of consent in this or any other clinical study involving an investigational study treatment or any other type of medical research.\n * Presence of Hepatitis B surface antigen (HBsAg) at screening or positive Hepatitis C antibody test result at screening.\n * Positive Hepatitis C ribonucleic acid (RNA) test result at screening or within 3 months prior to first dose of study treatment.\n * Positive human immunodeficiency virus (HIV) antibody test (according to local policies).\n * Positive drug/alcohol test at screening or on admission (Day -1).\n * Regular use of known drugs of abuse.\n * Regular alcohol consumption within 6 months prior to the study defined as: an average weekly intake of >14 drinks for males or >7 drinks for females. One drink is equivalent to 12 grams (g) of alcohol: 12 ounces (360 mL) of beer, 5 ounces (150 mL) of wine or 1.5 ounces (45 mL) of 80 proof distilled spirits.\n * Urinary cotinine levels indicative of smoking or history of regular use of tobacco- or nicotine-containing products within 6 months of screening, or a total pack year history of >5 pack years. [number of pack years = (number of cigarettes per day/20) x number of years smoked].\n * Sensitivity to any of the study treatments, or components thereof (including lactose and Magnesium Stearate), or drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the study.\n * Unwillingness to follow the lifestyle restrictions.",{"$nulls":4},"Actual","2018-01-12","Actual","Actual","2018-03-12","Actual","2020-04-01","2018-01-08","2018-01-08","2020-04-10",null,"Nemiralisib\nPharmacokinetics\nItraconazole\nDrug-drug Interaction\nCross-over","Interventional","Treatment","Crossover Assignment","None (Open Label)","Non-Randomized","18 Years","75 Years","All",null,"Yes","Yes\nIPD for this study will be made available via the Clinical Study Data Request site.","Patel A, Wilson R, Harrell AW, Taskar KS, Taylor M, Tracey H, Riddell K, Georgiou A, Cahn AP, Marotti M, Hessel EM. Drug Interactions for Low-Dose Inhaled Nemiralisib: A Case Study Integrating Modeling, In Vitro, and Clinical Investigations. Drug Metab Dispos. 2020 Apr;48(4):307-316. doi: 10.1124/dmd.119.089003. Epub 2020 Feb 2. PubMed 32009006",null,null,"Yes","No","2019-02-27","2019-02-27","2019-06-03","Actual",{"$nulls":24},"Overland Park, Kansas, United States, 66211","Kansas","United States","Gsk Investigational Site",{"$nulls":3},"GSK Clinical Trials","2020-04-10","2020-05-25T16:36:40.167","2020-05-26T17:10:42.972","NCT03398421"]
["5ecbf41811702c1b1b916a57","NCT03398434","2018-09-12","Novartis","NVS","Withdrawn","Efficacy and Safety of MAA868 in Patients With Atrial Fibrillation","Maa868|Apixaban","FXIa Inhibitor|VKOR Antagonist|FXa Inhibitor","Yes","['Maa868']","Yes","['FXIa Inhibitor']","Phase 2",4,0,"Actual","2018-10-16","2019-11-28",{"$nulls":5},"The purpose of this study is to evaluate the pharmacokinetics, pharmacodynamics, safety and tolerability of MAA868 compared to apixaban in patients with atrial fibrillation.",null,"A Multicenter, Randomized, Open-label, Active-controlled, Dose-range Finding Study to Assess the Pharmacodynamic Parameters, Safety and Tolerability of MAA868 and Its Effect on Thrombogenesis Biomarkers Compared to Apixaban in Patients With Atrial Fibrillation","CMAA868A2202","Atrial Fibrillation","Atrial Fibrillation","Heart Diseases","Cardiovascular","Experimental|Active Comparator","MAA868 low dose regimen|MAA868 middle dose regimen|MAA868 high dose regimen|Apixaban","patients receive dose monthly.|Apixaban 5 mg b.i.d","Drug","MAA868|Apixaban","3 MAA868 doses, single administration, subcutaneous,|Apixaban 5 mg b.i.d",null,"MAA868 low dose regimen|MAA868 middle dose regimen|MAA868 high dose regimen|Apixaban","\n\n * Male and female patients â‰¥ 55 and < 85 years old\n * Body weight between 50 and 130 kg inclusive\n * Atrial fibrillation or atrial flutter, as documented by electrocardiography\n * CHA2DS2-VASc risk score â‰¥ 2 for male and female patients. Male patients with CHA2DS2VASc risk score of 1 can be included if anticoagulation therapy is warranted.\n * Either anticoagulant-naÃ¯ve or receiving a stable treatment of a recommended dose of a new oral anticoagulant (NOAC) over the 8 weeks prior to screening.\n\n","\n\n * History of stroke, transient ischemic attack or systemic embolism\n * History of major bleeding during treatment with an anticoagulant or antiplatelet therapy in the last 12 months\n * History of traumatic or non-traumatic intracranial, intraspinal or intra-ocular bleeding\n * Known bleeding diathesis or any known active bleeding site at screening or baseline\n * Family history of bleeding disorder\n * Known active GI lesions predisposing to bleeding events\n * Myocardial infarction, unstable angina pectoris or coronary artery bypass graft (CABG) surgery within 12 months prior to the screening period\n * Known hemodynamically significant valvular heart disease\n * Uncontrolled hypertension defined as SBP/DBP â‰¥ 160/100 mmHg at the screening visit\n * Heart failure NYHA class IV in the 3 months prior to the screening visit\n * Dual antiplatelet therapy. Treatment with a P2Y12 inhibitor or low dose aspirin (â‰¤ 100 mg/d) is allowed but not both.\n * Severe renal impairment (creatinine clearance < 30 mL/min) at the screening visit",{"$nulls":4},"Actual","2018-01-12","Actual","Anticipated","2020-01-30","Anticipated","2018-09-01","2018-01-08","2018-01-08","2018-09-10","Yes","MAA868\napixaban\natrial fibrillation\nanticoagulant\nFactor XI\nD-dimer\nsystemic thromboembolic events","Interventional","Basic Science","Parallel Assignment","Single (Outcomes Assessor)","Randomized","55 Years","85 Years","All",null,"No","Undecided\nNovartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",{"$nulls":3},"No","No",{"$nulls":17},"2017-002741-29","EudraCT Number","number of patients achieving FXI inhibition â‰¥ 80% at trough after monthly dosing at 3 dose levels of MAA868 inhibition","Occurrence of achieving â‰¥ 80% inhibition of FXI (< 20% free FXI) following 3 months of treatment.","month 3","number of patients achieving FXI inhibition â‰¥ 80% at trough after the first and second dose at 3 dose levels of MAA868|Number of patients with incidence of major or clinically relevant non-major (CRNM) bleeding events during the treatment period.|the effect of MAA868 on D dimer and other thrombogenesis biomarkers as indicators of efficacy compared to compotator","Occurrence of achieving â‰¥ 80% inhibition of FXI (< 20% free FXI) at trough on Month 1 and Month 2|Incidence of major or clinically relevant non-major bleeding events|Change from baseline to Day 31, Day 61 and Day 91 in thrombogenesis biomarkers (D-dimer, prothrombin fragment 1.2 (F1.2), thrombin-antithrombin III-complexes (TAT), fibrinogen).","Month 1 and 2|day 1 to day 91|Days 31, 61 and 91",{"$nulls":11},"2018-09-10","2020-05-25T16:36:40.246","2020-05-26T17:10:42.972","NCT03398434"]
["5ecbf41811702c1b1b916a58","NCT03398434","2018-10-02","Novartis","NVS","Not yet recruiting","Efficacy and Safety of MAA868 in Patients With Atrial Fibrillation","Maa868|Apixaban","FXIa Inhibitor|VKOR Antagonist|FXa Inhibitor","Yes","['Maa868']","Yes","['FXIa Inhibitor']","Phase 2",4,600,"Anticipated","2018-10-16","2019-11-28",{"$nulls":5},"The purpose of this study is to evaluate the pharmacokinetics, pharmacodynamics, safety and tolerability of MAA868 compared to apixaban in patients with atrial fibrillation.",null,"A Multicenter, Randomized, Open-label, Active-controlled, Dose-range Finding Study to Assess the Pharmacodynamic Parameters, Safety and Tolerability of MAA868 and Its Effect on Thrombogenesis Biomarkers Compared to Apixaban in Patients With Atrial Fibrillation","CMAA868A2202","Atrial Fibrillation","Atrial Fibrillation","Heart Diseases","Cardiovascular","Experimental|Active Comparator","MAA868 low dose regimen|MAA868 middle dose regimen|MAA868 high dose regimen|Apixaban","patients receive dose monthly.|Apixaban 5 mg b.i.d","Drug","MAA868|Apixaban","3 MAA868 doses, single administration, subcutaneous,|Apixaban 5 mg b.i.d",null,"MAA868 low dose regimen|MAA868 middle dose regimen|MAA868 high dose regimen|Apixaban","\n\n * Male and female patients â‰¥ 55 and < 85 years old\n * Body weight between 50 and 130 kg inclusive\n * Atrial fibrillation or atrial flutter, as documented by electrocardiography\n * CHA2DS2-VASc risk score â‰¥ 2 for male and female patients. Male patients with CHA2DS2VASc risk score of 1 can be included if anticoagulation therapy is warranted.\n * Either anticoagulant-naÃ¯ve or receiving a stable treatment of a recommended dose of a new oral anticoagulant (NOAC) over the 8 weeks prior to screening.\n\n","\n\n * History of stroke, transient ischemic attack or systemic embolism\n * History of major bleeding during treatment with an anticoagulant or antiplatelet therapy in the last 12 months\n * History of traumatic or non-traumatic intracranial, intraspinal or intra-ocular bleeding\n * Known bleeding diathesis or any known active bleeding site at screening or baseline\n * Family history of bleeding disorder\n * Known active GI lesions predisposing to bleeding events\n * Myocardial infarction, unstable angina pectoris or coronary artery bypass graft (CABG) surgery within 12 months prior to the screening period\n * Known hemodynamically significant valvular heart disease\n * Uncontrolled hypertension defined as SBP/DBP â‰¥ 160/100 mmHg at the screening visit\n * Heart failure NYHA class IV in the 3 months prior to the screening visit\n * Dual antiplatelet therapy. Treatment with a P2Y12 inhibitor or low dose aspirin (â‰¤ 100 mg/d) is allowed but not both.\n * Severe renal impairment (creatinine clearance < 30 mL/min) at the screening visit",{"$nulls":4},"Actual","2018-01-12","Actual","Anticipated","2020-01-30","Anticipated","2018-09-01","2018-01-08","2018-01-08","2018-09-28","Yes","MAA868\napixaban\natrial fibrillation\nanticoagulant\nFactor XI\nD-dimer\nsystemic thromboembolic events","Interventional","Basic Science","Parallel Assignment","Single (Outcomes Assessor)","Randomized","55 Years","85 Years","All",null,"No","Undecided\nNovartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",{"$nulls":3},"No","No",{"$nulls":17},"2017-002741-29","EudraCT Number","number of patients achieving FXI inhibition â‰¥ 80% at trough after monthly dosing at 3 dose levels of MAA868 inhibition","Occurrence of achieving â‰¥ 80% inhibition of FXI (< 20% free FXI) following 3 months of treatment.","month 3","number of patients achieving FXI inhibition â‰¥ 80% at trough after the first and second dose at 3 dose levels of MAA868|Number of patients with incidence of major or clinically relevant non-major (CRNM) bleeding events during the treatment period.|the effect of MAA868 on D dimer and other thrombogenesis biomarkers as indicators of efficacy compared to compotator","Occurrence of achieving â‰¥ 80% inhibition of FXI (< 20% free FXI) at trough on Month 1 and Month 2|Incidence of major or clinically relevant non-major bleeding events|Change from baseline to Day 31, Day 61 and Day 91 in thrombogenesis biomarkers (D-dimer, prothrombin fragment 1.2 (F1.2), thrombin-antithrombin III-complexes (TAT), fibrinogen).","Month 1 and 2|day 1 to day 91|Days 31, 61 and 91",{"$nulls":11},"2018-09-28","2020-05-25T16:36:40.903","2020-05-26T17:10:42.972","NCT03398434"]
["5ecbf419fe30261b1a048249","NCT03398434","2019-02-21","Novartis","NVS","Withdrawn","Efficacy and Safety of MAA868 in Patients With Atrial Fibrillation","Maa868|Apixaban","FXIa Inhibitor|VKOR Antagonist|FXa Inhibitor","Yes","['Maa868']","Yes","['FXIa Inhibitor']","Phase 2",4,0,"Actual","2018-10-16","2019-11-28",{"$nulls":5},"The purpose of this study is to evaluate the pharmacokinetics, pharmacodynamics, safety and tolerability of MAA868 compared to apixaban in patients with atrial fibrillation.",null,"A Multicenter, Randomized, Open-label, Active-controlled, Dose-range Finding Study to Assess the Pharmacodynamic Parameters, Safety and Tolerability of MAA868 and Its Effect on Thrombogenesis Biomarkers Compared to Apixaban in Patients With Atrial Fibrillation","CMAA868A2202","Atrial Fibrillation","Atrial Fibrillation","Heart Diseases","Cardiovascular","Experimental|Active Comparator","MAA868 low dose regimen|MAA868 middle dose regimen|MAA868 high dose regimen|Apixaban","patients receive dose monthly.|Apixaban 5 mg b.i.d","Drug","MAA868|Apixaban","3 MAA868 doses, single administration, subcutaneous,|Apixaban 5 mg b.i.d",null,"MAA868 low dose regimen|MAA868 middle dose regimen|MAA868 high dose regimen|Apixaban","\n\n * Male and female patients â‰¥ 55 and < 85 years old\n * Body weight between 50 and 130 kg inclusive\n * Atrial fibrillation or atrial flutter, as documented by electrocardiography\n * CHA2DS2-VASc risk score â‰¥ 2 for male and female patients. Male patients with CHA2DS2VASc risk score of 1 can be included if anticoagulation therapy is warranted.\n * Either anticoagulant-naÃ¯ve or receiving a stable treatment of a recommended dose of a new oral anticoagulant (NOAC) over the 8 weeks prior to screening.\n\n","\n\n * History of stroke, transient ischemic attack or systemic embolism\n * History of major bleeding during treatment with an anticoagulant or antiplatelet therapy in the last 12 months\n * History of traumatic or non-traumatic intracranial, intraspinal or intra-ocular bleeding\n * Known bleeding diathesis or any known active bleeding site at screening or baseline\n * Family history of bleeding disorder\n * Known active GI lesions predisposing to bleeding events\n * Myocardial infarction, unstable angina pectoris or coronary artery bypass graft (CABG) surgery within 12 months prior to the screening period\n * Known hemodynamically significant valvular heart disease\n * Uncontrolled hypertension defined as SBP/DBP â‰¥ 160/100 mmHg at the screening visit\n * Heart failure NYHA class IV in the 3 months prior to the screening visit\n * Dual antiplatelet therapy. Treatment with a P2Y12 inhibitor or low dose aspirin (â‰¤ 100 mg/d) is allowed but not both.\n * Severe renal impairment (creatinine clearance < 30 mL/min) at the screening visit",{"$nulls":4},"Actual","2018-01-12","Actual","Anticipated","2020-01-30","Anticipated","2019-02-01","2018-01-08","2018-01-08","2019-02-20","Yes","MAA868\napixaban\natrial fibrillation\nanticoagulant\nFactor XI\nD-dimer\nsystemic thromboembolic events","Interventional","Basic Science","Parallel Assignment","Single (Outcomes Assessor)","Randomized","55 Years","85 Years","All",null,"No","Undecided\nNovartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",{"$nulls":3},"No","No",{"$nulls":17},"2017-002741-29","EudraCT Number","number of patients achieving FXI inhibition â‰¥ 80% at trough after monthly dosing at 3 dose levels of MAA868 inhibition","Occurrence of achieving â‰¥ 80% inhibition of FXI (< 20% free FXI) following 3 months of treatment.","month 3","number of patients achieving FXI inhibition â‰¥ 80% at trough after the first and second dose at 3 dose levels of MAA868|Number of patients with incidence of major or clinically relevant non-major (CRNM) bleeding events during the treatment period.|the effect of MAA868 on D dimer and other thrombogenesis biomarkers as indicators of efficacy compared to compotator","Occurrence of achieving â‰¥ 80% inhibition of FXI (< 20% free FXI) at trough on Month 1 and Month 2|Incidence of major or clinically relevant non-major bleeding events|Change from baseline to Day 31, Day 61 and Day 91 in thrombogenesis biomarkers (D-dimer, prothrombin fragment 1.2 (F1.2), thrombin-antithrombin III-complexes (TAT), fibrinogen).","Month 1 and 2|day 1 to day 91|Days 31, 61 and 91",{"$nulls":11},"2019-02-20","2020-05-25T16:36:41.830","2020-05-26T17:10:42.972","NCT03398434"]
["5ecbf419feab101b15530878","NCT03398473","2018-01-25","Pfizer","PFE","Not yet recruiting","A Study Comparing The Effects Of Epoetin Hospira Single-Dose Vial (SDV) And Multi-Dose Vial (MDV) When Administered Subcutaneously To Normal Healthy Subjects","Epoetin","ESA Activator","Yes","['Epoetin']","No",null,"Phase 1",2,68,"Anticipated","2018-01-01","2018-05-01","AUC|Clast","Area Under The Curve|Last Quantifiable Plasma Concentration",{"$nulls":3},"This study will assess the PK similarity of epoetin administered as Hospira MDV versus Hospira SDV by conducting a single-dose comparative evaluation in normal healthy subjects enrolled at a single center.",null,"A Phase 1, Open-label, Randomized, Single Dose, Crossover Study Evaluating The Pharmacokinetics Of Epoetin Following Administration Of Epoetin Hospira Multiple Dose Vial (Mdv) Product Compared To Epoetin Hospira Single Dose Vial (Sdv) Product As Subcutaneous Injection To Normal Healthy Subjects","C3461009","Healthy","Healthy Volunteers","Healthy","Healthy","Experimental","Epoetin Hospira SDV|Epoetin Hospira MDV","Epoetin Hospira Single Dose Vial (SDV)|Epoetin Hospira Multi-Dose Vial (MDV)","Drug","Epoetin Hospira SDV|Epoetin Hospira MDV","Epoetin Hospira Single Dose Vial|Epoetin Hospira Multi-Dose Vial",null,"Epoetin Hospira SDV|Epoetin Hospira MDV","\n\n 1. Healthy female and male subjects who, at time of Screening, are between ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination including blood pressure and pulse rate measurement, 12-lead electrocardiogram, or clinical laboratory tests.Female subjects of nonchildbearing potential must meet at least 1 of the following criteria:\n    \n     1. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; a serum follicle-stimulating hormone (FSH) level confirming the postmenopausal state.\n     2. Have undergone a documented hysterectomy and/or bilateral oophorectomy;\n     3. Have medically confirmed ovarian failure.\n    \n    \n 2. Body Mass Index of 17.5 to 30.5 kg/m2; and a total body weight > 50 kg (110 lbs).\n 3. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.\n 4. Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.\n\n","\n\n 1.  Evidence of history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing), cancer, (except for basal cell carcinoma of skin), erythrocytosis, or seizures.\n 2.  Any condition possibly affecting drug absorption (e.g. gastrectomy).\n 3.  History of bleeding ulcer, bleeding abnormalities or coagulation abnormalities.\n 4.  A positive urine drug screen.\n 5.  Use of tobacco or nicotine-containing products within 3 months of Screening or a positive urine cotinine test (ie, active smokers and those who currently use nicotine-containing products are excluded from participation in this study).\n 6.  Significant drug sensitivity or a significant allergic reaction to any drug, as well as known hypersensitivity or idiosyncratic reaction to epoetin (or its excipients, including benzyl alcohol and any other related drugs).\n 7.  Any previous use of epoetin.\n 8.  History of regular alcohol consumption exceeding 7 drinks/week for female subjects or 14 drinks/week for male subjects (1 drink = 5 oz. [150 mL] of wine or as oz. [360 mL] of beer or 1.5 oz. [45 mL] of hard liquor) within 6 months before Screening.\n 9.  Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 half-lives preceeding the fits dose of investigational product (whichever is longer).\n 10. Screening supine BP >= 140 mmHg (systolic) or >=90 mmHg (Diastolic), following at least 5 minutes of supine rest. If BP >= 140 mmHg (systolic) or >= 90 mmHg (Diastolic), the BP should be repeated 2 more times and the average of the 3 BP values should be used to determine the subject's eligibility.\n 11. Screening supine 12-lead ECG demonstrating a corrected QT (QTc) interval> 450 msec or a QRS interval >120 msec. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated 2 more times and the average of the 3 QTc or QRS values should be used to determine the subject's eligibility.\n 12. Subject's with ANY of the following abnormalities in clinical laboratory tests at Screening, as assessed by the study-specific laboratory and confirmed by a single repeat test, if deemed necessary: * Aspartate aminotransferase (AST) OR alanine aminotransferase (ALT) leve l>= 1.5 X upper limit of normal (ULN);\n      * Total bilirubin level 1.5 X ULN; subjects with a history of Gilbert's syndrome may have direct bilirubin measured and would be eligible for this study provided the direct bilirubin level is <= ULN.\n     \n     \n 13. Pregnant female subjects; breastfeeding female subjects; fertile male subjects and female subjects of childbearing potential who are unwilling or unable to use 2 highly effective methods of contraception as outline in the protocol for the duration of the study and for at least 30 days after the last dose of investigational product.\n 14. Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of investigational product. As exceptions, acetaminophen/paracetamol may be used at doses of <= 1 g/day and hormonal contraceptives will be allowed. Limited use of nonprescription medications that are not believed to affect subject safety or the overall results of the study may be permitted on a case-by-case basis following approval by the sponsor.\n 15. A subject who has been administered a drug by depot injection within 30 days prior to the initial study drug administration or 6 half-lives of that drug, whichever is longer and at the discretion of the investigator, or who has received a recent (6 weeks prior to admission to the CRU) live or attenuated vaccination, or exposure to communicable viral diseases such as chicken pox, varicella, and measles.\n 16. Blood donation (excluding plasma donations) or approximately 1 pint (500 mL) or more within 60 days prior to dosing.\n 17. History of HIV, hepatitis B, or hepatitis C, positive testing for HIV, hepatitis B surface antigen (HepBsAg), hepatitis B core antibody (HepBcAb), or hepatitis C antibody (HCVAb).\n 18. Unwilling or unable to comply with the criteria in the Lifestyle Requirements section of the protocol.\n 19. Subjects who are investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.\n 20. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgement of the investigator, would make the subject inappropriate for entry into this study.\n 21. May not be able to comply with the requirements of this clinical trial or be able to communicate effectively with study personnel, or is considered by the investigator, for any reason, to be an unsuitable candidate for the study.","FSH",null,"Protein","Ovary","Actual","2018-01-12","Actual","Anticipated","2018-05-01","Anticipated","2018-01-01","2018-01-08","2018-01-08","2018-01-23","No","Epoetin Hospira\nPharmacokinetics","Interventional","Basic Science","Crossover Assignment","None (Open Label)","Randomized","18 Years","55 Years","All",null,"Yes","No\nInformation relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests",null,"URL: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=C3461009&StudyName=A+Phase+1%2C+Open-label%2C+Randomized%2C+Single+Dose%2C+Crossover+Study+Evaluating+The+Pharmacokinetics+Of+Epoetin+Following+Administration+Of+Epoetin+Hospira+Multiple+Dose+Vial+%28mdv%29+Product+Compared+To+Epoetin+Hospira+Single+Dose+Vial+%28sdv%29+Product+As+Subcutaneous+Injection+To+Normal+Healthy+Subjects [https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=C3461009&StudyName=A+Phase+1%2C+Open-label%2C+Randomized%2C+Single+Dose%2C+Crossover+Study+Evaluating+The+Pharmacokinetics+Of+Epoetin+Following+Administration+Of+Epoetin+Hospira+Multiple+Dose+Vial+%28mdv%29+Product+Compared+To+Epoetin+Hospira+Single+Dose+Vial+%28sdv%29+Product+As+Subcutaneous+Injection+To+Normal+Healthy+Subjects] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To obtain contact information for a study center near you, click here.",null,"Yes","No",{"$nulls":19},"Maximum serum concentration (C max) of PF-06946151 SDV|Maximum serum concentration (C max) of PF-06946151 MDV|Area under the serum PF-06946151 SDV concentration-time profile (AUC last) from time 0 to the last quantifiable concentration (C last)|Area under the serum PF-06946151 MDV concentration-time profile (AUC last) from time 0 to the last quantifiable concentration (C last)|Area under the PF-06946151 SDV concentration-time profile (AUC inf) from time zero extrapolated to infinity|Area under the PF-06946151 MDV concentration-time profile (AUC inf) from time zero extrapolated to infinity",null,"0, 0.5, 3, 6, 9, 12, 15, 24, 30, 36, 48, 72, 96, and 120 hours after dose administration","Time to reach maximum concentration (T max) of PF-06946151 SDV|Time to reach maximum concentration (T max) of PF-06946151 MDV|Elimination half life (T 1/2) of PF-06946151 SDV|Elimination half life (T 1/2) of PF-06946151 MDV|Number of subjects with adverse events (AEs) by severity and relationship to treatment|Number of subjects with abnormal physical exam findings|Percentage of subjects with the development of Anti-Drug Antibodies|Number of subjects with change from baseline in laboratory results|Number of subjects with clinically relevant changes in vital signs since baseline|Percentage of subjects with the development of Neutralizing Antibodies","Day 1 through approximately Day 30 after Period 2","0, 0.5, 3, 6, 9, 12, 15, 24, 30, 36, 48, 72, 96 and 120 hours after dose administration","ClinicalTrials.gov_Inquiries@pfizer.com","Pfizer CT.gov Call Center","1-800-718-1021",{"$nulls":7},"Pfizer CT.gov Call Center","2018-01-23","2020-05-25T16:36:41.072","2020-05-26T17:10:42.972","NCT03398473"]
["5ecbf419307e3d1b1f8d9cd9","NCT03398473","2018-05-17","Pfizer","PFE","Completed","A Study Comparing The Effects Of Epoetin Hospira Single-Dose Vial (SDV) And Multi-Dose Vial (MDV) When Administered Subcutaneously To Normal Healthy Subjects","Epoetin","ESA Activator","Yes","['Epoetin']","No",null,"Phase 1",2,68,"Actual","2018-01-25","2018-04-11","AUC|Clast","Area Under The Curve|Last Quantifiable Plasma Concentration",{"$nulls":3},"This study will assess the PK similarity of epoetin administered as Hospira MDV versus Hospira SDV by conducting a single-dose comparative evaluation in normal healthy subjects enrolled at a single center.",null,"A Phase 1, Open-label, Randomized, Single Dose, Crossover Study Evaluating The Pharmacokinetics Of Epoetin Following Administration Of Epoetin Hospira Multiple Dose Vial (Mdv) Product Compared To Epoetin Hospira Single Dose Vial (Sdv) Product As Subcutaneous Injection To Normal Healthy Subjects","C3461009","Healthy","Healthy Volunteers","Healthy","Healthy","Experimental","Epoetin Hospira SDV|Epoetin Hospira MDV","Epoetin Hospira Single Dose Vial (SDV)|Epoetin Hospira Multi-Dose Vial (MDV)","Drug","Epoetin Hospira SDV|Epoetin Hospira MDV","Epoetin Hospira Single Dose Vial|Epoetin Hospira Multi-Dose Vial",null,"Epoetin Hospira SDV|Epoetin Hospira MDV","\n\n 1. Healthy female and male subjects who, at time of Screening, are between ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination including blood pressure and pulse rate measurement, 12-lead electrocardiogram, or clinical laboratory tests.Female subjects of nonchildbearing potential must meet at least 1 of the following criteria:\n    \n     1. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; a serum follicle-stimulating hormone (FSH) level confirming the postmenopausal state.\n     2. Have undergone a documented hysterectomy and/or bilateral oophorectomy;\n     3. Have medically confirmed ovarian failure.\n    \n    \n 2. Body Mass Index of 17.5 to 30.5 kg/m2; and a total body weight > 50 kg (110 lbs).\n 3. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.\n 4. Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.\n\n","\n\n 1.  Evidence of history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing), cancer, (except for basal cell carcinoma of skin), erythrocytosis, or seizures.\n 2.  Any condition possibly affecting drug absorption (e.g. gastrectomy).\n 3.  History of bleeding ulcer, bleeding abnormalities or coagulation abnormalities.\n 4.  A positive urine drug screen.\n 5.  Use of tobacco or nicotine-containing products within 3 months of Screening or a positive urine cotinine test (ie, active smokers and those who currently use nicotine-containing products are excluded from participation in this study).\n 6.  Significant drug sensitivity or a significant allergic reaction to any drug, as well as known hypersensitivity or idiosyncratic reaction to epoetin (or its excipients, including benzyl alcohol and any other related drugs).\n 7.  Any previous use of epoetin.\n 8.  History of regular alcohol consumption exceeding 7 drinks/week for female subjects or 14 drinks/week for male subjects (1 drink = 5 oz. [150 mL] of wine or as oz. [360 mL] of beer or 1.5 oz. [45 mL] of hard liquor) within 6 months before Screening.\n 9.  Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 half-lives preceeding the fits dose of investigational product (whichever is longer).\n 10. Screening supine BP >= 140 mmHg (systolic) or >=90 mmHg (Diastolic), following at least 5 minutes of supine rest. If BP >= 140 mmHg (systolic) or >= 90 mmHg (Diastolic), the BP should be repeated 2 more times and the average of the 3 BP values should be used to determine the subject's eligibility.\n 11. Screening supine 12-lead ECG demonstrating a corrected QT (QTc) interval> 450 msec or a QRS interval >120 msec. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated 2 more times and the average of the 3 QTc or QRS values should be used to determine the subject's eligibility.\n 12. Subject's with ANY of the following abnormalities in clinical laboratory tests at Screening, as assessed by the study-specific laboratory and confirmed by a single repeat test, if deemed necessary: * Aspartate aminotransferase (AST) OR alanine aminotransferase (ALT) leve l>= 1.5 X upper limit of normal (ULN);\n      * Total bilirubin level 1.5 X ULN; subjects with a history of Gilbert's syndrome may have direct bilirubin measured and would be eligible for this study provided the direct bilirubin level is <= ULN.\n     \n     \n 13. Pregnant female subjects; breastfeeding female subjects; fertile male subjects and female subjects of childbearing potential who are unwilling or unable to use 2 highly effective methods of contraception as outline in the protocol for the duration of the study and for at least 30 days after the last dose of investigational product.\n 14. Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of investigational product. As exceptions, acetaminophen/paracetamol may be used at doses of <= 1 g/day and hormonal contraceptives will be allowed. Limited use of nonprescription medications that are not believed to affect subject safety or the overall results of the study may be permitted on a case-by-case basis following approval by the sponsor.\n 15. A subject who has been administered a drug by depot injection within 30 days prior to the initial study drug administration or 6 half-lives of that drug, whichever is longer and at the discretion of the investigator, or who has received a recent (6 weeks prior to admission to the CRU) live or attenuated vaccination, or exposure to communicable viral diseases such as chicken pox, varicella, and measles.\n 16. Blood donation (excluding plasma donations) or approximately 1 pint (500 mL) or more within 60 days prior to dosing.\n 17. History of HIV, hepatitis B, or hepatitis C, positive testing for HIV, hepatitis B surface antigen (HepBsAg), hepatitis B core antibody (HepBcAb), or hepatitis C antibody (HCVAb).\n 18. Unwilling or unable to comply with the criteria in the Lifestyle Requirements section of the protocol.\n 19. Subjects who are investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.\n 20. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgement of the investigator, would make the subject inappropriate for entry into this study.\n 21. May not be able to comply with the requirements of this clinical trial or be able to communicate effectively with study personnel, or is considered by the investigator, for any reason, to be an unsuitable candidate for the study.","FSH",null,"Protein","Ovary","Actual","2018-01-12","Actual","Actual","2018-05-07","Actual","2018-05-01","2018-01-08","2018-01-08","2018-05-16","No","Epoetin Hospira\nPharmacokinetics","Interventional","Basic Science","Crossover Assignment","None (Open Label)","Randomized","18 Years","55 Years","All",null,"Yes","No\nInformation relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests",null,"URL: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=C3461009&StudyName=A+Phase+1%2C+Open-label%2C+Randomized%2C+Single+Dose%2C+Crossover+Study+Evaluating+The+Pharmacokinetics+Of+Epoetin+Following+Administration+Of+Epoetin+Hospira+Multiple+Dose+Vial+%28mdv%29+Product+Compared+To+Epoetin+Hospira+Single+Dose+Vial+%28sdv%29+Product+As+Subcutaneous+Injection+To+Normal+Healthy+Subjects [https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=C3461009&StudyName=A+Phase+1%2C+Open-label%2C+Randomized%2C+Single+Dose%2C+Crossover+Study+Evaluating+The+Pharmacokinetics+Of+Epoetin+Following+Administration+Of+Epoetin+Hospira+Multiple+Dose+Vial+%28mdv%29+Product+Compared+To+Epoetin+Hospira+Single+Dose+Vial+%28sdv%29+Product+As+Subcutaneous+Injection+To+Normal+Healthy+Subjects] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To obtain contact information for a study center near you, click here.",null,"Yes","No",{"$nulls":19},"Maximum serum concentration (C max) of PF-06946151 SDV|Maximum serum concentration (C max) of PF-06946151 MDV|Area under the serum PF-06946151 SDV concentration-time profile (AUC last) from time 0 to the last quantifiable concentration (C last)|Area under the serum PF-06946151 MDV concentration-time profile (AUC last) from time 0 to the last quantifiable concentration (C last)|Area under the PF-06946151 SDV concentration-time profile (AUC inf) from time zero extrapolated to infinity|Area under the PF-06946151 MDV concentration-time profile (AUC inf) from time zero extrapolated to infinity",null,"0, 0.5, 3, 6, 9, 12, 15, 24, 30, 36, 48, 72, 96, and 120 hours after dose administration","Time to reach maximum concentration (T max) of PF-06946151 SDV|Time to reach maximum concentration (T max) of PF-06946151 MDV|Elimination half life (T 1/2) of PF-06946151 SDV|Elimination half life (T 1/2) of PF-06946151 MDV|Number of subjects with adverse events (AEs) by severity and relationship to treatment|Number of subjects with abnormal physical exam findings|Percentage of subjects with the development of Anti-Drug Antibodies|Number of subjects with change from baseline in laboratory results|Number of subjects with clinically relevant changes in vital signs since baseline|Percentage of subjects with the development of Neutralizing Antibodies","Day 1 through approximately Day 30 after Period 2","0, 0.5, 3, 6, 9, 12, 15, 24, 30, 36, 48, 72, 96 and 120 hours after dose administration",{"$nulls":3},"New Haven, Connecticut, United States, 06511","Connecticut","United States","Pfizer New Haven Clinical Research Unit",{"$nulls":3},"Pfizer CT.gov Call Center","2018-05-16","2020-05-25T16:36:41.719","2020-05-26T17:10:42.972","NCT03398473"]
["5ecbf41c11702c1b1b916a5f","NCT03398837","2018-02-05","Corbus","CRBP","Recruiting","Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis (RESOLVE-1)","Lenabasum","CB2 Agonist","Yes","['Lenabasum']","No",null,"Phase 3",3,354,"Anticipated","2017-12-18","2020-03-01","mRSS","Modified Rodnan Skin Score",{"$nulls":3},"This is a Phase 3 multicenter, double-blind, randomized, placebo-controlled study assessing the efficacy and safety of lenabasum for the treatment of diffuse cutaneous systemic sclerosis (SSc). Approximately 354 subjects will be enrolled in this study at about 60 sites in North America, Europe, Australia, and Asia. The planned duration of treatment with study drug is 52 weeks.",null,"A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis","JBT101-SSc-002","Diffuse Cutaneous Systemic Sclerosis","Scleroderma, General","Connective Tissue Diseases","Derm & Connective Tissue Disorders","Experimental|Placebo Comparator","Cohort 1|Cohort 2|Cohort 3","Lenabasum 5 mg BID|Lenabasum 20 mg BID|Placebo BID","Drug","Lenabasum 5 mg|Lenabasum 20 mg|Placebo oral capsule","Subjects will receive lenabasum 5 mg twice daily.|Subjects will receive lenabasum 20 mg twice daily.|Subjects will receive placebo twice daily.",null,"Cohort 1|Cohort 2|Cohort 3","\n\n 1. â‰¥ 18 years of age at the time Informed Consent is signed.\n 2. Diffuse cutaneous SSc (skin thickening on upper arms, upper legs, or trunk).\n 3. Disease duration â‰¤ 6 years from the first non-Raynaud's symptom.\n 4. No new or increased doses of immunosuppressive medications within 8 weeks prior to Screening.\n\nKey ","\n\n 1. Unstable SSc or SSc with end-stage organ involvement at Screening or Visit 1.\n 2. Any of the following values for laboratory tests at Screening: 1. A positive pregnancy test in women of childbearing potential;\n     2. Hemoglobin < 9 g/dL for males and < 8 g/dL for females;\n     3. Neutrophils < 1.0 Ã—10^9/L;\n     4. Platelets < 75 Ã—10^9/L;\n     5. Creatinine clearance < 50 mL/min according to the Modification of Diet in Renal Disease (MDRD) Study equation;\n     6. Aspartate aminotransferase or alanine aminotransferase > 2.0 Ã— upper limit of normal.\n    \n    \n 3. Any medical condition or concurrent medical therapies at Screening or Visit 1, including a history of non-compliance with medical treatments, that may put the subject at greater safety risk, influence response to study product, or interfere with study assessments.",{"$nulls":4},"Actual","2018-01-16","Actual","Anticipated","2020-03-01","Anticipated","2018-01-01","2018-01-05","2018-01-11","2018-01-31","Yes","Scleroderma\ncannabinoid receptor type 2 agonist\nanabasum\nJBT-101\nlenabasum","Interventional","Treatment","Parallel Assignment","Double (Participant, Investigator)","Randomized","18 Years",null,"All",null,"No","Undecided",{"$nulls":3},"Yes","No",{"$nulls":19},"Efficacy of lenabasum compared to placebo for the change from baseline in modified Rodnan skin score.","mRSS evaluates a subject's skin thickness on a 4 point scale for 17 surface anatomic areas: 0 = normal skin; 1 = mild thickness; 2 = moderate thickness; 3 = severe thickness with inability to pinch skin into fold. The individual values of the 17 surface areas are summed to define the total skin score with a maximum score of 51.","Change from baseline through study completion, up to 1 year.","Efficacy of lenabasum compared to placebo for the change from baseline in Health Assessment Questionnaire - Disability Index.|Efficacy of lenabasum compared to placebo for the American College of Rheumatology Combined Response Index in diffuse cutaneous Systemic Sclerosis score.|Efficacy of lenabasum compared to placebo for the change from baseline in forced vital capacity.","It includes 8 sections: dressing, arising, eating, walking, hygiene, reach, grip, and activities. There are 2 or 3 questions for each section. Scoring within each section is from 0 (without any difficulty) to 3 (unable to do). The individual scores of the eight sections are summed and divided by 8. The result is the disability index or functional disability index. A higher score indicates more functional disability.|The ARC CRISS exponential algorithm determines the predicted probability of improvement from baseline, incorporating change in mRSS, FVC % predicted, physician and patient global assessments, and HAQ-DI. The outcome is a continuous variable between 0.0 and 1.0 (0 - 100%). A higher score indicates greater improvement.|Change from baseline through study completion, up to 1 year.","Change from baseline through study completion, up to 1 year.|American College of Rheumatology Combined Response Index score through study completion, up to 1 year.",{"$nulls":3},"New York, New York, United States, 10065","New York","United States","Hospital For Special Surgery",{"$nulls":4},"2018-01-31","2020-05-25T16:36:44.654","2020-05-26T17:10:42.972","NCT03398837"]
["5ecbf41ce2561b1b11905d4a","NCT03398837","2018-03-15","Corbus","CRBP","Recruiting","Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis (RESOLVE-1)","Lenabasum","CB2 Agonist","Yes","['Lenabasum']","No",null,"Phase 3",3,354,"Anticipated","2017-12-18","2020-03-01","mRSS","Modified Rodnan Skin Score",{"$nulls":3},"This is a Phase 3 multicenter, double-blind, randomized, placebo-controlled study assessing the efficacy and safety of lenabasum for the treatment of diffuse cutaneous systemic sclerosis (SSc). Approximately 354 subjects will be enrolled in this study at about 60 sites in North America, Europe, Australia, and Asia. The planned duration of treatment with study drug is 52 weeks.",null,"A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis","JBT101-SSc-002","Diffuse Cutaneous Systemic Sclerosis","Scleroderma, General","Connective Tissue Diseases","Derm & Connective Tissue Disorders","Experimental|Placebo Comparator","Cohort 1|Cohort 2|Cohort 3","Lenabasum 5 mg BID|Lenabasum 20 mg BID|Placebo BID","Drug","Lenabasum 5 mg|Lenabasum 20 mg|Placebo oral capsule","Subjects will receive lenabasum 5 mg twice daily.|Subjects will receive lenabasum 20 mg twice daily.|Subjects will receive placebo twice daily.",null,"Cohort 1|Cohort 2|Cohort 3","\n\n 1. â‰¥ 18 years of age at the time Informed Consent is signed.\n 2. Diffuse cutaneous SSc (skin thickening on upper arms, upper legs, or trunk).\n 3. Disease duration â‰¤ 6 years from the first non-Raynaud's symptom.\n 4. No new or increased doses of immunosuppressive medications within 8 weeks prior to Screening.\n\nKey ","\n\n 1. Unstable SSc or SSc with end-stage organ involvement at Screening or Visit 1.\n 2. Any of the following values for laboratory tests at Screening: 1. A positive pregnancy test in women of childbearing potential;\n     2. Hemoglobin < 9 g/dL for males and < 8 g/dL for females;\n     3. Neutrophils < 1.0 Ã—10^9/L;\n     4. Platelets < 75 Ã—10^9/L;\n     5. Creatinine clearance < 50 mL/min according to the Modification of Diet in Renal Disease (MDRD) Study equation;\n     6. Aspartate aminotransferase or alanine aminotransferase > 2.0 Ã— upper limit of normal.\n    \n    \n 3. Any medical condition or concurrent medical therapies at Screening or Visit 1, including a history of non-compliance with medical treatments, that may put the subject at greater safety risk, influence response to study product, or interfere with study assessments.",{"$nulls":4},"Actual","2018-01-16","Actual","Anticipated","2020-03-01","Anticipated","2018-03-01","2018-01-05","2018-01-11","2018-03-14","Yes","Scleroderma\ncannabinoid receptor type 2 agonist\nanabasum\nJBT-101\nlenabasum","Interventional","Treatment","Parallel Assignment","Double (Participant, Investigator)","Randomized","18 Years",null,"All",null,"No","Undecided",{"$nulls":3},"Yes","No",{"$nulls":19},"Efficacy of lenabasum compared to placebo for the change from baseline in modified Rodnan skin score.","mRSS evaluates a subject's skin thickness on a 4 point scale for 17 surface anatomic areas: 0 = normal skin; 1 = mild thickness; 2 = moderate thickness; 3 = severe thickness with inability to pinch skin into fold. The individual values of the 17 surface areas are summed to define the total skin score with a maximum score of 51.","Change from baseline through study completion, up to 1 year.","Efficacy of lenabasum compared to placebo for the change from baseline in Health Assessment Questionnaire - Disability Index.|Efficacy of lenabasum compared to placebo for the American College of Rheumatology Combined Response Index in diffuse cutaneous Systemic Sclerosis score.|Efficacy of lenabasum compared to placebo for the change from baseline in forced vital capacity.","It includes 8 sections: dressing, arising, eating, walking, hygiene, reach, grip, and activities. There are 2 or 3 questions for each section. Scoring within each section is from 0 (without any difficulty) to 3 (unable to do). The individual scores of the eight sections are summed and divided by 8. The result is the disability index or functional disability index. A higher score indicates more functional disability.|The ARC CRISS exponential algorithm determines the predicted probability of improvement from baseline, incorporating change in mRSS, FVC % predicted, physician and patient global assessments, and HAQ-DI. The outcome is a continuous variable between 0.0 and 1.0 (0 - 100%). A higher score indicates greater improvement.|Change from baseline through study completion, up to 1 year.","Change from baseline through study completion, up to 1 year.|American College of Rheumatology Combined Response Index score through study completion, up to 1 year.",{"$nulls":3},"Los Angeles, California, United States, 90045|Baltimore, Maryland, United States, 21224|New Brunswick, New Jersey, United States, 08901|New York, New York, United States, 10065","California|Maryland|New Jersey|New York","United States","Pacific Arthritis Care Center|John Hopkins University, Scleroderma Center|Rutgers Clinical Research Center, Robert Wood Johnson Medical School|Hospital For Special Surgery",{"$nulls":4},"2018-03-14","2020-05-25T16:36:44.761","2020-05-26T17:10:42.972","NCT03398837"]
["5ecbf41cfe30261b1a04824f","NCT03398837","2018-05-01","Corbus","CRBP","Recruiting","Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis (RESOLVE-1)","Lenabasum","CB2 Agonist","Yes","['Lenabasum']","No",null,"Phase 3",3,354,"Anticipated","2017-12-18","2020-03-01","mRSS","Modified Rodnan Skin Score",{"$nulls":3},"This is a Phase 3 multicenter, double-blind, randomized, placebo-controlled study assessing the efficacy and safety of lenabasum for the treatment of diffuse cutaneous systemic sclerosis (SSc). Approximately 354 subjects will be enrolled in this study at about 60 sites in North America, Europe, Australia, and Asia. The planned duration of treatment with study drug is 52 weeks.",null,"A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis","JBT101-SSc-002","Diffuse Cutaneous Systemic Sclerosis","Scleroderma, General","Connective Tissue Diseases","Derm & Connective Tissue Disorders","Experimental|Placebo Comparator","Cohort 1|Cohort 2|Cohort 3","Lenabasum 5 mg BID|Lenabasum 20 mg BID|Placebo BID","Drug","Lenabasum 5 mg|Lenabasum 20 mg|Placebo oral capsule","Subjects will receive lenabasum 5 mg twice daily.|Subjects will receive lenabasum 20 mg twice daily.|Subjects will receive placebo twice daily.",null,"Cohort 1|Cohort 2|Cohort 3","\n\n 1. â‰¥ 18 years of age at the time Informed Consent is signed.\n 2. Diffuse cutaneous SSc (skin thickening on upper arms, upper legs, or trunk).\n 3. Disease duration â‰¤ 6 years from the first non-Raynaud's symptom.\n 4. No new or increased doses of immunosuppressive medications within 8 weeks prior to Screening.\n\nKey ","\n\n 1. Unstable SSc or SSc with end-stage organ involvement at Screening or Visit 1.\n 2. Any of the following values for laboratory tests at Screening: 1. A positive pregnancy test in women of childbearing potential;\n     2. Hemoglobin < 9 g/dL for males and < 8 g/dL for females;\n     3. Neutrophils < 1.0 Ã—10^9/L;\n     4. Platelets < 75 Ã—10^9/L;\n     5. Creatinine clearance < 50 mL/min according to the Modification of Diet in Renal Disease (MDRD) Study equation;\n     6. Aspartate aminotransferase or alanine aminotransferase > 2.0 Ã— upper limit of normal.\n    \n    \n 3. Any medical condition or concurrent medical therapies at Screening or Visit 1, including a history of non-compliance with medical treatments, that may put the subject at greater safety risk, influence response to study product, or interfere with study assessments.",{"$nulls":4},"Actual","2018-01-16","Actual","Anticipated","2020-03-01","Anticipated","2018-04-01","2018-01-05","2018-01-11","2018-04-30","Yes","Scleroderma\ncannabinoid receptor type 2 agonist\nanabasum\nJBT-101\nlenabasum","Interventional","Treatment","Parallel Assignment","Double (Participant, Investigator)","Randomized","18 Years",null,"All",null,"No","Undecided",{"$nulls":3},"Yes","No",{"$nulls":19},"Efficacy of lenabasum compared to placebo for the change from baseline in modified Rodnan skin score.","mRSS evaluates a subject's skin thickness on a 4 point scale for 17 surface anatomic areas: 0 = normal skin; 1 = mild thickness; 2 = moderate thickness; 3 = severe thickness with inability to pinch skin into fold. The individual values of the 17 surface areas are summed to define the total skin score with a maximum score of 51.","Change from baseline through study completion, up to 1 year.","Efficacy of lenabasum compared to placebo for the change from baseline in Health Assessment Questionnaire - Disability Index.|Efficacy of lenabasum compared to placebo for the American College of Rheumatology Combined Response Index in diffuse cutaneous Systemic Sclerosis score.|Efficacy of lenabasum compared to placebo for the change from baseline in forced vital capacity.","It includes 8 sections: dressing, arising, eating, walking, hygiene, reach, grip, and activities. There are 2 or 3 questions for each section. Scoring within each section is from 0 (without any difficulty) to 3 (unable to do). The individual scores of the eight sections are summed and divided by 8. The result is the disability index or functional disability index. A higher score indicates more functional disability.|The ARC CRISS exponential algorithm determines the predicted probability of improvement from baseline, incorporating change in mRSS, FVC % predicted, physician and patient global assessments, and HAQ-DI. The outcome is a continuous variable between 0.0 and 1.0 (0 - 100%). A higher score indicates greater improvement.|Change from baseline through study completion, up to 1 year.","Change from baseline through study completion, up to 1 year.|American College of Rheumatology Combined Response Index score through study completion, up to 1 year.",{"$nulls":3},"Los Angeles, California, United States, 90045|Baltimore, Maryland, United States, 21224|Boston, Massachusetts, United States, 02118|New Brunswick, New Jersey, United States, 08901|New York, New York, United States, 10065|Philadelphia, Pennsylvania, United States, 19104","California|Maryland|Massachusetts|New Jersey|New York|Pennsylvania","United States","Pacific Arthritis Care Center|John Hopkins University, Scleroderma Center|Boston University Medical Center (Bumc) - General Clinical Research Unit (Gcru)|Rutgers Clinical Research Center, Robert Wood Johnson Medical School|Hospital For Special Surgery|University Of Pennsylvania Health System - Pcam, Dept. Of Rheumatology",{"$nulls":4},"2018-04-30","2020-05-25T16:36:44.651","2020-05-26T17:10:42.972","NCT03398837"]
["5ecbf41dfeab101b15530881","NCT03398837","2018-08-13","Corbus","CRBP","Recruiting","Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis (RESOLVE-1)","Lenabasum","CB2 Agonist","Yes","['Lenabasum']","No",null,"Phase 3",3,354,"Anticipated","2017-12-18","2020-03-01","mRSS","Modified Rodnan Skin Score",{"$nulls":3},"This is a Phase 3 multicenter, double-blind, randomized, placebo-controlled study assessing the efficacy and safety of lenabasum for the treatment of diffuse cutaneous systemic sclerosis (SSc). Approximately 354 subjects will be enrolled in this study at about 60 sites in North America, Europe, Australia, and Asia. The planned duration of treatment with study drug is 52 weeks.",null,"A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis","JBT101-SSc-002","Diffuse Cutaneous Systemic Sclerosis","Scleroderma, General","Connective Tissue Diseases","Derm & Connective Tissue Disorders","Experimental|Placebo Comparator","Cohort 1|Cohort 2|Cohort 3","Lenabasum 5 mg BID|Lenabasum 20 mg BID|Placebo BID","Drug","Lenabasum 5 mg|Lenabasum 20 mg|Placebo oral capsule","Subjects will receive lenabasum 5 mg twice daily.|Subjects will receive lenabasum 20 mg twice daily.|Subjects will receive placebo twice daily.",null,"Cohort 1|Cohort 2|Cohort 3","\n\n 1. â‰¥ 18 years of age at the time Informed Consent is signed.\n 2. Diffuse cutaneous SSc (skin thickening on upper arms, upper legs, or trunk).\n 3. Disease duration â‰¤ 6 years from the first non-Raynaud's symptom.\n 4. No new or increased doses of immunosuppressive medications within 8 weeks prior to Screening.\n\nKey ","\n\n 1. Unstable SSc or SSc with end-stage organ involvement at Screening or Visit 1.\n 2. Any of the following values for laboratory tests at Screening: 1. A positive pregnancy test in women of childbearing potential;\n     2. Hemoglobin < 9 g/dL for males and < 8 g/dL for females;\n     3. Neutrophils < 1.0 Ã—10^9/L;\n     4. Platelets < 75 Ã—10^9/L;\n     5. Creatinine clearance < 50 mL/min according to the Modification of Diet in Renal Disease (MDRD) Study equation;\n     6. Aspartate aminotransferase or alanine aminotransferase > 2.0 Ã— upper limit of normal.\n    \n    \n 3. Any medical condition or concurrent medical therapies at Screening or Visit 1, including a history of non-compliance with medical treatments, that may put the subject at greater safety risk, influence response to study product, or interfere with study assessments.",{"$nulls":4},"Actual","2018-01-16","Actual","Anticipated","2020-03-01","Anticipated","2018-08-01","2018-01-05","2018-01-11","2018-08-10","Yes","Scleroderma\ncannabinoid receptor type 2 agonist\nanabasum\nJBT-101\nlenabasum","Interventional","Treatment","Parallel Assignment","Double (Participant, Investigator)","Randomized","18 Years",null,"All",null,"No","Undecided",{"$nulls":3},"Yes","No",{"$nulls":19},"Efficacy of lenabasum compared to placebo for the change from baseline in modified Rodnan skin score.","mRSS evaluates a subject's skin thickness on a 4 point scale for 17 surface anatomic areas: 0 = normal skin; 1 = mild thickness; 2 = moderate thickness; 3 = severe thickness with inability to pinch skin into fold. The individual values of the 17 surface areas are summed to define the total skin score with a maximum score of 51.","Change from baseline through study completion, up to 1 year.","Efficacy of lenabasum compared to placebo for the change from baseline in Health Assessment Questionnaire - Disability Index.|Efficacy of lenabasum compared to placebo for the American College of Rheumatology Combined Response Index in diffuse cutaneous Systemic Sclerosis score.|Efficacy of lenabasum compared to placebo for the change from baseline in forced vital capacity.","It includes 8 sections: dressing, arising, eating, walking, hygiene, reach, grip, and activities. There are 2 or 3 questions for each section. Scoring within each section is from 0 (without any difficulty) to 3 (unable to do). The individual scores of the eight sections are summed and divided by 8. The result is the disability index or functional disability index. A higher score indicates more functional disability.|The ARC CRISS exponential algorithm determines the predicted probability of improvement from baseline, incorporating change in mRSS, FVC % predicted, physician and patient global assessments, and HAQ-DI. The outcome is a continuous variable between 0.0 and 1.0 (0 - 100%). A higher score indicates greater improvement.|Change from baseline through study completion, up to 1 year.","Change from baseline through study completion, up to 1 year.|American College of Rheumatology Combined Response Index score through study completion, up to 1 year.",{"$nulls":3},"Sydney, New South Wales, Australia|Adelaide, South|Melbourne, Victoria, Australia, 3065|Winnipeg, Manitoba, Canada|Leiden, South Holland, Netherlands|Dundee, Scotland, United Kingdom, Dd1 9Sy|Salford, United Kingdom, M6 8Hd|Los Angeles, California, United States, 90045|Aurora, Colorado, United States, 80045|Baltimore, Maryland, United States, 21224|Boston, Massachusetts, United States, 02118|Minneapolis, Minnesota, United States, 55455|New Brunswick, New Jersey, United States, 08901|Albany, New York, United States, 12203|Cleveland, Ohio, United States, 44195|Philadelphia, Pennsylvania, United States, 19104|Houston, Texas, United States, 77030|Salt Lake City, Utah, United States, 84132","California|Colorado|Maryland|Massachusetts|Minnesota|New Jersey|New York|Ohio|Pennsylvania|Texas|Utah","Australia|Canada|Netherlands|United Kingdom|United States","New South Wales Royal Prince Alfred Hospital|Royal Adelaide Hospital|Victoria St Vincent's Hospital|Manitoba The Arthritis Centre|South Holland Leiden University Medical Center|, Scotland Ninewells Hospital|Salford Royal Nhs Foundation Trust|Pacific Arthritis Care Center|University Of Colorado Anschutz Medical Campus|John Hopkins University, Scleroderma Center|Boston University Medical Center (Bumc) - General Clinical Research Unit (Gcru)|University Of Minnesota Health Clinical Research Unit|Rutgers Clinical Research Center, Robert Wood Johnson Medical School|The Steffens Scleroderma At The Center For Rheumatology|Cleveland Clinic|University Of Pennsylvania Health System - Pcam, Dept. Of Rheumatology|Utp Rheumatology Clinic|University Of Utah Hospitals And Clinics",{"$nulls":4},"2018-08-10","2020-05-25T16:36:45.151","2020-05-26T17:10:42.972","NCT03398837"]
["5ecbf41d11702c1b1b916a61","NCT03398837","2018-09-27","Corbus","CRBP","Recruiting","Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis (RESOLVE-1)","Lenabasum","CB2 Agonist","Yes","['Lenabasum']","No",null,"Phase 3",3,354,"Anticipated","2017-12-18","2020-03-01","mRSS","Modified Rodnan Skin Score",{"$nulls":3},"This is a Phase 3 multicenter, double-blind, randomized, placebo-controlled study assessing the efficacy and safety of lenabasum for the treatment of diffuse cutaneous systemic sclerosis (SSc). Approximately 354 subjects will be enrolled in this study at about 60 sites in North America, Europe, Australia, and Asia. The planned duration of treatment with study drug is 52 weeks.",null,"A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis","JBT101-SSc-002","Diffuse Cutaneous Systemic Sclerosis","Scleroderma, General","Connective Tissue Diseases","Derm & Connective Tissue Disorders","Experimental|Placebo Comparator","Cohort 1|Cohort 2|Cohort 3","Lenabasum 5 mg BID|Lenabasum 20 mg BID|Placebo BID","Drug","Lenabasum 5 mg|Lenabasum 20 mg|Placebo oral capsule","Subjects will receive lenabasum 5 mg twice daily.|Subjects will receive lenabasum 20 mg twice daily.|Subjects will receive placebo twice daily.",null,"Cohort 1|Cohort 2|Cohort 3","\n\n 1. â‰¥ 18 years of age at the time Informed Consent is signed.\n 2. Diffuse cutaneous SSc (skin thickening on upper arms, upper legs, or trunk).\n 3. Disease duration â‰¤ 6 years from the first non-Raynaud's symptom.\n 4. No new or increased doses of immunosuppressive medications within 8 weeks prior to Screening.\n\nKey ","\n\n 1. Unstable SSc or SSc with end-stage organ involvement at Screening or Visit 1.\n 2. Any of the following values for laboratory tests at Screening: 1. A positive pregnancy test in women of childbearing potential;\n     2. Hemoglobin < 9 g/dL for males and < 8 g/dL for females;\n     3. Neutrophils < 1.0 Ã—10^9/L;\n     4. Platelets < 75 Ã—10^9/L;\n     5. Creatinine clearance < 50 mL/min according to the Modification of Diet in Renal Disease (MDRD) Study equation;\n     6. Aspartate aminotransferase or alanine aminotransferase > 2.0 Ã— upper limit of normal.\n    \n    \n 3. Any medical condition or concurrent medical therapies at Screening or Visit 1, including a history of non-compliance with medical treatments, that may put the subject at greater safety risk, influence response to study product, or interfere with study assessments.",{"$nulls":4},"Actual","2018-01-16","Actual","Anticipated","2020-03-01","Anticipated","2018-09-01","2018-01-05","2018-01-11","2018-09-25","Yes","Scleroderma\ncannabinoid receptor type 2 agonist\nanabasum\nJBT-101\nlenabasum","Interventional","Treatment","Parallel Assignment","Double (Participant, Investigator)","Randomized","18 Years",null,"All",null,"No","Undecided",{"$nulls":3},"Yes","No",{"$nulls":19},"Efficacy of lenabasum compared to placebo for the change from baseline in modified Rodnan skin score.","mRSS evaluates a subject's skin thickness on a 4 point scale for 17 surface anatomic areas: 0 = normal skin; 1 = mild thickness; 2 = moderate thickness; 3 = severe thickness with inability to pinch skin into fold. The individual values of the 17 surface areas are summed to define the total skin score with a maximum score of 51.","Change from baseline through study completion, up to 1 year.","Efficacy of lenabasum compared to placebo for the change from baseline in Health Assessment Questionnaire - Disability Index.|Efficacy of lenabasum compared to placebo for the American College of Rheumatology Combined Response Index in diffuse cutaneous Systemic Sclerosis score.|Efficacy of lenabasum compared to placebo for the change from baseline in forced vital capacity.","It includes 8 sections: dressing, arising, eating, walking, hygiene, reach, grip, and activities. There are 2 or 3 questions for each section. Scoring within each section is from 0 (without any difficulty) to 3 (unable to do). The individual scores of the eight sections are summed and divided by 8. The result is the disability index or functional disability index. A higher score indicates more functional disability.|The ARC CRISS exponential algorithm determines the predicted probability of improvement from baseline, incorporating change in mRSS, FVC % predicted, physician and patient global assessments, and HAQ-DI. The outcome is a continuous variable between 0.0 and 1.0 (0 - 100%). A higher score indicates greater improvement.|Change from baseline through study completion, up to 1 year.","Change from baseline through study completion, up to 1 year.|American College of Rheumatology Combined Response Index score through study completion, up to 1 year.",{"$nulls":3},"Adelaide, Australia, 5000|MontrÃ©al, Canada|Heidelberg, Baden-WÃ¼rttemberg, Germany, 69120|Haifa, Israel, 3109601|BunkyÅ\u008d-Ku, Tokyo, Japan, 113-8603|Leiden, South Holland, Netherlands|Dundee, Scotland, United Kingdom, Dd1 9Sy|Newcastle, Tyne And Wear, United Kingdom, Ne7 7Dn|Dudley, West Midlands, United Kingdom, Dy1 2Hq|London, United Kingdom, Nw3 2Qg|Los Angeles, California, United States, 90045|Aurora, Colorado, United States, 80045|New Orleans, Louisiana, United States, 70112|Baltimore, Maryland, United States, 21224|Boston, Massachusetts, United States, 02114|Minneapolis, Minnesota, United States, 55455|New Brunswick, New Jersey, United States, 08901|Albany, New York, United States, 12203|Cleveland, Ohio, United States, 44195|Philadelphia, Pennsylvania, United States, 19104|Dallas, Texas, United States, 75231|Salt Lake City, Utah, United States, 84132","California|Colorado|Louisiana|Maryland|Massachusetts|Minnesota|New Jersey|New York|Ohio|Pennsylvania|Texas|Utah","Australia|Canada|Germany|Israel|Japan|Netherlands|United Kingdom|United States","Royal Adelaide Hospital|Sir Mortimer B. Davis Jewish General Hospital|Baden-WÃ¼rttemberg UniversitÃ¤tsklinikum Heidelberg|Rambam Health Corporation|Tokyo Nippon Medical School Hospital|South Holland Leiden University Medical Center|, Scotland Ninewells Hospital|, Tyne And Wear Freeman Hospital|, West Midlands Russell's Hall Hospital|Royal Free Hospital London Nhs Foundation Trust|Pacific Arthritis Care Center|University Of Colorado Anschutz Medical Campus|Tulane University Medical Center|John Hopkins University, Scleroderma Center|Massachusetts General Hospital, Division Of Rheumatology|University Of Minnesota Health Clinical Research Unit|Rutgers Clinical Research Center, Robert Wood Johnson Medical School|The Steffens Scleroderma At The Center For Rheumatology|Cleveland Clinic|University Of Pennsylvania Health System - Pcam, Dept. Of Rheumatology|Metroplex Clinical Research Center|University Of Utah Hospitals And Clinics",{"$nulls":4},"2018-09-25","2020-05-25T16:36:45.132","2020-05-26T17:10:42.972","NCT03398837"]
["5ecbf41d307e3d1b1f8d9ce1","NCT03398837","2018-11-08","Corbus","CRBP","Recruiting","Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis (RESOLVE-1)","Lenabasum","CB2 Agonist","Yes","['Lenabasum']","No",null,"Phase 3",3,354,"Anticipated","2017-12-18","2020-03-01","mRSS","Modified Rodnan Skin Score",{"$nulls":3},"This is a Phase 3 multicenter, double-blind, randomized, placebo-controlled study assessing the efficacy and safety of lenabasum for the treatment of diffuse cutaneous systemic sclerosis (SSc). Approximately 354 subjects will be enrolled in this study at about 60 sites in North America, Europe, Australia, and Asia. The planned duration of treatment with study drug is 52 weeks.",null,"A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis","JBT101-SSc-002","Diffuse Cutaneous Systemic Sclerosis","Scleroderma, General","Connective Tissue Diseases","Derm & Connective Tissue Disorders","Experimental|Placebo Comparator","Cohort 1|Cohort 2|Cohort 3","Lenabasum 5 mg BID|Lenabasum 20 mg BID|Placebo BID","Drug","Lenabasum 5 mg|Lenabasum 20 mg|Placebo oral capsule","Subjects will receive lenabasum 5 mg twice daily.|Subjects will receive lenabasum 20 mg twice daily.|Subjects will receive placebo twice daily.",null,"Cohort 1|Cohort 2|Cohort 3","\n\n 1. â‰¥ 18 years of age at the time Informed Consent is signed.\n 2. Diffuse cutaneous SSc (skin thickening on upper arms, upper legs, or trunk).\n 3. Disease duration â‰¤ 6 years from the first non-Raynaud's symptom.\n 4. No new or increased doses of immunosuppressive medications within 8 weeks prior to Screening.\n\nKey ","\n\n 1. Unstable SSc or SSc with end-stage organ involvement at Screening or Visit 1.\n 2. Any of the following values for laboratory tests at Screening: 1. A positive pregnancy test in women of childbearing potential;\n     2. Hemoglobin < 9 g/dL for males and < 8 g/dL for females;\n     3. Neutrophils < 1.0 Ã—10^9/L;\n     4. Platelets < 75 Ã—10^9/L;\n     5. Creatinine clearance < 50 mL/min according to the Modification of Diet in Renal Disease (MDRD) Study equation;\n     6. Aspartate aminotransferase or alanine aminotransferase > 2.0 Ã— upper limit of normal.\n    \n    \n 3. Any medical condition or concurrent medical therapies at Screening or Visit 1, including a history of non-compliance with medical treatments, that may put the subject at greater safety risk, influence response to study product, or interfere with study assessments.",{"$nulls":4},"Actual","2018-01-16","Actual","Anticipated","2020-03-01","Anticipated","2018-11-01","2018-01-05","2018-01-11","2018-11-07","Yes","Scleroderma\ncannabinoid receptor type 2 agonist\nanabasum\nJBT-101\nlenabasum","Interventional","Treatment","Parallel Assignment","Double (Participant, Investigator)","Randomized","18 Years",null,"All",null,"No","Undecided",{"$nulls":3},"Yes","No",{"$nulls":19},"Efficacy of lenabasum compared to placebo for the change from baseline in modified Rodnan skin score.","mRSS evaluates a subject's skin thickness on a 4 point scale for 17 surface anatomic areas: 0 = normal skin; 1 = mild thickness; 2 = moderate thickness; 3 = severe thickness with inability to pinch skin into fold. The individual values of the 17 surface areas are summed to define the total skin score with a maximum score of 51.","Change from baseline through study completion, up to 1 year.","Efficacy of lenabasum compared to placebo for the change from baseline in Health Assessment Questionnaire - Disability Index.|Efficacy of lenabasum compared to placebo for the American College of Rheumatology Combined Response Index in diffuse cutaneous Systemic Sclerosis score.|Efficacy of lenabasum compared to placebo for the change from baseline in forced vital capacity.","It includes 8 sections: dressing, arising, eating, walking, hygiene, reach, grip, and activities. There are 2 or 3 questions for each section. Scoring within each section is from 0 (without any difficulty) to 3 (unable to do). The individual scores of the eight sections are summed and divided by 8. The result is the disability index or functional disability index. A higher score indicates more functional disability.|The ARC CRISS exponential algorithm determines the predicted probability of improvement from baseline, incorporating change in mRSS, FVC % predicted, physician and patient global assessments, and HAQ-DI. The outcome is a continuous variable between 0.0 and 1.0 (0 - 100%). A higher score indicates greater improvement.|Change from baseline through study completion, up to 1 year.","Change from baseline through study completion, up to 1 year.|American College of Rheumatology Combined Response Index score through study completion, up to 1 year.",{"$nulls":3},"Adelaide, Australia, 5000|MontrÃ©al, Canada|Heidelberg, Baden-WÃ¼rttemberg, Germany, 69120|Ulm, Germany|Haifa, Israel, 3109601|Maebashi, Japan|BunkyÅ\u008d-Ku, Tokyo, Japan, 113-8603|Leiden, South Holland, Netherlands|Barcelona, Spain|Dundee, Scotland, United Kingdom, Dd1 9Sy|Newcastle, Tyne And Wear, United Kingdom, Ne7 7Dn|Dudley, West Midlands, United Kingdom, Dy1 2Hq|London, United Kingdom, Nw3 2Qg|Los Angeles, California, United States, 90045|Aurora, Colorado, United States, 80045|New Orleans, Louisiana, United States, 70112|Baltimore, Maryland, United States, 21224|Boston, Massachusetts, United States, 02114|Ann Arbor, Michigan, United States, 48109|Minneapolis, Minnesota, United States, 55455|New Brunswick, New Jersey, United States, 08901|Albany, New York, United States, 12203|Cleveland, Ohio, United States, 44195|Philadelphia, Pennsylvania, United States, 19104|Dallas, Texas, United States, 75231|Salt Lake City, Utah, United States, 84132","California|Colorado|Louisiana|Maryland|Massachusetts|Michigan|Minnesota|New Jersey|New York|Ohio|Pennsylvania|Texas|Utah","Australia|Canada|Germany|Israel|Japan|Netherlands|Spain|United Kingdom|United States","Royal Adelaide Hospital|Sir Mortimer B. Davis Jewish General Hospital|Baden-WÃ¼rttemberg UniversitÃ¤tsklinikum Heidelberg|University Hospital Ulm|Rambam Health Corporation|Gunma University Hospital|Tokyo Nippon Medical School Hospital|South Holland Leiden University Medical Center|Hospital Universitari De La Santa Creu I Sant Pau|, Scotland Ninewells Hospital|, Tyne And Wear Freeman Hospital|, West Midlands Russell's Hall Hospital|Royal Free Hospital London Nhs Foundation Trust|Pacific Arthritis Care Center|University Of Colorado Anschutz Medical Campus|Tulane University Medical Center|John Hopkins University, Scleroderma Center|Massachusetts General Hospital, Division Of Rheumatology|Michigan Medicine|University Of Minnesota Health Clinical Research Unit|Rutgers Clinical Research Center, Robert Wood Johnson Medical School|The Steffens Scleroderma At The Center For Rheumatology|Cleveland Clinic|University Of Pennsylvania Health System - Pcam, Dept. Of Rheumatology|Metroplex Clinical Research Center|University Of Utah Hospitals And Clinics",{"$nulls":4},"2018-11-07","2020-05-25T16:36:45.147","2020-05-26T17:10:42.972","NCT03398837"]
["5ecbf41de2561b1b11905d4c","NCT03398837","2018-11-27","Corbus","CRBP","Recruiting","Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis (RESOLVE-1)","Lenabasum","CB2 Agonist","Yes","['Lenabasum']","No",null,"Phase 3",3,354,"Anticipated","2017-12-18","2020-03-01","mRSS","Modified Rodnan Skin Score",{"$nulls":3},"This is a Phase 3 multicenter, double-blind, randomized, placebo-controlled study assessing the efficacy and safety of lenabasum for the treatment of diffuse cutaneous systemic sclerosis (SSc). Approximately 354 subjects will be enrolled in this study at about 60 sites in North America, Europe, Australia, and Asia. The planned duration of treatment with study drug is 52 weeks.",null,"A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis","JBT101-SSc-002","Diffuse Cutaneous Systemic Sclerosis","Scleroderma, General","Connective Tissue Diseases","Derm & Connective Tissue Disorders","Experimental|Placebo Comparator","Cohort 1|Cohort 2|Cohort 3","Lenabasum 5 mg BID|Lenabasum 20 mg BID|Placebo BID","Drug","Lenabasum 5 mg|Lenabasum 20 mg|Placebo oral capsule","Subjects will receive lenabasum 5 mg twice daily.|Subjects will receive lenabasum 20 mg twice daily.|Subjects will receive placebo twice daily.",null,"Cohort 1|Cohort 2|Cohort 3","\n\n 1. â‰¥ 18 years of age at the time Informed Consent is signed.\n 2. Diffuse cutaneous SSc (skin thickening on upper arms, upper legs, or trunk).\n 3. Disease duration â‰¤ 6 years from the first non-Raynaud's symptom.\n 4. No new or increased doses of immunosuppressive medications within 8 weeks prior to Screening.\n\nKey ","\n\n 1. Unstable SSc or SSc with end-stage organ involvement at Screening or Visit 1.\n 2. Any of the following values for laboratory tests at Screening: 1. A positive pregnancy test in women of childbearing potential;\n     2. Hemoglobin < 9 g/dL for males and < 8 g/dL for females;\n     3. Neutrophils < 1.0 Ã—10^9/L;\n     4. Platelets < 75 Ã—10^9/L;\n     5. Creatinine clearance < 50 mL/min according to the Modification of Diet in Renal Disease (MDRD) Study equation;\n     6. Aspartate aminotransferase or alanine aminotransferase > 2.0 Ã— upper limit of normal.\n    \n    \n 3. Any medical condition or concurrent medical therapies at Screening or Visit 1, including a history of non-compliance with medical treatments, that may put the subject at greater safety risk, influence response to study product, or interfere with study assessments.",{"$nulls":4},"Actual","2018-01-16","Actual","Anticipated","2020-03-01","Anticipated","2018-11-01","2018-01-05","2018-01-11","2018-11-26","Yes","Scleroderma\ncannabinoid receptor type 2 agonist\nanabasum\nJBT-101\nlenabasum","Interventional","Treatment","Parallel Assignment","Double (Participant, Investigator)","Randomized","18 Years",null,"All",null,"No","Undecided",{"$nulls":3},"Yes","No",{"$nulls":19},"Efficacy of lenabasum compared to placebo for the change from baseline in modified Rodnan skin score.","mRSS evaluates a subject's skin thickness on a 4 point scale for 17 surface anatomic areas: 0 = normal skin; 1 = mild thickness; 2 = moderate thickness; 3 = severe thickness with inability to pinch skin into fold. The individual values of the 17 surface areas are summed to define the total skin score with a maximum score of 51.","Change from baseline through study completion, up to 1 year.","Efficacy of lenabasum compared to placebo for the change from baseline in Health Assessment Questionnaire - Disability Index.|Efficacy of lenabasum compared to placebo for the American College of Rheumatology Combined Response Index in diffuse cutaneous Systemic Sclerosis score.|Efficacy of lenabasum compared to placebo for the change from baseline in forced vital capacity.","It includes 8 sections: dressing, arising, eating, walking, hygiene, reach, grip, and activities. There are 2 or 3 questions for each section. Scoring within each section is from 0 (without any difficulty) to 3 (unable to do). The individual scores of the eight sections are summed and divided by 8. The result is the disability index or functional disability index. A higher score indicates more functional disability.|The ARC CRISS exponential algorithm determines the predicted probability of improvement from baseline, incorporating change in mRSS, FVC % predicted, physician and patient global assessments, and HAQ-DI. The outcome is a continuous variable between 0.0 and 1.0 (0 - 100%). A higher score indicates greater improvement.|Change from baseline through study completion, up to 1 year.","Change from baseline through study completion, up to 1 year.|American College of Rheumatology Combined Response Index score through study completion, up to 1 year.",{"$nulls":3},"Adelaide, Australia, 5000|MontrÃ©al, Canada|Heidelberg, Baden-WÃ¼rttemberg, Germany, 69120|Freiburg, Germany|Haifa, Israel, 3109601|Maebashi, Japan Yokohama City University HospitalYokohama, Japan Korea, Republic Of Seoul National University HospitalSeoul, Korea, Republic Of, 03080|BunkyÅ\u008d-Ku, Tokyo, Japan|Rotterdam, Netherlands|Leiden, South Holland, Netherlands|Barcelona, Spain|Saint Gallen, Switzerland|Dundee, Scotland, United Kingdom, Dd1 9Sy|Newcastle, Tyne And Wear, United Kingdom, Ne7 7Dn|Dudley, West Midlands, United Kingdom, Dy1 2Hq|London, United Kingdom, Nw3 2Qg|La Jolla, California, United States, 92037|Aurora, Colorado, United States, 80045|New Orleans, Louisiana, United States, 70112|Baltimore, Maryland, United States, 21224|Boston, Massachusetts, United States, 02114|Ann Arbor, Michigan, United States, 48109|Minneapolis, Minnesota, United States, 55455|New Brunswick, New Jersey, United States, 08901|Albany, New York, United States, 12203|Cleveland, Ohio, United States, 44195|Philadelphia, Pennsylvania, United States, 19104|Charleston, South Carolina, United States, 29425|Dallas, Texas, United States, 75231|Salt Lake City, Utah, United States, 84132","California|Colorado|Louisiana|Maryland|Massachusetts|Michigan|Minnesota|New Jersey|New York|Ohio|Pennsylvania|South Carolina|Texas|Utah","Australia|Canada|Germany|Israel|Japan|Netherlands|Spain|Switzerland|United Kingdom|United States","Royal Adelaide Hospital|Sir Mortimer B. Davis Jewish General Hospital|Baden-WÃ¼rttemberg UniversitÃ¤tsklinikum Heidelberg|University Medical Center Freiburg|Rambam Health Corporation|Gunma University Hospital|Tokyo Nippon Medical School Hospital|Erasmus Medical Center|South Holland Leiden University Medical Center|Hospital Universitari De La Santa Creu I Sant Pau|Cantonal Hospital St. Gallen|, Scotland Ninewells Hospital|, Tyne And Wear Freeman Hospital|, West Midlands Russell's Hall Hospital|Royal Free Hospital London Nhs Foundation Trust|University Of California San Diego|University Of Colorado Anschutz Medical Campus|Tulane University Medical Center|John Hopkins University, Scleroderma Center|Massachusetts General Hospital, Division Of Rheumatology|Michigan Medicine|University Of Minnesota Health Clinical Research Unit|Rutgers Clinical Research Center, Robert Wood Johnson Medical School|The Steffens Scleroderma At The Center For Rheumatology|Cleveland Clinic|University Of Pennsylvania Health System - Pcam, Dept. Of Rheumatology|Medical University Of South Carolina|Metroplex Clinical Research Center|University Of Utah Hospitals And Clinics",{"$nulls":4},"2018-11-26","2020-05-25T16:36:45.382","2020-05-26T17:10:42.972","NCT03398837"]
["5ecbf41dfeab101b15530882","NCT03398837","2019-02-22","Corbus","CRBP","Recruiting","Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis (RESOLVE-1)","Lenabasum","CB2 Agonist","Yes","['Lenabasum']","No",null,"Phase 3",3,354,"Anticipated","2017-12-18","2020-03-01","mRSS","Modified Rodnan Skin Score",{"$nulls":3},"This is a Phase 3 multicenter, double-blind, randomized, placebo-controlled study assessing the efficacy and safety of lenabasum for the treatment of diffuse cutaneous systemic sclerosis (SSc). Approximately 354 subjects will be enrolled in this study at about 60 sites in North America, Europe, Australia, and Asia. The planned duration of treatment with study drug is 52 weeks.",null,"A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis","JBT101-SSc-002","Diffuse Cutaneous Systemic Sclerosis","Scleroderma, General","Connective Tissue Diseases","Derm & Connective Tissue Disorders","Experimental|Placebo Comparator","Cohort 1|Cohort 2|Cohort 3","Lenabasum 5 mg BID|Lenabasum 20 mg BID|Placebo BID","Drug","Lenabasum 5 mg|Lenabasum 20 mg|Placebo oral capsule","Subjects will receive lenabasum 5 mg twice daily.|Subjects will receive lenabasum 20 mg twice daily.|Subjects will receive placebo twice daily.",null,"Cohort 1|Cohort 2|Cohort 3","\n\n 1. â‰¥ 18 years of age at the time Informed Consent is signed.\n 2. Diffuse cutaneous SSc (skin thickening on upper arms, upper legs, or trunk).\n 3. Disease duration â‰¤ 6 years from the first non-Raynaud's symptom.\n 4. No new or increased doses of immunosuppressive medications within 8 weeks prior to Screening.\n\nKey ","\n\n 1. Unstable SSc or SSc with end-stage organ involvement at Screening or Visit 1.\n 2. Any of the following values for laboratory tests at Screening: 1. A positive pregnancy test in women of childbearing potential;\n     2. Hemoglobin < 9 g/dL for males and < 8 g/dL for females;\n     3. Neutrophils < 1.0 Ã—10^9/L;\n     4. Platelets < 75 Ã—10^9/L;\n     5. Creatinine clearance < 50 mL/min according to the Modification of Diet in Renal Disease (MDRD) Study equation;\n     6. Aspartate aminotransferase or alanine aminotransferase > 2.0 Ã— upper limit of normal.\n    \n    \n 3. Any medical condition or concurrent medical therapies at Screening or Visit 1, including a history of non-compliance with medical treatments, that may put the subject at greater safety risk, influence response to study product, or interfere with study assessments.",{"$nulls":4},"Actual","2018-01-16","Actual","Anticipated","2020-03-01","Anticipated","2019-02-01","2018-01-05","2018-01-11","2019-02-21","Yes","Scleroderma\ncannabinoid receptor type 2 agonist\nanabasum\nJBT-101\nlenabasum","Interventional","Treatment","Parallel Assignment","Double (Participant, Investigator)","Randomized","18 Years",null,"All",null,"No","Undecided",{"$nulls":3},"Yes","No",{"$nulls":19},"Efficacy of lenabasum compared to placebo for the change from baseline in modified Rodnan skin score.","mRSS evaluates a subject's skin thickness on a 4 point scale for 17 surface anatomic areas: 0 = normal skin; 1 = mild thickness; 2 = moderate thickness; 3 = severe thickness with inability to pinch skin into fold. The individual values of the 17 surface areas are summed to define the total skin score with a maximum score of 51.","Change from baseline through study completion, up to 1 year.","Efficacy of lenabasum compared to placebo for the change from baseline in Health Assessment Questionnaire - Disability Index.|Efficacy of lenabasum compared to placebo for the American College of Rheumatology Combined Response Index in diffuse cutaneous Systemic Sclerosis score.|Efficacy of lenabasum compared to placebo for the change from baseline in forced vital capacity.","It includes 8 sections: dressing, arising, eating, walking, hygiene, reach, grip, and activities. There are 2 or 3 questions for each section. Scoring within each section is from 0 (without any difficulty) to 3 (unable to do). The individual scores of the eight sections are summed and divided by 8. The result is the disability index or functional disability index. A higher score indicates more functional disability.|The ARC CRISS exponential algorithm determines the predicted probability of improvement from baseline, incorporating change in mRSS, FVC % predicted, physician and patient global assessments, and HAQ-DI. The outcome is a continuous variable between 0.0 and 1.0 (0 - 100%). A higher score indicates greater improvement.|Change from baseline through study completion, up to 1 year.","Change from baseline through study completion, up to 1 year.|American College of Rheumatology Combined Response Index score through study completion, up to 1 year.",{"$nulls":3},"Adelaide, Australia, 5000|MontrÃ©al, Canada|Heidelberg, Baden-WÃ¼rttemberg, Germany, 69120|Berlin, Germany|Haifa, Israel, 3109601|Fukuoka, Japan Kanazawa University HospitalKanazawa, Japan Gunma University HospitalMaebashi, Japan Hokkaido University HospitalSapporo, Japan National University Corporation Tohoku University Tohoku University HospitalSendai, Japan Osaka University HospitalSuita, Japan Nippon Medical School HospitalTokyo, Japan Yokohama City University HospitalYokohama, Japan Korea, Republic Of Seoul National University HospitalSeoul, Korea, Republic Of, 03080|Rotterdam, Netherlands|Leiden, South Holland, Netherlands|Lublin, Poland|Barcelona, Spain|Saint Gallen, Switzerland|Dundee, Scotland, United Kingdom, Dd1 9Sy|Newcastle, Tyne And Wear, United Kingdom, Ne7 7Dn|Dudley, West Midlands, United Kingdom, Dy1 2Hq|Leeds, United Kingdom|La Jolla, California, United States, 92037|Aurora, Colorado, United States, 80045|Chicago, Illinois, United States, 60611|New Orleans, Louisiana, United States, 70112|Baltimore, Maryland, United States, 21224|Boston, Massachusetts, United States, 02114|Ann Arbor, Michigan, United States, 48109|Minneapolis, Minnesota, United States, 55455|New Brunswick, New Jersey, United States, 08901|[Active, Not Recruiting]Albany, New York, United States, 12203 Columbia University Medical CenterNew York, New York, United States, 10032|Cleveland, Ohio, United States, 44195|Philadelphia, Pennsylvania, United States, 19104|Charleston, South Carolina, United States, 29425|Dallas, Texas, United States, 75231|Salt Lake City, Utah, United States, 84132|Milwaukee, Wisconsin, United States, 53226","California|Colorado|Illinois|Louisiana|Maryland|Massachusetts|Michigan|Minnesota|New Jersey|New York|Ohio|Pennsylvania|South Carolina|Texas|Utah|Wisconsin","Australia|Canada|Germany|Israel|Japan|Netherlands|Poland|Spain|Switzerland|United Kingdom|United States","Royal Adelaide Hospital|Sir Mortimer B. Davis Jewish General Hospital|Baden-WÃ¼rttemberg UniversitÃ¤tsklinikum Heidelberg|CharitÃ©- UniversitÃ¤tsmedizin Berlin, Klinik FÃ¼r Rheumatologie Und Klinische Immunologie, Abteilung -Neue Therapien & Studien-|Rambam Health Corporation|Kyushu University Hospital|Erasmus Medical Center|South Holland Leiden University Medical Center|Samodzielny Publiczny Szpital Kliniczny Nr 1; Katedra I Klinika Dermatologii, Wenerologii I Dermatologii DzieciÄ™cej Uniwersytetu Medycznego W Lublinie|Hospital Universitari De La Santa Creu I Sant Pau|Cantonal Hospital St. Gallen|, Scotland Ninewells Hospital|, Tyne And Wear Freeman Hospital|, West Midlands Russell's Hall Hospital|Leeds Institute Of Rheumatic And Musculoskeletal Medicine (Lirmm)|University Of California San Diego|University Of Colorado Anschutz Medical Campus|Northwestern University|Tulane University Medical Center|John Hopkins University, Scleroderma Center|Massachusetts General Hospital, Division Of Rheumatology|Michigan Medicine|University Of Minnesota Health Clinical Research Unit|Rutgers Clinical Research Center, Robert Wood Johnson Medical School|The Steffens Scleroderma At The Center For Rheumatology|Cleveland Clinic|University Of Pennsylvania Health System - Pcam, Dept. Of Rheumatology|Medical University Of South Carolina|Metroplex Clinical Research Center|University Of Utah Hospitals And Clinics|Medical College Of Wisconsin/Froedtert Hospital",{"$nulls":4},"2019-02-21","2020-05-25T16:36:45.759","2020-05-26T17:10:42.972","NCT03398837"]
["5ecbf41de2561b1b11905d4d","NCT03398837","2020-01-13","Corbus","CRBP","Active, not recruiting","Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis (RESOLVE-1)","Lenabasum","CB2 Agonist","Yes","['Lenabasum']","No",null,"Phase 3",3,365,"Actual","2017-12-18","2020-03-01",{"$nulls":5},"This is a Phase 3 multicenter, double-blind, randomized, placebo-controlled study assessing the efficacy and safety of lenabasum for the treatment of diffuse cutaneous systemic sclerosis (SSc). Approximately 354 subjects will be enrolled in this study at about 60 sites in North America, Europe, Australia, and Asia. The planned duration of treatment with study drug is 52 weeks.",null,"A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis","JBT101-SSc-002","Diffuse Cutaneous Systemic Sclerosis","Scleroderma, General","Connective Tissue Diseases","Derm & Connective Tissue Disorders","Experimental|Placebo Comparator","Cohort 1|Cohort 2|Cohort 3","Lenabasum 5 mg BID|Lenabasum 20 mg BID|Placebo BID","Drug","Lenabasum 5 mg|Lenabasum 20 mg|Placebo oral capsule","Subjects will receive lenabasum 5 mg twice daily.|Subjects will receive lenabasum 20 mg twice daily.|Subjects will receive placebo twice daily.",null,"Cohort 1|Cohort 2|Cohort 3","\n\n 1. â‰¥ 18 years of age at the time Informed Consent is signed.\n 2. Diffuse cutaneous SSc (skin thickening on upper arms, upper legs, or trunk).\n 3. Disease duration â‰¤ 6 years from the first non-Raynaud's symptom.\n 4. No new or increased doses of immunosuppressive medications within 8 weeks prior to Screening.\n\nKey ","\n\n 1. Unstable SSc or SSc with end-stage organ involvement at Screening or Visit 1.\n 2. Any of the following values for laboratory tests at Screening: 1. A positive pregnancy test in women of childbearing potential;\n     2. Hemoglobin < 9 g/dL for males and < 8 g/dL for females;\n     3. Neutrophils < 1.0 Ã—10^9/L;\n     4. Platelets < 75 Ã—10^9/L;\n     5. Creatinine clearance < 50 mL/min according to the Modification of Diet in Renal Disease (MDRD) Study equation;\n     6. Aspartate aminotransferase or alanine aminotransferase > 2.0 Ã— upper limit of normal.\n    \n    \n 3. Any medical condition or concurrent medical therapies at Screening or Visit 1, including a history of non-compliance with medical treatments, that may put the subject at greater safety risk, influence response to study product, or interfere with study assessments.",{"$nulls":4},"Actual","2018-01-16","Actual","Anticipated","2020-03-01","Anticipated","2020-01-01","2018-01-05","2018-01-11","2020-01-08","Yes","Scleroderma\ncannabinoid receptor type 2 agonist\nanabasum\nJBT-101\nlenabasum","Interventional","Treatment","Parallel Assignment","Double (Participant, Investigator)","Randomized","18 Years",null,"All",null,"No","Undecided",{"$nulls":3},"Yes","No",{"$nulls":19},"Efficacy of lenabasum compared to placebo for the American College of Rheumatology Combined Response Index in diffuse cutaneous Systemic Sclerosis score.","The ACR CRISS exponential algorithm determines the predicted probability of improvement from baseline, incorporating change in mRSS, FVC % predicted, physician and patient global assessments, and HAQ-DI. The outcome is a continuous variable between 0.0 and 1.0 (0 - 100%). A higher score indicates greater improvement.","American College of Rheumatology Combined Response Index score through study completion, up to 1 year.","Efficacy of lenabasum compared to placebo for the change from baseline in modified Rodnan skin score.|Efficacy of lenabasum compared to placebo for the change from baseline in Health Assessment Questionnaire - Disability Index.|Efficacy of lenabasum compared to placebo for the change from baseline in forced vital capacity.","mRSS evaluates a subject's skin thickness on a 4 point scale for 17 surface anatomic areas: 0 = normal skin; 1 = mild thickness; 2 = moderate thickness; 3 = severe thickness with inability to pinch skin into fold. The individual values of the 17 surface areas are summed to define the total skin score with a maximum score of 51.|It includes 8 sections: dressing, arising, eating, walking, hygiene, reach, grip, and activities. There are 2 or 3 questions for each section. Scoring within each section is from 0 (without any difficulty) to 3 (unable to do). The individual scores of the eight sections are summed and divided by 8. The result is the disability index or functional disability index. A higher score indicates more functional disability.|Change from baseline through study completion, up to 1 year.","Change from baseline through study completion, up to 1 year.",{"$nulls":3},"Adelaide, Australia, 5000 Liverpool HospitalLiverpool, Australia St Vincent'S HospitalMelbourne, Australia, 3065 Royal Prince Alfred HospitalSydney, Australia|MontrÃ©al, Canada The Arthritis CentreWinnipeg, Canada|Heidelberg, Baden-WÃ¼rttemberg, Germany, 69120|Berlin, Germany University Hospital Cologne, Department Of Dermatology And VenereologyCologne, Germany Department Of Internal Medicine 3, University Of Erlangen-NurembergErlangen, Germany University Medical Center FreiburgFreiburg, Germany UniversitÃ¤tsklinik KÃ¶ln,Klinik Und Poliklinik FÃ¼r Dermatologie Und VenerologieKÃ¶ln, Germany Kerckhoff-Klinik Gmbh, Zentrum Rheumatologie U. Klin. Immunologie, StudienambulanzNauheim, Germany University Hospital UlmUlm, Germany|Haifa, Israel, 3109601 Bnai Zion Medical CenterHaifa, Israel Meir Medical Center - Internal Medicine EKefar Saba, Israel Sheba Medical CenterRamat Gan, Israel|Fukuoka, Japan Kanazawa University HospitalKanazawa, Japan Gunma University HospitalMaebashi, Japan Hokkaido University HospitalSapporo, Japan National University Corporation Tohoku University Tohoku University HospitalSendai, Japan Osaka University HospitalSuita, Japan Nippon Medical School HospitalTokyo, Japan Yokohama City University HospitalYokohama, Japan Korea, Republic Of Seoul National University HospitalSeoul, Korea, Republic Of, 03080 Asan Medical CenterSeoul, Korea, Republic Of, 05505 Hanyang University Medical CenterSeoul, Korea, Republic Of The Catholic University Of Korea, Seoul St. Mary'S HospitalSeoul, Korea, Republic Of|Rotterdam, Netherlands Haga HospitalThe Hague, Netherlands|Leiden, South Holland, Netherlands|Lublin, Poland Medyczne Centrum HetmanskaPoznaÅ„, Poland Reum-Medica S.CWrocÅ‚aw, Poland|Barcelona, Spain Hospital Universitario Doctor PesetValencia, Spain|Saint Gallen, Switzerland University Hospital ZurichZÃ¼rich, Switzerland|Dundee, Scotland, United Kingdom, Dd1 9Sy|Newcastle, Tyne And Wear, United Kingdom, Ne7 7Dn|Dudley, West Midlands, United Kingdom, Dy1 2Hq|Leeds, United Kingdom Royal Free Hospital London Nhs Foundation TrustLondon, United Kingdom, Nw3 2Qg Guy'S And St.Thomas' Nhs Foundation TrustLondon, United Kingdom Salford Royal Nhs Foundation TrustSalford, United Kingdom, M6 8Hd|La Jolla, California, United States, 92037 Pacific Arthritis Care CenterLos Angeles, California, United States, 90045 UclaLos Angeles, California, United States, 90095 Stanford UniversityPalo Alto, California, United States, 94304|Aurora, Colorado, United States, 80045 United States, District Of Columbia Georgetown University Medical CenterWashington, District Of Columbia, United States, 20007|Chicago, Illinois, United States, 60611|New Orleans, Louisiana, United States, 70112|Baltimore, Maryland, United States, 21224|Boston, Massachusetts, United States, 02114 Boston University Medical Center (Bumc) - General Clinical Research Unit (Gcru)Boston, Massachusetts, United States, 02118|Ann Arbor, Michigan, United States, 48109|Minneapolis, Minnesota, United States, 55455|New Brunswick, New Jersey, United States, 08901|Albany, New York, United States, 12203 Columbia University Medical CenterNew York, New York, United States, 10032 Hospital For Special SurgeryNew York, New York, United States, 10065|Cleveland, Ohio, United States, 44195 University Of ToledoToledo, Ohio, United States, 43614|Philadelphia, Pennsylvania, United States, 19104 Upmc Arthritis And Autoimmunity Center, Falk ClinicPittsburgh, Pennsylvania, United States, 15261|Charleston, South Carolina, United States, 29425|Dallas, Texas, United States, 75231 Utp Rheumatology ClinicHouston, Texas, United States, 77030|Salt Lake City, Utah, United States, 84132|Milwaukee, Wisconsin, United States, 53226","California|Colorado|Illinois|Louisiana|Maryland|Massachusetts|Michigan|Minnesota|New Jersey|New York|Ohio|Pennsylvania|South Carolina|Texas|Utah|Wisconsin","Australia|Canada|Germany|Israel|Japan|Netherlands|Poland|Spain|Switzerland|United Kingdom|United States","Royal Adelaide Hospital|Sir Mortimer B. Davis Jewish General Hospital|Baden-WÃ¼rttemberg UniversitÃ¤tsklinikum Heidelberg|CharitÃ©- UniversitÃ¤tsmedizin Berlin, Klinik FÃ¼r Rheumatologie Und Klinische Immunologie, Abteilung -Neue Therapien & Studien-|Rambam Health Corporation|Kyushu University Hospital|Erasmus Medical Center|South Holland Leiden University Medical Center|Samodzielny Publiczny Szpital Kliniczny Nr 1; Katedra I Klinika Dermatologii, Wenerologii I Dermatologii DzieciÄ™cej Uniwersytetu Medycznego W Lublinie|Hospital Universitari De La Santa Creu I Sant Pau|Cantonal Hospital St. Gallen|, Scotland Ninewells Hospital|, Tyne And Wear Freeman Hospital|, West Midlands Russell's Hall Hospital|Leeds Institute Of Rheumatic And Musculoskeletal Medicine (Lirmm)|University Of California San Diego|University Of Colorado Anschutz Medical Campus|Northwestern University|Tulane University Medical Center|John Hopkins University, Scleroderma Center|Massachusetts General Hospital, Division Of Rheumatology|Michigan Medicine|University Of Minnesota Health Clinical Research Unit|Rutgers Clinical Research Center, Robert Wood Johnson Medical School|The Steffens Scleroderma At The Center For Rheumatology|Cleveland Clinic|University Of Pennsylvania Health System - Pcam, Dept. Of Rheumatology|Medical University Of South Carolina|Metroplex Clinical Research Center|University Of Utah Hospitals And Clinics|Medical College Of Wisconsin/Froedtert Hospital",{"$nulls":4},"2020-01-08","2020-05-25T16:36:45.974","2020-05-26T17:10:42.972","NCT03398837"]
["5ecbf41ce2561b1b11905d49","NCT03398876","2018-05-07","Johnson & Johnson","JNJ","Completed","A Study to Assess the Nicotine Pharmacokinetics, Tolerability and Safety With a New Oral Nicotine Replacement Product in Healthy Japanese Smokers","Nicotine","nAChR Agonist","No",null,"No",null,"Phase 1",6,24,"Actual","2017-12-22","2018-04-16","AUC|Clast","Area Under The Curve|Last Quantifiable Plasma Concentration",{"$nulls":3},"In Part 1, the purpose of this study is to elucidate the single-dose pharmacokinetic profiles of 1 spray and 2 consecutive sprays of oromucosal nicotine spray (ONS) in comparison with those of nicotine gum and cigarette smoking in healthy Japanese smokers. In Part 2, the purpose is to evaluate the multiple-dose nicotine pharmacokinetics of ONS administered repeated-dose administration in healthy Japanese smokers.",null,"A Single-dose and Repeated-dose, Open-label, Randomized, Cross-over Study to Assess the Nicotine Pharmacokinetics, Tolerability and Safety With A New Oral Nicotine Replacement Product in Healthy Japanese Smokers.","CR108422","Healthy","Healthy Volunteers","Healthy","Healthy","Experimental","Part 1; Treatment Sequence ABDC|Part 1; Treatment Sequence BCAD|Part 1; Treatment Sequence CDBA|Part 1; Treatment Sequence DACB|Part 2; Treatment Sequence EF|Part 2; Treatment Sequence FE","Participants will receive Treatment A (one spray of oromucosal nicotine spray [ONS]) at Visit 1, then Treatment B (2 consecutive sprays of ONS at Visit 2, then Treatment D (1 cigarette [10 puffs]) at Visit 3, followed by Treatment C (nicotine gum) at Visit 4. The visits will be separated by a period of at least 7 calendar days.|Participants will receive Treatment B at Visit 1, then Treatment C at Visit 2, then Treatment A at Visit 3 followed by Treatment D at Visit 4. The visits will be separated by a period of at least 7 calendar days.|Participants will receive Treatment C at Visit 1, then Treatment D at Visit 2, then Treatment B at Visit 3 followed by Treatment A at Visit 4. The visits will be separated by a period of at least 7 calendar days. The visits will be separated by a period of at least 7 calendar days.|Participants will receive Treatment D at Visit 1, then Treatment A at Visit 2, then Treatment C at Visit 3 followed by Treatment B at Visit 4. The visits will be separated by a period of at least 7 calendar days.|Participants who complete Part 1 will be selected for Part 2 based on the results of genetic polymorphism test and other examinations. Selected participants will receive Treatment E (two consecutive sprays of ONS once every 30 minutes until 11.5 hours) at Visit 5, followed by Treatment F (two consecutive sprays of ONS once every 1 hour until 11 hours) at Visit 6. The visits will be separated by a period of at least 7 calendar days.|Participants who complete Part 1 will be selected for Part 2 based on the results of genetic polymorphism test and other examinations. Selected participants will receive Treatment F at Visit 5 followed by Treatment E at Visit 6. The visits will be separated by a period of at least 7 calendar days.","Drug","Oromucosal Nicotine Spray (ONS)|Nicotine Gum","Participants will receive oral dose of oromucosal nicotine spray (ONS).|Participants will chew nicotine gum for 30 minutes.",null,"Part 1; Treatment Sequence ABDC|Part 1; Treatment Sequence BCAD|Part 1; Treatment Sequence CDBA|Part 1; Treatment Sequence DACB|Part 2; Treatment Sequence EF|Part 2; Treatment Sequence FE","\n\n * Healthy male or female Japanese participants between the ages of 20 and 50 years, inclusive. Health is defined as the absence of clinically relevant abnormalities identified by a detailed medical history, blood pressure, pulse rate measurements, 12-lead electrocardiogram (ECG) as well as clinical laboratory tests, as judged by the principal investigator or sub investigator.\n * Smoking of at least 15 cigarettes daily during at least one year preceding inclusion\n * Body Mass Index between 17.5 and 30.0 kilogram per square meter (kg/m^2) and a total body weight greater than or equal to (>=) 50.0 kg\n * Evidence of a personally signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study\n * All women of childbearing potential, except for postmenopausal females, must have a negative urine beta-human chorionic gonadotropin (beta-hCG) at screening of Part 1 and all planned visits of Part 1 and Part 2\n\n","\n\n * Evidence or history of an acute or chronic medical or psychiatric condition or allergy or laboratory abnormality, or of use of drugs that, in the judgment of the principal investigator or sub investigator, increase the risk associated with study participation or interfere with the interpretability of study results\n * Females: Pregnancy, breast-feeding, premenopausal, or perimenopausal state with insufficient contraception\n * Treatment with an investigational drug within 3 months preceding the first dose of study product\n * Participant has donated blood or blood product or had substantial loss of blood more than 200 milliliter (mL) within 1 month before study products administration, or greater than or equal to (>=) 400 mL within 3 months for males and 4 months for females before study products administration, or participant has donated a total volume of blood in the past one year exceeding 1,200 mL for males and 800 mL for females, or participant has an intention to donate blood or blood products during the study and for at least 3 months for males and 4 months for females for blood, or at least 2 months for both genders for blood products after completion of the study\n * Exclusion Criterion for Only Part 2: participants who is analyzed as cytochrome (CYP)2A6 *4/*4 by CYP2A6 genetic polymorphism test at Visit 1 of Part 1",{"$nulls":4},"Actual","2018-01-16","Actual","Actual","2018-04-16","Actual","2018-05-01","2017-12-22","2018-01-11","2018-05-04",null,null,"Interventional","Other","Crossover Assignment","None (Open Label)","Randomized","20 Years","50 Years","All",null,"Yes",{"$nulls":4},"No","No",{"$nulls":17},"10258820TDP1001","Janssen Pharmaceutical K.K., Japan","Part 1: Maximum Baseline Corrected Plasma Nicotine Concentration (cCmax)|Part 1: Baseline Corrected Area Under the Plasma Nicotine Concentration versus (vs) Time Curve Until the Last Measurable Time Point (cAUCt)|Part 1: Baseline Corrected Area Under the Plasma Nicotine Concentration-vs Time Curve Extrapolated to Infinite (cAUC[infinity])|Part 1: Baseline Corrected Area Under the Plasma Nicotine Concentration-vs Time Curve until the Last Measurable Time Point (cAUCt)|Part 2: Average Plasma Nicotine Concentration During the Last Dosing Interval/Intervals (Cav)|Part 2: Area Under the Plasma Nicotine Concentration-vs Time Curve During the Last Dosing Interval/Intervals (AUCtau)|Part 2: Maximum Plasma Nicotine Concentration During the Last Dosing Interval/Intervals (Cmax)","cCmax is defined as the maximum baseline corrected plasma nicotine concentration (cCmax).|cAUCt is defined as the baseline corrected area under the plasma nicotine concentration-vs time curve until the last measurable time point.|cAUC(infinity) is defined as the baseline corrected area under the plasma nicotine concentration-vs time curve extrapolated to infinite.|cAUCt is defined as baseline corrected area under the plasma nicotine concentration-vs time curve until the last measurable time point.|Cav is defined as the average plasma nicotine concentration during the last dosing interval/intervals.|AUCtau is defined as the area under the plasma nicotine concentration-vs time curve during the last dosing interval/intervals.|Cmax is defined as maximum observed plasma nicotine concentration.","Predose; 2, 4, 6, 8, 10, 15, 20, 30, 45 and 60 minute (min) and 1.5, 2, 3, 4, 6, 8, 10, 12 hours postdose|Predose; 2, 4, 6, 8, 10, 15, 20, 30, 45 and 60 min and 1.5, 2, 3, 4, 6, 8, 10, 12 hours postdose|Predose, 2, 4, 6, 8, 10, 15, 20, 30 post last dose (last dose: Hour 11.5 for Treatment E and Hour 11 for Treatment F); 45 and 60 min post last dose for Treatment F","Part 1: Area Under the Plasma Nicotine Concentration-vs Time Curve until 10 Minutes after Start of Administration [AUC10min],|Part 1: Time to Reach Maximum Observed Plasma Concentration (Tmax)|Part 1: Terminal Half-Life [t1/2]|Part 1: Terminal Elimination Rate Constant (Lambda[z])|Part 2: Minimum Plasma Nicotine Concentration During the Last Dosing Interval/Intervals (Cmin)|Part 2: Peak-Trough Fluctuation [PTF]|Part 2: Swing|Part 2: Time to Reach Maximum Observed Plasma Concentration (Tmax)|Part 1 and Part 2: Number of Participants with Adverse Events (AEs)","AUC10min is defined as the area under the plasma nicotine concentration-vs time curve until 10 minutes after start of administration.|Tmax is defined as actual sampling time to reach maximum observed analyte concentration.|Terminal half-life (t1/2) is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z).|Lambda (z) is apparent terminal elimination rate constant, determined by linear regression using the terminal log-linear phase of the log transformed concentration-time curve.|Cmin is defined as the minimum plasma nicotine concentration during the last dosing interval/intervals.|PTF calculated by 100*(Cmax - Cmin)/Cav will be assessed.|Swing will be calculated as (Cmax âˆ’ Cmin)/Cmin.|An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.","Predose; 2, 4, 6, 8, 10 min postdose|Predose; 2, 4, 6, 8, 10, 15, 20, 30, 45 and 60 min and 1.5, 2, 3, 4, 6, 8, 10, 12 hours postdose|Predose, 2, 4, 6, 8, 10, 15, 20, 30 post last dose (last dose: Hour 11.5 for Treatment E and Hour 11 for Treatment F); 45 and 60 min post last dose for Treatment F|Up to 4 months",{"$nulls":3},"Fukuoka, Japan, 8120025",null,"Japan","Souseikai Hakata Clinic",{"$nulls":3},"Janssen Pharmaceutical K.K., Japan Clinical Trial","2018-05-04","2020-05-25T16:36:44.197","2020-05-26T17:10:42.972","NCT03398876"]
["5ecbf41e11702c1b1b916a63","NCT03399084","2019-05-30","Sandoz","SDOZY","Completed","A Study Comparing Two Ferric Carboxymaltose Formulations in Patients With Iron Deficiency Anemia","Ferric carboxymaltose","Ferritin Agonist|Hemoglobin Agonist|Transferrin Agonist","No",null,"No",null,"Phase 1",2,71,"Actual","2017-11-29","2019-01-15","AUC","Area Under The Curve",{"$nulls":3},"This study will evaluate bioequivalence of two formulations of Ferric Carboxymaltose as measured by serum total iron, in adult patients with iron deficiency anemia.",null,"An Open-label, Randomized, Parallel, Bioequivalence Study of 750 mg Intravenous Single Dose Ferric Carboxymaltose Versus InjectaferÂ® (750 mg Iron/15 mL Colloidal Solution) in Adult Patients With Iron Deficiency Anemia","1637 FCM_1","Iron Deficiency Anemia","Anemia","Hematologic Diseases","Heme & Lymph Diseases","Experimental|Active Comparator","Ferric carboxymaltose (test)|Ferric carboxymaltose (reference)","Patients will receive a single dose of Ferric carboxymaltose","Drug","Ferric carboxymaltose","750 mg/15 mL",null,"Ferric carboxymaltose (test)|Ferric carboxymaltose (reference)","\n\n * Male and female patients at least 18 - 65 years of age;\n * Patients with a body mass index (BMI) between 18.5 - 35 and with a body weight of â‰¥50 kg - â‰¤130 kg;\n\n","\n\n * Patients with known hypersensitivity to ferric carboxymaltose, excipients, or similar product\n * Patients with chronic kidney disease who are on dialysis of any kind.\n * If female, is pregnant or nursing.\n * Patients with blood loss leading to hemodynamic instability\n * Patients with recent parenteral iron within 3 months prior to screening.\n\nOther inclusion/exclusion criteria may apply.",{"$nulls":4},"Actual","2018-01-16","Actual","Actual","2019-01-15","Actual","2019-05-01","2017-12-05","2018-01-11","2019-05-28","No","Ferric carboxymaltose\nAnemia","Interventional","Other","Parallel Assignment","None (Open Label)","Randomized","18 Years","65 Years","All",null,"No","No\nNovartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.\n\nThis trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":14},"Bioequivalence assessed by maximum serum concentration (Cmax)of serum total iron.|Bioequivalence assessed by area under the serum concentration-time curve (AUC) of serum total iron.","Measured by Cmax - The maximum plasma concentration of iron|Plasma Pharmacokinetics (PK) of study medication: Area Under the Plasma Concentration-time Curve (AUC)","Up to 7 days|Up to 7 Days","Maximum serum concentration (Cmax) of serum transferrin-bound iron.|Time of Cmax (Tmax) of serum total iron and transferrin-bound iron|Area under the serum concentration-time curve (AUC) of serum transferrin-bound iron|Apparent terminal rate constant of serum total iron and transferrin-bound iron|Apparent terminal half-life of serum total iron and transferrin-bound iron|Systemic clearance (CL) of serum total iron and transferrin-bound iron after intravenous dosing|Volume of distribution at steady state of serum total iron and transferrin-bound iron following intravenous dosing|Number of patients with adverse events as a measure of safety and tolerability","Plasma Pharmacokinetics (PK): The maximum plasma concentration|Plasma Pharmacokinetics (PK): Time of Cmax (Tmax)|Plasma Pharmacokinetics (PK): area under the serum concentration-time curve (AUC)|Plasma Pharmacokinetics (PK): Apparent terminal rate constant|Plasma Pharmacokinetics (PK): Apparent terminal half-life|Plasma Pharmacokinetics (PK): Systemic clearance (CL)|Plasma Pharmacokinetics (PK): Volume of distribution at steady state Plasma Pharmacokinetics (PK): Volume of distribution at steady state (Vss)|Up to 7 days","Up to 7 days|Up to 7 Days",{"$nulls":3},"Miami, Florida, United States, 33143","Florida","United States","Sandoz Investigative Site",{"$nulls":3},"Sandoz Sandoz","2019-05-28","2020-05-25T16:36:46.322","2020-05-26T17:10:42.972","NCT03399084"]
["5ecbf41ffe30261b1a048254","NCT03399370","2018-04-23","The Medicines Company","MDCO","Active, not recruiting","Inclisiran for Participants With Atherosclerotic Cardiovascular Disease and Elevated Low-density Lipoprotein Cholesterol (ORION-10)","Inclisiran",null,"Yes","['Inclisiran']","Unknown",null,"Phase 3",2,1561,"Actual","2017-12-21","2019-10-01",{"$nulls":5},"This is a Phase III, placebo-controlled, double-blind, randomized study in participants with ASCVD and elevated LDL-C despite maximum tolerated dose of LDL-C lowering therapies to evaluate the efficacy, safety, and tolerability of subcutaneous (SC) inclisiran injection(s). The study will be a multicenter study in the United States.",null,"A Placebo-Controlled, Double-Blind, Randomized Trial to Evaluate the Effect of 300 mg of Inclisiran Sodium Given as Subcutaneous Injections in Subjects With Atherosclerotic Cardiovascular Disease (ASCVD) and Elevated Low-Density Lipoprotein Cholesterol (LDL-C)","MDCO-PCS-17-04","ASCVD\nElevated Cholesterol",{"$nulls":3},"Experimental|Placebo Comparator","Inclisiran|Saline Solution","Inclisiran sodium 300 milligrams (mg) will be administered as a SC injection on Day 1, Day 90, then every 6 months.|Placebo will be administered as a SC injection of saline solution on Day 1, Day 90, then every 6 months.","Drug","Inclisiran Sodium|Placebo","Inclisiran is a small interfering ribonucleic acid (RNA) that inhibits PCSK9 synthesis.|Placebo will be supplied as sterile normal saline (0.9% sodium chloride in water for injection).","Saline Solution","Inclisiran|Saline Solution","\n\n 1. Male or female participants â‰¥18 years of age.\n 2. History of ASCVD (coronary heart disease [CHD], cardiovascular disease [CVD], or peripheral arterial disease [PAD]).\n 3. Serum LDL-C â‰¥1.8 millimole (mmol)/liter (L) (â‰¥70 mg/dL).\n 4. Fasting triglyceride <4.52 mmol/L (<400 mg/dL) at screening.\n 5. Participants on statins should be receiving a maximally tolerated dose.\n 6. Participants not receiving statins must have documented evidence of intolerance to all doses of at least 2 different statins.\n 7. Subjects on lipid-lower therapies (such as a statin and/or ezetimibe) should be on a stable dose for â‰¥30 days before screening with no planned medication or dose change during study participation.\n\n","\n\n 1. New York Heart Association (NYHA) class IV heart failure.\n 2. Uncontrolled cardiac arrhythmia\n 3. Uncontrolled severe hypertension\n 4. Active liver disease\n 5. Females who are pregnant or nursing, or who are of childbearing potential and unwilling to use at least 2 methods of highly effective contraception (failure rate less than 1% per year) (for example, combined oral contraceptives, barrier methods, approved contraceptive implant, long-term injectable contraception, or intrauterine device) for the entire duration of the study. Exemptions from this criterion: 1. Women >2 years postmenopausal (defined as 1 year or longer since last menstrual period) and more than 55 years of age.\n     2. Postmenopausal women (as defined above) and less than 55 years of age with a negative pregnancy test within 24 hours of randomization.\n     3. Women who are surgically sterilized at least 3 months prior to enrollment.\n    \n    \n 6. Males who are unwilling to use an acceptable method of birth control during the entire study period (such as condom with spermicide).\n 7. Treatment with other investigational products or devices within 30 days or 5 half-lives of the screening visit, whichever is longer.\n 8. Treatment (within 90 days of screening) with monoclonal antibodies directed towards PCSK9\n\nThe above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.",{"$nulls":4},"Actual","2018-01-16","Actual","Anticipated","2019-12-01","Anticipated","2018-04-01","2018-01-03","2018-01-08","2018-04-20","Yes","Inclisiran sodium\nASCVD\nLDL-C","Interventional","Treatment","Parallel Assignment","Double (Participant, Care Provider)","Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":19},"Percentage Change in LDL-C from Baseline to Day 510|Time-adjusted Percentage Change in LDL-C Levels from Baseline between Day 90 and Day 540","Baseline, Day 510|Baseline, Day 90, Day 540",null,"Absolute Change in LDL-C from Baseline to Day 510|Time-adjusted Absolute Change in LDL-C from Baseline between Day 90 and Day 540|Percentage Change in Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) from Baseline to Day 510|Percentage Change in Total Cholesterol from Baseline to Day 510|Percentage Change in Apolipoprotein B (ApoB) from Baseline to Day 510|Percentage Change in Non-HDL-C from Baseline to Day 510","Baseline, Day 510|Baseline, Day 90, Day 540",{"$nulls":4},"Birmingham, Alabama, United States, 35211 Research Site 10001-138Foley, Alabama, United States, 36535 Research Site 10001-113Huntsville, Alabama, United States, 35801 Research Site 10001-058Mobile, Alabama, United States, 36608 Research Site 10001-037Montgomery, Alabama, United States, 36117 Research Site 10001-076Saraland, Alabama, United States, 36571|Chandler, Arizona, United States, 85224 Research Site 10001-077Mesa, Arizona, United States, 85213 Research Site 10001-136Phoenix, Arizona, United States, 85014 Research Site 10001-051Surprise, Arizona, United States, 85374 Research Site 10001-019Tucson, Arizona, United States, 85712 Research Site 10001-004Tucson, Arizona, United States, 85741 Research Site 10001-132Tucson, Arizona, United States, 85745|Beverly Hills, California, United States, 90211 Research Site 10001-050Canoga Park, California, United States, 91303 Research Site 10001-011Carlsbad, California, United States, 92008 Research Site 10001-065El Cajon, California, United States, 92020 Research Site 10001-150Los Angeles, California, United States, 90022 Research Site 10001-043Northridge, California, United States, 91324 Research Site 10001-022Northridge, California, United States, 91325 Research Site 10001-033Sacramento, California, United States, 95821-2134 Research Site 10001-105San Ramon, California, United States, 94582 Research Site 10001-008Santa Rosa, California, United States, 95405 Research Site 10001-153Spring Valley, California, United States, 91978 Research Site 10001-044Torrance, California, United States, 90502|Boca Raton, Florida, United States, 33434 Research Site 10001-084Clearwater, Florida, United States, 33756 Research Site 10001-155Clearwater, Florida, United States, 33756 Research Site 10001-099Clearwater, Florida, United States, 33761 Research Site 10001-127Daytona Beach, Florida, United States, 32117 Research Site 10001-119Fleming Island, Florida, United States, 32003 Research Site 10001-070Fort Lauderdale, Florida, United States, 33308 Research Site 10001-067Hialeah, Florida, United States, 33012 Research Site 10001-139Jacksonville, Florida, United States, 32204 Research Site 10001-039Jacksonville, Florida, United States, 32216 Research Site 10001-098Jacksonville, Florida, United States, 32216 Research Site 10001-080Miami Springs, Florida, United States, 33166 Research Site 10001-081Miami, Florida, United States, 33126 Research Site 10001-140Miami, Florida, United States, 33126 Research Site 10001-142Miami, Florida, United States, 33126 Research Site 10001-030Miami, Florida, United States, 33165 Research Site 10001-089Miami, Florida, United States, 33173 Research Site 10001-116Miami, Florida, United States, 33183 Research Site 10001-027Pembroke Pines, Florida, United States, 33024 Research Site 10001-115Pembroke Pines, Florida, United States, 33027 Research Site 10001-048Pembroke Pines, Florida, United States, 33029 Research Site 10001-147Pembroke Pines, Florida, United States, 33029 Research Site 10001-003Pinellas Park, Florida, United States, 33781 Research Site 10001-104Ponte Vedra, Florida, United States, 32081 Research Site 10001-090Saint Augustine, Florida, United States, 32086 Research Site 10001-102Saint Petersburg, Florida, United States, 33713 Research Site 10001-123Sarasota, Florida, United States, 34239-3513 Research Site 10001-038Tampa, Florida, United States, 33607 Research Site 10001-143Tampa, Florida, United States, 33614|Atlanta, Georgia, United States, 30342 Research Site 10001-086Calhoun, Georgia, United States, 30701 Research Site 10001-131Decatur, Georgia, United States, 30030 Research Site 10001-137Dunwoody, Georgia, United States, 30338 Research Site 10001-092Macon, Georgia, United States, 31210|Arlington Heights, Illinois, United States, 60005 Research Site 10001-035Chicago, Illinois, United States, 60616 Research Site 10001-036Evanston, Illinois, United States, 60201|Indianapolis, Indiana, United States, 46260 Research Site 1001-020Sellersburg, Indiana, United States, 47172 Research Site 10001-040Valparaiso, Indiana, United States, 46383|West Des Moines, Iowa, United States, 50266|Hutchinson, Kansas, United States, 67502|Lexington, Kentucky, United States, 40503 Research Site 10001-108Lexington, Kentucky, United States, 40504 Research Site 10001-107Owensboro, Kentucky, United States, 42303|Crowley, Louisiana, United States, 70526 Research Site 10001-041Lake Charles, Louisiana, United States, 70601 Research Site 10001-101Monroe, Louisiana, United States, 71201|Flint, Michigan, United States, 48504 Research Site 10001-095Grandville, Michigan, United States, 49418 Research Site 10001-078Sterling Heights, Michigan, United States, 48310 Research Site 10001-034Troy, Michigan, United States, 48098|Edina, Minnesota, United States, 55435 Research Site 10001-096Minneapolis, Minnesota, United States, 55407 Research Site 10001-056Saint Paul, Minnesota, United States, 55102|Saint Louis, Missouri, United States, 63136 Research Site 10001-007Saint Louis, Missouri, United States, 63141|Omaha, Nebraska, United States, 68134 Research Site 10001-021Omaha, Nebraska, United States, 68144|Las Vegas, Nevada, United States, 89119 Research Site 10001-124Las Vegas, Nevada, United States, 89121|Bridgewater, New Jersey, United States, 08807 Research Site 10001-055Warren, New Jersey, United States, 07059|Albany, New York, United States, 12206 Research Site 10001-122Binghamton, New York, United States, 13901 Research Site 10001-128Endwell, New York, United States, 13760 Research Site 10001-042New Windsor, New York, United States, 12553 Research Site 10001-129Poughkeepsie, New York, United States, 12601 Research Site 10001-110Williamsville, New York, United States, 14221|Cary, North Carolina, United States, 27518 Research Site 10001-064Greensboro, North Carolina, United States, 27401 Research Site 10001-145Mooresville, North Carolina, United States, 28117 Research Site 10001-046Shelby, North Carolina, United States, 28150|Akron, Ohio, United States, 443311 Research Site 10001-120Cincinnati, Ohio, United States, 45219 Research Site 10001-154Cincinnati, Ohio, United States, 45227 Research Site 10001-010Cincinnati, Ohio, United States, 45236 Research Site 10001-134Cincinnati, Ohio, United States, 45246 Research Site 10001-014Columbus, Ohio, United States, 43212 Research Site 10001-012Columbus, Ohio, United States, 43213 Research Site 10001-141Dayton, Ohio, United States, 45419 Research Site 10001-148Marion, Ohio, United States, 43302|Edmond, Oklahoma, United States, 73003|Pittsburgh, Pennsylvania, United States, 15213 Research Site 10001-109Wyomissing, Pennsylvania, United States, 19610|Anderson, South Carolina, United States, 29621 Research Site 10001-062Greenville, South Carolina, United States, 29615 Research Site 10001-006Greer, South Carolina, United States, 29651 Research Site 10001-075.Greer, South Carolina, United States, 29651 Research Site 10001-111Myrtle Beach, South Carolina, United States, 29588 Research Site 10001-133Pelzer, South Carolina, United States, 29669 Research Site 10001-026Spartanburg, South Carolina, United States, 29303|Rapid City, South Dakota, United States, 57701|Athens, Tennessee, United States, 37303 Research Site 10001-152Greeneville, Tennessee, United States, 37745 Research Site 10001-130Kingsport, Tennessee, United States, 37660 Research Site 10001-118Knoxville, Tennessee, United States, 37909 Research Site 10001-106Knoxville, Tennessee, United States, 37917|Amarillo, Texas, United States, 79106 Research Site 10001-087Austin, Texas, United States, 78726 Research Site 10001-117Austin, Texas, United States, 78756 Research Site 10001-009Dallas, Texas, United States, 75234 Research Site 10001-068Edinburg, Texas, United States, 78503 Research Site 10001-126Fort Worth, Texas, United States, 76106 Research Site 10001-031Houston, Texas, United States, 77002 Research Site 10001-088Houston, Texas, United States, 77024 Research Site 10001-091Houston, Texas, United States, 77027 Research Site 10001-061Houston, Texas, United States, 77058 Research Site 10001-032Houston, Texas, United States, 77070 Research Site 10001-025Lubbock, Texas, United States, 79410 Research Site 10001-057New Braunfels, Texas, United States, 78130 Research Site 10001-079Round Rock, Texas, United States, 78681 Research Site 10001-071San Antonio, Texas, United States, 78229 Research Site 10001-083Schertz, Texas, United States, 78154 Research Site 10001-149Shavano Park, Texas, United States, 78231 Research Site 10001-045Tomball, Texas, United States, 77375|Layton, Utah, United States, 84041 Research Site 10001-002Salt Lake City, Utah, United States, 84123 Research Site 10001-052Salt Lake City, Utah, United States, 94107|Falls Church, Virginia, United States, 22042 Research Site 10001-085Manassas, Virginia, United States, 20110 Research Site 10001-094Midlothian, Virginia, United States, 23114 Research Site 10001-023Richmond, Virginia, United States, 23294 Research Site 10001-029Suffolk, Virginia, United States, 23435|Tacoma, Washington, United States, 98405","Alabama|Arizona|California|Florida|Georgia|Illinois|Indiana|Iowa|Kansas|Kentucky|Louisiana|Michigan|Minnesota|Missouri|Nebraska|Nevada|New Jersey|New York|North Carolina|Ohio|Oklahoma|Pennsylvania|South Carolina|South Dakota|Tennessee|Texas|Utah|Virginia|Washington","United States","Research Site 10001-015|Research Site 10001-013|Research Site 10001-073|Exresearch Site 10001-047|Research Site 10001-069|Research Site 10001-059|Research Site 10001-082|Research Site 10001-074|Research Site 10001-028|Research Site 10001-125|Research Site 10001-144|Research Site 10001-024|Research Site 10001-018|Research Site 10001-156|Research Site 10001-053|Research Site 10001-112|Research Site 10001-060|Research Site 10001-054|Research Site 10001-063|Research Site 10001-016|Research Site 10001-017|Research Site 10001-151|Research Site 10001-001|Research Site 10001-103|Research Site 10001-146|Research Site 10001-100|Research Site 10001-005|Research Site 10001-093|Research Site 10001-114",{"$nulls":4},"2018-04-20","2020-05-25T16:36:47.045","2020-05-26T17:10:42.972","NCT03399370"]
["5ecbf41e11702c1b1b916a64","NCT03399370","2019-02-06","The Medicines Company","MDCO","Active, not recruiting","Inclisiran for Participants With Atherosclerotic Cardiovascular Disease and Elevated Low-density Lipoprotein Cholesterol (ORION-10)","Inclisiran",null,"Yes","['Inclisiran']","Unknown",null,"Phase 3",2,1561,"Actual","2017-12-21","2019-10-01",{"$nulls":5},"This is a Phase III, placebo-controlled, double-blind, randomized study in participants with ASCVD and elevated LDL-C despite maximum tolerated dose of LDL-C lowering therapies to evaluate the efficacy, safety, and tolerability of subcutaneous (SC) inclisiran injection(s). The study will be a multicenter study in the United States.",null,"A Placebo-Controlled, Double-Blind, Randomized Trial to Evaluate the Effect of 300 mg of Inclisiran Sodium Given as Subcutaneous Injections in Subjects With Atherosclerotic Cardiovascular Disease (ASCVD) and Elevated Low-Density Lipoprotein Cholesterol (LDL-C)","MDCO-PCS-17-04","ASCVD\nElevated Cholesterol",{"$nulls":3},"Experimental|Placebo Comparator","Inclisiran|Saline Solution","Inclisiran sodium 300 milligrams (mg) will be administered as a SC injection on Day 1, Day 90, then every 6 months.|Placebo will be administered as a SC injection of saline solution on Day 1, Day 90, then every 6 months.","Drug","Inclisiran Sodium|Placebo","Inclisiran is a small interfering ribonucleic acid (RNA) that inhibits PCSK9 synthesis.|Placebo will be supplied as sterile normal saline (0.9% sodium chloride in water for injection).","Saline Solution","Inclisiran|Saline Solution","\n\n 1. Male or female participants â‰¥18 years of age.\n 2. History of ASCVD (coronary heart disease [CHD], cardiovascular disease [CVD], or peripheral arterial disease [PAD]).\n 3. Serum LDL-C â‰¥1.8 millimole (mmol)/liter (L) (â‰¥70 mg/dL).\n 4. Fasting triglyceride <4.52 mmol/L (<400 mg/dL) at screening.\n 5. Participants on statins should be receiving a maximally tolerated dose.\n 6. Participants not receiving statins must have documented evidence of intolerance to all doses of at least 2 different statins.\n 7. Subjects on lipid-lower therapies (such as a statin and/or ezetimibe) should be on a stable dose for â‰¥30 days before screening with no planned medication or dose change during study participation.\n\n","\n\n 1. New York Heart Association (NYHA) class IV heart failure.\n 2. Uncontrolled cardiac arrhythmia\n 3. Uncontrolled severe hypertension\n 4. Active liver disease\n 5. Females who are pregnant or nursing, or who are of childbearing potential and unwilling to use at least 2 methods of highly effective contraception (failure rate less than 1% per year) (for example, combined oral contraceptives, barrier methods, approved contraceptive implant, long-term injectable contraception, or intrauterine device) for the entire duration of the study. Exemptions from this criterion: 1. Women >2 years postmenopausal (defined as 1 year or longer since last menstrual period) and more than 55 years of age.\n     2. Postmenopausal women (as defined above) and less than 55 years of age with a negative pregnancy test within 24 hours of randomization.\n     3. Women who are surgically sterilized at least 3 months prior to enrollment.\n    \n    \n 6. Males who are unwilling to use an acceptable method of birth control during the entire study period (such as condom with spermicide).\n 7. Treatment with other investigational products or devices within 30 days or 5 half-lives of the screening visit, whichever is longer.\n 8. Treatment (within 90 days of screening) with monoclonal antibodies directed towards PCSK9\n\nThe above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.",{"$nulls":4},"Actual","2018-01-16","Actual","Anticipated","2019-12-01","Anticipated","2019-02-01","2018-01-03","2018-01-08","2019-02-05","Yes","Inclisiran sodium\nASCVD\nLDL-C","Interventional","Treatment","Parallel Assignment","Double (Participant, Care Provider)","Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":19},"Percentage Change in LDL-C from Baseline to Day 510|Time-adjusted Percentage Change in LDL-C Levels from Baseline between Day 90 and Day 540","Baseline, Day 510|Baseline, Day 90, Day 540",null,"Absolute Change in LDL-C from Baseline to Day 510|Time-adjusted Absolute Change in LDL-C from Baseline between Day 90 and Day 540|Percentage Change in Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) from Baseline to Day 510|Percentage Change in Total Cholesterol from Baseline to Day 510|Percentage Change in Apolipoprotein B (ApoB) from Baseline to Day 510|Percentage Change in Non-HDL-C from Baseline to Day 510","Baseline, Day 510|Baseline, Day 90, Day 540",{"$nulls":4},"Birmingham, Alabama, United States, 35211 Research Site 10001-138Foley, Alabama, United States, 36535 Research Site 10001-113Huntsville, Alabama, United States, 35801 Research Site 10001-058Mobile, Alabama, United States, 36608 Research Site 10001-037Montgomery, Alabama, United States, 36117 Research Site 10001-076Saraland, Alabama, United States, 36571|Chandler, Arizona, United States, 85224 Research Site 10001-077Mesa, Arizona, United States, 85213 Research Site 10001-136Phoenix, Arizona, United States, 85014 Research Site 10001-051Surprise, Arizona, United States, 85374 Research Site 10001-019Tucson, Arizona, United States, 85712 Research Site 10001-004Tucson, Arizona, United States, 85741 Research Site 10001-132Tucson, Arizona, United States, 85745|Beverly Hills, California, United States, 90211 Research Site 10001-050Canoga Park, California, United States, 91303 Research Site 10001-011Carlsbad, California, United States, 92008 Research Site 10001-065El Cajon, California, United States, 92020 Research Site 10001-150Los Angeles, California, United States, 90022 Research Site 10001-043Northridge, California, United States, 91324 Research Site 10001-022Northridge, California, United States, 91325 Research Site 10001-033Sacramento, California, United States, 95821-2134 Research Site 10001-105San Ramon, California, United States, 94582 Research Site 10001-008Santa Rosa, California, United States, 95405 Research Site 10001-153Spring Valley, California, United States, 91978 Research Site 10001-044Torrance, California, United States, 90502|Boca Raton, Florida, United States, 33434 Research Site 10001-084Clearwater, Florida, United States, 33756 Research Site 10001-155Clearwater, Florida, United States, 33756 Research Site 10001-099Clearwater, Florida, United States, 33761 Research Site 10001-127Daytona Beach, Florida, United States, 32117 Research Site 10001-119Fleming Island, Florida, United States, 32003 Research Site 10001-070Fort Lauderdale, Florida, United States, 33308 Research Site 10001-067Hialeah, Florida, United States, 33012 Research Site 10001-139Jacksonville, Florida, United States, 32204 Research Site 10001-039Jacksonville, Florida, United States, 32216 Research Site 10001-098Jacksonville, Florida, United States, 32216 Research Site 10001-080Miami Springs, Florida, United States, 33166 Research Site 10001-081Miami, Florida, United States, 33126 Research Site 10001-140Miami, Florida, United States, 33126 Research Site 10001-142Miami, Florida, United States, 33126 Research Site 10001-030Miami, Florida, United States, 33165 Research Site 10001-089Miami, Florida, United States, 33173 Research Site 10001-116Miami, Florida, United States, 33183 Research Site 10001-027Pembroke Pines, Florida, United States, 33024 Research Site 10001-115Pembroke Pines, Florida, United States, 33027 Research Site 10001-048Pembroke Pines, Florida, United States, 33029 Research Site 10001-147Pembroke Pines, Florida, United States, 33029 Research Site 10001-003Pinellas Park, Florida, United States, 33781 Research Site 10001-104Ponte Vedra, Florida, United States, 32081 Research Site 10001-090Saint Augustine, Florida, United States, 32086 Research Site 10001-102Saint Petersburg, Florida, United States, 33713 Research Site 10001-123Sarasota, Florida, United States, 34239-3513 Research Site 10001-038Tampa, Florida, United States, 33607 Research Site 10001-143Tampa, Florida, United States, 33614|Atlanta, Georgia, United States, 30342 Research Site 10001-131Decatur, Georgia, United States, 30030 Research Site 10001-137Dunwoody, Georgia, United States, 30338 Research Site 10001-092Macon, Georgia, United States, 31210|Arlington Heights, Illinois, United States, 60005 Research Site 10001-035Chicago, Illinois, United States, 60616 Research Site 10001-036Evanston, Illinois, United States, 60201|Indianapolis, Indiana, United States, 46260 Research Site 1001-020Sellersburg, Indiana, United States, 47172 Research Site 10001-040Valparaiso, Indiana, United States, 46383|West Des Moines, Iowa, United States, 50266|Hutchinson, Kansas, United States, 67502|Lexington, Kentucky, United States, 40503 Research Site 10001-108Lexington, Kentucky, United States, 40504 Research Site 10001-107Owensboro, Kentucky, United States, 42303|Crowley, Louisiana, United States, 70526 Research Site 10001-041Lake Charles, Louisiana, United States, 70601 Research Site 10001-101Monroe, Louisiana, United States, 71201|Flint, Michigan, United States, 48504 Research Site 10001-095Grandville, Michigan, United States, 49418 Research Site 10001-078Sterling Heights, Michigan, United States, 48310 Research Site 10001-034Troy, Michigan, United States, 48098|Edina, Minnesota, United States, 55435 Research Site 10001-096Minneapolis, Minnesota, United States, 55407 Research Site 10001-056Saint Paul, Minnesota, United States, 55102|Saint Louis, Missouri, United States, 63136 Research Site 10001-007Saint Louis, Missouri, United States, 63141|Omaha, Nebraska, United States, 68134 Research Site 10001-021Omaha, Nebraska, United States, 68144|Las Vegas, Nevada, United States, 89119 Research Site 10001-124Las Vegas, Nevada, United States, 89121|Bridgewater, New Jersey, United States, 08807 Research Site 10001-055Warren, New Jersey, United States, 07059|Albany, New York, United States, 12206 Research Site 10001-122Binghamton, New York, United States, 13901 Research Site 10001-128Endwell, New York, United States, 13760 Research Site 10001-042New Windsor, New York, United States, 12553 Research Site 10001-129Poughkeepsie, New York, United States, 12601 Research Site 10001-110Williamsville, New York, United States, 14221|Cary, North Carolina, United States, 27518 Research Site 10001-064Greensboro, North Carolina, United States, 27401 Research Site 10001-145Mooresville, North Carolina, United States, 28117 Research Site 10001-046Shelby, North Carolina, United States, 28150|Akron, Ohio, United States, 443311 Research Site 10001-120Cincinnati, Ohio, United States, 45219 Research Site 10001-154Cincinnati, Ohio, United States, 45227 Research Site 10001-010Cincinnati, Ohio, United States, 45236 Research Site 10001-134Cincinnati, Ohio, United States, 45246 Research Site 10001-014Columbus, Ohio, United States, 43212 Research Site 10001-012Columbus, Ohio, United States, 43213 Research Site 10001-141Dayton, Ohio, United States, 45419 Research Site 10001-148Marion, Ohio, United States, 43302|Edmond, Oklahoma, United States, 73003|Pittsburgh, Pennsylvania, United States, 15213 Research Site 10001-109Wyomissing, Pennsylvania, United States, 19610|Anderson, South Carolina, United States, 29621 Research Site 10001-062Greenville, South Carolina, United States, 29615 Research Site 10001-006Greer, South Carolina, United States, 29651 Research Site 10001-075.Greer, South Carolina, United States, 29651 Research Site 10001-111Myrtle Beach, South Carolina, United States, 29588 Research Site 10001-133Pelzer, South Carolina, United States, 29669 Research Site 10001-026Spartanburg, South Carolina, United States, 29303|Rapid City, South Dakota, United States, 57701|Athens, Tennessee, United States, 37303 Research Site 10001-152Greeneville, Tennessee, United States, 37745 Research Site 10001-130Kingsport, Tennessee, United States, 37660 Research Site 10001-118Knoxville, Tennessee, United States, 37909 Research Site 10001-106Knoxville, Tennessee, United States, 37917|Amarillo, Texas, United States, 79106 Research Site 10001-087Austin, Texas, United States, 78726 Research Site 10001-117Austin, Texas, United States, 78756 Research Site 10001-009Dallas, Texas, United States, 75234 Research Site 10001-068Edinburg, Texas, United States, 78503 Research Site 10001-126Fort Worth, Texas, United States, 76106 Research Site 10001-031Houston, Texas, United States, 77002 Research Site 10001-088Houston, Texas, United States, 77024 Research Site 10001-091Houston, Texas, United States, 77027 Research Site 10001-061Houston, Texas, United States, 77058 Research Site 10001-032Houston, Texas, United States, 77070 Research Site 10001-025Lubbock, Texas, United States, 79410 Research Site 10001-057New Braunfels, Texas, United States, 78130 Research Site 10001-079Round Rock, Texas, United States, 78681 Research Site 10001-071San Antonio, Texas, United States, 78229 Research Site 10001-083Schertz, Texas, United States, 78154 Research Site 10001-149Shavano Park, Texas, United States, 78231 Research Site 10001-045Tomball, Texas, United States, 77375|Layton, Utah, United States, 84041 Research Site 10001-002Salt Lake City, Utah, United States, 84123 Research Site 10001-052Salt Lake City, Utah, United States, 94107|Falls Church, Virginia, United States, 22042 Research Site 10001-085Manassas, Virginia, United States, 20110 Research Site 10001-094Midlothian, Virginia, United States, 23114 Research Site 10001-023Richmond, Virginia, United States, 23294 Research Site 10001-029Suffolk, Virginia, United States, 23435|Tacoma, Washington, United States, 98405","Alabama|Arizona|California|Florida|Georgia|Illinois|Indiana|Iowa|Kansas|Kentucky|Louisiana|Michigan|Minnesota|Missouri|Nebraska|Nevada|New Jersey|New York|North Carolina|Ohio|Oklahoma|Pennsylvania|South Carolina|South Dakota|Tennessee|Texas|Utah|Virginia|Washington","United States","Research Site 10001-015|Research Site 10001-013|Research Site 10001-073|Exresearch Site 10001-047|Research Site 10001-069|Research Site 10001-059|Research Site 10001-082|Research Site 10001-074|Research Site 10001-028|Research Site 10001-125|Research Site 10001-144|Research Site 10001-024|Research Site 10001-018|Research Site 10001-156|Research Site 10001-053|Research Site 10001-112|Research Site 10001-060|Research Site 10001-054|Research Site 10001-063|Research Site 10001-016|Research Site 10001-017|Research Site 10001-151|Research Site 10001-001|Research Site 10001-103|Research Site 10001-146|Research Site 10001-100|Research Site 10001-005|Research Site 10001-093|Research Site 10001-114",{"$nulls":4},"2019-02-05","2020-05-25T16:36:46.997","2020-05-26T17:10:42.972","NCT03399370"]
["5ecbf42011702c1b1b916a67","NCT03399604","2018-01-16","Liquidia Technologies","LQDA","Recruiting","Investigation of the Safety and Pharmacology of Dry Powder Inhalation of Treprostinil (INSPIRE)","Epoprostenol|Treprostinil","PGI2 Agonist|PA Inhibitor|PGI2 Agonist","No",null,"No",null,"Phase 3",1,100,"Anticipated","2018-01-02","2019-07-31",null,null,"Nuventra, Inc.",null,null,"The primary objective of this study is to evaluate the long-term safety and tolerability of LIQ861, a dry powder formulation of treprostinil, in patients with Pulmonary Arterial Hypertension (PAH). A secondary objective of this study is to evaluate the comparative bioavailability of treprostinil between two formulations of inhaled therapy.","One of the greatest impediments to patient treatment satisfaction with current inhaled treprostinil therapy is inconvenience. Currently, PAH patients using inhaled treprostinil may require more than 36 breaths per day using a nebulizer requiring daily set up and cleaning. The use of a discrete, hand-held dry powder inhaler to deliver treprostinil to the lungs could represent a major improvement in convenience and patient satisfaction, thereby improving the quality of life for PAH patients. Liquidia is pursuing approval of LIQ861, an inhalation dry powder formulation of treprostinil that is produced using Liquidia's PRINTÂ® Technology (Particle Replication in Nonwetting Templates), as an alternative to current inhaled treprostinil therapy for the treatment of patients with PAH (WHO Group 1).","A Phase 3 Open-label, Multicenter Study to Evaluate the Long-term Safety and Tolerability of Inhaled LIQ861(Treprostinil) in Pulmonary Arterial Hypertension (WHO Group 1) Patients","LTI-301","Primary Pulmonary Hypertension","Hypertension|Hypertension, Pulmonary","Vascular Diseases|Lung Diseases","Cardiovascular|Respiratory","Experimental","LIQ861 Inhaled Treprostinil",null,"Drug","LIQ861 Inhaled Treprostinil","LIQ861 bulk powder is generated from a treprostinil/excipient matrix from which particles of precise size and shape are created and filled into a hydroxypropyl methylcellulose (HPMC) capsule (size 3). LIQ861 capsules are provided in capsule strengths of 25 Î¼g, 50 Î¼g, 75 Î¼g and 100 Î¼g treprostinil.","inhaled treprostinil | inhaled prostacyclin","LIQ861 Inhaled Treprostinil","\n\n * signed informed consent by patient prior to study enrollment\n * 18 years of age or older\n * If female of childbearing potential, a negative pregnancy test at the Baseline Visit and agrees to practice adequate birth control throughout the duration of the study. If the patient is postmenopausal or has documented surgical sterilization, a pregnancy test and birth control is not necessary.\n * The patient has been diagnosed with PAH belonging to the following subgroups of the updated Nice Clinical Classification Group 1 (Simonneau, Gatzoulis et al. 2013), which include: 1. Idiopathic PAH (1.1), or\n    2. Heritable PAH (1.2), or\n    3. Drug and toxin induced PAH (1.3), or\n    4. PAH associated with connective tissue disease (1.4.1), HIV infection (1.4.2), or congenital heart disease (1.4.4) with simple systemic-to-pulmonary shunt at least 1 year after surgical repair\n   \n   \n * The patient has been diagnosed with PAH and is NYHA Functional Class II - IV at Screening. 1. has documented stable doses of approved inhaled therapy for at least 3 months prior to screening and is willing and able to transition from their prescribed dose of inhaled therapy to study drug, or\n    2. has documented stable doses of no more than two approved oral therapies for at least 3 months prior to screening and is willing and able to add LIQ861 to their treatment regimen.\n   \n   \n * The patient can complete a baseline six-minute walk distance (6MWD) â‰¥ 150 m.\n * The patient has had evidence of FEV1 â‰¥ 60% and FEV1/FVC ratio â‰¥ 60% during the 6-month period prior to enrollment.\n\n","\n\n * The patient's clinical condition is such that, in the opinion of the Investigator, they are not expected to remain clinically stable for the duration of the study.\n * Patients with PH in the Updated Nice Classification Groups 2-5, or PAH Group 1 subgroups not covered by the inclusion criteria (e.g., associated with portal hypertension [1.4.3] or with schistosomiasis [1.4.5]).\n * The patient is currently taking oral prostacyclin analogues or agonists, including treprostinil and selexipag.\n * The patient has had any PAH medication (except for anticoagulants) discontinued within 14 days of Baseline.\n * The patient has had a new type of chronic therapy (including but not limited to oxygen, a different class of vasodilator, diuretic, digoxin, and digitalis) for pulmonary hypertension added within 30 days of Baseline.\n * The patient has uncontrolled systemic hypertension as evidenced by persistent systolic blood pressure greater than 160 mmHg or diastolic blood pressure greater than 100 mmHg.\n * The patient has a history of hemodynamically significant left-sided heart disease including, but not limited to: aortic or mitral valve disease, pericardial constriction, restrictive or congestive cardiomyopathy, or coronary artery disease (CAD).\n * The patient has had an atrial septostomy.\n * The patient has any serious or life-threatening disease other than conditions associated with PAH (e.g. malignancy requiring aggressive chemotherapy, end stage renal disease, etc.).\n * The patient is taking any excluded medications listed in the Investigator's Brochure, namely inhibitors and inducers of CYP2C8\n * The patient has a hypersensitivity or allergy to any of the ingredients of LIQ861 or other clinically relevant allergies (clinical relevance per Investigator judgment).\n * The patient has had a pulmonary infarction (defined as infarction in more than one lung segment documented by V/Q scan or pulmonary angiography) within two weeks of Screening.\n * The patient has had a stroke or transient ischemic attack (TIA) within six months of Screening.\n * The patient has evidence of an active uncontrolled sepsis or systemic infection during Screening.\n * The patient is pregnant or lactating.\n * The patient has any musculoskeletal disease or any other disease that would limit ambulation.\n * The patient has participated in an investigational product or device study within the 30 days prior to Screening.\n * The patient has current evidence of drug abuse in the opinion of the Investigator.\n * The patient has severe hepatic impairment as evidenced by any history of ascites AND encephalopathy.\n * The patient has severe renal impairment (eGFR < 35).\n * The patient is taking inhaled treprostinil doses of greater than 90 Î¼g (more than 15 breaths).\n\nAdditional Exclusion Criteria for PK Sub-Study:\n\n * The patient meets any of Primary Exclusion Criteria #1 - 19.\n * The patient has moderate or severe renal impairment (eGFR < 60).\n * The patient is taking inhaled treprostinil doses of greater than 72 Î¼g (more than 12 breaths).",{"$nulls":4},"Actual","2018-01-16","Actual","Anticipated","2020-07-31","Anticipated","2018-01-01","2018-01-03","2018-01-12","2018-01-12","No","Pulmonary Arterial Hypertension\nIdiopathic Pulmonary Arterial Hypertension\nHeritable Pulmonary Arterial Hypertension\nDrug Induced Pulmonary Arterial Hypertension\nToxin Induced Pulmonary Arterial Hypertension\nConnective tissue disease","Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No","Undecided",{"$nulls":3},"Yes","No",{"$nulls":19},"Incidence of Treatment-Emergent Adverse Events and Serious Adverse Events","Treatment-Emergent Adverse Events and Serious Adverse Events will be grouped by MedDRA System Organ Class, dose level, time on drug, and relationship to dose titration","Baseline, Week 2, Month 1, Month 2 Visits, with bimonthly follow up for up to 30 months.",{"$nulls":3},"ClinicalTrials@Liquidia.com","Executive Director, Clinical Operations","(919) 328-4368","Louisville, Kentucky, United States, 40202","Kentucky","United States","Kentuckiana Pulmonary Research Center",{"$nulls":4},"2018-01-12","2020-05-25T16:36:48.771","2020-05-26T17:10:42.972","NCT03399604"]
["5ecbf421fe30261b1a048258","NCT03399604","2018-06-29","Liquidia Technologies","LQDA","Recruiting","Investigation of the Safety and Pharmacology of Dry Powder Inhalation of Treprostinil (INSPIRE)","Epoprostenol|Treprostinil","PGI2 Agonist|PA Inhibitor|PGI2 Agonist","No",null,"No",null,"Phase 3",1,100,"Anticipated","2018-01-02","2019-07-31",null,null,"Nuventra, Inc.",null,null,"The primary objective of this study is to evaluate the long-term safety and tolerability of LIQ861, a dry powder formulation of treprostinil, in patients with Pulmonary Arterial Hypertension (PAH). A secondary objective of this study is to evaluate the comparative bioavailability of treprostinil between two formulations of inhaled therapy.","One of the greatest impediments to patient treatment satisfaction with current inhaled treprostinil therapy is inconvenience. Currently, PAH patients using inhaled treprostinil may require more than 36 breaths per day using a nebulizer requiring daily set up and cleaning. The use of a discrete, hand-held dry powder inhaler to deliver treprostinil to the lungs could represent a major improvement in convenience and patient satisfaction, thereby improving the quality of life for PAH patients. Liquidia is pursuing approval of LIQ861, an inhalation dry powder formulation of treprostinil that is produced using Liquidia's PRINTÂ® Technology (Particle Replication in Nonwetting Templates), as an alternative to current inhaled treprostinil therapy for the treatment of patients with PAH (WHO Group 1).","A Phase 3 Open-label, Multicenter Study to Evaluate the Long-term Safety and Tolerability of Inhaled LIQ861(Treprostinil) in Pulmonary Arterial Hypertension (WHO Group 1) Patients","LTI-301","Primary Pulmonary Hypertension","Hypertension|Hypertension, Pulmonary","Vascular Diseases|Lung Diseases","Cardiovascular|Respiratory","Experimental","LIQ861 Inhaled Treprostinil",null,"Drug","LIQ861 Inhaled Treprostinil","LIQ861 bulk powder is generated from a treprostinil/excipient matrix from which particles of precise size and shape are created and filled into a hydroxypropyl methylcellulose (HPMC) capsule (size 3). LIQ861 capsules are provided in capsule strengths of 25 Î¼g, 50 Î¼g, 75 Î¼g and 100 Î¼g treprostinil.","inhaled treprostinil | inhaled prostacyclin","LIQ861 Inhaled Treprostinil","\n\n * signed informed consent by patient prior to study enrollment\n * 18 years of age or older\n * If female of childbearing potential, a negative pregnancy test at the Baseline Visit and agrees to practice adequate birth control throughout the duration of the study. If the patient is postmenopausal or has documented surgical sterilization, a pregnancy test and birth control is not necessary.\n * The patient has been diagnosed with PAH belonging to the following subgroups of the updated Nice Clinical Classification Group 1 (Simonneau, Gatzoulis et al. 2013), which include: 1. Idiopathic PAH (1.1), or\n    2. Heritable PAH (1.2), or\n    3. Drug and toxin induced PAH (1.3), or\n    4. PAH associated with connective tissue disease (1.4.1), HIV infection (1.4.2), or congenital heart disease (1.4.4) with simple systemic-to-pulmonary shunt at least 1 year after surgical repair\n   \n   \n * The patient has been diagnosed with PAH and is NYHA Functional Class II - IV at Screening. 1. has documented stable doses of approved inhaled therapy for at least 3 months prior to screening and is willing and able to transition from their prescribed dose of inhaled therapy to study drug, or\n    2. has documented stable doses of no more than two approved oral therapies for at least 3 months prior to screening and is willing and able to add LIQ861 to their treatment regimen.\n   \n   \n * The patient can complete a baseline six-minute walk distance (6MWD) â‰¥ 150 m.\n * The patient has had evidence of FEV1 â‰¥ 60% and FEV1/FVC ratio â‰¥ 60% during the 6-month period prior to enrollment.\n\n","\n\n * The patient's clinical condition is such that, in the opinion of the Investigator, they are not expected to remain clinically stable for the duration of the study.\n * Patients with PH in the Updated Nice Classification Groups 2-5, or PAH Group 1 subgroups not covered by the inclusion criteria (e.g., associated with portal hypertension [1.4.3] or with schistosomiasis [1.4.5]).\n * The patient is currently taking oral prostacyclin analogues or agonists, including treprostinil and selexipag.\n * The patient has had any PAH medication (except for anticoagulants) discontinued within 14 days of Baseline.\n * The patient has had a new type of chronic therapy (including but not limited to oxygen, a different class of vasodilator, diuretic, digoxin, and digitalis) for pulmonary hypertension added within 30 days of Baseline.\n * The patient has uncontrolled systemic hypertension as evidenced by persistent systolic blood pressure greater than 160 mmHg or diastolic blood pressure greater than 100 mmHg.\n * The patient has a history of hemodynamically significant left-sided heart disease including, but not limited to: aortic or mitral valve disease, pericardial constriction, restrictive or congestive cardiomyopathy, or coronary artery disease (CAD).\n * The patient has had an atrial septostomy.\n * The patient has any serious or life-threatening disease other than conditions associated with PAH (e.g. malignancy requiring aggressive chemotherapy, end stage renal disease, etc.).\n * The patient is taking any excluded medications listed in the Investigator's Brochure, namely inhibitors and inducers of CYP2C8\n * The patient has a hypersensitivity or allergy to any of the ingredients of LIQ861 or other clinically relevant allergies (clinical relevance per Investigator judgment).\n * The patient has had a pulmonary infarction (defined as infarction in more than one lung segment documented by V/Q scan or pulmonary angiography) within two weeks of Screening.\n * The patient has had a stroke or transient ischemic attack (TIA) within six months of Screening.\n * The patient has evidence of an active uncontrolled sepsis or systemic infection during Screening.\n * The patient is pregnant or lactating.\n * The patient has any musculoskeletal disease or any other disease that would limit ambulation.\n * The patient has participated in an investigational product or device study within the 30 days prior to Screening.\n * The patient has current evidence of drug abuse in the opinion of the Investigator.\n * The patient has severe hepatic impairment as evidenced by any history of ascites AND encephalopathy.\n * The patient has severe renal impairment (eGFR < 35).\n * The patient is taking inhaled treprostinil doses of greater than 90 Î¼g (more than 15 breaths).\n\nAdditional Exclusion Criteria for PK Sub-Study:\n\n * The patient meets any of Primary Exclusion Criteria #1 - 19.\n * The patient has moderate or severe renal impairment (eGFR < 60).\n * The patient is taking inhaled treprostinil doses of greater than 72 Î¼g (more than 12 breaths).",{"$nulls":4},"Actual","2018-01-16","Actual","Anticipated","2020-07-31","Anticipated","2018-06-01","2018-01-03","2018-01-12","2018-06-27","No","Pulmonary Arterial Hypertension\nIdiopathic Pulmonary Arterial Hypertension\nHeritable Pulmonary Arterial Hypertension\nDrug Induced Pulmonary Arterial Hypertension\nToxin Induced Pulmonary Arterial Hypertension\nConnective tissue disease","Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No","Undecided",{"$nulls":3},"Yes","No",{"$nulls":19},"Incidence of Treatment-Emergent Adverse Events and Serious Adverse Events","Treatment-Emergent Adverse Events and Serious Adverse Events will be grouped by MedDRA System Organ Class, dose level, time on drug, and relationship to dose titration","Baseline, Week 2, Month 1, Month 2 Visits, with bimonthly follow up for up to 30 months.",{"$nulls":3},"ClinicalTrials@Liquidia.com","Executive Director, Clinical Operations","(919) 328-4368","Albuquerque, New|Phoenix, Arizona, United States, 85012|Sacramento, California, United States, 95817 Los Angeles Biomedical Research CenterTorrance, California, United States, 90502|Aurora, Colorado, United States, 80045|Gainesville, Florida, United States, 32610|Atlanta, Georgia, United States, 30322 Wellstar Research InstituteMarietta, Georgia, United States, 30060|Chicago, Illinois, United States, 60611|Kansas City, Kansas, United States, 66103|Louisville, Kentucky, United States, 40202|New Orleans, Louisiana, United States, 70121|Mineola, New York, United States, 11501|Chapel Hill, North Carolina, United States, 27599|Cincinnati, Ohio, United States, 45267 Cleveland ClinicCleveland, Ohio, United States, 44195 The Ohio State University Wexner Medical CenterColumbus, Ohio, United States, 43210|Pittsburgh, Pennsylvania, United States, 15212 Upmc Presbyterian HospitalPittsburgh, Pennsylvania, United States, 15213|Houston, Texas, United States, 77030 University Of Texas - Health Science CenterHouston, Texas, United States, 77030|Falls Church, Virginia, United States, 22042","Arizona|California|Colorado|Florida|Georgia|Illinois|Kansas|Kentucky|Louisiana|New York|North Carolina|Ohio|Pennsylvania|Texas|Virginia","Mexico|United States","Health Science Center|Arizona Pulmonary Specialists, Ltd.|Uc Davis Medical Center|University Of Colorado Anschutz Medical Campus|University Of Florida|Emory University School Of Medicine|Northwestern Medicine, Feinberg School Of Medicine|University Of Kansas Medical Center|Kentuckiana Pulmonary Research Center|Ochsner Medical Center|Nyu Winthrop University Hospital|University Of North Carolina School Of Medicine|University Of Cincinnati Medical Center|Alleghany General Hospital|Houston Methodist Lung Center|Inova Fairfax Medical Campus",{"$nulls":4},"2018-06-27","2020-05-25T16:36:49.215","2020-05-26T17:10:42.972","NCT03399604"]
["5ecbf420307e3d1b1f8d9ce8","NCT03399604","2019-06-06","Liquidia Technologies","LQDA","Active, not recruiting","Investigation of the Safety and Pharmacology of Dry Powder Inhalation of Treprostinil (INSPIRE)","Epoprostenol|Treprostinil","PGI2 Agonist|PA Inhibitor|PGI2 Agonist","No",null,"No",null,"Phase 3",1,121,"Actual","2018-01-02","2019-07-31",null,null,"Nuventra, Inc.",null,null,"The primary objective of this study is to evaluate the long-term safety and tolerability of LIQ861, a dry powder formulation of treprostinil, in patients with Pulmonary Arterial Hypertension (PAH). A secondary objective of this study is to evaluate the comparative bioavailability of treprostinil between two formulations of inhaled therapy.","One of the greatest impediments to patient treatment satisfaction with current inhaled treprostinil therapy is inconvenience. Currently, PAH patients using inhaled treprostinil may require more than 36 breaths per day using a nebulizer requiring daily set up and cleaning. The use of a discrete, hand-held dry powder inhaler to deliver treprostinil to the lungs could represent a major improvement in convenience and patient satisfaction, thereby improving the quality of life for PAH patients. Liquidia is pursuing approval of LIQ861, an inhalation dry powder formulation of treprostinil that is produced using Liquidia's PRINTÂ® Technology (Particle Replication in Nonwetting Templates), as an alternative to current inhaled treprostinil therapy for the treatment of patients with PAH (WHO Group 1).","A Phase 3 Open-label, Multicenter Study to Evaluate the Long-term Safety and Tolerability of Inhaled LIQ861(Treprostinil) in Pulmonary Arterial Hypertension (WHO Group 1) Patients","LTI-301","Primary Pulmonary Hypertension","Hypertension|Hypertension, Pulmonary","Vascular Diseases|Lung Diseases","Cardiovascular|Respiratory","Experimental","LIQ861 Inhaled Treprostinil",null,"Drug","LIQ861 Inhaled Treprostinil","LIQ861 bulk powder is generated from a treprostinil/excipient matrix from which particles of precise size and shape are created and filled into a hydroxypropyl methylcellulose (HPMC) capsule (size 3). LIQ861 capsules are provided in capsule strengths of 25 Î¼g, 50 Î¼g, 75 Î¼g and 100 Î¼g treprostinil.","inhaled treprostinil | inhaled prostacyclin","LIQ861 Inhaled Treprostinil","\n\n * signed informed consent by patient prior to study enrollment\n * 18 years of age or older\n * If female of childbearing potential, a negative pregnancy test at the Baseline Visit and agrees to practice adequate birth control throughout the duration of the study. If the patient is postmenopausal or has documented surgical sterilization, a pregnancy test and birth control is not necessary.\n * The patient has been diagnosed with PAH belonging to the following subgroups of the updated Nice Clinical Classification Group 1 (Simonneau, Gatzoulis et al. 2013), which include: 1. Idiopathic PAH (1.1), or\n    2. Heritable PAH (1.2), or\n    3. Drug and toxin induced PAH (1.3), or\n    4. PAH associated with connective tissue disease (1.4.1), HIV infection (1.4.2), or congenital heart disease (1.4.4) with simple systemic-to-pulmonary shunt at least 1 year after surgical repair\n   \n   \n * The patient has been diagnosed with PAH and is NYHA Functional Class II - IV at Screening. 1. has documented stable doses of approved inhaled therapy for at least 3 months prior to screening and is willing and able to transition from their prescribed dose of inhaled therapy to study drug, or\n    2. has documented stable doses of no more than two approved oral therapies for at least 3 months prior to screening and is willing and able to add LIQ861 to their treatment regimen.\n   \n   \n * The patient can complete a baseline six-minute walk distance (6MWD) â‰¥ 150 m.\n * The patient has had evidence of FEV1 â‰¥ 60% and FEV1/FVC ratio â‰¥ 60% during the 6-month period prior to enrollment.\n\n","\n\n * The patient's clinical condition is such that, in the opinion of the Investigator, they are not expected to remain clinically stable for the duration of the study.\n * Patients with PH in the Updated Nice Classification Groups 2-5, or PAH Group 1 subgroups not covered by the inclusion criteria (e.g., associated with portal hypertension [1.4.3] or with schistosomiasis [1.4.5]).\n * The patient is currently taking oral prostacyclin analogues or agonists, including treprostinil and selexipag.\n * The patient has had any PAH medication (except for anticoagulants) discontinued within 14 days of Baseline.\n * The patient has had a new type of chronic therapy (including but not limited to oxygen, a different class of vasodilator, diuretic, digoxin, and digitalis) for pulmonary hypertension added within 30 days of Baseline.\n * The patient has uncontrolled systemic hypertension as evidenced by persistent systolic blood pressure greater than 160 mmHg or diastolic blood pressure greater than 100 mmHg.\n * The patient has a history of hemodynamically significant left-sided heart disease including, but not limited to: aortic or mitral valve disease, pericardial constriction, restrictive or congestive cardiomyopathy, or coronary artery disease (CAD).\n * The patient has had an atrial septostomy.\n * The patient has any serious or life-threatening disease other than conditions associated with PAH (e.g. malignancy requiring aggressive chemotherapy, end stage renal disease, etc.).\n * The patient is taking any excluded medications listed in the Investigator's Brochure, namely inhibitors and inducers of CYP2C8\n * The patient has a hypersensitivity or allergy to any of the ingredients of LIQ861 or other clinically relevant allergies (clinical relevance per Investigator judgment).\n * The patient has had a pulmonary infarction (defined as infarction in more than one lung segment documented by V/Q scan or pulmonary angiography) within two weeks of Screening.\n * The patient has had a stroke or transient ischemic attack (TIA) within six months of Screening.\n * The patient has evidence of an active uncontrolled sepsis or systemic infection during Screening.\n * The patient is pregnant or lactating.\n * The patient has any musculoskeletal disease or any other disease that would limit ambulation.\n * The patient has participated in an investigational product or device study within the 30 days prior to Screening.\n * The patient has current evidence of drug abuse in the opinion of the Investigator.\n * The patient has severe hepatic impairment as evidenced by any history of ascites AND encephalopathy.\n * The patient has severe renal impairment (eGFR < 35).\n * The patient is taking inhaled treprostinil doses of greater than 90 Î¼g (more than 15 breaths).\n\nAdditional Exclusion Criteria for PK Sub-Study:\n\n * The patient meets any of Primary Exclusion Criteria #1 - 19.\n * The patient has moderate or severe renal impairment (eGFR < 60).\n * The patient is taking inhaled treprostinil doses of greater than 72 Î¼g (more than 12 breaths).",{"$nulls":4},"Actual","2018-01-16","Actual","Anticipated","2020-07-31","Anticipated","2019-06-01","2018-01-03","2018-01-12","2019-06-05","No","Pulmonary Arterial Hypertension\nIdiopathic Pulmonary Arterial Hypertension\nHeritable Pulmonary Arterial Hypertension\nDrug Induced Pulmonary Arterial Hypertension\nToxin Induced Pulmonary Arterial Hypertension\nConnective tissue disease","Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No","Undecided",{"$nulls":3},"Yes","No",{"$nulls":19},"Incidence of Treatment-Emergent Adverse Events and Serious Adverse Events","Treatment-Emergent Adverse Events and Serious Adverse Events will be grouped by MedDRA System Organ Class, dose level, time on drug, and relationship to dose titration","Baseline, Week 2, Month 1, Month 2 Visits, with bimonthly follow up for up to 30 months.",{"$nulls":6},"Albuquerque, New|Phoenix, Arizona, United States, 85006 Arizona Pulmonary Specialists, Ltd.Phoenix, Arizona, United States, 85012|Los Angeles, California, United States, 90073 Uc Davis Medical CenterSacramento, California, United States, 95817 Los Angeles Biomedical Research CenterTorrance, California, United States, 90502|Aurora, Colorado, United States, 80045|Gainesville, Florida, United States, 32610 Mayo Clinic-JacksonvilleJacksonville, Florida, United States, 32224 AdventhealthOrlando, Florida, United States, 32803|Atlanta, Georgia, United States, 30322 Wellstar Research InstituteMarietta, Georgia, United States, 30060|Chicago, Illinois, United States, 60611 University Of Chicago MedicineChicago, Illinois, United States, 60637|Kansas City, Kansas, United States, 66103|Louisville, Kentucky, United States, 40202|New Orleans, Louisiana, United States, 70121|Boston, Massachusetts, United States, 02111|Minneapolis, Minnesota, United States, 55435 Mayo Clinic-RochesterRochester, Minnesota, United States, 55905|Saint Louis, Missouri, United States, 63110|Mineola, New York, United States, 11501 Nyu Langone HealthNew York, New York, United States, 10279|Chapel Hill, North Carolina, United States, 27599|Cincinnati, Ohio, United States, 45267 University Hospitals Of Cleveland Medical CenterCleveland, Ohio, United States, 44106 Cleveland ClinicCleveland, Ohio, United States, 44195 The Ohio State University Wexner Medical CenterColumbus, Ohio, United States, 43210|Portland, Oregon, United States, 97239|Philadelphia, Pennsylvania, United States, 19104 Alleghany General HospitalPittsburgh, Pennsylvania, United States, 15212 Upmc Presbyterian HospitalPittsburgh, Pennsylvania, United States, 15213|Dallas, Texas, United States, 75390 Houston Methodist Lung CenterHouston, Texas, United States, 77030 University Of Texas - Health Science CenterHouston, Texas, United States, 77030 University Of Texas Health Science Center At San AntonioSan Antonio, Texas, United States, 78229|Falls Church, Virginia, United States, 22042|Milwaukee, Wisconsin, United States, 53226","Arizona|California|Colorado|Florida|Georgia|Illinois|Kansas|Kentucky|Louisiana|Massachusetts|Minnesota|Missouri|New York|North Carolina|Ohio|Oregon|Pennsylvania|Texas|Virginia|Wisconsin","Mexico|United States","Health Science Center|Banner University Medical Center|West Los Angeles Va Healthcare Center|University Of Colorado Anschutz Medical Campus|University Of Florida|Emory University School Of Medicine|Northwestern Medicine, Feinberg School Of Medicine|University Of Kansas Medical Center|Kentuckiana Pulmonary Research Center|Ochsner Medical Center|Tufts Medical Center|University Of Minnesota|Washington University School Of Medicine|Nyu Winthrop University Hospital|University Of North Carolina School Of Medicine|University Of Cincinnati Medical Center|Oregon Health And Science Center|University Of Pennsylvania Health System|Ut Southwestern Medical Center|Inova Fairfax Medical Campus|The Medical College Of Wisconsin/Froedtert Hospital",{"$nulls":4},"2019-06-05","2020-05-25T16:36:48.909","2020-05-26T17:10:42.972","NCT03399604"]
["5ecbf421e2561b1b11905d53","NCT03399604","2019-09-17","Liquidia Technologies","LQDA","Active, not recruiting","Investigation of the Safety and Pharmacology of Dry Powder Inhalation of Treprostinil (INSPIRE)","Epoprostenol|Treprostinil","PGI2 Agonist|PA Inhibitor|PGI2 Agonist","No",null,"No",null,"Phase 3",1,121,"Actual","2018-01-02","2019-12-31",null,null,"Nuventra, Inc.",null,null,"The primary objective of this study is to evaluate the long-term safety and tolerability of LIQ861, a dry powder formulation of treprostinil, in patients with Pulmonary Arterial Hypertension (PAH). A secondary objective of this study is to evaluate the comparative bioavailability of treprostinil between two formulations of inhaled therapy.","One of the greatest impediments to patient treatment satisfaction with current inhaled treprostinil therapy is inconvenience. Currently, PAH patients using inhaled treprostinil may require more than 36 breaths per day using a nebulizer requiring daily set up and cleaning. The use of a discrete, hand-held dry powder inhaler to deliver treprostinil to the lungs could represent a major improvement in convenience and patient satisfaction, thereby improving the quality of life for PAH patients. Liquidia is pursuing approval of LIQ861, an inhalation dry powder formulation of treprostinil that is produced using Liquidia's PRINTÂ® Technology (Particle Replication in Nonwetting Templates), as an alternative to current inhaled treprostinil therapy for the treatment of patients with PAH (WHO Group 1).","A Phase 3 Open-label, Multicenter Study to Evaluate the Long-term Safety and Tolerability of Inhaled LIQ861(Treprostinil) in Pulmonary Arterial Hypertension (WHO Group 1) Patients","LTI-301","Primary Pulmonary Hypertension","Hypertension|Hypertension, Pulmonary","Vascular Diseases|Lung Diseases","Cardiovascular|Respiratory","Experimental","LIQ861 Inhaled Treprostinil",null,"Drug","LIQ861 Inhaled Treprostinil","LIQ861 bulk powder is generated from a treprostinil/excipient matrix from which particles of precise size and shape are created and filled into a hydroxypropyl methylcellulose (HPMC) capsule (size 3). LIQ861 capsules are provided in capsule strengths of 25 Î¼g, 50 Î¼g, 75 Î¼g and 100 Î¼g treprostinil.","inhaled treprostinil | inhaled prostacyclin","LIQ861 Inhaled Treprostinil","\n\n * signed informed consent by patient prior to study enrollment\n * 18 years of age or older\n * If female of childbearing potential, a negative pregnancy test at the Baseline Visit and agrees to practice adequate birth control throughout the duration of the study. If the patient is postmenopausal or has documented surgical sterilization, a pregnancy test and birth control is not necessary.\n * The patient has been diagnosed with PAH belonging to the following subgroups of the updated Nice Clinical Classification Group 1 (Simonneau, Gatzoulis et al. 2013), which include: 1. Idiopathic PAH (1.1), or\n    2. Heritable PAH (1.2), or\n    3. Drug and toxin induced PAH (1.3), or\n    4. PAH associated with connective tissue disease (1.4.1), HIV infection (1.4.2), or congenital heart disease (1.4.4) with simple systemic-to-pulmonary shunt at least 1 year after surgical repair\n   \n   \n * The patient has been diagnosed with PAH and is NYHA Functional Class II - IV at Screening. 1. has documented stable doses of approved inhaled therapy for at least 3 months prior to screening and is willing and able to transition from their prescribed dose of inhaled therapy to study drug, or\n    2. has documented stable doses of no more than two approved oral therapies for at least 3 months prior to screening and is willing and able to add LIQ861 to their treatment regimen.\n   \n   \n * The patient can complete a baseline six-minute walk distance (6MWD) â‰¥ 150 m.\n * The patient has had evidence of FEV1 â‰¥ 60% and FEV1/FVC ratio â‰¥ 60% during the 6-month period prior to enrollment.\n\n","\n\n * The patient's clinical condition is such that, in the opinion of the Investigator, they are not expected to remain clinically stable for the duration of the study.\n * Patients with PH in the Updated Nice Classification Groups 2-5, or PAH Group 1 subgroups not covered by the inclusion criteria (e.g., associated with portal hypertension [1.4.3] or with schistosomiasis [1.4.5]).\n * The patient is currently taking oral prostacyclin analogues or agonists, including treprostinil and selexipag.\n * The patient has had any PAH medication (except for anticoagulants) discontinued within 14 days of Baseline.\n * The patient has had a new type of chronic therapy (including but not limited to oxygen, a different class of vasodilator, diuretic, digoxin, and digitalis) for pulmonary hypertension added within 30 days of Baseline.\n * The patient has uncontrolled systemic hypertension as evidenced by persistent systolic blood pressure greater than 160 mmHg or diastolic blood pressure greater than 100 mmHg.\n * The patient has a history of hemodynamically significant left-sided heart disease including, but not limited to: aortic or mitral valve disease, pericardial constriction, restrictive or congestive cardiomyopathy, or coronary artery disease (CAD).\n * The patient has had an atrial septostomy.\n * The patient has any serious or life-threatening disease other than conditions associated with PAH (e.g. malignancy requiring aggressive chemotherapy, end stage renal disease, etc.).\n * The patient is taking any excluded medications listed in the Investigator's Brochure, namely inhibitors and inducers of CYP2C8\n * The patient has a hypersensitivity or allergy to any of the ingredients of LIQ861 or other clinically relevant allergies (clinical relevance per Investigator judgment).\n * The patient has had a pulmonary infarction (defined as infarction in more than one lung segment documented by V/Q scan or pulmonary angiography) within two weeks of Screening.\n * The patient has had a stroke or transient ischemic attack (TIA) within six months of Screening.\n * The patient has evidence of an active uncontrolled sepsis or systemic infection during Screening.\n * The patient is pregnant or lactating.\n * The patient has any musculoskeletal disease or any other disease that would limit ambulation.\n * The patient has participated in an investigational product or device study within the 30 days prior to Screening.\n * The patient has current evidence of drug abuse in the opinion of the Investigator.\n * The patient has severe hepatic impairment as evidenced by any history of ascites AND encephalopathy.\n * The patient has severe renal impairment (eGFR < 35).\n * The patient is taking inhaled treprostinil doses of greater than 90 Î¼g (more than 15 breaths).\n\nAdditional Exclusion Criteria for PK Sub-Study:\n\n * The patient meets any of Primary Exclusion Criteria #1 - 19.\n * The patient has moderate or severe renal impairment (eGFR < 60).\n * The patient is taking inhaled treprostinil doses of greater than 72 Î¼g (more than 12 breaths).",{"$nulls":4},"Actual","2018-01-16","Actual","Anticipated","2020-07-31","Anticipated","2019-09-01","2018-01-03","2018-01-12","2019-09-16","No","Pulmonary Arterial Hypertension\nIdiopathic Pulmonary Arterial Hypertension\nHeritable Pulmonary Arterial Hypertension\nDrug Induced Pulmonary Arterial Hypertension\nToxin Induced Pulmonary Arterial Hypertension\nConnective tissue disease","Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No","Undecided",{"$nulls":3},"Yes","No",{"$nulls":19},"Incidence of Treatment-Emergent Adverse Events and Serious Adverse Events","Treatment-Emergent Adverse Events and Serious Adverse Events will be grouped by MedDRA System Organ Class, dose level, time on drug, and relationship to dose titration","Baseline, Week 2, Month 1, Month 2 Visits, with bimonthly follow up for up to 30 months.",{"$nulls":6},"Albuquerque, New|Phoenix, Arizona, United States, 85006 Arizona Pulmonary Specialists, Ltd.Phoenix, Arizona, United States, 85012|Los Angeles, California, United States, 90073 Uc Davis Medical CenterSacramento, California, United States, 95817 Los Angeles Biomedical Research CenterTorrance, California, United States, 90502|Aurora, Colorado, United States, 80045|Gainesville, Florida, United States, 32610 Mayo Clinic-JacksonvilleJacksonville, Florida, United States, 32224 AdventhealthOrlando, Florida, United States, 32803|Atlanta, Georgia, United States, 30322 Wellstar Research InstituteMarietta, Georgia, United States, 30060|Chicago, Illinois, United States, 60611 University Of Chicago MedicineChicago, Illinois, United States, 60637|Kansas City, Kansas, United States, 66103|Louisville, Kentucky, United States, 40202|New Orleans, Louisiana, United States, 70121|Boston, Massachusetts, United States, 02111|Minneapolis, Minnesota, United States, 55435 Mayo Clinic-RochesterRochester, Minnesota, United States, 55905|Saint Louis, Missouri, United States, 63110|Mineola, New York, United States, 11501 Nyu Langone HealthNew York, New York, United States, 10279|Chapel Hill, North Carolina, United States, 27599|Cincinnati, Ohio, United States, 45267 University Hospitals Of Cleveland Medical CenterCleveland, Ohio, United States, 44106 Cleveland ClinicCleveland, Ohio, United States, 44195 The Ohio State University Wexner Medical CenterColumbus, Ohio, United States, 43210|Portland, Oregon, United States, 97239|Philadelphia, Pennsylvania, United States, 19104 Alleghany General HospitalPittsburgh, Pennsylvania, United States, 15212 Upmc Presbyterian HospitalPittsburgh, Pennsylvania, United States, 15213|Dallas, Texas, United States, 75390 Houston Methodist Lung CenterHouston, Texas, United States, 77030 University Of Texas - Health Science CenterHouston, Texas, United States, 77030 University Of Texas Health Science Center At San AntonioSan Antonio, Texas, United States, 78229|Falls Church, Virginia, United States, 22042|Milwaukee, Wisconsin, United States, 53226","Arizona|California|Colorado|Florida|Georgia|Illinois|Kansas|Kentucky|Louisiana|Massachusetts|Minnesota|Missouri|New York|North Carolina|Ohio|Oregon|Pennsylvania|Texas|Virginia|Wisconsin","Mexico|United States","Health Science Center|Banner University Medical Center|West Los Angeles Va Healthcare Center|University Of Colorado Anschutz Medical Campus|University Of Florida|Emory University School Of Medicine|Northwestern Medicine, Feinberg School Of Medicine|University Of Kansas Medical Center|Kentuckiana Pulmonary Research Center|Ochsner Medical Center|Tufts Medical Center|University Of Minnesota|Washington University School Of Medicine|Nyu Winthrop University Hospital|University Of North Carolina School Of Medicine|University Of Cincinnati Medical Center|Oregon Health And Science Center|University Of Pennsylvania Health System|Ut Southwestern Medical Center|Inova Fairfax Medical Campus|The Medical College Of Wisconsin/Froedtert Hospital",{"$nulls":4},"2019-09-16","2020-05-25T16:36:49.318","2020-05-26T17:10:42.972","NCT03399604"]
["5ecbf423fe30261b1a04825c","NCT03399734","2018-10-29","Eisai","ESALY","Completed","Bioequivalence Study Between a 4-mg Dose of Fine Granules of Perampanel and a 4-mg Tablet of Perampanel in Healthy Japanese Subjects","Perampanel","AMPA Antagonist","No",null,"No",null,"Phase 1",2,24,"Actual","2017-12-18","2018-03-09","AUC","Area Under The Curve",{"$nulls":3},"This study will be conducted to demonstrate the bioequivalence between a single 4 milligram (mg) dose of fine granules of perampanel and a single 4 mg tablet of perampanel.",null,"A Randomized, Open-Label, Crossover Study to Demonstrate Bioequivalence Between a 4-mg Dose of Fine Granules of Perampanel and a 4-mg Tablet of Perampanel in Healthy Japanese Subjects","E2007-J081-053","Healthy Participants","Healthy Volunteers","Healthy","Healthy","Experimental","Treatment A|Treatment B","4 milligrams (mg) perampanel tablet|4 mg perampanel fine granules","Drug","Perampanel","Single oral dose of 1 x 4-mg perampanel tablet|Single 4-mg dose of perampanel fine granules","E2007","Treatment A|Treatment B","Participants must meet all of the following criteria to be included in this study:\n\n * Non-smoking, male or female age â‰¥20 years and â‰¤45 years old at the time of obtaining written informed consent. To be considered non-smokers, participants must have discontinued smoking from Screening before first dosing.\n * Body Mass Index â‰¥18.5 and <25.0 kilograms per meters squared at Screening\n\n","Participants who meet any of the following criteria will be excluded from this study:\n\n * Females who are breastfeeding or pregnant at Screening or Baseline\n * Clinically significant illness that requires medical treatment within 8 weeks or a clinically significant infection that requires medical treatment within 4 weeks before first dosing\n * Evidence of disease that may influence the outcome of the study within 4 weeks before first dosing\n * Any history of gastrointestinal surgery that may affect pharmacokinetic profiles of perampanel at Screening\n * Any clinically abnormal symptom or organ impairment found by medical history at Screening, and physical examinations, vital signs, electrocardiogram (ECG) finding, or laboratory test results that require medical treatment at Screening\n * A prolonged QT/QT corrected interval (QT interval, Fridericia correction >450 milliseconds) as demonstrated by a repeated ECG at Screening or Baseline ",{"$nulls":4},"Actual","2018-01-16","Actual","Actual","2018-03-09","Actual","2018-01-01","2018-01-08","2018-01-09","2018-10-26","No","Perampanel\nBioequivalence\nfine granules\nE2007\nJapanese","Interventional","Basic Science","Crossover Assignment","None (Open Label)","Randomized","20 Years","45 Years","All",null,"Yes",{"$nulls":4},"No","No",{"$nulls":4},"No",{"$nulls":14},"Maximum observed concentration (Cmax)|Area under the concentration-time curve from zero time to 168 hours (AUC[0-168h])","0-168 hours postdose of Treatment Period 1 and Treatment Period 2",null,"Time at which the highest drug concentration occurs (tmax)|Lag time (tlag)|Area under the concentration-time curve from zero time to 72 hours (AUC[0-72h])|Area under the concentration-time curve from zero time to time of the last quantifiable concentration (AUC[0-t])|Area under the concentration-time curve from zero time extrapolated to infinite time (AUC[0-inf])|Terminal phase rate constant (Î»z)|Terminal elimination phase half-life (t1/2)|Mean residence time (MRT)","0-168 hours postdose of Treatment Period 1 and Treatment Period 2|tlag is the time delay between drug administration and the onset of drug absorption.|0-72 hours postdose of Treatment Period 1 and Treatment Period 2","0-168 hours postdose of Treatment Period 1 and Treatment Period 2",{"$nulls":3},"Toshima-Ku, Tokyo, Japan",null,"Japan","Tokyo Eisai Trial Site",{"$nulls":4},"2018-10-26","2020-05-25T16:36:51.556","2020-05-26T17:10:42.972","NCT03399734"]
["5ecbf424307e3d1b1f8d9cee","NCT03399786","2018-05-16","Regeneron","REGN","Recruiting","Efficacy and Safety of Evinacumab in Patients With Homozygous Familial Hypercholesterolemia","Evinacumab",null,"Yes","['Evinacumab']","Unknown",null,"Phase 3",2,57,"Anticipated","2018-01-18","2020-04-05",{"$nulls":5},"The primary objective of the study is to demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by evinacumab intravenously (IV) in comparison to placebo after 24 weeks in patients with homozygous familial hypercholesterolemia (HoFH). The secondary objectives of the study are to evaluate the effect of evinacumab IV on other lipid parameters, evaluate the effect of evinacumab on LDL-C goal attainment, assess the effect of evinacumab on eligibility for apheresis (using German and US apheresis criteria), evaluate the safety and tolerability of evinacumab in patients with HoFH, assess the pharmacokinetics (PK) of evinacumab in patients with HoFH and evaluate the potential development of anti-evinacumab antibodies.",null,"A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Evinacumab in Patients With Homozygous Familial Hypercholesterolemia","R1500-CL-1629","Homozygous Familial Hypercholesterolemia","Hypercholesterolemia","Metabolic Diseases","Nutritional Disorders","Experimental","evinacumab|Placebo",null,"Drug","evinacumab|Placebo","IV administration of evinacumab|IV administration of placebo","REGN1500","evinacumab|Placebo","\n\n 1. Diagnosis of functional HoFH\n 2. If undergoing LDL apheresis, must have initiated LDL apheresis at least 3 months prior to screening and must have been on a stable weekly or every other week schedule and/or stable settings for at least 8 weeks\n 3. Willing to consistently maintain his/her usual low fat or heart-healthy diet for the duration of the study\n\nKey ","\n\n 1.  LDL-C level <70 mg/dL (1.81 mmol/L) at the screening visit\n 2.  Background medical Lipid Modifying Therapy (LMT) (if applicable) that has not been stable before the screening visit\n 3.  Lipid-apheresis schedule /apheresis settings (if applicable) that have not been stable for at least 8 weeks before the screening visit\n 4.  Use of nutraceuticals or over-the-counter therapies known to affect lipids, at a dose/amount that has not been stable for at least 4 weeks prior to the screening visit\n 5.  Presence of any clinically significant uncontrolled endocrine disease known to influence serum lipids or lipoproteins\n 6.  Newly diagnosed (within 3 months prior to randomization visit) diabetes mellitus or poorly controlled (HbA1c >9%) diabetes\n 7.  History of a MI, unstable angina leading to hospitalization, coronary artery bypass graft surgery, percutaneous coronary intervention, uncontrolled cardiac arrhythmia, carotid surgery or stenting, stroke, transient ischemic attack, valve replacement surgery, carotid revascularization, endovascular procedure or surgical intervention for peripheral vascular disease within 3 months prior to the screening visit\n 8.  Pregnant or breastfeeding women\n 9.  Sexually active women of child bearing potential (WOCBP), who are unwilling to practice a highly effective birth control method prior to the initial dose, during the study, and for 24 weeks after the last dose of study drug\n 10. Sexually active men who are unwilling to use forms of medically acceptable birth control during the study drug treatment period and for 24 weeks after the last dose of study drug\n\nNote: Other protocol defined inclusion/exclusion criteria may apply.",{"$nulls":4},"Actual","2018-01-16","Actual","Anticipated","2020-04-05","Anticipated","2018-05-01","2018-01-08","2018-01-08","2018-05-11","Yes","HoFH","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"2017-001388-19","EudraCT Number","Percent change in calculated LDL-C from baseline to week 24","Week 24",null,"Percent change in Apolipoprotein B (Apo B) from baseline to week 24|Percent change in non-High-density lipoprotein cholesterol (HDL-C) from baseline to week 24|Percent change in Total cholesterol (TC) from baseline to week 24|Proportion of patients with â‰¥30% reduction in calculated LDL-C|Proportion of patients with â‰¥50% reduction in calculated LDL-C|Proportion of patients with LDL-C <100 mg/dL [2.59 mmol/L]|Change in calculated LDL-C from baseline to week 24|Proportion of patients who meet European Union (EU) apheresis eligibility criteria (see German Apheresis Working Group)|Proportion of patients who meet United States (US) apheresis eligibility criteria (see US [National Lipid Association] Lipid Apheresis Criteria)|Percent change in Triglyceride (TG) from baseline to week 24|Change in Apo B from baseline to week 24|Change in non-HDL-C from baseline to week 24|Change in TC from baseline to week 24|Percent change in lipoprotein a [Lp(a)] from baseline to week 24|Proportion of patients with LDL-C <70 mg/dL [1.81 mmol/L]|Percent change in apolipoprotein CIII (Apo CIII) from baseline to week 24|Total evinacumab concentration in serum|Incidence of anti-drug antibody (ADA)","Week 24",null,"clinicaltrials@regeneron.com","Clinical Trials Administrator","844-734-6643","Camperdown, New South Wales, Australia, 2050|Perth, Western|Innsbruck, Austria, 6020|Chicoutimi, Quebec, Canada, G7H 7K9 Regeneron Research SiteQuÃ©bec, Quebec, Canada, G1V 4W2|Praha, Czechia, 121 08|Paris, Cedex, France, 75651|Marseille, France, 13385|Berlin, Germany, 12203|IoÃ¡nnina, Ioannina, Greece, 45500|Athens, Greece, 17674|Napoli, Italy, 80131 Regeneron Research Site # 2Napoli, Italy, 80131 Regeneron Research SiteRoma, Italy, 00161|Kurume, Fukuoka, Japan, 830-8522|Nishinomiya, Hyogo, Japan, 662-0918|Kanazawa, Ishikawa, Japan, 920-8641|Suita, Osaka, Japan, 565-8565|Osaka, Japan, 530-0001|Amsterdam, Netherlands, 1105 Az Regeneron Research SiteRotterdam, Netherlands, 3045 Pm|Parktown, Johannesburg, South Africa, 2000|Cape Town, Western, South Africa, 7925|Ankara, Turkey, 6500 Regeneron Research SiteIstanbul, Turkey, 34746 Regeneron Research SiteIÌ‡Zmir, Turkey, 35040|Ivano-Frankivs'K, Ukraine, 76075 Regeneron Research SiteKharkiv, Ukraine, 61039 Regeneron Research SiteKharkiv, Ukraine, 61176 Regeneron Research SiteKyiv, Ukraine, 02660 Regeneron Research SiteKyiv, Ukraine, 03680|Boca Raton, Florida, United States, 33434|New York, New York, United States, 10021 Regeneron Research SiteNew York, New York, United States, 10029|Portland, Oregon, United States, 97239|[Active, Not Recruiting]Philadelphia, Pennsylvania, United States, 19104|Dallas, Texas, United States, 78226","Florida|New York|Oregon|Pennsylvania|Texas","Australia|Austria|Canada|Czechia|France|Germany|Greece|Italy|Japan|Netherlands|South Africa|Turkey|Ukraine|United States","New South Wales Regeneron Research Site|Regeneron Research Site|Quebec Regeneron Research Site|Cedex Regeneron Research Site|Ioannina Regeneron Research Site|Regeneron Research Site # 1|Fukuoka Regeneron Research Site|Hyogo Regeneron Research Site|Ishikawa Regeneron Research Site|Osaka Regeneron Research Site|, Johannesburg Regeneron Research Site|, Western Regeneron Research Site",{"$nulls":3},"Clinical Trial Management","2018-05-11","2020-05-25T16:36:52.368","2020-05-26T17:10:42.972","NCT03399786"]
["5ecbf424307e3d1b1f8d9cef","NCT03399786","2020-04-30","Regeneron","REGN","Completed","Efficacy and Safety of Evinacumab in Patients With Homozygous Familial Hypercholesterolemia","Evinacumab",null,"Yes","['Evinacumab']","Unknown",null,"Phase 3",2,65,"Actual","2018-01-18","2019-06-10",{"$nulls":5},"The primary objective of the study is to demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by evinacumab intravenously (IV) in comparison to placebo after 24 weeks in patients with homozygous familial hypercholesterolemia (HoFH). The secondary objectives of the study are to evaluate the effect of evinacumab IV on other lipid parameters, evaluate the effect of evinacumab on LDL-C goal attainment, assess the effect of evinacumab on eligibility for apheresis (using German and US apheresis criteria), evaluate the safety and tolerability of evinacumab in patients with HoFH, assess the pharmacokinetics (PK) of evinacumab in patients with HoFH and evaluate the potential development of anti-evinacumab antibodies.",null,"A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Evinacumab in Patients With Homozygous Familial Hypercholesterolemia","R1500-CL-1629","Homozygous Familial Hypercholesterolemia","Hypercholesterolemia","Metabolic Diseases","Nutritional Disorders","Experimental","evinacumab|Placebo",null,"Drug","evinacumab|Placebo","IV administration of evinacumab|IV administration of placebo","REGN1500","evinacumab|Placebo","\n\n 1. Diagnosis of functional HoFH\n 2. If undergoing LDL apheresis, must have initiated LDL apheresis at least 3 months prior to screening and must have been on a stable weekly or every other week schedule and/or stable settings for at least 8 weeks\n 3. Willing to consistently maintain his/her usual low fat or heart-healthy diet for the duration of the study\n\nKey ","\n\n 1.  LDL-C level <70 mg/dL (1.81 mmol/L) at the screening visit\n 2.  Background medical Lipid Modifying Therapy (LMT) (if applicable) that has not been stable before the screening visit\n 3.  Lipid-apheresis schedule /apheresis settings (if applicable) that have not been stable for at least 8 weeks before the screening visit\n 4.  Use of nutraceuticals or over-the-counter therapies known to affect lipids, at a dose/amount that has not been stable for at least 4 weeks prior to the screening visit\n 5.  Presence of any clinically significant uncontrolled endocrine disease known to influence serum lipids or lipoproteins\n 6.  Newly diagnosed (within 3 months prior to randomization visit) diabetes mellitus or poorly controlled (HbA1c >9%) diabetes\n 7.  History of a MI, unstable angina leading to hospitalization, coronary artery bypass graft surgery, percutaneous coronary intervention, uncontrolled cardiac arrhythmia, carotid surgery or stenting, stroke, transient ischemic attack, valve replacement surgery, carotid revascularization, endovascular procedure or surgical intervention for peripheral vascular disease within 3 months prior to the screening visit\n 8.  Pregnant or breastfeeding women\n 9.  Sexually active women of child bearing potential (WOCBP), who are unwilling to practice a highly effective birth control method prior to the initial dose, during the study, and for 24 weeks after the last dose of study drug\n 10. Men who are sexually active with women of child bearing potential (WOCBP) and are unwilling to consistently use condoms during the study drug treatment period and for 24 weeks after the last dose of study drug regardless of vasectomy status\n\nNote: Other protocol defined inclusion/exclusion criteria may apply.",{"$nulls":4},"Actual","2018-01-16","Actual","Actual","2020-03-17","Actual","2020-04-01","2018-01-08","2018-01-08","2020-04-28","Yes","HoFH","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","12 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"2017-001388-19","EudraCT Number","Percent change in calculated LDL-C from baseline to week 24","Week 24",null,"Percent change in Apolipoprotein B (Apo B) from baseline to week 24|Percent change in non-High-density lipoprotein cholesterol (HDL-C) from baseline to week 24|Percent change in Total cholesterol (TC) from baseline to week 24|Proportion of patients with â‰¥30% reduction in calculated LDL-C|Proportion of patients with â‰¥50% reduction in calculated LDL-C|Proportion of patients with LDL-C <100 mg/dL [2.59 mmol/L]|Change in calculated LDL-C from baseline to week 24|Proportion of patients who meet European Union (EU) apheresis eligibility criteria (see German Apheresis Working Group)|Proportion of patients who meet United States (US) apheresis eligibility criteria (see US [National Lipid Association] Lipid Apheresis Criteria)|Percent change in Triglyceride (TG) from baseline to week 24|Change in Apo B from baseline to week 24|Change in non-HDL-C from baseline to week 24|Change in TC from baseline to week 24|Percent change in lipoprotein a [Lp(a)] from baseline to week 24|Proportion of patients with LDL-C <70 mg/dL [1.81 mmol/L]|Percent change in apolipoprotein CIII (Apo CIII) from baseline to week 24|Total evinacumab concentration in serum|Incidence of anti-drug antibody (ADA)","Week 24",{"$nulls":4},"Camperdown, New South Wales, Australia, 2050|Perth, Western|Innsbruck, Austria, 6020|Chicoutimi, Quebec, Canada, G7H 7K9 Regeneron Research SiteQuÃ©bec, Quebec, Canada, G1V 4W2|Paris, Cedex, France, 75651|Marseille, France, 13385|IoÃ¡nnina, Ioannina, Greece, 45500|Athens, Greece, 17674|Napoli, Italy, 80131|Kurume, Fukuoka, Japan, 830-8522|Nishinomiya, Hyogo, Japan, 662-0918|Kanazawa, Ishikawa, Japan, 920-8641|Suita, Osaka, Japan, 565-0871 Regeneron Research SiteSuita, Osaka, Japan, 565-8565|Osaka, Japan, 530-0001|Amsterdam, Netherlands, 1105 Az Regeneron Research SiteRotterdam, Netherlands, 3045 Pm|Parktown, Johannesburg, South Africa, 2000|Ivano-Frankivs'K, Ukraine, 76075 Regeneron Research SiteKharkiv, Ukraine, 61039 Regeneron Research Site #2Kharkiv, Ukraine, 61176 Regeneron Research Site #2Kyiv, Ukraine, 02660 Regeneron Research SiteKyiv, Ukraine, 03680|Boca Raton, Florida, United States, 33434|Boston, Massachusetts, United States, 02114|New York, New York, United States, 10029|Cincinnati, Ohio, United States, 45227|Portland, Oregon, United States, 97239|Dallas, Texas, United States, 78226","Florida|Massachusetts|New York|Ohio|Oregon|Texas","Australia|Austria|Canada|France|Greece|Italy|Japan|Netherlands|South Africa|Ukraine|United States","New South Wales Regeneron Research Site|Regeneron Research Site|Quebec Regeneron Research Site|Cedex Regeneron Research Site|Ioannina Regeneron Research Site|Regeneron Research Site # 2|Fukuoka Regeneron Research Site|Hyogo Regeneron Research Site|Ishikawa Regeneron Research Site|Osaka Regeneron Research Site #3|, Johannesburg Regeneron Research Site",{"$nulls":3},"Clinical Trial Management","2020-04-28","2020-05-25T16:36:52.807","2020-05-26T17:10:42.972","NCT03399786"]
["5ecbf424e2561b1b11905d59","NCT03399799","2018-01-16","Johnson & Johnson","JNJ","Recruiting","Dose Escalation Study of JNJ-64407564 in Participants With Relapsed or Refractory Multiple Myeloma","Jnj-64407564","CD3 Inhibitor","Yes","['Jnj-64407564']","Yes","['CD3 Inhibitor']","Phase 1",1,60,"Anticipated","2017-12-16","2020-10-14","DLT","Dose Limiting Toxicity",{"$nulls":3},"The purpose of this study is to characterize the safety of JNJ-64407564 and to determine the recommended Phase 2 dose(s) (RP2Ds) and dosing schedule assessed to be safe for JNJ-64407564.","The study will evaluate safety, tolerability, pharmacokinetics and preliminary antitumor activity of JNJ-64407564 administered to adult participants with relapsed or refractory multiple myeloma. The overall safety of the study drug will be assessed by physical examinations, Eastern Cooperative Oncology Group performance status, laboratory tests, vital signs, electrocardiograms, adverse event monitoring, and concomitant medication usage. Disease evaluations will include peripheral blood and bone marrow assessments at screening (performed within 28 days) and to confirm stringent complete response (sCR), complete response (CR), or relapse from CR. The end of study (study completion) is defined as the last study assessment for the last participant in the study.","A Phase 1, First-in-Human, Open-Label, Dose Escalation Study of JNJ-64407564, a Humanized DuoBodyÂ® Antibody, in Subjects With Relapsed or Refractory Multiple Myeloma","CR108404","Hematological Malignancies","Oncology Hematological Unspecified","Oncology Hematological","Oncology","Experimental","Dose Escalation (JNJ-64407564)","Participants will receive intravenous (IV) infusion of JNJ-64407564 at minimum anticipated biologic effect level (MABEL)-based starting dose until the completion of the end of treatment visit. Subsequent dose levels will be selected based on the review of all available data including, but not limited to, pharmacokinetic, pharmacodynamic, safety, and preliminary antitumor activity data.","Drug","JNJ-64407564","Participants will receive IV infusion of JNJ-64407564.",null,"Dose Escalation (JNJ-64407564)","\n\n * Documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria\n * Participants with measurable multiple myeloma who have progressed on, or could not tolerate, all available established therapies\n * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1\n * Women of childbearing potential must have a negative pregnancy test at screening and prior to the first dose of study drug using a highly sensitive pregnancy test either serum (Beta human chorionic gonadotropin [beta-hCG]) or urine\n * Sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study, and is willing to and able participate in the study. Consent is to be obtained prior to the initiation of any study-related tests or procedures that are not part of standard-of-care for the participant's disease\n\n","\n\n * Vaccinated with live, attenuated vaccine within 4 weeks or as recommended by the product manufacturer prior to the first dose, during treatment, or within 100 days of the last dose of JNJ-64407564\n * Toxicities from previous anticancer therapies should have resolved to baseline levels or to Grade 1 or less except for alopecia or peripheral neuropathy\n * Received a cumulative dose of corticosteroids equivalent to greater than or equal to ( >=) 140 milligram (mg) of prednisone within the 14-day period before the first dose of study drug\n * Stem cell transplantation: Previously received an allogenic stem cell transplant; and/or received an autologous stem cell transplant less than or equal to (<=) 12 weeks before the first dose of study drug\n * Documented history of central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma. If either is suspected, whole body magnetic resonance imaging (MRI) and lumbar cytology are required",{"$nulls":4},"Actual","2018-01-16","Actual","Anticipated","2020-10-14","Anticipated","2018-01-01","2017-12-22","2018-01-08","2018-01-08","No",null,"Interventional","Treatment","Sequential Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No",null,null,"URL: http://pam.sylogent.com/cr/CR108404 [http://pam.sylogent.com/cr/CR108404] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To learn how to participate in this trial please click here.",null,"Yes","No",{"$nulls":17},"2017-002400-26|64407564MMY1001","EudraCT Number|Janssen Research & Development, LLC","Dose-limiting Toxicity (DLT)|Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability","The Dose Limiting Toxicities (DLTs) are based on drug related adverse events and defined as any of the following events: hematological / non-hematological toxicity of Grade 3 or higher.|An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.","Up to Day 28|From signing of Informed Consent Form (ICF) up to follow up (until 100 days after the last dose of study drug or until the start of subsequent anticancer therapy, if earlier)","JNJ-64407564 Serum Concentrations|Biomarker Assessment|Number of Participants with JNJ-64407564 Antibodies","Serum concentrations will be calculated for JNJ-64407564.|Serum cytokine concentrations will be measured pre- and post-infusion of JNJ-64407564 for biomarker assessment.|Antibodies to JNJ-64407564 will be assessed to evaluate potential immunogenicity.","Up to 8 weeks|Up to Cycle 7, Day 1","JNJ.CT@sylogent.com","Study Contact","844-434-4210","Duarte, California, United States, 91010|Aurora, Colorado, United States, 80045|New York, New York, United States, 10029|Nashville, Tennessee, United States, 37203","California|Colorado|New York|Tennessee","United States","City Of Hope|University Of Colorado Cancer Center|Mount Sinai Medical Center|Sarah Cannon Research Institute",{"$nulls":3},"Janssen Research & Development, LLC Clinical Trial","2018-01-08","2020-05-25T16:36:52.790","2020-05-26T17:10:42.972","NCT03399799"]
["5ecbf424fe30261b1a04825f","NCT03399799","2018-03-30","Johnson & Johnson","JNJ","Recruiting","Dose Escalation Study of JNJ-64407564 in Participants With Relapsed or Refractory Multiple Myeloma","Jnj-64407564","CD3 Inhibitor","Yes","['Jnj-64407564']","Yes","['CD3 Inhibitor']","Phase 1",1,60,"Anticipated","2017-12-16","2020-10-14","DLT","Dose Limiting Toxicity",{"$nulls":3},"The purpose of this study is to characterize the safety of JNJ-64407564 and to determine the recommended Phase 2 dose(s) (RP2Ds) and dosing schedule assessed to be safe for JNJ-64407564.","The study will evaluate safety, tolerability, pharmacokinetics and preliminary antitumor activity of JNJ-64407564 administered to adult participants with relapsed or refractory multiple myeloma. The overall safety of the study drug will be assessed by physical examinations, Eastern Cooperative Oncology Group performance status, laboratory tests, vital signs, electrocardiograms, adverse event monitoring, and concomitant medication usage. Disease evaluations will include peripheral blood and bone marrow assessments at screening (performed within 28 days) and to confirm stringent complete response (sCR), complete response (CR), or relapse from CR. The end of study (study completion) is defined as the last study assessment for the last participant in the study.","A Phase 1, First-in-Human, Open-Label, Dose Escalation Study of JNJ-64407564, a Humanized DuoBodyÂ® Antibody, in Subjects With Relapsed or Refractory Multiple Myeloma","CR108404","Hematological Malignancies","Oncology Hematological Unspecified","Oncology Hematological","Oncology","Experimental","Dose Escalation (JNJ-64407564)","Participants will receive intravenous (IV) infusion of JNJ-64407564 at minimum anticipated biologic effect level (MABEL)-based starting dose until the completion of the end of treatment visit. Subsequent dose levels will be selected based on the review of all available data including, but not limited to, pharmacokinetic, pharmacodynamic, safety, and preliminary antitumor activity data.","Drug","JNJ-64407564","Participants will receive IV infusion of JNJ-64407564.",null,"Dose Escalation (JNJ-64407564)","\n\n * Documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria\n * Participants with measurable multiple myeloma who have progressed on, or could not tolerate, all available established therapies\n * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1\n * Women of childbearing potential must have a negative pregnancy test at screening and prior to the first dose of study drug using a highly sensitive pregnancy test either serum (Beta human chorionic gonadotropin [beta-hCG]) or urine\n * Sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study, and is willing to and able participate in the study. Consent is to be obtained prior to the initiation of any study-related tests or procedures that are not part of standard-of-care for the participant's disease\n\n","\n\n * Vaccinated with live, attenuated vaccine within 4 weeks or as recommended by the product manufacturer prior to the first dose, during treatment, or within 100 days of the last dose of JNJ-64407564\n * Toxicities from previous anticancer therapies should have resolved to baseline levels or to Grade 1 or less except for alopecia or peripheral neuropathy\n * Received a cumulative dose of corticosteroids equivalent to greater than or equal to ( >=) 140 milligram (mg) of prednisone within the 14-day period before the first dose of study drug\n * Stem cell transplantation: Previously received an allogenic stem cell transplant; and/or received an autologous stem cell transplant less than or equal to (<=) 12 weeks before the first dose of study drug\n * Documented history of central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma. If either is suspected, whole body magnetic resonance imaging (MRI) and lumbar cytology are required",{"$nulls":4},"Actual","2018-01-16","Actual","Anticipated","2020-10-14","Anticipated","2018-03-01","2017-12-22","2018-01-08","2018-03-29","No",null,"Interventional","Treatment","Sequential Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No",null,null,"URL: http://pam.sylogent.com/cr/CR108404 [http://pam.sylogent.com/cr/CR108404] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To learn how to participate in this trial please click here.",null,"Yes","No",{"$nulls":17},"2017-002400-26|64407564MMY1001","EudraCT Number|Janssen Research & Development, LLC","Dose-limiting Toxicity (DLT)|Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability","The Dose Limiting Toxicities (DLTs) are based on drug related adverse events and defined as any of the following events: hematological / non-hematological toxicity of Grade 3 or higher.|An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.","Up to Day 28|From signing of Informed Consent Form (ICF) up to follow up (until 100 days after the last dose of study drug or until the start of subsequent anticancer therapy, if earlier)","JNJ-64407564 Serum Concentrations|Biomarker Assessment|Number of Participants with JNJ-64407564 Antibodies","Serum concentrations will be calculated for JNJ-64407564.|Serum cytokine concentrations will be measured pre- and post-infusion of JNJ-64407564 for biomarker assessment.|Antibodies to JNJ-64407564 will be assessed to evaluate potential immunogenicity.","Up to 8 weeks|Up to Cycle 7, Day 1","JNJ.CT@sylogent.com","Study Contact","844-434-4210","Badalona, Spain, 08916 Hosp. Univ. Fund. Jimenez DiazMadrid, Spain, 28040|Duarte, California, United States, 91010|Aurora, Colorado, United States, 80045|New York, New York, United States, 10029|Nashville, Tennessee, United States, 37203","California|Colorado|New York|Tennessee","Spain|United States","Hosp. Univ. Germans Trias I Pujol|City Of Hope|University Of Colorado Cancer Center|Mount Sinai Medical Center|Sarah Cannon Research Institute",{"$nulls":3},"Janssen Research & Development, LLC Clinical Trial","2018-03-29","2020-05-25T16:36:52.894","2020-05-26T17:10:42.972","NCT03399799"]
["5ecbf42511702c1b1b916a6f","NCT03399799","2018-10-12","Johnson & Johnson","JNJ","Recruiting","Dose Escalation Study of JNJ-64407564 in Participants With Relapsed or Refractory Multiple Myeloma","Jnj-64407564","CD3 Inhibitor","Yes","['Jnj-64407564']","Yes","['CD3 Inhibitor']","Phase 1",2,87,"Anticipated","2017-12-16","2020-10-14","DLT","Dose Limiting Toxicity",{"$nulls":3},"The purpose of this study is to characterize the safety of JNJ-64407564 and to determine the recommended Phase 2 dose(s) (RP2Ds) and dosing schedule assessed to be safe for JNJ-64407564 (Part 1 [Dose Escalation]) and to further characterize the safety of JNJ-64407564 at the recommended Phase 2 dose(s) (RP2Ds) (Part 2 [Dose Expansion]).","The study will be conducted in 2 parts: dose escalation and dose expansion. The study will evaluate safety, tolerability, pharmacokinetics and preliminary antitumor activity of JNJ-64407564 administered to adult participants with relapsed or refractory multiple myeloma. The overall safety of the study drug will be assessed by physical examinations, Eastern Cooperative Oncology Group performance status, laboratory tests, vital signs, electrocardiograms, adverse event monitoring, and concomitant medication usage. Disease evaluations will include peripheral blood and bone marrow assessments at screening (performed within 28 days) and to confirm stringent complete response (sCR), complete response (CR), or relapse from CR. The end of study (study completion) is defined as the last study assessment for the last participant in the study.","A Phase 1, First-in-Human, Open-Label, Dose Escalation Study of JNJ-64407564, a Humanized DuoBodyÂ® Antibody, in Subjects With Relapsed or Refractory Multiple Myeloma","CR108404","Hematological Malignancies","Oncology Hematological Unspecified","Oncology Hematological","Oncology","Experimental","Part 1: Dose Escalation (JNJ-64407564)|Part 2: Dose Expansion (JNJ-64407564)","Participants will receive intravenous (IV) infusion of JNJ-64407564 at minimum anticipated biologic effect level (MABEL)-based starting dose until the completion of the end of treatment visit. Subsequent dose levels will be selected based on the review of all available data including, but not limited to, pharmacokinetic, pharmacodynamic, safety, and preliminary antitumor activity data.|Participants will receive IV infusion of JNJ-64407564 at each putative recommended Phase 2 dose(s) (RP2D[s]) as determined in Part 1.","Drug","JNJ-64407564","Participants will receive IV infusion of JNJ-64407564.",null,"Part 1: Dose Escalation (JNJ-64407564)|Part 2: Dose Expansion (JNJ-64407564)","\n\n * Documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria\n * Participants with measurable multiple myeloma who have progressed on, or could not tolerate, all available established therapies\n * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1\n * Women of childbearing potential must have a negative pregnancy test at screening and prior to the first dose of study drug using a highly sensitive pregnancy test either serum (Beta human chorionic gonadotropin [beta-hCG]) or urine\n * Sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study, and is willing to and able participate in the study. Consent is to be obtained prior to the initiation of any study-related tests or procedures that are not part of standard-of-care for the participant's disease\n\n","\n\n * Vaccinated with live, attenuated vaccine within 4 weeks or as recommended by the product manufacturer prior to the first dose, during treatment, or within 100 days of the last dose of JNJ-64407564\n * Toxicities from previous anticancer therapies should have resolved to baseline levels or to Grade 1 or less except for alopecia or peripheral neuropathy\n * Received a cumulative dose of corticosteroids equivalent to greater than or equal to ( >=) 140 milligram (mg) of prednisone within the 14-day period before the first dose of study drug\n * Stem cell transplantation: Previously received an allogenic stem cell transplant; and/or received an autologous stem cell transplant less than or equal to (<=) 12 weeks before the first dose of study drug\n * Documented history of central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma. If either is suspected, whole body magnetic resonance imaging (MRI) and lumbar cytology are required",{"$nulls":4},"Actual","2018-01-16","Actual","Anticipated","2020-10-14","Anticipated","2018-10-01","2017-12-22","2018-01-08","2018-10-11","No",null,"Interventional","Treatment","Sequential Assignment","None (Open Label)","Non-Randomized","18 Years",null,"All",null,"No",null,null,"URL: http://pam.sylogent.com/cr/CR108404 [http://pam.sylogent.com/cr/CR108404] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To learn how to participate in this trial please click here.",null,"Yes","No",{"$nulls":17},"2017-002400-26|64407564MMY1001","EudraCT Number|Janssen Research & Development, LLC","Part 1: Dose-limiting Toxicity (DLT)|Part 1 and Part 2: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability","The Dose Limiting Toxicities (DLTs) are based on drug related adverse events and defined as any of the following events: hematological / non-hematological toxicity of Grade 3 or higher.|An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.","Up to Day 28|From signing of Informed Consent Form (ICF) up to follow up (until 100 days after the last dose of study drug or until the start of subsequent anticancer therapy, if earlier","Part 1: JNJ-64407564 Serum Concentrations|Part 1 and Part 2: Biomarker Assessment|Part 1: Number of Participants with JNJ-64407564 Antibodies|Part 2: Overall Response Rate (ORR)|Part 2: Clinical Benefit Rate (CBR)|Part 2: Duration of Response (DOR)|Part 2: Time to Response (TTR)|Part 2: Progression-Free Survival (PFS)","Serum concentrations will be calculated for JNJ-64407564.|Serum cytokine concentrations will be measured pre- and post-infusion of JNJ-64407564 for biomarker assessment.|Antibodies to JNJ-64407564 will be assessed to evaluate potential immunogenicity.|ORR is defined as the proportion of participants who have a partial response (PR) or better according to the international myeloma working group (IMWG) criteria.|CBR is defined as the proportion of participants who have a minimal response (MR) or better according to the IMWG criteria.|DOR is defined as time from date of initial documentation of a response (PR or better) to date of first documented evidence of PD, per IMWG criteria.|TTR is defined as the time between date of first dose of study drug and the first efficacy evaluation that the participant has met all criteria for PR or better.|PFS is defined as time from date of first dose of study drug to date of first documented PD, per IMWG criteria, or death due to any cause, whichever occurs first.","Up to 8 weeks|Up to Cycle 7 Day 1 (each cycle of 21-days)|Approximately 2.10 years|From the date of initial documentation of a response to the date of first documented evidence of progressive disease (PD) (approximately 2.10 years)|From the date of first dose of study drug to the date of initial documentation of a response (approximately 2.10 years)|From the date of first dose of study drug to the date of first documented progressive disease, or death, whichever occurs first (approximately 18 months)","JNJ.CT@sylogent.com","Study Contact","844-434-4210","Badalona, Spain, 08916 Hosp. Univ. Fund. Jimenez DiazMadrid, Spain, 28040|Duarte, California, United States, 91010|Aurora, Colorado, United States, 80045|New York, New York, United States, 10029|Nashville, Tennessee, United States, 37203","California|Colorado|New York|Tennessee","Spain|United States","Hosp. Univ. Germans Trias I Pujol|City Of Hope|University Of Colorado Cancer Center|Mount Sinai Medical Center|Sarah Cannon Research Institute",{"$nulls":3},"Janssen Research & Development, LLC Clinical Trial","2018-10-11","2020-05-25T16:36:53.101","2020-05-26T17:10:42.972","NCT03399799"]
["5ecbf42511702c1b1b916a70","NCT03399799","2019-02-26","Johnson & Johnson","JNJ","Recruiting","Dose Escalation Study of JNJ-64407564 in Participants With Relapsed or Refractory Multiple Myeloma","Jnj-64407564","CD3 Inhibitor","Yes","['Jnj-64407564']","Yes","['CD3 Inhibitor']","Phase 1",3,87,"Anticipated","2017-12-16","2020-06-15","DLT","Dose Limiting Toxicity",{"$nulls":3},"The purpose of this study is to characterize the safety of JNJ-64407564 and to determine the recommended Phase 2 dose(s) (RP2Ds) and dosing schedule assessed to be safe for JNJ-64407564 (Part 1 [Dose Escalation]) and to further characterize the safety of JNJ-64407564 at the recommended Phase 2 dose(s) (RP2Ds) (Part 2 [Dose Expansion]).","The study will be conducted in 2 parts, separately for intravenous (IV) and subcutaneous (SC) administration: dose escalation and dose expansion. The study will evaluate safety, tolerability, pharmacokinetics and preliminary antitumor activity of JNJ-64407564 administered to adult participants with relapsed or refractory multiple myeloma. The overall safety of the study drug will be assessed by physical examinations, Eastern Cooperative Oncology Group performance status, laboratory tests, vital signs, electrocardiograms, adverse event monitoring, and concomitant medication usage. Disease evaluations will include peripheral blood and bone marrow assessments at screening (performed within 28 days) and to confirm stringent complete response (sCR), complete response (CR), or relapse from CR. The end of study (study completion) is defined as the last study assessment for the last participant in the study.","A Phase 1, First-in-Human, Open-Label, Dose Escalation Study of JNJ-64407564, a Humanized DuoBodyÂ® Antibody, in Subjects With Relapsed or Refractory Multiple Myeloma","CR108404","Hematological Malignancies","Oncology Hematological Unspecified","Oncology Hematological","Oncology","Experimental","Part 1: Dose Escalation (JNJ-64407564) - Intravenous (IV)|Part 1: Dose Escalation (JNJ-64407564) - Subcutaneous (SC)|Part 2: Dose Expansion (JNJ-64407564)","Participants will receive IV infusion of JNJ-64407564 at minimum anticipated biologic effect level (MABEL)-based starting dose until the completion of the end of treatment visit. Subsequent dose levels will be selected based on the review of all available data including, but not limited to, pharmacokinetic, pharmacodynamic, safety, and preliminary antitumor activity data.|Participants will receive JNJ-64407564 SC initially at an IV dose deemed safe and approved by the safety evaluation team (SET). Subsequent SC dose levels will be selected to identify safe and tolerable putative RP2D(s).|Participants will receive IV infusion or SC injection of JNJ-64407564 at each putative recommended Phase 2 dose(s) (RP2D[s]) as determined in Part 1.","Drug","JNJ-64407564","Participants will receive IV infusion or SC injection of JNJ-64407564.",null,"Part 1: Dose Escalation (JNJ-64407564) - Intravenous (IV)|Part 1: Dose Escalation (JNJ-64407564) - Subcutaneous (SC)|Part 2: Dose Expansion (JNJ-64407564)","\n\n * Documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria\n * Participants with measurable multiple myeloma who have progressed on, or could not tolerate, all available established therapies\n * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1\n * Women of childbearing potential must have a negative pregnancy test at screening and prior to the first dose of study drug using a highly sensitive pregnancy test either serum (Beta human chorionic gonadotropin [beta-hCG]) or urine\n * Sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study, and is willing to and able participate in the study. Consent is to be obtained prior to the initiation of any study-related tests or procedures that are not part of standard-of-care for the participant's disease\n\n","\n\n * Vaccinated with live, attenuated vaccine within 4 weeks or as recommended by the product manufacturer prior to the first dose, during treatment, or within 100 days of the last dose of JNJ-64407564\n * Toxicities from previous anticancer therapies should have resolved to baseline levels or to Grade 1 or less except for alopecia or peripheral neuropathy\n * Received a cumulative dose of corticosteroids equivalent to greater than or equal to ( >=) 140 milligram (mg) of prednisone within the 14-day period before the first dose of study drug\n * An allogenic stem cell transplant within 6 months before first dose of study drug. Participants who received an allogeneic transplant must be off all immunosuppressive medications for 6 weeks without signs of graft-versus-host disease (GVHD); and/or an autologous stem cell transplant less than or equal to (<=) 12 weeks before first dose of study drug\n * Documented history of central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma. If either is suspected, whole body magnetic resonance imaging (MRI) and lumbar cytology are required",{"$nulls":4},"Actual","2018-01-16","Actual","Anticipated","2020-06-16","Anticipated","2019-02-01","2017-12-22","2018-01-08","2019-02-22","No",null,"Interventional","Treatment","Sequential Assignment","None (Open Label)","Non-Randomized","18 Years",null,"All",null,"No",null,null,"URL: http://pam.sylogent.com/cr/CR108404 [http://pam.sylogent.com/cr/CR108404] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To learn how to participate in this trial please click here.",null,"Yes","No",{"$nulls":17},"2017-002400-26|64407564MMY1001","EudraCT Number|Janssen Research & Development, LLC","Part 1: Dose-limiting Toxicity (DLT)|Part 1 and Part 2: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability","The Dose Limiting Toxicities (DLTs) are based on drug related adverse events and defined as any of the following events: hematological / non-hematological toxicity of Grade 3 or higher.|An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.","Up to Day 28|From signing of Informed Consent Form (ICF) up to follow up (until 100 days after the last dose of study drug or until the start of subsequent anticancer therapy, if earlier","Part 1: JNJ-64407564 Serum Concentrations|Part 1 and Part 2: Biomarker Assessment|Part 1: Number of Participants with JNJ-64407564 Antibodies|Part 2: Overall Response Rate (ORR)|Part 2: Clinical Benefit Rate (CBR)|Part 2: Duration of Response (DOR)|Part 2: Time to Response (TTR)|Part 2: Progression-Free Survival (PFS)","Serum concentrations will be calculated for JNJ-64407564.|Serum cytokine concentrations will be measured pre- and post-infusion of JNJ-64407564 for biomarker assessment.|Antibodies to JNJ-64407564 will be assessed to evaluate potential immunogenicity.|ORR is defined as the proportion of participants who have a partial response (PR) or better according to the international myeloma working group (IMWG) criteria.|CBR is defined as the proportion of participants who have a minimal response (MR) or better according to the IMWG criteria.|DOR is defined as time from date of initial documentation of a response (PR or better) to date of first documented evidence of PD, per IMWG criteria.|TTR is defined as the time between date of first dose of study drug and the first efficacy evaluation that the participant has met all criteria for PR or better.|PFS is defined as time from date of first dose of study drug to date of first documented PD, per IMWG criteria, or death due to any cause, whichever occurs first.","Up to 8 weeks|Up to Cycle 7 Day 1 (each cycle of 21-days)|Approximately 2.10 years|From the date of initial documentation of a response to the date of first documented evidence of progressive disease (PD) (approximately 2.10 years)|From the date of first dose of study drug to the date of initial documentation of a response (approximately 2.10 years)|From the date of first dose of study drug to the date of first documented progressive disease, or death, whichever occurs first (approximately 18 months)","JNJ.CT@sylogent.com","Study Contact","844-434-4210","Amsterdam, Netherlands, 1081 Hv UmcuUtrecht, Netherlands, 3584 Cx|Badalona, Spain, 08916 Hosp. Univ. Fund. Jimenez DiazMadrid, Spain, 28040 Clinica Univ. De NavarraPamplona, Spain, 31008 Hosp. Clinico Univ. De SalamancaSalamanca, Spain, 37007|Duarte, California, United States, 91010|Aurora, Colorado, United States, 80045|New York, New York, United States, 10029|Nashville, Tennessee, United States, 37203","California|Colorado|New York|Tennessee","Netherlands|Spain|United States","Vu Medisch Centrum|Hosp. Univ. Germans Trias I Pujol|City Of Hope|University Of Colorado Cancer Center|Mount Sinai Medical Center|Sarah Cannon Research Institute",{"$nulls":3},"Janssen Research & Development, LLC Clinical Trial","2019-02-22","2020-05-25T16:36:53.600","2020-05-26T17:10:42.972","NCT03399799"]
["5ecbf425feab101b15530890","NCT03399799","2019-05-24","Johnson & Johnson","JNJ","Recruiting","Dose Escalation Study of JNJ-64407564 in Participants With Relapsed or Refractory Multiple Myeloma","Jnj-64407564","CD3 Inhibitor","Yes","['Jnj-64407564']","Yes","['CD3 Inhibitor']","Phase 1",3,87,"Anticipated","2017-12-16","2020-06-15","DLT","Dose Limiting Toxicity",{"$nulls":3},"The purpose of this study is to characterize the safety of JNJ-64407564 and to determine the recommended Phase 2 dose(s) (RP2Ds) and dosing schedule assessed to be safe for JNJ-64407564 (Part 1 [Dose Escalation]) and to further characterize the safety of JNJ-64407564 at the recommended Phase 2 dose(s) (RP2Ds) (Part 2 [Dose Expansion]).","The study will be conducted in 2 parts, separately for intravenous (IV) and subcutaneous (SC) administration: dose escalation and dose expansion. The study will evaluate safety, tolerability, pharmacokinetics and preliminary antitumor activity of JNJ-64407564 administered to adult participants with relapsed or refractory multiple myeloma. The overall safety of the study drug will be assessed by physical examinations, Eastern Cooperative Oncology Group performance status, laboratory tests, vital signs, electrocardiograms, adverse event monitoring, and concomitant medication usage. Disease evaluations will include peripheral blood and bone marrow assessments at screening (performed within 28 days) and to confirm stringent complete response (sCR), complete response (CR), or relapse from CR. The end of study (study completion) is defined as the last study assessment for the last participant in the study.","A Phase 1, First-in-Human, Open-Label, Dose Escalation Study of JNJ-64407564, a Humanized DuoBodyÂ® Antibody, in Subjects With Relapsed or Refractory Multiple Myeloma","CR108404","Hematological Malignancies","Oncology Hematological Unspecified","Oncology Hematological","Oncology","Experimental","Part 1: Dose Escalation (JNJ-64407564) - Intravenous (IV)|Part 1: Dose Escalation (JNJ-64407564) - Subcutaneous (SC)|Part 2: Dose Expansion (JNJ-64407564)","Participants will receive IV infusion of JNJ-64407564 at minimum anticipated biologic effect level (MABEL)-based starting dose until the completion of the end of treatment visit. Subsequent dose levels will be selected based on the review of all available data including, but not limited to, pharmacokinetic, pharmacodynamic, safety, and preliminary antitumor activity data.|Participants will receive JNJ-64407564 SC. The dose levels will be selected to identify safe and tolerable putative RP2D(s).|Participants will receive IV infusion or SC injection of JNJ-64407564 at each putative recommended Phase 2 dose(s) (RP2D[s]) as determined in Part 1.","Drug","JNJ-64407564","Participants will receive IV infusion or SC injection of JNJ-64407564.",null,"Part 1: Dose Escalation (JNJ-64407564) - Intravenous (IV)|Part 1: Dose Escalation (JNJ-64407564) - Subcutaneous (SC)|Part 2: Dose Expansion (JNJ-64407564)","\n\n * Documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria\n * Participants with measurable multiple myeloma who have progressed on, or could not tolerate, all available established therapies\n * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1\n * Women of childbearing potential must have a negative pregnancy test at screening and prior to the first dose of study drug using a highly sensitive pregnancy test either serum (Beta human chorionic gonadotropin [beta-hCG]) or urine\n * Sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study, and is willing to and able participate in the study. Consent is to be obtained prior to the initiation of any study-related tests or procedures that are not part of standard-of-care for the participant's disease\n\n","\n\n * Vaccinated with live, attenuated vaccine within 4 weeks or as recommended by the product manufacturer prior to the first dose, during treatment, or within 100 days of the last dose of JNJ-64407564\n * Toxicities from previous anticancer therapies should have resolved to baseline levels or to Grade 1 or less except for alopecia or peripheral neuropathy\n * Received a cumulative dose of corticosteroids equivalent to greater than or equal to ( >=) 140 milligram (mg) of prednisone within the 14-day period before the first dose of study drug\n * An allogenic stem cell transplant within 6 months before first dose of study drug. Participants who received an allogeneic transplant must be off all immunosuppressive medications for 6 weeks without signs of graft-versus-host disease (GVHD); and/or an autologous stem cell transplant less than or equal to (<=) 12 weeks before first dose of study drug\n * Documented history of central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma. If either is suspected, whole body magnetic resonance imaging (MRI) and lumbar cytology are required",{"$nulls":4},"Actual","2018-01-16","Actual","Anticipated","2020-06-16","Anticipated","2019-05-01","2017-12-22","2018-01-08","2019-05-23","No",null,"Interventional","Treatment","Sequential Assignment","None (Open Label)","Non-Randomized","18 Years",null,"All",null,"No",null,null,"URL: http://pam.sylogent.com/cr/CR108404 [http://pam.sylogent.com/cr/CR108404] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To learn how to participate in this trial please click here.",null,"Yes","No",{"$nulls":17},"2017-002400-26|64407564MMY1001","EudraCT Number|Janssen Research & Development, LLC","Part 1: Dose-limiting Toxicity (DLT)|Part 1 and Part 2: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability","The Dose Limiting Toxicities (DLTs) are based on drug related adverse events and defined as any of the following events: hematological / non-hematological toxicity of Grade 3 or higher.|An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.","Up to Day 28|From signing of Informed Consent Form (ICF) up to follow up (until 100 days after the last dose of study drug or until the start of subsequent anticancer therapy, if earlier","Part 1: JNJ-64407564 Serum Concentrations|Part 1 and Part 2: Biomarker Assessment|Part 1: Number of Participants with JNJ-64407564 Antibodies|Part 2: Overall Response Rate (ORR)|Part 2: Clinical Benefit Rate (CBR)|Part 2: Duration of Response (DOR)|Part 2: Time to Response (TTR)|Part 2: Progression-Free Survival (PFS)","Serum concentrations will be calculated for JNJ-64407564.|Serum cytokine concentrations will be measured pre- and post-infusion of JNJ-64407564 for biomarker assessment.|Antibodies to JNJ-64407564 will be assessed to evaluate potential immunogenicity.|ORR is defined as the proportion of participants who have a partial response (PR) or better according to the international myeloma working group (IMWG) criteria.|CBR is defined as the proportion of participants who have a minimal response (MR) or better according to the IMWG criteria.|DOR is defined as time from date of initial documentation of a response (PR or better) to date of first documented evidence of PD, per IMWG criteria.|TTR is defined as the time between date of first dose of study drug and the first efficacy evaluation that the participant has met all criteria for PR or better.|PFS is defined as time from date of first dose of study drug to date of first documented PD, per IMWG criteria, or death due to any cause, whichever occurs first.","Up to 8 weeks|Up to Cycle 7 Day 1 (each cycle of 21-days)|Approximately 2.10 years|From the date of initial documentation of a response to the date of first documented evidence of progressive disease (PD) (approximately 2.10 years)|From the date of first dose of study drug to the date of initial documentation of a response (approximately 2.10 years)|From the date of first dose of study drug to the date of first documented progressive disease, or death, whichever occurs first (approximately 18 months)","JNJ.CT@sylogent.com","Study Contact","844-434-4210","Amsterdam, Netherlands, 1081 Hv UmcuUtrecht, Netherlands, 3584 Cx|Badalona, Spain, 08916 Hosp. Univ. Fund. Jimenez DiazMadrid, Spain, 28040 Clinica Univ. De NavarraPamplona, Spain, 31008 Hosp. Clinico Univ. De SalamancaSalamanca, Spain, 37007|Duarte, California, United States, 91010|Aurora, Colorado, United States, 80045|New York, New York, United States, 10029|Nashville, Tennessee, United States, 37203","California|Colorado|New York|Tennessee","Netherlands|Spain|United States","Vu Medisch Centrum|Hosp. Univ. Germans Trias I Pujol|City Of Hope|University Of Colorado Cancer Center|Mount Sinai Medical Center|Sarah Cannon Research Institute",{"$nulls":3},"Janssen Research & Development, LLC Clinical Trial","2019-05-23","2020-05-25T16:36:53.394","2020-05-26T17:10:42.972","NCT03399799"]
["5ecbf425e2561b1b11905d5c","NCT03399799","2019-09-09","Johnson & Johnson","JNJ","Recruiting","Dose Escalation Study of JNJ-64407564 in Participants With Relapsed or Refractory Multiple Myeloma","Jnj-64407564","CD3 Inhibitor","Yes","['Jnj-64407564']","Yes","['CD3 Inhibitor']","Phase 1",3,185,"Anticipated","2017-12-16","2020-06-15","DLT","Dose Limiting Toxicity",{"$nulls":3},"The purpose of this study is to characterize the safety of JNJ-64407564 and to determine the recommended Phase 2 dose(s) (RP2Ds) and dosing schedule assessed to be safe for JNJ-64407564 (Part 1 [Dose Escalation]) and to further characterize the safety of JNJ-64407564 at the recommended Phase 2 dose(s) (RP2Ds) (Part 2 [Dose Expansion]).","The study will be conducted in 2 parts, separately for intravenous (IV) and subcutaneous (SC) administration: dose escalation and dose expansion. The study will evaluate safety, tolerability, pharmacokinetics and preliminary antitumor activity of JNJ-64407564 administered to adult participants with relapsed or refractory multiple myeloma. The overall safety of the study drug will be assessed by physical examinations, Eastern Cooperative Oncology Group performance status, laboratory tests, vital signs, electrocardiograms, adverse event monitoring, and concomitant medication usage. Disease evaluations will include peripheral blood and bone marrow assessments at screening (performed within 28 days) and to confirm stringent complete response (sCR), complete response (CR), or relapse from CR. The end of study (study completion) is defined as the last study assessment for the last participant in the study.","A Phase 1, First-in-Human, Open-Label, Dose Escalation Study of JNJ-64407564, a Humanized DuoBodyÂ® Antibody, in Subjects With Relapsed or Refractory Multiple Myeloma","CR108404","Hematological Malignancies","Oncology Hematological Unspecified","Oncology Hematological","Oncology","Experimental","Part 1: Dose Escalation (JNJ-64407564) - Intravenous (IV)|Part 1: Dose Escalation (JNJ-64407564) - Subcutaneous (SC)|Part 2: Dose Expansion (JNJ-64407564)","Participants will receive IV infusion of JNJ-64407564 at minimum anticipated biologic effect level (MABEL)-based starting dose until the completion of the end of treatment visit. Subsequent dose levels will be selected based on the review of all available data including, but not limited to, pharmacokinetic, pharmacodynamic, safety, and preliminary antitumor activity data.|Participants will receive JNJ-64407564 SC. The dose levels will be selected to identify safe and tolerable putative RP2D(s).|Participants will receive IV infusion or SC injection of JNJ-64407564 at each putative recommended Phase 2 dose(s) (RP2D[s]) as determined in Part 1.","Drug","JNJ-64407564","Participants will receive IV infusion or SC injection of JNJ-64407564.",null,"Part 1: Dose Escalation (JNJ-64407564) - Intravenous (IV)|Part 1: Dose Escalation (JNJ-64407564) - Subcutaneous (SC)|Part 2: Dose Expansion (JNJ-64407564)","\n\n * Documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria\n * Participants with measurable multiple myeloma who have progressed on, or could not tolerate, all available established therapies\n * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1\n * Women of childbearing potential must have a negative pregnancy test at screening and prior to the first dose of study drug using a highly sensitive pregnancy test either serum (Beta human chorionic gonadotropin [beta-hCG]) or urine\n * Sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study, and is willing to and able participate in the study. Consent is to be obtained prior to the initiation of any study-related tests or procedures that are not part of standard-of-care for the participant's disease\n\n","\n\n * Vaccinated with live, attenuated vaccine within 4 weeks or as recommended by the product manufacturer prior to the first dose, during treatment, or within 100 days of the last dose of JNJ-64407564\n * Toxicities from previous anticancer therapies should have resolved to baseline levels or to Grade 1 or less except for alopecia or peripheral neuropathy\n * Received a cumulative dose of corticosteroids equivalent to greater than or equal to ( >=) 140 milligram (mg) of prednisone within the 14-day period before the first dose of study drug\n * An allogenic stem cell transplant within 6 months before first dose of study drug. Participants who received an allogeneic transplant must be off all immunosuppressive medications for 6 weeks without signs of graft-versus-host disease (GVHD); and/or an autologous stem cell transplant less than or equal to (<=) 12 weeks before first dose of study drug\n * Documented history of central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma. If either is suspected, whole body magnetic resonance imaging (MRI) and lumbar cytology are required",{"$nulls":4},"Actual","2018-01-16","Actual","Anticipated","2021-01-18","Anticipated","2019-09-01","2017-12-22","2018-01-08","2019-09-06","No",null,"Interventional","Treatment","Sequential Assignment","None (Open Label)","Non-Randomized","18 Years",null,"All",null,"No",null,null,"URL: http://pam.sylogent.com/cr/CR108404 [http://pam.sylogent.com/cr/CR108404] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To learn how to participate in this trial please click here.",null,"Yes","No",{"$nulls":17},"2017-002400-26|64407564MMY1001","EudraCT Number|Janssen Research & Development, LLC","Part 1: Dose-limiting Toxicity (DLT)|Part 1 and Part 2: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability","The Dose Limiting Toxicities (DLTs) are based on drug related adverse events and defined as any of the following events: hematological / non-hematological toxicity of Grade 3 or higher.|An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.","Up to Day 28|From signing of Informed Consent Form (ICF) up to follow up (until 100 days after the last dose of study drug or until the start of subsequent anticancer therapy, if earlier","Part 1: JNJ-64407564 Serum Concentrations|Part 1 and Part 2: Biomarker Assessment|Part 1: Number of Participants with JNJ-64407564 Antibodies|Part 2: Overall Response Rate (ORR)|Part 2: Clinical Benefit Rate (CBR)|Part 2: Duration of Response (DOR)|Part 2: Time to Response (TTR)|Part 2: Progression-Free Survival (PFS)","Serum concentrations will be calculated for JNJ-64407564.|Serum cytokine concentrations will be measured pre- and post-infusion of JNJ-64407564 for biomarker assessment.|Antibodies to JNJ-64407564 will be assessed to evaluate potential immunogenicity.|ORR is defined as the proportion of participants who have a partial response (PR) or better according to the international myeloma working group (IMWG) criteria.|CBR is defined as the proportion of participants who have a minimal response (MR) or better according to the IMWG criteria.|DOR is defined as time from date of initial documentation of a response (PR or better) to date of first documented evidence of PD, per IMWG criteria.|TTR is defined as the time between date of first dose of study drug and the first efficacy evaluation that the participant has met all criteria for PR or better.|PFS is defined as time from date of first dose of study drug to date of first documented PD, per IMWG criteria, or death due to any cause, whichever occurs first.","Up to 8 weeks|Up to Cycle 7 Day 1 (each cycle of 21-days)|Approximately 2.10 years|From the date of initial documentation of a response to the date of first documented evidence of progressive disease (PD) (approximately 2.10 years)|From the date of first dose of study drug to the date of initial documentation of a response (approximately 2.10 years)|From the date of first dose of study drug to the date of first documented progressive disease, or death, whichever occurs first (approximately 18 months)","JNJ.CT@sylogent.com","Study Contact","844-434-4210","Amsterdam, Netherlands, 1081 Hv UmcuUtrecht, Netherlands, 3584 Cx|Badalona, Spain, 08916 Hosp. Univ. Fund. Jimenez DiazMadrid, Spain, 28040 Clinica Univ. De NavarraPamplona, Spain, 31008 Hosp. Clinico Univ. De SalamancaSalamanca, Spain, 37007|Duarte, California, United States, 91010|Aurora, Colorado, United States, 80045|New York, New York, United States, 10029|Nashville, Tennessee, United States, 37203","California|Colorado|New York|Tennessee","Netherlands|Spain|United States","Vu Medisch Centrum|Hosp. Univ. Germans Trias I Pujol|City Of Hope|University Of Colorado Cancer Center|Mount Sinai Medical Center|Sarah Cannon Research Institute",{"$nulls":3},"Janssen Research & Development, LLC Clinical Trial","2019-09-06","2020-05-25T16:36:53.996","2020-05-26T17:10:42.972","NCT03399799"]
["5ecbf426feab101b15530893","NCT03399799","2019-11-08","Johnson & Johnson","JNJ","Recruiting","Dose Escalation Study of JNJ-64407564 in Participants With Relapsed or Refractory Multiple Myeloma","Jnj-64407564","CD3 Inhibitor","Yes","['Jnj-64407564']","Yes","['CD3 Inhibitor']","Phase 1",3,185,"Anticipated","2017-12-16","2020-06-15","DLT","Dose Limiting Toxicity",{"$nulls":3},"The purpose of this study is to characterize the safety of JNJ-64407564 and to determine the recommended Phase 2 dose(s) (RP2Ds) and dosing schedule assessed to be safe for JNJ-64407564 (Part 1 [Dose Escalation]) and to further characterize the safety of JNJ-64407564 at the recommended Phase 2 dose(s) (RP2Ds) (Part 2 [Dose Expansion]).","The study will be conducted in 2 parts, separately for intravenous (IV) and subcutaneous (SC) administration: dose escalation and dose expansion. The study will evaluate safety, tolerability, pharmacokinetics and preliminary antitumor activity of JNJ-64407564 administered to adult participants with relapsed or refractory multiple myeloma. The overall safety of the study drug will be assessed by physical examinations, Eastern Cooperative Oncology Group performance status, laboratory tests, vital signs, electrocardiograms, adverse event monitoring, and concomitant medication usage. Disease evaluations will include peripheral blood and bone marrow assessments at screening (performed within 28 days) and to confirm stringent complete response (sCR), complete response (CR), or relapse from CR. The end of study (study completion) is defined as the last study assessment for the last participant in the study.","A Phase 1, First-in-Human, Open-Label, Dose Escalation Study of JNJ-64407564, a Humanized DuoBodyÂ® Antibody, in Subjects With Relapsed or Refractory Multiple Myeloma","CR108404","Hematological Malignancies","Oncology Hematological Unspecified","Oncology Hematological","Oncology","Experimental","Part 1: Dose Escalation (JNJ-64407564) - Intravenous (IV)|Part 1: Dose Escalation (JNJ-64407564) - Subcutaneous (SC)|Part 2: Dose Expansion (JNJ-64407564)","Participants will receive IV infusion of JNJ-64407564 at minimum anticipated biologic effect level (MABEL)-based starting dose until the completion of the end of treatment visit. Subsequent dose levels will be selected based on the review of all available data including, but not limited to, pharmacokinetic, pharmacodynamic, safety, and preliminary antitumor activity data.|Participants will receive JNJ-64407564 SC. The dose levels will be selected to identify safe and tolerable putative RP2D(s).|Participants will receive IV infusion or SC injection of JNJ-64407564 at each putative recommended Phase 2 dose(s) (RP2D[s]) as determined in Part 1.","Drug","JNJ-64407564","Participants will receive IV infusion or SC injection of JNJ-64407564.",null,"Part 1: Dose Escalation (JNJ-64407564) - Intravenous (IV)|Part 1: Dose Escalation (JNJ-64407564) - Subcutaneous (SC)|Part 2: Dose Expansion (JNJ-64407564)","\n\n * Documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria\n * Participants with measurable multiple myeloma who have progressed on, or could not tolerate, all available established therapies\n * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1\n * Women of childbearing potential must have a negative pregnancy test at screening and prior to the first dose of study drug using a highly sensitive pregnancy test either serum (Beta human chorionic gonadotropin [beta-hCG]) or urine\n * Sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study, and is willing to and able participate in the study. Consent is to be obtained prior to the initiation of any study-related tests or procedures that are not part of standard-of-care for the participant's disease\n\n","\n\n * Vaccinated with live, attenuated vaccine within 4 weeks or as recommended by the product manufacturer prior to the first dose, during treatment, or within 100 days of the last dose of JNJ-64407564\n * Toxicities from previous anticancer therapies should have resolved to baseline levels or to Grade 1 or less except for alopecia or peripheral neuropathy\n * Received a cumulative dose of corticosteroids equivalent to greater than or equal to ( >=) 140 milligram (mg) of prednisone within the 14-day period before the first dose of study drug\n * An allogenic stem cell transplant within 6 months before first dose of study drug. Participants who received an allogeneic transplant must be off all immunosuppressive medications for 6 weeks without signs of graft-versus-host disease (GVHD); and/or an autologous stem cell transplant less than or equal to (<=) 12 weeks before first dose of study drug\n * Documented history of central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma. If either is suspected, whole body magnetic resonance imaging (MRI) and lumbar cytology are required",{"$nulls":4},"Actual","2018-01-16","Actual","Anticipated","2021-05-17","Anticipated","2019-11-01","2017-12-22","2018-01-08","2019-11-07","No",null,"Interventional","Treatment","Sequential Assignment","None (Open Label)","Non-Randomized","18 Years",null,"All",null,"No",null,null,"URL: http://pam.sylogent.com/cr/CR108404 [http://pam.sylogent.com/cr/CR108404] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To learn how to participate in this trial please click here.",null,"Yes","No",{"$nulls":17},"2017-002400-26|64407564MMY1001","EudraCT Number|Janssen Research & Development, LLC","Part 1: Dose-limiting Toxicity (DLT)|Part 1 and Part 2: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability","The Dose Limiting Toxicities (DLTs) are based on drug related adverse events and defined as any of the following events: hematological / non-hematological toxicity of Grade 3 or higher.|An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.","Up to Day 28|From signing of Informed Consent Form (ICF) up to follow up (until 100 days after the last dose of study drug or until the start of subsequent anticancer therapy, if earlier","Part 1: JNJ-64407564 Serum Concentrations|Part 1 and Part 2: Biomarker Assessment|Part 1: Number of Participants with JNJ-64407564 Antibodies|Part 2: Overall Response Rate (ORR)|Part 2: Clinical Benefit Rate (CBR)|Part 2: Duration of Response (DOR)|Part 2: Time to Response (TTR)|Part 2: Progression-Free Survival (PFS)","Serum concentrations will be calculated for JNJ-64407564.|Serum cytokine concentrations will be measured pre- and post-infusion of JNJ-64407564 for biomarker assessment.|Antibodies to JNJ-64407564 will be assessed to evaluate potential immunogenicity.|ORR is defined as the proportion of participants who have a partial response (PR) or better according to the international myeloma working group (IMWG) criteria.|CBR is defined as the proportion of participants who have a minimal response (MR) or better according to the IMWG criteria.|DOR is defined as time from date of initial documentation of a response (PR or better) to date of first documented evidence of PD, per IMWG criteria.|TTR is defined as the time between date of first dose of study drug and the first efficacy evaluation that the participant has met all criteria for PR or better.|PFS is defined as time from date of first dose of study drug to date of first documented PD, per IMWG criteria, or death due to any cause, whichever occurs first.","Up to 8 weeks|Up to Cycle 7 Day 1 (each cycle of 21-days)|Approximately 2.10 years|From the date of initial documentation of a response to the date of first documented evidence of progressive disease (PD) (approximately 2.10 years)|From the date of first dose of study drug to the date of initial documentation of a response (approximately 2.10 years)|From the date of first dose of study drug to the date of first documented progressive disease, or death, whichever occurs first (approximately 18 months)","JNJ.CT@sylogent.com","Study Contact","844-434-4210","Amsterdam, Netherlands, 1081 Hv UmcuUtrecht, Netherlands, 3584 Cx|Badalona, Spain, 08916 Hosp. Univ. Fund. Jimenez DiazMadrid, Spain, 28040 Clinica Univ. De NavarraPamplona, Spain, 31008 Hosp. Clinico Univ. De SalamancaSalamanca, Spain, 37007|Duarte, California, United States, 91010|Aurora, Colorado, United States, 80045|New York, New York, United States, 10029|Nashville, Tennessee, United States, 37203","California|Colorado|New York|Tennessee","Netherlands|Spain|United States","Vu Medisch Centrum|Hosp. Univ. Germans Trias I Pujol|City Of Hope|University Of Colorado Cancer Center|Mount Sinai Medical Center|Sarah Cannon Research Institute",{"$nulls":3},"Janssen Research & Development, LLC Clinical Trial","2019-11-07","2020-05-25T16:36:54.917","2020-05-26T17:10:42.972","NCT03399799"]
["5ecbf427fe30261b1a048264","NCT03400033","2018-03-02","GlaxoSmithKline","GSK","Not yet recruiting","Anemia Studies in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat-Three-times Weekly Dosing in Dialysis (ASCEND-TD)","Daprodustat|Epoetin alfa","HIF Inhibitor|ESA Activator","Yes","['Daprodustat', 'Epoetin alfa']","Yes","['HIF Inhibitor']","Phase 3",2,402,"Anticipated","2018-09-10","2020-07-07",{"$nulls":5},"This Phase 3 study in hemodialysis-dependent subjects with anemia will evaluate the efficacy and safety of daprodustat administered three-times weekly compared to epoetin alfa, the current standard of care. This study includes a 4 week Screening Period, a 52 week Treatment Period and a 4 to 6 week follow-up period. Each subject will remain in the study for up to 62 weeks. Approximately 402 subjects will be randomized to receive either daprodustat three times weekly or epoetin alfa three-times weekly or once weekly, depending on dose level.",null,"A Phase 3 Randomized, Double-blind, Active-controlled, Parallel-group, Multi-center Study in Hemodialysis Participants With Anemia of Chronic Kidney Disease to Evaluate the Efficacy, Safety and Pharmacokinetics of Three-times Weekly Dosing of Daprodustat Compared to Recombinant Human Erythropoietin, Following a Switch From Recombinant Human Erythropoietin or Its Analogs",204837,"Anaemia","Anemia","Hematologic Diseases","Heme & Lymph Diseases","Experimental|Active Comparator","Daprodustat|Epoetin alfa","Subjects randomized to this arm will receive daprodustat tablets titrated doses from 2 to 48 milligrams orally three-times weekly along with saline by IV route for the 52 weeks treatment period.|Subjects randomized to this arm will receive matching placebo tablets to daprodustat orally three-times weekly and Epoetin alfa by IV route for the 52 weeks treatment period.","Drug","Daprodustat tablets|Saline vials or bags|Matching placebo tablets|Epoetin alfa vials","Round, biconvex, white, film-coated tablet in unit dose strengths 2 and 4 milligrams (7 millimeter tablets), 6, 8 and 10 milligrams (9 millimeter tablets) administered by the oral route.|0.9% sodium chloride saline vials or bags administered by the IV route.|Matching placebo to daprodustat tablets supplied as round, biconvex, white, film-coated tablet in unit dose strengths 2 and 4 milligrams (7 millimeter tablets), 6, 8 and 10 milligrams (9 millimeter tablets) administered by the oral route.|Single-dose, preservative-free vials in unit dose strengths of 2000, 3000, 4000 and 10,000 Units/milliliter administered by the IV route.",null,"Daprodustat|Epoetin alfa","\n\n * Subject must be 18 to 99 years of age inclusive, at the time of signing the informed consent.\n * Use of any approved rhEPO or analog for at least 8 weeks prior to the screening visit and continuing during the screening period until randomization (Day 1).\n * Hgb concentration (measured by HemoCue) within the following range: Week -4: Hgb 8 to 11.5 grams/deciliter (5 to 7.1 millimoles/liter). If Hgb is 11.6 to 11.9 grams/deciliter (7.2 to 7.4 millimoles/liter), up to two retests are allowed; the retest value must be between 8 to 11.5 grams/deciliter (5 to 7.1 millimoles/liter). Day 1: Hgb 8 to 11 grams/deciliter (5 to 6.8 millimoles/liter) and receiving at least the minimum rhEPO or analog dose 3. Hgb>11 to 11.5 grams/deciliter (6.8 to 7.1 millimoles/liter) and receiving greater than the minimum rhEPO or analog dose 3.\n * On hemodialysis (including hemofiltration or hemodiafiltration) >90 days prior to screening and continuing during the screening period.\n * On hemodialysis (in-center) >=3 times per week.\n * Male and female subjects are eligible. A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: Not a woman of childbearing potential (WOCBP), or A WOCBP who agrees to follow the contraceptive guidance from at least 28 days prior to first dose of study treatment and for at least 28 days after the last dose of study treatment.\n * Capable of giving signed informed consent.\n * In France, a subject will be eligible for inclusion in this study if he or she is either affiliated to or beneficiary of a social security category.\n\n","\n\n * Planned living-related or living-unrelated kidney transplant within 52 weeks after randomization (Day 1).\n * Ferritin: <=100 nanograms/milliliter (<=100 micrograms/liter), at screening.\n * Transferrin saturation (TSAT): <=20 percent, at screening. If TSAT is 18 to 20 percent, then a retest using a new blood sample can be obtained within 7 days of the final laboratory report; the final retest value must be >20 percent to confirm eligibility.\n * Aplasias: History of bone marrow aplasia or pure red cell aplasia.\n * Conditions, other than anemia of CKD, which can affect erythropoiesis.\n * Myocardial infarction (MI) or acute coronary syndrome within 8 weeks prior to screening through to randomization (Day 1).\n * Stroke or transient ischemic attack within 8 weeks prior to screening through to randomization (Day 1).\n * Heart failure (HF): Chronic Class IV HF, as defined by the New York Heart Association (NYHA) functional classification system.\n * Current uncontrolled hypertension as determined by the investigator that would contraindicate the use of rhEPO.\n * Bazett's correction of QTc interval (QTcB): at Day 1: QTcB >500 milliseconds, or QTcB >530 milliseconds in subjects with bundle branch block. There is no QTc (corrected QT) exclusion for subjects with a predominantly ventricular paced rhythm.\n * Liver Disease: presence of any one of the following liver-related laboratory values or conditions, at screening, is exclusionary: ALT >2x upper limit of normal (ULN); Bilirubin >1.5x ULN; or Current unstable liver or biliary disease per investigator assessment, generally defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis.\n * Evidence of actively bleeding gastric, duodenal or esophageal ulcer disease OR clinically significant gastro intestinal bleeding <= 8 weeks prior to screening through to randomization (Day 1).\n * History of malignancy within 2 years prior to screening through to randomization (Day 1), currently receiving treatment for cancer, or complex kidney cyst (e.g., Bosniak Category IIF, III or IV) >3 centimeters.\n * Use of a strong inhibitor of Cytochrome P4502C8 [CYP2C8] (e.g. gemfibrozil) or a strong inducer of CYP2C8 (e.g. rifampin/rifampicin).\n * History of severe allergic or anaphylactic reactions or hypersensitivity to excipients in the investigational product (daprodustat) or epoetin alfa.\n * Use of another investigational agent within 30 days or within five half-lives of the investigational agent (whichever is longer) or currently participating in a study of an investigational device prior to screening through to randomization (Day 1).\n * Any prior treatment with daprodustat for treatment duration of >30 days.\n * Any other condition, clinical or laboratory abnormality, or examination finding that the investigator considers would put the subject at unacceptable risk, which may affect study compliance (e.g. intolerance to rhEPO) or prevent understanding of the aims or investigational procedures or possible consequences of the study.",{"$nulls":4},"Actual","2018-01-17","Actual","Anticipated","2020-07-07","Anticipated","2018-03-01","2018-01-08","2018-01-08","2018-03-01","Yes","CKD, EPO, rhEPO, Hemodialysis dependent, Daprodustat","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years","99 Years","All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":19},"Mean change in Hemoglobin (Hgb) between Baseline and over Evaluation period [EP] (Weeks 28 to 52)","Blood samples will be collected from subjects for Hgb measurements.","Baseline and up to Week 52","Mean monthly intravenous (IV) iron dose per subject up to Week 52|Number of subjects with adverse events (AEs), serious adverse events (SAEs), adverse event of special interest (AESI) and MACE|Percentage of time Hgb will be in the analysis range (10 to 11.5 grams/deciliter) over EP (Weeks 28 to 52)|Time to stopping study treatment due to meeting rescue criteria|Number of responders in the Hgb analysis range over EP (Weeks 28 to 52)|Change from Baseline in SBP, DBP and mean arterial pressure (MAP) at Week 52 and at the end of study treatment|Number of BP exacerbation events per 100 subject years|Number of subjects with at least one BP exacerbation event during the study|Pre-dose trough concentration (Ctau) of daprodustat|Pre-dose Ctau of metabolites M2|Pre-dose Ctau of metabolites M4|Pre-dose Ctau of metabolites M3|Pre-dose Ctau of metabolites M5|Pre-dose Ctau of metabolites M6|Pre-dose Ctau of metabolites M13|Maximum observed concentration (Cmax) of daprodustat|Cmax of metabolites M2|Cmax of metabolites M3|Cmax of metabolites M4|Cmax of metabolites M5|Cmax of metabolites M6|Cmax of metabolites M13|Change from Baseline in Patient Global Impression of Severity (PGI-S) score|Absolute values over time for composite of hematology parameters as a measure of safety|Changes from baseline over time in composite of hematology parameters as a measure of safety|Absolute values over time for composite of chemistry parameters as a measure of safety|Changes from baseline over time in composite of chemistry parameters as a measure of safety|Absolute values of systolic and diastolic blood pressure as a measure of safety|Change from Baseline in systolic and diastolic blood pressure as a measure of safety|Absolute values for heart rate as a measure of safety|Change from Baseline in Heart rate as a measure of safety","IV iron use for all subjects will be recorded in the electronic case record form (eCRF) and the average monthly IV iron dose up to Week 52 while on treatment will be calculated.|AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is medically significant. Along with AE and SAE the study will also assess AESI and MACE events until follow-up Week 52.|Subjects will be treated to achieve and maintain Hgb between 10 and 11.5 grams/deciliter. The study treatment may be dose-titrated, if needed, during EP to achieve or maintain Hgb level in the target range.|A rescue algorithm is provided to minimize subjects having an inadequate response to the treatment for their anemia for an extended period of time and to enable consistency in the application of rescue therapy across the study. The time to stopping of study treatment due to subjects meeting the rescue criteria will be assessed. The date and time of rescue medication administration as well as the name and dosage regimen of the rescue medication must be recorded.|A responder is defined as a subject with mean Hgb within the Hgb analysis range 10 to 11.5 grams/deciliter during the EP. Subjects will be treated to achieve and maintain Hgb between 10 and 11.5 grams/deciliter. The study treatment may be dose-titrated, if needed, during EP to achieve or maintain Hgb level in the target range.|MAP is an average BP in an individual during a single cardiac cycle. Measurements will be taken both pre-dialysis and post-dialysis. Measurements will be taken with the subject is in a semi-supine or seated position in the dialysis chair after at least a 5-minute rest period, pre- and post-dialysis. Measurement of SBP, DBP and MAP will be performed before collection of blood samples for laboratory testing, where applicable.|The calculation of events per subject-years is the number of incident cases divided by the amount of subjects-time at risk. Number of BP exacerbation events per 100 subject years will be calculated.|Number of subjects with at least 1 BP exacerbation event up to Week 52 will be calculated.|Blood samples (6 in total) will be collected at the Day 1 visit pre-dose and at any one post-Baseline visit between Week 8 and Week 52.|Change from Baseline in global symptom severity will be assessed. Symptom severity will be assessed using the PGI-S. The PGI-S is a 1-item questionnaire designed to assess subjects impression of disease severity of their anemia of CKD.|The following hematology parameters will be measured: Hemoglobin, Hematocrit, RBC count, Mean corpuscular volume (MCV), Mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), Red cell distribution width (RDW), Reticulocyte count, Platelet count, white blood cell (WBC) count, Total neutrophils, Eosinophils, Monocytes, Basophils, and Lymphocytes|The following chemistry parameters will be measured: Potassium, Albumin, Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Calcium, Phosphate, Total and direct/indirect bilirubin, and urea (serum).|Measurements will be taken both pre-dialysis and post-dialysis. Measurements will be taken with the subject is in a semi-supine or seated position in the dialysis chair after at least a 5-minute rest period, pre and post-dialysis. Measurement of SBP and DBP will be performed before collection of blood samples for laboratory testing, where applicable.|Measurements will be taken both pre-dialysis and post-dialysis. Measurements will be taken with the subject is in a semi-supine or seated position in the dialysis chair after at least a 5-minute rest period, pre and post-dialysis. Measurement of heart rate will be performed before collection of blood samples for laboratory testing, where applicable.","Up to Week 52|Weeks 28 to 52|Baseline and Week 52|Pre-dose at any one post-Baseline visit between Week 8 and Week 52|Pre-dose and 0.5, 1, 2, 3 hours|Pre-dose and 0.5, 1, 2, 3 hours post-dose|Baseline and up to Week 52","GSKClinicalSupportHD@gsk.com","US GSK Clinical Trials Call Center","877-379-3718",{"$nulls":7},"GSK Clinical Trials","2018-03-01","2020-05-25T16:36:55.352","2020-05-26T17:10:42.972","NCT03400033"]
["5ecbf42711702c1b1b916a74","NCT03400033","2018-04-06","GlaxoSmithKline","GSK","Not yet recruiting","Anemia Studies in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat-Three-times Weekly Dosing in Dialysis (ASCEND-TD)","Daprodustat|Epoetin alfa","HIF Inhibitor|ESA Activator","Yes","['Daprodustat', 'Epoetin alfa']","Yes","['HIF Inhibitor']","Phase 3",2,402,"Anticipated","2018-09-10","2020-07-07",{"$nulls":5},"This Phase 3 study in hemodialysis-dependent subjects with anemia will evaluate the efficacy and safety of daprodustat administered three-times weekly compared to epoetin alfa, the current standard of care. This study includes a 4 week Screening Period, a 52 week Treatment Period and a 4 to 6 week follow-up period. Each subject will remain in the study for up to 62 weeks. Approximately 402 subjects will be randomized to receive either daprodustat three times weekly or epoetin alfa three-times weekly or once weekly, depending on dose level.",null,"A Phase 3 Randomized, Double-blind, Active-controlled, Parallel-group, Multi-center Study in Hemodialysis Participants With Anemia of Chronic Kidney Disease to Evaluate the Efficacy, Safety and Pharmacokinetics of Three-times Weekly Dosing of Daprodustat Compared to Recombinant Human Erythropoietin, Following a Switch From Recombinant Human Erythropoietin or Its Analogs",204837,"Anaemia","Anemia","Hematologic Diseases","Heme & Lymph Diseases","Experimental|Active Comparator","Daprodustat|Epoetin alfa","Subjects randomized to this arm will receive daprodustat tablets titrated doses from 2 to 48 milligrams orally three-times weekly along with saline by IV route for the 52 weeks treatment period.|Subjects randomized to this arm will receive matching placebo tablets to daprodustat orally three-times weekly and Epoetin alfa by IV route for the 52 weeks treatment period.","Drug","Daprodustat tablets|Saline vials or bags|Matching placebo tablets|Epoetin alfa vials","Round, biconvex, white, film-coated tablet in unit dose strengths 2 and 4 milligrams (7 millimeter tablets), 6, 8 and 10 milligrams (9 millimeter tablets) administered by the oral route.|0.9% sodium chloride saline vials or bags administered by the IV route.|Matching placebo to daprodustat tablets supplied as round, biconvex, white, film-coated tablet in unit dose strengths 2 and 4 milligrams (7 millimeter tablets), 6, 8 and 10 milligrams (9 millimeter tablets) administered by the oral route.|Single-dose, preservative-free vials in unit dose strengths of 2000, 3000, 4000 and 10,000 Units/milliliter administered by the IV route.",null,"Daprodustat|Epoetin alfa","\n\n * Subject must be 18 to 99 years of age inclusive, at the time of signing the informed consent.\n * Use of any approved rhEPO or analog for at least 8 weeks prior to the screening visit and continuing during the screening period until randomization (Day 1).\n * Hgb concentration (measured by HemoCue) within the following range: Week -4: Hgb 8 to 11.5 grams/deciliter (5 to 7.1 millimoles/liter). If Hgb is 11.6 to 11.9 grams/deciliter (7.2 to 7.4 millimoles/liter), up to two retests are allowed; the retest value must be between 8 to 11.5 grams/deciliter (5 to 7.1 millimoles/liter). Day 1: Hgb 8 to 11 grams/deciliter (5 to 6.8 millimoles/liter) and receiving at least the minimum rhEPO or analog dose 3. Hgb>11 to 11.5 grams/deciliter (6.8 to 7.1 millimoles/liter) and receiving greater than the minimum rhEPO or analog dose 3.\n * On hemodialysis (including hemofiltration or hemodiafiltration) >90 days prior to screening and continuing during the screening period.\n * On hemodialysis (in-center) >=3 times per week.\n * Male and female subjects are eligible. A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: Not a woman of childbearing potential (WOCBP), or A WOCBP who agrees to follow the contraceptive guidance from at least 28 days prior to first dose of study treatment and for at least 28 days after the last dose of study treatment.\n * Capable of giving signed informed consent.\n * In France, a subject will be eligible for inclusion in this study if he or she is either affiliated to or beneficiary of a social security category.\n\n","\n\n * Planned living-related or living-unrelated kidney transplant within 52 weeks after randomization (Day 1).\n * Ferritin: <=100 nanograms/milliliter (<=100 micrograms/liter), at screening.\n * Transferrin saturation (TSAT): <=20 percent, at screening. If TSAT is 18 to 20 percent, then a retest using a new blood sample can be obtained within 7 days of the final laboratory report; the final retest value must be >20 percent to confirm eligibility.\n * Aplasias: History of bone marrow aplasia or pure red cell aplasia.\n * Conditions, other than anemia of CKD, which can affect erythropoiesis.\n * Myocardial infarction (MI) or acute coronary syndrome within 8 weeks prior to screening through to randomization (Day 1).\n * Stroke or transient ischemic attack within 8 weeks prior to screening through to randomization (Day 1).\n * Heart failure (HF): Chronic Class IV HF, as defined by the New York Heart Association (NYHA) functional classification system.\n * Current uncontrolled hypertension as determined by the investigator that would contraindicate the use of rhEPO.\n * Bazett's correction of QTc interval (QTcB): at Day 1: QTcB >500 milliseconds, or QTcB >530 milliseconds in subjects with bundle branch block. There is no QTc (corrected QT) exclusion for subjects with a predominantly ventricular paced rhythm.\n * Liver Disease: presence of any one of the following liver-related laboratory values or conditions, at screening, is exclusionary: ALT >2x upper limit of normal (ULN); Bilirubin >1.5x ULN; or Current unstable liver or biliary disease per investigator assessment, generally defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis.\n * Evidence of actively bleeding gastric, duodenal or esophageal ulcer disease OR clinically significant gastro intestinal bleeding <= 8 weeks prior to screening through to randomization (Day 1).\n * History of malignancy within 2 years prior to screening through to randomization (Day 1), currently receiving treatment for cancer, or complex kidney cyst (e.g., Bosniak Category IIF, III or IV) >3 centimeters.\n * Use of a strong inhibitor of Cytochrome P4502C8 [CYP2C8] (e.g. gemfibrozil) or a strong inducer of CYP2C8 (e.g. rifampin/rifampicin).\n * History of severe allergic or anaphylactic reactions or hypersensitivity to excipients in the investigational product (daprodustat) or epoetin alfa.\n * Use of another investigational agent within 30 days or within five half-lives of the investigational agent (whichever is longer) or currently participating in a study of an investigational device prior to screening through to randomization (Day 1).\n * Any prior treatment with daprodustat for treatment duration of >30 days.\n * Any other condition, clinical or laboratory abnormality, or examination finding that the investigator considers would put the subject at unacceptable risk, which may affect study compliance (e.g. intolerance to rhEPO) or prevent understanding of the aims or investigational procedures or possible consequences of the study.",{"$nulls":4},"Actual","2018-01-17","Actual","Anticipated","2020-07-07","Anticipated","2018-04-01","2018-01-08","2018-01-08","2018-04-05","Yes","CKD, EPO, rhEPO, Hemodialysis dependent, Daprodustat","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years","99 Years","All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":19},"Mean change in Hemoglobin (Hgb) between Baseline and over Evaluation period [EP] (Weeks 28 to 52)","Blood samples will be collected from subjects for Hgb measurements.","Baseline and up to Week 52","Mean monthly intravenous (IV) iron dose per subject up to Week 52|Number of subjects with adverse events (AEs), serious adverse events (SAEs), adverse event of special interest (AESI) and MACE|Percentage of time Hgb will be in the analysis range (10 to 11.5 grams/deciliter) over EP (Weeks 28 to 52)|Time to stopping study treatment due to meeting rescue criteria|Number of responders in the Hgb analysis range over EP (Weeks 28 to 52)|Change from Baseline in SBP, DBP and mean arterial pressure (MAP) at Week 52 and at the end of study treatment|Number of BP exacerbation events per 100 subject years|Number of subjects with at least one BP exacerbation event during the study|Pre-dose trough concentration (Ctau) of daprodustat|Pre-dose Ctau of metabolites M2|Pre-dose Ctau of metabolites M4|Pre-dose Ctau of metabolites M3|Pre-dose Ctau of metabolites M5|Pre-dose Ctau of metabolites M6|Pre-dose Ctau of metabolites M13|Maximum observed concentration (Cmax) of daprodustat|Cmax of metabolites M2|Cmax of metabolites M3|Cmax of metabolites M4|Cmax of metabolites M5|Cmax of metabolites M6|Cmax of metabolites M13|Change from Baseline in Patient Global Impression of Severity (PGI-S) score|Absolute values over time for composite of hematology parameters as a measure of safety|Changes from baseline over time in composite of hematology parameters as a measure of safety|Absolute values over time for composite of chemistry parameters as a measure of safety|Changes from baseline over time in composite of chemistry parameters as a measure of safety|Absolute values of systolic and diastolic blood pressure as a measure of safety|Change from Baseline in systolic and diastolic blood pressure as a measure of safety|Absolute values for heart rate as a measure of safety|Change from Baseline in Heart rate as a measure of safety","IV iron use for all subjects will be recorded in the electronic case record form (eCRF) and the average monthly IV iron dose up to Week 52 while on treatment will be calculated.|AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is medically significant. Along with AE and SAE the study will also assess AESI and MACE events until follow-up Week 52.|Subjects will be treated to achieve and maintain Hgb between 10 and 11.5 grams/deciliter. The study treatment may be dose-titrated, if needed, during EP to achieve or maintain Hgb level in the target range.|A rescue algorithm is provided to minimize subjects having an inadequate response to the treatment for their anemia for an extended period of time and to enable consistency in the application of rescue therapy across the study. The time to stopping of study treatment due to subjects meeting the rescue criteria will be assessed. The date and time of rescue medication administration as well as the name and dosage regimen of the rescue medication must be recorded.|A responder is defined as a subject with mean Hgb within the Hgb analysis range 10 to 11.5 grams/deciliter during the EP. Subjects will be treated to achieve and maintain Hgb between 10 and 11.5 grams/deciliter. The study treatment may be dose-titrated, if needed, during EP to achieve or maintain Hgb level in the target range.|MAP is an average BP in an individual during a single cardiac cycle. Measurements will be taken both pre-dialysis and post-dialysis. Measurements will be taken with the subject is in a semi-supine or seated position in the dialysis chair after at least a 5-minute rest period, pre- and post-dialysis. Measurement of SBP, DBP and MAP will be performed before collection of blood samples for laboratory testing, where applicable.|The calculation of events per subject-years is the number of incident cases divided by the amount of subjects-time at risk. Number of BP exacerbation events per 100 subject years will be calculated.|Number of subjects with at least 1 BP exacerbation event up to Week 52 will be calculated.|Blood samples (6 in total) will be collected at the Day 1 visit pre-dose and at any one post-Baseline visit between Week 8 and Week 52.|Change from Baseline in global symptom severity will be assessed. Symptom severity will be assessed using the PGI-S. The PGI-S is a 1-item questionnaire designed to assess subjects impression of disease severity of their anemia of CKD.|The following hematology parameters will be measured: Hemoglobin, Hematocrit, RBC count, Mean corpuscular volume (MCV), Mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), Red cell distribution width (RDW), Reticulocyte count, Platelet count, white blood cell (WBC) count, Total neutrophils, Eosinophils, Monocytes, Basophils, and Lymphocytes|The following chemistry parameters will be measured: Potassium, Albumin, Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Calcium, Phosphate, Total and direct/indirect bilirubin, and urea (serum).|Measurements will be taken both pre-dialysis and post-dialysis. Measurements will be taken with the subject is in a semi-supine or seated position in the dialysis chair after at least a 5-minute rest period, pre and post-dialysis. Measurement of SBP and DBP will be performed before collection of blood samples for laboratory testing, where applicable.|Measurements will be taken both pre-dialysis and post-dialysis. Measurements will be taken with the subject is in a semi-supine or seated position in the dialysis chair after at least a 5-minute rest period, pre and post-dialysis. Measurement of heart rate will be performed before collection of blood samples for laboratory testing, where applicable.","Up to Week 52|Weeks 28 to 52|Baseline and Week 52|Pre-dose at any one post-Baseline visit between Week 8 and Week 52|Pre-dose and 0.5, 1, 2, 3 hours|Pre-dose and 0.5, 1, 2, 3 hours post-dose|Baseline and up to Week 52","GSKClinicalSupportHD@gsk.com","US GSK Clinical Trials Call Center","877-379-3718",{"$nulls":7},"GSK Clinical Trials","2018-04-05","2020-05-25T16:36:55.475","2020-05-26T17:10:42.972","NCT03400033"]
["5ecbf427307e3d1b1f8d9cf5","NCT03400033","2018-06-06","GlaxoSmithKline","GSK","Not yet recruiting","Anemia Studies in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat-Three-times Weekly Dosing in Dialysis (ASCEND-TD)","Daprodustat|Epoetin alfa","HIF Inhibitor|ESA Activator","Yes","['Daprodustat']","Yes","['HIF Inhibitor']","Phase 3",2,402,"Anticipated","2018-09-10","2020-07-07",{"$nulls":5},"This Phase 3 study in hemodialysis-dependent subjects with anemia will evaluate the efficacy and safety of daprodustat administered three-times weekly compared to epoetin alfa, the current standard of care. This study includes a 4 week Screening Period, a 52 week Treatment Period and a 4 to 6 week follow-up period. Each subject will remain in the study for up to 62 weeks. Approximately 402 subjects will be randomized to receive either daprodustat three times weekly or epoetin alfa three-times weekly or once weekly, depending on dose level.",null,"A Phase 3 Randomized, Double-blind, Active-controlled, Parallel-group, Multi-center Study in Hemodialysis Participants With Anemia of Chronic Kidney Disease to Evaluate the Efficacy, Safety and Pharmacokinetics of Three-times Weekly Dosing of Daprodustat Compared to Recombinant Human Erythropoietin, Following a Switch From Recombinant Human Erythropoietin or Its Analogs",204837,"Anaemia","Anemia","Hematologic Diseases","Heme & Lymph Diseases","Experimental|Active Comparator","Daprodustat|Epoetin alfa","Subjects randomized to this arm will receive daprodustat tablets titrated doses from 2 to 48 milligrams orally three-times weekly along with saline by IV route for the 52 weeks treatment period.|Subjects randomized to this arm will receive matching placebo tablets to daprodustat orally three-times weekly and Epoetin alfa by IV route for the 52 weeks treatment period.","Drug","Daprodustat tablets|Saline vials or bags|Matching placebo tablets|Epoetin alfa vials","Round, biconvex, white, film-coated tablet in unit dose strengths 2 and 4 milligrams (7 millimeter tablets), 6, 8 and 10 milligrams (9 millimeter tablets) administered by the oral route.|0.9% sodium chloride saline vials or bags administered by the IV route.|Matching placebo to daprodustat tablets supplied as round, biconvex, white, film-coated tablet in unit dose strengths 2 and 4 milligrams (7 millimeter tablets), 6, 8 and 10 milligrams (9 millimeter tablets) administered by the oral route.|Single-dose, preservative-free vials in unit dose strengths of 2000, 3000, 4000 and 10,000 Units/milliliter administered by the IV route.",null,"Daprodustat|Epoetin alfa","\n\n * Subject must be 18 to 99 years of age inclusive, at the time of signing the informed consent.\n * Use of any approved rhEPO or analog for at least 8 weeks prior to the screening visit and continuing during the screening period until randomization (Day 1).\n * Hgb concentration (measured by HemoCue) within the following range: Week -4: Hgb 8 to 11.5 grams/deciliter (5 to 7.1 millimoles/liter). If Hgb is 11.6 to 11.9 grams/deciliter (7.2 to 7.4 millimoles/liter), up to two retests are allowed; the retest value must be between 8 to 11.5 grams/deciliter (5 to 7.1 millimoles/liter). Day 1: Hgb 8 to 11 grams/deciliter (5 to 6.8 millimoles/liter) and receiving at least the minimum rhEPO or analog dose 3. Hgb>11 to 11.5 grams/deciliter (6.8 to 7.1 millimoles/liter) and receiving greater than the minimum rhEPO or analog dose 3.\n * On hemodialysis (including hemofiltration or hemodiafiltration) >90 days prior to screening and continuing during the screening period.\n * On hemodialysis (in-center) >=3 times per week.\n * Male and female subjects are eligible. A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: Not a woman of childbearing potential (WOCBP), or A WOCBP who agrees to follow the contraceptive guidance from at least 28 days prior to first dose of study treatment and for at least 28 days after the last dose of study treatment.\n * Capable of giving signed informed consent.\n * In France, a subject will be eligible for inclusion in this study if he or she is either affiliated to or beneficiary of a social security category.\n\n","\n\n * Planned living-related or living-unrelated kidney transplant within 52 weeks after randomization (Day 1).\n * Ferritin: <=100 nanograms/milliliter (<=100 micrograms/liter), at screening.\n * Transferrin saturation (TSAT): <=20 percent, at screening. If TSAT is 18 to 20 percent, then a retest using a new blood sample can be obtained within 7 days of the final laboratory report; the final retest value must be >20 percent to confirm eligibility.\n * Aplasias: History of bone marrow aplasia or pure red cell aplasia.\n * Conditions, other than anemia of CKD, which can affect erythropoiesis.\n * Myocardial infarction (MI) or acute coronary syndrome within 8 weeks prior to screening through to randomization (Day 1).\n * Stroke or transient ischemic attack within 8 weeks prior to screening through to randomization (Day 1).\n * Heart failure (HF): Chronic Class IV HF, as defined by the New York Heart Association (NYHA) functional classification system.\n * Current uncontrolled hypertension as determined by the investigator that would contraindicate the use of rhEPO.\n * Bazett's correction of QTc interval (QTcB): at Day 1: QTcB >500 milliseconds, or QTcB >530 milliseconds in subjects with bundle branch block. There is no QTc (corrected QT) exclusion for subjects with a predominantly ventricular paced rhythm.\n * Liver Disease: presence of any one of the following liver-related laboratory values or conditions, at screening, is exclusionary: ALT >2x upper limit of normal (ULN); Bilirubin >1.5x ULN; or Current unstable liver or biliary disease per investigator assessment, generally defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis.\n * Evidence of actively bleeding gastric, duodenal or esophageal ulcer disease OR clinically significant gastro intestinal bleeding <= 8 weeks prior to screening through to randomization (Day 1).\n * History of malignancy within 2 years prior to screening through to randomization (Day 1), currently receiving treatment for cancer, or complex kidney cyst (e.g., Bosniak Category IIF, III or IV) >3 centimeters.\n * Use of a strong inhibitor of Cytochrome P4502C8 [CYP2C8] (e.g. gemfibrozil) or a strong inducer of CYP2C8 (e.g. rifampin/rifampicin).\n * History of severe allergic or anaphylactic reactions or hypersensitivity to excipients in the investigational product (daprodustat) or epoetin alfa.\n * Use of another investigational agent within 30 days or within five half-lives of the investigational agent (whichever is longer) or currently participating in a study of an investigational device prior to screening through to randomization (Day 1).\n * Any prior treatment with daprodustat for treatment duration of >30 days.\n * Any other condition, clinical or laboratory abnormality, or examination finding that the investigator considers would put the subject at unacceptable risk, which may affect study compliance (e.g. intolerance to rhEPO) or prevent understanding of the aims or investigational procedures or possible consequences of the study.",{"$nulls":4},"Actual","2018-01-17","Actual","Anticipated","2020-07-07","Anticipated","2018-06-01","2018-01-08","2018-01-08","2018-06-05","Yes","CKD, EPO, rhEPO, Hemodialysis dependent, Daprodustat","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years","99 Years","All",null,"No","Yes\nIPD for this study will be made available via the Clinical Study Data Request site.",{"$nulls":3},"Yes","No",{"$nulls":19},"Mean change in Hemoglobin (Hgb) between Baseline and over Evaluation period [EP] (Weeks 28 to 52)","Blood samples will be collected from subjects for Hgb measurements.","Baseline and up to Week 52","Mean monthly intravenous (IV) iron dose per subject up to Week 52|Number of subjects with adverse events (AEs), serious adverse events (SAEs), adverse event of special interest (AESI) and MACE|Percentage of time Hgb will be in the analysis range (10 to 11.5 grams/deciliter) over EP (Weeks 28 to 52)|Time to stopping study treatment due to meeting rescue criteria|Number of responders in the Hgb analysis range over EP (Weeks 28 to 52)|Change from Baseline in SBP, DBP and mean arterial pressure (MAP) at Week 52 and at the end of study treatment|Number of BP exacerbation events per 100 subject years|Number of subjects with at least one BP exacerbation event during the study|Pre-dose trough concentration (Ctau) of daprodustat|Pre-dose Ctau of metabolites M2|Pre-dose Ctau of metabolites M4|Pre-dose Ctau of metabolites M3|Pre-dose Ctau of metabolites M5|Pre-dose Ctau of metabolites M6|Pre-dose Ctau of metabolites M13|Maximum observed concentration (Cmax) of daprodustat|Cmax of metabolites M2|Cmax of metabolites M3|Cmax of metabolites M4|Cmax of metabolites M5|Cmax of metabolites M6|Cmax of metabolites M13|Change from Baseline in Patient Global Impression of Severity (PGI-S) score|Absolute values over time for composite of hematology parameters as a measure of safety|Changes from baseline over time in composite of hematology parameters as a measure of safety|Absolute values over time for composite of chemistry parameters as a measure of safety|Changes from baseline over time in composite of chemistry parameters as a measure of safety|Absolute values of systolic and diastolic blood pressure as a measure of safety|Change from Baseline in systolic and diastolic blood pressure as a measure of safety|Absolute values for heart rate as a measure of safety|Change from Baseline in Heart rate as a measure of safety","IV iron use for all subjects will be recorded in the electronic case record form (eCRF) and the average monthly IV iron dose up to Week 52 while on treatment will be calculated.|AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is medically significant. Along with AE and SAE the study will also assess AESI and MACE events until follow-up Week 52.|Subjects will be treated to achieve and maintain Hgb between 10 and 11.5 grams/deciliter. The study treatment may be dose-titrated, if needed, during EP to achieve or maintain Hgb level in the target range.|A rescue algorithm is provided to minimize subjects having an inadequate response to the treatment for their anemia for an extended period of time and to enable consistency in the application of rescue therapy across the study. The time to stopping of study treatment due to subjects meeting the rescue criteria will be assessed. The date and time of rescue medication administration as well as the name and dosage regimen of the rescue medication must be recorded.|A responder is defined as a subject with mean Hgb within the Hgb analysis range 10 to 11.5 grams/deciliter during the EP. Subjects will be treated to achieve and maintain Hgb between 10 and 11.5 grams/deciliter. The study treatment may be dose-titrated, if needed, during EP to achieve or maintain Hgb level in the target range.|MAP is an average BP in an individual during a single cardiac cycle. Measurements will be taken both pre-dialysis and post-dialysis. Measurements will be taken with the subject is in a semi-supine or seated position in the dialysis chair after at least a 5-minute rest period, pre- and post-dialysis. Measurement of SBP, DBP and MAP will be performed before collection of blood samples for laboratory testing, where applicable.|The calculation of events per subject-years is the number of incident cases divided by the amount of subjects-time at risk. Number of BP exacerbation events per 100 subject years will be calculated.|Number of subjects with at least 1 BP exacerbation event up to Week 52 will be calculated.|Blood samples (6 in total) will be collected at the Day 1 visit pre-dose and at any one post-Baseline visit between Week 8 and Week 52.|Change from Baseline in global symptom severity will be assessed. Symptom severity will be assessed using the PGI-S. The PGI-S is a 1-item questionnaire designed to assess subjects impression of disease severity of their anemia of CKD.|The following hematology parameters will be measured: Hemoglobin, Hematocrit, RBC count, Mean corpuscular volume (MCV), Mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), Red cell distribution width (RDW), Reticulocyte count, Platelet count, white blood cell (WBC) count, Total neutrophils, Eosinophils, Monocytes, Basophils, and Lymphocytes|The following chemistry parameters will be measured: Potassium, Albumin, Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Calcium, Phosphate, Total and direct/indirect bilirubin, and urea (serum).|Measurements will be taken both pre-dialysis and post-dialysis. Measurements will be taken with the subject is in a semi-supine or seated position in the dialysis chair after at least a 5-minute rest period, pre and post-dialysis. Measurement of SBP and DBP will be performed before collection of blood samples for laboratory testing, where applicable.|Measurements will be taken both pre-dialysis and post-dialysis. Measurements will be taken with the subject is in a semi-supine or seated position in the dialysis chair after at least a 5-minute rest period, pre and post-dialysis. Measurement of heart rate will be performed before collection of blood samples for laboratory testing, where applicable.","Up to Week 52|Weeks 28 to 52|Baseline and Week 52|Pre-dose at any one post-Baseline visit between Week 8 and Week 52|Pre-dose and 0.5, 1, 2, 3 hours|Pre-dose and 0.5, 1, 2, 3 hours post-dose|Baseline and up to Week 52","GSKClinicalSupportHD@gsk.com","US GSK Clinical Trials Call Center","877-379-3718",{"$nulls":7},"GSK Clinical Trials","2018-06-05","2020-05-25T16:36:55.843","2020-05-26T17:10:42.972","NCT03400033"]
["5ecbf427fe30261b1a048265","NCT03400033","2018-07-06","GlaxoSmithKline","GSK","Not yet recruiting","Anemia Studies in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat-Three-times Weekly Dosing in Dialysis (ASCEND-TD)","Daprodustat|Epoetin alfa","HIF Inhibitor|ESA Activator","Yes","['Daprodustat']","Yes","['HIF Inhibitor']","Phase 3",2,402,"Anticipated","2018-09-10","2020-07-07",{"$nulls":5},"This Phase 3 study in hemodialysis-dependent subjects with anemia will evaluate the efficacy and safety of daprodustat administered three-times weekly compared to epoetin alfa, the current standard of care. This study includes a 4 week Screening Period, a 52 week Treatment Period and a 4 to 6 week follow-up period. Each subject will remain in the study for up to 62 weeks. Approximately 402 subjects will be randomized to receive either daprodustat three times weekly or epoetin alfa three-times weekly or once weekly, depending on dose level.",null,"A Phase 3 Randomized, Double-blind, Active-controlled, Parallel-group, Multi-center Study in Hemodialysis Participants With Anemia of Chronic Kidney Disease to Evaluate the Efficacy, Safety and Pharmacokinetics of Three-times Weekly Dosing of Daprodustat Compared to Recombinant Human Erythropoietin, Following a Switch From Recombinant Human Erythropoietin or Its Analogs",204837,"Anaemia","Anemia","Hematologic Diseases","Heme & Lymph Diseases","Experimental|Active Comparator","Daprodustat|Epoetin alfa","Subjects randomized to this arm will receive daprodustat tablets titrated doses from 2 to 48 milligrams orally three-times weekly along with saline by IV route for the 52 weeks treatment period.|Subjects randomized to this arm will receive matching placebo tablets to daprodustat orally three-times weekly and Epoetin alfa by IV route for the 52 weeks treatment period.","Drug","Daprodustat tablets|Saline vials or bags|Matching placebo tablets|Epoetin alfa vials","Round, biconvex, white, film-coated tablet in unit dose strengths 2 and 4 milligrams (7 millimeter tablets), 6, 8 and 10 milligrams (9 millimeter tablets) administered by the oral route.|0.9% sodium chloride saline vials or bags administered by the IV route.|Matching placebo to daprodustat tablets supplied as round, biconvex, white, film-coated tablet in unit dose strengths 2 and 4 milligrams (7 millimeter tablets), 6, 8 and 10 milligrams (9 millimeter tablets) administered by the oral route.|Single-dose, preservative-free vials in unit dose strengths of 2000, 3000, 4000 and 10,000 Units/milliliter administered by the IV route.",null,"Daprodustat|Epoetin alfa","\n\n * Subject must be 18 to 99 years of age inclusive, at the time of signing the informed consent.\n * Use of any approved rhEPO or analog for at least 8 weeks prior to the screening visit and continuing during the screening period until randomization (Day 1).\n * Hgb concentration (measured by HemoCue) within the following range: Week -4: Hgb 8 to 11.5 grams/deciliter (5 to 7.1 millimoles/liter). If Hgb is 11.6 to 11.9 grams/deciliter (7.2 to 7.4 millimoles/liter), up to two retests are allowed; the retest value must be between 8 to 11.5 grams/deciliter (5 to 7.1 millimoles/liter). Day 1: Hgb 8 to 11 grams/deciliter (5 to 6.8 millimoles/liter) and receiving at least the minimum rhEPO or analog dose 3. Hgb>11 to 11.5 grams/deciliter (6.8 to 7.1 millimoles/liter) and receiving greater than the minimum rhEPO or analog dose 3.\n * On hemodialysis (including hemofiltration or hemodiafiltration) >90 days prior to screening and continuing during the screening period.\n * On hemodialysis (in-center) >=3 times per week.\n * Male and female subjects are eligible. A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: Not a woman of childbearing potential (WOCBP), or A WOCBP who agrees to follow the contraceptive guidance from at least 28 days prior to first dose of study treatment and for at least 28 days after the last dose of study treatment.\n * Capable of giving signed informed consent.\n * In France, a subject will be eligible for inclusion in this study if he or she is either affiliated to or beneficiary of a social security category.\n\n","\n\n * Planned living-related or living-unrelated kidney transplant within 52 weeks after randomization (Day 1).\n * Ferritin: <=100 nanograms/milliliter (<=100 micrograms/liter), at screening.\n * Transferrin saturation (TSAT): <=20 percent, at screening. If TSAT is 18 to 20 percent, then a retest using a new blood sample can be obtained within 7 days of the final laboratory report; the final retest value must be >20 percent to confirm eligibility.\n * Aplasias: History of bone marrow aplasia or pure red cell aplasia.\n * Conditions, other than anemia of CKD, which can affect erythropoiesis.\n * Myocardial infarction (MI) or acute coronary syndrome within 8 weeks prior to screening through to randomization (Day 1).\n * Stroke or transient ischemic attack within 8 weeks prior to screening through to randomization (Day 1).\n * Heart failure (HF): Chronic Class IV HF, as defined by the New York Heart Association (NYHA) functional classification system.\n * Current uncontrolled hypertension as determined by the investigator that would contraindicate the use of rhEPO.\n * Bazett's correction of QTc interval (QTcB): at Day 1: QTcB >500 milliseconds, or QTcB >530 milliseconds in subjects with bundle branch block. There is no QTc (corrected QT) exclusion for subjects with a predominantly ventricular paced rhythm.\n * Liver Disease: presence of any one of the following liver-related laboratory values or conditions, at screening, is exclusionary: ALT >2x upper limit of normal (ULN); Bilirubin >1.5x ULN; or Current unstable liver or biliary disease per investigator assessment, generally defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis.\n * Evidence of actively bleeding gastric, duodenal or esophageal ulcer disease OR clinically significant gastro intestinal bleeding <= 8 weeks prior to screening through to randomization (Day 1).\n * History of malignancy within 2 years prior to screening through to randomization (Day 1), currently receiving treatment for cancer, or complex kidney cyst (e.g., Bosniak Category IIF, III or IV) >3 centimeters.\n * Use of a strong inhibitor of Cytochrome P4502C8 [CYP2C8] (e.g. gemfibrozil) or a strong inducer of CYP2C8 (e.g. rifampin/rifampicin).\n * History of severe allergic or anaphylactic reactions or hypersensitivity to excipients in the investigational product (daprodustat) or epoetin alfa.\n * Use of another investigational agent within 30 days or within five half-lives of the investigational agent (whichever is longer) or currently participating in a study of an investigational device prior to screening through to randomization (Day 1).\n * Any prior treatment with daprodustat for treatment duration of >30 days.\n * Any other condition, clinical or laboratory abnormality, or examination finding that the investigator considers would put the subject at unacceptable risk, which may affect study compliance (e.g. intolerance to rhEPO) or prevent understanding of the aims or investigational procedures or possible consequences of the study.",{"$nulls":4},"Actual","2018-01-17","Actual","Anticipated","2020-07-07","Anticipated","2018-07-01","2018-01-08","2018-01-08","2018-07-05","Yes","CKD, EPO, rhEPO, Hemodialysis dependent, Daprodustat","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years","99 Years","All",null,"No","Yes\nIPD for this study will be made available via the Clinical Study Data Request site.",{"$nulls":3},"Yes","No",{"$nulls":19},"Mean change in Hemoglobin (Hgb) between Baseline and over Evaluation period [EP] (Weeks 28 to 52)","Blood samples will be collected from subjects for Hgb measurements.","Baseline and up to Week 52","Mean monthly intravenous (IV) iron dose per subject up to Week 52|Number of subjects with adverse events (AEs), serious adverse events (SAEs), adverse event of special interest (AESI) and MACE|Percentage of time Hgb will be in the analysis range (10 to 11.5 grams/deciliter) over EP (Weeks 28 to 52)|Time to stopping study treatment due to meeting rescue criteria|Number of responders in the Hgb analysis range over EP (Weeks 28 to 52)|Change from Baseline in SBP, DBP and mean arterial pressure (MAP) at Week 52 and at the end of study treatment|Number of BP exacerbation events per 100 subject years|Number of subjects with at least one BP exacerbation event during the study|Pre-dose trough concentration (Ctau) of daprodustat|Pre-dose Ctau of metabolites M2|Pre-dose Ctau of metabolites M4|Pre-dose Ctau of metabolites M3|Pre-dose Ctau of metabolites M5|Pre-dose Ctau of metabolites M6|Pre-dose Ctau of metabolites M13|Maximum observed concentration (Cmax) of daprodustat|Cmax of metabolites M2|Cmax of metabolites M3|Cmax of metabolites M4|Cmax of metabolites M5|Cmax of metabolites M6|Cmax of metabolites M13|Change from Baseline in Patient Global Impression of Severity (PGI-S) score|Absolute values over time for composite of hematology parameters as a measure of safety|Changes from baseline over time in composite of hematology parameters as a measure of safety|Absolute values over time for composite of chemistry parameters as a measure of safety|Changes from baseline over time in composite of chemistry parameters as a measure of safety|Absolute values of systolic and diastolic blood pressure as a measure of safety|Change from Baseline in systolic and diastolic blood pressure as a measure of safety|Absolute values for heart rate as a measure of safety|Change from Baseline in Heart rate as a measure of safety","IV iron use for all subjects will be recorded in the electronic case record form (eCRF) and the average monthly IV iron dose up to Week 52 while on treatment will be calculated.|AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is medically significant. Along with AE and SAE the study will also assess AESI and MACE events until follow-up Week 52.|Subjects will be treated to achieve and maintain Hgb between 10 and 11.5 grams/deciliter. The study treatment may be dose-titrated, if needed, during EP to achieve or maintain Hgb level in the target range.|A rescue algorithm is provided to minimize subjects having an inadequate response to the treatment for their anemia for an extended period of time and to enable consistency in the application of rescue therapy across the study. The time to stopping of study treatment due to subjects meeting the rescue criteria will be assessed. The date and time of rescue medication administration as well as the name and dosage regimen of the rescue medication must be recorded.|A responder is defined as a subject with mean Hgb within the Hgb analysis range 10 to 11.5 grams/deciliter during the EP. Subjects will be treated to achieve and maintain Hgb between 10 and 11.5 grams/deciliter. The study treatment may be dose-titrated, if needed, during EP to achieve or maintain Hgb level in the target range.|MAP is an average BP in an individual during a single cardiac cycle. Measurements will be taken both pre-dialysis and post-dialysis. Measurements will be taken with the subject is in a semi-supine or seated position in the dialysis chair after at least a 5-minute rest period, pre- and post-dialysis. Measurement of SBP, DBP and MAP will be performed before collection of blood samples for laboratory testing, where applicable.|The calculation of events per subject-years is the number of incident cases divided by the amount of subjects-time at risk. Number of BP exacerbation events per 100 subject years will be calculated.|Number of subjects with at least 1 BP exacerbation event up to Week 52 will be calculated.|Blood samples (6 in total) will be collected at the Day 1 visit pre-dose and at any one post-Baseline visit between Week 8 and Week 52.|Change from Baseline in global symptom severity will be assessed. Symptom severity will be assessed using the PGI-S. The PGI-S is a 1-item questionnaire designed to assess subjects impression of disease severity of their anemia of CKD.|The following hematology parameters will be measured: Hemoglobin, Hematocrit, RBC count, Mean corpuscular volume (MCV), Mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), Red cell distribution width (RDW), Reticulocyte count, Platelet count, white blood cell (WBC) count, Total neutrophils, Eosinophils, Monocytes, Basophils, and Lymphocytes|The following chemistry parameters will be measured: Potassium, Albumin, Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Calcium, Phosphate, Total and direct/indirect bilirubin, and urea (serum).|Measurements will be taken both pre-dialysis and post-dialysis. Measurements will be taken with the subject is in a semi-supine or seated position in the dialysis chair after at least a 5-minute rest period, pre and post-dialysis. Measurement of SBP and DBP will be performed before collection of blood samples for laboratory testing, where applicable.|Measurements will be taken both pre-dialysis and post-dialysis. Measurements will be taken with the subject is in a semi-supine or seated position in the dialysis chair after at least a 5-minute rest period, pre and post-dialysis. Measurement of heart rate will be performed before collection of blood samples for laboratory testing, where applicable.","Up to Week 52|Weeks 28 to 52|Baseline and Week 52|Pre-dose at any one post-Baseline visit between Week 8 and Week 52|Pre-dose and 0.5, 1, 2, 3 hours|Pre-dose and 0.5, 1, 2, 3 hours post-dose|Baseline and up to Week 52","GSKClinicalSupportHD@gsk.com","US GSK Clinical Trials Call Center","877-379-3718",{"$nulls":7},"GSK Clinical Trials","2018-07-05","2020-05-25T16:36:55.875","2020-05-26T17:10:42.972","NCT03400033"]
["5ecbf428e2561b1b11905d61","NCT03400033","2018-09-05","GlaxoSmithKline","GSK","Not yet recruiting","Anemia Studies in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat-Three-times Weekly Dosing in Dialysis (ASCEND-TD)","Daprodustat|Epoetin alfa","HIF Inhibitor|ESA Activator","Yes","['Daprodustat']","Yes","['HIF Inhibitor']","Phase 3",2,402,"Anticipated","2018-09-10","2020-07-07",{"$nulls":5},"This Phase 3 study in hemodialysis-dependent subjects with anemia will evaluate the efficacy and safety of daprodustat administered three-times weekly compared to epoetin alfa, the current standard of care. This study includes a 4 week Screening Period, a 52 week Treatment Period and a 4 to 6 week follow-up period. Each subject will remain in the study for up to 62 weeks. Approximately 402 subjects will be randomized to receive either daprodustat three times weekly or epoetin alfa three-times weekly or once weekly, depending on dose level.",null,"A Phase 3 Randomized, Double-blind, Active-controlled, Parallel-group, Multi-center Study in Hemodialysis Participants With Anemia of Chronic Kidney Disease to Evaluate the Efficacy, Safety and Pharmacokinetics of Three-times Weekly Dosing of Daprodustat Compared to Recombinant Human Erythropoietin, Following a Switch From Recombinant Human Erythropoietin or Its Analogs",204837,"Anaemia","Anemia","Hematologic Diseases","Heme & Lymph Diseases","Experimental|Active Comparator","Daprodustat|Epoetin alfa","Subjects randomized to this arm will receive daprodustat tablets titrated doses from 2 to 48 milligrams orally three-times weekly along with saline by IV route for the 52 weeks treatment period.|Subjects randomized to this arm will receive matching placebo tablets to daprodustat orally three-times weekly and Epoetin alfa by IV route for the 52 weeks treatment period.","Drug","Daprodustat tablets|Saline vials or bags|Matching placebo tablets|Epoetin alfa vials","Round, biconvex, white, film-coated tablet in unit dose strengths 2 and 4 milligrams (7 millimeter tablets), 6, 8 and 10 milligrams (9 millimeter tablets) administered by the oral route.|0.9% sodium chloride saline vials or bags administered by the IV route.|Matching placebo to daprodustat tablets supplied as round, biconvex, white, film-coated tablet in unit dose strengths 2 and 4 milligrams (7 millimeter tablets), 6, 8 and 10 milligrams (9 millimeter tablets) administered by the oral route.|Single-dose, preservative-free vials in unit dose strengths of 2000, 3000, 4000 and 10,000 Units/milliliter administered by the IV route.",null,"Daprodustat|Epoetin alfa","\n\n * Subject must be 18 to 99 years of age inclusive, at the time of signing the informed consent.\n * Use of any approved rhEPO or analog for at least 8 weeks prior to the screening visit and continuing during the screening period until randomization (Day 1).\n * Hgb concentration (measured by HemoCue) within the following range: Week -4: Hgb 8 to 11.5 grams/deciliter (5 to 7.1 millimoles/liter). If Hgb is 11.6 to 11.9 grams/deciliter (7.2 to 7.4 millimoles/liter), up to two retests are allowed; the retest value must be between 8 to 11.5 grams/deciliter (5 to 7.1 millimoles/liter). Day 1: Hgb 8 to 11 grams/deciliter (5 to 6.8 millimoles/liter) and receiving at least the minimum rhEPO or analog dose 3. Hgb>11 to 11.5 grams/deciliter (6.8 to 7.1 millimoles/liter) and receiving greater than the minimum rhEPO or analog dose 3.\n * On hemodialysis (including hemofiltration or hemodiafiltration) >90 days prior to screening and continuing during the screening period.\n * On hemodialysis (in-center) >=3 times per week.\n * Male and female subjects are eligible. A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: Not a woman of childbearing potential (WOCBP), or A WOCBP who agrees to follow the contraceptive guidance from at least 28 days prior to first dose of study treatment and for at least 28 days after the last dose of study treatment.\n * Capable of giving signed informed consent.\n * In France, a subject will be eligible for inclusion in this study if he or she is either affiliated to or beneficiary of a social security category.\n\n","\n\n * Planned living-related or living-unrelated kidney transplant within 52 weeks after randomization (Day 1).\n * Ferritin: <=100 nanograms/milliliter (<=100 micrograms/liter), at screening.\n * Transferrin saturation (TSAT): <=20 percent, at screening. If TSAT is 18 to 20 percent, then a retest using a new blood sample can be obtained within 7 days of the final laboratory report; the final retest value must be >20 percent to confirm eligibility.\n * Aplasias: History of bone marrow aplasia or pure red cell aplasia.\n * Conditions, other than anemia of CKD, which can affect erythropoiesis.\n * Myocardial infarction (MI) or acute coronary syndrome within 8 weeks prior to screening through to randomization (Day 1).\n * Stroke or transient ischemic attack within 8 weeks prior to screening through to randomization (Day 1).\n * Heart failure (HF): Chronic Class IV HF, as defined by the New York Heart Association (NYHA) functional classification system.\n * Current uncontrolled hypertension as determined by the investigator that would contraindicate the use of rhEPO.\n * Bazett's correction of QTc interval (QTcB): at Day 1: QTcB >500 milliseconds, or QTcB >530 milliseconds in subjects with bundle branch block. There is no QTc (corrected QT) exclusion for subjects with a predominantly ventricular paced rhythm.\n * Liver Disease: presence of any one of the following liver-related laboratory values or conditions, at screening, is exclusionary: ALT >2x upper limit of normal (ULN); Bilirubin >1.5x ULN; or Current unstable liver or biliary disease per investigator assessment, generally defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis.\n * Evidence of actively bleeding gastric, duodenal or esophageal ulcer disease OR clinically significant gastro intestinal bleeding <= 8 weeks prior to screening through to randomization (Day 1).\n * History of malignancy within 2 years prior to screening through to randomization (Day 1), currently receiving treatment for cancer, or complex kidney cyst (e.g., Bosniak Category IIF, III or IV) >3 centimeters.\n * Use of a strong inhibitor of Cytochrome P4502C8 [CYP2C8] (e.g. gemfibrozil) or a strong inducer of CYP2C8 (e.g. rifampin/rifampicin).\n * History of severe allergic or anaphylactic reactions or hypersensitivity to excipients in the investigational product (daprodustat) or epoetin alfa.\n * Use of another investigational agent within 30 days or within five half-lives of the investigational agent (whichever is longer) or currently participating in a study of an investigational device prior to screening through to randomization (Day 1).\n * Any prior treatment with daprodustat for treatment duration of >30 days.\n * Any other condition, clinical or laboratory abnormality, or examination finding that the investigator considers would put the subject at unacceptable risk, which may affect study compliance (e.g. intolerance to rhEPO) or prevent understanding of the aims or investigational procedures or possible consequences of the study.",{"$nulls":4},"Actual","2018-01-17","Actual","Anticipated","2020-07-07","Anticipated","2018-09-01","2018-01-08","2018-01-08","2018-09-04","Yes","CKD, EPO, rhEPO, Hemodialysis dependent, Daprodustat","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years","99 Years","All",null,"No","Yes\nIPD for this study will be made available via the Clinical Study Data Request site.",{"$nulls":3},"Yes","No",{"$nulls":19},"Mean change in Hemoglobin (Hgb) between Baseline and over Evaluation period [EP] (Weeks 28 to 52)","Blood samples will be collected from subjects for Hgb measurements.","Baseline and up to Week 52","Mean monthly intravenous (IV) iron dose per subject up to Week 52|Number of subjects with adverse events (AEs), serious adverse events (SAEs), adverse event of special interest (AESI) and MACE|Percentage of time Hgb will be in the analysis range (10 to 11.5 grams/deciliter) over EP (Weeks 28 to 52)|Time to stopping study treatment due to meeting rescue criteria|Number of responders in the Hgb analysis range over EP (Weeks 28 to 52)|Change from Baseline in SBP, DBP and mean arterial pressure (MAP) at Week 52 and at the end of study treatment|Number of BP exacerbation events per 100 subject years|Number of subjects with at least one BP exacerbation event during the study|Pre-dose trough concentration (Ctau) of daprodustat|Pre-dose Ctau of metabolites M2|Pre-dose Ctau of metabolites M4|Pre-dose Ctau of metabolites M3|Pre-dose Ctau of metabolites M5|Pre-dose Ctau of metabolites M6|Pre-dose Ctau of metabolites M13|Maximum observed concentration (Cmax) of daprodustat|Cmax of metabolites M2|Cmax of metabolites M3|Cmax of metabolites M4|Cmax of metabolites M5|Cmax of metabolites M6|Cmax of metabolites M13|Change from Baseline in Patient Global Impression of Severity (PGI-S) score|Absolute values over time for composite of hematology parameters as a measure of safety|Changes from baseline over time in composite of hematology parameters as a measure of safety|Absolute values over time for composite of chemistry parameters as a measure of safety|Changes from baseline over time in composite of chemistry parameters as a measure of safety|Absolute values of systolic and diastolic blood pressure as a measure of safety|Change from Baseline in systolic and diastolic blood pressure as a measure of safety|Absolute values for heart rate as a measure of safety|Change from Baseline in Heart rate as a measure of safety","IV iron use for all subjects will be recorded in the electronic case record form (eCRF) and the average monthly IV iron dose up to Week 52 while on treatment will be calculated.|AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is medically significant. Along with AE and SAE the study will also assess AESI and MACE events until follow-up Week 52.|Subjects will be treated to achieve and maintain Hgb between 10 and 11.5 grams/deciliter. The study treatment may be dose-titrated, if needed, during EP to achieve or maintain Hgb level in the target range.|A rescue algorithm is provided to minimize subjects having an inadequate response to the treatment for their anemia for an extended period of time and to enable consistency in the application of rescue therapy across the study. The time to stopping of study treatment due to subjects meeting the rescue criteria will be assessed. The date and time of rescue medication administration as well as the name and dosage regimen of the rescue medication must be recorded.|A responder is defined as a subject with mean Hgb within the Hgb analysis range 10 to 11.5 grams/deciliter during the EP. Subjects will be treated to achieve and maintain Hgb between 10 and 11.5 grams/deciliter. The study treatment may be dose-titrated, if needed, during EP to achieve or maintain Hgb level in the target range.|MAP is an average BP in an individual during a single cardiac cycle. Measurements will be taken both pre-dialysis and post-dialysis. Measurements will be taken with the subject is in a semi-supine or seated position in the dialysis chair after at least a 5-minute rest period, pre- and post-dialysis. Measurement of SBP, DBP and MAP will be performed before collection of blood samples for laboratory testing, where applicable.|The calculation of events per subject-years is the number of incident cases divided by the amount of subjects-time at risk. Number of BP exacerbation events per 100 subject years will be calculated.|Number of subjects with at least 1 BP exacerbation event up to Week 52 will be calculated.|Blood samples (6 in total) will be collected at the Day 1 visit pre-dose and at any one post-Baseline visit between Week 8 and Week 52.|Change from Baseline in global symptom severity will be assessed. Symptom severity will be assessed using the PGI-S. The PGI-S is a 1-item questionnaire designed to assess subjects impression of disease severity of their anemia of CKD.|The following hematology parameters will be measured: Hemoglobin, Hematocrit, RBC count, Mean corpuscular volume (MCV), Mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), Red cell distribution width (RDW), Reticulocyte count, Platelet count, white blood cell (WBC) count, Total neutrophils, Eosinophils, Monocytes, Basophils, and Lymphocytes|The following chemistry parameters will be measured: Potassium, Albumin, Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Calcium, Phosphate, Total and direct/indirect bilirubin, and urea (serum).|Measurements will be taken both pre-dialysis and post-dialysis. Measurements will be taken with the subject is in a semi-supine or seated position in the dialysis chair after at least a 5-minute rest period, pre and post-dialysis. Measurement of SBP and DBP will be performed before collection of blood samples for laboratory testing, where applicable.|Measurements will be taken both pre-dialysis and post-dialysis. Measurements will be taken with the subject is in a semi-supine or seated position in the dialysis chair after at least a 5-minute rest period, pre and post-dialysis. Measurement of heart rate will be performed before collection of blood samples for laboratory testing, where applicable.","Up to Week 52|Weeks 28 to 52|Baseline and Week 52|Pre-dose at any one post-Baseline visit between Week 8 and Week 52|Pre-dose and 0.5, 1, 2, 3 hours|Pre-dose and 0.5, 1, 2, 3 hours post-dose|Baseline and up to Week 52","GSKClinicalSupportHD@gsk.com","US GSK Clinical Trials Call Center","877-379-3718","Heidelberg, Victoria, Australia, 3084|Kansas City, Missouri, United States, 64111","Missouri","Australia|United States","Victoria Gsk Investigational Site|Gsk Investigational Site",{"$nulls":3},"GSK Clinical Trials","2018-09-04","2020-05-25T16:36:56.295","2020-05-26T17:10:42.972","NCT03400033"]
["5ecbf428feab101b15530896","NCT03400033","2018-09-18","GlaxoSmithKline","GSK","Recruiting","Anemia Studies in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat-Three-times Weekly Dosing in Dialysis (ASCEND-TD)","Daprodustat|Epoetin alfa","HIF Inhibitor|ESA Activator","Yes","['Daprodustat']","Yes","['HIF Inhibitor']","Phase 3",2,402,"Anticipated","2018-09-05","2020-07-07",{"$nulls":5},"This Phase 3 study in hemodialysis-dependent subjects with anemia will evaluate the efficacy and safety of daprodustat administered three-times weekly compared to epoetin alfa, the current standard of care. This study includes a 4 week Screening Period, a 52 week Treatment Period and a 4 to 6 week follow-up period. Each subject will remain in the study for up to 62 weeks. Approximately 402 subjects will be randomized to receive either daprodustat three times weekly or epoetin alfa three-times weekly or once weekly, depending on dose level.",null,"A Phase 3 Randomized, Double-blind, Active-controlled, Parallel-group, Multi-center Study in Hemodialysis Participants With Anemia of Chronic Kidney Disease to Evaluate the Efficacy, Safety and Pharmacokinetics of Three-times Weekly Dosing of Daprodustat Compared to Recombinant Human Erythropoietin, Following a Switch From Recombinant Human Erythropoietin or Its Analogs",204837,"Anaemia","Anemia","Hematologic Diseases","Heme & Lymph Diseases","Experimental|Active Comparator","Daprodustat|Epoetin alfa","Subjects randomized to this arm will receive daprodustat tablets titrated doses from 2 to 48 milligrams orally three-times weekly along with saline by IV route for the 52 weeks treatment period.|Subjects randomized to this arm will receive matching placebo tablets to daprodustat orally three-times weekly and Epoetin alfa by IV route for the 52 weeks treatment period.","Drug","Daprodustat tablets|Saline vials or bags|Matching placebo tablets|Epoetin alfa vials","Round, biconvex, white, film-coated tablet in unit dose strengths 2 and 4 milligrams (7 millimeter tablets), 6, 8 and 10 milligrams (9 millimeter tablets) administered by the oral route.|0.9% sodium chloride saline vials or bags administered by the IV route.|Matching placebo to daprodustat tablets supplied as round, biconvex, white, film-coated tablet in unit dose strengths 2 and 4 milligrams (7 millimeter tablets), 6, 8 and 10 milligrams (9 millimeter tablets) administered by the oral route.|Single-dose, preservative-free vials in unit dose strengths of 2000, 3000, 4000 and 10,000 Units/milliliter administered by the IV route.",null,"Daprodustat|Epoetin alfa","\n\n * Subject must be 18 to 99 years of age inclusive, at the time of signing the informed consent.\n * Use of any approved rhEPO or analog for at least 8 weeks prior to the screening visit and continuing during the screening period until randomization (Day 1).\n * Hgb concentration (measured by HemoCue) within the following range: Week -4: Hgb 8 to 11.5 grams/deciliter (5 to 7.1 millimoles/liter). If Hgb is 11.6 to 11.9 grams/deciliter (7.2 to 7.4 millimoles/liter), up to two retests are allowed; the retest value must be between 8 to 11.5 grams/deciliter (5 to 7.1 millimoles/liter). Day 1: Hgb 8 to 11 grams/deciliter (5 to 6.8 millimoles/liter) and receiving at least the minimum rhEPO or analog dose 3. Hgb>11 to 11.5 grams/deciliter (6.8 to 7.1 millimoles/liter) and receiving greater than the minimum rhEPO or analog dose 3.\n * On hemodialysis (including hemofiltration or hemodiafiltration) >90 days prior to screening and continuing during the screening period.\n * On hemodialysis (in-center) >=3 times per week.\n * Male and female subjects are eligible. A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: Not a woman of childbearing potential (WOCBP), or A WOCBP who agrees to follow the contraceptive guidance from at least 28 days prior to first dose of study treatment and for at least 28 days after the last dose of study treatment.\n * Capable of giving signed informed consent.\n * In France, a subject will be eligible for inclusion in this study if he or she is either affiliated to or beneficiary of a social security category.\n\n","\n\n * Planned living-related or living-unrelated kidney transplant within 52 weeks after randomization (Day 1).\n * Ferritin: <=100 nanograms/milliliter (<=100 micrograms/liter), at screening.\n * Transferrin saturation (TSAT): <=20 percent, at screening. If TSAT is 18 to 20 percent, then a retest using a new blood sample can be obtained within 7 days of the final laboratory report; the final retest value must be >20 percent to confirm eligibility.\n * Aplasias: History of bone marrow aplasia or pure red cell aplasia.\n * Conditions, other than anemia of CKD, which can affect erythropoiesis.\n * Myocardial infarction (MI) or acute coronary syndrome within 8 weeks prior to screening through to randomization (Day 1).\n * Stroke or transient ischemic attack within 8 weeks prior to screening through to randomization (Day 1).\n * Heart failure (HF): Chronic Class IV HF, as defined by the New York Heart Association (NYHA) functional classification system.\n * Current uncontrolled hypertension as determined by the investigator that would contraindicate the use of rhEPO.\n * Bazett's correction of QTc interval (QTcB): at Day 1: QTcB >500 milliseconds, or QTcB >530 milliseconds in subjects with bundle branch block. There is no QTc (corrected QT) exclusion for subjects with a predominantly ventricular paced rhythm.\n * Liver Disease: presence of any one of the following liver-related laboratory values or conditions, at screening, is exclusionary: ALT >2x upper limit of normal (ULN); Bilirubin >1.5x ULN; or Current unstable liver or biliary disease per investigator assessment, generally defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis.\n * Evidence of actively bleeding gastric, duodenal or esophageal ulcer disease OR clinically significant gastro intestinal bleeding <= 8 weeks prior to screening through to randomization (Day 1).\n * History of malignancy within 2 years prior to screening through to randomization (Day 1), currently receiving treatment for cancer, or complex kidney cyst (e.g., Bosniak Category IIF, III or IV) >3 centimeters.\n * Use of a strong inhibitor of Cytochrome P4502C8 [CYP2C8] (e.g. gemfibrozil) or a strong inducer of CYP2C8 (e.g. rifampin/rifampicin).\n * History of severe allergic or anaphylactic reactions or hypersensitivity to excipients in the investigational product (daprodustat) or epoetin alfa.\n * Use of another investigational agent within 30 days or within five half-lives of the investigational agent (whichever is longer) or currently participating in a study of an investigational device prior to screening through to randomization (Day 1).\n * Any prior treatment with daprodustat for treatment duration of >30 days.\n * Any other condition, clinical or laboratory abnormality, or examination finding that the investigator considers would put the subject at unacceptable risk, which may affect study compliance (e.g. intolerance to rhEPO) or prevent understanding of the aims or investigational procedures or possible consequences of the study.",{"$nulls":4},"Actual","2018-01-17","Actual","Anticipated","2020-07-07","Anticipated","2018-09-01","2018-01-08","2018-01-08","2018-09-17","Yes","CKD, EPO, rhEPO, Hemodialysis dependent, Daprodustat","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years","99 Years","All",null,"No","Yes\nIPD for this study will be made available via the Clinical Study Data Request site.",{"$nulls":3},"Yes","No",{"$nulls":19},"Mean change in Hemoglobin (Hgb) between Baseline and over Evaluation period [EP] (Weeks 28 to 52)","Blood samples will be collected from subjects for Hgb measurements.","Baseline and up to Week 52","Mean monthly intravenous (IV) iron dose per subject up to Week 52|Number of subjects with adverse events (AEs), serious adverse events (SAEs), adverse event of special interest (AESI) and MACE|Percentage of time Hgb will be in the analysis range (10 to 11.5 grams/deciliter) over EP (Weeks 28 to 52)|Time to stopping study treatment due to meeting rescue criteria|Number of responders in the Hgb analysis range over EP (Weeks 28 to 52)|Change from Baseline in SBP, DBP and mean arterial pressure (MAP) at Week 52 and at the end of study treatment|Number of BP exacerbation events per 100 subject years|Number of subjects with at least one BP exacerbation event during the study|Pre-dose trough concentration (Ctau) of daprodustat|Pre-dose Ctau of metabolites M2|Pre-dose Ctau of metabolites M4|Pre-dose Ctau of metabolites M3|Pre-dose Ctau of metabolites M5|Pre-dose Ctau of metabolites M6|Pre-dose Ctau of metabolites M13|Maximum observed concentration (Cmax) of daprodustat|Cmax of metabolites M2|Cmax of metabolites M3|Cmax of metabolites M4|Cmax of metabolites M5|Cmax of metabolites M6|Cmax of metabolites M13|Change from Baseline in Patient Global Impression of Severity (PGI-S) score|Absolute values over time for composite of hematology parameters as a measure of safety|Changes from baseline over time in composite of hematology parameters as a measure of safety|Absolute values over time for composite of chemistry parameters as a measure of safety|Changes from baseline over time in composite of chemistry parameters as a measure of safety|Absolute values of systolic and diastolic blood pressure as a measure of safety|Change from Baseline in systolic and diastolic blood pressure as a measure of safety|Absolute values for heart rate as a measure of safety|Change from Baseline in Heart rate as a measure of safety","IV iron use for all subjects will be recorded in the electronic case record form (eCRF) and the average monthly IV iron dose up to Week 52 while on treatment will be calculated.|AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is medically significant. Along with AE and SAE the study will also assess AESI and MACE events until follow-up Week 52.|Subjects will be treated to achieve and maintain Hgb between 10 and 11.5 grams/deciliter. The study treatment may be dose-titrated, if needed, during EP to achieve or maintain Hgb level in the target range.|A rescue algorithm is provided to minimize subjects having an inadequate response to the treatment for their anemia for an extended period of time and to enable consistency in the application of rescue therapy across the study. The time to stopping of study treatment due to subjects meeting the rescue criteria will be assessed. The date and time of rescue medication administration as well as the name and dosage regimen of the rescue medication must be recorded.|A responder is defined as a subject with mean Hgb within the Hgb analysis range 10 to 11.5 grams/deciliter during the EP. Subjects will be treated to achieve and maintain Hgb between 10 and 11.5 grams/deciliter. The study treatment may be dose-titrated, if needed, during EP to achieve or maintain Hgb level in the target range.|MAP is an average BP in an individual during a single cardiac cycle. Measurements will be taken both pre-dialysis and post-dialysis. Measurements will be taken with the subject is in a semi-supine or seated position in the dialysis chair after at least a 5-minute rest period, pre- and post-dialysis. Measurement of SBP, DBP and MAP will be performed before collection of blood samples for laboratory testing, where applicable.|The calculation of events per subject-years is the number of incident cases divided by the amount of subjects-time at risk. Number of BP exacerbation events per 100 subject years will be calculated.|Number of subjects with at least 1 BP exacerbation event up to Week 52 will be calculated.|Blood samples (6 in total) will be collected at the Day 1 visit pre-dose and at any one post-Baseline visit between Week 8 and Week 52.|Change from Baseline in global symptom severity will be assessed. Symptom severity will be assessed using the PGI-S. The PGI-S is a 1-item questionnaire designed to assess subjects impression of disease severity of their anemia of CKD.|The following hematology parameters will be measured: Hemoglobin, Hematocrit, RBC count, Mean corpuscular volume (MCV), Mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), Red cell distribution width (RDW), Reticulocyte count, Platelet count, white blood cell (WBC) count, Total neutrophils, Eosinophils, Monocytes, Basophils, and Lymphocytes|The following chemistry parameters will be measured: Potassium, Albumin, Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Calcium, Phosphate, Total and direct/indirect bilirubin, and urea (serum).|Measurements will be taken both pre-dialysis and post-dialysis. Measurements will be taken with the subject is in a semi-supine or seated position in the dialysis chair after at least a 5-minute rest period, pre and post-dialysis. Measurement of SBP and DBP will be performed before collection of blood samples for laboratory testing, where applicable.|Measurements will be taken both pre-dialysis and post-dialysis. Measurements will be taken with the subject is in a semi-supine or seated position in the dialysis chair after at least a 5-minute rest period, pre and post-dialysis. Measurement of heart rate will be performed before collection of blood samples for laboratory testing, where applicable.","Up to Week 52|Weeks 28 to 52|Baseline and Week 52|Pre-dose at any one post-Baseline visit between Week 8 and Week 52|Pre-dose and 0.5, 1, 2, 3 hours|Pre-dose and 0.5, 1, 2, 3 hours post-dose|Baseline and up to Week 52","GSKClinicalSupportHD@gsk.com","US GSK Clinical Trials Call Center","877-379-3718","Heidelberg, Victoria, Australia, 3084|Oshawa, Ontario, Canada, L1G 2B9|Granollers, Barcelona, Spain, 08041|Swansea, United Kingdom, Sa6 6Nl|Mesa, Arizona, United States, 85210|Paramount, California, United States, 90723|Kansas City, Missouri, United States, 64111|Oklahoma City, Oklahoma, United States, 73116","Arizona|California|Missouri|Oklahoma","Australia|Canada|Spain|United Kingdom|United States","Victoria Gsk Investigational Site|Ontario Gsk Investigational Site|Gsk Investigational Site",{"$nulls":3},"GSK Clinical Trials","2018-09-17","2020-05-25T16:36:56.214","2020-05-26T17:10:42.972","NCT03400033"]
["5ecbf428307e3d1b1f8d9cf7","NCT03400033","2018-09-28","GlaxoSmithKline","GSK","Recruiting","Anemia Studies in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat-Three-times Weekly Dosing in Dialysis (ASCEND-TD)","Daprodustat|Epoetin alfa","HIF Inhibitor|ESA Activator","Yes","['Daprodustat']","Yes","['HIF Inhibitor']","Phase 3",2,402,"Anticipated","2018-09-05","2020-07-07",{"$nulls":5},"This Phase 3 study in hemodialysis-dependent subjects with anemia will evaluate the efficacy and safety of daprodustat administered three-times weekly compared to epoetin alfa, the current standard of care. This study includes a 4 week Screening Period, a 52 week Treatment Period and a 4 to 6 week follow-up period. Each subject will remain in the study for up to 62 weeks. Approximately 402 subjects will be randomized to receive either daprodustat three times weekly or epoetin alfa three-times weekly or once weekly, depending on dose level.",null,"A Phase 3 Randomized, Double-blind, Active-controlled, Parallel-group, Multi-center Study in Hemodialysis Participants With Anemia of Chronic Kidney Disease to Evaluate the Efficacy, Safety and Pharmacokinetics of Three-times Weekly Dosing of Daprodustat Compared to Recombinant Human Erythropoietin, Following a Switch From Recombinant Human Erythropoietin or Its Analogs",204837,"Anaemia","Anemia","Hematologic Diseases","Heme & Lymph Diseases","Experimental|Active Comparator","Daprodustat|Epoetin alfa","Subjects randomized to this arm will receive daprodustat tablets titrated doses from 2 to 48 milligrams orally three-times weekly along with saline by IV route for the 52 weeks treatment period.|Subjects randomized to this arm will receive matching placebo tablets to daprodustat orally three-times weekly and Epoetin alfa by IV route for the 52 weeks treatment period.","Drug","Daprodustat tablets|Saline vials or bags|Matching placebo tablets|Epoetin alfa vials","Round, biconvex, white, film-coated tablet in unit dose strengths 2 and 4 milligrams (7 millimeter tablets), 6, 8 and 10 milligrams (9 millimeter tablets) administered by the oral route.|0.9% sodium chloride saline vials or bags administered by the IV route.|Matching placebo to daprodustat tablets supplied as round, biconvex, white, film-coated tablet in unit dose strengths 2 and 4 milligrams (7 millimeter tablets), 6, 8 and 10 milligrams (9 millimeter tablets) administered by the oral route.|Single-dose, preservative-free vials in unit dose strengths of 2000, 3000, 4000 and 10,000 Units/milliliter administered by the IV route.",null,"Daprodustat|Epoetin alfa","\n\n * Subject must be 18 to 99 years of age inclusive, at the time of signing the informed consent.\n * Use of any approved rhEPO or analog for at least 8 weeks prior to the screening visit and continuing during the screening period until randomization (Day 1).\n * Hgb concentration (measured by HemoCue) within the following range: Week -4: Hgb 8 to 11.5 grams/deciliter (5 to 7.1 millimoles/liter). If Hgb is 11.6 to 11.9 grams/deciliter (7.2 to 7.4 millimoles/liter), up to two retests are allowed; the retest value must be between 8 to 11.5 grams/deciliter (5 to 7.1 millimoles/liter). Day 1: Hgb 8 to 11 grams/deciliter (5 to 6.8 millimoles/liter) and receiving at least the minimum rhEPO or analog dose 3. Hgb>11 to 11.5 grams/deciliter (6.8 to 7.1 millimoles/liter) and receiving greater than the minimum rhEPO or analog dose 3.\n * On hemodialysis (including hemofiltration or hemodiafiltration) >90 days prior to screening and continuing during the screening period.\n * On hemodialysis (in-center) >=3 times per week.\n * Male and female subjects are eligible. A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: Not a woman of childbearing potential (WOCBP), or A WOCBP who agrees to follow the contraceptive guidance from at least 28 days prior to first dose of study treatment and for at least 28 days after the last dose of study treatment.\n * Capable of giving signed informed consent.\n * In France, a subject will be eligible for inclusion in this study if he or she is either affiliated to or beneficiary of a social security category.\n\n","\n\n * Planned living-related or living-unrelated kidney transplant within 52 weeks after randomization (Day 1).\n * Ferritin: <=100 nanograms/milliliter (<=100 micrograms/liter), at screening.\n * Transferrin saturation (TSAT): <=20 percent, at screening. If TSAT is 18 to 20 percent, then a retest using a new blood sample can be obtained within 7 days of the final laboratory report; the final retest value must be >20 percent to confirm eligibility.\n * Aplasias: History of bone marrow aplasia or pure red cell aplasia.\n * Conditions, other than anemia of CKD, which can affect erythropoiesis.\n * Myocardial infarction (MI) or acute coronary syndrome within 8 weeks prior to screening through to randomization (Day 1).\n * Stroke or transient ischemic attack within 8 weeks prior to screening through to randomization (Day 1).\n * Heart failure (HF): Chronic Class IV HF, as defined by the New York Heart Association (NYHA) functional classification system.\n * Current uncontrolled hypertension as determined by the investigator that would contraindicate the use of rhEPO.\n * Bazett's correction of QTc interval (QTcB): at Day 1: QTcB >500 milliseconds, or QTcB >530 milliseconds in subjects with bundle branch block. There is no QTc (corrected QT) exclusion for subjects with a predominantly ventricular paced rhythm.\n * Liver Disease: presence of any one of the following liver-related laboratory values or conditions, at screening, is exclusionary: ALT >2x upper limit of normal (ULN); Bilirubin >1.5x ULN; or Current unstable liver or biliary disease per investigator assessment, generally defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis.\n * Evidence of actively bleeding gastric, duodenal or esophageal ulcer disease OR clinically significant gastro intestinal bleeding <= 8 weeks prior to screening through to randomization (Day 1).\n * History of malignancy within 2 years prior to screening through to randomization (Day 1), currently receiving treatment for cancer, or complex kidney cyst (e.g., Bosniak Category IIF, III or IV) >3 centimeters.\n * Use of a strong inhibitor of Cytochrome P4502C8 [CYP2C8] (e.g. gemfibrozil) or a strong inducer of CYP2C8 (e.g. rifampin/rifampicin).\n * History of severe allergic or anaphylactic reactions or hypersensitivity to excipients in the investigational product (daprodustat) or epoetin alfa.\n * Use of another investigational agent within 30 days or within five half-lives of the investigational agent (whichever is longer) or currently participating in a study of an investigational device prior to screening through to randomization (Day 1).\n * Any prior treatment with daprodustat for treatment duration of >30 days.\n * Any other condition, clinical or laboratory abnormality, or examination finding that the investigator considers would put the subject at unacceptable risk, which may affect study compliance (e.g. intolerance to rhEPO) or prevent understanding of the aims or investigational procedures or possible consequences of the study.",{"$nulls":4},"Actual","2018-01-17","Actual","Anticipated","2020-07-07","Anticipated","2018-09-01","2018-01-08","2018-01-08","2018-09-27","Yes","CKD, EPO, rhEPO, Hemodialysis dependent, Daprodustat","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years","99 Years","All",null,"No","Yes\nIPD for this study will be made available via the Clinical Study Data Request site.",{"$nulls":3},"Yes","No",{"$nulls":19},"Mean change in Hemoglobin (Hgb) between Baseline and over Evaluation period [EP] (Weeks 28 to 52)","Blood samples will be collected from subjects for Hgb measurements.","Baseline and up to Week 52","Mean monthly intravenous (IV) iron dose per subject up to Week 52|Number of subjects with adverse events (AEs), serious adverse events (SAEs), adverse event of special interest (AESI) and MACE|Percentage of time Hgb will be in the analysis range (10 to 11.5 grams/deciliter) over EP (Weeks 28 to 52)|Time to stopping study treatment due to meeting rescue criteria|Number of responders in the Hgb analysis range over EP (Weeks 28 to 52)|Change from Baseline in SBP, DBP and mean arterial pressure (MAP) at Week 52 and at the end of study treatment|Number of BP exacerbation events per 100 subject years|Number of subjects with at least one BP exacerbation event during the study|Pre-dose trough concentration (Ctau) of daprodustat|Pre-dose Ctau of metabolites M2|Pre-dose Ctau of metabolites M4|Pre-dose Ctau of metabolites M3|Pre-dose Ctau of metabolites M5|Pre-dose Ctau of metabolites M6|Pre-dose Ctau of metabolites M13|Maximum observed concentration (Cmax) of daprodustat|Cmax of metabolites M2|Cmax of metabolites M3|Cmax of metabolites M4|Cmax of metabolites M5|Cmax of metabolites M6|Cmax of metabolites M13|Change from Baseline in Patient Global Impression of Severity (PGI-S) score|Absolute values over time for composite of hematology parameters as a measure of safety|Changes from baseline over time in composite of hematology parameters as a measure of safety|Absolute values over time for composite of chemistry parameters as a measure of safety|Changes from baseline over time in composite of chemistry parameters as a measure of safety|Absolute values of systolic and diastolic blood pressure as a measure of safety|Change from Baseline in systolic and diastolic blood pressure as a measure of safety|Absolute values for heart rate as a measure of safety|Change from Baseline in Heart rate as a measure of safety","IV iron use for all subjects will be recorded in the electronic case record form (eCRF) and the average monthly IV iron dose up to Week 52 while on treatment will be calculated.|AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is medically significant. Along with AE and SAE the study will also assess AESI and MACE events until follow-up Week 52.|Subjects will be treated to achieve and maintain Hgb between 10 and 11.5 grams/deciliter. The study treatment may be dose-titrated, if needed, during EP to achieve or maintain Hgb level in the target range.|A rescue algorithm is provided to minimize subjects having an inadequate response to the treatment for their anemia for an extended period of time and to enable consistency in the application of rescue therapy across the study. The time to stopping of study treatment due to subjects meeting the rescue criteria will be assessed. The date and time of rescue medication administration as well as the name and dosage regimen of the rescue medication must be recorded.|A responder is defined as a subject with mean Hgb within the Hgb analysis range 10 to 11.5 grams/deciliter during the EP. Subjects will be treated to achieve and maintain Hgb between 10 and 11.5 grams/deciliter. The study treatment may be dose-titrated, if needed, during EP to achieve or maintain Hgb level in the target range.|MAP is an average BP in an individual during a single cardiac cycle. Measurements will be taken both pre-dialysis and post-dialysis. Measurements will be taken with the subject is in a semi-supine or seated position in the dialysis chair after at least a 5-minute rest period, pre- and post-dialysis. Measurement of SBP, DBP and MAP will be performed before collection of blood samples for laboratory testing, where applicable.|The calculation of events per subject-years is the number of incident cases divided by the amount of subjects-time at risk. Number of BP exacerbation events per 100 subject years will be calculated.|Number of subjects with at least 1 BP exacerbation event up to Week 52 will be calculated.|Blood samples (6 in total) will be collected at the Day 1 visit pre-dose and at any one post-Baseline visit between Week 8 and Week 52.|Change from Baseline in global symptom severity will be assessed. Symptom severity will be assessed using the PGI-S. The PGI-S is a 1-item questionnaire designed to assess subjects impression of disease severity of their anemia of CKD.|The following hematology parameters will be measured: Hemoglobin, Hematocrit, RBC count, Mean corpuscular volume (MCV), Mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), Red cell distribution width (RDW), Reticulocyte count, Platelet count, white blood cell (WBC) count, Total neutrophils, Eosinophils, Monocytes, Basophils, and Lymphocytes|The following chemistry parameters will be measured: Potassium, Albumin, Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Calcium, Phosphate, Total and direct/indirect bilirubin, and urea (serum).|Measurements will be taken both pre-dialysis and post-dialysis. Measurements will be taken with the subject is in a semi-supine or seated position in the dialysis chair after at least a 5-minute rest period, pre and post-dialysis. Measurement of SBP and DBP will be performed before collection of blood samples for laboratory testing, where applicable.|Measurements will be taken both pre-dialysis and post-dialysis. Measurements will be taken with the subject is in a semi-supine or seated position in the dialysis chair after at least a 5-minute rest period, pre and post-dialysis. Measurement of heart rate will be performed before collection of blood samples for laboratory testing, where applicable.","Up to Week 52|Weeks 28 to 52|Baseline and Week 52|Pre-dose at any one post-Baseline visit between Week 8 and Week 52|Pre-dose and 0.5, 1, 2, 3 hours|Pre-dose and 0.5, 1, 2, 3 hours post-dose|Baseline and up to Week 52","GSKClinicalSupportHD@gsk.com","US GSK Clinical Trials Call Center","877-379-3718","Heidelberg, Victoria, Australia, 3084|Oshawa, Ontario, Canada, L1G 2B9|Almeria, Spain, 04009|Swansea, United Kingdom, Sa6 6Nl|Mesa, Arizona, United States, 85210|Fresno, California, United States, 93720|Hollywood, Florida, United States, 33024|Kansas City, Missouri, United States, 64111|Oklahoma City, Oklahoma, United States, 73116","Arizona|California|Florida|Missouri|Oklahoma","Australia|Canada|Spain|United Kingdom|United States","Victoria Gsk Investigational Site|Ontario Gsk Investigational Site|Gsk Investigational Site",{"$nulls":3},"GSK Clinical Trials","2018-09-27","2020-05-25T16:36:56.445","2020-05-26T17:10:42.972","NCT03400033"]
["5ecbf42811702c1b1b916a77","NCT03400033","2018-10-09","GlaxoSmithKline","GSK","Recruiting","Anemia Studies in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat-Three-times Weekly Dosing in Dialysis (ASCEND-TD)","Daprodustat|Epoetin alfa","HIF Inhibitor|ESA Activator","Yes","['Daprodustat']","Yes","['HIF Inhibitor']","Phase 3",2,402,"Anticipated","2018-09-05","2020-07-07",{"$nulls":5},"This Phase 3 study in hemodialysis-dependent subjects with anemia will evaluate the efficacy and safety of daprodustat administered three-times weekly compared to epoetin alfa, the current standard of care. This study includes a 4 week Screening Period, a 52 week Treatment Period and a 4 to 6 week follow-up period. Each subject will remain in the study for up to 62 weeks. Approximately 402 subjects will be randomized to receive either daprodustat three times weekly or epoetin alfa three-times weekly or once weekly, depending on dose level.",null,"A Phase 3 Randomized, Double-blind, Active-controlled, Parallel-group, Multi-center Study in Hemodialysis Participants With Anemia of Chronic Kidney Disease to Evaluate the Efficacy, Safety and Pharmacokinetics of Three-times Weekly Dosing of Daprodustat Compared to Recombinant Human Erythropoietin, Following a Switch From Recombinant Human Erythropoietin or Its Analogs",204837,"Anaemia","Anemia","Hematologic Diseases","Heme & Lymph Diseases","Experimental|Active Comparator","Daprodustat|Epoetin alfa","Subjects randomized to this arm will receive daprodustat tablets titrated doses from 2 to 48 milligrams orally three-times weekly along with saline by IV route for the 52 weeks treatment period.|Subjects randomized to this arm will receive matching placebo tablets to daprodustat orally three-times weekly and Epoetin alfa by IV route for the 52 weeks treatment period.","Drug","Daprodustat tablets|Saline vials or bags|Matching placebo tablets|Epoetin alfa vials","Round, biconvex, white, film-coated tablet in unit dose strengths 2 and 4 milligrams (7 millimeter tablets), 6, 8 and 10 milligrams (9 millimeter tablets) administered by the oral route.|0.9% sodium chloride saline vials or bags administered by the IV route.|Matching placebo to daprodustat tablets supplied as round, biconvex, white, film-coated tablet in unit dose strengths 2 and 4 milligrams (7 millimeter tablets), 6, 8 and 10 milligrams (9 millimeter tablets) administered by the oral route.|Single-dose, preservative-free vials in unit dose strengths of 2000, 3000, 4000 and 10,000 Units/milliliter administered by the IV route.",null,"Daprodustat|Epoetin alfa","\n\n * Subject must be 18 to 99 years of age inclusive, at the time of signing the informed consent.\n * Use of any approved rhEPO or analog for at least 8 weeks prior to the screening visit and continuing during the screening period until randomization (Day 1).\n * Hgb concentration (measured by HemoCue) within the following range: Week -4: Hgb 8 to 11.5 grams/deciliter (5 to 7.1 millimoles/liter). If Hgb is 11.6 to 11.9 grams/deciliter (7.2 to 7.4 millimoles/liter), up to two retests are allowed; the retest value must be between 8 to 11.5 grams/deciliter (5 to 7.1 millimoles/liter). Day 1: Hgb 8 to 11 grams/deciliter (5 to 6.8 millimoles/liter) and receiving at least the minimum rhEPO or analog dose 3. Hgb>11 to 11.5 grams/deciliter (6.8 to 7.1 millimoles/liter) and receiving greater than the minimum rhEPO or analog dose 3.\n * On hemodialysis (including hemofiltration or hemodiafiltration) >90 days prior to screening and continuing during the screening period.\n * On hemodialysis (in-center) >=3 times per week.\n * Male and female subjects are eligible. A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: Not a woman of childbearing potential (WOCBP), or A WOCBP who agrees to follow the contraceptive guidance from at least 28 days prior to first dose of study treatment and for at least 28 days after the last dose of study treatment.\n * Capable of giving signed informed consent.\n * In France, a subject will be eligible for inclusion in this study if he or she is either affiliated to or beneficiary of a social security category.\n\n","\n\n * Planned living-related or living-unrelated kidney transplant within 52 weeks after randomization (Day 1).\n * Ferritin: <=100 nanograms/milliliter (<=100 micrograms/liter), at screening.\n * Transferrin saturation (TSAT): <=20 percent, at screening. If TSAT is 18 to 20 percent, then a retest using a new blood sample can be obtained within 7 days of the final laboratory report; the final retest value must be >20 percent to confirm eligibility.\n * Aplasias: History of bone marrow aplasia or pure red cell aplasia.\n * Conditions, other than anemia of CKD, which can affect erythropoiesis.\n * Myocardial infarction (MI) or acute coronary syndrome within 8 weeks prior to screening through to randomization (Day 1).\n * Stroke or transient ischemic attack within 8 weeks prior to screening through to randomization (Day 1).\n * Heart failure (HF): Chronic Class IV HF, as defined by the New York Heart Association (NYHA) functional classification system.\n * Current uncontrolled hypertension as determined by the investigator that would contraindicate the use of rhEPO.\n * Bazett's correction of QTc interval (QTcB): at Day 1: QTcB >500 milliseconds, or QTcB >530 milliseconds in subjects with bundle branch block. There is no QTc (corrected QT) exclusion for subjects with a predominantly ventricular paced rhythm.\n * Liver Disease: presence of any one of the following liver-related laboratory values or conditions, at screening, is exclusionary: ALT >2x upper limit of normal (ULN); Bilirubin >1.5x ULN; or Current unstable liver or biliary disease per investigator assessment, generally defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis.\n * Evidence of actively bleeding gastric, duodenal or esophageal ulcer disease OR clinically significant gastro intestinal bleeding <= 8 weeks prior to screening through to randomization (Day 1).\n * History of malignancy within 2 years prior to screening through to randomization (Day 1), currently receiving treatment for cancer, or complex kidney cyst (e.g., Bosniak Category IIF, III or IV) >3 centimeters.\n * Use of a strong inhibitor of Cytochrome P4502C8 [CYP2C8] (e.g. gemfibrozil) or a strong inducer of CYP2C8 (e.g. rifampin/rifampicin).\n * History of severe allergic or anaphylactic reactions or hypersensitivity to excipients in the investigational product (daprodustat) or epoetin alfa.\n * Use of another investigational agent within 30 days or within five half-lives of the investigational agent (whichever is longer) or currently participating in a study of an investigational device prior to screening through to randomization (Day 1).\n * Any prior treatment with daprodustat for treatment duration of >30 days.\n * Any other condition, clinical or laboratory abnormality, or examination finding that the investigator considers would put the subject at unacceptable risk, which may affect study compliance (e.g. intolerance to rhEPO) or prevent understanding of the aims or investigational procedures or possible consequences of the study.",{"$nulls":4},"Actual","2018-01-17","Actual","Anticipated","2020-07-07","Anticipated","2018-10-01","2018-01-08","2018-01-08","2018-10-08","Yes","CKD, EPO, rhEPO, Hemodialysis dependent, Daprodustat","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years","99 Years","All",null,"No","Yes\nIPD for this study will be made available via the Clinical Study Data Request site.",{"$nulls":3},"Yes","No",{"$nulls":19},"Mean change in Hemoglobin (Hgb) between Baseline and over Evaluation period [EP] (Weeks 28 to 52)","Blood samples will be collected from subjects for Hgb measurements.","Baseline and up to Week 52","Mean monthly intravenous (IV) iron dose per subject up to Week 52|Number of subjects with adverse events (AEs), serious adverse events (SAEs), adverse event of special interest (AESI) and MACE|Percentage of time Hgb will be in the analysis range (10 to 11.5 grams/deciliter) over EP (Weeks 28 to 52)|Time to stopping study treatment due to meeting rescue criteria|Number of responders in the Hgb analysis range over EP (Weeks 28 to 52)|Change from Baseline in SBP, DBP and mean arterial pressure (MAP) at Week 52 and at the end of study treatment|Number of BP exacerbation events per 100 subject years|Number of subjects with at least one BP exacerbation event during the study|Pre-dose trough concentration (Ctau) of daprodustat|Pre-dose Ctau of metabolites M2|Pre-dose Ctau of metabolites M4|Pre-dose Ctau of metabolites M3|Pre-dose Ctau of metabolites M5|Pre-dose Ctau of metabolites M6|Pre-dose Ctau of metabolites M13|Maximum observed concentration (Cmax) of daprodustat|Cmax of metabolites M2|Cmax of metabolites M3|Cmax of metabolites M4|Cmax of metabolites M5|Cmax of metabolites M6|Cmax of metabolites M13|Change from Baseline in Patient Global Impression of Severity (PGI-S) score|Absolute values over time for composite of hematology parameters as a measure of safety|Changes from baseline over time in composite of hematology parameters as a measure of safety|Absolute values over time for composite of chemistry parameters as a measure of safety|Changes from baseline over time in composite of chemistry parameters as a measure of safety|Absolute values of systolic and diastolic blood pressure as a measure of safety|Change from Baseline in systolic and diastolic blood pressure as a measure of safety|Absolute values for heart rate as a measure of safety|Change from Baseline in Heart rate as a measure of safety","IV iron use for all subjects will be recorded in the electronic case record form (eCRF) and the average monthly IV iron dose up to Week 52 while on treatment will be calculated.|AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is medically significant. Along with AE and SAE the study will also assess AESI and MACE events until follow-up Week 52.|Subjects will be treated to achieve and maintain Hgb between 10 and 11.5 grams/deciliter. The study treatment may be dose-titrated, if needed, during EP to achieve or maintain Hgb level in the target range.|A rescue algorithm is provided to minimize subjects having an inadequate response to the treatment for their anemia for an extended period of time and to enable consistency in the application of rescue therapy across the study. The time to stopping of study treatment due to subjects meeting the rescue criteria will be assessed. The date and time of rescue medication administration as well as the name and dosage regimen of the rescue medication must be recorded.|A responder is defined as a subject with mean Hgb within the Hgb analysis range 10 to 11.5 grams/deciliter during the EP. Subjects will be treated to achieve and maintain Hgb between 10 and 11.5 grams/deciliter. The study treatment may be dose-titrated, if needed, during EP to achieve or maintain Hgb level in the target range.|MAP is an average BP in an individual during a single cardiac cycle. Measurements will be taken both pre-dialysis and post-dialysis. Measurements will be taken with the subject is in a semi-supine or seated position in the dialysis chair after at least a 5-minute rest period, pre- and post-dialysis. Measurement of SBP, DBP and MAP will be performed before collection of blood samples for laboratory testing, where applicable.|The calculation of events per subject-years is the number of incident cases divided by the amount of subjects-time at risk. Number of BP exacerbation events per 100 subject years will be calculated.|Number of subjects with at least 1 BP exacerbation event up to Week 52 will be calculated.|Blood samples (6 in total) will be collected at the Day 1 visit pre-dose and at any one post-Baseline visit between Week 8 and Week 52.|Change from Baseline in global symptom severity will be assessed. Symptom severity will be assessed using the PGI-S. The PGI-S is a 1-item questionnaire designed to assess subjects impression of disease severity of their anemia of CKD.|The following hematology parameters will be measured: Hemoglobin, Hematocrit, RBC count, Mean corpuscular volume (MCV), Mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), Red cell distribution width (RDW), Reticulocyte count, Platelet count, white blood cell (WBC) count, Total neutrophils, Eosinophils, Monocytes, Basophils, and Lymphocytes|The following chemistry parameters will be measured: Potassium, Albumin, Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Calcium, Phosphate, Total and direct/indirect bilirubin, and urea (serum).|Measurements will be taken both pre-dialysis and post-dialysis. Measurements will be taken with the subject is in a semi-supine or seated position in the dialysis chair after at least a 5-minute rest period, pre and post-dialysis. Measurement of SBP and DBP will be performed before collection of blood samples for laboratory testing, where applicable.|Measurements will be taken both pre-dialysis and post-dialysis. Measurements will be taken with the subject is in a semi-supine or seated position in the dialysis chair after at least a 5-minute rest period, pre and post-dialysis. Measurement of heart rate will be performed before collection of blood samples for laboratory testing, where applicable.","Up to Week 52|Weeks 28 to 52|Baseline and Week 52|Pre-dose at any one post-Baseline visit between Week 8 and Week 52|Pre-dose and 0.5, 1, 2, 3 hours|Pre-dose and 0.5, 1, 2, 3 hours post-dose|Baseline and up to Week 52","GSKClinicalSupportHD@gsk.com","US GSK Clinical Trials Call Center","877-379-3718","Heidelberg, Victoria, Australia, 3084|Oshawa, Ontario, Canada, L1G 2B9|Epagny Metz-Tessy, France, 74370|Lodz, Poland, 92-213|Almeria, Spain, 04009|Swansea, United Kingdom, Sa6 6Nl|Mesa, Arizona, United States, 85210|Fresno, California, United States, 93720|Middlebury, Connecticut, United States, 06762|Hollywood, Florida, United States, 33024|Kansas City, Missouri, United States, 64111|Oklahoma City, Oklahoma, United States, 73116","Arizona|California|Connecticut|Florida|Missouri|Oklahoma","Australia|Canada|France|Poland|Spain|United Kingdom|United States","Victoria Gsk Investigational Site|Ontario Gsk Investigational Site|Gsk Investigational Site",{"$nulls":3},"GSK Clinical Trials","2018-10-08","2020-05-25T16:36:56.693","2020-05-26T17:10:42.972","NCT03400033"]
["5ecbf429feab101b15530898","NCT03400033","2019-06-19","GlaxoSmithKline","GSK","Active, not recruiting","Anemia Studies in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat-Three-times Weekly Dosing in Dialysis (ASCEND-TD)","Daprodustat|Epoetin alfa","HIF Inhibitor|ESA Activator","Yes","['Daprodustat']","Yes","['HIF Inhibitor']","Phase 3",2,402,"Anticipated","2018-09-05","2020-07-08",{"$nulls":5},"This Phase 3 study in hemodialysis-dependent subjects with anemia will evaluate the efficacy and safety of daprodustat administered three-times weekly compared to epoetin alfa, the current standard of care. This study includes a 4 week Screening Period, a 52 week Treatment Period and a 4 to 6 week follow-up period. Each subject will remain in the study for up to 62 weeks. Approximately 402 subjects will be randomized to receive either daprodustat three times weekly or epoetin alfa three-times weekly or once weekly, depending on dose level.",null,"A Phase 3 Randomized, Double-blind, Active-controlled, Parallel-group, Multi-center Study in Hemodialysis Participants With Anemia of Chronic Kidney Disease to Evaluate the Efficacy, Safety and Pharmacokinetics of Three-times Weekly Dosing of Daprodustat Compared to Recombinant Human Erythropoietin, Following a Switch From Recombinant Human Erythropoietin or Its Analogs",204837,"Anaemia","Anemia","Hematologic Diseases","Heme & Lymph Diseases","Experimental|Active Comparator","Daprodustat|Epoetin alfa","Subjects randomized to this arm will receive daprodustat tablets titrated doses from 2 to 48 milligrams orally three-times weekly along with saline by IV route for the 52 weeks treatment period.|Subjects randomized to this arm will receive matching placebo tablets to daprodustat orally three-times weekly and Epoetin alfa by IV route for the 52 weeks treatment period.","Drug","Daprodustat tablets|Saline vials or bags|Matching placebo tablets|Epoetin alfa vials","Round, biconvex, white, film-coated tablet in unit dose strengths 2 and 4 milligrams (7 millimeter tablets), 6, 8 and 10 milligrams (9 millimeter tablets) administered by the oral route.|0.9% sodium chloride saline vials or bags administered by the IV route.|Matching placebo to daprodustat tablets supplied as round, biconvex, white, film-coated tablet in unit dose strengths 2 and 4 milligrams (7 millimeter tablets), 6, 8 and 10 milligrams (9 millimeter tablets) administered by the oral route.|Single-dose, preservative-free vials in unit dose strengths of 2000, 3000, 4000 and 10,000 Units/milliliter administered by the IV route.",null,"Daprodustat|Epoetin alfa","\n\n * Subject must be 18 to 99 years of age inclusive, at the time of signing the informed consent.\n * Use of any approved rhEPO or analog for at least 8 weeks prior to the screening visit and continuing during the screening period until randomization (Day 1).\n * Hgb concentration (measured by HemoCue) within the following range: Week -4: Hgb 8 to 11.5 grams/deciliter (5 to 7.1 millimoles/liter). If Hgb is 11.6 to 11.9 grams/deciliter (7.2 to 7.4 millimoles/liter), up to two retests are allowed; the retest value must be between 8 to 11.5 grams/deciliter (5 to 7.1 millimoles/liter). Day 1: Hgb 8 to 11 grams/deciliter (5 to 6.8 millimoles/liter) and receiving at least the minimum rhEPO or analog dose 3. Hgb>11 to 11.5 grams/deciliter (6.8 to 7.1 millimoles/liter) and receiving greater than the minimum rhEPO or analog dose 3.\n * On hemodialysis (including hemofiltration or hemodiafiltration) >90 days prior to screening and continuing during the screening period.\n * On hemodialysis (in-center) >=3 times per week.\n * Male and female subjects are eligible. A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: Not a woman of childbearing potential (WOCBP), or A WOCBP who agrees to follow the contraceptive guidance from at least 28 days prior to first dose of study treatment and for at least 28 days after the last dose of study treatment.\n * Capable of giving signed informed consent.\n * In France, a subject will be eligible for inclusion in this study if he or she is either affiliated to or beneficiary of a social security category.\n\n","\n\n * Planned living-related or living-unrelated kidney transplant within 52 weeks after randomization (Day 1).\n * Ferritin: <=100 nanograms/milliliter (<=100 micrograms/liter), at screening.\n * Transferrin saturation (TSAT): <=20 percent, at screening. If TSAT is 18 to 20 percent, then a retest using a new blood sample can be obtained within 7 days of the final laboratory report; the final retest value must be >20 percent to confirm eligibility.\n * Aplasias: History of bone marrow aplasia or pure red cell aplasia.\n * Conditions, other than anemia of CKD, which can affect erythropoiesis.\n * Myocardial infarction (MI) or acute coronary syndrome within 8 weeks prior to screening through to randomization (Day 1).\n * Stroke or transient ischemic attack within 8 weeks prior to screening through to randomization (Day 1).\n * Heart failure (HF): Chronic Class IV HF, as defined by the New York Heart Association (NYHA) functional classification system.\n * Current uncontrolled hypertension as determined by the investigator that would contraindicate the use of rhEPO.\n * Bazett's correction of QTc interval (QTcB): at Day 1: QTcB >500 milliseconds, or QTcB >530 milliseconds in subjects with bundle branch block. There is no QTc (corrected QT) exclusion for subjects with a predominantly ventricular paced rhythm.\n * Liver Disease: presence of any one of the following liver-related laboratory values or conditions, at screening, is exclusionary: ALT >2x upper limit of normal (ULN); Bilirubin >1.5x ULN; or Current unstable liver or biliary disease per investigator assessment, generally defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis.\n * Evidence of actively bleeding gastric, duodenal or esophageal ulcer disease OR clinically significant gastro intestinal bleeding <= 8 weeks prior to screening through to randomization (Day 1).\n * History of malignancy within 2 years prior to screening through to randomization (Day 1), currently receiving treatment for cancer, or complex kidney cyst (e.g., Bosniak Category IIF, III or IV) >3 centimeters.\n * Use of a strong inhibitor of Cytochrome P4502C8 [CYP2C8] (e.g. gemfibrozil) or a strong inducer of CYP2C8 (e.g. rifampin/rifampicin).\n * History of severe allergic or anaphylactic reactions or hypersensitivity to excipients in the investigational product (daprodustat) or epoetin alfa.\n * Use of another investigational agent within 30 days or within five half-lives of the investigational agent (whichever is longer) or currently participating in a study of an investigational device prior to screening through to randomization (Day 1).\n * Any prior treatment with daprodustat for treatment duration of >30 days.\n * Any other condition, clinical or laboratory abnormality, or examination finding that the investigator considers would put the subject at unacceptable risk, which may affect study compliance (e.g. intolerance to rhEPO) or prevent understanding of the aims or investigational procedures or possible consequences of the study.",{"$nulls":4},"Actual","2018-01-17","Actual","Anticipated","2020-07-08","Anticipated","2019-06-01","2018-01-08","2018-01-08","2019-06-18","Yes","CKD, EPO, rhEPO, Hemodialysis dependent, Daprodustat","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years","99 Years","All",null,"No","Yes\nIPD for this study will be made available via the Clinical Study Data Request site.",{"$nulls":3},"Yes","No",{"$nulls":17},"2017-004372-56","EudraCT Number","Mean change in Hemoglobin (Hgb) between Baseline and over Evaluation period [EP] (Weeks 28 to 52)","Blood samples will be collected from subjects for Hgb measurements.","Baseline and up to Week 52","Mean monthly intravenous (IV) iron dose per subject up to Week 52|Number of subjects with adverse events (AEs), serious adverse events (SAEs), adverse event of special interest (AESI) and MACE|Percentage of time Hgb will be in the analysis range (10 to 11.5 grams/deciliter) over EP (Weeks 28 to 52)|Time to stopping study treatment due to meeting rescue criteria|Number of responders in the Hgb analysis range over EP (Weeks 28 to 52)|Change from Baseline in SBP, DBP and mean arterial pressure (MAP) at Week 52 and at the end of study treatment|Number of BP exacerbation events per 100 subject years|Number of subjects with at least one BP exacerbation event during the study|Pre-dose trough concentration (Ctau) of daprodustat|Pre-dose Ctau of metabolites M2|Pre-dose Ctau of metabolites M4|Pre-dose Ctau of metabolites M3|Pre-dose Ctau of metabolites M5|Pre-dose Ctau of metabolites M6|Pre-dose Ctau of metabolites M13|Maximum observed concentration (Cmax) of daprodustat|Cmax of metabolites M2|Cmax of metabolites M3|Cmax of metabolites M4|Cmax of metabolites M5|Cmax of metabolites M6|Cmax of metabolites M13|Change from Baseline in Patient Global Impression of Severity (PGI-S) score|Absolute values over time for composite of hematology parameters as a measure of safety|Changes from baseline over time in composite of hematology parameters as a measure of safety|Absolute values over time for composite of chemistry parameters as a measure of safety|Changes from baseline over time in composite of chemistry parameters as a measure of safety|Absolute values of systolic and diastolic blood pressure as a measure of safety|Change from Baseline in systolic and diastolic blood pressure as a measure of safety|Absolute values for heart rate as a measure of safety|Change from Baseline in Heart rate as a measure of safety","IV iron use for all subjects will be recorded in the electronic case record form (eCRF) and the average monthly IV iron dose up to Week 52 while on treatment will be calculated.|AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is medically significant. Along with AE and SAE the study will also assess AESI and MACE events until follow-up Week 52.|Subjects will be treated to achieve and maintain Hgb between 10 and 11.5 grams/deciliter. The study treatment may be dose-titrated, if needed, during EP to achieve or maintain Hgb level in the target range.|A rescue algorithm is provided to minimize subjects having an inadequate response to the treatment for their anemia for an extended period of time and to enable consistency in the application of rescue therapy across the study. The time to stopping of study treatment due to subjects meeting the rescue criteria will be assessed. The date and time of rescue medication administration as well as the name and dosage regimen of the rescue medication must be recorded.|A responder is defined as a subject with mean Hgb within the Hgb analysis range 10 to 11.5 grams/deciliter during the EP. Subjects will be treated to achieve and maintain Hgb between 10 and 11.5 grams/deciliter. The study treatment may be dose-titrated, if needed, during EP to achieve or maintain Hgb level in the target range.|MAP is an average BP in an individual during a single cardiac cycle. Measurements will be taken both pre-dialysis and post-dialysis. Measurements will be taken with the subject is in a semi-supine or seated position in the dialysis chair after at least a 5-minute rest period, pre- and post-dialysis. Measurement of SBP, DBP and MAP will be performed before collection of blood samples for laboratory testing, where applicable.|The calculation of events per subject-years is the number of incident cases divided by the amount of subjects-time at risk. Number of BP exacerbation events per 100 subject years will be calculated.|Number of subjects with at least 1 BP exacerbation event up to Week 52 will be calculated.|Blood samples (6 in total) will be collected at the Day 1 visit pre-dose and at any one post-Baseline visit between Week 8 and Week 52.|Change from Baseline in global symptom severity will be assessed. Symptom severity will be assessed using the PGI-S. The PGI-S is a 1-item questionnaire designed to assess subjects impression of disease severity of their anemia of CKD.|The following hematology parameters will be measured: Hemoglobin, Hematocrit, RBC count, Mean corpuscular volume (MCV), Mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), Red cell distribution width (RDW), Reticulocyte count, Platelet count, white blood cell (WBC) count, Total neutrophils, Eosinophils, Monocytes, Basophils, and Lymphocytes|The following chemistry parameters will be measured: Potassium, Albumin, Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Calcium, Phosphate, Total and direct/indirect bilirubin, and urea (serum).|Measurements will be taken both pre-dialysis and post-dialysis. Measurements will be taken with the subject is in a semi-supine or seated position in the dialysis chair after at least a 5-minute rest period, pre and post-dialysis. Measurement of SBP and DBP will be performed before collection of blood samples for laboratory testing, where applicable.|Measurements will be taken both pre-dialysis and post-dialysis. Measurements will be taken with the subject is in a semi-supine or seated position in the dialysis chair after at least a 5-minute rest period, pre and post-dialysis. Measurement of heart rate will be performed before collection of blood samples for laboratory testing, where applicable.","Up to Week 52|Weeks 28 to 52|Baseline and Week 52|Pre-dose at any one post-Baseline visit between Week 8 and Week 52|Pre-dose and 0.5, 1, 2, 3 hours|Pre-dose and 0.5, 1, 2, 3 hours post-dose|Baseline and up to Week 52",{"$nulls":3},"Mar Del Plata, Buenos Aires, Argentina, 7600 Gsk Investigational SitePergamino, Buenos Aires, Argentina, B2700Cpm Gsk Investigational SiteSarandi, Buenos Aires, Argentina, B1872Eeb|Rosario, Santa Fe, Argentina, 2000|Heidelberg, Victoria, Australia, 3084 Gsk Investigational SiteParkville, Victoria, Australia, 3050|Belo Horizonte, Minas Gerais, Brazil, 30150-221 Gsk Investigational SiteFeira De Santana, Brazil, 44001-465 Gsk Investigational SiteSÃ£o Paulo, Brazil, 04039-000|Curitiba, ParanÃ¡, Brazil, 80440-020|Passo Fundo, Rio Grande Do Sul, Brazil, 99010-080 Gsk Investigational SitePorto Alegre, Rio Grande Do Sul, Brazil, 90610-000|Sao Jose Do Rio Preto, SÃ£o Paulo, Brazil, 15090-000|Oshawa, Ontario, Canada, L1G 2B9|Bayonne, France, 64109 Gsk Investigational SiteEpagny Metz-Tessy, France, 74370 Gsk Investigational SiteLe Mans, France, 72037 Gsk Investigational SiteNice Cedex 1, France, 06001 Gsk Investigational SiteSaint-Priest En Jarez, France, 42270 Gsk Investigational SiteStrasbourg, France, 67000|Bologna, Emilia-Romagna, Italy, 40138 Gsk Investigational SiteModena, Emilia-Romagna, Italy, 41124|Pavia, Lombardia, Italy, 27100|Verona, Veneto, Italy, 37126 Korea, Republic Of Gsk Investigational SiteAnyang-Si, Gyeonggi-Do, Korea, Republic Of, 14068 Gsk Investigational SiteBusan, Korea, Republic Of, 49201 Gsk Investigational SiteGoyang-Si, Gyeonggi-Do, Korea, Republic Of, 10326 Gsk Investigational SiteIncheon, Korea, Republic Of, 405-760 Gsk Investigational SiteSeoul, Korea, Republic Of, 07061 Gsk Investigational SiteSeoul, Korea, Republic Of, 134-727 Gsk Investigational SiteSeoul, Korea, Republic Of, 07441|Bialystok, Poland, 15-540 Gsk Investigational SiteKatowice, Poland, 40-027 Gsk Investigational SiteLodz, Poland, 92-213 Gsk Investigational SiteSandomierz, Poland, 27-600 Gsk Investigational SiteTarnowskie Gory, Poland, 42-612 Gsk Investigational SiteZyrardow, Poland, 96-300|Constanta, Romania, 900591 Gsk Investigational SiteResita, Romania, 320166 Russian Federation Gsk Investigational SiteKazan, Russian Federation, 420012 Gsk Investigational SiteKolomna, Russian Federation, 140407 Gsk Investigational SiteKrasnodar, Russian Federation, 350029 Gsk Investigational SiteKrasnogorsk, Russian Federation, 143400 Gsk Investigational SiteMytischi, Russian Federation, 141009 Gsk Investigational SiteNovorossiysk, Russian Federation, 353915 Gsk Investigational SiteNovosibirsk, Russian Federation, 630087 Gsk Investigational SiteOmsk, Russian Federation, 644111 Gsk Investigational SiteOrenburg, Russian Federation, 460040 Gsk Investigational SitePenza, Russian Federation, 440034 Gsk Investigational SitePodolsk, Russian Federation, 142110 Gsk Investigational SiteSaint-Petersburg, Russian Federation, 194354 Gsk Investigational SiteSaint-Petersburg, Russian Federation, 197374 Gsk Investigational SiteSt-Petersburg, Russian Federation, 197110 Gsk Investigational SiteSt. Petersburg, Russian Federation, 193318 Gsk Investigational SiteSt. Petersburg, Russian Federation, 194104 Gsk Investigational SiteSt. Petersburg, Russian Federation, 196247 Gsk Investigational SiteUfa, Russian Federation, 450071 Gsk Investigational SiteYaroslavl, Russian Federation, 150062|Almeria, Spain, 04009 Gsk Investigational SiteBadalona, Spain, 08916 Gsk Investigational SiteBarcelona, Spain, 08035 Gsk Investigational SiteBarcelona, Spain, 08036 Gsk Investigational SiteGerona, Spain, 17007 Gsk Investigational SiteGranollers, Barcelona, Spain, 08041 Gsk Investigational SiteMadrid, Spain, 28100 Gsk Investigational SiteManises (Valencia), Spain, 46940 Gsk Investigational SiteSan SebastiÃ¡n De Los Reyes/Madrid, Spain Gsk Investigational SiteSanlÃºcar De Barrameda (CÃ¡diz), Spain, 11540|Bradford, United Kingdom, Bd5 0Na Gsk Investigational SiteLondon, United Kingdom, Se5 9Rs Gsk Investigational SiteSheffield, United Kingdom, S5 7Au Gsk Investigational SiteSwansea, United Kingdom, Sa6 6Nl|Mesa, Arizona, United States, 85210|Fresno, California, United States, 93720 Gsk Investigational SiteLos Angeles, California, United States, 90025 Gsk Investigational SiteParamount, California, United States, 90723|Middlebury, Connecticut, United States, 06762|Hollywood, Florida, United States, 33024 Gsk Investigational SiteMiami, Florida, United States, 33169 Gsk Investigational SiteTampa, Florida, United States, 33614|Macon, Georgia, United States, 31201|Meridian, Idaho, United States, 83642|Pittsfield, Massachusetts, United States, 01201|Minneapolis, Minnesota, United States, 55404|Kansas City, Missouri, United States, 64111 Gsk Investigational SiteSaint Louis, Missouri, United States, 63110|Albuquerque, New|Bronx, New York, United States, 10461 Gsk Investigational SiteCollege Point, New York, United States, 11356|Winston-Salem, North Carolina, United States, 27157|Oklahoma City, Oklahoma, United States, 73116|Houston, Texas, United States, 77004 Gsk Investigational SiteHouston, Texas, United States, 77099 Gsk Investigational SiteLufkin, Texas, United States, 75904|Alexandria, Virginia, United States, 22304 Gsk Investigational SiteHampton, Virginia, United States, 23666 Gsk Investigational SiteNorfolk, Virginia, United States, 23510","Arizona|California|Connecticut|Florida|Georgia|Idaho|Massachusetts|Minnesota|Missouri|New Mexico|New York|North Carolina|Oklahoma|Texas|Virginia","Argentina|Australia|Brazil|Canada|France|Italy|Poland|Romania|Spain|United Kingdom|United States","Buenos Aires Gsk Investigational Site|Santa Fe Gsk Investigational Site|Victoria Gsk Investigational Site|Gsk Investigational Site|ParanÃ¡ Gsk Investigational Site|Rio Grande Do Sul Gsk Investigational Site|SÃ£o Paulo Gsk Investigational Site|Ontario Gsk Investigational Site|Emilia-Romagna Gsk Investigational Site|Lombardia Gsk Investigational Site|Veneto Gsk Investigational Site",{"$nulls":3},"GSK Clinical Trials","2019-06-18","2020-05-25T16:36:57.056","2020-05-26T17:10:42.972","NCT03400033"]
["5ecbf429fe30261b1a048268","NCT03400033","2019-07-22","GlaxoSmithKline","GSK","Active, not recruiting","Anemia Studies in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat-Three-times Weekly Dosing in Dialysis (ASCEND-TD)","Daprodustat|Epoetin alfa","HIF Inhibitor|ESA Activator","Yes","['Daprodustat']","Yes","['HIF Inhibitor']","Phase 3",2,402,"Anticipated","2018-09-05","2020-07-08",{"$nulls":5},"This Phase 3 study in hemodialysis-dependent subjects with anemia will evaluate the efficacy and safety of daprodustat administered three-times weekly compared to epoetin alfa, the current standard of care. This study includes a 4 week Screening Period, a 52 week Treatment Period and a 4 to 6 week follow-up period. Each subject will remain in the study for up to 62 weeks. Approximately 402 subjects will be randomized to receive either daprodustat three times weekly or epoetin alfa three-times weekly or once weekly, depending on dose level.",null,"A Phase 3 Randomized, Double-blind, Active-controlled, Parallel-group, Multi-center Study in Hemodialysis Participants With Anemia of Chronic Kidney Disease to Evaluate the Efficacy, Safety and Pharmacokinetics of Three-times Weekly Dosing of Daprodustat Compared to Recombinant Human Erythropoietin, Following a Switch From Recombinant Human Erythropoietin or Its Analogs",204837,"Anaemia","Anemia","Hematologic Diseases","Heme & Lymph Diseases","Experimental|Active Comparator","Daprodustat|Epoetin alfa","Subjects randomized to this arm will receive daprodustat tablets titrated doses from 2 to 48 milligrams orally three-times weekly along with saline by IV route for the 52 weeks treatment period.|Subjects randomized to this arm will receive matching placebo tablets to daprodustat orally three-times weekly and Epoetin alfa by IV route for the 52 weeks treatment period.","Drug","Daprodustat tablets|Saline vials or bags|Matching placebo tablets|Epoetin alfa vials","Round, biconvex, white, film-coated tablet in unit dose strengths 2 and 4 milligrams (7 millimeter tablets), 6, 8 and 10 milligrams (9 millimeter tablets) administered by the oral route.|0.9% sodium chloride saline vials or bags administered by the IV route.|Matching placebo to daprodustat tablets supplied as round, biconvex, white, film-coated tablet in unit dose strengths 2 and 4 milligrams (7 millimeter tablets), 6, 8 and 10 milligrams (9 millimeter tablets) administered by the oral route.|Single-dose, preservative-free vials in unit dose strengths of 2000, 3000, 4000 and 10,000 Units/milliliter administered by the IV route.",null,"Daprodustat|Epoetin alfa","\n\n * Subject must be 18 to 99 years of age inclusive, at the time of signing the informed consent.\n * Use of any approved rhEPO or analog for at least 8 weeks prior to the screening visit and continuing during the screening period until randomization (Day 1).\n * Hgb concentration (measured by HemoCue) within the following range: Week -4: Hgb 8 to 11.5 grams/deciliter (5 to 7.1 millimoles/liter). If Hgb is 11.6 to 11.9 grams/deciliter (7.2 to 7.4 millimoles/liter), up to two retests are allowed; the retest value must be between 8 to 11.5 grams/deciliter (5 to 7.1 millimoles/liter). Day 1: Hgb 8 to 11 grams/deciliter (5 to 6.8 millimoles/liter) and receiving at least the minimum rhEPO or analog dose 3. Hgb>11 to 11.5 grams/deciliter (6.8 to 7.1 millimoles/liter) and receiving greater than the minimum rhEPO or analog dose 3.\n * On hemodialysis (including hemofiltration or hemodiafiltration) >90 days prior to screening and continuing during the screening period.\n * On hemodialysis (in-center) >=3 times per week.\n * Male and female subjects are eligible. A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: Not a woman of childbearing potential (WOCBP), or A WOCBP who agrees to follow the contraceptive guidance from at least 28 days prior to first dose of study treatment and for at least 28 days after the last dose of study treatment.\n * Capable of giving signed informed consent.\n * In France, a subject will be eligible for inclusion in this study if he or she is either affiliated to or beneficiary of a social security category.\n\n","\n\n * Planned living-related or living-unrelated kidney transplant within 52 weeks after randomization (Day 1).\n * Ferritin: <=100 nanograms/milliliter (<=100 micrograms/liter), at screening.\n * Transferrin saturation (TSAT): <=20 percent, at screening. If TSAT is 18 to 20 percent, then a retest using a new blood sample can be obtained within 7 days of the final laboratory report; the final retest value must be >20 percent to confirm eligibility.\n * Aplasias: History of bone marrow aplasia or pure red cell aplasia.\n * Conditions, other than anemia of CKD, which can affect erythropoiesis.\n * Myocardial infarction (MI) or acute coronary syndrome within 8 weeks prior to screening through to randomization (Day 1).\n * Stroke or transient ischemic attack within 8 weeks prior to screening through to randomization (Day 1).\n * Heart failure (HF): Chronic Class IV HF, as defined by the New York Heart Association (NYHA) functional classification system.\n * Current uncontrolled hypertension as determined by the investigator that would contraindicate the use of rhEPO.\n * Bazett's correction of QTc interval (QTcB): at Day 1: QTcB >500 milliseconds, or QTcB >530 milliseconds in subjects with bundle branch block. There is no QTc (corrected QT) exclusion for subjects with a predominantly ventricular paced rhythm.\n * Liver Disease: presence of any one of the following liver-related laboratory values or conditions, at screening, is exclusionary: ALT >2x upper limit of normal (ULN); Bilirubin >1.5x ULN; or Current unstable liver or biliary disease per investigator assessment, generally defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis.\n * Evidence of actively bleeding gastric, duodenal or esophageal ulcer disease OR clinically significant gastro intestinal bleeding <= 8 weeks prior to screening through to randomization (Day 1).\n * History of malignancy within 2 years prior to screening through to randomization (Day 1), currently receiving treatment for cancer, or complex kidney cyst (e.g., Bosniak Category IIF, III or IV) >3 centimeters.\n * Use of a strong inhibitor of Cytochrome P4502C8 [CYP2C8] (e.g. gemfibrozil) or a strong inducer of CYP2C8 (e.g. rifampin/rifampicin).\n * History of severe allergic or anaphylactic reactions or hypersensitivity to excipients in the investigational product (daprodustat) or epoetin alfa.\n * Use of another investigational agent within 30 days or within five half-lives of the investigational agent (whichever is longer) or currently participating in a study of an investigational device prior to screening through to randomization (Day 1).\n * Any prior treatment with daprodustat for treatment duration of >30 days.\n * Any other condition, clinical or laboratory abnormality, or examination finding that the investigator considers would put the subject at unacceptable risk, which may affect study compliance (e.g. intolerance to rhEPO) or prevent understanding of the aims or investigational procedures or possible consequences of the study.",{"$nulls":4},"Actual","2018-01-17","Actual","Anticipated","2020-07-08","Anticipated","2019-07-01","2018-01-08","2018-01-08","2019-07-19","Yes","CKD, EPO, rhEPO, Hemodialysis dependent, Daprodustat","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years","99 Years","All",null,"No","Yes\nIPD for this study will be made available via the Clinical Study Data Request site.",{"$nulls":3},"Yes","No",{"$nulls":17},"2017-004372-56","EudraCT Number","Mean change in Hemoglobin (Hgb) between Baseline and over Evaluation period [EP] (Weeks 28 to 52)","Blood samples will be collected from subjects for Hgb measurements.","Baseline and up to Week 52","Mean monthly intravenous (IV) iron dose per subject up to Week 52|Number of subjects with adverse events (AEs), serious adverse events (SAEs), adverse event of special interest (AESI) and MACE|Percentage of time Hgb will be in the analysis range (10 to 11.5 grams/deciliter) over EP (Weeks 28 to 52)|Time to stopping study treatment due to meeting rescue criteria|Number of responders in the Hgb analysis range over EP (Weeks 28 to 52)|Change from Baseline in SBP, DBP and mean arterial pressure (MAP) at Week 52 and at the end of study treatment|Number of BP exacerbation events per 100 subject years|Number of subjects with at least one BP exacerbation event during the study|Pre-dose trough concentration (Ctau) of daprodustat|Pre-dose Ctau of metabolites M2|Pre-dose Ctau of metabolites M4|Pre-dose Ctau of metabolites M3|Pre-dose Ctau of metabolites M5|Pre-dose Ctau of metabolites M6|Pre-dose Ctau of metabolites M13|Maximum observed concentration (Cmax) of daprodustat|Cmax of metabolites M2|Cmax of metabolites M3|Cmax of metabolites M4|Cmax of metabolites M5|Cmax of metabolites M6|Cmax of metabolites M13|Change from Baseline in Patient Global Impression of Severity (PGI-S) score|Absolute values over time for composite of hematology parameters as a measure of safety|Changes from baseline over time in composite of hematology parameters as a measure of safety|Absolute values over time for composite of chemistry parameters as a measure of safety|Changes from baseline over time in composite of chemistry parameters as a measure of safety|Absolute values of systolic and diastolic blood pressure as a measure of safety|Change from Baseline in systolic and diastolic blood pressure as a measure of safety|Absolute values for heart rate as a measure of safety|Change from Baseline in Heart rate as a measure of safety","IV iron use for all subjects will be recorded in the electronic case record form (eCRF) and the average monthly IV iron dose up to Week 52 while on treatment will be calculated.|AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is medically significant. Along with AE and SAE the study will also assess AESI and MACE events until follow-up Week 52.|Subjects will be treated to achieve and maintain Hgb between 10 and 11.5 grams/deciliter. The study treatment may be dose-titrated, if needed, during EP to achieve or maintain Hgb level in the target range.|A rescue algorithm is provided to minimize subjects having an inadequate response to the treatment for their anemia for an extended period of time and to enable consistency in the application of rescue therapy across the study. The time to stopping of study treatment due to subjects meeting the rescue criteria will be assessed. The date and time of rescue medication administration as well as the name and dosage regimen of the rescue medication must be recorded.|A responder is defined as a subject with mean Hgb within the Hgb analysis range 10 to 11.5 grams/deciliter during the EP. Subjects will be treated to achieve and maintain Hgb between 10 and 11.5 grams/deciliter. The study treatment may be dose-titrated, if needed, during EP to achieve or maintain Hgb level in the target range.|MAP is an average BP in an individual during a single cardiac cycle. Measurements will be taken both pre-dialysis and post-dialysis. Measurements will be taken with the subject is in a semi-supine or seated position in the dialysis chair after at least a 5-minute rest period, pre- and post-dialysis. Measurement of SBP, DBP and MAP will be performed before collection of blood samples for laboratory testing, where applicable.|The calculation of events per subject-years is the number of incident cases divided by the amount of subjects-time at risk. Number of BP exacerbation events per 100 subject years will be calculated.|Number of subjects with at least 1 BP exacerbation event up to Week 52 will be calculated.|Blood samples (6 in total) will be collected at the Day 1 visit pre-dose and at any one post-Baseline visit between Week 8 and Week 52.|Change from Baseline in global symptom severity will be assessed. Symptom severity will be assessed using the PGI-S. The PGI-S is a 1-item questionnaire designed to assess subjects impression of disease severity of their anemia of CKD.|The following hematology parameters will be measured: Hemoglobin, Hematocrit, RBC count, Mean corpuscular volume (MCV), Mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), Red cell distribution width (RDW), Reticulocyte count, Platelet count, white blood cell (WBC) count, Total neutrophils, Eosinophils, Monocytes, Basophils, and Lymphocytes|The following chemistry parameters will be measured: Potassium, Albumin, Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Calcium, Phosphate, Total and direct/indirect bilirubin, and urea (serum).|Measurements will be taken both pre-dialysis and post-dialysis. Measurements will be taken with the subject is in a semi-supine or seated position in the dialysis chair after at least a 5-minute rest period, pre and post-dialysis. Measurement of SBP and DBP will be performed before collection of blood samples for laboratory testing, where applicable.|Measurements will be taken both pre-dialysis and post-dialysis. Measurements will be taken with the subject is in a semi-supine or seated position in the dialysis chair after at least a 5-minute rest period, pre and post-dialysis. Measurement of heart rate will be performed before collection of blood samples for laboratory testing, where applicable.","Up to Week 52|Weeks 28 to 52|Baseline and Week 52|Pre-dose at any one post-Baseline visit between Week 8 and Week 52|Pre-dose and 0.5, 1, 2, 3 hours|Pre-dose and 0.5, 1, 2, 3 hours post-dose|Baseline and up to Week 52",{"$nulls":3},"Mar Del Plata, Buenos Aires, Argentina, 7600 Gsk Investigational SitePergamino, Buenos Aires, Argentina, B2700Cpm Gsk Investigational SiteSarandi, Buenos Aires, Argentina, B1872Eeb|Rosario, Santa Fe, Argentina, 2000|Heidelberg, Victoria, Australia, 3084 Gsk Investigational SiteParkville, Victoria, Australia, 3050|Belo Horizonte, Minas Gerais, Brazil, 30150-221 Gsk Investigational SiteFeira De Santana, Brazil, 44001-465 Gsk Investigational SiteSÃ£o Paulo, Brazil, 04039-000|Curitiba, ParanÃ¡, Brazil, 80440-020|Passo Fundo, Rio Grande Do Sul, Brazil, 99010-080 Gsk Investigational SitePorto Alegre, Rio Grande Do Sul, Brazil, 90610-000|Sao Jose Do Rio Preto, SÃ£o Paulo, Brazil, 15090-000|Oshawa, Ontario, Canada, L1G 2B9|Bayonne, France, 64109 Gsk Investigational SiteEpagny Metz-Tessy, France, 74370 Gsk Investigational SiteLe Mans, France, 72037 Gsk Investigational SiteNice Cedex 1, France, 06001 Gsk Investigational SiteStrasbourg, France, 67000|Bologna, Emilia-Romagna, Italy, 40138 Gsk Investigational SiteModena, Emilia-Romagna, Italy, 41124|Pavia, Lombardia, Italy, 27100|Verona, Veneto, Italy, 37126 Korea, Republic Of Gsk Investigational SiteAnyang-Si, Gyeonggi-Do, Korea, Republic Of, 14068 Gsk Investigational SiteBusan, Korea, Republic Of, 49201 Gsk Investigational SiteGoyang-Si, Gyeonggi-Do, Korea, Republic Of, 10326 Gsk Investigational SiteIncheon, Korea, Republic Of, 405-760 Gsk Investigational SiteSeoul, Korea, Republic Of, 07061 Gsk Investigational SiteSeoul, Korea, Republic Of, 134-727 Gsk Investigational SiteSeoul, Korea, Republic Of, 07441|Katowice, Poland, 40-027 Gsk Investigational SiteLodz, Poland, 92-213 Gsk Investigational SiteSandomierz, Poland, 27-600 Gsk Investigational SiteTarnowskie Gory, Poland, 42-612 Gsk Investigational SiteZyrardow, Poland, 96-300|Constanta, Romania, 900591 Gsk Investigational SiteResita, Romania, 320166 Russian Federation Gsk Investigational SiteKazan, Russian Federation, 420012 Gsk Investigational SiteKolomna, Russian Federation, 140407 Gsk Investigational SiteKrasnodar, Russian Federation, 350029 Gsk Investigational SiteKrasnogorsk, Russian Federation, 143400 Gsk Investigational SiteMytischi, Russian Federation, 141009 Gsk Investigational SiteNovorossiysk, Russian Federation, 353915 Gsk Investigational SiteNovosibirsk, Russian Federation, 630087 Gsk Investigational SiteOmsk, Russian Federation, 644111 Gsk Investigational SiteOrenburg, Russian Federation, 460040 Gsk Investigational SitePenza, Russian Federation, 440034 Gsk Investigational SitePodolsk, Russian Federation, 142110 Gsk Investigational SiteSaint-Petersburg, Russian Federation, 194354 Gsk Investigational SiteSaint-Petersburg, Russian Federation, 197374 Gsk Investigational SiteSt-Petersburg, Russian Federation, 197110 Gsk Investigational SiteSt. Petersburg, Russian Federation, 193318 Gsk Investigational SiteSt. Petersburg, Russian Federation, 194104 Gsk Investigational SiteSt. Petersburg, Russian Federation, 196247 Gsk Investigational SiteUfa, Russian Federation, 450071 Gsk Investigational SiteYaroslavl, Russian Federation, 150062|Almeria, Spain, 04009 Gsk Investigational SiteBadalona, Spain, 08916 Gsk Investigational SiteBarcelona, Spain, 08036 Gsk Investigational SiteGerona, Spain, 17007 Gsk Investigational SiteGranollers, Barcelona, Spain, 08041 Gsk Investigational SiteMadrid, Spain, 28100 Gsk Investigational SiteManises (Valencia), Spain, 46940 Gsk Investigational SiteSan SebastiÃ¡n De Los Reyes/Madrid, Spain Gsk Investigational SiteSanlÃºcar De Barrameda (CÃ¡diz), Spain, 11540|Bradford, United Kingdom, Bd5 0Na Gsk Investigational SiteLondon, United Kingdom, Se5 9Rs Gsk Investigational SiteSheffield, United Kingdom, S5 7Au Gsk Investigational SiteSwansea, United Kingdom, Sa6 6Nl|Mesa, Arizona, United States, 85210|Fresno, California, United States, 93720 Gsk Investigational SiteLos Angeles, California, United States, 90025 Gsk Investigational SiteParamount, California, United States, 90723|Middlebury, Connecticut, United States, 06762|Hollywood, Florida, United States, 33024 Gsk Investigational SiteMiami, Florida, United States, 33169 Gsk Investigational SiteTampa, Florida, United States, 33614|Macon, Georgia, United States, 31201|Meridian, Idaho, United States, 83642|Pittsfield, Massachusetts, United States, 01201|Minneapolis, Minnesota, United States, 55404|Kansas City, Missouri, United States, 64111 Gsk Investigational SiteSaint Louis, Missouri, United States, 63110|Albuquerque, New|Bronx, New York, United States, 10461 Gsk Investigational SiteCollege Point, New York, United States, 11356|Winston-Salem, North Carolina, United States, 27157|Oklahoma City, Oklahoma, United States, 73116|Houston, Texas, United States, 77004 Gsk Investigational SiteHouston, Texas, United States, 77099 Gsk Investigational SiteLufkin, Texas, United States, 75904|Alexandria, Virginia, United States, 22304 Gsk Investigational SiteHampton, Virginia, United States, 23666 Gsk Investigational SiteNorfolk, Virginia, United States, 23510","Arizona|California|Connecticut|Florida|Georgia|Idaho|Massachusetts|Minnesota|Missouri|New Mexico|New York|North Carolina|Oklahoma|Texas|Virginia","Argentina|Australia|Brazil|Canada|France|Italy|Poland|Romania|Spain|United Kingdom|United States","Buenos Aires Gsk Investigational Site|Santa Fe Gsk Investigational Site|Victoria Gsk Investigational Site|Gsk Investigational Site|ParanÃ¡ Gsk Investigational Site|Rio Grande Do Sul Gsk Investigational Site|SÃ£o Paulo Gsk Investigational Site|Ontario Gsk Investigational Site|Emilia-Romagna Gsk Investigational Site|Lombardia Gsk Investigational Site|Veneto Gsk Investigational Site",{"$nulls":3},"GSK Clinical Trials","2019-07-19","2020-05-25T16:36:57.037","2020-05-26T17:10:42.972","NCT03400033"]
["5ecbf429fe30261b1a048269","NCT03400033","2020-01-22","GlaxoSmithKline","GSK","Active, not recruiting","Anemia Studies in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat-Three-times Weekly Dosing in Dialysis (ASCEND-TD)","Daprodustat|Epoetin alfa","HIF Inhibitor|ESA Activator","Yes","['Daprodustat']","Yes","['HIF Inhibitor']","Phase 3",2,407,"Actual","2018-09-05","2020-07-08",{"$nulls":5},"This Phase 3 study in hemodialysis-dependent subjects with anemia will evaluate the efficacy and safety of daprodustat administered three-times weekly compared to epoetin alfa, the current standard of care. This study includes a 4 week Screening Period, a 52 week Treatment Period and a 4 to 6 week follow-up period. Each subject will remain in the study for up to 62 weeks. Approximately 402 subjects will be randomized to receive either daprodustat three times weekly or epoetin alfa three-times weekly or once weekly, depending on dose level.",null,"A Phase 3 Randomized, Double-blind, Active-controlled, Parallel-group, Multi-center Study in Hemodialysis Participants With Anemia of Chronic Kidney Disease to Evaluate the Efficacy, Safety and Pharmacokinetics of Three-times Weekly Dosing of Daprodustat Compared to Recombinant Human Erythropoietin, Following a Switch From Recombinant Human Erythropoietin or Its Analogs",204837,"Anaemia","Anemia","Hematologic Diseases","Heme & Lymph Diseases","Experimental|Active Comparator","Daprodustat|Epoetin alfa","Subjects randomized to this arm will receive daprodustat tablets titrated doses from 2 to 48 milligrams orally three-times weekly along with saline by IV route for the 52 weeks treatment period.|Subjects randomized to this arm will receive matching placebo tablets to daprodustat orally three-times weekly and Epoetin alfa by IV route for the 52 weeks treatment period.","Drug","Daprodustat tablets|Saline vials or bags|Matching placebo tablets|Epoetin alfa vials","Round, biconvex, white, film-coated tablet in unit dose strengths 2 and 4 milligrams (7 millimeter tablets), 6, 8 and 10 milligrams (9 millimeter tablets) administered by the oral route.|0.9% sodium chloride saline vials or bags administered by the IV route.|Matching placebo to daprodustat tablets supplied as round, biconvex, white, film-coated tablet in unit dose strengths 2 and 4 milligrams (7 millimeter tablets), 6, 8 and 10 milligrams (9 millimeter tablets) administered by the oral route.|Single-dose, preservative-free vials in unit dose strengths of 2000, 3000, 4000 and 10,000 Units/milliliter administered by the IV route.",null,"Daprodustat|Epoetin alfa","\n\n * Subject must be 18 to 99 years of age inclusive, at the time of signing the informed consent.\n * Use of any approved rhEPO or analog for at least 8 weeks prior to the screening visit and continuing during the screening period until randomization (Day 1).\n * Hgb concentration (measured by HemoCue) within the following range: Week -4: Hgb 8 to 11.5 grams/deciliter (5 to 7.1 millimoles/liter). If Hgb is 11.6 to 11.9 grams/deciliter (7.2 to 7.4 millimoles/liter), up to two retests are allowed; the retest value must be between 8 to 11.5 grams/deciliter (5 to 7.1 millimoles/liter). Day 1: Hgb 8 to 11 grams/deciliter (5 to 6.8 millimoles/liter) and receiving at least the minimum rhEPO or analog dose 3. Hgb>11 to 11.5 grams/deciliter (6.8 to 7.1 millimoles/liter) and receiving greater than the minimum rhEPO or analog dose 3.\n * On hemodialysis (including hemofiltration or hemodiafiltration) >90 days prior to screening and continuing during the screening period.\n * On hemodialysis (in-center) >=3 times per week.\n * Male and female subjects are eligible. A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: Not a woman of childbearing potential (WOCBP), or A WOCBP who agrees to follow the contraceptive guidance from at least 28 days prior to first dose of study treatment and for at least 28 days after the last dose of study treatment.\n * Capable of giving signed informed consent.\n * In France, a subject will be eligible for inclusion in this study if he or she is either affiliated to or beneficiary of a social security category.\n\n","\n\n * Planned living-related or living-unrelated kidney transplant within 52 weeks after randomization (Day 1).\n * Ferritin: <=100 nanograms/milliliter (<=100 micrograms/liter), at screening.\n * Transferrin saturation (TSAT): <=20 percent, at screening. If TSAT is 18 to 20 percent, then a retest using a new blood sample can be obtained within 7 days of the final laboratory report; the final retest value must be >20 percent to confirm eligibility.\n * Aplasias: History of bone marrow aplasia or pure red cell aplasia.\n * Conditions, other than anemia of CKD, which can affect erythropoiesis.\n * Myocardial infarction (MI) or acute coronary syndrome within 8 weeks prior to screening through to randomization (Day 1).\n * Stroke or transient ischemic attack within 8 weeks prior to screening through to randomization (Day 1).\n * Heart failure (HF): Chronic Class IV HF, as defined by the New York Heart Association (NYHA) functional classification system.\n * Current uncontrolled hypertension as determined by the investigator that would contraindicate the use of rhEPO.\n * Bazett's correction of QTc interval (QTcB): at Day 1: QTcB >500 milliseconds, or QTcB >530 milliseconds in subjects with bundle branch block. There is no QTc (corrected QT) exclusion for subjects with a predominantly ventricular paced rhythm.\n * Liver Disease: presence of any one of the following liver-related laboratory values or conditions, at screening, is exclusionary: ALT >2x upper limit of normal (ULN); Bilirubin >1.5x ULN; or Current unstable liver or biliary disease per investigator assessment, generally defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis.\n * Evidence of actively bleeding gastric, duodenal or esophageal ulcer disease OR clinically significant gastro intestinal bleeding <= 8 weeks prior to screening through to randomization (Day 1).\n * History of malignancy within 2 years prior to screening through to randomization (Day 1), currently receiving treatment for cancer, or complex kidney cyst (e.g., Bosniak Category IIF, III or IV) >3 centimeters.\n * Use of a strong inhibitor of Cytochrome P4502C8 [CYP2C8] (e.g. gemfibrozil) or a strong inducer of CYP2C8 (e.g. rifampin/rifampicin).\n * History of severe allergic or anaphylactic reactions or hypersensitivity to excipients in the investigational product (daprodustat) or epoetin alfa.\n * Use of another investigational agent within 30 days or within five half-lives of the investigational agent (whichever is longer) or currently participating in a study of an investigational device prior to screening through to randomization (Day 1).\n * Any prior treatment with daprodustat for treatment duration of >30 days.\n * Any other condition, clinical or laboratory abnormality, or examination finding that the investigator considers would put the subject at unacceptable risk, which may affect study compliance (e.g. intolerance to rhEPO) or prevent understanding of the aims or investigational procedures or possible consequences of the study.",{"$nulls":4},"Actual","2018-01-17","Actual","Anticipated","2020-07-08","Anticipated","2020-01-01","2018-01-08","2018-01-08","2020-01-17","Yes","CKD, EPO, rhEPO, Hemodialysis dependent, Daprodustat","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years","99 Years","All",null,"No","Yes\nIPD for this study will be made available via the Clinical Study Data Request site.",{"$nulls":3},"Yes","No",{"$nulls":17},"2017-004372-56","EudraCT Number","Mean change in Hemoglobin (Hgb) between Baseline and over Evaluation period [EP] (Weeks 28 to 52)","Blood samples will be collected from subjects for Hgb measurements.","Baseline and up to Week 52","Mean monthly intravenous (IV) iron dose per subject up to Week 52|Number of subjects with adverse events (AEs), serious adverse events (SAEs), adverse event of special interest (AESI) and MACE|Percentage of time Hgb will be in the analysis range (10 to 11.5 grams/deciliter) over EP (Weeks 28 to 52)|Time to stopping study treatment due to meeting rescue criteria|Number of responders in the Hgb analysis range over EP (Weeks 28 to 52)|Change from Baseline in SBP, DBP and mean arterial pressure (MAP) at Week 52 and at the end of study treatment|Number of BP exacerbation events per 100 subject years|Number of subjects with at least one BP exacerbation event during the study|Pre-dose trough concentration (Ctau) of daprodustat|Pre-dose Ctau of metabolites M2|Pre-dose Ctau of metabolites M4|Pre-dose Ctau of metabolites M3|Pre-dose Ctau of metabolites M5|Pre-dose Ctau of metabolites M6|Pre-dose Ctau of metabolites M13|Maximum observed concentration (Cmax) of daprodustat|Cmax of metabolites M2|Cmax of metabolites M3|Cmax of metabolites M4|Cmax of metabolites M5|Cmax of metabolites M6|Cmax of metabolites M13|Change from Baseline in Patient Global Impression of Severity (PGI-S) score|Absolute values over time for composite of hematology parameters as a measure of safety|Changes from baseline over time in composite of hematology parameters as a measure of safety|Absolute values over time for composite of chemistry parameters as a measure of safety|Changes from baseline over time in composite of chemistry parameters as a measure of safety|Absolute values of systolic and diastolic blood pressure as a measure of safety|Change from Baseline in systolic and diastolic blood pressure as a measure of safety|Absolute values for heart rate as a measure of safety|Change from Baseline in Heart rate as a measure of safety","IV iron use for all subjects will be recorded in the electronic case record form (eCRF) and the average monthly IV iron dose up to Week 52 while on treatment will be calculated.|AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is medically significant. Along with AE and SAE the study will also assess AESI and MACE events until follow-up Week 52.|Subjects will be treated to achieve and maintain Hgb between 10 and 11.5 grams/deciliter. The study treatment may be dose-titrated, if needed, during EP to achieve or maintain Hgb level in the target range.|A rescue algorithm is provided to minimize subjects having an inadequate response to the treatment for their anemia for an extended period of time and to enable consistency in the application of rescue therapy across the study. The time to stopping of study treatment due to subjects meeting the rescue criteria will be assessed. The date and time of rescue medication administration as well as the name and dosage regimen of the rescue medication must be recorded.|A responder is defined as a subject with mean Hgb within the Hgb analysis range 10 to 11.5 grams/deciliter during the EP. Subjects will be treated to achieve and maintain Hgb between 10 and 11.5 grams/deciliter. The study treatment may be dose-titrated, if needed, during EP to achieve or maintain Hgb level in the target range.|MAP is an average BP in an individual during a single cardiac cycle. Measurements will be taken both pre-dialysis and post-dialysis. Measurements will be taken with the subject is in a semi-supine or seated position in the dialysis chair after at least a 5-minute rest period, pre- and post-dialysis. Measurement of SBP, DBP and MAP will be performed before collection of blood samples for laboratory testing, where applicable.|The calculation of events per subject-years is the number of incident cases divided by the amount of subjects-time at risk. Number of BP exacerbation events per 100 subject years will be calculated.|Number of subjects with at least 1 BP exacerbation event up to Week 52 will be calculated.|Blood samples (6 in total) will be collected at the Day 1 visit pre-dose and at any one post-Baseline visit between Week 8 and Week 52.|Change from Baseline in global symptom severity will be assessed. Symptom severity will be assessed using the PGI-S. The PGI-S is a 1-item questionnaire designed to assess subjects impression of disease severity of their anemia of CKD.|The following hematology parameters will be measured: Hemoglobin, Hematocrit, RBC count, Mean corpuscular volume (MCV), Mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), Red cell distribution width (RDW), Reticulocyte count, Platelet count, white blood cell (WBC) count, Total neutrophils, Eosinophils, Monocytes, Basophils, and Lymphocytes|The following chemistry parameters will be measured: Potassium, Albumin, Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Calcium, Phosphate, Total and direct/indirect bilirubin, and urea (serum).|Measurements will be taken both pre-dialysis and post-dialysis. Measurements will be taken with the subject is in a semi-supine or seated position in the dialysis chair after at least a 5-minute rest period, pre and post-dialysis. Measurement of SBP and DBP will be performed before collection of blood samples for laboratory testing, where applicable.|Measurements will be taken both pre-dialysis and post-dialysis. Measurements will be taken with the subject is in a semi-supine or seated position in the dialysis chair after at least a 5-minute rest period, pre and post-dialysis. Measurement of heart rate will be performed before collection of blood samples for laboratory testing, where applicable.","Up to Week 52|Weeks 28 to 52|Baseline and Week 52|Pre-dose at any one post-Baseline visit between Week 8 and Week 52|Pre-dose and 0.5, 1, 2, 3 hours|Pre-dose and 0.5, 1, 2, 3 hours post-dose|Baseline and up to Week 52",{"$nulls":3},"Mar Del Plata, Buenos Aires, Argentina, 7600 Gsk Investigational SitePergamino, Buenos Aires, Argentina, B2700Cpm Gsk Investigational SiteSarandi, Buenos Aires, Argentina, B1872Eeb|Rosario, Santa Fe, Argentina, 2000|Heidelberg, Victoria, Australia, 3084 Gsk Investigational SiteParkville, Victoria, Australia, 3050|Belo Horizonte, Minas Gerais, Brazil, 30150-221 Gsk Investigational SiteFeira De Santana, Brazil, 44001-465 Gsk Investigational SiteSÃ£o Paulo, Brazil, 04039-000|Curitiba, ParanÃ¡, Brazil, 80440-020|Passo Fundo, Rio Grande Do Sul, Brazil, 99010-080 Gsk Investigational SitePorto Alegre, Rio Grande Do Sul, Brazil, 90610-000|Sao Jose Do Rio Preto, SÃ£o Paulo, Brazil, 15090-000|Oshawa, Ontario, Canada, L1G 2B9|Bayonne, France, 64109 Gsk Investigational SiteEpagny Metz-Tessy, France, 74370 Gsk Investigational SiteLe Mans, France, 72037 Gsk Investigational SiteNice Cedex 1, France, 06001 Gsk Investigational SiteStrasbourg, France, 67000|Bologna, Emilia-Romagna, Italy, 40138 Gsk Investigational SiteModena, Emilia-Romagna, Italy, 41124|Pavia, Lombardia, Italy, 27100|Verona, Veneto, Italy, 37126 Korea, Republic Of Gsk Investigational SiteAnyang-Si, Gyeonggi-Do, Korea, Republic Of, 14068 Gsk Investigational SiteBusan, Korea, Republic Of, 49201 Gsk Investigational SiteGoyang-Si, Gyeonggi-Do, Korea, Republic Of, 10326 Gsk Investigational SiteIncheon, Korea, Republic Of, 405-760 Gsk Investigational SiteSeoul, Korea, Republic Of, 07061 Gsk Investigational SiteSeoul, Korea, Republic Of, 134-727 Gsk Investigational SiteSeoul, Korea, Republic Of, 07441|Katowice, Poland, 40-027 Gsk Investigational SiteLodz, Poland, 92-213 Gsk Investigational SiteSandomierz, Poland, 27-600 Gsk Investigational SiteTarnowskie Gory, Poland, 42-612 Gsk Investigational SiteZyrardow, Poland, 96-300|Constanta, Romania, 900591 Gsk Investigational SiteResita, Romania, 320166 Russian Federation Gsk Investigational SiteKazan, Russian Federation, 420012 Gsk Investigational SiteKolomna, Russian Federation, 140402 Gsk Investigational SiteKrasnodar, Russian Federation, 350029 Gsk Investigational SiteKrasnogorsk, Russian Federation, 143400 Gsk Investigational SiteMytischi, Russian Federation, 141009 Gsk Investigational SiteNovorossiysk, Russian Federation, 353915 Gsk Investigational SiteNovosibirsk, Russian Federation, 630087 Gsk Investigational SiteOmsk, Russian Federation, 644111 Gsk Investigational SiteOrenburg, Russian Federation, 460040 Gsk Investigational SitePenza, Russian Federation, 440034 Gsk Investigational SitePodolsk, Russian Federation, 142110 Gsk Investigational SiteSaint-Petersburg, Russian Federation, 194354 Gsk Investigational SiteSaint-Petersburg, Russian Federation, 197374 Gsk Investigational SiteSt-Petersburg, Russian Federation, 197110 Gsk Investigational SiteSt. Petersburg, Russian Federation, 193318 Gsk Investigational SiteSt. Petersburg, Russian Federation, 194104 Gsk Investigational SiteSt. Petersburg, Russian Federation, 196247 Gsk Investigational SiteUfa, Russian Federation, 450071 Gsk Investigational SiteYaroslavl, Russian Federation, 150062|Almeria, Spain, 04009 Gsk Investigational SiteBadalona, Spain, 08916 Gsk Investigational SiteBarcelona, Spain, 08036 Gsk Investigational SiteGerona, Spain, 17007 Gsk Investigational SiteGranollers, Barcelona, Spain, 08041 Gsk Investigational SiteMadrid, Spain, 28100 Gsk Investigational SiteManises (Valencia), Spain, 46940 Gsk Investigational SiteSan SebastiÃ¡n De Los Reyes/Madrid, Spain Gsk Investigational SiteSanlÃºcar De Barrameda (CÃ¡diz), Spain, 11540|Bradford, United Kingdom, Bd5 0Na Gsk Investigational SiteLondon, United Kingdom, Se5 9Rs Gsk Investigational SiteSheffield, United Kingdom, S5 7Au Gsk Investigational SiteSwansea, United Kingdom, Sa6 6Nl|Mesa, Arizona, United States, 85210|Fresno, California, United States, 93720 Gsk Investigational SiteLos Angeles, California, United States, 90025 Gsk Investigational SiteParamount, California, United States, 90723|Middlebury, Connecticut, United States, 06762|Hollywood, Florida, United States, 33024 Gsk Investigational SiteMiami, Florida, United States, 33169 Gsk Investigational SiteTampa, Florida, United States, 33614|Macon, Georgia, United States, 31201|Meridian, Idaho, United States, 83642|Pittsfield, Massachusetts, United States, 01201|Kansas City, Missouri, United States, 64111 Gsk Investigational SiteSaint Louis, Missouri, United States, 63110|Albuquerque, New|College Point, New York, United States, 11356|Winston-Salem, North Carolina, United States, 27157|Oklahoma City, Oklahoma, United States, 73116|Houston, Texas, United States, 77004 Gsk Investigational SiteHouston, Texas, United States, 77099 Gsk Investigational SiteLufkin, Texas, United States, 75904|Alexandria, Virginia, United States, 22304 Gsk Investigational SiteHampton, Virginia, United States, 23666 Gsk Investigational SiteNorfolk, Virginia, United States, 23510","Arizona|California|Connecticut|Florida|Georgia|Idaho|Massachusetts|Missouri|New Mexico|New York|North Carolina|Oklahoma|Texas|Virginia","Argentina|Australia|Brazil|Canada|France|Italy|Poland|Romania|Spain|United Kingdom|United States","Buenos Aires Gsk Investigational Site|Santa Fe Gsk Investigational Site|Victoria Gsk Investigational Site|Gsk Investigational Site|ParanÃ¡ Gsk Investigational Site|Rio Grande Do Sul Gsk Investigational Site|SÃ£o Paulo Gsk Investigational Site|Ontario Gsk Investigational Site|Emilia-Romagna Gsk Investigational Site|Lombardia Gsk Investigational Site|Veneto Gsk Investigational Site",{"$nulls":3},"GSK Clinical Trials","2020-01-17","2020-05-25T16:36:57.323","2020-05-26T17:10:42.972","NCT03400033"]
["5ecbf429e2561b1b11905d64","NCT03400033","2020-02-05","GlaxoSmithKline","GSK","Active, not recruiting","Anemia Studies in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat-Three-times Weekly Dosing in Dialysis (ASCEND-TD)","Daprodustat|Epoetin alfa","HIF Inhibitor|ESA Activator","Yes","['Daprodustat']","Yes","['HIF Inhibitor']","Phase 3",2,407,"Actual","2018-09-05","2020-07-08",{"$nulls":5},"This Phase 3 study in hemodialysis-dependent subjects with anemia will evaluate the efficacy and safety of daprodustat administered three-times weekly compared to epoetin alfa, the current standard of care. This study includes a 4 week Screening Period, a 52 week Treatment Period and a 4 to 6 week follow-up period. Each subject will remain in the study for up to 62 weeks. Approximately 402 subjects will be randomized to receive either daprodustat three times weekly or epoetin alfa three-times weekly or once weekly, depending on dose level.",null,"A Phase 3 Randomized, Double-blind, Active-controlled, Parallel-group, Multi-center Study in Hemodialysis Participants With Anemia of Chronic Kidney Disease to Evaluate the Efficacy, Safety and Pharmacokinetics of Three-times Weekly Dosing of Daprodustat Compared to Recombinant Human Erythropoietin, Following a Switch From Recombinant Human Erythropoietin or Its Analogs",204837,"Anaemia","Anemia","Hematologic Diseases","Heme & Lymph Diseases","Experimental|Active Comparator","Daprodustat|Epoetin alfa","Subjects randomized to this arm will receive daprodustat tablets titrated doses from 2 to 48 milligrams orally three-times weekly along with saline by IV route for the 52 weeks treatment period.|Subjects randomized to this arm will receive matching placebo tablets to daprodustat orally three-times weekly and Epoetin alfa by IV route for the 52 weeks treatment period.","Drug","Daprodustat tablets|Saline vials or bags|Matching placebo tablets|Epoetin alfa vials","Round, biconvex, white, film-coated tablet in unit dose strengths 2 and 4 milligrams (7 millimeter tablets), 6, 8 and 10 milligrams (9 millimeter tablets) administered by the oral route.|0.9% sodium chloride saline vials or bags administered by the IV route.|Matching placebo to daprodustat tablets supplied as round, biconvex, white, film-coated tablet in unit dose strengths 2 and 4 milligrams (7 millimeter tablets), 6, 8 and 10 milligrams (9 millimeter tablets) administered by the oral route.|Single-dose, preservative-free vials in unit dose strengths of 2000, 3000, 4000 and 10,000 Units/milliliter administered by the IV route.",null,"Daprodustat|Epoetin alfa","\n\n * Subject must be 18 to 99 years of age inclusive, at the time of signing the informed consent.\n * Use of any approved rhEPO or analog for at least 8 weeks prior to the screening visit and continuing during the screening period until randomization (Day 1).\n * Hgb concentration (measured by HemoCue) within the following range: Week -4: Hgb 8 to 11.5 grams/deciliter (5 to 7.1 millimoles/liter). If Hgb is 11.6 to 11.9 grams/deciliter (7.2 to 7.4 millimoles/liter), up to two retests are allowed; the retest value must be between 8 to 11.5 grams/deciliter (5 to 7.1 millimoles/liter). Day 1: Hgb 8 to 11 grams/deciliter (5 to 6.8 millimoles/liter) and receiving at least the minimum rhEPO or analog dose 3. Hgb>11 to 11.5 grams/deciliter (6.8 to 7.1 millimoles/liter) and receiving greater than the minimum rhEPO or analog dose 3.\n * On hemodialysis (including hemofiltration or hemodiafiltration) >90 days prior to screening and continuing during the screening period.\n * On hemodialysis (in-center) >=3 times per week.\n * Male and female subjects are eligible. A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: Not a woman of childbearing potential (WOCBP), or A WOCBP who agrees to follow the contraceptive guidance from at least 28 days prior to first dose of study treatment and for at least 28 days after the last dose of study treatment.\n * Capable of giving signed informed consent.\n * In France, a subject will be eligible for inclusion in this study if he or she is either affiliated to or beneficiary of a social security category.\n\n","\n\n * Planned living-related or living-unrelated kidney transplant within 52 weeks after randomization (Day 1).\n * Ferritin: <=100 nanograms/milliliter (<=100 micrograms/liter), at screening.\n * Transferrin saturation (TSAT): <=20 percent, at screening. If TSAT is 18 to 20 percent, then a retest using a new blood sample can be obtained within 7 days of the final laboratory report; the final retest value must be >20 percent to confirm eligibility.\n * Aplasias: History of bone marrow aplasia or pure red cell aplasia.\n * Conditions, other than anemia of CKD, which can affect erythropoiesis.\n * Myocardial infarction (MI) or acute coronary syndrome within 8 weeks prior to screening through to randomization (Day 1).\n * Stroke or transient ischemic attack within 8 weeks prior to screening through to randomization (Day 1).\n * Heart failure (HF): Chronic Class IV HF, as defined by the New York Heart Association (NYHA) functional classification system.\n * Current uncontrolled hypertension as determined by the investigator that would contraindicate the use of rhEPO.\n * Bazett's correction of QTc interval (QTcB): at Day 1: QTcB >500 milliseconds, or QTcB >530 milliseconds in subjects with bundle branch block. There is no QTc (corrected QT) exclusion for subjects with a predominantly ventricular paced rhythm.\n * Liver Disease: presence of any one of the following liver-related laboratory values or conditions, at screening, is exclusionary: ALT >2x upper limit of normal (ULN); Bilirubin >1.5x ULN; or Current unstable liver or biliary disease per investigator assessment, generally defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis.\n * Evidence of actively bleeding gastric, duodenal or esophageal ulcer disease OR clinically significant gastro intestinal bleeding <= 8 weeks prior to screening through to randomization (Day 1).\n * History of malignancy within 2 years prior to screening through to randomization (Day 1), currently receiving treatment for cancer, or complex kidney cyst (e.g., Bosniak Category IIF, III or IV) >3 centimeters.\n * Use of a strong inhibitor of Cytochrome P4502C8 [CYP2C8] (e.g. gemfibrozil) or a strong inducer of CYP2C8 (e.g. rifampin/rifampicin).\n * History of severe allergic or anaphylactic reactions or hypersensitivity to excipients in the investigational product (daprodustat) or epoetin alfa.\n * Use of another investigational agent within 30 days or within five half-lives of the investigational agent (whichever is longer) or currently participating in a study of an investigational device prior to screening through to randomization (Day 1).\n * Any prior treatment with daprodustat for treatment duration of >30 days.\n * Any other condition, clinical or laboratory abnormality, or examination finding that the investigator considers would put the subject at unacceptable risk, which may affect study compliance (e.g. intolerance to rhEPO) or prevent understanding of the aims or investigational procedures or possible consequences of the study.",{"$nulls":4},"Actual","2018-01-17","Actual","Anticipated","2020-07-08","Anticipated","2020-01-01","2018-01-08","2018-01-08","2020-01-31","Yes","CKD, EPO, rhEPO, Hemodialysis dependent, Daprodustat","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years","99 Years","All",null,"No","Yes\nIPD for this study will be made available via the Clinical Study Data Request site.",{"$nulls":3},"Yes","No",{"$nulls":17},"2017-004372-56","EudraCT Number","Mean change in Hemoglobin (Hgb) between Baseline and over Evaluation period [EP] (Weeks 28 to 52)","Blood samples will be collected from subjects for Hgb measurements.","Baseline and up to Week 52","Mean monthly intravenous (IV) iron dose per subject up to Week 52|Number of subjects with adverse events (AEs), serious adverse events (SAEs), adverse event of special interest (AESI) and MACE|Percentage of time Hgb will be in the analysis range (10 to 11.5 grams/deciliter) over EP (Weeks 28 to 52)|Time to stopping study treatment due to meeting rescue criteria|Number of responders in the Hgb analysis range over EP (Weeks 28 to 52)|Change from Baseline in SBP, DBP and mean arterial pressure (MAP) at Week 52 and at the end of study treatment|Number of BP exacerbation events per 100 subject years|Number of subjects with at least one BP exacerbation event during the study|Pre-dose trough concentration (Ctau) of daprodustat|Pre-dose Ctau of metabolites M2|Pre-dose Ctau of metabolites M4|Pre-dose Ctau of metabolites M3|Pre-dose Ctau of metabolites M5|Pre-dose Ctau of metabolites M6|Pre-dose Ctau of metabolites M13|Maximum observed concentration (Cmax) of daprodustat|Cmax of metabolites M2|Cmax of metabolites M3|Cmax of metabolites M4|Cmax of metabolites M5|Cmax of metabolites M6|Cmax of metabolites M13|Change from Baseline in Patient Global Impression of Severity (PGI-S) score|Absolute values over time for composite of hematology parameters as a measure of safety|Changes from baseline over time in composite of hematology parameters as a measure of safety|Absolute values over time for composite of chemistry parameters as a measure of safety|Changes from baseline over time in composite of chemistry parameters as a measure of safety|Absolute values of systolic and diastolic blood pressure as a measure of safety|Change from Baseline in systolic and diastolic blood pressure as a measure of safety|Absolute values for heart rate as a measure of safety|Change from Baseline in Heart rate as a measure of safety","IV iron use for all subjects will be recorded in the electronic case record form (eCRF) and the average monthly IV iron dose up to Week 52 while on treatment will be calculated.|AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is medically significant. Along with AE and SAE the study will also assess AESI and MACE events until follow-up Week 52.|Subjects will be treated to achieve and maintain Hgb between 10 and 11.5 grams/deciliter. The study treatment may be dose-titrated, if needed, during EP to achieve or maintain Hgb level in the target range.|A rescue algorithm is provided to minimize subjects having an inadequate response to the treatment for their anemia for an extended period of time and to enable consistency in the application of rescue therapy across the study. The time to stopping of study treatment due to subjects meeting the rescue criteria will be assessed. The date and time of rescue medication administration as well as the name and dosage regimen of the rescue medication must be recorded.|A responder is defined as a subject with mean Hgb within the Hgb analysis range 10 to 11.5 grams/deciliter during the EP. Subjects will be treated to achieve and maintain Hgb between 10 and 11.5 grams/deciliter. The study treatment may be dose-titrated, if needed, during EP to achieve or maintain Hgb level in the target range.|MAP is an average BP in an individual during a single cardiac cycle. Measurements will be taken both pre-dialysis and post-dialysis. Measurements will be taken with the subject is in a semi-supine or seated position in the dialysis chair after at least a 5-minute rest period, pre- and post-dialysis. Measurement of SBP, DBP and MAP will be performed before collection of blood samples for laboratory testing, where applicable.|The calculation of events per subject-years is the number of incident cases divided by the amount of subjects-time at risk. Number of BP exacerbation events per 100 subject years will be calculated.|Number of subjects with at least 1 BP exacerbation event up to Week 52 will be calculated.|Blood samples (6 in total) will be collected at the Day 1 visit pre-dose and at any one post-Baseline visit between Week 8 and Week 52.|Change from Baseline in global symptom severity will be assessed. Symptom severity will be assessed using the PGI-S. The PGI-S is a 1-item questionnaire designed to assess subjects impression of disease severity of their anemia of CKD.|The following hematology parameters will be measured: Hemoglobin, Hematocrit, RBC count, Mean corpuscular volume (MCV), Mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), Red cell distribution width (RDW), Reticulocyte count, Platelet count, white blood cell (WBC) count, Total neutrophils, Eosinophils, Monocytes, Basophils, and Lymphocytes|The following chemistry parameters will be measured: Potassium, Albumin, Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Calcium, Phosphate, Total and direct/indirect bilirubin, and urea (serum).|Measurements will be taken both pre-dialysis and post-dialysis. Measurements will be taken with the subject is in a semi-supine or seated position in the dialysis chair after at least a 5-minute rest period, pre and post-dialysis. Measurement of SBP and DBP will be performed before collection of blood samples for laboratory testing, where applicable.|Measurements will be taken both pre-dialysis and post-dialysis. Measurements will be taken with the subject is in a semi-supine or seated position in the dialysis chair after at least a 5-minute rest period, pre and post-dialysis. Measurement of heart rate will be performed before collection of blood samples for laboratory testing, where applicable.","Up to Week 52|Weeks 28 to 52|Baseline and Week 52|Pre-dose at any one post-Baseline visit between Week 8 and Week 52|Pre-dose and 0.5, 1, 2, 3 hours|Pre-dose and 0.5, 1, 2, 3 hours post-dose|Baseline and up to Week 52",{"$nulls":3},"Mar Del Plata, Buenos Aires, Argentina, 7600 Gsk Investigational SitePergamino, Buenos Aires, Argentina, B2700Cpm Gsk Investigational SiteSarandi, Buenos Aires, Argentina, B1872Eeb|Rosario, Santa Fe, Argentina, 2000|Heidelberg, Victoria, Australia, 3084 Gsk Investigational SiteParkville, Victoria, Australia, 3050|Belo Horizonte, Minas Gerais, Brazil, 30150-221 Gsk Investigational SiteFeira De Santana, Brazil, 44001-465 Gsk Investigational SiteSÃ£o Paulo, Brazil, 04039-000|Curitiba, ParanÃ¡, Brazil, 80440-020|Passo Fundo, Rio Grande Do Sul, Brazil, 99010-080 Gsk Investigational SitePorto Alegre, Rio Grande Do Sul, Brazil, 90610-000|Sao Jose Do Rio Preto, SÃ£o Paulo, Brazil, 15090-000|Oshawa, Ontario, Canada, L1G 2B9|Bayonne, France, 64109 Gsk Investigational SiteEpagny Metz-Tessy, France, 74370 Gsk Investigational SiteLe Mans, France, 72037 Gsk Investigational SiteNice Cedex 1, France, 06001 Gsk Investigational SiteStrasbourg, France, 67000|Bologna, Emilia-Romagna, Italy, 40138 Gsk Investigational SiteModena, Emilia-Romagna, Italy, 41124|Pavia, Lombardia, Italy, 27100|Verona, Veneto, Italy, 37126 Korea, Republic Of Gsk Investigational SiteAnyang-Si, Gyeonggi-Do, Korea, Republic Of, 14068 Gsk Investigational SiteBusan, Korea, Republic Of, 49201 Gsk Investigational SiteGoyang-Si, Gyeonggi-Do, Korea, Republic Of, 10326 Gsk Investigational SiteIncheon, Korea, Republic Of, 405-760 Gsk Investigational SiteSeoul, Korea, Republic Of, 07061 Gsk Investigational SiteSeoul, Korea, Republic Of, 134-727 Gsk Investigational SiteSeoul, Korea, Republic Of, 07441|Katowice, Poland, 40-027 Gsk Investigational SiteLodz, Poland, 92-213 Gsk Investigational SiteSandomierz, Poland, 27-600 Gsk Investigational SiteTarnowskie Gory, Poland, 42-612 Gsk Investigational SiteZyrardow, Poland, 96-300|Constanta, Romania, 900591 Gsk Investigational SiteResita, Romania, 320166 Russian Federation Gsk Investigational SiteKazan, Russian Federation, 420012 Gsk Investigational SiteKolomna, Russian Federation, 140402 Gsk Investigational SiteKrasnodar, Russian Federation, 350029 Gsk Investigational SiteKrasnogorsk, Russian Federation, 143400 Gsk Investigational SiteMytischi, Russian Federation, 141009 Gsk Investigational SiteNovorossiysk, Russian Federation, 353915 Gsk Investigational SiteNovosibirsk, Russian Federation, 630087 Gsk Investigational SiteOmsk, Russian Federation, 644111 Gsk Investigational SiteOrenburg, Russian Federation, 460040 Gsk Investigational SitePenza, Russian Federation, 440034 Gsk Investigational SitePodolsk, Russian Federation, 142110 Gsk Investigational SiteSaint-Petersburg, Russian Federation, 194354 Gsk Investigational SiteSaint-Petersburg, Russian Federation, 197374 Gsk Investigational SiteSt-Petersburg, Russian Federation, 197110 Gsk Investigational SiteSt. Petersburg, Russian Federation, 193318 Gsk Investigational SiteSt. Petersburg, Russian Federation, 194104 Gsk Investigational SiteSt. Petersburg, Russian Federation, 196247 Gsk Investigational SiteUfa, Russian Federation, 450071 Gsk Investigational SiteYaroslavl, Russian Federation, 150062|Almeria, Spain, 04009 Gsk Investigational SiteBadalona, Spain, 08916 Gsk Investigational SiteBarcelona, Spain, 08036 Gsk Investigational SiteGerona, Spain, 17007 Gsk Investigational SiteGranollers, Barcelona, Spain, 08041 Gsk Investigational SiteMadrid, Spain, 28100 Gsk Investigational SiteManises (Valencia), Spain, 46940 Gsk Investigational SiteSan SebastiÃ¡n De Los Reyes/Madrid, Spain Gsk Investigational SiteSanlÃºcar De Barrameda (CÃ¡diz), Spain, 11540|Bradford, United Kingdom, Bd5 0Na Gsk Investigational SiteLondon, United Kingdom, Se5 9Rs Gsk Investigational SiteSheffield, United Kingdom, S5 7Au Gsk Investigational SiteSwansea, United Kingdom, Sa6 6Nl|Mesa, Arizona, United States, 85210|Fresno, California, United States, 93720 Gsk Investigational SiteLos Angeles, California, United States, 90025 Gsk Investigational SiteParamount, California, United States, 90723|Middlebury, Connecticut, United States, 06762|Hollywood, Florida, United States, 33024 Gsk Investigational SiteMiami, Florida, United States, 33169 Gsk Investigational SiteTampa, Florida, United States, 33614|Macon, Georgia, United States, 31201|Meridian, Idaho, United States, 83642|Pittsfield, Massachusetts, United States, 01201|Kansas City, Missouri, United States, 64111 Gsk Investigational SiteSaint Louis, Missouri, United States, 63110|Albuquerque, New|College Point, New York, United States, 11356|Winston-Salem, North Carolina, United States, 27157|Oklahoma City, Oklahoma, United States, 73116|Houston, Texas, United States, 77004 Gsk Investigational SiteHouston, Texas, United States, 77099 Gsk Investigational SiteLufkin, Texas, United States, 75904|Alexandria, Virginia, United States, 22304 Gsk Investigational SiteHampton, Virginia, United States, 23666 Gsk Investigational SiteNorfolk, Virginia, United States, 23510","Arizona|California|Connecticut|Florida|Georgia|Idaho|Massachusetts|Missouri|New Mexico|New York|North Carolina|Oklahoma|Texas|Virginia","Argentina|Australia|Brazil|Canada|France|Italy|Poland|Romania|Spain|United Kingdom|United States","Buenos Aires Gsk Investigational Site|Santa Fe Gsk Investigational Site|Victoria Gsk Investigational Site|Gsk Investigational Site|ParanÃ¡ Gsk Investigational Site|Rio Grande Do Sul Gsk Investigational Site|SÃ£o Paulo Gsk Investigational Site|Ontario Gsk Investigational Site|Emilia-Romagna Gsk Investigational Site|Lombardia Gsk Investigational Site|Veneto Gsk Investigational Site",{"$nulls":3},"GSK Clinical Trials","2020-01-31","2020-05-25T16:36:57.466","2020-05-26T17:10:42.972","NCT03400033"]
["5ecbf429feab101b1553089a","NCT03400033","2020-03-13","GlaxoSmithKline","GSK","Active, not recruiting","Anemia Studies in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat-Three-times Weekly Dosing in Dialysis (ASCEND-TD)","Daprodustat|Epoetin alfa","HIF Inhibitor|ESA Activator","Yes","['Daprodustat']","Yes","['HIF Inhibitor']","Phase 3",2,407,"Actual","2018-09-05","2020-07-08",{"$nulls":5},"This Phase 3 study in hemodialysis-dependent subjects with anemia will evaluate the efficacy and safety of daprodustat administered three-times weekly compared to epoetin alfa, the current standard of care. This study includes a 4 week Screening Period, a 52 week Treatment Period and a 4 to 6 week follow-up period. Each subject will remain in the study for up to 62 weeks. Approximately 402 subjects will be randomized to receive either daprodustat three times weekly or epoetin alfa three-times weekly or once weekly, depending on dose level.",null,"A Phase 3 Randomized, Double-blind, Active-controlled, Parallel-group, Multi-center Study in Hemodialysis Participants With Anemia of Chronic Kidney Disease to Evaluate the Efficacy, Safety and Pharmacokinetics of Three-times Weekly Dosing of Daprodustat Compared to Recombinant Human Erythropoietin, Following a Switch From Recombinant Human Erythropoietin or Its Analogs",204837,"Anaemia","Anemia","Hematologic Diseases","Heme & Lymph Diseases","Experimental|Active Comparator","Daprodustat|Epoetin alfa","Subjects randomized to this arm will receive daprodustat tablets titrated doses from 2 to 48 milligrams orally three-times weekly along with saline by IV route for the 52 weeks treatment period.|Subjects randomized to this arm will receive matching placebo tablets to daprodustat orally three-times weekly and Epoetin alfa by IV route for the 52 weeks treatment period.","Drug","Daprodustat tablets|Saline vials or bags|Matching placebo tablets|Epoetin alfa vials","Round, biconvex, white, film-coated tablet in unit dose strengths 2 and 4 milligrams (7 millimeter tablets), 6, 8 and 10 milligrams (9 millimeter tablets) administered by the oral route.|0.9% sodium chloride saline vials or bags administered by the IV route.|Matching placebo to daprodustat tablets supplied as round, biconvex, white, film-coated tablet in unit dose strengths 2 and 4 milligrams (7 millimeter tablets), 6, 8 and 10 milligrams (9 millimeter tablets) administered by the oral route.|Single-dose, preservative-free vials in unit dose strengths of 2000, 3000, 4000 and 10,000 Units/milliliter administered by the IV route.",null,"Daprodustat|Epoetin alfa","\n\n * Subject must be 18 to 99 years of age inclusive, at the time of signing the informed consent.\n * Use of any approved rhEPO or analog for at least 8 weeks prior to the screening visit and continuing during the screening period until randomization (Day 1).\n * Hgb concentration (measured by HemoCue) within the following range: Week -4: Hgb 8 to 11.5 grams/deciliter (5 to 7.1 millimoles/liter). If Hgb is 11.6 to 11.9 grams/deciliter (7.2 to 7.4 millimoles/liter), up to two retests are allowed; the retest value must be between 8 to 11.5 grams/deciliter (5 to 7.1 millimoles/liter). Day 1: Hgb 8 to 11 grams/deciliter (5 to 6.8 millimoles/liter) and receiving at least the minimum rhEPO or analog dose 3. Hgb>11 to 11.5 grams/deciliter (6.8 to 7.1 millimoles/liter) and receiving greater than the minimum rhEPO or analog dose 3.\n * On hemodialysis (including hemofiltration or hemodiafiltration) >90 days prior to screening and continuing during the screening period.\n * On hemodialysis (in-center) >=3 times per week.\n * Male and female subjects are eligible. A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: Not a woman of childbearing potential (WOCBP), or A WOCBP who agrees to follow the contraceptive guidance from at least 28 days prior to first dose of study treatment and for at least 28 days after the last dose of study treatment.\n * Capable of giving signed informed consent.\n * In France, a subject will be eligible for inclusion in this study if he or she is either affiliated to or beneficiary of a social security category.\n\n","\n\n * Planned living-related or living-unrelated kidney transplant within 52 weeks after randomization (Day 1).\n * Ferritin: <=100 nanograms/milliliter (<=100 micrograms/liter), at screening.\n * Transferrin saturation (TSAT): <=20 percent, at screening. If TSAT is 18 to 20 percent, then a retest using a new blood sample can be obtained within 7 days of the final laboratory report; the final retest value must be >20 percent to confirm eligibility.\n * Aplasias: History of bone marrow aplasia or pure red cell aplasia.\n * Conditions, other than anemia of CKD, which can affect erythropoiesis.\n * Myocardial infarction (MI) or acute coronary syndrome within 8 weeks prior to screening through to randomization (Day 1).\n * Stroke or transient ischemic attack within 8 weeks prior to screening through to randomization (Day 1).\n * Heart failure (HF): Chronic Class IV HF, as defined by the New York Heart Association (NYHA) functional classification system.\n * Current uncontrolled hypertension as determined by the investigator that would contraindicate the use of rhEPO.\n * Bazett's correction of QTc interval (QTcB): at Day 1: QTcB >500 milliseconds, or QTcB >530 milliseconds in subjects with bundle branch block. There is no QTc (corrected QT) exclusion for subjects with a predominantly ventricular paced rhythm.\n * Liver Disease: presence of any one of the following liver-related laboratory values or conditions, at screening, is exclusionary: ALT >2x upper limit of normal (ULN); Bilirubin >1.5x ULN; or Current unstable liver or biliary disease per investigator assessment, generally defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis.\n * Evidence of actively bleeding gastric, duodenal or esophageal ulcer disease OR clinically significant gastro intestinal bleeding <= 8 weeks prior to screening through to randomization (Day 1).\n * History of malignancy within 2 years prior to screening through to randomization (Day 1), currently receiving treatment for cancer, or complex kidney cyst (e.g., Bosniak Category IIF, III or IV) >3 centimeters.\n * Use of a strong inhibitor of Cytochrome P4502C8 [CYP2C8] (e.g. gemfibrozil) or a strong inducer of CYP2C8 (e.g. rifampin/rifampicin).\n * History of severe allergic or anaphylactic reactions or hypersensitivity to excipients in the investigational product (daprodustat) or epoetin alfa.\n * Use of another investigational agent within 30 days or within five half-lives of the investigational agent (whichever is longer) or currently participating in a study of an investigational device prior to screening through to randomization (Day 1).\n * Any prior treatment with daprodustat for treatment duration of >30 days.\n * Any other condition, clinical or laboratory abnormality, or examination finding that the investigator considers would put the subject at unacceptable risk, which may affect study compliance (e.g. intolerance to rhEPO) or prevent understanding of the aims or investigational procedures or possible consequences of the study.",{"$nulls":4},"Actual","2018-01-17","Actual","Anticipated","2020-07-08","Anticipated","2020-03-01","2018-01-08","2018-01-08","2020-03-12","Yes","CKD, EPO, rhEPO, Hemodialysis dependent, Daprodustat","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years","99 Years","All",null,"No","Yes\nIPD for this study will be made available via the Clinical Study Data Request site.",{"$nulls":3},"Yes","No",{"$nulls":17},"2017-004372-56","EudraCT Number","Mean change in Hemoglobin (Hgb) between Baseline and over Evaluation period [EP] (Weeks 28 to 52)","Blood samples will be collected from subjects for Hgb measurements.","Baseline and up to Week 52","Mean monthly intravenous (IV) iron dose per subject up to Week 52|Number of subjects with adverse events (AEs), serious adverse events (SAEs), adverse event of special interest (AESI) and MACE|Percentage of time Hgb will be in the analysis range (10 to 11.5 grams/deciliter) over EP (Weeks 28 to 52)|Time to stopping study treatment due to meeting rescue criteria|Number of responders in the Hgb analysis range over EP (Weeks 28 to 52)|Change from Baseline in SBP, DBP and mean arterial pressure (MAP) at Week 52 and at the end of study treatment|Number of BP exacerbation events per 100 subject years|Number of subjects with at least one BP exacerbation event during the study|Pre-dose trough concentration (Ctau) of daprodustat|Pre-dose Ctau of metabolites M2|Pre-dose Ctau of metabolites M4|Pre-dose Ctau of metabolites M3|Pre-dose Ctau of metabolites M5|Pre-dose Ctau of metabolites M6|Pre-dose Ctau of metabolites M13|Maximum observed concentration (Cmax) of daprodustat|Cmax of metabolites M2|Cmax of metabolites M3|Cmax of metabolites M4|Cmax of metabolites M5|Cmax of metabolites M6|Cmax of metabolites M13|Change from Baseline in Patient Global Impression of Severity (PGI-S) score|Absolute values over time for composite of hematology parameters as a measure of safety|Changes from baseline over time in composite of hematology parameters as a measure of safety|Absolute values over time for composite of chemistry parameters as a measure of safety|Changes from baseline over time in composite of chemistry parameters as a measure of safety|Absolute values of systolic and diastolic blood pressure as a measure of safety|Change from Baseline in systolic and diastolic blood pressure as a measure of safety|Absolute values for heart rate as a measure of safety|Change from Baseline in Heart rate as a measure of safety","IV iron use for all subjects will be recorded in the electronic case record form (eCRF) and the average monthly IV iron dose up to Week 52 while on treatment will be calculated.|AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is medically significant. Along with AE and SAE the study will also assess AESI and MACE events until follow-up Week 52.|Subjects will be treated to achieve and maintain Hgb between 10 and 11.5 grams/deciliter. The study treatment may be dose-titrated, if needed, during EP to achieve or maintain Hgb level in the target range.|A rescue algorithm is provided to minimize subjects having an inadequate response to the treatment for their anemia for an extended period of time and to enable consistency in the application of rescue therapy across the study. The time to stopping of study treatment due to subjects meeting the rescue criteria will be assessed. The date and time of rescue medication administration as well as the name and dosage regimen of the rescue medication must be recorded.|A responder is defined as a subject with mean Hgb within the Hgb analysis range 10 to 11.5 grams/deciliter during the EP. Subjects will be treated to achieve and maintain Hgb between 10 and 11.5 grams/deciliter. The study treatment may be dose-titrated, if needed, during EP to achieve or maintain Hgb level in the target range.|MAP is an average BP in an individual during a single cardiac cycle. Measurements will be taken both pre-dialysis and post-dialysis. Measurements will be taken with the subject is in a semi-supine or seated position in the dialysis chair after at least a 5-minute rest period, pre- and post-dialysis. Measurement of SBP, DBP and MAP will be performed before collection of blood samples for laboratory testing, where applicable.|The calculation of events per subject-years is the number of incident cases divided by the amount of subjects-time at risk. Number of BP exacerbation events per 100 subject years will be calculated.|Number of subjects with at least 1 BP exacerbation event up to Week 52 will be calculated.|Blood samples (6 in total) will be collected at the Day 1 visit pre-dose and at any one post-Baseline visit between Week 8 and Week 52.|Change from Baseline in global symptom severity will be assessed. Symptom severity will be assessed using the PGI-S. The PGI-S is a 1-item questionnaire designed to assess subjects impression of disease severity of their anemia of CKD.|The following hematology parameters will be measured: Hemoglobin, Hematocrit, RBC count, Mean corpuscular volume (MCV), Mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), Red cell distribution width (RDW), Reticulocyte count, Platelet count, white blood cell (WBC) count, Total neutrophils, Eosinophils, Monocytes, Basophils, and Lymphocytes|The following chemistry parameters will be measured: Potassium, Albumin, Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Calcium, Phosphate, Total and direct/indirect bilirubin, and urea (serum).|Measurements will be taken both pre-dialysis and post-dialysis. Measurements will be taken with the subject is in a semi-supine or seated position in the dialysis chair after at least a 5-minute rest period, pre and post-dialysis. Measurement of SBP and DBP will be performed before collection of blood samples for laboratory testing, where applicable.|Measurements will be taken both pre-dialysis and post-dialysis. Measurements will be taken with the subject is in a semi-supine or seated position in the dialysis chair after at least a 5-minute rest period, pre and post-dialysis. Measurement of heart rate will be performed before collection of blood samples for laboratory testing, where applicable.","Up to Week 52|Weeks 28 to 52|Baseline and Week 52|Pre-dose at any one post-Baseline visit between Week 8 and Week 52|Pre-dose and 0.5, 1, 2, 3 hours|Pre-dose and 0.5, 1, 2, 3 hours post-dose|Baseline and up to Week 52",{"$nulls":3},"Mar Del Plata, Buenos Aires, Argentina, 7600 Gsk Investigational SitePergamino, Buenos Aires, Argentina, B2700Cpm Gsk Investigational SiteSarandi, Buenos Aires, Argentina, B1872Eeb|Rosario, Santa Fe, Argentina, 2000|Heidelberg, Victoria, Australia, 3084 Gsk Investigational SiteParkville, Victoria, Australia, 3050|Belo Horizonte, Minas Gerais, Brazil, 30150-221 Gsk Investigational SiteFeira De Santana, Brazil, 44001-465 Gsk Investigational SiteSÃ£o Paulo, Brazil, 04039-000|Curitiba, ParanÃ¡, Brazil, 80440-020|Passo Fundo, Rio Grande Do Sul, Brazil, 99010-080 Gsk Investigational SitePorto Alegre, Rio Grande Do Sul, Brazil, 90610-000|Sao Jose Do Rio Preto, SÃ£o Paulo, Brazil, 15090-000|Oshawa, Ontario, Canada, L1G 2B9|Bayonne, France, 64109 Gsk Investigational SiteEpagny Metz-Tessy, France, 74370 Gsk Investigational SiteLe Mans, France, 72037 Gsk Investigational SiteNice Cedex 1, France, 06001 Gsk Investigational SiteStrasbourg, France, 67000|Bologna, Emilia-Romagna, Italy, 40138 Gsk Investigational SiteModena, Emilia-Romagna, Italy, 41124|Pavia, Lombardia, Italy, 27100|Verona, Veneto, Italy, 37126 Korea, Republic Of Gsk Investigational SiteAnyang-Si, Gyeonggi-Do, Korea, Republic Of, 14068 Gsk Investigational SiteBusan, Korea, Republic Of, 49201 Gsk Investigational SiteGoyang-Si, Gyeonggi-Do, Korea, Republic Of, 10326 Gsk Investigational SiteIncheon, Korea, Republic Of, 405-760 Gsk Investigational SiteSeoul, Korea, Republic Of, 07061 Gsk Investigational SiteSeoul, Korea, Republic Of, 134-727 Gsk Investigational SiteSeoul, Korea, Republic Of, 07441|Katowice, Poland, 40-027 Gsk Investigational SiteLodz, Poland, 92-213 Gsk Investigational SiteSandomierz, Poland, 27-600 Gsk Investigational SiteTarnowskie Gory, Poland, 42-612 Gsk Investigational SiteZyrardow, Poland, 96-300|Constanta, Romania, 900591 Gsk Investigational SiteResita, Romania, 320166 Russian Federation Gsk Investigational SiteKazan, Russian Federation, 420012 Gsk Investigational SiteKolomna, Russian Federation, 140402 Gsk Investigational SiteKrasnodar, Russian Federation, 350029 Gsk Investigational SiteKrasnogorsk, Russian Federation, 143400 Gsk Investigational SiteMytischi, Russian Federation, 141009 Gsk Investigational SiteNovorossiysk, Russian Federation, 353915 Gsk Investigational SiteNovosibirsk, Russian Federation, 630087 Gsk Investigational SiteOmsk, Russian Federation, 644111 Gsk Investigational SiteOrenburg, Russian Federation, 460040 Gsk Investigational SitePenza, Russian Federation, 440034 Gsk Investigational SitePodolsk, Russian Federation, 142110 Gsk Investigational SiteSaint-Petersburg, Russian Federation, 194354 Gsk Investigational SiteSaint-Petersburg, Russian Federation, 197374 Gsk Investigational SiteSt-Petersburg, Russian Federation, 197110 Gsk Investigational SiteSt. Petersburg, Russian Federation, 193318 Gsk Investigational SiteSt. Petersburg, Russian Federation, 194104 Gsk Investigational SiteSt. Petersburg, Russian Federation, 196247 Gsk Investigational SiteUfa, Russian Federation, 450071 Gsk Investigational SiteYaroslavl, Russian Federation, 150062|Almeria, Spain, 04009 Gsk Investigational SiteBadalona, Spain, 08916 Gsk Investigational SiteBarcelona, Spain, 08036 Gsk Investigational SiteGerona, Spain, 17007 Gsk Investigational SiteGranollers, Barcelona, Spain, 08041 Gsk Investigational SiteMadrid, Spain, 28100 Gsk Investigational SiteManises (Valencia), Spain, 46940 Gsk Investigational SiteSanlÃºcar De Barrameda (CÃ¡diz), Spain, 11540|Bradford, United Kingdom, Bd5 0Na Gsk Investigational SiteLondon, United Kingdom, Se5 9Rs Gsk Investigational SiteSheffield, United Kingdom, S5 7Au Gsk Investigational SiteSwansea, United Kingdom, Sa6 6Nl|Mesa, Arizona, United States, 85210|Fresno, California, United States, 93720 Gsk Investigational SiteLos Angeles, California, United States, 90025 Gsk Investigational SiteParamount, California, United States, 90723|Middlebury, Connecticut, United States, 06762|Hollywood, Florida, United States, 33024 Gsk Investigational SiteMiami, Florida, United States, 33169 Gsk Investigational SiteTampa, Florida, United States, 33614|Macon, Georgia, United States, 31201|Meridian, Idaho, United States, 83642|Pittsfield, Massachusetts, United States, 01201|Kansas City, Missouri, United States, 64111 Gsk Investigational SiteSaint Louis, Missouri, United States, 63110|Albuquerque, New|College Point, New York, United States, 11356|Winston-Salem, North Carolina, United States, 27157|Oklahoma City, Oklahoma, United States, 73116|Houston, Texas, United States, 77004 Gsk Investigational SiteHouston, Texas, United States, 77099 Gsk Investigational SiteLufkin, Texas, United States, 75904|Alexandria, Virginia, United States, 22304 Gsk Investigational SiteHampton, Virginia, United States, 23666 Gsk Investigational SiteNorfolk, Virginia, United States, 23510","Arizona|California|Connecticut|Florida|Georgia|Idaho|Massachusetts|Missouri|New Mexico|New York|North Carolina|Oklahoma|Texas|Virginia","Argentina|Australia|Brazil|Canada|France|Italy|Poland|Romania|Spain|United Kingdom|United States","Buenos Aires Gsk Investigational Site|Santa Fe Gsk Investigational Site|Victoria Gsk Investigational Site|Gsk Investigational Site|ParanÃ¡ Gsk Investigational Site|Rio Grande Do Sul Gsk Investigational Site|SÃ£o Paulo Gsk Investigational Site|Ontario Gsk Investigational Site|Emilia-Romagna Gsk Investigational Site|Lombardia Gsk Investigational Site|Veneto Gsk Investigational Site",{"$nulls":3},"GSK Clinical Trials","2020-03-12","2020-05-25T16:36:57.862","2020-05-26T17:10:42.972","NCT03400033"]
["5ecbf429fe30261b1a04826a","NCT03400033","2020-03-23","GlaxoSmithKline","GSK","Active, not recruiting","Anemia Studies in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat-Three-times Weekly Dosing in Dialysis (ASCEND-TD)","Daprodustat|Epoetin alfa","HIF Inhibitor|ESA Activator","Yes","['Daprodustat']","Yes","['HIF Inhibitor']","Phase 3",2,407,"Actual","2018-09-05","2020-07-08",{"$nulls":5},"This Phase 3 study in hemodialysis-dependent subjects with anemia will evaluate the efficacy and safety of daprodustat administered three-times weekly compared to epoetin alfa, the current standard of care. This study includes a 4 week Screening Period, a 52 week Treatment Period and a 4 to 6 week follow-up period. Each subject will remain in the study for up to 62 weeks. Approximately 402 subjects will be randomized to receive either daprodustat three times weekly or epoetin alfa three-times weekly or once weekly, depending on dose level.",null,"A Phase 3 Randomized, Double-blind, Active-controlled, Parallel-group, Multi-center Study in Hemodialysis Participants With Anemia of Chronic Kidney Disease to Evaluate the Efficacy, Safety and Pharmacokinetics of Three-times Weekly Dosing of Daprodustat Compared to Recombinant Human Erythropoietin, Following a Switch From Recombinant Human Erythropoietin or Its Analogs",204837,"Anaemia","Anemia","Hematologic Diseases","Heme & Lymph Diseases","Experimental|Active Comparator","Daprodustat|Epoetin alfa","Subjects randomized to this arm will receive daprodustat tablets titrated doses from 2 to 48 milligrams orally three-times weekly along with saline by IV route for the 52 weeks treatment period.|Subjects randomized to this arm will receive matching placebo tablets to daprodustat orally three-times weekly and Epoetin alfa by IV route for the 52 weeks treatment period.","Drug","Daprodustat tablets|Saline vials or bags|Matching placebo tablets|Epoetin alfa vials","Round, biconvex, white, film-coated tablet in unit dose strengths 2 and 4 milligrams (7 millimeter tablets), 6, 8 and 10 milligrams (9 millimeter tablets) administered by the oral route.|0.9% sodium chloride saline vials or bags administered by the IV route.|Matching placebo to daprodustat tablets supplied as round, biconvex, white, film-coated tablet in unit dose strengths 2 and 4 milligrams (7 millimeter tablets), 6, 8 and 10 milligrams (9 millimeter tablets) administered by the oral route.|Single-dose, preservative-free vials in unit dose strengths of 2000, 3000, 4000 and 10,000 Units/milliliter administered by the IV route.",null,"Daprodustat|Epoetin alfa","\n\n * Subject must be 18 to 99 years of age inclusive, at the time of signing the informed consent.\n * Use of any approved rhEPO or analog for at least 8 weeks prior to the screening visit and continuing during the screening period until randomization (Day 1).\n * Hgb concentration (measured by HemoCue) within the following range: Week -4: Hgb 8 to 11.5 grams/deciliter (5 to 7.1 millimoles/liter). If Hgb is 11.6 to 11.9 grams/deciliter (7.2 to 7.4 millimoles/liter), up to two retests are allowed; the retest value must be between 8 to 11.5 grams/deciliter (5 to 7.1 millimoles/liter). Day 1: Hgb 8 to 11 grams/deciliter (5 to 6.8 millimoles/liter) and receiving at least the minimum rhEPO or analog dose 3. Hgb>11 to 11.5 grams/deciliter (6.8 to 7.1 millimoles/liter) and receiving greater than the minimum rhEPO or analog dose 3.\n * On hemodialysis (including hemofiltration or hemodiafiltration) >90 days prior to screening and continuing during the screening period.\n * On hemodialysis (in-center) >=3 times per week.\n * Male and female subjects are eligible. A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: Not a woman of childbearing potential (WOCBP), or A WOCBP who agrees to follow the contraceptive guidance from at least 28 days prior to first dose of study treatment and for at least 28 days after the last dose of study treatment.\n * Capable of giving signed informed consent.\n * In France, a subject will be eligible for inclusion in this study if he or she is either affiliated to or beneficiary of a social security category.\n\n","\n\n * Planned living-related or living-unrelated kidney transplant within 52 weeks after randomization (Day 1).\n * Ferritin: <=100 nanograms/milliliter (<=100 micrograms/liter), at screening.\n * Transferrin saturation (TSAT): <=20 percent, at screening. If TSAT is 18 to 20 percent, then a retest using a new blood sample can be obtained within 7 days of the final laboratory report; the final retest value must be >20 percent to confirm eligibility.\n * Aplasias: History of bone marrow aplasia or pure red cell aplasia.\n * Conditions, other than anemia of CKD, which can affect erythropoiesis.\n * Myocardial infarction (MI) or acute coronary syndrome within 8 weeks prior to screening through to randomization (Day 1).\n * Stroke or transient ischemic attack within 8 weeks prior to screening through to randomization (Day 1).\n * Heart failure (HF): Chronic Class IV HF, as defined by the New York Heart Association (NYHA) functional classification system.\n * Current uncontrolled hypertension as determined by the investigator that would contraindicate the use of rhEPO.\n * Bazett's correction of QTc interval (QTcB): at Day 1: QTcB >500 milliseconds, or QTcB >530 milliseconds in subjects with bundle branch block. There is no QTc (corrected QT) exclusion for subjects with a predominantly ventricular paced rhythm.\n * Liver Disease: presence of any one of the following liver-related laboratory values or conditions, at screening, is exclusionary: ALT >2x upper limit of normal (ULN); Bilirubin >1.5x ULN; or Current unstable liver or biliary disease per investigator assessment, generally defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis.\n * Evidence of actively bleeding gastric, duodenal or esophageal ulcer disease OR clinically significant gastro intestinal bleeding <= 8 weeks prior to screening through to randomization (Day 1).\n * History of malignancy within 2 years prior to screening through to randomization (Day 1), currently receiving treatment for cancer, or complex kidney cyst (e.g., Bosniak Category IIF, III or IV) >3 centimeters.\n * Use of a strong inhibitor of Cytochrome P4502C8 [CYP2C8] (e.g. gemfibrozil) or a strong inducer of CYP2C8 (e.g. rifampin/rifampicin).\n * History of severe allergic or anaphylactic reactions or hypersensitivity to excipients in the investigational product (daprodustat) or epoetin alfa.\n * Use of another investigational agent within 30 days or within five half-lives of the investigational agent (whichever is longer) or currently participating in a study of an investigational device prior to screening through to randomization (Day 1).\n * Any prior treatment with daprodustat for treatment duration of >30 days.\n * Any other condition, clinical or laboratory abnormality, or examination finding that the investigator considers would put the subject at unacceptable risk, which may affect study compliance (e.g. intolerance to rhEPO) or prevent understanding of the aims or investigational procedures or possible consequences of the study.",{"$nulls":4},"Actual","2018-01-17","Actual","Anticipated","2020-07-08","Anticipated","2020-03-01","2018-01-08","2018-01-08","2020-03-20","Yes","CKD, EPO, rhEPO, Hemodialysis dependent, Daprodustat","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years","99 Years","All",null,"No","Yes\nIPD for this study will be made available via the Clinical Study Data Request site.",{"$nulls":3},"Yes","No",{"$nulls":17},"2017-004372-56","EudraCT Number","Mean change in Hemoglobin (Hgb) between Baseline and over Evaluation period [EP] (Weeks 28 to 52)","Blood samples will be collected from subjects for Hgb measurements.","Baseline and up to Week 52","Mean monthly intravenous (IV) iron dose per subject up to Week 52|Number of subjects with adverse events (AEs), serious adverse events (SAEs), adverse event of special interest (AESI) and MACE|Percentage of time Hgb will be in the analysis range (10 to 11.5 grams/deciliter) over EP (Weeks 28 to 52)|Time to stopping study treatment due to meeting rescue criteria|Number of responders in the Hgb analysis range over EP (Weeks 28 to 52)|Change from Baseline in SBP, DBP and mean arterial pressure (MAP) at Week 52 and at the end of study treatment|Number of BP exacerbation events per 100 subject years|Number of subjects with at least one BP exacerbation event during the study|Pre-dose trough concentration (Ctau) of daprodustat|Pre-dose Ctau of metabolites M2|Pre-dose Ctau of metabolites M4|Pre-dose Ctau of metabolites M3|Pre-dose Ctau of metabolites M5|Pre-dose Ctau of metabolites M6|Pre-dose Ctau of metabolites M13|Maximum observed concentration (Cmax) of daprodustat|Cmax of metabolites M2|Cmax of metabolites M3|Cmax of metabolites M4|Cmax of metabolites M5|Cmax of metabolites M6|Cmax of metabolites M13|Change from Baseline in Patient Global Impression of Severity (PGI-S) score|Absolute values over time for composite of hematology parameters as a measure of safety|Changes from baseline over time in composite of hematology parameters as a measure of safety|Absolute values over time for composite of chemistry parameters as a measure of safety|Changes from baseline over time in composite of chemistry parameters as a measure of safety|Absolute values of systolic and diastolic blood pressure as a measure of safety|Change from Baseline in systolic and diastolic blood pressure as a measure of safety|Absolute values for heart rate as a measure of safety|Change from Baseline in Heart rate as a measure of safety","IV iron use for all subjects will be recorded in the electronic case record form (eCRF) and the average monthly IV iron dose up to Week 52 while on treatment will be calculated.|AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is medically significant. Along with AE and SAE the study will also assess AESI and MACE events until follow-up Week 52.|Subjects will be treated to achieve and maintain Hgb between 10 and 11.5 grams/deciliter. The study treatment may be dose-titrated, if needed, during EP to achieve or maintain Hgb level in the target range.|A rescue algorithm is provided to minimize subjects having an inadequate response to the treatment for their anemia for an extended period of time and to enable consistency in the application of rescue therapy across the study. The time to stopping of study treatment due to subjects meeting the rescue criteria will be assessed. The date and time of rescue medication administration as well as the name and dosage regimen of the rescue medication must be recorded.|A responder is defined as a subject with mean Hgb within the Hgb analysis range 10 to 11.5 grams/deciliter during the EP. Subjects will be treated to achieve and maintain Hgb between 10 and 11.5 grams/deciliter. The study treatment may be dose-titrated, if needed, during EP to achieve or maintain Hgb level in the target range.|MAP is an average BP in an individual during a single cardiac cycle. Measurements will be taken both pre-dialysis and post-dialysis. Measurements will be taken with the subject is in a semi-supine or seated position in the dialysis chair after at least a 5-minute rest period, pre- and post-dialysis. Measurement of SBP, DBP and MAP will be performed before collection of blood samples for laboratory testing, where applicable.|The calculation of events per subject-years is the number of incident cases divided by the amount of subjects-time at risk. Number of BP exacerbation events per 100 subject years will be calculated.|Number of subjects with at least 1 BP exacerbation event up to Week 52 will be calculated.|Blood samples (6 in total) will be collected at the Day 1 visit pre-dose and at any one post-Baseline visit between Week 8 and Week 52.|Change from Baseline in global symptom severity will be assessed. Symptom severity will be assessed using the PGI-S. The PGI-S is a 1-item questionnaire designed to assess subjects impression of disease severity of their anemia of CKD.|The following hematology parameters will be measured: Hemoglobin, Hematocrit, RBC count, Mean corpuscular volume (MCV), Mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), Red cell distribution width (RDW), Reticulocyte count, Platelet count, white blood cell (WBC) count, Total neutrophils, Eosinophils, Monocytes, Basophils, and Lymphocytes|The following chemistry parameters will be measured: Potassium, Albumin, Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Calcium, Phosphate, Total and direct/indirect bilirubin, and urea (serum).|Measurements will be taken both pre-dialysis and post-dialysis. Measurements will be taken with the subject is in a semi-supine or seated position in the dialysis chair after at least a 5-minute rest period, pre and post-dialysis. Measurement of SBP and DBP will be performed before collection of blood samples for laboratory testing, where applicable.|Measurements will be taken both pre-dialysis and post-dialysis. Measurements will be taken with the subject is in a semi-supine or seated position in the dialysis chair after at least a 5-minute rest period, pre and post-dialysis. Measurement of heart rate will be performed before collection of blood samples for laboratory testing, where applicable.","Up to Week 52|Weeks 28 to 52|Baseline and Week 52|Pre-dose at any one post-Baseline visit between Week 8 and Week 52|Pre-dose and 0.5, 1, 2, 3 hours|Pre-dose and 0.5, 1, 2, 3 hours post-dose|Baseline and up to Week 52",{"$nulls":3},"Mar Del Plata, Buenos Aires, Argentina, 7600 Gsk Investigational SitePergamino, Buenos Aires, Argentina, B2700Cpm Gsk Investigational SiteSarandi, Buenos Aires, Argentina, B1872Eeb|Rosario, Santa Fe, Argentina, 2000|Heidelberg, Victoria, Australia, 3084 Gsk Investigational SiteParkville, Victoria, Australia, 3050|Belo Horizonte, Minas Gerais, Brazil, 30150-221 Gsk Investigational SiteFeira De Santana, Brazil, 44001-465 Gsk Investigational SiteSÃ£o Paulo, Brazil, 04039-000|Curitiba, ParanÃ¡, Brazil, 80440-020|Passo Fundo, Rio Grande Do Sul, Brazil, 99010-080 Gsk Investigational SitePorto Alegre, Rio Grande Do Sul, Brazil, 90610-000|Sao Jose Do Rio Preto, SÃ£o Paulo, Brazil, 15090-000|Oshawa, Ontario, Canada, L1G 2B9|Bayonne, France, 64109 Gsk Investigational SiteEpagny Metz-Tessy, France, 74370 Gsk Investigational SiteLe Mans, France, 72037 Gsk Investigational SiteNice Cedex 1, France, 06001 Gsk Investigational SiteStrasbourg, France, 67000|Bologna, Emilia-Romagna, Italy, 40138 Gsk Investigational SiteModena, Emilia-Romagna, Italy, 41124|Pavia, Lombardia, Italy, 27100|Verona, Veneto, Italy, 37126 Korea, Republic Of Gsk Investigational SiteAnyang-Si, Gyeonggi-Do, Korea, Republic Of, 14068 Gsk Investigational SiteBusan, Korea, Republic Of, 49201 Gsk Investigational SiteGoyang-Si, Gyeonggi-Do, Korea, Republic Of, 10326 Gsk Investigational SiteIncheon, Korea, Republic Of, 405-760 Gsk Investigational SiteSeoul, Korea, Republic Of, 07061 Gsk Investigational SiteSeoul, Korea, Republic Of, 134-727 Gsk Investigational SiteSeoul, Korea, Republic Of, 07441|Katowice, Poland, 40-027 Gsk Investigational SiteLodz, Poland, 92-213 Gsk Investigational SiteSandomierz, Poland, 27-600 Gsk Investigational SiteTarnowskie Gory, Poland, 42-612 Gsk Investigational SiteZyrardow, Poland, 96-300|Constanta, Romania, 900591 Gsk Investigational SiteResita, Romania, 320166 Russian Federation Gsk Investigational SiteKazan, Russian Federation, 420012 Gsk Investigational SiteKolomna, Russian Federation, 140402 Gsk Investigational SiteKrasnodar, Russian Federation, 350029 Gsk Investigational SiteKrasnogorsk, Russian Federation, 143400 Gsk Investigational SiteMytischi, Russian Federation, 141009 Gsk Investigational SiteNovorossiysk, Russian Federation, 353915 Gsk Investigational SiteNovosibirsk, Russian Federation, 630087 Gsk Investigational SiteOmsk, Russian Federation, 644111 Gsk Investigational SiteOrenburg, Russian Federation, 460040 Gsk Investigational SitePenza, Russian Federation, 440034 Gsk Investigational SitePodolsk, Russian Federation, 142110 Gsk Investigational SiteSaint-Petersburg, Russian Federation, 194354 Gsk Investigational SiteSaint-Petersburg, Russian Federation, 197374 Gsk Investigational SiteSt-Petersburg, Russian Federation, 197110 Gsk Investigational SiteSt. Petersburg, Russian Federation, 193318 Gsk Investigational SiteSt. Petersburg, Russian Federation, 194104 Gsk Investigational SiteSt. Petersburg, Russian Federation, 196247 Gsk Investigational SiteUfa, Russian Federation, 450071 Gsk Investigational SiteYaroslavl, Russian Federation, 150062|Almeria, Spain, 04009 Gsk Investigational SiteBadalona, Spain, 08916 Gsk Investigational SiteBarcelona, Spain, 08036 Gsk Investigational SiteGerona, Spain, 17007 Gsk Investigational SiteGranollers, Barcelona, Spain, 08041 Gsk Investigational SiteMadrid, Spain, 28100 Gsk Investigational SiteManises (Valencia), Spain, 46940 Gsk Investigational SiteSanlÃºcar De Barrameda (CÃ¡diz), Spain, 11540|Bradford, United Kingdom, Bd5 0Na Gsk Investigational SiteLondon, United Kingdom, Se5 9Rs Gsk Investigational SiteSheffield, United Kingdom, S5 7Au Gsk Investigational SiteSwansea, United Kingdom, Sa6 6Nl|Mesa, Arizona, United States, 85210|Fresno, California, United States, 93720 Gsk Investigational SiteLos Angeles, California, United States, 90025 Gsk Investigational SiteParamount, California, United States, 90723|Middlebury, Connecticut, United States, 06762|Hollywood, Florida, United States, 33024 Gsk Investigational SiteMiami, Florida, United States, 33169 Gsk Investigational SiteTampa, Florida, United States, 33614|Macon, Georgia, United States, 31201|Meridian, Idaho, United States, 83642|Pittsfield, Massachusetts, United States, 01201|Kansas City, Missouri, United States, 64111 Gsk Investigational SiteSaint Louis, Missouri, United States, 63110|Albuquerque, New|College Point, New York, United States, 11356|Winston-Salem, North Carolina, United States, 27157|Oklahoma City, Oklahoma, United States, 73116|Houston, Texas, United States, 77004 Gsk Investigational SiteHouston, Texas, United States, 77099 Gsk Investigational SiteLufkin, Texas, United States, 75904|Alexandria, Virginia, United States, 22304 Gsk Investigational SiteHampton, Virginia, United States, 23666 Gsk Investigational SiteNorfolk, Virginia, United States, 23510","Arizona|California|Connecticut|Florida|Georgia|Idaho|Massachusetts|Missouri|New Mexico|New York|North Carolina|Oklahoma|Texas|Virginia","Argentina|Australia|Brazil|Canada|France|Italy|Poland|Romania|Spain|United Kingdom|United States","Buenos Aires Gsk Investigational Site|Santa Fe Gsk Investigational Site|Victoria Gsk Investigational Site|Gsk Investigational Site|ParanÃ¡ Gsk Investigational Site|Rio Grande Do Sul Gsk Investigational Site|SÃ£o Paulo Gsk Investigational Site|Ontario Gsk Investigational Site|Emilia-Romagna Gsk Investigational Site|Lombardia Gsk Investigational Site|Veneto Gsk Investigational Site",{"$nulls":3},"GSK Clinical Trials","2020-03-20","2020-05-25T16:36:57.950","2020-05-26T17:10:42.972","NCT03400033"]
["5ecbf42afe30261b1a04826b","NCT03400033","2020-05-25","GlaxoSmithKline","GSK","Active, not recruiting","Anemia Studies in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat-Three-times Weekly Dosing in Dialysis (ASCEND-TD)","Daprodustat|Epoetin alfa","HIF Inhibitor|ESA Activator","Yes","['Daprodustat']","Yes","['HIF Inhibitor']","Phase 3",2,407,"Actual","2018-09-05","2020-07-08",{"$nulls":5},"This Phase 3 study in hemodialysis-dependent subjects with anemia will evaluate the efficacy and safety of daprodustat administered three-times weekly compared to epoetin alfa, the current standard of care. This study includes a 4 week Screening Period, a 52 week Treatment Period and a 4 to 6 week follow-up period. Each subject will remain in the study for up to 62 weeks. Approximately 402 subjects will be randomized to receive either daprodustat three times weekly or epoetin alfa three-times weekly or once weekly, depending on dose level.",null,"A Phase 3 Randomized, Double-blind, Active-controlled, Parallel-group, Multi-center Study in Hemodialysis Participants With Anemia of Chronic Kidney Disease to Evaluate the Efficacy, Safety and Pharmacokinetics of Three-times Weekly Dosing of Daprodustat Compared to Recombinant Human Erythropoietin, Following a Switch From Recombinant Human Erythropoietin or Its Analogs",204837,"Anaemia","Anemia","Hematologic Diseases","Heme & Lymph Diseases","Experimental|Active Comparator","Daprodustat|Epoetin alfa","Subjects randomized to this arm will receive daprodustat tablets titrated doses from 2 to 48 milligrams orally three-times weekly along with saline by IV route for the 52 weeks treatment period.|Subjects randomized to this arm will receive matching placebo tablets to daprodustat orally three-times weekly and Epoetin alfa by IV route for the 52 weeks treatment period.","Drug","Daprodustat tablets|Saline vials or bags|Matching placebo tablets|Epoetin alfa vials","Round, biconvex, white, film-coated tablet in unit dose strengths 2 and 4 milligrams (7 millimeter tablets), 6, 8 and 10 milligrams (9 millimeter tablets) administered by the oral route.|0.9% sodium chloride saline vials or bags administered by the IV route.|Matching placebo to daprodustat tablets supplied as round, biconvex, white, film-coated tablet in unit dose strengths 2 and 4 milligrams (7 millimeter tablets), 6, 8 and 10 milligrams (9 millimeter tablets) administered by the oral route.|Single-dose, preservative-free vials in unit dose strengths of 2000, 3000, 4000 and 10,000 Units/milliliter administered by the IV route.",null,"Daprodustat|Epoetin alfa","\n\n * Subject must be 18 to 99 years of age inclusive, at the time of signing the informed consent.\n * Use of any approved rhEPO or analog for at least 8 weeks prior to the screening visit and continuing during the screening period until randomization (Day 1).\n * Hgb concentration (measured by HemoCue) within the following range: Week -4: Hgb 8 to 11.5 grams/deciliter (5 to 7.1 millimoles/liter). If Hgb is 11.6 to 11.9 grams/deciliter (7.2 to 7.4 millimoles/liter), up to two retests are allowed; the retest value must be between 8 to 11.5 grams/deciliter (5 to 7.1 millimoles/liter). Day 1: Hgb 8 to 11 grams/deciliter (5 to 6.8 millimoles/liter) and receiving at least the minimum rhEPO or analog dose 3. Hgb>11 to 11.5 grams/deciliter (6.8 to 7.1 millimoles/liter) and receiving greater than the minimum rhEPO or analog dose 3.\n * On hemodialysis (including hemofiltration or hemodiafiltration) >90 days prior to screening and continuing during the screening period.\n * On hemodialysis (in-center) >=3 times per week.\n * Male and female subjects are eligible. A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: Not a woman of childbearing potential (WOCBP), or A WOCBP who agrees to follow the contraceptive guidance from at least 28 days prior to first dose of study treatment and for at least 28 days after the last dose of study treatment.\n * Capable of giving signed informed consent.\n * In France, a subject will be eligible for inclusion in this study if he or she is either affiliated to or beneficiary of a social security category.\n\n","\n\n * Planned living-related or living-unrelated kidney transplant within 52 weeks after randomization (Day 1).\n * Ferritin: <=100 nanograms/milliliter (<=100 micrograms/liter), at screening.\n * Transferrin saturation (TSAT): <=20 percent, at screening. If TSAT is 18 to 20 percent, then a retest using a new blood sample can be obtained within 7 days of the final laboratory report; the final retest value must be >20 percent to confirm eligibility.\n * Aplasias: History of bone marrow aplasia or pure red cell aplasia.\n * Conditions, other than anemia of CKD, which can affect erythropoiesis.\n * Myocardial infarction (MI) or acute coronary syndrome within 8 weeks prior to screening through to randomization (Day 1).\n * Stroke or transient ischemic attack within 8 weeks prior to screening through to randomization (Day 1).\n * Heart failure (HF): Chronic Class IV HF, as defined by the New York Heart Association (NYHA) functional classification system.\n * Current uncontrolled hypertension as determined by the investigator that would contraindicate the use of rhEPO.\n * Bazett's correction of QTc interval (QTcB): at Day 1: QTcB >500 milliseconds, or QTcB >530 milliseconds in subjects with bundle branch block. There is no QTc (corrected QT) exclusion for subjects with a predominantly ventricular paced rhythm.\n * Liver Disease: presence of any one of the following liver-related laboratory values or conditions, at screening, is exclusionary: ALT >2x upper limit of normal (ULN); Bilirubin >1.5x ULN; or Current unstable liver or biliary disease per investigator assessment, generally defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis.\n * Evidence of actively bleeding gastric, duodenal or esophageal ulcer disease OR clinically significant gastro intestinal bleeding <= 8 weeks prior to screening through to randomization (Day 1).\n * History of malignancy within 2 years prior to screening through to randomization (Day 1), currently receiving treatment for cancer, or complex kidney cyst (e.g., Bosniak Category IIF, III or IV) >3 centimeters.\n * Use of a strong inhibitor of Cytochrome P4502C8 [CYP2C8] (e.g. gemfibrozil) or a strong inducer of CYP2C8 (e.g. rifampin/rifampicin).\n * History of severe allergic or anaphylactic reactions or hypersensitivity to excipients in the investigational product (daprodustat) or epoetin alfa.\n * Use of another investigational agent within 30 days or within five half-lives of the investigational agent (whichever is longer) or currently participating in a study of an investigational device prior to screening through to randomization (Day 1).\n * Any prior treatment with daprodustat for treatment duration of >30 days.\n * Any other condition, clinical or laboratory abnormality, or examination finding that the investigator considers would put the subject at unacceptable risk, which may affect study compliance (e.g. intolerance to rhEPO) or prevent understanding of the aims or investigational procedures or possible consequences of the study.",{"$nulls":4},"Estimate","2018-01-17","Actual","Anticipated","2020-07-08","Anticipated","2020-05-01","2018-01-08","2018-01-08","2020-05-21","Yes","CKD, EPO, rhEPO, Hemodialysis dependent, Daprodustat","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years","99 Years","All",null,"No","Yes\nIPD for this study will be made available via the Clinical Study Data Request site.",{"$nulls":3},"Yes","No",{"$nulls":17},"2017-004372-56","EudraCT Number","Mean change in Hemoglobin (Hgb) between Baseline and over Evaluation period [EP] (Weeks 28 to 52)","Blood samples will be collected from subjects for Hgb measurements.","Baseline and up to Week 52","Mean monthly intravenous (IV) iron dose per subject up to Week 52|Number of subjects with adverse events (AEs), serious adverse events (SAEs), adverse event of special interest (AESI) and MACE|Percentage of time Hgb will be in the analysis range (10 to 11.5 grams/deciliter) over EP (Weeks 28 to 52)|Time to stopping study treatment due to meeting rescue criteria|Number of responders in the Hgb analysis range over EP (Weeks 28 to 52)|Change from Baseline in SBP, DBP and mean arterial pressure (MAP) at Week 52 and at the end of study treatment|Number of BP exacerbation events per 100 subject years|Number of subjects with at least one BP exacerbation event during the study|Pre-dose trough concentration (Ctau) of daprodustat|Pre-dose Ctau of metabolites M2|Pre-dose Ctau of metabolites M4|Pre-dose Ctau of metabolites M3|Pre-dose Ctau of metabolites M5|Pre-dose Ctau of metabolites M6|Pre-dose Ctau of metabolites M13|Maximum observed concentration (Cmax) of daprodustat|Cmax of metabolites M2|Cmax of metabolites M3|Cmax of metabolites M4|Cmax of metabolites M5|Cmax of metabolites M6|Cmax of metabolites M13|Change from Baseline in Patient Global Impression of Severity (PGI-S) score|Absolute values over time for composite of hematology parameters as a measure of safety|Changes from baseline over time in composite of hematology parameters as a measure of safety|Absolute values over time for composite of chemistry parameters as a measure of safety|Changes from baseline over time in composite of chemistry parameters as a measure of safety|Absolute values of systolic and diastolic blood pressure as a measure of safety|Change from Baseline in systolic and diastolic blood pressure as a measure of safety|Absolute values for heart rate as a measure of safety|Change from Baseline in Heart rate as a measure of safety","IV iron use for all subjects will be recorded in the electronic case record form (eCRF) and the average monthly IV iron dose up to Week 52 while on treatment will be calculated.|AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is medically significant. Along with AE and SAE the study will also assess AESI and MACE events until follow-up Week 52.|Subjects will be treated to achieve and maintain Hgb between 10 and 11.5 grams/deciliter. The study treatment may be dose-titrated, if needed, during EP to achieve or maintain Hgb level in the target range.|A rescue algorithm is provided to minimize subjects having an inadequate response to the treatment for their anemia for an extended period of time and to enable consistency in the application of rescue therapy across the study. The time to stopping of study treatment due to subjects meeting the rescue criteria will be assessed. The date and time of rescue medication administration as well as the name and dosage regimen of the rescue medication must be recorded.|A responder is defined as a subject with mean Hgb within the Hgb analysis range 10 to 11.5 grams/deciliter during the EP. Subjects will be treated to achieve and maintain Hgb between 10 and 11.5 grams/deciliter. The study treatment may be dose-titrated, if needed, during EP to achieve or maintain Hgb level in the target range.|MAP is an average BP in an individual during a single cardiac cycle. Measurements will be taken both pre-dialysis and post-dialysis. Measurements will be taken with the subject is in a semi-supine or seated position in the dialysis chair after at least a 5-minute rest period, pre- and post-dialysis. Measurement of SBP, DBP and MAP will be performed before collection of blood samples for laboratory testing, where applicable.|The calculation of events per subject-years is the number of incident cases divided by the amount of subjects-time at risk. Number of BP exacerbation events per 100 subject years will be calculated.|Number of subjects with at least 1 BP exacerbation event up to Week 52 will be calculated.|Blood samples (6 in total) will be collected at the Day 1 visit pre-dose and at any one post-Baseline visit between Week 8 and Week 52.|Change from Baseline in global symptom severity will be assessed. Symptom severity will be assessed using the PGI-S. The PGI-S is a 1-item questionnaire designed to assess subjects impression of disease severity of their anemia of CKD.|The following hematology parameters will be measured: Hemoglobin, Hematocrit, RBC count, Mean corpuscular volume (MCV), Mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), Red cell distribution width (RDW), Reticulocyte count, Platelet count, white blood cell (WBC) count, Total neutrophils, Eosinophils, Monocytes, Basophils, and Lymphocytes|The following chemistry parameters will be measured: Potassium, Albumin, Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Calcium, Phosphate, Total and direct/indirect bilirubin, and urea (serum).|Measurements will be taken both pre-dialysis and post-dialysis. Measurements will be taken with the subject is in a semi-supine or seated position in the dialysis chair after at least a 5-minute rest period, pre and post-dialysis. Measurement of SBP and DBP will be performed before collection of blood samples for laboratory testing, where applicable.|Measurements will be taken both pre-dialysis and post-dialysis. Measurements will be taken with the subject is in a semi-supine or seated position in the dialysis chair after at least a 5-minute rest period, pre and post-dialysis. Measurement of heart rate will be performed before collection of blood samples for laboratory testing, where applicable.","Up to Week 52|Weeks 28 to 52|Baseline and Week 52|Pre-dose at any one post-Baseline visit between Week 8 and Week 52|Pre-dose and 0.5, 1, 2, 3 hours|Pre-dose and 0.5, 1, 2, 3 hours post-dose|Baseline and up to Week 52",{"$nulls":3},"Mar Del Plata, Buenos Aires, Argentina, 7600 Gsk Investigational SitePergamino, Buenos Aires, Argentina, B2700Cpm Gsk Investigational SiteSarandi, Buenos Aires, Argentina, B1872Eeb|Rosario, Santa Fe, Argentina, 2000|Heidelberg, Victoria, Australia, 3084 Gsk Investigational SiteParkville, Victoria, Australia, 3050|Belo Horizonte, Minas Gerais, Brazil, 30150-221 Gsk Investigational SiteFeira De Santana, Brazil, 44001-465 Gsk Investigational SiteSÃ£o Paulo, Brazil, 04039-000|Curitiba, ParanÃ¡, Brazil, 80440-020|Passo Fundo, Rio Grande Do Sul, Brazil, 99010-080 Gsk Investigational SitePorto Alegre, Rio Grande Do Sul, Brazil, 90610-000|Sao Jose Do Rio Preto, SÃ£o Paulo, Brazil, 15090-000|Oshawa, Ontario, Canada, L1G 2B9|Bayonne, France, 64109 Gsk Investigational SiteEpagny Metz-Tessy, France, 74370 Gsk Investigational SiteLe Mans, France, 72037 Gsk Investigational SiteNice Cedex 1, France, 06001 Gsk Investigational SiteStrasbourg, France, 67000|Bologna, Emilia-Romagna, Italy, 40138 Gsk Investigational SiteModena, Emilia-Romagna, Italy, 41124|Pavia, Lombardia, Italy, 27100|Verona, Veneto, Italy, 37126 Korea, Republic Of Gsk Investigational SiteAnyang-Si, Gyeonggi-Do, Korea, Republic Of, 14068 Gsk Investigational SiteBusan, Korea, Republic Of, 49201 Gsk Investigational SiteGoyang-Si, Gyeonggi-Do, Korea, Republic Of, 10326 Gsk Investigational SiteIncheon, Korea, Republic Of, 405-760 Gsk Investigational SiteSeoul, Korea, Republic Of, 07061 Gsk Investigational SiteSeoul, Korea, Republic Of, 134-727 Gsk Investigational SiteSeoul, Korea, Republic Of, 07441|Katowice, Poland, 40-027 Gsk Investigational SiteLodz, Poland, 92-213 Gsk Investigational SiteSandomierz, Poland, 27-600 Gsk Investigational SiteTarnowskie Gory, Poland, 42-612 Gsk Investigational SiteZyrardow, Poland, 96-300|Constanta, Romania, 900591 Gsk Investigational SiteResita, Romania, 320166 Russian Federation Gsk Investigational SiteKazan, Russian Federation, 420012 Gsk Investigational SiteKolomna, Russian Federation, 140402 Gsk Investigational SiteKrasnodar, Russian Federation, 350029 Gsk Investigational SiteKrasnogorsk, Russian Federation, 143400 Gsk Investigational SiteMytischi, Russian Federation, 141009 Gsk Investigational SiteNovorossiysk, Russian Federation, 353915 Gsk Investigational SiteNovosibirsk, Russian Federation, 630087 Gsk Investigational SiteOmsk, Russian Federation, 644111 Gsk Investigational SiteOrenburg, Russian Federation, 460040 Gsk Investigational SitePenza, Russian Federation, 440034 Gsk Investigational SitePodolsk, Russian Federation, 142110 Gsk Investigational SiteSaint-Petersburg, Russian Federation, 194354 Gsk Investigational SiteSaint-Petersburg, Russian Federation, 197374 Gsk Investigational SiteSt-Petersburg, Russian Federation, 197110 Gsk Investigational SiteSt. Petersburg, Russian Federation, 193318 Gsk Investigational SiteSt. Petersburg, Russian Federation, 194104 Gsk Investigational SiteSt. Petersburg, Russian Federation, 196247 Gsk Investigational SiteUfa, Russian Federation, 450071 Gsk Investigational SiteYaroslavl, Russian Federation, 150062|Almeria, Spain, 04009 Gsk Investigational SiteBadalona, Spain, 08916 Gsk Investigational SiteBarcelona, Spain, 08036 Gsk Investigational SiteGerona, Spain, 17007 Gsk Investigational SiteGranollers, Barcelona, Spain, 08041 Gsk Investigational SiteMadrid, Spain, 28100 Gsk Investigational SiteManises (Valencia), Spain, 46940 Gsk Investigational SiteSanlÃºcar De Barrameda (CÃ¡diz), Spain, 11540|Bradford, United Kingdom, Bd5 0Na Gsk Investigational SiteLondon, United Kingdom, Se5 9Rs Gsk Investigational SiteSheffield, United Kingdom, S5 7Au Gsk Investigational SiteSwansea, United Kingdom, Sa6 6Nl|Mesa, Arizona, United States, 85210|Fresno, California, United States, 93720 Gsk Investigational SiteLos Angeles, California, United States, 90025 Gsk Investigational SiteParamount, California, United States, 90723|Middlebury, Connecticut, United States, 06762|Hollywood, Florida, United States, 33024 Gsk Investigational SiteMiami, Florida, United States, 33169 Gsk Investigational SiteTampa, Florida, United States, 33614|Macon, Georgia, United States, 31201|Meridian, Idaho, United States, 83642|Pittsfield, Massachusetts, United States, 01201|Kansas City, Missouri, United States, 64111 Gsk Investigational SiteSaint Louis, Missouri, United States, 63110|Albuquerque, New|College Point, New York, United States, 11356|Winston-Salem, North Carolina, United States, 27157|Oklahoma City, Oklahoma, United States, 73116|Houston, Texas, United States, 77004 Gsk Investigational SiteHouston, Texas, United States, 77099 Gsk Investigational SiteLufkin, Texas, United States, 75904|Alexandria, Virginia, United States, 22304 Gsk Investigational SiteHampton, Virginia, United States, 23666 Gsk Investigational SiteNorfolk, Virginia, United States, 23510","Arizona|California|Connecticut|Florida|Georgia|Idaho|Massachusetts|Missouri|New Mexico|New York|North Carolina|Oklahoma|Texas|Virginia","Argentina|Australia|Brazil|Canada|France|Italy|Poland|Romania|Spain|United Kingdom|United States","Buenos Aires Gsk Investigational Site|Santa Fe Gsk Investigational Site|Victoria Gsk Investigational Site|Gsk Investigational Site|ParanÃ¡ Gsk Investigational Site|Rio Grande Do Sul Gsk Investigational Site|SÃ£o Paulo Gsk Investigational Site|Ontario Gsk Investigational Site|Emilia-Romagna Gsk Investigational Site|Lombardia Gsk Investigational Site|Veneto Gsk Investigational Site",{"$nulls":3},"GSK Clinical Trials","2020-05-21","2020-05-25T16:36:58.275","2020-05-26T17:10:42.972","NCT03400033"]
["5ecbf42c307e3d1b1f8d9cff","NCT03400176","2018-01-17","Novartis","NVS","Not yet recruiting","VAY736 in Combination With Ibrutinib in Patients With CLL on Ibrutinib","Ianalumab|Ibrutinib","BLyS Inhibitor|Btk Inhibitor|ERBB2 Inhibitor","Yes","['Ianalumab']","No",null,"Phase 1",2,60,"Anticipated","2018-01-15","2019-07-26",{"$nulls":5},"Patients enrolled to the study will have chronic lymphocytic leukemia (CLL) and are actively receiving ibrutinib. Patients will have either been receiving ibrutinib for one year without having had a complete response or patients will have developed a resistance mutation to ibrutinib. This study will have two parts, a dose escalation part and a dose expansion part. In the dose escalation part, the maximum tolerated dose (MTD) of the combination of VAY736 with ibrutinib will be determined. Once determined, the dose expansion part of the study will begin.",null,"Phase Ib Open-label Study of VAY736 and Ibrutinib in Patients With Chronic Lymphocytic Leukemia (CLL) on Ibrutinib Therapy","CVAY736Y2102","Chronic Lymphocytic Leukemia (CLL)","Leukemia|Chronic Leukemia|Lymphoid Leukemia|Chronic Lymphoid Leukemia","Oncology Hematological","Oncology","Experimental","Dose Escalation|Dose expansion","Increasing doses of VAY736 in combination with a fixed dose of ibrutinib.|Evaluation of the MTD/RD of the combination of VAY736 and ibrutinib that was identified in dose escalation.","Drug","VAY736|ibrutinib","Experimental|Approved medication","Imbruvica","Dose Escalation|Dose expansion","\n\n * Diagnosis of CLL per the WHO classification\n * At least 18 years of age\n * Lack of a complete response after receiving ibrutinib for > 1 year OR presence of known ibrutinib resistance mutation\n * Actively receiving ibrutinib at either 420 mg (patients enrolled to the escalation arm) or at a stable dose for at least 2 months prior to starting study treatment (patients enrolled to the expansion arm)\n\n","\n\n * Known history of HIV\n * Active hepatitis B or C infection\n * Receipt of attenuated vaccine within 2 weeks prior to starting study treatment.",{"$nulls":4},"Actual","2018-01-17","Actual","Anticipated","2020-07-26","Anticipated","2018-01-01","2018-01-09","2018-01-09","2018-01-09","No","Ibrutinib\nVAY736\nChronic lymphocytic leukemia\nCLL\nBruton's Tyrosine Kinase\nBTK mutation","Interventional","Treatment","Single Group Assignment","None (Open Label)","Non-Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":19},"DLT rate","To determine the incidence of DLTs.","1 year","Overall Response Rate (ORR)|Time to progression (TTP)","To determine preliminary antitumor activity of the combination.|Two years","Two years",{"$nulls":11},"2018-01-09","2020-05-25T16:37:00.947","2020-05-26T17:10:42.972","NCT03400176"]
["5ecbf42de2561b1b11905d6a","NCT03400176","2018-09-24","Novartis","NVS","Recruiting","VAY736 in Combination With Ibrutinib in Patients With CLL on Ibrutinib","Ianalumab|Ibrutinib","BLyS Inhibitor|Btk Inhibitor|ERBB2 Inhibitor","Yes","['Ianalumab']","No",null,"Phase 1",2,60,"Anticipated","2018-04-09","2019-10-21",{"$nulls":5},"Patients enrolled to the study will have chronic lymphocytic leukemia (CLL) and are actively receiving ibrutinib. Patients will have either been receiving ibrutinib for one year without having had a complete response or patients will have developed a resistance mutation to ibrutinib. This study will have two parts, a dose escalation part and a dose expansion part. In the dose escalation part, the maximum tolerated dose (MTD) of the combination of VAY736 with ibrutinib will be determined. Once determined, the dose expansion part of the study will begin.",null,"Phase Ib Open-label Study of VAY736 and Ibrutinib in Patients With Chronic Lymphocytic Leukemia (CLL) on Ibrutinib Therapy","CVAY736Y2102","Chronic Lymphocytic Leukemia (CLL)","Leukemia|Chronic Leukemia|Lymphoid Leukemia|Chronic Lymphoid Leukemia","Oncology Hematological","Oncology","Experimental","Dose Escalation|Dose expansion","Increasing doses of VAY736 in combination with a fixed dose of ibrutinib.|Evaluation of the MTD/RD of the combination of VAY736 and ibrutinib that was identified in dose escalation.","Drug","VAY736|ibrutinib","Experimental|Approved medication","Imbruvica","Dose Escalation|Dose expansion","\n\n * Diagnosis of CLL per the WHO classification\n * At least 18 years of age\n * Lack of a complete response after receiving ibrutinib for > 1 year OR presence of known ibrutinib resistance mutation\n * Actively receiving ibrutinib at either 420 mg (patients enrolled to the escalation arm) or at a stable dose for at least 2 months prior to starting study treatment (patients enrolled to the expansion arm)\n\n","\n\n * Known history of HIV\n * Active hepatitis B or C infection\n * Receipt of attenuated vaccine within 2 weeks prior to starting study treatment.",{"$nulls":4},"Actual","2018-01-17","Actual","Anticipated","2019-10-21","Anticipated","2018-09-01","2018-01-09","2018-01-09","2018-09-21","No","Ibrutinib\nVAY736\nChronic lymphocytic leukemia\nCLL\nBruton's Tyrosine Kinase\nBTK mutation","Interventional","Treatment","Single Group Assignment","None (Open Label)","Non-Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":19},"DLT rate","To determine the incidence of DLTs.","1 year","Overall Response Rate (ORR)|Time to progression (TTP)","To determine preliminary antitumor activity of the combination.|Two years","Two years",{"$nulls":3},"Columbus, Ohio, United States, 43210|Nashville, Tennessee, United States, 37203","Ohio|Tennessee","United States","Novartis Investigative Site",{"$nulls":4},"2018-09-21","2020-05-25T16:37:01.135","2020-05-26T17:10:42.972","NCT03400176"]
["5ecbf42d307e3d1b1f8d9d00","NCT03400176","2019-10-03","Novartis","NVS","Recruiting","VAY736 in Combination With Ibrutinib in Patients With CLL on Ibrutinib","Ianalumab|Ibrutinib","BLyS Inhibitor|Btk Inhibitor|ERBB2 Inhibitor","Yes","['Ianalumab']","No",null,"Phase 1",2,60,"Anticipated","2018-04-09","2020-09-16",{"$nulls":5},"Patients enrolled to the study will have chronic lymphocytic leukemia (CLL) and are actively receiving ibrutinib. Patients will have either been receiving ibrutinib for one year without having had a complete response or patients will have developed a resistance mutation to ibrutinib. This study will have two parts, a dose escalation part and a dose expansion part. In the dose escalation part, the maximum tolerated dose (MTD) of the combination of VAY736 with ibrutinib will be determined. Once determined, the dose expansion part of the study will begin.",null,"Phase Ib Open-label Study of VAY736 and Ibrutinib in Patients With Chronic Lymphocytic Leukemia (CLL) on Ibrutinib Therapy","CVAY736Y2102","Chronic Lymphocytic Leukemia (CLL)","Leukemia|Chronic Leukemia|Lymphoid Leukemia|Chronic Lymphoid Leukemia","Oncology Hematological","Oncology","Experimental","Dose Escalation|Dose expansion","Increasing doses of VAY736 in combination with a fixed dose of ibrutinib.|Evaluation of the MTD/RD of the combination of VAY736 and ibrutinib that was identified in dose escalation.","Drug","VAY736|ibrutinib","Experimental|Approved medication","Imbruvica","Dose Escalation|Dose expansion","\n\n * Diagnosis of CLL per the WHO classification\n * At least 18 years of age\n * Lack of a complete response after receiving ibrutinib for > 1 year OR presence of known ibrutinib resistance mutation\n * Actively receiving ibrutinib at either 420 mg (patients enrolled to the escalation arm) or at a stable dose for at least 2 months prior to starting study treatment (patients enrolled to the expansion arm)\n\n","\n\n * Known history of HIV\n * Active hepatitis B or C infection\n * Receipt of attenuated vaccine within 2 weeks prior to starting study treatment.",{"$nulls":4},"Actual","2018-01-17","Actual","Anticipated","2020-09-16","Anticipated","2019-10-01","2018-01-09","2018-01-09","2019-10-02","No","Ibrutinib\nVAY736\nChronic lymphocytic leukemia\nCLL\nBruton's Tyrosine Kinase\nBTK mutation","Interventional","Treatment","Single Group Assignment","None (Open Label)","Non-Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":19},"DLT rate","To determine the incidence of DLTs.","1 year","Overall Response Rate (ORR)|Time to progression (TTP)","To determine preliminary antitumor activity of the combination.|Two years","Two years",{"$nulls":3},"Columbus, Ohio, United States, 43210|Nashville, Tennessee, United States, 37203","Ohio|Tennessee","United States","Novartis Investigative Site",{"$nulls":4},"2019-10-02","2020-05-25T16:37:01.143","2020-05-26T17:10:42.972","NCT03400176"]
["5ecbf42efe30261b1a048271","NCT03400306","2018-01-17","AbbVie","ABBV","Not yet recruiting","A Study Evaluating the Bioavailability and Food Effect of Veliparib Tablets Followed by an Extension in Subjects With Ovarian Cancer","Veliparib|Carboplatin|Paclitaxel","PARP Inhibitor|DNA Synthesis Inhibitor|Mitosis Inhibitor|Tubulin Inhibitor|Tubulin Inhibitor","Yes","['Veliparib']","No",null,"Phase 1",3,54,"Anticipated","2018-03-30","2019-02-25","AUC|Clast","Area Under The Curve|Last Quantifiable Plasma Concentration",{"$nulls":3},"This study will evaluate the bioavailability between the veliparib tablet formulation to the capsule formulation; and will assess the effect of food on veliparib bioavailability in participants with ovarian cancer.",null,"A Phase 1, Single-Dose, Open-Label, Randomized Cross-Over Study Evaluating the Bioavailability and Food Effect of Veliparib Tablets Followed by an Extension in Subjects With Ovarian Cancer","M15-536","Cancer - Ovarian","Ovarian Cancer","Oncology Solid Tumor","Oncology","Experimental","Part 1, Bioequivalence Sequence Group 1|Part 2, Extension|Part 1, Bioequivalence Sequence Group 2","Veliparib 400-mg doses administered orally on Day 1 of each 2-3 day period in Part 1 with the following sequence for the 3 dosing days: four 100 mg capsules under fasting conditions, followed by one 400-mg tablet under fasting conditions, then one 400 mg tablet under non-fasting conditions.|Veliparib as monotherapy or in combination with carboplatin and paclitaxel, per investigators' discretion.|Veliparib 400-mg doses administered orally on Day 1 of each 2-3 day period in Part 1 with the following sequence for the 3 dosing days: one 400-mg tablet under fasting conditions, followed by four 100 mg capsules under fasting conditions, then one 400 mg tablet under non-fasting conditions.","Drug","Veliparib, capsule|Veliparib, tablet|Carboplatin|Paclitaxel","capsule; 50 mg or 100 mg|tablet; 400 mg|Intravenous","ABT-888|Paraplatin|Taxol","Part 1, Bioequivalence Sequence Group 1|Part 2, Extension|Part 1, Bioequivalence Sequence Group 2","\n\n * Diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.\n * Laboratory values meeting protocol-specified criteria, including hematologic, kidney and liver function.\n * Life expectancy of 12 weeks or greater.\n * Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.\n * Able to swallow and retain oral medication.\n * Discontinued anti-cancer therapy and biological agent for antineoplastic intent 28 days prior to the first dose of study drug, not have undergone major surgery 28 days prior to the first dose of study drug; and have recovered to Grade 0 - 2 for any clinical significant adverse event effect(s)/toxicity(s) from previous therapy.\n * Non-childbearing potential.\n\n","\n\n * History or active medical condition(s) affecting absorption or motility or any surgical procedure that might interfere with gastrointestinal motility, pH or absorption.\n * Evidence of refractory ascites.\n * Has clinically relevant or significant electrocardiogram abnormalities.",{"$nulls":4},"Actual","2018-01-17","Actual","Anticipated","2020-04-12","Anticipated","2018-01-01","2018-01-12","2018-01-12","2018-01-12","No","Cancer Ovarian cancer Bioavailability Pharmacokinetics Bioequivalence","Interventional","Treatment","Crossover Assignment","None (Open Label)","Randomized","18 Years","99 Years","Female",null,"No","Undecided",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":14},"Maximum observed plasma concentration (Cmax)|Time to Maximum Observed Plasma Concentration (Tmax)|Apparent Terminal Phase Elimination Rate Constant (Î² or Beta)|Terminal Phase Elimination Half-life (t1/2)|Area Under the Plasma Concentration-time Curve (AUC) from Time 0 to Time of the Last Measurable Concentration (AUCt)|AUC from time 0 to infinite time (AUCâˆž)","Maximum observed plasma concentration (Cmax)|Time to maximum observed plasma concentration (Tmax).|Apparent terminal phase elimination rate constant (Î² or Beta).|Terminal phase elimination half-life (t1/2)|Area under the plasma concentration-time curve (AUC) from time 0 to time of the last measurable concentration (AUCt).|AUC from time 0 to infinite time (AUCâˆž)","Up to approximately 8 days after initial dose of study drug",{"$nulls":3},"abbvieclinicaltrials@abbvie.com","ABBVIE CALL CENTER","847.283.8955",{"$nulls":7},"AbbVie Inc.","2018-01-12","2020-05-25T16:37:02.385","2020-05-26T17:10:42.972","NCT03400306"]
["5ecbf42efe30261b1a048272","NCT03400306","2018-10-18","AbbVie","ABBV","Not yet recruiting","A Study Evaluating the Bioavailability and Food Effect of Veliparib Tablets Followed by an Extension in Subjects With Ovarian Cancer","Veliparib|Carboplatin|Paclitaxel","PARP Inhibitor|DNA Synthesis Inhibitor|Mitosis Inhibitor|Tubulin Inhibitor|Tubulin Inhibitor","Yes","['Veliparib']","No",null,"Phase 1",3,54,"Anticipated","2020-05-10","2021-03-13","AUC|Clast","Area Under The Curve|Last Quantifiable Plasma Concentration",{"$nulls":3},"This study will evaluate the bioavailability between the veliparib tablet formulation to the capsule formulation; and will assess the effect of food on veliparib bioavailability in participants with ovarian cancer.",null,"A Phase 1, Single-Dose, Open-Label, Randomized Cross-Over Study Evaluating the Bioavailability and Food Effect of Veliparib Tablets Followed by an Extension in Subjects With Ovarian Cancer","M15-536","Cancer - Ovarian","Ovarian Cancer","Oncology Solid Tumor","Oncology","Experimental","Part 1, Bioequivalence Sequence Group 1|Part 2, Extension|Part 1, Bioequivalence Sequence Group 2","Veliparib 400-mg doses administered orally on Day 1 of each 2-3 day period in Part 1 with the following sequence for the 3 dosing days: four 100 mg capsules under fasting conditions, followed by one 400-mg tablet under fasting conditions, then one 400 mg tablet under non-fasting conditions.|Veliparib as monotherapy or in combination with carboplatin and paclitaxel, per investigators' discretion.|Veliparib 400-mg doses administered orally on Day 1 of each 2-3 day period in Part 1 with the following sequence for the 3 dosing days: one 400-mg tablet under fasting conditions, followed by four 100 mg capsules under fasting conditions, then one 400 mg tablet under non-fasting conditions.","Drug","Veliparib, capsule|Veliparib, tablet|Carboplatin|Paclitaxel","capsule; 50 mg or 100 mg|tablet; 400 mg|Intravenous","ABT-888|Paraplatin|Taxol","Part 1, Bioequivalence Sequence Group 1|Part 2, Extension|Part 1, Bioequivalence Sequence Group 2","\n\n * Diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.\n * Laboratory values meeting protocol-specified criteria, including hematologic, kidney and liver function.\n * Life expectancy of 12 weeks or greater.\n * Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.\n * Able to swallow and retain oral medication.\n * Discontinued anti-cancer therapy and biological agent for antineoplastic intent 21 days prior to the first dose of study drug, not have undergone major surgery 28 days prior to the first dose of study drug; and have recovered to Grade 0 - 2 for any clinical significant adverse event effect(s)/toxicity(s) from previous therapy.\n * Non-childbearing potential.\n\n","\n\n * History or active medical condition(s) affecting absorption or motility or any surgical procedure that might interfere with gastrointestinal motility, pH or absorption.\n * Evidence of refractory ascites.\n * Has clinically relevant or significant electrocardiogram abnormalities.",{"$nulls":4},"Actual","2018-01-17","Actual","Anticipated","2022-05-24","Anticipated","2018-10-01","2018-01-12","2018-01-12","2018-10-17","No","Cancer - Ovarian cancer\nBioavailability\nPharmacokinetics\nBioequivalence","Interventional","Treatment","Crossover Assignment","None (Open Label)","Randomized","18 Years","99 Years","Female",null,"No","Undecided",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":14},"Maximum observed plasma concentration (Cmax)|Time to Maximum Observed Plasma Concentration (Tmax)|Apparent Terminal Phase Elimination Rate Constant (Î² or Beta)|Terminal Phase Elimination Half-life (t1/2)|Area Under the Plasma Concentration-time Curve (AUC) from Time 0 to Time of the Last Measurable Concentration (AUCt)|AUC from time 0 to infinite time (AUCâˆž)","Maximum observed plasma concentration (Cmax)|Time to maximum observed plasma concentration (Tmax).|Apparent terminal phase elimination rate constant (Î² or Beta).|Terminal phase elimination half-life (t1/2)|Area under the plasma concentration-time curve (AUC) from time 0 to time of the last measurable concentration (AUCt).|AUC from time 0 to infinite time (AUCâˆž)","Up to approximately 8 days after initial dose of study drug",{"$nulls":3},"abbvieclinicaltrials@abbvie.com","ABBVIE CALL CENTER","847.283.8955","Herlev, Hovedstaden, Denmark, 2730|Rotterdam, Netherlands, 3015 Ce|Amsterdam, Noord-Holland, Netherlands, 1066 Cx|Detroit, Michigan, United States, 48201|Tulsa, Oklahoma, United States, 74135-2527|Providence, Rhode Island, United States, 02903-4923|Salt Lake City, Utah, United States, 84112-5500","Michigan|Oklahoma|Rhode Island|Utah","Denmark|Netherlands|United States","Hovedstaden Herlev Hospital /Id# 201073|Erasmus Medisch Centrum /Id# 201555|Noord-Holland Antoni Van Leeuwenhoek /Id# 202356|Karmanos Cancer Center /Id# 200136|University Of Oklahoma /Id# 171276|Lifespan Cancer Institute /Id# 200130|Huntsman Cancer Institute /Id# 200135",{"$nulls":3},"AbbVie Inc.","2018-10-17","2020-05-25T16:37:02.709","2020-05-26T17:10:42.972","NCT03400306"]
["5ecbf42e307e3d1b1f8d9d03","NCT03400306","2020-03-23","AbbVie","ABBV","Not yet recruiting","A Study Evaluating the Bioavailability and Food Effect of Veliparib Tablets Followed by an Extension in Subjects With Ovarian Cancer","Veliparib|Carboplatin|Paclitaxel","PARP Inhibitor|DNA Synthesis Inhibitor|Mitosis Inhibitor|Tubulin Inhibitor|Tubulin Inhibitor","Yes","['Veliparib']","No",null,"Phase 1",3,54,"Anticipated","2022-05-24","2024-06-07","AUC|Clast","Area Under The Curve|Last Quantifiable Plasma Concentration",{"$nulls":3},"This study will evaluate the bioavailability between the veliparib tablet formulation to the capsule formulation; and will assess the effect of food on veliparib bioavailability in participants with ovarian cancer.",null,"A Phase 1, Single-Dose, Open-Label, Randomized Cross-Over Study Evaluating the Bioavailability and Food Effect of Veliparib Tablets Followed by an Extension in Subjects With Ovarian Cancer","M15-536","Cancer - Ovarian","Ovarian Cancer","Oncology Solid Tumor","Oncology","Experimental","Part 1, Bioequivalence Sequence Group 1|Part 2, Extension|Part 1, Bioequivalence Sequence Group 2","Veliparib 400-mg doses administered orally on Day 1 of each 2-3 day period in Part 1 with the following sequence for the 3 dosing days: four 100 mg capsules under fasting conditions, followed by one 400-mg tablet under fasting conditions, then one 400 mg tablet under non-fasting conditions.|Veliparib as monotherapy or in combination with carboplatin and paclitaxel, per investigators' discretion.|Veliparib 400-mg doses administered orally on Day 1 of each 2-3 day period in Part 1 with the following sequence for the 3 dosing days: one 400-mg tablet under fasting conditions, followed by four 100 mg capsules under fasting conditions, then one 400 mg tablet under non-fasting conditions.","Drug","Veliparib, capsule|Veliparib, tablet|Carboplatin|Paclitaxel","capsule; 50 mg or 100 mg|tablet; 400 mg|Intravenous","ABT-888|Paraplatin|Taxol","Part 1, Bioequivalence Sequence Group 1|Part 2, Extension|Part 1, Bioequivalence Sequence Group 2","\n\n * Diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.\n * Laboratory values meeting protocol-specified criteria, including hematologic, kidney and liver function.\n * Life expectancy of 12 weeks or greater.\n * Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.\n * Able to swallow and retain oral medication.\n * Discontinued anti-cancer therapy and biological agent for antineoplastic intent 21 days prior to the first dose of study drug, not have undergone major surgery 28 days prior to the first dose of study drug; and have recovered to Grade 0 - 2 for any clinical significant adverse event effect(s)/toxicity(s) from previous therapy.\n * Non-childbearing potential.\n\n","\n\n * History or active medical condition(s) affecting absorption or motility or any surgical procedure that might interfere with gastrointestinal motility, pH or absorption.\n * Evidence of refractory ascites.\n * Has clinically relevant or significant electrocardiogram abnormalities.",{"$nulls":4},"Actual","2018-01-17","Actual","Anticipated","2024-06-07","Anticipated","2020-03-01","2018-01-12","2018-01-12","2020-03-19","No","Cancer - Ovarian cancer\nBioavailability\nPharmacokinetics\nBioequivalence","Interventional","Treatment","Crossover Assignment","None (Open Label)","Randomized","18 Years","99 Years","Female",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2018-000313-20","EudraCT Number","Maximum observed plasma concentration (Cmax)|Time to Maximum Observed Plasma Concentration (Tmax)|Apparent Terminal Phase Elimination Rate Constant (Î² or Beta)|Terminal Phase Elimination Half-life (t1/2)|Area Under the Plasma Concentration-time Curve (AUC) from Time 0 to Time of the Last Measurable Concentration (AUCt)|AUC from time 0 to infinite time (AUCâˆž)","Maximum observed plasma concentration (Cmax)|Time to maximum observed plasma concentration (Tmax).|Apparent terminal phase elimination rate constant (Î² or Beta).|Terminal phase elimination half-life (t1/2)|Area under the plasma concentration-time curve (AUC) from time 0 to time of the last measurable concentration (AUCt).|AUC from time 0 to infinite time (AUCâˆž)","Up to approximately 8 days after initial dose of study drug",{"$nulls":3},"abbvieclinicaltrials@abbvie.com","ABBVIE CALL CENTER","847.283.8955","Herlev, Hovedstaden, Denmark, 2730|Detroit, Michigan, United States, 48201|Providence, Rhode Island, United States, 02903-4923|Salt Lake City, Utah, United States, 84112-5500","Michigan|Rhode Island|Utah","Denmark|United States","Hovedstaden Herlev Hospital /Id# 201073|Karmanos Cancer Center /Id# 200136|Lifespan Cancer Institute /Id# 200130|Huntsman Cancer Institute /Id# 200135",{"$nulls":3},"AbbVie Inc.","2020-03-19","2020-05-25T16:37:02.784","2020-05-26T17:10:42.972","NCT03400306"]
["5ecbf42ffe30261b1a048273","NCT03400332","2018-02-14","Bristol-Myers Squibb","BMY","Recruiting","An Investigational Immuno-Therapy Study of Experimental Medication BMS-986253 Given in Combination With Nivolumab in Patients With Advanced Cancers","Bms-986253|Nivolumab","IL8 Inhibitor|PD-1 Inhibitor","Yes","['Bms-986253']","No",null,"Phase 1/Phase 2",2,260,"Anticipated","2018-02-12","2023-02-28","DLT","Dose Limiting Toxicity",{"$nulls":3},"The purpose of this study is to investigate experimental medication BMS-986253 in combination with Nivolumab in patients with advanced cancers.",null,"A Phase 1/2a Study of BMS-986253 in Combination With Nivolumab in Advanced Cancers","CA027-002","Cancer","Oncology Unspecified","Oncology Unspecified","Oncology","Experimental","Dose Finding|Dose Expansion","BMS-986253 administered in combination with Nivolumab","Drug|Biological","BMS-986253|Nivolumab","Specified dose on specified days","BMS-936558 | Opdivo","Dose Finding|Dose Expansion","\n\n * Histologic or cytologic confirmation of a solid tumor that is advanced (metastatic, recurrent and/or unresectable) with measurable disease per RECIST v1.1\n * At least 1 lesion accessible for biopsy\n * Eastern Cooperative Oncology Group Performance Status of 0 or 1\n\n","\n\n * Participants with primary central nervous system (CNS) tumors, or with CNS metastases as the only site of active disease (Participants with controlled brain metastases; however, will be allowed to enroll)\n * Participants with active, known or suspected autoimmune disease\n * Participants with conditions requiring systemic treatment with either corticosteroids (> 10mg prednisone equivalents) or other immunosuppressive medications within 14 days of study treatment administration\n * Participants with a known history of testing positive for Human Immunodeficiency Virus (HIV) or known Acquired Immunodeficiency Syndrome (AIDS)\n * Cytotoxic agents, unless at least 4 weeks have elapsed from last dose of prior anti-cancer therapy and initiation of study therapy\n\nOther protocol defined inclusion/exclusion criteria could apply",{"$nulls":4},"Actual","2018-01-17","Actual","Anticipated","2023-03-01","Anticipated","2018-02-01","2018-01-12","2018-01-12","2018-02-13",null,null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No",null,null,"URL: http://bms.com/studyconnect/Pages/home.aspx [http://bms.com/studyconnect/Pages/home.aspx] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: BMS Clinical Trial Patient Recruiting",null,"Yes","No",{"$nulls":19},"Incidence of adverse events (AE)|Incidence of serious adverse events (SAE)|Incidence of AEs meeting protocol-defined dose limiting toxicities (DLT) criteria|Incidence of AEs leading to discontinuation|Incidence of deaths|Incidence of labornatory abnormalities","Approximately 5 years",null,"Overall response rate (ORR)|Median duration of response (mDOR)|Incidence of anti-drug antibody (ADA) to BMS-986253|Serum biomarker concentration|Maximum observed serum concentration (Cmax)|Time of maximum observed serum concentration (Tmax)|Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]|Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)]|Observed serum concentration at the end of a dosing interval (CTAU)|Trough observed serum concentration at the end of the dosing interval (CTROUGH)","Approximately 5 years",null,"Clinical.Trials@bms.com","Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,","please email:","Baltimore, Maryland, United States, 21287|Ann Arbor, Michigan, United States, 48109|Hackensack, New Jersey, United States, 07601|New York, New York, United States, 10032|Pittsburgh, Pennsylvania, United States, 15213","Maryland|Michigan|New Jersey|New York|Pennsylvania","United States","Local Institution|Upmc Cancer Center",null,"First line of the email MUST contain NCT # and Site #.",null,"Bristol-Myers Squibb","2018-02-13","2020-05-25T16:37:03.172","2020-05-26T17:10:42.972","NCT03400332"]
["5ecbf42ffeab101b155308a5","NCT03400332","2018-05-01","Bristol-Myers Squibb","BMY","Recruiting","An Investigational Immuno-Therapy Study of Experimental Medication BMS-986253 Given in Combination With Nivolumab in Patients With Advanced Cancers","Bms-986253|Nivolumab","IL8 Inhibitor|PD-1 Inhibitor","Yes","['Bms-986253']","No",null,"Phase 1/Phase 2",2,260,"Anticipated","2018-01-31","2023-02-28","DLT","Dose Limiting Toxicity",{"$nulls":3},"The purpose of this study is to investigate experimental medication BMS-986253 in combination with Nivolumab in patients with advanced cancers.",null,"A Phase 1/2a Study of BMS-986253 in Combination With Nivolumab in Advanced Cancers","CA027-002","Cancer","Oncology Unspecified","Oncology Unspecified","Oncology","Experimental","Dose Finding|Dose Expansion","BMS-986253 administered in combination with Nivolumab","Drug|Biological","BMS-986253|Nivolumab","Specified dose on specified days","BMS-936558 | Opdivo","Dose Finding|Dose Expansion","\n\n * Histologic or cytologic confirmation of a solid tumor that is advanced (metastatic, recurrent and/or unresectable) with measurable disease per RECIST v1.1\n * At least 1 lesion accessible for biopsy\n * Eastern Cooperative Oncology Group Performance Status of 0 or 1\n\n","\n\n * Participants with primary central nervous system (CNS) tumors, or with CNS metastases as the only site of active disease (Participants with controlled brain metastases; however, will be allowed to enroll)\n * Participants with active, known or suspected autoimmune disease\n * Participants with conditions requiring systemic treatment with either corticosteroids (> 10mg prednisone equivalents) or other immunosuppressive medications within 14 days of study treatment administration\n * Participants with a known history of testing positive for Human Immunodeficiency Virus (HIV) or known Acquired Immunodeficiency Syndrome (AIDS)\n * Cytotoxic agents, unless at least 4 weeks have elapsed from last dose of prior anti-cancer therapy and initiation of study therapy\n\nOther protocol defined inclusion/exclusion criteria could apply",{"$nulls":4},"Actual","2018-01-17","Actual","Anticipated","2023-03-01","Anticipated","2018-04-01","2018-01-12","2018-01-12","2018-04-30",null,null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No",null,null,"URL: http://bms.com/studyconnect/Pages/home.aspx [http://bms.com/studyconnect/Pages/home.aspx] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: BMS Clinical Trial Patient Recruiting",null,"Yes","No",{"$nulls":19},"Incidence of adverse events (AE)|Incidence of serious adverse events (SAE)|Incidence of AEs meeting protocol-defined dose limiting toxicities (DLT) criteria|Incidence of AEs leading to discontinuation|Incidence of deaths|Incidence of labornatory abnormalities","Approximately 5 years",null,"Overall response rate (ORR)|Median duration of response (mDOR)|Incidence of anti-drug antibody (ADA) to BMS-986253|Serum biomarker concentration|Maximum observed serum concentration (Cmax)|Time of maximum observed serum concentration (Tmax)|Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]|Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)]|Observed serum concentration at the end of a dosing interval (CTAU)|Trough observed serum concentration at the end of the dosing interval (CTROUGH)","Approximately 5 years",null,"Clinical.Trials@bms.com","Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,","please email:","Denver, Colorado, United States, 80218|Baltimore, Maryland, United States, 21287|Ann Arbor, Michigan, United States, 48109|Las Vegas, Nevada, United States, 89169|Hackensack, New Jersey, United States, 07601|New York, New York, United States, 10032|Eugene, Oregon, United States, 97401|Pittsburgh, Pennsylvania, United States, 15213|Greenville, South Carolina, United States, 29605|Austin, Texas, United States, 78705|Fairfax, Virginia, United States, 22031","Colorado|Maryland|Michigan|Nevada|New Jersey|New York|Oregon|Pennsylvania|South Carolina|Texas|Virginia","United States","Local Institution|John Theurer Cancer Center At Hackensack University Medical Center|Columbia University Medical Center (Cumc)|Upmc Cancer Center",null,"First line of the email MUST contain NCT # and Site #.",null,"Bristol-Myers Squibb","2018-04-30","2020-05-25T16:37:03.571","2020-05-26T17:10:42.972","NCT03400332"]
["5ecbf42fe2561b1b11905d6f","NCT03400332","2018-05-17","Bristol-Myers Squibb","BMY","Recruiting","An Investigational Immuno-Therapy Study of Experimental Medication BMS-986253 Given in Combination With Nivolumab in Patients With Advanced Cancers","Bms-986253|Nivolumab","IL8 Inhibitor|PD-1 Inhibitor","Yes","['Bms-986253']","No",null,"Phase 1/Phase 2",2,260,"Anticipated","2018-01-31","2023-02-28","DLT","Dose Limiting Toxicity",{"$nulls":3},"The purpose of this study is to investigate experimental medication BMS-986253 in combination with Nivolumab in patients with advanced cancers.",null,"A Phase 1/2a Study of BMS-986253 in Combination With Nivolumab in Advanced Cancers","CA027-002","Cancer","Oncology Unspecified","Oncology Unspecified","Oncology","Experimental","Dose Finding|Dose Expansion","BMS-986253 administered in combination with Nivolumab","Drug|Biological","BMS-986253|Nivolumab","Specified dose on specified days","BMS-936558 | Opdivo","Dose Finding|Dose Expansion","\n\n * Histologic or cytologic confirmation of a solid tumor that is advanced (metastatic, recurrent and/or unresectable) with measurable disease per RECIST v1.1\n * At least 1 lesion accessible for biopsy\n * Eastern Cooperative Oncology Group Performance Status of 0 or 1\n\n","\n\n * Participants with primary central nervous system (CNS) tumors, or with CNS metastases as the only site of active disease (Participants with controlled brain metastases; however, will be allowed to enroll)\n * Participants with active, known or suspected autoimmune disease\n * Participants with conditions requiring systemic treatment with either corticosteroids (> 10mg prednisone equivalents) or other immunosuppressive medications within 14 days of study treatment administration\n * Participants with a known history of testing positive for Human Immunodeficiency Virus (HIV) or known Acquired Immunodeficiency Syndrome (AIDS)\n * Cytotoxic agents, unless at least 4 weeks have elapsed from last dose of prior anti-cancer therapy and initiation of study therapy\n\nOther protocol defined inclusion/exclusion criteria could apply",{"$nulls":4},"Actual","2018-01-17","Actual","Anticipated","2023-03-01","Anticipated","2018-05-01","2018-01-12","2018-01-12","2018-05-16",null,null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No",null,null,"URL: http://bms.com/studyconnect/Pages/home.aspx [http://bms.com/studyconnect/Pages/home.aspx] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: BMS Clinical Trial Patient Recruiting",null,"Yes","No",{"$nulls":19},"Incidence of adverse events (AE)|Incidence of serious adverse events (SAE)|Incidence of AEs meeting protocol-defined dose limiting toxicities (DLT) criteria|Incidence of AEs leading to discontinuation|Incidence of deaths|Incidence of labornatory abnormalities","Approximately 5 years",null,"Overall response rate (ORR)|Median duration of response (mDOR)|Incidence of anti-drug antibody (ADA) to BMS-986253|Serum biomarker concentration|Maximum observed serum concentration (Cmax)|Time of maximum observed serum concentration (Tmax)|Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]|Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)]|Observed serum concentration at the end of a dosing interval (CTAU)|Trough observed serum concentration at the end of the dosing interval (CTROUGH)","Approximately 5 years",null,"Clinical.Trials@bms.com","Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,","please email:","Denver, Colorado, United States, 80218|Baltimore, Maryland, United States, 21287|Ann Arbor, Michigan, United States, 48109|Las Vegas, Nevada, United States, 89169|Hackensack, New Jersey, United States, 07601|New York, New York, United States, 10032|Eugene, Oregon, United States, 97401|Pittsburgh, Pennsylvania, United States, 15213|Greenville, South Carolina, United States, 29605|Austin, Texas, United States, 78705|Fairfax, Virginia, United States, 22031","Colorado|Maryland|Michigan|Nevada|New Jersey|New York|Oregon|Pennsylvania|South Carolina|Texas|Virginia","United States","Rocky Mountain Cancer Centers|Local Institution|John Theurer Cancer Center At Hackensack University Medical Center|Columbia University Medical Center (Cumc)|Upmc Cancer Center|Texas Oncology",null,"First line of the email MUST contain NCT # and Site #.",null,"Bristol-Myers Squibb","2018-05-16","2020-05-25T16:37:03.353","2020-05-26T17:10:42.972","NCT03400332"]
["5ecbf42f11702c1b1b916a85","NCT03400332","2018-07-24","Bristol-Myers Squibb","BMY","Recruiting","An Investigational Immuno-Therapy Study of Experimental Medication BMS-986253 Given in Combination With Nivolumab in Patients With Advanced Cancers","Bms-986253|Nivolumab","IL8 Inhibitor|PD-1 Inhibitor","Yes","['Bms-986253']","No",null,"Phase 1/Phase 2",2,260,"Anticipated","2018-01-31","2023-02-28","DLT","Dose Limiting Toxicity",{"$nulls":3},"The purpose of this study is to investigate experimental medication BMS-986253 in combination with Nivolumab in patients with advanced cancers.",null,"A Phase 1/2a Study of BMS-986253 in Combination With Nivolumab in Advanced Cancers","CA027-002","Cancer","Oncology Unspecified","Oncology Unspecified","Oncology","Experimental","Dose Finding|Dose Expansion","BMS-986253 administered in combination with Nivolumab","Drug|Biological","BMS-986253|Nivolumab","Specified dose on specified days","BMS-936558 | Opdivo","Dose Finding|Dose Expansion","\n\n * Histologic or cytologic confirmation of a solid tumor that is advanced (metastatic, recurrent and/or unresectable) with measurable disease per RECIST v1.1\n * At least 1 lesion accessible for biopsy\n * Eastern Cooperative Oncology Group Performance Status of 0 or 1\n\n","\n\n * Participants with primary central nervous system (CNS) tumors, or with CNS metastases as the only site of active disease (Participants with controlled brain metastases; however, will be allowed to enroll)\n * Participants with active, known or suspected autoimmune disease\n * Participants with conditions requiring systemic treatment with either corticosteroids (> 10mg prednisone equivalents) or other immunosuppressive medications within 14 days of study treatment administration\n * Participants with a known history of testing positive for Human Immunodeficiency Virus (HIV) or known Acquired Immunodeficiency Syndrome (AIDS)\n * Cytotoxic agents, unless at least 4 weeks have elapsed from last dose of prior anti-cancer therapy and initiation of study therapy\n\nOther protocol defined inclusion/exclusion criteria could apply",{"$nulls":4},"Actual","2018-01-17","Actual","Anticipated","2023-03-01","Anticipated","2018-07-01","2018-01-12","2018-01-12","2018-07-23",null,null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No",null,null,"URL: http://bms.com/studyconnect/Pages/home.aspx [http://bms.com/studyconnect/Pages/home.aspx] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: BMS Clinical Trial Patient Recruiting",null,"Yes","No",{"$nulls":19},"Incidence of adverse events (AE)|Incidence of serious adverse events (SAE)|Incidence of AEs meeting protocol-defined dose limiting toxicities (DLT) criteria|Incidence of AEs leading to discontinuation|Incidence of deaths|Incidence of labornatory abnormalities","Approximately 5 years",null,"Overall response rate (ORR)|Median duration of response (mDOR)|Incidence of anti-drug antibody (ADA) to BMS-986253|Serum biomarker concentration|Maximum observed serum concentration (Cmax)|Time of maximum observed serum concentration (Tmax)|Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]|Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)]|Observed serum concentration at the end of a dosing interval (CTAU)|Trough observed serum concentration at the end of the dosing interval (CTROUGH)","Approximately 5 years",null,"Clinical.Trials@bms.com","Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,","please email:","Toronto, Ontario, Canada, M5G 1Z5|Birmingham, West Midlands, United Kingdom, B15 2Th|Denver, Colorado, United States, 80218|Lutherville, Maryland, United States, 21093|Ann Arbor, Michigan, United States, 48109|Las Vegas, Nevada, United States, 89169|Hackensack, New Jersey, United States, 07601|New York, New York, United States, 10029|Eugene, Oregon, United States, 97401|Pittsburgh, Pennsylvania, United States, 15213|Greenville, South Carolina, United States, 29605|Austin, Texas, United States, 78705|Fairfax, Virginia, United States, 22031","Colorado|Maryland|Michigan|Nevada|New Jersey|New York|Oregon|Pennsylvania|South Carolina|Texas|Virginia","Canada|United Kingdom|United States","Ontario Local Institution|, West Midlands Local Institution|Rocky Mountain Cancer Centers|Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins|Local Institution|Comprehensive Cancer Centers Of Nevada|John Theurer Cancer Center At Hackensack University Medical Center|Willamette Valley Cancer Institute And Research Center|Upmc Cancer Center|Greenville Health System|Texas Oncology|Virginia Cancer Specialists, Pc",null,"First line of the email MUST contain NCT # and Site #.",null,"Bristol-Myers Squibb","2018-07-23","2020-05-25T16:37:03.748","2020-05-26T17:10:42.972","NCT03400332"]
["5ecbf42f307e3d1b1f8d9d06","NCT03400332","2018-08-29","Bristol-Myers Squibb","BMY","Recruiting","An Investigational Immuno-Therapy Study of Experimental Medication BMS-986253 Given in Combination With Nivolumab in Patients With Advanced Cancers","Bms-986253|Nivolumab","IL8 Inhibitor|PD-1 Inhibitor","Yes","['Bms-986253']","No",null,"Phase 1/Phase 2",2,260,"Anticipated","2018-01-31","2023-02-28","DLT","Dose Limiting Toxicity",{"$nulls":3},"The purpose of this study is to investigate experimental medication BMS-986253 in combination with Nivolumab in patients with advanced cancers.",null,"A Phase 1/2a Study of BMS-986253 in Combination With Nivolumab in Advanced Cancers","CA027-002","Cancer","Oncology Unspecified","Oncology Unspecified","Oncology","Experimental","Dose Finding|Dose Expansion","BMS-986253 administered in combination with Nivolumab","Drug|Biological","BMS-986253|Nivolumab","Specified dose on specified days","BMS-936558 | Opdivo","Dose Finding|Dose Expansion","\n\n * Histologic or cytologic confirmation of a solid tumor that is advanced (metastatic, recurrent and/or unresectable) with measurable disease per RECIST v1.1\n * At least 1 lesion accessible for biopsy\n * Eastern Cooperative Oncology Group Performance Status of 0 or 1\n\n","\n\n * Participants with primary central nervous system (CNS) tumors, or with CNS metastases as the only site of active disease (Participants with controlled brain metastases; however, will be allowed to enroll)\n * Participants with active, known or suspected autoimmune disease\n * Participants with conditions requiring systemic treatment with either corticosteroids (> 10mg prednisone equivalents) or other immunosuppressive medications within 14 days of study treatment administration\n * Participants with a known history of testing positive for Human Immunodeficiency Virus (HIV) or known Acquired Immunodeficiency Syndrome (AIDS)\n * Cytotoxic agents, unless at least 4 weeks have elapsed from last dose of prior anti-cancer therapy and initiation of study therapy\n\nOther protocol defined inclusion/exclusion criteria could apply",{"$nulls":4},"Actual","2018-01-17","Actual","Anticipated","2023-03-01","Anticipated","2018-08-01","2018-01-12","2018-01-12","2018-08-27",null,null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No",null,null,"URL: https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html [https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: BMS Clinical Trial Information",null,"Yes","No",{"$nulls":19},"Incidence of adverse events (AE)|Incidence of serious adverse events (SAE)|Incidence of AEs meeting protocol-defined dose limiting toxicities (DLT) criteria|Incidence of AEs leading to discontinuation|Incidence of deaths|Incidence of labornatory abnormalities","Approximately 5 years",null,"Overall response rate (ORR)|Median duration of response (mDOR)|Incidence of anti-drug antibody (ADA) to BMS-986253|Serum biomarker concentration|Maximum observed serum concentration (Cmax)|Time of maximum observed serum concentration (Tmax)|Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]|Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)]|Observed serum concentration at the end of a dosing interval (CTAU)|Trough observed serum concentration at the end of the dosing interval (CTROUGH)","Approximately 5 years",null,"Clinical.Trials@bms.com","Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,","please email:","Edmonton, Alberta, Canada, T6G 1Z2|Vancouver, British Columbia, Canada, V5Z 4E6|Toronto, Ontario, Canada, M5G 1Z5|Birmingham, West Midlands, United Kingdom, B15 2Th|Denver, Colorado, United States, 80218|Lutherville, Maryland, United States, 21093|Ann Arbor, Michigan, United States, 48109|Las Vegas, Nevada, United States, 89169|Hackensack, New Jersey, United States, 07601|New York, New York, United States, 10029|Oklahoma City, Oklahoma, United States, 73104|Eugene, Oregon, United States, 97401|Philadelphia, Pennsylvania, United States, 19111|Greenville, South Carolina, United States, 29605|Austin, Texas, United States, 78705|Fairfax, Virginia, United States, 22031","Colorado|Maryland|Michigan|Nevada|New Jersey|New York|Oklahoma|Oregon|Pennsylvania|South Carolina|Texas|Virginia","Canada|United Kingdom|United States","Alberta Local Institution|British Columbia Local Institution|Ontario Local Institution|, West Midlands Local Institution|Rocky Mountain Cancer Centers|Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins|Local Institution|Comprehensive Cancer Centers Of Nevada|John Theurer Cancer Center At Hackensack University Medical Center|Willamette Valley Cancer Institute And Research Center|Greenville Health System|Texas Oncology|Virginia Cancer Specialists, Pc",null,"First line of the email MUST contain NCT # and Site #.",null,"Bristol-Myers Squibb","2018-08-27","2020-05-25T16:37:03.939","2020-05-26T17:10:42.972","NCT03400332"]
["5ecbf430e2561b1b11905d71","NCT03400332","2019-01-31","Bristol-Myers Squibb","BMY","Recruiting","An Investigational Immuno-Therapy Study of Experimental Medication BMS-986253 Given in Combination With Nivolumab in Patients With Advanced Cancers","Bms-986253|Nivolumab","IL8 Inhibitor|PD-1 Inhibitor","Yes","['Bms-986253']","No",null,"Phase 1/Phase 2",2,280,"Anticipated","2018-01-31","2023-02-28","DLT","Dose Limiting Toxicity",{"$nulls":3},"The purpose of this study is to investigate experimental medication BMS-986253 in combination with Nivolumab in patients with advanced cancers.",null,"A Phase 1/2a Study of BMS-986253 in Combination With Nivolumab in Advanced Cancers","CA027-002","Cancer","Oncology Unspecified","Oncology Unspecified","Oncology","Experimental","Dose Finding|Dose Expansion","BMS-986253 administered in combination with Nivolumab","Drug|Biological","BMS-986253|Nivolumab","Specified dose on specified days","BMS-936558 | Opdivo","Dose Finding|Dose Expansion","\n\n * Histologic or cytologic confirmation of a solid tumor that is advanced (metastatic, recurrent and/or unresectable) with measurable disease per RECIST v1.1\n * At least 1 lesion accessible for biopsy\n * Eastern Cooperative Oncology Group Performance Status of 0 or 1\n\n","\n\n * Participants with CNS metastases as the only site of active disease (Participants with controlled brain metastases; however, will be allowed to enroll)\n * Participants with active, known or suspected autoimmune disease\n * Participants with conditions requiring systemic treatment with either corticosteroids (> 10mg prednisone equivalents) or other immunosuppressive medications within 14 days of study treatment administration\n * Participants with a known history of testing positive for Human Immunodeficiency Virus (HIV) or known Acquired Immunodeficiency Syndrome (AIDS)\n * Cytotoxic agents, unless at least 4 weeks have elapsed from last dose of prior anti-cancer therapy and initiation of study therapy\n\nOther protocol defined inclusion/exclusion criteria could apply",{"$nulls":4},"Actual","2018-01-17","Actual","Anticipated","2023-03-01","Anticipated","2019-01-01","2018-01-12","2018-01-12","2019-01-30",null,null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No",null,null,"URL: https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html [https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: BMS Clinical Trial Information",null,"Yes","No",{"$nulls":19},"Incidence of adverse events (AE)|Incidence of serious adverse events (SAE)|Incidence of AEs meeting protocol-defined dose limiting toxicities (DLT) criteria|Incidence of AEs leading to discontinuation|Incidence of deaths|Incidence of labornatory abnormalities","Approximately 5 years",null,"Overall response rate (ORR)|Median duration of response (mDOR)|Incidence of anti-drug antibody (ADA) to BMS-986253|Serum biomarker concentration|Maximum observed serum concentration (Cmax)|Time of maximum observed serum concentration (Tmax)|Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]|Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)]|Observed serum concentration at the end of a dosing interval (CTAU)|Trough observed serum concentration at the end of the dosing interval (CTROUGH)","Approximately 5 years",null,"Clinical.Trials@bms.com","Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,","please email:","Bruxelles, Belgium, 1200|Edmonton, Alberta, Canada, T6G 1Z2|Vancouver, British Columbia, Canada, V5Z 4E6|Toronto, Ontario, Canada, M5G 1Z5|Napoli, Italy, 80131|Madrid, Spain, 28034|Manchester, Greater Manchester, United Kingdom, M20 4Bx|Birmingham, West Midlands, United Kingdom, B15 2Th|Denver, Colorado, United States, 80218|Miami Beach, Florida, United States, 33140|Lutherville, Maryland, United States, 21093|Ann Arbor, Michigan, United States, 48109|Las Vegas, Nevada, United States, 89169|Hackensack, New Jersey, United States, 07601|New York, New York, United States, 10029|Oklahoma City, Oklahoma, United States, 73104|Eugene, Oregon, United States, 97401|Philadelphia, Pennsylvania, United States, 19111|Greenville, South Carolina, United States, 29605|Austin, Texas, United States, 78705|Fairfax, Virginia, United States, 22031","Colorado|Florida|Maryland|Michigan|Nevada|New Jersey|New York|Oklahoma|Oregon|Pennsylvania|South Carolina|Texas|Virginia","Belgium|Canada|Italy|Spain|United Kingdom|United States","Local Institution|Alberta Local Institution|British Columbia Local Institution|Ontario Local Institution|Istituto Nazionale Tumori Fondazione Pascale|, Greater Manchester Local Institution|, West Midlands Local Institution|Rocky Mountain Cancer Centers|Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins|University Of Michigan Health System|Comprehensive Cancer Centers Of Nevada|John Theurer Cancer Center At Hackensack University Medical Center|Icahn School Of Medicine At Mount Sinai|Stephenson Cancer Center|Willamette Valley Cancer Institute And Research Center|Greenville Health System|Texas Oncology|Virginia Cancer Specialists, Pc",null,"First line of the email MUST contain NCT # and Site #.",null,"Bristol-Myers Squibb","2019-01-30","2020-05-25T16:37:04.270","2020-05-26T17:10:42.972","NCT03400332"]
["5ecbf43011702c1b1b916a86","NCT03400332","2019-04-22","Bristol-Myers Squibb","BMY","Recruiting","An Investigational Immuno-Therapy Study of Experimental Medication BMS-986253 Given in Combination With Nivolumab in Patients With Advanced Cancers","Bms-986253|Nivolumab","IL8 Inhibitor|PD-1 Inhibitor","Yes","['Bms-986253']","No",null,"Phase 1/Phase 2",2,280,"Anticipated","2018-01-31","2023-11-26","DLT","Dose Limiting Toxicity",{"$nulls":3},"The purpose of this study is to investigate experimental medication BMS-986253 in combination with Nivolumab in patients with advanced cancers.",null,"A Phase 1/2a Study of BMS-986253 in Combination With Nivolumab in Advanced Cancers","CA027-002","Cancer","Oncology Unspecified","Oncology Unspecified","Oncology","Experimental","Dose Finding|Dose Expansion","BMS-986253 administered in combination with Nivolumab","Drug|Biological","BMS-986253|Nivolumab","Specified dose on specified days","BMS-936558 | Opdivo","Dose Finding|Dose Expansion","\n\n * Histologic or cytologic confirmation of a solid tumor that is advanced (metastatic, recurrent and/or unresectable) with measurable disease per RECIST v1.1\n * At least 1 lesion accessible for biopsy\n * Eastern Cooperative Oncology Group Performance Status of 0 or 1\n\n","\n\n * Participants with CNS metastases as the only site of active disease (Participants with controlled brain metastases; however, will be allowed to enroll)\n * Participants with active, known or suspected autoimmune disease\n * Participants with conditions requiring systemic treatment with either corticosteroids (> 10mg prednisone equivalents) or other immunosuppressive medications within 14 days of study treatment administration\n * Participants with a known history of testing positive for Human Immunodeficiency Virus (HIV) or known Acquired Immunodeficiency Syndrome (AIDS)\n * Cytotoxic agents, unless at least 4 weeks have elapsed from last dose of prior anti-cancer therapy and initiation of study therapy\n\nOther protocol defined inclusion/exclusion criteria could apply",{"$nulls":4},"Actual","2018-01-17","Actual","Anticipated","2023-11-26","Anticipated","2019-04-01","2018-01-12","2018-01-12","2019-04-18",null,null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No",null,null,"URL: https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html [https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: BMS Clinical Trial Information",null,"Yes","No",{"$nulls":19},"Incidence of adverse events (AE)|Incidence of serious adverse events (SAE)|Incidence of AEs meeting protocol-defined dose limiting toxicities (DLT) criteria|Incidence of AEs leading to discontinuation|Incidence of deaths|Incidence of labornatory abnormalities","Approximately 5 years",null,"Overall response rate (ORR)|Median duration of response (mDOR)|Incidence of anti-drug antibody (ADA) to BMS-986253|Serum biomarker concentration|Maximum observed serum concentration (Cmax)|Time of maximum observed serum concentration (Tmax)|Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]|Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)]|Observed serum concentration at the end of a dosing interval (CTAU)|Trough observed serum concentration at the end of the dosing interval (CTROUGH)","Approximately 5 years",null,"Clinical.Trials@bms.com","Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,","please email:","Bruxelles, Belgium, 1200|Edmonton, Alberta, Canada, T6G 1Z2|Vancouver, British Columbia, Canada, V5Z 4E6|Toronto, Ontario, Canada, M5G 1Z5|Berlin, Germany, 12200|Napoli, Italy, 80131|Madrid, Spain, 28034|Lausanne, Switzerland, 1011|Manchester, Greater Manchester, United Kingdom, M20 4Bx|Birmingham, West Midlands, United Kingdom, B15 2Th|Denver, Colorado, United States, 80218|Miami Beach, Florida, United States, 33140|Lutherville, Maryland, United States, 21093|Ann Arbor, Michigan, United States, 48109|Las Vegas, Nevada, United States, 89169|Hackensack, New Jersey, United States, 07601|New York, New York, United States, 10029|Oklahoma City, Oklahoma, United States, 73104|Eugene, Oregon, United States, 97401|Philadelphia, Pennsylvania, United States, 19111|Greenville, South Carolina, United States, 29605|Austin, Texas, United States, 78705|Fairfax, Virginia, United States, 22031","Colorado|Florida|Maryland|Michigan|Nevada|New Jersey|New York|Oklahoma|Oregon|Pennsylvania|South Carolina|Texas|Virginia","Belgium|Canada|Germany|Italy|Spain|Switzerland|United Kingdom|United States","Local Institution|Alberta Local Institution|British Columbia Local Institution|Ontario Local Institution|Istituto Nazionale Tumori Fondazione Pascale|Hospital Universitario Ramon Y Cajal|, Greater Manchester Local Institution|, West Midlands Local Institution|Rocky Mountain Cancer Centers|Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins|University Of Michigan Health System|Comprehensive Cancer Centers Of Nevada|John Theurer Cancer Center At Hackensack University Medical Center|Icahn School Of Medicine At Mount Sinai|Stephenson Cancer Center|Willamette Valley Cancer Institute And Research Center|Greenville Health System|Texas Oncology|Virginia Cancer Specialists, Pc",null,"First line of the email MUST contain NCT # and Site #.",null,"Bristol-Myers Squibb","2019-04-18","2020-05-25T16:37:04.207","2020-05-26T17:10:42.972","NCT03400332"]
["5ecbf430feab101b155308a7","NCT03400332","2019-09-11","Bristol-Myers Squibb","BMY","Recruiting","An Investigational Immuno-Therapy Study of Experimental Medication BMS-986253 Given in Combination With Nivolumab in Patients With Advanced Cancers","Bms-986253|Nivolumab","IL8 Inhibitor|PD-1 Inhibitor","Yes","['Bms-986253']","No",null,"Phase 1/Phase 2",2,320,"Anticipated","2018-01-31","2023-11-26","DLT","Dose Limiting Toxicity",{"$nulls":3},"The purpose of this study is to investigate experimental medication BMS-986253 in combination with Nivolumab in patients with advanced cancers.",null,"A Phase 1/2a Study of BMS-986253 in Combination With Nivolumab in Advanced Cancers","CA027-002","Cancer","Oncology Unspecified","Oncology Unspecified","Oncology","Experimental","Dose Finding|Dose Expansion","BMS-986253 administered in combination with Nivolumab","Drug|Biological","BMS-986253|Nivolumab","Specified dose on specified days","BMS-936558 | Opdivo","Dose Finding|Dose Expansion","\n\n * Histologic or cytologic confirmation of a solid tumor that is advanced (metastatic, recurrent and/or unresectable) with measurable disease per RECIST v1.1\n * At least 1 lesion accessible for biopsy\n * Eastern Cooperative Oncology Group Performance Status of 0 or 1\n\n","\n\n * Participants with CNS metastases as the only site of active disease (Participants with controlled brain metastases; however, will be allowed to enroll)\n * Participants with active, known or suspected autoimmune disease\n * Participants with conditions requiring systemic treatment with either corticosteroids (> 10mg prednisone equivalents) or other immunosuppressive medications within 14 days of study treatment administration\n * Participants with a known history of testing positive for Human Immunodeficiency Virus (HIV) or known Acquired Immunodeficiency Syndrome (AIDS)\n * Cytotoxic agents, unless at least 4 weeks have elapsed from last dose of prior anti-cancer therapy and initiation of study therapy\n\nOther protocol defined inclusion/exclusion criteria could apply",{"$nulls":4},"Actual","2018-01-17","Actual","Anticipated","2023-11-26","Anticipated","2019-09-01","2018-01-12","2018-01-12","2019-09-10","No",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No",null,null,"URL: https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html [https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: BMS Clinical Trial Information",null,"Yes","No",{"$nulls":19},"Incidence of adverse events (AE)|Incidence of serious adverse events (SAE)|Incidence of AEs meeting protocol-defined dose limiting toxicities (DLT) criteria|Incidence of AEs leading to discontinuation|Incidence of deaths|Incidence of labornatory abnormalities","Approximately 5 years",null,"Overall response rate (ORR)|Median duration of response (mDOR)|Incidence of anti-drug antibody (ADA) to BMS-986253|Serum biomarker concentration|Maximum observed serum concentration (Cmax)|Time of maximum observed serum concentration (Tmax)|Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]|Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)]|Observed serum concentration at the end of a dosing interval (CTAU)|Trough observed serum concentration at the end of the dosing interval (CTROUGH)","Approximately 5 years",null,"Clinical.Trials@bms.com","Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,","please email:","Bruxelles, Belgium, 1200|Edmonton, Alberta, Canada, T6G 1Z2|Vancouver, British Columbia, Canada, V5Z 4E6|Toronto, Ontario, Canada, M5G 1Z5|Berlin, Germany, 12200|Napoli, Italy, 80131|Madrid, Spain, 28034|Lausanne, Switzerland, 1011|Manchester, Greater Manchester, United Kingdom, M20 4Bx|Birmingham, West Midlands, United Kingdom, B15 2Th|Denver, Colorado, United States, 80218|Miami Beach, Florida, United States, 33140|Lutherville, Maryland, United States, 21093|Ann Arbor, Michigan, United States, 48109|Las Vegas, Nevada, United States, 89169|Hackensack, New Jersey, United States, 07601|New York, New York, United States, 10029|Oklahoma City, Oklahoma, United States, 73104|Eugene, Oregon, United States, 97401|Philadelphia, Pennsylvania, United States, 19111|Greenville, South Carolina, United States, 29605|Austin, Texas, United States, 78705|Fairfax, Virginia, United States, 22031","Colorado|Florida|Maryland|Michigan|Nevada|New Jersey|New York|Oklahoma|Oregon|Pennsylvania|South Carolina|Texas|Virginia","Belgium|Canada|Germany|Italy|Spain|Switzerland|United Kingdom|United States","Local Institution|Alberta Local Institution|British Columbia Local Institution|Ontario Local Institution|Istituto Nazionale Tumori Fondazione Pascale|Hospital Universitario Ramon Y Cajal|Chu Vaudois Lausanne|, Greater Manchester Local Institution|, West Midlands Local Institution|Rocky Mountain Cancer Centers|Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins|University Of Michigan Health System|Comprehensive Cancer Centers Of Nevada|John Theurer Cancer Center At Hackensack University Medical Center|Icahn School Of Medicine At Mount Sinai|Stephenson Cancer Center|Willamette Valley Cancer Institute And Research Center|Greenville Health System|Texas Oncology|Virginia Cancer Specialists, Pc",null,"First line of the email MUST contain NCT # and Site #.",null,"Bristol-Myers Squibb","2019-09-10","2020-05-25T16:37:04.439","2020-05-26T17:10:42.972","NCT03400332"]
["5ecbf430feab101b155308a8","NCT03400332","2019-09-26","Bristol-Myers Squibb","BMY","Recruiting","An Investigational Immuno-Therapy Study of Experimental Medication BMS-986253 Given in Combination With Nivolumab in Patients With Advanced Cancers","Bms-986253|Nivolumab","IL8 Inhibitor|PD-1 Inhibitor","Yes","['Bms-986253']","No",null,"Phase 1/Phase 2",2,320,"Anticipated","2018-01-31","2023-11-26","DLT","Dose Limiting Toxicity",{"$nulls":3},"The purpose of this study is to investigate experimental medication BMS-986253 in combination with Nivolumab in patients with advanced cancers.",null,"A Phase 1/2a Study of BMS-986253 in Combination With Nivolumab in Advanced Cancers","CA027-002","Cancer","Oncology Unspecified","Oncology Unspecified","Oncology","Experimental","Dose Finding|Dose Expansion","BMS-986253 administered in combination with Nivolumab","Drug|Biological","BMS-986253|Nivolumab","Specified dose on specified days","BMS-936558 | Opdivo","Dose Finding|Dose Expansion","\n\n * Histologic or cytologic confirmation of a solid tumor that is advanced (metastatic, recurrent and/or unresectable) with measurable disease per RECIST v1.1\n * At least 1 lesion accessible for biopsy\n * Eastern Cooperative Oncology Group Performance Status of 0 or 1\n\n","\n\n * Participants with CNS metastases as the only site of active disease (Participants with controlled brain metastases; however, will be allowed to enroll)\n * Participants with active, known or suspected autoimmune disease\n * Participants with conditions requiring systemic treatment with either corticosteroids (> 10mg prednisone equivalents) or other immunosuppressive medications within 14 days of study treatment administration\n * Participants with a known history of testing positive for Human Immunodeficiency Virus (HIV) or known Acquired Immunodeficiency Syndrome (AIDS)\n * Cytotoxic agents, unless at least 4 weeks have elapsed from last dose of prior anti-cancer therapy and initiation of study therapy\n\nOther protocol defined inclusion/exclusion criteria could apply",{"$nulls":4},"Actual","2018-01-17","Actual","Anticipated","2023-11-26","Anticipated","2019-09-01","2018-01-12","2018-01-12","2019-09-25","No",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No",null,null,"URL: https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html [https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: BMS Clinical Trial Information",null,"Yes","No",{"$nulls":19},"Incidence of adverse events (AE)|Incidence of serious adverse events (SAE)|Incidence of AEs meeting protocol-defined dose limiting toxicities (DLT) criteria|Incidence of AEs leading to discontinuation|Incidence of deaths|Incidence of labornatory abnormalities","Approximately 5 years",null,"Overall response rate (ORR)|Median duration of response (mDOR)|Incidence of anti-drug antibody (ADA) to BMS-986253|Serum biomarker concentration|Maximum observed serum concentration (Cmax)|Time of maximum observed serum concentration (Tmax)|Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]|Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)]|Observed serum concentration at the end of a dosing interval (CTAU)|Trough observed serum concentration at the end of the dosing interval (CTROUGH)","Approximately 5 years",null,"Clinical.Trials@bms.com","Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,","please email:","Bruxelles, Belgium, 1200|Edmonton, Alberta, Canada, T6G 1Z2|Vancouver, British Columbia, Canada, V5Z 4E6|Toronto, Ontario, Canada, M5G 1Z5|Berlin, Germany, 12200|Napoli, Italy, 80131|Madrid, Spain, 28034|Lausanne, Switzerland, 1011|Manchester, Greater Manchester, United Kingdom, M20 4Bx|Birmingham, West Midlands, United Kingdom, B15 2Th|Denver, Colorado, United States, 80218|Miami Beach, Florida, United States, 33140|Lutherville, Maryland, United States, 21093|Ann Arbor, Michigan, United States, 48109|Las Vegas, Nevada, United States, 89169|Hackensack, New Jersey, United States, 07601|New York, New York, United States, 10029|Oklahoma City, Oklahoma, United States, 73104|Eugene, Oregon, United States, 97401|Philadelphia, Pennsylvania, United States, 19111|Greenville, South Carolina, United States, 29605|Austin, Texas, United States, 78705|Fairfax, Virginia, United States, 22031","Colorado|Florida|Maryland|Michigan|Nevada|New Jersey|New York|Oklahoma|Oregon|Pennsylvania|South Carolina|Texas|Virginia","Belgium|Canada|Germany|Italy|Spain|Switzerland|United Kingdom|United States","Local Institution|Alberta Local Institution|British Columbia Local Institution|Ontario Local Institution|Istituto Nazionale Tumori Fondazione Pascale|Hospital Universitario Ramon Y Cajal|Chu Vaudois Lausanne|, Greater Manchester Local Institution|, West Midlands Local Institution|Rocky Mountain Cancer Centers|Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins|University Of Michigan Health System|Comprehensive Cancer Centers Of Nevada|John Theurer Cancer Center At Hackensack University Medical Center|Icahn School Of Medicine At Mount Sinai|Stephenson Cancer Center|Willamette Valley Cancer Institute And Research Center|Greenville Health System|Texas Oncology|Virginia Cancer Specialists, Pc",null,"First line of the email MUST contain NCT # and Site #.",null,"Bristol-Myers Squibb","2019-09-25","2020-05-25T16:37:04.860","2020-05-26T17:10:42.972","NCT03400332"]
["5ecbf430fe30261b1a048277","NCT03400332","2020-02-12","Bristol-Myers Squibb","BMY","Recruiting","An Investigational Immuno-Therapy Study of Experimental Medication BMS-986253 Given in Combination With Nivolumab in Patients With Advanced Cancers","Bms-986253|Nivolumab","IL8 Inhibitor|PD-1 Inhibitor","Yes","['Bms-986253']","No",null,"Phase 1/Phase 2",2,320,"Anticipated","2018-01-31","2023-11-26","DLT","Dose Limiting Toxicity",{"$nulls":3},"The purpose of this study is to investigate experimental medication BMS-986253 in combination with Nivolumab in patients with advanced cancers.",null,"A Phase 1/2a Study of BMS-986253 in Combination With Nivolumab in Advanced Cancers","CA027-002","Cancer","Oncology Unspecified","Oncology Unspecified","Oncology","Experimental","Dose Finding|Dose Expansion","BMS-986253 administered in combination with Nivolumab","Drug|Biological","BMS-986253|Nivolumab","Specified dose on specified days","BMS-936558 | Opdivo","Dose Finding|Dose Expansion","\n\n * Histologic or cytologic confirmation of a solid tumor that is advanced (metastatic, recurrent and/or unresectable) with measurable disease per RECIST v1.1\n * At least 1 lesion accessible for biopsy\n * Eastern Cooperative Oncology Group Performance Status of 0 or 1\n\n","\n\n * Participants with CNS metastases as the only site of active disease (Participants with controlled brain metastases; however, will be allowed to enroll)\n * Participants with active, known or suspected autoimmune disease\n * Participants with conditions requiring systemic treatment with either corticosteroids (> 10mg prednisone equivalents) or other immunosuppressive medications within 14 days of study treatment administration\n * Participants with a known history of testing positive for Human Immunodeficiency Virus (HIV) or known Acquired Immunodeficiency Syndrome (AIDS)\n * Cytotoxic agents, unless at least 4 weeks have elapsed from last dose of prior anti-cancer therapy and initiation of study therapy\n\nOther protocol defined inclusion/exclusion criteria could apply",{"$nulls":4},"Actual","2018-01-17","Actual","Anticipated","2023-11-26","Anticipated","2020-02-01","2018-01-12","2018-01-12","2020-02-11","No",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No",null,null,"URL: https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html [https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: BMS Clinical Trial Information",null,"Yes","No",{"$nulls":19},"Incidence of adverse events (AE)|Incidence of serious adverse events (SAE)|Incidence of AEs meeting protocol-defined dose limiting toxicities (DLT) criteria|Incidence of AEs leading to discontinuation|Incidence of deaths|Incidence of labornatory abnormalities","Approximately 5 years",null,"Overall response rate (ORR)|Median duration of response (mDOR)|Incidence of anti-drug antibody (ADA) to BMS-986253|Serum biomarker concentration|Maximum observed serum concentration (Cmax)|Time of maximum observed serum concentration (Tmax)|Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]|Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)]|Observed serum concentration at the end of a dosing interval (CTAU)|Trough observed serum concentration at the end of the dosing interval (CTROUGH)","Approximately 5 years",null,"Clinical.Trials@bms.com","Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,","please email:","Bruxelles, Belgium, 1200|Edmonton, Alberta, Canada, T6G 1Z2|Vancouver, British Columbia, Canada, V5Z 4E6|[Active, Not Recruiting]Toronto, Ontario, Canada, M5G 1Z5|Berlin, Germany, 12200|Forli, Italy, 47014|Madrid, Spain, 28034|Lausanne, Switzerland, 1011|Manchester, Greater Manchester, United Kingdom, M20 4Bx|Birmingham, West Midlands, United Kingdom, B15 2Th|Denver, Colorado, United States, 80218|Miami Beach, Florida, United States, 33140|Lutherville, Maryland, United States, 21093|Ann Arbor, Michigan, United States, 48109|Las Vegas, Nevada, United States, 89169|Hackensack, New Jersey, United States, 07601|New York, New York, United States, 10029|Oklahoma City, Oklahoma, United States, 73104|Eugene, Oregon, United States, 97401|Philadelphia, Pennsylvania, United States, 19111|Greenville, South Carolina, United States, 29605|Austin, Texas, United States, 78705|Fairfax, Virginia, United States, 22031","Colorado|Florida|Maryland|Michigan|Nevada|New Jersey|New York|Oklahoma|Oregon|Pennsylvania|South Carolina|Texas|Virginia","Belgium|Canada|Germany|Italy|Spain|Switzerland|United Kingdom|United States","Local Institution|Alberta Local Institution|British Columbia Local Institution|Ontario Local Institution|Hospital Universitario Ramon Y Cajal|Chu Vaudois Lausanne|, Greater Manchester Local Institution|, West Midlands Local Institution|Rocky Mountain Cancer Centers|Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins|University Of Michigan Health System|Comprehensive Cancer Centers Of Nevada|John Theurer Cancer Center At Hackensack University Medical Center|Icahn School Of Medicine At Mount Sinai|Stephenson Cancer Center|Willamette Valley Cancer Institute And Research Center|Greenville Health System|Texas Oncology|Virginia Cancer Specialists, Pc",null,"First line of the email MUST contain NCT # and Site #.",null,"Bristol-Myers Squibb","2020-02-11","2020-05-25T16:37:04.863","2020-05-26T17:10:42.972","NCT03400332"]
["5ecbf431307e3d1b1f8d9d09","NCT03400488","2018-03-20","AstraZeneca","AZN","Recruiting","A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD5718 After Single and Multiple Ascending Dose Administration to Healthy Japanese Men","Azd-5718",null,"Yes","['Azd-5718']","Unknown",null,"Phase 1",2,48,"Anticipated","2018-01-16","2018-06-01","SBP|CBC","Systolic Blood Pressure|Complete Blood Count",{"$nulls":3},"This is a Phase I study to investigate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of the novel compound, AZD5718 in healthy Japanese men. The results from this study will form the basis for decisions on future studies.","This study will be a Phase 1, randomized, single-blind, placebo-controlled, single and multiple ascending dose sequential group design in up to 48 healthy male Japanese subjects, performed at a single study center. The planned number of cohorts is 4 but up to 6 cohorts may be included if the Safety Review Committee (SRC) considers it necessary to repeat a dose level or if additional dose steps are required. Screening will be completed between Days -28 and -1. Primarily gradual escalation of the dose will be conducted with the oral suspension. Eight subjects will participate in each cohort. Four ascending dose levels are planned. Within each cohort 6 subjects will be randomised to receive AZD5718 and 2 subjects randomised to receive placebo. Each subject will receive one dose of AZD5718 or placebo on the first dosing day (Day 1, single ascending dose, SAD) and on Days 3 to 10 (multiple ascending dose, MAD). On Day 2 no dose will be given to the subject. In total each subject will receive 9 doses. Dosing for each ascending dose cohort will proceed after the SRC has evaluated the safety, tolerability and other relevant data of a completed cohort. The subjects will stay at the study site until 48 hours post-dose and will return 7 to 10 days after dosing for a follow-up visit. Each subject will be involved in the study for 7 weeks.","A Phase 1, Randomized, Single-blind, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD5718 After Single and Multiple Ascending Dose Administration to Healthy Japanese Men","D7550C00004","Coronary Artery Disease","Coronary Artery Disease|Coronary Disease","Heart Diseases","Cardiovascular","Experimental|Placebo Comparator","AZD5718|Placebo","Randomized subjects will receive orally once daily dose of AZD5718 oral suspension on Day 1 (SAD) and MAD from Days 3 to 10. On Day 2, no dose will be given. These procedures will be repeated in all cohorts.|Randomized subjects will receive orally once daily dose of placebo matching AZD5718 oral suspension on Day 1 (SAD) and MAD form Days 3 to 10. On Day 2, no dose will be given. These procedures will be repeated in all cohorts.","Drug","AZD5718 oral suspension|Placebo matching AZD5817 oral suspension","In all cohorts, randomized subjects will receive orally AZD5718 oral suspension SAD (60 mg) on Day 1 and MAD (180 mg, 360 mg and 600 mg) from Days 3 to 10. On Day 2, no dose will be given. In total each subject will receive 9 doses of AZD5718.|In all cohorts, randomized subjects will receive orally placebo matching AZD5718 oral suspension on Day 1 and from Days 3 to 10. On Day 2, no dose will be given.",null,"AZD5718|Placebo","\n\n 1. Provision of signed and dated, written informed consent prior to any study specific procedures\n 2. Healthy male Japanese subjects aged 18-50 years with suitable veins for cannulation or repeated venipuncture. A subject will be considered as Japanese if: * both of his parents and all grandparents are Japanese,\n     * he was born in Japan and have a Japanese passport, and\n     * he has not lived outside Japan for more than 10 years.\n    \n    \n 3. Have a body mass index (BMI) between 18 and 30 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg inclusive.\n 4. Provision of signed, written and dated informed consent for optional genetic/biomarker research. If a subject declines to participate in the genetic component of the study, there will be no penalty or loss of benefit to the subject. The subject will not be excluded from other aspects of the study described in this protocol.\n\n","\n\n 1.  History of any clinically important disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.\n 2.  History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs.\n 3.  Any clinically important illness, medical/surgical procedure or trauma within 4 weeks of the first administration of investigational medicinal product (IMP).\n 4.  Any clinically important abnormalities in clinical chemistry, hematology or urinalysis results as judged by the Investigator.\n 5.  Any positive result on Screening for serum hepatitis B surface antigen, hepatitis C antibody and human immunodeficiency virus (HIV).\n 6.  Suspicion or known Gilbert's syndrome.\n 7.  Abnormal vital signs, after 10 minutes supine rest, at screening and check-in, defined as any of the following (repeat evaluations may be done once if the values for a subject are outside the designated range at screening and on Day -1):Systolic blood pressure < 90 mmHg or > 140 mmHg Diastolic blood pressure < 50 mmHg or > 90 mmHg Heart rate < 45 or > 90 beats per minute (bpm)\n     \n     \n 8.  Any clinically important abnormalities in rhythm, conduction or morphology of the resting ECG and any clinically important abnormalities at screening and check-in in the 12-Lead ECG as considered by the Investigator that may interfere with the interpretation of QTc interval changes, including abnormal ST-T-wave morphology, particularly in the protocol defined primary lead or left ventricular hypertrophy. If deemed necessary, an ECG may be repeated once for each ECG measurement.\n 9.  Prolonged QTcF > 450 ms or shortened QTcF < 340 ms or family history of long QT syndrome at screening and check-in. If deemed necessary, an ECG may be repeated once for each ECG measurement.\n 10. PR(PQ) interval shortening < 120 ms (PR > 110 ms but < 120 ms is acceptable if there is no evidence of ventricular pre-excitation) at screening and check-in. If deemed necessary, an ECG may be repeated once for each ECG measurement.\n 11. PR (PQ) interval prolongation (> 240 ms) intermittent second (Wenckebach block while asleep is not exclusive) or third degree atrioventricular (AV) block, or AV dissociation at screening and check-in. If deemed necessary, an ECG may be repeated once for each ECG measurement.\n 12. Persistent or intermittent complete bundle branch block (BBB), incomplete bundle branch block (IBBB), or intraventricular conduction delay (IVCD) with QRS > 110 ms. Subjects with QRS > 110 ms but < 115 ms are acceptable if there is no evidence of e.g., ventricular hypertrophy or pre-excitation, at screening and check-in. If deemed necessary, an ECG may be repeated once for each ECG measurement.\n 13. Known or suspected history of drug abuse as judged by the Investigator.\n 14. Current smokers or those who have smoked or used nicotine products (including e-cigarettes within the previous 3 months).\n 15. History of alcohol abuse or excessive intake of alcohol as judged by the Investigator.\n 16. Positive screen for drugs of abuse or cotinine (nicotine) at screening and check-in (excluding cotinine).\n 17. History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity, as judged by the Investigator or history of hypersensitivity to drugs with a similar chemical structure or class to AZD5718.\n 18. Excessive intake of caffeine-containing drinks or food (e.g., coffee, tea, chocolate,) as judged by the Investigator.\n 19. Use of drugs with enzyme inducing properties such as St John's Wort within 3 weeks prior to the first administration of IMP.\n 20. Use of any prescribed or non-prescribed medication including antacids, analgesics (other than paracetamol/acetaminophen), herbal remedies, megadose vitamins (intake of 20 to 600 times the recommended daily dose) and minerals during the 2 weeks prior to the first administration of investigational product or longer if the medication has a long half-life.\n 21. Plasma donation within 1 month of Screening or any blood donation/blood loss > 500 mL during the 3 months prior to Screening.\n 22. Has received another new chemical entity (defined as a compound which has not been approved for marketing in the US) within 30 days or at least 5 half-lives (whichever is longer) of the first administration of investigational drug in this study. Note: subjects consented and screened, but not randomized in this study or a previous phase I study, are not excluded.\n 23. Subjects who have previously received AZD5718.\n 24. Involvement of any Astra Zeneca, PAREXEL or study site employee or their close relatives.\n 25. Judgment by the Investigator that the subject should not participate in the study if they have any ongoing or recent (i.e., during the Screening period) minor medical complaints that may interfere with the interpretation of study data or are considered unlikely to comply with study procedures, restrictions and requirements.\n 26. Subjects who are vegans or have medical dietary restrictions.\n 27. Subjects who cannot communicate reliably with the study team.\n 28. Vulnerable subjects, e.g., kept in detention, protected adults under guardianship, trusteeship, or committed to an institution by governmental or juridical order.In addition, any of the following is regarded as a criterion for exclusion from the genetic research:\n     \n     \n 29. Previous bone marrow transplant.\n 30. Non-leukocyte depleted whole blood transfusion within 120 days of the date of the genetic sample collection.",{"$nulls":4},"Actual","2018-01-17","Actual","Anticipated","2018-06-01","Anticipated","2018-03-01","2017-12-12","2018-01-10","2018-03-19","No","Coronary Artery Disease,\nCardiovascular disease (CAD),\n5-lipoxygenase activating protein (FLAP) inhibitor,\nLeukotrienes.","Interventional","Treatment","Parallel Assignment","Single (Participant)","Randomized","18 Years","50 Years","Male",null,"Yes",{"$nulls":4},"Yes","No",{"$nulls":19},"Number of patients with Adverse Events (AEs) due to AZD5817|Supine vital sign (Systolic Blood pressure [BP])|Supine vital sign (pulse rate)|Number of participants with abnormal findings in electrocardiograms (ECGs) (safety ECGs, digital ECGs [dECG])|Number of participants with abnormal cardiac telemetry|Number of participants with abnormal findings in physical examinations|Laboratory assessment: Hematology (leukocyte count)|Supine vital sign (diastolic BP)|Laboratory assessment: Clinical chemistry (sodium)|Laboratory assessment: Urinalysis (glucose)|Laboratory assessment: Hematology (Red blood cell [RBC] count)|Laboratory assessment: Hematology (Hemoglobin [Hb])|Laboratory assessment: Hematology (Hematocrit [HCT])|Laboratory assessment: Hematology (Mean corpuscular volume [MCV])|Laboratory assessment: Hematology (Mean corpuscular hemoglobin [MCH])|Laboratory assessment: Hematology (Mean corpuscular hemoglobin concentration [MCHC])|Laboratory assessment: Clinical chemistry (potassium)|Laboratory assessment: Clinical chemistry (urea)|Laboratory assessment: Clinical chemistry (creatinine)|Laboratory assessment: Clinical chemistry (albumin)|Laboratory assessment: Clinical chemistry (calcium)|Laboratory assessment: Clinical chemistry (phosphate)|Laboratory assessment: Clinical chemistry (glucose (fasting))|Laboratory assessment: Clinical chemistry (insulin)|Laboratory assessment: Clinical chemistry (fibrinogen)|Laboratory assessment: Clinical chemistry (thyroid-stimulating hormone)|Laboratory assessment: Urinalysis (blood)|Laboratory assessment: Urinalysis (protein)|Laboratory assessment: Urinalysis (urine creatinine)|Laboratory assessment: Hematology (Differential Count)|Laboratory assessment: Hematology (Platelets)|Laboratory assessment: Hematology (Reticulocytes absolute count)|Laboratory assessment: Clinical chemistry (High sensitivity-C-reactive protein [CRP])|Laboratory assessment: Clinical chemistry (Free T4)|Laboratory assessment: Clinical chemistry (Alkaline phosphatase [ALP])|Laboratory assessment: Clinical chemistry (Alanine aminotransferase [ALT])|Laboratory assessment: Clinical chemistry (Aspartate aminotransferase [AST])|Laboratory assessment: Clinical chemistry (Gamma glutamyl transpeptidase [GGT])|Laboratory assessment: Clinical chemistry (Total Bilirubin)|Laboratory assessment: Clinical chemistry (Unconjugated bilirubin)|Laboratory assessment: Clinical chemistry (Glutamate dehydrogenase)|Laboratory assessment: Clinical chemistry (Lactate dehydrogenase [LDH])","To assess the adverse events as a variable of safety and tolerability of AZD5718 following oral administration of single and multiple ascending doses. Adverse Events will be collected from the start of randomization throughout the treatment period up to and including the follow-up visit. Serious adverse events (SAEs) will be recorded from the time of informed consent.|To assess the vital sign as a variable of safety and tolerability variable of AZD5718 following oral administration of single and multiple ascending doses.|To assess the vital sign as a variable of safety and tolerability of AZD5718 following oral administration of single and multiple ascending doses.|To assess any clinically important abnormalities in the cardiovascular system functioning as a variable of safety and tolerability of AZD5718 following oral administration of single and multiple ascending doses. A 12-lead 10-second safety ECG will be performed with the Schiller Cardiovit CS-200 recorder immediately following all scheduled dECGs. 12-lead continuous dECG will be recorded over at least 5 minutes with the Schiller Cardiovit CS-200 recorder and transmitted to the AstraZeneca central dECG repository, according to AstraZeneca ECG CenterÂ´s standard procedures for settings, recording, and transmission of dECGs. For dECG, QTcF (QT interval corrected for heart rate using Fridericia's formula) will be calculated as QTcF =(QT*(RR/1000)^(-1/3)), where RR (the time between corresponding points on 2 consecutive R waves on ECG) is presented in milliseconds. Heart rate (HR) will also be calculated, based on the RR interval.|To assess any clinically important abnormalities in the cardiovascular system functioning (heart beat/rythm) using 2-lead real-time telemetry ECG as a variable of safety and tolerability of AZD5718 following oral administration of single and multiple ascending doses. The telemetry monitoring system will be reviewed by the Investigator or research nurse and paper printouts of any clinically important events will be stored as source data.|To assess any clinically important abnormal findings in physical conditions as a variable of safety and tolerability of AZD5718 following oral administration of single and multiple ascending doses. The complete physical examinations include an assessment of the general appearance, skin, cardiovascular, respiratory, abdomen, head, and neck (including ears, eyes, nose, and throat), lymph nodes, thyroid, musculoskeletal and neurological systems. The brief physical examinations include an assessment of the general appearance, skin, cardiovascular system, respiratory and abdomen. Any new or aggravated clinically relevant abnormal medical finding at a physical examination as compared with the baseline assessment will be reported as an adverse event.|To assess the leukocyte count as a variable of safety and tolerability of AZD5718 following oral administration of single and multiple ascending doses.|To assess the clinical chemistry value (sodium) as a variable of safety and tolerability of AZD5718, following oral administration of single and multiple ascending doses.|To assess urinalysis (glucose) as a variable of safety and tolerability of AZD5718, following oral administration of single and multiple ascending doses.|To assess the RBC count as a variable of safety and tolerability of AZD5718 following oral administration of single and multiple ascending doses.|To assess the Hb as a criterion of safety and tolerability variable of AZD5718 following oral administration of single and multiple ascending doses.|To assess the HCT as a variable of safety and tolerability of AZD5718 following oral administration of single and multiple ascending doses.|To assess the MCV as a variable of safety and tolerability of AZD5718 following oral administration of single and multiple ascending doses.|To assess the MCH as a variable of safety and tolerability of AZD5718 following oral administration of single and multiple ascending doses.|To assess the MCHC as a variable of safety and tolerability variable of AZD5718 following oral administration of single and multiple ascending doses.|To assess the clinical chemistry value (potassium) as a variable of safety and tolerability of AZD5718, following oral administration of single and multiple ascending doses.|To assess the clinical chemistry value (urea) as a variable of safety and tolerability of AZD5718, following oral administration of single and multiple ascending doses.|To assess the clinical chemistry value (creatinine) as a variable of safety and tolerability of AZD5718, following oral administration of single and multiple ascending doses.|To assess the clinical chemistry value (albumin) as a variable of safety and tolerability of AZD5718, following oral administration of single and multiple ascending doses.|To assess the clinical chemistry value (calcium) as a variable of safety and tolerability of AZD5718, following oral administration of single and multiple ascending doses.|To assess the clinical chemistry value (phosphate) as a variable of safety and tolerability of AZD5718, following oral administration of single and multiple ascending doses.|To assess the clinical chemistry value (glucose (fasting)) as a variable of safety and tolerability of AZD5718, following oral administration of single and multiple ascending doses.|To assess the clinical chemistry value (insulin) as a variable of safety and tolerability of AZD5718, following oral administration of single and multiple ascending doses.|To assess the clinical chemistry value (fibrinogen) as a variable of safety and tolerability of AZD5718, following oral administration of single and multiple ascending doses.|To assess the clinical chemistry value (thyroid-stimulating hormone) as a variable of safety and tolerability of AZD5718, following oral administration of single and multiple ascending doses.|To assess urinalysis (blood) as a variable of safety and tolerability of AZD5718, following oral administration of single and multiple ascending doses. If urinalysis is positive for blood, a microscopy test will be performed to assess RBC, white blood cell|To assess urinalysis (protein) as a variable of safety and tolerability of AZD5718, following oral administration of single and multiple ascending doses. If urinalysis is positive for protein, a microscopy test will be performed to assess RBC, WBC, casts|To assess urinalysis (urine creatinine) as a variable of safety and tolerability of AZD5718, following oral administration of single and multiple ascending doses.|To assess the differential count as a variable of safety and tolerability of AZD5718 following oral administration of single and multiple ascending doses.|To assess the platelets as a variable of safety and tolerability of AZD5718 following oral administration of single and multiple ascending doses.|To assess the reticulocytes absolute count as a variable of safety and tolerability of AZD5718 following oral administration of single and multiple ascending doses.|To assess the clinical chemistry value (CRP) as a variable of safety and tolerability of AZD5718, following oral administration of single and multiple ascending doses.|To assess the clinical chemistry value (Free T4) as a variable of safety and tolerability of AZD5718, following oral administration of single and multiple ascending doses.|To assess the clinical chemistry value (ALP) as a variable of safety and tolerability of AZD5718, following oral administration of single and multiple ascending doses.|To assess the clinical chemistry value (ALT) as a variable of safety and tolerability of AZD5718, following oral administration of single and multiple ascending doses.|To assess the clinical chemistry value (AST) as a variable of safety and tolerability of AZD5718, following oral administration of single and multiple ascending doses.|To assess the clinical chemistry value (GGT) as a variable of safety and tolerability of AZD5718, following oral administration of single and multiple ascending doses.|To assess the clinical chemistry value (total bilirubin) as a variable of safety and tolerability of AZD5718, following oral administration of single and multiple ascending doses.|To assess the clinical chemistry value (unconjugated bilirubin) as a variable of safety and tolerability of AZD5718, following oral administration of single and multiple ascending doses.|To assess the clinical chemistry value (glutamate dehydrogenase) as a variable of safety and tolerability of AZD5718, following oral administration of single and multiple ascending doses.|To assess the clinical chemistry value (LDH) as a variable of safety and tolerability of AZD5718, following oral administration of single and multiple ascending doses.","Change from baseline up to follow-up (7 to 10 days post-(final) dose)|From baseline up to follow-up (7 to 10 days post-(final) dose). For dECG: Days 1 to 12|From baseline up to Day 10|From baseline up to follow-up (7 to 10 days post-(final) dose)|WBC, casts|cellular, granular, hyaline).","Plasma PK assessment: Observed maximum plasma concentration (Cmax) assessment for AZD5817 after single and repeated oral dosing|Plasma PK assessment: Time to reach peak or maximum observed concentration following drug administration (tmax) assessment for AZD5817 after single and repeated oral dosing|Plasma PK assessment: Terminal rate constant (Î»Z) assessment for AZD5817 after single and repeated oral dosing|Plasma PK assessment: Terminal half-life (tÂ½Î»z) assessment for AZD5817 after single and repeated oral dosing|Plasma PK assessment: Area under the plasma concentration-time curve from time zero to 24 hours after dosing (AUC(0-24)) assessment for AZD5817 after single and repeated oral dosing|Plasma PK assessment: Area under the plasma concentration-curve from time zero to the time of last quantifiable analyte concentration (AUC(0-last)) assessment for AZD5817 after single and repeated oral dosing|Plasma PK assessment: Area under the plasma concentration-curve over the dosing interval (AUC(0-Ï„)) assessment for AZD5817 after single and repeated oral dosing|Plasma PK assessment: Area under the concentration-time curve from time zero extrapolated to infinity (AUC) assessment for AZD5817 after single and repeated oral dosing|Plasma PK assessment: Apparent total body clearance of drug from plasma after extravascular administration (CL/F) assessment for AZD5817 after single and repeated oral dosing|Plasma PK assessment: Mean Residence Time (MRT) assessment for AZD5817 after single and repeated oral dosing|Plasma PK assessment: Apparent volume of distribution for parent drug at terminal phase (extravascular administration), (Vz/F) assessment for AZD5817 after single and repeated oral dosing|Plasma PK assessment: Observed minimum concentration, (Cmin) assessment for AZD5817 after single and repeated oral dosing (Day 10)|Plasma PK assessment: Observed average concentration (Cavg) assessment for AZD5817 after single and repeated oral dosing (Day 10)|Plasma PK assessment: Accumulation ratio (Rac Cmax) assessment for AZD5817 after single and repeated oral dosing|Plasma PK assessment: Accumulation ratio (Rac AUC) assessment for AZD5817 after single and repeated oral dosing|Plasma PK assessment: Temporal change parameter in systemic exposure (TCP) assessment for AZD5817 after single and repeated oral dosing|Urine PK assessment: Cumulative amount of unchanged drug excreted in urine from time zero to the last sampling interval (Ae(0-last)) assessment for AZD5817 after single and repeated oral dosing|Urine PK assessment: Fraction of dose excreted unchanged into the urine from time zero to the last sampling interval measured time point for an analyte (Fe(0-last)) assessment for AZD5817 after single and repeated oral dosing|Urine PK assessment: Renal clearance of drug from plasma (CLR) assessment for AZD5817 after single and repeated oral dosing|PD parameter: urine Leukotriene E4 (LTE4) assessment for AZD5817 after single and repeated oral dosing","To assess Cmax of AZD5718 after single and repeated oral dosing.|To assess tmax of AZD5718 after single and repeated oral dosing.|To assess Î»Z of AZD5718 after single and repeated oral dosing. Î»Z will be estimated by log-linear least-squares regression of the terminal part of the concentration-time curve.|To assess tÂ½Î»z of AZD5718 after single and repeated oral dosing. tÂ½Î»z will be estimated as (ln2)/Î»Z.|To assess AUC(0-24) of AZD5718 after single and repeated oral dosing.|To assess AUC(0-last) of AZD5718 after single and repeated oral dosing.|To assess AUC(0-Ï„) of AZD5718 after single and repeated oral dosing.|To assess AUC of AZD5718 after single and repeated oral dosing. AUC is estimated by AUC(0-last) + Clast/Î»Z where Clast is the last observed quantifiable concentration.|To assess CL/F of AZD5718 after single and repeated oral dosing.|To assess MRT of AZD5718 after single and repeated oral dosing.|To assess Vz/F of AZD5718 after single and repeated oral dosing. Vz/F will be estimated by dividing the apparent clearance (CL/F) by Î»Z.|To assess Cmin of AZD5718 after single and repeated oral dosing. Cmin will be taken directly from the individual concentration-time curve.|To assess Cavg of AZD5718 after single and repeated oral dosing. Cavg will be taken directly from the individual concentration-time curve.|To assess Rac Cmax of AZD5718 after single and repeated oral dosing. Rac Cmax will be calculated as Cmax Day 10/ Cmax Day 1.|To assess Rac AUC of AZD5718 after single and repeated oral dosing. Rac AUC will be calculated as AUCÏ„ Day 10/ AUCÏ„ Day 1.|To assess TCP of AZD5718 after single and repeated oral dosing. TCP will be calculated as AUCÏ„Day 10/AUCDay 1.|To assess Ae(0-last) of AZD5718 after single and repeated oral dosing.|To assess Fe(0-last) of AZD5718 after single and repeated oral dosing. Fe(0-last) will be estimated by dividing Ae(0-last) by dose.|To assess CLR of AZD5718 after single and repeated oral dosing. CLR will be estimated by dividing Ae(0-last) by AUC(0-t)).|To evaluate the PD of AZD5718, by assessment of urine LTE4 (u-LTE4), after single and repeated oral dosing.","Day 1 and Day 10: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 32 and 48 hours (Day 3 pre-dose) post-dose, Day 4-9 pre morning dose|Day 1 and Day 10: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 32 and 48 hours (Day 3 pre-dose) post-dose|Day 10: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 32 and 48 hours (Day 3 pre-dose) post-dose|Day 10 pooled 0-3, 3-6, 6-9, 9-12 hours and 12-24 hours urine|Day -1 (spot sample), Day 1 and Day 10 spot sample pre-dose and pooled 0-3, 3-6, 6-9 and 9-12 hours urine, spot sample at 24, 36 hours post-dose, Day 3-9: spot sample pre-dose","information.center@astrazeneca.com","AstraZeneca Clinical Study Information Center","1-877-240-9479","Glendale, California, United States, 91206","California","United States","Research Site",{"$nulls":4},"2018-03-19","2020-05-25T16:37:05.106","2020-05-26T17:10:42.972","NCT03400488"]
["5ecbf431feab101b155308aa","NCT03400488","2018-05-22","AstraZeneca","AZN","Recruiting","A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD5718 After Single and Multiple Ascending Dose Administration to Healthy Japanese Men","Azd-5718",null,"Yes","['Azd-5718']","Unknown",null,"Phase 1",2,48,"Anticipated","2018-01-16","2018-06-01","SBP|CBC","Systolic Blood Pressure|Complete Blood Count",{"$nulls":3},"This is a Phase I study to investigate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of the novel compound, AZD5718 in healthy Japanese men. The results from this study will form the basis for decisions on future studies.","This study will be a Phase 1, randomized, single-blind, placebo-controlled, single and multiple ascending dose sequential group design in up to 48 healthy male Japanese subjects, performed at a single study center. The planned number of cohorts is 4 but up to 6 cohorts may be included if the Safety Review Committee (SRC) considers it necessary to repeat a dose level or if additional dose steps are required. Screening will be completed between Days -28 and -1. Primarily gradual escalation of the dose will be conducted with the oral suspension. Eight subjects will participate in each cohort. Four ascending dose levels are planned. Within each cohort 6 subjects will be randomised to receive AZD5718 and 2 subjects randomised to receive placebo. Each subject will receive one dose of AZD5718 or placebo on the first dosing day (Day 1, single ascending dose, SAD) and on Days 3 to 10 (multiple ascending dose, MAD). On Day 2 no dose will be given to the subject. In total each subject will receive 9 doses. Dosing for each ascending dose cohort will proceed after the SRC has evaluated the safety, tolerability and other relevant data of a completed cohort. The subjects will stay at the study site until 48 hours post-dose and will return 7 to 10 days after dosing for a follow-up visit. Each subject will be involved in the study for 7 weeks.","A Phase 1, Randomized, Single-blind, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD5718 After Single and Multiple Ascending Dose Administration to Healthy Japanese Men","D7550C00004","Coronary Artery Disease","Coronary Artery Disease|Coronary Disease","Heart Diseases","Cardiovascular","Experimental|Placebo Comparator","AZD5718|Placebo","Randomized subjects will receive orally once daily dose of AZD5718 oral suspension on Day 1 (SAD) and MAD from Days 3 to 10. On Day 2, no dose will be given. These procedures will be repeated in all cohorts.|Randomized subjects will receive orally once daily dose of placebo matching AZD5718 oral suspension on Day 1 (SAD) and MAD form Days 3 to 10. On Day 2, no dose will be given. These procedures will be repeated in all cohorts.","Drug","AZD5718 oral suspension|Placebo matching AZD5817 oral suspension","In all cohorts, randomized subjects will receive orally AZD5718 oral suspension SAD (60 mg) on Day 1 and MAD (180 mg, 360 mg and 600 mg) from Days 3 to 10. On Day 2, no dose will be given. In total each subject will receive 9 doses of AZD5718.|In all cohorts, randomized subjects will receive orally placebo matching AZD5718 oral suspension on Day 1 and from Days 3 to 10. On Day 2, no dose will be given.",null,"AZD5718|Placebo","\n\n 1. Provision of signed and dated, written informed consent prior to any study specific procedures\n 2. Healthy male Japanese subjects aged 18-50 years with suitable veins for cannulation or repeated venipuncture. A subject will be considered as Japanese if: * both of his parents and all grandparents are Japanese,\n     * he was born in Japan and have a Japanese passport, and\n     * he has not lived outside Japan for more than 10 years.\n    \n    \n 3. Have a body mass index (BMI) between 18 and 30 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg inclusive.\n 4. Provision of signed, written and dated informed consent for optional genetic/biomarker research. If a subject declines to participate in the genetic component of the study, there will be no penalty or loss of benefit to the subject. The subject will not be excluded from other aspects of the study described in this protocol.\n\n","\n\n 1.  History of any clinically important disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.\n 2.  History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs.\n 3.  Any clinically important illness, medical/surgical procedure or trauma within 4 weeks of the first administration of investigational medicinal product (IMP).\n 4.  Any clinically important abnormalities in clinical chemistry, hematology or urinalysis results as judged by the Investigator.\n 5.  Any positive result on Screening for serum hepatitis B surface antigen, hepatitis C antibody and human immunodeficiency virus (HIV).\n 6.  Suspicion or known Gilbert's syndrome.\n 7.  Abnormal vital signs, after 10 minutes supine rest, at screening and check-in, defined as any of the following (repeat evaluations may be done once if the values for a subject are outside the designated range at screening and on Day -1):Systolic blood pressure < 90 mmHg or > 140 mmHg Diastolic blood pressure < 50 mmHg or > 90 mmHg Heart rate < 45 or > 90 beats per minute (bpm)\n     \n     \n 8.  Any clinically important abnormalities in rhythm, conduction or morphology of the resting ECG and any clinically important abnormalities at screening and check-in in the 12-Lead ECG as considered by the Investigator that may interfere with the interpretation of QTc interval changes, including abnormal ST-T-wave morphology, particularly in the protocol defined primary lead or left ventricular hypertrophy. If deemed necessary, an ECG may be repeated once for each ECG measurement.\n 9.  Prolonged QTcF > 450 ms or shortened QTcF < 340 ms or family history of long QT syndrome at screening and check-in. If deemed necessary, an ECG may be repeated once for each ECG measurement.\n 10. PR(PQ) interval shortening < 120 ms (PR > 110 ms but < 120 ms is acceptable if there is no evidence of ventricular pre-excitation) at screening and check-in. If deemed necessary, an ECG may be repeated once for each ECG measurement.\n 11. PR (PQ) interval prolongation (> 240 ms) intermittent second (Wenckebach block while asleep is not exclusive) or third degree atrioventricular (AV) block, or AV dissociation at screening and check-in. If deemed necessary, an ECG may be repeated once for each ECG measurement.\n 12. Persistent or intermittent complete bundle branch block (BBB), incomplete bundle branch block (IBBB), or intraventricular conduction delay (IVCD) with QRS > 110 ms. Subjects with QRS > 110 ms but < 115 ms are acceptable if there is no evidence of e.g., ventricular hypertrophy or pre-excitation, at screening and check-in. If deemed necessary, an ECG may be repeated once for each ECG measurement.\n 13. Known or suspected history of drug abuse as judged by the Investigator.\n 14. Current smokers or those who have smoked or used nicotine products (including e-cigarettes within the previous 3 months).\n 15. History of alcohol abuse or excessive intake of alcohol as judged by the Investigator.\n 16. Positive screen for drugs of abuse or cotinine (nicotine) at screening and check-in (excluding cotinine).\n 17. History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity, as judged by the Investigator or history of hypersensitivity to drugs with a similar chemical structure or class to AZD5718.\n 18. Excessive intake of caffeine-containing drinks or food (e.g., coffee, tea, chocolate,) as judged by the Investigator.\n 19. Use of drugs with enzyme inducing properties such as St John's Wort within 3 weeks prior to the first administration of IMP.\n 20. Use of any prescribed or non-prescribed medication including antacids, analgesics (other than paracetamol/acetaminophen), herbal remedies, megadose vitamins (intake of 20 to 600 times the recommended daily dose) and minerals during the 2 weeks prior to the first administration of investigational product or longer if the medication has a long half-life.\n 21. Plasma donation within 1 month of Screening or any blood donation/blood loss > 500 mL during the 3 months prior to Screening.\n 22. Has received another new chemical entity (defined as a compound which has not been approved for marketing in the US) within 30 days or at least 5 half-lives (whichever is longer) of the first administration of investigational drug in this study. Note: subjects consented and screened, but not randomized in this study or a previous phase I study, are not excluded.\n 23. Subjects who have previously received AZD5718.\n 24. Involvement of any Astra Zeneca, PAREXEL or study site employee or their close relatives.\n 25. Judgment by the Investigator that the subject should not participate in the study if they have any ongoing or recent (i.e., during the Screening period) minor medical complaints that may interfere with the interpretation of study data or are considered unlikely to comply with study procedures, restrictions and requirements.\n 26. Subjects who are vegans or have medical dietary restrictions.\n 27. Subjects who cannot communicate reliably with the study team.\n 28. Vulnerable subjects, e.g., kept in detention, protected adults under guardianship, trusteeship, or committed to an institution by governmental or juridical order.In addition, any of the following is regarded as a criterion for exclusion from the genetic research:\n     \n     \n 29. Previous bone marrow transplant.\n 30. Non-leukocyte depleted whole blood transfusion within 120 days of the date of the genetic sample collection.",{"$nulls":4},"Actual","2018-01-17","Actual","Anticipated","2018-06-01","Anticipated","2018-05-01","2017-12-12","2018-01-10","2018-05-21","No","Coronary Artery Disease,\nCardiovascular disease (CAD),\n5-lipoxygenase activating protein (FLAP) inhibitor,\nLeukotrienes.","Interventional","Treatment","Parallel Assignment","Single (Participant)","Randomized","18 Years","50 Years","Male",null,"Yes",{"$nulls":4},"Yes","No",{"$nulls":19},"Number of patients with Adverse Events (AEs) due to AZD5817|Supine vital sign (Systolic Blood pressure [BP])|Supine vital sign (pulse rate)|Number of participants with abnormal findings in electrocardiograms (ECGs) (safety ECGs, digital ECGs [dECG])|Number of participants with abnormal cardiac telemetry|Number of participants with abnormal findings in physical examinations|Laboratory assessment: Hematology (leukocyte count)|Supine vital sign (diastolic BP)|Laboratory assessment: Clinical chemistry (sodium)|Laboratory assessment: Urinalysis (glucose)|Laboratory assessment: Hematology (Red blood cell [RBC] count)|Laboratory assessment: Hematology (Hemoglobin [Hb])|Laboratory assessment: Hematology (Hematocrit [HCT])|Laboratory assessment: Hematology (Mean corpuscular volume [MCV])|Laboratory assessment: Hematology (Mean corpuscular hemoglobin [MCH])|Laboratory assessment: Hematology (Mean corpuscular hemoglobin concentration [MCHC])|Laboratory assessment: Clinical chemistry (potassium)|Laboratory assessment: Clinical chemistry (urea)|Laboratory assessment: Clinical chemistry (creatinine)|Laboratory assessment: Clinical chemistry (albumin)|Laboratory assessment: Clinical chemistry (calcium)|Laboratory assessment: Clinical chemistry (phosphate)|Laboratory assessment: Clinical chemistry (glucose (fasting))|Laboratory assessment: Clinical chemistry (insulin)|Laboratory assessment: Clinical chemistry (fibrinogen)|Laboratory assessment: Clinical chemistry (thyroid-stimulating hormone)|Laboratory assessment: Urinalysis (blood)|Laboratory assessment: Urinalysis (protein)|Laboratory assessment: Urinalysis (urine creatinine)|Laboratory assessment: Hematology (Differential Count)|Laboratory assessment: Hematology (Platelets)|Laboratory assessment: Hematology (Reticulocytes absolute count)|Laboratory assessment: Clinical chemistry (High sensitivity-C-reactive protein [CRP])|Laboratory assessment: Clinical chemistry (Free T4)|Laboratory assessment: Clinical chemistry (Alkaline phosphatase [ALP])|Laboratory assessment: Clinical chemistry (Alanine aminotransferase [ALT])|Laboratory assessment: Clinical chemistry (Aspartate aminotransferase [AST])|Laboratory assessment: Clinical chemistry (Gamma glutamyl transpeptidase [GGT])|Laboratory assessment: Clinical chemistry (Total Bilirubin)|Laboratory assessment: Clinical chemistry (Unconjugated bilirubin)|Laboratory assessment: Clinical chemistry (Glutamate dehydrogenase)|Laboratory assessment: Clinical chemistry (Lactate dehydrogenase [LDH])","To assess the adverse events as a variable of safety and tolerability of AZD5718 following oral administration of single and multiple ascending doses. Adverse Events will be collected from the start of randomization throughout the treatment period up to and including the follow-up visit. Serious adverse events (SAEs) will be recorded from the time of informed consent.|To assess the vital sign as a variable of safety and tolerability variable of AZD5718 following oral administration of single and multiple ascending doses.|To assess the vital sign as a variable of safety and tolerability of AZD5718 following oral administration of single and multiple ascending doses.|To assess any clinically important abnormalities in the cardiovascular system functioning as a variable of safety and tolerability of AZD5718 following oral administration of single and multiple ascending doses. A 12-lead 10-second safety ECG will be performed with the Schiller Cardiovit CS-200 recorder immediately following all scheduled dECGs. 12-lead continuous dECG will be recorded over at least 5 minutes with the Schiller Cardiovit CS-200 recorder and transmitted to the AstraZeneca central dECG repository, according to AstraZeneca ECG CenterÂ´s standard procedures for settings, recording, and transmission of dECGs. For dECG, QTcF (QT interval corrected for heart rate using Fridericia's formula) will be calculated as QTcF =(QT*(RR/1000)^(-1/3)), where RR (the time between corresponding points on 2 consecutive R waves on ECG) is presented in milliseconds. Heart rate (HR) will also be calculated, based on the RR interval.|To assess any clinically important abnormalities in the cardiovascular system functioning (heart beat/rythm) using 2-lead real-time telemetry ECG as a variable of safety and tolerability of AZD5718 following oral administration of single and multiple ascending doses. The telemetry monitoring system will be reviewed by the Investigator or research nurse and paper printouts of any clinically important events will be stored as source data.|To assess any clinically important abnormal findings in physical conditions as a variable of safety and tolerability of AZD5718 following oral administration of single and multiple ascending doses. The complete physical examinations include an assessment of the general appearance, skin, cardiovascular, respiratory, abdomen, head, and neck (including ears, eyes, nose, and throat), lymph nodes, thyroid, musculoskeletal and neurological systems. The brief physical examinations include an assessment of the general appearance, skin, cardiovascular system, respiratory and abdomen. Any new or aggravated clinically relevant abnormal medical finding at a physical examination as compared with the baseline assessment will be reported as an adverse event.|To assess the leukocyte count as a variable of safety and tolerability of AZD5718 following oral administration of single and multiple ascending doses.|To assess the clinical chemistry value (sodium) as a variable of safety and tolerability of AZD5718, following oral administration of single and multiple ascending doses.|To assess urinalysis (glucose) as a variable of safety and tolerability of AZD5718, following oral administration of single and multiple ascending doses.|To assess the RBC count as a variable of safety and tolerability of AZD5718 following oral administration of single and multiple ascending doses.|To assess the Hb as a criterion of safety and tolerability variable of AZD5718 following oral administration of single and multiple ascending doses.|To assess the HCT as a variable of safety and tolerability of AZD5718 following oral administration of single and multiple ascending doses.|To assess the MCV as a variable of safety and tolerability of AZD5718 following oral administration of single and multiple ascending doses.|To assess the MCH as a variable of safety and tolerability of AZD5718 following oral administration of single and multiple ascending doses.|To assess the MCHC as a variable of safety and tolerability variable of AZD5718 following oral administration of single and multiple ascending doses.|To assess the clinical chemistry value (potassium) as a variable of safety and tolerability of AZD5718, following oral administration of single and multiple ascending doses.|To assess the clinical chemistry value (urea) as a variable of safety and tolerability of AZD5718, following oral administration of single and multiple ascending doses.|To assess the clinical chemistry value (creatinine) as a variable of safety and tolerability of AZD5718, following oral administration of single and multiple ascending doses.|To assess the clinical chemistry value (albumin) as a variable of safety and tolerability of AZD5718, following oral administration of single and multiple ascending doses.|To assess the clinical chemistry value (calcium) as a variable of safety and tolerability of AZD5718, following oral administration of single and multiple ascending doses.|To assess the clinical chemistry value (phosphate) as a variable of safety and tolerability of AZD5718, following oral administration of single and multiple ascending doses.|To assess the clinical chemistry value (glucose (fasting)) as a variable of safety and tolerability of AZD5718, following oral administration of single and multiple ascending doses.|To assess the clinical chemistry value (insulin) as a variable of safety and tolerability of AZD5718, following oral administration of single and multiple ascending doses.|To assess the clinical chemistry value (fibrinogen) as a variable of safety and tolerability of AZD5718, following oral administration of single and multiple ascending doses.|To assess the clinical chemistry value (thyroid-stimulating hormone) as a variable of safety and tolerability of AZD5718, following oral administration of single and multiple ascending doses.|To assess urinalysis (blood) as a variable of safety and tolerability of AZD5718, following oral administration of single and multiple ascending doses. If urinalysis is positive for blood, a microscopy test will be performed to assess RBC, white blood cell|To assess urinalysis (protein) as a variable of safety and tolerability of AZD5718, following oral administration of single and multiple ascending doses. If urinalysis is positive for protein, a microscopy test will be performed to assess RBC, WBC, casts|To assess urinalysis (urine creatinine) as a variable of safety and tolerability of AZD5718, following oral administration of single and multiple ascending doses.|To assess the differential count as a variable of safety and tolerability of AZD5718 following oral administration of single and multiple ascending doses.|To assess the platelets as a variable of safety and tolerability of AZD5718 following oral administration of single and multiple ascending doses.|To assess the reticulocytes absolute count as a variable of safety and tolerability of AZD5718 following oral administration of single and multiple ascending doses.|To assess the clinical chemistry value (CRP) as a variable of safety and tolerability of AZD5718, following oral administration of single and multiple ascending doses.|To assess the clinical chemistry value (Free T4) as a variable of safety and tolerability of AZD5718, following oral administration of single and multiple ascending doses.|To assess the clinical chemistry value (ALP) as a variable of safety and tolerability of AZD5718, following oral administration of single and multiple ascending doses.|To assess the clinical chemistry value (ALT) as a variable of safety and tolerability of AZD5718, following oral administration of single and multiple ascending doses.|To assess the clinical chemistry value (AST) as a variable of safety and tolerability of AZD5718, following oral administration of single and multiple ascending doses.|To assess the clinical chemistry value (GGT) as a variable of safety and tolerability of AZD5718, following oral administration of single and multiple ascending doses.|To assess the clinical chemistry value (total bilirubin) as a variable of safety and tolerability of AZD5718, following oral administration of single and multiple ascending doses.|To assess the clinical chemistry value (unconjugated bilirubin) as a variable of safety and tolerability of AZD5718, following oral administration of single and multiple ascending doses.|To assess the clinical chemistry value (glutamate dehydrogenase) as a variable of safety and tolerability of AZD5718, following oral administration of single and multiple ascending doses.|To assess the clinical chemistry value (LDH) as a variable of safety and tolerability of AZD5718, following oral administration of single and multiple ascending doses.","Change from baseline up to follow-up (7 to 10 days post-(final) dose)|From baseline up to follow-up (7 to 10 days post-(final) dose). For dECG: Days 1 to 12|From baseline up to Day 10|From baseline up to follow-up (7 to 10 days post-(final) dose)|WBC, casts|cellular, granular, hyaline).","Plasma PK assessment: Observed maximum plasma concentration (Cmax) assessment for AZD5817 after single and repeated oral dosing|Plasma PK assessment: Time to reach peak or maximum observed concentration following drug administration (tmax) assessment for AZD5817 after single and repeated oral dosing|Plasma PK assessment: Terminal rate constant (Î»Z) assessment for AZD5817 after single and repeated oral dosing|Plasma PK assessment: Terminal half-life (tÂ½Î»z) assessment for AZD5817 after single and repeated oral dosing|Plasma PK assessment: Area under the plasma concentration-time curve from time zero to 24 hours after dosing (AUC(0-24)) assessment for AZD5817 after single and repeated oral dosing|Plasma PK assessment: Area under the plasma concentration-curve from time zero to the time of last quantifiable analyte concentration (AUC(0-last)) assessment for AZD5817 after single and repeated oral dosing|Plasma PK assessment: Area under the plasma concentration-curve over the dosing interval (AUC(0-Ï„)) assessment for AZD5817 after single and repeated oral dosing|Plasma PK assessment: Area under the concentration-time curve from time zero extrapolated to infinity (AUC) assessment for AZD5817 after single and repeated oral dosing|Plasma PK assessment: Apparent total body clearance of drug from plasma after extravascular administration (CL/F) assessment for AZD5817 after single and repeated oral dosing|Plasma PK assessment: Mean Residence Time (MRT) assessment for AZD5817 after single and repeated oral dosing|Plasma PK assessment: Apparent volume of distribution for parent drug at terminal phase (extravascular administration), (Vz/F) assessment for AZD5817 after single and repeated oral dosing|Plasma PK assessment: Observed minimum concentration, (Cmin) assessment for AZD5817 after single and repeated oral dosing (Day 10)|Plasma PK assessment: Observed average concentration (Cavg) assessment for AZD5817 after single and repeated oral dosing (Day 10)|Plasma PK assessment: Accumulation ratio (Rac Cmax) assessment for AZD5817 after single and repeated oral dosing|Plasma PK assessment: Accumulation ratio (Rac AUC) assessment for AZD5817 after single and repeated oral dosing|Plasma PK assessment: Temporal change parameter in systemic exposure (TCP) assessment for AZD5817 after single and repeated oral dosing|Urine PK assessment: Cumulative amount of unchanged drug excreted in urine from time zero to the last sampling interval (Ae(0-last)) assessment for AZD5817 after single and repeated oral dosing|Urine PK assessment: Fraction of dose excreted unchanged into the urine from time zero to the last sampling interval measured time point for an analyte (Fe(0-last)) assessment for AZD5817 after single and repeated oral dosing|Urine PK assessment: Renal clearance of drug from plasma (CLR) assessment for AZD5817 after single and repeated oral dosing|PD parameter: urine Leukotriene E4 (LTE4) assessment for AZD5817 after single and repeated oral dosing","To assess Cmax of AZD5718 after single and repeated oral dosing.|To assess tmax of AZD5718 after single and repeated oral dosing.|To assess Î»Z of AZD5718 after single and repeated oral dosing. Î»Z will be estimated by log-linear least-squares regression of the terminal part of the concentration-time curve.|To assess tÂ½Î»z of AZD5718 after single and repeated oral dosing. tÂ½Î»z will be estimated as (ln2)/Î»Z.|To assess AUC(0-24) of AZD5718 after single and repeated oral dosing.|To assess AUC(0-last) of AZD5718 after single and repeated oral dosing.|To assess AUC(0-Ï„) of AZD5718 after single and repeated oral dosing.|To assess AUC of AZD5718 after single and repeated oral dosing. AUC is estimated by AUC(0-last) + Clast/Î»Z where Clast is the last observed quantifiable concentration.|To assess CL/F of AZD5718 after single and repeated oral dosing.|To assess MRT of AZD5718 after single and repeated oral dosing.|To assess Vz/F of AZD5718 after single and repeated oral dosing. Vz/F will be estimated by dividing the apparent clearance (CL/F) by Î»Z.|To assess Cmin of AZD5718 after single and repeated oral dosing. Cmin will be taken directly from the individual concentration-time curve.|To assess Cavg of AZD5718 after single and repeated oral dosing. Cavg will be taken directly from the individual concentration-time curve.|To assess Rac Cmax of AZD5718 after single and repeated oral dosing. Rac Cmax will be calculated as Cmax Day 10/ Cmax Day 1.|To assess Rac AUC of AZD5718 after single and repeated oral dosing. Rac AUC will be calculated as AUCÏ„ Day 10/ AUCÏ„ Day 1.|To assess TCP of AZD5718 after single and repeated oral dosing. TCP will be calculated as AUCÏ„Day 10/AUCDay 1.|To assess Ae(0-last) of AZD5718 after single and repeated oral dosing.|To assess Fe(0-last) of AZD5718 after single and repeated oral dosing. Fe(0-last) will be estimated by dividing Ae(0-last) by dose.|To assess CLR of AZD5718 after single and repeated oral dosing. CLR will be estimated by dividing Ae(0-last) by AUC(0-t)).|To evaluate the PD of AZD5718, by assessment of urine LTE4 (u-LTE4), after single and repeated oral dosing.","Day 1 and Day 10: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 32 and 48 hours (Day 3 pre-dose) post-dose, Day 4-9 pre morning dose|Day 1 and Day 10: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 32 and 48 hours (Day 3 pre-dose) post-dose|Day 10: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 32 and 48 hours (Day 3 pre-dose) post-dose|Day 10 pooled 0-3, 3-6, 6-9, 9-12 hours and 12-24 hours urine|Day -1 (spot sample), Day 1 and Day 10 spot sample pre-dose and pooled 0-3, 3-6, 6-9 and 9-12 hours urine, spot sample at 24, 36 hours post-dose, Day 3-9: spot sample pre-dose","information.center@astrazeneca.com","AstraZeneca Clinical Study Information Center","1-877-240-9479","Glendale, California, United States, 91206","California","United States","Research Site",{"$nulls":4},"2018-05-21","2020-05-25T16:37:05.706","2020-05-26T17:10:42.972","NCT03400488"]
["5ecbf43111702c1b1b916a89","NCT03400488","2018-06-15","AstraZeneca","AZN","Completed","A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD5718 After Single and Multiple Ascending Dose Administration to Healthy Japanese Men","Azd-5718",null,"Yes","['Azd-5718']","Unknown",null,"Phase 1",2,32,"Actual","2018-01-16","2018-06-12","SBP|CBC","Systolic Blood Pressure|Complete Blood Count",{"$nulls":3},"This is a Phase I study to investigate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of the novel compound, AZD5718 in healthy Japanese men. The results from this study will form the basis for decisions on future studies.","This study will be a Phase 1, randomized, single-blind, placebo-controlled, single and multiple ascending dose sequential group design in up to 48 healthy male Japanese subjects, performed at a single study center. The planned number of cohorts is 4 but up to 6 cohorts may be included if the Safety Review Committee (SRC) considers it necessary to repeat a dose level or if additional dose steps are required. Screening will be completed between Days -28 and -1. Primarily gradual escalation of the dose will be conducted with the oral suspension. Eight subjects will participate in each cohort. Four ascending dose levels are planned. Within each cohort 6 subjects will be randomised to receive AZD5718 and 2 subjects randomised to receive placebo. Each subject will receive one dose of AZD5718 or placebo on the first dosing day (Day 1, single ascending dose, SAD) and on Days 3 to 10 (multiple ascending dose, MAD). On Day 2 no dose will be given to the subject. In total each subject will receive 9 doses. Dosing for each ascending dose cohort will proceed after the SRC has evaluated the safety, tolerability and other relevant data of a completed cohort. The subjects will stay at the study site until 48 hours post-dose and will return 7 to 10 days after dosing for a follow-up visit. Each subject will be involved in the study for 7 weeks.","A Phase 1, Randomized, Single-blind, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD5718 After Single and Multiple Ascending Dose Administration to Healthy Japanese Men","D7550C00004","Coronary Artery Disease","Coronary Artery Disease|Coronary Disease","Heart Diseases","Cardiovascular","Experimental|Placebo Comparator","AZD5718|Placebo","Randomized subjects will receive orally once daily dose of AZD5718 oral suspension on Day 1 (SAD) and MAD from Days 3 to 10. On Day 2, no dose will be given. These procedures will be repeated in all cohorts.|Randomized subjects will receive orally once daily dose of placebo matching AZD5718 oral suspension on Day 1 (SAD) and MAD form Days 3 to 10. On Day 2, no dose will be given. These procedures will be repeated in all cohorts.","Drug","AZD5718 oral suspension|Placebo matching AZD5817 oral suspension","In all cohorts, randomized subjects will receive orally AZD5718 oral suspension SAD (60 mg) on Day 1 and MAD (180 mg, 360 mg and 600 mg) from Days 3 to 10. On Day 2, no dose will be given. In total each subject will receive 9 doses of AZD5718.|In all cohorts, randomized subjects will receive orally placebo matching AZD5718 oral suspension on Day 1 and from Days 3 to 10. On Day 2, no dose will be given.",null,"AZD5718|Placebo","\n\n 1. Provision of signed and dated, written informed consent prior to any study specific procedures\n 2. Healthy male Japanese subjects aged 18-50 years with suitable veins for cannulation or repeated venipuncture. A subject will be considered as Japanese if: * both of his parents and all grandparents are Japanese,\n     * he was born in Japan and have a Japanese passport, and\n     * he has not lived outside Japan for more than 10 years.\n    \n    \n 3. Have a body mass index (BMI) between 18 and 30 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg inclusive.\n 4. Provision of signed, written and dated informed consent for optional genetic/biomarker research. If a subject declines to participate in the genetic component of the study, there will be no penalty or loss of benefit to the subject. The subject will not be excluded from other aspects of the study described in this protocol.\n\n","\n\n 1.  History of any clinically important disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.\n 2.  History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs.\n 3.  Any clinically important illness, medical/surgical procedure or trauma within 4 weeks of the first administration of investigational medicinal product (IMP).\n 4.  Any clinically important abnormalities in clinical chemistry, hematology or urinalysis results as judged by the Investigator.\n 5.  Any positive result on Screening for serum hepatitis B surface antigen, hepatitis C antibody and human immunodeficiency virus (HIV).\n 6.  Suspicion or known Gilbert's syndrome.\n 7.  Abnormal vital signs, after 10 minutes supine rest, at screening and check-in, defined as any of the following (repeat evaluations may be done once if the values for a subject are outside the designated range at screening and on Day -1):Systolic blood pressure < 90 mmHg or > 140 mmHg Diastolic blood pressure < 50 mmHg or > 90 mmHg Heart rate < 45 or > 90 beats per minute (bpm)\n     \n     \n 8.  Any clinically important abnormalities in rhythm, conduction or morphology of the resting ECG and any clinically important abnormalities at screening and check-in in the 12-Lead ECG as considered by the Investigator that may interfere with the interpretation of QTc interval changes, including abnormal ST-T-wave morphology, particularly in the protocol defined primary lead or left ventricular hypertrophy. If deemed necessary, an ECG may be repeated once for each ECG measurement.\n 9.  Prolonged QTcF > 450 ms or shortened QTcF < 340 ms or family history of long QT syndrome at screening and check-in. If deemed necessary, an ECG may be repeated once for each ECG measurement.\n 10. PR(PQ) interval shortening < 120 ms (PR > 110 ms but < 120 ms is acceptable if there is no evidence of ventricular pre-excitation) at screening and check-in. If deemed necessary, an ECG may be repeated once for each ECG measurement.\n 11. PR (PQ) interval prolongation (> 240 ms) intermittent second (Wenckebach block while asleep is not exclusive) or third degree atrioventricular (AV) block, or AV dissociation at screening and check-in. If deemed necessary, an ECG may be repeated once for each ECG measurement.\n 12. Persistent or intermittent complete bundle branch block (BBB), incomplete bundle branch block (IBBB), or intraventricular conduction delay (IVCD) with QRS > 110 ms. Subjects with QRS > 110 ms but < 115 ms are acceptable if there is no evidence of e.g., ventricular hypertrophy or pre-excitation, at screening and check-in. If deemed necessary, an ECG may be repeated once for each ECG measurement.\n 13. Known or suspected history of drug abuse as judged by the Investigator.\n 14. Current smokers or those who have smoked or used nicotine products (including e-cigarettes within the previous 3 months).\n 15. History of alcohol abuse or excessive intake of alcohol as judged by the Investigator.\n 16. Positive screen for drugs of abuse or cotinine (nicotine) at screening and check-in (excluding cotinine).\n 17. History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity, as judged by the Investigator or history of hypersensitivity to drugs with a similar chemical structure or class to AZD5718.\n 18. Excessive intake of caffeine-containing drinks or food (e.g., coffee, tea, chocolate,) as judged by the Investigator.\n 19. Use of drugs with enzyme inducing properties such as St John's Wort within 3 weeks prior to the first administration of IMP.\n 20. Use of any prescribed or non-prescribed medication including antacids, analgesics (other than paracetamol/acetaminophen), herbal remedies, megadose vitamins (intake of 20 to 600 times the recommended daily dose) and minerals during the 2 weeks prior to the first administration of investigational product or longer if the medication has a long half-life.\n 21. Plasma donation within 1 month of Screening or any blood donation/blood loss > 500 mL during the 3 months prior to Screening.\n 22. Has received another new chemical entity (defined as a compound which has not been approved for marketing in the US) within 30 days or at least 5 half-lives (whichever is longer) of the first administration of investigational drug in this study. Note: subjects consented and screened, but not randomized in this study or a previous phase I study, are not excluded.\n 23. Subjects who have previously received AZD5718.\n 24. Involvement of any Astra Zeneca, PAREXEL or study site employee or their close relatives.\n 25. Judgment by the Investigator that the subject should not participate in the study if they have any ongoing or recent (i.e., during the Screening period) minor medical complaints that may interfere with the interpretation of study data or are considered unlikely to comply with study procedures, restrictions and requirements.\n 26. Subjects who are vegans or have medical dietary restrictions.\n 27. Subjects who cannot communicate reliably with the study team.\n 28. Vulnerable subjects, e.g., kept in detention, protected adults under guardianship, trusteeship, or committed to an institution by governmental or juridical order.In addition, any of the following is regarded as a criterion for exclusion from the genetic research:\n     \n     \n 29. Previous bone marrow transplant.\n 30. Non-leukocyte depleted whole blood transfusion within 120 days of the date of the genetic sample collection.",{"$nulls":4},"Actual","2018-01-17","Actual","Actual","2018-06-12","Actual","2018-06-01","2017-12-12","2018-01-10","2018-06-14","No","Coronary Artery Disease,\nCardiovascular disease (CAD),\n5-lipoxygenase activating protein (FLAP) inhibitor,\nLeukotrienes.","Interventional","Treatment","Parallel Assignment","Single (Participant)","Randomized","18 Years","50 Years","Male",null,"Yes",{"$nulls":4},"Yes","No",{"$nulls":19},"Number of patients with Adverse Events (AEs) due to AZD5817|Supine vital sign (Systolic Blood pressure [BP])|Supine vital sign (pulse rate)|Number of participants with abnormal findings in electrocardiograms (ECGs) (safety ECGs, digital ECGs [dECG])|Number of participants with abnormal cardiac telemetry|Number of participants with abnormal findings in physical examinations|Laboratory assessment: Hematology (leukocyte count)|Supine vital sign (diastolic BP)|Laboratory assessment: Clinical chemistry (sodium)|Laboratory assessment: Urinalysis (glucose)|Laboratory assessment: Hematology (Red blood cell [RBC] count)|Laboratory assessment: Hematology (Hemoglobin [Hb])|Laboratory assessment: Hematology (Hematocrit [HCT])|Laboratory assessment: Hematology (Mean corpuscular volume [MCV])|Laboratory assessment: Hematology (Mean corpuscular hemoglobin [MCH])|Laboratory assessment: Hematology (Mean corpuscular hemoglobin concentration [MCHC])|Laboratory assessment: Clinical chemistry (potassium)|Laboratory assessment: Clinical chemistry (urea)|Laboratory assessment: Clinical chemistry (creatinine)|Laboratory assessment: Clinical chemistry (albumin)|Laboratory assessment: Clinical chemistry (calcium)|Laboratory assessment: Clinical chemistry (phosphate)|Laboratory assessment: Clinical chemistry (glucose (fasting))|Laboratory assessment: Clinical chemistry (insulin)|Laboratory assessment: Clinical chemistry (fibrinogen)|Laboratory assessment: Clinical chemistry (thyroid-stimulating hormone)|Laboratory assessment: Urinalysis (blood)|Laboratory assessment: Urinalysis (protein)|Laboratory assessment: Urinalysis (urine creatinine)|Laboratory assessment: Hematology (Differential Count)|Laboratory assessment: Hematology (Platelets)|Laboratory assessment: Hematology (Reticulocytes absolute count)|Laboratory assessment: Clinical chemistry (High sensitivity-C-reactive protein [CRP])|Laboratory assessment: Clinical chemistry (Free T4)|Laboratory assessment: Clinical chemistry (Alkaline phosphatase [ALP])|Laboratory assessment: Clinical chemistry (Alanine aminotransferase [ALT])|Laboratory assessment: Clinical chemistry (Aspartate aminotransferase [AST])|Laboratory assessment: Clinical chemistry (Gamma glutamyl transpeptidase [GGT])|Laboratory assessment: Clinical chemistry (Total Bilirubin)|Laboratory assessment: Clinical chemistry (Unconjugated bilirubin)|Laboratory assessment: Clinical chemistry (Glutamate dehydrogenase)|Laboratory assessment: Clinical chemistry (Lactate dehydrogenase [LDH])","To assess the adverse events as a variable of safety and tolerability of AZD5718 following oral administration of single and multiple ascending doses. Adverse Events will be collected from the start of randomization throughout the treatment period up to and including the follow-up visit. Serious adverse events (SAEs) will be recorded from the time of informed consent.|To assess the vital sign as a variable of safety and tolerability variable of AZD5718 following oral administration of single and multiple ascending doses.|To assess the vital sign as a variable of safety and tolerability of AZD5718 following oral administration of single and multiple ascending doses.|To assess any clinically important abnormalities in the cardiovascular system functioning as a variable of safety and tolerability of AZD5718 following oral administration of single and multiple ascending doses. A 12-lead 10-second safety ECG will be performed with the Schiller Cardiovit CS-200 recorder immediately following all scheduled dECGs. 12-lead continuous dECG will be recorded over at least 5 minutes with the Schiller Cardiovit CS-200 recorder and transmitted to the AstraZeneca central dECG repository, according to AstraZeneca ECG CenterÂ´s standard procedures for settings, recording, and transmission of dECGs. For dECG, QTcF (QT interval corrected for heart rate using Fridericia's formula) will be calculated as QTcF =(QT*(RR/1000)^(-1/3)), where RR (the time between corresponding points on 2 consecutive R waves on ECG) is presented in milliseconds. Heart rate (HR) will also be calculated, based on the RR interval.|To assess any clinically important abnormalities in the cardiovascular system functioning (heart beat/rythm) using 2-lead real-time telemetry ECG as a variable of safety and tolerability of AZD5718 following oral administration of single and multiple ascending doses. The telemetry monitoring system will be reviewed by the Investigator or research nurse and paper printouts of any clinically important events will be stored as source data.|To assess any clinically important abnormal findings in physical conditions as a variable of safety and tolerability of AZD5718 following oral administration of single and multiple ascending doses. The complete physical examinations include an assessment of the general appearance, skin, cardiovascular, respiratory, abdomen, head, and neck (including ears, eyes, nose, and throat), lymph nodes, thyroid, musculoskeletal and neurological systems. The brief physical examinations include an assessment of the general appearance, skin, cardiovascular system, respiratory and abdomen. Any new or aggravated clinically relevant abnormal medical finding at a physical examination as compared with the baseline assessment will be reported as an adverse event.|To assess the leukocyte count as a variable of safety and tolerability of AZD5718 following oral administration of single and multiple ascending doses.|To assess the clinical chemistry value (sodium) as a variable of safety and tolerability of AZD5718, following oral administration of single and multiple ascending doses.|To assess urinalysis (glucose) as a variable of safety and tolerability of AZD5718, following oral administration of single and multiple ascending doses.|To assess the RBC count as a variable of safety and tolerability of AZD5718 following oral administration of single and multiple ascending doses.|To assess the Hb as a criterion of safety and tolerability variable of AZD5718 following oral administration of single and multiple ascending doses.|To assess the HCT as a variable of safety and tolerability of AZD5718 following oral administration of single and multiple ascending doses.|To assess the MCV as a variable of safety and tolerability of AZD5718 following oral administration of single and multiple ascending doses.|To assess the MCH as a variable of safety and tolerability of AZD5718 following oral administration of single and multiple ascending doses.|To assess the MCHC as a variable of safety and tolerability variable of AZD5718 following oral administration of single and multiple ascending doses.|To assess the clinical chemistry value (potassium) as a variable of safety and tolerability of AZD5718, following oral administration of single and multiple ascending doses.|To assess the clinical chemistry value (urea) as a variable of safety and tolerability of AZD5718, following oral administration of single and multiple ascending doses.|To assess the clinical chemistry value (creatinine) as a variable of safety and tolerability of AZD5718, following oral administration of single and multiple ascending doses.|To assess the clinical chemistry value (albumin) as a variable of safety and tolerability of AZD5718, following oral administration of single and multiple ascending doses.|To assess the clinical chemistry value (calcium) as a variable of safety and tolerability of AZD5718, following oral administration of single and multiple ascending doses.|To assess the clinical chemistry value (phosphate) as a variable of safety and tolerability of AZD5718, following oral administration of single and multiple ascending doses.|To assess the clinical chemistry value (glucose (fasting)) as a variable of safety and tolerability of AZD5718, following oral administration of single and multiple ascending doses.|To assess the clinical chemistry value (insulin) as a variable of safety and tolerability of AZD5718, following oral administration of single and multiple ascending doses.|To assess the clinical chemistry value (fibrinogen) as a variable of safety and tolerability of AZD5718, following oral administration of single and multiple ascending doses.|To assess the clinical chemistry value (thyroid-stimulating hormone) as a variable of safety and tolerability of AZD5718, following oral administration of single and multiple ascending doses.|To assess urinalysis (blood) as a variable of safety and tolerability of AZD5718, following oral administration of single and multiple ascending doses. If urinalysis is positive for blood, a microscopy test will be performed to assess RBC, white blood cell|To assess urinalysis (protein) as a variable of safety and tolerability of AZD5718, following oral administration of single and multiple ascending doses. If urinalysis is positive for protein, a microscopy test will be performed to assess RBC, WBC, casts|To assess urinalysis (urine creatinine) as a variable of safety and tolerability of AZD5718, following oral administration of single and multiple ascending doses.|To assess the differential count as a variable of safety and tolerability of AZD5718 following oral administration of single and multiple ascending doses.|To assess the platelets as a variable of safety and tolerability of AZD5718 following oral administration of single and multiple ascending doses.|To assess the reticulocytes absolute count as a variable of safety and tolerability of AZD5718 following oral administration of single and multiple ascending doses.|To assess the clinical chemistry value (CRP) as a variable of safety and tolerability of AZD5718, following oral administration of single and multiple ascending doses.|To assess the clinical chemistry value (Free T4) as a variable of safety and tolerability of AZD5718, following oral administration of single and multiple ascending doses.|To assess the clinical chemistry value (ALP) as a variable of safety and tolerability of AZD5718, following oral administration of single and multiple ascending doses.|To assess the clinical chemistry value (ALT) as a variable of safety and tolerability of AZD5718, following oral administration of single and multiple ascending doses.|To assess the clinical chemistry value (AST) as a variable of safety and tolerability of AZD5718, following oral administration of single and multiple ascending doses.|To assess the clinical chemistry value (GGT) as a variable of safety and tolerability of AZD5718, following oral administration of single and multiple ascending doses.|To assess the clinical chemistry value (total bilirubin) as a variable of safety and tolerability of AZD5718, following oral administration of single and multiple ascending doses.|To assess the clinical chemistry value (unconjugated bilirubin) as a variable of safety and tolerability of AZD5718, following oral administration of single and multiple ascending doses.|To assess the clinical chemistry value (glutamate dehydrogenase) as a variable of safety and tolerability of AZD5718, following oral administration of single and multiple ascending doses.|To assess the clinical chemistry value (LDH) as a variable of safety and tolerability of AZD5718, following oral administration of single and multiple ascending doses.","Change from baseline up to follow-up (7 to 10 days post-(final) dose)|From baseline up to follow-up (7 to 10 days post-(final) dose). For dECG: Days 1 to 12|From baseline up to Day 10|From baseline up to follow-up (7 to 10 days post-(final) dose)|WBC, casts|cellular, granular, hyaline).","Plasma PK assessment: Observed maximum plasma concentration (Cmax) assessment for AZD5817 after single and repeated oral dosing|Plasma PK assessment: Time to reach peak or maximum observed concentration following drug administration (tmax) assessment for AZD5817 after single and repeated oral dosing|Plasma PK assessment: Terminal rate constant (Î»Z) assessment for AZD5817 after single and repeated oral dosing|Plasma PK assessment: Terminal half-life (tÂ½Î»z) assessment for AZD5817 after single and repeated oral dosing|Plasma PK assessment: Area under the plasma concentration-time curve from time zero to 24 hours after dosing (AUC(0-24)) assessment for AZD5817 after single and repeated oral dosing|Plasma PK assessment: Area under the plasma concentration-curve from time zero to the time of last quantifiable analyte concentration (AUC(0-last)) assessment for AZD5817 after single and repeated oral dosing|Plasma PK assessment: Area under the plasma concentration-curve over the dosing interval (AUC(0-Ï„)) assessment for AZD5817 after single and repeated oral dosing|Plasma PK assessment: Area under the concentration-time curve from time zero extrapolated to infinity (AUC) assessment for AZD5817 after single and repeated oral dosing|Plasma PK assessment: Apparent total body clearance of drug from plasma after extravascular administration (CL/F) assessment for AZD5817 after single and repeated oral dosing|Plasma PK assessment: Mean Residence Time (MRT) assessment for AZD5817 after single and repeated oral dosing|Plasma PK assessment: Apparent volume of distribution for parent drug at terminal phase (extravascular administration), (Vz/F) assessment for AZD5817 after single and repeated oral dosing|Plasma PK assessment: Observed minimum concentration, (Cmin) assessment for AZD5817 after single and repeated oral dosing (Day 10)|Plasma PK assessment: Observed average concentration (Cavg) assessment for AZD5817 after single and repeated oral dosing (Day 10)|Plasma PK assessment: Accumulation ratio (Rac Cmax) assessment for AZD5817 after single and repeated oral dosing|Plasma PK assessment: Accumulation ratio (Rac AUC) assessment for AZD5817 after single and repeated oral dosing|Plasma PK assessment: Temporal change parameter in systemic exposure (TCP) assessment for AZD5817 after single and repeated oral dosing|Urine PK assessment: Cumulative amount of unchanged drug excreted in urine from time zero to the last sampling interval (Ae(0-last)) assessment for AZD5817 after single and repeated oral dosing|Urine PK assessment: Fraction of dose excreted unchanged into the urine from time zero to the last sampling interval measured time point for an analyte (Fe(0-last)) assessment for AZD5817 after single and repeated oral dosing|Urine PK assessment: Renal clearance of drug from plasma (CLR) assessment for AZD5817 after single and repeated oral dosing|PD parameter: urine Leukotriene E4 (LTE4) assessment for AZD5817 after single and repeated oral dosing","To assess Cmax of AZD5718 after single and repeated oral dosing.|To assess tmax of AZD5718 after single and repeated oral dosing.|To assess Î»Z of AZD5718 after single and repeated oral dosing. Î»Z will be estimated by log-linear least-squares regression of the terminal part of the concentration-time curve.|To assess tÂ½Î»z of AZD5718 after single and repeated oral dosing. tÂ½Î»z will be estimated as (ln2)/Î»Z.|To assess AUC(0-24) of AZD5718 after single and repeated oral dosing.|To assess AUC(0-last) of AZD5718 after single and repeated oral dosing.|To assess AUC(0-Ï„) of AZD5718 after single and repeated oral dosing.|To assess AUC of AZD5718 after single and repeated oral dosing. AUC is estimated by AUC(0-last) + Clast/Î»Z where Clast is the last observed quantifiable concentration.|To assess CL/F of AZD5718 after single and repeated oral dosing.|To assess MRT of AZD5718 after single and repeated oral dosing.|To assess Vz/F of AZD5718 after single and repeated oral dosing. Vz/F will be estimated by dividing the apparent clearance (CL/F) by Î»Z.|To assess Cmin of AZD5718 after single and repeated oral dosing. Cmin will be taken directly from the individual concentration-time curve.|To assess Cavg of AZD5718 after single and repeated oral dosing. Cavg will be taken directly from the individual concentration-time curve.|To assess Rac Cmax of AZD5718 after single and repeated oral dosing. Rac Cmax will be calculated as Cmax Day 10/ Cmax Day 1.|To assess Rac AUC of AZD5718 after single and repeated oral dosing. Rac AUC will be calculated as AUCÏ„ Day 10/ AUCÏ„ Day 1.|To assess TCP of AZD5718 after single and repeated oral dosing. TCP will be calculated as AUCÏ„Day 10/AUCDay 1.|To assess Ae(0-last) of AZD5718 after single and repeated oral dosing.|To assess Fe(0-last) of AZD5718 after single and repeated oral dosing. Fe(0-last) will be estimated by dividing Ae(0-last) by dose.|To assess CLR of AZD5718 after single and repeated oral dosing. CLR will be estimated by dividing Ae(0-last) by AUC(0-t)).|To evaluate the PD of AZD5718, by assessment of urine LTE4 (u-LTE4), after single and repeated oral dosing.","Day 1 and Day 10: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 32 and 48 hours (Day 3 pre-dose) post-dose, Day 4-9 pre morning dose|Day 1 and Day 10: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 32 and 48 hours (Day 3 pre-dose) post-dose|Day 10: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 32 and 48 hours (Day 3 pre-dose) post-dose|Day 10 pooled 0-3, 3-6, 6-9, 9-12 hours and 12-24 hours urine|Day -1 (spot sample), Day 1 and Day 10 spot sample pre-dose and pooled 0-3, 3-6, 6-9 and 9-12 hours urine, spot sample at 24, 36 hours post-dose, Day 3-9: spot sample pre-dose",{"$nulls":3},"Glendale, California, United States, 91206","California","United States","Research Site",{"$nulls":4},"2018-06-14","2020-05-25T16:37:05.384","2020-05-26T17:10:42.972","NCT03400488"]
["5ecbf433307e3d1b1f8d9d0f","NCT03400800","2019-04-17","The Medicines Company","MDCO","Active, not recruiting","Inclisiran for Subjects With ACSVD or ACSVD-Risk Equivalents and Elevated Low-density Lipoprotein Cholesterol (ORION-11)","Inclisiran",null,"Yes","['Inclisiran']","Unknown",null,"Phase 3",2,1617,"Actual","2017-11-01","2019-10-01",{"$nulls":5},"This is a Phase III, placebo-controlled, double-blind, randomized study in participants with ASCVD or ASCVD-Risk equivalents and elevated LDL-C despite maximum tolerated dose of LDL-C lowering therapies to evaluate the efficacy, safety, and tolerability of subcutaneous (SC) inclisiran injection(s). The study will be an international multicenter study (non-United States).",null,"A Placebo-Controlled, Double-Blind, Randomized Trial to Evaluate the Effect of 300 mg of Inclisiran Sodium Given as Subcutaneous Injections in Subjects With Atherosclerotic Cardiovascular Disease (ASCVD) or ACSVD Risk-Equivalents and Elevated Low-Density Lipoprotein Cholesterol (LDL-C)","MDCO-PCS-17-08","ASCVD\nElevated Cholesterol",{"$nulls":3},"Experimental|Placebo Comparator","Inclisiran|Saline Solution","Inclisiran sodium 300 milligrams (mg) (equivalent to 284 mg inclisiran) in 1.5 milliliters (mL) will be administered as a SC injection on Day 1, Day 90, and then every 6 months|Placebo (1.5 mL) will be administered as a SC injection of saline solution on Day 1, Day 90, and then every 6 months","Drug","Inclisiran Sodium|Placebo","Inclisiran is a small interfering ribonucleic acid (RNA) that inhibits PCSK9 synthesis.|Placebo will be supplied as sterile normal saline (0.9% sodium chloride in water for injection).","Saline Solution","Inclisiran|Saline Solution","\n\nParticipants may be included if they meet all of the following inclusion criteria prior to randomization:\n\n 1. Male or female participants â‰¥18 years of age.\n 2. History of ASCVD (coronary heart disease [CHD], cardiovascular disease [CVD], or peripheral arterial disease [PAD]).\n 3. Serum LDL-C â‰¥1.8 millimole (mmol)/liter (L) (â‰¥70 mg/dL).\n 4. Fasting triglyceride <4.52 mmol/L (<400 mg/dL) at screening.\n 5. Participants on statins should be receiving a maximally tolerated dose.\n 6. Participants not receiving statins must have documented evidence of intolerance to all doses of at least 2 different statins.\n 7. Subjects on lipid-lower therapies (such as a statin and/or ezetimibe) should be on a stable dose for â‰¥30 days before screening with no planned medication or dose change during study participation.\n\n","\n\nParticipants will be excluded from the study if any of the following exclusion criteria apply prior to randomization:\n\n 1. New York Heart Association (NYHA) class IV heart failure.\n 2. Uncontrolled cardiac arrhythmia.\n 3. Uncontrolled severe hypertension.\n 4. Active liver disease.\n 5. Females who are pregnant or nursing, or who are of childbearing potential and unwilling to use at least 2 methods of highly effective contraception (failure rate less than 1% per year) (for example, combined oral contraceptives, barrier methods, approved contraceptive implant, long-term injectable contraception, or intrauterine device) for the entire duration of the study. Exemptions from this criterion: 1. Women >2 years postmenopausal (defined as 1 year or longer since last menstrual period) and more than 55 years of age.\n     2. Postmenopausal women (as defined above) and less than 55 years of age with a negative pregnancy test within 24 hours of randomization.\n     3. Women who are surgically sterilized at least 3 months prior to enrollment.\n    \n    \n 6. Males who are unwilling to use an acceptable method of birth control during the entire study period (such as condom with spermicide).\n 7. Treatment with other investigational products or devices within 30 days or 5 half-lives of the screening visit, whichever is longer.\n 8. Treatment (within 90 days of screening) with monoclonal antibodies directed towards PCSK9.\n\nThe above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.",{"$nulls":4},"Actual","2018-01-17","Actual","Anticipated","2019-12-01","Anticipated","2019-04-01","2018-01-09","2018-01-09","2019-04-15","Yes","Inclisiran sodium\nASCVD\nLDL-C","Interventional","Treatment","Parallel Assignment","Double (Participant, Care Provider)","Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":19},"Percentage Change in LDL-C from Baseline to Day 510|Time-adjusted Percent Change in LDL-C Levels from Baseline after Day 90 and up to Day 540","Baseline, Day 510|Baseline, Day 90, Day 540",null,"Absolute Change In LDL-C from Baseline To Day 510|Time-adjusted Absolute Change in LDL-C from Baseline after Day 90 and up to Day 540|Percentage Change in Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) from Baseline to Day 510|Percentage Change in Total Cholesterol from Baseline to Day 510|Percentage Change in Apolipoprotein B (ApoB) from Baseline to Day 510|Percentage Change in Non-HDL-C from Baseline to Day 510","Baseline, Day 510|Baseline, Day 90, Day 540",{"$nulls":4},"Chomutov, Czechia, 43001 Research Site 11420-003UherskÃ© HradiÅ¡tÄ›, Czechia, 68601|Berlin, Germany, 12567 Research Site 11049-002Bochum, Germany, 44787 Research Site 11049-003Frankfurt, Germany, 60313 Research Site 11049-007Heidelberg, Germany, 69120 Research Site 11049-001Leipzig, Germany, 4103|Budapest, Hungary, 1036 Research Site 11036-004Debrecen, Hungary, 4025 Research Site 11036-002Hatvan, Hungary, 3000 Research Site 11036-003Zalaegerszeg, Hungary, 8900|Bydgoszcz, Kujawsko-Pomorskie, Poland, 85-079|BrzozÃ³w, Podkarpackie, Poland, 36-200|Bydgoszcz, Poland, 85-231 Research Site 11048-004GdaÅ„sk, Poland, 80-382 Research Site 11048-017GdaÅ„sk, Poland, 80-542 Research Site 11048-005Gdynia, Poland, 81-537 Research Site 11048-007Katowice, Poland, 04-040 Research Site 11048-012Katowice, Poland, 40-648 Research Site 11048-014KrakÃ³w, Poland, 31-216 Research Site 11048-003KrakÃ³w, Poland, 31-501 Research Site 11048-008Lublin, Poland, 20-709 Research Site 11048-001PoznaÅ„, Poland, 60-702 Research Site 11048-013RzeszÃ³w, Poland, 35-055 Research Site 11048-015TarnÃ³w, Poland, 33-100 Research Site 11048-009Warsaw, Poland, 04-628 Research Site 11048-006Warszawice, Poland, 01-192 Research Site 11048-002WrocÅ‚aw, Poland, 50-381 Research Site 11048-010WrocÅ‚aw, Poland, 51-314|Ruda ÅšlÄ…ska, Slaskie, Poland, 41-709|Bloemfontein, Free State, South Africa, 9301|Johannesburg, Gauteng, South Africa, 1619|Cape Town, Western Cape, South Africa, 7500 Research Site 11027-013Cape Town, Western Cape, South Africa, 7646 Research Site 11027-007Kuilsrivier, Western Cape, South Africa, 7130 Research Site 11027-004Somerset West, Western Cape, South Africa, 7130|Pretoria, South Africa, 184 Research Site 11027-011Welkom, South Africa, 9459|Cherkasy, Ukraine, 18009 Research Site - 11380-008Kharkiv, Ukraine, 61444 Research Site - 11380-004Kiev, Ukraine, 3115 Research Site - 11380-009Kiev, Ukraine, 3115 Research Site - 11380-001Kyiv, Ukraine, 2002 Research Site - 11380-002Kyiv, Ukraine, 3037 Research Site - 11380-003Kyiv, Ukraine, 3049 Research Site - 11380-007Lviv, Ukraine, 79060 Research Site - 11380-006Uzhhorod, Ukraine, 8800|Edgbaston, Birmingham, United Kingdom, B15 2Sq|Sale, Cheshire, United Kingdom, M33 2Rh Research Site - 11044-023Sale, Cheshire, United Kingdom, M33 4Br Research Site - 11044-021Timperley, Cheshire, United Kingdom, Wa14 5Pf|Liskeard, Cornwall, United Kingdom, Pl14 3Xa|Exeter, Devon, United Kingdom, Ex2 5Dw Research Site - 11044-019Plymouth, Devon, United Kingdom, Pl5 3Jb|Chorley, Lancashire, United Kingdom, Pr7 7Na|Waterloo, Liverpool, United Kingdom, L22 0Lg|Davyhulme, Manchester, United Kingdom, M41 7Wj|Bollington, United Kingdom, Sk10 5Jh Research Site - 11044-026Bury, United Kingdom, Bl9 Onj Research Site - 11044-007Cardiff, United Kingdom, Cf15 9Ss Research Site - 11044-024Cheadle Hulme, United Kingdom, Sk8 5Ll Research Site - 11044-010Derby, United Kingdom, S40 4Aa Research Site - 11044-001Glasgow, United Kingdom, G20 0Sp Research Site - 11044-008Hexham, United Kingdom, Ne46 1Qj Research Site - 11044-020Macclesfield, United Kingdom, Sk11 6Jl Research Site - 11044-025Manchester, United Kingdom, M14 6Wp Research Site - 11044-005Manchester, United Kingdom, M15 6Sx Research Site - 11044-029Manchester, United Kingdom, M20 2Rn Research Site - 11044-003Reading, United Kingdom, Rg2 0Tg Research Site - 11044-002Stockton, United Kingdom, Ts19 8Pe",null,"Czechia|Germany|Hungary|Poland|South Africa|Ukraine|United Kingdom","Research Site 11420-002|Research Site 11049-006|Research Site 11036-001|Kujawsko-Pomorskie Research Site 11048-018|Podkarpackie Research Site 11048-016|Research Site 11048-011|Slaskie Research Site 11048-019|, Free State Research Site 11027-003|, Gauteng Research Site 11027-005|, Western Cape Research Site 11027-001|Research Site 11027-006|Research Site - 11380-005|, Birmingham Research Site - 11044-006|, Cheshire Research Site - 11044-022|, Cornwall Research Site - 11044-012|, Devon Research Site - 11044-009|, Lancashire Research Site - 11044-014|, Liverpool Research Site - 11044-004|, Manchester Research Site - 11044-027|Research Site - 11044-028",{"$nulls":4},"2019-04-15","2020-05-25T16:37:07.420","2020-05-26T17:10:42.972","NCT03400800"]
["5ecbf43311702c1b1b916a8f","NCT03400800","2019-09-17","The Medicines Company","MDCO","Completed","Inclisiran for Subjects With ACSVD or ACSVD-Risk Equivalents and Elevated Low-density Lipoprotein Cholesterol (ORION-11)","Inclisiran",null,"Yes","['Inclisiran']","Unknown",null,"Phase 3",2,1617,"Actual","2017-11-01","2019-07-31",{"$nulls":5},"This is a Phase III, placebo-controlled, double-blind, randomized study in participants with ASCVD or ASCVD-Risk equivalents and elevated LDL-C despite maximum tolerated dose of LDL-C lowering therapies to evaluate the efficacy, safety, and tolerability of subcutaneous (SC) inclisiran injection(s). The study will be an international multicenter study (non-United States).",null,"A Placebo-Controlled, Double-Blind, Randomized Trial to Evaluate the Effect of 300 mg of Inclisiran Sodium Given as Subcutaneous Injections in Subjects With Atherosclerotic Cardiovascular Disease (ASCVD) or ACSVD Risk-Equivalents and Elevated Low-Density Lipoprotein Cholesterol (LDL-C)","MDCO-PCS-17-08","ASCVD\nRisk Factor, Cardiovascular\nElevated Cholesterol",{"$nulls":3},"Experimental|Placebo Comparator","Inclisiran|Saline Solution","Inclisiran sodium 300 milligrams (mg) (equivalent to 284 mg inclisiran) in 1.5 milliliters (mL) will be administered as a SC injection on Day 1, Day 90, and then every 6 months|Placebo (1.5 mL) will be administered as a SC injection of saline solution on Day 1, Day 90, and then every 6 months","Drug","Inclisiran Sodium|Placebo","Inclisiran is a small interfering ribonucleic acid (RNA) that inhibits PCSK9 synthesis.|Placebo will be supplied as sterile normal saline (0.9% sodium chloride in water for injection).","Saline Solution","Inclisiran|Saline Solution","\n\nParticipants may be included if they meet all of the following inclusion criteria prior to randomization:\n\n 1. Male or female participants â‰¥18 years of age.\n 2. History of ASCVD (coronary heart disease [CHD], cardiovascular disease [CVD], or peripheral arterial disease [PAD]).\n 3. Serum LDL-C â‰¥1.8 millimole (mmol)/liter (L) (â‰¥70 mg/dL).\n 4. Fasting triglyceride <4.52 mmol/L (<400 mg/dL) at screening.\n 5. Participants on statins should be receiving a maximally tolerated dose.\n 6. Participants not receiving statins must have documented evidence of intolerance to all doses of at least 2 different statins.\n 7. Subjects on lipid-lower therapies (such as a statin and/or ezetimibe) should be on a stable dose for â‰¥30 days before screening with no planned medication or dose change during study participation.\n\n","\n\nParticipants will be excluded from the study if any of the following exclusion criteria apply prior to randomization:\n\n 1. New York Heart Association (NYHA) class IV heart failure.\n 2. Uncontrolled cardiac arrhythmia.\n 3. Uncontrolled severe hypertension.\n 4. Active liver disease.\n 5. Females who are pregnant or nursing, or who are of childbearing potential and unwilling to use at least 2 methods of highly effective contraception (failure rate less than 1% per year) (for example, combined oral contraceptives, barrier methods, approved contraceptive implant, long-term injectable contraception, or intrauterine device) for the entire duration of the study. Exemptions from this criterion: 1. Women >2 years postmenopausal (defined as 1 year or longer since last menstrual period) and more than 55 years of age.\n     2. Postmenopausal women (as defined above) and less than 55 years of age with a negative pregnancy test within 24 hours of randomization.\n     3. Women who are surgically sterilized at least 3 months prior to enrollment.\n    \n    \n 6. Males who are unwilling to use an acceptable method of birth control during the entire study period (such as condom with spermicide).\n 7. Treatment with other investigational products or devices within 30 days or 5 half-lives of the screening visit, whichever is longer.\n 8. Treatment (within 90 days of screening) with monoclonal antibodies directed towards PCSK9.\n\nThe above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.",{"$nulls":4},"Actual","2018-01-17","Actual","Actual","2019-08-27","Actual","2019-09-01","2018-01-09","2018-01-09","2019-09-16","Yes","Inclisiran sodium\nASCVD\nLDL-C","Interventional","Treatment","Parallel Assignment","Double (Participant, Care Provider)","Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":19},"Percentage Change in LDL-C from Baseline to Day 510|Time-adjusted Percent Change in LDL-C Levels from Baseline after Day 90 and up to Day 540","Baseline, Day 510|Baseline, Day 90, Day 540",null,"Absolute Change In LDL-C from Baseline To Day 510|Time-adjusted Absolute Change in LDL-C from Baseline after Day 90 and up to Day 540|Percentage Change in Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) from Baseline to Day 510|Percentage Change in Total Cholesterol from Baseline to Day 510|Percentage Change in Apolipoprotein B (ApoB) from Baseline to Day 510|Percentage Change in Non-HDL-C from Baseline to Day 510","Baseline, Day 510|Baseline, Day 90, Day 540",{"$nulls":4},"Chomutov, Czechia, 43001 Research Site 11420-003UherskÃ© HradiÅ¡tÄ›, Czechia, 68601|Berlin, Germany, 12567 Research Site 11049-002Bochum, Germany, 44787 Research Site 11049-003Frankfurt, Germany, 60313 Research Site 11049-007Heidelberg, Germany, 69120 Research Site 11049-001Leipzig, Germany, 4103|Budapest, Hungary, 1036 Research Site 11036-004Debrecen, Hungary, 4025 Research Site 11036-002Hatvan, Hungary, 3000 Research Site 11036-003Zalaegerszeg, Hungary, 8900|Bydgoszcz, Kujawsko-Pomorskie, Poland, 85-079|BrzozÃ³w, Podkarpackie, Poland, 36-200|Bydgoszcz, Poland, 85-231 Research Site 11048-004GdaÅ„sk, Poland, 80-382 Research Site 11048-017GdaÅ„sk, Poland, 80-542 Research Site 11048-005Gdynia, Poland, 81-537 Research Site 11048-007Katowice, Poland, 04-040 Research Site 11048-012Katowice, Poland, 40-648 Research Site 11048-014KrakÃ³w, Poland, 31-216 Research Site 11048-003KrakÃ³w, Poland, 31-501 Research Site 11048-008Lublin, Poland, 20-709 Research Site 11048-001PoznaÅ„, Poland, 60-702 Research Site 11048-013RzeszÃ³w, Poland, 35-055 Research Site 11048-015TarnÃ³w, Poland, 33-100 Research Site 11048-009Warsaw, Poland, 04-628 Research Site 11048-006Warszawice, Poland, 01-192 Research Site 11048-002WrocÅ‚aw, Poland, 50-381 Research Site 11048-010WrocÅ‚aw, Poland, 51-314|Ruda ÅšlÄ…ska, Slaskie, Poland, 41-709|Bloemfontein, Free State, South Africa, 9301|Johannesburg, Gauteng, South Africa, 1619|Cape Town, Western Cape, South Africa, 7500 Research Site 11027-013Cape Town, Western Cape, South Africa, 7646 Research Site 11027-007Kuilsrivier, Western Cape, South Africa, 7130 Research Site 11027-004Somerset West, Western Cape, South Africa, 7130|Pretoria, South Africa, 184 Research Site 11027-011Welkom, South Africa, 9459|Cherkasy, Ukraine, 18009 Research Site - 11380-008Kharkiv, Ukraine, 61444 Research Site - 11380-004Kiev, Ukraine, 3115 Research Site - 11380-009Kiev, Ukraine, 3115 Research Site - 11380-001Kyiv, Ukraine, 2002 Research Site - 11380-002Kyiv, Ukraine, 3037 Research Site - 11380-003Kyiv, Ukraine, 3049 Research Site - 11380-007Lviv, Ukraine, 79060 Research Site - 11380-006Uzhhorod, Ukraine, 8800|Edgbaston, Birmingham, United Kingdom, B15 2Sq|Sale, Cheshire, United Kingdom, M33 2Rh Research Site - 11044-023Sale, Cheshire, United Kingdom, M33 4Br Research Site - 11044-021Timperley, Cheshire, United Kingdom, Wa14 5Pf|Liskeard, Cornwall, United Kingdom, Pl14 3Xa|Exeter, Devon, United Kingdom, Ex2 5Dw Research Site - 11044-019Plymouth, Devon, United Kingdom, Pl5 3Jb|Chorley, Lancashire, United Kingdom, Pr7 7Na|Waterloo, Liverpool, United Kingdom, L22 0Lg|Davyhulme, Manchester, United Kingdom, M41 7Wj|Bollington, United Kingdom, Sk10 5Jh Research Site - 11044-026Bury, United Kingdom, Bl9 Onj Research Site - 11044-007Cardiff, United Kingdom, Cf15 9Ss Research Site - 11044-024Cheadle Hulme, United Kingdom, Sk8 5Ll Research Site - 11044-010Derby, United Kingdom, S40 4Aa Research Site - 11044-001Glasgow, United Kingdom, G20 0Sp Research Site - 11044-008Hexham, United Kingdom, Ne46 1Qj Research Site - 11044-020Macclesfield, United Kingdom, Sk11 6Jl Research Site - 11044-025Manchester, United Kingdom, M14 6Wp Research Site - 11044-005Manchester, United Kingdom, M15 6Sx Research Site - 11044-029Manchester, United Kingdom, M20 2Rn Research Site - 11044-003Reading, United Kingdom, Rg2 0Tg Research Site - 11044-002Stockton, United Kingdom, Ts19 8Pe",null,"Czechia|Germany|Hungary|Poland|South Africa|Ukraine|United Kingdom","Research Site 11420-002|Research Site 11049-006|Research Site 11036-001|Kujawsko-Pomorskie Research Site 11048-018|Podkarpackie Research Site 11048-016|Research Site 11048-011|Slaskie Research Site 11048-019|, Free State Research Site 11027-003|, Gauteng Research Site 11027-005|, Western Cape Research Site 11027-001|Research Site 11027-006|Research Site - 11380-005|, Birmingham Research Site - 11044-006|, Cheshire Research Site - 11044-022|, Cornwall Research Site - 11044-012|, Devon Research Site - 11044-009|, Lancashire Research Site - 11044-014|, Liverpool Research Site - 11044-004|, Manchester Research Site - 11044-027|Research Site - 11044-028",{"$nulls":4},"2019-09-16","2020-05-25T16:37:07.795","2020-05-26T17:10:42.972","NCT03400800"]
["5ecbf434feab101b155308b0","NCT03400852","2018-02-28","Mallinckrodt","MNK","Recruiting","A Study to Assess the Efficacy and Safety of MNK-1411 in Duchenne Muscular Dystrophy (BRAVE)","Cosyntropin","Corticosteroid Secretion Stimulant","No",null,"No",null,"Phase 2",4,132,"Anticipated","2018-03-01","2020-08-01",{"$nulls":5},"This is a multicenter, double blind, placebo controlled, multiple dose study to examine the safety and efficacy of MNK-1411 in male subjects 4 to 8 years of age (inclusive) with Duchenne Muscular Dystrophy (DMD).",null,"A Multicenter, Randomized, Parallel Group, Double Blind, Multiple Dose, Placebo Controlled Study to Assess the Efficacy and Safety of MNK-1411 in Male Subjects 4 to 8 Years of Age With Duchenne Muscular Dystrophy","MNK14112096","Muscular Dystrophy, Duchenne","Muscular Dystrophy, Duchenne","Muscular Diseases","Musculoskeletal","Experimental|Placebo Comparator","Treatment A, MNK1411 High Dose|Treatment B, MNK1411 Low Dose|Treatment C, Placebo High Dose|Treatment D, Placebo Low Dose","Cosyntropin suspension 0.5/0.4 mL for up to 48 weeks|Cosyntropin suspension 0.25/0.2 mL for up to 48 weeks|Placebo suspension 0.4/0.5 mL for up to 24 weeks|Placebo suspension 0.25/0.2 mL for up to 24 weeks","Drug","Cosyntropin|Placebo","Suspension administered subcutaneously 2X week","MNK1411","Treatment A, MNK1411 High Dose|Treatment B, MNK1411 Low Dose|Treatment C, Placebo High Dose|Treatment D, Placebo Low Dose","\n\n 1. Subjects must have a documented diagnosis of Duchenne Muscular Dystrophy (DMD) confirmed by complete dystrophin deficiency (by immunofluorescence and/or immunoblot), or identifiable mutation in the DMD gene where reading frame can be predicated as \"out of frame,\" or complete dystrophin gene sequencing consistent with DMD; AND in the opinion of the Investigator, a typical clinical profile consistent with DMD.\n 2. Subjects taking approved treatments for DMD (by a Health Authority) that target dystrophin gene mutations (eg, eteplirsen or ataluren) may be enrolled in the study if they have been on a stable dose for 30 days prior to the first dose of study drug, and plan to remain on that dose throughout the study\n\n","\n\n 1. Subject has had previous systemic treatment with corticosteroids. Transient previous use of corticosteroids will be evaluated on a case-by-case basis by the sponsor or designee. Inhaled corticosteroids will be permitted if given at a stable dose for the 3 months prior to the first dose of study drug and the subject will remain on that dose throughout the study. The use of topical or intra-articular corticosteroids is permitted during the study.\n 2. Subject has symptomatic cardiomyopathy in the opinion of the investigator.\n 3. Subject is unable to complete the 10 meter Walk/Run test at the Screening and/or Baseline Visit.\n 4. Subject has Type 1 or Type 2 diabetes mellitus.\n 5. Subject has a history of chronic active hepatitis including acute or chronic hepatitis B, or acute or chronic hepatitis C.\n 6. Subject has a history of tuberculosis (TB) infection, any signs/symptoms of TB, or any close contact with an individual with an active TB infection.\n 7. Subject has known immune compromised status (not related to disease/condition under study), including but not limited to, individuals who have undergone organ transplantation or who are known to be positive for the human immunodeficiency virus.",{"$nulls":4},"Actual","2018-01-17","Actual","Anticipated","2020-08-01","Anticipated","2018-02-01","2018-01-09","2018-01-09","2018-02-26","Yes",null,"Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","4 Years","8 Years","Male",null,"No",{"$nulls":4},"Yes","No",{"$nulls":19},"10 meter walk/run","Motor performance test","24 weeks","NorthStar Ambulatory Assessment|4 stair climb|Rise from supine test|Quantitative muscle testing","Motor performance battery|Motor performance test|Strength-knee flexion and extension measured in Newtons, using a dynamometer","24 weeks","clinicaltrials@mnk.com","Sean Ma","800-556-3314","Atlanta, Georgia, United States, 30318|Las Vegas, Nevada, United States, 89145","Georgia|Nevada","United States","Rare Disease Research, Llc|Las Vegas Clinic",{"$nulls":4},"2018-02-26","2020-05-25T16:37:08.054","2020-05-26T17:10:42.972","NCT03400852"]
["5ecbf434fe30261b1a04827f","NCT03400852","2018-08-03","Mallinckrodt","MNK","Recruiting","A Study to Assess the Efficacy and Safety of MNK-1411 in Duchenne Muscular Dystrophy (BRAVE)","Cosyntropin","Corticosteroid Secretion Stimulant","No",null,"No",null,"Phase 2",4,132,"Anticipated","2018-07-17","2020-08-01",{"$nulls":5},"This is a multicenter, double blind, placebo controlled, multiple dose study to examine the safety and efficacy of MNK-1411 in male subjects 4 to 8 years of age (inclusive) with Duchenne Muscular Dystrophy (DMD).",null,"A Multicenter, Randomized, Parallel Group, Double Blind, Multiple Dose, Placebo Controlled Study to Assess the Efficacy and Safety of MNK-1411 in Male Subjects 4 to 8 Years of Age With Duchenne Muscular Dystrophy","MNK14112096","Muscular Dystrophy, Duchenne","Muscular Dystrophy, Duchenne","Muscular Diseases","Musculoskeletal","Experimental|Placebo Comparator","Treatment A, MNK1411 High Dose|Treatment B, MNK1411 Low Dose|Treatment C, Placebo High Dose|Treatment D, Placebo Low Dose","Cosyntropin suspension 0.5/0.4 mL for up to 48 weeks|Cosyntropin suspension 0.25/0.2 mL for up to 48 weeks|Placebo suspension 0.4/0.5 mL for up to 24 weeks|Placebo suspension 0.25/0.2 mL for up to 24 weeks","Drug","Cosyntropin|Placebo","Suspension administered subcutaneously 2X week","MNK1411","Treatment A, MNK1411 High Dose|Treatment B, MNK1411 Low Dose|Treatment C, Placebo High Dose|Treatment D, Placebo Low Dose","\n\n 1. Subjects must have a documented diagnosis of Duchenne Muscular Dystrophy (DMD) confirmed by complete dystrophin deficiency (by immunofluorescence and/or immunoblot), or identifiable mutation in the DMD gene where reading frame can be predicated as \"out of frame,\" or complete dystrophin gene sequencing consistent with DMD; AND in the opinion of the Investigator, a typical clinical profile consistent with DMD.\n 2. Subjects taking approved treatments for DMD (by a Health Authority) that target dystrophin gene mutations (eg, eteplirsen or ataluren) may be enrolled in the study if they have been on a stable dose for 30 days prior to the first dose of study drug, and plan to remain on that dose throughout the study\n\n","\n\n 1. Subject has had previous systemic treatment with corticosteroids. Transient previous use of corticosteroids will be evaluated on a case-by-case basis by the sponsor or designee. Inhaled corticosteroids will be permitted if given at a stable dose for the 3 months prior to the first dose of study drug and the subject will remain on that dose throughout the study. The use of topical or intra-articular corticosteroids is permitted during the study.\n 2. Subject has symptomatic cardiomyopathy in the opinion of the investigator.\n 3. Subject is unable to complete the 10 meter Walk/Run test at the Screening and/or Baseline Visit.\n 4. Subject has Type 1 or Type 2 diabetes mellitus.\n 5. Subject has a history of chronic active hepatitis including acute or chronic hepatitis B, or acute or chronic hepatitis C.\n 6. Subject has a history of tuberculosis (TB) infection, any signs/symptoms of TB, or any close contact with an individual with an active TB infection.\n 7. Subject has known immune compromised status (not related to disease/condition under study), including but not limited to, individuals who have undergone organ transplantation or who are known to be positive for the human immunodeficiency virus.",{"$nulls":4},"Actual","2018-01-17","Actual","Anticipated","2020-08-01","Anticipated","2018-08-01","2018-01-09","2018-01-09","2018-08-01","Yes","Muscular Dystrophy\nDMD\nDuchenne","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","4 Years","8 Years","Male",null,"No",{"$nulls":4},"Yes","No",{"$nulls":19},"10 meter walk/run","Motor performance test","24 weeks","NorthStar Ambulatory Assessment|4 stair climb|Rise from supine test|Quantitative muscle testing","Motor performance battery|Motor performance test|Strength-knee flexion and extension measured in Newtons, using a dynamometer","24 weeks","clinicaltrials@mnk.com","Sean Ma","800-556-3314","Barcelona, Spain, 08041 Hospital Sant Joan De DeuBarcelona, Spain, 08950|Gulf Breeze, Florida, United States, 32561|Atlanta, Georgia, United States, 30318|Chicago, Illinois, United States, 60612|Las Vegas, Nevada, United States, 89145|San Antonio, Texas, United States, 78229|Norfolk, Virginia, United States, 23507|Wauwatosa, Wisconsin, United States, 53226","Florida|Georgia|Illinois|Nevada|Texas|Virginia|Wisconsin","Spain|United States","Hospital De La Santa Creu I Sant Pau|Nw Fl Clinical Research Group, Llc|Rare Disease Research, Llc|Rush University Medical Center|Las Vegas Clinic|The University Of Texas Health Science Center At San Antonio|Children's Specialty Group|Children's Hospital Of Wisconsin",{"$nulls":3},"Bryan Due","2018-08-01","2020-05-25T16:37:08.064","2020-05-26T17:10:42.972","NCT03400852"]
["5ecbf43411702c1b1b916a90","NCT03400852","2018-11-14","Mallinckrodt","MNK","Recruiting","A Study to Assess the Efficacy and Safety of MNK-1411 in Duchenne Muscular Dystrophy (BRAVE)","Cosyntropin","Corticosteroid Secretion Stimulant","No",null,"No",null,"Phase 2",4,132,"Anticipated","2018-07-17","2020-08-01",{"$nulls":5},"This is a multicenter, double blind, placebo controlled, multiple dose study to examine the safety and efficacy of MNK-1411 in male subjects 4 to 8 years of age (inclusive) with Duchenne Muscular Dystrophy (DMD).",null,"A Multicenter, Randomized, Parallel Group, Double Blind, Multiple Dose, Placebo Controlled Study to Assess the Efficacy and Safety of MNK-1411 in Male Participants 4 to 8 Years of Age With Duchenne Muscular Dystrophy","MNK14112096","Muscular Dystrophy, Duchenne","Muscular Dystrophy, Duchenne","Muscular Diseases","Musculoskeletal","Experimental|Placebo Comparator","Treatment A, MNK1411 High Dose|Treatment B, MNK1411 Low Dose|Treatment C, Placebo High Dose|Treatment D, Placebo Low Dose","Cosyntropin suspension 0.5/0.4 mL for up to 48 weeks|Cosyntropin suspension 0.25/0.2 mL for up to 48 weeks|Placebo suspension 0.4/0.5 mL for up to 24 weeks|Placebo suspension 0.25/0.2 mL for up to 24 weeks","Drug","Cosyntropin|Placebo","Suspension administered subcutaneously 2X week","MNK1411","Treatment A, MNK1411 High Dose|Treatment B, MNK1411 Low Dose|Treatment C, Placebo High Dose|Treatment D, Placebo Low Dose","\n\n 1. Participants must have a documented diagnosis of Duchenne Muscular Dystrophy (DMD) confirmed by complete dystrophin deficiency (by immunofluorescence and/or immunoblot), or identifiable mutation in the DMD gene where reading frame can be predicated as \"out of frame,\" or complete dystrophin gene sequencing consistent with DMD; AND in the opinion of the Investigator, a typical clinical profile consistent with DMD.\n 2. Participants taking approved treatments for DMD (by a Health Authority) that target dystrophin gene mutations (e.g., eteplirsen or ataluren) may be enrolled in the study if they have been on a stable dose for 30 days prior to the first dose of study drug, and plan to remain on that dose throughout the study.\n\n","\n\n 1. Participant has had previous systemic treatment with corticosteroids within 2 months prior to the Screening Visit. Exception: In subjects who were down-titrated to a physiological dose of corticosteroids (ie, 3mg/m2 of prednisone or deflazacort) a maximum of 1 month of no greater than a physiological dose followed by 1 month completely off corticosteroids prior to the Screening Visit will be acceptable for study entry. Transient previous use of corticosteroids will be evaluated on a case-by-case basis by the sponsor or designee. The use of topical or intra-articular corticosteroids is permitted during the study\n 2. Participant is unable to complete the 10 meter Walk/Run test at the Screening and/or Baseline Visit.\n 3. Participant has Type 1 or Type 2 diabetes mellitus.\n 4. Participant has a history of chronic active hepatitis including acute or chronic hepatitis B, or acute or chronic hepatitis C.\n 5. Participant has a history of tuberculosis (TB) infection, any signs/symptoms of TB, or any close contact with an individual with an active TB infection.\n 6. Participant has known immune compromised status (not related to disease/condition under study), including but not limited to, individuals who have undergone organ transplantation or who are known to be positive for the human immunodeficiency virus.",{"$nulls":4},"Actual","2018-01-17","Actual","Anticipated","2020-08-01","Anticipated","2018-11-01","2018-01-09","2018-01-09","2018-11-12","Yes","Muscular Dystrophy\nDMD\nDuchenne","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","4 Years","8 Years","Male",null,"No",{"$nulls":4},"Yes","No",{"$nulls":19},"10 meter walk/run","Motor performance test","24 weeks","NorthStar Ambulatory Assessment|4 stair climb|Rise from supine test|Quantitative muscle testing","Motor performance battery|Motor performance test|Strength-knee flexion and extension measured in Newtons, using a dynamometer","24 weeks","clinicaltrials@mnk.com","Study Manager","800-556-3314","Barcelona, Spain, 08041 Hospital Sant Joan De DeuBarcelona, Spain, 08950|Gulf Breeze, Florida, United States, 32561|Atlanta, Georgia, United States, 30318|Chicago, Illinois, United States, 60612|Las Vegas, Nevada, United States, 89145|New York, New York, United States, 10032|San Antonio, Texas, United States, 78229|Norfolk, Virginia, United States, 23507|Wauwatosa, Wisconsin, United States, 53226","Florida|Georgia|Illinois|Nevada|New York|Texas|Virginia|Wisconsin","Spain|United States","Hospital De La Santa Creu I Sant Pau|Nw Fl Clinical Research Group, Llc|Rare Disease Research, Llc|Rush University Medical Center|Las Vegas Clinic|Columbia University Medical Center|The University Of Texas Health Science Center At San Antonio|Children's Specialty Group|Children's Hospital Of Wisconsin",{"$nulls":3},"Jacqueline Delfgaauw","2018-11-12","2020-05-25T16:37:08.081","2020-05-26T17:10:42.972","NCT03400852"]
["5ecbf434307e3d1b1f8d9d11","NCT03400852","2018-12-05","Mallinckrodt","MNK","Recruiting","A Study to Assess the Efficacy and Safety of MNK-1411 in Duchenne Muscular Dystrophy (BRAVE)","Cosyntropin","Corticosteroid Secretion Stimulant","No",null,"No",null,"Phase 2",4,132,"Anticipated","2018-07-17","2020-08-01",{"$nulls":5},"This is a multicenter, double blind, placebo controlled, multiple dose study to examine the safety and efficacy of MNK-1411 in male subjects 4 to 8 years of age (inclusive) with Duchenne Muscular Dystrophy (DMD).",null,"A Multicenter, Randomized, Parallel Group, Double Blind, Multiple Dose, Placebo Controlled Study to Assess the Efficacy and Safety of MNK-1411 in Male Participants 4 to 8 Years of Age With Duchenne Muscular Dystrophy","MNK14112096","Muscular Dystrophy, Duchenne","Muscular Dystrophy, Duchenne","Muscular Diseases","Musculoskeletal","Experimental|Placebo Comparator","Treatment A, MNK1411 High Dose|Treatment B, MNK1411 Low Dose|Treatment C, Placebo High Dose|Treatment D, Placebo Low Dose","Cosyntropin suspension 0.5/0.4 mL for up to 48 weeks|Cosyntropin suspension 0.25/0.2 mL for up to 48 weeks|Placebo suspension 0.4/0.5 mL for up to 24 weeks|Placebo suspension 0.25/0.2 mL for up to 24 weeks","Drug","Cosyntropin|Placebo","Suspension administered subcutaneously 2X week","MNK1411","Treatment A, MNK1411 High Dose|Treatment B, MNK1411 Low Dose|Treatment C, Placebo High Dose|Treatment D, Placebo Low Dose","\n\n 1. Participants must have a documented diagnosis of Duchenne Muscular Dystrophy (DMD) confirmed by complete dystrophin deficiency (by immunofluorescence and/or immunoblot), or identifiable mutation in the DMD gene where reading frame can be predicated as \"out of frame,\" or complete dystrophin gene sequencing consistent with DMD; AND in the opinion of the Investigator, a typical clinical profile consistent with DMD.\n 2. Participants taking approved treatments for DMD (by a Health Authority) that target dystrophin gene mutations (e.g., eteplirsen or ataluren) may be enrolled in the study if they have been on a stable dose for 30 days prior to the first dose of study drug, and plan to remain on that dose throughout the study.\n\n","\n\n 1. Participant has had previous systemic treatment with corticosteroids within 2 months prior to the Screening Visit. Exception: In subjects who were down-titrated to a physiological dose of corticosteroids (ie, 3mg/m2 of prednisone or deflazacort) a maximum of 1 month of no greater than a physiological dose followed by 1 month completely off corticosteroids prior to the Screening Visit will be acceptable for study entry. Transient previous use of corticosteroids will be evaluated on a case-by-case basis by the sponsor or designee. The use of topical or intra-articular corticosteroids is permitted during the study\n 2. Participant is unable to complete the 10 meter Walk/Run test at the Screening and/or Baseline Visit.\n 3. Participant has Type 1 or Type 2 diabetes mellitus.\n 4. Participant has a history of chronic active hepatitis including acute or chronic hepatitis B, or acute or chronic hepatitis C.\n 5. Participant has a history of tuberculosis (TB) infection, any signs/symptoms of TB, or any close contact with an individual with an active TB infection.\n 6. Participant has known immune compromised status (not related to disease/condition under study), including but not limited to, individuals who have undergone organ transplantation or who are known to be positive for the human immunodeficiency virus.",{"$nulls":4},"Actual","2018-01-17","Actual","Anticipated","2020-08-01","Anticipated","2018-12-01","2018-01-09","2018-01-09","2018-12-04","Yes","Muscular Dystrophy\nDMD\nDuchenne","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","4 Years","8 Years","Male",null,"No",{"$nulls":4},"Yes","No",{"$nulls":19},"10 meter walk/run","Motor performance test","24 weeks","NorthStar Ambulatory Assessment|4 stair climb|Rise from supine test|Quantitative muscle testing","Motor performance battery|Motor performance test|Strength-knee flexion and extension measured in Newtons, using a dynamometer","24 weeks","clinicaltrials@mnk.com","Study Manager","800-556-3314","Barcelona, Spain, 08025 Hospital Sant Joan De DeuBarcelona, Spain, 08950|Gulf Breeze, Florida, United States, 32561|Atlanta, Georgia, United States, 30318|Chicago, Illinois, United States, 60612|Las Vegas, Nevada, United States, 89145|New York, New York, United States, 10032|San Antonio, Texas, United States, 78229|Norfolk, Virginia, United States, 23507|Wauwatosa, Wisconsin, United States, 53226","Florida|Georgia|Illinois|Nevada|New York|Texas|Virginia|Wisconsin","Spain|United States","Hospital De La Santa Creu I Sant Pau|Nw Fl Clinical Research Group, Llc|Rare Disease Research, Llc|Rush University Medical Center|Las Vegas Clinic|Columbia University Medical Center|The University Of Texas Health Science Center At San Antonio|Children's Specialty Group|Children's Hospital Of Wisconsin",{"$nulls":3},"Jacqueline Delfgaauw","2018-12-04","2020-05-25T16:37:08.444","2020-05-26T17:10:42.972","NCT03400852"]
["5ecbf434feab101b155308b2","NCT03400852","2019-03-06","Mallinckrodt","MNK","Recruiting","A Study to Assess the Efficacy and Safety of MNK-1411 in Duchenne Muscular Dystrophy (BRAVE)","Cosyntropin","Corticosteroid Secretion Stimulant","No",null,"No",null,"Phase 2",4,132,"Anticipated","2018-07-17","2020-07-01",{"$nulls":5},"This is a multicenter, double blind, placebo controlled, multiple dose study to examine the safety and efficacy of MNK-1411 in male subjects 4 to 8 years of age (inclusive) with Duchenne Muscular Dystrophy (DMD).",null,"A Multicenter, Randomized, Parallel Group, Double Blind, Multiple Dose, Placebo Controlled Study to Assess the Efficacy and Safety of MNK-1411 in Male Participants 4 to 8 Years of Age With Duchenne Muscular Dystrophy","MNK14112096","Muscular Dystrophy, Duchenne","Muscular Dystrophy, Duchenne","Muscular Diseases","Musculoskeletal","Experimental|Placebo Comparator","Treatment A, MNK1411 High Dose|Treatment B, MNK1411 Low Dose|Treatment C, Placebo High Dose|Treatment D, Placebo Low Dose","Cosyntropin suspension 0.5/0.4 mL for up to 48 weeks|Cosyntropin suspension 0.25/0.2 mL for up to 48 weeks|Placebo suspension 0.4/0.5 mL for up to 24 weeks|Placebo suspension 0.25/0.2 mL for up to 24 weeks","Drug","Cosyntropin|Placebo","Suspension administered subcutaneously 2X week","MNK1411","Treatment A, MNK1411 High Dose|Treatment B, MNK1411 Low Dose|Treatment C, Placebo High Dose|Treatment D, Placebo Low Dose","\n\n 1. Participants must have a documented diagnosis of Duchenne Muscular Dystrophy (DMD) confirmed by complete dystrophin deficiency (by immunofluorescence and/or immunoblot), or identifiable mutation in the DMD gene where reading frame can be predicated as \"out of frame,\" or complete dystrophin gene sequencing consistent with DMD; AND in the opinion of the Investigator, a typical clinical profile consistent with DMD.\n 2. Participants taking approved treatments for DMD (by a Health Authority) that target dystrophin gene mutations (e.g., eteplirsen or ataluren) may be enrolled in the study if they have been on a stable dose for 30 days prior to the first dose of study drug, and plan to remain on that dose throughout the study.\n\n","\n\n 1. Participant has had previous systemic treatment with corticosteroids within 2 months prior to the Screening Visit. Exception: In subjects who were down-titrated to a physiological dose of corticosteroids (ie, 3mg/m2 of prednisone or deflazacort) a maximum of 1 month of no greater than a physiological dose followed by 1 month completely off corticosteroids prior to the Screening Visit will be acceptable for study entry. Transient previous use of corticosteroids will be evaluated on a case-by-case basis by the sponsor or designee. The use of topical or intra-articular corticosteroids is permitted during the study\n 2. Participant is unable to complete the 10 meter Walk/Run test at the Screening and/or Baseline Visit.\n 3. Participant has Type 1 or Type 2 diabetes mellitus.\n 4. Participant has a history of chronic active hepatitis including acute or chronic hepatitis B, or acute or chronic hepatitis C.\n 5. Participant has a history of tuberculosis (TB) infection, any signs/symptoms of TB, or any close contact with an individual with an active TB infection.\n 6. Participant has known immune compromised status (not related to disease/condition under study), including but not limited to, individuals who have undergone organ transplantation or who are known to be positive for the human immunodeficiency virus.",{"$nulls":4},"Actual","2018-01-17","Actual","Anticipated","2020-08-01","Anticipated","2019-01-01","2018-01-09","2018-01-09","2019-03-05","Yes","Muscular Dystrophy\nDMD\nDuchenne","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","4 Years","8 Years","Male",null,"No",{"$nulls":4},"Yes","No",{"$nulls":19},"10 meter walk/run","Motor performance test","24 weeks","NorthStar Ambulatory Assessment|4 stair climb|Rise from supine test|Quantitative muscle testing","Motor performance battery|Motor performance test|Strength-knee flexion and extension measured in Newtons, using a dynamometer","24 weeks","clinicaltrials@mnk.com","Study Manager","800-556-3314","[Active, Not Recruiting]HÌ±Olon, Israel, 5810001|Celaya, Guanajuanto, Mexico, 38020|Durango, Mexico, 34000 Grupo Medico Camino, Mexico City, Mexico, 03310|Guadalajara, Jalisco, Mexico, 44280|CuliacÃ¡n, Sinaloa, Mexico, 80020|Donostia, Gipuzkoa, Spain, 20014|Barcelona, Spain, 08025 Hospital Sant Joan De DeuBarcelona, Spain, 08950 Hospital Universitari I Politecnic La Fe ValenciaValencia, Spain, 46026|[Active, Not Recruiting]EskiÅŸehir, Turkey, 26480 Mersin Universitesi Tip Fakultesi HastanesiMersin, Turkey, 33343|[Active, Not Recruiting]Los Angeles, California, United States, 90027|Gulf Breeze, Florida, United States, 32561|Atlanta, Georgia, United States, 30318|Chicago, Illinois, United States, 60612|Las Vegas, Nevada, United States, 89145|New York, New York, United States, 10032|San Antonio, Texas, United States, 78229|Norfolk, Virginia, United States, 23507|Wauwatosa, Wisconsin, United States, 53226","California|Florida|Georgia|Illinois|Nevada|New York|Texas|Virginia|Wisconsin","Israel|Mexico|Spain|Turkey|United States","Edith Wolfson Medical Center|Guanajuanto Hospital San Jose De Celaya|Instituto De Investigaciones Aplicadas A La Neurociencia A.C.|Jalisco Hospital Civil Fray Antonio Alcalde|Sinaloa Neurociencias Estudios Clinicos S.C.|Gipuzkoa Hospital Universitario De Donostia|Hospital De La Santa Creu I Sant Pau|Eskisehir Osmangazi Universitesi Tip Fakultesi Hastanesi|Children's Hospital Los Angeles|Nw Fl Clinical Research Group, Llc|Rare Disease Research, Llc|Rush University Medical Center|Las Vegas Clinic|Columbia University Medical Center|The University Of Texas Health Science Center At San Antonio|Children's Specialty Group|Children's Hospital Of Wisconsin",{"$nulls":3},"Study Director","2019-03-05","2020-05-25T16:37:08.760","2020-05-26T17:10:42.972","NCT03400852"]
["5ecbf43411702c1b1b916a91","NCT03400852","2020-01-21","Mallinckrodt","MNK","Active, not recruiting","A Study to Assess the Efficacy and Safety of MNK-1411 in Duchenne Muscular Dystrophy (BRAVE)","Cosyntropin","Corticosteroid Secretion Stimulant","No",null,"No",null,"Phase 2",4,44,"Actual","2018-07-17","2020-02-01",{"$nulls":5},"This is a multicenter, double blind, placebo controlled, multiple dose study to examine the safety and efficacy of MNK-1411 in male subjects 4 to 8 years of age (inclusive) with Duchenne Muscular Dystrophy (DMD).",null,"A Multicenter, Randomized, Parallel Group, Double Blind, Multiple Dose, Placebo Controlled Study to Assess the Efficacy and Safety of MNK-1411 in Male Participants 4 to 8 Years of Age With Duchenne Muscular Dystrophy","MNK14112096","Muscular Dystrophy, Duchenne","Muscular Dystrophy, Duchenne","Muscular Diseases","Musculoskeletal","Experimental|Placebo Comparator","Treatment A, MNK1411 High Dose|Treatment B, MNK1411 Low Dose|Treatment C, Placebo High Dose|Treatment D, Placebo Low Dose","Cosyntropin suspension 0.5/0.4 mL for up to 48 weeks|Cosyntropin suspension 0.25/0.2 mL for up to 48 weeks|Placebo suspension 0.4/0.5 mL for up to 24 weeks|Placebo suspension 0.25/0.2 mL for up to 24 weeks","Drug","Cosyntropin|Placebo","Suspension administered subcutaneously twice weekly","MNK1411|Matching Placebo","Treatment A, MNK1411 High Dose|Treatment B, MNK1411 Low Dose|Treatment C, Placebo High Dose|Treatment D, Placebo Low Dose","\n\n 1. Participants must have a documented diagnosis of Duchenne Muscular Dystrophy (DMD) confirmed by complete dystrophin deficiency (by immunofluorescence and/or immunoblot), or identifiable mutation in the DMD gene where reading frame can be predicated as \"out of frame,\" or complete dystrophin gene sequencing consistent with DMD; AND in the opinion of the Investigator, a typical clinical profile consistent with DMD.\n 2. Participants taking approved treatments for DMD (by a Health Authority) that target dystrophin gene mutations (e.g., eteplirsen or ataluren) may be enrolled in the study if they have been on a stable dose for 30 days prior to the first dose of study drug, and plan to remain on that dose throughout the study.\n\n","\n\n 1. Participant has had previous systemic treatment with corticosteroids within 2 months prior to the Screening Visit. Exception: In subjects who were down-titrated to a physiological dose of corticosteroids (ie, 3mg/m2 of prednisone or deflazacort) a maximum of 1 month of no greater than a physiological dose followed by 1 month completely off corticosteroids prior to the Screening Visit will be acceptable for study entry. Transient previous use of corticosteroids will be evaluated on a case-by-case basis by the sponsor or designee. The use of topical or intra-articular corticosteroids is permitted during the study\n 2. Participant is unable to complete the 10 meter Walk/Run test at the Screening and/or Baseline Visit.\n 3. Participant has Type 1 or Type 2 diabetes mellitus.\n 4. Participant has a history of chronic active hepatitis including acute or chronic hepatitis B, or acute or chronic hepatitis C.\n 5. Participant has a history of tuberculosis (TB) infection, any signs/symptoms of TB, or any close contact with an individual with an active TB infection.\n 6. Participant has known immune compromised status (not related to disease/condition under study), including but not limited to, individuals who have undergone organ transplantation or who are known to be positive for the human immunodeficiency virus.",{"$nulls":4},"Actual","2018-01-17","Actual","Anticipated","2020-02-01","Anticipated","2020-01-01","2018-01-09","2018-01-09","2020-01-16","Yes","Muscular Dystrophy\nDMD\nDuchenne","Interventional","Treatment","Parallel Assignment","Double (Participant, Investigator)","Randomized","4 Years","8 Years","Male",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":17},"2017-004139-35","EudraCT Number","10 meter walk/run","Motor performance test","24 weeks","NorthStar Ambulatory Assessment|4 stair climb|Rise from supine test|Quantitative muscle testing","Motor performance battery|Motor performance test|Strength-knee flexion and extension measured in Newtons, using a dynamometer","24 weeks",{"$nulls":3},"Sofia, Bulgaria, 1431|HÌ±Olon, Israel, 5810001|Milano, Lombardia, Italy, 20132|Durango, Mexico, 34000|Guadalajara, Jalisco, Mexico, 44280|CuliacÃ¡n, Sinaloa, Mexico, 80020|Belgrade, Serbia, 11000|Barcelona, Spain, 08025 Hospital Sant Joan De Deu - PinEsplugues De Llobregat, Spain, 08950 Hospital Universitari I Politecnic La Fe ValenciaValencia, Spain, 46026|Mersin, Turkey, 33343|Gulf Breeze, Florida, United States, 32561|Atlanta, Georgia, United States, 30318|Nashville, Tennessee, United States, 37232|Dallas, Texas, United States, 75207 Ut Health Science Center, San AntonioSan Antonio, Texas, United States, 78229","Florida|Georgia|Tennessee|Texas","Bulgaria|Israel|Italy|Mexico|Serbia|Spain|Turkey|United States","University Multiprofile Hospital For Active Treatment Aleksandrovska Ead|Edith Wolfson Medical Center|Lombardia Ospedale San Raffaele S.R.L. - Ppds|Instituto De Investigaciones Aplicadas A La Neurociencia A.C.|Jalisco Hospital Civil Fray Antonio Alcalde|Sinaloa Neurociencias Estudios Clinicos S.C.|Clinic Of Neurology And Psychiatry For Children And Youth|Hospital De La Santa Creu I Sant Pau|Mersin Universitesi Tip Fakultesi Hastanesi|Nw Fl Clinical Research Group, Llc|Rare Disease Research, Llc|Monroe Carell Jr Childrens Hospital At Vanderbilt|University Of Texas Southwestern Medical Center",{"$nulls":3},"Clinical Study Lead","2020-01-16","2020-05-25T16:37:08.802","2020-05-26T17:10:42.972","NCT03400852"]
["5ecbf435e2561b1b11905d7f","NCT03400943","2018-01-17","Bayer","BAYN","Not yet recruiting","Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 3)","Bay-1002670|Vilaprisan","PR Modulator","Yes","['Bay-1002670', 'Vilaprisan']","No",null,"Phase 3",4,260,"Anticipated","2018-02-20","2020-05-20",{"$nulls":5},"The primary objective of this study is to show superiority in the treatment of HMB of vilaprisan in subjects with uterine fibroids compared to placebo.\n\nThe secondary objectives of this study are to additionally evaluate the efficacy and safety of vilaprisan in subjects with uterine fibroids.",null,"A Randomized, Parallel-group, Double-blind and Open-label Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Vilaprisan in Subjects With Uterine Fibroids",15787,"Leiomyoma","Leiomyoma|Myoma","Oncology Solid Tumor","Oncology","Experimental","Vilaprisan_A1|Vilaprisan_A2|Vilaprisan_B1|Vilaprisan_B2","vilaprisan (2 mg), 2 treatment periods of 12 weeks, separated by 1 bleeding episode|vilaprisan (2 mg), 2 treatment periods of 12 weeks without a break|placebo, 1 treatment period of 12 weeks, and vilaprisan (2 mg), 1 treatment period of 12 weeks, separated by 1 bleeding episode|vilaprisan (2 mg), 1 treatment period of 12 weeks, and placebo, 1 treatment period of 12 weeks, separated by 1 bleeding episode","Drug","Vilaprisan (BAY1002670)|Placebo","2 mg of Vilaprisan once daily up to 2 x 12 weeks|Matching placebo is administered to group B1 and B2.",null,"Vilaprisan_A1|Vilaprisan_A2|Vilaprisan_B1|Vilaprisan_B2","\n\n * Women, 18 years or older in good General health\n * Diagnosis of uterine fibroid(s) documented by ultrasound at screening with at least 1 fibroid with largest Diameter â‰¥ 30 mm and < 120 mm\n * Heavy menstrual bleeding (HMB) in at least 2 bleeding periods during the Screening period each with blood loss volume of >80.00 mL documented by alkaline hematin (AH) method\n * An endometrial biopsy performed during the Screening period without significant histological disorder such as endometrial hyperplasia (including simple hyperplasia) or other significant endometrial pathology\n * Use of an acceptable non-hormonal method of contraception (ie, either male condom, cap, diaphragm or sponge, each in combination with spermicide) starting at Visit 1 until the end of the study\n\n","\n\n * Pregnancy or lactation (less than 3 month since delivery, abortion, or lactation before start of Treatment)\n * Hypersensitivity to any ingredient of the study drug\n * Any condition requiring immediate blood transfusion\n * Laboratory values outside inclusion range before randomization and considered as clinically relevant.\n * Any diseases, conditions, or medications that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study drug\n * Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results\n * Abuse of alcohol, drugs, or medicines (eg, laxatives)\n * Use of other treatments that might interfere with the conduct of the study or the interpretation of the results\n * Undiagnosed abnormal genital bleeding",{"$nulls":4},"Actual","2018-01-17","Actual","Anticipated","2020-05-20","Anticipated","2018-01-01","2018-01-05","2018-01-15","2018-01-15","No","Uterine fibroids\nHeavy menstrual bleeding","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"Female",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"2017-002997-38","EudraCT Number","Amenorrhea (yes/no)","Amenorrhea (yes/no), defined as MBL <2 mL during the last 28 days of treatment.","The last 28 days of treatment period 1 and treatment period 2","Time to onset of amenorrhea|Time to onset of controlled bleeding|Heavy Menstrual Bleeding (HMB) response|Endometrial histology|Endometrial thickness|Absence of bleeding (spotting allowed)","Onset of amenorrhea is defined by the first day for which the menstrual blood loss for all subsequent 28-day periods up to the end of the treatment period is <2 mL|Onset of controlled bleeding is defined by the first day, for which the menstrual blood loss for all subsequent 28-day periods up to the end of the treatment period is <80.00 mL|HMB response defined as blood loss <80.00 mL during the last 28 days of treatment and >50% reduction compared to baseline|Benign endometrium, presence or absence of hyperplasia or malignancy|Up to 36 weeks|By Uterine Fibroid Daily Bleeding Diary (UF-DBD)","In treatment period 1 (12 weeks) and in treatment period 2 (12 weeks)|The last 28 days of treatment period 1 and treatment period 2|Up to 36 weeks","clinical-trials-contact@bayer.com","Bayer Clinical Trials Contact","(+) 1-888-8422937","Gabrovo, Bulgaria, 5300 Hospital For Active Treatment - Prof.Paraskev Stoyanov AdLovech, Bulgaria, 5500 Mhat Dr. Bratan Shukerov AdSmolyan, Bulgaria, 4700 Mhat For Women'S Health - Nadezhda OodSofia, Bulgaria, 1330|Beijing, China, 100010 Peking University First HospitalBeijing, China, 100034 Beijing Shijitan Hospital, Capital Medical UniversityBeijing, China, 100038 Beijing Tiantan Hospital, Captial Medical UniversityBeijing, China, 100050 International Peace Maternity&Child Health Hospital Of CwiShanghai, China, 200030 Shanghai First Maternity And Infant HospitalShanghai, China, 200040 Shanghai General HospitalShanghai, China, 200080 Shanghai East Hospital Affiated To Tongji UniversityShanghai, China, 200123 Tianjin Medical University General HospitalTianjin, China, 300052 First Teaching Hosptial Of Tianjin University Of TcmTianjin, China, 300193 Tianjin Central Hospital Of Gynecology ObstetricsTianjin, China, 300199|Fuzhou, Fujian, China, 350025|Guangzhou, Guangdong, China, 510630|Haikou, Hainan, China, 570311|Wuhan, Hubei, China, 430013|Nanjing, Jiangsu, China, 210004 Nj Drum Tower Hospital, The Affil Hos Of Nj Univ Med SchoolNanjing, Jiangsu, China, 210008 1St Affiliated Hospital Of Soochow UniversitySuzhou, Jiangsu, China, 215006|Nanchang, Jiangxi, China, 330006 The Second Affiliated Hospital Of Nanchang UniversityNanchang, Jiangxi, China, 330006|Changchun, Jilin, China, 130021|Dalian, Liaoning, China, 116011 Shengjing Hospital Of|Shenyang, Liaoning, China, 110004|Yinchuan, Ningxia, China, 750004|Chengdu, Sichuan, China, 610041|Xi'An, Shaanxi, China, 710061|Xi'An, Shaanxi, China, 710004|Taiyuan, Shanxi, China, 030001|Urumqi, Xinjiang, China, 830054|Hangzhou, Zhejiang, China, 310006 Sir Run Run Shaw Hospital, Zhejiang Univ. School Of MedicineHangzhou, Zhejiang, China, 310016 The Second Affliated Hospital Of Wenzhou Medicial UniversityWenzhou, Zhejiang, China, 325000|Brno, Czechia, 602 00 Soukroma Gynekologicka AmbulanceFulnek, Czechia, 74245 Gynekologie Studentsky Dum S.R.O.Praha 6, Czechia, 160 00 Mudr. Ivana Salamonova S.R.O.Vysoke Myto, Czechia, 566 01|Atlanta, Georgia, United States, 30312 Agile Clinical Research Trials, LlcAtlanta, Georgia, United States, 30328 Atlanta Women'S Research Institute, Inc.Atlanta, Georgia, United States, 30342 Medisense, Inc.Atlanta, Georgia, United States, 30363 Atlanta Gynecology Research Institute, Inc.Suwanee, Georgia, United States, 30024|Afula, Israel, 1834111 Soroka University Medical CenterBe'Er Sheva, Israel, 8410101 Hillel Yaffe Medical CenterHadera, Israel, 3810101 Rambam Health CorporationHaifa, Israel, 3109601 Lady Davis Carmel Medical CenterHaifa, Israel, 3436212 Meir Medical CenterKfar Saba, Israel, 4428164 Health Corporation Of Galilee Medical CenterNahariya, Israel, 2210001|Hawkes Bay, New Zealand, 4130 P3 ResearchTauranga, New Zealand, 3110|Johannesburg, Gauteng, South Africa, 2193 Dr L Reynders PracticeLyttelton Manor, Gauteng, South Africa, 0141 Wilgeheuwel HospitalRoodepoort, Gauteng, South Africa, 1724|Durban, Kwazulu-Natal, South Africa, 4319 Ethekwini Hospital & Heart CentreDurban, Kwazulu-Natal, South Africa|Birmingham, Alabama, United States, 35294-0026 Coastal Clinical Research, IncMobile, Alabama, United States, 36608|Chandler, Arizona, United States, 85224|Arcadia, California, United States, 91007 Sutter East Bay Medical CenterBerkeley, California, United States, 94704 Core Healthcare GroupCerritos, California, United States, 90703 Aviva ResearchEscondido, California, United States, 92025 National Research InstituteLos Angeles, California, United States, 90057|Newark, Delaware, United States, 10713|Aventura, Florida, United States, 33180 Helix Biomedics, LlcBoynton Beach, Florida, United States, 33436 Dr. Victoria Garcia & Associates, Llc Doral Medical ResearchDoral, Florida, United States, 33166 The Clinical Research InstituteHialeah, Florida, United States, 33012 Clinical Neurosciences Solutions, Inc. Dba Cns HealthcareJacksonville, Florida, United States, 322256 Axcess Medical Research, LlcLoxahatchee Groves, Florida, United States, 33470 Sweet Hope Research Specialty IncMiami Lakes, Florida, United States, 33016 Serenity Holistic ObgynNorth Miami Beach, Florida, United States, 33162 Compass Research, LlcOrlando, Florida, United States, 32806 Discovery Clinical ResearchPlantation, Florida, United States, 33324 Oncova Clinical Research, Inc.Saint Cloud, Florida, United States, 34769 Univ.Of South Florida College Of MedicineTampa, Florida, United States, 33606|Naperville, Illinois, United States, 60542|Indianapolis, Indiana, United States, 46202|Shawnee Mission, Kansas, United States, 66218|Louisville, Kentucky, United States, 40202|Shreveport, Louisiana, United States, 71118|Gaithersburg, Maryland, United States, 20878 Maryland Physicians EdgeSilver Spring, Maryland, United States, 20910|Brooklyn, New York, United States, 11203 University Of Rochester Medical CenterRochester, New York, United States, 14623|Charlotte, North Carolina, United States, 28204 Unified Women'S Clinical Research - Morehead CityMorehead City, North Carolina, United States, 28557 Eastern Carolina Women'S CenterNew Bern, North Carolina, United States, 28562 Wake Forest Baptist HealthWinston-Salem, North Carolina, United States, 27103|Oklahoma City, Oklahoma, United States, 73104|Bryn Mawr, Pennsylvania, United States, 19010 Clinical Research Of Philadelphia, LlcPhiladelphia, Pennsylvania, United States, 19114|West Columbia, South Carolina, United States, 29169|Chattanooga, Tennessee, United States, 37404 Clinical Neurosciences Solutions, Inc Dba Cns HealthcareMemphis, Tennessee, United States, 38119|Fort Worth, Texas, United States, 76104 Family Medicine ClinicGeorgetown, Texas, United States, 78626 The Center For Clinical Trials, Inc.Houston, Texas, United States, 77082 Biopharma Informatic, Inc.Houston, Texas, United States, 77084 Houston Center For Clinical Research, LlcSugar Land, Texas, United States, 77479|Salt Lake City, Utah, United States, 84107|Arlington, Virginia, United States, 22207 Inova Fairfax HospitalFalls Church, Virginia, United States, 22042 Alliance Women'S HealthRichmond, Virginia, United States, 23226|Covington, Washington, United States, 98042 Dedicated Women'S Health Specialists, Inc.Puyallup, Washington, United States, 98372","Alabama|Arizona|California|Delaware|Florida|Illinois|Indiana|Kansas|Kentucky|Louisiana|Maryland|New York|North Carolina|Oklahoma|Pennsylvania|South Carolina|Tennessee|Texas|Utah|Virginia|Washington","Bulgaria|China|Czechia|Georgia|Israel|New Zealand|South Africa|United States","Multiprofile Hospital For Active Treatment-Dr. T. Venkova Ad|Beijing Hospital Of Traditional Chinese Medicine|Fujian Fuzhou General Hospital Of Nanjing Military Command|Guangdong The Third Affiliated Hospital, Sun Yat-Sen University|Hainan Hainan General Hospital|Hubei Center For Reproductive Medicine,Tongji Medical College,Hust|Jiangsu Nanjing Maternity And Child Health Care Hospital|Jiangxi Jiangxi Maternal And Child Health Hospital|Jilin The First Hospital Of Jilin University|Liaoning The First Affiliated Hospital Of Dalian Medical University|Medical University|Ningxia General Hospital Of Ningxia Medical University|Second University Hospital|Shaanxi 1St Affiliated Hospital Of Xi'An Jiaotong Medical University|Shaanxi Second Affiliated Hospital Xian Jiaotong University School|Shanxi The Second Affiliated Hospital Of Shanxi Medical University|Xinjiang The First Affiliated Hospital Of Xinjiang Medical University|Zhejiang Women's Hospital School Of Medicine Zhejiang University|Gynekologie Meda S.R.O.|Center For Women|Haemek Medical Center|P3 Research Ltd Hawkes Bay|, Gauteng Wits Clinical Research Site|, Kwazulu-Natal Umhlanga Medical Centre|University Of Alabama At Birmingham|New Horizons Women's Care|Retina Institute Of California|Christiana Care Health System|South Florida Medical Research|Advocate Lutheran|Indiana University|Gtc Research|University Of Louisville|Omni Fertility And Laser Institute|Simmonds, Martin And Helmbrecht|Suny Downstate Medical Center|Carolinas Healthcare System|Oklahoma University|Main Line Fertility Center|Invocare Clinical Research Center, Llc|Chattanooga Medical Research, Llc|Texas Health Care, Pllc|Wasatch Clinical Research, Llc|Clinical Research Network|Multicare Health Systems Women's Health Care",{"$nulls":3},"Bayer Study Director","2018-01-15","2020-05-25T16:37:09.904","2020-05-26T17:10:42.972","NCT03400943"]
["5ecbf43511702c1b1b916a94","NCT03400943","2018-04-24","Bayer","BAYN","Recruiting","Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 3)","Bay-1002670|Vilaprisan","PR Modulator","Yes","['Bay-1002670', 'Vilaprisan']","No",null,"Phase 3",4,260,"Anticipated","2018-01-17","2020-05-20",{"$nulls":5},"The primary objective of this study is to show superiority in the treatment of HMB of vilaprisan in subjects with uterine fibroids compared to placebo.\n\nThe secondary objectives of this study are to additionally evaluate the efficacy and safety of vilaprisan in subjects with uterine fibroids.",null,"A Randomized, Parallel-group, Double-blind and Open-label Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Vilaprisan in Subjects With Uterine Fibroids",15787,"Leiomyoma","Leiomyoma|Myoma","Oncology Solid Tumor","Oncology","Experimental","Vilaprisan_A1|Vilaprisan_A2|Vilaprisan_B1|Vilaprisan_B2","vilaprisan (2 mg), 2 treatment periods of 12 weeks, separated by 1 bleeding episode|vilaprisan (2 mg), 2 treatment periods of 12 weeks without a break|placebo, 1 treatment period of 12 weeks, and vilaprisan (2 mg), 1 treatment period of 12 weeks, separated by 1 bleeding episode|vilaprisan (2 mg), 1 treatment period of 12 weeks, and placebo, 1 treatment period of 12 weeks, separated by 1 bleeding episode","Drug","Vilaprisan (BAY1002670)|Placebo","2 mg of Vilaprisan once daily up to 2 x 12 weeks|Matching placebo is administered to group B1 and B2.",null,"Vilaprisan_A1|Vilaprisan_A2|Vilaprisan_B1|Vilaprisan_B2","\n\n * Women, 18 years or older in good General health\n * Diagnosis of uterine fibroid(s) documented by ultrasound at screening with at least 1 fibroid with largest Diameter â‰¥ 30 mm and < 120 mm\n * Heavy menstrual bleeding (HMB) in at least 2 bleeding periods during the Screening period each with blood loss volume of >80.00 mL documented by alkaline hematin (AH) method\n * An endometrial biopsy performed during the Screening period without significant histological disorder such as endometrial hyperplasia (including simple hyperplasia) or other significant endometrial pathology\n * Use of an acceptable non-hormonal method of contraception (ie, either male condom, cap, diaphragm or sponge, each in combination with spermicide) starting at Visit 1 until the end of the study\n\n","\n\n * Pregnancy or lactation (less than 3 month since delivery, abortion, or lactation before start of Treatment)\n * Hypersensitivity to any ingredient of the study drug\n * Any condition requiring immediate blood transfusion\n * Laboratory values outside inclusion range before randomization and considered as clinically relevant.\n * Any diseases, conditions, or medications that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study drug\n * Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results\n * Abuse of alcohol, drugs, or medicines (eg, laxatives)\n * Use of other treatments that might interfere with the conduct of the study or the interpretation of the results\n * Undiagnosed abnormal genital bleeding",{"$nulls":4},"Actual","2018-01-17","Actual","Anticipated","2020-05-20","Anticipated","2018-04-01","2018-01-05","2018-01-15","2018-04-23","No","Uterine fibroids\nHeavy menstrual bleeding","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"Female",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"2017-002997-38","EudraCT Number","Amenorrhea (yes/no)","Amenorrhea (yes/no), defined as MBL <2 mL during the last 28 days of treatment.","The last 28 days of treatment period 1 and treatment period 2","Time to onset of amenorrhea|Time to onset of controlled bleeding|Heavy Menstrual Bleeding (HMB) response|Endometrial histology|Endometrial thickness|Absence of bleeding (spotting allowed)","Onset of amenorrhea is defined by the first day for which the menstrual blood loss for all subsequent 28-day periods up to the end of the treatment period is <2 mL|Onset of controlled bleeding is defined by the first day, for which the menstrual blood loss for all subsequent 28-day periods up to the end of the treatment period is <80.00 mL|HMB response defined as blood loss <80.00 mL during the last 28 days of treatment and >50% reduction compared to baseline|Benign endometrium, presence or absence of hyperplasia or malignancy|Up to 36 weeks|By Uterine Fibroid Daily Bleeding Diary (UF-DBD)","In treatment period 1 (12 weeks) and in treatment period 2 (12 weeks)|The last 28 days of treatment period 1 and treatment period 2|Up to 36 weeks","clinical-trials-contact@bayer.com","Bayer Clinical Trials Contact","(+) 1-888-8422937","Gabrovo, Bulgaria, 5300 Hospital For Active Treatment - Prof.Paraskev Stoyanov AdLovech, Bulgaria, 5500 Mhat Dr. Bratan Shukerov AdSmolyan, Bulgaria, 4700 Mhat For Women'S Health - Nadezhda OodSofia, Bulgaria, 1330|Beijing, China, 100010 Peking University First HospitalBeijing, China, 100034 Beijing Friendship Hospital, Capital Medical UniversityBeijing, China, 100050 Beijing Tiantan Hospital, Captial Medical UniversityBeijing, China, 100050 International Peace Maternity&Child Health Hospital Of CwiShanghai, China, 200030 Shanghai First Maternity And Infant HospitalShanghai, China, 200040 Shanghai General HospitalShanghai, China, 200080 Shanghai East Hospital Affiated To Tongji UniversityShanghai, China, 200123 Tianjin Medical University General HospitalTianjin, China, 300052 First Teaching Hosptial Of Tianjin University Of TcmTianjin, China, 300193 Tianjin Central Hospital Of Gynecology ObstetricsTianjin, China, 300199|Fuzhou, Fujian, China, 350025|Guangzhou, Guangdong, China, 510623 The Third Affiliated Hospital, Sun Yat-Sen UniversityGuangzhou, Guangdong, China, 510630 Boai Hospital Of ZhongshanZhongshan, Guangdong, China|Haikou, Hainan, China, 570311|Wuhan, Hubei, China, 430013|Nanjing, Jiangsu, China, 210004 Nanjing First HospitalNanjing, Jiangsu, China, 210006 Nj Drum Tower Hospital, The Affil Hos Of Nj Univ Med SchoolNanjing, Jiangsu, China, 210008 Zhongda Hospital Southeast UniversityNanjing, Jiangsu, China, 210009 1St Affiliated Hospital Of Soochow UniversitySuzhou, Jiangsu, China, 215006|Nanchang, Jiangxi, China, 330006 The Second Affiliated Hospital Of Nanchang UniversityNanchang, Jiangxi, China, 330006|Changchun, Jilin, China, 130021|Dalian, Liaoning, China, 116011 Shengjing Hospital Of|Shenyang, Liaoning, China, 110004|Yinchuan, Ningxia, China, 750004|Chengdu, Sichuan, China, 610041|Xi'An, Shaanxi, China, 710061|Xi'An, Shaanxi, China, 710004|Taiyuan, Shanxi, China, 030001|Urumqi, Xinjiang, China, 830054|Hangzhou, Zhejiang, China, 310006 Sir Run Run Shaw Hospital, Zhejiang Univ. School Of MedicineHangzhou, Zhejiang, China, 310016 The Second Affliated Hospital Of Wenzhou Medicial UniversityWenzhou, Zhejiang, China, 325000|Brno, Czechia, 602 00 Soukroma Gynekologicka AmbulanceFulnek, Czechia, 74245 Gynekologie Studentsky Dum S.R.O.Praha 6, Czechia, 160 00 Mudr. Ivana Salamonova S.R.O.Vysoke Myto, Czechia, 566 01|Atlanta, Georgia, United States, 30312 Agile Clinical Research Trials, LlcAtlanta, Georgia, United States, 30328 Atlanta Women'S Research Institute, Inc.Atlanta, Georgia, United States, 30342 Medisense, Inc.Atlanta, Georgia, United States, 30363 Atlanta Gynecology Research Institute, Inc.Suwanee, Georgia, United States, 30024 Clinical Research Consultants Of Altanta, LlcSuwanee, Georgia, United States, 30024|Afula, Israel, 1834111 Hillel Yaffe Medical CenterHadera, Israel, 3810101 Rambam Health CorporationHaifa, Israel, 3109601 Lady Davis Carmel Medical CenterHaifa, Israel, 3436212 Meir Medical CenterKfar Saba, Israel, 4428164|Hawkes Bay, New Zealand, 4130 P3 ResearchTauranga, New Zealand, 3110|Johannesburg, Gauteng, South Africa, 2193 Dr L Reynders PracticeLyttelton Manor, Gauteng, South Africa, 0141 Wilgeheuwel HospitalRoodepoort, Gauteng, South Africa, 1724|Durban, Kwazulu-Natal, South Africa, 4319 Ethekwini Hospital & Heart CentreDurban, Kwazulu-Natal, South Africa|Birmingham, Alabama, United States, 35294-0026|Chandler, Arizona, United States, 85224|Arcadia, California, United States, 91007 Sutter East Bay Medical CenterBerkeley, California, United States, 94704 Core Healthcare GroupCerritos, California, United States, 90703 Aviva ResearchEscondido, California, United States, 92025 National Research InstituteLos Angeles, California, United States, 90057 Harbor - Ucla Medical CenterTorrance, California, United States, 90509-2910|Newark, Delaware, United States, 10713|Aventura, Florida, United States, 33180 South Florida Medical ResearchAventura, Florida, United States, 33180 Helix Biomedics, LlcBoynton Beach, Florida, United States, 33436 Dr. Victoria Garcia & Associates, Llc Doral Medical ResearchDoral, Florida, United States, 33166 The Clinical Research InstituteHialeah, Florida, United States, 33012 Clinical Neurosciences Solutions, Inc. Dba Cns HealthcareJacksonville, Florida, United States, 322256 Axcess Medical Research, LlcLoxahatchee Groves, Florida, United States, 33470 Sweet Hope Research Specialty IncMiami Lakes, Florida, United States, 33016 Ocean Blue Medical Research Center, Inc.Miami Springs, Florida, United States, 33166 Serenity Holistic ObgynNorth Miami Beach, Florida, United States, 33162 Compass Research, LlcOrlando, Florida, United States, 32806 Ana Tomayo, MdPembroke Pines, Florida, United States, 33024 Discovery Clinical ResearchPlantation, Florida, United States, 33324 Oncova Clinical Research, Inc.Saint Cloud, Florida, United States, 34769 Univ.Of South Florida College Of MedicineTampa, Florida, United States, 33606|Park Ridge, Illinois, United States, 60068|Indianapolis, Indiana, United States, 46202|Shawnee Mission, Kansas, United States, 66218|Louisville, Kentucky, United States, 40202|Shreveport, Louisiana, United States, 71118|Baltimore, Maryland, United States, 21208 Simmonds, Martin And HelmbrechtGaithersburg, Maryland, United States, 20878 Advantia Health, Llc Obstetrics & Gynecology Assoc.Silver Spring, Maryland, United States, 20910|Brooklyn, New York, United States, 11203 University Of Rochester Medical CenterRochester, New York, United States, 14623|Asheville, North Carolina, United States, 28801 Carolinas Healthcare SystemCharlotte, North Carolina, United States, 28204 Unified Women'S Clinical Research - Morehead CityMorehead City, North Carolina, United States, 28557 Eastern Carolina Women'S CenterNew Bern, North Carolina, United States, 28562 Wake Forest Baptist HealthWinston-Salem, North Carolina, United States, 27103|Oklahoma City, Oklahoma, United States, 73104|Bryn Mawr, Pennsylvania, United States, 19010 Clinical Research Of Philadelphia, LlcPhiladelphia, Pennsylvania, United States, 19114|Charleston, South Carolina, United States, 29425 Fusion Clinical Research Of Spartanburg, LlcSpartanburg, South Carolina, United States, 29301 Invocare Clinical Research Center, LlcWest Columbia, South Carolina, United States, 29169|Chattanooga, Tennessee, United States, 37404 Clinical Neurosciences Solutions, Inc Dba Cns HealthcareMemphis, Tennessee, United States, 38119 Paramount Research SolutionsNashville, Tennessee, United States, 37203|Fort Worth, Texas, United States, 76104 Family Medicine ClinicGeorgetown, Texas, United States, 78626 The Center For Clinical Trials, Inc.Houston, Texas, United States, 77082 Biopharma Informatic, Inc.Houston, Texas, United States, 77084 Brownstone Clinical Trials, LlcIrving, Texas, United States, 75062 Houston Center For Clinical Research, LlcSugar Land, Texas, United States, 77479|Salt Lake City, Utah, United States, 84107|Arlington, Virginia, United States, 22207 Inova Fairfax HospitalFalls Church, Virginia, United States, 22042 Alliance Women'S HealthRichmond, Virginia, United States, 23226|Covington, Washington, United States, 98042 Dedicated Women'S Health Specialists, Inc.Puyallup, Washington, United States, 98372","Alabama|Arizona|California|Delaware|Florida|Illinois|Indiana|Kansas|Kentucky|Louisiana|Maryland|New York|North Carolina|Oklahoma|Pennsylvania|South Carolina|Tennessee|Texas|Utah|Virginia|Washington","Bulgaria|China|Czechia|Georgia|Israel|New Zealand|South Africa|United States","Multiprofile Hospital For Active Treatment-Dr. T. Venkova Ad|Beijing Hospital Of Traditional Chinese Medicine|Fujian Fuzhou General Hospital Of Nanjing Military Command|Guangdong Guangzhou Women And Children's Medical Center|Hainan Hainan General Hospital|Hubei Center For Reproductive Medicine,Tongji Medical College,Hust|Jiangsu Nanjing Maternity And Child Health Care Hospital|Jiangxi Jiangxi Maternal And Child Health Hospital|Jilin The First Hospital Of Jilin University|Liaoning The First Affiliated Hospital Of Dalian Medical University|Medical University|Ningxia General Hospital Of Ningxia Medical University|Second University Hospital|Shaanxi 1St Affiliated Hospital Of Xi'An Jiaotong Medical University|Shaanxi Second Affiliated Hospital Xian Jiaotong University School|Shanxi The Second Affiliated Hospital Of Shanxi Medical University|Xinjiang The First Affiliated Hospital Of Xinjiang Medical University|Zhejiang Women's Hospital School Of Medicine Zhejiang University|Gynekologie Meda S.R.O.|Center For Women|Haemek Medical Center|P3 Research Ltd Hawkes Bay|, Gauteng Wits Clinical Research Site|, Kwazulu-Natal Umhlanga Medical Centre|University Of Alabama At Birmingham|New Horizons Women's Care|Retina Institute Of California|Christiana Care Health System|Ideal Clinical Research|Advocate Lutheran|Iu Health University Hospital|Gtc Research|University Of Louisville|Omni Fertility And Laser Institute|Pharmasite Research, Inc.|Suny Downstate Medical Center|Asheville Women's Medical Center|Oklahoma University|Main Line Fertility Center|Medical University Of South Carolina|Chattanooga Medical Research, Llc|Texas Health Care, Pllc|Wasatch Clinical Research, Llc|Clinical Research Network|Multicare Health Systems Women's Health Care",{"$nulls":3},"Bayer Study Director","2018-04-23","2020-05-25T16:37:09.984","2020-05-26T17:10:42.972","NCT03400943"]
["5ecbf435feab101b155308b5","NCT03400943","2018-07-31","Bayer","BAYN","Recruiting","Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 3)","Bay-1002670|Vilaprisan","PR Modulator","Yes","['Bay-1002670', 'Vilaprisan']","No",null,"Phase 3",4,260,"Anticipated","2018-01-17","2020-05-20",{"$nulls":5},"The primary objective of this study is to show superiority in the treatment of HMB of vilaprisan in subjects with uterine fibroids compared to placebo.\n\nThe secondary objectives of this study are to additionally evaluate the efficacy and safety of vilaprisan in subjects with uterine fibroids.",null,"A Randomized, Parallel-group, Double-blind and Open-label Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Vilaprisan in Subjects With Uterine Fibroids",15787,"Leiomyoma","Leiomyoma|Myoma","Oncology Solid Tumor","Oncology","Experimental","Vilaprisan_A1|Vilaprisan_A2|Vilaprisan_B1|Vilaprisan_B2","vilaprisan (2 mg), 2 treatment periods of 12 weeks, separated by 1 bleeding episode|vilaprisan (2 mg), 2 treatment periods of 12 weeks without a break|placebo, 1 treatment period of 12 weeks, and vilaprisan (2 mg), 1 treatment period of 12 weeks, separated by 1 bleeding episode|vilaprisan (2 mg), 1 treatment period of 12 weeks, and placebo, 1 treatment period of 12 weeks, separated by 1 bleeding episode","Drug","Vilaprisan (BAY1002670)|Placebo","2 mg of Vilaprisan once daily up to 2 x 12 weeks|Matching placebo is administered to group B1 and B2.",null,"Vilaprisan_A1|Vilaprisan_A2|Vilaprisan_B1|Vilaprisan_B2","\n\n * Women, 18 years or older in good General health\n * Diagnosis of uterine fibroid(s) documented by ultrasound at screening with at least 1 fibroid with largest Diameter â‰¥ 30 mm and < 120 mm\n * Heavy menstrual bleeding (HMB) in at least 2 bleeding periods during the Screening period each with blood loss volume of >80.00 mL documented by alkaline hematin (AH) method\n * An endometrial biopsy performed during the Screening period without significant histological disorder such as endometrial hyperplasia (including simple hyperplasia) or other significant endometrial pathology\n * Use of an acceptable non-hormonal method of contraception (ie, either male condom, cap, diaphragm or sponge, each in combination with spermicide) starting at Visit 1 until the end of the study\n\n","\n\n * Pregnancy or lactation (less than 3 month since delivery, abortion, or lactation before start of Treatment)\n * Hypersensitivity to any ingredient of the study drug\n * Any condition requiring immediate blood transfusion\n * Laboratory values outside inclusion range before randomization and considered as clinically relevant.\n * Any diseases, conditions, or medications that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study drug\n * Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results\n * Abuse of alcohol, drugs, or medicines (eg, laxatives)\n * Use of other treatments that might interfere with the conduct of the study or the interpretation of the results\n * Undiagnosed abnormal genital bleeding",{"$nulls":4},"Actual","2018-01-17","Actual","Anticipated","2020-05-20","Anticipated","2018-07-01","2018-01-05","2018-01-15","2018-07-30","No","Uterine fibroids\nHeavy menstrual bleeding","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"Female",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"2017-002997-38","EudraCT Number","Amenorrhea (yes/no)","Amenorrhea (yes/no), defined as MBL <2 mL during the last 28 days of treatment.","The last 28 days of treatment period 1 and treatment period 2","Heavy Menstrual Bleeding (HMB) response|Time to onset of amenorrhea|Time to onset of controlled bleeding|Absence of bleeding (spotting allowed)|Endometrial histology|Endometrial thickness","HMB response defined as blood loss <80.00 mL during the last 28 days of treatment and >50% reduction compared to baseline|Onset of amenorrhea is defined by the first day for which the menstrual blood loss for all subsequent 28-day periods up to the end of the treatment period is <2 mL|By Uterine Fibroid Daily Bleeding Diary (UF-DBD)|Benign endometrium, presence or absence of hyperplasia or malignancy|Up to 36 weeks","The last 28 days of treatment period 1 and treatment period 2|In treatment period 1 (12 weeks) and in treatment period 2 (12 weeks)|Up to 36 weeks","clinical-trials-contact@bayer.com","Bayer Clinical Trials Contact","(+) 1-888-8422937","Gabrovo, Bulgaria, 5300 Hospital For Active Treatment - Prof.Paraskev Stoyanov AdLovech, Bulgaria, 5500 Mhat Dr. Bratan Shukerov AdSmolyan, Bulgaria, 4700 Mhat For Women'S Health - Nadezhda OodSofia, Bulgaria, 1330|Beijing, China, 100010 Peking University First HospitalBeijing, China, 100034 Beijing Friendship Hospital, Capital Medical UniversityBeijing, China, 100050 Beijing Tiantan Hospital, Captial Medical UniversityBeijing, China, 100050 International Peace Maternity&Child Health Hospital Of CwiShanghai, China, 200030 Shanghai First Maternity And Infant HospitalShanghai, China, 200040 Shanghai General HospitalShanghai, China, 200080 Shanghai East Hospital Affiated To Tongji UniversityShanghai, China, 200123 Tianjin Medical University General HospitalTianjin, China, 300052 First Teaching Hosptial Of Tianjin University Of TcmTianjin, China, 300193 Tianjin Central Hospital Of Gynecology ObstetricsTianjin, China, 300199|Fuzhou, Fujian, China, 350025|Guangzhou, Guangdong, China, 510623 The Third Affiliated Hospital, Sun Yat-Sen UniversityGuangzhou, Guangdong, China, 510630 Boai Hospital Of ZhongshanZhongshan, Guangdong, China|Haikou, Hainan, China, 570311|Shijiazhuang, Hebei, China, 050000|Wuhan, Hubei, China, 430013|Nanjing, Jiangsu, China, 210004 Nanjing First HospitalNanjing, Jiangsu, China, 210006 Nj Drum Tower Hospital, The Affil Hos Of Nj Univ Med SchoolNanjing, Jiangsu, China, 210008 Zhongda Hospital Southeast UniversityNanjing, Jiangsu, China, 210009 1St Affiliated Hospital Of Soochow UniversitySuzhou, Jiangsu, China, 215006|Nanchang, Jiangxi, China, 330006 The Second Affiliated Hospital Of Nanchang UniversityNanchang, Jiangxi, China, 330006|Changchun, Jilin, China, 130021|Dalian, Liaoning, China, 116011 Shengjing Hospital Of|Shenyang, Liaoning, China, 110004|Yinchuan, Ningxia, China, 750004|Chengdu, Sichuan, China, 610041|Xi'An, Shaanxi, China, 710061|Xi'An, Shaanxi, China, 710004|Taiyuan, Shanxi, China, 030001|Urumqi, Xinjiang, China, 830054|Hangzhou, Zhejiang, China, 310006 Sir Run Run Shaw Hospital, Zhejiang Univ. School Of MedicineHangzhou, Zhejiang, China, 310016 The Second Affliated Hospital Of Wenzhou Medicial UniversityWenzhou, Zhejiang, China, 325000|Brno, Czechia, 602 00 Soukroma Gynekologicka AmbulanceFulnek, Czechia, 74245 Gynekologie Studentsky Dum S.R.O.Praha 6, Czechia, 160 00 Mudr. Ivana Salamonova S.R.O.Vysoke Myto, Czechia, 566 01|Atlanta, Georgia, United States, 30312 Agile Clinical Research Trials, LlcAtlanta, Georgia, United States, 30328 Atlanta Women'S Research Institute, Inc.Atlanta, Georgia, United States, 30342 Medisense, Inc.Atlanta, Georgia, United States, 30363 Paramount Research SolutionsCollege Park, Georgia, United States, 30349 Fellows Research AllianceSavannah, Georgia, United States, 31406 Atlanta Gynecology Research Institute, Inc.Suwanee, Georgia, United States, 30024 Clinical Research Consultants Of Altanta, LlcSuwanee, Georgia, United States, 30024|Afula, Israel, 1834111 Hillel Yaffe Medical CenterHadera, Israel, 3810101 Rambam Health CorporationHaifa, Israel, 3109601 Lady Davis Carmel Medical CenterHaifa, Israel, 3436212 Meir Medical CenterKfar Saba, Israel, 4428164|Hawkes Bay, New Zealand, 4130 P3 ResearchTauranga, New Zealand, 3110|Johannesburg, Gauteng, South Africa, 2193 Dr L Reynders PracticeLyttelton Manor, Gauteng, South Africa, 0141 Wilgeheuwel HospitalRoodepoort, Gauteng, South Africa, 1724|Durban, Kwazulu-Natal, South Africa, 4319 Ethekwini Hospital & Heart CentreDurban, Kwazulu-Natal, South Africa|Birmingham, Alabama, United States, 35294-0026|Chandler, Arizona, United States, 85224|Arcadia, California, United States, 91007 Sutter East Bay Medical CenterBerkeley, California, United States, 94704 Core Healthcare GroupCerritos, California, United States, 90703 Aviva ResearchEscondido, California, United States, 92025 National Research InstituteLos Angeles, California, United States, 90057 Harbor - Ucla Medical CenterTorrance, California, United States, 90509-2910|Newark, Delaware, United States, 10713|Aventura, Florida, United States, 33180 South Florida Medical ResearchAventura, Florida, United States, 33180 Helix Biomedics, LlcBoynton Beach, Florida, United States, 33436 Dr. Victoria Garcia & Associates, Llc Doral Medical ResearchDoral, Florida, United States, 33166 Dolphine Medical ResearchDoral, Florida, United States, 33172 The Clinical Research InstituteHialeah, Florida, United States, 33012 Clinical Neurosciences Solutions, Inc. Dba Cns HealthcareJacksonville, Florida, United States, 322256 Altus ResearchLake Worth, Florida, United States, 33461 Axcess Medical Research, LlcLoxahatchee Groves, Florida, United States, 33470 Sweet Hope Research Specialty IncMiami Lakes, Florida, United States, 33016 Ocean Blue Medical Research Center, Inc.Miami Springs, Florida, United States, 33166 Serenity Holistic ObgynMiami, Florida, United States, 33181 Compass Research, LlcOrlando, Florida, United States, 32806 Ana Tomayo, MdPembroke Pines, Florida, United States, 33024 Discovery Clinical ResearchPlantation, Florida, United States, 33324 Oncova Clinical Research, Inc.Saint Cloud, Florida, United States, 34769 Univ.Of South Florida College Of MedicineTampa, Florida, United States, 33606|Chicago, Illinois, United States, 60612 Advocate LutheranPark Ridge, Illinois, United States, 60068|Indianapolis, Indiana, United States, 46202|Shawnee Mission, Kansas, United States, 66218|Louisville, Kentucky, United States, 40202|Shreveport, Louisiana, United States, 71118|Baltimore, Maryland, United States, 21208 Simmonds, Martin And HelmbrechtGaithersburg, Maryland, United States, 20878 Advantia Health, Llc Obstetrics & Gynecology Assoc.Silver Spring, Maryland, United States, 20910|Brooklyn, New York, United States, 11203 University Of Rochester Medical CenterRochester, New York, United States, 14623|Asheville, North Carolina, United States, 28801 Carolinas Healthcare SystemCharlotte, North Carolina, United States, 28204 Unified Women'S Clinical Research - Morehead CityMorehead City, North Carolina, United States, 28557 Eastern Carolina Women'S CenterNew Bern, North Carolina, United States, 28562 Wake Research AsssociatesRaleigh, North Carolina, United States, 27612 Wake Forest Baptist HealthWinston-Salem, North Carolina, United States, 27103|Oklahoma City, Oklahoma, United States, 73104|Bryn Mawr, Pennsylvania, United States, 19010 Clinical Research Of Philadelphia, LlcPhiladelphia, Pennsylvania, United States, 19114|Bluffton, South Carolina, United States, 29910 Medical University Of South CarolinaCharleston, South Carolina, United States, 29425 Fusion Clinical Research Of Spartanburg, LlcSpartanburg, South Carolina, United States, 29301 Invocare Clinical Research Center, LlcWest Columbia, South Carolina, United States, 29169|Chattanooga, Tennessee, United States, 37404 Clinical Neurosciences Solutions, Inc Dba Cns HealthcareMemphis, Tennessee, United States, 38119 Paramount Research SolutionsNashville, Tennessee, United States, 37203|Fort Worth, Texas, United States, 76104 Texas Health Care, PllcFort Worth, Texas, United States, 76104 Willowbend Health & Wellness AssociatesFrisco, Texas, United States, 75035 Family Medicine ClinicGeorgetown, Texas, United States, 78626 Biopharma Informatic, Inc.Houston, Texas, United States, 77043 Centex Studies, Inc.Houston, Texas, United States, 77058 The Center For Clinical Trials, Inc.Houston, Texas, United States, 77082 Houston Center For Clinical Research, LlcSugar Land, Texas, United States, 77479|Salt Lake City, Utah, United States, 84107|Arlington, Virginia, United States, 22207 Inova Fairfax HospitalFalls Church, Virginia, United States, 22042 Synexus Research, LlcRichmond, Virginia, United States, 23226|Covington, Washington, United States, 98042 Dedicated Women'S Health Specialists, Inc.Puyallup, Washington, United States, 98372","Alabama|Arizona|California|Delaware|Florida|Illinois|Indiana|Kansas|Kentucky|Louisiana|Maryland|New York|North Carolina|Oklahoma|Pennsylvania|South Carolina|Tennessee|Texas|Utah|Virginia|Washington","Bulgaria|China|Czechia|Georgia|Israel|New Zealand|South Africa|United States","Multiprofile Hospital For Active Treatment-Dr. T. Venkova Ad|Beijing Hospital Of Traditional Chinese Medicine|Fujian Fuzhou General Hospital Of Nanjing Military Command|Guangdong Guangzhou Women And Children's Medical Center|Hainan Hainan General Hospital|Hebei The 2Nd Hospital Of Hebei Medical University|Hubei Center For Reproductive Medicine,Tongji Medical College,Hust|Jiangsu Nanjing Maternity And Child Health Care Hospital|Jiangxi Jiangxi Maternal And Child Health Hospital|Jilin The First Hospital Of Jilin University|Liaoning The First Affiliated Hospital Of Dalian Medical University|Medical University|Ningxia General Hospital Of Ningxia Medical University|Second University Hospital|Shaanxi 1St Affiliated Hospital Of Xi'An Jiaotong Medical University|Shaanxi Second Affiliated Hospital Xian Jiaotong University School|Shanxi The Second Affiliated Hospital Of Shanxi Medical University|Xinjiang The First Affiliated Hospital Of Xinjiang Medical University|Zhejiang Women's Hospital School Of Medicine Zhejiang University|Gynekologie Meda S.R.O.|Center For Women|Haemek Medical Center|P3 Research Ltd Hawkes Bay|, Gauteng Wits Clinical Research Site|, Kwazulu-Natal Umhlanga Medical Centre|University Of Alabama At Birmingham|New Horizons Women's Care|California Center For Clinical Research|Christiana Care Health System|Ideal Clinical Research|University Of Illinois At Chicago|Iu Health University Hospital|Gtc Research|University Of Louisville|Omni Fertility And Laser Institute|Pharmasite Research, Inc.|Suny Downstate Medical Center|Asheville Women's Medical Center|Oklahoma University|Main Line Fertility Center|Fellows Research Alliance, Inc.|Chattanooga Medical Research, Llc|Brownstone Clinical Trials, Llc|Wasatch Clinical Research, Llc|Clinical Research Network|Multicare Health Systems Women's Health Care",{"$nulls":3},"Bayer Study Director","2018-07-30","2020-05-25T16:37:09.971","2020-05-26T17:10:42.972","NCT03400943"]
["5ecbf43611702c1b1b916a95","NCT03400943","2018-10-01","Bayer","BAYN","Recruiting","Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 3)","Bay-1002670|Vilaprisan","PR Modulator","Yes","['Bay-1002670', 'Vilaprisan']","No",null,"Phase 3",4,260,"Anticipated","2018-01-17","2020-05-20",{"$nulls":5},"The primary objective of this study is to show superiority in the treatment of HMB of vilaprisan in subjects with uterine fibroids compared to placebo.\n\nThe secondary objectives of this study are to additionally evaluate the efficacy and safety of vilaprisan in subjects with uterine fibroids.",null,"A Randomized, Parallel-group, Double-blind and Open-label Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Vilaprisan in Subjects With Uterine Fibroids",15787,"Leiomyoma","Leiomyoma|Myoma","Oncology Solid Tumor","Oncology","Experimental","Vilaprisan_A1|Vilaprisan_A2|Vilaprisan_B1|Vilaprisan_B2","vilaprisan (2 mg), 2 treatment periods of 12 weeks, separated by 1 bleeding episode|vilaprisan (2 mg), 2 treatment periods of 12 weeks without a break|placebo, 1 treatment period of 12 weeks, and vilaprisan (2 mg), 1 treatment period of 12 weeks, separated by 1 bleeding episode|vilaprisan (2 mg), 1 treatment period of 12 weeks, and placebo, 1 treatment period of 12 weeks, separated by 1 bleeding episode","Drug","Vilaprisan (BAY1002670)|Placebo","2 mg of Vilaprisan once daily up to 2 x 12 weeks|Matching placebo is administered to group B1 and B2.",null,"Vilaprisan_A1|Vilaprisan_A2|Vilaprisan_B1|Vilaprisan_B2","\n\n * Women, 18 years or older in good General health\n * Diagnosis of uterine fibroid(s) documented by ultrasound at screening with at least 1 fibroid with largest Diameter â‰¥ 30 mm and < 120 mm\n * Heavy menstrual bleeding (HMB) in at least 2 bleeding periods during the Screening period each with blood loss volume of >80.00 mL documented by alkaline hematin (AH) method\n * An endometrial biopsy performed during the Screening period without significant histological disorder such as endometrial hyperplasia (including simple hyperplasia) or other significant endometrial pathology\n * Use of an acceptable non-hormonal method of contraception (ie, either male condom, cap, diaphragm or sponge, each in combination with spermicide) starting at Visit 1 until the end of the study\n\n","\n\n * Pregnancy or lactation (less than 3 month since delivery, abortion, or lactation before start of Treatment)\n * Hypersensitivity to any ingredient of the study drug\n * Any condition requiring immediate blood transfusion\n * Laboratory values outside inclusion range before randomization and considered as clinically relevant.\n * Any diseases, conditions, or medications that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study drug\n * Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results\n * Abuse of alcohol, drugs, or medicines (eg, laxatives)\n * Use of other treatments that might interfere with the conduct of the study or the interpretation of the results\n * Undiagnosed abnormal genital bleeding",{"$nulls":4},"Actual","2018-01-17","Actual","Anticipated","2020-05-20","Anticipated","2018-09-01","2018-01-05","2018-01-15","2018-09-28","No","Uterine fibroids\nHeavy menstrual bleeding","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"Female",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"2017-002997-38","EudraCT Number","Amenorrhea (yes/no)","Amenorrhea (yes/no), defined as MBL <2 mL during the last 28 days of treatment.","The last 28 days of treatment period 1 and treatment period 2","Heavy Menstrual Bleeding (HMB) response|Time to onset of amenorrhea|Time to onset of controlled bleeding|Absence of bleeding (spotting allowed)|Endometrial histology|Endometrial thickness","HMB response defined as blood loss <80.00 mL during the last 28 days of treatment and >50% reduction compared to baseline|Onset of amenorrhea is defined by the first day for which the menstrual blood loss for all subsequent 28-day periods up to the end of the treatment period is <2 mL|By Uterine Fibroid Daily Bleeding Diary (UF-DBD)|Benign endometrium, presence or absence of hyperplasia or malignancy|Up to 36 weeks","The last 28 days of treatment period 1 and treatment period 2|In treatment period 1 (12 weeks) and in treatment period 2 (12 weeks)|Up to 36 weeks","clinical-trials-contact@bayer.com","Bayer Clinical Trials Contact","(+) 1-888-8422937","Gabrovo, Bulgaria, 5300 Hospital For Active Treatment - Prof.Paraskev Stoyanov AdLovech, Bulgaria, 5500 Mhat Dr. Bratan Shukerov AdSmolyan, Bulgaria, 4700 Mhat For Women'S Health - Nadezhda OodSofia, Bulgaria, 1330|Hefei, Anhui, China, 230022|Beijing, China, 100010 Peking University First HospitalBeijing, China, 100034 Beijing Friendship Hospital, Capital Medical UniversityBeijing, China, 100050 Beijing Tiantan Hospital, Captial Medical UniversityBeijing, China, 100050 International Peace Maternity&Child Health Hospital Of CwiShanghai, China, 200030 Shanghai First Maternity And Infant HospitalShanghai, China, 200040 Shanghai General HospitalShanghai, China, 200080 Shanghai East Hospital Affiated To Tongji UniversityShanghai, China, 200123 Tianjin Medical University General Hospital[Active, Not Recruiting]Tianjin, China, 300052 First Teaching Hosptial Of Tianjin University Of TcmTianjin, China, 300193 Tianjin Central Hospital Of Gynecology ObstetricsTianjin, China, 300199|Fuzhou, Fujian, China, 350025|Lanzhou, Gansu, China, 730030|Guangzhou, Guangdong, China, 510623 The Third Affiliated Hospital, Sun Yat-Sen UniversityGuangzhou, Guangdong, China, 510630 Boai Hospital Of ZhongshanZhongshan, Guangdong, China|Haikou, Hainan, China, 570311|Shijiazhuang, Hebei, China, 050000|Wuhan, Hubei, China, 430013|Nanjing, Jiangsu, China, 210004 Nanjing First HospitalNanjing, Jiangsu, China, 210006 Nj Drum Tower Hospital, The Affil Hos Of Nj Univ Med SchoolNanjing, Jiangsu, China, 210008 Zhongda Hospital Southeast UniversityNanjing, Jiangsu, China, 210009 The Second Affiliated Hospital Of Nanjing Medical UniversityNanjing, Jiangsu, China, 210011 1St Affiliated Hospital Of Soochow UniversitySuzhou, Jiangsu, China, 215006|Nanchang, Jiangxi, China, 330006 The Second Affiliated Hospital Of Nanchang UniversityNanchang, Jiangxi, China, 330006|Changchun, Jilin, China, 130000 The First Hospital Of Jilin UniversityChangchun, Jilin, China, 130021|Dalian, Liaoning, China, 116011 Shengjing Hospital Of|Shenyang, Liaoning, China, 110004|Yinchuan, Ningxia, China, 750004|Chengdu, Sichuan, China, 610041|Xi'An, Shaanxi, China, 710061|Xi'An, Shaanxi, China, 710004|Taiyuan, Shanxi, China, 030001|Urumqi, Xinjiang, China, 830054|Hangzhou, Zhejiang, China, 310006 Sir Run Run Shaw Hospital, Zhejiang Univ. School Of MedicineHangzhou, Zhejiang, China, 310016 The First Affiliated Hospital Of Wenzhou Medical Univ (New)Wenzhou, Zhejiang, China, 325000 The Second Affliated Hospital Of Wenzhou Medicial UniversityWenzhou, Zhejiang, China, 325000|Brno, Czechia, 602 00 Soukroma Gynekologicka AmbulanceFulnek, Czechia, 74245 Gynekologie Studentsky Dum S.R.O.Praha 6, Czechia, 160 00 Mudr. Ivana Salamonova S.R.O.Vysoke Myto, Czechia, 566 01|Atlanta, Georgia, United States, 30312 Agile Clinical Research Trials, LlcAtlanta, Georgia, United States, 30328 Atlanta Women'S Research Institute, Inc.Atlanta, Georgia, United States, 30342 Medisense, Inc.Atlanta, Georgia, United States, 30363 Paramount Research SolutionsCollege Park, Georgia, United States, 30349 Fellows Research AllianceSavannah, Georgia, United States, 31406 Atlanta Gynecology Research Institute, Inc.Suwanee, Georgia, United States, 30024 Clinical Research Consultants Of Altanta, LlcSuwanee, Georgia, United States, 30024|Afula, Israel, 1834111 Hillel Yaffe Medical CenterHadera, Israel, 3810101 Rambam Health CorporationHaifa, Israel, 3109601 Lady Davis Carmel Medical CenterHaifa, Israel, 3436212 Meir Medical CenterKfar Saba, Israel, 4428164|Hawkes Bay, New Zealand, 4130 P3 ResearchTauranga, New Zealand, 3110|Johannesburg, Gauteng, South Africa, 2193 Dr L Reynders PracticeLyttelton Manor, Gauteng, South Africa, 0141 Wilgeheuwel HospitalRoodepoort, Gauteng, South Africa, 1724|Durban, Kwazulu-Natal, South Africa, 4319 Ethekwini Hospital & Heart CentreDurban, Kwazulu-Natal, South Africa|Birmingham, Alabama, United States, 35294-0026|Chandler, Arizona, United States, 85224|Arcadia, California, United States, 91007 Sutter East Bay Medical CenterBerkeley, California, United States, 94704 Core Healthcare GroupCerritos, California, United States, 90703 Aviva ResearchEscondido, California, United States, 92025 National Research InstituteLos Angeles, California, United States, 90057 Harbor - Ucla Medical CenterTorrance, California, United States, 90509-2910|Newark, Delaware, United States, 10713|Aventura, Florida, United States, 33180 South Florida Medical ResearchAventura, Florida, United States, 33180 Helix Biomedics, LlcBoynton Beach, Florida, United States, 33436 Dr. Victoria Garcia & Associates, Llc Doral Medical ResearchDoral, Florida, United States, 33166 Dolphine Medical ResearchDoral, Florida, United States, 33172 The Clinical Research InstituteHialeah, Florida, United States, 33012 Clinical Neurosciences Solutions, Inc. Dba Cns HealthcareJacksonville, Florida, United States, 322256 Altus ResearchLake Worth, Florida, United States, 33461 Axcess Medical Research, LlcLoxahatchee Groves, Florida, United States, 33470 Sweet Hope Research Specialty IncMiami Lakes, Florida, United States, 33016 Ocean Blue Medical Research Center, Inc.Miami Springs, Florida, United States, 33166 Serenity Holistic ObgynMiami, Florida, United States, 33181 Aventura Clinical Research, LlcMiramar, Florida, United States, 33027 Compass Research, LlcOrlando, Florida, United States, 32806 Ana Tomayo, MdPembroke Pines, Florida, United States, 33024 Discovery Clinical ResearchPlantation, Florida, United States, 33324 Oncova Clinical Research, Inc.Saint Cloud, Florida, United States, 34769 Univ.Of South Florida College Of MedicineTampa, Florida, United States, 33606|Chicago, Illinois, United States, 60612 Advocate LutheranPark Ridge, Illinois, United States, 60068|Indianapolis, Indiana, United States, 46202|Shawnee Mission, Kansas, United States, 66218|Louisville, Kentucky, United States, 40202|Shreveport, Louisiana, United States, 71118|Baltimore, Maryland, United States, 21208 Simmonds, Martin And HelmbrechtGaithersburg, Maryland, United States, 20878 Advantia Health, Llc Obstetrics & Gynecology Assoc.Silver Spring, Maryland, United States, 20910|Brooklyn, New York, United States, 11203 University Of Rochester Medical CenterRochester, New York, United States, 14623|Asheville, North Carolina, United States, 28801 Carolinas Healthcare SystemCharlotte, North Carolina, United States, 28204 Unified Women'S Clinical Research - Morehead CityMorehead City, North Carolina, United States, 28557 Eastern Carolina Women'S CenterNew Bern, North Carolina, United States, 28562 Wake Research AsssociatesRaleigh, North Carolina, United States, 27612 Wake Forest Baptist HealthWinston-Salem, North Carolina, United States, 27103|Oklahoma City, Oklahoma, United States, 73104|Bryn Mawr, Pennsylvania, United States, 19010 Clinical Research Of Philadelphia, LlcPhiladelphia, Pennsylvania, United States, 19114|Bluffton, South Carolina, United States, 29910 Medical University Of South CarolinaCharleston, South Carolina, United States, 29425 Fusion Clinical Research Of Spartanburg, LlcSpartanburg, South Carolina, United States, 29301 Invocare Clinical Research Center, LlcWest Columbia, South Carolina, United States, 29169|Chattanooga, Tennessee, United States, 37404 Clinical Neurosciences Solutions, Inc Dba Cns HealthcareMemphis, Tennessee, United States, 38119 Paramount Research SolutionsNashville, Tennessee, United States, 37203|Fort Worth, Texas, United States, 76104 Texas Health Care, PllcFort Worth, Texas, United States, 76104 Willowbend Health & Wellness AssociatesFrisco, Texas, United States, 75035 Family Medicine ClinicGeorgetown, Texas, United States, 78626 Biopharma Informatic, Inc.Houston, Texas, United States, 77043 Centex Studies, Inc.Houston, Texas, United States, 77058 The Center For Clinical Trials, Inc.Houston, Texas, United States, 77082 Houston Center For Clinical Research, LlcSugar Land, Texas, United States, 77479|Salt Lake City, Utah, United States, 84107|Arlington, Virginia, United States, 22207 Inova Fairfax HospitalFalls Church, Virginia, United States, 22042 Synexus Research, LlcRichmond, Virginia, United States, 23226|Covington, Washington, United States, 98042 Dedicated Women'S Health Specialists, Inc.Puyallup, Washington, United States, 98372","Alabama|Arizona|California|Delaware|Florida|Illinois|Indiana|Kansas|Kentucky|Louisiana|Maryland|New York|North Carolina|Oklahoma|Pennsylvania|South Carolina|Tennessee|Texas|Utah|Virginia|Washington","Bulgaria|China|Czechia|Georgia|Israel|New Zealand|South Africa|United States","Multiprofile Hospital For Active Treatment-Dr. T. Venkova Ad|Anhui The First Affiliated Hospital Of Anhui Medical University|Beijing Hospital Of Traditional Chinese Medicine|Fujian Fuzhou General Hospital Of Nanjing Military Command|Gansu Lanzhou University Second Hospital|Guangdong Guangzhou Women And Children's Medical Center|Hainan Hainan General Hospital|Hebei The 2Nd Hospital Of Hebei Medical University|Hubei Center For Reproductive Medicine,Tongji Medical College,Hust|Jiangsu Nanjing Maternity And Child Health Care Hospital|Jiangxi Jiangxi Maternal And Child Health Hospital|Jilin The Second Hospital Of Jilin University|Liaoning The First Affiliated Hospital Of Dalian Medical University|Medical University|Ningxia General Hospital Of Ningxia Medical University|Second University Hospital|Shaanxi 1St Affiliated Hospital Of Xi'An Jiaotong Medical University|Shaanxi Second Affiliated Hospital Xian Jiaotong University School|Shanxi The Second Affiliated Hospital Of Shanxi Medical University|Xinjiang The First Affiliated Hospital Of Xinjiang Medical University|Zhejiang Women's Hospital School Of Medicine Zhejiang University|Gynekologie Meda S.R.O.|Center For Women|Haemek Medical Center|P3 Research Ltd Hawkes Bay|, Gauteng Wits Clinical Research Site|, Kwazulu-Natal Umhlanga Medical Centre|University Of Alabama At Birmingham|New Horizons Women's Care|California Center For Clinical Research|Christiana Care Health System|Ideal Clinical Research|University Of Illinois At Chicago|Iu Health University Hospital|Gtc Research|University Of Louisville|Omni Fertility And Laser Institute|Pharmasite Research, Inc.|Suny Downstate Medical Center|Asheville Women's Medical Center|Oklahoma University|Main Line Fertility Center|Fellows Research Alliance, Inc.|Chattanooga Medical Research, Llc|Brownstone Clinical Trials, Llc|Wasatch Clinical Research, Llc|Clinical Research Network|Multicare Health Systems Women's Health Care",{"$nulls":3},"Bayer Study Director","2018-09-28","2020-05-25T16:37:10.117","2020-05-26T17:10:42.972","NCT03400943"]
["5ecbf437feab101b155308b7","NCT03400943","2019-01-10","Bayer","BAYN","Active, not recruiting","Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 3)","Bay-1002670|Vilaprisan","PR Modulator","Yes","['Bay-1002670', 'Vilaprisan']","No",null,"Phase 3",4,260,"Anticipated","2018-01-17","2020-05-20",{"$nulls":5},"The primary objective of this study is to show superiority in the treatment of HMB of vilaprisan in subjects with uterine fibroids compared to placebo.\n\nThe secondary objectives of this study are to additionally evaluate the efficacy and safety of vilaprisan in subjects with uterine fibroids.",null,"A Randomized, Parallel-group, Double-blind and Open-label Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Vilaprisan in Subjects With Uterine Fibroids",15787,"Leiomyoma","Leiomyoma|Myoma","Oncology Solid Tumor","Oncology","Experimental","Vilaprisan_A1|Vilaprisan_A2|Vilaprisan_B1|Vilaprisan_B2","vilaprisan (2 mg), 2 treatment periods of 12 weeks, separated by 1 bleeding episode|vilaprisan (2 mg), 2 treatment periods of 12 weeks without a break|placebo, 1 treatment period of 12 weeks, and vilaprisan (2 mg), 1 treatment period of 12 weeks, separated by 1 bleeding episode|vilaprisan (2 mg), 1 treatment period of 12 weeks, and placebo, 1 treatment period of 12 weeks, separated by 1 bleeding episode","Drug","Vilaprisan (BAY1002670)|Placebo","2 mg of Vilaprisan once daily up to 2 x 12 weeks|Matching placebo is administered to group B1 and B2.",null,"Vilaprisan_A1|Vilaprisan_A2|Vilaprisan_B1|Vilaprisan_B2","\n\n * Women, 18 years or older in good General health\n * Diagnosis of uterine fibroid(s) documented by ultrasound at screening with at least 1 fibroid with largest Diameter â‰¥ 30 mm and < 120 mm\n * Heavy menstrual bleeding (HMB) in at least 2 bleeding periods during the Screening period each with blood loss volume of >80.00 mL documented by alkaline hematin (AH) method\n * An endometrial biopsy performed during the Screening period without significant histological disorder such as endometrial hyperplasia (including simple hyperplasia) or other significant endometrial pathology\n * Use of an acceptable non-hormonal method of contraception (ie, either male condom, cap, diaphragm or sponge, each in combination with spermicide) starting at Visit 1 until the end of the study\n\n","\n\n * Pregnancy or lactation (less than 3 month since delivery, abortion, or lactation before start of Treatment)\n * Hypersensitivity to any ingredient of the study drug\n * Any condition requiring immediate blood transfusion\n * Laboratory values outside inclusion range before randomization and considered as clinically relevant.\n * Any diseases, conditions, or medications that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study drug\n * Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results\n * Abuse of alcohol, drugs, or medicines (eg, laxatives)\n * Use of other treatments that might interfere with the conduct of the study or the interpretation of the results\n * Undiagnosed abnormal genital bleeding",{"$nulls":4},"Actual","2018-01-17","Actual","Anticipated","2020-05-20","Anticipated","2019-01-01","2018-01-05","2018-01-15","2019-01-09","No","Uterine fibroids\nHeavy menstrual bleeding","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"Female",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"2017-002997-38","EudraCT Number","Amenorrhea (yes/no)","Amenorrhea (yes/no), defined as MBL <2 mL during the last 28 days of treatment.","The last 28 days of treatment period 1 and treatment period 2","Heavy Menstrual Bleeding (HMB) response|Time to onset of amenorrhea|Time to onset of controlled bleeding|Absence of bleeding (spotting allowed)|Endometrial histology|Endometrial thickness","HMB response defined as blood loss <80.00 mL during the last 28 days of treatment and >50% reduction compared to baseline|Onset of amenorrhea is defined by the first day for which the menstrual blood loss for all subsequent 28-day periods up to the end of the treatment period is <2 mL|By Uterine Fibroid Daily Bleeding Diary (UF-DBD)|Benign endometrium, presence or absence of hyperplasia or malignancy|Up to 36 weeks","The last 28 days of treatment period 1 and treatment period 2|In treatment period 1 (12 weeks) and in treatment period 2 (12 weeks)|Up to 36 weeks",{"$nulls":3},"Gabrovo, Bulgaria, 5300 Hospital For Active Treatment - Prof.Paraskev Stoyanov AdLovech, Bulgaria, 5500 Mhat Dr. Bratan Shukerov AdSmolyan, Bulgaria, 4700 Mhat For Women'S Health - Nadezhda OodSofia, Bulgaria, 1330|Beijing, China, 100010 Peking University First HospitalBeijing, China, 100034 Beijing Friendship Hospital, Capital Medical UniversityBeijing, China, 100050 Beijing Tiantan Hospital, Captial Medical UniversityBeijing, China, 100050 Beijing Luhe Hospital Of Capital Medicial UniversityBeijing, China, 101199 Shanghai East Hospital Affiated To Tongji UniversityShanghai, China, 200123 Tianjin Medical University General HospitalTianjin, China, 300052 Tianjin Central Hospital Of Gynecology ObstetricsTianjin, China, 300199|Fuzhou, Fujian, China, 350025|Lanzhou, Gansu, China, 730030|Guangzhou, Guangdong, China, 510623 The Third Affiliated Hospital, Sun Yat-Sen UniversityGuangzhou, Guangdong, China, 510630 Boai Hospital Of ZhongshanZhongshan, Guangdong, China|Nanning, Guangxi, China, 530021|Haikou, Hainan, China, 570311|Shijiazhuang, Hebei, China, 050000|Wuhan, Hubei, China, 430013|Nanjing, Jiangsu, China, 210004 Nanjing First HospitalNanjing, Jiangsu, China, 210006 Nj Drum Tower Hospital, The Affil Hos Of Nj Univ Med SchoolNanjing, Jiangsu, China, 210008 Zhongda Hospital Southeast UniversityNanjing, Jiangsu, China, 210009 The Second Affiliated Hospital Of Nanjing Medical UniversityNanjing, Jiangsu, China, 210011 1St Affiliated Hospital Of Soochow UniversitySuzhou, Jiangsu, China, 215006|Nanchang, Jiangxi, China, 330006 The Second Affiliated Hospital Of Nanchang UniversityNanchang, Jiangxi, China, 330006|Changchun, Jilin, China, 130000 The First Hospital Of Jilin UniversityChangchun, Jilin, China, 130021|Dalian, Liaoning, China, 116011 Shengjing Hospital Of|Shenyang, Liaoning, China, 110004|Yinchuan, Ningxia, China, 750004|Chengdu, Sichuan, China, 610041|Xi'An, Shaanxi, China, 710061|Xi'An, Shaanxi, China, 710004|Taiyuan, Shanxi, China, 030001|Urumqi, Xinjiang, China, 830054|Hangzhou, Zhejiang, China, 310006 Sir Run Run Shaw Hospital, Zhejiang Univ. School Of MedicineHangzhou, Zhejiang, China, 310016 The First Affiliated Hospital Of Wenzhou Medical Univ (New)Wenzhou, Zhejiang, China, 325000 The Second Affliated Hospital Of Wenzhou Medicial UniversityWenzhou, Zhejiang, China, 325000|Brno, Czechia, 602 00 Soukroma Gynekologicka AmbulanceFulnek, Czechia, 74245 Gynekologie Studentsky Dum S.R.O.Praha 6, Czechia, 160 00 Mudr. Ivana Salamonova S.R.O.Vysoke Myto, Czechia, 566 01|Atlanta, Georgia, United States, 30312 Agile Clinical Research Trials, LlcAtlanta, Georgia, United States, 30328 Atlanta Women'S Research Institute, Inc.Atlanta, Georgia, United States, 30342 Medisense, Inc.Atlanta, Georgia, United States, 30363 Paramount Research SolutionsCollege Park, Georgia, United States, 30349 Atlanta Gynecology Research InstitutePeachtree Corners, Georgia, United States, 30092 Fellows Research AllianceSavannah, Georgia, United States, 31406|Afula, Israel, 1834111 Hillel Yaffe Medical CenterHadera, Israel, 3810101 Rambam Health CorporationHaifa, Israel, 3109601 Lady Davis Carmel Medical CenterHaifa, Israel, 3436212 Meir Medical CenterKfar Saba, Israel, 4428164|Hawkes Bay, New Zealand, 4130 P3 ResearchTauranga, New Zealand, 3110|Johannesburg, Gauteng, South Africa, 2193 Dr L Reynders PracticeLyttelton Manor, Gauteng, South Africa, 0141 Wilgeheuwel HospitalRoodepoort, Gauteng, South Africa, 1724|Durban, Kwazulu-Natal, South Africa, 4319 Ethekwini Hospital & Heart CentreDurban, Kwazulu-Natal, South Africa|Birmingham, Alabama, United States, 35294-0026|Arcadia, California, United States, 91007 Core Healthcare GroupCerritos, California, United States, 90703 Aviva ResearchEscondido, California, United States, 92025 National Research InstituteLos Angeles, California, United States, 90057 Harbor - Ucla Medical CenterTorrance, California, United States, 90509-2910|Newark, Delaware, United States, 10713|Aventura, Florida, United States, 33180 South Florida Medical ResearchAventura, Florida, United States, 33180 Helix Biomedics, LlcBoynton Beach, Florida, United States, 33436 Dr. Victoria Garcia & Associates, Llc Doral Medical ResearchDoral, Florida, United States, 33166 Sweet Hope Research Specialty, Inc.Hialeah, Florida, United States, 33016 Clinical Neurosciences Solutions, Inc. Dba Cns HealthcareJacksonville, Florida, United States, 32256 Altus ResearchLake Worth, Florida, United States, 33461 Axcess Medical Research, LlcLoxahatchee Groves, Florida, United States, 33470 Ocean Blue Medical Research Center, Inc.Miami Springs, Florida, United States, 33166 Serenity Holistic ObgynMiami, Florida, United States, 33181 Compass Research, LlcOrlando, Florida, United States, 32806 Discovery Clinical ResearchPlantation, Florida, United States, 33324 Oncova Clinical Research, Inc.Saint Cloud, Florida, United States, 34769|Chicago, Illinois, United States, 60612|Shawnee Mission, Kansas, United States, 66218|Shreveport, Louisiana, United States, 71118|Baltimore, Maryland, United States, 21208 Simmonds, Martin And HelmbrechtGaithersburg, Maryland, United States, 20878 Advantia Health, Llc Obstetrics & Gynecology Assoc.Silver Spring, Maryland, United States, 20910|Brooklyn, New York, United States, 11203|Charlotte, North Carolina, United States, 28204 Unified Women'S Clinical Research - Morehead CityMorehead City, North Carolina, United States, 28557 Eastern Carolina Women'S CenterNew Bern, North Carolina, United States, 28562 Wake Research AsssociatesRaleigh, North Carolina, United States, 27612|Bryn Mawr, Pennsylvania, United States, 19010 Clinical Research Of Philadelphia, LlcPhiladelphia, Pennsylvania, United States, 19114|Bluffton, South Carolina, United States, 29910 Medical University Of South CarolinaCharleston, South Carolina, United States, 29425 Fusion Clinical Research Of Spartanburg, LlcSpartanburg, South Carolina, United States, 29301|Chattanooga, Tennessee, United States, 37404 Clinical Neurosciences Solutions, Inc Dba Cns HealthcareMemphis, Tennessee, United States, 38119 Paramount Research SolutionsNashville, Tennessee, United States, 37203|Fort Worth, Texas, United States, 76104 Willowbend Health & Wellness AssociatesFrisco, Texas, United States, 75035 Family Medicine ClinicGeorgetown, Texas, United States, 78626 Biopharma Informatic, Inc.Houston, Texas, United States, 77043 Centex Studies, Inc.Houston, Texas, United States, 77058 The Center For Clinical Trials, Inc.Houston, Texas, United States, 77082 Houston Center For Clinical Research, LlcSugar Land, Texas, United States, 77479|Arlington, Virginia, United States, 22207 Inova Fairfax HospitalFalls Church, Virginia, United States, 22042 Synexus Research, LlcRichmond, Virginia, United States, 23226","Alabama|California|Delaware|Florida|Illinois|Kansas|Louisiana|Maryland|New York|North Carolina|Pennsylvania|South Carolina|Tennessee|Texas|Virginia","Bulgaria|China|Czechia|Georgia|Israel|New Zealand|South Africa|United States","Multiprofile Hospital For Active Treatment-Dr. T. Venkova Ad|Beijing Hospital Of Traditional Chinese Medicine|Fujian Fuzhou General Hospital Of Nanjing Military Command|Gansu Lanzhou University Second Hospital|Guangdong Guangzhou Women And Children's Medical Center|Guangxi The People's Hospital Of Guangxi Zhuang Autonomous Region|Hainan Hainan General Hospital|Hebei The 2Nd Hospital Of Hebei Medical University|Hubei Center For Reproductive Medicine,Tongji Medical College,Hust|Jiangsu Nanjing Maternity And Child Health Care Hospital|Jiangxi Jiangxi Maternal And Child Health Hospital|Jilin The Second Hospital Of Jilin University|Liaoning The First Affiliated Hospital Of Dalian Medical University|Medical University|Ningxia General Hospital Of Ningxia Medical University|Second University Hospital|Shaanxi 1St Affiliated Hospital Of Xi'An Jiaotong Medical University|Shaanxi Second Affiliated Hospital Xian Jiaotong University School|Shanxi The Second Affiliated Hospital Of Shanxi Medical University|Xinjiang The First Affiliated Hospital Of Xinjiang Medical University|Zhejiang Women's Hospital School Of Medicine Zhejiang University|Gynekologie Meda S.R.O.|Center For Women|Haemek Medical Center|P3 Research Ltd Hawkes Bay|, Gauteng Wits Clinical Research Site|, Kwazulu-Natal Umhlanga Medical Centre|University Of Alabama At Birmingham|California Center For Clinical Research|Christiana Care Health System|Ideal Clinical Research|University Of Illinois At Chicago|Gtc Research|Omni Fertility And Laser Institute|Pharmasite Research, Inc.|Suny Downstate Medical Center|Carolinas Healthcare System|Main Line Fertility Center|Fellows Research Alliance, Inc.|Chattanooga Medical Research, Llc|Texas Health Care, Pllc|Millennium Clinical Trials, Llc",{"$nulls":3},"Bayer Study Director","2019-01-09","2020-05-25T16:37:11.001","2020-05-26T17:10:42.972","NCT03400943"]
["5ecbf43611702c1b1b916a96","NCT03400943","2019-02-05","Bayer","BAYN","Active, not recruiting","Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 3)","Bay-1002670|Vilaprisan","PR Modulator","Yes","['Bay-1002670', 'Vilaprisan']","No",null,"Phase 3",4,260,"Anticipated","2018-01-17","2020-05-20",{"$nulls":5},"The primary objective of this study is to show superiority in the treatment of HMB of vilaprisan in subjects with uterine fibroids compared to placebo.\n\nThe secondary objectives of this study are to additionally evaluate the efficacy and safety of vilaprisan in subjects with uterine fibroids.",null,"A Randomized, Parallel-group, Double-blind and Open-label Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Vilaprisan in Subjects With Uterine Fibroids",15787,"Leiomyoma","Leiomyoma|Myoma","Oncology Solid Tumor","Oncology","Experimental","Vilaprisan_A1|Vilaprisan_A2|Vilaprisan_B1|Vilaprisan_B2","vilaprisan (2 mg), 2 treatment periods of 12 weeks, separated by 1 bleeding episode|vilaprisan (2 mg), 2 treatment periods of 12 weeks without a break|placebo, 1 treatment period of 12 weeks, and vilaprisan (2 mg), 1 treatment period of 12 weeks, separated by 1 bleeding episode|vilaprisan (2 mg), 1 treatment period of 12 weeks, and placebo, 1 treatment period of 12 weeks, separated by 1 bleeding episode","Drug","Vilaprisan (BAY1002670)|Placebo","2 mg of Vilaprisan once daily up to 2 x 12 weeks|Matching placebo is administered to group B1 and B2.",null,"Vilaprisan_A1|Vilaprisan_A2|Vilaprisan_B1|Vilaprisan_B2","\n\n * Women, 18 years or older in good General health\n * Diagnosis of uterine fibroid(s) documented by ultrasound at screening with at least 1 fibroid with largest Diameter â‰¥ 30 mm and < 120 mm\n * Heavy menstrual bleeding (HMB) in at least 2 bleeding periods during the Screening period each with blood loss volume of >80.00 mL documented by alkaline hematin (AH) method\n * An endometrial biopsy performed during the Screening period without significant histological disorder such as endometrial hyperplasia (including simple hyperplasia) or other significant endometrial pathology\n * Use of an acceptable non-hormonal method of contraception (ie, either male condom, cap, diaphragm or sponge, each in combination with spermicide) starting at Visit 1 until the end of the study\n\n","\n\n * Pregnancy or lactation (less than 3 month since delivery, abortion, or lactation before start of Treatment)\n * Hypersensitivity to any ingredient of the study drug\n * Any condition requiring immediate blood transfusion\n * Laboratory values outside inclusion range before randomization and considered as clinically relevant.\n * Any diseases, conditions, or medications that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study drug\n * Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results\n * Abuse of alcohol, drugs, or medicines (eg, laxatives)\n * Use of other treatments that might interfere with the conduct of the study or the interpretation of the results\n * Undiagnosed abnormal genital bleeding",{"$nulls":4},"Actual","2018-01-17","Actual","Anticipated","2020-05-20","Anticipated","2019-02-01","2018-01-05","2018-01-15","2019-02-02","No","Uterine fibroids\nHeavy menstrual bleeding","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"Female",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"2017-002997-38","EudraCT Number","Amenorrhea (yes/no)","Amenorrhea (yes/no), defined as MBL <2 mL during the last 28 days of treatment.","The last 28 days of treatment period 1 and treatment period 2","Heavy Menstrual Bleeding (HMB) response|Time to onset of amenorrhea|Time to onset of controlled bleeding|Absence of bleeding (spotting allowed)|Endometrial histology|Endometrial thickness","HMB response defined as blood loss <80.00 mL during the last 28 days of treatment and >50% reduction compared to baseline|Onset of amenorrhea is defined by the first day for which the menstrual blood loss for all subsequent 28-day periods up to the end of the treatment period is <2 mL|By Uterine Fibroid Daily Bleeding Diary (UF-DBD)|Benign endometrium, presence or absence of hyperplasia or malignancy|Up to 36 weeks","The last 28 days of treatment period 1 and treatment period 2|In treatment period 1 (12 weeks) and in treatment period 2 (12 weeks)|Up to 36 weeks",{"$nulls":3},"Gabrovo, Bulgaria, 5300 Hospital For Active Treatment - Prof.Paraskev Stoyanov AdLovech, Bulgaria, 5500 Mhat Dr. Bratan Shukerov AdSmolyan, Bulgaria, 4700 Mhat For Women'S Health - Nadezhda OodSofia, Bulgaria, 1330|Beijing, China, 100010 Peking University First HospitalBeijing, China, 100034 Beijing Friendship Hospital, Capital Medical UniversityBeijing, China, 100050 Beijing Tiantan Hospital, Captial Medical UniversityBeijing, China, 100050 Beijing Luhe Hospital Of Capital Medicial UniversityBeijing, China, 101199 Shanghai East Hospital Affiated To Tongji UniversityShanghai, China, 200123 Tianjin Medical University General HospitalTianjin, China, 300052 Tianjin Central Hospital Of Gynecology ObstetricsTianjin, China, 300199|Fuzhou, Fujian, China, 350025|Lanzhou, Gansu, China, 730030|Guangzhou, Guangdong, China, 510623 The Third Affiliated Hospital, Sun Yat-Sen UniversityGuangzhou, Guangdong, China, 510630 Boai Hospital Of ZhongshanZhongshan, Guangdong, China|Nanning, Guangxi, China, 530021|Haikou, Hainan, China, 570311|Shijiazhuang, Hebei, China, 050000|Wuhan, Hubei, China, 430013|Nanjing, Jiangsu, China, 210004 Nanjing First HospitalNanjing, Jiangsu, China, 210006 Nj Drum Tower Hospital, The Affil Hos Of Nj Univ Med SchoolNanjing, Jiangsu, China, 210008 Zhongda Hospital Southeast UniversityNanjing, Jiangsu, China, 210009 The Second Affiliated Hospital Of Nanjing Medical UniversityNanjing, Jiangsu, China, 210011 1St Affiliated Hospital Of Soochow UniversitySuzhou, Jiangsu, China, 215006|Nanchang, Jiangxi, China, 330006 The Second Affiliated Hospital Of Nanchang UniversityNanchang, Jiangxi, China, 330006|Changchun, Jilin, China, 130000 The First Hospital Of Jilin UniversityChangchun, Jilin, China, 130021|Dalian, Liaoning, China, 116011 Shengjing Hospital Of|Shenyang, Liaoning, China, 110004|Yinchuan, Ningxia, China, 750004|Chengdu, Sichuan, China, 610041|Xi'An, Shaanxi, China, 710061|Xi'An, Shaanxi, China, 710004|Taiyuan, Shanxi, China, 030001|Urumqi, Xinjiang, China, 830054|Hangzhou, Zhejiang, China, 310006 Sir Run Run Shaw Hospital, Zhejiang Univ. School Of MedicineHangzhou, Zhejiang, China, 310016 The First Affiliated Hospital Of Wenzhou Medical Univ (New)Wenzhou, Zhejiang, China, 325000 The Second Affliated Hospital Of Wenzhou Medicial UniversityWenzhou, Zhejiang, China, 325000|Brno, Czechia, 602 00 Soukroma Gynekologicka AmbulanceFulnek, Czechia, 74245 Gynekologie Studentsky Dum S.R.O.Praha 6, Czechia, 160 00 Mudr. Ivana Salamonova S.R.O.Vysoke Myto, Czechia, 566 01|Atlanta, Georgia, United States, 30312 Agile Clinical Research Trials, LlcAtlanta, Georgia, United States, 30328 Atlanta Women'S Research Institute, Inc.Atlanta, Georgia, United States, 30342 Medisense, Inc.Atlanta, Georgia, United States, 30363 Paramount Research SolutionsCollege Park, Georgia, United States, 30349 Atlanta Gynecology Research InstitutePeachtree Corners, Georgia, United States, 30092 Fellows Research AllianceSavannah, Georgia, United States, 31406|Afula, Israel, 1834111 Hillel Yaffe Medical CenterHadera, Israel, 3810101 Rambam Health CorporationHaifa, Israel, 3109601 Lady Davis Carmel Medical CenterHaifa, Israel, 3436212 Meir Medical CenterKfar Saba, Israel, 4428164|Hawkes Bay, New Zealand, 4130 P3 ResearchTauranga, New Zealand, 3110|Johannesburg, Gauteng, South Africa, 2193 Dr L Reynders PracticeLyttelton Manor, Gauteng, South Africa, 0141 Wilgeheuwel HospitalRoodepoort, Gauteng, South Africa, 1724|Durban, Kwazulu-Natal, South Africa, 4319 Ethekwini Hospital & Heart CentreDurban, Kwazulu-Natal, South Africa|Birmingham, Alabama, United States, 35294-0026|Arcadia, California, United States, 91007 Core Healthcare GroupCerritos, California, United States, 90703 Aviva ResearchEscondido, California, United States, 92025 National Research InstituteLos Angeles, California, United States, 90057 Harbor - Ucla Medical CenterTorrance, California, United States, 90509-2910|Newark, Delaware, United States, 10713|Aventura, Florida, United States, 33180 South Florida Medical ResearchAventura, Florida, United States, 33180 Helix Biomedics, LlcBoynton Beach, Florida, United States, 33436 Dr. Victoria Garcia & Associates, Llc Doral Medical ResearchDoral, Florida, United States, 33166 Sweet Hope Research Specialty, Inc.Hialeah, Florida, United States, 33016 Clinical Neurosciences Solutions, Inc. Dba Cns HealthcareJacksonville, Florida, United States, 32256 Altus ResearchLake Worth, Florida, United States, 33461 Axcess Medical Research, LlcLoxahatchee Groves, Florida, United States, 33470 Ocean Blue Medical Research Center, Inc.Miami Springs, Florida, United States, 33166 Serenity Holistic ObgynMiami, Florida, United States, 33181 Compass Research, LlcOrlando, Florida, United States, 32806 Discovery Clinical ResearchPlantation, Florida, United States, 33324 Oncova Clinical Research, Inc.Saint Cloud, Florida, United States, 34769|Chicago, Illinois, United States, 60612|Shawnee Mission, Kansas, United States, 66218|Shreveport, Louisiana, United States, 71118|Baltimore, Maryland, United States, 21208 Simmonds, Martin And HelmbrechtGaithersburg, Maryland, United States, 20878 Advantia Health, Llc Obstetrics & Gynecology Assoc.Silver Spring, Maryland, United States, 20910|Brooklyn, New York, United States, 11203|Charlotte, North Carolina, United States, 28204 Unified Women'S Clinical Research - Morehead CityMorehead City, North Carolina, United States, 28557 Eastern Carolina Women'S CenterNew Bern, North Carolina, United States, 28562 Wake Research AsssociatesRaleigh, North Carolina, United States, 27612|Bryn Mawr, Pennsylvania, United States, 19010 Clinical Research Of Philadelphia, LlcPhiladelphia, Pennsylvania, United States, 19114|Bluffton, South Carolina, United States, 29910 Medical University Of South CarolinaCharleston, South Carolina, United States, 29425 Fusion Clinical Research Of Spartanburg, LlcSpartanburg, South Carolina, United States, 29301|Chattanooga, Tennessee, United States, 37404 Clinical Neurosciences Solutions, Inc Dba Cns HealthcareMemphis, Tennessee, United States, 38119 Paramount Research SolutionsNashville, Tennessee, United States, 37203|Fort Worth, Texas, United States, 76104 Willowbend Health & Wellness AssociatesFrisco, Texas, United States, 75035 Family Medicine ClinicGeorgetown, Texas, United States, 78626 Biopharma Informatic, Inc.Houston, Texas, United States, 77043 Centex Studies, Inc.Houston, Texas, United States, 77058 The Center For Clinical Trials, Inc.Houston, Texas, United States, 77082 Houston Center For Clinical Research, LlcSugar Land, Texas, United States, 77479|Arlington, Virginia, United States, 22207 Inova Fairfax HospitalFalls Church, Virginia, United States, 22042 Synexus Research, LlcRichmond, Virginia, United States, 23226","Alabama|California|Delaware|Florida|Illinois|Kansas|Louisiana|Maryland|New York|North Carolina|Pennsylvania|South Carolina|Tennessee|Texas|Virginia","Bulgaria|China|Czechia|Georgia|Israel|New Zealand|South Africa|United States","Multiprofile Hospital For Active Treatment-Dr. T. Venkova Ad|Beijing Hospital Of Traditional Chinese Medicine|Fujian Fuzhou General Hospital Of Nanjing Military Command|Gansu Lanzhou University Second Hospital|Guangdong Guangzhou Women And Children's Medical Center|Guangxi The People's Hospital Of Guangxi Zhuang Autonomous Region|Hainan Hainan General Hospital|Hebei The 2Nd Hospital Of Hebei Medical University|Hubei Center For Reproductive Medicine,Tongji Medical College,Hust|Jiangsu Nanjing Maternity And Child Health Care Hospital|Jiangxi Jiangxi Maternal And Child Health Hospital|Jilin The Second Hospital Of Jilin University|Liaoning The First Affiliated Hospital Of Dalian Medical University|Medical University|Ningxia General Hospital Of Ningxia Medical University|Second University Hospital|Shaanxi 1St Affiliated Hospital Of Xi'An Jiaotong Medical University|Shaanxi Second Affiliated Hospital Xian Jiaotong University School|Shanxi The Second Affiliated Hospital Of Shanxi Medical University|Xinjiang The First Affiliated Hospital Of Xinjiang Medical University|Zhejiang Women's Hospital School Of Medicine Zhejiang University|Gynekologie Meda S.R.O.|Center For Women|Haemek Medical Center|P3 Research Ltd Hawkes Bay|, Gauteng Wits Clinical Research Site|, Kwazulu-Natal Umhlanga Medical Centre|University Of Alabama At Birmingham|California Center For Clinical Research|Christiana Care Health System|Ideal Clinical Research|University Of Illinois At Chicago|Gtc Research|Omni Fertility And Laser Institute|Pharmasite Research, Inc.|Suny Downstate Medical Center|Carolinas Healthcare System|Main Line Fertility Center|Fellows Research Alliance, Inc.|Chattanooga Medical Research, Llc|Texas Health Care, Pllc|Millennium Clinical Trials, Llc",{"$nulls":3},"Bayer Study Director","2019-02-02","2020-05-25T16:37:10.410","2020-05-26T17:10:42.972","NCT03400943"]
["5ecbf436fe30261b1a048286","NCT03400943","2019-04-05","Bayer","BAYN","Active, not recruiting","Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 3)","Bay-1002670|Vilaprisan","PR Modulator","Yes","['Bay-1002670', 'Vilaprisan']","No",null,"Phase 3",4,260,"Anticipated","2018-01-17","2020-05-20",{"$nulls":5},"The primary objective of this study is to show superiority in the treatment of HMB of vilaprisan in subjects with uterine fibroids compared to placebo.\n\nThe secondary objectives of this study are to additionally evaluate the efficacy and safety of vilaprisan in subjects with uterine fibroids.",null,"A Randomized, Parallel-group, Double-blind and Open-label Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Vilaprisan in Subjects With Uterine Fibroids",15787,"Leiomyoma","Leiomyoma|Myoma","Oncology Solid Tumor","Oncology","Experimental","Vilaprisan_A1|Vilaprisan_A2|Vilaprisan_B1|Vilaprisan_B2","vilaprisan (2 mg), 2 treatment periods of 12 weeks, separated by 1 bleeding episode|vilaprisan (2 mg), 2 treatment periods of 12 weeks without a break|placebo, 1 treatment period of 12 weeks, and vilaprisan (2 mg), 1 treatment period of 12 weeks, separated by 1 bleeding episode|vilaprisan (2 mg), 1 treatment period of 12 weeks, and placebo, 1 treatment period of 12 weeks, separated by 1 bleeding episode","Drug","Vilaprisan (BAY1002670)|Placebo","2 mg of Vilaprisan once daily up to 2 x 12 weeks|Matching placebo is administered to group B1 and B2.",null,"Vilaprisan_A1|Vilaprisan_A2|Vilaprisan_B1|Vilaprisan_B2","\n\n * Women, 18 years or older in good General health\n * Diagnosis of uterine fibroid(s) documented by ultrasound at screening with at least 1 fibroid with largest Diameter â‰¥ 30 mm and < 120 mm\n * Heavy menstrual bleeding (HMB) in at least 2 bleeding periods during the Screening period each with blood loss volume of >80.00 mL documented by alkaline hematin (AH) method\n * An endometrial biopsy performed during the Screening period without significant histological disorder such as endometrial hyperplasia (including simple hyperplasia) or other significant endometrial pathology\n * Use of an acceptable non-hormonal method of contraception (ie, either male condom, cap, diaphragm or sponge, each in combination with spermicide) starting at Visit 1 until the end of the study\n\n","\n\n * Pregnancy or lactation (less than 3 month since delivery, abortion, or lactation before start of Treatment)\n * Hypersensitivity to any ingredient of the study drug\n * Any condition requiring immediate blood transfusion\n * Laboratory values outside inclusion range before randomization and considered as clinically relevant.\n * Any diseases, conditions, or medications that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study drug\n * Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results\n * Abuse of alcohol, drugs, or medicines (eg, laxatives)\n * Use of other treatments that might interfere with the conduct of the study or the interpretation of the results\n * Undiagnosed abnormal genital bleeding",{"$nulls":4},"Actual","2018-01-17","Actual","Anticipated","2020-05-20","Anticipated","2019-04-01","2018-01-05","2018-01-15","2019-04-04","No","Uterine fibroids\nHeavy menstrual bleeding","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"Female",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"2017-002997-38","EudraCT Number","Amenorrhea (yes/no)","Amenorrhea (yes/no), defined as MBL <2 mL during the last 28 days of treatment.","The last 28 days of treatment period 1 and treatment period 2","Heavy Menstrual Bleeding (HMB) response|Time to onset of amenorrhea|Time to onset of controlled bleeding|Absence of bleeding (spotting allowed)|Endometrial histology|Endometrial thickness","HMB response defined as blood loss <80.00 mL during the last 28 days of treatment and >50% reduction compared to baseline|Onset of amenorrhea is defined by the first day for which the menstrual blood loss for all subsequent 28-day periods up to the end of the treatment period is <2 mL|By Uterine Fibroid Daily Bleeding Diary (UF-DBD)|Benign endometrium, presence or absence of hyperplasia or malignancy|Up to 36 weeks","The last 28 days of treatment period 1 and treatment period 2|In treatment period 1 (12 weeks) and in treatment period 2 (12 weeks)|Up to 36 weeks",{"$nulls":3},"Gabrovo, Bulgaria, 5300 Hospital For Active Treatment - Prof.Paraskev Stoyanov AdLovech, Bulgaria, 5500 Mhat Dr. Bratan Shukerov AdSmolyan, Bulgaria, 4700 Mhat For Women'S Health - Nadezhda OodSofia, Bulgaria, 1330|Beijing, China, 100010 Peking University First HospitalBeijing, China, 100034 Beijing Friendship Hospital, Capital Medical UniversityBeijing, China, 100050 Beijing Tiantan Hospital, Captial Medical UniversityBeijing, China, 100050 Beijing Luhe Hospital Of Capital Medicial UniversityBeijing, China, 101199 Shanghai East Hospital Affiated To Tongji UniversityShanghai, China, 200123 Tianjin Medical University General HospitalTianjin, China, 300052 Tianjin Central Hospital Of Gynecology ObstetricsTianjin, China, 300199|Fuzhou, Fujian, China, 350025|Lanzhou, Gansu, China, 730030|Guangzhou, Guangdong, China, 510623 The Third Affiliated Hospital, Sun Yat-Sen UniversityGuangzhou, Guangdong, China, 510630 Boai Hospital Of ZhongshanZhongshan, Guangdong, China|Nanning, Guangxi, China, 530021|Haikou, Hainan, China, 570311|Shijiazhuang, Hebei, China, 050000|Wuhan, Hubei, China, 430013|Nanjing, Jiangsu, China, 210004 Nanjing First HospitalNanjing, Jiangsu, China, 210006 Nj Drum Tower Hospital, The Affil Hos Of Nj Univ Med SchoolNanjing, Jiangsu, China, 210008 Zhongda Hospital Southeast UniversityNanjing, Jiangsu, China, 210009 The Second Affiliated Hospital Of Nanjing Medical UniversityNanjing, Jiangsu, China, 210011 1St Affiliated Hospital Of Soochow UniversitySuzhou, Jiangsu, China, 215006|Nanchang, Jiangxi, China, 330006 The Second Affiliated Hospital Of Nanchang UniversityNanchang, Jiangxi, China, 330006|Changchun, Jilin, China, 130000 The First Hospital Of Jilin UniversityChangchun, Jilin, China, 130021|Dalian, Liaoning, China, 116011 Shengjing Hospital Of|Shenyang, Liaoning, China, 110004|Yinchuan, Ningxia, China, 750004|Chengdu, Sichuan, China, 610041|Xi'An, Shaanxi, China, 710061|Xi'An, Shaanxi, China, 710004|Taiyuan, Shanxi, China, 030001|Urumqi, Xinjiang, China, 830054|Hangzhou, Zhejiang, China, 310006 Sir Run Run Shaw Hospital, Zhejiang Univ. School Of MedicineHangzhou, Zhejiang, China, 310016 The First Affiliated Hospital Of Wenzhou Medical Univ (New)Wenzhou, Zhejiang, China, 325000 The Second Affliated Hospital Of Wenzhou Medicial UniversityWenzhou, Zhejiang, China, 325000|Brno, Czechia, 602 00 Soukroma Gynekologicka AmbulanceFulnek, Czechia, 74245 Gynekologie Studentsky Dum S.R.O.Praha 6, Czechia, 160 00 Mudr. Ivana Salamonova S.R.O.Vysoke Myto, Czechia, 566 01|Atlanta, Georgia, United States, 30312 Agile Clinical Research Trials, LlcAtlanta, Georgia, United States, 30328 Atlanta Women'S Research Institute, Inc.Atlanta, Georgia, United States, 30342 Medisense, Inc.Atlanta, Georgia, United States, 30363 Paramount Research SolutionsCollege Park, Georgia, United States, 30349 Atlanta Gynecology Research InstitutePeachtree Corners, Georgia, United States, 30092 Fellows Research AllianceSavannah, Georgia, United States, 31406|Afula, Israel, 1834111 Hillel Yaffe Medical CenterHadera, Israel, 3810101 Rambam Health CorporationHaifa, Israel, 3109601 Lady Davis Carmel Medical CenterHaifa, Israel, 3436212 Meir Medical CenterKfar Saba, Israel, 4428164|Hawkes Bay, New Zealand, 4130 P3 ResearchTauranga, New Zealand, 3110|Johannesburg, Gauteng, South Africa, 2193 Dr L Reynders PracticeLyttelton Manor, Gauteng, South Africa, 0141 Wilgeheuwel HospitalRoodepoort, Gauteng, South Africa, 1724|Durban, Kwazulu-Natal, South Africa, 4319 Ethekwini Hospital & Heart CentreDurban, Kwazulu-Natal, South Africa|Birmingham, Alabama, United States, 35294-0026|Arcadia, California, United States, 91007 Core Healthcare GroupCerritos, California, United States, 90703 Aviva ResearchEscondido, California, United States, 92025 National Research InstituteLos Angeles, California, United States, 90057 Harbor - Ucla Medical CenterTorrance, California, United States, 90509-2910|Aventura, Florida, United States, 33180 South Florida Medical ResearchAventura, Florida, United States, 33180 Helix Biomedics, LlcBoynton Beach, Florida, United States, 33436 Dr. Victoria Garcia & Associates, Llc Doral Medical ResearchDoral, Florida, United States, 33166 Sweet Hope Research Specialty, Inc.Hialeah, Florida, United States, 33016 Clinical Neurosciences Solutions, Inc. Dba Cns HealthcareJacksonville, Florida, United States, 32256 Altus ResearchLake Worth, Florida, United States, 33461 Axcess Medical Research, LlcLoxahatchee Groves, Florida, United States, 33470 Ocean Blue Medical Research Center, Inc.Miami Springs, Florida, United States, 33166 Serenity Holistic ObgynMiami, Florida, United States, 33181 Compass Research, LlcOrlando, Florida, United States, 32806 Discovery Clinical ResearchPlantation, Florida, United States, 33324 Oncova Clinical Research, Inc.Saint Cloud, Florida, United States, 34769|Chicago, Illinois, United States, 60612|Shawnee Mission, Kansas, United States, 66218|Shreveport, Louisiana, United States, 71118|Baltimore, Maryland, United States, 21208 Simmonds, Martin And HelmbrechtGaithersburg, Maryland, United States, 20878 Advantia Health, Llc Obstetrics & Gynecology Assoc.Silver Spring, Maryland, United States, 20910|Brooklyn, New York, United States, 11203|Charlotte, North Carolina, United States, 28204 Unified Women'S Clinical Research - Morehead CityMorehead City, North Carolina, United States, 28557 Eastern Carolina Women'S CenterNew Bern, North Carolina, United States, 28562 Wake Research AsssociatesRaleigh, North Carolina, United States, 27612|Bryn Mawr, Pennsylvania, United States, 19010 Clinical Research Of Philadelphia, LlcPhiladelphia, Pennsylvania, United States, 19114|Bluffton, South Carolina, United States, 29910 Medical University Of South CarolinaCharleston, South Carolina, United States, 29425 Fusion Clinical Research Of Spartanburg, LlcSpartanburg, South Carolina, United States, 29301|Chattanooga, Tennessee, United States, 37404 Clinical Neurosciences Solutions, Inc Dba Cns HealthcareMemphis, Tennessee, United States, 38119 Paramount Research SolutionsNashville, Tennessee, United States, 37203|Fort Worth, Texas, United States, 76104 Willowbend Health & Wellness AssociatesFrisco, Texas, United States, 75035 Family Medicine ClinicGeorgetown, Texas, United States, 78626 Biopharma Informatic, Inc.Houston, Texas, United States, 77043 Centex Studies, Inc.Houston, Texas, United States, 77058 The Center For Clinical Trials, Inc.Houston, Texas, United States, 77082 Houston Center For Clinical Research, LlcSugar Land, Texas, United States, 77479|Arlington, Virginia, United States, 22207 Inova Fairfax HospitalFalls Church, Virginia, United States, 22042 Synexus Research, LlcRichmond, Virginia, United States, 23226","Alabama|California|Florida|Illinois|Kansas|Louisiana|Maryland|New York|North Carolina|Pennsylvania|South Carolina|Tennessee|Texas|Virginia","Bulgaria|China|Czechia|Georgia|Israel|New Zealand|South Africa|United States","Multiprofile Hospital For Active Treatment-Dr. T. Venkova Ad|Beijing Hospital Of Traditional Chinese Medicine|Fujian Fuzhou General Hospital Of Nanjing Military Command|Gansu Lanzhou University Second Hospital|Guangdong Guangzhou Women And Children's Medical Center|Guangxi The People's Hospital Of Guangxi Zhuang Autonomous Region|Hainan Hainan General Hospital|Hebei The 2Nd Hospital Of Hebei Medical University|Hubei Center For Reproductive Medicine,Tongji Medical College,Hust|Jiangsu Nanjing Maternity And Child Health Care Hospital|Jiangxi Jiangxi Maternal And Child Health Hospital|Jilin The Second Hospital Of Jilin University|Liaoning The First Affiliated Hospital Of Dalian Medical University|Medical University|Ningxia General Hospital Of Ningxia Medical University|Second University Hospital|Shaanxi 1St Affiliated Hospital Of Xi'An Jiaotong Medical University|Shaanxi Second Affiliated Hospital Xian Jiaotong University School|Shanxi The Second Affiliated Hospital Of Shanxi Medical University|Xinjiang The First Affiliated Hospital Of Xinjiang Medical University|Zhejiang Women's Hospital School Of Medicine Zhejiang University|Gynekologie Meda S.R.O.|Center For Women|Haemek Medical Center|P3 Research Ltd Hawkes Bay|, Gauteng Wits Clinical Research Site|, Kwazulu-Natal Umhlanga Medical Centre|University Of Alabama At Birmingham|California Center For Clinical Research|Ideal Clinical Research|University Of Illinois At Chicago|Gtc Research|Omni Fertility And Laser Institute|Pharmasite Research, Inc.|Suny Downstate Medical Center|Carolinas Healthcare System|Main Line Fertility Center|Fellows Research Alliance, Inc.|Chattanooga Medical Research, Llc|Texas Health Care, Pllc|Millennium Clinical Trials, Llc",{"$nulls":3},"Bayer Study Director","2019-04-04","2020-05-25T16:37:10.843","2020-05-26T17:10:42.972","NCT03400943"]
["5ecbf437e2561b1b11905d82","NCT03400943","2019-07-18","Bayer","BAYN","Active, not recruiting","Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 3)","Bay-1002670|Vilaprisan","PR Modulator","Yes","['Bay-1002670', 'Vilaprisan']","No",null,"Phase 3",4,260,"Anticipated","2018-01-17","2020-05-20",{"$nulls":5},"The primary objective of this study is to show superiority in the treatment of HMB of vilaprisan in subjects with uterine fibroids compared to placebo.\n\nThe secondary objectives of this study are to additionally evaluate the efficacy and safety of vilaprisan in subjects with uterine fibroids.",null,"A Randomized, Parallel-group, Double-blind and Open-label Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Vilaprisan in Subjects With Uterine Fibroids",15787,"Leiomyoma","Leiomyoma|Myoma","Oncology Solid Tumor","Oncology","Experimental","Vilaprisan_A1|Vilaprisan_A2|Vilaprisan_B1|Vilaprisan_B2","vilaprisan (2 mg), 2 treatment periods of 12 weeks, separated by 1 bleeding episode|vilaprisan (2 mg), 2 treatment periods of 12 weeks without a break|placebo, 1 treatment period of 12 weeks, and vilaprisan (2 mg), 1 treatment period of 12 weeks, separated by 1 bleeding episode|vilaprisan (2 mg), 1 treatment period of 12 weeks, and placebo, 1 treatment period of 12 weeks, separated by 1 bleeding episode","Drug","Vilaprisan (BAY1002670)|Placebo","2 mg of Vilaprisan once daily up to 2 x 12 weeks|Matching placebo is administered to group B1 and B2.",null,"Vilaprisan_A1|Vilaprisan_A2|Vilaprisan_B1|Vilaprisan_B2","\n\n * Women, 18 years or older in good General health\n * Diagnosis of uterine fibroid(s) documented by ultrasound at screening with at least 1 fibroid with largest Diameter â‰¥ 30 mm and < 120 mm\n * Heavy menstrual bleeding (HMB) in at least 2 bleeding periods during the Screening period each with blood loss volume of >80.00 mL documented by alkaline hematin (AH) method\n * An endometrial biopsy performed during the Screening period without significant histological disorder such as endometrial hyperplasia (including simple hyperplasia) or other significant endometrial pathology\n * Use of an acceptable non-hormonal method of contraception (ie, either male condom, cap, diaphragm or sponge, each in combination with spermicide) starting at Visit 1 until the end of the study\n\n","\n\n * Pregnancy or lactation (less than 3 month since delivery, abortion, or lactation before start of Treatment)\n * Hypersensitivity to any ingredient of the study drug\n * Any condition requiring immediate blood transfusion\n * Laboratory values outside inclusion range before randomization and considered as clinically relevant.\n * Any diseases, conditions, or medications that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study drug\n * Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results\n * Abuse of alcohol, drugs, or medicines (eg, laxatives)\n * Use of other treatments that might interfere with the conduct of the study or the interpretation of the results\n * Undiagnosed abnormal genital bleeding",{"$nulls":4},"Actual","2018-01-17","Actual","Anticipated","2020-05-20","Anticipated","2019-07-01","2018-01-05","2018-01-15","2019-07-17","No","Uterine fibroids\nHeavy menstrual bleeding","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"Female",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"2017-002997-38","EudraCT Number","Amenorrhea (yes/no)","Amenorrhea (yes/no), defined as MBL <2 mL during the last 28 days of treatment","The last 28 days of treatment period 1 and treatment period 2","Heavy Menstrual Bleeding (HMB) response|Time to onset of amenorrhea|Time to onset of controlled bleeding|Absence of bleeding (spotting allowed)|Endometrial histology|Endometrial thickness","HMB response defined as blood loss <80.00 mL during the last 28 days of treatment and >50% reduction compared to baseline|Onset of amenorrhea is defined by the first day for which the menstrual blood loss for all subsequent 28-day periods up to the end of the treatment period is <2 mL|By Uterine Fibroid Daily Bleeding Diary (UF-DBD)|Benign endometrium, presence or absence of hyperplasia or malignancy|Up to 36 weeks","The last 28 days of treatment period 1 and treatment period 2|In treatment period 1 (12 weeks) and in treatment period 2 (12 weeks)|Up to 36 weeks",{"$nulls":3},"Gabrovo, Bulgaria, 5300 Hospital For Active Treatment - Prof.Paraskev Stoyanov AdLovech, Bulgaria, 5500 Mhat Dr. Bratan Shukerov AdSmolyan, Bulgaria, 4700 Mhat For Women'S Health - Nadezhda OodSofia, Bulgaria, 1330|Beijing, China, 100010 Peking University First HospitalBeijing, China, 100034 Beijing Friendship Hospital, Capital Medical UniversityBeijing, China, 100050 Beijing Tiantan Hospital, Captial Medical UniversityBeijing, China, 100050 Beijing Luhe Hospital Of Capital Medicial UniversityBeijing, China, 101199 Shanghai East Hospital Affiated To Tongji UniversityShanghai, China, 200123 Tianjin Medical University General HospitalTianjin, China, 300052 Tianjin Central Hospital Of Gynecology ObstetricsTianjin, China, 300199|Fuzhou, Fujian, China, 350025|Lanzhou, Gansu, China, 730030|Guangzhou, Guangdong, China, 510623 The Third Affiliated Hospital, Sun Yat-Sen UniversityGuangzhou, Guangdong, China, 510630 Boai Hospital Of ZhongshanZhongshan, Guangdong, China|Nanning, Guangxi, China, 530021|Haikou, Hainan, China, 570311|Shijiazhuang, Hebei, China, 050000|Wuhan, Hubei, China, 430013|Nanjing, Jiangsu, China, 210004 Nanjing First HospitalNanjing, Jiangsu, China, 210006 Nj Drum Tower Hospital, The Affil Hos Of Nj Univ Med SchoolNanjing, Jiangsu, China, 210008 Zhongda Hospital Southeast UniversityNanjing, Jiangsu, China, 210009 The Second Affiliated Hospital Of Nanjing Medical UniversityNanjing, Jiangsu, China, 210011 1St Affiliated Hospital Of Soochow UniversitySuzhou, Jiangsu, China, 215006|Nanchang, Jiangxi, China, 330006 The Second Affiliated Hospital Of Nanchang UniversityNanchang, Jiangxi, China, 330006|Changchun, Jilin, China, 130000 The First Hospital Of Jilin UniversityChangchun, Jilin, China, 130021|Dalian, Liaoning, China, 116011 Shengjing Hospital Of|Shenyang, Liaoning, China, 110004|Yinchuan, Ningxia, China, 750004|Chengdu, Sichuan, China, 610041|Xi'An, Shaanxi, China, 710061|Xi'An, Shaanxi, China, 710004|Taiyuan, Shanxi, China, 030001|Urumqi, Xinjiang, China, 830054|Hangzhou, Zhejiang, China, 310006 Sir Run Run Shaw Hospital, Zhejiang Univ. School Of MedicineHangzhou, Zhejiang, China, 310016 The First Affiliated Hospital Of Wenzhou Medical Univ (New)Wenzhou, Zhejiang, China, 325000 The Second Affliated Hospital Of Wenzhou Medicial UniversityWenzhou, Zhejiang, China, 325000|Brno, Czechia, 602 00 Soukroma Gynekologicka AmbulanceFulnek, Czechia, 74245 Gynekologie Studentsky Dum S.R.O.Praha 6, Czechia, 160 00 Mudr. Ivana Salamonova S.R.O.Vysoke Myto, Czechia, 566 01|Atlanta, Georgia, United States, 30312 Agile Clinical Research Trials, LlcAtlanta, Georgia, United States, 30328 Atlanta Women'S Research Institute, Inc.Atlanta, Georgia, United States, 30342 Medisense, Inc.Atlanta, Georgia, United States, 30363 Paramount Research SolutionsCollege Park, Georgia, United States, 30349 Atlanta Gynecology Research InstitutePeachtree Corners, Georgia, United States, 30092 Fellows Research AllianceSavannah, Georgia, United States, 31406|Afula, Israel, 1834111 Hillel Yaffe Medical CenterHadera, Israel, 3810101 Rambam Health CorporationHaifa, Israel, 3109601 Lady Davis Carmel Medical CenterHaifa, Israel, 3436212 Meir Medical CenterKfar Saba, Israel, 4428164|Hawkes Bay, New Zealand, 4130 P3 ResearchTauranga, New Zealand, 3110|Johannesburg, Gauteng, South Africa, 2193 Dr L Reynders PracticeLyttelton Manor, Gauteng, South Africa, 0141 Wilgeheuwel HospitalRoodepoort, Gauteng, South Africa, 1724|Durban, Kwazulu-Natal, South Africa, 4319 Ethekwini Hospital & Heart CentreDurban, Kwazulu-Natal, South Africa|Birmingham, Alabama, United States, 35294-0026|Arcadia, California, United States, 91007 Core Healthcare GroupCerritos, California, United States, 90703 Aviva ResearchEscondido, California, United States, 92025 National Research InstituteLos Angeles, California, United States, 90057 Harbor - Ucla Medical CenterTorrance, California, United States, 90509-2910|Aventura, Florida, United States, 33180 South Florida Medical ResearchAventura, Florida, United States, 33180 Helix Biomedics, LlcBoynton Beach, Florida, United States, 33435 Dr. Victoria Garcia & Associates, Llc Doral Medical ResearchDoral, Florida, United States, 33166 Sweet Hope Research Specialty, Inc.Hialeah, Florida, United States, 33016 Clinical Neurosciences Solutions, Inc. Dba Cns HealthcareJacksonville, Florida, United States, 32256 Altus ResearchLake Worth, Florida, United States, 33461 Axcess Medical Research, LlcLoxahatchee Groves, Florida, United States, 33470 Ocean Blue Medical Research Center, Inc.Miami Springs, Florida, United States, 33166 Serenity Holistic ObgynMiami, Florida, United States, 33181 Compass Research, LlcOrlando, Florida, United States, 32806 Discovery Clinical ResearchPlantation, Florida, United States, 33324 Oncova Clinical Research, Inc.Saint Cloud, Florida, United States, 34769|Chicago, Illinois, United States, 60612|Shawnee Mission, Kansas, United States, 66218|Shreveport, Louisiana, United States, 71118|Baltimore, Maryland, United States, 21208 Simmonds, Martin And HelmbrechtGaithersburg, Maryland, United States, 20878 Advantia Health, Llc Obstetrics & Gynecology Assoc.Silver Spring, Maryland, United States, 20910|Brooklyn, New York, United States, 11203|Charlotte, North Carolina, United States, 28204 Unified Women'S Clinical Research - Morehead CityMorehead City, North Carolina, United States, 28557 Eastern Carolina Women'S CenterNew Bern, North Carolina, United States, 28562 Wake Research AssociatesRaleigh, North Carolina, United States, 27612|Bryn Mawr, Pennsylvania, United States, 19010 Clinical Research Of Philadelphia, LlcPhiladelphia, Pennsylvania, United States, 19114|Bluffton, South Carolina, United States, 29910 Medical University Of South CarolinaCharleston, South Carolina, United States, 29425 Fusion Clinical Research Of Spartanburg, LlcSpartanburg, South Carolina, United States, 29301|Chattanooga, Tennessee, United States, 37404 Clinical Neurosciences Solutions, Inc Dba Cns HealthcareMemphis, Tennessee, United States, 38119 Paramount Research SolutionsNashville, Tennessee, United States, 37203|Fort Worth, Texas, United States, 76104 Willowbend Health & Wellness AssociatesFrisco, Texas, United States, 75035 Family Medicine ClinicGeorgetown, Texas, United States, 78626 Biopharma Informatic, Inc.Houston, Texas, United States, 77043 Centex Studies, Inc.Houston, Texas, United States, 77058 The Center For Clinical Trials, Inc.Houston, Texas, United States, 77082 Houston Center For Clinical Research, LlcSugar Land, Texas, United States, 77479|Arlington, Virginia, United States, 22207 Inova Fairfax HospitalFalls Church, Virginia, United States, 22042 Synexus Research, LlcRichmond, Virginia, United States, 23226","Alabama|California|Florida|Illinois|Kansas|Louisiana|Maryland|New York|North Carolina|Pennsylvania|South Carolina|Tennessee|Texas|Virginia","Bulgaria|China|Czechia|Georgia|Israel|New Zealand|South Africa|United States","Multiprofile Hospital For Active Treatment-Dr. T. Venkova Ad|Beijing Hospital Of Traditional Chinese Medicine|Fujian Fuzhou General Hospital Of Nanjing Military Command|Gansu Lanzhou University Second Hospital|Guangdong Guangzhou Women And Children's Medical Center|Guangxi The People's Hospital Of Guangxi Zhuang Autonomous Region|Hainan Hainan General Hospital|Hebei The 2Nd Hospital Of Hebei Medical University|Hubei Center For Reproductive Medicine,Tongji Medical College,Hust|Jiangsu Nanjing Maternity And Child Health Care Hospital|Jiangxi Jiangxi Maternal And Child Health Hospital|Jilin The Second Hospital Of Jilin University|Liaoning The First Affiliated Hospital Of Dalian Medical University|Medical University|Ningxia General Hospital Of Ningxia Medical University|Second University Hospital|Shaanxi 1St Affiliated Hospital Of Xi'An Jiaotong Medical University|Shaanxi Second Affiliated Hospital Xian Jiaotong University School|Shanxi The Second Affiliated Hospital Of Shanxi Medical University|Xinjiang The First Affiliated Hospital Of Xinjiang Medical University|Zhejiang Women's Hospital School Of Medicine Zhejiang University|Gynekologie Meda S.R.O.|Center For Women|Haemek Medical Center|P3 Research Ltd Hawkes Bay|, Gauteng Wits Clinical Research Site|, Kwazulu-Natal Umhlanga Medical Centre|University Of Alabama At Birmingham|California Center For Clinical Research|Ideal Clinical Research|University Of Illinois At Chicago|Gtc Research|Omni Fertility And Laser Institute|Pharmasite Research, Inc.|Suny Downstate Medical Center|Carolinas Healthcare System|Main Line Fertility Center|Fellows Research Alliance, Inc.|Chattanooga Medical Research, Llc|Texas Health Care, Pllc|Millennium Clinical Trials, Llc",{"$nulls":3},"Bayer Study Director","2019-07-17","2020-05-25T16:37:11.081","2020-05-26T17:10:42.972","NCT03400943"]
["5ecbf437307e3d1b1f8d9d18","NCT03400943","2019-09-24","Bayer","BAYN","Active, not recruiting","Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 3)","Bay-1002670|Vilaprisan","PR Modulator","Yes","['Bay-1002670', 'Vilaprisan']","No",null,"Phase 3",4,260,"Anticipated","2018-01-17","2021-11-13",{"$nulls":5},"The primary objective of this study is to show superiority in the treatment of HMB of vilaprisan in subjects with uterine fibroids compared to placebo.\n\nThe secondary objectives of this study are to additionally evaluate the efficacy and safety of vilaprisan in subjects with uterine fibroids.",null,"A Randomized, Parallel-group, Double-blind and Open-label Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Vilaprisan in Subjects With Uterine Fibroids",15787,"Leiomyoma","Leiomyoma|Myoma","Oncology Solid Tumor","Oncology","Experimental","Vilaprisan_A1|Vilaprisan_A2|Vilaprisan_B1|Vilaprisan_B2","vilaprisan (2 mg), 2 treatment periods of 12 weeks, separated by 1 bleeding episode|vilaprisan (2 mg), 2 treatment periods of 12 weeks without a break|placebo, 1 treatment period of 12 weeks, and vilaprisan (2 mg), 1 treatment period of 12 weeks, separated by 1 bleeding episode|vilaprisan (2 mg), 1 treatment period of 12 weeks, and placebo, 1 treatment period of 12 weeks, separated by 1 bleeding episode","Drug","Vilaprisan (BAY1002670)|Placebo","2 mg of Vilaprisan once daily up to 2 x 12 weeks|Matching placebo is administered to group B1 and B2.",null,"Vilaprisan_A1|Vilaprisan_A2|Vilaprisan_B1|Vilaprisan_B2","\n\n * Women, 18 years or older in good General health\n * Diagnosis of uterine fibroid(s) documented by ultrasound at screening with at least 1 fibroid with largest Diameter â‰¥ 30 mm and < 120 mm\n * Heavy menstrual bleeding (HMB) in at least 2 bleeding periods during the Screening period each with blood loss volume of >80.00 mL documented by alkaline hematin (AH) method\n * An endometrial biopsy performed during the Screening period without significant histological disorder such as endometrial hyperplasia (including simple hyperplasia) or other significant endometrial pathology\n * Use of an acceptable non-hormonal method of contraception (ie, either male condom, cap, diaphragm or sponge, each in combination with spermicide) starting at Visit 1 until the end of the study\n\n","\n\n * Pregnancy or lactation (less than 3 month since delivery, abortion, or lactation before start of Treatment)\n * Hypersensitivity to any ingredient of the study drug\n * Any condition requiring immediate blood transfusion\n * Laboratory values outside inclusion range before randomization and considered as clinically relevant.\n * Any diseases, conditions, or medications that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study drug\n * Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results\n * Abuse of alcohol, drugs, or medicines (eg, laxatives)\n * Use of other treatments that might interfere with the conduct of the study or the interpretation of the results\n * Undiagnosed abnormal genital bleeding",{"$nulls":4},"Actual","2018-01-17","Actual","Anticipated","2021-11-13","Anticipated","2019-09-01","2018-01-05","2018-01-15","2019-09-23","No","Uterine fibroids\nHeavy menstrual bleeding","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"Female",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"2017-002997-38","EudraCT Number","Amenorrhea (yes/no)","Amenorrhea (yes/no), defined as MBL <2 mL during the last 28 days of treatment","The last 28 days of treatment period 1 and treatment period 2","Heavy Menstrual Bleeding (HMB) response|Time to onset of amenorrhea|Time to onset of controlled bleeding|Absence of bleeding (spotting allowed)|Endometrial histology|Endometrial thickness","HMB response defined as blood loss <80.00 mL during the last 28 days of treatment and >50% reduction compared to baseline|Onset of amenorrhea is defined by the first day for which the menstrual blood loss for all subsequent 28-day periods up to the end of the treatment period is <2 mL|By Uterine Fibroid Daily Bleeding Diary (UF-DBD)|Benign endometrium, presence or absence of hyperplasia or malignancy|Up to 36 weeks","The last 28 days of treatment period 1 and treatment period 2|In treatment period 1 (12 weeks) and in treatment period 2 (12 weeks)|Up to 36 weeks",{"$nulls":3},"Gabrovo, Bulgaria, 5300 Hospital For Active Treatment - Prof.Paraskev Stoyanov AdLovech, Bulgaria, 5500 Mhat Dr. Bratan Shukerov AdSmolyan, Bulgaria, 4700 Mhat For Women'S Health - Nadezhda OodSofia, Bulgaria, 1330|Beijing, China, 100010 Peking University First HospitalBeijing, China, 100034 Beijing Friendship Hospital, Capital Medical UniversityBeijing, China, 100050 Beijing Tiantan Hospital, Captial Medical UniversityBeijing, China, 100050 Beijing Luhe Hospital Of Capital Medicial UniversityBeijing, China, 101199 Shanghai East Hospital Affiated To Tongji UniversityShanghai, China, 200123 Tianjin Medical University General HospitalTianjin, China, 300052 Tianjin Central Hospital Of Gynecology ObstetricsTianjin, China, 300199|Fuzhou, Fujian, China, 350025|Lanzhou, Gansu, China, 730030|Guangzhou, Guangdong, China, 510623 The Third Affiliated Hospital, Sun Yat-Sen UniversityGuangzhou, Guangdong, China, 510630 Boai Hospital Of ZhongshanZhongshan, Guangdong, China|Nanning, Guangxi, China, 530021|Haikou, Hainan, China, 570311|Shijiazhuang, Hebei, China, 050000|Wuhan, Hubei, China, 430013|Nanjing, Jiangsu, China, 210004 Nanjing First HospitalNanjing, Jiangsu, China, 210006 Nj Drum Tower Hospital, The Affil Hos Of Nj Univ Med SchoolNanjing, Jiangsu, China, 210008 Zhongda Hospital Southeast UniversityNanjing, Jiangsu, China, 210009 The Second Affiliated Hospital Of Nanjing Medical UniversityNanjing, Jiangsu, China, 210011 1St Affiliated Hospital Of Soochow UniversitySuzhou, Jiangsu, China, 215006|Nanchang, Jiangxi, China, 330006 The Second Affiliated Hospital Of Nanchang UniversityNanchang, Jiangxi, China, 330006|Changchun, Jilin, China, 130000 The First Hospital Of Jilin UniversityChangchun, Jilin, China, 130021|Dalian, Liaoning, China, 116011 Shengjing Hospital Of|Shenyang, Liaoning, China, 110004|Yinchuan, Ningxia, China, 750004|Chengdu, Sichuan, China, 610041|Xi'An, Shaanxi, China, 710004|Xi'An, Shaanxi, China, 710061|Taiyuan, Shanxi, China, 030001|Urumqi, Xinjiang, China, 830054|Hangzhou, Zhejiang, China, 310006 Sir Run Run Shaw Hospital, Zhejiang Univ. School Of MedicineHangzhou, Zhejiang, China, 310016 The First Affiliated Hospital Of Wenzhou Medical Univ (New)Wenzhou, Zhejiang, China, 325000 The Second Affliated Hospital Of Wenzhou Medicial UniversityWenzhou, Zhejiang, China, 325000|Brno, Czechia, 602 00 Soukroma Gynekologicka AmbulanceFulnek, Czechia, 74245 Gynekologie Studentsky Dum S.R.O.Praha 6, Czechia, 160 00 Mudr. Ivana Salamonova S.R.O.Vysoke Myto, Czechia, 566 01|Atlanta, Georgia, United States, 30312 Agile Clinical Research Trials, LlcAtlanta, Georgia, United States, 30328 Atlanta Women'S Research Institute, Inc.Atlanta, Georgia, United States, 30342 Medisense, Inc.Atlanta, Georgia, United States, 30363 Paramount Research SolutionsCollege Park, Georgia, United States, 30349 Atlanta Gynecology Research InstitutePeachtree Corners, Georgia, United States, 30092 Fellows Research AllianceSavannah, Georgia, United States, 31406|Afula, Israel, 1834111 Hillel Yaffe Medical CenterHadera, Israel, 3810101 Rambam Health CorporationHaifa, Israel, 3109601 Lady Davis Carmel Medical CenterHaifa, Israel, 3436212 Meir Medical CenterKfar Saba, Israel, 4428164|Hawkes Bay, New Zealand, 4130 P3 ResearchTauranga, New Zealand, 3110|Johannesburg, Gauteng, South Africa, 2193 Dr L Reynders PracticeLyttelton Manor, Gauteng, South Africa, 0141 Wilgeheuwel HospitalRoodepoort, Gauteng, South Africa, 1724|Durban, Kwazulu-Natal, South Africa, 4319 Ethekwini Hospital & Heart CentreDurban, Kwazulu-Natal, South Africa|Birmingham, Alabama, United States, 35294-0026|Arcadia, California, United States, 91007 Core Healthcare GroupCerritos, California, United States, 90703 Aviva ResearchEscondido, California, United States, 92025 National Research InstituteLos Angeles, California, United States, 90057 Harbor - Ucla Medical CenterTorrance, California, United States, 90509-2910|Aventura, Florida, United States, 33180 South Florida Medical ResearchAventura, Florida, United States, 33180 Helix Biomedics, LlcBoynton Beach, Florida, United States, 33435 Dr. Victoria Garcia & Associates, Llc Doral Medical ResearchDoral, Florida, United States, 33166 Sweet Hope Research Specialty, Inc.Hialeah, Florida, United States, 33016 Clinical Neurosciences Solutions, Inc. Dba Cns HealthcareJacksonville, Florida, United States, 32256 Altus ResearchLake Worth, Florida, United States, 33461 Axcess Medical Research, LlcLoxahatchee Groves, Florida, United States, 33470 Ocean Blue Medical Research Center, Inc.Miami Springs, Florida, United States, 33166 Serenity Holistic ObgynMiami, Florida, United States, 33181 Compass Research, LlcOrlando, Florida, United States, 32806 Discovery Clinical ResearchPlantation, Florida, United States, 33324 Oncova Clinical Research, Inc.Saint Cloud, Florida, United States, 34769|Shawnee Mission, Kansas, United States, 66218|Shreveport, Louisiana, United States, 71118|Baltimore, Maryland, United States, 21208 Simmonds, Martin And HelmbrechtGaithersburg, Maryland, United States, 20878 Advantia Health, Llc Obstetrics & Gynecology Assoc.Silver Spring, Maryland, United States, 20910|Brooklyn, New York, United States, 11203|Charlotte, North Carolina, United States, 28204 Unified Women'S Clinical Research - Morehead CityMorehead City, North Carolina, United States, 28557 Eastern Carolina Women'S CenterNew Bern, North Carolina, United States, 28562 Wake Research AssociatesRaleigh, North Carolina, United States, 27612|Bryn Mawr, Pennsylvania, United States, 19010 Clinical Research Of Philadelphia, LlcPhiladelphia, Pennsylvania, United States, 19114|Bluffton, South Carolina, United States, 29910 Medical University Of South CarolinaCharleston, South Carolina, United States, 29425 Fusion Clinical Research Of Spartanburg, LlcSpartanburg, South Carolina, United States, 29301|Chattanooga, Tennessee, United States, 37404 Clinical Neurosciences Solutions, Inc Dba Cns HealthcareMemphis, Tennessee, United States, 38119 Paramount Research SolutionsNashville, Tennessee, United States, 37203|Fort Worth, Texas, United States, 76104 Willowbend Health & Wellness AssociatesFrisco, Texas, United States, 75035 Family Medicine ClinicGeorgetown, Texas, United States, 78626 Biopharma Informatic, Inc.Houston, Texas, United States, 77043 Centex Studies, Inc.Houston, Texas, United States, 77058 The Center For Clinical Trials, Inc.Houston, Texas, United States, 77082 Houston Center For Clinical Research, LlcSugar Land, Texas, United States, 77479|Arlington, Virginia, United States, 22207 Inova Fairfax HospitalFalls Church, Virginia, United States, 22042 Synexus Research, LlcRichmond, Virginia, United States, 23226","Alabama|California|Florida|Kansas|Louisiana|Maryland|New York|North Carolina|Pennsylvania|South Carolina|Tennessee|Texas|Virginia","Bulgaria|China|Czechia|Georgia|Israel|New Zealand|South Africa|United States","Multiprofile Hospital For Active Treatment-Dr. T. Venkova Ad|Beijing Hospital Of Traditional Chinese Medicine|Fujian 900Th Hospital Of Joint Logistics Support Force|Gansu Lanzhou University Second Hospital|Guangdong Guangzhou Women And Children's Medical Center|Guangxi The People's Hospital Of Guangxi Zhuang Autonomous Region|Hainan Hainan General Hospital|Hebei The 2Nd Hospital Of Hebei Medical University|Hubei Center For Reproductive Medicine,Tongji Medical College,Hust|Jiangsu Nanjing Maternity And Child Health Care Hospital|Jiangxi Jiangxi Maternal And Child Health Hospital|Jilin The Second Hospital Of Jilin University|Liaoning The First Affiliated Hospital Of Dalian Medical University|Medical University|Ningxia General Hospital Of Ningxia Medical University|Second University Hospital|Shaanxi Second Affiliated Hospital Xian Jiaotong University School|Shaanxi The 1St Affiliated Hospital Of Xi'An Jiaotong University|Shanxi The Second Affiliated Hospital Of Shanxi Medical University|Xinjiang The First Affiliated Hospital Of Xinjiang Medical University|Zhejiang Women's Hospital School Of Medicine Zhejiang University|Gynekologie Meda S.R.O.|Center For Women|Haemek Medical Center|P3 Research Ltd Hawkes Bay|, Gauteng Wits Clinical Research Site|, Kwazulu-Natal Umhlanga Medical Centre|University Of Alabama At Birmingham|California Center For Clinical Research|Ideal Clinical Research|Gtc Research|Omni Fertility And Laser Institute|Pharmasite Research, Inc.|Suny Downstate Medical Center|Carolinas Healthcare System|Main Line Fertility Center|Fellows Research Alliance, Inc.|Chattanooga Medical Research, Llc|Texas Health Care, Pllc|Millennium Clinical Trials, Llc",{"$nulls":3},"Bayer Study Director","2019-09-23","2020-05-25T16:37:11.239","2020-05-26T17:10:42.972","NCT03400943"]
["5ecbf437fe30261b1a048288","NCT03400943","2020-01-10","Bayer","BAYN","Active, not recruiting","Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 3)","Bay-1002670|Vilaprisan","PR Modulator","Yes","['Bay-1002670', 'Vilaprisan']","No",null,"Phase 3",4,260,"Anticipated","2018-01-17","2020-12-31",{"$nulls":5},"The primary objective of this study is to show superiority in the treatment of HMB of vilaprisan in subjects with uterine fibroids compared to placebo.\n\nThe secondary objectives of this study are to additionally evaluate the efficacy and safety of vilaprisan in subjects with uterine fibroids.",null,"A Randomized, Parallel-group, Double-blind and Open-label Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Vilaprisan in Subjects With Uterine Fibroids",15787,"Leiomyoma","Leiomyoma|Myoma","Oncology Solid Tumor","Oncology","Experimental","Vilaprisan_A1|Vilaprisan_A2|Vilaprisan_B1|Vilaprisan_B2","vilaprisan (2 mg), 2 treatment periods of 12 weeks, separated by 1 bleeding episode|vilaprisan (2 mg), 2 treatment periods of 12 weeks without a break|placebo, 1 treatment period of 12 weeks, and vilaprisan (2 mg), 1 treatment period of 12 weeks, separated by 1 bleeding episode|vilaprisan (2 mg), 1 treatment period of 12 weeks, and placebo, 1 treatment period of 12 weeks, separated by 1 bleeding episode","Drug","Vilaprisan (BAY1002670)|Placebo","2 mg of Vilaprisan once daily up to 2 x 12 weeks|Matching placebo is administered to group B1 and B2.",null,"Vilaprisan_A1|Vilaprisan_A2|Vilaprisan_B1|Vilaprisan_B2","\n\n * Women, 18 years or older in good General health\n * Diagnosis of uterine fibroid(s) documented by ultrasound at screening with at least 1 fibroid with largest Diameter â‰¥ 30 mm and < 120 mm\n * Heavy menstrual bleeding (HMB) in at least 2 bleeding periods during the Screening period each with blood loss volume of >80.00 mL documented by alkaline hematin (AH) method\n * An endometrial biopsy performed during the Screening period without significant histological disorder such as endometrial hyperplasia (including simple hyperplasia) or other significant endometrial pathology\n * Use of an acceptable non-hormonal method of contraception (ie, either male condom, cap, diaphragm or sponge, each in combination with spermicide) starting at Visit 1 until the end of the study\n\n","\n\n * Pregnancy or lactation (less than 3 month since delivery, abortion, or lactation before start of Treatment)\n * Hypersensitivity to any ingredient of the study drug\n * Any condition requiring immediate blood transfusion\n * Laboratory values outside inclusion range before randomization and considered as clinically relevant.\n * Any diseases, conditions, or medications that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study drug\n * Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results\n * Abuse of alcohol, drugs, or medicines (eg, laxatives)\n * Use of other treatments that might interfere with the conduct of the study or the interpretation of the results\n * Undiagnosed abnormal genital bleeding",{"$nulls":4},"Actual","2018-01-17","Actual","Anticipated","2020-12-31","Anticipated","2019-12-01","2018-01-05","2018-01-15","2020-01-08","No","Uterine fibroids\nHeavy menstrual bleeding","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"Female",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"2017-002997-38","EudraCT Number","Amenorrhea (yes/no)","Amenorrhea (yes/no), defined as MBL <2 mL during the last 28 days of treatment","The last 28 days of treatment period 1 and treatment period 2","Heavy Menstrual Bleeding (HMB) response|Time to onset of amenorrhea|Time to onset of controlled bleeding|Absence of bleeding (spotting allowed)|Endometrial histology|Endometrial thickness","HMB response defined as blood loss <80.00 mL during the last 28 days of treatment and >50% reduction compared to baseline|Onset of amenorrhea is defined by the first day for which the menstrual blood loss for all subsequent 28-day periods up to the end of the treatment period is <2 mL|By Uterine Fibroid Daily Bleeding Diary (UF-DBD)|Benign endometrium, presence or absence of hyperplasia or malignancy|Up to 36 weeks","The last 28 days of treatment period 1 and treatment period 2|In treatment period 1 (12 weeks) and in treatment period 2 (12 weeks)|Up to 36 weeks",{"$nulls":3},"Gabrovo, Bulgaria, 5300 Hospital For Active Treatment - Prof.Paraskev Stoyanov AdLovech, Bulgaria, 5500 Mhat Dr. Bratan Shukerov AdSmolyan, Bulgaria, 4700 Mhat For Women'S Health - Nadezhda OodSofia, Bulgaria, 1330|Beijing, China, 100010 Peking University First HospitalBeijing, China, 100034 Beijing Friendship Hospital, Capital Medical UniversityBeijing, China, 100050 Beijing Tiantan Hospital, Captial Medical UniversityBeijing, China, 100050 Beijing Luhe Hospital Of Capital Medicial UniversityBeijing, China, 101199 Shanghai East Hospital Affiated To Tongji UniversityShanghai, China, 200123 Tianjin Medical University General HospitalTianjin, China, 300052|Fuzhou, Fujian, China, 350025|Lanzhou, Gansu, China, 730030|Guangzhou, Guangdong, China, 510623 The Third Affiliated Hospital, Sun Yat-Sen UniversityGuangzhou, Guangdong, China, 510630 Boai Hospital Of ZhongshanZhongshan, Guangdong, China|Nanning, Guangxi, China, 530021|Haikou, Hainan, China, 570311|Wuhan, Hubei, China, 430013|Nanjing, Jiangsu, China, 210004 Nanjing First HospitalNanjing, Jiangsu, China, 210006 Nj Drum Tower Hospital, The Affil Hos Of Nj Univ Med SchoolNanjing, Jiangsu, China, 210008 Zhongda Hospital Southeast UniversityNanjing, Jiangsu, China, 210009 The Second Affiliated Hospital Of Nanjing Medical UniversityNanjing, Jiangsu, China, 210011 1St Affiliated Hospital Of Soochow UniversitySuzhou, Jiangsu, China, 215006|Nanchang, Jiangxi, China, 330006 The Second Affiliated Hospital Of Nanchang UniversityNanchang, Jiangxi, China, 330006|Changchun, Jilin, China, 130021|Dalian, Liaoning, China, 116011 Shengjing Hospital Of|Shenyang, Liaoning, China, 110004|Yinchuan, Ningxia, China, 750004|Xi'An, Shaanxi, China, 710004|Xi'An, Shaanxi, China, 710061|Taiyuan, Shanxi, China, 030001|Urumqi, Xinjiang, China, 830054|Hangzhou, Zhejiang, China, 310006 Sir Run Run Shaw Hospital, Zhejiang Univ. School Of MedicineHangzhou, Zhejiang, China, 310016 The First Affiliated Hospital Of Wenzhou Medical Univ (New)Wenzhou, Zhejiang, China, 325000 The Second Affliated Hospital Of Wenzhou Medicial UniversityWenzhou, Zhejiang, China, 325000|Brno, Czechia, 602 00 Soukroma Gynekologicka AmbulanceFulnek, Czechia, 74245 Gynekologie Studentsky Dum S.R.O.Praha 6, Czechia, 160 00 Mudr. Ivana Salamonova S.R.O.Vysoke Myto, Czechia, 566 01|Atlanta, Georgia, United States, 30312 Agile Clinical Research Trials, LlcAtlanta, Georgia, United States, 30328 Atlanta Women'S Research Institute, Inc.Atlanta, Georgia, United States, 30342 Medisense, Inc.Atlanta, Georgia, United States, 30363 Paramount Research SolutionsCollege Park, Georgia, United States, 30349 One Health Research ClinicNorcross, Georgia, United States, 30093 Fellows Research AllianceSavannah, Georgia, United States, 31406|Afula, Israel, 1834111 Hillel Yaffe Medical CenterHadera, Israel, 3810101 Lady Davis Carmel Medical CenterHaifa, Israel, 3436212 Meir Medical CenterKfar Saba, Israel, 4428164|Hawkes Bay, New Zealand, 4130 P3 ResearchTauranga, New Zealand, 3110|Johannesburg, Gauteng, South Africa, 2193 Dr L Reynders PracticeLyttelton Manor, Gauteng, South Africa, 0141 Wilgeheuwel HospitalRoodepoort, Gauteng, South Africa, 1724|Durban, Kwazulu-Natal, South Africa, 4319 Ethekwini Hospital & Heart CentreDurban, Kwazulu-Natal, South Africa|Birmingham, Alabama, United States, 35294-0026|Arcadia, California, United States, 91007 Core Healthcare GroupCerritos, California, United States, 90703 Aviva ResearchEscondido, California, United States, 92025 National Research InstituteLos Angeles, California, United States, 90057 Harbor - Ucla Medical CenterTorrance, California, United States, 90509-2910|Aventura, Florida, United States, 33180 South Florida Medical ResearchAventura, Florida, United States, 33180 Helix Biomedics, LlcBoynton Beach, Florida, United States, 33435 Dr. Victoria Garcia & Associates, Llc Doral Medical ResearchDoral, Florida, United States, 33166 Sweet Hope Research Specialty, Inc.Hialeah, Florida, United States, 33016 Clinical Neurosciences Solutions, Inc. Dba Cns HealthcareJacksonville, Florida, United States, 32256 Altus ResearchLake Worth, Florida, United States, 33461 Axcess Medical Research, LlcLoxahatchee Groves, Florida, United States, 33470 Ocean Blue Medical Research Center, Inc.Miami Springs, Florida, United States, 33166 Serenity Holistic ObgynNorth Miami Beach, Florida, United States, 33162 Accelerated Enrollment Solutions A Business Of PpdOrlando, Florida, United States, 32808 Discovery Clinical ResearchPlantation, Florida, United States, 33324 Oncova Clinical Research, Inc.Saint Cloud, Florida, United States, 34769|Shawnee Mission, Kansas, United States, 66218|Shreveport, Louisiana, United States, 71118|Baltimore, Maryland, United States, 21208 Simmonds, Martin And HelmbrechtGaithersburg, Maryland, United States, 20878 Advantia Health, Llc Obstetrics & Gynecology Assoc.Silver Spring, Maryland, United States, 20910|Brooklyn, New York, United States, 11203|Charlotte, North Carolina, United States, 28204 Unified Women'S Clinical Research - Morehead CityMorehead City, North Carolina, United States, 28557 Eastern Carolina Women'S CenterNew Bern, North Carolina, United States, 28562 Wake Research AssociatesRaleigh, North Carolina, United States, 27612|Bryn Mawr, Pennsylvania, United States, 19010 Clinical Research Of Philadelphia, LlcPhiladelphia, Pennsylvania, United States, 19114|Bluffton, South Carolina, United States, 29910 Medical University Of South CarolinaCharleston, South Carolina, United States, 29425 Fusion Clinical Research Of Spartanburg, LlcSpartanburg, South Carolina, United States, 29301|Chattanooga, Tennessee, United States, 37404 Clinical Neurosciences Solutions, Inc Dba Cns HealthcareMemphis, Tennessee, United States, 38119 Paramount Research SolutionsNashville, Tennessee, United States, 37203|Fort Worth, Texas, United States, 76104 Willowbend Health & Wellness AssociatesFrisco, Texas, United States, 75035 Family Medicine ClinicGeorgetown, Texas, United States, 78626 Biopharma Informatic, Inc.Houston, Texas, United States, 77043 Centex Studies, Inc.Houston, Texas, United States, 77058 The Center For Clinical Trials, Inc.Houston, Texas, United States, 77082 Houston Center For Clinical Research, LlcSugar Land, Texas, United States, 77479|Arlington, Virginia, United States, 22207 Inova Fairfax HospitalFalls Church, Virginia, United States, 22042 Synexus Research, LlcRichmond, Virginia, United States, 23226","Alabama|California|Florida|Kansas|Louisiana|Maryland|New York|North Carolina|Pennsylvania|South Carolina|Tennessee|Texas|Virginia","Bulgaria|China|Czechia|Georgia|Israel|New Zealand|South Africa|United States","Multiprofile Hospital For Active Treatment-Dr. T. Venkova Ad|Beijing Hospital Of Traditional Chinese Medicine|Fujian 900Th Hospital Of Joint Logistics Support Force|Gansu Lanzhou University Second Hospital|Guangdong Guangzhou Women And Children's Medical Center|Guangxi The People's Hospital Of Guangxi Zhuang Autonomous Region|Hainan Hainan General Hospital|Hubei Center For Reproductive Medicine,Tongji Medical College,Hust|Jiangsu Nanjing Maternity And Child Health Care Hospital|Jiangxi Jiangxi Maternal And Child Health Hospital|Jilin The First Hospital Of Jilin University|Liaoning The First Affiliated Hospital Of Dalian Medical University|Medical University|Ningxia General Hospital Of Ningxia Medical University|Shaanxi Second Affiliated Hospital Xian Jiaotong University School|Shaanxi The 1St Affiliated Hospital Of Xi'An Jiaotong University|Shanxi The Second Affiliated Hospital Of Shanxi Medical University|Xinjiang The First Affiliated Hospital Of Xinjiang Medical University|Zhejiang Women's Hospital School Of Medicine Zhejiang University|Gynekologie Meda S.R.O.|Center For Women|Haemek Medical Center|P3 Research Ltd Hawkes Bay|, Gauteng Wits Clinical Research Site|, Kwazulu-Natal Umhlanga Medical Centre|University Of Alabama At Birmingham|California Center For Clinical Research|Ideal Clinical Research|Gtc Research|Omni Fertility And Laser Institute|Pharmasite Research, Inc.|Suny Downstate Medical Center|Carolinas Healthcare System|Main Line Fertility Center|Fellows Research Alliance, Inc.|Chattanooga Medical Research, Llc|Texas Health Care, Pllc|Millennium Clinical Trials, Llc",{"$nulls":3},"Bayer Study Director","2020-01-08","2020-05-25T16:37:11.559","2020-05-26T17:10:42.972","NCT03400943"]
["5ecbf437e2561b1b11905d84","NCT03400943","2020-04-06","Bayer","BAYN","Active, not recruiting","Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 3)","Bay-1002670|Vilaprisan","PR Modulator","Yes","['Bay-1002670', 'Vilaprisan']","No",null,"Phase 3",4,260,"Anticipated","2018-01-17","2019-06-09",{"$nulls":5},"The primary objective of this study is to show superiority in the treatment of HMB of vilaprisan in subjects with uterine fibroids compared to placebo.\n\nThe secondary objectives of this study are to additionally evaluate the efficacy and safety of vilaprisan in subjects with uterine fibroids.",null,"A Randomized, Parallel-group, Double-blind and Open-label Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Vilaprisan in Subjects With Uterine Fibroids",15787,"Leiomyoma","Leiomyoma|Myoma","Oncology Solid Tumor","Oncology","Experimental","Vilaprisan_A1|Vilaprisan_A2|Vilaprisan_B1|Vilaprisan_B2","vilaprisan (2 mg), 2 treatment periods of 12 weeks, separated by 1 bleeding episode|vilaprisan (2 mg), 2 treatment periods of 12 weeks without a break|placebo, 1 treatment period of 12 weeks, and vilaprisan (2 mg), 1 treatment period of 12 weeks, separated by 1 bleeding episode|vilaprisan (2 mg), 1 treatment period of 12 weeks, and placebo, 1 treatment period of 12 weeks, separated by 1 bleeding episode","Drug","Vilaprisan (BAY1002670)|Placebo","2 mg of Vilaprisan once daily up to 2 x 12 weeks|Matching placebo is administered to group B1 and B2.",null,"Vilaprisan_A1|Vilaprisan_A2|Vilaprisan_B1|Vilaprisan_B2","\n\n * Women, 18 years or older in good General health\n * Diagnosis of uterine fibroid(s) documented by ultrasound at screening with at least 1 fibroid with largest Diameter â‰¥ 30 mm and < 120 mm\n * Heavy menstrual bleeding (HMB) in at least 2 bleeding periods during the Screening period each with blood loss volume of >80.00 mL documented by alkaline hematin (AH) method\n * An endometrial biopsy performed during the Screening period without significant histological disorder such as endometrial hyperplasia (including simple hyperplasia) or other significant endometrial pathology\n * Use of an acceptable non-hormonal method of contraception (ie, either male condom, cap, diaphragm or sponge, each in combination with spermicide) starting at Visit 1 until the end of the study\n\n","\n\n * Pregnancy or lactation (less than 3 month since delivery, abortion, or lactation before start of Treatment)\n * Hypersensitivity to any ingredient of the study drug\n * Any condition requiring immediate blood transfusion\n * Laboratory values outside inclusion range before randomization and considered as clinically relevant.\n * Any diseases, conditions, or medications that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study drug\n * Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results\n * Abuse of alcohol, drugs, or medicines (eg, laxatives)\n * Use of other treatments that might interfere with the conduct of the study or the interpretation of the results\n * Undiagnosed abnormal genital bleeding",{"$nulls":4},"Actual","2018-01-17","Actual","Actual","2020-12-31","Anticipated","2020-03-01","2018-01-05","2018-01-15","2020-03-31","No","Uterine fibroids\nHeavy menstrual bleeding","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"Female",null,"No",{"$nulls":4},"Yes","No",{"$nulls":7},43907,43921,"April 6, 2020 [Actual]",{"$nulls":7},"2017-002997-38","EudraCT Number","Amenorrhea (yes/no)","Amenorrhea (yes/no), defined as MBL <2 mL during the last 28 days of treatment","The last 28 days of treatment period 1","Heavy Menstrual Bleeding (HMB) response|Time to onset of amenorrhea|Time to onset of controlled bleeding|Absence of bleeding (spotting allowed)|Endometrial histology|Endometrial thickness","HMB response defined as blood loss <80.00 mL during the last 28 days of treatment and >50% reduction compared to baseline|Onset of amenorrhea is defined by the first day for which the menstrual blood loss for all subsequent 28-day periods up to the end of the treatment period is <2 mL|By Uterine Fibroid Daily Bleeding Diary (UF-DBD)|Benign endometrium, presence or absence of hyperplasia or malignancy|Up to 36 weeks","The last 28 days of treatment period 1 and treatment period 2|In treatment period 1 (12 weeks) and in treatment period 2 (12 weeks)|Up to 36 weeks",{"$nulls":3},"Gabrovo, Bulgaria, 5300 Hospital For Active Treatment - Prof.Paraskev Stoyanov AdLovech, Bulgaria, 5500 Mhat Dr. Bratan Shukerov AdSmolyan, Bulgaria, 4700 Mhat For Women'S Health - Nadezhda OodSofia, Bulgaria, 1330|Beijing, China, 100010 Peking University First HospitalBeijing, China, 100034 Beijing Friendship Hospital, Capital Medical UniversityBeijing, China, 100050 Beijing Tiantan Hospital, Captial Medical UniversityBeijing, China, 100050 Shanghai East Hospital Affiated To Tongji UniversityShanghai, China, 200123 Tianjin Medical University General HospitalTianjin, China, 300052|Fuzhou, Fujian, China, 350025|Guangzhou, Guangdong, China, 510623 The Third Affiliated Hospital, Sun Yat-Sen UniversityGuangzhou, Guangdong, China, 510630 Boai Hospital Of ZhongshanZhongshan, Guangdong, China|Haikou, Hainan, China, 570311|Wuhan, Hubei, China, 430013|Nanjing, Jiangsu, China, 210004 Nj Drum Tower Hospital, The Affil Hos Of Nj Univ Med SchoolNanjing, Jiangsu, China, 210008 Zhongda Hospital Southeast UniversityNanjing, Jiangsu, China, 210009 1St Affiliated Hospital Of Soochow UniversitySuzhou, Jiangsu, China, 215006|Nanchang, Jiangxi, China, 330006 The Second Affiliated Hospital Of Nanchang UniversityNanchang, Jiangxi, China, 330006|Changchun, Jilin, China, 130021|Dalian, Liaoning, China, 116011 Shengjing Hospital Of|Shenyang, Liaoning, China, 110004|Yinchuan, Ningxia, China, 750004|Xi'An, Shaanxi, China, 710004 The 1St Affiliated Hospital Of Xi'An Jiaotong UniversityXi'An, Shaanxi, China, 710061|Taiyuan, Shanxi, China, 030001|Urumqi, Xinjiang, China, 830054|Hangzhou, Zhejiang, China, 310006 Sir Run Run Shaw Hospital, Zhejiang Univ. School Of MedicineHangzhou, Zhejiang, China, 310016 The Second Affliated Hospital Of Wenzhou Medicial UniversityWenzhou, Zhejiang, China, 325000|Brno, Czechia, 602 00 Soukroma Gynekologicka AmbulanceFulnek, Czechia, 74245 Gynekologie Studentsky Dum S.R.O.Praha 6, Czechia, 160 00 Mudr. Ivana Salamonova S.R.O.Vysoke Myto, Czechia, 566 01|Atlanta, Georgia, United States, 30312 Agile Clinical Research Trials, LlcAtlanta, Georgia, United States, 30328 Atlanta Women'S Research Institute, Inc.Atlanta, Georgia, United States, 30342 Medisense, Inc.Atlanta, Georgia, United States, 30363 Paramount Research SolutionsCollege Park, Georgia, United States, 30349 One Health Research ClinicNorcross, Georgia, United States, 30093 Fellows Research AllianceSavannah, Georgia, United States, 31406|Afula, Israel, 1834111 Hillel Yaffe Medical CenterHadera, Israel, 3810101 Lady Davis Carmel Medical CenterHaifa, Israel, 3436212 Meir Medical CenterKfar Saba, Israel, 4428164|Hawkes Bay, New Zealand, 4130 P3 ResearchTauranga, New Zealand, 3110|Lyttelton Manor, Gauteng, South Africa, 0141 Wilgeheuwel HospitalRoodepoort, Gauteng, South Africa, 1724|Durban, Kwazulu-Natal, South Africa, 4319 Ethekwini Hospital & Heart CentreDurban, Kwazulu-Natal, South Africa|Birmingham, Alabama, United States, 35294-0026|Arcadia, California, United States, 91007 Core Healthcare GroupCerritos, California, United States, 90703 Aviva ResearchEscondido, California, United States, 92025 National Research InstituteLos Angeles, California, United States, 90057 Harbor - Ucla Medical CenterTorrance, California, United States, 90509-2910|Aventura, Florida, United States, 33180 South Florida Medical ResearchAventura, Florida, United States, 33180 Helix Biomedics, LlcBoynton Beach, Florida, United States, 33435 Dr. Victoria Garcia & Associates, Llc Doral Medical ResearchDoral, Florida, United States, 33166 Sweet Hope Research Specialty, Inc.Hialeah, Florida, United States, 33016 Clinical Neurosciences Solutions, Inc. Dba Cns HealthcareJacksonville, Florida, United States, 32256 Altus ResearchLake Worth, Florida, United States, 33461 Axcess Medical Research, LlcLoxahatchee Groves, Florida, United States, 33470 Ocean Blue Medical Research Center, Inc.Miami Springs, Florida, United States, 33166 Accelerated Enrollment Solutions A Business Of PpdOrlando, Florida, United States, 32808 Discovery Clinical ResearchPlantation, Florida, United States, 33324 Oncova Clinical Research, Inc.Saint Cloud, Florida, United States, 34769|Shawnee Mission, Kansas, United States, 66218|Shreveport, Louisiana, United States, 71118|Baltimore, Maryland, United States, 21208 Simmonds, Martin And HelmbrechtGaithersburg, Maryland, United States, 20878 Advantia Health, Llc Obstetrics & Gynecology Assoc.Silver Spring, Maryland, United States, 20910|Brooklyn, New York, United States, 11203|Charlotte, North Carolina, United States, 28204 Unified Women'S Clinical Research - Morehead CityMorehead City, North Carolina, United States, 28557 Eastern Carolina Women'S CenterNew Bern, North Carolina, United States, 28562 Wake Research AssociatesRaleigh, North Carolina, United States, 27612|Bryn Mawr, Pennsylvania, United States, 19010 Clinical Research Of Philadelphia, LlcPhiladelphia, Pennsylvania, United States, 19114|Bluffton, South Carolina, United States, 29910 Medical University Of South CarolinaCharleston, South Carolina, United States, 29425 Fusion Clinical Research Of Spartanburg, LlcSpartanburg, South Carolina, United States, 29301|Chattanooga, Tennessee, United States, 37404 Clinical Neurosciences Solutions, Inc Dba Cns HealthcareMemphis, Tennessee, United States, 38119 Paramount Research SolutionsNashville, Tennessee, United States, 37203|Fort Worth, Texas, United States, 76104 Willowbend Health & Wellness AssociatesFrisco, Texas, United States, 75035 Family Medicine ClinicGeorgetown, Texas, United States, 78626 Biopharma Informatic, Inc.Houston, Texas, United States, 77043 Centex Studies, Inc.Houston, Texas, United States, 77058 The Center For Clinical Trials, Inc.Houston, Texas, United States, 77082 Houston Center For Clinical Research, LlcSugar Land, Texas, United States, 77479|Arlington, Virginia, United States, 22207 Synexus Research, LlcRichmond, Virginia, United States, 23226","Alabama|California|Florida|Kansas|Louisiana|Maryland|New York|North Carolina|Pennsylvania|South Carolina|Tennessee|Texas|Virginia","Bulgaria|China|Czechia|Georgia|Israel|New Zealand|South Africa|United States","Multiprofile Hospital For Active Treatment-Dr. T. Venkova Ad|Beijing Hospital Of Traditional Chinese Medicine|Fujian 900Th Hospital Of Joint Logistics Support Force|Guangdong Guangzhou Women And Children's Medical Center|Hainan Hainan General Hospital|Hubei Center For Reproductive Medicine,Tongji Medical College,Hust|Jiangsu Nanjing Maternity And Child Health Care Hospital|Jiangxi Jiangxi Maternal And Child Health Hospital|Jilin The First Hospital Of Jilin University|Liaoning The First Affiliated Hospital Of Dalian Medical University|Medical University|Ningxia General Hospital Of Ningxia Medical University|Shaanxi Second Affiliated Hospital Xian Jiaotong University School|Shanxi The Second Affiliated Hospital Of Shanxi Medical University|Xinjiang The First Affiliated Hospital Of Xinjiang Medical University|Zhejiang Women's Hospital School Of Medicine Zhejiang University|Gynekologie Meda S.R.O.|Center For Women|Haemek Medical Center|P3 Research Ltd Hawkes Bay|, Gauteng Dr L Reynders Practice|, Kwazulu-Natal Umhlanga Medical Centre|University Of Alabama At Birmingham|California Center For Clinical Research|Ideal Clinical Research|Gtc Research|Omni Fertility And Laser Institute|Pharmasite Research, Inc.|Suny Downstate Medical Center|Carolinas Healthcare System|Main Line Fertility Center|Fellows Research Alliance, Inc.|Chattanooga Medical Research, Llc|Texas Health Care, Pllc|Millennium Clinical Trials, Llc",{"$nulls":3},"Bayer Study Director","2020-03-31","2020-05-25T16:37:11.541","2020-05-26T17:10:42.972","NCT03400943"]
["5ecbf43711702c1b1b916a99","NCT03400956","2018-01-17","Bayer","BAYN","Not yet recruiting","Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 4)","Bay-1002670|Vilaprisan","PR Modulator","Yes","['Bay-1002670', 'Vilaprisan']","No",null,"Phase 3",3,156,"Anticipated","2018-02-20","2020-04-01",{"$nulls":5},"The primary objective of this study is to show superiority of vilaprisan in the treatment of heavy menstrual bleeding (HMB) in subjects with uterine fibroids compared to placebo.\n\nThe secondary objectives of this study are to additionally evaluate the efficacy and safety of vilaprisan in subjects with uterine fibroids.",null,"A Randomized, Parallel-group, Double-blind and Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Vilaprisan in Subjects With Uterine Fibroids",15790,"Leiomyoma","Leiomyoma|Myoma","Oncology Solid Tumor","Oncology","Experimental","Vilaprisan|Placebo+Vilaprisan|Vilaprisan+Placebo","Vilaprisan: 2 treatment periods of 12 weeks, separated by 1 bleeding episode.|Placebo: 1 treatment period of 12 weeks; and Vilaprisan: 1 treatment period of 12 weeks; separated by 1 bleeding episode.|Vilaprisan: 1 treatment period of 12 weeks; and Placebo: 1 treatment period of 12 weeks; separated by 1 bleeding episode.","Drug","Vilaprisan (BAY1002670)|Placebo","Orally, coated tablet 2 mg, once daily|Orally, coated tablet, once daily",null,"Vilaprisan|Placebo+Vilaprisan|Vilaprisan+Placebo","\n\n * Women, 18 years or older in good general health\n * Diagnosis of uterine fibroid(s) documented by ultrasound at screening with at least 1 fibroid with largest diameter more than 30 mm and less than 120 mm\n * Heavy menstrual bleeding (HMB) in at least 2 bleeding periods during the screening period each with blood loss volume of >80.00 mL documented by the alkaline hematin (AH) method\n * An endometrial biopsy performed during the screening period without significant histological disorder such as endometrial hyperplasia (including simple hyperplasia) or other significant endometrial pathology\n * Use of an acceptable non-hormonal method of contraception (ie, either male condom, cap, diaphragm or sponge, each in combination with spermicide) starting at Visit 1 until the end of the study\n\n","\n\n * Pregnancy or lactation (less than 3 months since delivery, abortion, or lactation before start of treatment)\n * Hypersensitivity to any ingredient of the study drug\n * Hemoglobin values â‰¤6 g/dL or any condition requiring immediate blood transfusion (subjects with hemoglobin values â‰¤10.9 g/dL will be recommended to use iron supplementation)\n * Any diseases, conditions, or medications that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study drug\n * Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results\n * Abuse of alcohol, drugs or medicines (e.g. laxatives)\n * Use of other treatments that might interfere with the conduct of the study or the interpretation of results\n * Undiagnosed abnormal genital bleeding",{"$nulls":4},"Actual","2018-01-17","Actual","Anticipated","2020-04-01","Anticipated","2018-01-01","2018-01-05","2018-01-15","2018-01-15","No","Uterine fibroids\nHeavy menstrual bleeding","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"Female",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"2016-003561-26","EudraCT Number","Amenorrhea (yes/no)","Defined as menstrual blood loss (MBL) < 2 mL during the last 28 days of treatment","The last 28 days of treatment period 1|The last 28 days of treatment period 2","HMB response|Time to onset of amenorrhea|Time to onset of controlled bleeding|Absence of bleeding (spotting allowed)|Endometrial histology|Endometrial thickness","Defined as blood loss <80.00 mL during the last 28 days of treatment and >50% reduction compared to baseline|Onset of amenorrhea is defined by the first day for which the menstrual blood loss for all subsequent 28-day periods up to the end of the treatment period is <2 mL|Onset of controlled bleeding is defined by the first day for which the menstrual blood loss for all subsequent 28-day periods up to the end of the treatment period is <80.00 mL|Based on the UF-DBD (Uterine Fibroid Daily Bleeding Diary)|E.g. benign endometrium, presence or absence of hyperplasia or malignancy|Up to 36 weeks","The last 28 days of treatment period 1 and treatment period 2|In treatment period 1 (12 weeks) and in treatment period 2 (12 weeks)|Up to 36 weeks","clinical-trials-contact@bayer.com","Bayer Clinical Trials Contact","(+) 1-888-8422937","Krnov, Czechia, 794 01 Gynekologie Mudr. Jaromir Karban S.R.ONeratovice, Czechia, 277 11 Privatni Gynekologicko-Porodnicka OrdinacePraha, Czechia, 16000 Gynevi S.R.O.Rokycany, Czechia, 337 01 Gynekologicka AmbulanceZabreh Na Morave, Czechia, 78901|Brasov, Romania, 500283 S.C. Sanador SrlBucharest, Romania, 011026 S.C. Genesys Fertility Center S.R.LBucuresti, Romania, 012071 S.C. Centrul Medical Euromed S.R.LBucuresti, Romania, 020762 Spitalul Clinic Nicolae MalaxaBucuresti, Romania, 022448 Spitalul Clinic Municipal Filantropia CraiovaCraiova, Romania, 200143 Russian Federation Altai State Medical UniversityBarnaul, Russian Federation, 656038 Regional Clinical Hospital #2Krasnodar, Russian Federation, 350012 Maternity Hospital, 17Saint-Petersburg, Russian Federation, 192174 Close Joint Stock Company \"Medical Company Idk\"Samara, Russian Federation, 443067 Smolensk State Medical UniversitySmolensk, Russian Federation, 214019 Med Estetic CenterSt. Petersburg, Russian Federation, 192177 Ooo \"Granti-Med\"St. Petersburg, Russian Federation, 198329 Scien. Res. Institute Of Obsterics, Gyn. & ReproductionSt. Petersburg, Russian Federation, 199034|Chernivtsi, Ukraine, 58001 Kharkiv Regional Clinical Perinatal CenterKharkiv, Ukraine, 61052 Vinnytsia City Clinical Maternity Hospital No 2Vinnytsia, Ukraine, 21001 Zaporizhzhia Regional Clinical HospitalZaporizhzhya, Ukraine, 69600|Canyon Country, California, United States, 91351 Diagnamics, Inc.Encinitas, California, United States, 92024 National Research InstituteHuntington Park, California, United States, 90255 Grossmont Center For Clinical ResearchLa Mesa, California, United States, 91942 West Coast Ob/Gyn AssociatesLa Mesa, California, United States, 91942 Artemis Institute For Clinical ResearchSan Diego, California, United States, 92103 Medical Center For Clinical ResearchSan Diego, California, United States, 92108|Clearwater, Florida, United States, 33759 Universal Axon Clinical ResearchDoral, Florida, United States, 33166 Vital Pharma ResearchHialeah, Florida, United States, 33106 Solutions Through Advanced Research, Inc.Jacksonville, Florida, United States, 32256 Health Awareness, Inc.Jupiter, Florida, United States, 33458 South Florida Clinical Research InstituteMargate, Florida, United States, 33073 Savin Medical Group LlcMiami Lakes, Florida, United States, 33014 Suncoast Research Group, LlcMiami, Florida, United States, 33135 Advanced Pharma Cr, LlcMiami, Florida, United States, 33147 Genoma Research Group, Inc.Miami, Florida, United States, 33165 Florida Research Center, Inc.Miami, Florida, United States, 33174 Palmetto Professional ResearchMiami, Florida, United States, 33175 Miami Dade Medical Research Institute, LlcMiami, Florida, United States, 33176 Vista Health ResearchMiami, Florida, United States, 33176 Midland Florida Clinical Research Center, LlcOrange City, Florida, United States, 32763 Clinical Neurosciences Solutions, Inc. Dba Cns HealthcareOrlando, Florida, United States, 32801 Compass Research East LlcOviedo, Florida, United States, 32765 Dmi ResearchPinellas Park, Florida, United States, 33782 Physician Care Clinical ResearchSarasota, Florida, United States, 34239|Snellville, Georgia, United States, 30078|Idaho Falls, Idaho, United States, 83404|Champaign, Illinois, United States, 61820 Northwestern UniversityChicago, Illinois, United States, 60611|Fall River, Massachusetts, United States, 02720|Saginaw, Michigan, United States, 48604|Las Vegas, Nevada, United States, 98012|Greensboro, North Carolina, United States, 27408 Pmg Research Of WilmingtonWilmington, North Carolina, United States, 28401 Unified Women'S Clinical ResearchWinston-Salem, North Carolina, United States, 27103|Cincinnati, Ohio, United States, 45212 University Of CincinnatiCincinnati, Ohio, United States, 45267 Cleveland ClinicCleveland, Ohio, United States, 44195 Amy Brenner, Md & Associates, LlcMason, Ohio, United States, 45040|Portland, Oregon, United States, 97239-3011|Jenkintown, Pennsylvania, United States, 19046 University Of PennsylvaniaPhiladelphia, Pennsylvania, United States, 19104|Columbia, South Carolina, United States, 29201|Hixon, Tennessee, United States, 37343|Beaumont, Texas, United States, 77702 Discovery Clinical TrialsDallas, Texas, United States, 75231 Advances In Health, Inc.Houston, Texas, United States, 77030 Discovery Clinical TrialsSan Antonio, Texas, United States, 78258 Center Of Reproductive MedicineWebster, Texas, United States, 77598|Norfolk, Virginia, United States, 23502|Seattle, Washington, United States, 98105","California|Florida|Georgia|Idaho|Illinois|Massachusetts|Michigan|Nevada|North Carolina|Ohio|Oregon|Pennsylvania|South Carolina|Tennessee|Texas|Virginia|Washington","Czechia|Romania|Ukraine|United States","Gynporcentrum S.R.O.|S.C. Centrul Medical De Diagn Si Tratam Ambulator Neomed Srl|City Clinical Maternity Hospital No 1|Clearview Medical Research, Llc|Women's Medical Research Group, Llc|Journey Medical Research|Women's Healthcare Associates, Pa|Women's Health Practice|New England Center For Clinical Research, Inc.|Saginaw Valley Medical Research Group, Llc|Altea Research Institute|Unified Women's Clinical Research|Cti Clinical Research Center|Oregon Health And Science University|The Clinical Trial Center, Llc|Vista Clinical Research|Chattanooga Women For Women|Gadolin Research|Tidewater Physicians For Women|Seattle Women's: Health, Research, Gynecology",{"$nulls":3},"Bayer Study Director","2018-01-15","2020-05-25T16:37:11.571","2020-05-26T17:10:42.972","NCT03400956"]
["5ecbf438feab101b155308bb","NCT03400956","2018-04-17","Bayer","BAYN","Recruiting","Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 4)","Bay-1002670|Vilaprisan","PR Modulator","Yes","['Bay-1002670', 'Vilaprisan']","No",null,"Phase 3",3,156,"Anticipated","2018-01-24","2020-04-01",{"$nulls":5},"The primary objective of this study is to show superiority of vilaprisan in the treatment of heavy menstrual bleeding (HMB) in subjects with uterine fibroids compared to placebo.\n\nThe secondary objectives of this study are to additionally evaluate the efficacy and safety of vilaprisan in subjects with uterine fibroids.",null,"A Randomized, Parallel-group, Double-blind and Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Vilaprisan in Subjects With Uterine Fibroids",15790,"Leiomyoma","Leiomyoma|Myoma","Oncology Solid Tumor","Oncology","Experimental","Vilaprisan|Placebo+Vilaprisan|Vilaprisan+Placebo","Vilaprisan: 2 treatment periods of 12 weeks, separated by 1 bleeding episode.|Placebo: 1 treatment period of 12 weeks; and Vilaprisan: 1 treatment period of 12 weeks; separated by 1 bleeding episode.|Vilaprisan: 1 treatment period of 12 weeks; and Placebo: 1 treatment period of 12 weeks; separated by 1 bleeding episode.","Drug","Vilaprisan (BAY1002670)|Placebo","Orally, coated tablet 2 mg, once daily|Orally, coated tablet, once daily",null,"Vilaprisan|Placebo+Vilaprisan|Vilaprisan+Placebo","\n\n * Women, 18 years or older in good general health\n * Diagnosis of uterine fibroid(s) documented by ultrasound at screening with at least 1 fibroid with largest diameter more than 30 mm and less than 120 mm\n * Heavy menstrual bleeding (HMB) in at least 2 bleeding periods during the screening period each with blood loss volume of >80.00 mL documented by the alkaline hematin (AH) method\n * An endometrial biopsy performed during the screening period without significant histological disorder such as endometrial hyperplasia (including simple hyperplasia) or other significant endometrial pathology\n * Use of an acceptable non-hormonal method of contraception (ie, either male condom, cap, diaphragm or sponge, each in combination with spermicide) starting at Visit 1 until the end of the study\n\n","\n\n * Pregnancy or lactation (less than 3 months since delivery, abortion, or lactation before start of treatment)\n * Hypersensitivity to any ingredient of the study drug\n * Hemoglobin values â‰¤6 g/dL or any condition requiring immediate blood transfusion (subjects with hemoglobin values â‰¤10.9 g/dL will be recommended to use iron supplementation)\n * Any diseases, conditions, or medications that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study drug\n * Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results\n * Abuse of alcohol, drugs or medicines (e.g. laxatives)\n * Use of other treatments that might interfere with the conduct of the study or the interpretation of results\n * Undiagnosed abnormal genital bleeding",{"$nulls":4},"Actual","2018-01-17","Actual","Anticipated","2020-04-01","Anticipated","2018-04-01","2018-01-05","2018-01-15","2018-04-13","No","Uterine fibroids\nHeavy menstrual bleeding","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"Female",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"2016-003561-26","EudraCT Number","Amenorrhea (yes/no)","Defined as menstrual blood loss (MBL) < 2 mL during the last 28 days of treatment","The last 28 days of treatment period 1|The last 28 days of treatment period 2","HMB response|Time to onset of amenorrhea|Time to onset of controlled bleeding|Absence of bleeding (spotting allowed)|Endometrial histology|Endometrial thickness","Defined as blood loss <80.00 mL during the last 28 days of treatment and >50% reduction compared to baseline|Onset of amenorrhea is defined by the first day for which the menstrual blood loss for all subsequent 28-day periods up to the end of the treatment period is <2 mL|Onset of controlled bleeding is defined by the first day for which the menstrual blood loss for all subsequent 28-day periods up to the end of the treatment period is <80.00 mL|Based on the UF-DBD (Uterine Fibroid Daily Bleeding Diary)|E.g. benign endometrium, presence or absence of hyperplasia or malignancy|Up to 36 weeks","The last 28 days of treatment period 1 and treatment period 2|In treatment period 1 (12 weeks) and in treatment period 2 (12 weeks)|Up to 36 weeks","clinical-trials-contact@bayer.com","Bayer Clinical Trials Contact","(+) 1-888-8422937","Krnov, Czechia, 794 01 Gynekologie Mudr. Jaromir Karban S.R.ONeratovice, Czechia, 277 11 Privatni Gynekologicko-Porodnicka OrdinacePraha, Czechia, 16000 Gynevi S.R.O.Rokycany, Czechia, 337 01 Gynekologicka AmbulanceZabreh Na Morave, Czechia, 78901|Funabashi, Chiba, Japan, 273-8588 Tsujinaka Hospital KashiwanohaKashiwa, Chiba, Japan, 277-0871 Matsudo City General HospitalMatsudo, Chiba, Japan, 270-2296|Sapporo, Hokkaido, Japan, 004-0052 Ena Odori ClinicSapporo, Hokkaido, Japan, 060-0001 Tokeidai Memorial ClinicSapporo, Hokkaido, Japan, 060-0031 Yoshio ClinicSapporo, Hokkaido, Japan, 064-0808|Kako-Gun, Hyogo, Japan, 675-1115 Kobe City Medical Center General HospitalKobe, Hyogo, Japan, 650-0047|Takamatsu, Kagawa, Japan, 760-0017 Asahi ClinicTakamatsu, Kagawa, Japan, 760-0076 Kagawa Prefectural Central HospitalTakamatsu, Kagawa, Japan, 760-8557|Fujisawa, Kanagawa, Japan, 251-0041|Nakagyo-Ku, Kyoto, Japan, 604-8845|Fukuoka, Japan, 810-0001 Unoki ClinicKagoshima, Japan, 892-0826 Tetsu-Nakamura Obstetrics And Gynecology Internal MedicineKagoshima, Japan, 892-0845 Four Seasons Ladies' ClinicKumamoto, Japan, 860-0846 Japanese Red Cross Kumamoto HospitalKumamoto, Japan, 861-8520 Ijinkai Takeda General HospitalKyoto, Japan, 601-1495 Gokeikai Osaka Kaisei HospitalOsaka, Japan, 532-0003 Osaka City Hospital Organization Osaka City General HospitalOsaka, Japan, 534-0021 Medical Co. Leading Girls Women'S Clinic Luna ShinsaibashiOsaka, Japan, 542-0086|Soka, Saitama, Japan, 340-0028|Kusatsu, Shiga, Japan, 525-8585|Brasov, Romania, 500283 S.C. Sanador SrlBucharest, Romania, 011026 S.C. Genesys Fertility Center S.R.LBucuresti, Romania, 012071 S.C. Centrul Medical Euromed S.R.LBucuresti, Romania, 020762 Spitalul Clinic Nicolae MalaxaBucuresti, Romania, 022448 Spitalul Clinic Municipal Filantropia CraiovaCraiova, Romania, 200143 Russian Federation Altai State Medical UniversityBarnaul, Russian Federation, 656038 Regional Clinical Hospital #2Krasnodar, Russian Federation, 350012 Maternity Hospital, 17Saint-Petersburg, Russian Federation, 192174 Close Joint Stock Company \"Medical Company Idk\"Samara, Russian Federation, 443067 Smolensk State Medical UniversitySmolensk, Russian Federation, 214019 Med Estetic CenterSt. Petersburg, Russian Federation, 192177 Ooo \"Granti-Med\"St. Petersburg, Russian Federation, 198329 Scien. Res. Institute Of Obsterics, Gyn. & ReproductionSt. Petersburg, Russian Federation, 199034|Chernivtsi, Ukraine, 58001 Vinnytsia City Clinical Maternity Hospital No 2Vinnytsia, Ukraine, 21001 Zaporizhzhia Regional Clinical HospitalZaporizhzhya, Ukraine, 69600|Birmingham, Alabama, United States, 35205|Canyon Country, California, United States, 91351 Diagnamics, Inc.Encinitas, California, United States, 92024 National Research InstituteHuntington Park, California, United States, 90255 Grossmont Center For Clinical ResearchLa Mesa, California, United States, 91942 West Coast Ob/Gyn AssociatesLa Mesa, California, United States, 91942 National Research InstitutePanorama City, California, United States, 91402 Artemis Institute For Clinical ResearchSan Diego, California, United States, 92103 Medical Center For Clinical ResearchSan Diego, California, United States, 92108|Clearwater, Florida, United States, 33759 Vital Pharma ResearchHialeah, Florida, United States, 33016 Solutions Through Advanced Research, Inc.Jacksonville, Florida, United States, 32256 Health Awareness, Inc.Jupiter, Florida, United States, 33458 South Florida Clinical Research InstituteMargate, Florida, United States, 33073 Savin Medical Group LlcMiami Lakes, Florida, United States, 33014 Suncoast Research Group, LlcMiami, Florida, United States, 33135 Advanced Pharma Cr, LlcMiami, Florida, United States, 33147 Genoma Research Group, Inc.Miami, Florida, United States, 33165 Florida Research Center, Inc.Miami, Florida, United States, 33174 Miami Dade Medical Research Institute, LlcMiami, Florida, United States, 33176 Vista Health ResearchMiami, Florida, United States, 33176 Palmetto Professional ResearchMiami, Florida, United States, 33186 A Premier Medical Research Of Florida, LlcOrange City, Florida, United States, 32763 Clinical Neurosciences Solutions, Inc. Dba Cns HealthcareOrlando, Florida, United States, 32801 Compass Research East LlcOviedo, Florida, United States, 32765 Dmi ResearchPinellas Park, Florida, United States, 33782 Physician Care Clinical ResearchSarasota, Florida, United States, 34239|Snellville, Georgia, United States, 30078|Idaho Falls, Idaho, United States, 83404|Champaign, Illinois, United States, 61820 Northwestern UniversityChicago, Illinois, United States, 60611|Fall River, Massachusetts, United States, 02720|Saginaw, Michigan, United States, 48604|Las Vegas, Nevada, United States, 89102|Greensboro, North Carolina, United States, 27408 Pmg Research Of WilmingtonWilmington, North Carolina, United States, 28401 Unified Women'S Clinical ResearchWinston-Salem, North Carolina, United States, 27103|Cincinnati, Ohio, United States, 45267 Cleveland ClinicCleveland, Ohio, United States, 44195 Amy Brenner, Md & Associates, LlcMason, Ohio, United States, 45040|Portland, Oregon, United States, 97239-3011|Jenkintown, Pennsylvania, United States, 19046 University Of PennsylvaniaPhiladelphia, Pennsylvania, United States, 19104|Columbia, South Carolina, United States, 29201|Hixson, Tennessee, United States, 37343|Austin, Texas, United States, 78705 Gadolin ResearchBeaumont, Texas, United States, 77702 Discovery Clinical TrialsDallas, Texas, United States, 75231 Advances In Health, Inc.Houston, Texas, United States, 77030 Discovery Clinical TrialsSan Antonio, Texas, United States, 78258 Center Of Reproductive MedicineWebster, Texas, United States, 77598|Norfolk, Virginia, United States, 23502|Seattle, Washington, United States, 98105","Alabama|California|Florida|Georgia|Idaho|Illinois|Massachusetts|Michigan|Nevada|North Carolina|Ohio|Oregon|Pennsylvania|South Carolina|Tennessee|Texas|Virginia|Washington","Czechia|Japan|Romania|Ukraine|United States","Gynporcentrum S.R.O.|Chiba Funabashi Municipal Medical Center|Hokkaido Hashimoto Clinic|Hyogo Kosumo Clinic|Kagawa Takamatsu Red Cross Hospital|Kanagawa Shonan Fujisawa Tokushukai Hospital|Kyoto Kyoto City Hospital|Saiseikai Fukuoka General Hospital|Saitama Medical Topia Soka Hospital|Shiga Kusatsu General Hospital|S.C. Centrul Medical De Diagn Si Tratam Ambulator Neomed Srl|City Clinical Maternity Hospital No 1|Central Research Associates, Inc.|Clearview Medical Research, Llc|Women's Medical Research Group, Llc|Journey Medical Research|Women's Healthcare Associates, Pa|Women's Health Practice|New England Center For Clinical Research, Inc.|Saginaw Valley Medical Research Group, Llc|Altea Research Institute|Unified Women's Clinical Research|University Of Cincinnati|Oregon Health And Science University|The Clinical Trial Center, Llc|Vista Clinical Research|Chattanooga Women For Women|Women Partners In Health Obstetrics & Gynecology (Ob/Gyn)|Tidewater Physicians For Women|Seattle Women's: Health, Research, Gynecology",{"$nulls":3},"Bayer Study Director","2018-04-13","2020-05-25T16:37:12.292","2020-05-26T17:10:42.972","NCT03400956"]
["5ecbf438307e3d1b1f8d9d1b","NCT03400956","2018-07-16","Bayer","BAYN","Recruiting","Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 4)","Bay-1002670|Vilaprisan","PR Modulator","Yes","['Bay-1002670', 'Vilaprisan']","No",null,"Phase 3",3,156,"Anticipated","2018-01-24","2020-04-01",{"$nulls":5},"The primary objective of this study is to show superiority of vilaprisan in the treatment of heavy menstrual bleeding (HMB) in subjects with uterine fibroids compared to placebo.\n\nThe secondary objectives of this study are to additionally evaluate the efficacy and safety of vilaprisan in subjects with uterine fibroids.",null,"A Randomized, Parallel-group, Double-blind and Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Vilaprisan in Subjects With Uterine Fibroids",15790,"Leiomyoma","Leiomyoma|Myoma","Oncology Solid Tumor","Oncology","Experimental","Vilaprisan|Placebo+Vilaprisan|Vilaprisan+Placebo","Vilaprisan: 2 treatment periods of 12 weeks, separated by 1 bleeding episode.|Placebo: 1 treatment period of 12 weeks; and Vilaprisan: 1 treatment period of 12 weeks; separated by 1 bleeding episode.|Vilaprisan: 1 treatment period of 12 weeks; and Placebo: 1 treatment period of 12 weeks; separated by 1 bleeding episode.","Drug","Vilaprisan (BAY1002670)|Placebo","Orally, coated tablet 2 mg, once daily|Orally, coated tablet, once daily",null,"Vilaprisan|Placebo+Vilaprisan|Vilaprisan+Placebo","\n\n * Women, 18 years or older in good general health\n * Diagnosis of uterine fibroid(s) documented by ultrasound at screening with at least 1 fibroid with largest diameter more than 30 mm and less than 120 mm\n * Heavy menstrual bleeding (HMB) in at least 2 bleeding periods during the screening period each with blood loss volume of >80.00 mL documented by the alkaline hematin (AH) method\n * An endometrial biopsy performed during the screening period without significant histological disorder such as endometrial hyperplasia (including simple hyperplasia) or other significant endometrial pathology\n * Use of an acceptable non-hormonal method of contraception (ie, either male condom, cap, diaphragm or sponge, each in combination with spermicide) starting at Visit 1 until the end of the study\n\n","\n\n * Pregnancy or lactation (less than 3 months since delivery, abortion, or lactation before start of treatment)\n * Hypersensitivity to any ingredient of the study drug\n * Hemoglobin values â‰¤6 g/dL or any condition requiring immediate blood transfusion (subjects with hemoglobin values â‰¤10.9 g/dL will be recommended to use iron supplementation)\n * Any diseases, conditions, or medications that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study drug\n * Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results\n * Abuse of alcohol, drugs or medicines (e.g. laxatives)\n * Use of other treatments that might interfere with the conduct of the study or the interpretation of results\n * Undiagnosed abnormal genital bleeding",{"$nulls":4},"Actual","2018-01-17","Actual","Anticipated","2020-04-01","Anticipated","2018-07-01","2018-01-05","2018-01-15","2018-07-13","No","Uterine fibroids\nHeavy menstrual bleeding","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"Female",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"2016-003561-26","EudraCT Number","Amenorrhea (yes/no)","Defined as menstrual blood loss (MBL) < 2 mL during the last 28 days of treatment","The last 28 days of treatment period 1|The last 28 days of treatment period 2","HMB response|Time to onset of amenorrhea|Time to onset of controlled bleeding|Absence of bleeding (spotting allowed)|Endometrial histology|Endometrial thickness","Defined as blood loss <80.00 mL during the last 28 days of treatment and >50% reduction compared to baseline|Onset of amenorrhea is defined by the first day for which the menstrual blood loss for all subsequent 28-day periods up to the end of the treatment period is <2 mL|Onset of controlled bleeding is defined by the first day for which the menstrual blood loss for all subsequent 28-day periods up to the end of the treatment period is <80.00 mL|Based on the UF-DBD (Uterine Fibroid Daily Bleeding Diary)|E.g. benign endometrium, presence or absence of hyperplasia or malignancy|Up to 36 weeks","The last 28 days of treatment period 1 and treatment period 2|In treatment period 1 (12 weeks) and in treatment period 2 (12 weeks)|Up to 36 weeks","clinical-trials-contact@bayer.com","Bayer Clinical Trials Contact","(+) 1-888-8422937","Krnov, Czechia, 794 01 Gynekologie Mudr. Jaromir Karban S.R.ONeratovice, Czechia, 277 11 Privatni Gynekologicko-Porodnicka OrdinacePraha, Czechia, 16000 Gynevi S.R.O.Rokycany, Czechia, 337 01 Gynekologicka AmbulanceZabreh Na Morave, Czechia, 78901|Funabashi, Chiba, Japan, 273-8588 Tsujinaka Hospital KashiwanohaKashiwa, Chiba, Japan, 277-0871 Matsudo City General HospitalMatsudo, Chiba, Japan, 270-2296|Sapporo, Hokkaido, Japan, 004-0052 Ena Odori ClinicSapporo, Hokkaido, Japan, 060-0001 Tokeidai Memorial ClinicSapporo, Hokkaido, Japan, 060-0031 Yoshio ClinicSapporo, Hokkaido, Japan, 064-0808|Kako-Gun, Hyogo, Japan, 675-1115 Kobe City Medical Center General HospitalKobe, Hyogo, Japan, 650-0047|Takamatsu, Kagawa, Japan, 760-0017 Asahi ClinicTakamatsu, Kagawa, Japan, 760-0076 Kagawa Prefectural Central HospitalTakamatsu, Kagawa, Japan, 760-8557|Fujisawa, Kanagawa, Japan, 251-0041|Nakagyo-Ku, Kyoto, Japan, 604-8845|Fukuoka, Japan, 810-0001 Unoki ClinicKagoshima, Japan, 892-0826 Tetsu-Nakamura Obstetrics And Gynecology Internal MedicineKagoshima, Japan, 892-0845 Four Seasons Ladies' ClinicKumamoto, Japan, 860-0846 Japanese Red Cross Kumamoto HospitalKumamoto, Japan, 861-8520 Ijinkai Takeda General HospitalKyoto, Japan, 601-1495 Japanese Red Cross Kyoto Daini HospitalKyoto, Japan, 602-8026 Gokeikai Osaka Kaisei HospitalOsaka, Japan, 532-0003 Osaka City Hospital Organization Osaka City General HospitalOsaka, Japan, 534-0021 Medical Co. Leading Girls Women'S Clinic Luna ShinsaibashiOsaka, Japan, 542-0086|Soka, Saitama, Japan, 340-0028|Kusatsu, Shiga, Japan, 525-8585|Brasov, Romania, 500283 S.C. Sanador SrlBucharest, Romania, 011026 S.C. Genesys Fertility Center S.R.LBucuresti, Romania, 012071 S.C. Centrul Medical Euromed S.R.LBucuresti, Romania, 020762 Spitalul Clinic Nicolae MalaxaBucuresti, Romania, 022448 Spitalul Clinic Municipal Filantropia CraiovaCraiova, Romania, 200143 Russian Federation Altai State Medical UniversityBarnaul, Russian Federation, 656038 Regional Clinical Hospital #2Krasnodar, Russian Federation, 350012 Maternity Hospital, 17Saint-Petersburg, Russian Federation, 192174 Close Joint Stock Company \"Medical Company Idk\"Samara, Russian Federation, 443067 Smolensk State Medical UniversitySmolensk, Russian Federation, 214019 Med Estetic CenterSt. Petersburg, Russian Federation, 192177 Ooo \"Granti-Med\"St. Petersburg, Russian Federation, 198329 Scien. Res. Institute Of Obsterics, Gyn. & ReproductionSt. Petersburg, Russian Federation, 199034|Chernivtsi, Ukraine, 58001 Vinnytsia City Clinical Maternity Hospital No 2Vinnytsia, Ukraine, 21001 Zaporizhzhia Regional Clinical HospitalZaporizhzhya, Ukraine, 69600|Birmingham, Alabama, United States, 35205|Canyon Country, California, United States, 91351 Diagnamics, Inc.Encinitas, California, United States, 92024 National Research InstituteHuntington Park, California, United States, 90255 Grossmont Center For Clinical ResearchLa Mesa, California, United States, 91942 West Coast Ob/Gyn AssociatesLa Mesa, California, United States, 91942 National Research InstitutePanorama City, California, United States, 91402 Artemis Institute For Clinical ResearchSan Diego, California, United States, 92103 Medical Center For Clinical ResearchSan Diego, California, United States, 92108|Clearwater, Florida, United States, 33759 Vital Pharma ResearchHialeah, Florida, United States, 33016 Solutions Through Advanced Research, Inc.Jacksonville, Florida, United States, 32256 Health Awareness, Inc.Jupiter, Florida, United States, 33458 South Florida Clinical Research InstituteMargate, Florida, United States, 33073 Savin Medical Group LlcMiami Lakes, Florida, United States, 33014 Suncoast Research Group, LlcMiami, Florida, United States, 33135 Advanced Pharma Cr, LlcMiami, Florida, United States, 33147 Genoma Research Group, Inc.Miami, Florida, United States, 33165 Florida Research Center, Inc.Miami, Florida, United States, 33174 Miami Dade Medical Research Institute, LlcMiami, Florida, United States, 33176 Vista Health ResearchMiami, Florida, United States, 33176 Palmetto Professional ResearchMiami, Florida, United States, 33186 A Premier Medical Research Of Florida, LlcOrange City, Florida, United States, 32763 Clinical Neurosciences Solutions, Inc. Dba Cns HealthcareOrlando, Florida, United States, 32801 Oviedo Medical Research, LlcOviedo, Florida, United States, 32765 Dmi ResearchPinellas Park, Florida, United States, 33782 Physician Care Clinical ResearchSarasota, Florida, United States, 34239|Snellville, Georgia, United States, 30078|Idaho Falls, Idaho, United States, 83404|Champaign, Illinois, United States, 61820 Northwestern UniversityChicago, Illinois, United States, 60611|Fall River, Massachusetts, United States, 02720|Saginaw, Michigan, United States, 48602|Las Vegas, Nevada, United States, 89102|Greensboro, North Carolina, United States, 27408 Nash Ob-Gyn Associates, P.A.Rocky Mount, North Carolina, United States, 27804 Pmg Research Of WilmingtonWilmington, North Carolina, United States, 28401 Unified Women'S Clinical ResearchWinston-Salem, North Carolina, United States, 27103|Cincinnati, Ohio, United States, 45267 Cleveland ClinicCleveland, Ohio, United States, 44195 Amy Brenner, Md & Associates, LlcMason, Ohio, United States, 45040|Portland, Oregon, United States, 97239-3011|Jenkintown, Pennsylvania, United States, 19046 University Of PennsylvaniaPhiladelphia, Pennsylvania, United States, 19104|Columbia, South Carolina, United States, 29201|Hixson, Tennessee, United States, 37343|Austin, Texas, United States, 78705 Gadolin ResearchBeaumont, Texas, United States, 77702 Discovery Clinical TrialsDallas, Texas, United States, 75231 Advances In Health, Inc.Houston, Texas, United States, 77030 Discovery Clinical TrialsSan Antonio, Texas, United States, 78258 Center Of Reproductive MedicineWebster, Texas, United States, 77598|Norfolk, Virginia, United States, 23502|Seattle, Washington, United States, 98105","Alabama|California|Florida|Georgia|Idaho|Illinois|Massachusetts|Michigan|Nevada|North Carolina|Ohio|Oregon|Pennsylvania|South Carolina|Tennessee|Texas|Virginia|Washington","Czechia|Japan|Romania|Ukraine|United States","Gynporcentrum S.R.O.|Chiba Funabashi Municipal Medical Center|Hokkaido Hashimoto Clinic|Hyogo Kosumo Clinic|Kagawa Takamatsu Red Cross Hospital|Kanagawa Shonan Fujisawa Tokushukai Hospital|Kyoto Kyoto City Hospital|Saiseikai Fukuoka General Hospital|Saitama Medical Topia Soka Hospital|Shiga Kusatsu General Hospital|S.C. Centrul Medical De Diagn Si Tratam Ambulator Neomed Srl|City Clinical Maternity Hospital No 1|Central Research Associates, Inc.|Clearview Medical Research, Llc|Women's Medical Research Group, Llc|Journey Medical Research|Women's Healthcare Associates, Pa|Women's Health Practice|New England Center For Clinical Research, Inc.|Great Lakes Research Group, Inc.|Altea Research Institute|Unified Women's Clinical Research|University Of Cincinnati|Oregon Health And Science University|The Clinical Trial Center, Llc|Vista Clinical Research|Chattanooga Women For Women|Women Partners In Health Obstetrics & Gynecology (Ob/Gyn)|Tidewater Physicians For Women|Seattle Women's: Health, Research, Gynecology",{"$nulls":3},"Bayer Study Director","2018-07-13","2020-05-25T16:37:12.458","2020-05-26T17:10:42.972","NCT03400956"]
["5ecbf438e2561b1b11905d86","NCT03400956","2018-09-12","Bayer","BAYN","Recruiting","Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 4)","Bay-1002670|Vilaprisan","PR Modulator","Yes","['Bay-1002670', 'Vilaprisan']","No",null,"Phase 3",3,156,"Anticipated","2018-01-24","2020-04-01",{"$nulls":5},"The primary objective of this study is to show superiority of vilaprisan in the treatment of heavy menstrual bleeding (HMB) in subjects with uterine fibroids compared to placebo.\n\nThe secondary objectives of this study are to additionally evaluate the efficacy and safety of vilaprisan in subjects with uterine fibroids.",null,"A Randomized, Parallel-group, Double-blind and Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Vilaprisan in Subjects With Uterine Fibroids",15790,"Leiomyoma","Leiomyoma|Myoma","Oncology Solid Tumor","Oncology","Experimental","Vilaprisan|Placebo+Vilaprisan|Vilaprisan+Placebo","Vilaprisan: 2 treatment periods of 12 weeks, separated by 1 bleeding episode.|Placebo: 1 treatment period of 12 weeks; and Vilaprisan: 1 treatment period of 12 weeks; separated by 1 bleeding episode.|Vilaprisan: 1 treatment period of 12 weeks; and Placebo: 1 treatment period of 12 weeks; separated by 1 bleeding episode.","Drug","Vilaprisan (BAY1002670)|Placebo","Orally, coated tablet 2 mg, once daily|Orally, coated tablet, once daily",null,"Vilaprisan|Placebo+Vilaprisan|Vilaprisan+Placebo","\n\n * Women, 18 years or older in good general health\n * Diagnosis of uterine fibroid(s) documented by ultrasound at screening with at least 1 fibroid with largest diameter more than 30 mm and less than 120 mm\n * Heavy menstrual bleeding (HMB) in at least 2 bleeding periods during the screening period each with blood loss volume of >80.00 mL documented by the alkaline hematin (AH) method\n * An endometrial biopsy performed during the screening period without significant histological disorder such as endometrial hyperplasia (including simple hyperplasia) or other significant endometrial pathology\n * Use of an acceptable non-hormonal method of contraception (ie, either male condom, cap, diaphragm or sponge, each in combination with spermicide) starting at Visit 1 until the end of the study\n\n","\n\n * Pregnancy or lactation (less than 3 months since delivery, abortion, or lactation before start of treatment)\n * Hypersensitivity to any ingredient of the study drug\n * Hemoglobin values â‰¤6 g/dL or any condition requiring immediate blood transfusion (subjects with hemoglobin values â‰¤10.9 g/dL will be recommended to use iron supplementation)\n * Any diseases, conditions, or medications that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study drug\n * Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results\n * Abuse of alcohol, drugs or medicines (e.g. laxatives)\n * Use of other treatments that might interfere with the conduct of the study or the interpretation of results\n * Undiagnosed abnormal genital bleeding",{"$nulls":4},"Actual","2018-01-17","Actual","Anticipated","2020-04-01","Anticipated","2018-09-01","2018-01-05","2018-01-15","2018-09-10","No","Uterine fibroids\nHeavy menstrual bleeding","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"Female",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"2016-003561-26","EudraCT Number","Amenorrhea (yes/no)","Defined as menstrual blood loss (MBL) < 2 mL during the last 28 days of treatment","The last 28 days of treatment period 1|The last 28 days of treatment period 2","HMB response|Time to onset of amenorrhea|Time to onset of controlled bleeding|Absence of bleeding (spotting allowed)|Endometrial histology|Endometrial thickness","Defined as blood loss <80.00 mL during the last 28 days of treatment and >50% reduction compared to baseline|Onset of amenorrhea is defined by the first day for which the menstrual blood loss for all subsequent 28-day periods up to the end of the treatment period is <2 mL|Onset of controlled bleeding is defined by the first day for which the menstrual blood loss for all subsequent 28-day periods up to the end of the treatment period is <80.00 mL|Based on the UF-DBD (Uterine Fibroid Daily Bleeding Diary)|E.g. benign endometrium, presence or absence of hyperplasia or malignancy|Up to 36 weeks","The last 28 days of treatment period 1 and treatment period 2|In treatment period 1 (12 weeks) and in treatment period 2 (12 weeks)|Up to 36 weeks","clinical-trials-contact@bayer.com","Bayer Clinical Trials Contact","(+) 1-888-8422937","Krnov, Czechia, 794 01 Gynekologie Mudr. Jaromir Karban S.R.ONeratovice, Czechia, 277 11 Privatni Gynekologicko-Porodnicka OrdinacePraha, Czechia, 16000 Gynevi S.R.O.Rokycany, Czechia, 337 01 Gynekologicka AmbulanceZabreh Na Morave, Czechia, 78901|Funabashi, Chiba, Japan, 273-8588 Tsujinaka Hospital KashiwanohaKashiwa, Chiba, Japan, 277-0871 Matsudo City General HospitalMatsudo, Chiba, Japan, 270-2296|Sapporo, Hokkaido, Japan, 004-0052 Ena Odori ClinicSapporo, Hokkaido, Japan, 060-0001 Tokeidai Memorial ClinicSapporo, Hokkaido, Japan, 060-0031 Yoshio ClinicSapporo, Hokkaido, Japan, 064-0808|Kako-Gun, Hyogo, Japan, 675-1115 Kobe City Medical Center General HospitalKobe, Hyogo, Japan, 650-0047|Takamatsu, Kagawa, Japan, 760-0017 Asahi ClinicTakamatsu, Kagawa, Japan, 760-0076 Kagawa Prefectural Central HospitalTakamatsu, Kagawa, Japan, 760-8557|Fujisawa, Kanagawa, Japan, 251-0041|Nakagyo-Ku, Kyoto, Japan, 604-8845|Fukuoka, Japan, 810-0001 Unoki ClinicKagoshima, Japan, 892-0826 Tetsu-Nakamura Obstetrics And Gynecology Internal MedicineKagoshima, Japan, 892-0845 Four Seasons Ladies' ClinicKumamoto, Japan, 860-0846 Japanese Red Cross Kumamoto HospitalKumamoto, Japan, 861-8520 Ijinkai Takeda General HospitalKyoto, Japan, 601-1495 Japanese Red Cross Kyoto Daini HospitalKyoto, Japan, 602-8026 Gokeikai Osaka Kaisei HospitalOsaka, Japan, 532-0003 Osaka City Hospital Organization Osaka City General HospitalOsaka, Japan, 534-0021 Medical Co. Leading Girls Women'S Clinic Luna ShinsaibashiOsaka, Japan, 542-0086|Soka, Saitama, Japan, 340-0028|Kusatsu, Shiga, Japan, 525-8585|Brasov, Romania, 500283 S.C. Sanador SrlBucharest, Romania, 011026 S.C. Genesys Fertility Center S.R.LBucuresti, Romania, 012071 S.C. Centrul Medical Euromed S.R.LBucuresti, Romania, 020762 Spitalul Clinic Nicolae MalaxaBucuresti, Romania, 022448 Spitalul Clinic Municipal Filantropia CraiovaCraiova, Romania, 200143 Russian Federation Altai State Medical UniversityBarnaul, Russian Federation, 656038 Regional Clinical Hospital #2Krasnodar, Russian Federation, 350012 Maternity Hospital, 17Saint-Petersburg, Russian Federation, 192174 Close Joint Stock Company \"Medical Company Idk\"Samara, Russian Federation, 443067 Smolensk State Medical UniversitySmolensk, Russian Federation, 214019 Med Estetic CenterSt. Petersburg, Russian Federation, 192177 \"Granti-Med\"St. Petersburg, Russian Federation, 198329 Scien. Res. Institute Of Obsterics, Gyn. & ReproductionSt. Petersburg, Russian Federation, 199034|Chernivtsi, Ukraine, 58001 Vinnytsia City Clinical Maternity Hospital No 2Vinnytsia, Ukraine, 21001 Zaporizhzhia Regional Clinical HospitalZaporizhzhya, Ukraine, 69600|Birmingham, Alabama, United States, 35205|Canyon Country, California, United States, 91351 Diagnamics, Inc.Encinitas, California, United States, 92024 United Clinical ResearchHuntington Beach, California, United States, 90255 National Research InstituteHuntington Park, California, United States, 90255 Grossmont Center For Clinical ResearchLa Mesa, California, United States, 91942 West Coast Ob/Gyn AssociatesLa Mesa, California, United States, 91942 National Research InstitutePanorama City, California, United States, 91402 Artemis Institute For Clinical ResearchSan Diego, California, United States, 92103 Medical Center For Clinical ResearchSan Diego, California, United States, 92108|Clearwater, Florida, United States, 33759 Vital Pharma ResearchHialeah, Florida, United States, 33016 Solutions Through Advanced Research, Inc.Jacksonville, Florida, United States, 32256 Health Awareness, Inc.Jupiter, Florida, United States, 33458 South Florida Clinical Research InstituteMargate, Florida, United States, 33073 Savin Medical Group LlcMiami Lakes, Florida, United States, 33014 Suncoast Research Group, LlcMiami, Florida, United States, 33135 Advanced Pharma Cr, LlcMiami, Florida, United States, 33147 Genoma Research Group, Inc.Miami, Florida, United States, 33165 Florida Research Center, Inc.Miami, Florida, United States, 33174 Miami Dade Medical Research Institute, LlcMiami, Florida, United States, 33176 Vista Health ResearchMiami, Florida, United States, 33176 Palmetto Professional ResearchMiami, Florida, United States, 33186 A Premier Medical Research Of Florida, LlcOrange City, Florida, United States, 32763 Clinical Neurosciences Solutions, Inc. Dba Cns HealthcareOrlando, Florida, United States, 32801 Oviedo Medical Research, LlcOviedo, Florida, United States, 32765 Dmi ResearchPinellas Park, Florida, United States, 33782 Physician Care Clinical ResearchSarasota, Florida, United States, 34239|Snellville, Georgia, United States, 30078|Idaho Falls, Idaho, United States, 83404|Champaign, Illinois, United States, 61820 Northwestern UniversityChicago, Illinois, United States, 60611|Fall River, Massachusetts, United States, 02720|Saginaw, Michigan, United States, 48602|Las Vegas, Nevada, United States, 89102|Greensboro, North Carolina, United States, 27408 Nash Ob-Gyn Associates, P.A.Rocky Mount, North Carolina, United States, 27804 Pmg Research Of WilmingtonWilmington, North Carolina, United States, 28401 Unified Women'S Clinical ResearchWinston-Salem, North Carolina, United States, 27103|Cincinnati, Ohio, United States, 45267 Cleveland ClinicCleveland, Ohio, United States, 44195 Amy Brenner, Md & Associates, LlcMason, Ohio, United States, 45040|Portland, Oregon, United States, 97239-3011|Jenkintown, Pennsylvania, United States, 19046 University Of PennsylvaniaPhiladelphia, Pennsylvania, United States, 19104|Columbia, South Carolina, United States, 29201|Hixson, Tennessee, United States, 37343|Austin, Texas, United States, 78705 Gadolin ResearchBeaumont, Texas, United States, 77702 Discovery Clinical TrialsDallas, Texas, United States, 75231 Advances In Health, Inc.Houston, Texas, United States, 77030 Discovery Clinical TrialsSan Antonio, Texas, United States, 78258 Center Of Reproductive MedicineWebster, Texas, United States, 77598|Norfolk, Virginia, United States, 23502|Seattle, Washington, United States, 98105","Alabama|California|Florida|Georgia|Idaho|Illinois|Massachusetts|Michigan|Nevada|North Carolina|Ohio|Oregon|Pennsylvania|South Carolina|Tennessee|Texas|Virginia|Washington","Czechia|Japan|Romania|Ukraine|United States","Gynporcentrum S.R.O.|Chiba Funabashi Municipal Medical Center|Hokkaido Hashimoto Clinic|Hyogo Kosumo Clinic|Kagawa Takamatsu Red Cross Hospital|Kanagawa Shonan Fujisawa Tokushukai Hospital|Kyoto Kyoto City Hospital|Saiseikai Fukuoka General Hospital|Saitama Medical Topia Soka Hospital|Shiga Kusatsu General Hospital|S.C. Centrul Medical De Diagn Si Tratam Ambulator Neomed Srl|City Clinical Maternity Hospital No 1|Central Research Associates, Inc.|Clearview Medical Research, Llc|Women's Medical Research Group, Llc|Journey Medical Research|Women's Healthcare Associates, Pa|Women's Health Practice|New England Center For Clinical Research, Inc.|Great Lakes Research Group, Inc.|Altea Research Institute|Unified Women's Clinical Research|University Of Cincinnati|Oregon Health And Science University|The Clinical Trial Center, Llc|Vista Clinical Research|Chattanooga Women For Women|Women Partners In Health Obstetrics & Gynecology (Ob/Gyn)|Tidewater Physicians For Women|Seattle Women's: Health, Research, Gynecology",{"$nulls":3},"Bayer Study Director","2018-09-10","2020-05-25T16:37:12.433","2020-05-26T17:10:42.972","NCT03400956"]
["5ecbf43811702c1b1b916a9b","NCT03400956","2018-10-11","Bayer","BAYN","Recruiting","Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 4)","Bay-1002670|Vilaprisan","PR Modulator","Yes","['Bay-1002670', 'Vilaprisan']","No",null,"Phase 3",3,156,"Anticipated","2018-01-24","2020-04-01",{"$nulls":5},"The primary objective of this study is to show superiority of vilaprisan in the treatment of heavy menstrual bleeding (HMB) in subjects with uterine fibroids compared to placebo.\n\nThe secondary objectives of this study are to additionally evaluate the efficacy and safety of vilaprisan in subjects with uterine fibroids.",null,"A Randomized, Parallel-group, Double-blind and Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Vilaprisan in Subjects With Uterine Fibroids",15790,"Leiomyoma","Leiomyoma|Myoma","Oncology Solid Tumor","Oncology","Experimental","Vilaprisan|Placebo+Vilaprisan|Vilaprisan+Placebo","Vilaprisan: 2 treatment periods of 12 weeks, separated by 1 bleeding episode.|Placebo: 1 treatment period of 12 weeks; and Vilaprisan: 1 treatment period of 12 weeks; separated by 1 bleeding episode.|Vilaprisan: 1 treatment period of 12 weeks; and Placebo: 1 treatment period of 12 weeks; separated by 1 bleeding episode.","Drug","Vilaprisan (BAY1002670)|Placebo","Orally, coated tablet 2 mg, once daily|Orally, coated tablet, once daily",null,"Vilaprisan|Placebo+Vilaprisan|Vilaprisan+Placebo","\n\n * Women, 18 years or older in good general health\n * Diagnosis of uterine fibroid(s) documented by ultrasound at screening with at least 1 fibroid with largest diameter more than 30 mm and less than 120 mm\n * Heavy menstrual bleeding (HMB) in at least 2 bleeding periods during the screening period each with blood loss volume of >80.00 mL documented by the alkaline hematin (AH) method\n * An endometrial biopsy performed during the screening period without significant histological disorder such as endometrial hyperplasia (including simple hyperplasia) or other significant endometrial pathology\n * Use of an acceptable non-hormonal method of contraception (ie, either male condom, cap, diaphragm or sponge, each in combination with spermicide) starting at Visit 1 until the end of the study\n\n","\n\n * Pregnancy or lactation (less than 3 months since delivery, abortion, or lactation before start of treatment)\n * Hypersensitivity to any ingredient of the study drug\n * Hemoglobin values â‰¤6 g/dL or any condition requiring immediate blood transfusion (subjects with hemoglobin values â‰¤10.9 g/dL will be recommended to use iron supplementation)\n * Any diseases, conditions, or medications that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study drug\n * Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results\n * Abuse of alcohol, drugs or medicines (e.g. laxatives)\n * Use of other treatments that might interfere with the conduct of the study or the interpretation of results\n * Undiagnosed abnormal genital bleeding",{"$nulls":4},"Actual","2018-01-17","Actual","Anticipated","2020-04-01","Anticipated","2018-10-01","2018-01-05","2018-01-15","2018-10-10","No","Uterine fibroids\nHeavy menstrual bleeding","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"Female",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"2016-003561-26","EudraCT Number","Amenorrhea (yes/no)","Defined as menstrual blood loss (MBL) < 2 mL during the last 28 days of treatment","The last 28 days of treatment period 1|The last 28 days of treatment period 2","HMB response|Time to onset of amenorrhea|Time to onset of controlled bleeding|Absence of bleeding (spotting allowed)|Endometrial histology|Endometrial thickness","Defined as blood loss <80.00 mL during the last 28 days of treatment and >50% reduction compared to baseline|Onset of amenorrhea is defined by the first day for which the menstrual blood loss for all subsequent 28-day periods up to the end of the treatment period is <2 mL|Onset of controlled bleeding is defined by the first day for which the menstrual blood loss for all subsequent 28-day periods up to the end of the treatment period is <80.00 mL|Based on the UF-DBD (Uterine Fibroid Daily Bleeding Diary)|E.g. benign endometrium, presence or absence of hyperplasia or malignancy|Up to 36 weeks","The last 28 days of treatment period 1 and treatment period 2|In treatment period 1 (12 weeks) and in treatment period 2 (12 weeks)|Up to 36 weeks","clinical-trials-contact@bayer.com","Bayer Clinical Trials Contact","(+) 1-888-8422937","Krnov, Czechia, 794 01 Gynekologie Mudr. Jaromir Karban S.R.ONeratovice, Czechia, 277 11 Privatni Gynekologicko-Porodnicka OrdinacePraha, Czechia, 16000 Gynevi S.R.O.Rokycany, Czechia, 337 01 Gynekologicka AmbulanceZabreh Na Morave, Czechia, 78901|Funabashi, Chiba, Japan, 273-8588 Tsujinaka Hospital KashiwanohaKashiwa, Chiba, Japan, 277-0871 Matsudo City General HospitalMatsudo, Chiba, Japan, 270-2296|Sapporo, Hokkaido, Japan, 004-0052 Ena Odori ClinicSapporo, Hokkaido, Japan, 060-0001 Tokeidai Memorial ClinicSapporo, Hokkaido, Japan, 060-0031 Yoshio ClinicSapporo, Hokkaido, Japan, 064-0808|Kako-Gun, Hyogo, Japan, 675-1115 Kobe City Medical Center General HospitalKobe, Hyogo, Japan, 650-0047|Takamatsu, Kagawa, Japan, 760-0017 Asahi ClinicTakamatsu, Kagawa, Japan, 760-0076 Kagawa Prefectural Central HospitalTakamatsu, Kagawa, Japan, 760-8557|Fujisawa, Kanagawa, Japan, 251-0041|Nakagyo-Ku, Kyoto, Japan, 604-8845|Fukuoka, Japan, 810-0001 Unoki ClinicKagoshima, Japan, 892-0826 Tetsu-Nakamura Obstetrics And Gynecology Internal MedicineKagoshima, Japan, 892-0845 Four Seasons Ladies' ClinicKumamoto, Japan, 860-0846 Japanese Red Cross Kumamoto HospitalKumamoto, Japan, 861-8520 Ijinkai Takeda General HospitalKyoto, Japan, 601-1495 Kyoto Second Red Cross HospitalKyoto, Japan, 602-8026 Gokeikai Osaka Kaisei HospitalOsaka, Japan, 532-0003 Osaka City Hospital Organization Osaka City General HospitalOsaka, Japan, 534-0021 Medical Co. Leading Girls Women'S Clinic Luna ShinsaibashiOsaka, Japan, 542-0086|Soka, Saitama, Japan, 340-0028|Kusatsu, Shiga, Japan, 525-8585|Brasov, Romania, 500283 S.C. Sanador SrlBucharest, Romania, 011026 S.C. Genesys Fertility Center S.R.LBucuresti, Romania, 012071 S.C. Centrul Medical Euromed S.R.LBucuresti, Romania, 020762 Spitalul Clinic Nicolae MalaxaBucuresti, Romania, 022448 Spitalul Clinic Municipal Filantropia CraiovaCraiova, Romania, 200143 Russian Federation Altai State Medical UniversityBarnaul, Russian Federation, 656038 Regional Clinical Hospital #2Krasnodar, Russian Federation, 350012 Maternity Hospital, 17Saint-Petersburg, Russian Federation, 192174 Close Joint Stock Company \"Medical Company Idk\"Samara, Russian Federation, 443067 Smolensk State Medical UniversitySmolensk, Russian Federation, 214019 Med Estetic CenterSt. Petersburg, Russian Federation, 192177 \"Granti-Med\"St. Petersburg, Russian Federation, 198329 Scien. Res. Institute Of Obsterics, Gyn. & ReproductionSt. Petersburg, Russian Federation, 199034|Chernivtsi, Ukraine, 58001 Vinnytsia City Clinical Maternity Hospital No 2Vinnytsia, Ukraine, 21001 Zaporizhzhia Regional Clinical HospitalZaporizhzhya, Ukraine, 69600|Birmingham, Alabama, United States, 35205|Canyon Country, California, United States, 91351 Diagnamics, Inc.Encinitas, California, United States, 92024 United Clinical ResearchHuntington Beach, California, United States, 90255 National Research InstituteHuntington Park, California, United States, 90255 Grossmont Center For Clinical ResearchLa Mesa, California, United States, 91942 West Coast Ob/Gyn AssociatesLa Mesa, California, United States, 91942 National Research InstitutePanorama City, California, United States, 91402 Artemis Institute For Clinical ResearchSan Diego, California, United States, 92103 Medical Center For Clinical ResearchSan Diego, California, United States, 92108|Clearwater, Florida, United States, 33759 Vital Pharma ResearchHialeah, Florida, United States, 33016 Solutions Through Advanced Research, Inc.Jacksonville, Florida, United States, 32256 Health Awareness, Inc.Jupiter, Florida, United States, 33458 South Florida Clinical Research InstituteMargate, Florida, United States, 33073 Savin Medical Group LlcMiami Lakes, Florida, United States, 33014 Suncoast Research Group, LlcMiami, Florida, United States, 33135 Advanced Pharma Cr, LlcMiami, Florida, United States, 33147 Genoma Research Group, Inc.Miami, Florida, United States, 33165 Florida Research Center, Inc.Miami, Florida, United States, 33174 Miami Dade Medical Research Institute, LlcMiami, Florida, United States, 33176 Vista Health ResearchMiami, Florida, United States, 33176 Palmetto Professional ResearchMiami, Florida, United States, 33186 A Premier Medical Research Of Florida, LlcOrange City, Florida, United States, 32763 Clinical Neurosciences Solutions, Inc. Dba Cns HealthcareOrlando, Florida, United States, 32801 Oviedo Medical Research, LlcOviedo, Florida, United States, 32765 Dmi ResearchPinellas Park, Florida, United States, 33782 Physician Care Clinical ResearchSarasota, Florida, United States, 34239|Snellville, Georgia, United States, 30078|Idaho Falls, Idaho, United States, 83404|Champaign, Illinois, United States, 61820 Northwestern UniversityChicago, Illinois, United States, 60611|Fall River, Massachusetts, United States, 02720|Saginaw, Michigan, United States, 48602|Las Vegas, Nevada, United States, 89102|Greensboro, North Carolina, United States, 27408 Nash Ob-Gyn Associates, P.A.Rocky Mount, North Carolina, United States, 27804 Pmg Research Of WilmingtonWilmington, North Carolina, United States, 28401 Unified Women'S Clinical ResearchWinston-Salem, North Carolina, United States, 27103|Cincinnati, Ohio, United States, 45267 Cleveland ClinicCleveland, Ohio, United States, 44195 Amy Brenner, Md & Associates, LlcMason, Ohio, United States, 45040|Portland, Oregon, United States, 97239-3011|Jenkintown, Pennsylvania, United States, 19046 University Of PennsylvaniaPhiladelphia, Pennsylvania, United States, 19104|Columbia, South Carolina, United States, 29201|Hixson, Tennessee, United States, 37343|Austin, Texas, United States, 78705 Gadolin ResearchBeaumont, Texas, United States, 77702 Discovery Clinical TrialsDallas, Texas, United States, 75231 Advances In Health, Inc.Houston, Texas, United States, 77030 Discovery Clinical TrialsSan Antonio, Texas, United States, 78258 Center Of Reproductive MedicineWebster, Texas, United States, 77598|Norfolk, Virginia, United States, 23502|Seattle, Washington, United States, 98105","Alabama|California|Florida|Georgia|Idaho|Illinois|Massachusetts|Michigan|Nevada|North Carolina|Ohio|Oregon|Pennsylvania|South Carolina|Tennessee|Texas|Virginia|Washington","Czechia|Japan|Romania|Ukraine|United States","Gynporcentrum S.R.O.|Chiba Funabashi Municipal Medical Center|Hokkaido Hashimoto Clinic|Hyogo Kosumo Clinic|Kagawa Takamatsu Red Cross Hospital|Kanagawa Shonan Fujisawa Tokushukai Hospital|Kyoto Kyoto City Hospital|Saiseikai Fukuoka General Hospital|Saitama Medical Topia Soka Hospital|Shiga Kusatsu General Hospital|S.C. Centrul Medical De Diagn Si Tratam Ambulator Neomed Srl|City Clinical Maternity Hospital No 1|Central Research Associates, Inc.|Clearview Medical Research, Llc|Women's Medical Research Group, Llc|Journey Medical Research|Women's Healthcare Associates, Pa|Women's Health Practice|New England Center For Clinical Research, Inc.|Great Lakes Research Group, Inc.|Altea Research Institute|Unified Women's Clinical Research|University Of Cincinnati|Oregon Health And Science University|The Clinical Trial Center, Llc|Vista Clinical Research|Chattanooga Women For Women|Women Partners In Health Obstetrics & Gynecology (Ob/Gyn)|Tidewater Physicians For Women|Seattle Women's: Health, Research, Gynecology",{"$nulls":3},"Bayer Study Director","2018-10-10","2020-05-25T16:37:12.439","2020-05-26T17:10:42.972","NCT03400956"]
["5ecbf438307e3d1b1f8d9d1c","NCT03400956","2019-02-05","Bayer","BAYN","Active, not recruiting","Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 4)","Bay-1002670|Vilaprisan","PR Modulator","Yes","['Bay-1002670', 'Vilaprisan']","No",null,"Phase 3",3,156,"Anticipated","2018-01-24","2020-04-01",{"$nulls":5},"The primary objective of this study is to show superiority of vilaprisan in the treatment of heavy menstrual bleeding (HMB) in subjects with uterine fibroids compared to placebo.\n\nThe secondary objectives of this study are to additionally evaluate the efficacy and safety of vilaprisan in subjects with uterine fibroids.",null,"A Randomized, Parallel-group, Double-blind and Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Vilaprisan in Subjects With Uterine Fibroids",15790,"Leiomyoma","Leiomyoma|Myoma","Oncology Solid Tumor","Oncology","Experimental","Vilaprisan|Placebo+Vilaprisan|Vilaprisan+Placebo","Vilaprisan: 2 treatment periods of 12 weeks, separated by 1 bleeding episode.|Placebo: 1 treatment period of 12 weeks; and Vilaprisan: 1 treatment period of 12 weeks; separated by 1 bleeding episode.|Vilaprisan: 1 treatment period of 12 weeks; and Placebo: 1 treatment period of 12 weeks; separated by 1 bleeding episode.","Drug","Vilaprisan (BAY1002670)|Placebo","Orally, coated tablet 2 mg, once daily|Orally, coated tablet, once daily",null,"Vilaprisan|Placebo+Vilaprisan|Vilaprisan+Placebo","\n\n * Women, 18 years or older in good general health\n * Diagnosis of uterine fibroid(s) documented by ultrasound at screening with at least 1 fibroid with largest diameter more than 30 mm and less than 120 mm\n * Heavy menstrual bleeding (HMB) in at least 2 bleeding periods during the screening period each with blood loss volume of >80.00 mL documented by the alkaline hematin (AH) method\n * An endometrial biopsy performed during the screening period without significant histological disorder such as endometrial hyperplasia (including simple hyperplasia) or other significant endometrial pathology\n * Use of an acceptable non-hormonal method of contraception (ie, either male condom, cap, diaphragm or sponge, each in combination with spermicide) starting at Visit 1 until the end of the study\n\n","\n\n * Pregnancy or lactation (less than 3 months since delivery, abortion, or lactation before start of treatment)\n * Hypersensitivity to any ingredient of the study drug\n * Hemoglobin values â‰¤6 g/dL or any condition requiring immediate blood transfusion (subjects with hemoglobin values â‰¤10.9 g/dL will be recommended to use iron supplementation)\n * Any diseases, conditions, or medications that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study drug\n * Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results\n * Abuse of alcohol, drugs or medicines (e.g. laxatives)\n * Use of other treatments that might interfere with the conduct of the study or the interpretation of results\n * Undiagnosed abnormal genital bleeding",{"$nulls":4},"Actual","2018-01-17","Actual","Anticipated","2020-04-01","Anticipated","2019-02-01","2018-01-05","2018-01-15","2019-02-04","No","Uterine fibroids\nHeavy menstrual bleeding","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"Female",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"2016-003561-26","EudraCT Number","Amenorrhea (yes/no)","Defined as menstrual blood loss (MBL) < 2 mL during the last 28 days of treatment","The last 28 days of treatment period 1|The last 28 days of treatment period 2","HMB response|Time to onset of amenorrhea|Time to onset of controlled bleeding|Absence of bleeding (spotting allowed)|Endometrial histology|Endometrial thickness","Defined as blood loss <80.00 mL during the last 28 days of treatment and >50% reduction compared to baseline|Onset of amenorrhea is defined by the first day for which the menstrual blood loss for all subsequent 28-day periods up to the end of the treatment period is <2 mL|Onset of controlled bleeding is defined by the first day for which the menstrual blood loss for all subsequent 28-day periods up to the end of the treatment period is <80.00 mL|Based on the UF-DBD (Uterine Fibroid Daily Bleeding Diary)|E.g. benign endometrium, presence or absence of hyperplasia or malignancy|Up to 36 weeks","The last 28 days of treatment period 1 and treatment period 2|In treatment period 1 (12 weeks) and in treatment period 2 (12 weeks)|Up to 36 weeks",{"$nulls":3},"Brno, Czechia, 602 00 Gynporcentrum S.R.O.Krnov, Czechia, 794 01 Gynekologie Mudr. Jaromir Karban S.R.ONeratovice, Czechia, 277 11 Privatni Gynekologicko-Porodnicka OrdinacePraha, Czechia, 16000 Gynevi S.R.O.Rokycany, Czechia, 337 01 Gynekologicka AmbulanceZabreh Na Morave, Czechia, 78901|Funabashi, Chiba, Japan, 273-8588 Tsujinaka Hospital KashiwanohaKashiwa, Chiba, Japan, 277-0871 Matsudo City General HospitalMatsudo, Chiba, Japan, 270-2296|Sapporo, Hokkaido, Japan, 004-0052 Ena Odori ClinicSapporo, Hokkaido, Japan, 060-0001 Tokeidai Memorial ClinicSapporo, Hokkaido, Japan, 060-0031 Yoshio ClinicSapporo, Hokkaido, Japan, 064-0808|Kako-Gun, Hyogo, Japan, 675-1115 Kobe City Medical Center General HospitalKobe, Hyogo, Japan, 650-0047|Takamatsu, Kagawa, Japan, 760-0017 Asahi ClinicTakamatsu, Kagawa, Japan, 760-0076 Kagawa Prefectural Central HospitalTakamatsu, Kagawa, Japan, 760-8557|Fujisawa, Kanagawa, Japan, 251-0041|Nakagyo-Ku, Kyoto, Japan, 604-8845|Fukuoka, Japan, 810-0001 Unoki ClinicKagoshima, Japan, 892-0826 Tetsu-Nakamura Obstetrics And Gynecology Internal MedicineKagoshima, Japan, 892-0845 Four Seasons Ladies' ClinicKumamoto, Japan, 860-0846 Japanese Red Cross Kumamoto HospitalKumamoto, Japan, 861-8520 Ijinkai Takeda General HospitalKyoto, Japan, 601-1495 Kyoto Second Red Cross HospitalKyoto, Japan, 602-8026 Gokeikai Osaka Kaisei HospitalOsaka, Japan, 532-0003 Osaka City Hospital Organization Osaka City General HospitalOsaka, Japan, 534-0021 Medical Co. Leading Girls Women'S Clinic Luna ShinsaibashiOsaka, Japan, 542-0086|Soka, Saitama, Japan, 340-0028|Kusatsu, Shiga, Japan, 525-8585|Brasov, Romania, 500283 S.C. Sanador SrlBucharest, Romania, 011026 S.C. Genesys Fertility Center S.R.LBucuresti, Romania, 012071 S.C. Centrul Medical Euromed S.R.LBucuresti, Romania, 020762 Spitalul Clinic Nicolae MalaxaBucuresti, Romania, 022448 Spitalul Clinic Municipal Filantropia CraiovaCraiova, Romania, 200143 Russian Federation Altai State Medical UniversityBarnaul, Russian Federation, 656038 Maternity Hospital, 17Saint-Petersburg, Russian Federation, 192174 Close Joint Stock Company \"Medical Company Idk\"Samara, Russian Federation, 443067 Smolensk State Medical UniversitySmolensk, Russian Federation, 214019 Med Estetic CenterSt. Petersburg, Russian Federation, 192177 \"Granti-Med\"St. Petersburg, Russian Federation, 198329 Scien. Res. Institute Of Obsterics, Gyn. & ReproductionSt. Petersburg, Russian Federation, 199034|Chernivtsi, Ukraine, 58001 Vinnytsia City Clinical Maternity Hospital No 2Vinnytsia, Ukraine, 21001 Zaporizhzhia Regional Clinical HospitalZaporizhzhya, Ukraine, 69600|Birmingham, Alabama, United States, 35205|Canyon Country, California, United States, 91351 Diagnamics, Inc.Encinitas, California, United States, 92024 National Research InstituteHuntington Park, California, United States, 90255 Grossmont Center For Clinical ResearchLa Mesa, California, United States, 91942 West Coast Ob/Gyn AssociatesLa Mesa, California, United States, 91942 National Research InstitutePanorama City, California, United States, 91402 Artemis Institute For Clinical ResearchSan Diego, California, United States, 92103 Medical Center For Clinical ResearchSan Diego, California, United States, 92108|Clearwater, Florida, United States, 33759 Vital Pharma ResearchHialeah, Florida, United States, 33016 Solutions Through Advanced Research, Inc.Jacksonville, Florida, United States, 32256 Health Awareness, Inc.Jupiter, Florida, United States, 33458 South Florida Clinical Research InstituteMargate, Florida, United States, 33073 Savin Medical Group LlcMiami Lakes, Florida, United States, 33014 Suncoast Research Group, LlcMiami, Florida, United States, 33135 Advanced Pharma Cr, LlcMiami, Florida, United States, 33147 Genoma Research Group, Inc.Miami, Florida, United States, 33165 Florida Research Center, Inc.Miami, Florida, United States, 33174 Miami Dade Medical Research Institute, LlcMiami, Florida, United States, 33176 Vista Health ResearchMiami, Florida, United States, 33176 Palmetto Professional ResearchMiami, Florida, United States, 33186 A Premier Medical Research Of Florida, LlcOrange City, Florida, United States, 32763 Clinical Neurosciences Solutions, Inc. Dba Cns HealthcareOrlando, Florida, United States, 32801 Oviedo Medical Research, LlcOviedo, Florida, United States, 32765 Dmi ResearchPinellas Park, Florida, United States, 33782 Physician Care Clinical ResearchSarasota, Florida, United States, 34239|Snellville, Georgia, United States, 30078|Idaho Falls, Idaho, United States, 83404|Champaign, Illinois, United States, 61820|Fall River, Massachusetts, United States, 02720|Saginaw, Michigan, United States, 48602|Las Vegas, Nevada, United States, 89102|Greensboro, North Carolina, United States, 27408 Pmg Research Of WilmingtonWilmington, North Carolina, United States, 28401 Unified Women'S Clinical ResearchWinston-Salem, North Carolina, United States, 27103|Cincinnati, Ohio, United States, 45267 Cleveland ClinicCleveland, Ohio, United States, 44195|Portland, Oregon, United States, 97239-3011|Jenkintown, Pennsylvania, United States, 19046 University Of PennsylvaniaPhiladelphia, Pennsylvania, United States, 19104|Columbia, South Carolina, United States, 29201|Hixson, Tennessee, United States, 37343|Austin, Texas, United States, 78705 Gadolin ResearchBeaumont, Texas, United States, 77702 Discovery Clinical TrialsDallas, Texas, United States, 75231 Advances In Health, Inc.Houston, Texas, United States, 77030 Discovery Clinical TrialsSan Antonio, Texas, United States, 78258 Center Of Reproductive MedicineWebster, Texas, United States, 77598|Norfolk, Virginia, United States, 23502|Seattle, Washington, United States, 98105","Alabama|California|Florida|Georgia|Idaho|Illinois|Massachusetts|Michigan|Nevada|North Carolina|Ohio|Oregon|Pennsylvania|South Carolina|Tennessee|Texas|Virginia|Washington","Czechia|Japan|Romania|Ukraine|United States","Gynekologie Meda S.R.O.|Chiba Funabashi Municipal Medical Center|Hokkaido Hashimoto Clinic|Hyogo Kosumo Clinic|Kagawa Takamatsu Red Cross Hospital|Kanagawa Shonan Fujisawa Tokushukai Hospital|Kyoto Kyoto City Hospital|Saiseikai Fukuoka General Hospital|Saitama Medical Topia Soka Hospital|Shiga Kusatsu General Hospital|S.C. Centrul Medical De Diagn Si Tratam Ambulator Neomed Srl|City Clinical Maternity Hospital No 1|Central Research Associates, Inc.|Clearview Medical Research, Llc|Women's Medical Research Group, Llc|Journey Medical Research|Women's Healthcare Associates, Pa|Women's Health Practice|New England Center For Clinical Research, Inc.|Great Lakes Research Group, Inc.|Altea Research Institute|Unified Women's Clinical Research|University Of Cincinnati|Oregon Health And Science University|The Clinical Trial Center, Llc|Vista Clinical Research|Chattanooga Women For Women|Women Partners In Health Obstetrics & Gynecology (Ob/Gyn)|Tidewater Physicians For Women|Seattle Women's: Health, Research, Gynecology",{"$nulls":3},"Bayer Study Director","2019-02-04","2020-05-25T16:37:12.522","2020-05-26T17:10:42.972","NCT03400956"]
["5ecbf438fe30261b1a04828b","NCT03400956","2019-04-05","Bayer","BAYN","Active, not recruiting","Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 4)","Bay-1002670|Vilaprisan","PR Modulator","Yes","['Bay-1002670', 'Vilaprisan']","No",null,"Phase 3",3,156,"Anticipated","2018-01-24","2020-04-01",{"$nulls":5},"The primary objective of this study is to show superiority of vilaprisan in the treatment of heavy menstrual bleeding (HMB) in subjects with uterine fibroids compared to placebo.\n\nThe secondary objectives of this study are to additionally evaluate the efficacy and safety of vilaprisan in subjects with uterine fibroids.",null,"A Randomized, Parallel-group, Double-blind and Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Vilaprisan in Subjects With Uterine Fibroids",15790,"Leiomyoma","Leiomyoma|Myoma","Oncology Solid Tumor","Oncology","Experimental","Vilaprisan|Placebo+Vilaprisan|Vilaprisan+Placebo","Vilaprisan: 2 treatment periods of 12 weeks, separated by 1 bleeding episode.|Placebo: 1 treatment period of 12 weeks; and Vilaprisan: 1 treatment period of 12 weeks; separated by 1 bleeding episode.|Vilaprisan: 1 treatment period of 12 weeks; and Placebo: 1 treatment period of 12 weeks; separated by 1 bleeding episode.","Drug","Vilaprisan (BAY1002670)|Placebo","Orally, coated tablet 2 mg, once daily|Orally, coated tablet, once daily",null,"Vilaprisan|Placebo+Vilaprisan|Vilaprisan+Placebo","\n\n * Women, 18 years or older in good general health\n * Diagnosis of uterine fibroid(s) documented by ultrasound at screening with at least 1 fibroid with largest diameter more than 30 mm and less than 120 mm\n * Heavy menstrual bleeding (HMB) in at least 2 bleeding periods during the screening period each with blood loss volume of >80.00 mL documented by the alkaline hematin (AH) method\n * An endometrial biopsy performed during the screening period without significant histological disorder such as endometrial hyperplasia (including simple hyperplasia) or other significant endometrial pathology\n * Use of an acceptable non-hormonal method of contraception (ie, either male condom, cap, diaphragm or sponge, each in combination with spermicide) starting at Visit 1 until the end of the study\n\n","\n\n * Pregnancy or lactation (less than 3 months since delivery, abortion, or lactation before start of treatment)\n * Hypersensitivity to any ingredient of the study drug\n * Hemoglobin values â‰¤6 g/dL or any condition requiring immediate blood transfusion (subjects with hemoglobin values â‰¤10.9 g/dL will be recommended to use iron supplementation)\n * Any diseases, conditions, or medications that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study drug\n * Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results\n * Abuse of alcohol, drugs or medicines (e.g. laxatives)\n * Use of other treatments that might interfere with the conduct of the study or the interpretation of results\n * Undiagnosed abnormal genital bleeding",{"$nulls":4},"Actual","2018-01-17","Actual","Anticipated","2020-04-01","Anticipated","2019-04-01","2018-01-05","2018-01-15","2019-04-04","No","Uterine fibroids\nHeavy menstrual bleeding","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"Female",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"2016-003561-26","EudraCT Number","Amenorrhea (yes/no)","Defined as menstrual blood loss (MBL) < 2 mL during the last 28 days of treatment","The last 28 days of treatment period 1|The last 28 days of treatment period 2","HMB response|Time to onset of amenorrhea|Time to onset of controlled bleeding|Absence of bleeding (spotting allowed)|Endometrial histology|Endometrial thickness","Defined as blood loss <80.00 mL during the last 28 days of treatment and >50% reduction compared to baseline|Onset of amenorrhea is defined by the first day for which the menstrual blood loss for all subsequent 28-day periods up to the end of the treatment period is <2 mL|Onset of controlled bleeding is defined by the first day for which the menstrual blood loss for all subsequent 28-day periods up to the end of the treatment period is <80.00 mL|Based on the UF-DBD (Uterine Fibroid Daily Bleeding Diary)|E.g. benign endometrium, presence or absence of hyperplasia or malignancy|Up to 36 weeks","The last 28 days of treatment period 1 and treatment period 2|In treatment period 1 (12 weeks) and in treatment period 2 (12 weeks)|Up to 36 weeks",{"$nulls":3},"Brno, Czechia, 602 00 Gynporcentrum S.R.O.Krnov, Czechia, 794 01 Gynekologie Mudr. Jaromir Karban S.R.ONeratovice, Czechia, 277 11 Privatni Gynekologicko-Porodnicka OrdinacePraha, Czechia, 16000 Gynevi S.R.O.Rokycany, Czechia, 337 01 Gynekologicka AmbulanceZabreh Na Morave, Czechia, 78901|Funabashi, Chiba, Japan, 273-8588 Tsujinaka Hospital KashiwanohaKashiwa, Chiba, Japan, 277-0871 Matsudo City General HospitalMatsudo, Chiba, Japan, 270-2296|Sapporo, Hokkaido, Japan, 004-0052 Ena Odori ClinicSapporo, Hokkaido, Japan, 060-0001 Tokeidai Memorial ClinicSapporo, Hokkaido, Japan, 060-0031 Yoshio ClinicSapporo, Hokkaido, Japan, 064-0808|Kako-Gun, Hyogo, Japan, 675-1115 Kobe City Medical Center General HospitalKobe, Hyogo, Japan, 650-0047|Takamatsu, Kagawa, Japan, 760-0017 Asahi ClinicTakamatsu, Kagawa, Japan, 760-0076 Kagawa Prefectural Central HospitalTakamatsu, Kagawa, Japan, 760-8557|Fujisawa, Kanagawa, Japan, 251-0041|Nakagyo-Ku, Kyoto, Japan, 604-8845|Fukuoka, Japan, 810-0001 Unoki ClinicKagoshima, Japan, 892-0826 Tetsu-Nakamura Obstetrics And Gynecology Internal MedicineKagoshima, Japan, 892-0845 Four Seasons Ladies' ClinicKumamoto, Japan, 860-0846 Japanese Red Cross Kumamoto HospitalKumamoto, Japan, 861-8520 Ijinkai Takeda General HospitalKyoto, Japan, 601-1495 Japanese Red Cross Kyoto Daini HospitalKyoto, Japan, 602-8026 Gokeikai Osaka Kaisei HospitalOsaka, Japan, 532-0003 Osaka City Hospital Organization Osaka City General HospitalOsaka, Japan, 534-0021 Medical Co. Leading Girls Women'S Clinic Luna ShinsaibashiOsaka, Japan, 542-0086|Soka, Saitama, Japan, 340-0028|Kusatsu, Shiga, Japan, 525-8585|Brasov, Romania, 500283 S.C. Sanador SrlBucharest, Romania, 011026 S.C. Genesys Fertility Center S.R.LBucuresti, Romania, 012071 S.C. Centrul Medical Euromed S.R.LBucuresti, Romania, 020762 Spitalul Clinic Nicolae MalaxaBucuresti, Romania, 022448 Spitalul Clinic Municipal Filantropia CraiovaCraiova, Romania, 200143 Russian Federation Altai State Medical UniversityBarnaul, Russian Federation, 656038 Maternity Hospital, 17Saint-Petersburg, Russian Federation, 192174 Close Joint Stock Company \"Medical Company Idk\"Samara, Russian Federation, 443067 Smolensk State Medical UniversitySmolensk, Russian Federation, 214019 Med Estetic CenterSt. Petersburg, Russian Federation, 192177 \"Granti-Med\"St. Petersburg, Russian Federation, 198329 Scien. Res. Institute Of Obsterics, Gyn. & ReproductionSt. Petersburg, Russian Federation, 199034|Chernivtsi, Ukraine, 58001 Vinnytsia City Clinical Maternity Hospital No 2Vinnytsia, Ukraine, 21001 Zaporizhzhia Regional Clinical HospitalZaporizhzhya, Ukraine, 69600|Birmingham, Alabama, United States, 35205|Canyon Country, California, United States, 91351 Diagnamics, Inc.Encinitas, California, United States, 92024 National Research InstituteHuntington Park, California, United States, 90255 Grossmont Center For Clinical ResearchLa Mesa, California, United States, 91942 West Coast Ob/Gyn AssociatesLa Mesa, California, United States, 91942 National Research InstitutePanorama City, California, United States, 91402 Artemis Institute For Clinical ResearchSan Diego, California, United States, 92103 Medical Center For Clinical ResearchSan Diego, California, United States, 92108|Clearwater, Florida, United States, 33759 Vital Pharma ResearchHialeah, Florida, United States, 33016 Solutions Through Advanced Research, Inc.Jacksonville, Florida, United States, 32256 Health Awareness, Inc.Jupiter, Florida, United States, 33458 South Florida Clinical Research InstituteMargate, Florida, United States, 33073 Savin Medical Group LlcMiami Lakes, Florida, United States, 33014 Suncoast Research Group, LlcMiami, Florida, United States, 33135 Advanced Pharma Cr, LlcMiami, Florida, United States, 33147 Genoma Research Group, Inc.Miami, Florida, United States, 33165 Florida Research Center, Inc.Miami, Florida, United States, 33174 Miami Dade Medical Research Institute, LlcMiami, Florida, United States, 33176 Vista Health ResearchMiami, Florida, United States, 33176 Palmetto Professional ResearchMiami, Florida, United States, 33186 A Premier Medical Research Of Florida, LlcOrange City, Florida, United States, 32763 Clinical Neurosciences Solutions, Inc. Dba Cns HealthcareOrlando, Florida, United States, 32801 Oviedo Medical Research, LlcOviedo, Florida, United States, 32765 Dmi ResearchPinellas Park, Florida, United States, 33782 Physician Care Clinical ResearchSarasota, Florida, United States, 34239|Snellville, Georgia, United States, 30078|Idaho Falls, Idaho, United States, 83404|Champaign, Illinois, United States, 61820|Fall River, Massachusetts, United States, 02720|Saginaw, Michigan, United States, 48602|Las Vegas, Nevada, United States, 89102|Greensboro, North Carolina, United States, 27408 Pmg Research Of WilmingtonWilmington, North Carolina, United States, 28401 Unified Women'S Clinical ResearchWinston-Salem, North Carolina, United States, 27103|Cincinnati, Ohio, United States, 45267 Cleveland ClinicCleveland, Ohio, United States, 44195|Portland, Oregon, United States, 97239-3011|Jenkintown, Pennsylvania, United States, 19046 University Of PennsylvaniaPhiladelphia, Pennsylvania, United States, 19104|Columbia, South Carolina, United States, 29201|Hixson, Tennessee, United States, 37343|Austin, Texas, United States, 78705 Gadolin ResearchBeaumont, Texas, United States, 77702 Discovery Clinical TrialsDallas, Texas, United States, 75231 Advances In Health, Inc.Houston, Texas, United States, 77030 Discovery Clinical TrialsSan Antonio, Texas, United States, 78258 Center Of Reproductive MedicineWebster, Texas, United States, 77598|Norfolk, Virginia, United States, 23502|Seattle, Washington, United States, 98105","Alabama|California|Florida|Georgia|Idaho|Illinois|Massachusetts|Michigan|Nevada|North Carolina|Ohio|Oregon|Pennsylvania|South Carolina|Tennessee|Texas|Virginia|Washington","Czechia|Japan|Romania|Ukraine|United States","Gynekologie Meda S.R.O.|Chiba Funabashi Municipal Medical Center|Hokkaido Hashimoto Clinic|Hyogo Kosumo Clinic|Kagawa Takamatsu Red Cross Hospital|Kanagawa Shonan Fujisawa Tokushukai Hospital|Kyoto Kyoto City Hospital|Saiseikai Fukuoka General Hospital|Saitama Medical Topia Soka Hospital|Shiga Kusatsu General Hospital|S.C. Centrul Medical De Diagn Si Tratam Ambulator Neomed Srl|City Clinical Maternity Hospital No 1|Central Research Associates, Inc.|Clearview Medical Research, Llc|Women's Medical Research Group, Llc|Journey Medical Research|Women's Healthcare Associates, Pa|Women's Health Practice|New England Center For Clinical Research, Inc.|Great Lakes Research Group, Inc.|Altea Research Institute|Unified Women's Clinical Research|University Of Cincinnati|Oregon Health And Science University|The Clinical Trial Center, Llc|Vista Clinical Research|Chattanooga Women For Women|Women Partners In Health Obstetrics & Gynecology (Ob/Gyn)|Tidewater Physicians For Women|Seattle Women's: Health, Research, Gynecology",{"$nulls":3},"Bayer Study Director","2019-04-04","2020-05-25T16:37:12.827","2020-05-26T17:10:42.972","NCT03400956"]
["5ecbf439307e3d1b1f8d9d1d","NCT03400956","2019-07-01","Bayer","BAYN","Active, not recruiting","Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 4)","Bay-1002670|Vilaprisan","PR Modulator","Yes","['Bay-1002670', 'Vilaprisan']","No",null,"Phase 3",3,156,"Anticipated","2018-01-24","2020-04-01",{"$nulls":5},"The primary objective of this study is to show superiority of vilaprisan in the treatment of heavy menstrual bleeding (HMB) in subjects with uterine fibroids compared to placebo\n\nThe secondary objectives of this study are to additionally evaluate the efficacy and safety of vilaprisan in subjects with uterine fibroids",null,"A Randomized, Parallel-group, Double-blind and Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Vilaprisan in Subjects With Uterine Fibroids",15790,"Leiomyoma","Leiomyoma|Myoma","Oncology Solid Tumor","Oncology","Experimental","Vilaprisan|Placebo+Vilaprisan|Vilaprisan+Placebo","Vilaprisan: 2 treatment periods of 12 weeks, separated by 1 bleeding episode.|Placebo: 1 treatment period of 12 weeks; and Vilaprisan: 1 treatment period of 12 weeks; separated by 1 bleeding episode.|Vilaprisan: 1 treatment period of 12 weeks; and Placebo: 1 treatment period of 12 weeks; separated by 1 bleeding episode.","Drug","Vilaprisan (BAY1002670)|Placebo","Orally, coated tablet 2 mg, once daily|Orally, coated tablet, once daily",null,"Vilaprisan|Placebo+Vilaprisan|Vilaprisan+Placebo","\n\n * Women, 18 years or older in good general health\n * Diagnosis of uterine fibroid(s) documented by ultrasound at screening with at least 1 fibroid with largest diameter more than 30 mm and less than 120 mm\n * Heavy menstrual bleeding (HMB) in at least 2 bleeding periods during the screening period each with blood loss volume of >80.00 mL documented by the alkaline hematin (AH) method\n * An endometrial biopsy performed during the screening period without significant histological disorder such as endometrial hyperplasia (including simple hyperplasia) or other significant endometrial pathology\n * Use of an acceptable non-hormonal method of contraception (ie, either male condom, cap, diaphragm or sponge, each in combination with spermicide) starting at Visit 1 until the end of the study\n\n","\n\n * Pregnancy or lactation (less than 3 months since delivery, abortion, or lactation before start of treatment)\n * Hypersensitivity to any ingredient of the study drug\n * Hemoglobin values â‰¤6 g/dL or any condition requiring immediate blood transfusion (subjects with hemoglobin values â‰¤10.9 g/dL will be recommended to use iron supplementation)\n * Any diseases, conditions, or medications that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study drug\n * Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results\n * Abuse of alcohol, drugs or medicines (e.g. laxatives)\n * Use of other treatments that might interfere with the conduct of the study or the interpretation of results\n * Undiagnosed abnormal genital bleeding",{"$nulls":4},"Actual","2018-01-17","Actual","Anticipated","2020-04-01","Anticipated","2019-06-01","2018-01-05","2018-01-15","2019-06-28","No","Uterine fibroids\nHeavy menstrual bleeding","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"Female",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"2016-003561-26","EudraCT Number","Amenorrhea (yes/no)","Defined as menstrual blood loss (MBL) < 2 mL during the last 28 days of treatment","The last 28 days of treatment period 1|The last 28 days of treatment period 2","HMB response|Time to onset of amenorrhea|Time to onset of controlled bleeding|Absence of bleeding (spotting allowed)|Endometrial histology|Endometrial thickness","Defined as blood loss <80.00 mL during the last 28 days of treatment and >50% reduction compared to baseline|Onset of amenorrhea is defined by the first day for which the menstrual blood loss for all subsequent 28-day periods up to the end of the treatment period is <2 mL|Onset of controlled bleeding is defined by the first day for which the menstrual blood loss for all subsequent 28-day periods up to the end of the treatment period is <80.00 mL|Based on the UF-DBD (Uterine Fibroid Daily Bleeding Diary)|E.g. benign endometrium, presence or absence of hyperplasia or malignancy|Up to 36 weeks","The last 28 days of treatment period 1 and treatment period 2|In treatment period 1 (12 weeks) and in treatment period 2 (12 weeks)|Up to 36 weeks",{"$nulls":3},"Brno, Czechia, 602 00 Gynporcentrum S.R.O.Krnov, Czechia, 794 01 Gynekologie Mudr. Jaromir Karban S.R.ONeratovice, Czechia, 277 11 Privatni Gynekologicko-Porodnicka OrdinacePraha, Czechia, 16000 Gynevi S.R.O.Rokycany, Czechia, 337 01 Gynekologicka AmbulanceZabreh Na Morave, Czechia, 78901|Funabashi, Chiba, Japan, 273-8588 Tsujinaka Hospital KashiwanohaKashiwa, Chiba, Japan, 277-0871 Matsudo City General HospitalMatsudo, Chiba, Japan, 270-2296|Sapporo, Hokkaido, Japan, 004-0052 Ena Odori ClinicSapporo, Hokkaido, Japan, 060-0001 Tokeidai Memorial ClinicSapporo, Hokkaido, Japan, 060-0031 Yoshio ClinicSapporo, Hokkaido, Japan, 064-0808|Kako-Gun, Hyogo, Japan, 675-1115 Kobe City Medical Center General HospitalKobe, Hyogo, Japan, 650-0047|Takamatsu, Kagawa, Japan, 760-0017 Asahi ClinicTakamatsu, Kagawa, Japan, 760-0076 Kagawa Prefectural Central HospitalTakamatsu, Kagawa, Japan, 760-8557|Fujisawa, Kanagawa, Japan, 251-0041|Nakagyo-Ku, Kyoto, Japan, 604-8845|Fukuoka, Japan, 810-0001 Unoki ClinicKagoshima, Japan, 892-0826 Tetsu-Nakamura Obstetrics And Gynecology Internal MedicineKagoshima, Japan, 892-0845 Four Seasons Ladies' ClinicKumamoto, Japan, 860-0846 Japanese Red Cross Kumamoto HospitalKumamoto, Japan, 861-8520 Ijinkai Takeda General HospitalKyoto, Japan, 601-1495 Japanese Red Cross Kyoto Daini HospitalKyoto, Japan, 602-8026 Gokeikai Osaka Kaisei HospitalOsaka, Japan, 532-0003 Osaka City Hospital Organization Osaka City General HospitalOsaka, Japan, 534-0021 Medical Co. Leading Girls Women'S Clinic Luna ShinsaibashiOsaka, Japan, 542-0086|Soka, Saitama, Japan, 340-0028|Kusatsu, Shiga, Japan, 525-8585|Brasov, Romania, 500283 S.C. Sanador SrlBucharest, Romania, 011026 S.C. Genesys Fertility Center S.R.LBucuresti, Romania, 012071 S.C. Centrul Medical Euromed S.R.LBucuresti, Romania, 020762 Spitalul Clinic Nicolae MalaxaBucuresti, Romania, 022448 Spitalul Clinic Municipal Filantropia CraiovaCraiova, Romania, 200143 Russian Federation Altai State Medical UniversityBarnaul, Russian Federation, 656038 Maternity Hospital, 17Saint-Petersburg, Russian Federation, 192174 Close Joint Stock Company \"Medical Company Idk\"Samara, Russian Federation, 443067 Smolensk State Medical UniversitySmolensk, Russian Federation, 214019 Med Estetic CenterSt. Petersburg, Russian Federation, 192177 \"Granti-Med\"St. Petersburg, Russian Federation, 198329 Scien. Res. Institute Of Obsterics, Gyn. & ReproductionSt. Petersburg, Russian Federation, 199034|Chernivtsi, Ukraine, 58001 Vinnytsia City Clinical Maternity Hospital No 2Vinnytsia, Ukraine, 21001 Zaporizhzhia Regional Clinical HospitalZaporizhzhya, Ukraine, 69600|Birmingham, Alabama, United States, 35205|Canyon Country, California, United States, 91351 Diagnamics, Inc.Encinitas, California, United States, 92024 National Research InstituteHuntington Park, California, United States, 90255 Grossmont Center For Clinical ResearchLa Mesa, California, United States, 91942 West Coast Ob/Gyn AssociatesLa Mesa, California, United States, 91942 National Research InstitutePanorama City, California, United States, 91402 Artemis Institute For Clinical ResearchSan Diego, California, United States, 92103 Medical Center For Clinical ResearchSan Diego, California, United States, 92108|Clearwater, Florida, United States, 33759 Vital Pharma ResearchHialeah, Florida, United States, 33016 Solutions Through Advanced Research, Inc.Jacksonville, Florida, United States, 32256 Health Awareness, Inc.Jupiter, Florida, United States, 33458 South Florida Clinical Research InstituteMargate, Florida, United States, 33073 Savin Medical Group LlcMiami Lakes, Florida, United States, 33014 Suncoast Research Group, LlcMiami, Florida, United States, 33135 Advanced Pharma Cr, LlcMiami, Florida, United States, 33147 Genoma Research Group, Inc.Miami, Florida, United States, 33165 Florida Research Center, Inc.Miami, Florida, United States, 33174 Miami Dade Medical Research Institute, LlcMiami, Florida, United States, 33176 Vista Health ResearchMiami, Florida, United States, 33176 Palmetto Professional ResearchMiami, Florida, United States, 33186 A Premier Medical Research Of Florida, LlcOrange City, Florida, United States, 32763 Clinical Neurosciences Solutions, Inc. Dba Cns HealthcareOrlando, Florida, United States, 32801 Oviedo Medical Research, LlcOviedo, Florida, United States, 32765 Dmi ResearchPinellas Park, Florida, United States, 33782 Physician Care Clinical ResearchSarasota, Florida, United States, 34239|Snellville, Georgia, United States, 30078|Idaho Falls, Idaho, United States, 83404|Champaign, Illinois, United States, 61820|Fall River, Massachusetts, United States, 02720|Saginaw, Michigan, United States, 48602|Las Vegas, Nevada, United States, 89102|Greensboro, North Carolina, United States, 27408 Pmg Research Of WilmingtonWilmington, North Carolina, United States, 28401 Unified Women'S Clinical ResearchWinston-Salem, North Carolina, United States, 27103|Cincinnati, Ohio, United States, 45267 Cleveland ClinicCleveland, Ohio, United States, 44195|Portland, Oregon, United States, 97239-3011|Jenkintown, Pennsylvania, United States, 19046 University Of PennsylvaniaPhiladelphia, Pennsylvania, United States, 19104|Columbia, South Carolina, United States, 29201|Hixson, Tennessee, United States, 37343|Austin, Texas, United States, 78705 Gadolin ResearchBeaumont, Texas, United States, 77702 Discovery Clinical TrialsDallas, Texas, United States, 75231 Advances In Health, Inc.Houston, Texas, United States, 77030 Discovery Clinical TrialsSan Antonio, Texas, United States, 78258 Center Of Reproductive MedicineWebster, Texas, United States, 77598|Norfolk, Virginia, United States, 23502|Seattle, Washington, United States, 98105","Alabama|California|Florida|Georgia|Idaho|Illinois|Massachusetts|Michigan|Nevada|North Carolina|Ohio|Oregon|Pennsylvania|South Carolina|Tennessee|Texas|Virginia|Washington","Czechia|Japan|Romania|Ukraine|United States","Gynekologie Meda S.R.O.|Chiba Funabashi Municipal Medical Center|Hokkaido Hashimoto Clinic|Hyogo Kosumo Clinic|Kagawa Takamatsu Red Cross Hospital|Kanagawa Shonan Fujisawa Tokushukai Hospital|Kyoto Kyoto City Hospital|Saiseikai Fukuoka General Hospital|Saitama Medical Topia Soka Hospital|Shiga Kusatsu General Hospital|S.C. Centrul Medical De Diagn Si Tratam Ambulator Neomed Srl|City Clinical Maternity Hospital No 1|Central Research Associates, Inc.|Clearview Medical Research, Llc|Women's Medical Research Group, Llc|Journey Medical Research|Women's Healthcare Associates, Pa|Women's Health Practice|New England Center For Clinical Research, Inc.|Great Lakes Research Group, Inc.|Altea Research Institute|Unified Women's Clinical Research|University Of Cincinnati|Oregon Health And Science University|The Clinical Trial Center, Llc|Vista Clinical Research|Chattanooga Women For Women|Women Partners In Health Obstetrics & Gynecology (Ob/Gyn)|Tidewater Physicians For Women|Seattle Women's: Health, Research, Gynecology",{"$nulls":3},"Bayer Study Director","2019-06-28","2020-05-25T16:37:13.429","2020-05-26T17:10:42.972","NCT03400956"]
["5ecbf439307e3d1b1f8d9d1e","NCT03400956","2019-09-26","Bayer","BAYN","Active, not recruiting","Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 4)","Bay-1002670|Vilaprisan","PR Modulator","Yes","['Bay-1002670', 'Vilaprisan']","No",null,"Phase 3",3,156,"Anticipated","2018-01-24","2021-11-13",{"$nulls":5},"The primary objective of this study is to show superiority of vilaprisan in the treatment of heavy menstrual bleeding (HMB) in subjects with uterine fibroids compared to placebo\n\nThe secondary objectives of this study are to additionally evaluate the efficacy and safety of vilaprisan in subjects with uterine fibroids",null,"A Randomized, Parallel-group, Double-blind and Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Vilaprisan in Subjects With Uterine Fibroids",15790,"Leiomyoma","Leiomyoma|Myoma","Oncology Solid Tumor","Oncology","Experimental","Vilaprisan|Placebo+Vilaprisan|Vilaprisan+Placebo","Vilaprisan: 2 treatment periods of 12 weeks, separated by 1 bleeding episode.|Placebo: 1 treatment period of 12 weeks; and Vilaprisan: 1 treatment period of 12 weeks; separated by 1 bleeding episode.|Vilaprisan: 1 treatment period of 12 weeks; and Placebo: 1 treatment period of 12 weeks; separated by 1 bleeding episode.","Drug","Vilaprisan (BAY1002670)|Placebo","Orally, coated tablet 2 mg, once daily|Orally, coated tablet, once daily",null,"Vilaprisan|Placebo+Vilaprisan|Vilaprisan+Placebo","\n\n * Women, 18 years or older in good general health\n * Diagnosis of uterine fibroid(s) documented by ultrasound at screening with at least 1 fibroid with largest diameter more than 30 mm and less than 120 mm\n * Heavy menstrual bleeding (HMB) in at least 2 bleeding periods during the screening period each with blood loss volume of >80.00 mL documented by the alkaline hematin (AH) method\n * An endometrial biopsy performed during the screening period without significant histological disorder such as endometrial hyperplasia (including simple hyperplasia) or other significant endometrial pathology\n * Use of an acceptable non-hormonal method of contraception (ie, either male condom, cap, diaphragm or sponge, each in combination with spermicide) starting at Visit 1 until the end of the study\n\n","\n\n * Pregnancy or lactation (less than 3 months since delivery, abortion, or lactation before start of treatment)\n * Hypersensitivity to any ingredient of the study drug\n * Hemoglobin values â‰¤6 g/dL or any condition requiring immediate blood transfusion (subjects with hemoglobin values â‰¤10.9 g/dL will be recommended to use iron supplementation)\n * Any diseases, conditions, or medications that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study drug\n * Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results\n * Abuse of alcohol, drugs or medicines (e.g. laxatives)\n * Use of other treatments that might interfere with the conduct of the study or the interpretation of results\n * Undiagnosed abnormal genital bleeding",{"$nulls":4},"Actual","2018-01-17","Actual","Anticipated","2021-11-13","Anticipated","2019-09-01","2018-01-05","2018-01-15","2019-09-25","No","Uterine fibroids\nHeavy menstrual bleeding","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"Female",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"2016-003561-26","EudraCT Number","Amenorrhea (yes/no)","Defined as menstrual blood loss (MBL) < 2 mL during the last 28 days of treatment","The last 28 days of treatment period 1|The last 28 days of treatment period 2","HMB response|Time to onset of amenorrhea|Time to onset of controlled bleeding|Absence of bleeding (spotting allowed)|Endometrial histology|Endometrial thickness","Defined as blood loss <80.00 mL during the last 28 days of treatment and >50% reduction compared to baseline|Onset of amenorrhea is defined by the first day for which the menstrual blood loss for all subsequent 28-day periods up to the end of the treatment period is <2 mL|Onset of controlled bleeding is defined by the first day for which the menstrual blood loss for all subsequent 28-day periods up to the end of the treatment period is <80.00 mL|Based on the UF-DBD (Uterine Fibroid Daily Bleeding Diary)|E.g. benign endometrium, presence or absence of hyperplasia or malignancy|Up to 36 weeks","The last 28 days of treatment period 1 and treatment period 2|In treatment period 1 (12 weeks) and in treatment period 2 (12 weeks)|Up to 36 weeks",{"$nulls":3},"Brno, Czechia, 602 00 Gynporcentrum S.R.O.Krnov, Czechia, 794 01 Gynekologie Mudr. Jaromir Karban S.R.ONeratovice, Czechia, 277 11 Privatni Gynekologicko-Porodnicka OrdinacePraha, Czechia, 16000 Gynevi S.R.O.Rokycany, Czechia, 337 01 Gynekologicka AmbulanceZabreh Na Morave, Czechia, 78901|Funabashi, Chiba, Japan, 273-8588 Tsujinaka Hospital KashiwanohaKashiwa, Chiba, Japan, 277-0871 Matsudo City General HospitalMatsudo, Chiba, Japan, 270-2296|Sapporo, Hokkaido, Japan, 004-0052 Ena Odori ClinicSapporo, Hokkaido, Japan, 060-0001 Tokeidai Memorial ClinicSapporo, Hokkaido, Japan, 060-0031 Yoshio ClinicSapporo, Hokkaido, Japan, 064-0808|Kako-Gun, Hyogo, Japan, 675-1115 Kobe City Medical Center General HospitalKobe, Hyogo, Japan, 650-0047|Takamatsu, Kagawa, Japan, 760-0017 Asahi ClinicTakamatsu, Kagawa, Japan, 760-0076 Kagawa Prefectural Central HospitalTakamatsu, Kagawa, Japan, 760-8557|Fujisawa, Kanagawa, Japan, 251-0041|Nakagyo-Ku, Kyoto, Japan, 604-8845|Fukuoka, Japan, 810-0001 Unoki ClinicKagoshima, Japan, 892-0826 Tetsu-Nakamura Obstetrics And Gynecology Internal MedicineKagoshima, Japan, 892-0845 Four Seasons Ladies' ClinicKumamoto, Japan, 860-0846 Japanese Red Cross Kumamoto HospitalKumamoto, Japan, 861-8520 Ijinkai Takeda General HospitalKyoto, Japan, 601-1495 Japanese Red Cross Kyoto Daini HospitalKyoto, Japan, 602-8026 Gokeikai Osaka Kaisei HospitalOsaka, Japan, 532-0003 Osaka City Hospital Organization Osaka City General HospitalOsaka, Japan, 534-0021 Medical Co. Leading Girls Women'S Clinic Luna ShinsaibashiOsaka, Japan, 542-0086|Soka, Saitama, Japan, 340-0028|Kusatsu, Shiga, Japan, 525-8585|Brasov, Romania, 500283 S.C. Sanador SrlBucharest, Romania, 011026 S.C. Genesys Fertility Center S.R.LBucuresti, Romania, 012071 S.C. Centrul Medical Euromed S.R.LBucuresti, Romania, 020762 Spitalul Clinic Nicolae MalaxaBucuresti, Romania, 022448 Spitalul Clinic Municipal Filantropia CraiovaCraiova, Romania, 200143 Russian Federation Altai State Medical UniversityBarnaul, Russian Federation, 656038 Maternity Hospital, 17Saint-Petersburg, Russian Federation, 192174 Close Joint Stock Company \"Medical Company Idk\"Samara, Russian Federation, 443067 Smolensk State Medical UniversitySmolensk, Russian Federation, 214019 Med Estetic CenterSt. Petersburg, Russian Federation, 192177 \"Granti-Med\"St. Petersburg, Russian Federation, 198329 Scien. Res. Institute Of Obsterics, Gyn. & ReproductionSt. Petersburg, Russian Federation, 199034|Chernivtsi, Ukraine, 58001 Vinnytsia City Clinical Maternity Hospital No 2Vinnytsia, Ukraine, 21001 Zaporizhzhia Regional Clinical HospitalZaporizhzhya, Ukraine, 69600|Birmingham, Alabama, United States, 35205|Canyon Country, California, United States, 91351 Diagnamics, Inc.Encinitas, California, United States, 92024 National Research InstituteHuntington Park, California, United States, 90255 Grossmont Center For Clinical ResearchLa Mesa, California, United States, 91942 West Coast Ob/Gyn AssociatesLa Mesa, California, United States, 91942 National Research InstitutePanorama City, California, United States, 91402 Artemis Institute For Clinical ResearchSan Diego, California, United States, 92103 Medical Center For Clinical ResearchSan Diego, California, United States, 92108|Clearwater, Florida, United States, 33759 Vital Pharma ResearchHialeah, Florida, United States, 33016 Solutions Through Advanced Research, Inc.Jacksonville, Florida, United States, 32256 Health Awareness, Inc.Jupiter, Florida, United States, 33458 South Florida Clinical Research InstituteMargate, Florida, United States, 33073 Savin Medical Group LlcMiami Lakes, Florida, United States, 33014 Suncoast Research Group, LlcMiami, Florida, United States, 33135 Advanced Pharma Cr, LlcMiami, Florida, United States, 33147 Genoma Research Group, Inc.Miami, Florida, United States, 33165 Florida Research Center, Inc.Miami, Florida, United States, 33174 Miami Dade Medical Research Institute, LlcMiami, Florida, United States, 33176 Vista Health ResearchMiami, Florida, United States, 33176 Palmetto Professional ResearchMiami, Florida, United States, 33186 A Premier Medical Research Of Florida, LlcOrange City, Florida, United States, 32763 Clinical Neurosciences Solutions, Inc. Dba Cns HealthcareOrlando, Florida, United States, 32801 Oviedo Medical Research, LlcOviedo, Florida, United States, 32765 Dmi ResearchPinellas Park, Florida, United States, 33782 Physician Care Clinical ResearchSarasota, Florida, United States, 34239|Snellville, Georgia, United States, 30078|Idaho Falls, Idaho, United States, 83404|Champaign, Illinois, United States, 61820|Fall River, Massachusetts, United States, 02720|Saginaw, Michigan, United States, 48602|Las Vegas, Nevada, United States, 89102|Greensboro, North Carolina, United States, 27408 Pmg Research Of WilmingtonWilmington, North Carolina, United States, 28401 Unified Women'S Clinical ResearchWinston-Salem, North Carolina, United States, 27103|Cincinnati, Ohio, United States, 45267|Portland, Oregon, United States, 97239-3011|Jenkintown, Pennsylvania, United States, 19046 University Of PennsylvaniaPhiladelphia, Pennsylvania, United States, 19104|Columbia, South Carolina, United States, 29201|Hixson, Tennessee, United States, 37343|Austin, Texas, United States, 78705 Gadolin ResearchBeaumont, Texas, United States, 77702 Discovery Clinical TrialsDallas, Texas, United States, 75231 Advances In Health, Inc.Houston, Texas, United States, 77030 Discovery Clinical TrialsSan Antonio, Texas, United States, 78258 Center Of Reproductive MedicineWebster, Texas, United States, 77598|Norfolk, Virginia, United States, 23502|Seattle, Washington, United States, 98105","Alabama|California|Florida|Georgia|Idaho|Illinois|Massachusetts|Michigan|Nevada|North Carolina|Ohio|Oregon|Pennsylvania|South Carolina|Tennessee|Texas|Virginia|Washington","Czechia|Japan|Romania|Ukraine|United States","Gynekologie Meda S.R.O.|Chiba Funabashi Municipal Medical Center|Hokkaido Hashimoto Clinic|Hyogo Kosumo Clinic|Kagawa Takamatsu Red Cross Hospital|Kanagawa Shonan Fujisawa Tokushukai Hospital|Kyoto Kyoto City Hospital|Saiseikai Fukuoka General Hospital|Saitama Medical Topia Soka Hospital|Shiga Kusatsu General Hospital|S.C. Centrul Medical De Diagn Si Tratam Ambulator Neomed Srl|City Clinical Maternity Hospital No 1|Central Research Associates, Inc.|Clearview Medical Research, Llc|Women's Medical Research Group, Llc|Journey Medical Research|Women's Healthcare Associates, Pa|Women's Health Practice|New England Center For Clinical Research, Inc.|Great Lakes Research Group, Inc.|Altea Research Institute|Unified Women's Clinical Research|University Of Cincinnati|Oregon Health And Science University|The Clinical Trial Center, Llc|Vista Clinical Research|Chattanooga Women For Women|Women Partners In Health Obstetrics & Gynecology (Ob/Gyn)|Tidewater Physicians For Women|Seattle Women's: Health, Research, Gynecology",{"$nulls":3},"Bayer Study Director","2019-09-25","2020-05-25T16:37:13.637","2020-05-26T17:10:42.972","NCT03400956"]
["5ecbf43911702c1b1b916a9d","NCT03400956","2019-11-26","Bayer","BAYN","Active, not recruiting","Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 4)","Bay-1002670|Vilaprisan","PR Modulator","Yes","['Bay-1002670', 'Vilaprisan']","No",null,"Phase 3",3,156,"Anticipated","2018-01-24","2020-12-31",{"$nulls":5},"The primary objective of this study is to show superiority of vilaprisan in the treatment of heavy menstrual bleeding (HMB) in subjects with uterine fibroids compared to placebo\n\nThe secondary objectives of this study are to additionally evaluate the efficacy and safety of vilaprisan in subjects with uterine fibroids",null,"A Randomized, Parallel-group, Double-blind and Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Vilaprisan in Subjects With Uterine Fibroids",15790,"Leiomyoma","Leiomyoma|Myoma","Oncology Solid Tumor","Oncology","Experimental","Vilaprisan|Placebo+Vilaprisan|Vilaprisan+Placebo","Vilaprisan: 2 treatment periods of 12 weeks, separated by 1 bleeding episode.|Placebo: 1 treatment period of 12 weeks; and Vilaprisan: 1 treatment period of 12 weeks; separated by 1 bleeding episode.|Vilaprisan: 1 treatment period of 12 weeks; and Placebo: 1 treatment period of 12 weeks; separated by 1 bleeding episode.","Drug","Vilaprisan (BAY1002670)|Placebo","Orally, coated tablet 2 mg, once daily|Orally, coated tablet, once daily",null,"Vilaprisan|Placebo+Vilaprisan|Vilaprisan+Placebo","\n\n * Women, 18 years or older in good general health\n * Diagnosis of uterine fibroid(s) documented by ultrasound at screening with at least 1 fibroid with largest diameter more than 30 mm and less than 120 mm\n * Heavy menstrual bleeding (HMB) in at least 2 bleeding periods during the screening period each with blood loss volume of >80.00 mL documented by the alkaline hematin (AH) method\n * An endometrial biopsy performed during the screening period without significant histological disorder such as endometrial hyperplasia (including simple hyperplasia) or other significant endometrial pathology\n * Use of an acceptable non-hormonal method of contraception (ie, either male condom, cap, diaphragm or sponge, each in combination with spermicide) starting at Visit 1 until the end of the study\n\n","\n\n * Pregnancy or lactation (less than 3 months since delivery, abortion, or lactation before start of treatment)\n * Hypersensitivity to any ingredient of the study drug\n * Hemoglobin values â‰¤6 g/dL or any condition requiring immediate blood transfusion (subjects with hemoglobin values â‰¤10.9 g/dL will be recommended to use iron supplementation)\n * Any diseases, conditions, or medications that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study drug\n * Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results\n * Abuse of alcohol, drugs or medicines (e.g. laxatives)\n * Use of other treatments that might interfere with the conduct of the study or the interpretation of results\n * Undiagnosed abnormal genital bleeding",{"$nulls":4},"Actual","2018-01-17","Actual","Anticipated","2020-12-31","Anticipated","2019-11-01","2018-01-05","2018-01-15","2019-11-25","No","Uterine fibroids\nHeavy menstrual bleeding","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"Female",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"2016-003561-26","EudraCT Number","Amenorrhea (yes/no)","Defined as menstrual blood loss (MBL) < 2 mL during the last 28 days of treatment","The last 28 days of treatment period 1|The last 28 days of treatment period 2","HMB response|Time to onset of amenorrhea|Time to onset of controlled bleeding|Absence of bleeding (spotting allowed)|Endometrial histology|Endometrial thickness","Defined as blood loss <80.00 mL during the last 28 days of treatment and >50% reduction compared to baseline|Onset of amenorrhea is defined by the first day for which the menstrual blood loss for all subsequent 28-day periods up to the end of the treatment period is <2 mL|Onset of controlled bleeding is defined by the first day for which the menstrual blood loss for all subsequent 28-day periods up to the end of the treatment period is <80.00 mL|Based on the UF-DBD (Uterine Fibroid Daily Bleeding Diary)|E.g. benign endometrium, presence or absence of hyperplasia or malignancy|Up to 36 weeks","The last 28 days of treatment period 1 and treatment period 2|In treatment period 1 (12 weeks) and in treatment period 2 (12 weeks)|Up to 36 weeks",{"$nulls":3},"Krnov, Czechia, 794 01 Gynekologie Mudr. Jaromir Karban S.R.ONeratovice, Czechia, 277 11 Privatni Gynekologicko-Porodnicka OrdinacePraha, Czechia, 16000 Gynevi S.R.O.Rokycany, Czechia, 337 01 Gynekologicka AmbulanceZabreh Na Morave, Czechia, 78901|Funabashi, Chiba, Japan, 273-8588 Tsujinaka Hospital KashiwanohaKashiwa, Chiba, Japan, 277-0871 Matsudo City General HospitalMatsudo, Chiba, Japan, 270-2296|Sapporo, Hokkaido, Japan, 004-0052 Ena Odori ClinicSapporo, Hokkaido, Japan, 060-0001 Tokeidai Memorial ClinicSapporo, Hokkaido, Japan, 060-0031 Yoshio ClinicSapporo, Hokkaido, Japan, 064-0808|Kako-Gun, Hyogo, Japan, 675-1115 Kobe City Medical Center General HospitalKobe, Hyogo, Japan, 650-0047|Takamatsu, Kagawa, Japan, 760-0017 Asahi ClinicTakamatsu, Kagawa, Japan, 760-0076 Kagawa Prefectural Central HospitalTakamatsu, Kagawa, Japan, 760-8557|Fujisawa, Kanagawa, Japan, 251-0041|Nakagyo-Ku, Kyoto, Japan, 604-8845|Fukuoka, Japan, 810-0001 Unoki ClinicKagoshima, Japan, 892-0826 Tetsu-Nakamura Obstetrics And Gynecology Internal MedicineKagoshima, Japan, 892-0845 Four Seasons Ladies' ClinicKumamoto, Japan, 860-0846 Japanese Red Cross Kumamoto HospitalKumamoto, Japan, 861-8520 Ijinkai Takeda General HospitalKyoto, Japan, 601-1495 Japanese Red Cross Kyoto Daini HospitalKyoto, Japan, 602-8026 Gokeikai Osaka Kaisei HospitalOsaka, Japan, 532-0003 Osaka City Hospital Organization Osaka City General HospitalOsaka, Japan, 534-0021 Medical Co. Leading Girls Women'S Clinic Luna ShinsaibashiOsaka, Japan, 542-0086|Soka, Saitama, Japan, 340-0028|Kusatsu, Shiga, Japan, 525-8585|Brasov, Romania, 500283 S.C. Sanador SrlBucharest, Romania, 011026 S.C. Genesys Fertility Center S.R.LBucuresti, Romania, 012071 S.C. Centrul Medical Euromed S.R.LBucuresti, Romania, 020762 Spitalul Clinic Nicolae MalaxaBucuresti, Romania, 022448 Spitalul Clinic Municipal Filantropia CraiovaCraiova, Romania, 200143 Russian Federation Altai State Medical UniversityBarnaul, Russian Federation, 656038 Maternity Hospital, 17Saint-Petersburg, Russian Federation, 192174 Close Joint Stock Company \"Medical Company Idk\"Samara, Russian Federation, 443067 Smolensk State Medical UniversitySmolensk, Russian Federation, 214019 Med Estetic CenterSt. Petersburg, Russian Federation, 192177 \"Granti-Med\"St. Petersburg, Russian Federation, 198329 Scien. Res. Institute Of Obsterics, Gyn. & ReproductionSt. Petersburg, Russian Federation, 199034|Chernivtsi, Ukraine, 58001 Vinnytsia City Clinical Maternity Hospital No 2Vinnytsia, Ukraine, 21001 Zaporizhzhia Regional Clinical HospitalZaporizhzhya, Ukraine, 69600|Birmingham, Alabama, United States, 35205|Canyon Country, California, United States, 91351 Diagnamics, Inc.Encinitas, California, United States, 92024 National Research InstituteHuntington Park, California, United States, 90255 Grossmont Center For Clinical ResearchLa Mesa, California, United States, 91942 West Coast Ob/Gyn AssociatesLa Mesa, California, United States, 91942 National Research InstitutePanorama City, California, United States, 91402 Artemis Institute For Clinical ResearchSan Diego, California, United States, 92103 Medical Center For Clinical ResearchSan Diego, California, United States, 92108|Clearwater, Florida, United States, 33759 Vital Pharma ResearchHialeah, Florida, United States, 33016 Solutions Through Advanced Research, Inc.Jacksonville, Florida, United States, 32256 Health Awareness, Inc.Jupiter, Florida, United States, 33458 South Florida Clinical Research InstituteMargate, Florida, United States, 33073 Savin Medical Group LlcMiami Lakes, Florida, United States, 33014 Suncoast Research Group, LlcMiami, Florida, United States, 33135 Advanced Pharma Cr, LlcMiami, Florida, United States, 33147 Genoma Research Group, Inc.Miami, Florida, United States, 33165 Florida Research Center, Inc.Miami, Florida, United States, 33174 Miami Dade Medical Research Institute, LlcMiami, Florida, United States, 33176 Vista Health ResearchMiami, Florida, United States, 33176 Palmetto Professional ResearchMiami, Florida, United States, 33186 A Premier Medical Research Of Florida, LlcOrange City, Florida, United States, 32763 Clinical Neurosciences Solutions, Inc. Dba Cns HealthcareOrlando, Florida, United States, 32801 Oviedo Medical Research, LlcOviedo, Florida, United States, 32765 Dmi ResearchPinellas Park, Florida, United States, 33782 Physician Care Clinical ResearchSarasota, Florida, United States, 34239|Snellville, Georgia, United States, 30078|Idaho Falls, Idaho, United States, 83404|Champaign, Illinois, United States, 61820|Fall River, Massachusetts, United States, 02720|Saginaw, Michigan, United States, 48602|Las Vegas, Nevada, United States, 89102|Greensboro, North Carolina, United States, 27408 Pmg Research Of WilmingtonWilmington, North Carolina, United States, 28401 Unified Women'S Clinical ResearchWinston-Salem, North Carolina, United States, 27103|Cincinnati, Ohio, United States, 45267|Portland, Oregon, United States, 97239-3011|Jenkintown, Pennsylvania, United States, 19046 University Of PennsylvaniaPhiladelphia, Pennsylvania, United States, 19104|Columbia, South Carolina, United States, 29201|Hixson, Tennessee, United States, 37343|Austin, Texas, United States, 78705 Gadolin ResearchBeaumont, Texas, United States, 77702 Discovery Clinical TrialsDallas, Texas, United States, 75231 Advances In Health, Inc.Houston, Texas, United States, 77030 Discovery Clinical TrialsSan Antonio, Texas, United States, 78258 Center Of Reproductive MedicineWebster, Texas, United States, 77598|Norfolk, Virginia, United States, 23502|Seattle, Washington, United States, 98105","Alabama|California|Florida|Georgia|Idaho|Illinois|Massachusetts|Michigan|Nevada|North Carolina|Ohio|Oregon|Pennsylvania|South Carolina|Tennessee|Texas|Virginia|Washington","Czechia|Japan|Romania|Ukraine|United States","Gynporcentrum S.R.O.|Chiba Funabashi Municipal Medical Center|Hokkaido Hashimoto Clinic|Hyogo Kosumo Clinic|Kagawa Takamatsu Red Cross Hospital|Kanagawa Shonan Fujisawa Tokushukai Hospital|Kyoto Kyoto City Hospital|Saiseikai Fukuoka General Hospital|Saitama Medical Topia Soka Hospital|Shiga Kusatsu General Hospital|S.C. Centrul Medical De Diagn Si Tratam Ambulator Neomed Srl|City Clinical Maternity Hospital No 1|Central Research Associates, Inc.|Clearview Medical Research, Llc|Women's Medical Research Group, Llc|Journey Medical Research|Women's Healthcare Associates, Pa|Women's Health Practice|New England Center For Clinical Research, Inc.|Great Lakes Research Group, Inc.|Altea Research Institute|Unified Women's Clinical Research|University Of Cincinnati|Oregon Health And Science University|The Clinical Trial Center, Llc|Vista Clinical Research|Chattanooga Women For Women|Women Partners In Health Obstetrics & Gynecology (Ob/Gyn)|Tidewater Physicians For Women|Seattle Women's: Health, Research, Gynecology",{"$nulls":3},"Bayer Study Director","2019-11-25","2020-05-25T16:37:13.619","2020-05-26T17:10:42.972","NCT03400956"]
["5ecbf439307e3d1b1f8d9d1f","NCT03400956","2020-01-23","Bayer","BAYN","Active, not recruiting","Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 4)","Bay-1002670|Vilaprisan","PR Modulator","Yes","['Bay-1002670', 'Vilaprisan']","No",null,"Phase 3",3,103,"Actual","2018-01-24","2020-12-31",{"$nulls":5},"The primary objective of this study is to show superiority of vilaprisan in the treatment of heavy menstrual bleeding (HMB) in subjects with uterine fibroids compared to placebo\n\nThe secondary objectives of this study are to additionally evaluate the efficacy and safety of vilaprisan in subjects with uterine fibroids",null,"A Randomized, Parallel-group, Double-blind and Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Vilaprisan in Subjects With Uterine Fibroids",15790,"Leiomyoma","Leiomyoma|Myoma","Oncology Solid Tumor","Oncology","Experimental","Vilaprisan|Placebo+Vilaprisan|Vilaprisan+Placebo","Vilaprisan: 2 treatment periods of 12 weeks, separated by 1 bleeding episode.|Placebo: 1 treatment period of 12 weeks; and Vilaprisan: 1 treatment period of 12 weeks; separated by 1 bleeding episode.|Vilaprisan: 1 treatment period of 12 weeks; and Placebo: 1 treatment period of 12 weeks; separated by 1 bleeding episode.","Drug","Vilaprisan (BAY1002670)|Placebo","Orally, coated tablet 2 mg, once daily|Orally, coated tablet, once daily",null,"Vilaprisan|Placebo+Vilaprisan|Vilaprisan+Placebo","\n\n * Women, 18 years or older in good general health\n * Diagnosis of uterine fibroid(s) documented by ultrasound at screening with at least 1 fibroid with largest diameter more than 30 mm and less than 120 mm\n * Heavy menstrual bleeding (HMB) in at least 2 bleeding periods during the screening period each with blood loss volume of >80.00 mL documented by the alkaline hematin (AH) method\n * An endometrial biopsy performed during the screening period without significant histological disorder such as endometrial hyperplasia (including simple hyperplasia) or other significant endometrial pathology\n * Use of an acceptable non-hormonal method of contraception (ie, either male condom, cap, diaphragm or sponge, each in combination with spermicide) starting at Visit 1 until the end of the study\n\n","\n\n * Pregnancy or lactation (less than 3 months since delivery, abortion, or lactation before start of treatment)\n * Hypersensitivity to any ingredient of the study drug\n * Hemoglobin values â‰¤6 g/dL or any condition requiring immediate blood transfusion (subjects with hemoglobin values â‰¤10.9 g/dL will be recommended to use iron supplementation)\n * Any diseases, conditions, or medications that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study drug\n * Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results\n * Abuse of alcohol, drugs or medicines (e.g. laxatives)\n * Use of other treatments that might interfere with the conduct of the study or the interpretation of results\n * Undiagnosed abnormal genital bleeding",{"$nulls":4},"Actual","2018-01-17","Actual","Anticipated","2020-12-31","Anticipated","2020-01-01","2018-01-05","2018-01-15","2020-01-22","No","Uterine fibroids\nHeavy menstrual bleeding","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"Female",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"2016-003561-26","EudraCT Number","Amenorrhea (yes/no)","Defined as menstrual blood loss (MBL) < 2 mL during the last 28 days of treatment","The last 28 days of treatment period 1","HMB response|Time to onset of amenorrhea|Time to onset of controlled bleeding|Absence of bleeding (spotting allowed)|Endometrial histology|Endometrial thickness","Defined as blood loss <80.00 mL during the last 28 days of treatment and >50% reduction compared to baseline|Onset of amenorrhea is defined by the first day for which the menstrual blood loss for all subsequent 28-day periods up to the end of the treatment period is <2 mL|Onset of controlled bleeding is defined by the first day for which the menstrual blood loss for all subsequent 28-day periods up to the end of the treatment period is <80.00 mL|Based on the UF-DBD (Uterine Fibroid Daily Bleeding Diary)|E.g. benign endometrium, presence or absence of hyperplasia or malignancy|Up to 36 weeks","The last 28 days of treatment period 1 and treatment period 2|In treatment period 1 (12 weeks) and in treatment period 2 (12 weeks)|Up to 36 weeks",{"$nulls":3},"Krnov, Czechia, 794 01 Gynekologie Mudr. Jaromir Karban S.R.ONeratovice, Czechia, 277 11 Privatni Gynekologicko-Porodnicka OrdinacePraha, Czechia, 16000 Gynevi S.R.O.Rokycany, Czechia, 337 01 Gynekologicka AmbulanceZabreh Na Morave, Czechia, 78901|Funabashi, Chiba, Japan, 273-8588 Tsujinaka Hospital KashiwanohaKashiwa, Chiba, Japan, 277-0871 Matsudo City General HospitalMatsudo, Chiba, Japan, 270-2296|Sapporo, Hokkaido, Japan, 004-0052 Ena Odori ClinicSapporo, Hokkaido, Japan, 060-0001 Tokeidai Memorial ClinicSapporo, Hokkaido, Japan, 060-0031 Yoshio ClinicSapporo, Hokkaido, Japan, 064-0808|Kako-Gun, Hyogo, Japan, 675-1115 Kobe City Medical Center General HospitalKobe, Hyogo, Japan, 650-0047|Takamatsu, Kagawa, Japan, 760-0017 Asahi ClinicTakamatsu, Kagawa, Japan, 760-0076 Kagawa Prefectural Central HospitalTakamatsu, Kagawa, Japan, 760-8557|Fujisawa, Kanagawa, Japan, 251-0041|Nakagyo-Ku, Kyoto, Japan, 604-8845|Fukuoka, Japan, 810-0001 Unoki ClinicKagoshima, Japan, 892-0826 Tetsu-Nakamura Obstetrics And Gynecology Internal MedicineKagoshima, Japan, 892-0845 Four Seasons Ladies' ClinicKumamoto, Japan, 860-0846 Japanese Red Cross Kumamoto HospitalKumamoto, Japan, 861-8520 Ijinkai Takeda General HospitalKyoto, Japan, 601-1495 Japanese Red Cross Kyoto Daini HospitalKyoto, Japan, 602-8026 Gokeikai Osaka Kaisei HospitalOsaka, Japan, 532-0003 Osaka City Hospital Organization Osaka City General HospitalOsaka, Japan, 534-0021 Medical Co. Leading Girls Women'S Clinic Luna ShinsaibashiOsaka, Japan, 542-0086 Russian Federation Altai State Medical UniversityBarnaul, Russian Federation, 656038 Maternity Hospital, 17Saint-Petersburg, Russian Federation, 192174 Close Joint Stock Company \"Medical Company Idk\"Samara, Russian Federation, 443067 Smolensk State Medical UniversitySmolensk, Russian Federation, 214019 Med Estetic CenterSt. Petersburg, Russian Federation, 192177 \"Granti-Med\"St. Petersburg, Russian Federation, 198329 Scien. Res. Institute Of Obsterics, Gyn. & ReproductionSt. Petersburg, Russian Federation, 199034|Soka, Saitama, Japan, 340-0028|Kusatsu, Shiga, Japan, 525-8585|Chernivtsi, Ukraine, 58001 Vinnytsia City Clinical Maternity Hospital No 2Vinnytsia, Ukraine, 21001 Zaporizhzhia Regional Clinical HospitalZaporizhzhya, Ukraine, 69600|Canyon Country, California, United States, 91351 Diagnamics, Inc.Encinitas, California, United States, 92024 National Research InstituteHuntington Park, California, United States, 90255 Grossmont Center For Clinical ResearchLa Mesa, California, United States, 91942 West Coast Ob/Gyn AssociatesLa Mesa, California, United States, 91942 National Research InstitutePanorama City, California, United States, 91402 Artemis Institute For Clinical ResearchSan Diego, California, United States, 92103 Medical Center For Clinical ResearchSan Diego, California, United States, 92108|Clearwater, Florida, United States, 33759 Vital Pharma ResearchHialeah, Florida, United States, 33016 Solutions Through Advanced Research, Inc.Jacksonville, Florida, United States, 32256 Health Awareness, Inc.Jupiter, Florida, United States, 33458 South Florida Clinical Research InstituteMargate, Florida, United States, 33073 Savin Medical Group LlcMiami Lakes, Florida, United States, 33014 Suncoast Research Group, LlcMiami, Florida, United States, 33135 Advanced Pharma Cr, LlcMiami, Florida, United States, 33147 Genoma Research Group, Inc.Miami, Florida, United States, 33165 Florida Research Center, Inc.Miami, Florida, United States, 33174 Miami Dade Medical Research Institute, LlcMiami, Florida, United States, 33176 Vista Health ResearchMiami, Florida, United States, 33176 Palmetto Professional ResearchMiami, Florida, United States, 33186 A Premier Medical Research Of Florida, LlcOrange City, Florida, United States, 32763 Clinical Neurosciences Solutions, Inc. Dba Cns HealthcareOrlando, Florida, United States, 32801 Oviedo Medical Research, LlcOviedo, Florida, United States, 32765 Dmi ResearchPinellas Park, Florida, United States, 33782 Physician Care Clinical ResearchSarasota, Florida, United States, 34239|Snellville, Georgia, United States, 30078|Idaho Falls, Idaho, United States, 83404|Fall River, Massachusetts, United States, 02720|Las Vegas, Nevada, United States, 89102|Greensboro, North Carolina, United States, 27408 Pmg Research Of WilmingtonWilmington, North Carolina, United States, 28401 Unified Women'S Clinical ResearchWinston-Salem, North Carolina, United States, 27103|Portland, Oregon, United States, 97239-3011|Jenkintown, Pennsylvania, United States, 19046 University Of PennsylvaniaPhiladelphia, Pennsylvania, United States, 19104|Columbia, South Carolina, United States, 29201|Hixson, Tennessee, United States, 37343|Austin, Texas, United States, 78705 Gadolin ResearchBeaumont, Texas, United States, 77702 Discovery Clinical TrialsDallas, Texas, United States, 75231 Advances In Health, Inc.Houston, Texas, United States, 77030 Discovery Clinical TrialsSan Antonio, Texas, United States, 78258 Center Of Reproductive MedicineWebster, Texas, United States, 77598|Norfolk, Virginia, United States, 23502|Seattle, Washington, United States, 98105","California|Florida|Georgia|Idaho|Massachusetts|Nevada|North Carolina|Oregon|Pennsylvania|South Carolina|Tennessee|Texas|Virginia|Washington","Czechia|Japan|Ukraine|United States","Gynporcentrum S.R.O.|Chiba Funabashi Municipal Medical Center|Hokkaido Hashimoto Clinic|Hyogo Kosumo Clinic|Kagawa Takamatsu Red Cross Hospital|Kanagawa Shonan Fujisawa Tokushukai Hospital|Kyoto Kyoto City Hospital|Saiseikai Fukuoka General Hospital|Saitama Medical Topia Soka Hospital|Shiga Kusatsu General Hospital|City Clinical Maternity Hospital No 1|Clearview Medical Research, Llc|Women's Medical Research Group, Llc|Journey Medical Research|Women's Healthcare Associates, Pa|New England Center For Clinical Research, Inc.|Altea Research Institute|Unified Women's Clinical Research|Oregon Health And Science University|The Clinical Trial Center, Llc|Vista Clinical Research|Chattanooga Women For Women|Women Partners In Health Obstetrics & Gynecology (Ob/Gyn)|Tidewater Physicians For Women|Seattle Women's: Health, Research, Gynecology",{"$nulls":3},"Bayer Study Director","2020-01-22","2020-05-25T16:37:13.783","2020-05-26T17:10:42.972","NCT03400956"]
["5ecbf439e2561b1b11905d8a","NCT03400956","2020-03-17","Bayer","BAYN","Active, not recruiting","Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 4)","Bay-1002670|Vilaprisan","PR Modulator","Yes","['Bay-1002670', 'Vilaprisan']","No",null,"Phase 3",3,103,"Actual","2018-01-24","2019-03-23",{"$nulls":5},"The primary objective of this study is to show superiority of vilaprisan in the treatment of heavy menstrual bleeding (HMB) in subjects with uterine fibroids compared to placebo\n\nThe secondary objectives of this study are to additionally evaluate the efficacy and safety of vilaprisan in subjects with uterine fibroids",null,"A Randomized, Parallel-group, Double-blind and Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Vilaprisan in Subjects With Uterine Fibroids",15790,"Leiomyoma","Leiomyoma|Myoma","Oncology Solid Tumor","Oncology","Experimental","Vilaprisan|Placebo+Vilaprisan|Vilaprisan+Placebo","Vilaprisan: 2 treatment periods of 12 weeks, separated by 1 bleeding episode.|Placebo: 1 treatment period of 12 weeks; and Vilaprisan: 1 treatment period of 12 weeks; separated by 1 bleeding episode.|Vilaprisan: 1 treatment period of 12 weeks; and Placebo: 1 treatment period of 12 weeks; separated by 1 bleeding episode.","Drug","Vilaprisan (BAY1002670)|Placebo","Orally, coated tablet 2 mg, once daily|Orally, coated tablet, once daily",null,"Vilaprisan|Placebo+Vilaprisan|Vilaprisan+Placebo","\n\n * Women, 18 years or older in good general health\n * Diagnosis of uterine fibroid(s) documented by ultrasound at screening with at least 1 fibroid with largest diameter more than 30 mm and less than 120 mm\n * Heavy menstrual bleeding (HMB) in at least 2 bleeding periods during the screening period each with blood loss volume of >80.00 mL documented by the alkaline hematin (AH) method\n * An endometrial biopsy performed during the screening period without significant histological disorder such as endometrial hyperplasia (including simple hyperplasia) or other significant endometrial pathology\n * Use of an acceptable non-hormonal method of contraception (ie, either male condom, cap, diaphragm or sponge, each in combination with spermicide) starting at Visit 1 until the end of the study\n\n","\n\n * Pregnancy or lactation (less than 3 months since delivery, abortion, or lactation before start of treatment)\n * Hypersensitivity to any ingredient of the study drug\n * Hemoglobin values â‰¤6 g/dL or any condition requiring immediate blood transfusion (subjects with hemoglobin values â‰¤10.9 g/dL will be recommended to use iron supplementation)\n * Any diseases, conditions, or medications that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study drug\n * Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results\n * Abuse of alcohol, drugs or medicines (e.g. laxatives)\n * Use of other treatments that might interfere with the conduct of the study or the interpretation of results\n * Undiagnosed abnormal genital bleeding",{"$nulls":4},"Actual","2018-01-17","Actual","Actual","2020-12-31","Anticipated","2020-03-01","2018-01-05","2018-01-15","2020-03-16","No","Uterine fibroids\nHeavy menstrual bleeding","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"Female",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"2016-003561-26","EudraCT Number","Amenorrhea (yes/no)","Defined as menstrual blood loss (MBL) < 2 mL during the last 28 days of treatment","The last 28 days of treatment period 1","HMB response|Time to onset of amenorrhea|Time to onset of controlled bleeding|Absence of bleeding (spotting allowed)|Endometrial histology|Endometrial thickness","Defined as blood loss <80.00 mL during the last 28 days of treatment and >50% reduction compared to baseline|Onset of amenorrhea is defined by the first day for which the menstrual blood loss for all subsequent 28-day periods up to the end of the treatment period is <2 mL|Onset of controlled bleeding is defined by the first day for which the menstrual blood loss for all subsequent 28-day periods up to the end of the treatment period is <80.00 mL|Based on the UF-DBD (Uterine Fibroid Daily Bleeding Diary)|E.g. benign endometrium, presence or absence of hyperplasia or malignancy|Up to 36 weeks","The last 28 days of treatment period 1 and treatment period 2|In treatment period 1 (12 weeks) and in treatment period 2 (12 weeks)|Up to 36 weeks",{"$nulls":3},"Krnov, Czechia, 794 01 Gynekologie Mudr. Jaromir Karban S.R.ONeratovice, Czechia, 277 11 Privatni Gynekologicko-Porodnicka OrdinacePraha, Czechia, 16000 Gynevi S.R.O.Rokycany, Czechia, 337 01 Gynekologicka AmbulanceZabreh Na Morave, Czechia, 78901|Funabashi, Chiba, Japan, 273-8588 Tsujinaka Hospital KashiwanohaKashiwa, Chiba, Japan, 277-0871 Matsudo City General HospitalMatsudo, Chiba, Japan, 270-2296|Sapporo, Hokkaido, Japan, 004-0052 Ena Odori ClinicSapporo, Hokkaido, Japan, 060-0001 Tokeidai Memorial ClinicSapporo, Hokkaido, Japan, 060-0031 Yoshio ClinicSapporo, Hokkaido, Japan, 064-0808|Kako-Gun, Hyogo, Japan, 675-1115 Kobe City Medical Center General HospitalKobe, Hyogo, Japan, 650-0047|Takamatsu, Kagawa, Japan, 760-0017 Asahi ClinicTakamatsu, Kagawa, Japan, 760-0076 Kagawa Prefectural Central HospitalTakamatsu, Kagawa, Japan, 760-8557|Fujisawa, Kanagawa, Japan, 251-0041|Nakagyo-Ku, Kyoto, Japan, 604-8845|Fukuoka, Japan, 810-0001 Unoki ClinicKagoshima, Japan, 892-0826 Tetsu-Nakamura Obstetrics And Gynecology Internal MedicineKagoshima, Japan, 892-0845 Four Seasons Ladies' ClinicKumamoto, Japan, 860-0846 Japanese Red Cross Kumamoto HospitalKumamoto, Japan, 861-8520 Ijinkai Takeda General HospitalKyoto, Japan, 601-1495 Japanese Red Cross Kyoto Daini HospitalKyoto, Japan, 602-8026 Gokeikai Osaka Kaisei HospitalOsaka, Japan, 532-0003 Osaka City Hospital Organization Osaka City General HospitalOsaka, Japan, 534-0021 Medical Co. Leading Girls Women'S Clinic Luna ShinsaibashiOsaka, Japan, 542-0086 Russian Federation Altai State Medical UniversityBarnaul, Russian Federation, 656038 Maternity Hospital, 17Saint-Petersburg, Russian Federation, 192174 Close Joint Stock Company \"Medical Company Idk\"Samara, Russian Federation, 443067 Smolensk State Medical UniversitySmolensk, Russian Federation, 214019 Med Estetic CenterSt. Petersburg, Russian Federation, 192177 \"Granti-Med\"St. Petersburg, Russian Federation, 198329 Scien. Res. Institute Of Obsterics, Gyn. & ReproductionSt. Petersburg, Russian Federation, 199034|Soka, Saitama, Japan, 340-0028|Kusatsu, Shiga, Japan, 525-8585|Chernivtsi, Ukraine, 58001 Vinnytsia City Clinical Maternity Hospital No 2Vinnytsia, Ukraine, 21001 Zaporizhzhia Regional Clinical HospitalZaporizhzhya, Ukraine, 69600|Canyon Country, California, United States, 91351 Diagnamics, Inc.Encinitas, California, United States, 92024 National Research InstituteHuntington Park, California, United States, 90255 Grossmont Center For Clinical ResearchLa Mesa, California, United States, 91942 West Coast Ob/Gyn AssociatesLa Mesa, California, United States, 91942 National Research InstitutePanorama City, California, United States, 91402 Artemis Institute For Clinical ResearchSan Diego, California, United States, 92103 Medical Center For Clinical ResearchSan Diego, California, United States, 92108|Clearwater, Florida, United States, 33759 Vital Pharma ResearchHialeah, Florida, United States, 33016 Solutions Through Advanced Research, Inc.Jacksonville, Florida, United States, 32256 Health Awareness, Inc.Jupiter, Florida, United States, 33458 South Florida Clinical Research InstituteMargate, Florida, United States, 33073 Savin Medical Group LlcMiami Lakes, Florida, United States, 33014 Suncoast Research Group, LlcMiami, Florida, United States, 33135 Advanced Pharma Cr, LlcMiami, Florida, United States, 33147 Genoma Research Group, Inc.Miami, Florida, United States, 33165 Florida Research Center, Inc.Miami, Florida, United States, 33174 Miami Dade Medical Research Institute, LlcMiami, Florida, United States, 33176 Vista Health ResearchMiami, Florida, United States, 33176 Palmetto Professional ResearchMiami, Florida, United States, 33186 A Premier Medical Research Of Florida, LlcOrange City, Florida, United States, 32763 Clinical Neurosciences Solutions, Inc. Dba Cns HealthcareOrlando, Florida, United States, 32801 Oviedo Medical Research, LlcOviedo, Florida, United States, 32765 Dmi ResearchPinellas Park, Florida, United States, 33782 Physician Care Clinical ResearchSarasota, Florida, United States, 34239|Snellville, Georgia, United States, 30078|Idaho Falls, Idaho, United States, 83404|Fall River, Massachusetts, United States, 02720|Las Vegas, Nevada, United States, 89102|Greensboro, North Carolina, United States, 27408 Pmg Research Of WilmingtonWilmington, North Carolina, United States, 28401 Unified Women'S Clinical ResearchWinston-Salem, North Carolina, United States, 27103|Portland, Oregon, United States, 97239-3011|Jenkintown, Pennsylvania, United States, 19046 University Of PennsylvaniaPhiladelphia, Pennsylvania, United States, 19104|Columbia, South Carolina, United States, 29201|Hixson, Tennessee, United States, 37343|Austin, Texas, United States, 78705 Gadolin ResearchBeaumont, Texas, United States, 77702 Discovery Clinical TrialsDallas, Texas, United States, 75231 Advances In Health, Inc.Houston, Texas, United States, 77030 Discovery Clinical TrialsSan Antonio, Texas, United States, 78258 Center Of Reproductive MedicineWebster, Texas, United States, 77598|Norfolk, Virginia, United States, 23502|Seattle, Washington, United States, 98105","California|Florida|Georgia|Idaho|Massachusetts|Nevada|North Carolina|Oregon|Pennsylvania|South Carolina|Tennessee|Texas|Virginia|Washington","Czechia|Japan|Ukraine|United States","Gynporcentrum S.R.O.|Chiba Funabashi Municipal Medical Center|Hokkaido Hashimoto Clinic|Hyogo Kosumo Clinic|Kagawa Takamatsu Red Cross Hospital|Kanagawa Shonan Fujisawa Tokushukai Hospital|Kyoto Kyoto City Hospital|Saiseikai Fukuoka General Hospital|Saitama Medical Topia Soka Hospital|Shiga Kusatsu General Hospital|City Clinical Maternity Hospital No 1|Clearview Medical Research, Llc|Women's Medical Research Group, Llc|Journey Medical Research|Women's Healthcare Associates, Pa|New England Center For Clinical Research, Inc.|Altea Research Institute|Unified Women's Clinical Research|Oregon Health And Science University|The Clinical Trial Center, Llc|Vista Clinical Research|Chattanooga Women For Women|Women Partners In Health Obstetrics & Gynecology (Ob/Gyn)|Tidewater Physicians For Women|Seattle Women's: Health, Research, Gynecology",{"$nulls":3},"Bayer Study Director","2020-03-16","2020-05-25T16:37:13.957","2020-05-26T17:10:42.972","NCT03400956"]
["5ecbf43afe30261b1a04828f","NCT03400956","2020-04-06","Bayer","BAYN","Active, not recruiting","Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 4)","Bay-1002670|Vilaprisan","PR Modulator","Yes","['Bay-1002670', 'Vilaprisan']","No",null,"Phase 3",3,103,"Actual","2018-01-24","2019-03-23",{"$nulls":5},"The primary objective of this study is to show superiority of vilaprisan in the treatment of heavy menstrual bleeding (HMB) in subjects with uterine fibroids compared to placebo\n\nThe secondary objectives of this study are to additionally evaluate the efficacy and safety of vilaprisan in subjects with uterine fibroids",null,"A Randomized, Parallel-group, Double-blind and Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Vilaprisan in Subjects With Uterine Fibroids",15790,"Leiomyoma","Leiomyoma|Myoma","Oncology Solid Tumor","Oncology","Experimental","Vilaprisan|Placebo+Vilaprisan|Vilaprisan+Placebo","Vilaprisan: 2 treatment periods of 12 weeks, separated by 1 bleeding episode.|Placebo: 1 treatment period of 12 weeks; and Vilaprisan: 1 treatment period of 12 weeks; separated by 1 bleeding episode.|Vilaprisan: 1 treatment period of 12 weeks; and Placebo: 1 treatment period of 12 weeks; separated by 1 bleeding episode.","Drug","Vilaprisan (BAY1002670)|Placebo","Orally, coated tablet 2 mg, once daily|Orally, coated tablet, once daily",null,"Vilaprisan|Placebo+Vilaprisan|Vilaprisan+Placebo","\n\n * Women, 18 years or older in good general health\n * Diagnosis of uterine fibroid(s) documented by ultrasound at screening with at least 1 fibroid with largest diameter more than 30 mm and less than 120 mm\n * Heavy menstrual bleeding (HMB) in at least 2 bleeding periods during the screening period each with blood loss volume of >80.00 mL documented by the alkaline hematin (AH) method\n * An endometrial biopsy performed during the screening period without significant histological disorder such as endometrial hyperplasia (including simple hyperplasia) or other significant endometrial pathology\n * Use of an acceptable non-hormonal method of contraception (ie, either male condom, cap, diaphragm or sponge, each in combination with spermicide) starting at Visit 1 until the end of the study\n\n","\n\n * Pregnancy or lactation (less than 3 months since delivery, abortion, or lactation before start of treatment)\n * Hypersensitivity to any ingredient of the study drug\n * Hemoglobin values â‰¤6 g/dL or any condition requiring immediate blood transfusion (subjects with hemoglobin values â‰¤10.9 g/dL will be recommended to use iron supplementation)\n * Any diseases, conditions, or medications that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study drug\n * Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results\n * Abuse of alcohol, drugs or medicines (e.g. laxatives)\n * Use of other treatments that might interfere with the conduct of the study or the interpretation of results\n * Undiagnosed abnormal genital bleeding",{"$nulls":4},"Actual","2018-01-17","Actual","Actual","2020-12-31","Anticipated","2020-03-01","2018-01-05","2018-01-15","2020-03-31","No","Uterine fibroids\nHeavy menstrual bleeding","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"Female",null,"No",{"$nulls":4},"Yes","No",{"$nulls":7},43907,43921,"April 6, 2020 [Actual]",{"$nulls":7},"2016-003561-26","EudraCT Number","Amenorrhea (yes/no)","Defined as menstrual blood loss (MBL) < 2 mL during the last 28 days of treatment","The last 28 days of treatment period 1","HMB response|Time to onset of amenorrhea|Time to onset of controlled bleeding|Absence of bleeding (spotting allowed)|Endometrial histology|Endometrial thickness","Defined as blood loss <80.00 mL during the last 28 days of treatment and >50% reduction compared to baseline|Onset of amenorrhea is defined by the first day for which the menstrual blood loss for all subsequent 28-day periods up to the end of the treatment period is <2 mL|Onset of controlled bleeding is defined by the first day for which the menstrual blood loss for all subsequent 28-day periods up to the end of the treatment period is <80.00 mL|Based on the UF-DBD (Uterine Fibroid Daily Bleeding Diary)|E.g. benign endometrium, presence or absence of hyperplasia or malignancy|Up to 36 weeks","The last 28 days of treatment period 1 and treatment period 2|In treatment period 1 (12 weeks) and in treatment period 2 (12 weeks)|Up to 36 weeks",{"$nulls":3},"Krnov, Czechia, 794 01 Gynekologie Mudr. Jaromir Karban S.R.ONeratovice, Czechia, 277 11 Privatni Gynekologicko-Porodnicka OrdinacePraha, Czechia, 16000 Gynevi S.R.O.Rokycany, Czechia, 337 01 Gynekologicka AmbulanceZabreh Na Morave, Czechia, 78901|Funabashi, Chiba, Japan, 273-8588 Tsujinaka Hospital KashiwanohaKashiwa, Chiba, Japan, 277-0871 Matsudo City General HospitalMatsudo, Chiba, Japan, 270-2296|Sapporo, Hokkaido, Japan, 004-0052 Ena Odori ClinicSapporo, Hokkaido, Japan, 060-0001 Tokeidai Memorial ClinicSapporo, Hokkaido, Japan, 060-0031 Yoshio ClinicSapporo, Hokkaido, Japan, 064-0808|Kako-Gun, Hyogo, Japan, 675-1115 Kobe City Medical Center General HospitalKobe, Hyogo, Japan, 650-0047|Takamatsu, Kagawa, Japan, 760-0017 Asahi ClinicTakamatsu, Kagawa, Japan, 760-0076 Kagawa Prefectural Central HospitalTakamatsu, Kagawa, Japan, 760-8557|Fujisawa, Kanagawa, Japan, 251-0041|Nakagyo-Ku, Kyoto, Japan, 604-8845|Fukuoka, Japan, 810-0001 Unoki ClinicKagoshima, Japan, 892-0826 Tetsu-Nakamura Obstetrics And Gynecology Internal MedicineKagoshima, Japan, 892-0845 Four Seasons Ladies' ClinicKumamoto, Japan, 860-0846 Japanese Red Cross Kumamoto HospitalKumamoto, Japan, 861-8520 Ijinkai Takeda General HospitalKyoto, Japan, 601-1495 Japanese Red Cross Kyoto Daini HospitalKyoto, Japan, 602-8026 Gokeikai Osaka Kaisei HospitalOsaka, Japan, 532-0003 Osaka City Hospital Organization Osaka City General HospitalOsaka, Japan, 534-0021 Medical Co. Leading Girls Women'S Clinic Luna ShinsaibashiOsaka, Japan, 542-0086 Russian Federation Altai State Medical UniversityBarnaul, Russian Federation, 656038 Maternity Hospital, 17Saint-Petersburg, Russian Federation, 192174 Close Joint Stock Company \"Medical Company Idk\"Samara, Russian Federation, 443067 Smolensk State Medical UniversitySmolensk, Russian Federation, 214019 Med Estetic CenterSt. Petersburg, Russian Federation, 192177 \"Granti-Med\"St. Petersburg, Russian Federation, 198329 Scien. Res. Institute Of Obsterics, Gyn. & ReproductionSt. Petersburg, Russian Federation, 199034|Soka, Saitama, Japan, 340-0028|Kusatsu, Shiga, Japan, 525-8585|Chernivtsi, Ukraine, 58001 Vinnytsia City Clinical Maternity Hospital No 2Vinnytsia, Ukraine, 21001 Zaporizhzhia Regional Clinical HospitalZaporizhzhya, Ukraine, 69600|Canyon Country, California, United States, 91351 Diagnamics, Inc.Encinitas, California, United States, 92024 National Research InstituteHuntington Park, California, United States, 90255 Grossmont Center For Clinical ResearchLa Mesa, California, United States, 91942 West Coast Ob/Gyn AssociatesLa Mesa, California, United States, 91942 National Research InstitutePanorama City, California, United States, 91402 Artemis Institute For Clinical ResearchSan Diego, California, United States, 92103 Medical Center For Clinical ResearchSan Diego, California, United States, 92108|Clearwater, Florida, United States, 33759 Vital Pharma ResearchHialeah, Florida, United States, 33016 Solutions Through Advanced Research, Inc.Jacksonville, Florida, United States, 32256 Health Awareness, Inc.Jupiter, Florida, United States, 33458 South Florida Clinical Research InstituteMargate, Florida, United States, 33073 Savin Medical Group LlcMiami Lakes, Florida, United States, 33014 Suncoast Research Group, LlcMiami, Florida, United States, 33135 Advanced Pharma Cr, LlcMiami, Florida, United States, 33147 Genoma Research Group, Inc.Miami, Florida, United States, 33165 Florida Research Center, Inc.Miami, Florida, United States, 33174 Miami Dade Medical Research Institute, LlcMiami, Florida, United States, 33176 Vista Health ResearchMiami, Florida, United States, 33176 Palmetto Professional ResearchMiami, Florida, United States, 33186 A Premier Medical Research Of Florida, LlcOrange City, Florida, United States, 32763 Clinical Neurosciences Solutions, Inc. Dba Cns HealthcareOrlando, Florida, United States, 32801 Oviedo Medical Research, LlcOviedo, Florida, United States, 32765 Dmi ResearchPinellas Park, Florida, United States, 33782 Physician Care Clinical ResearchSarasota, Florida, United States, 34239|Snellville, Georgia, United States, 30078|Idaho Falls, Idaho, United States, 83404|Fall River, Massachusetts, United States, 02720|Las Vegas, Nevada, United States, 89102|Greensboro, North Carolina, United States, 27408 Pmg Research Of WilmingtonWilmington, North Carolina, United States, 28401 Unified Women'S Clinical ResearchWinston-Salem, North Carolina, United States, 27103|Portland, Oregon, United States, 97239-3011|Jenkintown, Pennsylvania, United States, 19046 University Of PennsylvaniaPhiladelphia, Pennsylvania, United States, 19104|Columbia, South Carolina, United States, 29201|Hixson, Tennessee, United States, 37343|Austin, Texas, United States, 78705 Gadolin ResearchBeaumont, Texas, United States, 77702 Discovery Clinical TrialsDallas, Texas, United States, 75231 Advances In Health, Inc.Houston, Texas, United States, 77030 Discovery Clinical TrialsSan Antonio, Texas, United States, 78258 Center Of Reproductive MedicineWebster, Texas, United States, 77598|Norfolk, Virginia, United States, 23502|Seattle, Washington, United States, 98105","California|Florida|Georgia|Idaho|Massachusetts|Nevada|North Carolina|Oregon|Pennsylvania|South Carolina|Tennessee|Texas|Virginia|Washington","Czechia|Japan|Ukraine|United States","Gynporcentrum S.R.O.|Chiba Funabashi Municipal Medical Center|Hokkaido Hashimoto Clinic|Hyogo Kosumo Clinic|Kagawa Takamatsu Red Cross Hospital|Kanagawa Shonan Fujisawa Tokushukai Hospital|Kyoto Kyoto City Hospital|Saiseikai Fukuoka General Hospital|Saitama Medical Topia Soka Hospital|Shiga Kusatsu General Hospital|City Clinical Maternity Hospital No 1|Clearview Medical Research, Llc|Women's Medical Research Group, Llc|Journey Medical Research|Women's Healthcare Associates, Pa|New England Center For Clinical Research, Inc.|Altea Research Institute|Unified Women's Clinical Research|Oregon Health And Science University|The Clinical Trial Center, Llc|Vista Clinical Research|Chattanooga Women For Women|Women Partners In Health Obstetrics & Gynecology (Ob/Gyn)|Tidewater Physicians For Women|Seattle Women's: Health, Research, Gynecology",{"$nulls":3},"Bayer Study Director","2020-03-31","2020-05-25T16:37:14.353","2020-05-26T17:10:42.972","NCT03400956"]
["5ecbf43ae2561b1b11905d8c","NCT03401112","2018-01-17","Imara","IMRA","Recruiting","A Study of IMR-687 in Adult Patients With Sickle Cell Anaemia (Homozygous HbSS or Sickle-Î²0 Thalassemia)","Imr-687",null,"Yes","['Imr-687']","Unknown",null,"Phase 2",3,54,"Anticipated","2018-01-01","2019-06-01",{"$nulls":5},"A Phase 2a randomized, placebo-controlled, multicenter study of orally administered IMR-687 in adults with Sickle Cell Anaemia (SCA).","This is a proof of concept study in adult SCA patients, age 18-50 years old. The primary goal is to examine the safety, pharmacokinetics and preliminary pharmacodynamics of escalating doses of IMR-687 as compared to placebo.","A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study of IMR-687 in Adult Patients With Sickle Cell Anaemia (Homozygous HbSS or Sickle-Î²0 Thalassemia)","IMR-SCD-102","Sickle Cell Disease","beta-Thalassemia|Thalassemia","Hematologic Diseases","Heme & Lymph Diseases","Placebo Comparator|Experimental","PBO|Dose 1|Dose 2","IMR-687","Drug","IMR-687","Oral administration of once daily IMR-687",null,"PBO|Dose 1|Dose 2","\n\n * Male or female patients with confirmed SCD\n * Age 18-50 years, inclusive\n * For patients on hydroxyurea, must have been on a stable dose for at least 60 days prior to screening\n\n","\n\n * Total hemoglobin >11 or less than 6 g/dL\n * RBC transfusion within 60 days of baseline\n * >3 hospitalizations for vasoocclusive crises within the last year\n * eGFR < 50 ml/min\n * AST/ALT > 3x the upper limit of normal","SCD","stearoyl-CoA desaturase","Gene","Prostate","Actual","2018-01-17","Actual","Anticipated","2019-06-01","Anticipated","2018-01-01","2018-01-02","2018-01-09","2018-01-09","Yes",null,"Interventional","Treatment","Parallel Assignment","Triple (Participant, Care Provider, Investigator)","Randomized","18 Years","50 Years","All",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":19},"Incidence of treatment-emergent adverse events (safety and tolerability).","Proportion of patients with adverse events","Baseline to Week 24","Maximum plasma concentration of IMR-687 (Cmax)|Area under the Curve (AUC) of IMR-687|Maximum plasma concentration of hydroxyurea|Area under the curve (AUC) of hydroxyurea","1, 4 and 12 weeks|Baseline and 4 weeks",null,"syfoo@imaratx.com","ShiYin Foo, MD PhD","617-231-6020","Birmingham, United Kingdom",null,"United Kingdom","Birmingham And Sandwell",{"$nulls":4},"2018-01-09","2020-05-25T16:37:14.971","2020-05-26T17:10:42.972","NCT03401112"]
["5ecbf43a11702c1b1b916aa1","NCT03401112","2018-06-01","Imara","IMRA","Recruiting","A Study of IMR-687 in Adult Patients With Sickle Cell Anaemia (Homozygous HbSS or Sickle-Î²0 Thalassemia)","Imr-687",null,"Yes","['Imr-687']","Unknown",null,"Phase 2",3,54,"Anticipated","2018-01-26","2019-06-01",{"$nulls":5},"A Phase 2a randomized, placebo-controlled, multicenter study of orally administered IMR-687 in adults with Sickle Cell Anaemia (SCA).","This is a proof of concept study in adult SCA patients, age 18-50 years old. The primary goal is to examine the safety, pharmacokinetics and preliminary pharmacodynamics of escalating doses of IMR-687 as compared to placebo.","A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study of IMR-687 in Adult Patients With Sickle Cell Anaemia (Homozygous HbSS or Sickle-Î²0 Thalassemia)","IMR-SCD-102","Sickle Cell Disease","beta-Thalassemia|Thalassemia","Hematologic Diseases","Heme & Lymph Diseases","Placebo Comparator|Experimental","PBO|Dose 1|Dose 2","IMR-687","Drug","IMR-687","Oral administration of once daily IMR-687",null,"PBO|Dose 1|Dose 2","\n\n * Male or female patients with confirmed SCD\n * Age 18-50 years, inclusive\n * For patients on hydroxyurea, must have been on a stable dose for at least 60 days prior to screening\n\n","\n\n * Total hemoglobin >11 or less than 6 g/dL\n * RBC transfusion within 60 days of baseline\n * >3 hospitalizations for vasoocclusive crises within the last year\n * eGFR < 50 ml/min\n * AST/ALT > 3x the upper limit of normal","SCD","stearoyl-CoA desaturase","Gene","Prostate","Actual","2018-01-17","Actual","Anticipated","2019-06-01","Anticipated","2018-05-01","2018-01-02","2018-01-09","2018-05-31","Yes",null,"Interventional","Treatment","Parallel Assignment","Triple (Participant, Care Provider, Investigator)","Randomized","18 Years","50 Years","All",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":19},"Incidence of treatment-emergent adverse events (safety and tolerability).","Proportion of patients with adverse events","Baseline to Week 24","Maximum plasma concentration of IMR-687 (Cmax)|Area under the Curve (AUC) of IMR-687|Maximum plasma concentration of hydroxyurea|Area under the curve (AUC) of hydroxyurea","1, 4 and 12 weeks|Baseline and 4 weeks",null,"JDatt@imaratx.com","Joe Datt, MD, MRCPCH",{"$f":"447900-801804","v":-353904},"Birmingham, United Kingdom|Farmington, Connecticut, United States, 06030|Charleston, South Carolina, United States, 29425","Connecticut|South Carolina","United Kingdom|United States","Birmingham And Sandwell|University Of Connecticut Health Center (Uconn Health)|Medical University Of South Carolina",{"$nulls":4},"2018-05-31","2020-05-25T16:37:14.974","2020-05-26T17:10:42.972","NCT03401112"]
["5ecbf43be2561b1b11905d8d","NCT03401112","2019-08-12","Imara","IMRA","Recruiting","A Study of IMR-687 in Adult Patients With Sickle Cell Anaemia (Homozygous HbSS or Sickle-Î²0 Thalassemia)","Imr-687",null,"Yes","['Imr-687']","Unknown",null,"Phase 2",3,70,"Anticipated","2018-01-26","2020-07-01",{"$nulls":5},"A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study of IMR-687 in Adult Patients with Sickle Cell Anaemia (Homozygous HbSS or Sickle-Î²0 Thalassemia).","This is a proof-of-concept study in adult SCA patients, ages 18 to 55 years old, to examine the safety, tolerability, and PK, as well as the potential PD effects and clinical efficacy, of IMR-687 across a range of doses.","A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study of IMR-687 in Adult Patients With Sickle Cell Anaemia (Homozygous HbSS or Sickle-Î²0 Thalassemia)","IMR-SCD-102","Sickle Cell Disease","beta-Thalassemia|Thalassemia","Hematologic Diseases","Heme & Lymph Diseases","Placebo Comparator|Experimental","Placebo|Dose 1|Dose 2","IMR-687","Drug","IMR-687","Oral administration of once daily IMR-687",null,"Placebo|Dose 1|Dose 2","\n\n * Male or female patients with confirmed SCA\n * Age 18-55 years, inclusive\n * For patients on hydroxyurea, must have been on a stable dose for at least 60 days prior to screening\n\n","\n\n * Total hemoglobin >12.5 or less than 6 g/dL\n * RBC transfusion within 60 days of baseline\n * >7 hospitalizations for vasoocclusive crises within the last year\n * eGFR < 50 ml/min\n * AST/ALT > 3x the upper limit of normal",{"$nulls":4},"Actual","2018-01-17","Actual","Anticipated","2020-09-01","Anticipated","2019-08-01","2018-01-02","2018-01-09","2019-08-08","Yes",null,"Interventional","Treatment","Parallel Assignment","Triple (Participant, Care Provider, Investigator)","Randomized","18 Years","55 Years","All",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":19},"Proportion of patients with adverse events and serious adverse events|Proportion of patients with changes in safety cardiac parameters|Proportion of patients with changes in clinical laboratory tests|Proportion of patients with clinically significant abnormal vital signs","1. Incidence of Adverse Events\n 2. Incidence of Serious Adverse Events|1. Changes in 12-lead ECG parameters that are clinically significant and measured in milliseconds (ms).The parameters are: PR interval, QRS duration, QT interval, ST segment duration and T wave duration.\n    \n    \n 2. Changes in 12-lead ECG parameters that are clinically significant and interpreted by the investigator as consistent with ischemia or infarction.|a. Clinically significant changes in clinical laboratory tests including serum chemistry, serum hematology and urinalysis|1. Blood pressure measured in mmHg\n 2. Pulse measured in beats per minute\n 3. Respiration rate measured in breaths per minutes\n 4. Temperature as measured in degrees F0 or C0","Baseline to Week 24","Maximum plasma concentration of IMR-687 (Cmax)|Area under the Curve (AUC) of IMR-687|Maximum plasma concentration of hydroxyurea|Area under the curve (AUC) of hydroxyurea","1, 4 and 12 weeks|Baseline and 4 weeks",null,"ELisbon@imaratx.com","Eleanor Lisbon, MD, MPH","+1 913-449-4319","Birmingham, United Kingdom|Oakland, California, United States, 94609|Farmington, Connecticut, United States, 06030|Hollywood, Florida, United States, 33021|[Active, Not Recruiting]Atlanta, Georgia, United States, 30312|Chicago, Illinois, United States, 60612|Greenville, North Carolina, United States, 27834|[Active, Not Recruiting]Charleston, South Carolina, United States, 29425","California|Connecticut|Florida|Georgia|Illinois|North Carolina|South Carolina","United Kingdom|United States","Birmingham And Sandwell|Ucsf Benioff Children's Hospital Oakland|University Of Connecticut Health Center (Uconn Health)|Foundation For Sickle Cell Disease Research|Primary Care Research Center|University Of Illinois|East Carolina University|Medical University Of South Carolina",{"$nulls":4},"2019-08-08","2020-05-25T16:37:15.117","2020-05-26T17:10:42.972","NCT03401112"]
["5ecbf43c307e3d1b1f8d9d25","NCT03401229","2018-01-23","AstraZeneca","AZN","Recruiting","Efficacy and Safety Study of Benralizumab for Patients With Severe Nasal Polyposis (OSTRO)","Benralizumab|Mometasone","IL5 Inhibitor|GR Agonist","No",null,"No",null,"Phase 3",2,400,"Anticipated","2018-01-15","2020-02-05",{"$nulls":5},"The aim of this present study is to investigate the use of benralizumab as treatment for severe nasal polyposis. The effect of benralizumab on nasal polyps will be assessed over a 56 weeks of treatment period in patients with severe bilateral nasal polyposis who are still symptomatic despite standard of care therapy, i.e current use of intranasal corticosteroids (INCS) and prior surgery and/or use of systemic corticosteroids. The first 200 patients that complete the 56-week treatment will have a 6 month follow-up (FU) period without dosing.",null,"A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Phase 3 Efficacy and Safety Study Of Benralizumab in Patients With Severe Nasal Polyposis","D3252C00001","Nasal Polyposis","Nasal Polyposis","Nose Diseases","Respiratory","Experimental|Placebo Comparator","Benralizumab 30mg SC + MF|Placebo SC + MF","SC - subcutaneously MF - Mometasone Furoate","Biological","Benralizumab 30 mg SC + Mometasone Furoate|Matching placebo SC + Mometasone Furoate",null,null,"Benralizumab 30mg SC + MF|Placebo SC + MF","\n\n 1.  Capable of giving signed informed consent, which includes compliance with the requirements and restrictions, listed in the informed consent form (ICF) and in protocol.\n 2.  Provision of signed and dated, written informed consent form (ICF) prior to any mandatory study specific procedures, sampling, and analyses and according to international guidelines and/or applicable European Union (EU) guidelines.\n 3.  Provision of signed and dated written genetic informed consent in patients that agree to participate in the genetic sampling, prior to collection of sample for genetic analysis.\n 4.  Female or male patients aged 18 to 75 years inclusive, at the time of signing the ICF.\n 5.  Patients with bilateral sinonasal polyposis that, despite treatment with intranasal corticosteroids (INCS) and a history of treatment with systemic (SCS -oral, parenteral) or prior surgery for nasal polyposis (NP), have severity consistent with a need for surgery as described by: * A minimum bilateral Nasal Polyp Score (NPS) of 5 out of a maximum score of 8 (with a unilateral score of at least 2 for each nostril;\n      * Ongoing symptoms for at least 12 weeks prior to V1;\n      * Patient-reported moderate to severe nasal blockage score (NBS) 2 or 3 over the 2-weeks prior to V1 (2-week recall assessment of symptoms, scores 0-none to 3-severe).\n     \n     \n 6.  SNOT-22 total score > 30 at enrolment.Patient must meet the following criteria (points 7-10) at the randomization visit:\n     \n     \n 7.  At least 8 days of evaluable daily diary data in the 14-day period prior to randomization (baseline bi-weekly mean score collected from study Day -13 to study Day 0).\n 8.  At randomization, a bi-weekly mean NBS â‰¥ 1.5.\n 9.  SNOT-22 total score > 30 at randomization.\n 10. At least 70% compliance with INCS during the run-in period based on daily diary.\n 11. Patients with a minimum weight of 40kg.\n 12. Negative serum pregnancy test result and a negative urine pregnancy test at randomization for female patients of childbearing potential.\n 13. Women of childbearing potential (WOCBP) must use an effective form of birth control as defined in the Clinical Study Protocol (CSP).\n\n15. All male patients who are sexually active must agree to use an acceptable method of contraception(condom with or without spermicide)\n\n","\n\n 1.  Patients who have undergone any nasal and/or sinus surgery within 6 months before screening.\n 2.  Patients with conditions or concomitant disease that makes them non evaluable for the co-primary efficacy endpoint such as: * Unilateral antrochoanal polyps;\n      * Nasal septal deviation that occludes at least one nostril;\n      * Acute sinusitis, nasal infection, or upper respiratory infection at screening or in the 2 weeks before screening;\n      * Current rhinitis medicamentosa;\n      * Allergic fungal rhinosinusitis;\n      * Nasal cavity tumors.\n     \n     \n 3.  Clinically important comorbidities that could confound interpretation of clinical efficacy results including, but not limited to: active upper or lower respiratory tract infection, cystic fibrosis, primary ciliary dyskinesia, eosinophilic diseases other than asthma (e.g. allergic bronchopulmonary aspergillosis/mycosis, eosinophilic granulomatosis with polyangitis [Churg-Strauss syndrome], hypereosinophilic syndromes), granulomatosis with polyangitis (Wegener's granulomatosis), Young's syndrome, etc.\n 4.  Any disorder, including but not limited to: cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric, or major physical impairment that is not stable in the opinion of the Investigator or AstraZeneca and could: * Affect the safety of the patient throughout the study;\n      * Influence the findings of the studies or their interpretations;\n      * Impede the patient's ability to complete the entire duration of study.\n     \n     \n 5.  Patients experiencing an asthma exacerbation requiring systemic (oral and/or parenteral) corticosteroids treatment or hospitalization (>24hrs) for treatment of asthma within 3 months prior to screening or during screening.\n 6.  History of anaphylaxis to any biologic therapy or vaccine.\n 7.  Known history of allergy or reaction to any component of the Investigational Product (IP) formulation.\n 8.  History of Guillain-BarrÃ© syndrome.\n 9.  A helminth parasitic infection diagnosed within 24 weeks prior to the date informed consent is obtained that has not been treated with, or has failed to respond to standard of care therapy.\n 10. Current malignancy, or history of malignancy, except for: - Patients who have had basal cell carcinoma, localized squamous cell carcinoma of the skin, or in situ carcinoma of the cervix are eligible provided that patient is in remission and curative therapy was completed at least 12 months prior to the date informed consent, and assent, when applicable was obtained; - Patients who have had other malignancies are eligible provided that the patient is in remission and curative therapy was completed at least 5 years prior to the date of informed consent, and assent, when applicable, was obtained.\n 11. Any clinically significant cardiac disease or any electrocardiogram (ECG) abnormality obtained during the screening/run-in period, which may put the patient at risk or interfere with study assessments.\n 12. Positive hepatitis B surface antigen, or hepatitis C virus antibody serology (confirmed by additional testing, eg, hepatitis C RNA test, if indicated), or a positive medical history for hepatitis B or C. Patients with history of hepatitis B vaccination without history of hepatitis B are allowed to enrol.\n 13. History of known immunodeficiency disorder, including a positive human immunodeficiency virus (HIV) test.\n 14. Infection requiring systemic antibiotics within 14 days prior to the date informed consent is obtained or during the screening/run-in period.\n 15. Use of immunosuppressive medication (including but not limited to: methotrexate, troleandomycin, cyclosporine, azathioprine, systemic corticosteroid for condition other than short course for nasal polyps, or any experimental anti-inflammatory therapy) within 3 months prior to the date informed consent is obtained.\n 16. Receipt of any marketed or investigational biologic (monoclonal or polyclonal antibody) within 4 months or 5 half-lives prior to the date informed consent, is obtained, whichever is longer.\n 17. Previous receipt of mepolizumab, reslizumab, dupilumab, or benralizumab.\n 18. Receipt of immunoglobulin or blood products within 30 days prior to the date informed consent is obtained.\n 19. Receipt of live attenuated vaccines 30 days prior to the date of randomization.\n 20. Receipt of any investigational drug within 30 days or 5 half-lives prior to randomization, whichever is longer.\n 21. Receipt of burst of systemic corticosteroid within 2 months before screening, during screening or are scheduled to receive systemic corticosteroid during the study period.\n 22. Receipt of leukotriene antagonist/modifiers for patients who were not on continuous treatment for â‰¥30 days prior visit 1.\n 23. Concurrent enrolment in another clinical drug interventional trial.\n 24. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level > 3 times the upper limit of normal (ULN) confirmed during screening period.\n 25. Previous randomization in the present study.\n 26. Planned surgical procedures at the time of the study enrolment and randomization, including a scheduled NP surgery.\n 27. Initiated or is being maintained on an aspirin desensitization regimen for the management of aspirin exacerbated respiratory disease (AERD) at the time of study enrolment or during the run-in period.\n 28. For women only - currently pregnant (or intend to become pregnant), breastfeeding or lactating.",{"$nulls":4},"Actual","2018-01-17","Actual","Anticipated","2020-02-05","Anticipated","2018-01-01","2017-12-13","2018-01-09","2018-01-22","No","Polyps\nNasal polyps\nNasal polyposis\nNose diseases\nRespiratory tract diseases\nOtorhinolaryngologic diseases\nBenralizumab\nMometasone furoate","Interventional","Treatment","Parallel Assignment","Triple (Participant, Care Provider, Investigator)","Randomized","18 Years","75 Years","All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"2017-003675-61","EudraCT Number","Effect of benralizumab on nasal polyp burden|Effect of benralizumab on patient reported nasal blockage (NB)","Change from baseline in endoscopic total nasal polyp score (NPS). NPS (maximum 8) is the sum of the right and left nostril scores|Change from baseline in mean nasal blockage score (NBS). NBS is assessed in daily diary by asking patients to rate the severity of their worst nasal blockage over the past 24 hours using the following response options: 0 - None; 1 - Mild; 2 - Moderate; 3 - Severe","Week 56 (visit 11)","Effect of benralizumab on disease specific health-related quality of life (HRQoL)|Effect of benralizumab on nasal polyp (NP) surgery|Proportion of NP Surgery|Systemic corticosteroids (SCS) use for relief of nasal symptoms|Symptoms associated with nasal polyps|Sinus opacification by computed tomography (CT) scan (subset of patients)|Patient-reported general health status|Other Pre-specified Outcome Measures:|Assessment of the safety of benralizumab|Assessment of the immunogenicity of benralizumab","Change from baseline in SinoNasal Outcome Test (SNOT-22) score. SNOT-22 captures patient-reported physical problems, functional limitations, and emotional consequences of sinonasal condition. It`s patient-reported symptom severity and symptom impact over the past 2 weeks and are captured via a 6-point scale (0- No Problem to 5- Problem as bad as it can be). The total score is the sum of item scores and has a range from 0 to 110|Time to first NP surgery|Proportion of patients with surgery for NP|Proportion of patients with SCS use for NP|Time to first SCS course for NP|Change from baseline in nasal symptom score(s) as captured in the daily diary. Patients report the severity of symptom related to NP at its worst using a 4-point verbal rating scale (0-None to 3-Severe).|Sense of smell captured as change from baseline in University of Pennsylvania Smell Identification Test (UPSIT) score.\n\nIt is a quantitative test of olfactory function which uses microencapsulated odorants that are released by scratching standardized odor-impregnated test booklets. Four booklets each with 10 odorants each are used for the test. Patients are asked to identify the odor using multiple choice format which lists different possibilities. Scores are based on number of correctly identified odors (score range 0 to 40).|Change from baseline in Lund Mackay score|Change from baseline in Short Form 36-item Health survey, Version 2 (SF-36v2)|Total SCS dose used|Number of courses of SCS for NP|Total duration of SCS use for NP|Change from baseline in sinus severity score by Quantitative CT analysis|Other Pre-specified Outcome Measures:|Numbers of adverse events (AEs) and serious adverse events (SAEs)|Presence and absence of benralizumab anti-drug antibodies (ADA)","Week 56 (visit 11)|by Week 56 (visit 11)","information.center@astrazeneca.com","AstraZeneca Clinical Study Information Center","1-877-240-9479","Graz, Austria, 8036 Research SiteInnsbruck, Austria, 6020 Research SiteLinz, Austria, 4010 Research SiteSalzburg, Austria, 5020 Research SiteWien, Austria, 1090|Brussels, Belgium, 1200 Research SiteGent, Belgium, 9000 Research SiteLeuven, Belgium, 3000|Vancouver, British Columbia, Canada, V5Z 1M9|Hamilton, Ontario, Canada, L8N 3Z5 Research SiteLondon, Ontario, Canada, N6A 4V2 Research SiteMississauga, Ontario, Canada, L5A 3V4 Research SiteOttawa, Ontario, Canada, K1G 6C6|Montreal, Quebec, Canada, H2X 3E4 Research SiteMontreal, Quebec, Canada, H3G 1L5 Research SiteMontreal, Quebec, Canada, H4A 3J1 Research SiteQuebec City, Quebec, Canada, G1V 4W2 Research SiteTrois-RiviÃ¨res, Quebec, Canada, G8T 7A1|Quebec, Canada, G1V 4G5|Arhus C, Denmark, 8000 Research SiteHillerÃ¸d, Denmark, 3400 Research SiteKÃ¸benhavn Nv, Denmark, 2400 Research SiteKÃ¸ge, Denmark, 4600 Research SiteNÃ¦stved, Denmark, 4700 Research SiteOdense, Denmark, 5000 Research SiteVejle, Denmark, 7100 Research SiteÃ…lborg, Denmark, 9100|Dreieich, Germany, 63303 Research SiteDresden, Germany, 01307 Research SiteDÃ¼sseldorf, Germany, 40225 Research SiteGÃ¶ttingen, Germany, 37073 Research SiteMÃ¼nster, Germany, 48149|Budapest, Hungary, 1083 Research SiteBudapest, Hungary, 1106 Research SiteDebrecen, Hungary, 4032 Research SiteEger, Hungary, 3300 Research SiteNyÃ­regyhÃ¡za, Hungary, 4400 Research SiteVeszprÃ©m, Hungary, 8200|Nadarzyn, Poland, 05-830 Research SiteStrzelce Opolskie, Poland, 47-100 Research SiteWarszawa, Poland, 02-547 Research SiteWrocÅ‚aw, Poland, 53-301 Research SiteÅ\u0081Ã³dÅº, Poland, 90-153|Peoria, Arizona, United States, 85381|Fresno, California, United States, 93720 Research SiteLa Mesa, California, United States, 91942 Research SiteLos Angeles, California, United States, 90048 Research SiteLos Angeles, California, United States, 90095-1624 Research SiteOrange, California, United States, 92868 Research SiteRoseville, California, United States, 95661 Research SiteWalnut Creek, California, United States, 94598|Centennial, Colorado, United States, 80112 United States, District Of Columbia Research SiteWashington, District Of Columbia, United States, 20037|Boca Raton, Florida, United States, 33487|Atlanta, Georgia, United States, 30342|Chicago, Illinois, United States, 60611 Research SiteChicago, Illinois, United States, 60647|West Des Moines, Iowa, United States, 50265|Kansas City, Kansas, United States, 66160|Louisville, Kentucky, United States, 40207|Baltimore, Maryland, United States, 21224|Boston, Massachusetts, United States, 02111|Lincoln, Nebraska, United States, 68505|New Windsor, New York, United States, 12553 Research SiteNew York, New York, United States, 10001 Research SiteNew York, New York, United States, 10011 Research SiteNew York, New York, United States, 10016 Research SiteNew York, New York, United States, 10022 Research SiteNew York, New York, United States, 10028 Research SiteNew York, New York, United States, 10128 Research SiteWhite Plains, New York, United States, 10601|Charlotte, North Carolina, United States, 28210 Research SiteConcord, North Carolina, United States, 28025 Research SitePinehurst, North Carolina, United States, 28374 Research SiteWinston-Salem, North Carolina, United States, 27103|Middleburg Heights, Ohio, United States, 44130|Oklahoma City, Oklahoma, United States, 73120|Portland, Oregon, United States, 97239|Bethlehem, Pennsylvania, United States, 18017 Research SitePhiladelphia, Pennsylvania, United States, 19111 Research SitePittsburgh, Pennsylvania, United States, 15213|Charleston, South Carolina, United States, 29425|Conroe, Texas, United States, 77304 Research SiteHouston, Texas, United States, 77030|North Logan, Utah, United States, 84341 Research SiteSaint George, Utah, United States, 84790|Charlottesville, Virginia, United States, 22903 Research SiteNorfolk, Virginia, United States, 23507 Research SiteRichmond, Virginia, United States, 23236-1968|Fairmont, West Virginia, United States, 26554","Arizona|California|Colorado|Florida|Georgia|Illinois|Iowa|Kansas|Kentucky|Maryland|Massachusetts|Nebraska|New York|North Carolina|Ohio|Oklahoma|Oregon|Pennsylvania|South Carolina|Texas|Utah|Virginia|West Virginia","Austria|Belgium|Canada|Denmark|Germany|Hungary|Poland|United States","Research Site|British Columbia Research Site|Ontario Research Site|Quebec Research Site",{"$nulls":4},"2018-01-22","2020-05-25T16:37:16.198","2020-05-26T17:10:42.972","NCT03401229"]
["5ecbf43cfe30261b1a048294","NCT03401229","2018-04-20","AstraZeneca","AZN","Recruiting","Efficacy and Safety Study of Benralizumab for Patients With Severe Nasal Polyposis (OSTRO)","Benralizumab|Mometasone","IL5 Inhibitor|GR Agonist","No",null,"No",null,"Phase 3",2,400,"Anticipated","2018-01-15","2020-02-05",{"$nulls":5},"The aim of this present study is to investigate the use of benralizumab as treatment for severe nasal polyposis. The effect of benralizumab on nasal polyps will be assessed over a 56 weeks of treatment period in patients with severe bilateral nasal polyposis who are still symptomatic despite standard of care therapy, i.e current use of intranasal corticosteroids (INCS) and prior surgery and/or use of systemic corticosteroids. The first 200 patients that complete the 56-week treatment will have a 6 month follow-up (FU) period without dosing.",null,"A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Phase 3 Efficacy and Safety Study Of Benralizumab in Patients With Severe Nasal Polyposis","D3252C00001","Nasal Polyposis","Nasal Polyposis","Nose Diseases","Respiratory","Experimental|Placebo Comparator","Benralizumab 30mg SC + MF|Placebo SC + MF","SC - subcutaneously MF - Mometasone Furoate","Biological","Benralizumab 30 mg SC + Mometasone Furoate|Matching placebo SC + Mometasone Furoate",null,null,"Benralizumab 30mg SC + MF|Placebo SC + MF","\n\n 1.  Capable of giving signed informed consent, which includes compliance with the requirements and restrictions, listed in the informed consent form (ICF) and in protocol.\n 2.  Provision of signed and dated, written informed consent form (ICF) prior to any mandatory study specific procedures, sampling, and analyses and according to international guidelines and/or applicable European Union (EU) guidelines.\n 3.  Provision of signed and dated written genetic informed consent in patients that agree to participate in the genetic sampling, prior to collection of sample for genetic analysis.\n 4.  Female or male patients aged 18 to 75 years inclusive, at the time of signing the ICF.\n 5.  Patients with bilateral sinonasal polyposis that, despite treatment with intranasal corticosteroids (INCS) and a history of treatment with systemic (SCS -oral, parenteral) or prior surgery for nasal polyposis (NP), have severity consistent with a need for surgery as described by: * A minimum bilateral Nasal Polyp Score (NPS) of 5 out of a maximum score of 8 (with a unilateral score of at least 2 for each nostril;\n      * Ongoing symptoms for at least 12 weeks prior to V1;\n      * Patient-reported moderate to severe nasal blockage score (NBS) 2 or 3 over the 2-weeks prior to V1 (2-week recall assessment of symptoms, scores 0-none to 3-severe).\n     \n     \n 6.  SNOT-22 total score > 30 at enrolment.Patient must meet the following criteria (points 7-10) at the randomization visit:\n     \n     \n 7.  At least 8 days of evaluable daily diary data in the 14-day period prior to randomization (baseline bi-weekly mean score collected from study Day -13 to study Day 0).\n 8.  At randomization, a bi-weekly mean NBS â‰¥ 1.5.\n 9.  SNOT-22 total score > 30 at randomization.\n 10. At least 70% compliance with INCS during the run-in period based on daily diary.\n 11. Patients with a minimum weight of 40kg.\n 12. Negative serum pregnancy test result and a negative urine pregnancy test at randomization for female patients of childbearing potential.\n 13. Women of childbearing potential (WOCBP) must use an effective form of birth control as defined in the Clinical Study Protocol (CSP).\n\n15. All male patients who are sexually active must agree to use an acceptable method of contraception(condom with or without spermicide)\n\n","\n\n 1.  Patients who have undergone any nasal and/or sinus surgery within 6 months before screening.\n 2.  Patients with conditions or concomitant disease that makes them non evaluable for the co-primary efficacy endpoint such as: * Unilateral antrochoanal polyps;\n      * Nasal septal deviation that occludes at least one nostril;\n      * Acute sinusitis, nasal infection, or upper respiratory infection at screening or in the 2 weeks before screening;\n      * Current rhinitis medicamentosa;\n      * Allergic fungal rhinosinusitis;\n      * Nasal cavity tumors.\n     \n     \n 3.  Clinically important comorbidities that could confound interpretation of clinical efficacy results including, but not limited to: active upper or lower respiratory tract infection, cystic fibrosis, primary ciliary dyskinesia, eosinophilic diseases other than asthma (e.g. allergic bronchopulmonary aspergillosis/mycosis, eosinophilic granulomatosis with polyangitis [Churg-Strauss syndrome], hypereosinophilic syndromes), granulomatosis with polyangitis (Wegener's granulomatosis), Young's syndrome, etc.\n 4.  Any disorder, including but not limited to: cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric, or major physical impairment that is not stable in the opinion of the Investigator or AstraZeneca and could: * Affect the safety of the patient throughout the study;\n      * Influence the findings of the studies or their interpretations;\n      * Impede the patient's ability to complete the entire duration of study.\n     \n     \n 5.  Patients experiencing an asthma exacerbation requiring systemic (oral and/or parenteral) corticosteroids treatment or hospitalization (>24hrs) for treatment of asthma within 3 months prior to screening or during screening.\n 6.  History of anaphylaxis to any biologic therapy or vaccine.\n 7.  Known history of allergy or reaction to any component of the Investigational Product (IP) formulation.\n 8.  History of Guillain-BarrÃ© syndrome.\n 9.  A helminth parasitic infection diagnosed within 24 weeks prior to the date informed consent is obtained that has not been treated with, or has failed to respond to standard of care therapy.\n 10. Current malignancy, or history of malignancy, except for: - Patients who have had basal cell carcinoma, localized squamous cell carcinoma of the skin, or in situ carcinoma of the cervix are eligible provided that patient is in remission and curative therapy was completed at least 12 months prior to the date informed consent, and assent, when applicable was obtained; - Patients who have had other malignancies are eligible provided that the patient is in remission and curative therapy was completed at least 5 years prior to the date of informed consent, and assent, when applicable, was obtained.\n 11. Any clinically significant cardiac disease or any electrocardiogram (ECG) abnormality obtained during the screening/run-in period, which may put the patient at risk or interfere with study assessments.\n 12. Positive hepatitis B surface antigen, or hepatitis C virus antibody serology (confirmed by additional testing, eg, hepatitis C RNA test, if indicated), or a positive medical history for hepatitis B or C. Patients with history of hepatitis B vaccination without history of hepatitis B are allowed to enrol.\n 13. History of known immunodeficiency disorder, including a positive human immunodeficiency virus (HIV) test.\n 14. Infection requiring systemic antibiotics within 14 days prior to the date informed consent is obtained or during the screening/run-in period.\n 15. Use of immunosuppressive medication (including but not limited to: methotrexate, troleandomycin, cyclosporine, azathioprine, systemic corticosteroid for condition other than short course for nasal polyps, or any experimental anti-inflammatory therapy) within 3 months prior to the date informed consent is obtained.\n 16. Receipt of any marketed or investigational biologic (monoclonal or polyclonal antibody) within 4 months or 5 half-lives prior to the date informed consent, is obtained, whichever is longer.\n 17. Previous receipt of mepolizumab, reslizumab, dupilumab, or benralizumab.\n 18. Receipt of immunoglobulin or blood products within 30 days prior to the date informed consent is obtained.\n 19. Receipt of live attenuated vaccines 30 days prior to the date of randomization.\n 20. Receipt of any investigational drug within 30 days or 5 half-lives prior to randomization, whichever is longer.\n 21. Receipt of burst of systemic corticosteroid within 2 months before screening, during screening or are scheduled to receive systemic corticosteroid during the study period.\n 22. Receipt of leukotriene antagonist/modifiers for patients who were not on continuous treatment for â‰¥30 days prior visit 1.\n 23. Concurrent enrolment in another clinical drug interventional trial.\n 24. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level > 3 times the upper limit of normal (ULN) confirmed during screening period.\n 25. Previous randomization in the present study.\n 26. Planned surgical procedures at the time of the study enrolment and randomization, including a scheduled NP surgery.\n 27. Initiated or is being maintained on an aspirin desensitization regimen for the management of aspirin exacerbated respiratory disease (AERD) at the time of study enrolment or during the run-in period.\n 28. For women only - currently pregnant (or intend to become pregnant), breastfeeding or lactating.",{"$nulls":4},"Actual","2018-01-17","Actual","Anticipated","2020-02-05","Anticipated","2018-04-01","2017-12-13","2018-01-09","2018-04-19","No","Polyps\nNasal polyps\nNasal polyposis\nNose diseases\nRespiratory tract diseases\nOtorhinolaryngologic diseases\nBenralizumab\nMometasone furoate","Interventional","Treatment","Parallel Assignment","Triple (Participant, Care Provider, Investigator)","Randomized","18 Years","75 Years","All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"2017-003675-61","EudraCT Number","Effect of benralizumab on nasal polyp burden|Effect of benralizumab on patient reported nasal blockage (NB)","Change from baseline in endoscopic total nasal polyp score (NPS). NPS (maximum 8) is the sum of the right and left nostril scores|Change from baseline in mean nasal blockage score (NBS). NBS is assessed in daily diary by asking patients to rate the severity of their worst nasal blockage over the past 24 hours using the following response options: 0 - None; 1 - Mild; 2 - Moderate; 3 - Severe","Week 56 (visit 11)","Effect of benralizumab on disease specific health-related quality of life (HRQoL)|Effect of benralizumab on nasal polyp (NP) surgery|Proportion of NP Surgery|Systemic corticosteroids (SCS) use for relief of nasal symptoms|Symptoms associated with nasal polyps|Sinus opacification by computed tomography (CT) scan (subset of patients)|Patient-reported general health status|Other Pre-specified Outcome Measures:|Assessment of the safety of benralizumab|Assessment of the immunogenicity of benralizumab","Change from baseline in SinoNasal Outcome Test (SNOT-22) score. SNOT-22 captures patient-reported physical problems, functional limitations, and emotional consequences of sinonasal condition. It`s patient-reported symptom severity and symptom impact over the past 2 weeks and are captured via a 6-point scale (0- No Problem to 5- Problem as bad as it can be). The total score is the sum of item scores and has a range from 0 to 110|Time to first NP surgery|Proportion of patients with surgery for NP|Proportion of patients with SCS use for NP|Time to first SCS course for NP|Change from baseline in nasal symptom score(s) as captured in the daily diary. Patients report the severity of symptom related to NP at its worst using a 4-point verbal rating scale (0-None to 3-Severe).|Sense of smell captured as change from baseline in University of Pennsylvania Smell Identification Test (UPSIT) score.\n\nIt is a quantitative test of olfactory function which uses microencapsulated odorants that are released by scratching standardized odor-impregnated test booklets. Four booklets each with 10 odorants each are used for the test. Patients are asked to identify the odor using multiple choice format which lists different possibilities. Scores are based on number of correctly identified odors (score range 0 to 40).|Change from baseline in Lund Mackay score|Change from baseline in Short Form 36-item Health survey, Version 2 (SF-36v2)|Total SCS dose used|Number of courses of SCS for NP|Total duration of SCS use for NP|Change from baseline in sinus severity score by Quantitative CT analysis|Other Pre-specified Outcome Measures:|Numbers of adverse events (AEs) and serious adverse events (SAEs)|Presence and absence of benralizumab anti-drug antibodies (ADA)","Week 56 (visit 11)|by Week 56 (visit 11)","information.center@astrazeneca.com","AstraZeneca Clinical Study Information Center","1-877-240-9479","Graz, Austria, 8036 Research SiteInnsbruck, Austria, 6020 Research SiteLinz, Austria, 4010 Research SiteSalzburg, Austria, 5020 Research SiteSt. PÃ¶lten, Austria, 3100 Research SiteWien, Austria, 1090|Brussels, Belgium, 1200 Research SiteGent, Belgium, 9000 Research SiteLeuven, Belgium, 3000|Vancouver, British Columbia, Canada, V5Z 1M9|Hamilton, Ontario, Canada, L8N 3Z5 Research SiteLondon, Ontario, Canada, N6A 4V2 Research SiteMississauga, Ontario, Canada, L5A 3V4 Research SiteOttawa, Ontario, Canada, K1G 6C6|Montreal, Quebec, Canada, H2X 3E4 Research SiteMontreal, Quebec, Canada, H3G 1L5 Research SiteMontreal, Quebec, Canada, H4A 3J1 Research SiteQuebec City, Quebec, Canada, G1V 4W2 Research SiteTrois-RiviÃ¨res, Quebec, Canada, G8T 7A1|Quebec, Canada, G1V 4G5|Arhus C, Denmark, 8000 Research SiteHillerÃ¸d, Denmark, 3400 Research SiteHvidovre, Denmark, 2650 Research SiteKÃ¸benhavn Nv, Denmark, 2400 Research SiteKÃ¸ge, Denmark, 4600 Research SiteNÃ¦stved, Denmark, 4700 Research SiteOdense, Denmark, 5000 Research SiteVejle, Denmark, 7100 Research SiteÃ…lborg, Denmark, 9100|Berlin, Germany, 13353 Research SiteDreieich, Germany, 63303 Research SiteDresden, Germany, 01307 Research SiteDÃ¼sseldorf, Germany, 40225 Research SiteGÃ¶ttingen, Germany, 37073 Research SiteHeidelberg, Germany, 69120 Research SiteLÃ¼beck, Germany, 23538 Research SiteMÃ¼nster, Germany, 48149 Research SiteWiesbaden, Germany, 65183|Budapest, Hungary, 1083 Research SiteBudapest, Hungary, 1106 Research SiteDebrecen, Hungary, 4032 Research SiteEger, Hungary, 3300 Research SiteNyÃ­regyhÃ¡za, Hungary, 4400 Research SiteVeszprÃ©m, Hungary, 8200|Nadarzyn, Poland, 05-830 Research SiteStrzelce Opolskie, Poland, 47-100 Research SiteWarszawa, Poland, 02-547 Research SiteWrocÅ‚aw, Poland, 53-301 Research SiteÅ\u0081Ã³dÅº, Poland, 90-153|Peoria, Arizona, United States, 85381|Fresno, California, United States, 93720 Research SiteLa Mesa, California, United States, 91942 Research SiteLos Angeles, California, United States, 90048 Research SiteLos Angeles, California, United States, 90095-1624 Research SiteOrange, California, United States, 92868 Research SiteRoseville, California, United States, 95661 Research SiteWalnut Creek, California, United States, 94598|Centennial, Colorado, United States, 80112 Research SiteGlenwood Springs, Colorado, United States, 81601 United States, District Of Columbia Research SiteWashington, District Of Columbia, United States, 20037|Boca Raton, Florida, United States, 33487|Decatur, Georgia, United States, 30030|Chicago, Illinois, United States, 60611 Research SiteChicago, Illinois, United States, 60647|West Des Moines, Iowa, United States, 50265|Kansas City, Kansas, United States, 66160|Louisville, Kentucky, United States, 40207|Baltimore, Maryland, United States, 21224|Boston, Massachusetts, United States, 02111|Lincoln, Nebraska, United States, 68505|New Windsor, New York, United States, 12553 Research SiteNew York, New York, United States, 10001 Research SiteNew York, New York, United States, 10011 Research SiteNew York, New York, United States, 10016 Research SiteNew York, New York, United States, 10016 Research SiteNew York, New York, United States, 10022 Research SiteNew York, New York, United States, 10028 Research SiteNew York, New York, United States, 10128 Research SiteWhite Plains, New York, United States, 10601|Charlotte, North Carolina, United States, 28210 Research SiteConcord, North Carolina, United States, 28025 Research SitePinehurst, North Carolina, United States, 28374 Research SiteWinston-Salem, North Carolina, United States, 27103|Middleburg Heights, Ohio, United States, 44130|Oklahoma City, Oklahoma, United States, 73120 Research SiteOklahoma City, Oklahoma, United States, 73120|Portland, Oregon, United States, 97239|Bethlehem, Pennsylvania, United States, 18017 Research SitePhiladelphia, Pennsylvania, United States, 19104 Research SitePhiladelphia, Pennsylvania, United States, 19107 Research SitePhiladelphia, Pennsylvania, United States, 19111 Research SitePittsburgh, Pennsylvania, United States, 15213|Charleston, South Carolina, United States, 29425|Conroe, Texas, United States, 77304 Research SiteHouston, Texas, United States, 77030|North Logan, Utah, United States, 84341 Research SiteSaint George, Utah, United States, 84790|Charlottesville, Virginia, United States, 22903 Research SiteNorfolk, Virginia, United States, 23507 Research SiteRichmond, Virginia, United States, 23236-1968|Fairmont, West Virginia, United States, 26554","Arizona|California|Colorado|Florida|Georgia|Illinois|Iowa|Kansas|Kentucky|Maryland|Massachusetts|Nebraska|New York|North Carolina|Ohio|Oklahoma|Oregon|Pennsylvania|South Carolina|Texas|Utah|Virginia|West Virginia","Austria|Belgium|Canada|Denmark|Germany|Hungary|Poland|United States","Research Site|British Columbia Research Site|Ontario Research Site|Quebec Research Site",{"$nulls":4},"2018-04-19","2020-05-25T16:37:16.312","2020-05-26T17:10:42.972","NCT03401229"]
["5ecbf43c11702c1b1b916aa5","NCT03401229","2018-05-17","AstraZeneca","AZN","Recruiting","Efficacy and Safety Study of Benralizumab for Patients With Severe Nasal Polyposis (OSTRO)","Benralizumab|Mometasone","IL5 Inhibitor|GR Agonist","No",null,"No",null,"Phase 3",2,400,"Anticipated","2018-01-15","2020-02-05",{"$nulls":5},"The aim of this present study is to investigate the use of benralizumab as treatment for severe nasal polyposis. The effect of benralizumab on nasal polyps will be assessed over a 56 weeks of treatment period in patients with severe bilateral nasal polyposis who are still symptomatic despite standard of care therapy, i.e current use of intranasal corticosteroids (INCS) and prior surgery and/or use of systemic corticosteroids. The first 200 patients that complete the 56-week treatment will have a 6 month follow-up (FU) period without dosing.",null,"A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Phase 3 Efficacy and Safety Study Of Benralizumab in Patients With Severe Nasal Polyposis","D3252C00001","Nasal Polyposis","Nasal Polyposis","Nose Diseases","Respiratory","Experimental|Placebo Comparator","Benralizumab 30mg SC + MF|Placebo SC + MF","SC - subcutaneously MF - Mometasone Furoate","Biological","Benralizumab 30 mg SC + Mometasone Furoate|Matching placebo SC + Mometasone Furoate",null,null,"Benralizumab 30mg SC + MF|Placebo SC + MF","\n\n 1.  Capable of giving signed informed consent, which includes compliance with the requirements and restrictions, listed in the informed consent form (ICF) and in protocol.\n 2.  Provision of signed and dated, written informed consent form (ICF) prior to any mandatory study specific procedures, sampling, and analyses and according to international guidelines and/or applicable European Union (EU) guidelines.\n 3.  Provision of signed and dated written genetic informed consent in patients that agree to participate in the genetic sampling, prior to collection of sample for genetic analysis.\n 4.  Female or male patients aged 18 to 75 years inclusive, at the time of signing the ICF.\n 5.  Patients with bilateral sinonasal polyposis that, despite treatment with intranasal corticosteroids (INCS) and a history of treatment with systemic (SCS -oral, parenteral) or prior surgery for nasal polyposis (NP), have severity consistent with a need for surgery as described by: * A minimum bilateral Nasal Polyp Score (NPS) of 5 out of a maximum score of 8 (with a unilateral score of at least 2 for each nostril;\n      * Ongoing symptoms for at least 12 weeks prior to V1;\n      * Patient-reported moderate to severe nasal blockage score (NBS) 2 or 3 over the 2-weeks prior to V1 (2-week recall assessment of symptoms, scores 0-none to 3-severe).\n     \n     \n 6.  SNOT-22 total score > 30 at enrolment.Patient must meet the following criteria (points 7-10) at the randomization visit:\n     \n     \n 7.  At least 8 days of evaluable daily diary data in the 14-day period prior to randomization (baseline bi-weekly mean score collected from study Day -13 to study Day 0).\n 8.  At randomization, a bi-weekly mean NBS â‰¥ 1.5.\n 9.  SNOT-22 total score > 30 at randomization.\n 10. At least 70% compliance with INCS during the run-in period based on daily diary.\n 11. Patients with a minimum weight of 40kg.\n 12. Negative serum pregnancy test result and a negative urine pregnancy test at randomization for female patients of childbearing potential.\n 13. Women of childbearing potential (WOCBP) must use an effective form of birth control as defined in the Clinical Study Protocol (CSP).\n\n15. All male patients who are sexually active must agree to use an acceptable method of contraception(condom with or without spermicide)\n\n","\n\n 1.  Patients who have undergone any nasal and/or sinus surgery within 6 months before screening.\n 2.  Patients with conditions or concomitant disease that makes them non evaluable for the co-primary efficacy endpoint such as: * Unilateral antrochoanal polyps;\n      * Nasal septal deviation that occludes at least one nostril;\n      * Acute sinusitis, nasal infection, or upper respiratory infection at screening or in the 2 weeks before screening;\n      * Current rhinitis medicamentosa;\n      * Allergic fungal rhinosinusitis;\n      * Nasal cavity tumors.\n     \n     \n 3.  Clinically important comorbidities that could confound interpretation of clinical efficacy results including, but not limited to: active upper or lower respiratory tract infection, cystic fibrosis, primary ciliary dyskinesia, eosinophilic diseases other than asthma (e.g. allergic bronchopulmonary aspergillosis/mycosis, eosinophilic granulomatosis with polyangitis [Churg-Strauss syndrome], hypereosinophilic syndromes), granulomatosis with polyangitis (Wegener's granulomatosis), Young's syndrome, etc.\n 4.  Any disorder, including but not limited to: cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric, or major physical impairment that is not stable in the opinion of the Investigator or AstraZeneca and could: * Affect the safety of the patient throughout the study;\n      * Influence the findings of the studies or their interpretations;\n      * Impede the patient's ability to complete the entire duration of study.\n     \n     \n 5.  Patients experiencing an asthma exacerbation requiring systemic (oral and/or parenteral) corticosteroids treatment or hospitalization (>24hrs) for treatment of asthma within 3 months prior to screening or during screening.\n 6.  History of anaphylaxis to any biologic therapy or vaccine.\n 7.  Known history of allergy or reaction to any component of the Investigational Product (IP) formulation.\n 8.  History of Guillain-BarrÃ© syndrome.\n 9.  A helminth parasitic infection diagnosed within 24 weeks prior to the date informed consent is obtained that has not been treated with, or has failed to respond to standard of care therapy.\n 10. Current malignancy, or history of malignancy, except for: - Patients who have had basal cell carcinoma, localized squamous cell carcinoma of the skin, or in situ carcinoma of the cervix are eligible provided that patient is in remission and curative therapy was completed at least 12 months prior to the date informed consent, and assent, when applicable was obtained; - Patients who have had other malignancies are eligible provided that the patient is in remission and curative therapy was completed at least 5 years prior to the date of informed consent, and assent, when applicable, was obtained.\n 11. Any clinically significant cardiac disease or any electrocardiogram (ECG) abnormality obtained during the screening/run-in period, which may put the patient at risk or interfere with study assessments.\n 12. Positive hepatitis B surface antigen, or hepatitis C virus antibody serology (confirmed by additional testing, eg, hepatitis C RNA test, if indicated), or a positive medical history for hepatitis B or C. Patients with history of hepatitis B vaccination without history of hepatitis B are allowed to enrol.\n 13. History of known immunodeficiency disorder, including a positive human immunodeficiency virus (HIV) test.\n 14. Infection requiring systemic antibiotics within 14 days prior to the date informed consent is obtained or during the screening/run-in period.\n 15. Use of immunosuppressive medication (including but not limited to: methotrexate, troleandomycin, cyclosporine, azathioprine, systemic corticosteroid for condition other than short course for nasal polyps, or any experimental anti-inflammatory therapy) within 3 months prior to the date informed consent is obtained.\n 16. Receipt of any marketed or investigational biologic (monoclonal or polyclonal antibody) within 4 months or 5 half-lives prior to the date informed consent, is obtained, whichever is longer.\n 17. Previous receipt of mepolizumab, reslizumab, dupilumab, or benralizumab.\n 18. Receipt of immunoglobulin or blood products within 30 days prior to the date informed consent is obtained.\n 19. Receipt of live attenuated vaccines 30 days prior to the date of randomization.\n 20. Receipt of any investigational drug within 30 days or 5 half-lives prior to randomization, whichever is longer.\n 21. Receipt of burst of systemic corticosteroid within 2 months before screening, during screening or are scheduled to receive systemic corticosteroid during the study period.\n 22. Receipt of leukotriene antagonist/modifiers for patients who were not on continuous treatment for â‰¥30 days prior visit 1.\n 23. Concurrent enrolment in another clinical drug interventional trial.\n 24. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level > 3 times the upper limit of normal (ULN) confirmed during screening period.\n 25. Previous randomization in the present study.\n 26. Planned surgical procedures at the time of the study enrolment and randomization, including a scheduled NP surgery.\n 27. Initiated or is being maintained on an aspirin desensitization regimen for the management of aspirin exacerbated respiratory disease (AERD) at the time of study enrolment or during the run-in period.\n 28. For women only - currently pregnant (or intend to become pregnant), breastfeeding or lactating.",{"$nulls":4},"Actual","2018-01-17","Actual","Anticipated","2020-02-05","Anticipated","2018-05-01","2017-12-13","2018-01-09","2018-05-16","No","Polyps\nNasal polyps\nNasal polyposis\nNose diseases\nRespiratory tract diseases\nOtorhinolaryngologic diseases\nBenralizumab\nMometasone furoate","Interventional","Treatment","Parallel Assignment","Triple (Participant, Care Provider, Investigator)","Randomized","18 Years","75 Years","All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"2017-003675-61","EudraCT Number","Effect of benralizumab on nasal polyp burden|Effect of benralizumab on patient reported nasal blockage (NB)","Change from baseline in endoscopic total nasal polyp score (NPS). NPS (maximum 8) is the sum of the right and left nostril scores|Change from baseline in mean nasal blockage score (NBS). NBS is assessed in daily diary by asking patients to rate the severity of their worst nasal blockage over the past 24 hours using the following response options: 0 - None; 1 - Mild; 2 - Moderate; 3 - Severe","Week 56 (visit 11)","Effect of benralizumab on disease specific health-related quality of life (HRQoL)|Effect of benralizumab on nasal polyp (NP) surgery|Proportion of NP Surgery|Systemic corticosteroids (SCS) use for relief of nasal symptoms|Symptoms associated with nasal polyps|Sinus opacification by computed tomography (CT) scan (subset of patients)|Patient-reported general health status|Other Pre-specified Outcome Measures:|Assessment of the safety of benralizumab|Assessment of the immunogenicity of benralizumab","Change from baseline in SinoNasal Outcome Test (SNOT-22) score. SNOT-22 captures patient-reported physical problems, functional limitations, and emotional consequences of sinonasal condition. It`s patient-reported symptom severity and symptom impact over the past 2 weeks and are captured via a 6-point scale (0- No Problem to 5- Problem as bad as it can be). The total score is the sum of item scores and has a range from 0 to 110|Time to first NP surgery|Proportion of patients with surgery for NP|Proportion of patients with SCS use for NP|Time to first SCS course for NP|Change from baseline in nasal symptom score(s) as captured in the daily diary. Patients report the severity of symptom related to NP at its worst using a 4-point verbal rating scale (0-None to 3-Severe).|Sense of smell captured as change from baseline in University of Pennsylvania Smell Identification Test (UPSIT) score.\n\nIt is a quantitative test of olfactory function which uses microencapsulated odorants that are released by scratching standardized odor-impregnated test booklets. Four booklets each with 10 odorants each are used for the test. Patients are asked to identify the odor using multiple choice format which lists different possibilities. Scores are based on number of correctly identified odors (score range 0 to 40).|Change from baseline in Lund Mackay score|Change from baseline in Short Form 36-item Health survey, Version 2 (SF-36v2)|Total SCS dose used|Number of courses of SCS for NP|Total duration of SCS use for NP|Change from baseline in sinus severity score by Quantitative CT analysis|Other Pre-specified Outcome Measures:|Numbers of adverse events (AEs) and serious adverse events (SAEs)|Presence and absence of benralizumab anti-drug antibodies (ADA)","Week 56 (visit 11)|by Week 56 (visit 11)","information.center@astrazeneca.com","AstraZeneca Clinical Study Information Center","1-877-240-9479","Graz, Austria, 8036 Research SiteInnsbruck, Austria, 6020 Research SiteLinz, Austria, 4010 Research SiteSalzburg, Austria, 5020 Research SiteSt. PÃ¶lten, Austria, 3100 Research SiteWien, Austria, 1090|Brussels, Belgium, 1200 Research SiteGent, Belgium, 9000 Research SiteLeuven, Belgium, 3000|Vancouver, British Columbia, Canada, V5Z 1M9|Hamilton, Ontario, Canada, L8N 3Z5 Research SiteLondon, Ontario, Canada, N6A 4V2 Research SiteMississauga, Ontario, Canada, L5A 3V4 Research SiteOttawa, Ontario, Canada, K1G 6C6|Montreal, Quebec, Canada, H2X 3E4 Research SiteMontreal, Quebec, Canada, H3G 1L5 Research SiteMontreal, Quebec, Canada, H4A 3J1 Research SiteQuebec City, Quebec, Canada, G1V 4W2 Research SiteTrois-RiviÃ¨res, Quebec, Canada, G8T 7A1|Quebec, Canada, G1V 4G5|Arhus C, Denmark, 8000 Research SiteHillerÃ¸d, Denmark, 3400 Research SiteHvidovre, Denmark, 2650 Research SiteKÃ¸benhavn Nv, Denmark, 2400 Research SiteKÃ¸ge, Denmark, 4600 Research SiteNÃ¦stved, Denmark, 4700 Research SiteOdense, Denmark, 5000 Research SiteVejle, Denmark, 7100 Research SiteÃ…lborg, Denmark, 9100|Berlin, Germany, 13353 Research SiteDreieich, Germany, 63303 Research SiteDresden, Germany, 01307 Research SiteDÃ¼sseldorf, Germany, 40225 Research SiteGÃ¶ttingen, Germany, 37073 Research SiteHeidelberg, Germany, 69120 Research SiteLÃ¼beck, Germany, 23538 Research SiteMÃ¼nster, Germany, 48149 Research SiteWiesbaden, Germany, 65183|Budapest, Hungary, 1083 Research SiteBudapest, Hungary, 1106 Research SiteDebrecen, Hungary, 4032 Research SiteEger, Hungary, 3300 Research SiteNyÃ­regyhÃ¡za, Hungary, 4400 Research SiteVeszprÃ©m, Hungary, 8200|Nadarzyn, Poland, 05-830 Research SiteStrzelce Opolskie, Poland, 47-100 Research SiteWarszawa, Poland, 02-547 Research SiteWrocÅ‚aw, Poland, 53-301 Research SiteÅ\u0081Ã³dÅº, Poland, 90-153|Peoria, Arizona, United States, 85381|Fresno, California, United States, 93720 Research SiteLa Mesa, California, United States, 91942 Research SiteLos Angeles, California, United States, 90048 Research SiteLos Angeles, California, United States, 90095-1624 Research SiteOrange, California, United States, 92868 Research SiteRoseville, California, United States, 95661 Research SiteWalnut Creek, California, United States, 94598|Centennial, Colorado, United States, 80112 Research SiteGlenwood Springs, Colorado, United States, 81601 United States, District Of Columbia Research SiteWashington, District Of Columbia, United States, 20037|Boca Raton, Florida, United States, 33487|Decatur, Georgia, United States, 30030|Chicago, Illinois, United States, 60611 Research SiteChicago, Illinois, United States, 60647|West Des Moines, Iowa, United States, 50265|Kansas City, Kansas, United States, 66160|Louisville, Kentucky, United States, 40207|Baltimore, Maryland, United States, 21224|Boston, Massachusetts, United States, 02111|Lincoln, Nebraska, United States, 68505|New Windsor, New York, United States, 12553 Research SiteNew York, New York, United States, 10001 Research SiteNew York, New York, United States, 10011 Research SiteNew York, New York, United States, 10016 Research SiteNew York, New York, United States, 10016 Research SiteNew York, New York, United States, 10022 Research SiteNew York, New York, United States, 10028 Research SiteNew York, New York, United States, 10128 Research SiteWhite Plains, New York, United States, 10601|Charlotte, North Carolina, United States, 28210 Research SiteConcord, North Carolina, United States, 28025 Research SitePinehurst, North Carolina, United States, 28374 Research SiteWinston-Salem, North Carolina, United States, 27103|Middleburg Heights, Ohio, United States, 44130|Oklahoma City, Oklahoma, United States, 73120|Portland, Oregon, United States, 97239|Bethlehem, Pennsylvania, United States, 18017 Research SitePhiladelphia, Pennsylvania, United States, 19104 Research SitePhiladelphia, Pennsylvania, United States, 19107 Research SitePhiladelphia, Pennsylvania, United States, 19111 Research SitePittsburgh, Pennsylvania, United States, 15213|Charleston, South Carolina, United States, 29425|Conroe, Texas, United States, 77304 Research SiteHouston, Texas, United States, 77030|North Logan, Utah, United States, 84341 Research SiteSaint George, Utah, United States, 84790|Charlottesville, Virginia, United States, 22903 Research SiteNorfolk, Virginia, United States, 23507 Research SiteRichmond, Virginia, United States, 23236-1968|Fairmont, West Virginia, United States, 26554","Arizona|California|Colorado|Florida|Georgia|Illinois|Iowa|Kansas|Kentucky|Maryland|Massachusetts|Nebraska|New York|North Carolina|Ohio|Oklahoma|Oregon|Pennsylvania|South Carolina|Texas|Utah|Virginia|West Virginia","Austria|Belgium|Canada|Denmark|Germany|Hungary|Poland|United States","Research Site|British Columbia Research Site|Ontario Research Site|Quebec Research Site",{"$nulls":4},"2018-05-16","2020-05-25T16:37:16.306","2020-05-26T17:10:42.972","NCT03401229"]
["5ecbf43de2561b1b11905d91","NCT03401229","2018-07-18","AstraZeneca","AZN","Recruiting","Efficacy and Safety Study of Benralizumab for Patients With Severe Nasal Polyposis (OSTRO)","Benralizumab|Mometasone","IL5 Inhibitor|GR Agonist","No",null,"No",null,"Phase 3",2,400,"Anticipated","2018-01-15","2020-02-05",{"$nulls":5},"The aim of this present study is to investigate the use of benralizumab as treatment for severe nasal polyposis. The effect of benralizumab on nasal polyps will be assessed over a 56 weeks of treatment period in patients with severe bilateral nasal polyposis who are still symptomatic despite standard of care therapy, i.e current use of intranasal corticosteroids (INCS) and prior surgery and/or use of systemic corticosteroids. The first 200 patients that complete the 56-week treatment will have a 6 month follow-up (FU) period without dosing.",null,"A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Phase 3 Efficacy and Safety Study Of Benralizumab in Patients With Severe Nasal Polyposis","D3252C00001","Nasal Polyposis","Nasal Polyposis","Nose Diseases","Respiratory","Experimental|Placebo Comparator","Benralizumab 30mg SC + MF|Placebo SC + MF","SC - subcutaneously MF - Mometasone Furoate","Biological","Benralizumab 30 mg SC + Mometasone Furoate|Matching placebo SC + Mometasone Furoate",null,null,"Benralizumab 30mg SC + MF|Placebo SC + MF","\n\n 1.  Capable of giving signed informed consent, which includes compliance with the requirements and restrictions, listed in the informed consent form (ICF) and in protocol.\n 2.  Provision of signed and dated, written informed consent form (ICF) prior to any mandatory study specific procedures, sampling, and analyses and according to international guidelines and/or applicable European Union (EU) guidelines.\n 3.  Provision of signed and dated written genetic informed consent in patients that agree to participate in the genetic sampling, prior to collection of sample for genetic analysis.\n 4.  Female or male patients aged 18 to 75 years inclusive, at the time of signing the ICF.\n 5.  Patients with bilateral sinonasal polyposis that, despite treatment with a stable dose of intranasal corticosteroids (INCS) for at least 4 weeks prior to V1, in addition to history of treatment with systemic (SCS -oral, parenteral) or prior surgery for nasal polyposis (NP), have severity consistent with a need for surgery as described by: * A minimum total Nasal Polyp Score (NPS) of 5 out of a maximum score of 8 (with a unilateral score of at least 2 for each nostril) at V1, and continuously maintained at V2 to meet the randomization criterion, as determined by the study Imaging Core Lab;\n      * Ongoing symptoms for at least 12 weeks prior to V1;\n      * Patient-reported moderate to severe nasal blockage score (NBS) 2 or 3 over the 2-weeks prior to V1 (2-week recall assessment of symptoms, scores 0-none to 3-severe).\n     \n     \n 6.  SNOT-22 total score â‰¥ 30 at enrolment.Patient must meet the following criteria (points 7-10) at the randomization visit:\n     \n     \n 7.  At least 8 days of evaluable daily diary data in the 14-day period prior to randomization (baseline bi-weekly mean score collected from study Day -13 to study Day 0).\n 8.  At randomization, a bi-weekly mean NBS â‰¥ 1.5.\n 9.  SNOT-22 total score â‰¥ 30 at randomization.\n 10. At least 70% compliance with INCS during the run-in period based on daily diary.\n 11. Patients with a minimum weight of 40kg.\n 12. Negative serum pregnancy test result and a negative urine pregnancy test at randomization for female patients of childbearing potential.\n 13. Women of childbearing potential (WOCBP) must use an effective form of birth control as defined in the Clinical Study Protocol (CSP).\n\n15. Male subjects who are sexually active must be surgically sterile at least one year prior to Visit 1 or must use an adequate method of contraception (condom or condom with spermicide depending on local regulations) from the first dose of IP until 16 weeks after their last dose. Men with a partner or partners who is (are) not of childbearing potential are exempt of these requirements\n\n","\n\n 1.  Patients who have undergone any nasal and/or sinus surgery within 3 months prior to V1.\n 2.  Patients with conditions or concomitant disease that makes them non evaluable for the co-primary efficacy endpoint such as: * Unilateral antrochoanal polyps;\n      * Nasal septal deviation that occludes at least one nostril;\n      * Acute sinusitis, nasal infection, or upper respiratory infection at screening or in the 2 weeks before screening;\n      * Current rhinitis medicamentosa;\n      * Allergic fungal rhinosinusitis (AFRS) or Allergic fungal sinusitis (AFS);\n      * Nasal cavity tumors.\n     \n     \n 3.  Clinically important comorbidities that could confound interpretation of clinical efficacy results including, but not limited to: active upper or lower respiratory tract infection, cystic fibrosis, primary ciliary dyskinesia, eosinophilic diseases other than asthma (e.g. allergic bronchopulmonary aspergillosis/mycosis, eosinophilic granulomatosis with polyangitis [Churg-Strauss syndrome], hypereosinophilic syndromes), granulomatosis with polyangitis (Wegener's granulomatosis), Young's syndrome, etc.\n 4.  Any disorder, including but not limited to: cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric, or major physical impairment that is not stable in the opinion of the Investigator or AstraZeneca and could: * Affect the safety of the patient throughout the study;\n      * Influence the findings of the studies or their interpretations;\n      * Impede the patient's ability to complete the entire duration of study.\n     \n     \n 5.  Patients experiencing an asthma exacerbation requiring systemic (oral and/or parenteral) corticosteroids treatment or hospitalization (>24hrs) for treatment of asthma within 4 weeks prior to V1.\n 6.  History of anaphylaxis to any biologic therapy or vaccine.\n 7.  Known history of allergy or reaction to any component of the Investigational Product (IP) formulation.\n 8.  History of Guillain-BarrÃ© syndrome.\n 9.  A helminth parasitic infection diagnosed within 24 weeks prior to V1 and has not been treated with, or has failed to respond to standard of care therapy.\n 10. Current malignancy, or history of malignancy, except for: - Patients who have had basal cell carcinoma, localized squamous cell carcinoma of the skin, or in situ carcinoma of the cervix are eligible provided that patient is in remission and curative therapy was completed at least 12 months prior to V1; - Patients who have had other malignancies are eligible provided that the patient is in remission and curative therapy was completed at least 5 years prior to V1.NOTE: Hormonal therapy is allowed. As long as the cancer is in remission for 5 years, the patient is eligible.\n     \n     \n 11. Any clinically significant cardiac disease or any electrocardiogram (ECG) abnormality obtained during the screening/run-in period, which may put the patient at risk or interfere with study assessments.\n 12. Positive hepatitis B surface antigen, or hepatitis C virus antibody serology (confirmed by additional testing, e.g. hepatitis C RNA test, if indicated), or a positive medical history for hepatitis B or C (Note: Patients with history of hepatitis B vaccination without history of hepatitis B are allowed to enroll).\n 13. History of known immunodeficiency disorder, including a positive human immunodeficiency virus (HIV) test.\n 14. Infection requiring systemic antibiotics (Ab) within 14 days prior to V1\n 15. Use of immunosuppressive medication (including but not limited to: methotrexate, troleandomycin, cyclosporine, azathioprine, or any experimental anti-inflammatory therapy) within 3 months prior to V1.\n 16. Receipt of any marketed or investigational biologic products (monoclonal or polyclonal antibody) within 6 months or 5 half-lives prior to the date informed consent, is obtained, whichever is longer, prior to V1 and during the study period. This also applies to patients who previously participated in clinical studies and were treated with monoclonal antibodies (e.g. mepolizumab, reslizumab, dupilumab, omalizumab). Note that this restriction do not apply to patients, who are confirmed to have only received treatment with placebo.\n 17. Previous receipt of benralizumab.\n 18. Receipt of immunoglobulin or blood products within 30 days prior to V1.\n 19. Receipt of live attenuated vaccines 30 days prior to the date of randomization.\n 20. Receipt of any investigational drug within 30 days or 5 half-lives whichever is longer prior to randomization.\n 21. Receipt of systemic corticosteroid 4 weeks prior to V1, or a scheduled systemic corticosteroid treatment during the study period.NOTE: Sustained release steroids (e.g. Kenalog [Triamcinolone acetonide]) or depot injections require minimum 6 weeks washout prior to V1.\n     \n     \n 22. Receipt of leukotriene antagonist/modifiers for patients who were not on a continuous stable dose for â‰¥30 days prior to V1.\n 23. Concurrent enrolment in another clinical drug interventional trial.\n 24. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level â‰¥ 3 times the upper limit of normal (ULN) confirmed during screening period.\n 25. Previous randomization in the present study.\n 26. Planned major surgical procedures or scheduled NP surgery at the time of the study enrolment and randomization.\n 27. Initiated or is being maintained on an aspirin desensitization regimen for the management of aspirin exacerbated respiratory disease (AERD) at the time of study enrolment or during the run-in period.\n 28. For women only - currently pregnant (or intend to become pregnant), breastfeeding or lactating.",{"$nulls":4},"Actual","2018-01-17","Actual","Anticipated","2020-02-05","Anticipated","2018-07-01","2017-12-13","2018-01-09","2018-07-17","No","Polyps\nNasal polyps\nNasal polyposis\nNose diseases\nRespiratory tract diseases\nOtorhinolaryngologic diseases\nBenralizumab\nMometasone furoate","Interventional","Treatment","Parallel Assignment","Triple (Participant, Care Provider, Investigator)","Randomized","18 Years","75 Years","All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"2017-003675-61","EudraCT Number","Effect of benralizumab on nasal polyp burden|Effect of benralizumab on patient reported nasal blockage (NB)","Change from baseline in endoscopic total nasal polyp score (NPS). NPS (maximum 8) is the sum of the right and left nostril scores|Change from baseline in mean nasal blockage score (NBS). NBS is assessed in daily diary by asking patients to rate the severity of their worst nasal blockage over the past 24 hours using the following response options: 0 - None; 1 - Mild; 2 - Moderate; 3 - Severe","Week 56 (visit 11)","Effect of benralizumab on disease specific health-related quality of life (HRQoL)|Effect of benralizumab on nasal polyp (NP) surgery|Proportion of NP Surgery|Systemic corticosteroids (SCS) use for relief of nasal symptoms|Symptoms associated with nasal polyps|Sinus opacification by computed tomography (CT) scan (subset of patients)|Patient-reported general health status|Other Pre-specified Outcome Measures:|Assessment of the safety of benralizumab|Assessment of the immunogenicity of benralizumab","Change from baseline in SinoNasal Outcome Test (SNOT-22) score. SNOT-22 captures patient-reported physical problems, functional limitations, and emotional consequences of sinonasal condition. It`s patient-reported symptom severity and symptom impact over the past 2 weeks and are captured via a 6-point scale (0- No Problem to 5- Problem as bad as it can be). The total score is the sum of item scores and has a range from 0 to 110|Time to first NP surgery|Proportion of patients with surgery for NP|Proportion of patients with SCS use for NP|Time to first SCS course for NP|Change from baseline in nasal symptom score(s) as captured in the daily diary. Patients report the severity of symptom related to NP at its worst using a 4-point verbal rating scale (0-None to 3-Severe).|Sense of smell captured as change from baseline in University of Pennsylvania Smell Identification Test (UPSIT) score.\n\nIt is a quantitative test of olfactory function which uses microencapsulated odorants that are released by scratching standardized odor-impregnated test booklets. Four booklets each with 10 odorants each are used for the test. Patients are asked to identify the odor using multiple choice format which lists different possibilities. Scores are based on number of correctly identified odors (score range 0 to 40).|Change from baseline in Lund Mackay score|Change from baseline in Short Form 36-item Health survey, Version 2 (SF-36v2)|Total SCS dose used|Number of courses of SCS for NP|Total duration of SCS use for NP|Change from baseline in sinus severity score by Quantitative CT analysis|Other Pre-specified Outcome Measures:|Numbers of adverse events (AEs) and serious adverse events (SAEs)|Presence and absence of benralizumab anti-drug antibodies (ADA)","Week 56 (visit 11)|by Week 56 (visit 11)","information.center@astrazeneca.com","AstraZeneca Clinical Study Information Center","1-877-240-9479","Graz, Austria, 8036 Research SiteInnsbruck, Austria, 6020 Research SiteLinz, Austria, 4010 Research SiteSalzburg, Austria, 5020 Research SiteSt. PÃ¶lten, Austria, 3100 Research SiteWien, Austria, 1090|Brussels, Belgium, 1200 Research SiteGent, Belgium, 9000 Research SiteLeuven, Belgium, 3000|Vancouver, British Columbia, Canada, V5Z 1M9|Hamilton, Ontario, Canada, L8N 3Z5 Research SiteLondon, Ontario, Canada, N6A 4V2 Research SiteMississauga, Ontario, Canada, L5A 3V4 Research SiteOttawa, Ontario, Canada, K1G 6C6|Montreal, Quebec, Canada, H2X 3E4 Research SiteMontreal, Quebec, Canada, H3G 1L5 Research SiteMontreal, Quebec, Canada, H4A 3J1 Research SiteQuebec City, Quebec, Canada, G1V 4W2 Research SiteTrois-RiviÃ¨res, Quebec, Canada, G8T 7A1|Quebec, Canada, G1V 4G5|Arhus C, Denmark, 8000 Research SiteHillerÃ¸d, Denmark, 3400 Research SiteHvidovre, Denmark, 2650 Research SiteKÃ¸benhavn Nv, Denmark, 2400 Research SiteKÃ¸ge, Denmark, 4600 Research SiteNÃ¦stved, Denmark, 4700 Research SiteOdense, Denmark, 5000 Research SiteVejle, Denmark, 7100 Research SiteÃ…lborg, Denmark, 9100|Berlin, Germany, 13353 Research SiteDreieich, Germany, 63303 Research SiteDresden, Germany, 01307 Research SiteDÃ¼sseldorf, Germany, 40225 Research SiteGÃ¶ttingen, Germany, 37073 Research SiteHeidelberg, Germany, 69120 Research SiteLÃ¼beck, Germany, 23538 Research SiteMÃ¼nster, Germany, 48149 Research SiteWiesbaden, Germany, 65183|Budapest, Hungary, 1083 Research SiteBudapest, Hungary, 1106 Research SiteDebrecen, Hungary, 4032 Research SiteEger, Hungary, 3300 Research SiteNyÃ­regyhÃ¡za, Hungary, 4400 Research SitePÃ©cs, Hungary, 7621 Research SiteVeszprÃ©m, Hungary, 8200|Nadarzyn, Poland, 05-830 Research SiteStrzelce Opolskie, Poland, 47-100 Research SiteWarszawa, Poland, 02-547 Research SiteWrocÅ‚aw, Poland, 53-301 Research SiteÅ\u0081Ã³dÅº, Poland, 90-153|Peoria, Arizona, United States, 85381|Fresno, California, United States, 93720 Research SiteLa Mesa, California, United States, 91942 Research SiteLos Angeles, California, United States, 90048 Research SiteLos Angeles, California, United States, 90095-1624 Research SiteOrange, California, United States, 92868 Research SiteRoseville, California, United States, 95661 Research SiteWalnut Creek, California, United States, 94598|Centennial, Colorado, United States, 80112 Research SiteGlenwood Springs, Colorado, United States, 81601 United States, District Of Columbia Research SiteWashington, District Of Columbia, United States, 20037|Boca Raton, Florida, United States, 33487|Decatur, Georgia, United States, 30030|Chicago, Illinois, United States, 60611 Research SiteChicago, Illinois, United States, 60647|West Des Moines, Iowa, United States, 50265|Kansas City, Kansas, United States, 66160|Louisville, Kentucky, United States, 40207|Baltimore, Maryland, United States, 21224|Boston, Massachusetts, United States, 02111|Lincoln, Nebraska, United States, 68505|Bronx, New York, United States, 10461 Research SiteHewlett, New York, United States, 11557 Research SiteNew Windsor, New York, United States, 12553 Research SiteNew York, New York, United States, 10001 Research SiteNew York, New York, United States, 10006 Research SiteNew York, New York, United States, 10011 Research SiteNew York, New York, United States, 10013 Research SiteNew York, New York, United States, 10016 Research SiteNew York, New York, United States, 10016 Research SiteNew York, New York, United States, 10021 Research SiteNew York, New York, United States, 10022 Research SiteNew York, New York, United States, 10028 Research SiteNew York, New York, United States, 10075 Research SiteNew York, New York, United States, 10128 Research SitePlainview, New York, United States, 11803 Research SiteWhite Plains, New York, United States, 10601|Charlotte, North Carolina, United States, 28210 Research SiteConcord, North Carolina, United States, 28025 Research SitePinehurst, North Carolina, United States, 28374 Research SiteWinston-Salem, North Carolina, United States, 27103|Middleburg Heights, Ohio, United States, 44130|Oklahoma City, Oklahoma, United States, 73120|Portland, Oregon, United States, 97239|Bethlehem, Pennsylvania, United States, 18017 Research SitePhiladelphia, Pennsylvania, United States, 19104 Research SitePhiladelphia, Pennsylvania, United States, 19107 Research SitePhiladelphia, Pennsylvania, United States, 19111 Research SitePittsburgh, Pennsylvania, United States, 15213|Charleston, South Carolina, United States, 29425|Conroe, Texas, United States, 77304 Research SiteHouston, Texas, United States, 77030|North Logan, Utah, United States, 84341 Research SiteSaint George, Utah, United States, 84790|Charlottesville, Virginia, United States, 22903 Research SiteNorfolk, Virginia, United States, 23507 Research SiteRichmond, Virginia, United States, 23236-1968|Fairmont, West Virginia, United States, 26554","Arizona|California|Colorado|Florida|Georgia|Illinois|Iowa|Kansas|Kentucky|Maryland|Massachusetts|Nebraska|New York|North Carolina|Ohio|Oklahoma|Oregon|Pennsylvania|South Carolina|Texas|Utah|Virginia|West Virginia","Austria|Belgium|Canada|Denmark|Germany|Hungary|Poland|United States","Research Site|British Columbia Research Site|Ontario Research Site|Quebec Research Site",{"$nulls":4},"2018-07-17","2020-05-25T16:37:17.028","2020-05-26T17:10:42.972","NCT03401229"]
["5ecbf43dfeab101b155308c7","NCT03401229","2018-10-22","AstraZeneca","AZN","Recruiting","Efficacy and Safety Study of Benralizumab for Patients With Severe Nasal Polyposis (OSTRO)","Benralizumab|Mometasone","IL5 Inhibitor|GR Agonist","No",null,"No",null,"Phase 3",2,400,"Anticipated","2018-01-15","2020-11-04",{"$nulls":5},"The aim of this present study is to investigate the use of benralizumab as treatment for severe nasal polyposis. The effect of benralizumab on nasal polyps will be assessed over a 56 weeks of treatment period in patients with severe bilateral nasal polyposis who are still symptomatic despite standard of care therapy, i.e current use of intranasal corticosteroids (INCS) and prior surgery and/or use of systemic corticosteroids. The first 200 patients that complete the 56-week treatment will have a 6 month follow-up (FU) period without dosing.",null,"A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Phase 3 Efficacy and Safety Study Of Benralizumab in Patients With Severe Nasal Polyposis","D3252C00001","Nasal Polyposis","Nasal Polyposis","Nose Diseases","Respiratory","Experimental|Placebo Comparator","Benralizumab 30mg SC + MF|Placebo SC + MF","SC - subcutaneously MF - Mometasone Furoate","Biological","Benralizumab 30 mg SC + Mometasone Furoate|Matching placebo SC + Mometasone Furoate",null,null,"Benralizumab 30mg SC + MF|Placebo SC + MF","\n\n 1.  Capable of giving signed informed consent, which includes compliance with the requirements and restrictions, listed in the informed consent form (ICF) and in protocol.\n 2.  Provision of signed and dated, written informed consent form (ICF) prior to any mandatory study specific procedures, sampling, and analyses and according to international guidelines and/or applicable European Union (EU) guidelines.\n 3.  Provision of signed and dated written genetic informed consent in patients that agree to participate in the genetic sampling, prior to collection of sample for genetic analysis.\n 4.  Female or male patients aged 18 to 75 years inclusive, at the time of signing the ICF.\n 5.  Patients with bilateral sinonasal polyposis that, despite treatment with a stable dose of intranasal corticosteroids (INCS) for at least 4 weeks prior to V1, in addition to history of treatment with systemic (SCS -oral, parenteral) or prior surgery for nasal polyposis (NP), have severity consistent with a need for surgery as described by: * A minimum total Nasal Polyp Score (NPS) of 5 out of a maximum score of 8 (with a unilateral score of at least 2 for each nostril) at V1, and continuously maintained at V2 to meet the randomization criterion, as determined by the study Imaging Core Lab;\n      * Ongoing symptoms for at least 12 weeks prior to V1;\n      * Patient-reported moderate to severe nasal blockage score (NBS) 2 or 3 over the 2-weeks prior to V1 (2-week recall assessment of symptoms, scores 0-none to 3-severe).\n     \n     \n 6.  SNOT-22 total score â‰¥ 30 at enrolment.Patient must meet the following criteria (points 7-10) at the randomization visit:\n     \n     \n 7.  At least 8 days of evaluable daily diary data in the 14-day period prior to randomization (baseline bi-weekly mean score collected from study Day -13 to study Day 0).\n 8.  At randomization, a bi-weekly mean NBS â‰¥ 1.5.\n 9.  SNOT-22 total score â‰¥ 30 at randomization.\n 10. At least 70% compliance with INCS during the run-in period based on daily diary.\n 11. Patients with a minimum weight of 40kg.\n 12. Negative serum pregnancy test result and a negative urine pregnancy test at randomization for female patients of childbearing potential.\n 13. Women of childbearing potential (WOCBP) must use an effective form of birth control as defined in the Clinical Study Protocol (CSP).\n\n15. Male subjects who are sexually active must be surgically sterile at least one year prior to Visit 1 or must use an adequate method of contraception (condom or condom with spermicide depending on local regulations) from the first dose of IP until 16 weeks after their last dose. Men with a partner or partners who is (are) not of childbearing potential are exempt of these requirements\n\n","\n\n 1.  Patients who have undergone any nasal and/or sinus surgery within 3 months prior to V1.\n 2.  Patients with conditions or concomitant disease that makes them non evaluable for the co-primary efficacy endpoint such as: * Unilateral antrochoanal polyps;\n      * Nasal septal deviation that occludes at least one nostril;\n      * Acute sinusitis, nasal infection, or upper respiratory infection at screening or in the 2 weeks before screening;\n      * Current rhinitis medicamentosa;\n      * Allergic fungal rhinosinusitis (AFRS) or Allergic fungal sinusitis (AFS);\n      * Nasal cavity tumors.\n     \n     \n 3.  Clinically important comorbidities that could confound interpretation of clinical efficacy results including, but not limited to: active upper or lower respiratory tract infection, cystic fibrosis, primary ciliary dyskinesia, eosinophilic diseases other than asthma (e.g. allergic bronchopulmonary aspergillosis/mycosis, eosinophilic granulomatosis with polyangitis [Churg-Strauss syndrome], hypereosinophilic syndromes), granulomatosis with polyangitis (Wegener's granulomatosis), Young's syndrome, etc.\n 4.  Any disorder, including but not limited to: cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric, or major physical impairment that is not stable in the opinion of the Investigator or AstraZeneca and could: * Affect the safety of the patient throughout the study;\n      * Influence the findings of the studies or their interpretations;\n      * Impede the patient's ability to complete the entire duration of study.\n     \n     \n 5.  Patients experiencing an asthma exacerbation requiring systemic (oral and/or parenteral) corticosteroids treatment or hospitalization (>24hrs) for treatment of asthma within 4 weeks prior to V1.\n 6.  History of anaphylaxis to any biologic therapy or vaccine.\n 7.  Known history of allergy or reaction to any component of the Investigational Product (IP) formulation.\n 8.  History of Guillain-BarrÃ© syndrome.\n 9.  A helminth parasitic infection diagnosed within 24 weeks prior to V1 and has not been treated with, or has failed to respond to standard of care therapy.\n 10. Current malignancy, or history of malignancy, except for: - Patients who have had basal cell carcinoma, localized squamous cell carcinoma of the skin, or in situ carcinoma of the cervix are eligible provided that patient is in remission and curative therapy was completed at least 12 months prior to V1; - Patients who have had other malignancies are eligible provided that the patient is in remission and curative therapy was completed at least 5 years prior to V1.NOTE: Hormonal therapy is allowed. As long as the cancer is in remission for 5 years, the patient is eligible.\n     \n     \n 11. Any clinically significant cardiac disease or any electrocardiogram (ECG) abnormality obtained during the screening/run-in period, which may put the patient at risk or interfere with study assessments.\n 12. Positive hepatitis B surface antigen, or hepatitis C virus antibody serology (confirmed by additional testing, e.g. hepatitis C RNA test, if indicated), or a positive medical history for hepatitis B or C (Note: Patients with history of hepatitis B vaccination without history of hepatitis B are allowed to enroll).\n 13. History of known immunodeficiency disorder, including a positive human immunodeficiency virus (HIV) test.\n 14. Infection requiring systemic antibiotics (Ab) within 14 days prior to V1\n 15. Use of immunosuppressive medication (including but not limited to: methotrexate, troleandomycin, cyclosporine, azathioprine, or any experimental anti-inflammatory therapy) within 3 months prior to V1.\n 16. Receipt of any marketed or investigational biologic products (monoclonal or polyclonal antibody) within 6 months or 5 half-lives prior to the date informed consent, is obtained, whichever is longer, prior to V1 and during the study period. This also applies to patients who previously participated in clinical studies and were treated with monoclonal antibodies (e.g. mepolizumab, reslizumab, dupilumab, omalizumab). Note that this restriction do not apply to patients, who are confirmed to have only received treatment with placebo.\n 17. Previous receipt of benralizumab.\n 18. Receipt of immunoglobulin or blood products within 30 days prior to V1.\n 19. Receipt of live attenuated vaccines 30 days prior to the date of randomization.\n 20. Receipt of any investigational drug within 30 days or 5 half-lives whichever is longer prior to randomization.\n 21. Receipt of systemic corticosteroid 4 weeks prior to V1, or a scheduled systemic corticosteroid treatment during the study period.NOTE: Sustained release steroids (e.g. Kenalog [Triamcinolone acetonide]) or depot injections require minimum 6 weeks washout prior to V1.\n     \n     \n 22. Receipt of leukotriene antagonist/modifiers for patients who were not on a continuous stable dose for â‰¥30 days prior to V1.\n 23. Concurrent enrolment in another clinical drug interventional trial.\n 24. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level â‰¥ 3 times the upper limit of normal (ULN) confirmed during screening period.\n 25. Previous randomization in the present study.\n 26. Planned major surgical procedures or scheduled NP surgery at the time of the study enrolment and randomization.\n 27. Initiated or is being maintained on an aspirin desensitization regimen for the management of aspirin exacerbated respiratory disease (AERD) at the time of study enrolment or during the run-in period.\n 28. For women only - currently pregnant (or intend to become pregnant), breastfeeding or lactating.",{"$nulls":4},"Actual","2018-01-17","Actual","Anticipated","2020-11-04","Anticipated","2018-10-01","2017-12-13","2018-01-09","2018-10-19","No","Polyps\nNasal polyps\nNasal polyposis\nNose diseases\nRespiratory tract diseases\nOtorhinolaryngologic diseases\nBenralizumab\nMometasone furoate","Interventional","Treatment","Parallel Assignment","Triple (Participant, Care Provider, Investigator)","Randomized","18 Years","75 Years","All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"2017-003675-61","EudraCT Number","Effect of benralizumab on nasal polyp burden|Effect of benralizumab on patient reported nasal blockage (NB)","Change from baseline in endoscopic total nasal polyp score (NPS). NPS (maximum 8) is the sum of the right and left nostril scores|Change from baseline in mean nasal blockage score (NBS). NBS is assessed in daily diary by asking patients to rate the severity of their worst nasal blockage over the past 24 hours using the following response options: 0 - None; 1 - Mild; 2 - Moderate; 3 - Severe","Week 56 (visit 11)","Effect of benralizumab on disease specific health-related quality of life (HRQoL)|Effect of benralizumab on nasal polyp (NP) surgery|Proportion of NP Surgery|Systemic corticosteroids (SCS) use for relief of nasal symptoms|Symptoms associated with nasal polyps|Sinus opacification by computed tomography (CT) scan (subset of patients)|Patient-reported general health status|Other Pre-specified Outcome Measures:|Assessment of the safety of benralizumab|Assessment of the immunogenicity of benralizumab","Change from baseline in SinoNasal Outcome Test (SNOT-22) score. SNOT-22 captures patient-reported physical problems, functional limitations, and emotional consequences of sinonasal condition. It`s patient-reported symptom severity and symptom impact over the past 2 weeks and are captured via a 6-point scale (0- No Problem to 5- Problem as bad as it can be). The total score is the sum of item scores and has a range from 0 to 110|Time to first NP surgery|Proportion of patients with surgery for NP|Proportion of patients with SCS use for NP|Time to first SCS course for NP|Change from baseline in nasal symptom score(s) as captured in the daily diary. Patients report the severity of symptom related to NP at its worst using a 4-point verbal rating scale (0-None to 3-Severe).|Sense of smell captured as change from baseline in University of Pennsylvania Smell Identification Test (UPSIT) score.\n\nIt is a quantitative test of olfactory function which uses microencapsulated odorants that are released by scratching standardized odor-impregnated test booklets. Four booklets each with 10 odorants each are used for the test. Patients are asked to identify the odor using multiple choice format which lists different possibilities. Scores are based on number of correctly identified odors (score range 0 to 40).|Change from baseline in Lund Mackay score|Change from baseline in Short Form 36-item Health survey, Version 2 (SF-36v2)|Total SCS dose used|Number of courses of SCS for NP|Total duration of SCS use for NP|Change from baseline in sinus severity score by Quantitative CT analysis|Other Pre-specified Outcome Measures:|Numbers of adverse events (AEs) and serious adverse events (SAEs)|Presence and absence of benralizumab anti-drug antibodies (ADA)","Week 56 (visit 11)|by Week 56 (visit 11)","information.center@astrazeneca.com","AstraZeneca Clinical Study Information Center","1-877-240-9479","Graz, Austria, 8036 Research SiteInnsbruck, Austria, 6020 Research SiteLinz, Austria, 4010 Research SiteSalzburg, Austria, 5020 Research SiteSt. PÃ¶lten, Austria, 3100 Research SiteWien, Austria, 1090|Brussels, Belgium, 1200 Research SiteGent, Belgium, 9000 Research SiteLeuven, Belgium, 3000|Vancouver, British Columbia, Canada, V5Z 1M9|Hamilton, Ontario, Canada, L8N 3Z5 Research SiteLondon, Ontario, Canada, N6A 4V2 Research SiteMississauga, Ontario, Canada, L5A 3V4 Research SiteOttawa, Ontario, Canada, K1G 6C6|Montreal, Quebec, Canada, H2X 3E4 Research SiteMontreal, Quebec, Canada, H3G 1L5 Research SiteMontreal, Quebec, Canada, H4A 3J1 Research SiteQuebec City, Quebec, Canada, G1V 4W2 Research SiteTrois-RiviÃ¨res, Quebec, Canada, G8T 7A1|Quebec, Canada, G1V 4G5|Arhus C, Denmark, 8000 Research SiteHillerÃ¸d, Denmark, 3400 Research SiteHvidovre, Denmark, 2650 Research SiteKÃ¸benhavn Nv, Denmark, 2400 Research SiteKÃ¸ge, Denmark, 4600 Research SiteNÃ¦stved, Denmark, 4700 Research SiteOdense, Denmark, 5000 Research SiteVejle, Denmark, 7100 Research SiteÃ…lborg, Denmark, 9100|Aschaffenburg, Germany, 63739 Research SiteBerlin, Germany, 13353 Research SiteDreieich, Germany, 63303 Research SiteDresden, Germany, 01307 Research SiteDÃ¼sseldorf, Germany, 40225 Research SiteGÃ¶ttingen, Germany, 37073 Research SiteHeidelberg, Germany, 69120 Research SiteLÃ¼beck, Germany, 23538 Research SiteMÃ¼nster, Germany, 48149 Research SiteWiesbaden, Germany, 65183|Budapest, Hungary, 1083 Research SiteBudapest, Hungary, 1106 Research SiteDebrecen, Hungary, 4032 Research SiteEger, Hungary, 3300 Research SiteNyÃ­regyhÃ¡za, Hungary, 4400 Research SitePÃ©cs, Hungary, 7621 Research SiteVeszprÃ©m, Hungary, 8200|Nadarzyn, Poland, 05-830 Research SiteStrzelce Opolskie, Poland, 47-100 Research SiteWarszawa, Poland, 02-547 Research SiteWrocÅ‚aw, Poland, 50-220 Research SiteWrocÅ‚aw, Poland, 53-301 Research SiteÅ\u0081Ã³dÅº, Poland, 90-153|Peoria, Arizona, United States, 85381|Fresno, California, United States, 93720 Research SiteHuntington Beach, California, United States, 92647 Research SiteLa Mesa, California, United States, 91942 Research SiteLos Angeles, California, United States, 90048 Research SiteLos Angeles, California, United States, 90095-1624 Research SiteOrange, California, United States, 92868 Research SiteRoseville, California, United States, 95661 Research SiteWalnut Creek, California, United States, 94598|Centennial, Colorado, United States, 80112 Research SiteGlenwood Springs, Colorado, United States, 81601 United States, District Of Columbia Research SiteWashington, District Of Columbia, United States, 20037|Boca Raton, Florida, United States, 33487|Atlanta, Georgia, United States, 30308 Research SiteDecatur, Georgia, United States, 30030|Chicago, Illinois, United States, 60611 Research SiteChicago, Illinois, United States, 60647 Research SiteChicago, Illinois, United States, 60657|Des Moines, Iowa, United States, 50312 Research SiteWest Des Moines, Iowa, United States, 50265|Kansas City, Kansas, United States, 66160|Louisville, Kentucky, United States, 40207|Baltimore, Maryland, United States, 21224|Boston, Massachusetts, United States, 02111 Research SiteBoston, Massachusetts, United States, 02114|Lincoln, Nebraska, United States, 68505|Bronx, New York, United States, 10461 Research SiteBronx, New York, United States, 10461 Research SiteHewlett, New York, United States, 11557 Research SiteNew Hyde Park, New York, United States, 11040 Research SiteNew Windsor, New York, United States, 12553 Research SiteNew York, New York, United States, 10001 Research SiteNew York, New York, United States, 10006 Research SiteNew York, New York, United States, 10011 Research SiteNew York, New York, United States, 10013 Research SiteNew York, New York, United States, 10016 Research SiteNew York, New York, United States, 10016 Research SiteNew York, New York, United States, 10021 Research SiteNew York, New York, United States, 10022 Research SiteNew York, New York, United States, 10028 Research SiteNew York, New York, United States, 10028 Research SiteNew York, New York, United States, 10075 Research SiteNew York, New York, United States, 10128 Research SitePlainview, New York, United States, 11803 Research SiteWhite Plains, New York, United States, 10601|Charlotte, North Carolina, United States, 28210 Research SiteConcord, North Carolina, United States, 28025 Research SiteFayetteville, North Carolina, United States, 28304 Research SitePinehurst, North Carolina, United States, 28374 Research SiteWinston-Salem, North Carolina, United States, 27103|Middleburg Heights, Ohio, United States, 44130|Oklahoma City, Oklahoma, United States, 73120|Portland, Oregon, United States, 97239|Bethlehem, Pennsylvania, United States, 18017 Research SitePhiladelphia, Pennsylvania, United States, 19104 Research SitePhiladelphia, Pennsylvania, United States, 19107 Research SitePhiladelphia, Pennsylvania, United States, 19111 Research SitePittsburgh, Pennsylvania, United States, 15213|Charleston, South Carolina, United States, 29425 Research SiteOrangeburg, South Carolina, United States, 29118|Boerne, Texas, United States, 78006 Research SiteConroe, Texas, United States, 77304 Research SiteHouston, Texas, United States, 77030|North Logan, Utah, United States, 84341 Research SiteSaint George, Utah, United States, 84790|Charlottesville, Virginia, United States, 22903 Research SiteNorfolk, Virginia, United States, 23507 Research SiteRichmond, Virginia, United States, 23236-1968|Spokane Valley, Washington, United States, 99216|Fairmont, West Virginia, United States, 26554","Arizona|California|Colorado|Florida|Georgia|Illinois|Iowa|Kansas|Kentucky|Maryland|Massachusetts|Nebraska|New York|North Carolina|Ohio|Oklahoma|Oregon|Pennsylvania|South Carolina|Texas|Utah|Virginia|Washington|West Virginia","Austria|Belgium|Canada|Denmark|Germany|Hungary|Poland|United States","Research Site|British Columbia Research Site|Ontario Research Site|Quebec Research Site",{"$nulls":4},"2018-10-19","2020-05-25T16:37:17.029","2020-05-26T17:10:42.972","NCT03401229"]
["5ecbf43d11702c1b1b916aa6","NCT03401229","2019-02-07","AstraZeneca","AZN","Recruiting","Efficacy and Safety Study of Benralizumab for Patients With Severe Nasal Polyposis (OSTRO)","Benralizumab|Mometasone","IL5 Inhibitor|GR Agonist","No",null,"No",null,"Phase 3",2,400,"Anticipated","2018-01-15","2020-11-04",{"$nulls":5},"The aim of this present study is to investigate the use of benralizumab as treatment for severe nasal polyposis. The effect of benralizumab on nasal polyps will be assessed over a 56 weeks of treatment period in patients with severe bilateral nasal polyposis who are still symptomatic despite standard of care therapy, i.e current use of intranasal corticosteroids (INCS) and prior surgery and/or use of systemic corticosteroids. The first 200 patients that complete the 56-week treatment will have a 6 month follow-up (FU) period without dosing.",null,"A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Phase 3 Efficacy and Safety Study Of Benralizumab in Patients With Severe Nasal Polyposis","D3252C00001","Nasal Polyposis","Nasal Polyposis","Nose Diseases","Respiratory","Experimental|Placebo Comparator","Benralizumab 30mg SC + MF|Placebo SC + MF","SC - subcutaneously MF - Mometasone Furoate","Biological","Benralizumab 30 mg SC + Mometasone Furoate|Matching placebo SC + Mometasone Furoate",null,null,"Benralizumab 30mg SC + MF|Placebo SC + MF","\n\n 1.  Capable of giving signed informed consent, which includes compliance with the requirements and restrictions, listed in the informed consent form (ICF) and in protocol.\n 2.  Provision of signed and dated, written informed consent form (ICF) prior to any mandatory study specific procedures, sampling, and analyses and according to international guidelines and/or applicable European Union (EU) guidelines.\n 3.  Provision of signed and dated written genetic informed consent in patients that agree to participate in the genetic sampling, prior to collection of sample for genetic analysis.\n 4.  Female or male patients aged 18 to 75 years inclusive, at the time of signing the ICF.\n 5.  Patients with bilateral sinonasal polyposis that, despite treatment with a stable dose of intranasal corticosteroids (INCS) for at least 4 weeks prior to V1, in addition to history of treatment with systemic (SCS -oral, parenteral) or prior surgery for nasal polyposis (NP), have severity consistent with a need for surgery as described by: * A minimum total Nasal Polyp Score (NPS) of 5 out of a maximum score of 8 (with a unilateral score of at least 2 for each nostril) at V1, and continuously maintained at V2 to meet the randomization criterion, as determined by the study Imaging Core Lab;\n      * Ongoing symptoms for at least 12 weeks prior to V1;\n      * Patient-reported moderate to severe nasal blockage score (NBS) 2 or 3 over the 2-weeks prior to V1 (2-week recall assessment of symptoms, scores 0-none to 3-severe).\n     \n     \n 6.  SNOT-22 total score â‰¥ 30 at enrolment.Patient must meet the following criteria (points 7-10) at the randomization visit:\n     \n     \n 7.  At least 8 days of evaluable daily diary data in the 14-day period prior to randomization (baseline bi-weekly mean score collected from study Day -13 to study Day 0).\n 8.  At randomization, a bi-weekly mean NBS â‰¥ 1.5.\n 9.  SNOT-22 total score â‰¥ 30 at randomization.\n 10. At least 70% compliance with INCS during the run-in period based on daily diary.\n 11. Patients with a minimum weight of 40kg.\n 12. Negative serum pregnancy test result and a negative urine pregnancy test at randomization for female patients of childbearing potential.\n 13. Women of childbearing potential (WOCBP) must use an effective form of birth control as defined in the Clinical Study Protocol (CSP).\n\n15. Male subjects who are sexually active must be surgically sterile at least one year prior to Visit 1 or must use an adequate method of contraception (condom or condom with spermicide depending on local regulations) from the first dose of IP until 16 weeks after their last dose. Men with a partner or partners who is (are) not of childbearing potential are exempt of these requirements\n\n","\n\n 1.  Patients who have undergone any nasal and/or sinus surgery within 3 months prior to V1.\n 2.  Patients with conditions or concomitant disease that makes them non evaluable for the co-primary efficacy endpoint such as: * Unilateral antrochoanal polyps;\n      * Nasal septal deviation that occludes at least one nostril;\n      * Acute sinusitis, nasal infection, or upper respiratory infection at screening or in the 2 weeks before screening;\n      * Current rhinitis medicamentosa;\n      * Allergic fungal rhinosinusitis (AFRS) or Allergic fungal sinusitis (AFS);\n      * Nasal cavity tumors.\n     \n     \n 3.  Clinically important comorbidities that could confound interpretation of clinical efficacy results including, but not limited to: active upper or lower respiratory tract infection, cystic fibrosis, primary ciliary dyskinesia, eosinophilic diseases other than asthma (e.g. allergic bronchopulmonary aspergillosis/mycosis, eosinophilic granulomatosis with polyangitis [Churg-Strauss syndrome], hypereosinophilic syndromes), granulomatosis with polyangitis (Wegener's granulomatosis), Young's syndrome, etc.\n 4.  Any disorder, including but not limited to: cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric, or major physical impairment that is not stable in the opinion of the Investigator or AstraZeneca and could: * Affect the safety of the patient throughout the study;\n      * Influence the findings of the studies or their interpretations;\n      * Impede the patient's ability to complete the entire duration of study.\n     \n     \n 5.  Patients experiencing an asthma exacerbation requiring systemic (oral and/or parenteral) corticosteroids treatment or hospitalization (>24hrs) for treatment of asthma within 4 weeks prior to V1.\n 6.  History of anaphylaxis to any biologic therapy or vaccine.\n 7.  Known history of allergy or reaction to any component of the Investigational Product (IP) formulation.\n 8.  History of Guillain-BarrÃ© syndrome.\n 9.  A helminth parasitic infection diagnosed within 24 weeks prior to V1 and has not been treated with, or has failed to respond to standard of care therapy.\n 10. Current malignancy, or history of malignancy, except for: - Patients who have had basal cell carcinoma, localized squamous cell carcinoma of the skin, or in situ carcinoma of the cervix are eligible provided that patient is in remission and curative therapy was completed at least 12 months prior to V1; - Patients who have had other malignancies are eligible provided that the patient is in remission and curative therapy was completed at least 5 years prior to V1.NOTE: Hormonal therapy is allowed. As long as the cancer is in remission for 5 years, the patient is eligible.\n     \n     \n 11. Any clinically significant cardiac disease or any electrocardiogram (ECG) abnormality obtained during the screening/run-in period, which may put the patient at risk or interfere with study assessments.\n 12. Positive hepatitis B surface antigen, or hepatitis C virus antibody serology (confirmed by additional testing, e.g. hepatitis C RNA test, if indicated), or a positive medical history for hepatitis B or C (Note: Patients with history of hepatitis B vaccination without history of hepatitis B are allowed to enroll).\n 13. History of known immunodeficiency disorder, including a positive human immunodeficiency virus (HIV) test.\n 14. Infection requiring systemic antibiotics (Ab) within 14 days prior to V1\n 15. Use of immunosuppressive medication (including but not limited to: methotrexate, troleandomycin, cyclosporine, azathioprine, or any experimental anti-inflammatory therapy) within 3 months prior to V1.\n 16. Receipt of any marketed or investigational biologic products (monoclonal or polyclonal antibody) within 6 months or 5 half-lives prior to the date informed consent, is obtained, whichever is longer, prior to V1 and during the study period. This also applies to patients who previously participated in clinical studies and were treated with monoclonal antibodies (e.g. mepolizumab, reslizumab, dupilumab, omalizumab). Note that this restriction do not apply to patients, who are confirmed to have only received treatment with placebo.\n 17. Previous receipt of benralizumab.\n 18. Receipt of immunoglobulin or blood products within 30 days prior to V1.\n 19. Receipt of live attenuated vaccines 30 days prior to the date of randomization.\n 20. Receipt of any investigational drug within 30 days or 5 half-lives whichever is longer prior to randomization.\n 21. Receipt of systemic corticosteroid 4 weeks prior to V1, or a scheduled systemic corticosteroid treatment during the study period.NOTE: Sustained release steroids (e.g. Kenalog [Triamcinolone acetonide]) or depot injections require minimum 6 weeks washout prior to V1.\n     \n     \n 22. Receipt of leukotriene antagonist/modifiers for patients who were not on a continuous stable dose for â‰¥30 days prior to V1.\n 23. Concurrent enrolment in another clinical drug interventional trial.\n 24. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level â‰¥ 3 times the upper limit of normal (ULN) confirmed during screening period.\n 25. Previous randomization in the present study.\n 26. Planned major surgical procedures or scheduled NP surgery at the time of the study enrolment and randomization.\n 27. Initiated or is being maintained on an aspirin desensitization regimen for the management of aspirin exacerbated respiratory disease (AERD) at the time of study enrolment or during the run-in period.\n 28. For women only - currently pregnant (or intend to become pregnant), breastfeeding or lactating.",{"$nulls":4},"Actual","2018-01-17","Actual","Anticipated","2020-11-04","Anticipated","2019-02-01","2017-12-13","2018-01-09","2019-02-06","No","Polyps\nNasal polyps\nNasal polyposis\nNose diseases\nRespiratory tract diseases\nOtorhinolaryngologic diseases\nBenralizumab\nMometasone furoate","Interventional","Treatment","Parallel Assignment","Triple (Participant, Care Provider, Investigator)","Randomized","18 Years","75 Years","All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"2017-003675-61","EudraCT Number","Effect of benralizumab on nasal polyp burden|Effect of benralizumab on patient reported nasal blockage (NB)","Change from baseline in endoscopic total nasal polyp score (NPS). NPS (maximum 8) is the sum of the right and left nostril scores|Change from baseline in mean nasal blockage score (NBS). NBS is assessed in daily diary by asking patients to rate the severity of their worst nasal blockage over the past 24 hours using the following response options: 0 - None; 1 - Mild; 2 - Moderate; 3 - Severe","Week 56 (visit 11)","Effect of benralizumab on disease specific health-related quality of life (HRQoL)|Effect of benralizumab on nasal polyp (NP) surgery|Proportion of NP Surgery|Systemic corticosteroids (SCS) use for relief of nasal symptoms|Symptoms associated with nasal polyps|Sinus opacification by computed tomography (CT) scan (subset of patients)|Patient-reported general health status|Other Pre-specified Outcome Measures:|Assessment of the safety of benralizumab|Assessment of the immunogenicity of benralizumab","Change from baseline in SinoNasal Outcome Test (SNOT-22) score. SNOT-22 captures patient-reported physical problems, functional limitations, and emotional consequences of sinonasal condition. It`s patient-reported symptom severity and symptom impact over the past 2 weeks and are captured via a 6-point scale (0- No Problem to 5- Problem as bad as it can be). The total score is the sum of item scores and has a range from 0 to 110|Time to first NP surgery|Proportion of patients with surgery for NP|Proportion of patients with SCS use for NP|Time to first SCS course for NP|Change from baseline in nasal symptom score(s) as captured in the daily diary. Patients report the severity of symptom related to NP at its worst using a 4-point verbal rating scale (0-None to 3-Severe).|Sense of smell captured as change from baseline in University of Pennsylvania Smell Identification Test (UPSIT) score.\n\nIt is a quantitative test of olfactory function which uses microencapsulated odorants that are released by scratching standardized odor-impregnated test booklets. Four booklets each with 10 odorants each are used for the test. Patients are asked to identify the odor using multiple choice format which lists different possibilities. Scores are based on number of correctly identified odors (score range 0 to 40).|Change from baseline in Lund Mackay score|Change from baseline in Short Form 36-item Health survey, Version 2 (SF-36v2)|Total SCS dose used|Number of courses of SCS for NP|Total duration of SCS use for NP|Change from baseline in sinus severity score by Quantitative CT analysis|Other Pre-specified Outcome Measures:|Numbers of adverse events (AEs) and serious adverse events (SAEs)|Presence and absence of benralizumab anti-drug antibodies (ADA)","Week 56 (visit 11)|by Week 56 (visit 11)","information.center@astrazeneca.com","AstraZeneca Clinical Study Information Center","1-877-240-9479","Graz, Austria, 8036 Research SiteInnsbruck, Austria, 6020 Research SiteLinz, Austria, 4010 Research SiteSalzburg, Austria, 5020 Research SiteSt. PÃ¶lten, Austria, 3100 Research SiteWien, Austria, 1090|Brussels, Belgium, 1200 Research SiteGent, Belgium, 9000 Research SiteLeuven, Belgium, 3000|Vancouver, British Columbia, Canada, V5Z 1M9|Hamilton, Ontario, Canada, L8N 3Z5 Research SiteHamilton, Ontario, Canada, L8S 1G5 Research SiteLondon, Ontario, Canada, N6A 4V2 Research SiteMississauga, Ontario, Canada, L5A 3V4 Research SiteOttawa, Ontario, Canada, K1G 6C6|Montreal, Quebec, Canada, H2X 3E4 Research SiteMontreal, Quebec, Canada, H3G 1L5 Research SiteMontreal, Quebec, Canada, H4A 3J1 Research SiteQuebec City, Quebec, Canada, G1V 4W2 Research SiteTrois-RiviÃ¨res, Quebec, Canada, G8T 7A1|Quebec, Canada, G1V 4G5|Arhus C, Denmark, 8000 Research SiteHillerÃ¸d, Denmark, 3400 Research SiteHvidovre, Denmark, 2650 Research SiteKÃ¸benhavn Nv, Denmark, 2400 Research SiteKÃ¸ge, Denmark, 4600 Research SiteNÃ¦stved, Denmark, 4700 Research SiteOdense, Denmark, 5000 Research SiteVejle, Denmark, 7100 Research SiteÃ…lborg, Denmark, 9000|Aschaffenburg, Germany, 63739 Research SiteBerlin, Germany, 13353 Research SiteDreieich, Germany, 63303 Research SiteDresden, Germany, 01307 Research SiteDÃ¼sseldorf, Germany, 40225 Research SiteGÃ¶ttingen, Germany, 37073 Research SiteHeidelberg, Germany, 69120 Research SiteLÃ¼beck, Germany, 23538 Research SiteMÃ¼nster, Germany, 48149 Research SiteWiesbaden, Germany, 65183|Budapest, Hungary, 1083 Research SiteBudapest, Hungary, 1106 Research SiteDebrecen, Hungary, 4032 Research SiteEger, Hungary, 3300 Research SiteNyÃ­regyhÃ¡za, Hungary, 4400 Research SitePÃ©cs, Hungary, 7621 Research SiteVeszprÃ©m, Hungary, 8200|Nadarzyn, Poland, 05-830 Research SiteStrzelce Opolskie, Poland, 47-100 Research SiteWarszawa, Poland, 02-547 Research SiteWrocÅ‚aw, Poland, 50-220 Research SiteWrocÅ‚aw, Poland, 53-301 Research SiteÅ\u0081Ã³dÅº, Poland, 90-153|Birmingham, Alabama, United States, 35209|Peoria, Arizona, United States, 85381|Fresno, California, United States, 93720 Research SiteHuntington Beach, California, United States, 92647 Research SiteLa Mesa, California, United States, 91942 Research SiteLos Angeles, California, United States, 90048 Research SiteLos Angeles, California, United States, 90095-1624 Research SiteLos Angeles, California, United States, 90095 Research SiteOrange, California, United States, 92868 Research SiteRoseville, California, United States, 95661 Research SiteWalnut Creek, California, United States, 94598|Centennial, Colorado, United States, 80112 Research SiteGlenwood Springs, Colorado, United States, 81601 United States, District Of Columbia Research SiteWashington, District Of Columbia, United States, 20037|Boca Raton, Florida, United States, 33487 Research SiteLake Mary, Florida, United States, 32746|Atlanta, Georgia, United States, 30308 Research SiteDecatur, Georgia, United States, 30030|Chicago, Illinois, United States, 60611 Research SiteChicago, Illinois, United States, 60647 Research SiteChicago, Illinois, United States, 60657|Des Moines, Iowa, United States, 50312 Research SiteWest Des Moines, Iowa, United States, 50265|Kansas City, Kansas, United States, 66160|Louisville, Kentucky, United States, 40207|Baltimore, Maryland, United States, 21224|Boston, Massachusetts, United States, 02111 Research SiteBoston, Massachusetts, United States, 02114|Rochester, Minnesota, United States, 55905|Lincoln, Nebraska, United States, 68505|Bronx, New York, United States, 10461 Research SiteHewlett, New York, United States, 11557 Research SiteNew Hyde Park, New York, United States, 11040 Research SiteNew Windsor, New York, United States, 12553 Research SiteNew York, New York, United States, 10001 Research SiteNew York, New York, United States, 10006 Research SiteNew York, New York, United States, 10011 Research SiteNew York, New York, United States, 10013 Research SiteNew York, New York, United States, 10016 Research SiteNew York, New York, United States, 10016 Research SiteNew York, New York, United States, 10021 Research SiteNew York, New York, United States, 10022 Research SiteNew York, New York, United States, 10028 Research SiteNew York, New York, United States, 10028 Research SiteNew York, New York, United States, 10075 Research SiteNew York, New York, United States, 10128 Research SitePlainview, New York, United States, 11803 Research SiteWhite Plains, New York, United States, 10605|Charlotte, North Carolina, United States, 28210 Research SiteConcord, North Carolina, United States, 28025 Research SitePinehurst, North Carolina, United States, 28374 Research SiteWinston-Salem, North Carolina, United States, 27103|Middleburg Heights, Ohio, United States, 44130|Oklahoma City, Oklahoma, United States, 73120|Medford, Oregon, United States, 97504 Research SitePortland, Oregon, United States, 97239|Bethlehem, Pennsylvania, United States, 18017 Research SitePhiladelphia, Pennsylvania, United States, 19104 Research SitePhiladelphia, Pennsylvania, United States, 19107 Research SitePhiladelphia, Pennsylvania, United States, 19111 Research SitePittsburgh, Pennsylvania, United States, 15213|Charleston, South Carolina, United States, 29425 Research SiteOrangeburg, South Carolina, United States, 29118|Boerne, Texas, United States, 78006 Research SiteConroe, Texas, United States, 77304 Research SiteHouston, Texas, United States, 77030|North Logan, Utah, United States, 84341 Research SiteSaint George, Utah, United States, 84790|Charlottesville, Virginia, United States, 22903 Research SiteNorfolk, Virginia, United States, 23507 Research SiteRichmond, Virginia, United States, 23236-1968|Spokane Valley, Washington, United States, 99216|Fairmont, West Virginia, United States, 26554","Alabama|Arizona|California|Colorado|Florida|Georgia|Illinois|Iowa|Kansas|Kentucky|Maryland|Massachusetts|Minnesota|Nebraska|New York|North Carolina|Ohio|Oklahoma|Oregon|Pennsylvania|South Carolina|Texas|Utah|Virginia|Washington|West Virginia","Austria|Belgium|Canada|Denmark|Germany|Hungary|Poland|United States","Research Site|British Columbia Research Site|Ontario Research Site|Quebec Research Site",{"$nulls":4},"2019-02-06","2020-05-25T16:37:17.318","2020-05-26T17:10:42.972","NCT03401229"]
["5ecbf43d307e3d1b1f8d9d28","NCT03401229","2019-04-24","AstraZeneca","AZN","Recruiting","Efficacy and Safety Study of Benralizumab for Patients With Severe Nasal Polyposis (OSTRO)","Benralizumab|Mometasone","IL5 Inhibitor|GR Agonist","No",null,"No",null,"Phase 3",2,400,"Anticipated","2018-01-15","2020-09-04",{"$nulls":5},"The aim of this present study is to investigate the use of benralizumab as treatment for severe nasal polyposis. The effect of benralizumab on nasal polyps will be assessed over a 56 weeks of treatment period in patients with severe bilateral nasal polyposis who are still symptomatic despite standard of care therapy, i.e current use of intranasal corticosteroids (INCS) and prior surgery and/or use of systemic corticosteroids. The first 200 patients that complete the 56-week treatment will have a 6 month follow-up (FU) period without dosing.",null,"A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Phase 3 Efficacy and Safety Study Of Benralizumab in Patients With Severe Nasal Polyposis","D3252C00001","Nasal Polyposis","Nasal Polyposis","Nose Diseases","Respiratory","Experimental|Placebo Comparator","Benralizumab 30mg SC + MF|Placebo SC + MF","SC - subcutaneously MF - Mometasone Furoate","Biological","Benralizumab 30 mg SC + Mometasone Furoate|Matching placebo SC + Mometasone Furoate",null,null,"Benralizumab 30mg SC + MF|Placebo SC + MF","\n\n 1.  Capable of giving signed informed consent, which includes compliance with the requirements and restrictions, listed in the informed consent form (ICF) and in protocol.\n 2.  Provision of signed and dated, written informed consent form (ICF) prior to any mandatory study specific procedures, sampling, and analyses and according to international guidelines and/or applicable European Union (EU) guidelines.\n 3.  Provision of signed and dated written genetic informed consent in patients that agree to participate in the genetic sampling, prior to collection of sample for genetic analysis.\n 4.  Female or male patients aged 18 to 75 years inclusive, at the time of signing the ICF.\n 5.  Patients with bilateral sinonasal polyposis that, despite treatment with a stable dose of intranasal corticosteroids (INCS) for at least 4 weeks prior to V1, in addition to history of treatment with systemic (SCS -oral, parenteral) or prior surgery for nasal polyposis (NP), have severity consistent with a need for surgery as described by: * A minimum total Nasal Polyp Score (NPS) of 5 out of a maximum score of 8 (with a unilateral score of at least 2 for each nostril) at V1, and continuously maintained at V2 to meet the randomization criterion, as determined by the study Imaging Core Lab;\n      * Ongoing symptoms for at least 12 weeks prior to V1;\n      * Patient-reported moderate to severe nasal blockage score (NBS) 2 or 3 over the 2-weeks prior to V1 (2-week recall assessment of symptoms, scores 0-none to 3-severe).\n     \n     \n 6.  SNOT-22 total score â‰¥ 30 at enrolment.Patient must meet the following criteria (points 7-10) at the randomization visit:\n     \n     \n 7.  At least 8 days of evaluable daily diary data in the 14-day period prior to randomization (baseline bi-weekly mean score collected from study Day -13 to study Day 0).\n 8.  At randomization, a bi-weekly mean NBS â‰¥ 1.5.\n 9.  SNOT-22 total score â‰¥ 30 at randomization.\n 10. At least 70% compliance with INCS during the run-in period based on daily diary.\n 11. Patients with a minimum weight of 40kg.\n 12. Negative serum pregnancy test result and a negative urine pregnancy test at randomization for female patients of childbearing potential.\n 13. Women of childbearing potential (WOCBP) must use an effective form of birth control as defined in the Clinical Study Protocol (CSP).\n\n15. Male subjects who are sexually active must be surgically sterile at least one year prior to Visit 1 or must use an adequate method of contraception (condom or condom with spermicide depending on local regulations) from the first dose of IP until 16 weeks after their last dose. Men with a partner or partners who is (are) not of childbearing potential are exempt of these requirements\n\n","\n\n 1.  Patients who have undergone any nasal and/or sinus surgery within 3 months prior to V1.\n 2.  Patients with conditions or concomitant disease that makes them non evaluable for the co-primary efficacy endpoint such as: * Unilateral antrochoanal polyps;\n      * Nasal septal deviation that occludes at least one nostril;\n      * Acute sinusitis, nasal infection, or upper respiratory infection at screening or in the 2 weeks before screening;\n      * Current rhinitis medicamentosa;\n      * Allergic fungal rhinosinusitis (AFRS) or Allergic fungal sinusitis (AFS);\n      * Nasal cavity tumors.\n     \n     \n 3.  Clinically important comorbidities that could confound interpretation of clinical efficacy results including, but not limited to: active upper or lower respiratory tract infection, cystic fibrosis, primary ciliary dyskinesia, eosinophilic diseases other than asthma (e.g. allergic bronchopulmonary aspergillosis/mycosis, eosinophilic granulomatosis with polyangitis [Churg-Strauss syndrome], hypereosinophilic syndromes), granulomatosis with polyangitis (Wegener's granulomatosis), Young's syndrome, etc.\n 4.  Any disorder, including but not limited to: cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric, or major physical impairment that is not stable in the opinion of the Investigator or AstraZeneca and could: * Affect the safety of the patient throughout the study;\n      * Influence the findings of the studies or their interpretations;\n      * Impede the patient's ability to complete the entire duration of study.\n     \n     \n 5.  Patients experiencing an asthma exacerbation requiring systemic (oral and/or parenteral) corticosteroids treatment or hospitalization (>24hrs) for treatment of asthma within 4 weeks prior to V1.\n 6.  History of anaphylaxis to any biologic therapy or vaccine.\n 7.  Known history of allergy or reaction to any component of the Investigational Product (IP) formulation.\n 8.  History of Guillain-BarrÃ© syndrome.\n 9.  A helminth parasitic infection diagnosed within 24 weeks prior to V1 and has not been treated with, or has failed to respond to standard of care therapy.\n 10. Current malignancy, or history of malignancy, except for: - Patients who have had basal cell carcinoma, localized squamous cell carcinoma of the skin, or in situ carcinoma of the cervix are eligible provided that patient is in remission and curative therapy was completed at least 12 months prior to V1; - Patients who have had other malignancies are eligible provided that the patient is in remission and curative therapy was completed at least 5 years prior to V1.NOTE: Hormonal therapy is allowed. As long as the cancer is in remission for 5 years, the patient is eligible.\n     \n     \n 11. Any clinically significant cardiac disease or any electrocardiogram (ECG) abnormality obtained during the screening/run-in period, which may put the patient at risk or interfere with study assessments.\n 12. Positive hepatitis B surface antigen, or hepatitis C virus antibody serology (confirmed by additional testing, e.g. hepatitis C RNA test, if indicated), or a positive medical history for hepatitis B or C (Note: Patients with history of hepatitis B vaccination without history of hepatitis B are allowed to enroll).\n 13. History of known immunodeficiency disorder, including a positive human immunodeficiency virus (HIV) test.\n 14. Infection requiring systemic antibiotics (Ab) within 14 days prior to V1\n 15. Use of immunosuppressive medication (including but not limited to: methotrexate, troleandomycin, cyclosporine, azathioprine, or any experimental anti-inflammatory therapy) within 3 months prior to V1.\n 16. Receipt of any marketed or investigational biologic products (monoclonal or polyclonal antibody) within 6 months or 5 half-lives prior to the date informed consent, is obtained, whichever is longer, prior to V1 and during the study period. This also applies to patients who previously participated in clinical studies and were treated with monoclonal antibodies (e.g. mepolizumab, reslizumab, dupilumab, omalizumab). Note that this restriction do not apply to patients, who are confirmed to have only received treatment with placebo.\n 17. Previous receipt of benralizumab.\n 18. Receipt of immunoglobulin or blood products within 30 days prior to V1.\n 19. Receipt of live attenuated vaccines 30 days prior to the date of randomization.\n 20. Receipt of any investigational drug within 30 days or 5 half-lives whichever is longer prior to randomization.\n 21. Receipt of systemic corticosteroid 4 weeks prior to V1, or a scheduled systemic corticosteroid treatment during the study period.NOTE: Sustained release steroids (e.g. Kenalog [Triamcinolone acetonide]) or depot injections require minimum 6 weeks washout prior to V1.\n     \n     \n 22. Receipt of leukotriene antagonist/modifiers for patients who were not on a continuous stable dose for â‰¥30 days prior to V1.\n 23. Concurrent enrolment in another clinical drug interventional trial.\n 24. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level â‰¥ 3 times the upper limit of normal (ULN) confirmed during screening period.\n 25. Previous randomization in the present study.\n 26. Planned major surgical procedures or scheduled NP surgery at the time of the study enrolment and randomization.\n 27. Initiated or is being maintained on an aspirin desensitization regimen for the management of aspirin exacerbated respiratory disease (AERD) at the time of study enrolment or during the run-in period.\n 28. For women only - currently pregnant (or intend to become pregnant), breastfeeding or lactating.",{"$nulls":4},"Actual","2018-01-17","Actual","Anticipated","2020-09-04","Anticipated","2019-04-01","2017-12-13","2018-01-09","2019-04-23","No","Polyps\nNasal polyps\nNasal polyposis\nNose diseases\nRespiratory tract diseases\nOtorhinolaryngologic diseases\nBenralizumab\nMometasone furoate","Interventional","Treatment","Parallel Assignment","Triple (Participant, Care Provider, Investigator)","Randomized","18 Years","75 Years","All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"2017-003675-61","EudraCT Number","Effect of benralizumab on nasal polyp burden|Effect of benralizumab on patient reported nasal blockage (NB)","Change from baseline in endoscopic total nasal polyp score (NPS). NPS (maximum 8) is the sum of the right and left nostril scores|Change from baseline in mean nasal blockage score (NBS). NBS is assessed in daily diary by asking patients to rate the severity of their worst nasal blockage over the past 24 hours using the following response options: 0 - None; 1 - Mild; 2 - Moderate; 3 - Severe","Week 56 (visit 11)","Effect of benralizumab on disease specific health-related quality of life (HRQoL)|Effect of benralizumab on nasal polyp (NP) surgery|Proportion of NP Surgery|Systemic corticosteroids (SCS) use for relief of nasal symptoms|Symptoms associated with nasal polyps|Sinus opacification by computed tomography (CT) scan (subset of patients)|Patient-reported general health status|Other Pre-specified Outcome Measures:|Assessment of the safety of benralizumab|Assessment of the immunogenicity of benralizumab","Change from baseline in SinoNasal Outcome Test (SNOT-22) score. SNOT-22 captures patient-reported physical problems, functional limitations, and emotional consequences of sinonasal condition. It`s patient-reported symptom severity and symptom impact over the past 2 weeks and are captured via a 6-point scale (0- No Problem to 5- Problem as bad as it can be). The total score is the sum of item scores and has a range from 0 to 110|Time to first NP surgery|Proportion of patients with surgery for NP|Proportion of patients with SCS use for NP|Time to first SCS course for NP|Change from baseline in nasal symptom score(s) as captured in the daily diary. Patients report the severity of symptom related to NP at its worst using a 4-point verbal rating scale (0-None to 3-Severe).|Sense of smell captured as change from baseline in University of Pennsylvania Smell Identification Test (UPSIT) score.\n\nIt is a quantitative test of olfactory function which uses microencapsulated odorants that are released by scratching standardized odor-impregnated test booklets. Four booklets each with 10 odorants each are used for the test. Patients are asked to identify the odor using multiple choice format which lists different possibilities. Scores are based on number of correctly identified odors (score range 0 to 40).|Change from baseline in Lund Mackay score|Change from baseline in Short Form 36-item Health survey, Version 2 (SF-36v2)|Total SCS dose used|Number of courses of SCS for NP|Total duration of SCS use for NP|Change from baseline in sinus severity score by Quantitative CT analysis|Other Pre-specified Outcome Measures:|Numbers of adverse events (AEs) and serious adverse events (SAEs)|Presence and absence of benralizumab anti-drug antibodies (ADA)","Week 56 (visit 11)|by Week 56 (visit 11)","information.center@astrazeneca.com","AstraZeneca Clinical Study Information Center","1-877-240-9479","[Active, Not Recruiting]Graz, Austria, 8036 Research SiteInnsbruck, Austria, 6020 Research Site[Active, Not Recruiting]Linz, Austria, 4010 Research Site[Active, Not Recruiting]Salzburg, Austria, 5020 Research Site[Active, Not Recruiting]St. PÃ¶lten, Austria, 3100 Research Site[Active, Not Recruiting]Wien, Austria, 1090|Brussels, Belgium, 1200 Research SiteGent, Belgium, 9000 Research SiteLeuven, Belgium, 3000|Vancouver, British Columbia, Canada, V5Z 1M9|Hamilton, Ontario, Canada, L8N 3Z5 Research SiteHamilton, Ontario, Canada, L8S 1G5 Research SiteLondon, Ontario, Canada, N6A 4V2 Research SiteMississauga, Ontario, Canada, L5A 3V4 Research SiteOttawa, Ontario, Canada, K1G 6C6|Montreal, Quebec, Canada, H2X 3E4 Research SiteMontreal, Quebec, Canada, H3G 1L5 Research SiteMontreal, Quebec, Canada, H4A 3J1 Research SiteQuebec City, Quebec, Canada, G1V 4W2 Research SiteTrois-RiviÃ¨res, Quebec, Canada, G8T 7A1|Quebec, Canada, G1V 4G5|Aarhus N, Denmark, 8200 Research SiteHillerÃ¸d, Denmark, 3400 Research SiteHvidovre, Denmark, 2650 Research SiteKÃ¸benhavn Nv, Denmark, 2400 Research SiteKÃ¸ge, Denmark, 4600 Research SiteNÃ¦stved, Denmark, 4700 Research SiteOdense, Denmark, 5000 Research SiteVejle, Denmark, 7100 Research SiteÃ…lborg, Denmark, 9000|[Active, Not Recruiting]Aschaffenburg, Germany, 63739 Research Site[Active, Not Recruiting]Berlin, Germany, 13353 Research Site[Active, Not Recruiting]Dreieich, Germany, 63303 Research Site[Active, Not Recruiting]Dresden, Germany, 01307 Research Site[Active, Not Recruiting]DÃ¼sseldorf, Germany, 40225 Research Site[Active, Not Recruiting]GÃ¶ttingen, Germany, 37073 Research Site[Active, Not Recruiting]Heidelberg, Germany, 69120 Research SiteLÃ¼beck, Germany, 23538 Research SiteMÃ¼nster, Germany, 48149 Research SiteWiesbaden, Germany, 65183|[Active, Not Recruiting]Budapest, Hungary, 1083 Research Site[Active, Not Recruiting]Budapest, Hungary, 1106 Research Site[Active, Not Recruiting]Debrecen, Hungary, 4032 Research Site[Active, Not Recruiting]Eger, Hungary, 3300 Research Site[Active, Not Recruiting]NyÃ­regyhÃ¡za, Hungary, 4400 Research Site[Active, Not Recruiting]PÃ©cs, Hungary, 7621 Research Site[Active, Not Recruiting]VeszprÃ©m, Hungary, 8200|Nadarzyn, Poland, 05-830 Research SiteStrzelce Opolskie, Poland, 47-100 Research SiteWarszawa, Poland, 02-547 Research SiteWrocÅ‚aw, Poland, 50-220 Research SiteWrocÅ‚aw, Poland, 53-301 Research SiteÅ\u0081Ã³dÅº, Poland, 90-153|Birmingham, Alabama, United States, 35209|Peoria, Arizona, United States, 85381|Fresno, California, United States, 93720 Research SiteHuntington Beach, California, United States, 92647 Research SiteLa Mesa, California, United States, 91942 Research SiteLos Angeles, California, United States, 90048 Research SiteLos Angeles, California, United States, 90095-1624 Research SiteLos Angeles, California, United States, 90095 Research SiteOrange, California, United States, 92868 Research SiteRoseville, California, United States, 95661 Research SiteWalnut Creek, California, United States, 94598|Centennial, Colorado, United States, 80112 Research SiteGlenwood Springs, Colorado, United States, 81601 United States, District Of Columbia Research SiteWashington, District Of Columbia, United States, 20037|Boca Raton, Florida, United States, 33487 Research SiteLake Mary, Florida, United States, 32746|Atlanta, Georgia, United States, 30308 Research SiteDecatur, Georgia, United States, 30030|Chicago, Illinois, United States, 60611 Research SiteChicago, Illinois, United States, 60647 Research SiteChicago, Illinois, United States, 60657|Des Moines, Iowa, United States, 50312 Research SiteWest Des Moines, Iowa, United States, 50265|Kansas City, Kansas, United States, 66160|Louisville, Kentucky, United States, 40207|Baltimore, Maryland, United States, 21224|Boston, Massachusetts, United States, 02111 Research SiteBoston, Massachusetts, United States, 02114|Rochester, Minnesota, United States, 55905|Lincoln, Nebraska, United States, 68505|Bronx, New York, United States, 10461 Research SiteHewlett, New York, United States, 11557 Research SiteNew Hyde Park, New York, United States, 11040 Research SiteNew Windsor, New York, United States, 12553 Research SiteNew York, New York, United States, 10001 Research SiteNew York, New York, United States, 10006 Research SiteNew York, New York, United States, 10011 Research SiteNew York, New York, United States, 10013 Research SiteNew York, New York, United States, 10016 Research SiteNew York, New York, United States, 10016 Research SiteNew York, New York, United States, 10021 Research SiteNew York, New York, United States, 10022 Research SiteNew York, New York, United States, 10028 Research SiteNew York, New York, United States, 10028 Research SiteNew York, New York, United States, 10075 Research SiteNew York, New York, United States, 10128 Research SitePlainview, New York, United States, 11803 Research SiteWhite Plains, New York, United States, 10605|Charlotte, North Carolina, United States, 28210 Research SiteConcord, North Carolina, United States, 28025 Research SitePinehurst, North Carolina, United States, 28374 Research SiteWinston-Salem, North Carolina, United States, 27103|Middleburg Heights, Ohio, United States, 44130|Oklahoma City, Oklahoma, United States, 73120|Medford, Oregon, United States, 97504 Research SitePortland, Oregon, United States, 97239|Bethlehem, Pennsylvania, United States, 18017 Research SitePhiladelphia, Pennsylvania, United States, 19104 Research SitePhiladelphia, Pennsylvania, United States, 19107 Research SitePhiladelphia, Pennsylvania, United States, 19111 Research SitePittsburgh, Pennsylvania, United States, 15213|Charleston, South Carolina, United States, 29425 Research SiteOrangeburg, South Carolina, United States, 29118|Boerne, Texas, United States, 78006 Research SiteConroe, Texas, United States, 77304 Research SiteHouston, Texas, United States, 77030|North Logan, Utah, United States, 84341 Research SiteSaint George, Utah, United States, 84790|Charlottesville, Virginia, United States, 22903 Research SiteNorfolk, Virginia, United States, 23507 Research SiteRichmond, Virginia, United States, 23236-1968|Spokane Valley, Washington, United States, 99216|Fairmont, West Virginia, United States, 26554","Alabama|Arizona|California|Colorado|Florida|Georgia|Illinois|Iowa|Kansas|Kentucky|Maryland|Massachusetts|Minnesota|Nebraska|New York|North Carolina|Ohio|Oklahoma|Oregon|Pennsylvania|South Carolina|Texas|Utah|Virginia|Washington|West Virginia","Austria|Belgium|Canada|Denmark|Germany|Hungary|Poland|United States","Research Site|British Columbia Research Site|Ontario Research Site|Quebec Research Site",{"$nulls":4},"2019-04-23","2020-05-25T16:37:17.434","2020-05-26T17:10:42.972","NCT03401229"]
["5ecbf43de2561b1b11905d93","NCT03401229","2019-10-31","AstraZeneca","AZN","Active, not recruiting","Efficacy and Safety Study of Benralizumab for Patients With Severe Nasal Polyposis (OSTRO)","Benralizumab|Mometasone","IL5 Inhibitor|GR Agonist","No",null,"No",null,"Phase 3",2,413,"Actual","2018-01-15","2020-08-07",{"$nulls":5},"The aim of this present study is to investigate the use of benralizumab as treatment for severe nasal polyposis. The effect of benralizumab on nasal polyps will be assessed over a 56 weeks of treatment period in patients with severe bilateral nasal polyposis who are still symptomatic despite standard of care therapy, i.e current use of intranasal corticosteroids (INCS) and prior surgery and/or use of systemic corticosteroids. The first 200 patients that complete the 56-week treatment will have a 6 month follow-up (FU) period without dosing.",null,"A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Phase 3 Efficacy and Safety Study Of Benralizumab in Patients With Severe Nasal Polyposis","D3252C00001","Nasal Polyposis","Nasal Polyposis","Nose Diseases","Respiratory","Experimental|Placebo Comparator","Benralizumab 30mg SC + MF|Placebo SC + MF","SC - subcutaneously MF - Mometasone Furoate","Biological","Benralizumab 30 mg SC + Mometasone Furoate|Matching placebo SC + Mometasone Furoate",null,null,"Benralizumab 30mg SC + MF|Placebo SC + MF","\n\n 1.  Capable of giving signed informed consent, which includes compliance with the requirements and restrictions, listed in the informed consent form (ICF) and in protocol.\n 2.  Provision of signed and dated, written informed consent form (ICF) prior to any mandatory study specific procedures, sampling, and analyses and according to international guidelines and/or applicable European Union (EU) guidelines.\n 3.  Provision of signed and dated written genetic informed consent in patients that agree to participate in the genetic sampling, prior to collection of sample for genetic analysis.\n 4.  Female or male patients aged 18 to 75 years inclusive, at the time of signing the ICF.\n 5.  Patients with bilateral sinonasal polyposis that, despite treatment with a stable dose of intranasal corticosteroids (INCS) for at least 4 weeks prior to V1, in addition to history of treatment with systemic (SCS -oral, parenteral) or prior surgery for nasal polyposis (NP), have severity consistent with a need for surgery as described by: * A minimum total Nasal Polyp Score (NPS) of 5 out of a maximum score of 8 (with a unilateral score of at least 2 for each nostril) at V1, and continuously maintained at V2 to meet the randomization criterion, as determined by the study Imaging Core Lab;\n      * Ongoing symptoms for at least 12 weeks prior to V1;\n      * Patient-reported moderate to severe nasal blockage score (NBS) 2 or 3 over the 2-weeks prior to V1 (2-week recall assessment of symptoms, scores 0-none to 3-severe).\n     \n     \n 6.  SNOT-22 total score â‰¥ 30 at enrolment.Patient must meet the following criteria (points 7-10) at the randomization visit:\n     \n     \n 7.  At least 8 days of evaluable daily diary data in the 14-day period prior to randomization (baseline bi-weekly mean score collected from study Day -13 to study Day 0).\n 8.  At randomization, a bi-weekly mean NBS â‰¥ 1.5.\n 9.  SNOT-22 total score â‰¥ 30 at randomization.\n 10. At least 70% compliance with INCS during the run-in period based on daily diary.\n 11. Patients with a minimum weight of 40kg.\n 12. Negative serum pregnancy test result and a negative urine pregnancy test at randomization for female patients of childbearing potential.\n 13. Women of childbearing potential (WOCBP) must use an effective form of birth control as defined in the Clinical Study Protocol (CSP).\n\n15. Male subjects who are sexually active must be surgically sterile at least one year prior to Visit 1 or must use an adequate method of contraception (condom or condom with spermicide depending on local regulations) from the first dose of IP until 16 weeks after their last dose. Men with a partner or partners who is (are) not of childbearing potential are exempt of these requirements\n\n","\n\n 1.  Patients who have undergone any nasal and/or sinus surgery within 3 months prior to V1.\n 2.  Patients with conditions or concomitant disease that makes them non evaluable for the co-primary efficacy endpoint such as: * Unilateral antrochoanal polyps;\n      * Nasal septal deviation that occludes at least one nostril;\n      * Acute sinusitis, nasal infection, or upper respiratory infection at screening or in the 2 weeks before screening;\n      * Current rhinitis medicamentosa;\n      * Allergic fungal rhinosinusitis (AFRS) or Allergic fungal sinusitis (AFS);\n      * Nasal cavity tumors.\n     \n     \n 3.  Clinically important comorbidities that could confound interpretation of clinical efficacy results including, but not limited to: active upper or lower respiratory tract infection, cystic fibrosis, primary ciliary dyskinesia, eosinophilic diseases other than asthma (e.g. allergic bronchopulmonary aspergillosis/mycosis, eosinophilic granulomatosis with polyangitis [Churg-Strauss syndrome], hypereosinophilic syndromes), granulomatosis with polyangitis (Wegener's granulomatosis), Young's syndrome, etc.\n 4.  Any disorder, including but not limited to: cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric, or major physical impairment that is not stable in the opinion of the Investigator or AstraZeneca and could: * Affect the safety of the patient throughout the study;\n      * Influence the findings of the studies or their interpretations;\n      * Impede the patient's ability to complete the entire duration of study.\n     \n     \n 5.  Patients experiencing an asthma exacerbation requiring systemic (oral and/or parenteral) corticosteroids treatment or hospitalization (>24hrs) for treatment of asthma within 4 weeks prior to V1.\n 6.  History of anaphylaxis to any biologic therapy or vaccine.\n 7.  Known history of allergy or reaction to any component of the Investigational Product (IP) formulation.\n 8.  History of Guillain-BarrÃ© syndrome.\n 9.  A helminth parasitic infection diagnosed within 24 weeks prior to V1 and has not been treated with, or has failed to respond to standard of care therapy.\n 10. Current malignancy, or history of malignancy, except for: - Patients who have had basal cell carcinoma, localized squamous cell carcinoma of the skin, or in situ carcinoma of the cervix are eligible provided that patient is in remission and curative therapy was completed at least 12 months prior to V1; - Patients who have had other malignancies are eligible provided that the patient is in remission and curative therapy was completed at least 5 years prior to V1.NOTE: Hormonal therapy is allowed. As long as the cancer is in remission for 5 years, the patient is eligible.\n     \n     \n 11. Any clinically significant cardiac disease or any electrocardiogram (ECG) abnormality obtained during the screening/run-in period, which may put the patient at risk or interfere with study assessments.\n 12. Positive hepatitis B surface antigen, or hepatitis C virus antibody serology (confirmed by additional testing, e.g. hepatitis C RNA test, if indicated), or a positive medical history for hepatitis B or C (Note: Patients with history of hepatitis B vaccination without history of hepatitis B are allowed to enroll).\n 13. History of known immunodeficiency disorder, including a positive human immunodeficiency virus (HIV) test.\n 14. Infection requiring systemic antibiotics (Ab) within 14 days prior to V1\n 15. Use of immunosuppressive medication (including but not limited to: methotrexate, troleandomycin, cyclosporine, azathioprine, or any experimental anti-inflammatory therapy) within 3 months prior to V1.\n 16. Receipt of any marketed or investigational biologic products (monoclonal or polyclonal antibody) within 6 months or 5 half-lives prior to the date informed consent, is obtained, whichever is longer, prior to V1 and during the study period. This also applies to patients who previously participated in clinical studies and were treated with monoclonal antibodies (e.g. mepolizumab, reslizumab, dupilumab, omalizumab). Note that this restriction do not apply to patients, who are confirmed to have only received treatment with placebo.\n 17. Previous receipt of benralizumab.\n 18. Receipt of immunoglobulin or blood products within 30 days prior to V1.\n 19. Receipt of live attenuated vaccines 30 days prior to the date of randomization.\n 20. Receipt of any investigational drug within 30 days or 5 half-lives whichever is longer prior to randomization.\n 21. Receipt of systemic corticosteroid 4 weeks prior to V1, or a scheduled systemic corticosteroid treatment during the study period.NOTE: Sustained release steroids (e.g. Kenalog [Triamcinolone acetonide]) or depot injections require minimum 6 weeks washout prior to V1.\n     \n     \n 22. Receipt of leukotriene antagonist/modifiers for patients who were not on a continuous stable dose for â‰¥30 days prior to V1.\n 23. Concurrent enrolment in another clinical drug interventional trial.\n 24. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level â‰¥ 3 times the upper limit of normal (ULN) confirmed during screening period.\n 25. Previous randomization in the present study.\n 26. Planned major surgical procedures or scheduled NP surgery at the time of the study enrolment and randomization.\n 27. Initiated or is being maintained on an aspirin desensitization regimen for the management of aspirin exacerbated respiratory disease (AERD) at the time of study enrolment or during the run-in period.\n 28. For women only - currently pregnant (or intend to become pregnant), breastfeeding or lactating.",{"$nulls":4},"Actual","2018-01-17","Actual","Anticipated","2020-08-07","Anticipated","2019-10-01","2017-12-13","2018-01-09","2019-10-30","No","Polyps\nNasal polyps\nNasal polyposis\nNose diseases\nRespiratory tract diseases\nOtorhinolaryngologic diseases\nBenralizumab\nMometasone furoate","Interventional","Treatment","Parallel Assignment","Triple (Participant, Care Provider, Investigator)","Randomized","18 Years","75 Years","All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"2017-003675-61","EudraCT Number","Effect of benralizumab on nasal polyp burden|Effect of benralizumab on patient reported nasal blockage (NB)","Change from baseline in endoscopic total nasal polyp score (NPS). NPS (maximum 8) is the sum of the right and left nostril scores|Change from baseline in mean nasal blockage score (NBS). NBS is assessed in daily diary by asking patients to rate the severity of their worst nasal blockage over the past 24 hours using the following response options: 0 - None; 1 - Mild; 2 - Moderate; 3 - Severe","Week 56 (visit 11)","Effect of benralizumab on disease specific health-related quality of life (HRQoL)|Effect of benralizumab on nasal polyp (NP) surgery|Proportion of NP Surgery|Systemic corticosteroids (SCS) use for relief of nasal symptoms|Symptoms associated with nasal polyps|Sinus opacification by computed tomography (CT) scan (subset of patients)|Patient-reported general health status|Other Pre-specified Outcome Measures:|Assessment of the safety of benralizumab|Assessment of the immunogenicity of benralizumab","Change from baseline in SinoNasal Outcome Test (SNOT-22) score. SNOT-22 captures patient-reported physical problems, functional limitations, and emotional consequences of sinonasal condition. It`s patient-reported symptom severity and symptom impact over the past 2 weeks and are captured via a 6-point scale (0- No Problem to 5- Problem as bad as it can be). The total score is the sum of item scores and has a range from 0 to 110|Time to first NP surgery|Proportion of patients with surgery for NP|Proportion of patients with SCS use for NP|Time to first SCS course for NP|Change from baseline in nasal symptom score(s) as captured in the daily diary. Patients report the severity of symptom related to NP at its worst using a 4-point verbal rating scale (0-None to 3-Severe).|Sense of smell captured as change from baseline in University of Pennsylvania Smell Identification Test (UPSIT) score.\n\nIt is a quantitative test of olfactory function which uses microencapsulated odorants that are released by scratching standardized odor-impregnated test booklets. Four booklets each with 10 odorants each are used for the test. Patients are asked to identify the odor using multiple choice format which lists different possibilities. Scores are based on number of correctly identified odors (score range 0 to 40).|Change from baseline in Lund Mackay score|Change from baseline in Short Form 36-item Health survey, Version 2 (SF-36v2)|Total SCS dose used|Number of courses of SCS for NP|Total duration of SCS use for NP|Change from baseline in sinus severity score by Quantitative CT analysis|Other Pre-specified Outcome Measures:|Numbers of adverse events (AEs) and serious adverse events (SAEs)|Presence and absence of benralizumab anti-drug antibodies (ADA)","Week 56 (visit 11)|by Week 56 (visit 11)",{"$nulls":3},"Graz, Austria, 8036 Research SiteLinz, Austria, 4010 Research SiteSalzburg, Austria, 5020 Research SiteSt. PÃ¶lten, Austria, 3100 Research SiteWien, Austria, 1090|Brussels, Belgium, 1200 Research SiteGent, Belgium, 9000 Research SiteLeuven, Belgium, 3000|Vancouver, British Columbia, Canada, V5Z 1M9|Hamilton, Ontario, Canada, L8S 1G5 Research SiteLondon, Ontario, Canada, N6A 4V2 Research SiteMississauga, Ontario, Canada, L5A 3V4 Research SiteOttawa, Ontario, Canada, K1G 6C6|Montreal, Quebec, Canada, H2X 3E4 Research SiteMontreal, Quebec, Canada, H3G 1L5 Research SiteMontreal, Quebec, Canada, H4A 3J1 Research SiteQuebec City, Quebec, Canada, G1V 4W2 Research SiteTrois-RiviÃ¨res, Quebec, Canada, G8T 7A1|Quebec, Canada, G1V 4G5|Aarhus N, Denmark, 8200 Research SiteHillerÃ¸d, Denmark, 3400 Research SiteHvidovre, Denmark, 2650 Research SiteKÃ¸benhavn Nv, Denmark, 2400 Research SiteKÃ¸ge, Denmark, 4600 Research SiteNÃ¦stved, Denmark, 4700 Research SiteOdense C, Denmark, 5000 Research SiteVejle, Denmark, 7100 Research SiteÃ…lborg, Denmark, 9000|Aschaffenburg, Germany, 63739 Research SiteBerlin, Germany, 13353 Research SiteDreieich, Germany, 63303 Research SiteDresden, Germany, 01307 Research SiteDÃ¼sseldorf, Germany, 40225 Research SiteGÃ¶ttingen, Germany, 37073 Research SiteHeidelberg, Germany, 69120 Research SiteLÃ¼beck, Germany, 23538 Research SiteMÃ¼nster, Germany, 48149 Research SiteWiesbaden, Germany, 65183|Budapest, Hungary, 1083 Research SiteBudapest, Hungary, 1106 Research SiteDebrecen, Hungary, 4032 Research SiteEger, Hungary, 3300 Research SiteNyÃ­regyhÃ¡za, Hungary, 4400 Research SitePÃ©cs, Hungary, 7621 Research SiteVeszprÃ©m, Hungary, 8200|Nadarzyn, Poland, 05-830 Research SiteStrzelce Opolskie, Poland, 47-100 Research SiteWarszawa, Poland, 02-547 Research SiteWrocÅ‚aw, Poland, 50-220 Research SiteWrocÅ‚aw, Poland, 53-301 Research SiteÅ\u0081Ã³dÅº, Poland, 90-153|Birmingham, Alabama, United States, 35209|Fresno, California, United States, 93720 Research SiteHuntington Beach, California, United States, 92647 Research SiteLa Mesa, California, United States, 91942 Research SiteLos Angeles, California, United States, 90048 Research SiteLos Angeles, California, United States, 90095-1624 Research SiteOrange, California, United States, 92868 Research SiteRoseville, California, United States, 95661 Research SiteWalnut Creek, California, United States, 94598|Centennial, Colorado, United States, 80112 Research SiteGlenwood Springs, Colorado, United States, 81601 United States, District Of Columbia Research SiteWashington, District Of Columbia, United States, 20037|Lake Mary, Florida, United States, 32746|Atlanta, Georgia, United States, 30308 Research SiteDecatur, Georgia, United States, 30030|Chicago, Illinois, United States, 60611 Research SiteChicago, Illinois, United States, 60657|Des Moines, Iowa, United States, 50312|Kansas City, Kansas, United States, 66160|Louisville, Kentucky, United States, 40207|Baltimore, Maryland, United States, 21224|Boston, Massachusetts, United States, 02111 Research SiteBoston, Massachusetts, United States, 02114|Rochester, Minnesota, United States, 55905|Lincoln, Nebraska, United States, 68505|Bronx, New York, United States, 10461 Research SiteHewlett, New York, United States, 11557 Research SiteNew Windsor, New York, United States, 12553 Research SiteNew York, New York, United States, 10001 Research SiteNew York, New York, United States, 10011 Research SiteNew York, New York, United States, 10016 Research SiteNew York, New York, United States, 10022 Research SiteNew York, New York, United States, 10075 Research SiteNew York, New York, United States, 10128 Research SitePlainview, New York, United States, 11803 Research SiteWhite Plains, New York, United States, 10605|Winston-Salem, North Carolina, United States, 27103|Oklahoma City, Oklahoma, United States, 73120|Philadelphia, Pennsylvania, United States, 19107 Research SitePittsburgh, Pennsylvania, United States, 15213|Charleston, South Carolina, United States, 29425|Conroe, Texas, United States, 77304 Research SiteHouston, Texas, United States, 77030|North Logan, Utah, United States, 84341|Norfolk, Virginia, United States, 23507 Research SiteRichmond, Virginia, United States, 23236-1968|Spokane Valley, Washington, United States, 99216","Alabama|California|Colorado|Florida|Georgia|Illinois|Iowa|Kansas|Kentucky|Maryland|Massachusetts|Minnesota|Nebraska|New York|North Carolina|Oklahoma|Pennsylvania|South Carolina|Texas|Utah|Virginia|Washington","Austria|Belgium|Canada|Denmark|Germany|Hungary|Poland|United States","Research Site|British Columbia Research Site|Ontario Research Site|Quebec Research Site",{"$nulls":4},"2019-10-30","2020-05-25T16:37:17.447","2020-05-26T17:10:42.972","NCT03401229"]
["5ecbf43ffe30261b1a04829c","NCT03401671","2018-01-17","Shire","SHPG","Not yet recruiting","Study of Lanadelumab in Healthy Japanese and Matched Caucasian Adult Subjects","Lanadelumab","KLK Inhibitor","Yes","['Lanadelumab']","No",null,"Phase 1",2,32,"Anticipated","2018-01-15","2018-06-05","AUC|Clast","Area Under The Curve|Last Quantifiable Plasma Concentration",{"$nulls":3},"The purpose of this study is to evaluate the pharmacokinetics (PK), safety and tolerability and pharmacodynamics (PD) of lanadelumab in healthy adult Japanese subjects and matched non-Hispanic healthy adult Caucasian subjects.",null,"A Phase 1, Open-label Study to Evaluate the Pharmacokinetics, Safety and Tolerability, and Pharmacodynamics of a Single Dose of Lanadelumab Administered Subcutaneously in Healthy Adult Japanese Subjects and Matched Healthy Adult Caucasian Subjects","SHP643-101","Healthy Volunteers","Healthy Volunteers","Healthy","Healthy","Experimental","Japanese|Non-Hispanic Caucasians","Healthy subjects of Japanese descent will receive a single dose of 300 milligrams (mg) lanadelumab subcutaneous (SC) injection in the abdomen.|Healthy Non-Hispanic Caucasian subjects will receive a single dose of 300 mg lanadelumab SC injection in the abdomen","Drug","Lanadelumab","SC injection of 300mg in 2mL (150 mg/mL) solution of lanadelumab will be administered as a single dose injection in the abdomen.","SHP643","Japanese|Non-Hispanic Caucasians","\n\n * Ability to voluntarily provide written, signed, and dated informed consent as applicable to participate in the study.\n * An understanding, ability, and willingness to fully comply with study procedures and restrictions.\n * Age 18-55, inclusive, at the time of consent. The date of signature of the informed consent is defined as the beginning of the Screening Period. This inclusion criterion will only be assessed at the first screening visit.\n * Subjects must be either: 1. A subject of Japanese descent born in Japan, who has resided outside of Japan for no longer than 5 years and is of Japanese parentage, defined as having 2 Japanese parents and 4 Japanese grandparents, all born in Japan.\n    2. A non-Hispanic, Caucasian subject who has 2 non-Hispanic, Caucasian parents and 4 non-Hispanic, Caucasian grandparents.\n   \n   \n * Male or non-pregnant, non-lactating female who agrees to comply with any applicable contraceptive requirements of the protocol or females of non-childbearing potential.\n * Considered \"healthy\" by the investigator. Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, as well as a complete physical examination including vital signs, 12-lead ECG, hematology, blood chemistry, and urinalysis.\n * Body mass index between 18.5-33 kilograms per square meter (kg/m^2), inclusive, with a body weight greater than or equal to (â‰¥) 45 kg (99 pounds [lbs]). This inclusion criterion will only be assessed at the screening visit.\n * Willing and able to consume standardized meals during the confinement period of the study. All subjects will be required to consume the identical meals on study days when serial PK and PD blood samples are collected.\n\n","\n\n * History of any hematological, hepatic, respiratory, cardiovascular, renal, neurological or psychiatric disease, gall bladder removal, or current or recurrent disease that could affect the action, absorption, or disposition of the investigational product, or clinical or laboratory assessments.\n * Current or relevant history of physical or psychiatric illness, any medical disorder that may require treatment or make the subject unlikely to complete the study, or any condition that presents undue risk from the investigational product or procedures.\n * Known or suspected intolerance or hypersensitivity to the investigational product, closely related compounds, or any of the stated ingredients.\n * Significant illness, as judged by the investigator, within 2 weeks of the dose of investigational product.\n * Known history of alcohol or other substance abuse within the last year, per the investigator.\n * Donation of blood or blood products (example [e.g], plasma or platelets) within 60 days prior to receiving the dose of investigational product.\n * Within 30 days prior to the dose of investigational product: 1. Have used an investigational product (if elimination half-life is less than [<] 6 days, otherwise 5 half-lives).\n    2. Have been enrolled in a clinical study (including vaccine studies) that, in the investigator's opinion, may impact this Shire-sponsored study.\n   \n   \n * Confirmed systolic blood pressure (BP) greater than (>) 139 millimeter of mercury (mmHg) or <89mmHg, and diastolic BP >89mmHg or <49mmHg.\n * Twelve-lead ECG values (average of triplicate readings) demonstrating QTc >450 milliseconds (msec) (males) or >470msec (females) at the Screening Visit or Day -1.\n * Positive screen for drugs of abuse (that is, amphetamines, benzodiazepines, barbiturates, cocaine, marijuana, opiates, phencyclidine) at Screening, or drugs of abuse or alcohol on Day -1.\n * Male subjects who consume more than 21 units of alcohol per week or 3 units per day. Female subjects who consume more than 14 units of alcohol per week or 2 units per day. One alcohol unit=1 beer or 1 wine (5 ounce [oz]/150 milliliter [mL]) or 1 liquor (1.5oz/40mL) or 0.75oz alcohol.\n * Positive human immunodeficiency virus (HIV), hepatitis B virus surface antigen (HBsAg), or hepatitis C virus.(HCV) antibody screen.\n * Use of tobacco in any form (eg, smoking or chewing) or other nicotine-containing products in any form (eg, gum, patch, electronic). Ex-users must report that they have stopped using tobacco for at least 30 days prior to receiving the dose of investigational product.\n * Routine consumption of more than 2 units of caffeine per day or subjects who experience caffeine withdrawal headaches. One caffeine unit is contained in the following items: one 6oz (180mL) cup of coffee, two 12oz (360mL) cans of cola, one 12oz cup of tea, and three 1oz (85g) chocolate bars. Decaffeinated coffee, tea, or cola are not considered to contain caffeine.\n * Current use of any medication (including over-the-counter, herbal, or homeopathic preparations; with the exception of hormonal replacement therapy or hormonal contraceptives). Current use is defined as use within 14 days of the dose of investigational product.\n * Abnormal laboratory values considered clinically significant, as determined by the investigator at Screening or Day -1.\n * History of any clinically significant surgery or procedure within 8 weeks of receiving the dose of investigational product, as determined by the investigator.",{"$nulls":4},"Actual","2018-01-17","Actual","Anticipated","2018-06-05","Anticipated","2018-01-01","2018-01-10","2018-01-10","2018-01-10","No","Lanadelumab","Interventional","Treatment","Parallel Assignment","None (Open Label)","Non-Randomized","18 Years","55 Years","All",null,"Yes","No",{"$nulls":3},"Yes","No",{"$nulls":19},"Maximum Observed Plasma Concentration (Cmax) of Lanadelumab|Time to Reach Maximum Observed Drug Concentration in Plasma (Tmax) of Lanadelumab|Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) in Plasma of Lanadelumab|Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Lanadelumab|Terminal Elimination Rate Constant (Lambda z) for Lanadelumab|Terminal Half-life (t12) of Lanadelumab|Apparent Clearance (CL/F) of Lanadelumab|Apparent Volume of Distribution (Vdz/F) of Lanadelumab|Body-weight Adjusted Area Under the Concentration-Time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) in Plasma of Lanadelumab|Body-weight Adjusted Maximum Observed Plasma Concentration (Cmax) of Lanadelumab|Body-weight Adjusted Apparent Clearance (CL/F) of Lanadelumab|Body-weight Adjusted Apparent Volume of Distribution (Vdz/F) of Lanadelumab","Cmax is the maximum observed plasma concentration of lanadelumab|Tmax is the time after administration of a drug when the maximum plasma concentration in the body is reached.|AUC0-last is the area under the concentration-time curve from time zero to the last quantifiable concentration of lanadelumab.|AUC0-infinity is the area under the concentration time curve from time zero extrapolated to infinity.|Lambda z is the terminal elimination rate constant associated with the terminal portion of the curve, determined as the negative slope of the terminal log-linear phase of the drug concentration-time curve.|t1/2 is the time required for the plasma concentration of the drug to reach half of its original value.|CL/F is defined as the rate at which a drug is removed from the body.|Vz/F is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.|Body-weight adjusted AUC0-last in plasma will be measured.|Body-weight adjusted Cmax in plasma will be measured.|Body-weight adjusted CL/F will be measured.|Body-weight adjusted Vdz/F will be measured.","Pre-dose, 8, 24, 48, 72, 96 hours (h) post-dose, Days 7, 14, 21, 28, 42, 56, 84, 112|Pre-dose, 8, 24, 48, 72, 96 h post-dose, Days 7, 14, 21, 28, 42, 56, 84, 112","Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) Based on Severity, Seriousness and Causality|Number of Subjects With Clinically Significant Change in Clinical Laboratory Results Reported as an Adverse Event|Number of Subjects With Clinically Significant Change in Vital Signs Reported as an Adverse Event|Number of Subjects With Clinically Significant Change in Electrocardiogram (ECG) Reported as an Adverse Event|Number of Subjects With Clinically Significant Findings in Physical Examination Reported as an Adverse Event|Number of Subjects who Develop Antidrug Antibodies to Lanadelumab","An adverse event (AE) is any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. TEAEs are defined as AEs with onset at the time of or following the first exposure to study drug, or medical conditions present prior to the start of study drug but increasing in severity or relationship at the time of or following the start of treatment, up to the last follow-up visit. Severity of an AE is determined by following definitions: Mild: An event that does not generally interfere with usual activities of daily living; Moderate: An event that interferes with usual activities of daily living, causing discomfort but poses no significant or permanent risk of harm to the research subject; Severe: An AE that interrupts usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention.|Clinical laboratory assessments include hematology, clinical chemistry, coagulation and urinalysis. The investigator will assess out-of-range clinical laboratory values for clinical significance, to indicate whether or not the values are clinically significant.|Vital sign assessments include blood pressure, pulse rate and body temperature. Any changes from baseline in vital signs which are deemed clinically significant by the investigator are to be recorded as an AE.|Twelve-lead ECG will be performed after 5 minutes of rest in the supine position. Any change in ECG assessments which are deemed clinically significant by the investigator are to be reported as AE.|Complete physical examinations will be carried out which include review of the following body systems: general appearance, skin, head, eyes, ears, nose, and throat, spine, neck or thyroid, musculoskeletal, respiratory, cardiovascular, neurological and abdomen (including liver and kidneys). Any changes from the baseline in physical examination findings that are deemed clinically significant by the investigator are to be recorded as an AE.|Plasma samples will be analyzed for presence of antidrug antibodies to lanadelumab. Subjects who show positive results for lanadelumab antibodies will be reported.","From start of study drug administration up to End of Study / Early Discontinuation (Day 112)|Day -1 up to End of Study / Early Discontinuation (Day 112)|Pre-dose up to End of Study / Early Discontinuation (Day 112)|Day 1 pre-dose up to End of Study / Early Discontinuation (Day 112)","ClinicalTransparency@shire.com","Shire Contact","+1 866 842 5335",{"$nulls":7},"Shire Study Physician","2018-01-10","2020-05-25T16:37:19.204","2020-05-26T17:10:42.972","NCT03401671"]
["5ecbf43ffe30261b1a04829b","NCT03401671","2018-02-23","Shire","SHPG","Active, not recruiting","Study of Lanadelumab in Healthy Japanese and Matched Caucasian Adult Subjects","Lanadelumab","KLK Inhibitor","Yes","['Lanadelumab']","No",null,"Phase 1",2,32,"Anticipated","2018-01-15","2018-06-05","AUC|Clast","Area Under The Curve|Last Quantifiable Plasma Concentration",{"$nulls":3},"The purpose of this study is to evaluate the pharmacokinetics (PK), safety and tolerability and pharmacodynamics (PD) of lanadelumab in healthy adult Japanese subjects and matched non-Hispanic healthy adult Caucasian subjects.",null,"A Phase 1, Open-label Study to Evaluate the Pharmacokinetics, Safety and Tolerability, and Pharmacodynamics of a Single Dose of Lanadelumab Administered Subcutaneously in Healthy Adult Japanese Subjects and Matched Healthy Adult Caucasian Subjects","SHP643-101","Healthy Volunteers","Healthy Volunteers","Healthy","Healthy","Experimental","Japanese|Non-Hispanic Caucasians","Healthy subjects of Japanese descent will receive a single dose of 300 milligrams (mg) lanadelumab subcutaneous (SC) injection in the abdomen.|Healthy Non-Hispanic Caucasian subjects will receive a single dose of 300 mg lanadelumab SC injection in the abdomen","Drug","Lanadelumab","SC injection of 300mg in 2mL (150 mg/mL) solution of lanadelumab will be administered as a single dose injection in the abdomen.","SHP643","Japanese|Non-Hispanic Caucasians","\n\n * Ability to voluntarily provide written, signed, and dated informed consent as applicable to participate in the study.\n * An understanding, ability, and willingness to fully comply with study procedures and restrictions.\n * Age 18-55, inclusive, at the time of consent. The date of signature of the informed consent is defined as the beginning of the Screening Period. This inclusion criterion will only be assessed at the first screening visit.\n * Subjects must be either: 1. A subject of Japanese descent born in Japan, who has resided outside of Japan for no longer than 5 years and is of Japanese parentage, defined as having 2 Japanese parents and 4 Japanese grandparents, all born in Japan.\n    2. A non-Hispanic, Caucasian subject who has 2 non-Hispanic, Caucasian parents and 4 non-Hispanic, Caucasian grandparents.\n   \n   \n * Male or non-pregnant, non-lactating female who agrees to comply with any applicable contraceptive requirements of the protocol or females of non-childbearing potential.\n * Considered \"healthy\" by the investigator. Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, as well as a complete physical examination including vital signs, 12-lead ECG, hematology, blood chemistry, and urinalysis.\n * Body mass index between 18.5-33 kilograms per square meter (kg/m^2), inclusive, with a body weight greater than or equal to (â‰¥) 45 kg (99 pounds [lbs]). This inclusion criterion will only be assessed at the screening visit.\n * Willing and able to consume standardized meals during the confinement period of the study. All subjects will be required to consume the identical meals on study days when serial PK and PD blood samples are collected.\n\n","\n\n * History of any hematological, hepatic, respiratory, cardiovascular, renal, neurological or psychiatric disease, gall bladder removal, or current or recurrent disease that could affect the action, absorption, or disposition of the investigational product, or clinical or laboratory assessments.\n * Current or relevant history of physical or psychiatric illness, any medical disorder that may require treatment or make the subject unlikely to complete the study, or any condition that presents undue risk from the investigational product or procedures.\n * Known or suspected intolerance or hypersensitivity to the investigational product, closely related compounds, or any of the stated ingredients.\n * Significant illness, as judged by the investigator, within 2 weeks of the dose of investigational product.\n * Known history of alcohol or other substance abuse within the last year, per the investigator.\n * Donation of blood or blood products (example [e.g], plasma or platelets) within 60 days prior to receiving the dose of investigational product.\n * Within 30 days prior to the dose of investigational product: 1. Have used an investigational product (if elimination half-life is less than [<] 6 days, otherwise 5 half-lives).\n    2. Have been enrolled in a clinical study (including vaccine studies) that, in the investigator's opinion, may impact this Shire-sponsored study.\n   \n   \n * Confirmed systolic blood pressure (BP) greater than (>) 139 millimeter of mercury (mmHg) or <89mmHg, and diastolic BP >89mmHg or <49mmHg.\n * Twelve-lead ECG values (average of triplicate readings) demonstrating QTc >450 milliseconds (msec) (males) or >470msec (females) at the Screening Visit or Day -1.\n * Positive screen for drugs of abuse (that is, amphetamines, benzodiazepines, barbiturates, cocaine, marijuana, opiates, phencyclidine) at Screening, or drugs of abuse or alcohol on Day -1.\n * Male subjects who consume more than 21 units of alcohol per week or 3 units per day. Female subjects who consume more than 14 units of alcohol per week or 2 units per day. One alcohol unit=1 beer or 1 wine (5 ounce [oz]/150 milliliter [mL]) or 1 liquor (1.5oz/40mL) or 0.75oz alcohol.\n * Positive human immunodeficiency virus (HIV), hepatitis B virus surface antigen (HBsAg), or hepatitis C virus.(HCV) antibody screen.\n * Use of tobacco in any form (eg, smoking or chewing) or other nicotine-containing products in any form (eg, gum, patch, electronic). Ex-users must report that they have stopped using tobacco for at least 30 days prior to receiving the dose of investigational product.\n * Routine consumption of more than 2 units of caffeine per day or subjects who experience caffeine withdrawal headaches. One caffeine unit is contained in the following items: one 6oz (180mL) cup of coffee, two 12oz (360mL) cans of cola, one 12oz cup of tea, and three 1oz (85g) chocolate bars. Decaffeinated coffee, tea, or cola are not considered to contain caffeine.\n * Current use of any medication (including over-the-counter, herbal, or homeopathic preparations; with the exception of hormonal replacement therapy or hormonal contraceptives). Current use is defined as use within 14 days of the dose of investigational product.\n * Abnormal laboratory values considered clinically significant, as determined by the investigator at Screening or Day -1.\n * History of any clinically significant surgery or procedure within 8 weeks of receiving the dose of investigational product, as determined by the investigator.",{"$nulls":4},"Actual","2018-01-17","Actual","Anticipated","2018-06-05","Anticipated","2018-02-01","2018-01-10","2018-01-10","2018-02-22","No","Lanadelumab","Interventional","Treatment","Parallel Assignment","None (Open Label)","Non-Randomized","18 Years","55 Years","All",null,"Yes","No",{"$nulls":3},"Yes","No",{"$nulls":19},"Maximum Observed Plasma Concentration (Cmax) of Lanadelumab|Time to Reach Maximum Observed Drug Concentration in Plasma (Tmax) of Lanadelumab|Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) in Plasma of Lanadelumab|Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Lanadelumab|Terminal Elimination Rate Constant (Lambda z) for Lanadelumab|Terminal Half-life (t12) of Lanadelumab|Apparent Clearance (CL/F) of Lanadelumab|Apparent Volume of Distribution (Vdz/F) of Lanadelumab|Body-weight Adjusted Area Under the Concentration-Time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) in Plasma of Lanadelumab|Body-weight Adjusted Maximum Observed Plasma Concentration (Cmax) of Lanadelumab|Body-weight Adjusted Apparent Clearance (CL/F) of Lanadelumab|Body-weight Adjusted Apparent Volume of Distribution (Vdz/F) of Lanadelumab","Cmax is the maximum observed plasma concentration of lanadelumab|Tmax is the time after administration of a drug when the maximum plasma concentration in the body is reached.|AUC0-last is the area under the concentration-time curve from time zero to the last quantifiable concentration of lanadelumab.|AUC0-infinity is the area under the concentration time curve from time zero extrapolated to infinity.|Lambda z is the terminal elimination rate constant associated with the terminal portion of the curve, determined as the negative slope of the terminal log-linear phase of the drug concentration-time curve.|t1/2 is the time required for the plasma concentration of the drug to reach half of its original value.|CL/F is defined as the rate at which a drug is removed from the body.|Vz/F is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.|Body-weight adjusted AUC0-last in plasma will be measured.|Body-weight adjusted Cmax in plasma will be measured.|Body-weight adjusted CL/F will be measured.|Body-weight adjusted Vdz/F will be measured.","Pre-dose, 8, 24, 48, 72, 96 hours (h) post-dose, Days 7, 14, 21, 28, 42, 56, 84, 112|Pre-dose, 8, 24, 48, 72, 96 h post-dose, Days 7, 14, 21, 28, 42, 56, 84, 112","Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) Based on Severity, Seriousness and Causality|Number of Subjects With Clinically Significant Change in Clinical Laboratory Results Reported as an Adverse Event|Number of Subjects With Clinically Significant Change in Vital Signs Reported as an Adverse Event|Number of Subjects With Clinically Significant Change in Electrocardiogram (ECG) Reported as an Adverse Event|Number of Subjects With Clinically Significant Findings in Physical Examination Reported as an Adverse Event|Number of Subjects who Develop Antidrug Antibodies to Lanadelumab","An adverse event (AE) is any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. TEAEs are defined as AEs with onset at the time of or following the first exposure to study drug, or medical conditions present prior to the start of study drug but increasing in severity or relationship at the time of or following the start of treatment, up to the last follow-up visit. Severity of an AE is determined by following definitions: Mild: An event that does not generally interfere with usual activities of daily living; Moderate: An event that interferes with usual activities of daily living, causing discomfort but poses no significant or permanent risk of harm to the research subject; Severe: An AE that interrupts usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention.|Clinical laboratory assessments include hematology, clinical chemistry, coagulation and urinalysis. The investigator will assess out-of-range clinical laboratory values for clinical significance, to indicate whether or not the values are clinically significant.|Vital sign assessments include blood pressure, pulse rate and body temperature. Any changes from baseline in vital signs which are deemed clinically significant by the investigator are to be recorded as an AE.|Twelve-lead ECG will be performed after 5 minutes of rest in the supine position. Any change in ECG assessments which are deemed clinically significant by the investigator are to be reported as AE.|Complete physical examinations will be carried out which include review of the following body systems: general appearance, skin, head, eyes, ears, nose, and throat, spine, neck or thyroid, musculoskeletal, respiratory, cardiovascular, neurological and abdomen (including liver and kidneys). Any changes from the baseline in physical examination findings that are deemed clinically significant by the investigator are to be recorded as an AE.|Plasma samples will be analyzed for presence of antidrug antibodies to lanadelumab. Subjects who show positive results for lanadelumab antibodies will be reported.","From start of study drug administration up to End of Study / Early Discontinuation (Day 112)|Day -1 up to End of Study / Early Discontinuation (Day 112)|Pre-dose up to End of Study / Early Discontinuation (Day 112)|Day 1 pre-dose up to End of Study / Early Discontinuation (Day 112)",{"$nulls":3},"Cypress, California, United States, 90630","California","United States","Wcct Global, Inc.",{"$nulls":3},"Shire Study Physician","2018-02-22","2020-05-25T16:37:19.076","2020-05-26T17:10:42.972","NCT03401671"]
["5ecbf441307e3d1b1f8d9d30","NCT03402087","2018-01-18","Bristol-Myers Squibb","BMY","Not yet recruiting","A Study to Investigate BMS-986165 and Methotrexate in Healthy Male Patients","Methotrexate|Calcium folinate|Bms-986165","DHFR Inhibitor|TS Inhibitor|TYK2 Inhibitor","Yes","['Calcium folinate', 'Bms-986165']","Yes","['TYK2 Inhibitor']","Phase 1",1,12,"Anticipated","2018-01-31","2018-04-08","AUC","Area Under The Curve",{"$nulls":3},"The purpose of this study is to investigate effects of BMS-986165 on blood levels of methotrexate given as a single dose in healthy male patients.",null,"An Open-Label, Single-Sequence Study to Investigate the Effects of BMS-986165 on the Single-Dose Pharmacokinetics of Methotrexate in Healthy Male Subjects","IM011-025","Lupus\nPsoriatic Arthritis","Arthritis|Arthritis, Psoriatic","Joint Diseases|Bone Diseases","Musculoskeletal","Experimental","BMS-986165+Methotrexate+Leucovorin","Three treatments administered","Drug","Methotrexate|Leucovorin|BMS-986165","Specified dose on specified days","MTX|LEU","BMS-986165+Methotrexate+Leucovorin","\n\n * Body Mass Index (BMI): 18.0 - 32.0 kg/m2\n * Normal renal function at screening\n\n","\n\n * Any medical condition that presents a potential risk to the participant and/or that may compromise the objectives of the study, including active, or history of, liver disease\n * Any contraindication indicated in the MTX package insert\n * History or presence of chronic bacterial or viral infection\n * History or presence of an autoimmune disorder\n * Any significant acute or chronic medical illness\n * Active TB requiring treatment or documented latent TB within the previous 3 years\n * Current or recent (within 3 months of study treatment administration) gastrointestinal disease that could affect absorption\n\nOther protocol defined inclusion/exclusion criteria could apply",{"$nulls":4},"Actual","2018-01-18","Actual","Anticipated","2018-04-09","Anticipated","2018-01-01","2018-01-05","2018-01-16","2018-01-16",null,null,"Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","18 Years","50 Years","Male",null,"Yes",null,null,"URL: http://bms.com/studyconnect/Pages/home.aspx [http://bms.com/studyconnect/Pages/home.aspx] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: BMS Clinical Trial Patient Recruiting",null,"Yes","No",{"$nulls":4},"Yes",{"$nulls":12},"2017-004177-13","EudraCT Number","Maximum observed plasma concentration (Cmax)|Time to attain maximum observed plasma concentration (Tmax)|Area under the plasma concentration-time curve up to time T, where T is the last point with concentrations above the lower limit of quantitation [AUC(0-T)]|Area under the plasma concentration-time curve from time 0 to infinity [AUC(INF)]|Terminal elimination rate constant (kel)|Terminal elimination half life, calculated as 0.693/kel (T-HALF)|Apparent oral clearance (CL/F)","Approximately 14 days",null,"Incidence of adverse events (AEs)|Incidence of serious adverse events (SAEs)","Approximately 19 days",null,"Clinical.Trials@bms.com","Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,","please email:","Groningen, Netherlands, 9728 Nz",null,"Netherlands","Local Institution",null,"First line of the email MUST contain NCT # and Site #.",null,"Bristol-Myers Squibb","2018-01-16","2020-05-25T16:37:21.089","2020-05-26T17:10:42.972","NCT03402087"]
["5ecbf441feab101b155308d2","NCT03402087","2018-03-14","Bristol-Myers Squibb","BMY","Recruiting","A Study to Investigate BMS-986165 and Methotrexate in Healthy Male Patients","Methotrexate|Calcium folinate|Bms-986165","DHFR Inhibitor|TS Inhibitor|TYK2 Inhibitor","Yes","['Calcium folinate', 'Bms-986165']","Yes","['TYK2 Inhibitor']","Phase 1",1,12,"Anticipated","2018-01-08","2018-03-25","AUC","Area Under The Curve",{"$nulls":3},"The purpose of this study is to investigate effects of BMS-986165 on blood levels of methotrexate given as a single dose in healthy male patients.",null,"An Open-Label, Single-Sequence Study to Investigate the Effects of BMS-986165 on the Single-Dose Pharmacokinetics of Methotrexate in Healthy Male Subjects","IM011-025","Lupus\nPsoriatic Arthritis","Arthritis|Arthritis, Psoriatic","Joint Diseases|Bone Diseases","Musculoskeletal","Experimental","BMS-986165+Methotrexate+Leucovorin","Three treatments administered","Drug","Methotrexate|Leucovorin|BMS-986165","Specified dose on specified days","MTX|LEU","BMS-986165+Methotrexate+Leucovorin","\n\n * Body Mass Index (BMI): 18.0 - 32.0 kg/m2\n * Normal renal function at screening\n\n","\n\n * Any medical condition that presents a potential risk to the participant and/or that may compromise the objectives of the study, including active, or history of, liver disease\n * Any contraindication indicated in the MTX package insert\n * History or presence of chronic bacterial or viral infection\n * History or presence of an autoimmune disorder\n * Any significant acute or chronic medical illness\n * Active TB requiring treatment or documented latent TB within the previous 3 years\n * Current or recent (within 3 months of study treatment administration) gastrointestinal disease that could affect absorption\n\nOther protocol defined inclusion/exclusion criteria could apply",{"$nulls":4},"Actual","2018-01-18","Actual","Anticipated","2018-03-26","Anticipated","2018-03-01","2018-01-05","2018-01-16","2018-03-13",null,null,"Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","18 Years","50 Years","Male",null,"Yes",null,null,"URL: http://bms.com/studyconnect/Pages/home.aspx [http://bms.com/studyconnect/Pages/home.aspx] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: BMS Clinical Trial Patient Recruiting",null,"Yes","No",{"$nulls":4},"Yes",{"$nulls":12},"2017-004177-13","EudraCT Number","Maximum observed plasma concentration (Cmax)|Time to attain maximum observed plasma concentration (Tmax)|Area under the plasma concentration-time curve up to time T, where T is the last point with concentrations above the lower limit of quantitation [AUC(0-T)]|Area under the plasma concentration-time curve from time 0 to infinity [AUC(INF)]|Terminal elimination rate constant (kel)|Terminal elimination half life, calculated as 0.693/kel (T-HALF)|Apparent oral clearance (CL/F)","Approximately 14 days",null,"Incidence of adverse events (AEs)|Incidence of serious adverse events (SAEs)","Approximately 19 days",null,"Clinical.Trials@bms.com","Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,","please email:","Salt Lake City, Utah, United States, 84107","Utah","United States","Local Institution",null,"First line of the email MUST contain NCT # and Site #.",null,"Bristol-Myers Squibb","2018-03-13","2020-05-25T16:37:21.556","2020-05-26T17:10:42.972","NCT03402087"]
["5ecbf44111702c1b1b916ab1","NCT03402087","2018-04-23","Bristol-Myers Squibb","BMY","Completed","A Study to Investigate BMS-986165 and Methotrexate in Healthy Male Patients","Methotrexate|Calcium folinate|Bms-986165","DHFR Inhibitor|TS Inhibitor|TYK2 Inhibitor","Yes","['Calcium folinate', 'Bms-986165']","Yes","['TYK2 Inhibitor']","Phase 1",1,30,"Actual","2018-01-08","2018-03-20","AUC","Area Under The Curve",{"$nulls":3},"The purpose of this study is to investigate effects of BMS-986165 on blood levels of methotrexate given as a single dose in healthy male patients.",null,"An Open-Label, Single-Sequence Study to Investigate the Effects of BMS-986165 on the Single-Dose Pharmacokinetics of Methotrexate in Healthy Male Subjects","IM011-025","Lupus\nPsoriatic Arthritis","Arthritis|Arthritis, Psoriatic","Joint Diseases|Bone Diseases","Musculoskeletal","Experimental","BMS-986165+Methotrexate+Leucovorin","Three treatments administered","Drug","Methotrexate|Leucovorin|BMS-986165","Specified dose on specified days","MTX|LEU","BMS-986165+Methotrexate+Leucovorin","\n\n * Body Mass Index (BMI): 18.0 - 32.0 kg/m2\n * Normal renal function at screening\n\n","\n\n * Any medical condition that presents a potential risk to the participant and/or that may compromise the objectives of the study, including active, or history of, liver disease\n * Any contraindication indicated in the MTX package insert\n * History or presence of chronic bacterial or viral infection\n * History or presence of an autoimmune disorder\n * Any significant acute or chronic medical illness\n * Active TB requiring treatment or documented latent TB within the previous 3 years\n * Current or recent (within 3 months of study treatment administration) gastrointestinal disease that could affect absorption\n\nOther protocol defined inclusion/exclusion criteria could apply",{"$nulls":4},"Actual","2018-01-18","Actual","Actual","2018-03-25","Actual","2018-04-01","2018-01-05","2018-01-16","2018-04-20",null,null,"Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","18 Years","50 Years","Male",null,"Yes",null,null,"URL: http://bms.com/studyconnect/Pages/home.aspx [http://bms.com/studyconnect/Pages/home.aspx] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: BMS Clinical Trial Patient Recruiting",null,"Yes","No",{"$nulls":4},"Yes",{"$nulls":12},"2017-004177-13","EudraCT Number","Maximum observed plasma concentration (Cmax)|Time to attain maximum observed plasma concentration (Tmax)|Area under the plasma concentration-time curve up to time T, where T is the last point with concentrations above the lower limit of quantitation [AUC(0-T)]|Area under the plasma concentration-time curve from time 0 to infinity [AUC(INF)]|Terminal elimination rate constant (kel)|Terminal elimination half life, calculated as 0.693/kel (T-HALF)|Apparent oral clearance (CL/F)","Approximately 14 days",null,"Incidence of adverse events (AEs)|Incidence of serious adverse events (SAEs)","Approximately 19 days",{"$nulls":4},"Groningen, Netherlands, 9728 Nz",null,"Netherlands","Local Institution",{"$nulls":3},"Bristol-Myers Squibb","2018-04-20","2020-05-25T16:37:21.244","2020-05-26T17:10:42.972","NCT03402087"]
["5ecbf443e2561b1b11905da2","NCT03402438","2018-01-29","Bayer","BAYN","Not yet recruiting","Renal Impairment Study","Bay-1142524","Chymase Inhibitor","Yes","['Bay-1142524']","Yes","['Chymase Inhibitor']","Phase 1",4,45,"Anticipated","2018-02-12","2018-10-19","AUC","Area Under The Curve",{"$nulls":3},"The study will investigate the pharmacokinetics of BAY1142524 in subjects with mild to severe renal impairment compared to age; weight, and gender-matched healthy subjects.",null,"Investigation of Pharmacokinetics, Safety, and Tolerability of a Single Oral 25 mg BAY 1142524 IR Tablet Dose in Male and Female Subjects With Renal Impairment and in Age-, Gender-, and Weight-matched Healthy Subjects in a Single Center, Non-controlled, Open-label, Observational Design",18106,"Clinical Trial, Phase I","Healthy Volunteers","Healthy","Healthy","Experimental","Normal (healthy subjects)|Mildly renal impaired|Moderately renal impaired|Severely renal impaired","Healthy subjects matched for age, body weight and gender to the groups with renal impairment|Subjects with renal impairment and an estimated glomerular function rate between equal or above 60 and below 90 ml/min/1.75 m*2|Subjects with renal impairment and an estimated glomerular function rate between equal or above 30 and below 60 ml/min/1.75 m*2|Subjects with renal impairment and an estimated glomerular function rate between below 30 ml/min/1.75 m*2","Drug","BAY1142524","single oral dose of 25 mg immediate-release tablet BAY1142524",null,"Normal (healthy subjects)|Mildly renal impaired|Moderately renal impaired|Severely renal impaired","\n\n * Body mass index (BMI): 18 to 34 kg/mÂ² (both inclusive)\n * Men or confirmed postmenopausal women (by medical report verification and defined as exhibiting natural amenorrhea for at least 12 months before screening or as exhibiting natural amenorrhea for at least 6 months before screening with documented serum follicle-stimulating hormone levels >40 mIU/mL, provided that no prior hormonal treatment has taken place) or women without childbearing potential based on surgical treatment at least 6 weeks before screening such as bilateral tubal ligation, bilateral oophorectomy or hysterectomy (documented by medical report verification).\n * Subjects with renal impairment:\n\neGFR <90 mL/min/1.73 m*2 determined from serum creatinine 2 -10 days prior to dosing.\n\nStable renal disease, i.e. a serum creatinine value determined at least 3 months before the pre-study visit (e.g. during routine diagnostics) should not vary by more than 20% from the serum creatinine value determined at the pre-study visit\n\n- Healthy subjects eGFR â‰¥90 mL/min/1.73 m*2 determined from serum creatinine 2 -10 days prior to dosing.\n\nNeeds to be within the required age and body weight range of Group 1 (which should not vary by more than+- 10 years and +-10 kg to Groups 2-4).\n\n","\n\n * Clinically relevant findings(e.g. blood pressure, electrocardiogram, ECG; physical examination,laboratory examination)\n * Relevant impairment in liver function.\n * Pre-existing diseases (including impairment of liver function) for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal.\n * Any organ transplant < 1 year before participation in this study.\n * Subject under dialysis or planned to start dialysis during participation in the study.\n * Failure of any other major organ system other than the kidney.","EGFR","epidermal growth factor receptor","Protein","Ovary, Breast, Lung","Actual","2018-01-18","Actual","Anticipated","2018-11-21","Anticipated","2018-01-01","2018-01-11","2018-01-11","2018-01-26","No",null,"Interventional","Other","Single Group Assignment","None (Open Label)","Non-Randomized","18 Years","79 Years","All",null,"Yes",{"$nulls":4},"No","No",{"$nulls":17},"2017-003301-17","EudraCT Number","Area under the concentration vs. time curve from zero to infinity after single (first) dose (AUC) of BAY1142524|Maximum observed drug concentration in measured matrix after single dose administration (Cmax) of BAY1142524|AUC of unbound drug (AUCu) of BAY1142524|Cmax of unbound drug (Cmax,u) of BAY1142524","AUC(0-tlast) will be used if mean AUC(tlast âˆž) >20% of AUC)|Pre-dose,0.25,0.5,0.75,1,1.5,2,3,4,6,8,10,12,15,24,36,48,96hours post dose|AUC (0-tlast) u will be used if mean AUC (tlast âˆž) >20% of AUC). An additional blood sample for fu will be collected at 2 hours after dosing.|An additional blood sample for fu will be collected at 2 hours after dosing.","Pre-dose,0.25,0.5,0.75,1,1.5,2,3,4,6,8,10,12,15,24,36,48,96hours post dose","Number of subject with treatment emergent adverse events (TEAEs) as a measure of safety and tolerability","up to 10 days after dosing",null,"clinical-trials-contact@bayer.com","Bayer Clinical Trials Contact","(+) 1-888-8422937","Kiel, Schleswig-Holstein, Germany, 24105",null,"Germany","Schleswig-Holstein Crs Clinical-Research-Services Kiel Gmbh",{"$nulls":3},"Bayer Study Director","2018-01-26","2020-05-25T16:37:23.422","2020-05-26T17:10:42.972","NCT03402438"]
["5ecbf44311702c1b1b916ab7","NCT03402438","2018-03-29","Bayer","BAYN","Recruiting","Renal Impairment Study","Bay-1142524","Chymase Inhibitor","Yes","['Bay-1142524']","Yes","['Chymase Inhibitor']","Phase 1",4,45,"Anticipated","2018-02-12","2018-10-19","AUC","Area Under The Curve",{"$nulls":3},"The study will investigate the pharmacokinetics of BAY1142524 in subjects with mild to severe renal impairment compared to age; weight, and gender-matched healthy subjects.",null,"Investigation of Pharmacokinetics, Safety, and Tolerability of a Single Oral 25 mg BAY 1142524 IR Tablet Dose in Male and Female Subjects With Renal Impairment and in Age-, Gender-, and Weight-matched Healthy Subjects in a Single Center, Non-controlled, Open-label, Observational Design",18106,"Clinical Trial, Phase I","Healthy Volunteers","Healthy","Healthy","Experimental","Normal (healthy subjects)|Mildly renal impaired|Moderately renal impaired|Severely renal impaired","Healthy subjects matched for age, body weight and gender to the groups with renal impairment|Subjects with renal impairment and an estimated glomerular function rate between equal or above 60 and below 90 ml/min/1.75 m*2|Subjects with renal impairment and an estimated glomerular function rate between equal or above 30 and below 60 ml/min/1.75 m*2|Subjects with renal impairment and an estimated glomerular function rate between below 30 ml/min/1.75 m*2","Drug","BAY1142524","single oral dose of 25 mg immediate-release tablet BAY1142524",null,"Normal (healthy subjects)|Mildly renal impaired|Moderately renal impaired|Severely renal impaired","\n\n * Body mass index (BMI): 18 to 34 kg/mÂ² (both inclusive)\n * Men or confirmed postmenopausal women (by medical report verification and defined as exhibiting natural amenorrhea for at least 12 months before screening or as exhibiting natural amenorrhea for at least 6 months before screening with documented serum follicle-stimulating hormone levels >40 mIU/mL, provided that no prior hormonal treatment has taken place) or women without childbearing potential based on surgical treatment at least 6 weeks before screening such as bilateral tubal ligation, bilateral oophorectomy or hysterectomy (documented by medical report verification).\n * Subjects with renal impairment:\n\neGFR <90 mL/min/1.73 m*2 determined from serum creatinine 2 -10 days prior to dosing.\n\nStable renal disease, i.e. a serum creatinine value determined at least 3 months before the pre-study visit (e.g. during routine diagnostics) should not vary by more than 20% from the serum creatinine value determined at the pre-study visit\n\n- Healthy subjects eGFR â‰¥90 mL/min/1.73 m*2 determined from serum creatinine 2 -10 days prior to dosing.\n\nNeeds to be within the required age and body weight range of Group 1 (which should not vary by more than+- 10 years and +-10 kg to Groups 2-4).\n\n","\n\n * Clinically relevant findings(e.g. blood pressure, electrocardiogram, ECG; physical examination,laboratory examination)\n * Relevant impairment in liver function.\n * Pre-existing diseases (including impairment of liver function) for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal.\n * Any organ transplant < 1 year before participation in this study.\n * Subject under dialysis or planned to start dialysis during participation in the study.\n * Failure of any other major organ system other than the kidney.","EGFR","epidermal growth factor receptor","Protein","Ovary, Breast, Lung","Actual","2018-01-18","Actual","Anticipated","2018-11-21","Anticipated","2018-03-01","2018-01-11","2018-01-11","2018-03-28","No",null,"Interventional","Other","Single Group Assignment","None (Open Label)","Non-Randomized","18 Years","79 Years","All",null,"Yes",{"$nulls":4},"No","No",{"$nulls":17},"2017-003301-17","EudraCT Number","Area under the concentration vs. time curve from zero to infinity after single (first) dose (AUC) of BAY1142524|Maximum observed drug concentration in measured matrix after single dose administration (Cmax) of BAY1142524|AUC of unbound drug (AUCu) of BAY1142524|Cmax of unbound drug (Cmax,u) of BAY1142524","AUC(0-tlast) will be used if mean AUC(tlast âˆž) >20% of AUC)|Pre-dose,0.25,0.5,0.75,1,1.5,2,3,4,6,8,10,12,15,24,36,48,96hours post dose|AUC (0-tlast) u will be used if mean AUC (tlast âˆž) >20% of AUC). An additional blood sample for fu will be collected at 2 hours after dosing.|An additional blood sample for fu will be collected at 2 hours after dosing.","Pre-dose,0.25,0.5,0.75,1,1.5,2,3,4,6,8,10,12,15,24,36,48,96hours post dose","Number of subject with treatment emergent adverse events (TEAEs) as a measure of safety and tolerability","up to 10 days after dosing",null,"clinical-trials-contact@bayer.com","Bayer Clinical Trials Contact","(+) 1-888-8422937","Kiel, Schleswig-Holstein, Germany, 24105",null,"Germany","Schleswig-Holstein Crs Clinical-Research-Services Kiel Gmbh",{"$nulls":3},"Bayer Study Director","2018-03-28","2020-05-25T16:37:23.621","2020-05-26T17:10:42.972","NCT03402438"]
["5ecbf44311702c1b1b916ab6","NCT03402438","2018-06-14","Bayer","BAYN","Recruiting","Renal Impairment Study","Bay-1142524","Chymase Inhibitor","Yes","['Bay-1142524']","Yes","['Chymase Inhibitor']","Phase 1",4,45,"Anticipated","2018-02-12","2018-10-19","AUC","Area Under The Curve",{"$nulls":3},"The study will investigate the pharmacokinetics of BAY1142524 in subjects with mild to severe renal impairment compared to age; weight, and gender-matched healthy subjects.",null,"Investigation of Pharmacokinetics, Safety, and Tolerability of a Single Oral 25 mg BAY 1142524 IR Tablet Dose in Male and Female Subjects With Renal Impairment and in Age-, Gender-, and Weight-matched Healthy Subjects in a Single Center, Non-controlled, Open-label, Observational Design",18106,"Clinical Trial, Phase I","Healthy Volunteers","Healthy","Healthy","Experimental","Normal (healthy subjects)|Mildly renal impaired|Moderately renal impaired|Severely renal impaired","Healthy subjects matched for age, body weight and gender to the groups with renal impairment|Subjects with renal impairment and an estimated glomerular function rate between equal or above 60 and below 90 ml/min/1.75 m*2|Subjects with renal impairment and an estimated glomerular function rate between equal or above 30 and below 60 ml/min/1.75 m*2|Subjects with renal impairment and an estimated glomerular function rate between below 30 ml/min/1.75 m*2","Drug","Fulacimstat (BAY1142524)","single oral dose of 25 mg immediate-release tablet BAY1142524",null,"Normal (healthy subjects)|Mildly renal impaired|Moderately renal impaired|Severely renal impaired","\n\n * Body mass index (BMI): 18 to 34 kg/mÂ² (both inclusive)\n * Men or confirmed postmenopausal women (by medical report verification and defined as exhibiting natural amenorrhea for at least 12 months before screening or as exhibiting natural amenorrhea for at least 6 months before screening with documented serum follicle-stimulating hormone levels >40 mIU/mL, provided that no prior hormonal treatment has taken place) or women without childbearing potential based on surgical treatment at least 6 weeks before screening such as bilateral tubal ligation, bilateral oophorectomy or hysterectomy (documented by medical report verification).\n * Subjects with renal impairment:\n\neGFR <90 mL/min/1.73 m*2 determined from serum creatinine 2 -10 days prior to dosing.\n\nStable renal disease, i.e. a serum creatinine value determined at least 3 months before the pre-study visit (e.g. during routine diagnostics) should not vary by more than 20% from the serum creatinine value determined at the pre-study visit\n\n- Healthy subjects eGFR â‰¥90 mL/min/1.73 m*2 determined from serum creatinine 2 -10 days prior to dosing.\n\nNeeds to be within the required age and body weight range of Group 1 (which should not vary by more than+- 10 years and +-10 kg to Groups 2-4).\n\n","\n\n * Clinically relevant findings(e.g. blood pressure, electrocardiogram, ECG; physical examination,laboratory examination)\n * Relevant impairment in liver function.\n * Pre-existing diseases (including impairment of liver function) for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal.\n * Any organ transplant < 1 year before participation in this study.\n * Subject under dialysis or planned to start dialysis during participation in the study.\n * Failure of any other major organ system other than the kidney.","EGFR","epidermal growth factor receptor","Protein","Ovary, Breast, Lung","Actual","2018-01-18","Actual","Anticipated","2018-11-21","Anticipated","2018-06-01","2018-01-11","2018-01-11","2018-06-13","No",null,"Interventional","Other","Single Group Assignment","None (Open Label)","Non-Randomized","18 Years","79 Years","All",null,"Yes",{"$nulls":4},"No","No",{"$nulls":17},"2017-003301-17","EudraCT Number","Area under the concentration vs. time curve from zero to infinity after single (first) dose (AUC) of BAY1142524|Maximum observed drug concentration in measured matrix after single dose administration (Cmax) of BAY1142524|AUC of unbound drug (AUCu) of BAY1142524|Cmax of unbound drug (Cmax,u) of BAY1142524","AUC(0-tlast) will be used if mean AUC(tlast âˆž) >20% of AUC)|Pre-dose,0.25,0.5,0.75,1,1.5,2,3,4,6,8,10,12,15,24,36,48,96hours post dose|AUC (0-tlast) u will be used if mean AUC (tlast âˆž) >20% of AUC). An additional blood sample for fu will be collected at 2 hours after dosing.|An additional blood sample for fu will be collected at 2 hours after dosing.","Pre-dose,0.25,0.5,0.75,1,1.5,2,3,4,6,8,10,12,15,24,36,48,96hours post dose","Number of subject with treatment emergent adverse events (TEAEs) as a measure of safety and tolerability","up to 10 days after dosing",null,"clinical-trials-contact@bayer.com","Bayer Clinical Trials Contact","(+) 1-888-8422937","Kiel, Schleswig-Holstein, Germany, 24105",null,"Germany","Schleswig-Holstein Crs Clinical-Research-Services Kiel Gmbh",{"$nulls":3},"Bayer Study Director","2018-06-13","2020-05-25T16:37:23.507","2020-05-26T17:10:42.972","NCT03402438"]
["5ecbf444feab101b155308d9","NCT03402438","2018-09-11","Bayer","BAYN","Recruiting","Renal Impairment Study","Bay-1142524","Chymase Inhibitor","Yes","['Bay-1142524']","Yes","['Chymase Inhibitor']","Phase 1",4,45,"Anticipated","2018-02-12","2018-10-19","AUC","Area Under The Curve",{"$nulls":3},"The study will investigate the pharmacokinetics of BAY1142524 in subjects with mild to severe renal impairment compared to age; weight, and gender-matched healthy subjects.",null,"Investigation of Pharmacokinetics, Safety, and Tolerability of a Single Oral 25 mg BAY 1142524 IR Tablet Dose in Male and Female Subjects With Renal Impairment and in Age-, Gender-, and Weight-matched Healthy Subjects in a Single Center, Non-controlled, Open-label, Observational Design",18106,"Clinical Trial, Phase I","Healthy Volunteers","Healthy","Healthy","Experimental","Normal (healthy subjects)|Mildly renal impaired|Moderately renal impaired|Severely renal impaired","Healthy subjects matched for age, body weight and gender to the groups with renal impairment|Subjects with renal impairment and an estimated glomerular function rate between equal or above 60 and below 90 ml/min/1.75 m*2|Subjects with renal impairment and an estimated glomerular function rate between equal or above 30 and below 60 ml/min/1.75 m*2|Subjects with renal impairment and an estimated glomerular function rate between below 30 ml/min/1.75 m*2","Drug","Fulacimstat (BAY1142524)","single oral dose of 25 mg immediate-release tablet BAY1142524",null,"Normal (healthy subjects)|Mildly renal impaired|Moderately renal impaired|Severely renal impaired","\n\n * Body mass index (BMI): 18 to 34 kg/mÂ² (both inclusive)\n * Men or confirmed postmenopausal women (by medical report verification and defined as exhibiting natural amenorrhea for at least 12 months before screening or as exhibiting natural amenorrhea for at least 6 months before screening with documented serum follicle-stimulating hormone levels >40 mIU/mL, provided that no prior hormonal treatment has taken place) or women without childbearing potential based on surgical treatment at least 6 weeks before screening such as bilateral tubal ligation, bilateral oophorectomy or hysterectomy (documented by medical report verification).\n * Subjects with renal impairment:\n\neGFR <90 mL/min/1.73 m*2 determined from serum creatinine 2 -10 days prior to dosing.\n\nStable renal disease, i.e. a serum creatinine value determined at least 3 months before the pre-study visit (e.g. during routine diagnostics) should not vary by more than 20% from the serum creatinine value determined at the pre-study visit\n\n- Healthy subjects eGFR â‰¥90 mL/min/1.73 m*2 determined from serum creatinine 2 -10 days prior to dosing.\n\nNeeds to be within the required age and body weight range of Group 1 (which should not vary by more than+- 10 years and +-10 kg to Groups 2-4).\n\n","\n\n * Clinically relevant findings(e.g. blood pressure, electrocardiogram, ECG; physical examination,laboratory examination)\n * Relevant impairment in liver function.\n * Pre-existing diseases (including impairment of liver function) for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal.\n * Any organ transplant < 1 year before participation in this study.\n * Subject under dialysis or planned to start dialysis during participation in the study.\n * Failure of any other major organ system other than the kidney.","EGFR","epidermal growth factor receptor","Protein","Ovary, Breast, Lung","Actual","2018-01-18","Actual","Anticipated","2018-11-21","Anticipated","2018-09-01","2018-01-11","2018-01-11","2018-09-10","No",null,"Interventional","Other","Single Group Assignment","None (Open Label)","Non-Randomized","18 Years","79 Years","All",null,"Yes",{"$nulls":4},"No","No",{"$nulls":17},"2017-003301-17","EudraCT Number","Area under the concentration vs. time curve from zero to infinity after single (first) dose (AUC) of BAY1142524|Maximum observed drug concentration in measured matrix after single dose administration (Cmax) of BAY1142524|AUC of unbound drug (AUCu) of BAY1142524|Cmax of unbound drug (Cmax,u) of BAY1142524","AUC(0-tlast) will be used if mean AUC(tlast âˆž) >20% of AUC)|Pre-dose,0.25,0.5,0.75,1,1.5,2,3,4,6,8,10,12,15,24,36,48,96hours post dose|AUC (0-tlast) u will be used if mean AUC (tlast âˆž) >20% of AUC). An additional blood sample for fu will be collected at 2 hours after dosing.|An additional blood sample for fu will be collected at 2 hours after dosing.","Pre-dose,0.25,0.5,0.75,1,1.5,2,3,4,6,8,10,12,15,24,36,48,96hours post dose","Number of subject with treatment emergent adverse events (TEAEs) as a measure of safety and tolerability","up to 10 days after dosing",null,"clinical-trials-contact@bayer.com","Bayer Clinical Trials Contact","(+) 1-888-8422937","Kiel, Schleswig-Holstein, Germany, 24105",null,"Germany","Schleswig-Holstein Crs Clinical-Research-Services Kiel Gmbh",{"$nulls":3},"Bayer Study Director","2018-09-10","2020-05-25T16:37:24.061","2020-05-26T17:10:42.972","NCT03402438"]
["5ecbf444e2561b1b11905da5","NCT03402438","2018-11-19","Bayer","BAYN","Recruiting","Renal Impairment Study","Bay-1142524","Chymase Inhibitor","Yes","['Bay-1142524']","Yes","['Chymase Inhibitor']","Phase 1",4,45,"Anticipated","2018-02-12","2018-12-10","AUC","Area Under The Curve",{"$nulls":3},"The study will investigate the pharmacokinetics of BAY1142524 in subjects with mild to severe renal impairment compared to age; weight, and gender-matched healthy subjects.",null,"Investigation of Pharmacokinetics, Safety, and Tolerability of a Single Oral 25 mg BAY 1142524 IR Tablet Dose in Male and Female Subjects With Renal Impairment and in Age-, Gender-, and Weight-matched Healthy Subjects in a Single Center, Non-controlled, Open-label, Observational Design",18106,"Clinical Trial, Phase I","Healthy Volunteers","Healthy","Healthy","Experimental","Normal (healthy subjects)|Mildly renal impaired|Moderately renal impaired|Severely renal impaired","Healthy subjects matched for age, body weight and gender to the groups with renal impairment|Subjects with renal impairment and an estimated glomerular function rate between equal or above 60 and below 90 ml/min/1.75 m*2|Subjects with renal impairment and an estimated glomerular function rate between equal or above 30 and below 60 ml/min/1.75 m*2|Subjects with renal impairment and an estimated glomerular function rate between below 30 ml/min/1.75 m*2","Drug","Fulacimstat (BAY1142524)","single oral dose of 25 mg immediate-release tablet BAY1142524",null,"Normal (healthy subjects)|Mildly renal impaired|Moderately renal impaired|Severely renal impaired","\n\n * Body mass index (BMI): 18 to 34 kg/mÂ² (both inclusive)\n * Men or confirmed postmenopausal women (by medical report verification and defined as exhibiting natural amenorrhea for at least 12 months before screening or as exhibiting natural amenorrhea for at least 6 months before screening with documented serum follicle-stimulating hormone levels >40 mIU/mL, provided that no prior hormonal treatment has taken place) or women without childbearing potential based on surgical treatment at least 6 weeks before screening such as bilateral tubal ligation, bilateral oophorectomy or hysterectomy (documented by medical report verification).\n * Subjects with renal impairment:\n\neGFR <90 mL/min/1.73 m*2 determined from serum creatinine 2 -10 days prior to dosing.\n\nStable renal disease, i.e. a serum creatinine value determined at least 3 months before the pre-study visit (e.g. during routine diagnostics) should not vary by more than 20% from the serum creatinine value determined at the pre-study visit\n\n- Healthy subjects eGFR â‰¥90 mL/min/1.73 m*2 determined from serum creatinine 2 -10 days prior to dosing.\n\nNeeds to be within the required age and body weight range of Group 1 (which should not vary by more than+- 10 years and +-10 kg to Groups 2-4).\n\n","\n\n * Clinically relevant findings(e.g. blood pressure, electrocardiogram, ECG; physical examination,laboratory examination)\n * Relevant impairment in liver function.\n * Pre-existing diseases (including impairment of liver function) for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal.\n * Any organ transplant < 1 year before participation in this study.\n * Subject under dialysis or planned to start dialysis during participation in the study.\n * Failure of any other major organ system other than the kidney.","EGFR","epidermal growth factor receptor","Protein","Ovary, Breast, Lung","Actual","2018-01-18","Actual","Anticipated","2019-02-11","Anticipated","2018-11-01","2018-01-11","2018-01-11","2018-11-16","No",null,"Interventional","Other","Single Group Assignment","None (Open Label)","Non-Randomized","18 Years","79 Years","All",null,"Yes",{"$nulls":4},"No","No",{"$nulls":17},"2017-003301-17","EudraCT Number","Area under the concentration vs. time curve from zero to infinity after single (first) dose (AUC) of BAY1142524|Maximum observed drug concentration in measured matrix after single dose administration (Cmax) of BAY1142524|AUC of unbound drug (AUCu) of BAY1142524|Cmax of unbound drug (Cmax,u) of BAY1142524","AUC(0-tlast) will be used if mean AUC(tlast âˆž) >20% of AUC)|Pre-dose,0.25,0.5,0.75,1,1.5,2,3,4,6,8,10,12,15,24,36,48,96hours post dose|AUC (0-tlast) u will be used if mean AUC (tlast âˆž) >20% of AUC). An additional blood sample for fu will be collected at 2 hours after dosing.|An additional blood sample for fu will be collected at 2 hours after dosing.","Pre-dose,0.25,0.5,0.75,1,1.5,2,3,4,6,8,10,12,15,24,36,48,96hours post dose","Number of subject with treatment emergent adverse events (TEAEs) as a measure of safety and tolerability","up to 10 days after dosing",null,"clinical-trials-contact@bayer.com","Bayer Clinical Trials Contact","(+) 1-888-8422937","Kiel, Schleswig-Holstein, Germany, 24105",null,"Germany","Schleswig-Holstein Crs Clinical-Research-Services Kiel Gmbh",{"$nulls":3},"Bayer Study Director","2018-11-16","2020-05-25T16:37:24.584","2020-05-26T17:10:42.972","NCT03402438"]
["5ecbf44411702c1b1b916ab8","NCT03402438","2019-02-20","Bayer","BAYN","Active, not recruiting","Renal Impairment Study","Bay-1142524","Chymase Inhibitor","Yes","['Bay-1142524']","Yes","['Chymase Inhibitor']","Phase 1",4,36,"Actual","2018-02-12","2018-12-04","AUC","Area Under The Curve",{"$nulls":3},"The study will investigate the pharmacokinetics of BAY1142524 in subjects with mild to severe renal impairment compared to age; weight, and gender-matched healthy subjects.",null,"Investigation of Pharmacokinetics, Safety, and Tolerability of a Single Oral 25 mg BAY 1142524 IR Tablet Dose in Male and Female Subjects With Renal Impairment and in Age-, Gender-, and Weight-matched Healthy Subjects in a Single Center, Non-controlled, Open-label, Observational Design",18106,"Clinical Trial, Phase I","Healthy Volunteers","Healthy","Healthy","Experimental","Normal (healthy subjects)|Mildly renal impaired|Moderately renal impaired|Severely renal impaired","Healthy subjects matched for age, body weight and gender to the groups with renal impairment|Subjects with renal impairment and an estimated glomerular function rate between equal or above 60 and below 90 ml/min/1.75 m*2|Subjects with renal impairment and an estimated glomerular function rate between equal or above 30 and below 60 ml/min/1.75 m*2|Subjects with renal impairment and an estimated glomerular function rate between below 30 ml/min/1.75 m*2","Drug","Fulacimstat (BAY1142524)","single oral dose of 25 mg immediate-release tablet BAY1142524",null,"Normal (healthy subjects)|Mildly renal impaired|Moderately renal impaired|Severely renal impaired","\n\n * Body mass index (BMI): 18 to 34 kg/mÂ² (both inclusive)\n * Men or confirmed postmenopausal women (by medical report verification and defined as exhibiting natural amenorrhea for at least 12 months before screening or as exhibiting natural amenorrhea for at least 6 months before screening with documented serum follicle-stimulating hormone levels >40 mIU/mL, provided that no prior hormonal treatment has taken place) or women without childbearing potential based on surgical treatment at least 6 weeks before screening such as bilateral tubal ligation, bilateral oophorectomy or hysterectomy (documented by medical report verification).\n * Subjects with renal impairment:\n\neGFR <90 mL/min/1.73 m*2 determined from serum creatinine 2 -10 days prior to dosing.\n\nStable renal disease, i.e. a serum creatinine value determined at least 3 months before the pre-study visit (e.g. during routine diagnostics) should not vary by more than 20% from the serum creatinine value determined at the pre-study visit\n\n- Healthy subjects eGFR â‰¥90 mL/min/1.73 m*2 determined from serum creatinine 2 -10 days prior to dosing.\n\nNeeds to be within the required age and body weight range of Group 1 (which should not vary by more than+- 10 years and +-10 kg to Groups 2-4).\n\n","\n\n * Clinically relevant findings(e.g. blood pressure, electrocardiogram, ECG; physical examination,laboratory examination)\n * Relevant impairment in liver function.\n * Pre-existing diseases (including impairment of liver function) for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal.\n * Any organ transplant < 1 year before participation in this study.\n * Subject under dialysis or planned to start dialysis during participation in the study.\n * Failure of any other major organ system other than the kidney.","EGFR","epidermal growth factor receptor","Protein","Ovary, Breast, Lung","Actual","2018-01-18","Actual","Actual","2019-02-11","Anticipated","2019-02-01","2018-01-11","2018-01-11","2019-02-19","No",null,"Interventional","Other","Single Group Assignment","None (Open Label)","Non-Randomized","18 Years","79 Years","All",null,"Yes",{"$nulls":4},"No","No",{"$nulls":17},"2017-003301-17","EudraCT Number","Area under the concentration vs. time curve from zero to infinity after single (first) dose (AUC) of BAY1142524|Maximum observed drug concentration in measured matrix after single dose administration (Cmax) of BAY1142524|AUC of unbound drug (AUCu) of BAY1142524|Cmax of unbound drug (Cmax,u) of BAY1142524","AUC(0-tlast) will be used if mean AUC(tlast âˆž) >20% of AUC)|Pre-dose,0.25,0.5,0.75,1,1.5,2,3,4,6,8,10,12,15,24,36,48,96hours post dose|AUC (0-tlast) u will be used if mean AUC (tlast âˆž) >20% of AUC). An additional blood sample for fu will be collected at 2 hours after dosing.|An additional blood sample for fu will be collected at 2 hours after dosing.","Pre-dose,0.25,0.5,0.75,1,1.5,2,3,4,6,8,10,12,15,24,36,48,96hours post dose","Number of subject with treatment emergent adverse events (TEAEs) as a measure of safety and tolerability","up to 10 days after dosing",{"$nulls":4},"Kiel, Schleswig-Holstein, Germany, 24105",null,"Germany","Schleswig-Holstein Crs Clinical-Research-Services Kiel Gmbh",{"$nulls":3},"Bayer Study Director","2019-02-19","2020-05-25T16:37:24.509","2020-05-26T17:10:42.972","NCT03402438"]
["5ecbf444307e3d1b1f8d9d39","NCT03402438","2020-03-16","Bayer","BAYN","Completed","Renal Impairment Study","Bay-1142524","Chymase Inhibitor","Yes","['Bay-1142524']","Yes","['Chymase Inhibitor']","Phase 1",4,36,"Actual","2018-02-12","2018-12-04","AUC","Area Under The Curve",{"$nulls":3},"The study will investigate the pharmacokinetics of BAY1142524 in subjects with mild to severe renal impairment compared to age; weight, and gender-matched healthy subjects.",null,"Investigation of Pharmacokinetics, Safety, and Tolerability of a Single Oral 25 mg BAY 1142524 IR Tablet Dose in Male and Female Subjects With Renal Impairment and in Age-, Gender-, and Weight-matched Healthy Subjects in a Single Center, Non-controlled, Open-label, Observational Design",18106,"Clinical Trial, Phase I","Healthy Volunteers","Healthy","Healthy","Experimental","Normal (healthy subjects)|Mildly renal impaired|Moderately renal impaired|Severely renal impaired","Healthy subjects matched for age, body weight and gender to the groups with renal impairment|Subjects with renal impairment and an estimated glomerular function rate between equal or above 60 and below 90 ml/min/1.75 m*2|Subjects with renal impairment and an estimated glomerular function rate between equal or above 30 and below 60 ml/min/1.75 m*2|Subjects with renal impairment and an estimated glomerular function rate between below 30 ml/min/1.75 m*2","Drug","Fulacimstat (BAY1142524)","single oral dose of 25 mg immediate-release tablet BAY1142524",null,"Normal (healthy subjects)|Mildly renal impaired|Moderately renal impaired|Severely renal impaired","\n\n * Body mass index (BMI): 18 to 34 kg/mÂ² (both inclusive)\n * Men or confirmed postmenopausal women (by medical report verification and defined as exhibiting natural amenorrhea for at least 12 months before screening or as exhibiting natural amenorrhea for at least 6 months before screening with documented serum follicle-stimulating hormone levels >40 mIU/mL, provided that no prior hormonal treatment has taken place) or women without childbearing potential based on surgical treatment at least 6 weeks before screening such as bilateral tubal ligation, bilateral oophorectomy or hysterectomy (documented by medical report verification).\n * Subjects with renal impairment:\n\neGFR <90 mL/min/1.73 m*2 determined from serum creatinine 2 -10 days prior to dosing.\n\nStable renal disease, i.e. a serum creatinine value determined at least 3 months before the pre-study visit (e.g. during routine diagnostics) should not vary by more than 20% from the serum creatinine value determined at the pre-study visit\n\n- Healthy subjects eGFR â‰¥90 mL/min/1.73 m*2 determined from serum creatinine 2 -10 days prior to dosing.\n\nNeeds to be within the required age and body weight range of Group 1 (which should not vary by more than+- 10 years and +-10 kg to Groups 2-4).\n\n","\n\n * Clinically relevant findings(e.g. blood pressure, electrocardiogram, ECG; physical examination,laboratory examination)\n * Relevant impairment in liver function.\n * Pre-existing diseases (including impairment of liver function) for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal.\n * Any organ transplant < 1 year before participation in this study.\n * Subject under dialysis or planned to start dialysis during participation in the study.\n * Failure of any other major organ system other than the kidney.","EGFR","epidermal growth factor receptor","Protein","Ovary, Breast, Lung","Actual","2018-01-18","Actual","Actual","2019-03-19","Actual","2020-03-01","2018-01-11","2018-01-11","2020-03-13","No",null,"Interventional","Other","Single Group Assignment","None (Open Label)","Non-Randomized","18 Years","79 Years","All",null,"Yes",null,null,"URL: https://clinicaltrials.bayer.com/ [https://clinicaltrials.bayer.com/] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: Click here to find results for studies related to Bayer products.",null,"No","No",{"$nulls":17},"2017-003301-17","EudraCT Number","Area under the concentration vs. time curve from zero to infinity after single (first) dose (AUC) of BAY1142524|Maximum observed drug concentration in measured matrix after single dose administration (Cmax) of BAY1142524|AUC of unbound drug (AUCu) of BAY1142524|Cmax of unbound drug (Cmax,u) of BAY1142524","AUC(0-tlast) will be used if mean AUC(tlast âˆž) >20% of AUC)|Pre-dose,0.25,0.5,0.75,1,1.5,2,3,4,6,8,10,12,15,24,36,48,96hours post dose|AUC (0-tlast) u will be used if mean AUC (tlast âˆž) >20% of AUC). An additional blood sample for fu will be collected at 2 hours after dosing.|An additional blood sample for fu will be collected at 2 hours after dosing.","Pre-dose,0.25,0.5,0.75,1,1.5,2,3,4,6,8,10,12,15,24,36,48,96hours post dose","Number of subject with treatment emergent adverse events (TEAEs) as a measure of safety and tolerability","up to 10 days after dosing",{"$nulls":4},"Kiel, Schleswig-Holstein, Germany, 24105",null,"Germany","Schleswig-Holstein Crs Clinical-Research-Services Kiel Gmbh",{"$nulls":3},"Bayer Study Director","2020-03-13","2020-05-25T16:37:24.575","2020-05-26T17:10:42.972","NCT03402438"]
["5ecbf447feab101b155308e2","NCT03403205","2019-05-01","Alexion","ALXN","Recruiting","Efficacy and Safety of ALXN1840 (Formerly Named WTX101) Administered for 48 Weeks Versus Standard of Care in Patients With Wilson Disease With an Extension Period of up to 60 Months","Wtx-101",null,"Yes","['Wtx-101']","Unknown",null,"Phase 3",2,180,"Anticipated","2018-02-15","2021-02-01",{"$nulls":5},"The purpose of this study is to evaluate the efficacy of ALXN1840 (formerly called WTX101) administered for 48 weeks compared to standard of care (SoC) in WD patients aged 12 and older.",null,"A Phase 3, Randomized, Rater-Blinded, Multi-Center Study To Evaluate the Efficacy and Safety of ALXN1840 Administered For 48 Weeks Versus Standard of Care in Patients With Wilson Disease Aged 12 Years and Older With an Extension Period of Up To 60 Months","WTX101-301","Wilson Disease","Other","Other","Other","Experimental|Active Comparator","ALXN1840 15-60 mg|Standard of Care (SoC) Medication",null,"Drug","ALXN1840|SoC Therapy","ALXN1840 administered orally in 15 mg tablets|Depending on the site/region,subjects randomized to receive SoC treatment will receive trientine, penicillamine, Zinc, or a combination of these medicines, administered according to standard regimens.","Formerly named WTX101","ALXN1840 15-60 mg|Standard of Care (SoC) Medication",{"$nulls":6},"Actual","2018-01-18","Actual","Anticipated","2026-02-01","Anticipated","2019-04-01","2017-12-19","2018-01-10","2019-04-29","Yes",null,"Interventional","Treatment","Parallel Assignment","Single (Outcomes Assessor)","Randomized","12 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":19},"Evaluate the efficacy of ALXN1840 using standard of care as comparator and copper as the control assessed in terms of the percentage change from baseline (Day 1) to 48 weeks in non-ceruloplasmin-bound copper levels","Change from baseline (Day 1) to 48 weeks",null,"Safety and tolerability of individualized dosing of ALXN1840 by descriptive statistics|Effects of ALXN1840 on hepatic status|Effects of ALXN1840 on disability status|Effects of ALXN1840 on neurological status|Global effects of ALXN1840 on clinical symptoms as assessed by the Investigator on the Clinical Global Impression-Improvement Scale (CGI-I) and the Clinical Global Impression-Severity Scale (CGI-S)|Effects of ALXN1840 on NCC responder rate","Change from baseline (Day 1) to 48 weeks",null,"clinicaltrials@alexion.com","Alexion Pharmaceuticals, Inc.",{"$f":"1-855-752-2356","v":-3962},"Graz, Austria, 8036 Medical University InnsbruckInnsbruck, Austria, 6020 Medizinische Universitat Wien, Innere Medizin IiiVienna, Austria, 1090|Prague, Czechia|Bron, France, 69677 Hopital LariboisiereParis, France, 75010|Dresden, Germany, 01307 Ifi - Studien Und Projekte GmbhHamburg, Germany, 20099 University Hospital HeidelbergHeidelberg, Germany, 69120 University Hospital LeipzigLeipzig, Germany, 04103|Budapest, Hungary, 1085|Jerusalem, Israel, Q47X+Xq Sheba Medical CenterRamat Gan, Israel, 2Rwv+M4|Warsaw, Poland, 02-957|Barcelona, Spain, H446+P9 Hospital Universitario Puerta De Hierro MajadahondaMadrid, Spain, 28222|Birmingham, England, United Kingdom, B15 2Th Cambridge University - Addenbrooke'S HospitalCambridge, England, United Kingdom, Cb2 0Qq Royal Surrey County HospitalGuildford, England, United Kingdom, Gu2 7Xx|Los Angeles, California, United States, 90095|New Haven, Connecticut, United States, 06510|Chicago, Illinois, United States, 60611|Ann Arbor, Michigan, United States, 48109|Nashville, Tennessee, United States, 37232|Houston, Texas, United States, 77030|Seattle, Washington, United States, 98105","California|Connecticut|Illinois|Michigan|Tennessee|Texas|Washington","Austria|Czechia|France|Germany|Hungary|Israel|Poland|Spain|United Kingdom|United States","Medical University Graz|Vseobecna Fakultni Nemocnice V Praze|Chu Lyon- Hopital Femme- Mere-Enfant|University Hospital Carl Gustav Carus Dresden|Semmelweis University|Hadassah University Hospital|Instytut Psychiatrii I Neurologii|Hospital Parc Tauli De Sabadell|, England Queen Elizabeth Hospital Birmingham|University Of California, Los Angeles (Ucla) - David Geffen School Of Medicine|Yale University School Of Medicine|Northwestern Memorial Hospital|University Of Michigan|Vanderbilt University Medical Center|Baylor College Of Medicine|Seattle Children's Hospital",{"$nulls":3},"Eugene Swenson, MD, PhD","2019-04-29","2020-05-25T16:37:27.517","2020-05-26T17:10:42.972","NCT03403205"]
["5ecbf448fe30261b1a0482b2","NCT03403205","2019-11-01","Alexion","ALXN","Recruiting","Efficacy and Safety of ALXN1840 (Formerly Named WTX101) Administered for 48 Weeks Versus Standard of Care in Patients With Wilson Disease With an Extension Period of up to 60 Months","Wtx-101",null,"Yes","['Wtx-101']","Unknown",null,"Phase 3",2,180,"Anticipated","2018-02-15","2021-02-01",{"$nulls":5},"The purpose of this study is to evaluate the efficacy of ALXN1840 (formerly called WTX101) administered for 48 weeks compared to standard of care (SoC) in WD patients aged 12 and older.",null,"A Phase 3, Randomized, Rater-Blinded, Multi-Center Study To Evaluate the Efficacy and Safety of ALXN1840 Administered For 48 Weeks Versus Standard of Care in Patients With Wilson Disease Aged 12 Years and Older With an Extension Period of Up To 60 Months","WTX101-301","Wilson Disease","Other","Other","Other","Experimental|Active Comparator","ALXN1840 15-60 mg|Standard of Care (SoC) Medication",null,"Drug","ALXN1840|SoC Therapy","ALXN1840 administered orally in 15 mg tablets|Depending on the site/region,subjects randomized to receive SoC treatment will receive trientine, penicillamine, Zinc, or a combination of these medicines, administered according to standard regimens.","Formerly named WTX101","ALXN1840 15-60 mg|Standard of Care (SoC) Medication",{"$nulls":6},"Actual","2018-01-18","Actual","Anticipated","2026-02-01","Anticipated","2019-10-01","2017-12-19","2018-01-10","2019-10-30","Yes",null,"Interventional","Treatment","Parallel Assignment","Single (Outcomes Assessor)","Randomized","12 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":19},"Evaluate the efficacy of ALXN1840 using standard of care as comparator and copper as the control assessed in terms of the percentage change from baseline (Day 1) to 48 weeks in non-ceruloplasmin-bound copper levels","Change from baseline (Day 1) to 48 weeks",null,"Safety and tolerability of individualized dosing of ALXN1840 by descriptive statistics|Effects of ALXN1840 on hepatic status|Effects of ALXN1840 on disability status|Effects of ALXN1840 on neurological status|Global effects of ALXN1840 on clinical symptoms as assessed by the Investigator on the Clinical Global Impression-Improvement Scale (CGI-I) and the Clinical Global Impression-Severity Scale (CGI-S)|Effects of ALXN1840 on NCC responder rate","Change from baseline (Day 1) to 48 weeks",null,"clinicaltrials@alexion.com","Alexion Pharmaceuticals, Inc.",-3962,"Camperdown, New South Wales, Australia, 2050|Adelaide, South|Heidelberg, Victoria, Australia, 3084 Alfred HospitalMelbourne, Victoria, Australia, 3004 Royal Melbourne HospitalParkville, Victoria, Australia, 3050|Graz, Austria, 8036 Medical University InnsbruckInnsbruck, Austria, 6020 Medizinische Universitat Wien, Innere Medizin IiiVienna, Austria, 1090|Prague, Czechia|Bron, France, 69677 Hopital LariboisiereParis, France, 75010|Dresden, Germany, 01307 Ifi - Studien Und Projekte GmbhHamburg, Germany, 20099 University Hospital HeidelbergHeidelberg, Germany, 69120 University Hospital LeipzigLeipzig, Germany, 04103|Budapest, Hungary, 1085|Haifa, Israel, 3436212 Hadassah University HospitalJerusalem, Israel, Q47X+Xq Sheba Medical CenterRamat Gan, Israel, 2Rwv+M4|Matsuyama, Ehime, Japan|Kurume, Fukuoka, Japan|Sapporo, Hokkaido, Japan|Kumamoto, Japan Osaka Medical College HospitalOsaka, Japan Toho University Ohashi Medical CenterTokyo, Japan|Warsaw, Poland, 02-957 Russian Federation National Scientific Institute Of NutritionMoscow, Russian Federation, 115446 Privolzhsky Research Medical University Of The Ministry Of Healthcare Of The Russian FederationNizhny Novgorod, Russian Federation, 603005 St. Petersburg Clinical Hospital Of The Russian Academy Of SciencesSaint Petersburg, Russian Federation, 194021|Belgrade, Serbia, 11000 Clinic For Gastroenterohepatology, Clinical Center Of|Barcelona,, Spain, 08035 Hospital ClÃ­nic I Provincial De BarcelonaBarcelona, Spain, 08036 Hospital Parc Tauli De SabadellBarcelona, Spain, H446+P9 Hospital Universitario Puerta De Hierro MajadahondaMadrid, Spain, 28222|Birmingham, England, United Kingdom, B15 2Th Cambridge University - Addenbrooke'S HospitalCambridge, England, United Kingdom, Cb2 0Qq Royal Surrey County HospitalGuildford, England, United Kingdom, Gu2 7Xx|Los Angeles, California, United States, 90095|New Haven, Connecticut, United States, 06510|Chicago, Illinois, United States, 60611|Ann Arbor, Michigan, United States, 48109|Nashville, Tennessee, United States, 37232|Houston, Texas, United States, 77030|Seattle, Washington, United States, 98105","California|Connecticut|Illinois|Michigan|Tennessee|Texas|Washington","Australia|Austria|Czechia|France|Germany|Hungary|Israel|Japan|Poland|Serbia|Spain|United Kingdom|United States","New South Wales Royal Prince Alfred Hospital|Royal Adelaide Hospital|Victoria Austin Health|Medical University Graz|Vseobecna Fakultni Nemocnice V Praze|Chu Lyon- Hopital Femme- Mere-Enfant|University Hospital Carl Gustav Carus Dresden|Semmelweis University|Carmel Medical Center|Ehime Ehime Prefectural Central Hospital|Fukuoka Kurume University Hospital|Hokkaido Hokkaido Medical Center|Kumamoto University Hospital|Instytut Psychiatrii I Neurologii|Children Hospital In Belgrade|Hospital Universitari Vall D'Hebron|, England Queen Elizabeth Hospital Birmingham|University Of California, Los Angeles (Ucla) - David Geffen School Of Medicine|Yale University School Of Medicine|Northwestern Memorial Hospital|University Of Michigan|Vanderbilt University Medical Center|Baylor College Of Medicine|Seattle Children's Hospital",{"$nulls":3},"Eugene Swenson, MD, PhD","2019-10-30","2020-05-25T16:37:28.204","2020-05-26T17:10:42.972","NCT03403205"]
["5ecbf448307e3d1b1f8d9d42","NCT03403205","2020-02-26","Alexion","ALXN","Recruiting","Efficacy and Safety of ALXN1840 (Formerly Named WTX101) Administered for 48 Weeks Versus Standard of Care in Patients With Wilson Disease With an Extension Period of up to 60 Months","Wtx-101",null,"Yes","['Wtx-101']","Unknown",null,"Phase 3",2,180,"Anticipated","2018-02-15","2021-02-01",{"$nulls":5},"The purpose of this study is to evaluate the efficacy of ALXN1840 (formerly called WTX101) administered for 48 weeks compared to standard of care (SoC) in WD patients aged 12 and older.",null,"A Phase 3, Randomized, Rater-Blinded, Multi-Center Study To Evaluate the Efficacy and Safety of ALXN1840 Administered For 48 Weeks Versus Standard of Care in Patients With Wilson Disease Aged 12 Years and Older With an Extension Period of Up To 60 Months","WTX101-301","Wilson Disease","Other","Other","Other","Experimental|Active Comparator","ALXN1840 15-60 mg|Standard of Care (SoC) Medication",null,"Drug","ALXN1840|SoC Therapy","ALXN1840 administered orally in 15 mg tablets|Depending on the site/region,subjects randomized to receive SoC treatment will receive trientine, penicillamine, Zinc, or a combination of these medicines, administered according to standard regimens.","Formerly named WTX101","ALXN1840 15-60 mg|Standard of Care (SoC) Medication",{"$nulls":6},"Actual","2018-01-18","Actual","Anticipated","2026-02-01","Anticipated","2020-01-01","2017-12-19","2018-01-10","2020-02-24","Yes",null,"Interventional","Treatment","Parallel Assignment","Single (Outcomes Assessor)","Randomized","12 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":19},"Evaluate the efficacy of ALXN1840 using standard of care as comparator and copper as the control assessed in terms of the percentage change from baseline (Day 1) to 48 weeks in non-ceruloplasmin-bound copper levels","Change from baseline (Day 1) to 48 weeks",null,"Safety and tolerability of individualized dosing of ALXN1840 by descriptive statistics|Effects of ALXN1840 on hepatic status|Effects of ALXN1840 on disability status|Effects of ALXN1840 on neurological status|Global effects of ALXN1840 on clinical symptoms as assessed by the Investigator on the Clinical Global Impression-Improvement Scale (CGI-I) and the Clinical Global Impression-Severity Scale (CGI-S)|Effects of ALXN1840 on NCC responder rate","Change from baseline (Day 1) to 48 weeks",null,"clinicaltrials@alexion.com","Alexion Pharmaceuticals, Inc.",-3962,"Concord, Australia, Nsw 2139|Camperdown, New South Wales, Australia, 2050|Adelaide, South|Nedlands, Western|Heidelberg, Victoria, Australia, 3084 Alfred HospitalMelbourne, Victoria, Australia, 3004 Royal Melbourne HospitalParkville, Victoria, Australia, 3050 The Royal Children'S Hospital, Melbourne: Gastroenterology And Clinical NutritionParkville, Victoria, Australia, 3052|Graz, Austria, 8036 Medical University InnsbruckInnsbruck, Austria, 6020 Medizinische Universitat Wien, Innere Medizin IiiVienna, Austria, 1090|Gent, Oost-Vlaanderen, Belgium, B-9000|Leuven, Belgium, 3000|Toronto, Ontario, Canada, M5G 2C4|Prague, Czechia|Aarhus, Denmark, 8200|Bron, France, 69677 Hopital LariboisiereParis, France, 75010 Centre Hospitalier Universitaire (Chu) De Toulouse - Hopital Pierre-Paul RiquetToulouse, France, 31059|Dresden, Germany, 01307 Ifi - Studien Und Projekte GmbhHamburg, Germany, 20099 University Hospital HeidelbergHeidelberg, Germany, 69120 University Hospital LeipzigLeipzig, Germany, 04103 Hong Kong Queen Mary HospitalHong Kong, Hong Kong, 852|Budapest, Hungary, 1085|Haifa, Israel, 3436212 Hadassah University HospitalJerusalem, Israel, Q47X+Xq Sheba Medical CenterRamat Gan, Israel, 2Rwv+M4|Chiba, Japan Kumamoto University HospitalKumamoto, Japan Osaka Medical College HospitalOsaka, Japan Toho University Ohashi Medical CenterTokyo, Japan Korea, Republic Of Kyungpook National University Children'S HospitalDaegu, Korea, Republic Of, 41944 Asan Medical CenterSeoul, Korea, Republic Of, 05505 Seoul National UniversitySeoul, Korea, Republic Of|Matsuyama, Ehime, Japan|Kurume, Fukuoka, Japan|Sapporo, Hokkaido, Japan|Yokohama, Kanagawa, Japan|Auckland, New Zealand, 1023|Warsaw, Poland, 02-957 Russian Federation National Scientific Institute Of NutritionMoscow, Russian Federation, 115446 Federal State Autonomous Institution \"National Medical Research Center Of Children'S Health\" Of The Ministry Of Health Of The Russian FederationMoscow, Russian Federation, 119991 University Clinic Hospital Number 2, Federal State Autonomous Institution Of Higher Education, First Moscow State Medical University N. A. I. M. Sechenov Of The Ministry Of Healthcare Of The Russian FederationMoscow, Russian Federation, 119991 University Clinic Hospital Number 3, Federal State Autonomous Institution Of Higher Education, First Moscow State Medical University N. A. I. M. Sechenov Of The Ministry Of Healthcare Of The Russian FederationMoscow, Russian Federation, 119991 Privolzhsky Research Medical University Of The Ministry Of Healthcare Of The Russian FederationNizhny Novgorod, Russian Federation, 603005 St. Petersburg Clinical Hospital Of The Russian Academy Of SciencesSaint Petersburg, Russian Federation, 194021 Federal State Budgetary Institution \"Child Research Clinical Infectious Disease Center\" Of The Medical Biology AgencySaint Petersburg, Russian Federation, 197022|Warszawa, Woj. Mazowieckie, Poland, 04-730|Belgrade, Serbia, 11000 Clinic For Gastroenterohepatology, Clinical Center Of|Esplugues De Llobregat, Bareclona, Spain, 8950|Barcelona,, Spain, 08035 Hospital Universitari Vall Hebron BarcelonaBarcelona, Spain, 08035 Hospital ClÃ­nic I Provincial De BarcelonaBarcelona, Spain, 08036 Hospital Parc Tauli De SabadellBarcelona, Spain, H446+P9 Hospital Universitario Puerta De Hierro MajadahondaMadrid, Spain, 28222 Hospital Materno Infantil De MÃ¡lagaMÃ¡laga, Spain, 29011 Taiwan Chang Gung Memorial Hospital (Cgmh) - Kaohsiung BranchKaohsiung, Taiwan, 833 National Taiwan University HospitalTaipei, Taiwan, 100 Chang Gung Memorial Hospital-Linkou BranchTaoyuan, Taiwan, 333|Las Palmas De Gran Canaria, Las Palmas, Spain, 35016|Izmir, Bornova, Turkey, 35100|Ankara, Turkey, 06620 Koc University Medical FacultyIstanbul, Turkey, 1111 Bezmialem Foundation University Medical FacultyIstanbul, Turkey, 34093 Istanbul Uni. Istanbul Medical Faculty HospitalIstanbul, Turkey, 34093|Bornova, Izmir, Turkey, 35100|Birmingham, England, United Kingdom, B15 2Th Cambridge University - Addenbrooke'S HospitalCambridge, England, United Kingdom, Cb2 0Qq Royal Surrey County HospitalGuildford, England, United Kingdom, Gu2 7Xx|Brixton, London, United Kingdom, Se5 9Rs|Los Angeles, California, United States, 90095|New Haven, Connecticut, United States, 06510|Orlando, Florida, United States, 32803|Chicago, Illinois, United States, 60611|Ann Arbor, Michigan, United States, 48109|Philadelphia, Pennsylvania, United States, 19104|Nashville, Tennessee, United States, 37232|Dallas, Texas, United States, 75390-8887 Baylor College Of MedicineHouston, Texas, United States, 77030 Texas Children'S HospitalHouston, Texas, United States, 77030|Seattle, Washington, United States, 98105","California|Connecticut|Florida|Illinois|Michigan|Pennsylvania|Tennessee|Texas|Washington","Australia|Austria|Belgium|Canada|Czechia|Denmark|France|Germany|Hungary|Israel|Japan|New Zealand|Poland|Serbia|Spain|Turkey|United Kingdom|United States","Concord Repatriation General Hospital|New South Wales Royal Prince Alfred Hospital|Royal Adelaide Hospital|Sir Charles Gairdner Hospital|Victoria Austin Health|Medical University Graz|Oost-Vlaanderen Ghent University Hospital (Universitair Ziekenhuis Gent)|University Hospitals Leuven - Gasthuisberg|Ontario Toronto General Hospital|Vseobecna Fakultni Nemocnice V Praze|Aarhus Universitetshospital|Chu Lyon- Hopital Femme- Mere-Enfant|University Hospital Carl Gustav Carus Dresden|Semmelweis University|Carmel Medical Center|Chiba Children's Hospital|Ehime Ehime Prefectural Central Hospital|Fukuoka Kurume University Hospital|Hokkaido Hokkaido Medical Center|Kanagawa Saiseikai Yokohama Tobu Hospital|Auckland City Hospital|Instytut Psychiatrii I Neurologii|Woj. Mazowieckie Instytut Pomnik Centrum Zdrowia Dziecka|Children Hospital In Belgrade|Bareclona Hospital Sant Joan De DÃ©u Barcelona|Hospital Universitari Vall D'Hebron|Las Palmas Hospital Materno-Infantil Las Palmas De Gran Canaria|Bornova Ege University School Of Medicine|Hacettepe Universitesi - Tip Fakultesi (Hacettepe University Faculty Of Medicine)|Izmir Ege Universitesi Tip Fakultesi Ã‡ocuk Hastanesi (Ege University Medical Faculty Pediatric Hospital)|, England Queen Elizabeth Hospital Birmingham|, London Kings College Hospital|University Of California, Los Angeles (Ucla) - David Geffen School Of Medicine|Yale University School Of Medicine|Adventhealth Medical Group Pediatric Gastroenterology At Orlando|Northwestern Memorial Hospital|University Of Michigan|Children's Hospital Of Philadelphia|Vanderbilt University Medical Center|Ut Southwestern Medical Center|Seattle Children's Hospital",{"$nulls":3},"Eugene Swenson, MD, PhD","2020-02-24","2020-05-25T16:37:28.149","2020-05-26T17:10:42.972","NCT03403205"]
["5ecbf44911702c1b1b916ac6","NCT03403374","2018-04-03","Amgen","AMGN","Not yet recruiting","Safety and Tolerability of Repatha in Indian Subjects With Homozygous Familial Hypercholesterolemia","Evolocumab","PCSK9 Inhibitor","No",null,"No",null,"Phase 4",1,30,"Anticipated","2018-05-28","2020-08-12",{"$nulls":5},"To describe the safety and tolerability of Repatha in subjects with homozygous familial hypercholesterolemia (HoFH) in India. All subjects will receive Repatha over an 8 week period.","An open-label, multicentre, phase 4 study to describe the safety and tolerability of Repatha in 30 Indian subjects with HoFH. Subjects who meet the inclusion/exclusion criteria and laboratory assessments at screening will be enrolled and will be required to maintain their current lipid-lowering drug therapy throughout the duration of the trial. Subjects will receive Repatha 420 mg QM SC and study visits will occur approximately every 4 weeks. Apheresis subjects will receive Repatha 420 mg SC every 2 weeks to correspond with their apheresis schedule. Final administration of Repatha (for all subjects) will occur at week 8. The end of study (EOS) visit will occur at week 12 for all subjects.","A Multicenter, Open-label, Single-arm, Study to Evaluate Safety and Tolerability of Repatha in Patients With Homozygous Familial Hypercholesterolemia (HoFH) in India",20170199,"Homozygous Familial Hypercholesterolemia HoFH","Hypercholesterolemia","Metabolic Diseases","Nutritional Disorders","Experimental","RepathaÂ® (evolocumab)","Single arm, all subjects receive Repatha administered by subcutaneous injection via autoinjector(AI)/pen","Drug","Repatha&#xAE; (evolocumab)","Administered of Repatha by subcutaneous injection via autoinjector(AI)/pen",null,"RepathaÂ® (evolocumab)","\n\n * Male or female â‰¥ 12 to â‰¤ 80 years of age at the time of signing the informed consent.\n * Diagnosis of HoFH based on LDL-C, familial history and xanthoma\n * On a low-fat diet and receiving background lipid-lowering therapy stable for 4 weeks prior to screening and during the time frame of the trial.\n * Fasting LDL-C at screening > 130 mg/dL (3.4 mmol/L)\n * Fasting triglycerides at screening â‰¤ 400 mg/dL (4.5 mmol/L)\n\n","\n\n * Use of mipomersen or lomitapide within 6 months of screening.\n * Known active infection or major hematologic, renal, metabolic, gastrointestinal, hepatic, or endocrine dysfunction.\n * Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(ies).\n * Female subject is pregnant or breastfeeding or planning to become pregnant or breastfeed\n * Female subjects of childbearing potential unwilling to use an acceptable method of effective contraception\n * Subject has known sensitivity to any of the products to be administered during dosing.\n * History or evidence of any other clinically significant disorder, condition or disease\n * Subject has previously received evolocumab or any other PCSK9-inhibiting therapy.",{"$nulls":4},"Actual","2018-01-18","Actual","Anticipated","2020-08-12","Anticipated","2018-03-01","2018-01-03","2018-01-17","2018-03-30","No","Evolocumab\nHypercholesterolemia","Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","12 Years","80 Years","All",null,"No",null,null,"URL: http://www.amgentrials.com [http://www.amgentrials.com] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: AmgenTrials clinical trials website",null,"No","No",{"$nulls":19},"Number of participants with treatment related Adverse Events","Characterize the safety and tolerability of Repatha based on an analysis of the subject incidence of treatment-emergent adverse events","12 weeks","Change in LDC-C|Change in ApoB|Change in Lp(a)","change from baseline to week 12 in low-density lipoprotein cholesterol (LDL-C)|change from baseline to week 12 apolipoprotein B (ApoB)|change from baseline to week 12 in lipoprotein(a)","Week 12|Lp(a) in HoFH patients in India","medinfo@amgen.com","Amgen Call Center","866-572-6436",{"$nulls":7},"MD","2018-03-30","2020-05-25T16:37:29.444","2020-05-26T17:10:42.972","NCT03403374"]
["5ecbf44a307e3d1b1f8d9d47","NCT03403374","2018-07-26","Amgen","AMGN","Not yet recruiting","Safety and Tolerability of Repatha in Indian Subjects With Homozygous Familial Hypercholesterolemia","Evolocumab","PCSK9 Inhibitor","No",null,"No",null,"Phase 4",1,30,"Anticipated","2018-07-25","2020-10-14",{"$nulls":5},"To describe the safety and tolerability of Repatha in subjects with homozygous familial hypercholesterolemia (HoFH) in India. All subjects will receive Repatha over an 8 week period.","An open-label, multicentre, phase 4 study to describe the safety and tolerability of Repatha in 30 Indian subjects with HoFH. Subjects who meet the inclusion/exclusion criteria and laboratory assessments at screening will be enrolled and will be required to maintain their current lipid-lowering drug therapy throughout the duration of the trial. Subjects will receive Repatha 420 mg QM SC and study visits will occur approximately every 4 weeks. Apheresis subjects will receive Repatha 420 mg SC every 2 weeks to correspond with their apheresis schedule. Final administration of Repatha (for all subjects) will occur at week 8. The end of study (EOS) visit will occur at week 12 for all subjects.","A Multicenter, Open-label, Single-arm, Study to Evaluate Safety and Tolerability of Repatha in Patients With Homozygous Familial Hypercholesterolemia (HoFH) in India",20170199,"Homozygous Familial Hypercholesterolemia HoFH","Hypercholesterolemia","Metabolic Diseases","Nutritional Disorders","Experimental","RepathaÂ® (evolocumab)","Single arm, all subjects receive Repatha administered by subcutaneous injection via autoinjector(AI)/pen","Drug","Repatha&#xAE; (evolocumab)","Administered of Repatha by subcutaneous injection via autoinjector(AI)/pen",null,"RepathaÂ® (evolocumab)","\n\n * Male or female â‰¥ 12 to â‰¤ 80 years of age at the time of signing the informed consent.\n * Diagnosis of HoFH based on LDL-C, familial history and xanthoma\n * On a low-fat diet and receiving background lipid-lowering therapy stable for 4 weeks prior to screening and during the time frame of the trial.\n * Fasting LDL-C at screening > 130 mg/dL (3.4 mmol/L)\n * Fasting triglycerides at screening â‰¤ 400 mg/dL (4.5 mmol/L)\n\n","\n\n * Use of mipomersen or lomitapide within 6 months of screening.\n * Known active infection or major hematologic, renal, metabolic, gastrointestinal, hepatic, or endocrine dysfunction.\n * Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(ies).\n * Female subject is pregnant or breastfeeding or planning to become pregnant or breastfeed\n * Female subjects of childbearing potential unwilling to use an acceptable method of effective contraception\n * Subject has known sensitivity to any of the products to be administered during dosing.\n * History or evidence of any other clinically significant disorder, condition or disease\n * Subject has previously received evolocumab or any other PCSK9-inhibiting therapy.",{"$nulls":4},"Actual","2018-01-18","Actual","Anticipated","2020-10-14","Anticipated","2018-07-01","2018-01-03","2018-01-17","2018-07-25","No","Evolocumab\nHypercholesterolemia","Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","12 Years","80 Years","All",null,"No",null,null,"URL: http://www.amgentrials.com [http://www.amgentrials.com] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: AmgenTrials clinical trials website",null,"No","No",{"$nulls":19},"Number of participants with treatment related Adverse Events","Characterize the safety and tolerability of Repatha based on an analysis of the subject incidence of treatment-emergent adverse events","12 weeks","Change in LDC-C|Change in ApoB|Change in Lp(a)","change from baseline to week 12 in low-density lipoprotein cholesterol (LDL-C)|change from baseline to week 12 apolipoprotein B (ApoB)|change from baseline to week 12 in lipoprotein(a)","Week 12|Lp(a) in HoFH patients in India","medinfo@amgen.com","Amgen Call Center","866-572-6436","Ahmedabad, Gujarat, India, 380 054|Belgaum, Karnataka, India, 590 010|Mumbai, Maharashtra, India, 400 007 Research SitePune, Maharashtra, India, 411 005 Research SitePune, Maharashtra, India, 411 006",null,"India","Gujarat Research Site|Karnataka Research Site|Maharashtra Research Site",{"$nulls":3},"MD","2018-07-25","2020-05-25T16:37:30.049","2020-05-26T17:10:42.972","NCT03403374"]
["5ecbf44ae2561b1b11905db2","NCT03403374","2018-10-12","Amgen","AMGN","Recruiting","Safety and Tolerability of Repatha in Indian Subjects With Homozygous Familial Hypercholesterolemia","Evolocumab","PCSK9 Inhibitor","No",null,"No",null,"Phase 4",1,30,"Anticipated","2018-08-04","2020-10-25",{"$nulls":5},"To describe the safety and tolerability of Repatha in subjects with homozygous familial hypercholesterolemia (HoFH) in India. All subjects will receive Repatha over an 8 week period.","An open-label, multicentre, phase 4 study to describe the safety and tolerability of Repatha in 30 Indian subjects with HoFH. Subjects who meet the inclusion/exclusion criteria and laboratory assessments at screening will be enrolled and will be required to maintain their current lipid-lowering drug therapy throughout the duration of the trial. Subjects will receive Repatha 420 mg QM SC and study visits will occur approximately every 4 weeks. Apheresis subjects will receive Repatha 420 mg SC every 2 weeks to correspond with their apheresis schedule. Final administration of Repatha (for all subjects) will occur at week 8. The end of study (EOS) visit will occur at week 12 for all subjects.","A Multicenter, Open-label, Single-arm, Study to Evaluate Safety and Tolerability of Repatha in Patients With Homozygous Familial Hypercholesterolemia (HoFH) in India",20170199,"Homozygous Familial Hypercholesterolemia HoFH","Hypercholesterolemia","Metabolic Diseases","Nutritional Disorders","Experimental","RepathaÂ® (evolocumab)","Single arm, all subjects receive Repatha administered by subcutaneous injection via autoinjector(AI)/pen","Drug","Repatha&#xAE; (evolocumab)","Administered of Repatha by subcutaneous injection via autoinjector(AI)/pen",null,"RepathaÂ® (evolocumab)","\n\n * Male or female â‰¥ 12 to â‰¤ 80 years of age at the time of signing the informed consent.\n * Diagnosis of HoFH based on LDL-C, familial history and xanthoma\n * On a low-fat diet and receiving background lipid-lowering therapy stable for 4 weeks prior to screening and during the time frame of the trial.\n * Fasting LDL-C at screening > 130 mg/dL (3.4 mmol/L)\n * Fasting triglycerides at screening â‰¤ 400 mg/dL (4.5 mmol/L)\n\n","\n\n * Use of mipomersen or lomitapide within 6 months of screening.\n * Known active infection or major hematologic, renal, metabolic, gastrointestinal, hepatic, or endocrine dysfunction.\n * Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(ies).\n * Female subject is pregnant or breastfeeding or planning to become pregnant or breastfeed\n * Female subjects of childbearing potential unwilling to use an acceptable method of effective contraception\n * Subject has known sensitivity to any of the products to be administered during dosing.\n * History or evidence of any other clinically significant disorder, condition or disease\n * Subject has previously received evolocumab or any other PCSK9-inhibiting therapy.",{"$nulls":4},"Actual","2018-01-18","Actual","Anticipated","2020-10-25","Anticipated","2018-10-01","2018-01-03","2018-01-17","2018-10-10","No","Evolocumab\nHypercholesterolemia","Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","12 Years","80 Years","All",null,"No","Yes\nDe-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request",null,"URL: http://www.amgentrials.com [http://www.amgentrials.com] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: AmgenTrials clinical trials website",null,"No","No",{"$nulls":19},"Number of participants with treatment related Adverse Events","Characterize the safety and tolerability of Repatha based on an analysis of the subject incidence of treatment-emergent adverse events","12 weeks","Change in LDC-C|Change in ApoB|Change in Lp(a)","change from baseline to week 12 in low-density lipoprotein cholesterol (LDL-C)|change from baseline to week 12 apolipoprotein B (ApoB)|change from baseline to week 12 in lipoprotein(a)","Week 12|Lp(a) in HoFH patients in India","medinfo@amgen.com","Amgen Call Center","866-572-6436","New Delhi, Delhi, India, 110 002 Research SiteNew Delhi, Delhi, India, 110 029|Ahmedabad, Gujarat, India, 380 054|Bangalore, Karnataka, India, 560 017 Research SiteBelgaum, Karnataka, India, 590 010|Mumbai, Maharashtra, India, 400 007 Research SitePune, Maharashtra, India, 411 005 Research SitePune, Maharashtra, India, 411 006",null,"India","Delhi Research Site|Gujarat Research Site|Karnataka Research Site|Maharashtra Research Site",{"$nulls":3},"MD","2018-10-10","2020-05-25T16:37:30.173","2020-05-26T17:10:42.972","NCT03403374"]
["5ecbf44a307e3d1b1f8d9d48","NCT03403374","2018-12-19","Amgen","AMGN","Recruiting","Safety and Tolerability of Repatha in Indian Subjects With Homozygous Familial Hypercholesterolemia","Evolocumab","PCSK9 Inhibitor","No",null,"No",null,"Phase 4",1,30,"Anticipated","2018-08-04","2020-08-10",{"$nulls":5},"To describe the safety and tolerability of Repatha in subjects with homozygous familial hypercholesterolemia (HoFH) in India. All subjects will receive Repatha over an 8 week period.","An open-label, multicentre, phase 4 study to describe the safety and tolerability of Repatha in 30 Indian subjects with HoFH. Subjects who meet the inclusion/exclusion criteria and laboratory assessments at screening will be enrolled and will be required to maintain their current lipid-lowering drug therapy throughout the duration of the trial. Subjects will receive Repatha 420 mg QM SC and study visits will occur approximately every 4 weeks. Apheresis subjects will receive Repatha 420 mg SC every 2 weeks to correspond with their apheresis schedule. Final administration of Repatha (for all subjects) will occur at week 8. The end of study (EOS) visit will occur at week 12 for all subjects.","A Multicenter, Open-label, Single-arm, Study to Evaluate Safety and Tolerability of Repatha in Patients With Homozygous Familial Hypercholesterolemia (HoFH) in India",20170199,"Homozygous Familial Hypercholesterolemia HoFH","Hypercholesterolemia","Metabolic Diseases","Nutritional Disorders","Experimental","RepathaÂ® (evolocumab)","Single arm, all subjects receive Repatha administered by subcutaneous injection via autoinjector(AI)/pen","Drug","Repatha&#xAE; (evolocumab)","Administered of Repatha by subcutaneous injection via autoinjector(AI)/pen",null,"RepathaÂ® (evolocumab)","\n\n * Male or female â‰¥ 12 to â‰¤ 80 years of age at the time of signing the informed consent.\n * Diagnosis of HoFH based on LDL-C, familial history and xanthoma\n * On a low-fat diet and receiving background lipid-lowering therapy stable for 4 weeks prior to screening and during the time frame of the trial.\n * Fasting LDL-C at screening > 130 mg/dL (3.4 mmol/L)\n * Fasting triglycerides at screening â‰¤ 400 mg/dL (4.5 mmol/L)\n\n","\n\n * Use of mipomersen or lomitapide within 6 months of screening.\n * Known active infection or major hematologic, renal, metabolic, gastrointestinal, hepatic, or endocrine dysfunction.\n * Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(ies).\n * Female subject is pregnant or breastfeeding or planning to become pregnant or breastfeed\n * Female subjects of childbearing potential unwilling to use an acceptable method of effective contraception\n * Subject has known sensitivity to any of the products to be administered during dosing.\n * History or evidence of any other clinically significant disorder, condition or disease\n * Subject has previously received evolocumab or any other PCSK9-inhibiting therapy.",{"$nulls":4},"Actual","2018-01-18","Actual","Anticipated","2020-08-10","Anticipated","2018-12-01","2018-01-03","2018-01-17","2018-12-14","No","Evolocumab\nHypercholesterolemia","Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","12 Years","80 Years","All",null,"No","Yes\nDe-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request",null,"URL: http://www.amgentrials.com [http://www.amgentrials.com] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: AmgenTrials clinical trials website",null,"No","No",{"$nulls":19},"Number of participants with treatment related Adverse Events","Characterize the safety and tolerability of Repatha based on an analysis of the subject incidence of treatment-emergent adverse events","12 weeks","Change in LDC-C|Change in ApoB|Change in Lp(a)","change from baseline to week 12 in low-density lipoprotein cholesterol (LDL-C)|change from baseline to week 12 apolipoprotein B (ApoB)|change from baseline to week 12 in lipoprotein(a)","Week 12|Lp(a) in HoFH patients in India","medinfo@amgen.com","Amgen Call Center","866-572-6436","New Delhi, Delhi, India, 110 002 Research SiteNew Delhi, Delhi, India, 110 029 Research SiteNew Delhi, Delhi, India, 110 060 Research SiteNew Delhi, Delhi, India, 110 062|Ahmedabad, Gujarat, India, 380 054|Bangalore, Karnataka, India, 560 017 Research SiteBelgaum, Karnataka, India, 590 010|Kochi, Kerala, India, 682 027|Mumbai, Maharashtra, India, 400 007 Research SitePune, Maharashtra, India, 411 005 Research SitePune, Maharashtra, India, 411 006",null,"India","Delhi Research Site|Gujarat Research Site|Karnataka Research Site|Kerala Research Site|Maharashtra Research Site",{"$nulls":3},"MD","2018-12-14","2020-05-25T16:37:30.458","2020-05-26T17:10:42.972","NCT03403374"]
["5ecbf44ae2561b1b11905db3","NCT03403374","2019-04-12","Amgen","AMGN","Recruiting","Safety and Tolerability of Repatha in Indian Subjects With Homozygous Familial Hypercholesterolemia","Evolocumab","PCSK9 Inhibitor","No",null,"No",null,"Phase 4",1,30,"Anticipated","2018-08-04","2019-09-20",{"$nulls":5},"To describe the safety and tolerability of Repatha in subjects with homozygous familial hypercholesterolemia (HoFH) in India. All subjects will receive Repatha over an 8 week period.","An open-label, multicentre, phase 4 study to describe the safety and tolerability of Repatha in 30 Indian subjects with HoFH. Subjects who meet the inclusion/exclusion criteria and laboratory assessments at screening will be enrolled and will be required to maintain their current lipid-lowering drug therapy throughout the duration of the trial. Subjects will receive Repatha 420 mg QM SC and study visits will occur approximately every 4 weeks. Apheresis subjects will receive Repatha 420 mg SC every 2 weeks to correspond with their apheresis schedule. Final administration of Repatha (for all subjects) will occur at week 8. The end of study (EOS) visit will occur at week 12 for all subjects.","A Multicenter, Open-label, Single-arm, Study to Evaluate Safety and Tolerability of Repatha in Patients With Homozygous Familial Hypercholesterolemia (HoFH) in India",20170199,"Homozygous Familial Hypercholesterolemia HoFH","Hypercholesterolemia","Metabolic Diseases","Nutritional Disorders","Experimental","RepathaÂ® (evolocumab)","Single arm, all subjects receive Repatha administered by subcutaneous injection via autoinjector(AI)/pen","Drug","Repatha&#xAE; (evolocumab)","Administered of Repatha by subcutaneous injection via autoinjector(AI)/pen",null,"RepathaÂ® (evolocumab)","\n\n * Male or female â‰¥ 12 to â‰¤ 80 years of age at the time of signing the informed consent.\n * Diagnosis of HoFH based on LDL-C, familial history and xanthoma\n * On a low-fat diet and receiving background lipid-lowering therapy stable for 4 weeks prior to screening and during the time frame of the trial.\n * Fasting LDL-C at screening > 130 mg/dL (3.4 mmol/L)\n * Fasting triglycerides at screening â‰¤ 400 mg/dL (4.5 mmol/L)\n\n","\n\n * Use of mipomersen or lomitapide within 6 months of screening.\n * Known active infection or major hematologic, renal, metabolic, gastrointestinal, hepatic, or endocrine dysfunction.\n * Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(ies).\n * Female subject is pregnant or breastfeeding or planning to become pregnant or breastfeed\n * Female subjects of childbearing potential unwilling to use an acceptable method of effective contraception\n * Subject has known sensitivity to any of the products to be administered during dosing.\n * History or evidence of any other clinically significant disorder, condition or disease\n * Subject has previously received evolocumab or any other PCSK9-inhibiting therapy.",{"$nulls":4},"Actual","2018-01-18","Actual","Anticipated","2019-09-20","Anticipated","2019-04-01","2018-01-03","2018-01-17","2019-04-10","No","Evolocumab\nHypercholesterolemia","Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","12 Years","80 Years","All",null,"No","Yes\nDe-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request",null,"URL: http://www.amgentrials.com [http://www.amgentrials.com] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: AmgenTrials clinical trials website",null,"No","No",{"$nulls":19},"Number of participants with treatment related Adverse Events","Characterize the safety and tolerability of Repatha based on an analysis of the subject incidence of treatment-emergent adverse events","12 weeks","Change in LDC-C|Change in ApoB|Change in Lp(a)","change from baseline to week 12 in low-density lipoprotein cholesterol (LDL-C)|change from baseline to week 12 apolipoprotein B (ApoB)|change from baseline to week 12 in lipoprotein(a)","Week 12|Lp(a) in HoFH patients in India","medinfo@amgen.com","Amgen Call Center","866-572-6436","New Delhi, Delhi, India, 110 002 Research SiteNew Delhi, Delhi, India, 110 029 Research SiteNew Delhi, Delhi, India, 110 060 Research SiteNew Delhi, Delhi, India, 110 062|Ahmedabad, Gujarat, India, 380 054|Bangalore, Karnataka, India, 560 017 Research SiteBelagavi, Karnataka, India, 590010|Kochi, Kerala, India, 682 027|Mumbai, Maharashtra, India, 400 007 Research SitePune, Maharashtra, India, 411 005 Research SitePune, Maharashtra, India, 411 006|Lucknow, Uttar Pradesh, India, 226 003",null,"India","Delhi Research Site|Gujarat Research Site|Karnataka Research Site|Kerala Research Site|Maharashtra Research Site|Uttar Pradesh Research Site",{"$nulls":3},"MD","2019-04-10","2020-05-25T16:37:30.387","2020-05-26T17:10:42.972","NCT03403374"]
["5ecbf44a307e3d1b1f8d9d49","NCT03403374","2019-12-05","Amgen","AMGN","Completed","Safety and Tolerability of Repatha in Indian Subjects With Homozygous Familial Hypercholesterolemia","Evolocumab","PCSK9 Inhibitor","No",null,"No",null,"Phase 4",1,30,"Actual","2018-08-04","2019-11-27",{"$nulls":5},"To describe the safety and tolerability of Repatha in subjects with homozygous familial hypercholesterolemia (HoFH) in India. All subjects will receive Repatha over an 8 week period.","An open-label, multicentre, phase 4 study to describe the safety and tolerability of Repatha in 30 Indian subjects with HoFH. Subjects who meet the inclusion/exclusion criteria and laboratory assessments at screening will be enrolled and will be required to maintain their current lipid-lowering drug therapy throughout the duration of the trial. Subjects will receive Repatha 420 mg QM SC and study visits will occur approximately every 4 weeks. Apheresis subjects will receive Repatha 420 mg SC every 2 weeks to correspond with their apheresis schedule. Final administration of Repatha (for all subjects) will occur at week 8. The end of study (EOS) visit will occur at week 12 for all subjects.","A Multicenter, Open-label, Single-arm, Study to Evaluate Safety and Tolerability of Repatha in Patients With Homozygous Familial Hypercholesterolemia (HoFH) in India",20170199,"Homozygous Familial Hypercholesterolemia HoFH","Hypercholesterolemia","Metabolic Diseases","Nutritional Disorders","Experimental","RepathaÂ® (evolocumab)","Single arm, all subjects receive Repatha administered by subcutaneous injection via autoinjector(AI)/pen","Drug","Repatha&#xAE; (evolocumab)","Administered of Repatha by subcutaneous injection via autoinjector(AI)/pen",null,"RepathaÂ® (evolocumab)","\n\n * Male or female â‰¥ 12 to â‰¤ 80 years of age at the time of signing the informed consent.\n * Diagnosis of HoFH based on LDL-C, familial history and xanthoma\n * On a low-fat diet and receiving background lipid-lowering therapy stable for 4 weeks prior to screening and during the time frame of the trial.\n * Fasting LDL-C at screening > 130 mg/dL (3.4 mmol/L)\n * Fasting triglycerides at screening â‰¤ 400 mg/dL (4.5 mmol/L)\n\n","\n\n * Use of mipomersen or lomitapide within 6 months of screening.\n * Known active infection or major hematologic, renal, metabolic, gastrointestinal, hepatic, or endocrine dysfunction.\n * Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(ies).\n * Female subject is pregnant or breastfeeding or planning to become pregnant or breastfeed\n * Female subjects of childbearing potential unwilling to use an acceptable method of effective contraception\n * Subject has known sensitivity to any of the products to be administered during dosing.\n * History or evidence of any other clinically significant disorder, condition or disease\n * Subject has previously received evolocumab or any other PCSK9-inhibiting therapy.",{"$nulls":4},"Actual","2018-01-18","Actual","Actual","2019-11-27","Actual","2019-12-01","2018-01-03","2018-01-17","2019-12-04","No","Evolocumab\nHypercholesterolemia","Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","12 Years","80 Years","All",null,"No","Yes\nDe-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request",null,"URL: http://www.amgentrials.com [http://www.amgentrials.com] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: AmgenTrials clinical trials website",null,"No","No",{"$nulls":19},"Number of participants with treatment related Adverse Events","Characterize the safety and tolerability of Repatha based on an analysis of the subject incidence of treatment-emergent adverse events","12 weeks","Change in LDC-C|Change in ApoB|Change in Lp(a)","change from baseline to week 12 in low-density lipoprotein cholesterol (LDL-C)|change from baseline to week 12 apolipoprotein B (ApoB)|change from baseline to week 12 in lipoprotein(a)","Week 12|Lp(a) in HoFH patients in India",{"$nulls":3},"New Delhi, Delhi, India, 110 002 Research SiteNew Delhi, Delhi, India, 110 029 Research SiteNew Delhi, Delhi, India, 110 060 Research SiteNew Delhi, Delhi, India, 110 062|Ahmedabad, Gujarat, India, 380 054|Bangalore, Karnataka, India, 560 017 Research SiteBelagavi, Karnataka, India, 590010|Kochi, Kerala, India, 682 027|Mumbai, Maharashtra, India, 400 007 Research SitePune, Maharashtra, India, 411 005 Research SitePune, Maharashtra, India, 411 006|Lucknow, Uttar Pradesh, India, 226 003",null,"India","Delhi Research Site|Gujarat Research Site|Karnataka Research Site|Kerala Research Site|Maharashtra Research Site|Uttar Pradesh Research Site",{"$nulls":3},"MD","2019-12-04","2020-05-25T16:37:30.512","2020-05-26T17:10:42.972","NCT03403374"]
["5ecbf44f307e3d1b1f8d9d53","NCT03404024","2018-01-29","Helixmith","VRMDF","Recruiting","Safety and Efficacy Study of Gene Therapy for Acute Myocardial Infarction in Korea","Sodium chloride",null,"Unknown",null,"Unknown",null,"Phase 2",6,108,"Anticipated","2018-01-25","2020-04-01","MTD","Maximum Tolerated Dose",{"$nulls":3},"The purpose of this study is to evaluate the safety and clinical efficacy of VM202RY injected via transendocardial route using C-CathezÂ® catheter (Celyad, S.A., Belgium) in subjects with AMI.\n\n * Stage 1: Evaluation of safety and tolerability of VM202RY injection\n * Stage 2: Evaluation of safety and efficacy of VM202RY injection","Ischemic heart disease, a condition in which narrowed or blocked coronary arteries lead to ischemia in myocardium, is a group of disease that include: angina and myocardial infarction.\n\nAcute myocardial infarction (AMI) predicts rapid progression of necrosis. AMI is a serious health condition that it's mortality rate is about 30% and also more likely to have a higher incidence of cardiac dysrhythmia or ventricular aneurysm.\n\nTherapeutic angiogenesis is promising approach for the treatment of cardiovascular disease. 66 to 75% of coronary artery disease patients have insufficient coronary collaterals and 30% of myocardial infarction patients display inadequate myocardial perfusion although there are procedures like percutaneous coronary intervention or coronary artery bypass graft surgery.\n\nIn phase I study for ischemic heart disease, VM202RY appeared to have improved regional myocardial perfusion and wall thickness of the diastolic and systolic phases in the injected region. These results suggest that VM202RY improves the myocardial perfusion and inhibits cardiac remodeling in ischemic heart disease patients.","A Phase II, Multicenter, Adaptive-design Study to Assess the Safety and Efficacy of VM202RY Injected Via Percutaneous Transendocardial Route in Subjects With Acute Myocardial Infarction","VMCAD-002","Ischemic Heart Disease\nAcute Myocardial Infarction","Myocardial Infarction","Heart Diseases","Cardiovascular","Experimental|Placebo Comparator","Stage 1-Low dose VM202RY|Stage 1-Middle dose VM202RY|Stage 1-High dose VM202RY|Stage 2-Placebo|Stage 2-Low dose VM202RY|Stage 2-High dose VM202RY","Patients in this group will receive total 1mg of VM202RY. (4 sites of 0.25mg/0.5 mL VM202RY)|Patients in this group will receive total 2mg of VM202RY. (8 sites of 0.25mg/0.5 mL VM202RY)|Patients in this group will receive total 3mg of VM202RY. (12 sites of 0.25mg/0.5 mL VM202RY)|Patients in this group will receive 6mL of VM202RY vehicle. (12 sites of 0.5mL 0.9% NaCl, 1.1% sucrose)|Patients in this group will receive total 6mL of VM202RY and VM202RY vehicle. (The dose of VM202RY can be one of the three candidate-0.5mg VM202RY/1mg VM202RY/1.5mg VM202RY based on the tolerated dose result from Stage 1.)|Patients in this group will receive total 6mL of VM202RY and VM202RY vehicle. (The dose of VM202RY can be one of the three candidate-1mg VM202RY/2mg VM202RY/3mg VM202RY based on the tolerated dose result from Stage 1.)","Biological|Device|Drug","Stage 1-Low dose VM202RY|C-Cathez&#xAE; Catheter|Stage 1-Middle dose VM202RY|Stage 1-High dose VM202RY|Stage 2-Placebo|Stage 2-Low dose VM202RY|Stage 2-High dose VM202RY","Day 0: 1mg of VM202RY (4 sites of 0.25mg/0.5mL VM202RY)|Day 0 (Stage 1-Low dose VM202RY): 1mg of VM202RY (4 sites of 0.25mg/0.5mL VM202RY) Day 0 (Stage 1-Middle dose VM202RY): 2mg of VM202RY (8 sites of 0.25mg/0.5mL VM202RY) Day 0 (Stage 1-High dose VM202RY): 3mg of VM202RY (12 sites of 0.25mg/0.5mL VM202RY) Day 0 (Stage 2-Placebo): 6mL of VM202RY vehicle (12 sites of 0.5mL 1.1% sucrose/0.9% NaCl) Day 0 (Stage 2-Low dose VM202RY): 6mL of VM202RY and VM202RY vehicle (total 12 site injections, low dose candidate-0.5mg VM202RY, 1mg VM202RY, 1.5mg VM202RY) Day 0 (Stage 2-High dose VM202RY): 6mL of VM202RY and VM202RY vehicle (total 12 site injections, high dose candidate-1mg VM202RY, 2mg VM202RY, 3mg VM202RY)|Day 0: 2mg of VM202RY (8 sites of 0.25mg/0.5mL VM202RY)|Day 0: 3mg of VM202RY (12 sites of 0.25mg/0.5mL VM202RY)|Day 0: 6mL of VM202RY vehicle (12 sites of 0.5mL 1.1% sucrose/0.9% NaCl)|Day 0: 6mL of VM202RY and VM202RY vehicle (total 12 site injections, low dose candidate-0.5mg VM202RY, 1mg VM202RY, 1.5mg VM202RY)|Day 0: 6mL of VM202RY and VM202RY vehicle (total 12 site injections, high dose candidate-1mg VM202RY, 2mg VM202RY, 3mg VM202RY)","DNA Plasmid | Hepatocyte growth factor (HGF)-X7|DNA Plasmid | HGF-X7|VM202RY vehicle | Sodium chloride, sucrose|DNA plasmid | HGF-X7","Stage 1-Low dose VM202RY|Stage 1-Middle dose VM202RY|Stage 1-High dose VM202RY|Stage 2-Placebo|Stage 2-Low dose VM202RY|Stage 2-High dose VM202RY","\n\n 1. Age â‰¥ 19 years to â‰¤ 75 years\n 2. Patients who underwent percutaneous coronary intervention (PCI) for the anterior wall infarction of left ventricle and had the elapsed time of 30 Â± 2 days from the PCI, regardless of success or failure of myocardial revascularization in the anterior wall\n 3. Patients with > 20% to â‰¤ 45% of left ventricular ejection fraction via trans-thoracic echocardiography within 7 days prior to the study drug or placebo injection\n 4. Left ventricular wall thickness â‰¥ 8 mm via trans-thoracic echocardiography\n 5. If female of childbearing potential, negative urine pregnancy test at screening and using acceptable method of birth control during the study; if male, using barrier method of birth control during study\n 6. Be capable of understanding and complying with the protocol and signing the informed consent document prior to being subjected to any study related procedures.\n\n","\n\n 1.  Severe systolic heart failure, NYHA Class III or IV\n 2.  New York Heart Association (NYHA) functional class IV\n 3.  History of recurrent ventricular tachycardia or cariogenic shock following PCI\n 4.  Stroke or transient ischemic attack (TIA) within 180 days\n 5.  Uncontrolled hypertension defined as systolic blood pressure â‰¥ 180 mmHg or diastolic â‰¥ 110 mmHg at screening and/or on the day of study drug or placebo injection\n 6.  Sustained ventricular tachyarrhythmia or recurrent ventricular tachycardia\n 7.  Implantation of automatic implantable cardioverter defibrillator (AICD)\n 8.  On extracorporeal membrane oxygenator (ECMO)\n 9.  History of ventricular fibrillation after PCI\n 10. Permanent pacemaker implantation (temporary pacemaker may be enrolled)\n 11. Subjects with aortic stenosis of moderate or greater degree, or with prosthetic aortic valve who may not be appropriate to use the C-CATHezÂ® catheter due to the risk of injury during the interventional procedure through the valve\n 12. Atherosclerotic or other disease of the aorto-iliac system that would impede the safe passage of the C-CATHezÂ®\n 13. Subjects with any serious comorbidities that the investigators deemed to be inappropriate to be enrolled\n 14. Patients with a recent history (< 5 years) of, or new screening finding of malignant neoplasm except basal cell carcinoma or squamous cell carcinoma of the skin (if excised and no evidence of recurrence); patients with family history of colon cancer in any first degree relative are excluded unless they have undergone a colonoscopy in the last 12 months with negative findings\n 15. Elevated prostate-specific antigen (PSA) despite not having prostate cancer history\n 16. Ophthalmologic conditions pertinent to proliferative retinopathy or conditions that preclude standard ophthalmologic examination Diagnosis of proliferative retinopathy or conditions that preclude standard ophthalmologic examination\n 17. Subjects currently receiving immunosuppressive medications, chemotherapy, or radiation therapy\n 18. Active infectious disease and/or positive Human Immunodeficiency Virus (HIV) or Human T-Cell lymphotropic viruses (HTLV) at screening\n 19. Active Hepatitis B or C infection as determined by Hepatitis B surface antibody (HBsAb), Hepatitis B core antibody (Immunoglobulin G and Immunoglobulin M; HBcAb), Hepatitis B surface antigen (HBsAg) and Hepatitis C antibodies (Anti-HCV) at screening\n 20. Specific laboratory values at screening including * Hemoglobin â‰¤ 9.0 g/dL, white blood cell (WBC) < 3,000 cells/Î¼l, platelet count < 75,000/mm3\n      * Creatinine > 2.0 mg/dL\n      * Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 3 x upper limit of normal (ULN)\n      * Any other clinically significant lab abnormality which in the opinion of the investigator should be exclusionary\n     \n     \n 21. Subjects requiring > 100 mg daily of acetylsalicylic acid (ASA); subjects may be enrolled if willing/able to switch to â‰¤ 100 mg daily of ASA or to another medication\n 22. Subjects regularly taking cyclooxygenase (COX)-2 inhibiting drug(s) or non-specific COX-1/COX-2 inhibiting drugs, or high dose steroids (except inhaled steroids); subjects may be enrolled if willing/able to undergo medication wash-out prior to the first dosing and to refrain from taking these drugs for the duration of the study, and also if the subject is temporarily taking NSAID (non-steroidal anti-inflammatory drug) temporarily (â‰¤ 7 days)\n 23. Patients that have undergone enhanced external pulsation (EECP) treatment within the last 6 months\n 24. Pregnancy or lactation\n 25. Severe comorbidity associated with a reduction of life expectancy of less than 1 year\n 26. Exposure to any previous experimental angiogenic therapy and/or myocardial laser therapy; or therapy with another investigational drug within 180 days of enrollment or participation in any concurrent study that may confound the results of this study\n 27. Major psychiatric disorder in the past 6 months\n 28. Known drug or alcohol dependence or any other factors which will interfere with the study conduct or interpretation of the results or who in the opinion of the investigator are not suitable to participate",{"$nulls":4},"Actual","2018-01-19","Actual","Anticipated","2020-04-01","Anticipated","2018-01-01","2017-08-16","2018-01-18","2018-01-25","Yes","gene therapy","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","19 Years","75 Years","All",null,"No","Undecided",{"$nulls":3},"No","No",{"$nulls":4},"Yes",{"$nulls":14},"Stage 1: MTD (maximum tolerated dose)|Stage 2: LVEF (left ventricular ejection fraction) measured by cardiac MRI","â€¢ MTD is defined as the dose level below the dose at which â‰¥ 33% of participants experienced DLT (dose limiting toxicity). The DLT assessment will be conducted on day 14. Toxicities more severe than grade 3 on the WHO toxicity scale will be designated as DLT. The dose where severe adverse events occur according to the Spilker classification will also be designated as DLT. The assessment will be conducted from the lowest dose to higher doses incrementally. MTD will be measured in milligrams (mg).|â€¢ The change in LVEF measured by cardiac MRI in VM202RY and placebo will be compared at 6 months after the treatment of VM202RY or Placebo by transendocardial injections using C-CATHezÂ® catheter. LVEF will be measured in percentage (%).","6 months","Change in left ventricular diameter (cardiac MRI)|Change in left ventricular diameter (TTE)|Change in left ventricular volume (cardiac MRI)|Change in left ventricular volume (TTE)|Change in cardiac output (cardiac MRI)|Change in cardiac output (TTE)|Change in LVEF (cardiac MRI)|Change in LVEF (TTE)|Change in wall motion score index (cardiac MRI)|Change in wall motion score index (TTE)|Change in myocardial wall thickness (cardiac MRI)|Change in extent of late enhancement of gadolinium (cardiac MRI)|Change in rest perfusion (cardiac MRI)|Change in rest perfusion (myocardial SPECT)|Change in stress perfusion (cardiac MRI)|Change in stress perfusion (myocardial SPECT)","The change in diameter of left ventricle will be measured in millimeters (mm), at months 3 and 6 using cardiac MRI.|The change in diameter of left ventricle will be measured in millimeters (mm), at months 3 and 6 using TTE (transthoracic echocardiogram).|The change in volume of left ventricle will be measured in milliliters (mL), at months 3 and 6 using cardiac MRI.|The change in volume of left ventricle will be measured in milliliters (mL), at months 3 and 6 using TTE.|The change in cardiac output will be measured in liters per minute (L/min), at months 3 and 6 using cardiac MRI.|The change in cardiac output will be measured in liters per minute (L/min), at months 3 and 6 using TTE.|The change in left ventricular ejection fraction will be measured in percentage (%), at months 3 and 6 using cardiac MRI.|The change in left ventricular ejection fraction will be measured in percentage (%), at months 3 and 6 using TTE.|The wall motion score index will be measured at months 3 and 6 using cardiac MRI.|The wall motion score index will be measured at months 3 and 6 using TTE.|The change in myocardial wall thickness of the investigational-product or placebo injected area will be measured in millimeters (mm) at months 3 and 6 using cardiac MRI.|The change in extent of late enhancement of gadolinium will be measured at months 3 and 6 using cardiac MRI.|The change in rest perfusion will be measured in percentage (%) at months 3 and 6 using cardiac MRI.|The change in rest perfusion will be measured in percentage (%) at months 3 and 6 using myocardial SPECT.|The change in stress perfusion will be measured in percentage (%) at months 3 and 6 using cardiac MRI.|The change in stress perfusion will be measured in percentage (%) at months 3 and 6 using myocardial SPECT.","3 and 6 months","hsyoon@viromed.co.kr","Hong Sik Yoon, PharmD","02-2102-7200",{"$nulls":8},"2018-01-25","2020-05-25T16:37:35.272","2020-05-26T17:10:42.972","NCT03404024"]
["5ecbf44ffeab101b155308f3","NCT03404024","2018-02-07","Helixmith","VRMDF","Recruiting","Safety and Efficacy Study of Gene Therapy for Acute Myocardial Infarction in Korea","Sodium chloride",null,"Unknown",null,"Unknown",null,"Phase 2",6,108,"Anticipated","2018-01-25","2020-04-01","MTD","Maximum Tolerated Dose",{"$nulls":3},"The purpose of this study is to evaluate the safety and clinical efficacy of VM202RY injected via transendocardial route using C-CathezÂ® catheter (Celyad, S.A., Belgium) in subjects with AMI.\n\n * Stage 1: Evaluation of safety and tolerability of VM202RY injection\n * Stage 2: Evaluation of safety and efficacy of VM202RY injection","Ischemic heart disease, a condition in which narrowed or blocked coronary arteries lead to ischemia in myocardium, is a group of disease that include: angina and myocardial infarction.\n\nAcute myocardial infarction (AMI) predicts rapid progression of necrosis. AMI is a serious health condition that it's mortality rate is about 30% and also more likely to have a higher incidence of cardiac dysrhythmia or ventricular aneurysm.\n\nTherapeutic angiogenesis is promising approach for the treatment of cardiovascular disease. 66 to 75% of coronary artery disease patients have insufficient coronary collaterals and 30% of myocardial infarction patients display inadequate myocardial perfusion although there are procedures like percutaneous coronary intervention or coronary artery bypass graft surgery.\n\nIn phase I study for ischemic heart disease, VM202RY appeared to have improved regional myocardial perfusion and wall thickness of the diastolic and systolic phases in the injected region. These results suggest that VM202RY improves the myocardial perfusion and inhibits cardiac remodeling in ischemic heart disease patients.","A Phase II, Multicenter, Adaptive-design Study to Assess the Safety and Efficacy of VM202RY Injected Via Percutaneous Transendocardial Route in Subjects With Acute Myocardial Infarction","VMCAD-002","Ischemic Heart Disease\nAcute Myocardial Infarction","Myocardial Infarction","Heart Diseases","Cardiovascular","Experimental|Placebo Comparator","Stage 1-Low dose VM202RY|Stage 1-Middle dose VM202RY|Stage 1-High dose VM202RY|Stage 2-Placebo|Stage 2-Low dose VM202RY|Stage 2-High dose VM202RY","Patients in this group will receive total 1mg of VM202RY. (4 sites of 0.25mg/0.5 mL VM202RY)|Patients in this group will receive total 2mg of VM202RY. (8 sites of 0.25mg/0.5 mL VM202RY)|Patients in this group will receive total 3mg of VM202RY. (12 sites of 0.25mg/0.5 mL VM202RY)|Patients in this group will receive 6mL of VM202RY vehicle. (12 sites of 0.5mL 0.9% NaCl, 1.1% sucrose)|Patients in this group will receive total 6mL of VM202RY and VM202RY vehicle. (The dose of VM202RY can be one of the three candidate-0.5mg VM202RY/1mg VM202RY/1.5mg VM202RY based on the tolerated dose result from Stage 1.)|Patients in this group will receive total 6mL of VM202RY and VM202RY vehicle. (The dose of VM202RY can be one of the three candidate-1mg VM202RY/2mg VM202RY/3mg VM202RY based on the tolerated dose result from Stage 1.)","Biological|Device|Drug","Stage 1-Low dose VM202RY|C-Cathez&#xAE; Catheter|Stage 1-Middle dose VM202RY|Stage 1-High dose VM202RY|Stage 2-Placebo|Stage 2-Low dose VM202RY|Stage 2-High dose VM202RY","Day 0: 1mg of VM202RY (4 sites of 0.25mg/0.5mL VM202RY)|Day 0 (Stage 1-Low dose VM202RY): 1mg of VM202RY (4 sites of 0.25mg/0.5mL VM202RY) Day 0 (Stage 1-Middle dose VM202RY): 2mg of VM202RY (8 sites of 0.25mg/0.5mL VM202RY) Day 0 (Stage 1-High dose VM202RY): 3mg of VM202RY (12 sites of 0.25mg/0.5mL VM202RY) Day 0 (Stage 2-Placebo): 6mL of VM202RY vehicle (12 sites of 0.5mL 1.1% sucrose/0.9% NaCl) Day 0 (Stage 2-Low dose VM202RY): 6mL of VM202RY and VM202RY vehicle (total 12 site injections, low dose candidate-0.5mg VM202RY, 1mg VM202RY, 1.5mg VM202RY) Day 0 (Stage 2-High dose VM202RY): 6mL of VM202RY and VM202RY vehicle (total 12 site injections, high dose candidate-1mg VM202RY, 2mg VM202RY, 3mg VM202RY)|Day 0: 2mg of VM202RY (8 sites of 0.25mg/0.5mL VM202RY)|Day 0: 3mg of VM202RY (12 sites of 0.25mg/0.5mL VM202RY)|Day 0: 6mL of VM202RY vehicle (12 sites of 0.5mL 1.1% sucrose/0.9% NaCl)|Day 0: 6mL of VM202RY and VM202RY vehicle (total 12 site injections, low dose candidate-0.5mg VM202RY, 1mg VM202RY, 1.5mg VM202RY)|Day 0: 6mL of VM202RY and VM202RY vehicle (total 12 site injections, high dose candidate-1mg VM202RY, 2mg VM202RY, 3mg VM202RY)","DNA Plasmid | Hepatocyte growth factor (HGF)-X7|DNA Plasmid | HGF-X7|VM202RY vehicle | Sodium chloride, sucrose|DNA plasmid | HGF-X7","Stage 1-Low dose VM202RY|Stage 1-Middle dose VM202RY|Stage 1-High dose VM202RY|Stage 2-Placebo|Stage 2-Low dose VM202RY|Stage 2-High dose VM202RY","\n\n 1. Age â‰¥ 19 years to â‰¤ 75 years\n 2. Patients who underwent percutaneous coronary intervention (PCI) for the anterior wall infarction of left ventricle and had the elapsed time of 30 Â± 2 days from the PCI, regardless of success or failure of myocardial revascularization in the anterior wall\n 3. Patients with > 20% to â‰¤ 45% of left ventricular ejection fraction via trans-thoracic echocardiography within 7 days prior to the study drug or placebo injection\n 4. Left ventricular wall thickness â‰¥ 8 mm via trans-thoracic echocardiography\n 5. If female of childbearing potential, negative urine pregnancy test at screening and using acceptable method of birth control during the study; if male, using barrier method of birth control during study\n 6. Be capable of understanding and complying with the protocol and signing the informed consent document prior to being subjected to any study related procedures.\n\n","\n\n 1.  Severe systolic heart failure, NYHA Class III or IV\n 2.  New York Heart Association (NYHA) functional class IV\n 3.  History of recurrent ventricular tachycardia or cariogenic shock following PCI\n 4.  Stroke or transient ischemic attack (TIA) within 180 days\n 5.  Uncontrolled hypertension defined as systolic blood pressure â‰¥ 180 mmHg or diastolic â‰¥ 110 mmHg at screening and/or on the day of study drug or placebo injection\n 6.  Sustained ventricular tachyarrhythmia or recurrent ventricular tachycardia\n 7.  Implantation of automatic implantable cardioverter defibrillator (AICD)\n 8.  On extracorporeal membrane oxygenator (ECMO)\n 9.  History of ventricular fibrillation after PCI\n 10. Permanent pacemaker implantation (temporary pacemaker may be enrolled)\n 11. Subjects with aortic stenosis of moderate or greater degree, or with prosthetic aortic valve who may not be appropriate to use the C-CATHezÂ® catheter due to the risk of injury during the interventional procedure through the valve\n 12. Atherosclerotic or other disease of the aorto-iliac system that would impede the safe passage of the C-CATHezÂ®\n 13. Subjects with any serious comorbidities that the investigators deemed to be inappropriate to be enrolled\n 14. Patients with a recent history (< 5 years) of, or new screening finding of malignant neoplasm except basal cell carcinoma or squamous cell carcinoma of the skin (if excised and no evidence of recurrence); patients with family history of colon cancer in any first degree relative are excluded unless they have undergone a colonoscopy in the last 12 months with negative findings\n 15. Elevated prostate-specific antigen (PSA) despite not having prostate cancer history\n 16. Ophthalmologic conditions pertinent to proliferative retinopathy or conditions that preclude standard ophthalmologic examination Diagnosis of proliferative retinopathy or conditions that preclude standard ophthalmologic examination\n 17. Subjects currently receiving immunosuppressive medications, chemotherapy, or radiation therapy\n 18. Active infectious disease and/or positive Human Immunodeficiency Virus (HIV) or Human T-Cell lymphotropic viruses (HTLV) at screening\n 19. Active Hepatitis B or C infection as determined by Hepatitis B surface antibody (HBsAb), Hepatitis B core antibody (Immunoglobulin G and Immunoglobulin M; HBcAb), Hepatitis B surface antigen (HBsAg) and Hepatitis C antibodies (Anti-HCV) at screening\n 20. Specific laboratory values at screening including * Hemoglobin â‰¤ 9.0 g/dL, white blood cell (WBC) < 3,000 cells/Î¼l, platelet count < 75,000/mm3\n      * Creatinine > 2.0 mg/dL\n      * Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 3 x upper limit of normal (ULN)\n      * Any other clinically significant lab abnormality which in the opinion of the investigator should be exclusionary\n     \n     \n 21. Subjects requiring > 100 mg daily of acetylsalicylic acid (ASA); subjects may be enrolled if willing/able to switch to â‰¤ 100 mg daily of ASA or to another medication\n 22. Subjects regularly taking cyclooxygenase (COX)-2 inhibiting drug(s) or non-specific COX-1/COX-2 inhibiting drugs, or high dose steroids (except inhaled steroids); subjects may be enrolled if willing/able to undergo medication wash-out prior to the first dosing and to refrain from taking these drugs for the duration of the study, and also if the subject is temporarily taking NSAID (non-steroidal anti-inflammatory drug) temporarily (â‰¤ 7 days)\n 23. Patients that have undergone enhanced external pulsation (EECP) treatment within the last 6 months\n 24. Pregnancy or lactation\n 25. Severe comorbidity associated with a reduction of life expectancy of less than 1 year\n 26. Exposure to any previous experimental angiogenic therapy and/or myocardial laser therapy; or therapy with another investigational drug within 180 days of enrollment or participation in any concurrent study that may confound the results of this study\n 27. Major psychiatric disorder in the past 6 months\n 28. Known drug or alcohol dependence or any other factors which will interfere with the study conduct or interpretation of the results or who in the opinion of the investigator are not suitable to participate",{"$nulls":4},"Actual","2018-01-19","Actual","Anticipated","2020-04-01","Anticipated","2018-02-01","2017-08-16","2018-01-18","2018-02-06","Yes","gene therapy","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","19 Years","75 Years","All",null,"No","Undecided",{"$nulls":3},"No","No",{"$nulls":4},"Yes",{"$nulls":14},"Stage 1: MTD (maximum tolerated dose)|Stage 2: LVEF (left ventricular ejection fraction) measured by cardiac MRI","â€¢ MTD is defined as the dose level below the dose at which â‰¥ 33% of participants experienced DLT (dose limiting toxicity). The DLT assessment will be conducted on day 14. Toxicities more severe than grade 3 on the WHO toxicity scale will be designated as DLT. The dose where severe adverse events occur according to the Spilker classification will also be designated as DLT. The assessment will be conducted from the lowest dose to higher doses incrementally. MTD will be measured in milligrams (mg).|â€¢ The change in LVEF measured by cardiac MRI in VM202RY and placebo will be compared at 6 months after the treatment of VM202RY or Placebo by transendocardial injections using C-CATHezÂ® catheter. LVEF will be measured in percentage (%).","6 months","Change in left ventricular diameter (cardiac MRI)|Change in left ventricular diameter (TTE)|Change in left ventricular volume (cardiac MRI)|Change in left ventricular volume (TTE)|Change in cardiac output (cardiac MRI)|Change in cardiac output (TTE)|Change in LVEF (cardiac MRI)|Change in LVEF (TTE)|Change in wall motion score index (cardiac MRI)|Change in wall motion score index (TTE)|Change in myocardial wall thickness (cardiac MRI)|Change in extent of late enhancement of gadolinium (cardiac MRI)|Change in rest perfusion (cardiac MRI)|Change in rest perfusion (myocardial SPECT)|Change in stress perfusion (cardiac MRI)|Change in stress perfusion (myocardial SPECT)","The change in diameter of left ventricle will be measured in millimeters (mm), at months 3 and 6 using cardiac MRI.|The change in diameter of left ventricle will be measured in millimeters (mm), at months 3 and 6 using TTE (transthoracic echocardiogram).|The change in volume of left ventricle will be measured in milliliters (mL), at months 3 and 6 using cardiac MRI.|The change in volume of left ventricle will be measured in milliliters (mL), at months 3 and 6 using TTE.|The change in cardiac output will be measured in liters per minute (L/min), at months 3 and 6 using cardiac MRI.|The change in cardiac output will be measured in liters per minute (L/min), at months 3 and 6 using TTE.|The change in left ventricular ejection fraction will be measured in percentage (%), at months 3 and 6 using cardiac MRI.|The change in left ventricular ejection fraction will be measured in percentage (%), at months 3 and 6 using TTE.|The wall motion score index will be measured at months 3 and 6 using cardiac MRI.|The wall motion score index will be measured at months 3 and 6 using TTE.|The change in myocardial wall thickness of the investigational-product or placebo injected area will be measured in millimeters (mm) at months 3 and 6 using cardiac MRI.|The change in extent of late enhancement of gadolinium will be measured at months 3 and 6 using cardiac MRI.|The change in rest perfusion will be measured in percentage (%) at months 3 and 6 using cardiac MRI.|The change in rest perfusion will be measured in percentage (%) at months 3 and 6 using myocardial SPECT.|The change in stress perfusion will be measured in percentage (%) at months 3 and 6 using cardiac MRI.|The change in stress perfusion will be measured in percentage (%) at months 3 and 6 using myocardial SPECT.","3 and 6 months","hsyoon@viromed.co.kr","Hong Sik Yoon, PharmD","02-2102-7200",{"$nulls":8},"2018-02-06","2020-05-25T16:37:35.403","2020-05-26T17:10:42.972","NCT03404024"]
["5ecbf44f11702c1b1b916ad3","NCT03404024","2019-10-24","Helixmith","VRMDF","Recruiting","Safety and Efficacy Study of Gene Therapy for Acute Myocardial Infarction in Korea","Sodium chloride",null,"Unknown",null,"Unknown",null,"Phase 2",6,108,"Anticipated","2018-01-25","2020-04-01","MTD","Maximum Tolerated Dose",{"$nulls":3},"The purpose of this study is to evaluate the safety and clinical efficacy of VM202RY injected via transendocardial route using C-CathezÂ® catheter (Celyad, S.A., Belgium) in subjects with AMI.\n\n * Stage 1: Evaluation of safety and tolerability of VM202RY injection\n * Stage 2: Evaluation of safety and efficacy of VM202RY injection","Ischemic heart disease, a condition in which narrowed or blocked coronary arteries lead to ischemia in myocardium, is a group of disease that include: angina and myocardial infarction.\n\nAcute myocardial infarction (AMI) predicts rapid progression of necrosis. AMI is a serious health condition that it's mortality rate is about 30% and also more likely to have a higher incidence of cardiac dysrhythmia or ventricular aneurysm.\n\nTherapeutic angiogenesis is promising approach for the treatment of cardiovascular disease. 66 to 75% of coronary artery disease patients have insufficient coronary collaterals and 30% of myocardial infarction patients display inadequate myocardial perfusion although there are procedures like percutaneous coronary intervention or coronary artery bypass graft surgery.\n\nIn phase I study for ischemic heart disease, VM202RY appeared to have improved regional myocardial perfusion and wall thickness of the diastolic and systolic phases in the injected region. These results suggest that VM202RY improves the myocardial perfusion and inhibits cardiac remodeling in ischemic heart disease patients.","A Phase II, Multicenter, Adaptive-design Study to Assess the Safety and Efficacy of VM202RY Injected Via Percutaneous Transendocardial Route in Subjects With Acute Myocardial Infarction","VMCAD-002","Ischemic Heart Disease\nAcute Myocardial Infarction","Myocardial Infarction","Heart Diseases","Cardiovascular","Experimental|Placebo Comparator","Stage 1-Low dose VM202RY|Stage 1-Middle dose VM202RY|Stage 1-High dose VM202RY|Stage 2-Placebo|Stage 2-Low dose VM202RY|Stage 2-High dose VM202RY","Patients in this group will receive total 1mg of VM202RY. (4 sites of 0.25mg/0.5 mL VM202RY)|Patients in this group will receive total 2mg of VM202RY. (8 sites of 0.25mg/0.5 mL VM202RY)|Patients in this group will receive total 3mg of VM202RY. (12 sites of 0.25mg/0.5 mL VM202RY)|Patients in this group will receive 6mL of VM202RY vehicle. (12 sites of 0.5mL 0.9% NaCl, 1.1% sucrose)|Patients in this group will receive total 6mL of VM202RY and VM202RY vehicle. (The dose of VM202RY can be one of the three candidate-0.5mg VM202RY/1mg VM202RY/1.5mg VM202RY based on the tolerated dose result from Stage 1.)|Patients in this group will receive total 6mL of VM202RY and VM202RY vehicle. (The dose of VM202RY can be one of the three candidate-1mg VM202RY/2mg VM202RY/3mg VM202RY based on the tolerated dose result from Stage 1.)","Biological|Device|Drug","Stage 1-Low dose VM202RY|C-Cathez&#xAE; Catheter|Stage 1-Middle dose VM202RY|Stage 1-High dose VM202RY|Stage 2-Placebo|Stage 2-Low dose VM202RY|Stage 2-High dose VM202RY","Day 0: 1mg of VM202RY (4 sites of 0.25mg/0.5mL VM202RY)|Day 0 (Stage 1-Low dose VM202RY): 1mg of VM202RY (4 sites of 0.25mg/0.5mL VM202RY) Day 0 (Stage 1-Middle dose VM202RY): 2mg of VM202RY (8 sites of 0.25mg/0.5mL VM202RY) Day 0 (Stage 1-High dose VM202RY): 3mg of VM202RY (12 sites of 0.25mg/0.5mL VM202RY) Day 0 (Stage 2-Placebo): 6mL of VM202RY vehicle (12 sites of 0.5mL 1.1% sucrose/0.9% NaCl) Day 0 (Stage 2-Low dose VM202RY): 6mL of VM202RY and VM202RY vehicle (total 12 site injections, low dose candidate-0.5mg VM202RY, 1mg VM202RY, 1.5mg VM202RY) Day 0 (Stage 2-High dose VM202RY): 6mL of VM202RY and VM202RY vehicle (total 12 site injections, high dose candidate-1mg VM202RY, 2mg VM202RY, 3mg VM202RY)|Day 0: 2mg of VM202RY (8 sites of 0.25mg/0.5mL VM202RY)|Day 0: 3mg of VM202RY (12 sites of 0.25mg/0.5mL VM202RY)|Day 0: 6mL of VM202RY vehicle (12 sites of 0.5mL 1.1% sucrose/0.9% NaCl)|Day 0: 6mL of VM202RY and VM202RY vehicle (total 12 site injections, low dose candidate-0.5mg VM202RY, 1mg VM202RY, 1.5mg VM202RY)|Day 0: 6mL of VM202RY and VM202RY vehicle (total 12 site injections, high dose candidate-1mg VM202RY, 2mg VM202RY, 3mg VM202RY)","DNA Plasmid | Hepatocyte growth factor (HGF)-X7|DNA Plasmid | HGF-X7|VM202RY vehicle | Sodium chloride, sucrose|DNA plasmid | HGF-X7","Stage 1-Low dose VM202RY|Stage 1-Middle dose VM202RY|Stage 1-High dose VM202RY|Stage 2-Placebo|Stage 2-Low dose VM202RY|Stage 2-High dose VM202RY","\n\n 1. Age â‰¥ 19 years to â‰¤ 75 years\n 2. Patients who underwent percutaneous coronary intervention (PCI) for the anterior wall infarction of left ventricle and had the elapsed time of 30 Â± 2 days from the PCI, regardless of success or failure of myocardial revascularization in the anterior wall\n 3. Patients with > 20% to â‰¤ 45% of left ventricular ejection fraction via trans-thoracic echocardiography within 7 days prior to the study drug or placebo injection\n 4. Left ventricular wall thickness â‰¥ 8 mm via trans-thoracic echocardiography (however, the subject shall be included if 50% or greater of the left ventricular anterior wall is â‰¥8mm or injection site other than the left ventricular anterior wall is â‰¥ 8mm.)\n 5. If female of childbearing potential, negative urine pregnancy test at screening and using acceptable method of birth control during the study; if male, using barrier method of birth control during study\n 6. Be capable of understanding and complying with the protocol and signing the informed consent document prior to being subjected to any study related procedures.\n\n","\n\n 1.  Severe systolic heart failure, NYHA Class III or IV\n 2.  New York Heart Association (NYHA) functional class IV\n 3.  History of recurrent ventricular tachycardia or cariogenic shock following PCI\n 4.  Stroke or transient ischemic attack (TIA) within 180 days\n 5.  Uncontrolled hypertension defined as systolic blood pressure â‰¥ 180 mmHg or diastolic â‰¥ 110 mmHg at screening and/or on the day of study drug or placebo injection\n 6.  Sustained ventricular tachyarrhythmia or recurrent ventricular tachycardia\n 7.  Implantation of automatic implantable cardioverter defibrillator (AICD)\n 8.  On extracorporeal membrane oxygenator (ECMO)\n 9.  History of ventricular fibrillation after PCI\n 10. Permanent pacemaker implantation (temporary pacemaker may be enrolled)\n 11. Subjects with aortic stenosis of moderate or greater degree, or with prosthetic aortic valve who may not be appropriate to use the C-CATHezÂ® catheter due to the risk of injury during the interventional procedure through the valve\n 12. Atherosclerotic or other disease of the aorto-iliac system that would impede the safe passage of the C-CATHezÂ®\n 13. Subjects with any serious comorbidities that the investigators deemed to be inappropriate to be enrolled\n 14. Patients with a recent history (< 5 years) of, or new screening finding of malignant neoplasm except basal cell carcinoma or squamous cell carcinoma of the skin (if excised and no evidence of recurrence); patients with family history of colon cancer in any first degree relative are excluded unless they have undergone a colonoscopy in the last 12 months with negative findings\n 15. Elevated prostate-specific antigen (PSA) despite not having prostate cancer history\n 16. Ophthalmologic conditions pertinent to proliferative retinopathy or conditions that preclude standard ophthalmologic examination Diagnosis of proliferative retinopathy or conditions that preclude standard ophthalmologic examination\n 17. Subjects currently receiving immunosuppressive medications, chemotherapy, or radiation therapy\n 18. Active infectious disease and/or positive Human Immunodeficiency Virus (HIV) or Human T-Cell lymphotropic viruses (HTLV) at screening\n 19. Active Hepatitis B or C infection as determined by Hepatitis B surface antibody (HBsAb), Hepatitis B core antibody (Immunoglobulin G and Immunoglobulin M; HBcAb), Hepatitis B surface antigen (HBsAg) and Hepatitis C antibodies (Anti-HCV) at screening\n 20. Specific laboratory values at screening including * Hemoglobin â‰¤ 9.0 g/dL, white blood cell (WBC) < 3,000 cells/Î¼l, platelet count < 75,000/mm3\n      * Creatinine > 2.0 mg/dL\n      * Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 3 x upper limit of normal (ULN)\n      * Any other clinically significant lab abnormality which in the opinion of the investigator should be exclusionary\n     \n     \n 21. Subjects requiring > 100 mg daily of acetylsalicylic acid (ASA); subjects may be enrolled if willing/able to switch to â‰¤ 100 mg daily of ASA or to another medication\n 22. Subjects regularly taking cyclooxygenase (COX)-2 inhibiting drug(s) or non-specific COX-1/COX-2 inhibiting drugs, or high dose steroids (except inhaled steroids); subjects may be enrolled if willing/able to undergo medication wash-out prior to the first dosing and to refrain from taking these drugs for the duration of the study, and also if the subject is temporarily taking NSAID (non-steroidal anti-inflammatory drug) temporarily (â‰¤ 7 days)\n 23. Patients that have undergone enhanced external pulsation (EECP) treatment within the last 6 months\n 24. Pregnancy or lactation\n 25. Severe comorbidity associated with a reduction of life expectancy of less than 1 year\n 26. Exposure to any previous experimental angiogenic therapy and/or myocardial laser therapy; or therapy with another investigational drug within 180 days of enrollment or participation in any concurrent study that may confound the results of this study\n 27. Major psychiatric disorder in the past 6 months\n 28. Known drug or alcohol dependence or any other factors which will interfere with the study conduct or interpretation of the results or who in the opinion of the investigator are not suitable to participate\n 29. Deemed to be in unsuitable condition by the study investigator",{"$nulls":4},"Actual","2018-01-19","Actual","Anticipated","2020-04-01","Anticipated","2019-10-01","2017-08-16","2018-01-18","2019-10-23","Yes","gene therapy","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","19 Years","75 Years","All",null,"No","No",{"$nulls":3},"No","No",{"$nulls":4},"Yes",{"$nulls":14},"Stage 1: MTD (maximum tolerated dose)|Stage 2: LVEF (left ventricular ejection fraction) measured by cardiac MRI","â€¢ MTD is defined as the dose level below the dose at which â‰¥ 33% of participants experienced DLT (dose limiting toxicity). The DLT assessment will be conducted on day 14. Toxicities more severe than grade 3 on the WHO toxicity scale will be designated as DLT. The dose where severe adverse events occur according to the Spilker classification will also be designated as DLT. The assessment will be conducted from the lowest dose to higher doses incrementally. MTD will be measured in milligrams (mg).|â€¢ The change in LVEF measured by cardiac MRI in VM202RY and placebo will be compared at 6 months after the treatment of VM202RY or Placebo by transendocardial injections using C-CATHezÂ® catheter. LVEF will be measured in percentage (%).","6 months","Change in left ventricular diameter (cardiac MRI)|Change in left ventricular diameter (TTE)|Change in left ventricular volume (cardiac MRI)|Change in left ventricular volume (TTE)|Change in cardiac output (cardiac MRI)|Change in cardiac output (TTE)|Change in LVEF (cardiac MRI)|Change in LVEF (TTE)|Change in wall motion score index (cardiac MRI)|Change in wall motion score index (TTE)|Change in myocardial wall thickness (cardiac MRI)|Change in extent of late enhancement of gadolinium (cardiac MRI)|Change in rest perfusion (cardiac MRI)|Change in rest perfusion (myocardial SPECT)|Change in stress perfusion (cardiac MRI)|Change in stress perfusion (myocardial SPECT)","The change in diameter of left ventricle will be measured in millimeters (mm), at months 3 and 6 using cardiac MRI.|The change in diameter of left ventricle will be measured in millimeters (mm), at months 3 and 6 using TTE (transthoracic echocardiogram).|The change in volume of left ventricle will be measured in milliliters (mL), at months 3 and 6 using cardiac MRI.|The change in volume of left ventricle will be measured in milliliters (mL), at months 3 and 6 using TTE.|The change in cardiac output will be measured in liters per minute (L/min), at months 3 and 6 using cardiac MRI.|The change in cardiac output will be measured in liters per minute (L/min), at months 3 and 6 using TTE.|The change in left ventricular ejection fraction will be measured in percentage (%), at months 3 and 6 using cardiac MRI.|The change in left ventricular ejection fraction will be measured in percentage (%), at months 3 and 6 using TTE.|The wall motion score index will be measured at months 3 and 6 using cardiac MRI.|The wall motion score index will be measured at months 3 and 6 using TTE.|The change in myocardial wall thickness of the investigational-product or placebo injected area will be measured in millimeters (mm) at months 3 and 6 using cardiac MRI.|The change in extent of late enhancement of gadolinium will be measured at months 3 and 6 using cardiac MRI.|The change in rest perfusion will be measured in percentage (%) at months 3 and 6 using cardiac MRI.|The change in rest perfusion will be measured in percentage (%) at months 3 and 6 using myocardial SPECT.|The change in stress perfusion will be measured in percentage (%) at months 3 and 6 using cardiac MRI.|The change in stress perfusion will be measured in percentage (%) at months 3 and 6 using myocardial SPECT.","3 and 6 months","hsyoon@viromed.co.kr","Hong Sik Yoon, PharmD","02-2102-7200",{"$nulls":8},"2019-10-23","2020-05-25T16:37:35.695","2020-05-26T17:10:42.972","NCT03404024"]
["5ecbf450fe30261b1a0482c4","NCT03404115","2018-03-30","Aldeyra","ALDX","Recruiting","A Multi-Center, Randomized, Double Masked, Parallel-Group, Vehicle-Controlled, Clinical Study to Assess the Safety and Efficacy of Reproxalap Ophthalmic Solution in Subjects With Dry Eye Disease","Adx-102",null,"Yes","['Adx-102']","Unknown",null,"Phase 2",3,300,"Anticipated","2018-01-02","2018-09-01",{"$nulls":5},"A Multi-Center, Phase 2b, Randomized, Double Masked, Parallel-Group, Vehicle-Controlled, Clinical Study to Assess the Safety and Efficacy of Reproxalap Ophthalmic Solution (0.25% and 0.1%) Compared to Vehicle in Subjects with Dry Eye Disease",null,"A Multi-Center, Phase 2b, Randomized, Double Masked, Parallel-Group, Vehicle-Controlled, Clinical Study to Assess the Safety and Efficacy of Reproxalap Ophthalmic Solution (0.25% and 0.1%) Compared to Vehicle in Subjects With Dry Eye Disease","ADX-102-DED-009","Dry Eye Syndrome","Keratoconjunctivitis Sicca|Dry Eye Syndromes","Conjunctival Diseases|Lacrimal Apparatus Diseases","Ophthalmological","Experimental|Placebo Comparator","Reproxalap Ophthalmic Solution (0.25%)|Reproxalap Ophthalmic Solution (0.1%)|Vehicle Ophthalmic Solution",null,"Drug","Reproxalap Ophthalmic Solution (0.25%)|Reproxalap Ophthalmic Solution (0.1%)|Vehicle Ophthalmic Solution","Reproxalap Ophthalmic Solution (0.25%) administered for approximately twelve weeks.|Reproxalap Ophthalmic Solution (0.1%) administered for approximately twelve weeks.|Vehicle Ophthalmic Solution administered for approximately twelve weeks.",null,"Reproxalap Ophthalmic Solution (0.25%)|Reproxalap Ophthalmic Solution (0.1%)|Vehicle Ophthalmic Solution","\n\n * Be at least 18 years of age of either gender and any race;\n * Have a reported history of dry eye for at least 6 months prior to Visit 1;\n * Have a history of use or desire to use eye drops for dry eye symptoms within 6 months of Visit 1;\n\n","\n\n * Have any clinically significant slit lamp findings at Visit 1 that may include active blepharitis, meibomian gland dysfunction (MGD), lid margin inflammation, or active ocular allergies that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters;\n * Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1;\n * Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the study;\n * Have used any eye drops within 2 hours of Visit 1;\n * Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months;\n * Have used cyclosporine 0.05% or lifitigrast 5.0% ophthalmic solution within 90 days of Visit 1;\n * Have any planned ocular and/or lid surgeries over the study period or any ocular surgery within 6 months of Visit 1;\n * Be using or anticipate using temporary punctal plugs during the study that have not been stable within 30 days of Visit 1;",{"$nulls":4},"Actual","2018-01-19","Actual","Anticipated","2018-09-01","Anticipated","2018-01-01","2018-01-12","2018-01-12","2018-03-29","No","reproxalap","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"All",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":19},"Assess safety and tolerability of reproxalap formulations using adverse event query.","Evaluate the safety and tolerability of reproxalap formulations in subjects with dry eye syndrome","Safety Assessment Period (Day -14 to Day 85)","Efficacy of reproxalap on Lissamine green staining using the Ora CalibraÂ® scale.|Efficacy of reproxalap on fluorescein staining using the Ora CalibraÂ® scale.|Efficacy of reproxalap on tear film break-up time (TFBUTÂ©).|Efficacy of reproxalap on ocular discomfort using the Ora CalibraÂ® Ocular Discomfort scale|Efficacy of reproxalap on dry eye syndrome using the Ocular Surface and Disease Index (OSDI) Â© questionnaire.|Efficacy of reproxalap on dry eye syndrome symptoms using the Symptom Assessment in Dry Eye (SANDE) scale.","Evaluate lissamine green staining of reproxalap in subjects with dry eye syndrome.|Evaluate fluorescein staining of reproxalap in subjects with dry eye syndrome.|Evaluate tear film break-up time of reproxalap in subjects with dry eye syndrome.|Evaluate the symptoms of reproxalap on ocular discomfort in subjects with dry eye syndrome|Evaluate the symptoms of reproxalp in subjects with dry eye syndrome.|Evaluate the dry eye symptoms of reproxalap in subjects with dry eye syndrome.","Efficacy assessment period (Day 1 through Day 85)","bcavanagh@aldeyra.com","Bill Cavanagh","781-761-4904 Ext. 210","Indianapolis, Indiana, United States, 46290|Lewiston, Maine, United States, 04240|Andover, Massachusetts, United States, 01810|Memphis, Tennessee, United States, 38119","Indiana|Maine|Massachusetts|Tennessee","United States","Midwest Cornea Associates|Central Maine Eye Care|Andover Eye Associates|Total Eye Care",{"$nulls":4},"2018-03-29","2020-05-25T16:37:36.062","2020-05-26T17:10:42.972","NCT03404115"]
["5ecbf450e2561b1b11905dc0","NCT03404115","2018-08-02","Aldeyra","ALDX","Active, not recruiting","A Multi-Center, Randomized, Double Masked, Parallel-Group, Vehicle-Controlled, Clinical Study to Assess the Safety and Efficacy of Reproxalap Ophthalmic Solution in Subjects With Dry Eye Disease","Adx-102",null,"Yes","['Adx-102']","Unknown",null,"Phase 2",3,300,"Actual","2018-01-02","2018-09-01",{"$nulls":5},"A Multi-Center, Phase 2b, Randomized, Double Masked, Parallel-Group, Vehicle-Controlled, Clinical Study to Assess the Safety and Efficacy of Reproxalap Ophthalmic Solution (0.25% and 0.1%) Compared to Vehicle in Subjects with Dry Eye Disease",null,"A Multi-Center, Phase 2b, Randomized, Double Masked, Parallel-Group, Vehicle-Controlled, Clinical Study to Assess the Safety and Efficacy of Reproxalap Ophthalmic Solution (0.25% and 0.1%) Compared to Vehicle in Subjects With Dry Eye Disease","ADX-102-DED-009","Dry Eye Syndrome","Keratoconjunctivitis Sicca|Dry Eye Syndromes","Conjunctival Diseases|Lacrimal Apparatus Diseases","Ophthalmological","Experimental|Placebo Comparator","Reproxalap Ophthalmic Solution (0.25%)|Reproxalap Ophthalmic Solution (0.1%)|Vehicle Ophthalmic Solution",null,"Drug","Reproxalap Ophthalmic Solution (0.25%)|Reproxalap Ophthalmic Solution (0.1%)|Vehicle Ophthalmic Solution","Reproxalap Ophthalmic Solution (0.25%) administered for approximately twelve weeks.|Reproxalap Ophthalmic Solution (0.1%) administered for approximately twelve weeks.|Vehicle Ophthalmic Solution administered for approximately twelve weeks.",null,"Reproxalap Ophthalmic Solution (0.25%)|Reproxalap Ophthalmic Solution (0.1%)|Vehicle Ophthalmic Solution","\n\n * Be at least 18 years of age of either gender and any race;\n * Have a reported history of dry eye for at least 6 months prior to Visit 1;\n * Have a history of use or desire to use eye drops for dry eye symptoms within 6 months of Visit 1;\n\n","\n\n * Have any clinically significant slit lamp findings at Visit 1 that may include active blepharitis, meibomian gland dysfunction (MGD), lid margin inflammation, or active ocular allergies that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters;\n * Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1;\n * Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the study;\n * Have used any eye drops within 2 hours of Visit 1;\n * Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months;\n * Have used cyclosporine 0.05% or lifitigrast 5.0% ophthalmic solution within 90 days of Visit 1;\n * Have any planned ocular and/or lid surgeries over the study period or any ocular surgery within 6 months of Visit 1;\n * Be using or anticipate using temporary punctal plugs during the study that have not been stable within 30 days of Visit 1;",{"$nulls":4},"Actual","2018-01-19","Actual","Anticipated","2018-09-01","Anticipated","2018-01-01","2018-01-12","2018-01-12","2018-08-01","No","reproxalap","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"All",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":19},"Assess safety and tolerability of reproxalap formulations using adverse event query.","Evaluate the safety and tolerability of reproxalap formulations in subjects with dry eye syndrome.","Safety Assessment Period (Day -14 to Day 85)","Efficacy of reproxalap on Lissamine green staining using the Ora CalibraÂ® scale.|Efficacy of reproxalap on fluorescein staining using the Ora CalibraÂ® scale.|Efficacy of reproxalap on tear film break-up time (TFBUTÂ©).|Efficacy of reproxalap on ocular discomfort using the Ora CalibraÂ® Ocular Discomfort scale.|Efficacy of reproxalap on dry eye syndrome using the Ocular Surface and Disease Index (OSDI) Â© questionnaire.|Efficacy of reproxalap on dry eye syndrome symptoms using the Symptom Assessment in Dry Eye (SANDE) scale.","Evaluate lissamine green staining of reproxalap in subjects with dry eye syndrome.|Evaluate fluorescein staining of reproxalap in subjects with dry eye syndrome.|Evaluate tear film break-up time of reproxalap in subjects with dry eye syndrome.|Evaluate the symptoms of reproxalap on ocular discomfort in subjects with dry eye syndrome.|Evaluate the symptoms of reproxalp in subjects with dry eye syndrome.|Evaluate the dry eye symptoms of reproxalap in subjects with dry eye syndrome.","Efficacy assessment period (Day 1 through Day 85)",{"$nulls":3},"Waterbury, Connecticut, United States, 06708|Indianapolis, Indiana, United States, 46290|Lewiston, Maine, United States, 04240|Andover, Massachusetts, United States, 01810 Andover Eye AssociatesRaynham, Massachusetts, United States, 02767|Memphis, Tennessee, United States, 38119","Connecticut|Indiana|Maine|Massachusetts|Tennessee","United States","The Eye Care Group|Midwest Cornea Associates|Central Maine Eye Care|Andover Eye Associates|Total Eye Care",{"$nulls":4},"2018-08-01","2020-05-25T16:37:36.326","2020-05-26T17:10:42.972","NCT03404115"]
["5ecbf450feab101b155308f5","NCT03404115","2018-10-16","Aldeyra","ALDX","Completed","A Multi-Center, Randomized, Double Masked, Parallel-Group, Vehicle-Controlled, Clinical Study to Assess the Safety and Efficacy of Reproxalap Ophthalmic Solution in Subjects With Dry Eye Disease","Adx-102",null,"Yes","['Adx-102']","Unknown",null,"Phase 2",3,300,"Actual","2018-01-02","2018-07-11",{"$nulls":5},"A Multi-Center, Phase 2b, Randomized, Double Masked, Parallel-Group, Vehicle-Controlled, Clinical Study to Assess the Safety and Efficacy of Reproxalap Ophthalmic Solution (0.25% and 0.1%) Compared to Vehicle in Subjects with Dry Eye Disease",null,"A Multi-Center, Phase 2b, Randomized, Double Masked, Parallel-Group, Vehicle-Controlled, Clinical Study to Assess the Safety and Efficacy of Reproxalap Ophthalmic Solution (0.25% and 0.1%) Compared to Vehicle in Subjects With Dry Eye Disease","ADX-102-DED-009","Dry Eye Syndrome","Keratoconjunctivitis Sicca|Dry Eye Syndromes","Conjunctival Diseases|Lacrimal Apparatus Diseases","Ophthalmological","Experimental|Placebo Comparator","Reproxalap Ophthalmic Solution (0.25%)|Reproxalap Ophthalmic Solution (0.1%)|Vehicle Ophthalmic Solution",null,"Drug","Reproxalap Ophthalmic Solution (0.25%)|Reproxalap Ophthalmic Solution (0.1%)|Vehicle Ophthalmic Solution","Reproxalap Ophthalmic Solution (0.25%) administered for approximately twelve weeks.|Reproxalap Ophthalmic Solution (0.1%) administered for approximately twelve weeks.|Vehicle Ophthalmic Solution administered for approximately twelve weeks.",null,"Reproxalap Ophthalmic Solution (0.25%)|Reproxalap Ophthalmic Solution (0.1%)|Vehicle Ophthalmic Solution","\n\n * Be at least 18 years of age of either gender and any race;\n * Have a reported history of dry eye for at least 6 months prior to Visit 1;\n * Have a history of use or desire to use eye drops for dry eye symptoms within 6 months of Visit 1;\n\n","\n\n * Have any clinically significant slit lamp findings at Visit 1 that may include active blepharitis, meibomian gland dysfunction (MGD), lid margin inflammation, or active ocular allergies that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters;\n * Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1;\n * Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the study;\n * Have used any eye drops within 2 hours of Visit 1;\n * Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months;\n * Have used cyclosporine 0.05% or lifitigrast 5.0% ophthalmic solution within 90 days of Visit 1;\n * Have any planned ocular and/or lid surgeries over the study period or any ocular surgery within 6 months of Visit 1;\n * Be using or anticipate using temporary punctal plugs during the study that have not been stable within 30 days of Visit 1;",{"$nulls":4},"Actual","2018-01-19","Actual","Actual","2018-07-11","Actual","2018-01-01","2018-01-12","2018-01-12","2018-10-15","No","reproxalap","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"All",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":19},"Assess safety and tolerability of reproxalap formulations using adverse event query.","Evaluate the safety and tolerability of reproxalap formulations in subjects with dry eye syndrome.","Safety Assessment Period (Day -14 to Day 85)","Efficacy of reproxalap on Lissamine green staining using the Ora CalibraÂ® scale.|Efficacy of reproxalap on fluorescein staining using the Ora CalibraÂ® scale.|Efficacy of reproxalap on tear film break-up time (TFBUTÂ©).|Efficacy of reproxalap on ocular discomfort using the Ora CalibraÂ® Ocular Discomfort scale.|Efficacy of reproxalap on dry eye syndrome using the Ocular Surface and Disease Index (OSDI) Â© questionnaire.|Efficacy of reproxalap on dry eye syndrome symptoms using the Symptom Assessment in Dry Eye (SANDE) scale.","Evaluate lissamine green staining of reproxalap in subjects with dry eye syndrome.|Evaluate fluorescein staining of reproxalap in subjects with dry eye syndrome.|Evaluate tear film break-up time of reproxalap in subjects with dry eye syndrome.|Evaluate the symptoms of reproxalap on ocular discomfort in subjects with dry eye syndrome.|Evaluate the symptoms of reproxalp in subjects with dry eye syndrome.|Evaluate the dry eye symptoms of reproxalap in subjects with dry eye syndrome.","Efficacy assessment period (Day 1 through Day 85)",{"$nulls":3},"Waterbury, Connecticut, United States, 06708|Indianapolis, Indiana, United States, 46290|Lewiston, Maine, United States, 04240|Andover, Massachusetts, United States, 01810 Andover Eye AssociatesRaynham, Massachusetts, United States, 02767|Memphis, Tennessee, United States, 38119","Connecticut|Indiana|Maine|Massachusetts|Tennessee","United States","The Eye Care Group|Midwest Cornea Associates|Central Maine Eye Care|Andover Eye Associates|Total Eye Care",{"$nulls":4},"2018-10-15","2020-05-25T16:37:36.341","2020-05-26T17:10:42.972","NCT03404115"]
["5ecbf451fe30261b1a0482c6","NCT03404206","2018-03-14","Bayer","BAYN","Recruiting","A Trial to Compare the Duration of Analgesic Efficacy and Safety of Naproxen Sodium Tablets and Ibuprofen Tablets in Postsurgical Dental Pain","Naproxen|Ibuprofen","COX Inhibitor|COX2 Inhibitor","No",null,"No",null,"Phase 4",3,385,"Anticipated","2018-02-07","2018-09-05",{"$nulls":5},"To compare the duration of analgesic efficacy as determined by the time to rescue medication of a single oral dose of naproxen sodium 440 mg (2 x 220 mg tablets) relative to ibuprofen 400 mg (2 x 200 mg tablets) and placebo over 24 hours in subjects experiencing moderate to severe post-impaction surgery dental pain.\n\nTo compare the overall analgesic effect (SPID 0-24) of a single dose of naproxen sodium 440 mg (2 x 220 mg tablets) relative to ibuprofen 400 mg (2 x 200 mg tablets) and placebo.\n\nTo compare the overall relief from pain (TOTPAR 0-24) of a single dose of naproxen sodium 440 mg (2 x 220 mg tablets) relative to ibuprofen 400 mg (2 x 200 mg tablets) and placebo.",null,"A Randomized, Double-Blind, Placebo-Controlled Trial to Compare the Duration of Analgesic Efficacy and Safety of Naproxen Sodium Tablets and Ibuprofen Tablets in Postsurgical Dental Pain",19762,"Pain, Postoperative","Pain, Postoperative","Neurologic Manifestations","Central Nervous System","Experimental|Active Comparator|Placebo Comparator","Naproxen Sodium (Aleve, BAY117031)|Ibuprofen (Advil)|Placebo","3/7 subjects receive total dose of 440mg Naproxen sodium (220 mg Naproxen Sodium/ orally, 2 tablets), single dose|3/7 subjects receive total dose of 400mg Ibuprofen (200 mg Ibuprofen/ orally, 2 tablets), single dose|1/7 subjects receive placebo orally, 2 tablets, single dose","Drug","Naproxen Sodium (Aleve, BAY117031)|Ibuprofen (Advil)|Placebo","220 mg / orally, 2 tablets, single dose|200 mg / orally, 2 tablets, single dose|Orally, 2 tablets, single dose",null,"Naproxen Sodium (Aleve, BAY117031)|Ibuprofen (Advil)|Placebo","\n\n * Healthy, ambulatory, male or female volunteers 16-40 years of age;\n * Body mass index 18.0 to 30.0 kg/m2 inclusive;\n * Scheduled to undergo surgical removal of at least 2 mandibular partial or full bony impacted third molars. Up to two maxillary third molars may be removed regardless of impaction level. Supernumerary teeth present may also be removed at the discretion of the oral surgeon;\n * Mandibular molars must demonstrate modified Demirjian root classification stage D, E, F, G or H;\n\n","\n\n * History of hypersensitivity to naproxen sodium, ibuprofen, NSAIDS, aspirin, similar pharmacological agents, local anesthetics, rescue medication or components of the investigational products;\n * Evidence or history of clinically significant (in the judgment of the investigator) hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic diseases, or malignancies within the last 5 years;\n * Relevant concomitant disease such as asthma (exercise induced asthma is permitted)",{"$nulls":4},"Actual","2018-01-19","Actual","Anticipated","2018-09-05","Anticipated","2018-03-01","2018-01-12","2018-01-12","2018-03-13","No","Postsurgical pain","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","16 Years","40 Years","All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":4},"Yes",{"$nulls":12},"2017-005049-67","EudraCT Number","Time to First Use of Rescue Medication","To compare the duration of analgesic efficacy of test products as determined by the time to rescue medication","Up to 24 hours","SPID (Summed Pain Intensity Difference)|TOTPAR (Total Pain Relief)","Up to 24 hours",{"$nulls":4},"Salt Lake City, Utah, United States, 84124","Utah","United States","Jean Brown Research",{"$nulls":4},"2018-03-13","2020-05-25T16:37:37.026","2020-05-26T17:10:42.972","NCT03404206"]
["5ecbf451e2561b1b11905dc2","NCT03404206","2018-04-13","Bayer","BAYN","Recruiting","A Trial to Compare the Duration of Analgesic Efficacy and Safety of Naproxen Sodium Tablets and Ibuprofen Tablets in Postsurgical Dental Pain","Naproxen|Ibuprofen","COX Inhibitor|COX2 Inhibitor","No",null,"No",null,"Phase 4",3,385,"Anticipated","2018-02-12","2018-09-05",{"$nulls":5},"To compare the duration of analgesic efficacy as determined by the time to rescue medication of a single oral dose of naproxen sodium 440 mg (2 x 220 mg tablets) relative to ibuprofen 400 mg (2 x 200 mg tablets) and placebo over 24 hours in subjects experiencing moderate to severe post-impaction surgery dental pain.\n\nTo compare the overall analgesic effect (SPID 0-24) of a single dose of naproxen sodium 440 mg (2 x 220 mg tablets) relative to ibuprofen 400 mg (2 x 200 mg tablets) and placebo.\n\nTo compare the overall relief from pain (TOTPAR 0-24) of a single dose of naproxen sodium 440 mg (2 x 220 mg tablets) relative to ibuprofen 400 mg (2 x 200 mg tablets) and placebo.",null,"A Randomized, Double-Blind, Placebo-Controlled Trial to Compare the Duration of Analgesic Efficacy and Safety of Naproxen Sodium Tablets and Ibuprofen Tablets in Postsurgical Dental Pain",19762,"Pain, Postoperative","Pain, Postoperative","Neurologic Manifestations","Central Nervous System","Experimental|Active Comparator|Placebo Comparator","Naproxen Sodium (Aleve, BAY117031)|Ibuprofen (Advil)|Placebo","3/7 subjects receive total dose of 440mg Naproxen sodium (220 mg Naproxen Sodium/ orally, 2 tablets), single dose|3/7 subjects receive total dose of 400mg Ibuprofen (200 mg Ibuprofen/ orally, 2 tablets), single dose|1/7 subjects receive placebo orally, 2 tablets, single dose","Drug","Naproxen Sodium (Aleve, BAY117031)|Ibuprofen (Advil)|Placebo","220 mg / orally, 2 tablets, single dose|200 mg / orally, 2 tablets, single dose|Orally, 2 tablets, single dose",null,"Naproxen Sodium (Aleve, BAY117031)|Ibuprofen (Advil)|Placebo","\n\n * Healthy, ambulatory, male or female volunteers 16-40 years of age;\n * Body mass index 18.0 to 30.0 kg/m2 inclusive;\n * Scheduled to undergo surgical removal of at least 2 mandibular partial or full bony impacted third molars. Up to two maxillary third molars may be removed regardless of impaction level. Supernumerary teeth present may also be removed at the discretion of the oral surgeon;\n * Mandibular molars must demonstrate modified Demirjian root classification stage D, E, F, G or H;\n\n","\n\n * History of hypersensitivity to naproxen sodium, ibuprofen, NSAIDS, aspirin, similar pharmacological agents, local anesthetics, rescue medication or components of the investigational products;\n * Evidence or history of clinically significant (in the judgment of the investigator) hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic diseases, or malignancies within the last 5 years;\n * Relevant concomitant disease such as asthma (exercise induced asthma is permitted)",{"$nulls":4},"Actual","2018-01-19","Actual","Anticipated","2018-09-05","Anticipated","2018-04-01","2018-01-12","2018-01-12","2018-04-12","No","Postsurgical pain","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","16 Years","40 Years","All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":4},"Yes",{"$nulls":12},"2017-005049-67","EudraCT Number","Time to First Use of Rescue Medication","To compare the duration of analgesic efficacy of test products as determined by the time to rescue medication","Up to 24 hours","SPID (Summed Pain Intensity Difference)|TOTPAR (Total Pain Relief)","Up to 24 hours",{"$nulls":4},"Salt Lake City, Utah, United States, 84124","Utah","United States","Jean Brown Research",{"$nulls":4},"2018-04-12","2020-05-25T16:37:37.098","2020-05-26T17:10:42.972","NCT03404206"]
["5ecbf45111702c1b1b916ad6","NCT03404206","2018-08-03","Bayer","BAYN","Completed","A Trial to Compare the Duration of Analgesic Efficacy and Safety of Naproxen Sodium Tablets and Ibuprofen Tablets in Postsurgical Dental Pain","Naproxen|Ibuprofen","COX Inhibitor|COX2 Inhibitor","No",null,"No",null,"Phase 4",3,400,"Actual","2018-02-12","2018-07-06",{"$nulls":5},"To compare the duration of analgesic efficacy as determined by the time to rescue medication of a single oral dose of naproxen sodium 440 mg (2 x 220 mg tablets) relative to ibuprofen 400 mg (2 x 200 mg tablets) and placebo over 24 hours in subjects experiencing moderate to severe post-impaction surgery dental pain.\n\nTo compare the overall analgesic effect (SPID 0-24) of a single dose of naproxen sodium 440 mg (2 x 220 mg tablets) relative to ibuprofen 400 mg (2 x 200 mg tablets) and placebo.\n\nTo compare the overall relief from pain (TOTPAR 0-24) of a single dose of naproxen sodium 440 mg (2 x 220 mg tablets) relative to ibuprofen 400 mg (2 x 200 mg tablets) and placebo.",null,"A Randomized, Double-Blind, Placebo-Controlled Trial to Compare the Duration of Analgesic Efficacy and Safety of Naproxen Sodium Tablets and Ibuprofen Tablets in Postsurgical Dental Pain",19762,"Pain, Postoperative","Pain, Postoperative","Neurologic Manifestations","Central Nervous System","Experimental|Active Comparator|Placebo Comparator","Naproxen Sodium (Aleve, BAY117031)|Ibuprofen (Advil)|Placebo","3/7 subjects receive total dose of 440mg Naproxen sodium (220 mg Naproxen Sodium/ orally, 2 tablets), single dose|3/7 subjects receive total dose of 400mg Ibuprofen (200 mg Ibuprofen/ orally, 2 tablets), single dose|1/7 subjects receive placebo orally, 2 tablets, single dose","Drug","Naproxen Sodium (Aleve, BAY117031)|Ibuprofen (Advil)|Placebo","220 mg / orally, 2 tablets, single dose|200 mg / orally, 2 tablets, single dose|Orally, 2 tablets, single dose",null,"Naproxen Sodium (Aleve, BAY117031)|Ibuprofen (Advil)|Placebo","\n\n * Healthy, ambulatory, male or female volunteers 16-40 years of age;\n * Body mass index 18.0 to 30.0 kg/m2 inclusive;\n * Scheduled to undergo surgical removal of at least 2 mandibular partial or full bony impacted third molars. Up to two maxillary third molars may be removed regardless of impaction level. Supernumerary teeth present may also be removed at the discretion of the oral surgeon;\n * Mandibular molars must demonstrate modified Demirjian root classification stage D, E, F, G or H;\n\n","\n\n * History of hypersensitivity to naproxen sodium, ibuprofen, NSAIDS, aspirin, similar pharmacological agents, local anesthetics, rescue medication or components of the investigational products;\n * Evidence or history of clinically significant (in the judgment of the investigator) hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic diseases, or malignancies within the last 5 years;\n * Relevant concomitant disease such as asthma (exercise induced asthma is permitted)",{"$nulls":4},"Actual","2018-01-19","Actual","Actual","2018-07-06","Actual","2018-08-01","2018-01-12","2018-01-12","2018-08-02","No","Postsurgical pain","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","16 Years","40 Years","All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":4},"Yes",{"$nulls":12},"2017-005049-67","EudraCT Number","Time to First Use of Rescue Medication","To compare the duration of analgesic efficacy of test products as determined by the time to rescue medication","Up to 24 hours","SPID (Summed Pain Intensity Difference)|TOTPAR (Total Pain Relief)","Up to 24 hours",{"$nulls":4},"Salt Lake City, Utah, United States, 84124","Utah","United States","Jean Brown Research",{"$nulls":4},"2018-08-02","2020-05-25T16:37:37.128","2020-05-26T17:10:42.972","NCT03404206"]
["5ecbf452fe30261b1a0482c9","NCT03404726","2018-01-19","Bayer","BAYN","Not yet recruiting","A Study to Investigate BAY2402234, a Dihydroorotate Dehydrogenase (DHODH) Inhibitor, in Myeloid Malignancies","Bay-2402234","DHODH Inhibitor","Yes","['Bay-2402234']","No",null,"Phase 1",3,120,"Anticipated","2018-03-30","2020-09-25","MTD|AUC","Maximum Tolerated Dose|Area Under The Curve",{"$nulls":3},"To determine the safety, tolerability, pharmacokinetics, maximum tolerated dose, or pharmacological active dose of BAY2402234 in patients with acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), or chronic myelomonocytic leukemia (CMML)",null,"An Open-label, Multicenter Phase 1 Study to Characterize the Safety, Tolerability, Preliminary Antileukemic Activity, Pharmacokinetics, and Maximum Tolerated Dose or Pharmacological Active Dose of BAY2402234 in Patients With Advanced Myeloid Malignancies",19420,"Leukemia","Leukemia","Oncology Hematological","Oncology","Experimental","BAY2402234/ Dose Escalation|BAY2402234/ Dose Expansion: AML|BAY2402234/ Dose Expansion: MDS","Dose escalation with sequential cohorts enrolling patients with AML, MDS, or CMML. Patients will be treated in 28-day cycles with once daily oral administration of BAY2402234|After completion of dose escalation, an expansion cohort comprised of patients with AML will start. These patients will be treated in 28 day cycles with once daily oral administration of BAY2402234 at the maximum tolerated dose or pharmacologically active dose.|After completion of dose escalation, an expansion cohort comprised of patients with MDS will start. These patients will be treated in 28 day cycles with once daily oral administration of BAY2402234 at the maximum tolerated dose or pharmacologically active dose.","Drug","BAY2402234","BAY2402234 is a potent and selective small molecule inhibitor of dihydroorotate dehydrogenase. A solution of BAY2402234 will be available to initiate the trial and there are plans to transition to a tablet form of BAY2402234 once it becomes available. Both liquid and tablet formulations of BAY2402234 will be continually administered once daily by mouth in 28 day cycles.",null,"BAY2402234/ Dose Escalation|BAY2402234/ Dose Expansion: AML|BAY2402234/ Dose Expansion: MDS","\n\n * Patients with relapsed or refractory AML. Relapsed AML is defined as relapse after achieving a response to initial therapy and refractory AML is defined as failure to achieve a response after one previous line of therapy. Response is defined as per IWG criteria (CR, CRi or CRp). Patients who are not candidates to receive or who decline standard of care therapy are also eligible.\n * Patients with intermediate-1 or higher risk MDS who have failed therapy with a hypomethylating agent, or have failed lenalidomide therapy if harboring a 5qchromosomal deletion.\n * Patients with relapsed/refractory CMML.\n * Estimated glomerular filtration rate (eGFR) > 40 mL per 1.73 m*2\n * Patients must have adequate coagulation (international normalized ratio [INR] â‰¤ 1.5, activated partial thromboplastin time [aPTT] â‰¤1.5 X the upper limit of normal [ULN])\n * Adequate liver function (total bilirubin â‰¤1.5 X ULN (or â‰¤3 X ULN in patients with documented Gilbert's syndrome or for patients with hyperbilirubinemia considered due to myeloid disease), alanine aminotransferase [ALT] and aspartate aminotransferase [AST] â‰¤3 X ULN (or â‰¤5 X ULN for patients with liver involvement of their myeloid disease)\n\n","\n\nPatients eligible for hematopoietic stem cell transplantation:\n\n * Clinical symptoms suggesting active central nervous system (CNS) leukemia or known CNS leukemia\n * Human immunodeficiency virus (HIV) infection if not controlled by antiretroviral (ART) therapy and have CD4 count below 250 cell/mm*3\n * Chronic or active hepatitis B or C if not controlled by antiviral therapy\n * History of organ allograft (allogeneic bone marrow or stem cell transplant) within 4 months prior to first dose of study drug\n * Serious, uncontrolled infection requiring systemic antibiotic, antifungal or antiviral therapy. Prophylactic antibiotic, antifungal and/or antiviral therapy is permitted\n * Left ventricular ejection fraction (LVEF) <40%","CRP|EGFR","C-reactive protein|epidermal growth factor receptor","Protein","Breast|Ovary, Breast, Lung","Actual","2018-01-19","Actual","Anticipated","2020-09-25","Anticipated","2017-12-01","2017-11-29","2018-01-12","2018-01-12","No","Acute myeloid leukemia\nMyelodysplastic Syndromes\nChronic myelomonocytic leukemia\nDihydroorotate dehydrogenase (DHODH) inhibitor","Interventional","Treatment","Single Group Assignment","None (Open Label)","Non-Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"2017-002896-24","EudraCT Number","Maximum tolerated dose|Number of Adverse Events as a measure of safety and tolerability|AUC (0-24) (Area under the curve)|Cmax (Maximum concentration)","Phase 1 dose escalation study with increasing doses of study drug (BAY2402234). Maximum tolerated dose will be defined as the maximum dose administered during Cycle 1 at which the incidence of dose limiting toxicities is below 30%|Up to 6 months on average|Pre-dose, 0.5, 1, 2, 4, 6, 8, 12 hours after dose administration at Cycle 1 Day 1 and Cycle 1 Day 15","Up to 42 days after the first dose","Composite endpoint: Number of AML patients with complete remission (CR) and complete response with partial recovery of peripheral blood counts (CRh)|Change in in erythroid response as Histological Improvement criteria for patient with MDS and CMML|Change in platelet response as Histological Improvement criteria for patients with MDS and CMML|Change in neutrophil response as Histological Improvement criteria for patients with MDS and CMML","Response criteria according to modified IWG 2003. CRh is defined as <5% of blasts in the bone marrow, no evidence of disease, and partial recovery of peripheral blood counts (platelets >50,000/microliter and ANC >500/microliter)|Response criteria according to IWG 2006.","Up to 6 months on average|Every month until disease progression or patient is withdrawn from study, up to 6 months on average",{"$nulls":3},"Villejuif Cedex, France, 94805",null,"France","Institut Gustave Roussy - Villejuif",{"$nulls":4},"2018-01-12","2020-05-25T16:37:38.185","2020-05-26T17:10:42.972","NCT03404726"]
["5ecbf452e2561b1b11905dc5","NCT03404726","2018-04-05","Bayer","BAYN","Recruiting","A Study to Investigate BAY2402234, a Dihydroorotate Dehydrogenase (DHODH) Inhibitor, in Myeloid Malignancies","Bay-2402234","DHODH Inhibitor","Yes","['Bay-2402234']","No",null,"Phase 1",3,120,"Anticipated","2018-03-29","2020-09-25","MTD|AUC","Maximum Tolerated Dose|Area Under The Curve",{"$nulls":3},"To determine the safety, tolerability, pharmacokinetics, maximum tolerated dose, or pharmacological active dose of BAY2402234 in patients with acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), or chronic myelomonocytic leukemia (CMML)",null,"An Open-label, Multicenter Phase 1 Study to Characterize the Safety, Tolerability, Preliminary Antileukemic Activity, Pharmacokinetics, and Maximum Tolerated Dose or Pharmacological Active Dose of BAY2402234 in Patients With Advanced Myeloid Malignancies",19420,"Leukemia","Leukemia","Oncology Hematological","Oncology","Experimental","BAY2402234/ Dose Escalation|BAY2402234/ Dose Expansion: AML|BAY2402234/ Dose Expansion: MDS","Dose escalation with sequential cohorts enrolling patients with AML, MDS, or CMML. Patients will be treated in 28-day cycles with once daily oral administration of BAY2402234|After completion of dose escalation, an expansion cohort comprised of patients with AML will start. These patients will be treated in 28 day cycles with once daily oral administration of BAY2402234 at the maximum tolerated dose or pharmacologically active dose.|After completion of dose escalation, an expansion cohort comprised of patients with MDS will start. These patients will be treated in 28 day cycles with once daily oral administration of BAY2402234 at the maximum tolerated dose or pharmacologically active dose.","Drug","BAY2402234","BAY2402234 is a potent and selective small molecule inhibitor of dihydroorotate dehydrogenase. A solution of BAY2402234 will be available to initiate the trial and there are plans to transition to a tablet form of BAY2402234 once it becomes available. Both liquid and tablet formulations of BAY2402234 will be continually administered once daily by mouth in 28 day cycles.",null,"BAY2402234/ Dose Escalation|BAY2402234/ Dose Expansion: AML|BAY2402234/ Dose Expansion: MDS","\n\n * Patients with relapsed or refractory AML. Relapsed AML is defined as relapse after achieving a response to initial therapy and refractory AML is defined as failure to achieve a response after one previous line of therapy. Response is defined as per IWG criteria (CR, CRi or CRp). Patients who are not candidates to receive or who decline standard of care therapy are also eligible.\n * Patients with intermediate-1 or higher risk MDS who have failed therapy with a hypomethylating agent, or have failed lenalidomide therapy if harboring a 5q-chromosomal deletion.\n * Patients with relapsed/refractory CMML.\n * Estimated glomerular filtration rate (eGFR) > 40 mL per 1.73 m*2\n * Patients must have adequate coagulation (international normalized ratio [INR] â‰¤ 1.5, activated partial thromboplastin time [aPTT] â‰¤1.5 X the upper limit of normal [ULN])\n * Adequate liver function (total bilirubin â‰¤1.5 X ULN (or â‰¤3 X ULN in patients with documented Gilbert's syndrome or for patients with hyperbilirubinemia considered due to myeloid disease), alanine aminotransferase [ALT] and aspartate aminotransferase [AST] â‰¤3 X ULN (or â‰¤5 X ULN for patients with liver involvement of their myeloid disease)\n\n","\n\n * Patients eligible for hematopoietic stem cell transplantation:\n * Clinical symptoms suggesting active central nervous system (CNS) leukemia or known CNS leukemia\n * Human immunodeficiency virus (HIV) infection if not controlled by antiretroviral (ART) therapy and have CD4 count below 250 cell/mm*3\n * Chronic or active hepatitis B or C if not controlled by antiviral therapy\n * History of organ allograft (allogeneic bone marrow or stem cell transplant) within 4 months prior to first dose of study drug\n * Serious, uncontrolled infection requiring systemic antibiotic, antifungal or antiviral therapy. Prophylactic antibiotic, antifungal and/or antiviral therapy is permitted\n * Left ventricular ejection fraction (LVEF) <40%","CRP|EGFR","C-reactive protein|epidermal growth factor receptor","Protein","Breast|Ovary, Breast, Lung","Actual","2018-01-19","Actual","Anticipated","2020-09-25","Anticipated","2018-04-01","2017-11-29","2018-01-12","2018-04-04","No","Acute myeloid leukemia\nMyelodysplastic Syndromes\nChronic myelomonocytic leukemia\nDihydroorotate dehydrogenase (DHODH) inhibitor","Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"2017-002896-24","EudraCT Number","Maximum tolerated dose|Number of Adverse Events as a measure of safety and tolerability|AUC (0-24) (Area under the curve)|Cmax (Maximum concentration)","Phase 1 dose escalation study with increasing doses of study drug (BAY2402234). Maximum tolerated dose will be defined as the maximum dose administered during Cycle 1 at which the incidence of dose limiting toxicities is below 30%|Up to 6 months on average|Pre-dose, 0.5, 1, 2, 4, 6, 8, 12 hours after dose administration at Cycle 1 Day 1 and Cycle 1 Day 15","Up to 42 days after the first dose","Composite endpoint: Number of AML patients with complete remission (CR) and complete response with partial recovery of peripheral blood counts (CRh)|Change in in erythroid response as Histological Improvement criteria for patient with MDS and CMML|Change in platelet response as Histological Improvement criteria for patients with MDS and CMML|Change in neutrophil response as Histological Improvement criteria for patients with MDS and CMML","Response criteria according to modified IWG 2003. CRh is defined as <5% of blasts in the bone marrow, no evidence of disease, and partial recovery of peripheral blood counts (platelets >50,000/microliter and ANC >500/microliter)|Response criteria according to IWG 2006.","Up to 6 months on average|Every month until disease progression or patient is withdrawn from study, up to 6 months on average",{"$nulls":3},"Villejuif Cedex, France, 94805|Bronx, New York, United States, 10461 Memorial Sloan-Kettering Cancer CenterNew York, New York, United States, 10065|Philadelphia, Pennsylvania, United States, 19107|Nashville, Tennessee, United States, 37232","New York|Pennsylvania|Tennessee","France|United States","Institut Gustave Roussy - Villejuif|Albert Einstein College Of Medicine|Thomas Jefferson University|Vanderbilt University Medical Center",{"$nulls":4},"2018-04-04","2020-05-25T16:37:38.286","2020-05-26T17:10:42.972","NCT03404726"]
["5ecbf452feab101b155308fb","NCT03404726","2018-06-21","Bayer","BAYN","Recruiting","A Study to Investigate BAY2402234, a Dihydroorotate Dehydrogenase (DHODH) Inhibitor, in Myeloid Malignancies","Bay-2402234","DHODH Inhibitor","Yes","['Bay-2402234']","No",null,"Phase 1",3,120,"Anticipated","2018-04-02","2020-09-25","MTD|AUC","Maximum Tolerated Dose|Area Under The Curve",{"$nulls":3},"To determine the safety, tolerability, pharmacokinetics, maximum tolerated dose, or pharmacological active dose of BAY2402234 in patients with acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), or chronic myelomonocytic leukemia (CMML)",null,"An Open-label, Multicenter Phase 1 Study to Characterize the Safety, Tolerability, Preliminary Antileukemic Activity, Pharmacokinetics, and Maximum Tolerated Dose or Pharmacological Active Dose of BAY2402234 in Patients With Advanced Myeloid Malignancies",19420,"Leukemia","Leukemia","Oncology Hematological","Oncology","Experimental","BAY2402234/ Dose Escalation|BAY2402234/ Dose Expansion: AML|BAY2402234/ Dose Expansion: MDS","Dose escalation with sequential cohorts enrolling patients with AML, MDS, or CMML. Patients will be treated in 28-day cycles with once daily oral administration of BAY2402234|After completion of dose escalation, an expansion cohort comprised of patients with AML will start. These patients will be treated in 28 day cycles with once daily oral administration of BAY2402234 at the maximum tolerated dose or pharmacologically active dose.|After completion of dose escalation, an expansion cohort comprised of patients with MDS will start. These patients will be treated in 28 day cycles with once daily oral administration of BAY2402234 at the maximum tolerated dose or pharmacologically active dose.","Drug","BAY2402234","BAY2402234 is a potent and selective small molecule inhibitor of dihydroorotate dehydrogenase. A solution of BAY2402234 will be available to initiate the trial and there are plans to transition to a tablet form of BAY2402234 once it becomes available. Both liquid and tablet formulations of BAY2402234 will be continually administered once daily by mouth in 28 day cycles.",null,"BAY2402234/ Dose Escalation|BAY2402234/ Dose Expansion: AML|BAY2402234/ Dose Expansion: MDS","\n\n * Patients with relapsed or refractory AML. Relapsed AML is defined as relapse after achieving a response to initial therapy and refractory AML is defined as failure to achieve a response after one previous line of therapy. Response is defined as per IWG criteria (CR, CRi or CRp). Patients who are not candidates to receive or who decline standard of care therapy are also eligible.\n * Patients with intermediate-1 or higher risk MDS who have failed therapy with a hypomethylating agent, or have failed lenalidomide therapy if harboring a 5q-chromosomal deletion.\n * Patients with relapsed/refractory CMML.\n * Estimated glomerular filtration rate (eGFR) > 40 mL per 1.73 m*2\n * Patients must have adequate coagulation (international normalized ratio [INR] â‰¤ 1.5, activated partial thromboplastin time [aPTT] â‰¤1.5 X the upper limit of normal [ULN])\n * Adequate liver function (total bilirubin â‰¤1.5 X ULN (or â‰¤3 X ULN in patients with documented Gilbert's syndrome or for patients with hyperbilirubinemia considered due to myeloid disease), alanine aminotransferase [ALT] and aspartate aminotransferase [AST] â‰¤3 X ULN (or â‰¤5 X ULN for patients with liver involvement of their myeloid disease)\n\n","\n\n * Patients eligible for hematopoietic stem cell transplantation\n * Clinical symptoms suggesting active central nervous system (CNS) leukemia or known CNS leukemia\n * Human immunodeficiency virus (HIV) infection\n * Chronic or active hepatitis B or C if not controlled by antiviral therapy\n * History of organ allograft (allogeneic bone marrow or stem cell transplant) within 4 months prior to first dose of study drug\n * Serious, uncontrolled infection requiring systemic antibiotic, antifungal or antiviral therapy. Prophylactic antibiotic, antifungal and/or antiviral therapy is permitted\n * Left ventricular ejection fraction (LVEF) <40%","CRP|EGFR","C-reactive protein|epidermal growth factor receptor","Protein","Breast|Ovary, Breast, Lung","Actual","2018-01-19","Actual","Anticipated","2020-09-25","Anticipated","2018-06-01","2017-11-29","2018-01-12","2018-06-20","No","Acute myeloid leukemia\nMyelodysplastic Syndromes\nChronic myelomonocytic leukemia\nDihydroorotate dehydrogenase (DHODH) inhibitor","Interventional","Treatment","Single Group Assignment","None (Open Label)","Non-Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"2017-002896-24","EudraCT Number","Maximum tolerated dose|Number of Adverse Events as a measure of safety and tolerability|AUC (0-24) (Area under the curve)|Cmax (Maximum concentration)","Phase 1 dose escalation study with increasing doses of study drug (BAY2402234). Maximum tolerated dose will be defined as the maximum dose administered during Cycle 1 at which the incidence of dose limiting toxicities is below 30%|Up to 6 months on average|Pre-dose, 0.5, 1, 2, 4, 6, 8, 12 hours after dose administration at Cycle 1 Day 1 and Cycle 1 Day 15","Up to 42 days after the first dose","Composite endpoint: Number of AML patients with complete remission (CR) and complete response with partial recovery of peripheral blood counts (CRh)|Change in in erythroid response as Histological Improvement criteria for patient with MDS and CMML|Change in platelet response as Histological Improvement criteria for patients with MDS and CMML|Change in neutrophil response as Histological Improvement criteria for patients with MDS and CMML","Response criteria according to modified IWG 2003. CRh is defined as <5% of blasts in the bone marrow, no evidence of disease, and partial recovery of peripheral blood counts (platelets >50,000/microliter and ANC >500/microliter)|Response criteria according to IWG 2006.","Up to 6 months on average|Every month until disease progression or patient is withdrawn from study, up to 6 months on average","clinical-trials-contact@bayer.com","Bayer Clinical Trials Contact","(+) 1-888-8422937","Villejuif Cedex, France, 94805|Bronx, New York, United States, 10467-2490 Memorial Sloan-Kettering Cancer CenterNew York, New York, United States, 10065|Philadelphia, Pennsylvania, United States, 19107|Nashville, Tennessee, United States, 37232","New York|Pennsylvania|Tennessee","France|United States","Institut Gustave Roussy - Villejuif|Montefiore Medical Center|Thomas Jefferson University|Vanderbilt University Medical Center",{"$nulls":4},"2018-06-20","2020-05-25T16:37:38.858","2020-05-26T17:10:42.972","NCT03404726"]
["5ecbf452307e3d1b1f8d9d5b","NCT03404726","2018-08-14","Bayer","BAYN","Recruiting","A Study to Investigate BAY2402234, a Dihydroorotate Dehydrogenase (DHODH) Inhibitor, in Myeloid Malignancies","Bay-2402234","DHODH Inhibitor","Yes","['Bay-2402234']","No",null,"Phase 1",3,120,"Anticipated","2018-03-29","2020-08-14","MTD|AUC","Maximum Tolerated Dose|Area Under The Curve",{"$nulls":3},"To determine the safety, tolerability, pharmacokinetics, maximum tolerated dose, or pharmacological active dose of BAY2402234 in patients with acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), or chronic myelomonocytic leukemia (CMML)",null,"An Open-label, Multicenter Phase 1 Study to Characterize the Safety, Tolerability, Preliminary Antileukemic Activity, Pharmacokinetics, and Maximum Tolerated Dose or Pharmacological Active Dose of BAY2402234 in Patients With Advanced Myeloid Malignancies",19420,"Leukemia","Leukemia","Oncology Hematological","Oncology","Experimental","BAY2402234/ Dose Escalation|BAY2402234/ Dose Expansion: AML|BAY2402234/ Dose Expansion: MDS","Dose escalation with sequential cohorts enrolling patients with AML, MDS, or CMML. Patients will be treated in 28-day cycles with once daily oral administration of BAY2402234|After completion of dose escalation, an expansion cohort comprised of patients with AML will start. These patients will be treated in 28 day cycles with once daily oral administration of BAY2402234 at the maximum tolerated dose or pharmacologically active dose.|After completion of dose escalation, an expansion cohort comprised of patients with MDS will start. These patients will be treated in 28 day cycles with once daily oral administration of BAY2402234 at the maximum tolerated dose or pharmacologically active dose.","Drug","BAY2402234","BAY2402234 is a potent and selective small molecule inhibitor of dihydroorotate dehydrogenase. A solution of BAY2402234 will be available to initiate the trial and there are plans to transition to a tablet form of BAY2402234 once it becomes available. Both liquid and tablet formulations of BAY2402234 will be continually administered once daily by mouth in 28 day cycles.",null,"BAY2402234/ Dose Escalation|BAY2402234/ Dose Expansion: AML|BAY2402234/ Dose Expansion: MDS","\n\n * Patients with relapsed or refractory AML. Relapsed AML is defined as relapse after achieving a response to initial therapy and refractory AML is defined as failure to achieve a response after one previous line of therapy. Response is defined as per IWG criteria (CR, CRi or CRp). Patients who are not candidates to receive or who decline standard of care therapy are also eligible.\n * Patients with intermediate-1 or higher risk MDS who have failed therapy with a hypomethylating agent, or have failed lenalidomide therapy if harboring a 5q-chromosomal deletion.\n * Patients with relapsed/refractory CMML.\n * Estimated glomerular filtration rate (eGFR) > 40 mL per 1.73 m*2\n * Patients must have adequate coagulation (international normalized ratio [INR] â‰¤ 1.5, activated partial thromboplastin time [aPTT] â‰¤1.5 X the upper limit of normal [ULN])\n * Adequate liver function (total bilirubin â‰¤1.5 X ULN (or â‰¤3 X ULN in patients with documented Gilbert's syndrome or for patients with hyperbilirubinemia considered due to myeloid disease), alanine aminotransferase [ALT] and aspartate aminotransferase [AST] â‰¤3 X ULN (or â‰¤5 X ULN for patients with liver involvement of their myeloid disease)\n\n","\n\n * Patients eligible for hematopoietic stem cell transplantation\n * Clinical symptoms suggesting active central nervous system (CNS) leukemia or known CNS leukemia\n * Human immunodeficiency virus (HIV) infection\n * Chronic or active hepatitis B or C if not controlled by antiviral therapy\n * History of organ allograft (allogeneic bone marrow or stem cell transplant) within 4 months prior to first dose of study drug\n * Serious, uncontrolled infection requiring systemic antibiotic, antifungal or antiviral therapy. Prophylactic antibiotic, antifungal and/or antiviral therapy is permitted\n * Left ventricular ejection fraction (LVEF) <40%","CRP|EGFR","C-reactive protein|epidermal growth factor receptor","Protein","Breast|Ovary, Breast, Lung","Actual","2018-01-19","Actual","Anticipated","2020-12-14","Anticipated","2018-08-01","2017-11-29","2018-01-12","2018-08-13","No","Acute myeloid leukemia\nMyelodysplastic Syndromes\nChronic myelomonocytic leukemia\nDihydroorotate dehydrogenase (DHODH) inhibitor","Interventional","Treatment","Single Group Assignment","None (Open Label)","Non-Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"2017-002896-24","EudraCT Number","Maximum tolerated dose|Number of Adverse Events as a measure of safety and tolerability|AUC (0-24) (Area under the curve)|Cmax (Maximum concentration)","Phase 1 dose escalation study with increasing doses of study drug (BAY2402234). Maximum tolerated dose will be defined as the maximum dose administered during Cycle 1 at which the incidence of dose limiting toxicities is below 30%|Up to 6 months on average|Pre-dose, 0.5, 1, 2, 4, 6, 8, 12 hours after dose administration at Cycle 1 Day 1 and Cycle 1 Day 15","Up to 42 days after the first dose","Composite endpoint: Number of AML patients with complete remission (CR) and complete response with partial recovery of peripheral blood counts (CRh)|Change in in erythroid response as Histological Improvement criteria for patient with MDS and CMML|Change in platelet response as Histological Improvement criteria for patients with MDS and CMML|Change in neutrophil response as Histological Improvement criteria for patients with MDS and CMML","Response criteria according to modified IWG 2003. CRh is defined as <5% of blasts in the bone marrow, no evidence of disease, and partial recovery of peripheral blood counts (platelets >50,000/microliter and ANC >500/microliter)|Response criteria according to IWG 2006.","Up to 6 months on average|Every month until disease progression or patient is withdrawn from study, up to 6 months on average","clinical-trials-contact@bayer.com","Bayer Clinical Trials Contact","(+) 1-888-8422937","Villejuif Cedex, France, 94805|Bronx, New York, United States, 10467-2490 Memorial Sloan-Kettering Cancer CenterNew York, New York, United States, 10065|Philadelphia, Pennsylvania, United States, 19107|Nashville, Tennessee, United States, 37232","New York|Pennsylvania|Tennessee","France|United States","Institut Gustave Roussy - Villejuif|Montefiore Medical Center|Thomas Jefferson University|Vanderbilt University Medical Center",{"$nulls":4},"2018-08-13","2020-05-25T16:37:38.696","2020-05-26T17:10:42.972","NCT03404726"]
["5ecbf45211702c1b1b916ada","NCT03404726","2018-08-31","Bayer","BAYN","Recruiting","A Study to Investigate BAY2402234, a Dihydroorotate Dehydrogenase (DHODH) Inhibitor, in Myeloid Malignancies","Bay-2402234","DHODH Inhibitor","Yes","['Bay-2402234']","No",null,"Phase 1",3,120,"Anticipated","2018-03-29","2020-08-14","MTD|AUC","Maximum Tolerated Dose|Area Under The Curve",{"$nulls":3},"To determine the safety, tolerability, pharmacokinetics, maximum tolerated dose, or pharmacological active dose of BAY2402234 in patients with acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), or chronic myelomonocytic leukemia (CMML)",null,"An Open-label, Multicenter Phase 1 Study to Characterize the Safety, Tolerability, Preliminary Antileukemic Activity, Pharmacokinetics, and Maximum Tolerated Dose or Pharmacological Active Dose of BAY2402234 in Patients With Advanced Myeloid Malignancies",19420,"Leukemia","Leukemia","Oncology Hematological","Oncology","Experimental","BAY2402234/ Dose Escalation|BAY2402234/ Dose Expansion: AML|BAY2402234/ Dose Expansion: MDS","Dose escalation with sequential cohorts enrolling patients with AML, MDS, or CMML. Patients will be treated in 28-day cycles with once daily oral administration of BAY2402234|After completion of dose escalation, an expansion cohort comprised of patients with AML will start. These patients will be treated in 28 day cycles with once daily oral administration of BAY2402234 at the maximum tolerated dose or pharmacologically active dose.|After completion of dose escalation, an expansion cohort comprised of patients with MDS will start. These patients will be treated in 28 day cycles with once daily oral administration of BAY2402234 at the maximum tolerated dose or pharmacologically active dose.","Drug","BAY2402234","BAY2402234 is a potent and selective small molecule inhibitor of dihydroorotate dehydrogenase. A solution of BAY2402234 will be available to initiate the trial and there are plans to transition to a tablet form of BAY2402234 once it becomes available. Both liquid and tablet formulations of BAY2402234 will be continually administered once daily by mouth in 28 day cycles.",null,"BAY2402234/ Dose Escalation|BAY2402234/ Dose Expansion: AML|BAY2402234/ Dose Expansion: MDS","\n\n * Patients with relapsed or refractory AML. Relapsed AML is defined as relapse after achieving a response to initial therapy and refractory AML is defined as failure to achieve a response after one previous line of therapy. Response is defined as per IWG criteria (CR, CRi or CRp). Patients who are not candidates to receive or who decline standard of care therapy are also eligible.\n * Patients with intermediate-1 or higher risk MDS who have failed therapy with a hypomethylating agent, or have failed lenalidomide therapy if harboring a 5q-chromosomal deletion.\n * Patients with relapsed/refractory CMML.\n * Estimated glomerular filtration rate (eGFR) > 40 mL per 1.73 m*2\n * Patients must have adequate coagulation (international normalized ratio [INR] â‰¤ 1.5, activated partial thromboplastin time [aPTT] â‰¤1.5 X the upper limit of normal [ULN])\n * Adequate liver function (total bilirubin â‰¤1.5 X ULN (or â‰¤3 X ULN in patients with documented Gilbert's syndrome or for patients with hyperbilirubinemia considered due to myeloid disease), alanine aminotransferase [ALT] and aspartate aminotransferase [AST] â‰¤3 X ULN (or â‰¤5 X ULN for patients with liver involvement of their myeloid disease)\n\n","\n\n * Patients eligible for hematopoietic stem cell transplantation\n * Clinical symptoms suggesting active central nervous system (CNS) leukemia or known CNS leukemia\n * Human immunodeficiency virus (HIV) infection\n * Chronic or active hepatitis B or C if not controlled by antiviral therapy\n * History of organ allograft (allogeneic bone marrow or stem cell transplant) within 4 months prior to first dose of study drug\n * Serious, uncontrolled infection requiring systemic antibiotic, antifungal or antiviral therapy. Prophylactic antibiotic, antifungal and/or antiviral therapy is permitted\n * Left ventricular ejection fraction (LVEF) <40%","CRP|EGFR","C-reactive protein|epidermal growth factor receptor","Protein","Breast|Ovary, Breast, Lung","Actual","2018-01-19","Actual","Anticipated","2020-12-14","Anticipated","2018-08-01","2017-11-29","2018-01-12","2018-08-30","No","Acute myeloid leukemia\nMyelodysplastic Syndromes\nChronic myelomonocytic leukemia\nDihydroorotate dehydrogenase (DHODH) inhibitor","Interventional","Treatment","Single Group Assignment","None (Open Label)","Non-Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"2017-002896-24","EudraCT Number","Maximum tolerated dose|Number of Adverse Events as a measure of safety and tolerability|AUC (0-24) (Area under the curve)|Cmax (Maximum concentration)","Phase 1 dose escalation study with increasing doses of study drug (BAY2402234). Maximum tolerated dose will be defined as the maximum dose administered during Cycle 1 at which the incidence of dose limiting toxicities is below 30%|Up to 6 months on average|Pre-dose, 0.5, 1, 2, 4, 6, 8, 12 hours after dose administration at Cycle 1 Day 1 and Cycle 1 Day 15","Up to 42 days after the first dose","Composite endpoint: Number of AML patients with complete remission (CR) and complete response with partial recovery of peripheral blood counts (CRh)|Change in in erythroid response as Histological Improvement criteria for patient with MDS and CMML|Change in platelet response as Histological Improvement criteria for patients with MDS and CMML|Change in neutrophil response as Histological Improvement criteria for patients with MDS and CMML","Response criteria according to modified IWG 2003. CRh is defined as <5% of blasts in the bone marrow, no evidence of disease, and partial recovery of peripheral blood counts (platelets >50,000/microliter and ANC >500/microliter)|Response criteria according to IWG 2006.","Up to 6 months on average|Every month until disease progression or patient is withdrawn from study, up to 6 months on average","clinical-trials-contact@bayer.com","Bayer Clinical Trials Contact","(+) 1-888-8422937","Villejuif Cedex, France, 94805|Bronx, New York, United States, 10467-2490 Memorial Sloan-Kettering Cancer CenterNew York, New York, United States, 10065|Philadelphia, Pennsylvania, United States, 19107|Nashville, Tennessee, United States, 37232","New York|Pennsylvania|Tennessee","France|United States","Institut Gustave Roussy|Montefiore Medical Center|Thomas Jefferson University|Vanderbilt University Medical Center",{"$nulls":4},"2018-08-30","2020-05-25T16:37:38.584","2020-05-26T17:10:42.972","NCT03404726"]
["5ecbf453307e3d1b1f8d9d5d","NCT03404726","2018-12-17","Bayer","BAYN","Recruiting","A Study to Investigate BAY2402234, a Dihydroorotate Dehydrogenase (DHODH) Inhibitor, in Myeloid Malignancies","Bay-2402234","DHODH Inhibitor","Yes","['Bay-2402234']","No",null,"Phase 1",3,120,"Anticipated","2018-03-29","2020-08-14","MTD|AUC","Maximum Tolerated Dose|Area Under The Curve",{"$nulls":3},"The primary objective is to determine the safety, tolerability, pharmacokinetics, maximum tolerated dose (MTD), or pharmacological active dose (PAD) of BAY2402234 in patients with acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), or chronic myelomonocytic leukemia (CMML).\n\nThe secondary objective is to evaluate evidence of clinical efficacy associated with BAY2402234 in patients with AML (defined as Complete remission, Complete remission with partial hematologic recovery), and MDS (defined as hematological improvement).",null,"An Open-label, Multicenter Phase 1 Study to Characterize the Safety, Tolerability, Preliminary Antileukemic Activity, Pharmacokinetics, and Maximum Tolerated Dose or Pharmacological Active Dose of BAY2402234 in Patients With Advanced Myeloid Malignancies",19420,"Leukemia","Leukemia","Oncology Hematological","Oncology","Experimental","Dose Escalation|Dose Expansion: AML|Dose Expansion: MDS","Dose escalation with sequential cohorts enrolling patients with AML, MDS, or CMML. Patients will be treated in 28-day cycles with once daily oral administration of BAY2402234|After completion of dose escalation, an expansion cohort comprised of patients with AML will start. These patients will be treated in 28 day cycles with once daily oral administration of BAY2402234 at the maximum tolerated dose or pharmacologically active dose.|After completion of dose escalation, an expansion cohort comprised of patients with MDS will start. These patients will be treated in 28 day cycles with once daily oral administration of BAY2402234 at the maximum tolerated dose or pharmacologically active dose.","Drug","BAY2402234","BAY2402234 is a potent and selective small molecule inhibitor of dihydroorotate dehydrogenase. A solution of BAY2402234 will be available to initiate the trial and there are plans to transition to a tablet form of BAY2402234 once it becomes available. Both liquid and tablet formulations of BAY2402234 will be continually administered once daily by mouth in 28 day cycles.",null,"Dose Escalation|Dose Expansion: AML|Dose Expansion: MDS","\n\n * Patients with relapsed or refractory AML. Relapsed AML is defined as relapse after achieving a response to initial therapy and refractory AML is defined as failure to achieve a response after one previous line of therapy. Response is defined as per IWG criteria (CR, CRi or CRp). Patients who are not candidates to receive or who decline standard of care therapy are also eligible.\n * Patients with intermediate-1 or higher risk MDS who have failed therapy with a hypomethylating agent, or have failed lenalidomide therapy if harboring a 5q-chromosomal deletion.\n * Patients with relapsed/refractory CMML.\n * Estimated glomerular filtration rate (eGFR) > 40 mL per 1.73 m*2\n * Patients must have adequate coagulation (international normalized ratio [INR] â‰¤ 1.5; activated partial thromboplastin time [aPTT] â‰¤1.5 X the upper limit of normal [ULN]; patients on chronic anticoagulation therapy at investigator's discretion; patients on chronic use of direct-acting oral anticoagulants who have acceptable benefit-risk ratio at investigator's discretion)\n * Adequate liver function (total bilirubin â‰¤1.5 X ULN (or â‰¤3 X ULN in patients with documented Gilbert's syndrome or for patients with hyperbilirubinemia considered due to myeloid disease), alanine aminotransferase [ALT] and aspartate aminotransferase [AST] â‰¤3 X ULN (or â‰¤5 X ULN for patients with liver involvement of their myeloid disease)\n\n","\n\n * Patients eligible for hematopoietic stem cell transplantation\n * Clinical symptoms suggesting active central nervous system (CNS) leukemia or known CNS leukemia\n * Human immunodeficiency virus (HIV) infection\n * Chronic or active hepatitis B or C if not controlled by antiviral therapy\n * History of organ allograft (allogeneic bone marrow or stem cell transplant) within 3 months prior to first dose of study drug\n * Serious, uncontrolled infection requiring systemic antibiotic, antifungal or antiviral therapy. Prophylactic antibiotic, antifungal and/or antiviral therapy is permitted\n * Left ventricular ejection fraction (LVEF) <40%","CRP|EGFR","C-reactive protein|epidermal growth factor receptor","Protein","Breast|Ovary, Breast, Lung","Actual","2018-01-19","Actual","Anticipated","2020-12-14","Anticipated","2018-12-01","2017-11-29","2018-01-12","2018-12-13","No","Acute myeloid leukemia\nMyelodysplastic Syndromes\nChronic myelomonocytic leukemia\nDihydroorotate dehydrogenase (DHODH) inhibitor","Interventional","Treatment","Single Group Assignment","None (Open Label)","Non-Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"2017-002896-24","EudraCT Number","Maximum tolerated dose|Number of Adverse Events as a measure of safety and tolerability|AUC (0-24) (Area under the curve)|Cmax (Maximum concentration)","Phase 1 dose escalation study with increasing doses of study drug (BAY2402234). Maximum tolerated dose will be defined as the maximum dose administered during Cycle 1 at which the incidence of dose limiting toxicities is closest to 30%.|Up to 6 months on average|Pre-dose, 0.5, 1, 2, 4, 6, 8, 12 hours after dose administration at Cycle 1 Day 1 and Cycle 1 Day 15","Up to 42 days after the first dose","Composite endpoint: Number of AML patients with complete remission (CR) and complete response with partial recovery of peripheral blood counts (CRh)|Change in erythroid response as Histological Improvement criteria for patients with MDS and CMML|Change in platelet response as Histological Improvement criteria for patients with MDS and CMML|Change in neutrophil response as Histological Improvement criteria for patients with MDS and CMML","Response criteria according to modified IWG 2003. CRh is defined as <5% of blasts in the bone marrow, no evidence of disease, and partial recovery of peripheral blood counts (platelets >50,000/microliter and ANC >500/microliter)|Response criteria according to IWG 2006.","Up to 6 months on average|Every month until disease progression or patient is withdrawn from study, up to 6 months on average","clinical-trials-contact@bayer.com","Bayer Clinical Trials Contact","(+) 1-888-8422937","Villejuif Cedex, France, 94805|Bronx, New York, United States, 10467-2490 Memorial Sloan-Kettering Cancer CenterNew York, New York, United States, 10065|Philadelphia, Pennsylvania, United States, 19107|Nashville, Tennessee, United States, 37232","New York|Pennsylvania|Tennessee","France|United States","Institut Gustave Roussy|Montefiore Medical Center|Thomas Jefferson University|Vanderbilt University Medical Center",{"$nulls":4},"2018-12-13","2020-05-25T16:37:39.418","2020-05-26T17:10:42.972","NCT03404726"]
["5ecbf453fe30261b1a0482cc","NCT03404726","2019-01-09","Bayer","BAYN","Recruiting","A Study to Investigate BAY2402234, a Dihydroorotate Dehydrogenase (DHODH) Inhibitor, in Myeloid Malignancies","Bay-2402234","DHODH Inhibitor","Yes","['Bay-2402234']","No",null,"Phase 1",3,120,"Anticipated","2018-03-29","2020-08-14","MTD|AUC","Maximum Tolerated Dose|Area Under The Curve",{"$nulls":3},"The primary objective is to determine the safety, tolerability, pharmacokinetics, maximum tolerated dose (MTD), or pharmacological active dose (PAD) of BAY2402234 in patients with acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), or chronic myelomonocytic leukemia (CMML).\n\nThe secondary objective is to evaluate evidence of clinical efficacy associated with BAY2402234 in patients with AML (defined as Complete remission, Complete remission with partial hematologic recovery), and MDS (defined as hematological improvement).",null,"An Open-label, Multicenter Phase 1 Study to Characterize the Safety, Tolerability, Preliminary Antileukemic Activity, Pharmacokinetics, and Maximum Tolerated Dose or Pharmacological Active Dose of BAY2402234 in Patients With Advanced Myeloid Malignancies",19420,"Leukemia","Leukemia","Oncology Hematological","Oncology","Experimental","Dose Escalation|Dose Expansion: AML|Dose Expansion: MDS","Dose escalation with sequential cohorts enrolling patients with AML, MDS, or CMML. Patients will be treated in 28-day cycles with once daily oral administration of BAY2402234|After completion of dose escalation, an expansion cohort comprised of patients with AML will start. These patients will be treated in 28 day cycles with once daily oral administration of BAY2402234 at the maximum tolerated dose or pharmacologically active dose.|After completion of dose escalation, an expansion cohort comprised of patients with MDS will start. These patients will be treated in 28 day cycles with once daily oral administration of BAY2402234 at the maximum tolerated dose or pharmacologically active dose.","Drug","BAY2402234","BAY2402234 is a potent and selective small molecule inhibitor of dihydroorotate dehydrogenase. A solution of BAY2402234 will be available to initiate the trial and there are plans to transition to a tablet form of BAY2402234 once it becomes available. Both liquid and tablet formulations of BAY2402234 will be continually administered once daily by mouth in 28 day cycles.",null,"Dose Escalation|Dose Expansion: AML|Dose Expansion: MDS","\n\n * Patients with relapsed or refractory AML. Relapsed AML is defined as relapse after achieving a response to initial therapy and refractory AML is defined as failure to achieve a response after one previous line of therapy. Response is defined as per IWG criteria (CR, CRi or CRp). Patients who are not candidates to receive or who decline standard of care therapy are also eligible.\n * Patients with intermediate-1 or higher risk MDS who have failed therapy with a hypomethylating agent, or have failed lenalidomide therapy if harboring a 5q-chromosomal deletion.\n * Patients with relapsed/refractory CMML.\n * Estimated glomerular filtration rate (eGFR) > 40 mL per 1.73 m*2\n * Patients must have adequate coagulation (international normalized ratio [INR] â‰¤ 1.5; activated partial thromboplastin time [aPTT] â‰¤1.5 X the upper limit of normal [ULN]; patients on chronic anticoagulation therapy at investigator's discretion; patients on chronic use of direct-acting oral anticoagulants who have acceptable benefit-risk ratio at investigator's discretion)\n * Adequate liver function (total bilirubin â‰¤1.5 X ULN (or â‰¤3 X ULN in patients with documented Gilbert's syndrome or for patients with hyperbilirubinemia considered due to myeloid disease), alanine aminotransferase [ALT] and aspartate aminotransferase [AST] â‰¤3 X ULN (or â‰¤5 X ULN for patients with liver involvement of their myeloid disease)\n\n","\n\n * Patients eligible for hematopoietic stem cell transplantation\n * Clinical symptoms suggesting active central nervous system (CNS) leukemia or known CNS leukemia\n * Human immunodeficiency virus (HIV) infection\n * Chronic or active hepatitis B or C if not controlled by antiviral therapy\n * History of organ allograft (allogeneic bone marrow or stem cell transplant) within 3 months prior to first dose of study drug\n * Serious, uncontrolled infection requiring systemic antibiotic, antifungal or antiviral therapy. Prophylactic antibiotic, antifungal and/or antiviral therapy is permitted\n * Left ventricular ejection fraction (LVEF) <40%","CRP|EGFR","C-reactive protein|epidermal growth factor receptor","Protein","Breast|Ovary, Breast, Lung","Actual","2018-01-19","Actual","Anticipated","2020-12-14","Anticipated","2019-01-01","2017-11-29","2018-01-12","2019-01-08","No","Acute myeloid leukemia\nMyelodysplastic Syndromes\nChronic myelomonocytic leukemia\nDihydroorotate dehydrogenase (DHODH) inhibitor","Interventional","Treatment","Single Group Assignment","None (Open Label)","Non-Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"2017-002896-24","EudraCT Number","Maximum tolerated dose|Number of Adverse Events as a measure of safety and tolerability|AUC (0-24) (Area under the curve)|Cmax (Maximum concentration)","Phase 1 dose escalation study with increasing doses of study drug (BAY2402234). Maximum tolerated dose will be defined as the maximum dose administered during Cycle 1 at which the incidence of dose limiting toxicities is closest to 30%.|Up to 6 months on average|Pre-dose, 0.5, 1, 2, 4, 6, 8, 12 hours after dose administration at Cycle 1 Day 1 and Cycle 1 Day 15","Up to 42 days after the first dose","Composite endpoint: Number of AML patients with complete remission (CR) and complete response with partial recovery of peripheral blood counts (CRh)|Change in erythroid response as Histological Improvement criteria for patients with MDS and CMML|Change in platelet response as Histological Improvement criteria for patients with MDS and CMML|Change in neutrophil response as Histological Improvement criteria for patients with MDS and CMML","Response criteria according to modified IWG 2003. CRh is defined as <5% of blasts in the bone marrow, no evidence of disease, and partial recovery of peripheral blood counts (platelets >50,000/microliter and ANC >500/microliter)|Response criteria according to IWG 2006.","Up to 6 months on average|Every month until disease progression or patient is withdrawn from study, up to 6 months on average","clinical-trials-contact@bayer.com","Bayer Clinical Trials Contact","(+) 1-888-8422937","Villejuif Cedex, France, 94805|Bronx, New York, United States, 10467-2490 Memorial Sloan-Kettering Cancer CenterNew York, New York, United States, 10065|Philadelphia, Pennsylvania, United States, 19107|Nashville, Tennessee, United States, 37232","New York|Pennsylvania|Tennessee","France|United States","Institut Gustave Roussy|Montefiore Medical Center|Thomas Jefferson University|Vanderbilt University Medical Center",{"$nulls":4},"2019-01-08","2020-05-25T16:37:39.341","2020-05-26T17:10:42.972","NCT03404726"]
["5ecbf45311702c1b1b916adc","NCT03404726","2019-05-01","Bayer","BAYN","Recruiting","A Study to Investigate BAY2402234, a Dihydroorotate Dehydrogenase (DHODH) Inhibitor, in Myeloid Malignancies","Bay-2402234","DHODH Inhibitor","Yes","['Bay-2402234']","No",null,"Phase 1",3,120,"Anticipated","2018-03-29","2021-01-12","MTD|AUC","Maximum Tolerated Dose|Area Under The Curve",{"$nulls":3},"The primary objective is to determine the safety, tolerability, pharmacokinetics, maximum tolerated dose (MTD), or pharmacological active dose (PAD) of BAY2402234 in patients with acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), or chronic myelomonocytic leukemia (CMML).\n\nThe secondary objective is to evaluate evidence of clinical efficacy associated with BAY2402234 in patients with AML (defined as Complete remission, Complete remission with partial hematologic recovery), and MDS (defined as hematological improvement).",null,"An Open-label, Multicenter Phase 1 Study to Characterize the Safety, Tolerability, Preliminary Antileukemic Activity, Pharmacokinetics, and Maximum Tolerated Dose or Pharmacological Active Dose of BAY2402234 in Patients With Advanced Myeloid Malignancies",19420,"Leukemia","Leukemia","Oncology Hematological","Oncology","Experimental","Dose Escalation|Dose Expansion: AML|Dose Expansion: MDS","Dose escalation with sequential cohorts enrolling patients with AML, MDS, or CMML. Patients will be treated in 28-day cycles with once daily oral administration of BAY2402234|After completion of dose escalation, an expansion cohort comprised of patients with AML will start. These patients will be treated in 28 day cycles with once daily oral administration of BAY2402234 at the maximum tolerated dose or pharmacologically active dose.|After completion of dose escalation, an expansion cohort comprised of patients with MDS will start. These patients will be treated in 28 day cycles with once daily oral administration of BAY2402234 at the maximum tolerated dose or pharmacologically active dose.","Drug","BAY2402234","BAY2402234 is a potent and selective small molecule inhibitor of dihydroorotate dehydrogenase. A solution of BAY2402234 will be available to initiate the trial and there are plans to transition to a tablet form of BAY2402234 once it becomes available. Both liquid and tablet formulations of BAY2402234 will be continually administered once daily by mouth in 28 day cycles.",null,"Dose Escalation|Dose Expansion: AML|Dose Expansion: MDS","\n\n * Patients with relapsed or refractory AML. Relapsed AML is defined as relapse after achieving a response to initial therapy and refractory AML is defined as failure to achieve a response after one previous line of therapy. Response is defined as per IWG criteria (CR, CRi or CRp). Patients who are not candidates to receive or who decline standard of care therapy are also eligible.\n * Patients with intermediate-1 or higher risk MDS who have failed therapy with a hypomethylating agent, or have failed lenalidomide therapy if harboring a 5q-chromosomal deletion.\n * Patients with relapsed/refractory CMML.\n * Estimated glomerular filtration rate (eGFR) > 40 mL per 1.73 m*2\n * Patients must have adequate coagulation (international normalized ratio [INR] â‰¤ 1.5; activated partial thromboplastin time [aPTT] â‰¤1.5 X the upper limit of normal [ULN]; patients on chronic anticoagulation therapy at investigator's discretion; patients on chronic use of direct-acting oral anticoagulants who have acceptable benefit-risk ratio at investigator's discretion)\n * Adequate liver function (total bilirubin â‰¤1.5 X ULN (or â‰¤3 X ULN in patients with documented Gilbert's syndrome or for patients with hyperbilirubinemia considered due to myeloid disease), alanine aminotransferase [ALT] and aspartate aminotransferase [AST] â‰¤3 X ULN (or â‰¤5 X ULN for patients with liver involvement of their myeloid disease)\n\n","\n\n * Patients eligible for hematopoietic stem cell transplantation\n * Clinical symptoms suggesting active central nervous system (CNS) leukemia or known CNS leukemia\n * Human immunodeficiency virus (HIV) infection\n * Chronic or active hepatitis B or C if not controlled by antiviral therapy\n * History of organ allograft (allogeneic bone marrow or stem cell transplant) within 3 months prior to first dose of study drug\n * Serious, uncontrolled infection requiring systemic antibiotic, antifungal or antiviral therapy. Prophylactic antibiotic, antifungal and/or antiviral therapy is permitted\n * Left ventricular ejection fraction (LVEF) <40%","CRP|EGFR","C-reactive protein|epidermal growth factor receptor","Protein","Breast|Ovary, Breast, Lung","Actual","2018-01-19","Actual","Anticipated","2021-06-03","Anticipated","2019-04-01","2017-11-29","2018-01-12","2019-04-30","No","Acute myeloid leukemia\nMyelodysplastic Syndromes\nChronic myelomonocytic leukemia\nDihydroorotate dehydrogenase (DHODH) inhibitor","Interventional","Treatment","Single Group Assignment","None (Open Label)","Non-Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"2017-002896-24","EudraCT Number","Maximum tolerated dose|Number of Adverse Events as a measure of safety and tolerability|AUC (0-24) (Area under the curve)|Cmax (Maximum concentration)","Phase 1 dose escalation study with increasing doses of study drug (BAY2402234). Maximum tolerated dose will be defined as the maximum dose administered during Cycle 1 at which the incidence of dose limiting toxicities is closest to 30%.|Up to 6 months on average|Pre-dose, 0.5, 1, 2, 4, 6, 8, 12 hours after dose administration at Cycle 1 Day 1 and Cycle 1 Day 15","Up to 42 days after the first dose","Composite endpoint: Number of AML patients with complete remission (CR) and complete response with partial recovery of peripheral blood counts (CRh)|Change in erythroid response as Histological Improvement criteria for patients with MDS and CMML|Change in platelet response as Histological Improvement criteria for patients with MDS and CMML|Change in neutrophil response as Histological Improvement criteria for patients with MDS and CMML","Response criteria according to modified IWG 2003. CRh is defined as <5% of blasts in the bone marrow, no evidence of disease, and partial recovery of peripheral blood counts (platelets >50,000/microliter and ANC >500/microliter)|Response criteria according to IWG 2006.","Up to 6 months on average|Every month until disease progression or patient is withdrawn from study, up to 6 months on average","clinical-trials-contact@bayer.com","Bayer Clinical Trials Contact","(+) 1-888-8422937","Villejuif Cedex, France, 94805|Bronx, New York, United States, 10467-2490 Memorial Sloan-Kettering Cancer CenterNew York, New York, United States, 10065|Philadelphia, Pennsylvania, United States, 19107|Nashville, Tennessee, United States, 37232","New York|Pennsylvania|Tennessee","France|United States","Institut Gustave Roussy|Montefiore Medical Center|Thomas Jefferson University|Vanderbilt University Medical Center",{"$nulls":4},"2019-04-30","2020-05-25T16:37:39.448","2020-05-26T17:10:42.972","NCT03404726"]
["5ecbf453e2561b1b11905dc9","NCT03404726","2019-05-22","Bayer","BAYN","Recruiting","A Study to Investigate BAY2402234, a Dihydroorotate Dehydrogenase (DHODH) Inhibitor, in Myeloid Malignancies","Bay-2402234","DHODH Inhibitor","Yes","['Bay-2402234']","No",null,"Phase 1",3,120,"Anticipated","2018-03-29","2021-01-12","MTD|AUC","Maximum Tolerated Dose|Area Under The Curve",{"$nulls":3},"The primary objective is to determine the safety, tolerability, pharmacokinetics, maximum tolerated dose (MTD), or pharmacological active dose (PAD) of BAY2402234 in patients with acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), or chronic myelomonocytic leukemia (CMML).\n\nThe secondary objective is to evaluate evidence of clinical efficacy associated with BAY2402234 in patients with AML (defined as Complete remission, Complete remission with partial hematologic recovery), and MDS (defined as hematological improvement).",null,"An Open-label, Multicenter Phase 1 Study to Characterize the Safety, Tolerability, Preliminary Antileukemic Activity, Pharmacokinetics, and Maximum Tolerated Dose or Pharmacological Active Dose of BAY2402234 in Patients With Advanced Myeloid Malignancies",19420,"Leukemia","Leukemia","Oncology Hematological","Oncology","Experimental","Dose Escalation|Dose Expansion: AML|Dose Expansion: MDS","Dose escalation with sequential cohorts enrolling patients with AML, MDS, or CMML. Patients will be treated in 28-day cycles with once daily oral administration of BAY2402234|After completion of dose escalation, an expansion cohort comprised of patients with AML will start. These patients will be treated in 28 day cycles with once daily oral administration of BAY2402234 at the maximum tolerated dose or pharmacologically active dose.|After completion of dose escalation, an expansion cohort comprised of patients with MDS will start. These patients will be treated in 28 day cycles with once daily oral administration of BAY2402234 at the maximum tolerated dose or pharmacologically active dose.","Drug","BAY2402234","BAY2402234 is a potent and selective small molecule inhibitor of dihydroorotate dehydrogenase. A solution of BAY2402234 will be available to initiate the trial and there are plans to transition to a tablet form of BAY2402234 once it becomes available. Both liquid and tablet formulations of BAY2402234 will be continually administered once daily by mouth in 28 day cycles.",null,"Dose Escalation|Dose Expansion: AML|Dose Expansion: MDS","\n\n * Patients with relapsed or refractory AML. Relapsed AML is defined as relapse after achieving a response to initial therapy and refractory AML is defined as failure to achieve a response after one previous line of therapy. Response is defined as per IWG criteria (CR, CRi or CRp). Patients who are not candidates to receive or who decline standard of care therapy are also eligible.\n * Patients with intermediate-1 or higher risk MDS who have failed therapy with a hypomethylating agent, or have failed lenalidomide therapy if harboring a 5q-chromosomal deletion.\n * Patients with relapsed/refractory CMML.\n * Estimated glomerular filtration rate (eGFR) > 40 mL per 1.73 m*2\n * Patients must have adequate coagulation (international normalized ratio [INR] â‰¤ 1.5; activated partial thromboplastin time [aPTT] â‰¤1.5 X the upper limit of normal [ULN]; patients on chronic anticoagulation therapy at investigator's discretion; patients on chronic use of direct-acting oral anticoagulants who have acceptable benefit-risk ratio at investigator's discretion)\n * Adequate liver function (total bilirubin â‰¤1.5 X ULN (or â‰¤3 X ULN in patients with documented Gilbert's syndrome or for patients with hyperbilirubinemia considered due to myeloid disease), alanine aminotransferase [ALT] and aspartate aminotransferase [AST] â‰¤3 X ULN (or â‰¤5 X ULN for patients with liver involvement of their myeloid disease)\n\n","\n\n * Patients eligible for hematopoietic stem cell transplantation\n * Clinical symptoms suggesting active central nervous system (CNS) leukemia or known CNS leukemia\n * Human immunodeficiency virus (HIV) infection\n * Chronic or active hepatitis B or C if not controlled by antiviral therapy\n * History of organ allograft (allogeneic bone marrow or stem cell transplant) within 3 months prior to first dose of study drug\n * Serious, uncontrolled infection requiring systemic antibiotic, antifungal or antiviral therapy. Prophylactic antibiotic, antifungal and/or antiviral therapy is permitted\n * Left ventricular ejection fraction (LVEF) <40%","CRP|EGFR","C-reactive protein|epidermal growth factor receptor","Protein","Breast|Ovary, Breast, Lung","Actual","2018-01-19","Actual","Anticipated","2021-06-03","Anticipated","2019-05-01","2017-11-29","2018-01-12","2019-05-21","No","Acute myeloid leukemia\nMyelodysplastic Syndromes\nChronic myelomonocytic leukemia\nDihydroorotate dehydrogenase (DHODH) inhibitor","Interventional","Treatment","Single Group Assignment","None (Open Label)","Non-Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"2017-002896-24","EudraCT Number","Maximum tolerated dose|Number of Adverse Events as a measure of safety and tolerability|AUC (0-24) (Area under the curve)|Cmax (Maximum concentration)","Phase 1 dose escalation study with increasing doses of study drug (BAY2402234). Maximum tolerated dose will be defined as the maximum dose administered during Cycle 1 at which the incidence of dose limiting toxicities is closest to 30%.|Up to 6 months on average|Pre-dose, 0.5, 1, 2, 4, 6, 8, 12 hours after dose administration at Cycle 1 Day 1 and Cycle 1 Day 15","Up to 42 days after the first dose","Composite endpoint: Number of AML patients with complete remission (CR) and complete response with partial recovery of peripheral blood counts (CRh)|Change in erythroid response as Histological Improvement criteria for patients with MDS and CMML|Change in platelet response as Histological Improvement criteria for patients with MDS and CMML|Change in neutrophil response as Histological Improvement criteria for patients with MDS and CMML","Response criteria according to modified IWG 2003. CRh is defined as <5% of blasts in the bone marrow, no evidence of disease, and partial recovery of peripheral blood counts (platelets >50,000/microliter and ANC >500/microliter)|Response criteria according to IWG 2006.","Up to 6 months on average|Every month until disease progression or patient is withdrawn from study, up to 6 months on average","clinical-trials-contact@bayer.com","Bayer Clinical Trials Contact","(+) 1-888-8422937","Villejuif Cedex, France, 94805|Bronx, New York, United States, 10467-2490 Memorial Sloan-Kettering Cancer CenterNew York, New York, United States, 10065|Philadelphia, Pennsylvania, United States, 19107|Nashville, Tennessee, United States, 37232","New York|Pennsylvania|Tennessee","France|United States","Institut Gustave Roussy|Montefiore Medical Center|Thomas Jefferson University|Vanderbilt University Medical Center",{"$nulls":4},"2019-05-21","2020-05-25T16:37:39.922","2020-05-26T17:10:42.972","NCT03404726"]
["5ecbf453307e3d1b1f8d9d5e","NCT03404726","2019-10-25","Bayer","BAYN","Recruiting","A Study to Investigate BAY2402234, a Dihydroorotate Dehydrogenase (DHODH) Inhibitor, in Myeloid Malignancies","Bay-2402234","DHODH Inhibitor","Yes","['Bay-2402234']","No",null,"Phase 1",3,120,"Anticipated","2018-03-29","2021-04-12","MTD|AUC","Maximum Tolerated Dose|Area Under The Curve",{"$nulls":3},"The primary objective is to determine the safety, tolerability, pharmacokinetics, maximum tolerated dose (MTD), or pharmacological active dose (PAD) of BAY2402234 in patients with acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), or chronic myelomonocytic leukemia (CMML).\n\nThe secondary objective is to evaluate evidence of clinical efficacy associated with BAY2402234 in patients with AML (defined as Complete remission, Complete remission with partial hematologic recovery), and MDS (defined as hematological improvement).",null,"An Open-label, Multicenter Phase 1 Study to Characterize the Safety, Tolerability, Preliminary Antileukemic Activity, Pharmacokinetics, and Maximum Tolerated Dose or Pharmacological Active Dose of BAY2402234 in Patients With Advanced Myeloid Malignancies",19420,"Leukemia","Leukemia","Oncology Hematological","Oncology","Experimental","Dose Escalation|Dose Expansion: AML|Dose Expansion: MDS","Dose escalation with sequential cohorts enrolling patients with AML, MDS, or CMML. Patients will be treated in 28-day cycles with once daily oral administration of BAY2402234|After completion of dose escalation, an expansion cohort comprised of patients with AML will start. These patients will be treated in 28 day cycles with once daily oral administration of BAY2402234 at the maximum tolerated dose or pharmacologically active dose.|After completion of dose escalation, an expansion cohort comprised of patients with MDS will start. These patients will be treated in 28 day cycles with once daily oral administration of BAY2402234 at the maximum tolerated dose or pharmacologically active dose.","Drug","BAY2402234","BAY2402234 is a potent and selective small molecule inhibitor of dihydroorotate dehydrogenase. A solution of BAY2402234 will be available to initiate the trial and there are plans to transition to a tablet form of BAY2402234 once it becomes available. Both liquid and tablet formulations of BAY2402234 will be continually administered once daily by mouth in 28 day cycles.",null,"Dose Escalation|Dose Expansion: AML|Dose Expansion: MDS","\n\n * Patients with relapsed or refractory AML. Relapsed AML is defined as relapse after achieving a response to initial therapy and refractory AML is defined as failure to achieve a response after one previous line of therapy. Response is defined as per IWG criteria (CR, CRi or CRp). Patients who are not candidates to receive or who decline standard of care therapy are also eligible.\n * Patients with intermediate-1 or higher risk MDS who have failed therapy with a hypomethylating agent, or have failed lenalidomide therapy if harboring a 5q-chromosomal deletion.\n * Patients with relapsed/refractory CMML.\n * Estimated glomerular filtration rate (eGFR) > 40 mL per 1.73 m*2\n * Patients must have adequate coagulation (international normalized ratio [INR] â‰¤ 1.5; activated partial thromboplastin time [aPTT] â‰¤1.5 X the upper limit of normal [ULN]; patients on chronic anticoagulation therapy at investigator's discretion; patients on chronic use of direct-acting oral anticoagulants who have acceptable benefit-risk ratio at investigator's discretion)\n * Adequate liver function (total bilirubin â‰¤1.5 X ULN (or â‰¤3 X ULN in patients with documented Gilbert's syndrome or for patients with hyperbilirubinemia considered due to myeloid disease), alanine aminotransferase [ALT] and aspartate aminotransferase [AST] â‰¤3 X ULN (or â‰¤5 X ULN for patients with liver involvement of their myeloid disease)\n\n","\n\n * Patients eligible for hematopoietic stem cell transplantation\n * Clinical symptoms suggesting active central nervous system (CNS) leukemia or known CNS leukemia\n * Human immunodeficiency virus (HIV) infection\n * Chronic or active hepatitis B or C if not controlled by antiviral therapy\n * History of organ allograft (allogeneic bone marrow or stem cell transplant) within 3 months prior to first dose of study drug\n * Serious, uncontrolled infection requiring systemic antibiotic, antifungal or antiviral therapy. Prophylactic antibiotic, antifungal and/or antiviral therapy is permitted\n * Left ventricular ejection fraction (LVEF) <40%","CRP|EGFR","C-reactive protein|epidermal growth factor receptor","Protein","Breast|Ovary, Breast, Lung","Actual","2018-01-19","Actual","Anticipated","2021-09-03","Anticipated","2019-10-01","2017-11-29","2018-01-12","2019-10-24","No","Acute myeloid leukemia\nMyelodysplastic Syndromes\nChronic myelomonocytic leukemia\nDihydroorotate dehydrogenase (DHODH) inhibitor","Interventional","Treatment","Single Group Assignment","None (Open Label)","Non-Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"2017-002896-24","EudraCT Number","Maximum tolerated dose|Number of Adverse Events as a measure of safety and tolerability|AUC (0-24) (Area under the curve)|Cmax (Maximum concentration)","Phase 1 dose escalation study with increasing doses of study drug (BAY2402234). Maximum tolerated dose will be defined as the maximum dose administered during Cycle 1 at which the incidence of dose limiting toxicities is closest to 30%.|Up to 6 months on average|Pre-dose, 0.5, 1, 2, 4, 6, 8, 12 hours after dose administration at Cycle 1 Day 1 and Cycle 1 Day 15","Up to 42 days after the first dose","Composite endpoint: Number of AML patients with complete remission (CR) and complete response with partial recovery of peripheral blood counts (CRh)|Change in erythroid response as Histological Improvement criteria for patients with MDS and CMML|Change in platelet response as Histological Improvement criteria for patients with MDS and CMML|Change in neutrophil response as Histological Improvement criteria for patients with MDS and CMML","Response criteria according to modified IWG 2003. CRh is defined as <5% of blasts in the bone marrow, no evidence of disease, and partial recovery of peripheral blood counts (platelets >50,000/microliter and ANC >500/microliter)|Response criteria according to IWG 2006.","Up to 6 months on average|Every month until disease progression or patient is withdrawn from study, up to 6 months on average","clinical-trials-contact@bayer.com","Bayer Clinical Trials Contact","(+) 1-888-8422937","Villejuif Cedex, France, 94805|Bronx, New York, United States, 10467-2490 Memorial Sloan-Kettering Cancer CenterNew York, New York, United States, 10065|Philadelphia, Pennsylvania, United States, 19107|Nashville, Tennessee, United States, 37232","New York|Pennsylvania|Tennessee","France|United States","Institut Gustave Roussy|Montefiore Medical Center|Thomas Jefferson University|Vanderbilt University Medical Center",{"$nulls":4},"2019-10-24","2020-05-25T16:37:39.849","2020-05-26T17:10:42.972","NCT03404726"]
["5ecbf45311702c1b1b916add","NCT03404726","2019-11-21","Bayer","BAYN","Recruiting","A Study to Investigate BAY2402234, a Dihydroorotate Dehydrogenase (DHODH) Inhibitor, in Myeloid Malignancies","Bay-2402234","DHODH Inhibitor","Yes","['Bay-2402234']","No",null,"Phase 1",3,120,"Anticipated","2018-03-29","2021-04-12","MTD|AUC","Maximum Tolerated Dose|Area Under The Curve",{"$nulls":3},"The primary objective is to determine the safety, tolerability, pharmacokinetics, maximum tolerated dose (MTD), or pharmacological active dose (PAD) of BAY2402234 in patients with acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), or chronic myelomonocytic leukemia (CMML).\n\nThe secondary objective is to evaluate evidence of clinical efficacy associated with BAY2402234 in patients with AML (defined as Complete remission, Complete remission with partial hematologic recovery), and MDS (defined as hematological improvement).",null,"An Open-label, Multicenter Phase 1 Study to Characterize the Safety, Tolerability, Preliminary Antileukemic Activity, Pharmacokinetics, and Maximum Tolerated Dose or Pharmacological Active Dose of BAY2402234 in Patients With Advanced Myeloid Malignancies",19420,"Leukemia","Leukemia","Oncology Hematological","Oncology","Experimental","Dose Escalation|Dose Expansion: AML|Dose Expansion: MDS","Dose escalation with sequential cohorts enrolling patients with AML, MDS, or CMML. Patients will be treated in 28-day cycles with once daily oral administration of BAY2402234|After completion of dose escalation, an expansion cohort comprised of patients with AML will start. These patients will be treated in 28 day cycles with once daily oral administration of BAY2402234 at the maximum tolerated dose or pharmacologically active dose.|After completion of dose escalation, an expansion cohort comprised of patients with MDS will start. These patients will be treated in 28 day cycles with once daily oral administration of BAY2402234 at the maximum tolerated dose or pharmacologically active dose.","Drug","BAY2402234","BAY2402234 is a potent and selective small molecule inhibitor of dihydroorotate dehydrogenase. A solution of BAY2402234 will be available to initiate the trial and there are plans to transition to a tablet form of BAY2402234 once it becomes available. Both liquid and tablet formulations of BAY2402234 will be continually administered once daily by mouth in 28 day cycles.",null,"Dose Escalation|Dose Expansion: AML|Dose Expansion: MDS","\n\n * Patients with relapsed or refractory AML. Relapsed AML is defined as relapse after achieving a response to initial therapy and refractory AML is defined as failure to achieve a response after one previous line of therapy. Response is defined as per IWG criteria (CR, CRi or CRp). Patients who are not candidates to receive or who decline standard of care therapy are also eligible.\n * Patients with intermediate-1 or higher risk MDS who have failed therapy with a hypomethylating agent, or have failed lenalidomide therapy if harboring a 5q-chromosomal deletion.\n * Patients with relapsed/refractory CMML.\n * Estimated glomerular filtration rate (eGFR) > 40 mL per 1.73 m*2\n * Patients must have adequate coagulation (international normalized ratio [INR] â‰¤ 1.5; activated partial thromboplastin time [aPTT] â‰¤1.5 X the upper limit of normal [ULN]; patients on chronic anticoagulation therapy at investigator's discretion; patients on chronic use of direct-acting oral anticoagulants who have acceptable benefit-risk ratio at investigator's discretion)\n * Adequate liver function (total bilirubin â‰¤1.5 X ULN (or â‰¤3 X ULN in patients with documented Gilbert's syndrome or for patients with hyperbilirubinemia considered due to myeloid disease), alanine aminotransferase [ALT] and aspartate aminotransferase [AST] â‰¤3 X ULN (or â‰¤5 X ULN for patients with liver involvement of their myeloid disease)\n\n","\n\n * Patients eligible for hematopoietic stem cell transplantation\n * Clinical symptoms suggesting active central nervous system (CNS) leukemia or known CNS leukemia\n * Human immunodeficiency virus (HIV) infection\n * Chronic or active hepatitis B or C if not controlled by antiviral therapy\n * History of organ allograft (allogeneic bone marrow or stem cell transplant) within 3 months prior to first dose of study drug\n * Serious, uncontrolled infection requiring systemic antibiotic, antifungal or antiviral therapy. Prophylactic antibiotic, antifungal and/or antiviral therapy is permitted\n * Left ventricular ejection fraction (LVEF) <40%","CRP|EGFR","C-reactive protein|epidermal growth factor receptor","Protein","Breast|Ovary, Breast, Lung","Actual","2018-01-19","Actual","Anticipated","2021-09-03","Anticipated","2019-11-01","2017-11-29","2018-01-12","2019-11-19","No","Acute myeloid leukemia\nMyelodysplastic Syndromes\nChronic myelomonocytic leukemia\nDihydroorotate dehydrogenase (DHODH) inhibitor","Interventional","Treatment","Single Group Assignment","None (Open Label)","Non-Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"2017-002896-24","EudraCT Number","Maximum tolerated dose|Number of Adverse Events as a measure of safety and tolerability|AUC (0-24) (Area under the curve)|Cmax (Maximum concentration)","Phase 1 dose escalation study with increasing doses of study drug (BAY2402234). Maximum tolerated dose will be defined as the maximum dose administered during Cycle 1 at which the incidence of dose limiting toxicities is closest to 30%.|Up to 6 months on average|Pre-dose, 0.5, 1, 2, 4, 6, 8, 12 hours after dose administration at Cycle 1 Day 1 and Cycle 1 Day 15","Up to 42 days after the first dose","Composite endpoint: Number of AML patients with complete remission (CR) and complete response with partial recovery of peripheral blood counts (CRh)|Change in erythroid response as Histological Improvement criteria for patients with MDS and CMML|Change in platelet response as Histological Improvement criteria for patients with MDS and CMML|Change in neutrophil response as Histological Improvement criteria for patients with MDS and CMML","Response criteria according to modified IWG 2003. CRh is defined as <5% of blasts in the bone marrow, no evidence of disease, and partial recovery of peripheral blood counts (platelets >50,000/microliter and ANC >500/microliter)|Response criteria according to IWG 2006.","Up to 6 months on average|Every month until disease progression or patient is withdrawn from study, up to 6 months on average","clinical-trials-contact@bayer.com","Bayer Clinical Trials Contact","(+) 1-888-8422937","Villejuif Cedex, France, 94805|Bronx, New York, United States, 10467-2490 Memorial Sloan-Kettering Cancer CenterNew York, New York, United States, 10065|Philadelphia, Pennsylvania, United States, 19107|Nashville, Tennessee, United States, 37232","New York|Pennsylvania|Tennessee","France|United States","Institut Gustave Roussy|Montefiore Medical Center|Thomas Jefferson University|Vanderbilt University Medical Center",{"$nulls":4},"2019-11-19","2020-05-25T16:37:39.737","2020-05-26T17:10:42.972","NCT03404726"]
["5ecbf45411702c1b1b916ade","NCT03404726","2020-03-16","Bayer","BAYN","Recruiting","A Study to Investigate BAY2402234, a Dihydroorotate Dehydrogenase (DHODH) Inhibitor, in Myeloid Malignancies","Bay-2402234","DHODH Inhibitor","Yes","['Bay-2402234']","No",null,"Phase 1",3,120,"Anticipated","2018-03-29","2021-11-10","MTD|AUC","Maximum Tolerated Dose|Area Under The Curve",{"$nulls":3},"The primary objective is to determine the safety, tolerability, pharmacokinetics, maximum tolerated dose (MTD), or pharmacological active dose (PAD) of BAY2402234 in patients with acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), or chronic myelomonocytic leukemia (CMML).\n\nThe secondary objective is to evaluate evidence of clinical efficacy associated with BAY2402234 in patients with AML (defined as Complete remission, Complete remission with partial hematologic recovery), and MDS (defined as hematological improvement).",null,"An Open-label, Multicenter Phase 1 Study to Characterize the Safety, Tolerability, Preliminary Antileukemic Activity, Pharmacokinetics, and Maximum Tolerated Dose or Pharmacological Active Dose of BAY2402234 in Patients With Advanced Myeloid Malignancies",19420,"Leukemia","Leukemia","Oncology Hematological","Oncology","Experimental","Dose Escalation|Dose Expansion: AML|Dose Expansion: MDS","Dose escalation with sequential cohorts enrolling patients with AML, MDS, or CMML. Patients will be treated in 28-day cycles with once daily oral administration of BAY2402234|After completion of dose escalation, an expansion cohort comprised of patients with AML will start. These patients will be treated in 28 day cycles with once daily oral administration of BAY2402234 at the maximum tolerated dose or pharmacologically active dose.|After completion of dose escalation, an expansion cohort comprised of patients with MDS will start. These patients will be treated in 28 day cycles with once daily oral administration of BAY2402234 at the maximum tolerated dose or pharmacologically active dose.","Drug","BAY2402234","BAY2402234 is a potent and selective small molecule inhibitor of dihydroorotate dehydrogenase. A solution of BAY2402234 will be available to initiate the trial and there are plans to transition to a tablet form of BAY2402234 once it becomes available. Both liquid and tablet formulations of BAY2402234 will be continually administered once daily by mouth in 28 day cycles.",null,"Dose Escalation|Dose Expansion: AML|Dose Expansion: MDS","\n\n * Patients with relapsed or refractory AML. Relapsed AML is defined as relapse after achieving a response to initial therapy and refractory AML is defined as failure to achieve a response after one previous line of therapy. Response is defined as per IWG criteria (CR, CRi or CRp). Patients who are not candidates to receive or who decline standard of care therapy are also eligible.\n * Patients with intermediate-1 or higher risk MDS who have failed therapy with a hypomethylating agent, or have failed lenalidomide therapy if harboring a 5q-chromosomal deletion.\n * Patients with relapsed/refractory CMML.\n * Estimated glomerular filtration rate (eGFR) > 40 mL per 1.73 m*2\n * Patients must have adequate coagulation (international normalized ratio [INR] â‰¤ 1.5; activated partial thromboplastin time [aPTT] â‰¤1.5 X the upper limit of normal [ULN]; patients on chronic anticoagulation therapy at investigator's discretion; patients on chronic use of direct-acting oral anticoagulants who have acceptable benefit-risk ratio at investigator's discretion)\n * Adequate liver function (total bilirubin â‰¤1.5 X ULN (or â‰¤3 X ULN in patients with documented Gilbert's syndrome or for patients with hyperbilirubinemia considered due to myeloid disease), alanine aminotransferase [ALT] and aspartate aminotransferase [AST] â‰¤3 X ULN (or â‰¤5 X ULN for patients with liver involvement of their myeloid disease)\n\n","\n\n * Patients eligible for hematopoietic stem cell transplantation\n * Clinical symptoms suggesting active central nervous system (CNS) leukemia or known CNS leukemia\n * Human immunodeficiency virus (HIV) infection\n * Chronic or active hepatitis B or C if not controlled by antiviral therapy\n * History of organ allograft (allogeneic bone marrow or stem cell transplant) within 3 months prior to first dose of study drug\n * Serious, uncontrolled infection requiring systemic antibiotic, antifungal or antiviral therapy. Prophylactic antibiotic, antifungal and/or antiviral therapy is permitted\n * Left ventricular ejection fraction (LVEF) <40%","CRP|EGFR","C-reactive protein|epidermal growth factor receptor","Protein","Breast|Ovary, Breast, Lung","Actual","2018-01-19","Actual","Anticipated","2022-11-10","Anticipated","2020-03-01","2017-11-29","2018-01-12","2020-03-13","No","Acute myeloid leukemia\nMyelodysplastic Syndromes\nChronic myelomonocytic leukemia\nDihydroorotate dehydrogenase (DHODH) inhibitor","Interventional","Treatment","Single Group Assignment","None (Open Label)","Non-Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"2017-002896-24","EudraCT Number","Maximum tolerated dose|Number of Adverse Events as a measure of safety and tolerability|AUC (0-24) (Area under the curve)|Cmax (Maximum concentration)","Phase 1 dose escalation study with increasing doses of study drug (BAY2402234). Maximum tolerated dose will be defined as the maximum dose administered during Cycle 1 at which the incidence of dose limiting toxicities is closest to 30%.|Up to 6 months on average|Pre-dose, 0.5, 1, 2, 4, 6, 8, 12 hours after dose administration at Cycle 1 Day 1 and Cycle 1 Day 15","Up to 42 days after the first dose","Composite endpoint: Number of AML patients with complete remission (CR) and complete response with partial recovery of peripheral blood counts (CRh)|Change in erythroid response as Histological Improvement criteria for patients with MDS and CMML|Change in platelet response as Histological Improvement criteria for patients with MDS and CMML|Change in neutrophil response as Histological Improvement criteria for patients with MDS and CMML","Response criteria according to modified IWG 2003. CRh is defined as <5% of blasts in the bone marrow, no evidence of disease, and partial recovery of peripheral blood counts (platelets >50,000/microliter and ANC >500/microliter)|Response criteria according to IWG 2006.","Up to 6 months on average|Every month until disease progression or patient is withdrawn from study, up to 6 months on average","clinical-trials-contact@bayer.com","Bayer Clinical Trials Contact","(+) 1-888-8422937","Villejuif Cedex, France, 94805|Bronx, New York, United States, 10467-2490 Memorial Sloan-Kettering Cancer CenterNew York, New York, United States, 10065|Philadelphia, Pennsylvania, United States, 19107|Nashville, Tennessee, United States, 37232","New York|Pennsylvania|Tennessee","France|United States","Institut Gustave Roussy|Montefiore Medical Center|Thomas Jefferson University|Vanderbilt University Medical Center",{"$nulls":4},"2020-03-13","2020-05-25T16:37:40.276","2020-05-26T17:10:42.972","NCT03404726"]
["5ecbf454307e3d1b1f8d9d5f","NCT03404726","2020-04-09","Bayer","BAYN","Recruiting","A Study to Investigate BAY2402234, a Dihydroorotate Dehydrogenase (DHODH) Inhibitor, in Myeloid Malignancies","Bay-2402234","DHODH Inhibitor","Yes","['Bay-2402234']","No",null,"Phase 1",3,120,"Anticipated","2018-03-29","2021-11-10","MTD|AUC","Maximum Tolerated Dose|Area Under The Curve",{"$nulls":3},"The primary objective is to determine the safety, tolerability, pharmacokinetics, maximum tolerated dose (MTD), or pharmacological active dose (PAD) of BAY2402234 in patients with acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), or chronic myelomonocytic leukemia (CMML).\n\nThe secondary objective is to evaluate evidence of clinical efficacy associated with BAY2402234 in patients with AML (defined as Complete remission, Complete remission with partial hematologic recovery), and MDS (defined as hematological improvement).",null,"An Open-label, Multicenter Phase 1 Study to Characterize the Safety, Tolerability, Preliminary Antileukemic Activity, Pharmacokinetics, and Maximum Tolerated Dose or Pharmacological Active Dose of BAY2402234 in Patients With Advanced Myeloid Malignancies",19420,"Leukemia","Leukemia","Oncology Hematological","Oncology","Experimental","Dose Escalation|Dose Expansion: AML|Dose Expansion: MDS","Dose escalation with sequential cohorts enrolling patients with AML, MDS, or CMML. Patients will be treated in 28-day cycles with once daily oral administration of BAY2402234|After completion of dose escalation, an expansion cohort comprised of patients with AML will start. These patients will be treated in 28 day cycles with once daily oral administration of BAY2402234 at the maximum tolerated dose or pharmacologically active dose.|After completion of dose escalation, an expansion cohort comprised of patients with MDS will start. These patients will be treated in 28 day cycles with once daily oral administration of BAY2402234 at the maximum tolerated dose or pharmacologically active dose.","Drug","BAY2402234","BAY2402234 is a potent and selective small molecule inhibitor of dihydroorotate dehydrogenase. A solution of BAY2402234 will be available to initiate the trial and there are plans to transition to a tablet form of BAY2402234 once it becomes available. Both liquid and tablet formulations of BAY2402234 will be continually administered once daily by mouth in 28 day cycles.",null,"Dose Escalation|Dose Expansion: AML|Dose Expansion: MDS","\n\n * Patients with relapsed or refractory AML. Relapsed AML is defined as relapse after achieving a response to initial therapy and refractory AML is defined as failure to achieve a response after one previous line of therapy. Response is defined as per IWG criteria (CR, CRi or CRp). Patients who are not candidates to receive or who decline standard of care therapy are also eligible.\n * Patients with intermediate-1 or higher risk MDS who have failed therapy with a hypomethylating agent, or have failed lenalidomide therapy if harboring a 5q-chromosomal deletion.\n * Patients with relapsed/refractory CMML.\n * Estimated glomerular filtration rate (eGFR) > 40 mL per 1.73 m*2\n * Patients must have adequate coagulation (international normalized ratio [INR] â‰¤ 1.5; activated partial thromboplastin time [aPTT] â‰¤1.5 X the upper limit of normal [ULN]; patients on chronic anticoagulation therapy at investigator's discretion; patients on chronic use of direct-acting oral anticoagulants who have acceptable benefit-risk ratio at investigator's discretion)\n * Adequate liver function (total bilirubin â‰¤1.5 X ULN (or â‰¤3 X ULN in patients with documented Gilbert's syndrome or for patients with hyperbilirubinemia considered due to myeloid disease), alanine aminotransferase [ALT] and aspartate aminotransferase [AST] â‰¤3 X ULN (or â‰¤5 X ULN for patients with liver involvement of their myeloid disease)\n\n","\n\n * Patients eligible for hematopoietic stem cell transplantation\n * Clinical symptoms suggesting active central nervous system (CNS) leukemia or known CNS leukemia\n * Human immunodeficiency virus (HIV) infection\n * Chronic or active hepatitis B or C if not controlled by antiviral therapy\n * History of organ allograft (allogeneic bone marrow or stem cell transplant) within 3 months prior to first dose of study drug\n * Serious, uncontrolled infection requiring systemic antibiotic, antifungal or antiviral therapy. Prophylactic antibiotic, antifungal and/or antiviral therapy is permitted\n * Left ventricular ejection fraction (LVEF) <40%","CRP|EGFR","C-reactive protein|epidermal growth factor receptor","Protein","Breast|Ovary, Breast, Lung","Actual","2018-01-19","Actual","Anticipated","2022-11-10","Anticipated","2020-04-01","2017-11-29","2018-01-12","2020-04-08","No","Acute myeloid leukemia\nMyelodysplastic Syndromes\nChronic myelomonocytic leukemia\nDihydroorotate dehydrogenase (DHODH) inhibitor","Interventional","Treatment","Single Group Assignment","None (Open Label)","Non-Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"2017-002896-24","EudraCT Number","Maximum tolerated dose|Number of Adverse Events as a measure of safety and tolerability|AUC (0-24) (Area under the curve)|Cmax (Maximum concentration)","Phase 1 dose escalation study with increasing doses of study drug (BAY2402234). Maximum tolerated dose will be defined as the maximum dose administered during Cycle 1 at which the incidence of dose limiting toxicities is closest to 30%.|Up to 6 months on average|Pre-dose, 0.5, 1, 2, 4, 6, 8, 12 hours after dose administration at Cycle 1 Day 1 and Cycle 1 Day 15","Up to 42 days after the first dose","Composite endpoint: Number of AML patients with complete remission (CR) and complete response with partial recovery of peripheral blood counts (CRh)|Change in erythroid response as Histological Improvement criteria for patients with MDS and CMML|Change in platelet response as Histological Improvement criteria for patients with MDS and CMML|Change in neutrophil response as Histological Improvement criteria for patients with MDS and CMML","Response criteria according to modified IWG 2003. CRh is defined as <5% of blasts in the bone marrow, no evidence of disease, and partial recovery of peripheral blood counts (platelets >50,000/microliter and ANC >500/microliter)|Response criteria according to IWG 2006.","Up to 6 months on average|Every month until disease progression or patient is withdrawn from study, up to 6 months on average","clinical-trials-contact@bayer.com","Bayer Clinical Trials Contact","(+) 1-888-8422937","Villejuif Cedex, France, 94805|Bronx, New York, United States, 10467-2490 Memorial Sloan-Kettering Cancer CenterNew York, New York, United States, 10065|Philadelphia, Pennsylvania, United States, 19107|Nashville, Tennessee, United States, 37232","New York|Pennsylvania|Tennessee","France|United States","Institut Gustave Roussy|Montefiore Medical Center|Thomas Jefferson University|Vanderbilt University Medical Center",{"$nulls":4},"2020-04-08","2020-05-25T16:37:40.263","2020-05-26T17:10:42.972","NCT03404726"]
["5ecbf45cfeab101b15530910","NCT03405441","2018-01-23","Johnson & Johnson","JNJ","Recruiting","A Study to Investigate Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-55375515 in Healthy Male Participants","Jnj-55375515",null,"Yes","['Jnj-55375515']","Unknown",null,"Phase 1",3,52,"Anticipated","2018-01-02","2018-07-10",{"$nulls":5},"The purpose of this study is to assess safety and tolerability of day-time and night-time dosing of JNJâ€‘55375515 in healthy male participants.",null,"A 2-Part, Randomized, Placebo-controlled, Double-blind, Single Ascending Dose Study to Investigate Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-55375515 in Healthy Male Subjects","CR108409","Healthy","Healthy Volunteers","Healthy","Healthy","Experimental","Part 1 (Panel 1): JNJ-55375515 and placebo|Part 1 (Panel 2): JNJ-55375515 and placebo|Part 2: JNJ-55375515 and placebo","Participants will receive dose level (DL) 1 of JNJ-55375515 (starting dose) or placebo on Day 1 of period 1 based on their randomization sequence 1, 2 or 3. Dose of the study medication will be escalated to DL 3 (period 2) and a maximum of DL 5 (period 3) based on the safety and tolerability profile and pharmacodynamic (PD) profile assessed at the preceding dose level. A wash-out period of at least 10 days will be maintained between study drug administrations.|Participants will receive DL 2 of JNJ-55375515 (starting dose) or placebo on Day 1 of period 1 based on their randomization sequence 1, 2 or 3. Dose of the study medication will be escalated to DL 4 (period 2) and a maximum of DL 6 (period 3) based on the safety and tolerability profile and PD profile assessed at the preceding dose level. A wash-out period of at least 10 days will be maintained between study drug administrations.|Participants will randomly be assigned to one of four treatment sequences 1, 2, 3 or 4. In the first 3 sequences, participants will receive 2 doses of JNJ-55375515 and placebo. Participants assigned to sequence 4 will receive placebo only in all periods. 3 dose levels will be tested in Part 2 based on Part 1 and will not exceed those evaluated in Part 1. A wash-out period of at least 10 days will be maintained between study drug administrations in period 1, 2, 3 and 4. In period 4 (open-label pharmacokinetic (PK) assessment period) participants will be randomly assigned to one of two dose levels tested in periods 1 to 3.","Drug","JNJ-55375515 Dose Level 1|JNJ-55375515 Dose Level 3|JNJ-55375515 Dose Level 5|Placebo|JNJ-55375515 Dose Level 2|JNJ-55375515 Dose Level 4|JNJ-55375515 Dose Level 6|JNJ-55375515","Participants will receive JNJ-55375515 orally at a Dose level 1 in Part 1 of study.|Participants will receive JNJ-55375515 orally at a Dose level 3 in Part 1 of study.|Participants will receive JNJ-55375515 orally at a Dose level 5 in Part 1 of study.|All participants will receive matching placebo orally in Part 1 and Part 2 of the study.|Participants will receive JNJ-55375515 orally at a Dose level 2 in Part 1 of study.|Participants will receive JNJ-55375515 orally at a Dose level 4 in Part 1 of study.|Participants will receive JNJ-55375515 orally at a Dose level 6 in Part 1 of study.|Participants will receive JNJ-55375515 as per the assigned treatment in Part 2.",null,"Part 1 (Panel 1): JNJ-55375515 and placebo|Part 1 (Panel 2): JNJ-55375515 and placebo|Part 2: JNJ-55375515 and placebo","\n\n * Body Mass Index (BMI) between 18 and 30 kilogram / square meter (kg/m^2) inclusive (BMI=weight/height^2)\n * Participant must be healthy based on clinical laboratory tests performed at screening. If the results of the serum chemistry panel, hematology, coagulation or urinalysis are outside the normal reference ranges, retesting of an abnormal lab value (s) that may lead to exclusion will be allowed once during the screening phase. It is expected that laboratory values will generally be within the normal range for the laboratory, though minor deviations, which are not considered to be of clinical significance to the investigator, are acceptable\n * Participant must be healthy based on physical and neurological examination, medical history, vital signs, and 12-lead Electrocardiography (ECG) [including QTcF less than or equal to (<=) 450 millisecond (msec)] performed at screening, admission to the clinical unit and pre dose on Day 1 of Period 1. Abnormalities, which are not considered to be of clinical significance by the investigator, are acceptable. The presence of Left Bundle Branch Block (LBBB), AV Block (second degree or higher), or a permanent pacemaker or implantable cardioverter defibrillator [ICD] will lead to exclusion\n * Non-smoker (not smoked for 3 months prior to screening)\n * During the study and for a minimum of 1 spermatogenesis cycle (defined as approximately 90 days) after receiving the last dose of study drug, in addition to the highly effective method of contraception, a man who is sexually active with a woman of childbearing potential must agree to use a barrier method of contraception (for example, condom with spermicidal foam/gel/film/cream/suppository); who is sexually active with a woman who is pregnant must use a condom; must agree not to donate sperm\n\n","\n\n * History of or current significant medical illness including (but not limited to psychotic, bipolar, major depressive, or anxiety disorder)\n * Cardiac arrhythmias or other cardiac disease, hematological disease, lipid abnormalities, respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, Parkinson's disease, infection, or any other illness that the Investigator considers should exclude the participant\n * Serology positive for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies or human immunodeficiency virus (HIV) antibodies\n * Participant has a history of or current vestibular disease including (but not limited to) Meniere's disease, benign paroxysmal positional vertigo (BPPV), vestibular neuronitis, vestibular schwannoma or vestibular migraine\n * Only for part 2: Has a current diagnosis or history of narcolepsy, central sleep apnea, sleep related hypoventilation, circadian rhythm sleep-wake disorders, substance/medication induced sleep disorder or parasomnias (non-rapid eye movement sleep arousal disorders, nightmare disorder, rapid eye movement sleep behavior disorder); obstructive sleep apnea/hypopnea (apnea/hypopnea index greater than (>)10) or restless legs syndrome (periodic leg movements with arousal index >15); night-shift worker or significantly shifted diurnal activity pattern (it is expected that eligible participant normally wake up between 6:00 am - 8:00 am and go to bed between 10:00 pm - 12:00 am); usual bedtime outside of 10:00 pm and 12:00 am and taking, on average, less than 6 hours or more than 9 hours of bed rest",{"$nulls":4},"Actual","2018-01-23","Actual","Anticipated","2018-07-10","Anticipated","2018-01-01","2018-01-08","2018-01-19","2018-01-19","No",null,"Interventional","Treatment","Crossover Assignment","Double (Participant, Investigator)","Randomized","18 Years","54 Years","Male",null,"Yes",null,null,"URL: http://pam.sylogent.com/cr/CR108409 [http://pam.sylogent.com/cr/CR108409] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To learn how to participate in this trial please click here.",null,"No","No",{"$nulls":17},"55375515EDI1002|2017-002457-11","Janssen Research & Development, LLC|EudraCT Number","Part 1 (Day-Time Dosing): Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability|Part 2 (Night-Time Dosing): Number of Participants with AEs as a Measure of Safety and Tolerability","An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.","Up to Week 8|Up to Week 9","Slow Wave Activity Recorded by the Electroencephalogram (EEG)|Part 1: PD of JNJ-55375515 as Assessed by Heart Rate Variability (HRV)|Part 1: Saccadic Reaction Time (RT) as Measured by Saccadic Eye Movements|Part 1: Saccadic Peak Velocity (SPV) as Measured by Saccadic Eye Movements|Part 1: Change from Baseline in Body Sway|Part 1 and 2: PD as Assessed by Karolinska Sleepiness Scale (KSS) Score|Part 1: Change from Baseline in Bond and Lader Visual Analogue Scale (B&L VAS) Score|Part 1 and 2: Change from Baseline in Cortisol Levels|Part 1: PD as Assessed by Probabilistic Instrumental Learning Task (PILT)|Part 1: PD as Assessed by Cognitive Test Battery: International Shopping List Test|Part 1: PD as Assessed by Cognitive Test Battery: Groton Maze Learning Task|Part 1: PD as Assessed by Cognitive Test Battery: Social Emotional Cognition Task|Part 1: PD as Assessed by Cognitive Test Battery: Detection Task|Part 1: PD as Assessed by Cognitive Test Battery: Identification Task|Part 1: PD as Assessed by Cognitive Test Battery: one Back Task|Part 1: PD as Assessed by Cognitive Test Battery: International Shopping List Test - Delayed Recall|Part 1: PD as Assessed by Cognitive Test Battery: Groton Maze Learning - Delayed Recall|Part 1: Evoked Stress Response as Assessed by Induced Stress|Part 2: Latency to Persistent Sleep (LPS) by 8-hour Overnight Polysomnography|Part 2: Total Time Spent in Deep Sleep (Duration of Slow Wave Sleep) - Stage 3 Sleep by 8-Hour Overnight Polysomnography|Part 2: Time in bed by 8-hour Overnight Polysomnography|Part 2: Cognitive Test Battery: Continuous Paired Associate Learning Task (CPAL)|Part 1 and 2: Maximum Observed Plasma Concentration (Cmax)|Part 1 and 2: Time to Reach Maximum Observed Plasma Concentration (Tmax)|Part 1 and 2: Area Under the Plasma Concentration-Time Curve from Time 0 to Time of the Last Quantifiable Concentrations (AUC[0-last])","The Effect of JNJ-55375515 on slow wave activity recorded by the electroencephalogram (EEG) will be evaluated. EEG recordings are made using gold electrodes, fixed at Midline Frontal Electrode (Fz), Midline Central Electrode (Cz), Midline Parietal Electrode (Pz) and Midline Occipital Electrode (Oz), with the same common ground electrode as for the eye movement registration (international 10/20 system). Per session eight consecutive blocks of eight seconds are recorded. For each lead, fast Fourier transform analysis will be performed to obtain the sum of amplitudes in the very low (0.5-2 Hertz|Heart rate variability (HRV) is the physiological phenomenon of variation in the time interval between heartbeats. It is measured by the variation in the beat-to-beat interval. HRV will be derived from Holter recordings. Holter recordings will start pre dose on Day 1 of each period in Part 1 and continue for 24 hours. Measurements will be made at rest (during 5 minutes) and HRV parameters will be derived from these 5-minute recordings and from the 24-hour recordings.|Saccadic eye movements will be recorded to measure saccadic reaction time (RT). The recording and analysis of saccadic eye movements is performed using a computer-based system for sampling and analysis of eye movements. In a typical test system, electrodes are applied on the forehead and beside the lateral canthi of both eyes of the participant for registration of the electro-oculographic signals. Head movements are restrained using a fixed head support. The target consists of a moving dot that is displayed on a computer screen. Fifteen saccades are recorded with inter-stimulus intervals varying randomly between 3 and 6 seconds. Average values of latency (reaction time) of all correct saccades will be assessed.|Saccadic eye movements will be recorded to measure saccadic peak velocity (SPV). The recording and analysis of saccadic eye movements is performed using a computer-based system for sampling and analysis of eye movements. In a typical test system, electrodes are applied on the forehead and beside the lateral canthi of both eyes of the participant for registration of the electro-oculographic signals. Head movements are restrained using a fixed head support. The target consists of a moving dot that is displayed on a computer screen. Fifteen saccades are recorded with inter-stimulus intervals varying randomly between 3 and 6 seconds. Average values of saccadic peak velocity of all correct saccades will be assessed.|The body sway meter allows measurement of body movements in a single plane, providing a measure of postural stability. Body sway may be measured with a pot string meter (Celesco) based on the Wright ataxiameter or platform. Participants will be instructed to wear a pair of comfortable, low-heeled shoes on each session. The total period of body-sway measurement will be 2 minutes.|The KSS is a patient reported assessment of drowsiness level at the time of scale administration. This scale is focused mainly on the propensity to fall asleep and has a high validity in assessing sleepiness. It consists of a 9-point Likert scale with response options from: 1=very alert, 3=alert, 5=neither alert nor sleepy, 7=sleepy (but not fighting sleep), 9=very sleepy (fighting sleep).|The Bond and Lader Visual Analogue Scale consists of sixteen 100 millimeter (mm) visual analog scales anchored by antonyms (example, Alert-Drowsy, Lethargic-Energetic, etc). Scores will be combined to form three mood factors: alertness, calmness, and contentedness.|To establish diurnal levels of cortisol levels, repeated serum samples will be obtained throughout the Day 1 of each period. The diurnal cortisol levels will be explored to further clarify the effect of the compound on the hypothalamic-pituitary-adrenal-axis.|In this motivational processing task, participants with depressive symptoms may show a lower response bias towards a reward compared to healthy participants. The PILT allows the objective assessment of participants propensity to modulate behavior as a function of reward.|The International Shopping List Test is a measure of Verbal Memory-Learning. The test measures total number of correct responses remembering the 16-word list on three consecutive learning trials. Higher score indicates better performance.|Groton Maze Learning Task is a measure of Executive Function and Spatial Learning. The test measures total number of errors made while locating and learning 28 step pathway hidden beneath a 10*10 grid on 5 consecutive trials during a single session. Lower score indicates better performance.|To evaluate social and emotional cognition, a series of tests will be used to quantify both the ability to empathize and understand the emotions of others, and the ability to interpret their thoughts and intentions. A classical test involves the presentation of facial expressions and is asked to choose which word best describes what the person in the image is thinking or trying.|Detection task is a measure of Psychomotor Function. The test measures speed of performance; mean of the log10 transformed reaction times for correct responses. Lower score indicates better performance.|Identification task is a measure of Attention. The test measures speed of performance; mean of the log10 transformed reaction times for correct responses. Lower score indicates better performance.|One back task is a measure of Working Memory. The test measures speed of performance; mean of the log10 transformed reaction times for correct responses. Lower score indicates better performance.|International shopping list test - Delayed Recall is a measure of Delayed Verbal Memory. The test measures total number of correct responses recalling the 16 words learned previously after a delay. Higher score indicates better performance.|Groton Maze Learning - Delayed recall is a measure of Delayed Spatial Memory. The test measures number of errors made while locating 28 step pathway hidden beneath a 10*10 grid after a delay. Lower score indicates better performance.|The induced stress test consists of a highly demanding computer task that is performed for 20 minutes.|LPS is the time in minutes from 'lights out' that marks the starting of total recording time to the first epoch scored as sleep.|Polysomnographic recordings will be used to determine the total time spent in deep sleep (duration of slow wave sleep) -stage 3 sleep by 8-hour overnight.|Polysomnographic recordings will be used to determine the time in bed by 8-hour overnight.|The Continuous Paired Associate Learning (CPAL) test will be used to assess whether JNJâ€‘55375515 will improve performance of complex cognitive tasks. CPAL assess Visual episodic memory (associate learning) cognitive domain. In this task, participants must learn a series of associations between a set of difficult to verbalize patterns (amoeba) and locations. In healthy adults, 14 pattern/location associations must be learned. In the presentation phase of the task the pattern appears at the location and the participant is required to acknowledge that they have seen the pattern by touching the location at which it appears. Patterns are presented in random order. In the learning phase of the task, participants must place each of the 14 patterns in their correct locations. They must do this in 10 rounds. Number of errors made in correctly placing each of the four patterns in their location four times. (Lower score = better performance).|Cmax is the maximum observed plasma concentration.|Tmax is defined as actual sampling time to reach maximum observed analyte concentration.|AUC(0-last) is area under the plasma concentration-time curve from time 0 to time of the last quantifiable concentrations.","Hz), delta- (2-4 Hz), theta (4-7.5 Hz), alpha- (7.5-13.5 Hz), beta- (13.5-35 Hz), and gamma-(35-48.9 Hz) frequency ranges. The total test will last approximately 2 minutes.|Pre-dose (Day 1) up to 24 hours post dose|Pre-dose, 1 h, 2h, and 4h post dose on Day 1|Pre-dose, 1h, 2h, and 4h post dose on Day 1|Baseline, 1h, 2h, and 4h post dose on Day 1|Part 1: Pre-dose, 1h, 3h, and 8h post dose on Day 1; Part 2: Pre-dose (Day 1) and 8h post dose (Day 2)|Part 1: Baseline, 0.5h, 1h, 2h, 3h, 4h, 5h 45minutes (m), 6h, 6h 05m, 6h 25m, 6h 30m, 6h 50m, 6h 55m, 7h 15m, 7h 35m, 8h, 12h and 24h post dose on Day 1; Part 2: Baseline, 0.5h, 1h, 2h (Day 1 or 2), 3h, 4h, 6h, 8h, 12h and 24h post dose on Day 2|Pre-dose, 3h, and 8h post dose on Day 1|6h 30m to 6h 50m post dose on Day 1|0 hour (Day 1) up to 8 Hour (Day 2)|-7 hour (Day 1), 17 hour (Day 2)|Part 1: Pre-dose, 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 72h, and 96h post dose; Part 2: Pre dose, 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 46h, 70h, and 94h post dose|Part 1: Pre-dose, 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 72h, and 96h post dose; Part 2: Pre-dose, 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 46h, 70h, and 94h post dose","JNJ.CT@sylogent.com","Study Contact","844-434-4210","Groningen, Netherlands, 9728 Nz",null,"Netherlands","Pra Health Sciences Onderzoekscentrum Groningen, Locatie Martini",{"$nulls":3},"Janssen Research & Development, LLC Clinical Trial","2018-01-19","2020-05-25T16:37:48.166","2020-05-26T17:10:42.972","NCT03405441"]
["5ecbf45c11702c1b1b916af0","NCT03405441","2018-08-01","Johnson & Johnson","JNJ","Recruiting","A Study to Investigate Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-55375515 in Healthy Male Participants","Jnj-55375515",null,"Yes","['Jnj-55375515']","Unknown",null,"Phase 1",3,52,"Anticipated","2018-01-02","2018-09-10",{"$nulls":5},"The purpose of this study is to assess safety and tolerability of day-time and night-time dosing of JNJâ€‘55375515 in healthy male participants.",null,"A 2-Part, Randomized, Placebo-controlled, Double-blind, Single Ascending Dose Study to Investigate Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-55375515 in Healthy Male Subjects","CR108409","Healthy","Healthy Volunteers","Healthy","Healthy","Experimental","Part 1 (Panel 1): JNJ-55375515 and placebo|Part 1 (Panel 2): JNJ-55375515 and placebo|Part 2: JNJ-55375515 and placebo","Participants will receive dose level (DL) 1 of JNJ-55375515 (starting dose) or placebo on Day 1 of period 1 based on their randomization sequence 1, 2 or 3. Dose of the study medication will be escalated to DL 3 (period 2) and a maximum of DL 5 (period 3) based on the safety and tolerability profile and pharmacodynamic (PD) profile assessed at the preceding dose level. A wash-out period of at least 10 days will be maintained between study drug administrations.|Participants will receive DL 2 of JNJ-55375515 (starting dose) or placebo on Day 1 of period 1 based on their randomization sequence 1, 2 or 3. Dose of the study medication will be escalated to DL 4 (period 2) and a maximum of DL 6 (period 3) based on the safety and tolerability profile and PD profile assessed at the preceding dose level. A wash-out period of at least 10 days will be maintained between study drug administrations.|Participants will randomly be assigned to one of four treatment sequences 1, 2, 3 or 4. In the first 3 sequences, participants will receive 2 doses of JNJ-55375515 and placebo. Participants assigned to sequence 4 will receive placebo only in all periods. 3 dose levels will be tested in Part 2 based on Part 1 and will not exceed those evaluated in Part 1. A wash-out period of at least 10 days will be maintained between study drug administrations in period 1, 2, 3 and 4. In period 4 (open-label pharmacokinetic (PK) assessment period) participants will be randomly assigned to one of two dose levels tested in periods 1 to 3.","Drug","JNJ-55375515 Dose Level 1|JNJ-55375515 Dose Level 3|JNJ-55375515 Dose Level 5|Placebo|JNJ-55375515 Dose Level 2|JNJ-55375515 Dose Level 4|JNJ-55375515 Dose Level 6|JNJ-55375515","Participants will receive JNJ-55375515 orally at a Dose level 1 in Part 1 of study.|Participants will receive JNJ-55375515 orally at a Dose level 3 in Part 1 of study.|Participants will receive JNJ-55375515 orally at a Dose level 5 in Part 1 of study.|All participants will receive matching placebo orally in Part 1 and Part 2 of the study.|Participants will receive JNJ-55375515 orally at a Dose level 2 in Part 1 of study.|Participants will receive JNJ-55375515 orally at a Dose level 4 in Part 1 of study.|Participants will receive JNJ-55375515 orally at a Dose level 6 in Part 1 of study.|Participants will receive JNJ-55375515 as per the assigned treatment in Part 2.",null,"Part 1 (Panel 1): JNJ-55375515 and placebo|Part 1 (Panel 2): JNJ-55375515 and placebo|Part 2: JNJ-55375515 and placebo","\n\n * Body Mass Index (BMI) between 18 and 30 kilogram / square meter (kg/m^2) inclusive (BMI=weight/height^2)\n * Participant must be healthy based on clinical laboratory tests performed at screening. If the results of the serum chemistry panel, hematology, coagulation or urinalysis are outside the normal reference ranges, retesting of an abnormal lab value (s) that may lead to exclusion will be allowed once during the screening phase. It is expected that laboratory values will generally be within the normal range for the laboratory, though minor deviations, which are not considered to be of clinical significance to the investigator, are acceptable\n * Participant must be healthy based on physical and neurological examination, medical history, vital signs, and 12-lead Electrocardiography (ECG) [including QTcF less than or equal to (<=) 450 millisecond (msec)] performed at screening, admission to the clinical unit and pre dose on Day 1 of Period 1. Abnormalities, which are not considered to be of clinical significance by the investigator, are acceptable. The presence of Left Bundle Branch Block (LBBB), AV Block (second degree or higher), or a permanent pacemaker or implantable cardioverter defibrillator [ICD] will lead to exclusion\n * Non-smoker (not smoked for 3 months prior to screening)\n * During the study and for a minimum of 1 spermatogenesis cycle (defined as approximately 90 days) after receiving the last dose of study drug, in addition to the highly effective method of contraception, a man who is sexually active with a woman of childbearing potential must agree to use a barrier method of contraception (for example, condom with spermicidal foam/gel/film/cream/suppository); who is sexually active with a woman who is pregnant must use a condom; must agree not to donate sperm\n\n","\n\n * History of or current significant medical illness including (but not limited to psychotic, bipolar, major depressive, or anxiety disorder)\n * Cardiac arrhythmias or other cardiac disease, hematological disease, lipid abnormalities, respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, Parkinson's disease, infection, or any other illness that the Investigator considers should exclude the participant\n * Serology positive for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies or human immunodeficiency virus (HIV) antibodies\n * Participant has a history of or current vestibular disease including (but not limited to) Meniere's disease, benign paroxysmal positional vertigo (BPPV), vestibular neuronitis, vestibular schwannoma or vestibular migraine\n * Only for part 2: Has a current diagnosis or history of narcolepsy, central sleep apnea, sleep related hypoventilation, circadian rhythm sleep-wake disorders, substance/medication induced sleep disorder or parasomnias (non-rapid eye movement sleep arousal disorders, nightmare disorder, rapid eye movement sleep behavior disorder); obstructive sleep apnea/hypopnea (apnea/hypopnea index greater than (>)10) or restless legs syndrome (periodic leg movements with arousal index >15); night-shift worker or significantly shifted diurnal activity pattern (it is expected that eligible participant normally wake up between 6:00 am - 8:00 am and go to bed between 10:00 pm - 12:00 am); usual bedtime outside of 10:00 pm and 12:00 am and taking, on average, less than 6 hours or more than 9 hours of bed rest",{"$nulls":4},"Actual","2018-01-23","Actual","Anticipated","2018-09-10","Anticipated","2018-07-01","2018-01-08","2018-01-19","2018-07-31","No",null,"Interventional","Treatment","Crossover Assignment","Double (Participant, Investigator)","Randomized","18 Years","54 Years","Male",null,"Yes",null,null,"URL: http://pam.sylogent.com/cr/CR108409 [http://pam.sylogent.com/cr/CR108409] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To learn how to participate in this trial please click here.",null,"No","No",{"$nulls":17},"55375515EDI1002|2017-002457-11","Janssen Research & Development, LLC|EudraCT Number","Part 1 (Day-Time Dosing): Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability|Part 2 (Night-Time Dosing): Number of Participants with AEs as a Measure of Safety and Tolerability","An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.","Up to Week 8|Up to Week 9","Slow Wave Activity Recorded by the Electroencephalogram (EEG)|Part 1: PD of JNJ-55375515 as Assessed by Heart Rate Variability (HRV)|Part 1: Saccadic Reaction Time (RT) as Measured by Saccadic Eye Movements|Part 1: Saccadic Peak Velocity (SPV) as Measured by Saccadic Eye Movements|Part 1: Change from Baseline in Body Sway|Part 1 and 2: PD as Assessed by Karolinska Sleepiness Scale (KSS) Score|Part 1: Change from Baseline in Bond and Lader Visual Analogue Scale (B&L VAS) Score|Part 1 and 2: Change from Baseline in Cortisol Levels|Part 1: PD as Assessed by Probabilistic Instrumental Learning Task (PILT)|Part 1: PD as Assessed by Cognitive Test Battery: International Shopping List Test|Part 1: PD as Assessed by Cognitive Test Battery: Groton Maze Learning Task|Part 1: PD as Assessed by Cognitive Test Battery: Social Emotional Cognition Task|Part 1: PD as Assessed by Cognitive Test Battery: Detection Task|Part 1: PD as Assessed by Cognitive Test Battery: Identification Task|Part 1: PD as Assessed by Cognitive Test Battery: one Back Task|Part 1: PD as Assessed by Cognitive Test Battery: International Shopping List Test - Delayed Recall|Part 1: PD as Assessed by Cognitive Test Battery: Groton Maze Learning - Delayed Recall|Part 1: Evoked Stress Response as Assessed by Induced Stress|Part 2: Latency to Persistent Sleep (LPS) by 8-hour Overnight Polysomnography|Part 2: Total Time Spent in Deep Sleep (Duration of Slow Wave Sleep) - Stage 3 Sleep by 8-Hour Overnight Polysomnography|Part 2: Time in bed by 8-hour Overnight Polysomnography|Part 2: Cognitive Test Battery: Continuous Paired Associate Learning Task (CPAL)|Part 1 and 2: Maximum Observed Plasma Concentration (Cmax)|Part 1 and 2: Time to Reach Maximum Observed Plasma Concentration (Tmax)|Part 1 and 2: Area Under the Plasma Concentration-Time Curve from Time 0 to Time of the Last Quantifiable Concentrations (AUC[0-last])","The Effect of JNJ-55375515 on slow wave activity recorded by the electroencephalogram (EEG) will be evaluated. EEG recordings are made using gold electrodes, fixed at Midline Frontal Electrode (Fz), Midline Central Electrode (Cz), Midline Parietal Electrode (Pz) and Midline Occipital Electrode (Oz), with the same common ground electrode as for the eye movement registration (international 10/20 system). Per session eight consecutive blocks of eight seconds are recorded. For each lead, fast Fourier transform analysis will be performed to obtain the sum of amplitudes in the very low (0.5-2 Hertz|Heart rate variability (HRV) is the physiological phenomenon of variation in the time interval between heartbeats. It is measured by the variation in the beat-to-beat interval. HRV will be derived from Holter recordings. Holter recordings will start pre dose on Day 1 of each period in Part 1 and continue for 24 hours. Measurements will be made at rest (during 5 minutes) and HRV parameters will be derived from these 5-minute recordings and from the 24-hour recordings.|Saccadic eye movements will be recorded to measure saccadic reaction time (RT). The recording and analysis of saccadic eye movements is performed using a computer-based system for sampling and analysis of eye movements. In a typical test system, electrodes are applied on the forehead and beside the lateral canthi of both eyes of the participant for registration of the electro-oculographic signals. Head movements are restrained using a fixed head support. The target consists of a moving dot that is displayed on a computer screen. Fifteen saccades are recorded with inter-stimulus intervals varying randomly between 3 and 6 seconds. Average values of latency (reaction time) of all correct saccades will be assessed.|Saccadic eye movements will be recorded to measure saccadic peak velocity (SPV). The recording and analysis of saccadic eye movements is performed using a computer-based system for sampling and analysis of eye movements. In a typical test system, electrodes are applied on the forehead and beside the lateral canthi of both eyes of the participant for registration of the electro-oculographic signals. Head movements are restrained using a fixed head support. The target consists of a moving dot that is displayed on a computer screen. Fifteen saccades are recorded with inter-stimulus intervals varying randomly between 3 and 6 seconds. Average values of saccadic peak velocity of all correct saccades will be assessed.|The body sway meter allows measurement of body movements in a single plane, providing a measure of postural stability. Body sway may be measured with a pot string meter (Celesco) based on the Wright ataxiameter or platform. Participants will be instructed to wear a pair of comfortable, low-heeled shoes on each session. The total period of body-sway measurement will be 2 minutes.|The KSS is a patient reported assessment of drowsiness level at the time of scale administration. This scale is focused mainly on the propensity to fall asleep and has a high validity in assessing sleepiness. It consists of a 9-point Likert scale with response options from: 1=very alert, 3=alert, 5=neither alert nor sleepy, 7=sleepy (but not fighting sleep), 9=very sleepy (fighting sleep).|The Bond and Lader Visual Analogue Scale consists of sixteen 100 millimeter (mm) visual analog scales anchored by antonyms (example, Alert-Drowsy, Lethargic-Energetic, etc). Scores will be combined to form three mood factors: alertness, calmness, and contentedness.|To establish diurnal levels of cortisol levels, repeated serum samples will be obtained throughout the Day 1 of each period. The diurnal cortisol levels will be explored to further clarify the effect of the compound on the hypothalamic-pituitary-adrenal-axis.|In this motivational processing task, participants with depressive symptoms may show a lower response bias towards a reward compared to healthy participants. The PILT allows the objective assessment of participants propensity to modulate behavior as a function of reward.|The International Shopping List Test is a measure of Verbal Memory-Learning. The test measures total number of correct responses remembering the 16-word list on three consecutive learning trials. Higher score indicates better performance.|Groton Maze Learning Task is a measure of Executive Function and Spatial Learning. The test measures total number of errors made while locating and learning 28 step pathway hidden beneath a 10*10 grid on 5 consecutive trials during a single session. Lower score indicates better performance.|To evaluate social and emotional cognition, a series of tests will be used to quantify both the ability to empathize and understand the emotions of others, and the ability to interpret their thoughts and intentions. A classical test involves the presentation of facial expressions and is asked to choose which word best describes what the person in the image is thinking or trying.|Detection task is a measure of Psychomotor Function. The test measures speed of performance; mean of the log10 transformed reaction times for correct responses. Lower score indicates better performance.|Identification task is a measure of Attention. The test measures speed of performance; mean of the log10 transformed reaction times for correct responses. Lower score indicates better performance.|One back task is a measure of Working Memory. The test measures speed of performance; mean of the log10 transformed reaction times for correct responses. Lower score indicates better performance.|International shopping list test - Delayed Recall is a measure of Delayed Verbal Memory. The test measures total number of correct responses recalling the 16 words learned previously after a delay. Higher score indicates better performance.|Groton Maze Learning - Delayed recall is a measure of Delayed Spatial Memory. The test measures number of errors made while locating 28 step pathway hidden beneath a 10*10 grid after a delay. Lower score indicates better performance.|The induced stress test consists of a highly demanding computer task that is performed for 20 minutes.|LPS is the time in minutes from 'lights out' that marks the starting of total recording time to the first epoch scored as sleep.|Polysomnographic recordings will be used to determine the total time spent in deep sleep (duration of slow wave sleep) -stage 3 sleep by 8-hour overnight.|Polysomnographic recordings will be used to determine the time in bed by 8-hour overnight.|The Continuous Paired Associate Learning (CPAL) test will be used to assess whether JNJâ€‘55375515 will improve performance of complex cognitive tasks. CPAL assess Visual episodic memory (associate learning) cognitive domain. In this task, participants must learn a series of associations between a set of difficult to verbalize patterns (amoeba) and locations. In healthy adults, 14 pattern/location associations must be learned. In the presentation phase of the task the pattern appears at the location and the participant is required to acknowledge that they have seen the pattern by touching the location at which it appears. Patterns are presented in random order. In the learning phase of the task, participants must place each of the 14 patterns in their correct locations. They must do this in 10 rounds. Number of errors made in correctly placing each of the four patterns in their location four times. (Lower score = better performance).|Cmax is the maximum observed plasma concentration.|Tmax is defined as actual sampling time to reach maximum observed analyte concentration.|AUC(0-last) is area under the plasma concentration-time curve from time 0 to time of the last quantifiable concentrations.","Hz), delta- (2-4 Hz), theta (4-7.5 Hz), alpha- (7.5-13.5 Hz), beta- (13.5-35 Hz), and gamma-(35-48.9 Hz) frequency ranges. The total test will last approximately 2 minutes.|Pre-dose (Day 1) up to 24 hours post dose|Pre-dose, 1 h, 2h, and 4h post dose on Day 1|Pre-dose, 1h, 2h, and 4h post dose on Day 1|Baseline, 1h, 2h, and 4h post dose on Day 1|Part 1: Pre-dose, 1h, 3h, and 8h post dose on Day 1; Part 2: Pre-dose (Day 1) and 8h post dose (Day 2)|Part 1: Baseline, 0.5h, 1h, 2h, 3h, 4h, 5h 45minutes (m), 6h, 6h 05m, 6h 25m, 6h 30m, 6h 50m, 6h 55m, 7h 15m, 7h 35m, 8h, 12h and 24h post dose on Day 1; Part 2: Baseline, 0.5h, 1h, 2h (Day 1 or 2), 3h, 4h, 6h, 8h, 12h and 24h post dose on Day 2|Pre-dose, 3h, and 8h post dose on Day 1|6h 30m to 6h 50m post dose on Day 1|0 hour (Day 1) up to 8 Hour (Day 2)|-7 hour (Day 1), 17 hour (Day 2)|Part 1: Pre-dose, 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 72h, and 96h post dose; Part 2: Pre dose, 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 46h, 70h, and 94h post dose|Part 1: Pre-dose, 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 72h, and 96h post dose; Part 2: Pre-dose, 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 46h, 70h, and 94h post dose","JNJ.CT@sylogent.com","Study Contact","844-434-4210","Groningen, Netherlands, 9728 Nz",null,"Netherlands","Pra Health Sciences Onderzoekscentrum Groningen, Locatie Martini",{"$nulls":3},"Janssen Research & Development, LLC Clinical Trial","2018-07-31","2020-05-25T16:37:48.202","2020-05-26T17:10:42.972","NCT03405441"]
["5ecbf45cfeab101b15530912","NCT03405714","2018-02-14","UCB","UCBJF","Not yet recruiting","A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Intravenous Brivaracetam in Subjects >= 1 Month to < 16 Years of Age With Epilepsy","Brivaracetam","SV2A Modulator","No",null,"No",null,"Phase 2",1,50,"Anticipated","2018-02-01","2021-01-06",{"$nulls":5},"The purpose of the study is to evaluate the pharmacokinetics (PK), safety, and tolerability of brivaracetam (BRV) administered intravenously (iv) in subjects >= 1 month to < 16 years of age with epilepsy.",null,"A Multicenter, Open-Label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Intravenous Brivaracetam in Subjects >= 1 Month < 16 Years of Age With Epilepsy","EP0065","Epilepsy","Epilepsy","Central Nervous System Diseases","Central Nervous System","Experimental","Brivaracetam","Brivaracetam will be administered to various age-based cohorts. Cohort 1: Subjects >=12 to <16 years; Cohort 2: Subjects >=6 to <12 years; Cohort 3: Subjects >=2 to <6 years; Cohort 4: Subjects 1 month to <2 years. Enrollment will be sequential by descending age beginning with Cohort 1. For each cohort, the first half will receive a 15-minute iv infusion. The Data Monitoring Committee (DMC) will then review safety and, as available, PK data to make the following recommendations: the progression of the current cohort (up to 2-minute iv bolus infusion) and progression to initiate enrollment in the preceding cohort.","Drug","Brivaracetam","* Pharmaceutical form: Solution for iv injection\n * Route of administration: intravenous use\n * Concentration: 10 mg/ml","Briviact","Brivaracetam","\n\n * Male or female from >= 1 month to < 16 years of age. For subjects who are < 1 year from birth and who were preterm infants, the corrected gestational age should be used for this entry requirement\n * Weight >= 3 kg (6.6 lbs)\n * Diagnosis of epilepsy\n * Acceptable candidate for venipuncture and intravenous (iv) infusion\n * Treatment with >=1 anti epileptic drug (AED; including BRV) without a change of dose regimen for at least 7 days prior to Screening\n * No treatment with vagus nerve stimulation (VNS), OR the subject is being treated with VNS and the settings have been constant for >=7 days prior to Screening\n * For female subjects: not of childbearing potential, OR of childbearing potential and not sexually active/negative pregnancy test, OR of childbearing potential and sexually active/negative pregnancy test/uses medically acceptable contraceptive methods\n\n","\n\n * Subject has previously received iv Brivaracetam (BRV) in this study\n * Subject is being treated with BRV at a dose >5mg/kg/day (rounded) or >200mg/day for subjects with body weights >40kg\n * Subject requires or is likely to require a change in concomitant antiepileptic drug(s) (AED[s]), dose of concomitant AED(s), or formulation of AED(s) during the 7 days prior to the intravenous (iv) pharmacokinetic (PK) Period\n * Subject is likely, in the opinion of the Investigator, to require rescue medication during the Initiating Oral BRV (IOB) Treatment or iv PK Periods\n * Subject has experienced generalized convulsive status epilepticus in the 28 days prior to Screening or during the Screening Period",{"$nulls":4},"Actual","2018-01-23","Actual","Anticipated","2021-01-06","Anticipated","2018-02-01","2018-01-12","2018-01-12","2018-02-13","Yes","Epilepsy\nBrivaracetam\nBriviact\nOpen-label\npediatric\nintravenous","Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","1 Month","16 Years","All",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2016-002452-25","EudraCT Number","Incidence of adverse events throughout the study|Number of subject withdrawals due to AEs|Plasma concentration of brivaracetam (BRV)","An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.|Blood samples will be taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.","From Screening (Day -20 to -1) until last visit (up to day 68)|Blood samples will be collected <= 1 hour pre-initiation of intravenous (iv) BRV infusion and 15 min and 3 hours post-initiation of iv BRV infusion.",{"$nulls":3},"UCBCares@ucb.com","UCB Cares","+1844599 Ext. 2273",{"$nulls":7},"UCB Cares","2018-02-13","2020-05-25T16:37:48.953","2020-05-26T17:10:42.972","NCT03405714"]
["5ecbf45dfeab101b15530913","NCT03405714","2018-03-14","UCB","UCBJF","Not yet recruiting","A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Intravenous Brivaracetam in Subjects >= 1 Month to < 16 Years of Age With Epilepsy","Brivaracetam","SV2A Modulator","No",null,"No",null,"Phase 2",1,50,"Anticipated","2018-03-01","2020-02-01",{"$nulls":5},"The purpose of the study is to evaluate the pharmacokinetics (PK), safety, and tolerability of brivaracetam (BRV) administered intravenously (iv) in subjects >= 1 month to < 16 years of age with epilepsy.",null,"A Multicenter, Open-Label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Intravenous Brivaracetam in Subjects >= 1 Month < 16 Years of Age With Epilepsy","EP0065","Epilepsy","Epilepsy","Central Nervous System Diseases","Central Nervous System","Experimental","Brivaracetam","Brivaracetam will be administered to various age-based cohorts. Cohort 1: Subjects >=12 to <16 years; Cohort 2: Subjects >=6 to <12 years; Cohort 3: Subjects >=2 to <6 years; Cohort 4: Subjects 1 month to <2 years. Enrollment will be sequential by descending age beginning with Cohort 1. For each cohort, the first half will receive a 15-minute iv infusion. The Data Monitoring Committee (DMC) will then review safety and, as available, PK data to make the following recommendations: the progression of the current cohort (up to 2-minute iv bolus infusion) and progression to initiate enrollment in the preceding cohort.","Drug","Brivaracetam","* Pharmaceutical form: Solution for iv injection\n * Route of administration: intravenous use\n * Concentration: 10 mg/ml","Briviact","Brivaracetam","\n\n * Male or female from >= 1 month to < 16 years of age. For subjects who are < 1 year from birth and who were preterm infants, the corrected gestational age should be used for this entry requirement\n * Weight >= 3 kg (6.6 lbs)\n * Diagnosis of epilepsy\n * Acceptable candidate for venipuncture and intravenous (iv) infusion\n * Treatment with >=1 anti epileptic drug (AED; including BRV) without a change of dose regimen for at least 7 days prior to Screening\n * No treatment with vagus nerve stimulation (VNS), OR the subject is being treated with VNS and the settings have been constant for >=7 days prior to Screening\n * For female subjects: not of childbearing potential, OR of childbearing potential and not sexually active/negative pregnancy test, OR of childbearing potential and sexually active/negative pregnancy test/uses medically acceptable contraceptive methods\n\n","\n\n * Subject has previously received iv Brivaracetam (BRV) in this study\n * Subject is being treated with BRV at a dose >5mg/kg/day (rounded) or >200mg/day for subjects with body weights >40kg\n * Subject requires or is likely to require a change in concomitant antiepileptic drug(s) (AED[s]), dose of concomitant AED(s), or formulation of AED(s) during the 7 days prior to the intravenous (iv) pharmacokinetic (PK) Period\n * Subject is likely, in the opinion of the Investigator, to require rescue medication during the Initiating Oral BRV (IOB) Treatment or iv PK Periods\n * Subject has experienced generalized convulsive status epilepticus in the 28 days prior to Screening or during the Screening Period",{"$nulls":4},"Actual","2018-01-23","Actual","Anticipated","2020-02-01","Anticipated","2018-03-01","2018-01-12","2018-01-12","2018-03-13","Yes","Epilepsy\nBrivaracetam\nBriviact\nOpen-label\npediatric\nintravenous","Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","1 Month","16 Years","All",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2016-002452-25","EudraCT Number","Incidence of adverse events throughout the study|Number of subject withdrawals due to AEs|Plasma concentration of brivaracetam (BRV)","An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.|Blood samples will be taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.","From Screening (Day -20 to -1) until last visit (up to day 68)|Blood samples will be collected <= 1 hour pre-initiation of intravenous (iv) BRV infusion and 15 min and 3 hours post-initiation of iv BRV infusion.",{"$nulls":3},"UCBCares@ucb.com","UCB Cares","+1844599 Ext. 2273",{"$nulls":7},"UCB Cares","2018-03-13","2020-05-25T16:37:49.323","2020-05-26T17:10:42.972","NCT03405714"]
["5ecbf45d11702c1b1b916af3","NCT03405714","2018-06-20","UCB","UCBJF","Recruiting","A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Intravenous Brivaracetam in Subjects >= 1 Month to < 16 Years of Age With Epilepsy","Brivaracetam","SV2A Modulator","No",null,"No",null,"Phase 2",1,50,"Anticipated","2018-06-01","2020-07-01",{"$nulls":5},"The purpose of the study is to evaluate the pharmacokinetics (PK), safety, and tolerability of brivaracetam (BRV) administered intravenously (iv) in subjects >= 1 month to < 16 years of age with epilepsy.",null,"A Multicenter, Open-Label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Intravenous Brivaracetam in Subjects >= 1 Month < 16 Years of Age With Epilepsy","EP0065","Epilepsy","Epilepsy","Central Nervous System Diseases","Central Nervous System","Experimental","Brivaracetam","Brivaracetam will be administered to various age-based cohorts. Cohort 1: Subjects >=12 to <16 years; Cohort 2: Subjects >=6 to <12 years; Cohort 3: Subjects >=2 to <6 years; Cohort 4: Subjects 1 month to <2 years. Enrollment will be sequential by descending age beginning with Cohort 1. For each cohort, the first half will receive a 15-minute iv infusion. The Data Monitoring Committee (DMC) will then review safety and, as available, PK data to make the following recommendations: the progression of the current cohort (up to 2-minute iv bolus infusion) and progression to initiate enrollment in the preceding cohort.","Drug","Brivaracetam","* Pharmaceutical form: Solution for iv injection\n * Route of administration: intravenous use\n * Concentration: 10 mg/ml","Briviact","Brivaracetam","\n\n * Male or female from >= 1 month to < 16 years of age. For subjects who are < 1 year from birth and who were preterm infants, the corrected gestational age should be used for this entry requirement\n * Weight >= 3 kg (6.6 lbs)\n * Diagnosis of epilepsy\n * Acceptable candidate for venipuncture and intravenous (iv) infusion\n * Treatment with >=1 anti epileptic drug (AED; including BRV) without a change of dose regimen for at least 7 days prior to Screening\n * No treatment with vagus nerve stimulation (VNS), OR the subject is being treated with VNS and the settings have been constant for >=7 days prior to Screening\n * For female subjects: not of childbearing potential, OR of childbearing potential and not sexually active/negative pregnancy test, OR of childbearing potential and sexually active/negative pregnancy test/uses medically acceptable contraceptive methods\n\n","\n\n * Subject has previously received iv Brivaracetam (BRV) in this study\n * Subject is being treated with BRV at a dose >5mg/kg/day (rounded) or >200mg/day for subjects with body weights >40kg\n * Subject requires or is likely to require a change in concomitant antiepileptic drug(s) (AED[s]), dose of concomitant AED(s), or formulation of AED(s) during the 7 days prior to the intravenous (iv) pharmacokinetic (PK) Period\n * Subject is likely, in the opinion of the Investigator, to require rescue medication during the Initiating Oral BRV (IOB) Treatment or iv PK Periods\n * Subject has experienced generalized convulsive status epilepticus in the 28 days prior to Screening or during the Screening Period",{"$nulls":4},"Actual","2018-01-23","Actual","Anticipated","2020-07-01","Anticipated","2018-06-01","2018-01-12","2018-01-12","2018-06-19","Yes","Epilepsy\nBrivaracetam\nBriviact\nOpen-label\npediatric\nintravenous","Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","1 Month","16 Years","All",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2016-002452-25","EudraCT Number","Incidence of adverse events throughout the study|Number of subject withdrawals due to AEs|Plasma concentration of brivaracetam (BRV)","An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.|Blood samples will be taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.","From Screening (Day -20 to -1) until last visit (up to day 68)|Blood samples will be collected <= 1 hour pre-initiation of intravenous (iv) BRV infusion and 15 min and 3 hours post-initiation of iv BRV infusion.",{"$nulls":3},"UCBCares@ucb.com","UCB Cares","+1844599 Ext. 2273","Budapest, Hungary Ep0065 222Debrecen, Hungary Ep0065 232Miskolc, Hungary|Madrid, Spain Ep0065 248Sevilla, Spain|Gulf Breeze, Florida, United States, 32561 Ep0065 103Loxahatchee Groves, Florida, United States, 33470|Bethesda, Maryland, United States, 20817|New Brunswick, New Jersey, United States, 08901|San Antonio, Texas, United States, 78249","Florida|Maryland|New Jersey|Texas","Hungary|Spain|United States","Ep0065 224|Ep0065 306|Ep0065 108|Ep0065 225|Ep0065 233|Ep0065 221",{"$nulls":3},"UCB Cares","2018-06-19","2020-05-25T16:37:49.365","2020-05-26T17:10:42.972","NCT03405714"]
["5ecbf45de2561b1b11905dde","NCT03405714","2018-06-25","UCB","UCBJF","Recruiting","A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Intravenous Brivaracetam in Subjects >= 1 Month to < 16 Years of Age With Epilepsy","Brivaracetam","SV2A Modulator","No",null,"No",null,"Phase 2",1,50,"Anticipated","2018-06-01","2020-07-01",{"$nulls":5},"The purpose of the study is to evaluate the pharmacokinetics (PK), safety, and tolerability of brivaracetam (BRV) administered intravenously (iv) in subjects >= 1 month to < 16 years of age with epilepsy.",null,"A Multicenter, Open-Label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Intravenous Brivaracetam in Subjects >= 1 Month < 16 Years of Age With Epilepsy","EP0065","Epilepsy","Epilepsy","Central Nervous System Diseases","Central Nervous System","Experimental","Brivaracetam","Brivaracetam will be administered to various age-based cohorts. Cohort 1: Subjects >=12 to <16 years; Cohort 2: Subjects >=6 to <12 years; Cohort 3: Subjects >=2 to <6 years; Cohort 4: Subjects 1 month to <2 years. Enrollment will be sequential by descending age beginning with Cohort 1. For each cohort, the first half will receive a 15-minute iv infusion. The Data Monitoring Committee (DMC) will then review safety and, as available, PK data to make the following recommendations: the progression of the current cohort (up to 2-minute iv bolus infusion) and progression to initiate enrollment in the preceding cohort.","Drug","Brivaracetam","* Pharmaceutical form: Solution for iv injection\n * Route of administration: intravenous use\n * Concentration: 10 mg/ml","Briviact","Brivaracetam","\n\n * Male or female from >= 1 month to < 16 years of age. For subjects who are < 1 year from birth and who were preterm infants, the corrected gestational age should be used for this entry requirement\n * Weight >= 3 kg (6.6 lbs)\n * Diagnosis of epilepsy\n * Acceptable candidate for venipuncture and intravenous (iv) infusion\n * Treatment with >=1 anti epileptic drug (AED; including BRV) without a change of dose regimen for at least 7 days prior to Screening\n * No treatment with vagus nerve stimulation (VNS), OR the subject is being treated with VNS and the settings have been constant for >=7 days prior to Screening\n * For female subjects: not of childbearing potential, OR of childbearing potential and not sexually active/negative pregnancy test, OR of childbearing potential and sexually active/negative pregnancy test/uses medically acceptable contraceptive methods\n\n","\n\n * Subject has previously received iv Brivaracetam (BRV) in this study\n * Subject is being treated with BRV at a dose >5mg/kg/day (rounded) or >200mg/day for subjects with body weights >40kg\n * Subject requires or is likely to require a change in concomitant antiepileptic drug(s) (AED[s]), dose of concomitant AED(s), or formulation of AED(s) during the 7 days prior to the intravenous (iv) pharmacokinetic (PK) Period\n * Subject is likely, in the opinion of the Investigator, to require rescue medication during the Initiating Oral BRV (IOB) Treatment or iv PK Periods\n * Subject has experienced generalized convulsive status epilepticus in the 28 days prior to Screening or during the Screening Period",{"$nulls":4},"Actual","2018-01-23","Actual","Anticipated","2020-07-01","Anticipated","2018-06-01","2018-01-12","2018-01-12","2018-06-21","Yes","Epilepsy\nBrivaracetam\nBriviact\nOpen-label\npediatric\nintravenous","Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","1 Month","16 Years","All",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2016-002452-25","EudraCT Number","Incidence of adverse events throughout the study|Number of subject withdrawals due to AEs|Plasma concentration of brivaracetam (BRV)","An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.|Blood samples will be taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.","From Screening (Day -20 to -1) until last visit (up to day 68)|Blood samples will be collected <= 1 hour pre-initiation of intravenous (iv) BRV infusion and 15 min and 3 hours post-initiation of iv BRV infusion.",{"$nulls":3},"UCBCares@ucb.com","UCB Cares","+1844599 Ext. 2273","Balassagyarmat, Hungary Ep0065 224Budapest, Hungary Ep0065 222Debrecen, Hungary Ep0065 232Miskolc, Hungary|Madrid, Spain Ep0065 248Sevilla, Spain|Gulf Breeze, Florida, United States, 32561 Ep0065 103Loxahatchee Groves, Florida, United States, 33470|Bethesda, Maryland, United States, 20817|New Brunswick, New Jersey, United States, 08901|Akron, Ohio, United States, 44308|San Antonio, Texas, United States, 78249","Florida|Maryland|New Jersey|Ohio|Texas","Hungary|Spain|United States","Ep0065 228|Ep0065 306|Ep0065 108|Ep0065 225|Ep0065 233|Ep0065 102|Ep0065 221",{"$nulls":3},"UCB Cares","2018-06-21","2020-05-25T16:37:49.347","2020-05-26T17:10:42.972","NCT03405714"]
["5ecbf45e11702c1b1b916af4","NCT03405714","2018-07-20","UCB","UCBJF","Recruiting","A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Intravenous Brivaracetam in Subjects >= 1 Month to < 16 Years of Age With Epilepsy","Brivaracetam","SV2A Modulator","No",null,"No",null,"Phase 2",1,50,"Anticipated","2018-06-01","2020-07-01",{"$nulls":5},"The purpose of the study is to evaluate the pharmacokinetics (PK), safety, and tolerability of brivaracetam (BRV) administered intravenously (iv) in subjects >= 1 month to < 16 years of age with epilepsy.",null,"A Multicenter, Open-Label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Intravenous Brivaracetam in Subjects >= 1 Month < 16 Years of Age With Epilepsy","EP0065","Epilepsy","Epilepsy","Central Nervous System Diseases","Central Nervous System","Experimental","Brivaracetam","Brivaracetam will be administered to various age-based cohorts. Cohort 1: Subjects >=12 to <16 years; Cohort 2: Subjects >=6 to <12 years; Cohort 3: Subjects >=2 to <6 years; Cohort 4: Subjects 1 month to <2 years. Enrollment will be sequential by descending age beginning with Cohort 1. For each cohort, the first half will receive a 15-minute iv infusion. The Data Monitoring Committee (DMC) will then review safety and, as available, PK data to make the following recommendations: the progression of the current cohort (up to 2-minute iv bolus infusion) and progression to initiate enrollment in the preceding cohort.","Drug","Brivaracetam","* Pharmaceutical form: Solution for iv injection\n * Route of administration: intravenous use\n * Concentration: 10 mg/ml","Briviact","Brivaracetam","\n\n * Male or female from >= 1 month to < 16 years of age. For subjects who are < 1 year from birth and who were preterm infants, the corrected gestational age should be used for this entry requirement\n * Weight >= 3 kg (6.6 lbs)\n * Diagnosis of epilepsy\n * Acceptable candidate for venipuncture and intravenous (iv) infusion\n * Treatment with >=1 anti epileptic drug (AED; including BRV) without a change of dose regimen for at least 7 days prior to Screening\n * No treatment with vagus nerve stimulation (VNS), OR the subject is being treated with VNS and the settings have been constant for >=7 days prior to Screening\n * For female subjects: not of childbearing potential, OR of childbearing potential and not sexually active/negative pregnancy test, OR of childbearing potential and sexually active/negative pregnancy test/uses medically acceptable contraceptive methods\n\n","\n\n * Subject has previously received iv Brivaracetam (BRV) in this study\n * Subject is being treated with BRV at a dose >5mg/kg/day (rounded) or >200mg/day for subjects with body weights >40kg\n * Subject requires or is likely to require a change in concomitant antiepileptic drug(s) (AED[s]), dose of concomitant AED(s), or formulation of AED(s) during the 7 days prior to the intravenous (iv) pharmacokinetic (PK) Period\n * Subject is likely, in the opinion of the Investigator, to require rescue medication during the Initiating Oral BRV (IOB) Treatment or iv PK Periods\n * Subject has experienced generalized convulsive status epilepticus in the 28 days prior to Screening or during the Screening Period",{"$nulls":4},"Actual","2018-01-23","Actual","Anticipated","2020-07-01","Anticipated","2018-06-01","2018-01-12","2018-01-12","2018-07-19","Yes","Epilepsy\nBrivaracetam\nBriviact\nOpen-label\npediatric\nintravenous","Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","1 Month","16 Years","All",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2016-002452-25","EudraCT Number","Incidence of adverse events throughout the study|Number of subject withdrawals due to AEs|Plasma concentration of brivaracetam (BRV)","An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.|Blood samples will be taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.","From Screening (Day -20 to -1) until last visit (up to day 68)|Blood samples will be collected <= 1 hour pre-initiation of intravenous (iv) BRV infusion and 15 min and 3 hours post-initiation of iv BRV infusion.",{"$nulls":3},"UCBCares@ucb.com","UCB Cares","+1844599 Ext. 2273","Kork, Germany|Balassagyarmat, Hungary Ep0065 210Budapest, Hungary Ep0065 224Budapest, Hungary Ep0065 222Debrecen, Hungary Ep0065 232Miskolc, Hungary|Madrid, Spain Ep0065 248Sevilla, Spain|Gulf Breeze, Florida, United States, 32561 Ep0065 103Loxahatchee Groves, Florida, United States, 33470|Bethesda, Maryland, United States, 20817|New Brunswick, New Jersey, United States, 08901|Akron, Ohio, United States, 44308|San Antonio, Texas, United States, 78249","Florida|Maryland|New Jersey|Ohio|Texas","Germany|Hungary|Spain|United States","Ep0065 245|Ep0065 228|Ep0065 306|Ep0065 108|Ep0065 225|Ep0065 233|Ep0065 102|Ep0065 221",{"$nulls":3},"UCB Cares","2018-07-19","2020-05-25T16:37:50.029","2020-05-26T17:10:42.972","NCT03405714"]
["5ecbf45dfeab101b15530914","NCT03405714","2018-08-03","UCB","UCBJF","Recruiting","A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Intravenous Brivaracetam in Subjects >= 1 Month to < 16 Years of Age With Epilepsy","Brivaracetam","SV2A Modulator","No",null,"No",null,"Phase 2",1,50,"Anticipated","2018-06-01","2020-07-01",{"$nulls":5},"The purpose of the study is to evaluate the pharmacokinetics (PK), safety, and tolerability of brivaracetam (BRV) administered intravenously (iv) in subjects >= 1 month to < 16 years of age with epilepsy.",null,"A Multicenter, Open-Label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Intravenous Brivaracetam in Subjects >= 1 Month < 16 Years of Age With Epilepsy","EP0065","Epilepsy","Epilepsy","Central Nervous System Diseases","Central Nervous System","Experimental","Brivaracetam","Brivaracetam will be administered to various age-based cohorts. Cohort 1: Subjects >=12 to <16 years; Cohort 2: Subjects >=6 to <12 years; Cohort 3: Subjects >=2 to <6 years; Cohort 4: Subjects 1 month to <2 years. Enrollment will be sequential by descending age beginning with Cohort 1. For each cohort, the first half will receive a 15-minute iv infusion. The Data Monitoring Committee (DMC) will then review safety and, as available, PK data to make the following recommendations: the progression of the current cohort (up to 2-minute iv bolus infusion) and progression to initiate enrollment in the preceding cohort.","Drug","Brivaracetam","* Pharmaceutical form: Solution for iv injection\n * Route of administration: intravenous use\n * Concentration: 10 mg/ml","Briviact","Brivaracetam","\n\n * Male or female from >= 1 month to < 16 years of age. For subjects who are < 1 year from birth and who were preterm infants, the corrected gestational age should be used for this entry requirement\n * Weight >= 3 kg (6.6 lbs)\n * Diagnosis of epilepsy\n * Acceptable candidate for venipuncture and intravenous (iv) infusion\n * Treatment with >=1 anti epileptic drug (AED; including BRV) without a change of dose regimen for at least 7 days prior to Screening\n * No treatment with vagus nerve stimulation (VNS), OR the subject is being treated with VNS and the settings have been constant for >=7 days prior to Screening\n * For female subjects: not of childbearing potential, OR of childbearing potential and not sexually active/negative pregnancy test, OR of childbearing potential and sexually active/negative pregnancy test/uses medically acceptable contraceptive methods\n\n","\n\n * Subject has previously received iv Brivaracetam (BRV) in this study\n * Subject is being treated with BRV at a dose >5mg/kg/day (rounded) or >200mg/day for subjects with body weights >40kg\n * Subject requires or is likely to require a change in concomitant antiepileptic drug(s) (AED[s]), dose of concomitant AED(s), or formulation of AED(s) during the 7 days prior to the intravenous (iv) pharmacokinetic (PK) Period\n * Subject is likely, in the opinion of the Investigator, to require rescue medication during the Initiating Oral BRV (IOB) Treatment or iv PK Periods\n * Subject has experienced generalized convulsive status epilepticus in the 28 days prior to Screening or during the Screening Period",{"$nulls":4},"Actual","2018-01-23","Actual","Anticipated","2020-07-01","Anticipated","2018-06-01","2018-01-12","2018-01-12","2018-08-02","Yes","Epilepsy\nBrivaracetam\nBriviact\nOpen-label\npediatric\nintravenous","Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","1 Month","16 Years","All",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2016-002452-25","EudraCT Number","Incidence of adverse events throughout the study|Number of subject withdrawals due to AEs|Plasma concentration of brivaracetam (BRV)","An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.|Blood samples will be taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.","From Screening (Day -20 to -1) until last visit (up to day 68)|Blood samples will be collected <= 1 hour pre-initiation of intravenous (iv) BRV infusion and 15 min and 3 hours post-initiation of iv BRV infusion.",{"$nulls":3},"UCBCares@ucb.com","UCB Cares","+1844599 Ext. 2273","Kork, Germany|Balassagyarmat, Hungary Ep0065 210Budapest, Hungary Ep0065 224Budapest, Hungary Ep0065 222Debrecen, Hungary Ep0065 232Miskolc, Hungary|Parma, Italy|Madrid, Spain Ep0065 248Sevilla, Spain|Gulf Breeze, Florida, United States, 32561 Ep0065 103Loxahatchee Groves, Florida, United States, 33470|Bethesda, Maryland, United States, 20817|New Brunswick, New Jersey, United States, 08901|Akron, Ohio, United States, 44308|San Antonio, Texas, United States, 78249","Florida|Maryland|New Jersey|Ohio|Texas","Germany|Hungary|Italy|Spain|United States","Ep0065 245|Ep0065 228|Ep0065 213|Ep0065 306|Ep0065 108|Ep0065 225|Ep0065 233|Ep0065 102|Ep0065 221",{"$nulls":3},"UCB Cares","2018-08-02","2020-05-25T16:37:49.901","2020-05-26T17:10:42.972","NCT03405714"]
["5ecbf45efeab101b15530915","NCT03405714","2018-10-26","UCB","UCBJF","Recruiting","A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Intravenous Brivaracetam in Subjects >= 1 Month to < 16 Years of Age With Epilepsy","Brivaracetam","SV2A Modulator","No",null,"No",null,"Phase 2",1,50,"Anticipated","2018-06-01","2020-07-01",{"$nulls":5},"The purpose of the study is to evaluate the pharmacokinetics (PK), safety, and tolerability of brivaracetam (BRV) administered intravenously (iv) in subjects >= 1 month to < 16 years of age with epilepsy.",null,"A Multicenter, Open-Label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Intravenous Brivaracetam in Subjects >= 1 Month < 16 Years of Age With Epilepsy","EP0065","Epilepsy","Epilepsy","Central Nervous System Diseases","Central Nervous System","Experimental","Brivaracetam","Brivaracetam will be administered to various age-based cohorts. Cohort 1: Subjects >=12 to <16 years; Cohort 2: Subjects >=6 to <12 years; Cohort 3: Subjects >=2 to <6 years; Cohort 4: Subjects 1 month to <2 years. Enrollment will be sequential by descending age beginning with Cohort 1. For each cohort, the first half will receive a 15-minute iv infusion. The Data Monitoring Committee (DMC) will then review safety and, as available, PK data to make the following recommendations: the progression of the current cohort (up to 2-minute iv bolus infusion) and progression to initiate enrollment in the preceding cohort.","Drug","Brivaracetam","* Pharmaceutical form: Solution for iv injection\n * Route of administration: intravenous use\n * Concentration: 10 mg/ml","Briviact","Brivaracetam","\n\n * Male or female from >= 1 month to < 16 years of age. For subjects who are < 1 year from birth and who were preterm infants, the corrected gestational age should be used for this entry requirement\n * Weight >= 3 kg (6.6 lbs)\n * Diagnosis of epilepsy\n * Acceptable candidate for venipuncture and intravenous (iv) infusion\n * Treatment with >=1 anti epileptic drug (AED; including BRV) without a change of dose regimen for at least 7 days prior to Screening\n * No treatment with vagus nerve stimulation (VNS), OR the subject is being treated with VNS and the settings have been constant for >=7 days prior to Screening\n * For female subjects: not of childbearing potential, OR of childbearing potential and not sexually active/negative pregnancy test, OR of childbearing potential and sexually active/negative pregnancy test/uses medically acceptable contraceptive methods\n\n","\n\n * Subject has previously received iv Brivaracetam (BRV) in this study\n * Subject is being treated with BRV at a dose >5mg/kg/day (rounded) or >200mg/day for subjects with body weights >40kg\n * Subject requires or is likely to require a change in concomitant antiepileptic drug(s) (AED[s]), dose of concomitant AED(s), or formulation of AED(s) during the 7 days prior to the intravenous (iv) pharmacokinetic (PK) Period\n * Subject is likely, in the opinion of the Investigator, to require rescue medication during the Initiating Oral BRV (IOB) Treatment or iv PK Periods\n * Subject has experienced generalized convulsive status epilepticus in the 28 days prior to Screening or during the Screening Period",{"$nulls":4},"Actual","2018-01-23","Actual","Anticipated","2020-07-01","Anticipated","2018-10-01","2018-01-12","2018-01-12","2018-10-25","Yes","Epilepsy\nBrivaracetam\nBriviact\nOpen-label\npediatric\nintravenous","Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","1 Month","16 Years","All",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2016-002452-25","EudraCT Number","Incidence of adverse events throughout the study|Number of subject withdrawals due to AEs|Plasma concentration of brivaracetam (BRV)","An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.|Blood samples will be taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.","From Screening (Day -20 to -1) until last visit (up to day 68)|Blood samples will be collected <= 1 hour pre-initiation of intravenous (iv) BRV infusion and 15 min and 3 hours post-initiation of iv BRV infusion.",{"$nulls":3},"UCBCares@ucb.com","UCB Cares","+1844599 Ext. 2273","Hradec KrÃ¡lovÃ©, Czechia Ep0065 240Praha 4, Czechia Ep0065 231Praha 5, Czechia|Bielefeld, Germany Ep0065 245Kork, Germany|Balassagyarmat, Hungary Ep0065 210Budapest, Hungary Ep0065 224Budapest, Hungary Ep0065 247Budapest, Hungary Ep0065 222Debrecen, Hungary Ep0065 232Miskolc, Hungary|Florence, Italy Ep0065 213Parma, Italy Ep0065 230Roma, Italy|Madrid, Spain Ep0065 248Sevilla, Spain|Los Angeles, California, United States, 90027 Ep0065 244San Bernardino, California, United States, 92408|Gulf Breeze, Florida, United States, 32561 Ep0065 103Loxahatchee Groves, Florida, United States, 33470|Bethesda, Maryland, United States, 20817|New Brunswick, New Jersey, United States, 08901|Bronx, New York, United States, 10467|Durham, North Carolina, United States, 27710|Akron, Ohio, United States, 44308|San Antonio, Texas, United States, 78249","California|Florida|Maryland|New Jersey|New York|North Carolina|Ohio|Texas","Czechia|Germany|Hungary|Italy|Spain|United States","Ep0065 502|Ep0065 254|Ep0065 228|Ep0065 229|Ep0065 306|Ep0065 243|Ep0065 108|Ep0065 225|Ep0065 233|Ep0065 252|Ep0065 237|Ep0065 102|Ep0065 221",{"$nulls":3},"UCB Cares","2018-10-25","2020-05-25T16:37:50.303","2020-05-26T17:10:42.972","NCT03405714"]
["5ecbf45ee2561b1b11905de1","NCT03405714","2018-12-21","UCB","UCBJF","Recruiting","A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Intravenous Brivaracetam in Subjects >= 1 Month to < 16 Years of Age With Epilepsy","Brivaracetam","SV2A Modulator","No",null,"No",null,"Phase 2",1,50,"Anticipated","2018-06-01","2020-07-01",{"$nulls":5},"The purpose of the study is to evaluate the pharmacokinetics (PK), safety, and tolerability of brivaracetam (BRV) administered intravenously (iv) in subjects >= 1 month to < 16 years of age with epilepsy.",null,"A Multicenter, Open-Label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Intravenous Brivaracetam in Subjects >= 1 Month < 16 Years of Age With Epilepsy","EP0065","Epilepsy","Epilepsy","Central Nervous System Diseases","Central Nervous System","Experimental","Brivaracetam","Brivaracetam will be administered to various age-based cohorts. Cohort 1: Subjects >=12 to <16 years; Cohort 2: Subjects >=6 to <12 years; Cohort 3: Subjects >=2 to <6 years; Cohort 4: Subjects 1 month to <2 years. Enrollment will be sequential by descending age beginning with Cohort 1. For each cohort, the first half will receive a 15-minute iv infusion. The Data Monitoring Committee (DMC) will then review safety and, as available, PK data to make the following recommendations: the progression of the current cohort (up to 2-minute iv bolus infusion) and progression to initiate enrollment in the preceding cohort.","Drug","Brivaracetam","* Pharmaceutical form: Solution for iv injection\n * Route of administration: intravenous use\n * Concentration: 10 mg/ml","Briviact","Brivaracetam","\n\n * Male or female from >= 1 month to < 16 years of age. For subjects who are < 1 year from birth and who were preterm infants, the corrected gestational age should be used for this entry requirement\n * Weight >= 3 kg (6.6 lbs)\n * Diagnosis of epilepsy\n * Acceptable candidate for venipuncture and intravenous (iv) infusion\n * Treatment with >=1 anti epileptic drug (AED; including BRV) without a change of dose regimen for at least 7 days prior to Screening\n * No treatment with vagus nerve stimulation (VNS), OR the subject is being treated with VNS and the settings have been constant for >=7 days prior to Screening\n * For female subjects: not of childbearing potential, OR of childbearing potential and not sexually active/negative pregnancy test, OR of childbearing potential and sexually active/negative pregnancy test/uses medically acceptable contraceptive methods\n\n","\n\n * Subject has previously received iv Brivaracetam (BRV) in this study\n * Subject is being treated with BRV at a dose >5mg/kg/day (rounded) or >200mg/day for subjects with body weights >40kg\n * Subject requires or is likely to require a change in concomitant antiepileptic drug(s) (AED[s]), dose of concomitant AED(s), or formulation of AED(s) during the 7 days prior to the intravenous (iv) pharmacokinetic (PK) Period\n * Subject is likely, in the opinion of the Investigator, to require rescue medication during the Initiating Oral BRV (IOB) Treatment or iv PK Periods\n * Subject has experienced generalized convulsive status epilepticus in the 28 days prior to Screening or during the Screening Period",{"$nulls":4},"Actual","2018-01-23","Actual","Anticipated","2020-07-01","Anticipated","2018-12-01","2018-01-12","2018-01-12","2018-12-19","Yes","Epilepsy\nBrivaracetam\nBriviact\nOpen-label\npediatric\nintravenous","Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","1 Month","16 Years","All",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2016-002452-25","EudraCT Number","Incidence of adverse events throughout the study|Number of subject withdrawals due to AEs|Plasma concentration of brivaracetam (BRV)","An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.|Blood samples will be taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.","From Screening (Day -20 to -1) until last visit (up to day 68)|Blood samples will be collected <= 1 hour pre-initiation of intravenous (iv) BRV infusion and 15 min and 3 hours post-initiation of iv BRV infusion.",{"$nulls":3},"UCBCares@ucb.com","UCB Cares","+1844599 Ext. 2273","Hradec KrÃ¡lovÃ©, Czechia Ep0065 240Praha 4, Czechia Ep0065 231Praha 5, Czechia|Berlin, Germany Ep0065 254Bielefeld, Germany Ep0065 245Kork, Germany|Balassagyarmat, Hungary Ep0065 210Budapest, Hungary Ep0065 224Budapest, Hungary Ep0065 247Budapest, Hungary Ep0065 222Debrecen, Hungary Ep0065 232Miskolc, Hungary|Catania, Italy Ep0065 229Florence, Italy Ep0065 213Parma, Italy Ep0065 239Pavia, Italy Ep0065 230Roma, Italy|Madrid, Spain Ep0065 248Sevilla, Spain|Los Angeles, California, United States, 90027 Ep0065 244San Bernardino, California, United States, 92408|Gulf Breeze, Florida, United States, 32561 Ep0065 103Loxahatchee Groves, Florida, United States, 33470|Bethesda, Maryland, United States, 20817|New Brunswick, New Jersey, United States, 08901|Bronx, New York, United States, 10467|Durham, North Carolina, United States, 27710|Akron, Ohio, United States, 44308|San Antonio, Texas, United States, 78249","California|Florida|Maryland|New Jersey|New York|North Carolina|Ohio|Texas","Czechia|Germany|Hungary|Italy|Spain|United States","Ep0065 502|Ep0065 242|Ep0065 228|Ep0065 219|Ep0065 306|Ep0065 243|Ep0065 108|Ep0065 225|Ep0065 233|Ep0065 252|Ep0065 237|Ep0065 102|Ep0065 221",{"$nulls":3},"UCB Cares","2018-12-19","2020-05-25T16:37:50.506","2020-05-26T17:10:42.972","NCT03405714"]
["5ecbf45e11702c1b1b916af5","NCT03405714","2019-09-17","UCB","UCBJF","Recruiting","A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Intravenous Brivaracetam in Subjects >= 1 Month to < 16 Years of Age With Epilepsy","Brivaracetam","SV2A Modulator","No",null,"No",null,"Phase 2",1,50,"Anticipated","2018-06-01","2020-04-01",{"$nulls":5},"The purpose of the study is to evaluate the pharmacokinetics (PK), safety, and tolerability of brivaracetam (BRV) administered intravenously (iv) in subjects >= 1 month to < 16 years of age with epilepsy.",null,"A Multicenter, Open-Label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Intravenous Brivaracetam in Subjects >= 1 Month < 16 Years of Age With Epilepsy","EP0065","Epilepsy","Epilepsy","Central Nervous System Diseases","Central Nervous System","Experimental","Brivaracetam","Brivaracetam will be administered to various age-based cohorts. Cohort 1: Subjects >=12 to <16 years; Cohort 2: Subjects >=6 to <12 years; Cohort 3: Subjects >=2 to <6 years; Cohort 4: Subjects 1 month to <2 years. Enrollment will be sequential by descending age beginning with Cohort 1. For each cohort, the first half will receive a 15-minute iv infusion. The Data Monitoring Committee (DMC) will then review safety and, as available, PK data to make the following recommendations: the progression of the current cohort (up to 2-minute iv bolus infusion) and progression to initiate enrollment in the preceding cohort.","Drug","Brivaracetam","* Pharmaceutical form: Solution for iv injection\n * Route of administration: intravenous use\n * Concentration: 10 mg/ml","Briviact","Brivaracetam","\n\n * Male or female from >= 1 month to < 16 years of age. For subjects who are < 1 year from birth and who were preterm infants, the corrected gestational age should be used for this entry requirement\n * Weight >= 3 kg (6.6 lbs)\n * Diagnosis of epilepsy\n * Acceptable candidate for venipuncture and intravenous (iv) infusion\n * Treatment with >=1 anti epileptic drug (AED; including BRV) without a change of dose regimen for at least 7 days prior to Screening\n * No treatment with vagus nerve stimulation (VNS), OR the subject is being treated with VNS and the settings have been constant for >=7 days prior to Screening\n * For female subjects: not of childbearing potential, OR of childbearing potential and not sexually active/negative pregnancy test, OR of childbearing potential and sexually active/negative pregnancy test/uses medically acceptable contraceptive methods\n\n","\n\n * Subject has previously received iv Brivaracetam (BRV) in this study\n * Subject is being treated with BRV at a dose >5mg/kg/day (rounded) or >200mg/day for subjects with body weights >40kg\n * Subject requires or is likely to require a change in concomitant antiepileptic drug(s) (AED[s]), dose of concomitant AED(s), or formulation of AED(s) during the 7 days prior to the intravenous (iv) pharmacokinetic (PK) Period\n * Subject is likely, in the opinion of the Investigator, to require rescue medication during the Initiating Oral BRV (IOB) Treatment or iv PK Periods\n * Subject has experienced generalized convulsive status epilepticus in the 28 days prior to Screening or during the Screening Period",{"$nulls":4},"Actual","2018-01-23","Actual","Anticipated","2020-04-01","Anticipated","2019-09-01","2018-01-12","2018-01-12","2019-09-16","Yes","Epilepsy\nBrivaracetam\nBriviact\nOpen-label\npediatric\nintravenous","Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","1 Month","16 Years","All",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2016-002452-25","EudraCT Number","Incidence of adverse events throughout the study|Number of subject withdrawals due to AEs|Plasma concentration of brivaracetam (BRV)","An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.|Blood samples will be taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.","From Screening (Day -20 to -1) until last visit (up to day 68)|Blood samples will be collected <= 1 hour pre-initiation of intravenous (iv) BRV infusion and 15 min and 3 hours post-initiation of iv BRV infusion.",{"$nulls":3},"UCBCares@ucb.com","UCB Cares","+1844599 Ext. 2273","Hradec KrÃ¡lovÃ©, Czechia Ep0065 504Ostrava-Poruba, Czechia Ep0065 240Praha 4, Czechia Ep0065 231Praha 5, Czechia|Berlin, Germany Ep0065 254Bielefeld, Germany Ep0065 245Kork, Germany Ep0065 250Vogtareuth, Germany|Balassagyarmat, Hungary Ep0065 210Budapest, Hungary Ep0065 224Budapest, Hungary Ep0065 247Budapest, Hungary Ep0065 222Debrecen, Hungary Ep0065 232[Active, Not Recruiting]Miskolc, Hungary|Catania, Italy Ep0065 229Florence, Italy Ep0065 264Milan, Italy Ep0065 213Parma, Italy Ep0065 238Pavia, Italy Ep0065 239Pavia, Italy Ep0065 230Roma, Italy|Aguas Calientes, Mexico Ep0065 255Guadalajara, Mexico Ep0065 603Guadalajara, Mexico Ep0065 234, Mexico, Mexico Ep0065 601, Mexico, Mexico|Madrid, Spain Ep0065 248Sevilla, Spain|Los Angeles, California, United States, 90027 Ep0065 244San Bernardino, California, United States, 92408|Gulf Breeze, Florida, United States, 32561 Ep0065 103Loxahatchee Groves, Florida, United States, 33470|Bethesda, Maryland, United States, 20817|New Brunswick, New Jersey, United States, 08901|Bronx, New York, United States, 10467|Durham, North Carolina, United States, 27710|Akron, Ohio, United States, 44308|Memphis, Tennessee, United States, 38105|San Antonio, Texas, United States, 78249","California|Florida|Maryland|New Jersey|New York|North Carolina|Ohio|Tennessee|Texas","Czechia|Germany|Hungary|Italy|Mexico|Spain|United States","Ep0065 502|Ep0065 242|Ep0065 228|Ep0065 219|Ep0065 223|Ep0065 306|Ep0065 243|Ep0065 108|Ep0065 225|Ep0065 233|Ep0065 252|Ep0065 237|Ep0065 102|Ep0065 227|Ep0065 221",{"$nulls":3},"UCB Cares","2019-09-16","2020-05-25T16:37:50.373","2020-05-26T17:10:42.972","NCT03405714"]
["5ecbf45ffe30261b1a0482e7","NCT03405714","2020-02-28","UCB","UCBJF","Recruiting","A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Intravenous Brivaracetam in Subjects >= 1 Month to < 16 Years of Age With Epilepsy","Brivaracetam","SV2A Modulator","No",null,"No",null,"Phase 2",1,50,"Anticipated","2018-06-01","2020-04-01",{"$nulls":5},"The purpose of the study is to evaluate the pharmacokinetics (PK), safety, and tolerability of brivaracetam (BRV) administered intravenously (iv) in subjects >= 1 month to < 16 years of age with epilepsy.",null,"A Multicenter, Open-Label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Intravenous Brivaracetam in Subjects >= 1 Month < 16 Years of Age With Epilepsy","EP0065","Epilepsy","Epilepsy","Central Nervous System Diseases","Central Nervous System","Experimental","Brivaracetam","Brivaracetam will be administered to various age-based cohorts. Cohort 1: Subjects >=12 to <16 years; Cohort 2: Subjects >=6 to <12 years; Cohort 3: Subjects >=2 to <6 years; Cohort 4: Subjects 1 month to <2 years. Enrollment will be sequential by descending age beginning with Cohort 1. For each cohort, the first half will receive a 15-minute iv infusion. The Data Monitoring Committee (DMC) will then review safety and, as available, PK data to make the following recommendations: the progression of the current cohort (up to 2-minute iv bolus infusion) and progression to initiate enrollment in the preceding cohort.","Drug","Brivaracetam","* Pharmaceutical form: Solution for iv injection\n * Route of administration: intravenous use\n * Concentration: 10 mg/ml","Briviact","Brivaracetam","\n\n * Male or female from >= 1 month to < 16 years of age. For subjects who are < 1 year from birth and who were preterm infants, the corrected gestational age should be used for this entry requirement\n * Weight >= 3 kg (6.6 lbs)\n * Diagnosis of epilepsy\n * Acceptable candidate for venipuncture and intravenous (iv) infusion\n * Treatment with >=1 anti epileptic drug (AED; including BRV) without a change of dose regimen for at least 7 days prior to Screening\n * No treatment with vagus nerve stimulation (VNS), OR the subject is being treated with VNS and the settings have been constant for >=7 days prior to Screening\n * For female subjects: not of childbearing potential, OR of childbearing potential and not sexually active/negative pregnancy test, OR of childbearing potential and sexually active/negative pregnancy test/uses medically acceptable contraceptive methods\n\n","\n\n * Subject has previously received iv Brivaracetam (BRV) in this study\n * Subject is being treated with BRV at a dose >5mg/kg/day (rounded) or >200mg/day for subjects with body weights >40kg\n * Subject requires or is likely to require a change in concomitant antiepileptic drug(s) (AED[s]), dose of concomitant AED(s), or formulation of AED(s) during the 7 days prior to the intravenous (iv) pharmacokinetic (PK) Period\n * Subject is likely, in the opinion of the Investigator, to require rescue medication during the Initiating Oral BRV (IOB) Treatment or iv PK Periods\n * Subject has experienced generalized convulsive status epilepticus in the 28 days prior to Screening or during the Screening Period",{"$nulls":4},"Actual","2018-01-23","Actual","Anticipated","2020-04-01","Anticipated","2020-02-01","2018-01-12","2018-01-12","2020-02-27","Yes","Epilepsy\nBrivaracetam\nBriviact\nOpen-label\npediatric\nintravenous","Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","1 Month","16 Years","All",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2016-002452-25","EudraCT Number","Incidence of adverse events throughout the study|Number of subject withdrawals due to AEs|Plasma concentration of brivaracetam (BRV)","An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.|Blood samples will be taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.","From Screening (Day -20 to -1) until last visit (up to day 68)|Blood samples will be collected <= 1 hour pre-initiation of intravenous (iv) BRV infusion and 15 min and 3 hours post-initiation of iv BRV infusion.",{"$nulls":3},"UCBCares@ucb.com","UCB Cares","+1844599 Ext. 2273","Hradec KrÃ¡lovÃ©, Czechia Ep0065 504Ostrava-Poruba, Czechia Ep0065 240Praha 4, Czechia Ep0065 231Praha 5, Czechia|Berlin, Germany Ep0065 254Bielefeld, Germany Ep0065 245Kork, Germany Ep0065 250Vogtareuth, Germany|Balassagyarmat, Hungary Ep0065 210Budapest, Hungary Ep0065 224Budapest, Hungary Ep0065 247Budapest, Hungary Ep0065 222Debrecen, Hungary Ep0065 232[Active, Not Recruiting]Miskolc, Hungary|Catania, Italy Ep0065 229Florence, Italy Ep0065 246Milan, Italy Ep0065 264Milan, Italy Ep0065 213Parma, Italy Ep0065 238Pavia, Italy Ep0065 239Pavia, Italy Ep0065 230Roma, Italy|Aguas Calientes, Mexico Ep0065 255Guadalajara, Mexico Ep0065 603Guadalajara, Mexico Ep0065 234, Mexico, Mexico Ep0065 601, Mexico, Mexico|Madrid, Spain Ep0065 248Sevilla, Spain|Los Angeles, California, United States, 90027 Ep0065 244San Bernardino, California, United States, 92408|Gulf Breeze, Florida, United States, 32561 Ep0065 103Loxahatchee Groves, Florida, United States, 33470|Bethesda, Maryland, United States, 20817|New Brunswick, New Jersey, United States, 08901|Bronx, New York, United States, 10467|Durham, North Carolina, United States, 27710|Akron, Ohio, United States, 44308|Memphis, Tennessee, United States, 38105|San Antonio, Texas, United States, 78249","California|Florida|Maryland|New Jersey|New York|North Carolina|Ohio|Tennessee|Texas","Czechia|Germany|Hungary|Italy|Mexico|Spain|United States","Ep0065 502|Ep0065 242|Ep0065 228|Ep0065 219|Ep0065 223|Ep0065 306|Ep0065 243|Ep0065 108|Ep0065 225|Ep0065 233|Ep0065 252|Ep0065 237|Ep0065 102|Ep0065 227|Ep0065 221",{"$nulls":3},"UCB Cares","2020-02-27","2020-05-25T16:37:51.263","2020-05-26T17:10:42.972","NCT03405714"]
["5ecbf45ffeab101b15530917","NCT03405818","2018-01-23","Pfizer","PFE","Completed","An Evaluation of the Safety and Pharmacokinetics of Tavaborole Topical Solution for the Treatment of Fungal Disease of the Toenail in Children and Adolescents","Tavaborole","Protein Synthesis Inhibitor|t-RNA synthetase Inhibitor","No",null,"No",null,"Phase 4",1,55,"Actual","2015-10-22","2017-07-27",{"$nulls":5},"This was an open-label study to evaluate the safety and pharmacokinetics of tavaborole 5% topical solution in treating distal subungual onychomycosis (a fungal infection) of the toenail in children and adolescents (ages 6 to 16 years).\n\nFollowing confirmation of eligibility, including laboratory evidence of a fungal organism in the toenail, tavaborole topical solution was applied once daily to all affected toenails for a 48-week treatment period.\n\nClinical assessment of the extent of infection and safety assessments were performed periodically throughout the 48-week treatment period, and again at 52 weeks (4 weeks after stopping the treatment).\n\nA subgroup of enrolled subjects applied the topical solution to all 10 toenails and a small area of surrounding skin during the first 28 days. These subjects had blood samples analyzed to evaluate the pharmacokinetics (how the drug moves in the body) of tavaborole topical solution in children and adolescents.","This was an open-label study to evaluate the safety, tolerability, and pharmacokinetics of tavaborole 5% topical solution in treating distal subungual onychomycosis (DSO) of the toenail in pediatric subjects aged 6 to 16 years and 11 months. An eligible subject had a target great toenail (TGT) with at least 20% involvement, with a positive potassium hydroxide (KOH) wet mount and positive fungal culture for T. rubrum or T. mentagrophytes.\n\nEligible subjects applied tavaborole 5% topical solution, once daily to all affected toenails (the TGT as well as all other toenails having the clinical characteristics of onychomycosis) throughout the 48 week treatment period.\n\nSubjects were evaluated at Screening, Baseline (Day 1), and at Weeks 2, 4, 8, 16, 24, 32, 40, 48, and 52. Each evaluation included a clinical assessment of the AEs and local tolerability evaluation.\n\nAdditional procedures were performed as follows:\n\n * Mycology sampling at Screening, Week 24, and Week 52/early termination (ET);\n * Clinical disease severity of the TGT at Screening, Week 24, and Week 52/ET;\n * Safety laboratory testing at Baseline, Week 24, and Week 52/ET;\n\nIn this study, there was a PK subgroup of evaluable subjects aged 12 to 16 years and 11 months studied under maximal use conditions. Subjects in this maximal use subgroup applied the study drug on all 10 toenails, including up to 2 mm of the surrounding skin, for 28 days. On Day 15, a predose PK sample was collected to assess steady state trough level. On Day 29, the study drug application was done at the study site, and PK samples were collected prior to dosing, as well as 4, 6, 8, and 24 hours postdose on Days 29 to 30.","An Open-label Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of Kerydin (Registered) (Tavaborole) Topical Solution, 5% In The Treatment Of Onychomycosis Of The Toenail In Pediatric Subjects Ages 6 To 16 Years And 11 Months","TAV-ONYC-401","Onychomycosis\nTinea Unguium","Onychomycosis|Tinea","Infection","Infectious Disease","Experimental","Tavaborole 5% Topical Solution","All study participants apply study drug","Drug","Tavaborole 5% Topical Solution","topical solution for application to toenails","Kerydin","Tavaborole 5% Topical Solution","\n\n * males or females, ages >/= 6 years and </= 16 years and 11 months\n * clinical diagnosis of distal subungual onychomycosis affecting at least 20% of one of the great toenails (target nail); and with positive KOH and positive culture for T. rubrum or T. mentagrophytes from either great toenail\n\n","\n\n * the target toenail has proximal subungual onychomycosis, onychomycosis involving the nail lunula, superficial white onychomycosis, dermatophytoma, exclusively lateral disease, or yellow or brown spikes, or has co-infection with certain fungi or molds\n * anatomic abnormalities of the toes or toenail\n * current or past history of chronic moccasin-type tinea pedis\n * current or past history of psoriasis or lichen planus\n * history of significant chronic fungal disease (other than onychomycosis)\n * diabetes\n * immunodeficiency",{"$nulls":4},"Actual","2018-01-23","Actual","Actual","2017-07-27","Actual","2018-01-01","2018-01-03","2018-01-12","2018-01-12",null,"Fungal infection of the nail","Interventional","Treatment","Parallel Assignment","None (Open Label)","N/A","72 Months","203 Months","All",null,"No",{"$nulls":23},"C3371003","Alias Study Number","Number of Participants With Local Tolerability Reactions by Severity|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)|Change From Baseline in Hematology Parameters (Leukocytes: Basophils, Eosinophils, Hematocrit, Lymphocytes, Monocytes and Neutrophils) at Week 24|Change From Baseline in Hematology Parameters (Leukocytes: Basophils, Eosinophils, Hematocrit, Lymphocytes, Monocytes and Neutrophils) at Week 52|Change From Baseline in Hematology Parameter (Hematocrit) at Week 24|Change From Baseline in Hematology Parameter (Hematocrit) at Week 52|Change From Baseline in Hematology Parameter (Erythrocytes) at Week 24|Change From Baseline in Hematology Parameter (Erythrocytes) at Week 52|Change From Baseline in Hematology Parameters (Hemoglobin) at Week 24|Change From Baseline in Hematology Parameters (Hemoglobin) at Week 52|Change From Baseline in Hematology Parameters (Leukocytes and Platelets) at Week 24|Change From Baseline in Hematology Parameters (Leukocytes and Platelets) at Week 52|Change From Baseline in Chemistry Parameters (Alanine Aminotransferase, Alkaline Phosphatase and Aspartate Aminotransferase) at Week 24|Change From Baseline in Chemistry Parameters (Alanine Aminotransferase, Alkaline Phosphatase and Aspartate Aminotransferase) at Week 52|Change From Baseline in Chemistry Parameters (Albumin and Protein) at Week 24|Change From Baseline in Chemistry Parameters (Albumin and Protein) at Week 52|Change From Baseline in Chemistry Parameters (Bilirubin, Creatinine, Glucose [Non-fasting] and Urea Nitrogen) at Week 24|Change From Baseline in Chemistry Parameters (Bilirubin, Creatinine, Glucose [Non-fasting] and Urea Nitrogen) at Week 52|Change From Baseline in Chemistry Parameters (Potassium and Sodium) at Week 24|Change From Baseline in Chemistry Parameters (Potassium and Sodium) at Week 52|Change From Baseline in Vital Sign (Blood Pressure) at Week 24|Change From Baseline in Vital Sign (Blood Pressure) at Week 52|Change From Baseline in Vital Sign (Pulse Rate) at Week 24|Change From Baseline in Vital Sign (Pulse Rate) at Week 52|Change From Baseline in Vital Sign (Respiratory Rate) at Week 24|Change From Baseline in Vital Sign (Respiratory Rate) at Week 52|Percentage of Participants With Complete Cure of Target Great Toenail (TGT) at Week 52|Number of Participants With Adverse Events (AEs) By Severity","52 weeks|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. AEs included both serious and non-serious AEs.|Week 24|Week 52|defined as the number of pulsations noted in a peripheral artery per minute after participant rested supine for 5 minutes|Respiratory rate was defined as the number of inspirations per minute.|Complete cure was defined as completely clear nail, negative fungal culture and negative potassium hydroxide (KOH) wet mount.|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs were classified as mild, moderate and severe based on severity assessment by investigator and defined as: Mild = symptoms barely noticeable to the participant or does not make the participant uncomfortable; moderate = symptoms of a sufficient severity to make the participant uncomfortable; severe = symptoms of a sufficient severity to cause the participant severe discomfort.","Baseline up to 28 days after last dose of study drug (up to Week 52)|Week 24|Week 52","Maximum Observed Plasma Concentration (Cmax) of Tavaborole|Time to Maximum Observed Plasma Concentration (Tmax) of Tavaborole|Area Under the Plasma Concentration-Time Curve From Hour Zero to Hour 24 (AUC24) of Tavaborole|Area Under the Plasma Concentration-Time Curve Extrapolated to Infinity (AUCinf) of Tavaborole|Elimination Rate Constant of Tavaborole|Elimination Half-Life of Tavaborole|Percentage of Participants With Almost Complete Cure of Target Great Toenail (TGT) at Week 24 and 52|Percentage of Participants With Clinical Efficacy of Target Great Toenail (TGT) at Week 24 and 52|Percentage of Participants With Mycological Cure of Target Great Toenail (TGT) at Week 24 and 52|Percentage of Participants With Negative Fungal Culture of the Target Great Toenail (TGT) at Weeks 24 and 52","Pre-dose, 4, 6, 8, 24 hours post-dose on Day 29|AUC24 was defined as the area under the plasma concentration-time curve from hour 0 to hour 24. AUC24 was calculated using the linear trapezoidal rule|Elimination rate constant was defined as the rate at which a drug was removed from the body.|Elimination half-life (t1/2) was defined as the time required for the body to eliminate half of the drug than its original concentration.|Almost complete cure was defined as almost clear nail and negative mycology (negative mycology was defined as negative fungal culture and negative KOH wet mount).|Clinical efficacy target great toenail (TGT) was defined as completely clear nail or almost clear nail.|Mycological cure was defined as negative mycology of the TGT. Negative mycology was defined as negative fungal culture and negative potassium hydroxide (KOH) wet mount. Participants with only one result for either fungal culture or KOH were excluded from this analysis.|Week 24, 52","Pre-dose, 4, 6, 8, 24 hours post-dose on Day 29|Week 24, 52",{"$nulls":3},"West|Madera, California, United States, 93637 Stanford University School Of MedicinePalo Alto, California, United States, 94304 United States, District Of Columbia Medstar Health Research Institute - Medstar Georgetown University HospitalWashington, District Of Columbia, United States, 20016|South Miami, Florida, United States, 33143|Brooklyn, New York, United States, 11203 Skin Specialty DermatologyNew York, New York, United States, 10155|Gresham, Oregon, United States, 97030 Oregon Dermatology & Research CenterPortland, Oregon, United States, 97210|Houston, Texas, United States, 77055 Texas Dermatology And Laser SpecialistsSan Antonio, Texas, United States, 78218|Burke, Virginia, United States, 22015","California|Florida|New York|Oregon|Texas|Virginia","Jordan|United States","Valley Dermatology Center|Madera Family Medical Group|Doctors Research Network|University Hospital, Suny Downstate Medical Center|Cyn3Rgy Research|West Houston Clinical Research Services Llc|Pi Coor Clinical Research, Llc",{"$nulls":3},"Pfizer CT.gov Call Center","2018-01-12","2020-05-25T16:37:51.260","2020-05-26T17:10:42.972","NCT03405818"]
["5ecbf461feab101b1553091a","NCT03406000","2018-01-24","Sanofi","SNY","Recruiting","Phase 4 Study to Evaluate Treatment Optimization With Once-daily Insulin Glargine 300 U/mL (TOP1)","Insulin glargine","INSR Agonist","No",null,"No",null,"Phase 4",1,123,"Anticipated","2018-01-22","2019-01-01",{"$nulls":5},"Primary Objective:\n\nTo evaluate the efficacy of switching treatment from twice-daily basal insulin to once-daily insulin glargine (U300) as part of basal bolus regime in terms of glycated hemoglobin improvement (reduction by at least 0.3%), in uncontrolled type 1 diabetes mellitus patients.\n\nSecondary Objectives:\n\n * To evaluate other efficacy parameters in terms of glycemic control as well as safety including hypoglycemia events, weight changes, and adverse events.\n * To evaluate the effect of insulin glargine (U300) on diabetes treatment satisfaction and fear of hypoglycemia as well as patient's satisfaction regarding the number of daily injections.","The estimated average study duration is 29 weeks, including run-in period of 4 weeks; treatment period of 24 weeks, and follow-up period of 1 week.","A 28-week, Prospective, Single-arm, Phase 4 Study to Evaluate Treatment Optimization With Once-daily Insulin Glargine 300 U/mL in Combination With Prandial Rapid-acting Insulin Analogue in Patients With Type 1 Diabetes Previously Uncontrolled on Twice-daily Basal Insulin as Part of Basal-bolus Therapy","GLARGL08200","Type I Diabetes Mellitus","Type 2 Diabetes|Type 1 Diabetes|Prediabetes","Metabolic Diseases","Nutritional Disorders","Experimental","Insulin glargine (U300)","Self-administered subcutaneously once daily in the morning, at the same time.The initial dose for patients switching from insulin glargine is 80% of the total daily dose of basal insulin agent that was discontinued. Thereafter, insulin glargine (U300) will follow a titration algorithm for dose adjustment.","Drug","INSULIN GLARGINE (U300)","Pharmaceutical form: Solution for Injection\n\nRoute of administration: Subcutaneous injection","Toujeo, HOE901","Insulin glargine (U300)"," * Male or Female.\n * Age â‰¥ 18 years.\n * With Type 1 diabetes mellitus.\n * Being treated twice-daily with any basal insulin in combination with prandial rapid-acting insulin analogue for at least one year.\n * Have an glycated hemoglobin (HbA1c) measurement of 7.5% - 10.0% at study entry.\n * Patients who have signed an Informed Consent Form.\n\n"," * Type 2 diabetes mellitus.\n * Known hypoglycemia unawareness\n * Repeated episodes of severe hypoglycemia or diabetes ketoacidosis within the last 12 months.\n * End-stage renal failure or being on hemodialysis.\n * Any clinically significant abnormality identified on physical examination, laboratory tests, or vital signs at the time of screening or baseline, or any major systemic disease resulting in short life expectancy that in the opinion of the Investigator would restrict or limit the patient's successful participation for the duration of the study.\n * Known hypersensitivity / intolerance to insulin glargine or any of its excipients.\n * Patients treated with glucagon like peptide agonists.\n * Use of systemic glucocorticoids (excluding topical application or inhaled forms) for one week or more within 90 days prior to the time of screening.\n * Pregnant or lactating women.\n * Women of childbearing potential with no effective contraceptive method.\n * Participation in another clinical trial.\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial. ",{"$nulls":4},"Actual","2018-01-23","Actual","Anticipated","2019-01-01","Anticipated","2018-01-01","2018-01-15","2018-01-19","2018-01-23","No",null,"Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No","Yes\nQualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://www.clinicalstudydatarequest.com/",{"$nulls":3},"No","No",{"$nulls":4},"No",{"$nulls":12},"U1111-1186-2485","UTN","Mean change in HbA1c","Mean change in glycated hemoglobin (HbA1c) from baseline to Week 24 (%)","From baseline to Week 24","Mean change in HbA1c|Mean change in fasting plasma glucose (FPG)|Mean change in fasting SMBG|Mean change in 8-point SMBG|Proportion of patients achieving HbA1c target of <7.0%|Proportion of patients achieving HbA1c target of <7.0% without hypoglycemia event|Proportion of patients achieving HbA1c improvement of at least 0.3% without nocturnal hypoglycemia|Proportion of patients with any improvement in HbA1c|Proportion of patients with no deterioration in HbA1c|Adverse events (AEs)|Mean change in body weight|Mean change in daily insulin doses|Number of patients experiencing hypoglycemia|Proportion of patients experiencing hypoglycemia|Number of hypoglycemic events per patient-year","Mean HbA1c change from baseline to Week 12|Mean change in FPG from baseline to Week 12 and Week 24|Mean change in fasting self-monitored blood glucose (SMBG) from baseline to Week 12 and Week 24|Mean change in 8-point SMBG from baseline to Week 12 and Week 24|Proportion of patients achieving HbA1c target of <7.0% at Week 12 and Week 24|Proportion of patients achieving HbA1c target of <7.0% without hypoglycemia event during the last 4 weeks of treatment|Proportion of patients achieving HbA1c improvement from baseline to week 24 of at least 0.3% without nocturnal hypoglycemia (documented <70 mg/dL) and/or severe hypoglycemia (between 00.00 and 05:59 am SMBG) during the last 4 weeks of treatment|Proportion of patients with any improvement in HbA1c from baseline to week 24 and decrease in occurrence of nocturnal hypoglycemia (nocturnal defined as time between 00.00 and 05:59 am) evaluated from baseline to Week 24|Proportion of patients with no deterioration in HbA1c from baseline to week 24 and decrease in occurrence of nocturnal hypoglycemia|Proportion of patients with no deterioration in HbA1c from baseline to week 24 and no increase in occurrence of nocturnal hypoglycemia|Number of adverse events and serious adverse events|Mean change in body weight from baseline to Weeks 12 and 24|Insulin glargine (U300) dose: Mean change in daily insulin doses (basal, prandial, total) from baseline to Week 24|Up to 28 weeks","From baseline to Week 12|From baseline to Week 12 and Week 24|At Weeks 12 and 24|From baseline to Week 24|Up to 28 weeks","Contact-Us@sanofi.com","For site information, send an email with site number to",null,"Fortaleza, Brazil Investigational Site Number 076006SÃ£o JosÃ© Dos Campos, Brazil, 12243-280 Investigational Site Number 076001SÃ£o Paulo, Brazil",null,"Brazil","Investigational Site Number 076005",{"$nulls":3},"Clinical Sciences & Operations","2018-01-23","2020-05-25T16:37:53.604","2020-05-26T17:10:42.972","NCT03406000"]
["5ecbf462fe30261b1a0482eb","NCT03406000","2018-03-27","Sanofi","SNY","Recruiting","Phase 4 Study to Evaluate Treatment Optimization With Once-daily Insulin Glargine 300 U/mL (TOP1)","Insulin glargine","INSR Agonist","No",null,"No",null,"Phase 4",1,123,"Anticipated","2018-01-22","2019-01-01",{"$nulls":5},"Primary Objective:\n\nTo evaluate the efficacy of switching treatment from twice-daily basal insulin to once-daily insulin glargine (U300) as part of basal bolus regime in terms of glycated hemoglobin improvement (reduction by at least 0.3%), in uncontrolled type 1 diabetes mellitus patients.\n\nSecondary Objectives:\n\n * To evaluate other efficacy parameters in terms of glycemic control as well as safety including hypoglycemia events, weight changes, and adverse events.\n * To evaluate the effect of insulin glargine (U300) on diabetes treatment satisfaction and fear of hypoglycemia as well as patient's satisfaction regarding the number of daily injections.","The estimated average study duration is 29 weeks, including run-in period of 4 weeks; treatment period of 24 weeks, and follow-up period of 1 week.","A 28-week, Prospective, Single-arm, Phase 4 Study to Evaluate Treatment Optimization With Once-daily Insulin Glargine 300 U/mL in Combination With Prandial Rapid-acting Insulin Analogue in Patients With Type 1 Diabetes Previously Uncontrolled on Twice-daily Basal Insulin as Part of Basal-bolus Therapy","GLARGL08200","Type I Diabetes Mellitus","Type 2 Diabetes|Type 1 Diabetes|Prediabetes","Metabolic Diseases","Nutritional Disorders","Experimental","Insulin glargine (U300)","Self-administered subcutaneously once daily in the morning, at the same time.The initial dose for patients switching from insulin glargine is 80% of the total daily dose of basal insulin agent that was discontinued. Thereafter, insulin glargine (U300) will follow a titration algorithm for dose adjustment.","Drug","INSULIN GLARGINE (U300)","Pharmaceutical form: Solution for Injection\n\nRoute of administration: Subcutaneous injection","Toujeo, HOE901","Insulin glargine (U300)"," * Male or Female.\n * Age â‰¥ 18 years.\n * With Type 1 diabetes mellitus.\n * Being treated twice-daily with any basal insulin in combination with prandial rapid-acting insulin analogue for at least one year.\n * Have an glycated hemoglobin (HbA1c) measurement of 7.5% - 10.0% at study entry.\n * Patients who have signed an Informed Consent Form.\n\n"," * Type 2 diabetes mellitus.\n * Known hypoglycemia unawareness\n * Repeated episodes of severe hypoglycemia or diabetes ketoacidosis within the last 12 months.\n * End-stage renal failure or being on hemodialysis.\n * Any clinically significant abnormality identified on physical examination, laboratory tests, or vital signs at the time of screening or baseline, or any major systemic disease resulting in short life expectancy that in the opinion of the Investigator would restrict or limit the patient's successful participation for the duration of the study.\n * Known hypersensitivity / intolerance to insulin glargine or any of its excipients.\n * Patients treated with glucagon like peptide agonists.\n * Use of systemic glucocorticoids (excluding topical application or inhaled forms) for one week or more within 90 days prior to the time of screening.\n * Pregnant or lactating women.\n * Women of childbearing potential with no effective contraceptive method.\n * Participation in another clinical trial.\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial. ",{"$nulls":4},"Actual","2018-01-23","Actual","Anticipated","2019-01-01","Anticipated","2018-03-01","2018-01-15","2018-01-19","2018-03-26","No",null,"Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No","Yes\nQualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://www.clinicalstudydatarequest.com/",{"$nulls":3},"No","No",{"$nulls":4},"No",{"$nulls":12},"U1111-1186-2485","UTN","Mean change in HbA1c","Mean change in glycated hemoglobin (HbA1c) from baseline to Week 24 (%)","From baseline to Week 24","Mean change in HbA1c|Mean change in fasting plasma glucose (FPG)|Mean change in fasting SMBG|Mean change in 8-point SMBG|Proportion of patients achieving HbA1c target of <7.0%|Proportion of patients achieving HbA1c target of <7.0% without hypoglycemia event|Proportion of patients achieving HbA1c improvement of at least 0.3% without nocturnal hypoglycemia|Proportion of patients with any improvement in HbA1c|Proportion of patients with no deterioration in HbA1c|Adverse events (AEs)|Mean change in body weight|Mean change in daily insulin doses|Number of patients experiencing hypoglycemia|Proportion of patients experiencing hypoglycemia|Number of hypoglycemic events per patient-year","Mean HbA1c change from baseline to Week 12|Mean change in FPG from baseline to Week 12 and Week 24|Mean change in fasting self-monitored blood glucose (SMBG) from baseline to Week 12 and Week 24|Mean change in 8-point SMBG from baseline to Week 12 and Week 24|Proportion of patients achieving HbA1c target of <7.0% at Week 12 and Week 24|Proportion of patients achieving HbA1c target of <7.0% without hypoglycemia event during the last 4 weeks of treatment|Proportion of patients achieving HbA1c improvement from baseline to week 24 of at least 0.3% without nocturnal hypoglycemia (documented <70 mg/dL) and/or severe hypoglycemia (between 00.00 and 05:59 am SMBG) during the last 4 weeks of treatment|Proportion of patients with any improvement in HbA1c from baseline to week 24 and decrease in occurrence of nocturnal hypoglycemia (nocturnal defined as time between 00.00 and 05:59 am) evaluated from baseline to Week 24|Proportion of patients with no deterioration in HbA1c from baseline to week 24 and decrease in occurrence of nocturnal hypoglycemia|Proportion of patients with no deterioration in HbA1c from baseline to week 24 and no increase in occurrence of nocturnal hypoglycemia|Number of adverse events and serious adverse events|Mean change in body weight from baseline to Weeks 12 and 24|Insulin glargine (U300) dose: Mean change in daily insulin doses (basal, prandial, total) from baseline to Week 24|Up to 28 weeks","From baseline to Week 12|From baseline to Week 12 and Week 24|At Weeks 12 and 24|From baseline to Week 24|Up to 28 weeks","Contact-Us@sanofi.com","Email recommended (Toll free number for US & Canada)","800-633-1610 Ext. 1 then #","Fortaleza, Brazil Investigational Site Number 076006SÃ£o JosÃ© Dos Campos, Brazil, 12243-280 Investigational Site Number 076001SÃ£o Paulo, Brazil",null,"Brazil","Investigational Site Number 076005",{"$nulls":3},"Clinical Sciences & Operations","2018-03-26","2020-05-25T16:37:54.201","2020-05-26T17:10:42.972","NCT03406000"]
["5ecbf462e2561b1b11905de6","NCT03406000","2018-07-10","Sanofi","SNY","Recruiting","Phase 4 Study to Evaluate Treatment Optimization With Once-daily Insulin Glargine 300 U/mL (TOP1)","Insulin glargine","INSR Agonist","No",null,"No",null,"Phase 4",1,123,"Anticipated","2018-01-22","2019-01-01",{"$nulls":5},"Primary Objective:\n\nTo evaluate the efficacy of switching treatment from twice-daily basal insulin to once-daily insulin glargine (U300) as part of basal bolus regime in terms of glycated hemoglobin improvement (reduction by at least 0.3%), in uncontrolled type 1 diabetes mellitus patients.\n\nSecondary Objectives:\n\n * To evaluate other efficacy parameters in terms of glycemic control as well as safety including hypoglycemia events, weight changes, and adverse events.\n * To evaluate the effect of insulin glargine (U300) on diabetes treatment satisfaction and fear of hypoglycemia as well as patient's satisfaction regarding the number of daily injections.","The estimated average study duration is 29 weeks, including run-in period of 4 weeks; treatment period of 24 weeks, and follow-up period of 1 week.","A 28-week, Prospective, Single-arm, Phase 4 Study to Evaluate Treatment Optimization With Once-daily Insulin Glargine 300 U/mL in Combination With Prandial Rapid-acting Insulin Analogue in Patients With Type 1 Diabetes Previously Uncontrolled on Twice-daily Basal Insulin as Part of Basal-bolus Therapy","GLARGL08200","Type I Diabetes Mellitus","Type 2 Diabetes|Type 1 Diabetes|Prediabetes","Metabolic Diseases","Nutritional Disorders","Experimental","Insulin glargine (U300)","Self-administered subcutaneously once daily in the morning, at the same time.The initial dose for patients switching from insulin glargine is 80% of the total daily dose of basal insulin agent that was discontinued. Thereafter, insulin glargine (U300) will follow a titration algorithm for dose adjustment.","Drug","INSULIN GLARGINE (U300)","Pharmaceutical form: Solution for Injection\n\nRoute of administration: Subcutaneous injection","Toujeo, HOE901","Insulin glargine (U300)"," * Male or Female.\n * Age â‰¥ 18 years.\n * With Type 1 diabetes mellitus.\n * Being treated twice-daily with any basal insulin in combination with prandial rapid-acting insulin analogue for at least one year.\n * Have an glycated hemoglobin (HbA1c) measurement of 7.5% - 10.0% at study entry.\n * Patients who have signed an Informed Consent Form.\n\n"," * Type 2 diabetes mellitus.\n * Known hypoglycemia unawareness\n * Repeated episodes of severe hypoglycemia or diabetes ketoacidosis within the last 12 months.\n * End-stage renal failure or being on hemodialysis.\n * Any clinically significant abnormality identified on physical examination, laboratory tests, or vital signs at the time of screening or baseline, or any major systemic disease resulting in short life expectancy that in the opinion of the Investigator would restrict or limit the patient's successful participation for the duration of the study.\n * Known hypersensitivity / intolerance to insulin glargine or any of its excipients.\n * Patients treated with glucagon like peptide agonists.\n * Use of systemic glucocorticoids (excluding topical application or inhaled forms) for one week or more within 90 days prior to the time of screening.\n * Pregnant or lactating women.\n * Women of childbearing potential with no effective contraceptive method.\n * Participation in another clinical trial.\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial. ",{"$nulls":4},"Actual","2018-01-23","Actual","Anticipated","2019-01-01","Anticipated","2018-03-01","2018-01-15","2018-01-19","2018-07-09","No",null,"Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No","Yes\nQualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://www.clinicalstudydatarequest.com/",{"$nulls":3},"No","No",{"$nulls":4},"No",{"$nulls":12},"U1111-1186-2485","UTN","Mean change in HbA1c","Mean change in glycated hemoglobin (HbA1c) from baseline to Week 24 (%)","From baseline to Week 24","Mean change in HbA1c|Mean change in fasting plasma glucose (FPG)|Mean change in fasting SMBG|Mean change in 8-point SMBG|Proportion of patients achieving HbA1c target of <7.0%|Proportion of patients achieving HbA1c target of <7.0% without hypoglycemia event|Proportion of patients achieving HbA1c improvement of at least 0.3% without nocturnal hypoglycemia|Proportion of patients with any improvement in HbA1c|Proportion of patients with no deterioration in HbA1c|Adverse events (AEs)|Mean change in body weight|Mean change in daily insulin doses|Number of patients experiencing hypoglycemia|Proportion of patients experiencing hypoglycemia|Number of hypoglycemic events per patient-year","Mean HbA1c change from baseline to Week 12|Mean change in FPG from baseline to Week 12 and Week 24|Mean change in fasting self-monitored blood glucose (SMBG) from baseline to Week 12 and Week 24|Mean change in 8-point SMBG from baseline to Week 12 and Week 24|Proportion of patients achieving HbA1c target of <7.0% at Week 12 and Week 24|Proportion of patients achieving HbA1c target of <7.0% without hypoglycemia event during the last 4 weeks of treatment|Proportion of patients achieving HbA1c improvement from baseline to week 24 of at least 0.3% without nocturnal hypoglycemia (documented <70 mg/dL) and/or severe hypoglycemia (between 00.00 and 05:59 am SMBG) during the last 4 weeks of treatment|Proportion of patients with any improvement in HbA1c from baseline to week 24 and decrease in occurrence of nocturnal hypoglycemia (nocturnal defined as time between 00.00 and 05:59 am) evaluated from baseline to Week 24|Proportion of patients with no deterioration in HbA1c from baseline to week 24 and decrease in occurrence of nocturnal hypoglycemia|Proportion of patients with no deterioration in HbA1c from baseline to week 24 and no increase in occurrence of nocturnal hypoglycemia|Number of adverse events and serious adverse events|Mean change in body weight from baseline to Weeks 12 and 24|Insulin glargine (U300) dose: Mean change in daily insulin doses (basal, prandial, total) from baseline to Week 24|Up to 28 weeks","From baseline to Week 12|From baseline to Week 12 and Week 24|At Weeks 12 and 24|From baseline to Week 24|Up to 28 weeks","Contact-Us@sanofi.com","Trial Transparency email recommended (Toll free number for US & Canada)","800-633-1610 Ext. 1 then #","Fortaleza, Brazil Investigational Site Number 076006SÃ£o JosÃ© Dos Campos, Brazil, 12243-280 Investigational Site Number 076001SÃ£o Paulo, Brazil",null,"Brazil","Investigational Site Number 076005",{"$nulls":3},"Clinical Sciences & Operations","2018-07-09","2020-05-25T16:37:54.014","2020-05-26T17:10:42.972","NCT03406000"]
["5ecbf462feab101b1553091b","NCT03406000","2019-02-12","Sanofi","SNY","Completed","Phase 4 Study to Evaluate Treatment Optimization With Once-daily Insulin Glargine 300 U/mL (TOP1)","Insulin glargine","INSR Agonist","No",null,"No",null,"Phase 4",1,170,"Actual","2018-01-22","2019-02-04",{"$nulls":5},"Primary Objective:\n\nTo evaluate the efficacy of switching treatment from twice-daily basal insulin to once-daily insulin glargine (U300) as part of basal bolus regime in terms of glycated hemoglobin improvement (reduction by at least 0.3%), in uncontrolled type 1 diabetes mellitus patients.\n\nSecondary Objectives:\n\n * To evaluate other efficacy parameters in terms of glycemic control as well as safety including hypoglycemia events, weight changes, and adverse events.\n * To evaluate the effect of insulin glargine (U300) on diabetes treatment satisfaction and fear of hypoglycemia as well as patient's satisfaction regarding the number of daily injections.","The estimated average study duration is 29 weeks, including run-in period of 4 weeks; treatment period of 24 weeks, and follow-up period of 1 week.","A 28-week, Prospective, Single-arm, Phase 4 Study to Evaluate Treatment Optimization With Once-daily Insulin Glargine 300 U/mL in Combination With Prandial Rapid-acting Insulin Analogue in Patients With Type 1 Diabetes Previously Uncontrolled on Twice-daily Basal Insulin as Part of Basal-bolus Therapy","GLARGL08200","Type I Diabetes Mellitus","Type 2 Diabetes|Type 1 Diabetes|Prediabetes","Metabolic Diseases","Nutritional Disorders","Experimental","Insulin glargine (U300)","Self-administered subcutaneously once daily in the morning, at the same time.The initial dose for patients switching from insulin glargine is 80% of the total daily dose of basal insulin agent that was discontinued. Thereafter, insulin glargine (U300) will follow a titration algorithm for dose adjustment.","Drug","INSULIN GLARGINE (U300)","Pharmaceutical form: Solution for Injection\n\nRoute of administration: Subcutaneous injection","Toujeo, HOE901","Insulin glargine (U300)"," * Male or Female.\n * Age â‰¥ 18 years.\n * With Type 1 diabetes mellitus.\n * Being treated twice-daily with any basal insulin in combination with prandial rapid-acting insulin analogue for at least one year.\n * Have an glycated hemoglobin (HbA1c) measurement of 7.5% - 10.0% at study entry.\n * Patients who have signed an Informed Consent Form.\n\n"," * Type 2 diabetes mellitus.\n * Known hypoglycemia unawareness\n * Repeated episodes of severe hypoglycemia or diabetes ketoacidosis within the last 12 months.\n * End-stage renal failure or being on hemodialysis.\n * Any clinically significant abnormality identified on physical examination, laboratory tests, or vital signs at the time of screening or baseline, or any major systemic disease resulting in short life expectancy that in the opinion of the Investigator would restrict or limit the patient's successful participation for the duration of the study.\n * Known hypersensitivity / intolerance to insulin glargine or any of its excipients.\n * Patients treated with glucagon like peptide agonists.\n * Use of systemic glucocorticoids (excluding topical application or inhaled forms) for one week or more within 90 days prior to the time of screening.\n * Pregnant or lactating women.\n * Women of childbearing potential with no effective contraceptive method.\n * Participation in another clinical trial.\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial. ",{"$nulls":4},"Actual","2018-01-23","Actual","Actual","2019-02-04","Actual","2019-02-01","2018-01-15","2018-01-19","2019-02-11","No",null,"Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No","Yes\nQualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://www.clinicalstudydatarequest.com/",{"$nulls":3},"No","No",{"$nulls":4},"No",{"$nulls":12},"U1111-1186-2485","UTN","Mean change in HbA1c","Mean change in glycated hemoglobin (HbA1c) from baseline to Week 24 (%)","From baseline to Week 24","Mean change in HbA1c|Mean change in fasting plasma glucose (FPG)|Mean change in fasting SMBG|Mean change in 8-point SMBG|Proportion of patients achieving HbA1c target of <7.0%|Proportion of patients achieving HbA1c target of <7.0% without hypoglycemia event|Proportion of patients achieving HbA1c improvement of at least 0.3% without nocturnal hypoglycemia|Proportion of patients with any improvement in HbA1c|Proportion of patients with no deterioration in HbA1c|Adverse events (AEs)|Mean change in body weight|Mean change in daily insulin doses|Number of patients experiencing hypoglycemia|Proportion of patients experiencing hypoglycemia|Number of hypoglycemic events per patient-year","Mean HbA1c change from baseline to Week 12|Mean change in FPG from baseline to Week 12 and Week 24|Mean change in fasting self-monitored blood glucose (SMBG) from baseline to Week 12 and Week 24|Mean change in 8-point SMBG from baseline to Week 12 and Week 24|Proportion of patients achieving HbA1c target of <7.0% at Week 12 and Week 24|Proportion of patients achieving HbA1c target of <7.0% without hypoglycemia event during the last 4 weeks of treatment|Proportion of patients achieving HbA1c improvement from baseline to week 24 of at least 0.3% without nocturnal hypoglycemia (documented <70 mg/dL) and/or severe hypoglycemia (between 00.00 and 05:59 am SMBG) during the last 4 weeks of treatment|Proportion of patients with any improvement in HbA1c from baseline to week 24 and decrease in occurrence of nocturnal hypoglycemia (nocturnal defined as time between 00.00 and 05:59 am) evaluated from baseline to Week 24|Proportion of patients with no deterioration in HbA1c from baseline to week 24 and decrease in occurrence of nocturnal hypoglycemia|Proportion of patients with no deterioration in HbA1c from baseline to week 24 and no increase in occurrence of nocturnal hypoglycemia|Number of adverse events and serious adverse events|Mean change in body weight from baseline to Weeks 12 and 24|Insulin glargine (U300) dose: Mean change in daily insulin doses (basal, prandial, total) from baseline to Week 24|Up to 28 weeks","From baseline to Week 12|From baseline to Week 12 and Week 24|At Weeks 12 and 24|From baseline to Week 24|Up to 28 weeks",{"$nulls":3},"Campinas, Brazil, 13092-132 Investigational Site Number 076016Curitiba, Brazil, 80030-110 Investigational Site Number 076007Curitiba, Brazil, 80810-140 Investigational Site Number 076005Fortaleza, Brazil Investigational Site Number 076002GoiÃ¢nia, Brazil, 74175-100 Investigational Site Number 076004Porto Alegre, Brazil, 91350-250 Investigational Site Number 076011RibeirÃ£o Preto, Brazil, 14049900 Investigational Site Number 076006SÃ£o JosÃ© Dos Campos, Brazil, 12243-280 Investigational Site Number 076015SÃ£o Paulo, Brazil, 04022-001 Investigational Site Number 076012SÃ£o Paulo, Brazil, 05403-000 Investigational Site Number 076001SÃ£o Paulo, Brazil",null,"Brazil","Investigational Site Number 076013",{"$nulls":3},"Clinical Sciences & Operations","2019-02-11","2020-05-25T16:37:54.338","2020-05-26T17:10:42.972","NCT03406000"]
["5ecbf463e2561b1b11905de8","NCT03406156","2018-06-07","AbbVie","ABBV","Not yet recruiting","A Study in Previously Untreated Chronic Lymphocytic Leukemia (CLL) Subjects, Excluding Those With the 17p Deletion, to Evaluate Debulking Regimens Prior to Initiating Venetoclax Combination Therapy","Obinutuzumab|Bendamustine|Venetoclax","CD20 Antagonist|BCL2 Inhibitor","No",null,"No",null,"Phase 3",1,100,"Anticipated","2018-06-25","2022-04-03","Complete Remission Rate","Complete Remission Rate",{"$nulls":3},"A study in previously untreated Chronic Lymphocytic Leukemia to evaluate alternate administration strategies for induction therapy (debulking) with obinutuzumab or obinutuzumab/bendamustine prior to combination therapy with obinutuzumab and venetoclax,",null,"A Phase 3b Study in Previously Untreated Chronic Lymphocytic Leukemia (CLL) Subjects, Excluding Those With the 17p Deletion, to Evaluate Debulking Regimens Prior to Initiating Venetoclax Combination Therapy","M16-788","Chronic Lymphocytic Leukemia (CLL)","Leukemia|Chronic Leukemia|Lymphoid Leukemia|Chronic Lymphoid Leukemia","Oncology Hematological","Oncology","Experimental","Obinutuzumab +/- bendamustine then obinutuzumab + venetoclax",null,"Drug","Obinutuzumab|Bendamustine|Venetoclax","intravenous|tablet","Gazyva|Treanda|Venclexta | ABT-199\n | GDC-0199","Obinutuzumab +/- bendamustine then obinutuzumab + venetoclax","\n\n * Adequate hematology, kidney and liver function as described in the protocol.\n * Diagnosis of previously untreated chronic lymphocytic leukemia (CLL) according to 2008 Modified International Workshop on Chronic Lymphocytic Leukemia National Cancer Institute-sponsored Working Group (IWCLL NCI-WG) criteria.\n * Eastern Cooperative Oncology Group (ECOG) performance score of 0 - 1.\n * CLL requires treatment according to the IWCLL criteria.\n * Medium tumor burden (any lymph node [LN] 5 to < 10 cm OR absolute lymphocyte count [ALC] >= 25 Ã— 10^9/L) OR High tumor burden (any LN >= 10 cm OR ALC >= 25 Ã— 10^9/L and LN >= 5 cm).\n\n","\n\n * Presence of 17p deletion at Screening.\n * Richter's syndrome (transformation of CLL to aggressive non-Hodgkin's lymphoma or Hodgkin's lymphoma).\n * Prolymphocytic leukemia.",{"$nulls":4},"Actual","2018-01-23","Actual","Anticipated","2024-06-12","Anticipated","2018-06-01","2018-01-16","2018-01-16","2018-06-06","Yes","Cancer\nChronic Lymphocytic Leukemia\n17p Deletion\ndebulking\nobinutuzumab\nbendamustine\ntumor lysis syndrome\nvenetoclax","Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","18 Years","99 Years","All",null,"No","Undecided",null,"URL: http://www.rxabbvie.com/ [http://www.rxabbvie.com/] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: Related Info",null,"Yes","No",{"$nulls":4},"No",{"$nulls":14},"Percent of Participants Achieving Low Tumor Burden Status with induction of Obinutuzumab or Obinutuzumab plus Bendamustine (Debulking Period)|Complete Remission Rate (CR) and Complete Remission with Incomplete Marrow Recovery (CRi)","Low tumor burden is defined by peripheral lymphocyte counts of < 25,000 and all lymph nodes < 5 cm per CT scans.|Defined as the proportion of subjects who achieved CR or CRi (per the 2008 Modified International Workshop on Chronic Lymphocytic Leukemia National Cancer Institute-sponsored Working Group","Up to approximately 24 weeks after initial dose of study drug|IWCLL NCI-WG criteria).","Overall Response Rate (ORR)|Duration of Response (DoR)|Progression-Free Survival (PFS)|Time to Progression (TTP)|Overall Survival (OS)|Minimal Residual Disease (MRD) Negativity Rate","ORR is defined as the proportion of participants with an overall response (CR, CRi, nodular partial remission|DOR defined as the number of days from the date of first response (CR, CRi, nPR, or PR) (per the 2008 Modified IWCLL NCI-WG criteria) to the date of disease progression. All disease progression will be included regardless whether the event occurred during or after the participant was taking any study drug (either venetoclax, obinutuzumab, or bendamustine).|PFS is defined as the number of days from the date of first dose of any study drug (either venetoclax, obinutuzumab, or bendamustine) to the date of disease progression or death, whichever occurs first. All disease progression will be included regardless whether the event occurred during or after the participant was taking any study drug.|TPP is defined as the number of days from the date of first dose of any study drug (either venetoclax, obinutuzumab, or bendamustine) to date of disease progression. All disease progression will be included regardless whether the event occurred during or after the participant was taking any study drug.|OS is defined as number of days from the date of first dose of any study drug (either venetoclax, obinutuzumab, or bendamustine) to the date of death.|MRD negativity defined as less than one CLL cell per 10,000 leukocytes (or below 10^-4). Rate of MRD status will be defined as the proportion of participants who have MRD negativity status.","nPR plus partial remission|Up to approximately 3.5 years after initial dose of study drug","abbvieclinicaltrials@abbvie.com","ABBVIE CALL CENTER","847.283.8955","Kansas City, Missouri, United States, 64132|Eugene, Oregon, United States, 97401Principal Investigator: Jeff Sharman|Greenville, South Carolina, United States, 29615|Chattanooga, Tennessee, United States, 37404-1108 Tennessee Oncology-Sarah Cannon Research Institute /Id# 201098Nashville, Tennessee, United States, 37203|Dallas, Texas, United States, 75230|Vancouver, Washington, United States, 98684Principal Investigator: Kathryn Kolibaba","Missouri|Oregon|South Carolina|Tennessee|Texas|Washington","United States","Midamerica Division, Inc. /Id# 201099|Duplicate-Williamette Valley Cancer Institute - Eugene /Id# 201201|Greenville Health System - Int'L Dr /Id# 202329|Tennessee Oncology - Chattanooga /Id# 202840|Texas Oncology - Dallas /Id# 201196|Northwest Cancer Specialists, P.C. /Id# 201198",{"$nulls":3},"AbbVie Inc.","2018-06-06","2020-05-25T16:37:55.023","2020-05-26T17:10:42.972","NCT03406156"]
["5ecbf463feab101b1553091e","NCT03406156","2018-10-03","AbbVie","ABBV","Recruiting","A Study in Previously Untreated Chronic Lymphocytic Leukemia (CLL) Subjects, Excluding Those With the 17p Deletion, to Evaluate Debulking Regimens Prior to Initiating Venetoclax Combination Therapy","Obinutuzumab|Bendamustine|Venetoclax","CD20 Antagonist|BCL2 Inhibitor","No",null,"No",null,"Phase 3",1,100,"Anticipated","2018-08-10","2022-04-03","Complete Remission Rate","Complete Remission Rate",{"$nulls":3},"A study in previously untreated Chronic Lymphocytic Leukemia to evaluate alternate administration strategies for induction therapy (debulking) with obinutuzumab or obinutuzumab/bendamustine prior to combination therapy with obinutuzumab and venetoclax.",null,"A Phase 3b Study in Previously Untreated Chronic Lymphocytic Leukemia (CLL) Subjects, Excluding Those With the 17p Deletion, to Evaluate Debulking Regimens Prior to Initiating Venetoclax Combination Therapy","M16-788","Chronic Lymphocytic Leukemia (CLL)\nSmall Lymphocytic Lymphoma (SLL)","Leukemia|Lymphoma|Chronic Leukemia|Lymphoid Leukemia|Chronic Lymphoid Leukemia","Oncology Hematological","Oncology","Experimental","Obinutuzumab +/- bendamustine then obinutuzumab + venetoclax",null,"Drug","Obinutuzumab|Bendamustine|Venetoclax","intravenous|tablet","Gazyva|Bendeka|Venclexta | ABT-199\n | GDC-0199","Obinutuzumab +/- bendamustine then obinutuzumab + venetoclax","\n\n * Adequate hematology, kidney and liver function as described in the protocol.\n * Diagnosis of previously untreated chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) according to 2008 Modified International Workshop on Chronic Lymphocytic Leukemia National Cancer Institute-sponsored Working Group (IWCLL NCI-WG) criteria.\n * Eastern Cooperative Oncology Group (ECOG) performance score of 0 - 1.\n * CLL requires treatment according to the IWCLL criteria.\n * Medium tumor burden (any lymph node [LN] 5 to < 10 cm OR absolute lymphocyte count [ALC] >= 25 Ã— 10^9/L) OR High tumor burden (any LN >= 10 cm OR ALC >= 25 Ã— 10^9/L and LN >= 5 cm).\n\n","\n\n * Presence of 17p deletion at Screening.\n * Richter's syndrome (transformation of CLL/SLL to aggressive non-Hodgkin's lymphoma or Hodgkin's lymphoma).\n * Prolymphocytic leukemia.",{"$nulls":4},"Actual","2018-01-23","Actual","Anticipated","2024-07-17","Anticipated","2018-10-01","2018-01-16","2018-01-16","2018-10-02","Yes","Cancer\nChronic Lymphocytic Leukemia\n17p Deletion\ndebulking\nobinutuzumab\nbendamustine\ntumor lysis syndrome\nvenetoclax\nSmall Lymphocytic Lymphoma","Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No","Yes\nAbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",null,"URL: http://www.rxabbvie.com/ [http://www.rxabbvie.com/] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: Related Info",null,"Yes","No",{"$nulls":4},"No",{"$nulls":14},"Percent of Participants Achieving Low Tumor Burden Status with induction of Obinutuzumab or Obinutuzumab plus Bendamustine (Debulking Period)|Complete Remission Rate (CR) and Complete Remission with Incomplete Marrow Recovery (CRi)","Low tumor burden is defined by peripheral lymphocyte counts of < 25,000 and all lymph nodes < 5 cm per CT scans.|Defined as the proportion of subjects who achieved CR or CRi (per the 2008 Modified International Workshop on Chronic Lymphocytic Leukemia National Cancer Institute-sponsored Working Group","Up to approximately 24 weeks after initial dose of study drug|IWCLL NCI-WG criteria).","Overall Response Rate (ORR)|Duration of Response (DoR)|Progression-Free Survival (PFS)|Time to Progression (TTP)|Overall Survival (OS)|Minimal Residual Disease (MRD) Negativity Rate","ORR is defined as the proportion of participants with an overall response (CR, CRi, nodular partial remission|DOR defined as the number of days from the date of first response (CR, CRi, nPR, or PR) (per the 2008 Modified IWCLL NCI-WG criteria) to the date of disease progression. All disease progression will be included regardless whether the event occurred during or after the participant was taking any study drug (either venetoclax, obinutuzumab, or bendamustine).|PFS is defined as the number of days from the date of first dose of any study drug (either venetoclax, obinutuzumab, or bendamustine) to the date of disease progression or death, whichever occurs first. All disease progression will be included regardless whether the event occurred during or after the participant was taking any study drug.|TPP is defined as the number of days from the date of first dose of any study drug (either venetoclax, obinutuzumab, or bendamustine) to date of disease progression. All disease progression will be included regardless whether the event occurred during or after the participant was taking any study drug.|OS is defined as number of days from the date of first dose of any study drug (either venetoclax, obinutuzumab, or bendamustine) to the date of death.|MRD negativity defined as less than one CLL cell per 10,000 leukocytes (or below 10^-4). Rate of MRD status will be defined as the proportion of participants who have MRD negativity status.","nPR plus partial remission|Up to approximately 3.5 years after initial dose of study drug","abbvieclinicaltrials@abbvie.com","ABBVIE CALL CENTER","847.283.8955","Tucson, Arizona, United States, 85711-2701|Denver, Colorado, United States, 80218|Kansas City, Missouri, United States, 64132|Cincinnati, Ohio, United States, 45236-2725|Eugene, Oregon, United States, 97401-6043|Greenville, South Carolina, United States, 29615|Chattanooga, Tennessee, United States, 37404-1108 Tennessee Oncology-Sarah Cannon Research Institute /Id# 201098Nashville, Tennessee, United States, 37203|Austin, Texas, United States, 78705 Texas Oncology - Beaumont /Id# 202359Beaumont, Texas, United States, 77701-4691 Texas Oncology - Dallas /Id# 201196Dallas, Texas, United States, 75230 Texas Oncology - Mcallen /Id# 202331Mcallen, Texas, United States, 78503 Texas Oncology - San Antonio Medical Center /Id# 202332San Antonio, Texas, United States, 78240-5251 Texas Oncology - Tyler /Id# 201211Tyler, Texas, United States, 75702|Vancouver, Washington, United States, 98684","Arizona|Colorado|Missouri|Ohio|Oregon|South Carolina|Tennessee|Texas|Washington","United States","Arizona Oncology Associates, Pc-Hope /Id# 202335|Rocky Mountain Cancer Centers - Denver /Id# 202328|Midamerica Division, Inc. /Id# 201099|Oncology Hematology Care, Inc - Kenwood /Id# 202397|Willamette Valley Cancer Institute /Id# 201201|Greenville Health System - Int'L Dr /Id# 202329|Tennessee Oncology - Chattanooga /Id# 202840|Texas Oncology - Austin Midtown /Id# 201199|Northwest Cancer Specialists, P.C. /Id# 201198",{"$nulls":3},"AbbVie Inc.","2018-10-02","2020-05-25T16:37:55.603","2020-05-26T17:10:42.972","NCT03406156"]
["5ecbf463307e3d1b1f8d9d7e","NCT03406156","2018-11-14","AbbVie","ABBV","Recruiting","A Study in Previously Untreated Chronic Lymphocytic Leukemia (CLL) Subjects, Excluding Those With the 17p Deletion, to Evaluate Debulking Regimens Prior to Initiating Venetoclax Combination Therapy","Obinutuzumab|Bendamustine|Venetoclax","CD20 Antagonist|BCL2 Inhibitor","No",null,"No",null,"Phase 3",1,100,"Anticipated","2018-08-10","2022-04-03","Complete Remission Rate","Complete Remission Rate",{"$nulls":3},"A study in previously untreated Chronic Lymphocytic Leukemia to evaluate alternate administration strategies for induction therapy (debulking) with obinutuzumab or obinutuzumab/bendamustine prior to combination therapy with obinutuzumab and venetoclax.",null,"A Phase 3b Study in Previously Untreated Chronic Lymphocytic Leukemia (CLL) Subjects, Excluding Those With the 17p Deletion, to Evaluate Debulking Regimens Prior to Initiating Venetoclax Combination Therapy","M16-788","Chronic Lymphocytic Leukemia (CLL)\nSmall Lymphocytic Lymphoma (SLL)","Leukemia|Lymphoma|Chronic Leukemia|Lymphoid Leukemia|Chronic Lymphoid Leukemia","Oncology Hematological","Oncology","Experimental","Obinutuzumab +/- bendamustine then obinutuzumab + venetoclax",null,"Drug","Obinutuzumab|Bendamustine|Venetoclax","intravenous|tablet","Gazyva|Bendeka|Venclexta | ABT-199\n | GDC-0199","Obinutuzumab +/- bendamustine then obinutuzumab + venetoclax","\n\n * Adequate hematology, kidney and liver function as described in the protocol.\n * Diagnosis of previously untreated chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) according to 2008 Modified International Workshop on Chronic Lymphocytic Leukemia National Cancer Institute-sponsored Working Group (IWCLL NCI-WG) criteria.\n * Eastern Cooperative Oncology Group (ECOG) performance score of 0 - 1.\n * CLL requires treatment according to the IWCLL criteria.\n * Medium tumor burden (any lymph node [LN] 5 to < 10 cm OR absolute lymphocyte count [ALC] >= 25 Ã— 10^9/L) OR High tumor burden (any LN >= 10 cm OR ALC >= 25 Ã— 10^9/L and LN >= 5 cm).\n\n","\n\n * Presence of 17p deletion at Screening.\n * Richter's syndrome (transformation of CLL/SLL to aggressive non-Hodgkin's lymphoma or Hodgkin's lymphoma).\n * Prolymphocytic leukemia.",{"$nulls":4},"Actual","2018-01-23","Actual","Anticipated","2024-07-16","Anticipated","2018-11-01","2018-01-16","2018-01-16","2018-11-12","Yes","Cancer\nChronic Lymphocytic Leukemia\n17p Deletion\ndebulking\nobinutuzumab\nbendamustine\ntumor lysis syndrome\nvenetoclax\nSmall Lymphocytic Lymphoma","Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No","Yes\nAbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",null,"URL: http://www.rxabbvie.com/ [http://www.rxabbvie.com/] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: Related Info",null,"Yes","No",{"$nulls":4},"No",{"$nulls":14},"Percent of Participants Achieving Low Tumor Burden Status with induction of Obinutuzumab or Obinutuzumab plus Bendamustine (Debulking Period)|Complete Remission Rate (CR) and Complete Remission with Incomplete Marrow Recovery (CRi)","Low tumor burden is defined by peripheral lymphocyte counts of < 25,000 and all lymph nodes < 5 cm per CT scans.|Defined as the proportion of subjects who achieved CR or CRi (per the 2008 Modified International Workshop on Chronic Lymphocytic Leukemia National Cancer Institute-sponsored Working Group","Up to approximately 24 weeks after initial dose of study drug|IWCLL NCI-WG criteria).","Overall Response Rate (ORR)|Duration of Response (DoR)|Progression-Free Survival (PFS)|Time to Progression (TTP)|Overall Survival (OS)|Minimal Residual Disease (MRD) Negativity Rate","ORR is defined as the proportion of participants with an overall response (CR, CRi, nodular partial remission|DOR defined as the number of days from the date of first response (CR, CRi, nPR, or PR) (per the 2008 Modified IWCLL NCI-WG criteria) to the date of disease progression or death. All disease progression will be included regardless whether the event occurred during or after the participant was taking any study drug (either venetoclax, obinutuzumab, or bendamustine).|PFS is defined as the number of days from the date of first dose of any study drug (either venetoclax, obinutuzumab, or bendamustine) to the date of disease progression or death, whichever occurs first. All disease progression will be included regardless whether the event occurred during or after the participant was taking any study drug.|TPP is defined as the number of days from the date of first dose of any study drug (either venetoclax, obinutuzumab, or bendamustine) to date of disease progression. All disease progression will be included regardless whether the event occurred during or after the participant was taking any study drug.|OS is defined as number of days from the date of first dose of any study drug (either venetoclax, obinutuzumab, or bendamustine) to the date of death.|MRD negativity defined as less than one CLL cell per 10,000 leukocytes (or below 10^-4). Rate of MRD status will be defined as the proportion of participants who have MRD negativity status.","nPR plus partial remission|Up to approximately 3.5 years after initial dose of study drug","abbvieclinicaltrials@abbvie.com","ABBVIE CALL CENTER","847.283.8955","Tucson, Arizona, United States, 85711-2701|Denver, Colorado, United States, 80218|Kansas City, Missouri, United States, 64132|Cincinnati, Ohio, United States, 45236-2725|Eugene, Oregon, United States, 97401-6043|Greenville, South Carolina, United States, 29615|Chattanooga, Tennessee, United States, 37404-1108 Tennessee Oncology-Sarah Cannon Research Institute /Id# 201098Nashville, Tennessee, United States, 37203|Austin, Texas, United States, 78705 Texas Oncology - Beaumont /Id# 202359Beaumont, Texas, United States, 77701-4691 Texas Oncology - Dallas /Id# 201196Dallas, Texas, United States, 75230 Texas Oncology - Mcallen /Id# 202331Mcallen, Texas, United States, 78503 Texas Oncology - San Antonio Medical Center /Id# 202332San Antonio, Texas, United States, 78240-5251 Texas Oncology - Tyler /Id# 201211Tyler, Texas, United States, 75702|Vancouver, Washington, United States, 98684","Arizona|Colorado|Missouri|Ohio|Oregon|South Carolina|Tennessee|Texas|Washington","United States","Arizona Oncology Associates, Pc-Hope /Id# 202335|Rocky Mountain Cancer Centers - Denver /Id# 202328|Midamerica Division, Inc. /Id# 201099|Oncology Hematology Care, Inc - Kenwood /Id# 202397|Willamette Valley Cancer Institute /Id# 201201|Greenville Health System - Int'L Dr /Id# 202329|Tennessee Oncology - Chattanooga /Id# 202840|Texas Oncology - Austin Midtown /Id# 201199|Northwest Cancer Specialists, P.C. /Id# 201198",{"$nulls":3},"AbbVie Inc.","2018-11-12","2020-05-25T16:37:55.377","2020-05-26T17:10:42.972","NCT03406156"]
["5ecbf464307e3d1b1f8d9d80","NCT03406156","2019-07-29","AbbVie","ABBV","Recruiting","A Study in Previously Untreated Chronic Lymphocytic Leukemia (CLL) Subjects, Excluding Those With the 17p Deletion, to Evaluate Debulking Regimens Prior to Initiating Venetoclax Combination Therapy","Obinutuzumab|Bendamustine|Venetoclax","CD20 Antagonist|BCL2 Inhibitor","No",null,"No",null,"Phase 3",1,120,"Anticipated","2018-08-10","2022-04-03","Complete Remission Rate","Complete Remission Rate",{"$nulls":3},"A study in previously untreated Chronic Lymphocytic Leukemia to evaluate alternate administration strategies for induction therapy (debulking) with obinutuzumab or obinutuzumab/bendamustine prior to combination therapy with obinutuzumab and venetoclax.",null,"A Phase 3b Study in Previously Untreated Chronic Lymphocytic Leukemia (CLL) Subjects, Excluding Those With the 17p Deletion, to Evaluate Debulking Regimens Prior to Initiating Venetoclax Combination Therapy","M16-788","Chronic Lymphocytic Leukemia (CLL)\nSmall Lymphocytic Lymphoma (SLL)","Leukemia|Lymphoma|Chronic Leukemia|Lymphoid Leukemia|Chronic Lymphoid Leukemia","Oncology Hematological","Oncology","Experimental","Obinutuzumab +/- bendamustine then obinutuzumab + venetoclax",null,"Drug","Obinutuzumab|Bendamustine|Venetoclax","intravenous|tablet","Gazyva|Bendeka|Venclexta | ABT-199\n | GDC-0199","Obinutuzumab +/- bendamustine then obinutuzumab + venetoclax","\n\n * Adequate hematology, kidney and liver function as described in the protocol.\n * Diagnosis of previously untreated chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) according to 2008 Modified International Workshop on Chronic Lymphocytic Leukemia National Cancer Institute-sponsored Working Group (IWCLL NCI-WG) criteria.\n * Eastern Cooperative Oncology Group (ECOG) performance score of 0 - 1.\n * CLL requires treatment according to the IWCLL criteria.\n * Medium tumor burden (any lymph node [LN] 5 to < 10 cm OR absolute lymphocyte count [ALC] >= 25 Ã— 10^9/L) OR High tumor burden (any LN >= 10 cm OR ALC >= 25 Ã— 10^9/L and LN >= 5 cm).\n\n","\n\n * Presence of 17p deletion at Screening.\n * Richter's syndrome (transformation of CLL/SLL to aggressive non-Hodgkin's lymphoma or Hodgkin's lymphoma).\n * Prolymphocytic leukemia.",{"$nulls":4},"Actual","2018-01-23","Actual","Anticipated","2024-07-16","Anticipated","2019-07-01","2018-01-16","2018-01-16","2019-07-26","Yes","Cancer\nChronic Lymphocytic Leukemia\n17p Deletion\ndebulking\nobinutuzumab\nbendamustine\ntumor lysis syndrome\nvenetoclax\nSmall Lymphocytic Lymphoma","Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","18 Years","99 Years","All",null,"No","Yes\nAbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",null,"URL: http://www.rxabbvie.com/ [http://www.rxabbvie.com/] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: Related Info",null,"Yes","No",{"$nulls":4},"No",{"$nulls":14},"Percent of Participants Achieving Low Tumor Burden Status with induction of Obinutuzumab or Obinutuzumab plus Bendamustine (Debulking Period)|Complete Remission Rate (CR) and Complete Remission with Incomplete Marrow Recovery (CRi)","Low tumor burden is defined by peripheral lymphocyte counts of < 25,000 and all lymph nodes < 5 cm per CT scans.|Defined as the proportion of subjects who achieved CR or CRi (per the 2008 Modified International Workshop on Chronic Lymphocytic Leukemia National Cancer Institute-sponsored Working Group","Up to approximately 24 weeks after initial dose of study drug|IWCLL NCI-WG criteria).","Overall Response Rate (ORR)|Duration of Response (DoR)|Progression-Free Survival (PFS)|Time to Progression (TTP)|Overall Survival (OS)|Minimal Residual Disease (MRD) Negativity Rate","ORR is defined as the proportion of participants with an overall response (CR, CRi, nodular partial remission|DOR defined as the number of days from the date of first response (CR, CRi, nPR, or PR) (per the 2008 Modified IWCLL NCI-WG criteria) to the date of disease progression or death. All disease progression will be included regardless whether the event occurred during or after the participant was taking any study drug (either venetoclax, obinutuzumab, or bendamustine).|PFS is defined as the number of days from the date of first dose of any study drug (either venetoclax, obinutuzumab, or bendamustine) to the date of disease progression or death, whichever occurs first. All disease progression will be included regardless whether the event occurred during or after the participant was taking any study drug.|TPP is defined as the number of days from the date of first dose of any study drug (either venetoclax, obinutuzumab, or bendamustine) to date of disease progression. All disease progression will be included regardless whether the event occurred during or after the participant was taking any study drug.|OS is defined as number of days from the date of first dose of any study drug (either venetoclax, obinutuzumab, or bendamustine) to the date of death.|MRD negativity defined as less than one CLL cell per 10,000 leukocytes (or below 10^-4). Rate of MRD status will be defined as the proportion of participants who have MRD negativity status.","nPR plus partial remission|Up to approximately 3.5 years after initial dose of study drug","abbvieclinicaltrials@abbvie.com","ABBVIE CALL CENTER","847.283.8955","Tucson, Arizona, United States, 85711-2701|Denver, Colorado, United States, 80218|Kansas City, Missouri, United States, 64132|Cincinnati, Ohio, United States, 45236-2725|Eugene, Oregon, United States, 97401-6043|Greenville, South Carolina, United States, 29615|Chattanooga, Tennessee, United States, 37404-1108 Tennessee Oncology-Nashville Centennial /Id# 201098Nashville, Tennessee, United States, 37203-1632|Austin, Texas, United States, 78705 Texas Oncology - Beaumont /Id# 202359Beaumont, Texas, United States, 77701-4691 Texas Oncology - Dallas /Id# 201196Dallas, Texas, United States, 75230 Texas Oncology - Mcallen /Id# 202331Mcallen, Texas, United States, 78503 Texas Oncology - San Antonio Medical Center /Id# 202332San Antonio, Texas, United States, 78240-5251 Texas Oncology - Tyler /Id# 201211Tyler, Texas, United States, 75702|Vancouver, Washington, United States, 98684","Arizona|Colorado|Missouri|Ohio|Oregon|South Carolina|Tennessee|Texas|Washington","United States","Arizona Oncology Associates, Pc-Hope /Id# 202335|Rocky Mountain Cancer Centers - Denver Midtown /Id# 202328|Midamerica Division, Inc. /Id# 201099|Oncology Hematology Care, Inc - Kenwood /Id# 202397|Willamette Valley Cancer Institute /Id# 201201|Greenville Health System - Int'L Dr /Id# 202329|Tennessee Oncology - Chattanooga /Id# 202840|Texas Oncology - Austin Midtown /Id# 201199|Northwest Cancer Specialists, P.C. /Id# 201198",{"$nulls":3},"AbbVie Inc.","2019-07-26","2020-05-25T16:37:56.084","2020-05-26T17:10:42.972","NCT03406156"]
["5ecbf46311702c1b1b916afe","NCT03406156","2020-01-18","AbbVie","ABBV","Recruiting","A Study in Previously Untreated Chronic Lymphocytic Leukemia (CLL) Subjects, Excluding Those With the 17p Deletion, to Evaluate Debulking Regimens Prior to Initiating Venetoclax Combination Therapy","Obinutuzumab|Bendamustine|Venetoclax","CD20 Antagonist|BCL2 Inhibitor","No",null,"No",null,"Phase 3",1,120,"Anticipated","2018-08-10","2022-04-03","Complete Remission Rate","Complete Remission Rate",{"$nulls":3},"A study in previously untreated Chronic Lymphocytic Leukemia participants to evaluate alternate administration strategies for induction therapy (debulking) with obinutuzumab or obinutuzumab/bendamustine prior to combination therapy with obinutuzumab and venetoclax.",null,"A Phase 3b Study in Previously Untreated Chronic Lymphocytic Leukemia (CLL) Subjects, Excluding Those With the 17p Deletion, to Evaluate Debulking Regimens Prior to Initiating Venetoclax Combination Therapy","M16-788","Chronic Lymphocytic Leukemia (CLL)\nSmall Lymphocytic Lymphoma (SLL)","Leukemia|Lymphoma|Chronic Leukemia|Lymphoid Leukemia|Chronic Lymphoid Leukemia","Oncology Hematological","Oncology","Experimental","Obinutuzumab +/- bendamustine then obinutuzumab + venetoclax",null,"Drug","Obinutuzumab|Bendamustine|Venetoclax","intravenous|tablet","Gazyva|Bendeka|Venclexta | ABT-199\n | GDC-0199","Obinutuzumab +/- bendamustine then obinutuzumab + venetoclax","\n\n * Adequate hematology, kidney and liver function as described in the protocol.\n * Diagnosis of previously untreated chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) according to 2008 Modified International Workshop on Chronic Lymphocytic Leukemia National Cancer Institute-sponsored Working Group (IWCLL NCI-WG) criteria.\n * Eastern Cooperative Oncology Group (ECOG) performance score of 0 - 1.\n * CLL requires treatment according to the IWCLL criteria.\n * Medium tumor burden (any lymph node [LN] 5 to < 10 cm OR absolute lymphocyte count [ALC] >= 25 Ã— 10^9/L) OR High tumor burden (any LN >= 10 cm OR ALC >= 25 Ã— 10^9/L and LN >= 5 cm).\n\n","\n\n * Presence of 17p deletion at Screening.\n * Richter's syndrome (transformation of CLL/SLL to aggressive non-Hodgkin's lymphoma or Hodgkin's lymphoma).\n * Prolymphocytic leukemia.",{"$nulls":4},"Actual","2018-01-23","Actual","Anticipated","2024-07-16","Anticipated","2020-01-01","2018-01-16","2018-01-16","2020-01-15","Yes","Cancer\nChronic Lymphocytic Leukemia\n17p Deletion\ndebulking\nobinutuzumab\nbendamustine\ntumor lysis syndrome\nvenetoclax\nSmall Lymphocytic Lymphoma","Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","18 Years","99 Years","All",null,"No","Yes\nAbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",null,"URL: http://www.rxabbvie.com/ [http://www.rxabbvie.com/] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: Related Info",null,"Yes","No",{"$nulls":4},"No",{"$nulls":14},"Percent of Participants Achieving Low Tumor Burden Status with induction of Obinutuzumab or Obinutuzumab plus Bendamustine (Debulking Period)|Complete Remission Rate (CR) and Complete Remission with Incomplete Marrow Recovery (CRi)","Low tumor burden is defined by peripheral lymphocyte counts of < 25,000 and all lymph nodes < 5 cm per CT scans.|Defined as the proportion of subjects who achieved CR or CRi (per the 2008 Modified International Workshop on Chronic Lymphocytic Leukemia National Cancer Institute-sponsored Working Group","Up to approximately 24 weeks after initial dose of study drug|IWCLL NCI-WG criteria).","Overall Response Rate (ORR)|Duration of Response (DoR)|Progression-Free Survival (PFS)|Time to Progression (TTP)|Overall Survival (OS)|Undetectable Minimal Residual Disease (UMRD) Rate","ORR is defined as the proportion of participants with an overall response (CR, CRi, nodular partial remission|DOR defined as the number of days from the date of first response (CR, CRi, nPR, or PR) (per the 2008 Modified IWCLL NCI-WG criteria) to the date of disease progression or death. All disease progression will be included regardless whether the event occurred during or after the participant was taking any study drug (either venetoclax, obinutuzumab, or bendamustine).|PFS is defined as the number of days from the date of first dose of any study drug (either venetoclax, obinutuzumab, or bendamustine) to the date of disease progression or death, whichever occurs first. All disease progression will be included regardless whether the event occurred during or after the participant was taking any study drug.|TPP is defined as the number of days from the date of first dose of any study drug (either venetoclax, obinutuzumab, or bendamustine) to date of disease progression. All disease progression will be included regardless whether the event occurred during or after the participant was taking any study drug.|OS is defined as number of days from the date of first dose of any study drug (either venetoclax, obinutuzumab, or bendamustine) to the date of death.|UMRD defined as less than one CLL cell per 10,000 leukocytes (or below 10^-4). Rate of UMRD status will be defined as the percentage of participants who have UMRD.","nPR plus partial remission|Up to approximately 3.5 years after initial dose of study drug","abbvieclinicaltrials@abbvie.com","ABBVIE CALL CENTER","847.283.8955","Tucson, Arizona, United States, 85711-2701|Denver, Colorado, United States, 80218|Kansas City, Missouri, United States, 64132|Cincinnati, Ohio, United States, 45236-2725|Eugene, Oregon, United States, 97401-6043|Greenville, South Carolina, United States, 29615|Chattanooga, Tennessee, United States, 37404-1108 Tennessee Oncology-Nashville Centennial /Id# 201098Nashville, Tennessee, United States, 37203-1632|Austin, Texas, United States, 78705 Texas Oncology - Beaumont /Id# 202359Beaumont, Texas, United States, 77701-4691 Texas Oncology - Medical City Dallas /Id# 201196Dallas, Texas, United States, 75230 Texas Oncology - Mcallen /Id# 202331Mcallen, Texas, United States, 78503 Texas Oncology - San Antonio Medical Center /Id# 202332San Antonio, Texas, United States, 78240-5251 Texas Oncology - Tyler /Id# 201211Tyler, Texas, United States, 75702|Vancouver, Washington, United States, 98684","Arizona|Colorado|Missouri|Ohio|Oregon|South Carolina|Tennessee|Texas|Washington","United States","Arizona Oncology Associates, Pc-Hope /Id# 202335|Rocky Mountain Cancer Centers - Denver Midtown /Id# 202328|Midamerica Division, Inc. /Id# 201099|Oncology Hematology Care, Inc - Kenwood /Id# 202397|Willamette Valley Cancer Institute /Id# 201201|Greenville Health System - Int'L Dr /Id# 202329|Tennessee Oncology - Chattanooga /Id# 202840|Texas Oncology - Austin Midtown /Id# 201199|Northwest Cancer Specialists, P.C. /Id# 201198",{"$nulls":3},"AbbVie Inc.","2020-01-15","2020-05-25T16:37:55.730","2020-05-26T17:10:42.972","NCT03406156"]
["5ecbf464feab101b1553091f","NCT03406260","2018-03-20","Eli Lilly","LLY","Recruiting","A Study of Lasmiditan in Healthy Elderly Participants","Lasmiditan","5-HT1F Agonist","Yes","['Lasmiditan']","Yes","['5-HT1F Agonist']","Phase 1",3,36,"Anticipated","2018-01-25","2018-04-01","SBP","Systolic Blood Pressure",{"$nulls":3},"The purposes of this study are to evaluate the effect of lasmiditan on blood pressure, as well as to look at the amount of study drug that gets into the blood stream and how long it takes the body to get rid of it in healthy elderly participants. The tolerability of the study drug will also be evaluated. Information about any side effects that may occur will also be collected. This study will take about 11 days, not including screening. Screening is required within 28 days prior to the start of the study.",null,"A Study to Investigate the Cardiovascular Effects of Lasmiditan in Healthy Elderly Subjects",17062,"Healthy","Healthy Volunteers|Other","Healthy|Other","Healthy|Other","Experimental|Placebo Comparator","Lasmiditan Dose 1 (Treatment A)|Lasmiditan Dose 2 (Treatment B)|Placebo (Treatment C)","Lasmiditan Dose 1 administered orally in one of three treatment periods.|Lasmiditan Dose 2 administered orally in one of three treatment periods.|Placebo administered orally in one of three treatment periods.","Drug","Lasmiditan|Placebo","Administered orally.","LY573144","Lasmiditan Dose 1 (Treatment A)|Lasmiditan Dose 2 (Treatment B)|Placebo (Treatment C)","\n\n * Are overtly healthy males or females, as determined through medical history and physical examination\n * Have a body mass index (BMI) of 19.0 to 35.0 kilograms per meter squared (kg/mÂ²), inclusive, at the time of screening.\n\n","\n\n * Have known allergies to lasmiditan, related compounds, or any components of the formulation.\n * Are persons who have previously received lasmiditan.\n * Have a history of, or electrocardiogram (ECG) findings of, clinically significant bradycardia, heart block, tachy or brady arrhythmias, or have any other abnormality in the 12-lead ECG that, in the opinion of the investigator, increases the risks associated with participating in the study.\n * Have significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data. appendectomy, splenectomy, and cholecystectomy are considered as acceptable.\n * Show a history of central nervous system (CNS) conditions such as strokes, transient ischemic attacks, significant head trauma, seizures, CNS infections, migraines, brain surgery, or any other neurological conditions that, in the opinion of the investigator, increase the risk of participating in the study.\n * Show evidence of active renal disease (e.g. diabetic renal disease, polycystic kidney disease) or estimated glomerular filtration rate <60 milliliters per minute per 1.73 meter squared (mL/min/mÂ²).\n * Have a history of syncope, presyncopy, uncontrolled vertigo, postural dizziness, or at risk for falls, as judged to be clinically significant by the investigator.",{"$nulls":4},"Actual","2018-01-23","Actual","Anticipated","2018-04-01","Anticipated","2018-03-01","2018-01-16","2018-01-16","2018-03-19","No",null,"Interventional","Basic Science","Crossover Assignment","Double (Participant, Investigator)","Randomized","65 Years",null,"All",null,"Yes",{"$nulls":4},"Yes","No",{"$nulls":17},"H8H-MC-LAIG","Eli Lilly and Company","Pharmacodynamics: Change from Baseline in Systolic Blood Pressure (SBP)","SBP measured via ambulatory blood pressure monitoring (ABPM)","Baseline through 24 hours after each administration of study drug","Pharmacokinetics (PK): Maximum Concentration (Cmax) of Lasmiditan|PK: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-âˆž]) of Lasmiditan","PK: Cmax of lasmiditan|PK: AUC(0-âˆž) of lasmiditan","Baseline through 48 hours after administration of study drug","ClinicalTrials.gov@lilly.com","There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or","1-317-615-4559","Daytona Beach, Florida, United States, 32117|Madison, Wisconsin, United States, 53704","Florida|Wisconsin","United States","Covance Clinical Research Inc",{"$nulls":3},"Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)","2018-03-19","2020-05-25T16:37:56.392","2020-05-26T17:10:42.972","NCT03406260"]
["5ecbf464fe30261b1a0482f0","NCT03406260","2018-04-17","Eli Lilly","LLY","Active, not recruiting","A Study of Lasmiditan in Healthy Elderly Participants","Lasmiditan","5-HT1F Agonist","Yes","['Lasmiditan']","Yes","['5-HT1F Agonist']","Phase 1",3,36,"Actual","2018-01-25","2018-04-01","SBP","Systolic Blood Pressure",{"$nulls":3},"The purposes of this study are to evaluate the effect of lasmiditan on blood pressure, as well as to look at the amount of study drug that gets into the blood stream and how long it takes the body to get rid of it in healthy elderly participants. The tolerability of the study drug will also be evaluated. Information about any side effects that may occur will also be collected. This study will take about 11 days, not including screening. Screening is required within 28 days prior to the start of the study.",null,"A Study to Investigate the Cardiovascular Effects of Lasmiditan in Healthy Elderly Subjects",17062,"Healthy","Healthy Volunteers|Other","Healthy|Other","Healthy|Other","Experimental|Placebo Comparator","Lasmiditan Dose 1 (Treatment A)|Lasmiditan Dose 2 (Treatment B)|Placebo (Treatment C)","Lasmiditan Dose 1 administered orally in one of three treatment periods.|Lasmiditan Dose 2 administered orally in one of three treatment periods.|Placebo administered orally in one of three treatment periods.","Drug","Lasmiditan|Placebo","Administered orally.","LY573144","Lasmiditan Dose 1 (Treatment A)|Lasmiditan Dose 2 (Treatment B)|Placebo (Treatment C)","\n\n * Are overtly healthy males or females, as determined through medical history and physical examination\n * Have a body mass index (BMI) of 19.0 to 35.0 kilograms per meter squared (kg/mÂ²), inclusive, at the time of screening.\n\n","\n\n * Have known allergies to lasmiditan, related compounds, or any components of the formulation.\n * Are persons who have previously received lasmiditan.\n * Have a history of, or electrocardiogram (ECG) findings of, clinically significant bradycardia, heart block, tachy or brady arrhythmias, or have any other abnormality in the 12-lead ECG that, in the opinion of the investigator, increases the risks associated with participating in the study.\n * Have significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data. appendectomy, splenectomy, and cholecystectomy are considered as acceptable.\n * Show a history of central nervous system (CNS) conditions such as strokes, transient ischemic attacks, significant head trauma, seizures, CNS infections, migraines, brain surgery, or any other neurological conditions that, in the opinion of the investigator, increase the risk of participating in the study.\n * Show evidence of active renal disease (e.g. diabetic renal disease, polycystic kidney disease) or estimated glomerular filtration rate <60 milliliters per minute per 1.73 meter squared (mL/min/mÂ²).\n * Have a history of syncope, presyncopy, uncontrolled vertigo, postural dizziness, or at risk for falls, as judged to be clinically significant by the investigator.",{"$nulls":4},"Actual","2018-01-23","Actual","Anticipated","2018-04-01","Anticipated","2018-04-01","2018-01-16","2018-01-16","2018-04-13","No",null,"Interventional","Basic Science","Crossover Assignment","Double (Participant, Investigator)","Randomized","65 Years",null,"All",null,"Yes",{"$nulls":4},"Yes","No",{"$nulls":17},"H8H-MC-LAIG","Eli Lilly and Company","Pharmacodynamics: Change from Baseline in Systolic Blood Pressure (SBP)","SBP measured via ambulatory blood pressure monitoring (ABPM)","Baseline through 24 hours after each administration of study drug","Pharmacokinetics (PK): Maximum Concentration (Cmax) of Lasmiditan|PK: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-âˆž]) of Lasmiditan","PK: Cmax of lasmiditan|PK: AUC(0-âˆž) of lasmiditan","Baseline through 48 hours after administration of study drug",{"$nulls":3},"Daytona Beach, Florida, United States, 32117|Madison, Wisconsin, United States, 53704","Florida|Wisconsin","United States","Covance Clinical Research Inc",{"$nulls":3},"Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)","2018-04-13","2020-05-25T16:37:56.505","2020-05-26T17:10:42.972","NCT03406260"]
["5ecbf464307e3d1b1f8d9d81","NCT03406260","2019-12-02","Eli Lilly","LLY","Completed","A Study of Lasmiditan in Healthy Elderly Participants","Lasmiditan","5-HT1F Agonist","Yes","['Lasmiditan']","Yes","['5-HT1F Agonist']","Phase 1",3,36,"Actual","2018-01-25","2018-04-13",{"$nulls":5},"The purposes of this study are to evaluate the effect of lasmiditan on blood pressure, as well as to look at the amount of study drug that gets into the blood stream and how long it takes the body to get rid of it in healthy elderly participants. The tolerability of the study drug will also be evaluated. Information about any side effects that may occur will also be collected. This study will take about 11 days, not including screening. Screening is required within 28 days prior to the start of the study.",null,"A Study to Investigate the Cardiovascular Effects of Lasmiditan in Healthy Elderly Subjects",17062,"Healthy","Healthy Volunteers|Other","Healthy|Other","Healthy|Other","Experimental|Placebo Comparator","Lasmiditan 200 mg (milligrams)|Lasmiditan 100 mg|Placebo","Participants received 200 mg of Lasmiditan tablet orally in the fasted state with approximately 240 (milliliter) mL of room temperature water in the morning of Days 1, 3, and 5, while participants were in a sitting position.|Participants received 100 mg of Lasmiditan tablet orally in the fasted state with approximately 240 mL of room temperature water in the morning of Days 1, 3, and 5, while participants were in a sitting position.|Participants received placebo tablet orally in the fasted state with approximately 240 mL of room temperature water in the morning of Days 1, 3, and 5, while participants were in a sitting position.","Drug","Lasmiditan|Placebo","Administered orally.","LY573144","Lasmiditan 200 mg (milligrams)|Lasmiditan 100 mg|Placebo","\n\n * Are overtly healthy males or females, as determined through medical history and physical examination\n * Have a body mass index (BMI) of 19.0 to 35.0 kilograms per meter squared (kg/mÂ²), inclusive, at the time of screening.\n\n","\n\n * Have known allergies to lasmiditan, related compounds, or any components of the formulation.\n * Are persons who have previously received lasmiditan.\n * Have a history of, or electrocardiogram (ECG) findings of, clinically significant bradycardia, heart block, tachy or brady arrhythmias, or have any other abnormality in the 12-lead ECG that, in the opinion of the investigator, increases the risks associated with participating in the study.\n * Have significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data. appendectomy, splenectomy, and cholecystectomy are considered as acceptable.\n * Show a history of central nervous system (CNS) conditions such as strokes, transient ischemic attacks, significant head trauma, seizures, CNS infections, migraines, brain surgery, or any other neurological conditions that, in the opinion of the investigator, increase the risk of participating in the study.\n * Show evidence of active renal disease (e.g. diabetic renal disease, polycystic kidney disease) or estimated glomerular filtration rate <60 milliliters per minute per 1.73 meter squared (mL/min/mÂ²).\n * Have a history of syncope, presyncopy, uncontrolled vertigo, postural dizziness, or at risk for falls, as judged to be clinically significant by the investigator.",{"$nulls":4},"Actual","2018-01-23","Actual","Actual","2018-04-13","Actual","2018-05-01","2018-01-16","2018-01-16","2019-11-08","No",null,"Interventional","Basic Science","Crossover Assignment","Double (Participant, Investigator)","Randomized","65 Years",null,"All",null,"Yes","No",{"$nulls":3},"Yes","No","2019-11-08","2019-11-08","2019-12-02","Actual",{"$nulls":13},"H8H-MC-LAIG","Eli Lilly and Company",{"$nulls":9},"Daytona Beach, Florida, United States, 32117|Madison, Wisconsin, United States, 53704","Florida|Wisconsin","United States","Covance Clinical Research Inc",{"$nulls":3},"Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)","2019-11-08","2020-05-25T16:37:56.607","2020-05-26T17:10:42.972","NCT03406260"]
["5ecbf46711702c1b1b916b05","NCT03406507","2018-03-21","Alexion","ALXN","Recruiting","A Phase 3, Open-Label Study of ALXN1210 in Children and Adolescents With Paroxysmal Nocturnal Hemoglobinuria (PNH)","Ravulizumab","C5 Inhibitor","Yes","['Ravulizumab']","No",null,"Phase 3",1,12,"Anticipated","2018-02-22","2019-08-01",{"$nulls":5},"The purpose of this study is to assess the pharmacokinetics (PK), pharmacodynamics (PD), safety, and efficacy of ALXN1210 in pediatric patients with paroxysmal nocturnal hemoglobinuria (PNH).",null,"A Phase 3, Open-Label Study of ALXN1210 in Children and Adolescents With Paroxysmal Nocturnal Hemoglobinuria (PNH)","ALXN1210-PNH-304","Paroxysmal Nocturnal Hemoglobinuria (PNH)","Paroxysmal Hemoglobinuria|Paroxysmal Nocturnal Hemoglobinuria|Hemoglobinuria","Hematologic Diseases|Urologic Diseases","Heme & Lymph Diseases|Reproductive and Urogenital","Experimental","ALXN1210",null,"Biological","ALXN1210","Single loading dose on Day 1, followed by regular maintenance dosing beginning on Day 15, based on weight.",null,"ALXN1210","\n\n 1. Patients from birth up to < 18 years of age and weighing â‰¥ 5 kg at the time of consent.\n 2. PNH diagnosis confirmed by documented by high-sensitivity flow cytometry\n 3. Presence of 1 or more of the following PNH-related signs or symptoms within 3 months of Screening: fatigue, hemoglobinuria, abdominal pain, shortness of breath (dyspnea), anemia, history of a major adverse vascular event (including thrombosis), dysphagia, or erectile dysfunction; or history of pRBC transfusion due to PNH.\n 4. LDH level â‰¥ 1.5 Ã— ULN for patients not being treated with eculizumab at screening and LDH level â‰¤ 1.5 Ã— ULN for patients taking eculizumab.\n 5. Documented meningococcal vaccination not more than 3 years prior to dosing, and vaccination against Streptococcus pneumoniae and Haemophilus influenzae\n 6. Female patients of childbearing potential must use highly effective contraception starting at screening and continuing until at least 8 months after the last dose of ALXN1210\n\n","\n\n 1. History of Bone Marrow transplantation\n 2. History of or ongoing major cardiac, pulmonary, renal, endocrine, or hepatic disease that, in the opinion of the investigator or sponsor, would preclude participation.\n 3. Unstable medical conditions (eg, myocardial ischemia, active gastrointestinal bleed, severe congestive heart failure, anticipated need for major surgery within 6 months of randomization, coexisting chronic anemia unrelated to PNH)\n 4. Females who are pregnant, breastfeeding or who have a positive pregnancy test at screening or Day 1\n 5. Participation in another interventional clinical study or use of any experimental therapy within 30 days before initiation of study drug on Day 1 in this study or within 5 half-lives of that investigational product, whichever is greater.",{"$nulls":4},"Actual","2018-01-23","Actual","Anticipated","2021-06-01","Anticipated","2018-03-01","2018-01-05","2018-01-14","2018-03-20","Yes",null,"Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A",null,"18 Years","All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"2017â€\u0090002820â€\u009026","EudraCT Number","Cmax (pharmacokinetic parameter)|Ctrough (pharmacokinetic parameter)|accumulation ratio (pharmacokinetic parameter)|free C5 concentrations (pharmacodynamic parameter)|cRBC (pharmacodynamic parameter)","Maximum serum concentration|Trough serum concentration (measured at end of dosing interval at steady state|Baseline, Week 2, 10, 18, and 26|Change in free C5 concentrations over time|Change in chicken red blood cell (cRBC) hemolytic activity over time","Baseline, Week 2, 10, 18, and 26","Change in lactate dehydrogenase ( LDH) level|Proportion of patients who achieve transfusion avoidance (TA)","The percentage change from baseline to Week 26 in serum lactate dehydrogenase (LDH) levels will be compared|TA is defined as the proportion of patients who remain transfusion-free and do not require a transfusion according to protocol-specified guidelines.","26 weeks","clinicaltrials@alexion.com","Alexion Pharmaceuticals, Inc","1.855.585.8266","London, United Kingdom",null,"United Kingdom","Clinical Trial Site",{"$nulls":4},"2018-03-20","2020-05-25T16:37:59.323","2020-05-26T17:10:42.972","NCT03406507"]
["5ecbf467307e3d1b1f8d9d87","NCT03406507","2018-08-31","Alexion","ALXN","Recruiting","A Phase 3, Open-Label Study of ALXN1210 in Children and Adolescents With Paroxysmal Nocturnal Hemoglobinuria (PNH)","Ravulizumab","C5 Inhibitor","Yes","['Ravulizumab']","No",null,"Phase 3",1,12,"Anticipated","2018-02-22","2019-08-01",{"$nulls":5},"The purpose of this study is to assess the pharmacokinetics (PK), pharmacodynamics (PD), safety, and efficacy of ALXN1210 in pediatric patients with paroxysmal nocturnal hemoglobinuria (PNH).",null,"A Phase 3, Open-Label Study of ALXN1210 in Children and Adolescents With Paroxysmal Nocturnal Hemoglobinuria (PNH)","ALXN1210-PNH-304","Paroxysmal Nocturnal Hemoglobinuria (PNH)","Paroxysmal Hemoglobinuria|Paroxysmal Nocturnal Hemoglobinuria|Hemoglobinuria","Hematologic Diseases|Urologic Diseases","Heme & Lymph Diseases|Reproductive and Urogenital","Experimental","ALXN1210",null,"Biological","ALXN1210","Single loading dose on Day 1, followed by regular maintenance dosing beginning on Day 15, based on weight.",null,"ALXN1210","\n\n 1. Patients from birth up to < 18 years of age and weighing â‰¥ 5 kg at the time of consent.\n 2. PNH diagnosis confirmed by documented by high-sensitivity flow cytometry\n 3. Presence of 1 or more of the following PNH-related signs or symptoms within 3 months of Screening: fatigue, hemoglobinuria, abdominal pain, shortness of breath (dyspnea), anemia, history of a major adverse vascular event (including thrombosis), dysphagia, or erectile dysfunction; or history of pRBC transfusion due to PNH.\n 4. LDH level â‰¥ 1.5 Ã— ULN for patients not being treated with eculizumab at screening and LDH level â‰¤ 1.5 Ã— ULN for patients taking eculizumab.\n 5. Documented meningococcal vaccination not more than 3 years prior to dosing, and vaccination against Streptococcus pneumoniae and Haemophilus influenzae\n 6. Female patients of childbearing potential must use highly effective contraception starting at screening and continuing until at least 8 months after the last dose of ALXN1210\n\n","\n\n 1. History of Bone Marrow transplantation\n 2. History of or ongoing major cardiac, pulmonary, renal, endocrine, or hepatic disease that, in the opinion of the investigator or sponsor, would preclude participation.\n 3. Unstable medical conditions (eg, myocardial ischemia, active gastrointestinal bleed, severe congestive heart failure, anticipated need for major surgery within 6 months of randomization, coexisting chronic anemia unrelated to PNH)\n 4. Females who are pregnant, breastfeeding or who have a positive pregnancy test at screening or Day 1\n 5. Participation in another interventional clinical study or use of any experimental therapy within 30 days before initiation of study drug on Day 1 in this study or within 5 half-lives of that investigational product, whichever is greater.",{"$nulls":4},"Actual","2018-01-23","Actual","Anticipated","2021-06-01","Anticipated","2018-08-01","2018-01-05","2018-01-14","2018-08-29","Yes",null,"Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A",null,"18 Years","All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"2017â€\u0090002820â€\u009026","EudraCT Number","Cmax (pharmacokinetic parameter)|Ctrough (pharmacokinetic parameter)|accumulation ratio (pharmacokinetic parameter)|free C5 concentrations (pharmacodynamic parameter)|cRBC (pharmacodynamic parameter)","Maximum serum concentration|Trough serum concentration (measured at end of dosing interval at steady state|Baseline, Week 2, 10, 18, and 26|Change in free C5 concentrations over time|Change in chicken red blood cell (cRBC) hemolytic activity over time","Baseline, Week 2, 10, 18, and 26","Change in lactate dehydrogenase ( LDH) level|Proportion of patients who achieve transfusion avoidance (TA)","The percentage change from baseline to Week 26 in serum lactate dehydrogenase (LDH) levels will be compared|TA is defined as the proportion of patients who remain transfusion-free and do not require a transfusion according to protocol-specified guidelines.","26 weeks","clinicaltrials@alexion.com","Alexion Pharmaceuticals, Inc","1.855.585.8266","Paris, France|Utrecht, Netherlands|Leeds, United Kingdom Clinical Trial SiteLondon, United Kingdom",null,"France|Netherlands|United Kingdom","Clinical Trial Site",{"$nulls":4},"2018-08-29","2020-05-25T16:37:59.436","2020-05-26T17:10:42.972","NCT03406507"]
["5ecbf467feab101b15530926","NCT03406507","2019-01-09","Alexion","ALXN","Recruiting","A Phase 3, Open-Label Study of ALXN1210 in Children and Adolescents With Paroxysmal Nocturnal Hemoglobinuria (PNH)","Ravulizumab","C5 Inhibitor","No",null,"No",null,"Phase 3",1,12,"Anticipated","2018-02-22","2019-08-01",{"$nulls":5},"The purpose of this study is to assess the pharmacokinetics (PK), pharmacodynamics (PD), safety, and efficacy of ALXN1210 in pediatric patients with paroxysmal nocturnal hemoglobinuria (PNH).",null,"A Phase 3, Open-Label Study of ALXN1210 in Children and Adolescents With Paroxysmal Nocturnal Hemoglobinuria (PNH)","ALXN1210-PNH-304","Paroxysmal Nocturnal Hemoglobinuria (PNH)","Paroxysmal Hemoglobinuria|Paroxysmal Nocturnal Hemoglobinuria|Hemoglobinuria","Hematologic Diseases|Urologic Diseases","Heme & Lymph Diseases|Reproductive and Urogenital","Experimental","ALXN1210",null,"Biological","ALXN1210","Single loading dose on Day 1, followed by regular maintenance dosing beginning on Day 15, based on weight.",null,"ALXN1210","\n\n 1. Patients from birth up to < 18 years of age and weighing â‰¥ 5 kg at the time of consent.\n 2. PNH diagnosis confirmed by documented by high-sensitivity flow cytometry\n 3. Presence of 1 or more of the following PNH-related signs or symptoms within 3 months of Screening: fatigue, hemoglobinuria, abdominal pain, shortness of breath (dyspnea), anemia, history of a major adverse vascular event (including thrombosis), dysphagia, or erectile dysfunction; or history of pRBC transfusion due to PNH.\n 4. LDH level â‰¥ 1.5 Ã— ULN for patients not being treated with eculizumab at screening and LDH level â‰¤ 1.5 Ã— ULN for patients taking eculizumab.\n 5. Documented meningococcal vaccination not more than 3 years prior to dosing, and vaccination against Streptococcus pneumoniae and Haemophilus influenzae\n 6. Female patients of childbearing potential must use highly effective contraception starting at screening and continuing until at least 8 months after the last dose of ALXN1210\n\n","\n\n 1. History of Bone Marrow transplantation\n 2. History of or ongoing major cardiac, pulmonary, renal, endocrine, or hepatic disease that, in the opinion of the investigator or sponsor, would preclude participation.\n 3. Unstable medical conditions (eg, myocardial ischemia, active gastrointestinal bleed, severe congestive heart failure, anticipated need for major surgery within 6 months of randomization, coexisting chronic anemia unrelated to PNH)\n 4. Females who are pregnant, breastfeeding or who have a positive pregnancy test at screening or Day 1\n 5. Participation in another interventional clinical study or use of any experimental therapy within 30 days before initiation of study drug on Day 1 in this study or within 5 half-lives of that investigational product, whichever is greater.",{"$nulls":4},"Actual","2018-01-23","Actual","Anticipated","2021-06-01","Anticipated","2018-12-01","2018-01-05","2018-01-14","2019-01-08","Yes",null,"Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A",null,"18 Years","All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"2017â€\u0090002820â€\u009026","EudraCT Number","Cmax (pharmacokinetic parameter)|Ctrough (pharmacokinetic parameter)|accumulation ratio (pharmacokinetic parameter)|free C5 concentrations (pharmacodynamic parameter)|cRBC (pharmacodynamic parameter)","Maximum serum concentration|Trough serum concentration (measured at end of dosing interval at steady state|Baseline, Week 2, 10, 18, and 26|Change in free C5 concentrations over time|Change in chicken red blood cell (cRBC) hemolytic activity over time","Baseline, Week 2, 10, 18, and 26","Change in lactate dehydrogenase ( LDH) level|Proportion of patients who achieve transfusion avoidance (TA)","The percentage change from baseline to Week 26 in serum lactate dehydrogenase (LDH) levels will be compared|TA is defined as the proportion of patients who remain transfusion-free and do not require a transfusion according to protocol-specified guidelines.","26 weeks","clinicaltrials@alexion.com","Alexion Pharmaceuticals, Inc","1.855.585.8266","Paris, France|Utrecht, Netherlands|Leeds, United Kingdom Clinical Trial SiteLondon, United Kingdom|Atlanta, Georgia, United States, 30322|Milwaukee, Wisconsin, United States, 53226","Georgia|Wisconsin","France|Netherlands|United Kingdom|United States","Clinical Trial Site",{"$nulls":4},"2019-01-08","2020-05-25T16:37:59.518","2020-05-26T17:10:42.972","NCT03406507"]
["5ecbf467fe30261b1a0482f7","NCT03406507","2019-10-16","Alexion","ALXN","Recruiting","A Phase 3, Open-Label Study of ALXN1210 in Children and Adolescents With Paroxysmal Nocturnal Hemoglobinuria (PNH)","Ravulizumab","C5 Inhibitor","No",null,"No",null,"Phase 3",1,12,"Anticipated","2018-02-22","2020-08-01",{"$nulls":5},"The purpose of this study is to assess the pharmacokinetics (PK), pharmacodynamics (PD), safety, and efficacy of ALXN1210 in pediatric patients with paroxysmal nocturnal hemoglobinuria (PNH).",null,"A Phase 3, Open-Label Study of ALXN1210 in Children and Adolescents With Paroxysmal Nocturnal Hemoglobinuria (PNH)","ALXN1210-PNH-304","Paroxysmal Nocturnal Hemoglobinuria (PNH)","Paroxysmal Hemoglobinuria|Paroxysmal Nocturnal Hemoglobinuria|Hemoglobinuria","Hematologic Diseases|Urologic Diseases","Heme & Lymph Diseases|Reproductive and Urogenital","Experimental","ALXN1210",null,"Biological","ALXN1210","Single loading dose on Day 1, followed by regular maintenance dosing beginning on Day 15, based on weight.",null,"ALXN1210","\n\n 1. Patients from birth up to < 18 years of age and weighing â‰¥ 5 kg at the time of consent.\n 2. PNH diagnosis confirmed by documented by high-sensitivity flow cytometry\n 3. Presence of 1 or more of the following PNH-related signs or symptoms within 3 months of Screening: fatigue, hemoglobinuria, abdominal pain, shortness of breath (dyspnea), anemia, history of a major adverse vascular event (including thrombosis), dysphagia, or erectile dysfunction; or history of pRBC transfusion due to PNH.\n 4. LDH level â‰¥ 1.5 Ã— ULN for patients not being treated with eculizumab at screening and LDH level â‰¤ 1.5 Ã— ULN for patients taking eculizumab.\n 5. Documented meningococcal vaccination not more than 3 years prior to dosing, and vaccination against Streptococcus pneumoniae and Haemophilus influenzae\n 6. Female patients of childbearing potential must use highly effective contraception starting at screening and continuing until at least 8 months after the last dose of ALXN1210\n\n","\n\n 1. History of Bone Marrow transplantation\n 2. History of or ongoing major cardiac, pulmonary, renal, endocrine, or hepatic disease that, in the opinion of the investigator or sponsor, would preclude participation.\n 3. Unstable medical conditions (eg, myocardial ischemia, active gastrointestinal bleed, severe congestive heart failure, anticipated need for major surgery within 6 months of randomization, coexisting chronic anemia unrelated to PNH)\n 4. Females who are pregnant, breastfeeding or who have a positive pregnancy test at screening or Day 1\n 5. Participation in another interventional clinical study or use of any experimental therapy within 30 days before initiation of study drug on Day 1 in this study or within 5 half-lives of that investigational product, whichever is greater.",{"$nulls":4},"Actual","2018-01-23","Actual","Anticipated","2022-08-01","Anticipated","2019-10-01","2018-01-05","2018-01-14","2019-10-15","Yes",null,"Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A",null,"18 Years","All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"2017â€\u0090002820â€\u009026","EudraCT Number","Cmax (pharmacokinetic parameter)|Ctrough (pharmacokinetic parameter)|accumulation ratio (pharmacokinetic parameter)|free C5 concentrations (pharmacodynamic parameter)|cRBC (pharmacodynamic parameter)","Maximum serum concentration|Trough serum concentration (measured at end of dosing interval at steady state|Baseline, Week 2, 10, 18, and 26|Change in free C5 concentrations over time|Change in chicken red blood cell (cRBC) hemolytic activity over time","Baseline, Week 2, 10, 18, and 26","Change in lactate dehydrogenase ( LDH) level|Proportion of patients who achieve transfusion avoidance (TA)","The percentage change from baseline to Week 26 in serum lactate dehydrogenase (LDH) levels will be compared|TA is defined as the proportion of patients who remain transfusion-free and do not require a transfusion according to protocol-specified guidelines.","26 weeks","clinicaltrials@alexion.com","Alexion Pharmaceuticals, Inc","1.855.752.2356","Paris, France|Utrecht, Netherlands|Oslo, Norway Russian Federation Clinical Trial SiteMoscow, Russian Federation Clinical Trial SiteSaint Petersburg, Russian Federation|Leeds, United Kingdom Clinical Trial SiteLondon, United Kingdom|Atlanta, Georgia, United States, 30322|Milwaukee, Wisconsin, United States, 53226","Georgia|Wisconsin","France|Netherlands|Norway|United Kingdom|United States","Clinical Trial Site",{"$nulls":4},"2019-10-15","2020-05-25T16:37:59.750","2020-05-26T17:10:42.972","NCT03406507"]
["5ecbf46afe30261b1a0482fc","NCT03406702","2018-01-23","Jazz","JAZZ","Recruiting","A Phase 2 Study of CX-8998 in Adolescents and Young Adults With Generalized Epileptic Syndromes With Absence Seizures","Cx-8998",null,"Yes","['Cx-8998']","Unknown",null,"Phase 2",2,30,"Anticipated","2018-01-31","2018-11-25",{"$nulls":5},"This is a Phase 2a, multicenter, double-blind, placebo-controlled, parallel-group study consisting of a screening period of up to 4 weeks, a 4 week randomized double-blind, dose-titration treatment period, followed by a 1 week safety follow-up period after the last dose of study medication.","This is a Phase 2a, multicenter, double-blind, placebo-controlled, parallel-group study consisting of a screening period of up to 4 weeks, a 4 week randomized double-blind, dose-titration treatment period, followed by a 1 week safety follow-up period after the last dose of study medication.\n\nSubjects will be randomized 1:1 to one of two treatment groups. Group A will receive titrating doses of CX-8998 up to 10 mg BID and Group B will receive placebo.\n\nSubjects will participate for a total of up to 9 weeks, including screening, the 4-week treatment period and follow-up.","A Phase 2a, Safety, Tolerability, Pharmacokinetics and Quantitative EEG Study of CX-8998 in Adolescents and Young Adults With Generalized Epileptic Syndromes With Absence Seizures","CX-8998-CLN2-002","Epilepsy","Epilepsy","Central Nervous System Diseases","Central Nervous System","Experimental|Placebo Comparator","CX-8998|Placebo","T-type calcium channel blocker|Placebo Comparator","Drug","CX-8998|Placebo Comparator","T-type calcium channel blocker|placebo comparator",null,"CX-8998|Placebo","\n\n 1.  Signed informed consent form (ICF) indicating that the subject has been informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential benefits, side effects, risks, and discomforts.\n 2.  Men or non-pregnant, non-breastfeeding women 16 to 45 years-of-age who are able to read and understand written and spoken local language.\n 3.  Diagnosis: Clinical diagnosis of an epileptic syndrome (including, but not limited to, childhood absence epilepsy, juvenile absence epilepsy, juvenile myoclonic epilepsy, or Jeavons syndrome) with absence seizures consistent with the International League against Epilepsy Revised Classification of Seizures (2017).\n 4.  Absence seizures persisting despite documented trials with at least two standard anti-epileptic treatments.\n 5.  Observation of at least 3 instances of bilateral synchronous symmetrical spike waves of approximately 2.5 - 4 Hz lasting >3 seconds via 24-hr ambulatory EEG (centrally reviewed).\n 6.  On no therapy or taking stable doses of one or more anti-epileptic medication(s) for at least 30 days. If a subject is not on medication, adequate documentation justifying lack of therapy is acceptable. Ketogenic, modified Atkins (MAD), or low glycemic diet with stable carbohydrate ratio for at least 30 days is an acceptable antiepileptic therapy. Vagal nerve stimulation at stable settings, without use of the magnet, is also acceptable.\n 7.  Body weight â‰¥ 45 kg at screening.\n 8.  Subjects with reproductive capability including all males and women of child-bearing potential (WOCBP) must agree to practice continuous abstinence or adequate contraception methods (appropriate double barrier method or oral, patch, implant, or injectable contraception) from as soon as feasible during screening period until at least 30 days after the last dose (i.e., intermittent abstinence based on \"rhythm\", temperature monitoring, or other means of timing is not acceptable). WOCBP include any woman who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, and/or bilateral oophorectomy) or is not post-menopausal. Post-menopausal is defined as amenorrhea â‰¥ 12 consecutive months without another cause, and a documented serum follicle stimulating hormone (FSH) level â‰¥ 35 mIU/mL.\n 9.  Male subjects with a partner of child-bearing potential must be surgically sterilized or be willing to use condoms with spermicide from as soon as feasible during screening period until at least 30 days after the last dose.\n 10. Able and willing to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.\n 11. Approval by the sponsor medical personnel or delegate as to final eligibility for the study.\n\n","\n\n 1.  History of focal epilepsy or epileptiform patterns consistent with focal epilepsy during screening measured by 24-hr ambulatory EEG.\n 2.  History of surgical intervention for treatment of epilepsy.\n 3.  Inadequately treated psychotic or mood disorder (e.g., schizophrenia, major depression, bipolar disorder).\n 4.  Presence of severe intellectual disability, severe autism spectrum disorder or severe developmental disorder.\n 5.  Presence of positive urine drug screen for drugs of abuse, except if this is explained by use of an allowed prescription medicine.\n 6.  Regular use of more than one standard drink of alcohol per day (14 grams of pure alcohol).\n 7.  Hypersensitivity/allergic reaction to other T-type calcium agents, such as (but not limited to) ethosuximide and zonisamide.\n 8.  Use of strong CYP3A4 inhibitors, including prescription or non-prescription drugs or other products (i.e. grapefruit juice), which cannot be discontinued at least 2 weeks prior to Day 1 of dosing and throughout the study (Appendix C).\n 9.  Concurrent illnesses that would be a contraindication to trial participation, including, but not limited to: 1. Severe arterial thromboembolic events (myocardial infarction, unstable angina pectoris, stroke) less than 6 months before screening\n      2. NYHA Class III or IV congestive heart failure, ventricular arrhythmias or uncontrolled hypertension\n      3. Clinically significant ECG abnormality per the Investigator assessment or any of the following: i) QTcF â‰¥450 msec (males) or â‰¥470 msec (females) ii) PR interval â‰¥250 msec iii) Atrioventricular block of second degree or higher, including Mobitz I iv) Persistent sinus bradycardia â‰¤ 50 beats per minute; persistent means the bradycardia is present on the first ECG and on one repeat ECG performed on another day v) For other ECG findings (e.g., including, but not necessarily limited to, tachycardia, bundle branch block, frequent ectopic beats, etc.) the Investigator should send a scanned, identity-blinded copy of the ECG tracing to the Study Safety Representative for review.\n     \n     \n 10. Positive result for HIV, Hepatitis B [indicating ongoing infection], or Hepatitis C at screening or otherwise known ongoing infection with HIV, hepatitis B, or hepatitis C, unless curative therapy completed; for hepatitis C curative therapy is defined as negative PCR for HCV RNA.\n 11. Significant hepatic (AST/ALT or bilirubin â‰¥ 2X upper limit of normal) or renal disease (creatinine clearance â‰¤39 mL/min) at screening.\n 12. History of alcohol or substance abuse within the last year.\n 13. A current C-SSRS score of 4 or 5 at screening or history of suicide attempt at any time during the past year.\n 14. Psychological, social, familial, or geographical reasons that would hinder or prevent compliance with the requirements of the protocol or compromise the informed consent process.\n 15. Any other condition and/or situation that causes the Investigator or Study Safety Representative to deem a subject unsuitable for the study (e.g., due to expected study medication non-compliance, inability to medically tolerate the study procedures, or a subject's unwillingness to comply with study-related procedures).\n 16. Treatment with an investigational agent within 30 days prior to the first dose of CX-8998 or planning to receive an investigational agent during the study.","FSH",null,"Protein","Ovary","Actual","2018-01-23","Actual","Anticipated","2018-11-25","Anticipated","2018-01-01","2018-01-02","2018-01-22","2018-01-22","No","Epilepsy, Generalized Epileptic Syndromes, Absence Seizures","Interventional","Treatment","Parallel Assignment","Double (Participant, Investigator)","Randomized","16 Years","45 Years","All",null,"No","Undecided",{"$nulls":3},"Yes","No",{"$nulls":19},"Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] as assessed by CTCAE v4.0|Changes from baseline in QTcF and other electrocardiogram parameters|Changes from baseline in clinical safety laboratory assessments|Number (%) of subjects who did not complete the study due to Treatment Emergent Adverse Events as assessed by CTCAE v4.0|Number (%) of subjects with Serious Adverse Events as assessed by CTCAE v4.0|Number (%) of subjects with Adverse Events of Special Interest as assessed by CTCAE v4.0|Columbia-Suicide Severity Rating Scale (C-SSRS)","Treatment-emergent adverse events are all adverse events occurring during the treatment period or a pretreatment event that worsens in intensity during the treatment period.|Fridericia's Correction Formula (QTCF) is a formula which takes into account the physiologic shortening of the QT interval which occurs as the heart rate increases, permitting comparison of the QT interval across a range of rates.|Clinical safety laboratory assessments will include chemistry and hematology. Urinalysis to be performed only as clinically indicated. Additional lab tests are obtained at the screening visit to verify eligibility (including HIV, Hepatitis B and C).|Any adverse event that results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect observed in any offspring of the subject conceived during treatment with the study drug or is an important medical event.|An adverse event of special interest is a serious adverse event as defined in Outcome 6. This includes, however is not limited to, increased seizure frequency, new seizure types, worsening of EEG parameters, systemic adverse events based on safety profile|C-SSRS is a suicidal ideation rating scale which identifies behaviors that may be indicative of an individual's intent to commit suicide. The maximum suicidal ideation category (1-5 on the C-SSRS) present at the assessment.","Through study completion, an average of 9 weeks|Baseline through study completion, an average of 5 weeks|Duration of study, an average of 9 weeks|The \"lifetime\" version of the C-SSRS will be used at screening, and the \"since last visit\" version at all other visits. The C-SSRS will be evaluated by the visiting nurse at Day 8 and Day 20",{"$nulls":3},"omara@cavionpharma.com","Ryan O'Mara","1.585.766.2886","Port Charlotte, Florida, United States, 33952|Norcross, Georgia, United States, 30093|Lexington, Kentucky, United States, 40504|Bethesda, Maryland, United States, 20817|New York, New York, United States, 10016|Cincinnati, Ohio, United States, 45229|Philadelphia, Pennsylvania, United States, 19107","Florida|Georgia|Kentucky|Maryland|New York|Ohio|Pennsylvania","United States","Medsol Clinial Research Center, Inc.|Center For Rare Neurological Diseases|Bluegrass Epilepsy Research, Llc|Mid-Atlantic Epilepsy And Sleep Center|Nyu Comprehensive Epilepsy Center|Cincinnati Children's Hospital|Thomas Jefferson University",{"$nulls":3},"Stacey Boyer, PhD","2018-01-22","2020-05-25T16:38:02.257","2020-05-26T17:10:42.972","NCT03406702"]
["5ecbf46ae2561b1b11905df6","NCT03406702","2018-11-21","Jazz","JAZZ","Recruiting","A Phase 2 Study of CX-8998 in Adolescents and Adults With Idiopathic Generalized Epilepsy With Absence Seizures (T-WAVE)","Cx-8998",null,"Yes","['Cx-8998']","Unknown",null,"Phase 2",1,15,"Anticipated","2018-02-25","2019-01-25","ESS","Epworth Sleepiness Scale",{"$nulls":3},"This is a Phase 2a, open-label study consisting of a screening period of up to 4 weeks and a 4-dose-titration treatment period to a dose of up to 10 mg twice daily (BID) of CX-8998, followed by a 1-week safety follow-up period after the last dose of study medication.","This is a Phase 2a, open-label study consisting of a screening period of up to 4 weeks and a 4-dose-titration treatment period to a dose of up to 10 mg twice daily (BID) of CX-8998, followed by a 1-week safety follow-up period after the last dose of study medication.\n\nSubjects will participate for a total of up to 9 weeks, including screening, the 4-week treatment period and follow-up.","A Phase 2a, Safety, Tolerability, Pharmacokinetics, and Quantitative EEG Study of CX-8998 in Adolescents and Adults With Idiopathic Generalized Epilepsy With Absence Seizures","CX-8998-CLN2-002","Epilepsy","Epilepsy","Central Nervous System Diseases","Central Nervous System","Experimental","CX-8998","T-type calcium channel blocker","Drug","CX-8998","T-type calcium channel blocker",null,"CX-8998","\n\n 1.  Signed informed consent form (ICF) indicating that the subject has been informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential benefits, side effects, risks, and discomforts.\n 2.  Men or non-pregnant, non-breastfeeding women 16 to 55 years-of-age who are able to read and understand written and spoken local language.\n 3.  Clinical diagnosis of IGE (including, but not limited to, CAE, JAE, juvenile myoclonic epilepsy, or Jeavons syndrome) with absence seizures consistent with the International League against Epilepsy Revised Classification of Seizures (2017).\n 4.  Absence seizures persisting despite standard of care (SOC) treatment, defined as treatment with at least 2 AEDs appropriate for the patient's epilepsy syndrome. SOC failure, per investigator discretion, will be defined as insufficient clinical response or intolerable side effects, which precludes use of the appropriate AED.\n 5.  Observation of at least 3 instances of generalized discharges of approximately 2.5 - 4 Hz lasting â‰¥2 seconds via 24-hour ambulatory EEG (centrally reviewed), with approximately 75% normal background based on age and medication use per the central EEG reader's discretion. Intermittent focal spikes are allowed.\n 6.  On stable doses of one or more antiepileptic medication(s) for at least 30 days. If a subject is not on medication, adequate documentation justifying lack of therapy may be acceptable for the subject after sponsor review. Ketogenic, modified Atkins diet (MAD), or low glycemic diet with stable carbohydrate ratio for at least 30 days before screening is an acceptable antiepileptic therapy. Vagal nerve stimulation at stable settings (for at least 30 days before screening), without use of the magnet, is also acceptable.\n 7.  Body weight â‰¥ 45 kg at screening.\n 8.  Subjects with reproductive capability including all males and women of child-bearing potential (WOCBP) must agree to practice continuous abstinence or adequate contraception methods (appropriate double barrier method or oral, patch, implant, or injectable contraception) from as soon as feasible during screening period until at least 30 days after the last dose (i.e., intermittent abstinence based on \"rhythm\", temperature monitoring, or other means of timing is not acceptable). WOCBP include any woman who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, and/or bilateral oophorectomy) or is not post-menopausal. Post-menopausal is defined as amenorrhea â‰¥ 12 consecutive months without another cause, and a documented serum follicle stimulating hormone (FSH) level â‰¥ 35 mIU/mL.\n 9.  Male subjects with a partner of child-bearing potential must be surgically sterilized or be willing to use condoms with spermicide from as soon as feasible during screening period until at least 30 days after the last dose.\n 10. Able and willing to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.\n 11. Approval by the sponsor medical personnel or delegate as to final eligibility for the study.\n\n","\n\n 1.  History of surgical intervention for treatment of epilepsy.\n 2.  Additional seizure (clinical and electrographic) types, including, but not limited to, epileptic spasms, generalized tonic seizures, atonic seizures, or focal seizures. Subjects with GTCS or myoclonic seizures are eligible for the study.\n 3.  Inadequately treated psychotic or mood disorder (e.g., schizophrenia, major depression, bipolar disorder).\n 4.  Presence of severe intellectual disability, severe autism spectrum disorder, or severe developmental disorder such that the subject cannot sign the ICF or cannot cooperate with the study procedures.\n 5.  Presence of positive urine drug screen for drugs of abuse, except if this is explained by use of an allowed prescription medicine.\n 6.  Regular use of more than 2 standard drinks of alcohol per day (28 grams of pure alcohol).\n 7.  Hypersensitivity/allergic reaction to other T-type calcium agents, such as (but not limited to) ethosuximide and zonisamide.\n 8.  Use of strong CYP3A4 inhibitors, including prescription or non-prescription drugs or other products (i.e. grapefruit juice), which cannot be discontinued at least 2 weeks prior to Day 1 of dosing and throughout the study (Appendix C).\n 9.  Concurrent illnesses that would be a contraindication to trial participation, including, but not limited to: 1. Severe arterial thromboembolic events (myocardial infarction, unstable angina pectoris, stroke) less than 6 months before screening\n      2. NYHA Class III or IV congestive heart failure, ventricular arrhythmias or uncontrolled hypertension\n      3. Clinically significant ECG abnormality per the Investigator assessment or any of the following: i) QTcF â‰¥450 msec (males) or â‰¥470 msec (females) ii) PR interval â‰¥250 msec iii) Atrioventricular block of second degree or higher, including Mobitz I iv) Persistent sinus bradycardia â‰¤ 50 beats per minute; persistent means the bradycardia is present on the first ECG and on one repeat ECG performed on another day v) For other ECG findings (e.g., including, but not necessarily limited to, tachycardia, bundle branch block, frequent ectopic beats, etc.) the Investigator should send a scanned, identity-blinded copy of the ECG tracing to the Study Safety Representative for review.\n     \n     \n 10. Positive result for HIV, Hepatitis B [indicating ongoing infection], or Hepatitis C at screening or otherwise known ongoing infection with HIV, hepatitis B, or hepatitis C, unless curative therapy completed; for hepatitis C curative therapy is defined as negative PCR for HCV RNA.\n 11. Significant hepatic (AST/ALT or bilirubin â‰¥ 2X upper limit of normal) or renal disease (creatinine clearance â‰¤39 mL/min) at screening.\n 12. History of alcohol or substance abuse within the last year.\n 13. A current C-SSRS score of 4 or 5 at screening or history of suicide attempt.\n 14. Psychological, social, familial, or geographical reasons that would hinder or prevent compliance with the requirements of the protocol or compromise the informed consent process.\n 15. Any other condition and/or situation that causes the Investigator or Study Safety Representative to deem a subject unsuitable for the study (including, but not limited to, expected study medication non-compliance, inability to medically tolerate the study procedures, or a subject's unwillingness to comply with study-related procedures).\n 16. Treatment with an investigational agent within 30 days prior to the first dose of CX-8998 or planning to receive an investigational agent during the study.","FSH",null,"Protein","Ovary","Actual","2018-01-23","Actual","Anticipated","2019-03-25","Anticipated","2018-11-01","2018-01-02","2018-01-22","2018-11-19","No","Epilepsy, Idiopathic Generalized Epilepsy, Absence Seizures","Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","16 Years","55 Years","All",null,"No","Undecided",{"$nulls":3},"Yes","No",{"$nulls":19},"Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] as assessed by CTCAE v4.0|Changes from baseline in QTcF and other electrocardiogram parameters|Changes from baseline in clinical safety laboratory assessments|Number (%) of subjects who did not complete the study due to Treatment Emergent Adverse Events as assessed by CTCAE v4.0|Number (%) of subjects with Serious Adverse Events as assessed by CTCAE v4.0|Number (%) of subjects with Adverse Events of Special Interest as assessed by CTCAE v4.0|Columbia-Suicide Severity Rating Scale (C-SSRS)|Epworth Sleepiness Scale (ESS)|University of Miami Parkinson's Disease Hallucinations Questionnaire (UM-PDHQ)","Treatment-emergent adverse events are all adverse events occurring during the treatment period or a pretreatment event that worsens in intensity during the treatment period.|Fridericia's Correction Formula (QTCF) is a formula which takes into account the physiologic shortening of the QT interval which occurs as the heart rate increases, permitting comparison of the QT interval across a range of rates.|Clinical safety laboratory assessments will include chemistry and hematology. Urinalysis to be performed only as clinically indicated. Additional lab tests are obtained at the screening visit to verify eligibility (including HIV, Hepatitis B and C).|Any adverse event that results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect observed in any offspring of the subject conceived during treatment with the study drug or is an important medical event.|An adverse event of special interest is a serious adverse event as defined in Outcome 6. This includes, however is not limited to, increased seizure frequency, new seizure types, worsening of EEG parameters, systemic adverse events based on safety profile|C-SSRS is a suicidal ideation rating scale which identifies behaviors that may be indicative of an individual's intent to commit suicide. The maximum suicidal ideation category (1-5 on the C-SSRS) present at the assessment.|The ESS is a scale intended to measure daytime sleepiness that is measured by use of a very short questionnaire asks the subject to rate his or her probability of falling asleep on a scale of increasing probability from 0 to 3 for 8 different situations. The scores are added together to obtain a single number.|The UM-PDHQ is a 20-item clinician-administered questionnaire that quantitatively and qualitatively assesses hallucinations. The UM-PDHQ will be completed for any subject who reports hallucinations","Through study completion, an average of 9 weeks|Baseline through study completion, an average of 5 weeks|Duration of study, an average of 9 weeks|The \"lifetime\" version of the C-SSRS will be used at screening, and the \"since last visit\" version at all other visits. The C-SSRS will be evaluated by the visiting nurse at Day 8 and Day 20",{"$nulls":3},"omara@cavionpharma.com","Ryan O'Mara","1.585.766.2886","Tampa, Florida, United States, 33612|Lexington, Kentucky, United States, 40504|Boston, Massachusetts, United States, 02111|New York, New York, United States, 10016|Cincinnati, Ohio, United States, 45229|Philadelphia, Pennsylvania, United States, 19107","Florida|Kentucky|Massachusetts|New York|Ohio|Pennsylvania","United States","University Of Florida|Bluegrass Epilepsy Research, Llc|Tufts Medical Center|Nyu Comprehensive Epilepsy Center|Cincinnati Children's Hospital|Thomas Jefferson University",{"$nulls":3},"Stacey Boyer, PhD","2018-11-19","2020-05-25T16:38:02.060","2020-05-26T17:10:42.972","NCT03406702"]
["5ecbf46ae2561b1b11905df8","NCT03406702","2020-04-03","Jazz","JAZZ","Completed","A Phase 2 Study of CX-8998 in Adolescents and Adults With Idiopathic Generalized Epilepsy With Absence Seizures (T-WAVE)","Cx-8998",null,"Yes","['Cx-8998']","Unknown",null,"Phase 2",1,15,"Actual","2018-02-25","2019-03-29","ESS","Epworth Sleepiness Scale",{"$nulls":3},"This is a Phase 2a, open-label study consisting of a screening period of up to 4 weeks and a 4-dose-titration treatment period to a dose of up to 10 mg twice daily (BID) of CX-8998, followed by a 1-week safety follow-up period after the last dose of study medication.","This is a Phase 2a, open-label study consisting of a screening period of up to 4 weeks and a 4-dose-titration treatment period to a dose of up to 10 mg twice daily (BID) of CX-8998, followed by a 1-week safety follow-up period after the last dose of study medication.\n\nSubjects will participate for a total of up to 9 weeks, including screening, the 4-week treatment period and follow-up.","A Phase 2a, Safety, Tolerability, Pharmacokinetics, and Quantitative EEG Study of CX-8998 in Adolescents and Adults With Idiopathic Generalized Epilepsy With Absence Seizures","CX-8998-CLN2-002","Epilepsy","Epilepsy","Central Nervous System Diseases","Central Nervous System","Experimental","CX-8998","T-type calcium channel blocker","Drug","CX-8998","T-type calcium channel blocker",null,"CX-8998","\n\n 1.  Signed informed consent form (ICF) indicating that the subject has been informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential benefits, side effects, risks, and discomforts.\n 2.  Men or non-pregnant, non-breastfeeding women 16 to 55 years-of-age who are able to read and understand written and spoken local language.\n 3.  Clinical diagnosis of IGE (including, but not limited to, CAE, JAE, juvenile myoclonic epilepsy, or Jeavons syndrome) with absence seizures consistent with the International League against Epilepsy Revised Classification of Seizures (2017).\n 4.  Absence seizures persisting despite standard of care (SOC) treatment, defined as treatment with at least 2 AEDs appropriate for the patient's epilepsy syndrome. SOC failure, per investigator discretion, will be defined as insufficient clinical response or intolerable side effects, which precludes use of the appropriate AED.\n 5.  Observation of at least 3 instances of generalized discharges of approximately 2.5 - 4 Hz lasting â‰¥2 seconds via 24-hour ambulatory EEG (centrally reviewed), with approximately 75% normal background based on age and medication use per the central EEG reader's discretion. Intermittent focal spikes are allowed.\n 6.  On stable doses of one or more antiepileptic medication(s) for at least 30 days. If a subject is not on medication, adequate documentation justifying lack of therapy may be acceptable for the subject after sponsor review. Ketogenic, modified Atkins diet (MAD), or low glycemic diet with stable carbohydrate ratio for at least 30 days before screening is an acceptable antiepileptic therapy. Vagal nerve stimulation at stable settings (for at least 30 days before screening), without use of the magnet, is also acceptable.\n 7.  Body weight â‰¥ 45 kg at screening.\n 8.  Subjects with reproductive capability including all males and women of child-bearing potential (WOCBP) must agree to practice continuous abstinence or adequate contraception methods (appropriate double barrier method or oral, patch, implant, or injectable contraception) from as soon as feasible during screening period until at least 30 days after the last dose (i.e., intermittent abstinence based on \"rhythm\", temperature monitoring, or other means of timing is not acceptable). WOCBP include any woman who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, and/or bilateral oophorectomy) or is not post-menopausal. Post-menopausal is defined as amenorrhea â‰¥ 12 consecutive months without another cause, and a documented serum follicle stimulating hormone (FSH) level â‰¥ 35 mIU/mL.\n 9.  Male subjects with a partner of child-bearing potential must be surgically sterilized or be willing to use condoms with spermicide from as soon as feasible during screening period until at least 30 days after the last dose.\n 10. Able and willing to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.\n 11. Approval by the sponsor medical personnel or delegate as to final eligibility for the study.\n\n","\n\n 1.  History of surgical intervention for treatment of epilepsy.\n 2.  Additional seizure (clinical and electrographic) types, including, but not limited to, epileptic spasms, generalized tonic seizures, atonic seizures, or focal seizures. Subjects with GTCS or myoclonic seizures are eligible for the study.\n 3.  Inadequately treated psychotic or mood disorder (e.g., schizophrenia, major depression, bipolar disorder).\n 4.  Presence of severe intellectual disability, severe autism spectrum disorder, or severe developmental disorder such that the subject cannot sign the ICF or cannot cooperate with the study procedures.\n 5.  Presence of positive urine drug screen for drugs of abuse, except if this is explained by use of an allowed prescription medicine.\n 6.  Regular use of more than 2 standard drinks of alcohol per day (28 grams of pure alcohol).\n 7.  Hypersensitivity/allergic reaction to other T-type calcium agents, such as (but not limited to) ethosuximide and zonisamide.\n 8.  Use of strong CYP3A4 inhibitors, including prescription or non-prescription drugs or other products (i.e. grapefruit juice), which cannot be discontinued at least 2 weeks prior to Day 1 of dosing and throughout the study (Appendix C).\n 9.  Concurrent illnesses that would be a contraindication to trial participation, including, but not limited to: 1. Severe arterial thromboembolic events (myocardial infarction, unstable angina pectoris, stroke) less than 6 months before screening\n      2. NYHA Class III or IV congestive heart failure, ventricular arrhythmias or uncontrolled hypertension\n      3. Clinically significant ECG abnormality per the Investigator assessment or any of the following: i) QTcF â‰¥450 msec (males) or â‰¥470 msec (females) ii) PR interval â‰¥250 msec iii) Atrioventricular block of second degree or higher, including Mobitz I iv) Persistent sinus bradycardia â‰¤ 50 beats per minute; persistent means the bradycardia is present on the first ECG and on one repeat ECG performed on another day v) For other ECG findings (e.g., including, but not necessarily limited to, tachycardia, bundle branch block, frequent ectopic beats, etc.) the Investigator should send a scanned, identity-blinded copy of the ECG tracing to the Study Safety Representative for review.\n     \n     \n 10. Positive result for HIV, Hepatitis B [indicating ongoing infection], or Hepatitis C at screening or otherwise known ongoing infection with HIV, hepatitis B, or hepatitis C, unless curative therapy completed; for hepatitis C curative therapy is defined as negative PCR for HCV RNA.\n 11. Significant hepatic (AST/ALT or bilirubin â‰¥ 2X upper limit of normal) or renal disease (creatinine clearance â‰¤39 mL/min) at screening.\n 12. History of alcohol or substance abuse within the last year.\n 13. A current C-SSRS score of 4 or 5 at screening or history of suicide attempt.\n 14. Psychological, social, familial, or geographical reasons that would hinder or prevent compliance with the requirements of the protocol or compromise the informed consent process.\n 15. Any other condition and/or situation that causes the Investigator or Study Safety Representative to deem a subject unsuitable for the study (including, but not limited to, expected study medication non-compliance, inability to medically tolerate the study procedures, or a subject's unwillingness to comply with study-related procedures).\n 16. Treatment with an investigational agent within 30 days prior to the first dose of CX-8998 or planning to receive an investigational agent during the study.","FSH",null,"Protein","Ovary","Actual","2018-01-23","Actual","Actual","2019-03-29","Actual","2020-03-01","2018-01-02","2018-01-22","2020-03-29","No","Epilepsy, Idiopathic Generalized Epilepsy, Absence Seizures","Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","16 Years","55 Years","All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":7},43919,43919,"April 3, 2020 [Actual]",{"$nulls":9},"Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] as assessed by CTCAE v4.0|Changes from baseline in QTcF and other electrocardiogram parameters|Changes from baseline in clinical safety laboratory assessments|Number (%) of subjects who did not complete the study due to Treatment Emergent Adverse Events as assessed by CTCAE v4.0|Number (%) of subjects with Serious Adverse Events as assessed by CTCAE v4.0|Number (%) of subjects with Adverse Events of Special Interest as assessed by CTCAE v4.0|Columbia-Suicide Severity Rating Scale (C-SSRS)|Epworth Sleepiness Scale (ESS)|University of Miami Parkinson's Disease Hallucinations Questionnaire (UM-PDHQ)","Treatment-emergent adverse events are all adverse events occurring during the treatment period or a pretreatment event that worsens in intensity during the treatment period.|Fridericia's Correction Formula (QTCF) is a formula which takes into account the physiologic shortening of the QT interval which occurs as the heart rate increases, permitting comparison of the QT interval across a range of rates.|Clinical safety laboratory assessments will include chemistry and hematology. Urinalysis to be performed only as clinically indicated. Additional lab tests are obtained at the screening visit to verify eligibility (including HIV, Hepatitis B and C).|Any adverse event that results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect observed in any offspring of the subject conceived during treatment with the study drug or is an important medical event.|An adverse event of special interest is a serious adverse event as defined in Outcome 6. This includes, however is not limited to, increased seizure frequency, new seizure types, worsening of EEG parameters, systemic adverse events based on safety profile|C-SSRS is a suicidal ideation rating scale which identifies behaviors that may be indicative of an individual's intent to commit suicide. The maximum suicidal ideation category (1-5 on the C-SSRS) present at the assessment.|The ESS is a scale intended to measure daytime sleepiness that is measured by use of a very short questionnaire asks the subject to rate his or her probability of falling asleep on a scale of increasing probability from 0 to 3 for 8 different situations. The scores are added together to obtain a single number.|The UM-PDHQ is a 20-item clinician-administered questionnaire that quantitatively and qualitatively assesses hallucinations. The UM-PDHQ will be completed for any subject who reports hallucinations","Through study completion, an average of 9 weeks|Baseline through study completion, an average of 5 weeks|Duration of study, an average of 9 weeks|The \"lifetime\" version of the C-SSRS will be used at screening, and the \"since last visit\" version at all other visits. The C-SSRS will be evaluated by the visiting nurse at Day 8 and Day 20",{"$nulls":6},"Little Rock, Arkansas, United States, 72205|Tampa, Florida, United States, 33612|Lexington, Kentucky, United States, 40504|Boston, Massachusetts, United States, 02111|New York, New York, United States, 10016|Cincinnati, Ohio, United States, 45229|Philadelphia, Pennsylvania, United States, 19107","Arkansas|Florida|Kentucky|Massachusetts|New York|Ohio|Pennsylvania","United States","Arkansas Epilepsy Program|University Of Florida|Bluegrass Epilepsy Research, Llc|Tufts Medical Center|Nyu Comprehensive Epilepsy Center|Cincinnati Children's Hospital|Thomas Jefferson University",{"$nulls":4},"2020-03-29","2020-05-25T16:38:02.634","2020-05-26T17:10:42.972","NCT03406702"]
["5ecbf46a307e3d1b1f8d9d8e","NCT03406780","2018-02-15","Capricor","CAPR","Not yet recruiting","A Study of CAP-1002 in Ambulatory and Non-Ambulatory Patients With Duchenne Muscular Dystrophy (HOPE-2)","Cap-1002","Immunomodulator|Apoptosis Inhibitor","Yes","['Cap-1002']","No",null,"Phase 2",2,84,"Anticipated","2018-03-01","2019-12-01",{"$nulls":5},"HOPE-2 is a double-blind clinical trial evaluating the safety and efficacy of a cell therapy called CAP-1002 in study participants with Duchenne muscular dystrophy (DMD). Non-ambulatory and ambulatory boys and young men who meet eligibility criteria will be randomly assigned to receive either CAP-1002 or placebo every 3 months for a total of 4 doses during a 12-month period.","* Approximately 84 eligible study participants will be randomized to either CAP-1002 or placebo in a 1:1 ratio.\n * The trial will include visits at Screening, Baseline/Day 1, Week 4, and Months 3, 6, 9, and 12 with IV infusions of CAP-1002 or placebo on Day 1 and Months 3, 6, and 9.\n * Safety evaluations will include adverse events, concomitant medications, physical exam, vital signs, 12-lead ECG, and clinical laboratory testing.\n * Efficacy will be evaluated in the Performance of the Upper Limb, pulmonary function testing, North Star Ambulatory Assessment (ambulatory subjects only), grip and pinch strength, cardiac MRI, and quality of life.\n * If trial data suggests an appropriate risk/benefit profile of CAP-1002, Capricor, upon the recommendation of the Data Safety Monitoring Board (DSMB), will introduce an open-label extension study to offer CAP-1002 to study participants who were randomized to placebo and completed all trial visits during the 12-month period.","A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of Intravenous Delivery of Allogeneic Cardiosphere-Derived Cells in Subjects With Duchenne Muscular Dystrophy","CAP-1002-DMD-02","Muscular Dystrophies\nMuscular Dystrophy, Duchenne\nMuscular Disorders, Atrophic\nMuscular Diseases\nNeuromuscular Diseases\nNervous System Diseases\nGenetic Diseases, X-Linked\nGenetic Diseases, Inborn","Muscular Dystrophy, Duchenne|Muscular Disorders, Atrophic|Muscular Dystrophies|Genetic Diseases, X-Linked","Muscular Diseases|Genetic Diseases, Inborn","Musculoskeletal|Neonatal Diseases & Abnormalities","Experimental|Placebo Comparator","CAP-1002|Placebo","Patients will receive 150 million cardiosphere-derived cells (CDCs) via intravenous infusion every 3 months for a total of 4 doses.|Patients will receive a placebo solution via intravenous infusion every 3 months for a total of 4 doses.","Biological|Drug","CAP-1002|Placebo","The active pharmaceutical ingredient in CAP-1002 is Cardiosphere-Derived Cells (CDCs). CDCs are known to secrete numerous bioactive elements (growth factors, exosomes) which impact the therapeutic benefits of the cell-based therapy. The mechanism of action is the composite ability to be immunomodulatory, anti-fibrotic and regenerative.|Placebo","Cardiosphere-Derived Cells | CDCs","CAP-1002|Placebo","\n\n 1. Genetically confirmed DMD\n 2. Reduced upper arm strength as measured by the Performance of Upper Limb\n 3. Reduced ability to walk/run (if ambulatory)\n 4. Percent-predicted forced vital capacity (FVC) â‰¥ 30% and â‰¤ 80%\n 5. Treatment with systemic glucocorticoids for at least 12 months and at a stable dose at least 6 months prior to study participation, except for weight-based or toxicity-related adjustments\n\n","\n\n 1.  Left ventricular ejection fraction < 35%\n 2.  BMI > 45\n 3.  Ambulant if â‰¥ 18 years of age\n 4.  Exon 44 skip-amenable mutation(s) in the DMD gene\n 5.  Deletion mutation(s) encompassing exons 3-7 of the DMD gene\n 6.  Chronic respiratory disease not related to DMD (for example, asthma, bronchitis, and tuberculosis)\n 7.  History of diabetes requiring treatment with metformin or insulin within 3 months prior to randomization\n 8.  Treatment with an FDA-approved exon skipping therapy for the treatment of DMD if on a stable dose for less than 24 months prior to randomization\n 9.  Treatment with human growth hormone (HGH) within 3 months prior to randomization, unless on a stable dose for at least 24 months prior to randomization\n 10. Treatment with idebenone within 3 months prior to randomization\n 11. Treatment with a cell therapy product within 12 months prior to randomization\n 12. Treatment with an investigational product within 6 months prior to randomization",{"$nulls":4},"Actual","2018-01-23","Actual","Anticipated","2020-03-01","Anticipated","2018-02-01","2018-01-15","2018-01-19","2018-02-13","Yes","Duchenne Muscular Dystrophy\nCell Therapy\nPerformance of the Upper Limb\nPulmonary Function\nAmbulatory\nNon-Ambulatory\nGlucocorticoids","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","10 Years",null,"Male",null,"No","Undecided",null,"URL: http://capricor.com [http://capricor.com] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: Company website",null,"Yes","No",{"$nulls":19},"Change in the mid-level (elbow) dimension of the Performance of the Upper Limb (PUL)","The PUL includes functional tasks that relate to activities of daily living that are very important for quality of life. The PUL has been validated for the assessment of upper limb motor function in individuals with DMD.","Month 12","Change in the mid-level (elbow) dimension of the PUL|Change in regional systolic left ventricular wall thickening as assessed by cardiac MRI","The PUL includes functional tasks that relate to activities of daily living that are very important for quality of life. The PUL has been validated for the assessment of upper limb motor function in individuals with DMD.|Systolic thickening is thought to be a principal mechanism of cardiac output generation in people with DMD.","Months 3, 6, and 9|Months 6 and 12","HOPE-2@capricor.com","Brian Fedor","310-358-3201",{"$nulls":7},"Deborah D Ascheim, MD","2018-02-13","2020-05-25T16:38:02.685","2020-05-26T17:10:42.972","NCT03406780"]
["5ecbf46a11702c1b1b916b0c","NCT03406780","2018-06-04","Capricor","CAPR","Recruiting","A Study of CAP-1002 in Ambulatory and Non-Ambulatory Patients With Duchenne Muscular Dystrophy (HOPE-2)","Cap-1002","Immunomodulator|Apoptosis Inhibitor","Yes","['Cap-1002']","No",null,"Phase 2",2,84,"Anticipated","2018-04-04","2019-12-01",{"$nulls":5},"HOPE-2 is a double-blind clinical trial evaluating the safety and efficacy of a cell therapy called CAP-1002 in study participants with Duchenne muscular dystrophy (DMD). Non-ambulatory and ambulatory boys and young men who meet eligibility criteria will be randomly assigned to receive either CAP-1002 or placebo every 3 months for a total of 4 doses during a 12-month period.","* Approximately 84 eligible study participants will be randomized to either CAP-1002 or placebo in a 1:1 ratio.\n * The trial will include visits at Screening, Baseline/Day 1, Week 4, and Months 3, 6, 9, and 12 with IV infusions of CAP-1002 or placebo on Day 1 and Months 3, 6, and 9.\n * Safety evaluations will include adverse events, concomitant medications, physical exam, vital signs, 12-lead ECG, and clinical laboratory testing.\n * Efficacy will be evaluated in the Performance of the Upper Limb, pulmonary function testing, North Star Ambulatory Assessment (ambulatory subjects only), strength testing, cardiac MRI, and quality of life.\n * If trial data suggests an appropriate risk/benefit profile of CAP-1002, Capricor, upon the recommendation of the Data Safety Monitoring Board (DSMB), will introduce an open-label extension study to offer CAP-1002 to study participants who were randomized to placebo and completed all trial visits during the 12-month period.","A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of Intravenous Delivery of Allogeneic Cardiosphere-Derived Cells in Subjects With Duchenne Muscular Dystrophy","CAP-1002-DMD-02","Muscular Dystrophies\nMuscular Dystrophy, Duchenne\nMuscular Disorders, Atrophic\nMuscular Diseases\nNeuromuscular Diseases\nNervous System Diseases\nGenetic Diseases, X-Linked\nGenetic Diseases, Inborn","Muscular Dystrophy, Duchenne|Muscular Disorders, Atrophic|Muscular Dystrophies|Genetic Diseases, X-Linked","Muscular Diseases|Genetic Diseases, Inborn","Musculoskeletal|Neonatal Diseases & Abnormalities","Experimental|Placebo Comparator","CAP-1002|Placebo","Patients will receive 150 million cardiosphere-derived cells (CDCs) via intravenous infusion every 3 months for a total of 4 doses.|Patients will receive a placebo solution via intravenous infusion every 3 months for a total of 4 doses.","Biological|Drug","CAP-1002|Placebo","The active pharmaceutical ingredient in CAP-1002 is Cardiosphere-Derived Cells (CDCs). CDCs are known to secrete numerous bioactive elements (growth factors, exosomes) which impact the therapeutic benefits of the cell-based therapy. The mechanism of action is the composite ability to be immunomodulatory, anti-fibrotic and regenerative.|Placebo","Cardiosphere-Derived Cells | CDCs","CAP-1002|Placebo","\n\n 1. Genetically confirmed DMD\n 2. Reduced upper arm strength as measured by the Performance of Upper Limb\n 3. Reduced ability to walk/run (if ambulatory)\n 4. Treatment with systemic glucocorticoids for at least 12 months and at a stable dose at least 6 months prior to study participation, except for weight-based or toxicity-related adjustments\n 5. Current and up-to-date immunizations\n\n","\n\n 1.  Left ventricular ejection fraction < 35%\n 2.  BMI > 45\n 3.  Ambulant if â‰¥ 18 years of age\n 4.  Exon 44 skip-amenable mutation(s) in the DMD gene\n 5.  Deletion mutation(s) encompassing exons 3-7 of the DMD gene\n 6.  Percent-predicted forced vital capacity (FVC) < 35%\n 7.  Chronic respiratory disease not related to DMD (for example, asthma, bronchitis, and tuberculosis)\n 8.  History of diabetes requiring treatment with metformin or insulin within 3 months prior to randomization\n 9.  Treatment with an FDA-approved exon skipping therapy for the treatment of DMD if on a stable dose for less than 24 months prior to randomization\n 10. Treatment with human growth hormone (HGH) within 3 months prior to randomization, unless on a stable dose for at least 24 months prior to randomization\n 11. Treatment with idebenone within 3 months prior to randomization\n 12. Treatment with a cell therapy product within 12 months prior to randomization\n 13. Treatment with an investigational product within 6 months prior to randomization",{"$nulls":4},"Actual","2018-01-23","Actual","Anticipated","2020-04-01","Anticipated","2018-04-01","2018-01-15","2018-01-19","2018-05-31","Yes","Duchenne Muscular Dystrophy\nCell Therapy\nPerformance of the Upper Limb\nPulmonary Function\nAmbulatory\nNon-Ambulatory\nGlucocorticoids","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","10 Years",null,"Male",null,"No","Undecided",null,"URL: http://capricor.com [http://capricor.com] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: Company website",null,"Yes","No",{"$nulls":19},"Change in the mid-level (elbow) dimension of the Performance of the Upper Limb (PUL)","The PUL includes functional tasks that relate to activities of daily living that are very important for quality of life. The PUL has been validated for the assessment of upper limb motor function in individuals with DMD.","Month 12","Change in the mid-level (elbow) dimension of the PUL|Change in regional systolic left ventricular wall thickening as assessed by cardiac MRI","The PUL includes functional tasks that relate to activities of daily living that are very important for quality of life. The PUL has been validated for the assessment of upper limb motor function in individuals with DMD.|Systolic thickening is thought to be a principal mechanism of cardiac output generation in people with DMD.","Months 3, 6, and 9|Months 6 and 12","HOPE-2@capricor.com","Brian Fedor","310-358-3201","Sacramento, California, United States, 95817|Salt Lake City, Utah, United States, 84112","California|Utah","United States","University Of California, Davis|University Of Utah",{"$nulls":3},"Deborah D Ascheim, MD","2018-05-31","2020-05-25T16:38:02.765","2020-05-26T17:10:42.972","NCT03406780"]
["5ecbf46afe30261b1a0482fe","NCT03406780","2018-07-30","Capricor","CAPR","Recruiting","A Study of CAP-1002 in Ambulatory and Non-Ambulatory Patients With Duchenne Muscular Dystrophy (HOPE-2)","Cap-1002","Immunomodulator|Apoptosis Inhibitor","Yes","['Cap-1002']","No",null,"Phase 2",2,84,"Anticipated","2018-04-04","2019-12-01",{"$nulls":5},"HOPE-2 is a double-blind clinical trial evaluating the safety and efficacy of a cell therapy called CAP-1002 in study participants with Duchenne muscular dystrophy (DMD). Non-ambulatory and ambulatory boys and young men who meet eligibility criteria will be randomly assigned to receive either CAP-1002 or placebo every 3 months for a total of 4 doses during a 12-month period.","* Approximately 84 eligible study participants will be randomized to either CAP-1002 or placebo in a 1:1 ratio.\n * The trial will include visits at Screening, Baseline/Day 1, Week 4, and Months 3, 6, 9, and 12 with IV infusions of CAP-1002 or placebo on Day 1 and Months 3, 6, and 9.\n * Safety evaluations will include adverse events, concomitant medications, physical exam, vital signs, 12-lead ECG, and clinical laboratory testing.\n * Efficacy will be evaluated in the Performance of the Upper Limb, pulmonary function testing, North Star Ambulatory Assessment (ambulatory subjects only), strength testing, cardiac MRI, and quality of life.\n * If trial data suggests an appropriate risk/benefit profile of CAP-1002, Capricor, upon the recommendation of the Data Safety Monitoring Board (DSMB), will introduce an open-label extension study to offer CAP-1002 to study participants who were randomized to placebo and completed all trial visits during the 12-month period.","A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of Intravenous Delivery of Allogeneic Cardiosphere-Derived Cells in Subjects With Duchenne Muscular Dystrophy","CAP-1002-DMD-02","Muscular Dystrophies\nMuscular Dystrophy, Duchenne\nMuscular Disorders, Atrophic\nMuscular Diseases\nNeuromuscular Diseases\nNervous System Diseases\nGenetic Diseases, X-Linked\nGenetic Diseases, Inborn","Muscular Dystrophy, Duchenne|Muscular Disorders, Atrophic|Muscular Dystrophies|Genetic Diseases, X-Linked","Muscular Diseases|Genetic Diseases, Inborn","Musculoskeletal|Neonatal Diseases & Abnormalities","Experimental|Placebo Comparator","CAP-1002|Placebo","Patients will receive 150 million cardiosphere-derived cells (CDCs) via intravenous infusion every 3 months for a total of 4 doses.|Patients will receive a placebo solution via intravenous infusion every 3 months for a total of 4 doses.","Biological|Drug","CAP-1002|Placebo","The active pharmaceutical ingredient in CAP-1002 is Cardiosphere-Derived Cells (CDCs). CDCs are known to secrete numerous bioactive elements (growth factors, exosomes) which impact the therapeutic benefits of the cell-based therapy. The mechanism of action is the composite ability to be immunomodulatory, anti-fibrotic and regenerative.|Placebo","Cardiosphere-Derived Cells | CDCs","CAP-1002|Placebo","\n\n 1. Genetically confirmed DMD\n 2. Reduced upper arm strength as measured by the Performance of Upper Limb\n 3. Reduced ability to walk/run (if ambulatory)\n 4. Treatment with systemic glucocorticoids for at least 12 months and at a stable dose at least 6 months prior to study participation, except for weight-based or toxicity-related adjustments\n 5. Current and up-to-date immunizations\n\n","\n\n 1.  Left ventricular ejection fraction < 35%\n 2.  BMI > 45\n 3.  Ambulant if â‰¥ 18 years of age\n 4.  Exon 44 skip-amenable mutation(s) in the DMD gene\n 5.  Deletion mutation(s) encompassing exons 3-7 of the DMD gene\n 6.  Percent-predicted forced vital capacity (FVC) < 35%\n 7.  Chronic respiratory disease not related to DMD (for example, asthma, bronchitis, and tuberculosis)\n 8.  History of diabetes requiring treatment with metformin or insulin within 3 months prior to randomization\n 9.  Treatment with an FDA-approved exon skipping therapy for the treatment of DMD if on a stable dose for less than 24 months prior to randomization\n 10. Treatment with human growth hormone (HGH) within 3 months prior to randomization, unless on a stable dose for at least 24 months prior to randomization\n 11. Treatment with idebenone within 3 months prior to randomization\n 12. Treatment with a cell therapy product within 12 months prior to randomization\n 13. Treatment with an investigational product within 6 months prior to randomization",{"$nulls":4},"Actual","2018-01-23","Actual","Anticipated","2020-04-01","Anticipated","2018-06-01","2018-01-15","2018-01-19","2018-07-27","Yes","Duchenne Muscular Dystrophy\nCell Therapy\nPerformance of the Upper Limb\nPulmonary Function\nAmbulatory\nNon-Ambulatory\nGlucocorticoids","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","10 Years",null,"Male",null,"No","Undecided",null,"URL: http://capricor.com [http://capricor.com] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: Company website",null,"Yes","No",{"$nulls":19},"Change in the mid-level (elbow) dimension of the Performance of the Upper Limb (PUL)","The PUL includes functional tasks that relate to activities of daily living that are very important for quality of life. The PUL has been validated for the assessment of upper limb motor function in individuals with DMD.","Month 12","Change in the mid-level (elbow) dimension of the PUL|Change in regional systolic left ventricular wall thickening as assessed by cardiac MRI","The PUL includes functional tasks that relate to activities of daily living that are very important for quality of life. The PUL has been validated for the assessment of upper limb motor function in individuals with DMD.|Systolic thickening is thought to be a principal mechanism of cardiac output generation in people with DMD.","Months 3, 6, and 9|Months 6 and 12","HOPE-2@capricor.com","Brian Fedor","310-358-3201","Sacramento, California, United States, 95817|Aurora, Colorado, United States, 80045|Orlando, Florida, United States, 32827|Saint Louis, Missouri, United States, 63110|Salt Lake City, Utah, United States, 84112","California|Colorado|Florida|Missouri|Utah","United States","University Of California, Davis|Children's Hospital Colorado|Nemours Children's Hospital|Washington University|University Of Utah",{"$nulls":3},"Deborah D Ascheim, MD","2018-07-27","2020-05-25T16:38:02.902","2020-05-26T17:10:42.972","NCT03406780"]
["5ecbf46b307e3d1b1f8d9d90","NCT03406780","2018-08-27","Capricor","CAPR","Recruiting","A Study of CAP-1002 in Ambulatory and Non-Ambulatory Patients With Duchenne Muscular Dystrophy (HOPE-2)","Cap-1002","Immunomodulator|Apoptosis Inhibitor","Yes","['Cap-1002']","No",null,"Phase 2",2,84,"Anticipated","2018-04-04","2019-12-01",{"$nulls":5},"HOPE-2 is a double-blind clinical trial evaluating the safety and efficacy of a cell therapy called CAP-1002 in study participants with Duchenne muscular dystrophy (DMD). Non-ambulatory and ambulatory boys and young men who meet eligibility criteria will be randomly assigned to receive either CAP-1002 or placebo every 3 months for a total of 4 doses during a 12-month period.","* Approximately 84 eligible study participants will be randomized to either CAP-1002 or placebo in a 1:1 ratio.\n * The trial will include visits at Screening, Baseline/Day 1, Week 4, and Months 3, 6, 9, and 12 with IV infusions of CAP-1002 or placebo on Day 1 and Months 3, 6, and 9.\n * Safety evaluations will include adverse events, concomitant medications, physical exam, vital signs, 12-lead ECG, and clinical laboratory testing.\n * Efficacy will be evaluated in the Performance of the Upper Limb, pulmonary function testing, North Star Ambulatory Assessment (ambulatory subjects only), strength testing, cardiac MRI, and quality of life.\n * If trial data suggests an appropriate risk/benefit profile of CAP-1002, Capricor, upon the recommendation of the Data Safety Monitoring Board (DSMB), will introduce an open-label extension study to offer CAP-1002 to study participants who were randomized to placebo and completed all trial visits during the 12-month period.","A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of Intravenous Delivery of Allogeneic Cardiosphere-Derived Cells in Subjects With Duchenne Muscular Dystrophy","CAP-1002-DMD-02","Muscular Dystrophies\nMuscular Dystrophy, Duchenne\nMuscular Disorders, Atrophic\nMuscular Diseases\nNeuromuscular Diseases\nNervous System Diseases\nGenetic Diseases, X-Linked\nGenetic Diseases, Inborn","Muscular Dystrophy, Duchenne|Muscular Disorders, Atrophic|Muscular Dystrophies|Genetic Diseases, X-Linked","Muscular Diseases|Genetic Diseases, Inborn","Musculoskeletal|Neonatal Diseases & Abnormalities","Experimental|Placebo Comparator","CAP-1002|Placebo","Patients will receive 150 million cardiosphere-derived cells (CDCs) via intravenous infusion every 3 months for a total of 4 doses.|Patients will receive a placebo solution via intravenous infusion every 3 months for a total of 4 doses.","Biological|Drug","CAP-1002|Placebo","The active pharmaceutical ingredient in CAP-1002 is Cardiosphere-Derived Cells (CDCs). CDCs are known to secrete numerous bioactive elements (growth factors, exosomes) which impact the therapeutic benefits of the cell-based therapy. The mechanism of action is the composite ability to be immunomodulatory, anti-fibrotic and regenerative.|Placebo","Cardiosphere-Derived Cells | CDCs","CAP-1002|Placebo","\n\n 1. Genetically confirmed DMD\n 2. Reduced upper arm strength as measured by the Performance of Upper Limb\n 3. Reduced ability to walk/run (if ambulatory)\n 4. Treatment with systemic glucocorticoids for at least 12 months and at a stable dose at least 6 months prior to study participation, except for weight-based or toxicity-related adjustments\n 5. Current and up-to-date immunizations\n\n","\n\n 1.  Left ventricular ejection fraction < 35%\n 2.  BMI > 45\n 3.  Ambulant if â‰¥ 18 years of age\n 4.  Exon 44 skip-amenable mutation(s) in the DMD gene\n 5.  Deletion mutation(s) encompassing exons 3-7 of the DMD gene\n 6.  Percent-predicted forced vital capacity (FVC) < 35%\n 7.  Chronic respiratory disease not related to DMD (for example, asthma, bronchitis, and tuberculosis)\n 8.  History of diabetes requiring treatment with metformin or insulin within 3 months prior to randomization\n 9.  Treatment with an FDA-approved exon skipping therapy for the treatment of DMD if on a stable dose for less than 24 months prior to randomization\n 10. Treatment with human growth hormone (HGH) within 3 months prior to randomization, unless on a stable dose for at least 24 months prior to randomization\n 11. Treatment with idebenone within 3 months prior to randomization\n 12. Treatment with a cell therapy product within 12 months prior to randomization\n 13. Treatment with an investigational product within 6 months prior to randomization",{"$nulls":4},"Actual","2018-01-23","Actual","Anticipated","2020-04-01","Anticipated","2018-08-01","2018-01-15","2018-01-19","2018-08-24","Yes","Duchenne Muscular Dystrophy\nCell Therapy\nPerformance of the Upper Limb\nPulmonary Function\nAmbulatory\nNon-Ambulatory\nGlucocorticoids","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","10 Years",null,"Male",null,"No","Undecided",null,"URL: http://capricor.com [http://capricor.com] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: Company website",null,"Yes","No",{"$nulls":19},"Change in the mid-level (elbow) dimension of the Performance of the Upper Limb (PUL)","The PUL includes functional tasks that relate to activities of daily living that are very important for quality of life. The PUL has been validated for the assessment of upper limb motor function in individuals with DMD.","Month 12","Change in the mid-level (elbow) dimension of the PUL|Change in regional systolic left ventricular wall thickening as assessed by cardiac MRI","The PUL includes functional tasks that relate to activities of daily living that are very important for quality of life. The PUL has been validated for the assessment of upper limb motor function in individuals with DMD.|Systolic thickening is thought to be a principal mechanism of cardiac output generation in people with DMD.","Months 3, 6, and 9|Months 6 and 12","HOPE-2@capricor.com","Brian Fedor","310-358-3201","Sacramento, California, United States, 95817|Aurora, Colorado, United States, 80045|Orlando, Florida, United States, 32827|Atlanta, Georgia, United States, 30318|Iowa City, Iowa, United States, 52242|Saint Louis, Missouri, United States, 63110|Cincinnati, Ohio, United States, 45229|Salt Lake City, Utah, United States, 84112","California|Colorado|Florida|Georgia|Iowa|Missouri|Ohio|Utah","United States","University Of California, Davis|Children's Hospital Colorado|Nemours Children's Hospital|Rare Disease Research|University Of Iowa Stead Family Children's Hospital|Washington University|Cincinnati Children's Hospital Medical Center|University Of Utah",{"$nulls":3},"Deborah D Ascheim, MD","2018-08-24","2020-05-25T16:38:03.719","2020-05-26T17:10:42.972","NCT03406780"]
["5ecbf46be2561b1b11905dfb","NCT03406780","2018-10-19","Capricor","CAPR","Recruiting","A Study of CAP-1002 in Ambulatory and Non-Ambulatory Patients With Duchenne Muscular Dystrophy (HOPE-2)","Cap-1002","Immunomodulator|Apoptosis Inhibitor","Yes","['Cap-1002']","No",null,"Phase 2",2,84,"Anticipated","2018-04-04","2019-12-01",{"$nulls":5},"HOPE-2 is a double-blind clinical trial evaluating the safety and efficacy of a cell therapy called CAP-1002 in study participants with Duchenne muscular dystrophy (DMD). Non-ambulatory and ambulatory boys and young men who meet eligibility criteria will be randomly assigned to receive either CAP-1002 or placebo every 3 months for a total of 4 doses during a 12-month period.","* Approximately 84 eligible study participants will be randomized to either CAP-1002 or placebo in a 1:1 ratio.\n * The trial will include visits at Screening, Baseline/Day 1, Week 4, and Months 3, 6, 9, and 12 with IV infusions of CAP-1002 or placebo on Day 1 and Months 3, 6, and 9.\n * Safety evaluations will include adverse events, concomitant medications, physical exam, vital signs, 12-lead ECG, and clinical laboratory testing.\n * Efficacy will be evaluated in the Performance of the Upper Limb, pulmonary function testing, North Star Ambulatory Assessment (ambulatory subjects only), strength testing, cardiac MRI, and quality of life.\n * If trial data suggests an appropriate risk/benefit profile of CAP-1002, Capricor, upon the recommendation of the Data Safety Monitoring Board (DSMB), will introduce an open-label extension study to offer CAP-1002 to study participants who were randomized to placebo and completed all trial visits during the 12-month period.","A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of Intravenous Delivery of Allogeneic Cardiosphere-Derived Cells in Subjects With Duchenne Muscular Dystrophy","CAP-1002-DMD-02","Muscular Dystrophies\nMuscular Dystrophy, Duchenne\nMuscular Disorders, Atrophic\nMuscular Diseases\nNeuromuscular Diseases\nNervous System Diseases\nGenetic Diseases, X-Linked\nGenetic Diseases, Inborn","Muscular Dystrophy, Duchenne|Muscular Disorders, Atrophic|Muscular Dystrophies|Genetic Diseases, X-Linked","Muscular Diseases|Genetic Diseases, Inborn","Musculoskeletal|Neonatal Diseases & Abnormalities","Experimental|Placebo Comparator","CAP-1002|Placebo","Patients will receive 150 million cardiosphere-derived cells (CDCs) via intravenous infusion every 3 months for a total of 4 doses.|Patients will receive a placebo solution via intravenous infusion every 3 months for a total of 4 doses.","Biological|Drug","CAP-1002|Placebo","The active pharmaceutical ingredient in CAP-1002 is Cardiosphere-Derived Cells (CDCs). CDCs are known to secrete numerous bioactive elements (growth factors, exosomes) which impact the therapeutic benefits of the cell-based therapy. The mechanism of action is the composite ability to be immunomodulatory, anti-fibrotic and regenerative.|Placebo","Cardiosphere-Derived Cells | CDCs","CAP-1002|Placebo","\n\n 1. Genetically confirmed DMD\n 2. Reduced upper arm strength as measured by the Performance of Upper Limb\n 3. Reduced ability to walk/run (if ambulatory)\n 4. Treatment with systemic glucocorticoids for at least 12 months and at a stable dose at least 6 months prior to study participation, except for weight-based or toxicity-related adjustments\n 5. Current and up-to-date immunizations\n\n","\n\n 1.  Left ventricular ejection fraction < 35%\n 2.  BMI > 45\n 3.  Ambulant if â‰¥ 18 years of age\n 4.  Exon 44 skip-amenable mutation(s) in the DMD gene\n 5.  Deletion mutation(s) encompassing exons 3-7 of the DMD gene\n 6.  Percent-predicted forced vital capacity (FVC) < 35%\n 7.  Chronic respiratory disease not related to DMD (for example, asthma, bronchitis, and tuberculosis)\n 8.  History of diabetes requiring treatment with metformin or insulin within 3 months prior to randomization\n 9.  Treatment with an FDA-approved exon skipping therapy for the treatment of DMD if on a stable dose for less than 24 months prior to randomization\n 10. Treatment with human growth hormone (HGH) within 3 months prior to randomization, unless on a stable dose for at least 24 months prior to randomization\n 11. Treatment with idebenone within 3 months prior to randomization\n 12. Treatment with a cell therapy product within 12 months prior to randomization\n 13. Treatment with an investigational product within 6 months prior to randomization",{"$nulls":4},"Actual","2018-01-23","Actual","Anticipated","2020-04-01","Anticipated","2018-10-01","2018-01-15","2018-01-19","2018-10-18","Yes","Duchenne Muscular Dystrophy\nCell Therapy\nPerformance of the Upper Limb\nPulmonary Function\nAmbulatory\nNon-Ambulatory\nGlucocorticoids","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","10 Years",null,"Male",null,"No","Undecided",null,"URL: http://capricor.com [http://capricor.com] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: Company website",null,"Yes","No",{"$nulls":19},"Change in the mid-level (elbow) dimension of the Performance of the Upper Limb (PUL)","The PUL includes functional tasks that relate to activities of daily living that are very important for quality of life. The PUL has been validated for the assessment of upper limb motor function in individuals with DMD.","Month 12","Change in the mid-level (elbow) dimension of the PUL|Change in regional systolic left ventricular wall thickening as assessed by cardiac MRI","The PUL includes functional tasks that relate to activities of daily living that are very important for quality of life. The PUL has been validated for the assessment of upper limb motor function in individuals with DMD.|Systolic thickening is thought to be a principal mechanism of cardiac output generation in people with DMD.","Months 3, 6, and 9|Months 6 and 12","HOPE-2@capricor.com","Brian Fedor","310-358-3201","Sacramento, California, United States, 95817|Aurora, Colorado, United States, 80045|Orlando, Florida, United States, 32827|Atlanta, Georgia, United States, 30318|Iowa City, Iowa, United States, 52242|Worcester, Massachusetts, United States, 01655|Saint Louis, Missouri, United States, 63110|Cincinnati, Ohio, United States, 45229|Dallas, Texas, United States, 75235|Salt Lake City, Utah, United States, 84112|Milwaukee, Wisconsin, United States, 53226","California|Colorado|Florida|Georgia|Iowa|Massachusetts|Missouri|Ohio|Texas|Utah|Wisconsin","United States","University Of California, Davis|Children's Hospital Colorado|Nemours Children's Hospital|Rare Disease Research|University Of Iowa Stead Family Children's Hospital|University Of Massachusetts Medical Center|Washington University|Cincinnati Children's Hospital Medical Center|Children's/ Ut Southwestern Medical Center|University Of Utah|Children's Hospital Wisconsin",{"$nulls":3},"Deborah D Ascheim, MD","2018-10-18","2020-05-25T16:38:03.795","2020-05-26T17:10:42.972","NCT03406780"]
["5ecbf46be2561b1b11905dfa","NCT03406780","2018-12-10","Capricor","CAPR","Recruiting","A Study of CAP-1002 in Ambulatory and Non-Ambulatory Patients With Duchenne Muscular Dystrophy (HOPE-2)","Cap-1002","Immunomodulator|Apoptosis Inhibitor","Yes","['Cap-1002']","No",null,"Phase 2",2,84,"Anticipated","2018-04-04","2019-12-01",{"$nulls":5},"HOPE-2 is a double-blind clinical trial evaluating the safety and efficacy of a cell therapy called CAP-1002 in study participants with Duchenne muscular dystrophy (DMD). Non-ambulatory and ambulatory boys and young men who meet eligibility criteria will be randomly assigned to receive either CAP-1002 or placebo every 3 months for a total of 4 doses during a 12-month period.","* Approximately 84 eligible study participants will be randomized to either CAP-1002 or placebo in a 1:1 ratio.\n * The trial will include visits at Screening, Baseline/Day 1, Week 4, and Months 3, 6, 9, and 12 with IV infusions of CAP-1002 or placebo on Day 1 and Months 3, 6, and 9.\n * Safety evaluations will include adverse events, concomitant medications, physical exam, vital signs, 12-lead ECG, and clinical laboratory testing.\n * Efficacy will be evaluated in the Performance of the Upper Limb, pulmonary function testing, North Star Ambulatory Assessment (ambulatory subjects only), strength testing, cardiac MRI, and quality of life.\n * If trial data suggests an appropriate risk/benefit profile of CAP-1002, Capricor, upon the recommendation of the Data Safety Monitoring Board (DSMB), will introduce an open-label extension study to offer CAP-1002 to study participants who were randomized to placebo and completed all trial visits during the 12-month period.","A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of Intravenous Delivery of Allogeneic Cardiosphere-Derived Cells in Subjects With Duchenne Muscular Dystrophy","CAP-1002-DMD-02","Muscular Dystrophies\nMuscular Dystrophy, Duchenne\nMuscular Disorders, Atrophic\nMuscular Diseases\nNeuromuscular Diseases\nNervous System Diseases\nGenetic Diseases, X-Linked\nGenetic Diseases, Inborn","Muscular Dystrophy, Duchenne|Muscular Disorders, Atrophic|Muscular Dystrophies|Genetic Diseases, X-Linked","Muscular Diseases|Genetic Diseases, Inborn","Musculoskeletal|Neonatal Diseases & Abnormalities","Experimental|Placebo Comparator","CAP-1002|Placebo","Patients will receive 150 million cardiosphere-derived cells (CDCs) via intravenous infusion every 3 months for a total of 4 doses.|Patients will receive a placebo solution via intravenous infusion every 3 months for a total of 4 doses.","Biological|Drug","CAP-1002|Placebo","The active pharmaceutical ingredient in CAP-1002 is Cardiosphere-Derived Cells (CDCs). CDCs are known to secrete numerous bioactive elements (growth factors, exosomes) which impact the therapeutic benefits of the cell-based therapy. The mechanism of action is the composite ability to be immunomodulatory, anti-fibrotic and regenerative.|Placebo","Cardiosphere-Derived Cells | CDCs","CAP-1002|Placebo","\n\n 1. Genetically confirmed DMD\n 2. Reduced upper arm strength as measured by the Performance of Upper Limb\n 3. Reduced ability to walk/run (if ambulatory)\n 4. Treatment with systemic glucocorticoids for at least 12 months and at a stable dose at least 6 months prior to study participation, except for weight-based or toxicity-related adjustments\n 5. Current and up-to-date immunizations\n\n","\n\n 1.  Left ventricular ejection fraction < 35%\n 2.  BMI > 45\n 3.  Ambulant if â‰¥ 18 years of age\n 4.  Exon 44 skip-amenable mutation(s) in the DMD gene\n 5.  Deletion mutation(s) encompassing exons 3-7 of the DMD gene\n 6.  Percent-predicted forced vital capacity (FVC) < 35%\n 7.  Chronic respiratory disease not related to DMD (for example, asthma, bronchitis, and tuberculosis)\n 8.  History of diabetes requiring treatment with metformin or insulin within 3 months prior to randomization\n 9.  Treatment with an FDA-approved exon skipping therapy for the treatment of DMD if on a stable dose for less than 24 months prior to randomization\n 10. Treatment with human growth hormone (HGH) within 3 months prior to randomization, unless on a stable dose for at least 24 months prior to randomization\n 11. Treatment with idebenone within 3 months prior to randomization\n 12. Treatment with a cell therapy product within 12 months prior to randomization\n 13. Treatment with an investigational product within 6 months prior to randomization",{"$nulls":4},"Actual","2018-01-23","Actual","Anticipated","2020-04-01","Anticipated","2018-12-01","2018-01-15","2018-01-19","2018-12-07","Yes","Duchenne Muscular Dystrophy\nCell Therapy\nPerformance of the Upper Limb\nPulmonary Function\nAmbulatory\nNon-Ambulatory\nGlucocorticoids","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","10 Years",null,"Male",null,"No","Undecided",null,"URL: http://capricor.com [http://capricor.com] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: Company website",null,"Yes","No",{"$nulls":19},"Change in the mid-level (elbow) dimension of the Performance of the Upper Limb (PUL)","The PUL includes functional tasks that relate to activities of daily living that are very important for quality of life. The PUL has been validated for the assessment of upper limb motor function in individuals with DMD.","Month 12","Change in the mid-level (elbow) dimension of the PUL|Change in regional systolic left ventricular wall thickening as assessed by cardiac MRI","The PUL includes functional tasks that relate to activities of daily living that are very important for quality of life. The PUL has been validated for the assessment of upper limb motor function in individuals with DMD.|Systolic thickening is thought to be a principal mechanism of cardiac output generation in people with DMD.","Months 3, 6, and 9|Months 6 and 12","HOPE-2@capricor.com","Paula Williams","310-358-3200","Sacramento, California, United States, 95817|Aurora, Colorado, United States, 80045|Orlando, Florida, United States, 32827|Atlanta, Georgia, United States, 30318|Iowa City, Iowa, United States, 52242|Worcester, Massachusetts, United States, 01655|Saint Louis, Missouri, United States, 63110|Cincinnati, Ohio, United States, 45229|Dallas, Texas, United States, 75235|Salt Lake City, Utah, United States, 84112|Milwaukee, Wisconsin, United States, 53226","California|Colorado|Florida|Georgia|Iowa|Massachusetts|Missouri|Ohio|Texas|Utah|Wisconsin","United States","University Of California, Davis|Children's Hospital Colorado|Nemours Children's Hospital|Rare Disease Research|University Of Iowa Stead Family Children's Hospital|University Of Massachusetts Medical Center|Washington University|Cincinnati Children's Hospital Medical Center|Children's/ Ut Southwestern Medical Center|University Of Utah|Children's Hospital Wisconsin",{"$nulls":3},"Catherine Kelleher, MD","2018-12-07","2020-05-25T16:38:03.720","2020-05-26T17:10:42.972","NCT03406780"]
["5ecbf46cfe30261b1a048301","NCT03406780","2019-01-31","Capricor","CAPR","Active, not recruiting","A Study of CAP-1002 in Ambulatory and Non-Ambulatory Patients With Duchenne Muscular Dystrophy (HOPE-2)","Cap-1002","Immunomodulator|Apoptosis Inhibitor","Yes","['Cap-1002']","No",null,"Phase 2",2,18,"Actual","2018-04-04","2019-12-01",{"$nulls":5},"HOPE-2 is a double-blind clinical trial evaluating the safety and efficacy of a cell therapy called CAP-1002 in study participants with Duchenne muscular dystrophy (DMD). Non-ambulatory and ambulatory boys and young men who meet eligibility criteria will be randomly assigned to receive either CAP-1002 or placebo every 3 months for a total of 4 doses during a 12-month period.","* Approximately 84 eligible study participants will be randomized to either CAP-1002 or placebo in a 1:1 ratio.\n * The trial will include visits at Screening, Baseline/Day 1, Week 4, and Months 3, 6, 9, and 12 with IV infusions of CAP-1002 or placebo on Day 1 and Months 3, 6, and 9.\n * Safety evaluations will include adverse events, concomitant medications, physical exam, vital signs, 12-lead ECG, and clinical laboratory testing.\n * Efficacy will be evaluated in the Performance of the Upper Limb, pulmonary function testing, North Star Ambulatory Assessment (ambulatory subjects only), strength testing, cardiac MRI, and quality of life.\n * If trial data suggests an appropriate risk/benefit profile of CAP-1002, Capricor, upon the recommendation of the Data Safety Monitoring Board (DSMB), will introduce an open-label extension study to offer CAP-1002 to study participants who were randomized to placebo and completed all trial visits during the 12-month period.","A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of Intravenous Delivery of Allogeneic Cardiosphere-Derived Cells in Subjects With Duchenne Muscular Dystrophy","CAP-1002-DMD-02","Muscular Dystrophies\nMuscular Dystrophy, Duchenne\nMuscular Disorders, Atrophic\nMuscular Diseases\nNeuromuscular Diseases\nNervous System Diseases\nGenetic Diseases, X-Linked\nGenetic Diseases, Inborn","Muscular Dystrophy, Duchenne|Muscular Disorders, Atrophic|Muscular Dystrophies|Genetic Diseases, X-Linked","Muscular Diseases|Genetic Diseases, Inborn","Musculoskeletal|Neonatal Diseases & Abnormalities","Experimental|Placebo Comparator","CAP-1002|Placebo","Patients will receive 150 million cardiosphere-derived cells (CDCs) via intravenous infusion every 3 months for a total of 4 doses.|Patients will receive a placebo solution via intravenous infusion every 3 months for a total of 4 doses.","Biological|Drug","CAP-1002|Placebo","The active pharmaceutical ingredient in CAP-1002 is Cardiosphere-Derived Cells (CDCs). CDCs are known to secrete numerous bioactive elements (growth factors, exosomes) which impact the therapeutic benefits of the cell-based therapy. The mechanism of action is the composite ability to be immunomodulatory, anti-fibrotic and regenerative.|Placebo","Cardiosphere-Derived Cells | CDCs","CAP-1002|Placebo","\n\n 1. Genetically confirmed DMD\n 2. Reduced upper arm strength as measured by the Performance of Upper Limb\n 3. Reduced ability to walk/run (if ambulatory)\n 4. Treatment with systemic glucocorticoids for at least 12 months and at a stable dose at least 6 months prior to study participation, except for weight-based or toxicity-related adjustments\n 5. Current and up-to-date immunizations\n\n","\n\n 1.  Left ventricular ejection fraction < 35%\n 2.  BMI > 45\n 3.  Ambulant if â‰¥ 18 years of age\n 4.  Exon 44 skip-amenable mutation(s) in the DMD gene\n 5.  Deletion mutation(s) encompassing exons 3-7 of the DMD gene\n 6.  Percent-predicted forced vital capacity (FVC) < 35%\n 7.  Chronic respiratory disease not related to DMD (for example, asthma, bronchitis, and tuberculosis)\n 8.  History of diabetes requiring treatment with metformin or insulin within 3 months prior to randomization\n 9.  Treatment with an FDA-approved exon skipping therapy for the treatment of DMD if on a stable dose for less than 24 months prior to randomization\n 10. Treatment with human growth hormone (HGH) within 3 months prior to randomization, unless on a stable dose for at least 24 months prior to randomization\n 11. Treatment with idebenone within 3 months prior to randomization\n 12. Treatment with a cell therapy product within 12 months prior to randomization\n 13. Treatment with an investigational product within 6 months prior to randomization",{"$nulls":4},"Actual","2018-01-23","Actual","Anticipated","2020-04-01","Anticipated","2019-01-01","2018-01-15","2018-01-19","2019-01-29","Yes","Duchenne Muscular Dystrophy\nCell Therapy\nPerformance of the Upper Limb\nPulmonary Function\nAmbulatory\nNon-Ambulatory\nGlucocorticoids","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","10 Years",null,"Male",null,"No","Undecided",null,"URL: http://capricor.com [http://capricor.com] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: Company website",null,"Yes","No",{"$nulls":19},"Change in the mid-level (elbow) dimension of the Performance of the Upper Limb (PUL)","The PUL includes functional tasks that relate to activities of daily living that are very important for quality of life. The PUL has been validated for the assessment of upper limb motor function in individuals with DMD.","Month 12","Change in the mid-level (elbow) dimension of the PUL|Change in regional systolic left ventricular wall thickening as assessed by cardiac MRI","The PUL includes functional tasks that relate to activities of daily living that are very important for quality of life. The PUL has been validated for the assessment of upper limb motor function in individuals with DMD.|Systolic thickening is thought to be a principal mechanism of cardiac output generation in people with DMD.","Months 3, 6, and 9|Months 6 and 12",{"$nulls":3},"Los Angeles, California, United States, 90095 University Of California, DavisSacramento, California, United States, 95817|Aurora, Colorado, United States, 80045|Orlando, Florida, United States, 32827|Atlanta, Georgia, United States, 30318|Iowa City, Iowa, United States, 52242|Worcester, Massachusetts, United States, 01655|Saint Louis, Missouri, United States, 63110|Cincinnati, Ohio, United States, 45229|Portland, Oregon, United States, 97239|Dallas, Texas, United States, 75235|Salt Lake City, Utah, United States, 84112|Richmond, Virginia, United States, 23298|Milwaukee, Wisconsin, United States, 53226","California|Colorado|Florida|Georgia|Iowa|Massachusetts|Missouri|Ohio|Oregon|Texas|Utah|Virginia|Wisconsin","United States","Ronald Reagan Ucla Medical Center|Children's Hospital Colorado|Nemours Children's Hospital|Rare Disease Research|University Of Iowa Stead Family Children's Hospital|University Of Massachusetts Medical Center|Washington University|Cincinnati Children's Hospital Medical Center|Oregon Health And Science University|Children's/ Ut Southwestern Medical Center|University Of Utah|Virginia Commonwealth University|Children's Hospital Wisconsin",{"$nulls":3},"Catherine Kelleher, MD","2019-01-29","2020-05-25T16:38:04.057","2020-05-26T17:10:42.972","NCT03406780"]
["5ecbf46bfeab101b1553092f","NCT03406780","2019-02-04","Capricor","CAPR","Active, not recruiting","A Study of CAP-1002 in Ambulatory and Non-Ambulatory Patients With Duchenne Muscular Dystrophy (HOPE-2)","Cap-1002","Immunomodulator|Apoptosis Inhibitor","Yes","['Cap-1002']","No",null,"Phase 2",2,18,"Actual","2018-04-04","2019-12-01",{"$nulls":5},"HOPE-2 is a double-blind clinical trial evaluating the safety and efficacy of a cell therapy called CAP-1002 in study participants with Duchenne muscular dystrophy (DMD). Non-ambulatory and ambulatory boys and young men who meet eligibility criteria will be randomly assigned to receive either CAP-1002 or placebo every 3 months for a total of 4 doses during a 12-month period.","* Approximately 84 eligible study participants will be randomized to either CAP-1002 or placebo in a 1:1 ratio.\n * The trial will include visits at Screening, Baseline/Day 1, Week 4, and Months 3, 6, 9, and 12 with IV infusions of CAP-1002 or placebo on Day 1 and Months 3, 6, and 9.\n * Safety evaluations will include adverse events, concomitant medications, physical exam, vital signs, 12-lead ECG, and clinical laboratory testing.\n * Efficacy will be evaluated in the Performance of the Upper Limb, pulmonary function testing, North Star Ambulatory Assessment (ambulatory subjects only), strength testing, cardiac MRI, and quality of life.\n * If trial data suggests an appropriate risk/benefit profile of CAP-1002, Capricor, upon the recommendation of the Data Safety Monitoring Board (DSMB), will introduce an open-label extension study to offer CAP-1002 to study participants who were randomized to placebo and completed all trial visits during the 12-month period.","A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of Intravenous Delivery of Allogeneic Cardiosphere-Derived Cells in Subjects With Duchenne Muscular Dystrophy","CAP-1002-DMD-02","Muscular Dystrophies\nMuscular Dystrophy, Duchenne\nMuscular Disorders, Atrophic\nMuscular Diseases\nNeuromuscular Diseases\nNervous System Diseases\nGenetic Diseases, X-Linked\nGenetic Diseases, Inborn","Muscular Dystrophy, Duchenne|Muscular Disorders, Atrophic|Muscular Dystrophies|Genetic Diseases, X-Linked","Muscular Diseases|Genetic Diseases, Inborn","Musculoskeletal|Neonatal Diseases & Abnormalities","Experimental|Placebo Comparator","CAP-1002|Placebo","Patients will receive 150 million cardiosphere-derived cells (CDCs) via intravenous infusion every 3 months for a total of 4 doses.|Patients will receive a placebo solution via intravenous infusion every 3 months for a total of 4 doses.","Biological|Drug","CAP-1002|Placebo","The active pharmaceutical ingredient in CAP-1002 is Cardiosphere-Derived Cells (CDCs). CDCs are known to secrete numerous bioactive elements (growth factors, exosomes) which impact the therapeutic benefits of the cell-based therapy. The mechanism of action is the composite ability to be immunomodulatory, anti-fibrotic and regenerative.|Placebo","Cardiosphere-Derived Cells | CDCs","CAP-1002|Placebo","\n\n 1. Genetically confirmed DMD\n 2. Reduced upper arm strength as measured by the Performance of Upper Limb\n 3. Reduced ability to walk/run (if ambulatory)\n 4. Treatment with systemic glucocorticoids for at least 12 months and at a stable dose at least 6 months prior to study participation, except for weight-based or toxicity-related adjustments\n 5. Current and up-to-date immunizations\n\n","\n\n 1.  Left ventricular ejection fraction < 35%\n 2.  BMI > 45\n 3.  Ambulant if â‰¥ 18 years of age\n 4.  Exon 44 skip-amenable mutation(s) in the DMD gene\n 5.  Deletion mutation(s) encompassing exons 3-7 of the DMD gene\n 6.  Percent-predicted forced vital capacity (FVC) < 35%\n 7.  Chronic respiratory disease not related to DMD (for example, asthma, bronchitis, and tuberculosis)\n 8.  History of diabetes requiring treatment with metformin or insulin within 3 months prior to randomization\n 9.  Treatment with an FDA-approved exon skipping therapy for the treatment of DMD if on a stable dose for less than 24 months prior to randomization\n 10. Treatment with human growth hormone (HGH) within 3 months prior to randomization, unless on a stable dose for at least 24 months prior to randomization\n 11. Treatment with idebenone within 3 months prior to randomization\n 12. Treatment with a cell therapy product within 12 months prior to randomization\n 13. Treatment with an investigational product within 6 months prior to randomization",{"$nulls":4},"Actual","2018-01-23","Actual","Anticipated","2020-04-01","Anticipated","2019-01-01","2018-01-15","2018-01-19","2019-01-31","Yes","Duchenne Muscular Dystrophy\nCell Therapy\nPerformance of the Upper Limb\nPulmonary Function\nAmbulatory\nNon-Ambulatory\nGlucocorticoids","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","10 Years",null,"Male",null,"No","Undecided",null,"URL: http://capricor.com [http://capricor.com] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: Company website",null,"Yes","No",{"$nulls":19},"Change in the mid-level (elbow) dimension of the Performance of the Upper Limb (PUL)","The PUL includes functional tasks that relate to activities of daily living that are very important for quality of life. The PUL has been validated for the assessment of upper limb motor function in individuals with DMD.","Month 12","Change in the mid-level (elbow) dimension of the PUL|Change in regional systolic left ventricular wall thickening as assessed by cardiac MRI","The PUL includes functional tasks that relate to activities of daily living that are very important for quality of life. The PUL has been validated for the assessment of upper limb motor function in individuals with DMD.|Systolic thickening is thought to be a principal mechanism of cardiac output generation in people with DMD.","Months 3, 6, and 9|Months 6 and 12",{"$nulls":3},"Los Angeles, California, United States, 90095 University Of California, DavisSacramento, California, United States, 95817|Aurora, Colorado, United States, 80045|Orlando, Florida, United States, 32827|Atlanta, Georgia, United States, 30318|Iowa City, Iowa, United States, 52242|Worcester, Massachusetts, United States, 01655|Saint Louis, Missouri, United States, 63110|Cincinnati, Ohio, United States, 45229|Portland, Oregon, United States, 97239|Dallas, Texas, United States, 75235|Salt Lake City, Utah, United States, 84112|Richmond, Virginia, United States, 23298|Milwaukee, Wisconsin, United States, 53226","California|Colorado|Florida|Georgia|Iowa|Massachusetts|Missouri|Ohio|Oregon|Texas|Utah|Virginia|Wisconsin","United States","Ronald Reagan Ucla Medical Center|Children's Hospital Colorado|Nemours Children's Hospital|Rare Disease Research|University Of Iowa Stead Family Children's Hospital|University Of Massachusetts Medical Center|Washington University|Cincinnati Children's Hospital Medical Center|Oregon Health And Science University|Children's/ Ut Southwestern Medical Center|University Of Utah|Virginia Commonwealth University|Children's Hospital Wisconsin",{"$nulls":4},"2019-01-31","2020-05-25T16:38:03.811","2020-05-26T17:10:42.972","NCT03406780"]
["5ecbf46c307e3d1b1f8d9d92","NCT03406780","2019-04-11","Capricor","CAPR","Active, not recruiting","A Study of CAP-1002 in Ambulatory and Non-Ambulatory Patients With Duchenne Muscular Dystrophy (HOPE-2)","Cap-1002","Immunomodulator|Apoptosis Inhibitor","Yes","['Cap-1002']","No",null,"Phase 2",2,18,"Actual","2018-04-04","2019-12-01",{"$nulls":5},"HOPE-2 is a double-blind clinical trial evaluating the safety and efficacy of a cell therapy called CAP-1002 in study participants with Duchenne muscular dystrophy (DMD). Non-ambulatory and ambulatory boys and young men who meet eligibility criteria will be randomly assigned to receive either CAP-1002 or placebo every 3 months for a total of 4 doses during a 12-month period.","* Approximately 84 eligible study participants will be randomized to either CAP-1002 or placebo in a 1:1 ratio.\n * The trial will include visits at Screening, Baseline/Day 1, Week 4, and Months 3, 6, 9, and 12 with IV infusions of CAP-1002 or placebo on Day 1 and Months 3, 6, and 9.\n * Safety evaluations will include adverse events, concomitant medications, physical exam, vital signs, 12-lead ECG, and clinical laboratory testing.\n * Efficacy will be evaluated in the Performance of the Upper Limb, pulmonary function testing, North Star Ambulatory Assessment (ambulatory subjects only), strength testing, cardiac MRI, and quality of life.\n * If trial data suggests an appropriate risk/benefit profile of CAP-1002, Capricor, upon the recommendation of the Data Safety Monitoring Board (DSMB), will introduce an open-label extension study to offer CAP-1002 to study participants who were randomized to placebo and completed all trial visits during the 12-month period.","A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of Intravenous Delivery of Allogeneic Cardiosphere-Derived Cells in Subjects With Duchenne Muscular Dystrophy","CAP-1002-DMD-02","Muscular Dystrophies\nMuscular Dystrophy, Duchenne\nMuscular Disorders, Atrophic\nMuscular Diseases\nNeuromuscular Diseases\nNervous System Diseases\nGenetic Diseases, X-Linked\nGenetic Diseases, Inborn","Muscular Dystrophy, Duchenne|Muscular Disorders, Atrophic|Muscular Dystrophies|Genetic Diseases, X-Linked","Muscular Diseases|Genetic Diseases, Inborn","Musculoskeletal|Neonatal Diseases & Abnormalities","Experimental|Placebo Comparator","CAP-1002|Placebo","Patients will receive 150 million cardiosphere-derived cells (CDCs) via intravenous infusion every 3 months for a total of 4 doses.|Patients will receive a placebo solution via intravenous infusion every 3 months for a total of 4 doses.","Biological|Drug","CAP-1002|Placebo","The active pharmaceutical ingredient in CAP-1002 is Cardiosphere-Derived Cells (CDCs). CDCs are known to secrete numerous bioactive elements (growth factors, exosomes) which impact the therapeutic benefits of the cell-based therapy. The mechanism of action is the composite ability to be immunomodulatory, anti-fibrotic and regenerative.|Placebo","Cardiosphere-Derived Cells | CDCs","CAP-1002|Placebo","\n\n 1. Genetically confirmed DMD\n 2. Reduced upper arm strength as measured by the Performance of Upper Limb\n 3. Reduced ability to walk/run (if ambulatory)\n 4. Treatment with systemic glucocorticoids for at least 12 months and at a stable dose at least 6 months prior to study participation, except for weight-based or toxicity-related adjustments\n 5. Current and up-to-date immunizations\n\n","\n\n 1.  Left ventricular ejection fraction < 35%\n 2.  BMI > 45\n 3.  Ambulant if â‰¥ 18 years of age\n 4.  Exon 44 skip-amenable mutation(s) in the DMD gene\n 5.  Deletion mutation(s) encompassing exons 3-7 of the DMD gene\n 6.  Percent-predicted forced vital capacity (FVC) < 35%\n 7.  Chronic respiratory disease not related to DMD (for example, asthma, bronchitis, and tuberculosis)\n 8.  History of diabetes requiring treatment with metformin or insulin within 3 months prior to randomization\n 9.  Treatment with an FDA-approved exon skipping therapy for the treatment of DMD if on a stable dose for less than 24 months prior to randomization\n 10. Treatment with human growth hormone (HGH) within 3 months prior to randomization, unless on a stable dose for at least 24 months prior to randomization\n 11. Treatment with idebenone within 3 months prior to randomization\n 12. Treatment with a cell therapy product within 12 months prior to randomization\n 13. Treatment with an investigational product within 6 months prior to randomization",{"$nulls":4},"Actual","2018-01-23","Actual","Anticipated","2020-04-01","Anticipated","2019-04-01","2018-01-15","2018-01-19","2019-04-10","Yes","Duchenne Muscular Dystrophy\nCell Therapy\nPerformance of the Upper Limb\nPulmonary Function\nAmbulatory\nNon-Ambulatory\nGlucocorticoids","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","10 Years",null,"Male",null,"No","Undecided",null,"URL: http://capricor.com [http://capricor.com] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: Company website",null,"Yes","No",{"$nulls":19},"Change in the mid-level (elbow) dimension of the Performance of the Upper Limb (PUL)","The PUL includes functional tasks that relate to activities of daily living that are very important for quality of life. The PUL has been validated for the assessment of upper limb motor function in individuals with DMD.","Month 12","Change in the mid-level (elbow) dimension of the PUL|Change in regional systolic left ventricular wall thickening as assessed by cardiac MRI","The PUL includes functional tasks that relate to activities of daily living that are very important for quality of life. The PUL has been validated for the assessment of upper limb motor function in individuals with DMD.|Systolic thickening is thought to be a principal mechanism of cardiac output generation in people with DMD.","Months 3, 6, and 9|Months 6 and 12",{"$nulls":3},"Sacramento, California, United States, 95817|Aurora, Colorado, United States, 80045|Orlando, Florida, United States, 32827|Saint Louis, Missouri, United States, 63110|Cincinnati, Ohio, United States, 45229|Salt Lake City, Utah, United States, 84112|Milwaukee, Wisconsin, United States, 53226","California|Colorado|Florida|Missouri|Ohio|Utah|Wisconsin","United States","University Of California, Davis|Children's Hospital Colorado|Nemours Children's Hospital|Washington University|Cincinnati Children's Hospital Medical Center|University Of Utah|Children's Hospital Wisconsin",{"$nulls":4},"2019-04-10","2020-05-25T16:38:04.399","2020-05-26T17:10:42.972","NCT03406780"]
["5ecbf46c307e3d1b1f8d9d94","NCT03406949","2018-01-23","MacroGenics","MGNX","Not yet recruiting","Phase 1 Study of Combination MGD009/MGA012 in Relapsed/Refractory Cancer","Mgd-009|Mga-012",null,"Yes","['Mgd-009', 'Mga-012']","Unknown",null,"Phase 1",1,165,"Anticipated","2018-01-01","2020-12-01",{"$nulls":5},"The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics (PK) pharmacodynamics and preliminary antitumor activity of MGD009 administered in combination with MGA012 in patients with B7-H3- expressing tumors.","This study is a Phase 1, open-label, dose escalation, and cohort expansion study designed to characterize the safety, tolerability, PK, pharmacodynamics, immunogenicity, and preliminary antitumor activity of the combination of MGD009 and MGA012, each of which is administered by IV infusion.The study consists of a Dose Escalation Phase to determine the Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) (if no MTD is defined) of the combination, followed by a Cohort Expansion Phase to further define the safety and initial antitumor activity of the combination with the doses established in the Dose Escalation Phase. Patients with B7-H3-expressing unresectable, locally advanced, or metastatic solid tumors of any histology will be enrolled in the Dose Escalation Phase. Following the establishment of an MTD, additional patients with specific tumor types will enroll in the Cohort Expansion Phase.","A Phase 1, Open Label, Dose Escalation Study of MGD009, a Humanized B7-H3 x CD3 DARTÂ® Protein, in Combination With MGA012, an Anti-PD-1 Antibody, in Patients With Relapsed or Refractory B7-H3-Expressing Tumors","CP-MGD009-02","Advanced Solid Tumors","Oncology Solid Tumor Unspecified|Oncology Unspecified","Oncology Solid Tumor|Oncology Unspecified","Oncology","Experimental","MGD009 + MGA012","B7-H3 x CD3 DART protein + anti-PD-1 antibody","Biological","MGD009|MGA012","B7-H3 x CD3 DART protein|anti-PD-1 antibody",null,"MGD009 + MGA012","\n\n * Histologically-proven, unresectable locally advanced or metastatic solid tumors of any histology that test positive for B7-H3 expression on tumor cells or vasculature for whom no approved therapy with demonstrated clinical benefit is available. For all tumor types, the requirement for previous systemic therapy may be waived if a patient was intolerant of or refused standard first-line therapy\n * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n * Life expectancy â‰¥ 12 weeks\n * Measurable disease, with the exception of prostate cancer\n * Tissue specimen available for B7-H3 and PD-L1 expression testing\n * Acceptable laboratory parameters\n * Patients who have previously received an immune checkpoint inhibitor (e.g., anti- PD-L1, anti-PD-1, anti-CTLA-4) prior to enrollment must have toxicities related to the checkpoint inhibitor resolved to â‰¤ Grade 1 or baseline (prior to the checkpoint inhibitor) to be eligible for enrollment. Patients who experienced previous hypothyroidism toxicity on a checkpoint inhibitor are eligible to enter study regardless of Grade resolution as long as the patient is well controlled on thyroid replacement hormones.\n\n","\n\n * Patients with history of prior central nervous system (CNS) metastasis must have been treated, must be asymptomatic, and must not have any of the following at the time of enrollment: 1. No concurrent treatment for the CNS disease (e.g. surgery, radiation, corticosteroids >10 mg prednisone/day or equivalent)\n    2. No progression of CNS metastases on MRI or CT for at least 14 days after last day of prior therapy for the CNS metastases\n    3. No concurrent leptomeningeal disease or cord compression\n   \n   \n * Patients with any history of known or suspected autoimmune disease with the specific exceptions of vitiligo, resolved childhood atopic dermatitis, psoriasis not requiring systemic treatment (within the past 2 years), and patients with a history of Grave's disease that are now euthyroid clinically and by laboratory testing\n * Treatment with any, investigational therapy within the 4 weeks prior to the initiation of study drug administration\n * Treatment with any systemic chemotherapy within 3 weeks\n * Treatment with radiation therapy within 2 weeks\n * Treatment with systemic corticosteroids (> 10 mg per day prednisone or equivalent) or other immune suppressive drugs within 2 weeks\n * Clinically significant cardiovascular or pulmonary disease\n * Evidence of active viral, bacterial, or systemic fungal infection requiring parenteral treatment within 7 days prior to the initiation of study drug. Patients requiring any systemic antiviral, antifungal, or antibacterial therapy for active infection must have completed treatment no less than one week prior to the initiation of study drug.\n * Known history of positive testing for human immunodeficiency virus or history of acquired immune deficiency syndrome\n * Known history of hepatitis B or hepatitis C infection or known positive test for hepatitis B surface antigen, hepatitis B core antigen, or hepatitis C polymerase chain reaction",{"$nulls":4},"Actual","2018-01-23","Actual","Anticipated","2022-12-01","Anticipated","2018-01-01","2018-01-16","2018-01-16","2018-01-16","No",null,"Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":19},"Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v4.03|MTD/MAD","Safety is based on evaluation of adverse events (AEs) and serious adverse events (SAEs) from the time of study drug administration through the End of Study visit.|Maximum Tolerated or Administrated Dose of MGD009 and MGA012","30 months|18 months","AUC|Cmax|Tmax|Ctrough|CL|Vss|t1/2|ADA|Anti-tumor activity","Area Under the Plasma Concentration versus Time Curve of MGD009 and MGA012|Maximum Plasma Concentration of MGD009 and MGA012|Time to reach maximum (peak) plasma concentration of MGD009 and MGA012|Trough plasma concentration of MGD009 and MGA012|Total body clearance of the drug from plasma of MGD009 and MGA012|Apparent volume of distribution at steady state of MGD009 and MGA012|Terminal half life of MGD009 and MGA012|Percent of patients with anti-drug antibody to MGD009 and MGA012|Conventional Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and immune-related response criteria (irRECIST)","30 months","harlessl-ext@macrogenics.com","Lacey Harless","805-439-2470","Nashville, Tennessee, United States, 37203|Dallas, Texas, United States, 75251|Fairfax, Virginia, United States, 22031","Tennessee|Texas|Virginia","United States","Sarah Cannon Research Institute|Mary Crowley Cancer Center|Virginia Cancer Specialists",{"$nulls":3},"Sadhna Shankar, MD, MPH","2018-01-16","2020-05-25T16:38:04.994","2020-05-26T17:10:42.972","NCT03406949"]
["5ecbf46ce2561b1b11905dfd","NCT03406949","2018-03-13","MacroGenics","MGNX","Recruiting","MGD009/MGA012 Combination in Relapsed/Refractory Cancer","Mgd-009|Mga-012",null,"Yes","['Mgd-009', 'Mga-012']","Unknown",null,"Phase 1",1,165,"Anticipated","2018-02-27","2020-12-01",{"$nulls":5},"The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics (PK) pharmacodynamics and preliminary antitumor activity of MGD009 administered in combination with MGA012 in patients with B7-H3- expressing tumors.","This study is a Phase 1, open-label, dose escalation, and cohort expansion study designed to characterize the safety, tolerability, PK, pharmacodynamics, immunogenicity, and preliminary antitumor activity of the combination of MGD009 and MGA012, each of which is administered by IV infusion.The study consists of a Dose Escalation Phase to determine the Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) (if no MTD is defined) of the combination, followed by a Cohort Expansion Phase to further define the safety and initial antitumor activity of the combination with the doses established in the Dose Escalation Phase. Patients with B7-H3-expressing unresectable, locally advanced, or metastatic solid tumors of any histology will be enrolled in the Dose Escalation Phase. Following the establishment of an MTD, additional patients with specific tumor types will enroll in the Cohort Expansion Phase.","A Phase 1, Open Label, Dose Escalation Study of MGD009, a Humanized B7-H3 x CD3 DARTÂ® Protein, in Combination With MGA012, an Anti-PD-1 Antibody, in Patients With Relapsed or Refractory B7-H3-Expressing Tumors","CP-MGD009-02","Advanced Solid Tumors","Oncology Solid Tumor Unspecified|Oncology Unspecified","Oncology Solid Tumor|Oncology Unspecified","Oncology","Experimental","MGD009 + MGA012","B7-H3 x CD3 DART protein + anti-PD-1 antibody","Biological","MGD009|MGA012","B7-H3 x CD3 DART protein|anti-PD-1 antibody",null,"MGD009 + MGA012","\n\n * Histologically-proven, unresectable locally advanced or metastatic solid tumors of any histology that test positive for B7-H3 expression on tumor cells or vasculature for whom no approved therapy with demonstrated clinical benefit is available. For all tumor types, the requirement for previous systemic therapy may be waived if a patient was intolerant of or refused standard first-line therapy\n * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n * Life expectancy â‰¥ 12 weeks\n * Measurable disease, with the exception of prostate cancer\n * Tissue specimen available for B7-H3 and PD-L1 expression testing\n * Acceptable laboratory parameters\n * Patients who have previously received an immune checkpoint inhibitor (e.g., anti- PD-L1, anti-PD-1, anti-CTLA-4) prior to enrollment must have toxicities related to the checkpoint inhibitor resolved to â‰¤ Grade 1 or baseline (prior to the checkpoint inhibitor) to be eligible for enrollment. Patients who experienced previous hypothyroidism toxicity on a checkpoint inhibitor are eligible to enter study regardless of Grade resolution as long as the patient is well controlled on thyroid replacement hormones.\n\n","\n\n * Patients with history of prior central nervous system (CNS) metastasis must have been treated, must be asymptomatic, and must not have any of the following at the time of enrollment: 1. No concurrent treatment for the CNS disease (e.g. surgery, radiation, corticosteroids >10 mg prednisone/day or equivalent)\n    2. No progression of CNS metastases on MRI or CT for at least 14 days after last day of prior therapy for the CNS metastases\n    3. No concurrent leptomeningeal disease or cord compression\n   \n   \n * Patients with any history of known or suspected autoimmune disease with the specific exceptions of vitiligo, resolved childhood atopic dermatitis, psoriasis not requiring systemic treatment (within the past 2 years), and patients with a history of Grave's disease that are now euthyroid clinically and by laboratory testing\n * Treatment with any, investigational therapy within the 4 weeks prior to the initiation of study drug administration\n * Treatment with any systemic chemotherapy within 3 weeks\n * Treatment with radiation therapy within 2 weeks\n * Treatment with systemic corticosteroids (> 10 mg per day prednisone or equivalent) or other immune suppressive drugs within 2 weeks\n * Clinically significant cardiovascular or pulmonary disease\n * Evidence of active viral, bacterial, or systemic fungal infection requiring parenteral treatment within 7 days prior to the initiation of study drug. Patients requiring any systemic antiviral, antifungal, or antibacterial therapy for active infection must have completed treatment no less than one week prior to the initiation of study drug.\n * Known history of positive testing for human immunodeficiency virus or history of acquired immune deficiency syndrome\n * Known history of hepatitis B or hepatitis C infection or known positive test for hepatitis B surface antigen, hepatitis B core antigen, or hepatitis C polymerase chain reaction",{"$nulls":4},"Actual","2018-01-23","Actual","Anticipated","2022-12-01","Anticipated","2018-03-01","2018-01-16","2018-01-16","2018-03-12","No",null,"Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":19},"Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v4.03|MTD/MAD","Safety is based on evaluation of adverse events (AEs) and serious adverse events (SAEs) from the time of study drug administration through the End of Study visit.|Maximum Tolerated or Administrated Dose of MGD009 and MGA012","30 months|18 months","AUC|Cmax|Tmax|Ctrough|CL|Vss|t1/2|ADA|Anti-tumor activity","Area Under the Plasma Concentration versus Time Curve of MGD009 and MGA012|Maximum Plasma Concentration of MGD009 and MGA012|Time to reach maximum (peak) plasma concentration of MGD009 and MGA012|Trough plasma concentration of MGD009 and MGA012|Total body clearance of the drug from plasma of MGD009 and MGA012|Apparent volume of distribution at steady state of MGD009 and MGA012|Terminal half life of MGD009 and MGA012|Percent of patients with anti-drug antibody to MGD009 and MGA012|Conventional Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and immune-related response criteria (irRECIST)","30 months","penchevap@macrogenics.com","Pepi Pencheva, MD","(240) 552-8088","Nashville, Tennessee, United States, 37203|Dallas, Texas, United States, 75251|Fairfax, Virginia, United States, 22031","Tennessee|Texas|Virginia","United States","Sarah Cannon Research Institute|Mary Crowley Cancer Center|Virginia Cancer Specialists","lowea@macrogenics.com","Ashley Lowe","(240) 552-8086","Sadhna Shankar, MD, MPH","2018-03-12","2020-05-25T16:38:04.881","2020-05-26T17:10:42.972","NCT03406949"]
["5ecbf46dfe30261b1a048303","NCT03406949","2018-06-13","MacroGenics","MGNX","Recruiting","MGD009/MGA012 Combination in Relapsed/Refractory Cancer","Mgd-009|Mga-012",null,"Yes","['Mgd-009', 'Mga-012']","Unknown",null,"Phase 1",1,165,"Anticipated","2018-02-27","2020-12-01",{"$nulls":5},"The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics (PK) pharmacodynamics and preliminary antitumor activity of MGD009 administered in combination with MGA012 in patients with B7-H3- expressing tumors.","This study is a Phase 1, open-label, dose escalation, and cohort expansion study designed to characterize the safety, tolerability, PK, pharmacodynamics, immunogenicity, and preliminary antitumor activity of the combination of MGD009 and MGA012, each of which is administered by IV infusion.The study consists of a Dose Escalation Phase to determine the Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) (if no MTD is defined) of the combination, followed by a Cohort Expansion Phase to further define the safety and initial antitumor activity of the combination with the doses established in the Dose Escalation Phase. Patients with B7-H3-expressing unresectable, locally advanced, or metastatic solid tumors of any histology will be enrolled in the Dose Escalation Phase. Following the establishment of an MTD, additional patients with specific tumor types will enroll in the Cohort Expansion Phase.","A Phase 1, Open Label, Dose Escalation Study of MGD009, a Humanized B7-H3 x CD3 DARTÂ® Protein, in Combination With MGA012, an Anti-PD-1 Antibody, in Patients With Relapsed or Refractory B7-H3-Expressing Tumors","CP-MGD009-02","Advanced Solid Tumors","Oncology Solid Tumor Unspecified|Oncology Unspecified","Oncology Solid Tumor|Oncology Unspecified","Oncology","Experimental","MGD009 + MGA012","B7-H3 x CD3 DART protein + anti-PD-1 antibody","Biological","MGD009|MGA012","B7-H3 x CD3 DART protein|anti-PD-1 antibody",null,"MGD009 + MGA012","\n\n * Histologically-proven, unresectable locally advanced or metastatic solid tumors of any histology that test positive for B7-H3 expression on tumor cells or vasculature for whom no approved therapy with demonstrated clinical benefit is available. For all tumor types, the requirement for previous systemic therapy may be waived if a patient was intolerant of or refused standard first-line therapy\n * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n * Life expectancy â‰¥ 12 weeks\n * Measurable disease, with the exception of prostate cancer\n * Tissue specimen available for B7-H3 and PD-L1 expression testing\n * Acceptable laboratory parameters\n * Patients who have previously received an immune checkpoint inhibitor (e.g., anti- PD-L1, anti-PD-1, anti-CTLA-4) prior to enrollment must have toxicities related to the checkpoint inhibitor resolved to â‰¤ Grade 1 or baseline (prior to the checkpoint inhibitor) to be eligible for enrollment. Patients who experienced previous hypothyroidism toxicity on a checkpoint inhibitor are eligible to enter study regardless of Grade resolution as long as the patient is well controlled on thyroid replacement hormones.\n\n","\n\n * Patients with history of prior central nervous system (CNS) metastasis must have been treated, must be asymptomatic, and must not have any of the following at the time of enrollment: 1. No concurrent treatment for the CNS disease (e.g. surgery, radiation, corticosteroids >10 mg prednisone/day or equivalent)\n    2. No progression of CNS metastases on MRI or CT for at least 14 days after last day of prior therapy for the CNS metastases\n    3. No concurrent leptomeningeal disease or cord compression\n   \n   \n * Patients with any history of known or suspected autoimmune disease with the specific exceptions of vitiligo, resolved childhood atopic dermatitis, psoriasis not requiring systemic treatment (within the past 2 years), and patients with a history of Grave's disease that are now euthyroid clinically and by laboratory testing\n * Treatment with any, investigational therapy within the 4 weeks prior to the initiation of study drug administration\n * Treatment with any systemic chemotherapy within 3 weeks\n * Treatment with radiation therapy within 2 weeks\n * Treatment with systemic corticosteroids (> 10 mg per day prednisone or equivalent) or other immune suppressive drugs within 2 weeks\n * Clinically significant cardiovascular or pulmonary disease\n * Evidence of active viral, bacterial, or systemic fungal infection requiring parenteral treatment within 7 days prior to the initiation of study drug. Patients requiring any systemic antiviral, antifungal, or antibacterial therapy for active infection must have completed treatment no less than one week prior to the initiation of study drug.\n * Known history of positive testing for human immunodeficiency virus or history of acquired immune deficiency syndrome\n * Known history of hepatitis B or hepatitis C infection or known positive test for hepatitis B surface antigen, hepatitis B core antigen, or hepatitis C polymerase chain reaction",{"$nulls":4},"Actual","2018-01-23","Actual","Anticipated","2022-12-01","Anticipated","2018-06-01","2018-01-16","2018-01-16","2018-06-12","No",null,"Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":19},"Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v4.03|MTD/MAD","Safety is based on evaluation of adverse events (AEs) and serious adverse events (SAEs) from the time of study drug administration through the End of Study visit.|Maximum Tolerated or Administrated Dose of MGD009 and MGA012","30 months|18 months","AUC|Cmax|Tmax|Ctrough|CL|Vss|t1/2|ADA|Anti-tumor activity","Area Under the Plasma Concentration versus Time Curve of MGD009 and MGA012|Maximum Plasma Concentration of MGD009 and MGA012|Time to reach maximum (peak) plasma concentration of MGD009 and MGA012|Trough plasma concentration of MGD009 and MGA012|Total body clearance of the drug from plasma of MGD009 and MGA012|Apparent volume of distribution at steady state of MGD009 and MGA012|Terminal half life of MGD009 and MGA012|Percent of patients with anti-drug antibody to MGD009 and MGA012|Conventional Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and immune-related response criteria (irRECIST)","30 months","wortha@macrogenics.com","Amy Worth","(240) 660-0757","Duarte, California, United States, 91010|Boston, Massachusetts, United States, 02214|Nashville, Tennessee, United States, 37203|Dallas, Texas, United States, 75251|Fairfax, Virginia, United States, 22031","California|Massachusetts|Tennessee|Texas|Virginia","United States","City Of Hope Medical Center|Massachusetts General Hospital|Sarah Cannon Research Institute|Mary Crowley Cancer Center|Virginia Cancer Specialists","lowea@macrogenics.com","Ashley Lowe","(240) 552-8086","Stacie Goldberg, MD","2018-06-12","2020-05-25T16:38:05.065","2020-05-26T17:10:42.972","NCT03406949"]
["5ecbf46ce2561b1b11905dfe","NCT03406949","2018-12-06","MacroGenics","MGNX","Recruiting","MGD009/MGA012 Combination in Relapsed/Refractory Cancer","Mgd-009|Incmga00012|Mga-012",null,"Yes","['Mgd-009', 'Incmga00012', 'Mga-012']","Unknown",null,"Phase 1",1,165,"Anticipated","2018-02-27","2020-12-01",{"$nulls":5},"The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics (PK) pharmacodynamics and preliminary antitumor activity of MGD009 administered in combination with MGA012 in patients with B7-H3- expressing tumors.","This study is a Phase 1, open-label, dose escalation, and cohort expansion study designed to characterize the safety, tolerability, PK, pharmacodynamics, immunogenicity, and preliminary antitumor activity of the combination of MGD009 and MGA012, each of which is administered by IV infusion.The study consists of a Dose Escalation Phase to determine the Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) (if no MTD is defined) of the combination, followed by a Cohort Expansion Phase to further define the safety and initial antitumor activity of the combination with the doses established in the Dose Escalation Phase. Patients with B7-H3-expressing unresectable, locally advanced, or metastatic solid tumors of any histology will be enrolled in the Dose Escalation Phase. Following the establishment of an MTD, additional patients with specific tumor types will enroll in the Cohort Expansion Phase.","A Phase 1, Open Label, Dose Escalation Study of MGD009, a Humanized B7-H3 x CD3 DARTÂ® Protein, in Combination With MGA012, an Anti-PD-1 Antibody, in Patients With Relapsed or Refractory B7-H3-Expressing Tumors","CP-MGD009-02","Advanced Solid Tumors","Oncology Solid Tumor Unspecified|Oncology Unspecified","Oncology Solid Tumor|Oncology Unspecified","Oncology","Experimental","MGD009 + MGA012","B7-H3 x CD3 DART protein + anti-PD-1 antibody","Biological","MGD009|MGA012","B7-H3 x CD3 DART protein|anti-PD-1 antibody","orlotamab|INCMGA00012","MGD009 + MGA012","\n\n * Histologically-proven, unresectable locally advanced or metastatic solid tumors of any histology that test positive for B7-H3 expression on tumor cells or vasculature for whom no approved therapy with demonstrated clinical benefit is available. For all tumor types, the requirement for previous systemic therapy may be waived if a patient was intolerant of or refused standard first-line therapy\n * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n * Life expectancy â‰¥ 12 weeks\n * Measurable disease, with the exception of prostate cancer\n * Tissue specimen available for B7-H3 and PD-L1 expression testing\n * Acceptable laboratory parameters\n * Patients who have previously received an immune checkpoint inhibitor (e.g., anti- PD-L1, anti-PD-1, anti-CTLA-4) prior to enrollment must have toxicities related to the checkpoint inhibitor resolved to â‰¤ Grade 1 or baseline (prior to the checkpoint inhibitor) to be eligible for enrollment. Patients who experienced previous hypothyroidism toxicity on a checkpoint inhibitor are eligible to enter study regardless of Grade resolution as long as the patient is well controlled on thyroid replacement hormones.\n\n","\n\n * Patients with history of prior central nervous system (CNS) metastasis must have been treated, must be asymptomatic, and must not have any of the following at the time of enrollment: 1. No concurrent treatment for the CNS disease (e.g. surgery, radiation, corticosteroids >10 mg prednisone/day or equivalent)\n    2. No progression of CNS metastases on MRI or CT for at least 14 days after last day of prior therapy for the CNS metastases\n    3. No concurrent leptomeningeal disease or cord compression\n   \n   \n * Patients with any history of known or suspected autoimmune disease with the specific exceptions of vitiligo, resolved childhood atopic dermatitis, psoriasis not requiring systemic treatment (within the past 2 years), and patients with a history of Grave's disease that are now euthyroid clinically and by laboratory testing\n * Treatment with any, investigational therapy within the 4 weeks prior to the initiation of study drug administration\n * Treatment with any systemic chemotherapy within 3 weeks\n * Treatment with radiation therapy within 2 weeks\n * Treatment with systemic corticosteroids (> 10 mg per day prednisone or equivalent) or other immune suppressive drugs within 2 weeks\n * Clinically significant cardiovascular or pulmonary disease\n * Evidence of active viral, bacterial, or systemic fungal infection requiring parenteral treatment within 7 days prior to the initiation of study drug. Patients requiring any systemic antiviral, antifungal, or antibacterial therapy for active infection must have completed treatment no less than one week prior to the initiation of study drug.\n * Known history of positive testing for human immunodeficiency virus or history of acquired immune deficiency syndrome\n * Known history of hepatitis B or hepatitis C infection or known positive test for hepatitis B surface antigen, hepatitis B core antigen, or hepatitis C polymerase chain reaction",{"$nulls":4},"Actual","2018-01-23","Actual","Anticipated","2022-12-01","Anticipated","2018-12-01","2018-01-16","2018-01-16","2018-12-04","No",null,"Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":19},"Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v4.03|MTD/MAD","Safety is based on evaluation of adverse events (AEs) and serious adverse events (SAEs) from the time of study drug administration through the End of Study visit.|Maximum Tolerated or Administrated Dose of MGD009 and MGA012","30 months|18 months","AUC|Cmax|Tmax|Ctrough|CL|Vss|t1/2|ADA|Anti-tumor activity","Area Under the Plasma Concentration versus Time Curve of MGD009 and MGA012|Maximum Plasma Concentration of MGD009 and MGA012|Time to reach maximum (peak) plasma concentration of MGD009 and MGA012|Trough plasma concentration of MGD009 and MGA012|Total body clearance of the drug from plasma of MGD009 and MGA012|Apparent volume of distribution at steady state of MGD009 and MGA012|Terminal half life of MGD009 and MGA012|Percent of patients with anti-drug antibody to MGD009 and MGA012|Conventional Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and immune-related response criteria (irRECIST)","30 months","wortha@macrogenics.com","Amy Worth","(240) 660-0757","Duarte, California, United States, 91010|Boston, Massachusetts, United States, 02214|Nashville, Tennessee, United States, 37203|Dallas, Texas, United States, 75251|Fairfax, Virginia, United States, 22031","California|Massachusetts|Tennessee|Texas|Virginia","United States","City Of Hope Medical Center|Massachusetts General Hospital|Sarah Cannon Research Institute|Mary Crowley Cancer Center|Virginia Cancer Specialists",{"$nulls":3},"Stacie Goldberg, MD","2018-12-04","2020-05-25T16:38:04.950","2020-05-26T17:10:42.972","NCT03406949"]
["5ecbf46ee2561b1b11905dff","NCT03406949","2018-12-21","MacroGenics","MGNX","Active, not recruiting","MGD009/MGA012 Combination in Relapsed/Refractory Cancer","Mgd-009|Incmga00012|Mga-012",null,"Yes","['Mgd-009', 'Incmga00012', 'Mga-012']","Unknown",null,"Phase 1",1,13,"Actual","2018-02-27","2020-12-01",{"$nulls":5},"The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics (PK) pharmacodynamics and preliminary antitumor activity of MGD009 administered in combination with MGA012 in patients with B7-H3- expressing tumors.","This study is a Phase 1, open-label, dose escalation, and cohort expansion study designed to characterize the safety, tolerability, PK, pharmacodynamics, immunogenicity, and preliminary antitumor activity of the combination of MGD009 and MGA012, each of which is administered by IV infusion.The study consists of a Dose Escalation Phase to determine the Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) (if no MTD is defined) of the combination, followed by a Cohort Expansion Phase to further define the safety and initial antitumor activity of the combination with the doses established in the Dose Escalation Phase. Patients with B7-H3-expressing unresectable, locally advanced, or metastatic solid tumors of any histology will be enrolled in the Dose Escalation Phase. Following the establishment of an MTD, additional patients with specific tumor types will enroll in the Cohort Expansion Phase.","A Phase 1, Open Label, Dose Escalation Study of MGD009, a Humanized B7-H3 x CD3 DARTÂ® Protein, in Combination With MGA012, an Anti-PD-1 Antibody, in Patients With Relapsed or Refractory B7-H3-Expressing Tumors","CP-MGD009-02","Advanced Solid Tumors","Oncology Solid Tumor Unspecified|Oncology Unspecified","Oncology Solid Tumor|Oncology Unspecified","Oncology","Experimental","MGD009 + MGA012","B7-H3 x CD3 DART protein + anti-PD-1 antibody","Biological","MGD009|MGA012","B7-H3 x CD3 DART protein|anti-PD-1 antibody","orlotamab|INCMGA00012","MGD009 + MGA012","\n\n * Histologically-proven, unresectable locally advanced or metastatic solid tumors of any histology that test positive for B7-H3 expression on tumor cells or vasculature for whom no approved therapy with demonstrated clinical benefit is available. For all tumor types, the requirement for previous systemic therapy may be waived if a patient was intolerant of or refused standard first-line therapy\n * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n * Life expectancy â‰¥ 12 weeks\n * Measurable disease, with the exception of prostate cancer\n * Tissue specimen available for B7-H3 and PD-L1 expression testing\n * Acceptable laboratory parameters\n * Patients who have previously received an immune checkpoint inhibitor (e.g., anti- PD-L1, anti-PD-1, anti-CTLA-4) prior to enrollment must have toxicities related to the checkpoint inhibitor resolved to â‰¤ Grade 1 or baseline (prior to the checkpoint inhibitor) to be eligible for enrollment. Patients who experienced previous hypothyroidism toxicity on a checkpoint inhibitor are eligible to enter study regardless of Grade resolution as long as the patient is well controlled on thyroid replacement hormones.\n\n","\n\n * Patients with history of prior central nervous system (CNS) metastasis must have been treated, must be asymptomatic, and must not have any of the following at the time of enrollment: 1. No concurrent treatment for the CNS disease (e.g. surgery, radiation, corticosteroids >10 mg prednisone/day or equivalent)\n    2. No progression of CNS metastases on MRI or CT for at least 14 days after last day of prior therapy for the CNS metastases\n    3. No concurrent leptomeningeal disease or cord compression\n   \n   \n * Patients with any history of known or suspected autoimmune disease with the specific exceptions of vitiligo, resolved childhood atopic dermatitis, psoriasis not requiring systemic treatment (within the past 2 years), and patients with a history of Grave's disease that are now euthyroid clinically and by laboratory testing\n * Treatment with any, investigational therapy within the 4 weeks prior to the initiation of study drug administration\n * Treatment with any systemic chemotherapy within 3 weeks\n * Treatment with radiation therapy within 2 weeks\n * Treatment with systemic corticosteroids (> 10 mg per day prednisone or equivalent) or other immune suppressive drugs within 2 weeks\n * Clinically significant cardiovascular or pulmonary disease\n * Evidence of active viral, bacterial, or systemic fungal infection requiring parenteral treatment within 7 days prior to the initiation of study drug. Patients requiring any systemic antiviral, antifungal, or antibacterial therapy for active infection must have completed treatment no less than one week prior to the initiation of study drug.\n * Known history of positive testing for human immunodeficiency virus or history of acquired immune deficiency syndrome\n * Known history of hepatitis B or hepatitis C infection or known positive test for hepatitis B surface antigen, hepatitis B core antigen, or hepatitis C polymerase chain reaction",{"$nulls":4},"Actual","2018-01-23","Actual","Anticipated","2022-12-01","Anticipated","2018-12-01","2018-01-16","2018-01-16","2018-12-20","No",null,"Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":19},"Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v4.03|MTD/MAD","Safety is based on evaluation of adverse events (AEs) and serious adverse events (SAEs) from the time of study drug administration through the End of Study visit.|Maximum Tolerated or Administrated Dose of MGD009 and MGA012","30 months|18 months","AUC|Cmax|Tmax|Ctrough|CL|Vss|t1/2|ADA|Anti-tumor activity","Area Under the Plasma Concentration versus Time Curve of MGD009 and MGA012|Maximum Plasma Concentration of MGD009 and MGA012|Time to reach maximum (peak) plasma concentration of MGD009 and MGA012|Trough plasma concentration of MGD009 and MGA012|Total body clearance of the drug from plasma of MGD009 and MGA012|Apparent volume of distribution at steady state of MGD009 and MGA012|Terminal half life of MGD009 and MGA012|Percent of patients with anti-drug antibody to MGD009 and MGA012|Conventional Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and immune-related response criteria (irRECIST)","30 months",{"$nulls":3},"Duarte, California, United States, 91010|Boston, Massachusetts, United States, 02214 Dana Farber Cancer InstituteBoston, Massachusetts, United States, 02215|Nashville, Tennessee, United States, 37203|Dallas, Texas, United States, 75251 University Of Texas Md Anderson Cancer CenterHouston, Texas, United States, 77030|Fairfax, Virginia, United States, 22031","California|Massachusetts|Tennessee|Texas|Virginia","United States","City Of Hope Medical Center|Massachusetts General Hospital|Sarah Cannon Research Institute|Mary Crowley Cancer Center|Virginia Cancer Specialists",{"$nulls":3},"Stacie Goldberg, MD","2018-12-20","2020-05-25T16:38:06.771","2020-05-26T17:10:42.972","NCT03406949"]
["5ecbf46d11702c1b1b916b12","NCT03406949","2019-03-07","MacroGenics","MGNX","Recruiting","MGD009/MGA012 Combination in Relapsed/Refractory Cancer","Mgd-009|Incmga00012|Mga-012",null,"Yes","['Mgd-009', 'Incmga00012', 'Mga-012']","Unknown",null,"Phase 1",1,139,"Anticipated","2018-02-27","2020-12-01",{"$nulls":5},"The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics (PK) pharmacodynamics and preliminary antitumor activity of MGD009 administered in combination with MGA012 in patients with B7-H3- expressing tumors.","This study is a Phase 1, open-label, dose escalation, and cohort expansion study designed to characterize the safety, tolerability, PK, pharmacodynamics, immunogenicity, and preliminary antitumor activity of the combination of MGD009 and MGA012, each of which is administered by IV infusion.The study consists of a Dose Escalation Phase to determine the Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) (if no MTD is defined) of the combination, followed by a Cohort Expansion Phase to further define the safety and initial antitumor activity of the combination with the doses established in the Dose Escalation Phase. Patients with B7-H3-expressing unresectable, locally advanced, or metastatic solid tumors of any histology will be enrolled in the Dose Escalation Phase. Following the establishment of an MTD, additional patients with specific tumor types will enroll in the Cohort Expansion Phase.","A Phase 1, Open Label, Dose Escalation Study of MGD009, a Humanized B7-H3 x CD3 DARTÂ® Protein, in Combination With MGA012, an Anti-PD-1 Antibody, in Patients With Relapsed or Refractory B7-H3-Expressing Tumors","CP-MGD009-02","Advanced Solid Tumors","Oncology Solid Tumor Unspecified|Oncology Unspecified","Oncology Solid Tumor|Oncology Unspecified","Oncology","Experimental","MGD009 + MGA012","B7-H3 x CD3 DART protein + anti-PD-1 antibody","Biological","MGD009|MGA012","B7-H3 x CD3 DART protein|anti-PD-1 antibody","orlotamab|INCMGA00012","MGD009 + MGA012","\n\n * Histologically-proven, unresectable locally advanced or metastatic solid tumors of any histology that test positive for B7-H3 expression on tumor cells or vasculature for whom no approved therapy with demonstrated clinical benefit is available. For all tumor types, the requirement for previous systemic therapy may be waived if a patient was intolerant of or refused standard first-line therapy\n * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n * Life expectancy â‰¥ 12 weeks\n * Measurable disease, with the exception of prostate cancer\n * Tissue specimen available for B7-H3 and PD-L1 expression testing\n * Acceptable laboratory parameters\n * Patients who have previously received an immune checkpoint inhibitor (e.g., anti- PD-L1, anti-PD-1, anti-CTLA-4) prior to enrollment must have toxicities related to the checkpoint inhibitor resolved to â‰¤ Grade 1 or baseline (prior to the checkpoint inhibitor) to be eligible for enrollment. Patients who experienced previous hypothyroidism toxicity on a checkpoint inhibitor are eligible to enter study regardless of Grade resolution as long as the patient is well controlled on thyroid replacement hormones.\n\n","\n\n * Patients with history of prior central nervous system (CNS) metastasis must have been treated, must be asymptomatic, and must not have any of the following at the time of enrollment: 1. No concurrent treatment for the CNS disease (e.g. surgery, radiation, corticosteroids >10 mg prednisone/day or equivalent)\n    2. No progression of CNS metastases on MRI or CT for at least 14 days after last day of prior therapy for the CNS metastases\n    3. No concurrent leptomeningeal disease or cord compression\n   \n   \n * Patients with any history of known or suspected autoimmune disease with the specific exceptions of vitiligo, resolved childhood atopic dermatitis, psoriasis not requiring systemic treatment (within the past 2 years), and patients with a history of Grave's disease that are now euthyroid clinically and by laboratory testing\n * Treatment with any, investigational therapy within the 4 weeks prior to the initiation of study drug administration\n * Treatment with any systemic chemotherapy within 3 weeks\n * Treatment with radiation therapy within 2 weeks\n * History of allogeneic bone marrow, stem-cell, or solid organ transplant\n * Treatment with systemic corticosteroids (> 10 mg per day prednisone or equivalent) or other immune suppressive drugs within 2 weeks\n * Clinically significant cardiovascular or pulmonary disease\n * Evidence of active viral, bacterial, or systemic fungal infection requiring parenteral treatment within 7 days prior to the initiation of study drug. Patients requiring any systemic antiviral, antifungal, or antibacterial therapy for active infection must have completed treatment no less than one week prior to the initiation of study drug.\n * Known history of positive testing for human immunodeficiency virus or history of acquired immune deficiency syndrome\n * Known history of hepatitis B or hepatitis C infection or known positive test for hepatitis B surface antigen, hepatitis B core antigen, or hepatitis C polymerase chain reaction",{"$nulls":4},"Actual","2018-01-23","Actual","Anticipated","2022-12-01","Anticipated","2019-03-01","2018-01-16","2018-01-16","2019-03-05","No",null,"Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":19},"Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v4.03|MTD/MAD","Safety is based on evaluation of adverse events (AEs) and serious adverse events (SAEs) from the time of study drug administration through the End of Study visit.|Maximum Tolerated or Administrated Dose of MGD009 and MGA012","30 months|18 months","AUC|Cmax|Tmax|Ctrough|CL|Vss|t1/2|ADA|Anti-tumor activity","Area Under the Plasma Concentration versus Time Curve of MGD009 and MGA012|Maximum Plasma Concentration of MGD009 and MGA012|Time to reach maximum (peak) plasma concentration of MGD009 and MGA012|Trough plasma concentration of MGD009 and MGA012|Total body clearance of the drug from plasma of MGD009 and MGA012|Apparent volume of distribution at steady state of MGD009 and MGA012|Terminal half life of MGD009 and MGA012|Percent of patients with anti-drug antibody to MGD009 and MGA012|Conventional Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and immune-related response criteria (irRECIST)","30 months","wortha@macrogenics.com","Amy Worth","(240) 660-0757","Duarte, California, United States, 91010|Boston, Massachusetts, United States, 02214|Grand Rapids, Michigan, United States, 49546|Nashville, Tennessee, United States, 37203|Dallas, Texas, United States, 75251|Fairfax, Virginia, United States, 22031","California|Massachusetts|Michigan|Tennessee|Texas|Virginia","United States","City Of Hope Medical Center|Massachusetts General Hospital|Start (South Texas Accelerated Research Therapeutics) - Midwest|Sarah Cannon Research Institute|Mary Crowley Cancer Center|Virginia Cancer Specialists",{"$nulls":3},"Stacie Goldberg, MD","2019-03-05","2020-05-25T16:38:05.086","2020-05-26T17:10:42.972","NCT03406949"]
["5ecbf46ce2561b1b11905dfc","NCT03406962","2018-01-23","Magenta Therapeutics","MGTA","Not yet recruiting","MGTA-456 in Patients With Inherited Metabolic Disorders Undergoing Hematopoietic Stem Cell Transplantation (HSCT)","Hsc-835",null,"Yes","['Hsc-835']","Unknown",null,"Phase 2",1,12,"Anticipated","2018-01-01","2019-05-01",{"$nulls":5},"This study is designed to assess the safety and efficacy of using MGTA-456 in patients with Inherited Metabolic Disorders (IMD) undergoing stem cell transplantation.","This phase 2 study is designed to evaluate the safety and efficacy of MGTA-456 after myeloablative conditioning to induce rapid and sustained hematopoietic engraftment with replacement of the specific protein product missing or defective in the patient with an IMD. The study aims to enhance the efficacy of umbilical cord blood transplantation (UCBT), to preserve neurodevelopment in patients with selected IMDs. Since MGTA-456 offers increased numbers of HSCs over standard UCB, it is expected to reduce the risks of prolonged neutropenia and thrombocytopenia and graft failure, and potentially transplant-related mortality (TRM). Patients with Hurler syndrome (also referred to as mucopolysaccharidosis-1H (MPS-1H)), cerebral adrenoleukodystrophy (cALD), metachromatic leukodystrophy (MLD) or globoid cell leukodystrophy (GLD) (also referred to as Krabbe disease) could be eligible for this study.","A Phase 2, Single-arm, Open-label Study to Evaluate the Safety and Efficacy of MGTA-456 in Patients With Inherited Metabolic Disorders (IMD) Undergoing Hematopoietic Stem Cell Transplantation (HSCT)","IMD-001","Inherited Metabolic Disorders (IMD)","Tic Disorders|Myelodysplastic Syndrome|Thrombocytopenia|Adrenoleukodystrophy|Leukodystrophy, Globoid Cell|Leukodystrophy, Metachromatic|Neutropenia|Mucopolysaccharidosis I|Mucopolysaccharidosis IV|Hematopoietic Stem Cell Transplant|Stem Cell Transplant","Neurodevelopmental Disorders|Hematologic Diseases|Central Nervous System Diseases|Genetic Diseases, Inborn|Organ Transplants","Central Nervous System|Heme & Lymph Diseases|Neonatal Diseases & Abnormalities|Organ Transplants","Experimental","MGTA-456","MGTA-456 is an expanded umbilical cord blood product used during single umbilical cord blood transplantation.","Drug","MGTA-456","Hematopoietic stem cell transplantation will be done with the cell therapy product MGTA-456.","HSC835","MGTA-456","\n\n * Diagnosed with Hurler syndrome, metachromatic leukodystrophy (MLD), globoid cell leukodystrophy (GLD or Krabbe) or cerebral adrenoleukodystrophy (cALD)\n * Adequate organ function\n * Availability of eligible donor material\n\n","\n\n * Availability of a matched-related donor who is not a carrier of the same genetic defect\n * Active infection at screening\n * Prior myeloablative conditioning\n * History of human immunodeficiency virus (HIV) infection",{"$nulls":4},"Actual","2018-01-23","Actual","Anticipated","2020-04-01","Anticipated","2018-01-01","2018-01-16","2018-01-16","2018-01-16","Yes","inherited metabolic disorders\ncerebral adrenoleukodystrophy\nHurler syndrome\ngloboid cell leukodystrophy\nKrabbe disease\nmetachromatic leukodystrophy\nhematopoietic stem cells\nhematopoietic stem cell transplant\numbilical cord blood\numbilical cord blood transplant\nMGTA-456\nmyeloablative conditioning regimen\nbone marrow transplant\nmucopolysaccharidosis-1H","Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A",null,"15 Years","All",null,"No","Undecided",{"$nulls":3},"Yes","No",{"$nulls":19},"Incidence of engraftment","Engraftment is defined as achieving an absolute neutrophil count (ANC) â‰¥0.5 Ã— 10â\u0081¹/L for 3 consecutive days.","42 days","Incidence of infusion toxicities","Incidence of MGTA-456-related adverse events (AEs) that limit MGTA-456 administration","48 hours","clinicaltrials@magentatx.com","Magenta Clinical Trials","857-242-0170","Minneapolis, Minnesota, United States, 55455","Minnesota","United States","University Of Minnesota",{"$nulls":3},"Magenta Study Director","2018-01-16","2020-05-25T16:38:04.468","2020-05-26T17:10:42.972","NCT03406962"]
["5ecbf46e307e3d1b1f8d9d95","NCT03406962","2018-02-22","Magenta Therapeutics","MGTA","Recruiting","MGTA-456 in Patients With Inherited Metabolic Disorders Undergoing Hematopoietic Stem Cell Transplantation (HSCT)","Hsc-835",null,"Yes","['Hsc-835']","Unknown",null,"Phase 2",1,12,"Anticipated","2018-02-01","2019-05-01",{"$nulls":5},"This study is designed to assess the safety and efficacy of using MGTA-456 in patients with Inherited Metabolic Disorders (IMD) undergoing stem cell transplantation.","This phase 2 study is designed to evaluate the safety and efficacy of MGTA-456 after myeloablative conditioning to induce rapid and sustained hematopoietic engraftment with replacement of the specific protein product missing or defective in the patient with an IMD. The study aims to enhance the efficacy of umbilical cord blood transplantation (UCBT), to preserve neurodevelopment in patients with selected IMDs. Since MGTA-456 offers increased numbers of HSCs over standard UCB, it is expected to reduce the risks of prolonged neutropenia and thrombocytopenia and graft failure, and potentially transplant-related mortality (TRM). Patients with Hurler syndrome (also referred to as mucopolysaccharidosis-1H (MPS-1H)), cerebral adrenoleukodystrophy (cALD), metachromatic leukodystrophy (MLD) or globoid cell leukodystrophy (GLD) (also referred to as Krabbe disease) could be eligible for this study.","A Phase 2, Single-arm, Open-label Study to Evaluate the Safety and Efficacy of MGTA-456 in Patients With Inherited Metabolic Disorders (IMD) Undergoing Hematopoietic Stem Cell Transplantation (HSCT)","IMD-001","Inherited Metabolic Disorders (IMD)","Tic Disorders|Myelodysplastic Syndrome|Thrombocytopenia|Adrenoleukodystrophy|Leukodystrophy, Globoid Cell|Leukodystrophy, Metachromatic|Neutropenia|Mucopolysaccharidosis I|Mucopolysaccharidosis IV|Hematopoietic Stem Cell Transplant|Stem Cell Transplant","Neurodevelopmental Disorders|Hematologic Diseases|Central Nervous System Diseases|Genetic Diseases, Inborn|Organ Transplants","Central Nervous System|Heme & Lymph Diseases|Neonatal Diseases & Abnormalities|Organ Transplants","Experimental","MGTA-456","MGTA-456 is an expanded umbilical cord blood product used during single umbilical cord blood transplantation.","Drug","MGTA-456","Hematopoietic stem cell transplantation will be done with the cell therapy product MGTA-456.","HSC835","MGTA-456","\n\n * Diagnosed with Hurler syndrome, metachromatic leukodystrophy (MLD), globoid cell leukodystrophy (GLD or Krabbe) or cerebral adrenoleukodystrophy (cALD)\n * Adequate organ function\n * Availability of eligible donor material\n\n","\n\n * Availability of a matched-related donor who is not a carrier of the same genetic defect\n * Active infection at screening\n * Prior myeloablative conditioning\n * History of human immunodeficiency virus (HIV) infection",{"$nulls":4},"Actual","2018-01-23","Actual","Anticipated","2020-04-01","Anticipated","2018-02-01","2018-01-16","2018-01-16","2018-02-20","Yes","inherited metabolic disorders\ncerebral adrenoleukodystrophy\nHurler syndrome\ngloboid cell leukodystrophy\nKrabbe disease\nmetachromatic leukodystrophy\nhematopoietic stem cells\nhematopoietic stem cell transplant\numbilical cord blood\numbilical cord blood transplant\nMGTA-456\nmyeloablative conditioning regimen\nbone marrow transplant\nmucopolysaccharidosis-1H","Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A",null,"15 Years","All",null,"No","Undecided",{"$nulls":3},"Yes","No",{"$nulls":19},"Incidence of engraftment","Engraftment is defined as achieving an absolute neutrophil count (ANC) â‰¥0.5 Ã— 10â\u0081¹/L for 3 consecutive days.","42 days","Incidence of infusion toxicities","Incidence of MGTA-456-related adverse events (AEs) that limit MGTA-456 administration","48 hours","clinicaltrials@magentatx.com","Magenta Clinical Trials","857-242-0170","Minneapolis, Minnesota, United States, 55455","Minnesota","United States","University Of Minnesota",{"$nulls":3},"Magenta Study Director","2018-02-20","2020-05-25T16:38:06.665","2020-05-26T17:10:42.972","NCT03406962"]
["5ecbf46e307e3d1b1f8d9d96","NCT03406962","2019-07-15","Magenta Therapeutics","MGTA","Recruiting","MGTA-456 in Patients With Inherited Metabolic Disorders Undergoing Hematopoietic Stem Cell Transplantation (HSCT)","Hsc-835",null,"Yes","['Hsc-835']","Unknown",null,"Phase 2",1,12,"Anticipated","2018-02-09","2020-03-01",{"$nulls":5},"This study is designed to assess the safety and efficacy of using MGTA-456 in patients with Inherited Metabolic Disorders (IMD) undergoing stem cell transplantation.","This phase 2 study is designed to evaluate the safety and efficacy of MGTA-456 in patients with IMD after receiving myeloablative conditioning and HSCT. MGTA-456 is an expanded CD34+ cell therapy product candidate given to induce rapid and sustained hematopoietic engraftment. In patients with selected IMDs, transplant is expected to replace defective or missing protein and preserve neurodevelopment. Since MGTA-456 offers increased numbers of HSCs over standard umbilical cord blood, it is expected to reduce the risks of prolonged neutropenia and thrombocytopenia and graft failure, and potentially transplant-related mortality (TRM). Patients with Hurler syndrome (also referred to as mucopolysaccharidosis-1H (MPS-1H)), cerebral adrenoleukodystrophy (cALD), metachromatic leukodystrophy (MLD) or globoid cell leukodystrophy (GLD) (also referred to as Krabbe disease) are eligible for this study.","A Phase 2, Single-arm, Open-label Study to Evaluate the Safety and Efficacy of MGTA-456 in Patients With Inherited Metabolic Disorders (IMD) Undergoing Hematopoietic Stem Cell Transplantation (HSCT)","IMD-001","Inherited Metabolic Disorders (IMD)","Tic Disorders|Myelodysplastic Syndrome|Thrombocytopenia|Adrenoleukodystrophy|Leukodystrophy, Globoid Cell|Leukodystrophy, Metachromatic|Neutropenia|Mucopolysaccharidosis I|Mucopolysaccharidosis IV|Hematopoietic Stem Cell Transplant|Stem Cell Transplant|Mucopolysaccharidosis VI","Neurodevelopmental Disorders|Hematologic Diseases|Central Nervous System Diseases|Genetic Diseases, Inborn|Organ Transplants","Central Nervous System|Heme & Lymph Diseases|Neonatal Diseases & Abnormalities|Organ Transplants","Experimental","MGTA-456","MGTA-456 is an expanded CD34+ cell therapy investigational product used in replacement of single umbilical cord blood transplantation.","Drug","MGTA-456","Hematopoietic stem cell transplantation will be done with the cell therapy product MGTA-456.","HSC835","MGTA-456","\n\n * Diagnosed with Hurler syndrome, metachromatic leukodystrophy (MLD), globoid cell leukodystrophy (GLD or Krabbe) or cerebral adrenoleukodystrophy (cALD)\n * Adequate organ function\n * Availability of eligible donor material\n\n","\n\n * Availability of a matched-related donor who is not a carrier of the same genetic defect\n * Active infection at screening\n * Prior myeloablative conditioning\n * History of human immunodeficiency virus (HIV) infection",{"$nulls":4},"Actual","2018-01-23","Actual","Anticipated","2021-01-01","Anticipated","2019-07-01","2018-01-16","2018-01-16","2019-07-11","Yes","inherited metabolic disorders\ncerebral adrenoleukodystrophy\nHurler syndrome\ngloboid cell leukodystrophy\nKrabbe disease\nmetachromatic leukodystrophy\nhematopoietic stem cells\nhematopoietic stem cell transplant\numbilical cord blood\numbilical cord blood transplant\nMGTA-456\nmyeloablative conditioning regimen\nbone marrow transplant\nmucopolysaccharidosis-1H","Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","6 Months","16 Years","All",null,"No","Undecided",{"$nulls":3},"Yes","No",{"$nulls":19},"Incidence of engraftment","Engraftment is defined as achieving an absolute neutrophil count (ANC) â‰¥0.5 Ã— 10â\u0081¹/L for 3 consecutive days.","42 days","Incidence of infusion toxicities","Incidence of MGTA-456-related adverse events (AEs) that limit MGTA-456 administration","48 hours","clinicaltrials@magentatx.com","Magenta Clinical Trials","857-242-0170","Atlanta, Georgia, United States, 30322|Minneapolis, Minnesota, United States, 55455|Durham, North Carolina, United States, 27710|Cincinnati, Ohio, United States, 45229","Georgia|Minnesota|North Carolina|Ohio","United States","Children's Healthcare Of Atlanta - Emory University|University Of Minnesota|Duke University|Cincinnati Children's Hospital Medical Center",{"$nulls":3},"Magenta Study Coordinator","2019-07-11","2020-05-25T16:38:06.854","2020-05-26T17:10:42.972","NCT03406962"]
["5ecbf471feab101b1553093b","NCT03407118","2018-03-07","Eli Lilly","LLY","Recruiting","A Study of LY900014 in Japanese Participants With Type 1 Diabetes Mellitus","Ly-900014|Insulin lispro","ODC Stimulant","Yes","['Ly-900014']","No",null,"Phase 1",2,40,"Anticipated","2018-02-17","2018-06-01","AUC","Area Under The Curve",{"$nulls":3},"This study will compare LY900014, a drug that lowers blood sugar, with insulin lispro (Humalog). Both drugs will be given by injection under the skin of the abdomen. This study will be conducted in participants with type 1 diabetes to investigate how quickly and how much LY900014 is absorbed and the effect of LY900014 on blood sugar levels in comparison with insulin lispro. The study will last about 3 to 6 weeks for each participant, not including screening.",null,"Pharmacokinetics and Glucodynamics of LY900014 Compared to Insulin Lispro (Humalog) Following Single Dose Administration in Japanese Patients With Type 1 Diabetes Mellitus",16645,"Diabetes Mellitus, Type 1","Type 1 Diabetes","Metabolic Diseases","Nutritional Disorders","Experimental|Active Comparator","LY900014|Insulin Lispro (Humalog)","LY900014 administered subcutaneously (SC) in one of two study periods.|Insulin lispro administered SC in one of two study periods.","Drug","LY900014|Insulin Lispro","Administered SC.","LY275585 | Humalog","LY900014|Insulin Lispro (Humalog)","\n\n * Are Japanese male or female participant with a diagnosis of T1DM, based on the World Health Organization classification, for at least 1 year prior to screening\n * Have a body mass index (BMI) of 18.5 to 30.0 kilograms per square meter (kg/mÂ²)\n * Have a glycated hemoglobin <9.0% at screening\n\n","\n\n * Have, except for current regimen of insulin therapy and concomitant medication(s), regular use of or intended use of any over-the-counter or prescription medications or nutritional supplements that treat hyperglycemia or insulin resistance or that promote weight loss within 14 days before dosing\n * Are receiving chronic (lasting longer than 14 consecutive days) systemic or inhaled glucocorticoid therapy (excluding topical, intra-articular, and intraocular preparations), or have received such therapy within the 4 weeks before screening\n * Have a history of renal impairment (exclusion only if estimated glomerular filtration rate [GFR] <60 milliliters/minute/1.73 square meters [GFR is estimated according to a formula recommended by the Japanese Society of Nephrology]), or have a serum creatinine level â‰¥126 micromoles per liter (Î¼mol/L) (>1.42 milligrams per deciliter [mg/dL]) (male) or â‰¥111 Î¼mol/L (>1.25 mg/dL) (female)\n * Have a history of deep vein thrombosis of the leg, or repeated episodes of deep leg vein thrombosis in first-degree relatives (parents, siblings, or children), as determined by the investigator\n * Have proliferative retinopathy or maculopathy and/or severe neuropathy; in particular, autonomic neuropathy, as determined by the investigator based on a recent (<1.5 years) ophthalmologic examination\n * Have had any significant changes in insulin regimen and/or unstable blood glucose control within the past 3 months prior to screening, as determined by the investigator\n * Require daily insulin treatment >1.5 units per kilogram (U/kg)",{"$nulls":4},"Actual","2018-01-23","Actual","Anticipated","2018-06-01","Anticipated","2018-03-01","2018-01-16","2018-01-17","2018-03-05","No",null,"Interventional","Basic Science","Crossover Assignment","Double (Participant, Investigator)","Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":4},"Yes",{"$nulls":12},"I8B-MC-ITRZ","Eli Lilly and Company","Pharmacokinetics (PK): Pharmacokinetics: Area Under the Plasma Concentration Curve (AUC) of Insulin Lispro for Each Treatment Arm","PK: AUC of Insulin Lispro for Each Treatment Arm","Predose through 10 hours post dose in each period","Total Amount of Glucose Infused (Gtot) Over Duration of Clamp for Each Treatment Arm","Gtot Over Duration of Clamp for Each Treatment Arm","Predose through 10 hours post dose in each period","Clinicaltrials.gov@Lilly.com","This is a single site clinical trial. 1-877-CTLILLY (1-877-285-4559) or","1-317-615-4559","Fukuoka, Japan, 812-0025",null,"Japan","For Additional Information Regarding Investigative Sites For This Trial, Contact 1-877-Ctlilly (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 Am To 5 Pm Eastern Time (Utc/Gmt - 5 Hours, Est) Or Speak With Your Personal Physician.",{"$nulls":3},"Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)","2018-03-05","2020-05-25T16:38:09.782","2020-05-26T17:10:42.972","NCT03407118"]
["5ecbf472fe30261b1a04830f","NCT03407118","2018-07-09","Eli Lilly","LLY","Active, not recruiting","A Study of LY900014 in Japanese Participants With Type 1 Diabetes Mellitus","Ly-900014|Insulin lispro","ODC Stimulant","Yes","['Ly-900014']","No",null,"Phase 1",2,40,"Actual","2018-02-17","2018-06-23","AUC","Area Under The Curve",{"$nulls":3},"This study will compare LY900014, a drug that lowers blood sugar, with insulin lispro (Humalog). Both drugs will be given by injection under the skin of the abdomen. This study will be conducted in participants with type 1 diabetes to investigate how quickly and how much LY900014 is absorbed and the effect of LY900014 on blood sugar levels in comparison with insulin lispro. The study will last about 3 to 6 weeks for each participant, not including screening.",null,"Pharmacokinetics and Glucodynamics of LY900014 Compared to Insulin Lispro (Humalog) Following Single Dose Administration in Japanese Patients With Type 1 Diabetes Mellitus",16645,"Diabetes Mellitus, Type 1","Type 1 Diabetes","Metabolic Diseases","Nutritional Disorders","Experimental|Active Comparator","LY900014|Insulin Lispro (Humalog)","LY900014 administered subcutaneously (SC) in one of two study periods.|Insulin lispro administered SC in one of two study periods.","Drug","LY900014|Insulin Lispro","Administered SC.","LY275585 | Humalog","LY900014|Insulin Lispro (Humalog)","\n\n * Are Japanese male or female participant with a diagnosis of T1DM, based on the World Health Organization classification, for at least 1 year prior to screening\n * Have a body mass index (BMI) of 18.5 to 30.0 kilograms per square meter (kg/mÂ²)\n * Have a glycated hemoglobin <9.0% at screening\n\n","\n\n * Have, except for current regimen of insulin therapy and concomitant medication(s), regular use of or intended use of any over-the-counter or prescription medications or nutritional supplements that treat hyperglycemia or insulin resistance or that promote weight loss within 14 days before dosing\n * Are receiving chronic (lasting longer than 14 consecutive days) systemic or inhaled glucocorticoid therapy (excluding topical, intra-articular, and intraocular preparations), or have received such therapy within the 4 weeks before screening\n * Have a history of renal impairment (exclusion only if estimated glomerular filtration rate [GFR] <60 milliliters/minute/1.73 square meters [GFR is estimated according to a formula recommended by the Japanese Society of Nephrology]), or have a serum creatinine level â‰¥126 micromoles per liter (Î¼mol/L) (>1.42 milligrams per deciliter [mg/dL]) (male) or â‰¥111 Î¼mol/L (>1.25 mg/dL) (female)\n * Have a history of deep vein thrombosis of the leg, or repeated episodes of deep leg vein thrombosis in first-degree relatives (parents, siblings, or children), as determined by the investigator\n * Have proliferative retinopathy or maculopathy and/or severe neuropathy; in particular, autonomic neuropathy, as determined by the investigator based on a recent (<1.5 years) ophthalmologic examination\n * Have had any significant changes in insulin regimen and/or unstable blood glucose control within the past 3 months prior to screening, as determined by the investigator\n * Require daily insulin treatment >1.5 units per kilogram (U/kg)",{"$nulls":4},"Actual","2018-01-23","Actual","Actual","2018-07-01","Anticipated","2018-07-01","2018-01-16","2018-01-17","2018-07-06","No",null,"Interventional","Basic Science","Crossover Assignment","Double (Participant, Investigator)","Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":4},"Yes",{"$nulls":12},"I8B-MC-ITRZ","Eli Lilly and Company","Pharmacokinetics (PK): Pharmacokinetics: Area Under the Plasma Concentration Curve (AUC) of Insulin Lispro for Each Treatment Arm","PK: AUC of Insulin Lispro for Each Treatment Arm","Predose through 10 hours post dose in each period","Total Amount of Glucose Infused (Gtot) Over Duration of Clamp for Each Treatment Arm","Gtot Over Duration of Clamp for Each Treatment Arm","Predose through 10 hours post dose in each period",{"$nulls":3},"Fukuoka, Japan, 812-0025",null,"Japan","For Additional Information Regarding Investigative Sites For This Trial, Contact 1-877-Ctlilly (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 Am To 5 Pm Eastern Time (Utc/Gmt - 5 Hours, Est) Or Speak With Your Personal Physician.",{"$nulls":3},"Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)","2018-07-06","2020-05-25T16:38:10.892","2020-05-26T17:10:42.972","NCT03407118"]
["5ecbf46efeab101b15530936","NCT03407144","2018-01-23","Merck","MRK","Not yet recruiting","Safety and Efficacy of Pembrolizumab (MK-3475) in Children and Young Adults With Classical Hodgkin Lymphoma (MK-3475-667/KEYNOTE-667)","Pembrolizumab|Doxorubicin|Vinblastine|Dacarbazine|Bleomycin|Cyclophosphamide|Vincristine|Prednisolone|Prednisone|Etoposide","PD-1 Inhibitor|TOP2 Inhibitor|Tubulin Inhibitor|Mitosis Inhibitor|P-gp Modulator|DNA Mtase Inhibitor|DNA Synthesis Inhibitor|Immunomodulator|Mitosis Inhibitor|Tubulin Inhibitor|GR Agonist|GR Agonist|Immunosuppressive","Yes","['Bleomycin']","Unknown",null,"Phase 2",2,400,"Anticipated","2018-02-23","2023-11-24","RR","Response Rate",{"$nulls":3},"This study will examine the safety and efficacy of pembrolizumab (MK-3475) in combination with chemotherapy in children and young adults with newly diagnosed classical Hodgkin Lymphoma (cHL) who are slow early responders (SERs) to frontline chemotherapy.","Group 1 will consist of low-risk participants with cHL Stages IA, IB and IIA without bulky disease. Group 2 will consist of high-risk participants with cHL Stages IIEB, IIIEA, IIIEB, IIIB, IVA and IVB.","An Open-label, Uncontrolled, Multicenter Phase II Trial of MK-3475 (Pembrolizumab) in Children and Young Adults With Newly Diagnosed Classical Hodgkin Lymphoma With Inadequate (Slow Early) Response to Frontline Chemotherapy (KEYNOTE 667)","3475-667","Hodgkin Lymphoma","Lymphoma","Oncology Hematological","Oncology","Experimental","Pembrolizumab + AVD (Group 1)|Pembrolizumab + COPDAC-28 (Group 2)","After receiving 2 4-week cycles of ABVD (doxorubicin, bleomycin, vinblastine and dacarbazine) induction therapy, SER participants in Group 1 will receive pembrolizumab 2 mg/kg up to a maximum of 200 mg (3 to 17 years of age) or 200 mg (18 to 25 years of age) on Day 1 of each 3-week cycle (Q3W) in combination with 2 cycles of AVD chemotherapy (doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2 and dacarbazine 375 mg/m^2 on Days 1 and 15; cycle frequency every 4 weeks [Q4W]). All SERs in Group 1 will receive radiotherapy (RT) after completing AVD chemotherapy.|After receiving 2 4-week cycles of OEPA (vincristine, etoposide/etopophos, prednisone/prednisolone and doxorubicin) induction therapy, SER participants in Group 2 will receive pembrolizumab 2 mg/kg up to a maximum of 200 mg (3 to 17 years of age) or 200 mg (18 to 25 years of age) Q3W, in combination with 4 cycles of COPDAC-28 chemotherapy (cyclophosphamide 500 mg/m^2 on Days 1 and 8, vincristine 1.5 mg/m^2 with maximum single dose 2 mg on Days 1 and 8, prednisone/prednisolone 40 mg/m^2/day divided in 3 doses on Days 1 to 15, dacarbazine 250 mg/m^2 on Days 1 to 3; cycle frequency Q4W). SERs in Group 2 will receive RT if they have a positive Positron Emission Tomography (PET) response after completing COPDAC-28 chemotherapy.","Biological|Drug","pembrolizumab|doxorubicin|vinblastine|dacarbazine|bleomycin|Radiation: radiotherapy|cyclophosphamide|vincristine|prednisone/prednisolone|etoposide","2 mg/kg intravenous (IV) up to a max of 200 mg (3 to 17 years of age) or 200 mg IV (18 to 25 years of age); cycle frequency Q3W|10 units/m^2 IV on Days 1 and 15 as part of ABVD induction therapy (cycle frequency: Q4W, Group 1)|21 Grays (Gy) with boosts to 30 Gy for PET-avid sites|500 mg/m^2 IV on days 1 and 8 as part of COPDAC-28 chemotherapy (cycle frequency: Q4W, Group 2)|1.5 mg/m^2 IV with maximum single dose 2 mg on Days 1, 8, and 15 as part of OEPA induction therapy (cycle frequency: Q4W, Group 2)|125 mg/m^2 IV on Days 1 to 5 as part of OEPA induction therapy (cycle frequency: Q4W, Group 2)","MK-3475|Etoposide Phosphate","Pembrolizumab + AVD (Group 1)|Pembrolizumab + COPDAC-28 (Group 2)","\n\n * Group 1: Must have newly diagnosed, pathologically confirmed cHL at Stages IA, IB and IIA without bulky disease. Group 2: Must have newly diagnosed, pathologically confirmed cHL at Stages IIEB, IIIEA,IIIEB, IIIB, IVA and IVB\n * Has measurable disease per investigator assessment\n * Male participants must agree to use approved contraception during the treatment period and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period\n * Female participants who are not pregnant or breastfeeding, and who are either not a woman of childbearing potential (WOCBP), or are a WOCBP who agrees to use approved contraception during the treatment period and for at least 120 days after the last dose of study treatment\n * Performance status: Lansky Play-Performance Scale â‰¥50 for children up to and including 16 years of age OR Karnofsky score â‰¥50 for participants >16 years of age\n * Has adequate organ function\n\n","\n\n * Has undergone solid organ transplant at any time, or prior allogeneic hematopoietic stem cell transplantation within the last 5 years\n * WOCBP who has a positive urine pregnancy test within 72 hours before the first dose of study treatment\n * Baseline left ventricular ejection fraction value <50% or shortening fraction of <27%\n * Has received prior therapy with an anti-Programmed Death (PD)-1, anti-Programmed Death-Ligand 1 (PD-L1), or anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor or has previously participated in a Merck pembrolizumab (MK-3475) clinical study\n * Has received any prior anti-cancer therapy, monoclonal antibody, chemotherapy, or an investigational agent or device before the first dose of study treatment, or has not recovered from AEs due to previously administered agents\n * Has received prior RT within 2 weeks of start of study treatment\n * Has received a live vaccine within 30 days prior to the first dose of study drug\n * Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment\n * Has a diagnosis of lymphocyte-predominant Hodgkin Lymphoma (HL)\n * Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy\n * Has a known additional malignancy that is progressing or requires active treatment\n * Has radiographically detectable central nervous system metastases and/or carcinomatous meningitis as assessed by local site investigator at the time of diagnosis\n * Has severe hypersensitivity (â‰¥Grade 3) to any study therapies including any excipients\n * Has an active autoimmune disease that has required systemic treatment in past 2 years\n * Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis\n * Has an active infection requiring systemic therapy\n * Has a known history of human immunodeficiency virus (HIV) infection\n * Has a known history of Hepatitis B or known active Hepatitis C virus infection\n * Has a known history of active tuberculosis\n * Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator\n * Has known psychiatric or substance abuse disorders that would interfere with cooperating with the requirements of the study\n * Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of trial treatment",{"$nulls":4},"Actual","2018-01-23","Actual","Anticipated","2023-11-24","Anticipated","2018-01-01","2018-01-17","2018-01-17","2018-01-17","No","Programmed Death-1 (PD-1)\nPD1\nProgrammed Death-Ligand 1 (PD-L1)\nPDL1","Interventional","Treatment","Parallel Assignment","None (Open Label)","Non-Randomized","3 Years","25 Years","All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"2017-001123-53|MK-3475-667","EudraCT Number|Merck Protocol Number","Objective Response Rate (ORR) According to International Working Group (IWG) Criteria as Assessed by Blinded Independent Central Review (BICR)","ORR is defined as the percentage of SER participants who have a Complete Response (","CR, disappearance of all evidence of disease) or Partial Response (","Rate of Positron Emission Tomography (PET) Scan Negativity|Event-Free Survival (EFS) According to IWG Criteria as Assessed by BICR in SER Participants|Overall Survival (OS) in SER Participants|Frequency of Radiotherapy (RT)|Adverse Events (AE)|Treatment Discontinuations Due to AEs","The rate of PET negativity is the percentage of participants with PET negativity, which is defined as Deauville score 1, 2 or 3, after 2 cycles of AVD or 2 or 4 cycles of COPDAC-28, in combination with pembrolizumab. The Deauville 5-point scoring system is an internationally accepted and utilized five-point scoring system for the Fluorodeoxyglucose (FDG) avidity of a Hodgkin's lymphoma or Non-Hodgkin's lymphoma tumor mass as seen on FDG PET scan: Score 1= No uptake above the background, Score 2= Uptake â‰¤ mediastinum, Score 3= Uptake > mediastinum but â‰¤ liver, Score 4= Uptake moderately increased compared to the liver at any site, Score 5= Uptake markedly increased compared to the liver at any site, Score X= New areas of uptake unlikely to be related to lymphoma. In the present study, scores of 1 and 2 are considered to be negative and scores of 3, 4, and 5 are considered to be positive.|EFS is defined as the time from study enrollment to the first documented progressive disease (PD) according to IWG or death due to any cause, whichever occurs first. Progression/disease recurrence will be determined by BICR using IWG criteria. EFS rate will be estimated from time of initial diagnosis in SER participants.|OS is defined as the time from study enrollment to death due to any cause. The OS rate will be estimated from the start of initial diagnosis in SER participants. Participants without documented death will be censored at the date of the last follow-up.|The frequency of RT received by eligible participants (positive PET response, i.e. Deauville score of 4 or 5) will be reported.|The number of participants who experience an AE will be reported for each arm. An AE is any untoward medical occurrence in a participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment.|The number of participants who discontinue study treatment due to an AE will be reported for each arm. An AE is any untoward medical occurrence in a participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment.","Up to 5 years",{"$nulls":10},"Medical Director","2018-01-17","2020-05-25T16:38:06.913","2020-05-26T17:10:42.972","NCT03407144"]
["5ecbf46efe30261b1a048306","NCT03407144","2018-02-07","Merck","MRK","Recruiting","Safety and Efficacy of Pembrolizumab (MK-3475) in Children and Young Adults With Classical Hodgkin Lymphoma (MK-3475-667/KEYNOTE-667)","Pembrolizumab|Doxorubicin|Vinblastine|Dacarbazine|Bleomycin|Cyclophosphamide|Vincristine|Prednisolone|Prednisone|Etoposide","PD-1 Inhibitor|TOP2 Inhibitor|Tubulin Inhibitor|Mitosis Inhibitor|P-gp Modulator|DNA Mtase Inhibitor|DNA Synthesis Inhibitor|Immunomodulator|Mitosis Inhibitor|Tubulin Inhibitor|GR Agonist|GR Agonist|Immunosuppressive","Yes","['Bleomycin']","Unknown",null,"Phase 2",2,400,"Anticipated","2018-02-23","2023-11-24","RR","Response Rate",{"$nulls":3},"This study will examine the safety and efficacy of pembrolizumab (MK-3475) in combination with chemotherapy in children and young adults with newly diagnosed classical Hodgkin Lymphoma (cHL) who are slow early responders (SERs) to frontline chemotherapy.","Group 1 will consist of low-risk participants with cHL Stages IA, IB and IIA without bulky disease. Group 2 will consist of high-risk participants with cHL Stages IIEB, IIIEA, IIIEB, IIIB, IVA and IVB.","An Open-label, Uncontrolled, Multicenter Phase II Trial of MK-3475 (Pembrolizumab) in Children and Young Adults With Newly Diagnosed Classical Hodgkin Lymphoma With Inadequate (Slow Early) Response to Frontline Chemotherapy (KEYNOTE 667)","3475-667","Hodgkin Lymphoma","Lymphoma","Oncology Hematological","Oncology","Experimental","Pembrolizumab + AVD (Group 1)|Pembrolizumab + COPDAC-28 (Group 2)","After receiving 2 4-week cycles of ABVD (doxorubicin, bleomycin, vinblastine and dacarbazine) induction therapy, SER participants in Group 1 will receive pembrolizumab 2 mg/kg up to a maximum of 200 mg (3 to 17 years of age) or 200 mg (18 to 25 years of age) on Day 1 of each 3-week cycle (Q3W) in combination with 2 cycles of AVD chemotherapy (doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2 and dacarbazine 375 mg/m^2 on Days 1 and 15; cycle frequency every 4 weeks [Q4W]). All SERs in Group 1 will receive radiotherapy (RT) after completing AVD chemotherapy.|After receiving 2 4-week cycles of OEPA (vincristine, etoposide/etopophos, prednisone/prednisolone and doxorubicin) induction therapy, SER participants in Group 2 will receive pembrolizumab 2 mg/kg up to a maximum of 200 mg (3 to 17 years of age) or 200 mg (18 to 25 years of age) Q3W, in combination with 4 cycles of COPDAC-28 chemotherapy (cyclophosphamide 500 mg/m^2 on Days 1 and 8, vincristine 1.5 mg/m^2 with maximum single dose 2 mg on Days 1 and 8, prednisone/prednisolone 40 mg/m^2/day divided in 3 doses on Days 1 to 15, dacarbazine 250 mg/m^2 on Days 1 to 3; cycle frequency Q4W). SERs in Group 2 will receive RT if they have a positive Positron Emission Tomography (PET) response after completing COPDAC-28 chemotherapy.","Biological|Drug","pembrolizumab|doxorubicin|vinblastine|dacarbazine|bleomycin|Radiation: radiotherapy|cyclophosphamide|vincristine|prednisone/prednisolone|etoposide","2 mg/kg intravenous (IV) up to a max of 200 mg (3 to 17 years of age) or 200 mg IV (18 to 25 years of age); cycle frequency Q3W|10 units/m^2 IV on Days 1 and 15 as part of ABVD induction therapy (cycle frequency: Q4W, Group 1)|21 Grays (Gy) with boosts to 30 Gy for PET-avid sites|500 mg/m^2 IV on days 1 and 8 as part of COPDAC-28 chemotherapy (cycle frequency: Q4W, Group 2)|1.5 mg/m^2 IV with maximum single dose 2 mg on Days 1, 8, and 15 as part of OEPA induction therapy (cycle frequency: Q4W, Group 2)|125 mg/m^2 IV on Days 1 to 5 as part of OEPA induction therapy (cycle frequency: Q4W, Group 2)","MK-3475|Etoposide Phosphate","Pembrolizumab + AVD (Group 1)|Pembrolizumab + COPDAC-28 (Group 2)","\n\n * Group 1: Must have newly diagnosed, pathologically confirmed cHL at Stages IA, IB and IIA without bulky disease. Group 2: Must have newly diagnosed, pathologically confirmed cHL at Stages IIEB, IIIEA,IIIEB, IIIB, IVA and IVB\n * Has measurable disease per investigator assessment\n * Male participants must agree to use approved contraception during the treatment period and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period\n * Female participants who are not pregnant or breastfeeding, and who are either not a woman of childbearing potential (WOCBP), or are a WOCBP who agrees to use approved contraception during the treatment period and for at least 120 days after the last dose of study treatment\n * Performance status: Lansky Play-Performance Scale â‰¥50 for children up to and including 16 years of age OR Karnofsky score â‰¥50 for participants >16 years of age\n * Has adequate organ function\n\n","\n\n * Has undergone solid organ transplant at any time, or prior allogeneic hematopoietic stem cell transplantation within the last 5 years\n * WOCBP who has a positive urine pregnancy test within 72 hours before the first dose of study treatment\n * Baseline left ventricular ejection fraction value <50% or shortening fraction of <27%\n * Has received prior therapy with an anti-Programmed Death (PD)-1, anti-Programmed Death-Ligand 1 (PD-L1), or anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor or has previously participated in a Merck pembrolizumab (MK-3475) clinical study\n * Has received any prior anti-cancer therapy, monoclonal antibody, chemotherapy, or an investigational agent or device before the first dose of study treatment, or has not recovered from AEs due to previously administered agents\n * Has received prior RT within 2 weeks of start of study treatment\n * Has received a live vaccine within 30 days prior to the first dose of study drug\n * Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment\n * Has a diagnosis of lymphocyte-predominant Hodgkin Lymphoma (HL)\n * Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy\n * Has a known additional malignancy that is progressing or requires active treatment\n * Has radiographically detectable central nervous system metastases and/or carcinomatous meningitis as assessed by local site investigator at the time of diagnosis\n * Has severe hypersensitivity (â‰¥Grade 3) to any study therapies including any excipients\n * Has an active autoimmune disease that has required systemic treatment in past 2 years\n * Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis\n * Has an active infection requiring systemic therapy\n * Has a known history of human immunodeficiency virus (HIV) infection\n * Has a known history of Hepatitis B or known active Hepatitis C virus infection\n * Has a known history of active tuberculosis\n * Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator\n * Has known psychiatric or substance abuse disorders that would interfere with cooperating with the requirements of the study\n * Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of trial treatment",{"$nulls":4},"Actual","2018-01-23","Actual","Anticipated","2023-11-24","Anticipated","2018-02-01","2018-01-17","2018-01-17","2018-02-06","No","Programmed Death-1 (PD-1)\nPD1\nProgrammed Death-Ligand 1 (PD-L1)\nPDL1","Interventional","Treatment","Parallel Assignment","None (Open Label)","Non-Randomized","3 Years","25 Years","All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"2017-001123-53|MK-3475-667","EudraCT Number|Merck Protocol Number","Objective Response Rate (ORR) According to International Working Group (IWG) Criteria as Assessed by Blinded Independent Central Review (BICR)","ORR is defined as the percentage of SER participants who have a Complete Response (","CR, disappearance of all evidence of disease) or Partial Response (","Rate of Positron Emission Tomography (PET) Scan Negativity|Event-Free Survival (EFS) According to IWG Criteria as Assessed by BICR in SER Participants|Overall Survival (OS) in SER Participants|Frequency of Radiotherapy (RT)|Adverse Events (AE)|Treatment Discontinuations Due to AEs","The rate of PET negativity is the percentage of participants with PET negativity, which is defined as Deauville score 1, 2 or 3, after 2 cycles of AVD or 2 or 4 cycles of COPDAC-28, in combination with pembrolizumab. The Deauville 5-point scoring system is an internationally accepted and utilized five-point scoring system for the Fluorodeoxyglucose (FDG) avidity of a Hodgkin's lymphoma or Non-Hodgkin's lymphoma tumor mass as seen on FDG PET scan: Score 1= No uptake above the background, Score 2= Uptake â‰¤ mediastinum, Score 3= Uptake > mediastinum but â‰¤ liver, Score 4= Uptake moderately increased compared to the liver at any site, Score 5= Uptake markedly increased compared to the liver at any site, Score X= New areas of uptake unlikely to be related to lymphoma. In the present study, scores of 1 and 2 are considered to be negative and scores of 3, 4, and 5 are considered to be positive.|EFS is defined as the time from study enrollment to the first documented progressive disease (PD) according to IWG or death due to any cause, whichever occurs first. Progression/disease recurrence will be determined by BICR using IWG criteria. EFS rate will be estimated from time of initial diagnosis in SER participants.|OS is defined as the time from study enrollment to death due to any cause. The OS rate will be estimated from the start of initial diagnosis in SER participants. Participants without documented death will be censored at the date of the last follow-up.|The frequency of RT received by eligible participants (positive PET response, i.e. Deauville score of 4 or 5) will be reported.|The number of participants who experience an AE will be reported for each arm. An AE is any untoward medical occurrence in a participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment.|The number of participants who discontinue study treatment due to an AE will be reported for each arm. An AE is any untoward medical occurrence in a participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment.","Up to 5 years","Trialsites@merck.com","Toll Free Number","1-888-577-8839","Greenville, South Carolina, United States, 29607","South Carolina","United States","St. Francis Hospital Cancer Center ( Site 0001)",{"$nulls":3},"Medical Director","2018-02-06","2020-05-25T16:38:06.884","2020-05-26T17:10:42.972","NCT03407144"]
["5ecbf46efeab101b15530935","NCT03407144","2018-03-15","Merck","MRK","Recruiting","Safety and Efficacy of Pembrolizumab (MK-3475) in Children and Young Adults With Classical Hodgkin Lymphoma (MK-3475-667/KEYNOTE-667)","Pembrolizumab|Doxorubicin|Vinblastine|Dacarbazine|Bleomycin|Cyclophosphamide|Vincristine|Prednisolone|Prednisone|Etoposide","PD-1 Inhibitor|TOP2 Inhibitor|Tubulin Inhibitor|Mitosis Inhibitor|P-gp Modulator|DNA Mtase Inhibitor|DNA Synthesis Inhibitor|Immunomodulator|Mitosis Inhibitor|Tubulin Inhibitor|GR Agonist|GR Agonist|Immunosuppressive","Yes","['Bleomycin']","Unknown",null,"Phase 2",2,400,"Anticipated","2018-03-19","2023-11-24","RR","Response Rate",{"$nulls":3},"This study will examine the safety and efficacy of pembrolizumab (MK-3475) in combination with chemotherapy in children and young adults with newly diagnosed classical Hodgkin Lymphoma (cHL) who are slow early responders (SERs) to frontline chemotherapy.","Group 1 will consist of low-risk participants with cHL Stages IA, IB and IIA without bulky disease. Group 2 will consist of high-risk participants with cHL Stages IIEB, IIIEA, IIIEB, IIIB, IVA and IVB.","An Open-label, Uncontrolled, Multicenter Phase II Trial of MK-3475 (Pembrolizumab) in Children and Young Adults With Newly Diagnosed Classical Hodgkin Lymphoma With Inadequate (Slow Early) Response to Frontline Chemotherapy (KEYNOTE 667)","3475-667","Hodgkin Lymphoma","Lymphoma","Oncology Hematological","Oncology","Experimental","Pembrolizumab + AVD (Group 1)|Pembrolizumab + COPDAC-28 (Group 2)","After receiving 2 4-week cycles of ABVD (doxorubicin, bleomycin, vinblastine and dacarbazine) induction therapy, SER participants in Group 1 will receive pembrolizumab 2 mg/kg up to a maximum of 200 mg (3 to 17 years of age) or 200 mg (18 to 25 years of age) on Day 1 of each 3-week cycle (Q3W) in combination with 2 cycles of AVD chemotherapy (doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2 and dacarbazine 375 mg/m^2 on Days 1 and 15; cycle frequency every 4 weeks [Q4W]). All SERs in Group 1 will receive radiotherapy (RT) after completing AVD chemotherapy.|After receiving 2 4-week cycles of OEPA (vincristine, etoposide/etopophos, prednisone/prednisolone and doxorubicin) induction therapy, SER participants in Group 2 will receive pembrolizumab 2 mg/kg up to a maximum of 200 mg (3 to 17 years of age) or 200 mg (18 to 25 years of age) Q3W, in combination with 4 cycles of COPDAC-28 chemotherapy (cyclophosphamide 500 mg/m^2 on Days 1 and 8, vincristine 1.5 mg/m^2 with maximum single dose 2 mg on Days 1 and 8, prednisone/prednisolone 40 mg/m^2/day divided in 3 doses on Days 1 to 15, dacarbazine 250 mg/m^2 on Days 1 to 3; cycle frequency Q4W). SERs in Group 2 will receive RT if they have a positive Positron Emission Tomography (PET) response after completing COPDAC-28 chemotherapy.","Biological|Drug","pembrolizumab|doxorubicin|vinblastine|dacarbazine|bleomycin|Radiation: radiotherapy|cyclophosphamide|vincristine|prednisone/prednisolone|etoposide","2 mg/kg intravenous (IV) up to a max of 200 mg (3 to 17 years of age) or 200 mg IV (18 to 25 years of age); cycle frequency Q3W|10 units/m^2 IV on Days 1 and 15 as part of ABVD induction therapy (cycle frequency: Q4W, Group 1)|21 Grays (Gy) with boosts to 30 Gy for PET-avid sites|500 mg/m^2 IV on days 1 and 8 as part of COPDAC-28 chemotherapy (cycle frequency: Q4W, Group 2)|1.5 mg/m^2 IV with maximum single dose 2 mg on Days 1, 8, and 15 as part of OEPA induction therapy (cycle frequency: Q4W, Group 2)|125 mg/m^2 IV on Days 1 to 5 as part of OEPA induction therapy (cycle frequency: Q4W, Group 2)","MK-3475|Etoposide Phosphate","Pembrolizumab + AVD (Group 1)|Pembrolizumab + COPDAC-28 (Group 2)","\n\n * Group 1: Must have newly diagnosed, pathologically confirmed cHL at Stages IA, IB and IIA without bulky disease. Group 2: Must have newly diagnosed, pathologically confirmed cHL at Stages IIEB, IIIEA,IIIEB, IIIB, IVA and IVB\n * Has measurable disease per investigator assessment\n * Male participants must agree to use approved contraception during the treatment period and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period\n * Female participants who are not pregnant or breastfeeding, and who are either not a woman of childbearing potential (WOCBP), or are a WOCBP who agrees to use approved contraception during the treatment period and for at least 120 days after the last dose of study treatment\n * Performance status: Lansky Play-Performance Scale â‰¥50 for children up to and including 16 years of age OR Karnofsky score â‰¥50 for participants >16 years of age\n * Has adequate organ function\n\n","\n\n * Has undergone solid organ transplant at any time, or prior allogeneic hematopoietic stem cell transplantation within the last 5 years\n * WOCBP who has a positive urine pregnancy test within 72 hours before the first dose of study treatment\n * Baseline left ventricular ejection fraction value <50% or shortening fraction of <27%\n * Has received prior therapy with an anti-Programmed Death (PD)-1, anti-Programmed Death-Ligand 1 (PD-L1), or anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor or has previously participated in a Merck pembrolizumab (MK-3475) clinical study\n * Has received any prior anti-cancer therapy, monoclonal antibody, chemotherapy, or an investigational agent or device before the first dose of study treatment, or has not recovered from AEs due to previously administered agents\n * Has received prior RT within 2 weeks of start of study treatment\n * Has received a live vaccine within 30 days prior to the first dose of study drug\n * Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment\n * Has a diagnosis of lymphocyte-predominant Hodgkin Lymphoma (HL)\n * Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy\n * Has a known additional malignancy that is progressing or requires active treatment\n * Has radiographically detectable central nervous system metastases and/or carcinomatous meningitis as assessed by local site investigator at the time of diagnosis\n * Has severe hypersensitivity (â‰¥Grade 3) to any study therapies including any excipients\n * Has an active autoimmune disease that has required systemic treatment in past 2 years\n * Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis\n * Has an active infection requiring systemic therapy\n * Has a known history of human immunodeficiency virus (HIV) infection\n * Has a known history of Hepatitis B or known active Hepatitis C virus infection\n * Has a known history of active tuberculosis\n * Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator\n * Has known psychiatric or substance abuse disorders that would interfere with cooperating with the requirements of the study\n * Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of trial treatment",{"$nulls":4},"Actual","2018-01-23","Actual","Anticipated","2023-11-24","Anticipated","2018-03-01","2018-01-17","2018-01-17","2018-03-14","No","Programmed Death-1 (PD-1)\nPD1\nProgrammed Death-Ligand 1 (PD-L1)\nPDL1","Interventional","Treatment","Parallel Assignment","None (Open Label)","Non-Randomized","3 Years","25 Years","All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"2017-001123-53|MK-3475-667","EudraCT Number|Merck Protocol Number","Objective Response Rate (ORR) According to International Working Group (IWG) Criteria as Assessed by Blinded Independent Central Review (BICR)","ORR is defined as the percentage of SER participants who have a Complete Response (","CR, disappearance of all evidence of disease) or Partial Response (","Rate of Positron Emission Tomography (PET) Scan Negativity|Event-Free Survival (EFS) According to IWG Criteria as Assessed by BICR in SER Participants|Overall Survival (OS) in SER Participants|Frequency of Radiotherapy (RT)|Adverse Events (AE)|Treatment Discontinuations Due to AEs","The rate of PET negativity is the percentage of participants with PET negativity, which is defined as Deauville score 1, 2 or 3, after 2 cycles of AVD or 2 or 4 cycles of COPDAC-28, in combination with pembrolizumab. The Deauville 5-point scoring system is an internationally accepted and utilized five-point scoring system for the Fluorodeoxyglucose (FDG) avidity of a Hodgkin's lymphoma or Non-Hodgkin's lymphoma tumor mass as seen on FDG PET scan: Score 1= No uptake above the background, Score 2= Uptake â‰¤ mediastinum, Score 3= Uptake > mediastinum but â‰¤ liver, Score 4= Uptake moderately increased compared to the liver at any site, Score 5= Uptake markedly increased compared to the liver at any site, Score X= New areas of uptake unlikely to be related to lymphoma. In the present study, scores of 1 and 2 are considered to be negative and scores of 3, 4, and 5 are considered to be positive.|EFS is defined as the time from study enrollment to the first documented progressive disease (PD) according to IWG or death due to any cause, whichever occurs first. Progression/disease recurrence will be determined by BICR using IWG criteria. EFS rate will be estimated from time of initial diagnosis in SER participants.|OS is defined as the time from study enrollment to death due to any cause. The OS rate will be estimated from the start of initial diagnosis in SER participants. Participants without documented death will be censored at the date of the last follow-up.|The frequency of RT received by eligible participants (positive PET response, i.e. Deauville score of 4 or 5) will be reported.|The number of participants who experience an AE will be reported for each arm. An AE is any untoward medical occurrence in a participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment.|The number of participants who discontinue study treatment due to an AE will be reported for each arm. An AE is any untoward medical occurrence in a participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment.","Up to 5 years","Trialsites@merck.com","Toll Free Number","1-888-577-8839","Detroit, Michigan, United States, 48201|Greenville, South Carolina, United States, 29607","Michigan|South Carolina","United States","Karmanos Cancer Institute ( Site 0002)|St. Francis Hospital Cancer Center ( Site 0001)",{"$nulls":3},"Medical Director","2018-03-14","2020-05-25T16:38:06.857","2020-05-26T17:10:42.972","NCT03407144"]
["5ecbf46f307e3d1b1f8d9d98","NCT03407144","2018-06-25","Merck","MRK","Recruiting","Safety and Efficacy of Pembrolizumab (MK-3475) in Children and Young Adults With Classical Hodgkin Lymphoma (MK-3475-667/KEYNOTE-667)","Pembrolizumab|Doxorubicin|Vinblastine|Dacarbazine|Bleomycin|Cyclophosphamide|Vincristine|Prednisolone|Prednisone|Etoposide","PD-1 Inhibitor|TOP2 Inhibitor|Tubulin Inhibitor|Mitosis Inhibitor|P-gp Modulator|DNA Mtase Inhibitor|DNA Synthesis Inhibitor|Immunomodulator|Mitosis Inhibitor|Tubulin Inhibitor|GR Agonist|GR Agonist|Immunosuppressive","Yes","['Bleomycin']","Unknown",null,"Phase 2",2,400,"Anticipated","2018-04-09","2023-11-24","RR","Response Rate",{"$nulls":3},"This study will examine the safety and efficacy of pembrolizumab (MK-3475) in combination with chemotherapy in children and young adults with newly diagnosed classical Hodgkin Lymphoma (cHL) who are slow early responders (SERs) to frontline chemotherapy.","Group 1 will consist of low-risk participants with cHL Stages IA, IB and IIA without bulky disease. Group 2 will consist of high-risk participants with cHL Stages IIEB, IIIEA, IIIEB, IIIB, IVA and IVB.","An Open-label, Uncontrolled, Multicenter Phase II Trial of MK-3475 (Pembrolizumab) in Children and Young Adults With Newly Diagnosed Classical Hodgkin Lymphoma With Inadequate (Slow Early) Response to Frontline Chemotherapy (KEYNOTE 667)","3475-667","Hodgkin Lymphoma","Lymphoma","Oncology Hematological","Oncology","Experimental","Pembrolizumab + AVD (Group 1)|Pembrolizumab + COPDAC-28 (Group 2)","After receiving 2 4-week cycles of ABVD (doxorubicin, bleomycin, vinblastine and dacarbazine) induction therapy, SER participants in Group 1 will receive pembrolizumab 2 mg/kg up to a maximum of 200 mg (3 to 17 years of age) or 200 mg (18 to 25 years of age) on Day 1 of each 3-week cycle (Q3W) in combination with 2 cycles of AVD chemotherapy (doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2 and dacarbazine 375 mg/m^2 on Days 1 and 15; cycle frequency every 4 weeks [Q4W]). All SERs in Group 1 will receive radiotherapy (RT) after completing AVD chemotherapy.|After receiving 2 4-week cycles of OEPA (vincristine, etoposide/etopophos, prednisone/prednisolone and doxorubicin) induction therapy, SER participants in Group 2 will receive pembrolizumab 2 mg/kg up to a maximum of 200 mg (3 to 17 years of age) or 200 mg (18 to 25 years of age) Q3W, in combination with 4 cycles of COPDAC-28 chemotherapy (cyclophosphamide 500 mg/m^2 on Days 1 and 8, vincristine 1.5 mg/m^2 with maximum single dose 2 mg on Days 1 and 8, prednisone/prednisolone 40 mg/m^2/day divided in 3 doses on Days 1 to 15, dacarbazine 250 mg/m^2 on Days 1 to 3; cycle frequency Q4W). SERs in Group 2 will receive RT if they have a positive Positron Emission Tomography (PET) response after completing COPDAC-28 chemotherapy.","Biological|Drug","pembrolizumab|doxorubicin|vinblastine|dacarbazine|bleomycin|Radiation: radiotherapy|cyclophosphamide|vincristine|prednisone/prednisolone|etoposide","2 mg/kg intravenous (IV) up to a max of 200 mg (3 to 17 years of age) or 200 mg IV (18 to 25 years of age); cycle frequency Q3W|10 units/m^2 IV on Days 1 and 15 as part of ABVD induction therapy (cycle frequency: Q4W, Group 1)|21 Grays (Gy) with boosts to 30 Gy for PET-avid sites|500 mg/m^2 IV on days 1 and 8 as part of COPDAC-28 chemotherapy (cycle frequency: Q4W, Group 2)|1.5 mg/m^2 IV with maximum single dose 2 mg on Days 1, 8, and 15 as part of OEPA induction therapy (cycle frequency: Q4W, Group 2)|125 mg/m^2 IV on Days 1 to 5 as part of OEPA induction therapy (cycle frequency: Q4W, Group 2)","MK-3475|Etoposide Phosphate","Pembrolizumab + AVD (Group 1)|Pembrolizumab + COPDAC-28 (Group 2)","\n\n * Group 1: Must have newly diagnosed, pathologically confirmed cHL at Stages IA, IB and IIA without bulky disease. Group 2: Must have newly diagnosed, pathologically confirmed cHL at Stages IIEB, IIIEA,IIIEB, IIIB, IVA and IVB\n * Has measurable disease per investigator assessment\n * Male participants must agree to use approved contraception during the treatment period and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period\n * Female participants who are not pregnant or breastfeeding, and who are either not a woman of childbearing potential (WOCBP), or are a WOCBP who agrees to use approved contraception during the treatment period and for at least 120 days after the last dose of study treatment\n * Performance status: Lansky Play-Performance Scale â‰¥50 for children up to and including 16 years of age OR Karnofsky score â‰¥50 for participants >16 years of age\n * Has adequate organ function\n\n","\n\n * Has undergone solid organ transplant at any time, or prior allogeneic hematopoietic stem cell transplantation within the last 5 years\n * WOCBP who has a positive urine pregnancy test within 72 hours before the first dose of study treatment\n * Baseline left ventricular ejection fraction value <50% or shortening fraction of <27%\n * Has received prior therapy with an anti-Programmed Death (PD)-1, anti-Programmed Death-Ligand 1 (PD-L1), or anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor or has previously participated in a Merck pembrolizumab (MK-3475) clinical study\n * Has received any prior anti-cancer therapy, monoclonal antibody, chemotherapy, or an investigational agent or device before the first dose of study treatment, or has not recovered from AEs due to previously administered agents\n * Has received prior RT within 2 weeks of start of study treatment\n * Has received a live vaccine within 30 days prior to the first dose of study drug\n * Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment\n * Has a diagnosis of lymphocyte-predominant Hodgkin Lymphoma (HL)\n * Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy\n * Has a known additional malignancy that is progressing or requires active treatment\n * Has radiographically detectable central nervous system metastases and/or carcinomatous meningitis as assessed by local site investigator at the time of diagnosis\n * Has severe hypersensitivity (â‰¥Grade 3) to any study therapies including any excipients\n * Has an active autoimmune disease that has required systemic treatment in past 2 years\n * Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis\n * Has an active infection requiring systemic therapy\n * Has a known history of human immunodeficiency virus (HIV) infection\n * Has a known history of Hepatitis B or known active Hepatitis C virus infection\n * Has a known history of active tuberculosis\n * Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator\n * Has known psychiatric or substance abuse disorders that would interfere with cooperating with the requirements of the study\n * Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of trial treatment",{"$nulls":4},"Actual","2018-01-23","Actual","Anticipated","2023-11-24","Anticipated","2018-06-01","2018-01-17","2018-01-17","2018-06-21","No","Programmed Death-1 (PD-1)\nPD1\nProgrammed Death-Ligand 1 (PD-L1)\nPDL1","Interventional","Treatment","Parallel Assignment","None (Open Label)","Non-Randomized","3 Years","25 Years","All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"2017-001123-53|MK-3475-667","EudraCT Number|Merck Protocol Number","Objective Response Rate (ORR) According to International Working Group (IWG) Criteria as Assessed by Blinded Independent Central Review (BICR)","ORR is defined as the percentage of SER participants who have a Complete Response (","CR, disappearance of all evidence of disease) or Partial Response (","Rate of Positron Emission Tomography (PET) Scan Negativity|Event-Free Survival (EFS) According to IWG Criteria as Assessed by BICR in SER Participants|Overall Survival (OS) in SER Participants|Frequency of Radiotherapy (RT)|Adverse Events (AE)|Treatment Discontinuations Due to AEs","The rate of PET negativity is the percentage of participants with PET negativity, which is defined as Deauville score 1, 2 or 3, after 2 cycles of AVD or 2 or 4 cycles of COPDAC-28, in combination with pembrolizumab. The Deauville 5-point scoring system is an internationally accepted and utilized five-point scoring system for the Fluorodeoxyglucose (FDG) avidity of a Hodgkin's lymphoma or Non-Hodgkin's lymphoma tumor mass as seen on FDG PET scan: Score 1= No uptake above the background, Score 2= Uptake â‰¤ mediastinum, Score 3= Uptake > mediastinum but â‰¤ liver, Score 4= Uptake moderately increased compared to the liver at any site, Score 5= Uptake markedly increased compared to the liver at any site, Score X= New areas of uptake unlikely to be related to lymphoma. In the present study, scores of 1 and 2 are considered to be negative and scores of 3, 4, and 5 are considered to be positive.|EFS is defined as the time from study enrollment to the first documented progressive disease (PD) according to IWG or death due to any cause, whichever occurs first. Progression/disease recurrence will be determined by BICR using IWG criteria. EFS rate will be estimated from time of initial diagnosis in SER participants.|OS is defined as the time from study enrollment to death due to any cause. The OS rate will be estimated from the start of initial diagnosis in SER participants. Participants without documented death will be censored at the date of the last follow-up.|The frequency of RT received by eligible participants (positive PET response, i.e. Deauville score of 4 or 5) will be reported.|The number of participants who experience an AE will be reported for each arm. An AE is any untoward medical occurrence in a participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment.|The number of participants who discontinue study treatment due to an AE will be reported for each arm. An AE is any untoward medical occurrence in a participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment.","Up to 5 years","Trialsites@merck.com","Toll Free Number","1-888-577-8839","Detroit, Michigan, United States, 48201|Greenville, South Carolina, United States, 29607","Michigan|South Carolina","United States","Karmanos Cancer Institute ( Site 0002)|St. Francis Hospital Cancer Center ( Site 0001)",{"$nulls":3},"Medical Director","2018-06-21","2020-05-25T16:38:07.831","2020-05-26T17:10:42.972","NCT03407144"]
["5ecbf46ffe30261b1a048308","NCT03407144","2019-10-04","Merck","MRK","Recruiting","Safety and Efficacy of Pembrolizumab (MK-3475) in Children and Young Adults With Classical Hodgkin Lymphoma (MK-3475-667/KEYNOTE-667)","Pembrolizumab|Doxorubicin|Vinblastine|Dacarbazine|Bleomycin|Cyclophosphamide|Vincristine|Prednisolone|Prednisone|Etoposide","PD-1 Inhibitor|TOP2 Inhibitor|Tubulin Inhibitor|Mitosis Inhibitor|P-gp Modulator|DNA Mtase Inhibitor|DNA Synthesis Inhibitor|Immunomodulator|Mitosis Inhibitor|Tubulin Inhibitor|GR Agonist|GR Agonist|Immunosuppressive","Yes","['Bleomycin']","Unknown",null,"Phase 2",2,440,"Anticipated","2018-04-09","2027-02-13","RR","Response Rate",{"$nulls":3},"This study will examine the safety and efficacy of pembrolizumab (MK-3475) in combination with chemotherapy in children and young adults with newly diagnosed classical Hodgkin Lymphoma (cHL) who are slow early responders (SERs) to frontline chemotherapy.","Group 1 will consist of low-risk participants with cHL Stages IA, IB and IIA without bulky disease. Group 2 will consist of high-risk participants with cHL Stages IIEB, IIIEA, IIIEB, IIIB, IVA and IVB.","An Open-label, Uncontrolled, Multicenter Phase II Trial of MK-3475 (Pembrolizumab) in Children and Young Adults With Newly Diagnosed Classical Hodgkin Lymphoma With Inadequate (Slow Early) Response to Frontline Chemotherapy (KEYNOTE 667)","3475-667","Hodgkin Lymphoma","Lymphoma","Oncology Hematological","Oncology","Experimental","Pembrolizumab + AVD (Group 1)|Pembrolizumab + COPDAC-28 (Group 2)","After receiving two 4-week cycles of ABVD (doxorubicin, bleomycin, vinblastine and dacarbazine) induction therapy, SER participants in Group 1 will receive pembrolizumab 2 mg/kg up to a maximum of 200 mg (3 to 17 years of age) or 200 mg (18 to 25 years of age) on Day 1 of each 3-week cycle (Q3W) in combination with two cycles of AVD chemotherapy (doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2 and dacarbazine 375 mg/m^2 on Days 1 and 15; cycle frequency every 4 weeks [Q4W]). All SERs in Group 1 will receive radiotherapy (RT) after completing AVD chemotherapy.|After receiving two 4-week cycles of OEPA (vincristine, etoposide/etopophos, prednisone/prednisolone and doxorubicin) induction therapy, SER participants in Group 2 will receive pembrolizumab 2 mg/kg up to a maximum of 200 mg (3 to 17 years of age) or 200 mg (18 to 25 years of age) Q3W, in combination with 4 cycles of COPDAC-28 chemotherapy (cyclophosphamide 500 mg/m^2 on Days 1 and 8, vincristine 1.5 mg/m^2 with maximum single dose 2 mg on Days 1 and 8, prednisone/prednisolone 40 mg/m^2/day divided in 3 doses on Days 1 to 15, dacarbazine 250 mg/m^2 on Days 1 to 3; cycle frequency Q4W). SERs in Group 2 will receive RT if they have a positive Positron Emission Tomography (PET) response after completing COPDAC-28 chemotherapy.","Biological|Drug","pembrolizumab|doxorubicin|vinblastine|dacarbazine|bleomycin|Radiation: Radiotherapy (RT)|cyclophosphamide|vincristine|prednisone/prednisolone|etoposide","2 mg/kg intravenous (IV) up to a max of 200 mg (3 to 17 years of age) or 200 mg IV (18 to 25 years of age); cycle frequency Q3W|10 units/m^2 IV on Days 1 and 15 as part of ABVD induction therapy (cycle frequency: Q4W, Group 1)|RT administered daily, dose dependent on randomization group and disease response.|500 mg/m^2 IV on days 1 and 8 as part of COPDAC-28 chemotherapy (cycle frequency: Q4W, Group 2)|125 mg/m^2 IV on Days 1 to 5 as part of OEPA induction therapy (cycle frequency: Q4W, Group 2)","MK-3475|Etoposide Phosphate","Pembrolizumab + AVD (Group 1)|Pembrolizumab + COPDAC-28 (Group 2)","\n\n * Group 1: Must have newly diagnosed, pathologically confirmed cHL at Stages IA, IB and IIA without bulky disease. Group 2: Must have newly diagnosed, pathologically confirmed cHL at Stages IIEB, IIIEA,IIIEB, IIIB, IVA and IVB\n * Has measurable disease per investigator assessment\n * Male participants must agree to use approved contraception during the treatment period and for at least 120 days (or longer, if required by the drug label of chemotherapy received by the participant on study) after the last dose of study treatment and refrain from donating sperm during this period\n * Female participants who are not pregnant or breastfeeding, and who are either not a woman of childbearing potential (WOCBP), or are a WOCBP who agrees to use approved contraception during the treatment period and for at least 120 days (or longer, if required by the drug label of chemotherapy received by the participant on study) after the last dose of study treatment\n * Performance status: Lansky Play-Performance Scale â‰¥50 for children up to and including 16 years of age OR Karnofsky score â‰¥50 for participants >16 years of age\n * Has adequate organ function\n\n","\n\n * Has undergone solid organ transplant at any time, or prior allogeneic hematopoietic stem cell transplantation within the last 5 years\n * WOCBP who has a positive urine pregnancy test within 72 hours before the first dose of study treatment\n * Baseline left ventricular ejection fraction value <50% or shortening fraction of <27%\n * Has received prior therapy with an anti-Programmed Death (PD)-1, anti-Programmed Death-Ligand 1 (PD-L1), or anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor or has previously participated in a Merck pembrolizumab (MK-3475) clinical study\n * Has received any prior anti-cancer therapy, monoclonal antibody, chemotherapy, or an investigational agent or device before the first dose of study treatment, or has not recovered from AEs due to previously administered agents\n * Has received a live vaccine within 30 days prior to the first dose of pembrolizumab\n * Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment\n * Has a diagnosis of lymphocyte-predominant Hodgkin Lymphoma (HL)\n * Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of pembrolizumab\n * Has a known additional malignancy that is progressing or requires active treatment\n * Has radiographically detectable central nervous system metastases and/or carcinomatous meningitis as assessed by local site investigator at the time of diagnosis\n * Has severe hypersensitivity (â‰¥Grade 3) to any study therapies including any excipients\n * Has an active autoimmune disease that has required systemic treatment in past 2 years\n * Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis\n * Has an active infection requiring systemic therapy\n * Has a known history of human immunodeficiency virus (HIV) infection\n * Has a known history of Hepatitis B or known active Hepatitis C virus infection\n * Has a known history of active tuberculosis\n * Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator\n * Has known psychiatric or substance abuse disorders that would interfere with cooperating with the requirements of the study\n * Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days (or longer, if required by the drug label of chemotherapy received by the participant on study) after the last dose of trial treatment",{"$nulls":4},"Actual","2018-01-23","Actual","Anticipated","2027-02-13","Anticipated","2019-10-01","2018-01-17","2018-01-17","2019-10-03","No","Programmed Death-1 (PD-1)\nPD1\nProgrammed Death-Ligand 1 (PD-L1)\nPDL1","Interventional","Treatment","Parallel Assignment","None (Open Label)","Non-Randomized","3 Years","25 Years","All",null,"No","Yes\nhttp://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf",{"$nulls":3},"Yes","No",{"$nulls":17},"2017-001123-53|MK-3475-667","EudraCT Number|Merck Protocol Number","Objective Response Rate (ORR) in SER Participants By Risk Group (Low, High) as Assessed by Blinded Independent Central Review (BICR)","ORR is defined as the percentage of SER participants who have a Complete Response (","CR, disappearance of all evidence of disease) or Partial Response (","Rate of Positron Emission Tomography (PET) Scan Negativity in SER Participants By Risk Group (Low, High) After AVD or COPDAC-28 Chemotherapy|Event-Free Survival (EFS) in SER Participants By Risk Group (Low, High) as Assessed by BICR|Overall Survival (OS) in SER Participants By Risk Group (Low, High)|Exposure to Radiotherapy (RT) in SER Participants By Risk Group (Low, High)|Rate of PET Scan Negativity In Group 1 Participants After ABVD Induction Therapy|EFS in Rapid Early Responder (RER) Participants By Risk Group (Low, High) as Assessed by Investigator|OS in RER Participants By Risk Group (Low, High)|Serum Thymus and Activation-Regulated Chemokine (TARC) Levels in SER Participants By Risk Group (Low, High)|Number of SER Participants Experiencing an Adverse Event (AE) By Risk Group (Low, High)|Number of SER Participants Discontinuing Study Treatment Due to AEs By Risk Group (Low, High)","The rate of PET negativity for SER participants is the percentage of participants with PET negativity (defined as Deauville score 1, 2 or 3) after two cycles of AVD (Group 1) or four cycles of COPDAC-28 (Group 2), in combination with pembrolizumab. The Deauville 5-point scoring system is an internationally accepted and utilized five-point scoring system for the Fluorodeoxyglucose (FDG) avidity of a Hodgkin's lymphoma or Non-Hodgkin's lymphoma tumor mass as seen on FDG PET scan: Score 1= No uptake above the background, Score 2= Uptake â‰¤ mediastinum, Score 3= Uptake > mediastinum but â‰¤ liver, Score 4= Uptake moderately increased compared to the liver at any site, Score 5= Uptake markedly increased compared to the liver at any site or new lesions, Score X= New areas of uptake unlikely to be related to lymphoma. In the present study, scores of 1, 2 and 3 are considered to be negative and scores of 4 and 5 are considered to be positive.|EFS is defined as the time from study enrollment to the first documented disease progression or recurrence, or death due to any cause, whichever occurs first. Progression/disease recurrence will be determined by BICR using IWG criteria.|OS is defined as the time from study enrollment to death due to any cause. Participants without documented death will be censored at the date of the last follow-up.|The frequency of RT received by eligible participants (positive PET response, i.e. Deauville score of 4 or 5) will be reported.|The rate of PET negativity for Group 1 participants is the percentage of participants with PET negativity (defined as Deauville score 1, 2 or 3) after two cycles of ABVD induction. The Deauville 5-point scoring system is an internationally accepted and utilized five-point scoring system for the FDG avidity of a Hodgkin's lymphoma or Non-Hodgkin's lymphoma tumor mass as seen on FDG PET scan: Score 1= No uptake above the background, Score 2= Uptake â‰¤ mediastinum, Score 3= Uptake > mediastinum but â‰¤ liver, Score 4= Uptake moderately increased compared to the liver at any site, Score 5= Uptake markedly increased compared to the liver at any site or new lesions, Score X= New areas of uptake unlikely to be related to lymphoma. In the present study, scores of 1, 2 and 3 are considered to be negative and scores of 4 and 5 are considered to be positive.|EFS is defined as the time from study enrollment to the first documented disease progression or recurrence, or death due to any cause, whichever occurs first. Progression/disease recurrence will be determined by the investigator.|Serum TARC levels will be measured and evaluated as a potential biomarker in SER participants by risk group at screening, early, and late response assessments.|An AE is any untoward medical occurrence in a participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. The number of SER participants who experience an AE will be reported for each arm.|An AE is any untoward medical occurrence in a participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. The number of SER participants who discontinue study treatment due to an AE will be reported for each arm.","Up to 5 years","Trialsites@merck.com","Toll Free Number","1-888-577-8839","Barcelona, Spain, 08035|Detroit, Michigan, United States, 48201|Greenville, South Carolina, United States, 29607","Michigan|South Carolina","Spain|United States","Hospital Universitari Vall D Hebron ( Site 0432)|Karmanos Cancer Institute ( Site 0002)|St. Francis Hospital Cancer Center ( Site 0001)",{"$nulls":3},"Medical Director","2019-10-03","2020-05-25T16:38:07.959","2020-05-26T17:10:42.972","NCT03407144"]
["5ecbf470e2561b1b11905e02","NCT03407144","2019-10-24","Merck","MRK","Recruiting","Safety and Efficacy of Pembrolizumab (MK-3475) in Children and Young Adults With Classical Hodgkin Lymphoma (MK-3475-667/KEYNOTE-667)","Pembrolizumab|Doxorubicin|Vinblastine|Dacarbazine|Bleomycin|Cyclophosphamide|Vincristine|Prednisolone|Prednisone|Etoposide","PD-1 Inhibitor|TOP2 Inhibitor|Tubulin Inhibitor|Mitosis Inhibitor|P-gp Modulator|DNA Mtase Inhibitor|DNA Synthesis Inhibitor|Immunomodulator|Mitosis Inhibitor|Tubulin Inhibitor|GR Agonist|GR Agonist|Immunosuppressive","Yes","['Bleomycin']","Unknown",null,"Phase 2",2,440,"Anticipated","2018-04-09","2027-02-13","RR","Response Rate",{"$nulls":3},"This study will examine the safety and efficacy of pembrolizumab (MK-3475) in combination with chemotherapy in children and young adults with newly diagnosed classical Hodgkin Lymphoma (cHL) who are slow early responders (SERs) to frontline chemotherapy.","Group 1 will consist of low-risk participants with cHL Stages IA, IB and IIA without bulky disease. Group 2 will consist of high-risk participants with cHL Stages IIEB, IIIEA, IIIEB, IIIB, IVA and IVB.","An Open-label, Uncontrolled, Multicenter Phase II Trial of MK-3475 (Pembrolizumab) in Children and Young Adults With Newly Diagnosed Classical Hodgkin Lymphoma With Inadequate (Slow Early) Response to Frontline Chemotherapy (KEYNOTE 667)","3475-667","Hodgkin Lymphoma","Lymphoma","Oncology Hematological","Oncology","Experimental","Pembrolizumab + AVD (Group 1)|Pembrolizumab + COPDAC-28 (Group 2)","After receiving two 4-week cycles of ABVD (doxorubicin, bleomycin, vinblastine and dacarbazine) induction therapy, SER participants in Group 1 will receive pembrolizumab 2 mg/kg up to a maximum of 200 mg (3 to 17 years of age) or 200 mg (18 to 25 years of age) on Day 1 of each 3-week cycle (Q3W) in combination with two cycles of AVD chemotherapy (doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2 and dacarbazine 375 mg/m^2 on Days 1 and 15; cycle frequency every 4 weeks [Q4W]). All SERs in Group 1 will receive radiotherapy (RT) after completing AVD chemotherapy.|After receiving two 4-week cycles of OEPA (vincristine, etoposide/etopophos, prednisone/prednisolone and doxorubicin) induction therapy, SER participants in Group 2 will receive pembrolizumab 2 mg/kg up to a maximum of 200 mg (3 to 17 years of age) or 200 mg (18 to 25 years of age) Q3W, in combination with 4 cycles of COPDAC-28 chemotherapy (cyclophosphamide 500 mg/m^2 on Days 1 and 8, vincristine 1.5 mg/m^2 with maximum single dose 2 mg on Days 1 and 8, prednisone/prednisolone 40 mg/m^2/day divided in 3 doses on Days 1 to 15, dacarbazine 250 mg/m^2 on Days 1 to 3; cycle frequency Q4W). SERs in Group 2 will receive RT if they have a positive Positron Emission Tomography (PET) response after completing COPDAC-28 chemotherapy.","Biological|Drug","pembrolizumab|doxorubicin|vinblastine|dacarbazine|bleomycin|Radiation: Radiotherapy (RT)|cyclophosphamide|vincristine|prednisone/prednisolone|etoposide","2 mg/kg intravenous (IV) up to a max of 200 mg (3 to 17 years of age) or 200 mg IV (18 to 25 years of age); cycle frequency Q3W|10 units/m^2 IV on Days 1 and 15 as part of ABVD induction therapy (cycle frequency: Q4W, Group 1)|RT administered daily, dose dependent on randomization group and disease response.|500 mg/m^2 IV on days 1 and 8 as part of COPDAC-28 chemotherapy (cycle frequency: Q4W, Group 2)|125 mg/m^2 IV on Days 1 to 5 as part of OEPA induction therapy (cycle frequency: Q4W, Group 2)","MK-3475|Etoposide Phosphate","Pembrolizumab + AVD (Group 1)|Pembrolizumab + COPDAC-28 (Group 2)","\n\n * Group 1: Must have newly diagnosed, pathologically confirmed cHL at Stages IA, IB and IIA without bulky disease. Group 2: Must have newly diagnosed, pathologically confirmed cHL at Stages IIEB, IIIEA,IIIEB, IIIB, IVA and IVB\n * Has measurable disease per investigator assessment\n * Male participants must agree to use approved contraception during the treatment period and for at least 120 days (or longer, if required by the drug label of chemotherapy received by the participant on study) after the last dose of study treatment and refrain from donating sperm during this period\n * Female participants who are not pregnant or breastfeeding, and who are either not a woman of childbearing potential (WOCBP), or are a WOCBP who agrees to use approved contraception during the treatment period and for at least 120 days (or longer, if required by the drug label of chemotherapy received by the participant on study) after the last dose of study treatment\n * Performance status: Lansky Play-Performance Scale â‰¥50 for children up to and including 16 years of age OR Karnofsky score â‰¥50 for participants >16 years of age\n * Has adequate organ function\n\n","\n\n * Has undergone solid organ transplant at any time, or prior allogeneic hematopoietic stem cell transplantation within the last 5 years\n * WOCBP who has a positive urine pregnancy test within 72 hours before the first dose of study treatment\n * Baseline left ventricular ejection fraction value <50% or shortening fraction of <27%\n * Has received prior therapy with an anti-Programmed Death (PD)-1, anti-Programmed Death-Ligand 1 (PD-L1), or anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor or has previously participated in a Merck pembrolizumab (MK-3475) clinical study\n * Has received any prior anti-cancer therapy, monoclonal antibody, chemotherapy, or an investigational agent or device before the first dose of study treatment, or has not recovered from AEs due to previously administered agents\n * Has received a live vaccine within 30 days prior to the first dose of pembrolizumab\n * Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment\n * Has a diagnosis of lymphocyte-predominant Hodgkin Lymphoma (HL)\n * Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of pembrolizumab\n * Has a known additional malignancy that is progressing or requires active treatment\n * Has radiographically detectable central nervous system metastases and/or carcinomatous meningitis as assessed by local site investigator at the time of diagnosis\n * Has severe hypersensitivity (â‰¥Grade 3) to any study therapies including any excipients\n * Has an active autoimmune disease that has required systemic treatment in past 2 years\n * Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis\n * Has an active infection requiring systemic therapy\n * Has a known history of human immunodeficiency virus (HIV) infection\n * Has a known history of Hepatitis B or known active Hepatitis C virus infection\n * Has a known history of active tuberculosis\n * Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator\n * Has known psychiatric or substance abuse disorders that would interfere with cooperating with the requirements of the study\n * Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days (or longer, if required by the drug label of chemotherapy received by the participant on study) after the last dose of trial treatment",{"$nulls":4},"Actual","2018-01-23","Actual","Anticipated","2027-02-13","Anticipated","2019-10-01","2018-01-17","2018-01-17","2019-10-23","No","Programmed Death-1 (PD-1)\nPD1\nProgrammed Death-Ligand 1 (PD-L1)\nPDL1","Interventional","Treatment","Parallel Assignment","None (Open Label)","Non-Randomized","3 Years","25 Years","All",null,"No","Yes\nhttp://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf",{"$nulls":3},"Yes","No",{"$nulls":17},"2017-001123-53|MK-3475-667","EudraCT Number|Merck Protocol Number","Objective Response Rate (ORR) in SER Participants By Risk Group (Low, High) as Assessed by Blinded Independent Central Review (BICR)","ORR is defined as the percentage of SER participants who have a Complete Response (","CR, disappearance of all evidence of disease) or Partial Response (","Rate of Positron Emission Tomography (PET) Scan Negativity in SER Participants By Risk Group (Low, High) After AVD or COPDAC-28 Chemotherapy|Event-Free Survival (EFS) in SER Participants By Risk Group (Low, High) as Assessed by BICR|Overall Survival (OS) in SER Participants By Risk Group (Low, High)|Exposure to Radiotherapy (RT) in SER Participants By Risk Group (Low, High)|Rate of PET Scan Negativity In Group 1 Participants After ABVD Induction Therapy|EFS in Rapid Early Responder (RER) Participants By Risk Group (Low, High) as Assessed by Investigator|OS in RER Participants By Risk Group (Low, High)|Serum Thymus and Activation-Regulated Chemokine (TARC) Levels in SER Participants By Risk Group (Low, High)|Number of SER Participants Experiencing an Adverse Event (AE) By Risk Group (Low, High)|Number of SER Participants Discontinuing Study Treatment Due to AEs By Risk Group (Low, High)","The rate of PET negativity for SER participants is the percentage of participants with PET negativity (defined as Deauville score 1, 2 or 3) after two cycles of AVD (Group 1) or four cycles of COPDAC-28 (Group 2), in combination with pembrolizumab. The Deauville 5-point scoring system is an internationally accepted and utilized five-point scoring system for the Fluorodeoxyglucose (FDG) avidity of a Hodgkin's lymphoma or Non-Hodgkin's lymphoma tumor mass as seen on FDG PET scan: Score 1= No uptake above the background, Score 2= Uptake â‰¤ mediastinum, Score 3= Uptake > mediastinum but â‰¤ liver, Score 4= Uptake moderately increased compared to the liver at any site, Score 5= Uptake markedly increased compared to the liver at any site or new lesions, Score X= New areas of uptake unlikely to be related to lymphoma. In the present study, scores of 1, 2 and 3 are considered to be negative and scores of 4 and 5 are considered to be positive.|EFS is defined as the time from study enrollment to the first documented disease progression or recurrence, or death due to any cause, whichever occurs first. Progression/disease recurrence will be determined by BICR using IWG criteria.|OS is defined as the time from study enrollment to death due to any cause. Participants without documented death will be censored at the date of the last follow-up.|The frequency of RT received by eligible participants (positive PET response, i.e. Deauville score of 4 or 5) will be reported.|The rate of PET negativity for Group 1 participants is the percentage of participants with PET negativity (defined as Deauville score 1, 2 or 3) after two cycles of ABVD induction. The Deauville 5-point scoring system is an internationally accepted and utilized five-point scoring system for the FDG avidity of a Hodgkin's lymphoma or Non-Hodgkin's lymphoma tumor mass as seen on FDG PET scan: Score 1= No uptake above the background, Score 2= Uptake â‰¤ mediastinum, Score 3= Uptake > mediastinum but â‰¤ liver, Score 4= Uptake moderately increased compared to the liver at any site, Score 5= Uptake markedly increased compared to the liver at any site or new lesions, Score X= New areas of uptake unlikely to be related to lymphoma. In the present study, scores of 1, 2 and 3 are considered to be negative and scores of 4 and 5 are considered to be positive.|EFS is defined as the time from study enrollment to the first documented disease progression or recurrence, or death due to any cause, whichever occurs first. Progression/disease recurrence will be determined by the investigator.|Serum TARC levels will be measured and evaluated as a potential biomarker in SER participants by risk group at screening, early, and late response assessments.|An AE is any untoward medical occurrence in a participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. The number of SER participants who experience an AE will be reported for each arm.|An AE is any untoward medical occurrence in a participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. The number of SER participants who discontinue study treatment due to an AE will be reported for each arm.","Up to 5 years","Trialsites@merck.com","Toll Free Number","1-888-577-8839","Praha 5, Czechia, 150 06|Barcelona, Spain, 08035|Hollywood, Florida, United States, 33021|Detroit, Michigan, United States, 48201|Greenville, South Carolina, United States, 29607","Florida|Michigan|South Carolina","Czechia|Spain|United States","Fakultni Nemocnice V Motole ( Site 0356)|Hospital Universitari Vall D Hebron ( Site 0432)|Memorial Regional Hospital/Joe Dimaggio Children's Hospital ( Site 0048)|Karmanos Cancer Institute ( Site 0002)|St. Francis Hospital Cancer Center ( Site 0001)",{"$nulls":3},"Medical Director","2019-10-23","2020-05-25T16:38:08.022","2020-05-26T17:10:42.972","NCT03407144"]
["5ecbf47011702c1b1b916b17","NCT03407144","2019-12-06","Merck","MRK","Recruiting","Safety and Efficacy of Pembrolizumab (MK-3475) in Children and Young Adults With Classical Hodgkin Lymphoma (MK-3475-667/KEYNOTE-667)","Pembrolizumab|Doxorubicin|Vinblastine|Dacarbazine|Bleomycin|Cyclophosphamide|Vincristine|Prednisolone|Prednisone|Etoposide","PD-1 Inhibitor|TOP2 Inhibitor|Tubulin Inhibitor|Mitosis Inhibitor|P-gp Modulator|DNA Mtase Inhibitor|DNA Synthesis Inhibitor|Immunomodulator|Mitosis Inhibitor|Tubulin Inhibitor|GR Agonist|GR Agonist|Immunosuppressive","Yes","['Bleomycin']","Unknown",null,"Phase 2",2,440,"Anticipated","2018-04-09","2027-02-13","RR","Response Rate",{"$nulls":3},"This study will examine the safety and efficacy of pembrolizumab (MK-3475) in combination with chemotherapy in children and young adults with newly diagnosed classical Hodgkin Lymphoma (cHL) who are slow early responders (SERs) to frontline chemotherapy.","Group 1 will consist of low-risk participants with cHL Stages IA, IB and IIA without bulky disease. Group 2 will consist of high-risk participants with cHL Stages IIEB, IIIEA, IIIEB, IIIB, IVA and IVB.","An Open-label, Uncontrolled, Multicenter Phase II Trial of MK-3475 (Pembrolizumab) in Children and Young Adults With Newly Diagnosed Classical Hodgkin Lymphoma With Inadequate (Slow Early) Response to Frontline Chemotherapy (KEYNOTE 667)","3475-667","Hodgkin Lymphoma","Lymphoma","Oncology Hematological","Oncology","Experimental","Pembrolizumab + AVD (Group 1)|Pembrolizumab + COPDAC-28 (Group 2)","After receiving two 4-week cycles of ABVD (doxorubicin, bleomycin, vinblastine and dacarbazine) induction therapy, SER participants in Group 1 will receive pembrolizumab 2 mg/kg up to a maximum of 200 mg (3 to 17 years of age) or 200 mg (18 to 25 years of age) on Day 1 of each 3-week cycle (Q3W) in combination with two cycles of AVD chemotherapy (doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2 and dacarbazine 375 mg/m^2 on Days 1 and 15; cycle frequency every 4 weeks [Q4W]). All SERs in Group 1 will receive radiotherapy (RT) after completing AVD chemotherapy.|After receiving two 4-week cycles of OEPA (vincristine, etoposide/etopophos, prednisone/prednisolone and doxorubicin) induction therapy, SER participants in Group 2 will receive pembrolizumab 2 mg/kg up to a maximum of 200 mg (3 to 17 years of age) or 200 mg (18 to 25 years of age) Q3W, in combination with 4 cycles of COPDAC-28 chemotherapy (cyclophosphamide 500 mg/m^2 on Days 1 and 8, vincristine 1.5 mg/m^2 with maximum single dose 2 mg on Days 1 and 8, prednisone/prednisolone 40 mg/m^2/day divided in 3 doses on Days 1 to 15, dacarbazine 250 mg/m^2 on Days 1 to 3; cycle frequency Q4W). SERs in Group 2 will receive RT if they have a positive Positron Emission Tomography (PET) response after completing COPDAC-28 chemotherapy.","Biological|Drug","pembrolizumab|doxorubicin|vinblastine|dacarbazine|bleomycin|Radiation: Radiotherapy (RT)|cyclophosphamide|vincristine|prednisone/prednisolone|etoposide","2 mg/kg intravenous (IV) up to a max of 200 mg (3 to 17 years of age) or 200 mg IV (18 to 25 years of age); cycle frequency Q3W|10 units/m^2 IV on Days 1 and 15 as part of ABVD induction therapy (cycle frequency: Q4W, Group 1)|RT administered daily, dose dependent on randomization group and disease response.|500 mg/m^2 IV on days 1 and 8 as part of COPDAC-28 chemotherapy (cycle frequency: Q4W, Group 2)|125 mg/m^2 IV on Days 1 to 5 as part of OEPA induction therapy (cycle frequency: Q4W, Group 2)","MK-3475|Etoposide Phosphate","Pembrolizumab + AVD (Group 1)|Pembrolizumab + COPDAC-28 (Group 2)","\n\n * Group 1: Must have newly diagnosed, pathologically confirmed cHL at Stages IA, IB and IIA without bulky disease. Group 2: Must have newly diagnosed, pathologically confirmed cHL at Stages IIEB, IIIEA,IIIEB, IIIB, IVA and IVB\n * Has measurable disease per investigator assessment\n * Male participants must agree to use approved contraception during the treatment period and for at least 120 days (or longer, if required by the drug label of chemotherapy received by the participant on study) after the last dose of study treatment and refrain from donating sperm during this period\n * Female participants who are not pregnant or breastfeeding, and who are either not a woman of childbearing potential (WOCBP), or are a WOCBP who agrees to use approved contraception during the treatment period and for at least 120 days (or longer, if required by the drug label of chemotherapy received by the participant on study) after the last dose of study treatment\n * Performance status: Lansky Play-Performance Scale â‰¥50 for children up to and including 16 years of age OR Karnofsky score â‰¥50 for participants >16 years of age\n * Has adequate organ function\n\n","\n\n * Has undergone solid organ transplant at any time, or prior allogeneic hematopoietic stem cell transplantation within the last 5 years\n * WOCBP who has a positive urine pregnancy test within 72 hours before the first dose of study treatment\n * Baseline left ventricular ejection fraction value <50% or shortening fraction of <27%\n * Has received prior therapy with an anti-Programmed Death (PD)-1, anti-Programmed Death-Ligand 1 (PD-L1), or anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor or has previously participated in a Merck pembrolizumab (MK-3475) clinical study\n * Has received any prior anti-cancer therapy, monoclonal antibody, chemotherapy, or an investigational agent or device before the first dose of study treatment, or has not recovered from AEs due to previously administered agents\n * Has received a live vaccine within 30 days prior to the first dose of pembrolizumab\n * Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment\n * Has a diagnosis of lymphocyte-predominant Hodgkin Lymphoma (HL)\n * Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of pembrolizumab\n * Has a known additional malignancy that is progressing or requires active treatment\n * Has radiographically detectable central nervous system metastases and/or carcinomatous meningitis as assessed by local site investigator at the time of diagnosis\n * Has severe hypersensitivity (â‰¥Grade 3) to any study therapies including any excipients\n * Has an active autoimmune disease that has required systemic treatment in past 2 years\n * Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis\n * Has an active infection requiring systemic therapy\n * Has a known history of human immunodeficiency virus (HIV) infection\n * Has a known history of Hepatitis B or known active Hepatitis C virus infection\n * Has a known history of active tuberculosis\n * Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator\n * Has known psychiatric or substance abuse disorders that would interfere with cooperating with the requirements of the study\n * Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days (or longer, if required by the drug label of chemotherapy received by the participant on study) after the last dose of trial treatment",{"$nulls":4},"Actual","2018-01-23","Actual","Anticipated","2027-02-13","Anticipated","2019-12-01","2018-01-17","2018-01-17","2019-12-05","No","Programmed Death-1 (PD-1)\nPD1\nProgrammed Death-Ligand 1 (PD-L1)\nPDL1","Interventional","Treatment","Parallel Assignment","None (Open Label)","Non-Randomized","3 Years","25 Years","All",null,"No","Yes\nhttp://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf",{"$nulls":3},"Yes","No",{"$nulls":17},"2017-001123-53|MK-3475-667","EudraCT Number|Merck Protocol Number","Objective Response Rate (ORR) in SER Participants By Risk Group (Low, High) as Assessed by Blinded Independent Central Review (BICR)","ORR is defined as the percentage of SER participants who have a Complete Response (","CR, disappearance of all evidence of disease) or Partial Response (","Rate of Positron Emission Tomography (PET) Scan Negativity in SER Participants By Risk Group (Low, High) After AVD or COPDAC-28 Chemotherapy|Event-Free Survival (EFS) in SER Participants By Risk Group (Low, High) as Assessed by BICR|Overall Survival (OS) in SER Participants By Risk Group (Low, High)|Exposure to Radiotherapy (RT) in SER Participants By Risk Group (Low, High)|Rate of PET Scan Negativity In Group 1 Participants After ABVD Induction Therapy|EFS in Rapid Early Responder (RER) Participants By Risk Group (Low, High) as Assessed by Investigator|OS in RER Participants By Risk Group (Low, High)|Serum Thymus and Activation-Regulated Chemokine (TARC) Levels in SER Participants By Risk Group (Low, High)|Number of SER Participants Experiencing an Adverse Event (AE) By Risk Group (Low, High)|Number of SER Participants Discontinuing Study Treatment Due to AEs By Risk Group (Low, High)","The rate of PET negativity for SER participants is the percentage of participants with PET negativity (defined as Deauville score 1, 2 or 3) after two cycles of AVD (Group 1) or four cycles of COPDAC-28 (Group 2), in combination with pembrolizumab. The Deauville 5-point scoring system is an internationally accepted and utilized five-point scoring system for the Fluorodeoxyglucose (FDG) avidity of a Hodgkin's lymphoma or Non-Hodgkin's lymphoma tumor mass as seen on FDG PET scan: Score 1= No uptake above the background, Score 2= Uptake â‰¤ mediastinum, Score 3= Uptake > mediastinum but â‰¤ liver, Score 4= Uptake moderately increased compared to the liver at any site, Score 5= Uptake markedly increased compared to the liver at any site or new lesions, Score X= New areas of uptake unlikely to be related to lymphoma. In the present study, scores of 1, 2 and 3 are considered to be negative and scores of 4 and 5 are considered to be positive.|EFS is defined as the time from study enrollment to the first documented disease progression or recurrence, or death due to any cause, whichever occurs first. Progression/disease recurrence will be determined by BICR using IWG criteria.|OS is defined as the time from study enrollment to death due to any cause. Participants without documented death will be censored at the date of the last follow-up.|The frequency of RT received by eligible participants (positive PET response, i.e. Deauville score of 4 or 5) will be reported.|The rate of PET negativity for Group 1 participants is the percentage of participants with PET negativity (defined as Deauville score 1, 2 or 3) after two cycles of ABVD induction. The Deauville 5-point scoring system is an internationally accepted and utilized five-point scoring system for the FDG avidity of a Hodgkin's lymphoma or Non-Hodgkin's lymphoma tumor mass as seen on FDG PET scan: Score 1= No uptake above the background, Score 2= Uptake â‰¤ mediastinum, Score 3= Uptake > mediastinum but â‰¤ liver, Score 4= Uptake moderately increased compared to the liver at any site, Score 5= Uptake markedly increased compared to the liver at any site or new lesions, Score X= New areas of uptake unlikely to be related to lymphoma. In the present study, scores of 1, 2 and 3 are considered to be negative and scores of 4 and 5 are considered to be positive.|EFS is defined as the time from study enrollment to the first documented disease progression or recurrence, or death due to any cause, whichever occurs first. Progression/disease recurrence will be determined by the investigator.|Serum TARC levels will be measured and evaluated as a potential biomarker in SER participants by risk group at screening, early, and late response assessments.|An AE is any untoward medical occurrence in a participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. The number of SER participants who experience an AE will be reported for each arm.|An AE is any untoward medical occurrence in a participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. The number of SER participants who discontinue study treatment due to an AE will be reported for each arm.","Up to 5 years","Trialsites@merck.com","Toll Free Number","1-888-577-8839","Praha 5, Czechia, 150 06|Barcelona, Spain, 08035|Little Rock, Arkansas, United States, 72202|New Haven, Connecticut, United States, 06510|Hollywood, Florida, United States, 33021|Detroit, Michigan, United States, 48201|Las Vegas, Nevada, United States, 89135|New Brunswick, New Jersey, United States, 08901|Cincinnati, Ohio, United States, 45229|Greenville, South Carolina, United States, 29607","Arkansas|Connecticut|Florida|Michigan|Nevada|New Jersey|Ohio|South Carolina","Czechia|Spain|United States","Fakultni Nemocnice V Motole ( Site 0356)|Hospital Universitari Vall D Hebron ( Site 0432)|Arkansas Children's Hospital ( Site 0046)|Yale Cancer Center ( Site 0061)|Memorial Regional Hospital/Joe Dimaggio Children's Hospital ( Site 0048)|Karmanos Cancer Institute ( Site 0002)|Alliance For Childhood Diseases ( Site 0064)|Rutgers Cancer Institute Of New Jersey ( Site 0027)|Cincinnati Children's Hospital Medical Center ( Site 0035)|St. Francis Hospital Cancer Center ( Site 0001)",{"$nulls":3},"Medical Director","2019-12-05","2020-05-25T16:38:08.248","2020-05-26T17:10:42.972","NCT03407144"]
["5ecbf47011702c1b1b916b18","NCT03407144","2020-01-06","Merck","MRK","Recruiting","Safety and Efficacy of Pembrolizumab (MK-3475) in Children and Young Adults With Classical Hodgkin Lymphoma (MK-3475-667/KEYNOTE-667)","Pembrolizumab|Doxorubicin|Vinblastine|Dacarbazine|Bleomycin|Cyclophosphamide|Vincristine|Prednisolone|Prednisone|Etoposide","PD-1 Inhibitor|TOP2 Inhibitor|Tubulin Inhibitor|Mitosis Inhibitor|P-gp Modulator|DNA Mtase Inhibitor|DNA Synthesis Inhibitor|Immunomodulator|Mitosis Inhibitor|Tubulin Inhibitor|GR Agonist|GR Agonist|Immunosuppressive","Yes","['Bleomycin']","Unknown",null,"Phase 2",2,440,"Anticipated","2018-04-09","2027-02-13","RR","Response Rate",{"$nulls":3},"This study will examine the safety and efficacy of pembrolizumab (MK-3475) in combination with chemotherapy in children and young adults with newly diagnosed classical Hodgkin Lymphoma (cHL) who are slow early responders (SERs) to frontline chemotherapy.","Group 1 will consist of low-risk participants with cHL Stages IA, IB and IIA without bulky disease. Group 2 will consist of high-risk participants with cHL Stages IIEB, IIIEA, IIIEB, IIIB, IVA and IVB.","An Open-label, Uncontrolled, Multicenter Phase II Trial of MK-3475 (Pembrolizumab) in Children and Young Adults With Newly Diagnosed Classical Hodgkin Lymphoma With Inadequate (Slow Early) Response to Frontline Chemotherapy (KEYNOTE 667)","3475-667","Hodgkin Lymphoma","Lymphoma","Oncology Hematological","Oncology","Experimental","Pembrolizumab + AVD (Group 1)|Pembrolizumab + COPDAC-28 (Group 2)","After receiving two 4-week cycles of ABVD (doxorubicin, bleomycin, vinblastine and dacarbazine) induction therapy, SER participants in Group 1 will receive pembrolizumab 2 mg/kg up to a maximum of 200 mg (3 to 17 years of age) or 200 mg (18 to 25 years of age) on Day 1 of each 3-week cycle (Q3W) in combination with two cycles of AVD chemotherapy (doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2 and dacarbazine 375 mg/m^2 on Days 1 and 15; cycle frequency every 4 weeks [Q4W]). All SERs in Group 1 will receive radiotherapy (RT) after completing AVD chemotherapy.|After receiving two 4-week cycles of OEPA (vincristine, etoposide/etopophos, prednisone/prednisolone and doxorubicin) induction therapy, SER participants in Group 2 will receive pembrolizumab 2 mg/kg up to a maximum of 200 mg (3 to 17 years of age) or 200 mg (18 to 25 years of age) Q3W, in combination with 4 cycles of COPDAC-28 chemotherapy (cyclophosphamide 500 mg/m^2 on Days 1 and 8, vincristine 1.5 mg/m^2 with maximum single dose 2 mg on Days 1 and 8, prednisone/prednisolone 40 mg/m^2/day divided in 3 doses on Days 1 to 15, dacarbazine 250 mg/m^2 on Days 1 to 3; cycle frequency Q4W). SERs in Group 2 will receive RT if they have a positive Positron Emission Tomography (PET) response after completing COPDAC-28 chemotherapy.","Biological|Drug","pembrolizumab|doxorubicin|vinblastine|dacarbazine|bleomycin|Radiation: Radiotherapy (RT)|cyclophosphamide|vincristine|prednisone/prednisolone|etoposide","2 mg/kg intravenous (IV) up to a max of 200 mg (3 to 17 years of age) or 200 mg IV (18 to 25 years of age); cycle frequency Q3W|10 units/m^2 IV on Days 1 and 15 as part of ABVD induction therapy (cycle frequency: Q4W, Group 1)|RT administered daily, dose dependent on randomization group and disease response.|500 mg/m^2 IV on days 1 and 8 as part of COPDAC-28 chemotherapy (cycle frequency: Q4W, Group 2)|125 mg/m^2 IV on Days 1 to 5 as part of OEPA induction therapy (cycle frequency: Q4W, Group 2)","MK-3475|Etoposide Phosphate","Pembrolizumab + AVD (Group 1)|Pembrolizumab + COPDAC-28 (Group 2)","\n\n * Group 1: Must have newly diagnosed, pathologically confirmed cHL at Stages IA, IB and IIA without bulky disease. Group 2: Must have newly diagnosed, pathologically confirmed cHL at Stages IIEB, IIIEA,IIIEB, IIIB, IVA and IVB\n * Has measurable disease per investigator assessment\n * Male participants must agree to use approved contraception during the treatment period and for at least 120 days (or longer, if required by the drug label of chemotherapy received by the participant on study) after the last dose of study treatment and refrain from donating sperm during this period\n * Female participants who are not pregnant or breastfeeding, and who are either not a woman of childbearing potential (WOCBP), or are a WOCBP who agrees to use approved contraception during the treatment period and for at least 120 days (or longer, if required by the drug label of chemotherapy received by the participant on study) after the last dose of study treatment\n * Performance status: Lansky Play-Performance Scale â‰¥50 for children up to and including 16 years of age OR Karnofsky score â‰¥50 for participants >16 years of age\n * Has adequate organ function\n\n","\n\n * Has undergone solid organ transplant at any time, or prior allogeneic hematopoietic stem cell transplantation within the last 5 years\n * WOCBP who has a positive urine pregnancy test within 72 hours before the first dose of study treatment\n * Baseline left ventricular ejection fraction value <50% or shortening fraction of <27%\n * Has received prior therapy with an anti-Programmed Death (PD)-1, anti-Programmed Death-Ligand 1 (PD-L1), or anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor or has previously participated in a Merck pembrolizumab (MK-3475) clinical study\n * Has received any prior anti-cancer therapy, monoclonal antibody, chemotherapy, or an investigational agent or device before the first dose of study treatment, or has not recovered from AEs due to previously administered agents\n * Has received a live vaccine within 30 days prior to the first dose of pembrolizumab\n * Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment\n * Has a diagnosis of lymphocyte-predominant Hodgkin Lymphoma (HL)\n * Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of pembrolizumab\n * Has a known additional malignancy that is progressing or requires active treatment\n * Has radiographically detectable central nervous system metastases and/or carcinomatous meningitis as assessed by local site investigator at the time of diagnosis\n * Has severe hypersensitivity (â‰¥Grade 3) to any study therapies including any excipients\n * Has an active autoimmune disease that has required systemic treatment in past 2 years\n * Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis\n * Has an active infection requiring systemic therapy\n * Has a known history of human immunodeficiency virus (HIV) infection\n * Has a known history of Hepatitis B or known active Hepatitis C virus infection\n * Has a known history of active tuberculosis\n * Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator\n * Has known psychiatric or substance abuse disorders that would interfere with cooperating with the requirements of the study\n * Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days (or longer, if required by the drug label of chemotherapy received by the participant on study) after the last dose of trial treatment",{"$nulls":4},"Actual","2018-01-23","Actual","Anticipated","2027-02-13","Anticipated","2020-01-01","2018-01-17","2018-01-17","2020-01-03","No","Programmed Death-1 (PD-1)\nPD1\nProgrammed Death-Ligand 1 (PD-L1)\nPDL1","Interventional","Treatment","Parallel Assignment","None (Open Label)","Non-Randomized","3 Years","25 Years","All",null,"No","Yes\nhttp://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf",{"$nulls":3},"Yes","No",{"$nulls":17},"2017-001123-53|MK-3475-667","EudraCT Number|Merck Protocol Number","Objective Response Rate (ORR) in SER Participants By Risk Group (Low, High) as Assessed by Blinded Independent Central Review (BICR)","ORR is defined as the percentage of SER participants who have a Complete Response (","CR, disappearance of all evidence of disease) or Partial Response (","Rate of Positron Emission Tomography (PET) Scan Negativity in SER Participants By Risk Group (Low, High) After AVD or COPDAC-28 Chemotherapy|Event-Free Survival (EFS) in SER Participants By Risk Group (Low, High) as Assessed by BICR|Overall Survival (OS) in SER Participants By Risk Group (Low, High)|Exposure to Radiotherapy (RT) in SER Participants By Risk Group (Low, High)|Rate of PET Scan Negativity In Group 1 Participants After ABVD Induction Therapy|EFS in Rapid Early Responder (RER) Participants By Risk Group (Low, High) as Assessed by Investigator|OS in RER Participants By Risk Group (Low, High)|Serum Thymus and Activation-Regulated Chemokine (TARC) Levels in SER Participants By Risk Group (Low, High)|Number of SER Participants Experiencing an Adverse Event (AE) By Risk Group (Low, High)|Number of SER Participants Discontinuing Study Treatment Due to AEs By Risk Group (Low, High)","The rate of PET negativity for SER participants is the percentage of participants with PET negativity (defined as Deauville score 1, 2 or 3) after two cycles of AVD (Group 1) or four cycles of COPDAC-28 (Group 2), in combination with pembrolizumab. The Deauville 5-point scoring system is an internationally accepted and utilized five-point scoring system for the Fluorodeoxyglucose (FDG) avidity of a Hodgkin's lymphoma or Non-Hodgkin's lymphoma tumor mass as seen on FDG PET scan: Score 1= No uptake above the background, Score 2= Uptake â‰¤ mediastinum, Score 3= Uptake > mediastinum but â‰¤ liver, Score 4= Uptake moderately increased compared to the liver at any site, Score 5= Uptake markedly increased compared to the liver at any site or new lesions, Score X= New areas of uptake unlikely to be related to lymphoma. In the present study, scores of 1, 2 and 3 are considered to be negative and scores of 4 and 5 are considered to be positive.|EFS is defined as the time from study enrollment to the first documented disease progression or recurrence, or death due to any cause, whichever occurs first. Progression/disease recurrence will be determined by BICR using IWG criteria.|OS is defined as the time from study enrollment to death due to any cause. Participants without documented death will be censored at the date of the last follow-up.|The frequency of RT received by eligible participants (positive PET response, i.e. Deauville score of 4 or 5) will be reported.|The rate of PET negativity for Group 1 participants is the percentage of participants with PET negativity (defined as Deauville score 1, 2 or 3) after two cycles of ABVD induction. The Deauville 5-point scoring system is an internationally accepted and utilized five-point scoring system for the FDG avidity of a Hodgkin's lymphoma or Non-Hodgkin's lymphoma tumor mass as seen on FDG PET scan: Score 1= No uptake above the background, Score 2= Uptake â‰¤ mediastinum, Score 3= Uptake > mediastinum but â‰¤ liver, Score 4= Uptake moderately increased compared to the liver at any site, Score 5= Uptake markedly increased compared to the liver at any site or new lesions, Score X= New areas of uptake unlikely to be related to lymphoma. In the present study, scores of 1, 2 and 3 are considered to be negative and scores of 4 and 5 are considered to be positive.|EFS is defined as the time from study enrollment to the first documented disease progression or recurrence, or death due to any cause, whichever occurs first. Progression/disease recurrence will be determined by the investigator.|Serum TARC levels will be measured and evaluated as a potential biomarker in SER participants by risk group at screening, early, and late response assessments.|An AE is any untoward medical occurrence in a participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. The number of SER participants who experience an AE will be reported for each arm.|An AE is any untoward medical occurrence in a participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. The number of SER participants who discontinue study treatment due to an AE will be reported for each arm.","Up to 5 years","Trialsites@merck.com","Toll Free Number","1-888-577-8839","Praha 5, Czechia, 150 06|Aviano, Italy, 33081|Barcelona, Spain, 08035|Little Rock, Arkansas, United States, 72202|Los Angeles, California, United States, 90027|New Haven, Connecticut, United States, 06510|Hollywood, Florida, United States, 33021|Baltimore, Maryland, United States, 21287|Detroit, Michigan, United States, 48201|Las Vegas, Nevada, United States, 89135|New Brunswick, New Jersey, United States, 08901|Cincinnati, Ohio, United States, 45229|Greenville, South Carolina, United States, 29607|Austin, Texas, United States, 78723|Falls Church, Virginia, United States, 22042","Arkansas|California|Connecticut|Florida|Maryland|Michigan|Nevada|New Jersey|Ohio|South Carolina|Texas|Virginia","Czechia|Italy|Spain|United States","Fakultni Nemocnice V Motole ( Site 0356)|Centro Di Riferimento Oncologico Cro ( Site 0404)|Hospital Universitari Vall D Hebron ( Site 0432)|Arkansas Children's Hospital ( Site 0046)|Kaiser Permanente Downey Medical Center ( Site 0024)|Yale Cancer Center ( Site 0061)|Memorial Regional Hospital/Joe Dimaggio Children's Hospital ( Site 0048)|Johns Hopkins University ( Site 0025)|Karmanos Cancer Institute ( Site 0002)|Alliance For Childhood Diseases ( Site 0064)|Rutgers Cancer Institute Of New Jersey ( Site 0027)|Cincinnati Children's Hospital Medical Center ( Site 0035)|St. Francis Hospital Cancer Center ( Site 0001)|Dell Children's Medical Center Of Central Texas ( Site 0058)|Inova Fairfax Hospital ( Site 0031)",{"$nulls":3},"Medical Director","2020-01-03","2020-05-25T16:38:08.570","2020-05-26T17:10:42.972","NCT03407144"]
["5ecbf470e2561b1b11905e04","NCT03407144","2020-01-31","Merck","MRK","Recruiting","Safety and Efficacy of Pembrolizumab (MK-3475) in Children and Young Adults With Classical Hodgkin Lymphoma (MK-3475-667/KEYNOTE-667)","Pembrolizumab|Doxorubicin|Vinblastine|Dacarbazine|Bleomycin|Cyclophosphamide|Vincristine|Prednisolone|Prednisone|Etoposide","PD-1 Inhibitor|TOP2 Inhibitor|Tubulin Inhibitor|Mitosis Inhibitor|P-gp Modulator|DNA Mtase Inhibitor|DNA Synthesis Inhibitor|Immunomodulator|Mitosis Inhibitor|Tubulin Inhibitor|GR Agonist|GR Agonist|Immunosuppressive","Yes","['Bleomycin']","Unknown",null,"Phase 2",2,440,"Anticipated","2018-04-09","2027-02-13","RR","Response Rate",{"$nulls":3},"This study will examine the safety and efficacy of pembrolizumab (MK-3475) in combination with chemotherapy in children and young adults with newly diagnosed classical Hodgkin Lymphoma (cHL) who are slow early responders (SERs) to frontline chemotherapy.","Group 1 will consist of low-risk participants with cHL Stages IA, IB and IIA without bulky disease. Group 2 will consist of high-risk participants with cHL Stages IIEB, IIIEA, IIIEB, IIIB, IVA and IVB.","An Open-label, Uncontrolled, Multicenter Phase II Trial of MK-3475 (Pembrolizumab) in Children and Young Adults With Newly Diagnosed Classical Hodgkin Lymphoma With Inadequate (Slow Early) Response to Frontline Chemotherapy (KEYNOTE 667)","3475-667","Hodgkin Lymphoma","Lymphoma","Oncology Hematological","Oncology","Experimental","Pembrolizumab + AVD (Group 1)|Pembrolizumab + COPDAC-28 (Group 2)","After receiving two 4-week cycles of ABVD (doxorubicin, bleomycin, vinblastine and dacarbazine) induction therapy, SER participants in Group 1 will receive pembrolizumab 2 mg/kg up to a maximum of 200 mg (3 to 17 years of age) or 200 mg (18 to 25 years of age) on Day 1 of each 3-week cycle (Q3W) in combination with two cycles of AVD chemotherapy (doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2 and dacarbazine 375 mg/m^2 on Days 1 and 15; cycle frequency every 4 weeks [Q4W]). All SERs in Group 1 will receive radiotherapy (RT) after completing AVD chemotherapy.|After receiving two 4-week cycles of OEPA (vincristine, etoposide/etopophos, prednisone/prednisolone and doxorubicin) induction therapy, SER participants in Group 2 will receive pembrolizumab 2 mg/kg up to a maximum of 200 mg (3 to 17 years of age) or 200 mg (18 to 25 years of age) Q3W, in combination with 4 cycles of COPDAC-28 chemotherapy (cyclophosphamide 500 mg/m^2 on Days 1 and 8, vincristine 1.5 mg/m^2 with maximum single dose 2 mg on Days 1 and 8, prednisone/prednisolone 40 mg/m^2/day divided in 3 doses on Days 1 to 15, dacarbazine 250 mg/m^2 on Days 1 to 3; cycle frequency Q4W). SERs in Group 2 will receive RT if they have a positive Positron Emission Tomography (PET) response after completing COPDAC-28 chemotherapy.","Biological|Drug","pembrolizumab|doxorubicin|vinblastine|dacarbazine|bleomycin|Radiation: Radiotherapy (RT)|cyclophosphamide|vincristine|prednisone/prednisolone|etoposide","2 mg/kg intravenous (IV) up to a max of 200 mg (3 to 17 years of age) or 200 mg IV (18 to 25 years of age); cycle frequency Q3W|10 units/m^2 IV on Days 1 and 15 as part of ABVD induction therapy (cycle frequency: Q4W, Group 1)|RT administered daily, dose dependent on randomization group and disease response.|500 mg/m^2 IV on days 1 and 8 as part of COPDAC-28 chemotherapy (cycle frequency: Q4W, Group 2)|125 mg/m^2 IV on Days 1 to 5 as part of OEPA induction therapy (cycle frequency: Q4W, Group 2)","MK-3475|Etoposide Phosphate","Pembrolizumab + AVD (Group 1)|Pembrolizumab + COPDAC-28 (Group 2)","\n\n * Group 1: Must have newly diagnosed, pathologically confirmed cHL at Stages IA, IB and IIA without bulky disease. Group 2: Must have newly diagnosed, pathologically confirmed cHL at Stages IIEB, IIIEA,IIIEB, IIIB, IVA and IVB\n * Has measurable disease per investigator assessment\n * Male participants must agree to use approved contraception during the treatment period and for at least 120 days (or longer, if required by the drug label of chemotherapy received by the participant on study) after the last dose of study treatment and refrain from donating sperm during this period\n * Female participants who are not pregnant or breastfeeding, and who are either not a woman of childbearing potential (WOCBP), or are a WOCBP who agrees to use approved contraception during the treatment period and for at least 120 days (or longer, if required by the drug label of chemotherapy received by the participant on study) after the last dose of study treatment\n * Performance status: Lansky Play-Performance Scale â‰¥50 for children up to and including 16 years of age OR Karnofsky score â‰¥50 for participants >16 years of age\n * Has adequate organ function\n\n","\n\n * Has undergone solid organ transplant at any time, or prior allogeneic hematopoietic stem cell transplantation within the last 5 years\n * WOCBP who has a positive urine pregnancy test within 72 hours before the first dose of study treatment\n * Baseline left ventricular ejection fraction value <50% or shortening fraction of <27%\n * Has received prior therapy with an anti-Programmed Death (PD)-1, anti-Programmed Death-Ligand 1 (PD-L1), or anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor or has previously participated in a Merck pembrolizumab (MK-3475) clinical study\n * Has received any prior anti-cancer therapy, monoclonal antibody, chemotherapy, or an investigational agent or device before the first dose of study treatment, or has not recovered from AEs due to previously administered agents\n * Has received a live vaccine within 30 days prior to the first dose of pembrolizumab\n * Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment\n * Has a diagnosis of lymphocyte-predominant Hodgkin Lymphoma (HL)\n * Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of pembrolizumab\n * Has a known additional malignancy that is progressing or requires active treatment\n * Has radiographically detectable central nervous system metastases and/or carcinomatous meningitis as assessed by local site investigator at the time of diagnosis\n * Has severe hypersensitivity (â‰¥Grade 3) to any study therapies including any excipients\n * Has an active autoimmune disease that has required systemic treatment in past 2 years\n * Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis\n * Has an active infection requiring systemic therapy\n * Has a known history of human immunodeficiency virus (HIV) infection\n * Has a known history of Hepatitis B or known active Hepatitis C virus infection\n * Has a known history of active tuberculosis\n * Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator\n * Has known psychiatric or substance abuse disorders that would interfere with cooperating with the requirements of the study\n * Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days (or longer, if required by the drug label of chemotherapy received by the participant on study) after the last dose of trial treatment",{"$nulls":4},"Actual","2018-01-23","Actual","Anticipated","2027-02-13","Anticipated","2020-01-01","2018-01-17","2018-01-17","2020-01-30","No","Programmed Death-1 (PD-1)\nPD1\nProgrammed Death-Ligand 1 (PD-L1)\nPDL1","Interventional","Treatment","Parallel Assignment","None (Open Label)","Non-Randomized","3 Years","25 Years","All",null,"No","Yes\nhttp://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf",{"$nulls":3},"Yes","No",{"$nulls":17},"2017-001123-53|MK-3475-667","EudraCT Number|Merck Protocol Number","Objective Response Rate (ORR) in SER Participants By Risk Group (Low, High) as Assessed by Blinded Independent Central Review (BICR)","ORR is defined as the percentage of SER participants who have a Complete Response (","CR, disappearance of all evidence of disease) or Partial Response (","Rate of Positron Emission Tomography (PET) Scan Negativity in SER Participants By Risk Group (Low, High) After AVD or COPDAC-28 Chemotherapy|Event-Free Survival (EFS) in SER Participants By Risk Group (Low, High) as Assessed by BICR|Overall Survival (OS) in SER Participants By Risk Group (Low, High)|Exposure to Radiotherapy (RT) in SER Participants By Risk Group (Low, High)|Rate of PET Scan Negativity In Group 1 Participants After ABVD Induction Therapy|EFS in Rapid Early Responder (RER) Participants By Risk Group (Low, High) as Assessed by Investigator|OS in RER Participants By Risk Group (Low, High)|Serum Thymus and Activation-Regulated Chemokine (TARC) Levels in SER Participants By Risk Group (Low, High)|Number of SER Participants Experiencing an Adverse Event (AE) By Risk Group (Low, High)|Number of SER Participants Discontinuing Study Treatment Due to AEs By Risk Group (Low, High)","The rate of PET negativity for SER participants is the percentage of participants with PET negativity (defined as Deauville score 1, 2 or 3) after two cycles of AVD (Group 1) or four cycles of COPDAC-28 (Group 2), in combination with pembrolizumab. The Deauville 5-point scoring system is an internationally accepted and utilized five-point scoring system for the Fluorodeoxyglucose (FDG) avidity of a Hodgkin's lymphoma or Non-Hodgkin's lymphoma tumor mass as seen on FDG PET scan: Score 1= No uptake above the background, Score 2= Uptake â‰¤ mediastinum, Score 3= Uptake > mediastinum but â‰¤ liver, Score 4= Uptake moderately increased compared to the liver at any site, Score 5= Uptake markedly increased compared to the liver at any site or new lesions, Score X= New areas of uptake unlikely to be related to lymphoma. In the present study, scores of 1, 2 and 3 are considered to be negative and scores of 4 and 5 are considered to be positive.|EFS is defined as the time from study enrollment to the first documented disease progression or recurrence, or death due to any cause, whichever occurs first. Progression/disease recurrence will be determined by BICR using IWG criteria.|OS is defined as the time from study enrollment to death due to any cause. Participants without documented death will be censored at the date of the last follow-up.|The frequency of RT received by eligible participants (positive PET response, i.e. Deauville score of 4 or 5) will be reported.|The rate of PET negativity for Group 1 participants is the percentage of participants with PET negativity (defined as Deauville score 1, 2 or 3) after two cycles of ABVD induction. The Deauville 5-point scoring system is an internationally accepted and utilized five-point scoring system for the FDG avidity of a Hodgkin's lymphoma or Non-Hodgkin's lymphoma tumor mass as seen on FDG PET scan: Score 1= No uptake above the background, Score 2= Uptake â‰¤ mediastinum, Score 3= Uptake > mediastinum but â‰¤ liver, Score 4= Uptake moderately increased compared to the liver at any site, Score 5= Uptake markedly increased compared to the liver at any site or new lesions, Score X= New areas of uptake unlikely to be related to lymphoma. In the present study, scores of 1, 2 and 3 are considered to be negative and scores of 4 and 5 are considered to be positive.|EFS is defined as the time from study enrollment to the first documented disease progression or recurrence, or death due to any cause, whichever occurs first. Progression/disease recurrence will be determined by the investigator.|Serum TARC levels will be measured and evaluated as a potential biomarker in SER participants by risk group at screening, early, and late response assessments.|An AE is any untoward medical occurrence in a participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. The number of SER participants who experience an AE will be reported for each arm.|An AE is any untoward medical occurrence in a participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. The number of SER participants who discontinue study treatment due to an AE will be reported for each arm.","Up to 5 years","Trialsites@merck.com","Toll Free Number","1-888-577-8839","Praha 5, Czechia, 150 06|Aviano, Italy, 33081|Barcelona, Spain, 08035|Little Rock, Arkansas, United States, 72202|Downey, California, United States, 90242|New Haven, Connecticut, United States, 06510|Hollywood, Florida, United States, 33021|Baltimore, Maryland, United States, 21287|Detroit, Michigan, United States, 48201|Minneapolis, Minnesota, United States, 55404|Las Vegas, Nevada, United States, 89135|New Brunswick, New Jersey, United States, 08901|Cincinnati, Ohio, United States, 45229|Greenville, South Carolina, United States, 29607|Austin, Texas, United States, 78723|Falls Church, Virginia, United States, 22042","Arkansas|California|Connecticut|Florida|Maryland|Michigan|Minnesota|Nevada|New Jersey|Ohio|South Carolina|Texas|Virginia","Czechia|Italy|Spain|United States","Fakultni Nemocnice V Motole ( Site 0356)|Centro Di Riferimento Oncologico Cro ( Site 0404)|Hospital Universitari Vall D Hebron ( Site 0432)|Arkansas Children's Hospital ( Site 0046)|Kaiser Permanente ( Site 0082)|Yale Cancer Center ( Site 0061)|Memorial Regional Hospital/Joe Dimaggio Children's Hospital ( Site 0048)|Johns Hopkins University ( Site 0025)|Karmanos Cancer Institute ( Site 0002)|Children's Hospitals And Clinics Of Minnesota ( Site 0036)|Alliance For Childhood Diseases ( Site 0064)|Rutgers Cancer Institute Of New Jersey ( Site 0027)|Cincinnati Children's Hospital Medical Center ( Site 0035)|St. Francis Hospital Cancer Center ( Site 0001)|Dell Children's Medical Center Of Central Texas ( Site 0058)|Inova Fairfax Hospital ( Site 0031)",{"$nulls":3},"Medical Director","2020-01-30","2020-05-25T16:38:08.528","2020-05-26T17:10:42.972","NCT03407144"]
["5ecbf471fe30261b1a04830b","NCT03407144","2020-02-27","Merck","MRK","Recruiting","Safety and Efficacy of Pembrolizumab (MK-3475) in Children and Young Adults With Classical Hodgkin Lymphoma (MK-3475-667/KEYNOTE-667)","Pembrolizumab|Doxorubicin|Vinblastine|Dacarbazine|Bleomycin|Cyclophosphamide|Vincristine|Prednisolone|Prednisone|Etoposide","PD-1 Inhibitor|TOP2 Inhibitor|Tubulin Inhibitor|Mitosis Inhibitor|P-gp Modulator|DNA Mtase Inhibitor|DNA Synthesis Inhibitor|Immunomodulator|Mitosis Inhibitor|Tubulin Inhibitor|GR Agonist|GR Agonist|Immunosuppressive","Yes","['Bleomycin']","Unknown",null,"Phase 2",2,440,"Anticipated","2018-04-09","2027-02-13","RR","Response Rate",{"$nulls":3},"This study will examine the safety and efficacy of pembrolizumab (MK-3475) in combination with chemotherapy in children and young adults with newly diagnosed classical Hodgkin Lymphoma (cHL) who are slow early responders (SERs) to frontline chemotherapy.","Group 1 will consist of low-risk participants with cHL Stages IA, IB and IIA without bulky disease. Group 2 will consist of high-risk participants with cHL Stages IIEB, IIIEA, IIIEB, IIIB, IVA and IVB.","An Open-label, Uncontrolled, Multicenter Phase II Trial of MK-3475 (Pembrolizumab) in Children and Young Adults With Newly Diagnosed Classical Hodgkin Lymphoma With Inadequate (Slow Early) Response to Frontline Chemotherapy (KEYNOTE 667)","3475-667","Hodgkin Lymphoma","Lymphoma","Oncology Hematological","Oncology","Experimental","Pembrolizumab + AVD (Group 1)|Pembrolizumab + COPDAC-28 (Group 2)","After receiving two 4-week cycles of ABVD (doxorubicin, bleomycin, vinblastine and dacarbazine) induction therapy, SER participants in Group 1 will receive pembrolizumab 2 mg/kg up to a maximum of 200 mg (3 to 17 years of age) or 200 mg (18 to 25 years of age) on Day 1 of each 3-week cycle (Q3W) in combination with two cycles of AVD chemotherapy (doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2 and dacarbazine 375 mg/m^2 on Days 1 and 15; cycle frequency every 4 weeks [Q4W]). All SERs in Group 1 will receive radiotherapy (RT) after completing AVD chemotherapy.|After receiving two 4-week cycles of OEPA (vincristine, etoposide/etopophos, prednisone/prednisolone and doxorubicin) induction therapy, SER participants in Group 2 will receive pembrolizumab 2 mg/kg up to a maximum of 200 mg (3 to 17 years of age) or 200 mg (18 to 25 years of age) Q3W, in combination with 4 cycles of COPDAC-28 chemotherapy (cyclophosphamide 500 mg/m^2 on Days 1 and 8, vincristine 1.5 mg/m^2 with maximum single dose 2 mg on Days 1 and 8, prednisone/prednisolone 40 mg/m^2/day divided in 3 doses on Days 1 to 15, dacarbazine 250 mg/m^2 on Days 1 to 3; cycle frequency Q4W). SERs in Group 2 will receive RT if they have a positive Positron Emission Tomography (PET) response after completing COPDAC-28 chemotherapy.","Biological|Drug","pembrolizumab|doxorubicin|vinblastine|dacarbazine|bleomycin|Radiation: Radiotherapy (RT)|cyclophosphamide|vincristine|prednisone/prednisolone|etoposide","2 mg/kg intravenous (IV) up to a max of 200 mg (3 to 17 years of age) or 200 mg IV (18 to 25 years of age); cycle frequency Q3W|10 units/m^2 IV on Days 1 and 15 as part of ABVD induction therapy (cycle frequency: Q4W, Group 1)|RT administered daily, dose dependent on randomization group and disease response.|500 mg/m^2 IV on days 1 and 8 as part of COPDAC-28 chemotherapy (cycle frequency: Q4W, Group 2)|125 mg/m^2 IV on Days 1 to 5 as part of OEPA induction therapy (cycle frequency: Q4W, Group 2)","MK-3475|Etoposide Phosphate","Pembrolizumab + AVD (Group 1)|Pembrolizumab + COPDAC-28 (Group 2)","\n\n * Group 1: Must have newly diagnosed, pathologically confirmed cHL at Stages IA, IB and IIA without bulky disease. Group 2: Must have newly diagnosed, pathologically confirmed cHL at Stages IIEB, IIIEA,IIIEB, IIIB, IVA and IVB\n * Has measurable disease per investigator assessment\n * Male participants must agree to use approved contraception during the treatment period and for at least 120 days (or longer, if required by the drug label of chemotherapy received by the participant on study) after the last dose of study treatment and refrain from donating sperm during this period\n * Female participants who are not pregnant or breastfeeding, and who are either not a woman of childbearing potential (WOCBP), or are a WOCBP who agrees to use approved contraception during the treatment period and for at least 120 days (or longer, if required by the drug label of chemotherapy received by the participant on study) after the last dose of study treatment\n * Performance status: Lansky Play-Performance Scale â‰¥50 for children up to and including 16 years of age OR Karnofsky score â‰¥50 for participants >16 years of age\n * Has adequate organ function\n\n","\n\n * Has undergone solid organ transplant at any time, or prior allogeneic hematopoietic stem cell transplantation within the last 5 years\n * WOCBP who has a positive urine pregnancy test within 72 hours before the first dose of study treatment\n * Baseline left ventricular ejection fraction value <50% or shortening fraction of <27%\n * Has received prior therapy with an anti-Programmed Death (PD)-1, anti-Programmed Death-Ligand 1 (PD-L1), or anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor or has previously participated in a Merck pembrolizumab (MK-3475) clinical study\n * Has received any prior anti-cancer therapy, monoclonal antibody, chemotherapy, or an investigational agent or device before the first dose of study treatment, or has not recovered from AEs due to previously administered agents\n * Has received a live vaccine within 30 days prior to the first dose of pembrolizumab\n * Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment\n * Has a diagnosis of lymphocyte-predominant Hodgkin Lymphoma (HL)\n * Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of pembrolizumab\n * Has a known additional malignancy that is progressing or requires active treatment\n * Has radiographically detectable central nervous system metastases and/or carcinomatous meningitis as assessed by local site investigator at the time of diagnosis\n * Has severe hypersensitivity (â‰¥Grade 3) to any study therapies including any excipients\n * Has an active autoimmune disease that has required systemic treatment in past 2 years\n * Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis\n * Has an active infection requiring systemic therapy\n * Has a known history of human immunodeficiency virus (HIV) infection\n * Has a known history of Hepatitis B or known active Hepatitis C virus infection\n * Has a known history of active tuberculosis\n * Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator\n * Has known psychiatric or substance abuse disorders that would interfere with cooperating with the requirements of the study\n * Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days (or longer, if required by the drug label of chemotherapy received by the participant on study) after the last dose of trial treatment",{"$nulls":4},"Actual","2018-01-23","Actual","Anticipated","2027-02-13","Anticipated","2020-02-01","2018-01-17","2018-01-17","2020-02-26","No","Programmed Death-1 (PD-1)\nPD1\nProgrammed Death-Ligand 1 (PD-L1)\nPDL1","Interventional","Treatment","Parallel Assignment","None (Open Label)","Non-Randomized","3 Years","25 Years","All",null,"No","Yes\nhttp://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf",null,"URL: http://merckoncologyclinicaltrials.com [http://merckoncologyclinicaltrials.com] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: Merck Oncology Clinical Trials Information",null,"Yes","No",{"$nulls":17},"2017-001123-53|MK-3475-667","EudraCT Number|Merck Protocol Number","Objective Response Rate (ORR) in SER Participants By Risk Group (Low, High) as Assessed by Blinded Independent Central Review (BICR)","ORR is defined as the percentage of SER participants who have a Complete Response (","CR, disappearance of all evidence of disease) or Partial Response (","Rate of Positron Emission Tomography (PET) Scan Negativity in SER Participants By Risk Group (Low, High) After AVD or COPDAC-28 Chemotherapy|Event-Free Survival (EFS) in SER Participants By Risk Group (Low, High) as Assessed by BICR|Overall Survival (OS) in SER Participants By Risk Group (Low, High)|Exposure to Radiotherapy (RT) in SER Participants By Risk Group (Low, High)|Rate of PET Scan Negativity In Group 1 Participants After ABVD Induction Therapy|EFS in Rapid Early Responder (RER) Participants By Risk Group (Low, High) as Assessed by Investigator|OS in RER Participants By Risk Group (Low, High)|Serum Thymus and Activation-Regulated Chemokine (TARC) Levels in SER Participants By Risk Group (Low, High)|Number of SER Participants Experiencing an Adverse Event (AE) By Risk Group (Low, High)|Number of SER Participants Discontinuing Study Treatment Due to AEs By Risk Group (Low, High)","The rate of PET negativity for SER participants is the percentage of participants with PET negativity (defined as Deauville score 1, 2 or 3) after two cycles of AVD (Group 1) or four cycles of COPDAC-28 (Group 2), in combination with pembrolizumab. The Deauville 5-point scoring system is an internationally accepted and utilized five-point scoring system for the Fluorodeoxyglucose (FDG) avidity of a Hodgkin's lymphoma or Non-Hodgkin's lymphoma tumor mass as seen on FDG PET scan: Score 1= No uptake above the background, Score 2= Uptake â‰¤ mediastinum, Score 3= Uptake > mediastinum but â‰¤ liver, Score 4= Uptake moderately increased compared to the liver at any site, Score 5= Uptake markedly increased compared to the liver at any site or new lesions, Score X= New areas of uptake unlikely to be related to lymphoma. In the present study, scores of 1, 2 and 3 are considered to be negative and scores of 4 and 5 are considered to be positive.|EFS is defined as the time from study enrollment to the first documented disease progression or recurrence, or death due to any cause, whichever occurs first. Progression/disease recurrence will be determined by BICR using IWG criteria.|OS is defined as the time from study enrollment to death due to any cause. Participants without documented death will be censored at the date of the last follow-up.|The frequency of RT received by eligible participants (positive PET response, i.e. Deauville score of 4 or 5) will be reported.|The rate of PET negativity for Group 1 participants is the percentage of participants with PET negativity (defined as Deauville score 1, 2 or 3) after two cycles of ABVD induction. The Deauville 5-point scoring system is an internationally accepted and utilized five-point scoring system for the FDG avidity of a Hodgkin's lymphoma or Non-Hodgkin's lymphoma tumor mass as seen on FDG PET scan: Score 1= No uptake above the background, Score 2= Uptake â‰¤ mediastinum, Score 3= Uptake > mediastinum but â‰¤ liver, Score 4= Uptake moderately increased compared to the liver at any site, Score 5= Uptake markedly increased compared to the liver at any site or new lesions, Score X= New areas of uptake unlikely to be related to lymphoma. In the present study, scores of 1, 2 and 3 are considered to be negative and scores of 4 and 5 are considered to be positive.|EFS is defined as the time from study enrollment to the first documented disease progression or recurrence, or death due to any cause, whichever occurs first. Progression/disease recurrence will be determined by the investigator.|Serum TARC levels will be measured and evaluated as a potential biomarker in SER participants by risk group at screening, early, and late response assessments.|An AE is any untoward medical occurrence in a participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. The number of SER participants who experience an AE will be reported for each arm.|An AE is any untoward medical occurrence in a participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. The number of SER participants who discontinue study treatment due to an AE will be reported for each arm.","Up to 5 years","Trialsites@merck.com","Toll Free Number","1-888-577-8839","Barranquilla, Colombia, 080020|Praha 5, Czechia, 150 06|Aviano, Italy, 33081|Barcelona, Spain, 08035|Little Rock, Arkansas, United States, 72202|Downey, California, United States, 90242|New Haven, Connecticut, United States, 06510|Hollywood, Florida, United States, 33021|Atlanta, Georgia, United States, 30322-1062|Baltimore, Maryland, United States, 21287|Detroit, Michigan, United States, 48201|Minneapolis, Minnesota, United States, 55404|Las Vegas, Nevada, United States, 89135|Hackensack, New Jersey, United States, 07601|Chapel Hill, North Carolina, United States, 27514|Cincinnati, Ohio, United States, 45229|Greenville, South Carolina, United States, 29607|Austin, Texas, United States, 78723|Falls Church, Virginia, United States, 22042","Arkansas|California|Connecticut|Florida|Georgia|Maryland|Michigan|Minnesota|Nevada|New Jersey|North Carolina|Ohio|South Carolina|Texas|Virginia","Colombia|Czechia|Italy|Spain|United States","Organizacion Clinica Bonnadona-Prevenir S.A.S. ( Site 0529)|Fakultni Nemocnice V Motole ( Site 0356)|Centro Di Riferimento Oncologico Cro ( Site 0404)|Hospital Universitari Vall D Hebron ( Site 0432)|Arkansas Children's Hospital ( Site 0046)|Kaiser Permanente ( Site 0082)|Yale Cancer Center ( Site 0061)|Memorial Regional Hospital/Joe Dimaggio Children's Hospital ( Site 0048)|Children's Healthcare Of Atlanta At Egleston ( Site 0033)|Johns Hopkins University ( Site 0025)|Karmanos Cancer Institute ( Site 0002)|Children's Hospitals And Clinics Of Minnesota ( Site 0036)|Alliance For Childhood Diseases ( Site 0064)|Hackensack University Medical Center ( Site 0026)|Unc Lineberger Comprehensive Cancer ( Site 0044)|Cincinnati Children's Hospital Medical Center ( Site 0035)|St. Francis Hospital Cancer Center ( Site 0001)|Dell Children's Medical Center Of Central Texas ( Site 0058)|Inova Fairfax Hospital ( Site 0031)",{"$nulls":3},"Medical Director","2020-02-26","2020-05-25T16:38:09.135","2020-05-26T17:10:42.972","NCT03407144"]
["5ecbf470feab101b15530939","NCT03407144","2020-03-13","Merck","MRK","Recruiting","Safety and Efficacy of Pembrolizumab (MK-3475) in Children and Young Adults With Classical Hodgkin Lymphoma (MK-3475-667/KEYNOTE-667)","Pembrolizumab|Doxorubicin|Vinblastine|Dacarbazine|Bleomycin|Cyclophosphamide|Vincristine|Prednisolone|Prednisone|Etoposide","PD-1 Inhibitor|TOP2 Inhibitor|Tubulin Inhibitor|Mitosis Inhibitor|P-gp Modulator|DNA Mtase Inhibitor|DNA Synthesis Inhibitor|Immunomodulator|Mitosis Inhibitor|Tubulin Inhibitor|GR Agonist|GR Agonist|Immunosuppressive","Yes","['Bleomycin']","Unknown",null,"Phase 2",2,440,"Anticipated","2018-04-09","2027-02-13","RR","Response Rate",{"$nulls":3},"This study will examine the safety and efficacy of pembrolizumab (MK-3475) in combination with chemotherapy in children and young adults with newly diagnosed classical Hodgkin Lymphoma (cHL) who are slow early responders (SERs) to frontline chemotherapy.","Group 1 will consist of low-risk participants with cHL Stages IA, IB and IIA without bulky disease. Group 2 will consist of high-risk participants with cHL Stages IIEB, IIIEA, IIIEB, IIIB, IVA and IVB.","An Open-label, Uncontrolled, Multicenter Phase II Trial of MK-3475 (Pembrolizumab) in Children and Young Adults With Newly Diagnosed Classical Hodgkin Lymphoma With Inadequate (Slow Early) Response to Frontline Chemotherapy (KEYNOTE 667)","3475-667","Hodgkin Lymphoma","Lymphoma","Oncology Hematological","Oncology","Experimental","Pembrolizumab + AVD (Group 1)|Pembrolizumab + COPDAC-28 (Group 2)","After receiving two 4-week cycles of ABVD (doxorubicin, bleomycin, vinblastine and dacarbazine) induction therapy, SER participants in Group 1 will receive pembrolizumab 2 mg/kg up to a maximum of 200 mg (3 to 17 years of age) or 200 mg (18 to 25 years of age) on Day 1 of each 3-week cycle (Q3W) in combination with two cycles of AVD chemotherapy (doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2 and dacarbazine 375 mg/m^2 on Days 1 and 15; cycle frequency every 4 weeks [Q4W]). All SERs in Group 1 will receive radiotherapy (RT) after completing AVD chemotherapy.|After receiving two 4-week cycles of OEPA (vincristine, etoposide/etopophos, prednisone/prednisolone and doxorubicin) induction therapy, SER participants in Group 2 will receive pembrolizumab 2 mg/kg up to a maximum of 200 mg (3 to 17 years of age) or 200 mg (18 to 25 years of age) Q3W, in combination with 4 cycles of COPDAC-28 chemotherapy (cyclophosphamide 500 mg/m^2 on Days 1 and 8, vincristine 1.5 mg/m^2 with maximum single dose 2 mg on Days 1 and 8, prednisone/prednisolone 40 mg/m^2/day divided in 3 doses on Days 1 to 15, dacarbazine 250 mg/m^2 on Days 1 to 3; cycle frequency Q4W). SERs in Group 2 will receive RT if they have a positive Positron Emission Tomography (PET) response after completing COPDAC-28 chemotherapy.","Biological|Drug","pembrolizumab|doxorubicin|vinblastine|dacarbazine|bleomycin|Radiation: Radiotherapy (RT)|cyclophosphamide|vincristine|prednisone/prednisolone|etoposide","2 mg/kg intravenous (IV) up to a max of 200 mg (3 to 17 years of age) or 200 mg IV (18 to 25 years of age); cycle frequency Q3W|10 units/m^2 IV on Days 1 and 15 as part of ABVD induction therapy (cycle frequency: Q4W, Group 1)|RT administered daily, dose dependent on randomization group and disease response.|500 mg/m^2 IV on days 1 and 8 as part of COPDAC-28 chemotherapy (cycle frequency: Q4W, Group 2)|125 mg/m^2 IV on Days 1 to 5 as part of OEPA induction therapy (cycle frequency: Q4W, Group 2)","MK-3475|Etoposide Phosphate","Pembrolizumab + AVD (Group 1)|Pembrolizumab + COPDAC-28 (Group 2)","\n\n * Group 1: Must have newly diagnosed, pathologically confirmed cHL at Stages IA, IB and IIA without bulky disease. Group 2: Must have newly diagnosed, pathologically confirmed cHL at Stages IIEB, IIIEA,IIIEB, IIIB, IVA and IVB\n * Has measurable disease per investigator assessment\n * Male participants must agree to use approved contraception during the treatment period and for at least 120 days (or longer, if required by the drug label of chemotherapy received by the participant on study) after the last dose of study treatment and refrain from donating sperm during this period\n * Female participants who are not pregnant or breastfeeding, and who are either not a woman of childbearing potential (WOCBP), or are a WOCBP who agrees to use approved contraception during the treatment period and for at least 120 days (or longer, if required by the drug label of chemotherapy received by the participant on study) after the last dose of study treatment\n * Performance status: Lansky Play-Performance Scale â‰¥50 for children up to and including 16 years of age OR Karnofsky score â‰¥50 for participants >16 years of age\n * Has adequate organ function\n\n","\n\n * Has undergone solid organ transplant at any time, or prior allogeneic hematopoietic stem cell transplantation within the last 5 years\n * WOCBP who has a positive urine pregnancy test within 72 hours before the first dose of study treatment\n * Baseline left ventricular ejection fraction value <50% or shortening fraction of <27%\n * Has received prior therapy with an anti-Programmed Death (PD)-1, anti-Programmed Death-Ligand 1 (PD-L1), or anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor or has previously participated in a Merck pembrolizumab (MK-3475) clinical study\n * Has received any prior anti-cancer therapy, monoclonal antibody, chemotherapy, or an investigational agent or device before the first dose of study treatment, or has not recovered from AEs due to previously administered agents\n * Has received a live vaccine within 30 days prior to the first dose of pembrolizumab\n * Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment\n * Has a diagnosis of lymphocyte-predominant Hodgkin Lymphoma (HL)\n * Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of pembrolizumab\n * Has a known additional malignancy that is progressing or requires active treatment\n * Has radiographically detectable central nervous system metastases and/or carcinomatous meningitis as assessed by local site investigator at the time of diagnosis\n * Has severe hypersensitivity (â‰¥Grade 3) to any study therapies including any excipients\n * Has an active autoimmune disease that has required systemic treatment in past 2 years\n * Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis\n * Has an active infection requiring systemic therapy\n * Has a known history of human immunodeficiency virus (HIV) infection\n * Has a known history of Hepatitis B or known active Hepatitis C virus infection\n * Has a known history of active tuberculosis\n * Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator\n * Has known psychiatric or substance abuse disorders that would interfere with cooperating with the requirements of the study\n * Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days (or longer, if required by the drug label of chemotherapy received by the participant on study) after the last dose of trial treatment",{"$nulls":4},"Actual","2018-01-23","Actual","Anticipated","2027-02-13","Anticipated","2020-03-01","2018-01-17","2018-01-17","2020-03-12","No","Programmed Death-1 (PD-1)\nPD1\nProgrammed Death-Ligand 1 (PD-L1)\nPDL1","Interventional","Treatment","Parallel Assignment","None (Open Label)","Non-Randomized","3 Years","25 Years","All",null,"No","Yes\nhttp://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf",null,"URL: http://merckoncologyclinicaltrials.com [http://merckoncologyclinicaltrials.com] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: Merck Oncology Clinical Trials Information",null,"Yes","No",{"$nulls":17},"2017-001123-53|MK-3475-667","EudraCT Number|Merck Protocol Number","Objective Response Rate (ORR) in SER Participants By Risk Group (Low, High) as Assessed by Blinded Independent Central Review (BICR)","ORR is defined as the percentage of SER participants who have a Complete Response (","CR, disappearance of all evidence of disease) or Partial Response (","Rate of Positron Emission Tomography (PET) Scan Negativity in SER Participants By Risk Group (Low, High) After AVD or COPDAC-28 Chemotherapy|Event-Free Survival (EFS) in SER Participants By Risk Group (Low, High) as Assessed by BICR|Overall Survival (OS) in SER Participants By Risk Group (Low, High)|Exposure to Radiotherapy (RT) in SER Participants By Risk Group (Low, High)|Rate of PET Scan Negativity In Group 1 Participants After ABVD Induction Therapy|EFS in Rapid Early Responder (RER) Participants By Risk Group (Low, High) as Assessed by Investigator|OS in RER Participants By Risk Group (Low, High)|Serum Thymus and Activation-Regulated Chemokine (TARC) Levels in SER Participants By Risk Group (Low, High)|Number of SER Participants Experiencing an Adverse Event (AE) By Risk Group (Low, High)|Number of SER Participants Discontinuing Study Treatment Due to AEs By Risk Group (Low, High)","The rate of PET negativity for SER participants is the percentage of participants with PET negativity (defined as Deauville score 1, 2 or 3) after two cycles of AVD (Group 1) or four cycles of COPDAC-28 (Group 2), in combination with pembrolizumab. The Deauville 5-point scoring system is an internationally accepted and utilized five-point scoring system for the Fluorodeoxyglucose (FDG) avidity of a Hodgkin's lymphoma or Non-Hodgkin's lymphoma tumor mass as seen on FDG PET scan: Score 1= No uptake above the background, Score 2= Uptake â‰¤ mediastinum, Score 3= Uptake > mediastinum but â‰¤ liver, Score 4= Uptake moderately increased compared to the liver at any site, Score 5= Uptake markedly increased compared to the liver at any site or new lesions, Score X= New areas of uptake unlikely to be related to lymphoma. In the present study, scores of 1, 2 and 3 are considered to be negative and scores of 4 and 5 are considered to be positive.|EFS is defined as the time from study enrollment to the first documented disease progression or recurrence, or death due to any cause, whichever occurs first. Progression/disease recurrence will be determined by BICR using IWG criteria.|OS is defined as the time from study enrollment to death due to any cause. Participants without documented death will be censored at the date of the last follow-up.|The frequency of RT received by eligible participants (positive PET response, i.e. Deauville score of 4 or 5) will be reported.|The rate of PET negativity for Group 1 participants is the percentage of participants with PET negativity (defined as Deauville score 1, 2 or 3) after two cycles of ABVD induction. The Deauville 5-point scoring system is an internationally accepted and utilized five-point scoring system for the FDG avidity of a Hodgkin's lymphoma or Non-Hodgkin's lymphoma tumor mass as seen on FDG PET scan: Score 1= No uptake above the background, Score 2= Uptake â‰¤ mediastinum, Score 3= Uptake > mediastinum but â‰¤ liver, Score 4= Uptake moderately increased compared to the liver at any site, Score 5= Uptake markedly increased compared to the liver at any site or new lesions, Score X= New areas of uptake unlikely to be related to lymphoma. In the present study, scores of 1, 2 and 3 are considered to be negative and scores of 4 and 5 are considered to be positive.|EFS is defined as the time from study enrollment to the first documented disease progression or recurrence, or death due to any cause, whichever occurs first. Progression/disease recurrence will be determined by the investigator.|Serum TARC levels will be measured and evaluated as a potential biomarker in SER participants by risk group at screening, early, and late response assessments.|An AE is any untoward medical occurrence in a participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. The number of SER participants who experience an AE will be reported for each arm.|An AE is any untoward medical occurrence in a participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. The number of SER participants who discontinue study treatment due to an AE will be reported for each arm.","Up to 5 years","Trialsites@merck.com","Toll Free Number","1-888-577-8839","Barranquilla, Colombia, 080020|Praha 5, Czechia, 150 06|Aviano, Italy, 33081|Barcelona, Spain, 08035|Phoenix, Arizona, United States, 85016|Little Rock, Arkansas, United States, 72202|Anaheim, California, United States, 92806|New Haven, Connecticut, United States, 06510|Hollywood, Florida, United States, 33021|Atlanta, Georgia, United States, 30322-1062|Baltimore, Maryland, United States, 21287|Detroit, Michigan, United States, 48201|Minneapolis, Minnesota, United States, 55404|Las Vegas, Nevada, United States, 89135|Hackensack, New Jersey, United States, 07601|Buffalo, New York, United States, 14263|Chapel Hill, North Carolina, United States, 27514|Cincinnati, Ohio, United States, 45229|Greenville, South Carolina, United States, 29607|Austin, Texas, United States, 78723|Falls Church, Virginia, United States, 22042","Arizona|Arkansas|California|Connecticut|Florida|Georgia|Maryland|Michigan|Minnesota|Nevada|New Jersey|New York|North Carolina|Ohio|South Carolina|Texas|Virginia","Colombia|Czechia|Italy|Spain|United States","Organizacion Clinica Bonnadona-Prevenir S.A.S. ( Site 0529)|Fakultni Nemocnice V Motole ( Site 0356)|Centro Di Riferimento Oncologico Cro ( Site 0404)|Hospital Universitari Vall D Hebron ( Site 0432)|Phoenix Childrens Hospital ( Site 0034)|Arkansas Children's Hospital ( Site 0046)|Kaiser - Orange County ( Site 0084)|Yale Cancer Center ( Site 0061)|Memorial Regional Hospital/Joe Dimaggio Children's Hospital ( Site 0048)|Children's Healthcare Of Atlanta At Egleston ( Site 0033)|Johns Hopkins University ( Site 0025)|Karmanos Cancer Institute ( Site 0002)|Children's Hospitals And Clinics Of Minnesota ( Site 0036)|Alliance For Childhood Diseases ( Site 0064)|Hackensack University Medical Center ( Site 0026)|Roswell Park Cancer Institute ( Site 0040)|Unc Lineberger Comprehensive Cancer ( Site 0044)|Cincinnati Children's Hospital Medical Center ( Site 0035)|St. Francis Hospital Cancer Center ( Site 0001)|Dell Children's Medical Center Of Central Texas ( Site 0058)|Inova Fairfax Hospital ( Site 0031)",{"$nulls":3},"Medical Director","2020-03-12","2020-05-25T16:38:08.756","2020-05-26T17:10:42.972","NCT03407144"]
["5ecbf47111702c1b1b916b19","NCT03407144","2020-03-20","Merck","MRK","Recruiting","Safety and Efficacy of Pembrolizumab (MK-3475) in Children and Young Adults With Classical Hodgkin Lymphoma (MK-3475-667/KEYNOTE-667)","Pembrolizumab|Doxorubicin|Vinblastine|Dacarbazine|Bleomycin|Cyclophosphamide|Vincristine|Prednisolone|Prednisone|Etoposide","PD-1 Inhibitor|TOP2 Inhibitor|Tubulin Inhibitor|Mitosis Inhibitor|P-gp Modulator|DNA Mtase Inhibitor|DNA Synthesis Inhibitor|Immunomodulator|Mitosis Inhibitor|Tubulin Inhibitor|GR Agonist|GR Agonist|Immunosuppressive","Yes","['Bleomycin']","Unknown",null,"Phase 2",2,440,"Anticipated","2018-04-09","2027-02-13","RR","Response Rate",{"$nulls":3},"This study will examine the safety and efficacy of pembrolizumab (MK-3475) in combination with chemotherapy in children and young adults with newly diagnosed classical Hodgkin Lymphoma (cHL) who are slow early responders (SERs) to frontline chemotherapy.","Group 1 will consist of low-risk participants with cHL Stages IA, IB and IIA without bulky disease. Group 2 will consist of high-risk participants with cHL Stages IIEB, IIIEA, IIIEB, IIIB, IVA and IVB.","An Open-label, Uncontrolled, Multicenter Phase II Trial of MK-3475 (Pembrolizumab) in Children and Young Adults With Newly Diagnosed Classical Hodgkin Lymphoma With Inadequate (Slow Early) Response to Frontline Chemotherapy (KEYNOTE 667)","3475-667","Hodgkin Lymphoma","Lymphoma","Oncology Hematological","Oncology","Experimental","Pembrolizumab + AVD (Group 1)|Pembrolizumab + COPDAC-28 (Group 2)","After receiving two 4-week cycles of ABVD (doxorubicin, bleomycin, vinblastine and dacarbazine) induction therapy, SER participants in Group 1 will receive pembrolizumab 2 mg/kg up to a maximum of 200 mg (3 to 17 years of age) or 200 mg (18 to 25 years of age) on Day 1 of each 3-week cycle (Q3W) in combination with two cycles of AVD chemotherapy (doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2 and dacarbazine 375 mg/m^2 on Days 1 and 15; cycle frequency every 4 weeks [Q4W]). All SERs in Group 1 will receive radiotherapy (RT) after completing AVD chemotherapy.|After receiving two 4-week cycles of OEPA (vincristine, etoposide/etopophos, prednisone/prednisolone and doxorubicin) induction therapy, SER participants in Group 2 will receive pembrolizumab 2 mg/kg up to a maximum of 200 mg (3 to 17 years of age) or 200 mg (18 to 25 years of age) Q3W, in combination with 4 cycles of COPDAC-28 chemotherapy (cyclophosphamide 500 mg/m^2 on Days 1 and 8, vincristine 1.5 mg/m^2 with maximum single dose 2 mg on Days 1 and 8, prednisone/prednisolone 40 mg/m^2/day divided in 3 doses on Days 1 to 15, dacarbazine 250 mg/m^2 on Days 1 to 3; cycle frequency Q4W). SERs in Group 2 will receive RT if they have a positive Positron Emission Tomography (PET) response after completing COPDAC-28 chemotherapy.","Biological|Drug","pembrolizumab|doxorubicin|vinblastine|dacarbazine|bleomycin|Radiation: Radiotherapy (RT)|cyclophosphamide|vincristine|prednisone/prednisolone|etoposide","2 mg/kg intravenous (IV) up to a max of 200 mg (3 to 17 years of age) or 200 mg IV (18 to 25 years of age); cycle frequency Q3W|10 units/m^2 IV on Days 1 and 15 as part of ABVD induction therapy (cycle frequency: Q4W, Group 1)|RT administered daily, dose dependent on randomization group and disease response.|500 mg/m^2 IV on days 1 and 8 as part of COPDAC-28 chemotherapy (cycle frequency: Q4W, Group 2)|125 mg/m^2 IV on Days 1 to 5 as part of OEPA induction therapy (cycle frequency: Q4W, Group 2)","MK-3475|Etoposide Phosphate","Pembrolizumab + AVD (Group 1)|Pembrolizumab + COPDAC-28 (Group 2)","\n\n * Group 1: Must have newly diagnosed, pathologically confirmed cHL at Stages IA, IB and IIA without bulky disease. Group 2: Must have newly diagnosed, pathologically confirmed cHL at Stages IIEB, IIIEA,IIIEB, IIIB, IVA and IVB\n * Has measurable disease per investigator assessment\n * Male participants must agree to use approved contraception during the treatment period and for at least 120 days (or longer, if required by the drug label of chemotherapy received by the participant on study) after the last dose of study treatment and refrain from donating sperm during this period\n * Female participants who are not pregnant or breastfeeding, and who are either not a woman of childbearing potential (WOCBP), or are a WOCBP who agrees to use approved contraception during the treatment period and for at least 120 days (or longer, if required by the drug label of chemotherapy received by the participant on study) after the last dose of study treatment\n * Performance status: Lansky Play-Performance Scale â‰¥50 for children up to and including 16 years of age OR Karnofsky score â‰¥50 for participants >16 years of age\n * Has adequate organ function\n\n","\n\n * Has undergone solid organ transplant at any time, or prior allogeneic hematopoietic stem cell transplantation within the last 5 years\n * WOCBP who has a positive urine pregnancy test within 72 hours before the first dose of study treatment\n * Baseline left ventricular ejection fraction value <50% or shortening fraction of <27%\n * Has received prior therapy with an anti-Programmed Death (PD)-1, anti-Programmed Death-Ligand 1 (PD-L1), or anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor or has previously participated in a Merck pembrolizumab (MK-3475) clinical study\n * Has received any prior anti-cancer therapy, monoclonal antibody, chemotherapy, or an investigational agent or device before the first dose of study treatment, or has not recovered from AEs due to previously administered agents\n * Has received a live vaccine within 30 days prior to the first dose of pembrolizumab\n * Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment\n * Has a diagnosis of lymphocyte-predominant Hodgkin Lymphoma (HL)\n * Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of pembrolizumab\n * Has a known additional malignancy that is progressing or requires active treatment\n * Has radiographically detectable central nervous system metastases and/or carcinomatous meningitis as assessed by local site investigator at the time of diagnosis\n * Has severe hypersensitivity (â‰¥Grade 3) to any study therapies including any excipients\n * Has an active autoimmune disease that has required systemic treatment in past 2 years\n * Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis\n * Has an active infection requiring systemic therapy\n * Has a known history of human immunodeficiency virus (HIV) infection\n * Has a known history of Hepatitis B or known active Hepatitis C virus infection\n * Has a known history of active tuberculosis\n * Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator\n * Has known psychiatric or substance abuse disorders that would interfere with cooperating with the requirements of the study\n * Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days (or longer, if required by the drug label of chemotherapy received by the participant on study) after the last dose of trial treatment",{"$nulls":4},"Actual","2018-01-23","Actual","Anticipated","2027-02-13","Anticipated","2020-03-01","2018-01-17","2018-01-17","2020-03-19","No","Programmed Death-1 (PD-1)\nPD1\nProgrammed Death-Ligand 1 (PD-L1)\nPDL1","Interventional","Treatment","Parallel Assignment","None (Open Label)","Non-Randomized","3 Years","25 Years","All",null,"No","Yes\nhttp://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf",null,"URL: http://merckoncologyclinicaltrials.com [http://merckoncologyclinicaltrials.com] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: Merck Oncology Clinical Trials Information",null,"Yes","No",{"$nulls":17},"2017-001123-53|MK-3475-667","EudraCT Number|Merck Protocol Number","Objective Response Rate (ORR) in SER Participants By Risk Group (Low, High) as Assessed by Blinded Independent Central Review (BICR)","ORR is defined as the percentage of SER participants who have a Complete Response (","CR, disappearance of all evidence of disease) or Partial Response (","Rate of Positron Emission Tomography (PET) Scan Negativity in SER Participants By Risk Group (Low, High) After AVD or COPDAC-28 Chemotherapy|Event-Free Survival (EFS) in SER Participants By Risk Group (Low, High) as Assessed by BICR|Overall Survival (OS) in SER Participants By Risk Group (Low, High)|Exposure to Radiotherapy (RT) in SER Participants By Risk Group (Low, High)|Rate of PET Scan Negativity In Group 1 Participants After ABVD Induction Therapy|EFS in Rapid Early Responder (RER) Participants By Risk Group (Low, High) as Assessed by Investigator|OS in RER Participants By Risk Group (Low, High)|Serum Thymus and Activation-Regulated Chemokine (TARC) Levels in SER Participants By Risk Group (Low, High)|Number of SER Participants Experiencing an Adverse Event (AE) By Risk Group (Low, High)|Number of SER Participants Discontinuing Study Treatment Due to AEs By Risk Group (Low, High)","The rate of PET negativity for SER participants is the percentage of participants with PET negativity (defined as Deauville score 1, 2 or 3) after two cycles of AVD (Group 1) or four cycles of COPDAC-28 (Group 2), in combination with pembrolizumab. The Deauville 5-point scoring system is an internationally accepted and utilized five-point scoring system for the Fluorodeoxyglucose (FDG) avidity of a Hodgkin's lymphoma or Non-Hodgkin's lymphoma tumor mass as seen on FDG PET scan: Score 1= No uptake above the background, Score 2= Uptake â‰¤ mediastinum, Score 3= Uptake > mediastinum but â‰¤ liver, Score 4= Uptake moderately increased compared to the liver at any site, Score 5= Uptake markedly increased compared to the liver at any site or new lesions, Score X= New areas of uptake unlikely to be related to lymphoma. In the present study, scores of 1, 2 and 3 are considered to be negative and scores of 4 and 5 are considered to be positive.|EFS is defined as the time from study enrollment to the first documented disease progression or recurrence, or death due to any cause, whichever occurs first. Progression/disease recurrence will be determined by BICR using IWG criteria.|OS is defined as the time from study enrollment to death due to any cause. Participants without documented death will be censored at the date of the last follow-up.|The frequency of RT received by eligible participants (positive PET response, i.e. Deauville score of 4 or 5) will be reported.|The rate of PET negativity for Group 1 participants is the percentage of participants with PET negativity (defined as Deauville score 1, 2 or 3) after two cycles of ABVD induction. The Deauville 5-point scoring system is an internationally accepted and utilized five-point scoring system for the FDG avidity of a Hodgkin's lymphoma or Non-Hodgkin's lymphoma tumor mass as seen on FDG PET scan: Score 1= No uptake above the background, Score 2= Uptake â‰¤ mediastinum, Score 3= Uptake > mediastinum but â‰¤ liver, Score 4= Uptake moderately increased compared to the liver at any site, Score 5= Uptake markedly increased compared to the liver at any site or new lesions, Score X= New areas of uptake unlikely to be related to lymphoma. In the present study, scores of 1, 2 and 3 are considered to be negative and scores of 4 and 5 are considered to be positive.|EFS is defined as the time from study enrollment to the first documented disease progression or recurrence, or death due to any cause, whichever occurs first. Progression/disease recurrence will be determined by the investigator.|Serum TARC levels will be measured and evaluated as a potential biomarker in SER participants by risk group at screening, early, and late response assessments.|An AE is any untoward medical occurrence in a participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. The number of SER participants who experience an AE will be reported for each arm.|An AE is any untoward medical occurrence in a participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. The number of SER participants who discontinue study treatment due to an AE will be reported for each arm.","Up to 5 years","Trialsites@merck.com","Toll Free Number","1-888-577-8839","Barranquilla, Colombia, 080020|Praha 5, Czechia, 150 06|Aviano, Italy, 33081|Barcelona, Spain, 08035|Phoenix, Arizona, United States, 85016|Little Rock, Arkansas, United States, 72202|Anaheim, California, United States, 92806|New Haven, Connecticut, United States, 06510|Hollywood, Florida, United States, 33021|Atlanta, Georgia, United States, 30322-1062|Baltimore, Maryland, United States, 21287|Detroit, Michigan, United States, 48201|Minneapolis, Minnesota, United States, 55404|Las Vegas, Nevada, United States, 89135|Hackensack, New Jersey, United States, 07601|Buffalo, New York, United States, 14263|Chapel Hill, North Carolina, United States, 27514|Cincinnati, Ohio, United States, 45229|Greenville, South Carolina, United States, 29607|Austin, Texas, United States, 78723|Falls Church, Virginia, United States, 22042","Arizona|Arkansas|California|Connecticut|Florida|Georgia|Maryland|Michigan|Minnesota|Nevada|New Jersey|New York|North Carolina|Ohio|South Carolina|Texas|Virginia","Colombia|Czechia|Italy|Spain|United States","Organizacion Clinica Bonnadona-Prevenir S.A.S. ( Site 0529)|Fakultni Nemocnice V Motole ( Site 0356)|Centro Di Riferimento Oncologico Cro ( Site 0404)|Hospital Universitari Vall D Hebron ( Site 0432)|Phoenix Childrens Hospital ( Site 0034)|Arkansas Children's Hospital ( Site 0046)|Kaiser - Orange County ( Site 0084)|Yale Cancer Center ( Site 0061)|Memorial Regional Hospital/Joe Dimaggio Children's Hospital ( Site 0048)|Children's Healthcare Of Atlanta At Egleston ( Site 0033)|Johns Hopkins University ( Site 0025)|Karmanos Cancer Institute ( Site 0002)|Children's Hospitals And Clinics Of Minnesota ( Site 0036)|Alliance For Childhood Diseases ( Site 0064)|Hackensack University Medical Center ( Site 0026)|Roswell Park Cancer Institute ( Site 0040)|Unc Lineberger Comprehensive Cancer ( Site 0044)|Cincinnati Children's Hospital Medical Center ( Site 0035)|St. Francis Hospital Cancer Center ( Site 0001)|Dell Children's Medical Center Of Central Texas ( Site 0058)|Inova Fairfax Hospital ( Site 0031)",{"$nulls":3},"Medical Director","2020-03-19","2020-05-25T16:38:09.375","2020-05-26T17:10:42.972","NCT03407144"]
["5ecbf47111702c1b1b916b1a","NCT03407144","2020-04-30","Merck","MRK","Recruiting","Safety and Efficacy of Pembrolizumab (MK-3475) in Children and Young Adults With Classical Hodgkin Lymphoma (MK-3475-667/KEYNOTE-667)","Pembrolizumab|Doxorubicin|Vinblastine|Dacarbazine|Bleomycin|Cyclophosphamide|Vincristine|Prednisolone|Prednisone|Etoposide","PD-1 Inhibitor|TOP2 Inhibitor|Tubulin Inhibitor|Mitosis Inhibitor|P-gp Modulator|DNA Mtase Inhibitor|DNA Synthesis Inhibitor|Immunomodulator|Mitosis Inhibitor|Tubulin Inhibitor|GR Agonist|GR Agonist|Immunosuppressive","Yes","['Bleomycin']","Unknown",null,"Phase 2",2,440,"Anticipated","2018-04-09","2027-02-13","RR","Response Rate",{"$nulls":3},"This study will examine the safety and efficacy of pembrolizumab (MK-3475) in combination with chemotherapy in children and young adults with newly diagnosed classical Hodgkin Lymphoma (cHL) who are slow early responders (SERs) to frontline chemotherapy.","Group 1 will consist of low-risk participants with cHL Stages IA, IB and IIA without bulky disease. Group 2 will consist of high-risk participants with cHL Stages IIEB, IIIEA, IIIEB, IIIB, IVA and IVB.","An Open-label, Uncontrolled, Multicenter Phase II Trial of MK-3475 (Pembrolizumab) in Children and Young Adults With Newly Diagnosed Classical Hodgkin Lymphoma With Inadequate (Slow Early) Response to Frontline Chemotherapy (KEYNOTE 667)","3475-667","Hodgkin Lymphoma","Lymphoma","Oncology Hematological","Oncology","Experimental","Pembrolizumab + AVD (Group 1)|Pembrolizumab + COPDAC-28 (Group 2)","After receiving two 4-week cycles of ABVD (doxorubicin, bleomycin, vinblastine and dacarbazine) induction therapy, SER participants in Group 1 will receive pembrolizumab 2 mg/kg up to a maximum of 200 mg (3 to 17 years of age) or 200 mg (18 to 25 years of age) on Day 1 of each 3-week cycle (Q3W) in combination with two cycles of AVD chemotherapy (doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2 and dacarbazine 375 mg/m^2 on Days 1 and 15; cycle frequency every 4 weeks [Q4W]). All SERs in Group 1 will receive radiotherapy (RT) after completing AVD chemotherapy.|After receiving two 4-week cycles of OEPA (vincristine, etoposide/etopophos, prednisone/prednisolone and doxorubicin) induction therapy, SER participants in Group 2 will receive pembrolizumab 2 mg/kg up to a maximum of 200 mg (3 to 17 years of age) or 200 mg (18 to 25 years of age) Q3W, in combination with 4 cycles of COPDAC-28 chemotherapy (cyclophosphamide 500 mg/m^2 on Days 1 and 8, vincristine 1.5 mg/m^2 with maximum single dose 2 mg on Days 1 and 8, prednisone/prednisolone 40 mg/m^2/day divided in 3 doses on Days 1 to 15, dacarbazine 250 mg/m^2 on Days 1 to 3; cycle frequency Q4W). SERs in Group 2 will receive RT if they have a positive Positron Emission Tomography (PET) response after completing COPDAC-28 chemotherapy.","Biological|Drug","pembrolizumab|doxorubicin|vinblastine|dacarbazine|bleomycin|Radiation: Radiotherapy (RT)|cyclophosphamide|vincristine|prednisone/prednisolone|etoposide","2 mg/kg intravenous (IV) up to a max of 200 mg (3 to 17 years of age) or 200 mg IV (18 to 25 years of age); cycle frequency Q3W|10 units/m^2 IV on Days 1 and 15 as part of ABVD induction therapy (cycle frequency: Q4W, Group 1)|RT administered daily, dose dependent on randomization group and disease response.|500 mg/m^2 IV on days 1 and 8 as part of COPDAC-28 chemotherapy (cycle frequency: Q4W, Group 2)|125 mg/m^2 IV on Days 1 to 5 as part of OEPA induction therapy (cycle frequency: Q4W, Group 2)","MK-3475|Etoposide Phosphate","Pembrolizumab + AVD (Group 1)|Pembrolizumab + COPDAC-28 (Group 2)","\n\n * Group 1: Must have newly diagnosed, pathologically confirmed cHL at Stages IA, IB and IIA without bulky disease. Group 2: Must have newly diagnosed, pathologically confirmed cHL at Stages IIEB, IIIEA,IIIEB, IIIB, IVA and IVB\n * Has measurable disease per investigator assessment\n * Male participants must agree to use approved contraception during the treatment period and for at least 120 days (or longer, if required by the drug label of chemotherapy received by the participant on study) after the last dose of study treatment and refrain from donating sperm during this period\n * Female participants who are not pregnant or breastfeeding, and who are either not a woman of childbearing potential (WOCBP), or are a WOCBP who agrees to use approved contraception during the treatment period and for at least 120 days (or longer, if required by the drug label of chemotherapy received by the participant on study) after the last dose of study treatment\n * Performance status: Lansky Play-Performance Scale â‰¥50 for children up to and including 16 years of age OR Karnofsky score â‰¥50 for participants >16 years of age\n * Has adequate organ function\n\n","\n\n * Has undergone solid organ transplant at any time, or prior allogeneic hematopoietic stem cell transplantation within the last 5 years\n * WOCBP who has a positive urine pregnancy test within 72 hours before the first dose of study treatment\n * Baseline left ventricular ejection fraction value <50% or shortening fraction of <27%\n * Has received prior therapy with an anti-Programmed Death (PD)-1, anti-Programmed Death-Ligand 1 (PD-L1), or anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor or has previously participated in a Merck pembrolizumab (MK-3475) clinical study\n * Has received any prior anti-cancer therapy, monoclonal antibody, chemotherapy, or an investigational agent or device before the first dose of study treatment, or has not recovered from AEs due to previously administered agents\n * Has received a live vaccine within 30 days prior to the first dose of pembrolizumab\n * Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment\n * Has a diagnosis of lymphocyte-predominant Hodgkin Lymphoma (HL)\n * Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of pembrolizumab\n * Has a known additional malignancy that is progressing or requires active treatment\n * Has radiographically detectable central nervous system metastases and/or carcinomatous meningitis as assessed by local site investigator at the time of diagnosis\n * Has severe hypersensitivity (â‰¥Grade 3) to any study therapies including any excipients\n * Has an active autoimmune disease that has required systemic treatment in past 2 years\n * Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis\n * Has an active infection requiring systemic therapy\n * Has a known history of human immunodeficiency virus (HIV) infection\n * Has a known history of Hepatitis B or known active Hepatitis C virus infection\n * Has a known history of active tuberculosis\n * Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator\n * Has known psychiatric or substance abuse disorders that would interfere with cooperating with the requirements of the study\n * Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days (or longer, if required by the drug label of chemotherapy received by the participant on study) after the last dose of trial treatment",{"$nulls":4},"Actual","2018-01-23","Actual","Anticipated","2027-02-13","Anticipated","2020-04-01","2018-01-17","2018-01-17","2020-04-29","No","Programmed Death-1 (PD-1)\nPD1\nProgrammed Death-Ligand 1 (PD-L1)\nPDL1","Interventional","Treatment","Parallel Assignment","None (Open Label)","Non-Randomized","3 Years","25 Years","All",null,"No","Yes\nhttp://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf",null,"URL: http://merckoncologyclinicaltrials.com [http://merckoncologyclinicaltrials.com] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: Merck Oncology Clinical Trials Information",null,"Yes","No",{"$nulls":17},"2017-001123-53|MK-3475-667","EudraCT Number|Merck Protocol Number","Objective Response Rate (ORR) in SER Participants By Risk Group (Low, High) as Assessed by Blinded Independent Central Review (BICR)","ORR is defined as the percentage of SER participants who have a Complete Response (","CR, disappearance of all evidence of disease) or Partial Response (","Rate of Positron Emission Tomography (PET) Scan Negativity in SER Participants By Risk Group (Low, High) After AVD or COPDAC-28 Chemotherapy|Event-Free Survival (EFS) in SER Participants By Risk Group (Low, High) as Assessed by BICR|Overall Survival (OS) in SER Participants By Risk Group (Low, High)|Exposure to Radiotherapy (RT) in SER Participants By Risk Group (Low, High)|Rate of PET Scan Negativity In Group 1 Participants After ABVD Induction Therapy|EFS in Rapid Early Responder (RER) Participants By Risk Group (Low, High) as Assessed by Investigator|OS in RER Participants By Risk Group (Low, High)|Serum Thymus and Activation-Regulated Chemokine (TARC) Levels in SER Participants By Risk Group (Low, High)|Number of SER Participants Experiencing an Adverse Event (AE) By Risk Group (Low, High)|Number of SER Participants Discontinuing Study Treatment Due to AEs By Risk Group (Low, High)","The rate of PET negativity for SER participants is the percentage of participants with PET negativity (defined as Deauville score 1, 2 or 3) after two cycles of AVD (Group 1) or four cycles of COPDAC-28 (Group 2), in combination with pembrolizumab. The Deauville 5-point scoring system is an internationally accepted and utilized five-point scoring system for the Fluorodeoxyglucose (FDG) avidity of a Hodgkin's lymphoma or Non-Hodgkin's lymphoma tumor mass as seen on FDG PET scan: Score 1= No uptake above the background, Score 2= Uptake â‰¤ mediastinum, Score 3= Uptake > mediastinum but â‰¤ liver, Score 4= Uptake moderately increased compared to the liver at any site, Score 5= Uptake markedly increased compared to the liver at any site or new lesions, Score X= New areas of uptake unlikely to be related to lymphoma. In the present study, scores of 1, 2 and 3 are considered to be negative and scores of 4 and 5 are considered to be positive.|EFS is defined as the time from study enrollment to the first documented disease progression or recurrence, or death due to any cause, whichever occurs first. Progression/disease recurrence will be determined by BICR using IWG criteria.|OS is defined as the time from study enrollment to death due to any cause. Participants without documented death will be censored at the date of the last follow-up.|The frequency of RT received by eligible participants (positive PET response, i.e. Deauville score of 4 or 5) will be reported.|The rate of PET negativity for Group 1 participants is the percentage of participants with PET negativity (defined as Deauville score 1, 2 or 3) after two cycles of ABVD induction. The Deauville 5-point scoring system is an internationally accepted and utilized five-point scoring system for the FDG avidity of a Hodgkin's lymphoma or Non-Hodgkin's lymphoma tumor mass as seen on FDG PET scan: Score 1= No uptake above the background, Score 2= Uptake â‰¤ mediastinum, Score 3= Uptake > mediastinum but â‰¤ liver, Score 4= Uptake moderately increased compared to the liver at any site, Score 5= Uptake markedly increased compared to the liver at any site or new lesions, Score X= New areas of uptake unlikely to be related to lymphoma. In the present study, scores of 1, 2 and 3 are considered to be negative and scores of 4 and 5 are considered to be positive.|EFS is defined as the time from study enrollment to the first documented disease progression or recurrence, or death due to any cause, whichever occurs first. Progression/disease recurrence will be determined by the investigator.|Serum TARC levels will be measured and evaluated as a potential biomarker in SER participants by risk group at screening, early, and late response assessments.|An AE is any untoward medical occurrence in a participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. The number of SER participants who experience an AE will be reported for each arm.|An AE is any untoward medical occurrence in a participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. The number of SER participants who discontinue study treatment due to an AE will be reported for each arm.","Up to 5 years","Trialsites@merck.com","Toll Free Number","1-888-577-8839","Barranquilla, Atlantico, Colombia, 080020|Monteria, Cordoba, Colombia, 230002|Praha 5, Czechia, 150 06|Aviano, Italy, 33081|Barcelona, Barcelona [Barcelona], Spain, 08035|Madrid, Spain, 28009|Phoenix, Arizona, United States, 85016|Little Rock, Arkansas, United States, 72202|Anaheim, California, United States, 92806|Hartford, Connecticut, United States, 06106|Gainesville, Florida, United States, 32610|Atlanta, Georgia, United States, 30322-1062|Baltimore, Maryland, United States, 21287|Detroit, Michigan, United States, 48201|Minneapolis, Minnesota, United States, 55404|Las Vegas, Nevada, United States, 89135|Hackensack, New Jersey, United States, 07601|Buffalo, New York, United States, 14263|Chapel Hill, North Carolina, United States, 27514|Cincinnati, Ohio, United States, 45229|Greenville, South Carolina, United States, 29607|Austin, Texas, United States, 78723|Falls Church, Virginia, United States, 22042","Arizona|Arkansas|California|Connecticut|Florida|Georgia|Maryland|Michigan|Minnesota|Nevada|New Jersey|New York|North Carolina|Ohio|South Carolina|Texas|Virginia","Colombia|Czechia|Italy|Spain|United States","Atlantico Organizacion Clinica Bonnadona-Prevenir S.A.S. ( Site 0529)|Cordoba Oncomedica S.A. ( Site 0527)|Fakultni Nemocnice V Motole ( Site 0356)|Centro Di Riferimento Oncologico Cro ( Site 0404)|Barcelona [Barcelona] Hospital Universitari Vall D Hebron ( Site 0432)|Hospital Infantil Universitario Nino Jesus ( Site 0433)|Phoenix Childrens Hospital ( Site 0034)|Arkansas Children's Hospital ( Site 0046)|Kaiser - Orange County ( Site 0084)|Connecticut Children's Medical Center ( Site 0045)|University Of Florida ( Site 0051)|Children's Healthcare Of Atlanta At Egleston ( Site 0033)|Johns Hopkins University ( Site 0025)|Karmanos Cancer Institute ( Site 0002)|Children's Hospitals And Clinics Of Minnesota ( Site 0036)|Alliance For Childhood Diseases ( Site 0064)|Hackensack University Medical Center ( Site 0026)|Roswell Park Cancer Institute ( Site 0040)|Unc Lineberger Comprehensive Cancer ( Site 0044)|Cincinnati Children's Hospital Medical Center ( Site 0035)|St. Francis Hospital Cancer Center ( Site 0001)|Dell Children's Medical Center Of Central Texas ( Site 0058)|Inova Fairfax Hospital ( Site 0031)",{"$nulls":3},"Medical Director","2020-04-29","2020-05-25T16:38:09.518","2020-05-26T17:10:42.972","NCT03407144"]
["5ecbf471e2561b1b11905e07","NCT03407144","2020-05-15","Merck","MRK","Recruiting","Safety and Efficacy of Pembrolizumab (MK-3475) in Children and Young Adults With Classical Hodgkin Lymphoma (MK-3475-667/KEYNOTE-667)","Pembrolizumab|Doxorubicin|Vinblastine|Dacarbazine|Bleomycin|Cyclophosphamide|Vincristine|Prednisolone|Prednisone|Etoposide","PD-1 Inhibitor|TOP2 Inhibitor|Tubulin Inhibitor|Mitosis Inhibitor|P-gp Modulator|DNA Mtase Inhibitor|DNA Synthesis Inhibitor|Immunomodulator|Mitosis Inhibitor|Tubulin Inhibitor|GR Agonist|GR Agonist|Immunosuppressive","Yes","['Bleomycin']","Unknown",null,"Phase 2",2,440,"Anticipated","2018-04-09","2027-02-13","RR","Response Rate",{"$nulls":3},"This study will examine the safety and efficacy of pembrolizumab (MK-3475) in combination with chemotherapy in children and young adults with newly diagnosed classical Hodgkin Lymphoma (cHL) who are slow early responders (SERs) to frontline chemotherapy.","Group 1 will consist of low-risk participants with cHL Stages IA, IB and IIA without bulky disease. Group 2 will consist of high-risk participants with cHL Stages IIEB, IIIEA, IIIEB, IIIB, IVA and IVB.","An Open-label, Uncontrolled, Multicenter Phase II Trial of MK-3475 (Pembrolizumab) in Children and Young Adults With Newly Diagnosed Classical Hodgkin Lymphoma With Inadequate (Slow Early) Response to Frontline Chemotherapy (KEYNOTE 667)","3475-667","Hodgkin Lymphoma","Lymphoma","Oncology Hematological","Oncology","Experimental","Pembrolizumab + AVD (Group 1)|Pembrolizumab + COPDAC-28 (Group 2)","After receiving two 4-week cycles of ABVD (doxorubicin, bleomycin, vinblastine and dacarbazine) induction therapy, SER participants in Group 1 will receive pembrolizumab 2 mg/kg up to a maximum of 200 mg (3 to 17 years of age) or 200 mg (18 to 25 years of age) on Day 1 of each 3-week cycle (Q3W) in combination with two cycles of AVD chemotherapy (doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2 and dacarbazine 375 mg/m^2 on Days 1 and 15; cycle frequency every 4 weeks [Q4W]). All SERs in Group 1 will receive radiotherapy (RT) after completing AVD chemotherapy.|After receiving two 4-week cycles of OEPA (vincristine, etoposide/etopophos, prednisone/prednisolone and doxorubicin) induction therapy, SER participants in Group 2 will receive pembrolizumab 2 mg/kg up to a maximum of 200 mg (3 to 17 years of age) or 200 mg (18 to 25 years of age) Q3W, in combination with 4 cycles of COPDAC-28 chemotherapy (cyclophosphamide 500 mg/m^2 on Days 1 and 8, vincristine 1.5 mg/m^2 with maximum single dose 2 mg on Days 1 and 8, prednisone/prednisolone 40 mg/m^2/day divided in 3 doses on Days 1 to 15, dacarbazine 250 mg/m^2 on Days 1 to 3; cycle frequency Q4W). SERs in Group 2 will receive RT if they have a positive Positron Emission Tomography (PET) response after completing COPDAC-28 chemotherapy.","Biological|Drug","pembrolizumab|doxorubicin|vinblastine|dacarbazine|bleomycin|Radiation: Radiotherapy (RT)|cyclophosphamide|vincristine|prednisone/prednisolone|etoposide","2 mg/kg intravenous (IV) up to a max of 200 mg (3 to 17 years of age) or 200 mg IV (18 to 25 years of age); cycle frequency Q3W|10 units/m^2 IV on Days 1 and 15 as part of ABVD induction therapy (cycle frequency: Q4W, Group 1)|RT administered daily, dose dependent on randomization group and disease response.|500 mg/m^2 IV on days 1 and 8 as part of COPDAC-28 chemotherapy (cycle frequency: Q4W, Group 2)|125 mg/m^2 IV on Days 1 to 5 as part of OEPA induction therapy (cycle frequency: Q4W, Group 2)","MK-3475|Etoposide Phosphate","Pembrolizumab + AVD (Group 1)|Pembrolizumab + COPDAC-28 (Group 2)","\n\n * Group 1: Must have newly diagnosed, pathologically confirmed cHL at Stages IA, IB and IIA without bulky disease. Group 2: Must have newly diagnosed, pathologically confirmed cHL at Stages IIEB, IIIEA,IIIEB, IIIB, IVA and IVB\n * Has measurable disease per investigator assessment\n * Male participants must agree to use approved contraception during the treatment period and for at least 120 days (or longer, if required by the drug label of chemotherapy received by the participant on study) after the last dose of study treatment and refrain from donating sperm during this period\n * Female participants who are not pregnant or breastfeeding, and who are either not a woman of childbearing potential (WOCBP), or are a WOCBP who agrees to use approved contraception during the treatment period and for at least 120 days (or longer, if required by the drug label of chemotherapy received by the participant on study) after the last dose of study treatment\n * Performance status: Lansky Play-Performance Scale â‰¥50 for children up to and including 16 years of age OR Karnofsky score â‰¥50 for participants >16 years of age\n * Has adequate organ function\n\n","\n\n * Has undergone solid organ transplant at any time, or prior allogeneic hematopoietic stem cell transplantation within the last 5 years\n * WOCBP who has a positive urine pregnancy test within 72 hours before the first dose of study treatment\n * Baseline left ventricular ejection fraction value <50% or shortening fraction of <27%\n * Has received prior therapy with an anti-Programmed Death (PD)-1, anti-Programmed Death-Ligand 1 (PD-L1), or anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor or has previously participated in a Merck pembrolizumab (MK-3475) clinical study\n * Has received any prior anti-cancer therapy, monoclonal antibody, chemotherapy, or an investigational agent or device before the first dose of study treatment, or has not recovered from AEs due to previously administered agents\n * Has received a live vaccine within 30 days prior to the first dose of pembrolizumab\n * Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment\n * Has a diagnosis of lymphocyte-predominant Hodgkin Lymphoma (HL)\n * Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of pembrolizumab\n * Has a known additional malignancy that is progressing or requires active treatment\n * Has radiographically detectable central nervous system metastases and/or carcinomatous meningitis as assessed by local site investigator at the time of diagnosis\n * Has severe hypersensitivity (â‰¥Grade 3) to any study therapies including any excipients\n * Has an active autoimmune disease that has required systemic treatment in past 2 years\n * Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis\n * Has an active infection requiring systemic therapy\n * Has a known history of human immunodeficiency virus (HIV) infection\n * Has a known history of Hepatitis B or known active Hepatitis C virus infection\n * Has a known history of active tuberculosis\n * Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator\n * Has known psychiatric or substance abuse disorders that would interfere with cooperating with the requirements of the study\n * Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days (or longer, if required by the drug label of chemotherapy received by the participant on study) after the last dose of trial treatment",{"$nulls":4},"Actual","2018-01-23","Actual","Anticipated","2027-02-13","Anticipated","2020-05-01","2018-01-17","2018-01-17","2020-05-14","No","Programmed Death-1 (PD-1)\nPD1\nProgrammed Death-Ligand 1 (PD-L1)\nPDL1","Interventional","Treatment","Parallel Assignment","None (Open Label)","Non-Randomized","3 Years","25 Years","All",null,"No","Yes\nhttp://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf",null,"URL: http://merckoncologyclinicaltrials.com [http://merckoncologyclinicaltrials.com] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: Merck Oncology Clinical Trials Information",null,"Yes","No",{"$nulls":17},"2017-001123-53|MK-3475-667","EudraCT Number|Merck Protocol Number","Objective Response Rate (ORR) in SER Participants By Risk Group (Low, High) as Assessed by Blinded Independent Central Review (BICR)","ORR is defined as the percentage of SER participants who have a Complete Response (","CR, disappearance of all evidence of disease) or Partial Response (","Rate of Positron Emission Tomography (PET) Scan Negativity in SER Participants By Risk Group (Low, High) After AVD or COPDAC-28 Chemotherapy|Event-Free Survival (EFS) in SER Participants By Risk Group (Low, High) as Assessed by BICR|Overall Survival (OS) in SER Participants By Risk Group (Low, High)|Exposure to Radiotherapy (RT) in SER Participants By Risk Group (Low, High)|Rate of PET Scan Negativity In Group 1 Participants After ABVD Induction Therapy|EFS in Rapid Early Responder (RER) Participants By Risk Group (Low, High) as Assessed by Investigator|OS in RER Participants By Risk Group (Low, High)|Serum Thymus and Activation-Regulated Chemokine (TARC) Levels in SER Participants By Risk Group (Low, High)|Number of SER Participants Experiencing an Adverse Event (AE) By Risk Group (Low, High)|Number of SER Participants Discontinuing Study Treatment Due to AEs By Risk Group (Low, High)","The rate of PET negativity for SER participants is the percentage of participants with PET negativity (defined as Deauville score 1, 2 or 3) after two cycles of AVD (Group 1) or four cycles of COPDAC-28 (Group 2), in combination with pembrolizumab. The Deauville 5-point scoring system is an internationally accepted and utilized five-point scoring system for the Fluorodeoxyglucose (FDG) avidity of a Hodgkin's lymphoma or Non-Hodgkin's lymphoma tumor mass as seen on FDG PET scan: Score 1= No uptake above the background, Score 2= Uptake â‰¤ mediastinum, Score 3= Uptake > mediastinum but â‰¤ liver, Score 4= Uptake moderately increased compared to the liver at any site, Score 5= Uptake markedly increased compared to the liver at any site or new lesions, Score X= New areas of uptake unlikely to be related to lymphoma. In the present study, scores of 1, 2 and 3 are considered to be negative and scores of 4 and 5 are considered to be positive.|EFS is defined as the time from study enrollment to the first documented disease progression or recurrence, or death due to any cause, whichever occurs first. Progression/disease recurrence will be determined by BICR using IWG criteria.|OS is defined as the time from study enrollment to death due to any cause. Participants without documented death will be censored at the date of the last follow-up.|The frequency of RT received by eligible participants (positive PET response, i.e. Deauville score of 4 or 5) will be reported.|The rate of PET negativity for Group 1 participants is the percentage of participants with PET negativity (defined as Deauville score 1, 2 or 3) after two cycles of ABVD induction. The Deauville 5-point scoring system is an internationally accepted and utilized five-point scoring system for the FDG avidity of a Hodgkin's lymphoma or Non-Hodgkin's lymphoma tumor mass as seen on FDG PET scan: Score 1= No uptake above the background, Score 2= Uptake â‰¤ mediastinum, Score 3= Uptake > mediastinum but â‰¤ liver, Score 4= Uptake moderately increased compared to the liver at any site, Score 5= Uptake markedly increased compared to the liver at any site or new lesions, Score X= New areas of uptake unlikely to be related to lymphoma. In the present study, scores of 1, 2 and 3 are considered to be negative and scores of 4 and 5 are considered to be positive.|EFS is defined as the time from study enrollment to the first documented disease progression or recurrence, or death due to any cause, whichever occurs first. Progression/disease recurrence will be determined by the investigator.|Serum TARC levels will be measured and evaluated as a potential biomarker in SER participants by risk group at screening, early, and late response assessments.|An AE is any untoward medical occurrence in a participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. The number of SER participants who experience an AE will be reported for each arm.|An AE is any untoward medical occurrence in a participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. The number of SER participants who discontinue study treatment due to an AE will be reported for each arm.","Up to 5 years","Trialsites@merck.com","Toll Free Number","1-888-577-8839","Barranquilla, Atlantico, Colombia, 080020|Monteria, Cordoba, Colombia, 230002|Praha 5, Czechia, 150 06|Aviano, Pordenone, Italy, 33081|Roma, Italy, 00161|Barcelona, Barcelona [Barcelona], Spain, 08035|Madrid, Spain, 28009|Phoenix, Arizona, United States, 85016|Little Rock, Arkansas, United States, 72202|Anaheim, California, United States, 92806|Hartford, Connecticut, United States, 06106|Gainesville, Florida, United States, 32610|Atlanta, Georgia, United States, 30322-1062|Baltimore, Maryland, United States, 21287|Detroit, Michigan, United States, 48201|Minneapolis, Minnesota, United States, 55404|Saint Louis, Missouri, United States, 63110|Las Vegas, Nevada, United States, 89135|Hackensack, New Jersey, United States, 07601|Buffalo, New York, United States, 14263|Chapel Hill, North Carolina, United States, 27514|Cincinnati, Ohio, United States, 45229|Greenville, South Carolina, United States, 29607|Austin, Texas, United States, 78723|Falls Church, Virginia, United States, 22042","Arizona|Arkansas|California|Connecticut|Florida|Georgia|Maryland|Michigan|Minnesota|Missouri|Nevada|New Jersey|New York|North Carolina|Ohio|South Carolina|Texas|Virginia","Colombia|Czechia|Italy|Spain|United States","Atlantico Organizacion Clinica Bonnadona-Prevenir S.A.S. ( Site 0529)|Cordoba Oncomedica S.A. ( Site 0527)|Fakultni Nemocnice V Motole ( Site 0356)|Pordenone Centro Di Riferimento Oncologico Cro ( Site 0404)|Universita Degli Studi Di Roma La Sapienza ( Site 0403)|Barcelona [Barcelona] Hospital Universitari Vall D Hebron ( Site 0432)|Hospital Infantil Universitario Nino Jesus ( Site 0433)|Phoenix Childrens Hospital ( Site 0034)|Arkansas Children's Hospital ( Site 0046)|Kaiser - Orange County ( Site 0084)|Connecticut Children's Medical Center ( Site 0045)|University Of Florida ( Site 0051)|Children's Healthcare Of Atlanta At Egleston ( Site 0033)|Johns Hopkins University ( Site 0025)|Karmanos Cancer Institute ( Site 0002)|Children's Hospitals And Clinics Of Minnesota ( Site 0036)|St. Louis Children's Hospital ( Site 0038)|Alliance For Childhood Diseases ( Site 0064)|Hackensack University Medical Center ( Site 0026)|Roswell Park Cancer Institute ( Site 0040)|Unc Lineberger Comprehensive Cancer ( Site 0044)|Cincinnati Children's Hospital Medical Center ( Site 0035)|St. Francis Hospital Cancer Center ( Site 0001)|Dell Children's Medical Center Of Central Texas ( Site 0058)|Inova Fairfax Hospital ( Site 0031)",{"$nulls":3},"Medical Director","2020-05-14","2020-05-25T16:38:09.702","2020-05-26T17:10:42.972","NCT03407144"]
["5ecbf47211702c1b1b916b1c","NCT03407170","2018-02-09","Merck","MRK","Recruiting","Immunologic Determinants of Response to Pembrolizumab (MK-3475) in Advanced Melanoma (MK-3475-161/KEYNOTE-161)","Pembrolizumab","PD-1 Inhibitor","No",null,"No",null,"Phase 2",1,60,"Anticipated","2018-03-01","2021-12-13",{"$nulls":5},"In this study, participants with advanced melanoma will be treated with pembrolizumab (MK-3475) and their tumors and blood will be analyzed for changes related to pembrolizumab therapy.",null,"An Open-Label, Phase II Study to Determine the Immunologic Correlates of Pembrolizumab-Mediated Tumor Regression in Subjects With Advanced Melanoma (KEYNOTE-161)","3475-161","Advanced Melanoma","Noma|Melanoma","Mouth Diseases|Oncology Solid Tumor","Ear, Nose and Throat|Oncology","Experimental","Pembrolizumab","Participants receive pembrolizumab 200 mg by intravenous (IV) infusion every 3 weeks (Q3W) for up to 24 months","Biological","pembrolizumab","200 mg by IV infusion Q3W for up to 24 months","KEYTRUDAÂ® | MK-3475","Pembrolizumab","\n\n * Has a histologically confirmed diagnosis of unresectable stage III or metastatic melanoma not amenable to local therapy\n * Has testing for a BRAF mutation prior to study entry\n * Has measurable disease per RECIST 1.1 as assessed by the investigator/radiology\n * Has resolution of toxic effect(s) of the most recent prior chemotherapy to Grade 1 or less (except alopecia). If the participant received major surgery or radiation therapy of >30 Gray units, they must have recovered from the toxicity and/or complications from the intervention\n * Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 10 days of study start\n * Is not pregnant or breastfeeding\n * Female participants of child-bearing potential must be willing to use effective contraception starting with the screening visit through 120 days after the last dose of study therapy\n\n","\n\n * Has disease that is suitable for local therapy administered with curative intent\n * Has a history of interstitial lung disease\n * Has a positive pregnancy test within 72 hours before the first dose of study therapy\n * Has received prior therapy with an anti-Programmed Cell Death Protein 1 (PD-1), anti-Programmed Cell Death-Ligand 1 (PD-L1), anti-Programmed Cell Death-Ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137)\n * Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to study start\n * Has received prior radiotherapy within 2 weeks of start of study therapy\n * Has received a live vaccine within 30 days prior to the first dose of study therapy\n * Has received transfusion of blood products (including platelets or red blood cells) or administration of colony stimulating factors (including granulocyte colony stimulating factor [G-CSF], granulocyte macrophage colony stimulating factor [GMCSF] or recombinant erythropoietin) within 4 weeks prior to study start\n * Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study therapy\n * Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study therapy\n * Has a known additional malignancy that is progressing or has required active treatment within the past 3 years with the exception of basal cell and squamous cell carcinoma of the skin, transitional cell carcinoma of urothelial cancer, or carcinoma in situ (eg, breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy\n * Has known active CNS metastases and/or carcinomatous meningitis\n * Has severe hypersensitivity (â‰¥Grade 3) to pembrolizumab and/or any of its excipients\n * Has an active autoimmune disease that has required systemic treatment in past 2 years\n * Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis\n * Has an active infection requiring systemic therapy\n * Has a known history of human immunodeficiency virus (HIV) infection\n * Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection\n * Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator\n * Has known psychiatric or substance abuse disorders that would interfere with cooperating with the requirements of the study\n * Is pregnant or breastfeeding or expecting to conceive or father children starting with the screening visit through 120 days after the last dose of study therapy",{"$nulls":4},"Actual","2018-01-23","Actual","Anticipated","2021-12-13","Anticipated","2018-02-01","2018-01-18","2018-01-18","2018-02-08","No","Programmed Cell Death-1 (PD-1)\nPD1\nProgrammed Cell Death-Ligand 1 (PD-L1)\nProgrammed Cell Death-Ligand 2 (PD-L2)\nPDL1\nPDL2","Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"MK-3475-161","Merck Protocol Number","Mean Fraction of Cytotoxic T-lymphocytes (FCT) for Participants with Response versus Participants with Progression|Average Specific Cytotoxic T-lymphocyte Frequency Ratio (ASCTFR) for Participants with Response vs Participants with Progression|Change in Baseline of FCT for Participants With Response Versus Participants With Progression","FCT is defined as the fraction of CD8+ T-cells expressing a predefined single-cell RNA gene signature to the total tumor infiltrating CD8+T-cells isolated from tumor biopsies.|ASCTFR is defined as the arithmetic average of the log^10 ratio of the frequency of individual specific cytotoxic T-Cell Receptor (TCR) clones of on-treatment to pre-treatment.|The fold change from baseline in FCT. FCT is defined as the fraction of CD8+ T-cells expressing a predefined single-cell RNA gene signature to the total tumor infiltrating CD8+T-cells isolated from tumor biopsies.","Up to 24 months|Baseline and Month 24","Adverse Events (AEs)|Treatment Discontinuations due to AEs|Overall Response Rate (ORR) per Immune-related Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1|Progression-free Survival (PFS) per RECIST Version 1.1|Overall Survival (OS)|Neoepitope Burden|Antigenic Determinants of Highly-functional CD8 + T-cell Clones","Number of participants experiencing an AE defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered related to the study treatment.|Number of participants discontinuing study drug due to an AE.|ORR is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: â‰¥30% decrease in the sum of diameters of target lesions) per RECIST Version 1.1 as assessed by the investigator.|PFS is defined as the time from start of treatment to the first documented progressive disease (PD) or death due to any cause, whichever occurs first, per RECIST Version 1.1 as assessed by the investigator..|OS is defined as the time from the start of treatment to death due to any cause.|Neoepitope sequencing will be generated based on single cell RNA sequencing (scRNAseq), whole exome sequencing, and an epitope prediction algorithm to obtain neoepitope burden.|TCRs from CD8+ T-cell clones will be identified by scRNAseq and their killing function will be confirmed by TCR-transduced T-cells recognizing autologous tumor-derived cell lines.","Up to 27 months|Up to 24 months","Trialsites@merck.com","Toll Free Number","1-888-577-8839","Boston, Massachusetts, United States, 02215","Massachusetts","United States","Dana Farber Cancer Institute ( Site 0101)",{"$nulls":3},"Medical Director","2018-02-08","2020-05-25T16:38:10.737","2020-05-26T17:10:42.972","NCT03407170"]
["5ecbf472e2561b1b11905e09","NCT03407170","2018-03-19","Merck","MRK","Recruiting","Immunologic Determinants of Response to Pembrolizumab (MK-3475) in Advanced Melanoma (MK-3475-161/KEYNOTE-161)","Pembrolizumab","PD-1 Inhibitor","No",null,"No",null,"Phase 2",1,60,"Anticipated","2018-04-06","2021-12-13",{"$nulls":5},"In this study, participants with advanced melanoma will be treated with pembrolizumab (MK-3475) and their tumors and blood will be analyzed for changes related to pembrolizumab therapy.",null,"An Open-Label, Phase II Study to Determine the Immunologic Correlates of Pembrolizumab-Mediated Tumor Regression in Subjects With Advanced Melanoma (KEYNOTE-161)","3475-161","Advanced Melanoma","Noma|Melanoma","Mouth Diseases|Oncology Solid Tumor","Ear, Nose and Throat|Oncology","Experimental","Pembrolizumab","Participants receive pembrolizumab 200 mg by intravenous (IV) infusion every 3 weeks (Q3W) for up to 24 months","Biological","pembrolizumab","200 mg by IV infusion Q3W for up to 24 months","KEYTRUDAÂ® | MK-3475","Pembrolizumab","\n\n * Has a histologically confirmed diagnosis of unresectable stage III or metastatic melanoma not amenable to local therapy\n * Has testing for a BRAF mutation prior to study entry\n * Has measurable disease per RECIST 1.1 as assessed by the investigator/radiology\n * Has resolution of toxic effect(s) of the most recent prior chemotherapy to Grade 1 or less (except alopecia). If the participant received major surgery or radiation therapy of >30 Gray units, they must have recovered from the toxicity and/or complications from the intervention\n * Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 10 days of study start\n * Is not pregnant or breastfeeding\n * Female participants of child-bearing potential must be willing to use effective contraception starting with the screening visit through 120 days after the last dose of study therapy\n\n","\n\n * Has disease that is suitable for local therapy administered with curative intent\n * Has a history of interstitial lung disease\n * Has a positive pregnancy test within 72 hours before the first dose of study therapy\n * Has received prior therapy with an anti-Programmed Cell Death Protein 1 (PD-1), anti-Programmed Cell Death-Ligand 1 (PD-L1), anti-Programmed Cell Death-Ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137)\n * Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to study start\n * Has received prior radiotherapy within 2 weeks of start of study therapy\n * Has received a live vaccine within 30 days prior to the first dose of study therapy\n * Has received transfusion of blood products (including platelets or red blood cells) or administration of colony stimulating factors (including granulocyte colony stimulating factor [G-CSF], granulocyte macrophage colony stimulating factor [GMCSF] or recombinant erythropoietin) within 4 weeks prior to study start\n * Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study therapy\n * Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study therapy\n * Has a known additional malignancy that is progressing or has required active treatment within the past 3 years with the exception of basal cell and squamous cell carcinoma of the skin, transitional cell carcinoma of urothelial cancer, or carcinoma in situ (eg, breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy\n * Has known active CNS metastases and/or carcinomatous meningitis\n * Has severe hypersensitivity (â‰¥Grade 3) to pembrolizumab and/or any of its excipients\n * Has an active autoimmune disease that has required systemic treatment in past 2 years\n * Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis\n * Has an active infection requiring systemic therapy\n * Has a known history of human immunodeficiency virus (HIV) infection\n * Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection\n * Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator\n * Has known psychiatric or substance abuse disorders that would interfere with cooperating with the requirements of the study\n * Is pregnant or breastfeeding or expecting to conceive or father children starting with the screening visit through 120 days after the last dose of study therapy",{"$nulls":4},"Actual","2018-01-23","Actual","Anticipated","2021-12-13","Anticipated","2018-03-01","2018-01-18","2018-01-18","2018-03-16","No","Programmed Cell Death-1 (PD-1)\nPD1\nProgrammed Cell Death-Ligand 1 (PD-L1)\nProgrammed Cell Death-Ligand 2 (PD-L2)\nPDL1\nPDL2","Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"MK-3475-161","Merck Protocol Number","Mean Fraction of Cytotoxic T-lymphocytes (FCT) for Participants with Response versus Participants with Progression|Average Specific Cytotoxic T-lymphocyte Frequency Ratio (ASCTFR) for Participants with Response vs Participants with Progression|Change in Baseline of FCT for Participants With Response Versus Participants With Progression","FCT is defined as the fraction of CD8+ T-cells expressing a predefined single-cell RNA gene signature to the total tumor infiltrating CD8+T-cells isolated from tumor biopsies.|ASCTFR is defined as the arithmetic average of the log^10 ratio of the frequency of individual specific cytotoxic T-Cell Receptor (TCR) clones of on-treatment to pre-treatment.|The fold change from baseline in FCT. FCT is defined as the fraction of CD8+ T-cells expressing a predefined single-cell RNA gene signature to the total tumor infiltrating CD8+T-cells isolated from tumor biopsies.","Up to 24 months|Baseline and Month 24","Adverse Events (AEs)|Treatment Discontinuations due to AEs|Overall Response Rate (ORR) per Immune-related Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1|Progression-free Survival (PFS) per RECIST Version 1.1|Overall Survival (OS)|Neoepitope Burden|Antigenic Determinants of Highly-functional CD8 + T-cell Clones","Number of participants experiencing an AE defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered related to the study treatment.|Number of participants discontinuing study drug due to an AE.|ORR is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: â‰¥30% decrease in the sum of diameters of target lesions) per RECIST Version 1.1 as assessed by the investigator.|PFS is defined as the time from start of treatment to the first documented progressive disease (PD) or death due to any cause, whichever occurs first, per RECIST Version 1.1 as assessed by the investigator..|OS is defined as the time from the start of treatment to death due to any cause.|Neoepitope sequencing will be generated based on single cell RNA sequencing (scRNAseq), whole exome sequencing, and an epitope prediction algorithm to obtain neoepitope burden.|TCRs from CD8+ T-cell clones will be identified by scRNAseq and their killing function will be confirmed by TCR-transduced T-cells recognizing autologous tumor-derived cell lines.","Up to 27 months|Up to 24 months","Trialsites@merck.com","Toll Free Number","1-888-577-8839","Boston, Massachusetts, United States, 02215","Massachusetts","United States","Dana Farber Cancer Institute ( Site 0101)",{"$nulls":3},"Medical Director","2018-03-16","2020-05-25T16:38:10.645","2020-05-26T17:10:42.972","NCT03407170"]
["5ecbf472307e3d1b1f8d9da0","NCT03407170","2018-05-11","Merck","MRK","Recruiting","Immunologic Determinants of Response to Pembrolizumab (MK-3475) in Advanced Melanoma (MK-3475-161/KEYNOTE-161)","Pembrolizumab","PD-1 Inhibitor","No",null,"No",null,"Phase 2",1,60,"Anticipated","2018-05-31","2021-12-13",{"$nulls":5},"In this study, participants with advanced melanoma will be treated with pembrolizumab (MK-3475) and their tumors and blood will be analyzed for changes related to pembrolizumab therapy.",null,"An Open-Label, Phase II Study to Determine the Immunologic Correlates of Pembrolizumab-Mediated Tumor Regression in Subjects With Advanced Melanoma (KEYNOTE-161)","3475-161","Advanced Melanoma","Noma|Melanoma","Mouth Diseases|Oncology Solid Tumor","Ear, Nose and Throat|Oncology","Experimental","Pembrolizumab","Participants receive pembrolizumab 200 mg by intravenous (IV) infusion every 3 weeks (Q3W) for up to 24 months","Biological","pembrolizumab","200 mg by IV infusion Q3W for up to 24 months","KEYTRUDAÂ® | MK-3475","Pembrolizumab","\n\n * Has a histologically confirmed diagnosis of unresectable stage III or metastatic melanoma not amenable to local therapy\n * Has testing for a BRAF mutation prior to study entry\n * Has measurable disease per RECIST 1.1 as assessed by the investigator/radiology\n * Has resolution of toxic effect(s) of the most recent prior chemotherapy to Grade 1 or less (except alopecia). If the participant received major surgery or radiation therapy of >30 Gray units, they must have recovered from the toxicity and/or complications from the intervention\n * Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 10 days of study start\n * Is not pregnant or breastfeeding\n * Female participants of child-bearing potential must be willing to use effective contraception starting with the screening visit through 120 days after the last dose of study therapy\n\n","\n\n * Has disease that is suitable for local therapy administered with curative intent\n * Has a history of interstitial lung disease\n * Has a positive pregnancy test within 72 hours before the first dose of study therapy\n * Has received prior therapy with an anti-Programmed Cell Death Protein 1 (PD-1), anti-Programmed Cell Death-Ligand 1 (PD-L1), anti-Programmed Cell Death-Ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137)\n * Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to study start\n * Has received prior radiotherapy within 2 weeks of start of study therapy\n * Has received a live vaccine within 30 days prior to the first dose of study therapy\n * Has received transfusion of blood products (including platelets or red blood cells) or administration of colony stimulating factors (including granulocyte colony stimulating factor [G-CSF], granulocyte macrophage colony stimulating factor [GMCSF] or recombinant erythropoietin) within 4 weeks prior to study start\n * Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study therapy\n * Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study therapy\n * Has a known additional malignancy that is progressing or has required active treatment within the past 3 years with the exception of basal cell and squamous cell carcinoma of the skin, transitional cell carcinoma of urothelial cancer, or carcinoma in situ (eg, breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy\n * Has known active CNS metastases and/or carcinomatous meningitis\n * Has severe hypersensitivity (â‰¥Grade 3) to pembrolizumab and/or any of its excipients\n * Has an active autoimmune disease that has required systemic treatment in past 2 years\n * Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis\n * Has an active infection requiring systemic therapy\n * Has a known history of human immunodeficiency virus (HIV) infection\n * Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection\n * Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator\n * Has known psychiatric or substance abuse disorders that would interfere with cooperating with the requirements of the study\n * Is pregnant or breastfeeding or expecting to conceive or father children starting with the screening visit through 120 days after the last dose of study therapy",{"$nulls":4},"Actual","2018-01-23","Actual","Anticipated","2021-12-13","Anticipated","2018-05-01","2018-01-18","2018-01-18","2018-05-09","No","Programmed Cell Death-1 (PD-1)\nPD1\nProgrammed Cell Death-Ligand 1 (PD-L1)\nProgrammed Cell Death-Ligand 2 (PD-L2)\nPDL1\nPDL2","Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"MK-3475-161","Merck Protocol Number","Mean Fraction of Cytotoxic T-lymphocytes (FCT) for Participants with Response versus Participants with Progression|Average Specific Cytotoxic T-lymphocyte Frequency Ratio (ASCTFR) for Participants with Response vs Participants with Progression|Change in Baseline of FCT for Participants With Response Versus Participants With Progression","FCT is defined as the fraction of CD8+ T-cells expressing a predefined single-cell RNA gene signature to the total tumor infiltrating CD8+T-cells isolated from tumor biopsies.|ASCTFR is defined as the arithmetic average of the log^10 ratio of the frequency of individual specific cytotoxic T-Cell Receptor (TCR) clones of on-treatment to pre-treatment.|The fold change from baseline in FCT. FCT is defined as the fraction of CD8+ T-cells expressing a predefined single-cell RNA gene signature to the total tumor infiltrating CD8+T-cells isolated from tumor biopsies.","Up to 24 months|Baseline and Month 24","Adverse Events (AEs)|Treatment Discontinuations due to AEs|Overall Response Rate (ORR) per Immune-related Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1|Progression-free Survival (PFS) per RECIST Version 1.1|Overall Survival (OS)|Neoepitope Burden|Antigenic Determinants of Highly-functional CD8 + T-cell Clones","Number of participants experiencing an AE defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered related to the study treatment.|Number of participants discontinuing study drug due to an AE.|ORR is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: â‰¥30% decrease in the sum of diameters of target lesions) per RECIST Version 1.1 as assessed by the investigator.|PFS is defined as the time from start of treatment to the first documented progressive disease (PD) or death due to any cause, whichever occurs first, per RECIST Version 1.1 as assessed by the investigator..|OS is defined as the time from the start of treatment to death due to any cause.|Neoepitope sequencing will be generated based on single cell RNA sequencing (scRNAseq), whole exome sequencing, and an epitope prediction algorithm to obtain neoepitope burden.|TCRs from CD8+ T-cell clones will be identified by scRNAseq and their killing function will be confirmed by TCR-transduced T-cells recognizing autologous tumor-derived cell lines.","Up to 27 months|Up to 24 months","Trialsites@merck.com","Toll Free Number","1-888-577-8839","Boston, Massachusetts, United States, 02114","Massachusetts","United States","Massachusetts General Hospital ( Site 0102)",{"$nulls":3},"Medical Director","2018-05-09","2020-05-25T16:38:10.765","2020-05-26T17:10:42.972","NCT03407170"]
["5ecbf47211702c1b1b916b1d","NCT03407170","2018-06-08","Merck","MRK","Recruiting","Immunologic Determinants of Response to Pembrolizumab (MK-3475) in Advanced Melanoma (MK-3475-161/KEYNOTE-161)","Pembrolizumab","PD-1 Inhibitor","No",null,"No",null,"Phase 2",1,60,"Anticipated","2018-06-15","2021-12-13",{"$nulls":5},"In this study, participants with advanced melanoma will be treated with pembrolizumab (MK-3475) and their tumors and blood will be analyzed for changes related to pembrolizumab therapy.",null,"An Open-Label, Phase II Study to Determine the Immunologic Correlates of Pembrolizumab-Mediated Tumor Regression in Subjects With Advanced Melanoma (KEYNOTE-161)","3475-161","Advanced Melanoma","Noma|Melanoma","Mouth Diseases|Oncology Solid Tumor","Ear, Nose and Throat|Oncology","Experimental","Pembrolizumab","Participants receive pembrolizumab 200 mg by intravenous (IV) infusion every 3 weeks (Q3W) for up to 24 months","Biological","pembrolizumab","200 mg by IV infusion Q3W for up to 24 months","KEYTRUDAÂ® | MK-3475","Pembrolizumab","\n\n * Has a histologically confirmed diagnosis of unresectable stage III or metastatic melanoma not amenable to local therapy\n * Has testing for a BRAF mutation prior to study entry\n * Has measurable disease per RECIST 1.1 as assessed by the investigator/radiology\n * Has resolution of toxic effect(s) of the most recent prior chemotherapy to Grade 1 or less (except alopecia). If the participant received major surgery or radiation therapy of >30 Gray units, they must have recovered from the toxicity and/or complications from the intervention\n * Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 10 days of study start\n * Is not pregnant or breastfeeding\n * Female participants of child-bearing potential must be willing to use effective contraception starting with the screening visit through 120 days after the last dose of study therapy\n\n","\n\n * Has disease that is suitable for local therapy administered with curative intent\n * Has a history of interstitial lung disease\n * Has a positive pregnancy test within 72 hours before the first dose of study therapy\n * Has received prior therapy with an anti-Programmed Cell Death Protein 1 (PD-1), anti-Programmed Cell Death-Ligand 1 (PD-L1), anti-Programmed Cell Death-Ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137)\n * Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to study start\n * Has received prior radiotherapy within 2 weeks of start of study therapy\n * Has received a live vaccine within 30 days prior to the first dose of study therapy\n * Has received transfusion of blood products (including platelets or red blood cells) or administration of colony stimulating factors (including granulocyte colony stimulating factor [G-CSF], granulocyte macrophage colony stimulating factor [GMCSF] or recombinant erythropoietin) within 4 weeks prior to study start\n * Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study therapy\n * Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study therapy\n * Has a known additional malignancy that is progressing or has required active treatment within the past 3 years with the exception of basal cell and squamous cell carcinoma of the skin, transitional cell carcinoma of urothelial cancer, or carcinoma in situ (eg, breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy\n * Has known active CNS metastases and/or carcinomatous meningitis\n * Has severe hypersensitivity (â‰¥Grade 3) to pembrolizumab and/or any of its excipients\n * Has an active autoimmune disease that has required systemic treatment in past 2 years\n * Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis\n * Has an active infection requiring systemic therapy\n * Has a known history of human immunodeficiency virus (HIV) infection\n * Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection\n * Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator\n * Has known psychiatric or substance abuse disorders that would interfere with cooperating with the requirements of the study\n * Is pregnant or breastfeeding or expecting to conceive or father children starting with the screening visit through 120 days after the last dose of study therapy",{"$nulls":4},"Actual","2018-01-23","Actual","Anticipated","2021-12-13","Anticipated","2018-06-01","2018-01-18","2018-01-18","2018-06-07","No","Programmed Cell Death-1 (PD-1)\nPD1\nProgrammed Cell Death-Ligand 1 (PD-L1)\nProgrammed Cell Death-Ligand 2 (PD-L2)\nPDL1\nPDL2","Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"MK-3475-161","Merck Protocol Number","Mean Fraction of Cytotoxic T-lymphocytes (FCT) for Participants with Response versus Participants with Progression|Average Specific Cytotoxic T-lymphocyte Frequency Ratio (ASCTFR) for Participants with Response vs Participants with Progression|Change in Baseline of FCT for Participants With Response Versus Participants With Progression","FCT is defined as the fraction of CD8+ T-cells expressing a predefined single-cell RNA gene signature to the total tumor infiltrating CD8+T-cells isolated from tumor biopsies.|ASCTFR is defined as the arithmetic average of the log^10 ratio of the frequency of individual specific cytotoxic T-Cell Receptor (TCR) clones of on-treatment to pre-treatment.|The fold change from baseline in FCT. FCT is defined as the fraction of CD8+ T-cells expressing a predefined single-cell RNA gene signature to the total tumor infiltrating CD8+T-cells isolated from tumor biopsies.","Up to 24 months|Baseline and Month 24","Adverse Events (AEs)|Treatment Discontinuations due to AEs|Overall Response Rate (ORR) per Immune-related Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1|Progression-free Survival (PFS) per RECIST Version 1.1|Overall Survival (OS)|Neoepitope Burden|Antigenic Determinants of Highly-functional CD8 + T-cell Clones","Number of participants experiencing an AE defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered related to the study treatment.|Number of participants discontinuing study drug due to an AE.|ORR is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: â‰¥30% decrease in the sum of diameters of target lesions) per RECIST Version 1.1 as assessed by the investigator.|PFS is defined as the time from start of treatment to the first documented progressive disease (PD) or death due to any cause, whichever occurs first, per RECIST Version 1.1 as assessed by the investigator..|OS is defined as the time from the start of treatment to death due to any cause.|Neoepitope sequencing will be generated based on single cell RNA sequencing (scRNAseq), whole exome sequencing, and an epitope prediction algorithm to obtain neoepitope burden.|TCRs from CD8+ T-cell clones will be identified by scRNAseq and their killing function will be confirmed by TCR-transduced T-cells recognizing autologous tumor-derived cell lines.","Up to 27 months|Up to 24 months","Trialsites@merck.com","Toll Free Number","1-888-577-8839","Boston, Massachusetts, United States, 02114","Massachusetts","United States","Massachusetts General Hospital ( Site 0102)",{"$nulls":3},"Medical Director","2018-06-07","2020-05-25T16:38:10.777","2020-05-26T17:10:42.972","NCT03407170"]
["5ecbf473feab101b15530940","NCT03407170","2018-07-18","Merck","MRK","Recruiting","Immunologic Determinants of Response to Pembrolizumab (MK-3475) in Advanced Melanoma (MK-3475-161/KEYNOTE-161)","Pembrolizumab","PD-1 Inhibitor","No",null,"No",null,"Phase 2",1,60,"Anticipated","2018-06-28","2021-12-13",{"$nulls":5},"In this study, participants with advanced melanoma will be treated with pembrolizumab (MK-3475) and their tumors and blood will be analyzed for changes related to pembrolizumab therapy.",null,"An Open-Label, Phase II Study to Determine the Immunologic Correlates of Pembrolizumab-Mediated Tumor Regression in Subjects With Advanced Melanoma (KEYNOTE-161)","3475-161","Advanced Melanoma","Noma|Melanoma","Mouth Diseases|Oncology Solid Tumor","Ear, Nose and Throat|Oncology","Experimental","Pembrolizumab","Participants receive pembrolizumab 200 mg by intravenous (IV) infusion every 3 weeks (Q3W) for up to 24 months","Biological","pembrolizumab","200 mg by IV infusion Q3W for up to 24 months","KEYTRUDAÂ® | MK-3475","Pembrolizumab","\n\n * Has a histologically confirmed diagnosis of unresectable stage III or metastatic melanoma not amenable to local therapy\n * Has testing for a BRAF mutation prior to study entry\n * Has measurable disease per RECIST 1.1 as assessed by the investigator/radiology\n * Has resolution of toxic effect(s) of the most recent prior chemotherapy to Grade 1 or less (except alopecia). If the participant received major surgery or radiation therapy of >30 Gray units, they must have recovered from the toxicity and/or complications from the intervention\n * Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 10 days of study start\n * Is not pregnant or breastfeeding\n * Female participants of child-bearing potential must be willing to use effective contraception starting with the screening visit through 120 days after the last dose of study therapy\n\n","\n\n * Has disease that is suitable for local therapy administered with curative intent\n * Has a history of interstitial lung disease\n * Has a positive pregnancy test within 72 hours before the first dose of study therapy\n * Has received prior therapy with an anti-Programmed Cell Death Protein 1 (PD-1), anti-Programmed Cell Death-Ligand 1 (PD-L1), anti-Programmed Cell Death-Ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137)\n * Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to study start\n * Has received prior radiotherapy within 2 weeks of start of study therapy\n * Has received a live vaccine within 30 days prior to the first dose of study therapy\n * Has received transfusion of blood products (including platelets or red blood cells) or administration of colony stimulating factors (including granulocyte colony stimulating factor [G-CSF], granulocyte macrophage colony stimulating factor [GMCSF] or recombinant erythropoietin) within 4 weeks prior to study start\n * Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study therapy\n * Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study therapy\n * Has a known additional malignancy that is progressing or has required active treatment within the past 3 years with the exception of basal cell and squamous cell carcinoma of the skin, transitional cell carcinoma of urothelial cancer, or carcinoma in situ (eg, breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy\n * Has known active CNS metastases and/or carcinomatous meningitis\n * Has severe hypersensitivity (â‰¥Grade 3) to pembrolizumab and/or any of its excipients\n * Has an active autoimmune disease that has required systemic treatment in past 2 years\n * Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis\n * Has an active infection requiring systemic therapy\n * Has a known history of human immunodeficiency virus (HIV) infection\n * Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection\n * Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator\n * Has known psychiatric or substance abuse disorders that would interfere with cooperating with the requirements of the study\n * Is pregnant or breastfeeding or expecting to conceive or father children starting with the screening visit through 120 days after the last dose of study therapy",{"$nulls":4},"Actual","2018-01-23","Actual","Anticipated","2021-12-13","Anticipated","2018-07-01","2018-01-18","2018-01-18","2018-07-17","No","Programmed Cell Death-1 (PD-1)\nPD1\nProgrammed Cell Death-Ligand 1 (PD-L1)\nProgrammed Cell Death-Ligand 2 (PD-L2)\nPDL1\nPDL2","Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"MK-3475-161","Merck Protocol Number","Mean Fraction of Cytotoxic T-lymphocytes (FCT) for Participants with Response versus Participants with Progression|Average Specific Cytotoxic T-lymphocyte Frequency Ratio (ASCTFR) for Participants with Response vs Participants with Progression|Change in Baseline of FCT for Participants With Response Versus Participants With Progression","FCT is defined as the fraction of CD8+ T-cells expressing a predefined single-cell RNA gene signature to the total tumor infiltrating CD8+T-cells isolated from tumor biopsies.|ASCTFR is defined as the arithmetic average of the log^10 ratio of the frequency of individual specific cytotoxic T-Cell Receptor (TCR) clones of on-treatment to pre-treatment.|The fold change from baseline in FCT. FCT is defined as the fraction of CD8+ T-cells expressing a predefined single-cell RNA gene signature to the total tumor infiltrating CD8+T-cells isolated from tumor biopsies.","Up to 24 months|Baseline and Month 24","Adverse Events (AEs)|Treatment Discontinuations due to AEs|Overall Response Rate (ORR) per Immune-related Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1|Progression-free Survival (PFS) per RECIST Version 1.1|Overall Survival (OS)|Neoepitope Burden|Antigenic Determinants of Highly-functional CD8 + T-cell Clones","Number of participants experiencing an AE defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered related to the study treatment.|Number of participants discontinuing study drug due to an AE.|ORR is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: â‰¥30% decrease in the sum of diameters of target lesions) per RECIST Version 1.1 as assessed by the investigator.|PFS is defined as the time from start of treatment to the first documented progressive disease (PD) or death due to any cause, whichever occurs first, per RECIST Version 1.1 as assessed by the investigator..|OS is defined as the time from the start of treatment to death due to any cause.|Neoepitope sequencing will be generated based on single cell RNA sequencing (scRNAseq), whole exome sequencing, and an epitope prediction algorithm to obtain neoepitope burden.|TCRs from CD8+ T-cell clones will be identified by scRNAseq and their killing function will be confirmed by TCR-transduced T-cells recognizing autologous tumor-derived cell lines.","Up to 27 months|Up to 24 months","Trialsites@merck.com","Toll Free Number","1-888-577-8839","Boston, Massachusetts, United States, 02114","Massachusetts","United States","Massachusetts General Hospital ( Site 0102)",{"$nulls":3},"Medical Director","2018-07-17","2020-05-25T16:38:11.561","2020-05-26T17:10:42.972","NCT03407170"]
["5ecbf473fe30261b1a048310","NCT03407170","2019-10-21","Merck","MRK","Terminated","Immunologic Determinants of Response to Pembrolizumab (MK-3475) in Advanced Melanoma (MK-3475-161/KEYNOTE-161)","Pembrolizumab","PD-1 Inhibitor","No",null,"No",null,"Phase 2",1,1,"Actual","2018-06-28","2019-08-14",{"$nulls":5},"In this study, participants with advanced melanoma will be treated with pembrolizumab (MK-3475) and their tumors and blood will be analyzed for changes related to pembrolizumab therapy.",null,"An Open-Label, Phase II Study to Determine the Immunologic Correlates of Pembrolizumab-Mediated Tumor Regression in Subjects With Advanced Melanoma (KEYNOTE-161)","3475-161","Advanced Melanoma","Noma|Melanoma","Mouth Diseases|Oncology Solid Tumor","Ear, Nose and Throat|Oncology","Experimental","Pembrolizumab","Participants receive pembrolizumab 200 mg by intravenous (IV) infusion every 3 weeks (Q3W) for up to 24 months","Biological","pembrolizumab","200 mg by IV infusion Q3W for up to 24 months","KEYTRUDAÂ® | MK-3475","Pembrolizumab","\n\n * Has a histologically confirmed diagnosis of unresectable stage III or metastatic melanoma not amenable to local therapy\n * Has testing for a BRAF mutation prior to study entry\n * Has measurable disease per RECIST 1.1 as assessed by the investigator/radiology\n * Has resolution of toxic effect(s) of the most recent prior chemotherapy to Grade 1 or less (except alopecia). If the participant received major surgery or radiation therapy of >30 Gray units, they must have recovered from the toxicity and/or complications from the intervention\n * Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 10 days of study start\n * A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: is not a woman of childbearing potential (WOCBP) OR is a WOCBP and agrees to use a contraceptive method, consistent with local regulations regarding the methods of contraception for those participating in clinical studies, during the treatment period and for at least 120 days after the last dose of study treatment\n * A male participant is eligible to participate if he agrees not to donate sperm PLUS to be abstinent from heterosexual intercourse as their preferred and usual lifestyle OR agree to use contraception, consistent with local regulations regarding the methods of contraception for those participating in clinical studies, during the treatment period and for at least 120 days after the last dose of study treatment\n\n","\n\n * Has disease that is suitable for local therapy administered with curative intent\n * Has a history of interstitial lung disease\n * Has a positive pregnancy test within 72 hours before the first dose of study therapy\n * Has received prior therapy with an anti-Programmed Cell Death Protein 1 (PD-1), anti-Programmed Cell Death-Ligand 1 (PD-L1), anti-Programmed Cell Death-Ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137)\n * Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to study start\n * Has received prior radiotherapy within 2 weeks of start of study therapy\n * Has received a live vaccine within 30 days prior to the first dose of study therapy\n * Has received transfusion of blood products (including platelets or red blood cells) or administration of colony stimulating factors (including granulocyte colony stimulating factor [G-CSF], granulocyte macrophage colony stimulating factor [GMCSF] or recombinant erythropoietin) within 4 weeks prior to study start\n * Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study therapy\n * Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study therapy\n * Has a known additional malignancy that is progressing or has required active treatment within the past 3 years with the exception of basal cell and squamous cell carcinoma of the skin, transitional cell carcinoma of urothelial cancer, or carcinoma in situ (eg, breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy\n * Has known active CNS metastases and/or carcinomatous meningitis\n * Has severe hypersensitivity (â‰¥Grade 3) to pembrolizumab and/or any of its excipients\n * Has an active autoimmune disease that has required systemic treatment in past 2 years\n * Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis\n * Has an active infection requiring systemic therapy\n * Has a known history of human immunodeficiency virus (HIV) infection\n * Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection\n * Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator\n * Has known psychiatric or substance abuse disorders that would interfere with cooperating with the requirements of the study\n * Is pregnant or breastfeeding or expecting to conceive or father children starting with the screening visit through 120 days after the last dose of study therapy",{"$nulls":4},"Actual","2018-01-23","Actual","Actual","2019-08-14","Actual","2019-10-01","2018-01-18","2018-01-18","2019-10-17","No","Programmed Cell Death-1 (PD-1)\nPD1\nProgrammed Cell Death-Ligand 1 (PD-L1)\nProgrammed Cell Death-Ligand 2 (PD-L2)\nPDL1\nPDL2","Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No","Yes\nhttp://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf",{"$nulls":3},"Yes","No",{"$nulls":17},"MK-3475-161","Merck Protocol Number","Mean Fraction of Cytotoxic T-lymphocytes (FCT) for Participants with Response versus Participants with Progression|Average Specific Cytotoxic T-lymphocyte Frequency Ratio (ASCTFR) for Participants with Response vs Participants with Progression|Change in Baseline of FCT for Participants With Response Versus Participants With Progression","FCT is defined as the fraction of CD8+ T-cells expressing a predefined single-cell RNA gene signature to the total tumor infiltrating CD8+T-cells isolated from tumor biopsies.|ASCTFR is defined as the arithmetic average of the log^10 ratio of the frequency of individual specific cytotoxic T-Cell Receptor (TCR) clones of on-treatment to pre-treatment.|The fold change from baseline in FCT. FCT is defined as the fraction of CD8+ T-cells expressing a predefined single-cell RNA gene signature to the total tumor infiltrating CD8+T-cells isolated from tumor biopsies.","Up to 24 months|Baseline and Month 24","Adverse Events (AEs)|Treatment Discontinuations due to AEs|Overall Response Rate (ORR) per Immune-related Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1|Progression-free Survival (PFS) per RECIST Version 1.1|Overall Survival (OS)|Neoepitope Burden|Antigenic Determinants of Highly-functional CD8 + T-cell Clones","Number of participants experiencing an AE defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered related to the study treatment.|Number of participants discontinuing study drug due to an AE.|ORR is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: â‰¥30% decrease in the sum of diameters of target lesions) per RECIST Version 1.1 as assessed by the investigator.|PFS is defined as the time from start of treatment to the first documented progressive disease (PD) or death due to any cause, whichever occurs first, per RECIST Version 1.1 as assessed by the investigator..|OS is defined as the time from the start of treatment to death due to any cause.|Neoepitope sequencing will be generated based on single cell RNA sequencing (scRNAseq), whole exome sequencing, and an epitope prediction algorithm to obtain neoepitope burden.|TCRs from CD8+ T-cell clones will be identified by scRNAseq and their killing function will be confirmed by TCR-transduced T-cells recognizing autologous tumor-derived cell lines.","Up to 27 months|Up to 24 months",{"$nulls":3},"Boston, Massachusetts, United States, 02114 Dana Farber Cancer Institute ( Site 0101)Boston, Massachusetts, United States, 02215","Massachusetts","United States","Massachusetts General Hospital ( Site 0102)",{"$nulls":3},"Medical Director","2019-10-17","2020-05-25T16:38:11.064","2020-05-26T17:10:42.972","NCT03407170"]
["5ecbf474feab101b15530941","NCT03407482","2018-02-28","Genentech","DNA","Recruiting","An Extension Study of GDC-0853 in Participants With Moderate to Severe Active Systemic Lupus Erythematosus","Fenebrutinib","Btk Inhibitor","Yes","['Fenebrutinib']","No",null,"Phase 2",1,240,"Anticipated","2018-01-11","2020-04-09",{"$nulls":5},"This Phase II, multicenter, open-label extension (OLE) study will evaluate the long-term safety and efficacy of GDC-0853 in participants with systemic lupus erythematosus (SLE) who have completed Study GA30044 (NCT02908100) up to 48 weeks.",null,"A Phase II, Open-Label Extension Study of Patients Previously Enrolled in Study GA30044 to Evaluate the Long-Term Safety and Efficacy of GDC-0853 in Patients With Moderate to Severe Active Systemic Lupus Erythematosus","GA30066","Lupus Erythematosus, Systemic","Lupus Erythematosus|Lupus Erythematosus, Systemic|Erythema","Connective Tissue Diseases|Dermatological Diseases","Derm & Connective Tissue Disorders","Experimental","GDC-0853","Participants will receive GDC-0853 twice daily (BID) for 48 weeks, followed by a safety follow-up period of 8 weeks.","Drug","GDC-0853","Participants will receive 4 tablets of GDC-0853 orally BID.",null,"GDC-0853","\n\n * Able to comply with the study protocol, in the investigator's judgment\n * Completion of Study GA30044 up to 48 weeks\n * Acceptable safety and tolerability during Study GA30044 as determined by the investigator\n\n","\n\n * Met protocol-defined treatment-stopping criteria during Study GA30044\n * An adverse event in Study GA30044 that required permanent discontinuation of study drug\n * In the opinion of the investigator, any new, significant, uncontrolled comorbidity or new clinical manifestation (related to SLE or not) that requires medications not allowed in this protocol; or could put the participant at undue risk from a safety perspective\n * Any uncontrolled or clinically significant laboratory abnormality that would affect safety, interpretation of study data, or the participant's participation in the study in the opinion of the investigator in consultation with the Medical Monitor",{"$nulls":4},"Actual","2018-01-23","Actual","Anticipated","2020-04-09","Anticipated","2018-02-01","2018-01-15","2018-01-15","2018-02-27",null,null,"Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","18 Years","76 Years","All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"2017-001764-37","EudraCT Number","Percentage of Participants With Adverse Events (AEs)","From first dose of study drug until 8 weeks after last dose of study drug (up to 56 weeks)",null,"Systemic Lupus Erythematosus Responder-4 Index (SRI-4) up to Week 48|Area Under the Concentration-Time Curve From Time 0 to Time t (AUC0-t) of GDC-0853|Steady-State Concentration (Ctrough) of GDC-0853|Plasma Half-Life (t1/2) of GDC-0853|Apparent Clearance (CL/F) of GDC-0853","Baseline up to Week 48|Pre-dose (0 hour|Pre-dose (0 hr) at Weeks 0, 24, 48, at unscheduled or flare or early termination visit (up to Week 56)","hr) at Weeks 0, 24, 48, at unscheduled or flare or early termination visit (up to Week 56)","global-roche-genentech-trials@gene.com","Reference Study ID Number: ML39356 www.roche.com/about_roche/roche_worldwide.htm","888-662-6728 (U.S. and Canada)","Buenos Aires, Argentina, B7600Fzn Organizacion Medica De InvestigacionBuenos Aires, Argentina, C1015Abo AprillusBuenos Aires, Argentina, C1194Aao Hospital ItalianoCaba, Argentina, C1199Abb Hospital General De Agudos Dr. J. M. Ramos MejiaCiudad Autonoma Buenos Aires, Argentina, C1221Adc Hospital Britanico De Buenos AiresCiudad Autonoma Buenos Aires, Argentina, C1284Aeb Clinica Adventista De Belgrano; CardiocirurgiaCiudad Autonoma Buenos Aires, Argentina, C1430Egf Sanatorio AllendeCordoba, Argentina, X5000Jhq Hospital Italiano De La PlataLa Plata, Argentina, 1725 Instituto De ReumatologiaMendoza, Argentina, 5500 Cer San Juan Centro Polivalente De Asistencia E Investigacion ClinicaSan Juan, Argentina, 5400 Centro MÃ©dico Privado De ReumatologÃ­aSan Miguel De Tucuman, Argentina, T4000Axl Investogaciones Clinicas TucumanTucuman, Argentina, 4000|Vitoria, Es, Brazil, 29055-450|Goiania, Go, Brazil, 74110-120|Belo Horizonte, Mg, Brazil, 31270-901 Centro De Onco-Hematologia De Mato GrossoCuiaba, Mg, Brazil, 78043-142 Centro Mineiro De Pesquisa - CmipJuiz De Fora, Mg, Brazil, 36036-330|Curitiba, Pr, Brazil, 80440-080|Rio De Janeiro, Rj, Brazil, 22649-900|Passo Fundo, Rs, Brazil, 99010-080 Hospital Moinhos De VentoPorto Alegre, Rs, Brazil, 90035-001 Centro De Pesquisas Em Diabetes - CpdPorto Alegre, Rs, Brazil, 90035-170|Itajai, Sc, Brazil, 88301-220|Santo Andre, Sp, Brazil, 09060-650 Centro Multidisciplinar De Estudos ClÃ­nicos - CemecSanto Andre, Sp, Brazil, 09190-510 Hospital Abreu SodrÃ© - AacdSao Paulo, Sp, Brazil, 04023-000 Cpclin - Centro De Pesquisas ClÃ­nicas Ltda.; Pesquisa ClinicaSÃ£o Paulo, Sp, Brazil, 01244-030|Pleven, Bulgaria, 5800 Mhat PlovdivPlovdiv, Bulgaria, 4003 Medical Center \"Teodora\", EoodRuse, Bulgaria, 7000 Medical Center Excelsior OodSofia, Bulgaria, 1000 Umhat \"Sv. Ivan Rilski\", EadSofia, Bulgaria, 1431 Umhat \"Sofiamed\", OodSofia, Bulgaria, 1750 Mc \"Synexus - Sofia\", EoodSofia, Bulgaria, 1784 Medical Center \"Nov Rehabilitatsionen Tsentar\", EoodStara Zagora, Bulgaria, 6000|Osorno, Chile, 5290000 Cecis SpaProvidencia, Chile DermacrossSantiago, Chile, 66901 Centro De Estudios ReumatologiSantiago, Chile, 7501126 SomealSantiago, Chile, 7510186 BiomedicaSantiago, Chile Cinvec - Centro De Investigacion Clinica V RegionViÃ±a Del Mar, Chile, 00000|Taichung, Taiwan, 40447 National Taiwan University HospitalTaipei, Taiwan, 10002 Tri-Service General HospitalTaipei, Taiwan, 11490 Chang Gung Memorial Hospital - LinkouTaoyuan, Taiwan, 333|Barranquilla, Colombia, 00000 Centro De Reumatologia Y OrtopediaBarranquilla, Colombia Servimed S.A.S.Bucaramanga, Colombia, 680003 Medicity S.A.S.Bucaramanga, Colombia Clinica De Artritis Temprana S.A.Cali, Colombia, 00000 Hospital Pablo Tobon UribeMedellin-Antioquia, Colombia|Berlin, Germany, 10117 Universitaetsklinikum KoelnKoeln, Germany, 50937 Korea, Republic Of Eulji University HospitalDaejeon, Korea, Republic Of, 35233 Ajou University HospitalGyeonggi-Do, Korea, Republic Of, 443-380 Seoul National University HospitalSeoul, Korea, Republic Of, 03080 Konkuk University Medical CenterSeoul, Korea, Republic Of, 05030 The Catholic University Of Korea St.Mary'S HospitalSeoul, Korea, Republic Of, 150-713|Torreon, Coahuila, Mexico, 27000|Cuernavaca, Mexico, 62290 Morales Vargas Centro De Investigacion S.C.Leon, Mexico, 37000 Inst. Nac. Salvador Zubiran, Mexico D.F., Mexico, 14000 Hospital Angeles Lindavista, Mexico, Mexico, 07760 Accelerium S. De R.L. De C.V.Monterrey, Mexico, 64000 Hospital Universitario De SaltilloSaltillo, Mexico, 25000 Hospital Central Dr. Ignacio Morones PrietoSan Luis Potosi S.L.P., Mexico, 78240|Guadalajara, Jalisco, Mexico, 44690|MÃ©rida, Yucatan, Mexico, 97000|Amadora-Lisbon, Portugal, 2610-276 Centro Hospitalar E UniversitÃ¡rio De Coimbra EpeCoimbra, Portugal, 3000-602 Instituto Portugues De ReumatologiaLisboa, Portugal, 1050-34 Centro Hospitalar De Lisboa Norte, Epe - Hospital Santa MariaLisboa, Portugal, 1649-035 Centro Hospitalar Do Porto - Hospital De Santo AntÃ³nioPorto, Portugal, 4099-001|Vitoria, Alava, Spain, 01004|A Coruna, La CoruÃ±a, Spain, 15006|MÃ¡laga, Malaga, Spain, 29009|El Palmar. Murcia, Murcia, Spain, 30120|Seville, Sevilla, Spain, 41071|Barcelona, Spain, 08035 Hospital General Universitario Gregorio MaraÃ±onMadrid, Spain, 28007 Hospital Clinico Universitario ValladolidValladolid, Spain, 47005 Taiwan Kaohsiung Chang Gung Memorial HospitalKaohsiung City, Taiwan, 00833 Kaohsiung Medical University Chung-Ho Memorial HospitalKaohsiung City, Taiwan, 807|Brighton, United Kingdom, Bn2 5Be Doncaster Royal Infirmary;ParentDoncaster, United Kingdom, Dn2 5Lt University College London HospitalLondon, United Kingdom, Nw1 - 2Pg Guy'S Hospital; Louise Coote Lupus UnitLondon, United Kingdom, Se1 9Rt Southampton General HospitalSouthampton, United Kingdom, So16 6Yd|Birmingham, Alabama, United States, 35294|Tucson, Arizona, United States, 85724|Beverly Hills, California, United States, 90211 Hcp Clinical Research, LlcHuntington Beach, California, United States, 92646 Valerius Medical GroupLos Alamitos, California, United States, 90720 Ucla David Geffen School Of MedicineTorrance, California, United States, 90505|Trumbull, Connecticut, United States, 06611|Boca Raton, Florida, United States, 33486 Bay Area Arthritis And OsteoporosisBrandon, Florida, United States, 33511 Clinical Research Of West FloridaClearwater, Florida, United States, 33765 Omega Researchconsultants LlcOrlando, Florida, United States, 32804 Clinical Research Of West FloridaTampa, Florida, United States, 33603|Idaho Falls, Idaho, United States, 83404|Fairway, Kansas, United States, 66205 Via Christi Research, A Division Of Via Christi Hospitals Wichita, Inc.Wichita, Kansas, United States, 67208|Baton Rouge, Louisiana, United States, 70809|Boston, Massachusetts, United States, 02118|Albuquerque, New|Canton, New York, United States, 13617 The Feinstein Institute For Medical Research; The Litwin-Zucker Research CenterManhasset, New York, United States, 11031 New York University School Of MedicineNew York, New York, United States, 10016|Chapel Hill, North Carolina, United States, 27599 Shanahan Rheumatology & Immunology, PllcRaleigh, North Carolina, United States, 27617|Cincinnati, Ohio, United States, 45219 Ohio State University Clinical Trials Management OfficeColumbus, Ohio, United States, 43210|Austin, Texas, United States, 78745 Rheumatic Disease Clin Res CtrHouston, Texas, United States, 77004 Accurate Clinical ResearchHouston, Texas, United States, 77058-3675 Accurate Clinical ResearchHouston, Texas, United States, 77058-3675 Accurate Clinical ResearchHouston, Texas, United States, 77089 Accurate Clinical ResearchHouston, Texas, United States, 77089 Arthritis Clinic Of Central TexasSan Marcos, Texas, United States, 78666","Alabama|Arizona|California|Connecticut|Florida|Idaho|Kansas|Louisiana|Massachusetts|New Mexico|New York|North Carolina|Ohio|Texas","Argentina|Brazil|Bulgaria|Chile|China|Colombia|Germany|Mexico|Portugal|Spain|United Kingdom|United States","Instituto De Investigaciones Clinicas-Mar Del Plata|Es Cedoes - DiagnÃ³stico E Pesquisa|Go Cip - Centro Internacional De Pesquisa|Mg Hospital Das Clinicas - Ufmg|Pr Edumed - EducaÃ§Ã£o E SaÃºde Sa|Rj ClÃ­nica De Reumatologia Do Centro MÃ©dico Barrashopping|Rs Hospital Sao Vicente De Paulo|Sc Clinica De Neoplasias Litoral|Sp Faculdade De Medicina Do Abc - Fmabc|Mhat \"Sv. Pantaleymon - Pleven\", Ood; Department Of Neurology|Corporacion De Beneficencia Osorno|Medical University Hospital|Fundacion Cardiomet, Armenia, Colombia| Centro Integral De Reumatologia Del Caribe Sas Circaribe Sas|CharitÃ© Research Organisation Gmbh|Coahuila Centro De Investigacion Alberto Bazzoni S.A. De C.V.|Consultorio Particular Del Dr. Miguel Cortes Hernandez|Jalisco Centro De Estudios De Investigacion Basica Y Clinica Sc|Yucatan Unidad De Atencion Medica E Investigacion En Salud S.C.|Hospital Professor Doutor Fernando Fonseca, E.P.E.|Alava Hospital Universitario Araba|La CoruÃ±a Complejo Hospitalario Universitario A CoruÃ±a|Malaga Hospital Regional Universitario De Malaga; Servicio De Reumatologia|Murcia Hospital Universitario Virgen De Arrixaca|Sevilla Hospital Universitario Virgen Macarena; Servicio De Anatomia Patologica|Vall D'Hebron Institut De Recerca-Vhir|Royal Sussex County Hospital|University Of Alabama At Birmingham|University Of Arizona Arthritis Center|Wallace Rheumatic Study Center|New England Research Associates|Rasf-Clinical Research Center|Institute Of Arthritis Research|University Of Kansas Medical Center Research Institute, Inc.; Phase 1|Ochsner Clinic Foundation|Boston University Medical Center|Albuquerque Clinical Trials|Saint Lawrence Health System|University Of North Carolina At Chapel Hill|Cincinnati Rheumatic Disease Study Group|Tekton Research Inc",{"$nulls":3},"Clinical Trials","2018-02-27","2020-05-25T16:38:12.672","2020-05-26T17:10:42.972","NCT03407482"]
["5ecbf474feab101b15530943","NCT03407482","2018-04-10","Genentech","DNA","Recruiting","An Extension Study of GDC-0853 in Participants With Moderate to Severe Active Systemic Lupus Erythematosus","Fenebrutinib","Btk Inhibitor","Yes","['Fenebrutinib']","No",null,"Phase 2",1,240,"Anticipated","2018-01-11","2020-04-09",{"$nulls":5},"This Phase II, multicenter, open-label extension (OLE) study will evaluate the long-term safety and efficacy of GDC-0853 in participants with systemic lupus erythematosus (SLE) who have completed Study GA30044 (NCT02908100) up to 48 weeks.",null,"A Phase II, Open-Label Extension Study of Patients Previously Enrolled in Study GA30044 to Evaluate the Long-Term Safety and Efficacy of GDC-0853 in Patients With Moderate to Severe Active Systemic Lupus Erythematosus","GA30066","Lupus Erythematosus, Systemic","Lupus Erythematosus|Lupus Erythematosus, Systemic|Erythema","Connective Tissue Diseases|Dermatological Diseases","Derm & Connective Tissue Disorders","Experimental","GDC-0853","Participants will receive GDC-0853 twice daily (BID) for 48 weeks, followed by a safety follow-up period of 8 weeks.","Drug","GDC-0853","Participants will receive 4 tablets of GDC-0853 orally BID.",null,"GDC-0853","\n\n * Able to comply with the study protocol, in the investigator's judgment\n * Completion of Study GA30044 up to 48 weeks\n * Acceptable safety and tolerability during Study GA30044 as determined by the investigator\n\n","\n\n * Met protocol-defined treatment-stopping criteria during Study GA30044\n * An adverse event in Study GA30044 that required permanent discontinuation of study drug\n * In the opinion of the investigator, any new, significant, uncontrolled comorbidity or new clinical manifestation (related to SLE or not) that requires medications not allowed in this protocol; or could put the participant at undue risk from a safety perspective\n * Any uncontrolled or clinically significant laboratory abnormality that would affect safety, interpretation of study data, or the participant's participation in the study in the opinion of the investigator in consultation with the Medical Monitor",{"$nulls":4},"Actual","2018-01-23","Actual","Anticipated","2020-04-09","Anticipated","2018-04-01","2018-01-15","2018-01-15","2018-04-09",null,null,"Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","18 Years","76 Years","All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"2017-001764-37","EudraCT Number","Percentage of Participants With Adverse Events (AEs)","From first dose of study drug until 8 weeks after last dose of study drug (up to 56 weeks)",null,"Systemic Lupus Erythematosus Responder-4 Index (SRI-4) up to Week 48|Area Under the Concentration-Time Curve From Time 0 to Time t (AUC0-t) of GDC-0853|Steady-State Concentration (Ctrough) of GDC-0853|Plasma Half-Life (t1/2) of GDC-0853|Apparent Clearance (CL/F) of GDC-0853","Baseline up to Week 48|Pre-dose (0 hour|Pre-dose (0 hr) at Weeks 0, 24, 48, at unscheduled or flare or early termination visit (up to Week 56)","hr) at Weeks 0, 24, 48, at unscheduled or flare or early termination visit (up to Week 56)","global-roche-genentech-trials@gene.com","Reference Study ID Number: GA30066 www.roche.com/about_roche/roche_worldwide.htm","888-662-6728 (U.S. and Canada)","Buenos Aires, Argentina, B7600Fzn Organizacion Medica De InvestigacionBuenos Aires, Argentina, C1015Abo AprillusBuenos Aires, Argentina, C1194Aao Hospital ItalianoCaba, Argentina, C1199Abb Hospital General De Agudos Dr. J. M. Ramos MejiaCiudad Autonoma Buenos Aires, Argentina, C1221Adc Hospital Britanico De Buenos AiresCiudad Autonoma Buenos Aires, Argentina, C1284Aeb Clinica Adventista De Belgrano; CardiocirurgiaCiudad Autonoma Buenos Aires, Argentina, C1430Egf Sanatorio AllendeCordoba, Argentina, X5000Jhq Hospital Italiano De La PlataLa Plata, Argentina, 1725 Instituto De ReumatologiaMendoza, Argentina, 5500 Cer San Juan Centro Polivalente De Asistencia E Investigacion ClinicaSan Juan, Argentina, 5400 Centro MÃ©dico Privado De ReumatologÃ­aSan Miguel De Tucuman, Argentina, T4000Axl Investogaciones Clinicas TucumanTucuman, Argentina, 4000|Vitoria, Es, Brazil, 29055-450|Goiania, Go, Brazil, 74110-120|Belo Horizonte, Mg, Brazil, 31270-901 Centro De Onco-Hematologia De Mato GrossoCuiaba, Mg, Brazil, 78043-142 Centro Mineiro De Pesquisa - CmipJuiz De Fora, Mg, Brazil, 36036-330|Curitiba, Pr, Brazil, 80440-080|Rio De Janeiro, Rj, Brazil, 22649-900|Passo Fundo, Rs, Brazil, 99010-080 Hospital Moinhos De VentoPorto Alegre, Rs, Brazil, 90035-001 Centro De Pesquisas Em Diabetes - CpdPorto Alegre, Rs, Brazil, 90035-170|Itajai, Sc, Brazil, 88301-220|Santo Andre, Sp, Brazil, 09060-650 Centro Multidisciplinar De Estudos ClÃ­nicos - CemecSanto Andre, Sp, Brazil, 09190-510 Hospital Abreu SodrÃ© - AacdSao Paulo, Sp, Brazil, 04023-000 Cpclin - Centro De Pesquisas ClÃ­nicas Ltda.; Pesquisa ClinicaSÃ£o Paulo, Sp, Brazil, 01244-030|Pleven, Bulgaria, 5800 Mhat PlovdivPlovdiv, Bulgaria, 4003 Medical Center \"Teodora\", EoodRuse, Bulgaria, 7000 Medical Center Excelsior OodSofia, Bulgaria, 1000 Umhat \"Sv. Ivan Rilski\", EadSofia, Bulgaria, 1431 Umhat \"Sofiamed\", OodSofia, Bulgaria, 1750 Mc \"Synexus - Sofia\", EoodSofia, Bulgaria, 1784 Medical Center \"Nov Rehabilitatsionen Tsentar\", EoodStara Zagora, Bulgaria, 6000|Osorno, Chile, 5290000 Cecis SpaProvidencia, Chile DermacrossSantiago, Chile, 66901 Centro De Estudios ReumatologiSantiago, Chile, 7501126 SomealSantiago, Chile, 7510186 BiomedicaSantiago, Chile Cinvec - Centro De Investigacion Clinica V RegionViÃ±a Del Mar, Chile, 00000|Taichung, Taiwan, 40447 National Taiwan University HospitalTaipei, Taiwan, 10002 Tri-Service General HospitalTaipei, Taiwan, 11490 Chang Gung Memorial Hospital - LinkouTaoyuan, Taiwan, 333|Barranquilla, Colombia, 00000 Centro De Reumatologia Y OrtopediaBarranquilla, Colombia Servimed S.A.S.Bucaramanga, Colombia, 680003 Medicity S.A.S.Bucaramanga, Colombia Clinica De Artritis Temprana S.A.Cali, Colombia, 00000 Hospital Pablo Tobon UribeMedellin-Antioquia, Colombia|Berlin, Germany, 10117 Universitaetsklinikum KoelnKoeln, Germany, 50937 Korea, Republic Of Eulji University HospitalDaejeon, Korea, Republic Of, 35233 Ajou University HospitalGyeonggi-Do, Korea, Republic Of, 443-380 Seoul National University HospitalSeoul, Korea, Republic Of, 03080 Konkuk University Medical CenterSeoul, Korea, Republic Of, 05030 The Catholic University Of Korea St.Mary'S HospitalSeoul, Korea, Republic Of, 150-713|Torreon, Coahuila, Mexico, 27000|Cuernavaca, Mexico, 62290 Morales Vargas Centro De Investigacion S.C.Leon, Mexico, 37000 Inst. Nac. Salvador Zubiran, Mexico D.F., Mexico, 14000 Hospital Angeles Lindavista, Mexico, Mexico, 07760 Accelerium S. De R.L. De C.V.Monterrey, Mexico, 64000 Hospital Universitario De SaltilloSaltillo, Mexico, 25000 Hospital Central Dr. Ignacio Morones PrietoSan Luis Potosi S.L.P., Mexico, 78240|Guadalajara, Jalisco, Mexico, 44690|MÃ©rida, Yucatan, Mexico, 97000|Amadora-Lisbon, Portugal, 2610-276 Centro Hospitalar E UniversitÃ¡rio De Coimbra EpeCoimbra, Portugal, 3000-602 Instituto Portugues De ReumatologiaLisboa, Portugal, 1050-34 Centro Hospitalar De Lisboa Norte, Epe - Hospital Santa MariaLisboa, Portugal, 1649-035 Centro Hospitalar Do Porto - Hospital De Santo AntÃ³nioPorto, Portugal, 4099-001|Vitoria, Alava, Spain, 01004|A Coruna, La CoruÃ±a, Spain, 15006|MÃ¡laga, Malaga, Spain, 29009|El Palmar. Murcia, Murcia, Spain, 30120|Seville, Sevilla, Spain, 41071|Barcelona, Spain, 08035 Hospital General Universitario Gregorio MaraÃ±onMadrid, Spain, 28007 Hospital Clinico Universitario ValladolidValladolid, Spain, 47005 Taiwan Kaohsiung Chang Gung Memorial HospitalKaohsiung City, Taiwan, 00833 Kaohsiung Medical University Chung-Ho Memorial HospitalKaohsiung City, Taiwan, 807|Brighton, United Kingdom, Bn2 5Be Doncaster Royal Infirmary;ParentDoncaster, United Kingdom, Dn2 5Lt University College London HospitalLondon, United Kingdom, Nw1 - 2Pg Guy'S Hospital; Louise Coote Lupus UnitLondon, United Kingdom, Se1 9Rt Southampton General HospitalSouthampton, United Kingdom, So16 6Yd|Birmingham, Alabama, United States, 35294|Tucson, Arizona, United States, 85724|Beverly Hills, California, United States, 90211 Hcp Clinical Research, LlcHuntington Beach, California, United States, 92646 Valerius Medical GroupLos Alamitos, California, United States, 90720 Ucla David Geffen School Of MedicineTorrance, California, United States, 90505|Trumbull, Connecticut, United States, 06611|Boca Raton, Florida, United States, 33486 Bay Area Arthritis And OsteoporosisBrandon, Florida, United States, 33511 Clinical Research Of West FloridaClearwater, Florida, United States, 33765 Omega Researchconsultants LlcOrlando, Florida, United States, 32804 Clinical Research Of West FloridaTampa, Florida, United States, 33603|Idaho Falls, Idaho, United States, 83404|Fairway, Kansas, United States, 66205 Via Christi Research, A Division Of Via Christi Hospitals Wichita, Inc.Wichita, Kansas, United States, 67208|Baton Rouge, Louisiana, United States, 70809|Boston, Massachusetts, United States, 02118|Albuquerque, New|Canton, New York, United States, 13617 The Feinstein Institute For Medical Research; The Litwin-Zucker Research CenterManhasset, New York, United States, 11031 New York University School Of MedicineNew York, New York, United States, 10016|Chapel Hill, North Carolina, United States, 27599 Shanahan Rheumatology & Immunology, PllcRaleigh, North Carolina, United States, 27617|Cincinnati, Ohio, United States, 45219 Ohio State University Clinical Trials Management OfficeColumbus, Ohio, United States, 43210|Austin, Texas, United States, 78745 Rheumatic Disease Clin Res CtrHouston, Texas, United States, 77004 Accurate Clinical ResearchHouston, Texas, United States, 77058-3675 Accurate Clinical ResearchHouston, Texas, United States, 77058-3675 Accurate Clinical ResearchHouston, Texas, United States, 77089 Accurate Clinical ResearchHouston, Texas, United States, 77089 Arthritis Clinic Of Central TexasSan Marcos, Texas, United States, 78666","Alabama|Arizona|California|Connecticut|Florida|Idaho|Kansas|Louisiana|Massachusetts|New Mexico|New York|North Carolina|Ohio|Texas","Argentina|Brazil|Bulgaria|Chile|China|Colombia|Germany|Mexico|Portugal|Spain|United Kingdom|United States","Instituto De Investigaciones Clinicas-Mar Del Plata|Es Cedoes - DiagnÃ³stico E Pesquisa|Go Cip - Centro Internacional De Pesquisa|Mg Hospital Das Clinicas - Ufmg|Pr Edumed - EducaÃ§Ã£o E SaÃºde Sa|Rj ClÃ­nica De Reumatologia Do Centro MÃ©dico Barrashopping|Rs Hospital Sao Vicente De Paulo|Sc Clinica De Neoplasias Litoral|Sp Faculdade De Medicina Do Abc - Fmabc|Mhat \"Sv. Pantaleymon - Pleven\", Ood; Department Of Neurology|Corporacion De Beneficencia Osorno|Medical University Hospital|Fundacion Cardiomet, Armenia, Colombia| Centro Integral De Reumatologia Del Caribe Sas Circaribe Sas|CharitÃ© Research Organisation Gmbh|Coahuila Centro De Investigacion Alberto Bazzoni S.A. De C.V.|Consultorio Particular Del Dr. Miguel Cortes Hernandez|Jalisco Centro De Estudios De Investigacion Basica Y Clinica Sc|Yucatan Unidad De Atencion Medica E Investigacion En Salud S.C.|Hospital Professor Doutor Fernando Fonseca, E.P.E.|Alava Hospital Universitario Araba|La CoruÃ±a Complejo Hospitalario Universitario A CoruÃ±a|Malaga Hospital Regional Universitario De Malaga; Servicio De Reumatologia|Murcia Hospital Universitario Virgen De Arrixaca|Sevilla Hospital Universitario Virgen Macarena; Servicio De Anatomia Patologica|Vall D'Hebron Institut De Recerca-Vhir|Royal Sussex County Hospital|University Of Alabama At Birmingham|University Of Arizona Arthritis Center|Wallace Rheumatic Study Center|New England Research Associates|Rasf-Clinical Research Center|Institute Of Arthritis Research|University Of Kansas Medical Center Research Institute, Inc.; Phase 1|Ochsner Clinic Foundation|Boston University Medical Center|Albuquerque Clinical Trials|Saint Lawrence Health System|University Of North Carolina At Chapel Hill|Cincinnati Rheumatic Disease Study Group|Tekton Research Inc",{"$nulls":3},"Clinical Trials","2018-04-09","2020-05-25T16:38:12.890","2020-05-26T17:10:42.972","NCT03407482"]
["5ecbf475e2561b1b11905e0e","NCT03407482","2018-07-17","Genentech","DNA","Recruiting","An Extension Study of GDC-0853 in Participants With Moderate to Severe Active Systemic Lupus Erythematosus","Fenebrutinib","Btk Inhibitor","Yes","['Fenebrutinib']","No",null,"Phase 2",1,240,"Anticipated","2018-01-09","2020-04-09",{"$nulls":5},"This Phase II, multicenter, open-label extension (OLE) study will evaluate the long-term safety and efficacy of GDC-0853 in participants with systemic lupus erythematosus (SLE) who have completed Study GA30044 (NCT02908100) up to 48 weeks.",null,"A Phase II, Open-Label Extension Study of Patients Previously Enrolled in Study GA30044 to Evaluate the Long-Term Safety and Efficacy of GDC-0853 in Patients With Moderate to Severe Active Systemic Lupus Erythematosus","GA30066","Lupus Erythematosus, Systemic","Lupus Erythematosus|Lupus Erythematosus, Systemic|Erythema","Connective Tissue Diseases|Dermatological Diseases","Derm & Connective Tissue Disorders","Experimental","GDC-0853","Participants will receive GDC-0853 twice daily (BID) for 48 weeks, followed by a safety follow-up period of 8 weeks.","Drug","GDC-0853","Participants will receive 4 tablets of GDC-0853 orally BID.",null,"GDC-0853","\n\n * Able to comply with the study protocol, in the investigator's judgment\n * Completion of Study GA30044 up to 48 weeks\n * Acceptable safety and tolerability during Study GA30044 as determined by the investigator\n\n","\n\n * Met protocol-defined treatment-stopping criteria during Study GA30044\n * An adverse event in Study GA30044 that required permanent discontinuation of study drug\n * In the opinion of the investigator, any new, significant, uncontrolled comorbidity or new clinical manifestation (related to SLE or not) that requires medications not allowed in this protocol; or could put the participant at undue risk from a safety perspective\n * Any uncontrolled or clinically significant laboratory abnormality that would affect safety, interpretation of study data, or the participant's participation in the study in the opinion of the investigator in consultation with the Medical Monitor",{"$nulls":4},"Actual","2018-01-23","Actual","Anticipated","2020-04-09","Anticipated","2018-07-01","2018-01-15","2018-01-15","2018-07-16",null,null,"Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","18 Years","76 Years","All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"2017-001764-37","EudraCT Number","Percentage of Participants With Adverse Events (AEs)","From first dose of study drug until 8 weeks after last dose of study drug (up to 56 weeks)",null,"Systemic Lupus Erythematosus Responder-4 Index (SRI-4) up to Week 48|Area Under the Concentration-Time Curve From Time 0 to Time t (AUC0-t) of GDC-0853|Steady-State Concentration (Ctrough) of GDC-0853|Plasma Half-Life (t1/2) of GDC-0853|Apparent Clearance (CL/F) of GDC-0853","Baseline up to Week 48|Pre-dose (0 hour|Pre-dose (0 hr) at Weeks 0, 24, 48, at unscheduled or flare or early termination visit (up to Week 56)","hr) at Weeks 0, 24, 48, at unscheduled or flare or early termination visit (up to Week 56)","global-roche-genentech-trials@gene.com","Reference Study ID Number: GA30066 www.roche.com/about_roche/roche_worldwide.htm","888-662-6728 (U.S. and Canada)","Buenos Aires, Argentina, B7600Fzn Organizacion Medica De InvestigacionBuenos Aires, Argentina, C1015Abo AprillusBuenos Aires, Argentina, C1194Aao Hospital ItalianoCaba, Argentina, C1199Abb Hospital General De Agudos Dr. J. M. Ramos MejiaCiudad Autonoma Buenos Aires, Argentina, C1221Adc Hospital Britanico De Buenos AiresCiudad Autonoma Buenos Aires, Argentina, C1284Aeb Clinica Adventista De Belgrano; CardiocirurgiaCiudad Autonoma Buenos Aires, Argentina, C1430Egf Sanatorio AllendeCordoba, Argentina, X5000Jhq Hospital Italiano De La PlataLa Plata, Argentina, 1725 Instituto De ReumatologiaMendoza, Argentina, 5500 Cer San Juan Centro Polivalente De Asistencia E Investigacion ClinicaSan Juan, Argentina, 5400 Centro MÃ©dico Privado De ReumatologÃ­aSan Miguel De Tucuman, Argentina, T4000Axl Investogaciones Clinicas TucumanTucuman, Argentina, 4000|Vitoria, Es, Brazil, 29055-450|Goiania, Go, Brazil, 74110-120|Belo Horizonte, Mg, Brazil, 31270-901 Centro De Onco-Hematologia De Mato GrossoCuiaba, Mg, Brazil, 78043-142 Centro Mineiro De Pesquisa - CmipJuiz De Fora, Mg, Brazil, 36036-330|Curitiba, Pr, Brazil, 80440-080|Rio De Janeiro, Rj, Brazil, 22649-900|Passo Fundo, Rs, Brazil, 99010-080 Hospital Moinhos De VentoPorto Alegre, Rs, Brazil, 90035-001 Centro De Pesquisas Em Diabetes - CpdPorto Alegre, Rs, Brazil, 90035-170|Itajai, Sc, Brazil, 88301-220|Santo Andre, Sp, Brazil, 09060-650 Centro Multidisciplinar De Estudos ClÃ­nicos - CemecSanto Andre, Sp, Brazil, 09190-510 Hospital Abreu SodrÃ© - AacdSao Paulo, Sp, Brazil, 04023-000 Cpclin - Centro De Pesquisas ClÃ­nicas Ltda.; Pesquisa ClinicaSÃ£o Paulo, Sp, Brazil, 01244-030|Pleven, Bulgaria, 5800 Mhat PlovdivPlovdiv, Bulgaria, 4003 Medical Center \"Teodora\", Eood[Active, Not Recruiting]Ruse, Bulgaria, 7000 Medical Center Excelsior OodSofia, Bulgaria, 1000 Umhat \"Sv. Ivan Rilski\", EadSofia, Bulgaria, 1431 Umhat \"Sofiamed\", OodSofia, Bulgaria, 1750 Mc \"Synexus - Sofia\", EoodSofia, Bulgaria, 1784 Medical Center \"Nov Rehabilitatsionen Tsentar\", Eood[Active, Not Recruiting]Stara Zagora, Bulgaria, 6000|Osorno, Chile, 5290000 Cecis SpaProvidencia, Chile DermacrossSantiago, Chile, 66901 Centro De Estudios ReumatologiSantiago, Chile, 7501126 SomealSantiago, Chile, 7510186 BiomedicaSantiago, Chile Cinvec - Centro De Investigacion Clinica V RegionViÃ±a Del Mar, Chile, 00000|Taichung, Taiwan, 40447 National Taiwan University HospitalTaipei, Taiwan, 10002 Tri-Service General HospitalTaipei, Taiwan, 11490 Chang Gung Memorial Hospital - LinkouTaoyuan, Taiwan, 333|Barranquilla, Colombia, 00000 Centro De Reumatologia Y OrtopediaBarranquilla, Colombia Servimed S.A.S.Bucaramanga, Colombia, 680003 Medicity S.A.S.Bucaramanga, Colombia Clinica De Artritis Temprana S.A.Cali, Colombia, 00000 Hospital Pablo Tobon UribeMedellin-Antioquia, Colombia|Berlin, Germany, 10117 Universitaetsklinikum KoelnKoeln, Germany, 50937 Korea, Republic Of Eulji University HospitalDaejeon, Korea, Republic Of, 35233 Ajou University HospitalGyeonggi-Do, Korea, Republic Of, 443-380 Seoul National University HospitalSeoul, Korea, Republic Of, 03080 Konkuk University Medical CenterSeoul, Korea, Republic Of, 05030 The Catholic University Of Korea St.Mary'S HospitalSeoul, Korea, Republic Of, 150-713|Torreon, Coahuila, Mexico, 27000|Cuernavaca, Mexico, 62290 Morales Vargas Centro De Investigacion S.C.Leon, Mexico, 37000 Inst. Nac. Salvador Zubiran, Mexico D.F., Mexico, 14000 Hospital Angeles Lindavista, Mexico, Mexico, 07760 Accelerium S. De R.L. De C.V.Monterrey, Mexico, 64000 Hospital Universitario De SaltilloSaltillo, Mexico, 25000 Hospital Central Dr. Ignacio Morones PrietoSan Luis Potosi S.L.P., Mexico, 78240|Guadalajara, Jalisco, Mexico, 44690|MÃ©rida, Yucatan, Mexico, 97000|Amadora-Lisbon, Portugal, 2610-276 Centro Hospitalar E UniversitÃ¡rio De Coimbra EpeCoimbra, Portugal, 3000-602 Instituto Portugues De ReumatologiaLisboa, Portugal, 1050-34 Centro Hospitalar De Lisboa Norte, Epe - Hospital Santa MariaLisboa, Portugal, 1649-035 Centro Hospitalar Do Porto - Hospital De Santo AntÃ³nioPorto, Portugal, 4099-001|Vitoria, Alava, Spain, 01004|A Coruna, La CoruÃ±a, Spain, 15006|MÃ¡laga, Malaga, Spain, 29009|El Palmar. Murcia, Murcia, Spain, 30120|Seville, Sevilla, Spain, 41071|Barcelona, Spain, 08035 Hospital General Universitario Gregorio MaraÃ±onMadrid, Spain, 28007 Hospital Clinico Universitario ValladolidValladolid, Spain, 47005 Taiwan Kaohsiung Chang Gung Memorial HospitalKaohsiung City, Taiwan, 00833 Kaohsiung Medical University Chung-Ho Memorial HospitalKaohsiung City, Taiwan, 807|Brighton, United Kingdom, Bn2 5Be Doncaster Royal Infirmary;ParentDoncaster, United Kingdom, Dn2 5Lt University College London HospitalLondon, United Kingdom, Nw1 - 2Pg Guy'S Hospital; Louise Coote Lupus UnitLondon, United Kingdom, Se1 9Rt Southampton General HospitalSouthampton, United Kingdom, So16 6Yd|Birmingham, Alabama, United States, 35294|Tucson, Arizona, United States, 85724|Beverly Hills, California, United States, 90211 Hcp Clinical Research, LlcHuntington Beach, California, United States, 92646 Valerius Medical GroupLos Alamitos, California, United States, 90720 Ucla David Geffen School Of MedicineTorrance, California, United States, 90505|Trumbull, Connecticut, United States, 06611|Boca Raton, Florida, United States, 33486 Bay Area Arthritis And OsteoporosisBrandon, Florida, United States, 33511 Clinical Research Of West FloridaClearwater, Florida, United States, 33765 Omega Researchconsultants LlcOrlando, Florida, United States, 32804 Clinical Research Of West FloridaTampa, Florida, United States, 33603|Idaho Falls, Idaho, United States, 83404|Fairway, Kansas, United States, 66205 Via Christi Research, A Division Of Via Christi Hospitals Wichita, Inc.Wichita, Kansas, United States, 67208|[Active, Not Recruiting]Baton Rouge, Louisiana, United States, 70809|Boston, Massachusetts, United States, 02118|Albuquerque, New|Canton, New York, United States, 13617 The Feinstein Institute For Medical Research; The Litwin-Zucker Research CenterManhasset, New York, United States, 11031 New York University School Of MedicineNew York, New York, United States, 10016|Chapel Hill, North Carolina, United States, 27599 Shanahan Rheumatology & Immunology, PllcRaleigh, North Carolina, United States, 27617|Cincinnati, Ohio, United States, 45219 Ohio State University Clinical Trials Management OfficeColumbus, Ohio, United States, 43210|Austin, Texas, United States, 78745 Rheumatic Disease Clin Res CtrHouston, Texas, United States, 77004 Accurate Clinical ResearchHouston, Texas, United States, 77058-3675 Accurate Clinical ResearchHouston, Texas, United States, 77058-3675 Accurate Clinical ResearchHouston, Texas, United States, 77089 Accurate Clinical ResearchHouston, Texas, United States, 77089 Arthritis Clinic Of Central TexasSan Marcos, Texas, United States, 78666","Alabama|Arizona|California|Connecticut|Florida|Idaho|Kansas|Louisiana|Massachusetts|New Mexico|New York|North Carolina|Ohio|Texas","Argentina|Brazil|Bulgaria|Chile|China|Colombia|Germany|Mexico|Portugal|Spain|United Kingdom|United States","Instituto De Investigaciones Clinicas-Mar Del Plata|Es Cedoes - DiagnÃ³stico E Pesquisa|Go Cip - Centro Internacional De Pesquisa|Mg Hospital Das Clinicas - Ufmg|Pr Edumed - EducaÃ§Ã£o E SaÃºde Sa|Rj ClÃ­nica De Reumatologia Do Centro MÃ©dico Barrashopping|Rs Hospital Sao Vicente De Paulo|Sc Clinica De Neoplasias Litoral|Sp Faculdade De Medicina Do Abc - Fmabc|Mhat \"Sv. Pantaleymon - Pleven\", Ood; Department Of Neurology|Corporacion De Beneficencia Osorno|Medical University Hospital|Fundacion Cardiomet, Armenia, Colombia| Centro Integral De Reumatologia Del Caribe Sas Circaribe Sas|CharitÃ© Research Organisation Gmbh|Coahuila Centro De Investigacion Alberto Bazzoni S.A. De C.V.|Consultorio Particular Del Dr. Miguel Cortes Hernandez|Jalisco Centro De Estudios De Investigacion Basica Y Clinica Sc|Yucatan Unidad De Atencion Medica E Investigacion En Salud S.C.|Hospital Professor Doutor Fernando Fonseca, E.P.E.|Alava Hospital Universitario Araba|La CoruÃ±a Complejo Hospitalario Universitario A CoruÃ±a|Malaga Hospital Regional Universitario De Malaga; Servicio De Reumatologia|Murcia Hospital Universitario Virgen De Arrixaca|Sevilla Hospital Universitario Virgen Macarena; Servicio De Anatomia Patologica|Vall D'Hebron Institut De Recerca-Vhir|Royal Sussex County Hospital|University Of Alabama At Birmingham|University Of Arizona Arthritis Center|Wallace Rheumatic Study Center|New England Research Associates|Rasf-Clinical Research Center|Institute Of Arthritis Research|University Of Kansas Medical Center Research Institute, Inc.; Phase 1|Ochsner Clinic Foundation|Boston University Medical Center|Albuquerque Clinical Trials|Saint Lawrence Health System|University Of North Carolina At Chapel Hill|Cincinnati Rheumatic Disease Study Group|Tekton Research Inc",{"$nulls":3},"Clinical Trials","2018-07-16","2020-05-25T16:38:13.094","2020-05-26T17:10:42.972","NCT03407482"]
["5ecbf475e2561b1b11905e0f","NCT03407482","2018-10-30","Genentech","DNA","Recruiting","An Extension Study of GDC-0853 in Participants With Moderate to Severe Active Systemic Lupus Erythematosus","Fenebrutinib","Btk Inhibitor","Yes","['Fenebrutinib']","No",null,"Phase 2",1,240,"Anticipated","2018-01-09","2020-04-09",{"$nulls":5},"This Phase II, multicenter, open-label extension (OLE) study will evaluate the long-term safety and efficacy of GDC-0853 in participants with systemic lupus erythematosus (SLE) who have completed Study GA30044 (NCT02908100) up to 48 weeks.",null,"A Phase II, Open-Label Extension Study of Patients Previously Enrolled in Study GA30044 to Evaluate the Long-Term Safety and Efficacy of GDC-0853 in Patients With Moderate to Severe Active Systemic Lupus Erythematosus","GA30066","Lupus Erythematosus, Systemic","Lupus Erythematosus|Lupus Erythematosus, Systemic|Erythema","Connective Tissue Diseases|Dermatological Diseases","Derm & Connective Tissue Disorders","Experimental","GDC-0853","Participants will receive GDC-0853 twice daily (BID) for 48 weeks, followed by a safety follow-up period of 8 weeks.","Drug","GDC-0853","Participants will receive 4 tablets of GDC-0853 orally BID.",null,"GDC-0853","\n\n * Able to comply with the study protocol, in the investigator's judgment\n * Completion of Study GA30044 up to 48 weeks\n * Acceptable safety and tolerability during Study GA30044 as determined by the investigator\n\n","\n\n * Met protocol-defined treatment-stopping criteria during Study GA30044\n * An adverse event in Study GA30044 that required permanent discontinuation of study drug\n * In the opinion of the investigator, any new, significant, uncontrolled comorbidity or new clinical manifestation (related to SLE or not) that requires medications not allowed in this protocol; or could put the participant at undue risk from a safety perspective\n * Any uncontrolled or clinically significant laboratory abnormality that would affect safety, interpretation of study data, or the participant's participation in the study in the opinion of the investigator in consultation with the Medical Monitor",{"$nulls":4},"Actual","2018-01-23","Actual","Anticipated","2020-04-09","Anticipated","2018-10-01","2018-01-15","2018-01-15","2018-10-29",null,null,"Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","18 Years","76 Years","All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"2017-001764-37","EudraCT Number","Percentage of Participants With Adverse Events (AEs)","From first dose of study drug until 8 weeks after last dose of study drug (up to 56 weeks)",null,"Systemic Lupus Erythematosus Responder-4 Index (SRI-4) up to Week 48|Area Under the Concentration-Time Curve From Time 0 to Time t (AUC0-t) of GDC-0853|Steady-State Concentration (Ctrough) of GDC-0853|Plasma Half-Life (t1/2) of GDC-0853|Apparent Clearance (CL/F) of GDC-0853","Baseline up to Week 48|Pre-dose (0 hour|Pre-dose (0 hr) at Weeks 0, 24, 48, at unscheduled or flare or early termination visit (up to Week 56)","hr) at Weeks 0, 24, 48, at unscheduled or flare or early termination visit (up to Week 56)","global-roche-genentech-trials@gene.com","Reference Study ID Number: GA30066 www.roche.com/about_roche/roche_worldwide.htm","888-662-6728 (U.S. and Canada)","Buenos Aires, Argentina, C1194Aao Hospital ItalianoCaba, Argentina, C1199Abb Hospital Britanico De Buenos AiresCiudad Autonoma Buenos Aires, Argentina, C1284Aeb Hospital Italiano De La PlataLa Plata, Argentina, 1725 Cer San Juan Centro Polivalente De Asistencia E Investigacion ClinicaSan Juan, Argentina, 5400 Centro MÃ©dico Privado De ReumatologÃ­aSan Miguel De Tucuman, Argentina, T4000Axl|Vitoria, Es, Brazil, 29055-450|Goiania, Go, Brazil, 74110-120|Belo Horizonte, Mg, Brazil, 31270-901 Centro De Onco-Hematologia De Mato GrossoCuiaba, Mg, Brazil, 78043-142 Centro Mineiro De Pesquisa - CmipJuiz De Fora, Mg, Brazil, 36036-330|Curitiba, Pr, Brazil, 80440-080|Rio De Janeiro, Rj, Brazil, 22649-900|Passo Fundo, Rs, Brazil, 99010-080 Hospital Moinhos De VentoPorto Alegre, Rs, Brazil, 90035-001 Centro De Pesquisas Em Diabetes - CpdPorto Alegre, Rs, Brazil, 90035-170|Itajai, Sc, Brazil, 88301-220|Santo Andre, Sp, Brazil, 09060-650 Centro Multidisciplinar De Estudos ClÃ­nicos - CemecSanto Andre, Sp, Brazil, 09190-510 Hospital Abreu SodrÃ© - AacdSao Paulo, Sp, Brazil, 04023-000 Cpclin - Centro De Pesquisas ClÃ­nicas Ltda.; Pesquisa ClinicaSÃ£o Paulo, Sp, Brazil, 01244-030|Pleven, Bulgaria, 5800 Mhat PlovdivPlovdiv, Bulgaria, 4003 Medical Center \"Teodora\", Eood[Active, Not Recruiting]Ruse, Bulgaria, 7000 Medical Center Excelsior OodSofia, Bulgaria, 1000 Umhat \"Sv. Ivan Rilski\", EadSofia, Bulgaria, 1431 Umhat \"Sofiamed\", OodSofia, Bulgaria, 1750 Mc \"Synexus - Sofia\", EoodSofia, Bulgaria, 1784 Medical Center \"Nov Rehabilitatsionen Tsentar\", Eood[Active, Not Recruiting]Stara Zagora, Bulgaria, 6000|Osorno, Chile, 5290000 Cecis SpaProvidencia, Chile DermacrossSantiago, Chile, 66901 Centro De Estudios ReumatologiSantiago, Chile, 7501126 SomealSantiago, Chile, 7510186 BiomedicaSantiago, Chile Cinvec - Centro De Investigacion Clinica V RegionViÃ±a Del Mar, Chile, 00000|Barranquilla, Colombia, 00000 Centro De Investigacion Medico Asistencial S.A.SBarranquilla, Colombia, 80020 Servimed S.A.S.Bucaramanga, Colombia, 680003 Medicity S.A.S.Bucaramanga, Colombia Clinica De Artritis Temprana S.A.Cali, Colombia, 00000 Hospital Pablo Tobon UribeMedellin-Antioquia, Colombia|Berlin, Germany, 10117 Korea, Republic Of Eulji University HospitalDaejeon, Korea, Republic Of, 35233 Ajou University HospitalGyeonggi-Do, Korea, Republic Of, 443-380 Konkuk University Medical CenterSeoul, Korea, Republic Of, 05030 The Catholic University Of Korea St.Mary'S HospitalSeoul, Korea, Republic Of, 150-713|Torreon, Coahuila, Mexico, 27000|Cuernavaca, Mexico, 62290 Morales Vargas Centro De Investigacion S.C.Leon, Mexico, 37000 Inst. Nac. Salvador Zubiran, Mexico D.F., Mexico, 14000 Hospital Angeles Lindavista, Mexico, Mexico, 07760 Accelerium S. De R.L. De C.V.Monterrey, Mexico, 64000 Hospital Universitario De SaltilloSaltillo, Mexico, 25000 Hospital Central Dr. Ignacio Morones PrietoSan Luis Potosi S.L.P., Mexico, 78240|Guadalajara, Jalisco, Mexico, 44690|MÃ©rida, Yucatan, Mexico, 97000|Amadora-Lisbon, Portugal, 2610-276 Centro Hospitalar E UniversitÃ¡rio De Coimbra EpeCoimbra, Portugal, 3000-602 Instituto Portugues De ReumatologiaLisboa, Portugal, 1050-34 Centro Hospitalar De Lisboa Norte, Epe - Hospital Santa MariaLisboa, Portugal, 1649-035 Centro Hospitalar Do Porto - Hospital De Santo AntÃ³nioPorto, Portugal, 4099-001|Vitoria, Alava, Spain, 01004|Barcelona, Spain, 08035 Hospital General Universitario Gregorio MaraÃ±onMadrid, Spain, 28007 Hospital Clinico Universitario ValladolidValladolid, Spain, 47005 Hospital Universitario Rio HortegaValladolid, Spain, 47012 Taiwan Kaohsiung Chang Gung Memorial HospitalKaohsiung City, Taiwan, 00833 National Taiwan University HospitalTaipei, Taiwan, 10002 Tri-Service General HospitalTaipei, Taiwan, 11490 Chang Gung Memorial Hospital - LinkouTaoyuan, Taiwan, 333|A Coruna, La CoruÃ±a, Spain, 15006|MÃ¡laga, Malaga, Spain, 29009|El Palmar. Murcia, Murcia, Spain, 30120|Seville, Sevilla, Spain, 41071|London, United Kingdom, Se1 9Rt|Birmingham, Alabama, United States, 35294|Tucson, Arizona, United States, 85724|Beverly Hills, California, United States, 90211 Hcp Clinical Research, LlcHuntington Beach, California, United States, 92646 Valerius Medical GroupLos Alamitos, California, United States, 90720 Ucla David Geffen School Of MedicineTorrance, California, United States, 90505|Trumbull, Connecticut, United States, 06611|[Active, Not Recruiting]Boca Raton, Florida, United States, 33486 Bay Area Arthritis And OsteoporosisBrandon, Florida, United States, 33511 Clinical Research Of West FloridaClearwater, Florida, United States, 33765 Omega Researchconsultants LlcOrlando, Florida, United States, 32804 Clinical Research Of West FloridaTampa, Florida, United States, 33603|Idaho Falls, Idaho, United States, 83404|Fairway, Kansas, United States, 66205 Via Christi Research, A Division Of Via Christi Hospitals Wichita, Inc.Wichita, Kansas, United States, 67208|[Active, Not Recruiting]Baton Rouge, Louisiana, United States, 70809|Boston, Massachusetts, United States, 02118|Albuquerque, New|Canton, New York, United States, 13617 The Feinstein Institute For Medical Research; The Litwin-Zucker Research CenterManhasset, New York, United States, 11031 New York University School Of MedicineNew York, New York, United States, 10016|Chapel Hill, North Carolina, United States, 27599 Shanahan Rheumatology & Immunology, PllcRaleigh, North Carolina, United States, 27617|Cincinnati, Ohio, United States, 45219 Ohio State University Clinical Trials Management OfficeColumbus, Ohio, United States, 43210|Austin, Texas, United States, 78745 Rheumatic Disease Clin Res CtrHouston, Texas, United States, 77004 Accurate Clinical ResearchHouston, Texas, United States, 77058-3675 Accurate Clinical ResearchHouston, Texas, United States, 77058-3675 Accurate Clinical ResearchHouston, Texas, United States, 77089 Accurate Clinical ResearchHouston, Texas, United States, 77089 Arthritis Clinic Of Central TexasSan Marcos, Texas, United States, 78666","Alabama|Arizona|California|Connecticut|Florida|Idaho|Kansas|Louisiana|Massachusetts|New Mexico|New York|North Carolina|Ohio|Texas","Argentina|Brazil|Bulgaria|Chile|Colombia|Germany|Mexico|Portugal|Spain|United Kingdom|United States","Aprillus|Es Cedoes - DiagnÃ³stico E Pesquisa|Go Cip - Centro Internacional De Pesquisa|Mg Hospital Das Clinicas - Ufmg|Pr Edumed - EducaÃ§Ã£o E SaÃºde Sa|Rj ClÃ­nica De Reumatologia Do Centro MÃ©dico Barrashopping|Rs Hospital Sao Vicente De Paulo|Sc Clinica De Neoplasias Litoral|Sp Faculdade De Medicina Do Abc - Fmabc|Mhat \"Sv. Pantaleymon - Pleven\", Ood; Department Of Neurology|Corporacion De Beneficencia Osorno|Fundacion Cardiomet, Armenia, Colombia| Centro Integral De Reumatologia Del Caribe Sas Circaribe Sas|CharitÃ© Research Organisation Gmbh|Coahuila Centro De Investigacion Alberto Bazzoni S.A. De C.V.|Consultorio Particular Del Dr. Miguel Cortes Hernandez|Jalisco Centro De Estudios De Investigacion Basica Y Clinica Sc|Yucatan Unidad De Atencion Medica E Investigacion En Salud S.C.|Hospital Professor Doutor Fernando Fonseca, E.P.E.|Alava Hospital Universitario Araba|Hospital Universitari Vall D'Hebron|La CoruÃ±a FundaciÃ³n Profesor Novoa Santos|Malaga Hospital Regional Universitario De Malaga; Servicio De Reumatologia|Murcia Hospital Universitario Virgen De Arrixaca|Sevilla Hospital Universitario Virgen Macarena; Servicio De Anatomia Patologica|Guy's Hospital; Louise Coote Lupus Unit|University Of Alabama At Birmingham|University Of Arizona Arthritis Center|Wallace Rheumatic Study Center|New England Research Associates|Rasf-Clinical Research Center|Institute Of Arthritis Research|University Of Kansas Medical Center Research Institute, Inc.; Phase 1|Ochsner Clinic Foundation|Boston University Medical Center|Albuquerque Clinical Trials|Saint Lawrence Health System|University Of North Carolina At Chapel Hill|Cincinnati Rheumatic Disease Study Group|Tekton Research Inc",{"$nulls":3},"Clinical Trials","2018-10-29","2020-05-25T16:38:13.228","2020-05-26T17:10:42.972","NCT03407482"]
["5ecbf47511702c1b1b916b24","NCT03407482","2019-04-05","Genentech","DNA","Recruiting","An Extension Study of GDC-0853 in Participants With Moderate to Severe Active Systemic Lupus Erythematosus","Fenebrutinib","Btk Inhibitor","Yes","['Fenebrutinib']","No",null,"Phase 2",1,240,"Anticipated","2018-01-09","2020-04-09",{"$nulls":5},"This Phase II, multicenter, open-label extension (OLE) study will evaluate the long-term safety and efficacy of GDC-0853 in participants with systemic lupus erythematosus (SLE) who have completed Study GA30044 (NCT02908100) up to 48 weeks.",null,"A Phase II, Open-Label Extension Study of Patients Previously Enrolled in Study GA30044 to Evaluate the Long-Term Safety and Efficacy of GDC-0853 in Patients With Moderate to Severe Active Systemic Lupus Erythematosus","GA30066","Lupus Erythematosus, Systemic","Lupus Erythematosus|Lupus Erythematosus, Systemic|Erythema","Connective Tissue Diseases|Dermatological Diseases","Derm & Connective Tissue Disorders","Experimental","GDC-0853","Participants will receive GDC-0853 twice daily (BID) for 48 weeks, followed by a safety follow-up period of 8 weeks.","Drug","GDC-0853","Participants will receive 4 tablets of GDC-0853 orally BID.",null,"GDC-0853","\n\n * Able to comply with the study protocol, in the investigator's judgment\n * Completion of Study GA30044 up to 48 weeks\n * Acceptable safety and tolerability during Study GA30044 as determined by the investigator\n\n","\n\n * Met protocol-defined treatment-stopping criteria during Study GA30044\n * An adverse event in Study GA30044 that required permanent discontinuation of study drug\n * In the opinion of the investigator, any new, significant, uncontrolled comorbidity or new clinical manifestation (related to SLE or not) that requires medications not allowed in this protocol; or could put the participant at undue risk from a safety perspective\n * Any uncontrolled or clinically significant laboratory abnormality that would affect safety, interpretation of study data, or the participant's participation in the study in the opinion of the investigator in consultation with the Medical Monitor",{"$nulls":4},"Actual","2018-01-23","Actual","Anticipated","2020-04-09","Anticipated","2019-04-01","2018-01-15","2018-01-15","2019-04-04",null,null,"Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","18 Years","76 Years","All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"2017-001764-37","EudraCT Number","Percentage of Participants With Adverse Events (AEs)","From first dose of study drug until 8 weeks after last dose of study drug (up to 56 weeks)",null,"Systemic Lupus Erythematosus Responder-4 Index (SRI-4) up to Week 48|Area Under the Concentration-Time Curve From Time 0 to Time t (AUC0-t) of GDC-0853|Steady-State Concentration (Ctrough) of GDC-0853|Plasma Half-Life (t1/2) of GDC-0853|Apparent Clearance (CL/F) of GDC-0853","Baseline up to Week 48|Pre-dose (0 hour|Pre-dose (0 hr) at Weeks 0, 24, 48, at unscheduled or flare or early termination visit (up to Week 56)","hr) at Weeks 0, 24, 48, at unscheduled or flare or early termination visit (up to Week 56)","global-roche-genentech-trials@gene.com","Reference Study ID Number: GA30066 www.roche.com/about_roche/roche_worldwide.htm","888-662-6728 (U.S. and Canada)","Buenos Aires, Argentina, C1194Aao Hospital ItalianoCaba, Argentina, C1199Abb Hospital Britanico De Buenos AiresCiudad Autonoma Buenos Aires, Argentina, C1284Aeb Hospital Italiano De La PlataLa Plata, Argentina, 1725 Cer San Juan Centro Polivalente De Asistencia E Investigacion ClinicaSan Juan, Argentina, 5400 Centro MÃ©dico Privado De ReumatologÃ­a[Active, Not Recruiting]San Miguel De Tucuman, Argentina, T4000Axl|Vitoria, Es, Brazil, 29055-450|Goiania, Go, Brazil, 74110-120|Belo Horizonte, Mg, Brazil, 31270-901 Centro De Onco-Hematologia De Mato GrossoCuiaba, Mg, Brazil, 78043-142 Centro Mineiro De Pesquisa - CmipJuiz De Fora, Mg, Brazil, 36036-330|Curitiba, Pr, Brazil, 80440-080|Rio De Janeiro, Rj, Brazil, 22649-900|Passo Fundo, Rs, Brazil, 99010-080 Hospital Moinhos De VentoPorto Alegre, Rs, Brazil, 90035-001 Centro De Pesquisas Em Diabetes - CpdPorto Alegre, Rs, Brazil, 90035-170|Itajai, Sc, Brazil, 88301-220|[Active, Not Recruiting]Santo Andre, Sp, Brazil, 09060-650 Centro Multidisciplinar De Estudos ClÃ­nicos - CemecSanto Andre, Sp, Brazil, 09190-510 Hospital Abreu SodrÃ© - AacdSao Paulo, Sp, Brazil, 04023-000 Cpclin - Centro De Pesquisas ClÃ­nicas Ltda.; Pesquisa ClinicaSÃ£o Paulo, Sp, Brazil, 01244-030|Pleven, Bulgaria, 5800 Mhat PlovdivPlovdiv, Bulgaria, 4003 Medical Center \"Teodora\", Eood[Active, Not Recruiting]Ruse, Bulgaria, 7000 Medical Center Excelsior OodSofia, Bulgaria, 1000 Umhat \"Sv. Ivan Rilski\", EadSofia, Bulgaria, 1431 Umhat \"Sofiamed\", OodSofia, Bulgaria, 1750 Mc \"Synexus - Sofia\", Eood[Active, Not Recruiting]Sofia, Bulgaria, 1784 Medical Center \"Nov Rehabilitatsionen Tsentar\", Eood[Active, Not Recruiting]Stara Zagora, Bulgaria, 6000|Providencia, Chile, 7500571 DermacrossSantiago, Chile, 66901 Centro De Estudios ReumatologiSantiago, Chile, 7501126 SomealSantiago, Chile, 7510186 BiomedicaSantiago, Chile|Barranquilla, Colombia, 00000 Centro De Investigacion Medico Asistencial S.A.SBarranquilla, Colombia, 80020 Medicity S.A.S.[Active, Not Recruiting]Bucaramanga, Colombia, 680003 Servimed S.A.S.Bucaramanga, Colombia, 680003 Clinica De Artritis Temprana S.A.Cali, Colombia, 00000 Hospital Pablo Tobon UribeMedellin-Antioquia, Colombia|Berlin, Germany, 10117 Korea, Republic Of Eulji University HospitalDaejeon, Korea, Republic Of, 35233 Ajou University HospitalGyeonggi-Do, Korea, Republic Of, 443-380 Konkuk University Medical CenterSeoul, Korea, Republic Of, 05030 The Catholic University Of Korea St.Mary'S HospitalSeoul, Korea, Republic Of, 150-713|Torreon, Coahuila, Mexico, 27000|Cuernavaca, Mexico, 62290 Morales Vargas Centro De Investigacion S.C.Leon, Mexico, 37000 Inst. Nac. Salvador Zubiran, Mexico D.F., Mexico, 14000 Hospital Angeles Lindavista, Mexico, Mexico, 07760 Accelerium S. De R.L. De C.V.Monterrey, Mexico, 64000 Hospital Universitario De SaltilloSaltillo, Mexico, 25000 Hospital Central Dr. Ignacio Morones PrietoSan Luis Potosi S.L.P., Mexico, 78240|Guadalajara, Jalisco, Mexico, 44690|MÃ©rida, Yucatan, Mexico, 97000|Vitoria, Alava, Spain, 01004|[Active, Not Recruiting]Barcelona, Spain, 08035 Hospital General Universitario Gregorio MaraÃ±onMadrid, Spain, 28007 Hospital Clinico Universitario Valladolid[Active, Not Recruiting]Valladolid, Spain, 47005 Hospital Universitario Rio Hortega[Active, Not Recruiting]Valladolid, Spain, 47012 Taiwan Kaohsiung Chang Gung Memorial Hospital[Active, Not Recruiting]Kaohsiung City, Taiwan, 00833 National Taiwan University Hospital[Active, Not Recruiting]Taipei, Taiwan, 10002 Tri-Service General HospitalTaipei, Taiwan, 11490 Chang Gung Memorial Hospital - Linkou[Active, Not Recruiting]Taoyuan, Taiwan, 333|[Active, Not Recruiting]A Coruna, La CoruÃ±a, Spain, 15006|MÃ¡laga, Malaga, Spain, 29009|El Palmar. Murcia, Murcia, Spain, 30120|Seville, Sevilla, Spain, 41071|London, United Kingdom, Se1 9Rt|Tucson, Arizona, United States, 85724|Beverly Hills, California, United States, 90211 Hcp Clinical Research, LlcHuntington Beach, California, United States, 92646 Valerius Medical Group[Active, Not Recruiting]Los Alamitos, California, United States, 90720 Ucla David Geffen School Of MedicineTorrance, California, United States, 90505|Trumbull, Connecticut, United States, 06611|[Active, Not Recruiting]Boca Raton, Florida, United States, 33486 Bay Area Arthritis And OsteoporosisBrandon, Florida, United States, 33511 Clinical Research Of West FloridaClearwater, Florida, United States, 33765 Clinical Research Of West FloridaTampa, Florida, United States, 33603|[Active, Not Recruiting]Idaho Falls, Idaho, United States, 83404|Fairway, Kansas, United States, 66205 Via Christi Research, A Division Of Via Christi Hospitals Wichita, Inc.Wichita, Kansas, United States, 67208|[Active, Not Recruiting]Baton Rouge, Louisiana, United States, 70809|Boston, Massachusetts, United States, 02118|Albuquerque, New|Canton, New York, United States, 13617 The Feinstein Institute For Medical Research; The Litwin-Zucker Research CenterManhasset, New York, United States, 11031 New York University School Of MedicineNew York, New York, United States, 10016|Chapel Hill, North Carolina, United States, 27599 Shanahan Rheumatology & Immunology, PllcRaleigh, North Carolina, United States, 27617|Cincinnati, Ohio, United States, 45219 Ohio State University Clinical Trials Management OfficeColumbus, Ohio, United States, 43210|[Active, Not Recruiting]Austin, Texas, United States, 78745 Accurate Clinical ResearchHouston, Texas, United States, 77058-3675 Accurate Clinical ResearchHouston, Texas, United States, 77058-3675 Accurate Clinical ResearchHouston, Texas, United States, 77089 Accurate Clinical Research[Active, Not Recruiting]Houston, Texas, United States, 77089 Arthritis Clinic Of Central TexasSan Marcos, Texas, United States, 78666","Arizona|California|Connecticut|Florida|Idaho|Kansas|Louisiana|Massachusetts|New Mexico|New York|North Carolina|Ohio|Texas","Argentina|Brazil|Bulgaria|Chile|Colombia|Germany|Mexico|Spain|United Kingdom|United States","Aprillus|Es Cedoes - DiagnÃ³stico E Pesquisa|Go Cip - Centro Internacional De Pesquisa|Mg Hospital Das Clinicas - Ufmg|Pr Edumed - EducaÃ§Ã£o E SaÃºde Sa|Rj ClÃ­nica De Reumatologia Do Centro MÃ©dico Barrashopping|Rs Hospital Sao Vicente De Paulo|Sc Clinica De Neoplasias Litoral|Sp Faculdade De Medicina Do Abc - Fmabc|Mhat \"Sv. Pantaleymon - Pleven\", Ood; Department Of Neurology|Ctr Estudios Spa|Fundacion Cardiomet, Armenia, Colombia| Centro Integral De Reumatologia Del Caribe Sas Circaribe Sas|CharitÃ© Research Organisation Gmbh|Coahuila Centro De Investigacion Alberto Bazzoni S.A. De C.V.|Consultorio Particular Del Dr. Miguel Cortes Hernandez|Jalisco Centro De Estudios De Investigacion Basica Y Clinica Sc|Yucatan Unidad De Atencion Medica E Investigacion En Salud S.C.|Alava Hospital Universitario Araba|Hospital Universitari Vall D'Hebron|La CoruÃ±a FundaciÃ³n Profesor Novoa Santos|Malaga Hospital Regional Universitario De Malaga; Servicio De Reumatologia|Murcia Hospital Universitario Virgen De Arrixaca|Sevilla Hospital Universitario Virgen Macarena; Servicio De Anatomia Patologica|Guy's Hospital; Louise Coote Lupus Unit|University Of Arizona Arthritis Center|Wallace Rheumatic Study Center|New England Research Associates|Rasf-Clinical Research Center|Institute Of Arthritis Research|University Of Kansas Medical Center Research Institute, Inc.; Phase 1|Ochsner Clinic Foundation|Boston University Medical Center|Albuquerque Clinical Trials|Saint Lawrence Health System|University Of North Carolina At Chapel Hill|Cincinnati Rheumatic Disease Study Group|Tekton Research Inc",{"$nulls":3},"Clinical Trials","2019-04-04","2020-05-25T16:38:13.646","2020-05-26T17:10:42.972","NCT03407482"]
["5ecbf475fe30261b1a048315","NCT03407482","2019-10-10","Genentech","DNA","Active, not recruiting","An Extension Study of GDC-0853 in Participants With Moderate to Severe Active Systemic Lupus Erythematosus","Fenebrutinib","Btk Inhibitor","Yes","['Fenebrutinib']","No",null,"Phase 2",1,160,"Actual","2018-01-09","2020-04-10",{"$nulls":5},"This Phase II, multicenter, open-label extension (OLE) study will evaluate the long-term safety and efficacy of GDC-0853 in participants with systemic lupus erythematosus (SLE) who have completed Study GA30044 (NCT02908100) up to 48 weeks.",null,"A Phase II, Open-Label Extension Study of Patients Previously Enrolled in Study GA30044 to Evaluate the Long-Term Safety and Efficacy of GDC-0853 in Patients With Moderate to Severe Active Systemic Lupus Erythematosus","GA30066","Lupus Erythematosus, Systemic","Lupus Erythematosus|Lupus Erythematosus, Systemic|Erythema","Connective Tissue Diseases|Dermatological Diseases","Derm & Connective Tissue Disorders","Experimental","GDC-0853","Participants will receive GDC-0853 twice daily (BID) for 48 weeks, followed by a safety follow-up period of 8 weeks.","Drug","GDC-0853","Participants will receive 4 tablets of GDC-0853 orally BID.",null,"GDC-0853","\n\n * Able to comply with the study protocol, in the investigator's judgment\n * Completion of Study GA30044 up to 48 weeks\n * Acceptable safety and tolerability during Study GA30044 as determined by the investigator\n\n","\n\n * Met protocol-defined treatment-stopping criteria during Study GA30044\n * An adverse event in Study GA30044 that required permanent discontinuation of study drug\n * In the opinion of the investigator, any new, significant, uncontrolled comorbidity or new clinical manifestation (related to SLE or not) that requires medications not allowed in this protocol; or could put the participant at undue risk from a safety perspective\n * Any uncontrolled or clinically significant laboratory abnormality that would affect safety, interpretation of study data, or the participant's participation in the study in the opinion of the investigator in consultation with the Medical Monitor",{"$nulls":4},"Actual","2018-01-23","Actual","Anticipated","2020-04-10","Anticipated","2019-10-01","2018-01-15","2018-01-15","2019-10-08",null,null,"Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","18 Years","76 Years","All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"2017-001764-37","EudraCT Number","Percentage of Participants With Adverse Events (AEs)","From first dose of study drug until 8 weeks after last dose of study drug (up to 56 weeks)",null,"Systemic Lupus Erythematosus Responder-4 Index (SRI-4) up to Week 48|Area Under the Concentration-Time Curve From Time 0 to Time t (AUC0-t) of GDC-0853|Steady-State Concentration (Ctrough) of GDC-0853|Plasma Half-Life (t1/2) of GDC-0853|Apparent Clearance (CL/F) of GDC-0853","Baseline up to Week 48|Pre-dose (0 hour|Pre-dose (0 hr) at Weeks 0, 24, 48, at unscheduled or flare or early termination visit (up to Week 56)","hr) at Weeks 0, 24, 48, at unscheduled or flare or early termination visit (up to Week 56)",{"$nulls":3},"Buenos Aires, Argentina, C1194Aao Hospital Italiano De La PlataLa Plata, Argentina, 1900 Cer San Juan Centro Polivalente De Asistencia E Investigacion ClinicaSan Juan, Argentina, 5400 Centro MÃ©dico Privado De ReumatologÃ­aSan Miguel De Tucuman, Argentina, T4000Axl|Vitoria, Es, Brazil, 29055-450|Goiania, Go, Brazil, 74110-120|Juiz De Fora, Mg, Brazil, 36036-330|Curitiba, Pr, Brazil, 80440-080|Porto Alegre, Rs, Brazil, 90035-170|Itajai, Sc, Brazil, 88301-220|Santo Andre, Sp, Brazil, 09060-650 Centro Multidisciplinar De Estudos ClÃ­nicos - CemecSanto Andre, Sp, Brazil, 09190-510 Hospital Abreu SodrÃ© - AacdSao Paulo, Sp, Brazil, 04023-000 Cpclin - Centro De Pesquisas ClÃ­nicas Ltda.; Pesquisa ClinicaSÃ£o Paulo, Sp, Brazil, 01244-030|Plovdiv, Bulgaria, 4003 Medical Center \"Teodora\", EoodRuse, Bulgaria, 7000 Medical Center Excelsior OodSofia, Bulgaria, 1000 Umhat \"Sv. Ivan Rilski\", EadSofia, Bulgaria, 1431 Mc \"Synexus - Sofia\", EoodSofia, Bulgaria, 1784 Medical Center \"Nov Rehabilitatsionen Tsentar\", EoodStara Zagora, Bulgaria, 6000|Providencia, Chile, 7500571 DermacrossSantiago, Chile, 66901 Centro De Estudios ReumatologiSantiago, Chile, 7501126 BiomedicaSantiago, Chile|Barranquilla, Colombia, 00000 Centro De Investigacion Medico Asistencial S.A.SBarranquilla, Colombia, 80020 Medicity S.A.S.Bucaramanga, Colombia, 680003 Servimed S.A.S.Bucaramanga, Colombia, 680003 Hospital Pablo Tobon UribeMedellin, Colombia, 050034 Korea, Republic Of Eulji University HospitalDaejeon, Korea, Republic Of, 35233 Konkuk University Medical CenterSeoul, Korea, Republic Of, 05030|Torreon, Coahuila, Mexico, 27000|Cuernavaca, Mexico, 62290 Hospital Angeles Lindavista, Mexico, Mexico, 07760 Hospital Universitario De SaltilloSaltillo, Mexico, 25000 Hospital Central Dr. Ignacio Morones PrietoSan Luis Potosi S.L.P., Mexico, 78240|MÃ©rida, Yucatan, Mexico, 97000|Barcelona, Spain, 08035 Hospital General Universitario Gregorio MaraÃ±onMadrid, Spain, 28007 Hospital Clinico Universitario ValladolidValladolid, Spain, 47005 Hospital Universitario Rio HortegaValladolid, Spain, 47012 Taiwan Kaohsiung Chang Gung Memorial HospitalKaohsiung City, Taiwan, 00833 National Taiwan University HospitalTaipei, Taiwan, 10002 Chang Gung Memorial Hospital - LinkouTaoyuan, Taiwan, 333|A Coruna, La CoruÃ±a, Spain, 15006|London, United Kingdom, Se1 9Rt|Huntington Beach, California, United States, 92646 Valerius Medical GroupLos Alamitos, California, United States, 90720|Boca Raton, Florida, United States, 33486 Bay Area Arthritis And OsteoporosisBrandon, Florida, United States, 33511 Clinical Research Of West FloridaClearwater, Florida, United States, 33765|Idaho Falls, Idaho, United States, 83404|Wichita, Kansas, United States, 67208|Baton Rouge, Louisiana, United States, 70809|Boston, Massachusetts, United States, 02118|Raleigh, North Carolina, United States, 27617|Austin, Texas, United States, 78745 Accurate Clinical ResearchHouston, Texas, United States, 77058-3675 Accurate Clinical ResearchHouston, Texas, United States, 77089 Arthritis Clinic Of Central TexasSan Marcos, Texas, United States, 78666","California|Florida|Idaho|Kansas|Louisiana|Massachusetts|North Carolina|Texas","Argentina|Brazil|Bulgaria|Chile|Colombia|Mexico|Spain|United Kingdom|United States","Aprillus|Es Cedoes - DiagnÃ³stico E Pesquisa|Go Cip - Centro Internacional De Pesquisa|Mg Centro Mineiro De Pesquisa - Cmip|Pr Edumed - EducaÃ§Ã£o E SaÃºde Sa|Rs Centro De Pesquisas Em Diabetes - Cpd|Sc Clinica De Neoplasias Litoral|Sp Faculdade De Medicina Do Abc - Fmabc|Mhat Plovdiv|Ctr Estudios Spa|Centro Integral De Reumatologia Del Caribe Sas Circaribe Sas|Coahuila Centro De Investigacion Alberto Bazzoni S.A. De C.V.|Consultorio Particular Del Dr. Miguel Cortes Hernandez|Yucatan Unidad De Atencion Medica E Investigacion En Salud S.C.|Hospital Universitari Vall D'Hebron|La CoruÃ±a FundaciÃ³n Profesor Novoa Santos|Guy's Hospital; Louise Coote Lupus Unit|Hcp Clinical Research, Llc|Rasf-Clinical Research Center|Institute Of Arthritis Research|Via Christi Research, A Division Of Via Christi Hospitals Wichita, Inc.|Ochsner Clinic Foundation|Boston University Medical Center|Shanahan Rheumatology & Immunology, Pllc|Tekton Research Inc",{"$nulls":3},"Clinical Trials","2019-10-08","2020-05-25T16:38:13.535","2020-05-26T17:10:42.972","NCT03407482"]
["5ecbf475fe30261b1a048316","NCT03407482","2020-02-17","Genentech","DNA","Completed","An Extension Study of GDC-0853 in Participants With Moderate to Severe Active Systemic Lupus Erythematosus","Fenebrutinib","Btk Inhibitor","Yes","['Fenebrutinib']","No",null,"Phase 2",1,160,"Actual","2018-01-09","2019-11-20",{"$nulls":5},"This Phase II, multicenter, open-label extension (OLE) study will evaluate the long-term safety and efficacy of GDC-0853 in participants with systemic lupus erythematosus (SLE) who have completed Study GA30044 (NCT02908100) up to 48 weeks.",null,"A Phase II, Open-Label Extension Study of Patients Previously Enrolled in Study GA30044 to Evaluate the Long-Term Safety and Efficacy of GDC-0853 in Patients With Moderate to Severe Active Systemic Lupus Erythematosus","GA30066","Lupus Erythematosus, Systemic","Lupus Erythematosus|Lupus Erythematosus, Systemic|Erythema","Connective Tissue Diseases|Dermatological Diseases","Derm & Connective Tissue Disorders","Experimental","GDC-0853","Participants will receive GDC-0853 twice daily (BID) for 48 weeks, followed by a safety follow-up period of 8 weeks.","Drug","GDC-0853","Participants will receive 4 tablets of GDC-0853 orally BID.",null,"GDC-0853","\n\n * Able to comply with the study protocol, in the investigator's judgment\n * Completion of Study GA30044 up to 48 weeks\n * Acceptable safety and tolerability during Study GA30044 as determined by the investigator\n\n","\n\n * Met protocol-defined treatment-stopping criteria during Study GA30044\n * An adverse event in Study GA30044 that required permanent discontinuation of study drug\n * In the opinion of the investigator, any new, significant, uncontrolled comorbidity or new clinical manifestation (related to SLE or not) that requires medications not allowed in this protocol; or could put the participant at undue risk from a safety perspective\n * Any uncontrolled or clinically significant laboratory abnormality that would affect safety, interpretation of study data, or the participant's participation in the study in the opinion of the investigator in consultation with the Medical Monitor",{"$nulls":4},"Actual","2018-01-23","Actual","Actual","2019-11-20","Actual","2020-02-01","2018-01-15","2018-01-15","2020-02-13",null,null,"Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","18 Years","76 Years","All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"2017-001764-37","EudraCT Number","Percentage of Participants With Adverse Events (AEs)","From first dose of study drug until 8 weeks after last dose of study drug (up to 56 weeks)",null,"Systemic Lupus Erythematosus Responder-4 Index (SRI-4) up to Week 48|Area Under the Concentration-Time Curve From Time 0 to Time t (AUC0-t) of GDC-0853|Steady-State Concentration (Ctrough) of GDC-0853|Plasma Half-Life (t1/2) of GDC-0853|Apparent Clearance (CL/F) of GDC-0853","Baseline up to Week 48|Pre-dose (0 hour|Pre-dose (0 hr) at Weeks 0, 24, 48, at unscheduled or flare or early termination visit (up to Week 56)","hr) at Weeks 0, 24, 48, at unscheduled or flare or early termination visit (up to Week 56)",{"$nulls":3},"Buenos Aires, Argentina, C1194Aao Hospital Italiano De La PlataLa Plata, Argentina, 1900 Cer San Juan Centro Polivalente De Asistencia E Investigacion ClinicaSan Juan, Argentina, 5400 Centro MÃ©dico Privado De ReumatologÃ­aSan Miguel De Tucuman, Argentina, T4000Axl|Goiania, Go, Brazil, 74110-120|Juiz De Fora, Mg, Brazil, 36036-330|Curitiba, Pr, Brazil, 80440-080|Porto Alegre, Rs, Brazil, 90035-170|Itajai, Sc, Brazil, 88301-220|Santo Andre, Sp, Brazil, 09060-650 Centro Multidisciplinar De Estudos ClÃ­nicos - CemecSanto Andre, Sp, Brazil, 09190-510 Hospital Abreu SodrÃ© - AacdSao Paulo, Sp, Brazil, 04023-000 Cpclin - Centro De Pesquisas ClÃ­nicas Ltda.; Pesquisa ClinicaSÃ£o Paulo, Sp, Brazil, 01244-030|Plovdiv, Bulgaria, 4003 Medical Center \"Teodora\", EoodRuse, Bulgaria, 7000 Medical Center Excelsior OodSofia, Bulgaria, 1000 Umhat \"Sv. Ivan Rilski\", EadSofia, Bulgaria, 1431 Mc \"Synexus - Sofia\", EoodSofia, Bulgaria, 1784 Medical Center \"Nov Rehabilitatsionen Tsentar\", EoodStara Zagora, Bulgaria, 6000|Providencia, Chile, 7500571 DermacrossSantiago, Chile, 66901 Centro De Estudios ReumatologiSantiago, Chile, 7501126 BiomedicaSantiago, Chile|Barranquilla, Colombia, 00000 Centro De Investigacion Medico Asistencial S.A.SBarranquilla, Colombia, 80020 Medicity S.A.S.Bucaramanga, Colombia, 680003 Servimed S.A.S.Bucaramanga, Colombia, 680003 Hospital Pablo Tobon UribeMedellin, Colombia, 050034 Korea, Republic Of Eulji University HospitalDaejeon, Korea, Republic Of, 35233 Konkuk University Medical CenterSeoul, Korea, Republic Of, 05030|Torreon, Coahuila, Mexico, 27000|Saltillo, Mexico, 25000 Hospital Central Dr. Ignacio Morones PrietoSan Luis Potosi S.L.P., Mexico, 78240|MÃ©rida, Yucatan, Mexico, 97000|Barcelona, Spain, 08035 Hospital General Universitario Gregorio MaraÃ±onMadrid, Spain, 28007 Hospital Clinico Universitario ValladolidValladolid, Spain, 47005 Hospital Universitario Rio HortegaValladolid, Spain, 47012 Taiwan Kaohsiung Chang Gung Memorial HospitalKaohsiung City, Taiwan, 00833 National Taiwan University HospitalTaipei, Taiwan, 10002|A Coruna, La CoruÃ±a, Spain, 15006|London, United Kingdom, Se1 9Rt|Huntington Beach, California, United States, 92646 Valerius Medical GroupLos Alamitos, California, United States, 90720|Boca Raton, Florida, United States, 33486 Bay Area Arthritis And OsteoporosisBrandon, Florida, United States, 33511 Clinical Research Of West FloridaClearwater, Florida, United States, 33765|Idaho Falls, Idaho, United States, 83404|Wichita, Kansas, United States, 67208|Baton Rouge, Louisiana, United States, 70809|Boston, Massachusetts, United States, 02118|Raleigh, North Carolina, United States, 27617|Austin, Texas, United States, 78745 Accurate Clinical ResearchHouston, Texas, United States, 77058-3675 Accurate Clinical ResearchHouston, Texas, United States, 77089 Arthritis Clinic Of Central TexasSan Marcos, Texas, United States, 78666","California|Florida|Idaho|Kansas|Louisiana|Massachusetts|North Carolina|Texas","Argentina|Brazil|Bulgaria|Chile|Colombia|Mexico|Spain|United Kingdom|United States","Aprillus|Go Cip - Centro Internacional De Pesquisa|Mg Centro Mineiro De Pesquisa - Cmip|Pr Edumed - EducaÃ§Ã£o E SaÃºde Sa|Rs Centro De Pesquisas Em Diabetes - Cpd|Sc Clinica De Neoplasias Litoral|Sp Faculdade De Medicina Do Abc - Fmabc|Mhat Plovdiv|Ctr Estudios Spa|Centro Integral De Reumatologia Del Caribe Sas Circaribe Sas|Coahuila Centro De Investigacion Alberto Bazzoni S.A. De C.V.|Hospital Angeles Lindavista, Mexico, Mexico, 07760 Hospital Universitario De Saltillo|Yucatan Unidad De Atencion Medica E Investigacion En Salud S.C.|Hospital Universitari Vall D'Hebron|La CoruÃ±a FundaciÃ³n Profesor Novoa Santos|Guy's Hospital; Louise Coote Lupus Unit|Hcp Clinical Research, Llc|Rasf-Clinical Research Center|Institute Of Arthritis Research|Via Christi Research, A Division Of Via Christi Hospitals Wichita, Inc.|Ochsner Clinic Foundation|Boston University Medical Center|Shanahan Rheumatology & Immunology, Pllc|Tekton Research Inc",{"$nulls":3},"Clinical Trials","2020-02-13","2020-05-25T16:38:13.854","2020-05-26T17:10:42.972","NCT03407482"]
["5ecbf477307e3d1b1f8d9da9","NCT03407599","2018-07-12","Novo Nordisk","NVO","Completed","A Trial Comparing the Pharmacokinetic Properties of Fast-acting Insulin Aspart Between Children, Adolescents and Adults With Type 1 Diabetes","Insulin aspart","INSR Agonist","Unknown",null,"Unknown",null,"Phase 1",2,46,"Actual","2018-01-08","2018-07-05","AUC","Area Under The Curve",{"$nulls":3},"The study is done to compare how faster aspart is taken up, broken down and removed from the body between different age groups (children [6-11 years], adolescents [12-17 years] and adults [18-64 years]) who have diabetes. The blood sugar (glucose) lowering effect of faster aspart will also be investigated after consuming a meal replacement drink. The effects of faster aspart will be compared to the effects of NovoRapidÂ®.",null,"A Trial Comparing the Pharmacokinetic Properties of Fast-acting Insulin Aspart Between Children, Adolescents and Adults With Type 1 Diabetes","NN1218-4371","Diabetes\nDiabetes Mellitus, Type 1","Type 1 Diabetes","Metabolic Diseases","Nutritional Disorders","Experimental","Faster aspart followed by insulin aspart (NovoRapidÂ®)|Insulin aspart (NovoRapidÂ®) followed by faster aspart","Participants will receive single dose of fast-acting insulin aspart followed by single dose of NovoRapidÂ® on two separate dosing visits. The dosing visits will be separated by a wash-out period of 3-22 days.|Participants will receive single dose of NovoRapidÂ® followed by single dose of fast-acting insulin aspart on two separate dosing visits. The dosing visits will be separated by a wash-out period of 3-22 days.","Drug","Faster aspart|Insulin aspart (NovoRapid&#xAE;)","An injection of fast-acting insulin aspart 0.2 U/kg body weight under the skin just prior to a standard meal.|An injection of insulin aspart (NovoRapidÂ®) 0.2 U/kg body weight under the skin just prior to a standard meal.",null,"Faster aspart followed by insulin aspart (NovoRapidÂ®)|Insulin aspart (NovoRapidÂ®) followed by faster aspart","\n\n * Male or female aged 6-64 years (both inclusive) at the time of signing informed consent\n * Diagnosed with type 1 diabetes greater than or equal to 12 months prior to the day of screening\n * Body mass index for children and adolescents (male and female) between the 3rd and 97th BMI percentile and for adults less than or equal to 28.0 kg/sqm\n\n","\n\n * Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening\n * Smoker (defined as a subject who is smoking at least one cigarette, cigar or pipe daily)\n * Not able or willing to refrain from smoking and use of nicotine substitute products during the inpatient period",{"$nulls":4},"Actual","2018-01-23","Actual","Actual","2018-07-05","Actual","2018-07-01","2018-01-05","2018-01-16","2018-07-10","No",null,"Interventional","Treatment","Crossover Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","6 Years","64 Years","All",null,"No","Yes\nAccording to the Novo Nordisk disclosure commitment on novonordisk-trials.com",{"$nulls":3},"Yes","No",{"$nulls":4},"Yes",{"$nulls":12},"2017-002014-31|U1111-1197-0428","Registry Identifier: European Medicines Agency (EudraCT)|World Health Organization (WHO)","AUC(IAsp),0-12h, area under the serum insulin aspart concentration-time curve from 0 to 12 hours","Calculated based on insulin aspart measured in blood.","0-12 hours","AUCIAsp,0-15min, area under the serum insulin aspart concentration-time curve 0 to 15 minutes|AUCIAsp,0-30min, area under the serum insulin aspart concentration-time curve from 0 to 30 minutes|AUCIAsp,0-1hr, area under the serum insulin aspart concentration-time curve from 0 to 1 hour|AUCIAsp,0-1Â½hr, area under the serum insulin aspart concentration-time curve from 0 to 1Â½ hour|AUCIAsp,0-2hr, area under the serum insulin aspart concentration-time curve from 0 to 2 hours|Cmax,IAsp, maximum observed serum insulin aspart concentration|tmax,IAsp, time to maximum observed serum insulin aspart concentration|Onset of appearanceIAsp, time from trial product administration until the first time serum insulinaspart concentration greater than or equal to Lower Limit Of Quantitation (LLOQ)|Duration of exposureIAsp, time from trial product administration until the first time serum insulin aspart concentration is equal to LLOQ in the terminal part of the curve|Time to 50% Cmax, IAsp, the first time point where the insulin aspart concentration equals 50% of Cmax,IAsp|Time to late 50% Cmax,IAsp, the last time point where the insulin aspart concentration equals 50% of Cmax,IAsp|Mean change in plasma glucose concentration from 0-1 hour after administration|Mean change in plasma glucose concentration from 0-2 hours after administration|Mean change in plasma glucose concentration from 0-6 hours after administration|Change from baseline in plasma glucose concentration 1 hour after administration|Change from baseline in plasma glucose concentration 2 hours after administration|Plasma glucose concentration 1 hour after administration|Plasma glucose concentration 2 hours after administration|Maximum plasma glucose excursion after administration|Maximum plasma glucose concentration after administration|Time to maximum plasma glucose concentration after administration|Minimum plasma glucose concentration after administration|Number of adverse events|Number of hypoglycaemic episodes","Calculated based on insulin aspart measured in blood.|Calculated based on glucose concentration measured in plasma.|Count of events|Count of hypoglycaemic episodes","0-15 minutes|0-30 minutes|0-1 hour|0-1Â½ hour|0-2 hours|0-12 hours|0-6 hours|Pre-dose (0 hour), 1 hour|Pre-dose (0 hour), 2 hours|1 hour after administration|2 hours after administration|From screening day 1 up to the study completion day 68",{"$nulls":3},"Hannover, Germany, 30173",null,"Germany","Novo Nordisk Investigational Site",{"$nulls":3},"Clinical Reporting Anchor and Disclosure (1452)","2018-07-10","2020-05-25T16:38:15.042","2020-05-26T17:10:42.972","NCT03407599"]
["5ecbf47afeab101b1553094f","NCT03408470","2018-01-30","Theravance Biopharma","TBPH","Recruiting","TD-1473 Absorption, Distribution, Metabolism and Excretion (ADME) Study in Healthy Male Subjects","Td-1473","JAK Inhibitor","Yes","['Td-1473']","No",null,"Phase 1",2,20,"Anticipated","2018-01-31","2018-02-21","AUC|Clast","Area Under The Curve|Last Quantifiable Plasma Concentration",{"$nulls":3},"This is an open-label, 2-cohort study to evaluate the absolute bioavailability, absorption, distribution, metabolism and excretion of TD-1473 in healthy male subjects. Subjects in cohort 1 will receive a single oral dose of TD-1473 and a single intravenous bolus dose of [14C]-TD-1473. Subjects in cohort 2 will receive a single oral dose of [14C]-TD-1473 only.",null,"A 2-Cohort Study to Evaluate the Absolute Bioavailability, Absorption, Distribution, Metabolism and Excretion of TD-1473 Following an Intravenous and an Oral Dose of [14C]-TD-1473 in Healthy Male Subjects",152,"Intestinal Disorders\nBowel Diseases, Inflammatory","Inflammatory Bowel Diseases","Gastrointestinal Diseases","Gastrointestinal","Experimental","TD-1473 Oral Capsule & [14C]-TD-1473 IV bolus|[14C]-TD-1473 Oral Capsule","Cohort 1 - One oral dose and IV bolus administered 1 hr after oral dose of TD-1473|Cohort 2 - One oral dose","Drug","TD-1473 oral capsule|[14C]-TD-1473 IV bolus|[14C]-TD-1473 Oral Capsule","(Intervention description included in arm description)",null,"TD-1473 Oral Capsule & [14C]-TD-1473 IV bolus|[14C]-TD-1473 Oral Capsule","\n\n * Subject is a healthy, nonsmoking male, 19 to 55 years old, inclusive\n * Subject has a body mass index (BMI) 19 to 32 kg/m2, inclusive, and weighs at least 50 kg\n * Subject is healthy as determined by the PI or designee based on medical history and physical examination performed at Screening and Day -1\n * Additional inclusion criteria apply\n\n","\n\n * Subject has any condition possibly affecting drug absorption (e.g., previous surgery on the gastrointestinal tract [including removal of parts of the stomach, bowel, liver, gall bladder, or pancreas])\n * Subject has a known hypersensitivity towards medications similar to TD 1473 or excipients contained in TD 1473\n * Subject regularly works with ionizing radiation or radioactive material\n * Subject has been exposed to ionizing radiations, within 1 year prior to the start of the study, as external irradiation (i.e., radiological examination including CT scan, excluding dental radiography) or internal radiation (i.e., diagnostic nuclear medicine procedure) or have participated in a radiolabeled study in the last 12 months\n * Subject, who, for any reason, is deemed by the PI or designee or Sponsor to be inappropriate for this study or have any condition which would confound or interfere with the evaluation of the safety, tolerability, and PK of the investigational drug or prevent compliance with the study protocol\n * Additional exclusion criteria apply",{"$nulls":4},"Actual","2018-01-24","Actual","Anticipated","2018-04-30","Anticipated","2018-01-01","2018-01-12","2018-01-22","2018-01-26","No","Absolute Bioavailability\nADME\nHealthy Normal Males","Interventional","Basic Science","Parallel Assignment","None (Open Label)","Randomized","19 Years","55 Years","Male","Yes","Yes","Undecided",{"$nulls":3},"Yes","No",{"$nulls":19},"Maximum observed concentration (Cmax) in Plasma|Time to maximum observed concentration (tmax) in Plasma|Area under the concentration-time curve from hour 0 to the last measurable concentration (AUC0-last) in Plasma|Area under the concentration-time curve extrapolated to infinity (AUC0-inf) in Plasma|Apparent terminal elimination half-life (t1/2) in Plasma|Apparent clearance (Cl/F) in Plasma|Apparent volume of distribution (Vz/F) in Plasma|Absolute bioavailability (%F) in Plasma","Up to 15 days",null,"Amount excreted in urine (Aeu) over the sampling interval in Urine|Renal clearance (CLr) in Urine|The percent excreted in urine (%Feu) in Urine|Amount excreted in feces (Aef) over the sampling interval in Feces|The percent excreted in feces (%Fef)|Other Pre-specified Outcome Measures:|Metabolites in Plasma|Metabolites in Urine|Metabolites in Feces","Up to 15 days|Other Pre-specified Outcome Measures:|TD 1473 metabolite profiling will be performed in plasma containing sufficient amounts of radioactivity|TD 1473 metabolite profiling will be performed in urine containing sufficient amounts of radioactivity|TD-1473 metabolite profiling will be performed in feces containing sufficient amounts of radioactivity","Up to 15 days","KChiu@theravance.com","Kit Chiu, MS, PhD","650-808-6000","Lincoln, Nebraska, United States, 68502","Nebraska","United States","Celerion",{"$nulls":3},"Brian Ferslew, PhD","2018-01-26","2020-05-25T16:38:18.938","2020-05-26T17:10:42.972","NCT03408470"]
["5ecbf47a307e3d1b1f8d9db1","NCT03408470","2018-04-17","Theravance Biopharma","TBPH","Completed","TD-1473 Absorption, Distribution, Metabolism and Excretion (ADME) Study in Healthy Male Subjects","Td-1473","JAK Inhibitor","Yes","['Td-1473']","No",null,"Phase 1",2,20,"Actual","2018-01-31","2018-02-21","AUC|Clast","Area Under The Curve|Last Quantifiable Plasma Concentration",{"$nulls":3},"This is an open-label, 2-cohort study to evaluate the absolute bioavailability, absorption, distribution, metabolism and excretion of TD-1473 in healthy male subjects. Subjects in cohort 1 will receive a single oral dose of TD-1473 and a single intravenous bolus dose of [14C]-TD-1473. Subjects in cohort 2 will receive a single oral dose of [14C]-TD-1473 only.",null,"A 2-Cohort Study to Evaluate the Absolute Bioavailability, Absorption, Distribution, Metabolism and Excretion of TD-1473 Following an Intravenous and an Oral Dose of [14C]-TD-1473 in Healthy Male Subjects",152,"Intestinal Disorders\nBowel Diseases, Inflammatory","Inflammatory Bowel Diseases","Gastrointestinal Diseases","Gastrointestinal","Experimental","TD-1473 Oral Capsule & [14C]-TD-1473 IV bolus|[14C]-TD-1473 Oral Capsule","Cohort 1 - One oral dose and IV bolus administered 1 hr after oral dose of TD-1473|Cohort 2 - One oral dose","Drug","TD-1473 oral capsule|[14C]-TD-1473 IV bolus|[14C]-TD-1473 Oral Capsule","(Intervention description included in arm description)",null,"TD-1473 Oral Capsule & [14C]-TD-1473 IV bolus|[14C]-TD-1473 Oral Capsule","\n\n * Subject is a healthy, nonsmoking male, 19 to 55 years old, inclusive\n * Subject has a body mass index (BMI) 19 to 32 kg/m2, inclusive, and weighs at least 50 kg\n * Subject is healthy as determined by the PI or designee based on medical history and physical examination performed at Screening and Day -1\n * Additional inclusion criteria apply\n\n","\n\n * Subject has any condition possibly affecting drug absorption (e.g., previous surgery on the gastrointestinal tract [including removal of parts of the stomach, bowel, liver, gall bladder, or pancreas])\n * Subject has a known hypersensitivity towards medications similar to TD 1473 or excipients contained in TD 1473\n * Subject regularly works with ionizing radiation or radioactive material\n * Subject has been exposed to ionizing radiations, within 1 year prior to the start of the study, as external irradiation (i.e., radiological examination including CT scan, excluding dental radiography) or internal radiation (i.e., diagnostic nuclear medicine procedure) or have participated in a radiolabeled study in the last 12 months\n * Subject, who, for any reason, is deemed by the PI or designee or Sponsor to be inappropriate for this study or have any condition which would confound or interfere with the evaluation of the safety, tolerability, and PK of the investigational drug or prevent compliance with the study protocol\n * Additional exclusion criteria apply",{"$nulls":4},"Actual","2018-01-24","Actual","Actual","2018-02-21","Actual","2018-04-01","2018-01-12","2018-01-22","2018-04-13","No","Absolute Bioavailability\nADME\nHealthy Normal Males","Interventional","Basic Science","Parallel Assignment","None (Open Label)","Randomized","19 Years","55 Years","Male","Yes","Yes",{"$nulls":4},"Yes","No",{"$nulls":19},"Maximum observed concentration (Cmax) in Plasma|Time to maximum observed concentration (tmax) in Plasma|Area under the concentration-time curve from hour 0 to the last measurable concentration (AUC0-last) in Plasma|Area under the concentration-time curve extrapolated to infinity (AUC0-inf) in Plasma|Apparent terminal elimination half-life (t1/2) in Plasma|Apparent clearance (Cl/F) in Plasma|Apparent volume of distribution (Vz/F) in Plasma|Absolute bioavailability (%F) in Plasma","Up to 15 days",null,"Amount excreted in urine (Aeu) over the sampling interval in Urine|Renal clearance (CLr) in Urine|The percent excreted in urine (%Feu) in Urine|Amount excreted in feces (Aef) over the sampling interval in Feces|The percent excreted in feces (%Fef)|Other Pre-specified Outcome Measures:|Metabolites in Plasma|Metabolites in Urine|Metabolites in Feces","Up to 15 days|Other Pre-specified Outcome Measures:|TD 1473 metabolite profiling will be performed in plasma containing sufficient amounts of radioactivity|TD 1473 metabolite profiling will be performed in urine containing sufficient amounts of radioactivity|TD-1473 metabolite profiling will be performed in feces containing sufficient amounts of radioactivity","Up to 15 days",{"$nulls":3},"Lincoln, Nebraska, United States, 68502","Nebraska","United States","Celerion",{"$nulls":3},"Brian Ferslew, PhD","2018-04-13","2020-05-25T16:38:18.929","2020-05-26T17:10:42.972","NCT03408470"]
["5ecbf47be2561b1b11905e1b","NCT03408587","2018-03-21","Viralytics","VRACY","Recruiting","CAVATAKÂ® and Ipilimumab in Uveal Melanoma Metastatic to the Liver (VLA-024 CLEVER) (CLEVER)","Cva-21|Ipilimumab","CD55 Inhibitor|CTLA4 Inhibitor","Yes","['Cva-21']","Yes","['CD55 Inhibitor']","Phase 1",1,10,"Anticipated","2017-12-20","2019-12-15",{"$nulls":5},"This is an open-label Phase 1b clinical study of ipilimumab in combination with intravenous CVA21 in subjects who have uveal melanoma metastatic to liver.","This is an open-label Phase 1b clinical study of ipilimumab in combination with intravenous CVA21 in subjects who have uveal melanoma metastatic to liver. Subjects will receive up to 8 cycles of CVA21 at a planned dose of 1 x 10e9 TCID50 per infusion, with the first cycle being a 28-day cycle consisting of an intravenous infusion on Days 1, 3, 5 and 8 and subsequent cycles every 21 days from Day 8.\n\nIpilimumab will be given by intravenous administration at a dose of 3mg/kg, for a maximum of 4 doses, given on Days 8, 29, 50 and 71. On days when both CVA21 and ipilimumab are given, CVA21 will be given first.\n\nSubjects will be monitored for treatment toxicity using the current version of CTCAE.","An Open-Label Phase 1b Clinical Study of Intravenous CAVATAKÂ® (Coxsackievirus A21, CVA21), in Combination With Ipilimumab in Subjects With Uveal Melanoma Metastatic to Liver (VLA-024 CLEVER)","VLA-024","Uveal Melanoma\nLiver Metastases","Noma|Melanoma","Mouth Diseases|Oncology Solid Tumor","Ear, Nose and Throat|Oncology","Experimental","CVA21 / Ipilimumab","Subjects will receive up to 8 cycles (Day 155) of intravenous CVA21 and 4 doses of ipilimumab (Days 8, 29, 50 and 71).","Biological","CVA21|Ipilimumab","Oncolytic virus|Fully human IgG1 monoclonal antibody that binds to the CTLA-4 receptor expressed on activated T cells.","CAVATAK, Coxsackievirus A21|Yervoy","CVA21 / Ipilimumab","\n\n 1.  Histologic or cytologically confirmed diagnosis of uveal melanoma with measurable disease (based on RECIST 1.1 criteria) in the liver (by CT, PET/CT or MRI) at the time of screening.\n 2.  Patients that have had prior treatment must show disease progression during or following the last treatment according to RECIST 1.1 criteria.\n 3.  Men and women â‰¥ 18 years of age.\n 4.  The subject has a life expectancy of greater than 12 weeks.\n 5.  The subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n 6.  Adequate organ function as defined by and obtained within 28 days of starting treatment: * Absolute neutrophil count â‰¥ 1,500 /mcl\n      * WBC â‰¥ 3.0 x 10e9/L\n      * Platelets â‰¥ 100,000 /mcl\n      * Hemoglobin â‰¥ 9 g/dL\n      * Creatinine â‰¤ 1.5 x ULN\n      * Albumin > 3 g/dL\n      * Total bilirubin â‰¤ 1.5 x ULN or direct bilirubin â‰¤ ULN for subjects with total bilirubin > 1.5 x ULN\n      * AST and ALT â‰¤ 5 x ULN\n      * INR or PT â‰¤ 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT and PTT are within therapeutic range of intended use of anticoagulants.\n      * aPTT â‰¤ 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT and PTT are within therapeutic range of intended use of anticoagulants.\n     \n     \n 7.  Prior therapy with an immune checkpoint inhibitor therapy is allowable. A 6-week washout period will be required for those with prior PD-1 or PD-L1 treatment.\n 8.  Female subjects of child-bearing potential must have a negative urine pregnancy test within 72 hours prior to receiving the first dose of study medication. If a urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n 9.  Female and Male subjects of childbearing potential must be willing to use an adequate method of contraception, starting with the first dose of study drug through 4 weeks after the last dose of study drug. Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.\n 10. The subject is capable of understanding and complying with protocol requirements.\n 11. The subject or the subject's legally acceptable representative provides written, informed consent prior to the initiation of any study procedures.\n\n","\n\n 1.  The subject is a candidate for surgery or loco-regional treatment with curative intent.\n 2.  Subjects with active (i.e. symptomatic or growing) central nervous system (CNS) metastases. Subjects with CNS metastases are eligible if the metastases have been treated with surgery and/or radiotherapy, the subject is off corticosteroids for at least 2 weeks and the subject is neurologically stable.\n 3.  Known additional malignancy that is progressing or requires active treatment. Exceptions include cutaneous squamous cell or basal cell carcinoma that has undergone potentially curative therapy or in-situ cervical cancer.\n 4.  Known history of Human Immunodeficiency Virus (HIV, HIV 1/2 antibodies), known active Hepatitis B (e.g. HBsAg reactive) or Hepatitis C (e.g. HCV RNA [qualitative] is detected).\n 5.  Current systemic steroid therapy other than physiologic replacement (i.e. prednisone â‰¤ 10 mg or equivalent). Inhaled or topical steroid use is allowed.\n 6.  Active auto-immune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is allowed.\n 7.  Active colitis or previous immune-mediated colitis that has not resolved to grade 1 or less.\n 8.  Chemotherapy, targeted small molecule therapy, radiation therapy, hormonal treatment or immunotherapy within 21 days prior to initiation of treatment. A 6-week washout period will be required for those with prior PD-1 or PD-L1 treatment. Subjects must have resolution of toxic effect(s) of the most recent therapy to Grade 1 or less. Exceptions are subjects with â‰¤ Grade 2 alopecia or â‰¤ Grade 2 neuropathy who are permitted in the study. If the subject received major surgery or radiation therapy of >30 Gy, they must have recovered from the toxicity and/or any complications from the intervention.\n 9.  Pregnancy, breastfeeding, or expectation to conceive or father children within the projected duration of the trial, starting with the screening visit through 4 weeks after the last dose of study treatment.\n 10. Known sensitivity to any of the products or components to be administered during dosing.\n 11. Participation in a study of an investigational agent or device within 4 weeks of Day 1.\n 12. Subjects with any other concurrent, uncontrolled illness, including known psychiatric or substance abuse disorders which may interfere with the ability of the subject to cooperate and participate in the trial. Other examples of such conditions would include unstable angina, myocardial infarction (MI) or cerebrovascular accident (CVA) within 6 months of study entry.\n 13. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.\n 14. Patients with tumors lying close to an airway, major blood vessel or spinal cord that, in the opinion of the investigator, could cause occlusion or compression in the case of swelling, or erosion into a major vessel in the case of necrosis.",{"$nulls":4},"Actual","2018-01-24","Actual","Anticipated","2020-05-15","Anticipated","2018-03-01","2018-01-10","2018-01-23","2018-03-19",null,"CVA21\nCAVATAK\nCoxsackievirus\nocular\neye\nipilimumab\nyervoy\noncolytic\nvirus\ncheckpoint\nCTLA-4","Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No",null,null,"URL: https://www.viralytics.com/ [https://www.viralytics.com/] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: Viralytics website",null,"Yes","No",{"$nulls":19},"Incidence of treatment-related adverse events as assessed using the current NCI-CTCAE.","Treatment-emergent adverse events (TEAEs) are defined as AEs that start on or after the first day of study treatment and within 30 days of the last administration of study treatment. The incidence of TEAEs will be summarized based on the number and percentage of subjects who experience events classified by MedDRA system organ class and preferred term.","30 days from the last administration of study treatment","Overall Response Rate","Objective responses will be assessed according to immune-related Response Evaluation Criteria In Solid Tumors (irRECIST) criteria","2 years",{"$nulls":3},"Miami Beach, Florida, United States, 33140|Boston, Massachusetts, United States, 02215","Florida|Massachusetts","United States","Mount Sinai Medical Center|Dana-Farber Cancer Institute",{"$nulls":4},"2018-03-19","2020-05-25T16:38:19.139","2020-05-26T17:10:42.972","NCT03408587"]
["5ecbf47be2561b1b11905e1c","NCT03408587","2018-07-02","Viralytics","VRACY","Recruiting","CAVATAKÂ® and Ipilimumab in Uveal Melanoma Metastatic to the Liver (VLA-024 CLEVER) (CLEVER)","Cva-21|Ipilimumab","CD55 Inhibitor|CTLA4 Inhibitor","Yes","['Cva-21']","Yes","['CD55 Inhibitor']","Phase 1",1,10,"Anticipated","2017-12-20","2019-12-15",{"$nulls":5},"This is an open-label Phase 1b clinical study of ipilimumab in combination with intravenous CVA21 in subjects who have uveal melanoma metastatic to liver.","This is an open-label Phase 1b clinical study of ipilimumab in combination with intravenous CVA21 in subjects who have uveal melanoma metastatic to liver. Subjects will receive up to 8 cycles of CVA21 at a planned dose of 1 x 10e9 TCID50 per infusion, with the first cycle being a 28-day cycle consisting of an intravenous infusion on Days 1, 3, 5 and 8 and subsequent cycles every 21 days from Day 8.\n\nIpilimumab will be given by intravenous administration at a dose of 3mg/kg, for a maximum of 4 doses, given on Days 8, 29, 50 and 71. On days when both CVA21 and ipilimumab are given, CVA21 will be given first.\n\nSubjects will be monitored for treatment toxicity using the current version of CTCAE.","An Open-Label Phase 1b Clinical Study of Intravenous CAVATAKÂ® (Coxsackievirus A21, CVA21), in Combination With Ipilimumab in Subjects With Uveal Melanoma Metastatic to Liver (VLA-024 CLEVER)","VLA-024","Uveal Melanoma\nLiver Metastases","Noma|Melanoma","Mouth Diseases|Oncology Solid Tumor","Ear, Nose and Throat|Oncology","Experimental","CVA21 / Ipilimumab","Subjects will receive up to 8 cycles (Day 155) of intravenous CVA21 and 4 doses of ipilimumab (Days 8, 29, 50 and 71).","Biological","CVA21|Ipilimumab","Oncolytic virus|Fully human IgG1 monoclonal antibody that binds to the CTLA-4 receptor expressed on activated T cells.","CAVATAK, Coxsackievirus A21|Yervoy","CVA21 / Ipilimumab","\n\n 1.  Histologic or cytologically confirmed diagnosis of uveal melanoma with measurable disease (based on RECIST 1.1 criteria) in the liver (by CT, PET/CT or MRI) at the time of screening.\n 2.  Patients that have had prior treatment must show disease progression during or following the last treatment according to RECIST 1.1 criteria.\n 3.  Men and women â‰¥ 18 years of age.\n 4.  The subject has a life expectancy of greater than 12 weeks.\n 5.  The subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n 6.  Adequate organ function as defined by and obtained within 28 days of starting treatment: * Absolute neutrophil count â‰¥ 1,500 /mcl\n      * WBC â‰¥ 3.0 x 10e9/L\n      * Platelets â‰¥ 100,000 /mcl\n      * Hemoglobin â‰¥ 9 g/dL\n      * Creatinine â‰¤ 1.5 x ULN\n      * Albumin > 3 g/dL\n      * Total bilirubin â‰¤ 1.5 x ULN or direct bilirubin â‰¤ ULN for subjects with total bilirubin > 1.5 x ULN\n      * AST and ALT â‰¤ 5 x ULN\n      * INR or PT â‰¤ 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT and PTT are within therapeutic range of intended use of anticoagulants.\n      * aPTT â‰¤ 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT and PTT are within therapeutic range of intended use of anticoagulants.\n     \n     \n 7.  Prior therapy with an immune checkpoint inhibitor therapy is allowable. A 6-week washout period will be required for those with prior PD-1 or PD-L1 treatment.\n 8.  Female subjects of child-bearing potential must have a negative urine pregnancy test within 72 hours prior to receiving the first dose of study medication. If a urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n 9.  Female and Male subjects of childbearing potential must be willing to use an adequate method of contraception, starting with the first dose of study drug through 4 weeks after the last dose of study drug. Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.\n 10. The subject is capable of understanding and complying with protocol requirements.\n 11. The subject or the subject's legally acceptable representative provides written, informed consent prior to the initiation of any study procedures.\n\n","\n\n 1.  The subject is a candidate for surgery or loco-regional treatment with curative intent.\n 2.  Subjects with active (i.e. symptomatic or growing) central nervous system (CNS) metastases. Subjects with CNS metastases are eligible if the metastases have been treated with surgery and/or radiotherapy, the subject is off corticosteroids for at least 2 weeks and the subject is neurologically stable.\n 3.  Known additional malignancy that is progressing or requires active treatment. Exceptions include cutaneous squamous cell or basal cell carcinoma that has undergone potentially curative therapy or in-situ cervical cancer.\n 4.  Known history of Human Immunodeficiency Virus (HIV, HIV 1/2 antibodies), known active Hepatitis B (e.g. HBsAg reactive) or Hepatitis C (e.g. HCV RNA [qualitative] is detected).\n 5.  Current systemic steroid therapy other than physiologic replacement (i.e. prednisone â‰¤ 10 mg or equivalent). Inhaled or topical steroid use is allowed.\n 6.  Active auto-immune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is allowed.\n 7.  Active colitis or previous immune-mediated colitis that has not resolved to grade 1 or less.\n 8.  Chemotherapy, targeted small molecule therapy, radiation therapy, hormonal treatment or immunotherapy within 21 days prior to initiation of treatment. A 6-week washout period will be required for those with prior PD-1 or PD-L1 treatment. Subjects must have resolution of toxic effect(s) of the most recent therapy to Grade 1 or less. Exceptions are subjects with â‰¤ Grade 2 alopecia or â‰¤ Grade 2 neuropathy who are permitted in the study. If the subject received major surgery or radiation therapy of >30 Gy, they must have recovered from the toxicity and/or any complications from the intervention.\n 9.  Pregnancy, breastfeeding, or expectation to conceive or father children within the projected duration of the trial, starting with the screening visit through 4 weeks after the last dose of study treatment.\n 10. Known sensitivity to any of the products or components to be administered during dosing.\n 11. Participation in a study of an investigational agent or device within 4 weeks of Day 1.\n 12. Subjects with any other concurrent, uncontrolled illness, including known psychiatric or substance abuse disorders which may interfere with the ability of the subject to cooperate and participate in the trial. Other examples of such conditions would include unstable angina, myocardial infarction (MI) or cerebrovascular accident (CVA) within 6 months of study entry.\n 13. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.\n 14. Patients with tumors lying close to an airway, major blood vessel or spinal cord that, in the opinion of the investigator, could cause occlusion or compression in the case of swelling, or erosion into a major vessel in the case of necrosis.",{"$nulls":4},"Actual","2018-01-24","Actual","Anticipated","2020-05-15","Anticipated","2018-06-01","2018-01-10","2018-01-23","2018-06-28",null,"CVA21\nCAVATAK\nCoxsackievirus\nocular\neye\nipilimumab\nyervoy\noncolytic\nvirus\ncheckpoint\nCTLA-4","Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No",null,null,"URL: https://www.viralytics.com/ [https://www.viralytics.com/] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: Viralytics website",null,"Yes","No",{"$nulls":19},"Incidence of treatment-related adverse events as assessed using the current NCI-CTCAE.","Treatment-emergent adverse events (TEAEs) are defined as AEs that start on or after the first day of study treatment and within 30 days of the last administration of study treatment. The incidence of TEAEs will be summarized based on the number and percentage of subjects who experience events classified by MedDRA system organ class and preferred term.","30 days from the last administration of study treatment","Overall Response Rate","Objective responses will be assessed according to immune-related Response Evaluation Criteria In Solid Tumors (irRECIST) criteria","2 years",{"$nulls":3},"Miami Beach, Florida, United States, 33140|Boston, Massachusetts, United States, 02114","Florida|Massachusetts","United States","Mount Sinai Medical Center|Massachusetts General Hospital",{"$nulls":4},"2018-06-28","2020-05-25T16:38:19.524","2020-05-26T17:10:42.972","NCT03408587"]
["5ecbf47b11702c1b1b916b30","NCT03408587","2019-04-08","Viralytics","VRACY","Active, not recruiting","CAVATAKÂ® and Ipilimumab in Uveal Melanoma Metastatic to the Liver (VLA-024 CLEVER) (CLEVER)","Cva-21|Ipilimumab","CD55 Inhibitor|CTLA4 Inhibitor","Yes","['Cva-21']","Yes","['CD55 Inhibitor']","Phase 1",1,10,"Anticipated","2017-12-08","2020-01-14",{"$nulls":5},"This is an open-label Phase 1b clinical study of ipilimumab in combination with intravenous CVA21 in subjects who have uveal melanoma metastatic to liver.","This is an open-label Phase 1b clinical study of ipilimumab in combination with intravenous CVA21 in subjects who have uveal melanoma metastatic to liver. Subjects will receive up to 8 cycles of CVA21 at a planned dose of 1 x 10e9 TCID50 per infusion, with the first cycle being a 28-day cycle consisting of an intravenous infusion on Days 1, 3, 5 and 8 and subsequent cycles every 21 days from Day 8.\n\nIpilimumab will be given by intravenous administration at a dose of 3mg/kg, for a maximum of 4 doses, given on Days 8, 29, 50 and 71. On days when both CVA21 and ipilimumab are given, CVA21 will be given first.\n\nSubjects will be monitored for treatment toxicity using the current version of CTCAE.","An Open-Label Phase 1b Clinical Study of Intravenous CAVATAKÂ® (Coxsackievirus A21, CVA21), in Combination With Ipilimumab in Subjects With Uveal Melanoma Metastatic to Liver (VLA-024 CLEVER)","VLA-024","Uveal Melanoma\nLiver Metastases","Noma|Melanoma","Mouth Diseases|Oncology Solid Tumor","Ear, Nose and Throat|Oncology","Experimental","CVA21 / Ipilimumab","Subjects will receive up to 8 cycles (Day 155) of intravenous CVA21 and 4 doses of ipilimumab (Days 8, 29, 50 and 71).","Biological","CVA21|Ipilimumab","Oncolytic virus|Fully human IgG1 monoclonal antibody that binds to the CTLA-4 receptor expressed on activated T cells.","CAVATAK, Coxsackievirus A21|Yervoy","CVA21 / Ipilimumab","\n\n 1.  Histologic or cytologically confirmed diagnosis of uveal melanoma with measurable disease (based on RECIST 1.1 criteria) in the liver (by CT, PET/CT or MRI) at the time of screening.\n 2.  Patients that have had prior treatment must show disease progression during or following the last treatment according to RECIST 1.1 criteria.\n 3.  Men and women â‰¥ 18 years of age.\n 4.  The subject has a life expectancy of greater than 12 weeks.\n 5.  The subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n 6.  Adequate organ function as defined by and obtained within 28 days of starting treatment: * Absolute neutrophil count â‰¥ 1,500 /mcl\n      * WBC â‰¥ 3.0 x 10e9/L\n      * Platelets â‰¥ 100,000 /mcl\n      * Hemoglobin â‰¥ 9 g/dL\n      * Creatinine â‰¤ 1.5 x ULN\n      * Albumin > 3 g/dL\n      * Total bilirubin â‰¤ 1.5 x ULN or direct bilirubin â‰¤ ULN for subjects with total bilirubin > 1.5 x ULN\n      * AST and ALT â‰¤ 5 x ULN\n      * INR or PT â‰¤ 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT and PTT are within therapeutic range of intended use of anticoagulants.\n      * aPTT â‰¤ 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT and PTT are within therapeutic range of intended use of anticoagulants.\n     \n     \n 7.  Prior therapy with an immune checkpoint inhibitor therapy is allowable. A 6-week washout period will be required for those with prior PD-1 or PD-L1 treatment.\n 8.  Female subjects of child-bearing potential must have a negative urine pregnancy test within 72 hours prior to receiving the first dose of study medication. If a urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n 9.  Female and Male subjects of childbearing potential must be willing to use an adequate method of contraception, starting with the first dose of study drug through 4 weeks after the last dose of study drug. Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.\n 10. The subject is capable of understanding and complying with protocol requirements.\n 11. The subject or the subject's legally acceptable representative provides written, informed consent prior to the initiation of any study procedures.\n\n","\n\n 1.  The subject is a candidate for surgery or loco-regional treatment with curative intent.\n 2.  Subjects with active (i.e. symptomatic or growing) central nervous system (CNS) metastases. Subjects with CNS metastases are eligible if the metastases have been treated with surgery and/or radiotherapy, the subject is off corticosteroids for at least 2 weeks and the subject is neurologically stable.\n 3.  Known additional malignancy that is progressing or requires active treatment. Exceptions include cutaneous squamous cell or basal cell carcinoma that has undergone potentially curative therapy or in-situ cervical cancer.\n 4.  Known history of Human Immunodeficiency Virus (HIV, HIV 1/2 antibodies), known active Hepatitis B (e.g. HBsAg reactive) or Hepatitis C (e.g. HCV RNA [qualitative] is detected).\n 5.  Current systemic steroid therapy other than physiologic replacement (i.e. prednisone â‰¤ 10 mg or equivalent). Inhaled or topical steroid use is allowed.\n 6.  Active auto-immune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is allowed.\n 7.  Active colitis or previous immune-mediated colitis that has not resolved to grade 1 or less.\n 8.  Chemotherapy, targeted small molecule therapy, radiation therapy, hormonal treatment or immunotherapy within 21 days prior to initiation of treatment. A 6-week washout period will be required for those with prior PD-1 or PD-L1 treatment. Subjects must have resolution of toxic effect(s) of the most recent therapy to Grade 1 or less. Exceptions are subjects with â‰¤ Grade 2 alopecia or â‰¤ Grade 2 neuropathy who are permitted in the study. If the subject received major surgery or radiation therapy of >30 Gy, they must have recovered from the toxicity and/or any complications from the intervention.\n 9.  Pregnancy, breastfeeding, or expectation to conceive or father children within the projected duration of the trial, starting with the screening visit through 4 weeks after the last dose of study treatment.\n 10. Known sensitivity to any of the products or components to be administered during dosing.\n 11. Participation in a study of an investigational agent or device within 4 weeks of Day 1.\n 12. Subjects with any other concurrent, uncontrolled illness, including known psychiatric or substance abuse disorders which may interfere with the ability of the subject to cooperate and participate in the trial. Other examples of such conditions would include unstable angina, myocardial infarction (MI) or cerebrovascular accident (CVA) within 6 months of study entry.\n 13. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.\n 14. Patients with tumors lying close to an airway, major blood vessel or spinal cord that, in the opinion of the investigator, could cause occlusion or compression in the case of swelling, or erosion into a major vessel in the case of necrosis.",{"$nulls":4},"Actual","2018-01-24","Actual","Anticipated","2020-01-14","Anticipated","2019-04-01","2018-01-10","2018-01-23","2019-04-04",null,"CVA21\nCAVATAK\nCoxsackievirus\nocular\neye\nipilimumab\nyervoy\noncolytic\nvirus\ncheckpoint\nCTLA-4","Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No",null,null,"URL: https://www.viralytics.com/ [https://www.viralytics.com/] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: Viralytics website",null,"Yes","No",{"$nulls":19},"Incidence of treatment-related adverse events as assessed using the current NCI-CTCAE.","Treatment-emergent adverse events (TEAEs) are defined as AEs that start on or after the first day of study treatment and within 30 days of the last administration of study treatment. The incidence of TEAEs will be summarized based on the number and percentage of subjects who experience events classified by MedDRA system organ class and preferred term.","30 days from the last administration of study treatment","Overall Response Rate","Objective responses will be assessed according to immune-related Response Evaluation Criteria In Solid Tumors (irRECIST) criteria","2 years",{"$nulls":3},"Miami Beach, Florida, United States, 33140|Boston, Massachusetts, United States, 02114 Dana-Farber Cancer InstituteBoston, Massachusetts, United States, 02215","Florida|Massachusetts","United States","Mount Sinai Medical Center|Massachusetts General Hospital",{"$nulls":4},"2019-04-04","2020-05-25T16:38:19.893","2020-05-26T17:10:42.972","NCT03408587"]
["5ecbf47b307e3d1b1f8d9db3","NCT03408587","2019-05-28","Viralytics","VRACY","Active, not recruiting","CAVATAKÂ® and Ipilimumab in Uveal Melanoma Metastatic to the Liver (VLA-024 CLEVER) (CLEVER)","Cva-21|Ipilimumab","CD55 Inhibitor|CTLA4 Inhibitor","Yes","['Cva-21']","Yes","['CD55 Inhibitor']","Phase 1",1,10,"Anticipated","2018-01-29","2020-01-14",{"$nulls":5},"This is an open-label Phase 1b clinical study of ipilimumab in combination with intravenous CVA21 in subjects who have uveal melanoma metastatic to liver.","This is an open-label Phase 1b clinical study of ipilimumab in combination with intravenous CVA21 in subjects who have uveal melanoma metastatic to liver. Subjects will receive up to 8 cycles of CVA21 at a planned dose of 1 x 10e9 TCID50 per infusion, with the first cycle being a 28-day cycle consisting of an intravenous infusion on Days 1, 3, 5 and 8 and subsequent cycles every 21 days from Day 8.\n\nIpilimumab will be given by intravenous administration at a dose of 3mg/kg, for a maximum of 4 doses, given on Days 8, 29, 50 and 71. On days when both CVA21 and ipilimumab are given, CVA21 will be given first.\n\nSubjects will be monitored for treatment toxicity using the current version of CTCAE.","An Open-Label Phase 1b Clinical Study of Intravenous CAVATAKÂ® (Coxsackievirus A21, CVA21), in Combination With Ipilimumab in Subjects With Uveal Melanoma Metastatic to Liver (VLA-024 CLEVER)","VLA-024","Uveal Melanoma\nLiver Metastases","Noma|Melanoma","Mouth Diseases|Oncology Solid Tumor","Ear, Nose and Throat|Oncology","Experimental","CVA21 / Ipilimumab","Subjects will receive up to 8 cycles (Day 155) of intravenous CVA21 and 4 doses of ipilimumab (Days 8, 29, 50 and 71).","Biological","CVA21|Ipilimumab","Oncolytic virus|Fully human IgG1 monoclonal antibody that binds to the CTLA-4 receptor expressed on activated T cells.","CAVATAK, Coxsackievirus A21|Yervoy","CVA21 / Ipilimumab","\n\n 1.  Histologic or cytologically confirmed diagnosis of uveal melanoma with measurable disease (based on RECIST 1.1 criteria) in the liver (by CT, PET/CT or MRI) at the time of screening.\n 2.  Patients that have had prior treatment must show disease progression during or following the last treatment according to RECIST 1.1 criteria.\n 3.  Men and women â‰¥ 18 years of age.\n 4.  The subject has a life expectancy of greater than 12 weeks.\n 5.  The subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n 6.  Adequate organ function as defined by and obtained within 28 days of starting treatment: * Absolute neutrophil count â‰¥ 1,500 /mcl\n      * WBC â‰¥ 3.0 x 10e9/L\n      * Platelets â‰¥ 100,000 /mcl\n      * Hemoglobin â‰¥ 9 g/dL\n      * Creatinine â‰¤ 1.5 x ULN\n      * Albumin > 3 g/dL\n      * Total bilirubin â‰¤ 1.5 x ULN or direct bilirubin â‰¤ ULN for subjects with total bilirubin > 1.5 x ULN\n      * AST and ALT â‰¤ 5 x ULN\n      * INR or PT â‰¤ 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT and PTT are within therapeutic range of intended use of anticoagulants.\n      * aPTT â‰¤ 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT and PTT are within therapeutic range of intended use of anticoagulants.\n     \n     \n 7.  Prior therapy with an immune checkpoint inhibitor therapy is allowable. A 6-week washout period will be required for those with prior PD-1 or PD-L1 treatment.\n 8.  Female subjects of child-bearing potential must have a negative urine pregnancy test within 72 hours prior to receiving the first dose of study medication. If a urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n 9.  Female and Male subjects of childbearing potential must be willing to use an adequate method of contraception, starting with the first dose of study drug through 4 weeks after the last dose of study drug. Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.\n 10. The subject is capable of understanding and complying with protocol requirements.\n 11. The subject or the subject's legally acceptable representative provides written, informed consent prior to the initiation of any study procedures.\n\n","\n\n 1.  The subject is a candidate for surgery or loco-regional treatment with curative intent.\n 2.  Subjects with active (i.e. symptomatic or growing) central nervous system (CNS) metastases. Subjects with CNS metastases are eligible if the metastases have been treated with surgery and/or radiotherapy, the subject is off corticosteroids for at least 2 weeks and the subject is neurologically stable.\n 3.  Known additional malignancy that is progressing or requires active treatment. Exceptions include cutaneous squamous cell or basal cell carcinoma that has undergone potentially curative therapy or in-situ cervical cancer.\n 4.  Known history of Human Immunodeficiency Virus (HIV, HIV 1/2 antibodies), known active Hepatitis B (e.g. HBsAg reactive) or Hepatitis C (e.g. HCV RNA [qualitative] is detected).\n 5.  Current systemic steroid therapy other than physiologic replacement (i.e. prednisone â‰¤ 10 mg or equivalent). Inhaled or topical steroid use is allowed.\n 6.  Active auto-immune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is allowed.\n 7.  Active colitis or previous immune-mediated colitis that has not resolved to grade 1 or less.\n 8.  Chemotherapy, targeted small molecule therapy, radiation therapy, hormonal treatment or immunotherapy within 21 days prior to initiation of treatment. A 6-week washout period will be required for those with prior PD-1 or PD-L1 treatment. Subjects must have resolution of toxic effect(s) of the most recent therapy to Grade 1 or less. Exceptions are subjects with â‰¤ Grade 2 alopecia or â‰¤ Grade 2 neuropathy who are permitted in the study. If the subject received major surgery or radiation therapy of >30 Gy, they must have recovered from the toxicity and/or any complications from the intervention.\n 9.  Pregnancy, breastfeeding, or expectation to conceive or father children within the projected duration of the trial, starting with the screening visit through 4 weeks after the last dose of study treatment.\n 10. Known sensitivity to any of the products or components to be administered during dosing.\n 11. Participation in a study of an investigational agent or device within 4 weeks of Day 1.\n 12. Subjects with any other concurrent, uncontrolled illness, including known psychiatric or substance abuse disorders which may interfere with the ability of the subject to cooperate and participate in the trial. Other examples of such conditions would include unstable angina, myocardial infarction (MI) or cerebrovascular accident (CVA) within 6 months of study entry.\n 13. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.\n 14. Patients with tumors lying close to an airway, major blood vessel or spinal cord that, in the opinion of the investigator, could cause occlusion or compression in the case of swelling, or erosion into a major vessel in the case of necrosis.",{"$nulls":4},"Actual","2018-01-24","Actual","Anticipated","2020-01-14","Anticipated","2019-05-01","2018-01-10","2018-01-23","2019-05-23",null,"CVA21\nCAVATAK\nCoxsackievirus\nocular\neye\nipilimumab\nyervoy\noncolytic\nvirus\ncheckpoint\nCTLA-4","Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No",null,null,"URL: https://www.viralytics.com/ [https://www.viralytics.com/] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: Viralytics website",null,"Yes","No",{"$nulls":19},"Incidence of treatment-related adverse events as assessed using the current NCI-CTCAE.","Treatment-emergent adverse events (TEAEs) are defined as AEs that start on or after the first day of study treatment and within 30 days of the last administration of study treatment. The incidence of TEAEs will be summarized based on the number and percentage of subjects who experience events classified by MedDRA system organ class and preferred term.","30 days from the last administration of study treatment","Overall Response Rate","Objective responses will be assessed according to immune-related Response Evaluation Criteria In Solid Tumors (irRECIST) criteria","2 years",{"$nulls":3},"Miami Beach, Florida, United States, 33140|Boston, Massachusetts, United States, 02114 Dana-Farber Cancer InstituteBoston, Massachusetts, United States, 02215","Florida|Massachusetts","United States","Mount Sinai Medical Center|Massachusetts General Hospital",{"$nulls":4},"2019-05-23","2020-05-25T16:38:19.670","2020-05-26T17:10:42.972","NCT03408587"]
["5ecbf47efe30261b1a048326","NCT03409107","2018-03-02","GlaxoSmithKline","GSK","Not yet recruiting","Anemia Studies in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat in Non-Dialysis Subjects Evaluating Hemoglobin (Hgb) and Quality of Life (ASCEND-NHQ)","Daprodustat","HIF Inhibitor","Yes","['Daprodustat']","Yes","['HIF Inhibitor']","Phase 3",2,600,"Anticipated","2018-03-12","2020-11-12",{"$nulls":5},"The purpose of this multi-center study in non-dialysis subjects with anemia associated with CKD is to evaluate safety, efficacy and quality of life of daprodustat compared to placebo.",null,"A 28-week, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center, Study in Recombinant Human Erythropoietin (rhEPO) naÃ¯ve Non-dialysis Participants With Anemia Associated With Chronic Kidney Disease to Evaluate the Efficacy, Safety and Effects on Quality of Life of Daprodustat Compared to Placebo",205270,"Anaemia","Anemia|Hemoglobin C Disease|Hemoglobin SC Disease","Hematologic Diseases","Heme & Lymph Diseases","Experimental|Placebo Comparator","Daprodustat receivers|Placebo receivers","Subjects will receive oral daprodustat once daily|Subjects will receive oral placebo once daily","Drug","Daprodustat (GSK1278863)|Iron therapy|Placebo","Daprodustat will be available as 9 millimeter (mm) or 7 mm film-coated tablets. Daprodustat will be administered once daily via oral route and can be taken without regard to food.|Iron therapy will be administered if ferritin is <=50 Nano gram per milliliter and/or TSAT is <=15 percent.|Daprodustat matching placebo will be available as 9 mm or 7 mm film coated tablets. Placebo will be administered once daily via oral route and can be taken without regard to food.",null,"Daprodustat receivers|Placebo receivers","\n\n * >=18 years of age at the time of signing the informed consent.\n * Have CKD, confirmed at screening: Kidney Disease Outcomes Quality Initiative (KDOQI) CKD stages 3, 4, or 5 defined by Estimated glomerular filtration rate (eGFR) using the CKD Epidemiology Collaboration (CKD-EPI) formula.\n * Subjects with Stable HemoCue Hgb from 8.5 to 10.5 at screening visit (Week -4) and from 8.5 to 10.0 g/dL at randomization (Day 1).\n * Subjects may receive up to one intravenous (IV) iron dose within the 8 weeks prior to screening and NO IV iron use between screening visit and randomization (Day 1).\n * If needed, subject may be on stable maintenance oral iron supplementation. The type of iron and dose must not be changed for the 4 weeks prior to screening (Week -4), through the screening period, and until randomization (Day 1).\n * Male and female subjects are eligible. A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: Not a woman of childbearing potential (WOCBP) or WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 4 weeks after the last dose of study treatment.\n * Capable of giving signed informed consent.\n\n","\n\n * Subjects who are on dialysis or clinical evidence of impending need to initiate dialysis within 180 days after randomization (Day 1).\n * Planned living-related or living-unrelated kidney transplant within 28 weeks after randomization (Day 1).\n * Transferrin saturation (TSAT) <15 percent (Screening only).\n * Ferritin <50 nanograms per milliliter (ng/mL) (Screening only).\n * History of rhEPO or rhEPO analogue use within the 8 weeks prior to screening and rhEPO use between screening and randomization (Day 1).\n * History of transfusion within the 8 weeks prior to screening and transfusion between screening and randomization (Day 1).\n * History of bone marrow aplasia or pure red cell aplasia (PRCA).\n * Subjects with Megaloblastic anemia (untreated pernicious anemia and folate deficiency), thalassemia major, sickle cell disease or myelodysplastic syndrome.\n * Evidence of actively bleeding gastric, duodenal, or esophageal ulcer disease or clinically significant gastrointestinal (GI) bleeding <= 8 weeks prior to screening through to randomization (Day 1).\n * History of severe allergic or anaphylactic reactions or hypersensitivity to excipients in the investigational product.\n * Use of strong inhibitor of CYP2C8 (for example, gemfibrozil) or strong inducers of CYP2C8 (for example, rifampin/rifampicin).\n * Ferric citrate use within 4 weeks prior to randomization (Day 1).\n * Use of another investigational agent within 30 days or within five half-lives of the investigational agent (whichever is longer) or currently participating in a study of an investigational device prior to screening through to randomization (Day 1).\n * Any prior treatment with daprodustat for a treatment duration of >30 days.\n * MI or acute coronary syndrome within the 8 weeks prior to screening through to randomization. (Day 1).\n * Stroke or transient ischemic attack within the 8 weeks prior to screening through to randomization. (Day 1).\n * Chronic Class IV heart failure, as defined by the New York Heart Association (NYHA) functional classification system.\n * QT interval corrected by Bazett's formula (QTcB) >500 milliseconds (msec) or QTcB >530 msec in subjects with bundle branch block. There is no corrected QT interval (QTc) exclusion for subjects with a predominantly paced rhythm.\n * Alanine transaminase (ALT) >2x upper limit of normal (ULN) at screening (Week -4).\n * Bilirubin >1.5xULN at screening (Week -4).\n * Current unstable liver or biliary disease per investigator assessment, generally defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis.\n * History of malignancy within the 2 years prior to screening through to randomization (Day 1), or currently receiving treatment for cancer, or complex kidney cyst (for example, Bosniak Category II F, III or IV) > 3 centimeters (cm).\n * Any other condition, clinical or laboratory abnormality, or examination finding that the investigator considers would put the subject at unacceptable risk, which may affect study compliance or prevent understanding of the aims or investigational procedures or possible consequences of the study.","EGFR","epidermal growth factor receptor","Protein","Ovary, Breast, Lung","Actual","2018-01-24","Actual","Anticipated","2020-11-12","Anticipated","2018-03-01","2018-01-08","2018-01-17","2018-03-01","No","Non-Dialysis\nAnemia\nChronic kidney disease\nRecombinant human erythropoietin naÃ¯ve\nHemoglobin\nDaprodustat","Interventional","Treatment","Parallel Assignment","Double (Participant, Investigator)","Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":19},"Mean change from Baseline in Hgb up to evaluation period (EP)","The EP is from Week 24 to Week 28.","Baseline and up to Week 28","Number of subjects with Hgb increase of >=1.0 grams per deciliter (g/dL) from Baseline|Mean change from Baseline in short form-36 (SF-36) questionnaire vitality domain score|Incidences and severity of adverse events (AEs) and serious AEs (SAEs)|Number of Hgb responders|Mean change from Baseline for additional Hgb parameters|Time to rescue|Mean change from Baseline in CKD - Anemia Questionnaire (CKD-AQ) score|Change from Baseline in Patient Global Impression of Severity (PGI-S) score|Change from Baseline in work productivity and daily regular activity impairment|Change from Baseline in EuroQol 5 Dimension 5 Level Health Utility Index (EQ-5D-5L) score|Change from Baseline EuroQol Visual Analogue Scale (EQ-VAS) score","Number of subjects having a Hgb increase of >=1.0 g/dL from Baseline to EP.|Mean Change in SF-36 Vitality domain score between Baseline and Week 28.|Includes AEs of special interest and adjudicated Major adverse cardiovascular event (MACE) (composite of all-cause mortality, non-fatal Myocardial infarction|Responders will be defined as subjects whose mean Hgb is within target range.|Percentage time Hgb in range and mean change in Hgb from Baseline.|Rescue is defined as permanently stopping randomized treatment due to meeting rescue criteria.|Change from Baseline to week 28 by domain and overall symptom score.|Change from Baseline to Week 28 in symptom severity score.|Change for Baseline to week 28 in mean hours work time missed on the work productivity and activity impairment (WPAI-ANS-CPV) scale.|The EQ-5D-5L is a self-reported descriptive system of health-related quality of life states consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take one of five responses. The EQ-5D-5L score ranges from 1= no problem to 5= extreme problems. A unique health state is defined by combining score from each of the five dimensions.|The EQ-VAS is a part of EQ-5D-5L heath status. The EQ VAS records the self-rated health of a subject on a 20 cm vertical, visual analogue scale. The scale ranges from 0= 'the worst health you can imagine' to 100= 'the best health you can imagine'. This instrument can be used as a quantitative measure of health as judged by the individual.","Baseline and up to Week 28|Baseline and Week 28|MI and non-fatal stroke).|Up to Week 28","GSKClinicalSupportHD@gsk.com","US GSK Clinical Trials Call Center","877-379-3718","Waxahachie, Texas, United States, 75165","Texas","United States","Gsk Investigational Site",{"$nulls":3},"GSK Clinical Trials","2018-03-01","2020-05-25T16:38:22.294","2020-05-26T17:10:42.972","NCT03409107"]
["5ecbf47e307e3d1b1f8d9db8","NCT03409107","2018-03-06","GlaxoSmithKline","GSK","Not yet recruiting","Anemia Studies in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat in Non-Dialysis Subjects Evaluating Hemoglobin (Hgb) and Quality of Life (ASCEND-NHQ)","Daprodustat","HIF Inhibitor","Yes","['Daprodustat']","Yes","['HIF Inhibitor']","Phase 3",2,600,"Anticipated","2018-03-12","2020-11-12",{"$nulls":5},"The purpose of this multi-center study in non-dialysis subjects with anemia associated with CKD is to evaluate safety, efficacy and quality of life of daprodustat compared to placebo.",null,"A 28-week, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center, Study in Recombinant Human Erythropoietin (rhEPO) naÃ¯ve Non-dialysis Participants With Anemia Associated With Chronic Kidney Disease to Evaluate the Efficacy, Safety and Effects on Quality of Life of Daprodustat Compared to Placebo",205270,"Anaemia","Anemia|Hemoglobin C Disease|Hemoglobin SC Disease","Hematologic Diseases","Heme & Lymph Diseases","Experimental|Placebo Comparator","Daprodustat receivers|Placebo receivers","Subjects will receive oral daprodustat once daily|Subjects will receive oral placebo once daily","Drug","Daprodustat (GSK1278863)|Iron therapy|Placebo","Daprodustat will be available as 9 millimeter (mm) or 7 mm film-coated tablets. Daprodustat will be administered once daily via oral route and can be taken without regard to food.|Iron therapy will be administered if ferritin is <=50 Nano gram per milliliter and/or TSAT is <=15 percent.|Daprodustat matching placebo will be available as 9 mm or 7 mm film coated tablets. Placebo will be administered once daily via oral route and can be taken without regard to food.",null,"Daprodustat receivers|Placebo receivers","\n\n * >=18 years of age at the time of signing the informed consent.\n * Have CKD, confirmed at screening: Kidney Disease Outcomes Quality Initiative (KDOQI) CKD stages 3, 4, or 5 defined by Estimated glomerular filtration rate (eGFR) using the CKD Epidemiology Collaboration (CKD-EPI) formula.\n * Subjects with Stable HemoCue Hgb from 8.5 to 10.5 at screening visit (Week -4) and from 8.5 to 10.0 g/dL at randomization (Day 1).\n * Subjects may receive up to one intravenous (IV) iron dose within the 8 weeks prior to screening and NO IV iron use between screening visit and randomization (Day 1).\n * If needed, subject may be on stable maintenance oral iron supplementation. The type of iron and dose must not be changed for the 4 weeks prior to screening (Week -4), through the screening period, and until randomization (Day 1).\n * Male and female subjects are eligible. A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: Not a woman of childbearing potential (WOCBP) or WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 4 weeks after the last dose of study treatment.\n * Capable of giving signed informed consent.\n\n","\n\n * Subjects who are on dialysis or clinical evidence of impending need to initiate dialysis within 180 days after randomization (Day 1).\n * Planned living-related or living-unrelated kidney transplant within 28 weeks after randomization (Day 1).\n * Transferrin saturation (TSAT) <15 percent (Screening only).\n * Ferritin <50 nanograms per milliliter (ng/mL) (Screening only).\n * History of rhEPO or rhEPO analogue use within the 8 weeks prior to screening and rhEPO use between screening and randomization (Day 1).\n * History of transfusion within the 8 weeks prior to screening and transfusion between screening and randomization (Day 1).\n * History of bone marrow aplasia or pure red cell aplasia (PRCA).\n * Subjects with Megaloblastic anemia (untreated pernicious anemia and folate deficiency), thalassemia major, sickle cell disease or myelodysplastic syndrome.\n * Evidence of actively bleeding gastric, duodenal, or esophageal ulcer disease or clinically significant gastrointestinal (GI) bleeding <= 8 weeks prior to screening through to randomization (Day 1).\n * History of severe allergic or anaphylactic reactions or hypersensitivity to excipients in the investigational product.\n * Use of strong inhibitor of CYP2C8 (for example, gemfibrozil) or strong inducers of CYP2C8 (for example, rifampin/rifampicin).\n * Ferric citrate use within 4 weeks prior to randomization (Day 1).\n * Use of another investigational agent within 30 days or within five half-lives of the investigational agent (whichever is longer) or currently participating in a study of an investigational device prior to screening through to randomization (Day 1).\n * Any prior treatment with daprodustat for a treatment duration of >30 days.\n * MI or acute coronary syndrome within the 8 weeks prior to screening through to randomization. (Day 1).\n * Stroke or transient ischemic attack within the 8 weeks prior to screening through to randomization. (Day 1).\n * Chronic Class IV heart failure, as defined by the New York Heart Association (NYHA) functional classification system.\n * QT interval corrected by Bazett's formula (QTcB) >500 milliseconds (msec) or QTcB >530 msec in subjects with bundle branch block. There is no corrected QT interval (QTc) exclusion for subjects with a predominantly paced rhythm.\n * Alanine transaminase (ALT) >2x upper limit of normal (ULN) at screening (Week -4).\n * Bilirubin >1.5xULN at screening (Week -4).\n * Current unstable liver or biliary disease per investigator assessment, generally defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis.\n * History of malignancy within the 2 years prior to screening through to randomization (Day 1), or currently receiving treatment for cancer, or complex kidney cyst (for example, Bosniak Category II F, III or IV) > 3 centimeters (cm).\n * Any other condition, clinical or laboratory abnormality, or examination finding that the investigator considers would put the subject at unacceptable risk, which may affect study compliance or prevent understanding of the aims or investigational procedures or possible consequences of the study.","EGFR","epidermal growth factor receptor","Protein","Ovary, Breast, Lung","Actual","2018-01-24","Actual","Anticipated","2020-11-12","Anticipated","2018-03-01","2018-01-08","2018-01-17","2018-03-05","No","Non-Dialysis\nAnemia\nChronic kidney disease\nRecombinant human erythropoietin naÃ¯ve\nHemoglobin\nDaprodustat","Interventional","Treatment","Parallel Assignment","Double (Participant, Investigator)","Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":19},"Mean change from Baseline in Hgb up to evaluation period (EP)","The EP is from Week 24 to Week 28.","Baseline and up to Week 28","Number of subjects with Hgb increase of >=1.0 grams per deciliter (g/dL) from Baseline|Mean change from Baseline in short form-36 (SF-36) questionnaire vitality domain score|Incidences and severity of adverse events (AEs) and serious AEs (SAEs)|Number of Hgb responders|Mean change from Baseline for additional Hgb parameters|Time to rescue|Mean change from Baseline in CKD - Anemia Questionnaire (CKD-AQ) score|Change from Baseline in Patient Global Impression of Severity (PGI-S) score|Change from Baseline in work productivity and daily regular activity impairment|Change from Baseline in EuroQol 5 Dimension 5 Level Health Utility Index (EQ-5D-5L) score|Change from Baseline EuroQol Visual Analogue Scale (EQ-VAS) score","Number of subjects having a Hgb increase of >=1.0 g/dL from Baseline to EP.|Mean Change in SF-36 Vitality domain score between Baseline and Week 28.|Includes AEs of special interest and adjudicated Major adverse cardiovascular event (MACE) (composite of all-cause mortality, non-fatal Myocardial infarction|Responders will be defined as subjects whose mean Hgb is within target range.|Percentage time Hgb in range and mean change in Hgb from Baseline.|Rescue is defined as permanently stopping randomized treatment due to meeting rescue criteria.|Change from Baseline to week 28 by domain and overall symptom score.|Change from Baseline to Week 28 in symptom severity score.|Change for Baseline to week 28 in mean hours work time missed on the work productivity and activity impairment (WPAI-ANS-CPV) scale.|The EQ-5D-5L is a self-reported descriptive system of health-related quality of life states consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take one of five responses. The EQ-5D-5L score ranges from 1= no problem to 5= extreme problems. A unique health state is defined by combining score from each of the five dimensions.|The EQ-VAS is a part of EQ-5D-5L heath status. The EQ VAS records the self-rated health of a subject on a 20 cm vertical, visual analogue scale. The scale ranges from 0= 'the worst health you can imagine' to 100= 'the best health you can imagine'. This instrument can be used as a quantitative measure of health as judged by the individual.","Baseline and up to Week 28|Baseline and Week 28|MI and non-fatal stroke).|Up to Week 28","GSKClinicalSupportHD@gsk.com","US GSK Clinical Trials Call Center","877-379-3718","Waxahachie, Texas, United States, 75165","Texas","United States","Gsk Investigational Site",{"$nulls":3},"GSK Clinical Trials","2018-03-05","2020-05-25T16:38:22.885","2020-05-26T17:10:42.972","NCT03409107"]
["5ecbf47efeab101b15530956","NCT03409107","2018-03-30","GlaxoSmithKline","GSK","Recruiting","Anemia Studies in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat in Non-Dialysis Subjects Evaluating Hemoglobin (Hgb) and Quality of Life (ASCEND-NHQ)","Daprodustat","HIF Inhibitor","Yes","['Daprodustat']","Yes","['HIF Inhibitor']","Phase 3",2,600,"Anticipated","2018-03-05","2020-11-12",{"$nulls":5},"The purpose of this multi-center study in non-dialysis subjects with anemia associated with CKD is to evaluate safety, efficacy and quality of life of daprodustat compared to placebo.",null,"A 28-week, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center, Study in Recombinant Human Erythropoietin (rhEPO) naÃ¯ve Non-dialysis Participants With Anemia Associated With Chronic Kidney Disease to Evaluate the Efficacy, Safety and Effects on Quality of Life of Daprodustat Compared to Placebo",205270,"Anaemia","Anemia|Hemoglobin C Disease|Hemoglobin SC Disease","Hematologic Diseases","Heme & Lymph Diseases","Experimental|Placebo Comparator","Daprodustat receivers|Placebo receivers","Subjects will receive oral daprodustat once daily|Subjects will receive oral placebo once daily","Drug","Daprodustat (GSK1278863)|Iron therapy|Placebo","Daprodustat will be available as 9 millimeter (mm) or 7 mm film-coated tablets. Daprodustat will be administered once daily via oral route and can be taken without regard to food.|Iron therapy will be administered if ferritin is <=50 Nano gram per milliliter and/or TSAT is <=15 percent.|Daprodustat matching placebo will be available as 9 mm or 7 mm film coated tablets. Placebo will be administered once daily via oral route and can be taken without regard to food.",null,"Daprodustat receivers|Placebo receivers","\n\n * >=18 years of age at the time of signing the informed consent.\n * Have CKD, confirmed at screening: Kidney Disease Outcomes Quality Initiative (KDOQI) CKD stages 3, 4, or 5 defined by Estimated glomerular filtration rate (eGFR) using the CKD Epidemiology Collaboration (CKD-EPI) formula.\n * Subjects with Stable HemoCue Hgb from 8.5 to 10.5 at screening visit (Week -4) and from 8.5 to 10.0 g/dL at randomization (Day 1).\n * Subjects may receive up to one intravenous (IV) iron dose within the 8 weeks prior to screening and NO IV iron use between screening visit and randomization (Day 1).\n * If needed, subject may be on stable maintenance oral iron supplementation. The type of iron and dose must not be changed for the 4 weeks prior to screening (Week -4), through the screening period, and until randomization (Day 1).\n * Male and female subjects are eligible. A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: Not a woman of childbearing potential (WOCBP) or WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 4 weeks after the last dose of study treatment.\n * Capable of giving signed informed consent.\n\n","\n\n * Subjects who are on dialysis or clinical evidence of impending need to initiate dialysis within 180 days after randomization (Day 1).\n * Planned living-related or living-unrelated kidney transplant within 28 weeks after randomization (Day 1).\n * Transferrin saturation (TSAT) <15 percent (Screening only).\n * Ferritin <50 nanograms per milliliter (ng/mL) (Screening only).\n * History of rhEPO or rhEPO analogue use within the 8 weeks prior to screening and rhEPO use between screening and randomization (Day 1).\n * History of transfusion within the 8 weeks prior to screening and transfusion between screening and randomization (Day 1).\n * History of bone marrow aplasia or pure red cell aplasia (PRCA).\n * Subjects with Megaloblastic anemia (untreated pernicious anemia and folate deficiency), thalassemia major, sickle cell disease or myelodysplastic syndrome.\n * Evidence of actively bleeding gastric, duodenal, or esophageal ulcer disease or clinically significant gastrointestinal (GI) bleeding <= 8 weeks prior to screening through to randomization (Day 1).\n * History of severe allergic or anaphylactic reactions or hypersensitivity to excipients in the investigational product.\n * Use of strong inhibitor of CYP2C8 (for example, gemfibrozil) or strong inducers of CYP2C8 (for example, rifampin/rifampicin).\n * Ferric citrate use within 4 weeks prior to randomization (Day 1).\n * Use of another investigational agent within 30 days or within five half-lives of the investigational agent (whichever is longer) or currently participating in a study of an investigational device prior to screening through to randomization (Day 1).\n * Any prior treatment with daprodustat for a treatment duration of >30 days.\n * MI or acute coronary syndrome within the 8 weeks prior to screening through to randomization. (Day 1).\n * Stroke or transient ischemic attack within the 8 weeks prior to screening through to randomization. (Day 1).\n * Chronic Class IV heart failure, as defined by the New York Heart Association (NYHA) functional classification system.\n * QT interval corrected by Bazett's formula (QTcB) >500 milliseconds (msec) or QTcB >530 msec in subjects with bundle branch block. There is no corrected QT interval (QTc) exclusion for subjects with a predominantly paced rhythm.\n * Alanine transaminase (ALT) >2x upper limit of normal (ULN) at screening (Week -4).\n * Bilirubin >1.5xULN at screening (Week -4).\n * Current unstable liver or biliary disease per investigator assessment, generally defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis.\n * History of malignancy within the 2 years prior to screening through to randomization (Day 1), or currently receiving treatment for cancer, or complex kidney cyst (for example, Bosniak Category II F, III or IV) > 3 centimeters (cm).\n * Any other condition, clinical or laboratory abnormality, or examination finding that the investigator considers would put the subject at unacceptable risk, which may affect study compliance or prevent understanding of the aims or investigational procedures or possible consequences of the study.","EGFR","epidermal growth factor receptor","Protein","Ovary, Breast, Lung","Actual","2018-01-24","Actual","Anticipated","2020-11-12","Anticipated","2018-03-01","2018-01-08","2018-01-17","2018-03-29","No","Non-Dialysis\nAnemia\nChronic kidney disease\nRecombinant human erythropoietin naÃ¯ve\nHemoglobin\nDaprodustat","Interventional","Treatment","Parallel Assignment","Double (Participant, Investigator)","Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":19},"Mean change from Baseline in Hgb up to evaluation period (EP)","The EP is from Week 24 to Week 28.","Baseline and up to Week 28","Number of subjects with Hgb increase of >=1.0 grams per deciliter (g/dL) from Baseline|Mean change from Baseline in short form-36 (SF-36) questionnaire vitality domain score|Incidences and severity of adverse events (AEs) and serious AEs (SAEs)|Number of Hgb responders|Mean change from Baseline for additional Hgb parameters|Time to rescue|Mean change from Baseline in CKD - Anemia Questionnaire (CKD-AQ) score|Change from Baseline in Patient Global Impression of Severity (PGI-S) score|Change from Baseline in work productivity and daily regular activity impairment|Change from Baseline in EuroQol 5 Dimension 5 Level Health Utility Index (EQ-5D-5L) score|Change from Baseline EuroQol Visual Analogue Scale (EQ-VAS) score","Number of subjects having a Hgb increase of >=1.0 g/dL from Baseline to EP.|Mean Change in SF-36 Vitality domain score between Baseline and Week 28.|Includes AEs of special interest and adjudicated Major adverse cardiovascular event (MACE) (composite of all-cause mortality, non-fatal Myocardial infarction|Responders will be defined as subjects whose mean Hgb is within target range.|Percentage time Hgb in range and mean change in Hgb from Baseline.|Rescue is defined as permanently stopping randomized treatment due to meeting rescue criteria.|Change from Baseline to week 28 by domain and overall symptom score.|Change from Baseline to Week 28 in symptom severity score.|Change for Baseline to week 28 in mean hours work time missed on the work productivity and activity impairment (WPAI-ANS-CPV) scale.|The EQ-5D-5L is a self-reported descriptive system of health-related quality of life states consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take one of five responses. The EQ-5D-5L score ranges from 1= no problem to 5= extreme problems. A unique health state is defined by combining score from each of the five dimensions.|The EQ-VAS is a part of EQ-5D-5L heath status. The EQ VAS records the self-rated health of a subject on a 20 cm vertical, visual analogue scale. The scale ranges from 0= 'the worst health you can imagine' to 100= 'the best health you can imagine'. This instrument can be used as a quantitative measure of health as judged by the individual.","Baseline and up to Week 28|Baseline and Week 28|MI and non-fatal stroke).|Up to Week 28","GSKClinicalSupportHD@gsk.com","US GSK Clinical Trials Call Center","877-379-3718","Brampton, Ontario, Canada, L6T 0G1|Peterborough, United Kingdom, Pe3 9Gz|Hollywood, Florida, United States, 33024|Macon, Georgia, United States, 31217|Buckley, Michigan, United States, 49620|Waxahachie, Texas, United States, 75165","Florida|Georgia|Michigan|Texas","Canada|United Kingdom|United States","Ontario Gsk Investigational Site|Gsk Investigational Site",{"$nulls":3},"GSK Clinical Trials","2018-03-29","2020-05-25T16:38:22.972","2020-05-26T17:10:42.972","NCT03409107"]
["5ecbf47ffeab101b15530957","NCT03409107","2018-04-06","GlaxoSmithKline","GSK","Recruiting","Anemia Studies in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat in Non-Dialysis Subjects Evaluating Hemoglobin (Hgb) and Quality of Life (ASCEND-NHQ)","Daprodustat","HIF Inhibitor","Yes","['Daprodustat']","Yes","['HIF Inhibitor']","Phase 3",2,600,"Anticipated","2018-03-05","2020-11-12",{"$nulls":5},"The purpose of this multi-center study in non-dialysis subjects with anemia associated with CKD is to evaluate safety, efficacy and quality of life of daprodustat compared to placebo.",null,"A 28-week, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center, Study in Recombinant Human Erythropoietin (rhEPO) naÃ¯ve Non-dialysis Participants With Anemia Associated With Chronic Kidney Disease to Evaluate the Efficacy, Safety and Effects on Quality of Life of Daprodustat Compared to Placebo",205270,"Anaemia","Anemia|Hemoglobin C Disease|Hemoglobin SC Disease","Hematologic Diseases","Heme & Lymph Diseases","Experimental|Placebo Comparator","Daprodustat receivers|Placebo receivers","Subjects will receive oral daprodustat once daily|Subjects will receive oral placebo once daily","Drug","Daprodustat (GSK1278863)|Iron therapy|Placebo","Daprodustat will be available as 9 millimeter (mm) or 7 mm film-coated tablets. Daprodustat will be administered once daily via oral route and can be taken without regard to food.|Iron therapy will be administered if ferritin is <=50 Nano gram per milliliter and/or TSAT is <=15 percent.|Daprodustat matching placebo will be available as 9 mm or 7 mm film coated tablets. Placebo will be administered once daily via oral route and can be taken without regard to food.",null,"Daprodustat receivers|Placebo receivers","\n\n * >=18 years of age at the time of signing the informed consent.\n * Have CKD, confirmed at screening: Kidney Disease Outcomes Quality Initiative (KDOQI) CKD stages 3, 4, or 5 defined by Estimated glomerular filtration rate (eGFR) using the CKD Epidemiology Collaboration (CKD-EPI) formula.\n * Subjects with Stable HemoCue Hgb from 8.5 to 10.5 at screening visit (Week -4) and from 8.5 to 10.0 g/dL at randomization (Day 1).\n * Subjects may receive up to one intravenous (IV) iron dose within the 8 weeks prior to screening and NO IV iron use between screening visit and randomization (Day 1).\n * If needed, subject may be on stable maintenance oral iron supplementation. The type of iron and dose must not be changed for the 4 weeks prior to screening (Week -4), through the screening period, and until randomization (Day 1).\n * Male and female subjects are eligible. A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: Not a woman of childbearing potential (WOCBP) or WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 4 weeks after the last dose of study treatment.\n * Capable of giving signed informed consent.\n\n","\n\n * Subjects who are on dialysis or clinical evidence of impending need to initiate dialysis within 180 days after randomization (Day 1).\n * Planned living-related or living-unrelated kidney transplant within 28 weeks after randomization (Day 1).\n * Transferrin saturation (TSAT) <15 percent (Screening only).\n * Ferritin <50 nanograms per milliliter (ng/mL) (Screening only).\n * History of rhEPO or rhEPO analogue use within the 8 weeks prior to screening and rhEPO use between screening and randomization (Day 1).\n * History of transfusion within the 8 weeks prior to screening and transfusion between screening and randomization (Day 1).\n * History of bone marrow aplasia or pure red cell aplasia (PRCA).\n * Subjects with Megaloblastic anemia (untreated pernicious anemia and folate deficiency), thalassemia major, sickle cell disease or myelodysplastic syndrome.\n * Evidence of actively bleeding gastric, duodenal, or esophageal ulcer disease or clinically significant gastrointestinal (GI) bleeding <= 8 weeks prior to screening through to randomization (Day 1).\n * History of severe allergic or anaphylactic reactions or hypersensitivity to excipients in the investigational product.\n * Use of strong inhibitor of CYP2C8 (for example, gemfibrozil) or strong inducers of CYP2C8 (for example, rifampin/rifampicin).\n * Ferric citrate use within 4 weeks prior to randomization (Day 1).\n * Use of another investigational agent within 30 days or within five half-lives of the investigational agent (whichever is longer) or currently participating in a study of an investigational device prior to screening through to randomization (Day 1).\n * Any prior treatment with daprodustat for a treatment duration of >30 days.\n * MI or acute coronary syndrome within the 8 weeks prior to screening through to randomization. (Day 1).\n * Stroke or transient ischemic attack within the 8 weeks prior to screening through to randomization. (Day 1).\n * Chronic Class IV heart failure, as defined by the New York Heart Association (NYHA) functional classification system.\n * QT interval corrected by Bazett's formula (QTcB) >500 milliseconds (msec) or QTcB >530 msec in subjects with bundle branch block. There is no corrected QT interval (QTc) exclusion for subjects with a predominantly paced rhythm.\n * Alanine transaminase (ALT) >2x upper limit of normal (ULN) at screening (Week -4).\n * Bilirubin >1.5xULN at screening (Week -4).\n * Current unstable liver or biliary disease per investigator assessment, generally defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis.\n * History of malignancy within the 2 years prior to screening through to randomization (Day 1), or currently receiving treatment for cancer, or complex kidney cyst (for example, Bosniak Category II F, III or IV) > 3 centimeters (cm).\n * Any other condition, clinical or laboratory abnormality, or examination finding that the investigator considers would put the subject at unacceptable risk, which may affect study compliance or prevent understanding of the aims or investigational procedures or possible consequences of the study.","EGFR","epidermal growth factor receptor","Protein","Ovary, Breast, Lung","Actual","2018-01-24","Actual","Anticipated","2020-11-12","Anticipated","2018-04-01","2018-01-08","2018-01-17","2018-04-05","No","Non-Dialysis\nAnemia\nChronic kidney disease\nRecombinant human erythropoietin naÃ¯ve\nHemoglobin\nDaprodustat","Interventional","Treatment","Parallel Assignment","Double (Participant, Investigator)","Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":19},"Mean change from Baseline in Hgb up to evaluation period (EP)","The EP is from Week 24 to Week 28.","Baseline and up to Week 28","Number of subjects with Hgb increase of >=1.0 grams per deciliter (g/dL) from Baseline|Mean change from Baseline in short form-36 (SF-36) questionnaire vitality domain score|Incidences and severity of adverse events (AEs) and serious AEs (SAEs)|Number of Hgb responders|Mean change from Baseline for additional Hgb parameters|Time to rescue|Mean change from Baseline in CKD - Anemia Questionnaire (CKD-AQ) score|Change from Baseline in Patient Global Impression of Severity (PGI-S) score|Change from Baseline in work productivity and daily regular activity impairment|Change from Baseline in EuroQol 5 Dimension 5 Level Health Utility Index (EQ-5D-5L) score|Change from Baseline EuroQol Visual Analogue Scale (EQ-VAS) score","Number of subjects having a Hgb increase of >=1.0 g/dL from Baseline to EP.|Mean Change in SF-36 Vitality domain score between Baseline and Week 28.|Includes AEs of special interest and adjudicated Major adverse cardiovascular event (MACE) (composite of all-cause mortality, non-fatal Myocardial infarction|Responders will be defined as subjects whose mean Hgb is within target range.|Percentage time Hgb in range and mean change in Hgb from Baseline.|Rescue is defined as permanently stopping randomized treatment due to meeting rescue criteria.|Change from Baseline to week 28 by domain and overall symptom score.|Change from Baseline to Week 28 in symptom severity score.|Change for Baseline to week 28 in mean hours work time missed on the work productivity and activity impairment (WPAI-ANS-CPV) scale.|The EQ-5D-5L is a self-reported descriptive system of health-related quality of life states consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take one of five responses. The EQ-5D-5L score ranges from 1= no problem to 5= extreme problems. A unique health state is defined by combining score from each of the five dimensions.|The EQ-VAS is a part of EQ-5D-5L heath status. The EQ VAS records the self-rated health of a subject on a 20 cm vertical, visual analogue scale. The scale ranges from 0= 'the worst health you can imagine' to 100= 'the best health you can imagine'. This instrument can be used as a quantitative measure of health as judged by the individual.","Baseline and up to Week 28|Baseline and Week 28|MI and non-fatal stroke).|Up to Week 28","GSKClinicalSupportHD@gsk.com","US GSK Clinical Trials Call Center","877-379-3718","Brampton, Ontario, Canada, L6T 0G1|Santiago De Compostela, Spain|Peterborough, United Kingdom, Pe3 9Gz|Northridge, California, United States, 91325|Hollywood, Florida, United States, 33024|Macon, Georgia, United States, 31217|Buckley, Michigan, United States, 49620|Waxahachie, Texas, United States, 75165","California|Florida|Georgia|Michigan|Texas","Canada|Spain|United Kingdom|United States","Ontario Gsk Investigational Site|Gsk Investigational Site",{"$nulls":3},"GSK Clinical Trials","2018-04-05","2020-05-25T16:38:23.380","2020-05-26T17:10:42.972","NCT03409107"]
["5ecbf47ffe30261b1a048328","NCT03409107","2018-04-17","GlaxoSmithKline","GSK","Recruiting","Anemia Studies in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat in Non-Dialysis Subjects Evaluating Hemoglobin (Hgb) and Quality of Life (ASCEND-NHQ)","Daprodustat","HIF Inhibitor","Yes","['Daprodustat']","Yes","['HIF Inhibitor']","Phase 3",2,600,"Anticipated","2018-03-05","2020-11-12",{"$nulls":5},"The purpose of this multi-center study in non-dialysis subjects with anemia associated with CKD is to evaluate safety, efficacy and quality of life of daprodustat compared to placebo.",null,"A 28-week, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center, Study in Recombinant Human Erythropoietin (rhEPO) naÃ¯ve Non-dialysis Participants With Anemia Associated With Chronic Kidney Disease to Evaluate the Efficacy, Safety and Effects on Quality of Life of Daprodustat Compared to Placebo",205270,"Anaemia","Anemia|Hemoglobin C Disease|Hemoglobin SC Disease","Hematologic Diseases","Heme & Lymph Diseases","Experimental|Placebo Comparator","Daprodustat receivers|Placebo receivers","Subjects will receive oral daprodustat once daily|Subjects will receive oral placebo once daily","Drug","Daprodustat (GSK1278863)|Iron therapy|Placebo","Daprodustat will be available as 9 millimeter (mm) or 7 mm film-coated tablets. Daprodustat will be administered once daily via oral route and can be taken without regard to food.|Iron therapy will be administered if ferritin is <=50 Nano gram per milliliter and/or TSAT is <=15 percent.|Daprodustat matching placebo will be available as 9 mm or 7 mm film coated tablets. Placebo will be administered once daily via oral route and can be taken without regard to food.",null,"Daprodustat receivers|Placebo receivers","\n\n * >=18 years of age at the time of signing the informed consent.\n * Have CKD, confirmed at screening: Kidney Disease Outcomes Quality Initiative (KDOQI) CKD stages 3, 4, or 5 defined by Estimated glomerular filtration rate (eGFR) using the CKD Epidemiology Collaboration (CKD-EPI) formula.\n * Subjects with Stable HemoCue Hgb from 8.5 to 10.5 at screening visit (Week -4) and from 8.5 to 10.0 g/dL at randomization (Day 1).\n * Subjects may receive up to one intravenous (IV) iron dose within the 8 weeks prior to screening and NO IV iron use between screening visit and randomization (Day 1).\n * If needed, subject may be on stable maintenance oral iron supplementation. The type of iron and dose must not be changed for the 4 weeks prior to screening (Week -4), through the screening period, and until randomization (Day 1).\n * Male and female subjects are eligible. A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: Not a woman of childbearing potential (WOCBP) or WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 4 weeks after the last dose of study treatment.\n * Capable of giving signed informed consent.\n\n","\n\n * Subjects who are on dialysis or clinical evidence of impending need to initiate dialysis within 180 days after randomization (Day 1).\n * Planned living-related or living-unrelated kidney transplant within 28 weeks after randomization (Day 1).\n * Transferrin saturation (TSAT) <15 percent (Screening only).\n * Ferritin <50 nanograms per milliliter (ng/mL) (Screening only).\n * History of rhEPO or rhEPO analogue use within the 8 weeks prior to screening and rhEPO use between screening and randomization (Day 1).\n * History of transfusion within the 8 weeks prior to screening and transfusion between screening and randomization (Day 1).\n * History of bone marrow aplasia or pure red cell aplasia (PRCA).\n * Subjects with Megaloblastic anemia (untreated pernicious anemia and folate deficiency), thalassemia major, sickle cell disease or myelodysplastic syndrome.\n * Evidence of actively bleeding gastric, duodenal, or esophageal ulcer disease or clinically significant gastrointestinal (GI) bleeding <= 8 weeks prior to screening through to randomization (Day 1).\n * History of severe allergic or anaphylactic reactions or hypersensitivity to excipients in the investigational product.\n * Use of strong inhibitor of CYP2C8 (for example, gemfibrozil) or strong inducers of CYP2C8 (for example, rifampin/rifampicin).\n * Ferric citrate use within 4 weeks prior to randomization (Day 1).\n * Use of another investigational agent within 30 days or within five half-lives of the investigational agent (whichever is longer) or currently participating in a study of an investigational device prior to screening through to randomization (Day 1).\n * Any prior treatment with daprodustat for a treatment duration of >30 days.\n * MI or acute coronary syndrome within the 8 weeks prior to screening through to randomization. (Day 1).\n * Stroke or transient ischemic attack within the 8 weeks prior to screening through to randomization. (Day 1).\n * Chronic Class IV heart failure, as defined by the New York Heart Association (NYHA) functional classification system.\n * QT interval corrected by Bazett's formula (QTcB) >500 milliseconds (msec) or QTcB >530 msec in subjects with bundle branch block. There is no corrected QT interval (QTc) exclusion for subjects with a predominantly paced rhythm.\n * Alanine transaminase (ALT) >2x upper limit of normal (ULN) at screening (Week -4).\n * Bilirubin >1.5xULN at screening (Week -4).\n * Current unstable liver or biliary disease per investigator assessment, generally defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis.\n * History of malignancy within the 2 years prior to screening through to randomization (Day 1), or currently receiving treatment for cancer, or complex kidney cyst (for example, Bosniak Category II F, III or IV) > 3 centimeters (cm).\n * Any other condition, clinical or laboratory abnormality, or examination finding that the investigator considers would put the subject at unacceptable risk, which may affect study compliance or prevent understanding of the aims or investigational procedures or possible consequences of the study.","EGFR","epidermal growth factor receptor","Protein","Ovary, Breast, Lung","Actual","2018-01-24","Actual","Anticipated","2020-11-12","Anticipated","2018-04-01","2018-01-08","2018-01-17","2018-04-16","No","Non-Dialysis\nAnemia\nChronic kidney disease\nRecombinant human erythropoietin naÃ¯ve\nHemoglobin\nDaprodustat","Interventional","Treatment","Parallel Assignment","Double (Participant, Investigator)","Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":19},"Mean change from Baseline in Hgb up to evaluation period (EP)","The EP is from Week 24 to Week 28.","Baseline and up to Week 28","Number of subjects with Hgb increase of >=1.0 grams per deciliter (g/dL) from Baseline|Mean change from Baseline in short form-36 (SF-36) questionnaire vitality domain score|Incidences and severity of adverse events (AEs) and serious AEs (SAEs)|Number of Hgb responders|Mean change from Baseline for additional Hgb parameters|Time to rescue|Mean change from Baseline in CKD - Anemia Questionnaire (CKD-AQ) score|Change from Baseline in Patient Global Impression of Severity (PGI-S) score|Change from Baseline in work productivity and daily regular activity impairment|Change from Baseline in EuroQol 5 Dimension 5 Level Health Utility Index (EQ-5D-5L) score|Change from Baseline EuroQol Visual Analogue Scale (EQ-VAS) score","Number of subjects having a Hgb increase of >=1.0 g/dL from Baseline to EP.|Mean Change in SF-36 Vitality domain score between Baseline and Week 28.|Includes AEs of special interest and adjudicated Major adverse cardiovascular event (MACE) (composite of all-cause mortality, non-fatal Myocardial infarction|Responders will be defined as subjects whose mean Hgb is within target range.|Percentage time Hgb in range and mean change in Hgb from Baseline.|Rescue is defined as permanently stopping randomized treatment due to meeting rescue criteria.|Change from Baseline to week 28 by domain and overall symptom score.|Change from Baseline to Week 28 in symptom severity score.|Change for Baseline to week 28 in mean hours work time missed on the work productivity and activity impairment (WPAI-ANS-CPV) scale.|The EQ-5D-5L is a self-reported descriptive system of health-related quality of life states consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take one of five responses. The EQ-5D-5L score ranges from 1= no problem to 5= extreme problems. A unique health state is defined by combining score from each of the five dimensions.|The EQ-VAS is a part of EQ-5D-5L heath status. The EQ VAS records the self-rated health of a subject on a 20 cm vertical, visual analogue scale. The scale ranges from 0= 'the worst health you can imagine' to 100= 'the best health you can imagine'. This instrument can be used as a quantitative measure of health as judged by the individual.","Baseline and up to Week 28|Baseline and Week 28|MI and non-fatal stroke).|Up to Week 28","GSKClinicalSupportHD@gsk.com","US GSK Clinical Trials Call Center","877-379-3718","Victoria, British Columbia, Canada, V8V 4A1|Brampton, Ontario, Canada, L6T 0G1|Grenoble Cedex 9, France, 38043|Badalona, Spain, 08916|Peterborough, United Kingdom, Pe3 9Gz|Northridge, California, United States, 91325|Hollywood, Florida, United States, 33024|Macon, Georgia, United States, 31217|Buckley, Michigan, United States, 49620|Charlotte, North Carolina, United States, 28262|Oklahoma City, Oklahoma, United States, 73112|Waxahachie, Texas, United States, 75165","California|Florida|Georgia|Michigan|North Carolina|Oklahoma|Texas","Canada|France|Spain|United Kingdom|United States","British Columbia Gsk Investigational Site|Ontario Gsk Investigational Site|Gsk Investigational Site",{"$nulls":3},"GSK Clinical Trials","2018-04-16","2020-05-25T16:38:23.244","2020-05-26T17:10:42.972","NCT03409107"]
["5ecbf47f307e3d1b1f8d9dba","NCT03409107","2018-04-27","GlaxoSmithKline","GSK","Recruiting","Anemia Studies in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat in Non-Dialysis Subjects Evaluating Hemoglobin (Hgb) and Quality of Life (ASCEND-NHQ)","Daprodustat","HIF Inhibitor","Yes","['Daprodustat']","Yes","['HIF Inhibitor']","Phase 3",2,600,"Anticipated","2018-03-05","2020-11-12",{"$nulls":5},"The purpose of this multi-center study in non-dialysis subjects with anemia associated with CKD is to evaluate safety, efficacy and quality of life of daprodustat compared to placebo.",null,"A 28-week, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center, Study in Recombinant Human Erythropoietin (rhEPO) naÃ¯ve Non-dialysis Participants With Anemia Associated With Chronic Kidney Disease to Evaluate the Efficacy, Safety and Effects on Quality of Life of Daprodustat Compared to Placebo",205270,"Anaemia","Anemia|Hemoglobin C Disease|Hemoglobin SC Disease","Hematologic Diseases","Heme & Lymph Diseases","Experimental|Placebo Comparator","Daprodustat receivers|Placebo receivers","Subjects will receive oral daprodustat once daily|Subjects will receive oral placebo once daily","Drug","Daprodustat (GSK1278863)|Iron therapy|Placebo","Daprodustat will be available as 9 millimeter (mm) or 7 mm film-coated tablets. Daprodustat will be administered once daily via oral route and can be taken without regard to food.|Iron therapy will be administered if ferritin is <=50 Nano gram per milliliter and/or TSAT is <=15 percent.|Daprodustat matching placebo will be available as 9 mm or 7 mm film coated tablets. Placebo will be administered once daily via oral route and can be taken without regard to food.",null,"Daprodustat receivers|Placebo receivers","\n\n * >=18 years of age at the time of signing the informed consent.\n * Have CKD, confirmed at screening: Kidney Disease Outcomes Quality Initiative (KDOQI) CKD stages 3, 4, or 5 defined by Estimated glomerular filtration rate (eGFR) using the CKD Epidemiology Collaboration (CKD-EPI) formula.\n * Subjects with Stable HemoCue Hgb from 8.5 to 10.5 at screening visit (Week -4) and from 8.5 to 10.0 g/dL at randomization (Day 1).\n * Subjects may receive up to one intravenous (IV) iron dose within the 8 weeks prior to screening and NO IV iron use between screening visit and randomization (Day 1).\n * If needed, subject may be on stable maintenance oral iron supplementation. The type of iron and dose must not be changed for the 4 weeks prior to screening (Week -4), through the screening period, and until randomization (Day 1).\n * Male and female subjects are eligible. A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: Not a woman of childbearing potential (WOCBP) or WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 4 weeks after the last dose of study treatment.\n * Capable of giving signed informed consent.\n\n","\n\n * Subjects who are on dialysis or clinical evidence of impending need to initiate dialysis within 180 days after randomization (Day 1).\n * Planned living-related or living-unrelated kidney transplant within 28 weeks after randomization (Day 1).\n * Transferrin saturation (TSAT) <15 percent (Screening only).\n * Ferritin <50 nanograms per milliliter (ng/mL) (Screening only).\n * History of rhEPO or rhEPO analogue use within the 8 weeks prior to screening and rhEPO use between screening and randomization (Day 1).\n * History of transfusion within the 8 weeks prior to screening and transfusion between screening and randomization (Day 1).\n * History of bone marrow aplasia or pure red cell aplasia (PRCA).\n * Subjects with Megaloblastic anemia (untreated pernicious anemia and folate deficiency), thalassemia major, sickle cell disease or myelodysplastic syndrome.\n * Evidence of actively bleeding gastric, duodenal, or esophageal ulcer disease or clinically significant gastrointestinal (GI) bleeding <= 8 weeks prior to screening through to randomization (Day 1).\n * History of severe allergic or anaphylactic reactions or hypersensitivity to excipients in the investigational product.\n * Use of strong inhibitor of CYP2C8 (for example, gemfibrozil) or strong inducers of CYP2C8 (for example, rifampin/rifampicin).\n * Ferric citrate use within 4 weeks prior to randomization (Day 1).\n * Use of another investigational agent within 30 days or within five half-lives of the investigational agent (whichever is longer) or currently participating in a study of an investigational device prior to screening through to randomization (Day 1).\n * Any prior treatment with daprodustat for a treatment duration of >30 days.\n * MI or acute coronary syndrome within the 8 weeks prior to screening through to randomization. (Day 1).\n * Stroke or transient ischemic attack within the 8 weeks prior to screening through to randomization. (Day 1).\n * Chronic Class IV heart failure, as defined by the New York Heart Association (NYHA) functional classification system.\n * QT interval corrected by Bazett's formula (QTcB) >500 milliseconds (msec) or QTcB >530 msec in subjects with bundle branch block. There is no corrected QT interval (QTc) exclusion for subjects with a predominantly paced rhythm.\n * Alanine transaminase (ALT) >2x upper limit of normal (ULN) at screening (Week -4).\n * Bilirubin >1.5xULN at screening (Week -4).\n * Current unstable liver or biliary disease per investigator assessment, generally defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis.\n * History of malignancy within the 2 years prior to screening through to randomization (Day 1), or currently receiving treatment for cancer, or complex kidney cyst (for example, Bosniak Category II F, III or IV) > 3 centimeters (cm).\n * Any other condition, clinical or laboratory abnormality, or examination finding that the investigator considers would put the subject at unacceptable risk, which may affect study compliance or prevent understanding of the aims or investigational procedures or possible consequences of the study.","EGFR","epidermal growth factor receptor","Protein","Ovary, Breast, Lung","Actual","2018-01-24","Actual","Anticipated","2020-11-12","Anticipated","2018-04-01","2018-01-08","2018-01-17","2018-04-26","No","Non-Dialysis\nAnemia\nChronic kidney disease\nRecombinant human erythropoietin naÃ¯ve\nHemoglobin\nDaprodustat","Interventional","Treatment","Parallel Assignment","Double (Participant, Investigator)","Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":19},"Mean change from Baseline in Hgb up to evaluation period (EP)","The EP is from Week 24 to Week 28.","Baseline and up to Week 28","Number of subjects with Hgb increase of >=1.0 grams per deciliter (g/dL) from Baseline|Mean change from Baseline in short form-36 (SF-36) questionnaire vitality domain score|Incidences and severity of adverse events (AEs) and serious AEs (SAEs)|Number of Hgb responders|Mean change from Baseline for additional Hgb parameters|Time to rescue|Mean change from Baseline in CKD - Anemia Questionnaire (CKD-AQ) score|Change from Baseline in Patient Global Impression of Severity (PGI-S) score|Change from Baseline in work productivity and daily regular activity impairment|Change from Baseline in EuroQol 5 Dimension 5 Level Health Utility Index (EQ-5D-5L) score|Change from Baseline EuroQol Visual Analogue Scale (EQ-VAS) score","Number of subjects having a Hgb increase of >=1.0 g/dL from Baseline to EP.|Mean Change in SF-36 Vitality domain score between Baseline and Week 28.|Includes AEs of special interest and adjudicated Major adverse cardiovascular event (MACE) (composite of all-cause mortality, non-fatal Myocardial infarction|Responders will be defined as subjects whose mean Hgb is within target range.|Percentage time Hgb in range and mean change in Hgb from Baseline.|Rescue is defined as permanently stopping randomized treatment due to meeting rescue criteria.|Change from Baseline to week 28 by domain and overall symptom score.|Change from Baseline to Week 28 in symptom severity score.|Change for Baseline to week 28 in mean hours work time missed on the work productivity and activity impairment (WPAI-ANS-CPV) scale.|The EQ-5D-5L is a self-reported descriptive system of health-related quality of life states consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take one of five responses. The EQ-5D-5L score ranges from 1= no problem to 5= extreme problems. A unique health state is defined by combining score from each of the five dimensions.|The EQ-VAS is a part of EQ-5D-5L heath status. The EQ VAS records the self-rated health of a subject on a 20 cm vertical, visual analogue scale. The scale ranges from 0= 'the worst health you can imagine' to 100= 'the best health you can imagine'. This instrument can be used as a quantitative measure of health as judged by the individual.","Baseline and up to Week 28|Baseline and Week 28|MI and non-fatal stroke).|Up to Week 28","GSKClinicalSupportHD@gsk.com","US GSK Clinical Trials Call Center","877-379-3718","Sydney, New South Wales, Australia, 2010|Victoria, British Columbia, Canada, V8V 4A1|Brampton, Ontario, Canada, L6T 0G1|Grenoble Cedex 9, France, 38043|Badalona, Spain, 08916|Peterborough, United Kingdom, Pe3 9Gz|Northridge, California, United States, 91325|Hollywood, Florida, United States, 33021-5424|Macon, Georgia, United States, 31217|Buckley, Michigan, United States, 49620|Charlotte, North Carolina, United States, 28262|Oklahoma City, Oklahoma, United States, 73112|Waxahachie, Texas, United States, 75165","California|Florida|Georgia|Michigan|North Carolina|Oklahoma|Texas","Australia|Canada|France|Spain|United Kingdom|United States","New South Wales Gsk Investigational Site|British Columbia Gsk Investigational Site|Ontario Gsk Investigational Site|Gsk Investigational Site",{"$nulls":3},"GSK Clinical Trials","2018-04-26","2020-05-25T16:38:23.762","2020-05-26T17:10:42.972","NCT03409107"]
["5ecbf47ffe30261b1a048329","NCT03409107","2018-05-04","GlaxoSmithKline","GSK","Recruiting","Anemia Studies in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat in Non-Dialysis Subjects Evaluating Hemoglobin (Hgb) and Quality of Life (ASCEND-NHQ)","Daprodustat","HIF Inhibitor","Yes","['Daprodustat']","Yes","['HIF Inhibitor']","Phase 3",2,600,"Anticipated","2018-03-05","2020-11-12",{"$nulls":5},"The purpose of this multi-center study in non-dialysis subjects with anemia associated with CKD is to evaluate safety, efficacy and quality of life of daprodustat compared to placebo.",null,"A 28-week, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center, Study in Recombinant Human Erythropoietin (rhEPO) naÃ¯ve Non-dialysis Participants With Anemia Associated With Chronic Kidney Disease to Evaluate the Efficacy, Safety and Effects on Quality of Life of Daprodustat Compared to Placebo",205270,"Anaemia","Anemia|Hemoglobin C Disease|Hemoglobin SC Disease","Hematologic Diseases","Heme & Lymph Diseases","Experimental|Placebo Comparator","Daprodustat receivers|Placebo receivers","Subjects will receive oral daprodustat once daily|Subjects will receive oral placebo once daily","Drug","Daprodustat (GSK1278863)|Iron therapy|Placebo","Daprodustat will be available as 9 millimeter (mm) or 7 mm film-coated tablets. Daprodustat will be administered once daily via oral route and can be taken without regard to food.|Iron therapy will be administered if ferritin is <=50 Nano gram per milliliter and/or TSAT is <=15 percent.|Daprodustat matching placebo will be available as 9 mm or 7 mm film coated tablets. Placebo will be administered once daily via oral route and can be taken without regard to food.",null,"Daprodustat receivers|Placebo receivers","\n\n * >=18 years of age at the time of signing the informed consent.\n * Have CKD, confirmed at screening: Kidney Disease Outcomes Quality Initiative (KDOQI) CKD stages 3, 4, or 5 defined by Estimated glomerular filtration rate (eGFR) using the CKD Epidemiology Collaboration (CKD-EPI) formula.\n * Subjects with Stable HemoCue Hgb from 8.5 to 10.5 at screening visit (Week -4) and from 8.5 to 10.0 g/dL at randomization (Day 1).\n * Subjects may receive up to one intravenous (IV) iron dose within the 8 weeks prior to screening and NO IV iron use between screening visit and randomization (Day 1).\n * If needed, subject may be on stable maintenance oral iron supplementation. The type of iron and dose must not be changed for the 4 weeks prior to screening (Week -4), through the screening period, and until randomization (Day 1).\n * Male and female subjects are eligible. A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: Not a woman of childbearing potential (WOCBP) or WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 4 weeks after the last dose of study treatment.\n * Capable of giving signed informed consent.\n\n","\n\n * Subjects who are on dialysis or clinical evidence of impending need to initiate dialysis within 180 days after randomization (Day 1).\n * Planned living-related or living-unrelated kidney transplant within 28 weeks after randomization (Day 1).\n * Transferrin saturation (TSAT) <15 percent (Screening only).\n * Ferritin <50 nanograms per milliliter (ng/mL) (Screening only).\n * History of rhEPO or rhEPO analogue use within the 8 weeks prior to screening and rhEPO use between screening and randomization (Day 1).\n * History of transfusion within the 8 weeks prior to screening and transfusion between screening and randomization (Day 1).\n * History of bone marrow aplasia or pure red cell aplasia (PRCA).\n * Subjects with Megaloblastic anemia (untreated pernicious anemia and folate deficiency), thalassemia major, sickle cell disease or myelodysplastic syndrome.\n * Evidence of actively bleeding gastric, duodenal, or esophageal ulcer disease or clinically significant gastrointestinal (GI) bleeding <= 8 weeks prior to screening through to randomization (Day 1).\n * History of severe allergic or anaphylactic reactions or hypersensitivity to excipients in the investigational product.\n * Use of strong inhibitor of CYP2C8 (for example, gemfibrozil) or strong inducers of CYP2C8 (for example, rifampin/rifampicin).\n * Ferric citrate use within 4 weeks prior to randomization (Day 1).\n * Use of another investigational agent within 30 days or within five half-lives of the investigational agent (whichever is longer) or currently participating in a study of an investigational device prior to screening through to randomization (Day 1).\n * Any prior treatment with daprodustat for a treatment duration of >30 days.\n * MI or acute coronary syndrome within the 8 weeks prior to screening through to randomization. (Day 1).\n * Stroke or transient ischemic attack within the 8 weeks prior to screening through to randomization. (Day 1).\n * Chronic Class IV heart failure, as defined by the New York Heart Association (NYHA) functional classification system.\n * QT interval corrected by Bazett's formula (QTcB) >500 milliseconds (msec) or QTcB >530 msec in subjects with bundle branch block. There is no corrected QT interval (QTc) exclusion for subjects with a predominantly paced rhythm.\n * Alanine transaminase (ALT) >2x upper limit of normal (ULN) at screening (Week -4).\n * Bilirubin >1.5xULN at screening (Week -4).\n * Current unstable liver or biliary disease per investigator assessment, generally defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis.\n * History of malignancy within the 2 years prior to screening through to randomization (Day 1), or currently receiving treatment for cancer, or complex kidney cyst (for example, Bosniak Category II F, III or IV) > 3 centimeters (cm).\n * Any other condition, clinical or laboratory abnormality, or examination finding that the investigator considers would put the subject at unacceptable risk, which may affect study compliance or prevent understanding of the aims or investigational procedures or possible consequences of the study.","EGFR","epidermal growth factor receptor","Protein","Ovary, Breast, Lung","Actual","2018-01-24","Actual","Anticipated","2020-11-12","Anticipated","2018-05-01","2018-01-08","2018-01-17","2018-05-03","No","Non-Dialysis\nAnemia\nChronic kidney disease\nRecombinant human erythropoietin naÃ¯ve\nHemoglobin\nDaprodustat","Interventional","Treatment","Parallel Assignment","Double (Participant, Investigator)","Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":19},"Mean change from Baseline in Hgb up to evaluation period (EP)","The EP is from Week 24 to Week 28.","Baseline and up to Week 28","Number of subjects with Hgb increase of >=1.0 grams per deciliter (g/dL) from Baseline|Mean change from Baseline in short form-36 (SF-36) questionnaire vitality domain score|Incidences and severity of adverse events (AEs) and serious AEs (SAEs)|Number of Hgb responders|Mean change from Baseline for additional Hgb parameters|Time to rescue|Mean change from Baseline in CKD - Anemia Questionnaire (CKD-AQ) score|Change from Baseline in Patient Global Impression of Severity (PGI-S) score|Change from Baseline in work productivity and daily regular activity impairment|Change from Baseline in EuroQol 5 Dimension 5 Level Health Utility Index (EQ-5D-5L) score|Change from Baseline EuroQol Visual Analogue Scale (EQ-VAS) score","Number of subjects having a Hgb increase of >=1.0 g/dL from Baseline to EP.|Mean Change in SF-36 Vitality domain score between Baseline and Week 28.|Includes AEs of special interest and adjudicated Major adverse cardiovascular event (MACE) (composite of all-cause mortality, non-fatal Myocardial infarction|Responders will be defined as subjects whose mean Hgb is within target range.|Percentage time Hgb in range and mean change in Hgb from Baseline.|Rescue is defined as permanently stopping randomized treatment due to meeting rescue criteria.|Change from Baseline to week 28 by domain and overall symptom score.|Change from Baseline to Week 28 in symptom severity score.|Change for Baseline to week 28 in mean hours work time missed on the work productivity and activity impairment (WPAI-ANS-CPV) scale.|The EQ-5D-5L is a self-reported descriptive system of health-related quality of life states consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take one of five responses. The EQ-5D-5L score ranges from 1= no problem to 5= extreme problems. A unique health state is defined by combining score from each of the five dimensions.|The EQ-VAS is a part of EQ-5D-5L heath status. The EQ VAS records the self-rated health of a subject on a 20 cm vertical, visual analogue scale. The scale ranges from 0= 'the worst health you can imagine' to 100= 'the best health you can imagine'. This instrument can be used as a quantitative measure of health as judged by the individual.","Baseline and up to Week 28|Baseline and Week 28|MI and non-fatal stroke).|Up to Week 28","GSKClinicalSupportHD@gsk.com","US GSK Clinical Trials Call Center","877-379-3718","Sydney, New South Wales, Australia, 2010|Victoria, British Columbia, Canada, V8V 4A1|Brampton, Ontario, Canada, L6T 0G1|Grenoble Cedex 9, France, 38043|Swidnik, Poland, 21-040|Badalona, Spain, 08916|Peterborough, United Kingdom, Pe3 9Gz|Northridge, California, United States, 91325|Hollywood, Florida, United States, 33021-5424|Macon, Georgia, United States, 31217|Buckley, Michigan, United States, 49620|Charlotte, North Carolina, United States, 28262|Oklahoma City, Oklahoma, United States, 73112|San Antonio, Texas, United States, 78229","California|Florida|Georgia|Michigan|North Carolina|Oklahoma|Texas","Australia|Canada|France|Poland|Spain|United Kingdom|United States","New South Wales Gsk Investigational Site|British Columbia Gsk Investigational Site|Ontario Gsk Investigational Site|Gsk Investigational Site",{"$nulls":3},"GSK Clinical Trials","2018-05-03","2020-05-25T16:38:23.722","2020-05-26T17:10:42.972","NCT03409107"]
["5ecbf48211702c1b1b916b37","NCT03409107","2018-07-17","GlaxoSmithKline","GSK","Recruiting","Anemia Studies in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat in Non-Dialysis Subjects Evaluating Hemoglobin (Hgb) and Quality of Life (ASCEND-NHQ)","Daprodustat","HIF Inhibitor","Yes","['Daprodustat']","Yes","['HIF Inhibitor']","Phase 3",2,600,"Anticipated","2018-03-05","2020-11-05",{"$nulls":5},"The purpose of this multi-center study in non-dialysis subjects with anemia associated with CKD is to evaluate safety, efficacy and quality of life of daprodustat compared to placebo.",null,"A 28-week, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center, Study in Recombinant Human Erythropoietin (rhEPO) naÃ¯ve Non-dialysis Participants With Anemia Associated With Chronic Kidney Disease to Evaluate the Efficacy, Safety and Effects on Quality of Life of Daprodustat Compared to Placebo",205270,"Anaemia","Anemia|Hemoglobin C Disease|Hemoglobin SC Disease","Hematologic Diseases","Heme & Lymph Diseases","Experimental|Placebo Comparator","Daprodustat receivers|Placebo receivers","Subjects will receive oral daprodustat once daily|Subjects will receive oral placebo once daily","Drug","Daprodustat (GSK1278863)|Iron therapy|Placebo","Daprodustat will be available as 9 millimeter (mm) or 7 mm film-coated tablets. Daprodustat will be administered once daily via oral route and can be taken without regard to food.|Iron therapy will be administered if ferritin is <=50 Nano gram per milliliter and/or TSAT is <=15 percent.|Daprodustat matching placebo will be available as 9 mm or 7 mm film coated tablets. Placebo will be administered once daily via oral route and can be taken without regard to food.",null,"Daprodustat receivers|Placebo receivers","\n\n * >=18 years of age at the time of signing the informed consent.\n * Have CKD, confirmed at screening: Kidney Disease Outcomes Quality Initiative (KDOQI) CKD stages 3, 4, or 5 defined by Estimated glomerular filtration rate (eGFR) using the CKD Epidemiology Collaboration (CKD-EPI) formula.\n * Subjects with Stable HemoCue Hgb from 8.5 to 10.5 at screening visit (Week -4) and from 8.5 to 10.0 g/dL at randomization (Day 1).\n * Subjects may receive up to one intravenous (IV) iron dose within the 8 weeks prior to screening and NO IV iron use between screening visit and randomization (Day 1).\n * If needed, subject may be on stable maintenance oral iron supplementation. The type of iron and dose must not be changed for the 4 weeks prior to screening (Week -4), through the screening period, and until randomization (Day 1).\n * Male and female subjects are eligible. A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: Not a woman of childbearing potential (WOCBP) or WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 4 weeks after the last dose of study treatment.\n * Capable of giving signed informed consent.\n\n","\n\n * Subjects who are on dialysis or clinical evidence of impending need to initiate dialysis within 180 days after randomization (Day 1).\n * Planned living-related or living-unrelated kidney transplant within 28 weeks after randomization (Day 1).\n * Transferrin saturation (TSAT) <15 percent (Screening only).\n * Ferritin <50 nanograms per milliliter (ng/mL) (Screening only).\n * History of rhEPO or rhEPO analogue use within the 8 weeks prior to screening and rhEPO use between screening and randomization (Day 1).\n * History of transfusion within the 8 weeks prior to screening and transfusion between screening and randomization (Day 1).\n * History of bone marrow aplasia or pure red cell aplasia (PRCA).\n * Subjects with Megaloblastic anemia (untreated pernicious anemia and folate deficiency), thalassemia major, sickle cell disease or myelodysplastic syndrome.\n * Evidence of actively bleeding gastric, duodenal, or esophageal ulcer disease or clinically significant gastrointestinal (GI) bleeding <= 8 weeks prior to screening through to randomization (Day 1).\n * History of severe allergic or anaphylactic reactions or hypersensitivity to excipients in the investigational product.\n * Use of strong inhibitor of CYP2C8 (for example, gemfibrozil) or strong inducers of CYP2C8 (for example, rifampin/rifampicin).\n * Ferric citrate use within 4 weeks prior to randomization (Day 1).\n * Use of another investigational agent within 30 days or within five half-lives of the investigational agent (whichever is longer) or currently participating in a study of an investigational device prior to screening through to randomization (Day 1).\n * Any prior treatment with daprodustat for a treatment duration of >30 days.\n * MI or acute coronary syndrome within the 8 weeks prior to screening through to randomization. (Day 1).\n * Stroke or transient ischemic attack within the 8 weeks prior to screening through to randomization. (Day 1).\n * Chronic Class IV heart failure, as defined by the New York Heart Association (NYHA) functional classification system.\n * QT interval corrected by Bazett's formula (QTcB) >500 milliseconds (msec) or QTcB >530 msec in subjects with bundle branch block. There is no corrected QT interval (QTc) exclusion for subjects with a predominantly paced rhythm.\n * Alanine transaminase (ALT) >2x upper limit of normal (ULN) at screening (Week -4).\n * Bilirubin >1.5xULN at screening (Week -4).\n * Current unstable liver or biliary disease per investigator assessment, generally defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis.\n * History of malignancy within the 2 years prior to screening through to randomization (Day 1), or currently receiving treatment for cancer, or complex kidney cyst (for example, Bosniak Category II F, III or IV) > 3 centimeters (cm).\n * Any other condition, clinical or laboratory abnormality, or examination finding that the investigator considers would put the subject at unacceptable risk, which may affect study compliance or prevent understanding of the aims or investigational procedures or possible consequences of the study.","EGFR","epidermal growth factor receptor","Protein","Ovary, Breast, Lung","Actual","2018-01-24","Actual","Anticipated","2020-11-05","Anticipated","2018-07-01","2018-01-08","2018-01-17","2018-07-13","No","Non-Dialysis\nAnemia\nChronic kidney disease\nRecombinant human erythropoietin naÃ¯ve\nHemoglobin\nDaprodustat","Interventional","Treatment","Parallel Assignment","Double (Participant, Investigator)","Randomized","18 Years",null,"All",null,"No","Yes\nIPD for this study will be made available via the Clinical Study Data Request site.",{"$nulls":3},"Yes","No",{"$nulls":19},"Mean change from Baseline in Hgb up to evaluation period (EP)","The EP is from Week 24 to Week 28.","Baseline and up to Week 28","Number of subjects with Hgb increase of >=1.0 grams per deciliter (g/dL) from Baseline|Mean change from Baseline in short form-36 (SF-36) questionnaire vitality domain score|Incidences and severity of adverse events (AEs) and serious AEs (SAEs)|Number of Hgb responders|Mean change from Baseline for additional Hgb parameters|Time to rescue|Mean change from Baseline in CKD - Anemia Questionnaire (CKD-AQ) score|Change from Baseline in Patient Global Impression of Severity (PGI-S) score|Change from Baseline in work productivity and daily regular activity impairment|Change from Baseline in EuroQol 5 Dimension 5 Level Health Utility Index (EQ-5D-5L) score|Change from Baseline EuroQol Visual Analogue Scale (EQ-VAS) score","Number of subjects having a Hgb increase of >=1.0 g/dL from Baseline to EP.|Mean Change in SF-36 Vitality domain score between Baseline and Week 28.|Includes AEs of special interest and adjudicated Major adverse cardiovascular event (MACE) (composite of all-cause mortality, non-fatal Myocardial infarction|Responders will be defined as subjects whose mean Hgb is within target range.|Percentage time Hgb in range and mean change in Hgb from Baseline.|Rescue is defined as permanently stopping randomized treatment due to meeting rescue criteria.|Change from Baseline to week 28 by domain and overall symptom score.|Change from Baseline to Week 28 in symptom severity score.|Change for Baseline to week 28 in mean hours work time missed on the work productivity and activity impairment (WPAI-ANS-CPV) scale.|The EQ-5D-5L is a self-reported descriptive system of health-related quality of life states consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take one of five responses. The EQ-5D-5L score ranges from 1= no problem to 5= extreme problems. A unique health state is defined by combining score from each of the five dimensions.|The EQ-VAS is a part of EQ-5D-5L heath status. The EQ VAS records the self-rated health of a subject on a 20 cm vertical, visual analogue scale. The scale ranges from 0= 'the worst health you can imagine' to 100= 'the best health you can imagine'. This instrument can be used as a quantitative measure of health as judged by the individual.","Baseline and up to Week 28|Baseline and Week 28|MI and non-fatal stroke).|Up to Week 28","GSKClinicalSupportHD@gsk.com","US GSK Clinical Trials Call Center","877-379-3718","Ciudad Autonoma De Buenos Aires, Buenos Aires, Argentina, C1128Aaf|Sydney, New South Wales, Australia, 2010|Heidelberg, Victoria, Australia, 3084|Victoria, British Columbia, Canada, V8V 4A1|Brampton, Ontario, Canada, L6T 0G1|Grenoble Cedex 9, France, 38043|Pavia, Lombardia, Italy, 27100|Ciechanow, Poland, 06-400|Badalona, Spain, 08916|Canterbury, Kent, United Kingdom, Ct1 3Ng|Peterborough, United Kingdom, Pe3 9Gz|Homewood, Alabama, United States, 35209|Little Rock, Arkansas, United States, 72204|Fresno, California, United States, 93720|Middlebury, Connecticut, United States, 06762|Hollywood, Florida, United States, 33021-5424|Macon, Georgia, United States, 31217|Buckley, Michigan, United States, 49620|Saint Louis, Missouri, United States, 63136|Portsmouth, New Hampshire, United States, 03801|Asheville, North Carolina, United States, 28801|Oklahoma City, Oklahoma, United States, 73112|Beaver, Pennsylvania, United States, 15009|Orangeburg, South Carolina, United States, 29118|Desoto, Texas, United States, 75115|Norfolk, Virginia, United States, 23502","Alabama|Arkansas|California|Connecticut|Florida|Georgia|Michigan|Missouri|New Hampshire|North Carolina|Oklahoma|Pennsylvania|South Carolina|Texas|Virginia","Argentina|Australia|Canada|France|Italy|Poland|Spain|United Kingdom|United States","Buenos Aires Gsk Investigational Site|New South Wales Gsk Investigational Site|Victoria Gsk Investigational Site|British Columbia Gsk Investigational Site|Ontario Gsk Investigational Site|Gsk Investigational Site|Lombardia Gsk Investigational Site|, Kent Gsk Investigational Site",{"$nulls":3},"GSK Clinical Trials","2018-07-13","2020-05-25T16:38:26.556","2020-05-26T17:10:42.972","NCT03409107"]
["5ecbf482307e3d1b1f8d9dbb","NCT03409107","2018-08-03","GlaxoSmithKline","GSK","Recruiting","Anemia Studies in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat in Non-Dialysis Subjects Evaluating Hemoglobin (Hgb) and Quality of Life (ASCEND-NHQ)","Daprodustat","HIF Inhibitor","Yes","['Daprodustat']","Yes","['HIF Inhibitor']","Phase 3",2,600,"Anticipated","2018-03-05","2020-11-05",{"$nulls":5},"The purpose of this multi-center study in non-dialysis subjects with anemia associated with CKD is to evaluate safety, efficacy and quality of life of daprodustat compared to placebo.",null,"A 28-week, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center, Study in Recombinant Human Erythropoietin (rhEPO) naÃ¯ve Non-dialysis Participants With Anemia Associated With Chronic Kidney Disease to Evaluate the Efficacy, Safety and Effects on Quality of Life of Daprodustat Compared to Placebo",205270,"Anaemia","Anemia|Hemoglobin C Disease|Hemoglobin SC Disease","Hematologic Diseases","Heme & Lymph Diseases","Experimental|Placebo Comparator","Daprodustat receivers|Placebo receivers","Subjects will receive oral daprodustat once daily|Subjects will receive oral placebo once daily","Drug","Daprodustat (GSK1278863)|Iron therapy|Placebo","Daprodustat will be available as 9 millimeter (mm) or 7 mm film-coated tablets. Daprodustat will be administered once daily via oral route and can be taken without regard to food.|Iron therapy will be administered if ferritin is <=50 Nano gram per milliliter and/or TSAT is <=15 percent.|Daprodustat matching placebo will be available as 9 mm or 7 mm film coated tablets. Placebo will be administered once daily via oral route and can be taken without regard to food.",null,"Daprodustat receivers|Placebo receivers","\n\n * >=18 years of age at the time of signing the informed consent.\n * Have CKD, confirmed at screening: Kidney Disease Outcomes Quality Initiative (KDOQI) CKD stages 3, 4, or 5 defined by Estimated glomerular filtration rate (eGFR) using the CKD Epidemiology Collaboration (CKD-EPI) formula.\n * Subjects with Stable HemoCue Hgb from 8.5 to 10.5 at screening visit (Week -4) and from 8.5 to 10.0 g/dL at randomization (Day 1).\n * Subjects may receive up to one intravenous (IV) iron dose within the 8 weeks prior to screening and NO IV iron use between screening visit and randomization (Day 1).\n * If needed, subject may be on stable maintenance oral iron supplementation. The type of iron and dose must not be changed for the 4 weeks prior to screening (Week -4), through the screening period, and until randomization (Day 1).\n * Male and female subjects are eligible. A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: Not a woman of childbearing potential (WOCBP) or WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 4 weeks after the last dose of study treatment.\n * Capable of giving signed informed consent.\n\n","\n\n * Subjects who are on dialysis or clinical evidence of impending need to initiate dialysis within 180 days after randomization (Day 1).\n * Planned living-related or living-unrelated kidney transplant within 28 weeks after randomization (Day 1).\n * Transferrin saturation (TSAT) <15 percent (Screening only).\n * Ferritin <50 nanograms per milliliter (ng/mL) (Screening only).\n * History of rhEPO or rhEPO analogue use within the 8 weeks prior to screening and rhEPO use between screening and randomization (Day 1).\n * History of transfusion within the 8 weeks prior to screening and transfusion between screening and randomization (Day 1).\n * History of bone marrow aplasia or pure red cell aplasia (PRCA).\n * Subjects with Megaloblastic anemia (untreated pernicious anemia and folate deficiency), thalassemia major, sickle cell disease or myelodysplastic syndrome.\n * Evidence of actively bleeding gastric, duodenal, or esophageal ulcer disease or clinically significant gastrointestinal (GI) bleeding <= 8 weeks prior to screening through to randomization (Day 1).\n * History of severe allergic or anaphylactic reactions or hypersensitivity to excipients in the investigational product.\n * Use of strong inhibitor of CYP2C8 (for example, gemfibrozil) or strong inducers of CYP2C8 (for example, rifampin/rifampicin).\n * Ferric citrate use within 4 weeks prior to randomization (Day 1).\n * Use of another investigational agent within 30 days or within five half-lives of the investigational agent (whichever is longer) or currently participating in a study of an investigational device prior to screening through to randomization (Day 1).\n * Any prior treatment with daprodustat for a treatment duration of >30 days.\n * MI or acute coronary syndrome within the 8 weeks prior to screening through to randomization. (Day 1).\n * Stroke or transient ischemic attack within the 8 weeks prior to screening through to randomization. (Day 1).\n * Chronic Class IV heart failure, as defined by the New York Heart Association (NYHA) functional classification system.\n * QT interval corrected by Bazett's formula (QTcB) >500 milliseconds (msec) or QTcB >530 msec in subjects with bundle branch block. There is no corrected QT interval (QTc) exclusion for subjects with a predominantly paced rhythm.\n * Alanine transaminase (ALT) >2x upper limit of normal (ULN) at screening (Week -4).\n * Bilirubin >1.5xULN at screening (Week -4).\n * Current unstable liver or biliary disease per investigator assessment, generally defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis.\n * History of malignancy within the 2 years prior to screening through to randomization (Day 1), or currently receiving treatment for cancer, or complex kidney cyst (for example, Bosniak Category II F, III or IV) > 3 centimeters (cm).\n * Any other condition, clinical or laboratory abnormality, or examination finding that the investigator considers would put the subject at unacceptable risk, which may affect study compliance or prevent understanding of the aims or investigational procedures or possible consequences of the study.","EGFR","epidermal growth factor receptor","Protein","Ovary, Breast, Lung","Actual","2018-01-24","Actual","Anticipated","2020-11-05","Anticipated","2018-08-01","2018-01-08","2018-01-17","2018-08-02","No","Non-Dialysis\nAnemia\nChronic kidney disease\nRecombinant human erythropoietin naÃ¯ve\nHemoglobin\nDaprodustat","Interventional","Treatment","Parallel Assignment","Double (Participant, Investigator)","Randomized","18 Years",null,"All",null,"No","Yes\nIPD for this study will be made available via the Clinical Study Data Request site.",{"$nulls":3},"Yes","No",{"$nulls":19},"Mean change from Baseline in Hgb up to evaluation period (EP)","The EP is from Week 24 to Week 28.","Baseline and up to Week 28","Number of subjects with Hgb increase of >=1.0 grams per deciliter (g/dL) from Baseline|Mean change from Baseline in short form-36 (SF-36) questionnaire vitality domain score|Incidences and severity of adverse events (AEs) and serious AEs (SAEs)|Number of Hgb responders|Mean change from Baseline for additional Hgb parameters|Time to rescue|Mean change from Baseline in CKD - Anemia Questionnaire (CKD-AQ) score|Change from Baseline in Patient Global Impression of Severity (PGI-S) score|Change from Baseline in work productivity and daily regular activity impairment|Change from Baseline in EuroQol 5 Dimension 5 Level Health Utility Index (EQ-5D-5L) score|Change from Baseline EuroQol Visual Analogue Scale (EQ-VAS) score","Number of subjects having a Hgb increase of >=1.0 g/dL from Baseline to EP.|Mean Change in SF-36 Vitality domain score between Baseline and Week 28.|Includes AEs of special interest and adjudicated Major adverse cardiovascular event (MACE) (composite of all-cause mortality, non-fatal Myocardial infarction|Responders will be defined as subjects whose mean Hgb is within target range.|Percentage time Hgb in range and mean change in Hgb from Baseline.|Rescue is defined as permanently stopping randomized treatment due to meeting rescue criteria.|Change from Baseline to week 28 by domain and overall symptom score.|Change from Baseline to Week 28 in symptom severity score.|Change for Baseline to week 28 in mean hours work time missed on the work productivity and activity impairment (WPAI-ANS-CPV) scale.|The EQ-5D-5L is a self-reported descriptive system of health-related quality of life states consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take one of five responses. The EQ-5D-5L score ranges from 1= no problem to 5= extreme problems. A unique health state is defined by combining score from each of the five dimensions.|The EQ-VAS is a part of EQ-5D-5L heath status. The EQ VAS records the self-rated health of a subject on a 20 cm vertical, visual analogue scale. The scale ranges from 0= 'the worst health you can imagine' to 100= 'the best health you can imagine'. This instrument can be used as a quantitative measure of health as judged by the individual.","Baseline and up to Week 28|Baseline and Week 28|MI and non-fatal stroke).|Up to Week 28","GSKClinicalSupportHD@gsk.com","US GSK Clinical Trials Call Center","877-379-3718","Ciudad Autonoma De Buenos Aires, Buenos Aires, Argentina, C1128Aaf|Sydney, New South Wales, Australia, 2010|Heidelberg, Victoria, Australia, 3084|Victoria, British Columbia, Canada, V8V 4A1|Brampton, Ontario, Canada, L6T 0G1|Grenoble Cedex 9, France, 38043|Catanzaro, Calabria, Italy, 88100|Pavia, Lombardia, Italy, 27100|Merida, Mexico, 97000|Merida, YucatÃ¡n, Mexico, 97070|Ciechanow, Poland, 06-400|Badalona, Spain, 08916|Canterbury, Kent, United Kingdom, Ct1 3Ng|Peterborough, United Kingdom, Pe3 9Gz|Homewood, Alabama, United States, 35209|Little Rock, Arkansas, United States, 72204|Fresno, California, United States, 93720|Middlebury, Connecticut, United States, 06762|Hollywood, Florida, United States, 33021-5424|Macon, Georgia, United States, 31217|Buckley, Michigan, United States, 49620|Saint Louis, Missouri, United States, 63136|Portsmouth, New Hampshire, United States, 03801|Asheville, North Carolina, United States, 28801|Oklahoma City, Oklahoma, United States, 73112|Beaver, Pennsylvania, United States, 15009|Orangeburg, South Carolina, United States, 29118|Desoto, Texas, United States, 75115|Norfolk, Virginia, United States, 23502","Alabama|Arkansas|California|Connecticut|Florida|Georgia|Michigan|Missouri|New Hampshire|North Carolina|Oklahoma|Pennsylvania|South Carolina|Texas|Virginia","Argentina|Australia|Canada|France|Italy|Mexico|Poland|Spain|United Kingdom|United States","Buenos Aires Gsk Investigational Site|New South Wales Gsk Investigational Site|Victoria Gsk Investigational Site|British Columbia Gsk Investigational Site|Ontario Gsk Investigational Site|Gsk Investigational Site|Calabria Gsk Investigational Site|Lombardia Gsk Investigational Site|YucatÃ¡n Gsk Investigational Site|, Kent Gsk Investigational Site",{"$nulls":3},"GSK Clinical Trials","2018-08-02","2020-05-25T16:38:26.811","2020-05-26T17:10:42.972","NCT03409107"]
["5ecbf482e2561b1b11905e25","NCT03409107","2018-08-07","GlaxoSmithKline","GSK","Recruiting","Anemia Studies in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat in Non-Dialysis Subjects Evaluating Hemoglobin (Hgb) and Quality of Life (ASCEND-NHQ)","Daprodustat","HIF Inhibitor","Yes","['Daprodustat']","Yes","['HIF Inhibitor']","Phase 3",2,600,"Anticipated","2018-03-05","2020-11-05",{"$nulls":5},"The purpose of this multi-center study in non-dialysis subjects with anemia associated with CKD is to evaluate safety, efficacy and quality of life of daprodustat compared to placebo.",null,"A 28-week, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center, Study in Recombinant Human Erythropoietin (rhEPO) naÃ¯ve Non-dialysis Participants With Anemia Associated With Chronic Kidney Disease to Evaluate the Efficacy, Safety and Effects on Quality of Life of Daprodustat Compared to Placebo",205270,"Anaemia","Anemia|Hemoglobin C Disease|Hemoglobin SC Disease","Hematologic Diseases","Heme & Lymph Diseases","Experimental|Placebo Comparator","Daprodustat receivers|Placebo receivers","Subjects will receive oral daprodustat once daily|Subjects will receive oral placebo once daily","Drug","Daprodustat (GSK1278863)|Iron therapy|Placebo","Daprodustat will be available as 9 millimeter (mm) or 7 mm film-coated tablets. Daprodustat will be administered once daily via oral route and can be taken without regard to food.|Iron therapy will be administered if ferritin is <=50 Nano gram per milliliter and/or TSAT is <=15 percent.|Daprodustat matching placebo will be available as 9 mm or 7 mm film coated tablets. Placebo will be administered once daily via oral route and can be taken without regard to food.",null,"Daprodustat receivers|Placebo receivers","\n\n * >=18 years of age at the time of signing the informed consent.\n * Have CKD, confirmed at screening: Kidney Disease Outcomes Quality Initiative (KDOQI) CKD stages 3, 4, or 5 defined by Estimated glomerular filtration rate (eGFR) using the CKD Epidemiology Collaboration (CKD-EPI) formula.\n * Subjects with Stable HemoCue Hgb from 8.5 to 10.5 at screening visit (Week -4) and from 8.5 to 10.0 g/dL at randomization (Day 1).\n * Subjects may receive up to one intravenous (IV) iron dose within the 8 weeks prior to screening and NO IV iron use between screening visit and randomization (Day 1).\n * If needed, subject may be on stable maintenance oral iron supplementation. The type of iron and dose must not be changed for the 4 weeks prior to screening (Week -4), through the screening period, and until randomization (Day 1).\n * Male and female subjects are eligible. A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: Not a woman of childbearing potential (WOCBP) or WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 4 weeks after the last dose of study treatment.\n * Capable of giving signed informed consent.\n\n","\n\n * Subjects who are on dialysis or clinical evidence of impending need to initiate dialysis within 180 days after randomization (Day 1).\n * Planned living-related or living-unrelated kidney transplant within 28 weeks after randomization (Day 1).\n * Transferrin saturation (TSAT) <15 percent (Screening only).\n * Ferritin <50 nanograms per milliliter (ng/mL) (Screening only).\n * History of rhEPO or rhEPO analogue use within the 8 weeks prior to screening and rhEPO use between screening and randomization (Day 1).\n * History of transfusion within the 8 weeks prior to screening and transfusion between screening and randomization (Day 1).\n * History of bone marrow aplasia or pure red cell aplasia (PRCA).\n * Subjects with Megaloblastic anemia (untreated pernicious anemia and folate deficiency), thalassemia major, sickle cell disease or myelodysplastic syndrome.\n * Evidence of actively bleeding gastric, duodenal, or esophageal ulcer disease or clinically significant gastrointestinal (GI) bleeding <= 8 weeks prior to screening through to randomization (Day 1).\n * History of severe allergic or anaphylactic reactions or hypersensitivity to excipients in the investigational product.\n * Use of strong inhibitor of CYP2C8 (for example, gemfibrozil) or strong inducers of CYP2C8 (for example, rifampin/rifampicin).\n * Ferric citrate use within 4 weeks prior to randomization (Day 1).\n * Use of another investigational agent within 30 days or within five half-lives of the investigational agent (whichever is longer) or currently participating in a study of an investigational device prior to screening through to randomization (Day 1).\n * Any prior treatment with daprodustat for a treatment duration of >30 days.\n * MI or acute coronary syndrome within the 8 weeks prior to screening through to randomization. (Day 1).\n * Stroke or transient ischemic attack within the 8 weeks prior to screening through to randomization. (Day 1).\n * Chronic Class IV heart failure, as defined by the New York Heart Association (NYHA) functional classification system.\n * QT interval corrected by Bazett's formula (QTcB) >500 milliseconds (msec) or QTcB >530 msec in subjects with bundle branch block. There is no corrected QT interval (QTc) exclusion for subjects with a predominantly paced rhythm.\n * Alanine transaminase (ALT) >2x upper limit of normal (ULN) at screening (Week -4).\n * Bilirubin >1.5xULN at screening (Week -4).\n * Current unstable liver or biliary disease per investigator assessment, generally defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis.\n * History of malignancy within the 2 years prior to screening through to randomization (Day 1), or currently receiving treatment for cancer, or complex kidney cyst (for example, Bosniak Category II F, III or IV) > 3 centimeters (cm).\n * Any other condition, clinical or laboratory abnormality, or examination finding that the investigator considers would put the subject at unacceptable risk, which may affect study compliance or prevent understanding of the aims or investigational procedures or possible consequences of the study.","EGFR","epidermal growth factor receptor","Protein","Ovary, Breast, Lung","Actual","2018-01-24","Actual","Anticipated","2020-11-05","Anticipated","2018-08-01","2018-01-08","2018-01-17","2018-08-06","No","Non-Dialysis\nAnemia\nChronic kidney disease\nRecombinant human erythropoietin naÃ¯ve\nHemoglobin\nDaprodustat","Interventional","Treatment","Parallel Assignment","Double (Participant, Investigator)","Randomized","18 Years",null,"All",null,"No","Yes\nIPD for this study will be made available via the Clinical Study Data Request site.",{"$nulls":3},"Yes","No",{"$nulls":19},"Mean change from Baseline in Hgb up to evaluation period (EP)","The EP is from Week 24 to Week 28.","Baseline and up to Week 28","Number of subjects with Hgb increase of >=1.0 grams per deciliter (g/dL) from Baseline|Mean change from Baseline in short form-36 (SF-36) questionnaire vitality domain score|Incidences and severity of adverse events (AEs) and serious AEs (SAEs)|Number of Hgb responders|Mean change from Baseline for additional Hgb parameters|Time to rescue|Mean change from Baseline in CKD - Anemia Questionnaire (CKD-AQ) score|Change from Baseline in Patient Global Impression of Severity (PGI-S) score|Change from Baseline in work productivity and daily regular activity impairment|Change from Baseline in EuroQol 5 Dimension 5 Level Health Utility Index (EQ-5D-5L) score|Change from Baseline EuroQol Visual Analogue Scale (EQ-VAS) score","Number of subjects having a Hgb increase of >=1.0 g/dL from Baseline to EP.|Mean Change in SF-36 Vitality domain score between Baseline and Week 28.|Includes AEs of special interest and adjudicated Major adverse cardiovascular event (MACE) (composite of all-cause mortality, non-fatal Myocardial infarction|Responders will be defined as subjects whose mean Hgb is within target range.|Percentage time Hgb in range and mean change in Hgb from Baseline.|Rescue is defined as permanently stopping randomized treatment due to meeting rescue criteria.|Change from Baseline to week 28 by domain and overall symptom score.|Change from Baseline to Week 28 in symptom severity score.|Change for Baseline to week 28 in mean hours work time missed on the work productivity and activity impairment (WPAI-ANS-CPV) scale.|The EQ-5D-5L is a self-reported descriptive system of health-related quality of life states consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take one of five responses. The EQ-5D-5L score ranges from 1= no problem to 5= extreme problems. A unique health state is defined by combining score from each of the five dimensions.|The EQ-VAS is a part of EQ-5D-5L heath status. The EQ VAS records the self-rated health of a subject on a 20 cm vertical, visual analogue scale. The scale ranges from 0= 'the worst health you can imagine' to 100= 'the best health you can imagine'. This instrument can be used as a quantitative measure of health as judged by the individual.","Baseline and up to Week 28|Baseline and Week 28|MI and non-fatal stroke).|Up to Week 28","GSKClinicalSupportHD@gsk.com","US GSK Clinical Trials Call Center","877-379-3718","Ciudad Autonoma De Buenos Aires, Buenos Aires, Argentina, C1128Aaf|Sydney, New South Wales, Australia, 2010|Heidelberg, Victoria, Australia, 3084|Victoria, British Columbia, Canada, V8V 4A1|Brampton, Ontario, Canada, L6T 0G1|Grenoble Cedex 9, France, 38043|Catanzaro, Calabria, Italy, 88100|Pavia, Lombardia, Italy, 27100|Merida, Mexico, 97000|Merida, YucatÃ¡n, Mexico, 97070|Ciechanow, Poland, 06-400|Badalona, Spain, 08916|Canterbury, Kent, United Kingdom, Ct1 3Ng|Peterborough, United Kingdom, Pe3 9Gz|Homewood, Alabama, United States, 35209|Little Rock, Arkansas, United States, 72204|Fresno, California, United States, 93720|Middlebury, Connecticut, United States, 06762|Hollywood, Florida, United States, 33021-5424|Macon, Georgia, United States, 31217|Buckley, Michigan, United States, 49620|Saint Louis, Missouri, United States, 63136|Portsmouth, New Hampshire, United States, 03801|Asheville, North Carolina, United States, 28801|Oklahoma City, Oklahoma, United States, 73112|Beaver, Pennsylvania, United States, 15009|Orangeburg, South Carolina, United States, 29118|Desoto, Texas, United States, 75115|Norfolk, Virginia, United States, 23502","Alabama|Arkansas|California|Connecticut|Florida|Georgia|Michigan|Missouri|New Hampshire|North Carolina|Oklahoma|Pennsylvania|South Carolina|Texas|Virginia","Argentina|Australia|Canada|France|Italy|Mexico|Poland|Spain|United Kingdom|United States","Buenos Aires Gsk Investigational Site|New South Wales Gsk Investigational Site|Victoria Gsk Investigational Site|British Columbia Gsk Investigational Site|Ontario Gsk Investigational Site|Gsk Investigational Site|Calabria Gsk Investigational Site|Lombardia Gsk Investigational Site|YucatÃ¡n Gsk Investigational Site|, Kent Gsk Investigational Site",{"$nulls":3},"GSK Clinical Trials","2018-08-06","2020-05-25T16:38:26.928","2020-05-26T17:10:42.972","NCT03409107"]
["5ecbf483feab101b1553095a","NCT03409107","2018-08-17","GlaxoSmithKline","GSK","Recruiting","Anemia Studies in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat in Non-Dialysis Subjects Evaluating Hemoglobin (Hgb) and Quality of Life (ASCEND-NHQ)","Daprodustat","HIF Inhibitor","Yes","['Daprodustat']","Yes","['HIF Inhibitor']","Phase 3",2,600,"Anticipated","2018-03-05","2020-11-05",{"$nulls":5},"The purpose of this multi-center study in non-dialysis subjects with anemia associated with CKD is to evaluate safety, efficacy and quality of life of daprodustat compared to placebo.",null,"A 28-week, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center, Study in Recombinant Human Erythropoietin (rhEPO) naÃ¯ve Non-dialysis Participants With Anemia Associated With Chronic Kidney Disease to Evaluate the Efficacy, Safety and Effects on Quality of Life of Daprodustat Compared to Placebo",205270,"Anaemia","Anemia|Hemoglobin C Disease|Hemoglobin SC Disease","Hematologic Diseases","Heme & Lymph Diseases","Experimental|Placebo Comparator","Daprodustat receivers|Placebo receivers","Subjects will receive oral daprodustat once daily|Subjects will receive oral placebo once daily","Drug","Daprodustat (GSK1278863)|Iron therapy|Placebo","Daprodustat will be available as 9 millimeter (mm) or 7 mm film-coated tablets. Daprodustat will be administered once daily via oral route and can be taken without regard to food.|Iron therapy will be administered if ferritin is <=50 Nano gram per milliliter and/or TSAT is <=15 percent.|Daprodustat matching placebo will be available as 9 mm or 7 mm film coated tablets. Placebo will be administered once daily via oral route and can be taken without regard to food.",null,"Daprodustat receivers|Placebo receivers","\n\n * >=18 years of age at the time of signing the informed consent.\n * Have CKD, confirmed at screening: Kidney Disease Outcomes Quality Initiative (KDOQI) CKD stages 3, 4, or 5 defined by Estimated glomerular filtration rate (eGFR) using the CKD Epidemiology Collaboration (CKD-EPI) formula.\n * Subjects with Stable HemoCue Hgb from 8.5 to 10.5 at screening visit (Week -4) and from 8.5 to 10.0 g/dL at randomization (Day 1).\n * Subjects may receive up to one intravenous (IV) iron dose within the 8 weeks prior to screening and NO IV iron use between screening visit and randomization (Day 1).\n * If needed, subject may be on stable maintenance oral iron supplementation. The type of iron and dose must not be changed for the 4 weeks prior to screening (Week -4), through the screening period, and until randomization (Day 1).\n * Male and female subjects are eligible. A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: Not a woman of childbearing potential (WOCBP) or WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 4 weeks after the last dose of study treatment.\n * Capable of giving signed informed consent.\n\n","\n\n * Subjects who are on dialysis or clinical evidence of impending need to initiate dialysis within 180 days after randomization (Day 1).\n * Planned living-related or living-unrelated kidney transplant within 28 weeks after randomization (Day 1).\n * Transferrin saturation (TSAT) <15 percent (Screening only).\n * Ferritin <50 nanograms per milliliter (ng/mL) (Screening only).\n * History of rhEPO or rhEPO analogue use within the 8 weeks prior to screening and rhEPO use between screening and randomization (Day 1).\n * History of transfusion within the 8 weeks prior to screening and transfusion between screening and randomization (Day 1).\n * History of bone marrow aplasia or pure red cell aplasia (PRCA).\n * Subjects with Megaloblastic anemia (untreated pernicious anemia and folate deficiency), thalassemia major, sickle cell disease or myelodysplastic syndrome.\n * Evidence of actively bleeding gastric, duodenal, or esophageal ulcer disease or clinically significant gastrointestinal (GI) bleeding <= 8 weeks prior to screening through to randomization (Day 1).\n * History of severe allergic or anaphylactic reactions or hypersensitivity to excipients in the investigational product.\n * Use of strong inhibitor of CYP2C8 (for example, gemfibrozil) or strong inducers of CYP2C8 (for example, rifampin/rifampicin).\n * Ferric citrate use within 4 weeks prior to randomization (Day 1).\n * Use of another investigational agent within 30 days or within five half-lives of the investigational agent (whichever is longer) or currently participating in a study of an investigational device prior to screening through to randomization (Day 1).\n * Any prior treatment with daprodustat for a treatment duration of >30 days.\n * MI or acute coronary syndrome within the 8 weeks prior to screening through to randomization. (Day 1).\n * Stroke or transient ischemic attack within the 8 weeks prior to screening through to randomization. (Day 1).\n * Chronic Class IV heart failure, as defined by the New York Heart Association (NYHA) functional classification system.\n * QT interval corrected by Bazett's formula (QTcB) >500 milliseconds (msec) or QTcB >530 msec in subjects with bundle branch block. There is no corrected QT interval (QTc) exclusion for subjects with a predominantly paced rhythm.\n * Alanine transaminase (ALT) >2x upper limit of normal (ULN) at screening (Week -4).\n * Bilirubin >1.5xULN at screening (Week -4).\n * Current unstable liver or biliary disease per investigator assessment, generally defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis.\n * History of malignancy within the 2 years prior to screening through to randomization (Day 1), or currently receiving treatment for cancer, or complex kidney cyst (for example, Bosniak Category II F, III or IV) > 3 centimeters (cm).\n * Any other condition, clinical or laboratory abnormality, or examination finding that the investigator considers would put the subject at unacceptable risk, which may affect study compliance or prevent understanding of the aims or investigational procedures or possible consequences of the study.","EGFR","epidermal growth factor receptor","Protein","Ovary, Breast, Lung","Actual","2018-01-24","Actual","Anticipated","2020-11-05","Anticipated","2018-08-01","2018-01-08","2018-01-17","2018-08-16","No","Non-Dialysis\nAnemia\nChronic kidney disease\nRecombinant human erythropoietin naÃ¯ve\nHemoglobin\nDaprodustat","Interventional","Treatment","Parallel Assignment","Double (Participant, Investigator)","Randomized","18 Years",null,"All",null,"No","Yes\nIPD for this study will be made available via the Clinical Study Data Request site.",{"$nulls":3},"Yes","No",{"$nulls":19},"Mean change from Baseline in Hgb up to evaluation period (EP)","The EP is from Week 24 to Week 28.","Baseline and up to Week 28","Number of subjects with Hgb increase of >=1.0 grams per deciliter (g/dL) from Baseline|Mean change from Baseline in short form-36 (SF-36) questionnaire vitality domain score|Incidences and severity of adverse events (AEs) and serious AEs (SAEs)|Number of Hgb responders|Mean change from Baseline for additional Hgb parameters|Time to rescue|Mean change from Baseline in CKD - Anemia Questionnaire (CKD-AQ) score|Change from Baseline in Patient Global Impression of Severity (PGI-S) score|Change from Baseline in work productivity and daily regular activity impairment|Change from Baseline in EuroQol 5 Dimension 5 Level Health Utility Index (EQ-5D-5L) score|Change from Baseline EuroQol Visual Analogue Scale (EQ-VAS) score","Number of subjects having a Hgb increase of >=1.0 g/dL from Baseline to EP.|Mean Change in SF-36 Vitality domain score between Baseline and Week 28.|Includes AEs of special interest and adjudicated Major adverse cardiovascular event (MACE) (composite of all-cause mortality, non-fatal Myocardial infarction|Responders will be defined as subjects whose mean Hgb is within target range.|Percentage time Hgb in range and mean change in Hgb from Baseline.|Rescue is defined as permanently stopping randomized treatment due to meeting rescue criteria.|Change from Baseline to week 28 by domain and overall symptom score.|Change from Baseline to Week 28 in symptom severity score.|Change for Baseline to week 28 in mean hours work time missed on the work productivity and activity impairment (WPAI-ANS-CPV) scale.|The EQ-5D-5L is a self-reported descriptive system of health-related quality of life states consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take one of five responses. The EQ-5D-5L score ranges from 1= no problem to 5= extreme problems. A unique health state is defined by combining score from each of the five dimensions.|The EQ-VAS is a part of EQ-5D-5L heath status. The EQ VAS records the self-rated health of a subject on a 20 cm vertical, visual analogue scale. The scale ranges from 0= 'the worst health you can imagine' to 100= 'the best health you can imagine'. This instrument can be used as a quantitative measure of health as judged by the individual.","Baseline and up to Week 28|Baseline and Week 28|MI and non-fatal stroke).|Up to Week 28","GSKClinicalSupportHD@gsk.com","US GSK Clinical Trials Call Center","877-379-3718","Ciudad Autonoma De Buenos Aires, Buenos Aires, Argentina, C1128Aaf|Sydney, New South Wales, Australia, 2010|Heidelberg, Victoria, Australia, 3084|Victoria, British Columbia, Canada, V8V 4A1|Brampton, Ontario, Canada, L6T 0G1|Grenoble Cedex 9, France, 38043|Catanzaro, Calabria, Italy, 88100|Pavia, Lombardia, Italy, 27100|Merida, Mexico, 97000|Guadalajara, Jalisco, Mexico, 44150|CÃ³rdoba, Veracruz, Mexico, 94550|Merida, YucatÃ¡n, Mexico, 97070|Ciechanow, Poland, 06-400|Cluj-Napoca, Romania, 400139|Badalona, Spain, 08916|Canterbury, Kent, United Kingdom, Ct1 3Ng|Peterborough, United Kingdom, Pe3 9Gz|Homewood, Alabama, United States, 35209|Little Rock, Arkansas, United States, 72204|Fresno, California, United States, 93720|Middlebury, Connecticut, United States, 06762|Hollywood, Florida, United States, 33021-5424|Macon, Georgia, United States, 31217|Buckley, Michigan, United States, 49620|Saint Louis, Missouri, United States, 63136|Portsmouth, New Hampshire, United States, 03801|Asheville, North Carolina, United States, 28801|Oklahoma City, Oklahoma, United States, 73112|Beaver, Pennsylvania, United States, 15009|Orangeburg, South Carolina, United States, 29118|Desoto, Texas, United States, 75115|Norfolk, Virginia, United States, 23502","Alabama|Arkansas|California|Connecticut|Florida|Georgia|Michigan|Missouri|New Hampshire|North Carolina|Oklahoma|Pennsylvania|South Carolina|Texas|Virginia","Argentina|Australia|Canada|France|Italy|Mexico|Poland|Romania|Spain|United Kingdom|United States","Buenos Aires Gsk Investigational Site|New South Wales Gsk Investigational Site|Victoria Gsk Investigational Site|British Columbia Gsk Investigational Site|Ontario Gsk Investigational Site|Gsk Investigational Site|Calabria Gsk Investigational Site|Lombardia Gsk Investigational Site|Jalisco Gsk Investigational Site|Veracruz Gsk Investigational Site|YucatÃ¡n Gsk Investigational Site|, Kent Gsk Investigational Site",{"$nulls":3},"GSK Clinical Trials","2018-08-16","2020-05-25T16:38:27.177","2020-05-26T17:10:42.972","NCT03409107"]
["5ecbf48311702c1b1b916b39","NCT03409107","2018-08-24","GlaxoSmithKline","GSK","Recruiting","Anemia Studies in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat in Non-Dialysis Subjects Evaluating Hemoglobin (Hgb) and Quality of Life (ASCEND-NHQ)","Daprodustat","HIF Inhibitor","Yes","['Daprodustat']","Yes","['HIF Inhibitor']","Phase 3",2,600,"Anticipated","2018-03-05","2020-11-05",{"$nulls":5},"The purpose of this multi-center study in non-dialysis subjects with anemia associated with CKD is to evaluate safety, efficacy and quality of life of daprodustat compared to placebo.",null,"A 28-week, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center, Study in Recombinant Human Erythropoietin (rhEPO) naÃ¯ve Non-dialysis Participants With Anemia Associated With Chronic Kidney Disease to Evaluate the Efficacy, Safety and Effects on Quality of Life of Daprodustat Compared to Placebo",205270,"Anaemia","Anemia|Hemoglobin C Disease|Hemoglobin SC Disease","Hematologic Diseases","Heme & Lymph Diseases","Experimental|Placebo Comparator","Daprodustat receivers|Placebo receivers","Subjects will receive oral daprodustat once daily|Subjects will receive oral placebo once daily","Drug","Daprodustat (GSK1278863)|Iron therapy|Placebo","Daprodustat will be available as 9 millimeter (mm) or 7 mm film-coated tablets. Daprodustat will be administered once daily via oral route and can be taken without regard to food.|Iron therapy will be administered if ferritin is <=50 Nano gram per milliliter and/or TSAT is <=15 percent.|Daprodustat matching placebo will be available as 9 mm or 7 mm film coated tablets. Placebo will be administered once daily via oral route and can be taken without regard to food.",null,"Daprodustat receivers|Placebo receivers","\n\n * >=18 years of age at the time of signing the informed consent.\n * Have CKD, confirmed at screening: Kidney Disease Outcomes Quality Initiative (KDOQI) CKD stages 3, 4, or 5 defined by Estimated glomerular filtration rate (eGFR) using the CKD Epidemiology Collaboration (CKD-EPI) formula.\n * Subjects with Stable HemoCue Hgb from 8.5 to 10.5 at screening visit (Week -4) and from 8.5 to 10.0 g/dL at randomization (Day 1).\n * Subjects may receive up to one intravenous (IV) iron dose within the 8 weeks prior to screening and NO IV iron use between screening visit and randomization (Day 1).\n * If needed, subject may be on stable maintenance oral iron supplementation. The type of iron and dose must not be changed for the 4 weeks prior to screening (Week -4), through the screening period, and until randomization (Day 1).\n * Male and female subjects are eligible. A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: Not a woman of childbearing potential (WOCBP) or WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 4 weeks after the last dose of study treatment.\n * Capable of giving signed informed consent.\n\n","\n\n * Subjects who are on dialysis or clinical evidence of impending need to initiate dialysis within 180 days after randomization (Day 1).\n * Planned living-related or living-unrelated kidney transplant within 28 weeks after randomization (Day 1).\n * Transferrin saturation (TSAT) <15 percent (Screening only).\n * Ferritin <50 nanograms per milliliter (ng/mL) (Screening only).\n * History of rhEPO or rhEPO analogue use within the 8 weeks prior to screening and rhEPO use between screening and randomization (Day 1).\n * History of transfusion within the 8 weeks prior to screening and transfusion between screening and randomization (Day 1).\n * History of bone marrow aplasia or pure red cell aplasia (PRCA).\n * Subjects with Megaloblastic anemia (untreated pernicious anemia and folate deficiency), thalassemia major, sickle cell disease or myelodysplastic syndrome.\n * Evidence of actively bleeding gastric, duodenal, or esophageal ulcer disease or clinically significant gastrointestinal (GI) bleeding <= 8 weeks prior to screening through to randomization (Day 1).\n * History of severe allergic or anaphylactic reactions or hypersensitivity to excipients in the investigational product.\n * Use of strong inhibitor of CYP2C8 (for example, gemfibrozil) or strong inducers of CYP2C8 (for example, rifampin/rifampicin).\n * Ferric citrate use within 4 weeks prior to randomization (Day 1).\n * Use of another investigational agent within 30 days or within five half-lives of the investigational agent (whichever is longer) or currently participating in a study of an investigational device prior to screening through to randomization (Day 1).\n * Any prior treatment with daprodustat for a treatment duration of >30 days.\n * MI or acute coronary syndrome within the 8 weeks prior to screening through to randomization. (Day 1).\n * Stroke or transient ischemic attack within the 8 weeks prior to screening through to randomization. (Day 1).\n * Chronic Class IV heart failure, as defined by the New York Heart Association (NYHA) functional classification system.\n * QT interval corrected by Bazett's formula (QTcB) >500 milliseconds (msec) or QTcB >530 msec in subjects with bundle branch block. There is no corrected QT interval (QTc) exclusion for subjects with a predominantly paced rhythm.\n * Alanine transaminase (ALT) >2x upper limit of normal (ULN) at screening (Week -4).\n * Bilirubin >1.5xULN at screening (Week -4).\n * Current unstable liver or biliary disease per investigator assessment, generally defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis.\n * History of malignancy within the 2 years prior to screening through to randomization (Day 1), or currently receiving treatment for cancer, or complex kidney cyst (for example, Bosniak Category II F, III or IV) > 3 centimeters (cm).\n * Any other condition, clinical or laboratory abnormality, or examination finding that the investigator considers would put the subject at unacceptable risk, which may affect study compliance or prevent understanding of the aims or investigational procedures or possible consequences of the study.","EGFR","epidermal growth factor receptor","Protein","Ovary, Breast, Lung","Actual","2018-01-24","Actual","Anticipated","2020-11-05","Anticipated","2018-08-01","2018-01-08","2018-01-17","2018-08-23","No","Non-Dialysis\nAnemia\nChronic kidney disease\nRecombinant human erythropoietin naÃ¯ve\nHemoglobin\nDaprodustat","Interventional","Treatment","Parallel Assignment","Double (Participant, Investigator)","Randomized","18 Years",null,"All",null,"No","Yes\nIPD for this study will be made available via the Clinical Study Data Request site.",{"$nulls":3},"Yes","No",{"$nulls":19},"Mean change from Baseline in Hgb up to evaluation period (EP)","The EP is from Week 24 to Week 28.","Baseline and up to Week 28","Number of subjects with Hgb increase of >=1.0 grams per deciliter (g/dL) from Baseline|Mean change from Baseline in short form-36 (SF-36) questionnaire vitality domain score|Incidences and severity of adverse events (AEs) and serious AEs (SAEs)|Number of Hgb responders|Mean change from Baseline for additional Hgb parameters|Time to rescue|Mean change from Baseline in CKD - Anemia Questionnaire (CKD-AQ) score|Change from Baseline in Patient Global Impression of Severity (PGI-S) score|Change from Baseline in work productivity and daily regular activity impairment|Change from Baseline in EuroQol 5 Dimension 5 Level Health Utility Index (EQ-5D-5L) score|Change from Baseline EuroQol Visual Analogue Scale (EQ-VAS) score","Number of subjects having a Hgb increase of >=1.0 g/dL from Baseline to EP.|Mean Change in SF-36 Vitality domain score between Baseline and Week 28.|Includes AEs of special interest and adjudicated Major adverse cardiovascular event (MACE) (composite of all-cause mortality, non-fatal Myocardial infarction|Responders will be defined as subjects whose mean Hgb is within target range.|Percentage time Hgb in range and mean change in Hgb from Baseline.|Rescue is defined as permanently stopping randomized treatment due to meeting rescue criteria.|Change from Baseline to week 28 by domain and overall symptom score.|Change from Baseline to Week 28 in symptom severity score.|Change for Baseline to week 28 in mean hours work time missed on the work productivity and activity impairment (WPAI-ANS-CPV) scale.|The EQ-5D-5L is a self-reported descriptive system of health-related quality of life states consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take one of five responses. The EQ-5D-5L score ranges from 1= no problem to 5= extreme problems. A unique health state is defined by combining score from each of the five dimensions.|The EQ-VAS is a part of EQ-5D-5L heath status. The EQ VAS records the self-rated health of a subject on a 20 cm vertical, visual analogue scale. The scale ranges from 0= 'the worst health you can imagine' to 100= 'the best health you can imagine'. This instrument can be used as a quantitative measure of health as judged by the individual.","Baseline and up to Week 28|Baseline and Week 28|MI and non-fatal stroke).|Up to Week 28","GSKClinicalSupportHD@gsk.com","US GSK Clinical Trials Call Center","877-379-3718","Ciudad Autonoma De Buenos Aires, Buenos Aires, Argentina, C1128Aaf|Sydney, New South Wales, Australia, 2010|Heidelberg, Victoria, Australia, 3084|Victoria, British Columbia, Canada, V8V 4A1|Brampton, Ontario, Canada, L6T 0G1|Grenoble Cedex 9, France, 38043|Catanzaro, Calabria, Italy, 88100|Pavia, Lombardia, Italy, 27100|Merida, Mexico, 97000|Guadalajara, Jalisco, Mexico, 44150|CÃ³rdoba, Veracruz, Mexico, 94550|Merida, YucatÃ¡n, Mexico, 97070|Ciechanow, Poland, 06-400|Cluj-Napoca, Romania, 400139|Badalona, Spain, 08916|Canterbury, Kent, United Kingdom, Ct1 3Ng|Peterborough, United Kingdom, Pe3 9Gz|Homewood, Alabama, United States, 35209|Little Rock, Arkansas, United States, 72204|Fresno, California, United States, 93720|Middlebury, Connecticut, United States, 06762|Hollywood, Florida, United States, 33021-5424|Macon, Georgia, United States, 31217|Buckley, Michigan, United States, 49620|Saint Louis, Missouri, United States, 63136|Portsmouth, New Hampshire, United States, 03801|Asheville, North Carolina, United States, 28801|Oklahoma City, Oklahoma, United States, 73112|Beaver, Pennsylvania, United States, 15009|Orangeburg, South Carolina, United States, 29118|Desoto, Texas, United States, 75115|Norfolk, Virginia, United States, 23502","Alabama|Arkansas|California|Connecticut|Florida|Georgia|Michigan|Missouri|New Hampshire|North Carolina|Oklahoma|Pennsylvania|South Carolina|Texas|Virginia","Argentina|Australia|Canada|France|Italy|Mexico|Poland|Romania|Spain|United Kingdom|United States","Buenos Aires Gsk Investigational Site|New South Wales Gsk Investigational Site|Victoria Gsk Investigational Site|British Columbia Gsk Investigational Site|Ontario Gsk Investigational Site|Gsk Investigational Site|Calabria Gsk Investigational Site|Lombardia Gsk Investigational Site|Jalisco Gsk Investigational Site|Veracruz Gsk Investigational Site|YucatÃ¡n Gsk Investigational Site|, Kent Gsk Investigational Site",{"$nulls":3},"GSK Clinical Trials","2018-08-23","2020-05-25T16:38:27.205","2020-05-26T17:10:42.972","NCT03409107"]
["5ecbf483feab101b1553095b","NCT03409107","2018-09-11","GlaxoSmithKline","GSK","Recruiting","Anemia Studies in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat in Non-Dialysis Subjects Evaluating Hemoglobin (Hgb) and Quality of Life (ASCEND-NHQ)","Daprodustat","HIF Inhibitor","Yes","['Daprodustat']","Yes","['HIF Inhibitor']","Phase 3",2,600,"Anticipated","2018-03-05","2020-11-05",{"$nulls":5},"The purpose of this multi-center study in non-dialysis subjects with anemia associated with CKD is to evaluate safety, efficacy and quality of life of daprodustat compared to placebo.",null,"A 28-week, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center, Study in Recombinant Human Erythropoietin (rhEPO) naÃ¯ve Non-dialysis Participants With Anemia Associated With Chronic Kidney Disease to Evaluate the Efficacy, Safety and Effects on Quality of Life of Daprodustat Compared to Placebo",205270,"Anaemia","Anemia|Hemoglobin C Disease|Hemoglobin SC Disease","Hematologic Diseases","Heme & Lymph Diseases","Experimental|Placebo Comparator","Daprodustat receivers|Placebo receivers","Subjects will receive oral daprodustat once daily|Subjects will receive oral placebo once daily","Drug","Daprodustat (GSK1278863)|Iron therapy|Placebo","Daprodustat will be available as 9 millimeter (mm) or 7 mm film-coated tablets. Daprodustat will be administered once daily via oral route and can be taken without regard to food.|Iron therapy will be administered if ferritin is <=50 Nano gram per milliliter and/or TSAT is <=15 percent.|Daprodustat matching placebo will be available as 9 mm or 7 mm film coated tablets. Placebo will be administered once daily via oral route and can be taken without regard to food.",null,"Daprodustat receivers|Placebo receivers","\n\n * >=18 years of age at the time of signing the informed consent.\n * Have CKD, confirmed at screening: Kidney Disease Outcomes Quality Initiative (KDOQI) CKD stages 3, 4, or 5 defined by Estimated glomerular filtration rate (eGFR) using the CKD Epidemiology Collaboration (CKD-EPI) formula.\n * Subjects with Stable HemoCue Hgb from 8.5 to 10.5 at screening visit (Week -4) and from 8.5 to 10.0 g/dL at randomization (Day 1).\n * Subjects may receive up to one intravenous (IV) iron dose within the 8 weeks prior to screening and NO IV iron use between screening visit and randomization (Day 1).\n * If needed, subject may be on stable maintenance oral iron supplementation. The type of iron and dose must not be changed for the 4 weeks prior to screening (Week -4), through the screening period, and until randomization (Day 1).\n * Male and female subjects are eligible. A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: Not a woman of childbearing potential (WOCBP) or WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 4 weeks after the last dose of study treatment.\n * Capable of giving signed informed consent.\n\n","\n\n * Subjects who are on dialysis or clinical evidence of impending need to initiate dialysis within 180 days after randomization (Day 1).\n * Planned living-related or living-unrelated kidney transplant within 28 weeks after randomization (Day 1).\n * Transferrin saturation (TSAT) <15 percent (Screening only).\n * Ferritin <50 nanograms per milliliter (ng/mL) (Screening only).\n * History of rhEPO or rhEPO analogue use within the 8 weeks prior to screening and rhEPO use between screening and randomization (Day 1).\n * History of transfusion within the 8 weeks prior to screening and transfusion between screening and randomization (Day 1).\n * History of bone marrow aplasia or pure red cell aplasia (PRCA).\n * Subjects with Megaloblastic anemia (untreated pernicious anemia and folate deficiency), thalassemia major, sickle cell disease or myelodysplastic syndrome.\n * Evidence of actively bleeding gastric, duodenal, or esophageal ulcer disease or clinically significant gastrointestinal (GI) bleeding <= 8 weeks prior to screening through to randomization (Day 1).\n * History of severe allergic or anaphylactic reactions or hypersensitivity to excipients in the investigational product.\n * Use of strong inhibitor of CYP2C8 (for example, gemfibrozil) or strong inducers of CYP2C8 (for example, rifampin/rifampicin).\n * Ferric citrate use within 4 weeks prior to randomization (Day 1).\n * Use of another investigational agent within 30 days or within five half-lives of the investigational agent (whichever is longer) or currently participating in a study of an investigational device prior to screening through to randomization (Day 1).\n * Any prior treatment with daprodustat for a treatment duration of >30 days.\n * MI or acute coronary syndrome within the 8 weeks prior to screening through to randomization. (Day 1).\n * Stroke or transient ischemic attack within the 8 weeks prior to screening through to randomization. (Day 1).\n * Chronic Class IV heart failure, as defined by the New York Heart Association (NYHA) functional classification system.\n * QT interval corrected by Bazett's formula (QTcB) >500 milliseconds (msec) or QTcB >530 msec in subjects with bundle branch block. There is no corrected QT interval (QTc) exclusion for subjects with a predominantly paced rhythm.\n * Alanine transaminase (ALT) >2x upper limit of normal (ULN) at screening (Week -4).\n * Bilirubin >1.5xULN at screening (Week -4).\n * Current unstable liver or biliary disease per investigator assessment, generally defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis.\n * History of malignancy within the 2 years prior to screening through to randomization (Day 1), or currently receiving treatment for cancer, or complex kidney cyst (for example, Bosniak Category II F, III or IV) > 3 centimeters (cm).\n * Any other condition, clinical or laboratory abnormality, or examination finding that the investigator considers would put the subject at unacceptable risk, which may affect study compliance or prevent understanding of the aims or investigational procedures or possible consequences of the study.","EGFR","epidermal growth factor receptor","Protein","Ovary, Breast, Lung","Actual","2018-01-24","Actual","Anticipated","2020-11-05","Anticipated","2018-09-01","2018-01-08","2018-01-17","2018-09-10","No","Non-Dialysis\nAnemia\nChronic kidney disease\nRecombinant human erythropoietin naÃ¯ve\nHemoglobin\nDaprodustat","Interventional","Treatment","Parallel Assignment","Double (Participant, Investigator)","Randomized","18 Years",null,"All",null,"No","Yes\nIPD for this study will be made available via the Clinical Study Data Request site.",{"$nulls":3},"Yes","No",{"$nulls":19},"Mean change from Baseline in Hgb up to evaluation period (EP)","The EP is from Week 24 to Week 28.","Baseline and up to Week 28","Number of subjects with Hgb increase of >=1.0 grams per deciliter (g/dL) from Baseline|Mean change from Baseline in short form-36 (SF-36) questionnaire vitality domain score|Incidences and severity of adverse events (AEs) and serious AEs (SAEs)|Number of Hgb responders|Mean change from Baseline for additional Hgb parameters|Time to rescue|Mean change from Baseline in CKD - Anemia Questionnaire (CKD-AQ) score|Change from Baseline in Patient Global Impression of Severity (PGI-S) score|Change from Baseline in work productivity and daily regular activity impairment|Change from Baseline in EuroQol 5 Dimension 5 Level Health Utility Index (EQ-5D-5L) score|Change from Baseline EuroQol Visual Analogue Scale (EQ-VAS) score","Number of subjects having a Hgb increase of >=1.0 g/dL from Baseline to EP.|Mean Change in SF-36 Vitality domain score between Baseline and Week 28.|Includes AEs of special interest and adjudicated Major adverse cardiovascular event (MACE) (composite of all-cause mortality, non-fatal Myocardial infarction|Responders will be defined as subjects whose mean Hgb is within target range.|Percentage time Hgb in range and mean change in Hgb from Baseline.|Rescue is defined as permanently stopping randomized treatment due to meeting rescue criteria.|Change from Baseline to week 28 by domain and overall symptom score.|Change from Baseline to Week 28 in symptom severity score.|Change for Baseline to week 28 in mean hours work time missed on the work productivity and activity impairment (WPAI-ANS-CPV) scale.|The EQ-5D-5L is a self-reported descriptive system of health-related quality of life states consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take one of five responses. The EQ-5D-5L score ranges from 1= no problem to 5= extreme problems. A unique health state is defined by combining score from each of the five dimensions.|The EQ-VAS is a part of EQ-5D-5L heath status. The EQ VAS records the self-rated health of a subject on a 20 cm vertical, visual analogue scale. The scale ranges from 0= 'the worst health you can imagine' to 100= 'the best health you can imagine'. This instrument can be used as a quantitative measure of health as judged by the individual.","Baseline and up to Week 28|Baseline and Week 28|MI and non-fatal stroke).|Up to Week 28","GSKClinicalSupportHD@gsk.com","US GSK Clinical Trials Call Center","877-379-3718","Ciudad Autonoma De Buenos Aires, Buenos Aires, Argentina, C1128Aaf|Sydney, New South Wales, Australia, 2010|Heidelberg, Victoria, Australia, 3084|Victoria, British Columbia, Canada, V8V 4A1|Brampton, Ontario, Canada, L6T 0G1|Grenoble Cedex 9, France, 38043|Catanzaro, Calabria, Italy, 88100|Pavia, Lombardia, Italy, 27100|Merida, Mexico, 97000|Guadalajara, Jalisco, Mexico, 44150|CÃ³rdoba, Veracruz, Mexico, 94550|Merida, YucatÃ¡n, Mexico, 97070|Ciechanow, Poland, 06-400|Cluj-Napoca, Romania, 400139|Badalona, Spain, 08916|Canterbury, Kent, United Kingdom, Ct1 3Ng|Peterborough, United Kingdom, Pe3 9Gz|Homewood, Alabama, United States, 35209|Little Rock, Arkansas, United States, 72204|Fresno, California, United States, 93720|Middlebury, Connecticut, United States, 06762|Hollywood, Florida, United States, 33021-5424|Macon, Georgia, United States, 31217|Buckley, Michigan, United States, 49620|Saint Louis, Missouri, United States, 63136|Portsmouth, New Hampshire, United States, 03801|Asheville, North Carolina, United States, 28801|Oklahoma City, Oklahoma, United States, 73112|Beaver, Pennsylvania, United States, 15009|Orangeburg, South Carolina, United States, 29118|Desoto, Texas, United States, 75115|Norfolk, Virginia, United States, 23502","Alabama|Arkansas|California|Connecticut|Florida|Georgia|Michigan|Missouri|New Hampshire|North Carolina|Oklahoma|Pennsylvania|South Carolina|Texas|Virginia","Argentina|Australia|Canada|France|Italy|Mexico|Poland|Romania|Spain|United Kingdom|United States","Buenos Aires Gsk Investigational Site|New South Wales Gsk Investigational Site|Victoria Gsk Investigational Site|British Columbia Gsk Investigational Site|Ontario Gsk Investigational Site|Gsk Investigational Site|Calabria Gsk Investigational Site|Lombardia Gsk Investigational Site|Jalisco Gsk Investigational Site|Veracruz Gsk Investigational Site|YucatÃ¡n Gsk Investigational Site|, Kent Gsk Investigational Site",{"$nulls":3},"GSK Clinical Trials","2018-09-10","2020-05-25T16:38:27.774","2020-05-26T17:10:42.972","NCT03409107"]
["5ecbf483307e3d1b1f8d9dbd","NCT03409107","2018-09-17","GlaxoSmithKline","GSK","Recruiting","Anemia Studies in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat in Non-Dialysis Subjects Evaluating Hemoglobin (Hgb) and Quality of Life (ASCEND-NHQ)","Daprodustat","HIF Inhibitor","Yes","['Daprodustat']","Yes","['HIF Inhibitor']","Phase 3",2,600,"Anticipated","2018-03-05","2020-11-05",{"$nulls":5},"The purpose of this multi-center study in non-dialysis subjects with anemia associated with CKD is to evaluate safety, efficacy and quality of life of daprodustat compared to placebo.",null,"A 28-week, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center, Study in Recombinant Human Erythropoietin (rhEPO) naÃ¯ve Non-dialysis Participants With Anemia Associated With Chronic Kidney Disease to Evaluate the Efficacy, Safety and Effects on Quality of Life of Daprodustat Compared to Placebo",205270,"Anaemia","Anemia|Hemoglobin C Disease|Hemoglobin SC Disease","Hematologic Diseases","Heme & Lymph Diseases","Experimental|Placebo Comparator","Daprodustat receivers|Placebo receivers","Subjects will receive oral daprodustat once daily|Subjects will receive oral placebo once daily","Drug","Daprodustat (GSK1278863)|Iron therapy|Placebo","Daprodustat will be available as 9 millimeter (mm) or 7 mm film-coated tablets. Daprodustat will be administered once daily via oral route and can be taken without regard to food.|Iron therapy will be administered if ferritin is <=50 Nano gram per milliliter and/or TSAT is <=15 percent.|Daprodustat matching placebo will be available as 9 mm or 7 mm film coated tablets. Placebo will be administered once daily via oral route and can be taken without regard to food.",null,"Daprodustat receivers|Placebo receivers","\n\n * >=18 years of age at the time of signing the informed consent.\n * Have CKD, confirmed at screening: Kidney Disease Outcomes Quality Initiative (KDOQI) CKD stages 3, 4, or 5 defined by Estimated glomerular filtration rate (eGFR) using the CKD Epidemiology Collaboration (CKD-EPI) formula.\n * Subjects with Stable HemoCue Hgb from 8.5 to 10.5 at screening visit (Week -4) and from 8.5 to 10.0 g/dL at randomization (Day 1).\n * Subjects may receive up to one intravenous (IV) iron dose within the 8 weeks prior to screening and NO IV iron use between screening visit and randomization (Day 1).\n * If needed, subject may be on stable maintenance oral iron supplementation. The type of iron and dose must not be changed for the 4 weeks prior to screening (Week -4), through the screening period, and until randomization (Day 1).\n * Male and female subjects are eligible. A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: Not a woman of childbearing potential (WOCBP) or WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 4 weeks after the last dose of study treatment.\n * Capable of giving signed informed consent.\n\n","\n\n * Subjects who are on dialysis or clinical evidence of impending need to initiate dialysis within 180 days after randomization (Day 1).\n * Planned living-related or living-unrelated kidney transplant within 28 weeks after randomization (Day 1).\n * Transferrin saturation (TSAT) <15 percent (Screening only).\n * Ferritin <50 nanograms per milliliter (ng/mL) (Screening only).\n * History of rhEPO or rhEPO analogue use within the 8 weeks prior to screening and rhEPO use between screening and randomization (Day 1).\n * History of transfusion within the 8 weeks prior to screening and transfusion between screening and randomization (Day 1).\n * History of bone marrow aplasia or pure red cell aplasia (PRCA).\n * Subjects with Megaloblastic anemia (untreated pernicious anemia and folate deficiency), thalassemia major, sickle cell disease or myelodysplastic syndrome.\n * Evidence of actively bleeding gastric, duodenal, or esophageal ulcer disease or clinically significant gastrointestinal (GI) bleeding <= 8 weeks prior to screening through to randomization (Day 1).\n * History of severe allergic or anaphylactic reactions or hypersensitivity to excipients in the investigational product.\n * Use of strong inhibitor of CYP2C8 (for example, gemfibrozil) or strong inducers of CYP2C8 (for example, rifampin/rifampicin).\n * Ferric citrate use within 4 weeks prior to randomization (Day 1).\n * Use of another investigational agent within 30 days or within five half-lives of the investigational agent (whichever is longer) or currently participating in a study of an investigational device prior to screening through to randomization (Day 1).\n * Any prior treatment with daprodustat for a treatment duration of >30 days.\n * MI or acute coronary syndrome within the 8 weeks prior to screening through to randomization. (Day 1).\n * Stroke or transient ischemic attack within the 8 weeks prior to screening through to randomization. (Day 1).\n * Chronic Class IV heart failure, as defined by the New York Heart Association (NYHA) functional classification system.\n * QT interval corrected by Bazett's formula (QTcB) >500 milliseconds (msec) or QTcB >530 msec in subjects with bundle branch block. There is no corrected QT interval (QTc) exclusion for subjects with a predominantly paced rhythm.\n * Alanine transaminase (ALT) >2x upper limit of normal (ULN) at screening (Week -4).\n * Bilirubin >1.5xULN at screening (Week -4).\n * Current unstable liver or biliary disease per investigator assessment, generally defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis.\n * History of malignancy within the 2 years prior to screening through to randomization (Day 1), or currently receiving treatment for cancer, or complex kidney cyst (for example, Bosniak Category II F, III or IV) > 3 centimeters (cm).\n * Any other condition, clinical or laboratory abnormality, or examination finding that the investigator considers would put the subject at unacceptable risk, which may affect study compliance or prevent understanding of the aims or investigational procedures or possible consequences of the study.","EGFR","epidermal growth factor receptor","Protein","Ovary, Breast, Lung","Actual","2018-01-24","Actual","Anticipated","2020-11-05","Anticipated","2018-09-01","2018-01-08","2018-01-17","2018-09-13","No","Non-Dialysis\nAnemia\nChronic kidney disease\nRecombinant human erythropoietin naÃ¯ve\nHemoglobin\nDaprodustat","Interventional","Treatment","Parallel Assignment","Double (Participant, Investigator)","Randomized","18 Years",null,"All",null,"No","Yes\nIPD for this study will be made available via the Clinical Study Data Request site.",{"$nulls":3},"Yes","No",{"$nulls":19},"Mean change from Baseline in Hgb up to evaluation period (EP)","The EP is from Week 24 to Week 28.","Baseline and up to Week 28","Number of subjects with Hgb increase of >=1.0 grams per deciliter (g/dL) from Baseline|Mean change from Baseline in short form-36 (SF-36) questionnaire vitality domain score|Incidences and severity of adverse events (AEs) and serious AEs (SAEs)|Number of Hgb responders|Mean change from Baseline for additional Hgb parameters|Time to rescue|Mean change from Baseline in CKD - Anemia Questionnaire (CKD-AQ) score|Change from Baseline in Patient Global Impression of Severity (PGI-S) score|Change from Baseline in work productivity and daily regular activity impairment|Change from Baseline in EuroQol 5 Dimension 5 Level Health Utility Index (EQ-5D-5L) score|Change from Baseline EuroQol Visual Analogue Scale (EQ-VAS) score","Number of subjects having a Hgb increase of >=1.0 g/dL from Baseline to EP.|Mean Change in SF-36 Vitality domain score between Baseline and Week 28.|Includes AEs of special interest and adjudicated Major adverse cardiovascular event (MACE) (composite of all-cause mortality, non-fatal Myocardial infarction|Responders will be defined as subjects whose mean Hgb is within target range.|Percentage time Hgb in range and mean change in Hgb from Baseline.|Rescue is defined as permanently stopping randomized treatment due to meeting rescue criteria.|Change from Baseline to week 28 by domain and overall symptom score.|Change from Baseline to Week 28 in symptom severity score.|Change for Baseline to week 28 in mean hours work time missed on the work productivity and activity impairment (WPAI-ANS-CPV) scale.|The EQ-5D-5L is a self-reported descriptive system of health-related quality of life states consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take one of five responses. The EQ-5D-5L score ranges from 1= no problem to 5= extreme problems. A unique health state is defined by combining score from each of the five dimensions.|The EQ-VAS is a part of EQ-5D-5L heath status. The EQ VAS records the self-rated health of a subject on a 20 cm vertical, visual analogue scale. The scale ranges from 0= 'the worst health you can imagine' to 100= 'the best health you can imagine'. This instrument can be used as a quantitative measure of health as judged by the individual.","Baseline and up to Week 28|Baseline and Week 28|MI and non-fatal stroke).|Up to Week 28","GSKClinicalSupportHD@gsk.com","US GSK Clinical Trials Call Center","877-379-3718","Ciudad Autonoma De Buenos Aires, Buenos Aires, Argentina, C1128Aaf|Sydney, New South Wales, Australia, 2010|Heidelberg, Victoria, Australia, 3084|Victoria, British Columbia, Canada, V8V 4A1|Brampton, Ontario, Canada, L6T 0G1|Grenoble Cedex 9, France, 38043|Catanzaro, Calabria, Italy, 88100|Bologna, Emilia-Romagna, Italy, 40138|Pavia, Lombardia, Italy, 27100|Merida, Mexico, 97000|Guadalajara, Jalisco, Mexico, 44150|CÃ³rdoba, Veracruz, Mexico, 94550|Merida, YucatÃ¡n, Mexico, 97070|Ciechanow, Poland, 06-400|Brasov, Romania, 500283|Badalona, Spain, 08916|Canterbury, Kent, United Kingdom, Ct1 3Ng|Peterborough, United Kingdom, Pe3 9Gz|Homewood, Alabama, United States, 35209|Little Rock, Arkansas, United States, 72204|Fresno, California, United States, 93720|Middlebury, Connecticut, United States, 06762|Hollywood, Florida, United States, 33021-5424|Macon, Georgia, United States, 31217|Buckley, Michigan, United States, 49620|Saint Louis, Missouri, United States, 63136|Portsmouth, New Hampshire, United States, 03801|Asheville, North Carolina, United States, 28801|Oklahoma City, Oklahoma, United States, 73112|Beaver, Pennsylvania, United States, 15009|Orangeburg, South Carolina, United States, 29118|Desoto, Texas, United States, 75115|Norfolk, Virginia, United States, 23502","Alabama|Arkansas|California|Connecticut|Florida|Georgia|Michigan|Missouri|New Hampshire|North Carolina|Oklahoma|Pennsylvania|South Carolina|Texas|Virginia","Argentina|Australia|Canada|France|Italy|Mexico|Poland|Romania|Spain|United Kingdom|United States","Buenos Aires Gsk Investigational Site|New South Wales Gsk Investigational Site|Victoria Gsk Investigational Site|British Columbia Gsk Investigational Site|Ontario Gsk Investigational Site|Gsk Investigational Site|Calabria Gsk Investigational Site|Emilia-Romagna Gsk Investigational Site|Lombardia Gsk Investigational Site|Jalisco Gsk Investigational Site|Veracruz Gsk Investigational Site|YucatÃ¡n Gsk Investigational Site|, Kent Gsk Investigational Site",{"$nulls":3},"GSK Clinical Trials","2018-09-13","2020-05-25T16:38:27.639","2020-05-26T17:10:42.972","NCT03409107"]
["5ecbf48411702c1b1b916b3b","NCT03409107","2018-10-03","GlaxoSmithKline","GSK","Recruiting","Anemia Studies in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat in Non-Dialysis Subjects Evaluating Hemoglobin (Hgb) and Quality of Life (ASCEND-NHQ)","Daprodustat","HIF Inhibitor","Yes","['Daprodustat']","Yes","['HIF Inhibitor']","Phase 3",2,600,"Anticipated","2018-03-05","2020-11-05",{"$nulls":5},"The purpose of this multi-center study in non-dialysis subjects with anemia associated with CKD is to evaluate safety, efficacy and quality of life of daprodustat compared to placebo.",null,"A 28-week, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center, Study in Recombinant Human Erythropoietin (rhEPO) naÃ¯ve Non-dialysis Participants With Anemia Associated With Chronic Kidney Disease to Evaluate the Efficacy, Safety and Effects on Quality of Life of Daprodustat Compared to Placebo",205270,"Anaemia","Anemia|Hemoglobin C Disease|Hemoglobin SC Disease","Hematologic Diseases","Heme & Lymph Diseases","Experimental|Placebo Comparator","Daprodustat receivers|Placebo receivers","Subjects will receive oral daprodustat once daily|Subjects will receive oral placebo once daily","Drug","Daprodustat (GSK1278863)|Iron therapy|Placebo","Daprodustat will be available as 9 millimeter (mm) or 7 mm film-coated tablets. Daprodustat will be administered once daily via oral route and can be taken without regard to food.|Iron therapy will be administered if ferritin is <=50 Nano gram per milliliter and/or TSAT is <=15 percent.|Daprodustat matching placebo will be available as 9 mm or 7 mm film coated tablets. Placebo will be administered once daily via oral route and can be taken without regard to food.",null,"Daprodustat receivers|Placebo receivers","\n\n * >=18 years of age at the time of signing the informed consent.\n * Have CKD, confirmed at screening: Kidney Disease Outcomes Quality Initiative (KDOQI) CKD stages 3, 4, or 5 defined by Estimated glomerular filtration rate (eGFR) using the CKD Epidemiology Collaboration (CKD-EPI) formula.\n * Subjects with Stable HemoCue Hgb from 8.5 to 10.5 at screening visit (Week -4) and from 8.5 to 10.0 g/dL at randomization (Day 1).\n * Subjects may receive up to one intravenous (IV) iron dose within the 8 weeks prior to screening and NO IV iron use between screening visit and randomization (Day 1).\n * If needed, subject may be on stable maintenance oral iron supplementation. The type of iron and dose must not be changed for the 4 weeks prior to screening (Week -4), through the screening period, and until randomization (Day 1).\n * Male and female subjects are eligible. A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: Not a woman of childbearing potential (WOCBP) or WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 4 weeks after the last dose of study treatment.\n * Capable of giving signed informed consent.\n\n","\n\n * Subjects who are on dialysis or clinical evidence of impending need to initiate dialysis within 180 days after randomization (Day 1).\n * Planned living-related or living-unrelated kidney transplant within 28 weeks after randomization (Day 1).\n * Transferrin saturation (TSAT) <15 percent (Screening only).\n * Ferritin <50 nanograms per milliliter (ng/mL) (Screening only).\n * History of rhEPO or rhEPO analogue use within the 8 weeks prior to screening and rhEPO use between screening and randomization (Day 1).\n * History of transfusion within the 8 weeks prior to screening and transfusion between screening and randomization (Day 1).\n * History of bone marrow aplasia or pure red cell aplasia (PRCA).\n * Subjects with Megaloblastic anemia (untreated pernicious anemia and folate deficiency), thalassemia major, sickle cell disease or myelodysplastic syndrome.\n * Evidence of actively bleeding gastric, duodenal, or esophageal ulcer disease or clinically significant gastrointestinal (GI) bleeding <= 8 weeks prior to screening through to randomization (Day 1).\n * History of severe allergic or anaphylactic reactions or hypersensitivity to excipients in the investigational product.\n * Use of strong inhibitor of CYP2C8 (for example, gemfibrozil) or strong inducers of CYP2C8 (for example, rifampin/rifampicin).\n * Ferric citrate use within 4 weeks prior to randomization (Day 1).\n * Use of another investigational agent within 30 days or within five half-lives of the investigational agent (whichever is longer) or currently participating in a study of an investigational device prior to screening through to randomization (Day 1).\n * Any prior treatment with daprodustat for a treatment duration of >30 days.\n * MI or acute coronary syndrome within the 8 weeks prior to screening through to randomization. (Day 1).\n * Stroke or transient ischemic attack within the 8 weeks prior to screening through to randomization. (Day 1).\n * Chronic Class IV heart failure, as defined by the New York Heart Association (NYHA) functional classification system.\n * QT interval corrected by Bazett's formula (QTcB) >500 milliseconds (msec) or QTcB >530 msec in subjects with bundle branch block. There is no corrected QT interval (QTc) exclusion for subjects with a predominantly paced rhythm.\n * Alanine transaminase (ALT) >2x upper limit of normal (ULN) at screening (Week -4).\n * Bilirubin >1.5xULN at screening (Week -4).\n * Current unstable liver or biliary disease per investigator assessment, generally defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis.\n * History of malignancy within the 2 years prior to screening through to randomization (Day 1), or currently receiving treatment for cancer, or complex kidney cyst (for example, Bosniak Category II F, III or IV) > 3 centimeters (cm).\n * Any other condition, clinical or laboratory abnormality, or examination finding that the investigator considers would put the subject at unacceptable risk, which may affect study compliance or prevent understanding of the aims or investigational procedures or possible consequences of the study.","EGFR","epidermal growth factor receptor","Protein","Ovary, Breast, Lung","Actual","2018-01-24","Actual","Anticipated","2020-11-05","Anticipated","2018-10-01","2018-01-08","2018-01-17","2018-10-02","No","Non-Dialysis\nAnemia\nChronic kidney disease\nRecombinant human erythropoietin naÃ¯ve\nHemoglobin\nDaprodustat","Interventional","Treatment","Parallel Assignment","Double (Participant, Investigator)","Randomized","18 Years",null,"All",null,"No","Yes\nIPD for this study will be made available via the Clinical Study Data Request site.",{"$nulls":3},"Yes","No",{"$nulls":19},"Mean change from Baseline in Hgb up to evaluation period (EP)","The EP is from Week 24 to Week 28.","Baseline and up to Week 28","Number of subjects with Hgb increase of >=1.0 grams per deciliter (g/dL) from Baseline|Mean change from Baseline in short form-36 (SF-36) questionnaire vitality domain score|Incidences and severity of adverse events (AEs) and serious AEs (SAEs)|Number of Hgb responders|Mean change from Baseline for additional Hgb parameters|Time to rescue|Mean change from Baseline in CKD - Anemia Questionnaire (CKD-AQ) score|Change from Baseline in Patient Global Impression of Severity (PGI-S) score|Change from Baseline in work productivity and daily regular activity impairment|Change from Baseline in EuroQol 5 Dimension 5 Level Health Utility Index (EQ-5D-5L) score|Change from Baseline EuroQol Visual Analogue Scale (EQ-VAS) score","Number of subjects having a Hgb increase of >=1.0 g/dL from Baseline to EP.|Mean Change in SF-36 Vitality domain score between Baseline and Week 28.|Includes AEs of special interest and adjudicated Major adverse cardiovascular event (MACE) (composite of all-cause mortality, non-fatal Myocardial infarction|Responders will be defined as subjects whose mean Hgb is within target range.|Percentage time Hgb in range and mean change in Hgb from Baseline.|Rescue is defined as permanently stopping randomized treatment due to meeting rescue criteria.|Change from Baseline to week 28 by domain and overall symptom score.|Change from Baseline to Week 28 in symptom severity score.|Change for Baseline to week 28 in mean hours work time missed on the work productivity and activity impairment (WPAI-ANS-CPV) scale.|The EQ-5D-5L is a self-reported descriptive system of health-related quality of life states consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take one of five responses. The EQ-5D-5L score ranges from 1= no problem to 5= extreme problems. A unique health state is defined by combining score from each of the five dimensions.|The EQ-VAS is a part of EQ-5D-5L heath status. The EQ VAS records the self-rated health of a subject on a 20 cm vertical, visual analogue scale. The scale ranges from 0= 'the worst health you can imagine' to 100= 'the best health you can imagine'. This instrument can be used as a quantitative measure of health as judged by the individual.","Baseline and up to Week 28|Baseline and Week 28|MI and non-fatal stroke).|Up to Week 28","GSKClinicalSupportHD@gsk.com","US GSK Clinical Trials Call Center","877-379-3718","Ciudad Autonoma De Buenos Aires, Buenos Aires, Argentina, C1128Aaf|Rosario, Santa Fe, Argentina, S2000Dej|Sydney, New South Wales, Australia, 2010|Heidelberg, Victoria, Australia, 3084|Victoria, British Columbia, Canada, V8V 4A1|Brampton, Ontario, Canada, L6T 0G1|Grenoble Cedex 9, France, 38043|Catanzaro, Calabria, Italy, 88100|Bologna, Emilia-Romagna, Italy, 40138|Pavia, Lombardia, Italy, 27100|Merida, Mexico, 97000|Guadalajara, Jalisco, Mexico, 44150|CÃ³rdoba, Veracruz, Mexico, 94550|Merida, YucatÃ¡n, Mexico, 97070|Ciechanow, Poland, 06-400|Brasov, Romania, 500283|Badalona, Spain, 08916|Canterbury, Kent, United Kingdom, Ct1 3Ng|London, United Kingdom, Se5 9Rs|Homewood, Alabama, United States, 35209|Little Rock, Arkansas, United States, 72204|Fresno, California, United States, 93720|Middlebury, Connecticut, United States, 06762|Hollywood, Florida, United States, 33021-5424|Macon, Georgia, United States, 31217|Buckley, Michigan, United States, 49620|Saint Louis, Missouri, United States, 63136|Portsmouth, New Hampshire, United States, 03801|Asheville, North Carolina, United States, 28801|Oklahoma City, Oklahoma, United States, 73112|Beaver, Pennsylvania, United States, 15009|Orangeburg, South Carolina, United States, 29118|Desoto, Texas, United States, 75115|Norfolk, Virginia, United States, 23502","Alabama|Arkansas|California|Connecticut|Florida|Georgia|Michigan|Missouri|New Hampshire|North Carolina|Oklahoma|Pennsylvania|South Carolina|Texas|Virginia","Argentina|Australia|Canada|France|Italy|Mexico|Poland|Romania|Spain|United Kingdom|United States","Buenos Aires Gsk Investigational Site|Santa Fe Gsk Investigational Site|New South Wales Gsk Investigational Site|Victoria Gsk Investigational Site|British Columbia Gsk Investigational Site|Ontario Gsk Investigational Site|Gsk Investigational Site|Calabria Gsk Investigational Site|Emilia-Romagna Gsk Investigational Site|Lombardia Gsk Investigational Site|Jalisco Gsk Investigational Site|Veracruz Gsk Investigational Site|YucatÃ¡n Gsk Investigational Site|, Kent Gsk Investigational Site",{"$nulls":3},"GSK Clinical Trials","2018-10-02","2020-05-25T16:38:28.444","2020-05-26T17:10:42.972","NCT03409107"]
["5ecbf484e2561b1b11905e27","NCT03409107","2018-10-05","GlaxoSmithKline","GSK","Recruiting","Anemia Studies in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat in Non-Dialysis Subjects Evaluating Hemoglobin (Hgb) and Quality of Life (ASCEND-NHQ)","Daprodustat","HIF Inhibitor","Yes","['Daprodustat']","Yes","['HIF Inhibitor']","Phase 3",2,600,"Anticipated","2018-03-05","2020-11-05",{"$nulls":5},"The purpose of this multi-center study in non-dialysis subjects with anemia associated with CKD is to evaluate safety, efficacy and quality of life of daprodustat compared to placebo.",null,"A 28-week, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center, Study in Recombinant Human Erythropoietin (rhEPO) naÃ¯ve Non-dialysis Participants With Anemia Associated With Chronic Kidney Disease to Evaluate the Efficacy, Safety and Effects on Quality of Life of Daprodustat Compared to Placebo",205270,"Anaemia","Anemia|Hemoglobin C Disease|Hemoglobin SC Disease","Hematologic Diseases","Heme & Lymph Diseases","Experimental|Placebo Comparator","Daprodustat receivers|Placebo receivers","Subjects will receive oral daprodustat once daily|Subjects will receive oral placebo once daily","Drug","Daprodustat (GSK1278863)|Iron therapy|Placebo","Daprodustat will be available as 9 millimeter (mm) or 7 mm film-coated tablets. Daprodustat will be administered once daily via oral route and can be taken without regard to food.|Iron therapy will be administered if ferritin is <=50 Nano gram per milliliter and/or TSAT is <=15 percent.|Daprodustat matching placebo will be available as 9 mm or 7 mm film coated tablets. Placebo will be administered once daily via oral route and can be taken without regard to food.",null,"Daprodustat receivers|Placebo receivers","\n\n * >=18 years of age at the time of signing the informed consent.\n * Have CKD, confirmed at screening: Kidney Disease Outcomes Quality Initiative (KDOQI) CKD stages 3, 4, or 5 defined by Estimated glomerular filtration rate (eGFR) using the CKD Epidemiology Collaboration (CKD-EPI) formula.\n * Subjects with Stable HemoCue Hgb from 8.5 to 10.5 at screening visit (Week -4) and from 8.5 to 10.0 g/dL at randomization (Day 1).\n * Subjects may receive up to one intravenous (IV) iron dose within the 8 weeks prior to screening and NO IV iron use between screening visit and randomization (Day 1).\n * If needed, subject may be on stable maintenance oral iron supplementation. The type of iron and dose must not be changed for the 4 weeks prior to screening (Week -4), through the screening period, and until randomization (Day 1).\n * Male and female subjects are eligible. A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: Not a woman of childbearing potential (WOCBP) or WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 4 weeks after the last dose of study treatment.\n * Capable of giving signed informed consent.\n\n","\n\n * Subjects who are on dialysis or clinical evidence of impending need to initiate dialysis within 180 days after randomization (Day 1).\n * Planned living-related or living-unrelated kidney transplant within 28 weeks after randomization (Day 1).\n * Transferrin saturation (TSAT) <15 percent (Screening only).\n * Ferritin <50 nanograms per milliliter (ng/mL) (Screening only).\n * History of rhEPO or rhEPO analogue use within the 8 weeks prior to screening and rhEPO use between screening and randomization (Day 1).\n * History of transfusion within the 8 weeks prior to screening and transfusion between screening and randomization (Day 1).\n * History of bone marrow aplasia or pure red cell aplasia (PRCA).\n * Subjects with Megaloblastic anemia (untreated pernicious anemia and folate deficiency), thalassemia major, sickle cell disease or myelodysplastic syndrome.\n * Evidence of actively bleeding gastric, duodenal, or esophageal ulcer disease or clinically significant gastrointestinal (GI) bleeding <= 8 weeks prior to screening through to randomization (Day 1).\n * History of severe allergic or anaphylactic reactions or hypersensitivity to excipients in the investigational product.\n * Use of strong inhibitor of CYP2C8 (for example, gemfibrozil) or strong inducers of CYP2C8 (for example, rifampin/rifampicin).\n * Ferric citrate use within 4 weeks prior to randomization (Day 1).\n * Use of another investigational agent within 30 days or within five half-lives of the investigational agent (whichever is longer) or currently participating in a study of an investigational device prior to screening through to randomization (Day 1).\n * Any prior treatment with daprodustat for a treatment duration of >30 days.\n * MI or acute coronary syndrome within the 8 weeks prior to screening through to randomization. (Day 1).\n * Stroke or transient ischemic attack within the 8 weeks prior to screening through to randomization. (Day 1).\n * Chronic Class IV heart failure, as defined by the New York Heart Association (NYHA) functional classification system.\n * QT interval corrected by Bazett's formula (QTcB) >500 milliseconds (msec) or QTcB >530 msec in subjects with bundle branch block. There is no corrected QT interval (QTc) exclusion for subjects with a predominantly paced rhythm.\n * Alanine transaminase (ALT) >2x upper limit of normal (ULN) at screening (Week -4).\n * Bilirubin >1.5xULN at screening (Week -4).\n * Current unstable liver or biliary disease per investigator assessment, generally defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis.\n * History of malignancy within the 2 years prior to screening through to randomization (Day 1), or currently receiving treatment for cancer, or complex kidney cyst (for example, Bosniak Category II F, III or IV) > 3 centimeters (cm).\n * Any other condition, clinical or laboratory abnormality, or examination finding that the investigator considers would put the subject at unacceptable risk, which may affect study compliance or prevent understanding of the aims or investigational procedures or possible consequences of the study.","EGFR","epidermal growth factor receptor","Protein","Ovary, Breast, Lung","Actual","2018-01-24","Actual","Anticipated","2020-11-05","Anticipated","2018-10-01","2018-01-08","2018-01-17","2018-10-04","No","Non-Dialysis\nAnemia\nChronic kidney disease\nRecombinant human erythropoietin naÃ¯ve\nHemoglobin\nDaprodustat","Interventional","Treatment","Parallel Assignment","Double (Participant, Investigator)","Randomized","18 Years",null,"All",null,"No","Yes\nIPD for this study will be made available via the Clinical Study Data Request site.",{"$nulls":3},"Yes","No",{"$nulls":19},"Mean change from Baseline in Hgb up to evaluation period (EP)","The EP is from Week 24 to Week 28.","Baseline and up to Week 28","Number of subjects with Hgb increase of >=1.0 grams per deciliter (g/dL) from Baseline|Mean change from Baseline in short form-36 (SF-36) questionnaire vitality domain score|Incidences and severity of adverse events (AEs) and serious AEs (SAEs)|Number of Hgb responders|Mean change from Baseline for additional Hgb parameters|Time to rescue|Mean change from Baseline in CKD - Anemia Questionnaire (CKD-AQ) score|Change from Baseline in Patient Global Impression of Severity (PGI-S) score|Change from Baseline in work productivity and daily regular activity impairment|Change from Baseline in EuroQol 5 Dimension 5 Level Health Utility Index (EQ-5D-5L) score|Change from Baseline EuroQol Visual Analogue Scale (EQ-VAS) score","Number of subjects having a Hgb increase of >=1.0 g/dL from Baseline to EP.|Mean Change in SF-36 Vitality domain score between Baseline and Week 28.|Includes AEs of special interest and adjudicated Major adverse cardiovascular event (MACE) (composite of all-cause mortality, non-fatal Myocardial infarction|Responders will be defined as subjects whose mean Hgb is within target range.|Percentage time Hgb in range and mean change in Hgb from Baseline.|Rescue is defined as permanently stopping randomized treatment due to meeting rescue criteria.|Change from Baseline to week 28 by domain and overall symptom score.|Change from Baseline to Week 28 in symptom severity score.|Change for Baseline to week 28 in mean hours work time missed on the work productivity and activity impairment (WPAI-ANS-CPV) scale.|The EQ-5D-5L is a self-reported descriptive system of health-related quality of life states consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take one of five responses. The EQ-5D-5L score ranges from 1= no problem to 5= extreme problems. A unique health state is defined by combining score from each of the five dimensions.|The EQ-VAS is a part of EQ-5D-5L heath status. The EQ VAS records the self-rated health of a subject on a 20 cm vertical, visual analogue scale. The scale ranges from 0= 'the worst health you can imagine' to 100= 'the best health you can imagine'. This instrument can be used as a quantitative measure of health as judged by the individual.","Baseline and up to Week 28|Baseline and Week 28|MI and non-fatal stroke).|Up to Week 28","GSKClinicalSupportHD@gsk.com","US GSK Clinical Trials Call Center","877-379-3718","Ciudad Autonoma De Buenos Aires, Buenos Aires, Argentina, C1128Aaf|Rosario, Santa Fe, Argentina, S2000Dej|Sydney, New South Wales, Australia, 2010|Heidelberg, Victoria, Australia, 3084|Victoria, British Columbia, Canada, V8V 4A1|Brampton, Ontario, Canada, L6T 0G1|Grenoble Cedex 9, France, 38043|Catanzaro, Calabria, Italy, 88100|Bologna, Emilia-Romagna, Italy, 40138|Pavia, Lombardia, Italy, 27100|Merida, Mexico, 97000|Guadalajara, Jalisco, Mexico, 44150|CÃ³rdoba, Veracruz, Mexico, 94550|Merida, YucatÃ¡n, Mexico, 97070|Ciechanow, Poland, 06-400|Brasov, Romania, 500283|Badalona, Spain, 08916|Canterbury, Kent, United Kingdom, Ct1 3Ng|London, United Kingdom, Se5 9Rs|Homewood, Alabama, United States, 35209|Little Rock, Arkansas, United States, 72204|Fresno, California, United States, 93720|Middlebury, Connecticut, United States, 06762|Hollywood, Florida, United States, 33021-5424|Macon, Georgia, United States, 31217|Buckley, Michigan, United States, 49620|Saint Louis, Missouri, United States, 63136|Portsmouth, New Hampshire, United States, 03801|Asheville, North Carolina, United States, 28801|Oklahoma City, Oklahoma, United States, 73112|Beaver, Pennsylvania, United States, 15009|Orangeburg, South Carolina, United States, 29118|Desoto, Texas, United States, 75115|Norfolk, Virginia, United States, 23502","Alabama|Arkansas|California|Connecticut|Florida|Georgia|Michigan|Missouri|New Hampshire|North Carolina|Oklahoma|Pennsylvania|South Carolina|Texas|Virginia","Argentina|Australia|Canada|France|Italy|Mexico|Poland|Romania|Spain|United Kingdom|United States","Buenos Aires Gsk Investigational Site|Santa Fe Gsk Investigational Site|New South Wales Gsk Investigational Site|Victoria Gsk Investigational Site|British Columbia Gsk Investigational Site|Ontario Gsk Investigational Site|Gsk Investigational Site|Calabria Gsk Investigational Site|Emilia-Romagna Gsk Investigational Site|Lombardia Gsk Investigational Site|Jalisco Gsk Investigational Site|Veracruz Gsk Investigational Site|YucatÃ¡n Gsk Investigational Site|, Kent Gsk Investigational Site",{"$nulls":3},"GSK Clinical Trials","2018-10-04","2020-05-25T16:38:28.209","2020-05-26T17:10:42.972","NCT03409107"]
["5ecbf484e2561b1b11905e28","NCT03409107","2018-10-12","GlaxoSmithKline","GSK","Recruiting","Anemia Studies in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat in Non-Dialysis Subjects Evaluating Hemoglobin (Hgb) and Quality of Life (ASCEND-NHQ)","Daprodustat","HIF Inhibitor","Yes","['Daprodustat']","Yes","['HIF Inhibitor']","Phase 3",2,600,"Anticipated","2018-03-05","2020-11-05",{"$nulls":5},"The purpose of this multi-center study in non-dialysis subjects with anemia associated with CKD is to evaluate safety, efficacy and quality of life of daprodustat compared to placebo.",null,"A 28-week, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center, Study in Recombinant Human Erythropoietin (rhEPO) naÃ¯ve Non-dialysis Participants With Anemia Associated With Chronic Kidney Disease to Evaluate the Efficacy, Safety and Effects on Quality of Life of Daprodustat Compared to Placebo",205270,"Anaemia","Anemia|Hemoglobin C Disease|Hemoglobin SC Disease","Hematologic Diseases","Heme & Lymph Diseases","Experimental|Placebo Comparator","Daprodustat receivers|Placebo receivers","Subjects will receive oral daprodustat once daily|Subjects will receive oral placebo once daily","Drug","Daprodustat (GSK1278863)|Iron therapy|Placebo","Daprodustat will be available as 9 millimeter (mm) or 7 mm film-coated tablets. Daprodustat will be administered once daily via oral route and can be taken without regard to food.|Iron therapy will be administered if ferritin is <=50 Nano gram per milliliter and/or TSAT is <=15 percent.|Daprodustat matching placebo will be available as 9 mm or 7 mm film coated tablets. Placebo will be administered once daily via oral route and can be taken without regard to food.",null,"Daprodustat receivers|Placebo receivers","\n\n * >=18 years of age at the time of signing the informed consent.\n * Have CKD, confirmed at screening: Kidney Disease Outcomes Quality Initiative (KDOQI) CKD stages 3, 4, or 5 defined by Estimated glomerular filtration rate (eGFR) using the CKD Epidemiology Collaboration (CKD-EPI) formula.\n * Subjects with Stable HemoCue Hgb from 8.5 to 10.5 at screening visit (Week -4) and from 8.5 to 10.0 g/dL at randomization (Day 1).\n * Subjects may receive up to one intravenous (IV) iron dose within the 8 weeks prior to screening and NO IV iron use between screening visit and randomization (Day 1).\n * If needed, subject may be on stable maintenance oral iron supplementation. The type of iron and dose must not be changed for the 4 weeks prior to screening (Week -4), through the screening period, and until randomization (Day 1).\n * Male and female subjects are eligible. A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: Not a woman of childbearing potential (WOCBP) or WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 4 weeks after the last dose of study treatment.\n * Capable of giving signed informed consent.\n\n","\n\n * Subjects who are on dialysis or clinical evidence of impending need to initiate dialysis within 180 days after randomization (Day 1).\n * Planned living-related or living-unrelated kidney transplant within 28 weeks after randomization (Day 1).\n * Transferrin saturation (TSAT) <15 percent (Screening only).\n * Ferritin <50 nanograms per milliliter (ng/mL) (Screening only).\n * History of rhEPO or rhEPO analogue use within the 8 weeks prior to screening and rhEPO use between screening and randomization (Day 1).\n * History of transfusion within the 8 weeks prior to screening and transfusion between screening and randomization (Day 1).\n * History of bone marrow aplasia or pure red cell aplasia (PRCA).\n * Subjects with Megaloblastic anemia (untreated pernicious anemia and folate deficiency), thalassemia major, sickle cell disease or myelodysplastic syndrome.\n * Evidence of actively bleeding gastric, duodenal, or esophageal ulcer disease or clinically significant gastrointestinal (GI) bleeding <= 8 weeks prior to screening through to randomization (Day 1).\n * History of severe allergic or anaphylactic reactions or hypersensitivity to excipients in the investigational product.\n * Use of strong inhibitor of CYP2C8 (for example, gemfibrozil) or strong inducers of CYP2C8 (for example, rifampin/rifampicin).\n * Ferric citrate use within 4 weeks prior to randomization (Day 1).\n * Use of another investigational agent within 30 days or within five half-lives of the investigational agent (whichever is longer) or currently participating in a study of an investigational device prior to screening through to randomization (Day 1).\n * Any prior treatment with daprodustat for a treatment duration of >30 days.\n * MI or acute coronary syndrome within the 8 weeks prior to screening through to randomization. (Day 1).\n * Stroke or transient ischemic attack within the 8 weeks prior to screening through to randomization. (Day 1).\n * Chronic Class IV heart failure, as defined by the New York Heart Association (NYHA) functional classification system.\n * QT interval corrected by Bazett's formula (QTcB) >500 milliseconds (msec) or QTcB >530 msec in subjects with bundle branch block. There is no corrected QT interval (QTc) exclusion for subjects with a predominantly paced rhythm.\n * Alanine transaminase (ALT) >2x upper limit of normal (ULN) at screening (Week -4).\n * Bilirubin >1.5xULN at screening (Week -4).\n * Current unstable liver or biliary disease per investigator assessment, generally defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis.\n * History of malignancy within the 2 years prior to screening through to randomization (Day 1), or currently receiving treatment for cancer, or complex kidney cyst (for example, Bosniak Category II F, III or IV) > 3 centimeters (cm).\n * Any other condition, clinical or laboratory abnormality, or examination finding that the investigator considers would put the subject at unacceptable risk, which may affect study compliance or prevent understanding of the aims or investigational procedures or possible consequences of the study.","EGFR","epidermal growth factor receptor","Protein","Ovary, Breast, Lung","Actual","2018-01-24","Actual","Anticipated","2020-11-05","Anticipated","2018-10-01","2018-01-08","2018-01-17","2018-10-11","No","Non-Dialysis\nAnemia\nChronic kidney disease\nRecombinant human erythropoietin naÃ¯ve\nHemoglobin\nDaprodustat","Interventional","Treatment","Parallel Assignment","Double (Participant, Investigator)","Randomized","18 Years",null,"All",null,"No","Yes\nIPD for this study will be made available via the Clinical Study Data Request site.",{"$nulls":3},"Yes","No",{"$nulls":19},"Mean change from Baseline in Hgb up to evaluation period (EP)","The EP is from Week 24 to Week 28.","Baseline and up to Week 28","Number of subjects with Hgb increase of >=1.0 grams per deciliter (g/dL) from Baseline|Mean change from Baseline in short form-36 (SF-36) questionnaire vitality domain score|Incidences and severity of adverse events (AEs) and serious AEs (SAEs)|Number of Hgb responders|Mean change from Baseline for additional Hgb parameters|Time to rescue|Mean change from Baseline in CKD - Anemia Questionnaire (CKD-AQ) score|Change from Baseline in Patient Global Impression of Severity (PGI-S) score|Change from Baseline in work productivity and daily regular activity impairment|Change from Baseline in EuroQol 5 Dimension 5 Level Health Utility Index (EQ-5D-5L) score|Change from Baseline EuroQol Visual Analogue Scale (EQ-VAS) score","Number of subjects having a Hgb increase of >=1.0 g/dL from Baseline to EP.|Mean Change in SF-36 Vitality domain score between Baseline and Week 28.|Includes AEs of special interest and adjudicated Major adverse cardiovascular event (MACE) (composite of all-cause mortality, non-fatal Myocardial infarction|Responders will be defined as subjects whose mean Hgb is within target range.|Percentage time Hgb in range and mean change in Hgb from Baseline.|Rescue is defined as permanently stopping randomized treatment due to meeting rescue criteria.|Change from Baseline to week 28 by domain and overall symptom score.|Change from Baseline to Week 28 in symptom severity score.|Change for Baseline to week 28 in mean hours work time missed on the work productivity and activity impairment (WPAI-ANS-CPV) scale.|The EQ-5D-5L is a self-reported descriptive system of health-related quality of life states consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take one of five responses. The EQ-5D-5L score ranges from 1= no problem to 5= extreme problems. A unique health state is defined by combining score from each of the five dimensions.|The EQ-VAS is a part of EQ-5D-5L heath status. The EQ VAS records the self-rated health of a subject on a 20 cm vertical, visual analogue scale. The scale ranges from 0= 'the worst health you can imagine' to 100= 'the best health you can imagine'. This instrument can be used as a quantitative measure of health as judged by the individual.","Baseline and up to Week 28|Baseline and Week 28|MI and non-fatal stroke).|Up to Week 28","GSKClinicalSupportHD@gsk.com","US GSK Clinical Trials Call Center","877-379-3718","Ciudad Autonoma De Buenos Aires, Buenos Aires, Argentina, C1128Aaf|Rosario, Santa Fe, Argentina, S2000Dej|Sydney, New South Wales, Australia, 2010|Heidelberg, Victoria, Australia, 3084|SÃ£o Bernardo Do Campo, SÃ£o Paulo, Brazil, 09715090|Victoria, British Columbia, Canada, V8V 4A1|Brampton, Ontario, Canada, L6T 0G1|Grenoble Cedex 9, France, 38043|Catanzaro, Calabria, Italy, 88100|Bologna, Emilia-Romagna, Italy, 40138|Pavia, Lombardia, Italy, 27100|Merida, Mexico, 97000|Guadalajara, Jalisco, Mexico, 44150|CÃ³rdoba, Veracruz, Mexico, 94550|Merida, YucatÃ¡n, Mexico, 97070|Ciechanow, Poland, 06-400|Brasov, Romania, 500283|Badalona, Spain, 08916|Canterbury, Kent, United Kingdom, Ct1 3Ng|London, United Kingdom, Se5 9Rs|Homewood, Alabama, United States, 35209|Little Rock, Arkansas, United States, 72204|Fresno, California, United States, 93720|Middlebury, Connecticut, United States, 06762|Hollywood, Florida, United States, 33021-5424|Macon, Georgia, United States, 31217|Buckley, Michigan, United States, 49620|Saint Louis, Missouri, United States, 63136|Portsmouth, New Hampshire, United States, 03801|Asheville, North Carolina, United States, 28801|Oklahoma City, Oklahoma, United States, 73112|Beaver, Pennsylvania, United States, 15009|Orangeburg, South Carolina, United States, 29118|Desoto, Texas, United States, 75115|Norfolk, Virginia, United States, 23502","Alabama|Arkansas|California|Connecticut|Florida|Georgia|Michigan|Missouri|New Hampshire|North Carolina|Oklahoma|Pennsylvania|South Carolina|Texas|Virginia","Argentina|Australia|Brazil|Canada|France|Italy|Mexico|Poland|Romania|Spain|United Kingdom|United States","Buenos Aires Gsk Investigational Site|Santa Fe Gsk Investigational Site|New South Wales Gsk Investigational Site|Victoria Gsk Investigational Site|SÃ£o Paulo Gsk Investigational Site|British Columbia Gsk Investigational Site|Ontario Gsk Investigational Site|Gsk Investigational Site|Calabria Gsk Investigational Site|Emilia-Romagna Gsk Investigational Site|Lombardia Gsk Investigational Site|Jalisco Gsk Investigational Site|Veracruz Gsk Investigational Site|YucatÃ¡n Gsk Investigational Site|, Kent Gsk Investigational Site",{"$nulls":3},"GSK Clinical Trials","2018-10-11","2020-05-25T16:38:28.599","2020-05-26T17:10:42.972","NCT03409107"]
["5ecbf48511702c1b1b916b3c","NCT03409107","2019-08-09","GlaxoSmithKline","GSK","Recruiting","Anemia Studies in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat in Non-Dialysis Subjects Evaluating Hemoglobin (Hgb) and Quality of Life (ASCEND-NHQ)","Daprodustat","HIF Inhibitor","Yes","['Daprodustat']","Yes","['HIF Inhibitor']","Phase 3",2,600,"Anticipated","2018-03-05","2020-11-05",{"$nulls":5},"The purpose of this multi-center study in non-dialysis subjects with anemia associated with CKD is to evaluate safety, efficacy and quality of life of daprodustat compared to placebo.",null,"A 28-week, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center, Study in Recombinant Human Erythropoietin (rhEPO) naÃ¯ve Non-dialysis Participants With Anemia Associated With Chronic Kidney Disease to Evaluate the Efficacy, Safety and Effects on Quality of Life of Daprodustat Compared to Placebo",205270,"Anaemia","Anemia|Hemoglobin C Disease|Hemoglobin SC Disease","Hematologic Diseases","Heme & Lymph Diseases","Experimental|Placebo Comparator","Daprodustat receivers|Placebo receivers","Subjects will receive oral daprodustat once daily|Subjects will receive oral placebo once daily","Drug","Daprodustat (GSK1278863)|Iron therapy|Placebo","Daprodustat will be available as 9 millimeter (mm) or 7 mm film-coated tablets. Daprodustat will be administered once daily via oral route and can be taken without regard to food.|Iron therapy will be administered if ferritin is <=50 Nano gram per milliliter and/or TSAT is <=15 percent.|Daprodustat matching placebo will be available as 9 mm or 7 mm film coated tablets. Placebo will be administered once daily via oral route and can be taken without regard to food.",null,"Daprodustat receivers|Placebo receivers","\n\n * >=18 years of age at the time of signing the informed consent.\n * Have CKD, confirmed at screening: Kidney Disease Outcomes Quality Initiative (KDOQI) CKD stages 3, 4, or 5 defined by Estimated glomerular filtration rate (eGFR) using the CKD Epidemiology Collaboration (CKD-EPI) formula.\n * Subjects with Stable HemoCue Hgb from 8.5 to 10.5 at screening visit (Week -4) and from 8.5 to 10.0 g/dL at randomization (Day 1).\n * Subjects may receive up to one intravenous (IV) iron dose within the 8 weeks prior to screening and NO IV iron use between screening visit and randomization (Day 1).\n * If needed, subject may be on stable maintenance oral iron supplementation. The type of iron and dose must not be changed for the 4 weeks prior to screening (Week -4), through the screening period, and until randomization (Day 1).\n * Male and female subjects are eligible. A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: Not a woman of childbearing potential (WOCBP) or WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 4 weeks after the last dose of study treatment.\n * Capable of giving signed informed consent.\n\n","\n\n * Subjects who are on dialysis or clinical evidence of impending need to initiate dialysis within 180 days after randomization (Day 1).\n * Planned living-related or living-unrelated kidney transplant within 28 weeks after randomization (Day 1).\n * Transferrin saturation (TSAT) <15 percent (Screening only).\n * Ferritin <50 nanograms per milliliter (ng/mL) (Screening only).\n * History of rhEPO or rhEPO analogue use within the 8 weeks prior to screening and rhEPO use between screening and randomization (Day 1).\n * History of transfusion within the 8 weeks prior to screening and transfusion between screening and randomization (Day 1).\n * History of bone marrow aplasia or pure red cell aplasia (PRCA).\n * Subjects with Megaloblastic anemia (untreated pernicious anemia and folate deficiency), thalassemia major, sickle cell disease or myelodysplastic syndrome.\n * Evidence of actively bleeding gastric, duodenal, or esophageal ulcer disease or clinically significant gastrointestinal (GI) bleeding <= 8 weeks prior to screening through to randomization (Day 1).\n * History of severe allergic or anaphylactic reactions or hypersensitivity to excipients in the investigational product.\n * Use of strong inhibitor of CYP2C8 (for example, gemfibrozil) or strong inducers of CYP2C8 (for example, rifampin/rifampicin).\n * Ferric citrate use within 4 weeks prior to randomization (Day 1).\n * Use of another investigational agent within 30 days or within five half-lives of the investigational agent (whichever is longer) or currently participating in a study of an investigational device prior to screening through to randomization (Day 1).\n * Any prior treatment with daprodustat for a treatment duration of >30 days.\n * MI or acute coronary syndrome within the 8 weeks prior to screening through to randomization. (Day 1).\n * Stroke or transient ischemic attack within the 8 weeks prior to screening through to randomization. (Day 1).\n * Chronic Class IV heart failure, as defined by the New York Heart Association (NYHA) functional classification system.\n * QT interval corrected by Bazett's formula (QTcB) >500 milliseconds (msec) or QTcB >530 msec in subjects with bundle branch block. There is no corrected QT interval (QTc) exclusion for subjects with a predominantly paced rhythm.\n * Alanine transaminase (ALT) >2x upper limit of normal (ULN) at screening (Week -4).\n * Bilirubin >1.5xULN at screening (Week -4).\n * Current unstable liver or biliary disease per investigator assessment, generally defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis.\n * History of malignancy within the 2 years prior to screening through to randomization (Day 1), or currently receiving treatment for cancer, or complex kidney cyst (for example, Bosniak Category II F, III or IV) > 3 centimeters (cm).\n * Any other condition, clinical or laboratory abnormality, or examination finding that the investigator considers would put the subject at unacceptable risk, which may affect study compliance or prevent understanding of the aims or investigational procedures or possible consequences of the study.","EGFR","epidermal growth factor receptor","Protein","Ovary, Breast, Lung","Actual","2018-01-24","Actual","Anticipated","2020-11-05","Anticipated","2019-08-01","2018-01-08","2018-01-17","2019-08-08","No","Non-Dialysis\nAnemia\nChronic kidney disease\nRecombinant human erythropoietin naÃ¯ve\nHemoglobin\nDaprodustat","Interventional","Treatment","Parallel Assignment","Double (Participant, Investigator)","Randomized","18 Years",null,"All",null,"No","Yes\nIPD for this study will be made available via the Clinical Study Data Request site.",{"$nulls":3},"Yes","No",{"$nulls":17},"2017-002270-39","EudraCT Number","Mean change from Baseline in Hgb up to evaluation period (EP)","The EP is from Week 24 to Week 28.","Baseline and up to Week 28","Number of subjects with Hgb increase of >=1.0 grams per deciliter (g/dL) from Baseline|Mean change from Baseline in short form-36 (SF-36) questionnaire vitality domain score|Incidences and severity of adverse events (AEs) and serious AEs (SAEs)|Number of Hgb responders|Mean change from Baseline for additional Hgb parameters|Time to rescue|Mean change from Baseline in CKD - Anemia Questionnaire (CKD-AQ) score|Change from Baseline in Patient Global Impression of Severity (PGI-S) score|Change from Baseline in work productivity and daily regular activity impairment|Change from Baseline in EuroQol 5 Dimension 5 Level Health Utility Index (EQ-5D-5L) score|Change from Baseline EuroQol Visual Analogue Scale (EQ-VAS) score","Number of subjects having a Hgb increase of >=1.0 g/dL from Baseline to EP.|Mean Change in SF-36 Vitality domain score between Baseline and Week 28.|Includes AEs of special interest and adjudicated Major adverse cardiovascular event (MACE) (composite of all-cause mortality, non-fatal Myocardial infarction|Responders will be defined as subjects whose mean Hgb is within target range.|Percentage time Hgb in range and mean change in Hgb from Baseline.|Rescue is defined as permanently stopping randomized treatment due to meeting rescue criteria.|Change from Baseline to week 28 by domain and overall symptom score.|Change from Baseline to Week 28 in symptom severity score.|Change for Baseline to week 28 in mean hours work time missed on the work productivity and activity impairment (WPAI-ANS-CPV) scale.|The EQ-5D-5L is a self-reported descriptive system of health-related quality of life states consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take one of five responses. The EQ-5D-5L score ranges from 1= no problem to 5= extreme problems. A unique health state is defined by combining score from each of the five dimensions.|The EQ-VAS is a part of EQ-5D-5L heath status. The EQ VAS records the self-rated health of a subject on a 20 cm vertical, visual analogue scale. The scale ranges from 0= 'the worst health you can imagine' to 100= 'the best health you can imagine'. This instrument can be used as a quantitative measure of health as judged by the individual.","Baseline and up to Week 28|Baseline and Week 28|MI and non-fatal stroke).|Up to Week 28","GSKClinicalSupportHD@gsk.com","US GSK Clinical Trials Call Center","877-379-3718","Ciudad Autonoma De Buenos Aires, Buenos Aires, Argentina, C1128Aaf|CÃ³rdoba, CÃ³rdova, Argentina, X5000Ave|Santa Fe, Argentina, 3000|Rosario, Santa Fe, Argentina, S2000Dej|Fitzroy, Australia, 3065|Murdoch, Western|Sydney, New South Wales, Australia, 2010|Heidelberg, Victoria, Australia, 3084|Feira De Santana., Bahia, Brazil, 44001-584|Vitoria, EspÃ­rito Santo, Brazil, 29055450|Sao Jose Do Rio Preto, Brazil, 15090-000|Botucatu, SÃ£o Paulo, Brazil, 18618686|Victoria, British Columbia, Canada, V8V 4A1|Quebec, Canada, G3K 2P8|Brampton, Ontario, Canada, L6T 0G1|MontrÃ©al, Quebec, Canada, H1M 1B1|Grenoble Cedex 9, France, 38043|Veracruz, Mexico, 91900|Catanzaro, Calabria, Italy, 88100|Napoli, Campania, Italy, 80131|Bologna, Emilia-Romagna, Italy, 40138|Genova, Liguria, Italy, 16132|Pavia, Lombardia, Italy, 27100|Mestre, Veneto, Italy, 30174|Guadalajara, Mexico, 44600|Leon, Guanajuato, Mexico, 37390|Guadalajara, Jalisco, Mexico, 44150|Monterrey, Nuevo LeÃ³n, Mexico, 64060|CÃ³rdoba, Veracruz, Mexico, 94550|Merida, YucatÃ¡n, Mexico, 97070|Ciechanow, Poland, 06-400|Brasov, Romania, 500283|Badalona, Spain, 08916 Gsk Investigational SiteMadrid, Spain, 28040|Canterbury, Kent, United Kingdom, Ct1 3Ng|Derby, United Kingdom, De22 3Ne|Homewood, Alabama, United States, 35209|Little Rock, Arkansas, United States, 72204|Fresno, California, United States, 93720|Denver, Colorado, United States, 80218|Hartford, Connecticut, United States, 06112|Coral Springs, Florida, United States, 33067|Adairsville, Georgia, United States, 30103|Indianapolis, Indiana, United States, 46260|Overland Park, Kansas, United States, 66210|Buckley, Michigan, United States, 49620|Saint Louis, Missouri, United States, 63136|Portsmouth, New Hampshire, United States, 03801|Asheville, North Carolina, United States, 28801 Gsk Investigational SiteCharlotte, North Carolina, United States, 28262|Oklahoma City, Oklahoma, United States, 73112|Beaver, Pennsylvania, United States, 15009|Orangeburg, South Carolina, United States, 29118|Kingsport, Tennessee, United States, 37660|Desoto, Texas, United States, 75115|Norfolk, Virginia, United States, 23502","Alabama|Arkansas|California|Colorado|Connecticut|Florida|Georgia|Indiana|Kansas|Michigan|Missouri|New Hampshire|North Carolina|Oklahoma|Pennsylvania|South Carolina|Tennessee|Texas|Virginia","Argentina|Australia|Brazil|Canada|France|Israel|Italy|Mexico|Poland|Romania|Spain|United Kingdom|United States","Buenos Aires Gsk Investigational Site|CÃ³rdova Gsk Investigational Site|Gsk Investigational Site|Santa Fe Gsk Investigational Site|New South Wales Gsk Investigational Site|Victoria Gsk Investigational Site|Bahia Gsk Investigational Site|EspÃ­rito Santo Gsk Investigational Site|SÃ£o Paulo Gsk Investigational Site|British Columbia Gsk Investigational Site|Ontario Gsk Investigational Site|Quebec Gsk Investigational Site|Salas-Nolasco Gsk Investigational Site|Calabria Gsk Investigational Site|Campania Gsk Investigational Site|Emilia-Romagna Gsk Investigational Site|Liguria Gsk Investigational Site|Lombardia Gsk Investigational Site|Veneto Gsk Investigational Site|Guanajuato Gsk Investigational Site|Jalisco Gsk Investigational Site|Nuevo LeÃ³n Gsk Investigational Site|Veracruz Gsk Investigational Site|YucatÃ¡n Gsk Investigational Site|, Kent Gsk Investigational Site","GSKClinicalSupportHD@gsk.com","EU GSK Clinical Trials Call Center","+44 (0) 20 89904466","GSK Clinical Trials","2019-08-08","2020-05-25T16:38:29.063","2020-05-26T17:10:42.972","NCT03409107"]
["5ecbf485fe30261b1a04832f","NCT03409107","2019-12-10","GlaxoSmithKline","GSK","Recruiting","Anemia Studies in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat in Non-Dialysis Subjects Evaluating Hemoglobin (Hgb) and Quality of Life (ASCEND-NHQ)","Daprodustat","HIF Inhibitor","Yes","['Daprodustat']","Yes","['HIF Inhibitor']","Phase 3",2,600,"Anticipated","2018-03-05","2020-11-05",{"$nulls":5},"The purpose of this multi-center study in non-dialysis participants with anemia associated with CKD is to evaluate safety, efficacy and quality of life of daprodustat compared to placebo.",null,"A 28-week, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center, Study in Recombinant Human Erythropoietin (rhEPO) naÃ¯ve Non-dialysis Participants With Anemia Associated With Chronic Kidney Disease to Evaluate the Efficacy, Safety and Effects on Quality of Life of Daprodustat Compared to Placebo",205270,"Anaemia","Anemia|Hemoglobin C Disease|Hemoglobin SC Disease","Hematologic Diseases","Heme & Lymph Diseases","Experimental|Placebo Comparator","Daprodustat receivers|Placebo receivers","Participants will receive oral daprodustat once daily|Participants will receive oral placebo once daily","Drug","Daprodustat (GSK1278863)|Iron therapy|Placebo","Daprodustat will be available as 9 millimeter (mm) or 7 mm film-coated tablets. Daprodustat will be administered once daily via oral route and can be taken without regard to food.|Iron therapy will be administered if ferritin is <50 Nano gram per milliliter and/or TSAT is <15 percent.|Daprodustat matching placebo will be available as 9 mm or 7 mm film coated tablets. Placebo will be administered once daily via oral route and can be taken without regard to food.",null,"Daprodustat receivers|Placebo receivers","\n\n * >=18 years of age at the time of signing the informed consent.\n * Have CKD, confirmed at screening: Kidney Disease Outcomes Quality Initiative (KDOQI) CKD stages 3, 4, or 5 defined by Estimated glomerular filtration rate (eGFR) using the CKD Epidemiology Collaboration (CKD-EPI) formula.\n * Participants with Stable HemoCue Hgb from 8.5 to 10.5 at screening visit (Week -4) and from 8.5 to 10.0 g/dL at randomization (Day 1).\n * Participants may receive up to one intravenous (IV) iron dose within the 8 weeks prior to screening and NO IV iron use between screening visit and randomization (Day 1).\n * If needed, participant may be on stable maintenance oral iron supplementation. There should be <50% change in overall dose and no change in type of iron prescribed in the 4 weeks prior to Day 1 randomization visit.\n * Male and female participants are eligible. A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: Not a woman of childbearing potential (WOCBP) or WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 4 weeks after the last dose of study treatment.\n * Capable of giving signed informed consent.\n\n","\n\n * Participants who are on dialysis or clinical evidence of impending need to initiate dialysis within 180 days after randomization (Day 1).\n * Planned living-related or living-unrelated kidney transplant within 28 weeks after randomization (Day 1).\n * Transferrin saturation (TSAT) <15 percent (Screening only).\n * Ferritin <50 nanograms per milliliter (ng/mL) (Screening only).\n * History of rhEPO or rhEPO analogue use within the 8 weeks prior to screening and rhEPO use between screening and randomization (Day 1).\n * History of transfusion within the 8 weeks prior to screening and transfusion between screening and randomization (Day 1).\n * History of bone marrow aplasia or pure red cell aplasia (PRCA).\n * Participants with Megaloblastic anemia (untreated pernicious anemia and folate deficiency), thalassemia major, sickle cell disease or myelodysplastic syndrome.\n * Evidence of actively bleeding gastric, duodenal, or esophageal ulcer disease or clinically significant gastrointestinal (GI) bleeding <= 8 weeks prior to screening through to randomization (Day 1).\n * History of severe allergic or anaphylactic reactions or hypersensitivity to excipients in the investigational product.\n * Use of strong inhibitor of CYP2C8 (for example, gemfibrozil) or strong inducers of CYP2C8 (for example, rifampin/rifampicin).\n * Ferric citrate use within 4 weeks prior to randomization (Day 1).\n * Use of other investigational agent or device prior to screening through to randomization (Day 1).\n * Any prior treatment with daprodustat for a treatment duration of >30 days.\n * MI or acute coronary syndrome within the 8 weeks prior to screening through to randomization. (Day 1).\n * Stroke or transient ischemic attack within the 8 weeks prior to screening through to randomization. (Day 1).\n * Chronic Class IV heart failure, as defined by the New York Heart Association (NYHA) functional classification system.\n * QT interval corrected by Bazett's formula (QTcB) >500 milliseconds (msec) or QTcB >530 msec in participants with bundle branch block. There is no corrected QT interval (QTc) exclusion for participants with a predominantly paced rhythm.\n * Alanine transaminase (ALT) >2x upper limit of normal (ULN) at screening (Week -4).\n * Bilirubin >1.5xULN at screening (Week -4).\n * Current unstable liver or biliary disease per investigator assessment, generally defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis.\n * History of malignancy within the 2 years prior to screening through to randomization (Day 1), or currently receiving treatment for cancer, or complex kidney cyst (for example, Bosniak Category II F, III or IV) > 3 centimeters (cm).\n * Any other condition, clinical or laboratory abnormality, or examination finding that the investigator considers would put the participant at unacceptable risk, which may affect study compliance or prevent understanding of the aims or investigational procedures or possible consequences of the study.\n * Current uncontrolled hypertension as determined by the investigator.","EGFR","epidermal growth factor receptor","Protein","Ovary, Breast, Lung","Actual","2018-01-24","Actual","Anticipated","2020-11-05","Anticipated","2019-12-01","2018-01-08","2018-01-17","2019-12-06","No","Non-Dialysis\nAnemia\nChronic kidney disease\nRecombinant human erythropoietin naÃ¯ve\nHemoglobin\nDaprodustat","Interventional","Treatment","Parallel Assignment","Double (Participant, Investigator)","Randomized","18 Years",null,"All",null,"No","Yes\nIPD for this study will be made available via the Clinical Study Data Request site.",{"$nulls":3},"Yes","No",{"$nulls":17},"2017-002270-39","EudraCT Number","Mean change from Baseline in Hgb up to evaluation period (EP)","The EP is from Week 24 to Week 28.","Baseline and up to Week 28","Percentage of participants with Hgb increase of >=1.0 grams per deciliter (g/dL) from Baseline|Mean change from Baseline in short form-36 (SF-36) questionnaire vitality domain score|Percentage of Hgb responders|Percentage time Hgb in range|Mean change from Baseline for additional Hgb parameters|Time to rescue|Mean change from Baseline in CKD - Anemia Questionnaire (CKD-AQ) score|Change from Baseline in Patient Global Impression of Severity (PGI-S) score|Mean change from Baseline in SF-36 questionnaire vitality domain score|Mean change from Baseline in SF-36 questionnaire physical function domain score|Percentage of participants currently employed on the work productivity and activity impairment, anemia symptoms, clinical practice version (WPAI-ANS-CPV) scale|Change from Baseline in percent mean hours work time missed on the WPAI-ANS|CPV change from Baseline in percent impaired on the WPAI-ANS-CPV questionnaire|Change from Baseline in overall percent work impairment on the WPAI-ANS-CPV questionnaire|Change from Baseline in percent activity impairment on the WPAI-ANS-CPV questionnaire|Change from Baseline in EuroQol 5 Dimension 5 Level Health Utility Index (EQ-5D-5L) score|Change from Baseline EuroQol Visual Analogue Scale (EQ-VAS) score|Change from Baseline in systolic blood pressure (SBP), diastolic blood pressure (DBP) and mean arterial pressure (MAP) at Week 28|Percentage of participants with at least one BP exacerbation|Other Pre-specified Outcome Measures:|Incidences and severity of adverse events (AEs) and serious AEs (SAEs)","Percentage (%) of participants having a Hgb increase of >=1.0 g/dL from Baseline to EP.|Mean Change in SF-36 Vitality domain score between Baseline and Week 28.|Responders will be defined as percentage of participants whose mean Hgb is within target range.|Percentage time of Hgb within the target range will be analyzed.|Mean change in Hgb from Baseline to Week 28.|Time to rescue is defined as time to permanently stopping randomized treatment due to meeting rescue criteria.|Mean change from Baseline to week 28 by domain and overall symptom score on the CKD-AQ symptom questionnaire.|Change from Baseline to Week 28 in the severity and change in symptoms by PGI-S score.|Mean Change in individual items of the SF-36 vitality domain score between Baseline and Week 28 will be analyzed.|Mean Change in SF-36 physical function domain score between Baseline and Week 28 will be analyzed.|Percentage of participants currently employed on WPAI-ANS-CPV; questionnaire will be analyzed.|Change from Baseline in percent mean hours work time missed using WPAI-ANS-CPV questionnaire will be analyzed.|CPV change from Baseline in percent impaired on the WPAI-ANS-CPV questionnaire will be analyzed.|Change from Baseline in overall percent work impairment using the WPAI-ANS-CPV questionnaire will be analyzed.|Change from Baseline in percent activity impairment using WPAI-ANS-CPV will be analyzed.|Change from Baseline to Week 28 in health status by EQ-5D-5L score.|Change from Baseline to Week 28 in EQ-VAS score.|Change from Baseline in SBP, DBP and MAP at Week 28 will be analyzed.|Percentage of participants with at least one BP exacerbation during the study will be analyzed.|Other Pre-specified Outcome Measures:|Includes AEs of special interest and adjudicated Major adverse cardiovascular event (MACE) (composite of all-cause mortality, non-fatal Myocardial infarction","Baseline and up to Week 28|Baseline and Week 28|Up to Week 28|Baseline and at Week 28|MI and non-fatal stroke).","GSKClinicalSupportHD@gsk.com","US GSK Clinical Trials Call Center","877-379-3718","Ciudad Autonoma De Buenos Aires, Buenos Aires, Argentina, C1128Aaf|Cordoba, CÃ³rdova, Argentina, 5003|Santa Fe, Argentina, 3000|Rosario, Santa Fe, Argentina, S2000Dej|Fitzroy, Australia, 3065|Murdoch, Western|Sydney, New South Wales, Australia, 2010|Heidelberg, Victoria, Australia, 3084|Feira De Santana., Bahia, Brazil, 44001-584|Vitoria, EspÃ­rito Santo, Brazil, 29055450|SÃ£o Paulo, Brazil, 04038002|RibeirÃ£o Preto, SÃ£o Paulo, Brazil, 14025170|Victoria, British Columbia, Canada, V8V 4A1|Quebec, Canada, G3K 2P8|Brampton, Ontario, Canada, L6T 0G1|MontrÃ©al, Quebec, Canada, H1M 1B1|Grenoble Cedex 9, France, 38043|Veracruz, Mexico, 91900|Catanzaro, Calabria, Italy, 88100|Napoli, Campania, Italy, 80131|Bologna, Emilia-Romagna, Italy, 40138|Genova, Liguria, Italy, 16132|Pavia, Lombardia, Italy, 27100|Mestre, Veneto, Italy, 30174|Guadalajara, Mexico, 44600|Leon, Guanajuato, Mexico, 37390|Guadalajara, Jalisco, Mexico, 44150|Monterrey, Nuevo LeÃ³n, Mexico, 64060|CÃ³rdoba, Veracruz, Mexico, 94550|Merida, YucatÃ¡n, Mexico, 97070|Ciechanow, Poland, 06-400|Brasov, Romania, 500283|Badalona, Spain, 08916 Gsk Investigational SiteMadrid, Spain, 28040|Canterbury, Kent, United Kingdom, Ct1 3Ng|Derby, United Kingdom, De22 3Ne|Homewood, Alabama, United States, 35209|Little Rock, Arkansas, United States, 72204|Fresno, California, United States, 93720|Denver, Colorado, United States, 80218|Hartford, Connecticut, United States, 06112|Coral Springs, Florida, United States, 33067|Adairsville, Georgia, United States, 30103|Indianapolis, Indiana, United States, 46260|Overland Park, Kansas, United States, 66210|Buckley, Michigan, United States, 49620|Brookhaven, Mississippi, United States, 39601|Saint Louis, Missouri, United States, 63136|Portsmouth, New Hampshire, United States, 03801|Asheville, North Carolina, United States, 28801 Gsk Investigational SiteCharlotte, North Carolina, United States, 28262 Gsk Investigational SiteDurham, North Carolina, United States, 27704|Midwest City, Oklahoma, United States, 73130|Beaver, Pennsylvania, United States, 15009|Orangeburg, South Carolina, United States, 29118|Kingsport, Tennessee, United States, 37660|Desoto, Texas, United States, 75115|Norfolk, Virginia, United States, 23502","Alabama|Arkansas|California|Colorado|Connecticut|Florida|Georgia|Indiana|Kansas|Michigan|Mississippi|Missouri|New Hampshire|North Carolina|Oklahoma|Pennsylvania|South Carolina|Tennessee|Texas|Virginia","Argentina|Australia|Brazil|Canada|France|Israel|Italy|Mexico|Poland|Romania|Spain|United Kingdom|United States","Buenos Aires Gsk Investigational Site|CÃ³rdova Gsk Investigational Site|Gsk Investigational Site|Santa Fe Gsk Investigational Site|New South Wales Gsk Investigational Site|Victoria Gsk Investigational Site|Bahia Gsk Investigational Site|EspÃ­rito Santo Gsk Investigational Site|SÃ£o Paulo Gsk Investigational Site|British Columbia Gsk Investigational Site|Ontario Gsk Investigational Site|Quebec Gsk Investigational Site|Salas-Nolasco Gsk Investigational Site|Calabria Gsk Investigational Site|Campania Gsk Investigational Site|Emilia-Romagna Gsk Investigational Site|Liguria Gsk Investigational Site|Lombardia Gsk Investigational Site|Veneto Gsk Investigational Site|Guanajuato Gsk Investigational Site|Jalisco Gsk Investigational Site|Nuevo LeÃ³n Gsk Investigational Site|Veracruz Gsk Investigational Site|YucatÃ¡n Gsk Investigational Site|, Kent Gsk Investigational Site","GSKClinicalSupportHD@gsk.com","EU GSK Clinical Trials Call Center","+44 (0) 20 89904466","GSK Clinical Trials","2019-12-06","2020-05-25T16:38:29.195","2020-05-26T17:10:42.972","NCT03409107"]
["5ecbf48511702c1b1b916b3d","NCT03409107","2020-02-05","GlaxoSmithKline","GSK","Active, not recruiting","Anemia Studies in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat in Non-Dialysis Subjects Evaluating Hemoglobin (Hgb) and Quality of Life (ASCEND-NHQ)","Daprodustat","HIF Inhibitor","Yes","['Daprodustat']","Yes","['HIF Inhibitor']","Phase 3",2,600,"Anticipated","2018-03-05","2020-11-05",{"$nulls":5},"The purpose of this multi-center study in non-dialysis participants with anemia associated with CKD is to evaluate safety, efficacy and quality of life of daprodustat compared to placebo.",null,"A 28-week, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center, Study in Recombinant Human Erythropoietin (rhEPO) naÃ¯ve Non-dialysis Participants With Anemia Associated With Chronic Kidney Disease to Evaluate the Efficacy, Safety and Effects on Quality of Life of Daprodustat Compared to Placebo",205270,"Anaemia","Anemia|Hemoglobin C Disease|Hemoglobin SC Disease","Hematologic Diseases","Heme & Lymph Diseases","Experimental|Placebo Comparator","Daprodustat receivers|Placebo receivers","Participants will receive oral daprodustat once daily|Participants will receive oral placebo once daily","Drug","Daprodustat (GSK1278863)|Iron therapy|Placebo","Daprodustat will be available as 9 millimeter (mm) or 7 mm film-coated tablets. Daprodustat will be administered once daily via oral route and can be taken without regard to food.|Iron therapy will be administered if ferritin is <50 Nano gram per milliliter and/or TSAT is <15 percent.|Daprodustat matching placebo will be available as 9 mm or 7 mm film coated tablets. Placebo will be administered once daily via oral route and can be taken without regard to food.",null,"Daprodustat receivers|Placebo receivers","\n\n * >=18 years of age at the time of signing the informed consent.\n * Have CKD, confirmed at screening: Kidney Disease Outcomes Quality Initiative (KDOQI) CKD stages 3, 4, or 5 defined by Estimated glomerular filtration rate (eGFR) using the CKD Epidemiology Collaboration (CKD-EPI) formula.\n * Participants with Stable HemoCue Hgb from 8.5 to 10.5 at screening visit (Week -4) and from 8.5 to 10.0 g/dL at randomization (Day 1).\n * Participants may receive up to one intravenous (IV) iron dose within the 8 weeks prior to screening and NO IV iron use between screening visit and randomization (Day 1).\n * If needed, participant may be on stable maintenance oral iron supplementation. There should be <50% change in overall dose and no change in type of iron prescribed in the 4 weeks prior to Day 1 randomization visit.\n * Male and female participants are eligible. A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: Not a woman of childbearing potential (WOCBP) or WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 4 weeks after the last dose of study treatment.\n * Capable of giving signed informed consent.\n\n","\n\n * Participants who are on dialysis or clinical evidence of impending need to initiate dialysis within 180 days after randomization (Day 1).\n * Planned living-related or living-unrelated kidney transplant within 28 weeks after randomization (Day 1).\n * Transferrin saturation (TSAT) <15 percent (Screening only).\n * Ferritin <50 nanograms per milliliter (ng/mL) (Screening only).\n * History of rhEPO or rhEPO analogue use within the 8 weeks prior to screening and rhEPO use between screening and randomization (Day 1).\n * History of transfusion within the 8 weeks prior to screening and transfusion between screening and randomization (Day 1).\n * History of bone marrow aplasia or pure red cell aplasia (PRCA).\n * Participants with Megaloblastic anemia (untreated pernicious anemia and folate deficiency), thalassemia major, sickle cell disease or myelodysplastic syndrome.\n * Evidence of actively bleeding gastric, duodenal, or esophageal ulcer disease or clinically significant gastrointestinal (GI) bleeding <= 8 weeks prior to screening through to randomization (Day 1).\n * History of severe allergic or anaphylactic reactions or hypersensitivity to excipients in the investigational product.\n * Use of strong inhibitor of CYP2C8 (for example, gemfibrozil) or strong inducers of CYP2C8 (for example, rifampin/rifampicin).\n * Ferric citrate use within 4 weeks prior to randomization (Day 1).\n * Use of other investigational agent or device prior to screening through to randomization (Day 1).\n * Any prior treatment with daprodustat for a treatment duration of >30 days.\n * MI or acute coronary syndrome within the 8 weeks prior to screening through to randomization. (Day 1).\n * Stroke or transient ischemic attack within the 8 weeks prior to screening through to randomization. (Day 1).\n * Chronic Class IV heart failure, as defined by the New York Heart Association (NYHA) functional classification system.\n * QT interval corrected by Bazett's formula (QTcB) >500 milliseconds (msec) or QTcB >530 msec in participants with bundle branch block. There is no corrected QT interval (QTc) exclusion for participants with a predominantly paced rhythm.\n * Alanine transaminase (ALT) >2x upper limit of normal (ULN) at screening (Week -4).\n * Bilirubin >1.5xULN at screening (Week -4).\n * Current unstable liver or biliary disease per investigator assessment, generally defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis.\n * History of malignancy within the 2 years prior to screening through to randomization (Day 1), or currently receiving treatment for cancer, or complex kidney cyst (for example, Bosniak Category II F, III or IV) > 3 centimeters (cm).\n * Any other condition, clinical or laboratory abnormality, or examination finding that the investigator considers would put the participant at unacceptable risk, which may affect study compliance or prevent understanding of the aims or investigational procedures or possible consequences of the study.\n * Current uncontrolled hypertension as determined by the investigator.","EGFR","epidermal growth factor receptor","Protein","Ovary, Breast, Lung","Actual","2018-01-24","Actual","Anticipated","2020-11-05","Anticipated","2020-01-01","2018-01-08","2018-01-17","2020-01-31","No","Non-Dialysis\nAnemia\nChronic kidney disease\nRecombinant human erythropoietin naÃ¯ve\nHemoglobin\nDaprodustat","Interventional","Treatment","Parallel Assignment","Double (Participant, Investigator)","Randomized","18 Years",null,"All",null,"No","Yes\nIPD for this study will be made available via the Clinical Study Data Request site.",{"$nulls":3},"Yes","No",{"$nulls":17},"2017-002270-39","EudraCT Number","Mean change from Baseline in Hgb up to evaluation period (EP)","The EP is from Week 24 to Week 28.","Baseline and up to Week 28","Percentage of participants with Hgb increase of >=1.0 grams per deciliter (g/dL) from Baseline|Mean change from Baseline in short form-36 (SF-36) questionnaire vitality domain score|Percentage of Hgb responders|Percentage time Hgb in range|Mean change from Baseline for additional Hgb parameters|Time to rescue|Mean change from Baseline in CKD - Anemia Questionnaire (CKD-AQ) score|Change from Baseline in Patient Global Impression of Severity (PGI-S) score|Mean change from Baseline in SF-36 questionnaire vitality domain score|Mean change from Baseline in SF-36 questionnaire physical function domain score|Percentage of participants currently employed on the work productivity and activity impairment, anemia symptoms, clinical practice version (WPAI-ANS-CPV) scale|Change from Baseline in percent mean hours work time missed on the WPAI-ANS|CPV change from Baseline in percent impaired on the WPAI-ANS-CPV questionnaire|Change from Baseline in overall percent work impairment on the WPAI-ANS-CPV questionnaire|Change from Baseline in percent activity impairment on the WPAI-ANS-CPV questionnaire|Change from Baseline in EuroQol 5 Dimension 5 Level Health Utility Index (EQ-5D-5L) score|Change from Baseline EuroQol Visual Analogue Scale (EQ-VAS) score|Change from Baseline in systolic blood pressure (SBP), diastolic blood pressure (DBP) and mean arterial pressure (MAP) at Week 28|Percentage of participants with at least one BP exacerbation|Other Pre-specified Outcome Measures:|Incidences and severity of adverse events (AEs) and serious AEs (SAEs)","Percentage (%) of participants having a Hgb increase of >=1.0 g/dL from Baseline to EP.|Mean Change in SF-36 Vitality domain score between Baseline and Week 28.|Responders will be defined as percentage of participants whose mean Hgb is within target range.|Percentage time of Hgb within the target range will be analyzed.|Mean change in Hgb from Baseline to Week 28.|Time to rescue is defined as time to permanently stopping randomized treatment due to meeting rescue criteria.|Mean change from Baseline to week 28 by domain and overall symptom score on the CKD-AQ symptom questionnaire.|Change from Baseline to Week 28 in the severity and change in symptoms by PGI-S score.|Mean Change in individual items of the SF-36 vitality domain score between Baseline and Week 28 will be analyzed.|Mean Change in SF-36 physical function domain score between Baseline and Week 28 will be analyzed.|Percentage of participants currently employed on WPAI-ANS-CPV; questionnaire will be analyzed.|Change from Baseline in percent mean hours work time missed using WPAI-ANS-CPV questionnaire will be analyzed.|CPV change from Baseline in percent impaired on the WPAI-ANS-CPV questionnaire will be analyzed.|Change from Baseline in overall percent work impairment using the WPAI-ANS-CPV questionnaire will be analyzed.|Change from Baseline in percent activity impairment using WPAI-ANS-CPV will be analyzed.|Change from Baseline to Week 28 in health status by EQ-5D-5L score.|Change from Baseline to Week 28 in EQ-VAS score.|Change from Baseline in SBP, DBP and MAP at Week 28 will be analyzed.|Percentage of participants with at least one BP exacerbation during the study will be analyzed.|Other Pre-specified Outcome Measures:|Includes AEs of special interest and adjudicated Major adverse cardiovascular event (MACE) (composite of all-cause mortality, non-fatal Myocardial infarction","Baseline and up to Week 28|Baseline and Week 28|Up to Week 28|Baseline and at Week 28|MI and non-fatal stroke).",{"$nulls":3},"Ciudad Autonoma De Buenos Aires, Buenos Aires, Argentina, C1128Aaf Gsk Investigational SiteCiudad Autonoma De Buenos Aires, Buenos Aires, Argentina, C1425Agc Gsk Investigational SiteMar Del Plata, Buenos Aires, Argentina, 7600 Gsk Investigational SiteMar Del Plata, Buenos Aires, Argentina, B7600Fzn Gsk Investigational SiteSan Nicolas, Buenos Aires, Argentina, B2900Dmh|Cordoba, CÃ³rdova, Argentina, 5003|Santa Fe, Argentina, 3000|Rosario, Santa Fe, Argentina, S2000Dej|Fitzroy, Australia, 3065|Murdoch, Western|Sydney, New South Wales, Australia, 2010|Heidelberg, Victoria, Australia, 3084 Gsk Investigational SiteParkville, Victoria, Australia, 3050|Feira De Santana., Bahia, Brazil, 44001-584 Gsk Investigational SiteSalvador, Bahia, Brazil, 40415-065|Vitoria, EspÃ­rito Santo, Brazil, 29055450|SÃ£o Paulo, Brazil, 04038002|RibeirÃ£o Preto, SÃ£o Paulo, Brazil, 14025170 Gsk Investigational SiteSanto AndrÃ© - Sp, SÃ£o Paulo, Brazil, 09080-110 Gsk Investigational SiteSao Jose Do Rio Preto, SÃ£o Paulo, Brazil, 15015200 Gsk Investigational SiteSao Jose Do Rio Preto, SÃ£o Paulo, Brazil, 15090-000 Gsk Investigational SiteSÃ£o Bernardo Do Campo, SÃ£o Paulo, Brazil, 09715090|Victoria, British Columbia, Canada, V8V 4A1|Quebec, Canada, G3K 2P8|Brampton, Ontario, Canada, L6T 0G1 Gsk Investigational SiteGuelph, Ontario, Canada, N1H 1B1 Gsk Investigational SiteKitchener, Ontario, Canada, N2H 5Z8 Gsk Investigational SiteOttawa, Ontario, Canada, K1H 1A2 Gsk Investigational SiteSarnia, Ontario, Canada, N7T 4X3 Gsk Investigational SiteSudbury, Ontario, Canada Gsk Investigational SiteToronto, Ontario, Canada, M5B 1W8 Gsk Investigational SiteToronto, Ontario, Canada, M9N 1N8 Gsk Investigational SiteToronto, Ontario, Canada, M9V 4B4|MontrÃ©al, Quebec, Canada, H1M 1B1 Gsk Investigational SiteQuebec City, Quebec, Canada, G2J 0C4 Gsk Investigational SiteSt-Charles-BorromÃ©e, Quebec, Canada, J6E 2B4|Grenoble Cedex 9, France, 38043 Gsk Investigational SiteLe Mans Cedex 9, France, 72037 Gsk Investigational SiteMarseille Cedex 5, France, 13385 Gsk Investigational SiteMelun, France, 77000 Gsk Investigational SiteMulhouse Cedex, France, 68070 Gsk Investigational SiteNantes Cedex 1, France, 44093 Gsk Investigational SiteNice Cedex 1, France, 06001 Gsk Investigational SiteSaint-Priest En Jarez, France, 42270|Catanzaro, Calabria, Italy, 88100|Napoli, Campania, Italy, 80131|Bologna, Emilia-Romagna, Italy, 40138 Gsk Investigational SiteModena, Emilia-Romagna, Italy, 41124|Genova, Liguria, Italy, 16132|Pavia, Lombardia, Italy, 27100|Mestre, Veneto, Italy, 30174 Korea, Republic Of Gsk Investigational SiteBusan, Korea, Republic Of, 49201 Gsk Investigational SiteBusan, Korea, Republic Of, 49241 Gsk Investigational SiteDaegu-Si, Korea, Republic Of, 42601 Gsk Investigational SiteDaegu, Korea, Republic Of, 42415 Gsk Investigational SiteGyeonggi-Do, Korea, Republic Of, 463-712 Gsk Investigational SiteSeongnam-Si, Gyeonggi-Do, Korea, Republic Of, 13620 Gsk Investigational SiteSeoul, Korea, Republic Of, 03312 Gsk Investigational SiteSeoul, Korea, Republic Of, 08308|Guadalajara, Mexico, 44600 Gsk Investigational SiteMerida, Mexico, 97000 Gsk Investigational SiteVeracruz, Mexico, 91900|Leon, Guanajuato, Mexico, 37390|Guadalajara, Jalisco, Mexico, 44150|Monterrey, Nuevo LeÃ³n, Mexico, 64060|Boca Del Rio, Veracruz, Mexico, 24290 Gsk Investigational SiteCÃ³rdoba, Veracruz, Mexico, 94550|Merida, YucatÃ¡n, Mexico, 97070|Bialystok, Poland, 15-276 Gsk Investigational SiteCiechanow, Poland, 06-400 Gsk Investigational SiteKrakow, Poland, 30510 Gsk Investigational SiteKrakow, Poland, 31-513 Gsk Investigational SiteKrakow, Poland, 31-559 Gsk Investigational SiteLodz, Poland, 92-213 Gsk Investigational SiteLublin, Poland, 20-068 Gsk Investigational SiteOlawa, Poland, 55-200 Gsk Investigational SitePleszew, Poland, 63-300 Gsk Investigational SiteSosnowiec, Poland, 41-200 Gsk Investigational SiteSwidnik, Poland, 21-040 Gsk Investigational SiteSzczecin, Poland, 70-111 Gsk Investigational SiteTczew, Poland, 83-110 Gsk Investigational SiteWarszawa, Poland, 01-868 Gsk Investigational SiteWarszawa, Poland, 02-801 Gsk Investigational SiteWarszawa, Poland, 04-749|Brasov, Romania, 500283 Gsk Investigational SiteBucharest, Romania, 022328 Gsk Investigational SiteBucharest, Romania, 022328 Gsk Investigational SiteBucharest, Romania, 042122 Gsk Investigational SiteCluj-Napoca, Romania, 400139 Gsk Investigational SiteCraiova, Romania, 200642 Gsk Investigational SiteDeva, Romania, 330084 Gsk Investigational SiteOradea, Romania, 410469 Gsk Investigational SiteTargu Mures, Romania, 540096 Gsk Investigational SiteTimisoara, Romania, 300723 Russian Federation Gsk Investigational SiteIzhevsk, Russian Federation, 426061 Gsk Investigational SiteKaliningrad, Russian Federation, 236016 Gsk Investigational SiteKemerovo, Russian Federation, 650066 Gsk Investigational SiteKrasnoyarsk, Russian Federation, 660022 Gsk Investigational SiteMoscow, Russian Federation, 121359 Gsk Investigational SiteNizhniy Novgorod, Russian Federation, 603126 Gsk Investigational SitePyatigorsk, Russian Federation, 357500 Gsk Investigational SitePyatigorsk, Russian Federation, 357538 Gsk Investigational SiteRostov-On-Don, Russian Federation, 344022 Gsk Investigational SiteRyazan, Russian Federation, 390037 Gsk Investigational SiteSaint Petersburg, Russian Federation, 194355 Gsk Investigational SiteSaint Petersburg, Russian Federation, 197022 Gsk Investigational SiteStavropol, Russian Federation, 355017 Gsk Investigational SiteYaroslavl, Russian Federation, 150000 Gsk Investigational SiteYaroslavl, Russian Federation, 150030 Gsk Investigational SiteYaroslavl, Russian Federation, 150062|Badalona, Spain, 08916 Gsk Investigational SiteMadrid, Spain, 28040 Gsk Investigational SiteSantiago De Compostela, Spain|Canterbury, Kent, United Kingdom, Ct1 3Ng|Derby, United Kingdom, De22 3Ne Gsk Investigational SiteLondon, United Kingdom, Se5 9Rs Gsk Investigational SitePeterborough, United Kingdom, Pe3 9Gz Gsk Investigational SitePlymouth, United Kingdom, Pl6 8Dh Gsk Investigational SiteShrewsbury, United Kingdom, Sy3 8Xq Gsk Investigational SiteSwansea, United Kingdom, Sa6 6Nl|Homewood, Alabama, United States, 35209|Little Rock, Arkansas, United States, 72204|Downey, California, United States, 90242 Gsk Investigational SiteFresno, California, United States, 93720 Gsk Investigational SiteLynwood, California, United States, 90262 Gsk Investigational SiteNorthridge, California, United States, 91324 Gsk Investigational SiteNorthridge, California, United States, 91325 Gsk Investigational SiteRiverside, California, United States, 82503 Gsk Investigational SiteSalinas, California, United States, 93901 Gsk Investigational SiteSanta Ana, California, United States, 92704|Denver, Colorado, United States, 80230|Hartford, Connecticut, United States, 06112 Gsk Investigational SiteMiddlebury, Connecticut, United States, 06762|Coral Springs, Florida, United States, 33067 Gsk Investigational SiteHollywood, Florida, United States, 33021-5424 Gsk Investigational SiteHollywood, Florida, United States, 33024 Gsk Investigational SiteKissimmee, Florida, United States, 34741 Gsk Investigational SiteLauderdale Lakes, Florida, United States, 33313 Gsk Investigational SiteTampa, Florida, United States, 33614|Adairsville, Georgia, United States, 30103 Gsk Investigational SiteMacon, Georgia, United States, 31201 Gsk Investigational SiteMacon, Georgia, United States, 31217 Gsk Investigational SiteStatesboro, Georgia, United States, 30458|Indianapolis, Indiana, United States, 46260|Overland Park, Kansas, United States, 66210|Buckley, Michigan, United States, 49620 Gsk Investigational SiteDetroit, Michigan, United States, 48202 Gsk Investigational SiteSaint Clair Shores, Michigan, United States, 48081|Brookhaven, Mississippi, United States, 39601|Saint Louis, Missouri, United States, 63136|Portsmouth, New Hampshire, United States, 03801|Asheville, North Carolina, United States, 28801 Gsk Investigational SiteCharlotte, North Carolina, United States, 28262 Gsk Investigational SiteDurham, North Carolina, United States, 27704|Midwest City, Oklahoma, United States, 73130 Gsk Investigational SiteOklahoma City, Oklahoma, United States, 73112|Beaver, Pennsylvania, United States, 15009 Gsk Investigational SiteDuncansville, Pennsylvania, United States, 16635 Gsk Investigational SiteJersey Shore, Pennsylvania, United States, 17740 Gsk Investigational SiteScottdale, Pennsylvania, United States, 15683 Gsk Investigational SiteSmithfield, Pennsylvania, United States, 15478 Gsk Investigational SiteWest Reading, Pennsylvania, United States, 19611|Orangeburg, South Carolina, United States, 29118|Kingsport, Tennessee, United States, 37660 Gsk Investigational SiteMemphis, Tennessee, United States, 38163|Desoto, Texas, United States, 75115 Gsk Investigational SiteEl Paso, Texas, United States, 79935 Gsk Investigational SiteMcallen, Texas, United States, 78503 Gsk Investigational SiteWaxahachie, Texas, United States, 75165|Norfolk, Virginia, United States, 23502","Alabama|Arkansas|California|Colorado|Connecticut|Florida|Georgia|Indiana|Kansas|Michigan|Mississippi|Missouri|New Hampshire|North Carolina|Oklahoma|Pennsylvania|South Carolina|Tennessee|Texas|Virginia","Argentina|Australia|Brazil|Canada|France|Italy|Mexico|Poland|Romania|Spain|United Kingdom|United States","Buenos Aires Gsk Investigational Site|CÃ³rdova Gsk Investigational Site|Gsk Investigational Site|Santa Fe Gsk Investigational Site|New South Wales Gsk Investigational Site|Victoria Gsk Investigational Site|Bahia Gsk Investigational Site|EspÃ­rito Santo Gsk Investigational Site|SÃ£o Paulo Gsk Investigational Site|British Columbia Gsk Investigational Site|Ontario Gsk Investigational Site|Quebec Gsk Investigational Site|Calabria Gsk Investigational Site|Campania Gsk Investigational Site|Emilia-Romagna Gsk Investigational Site|Liguria Gsk Investigational Site|Lombardia Gsk Investigational Site|Veneto Gsk Investigational Site|Guanajuato Gsk Investigational Site|Jalisco Gsk Investigational Site|Nuevo LeÃ³n Gsk Investigational Site|Veracruz Gsk Investigational Site|YucatÃ¡n Gsk Investigational Site|, Kent Gsk Investigational Site",{"$nulls":3},"GSK Clinical Trials","2020-01-31","2020-05-25T16:38:29.629","2020-05-26T17:10:42.972","NCT03409107"]
["5ecbf48611702c1b1b916b3e","NCT03409107","2020-03-03","GlaxoSmithKline","GSK","Active, not recruiting","Anemia Studies in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat in Non-Dialysis Subjects Evaluating Hemoglobin (Hgb) and Quality of Life (ASCEND-NHQ)","Daprodustat","HIF Inhibitor","Yes","['Daprodustat']","Yes","['HIF Inhibitor']","Phase 3",2,600,"Anticipated","2018-03-05","2020-10-06",{"$nulls":5},"The purpose of this multi-center study in non-dialysis participants with anemia associated with CKD is to evaluate safety, efficacy and quality of life of daprodustat compared to placebo.",null,"A 28-week, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center, Study in Recombinant Human Erythropoietin (rhEPO) naÃ¯ve Non-dialysis Participants With Anemia Associated With Chronic Kidney Disease to Evaluate the Efficacy, Safety and Effects on Quality of Life of Daprodustat Compared to Placebo",205270,"Anaemia","Anemia|Hemoglobin C Disease|Hemoglobin SC Disease","Hematologic Diseases","Heme & Lymph Diseases","Experimental|Placebo Comparator","Daprodustat receivers|Placebo receivers","Participants will receive oral daprodustat once daily|Participants will receive oral placebo once daily","Drug","Daprodustat (GSK1278863)|Iron therapy|Placebo","Daprodustat will be available as 9 millimeter (mm) or 7 mm film-coated tablets. Daprodustat will be administered once daily via oral route and can be taken without regard to food.|Iron therapy will be administered if ferritin is <50 Nano gram per milliliter and/or TSAT is <15 percent.|Daprodustat matching placebo will be available as 9 mm or 7 mm film coated tablets. Placebo will be administered once daily via oral route and can be taken without regard to food.",null,"Daprodustat receivers|Placebo receivers","\n\n * >=18 years of age at the time of signing the informed consent.\n * Have CKD, confirmed at screening: Kidney Disease Outcomes Quality Initiative (KDOQI) CKD stages 3, 4, or 5 defined by Estimated glomerular filtration rate (eGFR) using the CKD Epidemiology Collaboration (CKD-EPI) formula.\n * Participants with Stable HemoCue Hgb from 8.5 to 10.5 at screening visit (Week -4) and from 8.5 to 10.0 g/dL at randomization (Day 1).\n * Participants may receive up to one intravenous (IV) iron dose within the 8 weeks prior to screening and NO IV iron use between screening visit and randomization (Day 1).\n * If needed, participant may be on stable maintenance oral iron supplementation. There should be <50% change in overall dose and no change in type of iron prescribed in the 4 weeks prior to Day 1 randomization visit.\n * Male and female participants are eligible. A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: Not a woman of childbearing potential (WOCBP) or WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 4 weeks after the last dose of study treatment.\n * Capable of giving signed informed consent.\n\n","\n\n * Participants who are on dialysis or clinical evidence of impending need to initiate dialysis within 180 days after randomization (Day 1).\n * Planned living-related or living-unrelated kidney transplant within 28 weeks after randomization (Day 1).\n * Transferrin saturation (TSAT) <15 percent (Screening only).\n * Ferritin <50 nanograms per milliliter (ng/mL) (Screening only).\n * History of rhEPO or rhEPO analogue use within the 8 weeks prior to screening and rhEPO use between screening and randomization (Day 1).\n * History of transfusion within the 8 weeks prior to screening and transfusion between screening and randomization (Day 1).\n * History of bone marrow aplasia or pure red cell aplasia (PRCA).\n * Participants with Megaloblastic anemia (untreated pernicious anemia and folate deficiency), thalassemia major, sickle cell disease or myelodysplastic syndrome.\n * Evidence of actively bleeding gastric, duodenal, or esophageal ulcer disease or clinically significant gastrointestinal (GI) bleeding <= 8 weeks prior to screening through to randomization (Day 1).\n * History of severe allergic or anaphylactic reactions or hypersensitivity to excipients in the investigational product.\n * Use of strong inhibitor of CYP2C8 (for example, gemfibrozil) or strong inducers of CYP2C8 (for example, rifampin/rifampicin).\n * Ferric citrate use within 4 weeks prior to randomization (Day 1).\n * Use of other investigational agent or device prior to screening through to randomization (Day 1).\n * Any prior treatment with daprodustat for a treatment duration of >30 days.\n * MI or acute coronary syndrome within the 8 weeks prior to screening through to randomization. (Day 1).\n * Stroke or transient ischemic attack within the 8 weeks prior to screening through to randomization. (Day 1).\n * Chronic Class IV heart failure, as defined by the New York Heart Association (NYHA) functional classification system.\n * QT interval corrected by Bazett's formula (QTcB) >500 milliseconds (msec) or QTcB >530 msec in participants with bundle branch block. There is no corrected QT interval (QTc) exclusion for participants with a predominantly paced rhythm.\n * Alanine transaminase (ALT) >2x upper limit of normal (ULN) at screening (Week -4).\n * Bilirubin >1.5xULN at screening (Week -4).\n * Current unstable liver or biliary disease per investigator assessment, generally defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis.\n * History of malignancy within the 2 years prior to screening through to randomization (Day 1), or currently receiving treatment for cancer, or complex kidney cyst (for example, Bosniak Category II F, III or IV) > 3 centimeters (cm).\n * Any other condition, clinical or laboratory abnormality, or examination finding that the investigator considers would put the participant at unacceptable risk, which may affect study compliance or prevent understanding of the aims or investigational procedures or possible consequences of the study.\n * Current uncontrolled hypertension as determined by the investigator.","EGFR","epidermal growth factor receptor","Protein","Ovary, Breast, Lung","Actual","2018-01-24","Actual","Anticipated","2020-10-06","Anticipated","2020-03-01","2018-01-08","2018-01-17","2020-03-02","No","Non-Dialysis\nAnemia\nChronic kidney disease\nRecombinant human erythropoietin naÃ¯ve\nHemoglobin\nDaprodustat","Interventional","Treatment","Parallel Assignment","Double (Participant, Investigator)","Randomized","18 Years",null,"All",null,"No","Yes\nIPD for this study will be made available via the Clinical Study Data Request site.",{"$nulls":3},"Yes","No",{"$nulls":17},"2017-002270-39","EudraCT Number","Mean change from Baseline in Hgb up to evaluation period (EP)","The EP is from Week 24 to Week 28.","Baseline and up to Week 28","Percentage of participants with Hgb increase of >=1.0 grams per deciliter (g/dL) from Baseline|Mean change from Baseline in short form-36 (SF-36) questionnaire vitality domain score|Percentage of Hgb responders|Percentage time Hgb in range|Mean change from Baseline for additional Hgb parameters|Time to rescue|Mean change from Baseline in CKD - Anemia Questionnaire (CKD-AQ) score|Change from Baseline in Patient Global Impression of Severity (PGI-S) score|Mean change from Baseline in SF-36 questionnaire vitality domain score|Mean change from Baseline in SF-36 questionnaire physical function domain score|Percentage of participants currently employed on the work productivity and activity impairment, anemia symptoms, clinical practice version (WPAI-ANS-CPV) scale|Change from Baseline in percent mean hours work time missed on the WPAI-ANS|CPV change from Baseline in percent impaired on the WPAI-ANS-CPV questionnaire|Change from Baseline in overall percent work impairment on the WPAI-ANS-CPV questionnaire|Change from Baseline in percent activity impairment on the WPAI-ANS-CPV questionnaire|Change from Baseline in EuroQol 5 Dimension 5 Level Health Utility Index (EQ-5D-5L) score|Change from Baseline EuroQol Visual Analogue Scale (EQ-VAS) score|Change from Baseline in systolic blood pressure (SBP), diastolic blood pressure (DBP) and mean arterial pressure (MAP) at Week 28|Percentage of participants with at least one BP exacerbation|Other Pre-specified Outcome Measures:|Incidences and severity of adverse events (AEs) and serious AEs (SAEs)","Percentage (%) of participants having a Hgb increase of >=1.0 g/dL from Baseline to EP.|Mean Change in SF-36 Vitality domain score between Baseline and Week 28.|Responders will be defined as percentage of participants whose mean Hgb is within target range.|Percentage time of Hgb within the target range will be analyzed.|Mean change in Hgb from Baseline to Week 28.|Time to rescue is defined as time to permanently stopping randomized treatment due to meeting rescue criteria.|Mean change from Baseline to week 28 by domain and overall symptom score on the CKD-AQ symptom questionnaire.|Change from Baseline to Week 28 in the severity and change in symptoms by PGI-S score.|Mean Change in individual items of the SF-36 vitality domain score between Baseline and Week 28 will be analyzed.|Mean Change in SF-36 physical function domain score between Baseline and Week 28 will be analyzed.|Percentage of participants currently employed on WPAI-ANS-CPV; questionnaire will be analyzed.|Change from Baseline in percent mean hours work time missed using WPAI-ANS-CPV questionnaire will be analyzed.|CPV change from Baseline in percent impaired on the WPAI-ANS-CPV questionnaire will be analyzed.|Change from Baseline in overall percent work impairment using the WPAI-ANS-CPV questionnaire will be analyzed.|Change from Baseline in percent activity impairment using WPAI-ANS-CPV will be analyzed.|Change from Baseline to Week 28 in health status by EQ-5D-5L score.|Change from Baseline to Week 28 in EQ-VAS score.|Change from Baseline in SBP, DBP and MAP at Week 28 will be analyzed.|Percentage of participants with at least one BP exacerbation during the study will be analyzed.|Other Pre-specified Outcome Measures:|Includes AEs of special interest and adjudicated Major adverse cardiovascular event (MACE) (composite of all-cause mortality, non-fatal Myocardial infarction","Baseline and up to Week 28|Baseline and Week 28|Up to Week 28|Baseline and at Week 28|MI and non-fatal stroke).",{"$nulls":3},"Ciudad Autonoma De Buenos Aires, Buenos Aires, Argentina, C1128Aaf Gsk Investigational SiteCiudad Autonoma De Buenos Aires, Buenos Aires, Argentina, C1425Agc Gsk Investigational SiteMar Del Plata, Buenos Aires, Argentina, 7600 Gsk Investigational SiteMar Del Plata, Buenos Aires, Argentina, B7600Fzn Gsk Investigational SiteSan Nicolas, Buenos Aires, Argentina, B2900Dmh|Cordoba, CÃ³rdova, Argentina, 5003|Santa Fe, Argentina, 3000|Rosario, Santa Fe, Argentina, S2000Dej|Fitzroy, Australia, 3065|Murdoch, Western|Sydney, New South Wales, Australia, 2010|Heidelberg, Victoria, Australia, 3084 Gsk Investigational SiteParkville, Victoria, Australia, 3050|Feira De Santana., Bahia, Brazil, 44001-584 Gsk Investigational SiteSalvador, Bahia, Brazil, 40415-065|Vitoria, EspÃ­rito Santo, Brazil, 29055450|SÃ£o Paulo, Brazil, 04038002|RibeirÃ£o Preto, SÃ£o Paulo, Brazil, 14025170 Gsk Investigational SiteSanto AndrÃ© - Sp, SÃ£o Paulo, Brazil, 09080-110 Gsk Investigational SiteSao Jose Do Rio Preto, SÃ£o Paulo, Brazil, 15015200 Gsk Investigational SiteSao Jose Do Rio Preto, SÃ£o Paulo, Brazil, 15090-000 Gsk Investigational SiteSÃ£o Bernardo Do Campo, SÃ£o Paulo, Brazil, 09715090|Victoria, British Columbia, Canada, V8V 4A1|Quebec, Canada, G3K 2P8|Brampton, Ontario, Canada, L6T 0G1 Gsk Investigational SiteGuelph, Ontario, Canada, N1H 1B1 Gsk Investigational SiteKitchener, Ontario, Canada, N2H 5Z8 Gsk Investigational SiteOttawa, Ontario, Canada, K1H 1A2 Gsk Investigational SiteSarnia, Ontario, Canada, N7T 4X3 Gsk Investigational SiteSudbury, Ontario, Canada Gsk Investigational SiteToronto, Ontario, Canada, M5B 1W8 Gsk Investigational SiteToronto, Ontario, Canada, M9N 1N8 Gsk Investigational SiteToronto, Ontario, Canada, M9V 4B4|MontrÃ©al, Quebec, Canada, H1M 1B1 Gsk Investigational SiteQuebec City, Quebec, Canada, G2J 0C4 Gsk Investigational SiteSt-Charles-BorromÃ©e, Quebec, Canada, J6E 2B4|Grenoble Cedex 9, France, 38043 Gsk Investigational SiteLe Mans Cedex 9, France, 72037 Gsk Investigational SiteMarseille Cedex 5, France, 13385 Gsk Investigational SiteMelun, France, 77000 Gsk Investigational SiteMulhouse Cedex, France, 68070 Gsk Investigational SiteNantes Cedex 1, France, 44093 Gsk Investigational SiteNice Cedex 1, France, 06001 Gsk Investigational SiteSaint-Priest En Jarez, France, 42270|Catanzaro, Calabria, Italy, 88100|Napoli, Campania, Italy, 80131|Bologna, Emilia-Romagna, Italy, 40138 Gsk Investigational SiteModena, Emilia-Romagna, Italy, 41124|Genova, Liguria, Italy, 16132|Pavia, Lombardia, Italy, 27100|Mestre, Veneto, Italy, 30174 Korea, Republic Of Gsk Investigational SiteBusan, Korea, Republic Of, 49201 Gsk Investigational SiteBusan, Korea, Republic Of, 49241 Gsk Investigational SiteDaegu-Si, Korea, Republic Of, 42601 Gsk Investigational SiteDaegu, Korea, Republic Of, 42415 Gsk Investigational SiteGyeonggi-Do, Korea, Republic Of, 463-712 Gsk Investigational SiteSeongnam-Si, Gyeonggi-Do, Korea, Republic Of, 13620 Gsk Investigational SiteSeoul, Korea, Republic Of, 03312 Gsk Investigational SiteSeoul, Korea, Republic Of, 08308|Guadalajara, Mexico, 44600 Gsk Investigational SiteMerida, Mexico, 97000 Gsk Investigational SiteVeracruz, Mexico, 91900|Leon, Guanajuato, Mexico, 37390|Guadalajara, Jalisco, Mexico, 44150|Monterrey, Nuevo LeÃ³n, Mexico, 64060|Boca Del Rio, Veracruz, Mexico, 24290 Gsk Investigational SiteCÃ³rdoba, Veracruz, Mexico, 94550|Merida, YucatÃ¡n, Mexico, 97070|Bialystok, Poland, 15-276 Gsk Investigational SiteCiechanow, Poland, 06-400 Gsk Investigational SiteKrakow, Poland, 30510 Gsk Investigational SiteKrakow, Poland, 31-513 Gsk Investigational SiteKrakow, Poland, 31-559 Gsk Investigational SiteLodz, Poland, 92-213 Gsk Investigational SiteLublin, Poland, 20-068 Gsk Investigational SiteOlawa, Poland, 55-200 Gsk Investigational SitePleszew, Poland, 63-300 Gsk Investigational SiteSosnowiec, Poland, 41-200 Gsk Investigational SiteSwidnik, Poland, 21-040 Gsk Investigational SiteSzczecin, Poland, 70-111 Gsk Investigational SiteTczew, Poland, 83-110 Gsk Investigational SiteWarszawa, Poland, 01-868 Gsk Investigational SiteWarszawa, Poland, 02-801 Gsk Investigational SiteWarszawa, Poland, 04-749|Brasov, Romania, 500283 Gsk Investigational SiteBucharest, Romania, 022328 Gsk Investigational SiteBucharest, Romania, 022328 Gsk Investigational SiteBucharest, Romania, 042122 Gsk Investigational SiteCluj-Napoca, Romania, 400139 Gsk Investigational SiteCraiova, Romania, 200642 Gsk Investigational SiteDeva, Romania, 330084 Gsk Investigational SiteOradea, Romania, 410469 Gsk Investigational SiteTargu Mures, Romania, 540096 Gsk Investigational SiteTimisoara, Romania, 300723 Russian Federation Gsk Investigational SiteIzhevsk, Russian Federation, 426061 Gsk Investigational SiteKaliningrad, Russian Federation, 236016 Gsk Investigational SiteKemerovo, Russian Federation, 650066 Gsk Investigational SiteKrasnoyarsk, Russian Federation, 660022 Gsk Investigational SiteMoscow, Russian Federation, 121359 Gsk Investigational SiteNizhniy Novgorod, Russian Federation, 603126 Gsk Investigational SitePyatigorsk, Russian Federation, 357500 Gsk Investigational SitePyatigorsk, Russian Federation, 357538 Gsk Investigational SiteRostov-On-Don, Russian Federation, 344022 Gsk Investigational SiteRyazan, Russian Federation, 390037 Gsk Investigational SiteSaint Petersburg, Russian Federation, 194355 Gsk Investigational SiteSaint Petersburg, Russian Federation, 197022 Gsk Investigational SiteStavropol, Russian Federation, 355017 Gsk Investigational SiteYaroslavl, Russian Federation, 150000 Gsk Investigational SiteYaroslavl, Russian Federation, 150030 Gsk Investigational SiteYaroslavl, Russian Federation, 150062|Badalona, Spain, 08916 Gsk Investigational SiteMadrid, Spain, 28040 Gsk Investigational SiteSantiago De Compostela, Spain|Canterbury, Kent, United Kingdom, Ct1 3Ng|Derby, United Kingdom, De22 3Ne Gsk Investigational SiteLondon, United Kingdom, Se5 9Rs Gsk Investigational SitePeterborough, United Kingdom, Pe3 9Gz Gsk Investigational SitePlymouth, United Kingdom, Pl6 8Dh Gsk Investigational SiteShrewsbury, United Kingdom, Sy3 8Xq Gsk Investigational SiteSwansea, United Kingdom, Sa6 6Nl|Homewood, Alabama, United States, 35209|Little Rock, Arkansas, United States, 72204|Downey, California, United States, 90242 Gsk Investigational SiteFresno, California, United States, 93720 Gsk Investigational SiteLynwood, California, United States, 90262 Gsk Investigational SiteNorthridge, California, United States, 91324 Gsk Investigational SiteNorthridge, California, United States, 91325 Gsk Investigational SiteRiverside, California, United States, 82503 Gsk Investigational SiteSalinas, California, United States, 93901 Gsk Investigational SiteSanta Ana, California, United States, 92704|Denver, Colorado, United States, 80230|Hartford, Connecticut, United States, 06112 Gsk Investigational SiteMiddlebury, Connecticut, United States, 06762|Coral Springs, Florida, United States, 33067 Gsk Investigational SiteHollywood, Florida, United States, 33021-5424 Gsk Investigational SiteHollywood, Florida, United States, 33024 Gsk Investigational SiteKissimmee, Florida, United States, 34741 Gsk Investigational SiteLauderdale Lakes, Florida, United States, 33313 Gsk Investigational SiteTampa, Florida, United States, 33614|Adairsville, Georgia, United States, 30103 Gsk Investigational SiteMacon, Georgia, United States, 31201 Gsk Investigational SiteMacon, Georgia, United States, 31217 Gsk Investigational SiteStatesboro, Georgia, United States, 30458|Indianapolis, Indiana, United States, 46260|Overland Park, Kansas, United States, 66210|Buckley, Michigan, United States, 49620 Gsk Investigational SiteDetroit, Michigan, United States, 48202 Gsk Investigational SiteSaint Clair Shores, Michigan, United States, 48081|Brookhaven, Mississippi, United States, 39601|Saint Louis, Missouri, United States, 63136|Portsmouth, New Hampshire, United States, 03801|Asheville, North Carolina, United States, 28801 Gsk Investigational SiteCharlotte, North Carolina, United States, 28262 Gsk Investigational SiteDurham, North Carolina, United States, 27704|Midwest City, Oklahoma, United States, 73130 Gsk Investigational SiteOklahoma City, Oklahoma, United States, 73112|Beaver, Pennsylvania, United States, 15009 Gsk Investigational SiteDuncansville, Pennsylvania, United States, 16635 Gsk Investigational SiteJersey Shore, Pennsylvania, United States, 17740 Gsk Investigational SiteScottdale, Pennsylvania, United States, 15683 Gsk Investigational SiteSmithfield, Pennsylvania, United States, 15478 Gsk Investigational SiteWest Reading, Pennsylvania, United States, 19611|Orangeburg, South Carolina, United States, 29118|Kingsport, Tennessee, United States, 37660 Gsk Investigational SiteMemphis, Tennessee, United States, 38163|Desoto, Texas, United States, 75115 Gsk Investigational SiteEl Paso, Texas, United States, 79935 Gsk Investigational SiteMcallen, Texas, United States, 78503 Gsk Investigational SiteWaxahachie, Texas, United States, 75165|Norfolk, Virginia, United States, 23502","Alabama|Arkansas|California|Colorado|Connecticut|Florida|Georgia|Indiana|Kansas|Michigan|Mississippi|Missouri|New Hampshire|North Carolina|Oklahoma|Pennsylvania|South Carolina|Tennessee|Texas|Virginia","Argentina|Australia|Brazil|Canada|France|Italy|Mexico|Poland|Romania|Spain|United Kingdom|United States","Buenos Aires Gsk Investigational Site|CÃ³rdova Gsk Investigational Site|Gsk Investigational Site|Santa Fe Gsk Investigational Site|New South Wales Gsk Investigational Site|Victoria Gsk Investigational Site|Bahia Gsk Investigational Site|EspÃ­rito Santo Gsk Investigational Site|SÃ£o Paulo Gsk Investigational Site|British Columbia Gsk Investigational Site|Ontario Gsk Investigational Site|Quebec Gsk Investigational Site|Calabria Gsk Investigational Site|Campania Gsk Investigational Site|Emilia-Romagna Gsk Investigational Site|Liguria Gsk Investigational Site|Lombardia Gsk Investigational Site|Veneto Gsk Investigational Site|Guanajuato Gsk Investigational Site|Jalisco Gsk Investigational Site|Nuevo LeÃ³n Gsk Investigational Site|Veracruz Gsk Investigational Site|YucatÃ¡n Gsk Investigational Site|, Kent Gsk Investigational Site",{"$nulls":3},"GSK Clinical Trials","2020-03-02","2020-05-25T16:38:30.140","2020-05-26T17:10:42.972","NCT03409107"]
["5ecbf486fe30261b1a048331","NCT03409107","2020-03-23","GlaxoSmithKline","GSK","Active, not recruiting","Anemia Studies in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat in Non-Dialysis Subjects Evaluating Hemoglobin (Hgb) and Quality of Life (ASCEND-NHQ)","Daprodustat","HIF Inhibitor","Yes","['Daprodustat']","Yes","['HIF Inhibitor']","Phase 3",2,600,"Anticipated","2018-03-05","2020-10-06",{"$nulls":5},"The purpose of this multi-center study in non-dialysis participants with anemia associated with CKD is to evaluate safety, efficacy and quality of life of daprodustat compared to placebo.",null,"A 28-week, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center, Study in Recombinant Human Erythropoietin (rhEPO) naÃ¯ve Non-dialysis Participants With Anemia Associated With Chronic Kidney Disease to Evaluate the Efficacy, Safety and Effects on Quality of Life of Daprodustat Compared to Placebo",205270,"Anaemia","Anemia|Hemoglobin C Disease|Hemoglobin SC Disease","Hematologic Diseases","Heme & Lymph Diseases","Experimental|Placebo Comparator","Daprodustat receivers|Placebo receivers","Participants will receive oral daprodustat once daily|Participants will receive oral placebo once daily","Drug","Daprodustat (GSK1278863)|Iron therapy|Placebo","Daprodustat will be available as 9 millimeter (mm) or 7 mm film-coated tablets. Daprodustat will be administered once daily via oral route and can be taken without regard to food.|Iron therapy will be administered if ferritin is <50 Nano gram per milliliter and/or TSAT is <15 percent.|Daprodustat matching placebo will be available as 9 mm or 7 mm film coated tablets. Placebo will be administered once daily via oral route and can be taken without regard to food.",null,"Daprodustat receivers|Placebo receivers","\n\n * >=18 years of age at the time of signing the informed consent.\n * Have CKD, confirmed at screening: Kidney Disease Outcomes Quality Initiative (KDOQI) CKD stages 3, 4, or 5 defined by Estimated glomerular filtration rate (eGFR) using the CKD Epidemiology Collaboration (CKD-EPI) formula.\n * Participants with Stable HemoCue Hgb from 8.5 to 10.5 at screening visit (Week -4) and from 8.5 to 10.0 g/dL at randomization (Day 1).\n * Participants may receive up to one intravenous (IV) iron dose within the 8 weeks prior to screening and NO IV iron use between screening visit and randomization (Day 1).\n * If needed, participant may be on stable maintenance oral iron supplementation. There should be <50% change in overall dose and no change in type of iron prescribed in the 4 weeks prior to Day 1 randomization visit.\n * Male and female participants are eligible. A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: Not a woman of childbearing potential (WOCBP) or WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 4 weeks after the last dose of study treatment.\n * Capable of giving signed informed consent.\n\n","\n\n * Participants who are on dialysis or clinical evidence of impending need to initiate dialysis within 180 days after randomization (Day 1).\n * Planned living-related or living-unrelated kidney transplant within 28 weeks after randomization (Day 1).\n * Transferrin saturation (TSAT) <15 percent (Screening only).\n * Ferritin <50 nanograms per milliliter (ng/mL) (Screening only).\n * History of rhEPO or rhEPO analogue use within the 8 weeks prior to screening and rhEPO use between screening and randomization (Day 1).\n * History of transfusion within the 8 weeks prior to screening and transfusion between screening and randomization (Day 1).\n * History of bone marrow aplasia or pure red cell aplasia (PRCA).\n * Participants with Megaloblastic anemia (untreated pernicious anemia and folate deficiency), thalassemia major, sickle cell disease or myelodysplastic syndrome.\n * Evidence of actively bleeding gastric, duodenal, or esophageal ulcer disease or clinically significant gastrointestinal (GI) bleeding <= 8 weeks prior to screening through to randomization (Day 1).\n * History of severe allergic or anaphylactic reactions or hypersensitivity to excipients in the investigational product.\n * Use of strong inhibitor of CYP2C8 (for example, gemfibrozil) or strong inducers of CYP2C8 (for example, rifampin/rifampicin).\n * Ferric citrate use within 4 weeks prior to randomization (Day 1).\n * Use of other investigational agent or device prior to screening through to randomization (Day 1).\n * Any prior treatment with daprodustat for a treatment duration of >30 days.\n * MI or acute coronary syndrome within the 8 weeks prior to screening through to randomization. (Day 1).\n * Stroke or transient ischemic attack within the 8 weeks prior to screening through to randomization. (Day 1).\n * Chronic Class IV heart failure, as defined by the New York Heart Association (NYHA) functional classification system.\n * QT interval corrected by Bazett's formula (QTcB) >500 milliseconds (msec) or QTcB >530 msec in participants with bundle branch block. There is no corrected QT interval (QTc) exclusion for participants with a predominantly paced rhythm.\n * Alanine transaminase (ALT) >2x upper limit of normal (ULN) at screening (Week -4).\n * Bilirubin >1.5xULN at screening (Week -4).\n * Current unstable liver or biliary disease per investigator assessment, generally defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis.\n * History of malignancy within the 2 years prior to screening through to randomization (Day 1), or currently receiving treatment for cancer, or complex kidney cyst (for example, Bosniak Category II F, III or IV) > 3 centimeters (cm).\n * Any other condition, clinical or laboratory abnormality, or examination finding that the investigator considers would put the participant at unacceptable risk, which may affect study compliance or prevent understanding of the aims or investigational procedures or possible consequences of the study.\n * Current uncontrolled hypertension as determined by the investigator.","EGFR","epidermal growth factor receptor","Protein","Ovary, Breast, Lung","Actual","2018-01-24","Actual","Anticipated","2020-10-06","Anticipated","2020-03-01","2018-01-08","2018-01-17","2020-03-20","No","Non-Dialysis\nAnemia\nChronic kidney disease\nRecombinant human erythropoietin naÃ¯ve\nHemoglobin\nDaprodustat","Interventional","Treatment","Parallel Assignment","Double (Participant, Investigator)","Randomized","18 Years",null,"All",null,"No","Yes\nIPD for this study will be made available via the Clinical Study Data Request site.",{"$nulls":3},"Yes","No",{"$nulls":17},"2017-002270-39","EudraCT Number","Mean change from Baseline in Hgb up to evaluation period (EP)","The EP is from Week 24 to Week 28.","Baseline and up to Week 28","Percentage of participants with Hgb increase of >=1.0 grams per deciliter (g/dL) from Baseline|Mean change from Baseline in short form-36 (SF-36) questionnaire vitality domain score|Percentage of Hgb responders|Percentage time Hgb in range|Mean change from Baseline for additional Hgb parameters|Time to rescue|Mean change from Baseline in CKD - Anemia Questionnaire (CKD-AQ) score|Change from Baseline in Patient Global Impression of Severity (PGI-S) score|Mean change from Baseline in SF-36 questionnaire vitality domain score|Mean change from Baseline in SF-36 questionnaire physical function domain score|Percentage of participants currently employed on the work productivity and activity impairment, anemia symptoms, clinical practice version (WPAI-ANS-CPV) scale|Change from Baseline in percent mean hours work time missed on the WPAI-ANS|CPV change from Baseline in percent impaired on the WPAI-ANS-CPV questionnaire|Change from Baseline in overall percent work impairment on the WPAI-ANS-CPV questionnaire|Change from Baseline in percent activity impairment on the WPAI-ANS-CPV questionnaire|Change from Baseline in EuroQol 5 Dimension 5 Level Health Utility Index (EQ-5D-5L) score|Change from Baseline EuroQol Visual Analogue Scale (EQ-VAS) score|Change from Baseline in systolic blood pressure (SBP), diastolic blood pressure (DBP) and mean arterial pressure (MAP) at Week 28|Percentage of participants with at least one BP exacerbation|Other Pre-specified Outcome Measures:|Incidences and severity of adverse events (AEs) and serious AEs (SAEs)","Percentage (%) of participants having a Hgb increase of >=1.0 g/dL from Baseline to EP.|Mean Change in SF-36 Vitality domain score between Baseline and Week 28.|Responders will be defined as percentage of participants whose mean Hgb is within target range.|Percentage time of Hgb within the target range will be analyzed.|Mean change in Hgb from Baseline to Week 28.|Time to rescue is defined as time to permanently stopping randomized treatment due to meeting rescue criteria.|Mean change from Baseline to week 28 by domain and overall symptom score on the CKD-AQ symptom questionnaire.|Change from Baseline to Week 28 in the severity and change in symptoms by PGI-S score.|Mean Change in individual items of the SF-36 vitality domain score between Baseline and Week 28 will be analyzed.|Mean Change in SF-36 physical function domain score between Baseline and Week 28 will be analyzed.|Percentage of participants currently employed on WPAI-ANS-CPV; questionnaire will be analyzed.|Change from Baseline in percent mean hours work time missed using WPAI-ANS-CPV questionnaire will be analyzed.|CPV change from Baseline in percent impaired on the WPAI-ANS-CPV questionnaire will be analyzed.|Change from Baseline in overall percent work impairment using the WPAI-ANS-CPV questionnaire will be analyzed.|Change from Baseline in percent activity impairment using WPAI-ANS-CPV will be analyzed.|Change from Baseline to Week 28 in health status by EQ-5D-5L score.|Change from Baseline to Week 28 in EQ-VAS score.|Change from Baseline in SBP, DBP and MAP at Week 28 will be analyzed.|Percentage of participants with at least one BP exacerbation during the study will be analyzed.|Other Pre-specified Outcome Measures:|Includes AEs of special interest and adjudicated Major adverse cardiovascular event (MACE) (composite of all-cause mortality, non-fatal Myocardial infarction","Baseline and up to Week 28|Baseline and Week 28|Up to Week 28|Baseline and at Week 28|MI and non-fatal stroke).",{"$nulls":3},"Ciudad Autonoma De Buenos Aires, Buenos Aires, Argentina, C1128Aaf Gsk Investigational SiteCiudad Autonoma De Buenos Aires, Buenos Aires, Argentina, C1425Agc Gsk Investigational SiteMar Del Plata, Buenos Aires, Argentina, 7600 Gsk Investigational SiteMar Del Plata, Buenos Aires, Argentina, B7600Fzn Gsk Investigational SiteSan Nicolas, Buenos Aires, Argentina, B2900Dmh|Cordoba, CÃ³rdova, Argentina, 5003|Santa Fe, Argentina, 3000|Rosario, Santa Fe, Argentina, S2000Dej|Fitzroy, Australia, 3065|Murdoch, Western|Sydney, New South Wales, Australia, 2010|Heidelberg, Victoria, Australia, 3084 Gsk Investigational SiteParkville, Victoria, Australia, 3050|Feira De Santana., Bahia, Brazil, 44001-584 Gsk Investigational SiteSalvador, Bahia, Brazil, 40415-065|Vitoria, EspÃ­rito Santo, Brazil, 29055450|SÃ£o Paulo, Brazil, 04038002|RibeirÃ£o Preto, SÃ£o Paulo, Brazil, 14025170 Gsk Investigational SiteSanto AndrÃ© - Sp, SÃ£o Paulo, Brazil, 09080-110 Gsk Investigational SiteSao Jose Do Rio Preto, SÃ£o Paulo, Brazil, 15015200 Gsk Investigational SiteSao Jose Do Rio Preto, SÃ£o Paulo, Brazil, 15090-000 Gsk Investigational SiteSÃ£o Bernardo Do Campo, SÃ£o Paulo, Brazil, 09715090|Victoria, British Columbia, Canada, V8V 4A1|Quebec, Canada, G3K 2P8|Brampton, Ontario, Canada, L6T 0G1 Gsk Investigational SiteGuelph, Ontario, Canada, N1H 1B1 Gsk Investigational SiteKitchener, Ontario, Canada, N2H 5Z8 Gsk Investigational SiteOttawa, Ontario, Canada, K1H 1A2 Gsk Investigational SiteSarnia, Ontario, Canada, N7T 4X3 Gsk Investigational SiteSudbury, Ontario, Canada Gsk Investigational SiteToronto, Ontario, Canada, M5B 1W8 Gsk Investigational SiteToronto, Ontario, Canada, M9N 1N8 Gsk Investigational SiteToronto, Ontario, Canada, M9V 4B4|MontrÃ©al, Quebec, Canada, H1M 1B1 Gsk Investigational SiteQuebec City, Quebec, Canada, G2J 0C4 Gsk Investigational SiteSt-Charles-BorromÃ©e, Quebec, Canada, J6E 2B4|Grenoble Cedex 9, France, 38043 Gsk Investigational SiteLe Mans Cedex 9, France, 72037 Gsk Investigational SiteMarseille Cedex 5, France, 13385 Gsk Investigational SiteMelun, France, 77000 Gsk Investigational SiteMulhouse Cedex, France, 68070 Gsk Investigational SiteNantes Cedex 1, France, 44093 Gsk Investigational SiteNice Cedex 1, France, 06001 Gsk Investigational SiteSaint-Priest En Jarez, France, 42270|Catanzaro, Calabria, Italy, 88100|Napoli, Campania, Italy, 80131|Bologna, Emilia-Romagna, Italy, 40138 Gsk Investigational SiteModena, Emilia-Romagna, Italy, 41124|Genova, Liguria, Italy, 16132|Pavia, Lombardia, Italy, 27100|Mestre, Veneto, Italy, 30174 Korea, Republic Of Gsk Investigational SiteBusan, Korea, Republic Of, 49201 Gsk Investigational SiteBusan, Korea, Republic Of, 49241 Gsk Investigational SiteDaegu-Si, Korea, Republic Of, 42601 Gsk Investigational SiteDaegu, Korea, Republic Of, 42415 Gsk Investigational SiteGyeonggi-Do, Korea, Republic Of, 463-712 Gsk Investigational SiteSeongnam-Si, Gyeonggi-Do, Korea, Republic Of, 13620 Gsk Investigational SiteSeoul, Korea, Republic Of, 03312 Gsk Investigational SiteSeoul, Korea, Republic Of, 08308|Guadalajara, Mexico, 44600 Gsk Investigational SiteMerida, Mexico, 97000 Gsk Investigational SiteVeracruz, Mexico, 91900|Leon, Guanajuato, Mexico, 37390|Guadalajara, Jalisco, Mexico, 44150|Monterrey, Nuevo LeÃ³n, Mexico, 64060|Boca Del Rio, Veracruz, Mexico, 24290 Gsk Investigational SiteCÃ³rdoba, Veracruz, Mexico, 94550|Merida, YucatÃ¡n, Mexico, 97070|Bialystok, Poland, 15-276 Gsk Investigational SiteCiechanow, Poland, 06-400 Gsk Investigational SiteKrakow, Poland, 30510 Gsk Investigational SiteKrakow, Poland, 31-513 Gsk Investigational SiteKrakow, Poland, 31-559 Gsk Investigational SiteLodz, Poland, 92-213 Gsk Investigational SiteLublin, Poland, 20-068 Gsk Investigational SiteOlawa, Poland, 55-200 Gsk Investigational SitePleszew, Poland, 63-300 Gsk Investigational SiteSosnowiec, Poland, 41-200 Gsk Investigational SiteSwidnik, Poland, 21-040 Gsk Investigational SiteSzczecin, Poland, 70-111 Gsk Investigational SiteTczew, Poland, 83-110 Gsk Investigational SiteWarszawa, Poland, 01-868 Gsk Investigational SiteWarszawa, Poland, 02-801 Gsk Investigational SiteWarszawa, Poland, 04-749|Brasov, Romania, 500283 Gsk Investigational SiteBucharest, Romania, 022328 Gsk Investigational SiteBucharest, Romania, 022328 Gsk Investigational SiteBucharest, Romania, 042122 Gsk Investigational SiteCluj-Napoca, Romania, 400139 Gsk Investigational SiteCraiova, Romania, 200642 Gsk Investigational SiteDeva, Romania, 330084 Gsk Investigational SiteOradea, Romania, 410469 Gsk Investigational SiteTargu Mures, Romania, 540096 Gsk Investigational SiteTimisoara, Romania, 300723 Russian Federation Gsk Investigational SiteIzhevsk, Russian Federation, 426061 Gsk Investigational SiteKaliningrad, Russian Federation, 236016 Gsk Investigational SiteKemerovo, Russian Federation, 650066 Gsk Investigational SiteKrasnoyarsk, Russian Federation, 660022 Gsk Investigational SiteMoscow, Russian Federation, 121359 Gsk Investigational SiteNizhniy Novgorod, Russian Federation, 603126 Gsk Investigational SitePyatigorsk, Russian Federation, 357500 Gsk Investigational SitePyatigorsk, Russian Federation, 357538 Gsk Investigational SiteRostov-On-Don, Russian Federation, 344022 Gsk Investigational SiteRyazan, Russian Federation, 390037 Gsk Investigational SiteSaint Petersburg, Russian Federation, 194355 Gsk Investigational SiteSaint Petersburg, Russian Federation, 197022 Gsk Investigational SiteStavropol, Russian Federation, 355017 Gsk Investigational SiteYaroslavl, Russian Federation, 150000 Gsk Investigational SiteYaroslavl, Russian Federation, 150030 Gsk Investigational SiteYaroslavl, Russian Federation, 150062|Badalona, Spain, 08916 Gsk Investigational SiteMadrid, Spain, 28040 Gsk Investigational SiteSantiago De Compostela, Spain|Canterbury, Kent, United Kingdom, Ct1 3Ng|Derby, United Kingdom, De22 3Ne Gsk Investigational SiteLondon, United Kingdom, Se5 9Rs Gsk Investigational SitePeterborough, United Kingdom, Pe3 9Gz Gsk Investigational SitePlymouth, United Kingdom, Pl6 8Dh Gsk Investigational SiteShrewsbury, United Kingdom, Sy3 8Xq Gsk Investigational SiteSwansea, United Kingdom, Sa6 6Nl|Homewood, Alabama, United States, 35209|Little Rock, Arkansas, United States, 72204|Downey, California, United States, 90242 Gsk Investigational SiteFresno, California, United States, 93720 Gsk Investigational SiteLynwood, California, United States, 90262 Gsk Investigational SiteNorthridge, California, United States, 91324 Gsk Investigational SiteNorthridge, California, United States, 91325 Gsk Investigational SiteRiverside, California, United States, 82503 Gsk Investigational SiteSalinas, California, United States, 93901 Gsk Investigational SiteSanta Ana, California, United States, 92704|Denver, Colorado, United States, 80230|Hartford, Connecticut, United States, 06112 Gsk Investigational SiteMiddlebury, Connecticut, United States, 06762|Coral Springs, Florida, United States, 33067 Gsk Investigational SiteHollywood, Florida, United States, 33021-5424 Gsk Investigational SiteHollywood, Florida, United States, 33024 Gsk Investigational SiteKissimmee, Florida, United States, 34741 Gsk Investigational SiteLauderdale Lakes, Florida, United States, 33313 Gsk Investigational SiteTampa, Florida, United States, 33614|Adairsville, Georgia, United States, 30103 Gsk Investigational SiteMacon, Georgia, United States, 31201 Gsk Investigational SiteMacon, Georgia, United States, 31217 Gsk Investigational SiteStatesboro, Georgia, United States, 30458|Indianapolis, Indiana, United States, 46260|Overland Park, Kansas, United States, 66210|Buckley, Michigan, United States, 49620 Gsk Investigational SiteDetroit, Michigan, United States, 48202 Gsk Investigational SiteSaint Clair Shores, Michigan, United States, 48081|Brookhaven, Mississippi, United States, 39601|Saint Louis, Missouri, United States, 63136|Portsmouth, New Hampshire, United States, 03801|Asheville, North Carolina, United States, 28801 Gsk Investigational SiteCharlotte, North Carolina, United States, 28262 Gsk Investigational SiteDurham, North Carolina, United States, 27704|Midwest City, Oklahoma, United States, 73130 Gsk Investigational SiteOklahoma City, Oklahoma, United States, 73112|Beaver, Pennsylvania, United States, 15009 Gsk Investigational SiteDuncansville, Pennsylvania, United States, 16635 Gsk Investigational SiteJersey Shore, Pennsylvania, United States, 17740 Gsk Investigational SiteScottdale, Pennsylvania, United States, 15683 Gsk Investigational SiteSmithfield, Pennsylvania, United States, 15478 Gsk Investigational SiteWest Reading, Pennsylvania, United States, 19611|Orangeburg, South Carolina, United States, 29118|Kingsport, Tennessee, United States, 37660 Gsk Investigational SiteMemphis, Tennessee, United States, 38163|Desoto, Texas, United States, 75115 Gsk Investigational SiteEl Paso, Texas, United States, 79935 Gsk Investigational SiteMcallen, Texas, United States, 78503 Gsk Investigational SiteWaxahachie, Texas, United States, 75165|Norfolk, Virginia, United States, 23502","Alabama|Arkansas|California|Colorado|Connecticut|Florida|Georgia|Indiana|Kansas|Michigan|Mississippi|Missouri|New Hampshire|North Carolina|Oklahoma|Pennsylvania|South Carolina|Tennessee|Texas|Virginia","Argentina|Australia|Brazil|Canada|France|Italy|Mexico|Poland|Romania|Spain|United Kingdom|United States","Buenos Aires Gsk Investigational Site|CÃ³rdova Gsk Investigational Site|Gsk Investigational Site|Santa Fe Gsk Investigational Site|New South Wales Gsk Investigational Site|Victoria Gsk Investigational Site|Bahia Gsk Investigational Site|EspÃ­rito Santo Gsk Investigational Site|SÃ£o Paulo Gsk Investigational Site|British Columbia Gsk Investigational Site|Ontario Gsk Investigational Site|Quebec Gsk Investigational Site|Calabria Gsk Investigational Site|Campania Gsk Investigational Site|Emilia-Romagna Gsk Investigational Site|Liguria Gsk Investigational Site|Lombardia Gsk Investigational Site|Veneto Gsk Investigational Site|Guanajuato Gsk Investigational Site|Jalisco Gsk Investigational Site|Nuevo LeÃ³n Gsk Investigational Site|Veracruz Gsk Investigational Site|YucatÃ¡n Gsk Investigational Site|, Kent Gsk Investigational Site",{"$nulls":3},"GSK Clinical Trials","2020-03-20","2020-05-25T16:38:30.276","2020-05-26T17:10:42.972","NCT03409107"]
["5ecbf486feab101b15530960","NCT03409107","2020-04-13","GlaxoSmithKline","GSK","Active, not recruiting","Anemia Studies in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat in Non-Dialysis Subjects Evaluating Hemoglobin (Hgb) and Quality of Life (ASCEND-NHQ)","Daprodustat","HIF Inhibitor","Yes","['Daprodustat']","Yes","['HIF Inhibitor']","Phase 3",2,600,"Anticipated","2018-03-05","2020-10-06",{"$nulls":5},"The purpose of this multi-center study in non-dialysis participants with anemia associated with CKD is to evaluate safety, efficacy and quality of life of daprodustat compared to placebo.",null,"A 28-week, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center, Study in Recombinant Human Erythropoietin (rhEPO) naÃ¯ve Non-dialysis Participants With Anemia Associated With Chronic Kidney Disease to Evaluate the Efficacy, Safety and Effects on Quality of Life of Daprodustat Compared to Placebo",205270,"Anaemia","Anemia|Hemoglobin C Disease|Hemoglobin SC Disease","Hematologic Diseases","Heme & Lymph Diseases","Experimental|Placebo Comparator","Daprodustat receivers|Placebo receivers","Participants will receive oral daprodustat once daily|Participants will receive oral placebo once daily","Drug","Daprodustat (GSK1278863)|Iron therapy|Placebo","Daprodustat will be available as 9 millimeter (mm) or 7 mm film-coated tablets. Daprodustat will be administered once daily via oral route and can be taken without regard to food.|Iron therapy will be administered if ferritin is <50 Nano gram per milliliter and/or TSAT is <15 percent.|Daprodustat matching placebo will be available as 9 mm or 7 mm film coated tablets. Placebo will be administered once daily via oral route and can be taken without regard to food.",null,"Daprodustat receivers|Placebo receivers","\n\n * >=18 years of age at the time of signing the informed consent.\n * Have CKD, confirmed at screening: Kidney Disease Outcomes Quality Initiative (KDOQI) CKD stages 3, 4, or 5 defined by Estimated glomerular filtration rate (eGFR) using the CKD Epidemiology Collaboration (CKD-EPI) formula.\n * Participants with Stable HemoCue Hgb from 8.5 to 10.5 at screening visit (Week -4) and from 8.5 to 10.0 g/dL at randomization (Day 1).\n * Participants may receive up to one intravenous (IV) iron dose within the 8 weeks prior to screening and NO IV iron use between screening visit and randomization (Day 1).\n * If needed, participant may be on stable maintenance oral iron supplementation. There should be <50% change in overall dose and no change in type of iron prescribed in the 4 weeks prior to Day 1 randomization visit.\n * Male and female participants are eligible. A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: Not a woman of childbearing potential (WOCBP) or WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 4 weeks after the last dose of study treatment.\n * Capable of giving signed informed consent.\n\n","\n\n * Participants who are on dialysis or clinical evidence of impending need to initiate dialysis within 180 days after randomization (Day 1).\n * Planned living-related or living-unrelated kidney transplant within 28 weeks after randomization (Day 1).\n * Transferrin saturation (TSAT) <15 percent (Screening only).\n * Ferritin <50 nanograms per milliliter (ng/mL) (Screening only).\n * History of rhEPO or rhEPO analogue use within the 8 weeks prior to screening and rhEPO use between screening and randomization (Day 1).\n * History of transfusion within the 8 weeks prior to screening and transfusion between screening and randomization (Day 1).\n * History of bone marrow aplasia or pure red cell aplasia (PRCA).\n * Participants with Megaloblastic anemia (untreated pernicious anemia and folate deficiency), thalassemia major, sickle cell disease or myelodysplastic syndrome.\n * Evidence of actively bleeding gastric, duodenal, or esophageal ulcer disease or clinically significant gastrointestinal (GI) bleeding <= 8 weeks prior to screening through to randomization (Day 1).\n * History of severe allergic or anaphylactic reactions or hypersensitivity to excipients in the investigational product.\n * Use of strong inhibitor of CYP2C8 (for example, gemfibrozil) or strong inducers of CYP2C8 (for example, rifampin/rifampicin).\n * Ferric citrate use within 4 weeks prior to randomization (Day 1).\n * Use of other investigational agent or device prior to screening through to randomization (Day 1).\n * Any prior treatment with daprodustat for a treatment duration of >30 days.\n * MI or acute coronary syndrome within the 8 weeks prior to screening through to randomization. (Day 1).\n * Stroke or transient ischemic attack within the 8 weeks prior to screening through to randomization. (Day 1).\n * Chronic Class IV heart failure, as defined by the New York Heart Association (NYHA) functional classification system.\n * QT interval corrected by Bazett's formula (QTcB) >500 milliseconds (msec) or QTcB >530 msec in participants with bundle branch block. There is no corrected QT interval (QTc) exclusion for participants with a predominantly paced rhythm.\n * Alanine transaminase (ALT) >2x upper limit of normal (ULN) at screening (Week -4).\n * Bilirubin >1.5xULN at screening (Week -4).\n * Current unstable liver or biliary disease per investigator assessment, generally defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis.\n * History of malignancy within the 2 years prior to screening through to randomization (Day 1), or currently receiving treatment for cancer, or complex kidney cyst (for example, Bosniak Category II F, III or IV) > 3 centimeters (cm).\n * Any other condition, clinical or laboratory abnormality, or examination finding that the investigator considers would put the participant at unacceptable risk, which may affect study compliance or prevent understanding of the aims or investigational procedures or possible consequences of the study.\n * Current uncontrolled hypertension as determined by the investigator.","EGFR","epidermal growth factor receptor","Protein","Ovary, Breast, Lung","Actual","2018-01-24","Actual","Anticipated","2020-10-06","Anticipated","2020-04-01","2018-01-08","2018-01-17","2020-04-10","No","Non-Dialysis\nAnemia\nChronic kidney disease\nRecombinant human erythropoietin naÃ¯ve\nHemoglobin\nDaprodustat","Interventional","Treatment","Parallel Assignment","Double (Participant, Investigator)","Randomized","18 Years",null,"All",null,"No","Yes\nIPD for this study will be made available via the Clinical Study Data Request site.",{"$nulls":3},"Yes","No",{"$nulls":17},"2017-002270-39","EudraCT Number","Mean change from Baseline in Hgb up to evaluation period (EP)","The EP is from Week 24 to Week 28.","Baseline and up to Week 28","Percentage of participants with Hgb increase of >=1.0 grams per deciliter (g/dL) from Baseline|Mean change from Baseline in short form-36 (SF-36) questionnaire vitality domain score|Percentage of Hgb responders|Percentage time Hgb in range|Mean change from Baseline for additional Hgb parameters|Time to rescue|Mean change from Baseline in CKD - Anemia Questionnaire (CKD-AQ) score|Change from Baseline in Patient Global Impression of Severity (PGI-S) score|Mean change from Baseline in SF-36 questionnaire vitality domain score|Mean change from Baseline in SF-36 questionnaire physical function domain score|Percentage of participants currently employed on the work productivity and activity impairment, anemia symptoms, clinical practice version (WPAI-ANS-CPV) scale|Change from Baseline in percent mean hours work time missed on the WPAI-ANS|CPV change from Baseline in percent impaired on the WPAI-ANS-CPV questionnaire|Change from Baseline in overall percent work impairment on the WPAI-ANS-CPV questionnaire|Change from Baseline in percent activity impairment on the WPAI-ANS-CPV questionnaire|Change from Baseline in EuroQol 5 Dimension 5 Level Health Utility Index (EQ-5D-5L) score|Change from Baseline EuroQol Visual Analogue Scale (EQ-VAS) score|Change from Baseline in systolic blood pressure (SBP), diastolic blood pressure (DBP) and mean arterial pressure (MAP) at Week 28|Percentage of participants with at least one BP exacerbation|Other Pre-specified Outcome Measures:|Incidences and severity of adverse events (AEs) and serious AEs (SAEs)","Percentage (%) of participants having a Hgb increase of >=1.0 g/dL from Baseline to EP.|Mean Change in SF-36 Vitality domain score between Baseline and Week 28.|Responders will be defined as percentage of participants whose mean Hgb is within target range.|Percentage time of Hgb within the target range will be analyzed.|Mean change in Hgb from Baseline to Week 28.|Time to rescue is defined as time to permanently stopping randomized treatment due to meeting rescue criteria.|Mean change from Baseline to week 28 by domain and overall symptom score on the CKD-AQ symptom questionnaire.|Change from Baseline to Week 28 in the severity and change in symptoms by PGI-S score.|Mean Change in individual items of the SF-36 vitality domain score between Baseline and Week 28 will be analyzed.|Mean Change in SF-36 physical function domain score between Baseline and Week 28 will be analyzed.|Percentage of participants currently employed on WPAI-ANS-CPV; questionnaire will be analyzed.|Change from Baseline in percent mean hours work time missed using WPAI-ANS-CPV questionnaire will be analyzed.|CPV change from Baseline in percent impaired on the WPAI-ANS-CPV questionnaire will be analyzed.|Change from Baseline in overall percent work impairment using the WPAI-ANS-CPV questionnaire will be analyzed.|Change from Baseline in percent activity impairment using WPAI-ANS-CPV will be analyzed.|Change from Baseline to Week 28 in health status by EQ-5D-5L score.|Change from Baseline to Week 28 in EQ-VAS score.|Change from Baseline in SBP, DBP and MAP at Week 28 will be analyzed.|Percentage of participants with at least one BP exacerbation during the study will be analyzed.|Other Pre-specified Outcome Measures:|Includes AEs of special interest and adjudicated Major adverse cardiovascular event (MACE) (composite of all-cause mortality, non-fatal Myocardial infarction","Baseline and up to Week 28|Baseline and Week 28|Up to Week 28|Baseline and at Week 28|MI and non-fatal stroke).",{"$nulls":3},"Ciudad Autonoma De Buenos Aires, Buenos Aires, Argentina, C1128Aaf Gsk Investigational SiteCiudad Autonoma De Buenos Aires, Buenos Aires, Argentina, C1425Agc Gsk Investigational SiteMar Del Plata, Buenos Aires, Argentina, 7600 Gsk Investigational SiteMar Del Plata, Buenos Aires, Argentina, B7600Fzn Gsk Investigational SiteSan Nicolas, Buenos Aires, Argentina, B2900Dmh|Cordoba, CÃ³rdova, Argentina, 5003|Santa Fe, Argentina, 3000|Rosario, Santa Fe, Argentina, S2000Dej|Fitzroy, Australia, 3065|Murdoch, Western|Sydney, New South Wales, Australia, 2010|Heidelberg, Victoria, Australia, 3084 Gsk Investigational SiteParkville, Victoria, Australia, 3050|Feira De Santana., Bahia, Brazil, 44001-584 Gsk Investigational SiteSalvador, Bahia, Brazil, 40415-065|Vitoria, EspÃ­rito Santo, Brazil, 29055450|SÃ£o Paulo, Brazil, 04038002|RibeirÃ£o Preto, SÃ£o Paulo, Brazil, 14025170 Gsk Investigational SiteSanto AndrÃ© - Sp, SÃ£o Paulo, Brazil, 09080-110 Gsk Investigational SiteSao Jose Do Rio Preto, SÃ£o Paulo, Brazil, 15015200 Gsk Investigational SiteSao Jose Do Rio Preto, SÃ£o Paulo, Brazil, 15090-000 Gsk Investigational SiteSÃ£o Bernardo Do Campo, SÃ£o Paulo, Brazil, 09715090|Victoria, British Columbia, Canada, V8V 4A1|Quebec, Canada, G3K 2P8|Brampton, Ontario, Canada, L6T 0G1 Gsk Investigational SiteGuelph, Ontario, Canada, N1H 1B1 Gsk Investigational SiteKitchener, Ontario, Canada, N2H 5Z8 Gsk Investigational SiteOttawa, Ontario, Canada, K1H 1A2 Gsk Investigational SiteSarnia, Ontario, Canada, N7T 4X3 Gsk Investigational SiteSudbury, Ontario, Canada Gsk Investigational SiteToronto, Ontario, Canada, M5B 1W8 Gsk Investigational SiteToronto, Ontario, Canada, M9N 1N8 Gsk Investigational SiteToronto, Ontario, Canada, M9V 4B4|MontrÃ©al, Quebec, Canada, H1M 1B1 Gsk Investigational SiteQuebec City, Quebec, Canada, G2J 0C4 Gsk Investigational SiteSt-Charles-BorromÃ©e, Quebec, Canada, J6E 2B4|Grenoble Cedex 9, France, 38043 Gsk Investigational SiteLe Mans Cedex 9, France, 72037 Gsk Investigational SiteMarseille Cedex 5, France, 13385 Gsk Investigational SiteMelun, France, 77000 Gsk Investigational SiteMulhouse Cedex, France, 68070 Gsk Investigational SiteNantes Cedex 1, France, 44093 Gsk Investigational SiteNice Cedex 1, France, 06001 Gsk Investigational SiteSaint-Priest En Jarez, France, 42270|Catanzaro, Calabria, Italy, 88100|Napoli, Campania, Italy, 80131|Bologna, Emilia-Romagna, Italy, 40138 Gsk Investigational SiteModena, Emilia-Romagna, Italy, 41124|Genova, Liguria, Italy, 16132|Pavia, Lombardia, Italy, 27100|Mestre, Veneto, Italy, 30174 Korea, Republic Of Gsk Investigational SiteBusan, Korea, Republic Of, 49201 Gsk Investigational SiteBusan, Korea, Republic Of, 49241 Gsk Investigational SiteDaegu-Si, Korea, Republic Of, 42601 Gsk Investigational SiteDaegu, Korea, Republic Of, 42415 Gsk Investigational SiteGyeonggi-Do, Korea, Republic Of, 463-712 Gsk Investigational SiteSeongnam-Si, Gyeonggi-Do, Korea, Republic Of, 13620 Gsk Investigational SiteSeoul, Korea, Republic Of, 03312 Gsk Investigational SiteSeoul, Korea, Republic Of, 08308|Guadalajara, Mexico, 44600 Gsk Investigational SiteMerida, Mexico, 97000 Gsk Investigational SiteVeracruz, Mexico, 91900|Leon, Guanajuato, Mexico, 37390|Guadalajara, Jalisco, Mexico, 44150|Monterrey, Nuevo LeÃ³n, Mexico, 64060|Boca Del Rio, Veracruz, Mexico, 24290 Gsk Investigational SiteCÃ³rdoba, Veracruz, Mexico, 94550|Merida, YucatÃ¡n, Mexico, 97070|Bialystok, Poland, 15-276 Gsk Investigational SiteCiechanow, Poland, 06-400 Gsk Investigational SiteKrakow, Poland, 30510 Gsk Investigational SiteKrakow, Poland, 31-513 Gsk Investigational SiteKrakow, Poland, 31-559 Gsk Investigational SiteLodz, Poland, 92-213 Gsk Investigational SiteLublin, Poland, 20-068 Gsk Investigational SiteOlawa, Poland, 55-200 Gsk Investigational SitePleszew, Poland, 63-300 Gsk Investigational SiteSosnowiec, Poland, 41-200 Gsk Investigational SiteSwidnik, Poland, 21-040 Gsk Investigational SiteSzczecin, Poland, 70-111 Gsk Investigational SiteTczew, Poland, 83-110 Gsk Investigational SiteWarszawa, Poland, 01-868 Gsk Investigational SiteWarszawa, Poland, 02-801 Gsk Investigational SiteWarszawa, Poland, 04-749|Brasov, Romania, 500283 Gsk Investigational SiteBucharest, Romania, 022328 Gsk Investigational SiteBucharest, Romania, 022328 Gsk Investigational SiteBucharest, Romania, 042122 Gsk Investigational SiteCluj-Napoca, Romania, 400139 Gsk Investigational SiteCraiova, Romania, 200642 Gsk Investigational SiteDeva, Romania, 330084 Gsk Investigational SiteOradea, Romania, 410469 Gsk Investigational SiteTargu Mures, Romania, 540096 Gsk Investigational SiteTimisoara, Romania, 300723 Russian Federation Gsk Investigational SiteIzhevsk, Russian Federation, 426061 Gsk Investigational SiteKaliningrad, Russian Federation, 236016 Gsk Investigational SiteKemerovo, Russian Federation, 650066 Gsk Investigational SiteKrasnoyarsk, Russian Federation, 660022 Gsk Investigational SiteMoscow, Russian Federation, 121359 Gsk Investigational SiteNizhniy Novgorod, Russian Federation, 603126 Gsk Investigational SitePyatigorsk, Russian Federation, 357500 Gsk Investigational SitePyatigorsk, Russian Federation, 357538 Gsk Investigational SiteRostov-On-Don, Russian Federation, 344022 Gsk Investigational SiteRyazan, Russian Federation, 390037 Gsk Investigational SiteSaint Petersburg, Russian Federation, 194355 Gsk Investigational SiteSaint Petersburg, Russian Federation, 197022 Gsk Investigational SiteStavropol, Russian Federation, 355017 Gsk Investigational SiteYaroslavl, Russian Federation, 150000 Gsk Investigational SiteYaroslavl, Russian Federation, 150030 Gsk Investigational SiteYaroslavl, Russian Federation, 150062|Badalona, Spain, 08916 Gsk Investigational SiteMadrid, Spain, 28040 Gsk Investigational SiteSantiago De Compostela, Spain|Canterbury, Kent, United Kingdom, Ct1 3Ng|Derby, United Kingdom, De22 3Ne Gsk Investigational SiteLondon, United Kingdom, Se5 9Rs Gsk Investigational SitePeterborough, United Kingdom, Pe3 9Gz Gsk Investigational SitePlymouth, United Kingdom, Pl6 8Dh Gsk Investigational SiteShrewsbury, United Kingdom, Sy3 8Xq Gsk Investigational SiteSwansea, United Kingdom, Sa6 6Nl|Homewood, Alabama, United States, 35209|Little Rock, Arkansas, United States, 72204|Downey, California, United States, 90242 Gsk Investigational SiteFresno, California, United States, 93720 Gsk Investigational SiteLynwood, California, United States, 90262 Gsk Investigational SiteNorthridge, California, United States, 91324 Gsk Investigational SiteNorthridge, California, United States, 91325 Gsk Investigational SiteRiverside, California, United States, 82503 Gsk Investigational SiteSalinas, California, United States, 93901 Gsk Investigational SiteSanta Ana, California, United States, 92704|Denver, Colorado, United States, 80230|Hartford, Connecticut, United States, 06112 Gsk Investigational SiteMiddlebury, Connecticut, United States, 06762|Coral Springs, Florida, United States, 33067 Gsk Investigational SiteHollywood, Florida, United States, 33021-5424 Gsk Investigational SiteHollywood, Florida, United States, 33024 Gsk Investigational SiteKissimmee, Florida, United States, 34741 Gsk Investigational SiteLauderdale Lakes, Florida, United States, 33313 Gsk Investigational SiteTampa, Florida, United States, 33614|Adairsville, Georgia, United States, 30103 Gsk Investigational SiteMacon, Georgia, United States, 31201 Gsk Investigational SiteMacon, Georgia, United States, 31217 Gsk Investigational SiteStatesboro, Georgia, United States, 30458|Indianapolis, Indiana, United States, 46260|Overland Park, Kansas, United States, 66210|Buckley, Michigan, United States, 49620 Gsk Investigational SiteDetroit, Michigan, United States, 48202 Gsk Investigational SiteSaint Clair Shores, Michigan, United States, 48081|Brookhaven, Mississippi, United States, 39601|Saint Louis, Missouri, United States, 63136|Portsmouth, New Hampshire, United States, 03801|Asheville, North Carolina, United States, 28801 Gsk Investigational SiteCharlotte, North Carolina, United States, 28262 Gsk Investigational SiteDurham, North Carolina, United States, 27704|Midwest City, Oklahoma, United States, 73130 Gsk Investigational SiteOklahoma City, Oklahoma, United States, 73112|Beaver, Pennsylvania, United States, 15009 Gsk Investigational SiteDuncansville, Pennsylvania, United States, 16635 Gsk Investigational SiteScottdale, Pennsylvania, United States, 15683 Gsk Investigational SiteSmithfield, Pennsylvania, United States, 15478 Gsk Investigational SiteWest Reading, Pennsylvania, United States, 19611|Orangeburg, South Carolina, United States, 29118|Kingsport, Tennessee, United States, 37660 Gsk Investigational SiteMemphis, Tennessee, United States, 38163|Desoto, Texas, United States, 75115 Gsk Investigational SiteEl Paso, Texas, United States, 79935 Gsk Investigational SiteMcallen, Texas, United States, 78503 Gsk Investigational SiteWaxahachie, Texas, United States, 75165|Norfolk, Virginia, United States, 23502","Alabama|Arkansas|California|Colorado|Connecticut|Florida|Georgia|Indiana|Kansas|Michigan|Mississippi|Missouri|New Hampshire|North Carolina|Oklahoma|Pennsylvania|South Carolina|Tennessee|Texas|Virginia","Argentina|Australia|Brazil|Canada|France|Italy|Mexico|Poland|Romania|Spain|United Kingdom|United States","Buenos Aires Gsk Investigational Site|CÃ³rdova Gsk Investigational Site|Gsk Investigational Site|Santa Fe Gsk Investigational Site|New South Wales Gsk Investigational Site|Victoria Gsk Investigational Site|Bahia Gsk Investigational Site|EspÃ­rito Santo Gsk Investigational Site|SÃ£o Paulo Gsk Investigational Site|British Columbia Gsk Investigational Site|Ontario Gsk Investigational Site|Quebec Gsk Investigational Site|Calabria Gsk Investigational Site|Campania Gsk Investigational Site|Emilia-Romagna Gsk Investigational Site|Liguria Gsk Investigational Site|Lombardia Gsk Investigational Site|Veneto Gsk Investigational Site|Guanajuato Gsk Investigational Site|Jalisco Gsk Investigational Site|Nuevo LeÃ³n Gsk Investigational Site|Veracruz Gsk Investigational Site|YucatÃ¡n Gsk Investigational Site|, Kent Gsk Investigational Site",{"$nulls":3},"GSK Clinical Trials","2020-04-10","2020-05-25T16:38:30.469","2020-05-26T17:10:42.972","NCT03409107"]
["5ecbf486e2561b1b11905e2b","NCT03409107","2020-04-22","GlaxoSmithKline","GSK","Active, not recruiting","Anemia Studies in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat in Non-Dialysis Subjects Evaluating Hemoglobin (Hgb) and Quality of Life (ASCEND-NHQ)","Daprodustat","HIF Inhibitor","Yes","['Daprodustat']","Yes","['HIF Inhibitor']","Phase 3",2,600,"Anticipated","2018-03-05","2020-10-06",{"$nulls":5},"The purpose of this multi-center study in non-dialysis participants with anemia associated with CKD is to evaluate safety, efficacy and quality of life of daprodustat compared to placebo.",null,"A 28-week, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center, Study in Recombinant Human Erythropoietin (rhEPO) naÃ¯ve Non-dialysis Participants With Anemia Associated With Chronic Kidney Disease to Evaluate the Efficacy, Safety and Effects on Quality of Life of Daprodustat Compared to Placebo",205270,"Anaemia","Anemia|Hemoglobin C Disease|Hemoglobin SC Disease","Hematologic Diseases","Heme & Lymph Diseases","Experimental|Placebo Comparator","Daprodustat receivers|Placebo receivers","Participants will receive oral daprodustat once daily|Participants will receive oral placebo once daily","Drug","Daprodustat (GSK1278863)|Iron therapy|Placebo","Daprodustat will be available as 9 millimeter (mm) or 7 mm film-coated tablets. Daprodustat will be administered once daily via oral route and can be taken without regard to food.|Iron therapy will be administered if ferritin is <50 Nano gram per milliliter and/or TSAT is <15 percent.|Daprodustat matching placebo will be available as 9 mm or 7 mm film coated tablets. Placebo will be administered once daily via oral route and can be taken without regard to food.",null,"Daprodustat receivers|Placebo receivers","\n\n * >=18 years of age at the time of signing the informed consent.\n * Have CKD, confirmed at screening: Kidney Disease Outcomes Quality Initiative (KDOQI) CKD stages 3, 4, or 5 defined by Estimated glomerular filtration rate (eGFR) using the CKD Epidemiology Collaboration (CKD-EPI) formula.\n * Participants with Stable HemoCue Hgb from 8.5 to 10.5 at screening visit (Week -4) and from 8.5 to 10.0 g/dL at randomization (Day 1).\n * Participants may receive up to one intravenous (IV) iron dose within the 8 weeks prior to screening and NO IV iron use between screening visit and randomization (Day 1).\n * If needed, participant may be on stable maintenance oral iron supplementation. There should be <50% change in overall dose and no change in type of iron prescribed in the 4 weeks prior to Day 1 randomization visit.\n * Male and female participants are eligible. A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: Not a woman of childbearing potential (WOCBP) or WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 4 weeks after the last dose of study treatment.\n * Capable of giving signed informed consent.\n\n","\n\n * Participants who are on dialysis or clinical evidence of impending need to initiate dialysis within 180 days after randomization (Day 1).\n * Planned living-related or living-unrelated kidney transplant within 28 weeks after randomization (Day 1).\n * Transferrin saturation (TSAT) <15 percent (Screening only).\n * Ferritin <50 nanograms per milliliter (ng/mL) (Screening only).\n * History of rhEPO or rhEPO analogue use within the 8 weeks prior to screening and rhEPO use between screening and randomization (Day 1).\n * History of transfusion within the 8 weeks prior to screening and transfusion between screening and randomization (Day 1).\n * History of bone marrow aplasia or pure red cell aplasia (PRCA).\n * Participants with Megaloblastic anemia (untreated pernicious anemia and folate deficiency), thalassemia major, sickle cell disease or myelodysplastic syndrome.\n * Evidence of actively bleeding gastric, duodenal, or esophageal ulcer disease or clinically significant gastrointestinal (GI) bleeding <= 8 weeks prior to screening through to randomization (Day 1).\n * History of severe allergic or anaphylactic reactions or hypersensitivity to excipients in the investigational product.\n * Use of strong inhibitor of CYP2C8 (for example, gemfibrozil) or strong inducers of CYP2C8 (for example, rifampin/rifampicin).\n * Ferric citrate use within 4 weeks prior to randomization (Day 1).\n * Use of other investigational agent or device prior to screening through to randomization (Day 1).\n * Any prior treatment with daprodustat for a treatment duration of >30 days.\n * MI or acute coronary syndrome within the 8 weeks prior to screening through to randomization. (Day 1).\n * Stroke or transient ischemic attack within the 8 weeks prior to screening through to randomization. (Day 1).\n * Chronic Class IV heart failure, as defined by the New York Heart Association (NYHA) functional classification system.\n * QT interval corrected by Bazett's formula (QTcB) >500 milliseconds (msec) or QTcB >530 msec in participants with bundle branch block. There is no corrected QT interval (QTc) exclusion for participants with a predominantly paced rhythm.\n * Alanine transaminase (ALT) >2x upper limit of normal (ULN) at screening (Week -4).\n * Bilirubin >1.5xULN at screening (Week -4).\n * Current unstable liver or biliary disease per investigator assessment, generally defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis.\n * History of malignancy within the 2 years prior to screening through to randomization (Day 1), or currently receiving treatment for cancer, or complex kidney cyst (for example, Bosniak Category II F, III or IV) > 3 centimeters (cm).\n * Any other condition, clinical or laboratory abnormality, or examination finding that the investigator considers would put the participant at unacceptable risk, which may affect study compliance or prevent understanding of the aims or investigational procedures or possible consequences of the study.\n * Current uncontrolled hypertension as determined by the investigator.","EGFR","epidermal growth factor receptor","Protein","Ovary, Breast, Lung","Actual","2018-01-24","Actual","Anticipated","2020-10-06","Anticipated","2020-04-01","2018-01-08","2018-01-17","2020-04-21","No","Non-Dialysis\nAnemia\nChronic kidney disease\nRecombinant human erythropoietin naÃ¯ve\nHemoglobin\nDaprodustat","Interventional","Treatment","Parallel Assignment","Double (Participant, Investigator)","Randomized","18 Years",null,"All",null,"No","Yes\nIPD for this study will be made available via the Clinical Study Data Request site.",{"$nulls":3},"Yes","No",{"$nulls":17},"2017-002270-39","EudraCT Number","Mean change from Baseline in Hgb up to evaluation period (EP)","The EP is from Week 24 to Week 28.","Baseline and up to Week 28","Percentage of participants with Hgb increase of >=1.0 grams per deciliter (g/dL) from Baseline|Mean change from Baseline in short form-36 (SF-36) questionnaire vitality domain score|Percentage of Hgb responders|Percentage time Hgb in range|Mean change from Baseline for additional Hgb parameters|Time to rescue|Mean change from Baseline in CKD - Anemia Questionnaire (CKD-AQ) score|Change from Baseline in Patient Global Impression of Severity (PGI-S) score|Mean change from Baseline in SF-36 questionnaire vitality domain score|Mean change from Baseline in SF-36 questionnaire physical function domain score|Percentage of participants currently employed on the work productivity and activity impairment, anemia symptoms, clinical practice version (WPAI-ANS-CPV) scale|Change from Baseline in percent mean hours work time missed on the WPAI-ANS|CPV change from Baseline in percent impaired on the WPAI-ANS-CPV questionnaire|Change from Baseline in overall percent work impairment on the WPAI-ANS-CPV questionnaire|Change from Baseline in percent activity impairment on the WPAI-ANS-CPV questionnaire|Change from Baseline in EuroQol 5 Dimension 5 Level Health Utility Index (EQ-5D-5L) score|Change from Baseline EuroQol Visual Analogue Scale (EQ-VAS) score|Change from Baseline in systolic blood pressure (SBP), diastolic blood pressure (DBP) and mean arterial pressure (MAP) at Week 28|Percentage of participants with at least one BP exacerbation|Other Pre-specified Outcome Measures:|Incidences and severity of adverse events (AEs) and serious AEs (SAEs)","Percentage (%) of participants having a Hgb increase of >=1.0 g/dL from Baseline to EP.|Mean Change in SF-36 Vitality domain score between Baseline and Week 28.|Responders will be defined as percentage of participants whose mean Hgb is within target range.|Percentage time of Hgb within the target range will be analyzed.|Mean change in Hgb from Baseline to Week 28.|Time to rescue is defined as time to permanently stopping randomized treatment due to meeting rescue criteria.|Mean change from Baseline to week 28 by domain and overall symptom score on the CKD-AQ symptom questionnaire.|Change from Baseline to Week 28 in the severity and change in symptoms by PGI-S score.|Mean Change in individual items of the SF-36 vitality domain score between Baseline and Week 28 will be analyzed.|Mean Change in SF-36 physical function domain score between Baseline and Week 28 will be analyzed.|Percentage of participants currently employed on WPAI-ANS-CPV; questionnaire will be analyzed.|Change from Baseline in percent mean hours work time missed using WPAI-ANS-CPV questionnaire will be analyzed.|CPV change from Baseline in percent impaired on the WPAI-ANS-CPV questionnaire will be analyzed.|Change from Baseline in overall percent work impairment using the WPAI-ANS-CPV questionnaire will be analyzed.|Change from Baseline in percent activity impairment using WPAI-ANS-CPV will be analyzed.|Change from Baseline to Week 28 in health status by EQ-5D-5L score.|Change from Baseline to Week 28 in EQ-VAS score.|Change from Baseline in SBP, DBP and MAP at Week 28 will be analyzed.|Percentage of participants with at least one BP exacerbation during the study will be analyzed.|Other Pre-specified Outcome Measures:|Includes AEs of special interest and adjudicated Major adverse cardiovascular event (MACE) (composite of all-cause mortality, non-fatal Myocardial infarction","Baseline and up to Week 28|Baseline and Week 28|Up to Week 28|Baseline and at Week 28|MI and non-fatal stroke).",{"$nulls":3},"Ciudad Autonoma De Buenos Aires, Buenos Aires, Argentina, C1128Aaf Gsk Investigational SiteCiudad Autonoma De Buenos Aires, Buenos Aires, Argentina, C1425Agc Gsk Investigational SiteMar Del Plata, Buenos Aires, Argentina, 7600 Gsk Investigational SiteMar Del Plata, Buenos Aires, Argentina, B7600Fzn Gsk Investigational SiteSan Nicolas, Buenos Aires, Argentina, B2900Dmh|Cordoba, CÃ³rdova, Argentina, 5003|Santa Fe, Argentina, 3000|Rosario, Santa Fe, Argentina, S2000Dej|Fitzroy, Australia, 3065|Murdoch, Western|Sydney, New South Wales, Australia, 2010|Heidelberg, Victoria, Australia, 3084 Gsk Investigational SiteParkville, Victoria, Australia, 3050|Feira De Santana., Bahia, Brazil, 44001-584 Gsk Investigational SiteSalvador, Bahia, Brazil, 40415-065|Vitoria, EspÃ­rito Santo, Brazil, 29055450|SÃ£o Paulo, Brazil, 04038002|RibeirÃ£o Preto, SÃ£o Paulo, Brazil, 14025170 Gsk Investigational SiteSanto AndrÃ© - Sp, SÃ£o Paulo, Brazil, 09080-110 Gsk Investigational SiteSao Jose Do Rio Preto, SÃ£o Paulo, Brazil, 15015200 Gsk Investigational SiteSao Jose Do Rio Preto, SÃ£o Paulo, Brazil, 15090-000 Gsk Investigational SiteSÃ£o Bernardo Do Campo, SÃ£o Paulo, Brazil, 09715090|Victoria, British Columbia, Canada, V8V 4A1|Quebec, Canada, G3K 2P8|Brampton, Ontario, Canada, L6T 0G1 Gsk Investigational SiteGuelph, Ontario, Canada, N1H 1B1 Gsk Investigational SiteKitchener, Ontario, Canada, N2H 5Z8 Gsk Investigational SiteOttawa, Ontario, Canada, K1H 1A2 Gsk Investigational SiteSarnia, Ontario, Canada, N7T 4X3 Gsk Investigational SiteSudbury, Ontario, Canada Gsk Investigational SiteToronto, Ontario, Canada, M5B 1W8 Gsk Investigational SiteToronto, Ontario, Canada, M9N 1N8 Gsk Investigational SiteToronto, Ontario, Canada, M9V 4B4|MontrÃ©al, Quebec, Canada, H1M 1B1 Gsk Investigational SiteQuebec City, Quebec, Canada, G2J 0C4 Gsk Investigational SiteSt-Charles-BorromÃ©e, Quebec, Canada, J6E 2B4|Grenoble Cedex 9, France, 38043 Gsk Investigational SiteLe Mans Cedex 9, France, 72037 Gsk Investigational SiteMarseille Cedex 5, France, 13385 Gsk Investigational SiteMelun, France, 77000 Gsk Investigational SiteMulhouse Cedex, France, 68070 Gsk Investigational SiteNantes Cedex 1, France, 44093 Gsk Investigational SiteNice Cedex 1, France, 06001 Gsk Investigational SiteSaint-Priest En Jarez, France, 42270|Catanzaro, Calabria, Italy, 88100|Napoli, Campania, Italy, 80131|Bologna, Emilia-Romagna, Italy, 40138 Gsk Investigational SiteModena, Emilia-Romagna, Italy, 41124|Genova, Liguria, Italy, 16132|Pavia, Lombardia, Italy, 27100|Mestre, Veneto, Italy, 30174 Korea, Republic Of Gsk Investigational SiteBusan, Korea, Republic Of, 49201 Gsk Investigational SiteBusan, Korea, Republic Of, 49241 Gsk Investigational SiteDaegu-Si, Korea, Republic Of, 42601 Gsk Investigational SiteDaegu, Korea, Republic Of, 42415 Gsk Investigational SiteGyeonggi-Do, Korea, Republic Of, 463-712 Gsk Investigational SiteSeongnam-Si, Gyeonggi-Do, Korea, Republic Of, 13620 Gsk Investigational SiteSeoul, Korea, Republic Of, 03312 Gsk Investigational SiteSeoul, Korea, Republic Of, 08308|Guadalajara, Mexico, 44600 Gsk Investigational SiteMerida, Mexico, 97000 Gsk Investigational SiteVeracruz, Mexico, 91900|Leon, Guanajuato, Mexico, 37390|Guadalajara, Jalisco, Mexico, 44150|Monterrey, Nuevo LeÃ³n, Mexico, 64060|Boca Del Rio, Veracruz, Mexico, 24290 Gsk Investigational SiteCÃ³rdoba, Veracruz, Mexico, 94550|Merida, YucatÃ¡n, Mexico, 97070|Bialystok, Poland, 15-276 Gsk Investigational SiteCiechanow, Poland, 06-400 Gsk Investigational SiteKrakow, Poland, 30510 Gsk Investigational SiteKrakow, Poland, 31-513 Gsk Investigational SiteKrakow, Poland, 31-559 Gsk Investigational SiteLodz, Poland, 92-213 Gsk Investigational SiteLublin, Poland, 20-068 Gsk Investigational SiteOlawa, Poland, 55-200 Gsk Investigational SitePleszew, Poland, 63-300 Gsk Investigational SiteSosnowiec, Poland, 41-200 Gsk Investigational SiteSwidnik, Poland, 21-040 Gsk Investigational SiteSzczecin, Poland, 70-111 Gsk Investigational SiteTczew, Poland, 83-110 Gsk Investigational SiteWarszawa, Poland, 01-868 Gsk Investigational SiteWarszawa, Poland, 02-801 Gsk Investigational SiteWarszawa, Poland, 04-749|Brasov, Romania, 500283 Gsk Investigational SiteBucharest, Romania, 022328 Gsk Investigational SiteBucharest, Romania, 022328 Gsk Investigational SiteBucharest, Romania, 042122 Gsk Investigational SiteCluj-Napoca, Romania, 400139 Gsk Investigational SiteCraiova, Romania, 200642 Gsk Investigational SiteDeva, Romania, 330084 Gsk Investigational SiteOradea, Romania, 410469 Gsk Investigational SiteTargu Mures, Romania, 540096 Gsk Investigational SiteTimisoara, Romania, 300723 Russian Federation Gsk Investigational SiteIzhevsk, Russian Federation, 426061 Gsk Investigational SiteKaliningrad, Russian Federation, 236016 Gsk Investigational SiteKemerovo, Russian Federation, 650066 Gsk Investigational SiteKrasnoyarsk, Russian Federation, 660022 Gsk Investigational SiteMoscow, Russian Federation, 121359 Gsk Investigational SiteNizhniy Novgorod, Russian Federation, 603126 Gsk Investigational SitePyatigorsk, Russian Federation, 357500 Gsk Investigational SitePyatigorsk, Russian Federation, 357538 Gsk Investigational SiteRostov-On-Don, Russian Federation, 344022 Gsk Investigational SiteRyazan, Russian Federation, 390037 Gsk Investigational SiteSaint Petersburg, Russian Federation, 194355 Gsk Investigational SiteSaint Petersburg, Russian Federation, 197022 Gsk Investigational SiteStavropol, Russian Federation, 355017 Gsk Investigational SiteYaroslavl, Russian Federation, 150000 Gsk Investigational SiteYaroslavl, Russian Federation, 150030 Gsk Investigational SiteYaroslavl, Russian Federation, 150062|Badalona, Spain, 08916 Gsk Investigational SiteMadrid, Spain, 28040 Gsk Investigational SiteSantiago De Compostela, Spain|Canterbury, Kent, United Kingdom, Ct1 3Ng|Derby, United Kingdom, De22 3Ne Gsk Investigational SiteLondon, United Kingdom, Se5 9Rs Gsk Investigational SitePeterborough, United Kingdom, Pe3 9Gz Gsk Investigational SitePlymouth, United Kingdom, Pl6 8Dh Gsk Investigational SiteShrewsbury, United Kingdom, Sy3 8Xq Gsk Investigational SiteSwansea, United Kingdom, Sa6 6Nl|Homewood, Alabama, United States, 35209|Little Rock, Arkansas, United States, 72204|Downey, California, United States, 90242 Gsk Investigational SiteFresno, California, United States, 93720 Gsk Investigational SiteLynwood, California, United States, 90262 Gsk Investigational SiteNorthridge, California, United States, 91324 Gsk Investigational SiteNorthridge, California, United States, 91325 Gsk Investigational SiteRiverside, California, United States, 82503 Gsk Investigational SiteSalinas, California, United States, 93901 Gsk Investigational SiteSanta Ana, California, United States, 92704|Denver, Colorado, United States, 80230|Hartford, Connecticut, United States, 06112 Gsk Investigational SiteMiddlebury, Connecticut, United States, 06762|Coral Springs, Florida, United States, 33067 Gsk Investigational SiteHollywood, Florida, United States, 33021-5424 Gsk Investigational SiteHollywood, Florida, United States, 33024 Gsk Investigational SiteKissimmee, Florida, United States, 34741 Gsk Investigational SiteLauderdale Lakes, Florida, United States, 33313 Gsk Investigational SiteTampa, Florida, United States, 33614|Adairsville, Georgia, United States, 30103 Gsk Investigational SiteMacon, Georgia, United States, 31201 Gsk Investigational SiteMacon, Georgia, United States, 31217 Gsk Investigational SiteStatesboro, Georgia, United States, 30458|Indianapolis, Indiana, United States, 46260|Overland Park, Kansas, United States, 66210|Buckley, Michigan, United States, 49620 Gsk Investigational SiteDetroit, Michigan, United States, 48202 Gsk Investigational SiteSaint Clair Shores, Michigan, United States, 48081|Brookhaven, Mississippi, United States, 39601|Saint Louis, Missouri, United States, 63136|Portsmouth, New Hampshire, United States, 03801|Asheville, North Carolina, United States, 28801 Gsk Investigational SiteCharlotte, North Carolina, United States, 28262 Gsk Investigational SiteDurham, North Carolina, United States, 27704|Midwest City, Oklahoma, United States, 73130 Gsk Investigational SiteOklahoma City, Oklahoma, United States, 73112|Beaver, Pennsylvania, United States, 15009 Gsk Investigational SiteDuncansville, Pennsylvania, United States, 16635 Gsk Investigational SiteScottdale, Pennsylvania, United States, 15683 Gsk Investigational SiteSmithfield, Pennsylvania, United States, 15478 Gsk Investigational SiteWest Reading, Pennsylvania, United States, 19611|Orangeburg, South Carolina, United States, 29118|Kingsport, Tennessee, United States, 37660 Gsk Investigational SiteMemphis, Tennessee, United States, 38163|Desoto, Texas, United States, 75115 Gsk Investigational SiteEl Paso, Texas, United States, 79935 Gsk Investigational SiteMcallen, Texas, United States, 78503 Gsk Investigational SiteWaxahachie, Texas, United States, 75165|Norfolk, Virginia, United States, 23502","Alabama|Arkansas|California|Colorado|Connecticut|Florida|Georgia|Indiana|Kansas|Michigan|Mississippi|Missouri|New Hampshire|North Carolina|Oklahoma|Pennsylvania|South Carolina|Tennessee|Texas|Virginia","Argentina|Australia|Brazil|Canada|France|Italy|Mexico|Poland|Romania|Spain|United Kingdom|United States","Buenos Aires Gsk Investigational Site|CÃ³rdova Gsk Investigational Site|Gsk Investigational Site|Santa Fe Gsk Investigational Site|New South Wales Gsk Investigational Site|Victoria Gsk Investigational Site|Bahia Gsk Investigational Site|EspÃ­rito Santo Gsk Investigational Site|SÃ£o Paulo Gsk Investigational Site|British Columbia Gsk Investigational Site|Ontario Gsk Investigational Site|Quebec Gsk Investigational Site|Calabria Gsk Investigational Site|Campania Gsk Investigational Site|Emilia-Romagna Gsk Investigational Site|Liguria Gsk Investigational Site|Lombardia Gsk Investigational Site|Veneto Gsk Investigational Site|Guanajuato Gsk Investigational Site|Jalisco Gsk Investigational Site|Nuevo LeÃ³n Gsk Investigational Site|Veracruz Gsk Investigational Site|YucatÃ¡n Gsk Investigational Site|, Kent Gsk Investigational Site",{"$nulls":3},"GSK Clinical Trials","2020-04-21","2020-05-25T16:38:30.303","2020-05-26T17:10:42.972","NCT03409107"]
["5ecbf488fe30261b1a048334","NCT03409679","2018-01-24","Polyphor","PPHOF","Not yet recruiting","Pivotal Study in VAP Suspected or Confirmed to be Due to Pseudomonas Aeruginosa","Murepavadin",null,"Yes","['Murepavadin']","Unknown",null,"Phase 3",2,150,"Anticipated","2018-03-01","2020-05-01",{"$nulls":5},"This is a phase 3, multicenter, open-label, randomized active-controlled, parallel group to investigate the efficacy, safety and tolerability, and pharmacokinetics of intravenous murepavadin combined with of one anti-pseudononas antibiotic with that of two anti-pseudomonas antibiotics in the treatment of ventilator-associated bacterial pneumonia (VABP) in adult subjects.",null,"A Multicenter, Open-label, Randomized, Active-controlled, Parallel Group, Pivotal Study to Investigate the Efficacy, Safety and Tolerability, and Pharmacokinetics of Murepavadin Combined With One Anti-pseudomonal Antibiotic Versus Two Anti-pseudomonal Antibiotics in Adult Subjects With Ventilator-associated Bacterial Pneumonia Suspected or Confirmed to be Due to Pseudomonas Aeruginosa","POL7080-011","Pneumonia","Pneumonia","Lung Diseases","Respiratory","Experimental|Active Comparator","Murepavadin|Two anti-pseudomonal antibiotics","Murepavadin IV + one anti-pseudomonal antibiotic|Association of 2 anti-pseudomonal antibiotics","Drug","Murepavadin|Two anti-pseudomonal antibiotics","Murepavadin IV every 8 hours + 1 anti-pseudomonal antibiotic (Piperacillin-tazobactam, ceftazidine, cefepime, meropenem, amikacin, ciprofoxacin, levofloxacin, colistin)|Piperacillin-tazobactam, ceftazidine, cefepime, meropenem, amikacin, ciprofoxacin, levofloxacin, colistin",null,"Murepavadin|Two anti-pseudomonal antibiotics","\n\n * Subject has received mechanical ventilation for at least 48h at the time of the randomisation\n * Acute Physiology and Chronic Health Evaluation (APACHE) of 8 to 30, inclusive, within 24h prior to randomization\n * Presence of new or progressive infiltrate on chest X-ray\n * Presence of clinical criteria consistent with VABP\n * High probability of VABP caused by Pseudomonas aeriginosa\n\nKey ","\n\n * Known or suspected community-acquired bacterial pneumonia or viral, fungal, or parasitic pneumonia\n * Known hypersensitivity or contra-indications to beta-lactam antibiotics, aminoglycosides, quinolones, colistin, or subjects with a clinically significant history of anaphylactic reaction\n * Severe liver or renal impairment\n * Women who are pregnant or nursing, or who are of chilbearing potential and unwilling to use acceptable method of birth control",{"$nulls":4},"Actual","2018-01-24","Actual","Anticipated","2020-07-01","Anticipated","2018-01-01","2018-01-08","2018-01-17","2018-01-17",null,null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":19},"Clinical cure rate","21-24 days after start of study treatment",{"$nulls":5},"Polyphor",{"$nulls":9},"2018-01-17","2020-05-25T16:38:32.099","2020-05-26T17:10:42.972","NCT03409679"]
["5ecbf488e2561b1b11905e2e","NCT03409679","2018-04-02","Polyphor","PPHOF","Recruiting","Pivotal Study in VAP Suspected or Confirmed to be Due to Pseudomonas Aeruginosa (PRISM-MDR)","Murepavadin",null,"Yes","['Murepavadin']","Unknown",null,"Phase 3",2,150,"Anticipated","2018-03-23","2020-05-01",{"$nulls":5},"This is a phase 3, multicenter, open-label, randomized active-controlled, parallel group to investigate the efficacy, safety and tolerability, and pharmacokinetics of intravenous murepavadin combined with of one anti-pseudononas antibiotic with that of two anti-pseudomonas antibiotics in the treatment of ventilator-associated bacterial pneumonia (VABP) in adult subjects.",null,"A Multicenter, Open-label, Randomized, Active-controlled, Parallel Group, Pivotal Study to Investigate the Efficacy, Safety and Tolerability, and Pharmacokinetics of Murepavadin Combined With One Anti-pseudomonal Antibiotic Versus Two Anti-pseudomonal Antibiotics in Adult Subjects With Ventilator-associated Bacterial Pneumonia Suspected or Confirmed to be Due to Pseudomonas Aeruginosa","POL7080-011","Pneumonia","Pneumonia","Lung Diseases","Respiratory","Experimental|Active Comparator","Murepavadin|Two anti-pseudomonal antibiotics","Murepavadin IV + one anti-pseudomonal antibiotic|Association of 2 anti-pseudomonal antibiotics","Drug","Murepavadin|Two anti-pseudomonal antibiotics","Murepavadin IV every 8 hours + 1 anti-pseudomonal antibiotic (Piperacillin-tazobactam, ceftazidine, cefepime, meropenem, amikacin, ciprofoxacin, levofloxacin, colistin)|Piperacillin-tazobactam, ceftazidine, cefepime, meropenem, amikacin, ciprofoxacin, levofloxacin, colistin",null,"Murepavadin|Two anti-pseudomonal antibiotics","\n\n * Subject has received mechanical ventilation for at least 48h at the time of the randomisation\n * Acute Physiology and Chronic Health Evaluation (APACHE) of 8 to 30, inclusive, within 24h prior to randomization\n * Presence of new or progressive infiltrate on chest X-ray\n * Presence of clinical criteria consistent with VABP\n * High probability of VABP caused by Pseudomonas aeriginosa\n\nKey ","\n\n * Known or suspected community-acquired bacterial pneumonia or viral, fungal, or parasitic pneumonia\n * Known hypersensitivity or contra-indications to beta-lactam antibiotics, aminoglycosides, quinolones, colistin, or subjects with a clinically significant history of anaphylactic reaction\n * Severe liver or renal impairment\n * Women who are pregnant or nursing, or who are of chilbearing potential and unwilling to use acceptable method of birth control",{"$nulls":4},"Actual","2018-01-24","Actual","Anticipated","2020-07-01","Anticipated","2018-03-01","2018-01-08","2018-01-17","2018-03-29",null,null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":19},"Clinical cure rate","21-24 days after start of study treatment",{"$nulls":4},"info@polyphor.com","Polyphor Ltd",41615671600,"Tartu, Estonia South Estonian Hospital LtdVÃµru, Estonia|Limoges, France Chu De Nice - L'ArchetNice, France|Nahariya, Israel Ziv Medical CenterZefat, Israel",null,"Estonia|France|Israel","Tartu University Hospital|Chu Limoges|Galilee Medical Center",{"$nulls":4},"2018-03-29","2020-05-25T16:38:32.202","2020-05-26T17:10:42.972","NCT03409679"]
["5ecbf488feab101b15530963","NCT03409679","2019-08-28","Polyphor","PPHOF","Terminated","Pivotal Study in VAP Suspected or Confirmed to be Due to Pseudomonas Aeruginosa (PRISM-MDR)","Murepavadin",null,"Yes","['Murepavadin']","Unknown",null,"Phase 3",2,41,"Actual","2018-03-23","2019-07-17",{"$nulls":5},"This is a phase 3, multicenter, open-label, randomized active-controlled, parallel group to investigate the efficacy, safety and tolerability, and pharmacokinetics of intravenous murepavadin combined with of one anti-pseudononas antibiotic with that of two anti-pseudomonas antibiotics in the treatment of ventilator-associated bacterial pneumonia (VABP) in adult subjects.",null,"A Multicenter, Open-label, Randomized, Active-controlled, Parallel Group, Pivotal Study to Investigate the Efficacy, Safety and Tolerability, and Pharmacokinetics of Murepavadin Combined With One Anti-pseudomonal Antibiotic Versus Two Anti-pseudomonal Antibiotics in Adult Subjects With Ventilator-associated Bacterial Pneumonia Suspected or Confirmed to be Due to Pseudomonas Aeruginosa","POL7080-011","Pneumonia","Pneumonia","Lung Diseases","Respiratory","Experimental|Active Comparator","Murepavadin|Two anti-pseudomonal antibiotics","Murepavadin IV + one anti-pseudomonal antibiotic|Association of 2 anti-pseudomonal antibiotics","Drug","Murepavadin|Two anti-pseudomonal antibiotics","Murepavadin IV every 8 hours + 1 anti-pseudomonal antibiotic (Piperacillin-tazobactam, ceftazidine, cefepime, meropenem, amikacin, ciprofoxacin, levofloxacin, colistin)|Piperacillin-tazobactam, ceftazidine, cefepime, meropenem, amikacin, ciprofoxacin, levofloxacin, colistin",null,"Murepavadin|Two anti-pseudomonal antibiotics","\n\n * Subject has received mechanical ventilation for at least 48h at the time of the randomisation\n * Acute Physiology and Chronic Health Evaluation (APACHE) of 8 to 30, inclusive, within 24h prior to randomization\n * Presence of new or progressive infiltrate on chest X-ray\n * Presence of clinical criteria consistent with VABP\n * High probability of VABP caused by Pseudomonas aeriginosa\n\nKey ","\n\n * Known or suspected community-acquired bacterial pneumonia or viral, fungal, or parasitic pneumonia\n * Known hypersensitivity or contra-indications to beta-lactam antibiotics, aminoglycosides, quinolones, colistin, or subjects with a clinically significant history of anaphylactic reaction\n * Severe liver or renal impairment\n * Women who are pregnant or nursing, or who are of chilbearing potential and unwilling to use acceptable method of birth control",{"$nulls":4},"Actual","2018-01-24","Actual","Actual","2019-07-17","Actual","2019-05-01","2018-01-08","2018-01-17","2019-08-23",null,null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":19},"Clinical cure rate","21-24 days after start of study treatment",{"$nulls":7},"Belo Horizonte, Brazil Research Site 2Belo Horizonte, Brazil Research SiteItaquaquecetuba, Brazil Research SitePorto Alegre, Brazil Research SiteSÃ£o JosÃ© Do Rio Preto, Brazil|Zagreb, Croatia Research Site 2Zagreb, Croatia|Tallinn, Estonia Reasearch SiteTartu, Estonia Reasearch SiteVÃµru, Estonia|Lille, France Reasearch SiteLimoges, France Research SiteLyon, France Reasearch SiteNice, France Research Site 1Paris, France Research Site 2Paris, France Research Site 3Paris, France Research SitePierre-BÃ©nite, France|Athens, Greece Research SiteIoÃ¡nnina, Greece Research Site 1Larissa, Greece Research Site 2Larissa, Greece Research SitePatra, Greece Research SiteThessalonÃ­ki, Greece|Budapest, Bu, Hungary Research SiteBudapest, Bu, Hungary|Ã“zd, Bz, Hungary|Kistarcsa, Hungary Research SiteSzekesfehervar, Hungary Research SiteVÃ¡c, Hungary|Jerusalem, Jm, Israel|Petah Tiqva, Israel Research SiteTel Hashomer, Israel Research SiteZefat, Israel Korea, Republic Of Research SiteAnsansi Danweongu, Korea, Republic Of Research SiteGangwon-Do, Korea, Republic Of Research SiteGyeongsang, Korea, Republic Of Research SiteIncheon, Korea, Republic Of Research Site 1Seoul, Korea, Republic Of Research Site 2Seoul, Korea, Republic Of Research Site 3Seoul, Korea, Republic Of Research SiteSeoul, Korea, Republic Of|Nahariya, Z, Israel Research SiteTiberias, Z, Israel|Guadalajara, Mexico Research Site 2Guadalajara, Mexico Research SiteMonterrey, Mexico|Tshwane, Gauteng, South Africa|Cape Town, South Africa Research SitePretoria, South Africa Research Site 2Tshwane, South Africa|Barcelona, B, Spain Research SiteTerrassa, B, Spain|Girona, Spain|Bangkok, Thailand Research Site 2Bangkok, Thailand Research SiteKhon Kaen, Thailand Research SiteNonthaburi, Thailand|Chicago, Illinois, United States, 60208|Springfield, Missouri, United States, 65802|Greensboro, North Carolina, United States, 27403","Illinois|Missouri|North Carolina","Brazil|Croatia|Estonia|France|Greece|Hungary|Israel|Mexico|South Africa|Spain|Thailand|United States","Research Site 1|Research Site|Bu Reasearch Site|Bz Reasearch Site|Jm Research Site|Z Research Site|, Gauteng Research Site 1|B Research Site",{"$nulls":4},"2019-08-23","2020-05-25T16:38:32.482","2020-05-26T17:10:42.972","NCT03409679"]
["5ecbf48911702c1b1b916b45","NCT03409744","2018-03-13","Regeneron","REGN","Enrolling by invitation","Evaluate the Long-Term Safety and Efficacy of Evinacumab in Patients With Homozygous Familial Hypercholesterolemia","Evinacumab",null,"Yes","['Evinacumab']","Unknown",null,"Phase 3",1,66,"Anticipated","2018-03-16","2022-10-06",{"$nulls":5},"The primary objective of the study is to evaluate the long-term safety and tolerability of evinacumab in patients with Homozygous Familial Hypercholesterolemia (HoFH). The secondary objectives of the study are to evaluate the effect of evinacumab on lipid parameters in patients with HoFH and to evaluate the potential development of anti-evinacumab antibodies.",null,"An Open-Label Study to Evaluate the Long-Term Safety and Efficacy of Evinacumab in Patients With Homozygous Familial Hypercholesterolemia","R1500-CL-1719","Homozygous Familial Hypercholesterolemia","Hypercholesterolemia","Metabolic Diseases","Nutritional Disorders","Experimental","evinacumab",null,"Drug","evinacumab","Intravenous (IV) administration","REGN1500","evinacumab","\n\n 1. Completion of the parent study in which they participated\n 2. Able to understand and complete study-related questionnaires\n\nKey ","\n\n 1. Significant protocol deviation in the parent study based on the investigator's judgment, such as non-compliance by the patient\n 2. Concomitant medications that have not been stable prior to the baseline visit\n 3. Adverse event leading to permanent discontinuation from parent study\n 4. Any new condition or worsening of an existing condition, which in the opinion of the investigator would make the patient unsuitable for enrollment, or could interfere with the patient participating in or completing the study\n 5. Member of the clinical site study team and/or his/her immediate family\n 6. Pregnant or breastfeeding women\n 7. Women of childbearing potential who are unwilling to practice highly effective contraception prior to the initial dose/start of the first treatment, during the study, and for at least 24 weeks after the last dose of study drug\n 8. Sexually active men who are unwilling to use forms of medically acceptable birth control during the study drug treatment period and for 24 weeks after the last injection of study drug\n\nNote: Other protocol defined Inclusion/Exclusion criteria may apply.",{"$nulls":4},"Actual","2018-01-24","Actual","Anticipated","2022-10-06","Anticipated","2018-03-01","2018-01-08","2018-01-17","2018-03-12","Yes","HoFH","Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"2017-003170-13","EudraCT Number","Incidence and severity of treatment-emergent adverse events (TEAEs)","Up to 192 weeks",null,"Percent change in Low-Density Lipoprotein Cholesterol (LDL-C) over time|Absolute change in LDL-C over time|Percent change in Apolipoprotein B (Apo B) over time|Absolute change in Apo B over time|Percent change in non-High-Density Lipoprotein Cholesterol (HDL-C) over time|Absolute change in non-HDL-C over time|Percent change in Total Cholesterol (TC) over time|Absolute change in TC over time|Percent change in Triglycerides (TGs) over time|Absolute change in TGs over time|Presence of anti-evinacumab antibodies","Up to 192 weeks",{"$nulls":4},"Chicoutimi, Quebec, Canada, G7H 7K9",null,"Canada","Quebec Clinical Trial Site",{"$nulls":3},"Clinical Trial Management","2018-03-12","2020-05-25T16:38:33.683","2020-05-26T17:10:42.972","NCT03409744"]
["5ecbf489fe30261b1a048338","NCT03409744","2018-05-11","Regeneron","REGN","Enrolling by invitation","Evaluate the Long-Term Safety and Efficacy of Evinacumab in Patients With Homozygous Familial Hypercholesterolemia","Evinacumab",null,"Yes","['Evinacumab']","Unknown",null,"Phase 3",1,66,"Anticipated","2018-03-13","2022-04-01",{"$nulls":5},"The primary objective of the study is to evaluate the long-term safety and tolerability of evinacumab in patients with Homozygous Familial Hypercholesterolemia (HoFH). The secondary objectives of the study are to evaluate the effect of evinacumab on lipid parameters in patients with HoFH and to evaluate the potential development of anti-evinacumab antibodies.",null,"An Open-Label Study to Evaluate the Long-Term Safety and Efficacy of Evinacumab in Patients With Homozygous Familial Hypercholesterolemia","R1500-CL-1719","Homozygous Familial Hypercholesterolemia","Hypercholesterolemia","Metabolic Diseases","Nutritional Disorders","Experimental","evinacumab",null,"Drug","evinacumab","Intravenous (IV) administration","REGN1500","evinacumab","\n\n 1. Completion of the parent study in which they participated\n 2. Able to understand and complete study-related questionnaires\n\nKey ","\n\n 1. Significant protocol deviation in the parent study based on the investigator's judgment, such as non-compliance by the patient\n 2. Concomitant medications that have not been stable prior to the baseline visit\n 3. Adverse event leading to permanent discontinuation from parent study\n 4. Any new condition or worsening of an existing condition, which in the opinion of the investigator would make the patient unsuitable for enrollment, or could interfere with the patient participating in or completing the study\n 5. Member of the clinical site study team and/or his/her immediate family\n 6. Pregnant or breastfeeding women\n 7. Women of childbearing potential who are unwilling to practice highly effective contraception prior to the initial dose/start of the first treatment, during the study, and for at least 24 weeks after the last dose of study drug\n 8. Sexually active men who are unwilling to use forms of medically acceptable birth control during the study drug treatment period and for 24 weeks after the last injection of study drug\n\nNote: Other protocol defined Inclusion/Exclusion criteria may apply.",{"$nulls":4},"Actual","2018-01-24","Actual","Anticipated","2022-04-01","Anticipated","2018-05-01","2018-01-08","2018-01-17","2018-05-09","Yes","HoFH","Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"2017-003170-13","EudraCT Number","Incidence and severity of treatment-emergent adverse events (TEAEs)","Up to 192 weeks",null,"Percent change in Low-Density Lipoprotein Cholesterol (LDL-C) over time|Absolute change in LDL-C over time|Percent change in Apolipoprotein B (Apo B) over time|Absolute change in Apo B over time|Percent change in non-High-Density Lipoprotein Cholesterol (HDL-C) over time|Absolute change in non-HDL-C over time|Percent change in Total Cholesterol (TC) over time|Absolute change in TC over time|Percent change in Triglycerides (TGs) over time|Absolute change in TGs over time|Presence of anti-evinacumab antibodies","Up to 192 weeks",{"$nulls":4},"Chicoutimi, Quebec, Canada, G7H 7K9|Amsterdam, Netherlands, 1105 Az|Philadelphia, Pennsylvania, United States, 19104|Dallas, Texas, United States, 75390","Pennsylvania|Texas","Canada|Netherlands|United States","Quebec Clinical Trial Site|Clinical Trial Site",{"$nulls":3},"Clinical Trial Management","2018-05-09","2020-05-25T16:38:33.806","2020-05-26T17:10:42.972","NCT03409744"]
["5ecbf48a11702c1b1b916b46","NCT03409744","2019-08-14","Regeneron","REGN","Enrolling by invitation","Evaluate the Long-Term Safety and Efficacy of Evinacumab in Patients With Homozygous Familial Hypercholesterolemia","Evinacumab",null,"Yes","['Evinacumab']","Unknown",null,"Phase 3",1,100,"Anticipated","2018-03-13","2022-04-11",{"$nulls":5},"The primary objective of the study is to evaluate the long-term safety and tolerability of evinacumab in patients with Homozygous Familial Hypercholesterolemia (HoFH). The secondary objectives of the study are to evaluate the effect of evinacumab on lipid parameters in patients with HoFH and to evaluate the potential development of anti-evinacumab antibodies.",null,"An Open-Label Study to Evaluate the Long-Term Safety and Efficacy of Evinacumab in Patients With Homozygous Familial Hypercholesterolemia","R1500-CL-1719","Homozygous Familial Hypercholesterolemia","Hypercholesterolemia","Metabolic Diseases","Nutritional Disorders","Experimental","evinacumab",null,"Drug","evinacumab","Intravenous (IV) administration","REGN1500","evinacumab","\n\n 1. Completion of the parent study in which they participated\n 2. Able to understand and complete study-related questionnaires\n\nKey ","\n\n 1. Significant protocol deviation in the parent study based on the investigator's judgment, such as non-compliance by the patient\n 2. Concomitant medications that have not been stable prior to the baseline visit\n 3. Adverse event leading to permanent discontinuation from parent study\n 4. Any new condition or worsening of an existing condition, which in the opinion of the investigator would make the patient unsuitable for enrollment, or could interfere with the patient participating in or completing the study\n 5. Member of the clinical site study team and/or his/her immediate family\n 6. Pregnant or breastfeeding women\n 7. Women of childbearing potential who are unwilling to practice highly effective contraception prior to the initial dose/start of the first treatment, during the study, and for at least 24 weeks after the last dose of study drug\n 8. Sexually active men who are unwilling to use forms of medically acceptable birth control during the study drug treatment period and for 24 weeks after the last injection of study drug\n\nNote: Other protocol defined Inclusion/Exclusion criteria may apply.",{"$nulls":4},"Actual","2018-01-24","Actual","Anticipated","2022-04-11","Anticipated","2019-08-01","2018-01-08","2018-01-17","2019-08-12","Yes","HoFH","Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","12 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"2017-003170-13","EudraCT Number","Incidence and severity of treatment-emergent adverse events (TEAEs)","Up to 192 weeks",null,"Percent change in Low-Density Lipoprotein Cholesterol (LDL-C) over time|Absolute change in LDL-C over time|Percent change in Apolipoprotein B (Apo B) over time|Absolute change in Apo B over time|Percent change in non-High-Density Lipoprotein Cholesterol (HDL-C) over time|Absolute change in non-HDL-C over time|Percent change in Total Cholesterol (TC) over time|Absolute change in TC over time|Percent change in Triglycerides (TGs) over time|Absolute change in TGs over time|Presence of anti-evinacumab antibodies","Up to 192 weeks",{"$nulls":4},"Perth, Western|Camperdown, New South Wales, Australia, 2050|Quebec, Canada, G1V 4W2|Chicoutimi, Quebec, Canada, G7H 7K9|Paris, Cedex 13, France, 75651|Marseille, Cedex 5, France, 13385|Dijon, Cedex, France, 21079|Ioannina, Greece, 45500|Napoli, Campania, Italy, 80131|Roma, Rome, Italy, 161|Amsterdam, Netherlands, 1105 Az|Oslo, Norway, 0586|Ivano-Frankivsk, Ukraine, 76075 Clinical Trial Site #1Kharkiv, Ukraine, 61039 Clinical Trial Site #2Kharkiv, Ukraine, 61039 Clinical Trial SiteKyiv, Ukraine, 02660|Los Angeles, California, United States, 90048|Boca Raton, Florida, United States, 33434|Boston, Massachusetts, United States, 02114|New York, New York, United States, 10029|Cincinnati, Ohio, United States, 45227|Portland, Oregon, United States, 97239|Philadelphia, Pennsylvania, United States, 19104|Dallas, Texas, United States, 75226 Clinical Trial SiteDallas, Texas, United States, 75390","California|Florida|Massachusetts|New York|Ohio|Oregon|Pennsylvania|Texas","Australia|Canada|France|Greece|Italy|Netherlands|Norway|Ukraine|United States","Clinical Trial Site|New South Wales Clinical Trial Site|Quebec Clinical Trial Site|Cedex 13 Clinical Trial Site|Cedex 5 Clinical Trial Site|Cedex Clinical Trial Site|Campania Clinical Trial Site|Rome Clinical Trial Site",{"$nulls":3},"Clinical Trial Management","2019-08-12","2020-05-25T16:38:34.134","2020-05-26T17:10:42.972","NCT03409744"]
["5ecbf48ae2561b1b11905e33","NCT03409744","2020-05-13","Regeneron","REGN","Enrolling by invitation","Evaluate the Long-Term Safety and Efficacy of Evinacumab in Patients With Homozygous Familial Hypercholesterolemia","Evinacumab",null,"Yes","['Evinacumab']","Unknown",null,"Phase 3",1,120,"Anticipated","2018-03-13","2022-04-18",{"$nulls":5},"The primary objectives of the study are:\n\n * To evaluate the long-term safety and tolerability of evinacumab in patients with Homozygous Familial Hypercholesterolemia (HoFH)\n * To evaluate the long-term safety and tolerability of evinacumab in adolescent patients with HoFH\n\nThe secondary objectives of the study are:\n\n * To evaluate the effect of evinacumab on lipid parameters in patients with HoFH\n * To evaluabe the effect of evinacumab on lipd parameters in adolescent patients with HoFH\n * To evaluate the potential development of anti-evinacumab antibodies",null,"An Open-Label Study to Evaluate the Long-Term Safety and Efficacy of Evinacumab in Patients With Homozygous Familial Hypercholesterolemia","R1500-CL-1719","Homozygous Familial Hypercholesterolemia","Hypercholesterolemia","Metabolic Diseases","Nutritional Disorders","Experimental","evinacumab",null,"Drug","evinacumab","Intravenous (IV) administration","REGN1500","evinacumab","\n\n 1. Completion of the parent study in which they participated\n 2. Able to understand and complete study-related questionnaires\n\nKey ","\n\n 1. Significant protocol deviation in the parent study based on the investigator's judgment, such as non-compliance by the patient\n 2. Concomitant medications that have not been stable prior to the baseline visit\n 3. Adverse event leading to permanent discontinuation from parent study\n 4. Any new condition or worsening of an existing condition, which in the opinion of the investigator would make the patient unsuitable for enrollment, or could interfere with the patient participating in or completing the study\n 5. Member of the clinical site study team and/or his/her immediate family\n 6. Pregnant or breastfeeding women\n 7. Women of childbearing potential who are unwilling to practice highly effective contraception prior to the initial dose/start of the first treatment, during the study, and for at least 24 weeks after the last dose of study drug\n 8. Men who are sexually active with women of childbearing potential and are unwilling to use condoms during the study drug treatment period and for 24 weeks after the last injection of study drug regardless of vasectomy status\n\nNote: Other protocol defined Inclusion/Exclusion criteria apply",{"$nulls":4},"Actual","2018-01-24","Actual","Anticipated","2022-04-18","Anticipated","2020-05-01","2018-01-08","2018-01-17","2020-05-11","Yes","HoFH","Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","12 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"2017-003170-13","EudraCT Number","Incidence and severity of treatment-emergent adverse events (TEAEs)","Up to 192 weeks",null,"Percent change in Low-Density Lipoprotein Cholesterol (LDL-C) over time|Absolute change in LDL-C over time|Percent change in Apolipoprotein B (Apo B) over time|Absolute change in Apo B over time|Percent change in non-High-Density Lipoprotein Cholesterol (HDL-C) over time|Absolute change in non-HDL-C over time|Percent change in Total Cholesterol (TC) over time|Absolute change in TC over time|Percent change in Triglycerides (TGs) over time|Absolute change in TGs over time|Presence of anti-evinacumab antibodies","Up to 192 weeks",{"$nulls":4},"Perth, Western|Camperdown, New South Wales, Australia, 2050|Innsbruck, Austria, 6020|Vienna, Wien, Austria, 1090|Quebec, Canada, G1V 4W2|Chicoutimi, Quebec, Canada, G7H 7K9|Praha 2, KateÅ™inskÃ¡, Czechia, 121 08|Paris, Cedex 13, France, 75651|Marseille, Cedex 5, France, 13385|Dijon, Cedex, France, 21079|Kallithea, Athens, Greece, 17674|Ioannina, Greece, 45500|Napoli, Campania, Italy, 80131|Roma, Rome, Italy, 161|Kurume, Fukuoka, Japan, 830-8522|Nishinomiya, Hyogo, Japan, 662-0918|Kanazawa, Ishikawa, Japan, 920-8641|Kita-Ku, Osaka, Japan, 530-0001 Regeneron Study SiteSuita, Osaka, Japan, 564-8565 Regeneron Study SiteSuita, Osaka, Japan, 565-0871|Amsterdam, Netherlands, 1105 Az|Johannesburg, Gauteng, South Africa, 2000|Cape Town, Western Cape, South Africa, 7925|Ivano-Frankivsk, Ukraine, 76075 Clinical Trial Site #1Kharkiv, Ukraine, 61039 Clinical Trial Site #2Kharkiv, Ukraine, 61176 Clinical Trial SiteKyiv, Ukraine, 02660 Rgeneron Study SiteKyiv, Ukraine, 3680|Los Angeles, California, United States, 90048|Boca Raton, Florida, United States, 33434|Boston, Massachusetts, United States, 02114|New York, New York, United States, 10029|Cincinnati, Ohio, United States, 45227|Portland, Oregon, United States, 97239|Philadelphia, Pennsylvania, United States, 19104|Dallas, Texas, United States, 75226 Clinical Trial SiteDallas, Texas, United States, 75390","California|Florida|Massachusetts|New York|Ohio|Oregon|Pennsylvania|Texas","Australia|Austria|Canada|Czechia|France|Greece|Italy|Japan|Netherlands|South Africa|Ukraine|United States","Clinical Trial Site|New South Wales Clinical Trial Site|Regeneron Study Site|Wien Regeneron Study Site|Quebec Clinical Trial Site|KateÅ™inskÃ¡ Regeneron Study Site|Cedex 13 Clinical Trial Site|Cedex 5 Clinical Trial Site|Cedex Clinical Trial Site|Athens Regeneron Study Site|Campania Clinical Trial Site|Rome Clinical Trial Site|Fukuoka Regeneron Study Site|Hyogo Regeneron Study Site|Ishikawa Regeneron Study Site|Osaka Regeneron Study Site|, Gauteng Regeneron Study Site|, Western Cape Regeneron Study Site",{"$nulls":3},"Clinical Trial Management","2020-05-11","2020-05-25T16:38:34.228","2020-05-26T17:10:42.972","NCT03409744"]
["5ecbf48ce2561b1b11905e38","NCT03410056","2018-01-25","Amgen","AMGN","Not yet recruiting","Safety and Efficacy of AMG 592 in Subjects With Active Rheumatoid Arthritis","Efavaleukin alfa","IL2 Inhibitor","Yes","['Efavaleukin alfa']","No",null,"Phase 1/Phase 2",2,105,"Anticipated","2018-01-24","2020-06-11",{"$nulls":5},"Phase 1b. To evaluate the safety and tolerability of subcutaneous (SC)dose administrations of AMG 592 in subjects with active RA.\n\nPhase 2a. To evaluate the efficacy of AMG 592 at week 12 as measured by the American College of Rheumatology 20% improvement criteria (ACR 20) in adult subjects with moderate to severe RA.",null,"A Phase 1b/2a Study to Evaluate the Safety and Efficacy of AMG 592 in Subjects With Active Rheumatoid Arthritis With Inadequate Response to Standard of Care Therapy",20170149,"Rheumatoid Arthritis RA","Arthritis|Arthritis, Rheumatoid","Joint Diseases","Musculoskeletal","Experimental|Placebo Comparator","AMG 592|Placebo","The phase 1b part of the study is a double-blind, placebo controlled, MAD study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of AMG 592 in subjects with active RA. The phase 2a part of the study will commence after a RP2D is identified in the phase 1b part of the study.","Drug","AMG 592|Placebo","AMG 592|Placebo",null,"AMG 592|Placebo","\n\n * Subject has provided informed consent prior to initiation of any study specific activities/procedures.\n * Age â‰¥ 18 to â‰¤ 70 years of age at screening.\n * A diagnosis of RA consistent with the 1987 or 2010 American College of Rheumatology (ACR)/European League Against Rheumatism classification criteria.\n * Active RA defined as: Phase 1b: DAS-28-CRP > 2.6 at screening. The 28-joint count consists of the finger joints excluding the distal interphalangeal joints, the wrists, elbows, shoulders, and knees. Phase 2a: â‰¥ 6 swollen joints (based on 66-joint count) and â‰¥ 6 tender joints (based on 68-joint count) at screening and baseline. The distal interphalangeal joint should be evaluated but not included in the total count to determine eligibility. Additionally, C-reactive protein (CRP) must be greater than the upper limit of normal (ULN) per the central laboratory at screening.\n * Receiving treatment with methotrexate for â‰¥ 12 weeks and on a stable dose â‰¥ 15 mg weekly for â‰¥ 8 weeks prior to day 1. A lower methotrexate dose is acceptable (but no lower than 10 mg weekly) if it is the highest tolerated dose and gastrointestinal or hematologic toxicity at doses â‰¥ 15 mg weekly is documented by the investigator.\n * Receiving treatment with folic or folinic acid per investigator judgment or according to local standard of care.\n * Phase 1b only: Subject may be receiving a stable dose of leflunomide, sulfasalazine, hydroxychloroquine, minocycline in combination with methotrexate and the dose must be stable for â‰¥ 8 weeks prior to day 1.\n * Subject may be receiving a stable dose of prednisone â‰¤ 10mg daily or other equivalent corticosteroid dose and the dose must be stable for â‰¥ 2 weeks prior today 1.\n * Phase 1b only. Normal or clinically acceptable ECG values (12-lead reporting ventricular rate and PR, QRS, QT and QTc interval) at screening and baseline based on opinion of the investigator.\n * Immunizations (tetanus, diphtheria, pertussis, seasonal influenza [during flu season], and pneumococcal [polysaccharide] vaccinations) up to date per local standards as determined by the investigator.\n\n","\n\n * Class IV RA according to ACR revised response criteria\n * Diagnosis of Felty's Syndrome (RA, splenomegaly and granulocytopenia).\n * Prosthetic joint infection within 3 years of screening or native joint infection within 1 year prior to screening.\n * Active infection (including chronic or localized infections) for which anti-infectives were indicated within 4 weeks prior to day 1 OR presence of serious infection, defined as requiring hospitalization or intravenous anti-infectives within 8 weeks prior to day 1.\n * Known history of active tuberculosis.\n * Positive test for tuberculosis during screening defined as either: positive purified protein derivative (PPD) (â‰¥ 5 mm of induration at 48 to 72 hours after test is placed) OR positive Quantiferon test: a positive PPD and a history of Bacillus Calmette-GuÃ©rin vaccination are allowed with a negative Quantiferon test and negative chest x ray; a positive PPD test (without a history of Bacillus Calmette-GuÃ©rin vaccination) or a positive or indeterminate Quantiferon test are allowed if they have ALL of the following at screening: no symptoms per tuberculosis or sheet provided by Amgen; document history of a completed course of adequate prophylaxis(completed treatment for latent tuberculosis per local standard of care prior to the start of investigational product); no known exposure to a case of active tuberculosis after most recent prophylaxis; negative chest X-ray.\n * Positive for hepatitis B surface antigen, hepatitis B core antibody (confirmed by hepatitis B DNA polymerase chain reaction [PCR] test) or detectable hepatitis C virus RNA by PCR (screening is generally done by hepatitis C antibody [HepCAb], followed by hepatitis C virus RNA by PCR if HepCAb is positive). A history of hepatitis B vaccination without history of hepatitis B is allowed.\n * Phase 1b only: Positive for Human Immunodeficiency Virus (HIV) at screening or known to be HIV positive. Phase 2a only: Known history of HIV\n * Positive drug or alcohol urine test at screening.\n * Presence of one or more significant concurrent medical conditions per investigator judgment, including but not limited to the following: poorly controlled diabetes or hypertension; chronic kidney disease stage IIIb, IV, or V; symptomatic heart failure (New York Heart Association class II, III, or IV); myocardial infarction or unstable angina pectoris within the past 12 months prior to randomization; severe chronic pulmonary disease (eg, requiring oxygen therapy); multiple sclerosis or any other demyelinating disease; major chronic inflammatory disease or connective tissue disease other than RA (eg, systemic lupus erythematosus with the exception of secondary SjÃ¶gren's syndrome).\n * Malignancy except non-melanoma skin cancers, cervical or breast ductal carcinoma in situ within the last 5 years.\n * History of alcohol or substance abuse within 6 months of screening\n * Phase 1b only: Current smoker, and/or use of any nicotine or tobacco containing products within the last 6 months prior to day 1. These types of products include but are not limited to: snuff, chewing tobacco, cigars, electronic cigarettes, cigarettes, pipes, or nicotine patches.\n * Phase 1b only: Subject unwilling to limit alcohol consumption to â‰¤ 1 drink of alcohol per day and â‰¤ 3 drinks per week for the duration of the study, where a drink is equivalent to 12 ounces of regular beer, 8 to 9 ounces of malt liquor, 5 ounces of wine, or 1.5 ounces of 80 proof distilled spirits. Phase 1b only: Unwilling or unable to abstain from alcohol consumption within 48 hours prior to each visit (including screening).\n * Subjects who have received intra-articular or systemic corticosteroid injections for treatment of acute RA flare (not being part of a regular therapeutic regimen) within 4 weeks prior to screening.\n * Currently receiving or had treatment with cyclophosphamide, chlorambucil, nitrogen mustard, or any other alkylating agent â‰¤ 6 months prior to day 1.\n * Prior use of > 1 biologic DMARD and prior use of a biologic DMARD occurred as follows:â€¢ â‰¤ 10 weeks prior to day 1 for infliximab, abatacept, tocilizumab, golimumab, certolizumab pegol, adalimumab â€¢ â‰¤ 4 weeks prior to day 1 for etanercept and anakinra â€¢ â‰¤ 6 months for rituximab\n * Currently receiving or had treatment with any of the following â‰¤ 12 weeks prior to day 1: * azathioprine\n    * cyclosporine\n    * gold\n    * mycophenolate mofetil\n    * Prosorba column\n    * Tacrolimus\n   \n   \n * Phase 2a only: Currently receiving or had treatment with leflunomide â‰¤ 12 weeks prior to day 1 unless an active washout with cholestyramine has been performed.\n * Phase 2a only: Currently receiving or had treatment with any of the following â‰¤ 4 weeks prior to day 1: * hydroxychloroquine\n    * sulfasalazine\n    * minocycline\n    * oral janus kinase inhibitor (eg, tofacitinib, baricitinib)\n    * intra-articular, intramuscular or intravenous corticosteroids, including adrenocorticotropic hormone\n    * intra-articular hyaluronic acid injections\n    * live vaccines\n   \n   \n * Unstable dose of non-steroidal anti-inflammatory drugs (NSAID), acetaminophen, and/or analgesics which is taken on an unscheduled basis (ie, not daily or scheduled every certain number of hours) and/or initiated <4 weeks prior to day 1.\n * Received the following within 12 hours prior to screening or day 1:\n\nacetaminophen, NSAIDs, tramadol, and/or any narcotic analgesics such as but not limited to hydrocodone, codeine, tramadol, propoxyphene and/or oxycodone (unless in the form of oxycontin). Subject has taken oxycontin within 24 hours prior to screening or day 1.\n\n * Phase 1b only: Received any herbal medicines (eg St John's wort), vitamins, and supplements within 4 weeks prior to day 1.\n * Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded.\n * Presence of laboratory abnormalities at screening including the following: * Aspartate aminotransferase (AST) or alanine amino transferase (ALT) at screening > 1.5X upper limit of normal (ULN)\n    * Serum total bilirubin (TBL) â‰¥ 1.5 mg/dL (â‰¥ 26 Î¼mol/L)\n    * Hemoglobin â‰¤ 10.5 g/dL(< 105 g/L)\n    * Platelet count < 100,000/mm3 (125 x 109/L)\n    * White blood cell count < 3,000 cells/mm3 (3.0 x 109/L)\n    * Absolute neutrophil count (ANC) < 1,500/mm3 (1.5 x 109/L)\n    * Calculated glomerular filtration rate of â‰¤ 50 mL/min/1.73 m2 using the Modification of Diet in Renal Disease (MDRD) formula\n   \n   \n * Any other laboratory abnormality, which, in the opinion of the investigator, poses a safety risk, will prevent the subject from completing the study, will interfere with the interpretation of the study results, or might cause the study to be detrimental to the subject.\n * Female subject is pregnant or breastfeeding or planning to become pregnant or breastfeed during treatment and for an additional 6 weeks after the last dose of investigational product.\n * Females of child-bearing potential with a positive pregnancy test (assessed by a serum pregnancy test at screening and a urine pregnancy test at baseline).\n * Female subjects of childbearing potential unwilling to use 1 highly effective method of contraception during treatment and for an additional 6 weeks after the last dose of investigational product. Refer to Appendix 5 for additional contraceptive information.\n * Subject has known sensitivity to any of the products or components to be administered during dosing.\n * Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures (eg, Clinical Outcome Assessments [COAs]) to the best of the subject and investigator's knowledge.\n * History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion","CRP","C-reactive protein","Protein","Breast","Actual","2018-01-25","Actual","Anticipated","2020-07-23","Anticipated","2018-01-01","2018-01-03","2018-01-18","2018-01-18","No",null,"Interventional","Treatment","Sequential Assignment","Double (Participant, Investigator)","Randomized","18 Years","70 Years","All",null,"Yes",null,null,"URL: http://www.amgentrials.com [http://www.amgentrials.com] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: AmgenTrials clinical trials website",null,"Yes","No",{"$nulls":17},"2017â€\u0090001944â€\u009036","EudraCT Number","ACR 20","The primary endpoint, ACR 20 at week 12, will be assessed between AMG 592 and placebo in the 2 populations respectively.","Week 12","ACR 50/70|DAS28-ESR|DAS 28-CRP|Maximum observed concentration (Cmax) of AMG592|Time of maximum observed concentration (Tmax) of AMG592|Area under the concentration-time curve (AUCtau) of AMG592","Evaluate the effect of treatment with AMG592 on ACR 50/70 change from baseline at week 12.|Evaluate the effect of treatment with AMG on disease activity score (28 joint) calculated using the erythrocyte sedimentation rate formula (DAS28-ESR) score and change from baseline at week 12.|Evaluate the effect of treatment with AMG on disease activity score (28 joint) calculated using the c-reactive protein formula (DAS 28-CRP) score and change from baseline at week 12.|Analyze serum concentrations of AMG592","Week 12","medinfo@amgen.com","Amgen Call Center","866-572-6436","Swidnik, Poland, 21-040",null,"Poland","Research Site",{"$nulls":3},"MD","2018-01-18","2020-05-25T16:38:36.266","2020-05-26T17:10:42.972","NCT03410056"]
["5ecbf48cfeab101b1553096d","NCT03410056","2018-04-20","Amgen","AMGN","Recruiting","Safety and Efficacy of AMG 592 in Subjects With Active Rheumatoid Arthritis","Efavaleukin alfa","IL2 Inhibitor","Yes","['Efavaleukin alfa']","No",null,"Phase 1/Phase 2",2,105,"Anticipated","2018-04-24","2020-06-11",{"$nulls":5},"Phase 1b. To evaluate the safety and tolerability of subcutaneous (SC)dose administrations of AMG 592 in subjects with active RA.\n\nPhase 2a. To evaluate the efficacy of AMG 592 at week 12 as measured by the American College of Rheumatology 20% improvement criteria (ACR 20) in adult subjects with moderate to severe RA.",null,"A Phase 1b/2a Study to Evaluate the Safety and Efficacy of AMG 592 in Subjects With Active Rheumatoid Arthritis With Inadequate Response to Standard of Care Therapy",20170149,"Rheumatoid Arthritis RA","Arthritis|Arthritis, Rheumatoid","Joint Diseases","Musculoskeletal","Experimental|Placebo Comparator","AMG 592|Placebo","The phase 1b part of the study is a double-blind, placebo controlled, MAD study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of AMG 592 in subjects with active RA. The phase 2a part of the study will commence after a RP2D is identified in the phase 1b part of the study.","Drug","AMG 592|Placebo","AMG 592|Placebo",null,"AMG 592|Placebo","\n\n * Subject has provided informed consent prior to initiation of any study specific activities/procedures.\n * Age â‰¥ 18 to â‰¤ 70 years of age at screening.\n * A diagnosis of RA consistent with the 1987 or 2010 American College of Rheumatology (ACR)/European League Against Rheumatism classification criteria.\n * Active RA defined as: Phase 1b: DAS-28-CRP > 2.6 at screening. The 28-joint count consists of the finger joints excluding the distal interphalangeal joints, the wrists, elbows, shoulders, and knees. Phase 2a: â‰¥ 6 swollen joints (based on 66-joint count) and â‰¥ 6 tender joints (based on 68-joint count) at screening and baseline. The distal interphalangeal joint should be evaluated but not included in the total count to determine eligibility. Additionally, C-reactive protein (CRP) must be greater than the upper limit of normal (ULN) per the central laboratory at screening.\n * Receiving treatment with methotrexate for â‰¥ 12 weeks and on a stable dose â‰¥ 15 mg weekly for â‰¥ 8 weeks prior to day 1. A lower methotrexate dose is acceptable (but no lower than 10 mg weekly) if it is the highest tolerated dose and gastrointestinal or hematologic toxicity at doses â‰¥ 15 mg weekly is documented by the investigator.\n * Receiving treatment with folic or folinic acid per investigator judgment or according to local standard of care.\n * Phase 1b only: Subject may be receiving a stable dose of leflunomide, sulfasalazine, hydroxychloroquine, minocycline in combination with methotrexate and the dose must be stable for â‰¥ 8 weeks prior to day 1.\n * Subject may be receiving a stable dose of prednisone â‰¤ 10mg daily or other equivalent corticosteroid dose and the dose must be stable for â‰¥ 2 weeks prior today 1.\n * Phase 1b only. Normal or clinically acceptable ECG values (12-lead reporting ventricular rate and PR, QRS, QT and QTc interval) at screening and baseline based on opinion of the investigator.\n * Immunizations (tetanus, diphtheria, pertussis, seasonal influenza [during flu season], and pneumococcal [polysaccharide] vaccinations) up to date per local standards as determined by the investigator.\n\n","\n\n * Class IV RA according to ACR revised response criteria\n * Diagnosis of Felty's Syndrome (RA, splenomegaly and granulocytopenia).\n * Prosthetic joint infection within 3 years of screening or native joint infection within 1 year prior to screening.\n * Active infection (including chronic or localized infections) for which anti-infectives were indicated within 4 weeks prior to day 1 OR presence of serious infection, defined as requiring hospitalization or intravenous anti-infectives within 8 weeks prior to day 1.\n * Known history of active tuberculosis.\n * Positive test for tuberculosis during screening defined as either: positive purified protein derivative (PPD) (â‰¥ 5 mm of induration at 48 to 72 hours after test is placed) OR positive Quantiferon test: a positive PPD and a history of Bacillus Calmette-GuÃ©rin vaccination are allowed with a negative Quantiferon test and negative chest x ray; a positive PPD test (without a history of Bacillus Calmette-GuÃ©rin vaccination) or a positive or indeterminate Quantiferon test are allowed if they have ALL of the following at screening: no symptoms per tuberculosis or sheet provided by Amgen; document history of a completed course of adequate prophylaxis(completed treatment for latent tuberculosis per local standard of care prior to the start of investigational product); no known exposure to a case of active tuberculosis after most recent prophylaxis; negative chest X-ray.\n * Positive for hepatitis B surface antigen, hepatitis B core antibody (confirmed by hepatitis B DNA polymerase chain reaction [PCR] test) or detectable hepatitis C virus RNA by PCR (screening is generally done by hepatitis C antibody [HepCAb], followed by hepatitis C virus RNA by PCR if HepCAb is positive). A history of hepatitis B vaccination without history of hepatitis B is allowed.\n * Phase 1b only: Positive for Human Immunodeficiency Virus (HIV) at screening or known to be HIV positive. Phase 2a only: Known history of HIV\n * Positive drug or alcohol urine test at screening.\n * Presence of one or more significant concurrent medical conditions per investigator judgment, including but not limited to the following: poorly controlled diabetes or hypertension; chronic kidney disease stage IIIb, IV, or V; symptomatic heart failure (New York Heart Association class II, III, or IV); myocardial infarction or unstable angina pectoris within the past 12 months prior to randomization; severe chronic pulmonary disease (eg, requiring oxygen therapy); multiple sclerosis or any other demyelinating disease; major chronic inflammatory disease or connective tissue disease other than RA (eg, systemic lupus erythematosus with the exception of secondary SjÃ¶gren's syndrome).\n * Malignancy except non-melanoma skin cancers, cervical or breast ductal carcinoma in situ within the last 5 years.\n * History of alcohol or substance abuse within 6 months of screening\n * Phase 1b only: Current smoker, and/or use of any nicotine or tobacco containing products within the last 6 months prior to day 1. These types of products include but are not limited to: snuff, chewing tobacco, cigars, electronic cigarettes, cigarettes, pipes, or nicotine patches.\n * Phase 1b only: Subject unwilling to limit alcohol consumption to â‰¤ 1 drink of alcohol per day and â‰¤ 3 drinks per week for the duration of the study, where a drink is equivalent to 12 ounces of regular beer, 8 to 9 ounces of malt liquor, 5 ounces of wine, or 1.5 ounces of 80 proof distilled spirits. Phase 1b only: Unwilling or unable to abstain from alcohol consumption within 48 hours prior to each visit (including screening).\n * Subjects who have received intra-articular or systemic corticosteroid injections for treatment of acute RA flare (not being part of a regular therapeutic regimen) within 4 weeks prior to screening.\n * Currently receiving or had treatment with cyclophosphamide, chlorambucil, nitrogen mustard, or any other alkylating agent â‰¤ 6 months prior to day 1.\n * Prior use of > 1 biologic DMARD and prior use of a biologic DMARD occurred as follows:â€¢ â‰¤ 10 weeks prior to day 1 for infliximab, abatacept, tocilizumab, golimumab, certolizumab pegol, adalimumab â€¢ â‰¤ 4 weeks prior to day 1 for etanercept and anakinra â€¢ â‰¤ 6 months for rituximab\n * Currently receiving or had treatment with any of the following â‰¤ 12 weeks prior to day 1: * azathioprine\n    * cyclosporine\n    * gold\n    * mycophenolate mofetil\n    * Prosorba column\n    * Tacrolimus\n   \n   \n * Phase 2a only: Currently receiving or had treatment with leflunomide â‰¤ 12 weeks prior to day 1 unless an active washout with cholestyramine has been performed.\n * Phase 2a only: Currently receiving or had treatment with any of the following â‰¤ 4 weeks prior to day 1: * hydroxychloroquine\n    * sulfasalazine\n    * minocycline\n    * oral janus kinase inhibitor (eg, tofacitinib, baricitinib)\n    * intra-articular, intramuscular or intravenous corticosteroids, including adrenocorticotropic hormone\n    * intra-articular hyaluronic acid injections\n    * live vaccines\n   \n   \n * Unstable dose of non-steroidal anti-inflammatory drugs (NSAID), acetaminophen, and/or analgesics which is taken on an unscheduled basis (ie, not daily or scheduled every certain number of hours) and/or initiated <4 weeks prior to day 1.\n * Received the following within 12 hours prior to screening or day 1:\n\nacetaminophen, NSAIDs, tramadol, and/or any narcotic analgesics such as but not limited to hydrocodone, codeine, tramadol, propoxyphene and/or oxycodone (unless in the form of oxycontin). Subject has taken oxycontin within 24 hours prior to screening or day 1.\n\n * Phase 1b only: Received any herbal medicines (eg St John's wort), vitamins, and supplements within 4 weeks prior to day 1.\n * Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded.\n * Presence of laboratory abnormalities at screening including the following: * Aspartate aminotransferase (AST) or alanine amino transferase (ALT) at screening > 1.5X upper limit of normal (ULN)\n    * Serum total bilirubin (TBL) â‰¥ 1.5 mg/dL (â‰¥ 26 Î¼mol/L)\n    * Hemoglobin â‰¤ 10.5 g/dL(< 105 g/L)\n    * Platelet count < 100,000/mm3 (125 x 109/L)\n    * White blood cell count < 3,000 cells/mm3 (3.0 x 109/L)\n    * Absolute neutrophil count (ANC) < 1,500/mm3 (1.5 x 109/L)\n    * Calculated glomerular filtration rate of â‰¤ 50 mL/min/1.73 m2 using the Modification of Diet in Renal Disease (MDRD) formula\n   \n   \n * Any other laboratory abnormality, which, in the opinion of the investigator, poses a safety risk, will prevent the subject from completing the study, will interfere with the interpretation of the study results, or might cause the study to be detrimental to the subject.\n * Female subject is pregnant or breastfeeding or planning to become pregnant or breastfeed during treatment and for an additional 6 weeks after the last dose of investigational product.\n * Females of child-bearing potential with a positive pregnancy test (assessed by a serum pregnancy test at screening and a urine pregnancy test at baseline).\n * Female subjects of childbearing potential unwilling to use 1 highly effective method of contraception during treatment and for an additional 6 weeks after the last dose of investigational product. Refer to Appendix 5 for additional contraceptive information.\n * Subject has known sensitivity to any of the products or components to be administered during dosing.\n * Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures (eg, Clinical Outcome Assessments [COAs]) to the best of the subject and investigator's knowledge.\n * History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion","CRP","C-reactive protein","Protein","Breast","Actual","2018-01-25","Actual","Anticipated","2020-07-23","Anticipated","2018-04-01","2018-01-03","2018-01-18","2018-04-18","No",null,"Interventional","Treatment","Sequential Assignment","Double (Participant, Investigator)","Randomized","18 Years","70 Years","All",null,"Yes",null,null,"URL: http://www.amgentrials.com [http://www.amgentrials.com] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: AmgenTrials clinical trials website",null,"Yes","No",{"$nulls":17},"2017â€\u0090001944â€\u009036","EudraCT Number","ACR 20","The primary endpoint, ACR 20 at week 12, will be assessed between AMG 592 and placebo in the 2 populations respectively.","Week 12","ACR 50/70|DAS28-ESR|DAS 28-CRP|Maximum observed concentration (Cmax) of AMG592|Time of maximum observed concentration (Tmax) of AMG592|Area under the concentration-time curve (AUCtau) of AMG592","Evaluate the effect of treatment with AMG592 on ACR 50/70 change from baseline at week 12.|Evaluate the effect of treatment with AMG on disease activity score (28 joint) calculated using the erythrocyte sedimentation rate formula (DAS28-ESR) score and change from baseline at week 12.|Evaluate the effect of treatment with AMG on disease activity score (28 joint) calculated using the c-reactive protein formula (DAS 28-CRP) score and change from baseline at week 12.|Analyze serum concentrations of AMG592","Week 12","medinfo@amgen.com","Amgen Call Center","866-572-6436","Sofia, Bulgaria, 1612|Stalowa Wola, Poland, 37-450 Research SiteSwidnik, Poland, 21-040 Research SiteWarszawa, Poland, 02-797 Research SiteWroclaw, Poland, 51-128|Anniston, Alabama, United States, 36207|Dallas, Texas, United States, 75231","Alabama|Texas","Bulgaria|Poland|United States","Research Site",{"$nulls":3},"MD","2018-04-18","2020-05-25T16:38:36.391","2020-05-26T17:10:42.972","NCT03410056"]
["5ecbf48c307e3d1b1f8d9dcf","NCT03410056","2018-05-15","Amgen","AMGN","Recruiting","Safety and Efficacy of AMG 592 in Subjects With Active Rheumatoid Arthritis","Efavaleukin alfa","IL2 Inhibitor","Yes","['Efavaleukin alfa']","No",null,"Phase 1/Phase 2",2,105,"Anticipated","2018-05-24","2020-06-11",{"$nulls":5},"Phase 1b. To evaluate the safety and tolerability of subcutaneous (SC)dose administrations of AMG 592 in subjects with active RA.\n\nPhase 2a. To evaluate the efficacy of AMG 592 at week 12 as measured by the American College of Rheumatology 20% improvement criteria (ACR 20) in adult subjects with moderate to severe RA.",null,"A Phase 1b/2a Study to Evaluate the Safety and Efficacy of AMG 592 in Subjects With Active Rheumatoid Arthritis With Inadequate Response to Standard of Care Therapy",20170149,"Rheumatoid Arthritis RA","Arthritis|Arthritis, Rheumatoid","Joint Diseases","Musculoskeletal","Experimental|Placebo Comparator","AMG 592|Placebo","The phase 1b part of the study is a double-blind, placebo controlled, MAD study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of AMG 592 in subjects with active RA. The phase 2a part of the study will commence after a RP2D is identified in the phase 1b part of the study.","Drug","AMG 592|Placebo","AMG 592|Placebo",null,"AMG 592|Placebo","\n\n * Subject has provided informed consent prior to initiation of any study specific activities/procedures.\n * Age â‰¥ 18 to â‰¤ 70 years of age at screening.\n * A diagnosis of RA consistent with the 1987 or 2010 American College of Rheumatology (ACR)/European League Against Rheumatism classification criteria.\n * Active RA defined as: Phase 1b: DAS-28-CRP > 2.6 at screening. The 28-joint count consists of the finger joints excluding the distal interphalangeal joints, the wrists, elbows, shoulders, and knees. Phase 2a: â‰¥ 6 swollen joints (based on 66-joint count) and â‰¥ 6 tender joints (based on 68-joint count) at screening and baseline. The distal interphalangeal joint should be evaluated but not included in the total count to determine eligibility. Additionally, C-reactive protein (CRP) must be greater than the upper limit of normal (ULN) per the central laboratory at screening.\n * Receiving treatment with methotrexate for â‰¥ 12 weeks and on a stable dose â‰¥ 15 mg weekly for â‰¥ 8 weeks prior to day 1. A lower methotrexate dose is acceptable (but no lower than 10 mg weekly) if it is the highest tolerated dose and gastrointestinal or hematologic toxicity at doses â‰¥ 15 mg weekly is documented by the investigator.\n * Receiving treatment with folic or folinic acid per investigator judgment or according to local standard of care.\n * Phase 1b only: Subject may be receiving a stable dose of leflunomide, sulfasalazine, hydroxychloroquine, minocycline in combination with methotrexate and the dose must be stable for â‰¥ 8 weeks prior to day 1.\n * Subject may be receiving a stable dose of prednisone â‰¤ 10mg daily or other equivalent corticosteroid dose and the dose must be stable for â‰¥ 2 weeks prior today 1.\n * Phase 1b only. Normal or clinically acceptable ECG values (12-lead reporting ventricular rate and PR, QRS, QT and QTc interval) at screening and baseline based on opinion of the investigator.\n * Immunizations (tetanus, diphtheria, pertussis, seasonal influenza [during flu season], and pneumococcal [polysaccharide] vaccinations) up to date per local standards as determined by the investigator.\n\n","\n\n * Class IV RA according to ACR revised response criteria\n * Diagnosis of Felty's Syndrome (RA, splenomegaly and granulocytopenia).\n * Prosthetic joint infection within 3 years of screening or native joint infection within 1 year prior to screening.\n * Active infection (including chronic or localized infections) for which anti-infectives were indicated within 4 weeks prior to day 1 OR presence of serious infection, defined as requiring hospitalization or intravenous anti-infectives within 8 weeks prior to day 1.\n * Known history of active tuberculosis.\n * Positive test for tuberculosis during screening defined as either: positive purified protein derivative (PPD) (â‰¥ 5 mm of induration at 48 to 72 hours after test is placed) OR positive Quantiferon test: a positive PPD and a history of Bacillus Calmette-GuÃ©rin vaccination are allowed with a negative Quantiferon test and negative chest x ray; a positive PPD test (without a history of Bacillus Calmette-GuÃ©rin vaccination) or a positive or indeterminate Quantiferon test are allowed if they have ALL of the following at screening: no symptoms per tuberculosis or sheet provided by Amgen; document history of a completed course of adequate prophylaxis(completed treatment for latent tuberculosis per local standard of care prior to the start of investigational product); no known exposure to a case of active tuberculosis after most recent prophylaxis; negative chest X-ray.\n * Positive for hepatitis B surface antigen, hepatitis B core antibody (confirmed by hepatitis B DNA polymerase chain reaction [PCR] test) or detectable hepatitis C virus RNA by PCR (screening is generally done by hepatitis C antibody [HepCAb], followed by hepatitis C virus RNA by PCR if HepCAb is positive). A history of hepatitis B vaccination without history of hepatitis B is allowed.\n * Phase 1b only: Positive for Human Immunodeficiency Virus (HIV) at screening or known to be HIV positive. Phase 2a only: Known history of HIV\n * Positive drug or alcohol urine test at screening.\n * Presence of one or more significant concurrent medical conditions per investigator judgment, including but not limited to the following: poorly controlled diabetes or hypertension; chronic kidney disease stage IIIb, IV, or V; symptomatic heart failure (New York Heart Association class II, III, or IV); myocardial infarction or unstable angina pectoris within the past 12 months prior to randomization; severe chronic pulmonary disease (eg, requiring oxygen therapy); multiple sclerosis or any other demyelinating disease; major chronic inflammatory disease or connective tissue disease other than RA (eg, systemic lupus erythematosus with the exception of secondary SjÃ¶gren's syndrome).\n * Malignancy except non-melanoma skin cancers, cervical or breast ductal carcinoma in situ within the last 5 years.\n * History of alcohol or substance abuse within 6 months of screening\n * Phase 1b only: Current smoker, and/or use of any nicotine or tobacco containing products within the last 6 months prior to day 1. These types of products include but are not limited to: snuff, chewing tobacco, cigars, electronic cigarettes, cigarettes, pipes, or nicotine patches.\n * Phase 1b only: Subject unwilling to limit alcohol consumption to â‰¤ 1 drink of alcohol per day and â‰¤ 3 drinks per week for the duration of the study, where a drink is equivalent to 12 ounces of regular beer, 8 to 9 ounces of malt liquor, 5 ounces of wine, or 1.5 ounces of 80 proof distilled spirits. Phase 1b only: Unwilling or unable to abstain from alcohol consumption within 48 hours prior to each visit (including screening).\n * Subjects who have received intra-articular or systemic corticosteroid injections for treatment of acute RA flare (not being part of a regular therapeutic regimen) within 4 weeks prior to screening.\n * Currently receiving or had treatment with cyclophosphamide, chlorambucil, nitrogen mustard, or any other alkylating agent â‰¤ 6 months prior to day 1.\n * Prior use of > 1 biologic DMARD and prior use of a biologic DMARD occurred as follows:â€¢ â‰¤ 10 weeks prior to day 1 for infliximab, abatacept, tocilizumab, golimumab, certolizumab pegol, adalimumab â€¢ â‰¤ 4 weeks prior to day 1 for etanercept and anakinra â€¢ â‰¤ 6 months for rituximab\n * Currently receiving or had treatment with any of the following â‰¤ 12 weeks prior to day 1: * azathioprine\n    * cyclosporine\n    * gold\n    * mycophenolate mofetil\n    * Prosorba column\n    * Tacrolimus\n   \n   \n * Phase 2a only: Currently receiving or had treatment with leflunomide â‰¤ 12 weeks prior to day 1 unless an active washout with cholestyramine has been performed.\n * Phase 2a only: Currently receiving or had treatment with any of the following â‰¤ 4 weeks prior to day 1: * hydroxychloroquine\n    * sulfasalazine\n    * minocycline\n    * oral janus kinase inhibitor (eg, tofacitinib, baricitinib)\n    * intra-articular, intramuscular or intravenous corticosteroids, including adrenocorticotropic hormone\n    * intra-articular hyaluronic acid injections\n    * live vaccines\n   \n   \n * Unstable dose of non-steroidal anti-inflammatory drugs (NSAID), acetaminophen, and/or analgesics which is taken on an unscheduled basis (ie, not daily or scheduled every certain number of hours) and/or initiated <4 weeks prior to day 1.\n * Received the following within 12 hours prior to screening or day 1:\n\nacetaminophen, NSAIDs, tramadol, and/or any narcotic analgesics such as but not limited to hydrocodone, codeine, tramadol, propoxyphene and/or oxycodone (unless in the form of oxycontin). Subject has taken oxycontin within 24 hours prior to screening or day 1.\n\n * Phase 1b only: Received any herbal medicines (eg St John's wort), vitamins, and supplements within 4 weeks prior to day 1.\n * Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded.\n * Presence of laboratory abnormalities at screening including the following: * Aspartate aminotransferase (AST) or alanine amino transferase (ALT) at screening > 1.5X upper limit of normal (ULN)\n    * Serum total bilirubin (TBL) â‰¥ 1.5 mg/dL (â‰¥ 26 Î¼mol/L)\n    * Hemoglobin â‰¤ 10.5 g/dL(< 105 g/L)\n    * Platelet count < 100,000/mm3 (125 x 109/L)\n    * White blood cell count < 3,000 cells/mm3 (3.0 x 109/L)\n    * Absolute neutrophil count (ANC) < 1,500/mm3 (1.5 x 109/L)\n    * Calculated glomerular filtration rate of â‰¤ 50 mL/min/1.73 m2 using the Modification of Diet in Renal Disease (MDRD) formula\n   \n   \n * Any other laboratory abnormality, which, in the opinion of the investigator, poses a safety risk, will prevent the subject from completing the study, will interfere with the interpretation of the study results, or might cause the study to be detrimental to the subject.\n * Female subject is pregnant or breastfeeding or planning to become pregnant or breastfeed during treatment and for an additional 6 weeks after the last dose of investigational product.\n * Females of child-bearing potential with a positive pregnancy test (assessed by a serum pregnancy test at screening and a urine pregnancy test at baseline).\n * Female subjects of childbearing potential unwilling to use 1 highly effective method of contraception during treatment and for an additional 6 weeks after the last dose of investigational product. Refer to Appendix 5 for additional contraceptive information.\n * Subject has known sensitivity to any of the products or components to be administered during dosing.\n * Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures (eg, Clinical Outcome Assessments [COAs]) to the best of the subject and investigator's knowledge.\n * History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion","CRP","C-reactive protein","Protein","Breast","Actual","2018-01-25","Actual","Anticipated","2020-07-23","Anticipated","2018-05-01","2018-01-03","2018-01-18","2018-05-14","No",null,"Interventional","Treatment","Sequential Assignment","Double (Participant, Investigator)","Randomized","18 Years","70 Years","All",null,"Yes",null,null,"URL: http://www.amgentrials.com [http://www.amgentrials.com] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: AmgenTrials clinical trials website",null,"Yes","No",{"$nulls":17},"2017â€\u0090001944â€\u009036","EudraCT Number","ACR 20","The primary endpoint, ACR 20 at week 12, will be assessed between AMG 592 and placebo in the 2 populations respectively.","Week 12","ACR 50/70|DAS28-ESR|DAS 28-CRP|Maximum observed concentration (Cmax) of AMG592|Time of maximum observed concentration (Tmax) of AMG592|Area under the concentration-time curve (AUCtau) of AMG592","Evaluate the effect of treatment with AMG592 on ACR 50/70 change from baseline at week 12.|Evaluate the effect of treatment with AMG on disease activity score (28 joint) calculated using the erythrocyte sedimentation rate formula (DAS28-ESR) score and change from baseline at week 12.|Evaluate the effect of treatment with AMG on disease activity score (28 joint) calculated using the c-reactive protein formula (DAS 28-CRP) score and change from baseline at week 12.|Analyze serum concentrations of AMG592","Week 12","medinfo@amgen.com","Amgen Call Center","866-572-6436","Sofia, Bulgaria, 1612|Stalowa Wola, Poland, 37-450 Research SiteSwidnik, Poland, 21-040 Research SiteWarszawa, Poland, 02-797 Research SiteWroclaw, Poland, 51-128|Anniston, Alabama, United States, 36207|Dallas, Texas, United States, 75231","Alabama|Texas","Bulgaria|Poland|United States","Research Site",{"$nulls":3},"MD","2018-05-14","2020-05-25T16:38:36.317","2020-05-26T17:10:42.972","NCT03410056"]
["5ecbf48c307e3d1b1f8d9dd0","NCT03410056","2018-07-17","Amgen","AMGN","Recruiting","Safety and Efficacy of AMG 592 in Subjects With Active Rheumatoid Arthritis","Efavaleukin alfa","IL2 Inhibitor","Yes","['Efavaleukin alfa']","No",null,"Phase 1/Phase 2",2,105,"Anticipated","2018-05-22","2020-06-17",{"$nulls":5},"Phase 1b. To evaluate the safety and tolerability of subcutaneous (SC)dose administrations of AMG 592 in subjects with active RA.\n\nPhase 2a. To evaluate the efficacy of AMG 592 at week 12 as measured by the American College of Rheumatology 20% improvement criteria (ACR 20) in adult subjects with moderate to severe RA.",null,"A Phase 1b/2a Study to Evaluate the Safety and Efficacy of AMG 592 in Subjects With Active Rheumatoid Arthritis With Inadequate Response to Standard of Care Therapy",20170149,"Rheumatoid Arthritis RA","Arthritis|Arthritis, Rheumatoid","Joint Diseases","Musculoskeletal","Experimental|Placebo Comparator","AMG 592|Placebo","The phase 1b part of the study is a double-blind, placebo controlled, MAD study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of AMG 592 in subjects with active RA. The phase 2a part of the study will commence after a RP2D is identified in the phase 1b part of the study.","Drug","AMG 592|Placebo","AMG 592|Placebo",null,"AMG 592|Placebo","\n\n * Subject has provided informed consent prior to initiation of any study specific activities/procedures.\n * Age â‰¥ 18 to â‰¤ 70 years of age at screening.\n * A diagnosis of RA consistent with the 1987 or 2010 American College of Rheumatology (ACR)/European League Against Rheumatism classification criteria.\n * Active RA defined as: Phase 1b: DAS-28-CRP > 2.6 at screening. The 28-joint count consists of the finger joints excluding the distal interphalangeal joints, the wrists, elbows, shoulders, and knees. Phase 2a: â‰¥ 6 swollen joints (based on 66-joint count) and â‰¥ 6 tender joints (based on 68-joint count) at screening and baseline. The distal interphalangeal joint should be evaluated but not included in the total count to determine eligibility. Additionally, C-reactive protein (CRP) must be greater than the upper limit of normal (ULN) per the central laboratory at screening.\n * Receiving treatment with methotrexate for â‰¥ 12 weeks and on a stable dose â‰¥ 15 mg weekly for â‰¥ 8 weeks prior to day 1. A lower methotrexate dose is acceptable (but no lower than 10 mg weekly) if it is the highest tolerated dose and gastrointestinal or hematologic toxicity at doses â‰¥ 15 mg weekly is documented by the investigator.\n * Receiving treatment with folic or folinic acid per investigator judgment or according to local standard of care.\n * Phase 1b only: Subject may be receiving a stable dose of leflunomide, sulfasalazine, hydroxychloroquine, minocycline in combination with methotrexate and the dose must be stable for â‰¥ 8 weeks prior to day 1.\n * Subject may be receiving a stable dose of prednisone â‰¤ 10mg daily or other equivalent corticosteroid dose and the dose must be stable for â‰¥ 2 weeks prior today 1.\n * Phase 1b only. Normal or clinically acceptable ECG values (12-lead reporting ventricular rate and PR, QRS, QT and QTc interval) at screening and baseline based on opinion of the investigator.\n * Immunizations (tetanus, diphtheria, pertussis, seasonal influenza [during flu season], and pneumococcal [polysaccharide] vaccinations) up to date per local standards as determined by the investigator.\n\n","\n\n * Class IV RA according to ACR revised response criteria\n * Diagnosis of Felty's Syndrome (RA, splenomegaly and granulocytopenia).\n * Prosthetic joint infection within 3 years of screening or native joint infection within 1 year prior to screening.\n * Active infection (including chronic or localized infections) for which anti-infectives were indicated within 4 weeks prior to day 1 OR presence of serious infection, defined as requiring hospitalization or intravenous anti-infectives within 8 weeks prior to day 1.\n * Known history of active tuberculosis.\n * Positive test for tuberculosis during screening defined as either: positive purified protein derivative (PPD) (â‰¥ 5 mm of induration at 48 to 72 hours after test is placed) OR positive Quantiferon test: a positive PPD and a history of Bacillus Calmette-GuÃ©rin vaccination are allowed with a negative Quantiferon test and negative chest x ray; a positive PPD test (without a history of Bacillus Calmette-GuÃ©rin vaccination) or a positive or indeterminate Quantiferon test are allowed if they have ALL of the following at screening: no symptoms per tuberculosis or sheet provided by Amgen; document history of a completed course of adequate prophylaxis(completed treatment for latent tuberculosis per local standard of care prior to the start of investigational product); no known exposure to a case of active tuberculosis after most recent prophylaxis; negative chest X-ray.\n * Positive for hepatitis B surface antigen, hepatitis B core antibody (confirmed by hepatitis B DNA polymerase chain reaction [PCR] test) or detectable hepatitis C virus RNA by PCR (screening is generally done by hepatitis C antibody [HepCAb], followed by hepatitis C virus RNA by PCR if HepCAb is positive). A history of hepatitis B vaccination without history of hepatitis B is allowed.\n * Phase 1b only: Positive for Human Immunodeficiency Virus (HIV) at screening or known to be HIV positive. Phase 2a only: Known history of HIV\n * Positive drug or alcohol urine test at screening.\n * Presence of one or more significant concurrent medical conditions per investigator judgment, including but not limited to the following: poorly controlled diabetes or hypertension; chronic kidney disease stage IIIb, IV, or V; symptomatic heart failure (New York Heart Association class II, III, or IV); myocardial infarction or unstable angina pectoris within the past 12 months prior to randomization; severe chronic pulmonary disease (eg, requiring oxygen therapy); multiple sclerosis or any other demyelinating disease; major chronic inflammatory disease or connective tissue disease other than RA (eg, systemic lupus erythematosus with the exception of secondary SjÃ¶gren's syndrome).\n * Malignancy except non-melanoma skin cancers, cervical or breast ductal carcinoma in situ within the last 5 years.\n * History of alcohol or substance abuse within 6 months of screening\n * Phase 1b only: Current smoker, and/or use of any nicotine or tobacco containing products within the last 6 months prior to day 1. These types of products include but are not limited to: snuff, chewing tobacco, cigars, electronic cigarettes, cigarettes, pipes, or nicotine patches.\n * Phase 1b only: Subject unwilling to limit alcohol consumption to â‰¤ 1 drink of alcohol per day and â‰¤ 3 drinks per week for the duration of the study, where a drink is equivalent to 12 ounces of regular beer, 8 to 9 ounces of malt liquor, 5 ounces of wine, or 1.5 ounces of 80 proof distilled spirits. Phase 1b only: Unwilling or unable to abstain from alcohol consumption within 48 hours prior to each visit (including screening).\n * Subjects who have received intra-articular or systemic corticosteroid injections for treatment of acute RA flare (not being part of a regular therapeutic regimen) within 4 weeks prior to screening.\n * Currently receiving or had treatment with cyclophosphamide, chlorambucil, nitrogen mustard, or any other alkylating agent â‰¤ 6 months prior to day 1.\n * Prior use of > 1 biologic DMARD and prior use of a biologic DMARD occurred as follows:â€¢ â‰¤ 10 weeks prior to day 1 for infliximab, abatacept, tocilizumab, golimumab, certolizumab pegol, adalimumab â€¢ â‰¤ 4 weeks prior to day 1 for etanercept and anakinra â€¢ â‰¤ 6 months for rituximab\n * Currently receiving or had treatment with any of the following â‰¤ 12 weeks prior to day 1: * azathioprine\n    * cyclosporine\n    * gold\n    * mycophenolate mofetil\n    * Prosorba column\n    * Tacrolimus\n   \n   \n * Phase 2a only: Currently receiving or had treatment with leflunomide â‰¤ 12 weeks prior to day 1 unless an active washout with cholestyramine has been performed.\n * Phase 2a only: Currently receiving or had treatment with any of the following â‰¤ 4 weeks prior to day 1: * hydroxychloroquine\n    * sulfasalazine\n    * minocycline\n    * oral janus kinase inhibitor (eg, tofacitinib, baricitinib)\n    * intra-articular, intramuscular or intravenous corticosteroids, including adrenocorticotropic hormone\n    * intra-articular hyaluronic acid injections\n    * live vaccines\n   \n   \n * Unstable dose of non-steroidal anti-inflammatory drugs (NSAID), acetaminophen, and/or analgesics which is taken on an unscheduled basis (ie, not daily or scheduled every certain number of hours) and/or initiated <4 weeks prior to day 1.\n * Received the following within 12 hours prior to screening or day 1:\n\nacetaminophen, NSAIDs, tramadol, and/or any narcotic analgesics such as but not limited to hydrocodone, codeine, tramadol, propoxyphene and/or oxycodone (unless in the form of oxycontin). Subject has taken oxycontin within 24 hours prior to screening or day 1.\n\n * Phase 1b only: Received any herbal medicines (eg St John's wort), vitamins, and supplements within 4 weeks prior to day 1.\n * Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded.\n * Presence of laboratory abnormalities at screening including the following: * Aspartate aminotransferase (AST) or alanine amino transferase (ALT) at screening > 1.5X upper limit of normal (ULN)\n    * Serum total bilirubin (TBL) â‰¥ 1.5 mg/dL (â‰¥ 26 Î¼mol/L)\n    * Hemoglobin â‰¤ 10.5 g/dL(< 105 g/L)\n    * Platelet count < 100,000/mm3 (125 x 109/L)\n    * White blood cell count < 3,000 cells/mm3 (3.0 x 109/L)\n    * Absolute neutrophil count (ANC) < 1,500/mm3 (1.5 x 109/L)\n    * Calculated glomerular filtration rate of â‰¤ 50 mL/min/1.73 m2 using the Modification of Diet in Renal Disease (MDRD) formula\n   \n   \n * Any other laboratory abnormality, which, in the opinion of the investigator, poses a safety risk, will prevent the subject from completing the study, will interfere with the interpretation of the study results, or might cause the study to be detrimental to the subject.\n * Female subject is pregnant or breastfeeding or planning to become pregnant or breastfeed during treatment and for an additional 6 weeks after the last dose of investigational product.\n * Females of child-bearing potential with a positive pregnancy test (assessed by a serum pregnancy test at screening and a urine pregnancy test at baseline).\n * Female subjects of childbearing potential unwilling to use 1 highly effective method of contraception during treatment and for an additional 6 weeks after the last dose of investigational product. Refer to Appendix 5 for additional contraceptive information.\n * Subject has known sensitivity to any of the products or components to be administered during dosing.\n * Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures (eg, Clinical Outcome Assessments [COAs]) to the best of the subject and investigator's knowledge.\n * History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion","CRP","C-reactive protein","Protein","Breast","Actual","2018-01-25","Actual","Anticipated","2020-07-29","Anticipated","2018-07-01","2018-01-03","2018-01-18","2018-07-16","No",null,"Interventional","Treatment","Sequential Assignment","Double (Participant, Investigator)","Randomized","18 Years","70 Years","All",null,"Yes",null,null,"URL: http://www.amgentrials.com [http://www.amgentrials.com] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: AmgenTrials clinical trials website",null,"Yes","No",{"$nulls":17},"2017â€\u0090001944â€\u009036","EudraCT Number","ACR 20","The primary endpoint, ACR 20 at week 12, will be assessed between AMG 592 and placebo in the 2 populations respectively.","Week 12","ACR 50/70|DAS28-ESR|DAS 28-CRP|Maximum observed concentration (Cmax) of AMG592|Time of maximum observed concentration (Tmax) of AMG592|Area under the concentration-time curve (AUCtau) of AMG592","Evaluate the effect of treatment with AMG592 on ACR 50/70 change from baseline at week 12.|Evaluate the effect of treatment with AMG on disease activity score (28 joint) calculated using the erythrocyte sedimentation rate formula (DAS28-ESR) score and change from baseline at week 12.|Evaluate the effect of treatment with AMG on disease activity score (28 joint) calculated using the c-reactive protein formula (DAS 28-CRP) score and change from baseline at week 12.|Analyze serum concentrations of AMG592","Week 12","medinfo@amgen.com","Amgen Call Center","866-572-6436","Sofia, Bulgaria, 1612|Berlin, Germany, 10117 Research SiteFrankfurt Am Main, Germany, 60590|Krakow, Poland, 30-348 Research SiteStalowa Wola, Poland, 37-450 Research SiteSwidnik, Poland, 21-040 Research SiteWarszawa, Poland, 02-797 Research SiteWroclaw, Poland, 51-128|A CoruÃ±a, Galicia, Spain, 15006|Anniston, Alabama, United States, 36207|Lansing, Michigan, United States, 48910|Dallas, Texas, United States, 75231","Alabama|Michigan|Texas","Bulgaria|Germany|Poland|Spain|United States","Research Site|Galicia Research Site",{"$nulls":3},"MD","2018-07-16","2020-05-25T16:38:36.662","2020-05-26T17:10:42.972","NCT03410056"]
["5ecbf48cfe30261b1a048340","NCT03410056","2018-10-19","Amgen","AMGN","Recruiting","Safety and Efficacy of AMG 592 in Subjects With Active Rheumatoid Arthritis","Efavaleukin alfa","IL2 Inhibitor","Yes","['Efavaleukin alfa']","No",null,"Phase 1/Phase 2",2,105,"Anticipated","2018-05-22","2020-09-07",{"$nulls":5},"Phase 1b. To evaluate the safety and tolerability of subcutaneous (SC)dose administrations of AMG 592 in subjects with active RA.\n\nPhase 2a. To evaluate the efficacy of AMG 592 at week 12 as measured by the American College of Rheumatology 20% improvement criteria (ACR 20) in adult subjects with moderate to severe RA.",null,"A Phase 1b/2a Study to Evaluate the Safety and Efficacy of AMG 592 in Subjects With Active Rheumatoid Arthritis With Inadequate Response to Standard of Care Therapy",20170149,"Rheumatoid Arthritis RA","Arthritis|Arthritis, Rheumatoid","Joint Diseases","Musculoskeletal","Experimental|Placebo Comparator","AMG 592|Placebo","The phase 1b part of the study is a double-blind, placebo controlled, MAD study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of AMG 592 in subjects with active RA. The phase 2a part of the study will commence after a RP2D is identified in the phase 1b part of the study.","Drug","AMG 592|Placebo","AMG 592|Placebo",null,"AMG 592|Placebo","\n\n * Subject has provided informed consent prior to initiation of any study specific activities/procedures.\n * Age â‰¥ 18 to â‰¤ 70 years of age at screening.\n * A diagnosis of RA consistent with the 1987 or 2010 American College of Rheumatology (ACR)/European League Against Rheumatism classification criteria.\n * Active RA defined as: Phase 1b: DAS-28-CRP > 2.6 at screening. The 28-joint count consists of the finger joints excluding the distal interphalangeal joints, the wrists, elbows, shoulders, and knees. Phase 2a: â‰¥ 6 swollen joints (based on 66-joint count) and â‰¥ 6 tender joints (based on 68-joint count) at screening and baseline. The distal interphalangeal joint should be evaluated but not included in the total count to determine eligibility. Additionally, C-reactive protein (CRP) must be greater than the upper limit of normal (ULN) per the central laboratory at screening.\n * Receiving treatment with methotrexate for â‰¥ 12 weeks and on a stable dose â‰¥ 15 mg weekly for â‰¥ 8 weeks prior to day 1. A lower methotrexate dose is acceptable (but no lower than 10 mg weekly) if it is the highest tolerated dose and gastrointestinal or hematologic toxicity at doses â‰¥ 15 mg weekly is documented by the investigator.\n * Receiving treatment with folic or folinic acid per investigator judgment or according to local standard of care.\n * Phase 1b only: Subject may be receiving a stable dose of leflunomide, sulfasalazine, hydroxychloroquine, minocycline in combination with methotrexate and the dose must be stable for â‰¥ 8 weeks prior to day 1.\n * Subject may be receiving a stable dose of prednisone â‰¤ 10mg daily or other equivalent corticosteroid dose and the dose must be stable for â‰¥ 2 weeks prior today 1.\n * Phase 1b only. Normal or clinically acceptable ECG values (12-lead reporting ventricular rate and PR, QRS, QT and QTc interval) at screening and baseline based on opinion of the investigator.\n * Immunizations (tetanus, diphtheria, pertussis, seasonal influenza [during flu season], and pneumococcal [polysaccharide] vaccinations) up to date per local standards as determined by the investigator.\n\n","\n\n * Class IV RA according to ACR revised response criteria\n * Diagnosis of Felty's Syndrome (RA, splenomegaly and granulocytopenia).\n * Prosthetic joint infection within 3 years of screening or native joint infection within 1 year prior to screening.\n * Active infection (including chronic or localized infections) for which anti-infectives were indicated within 4 weeks prior to day 1 OR presence of serious infection, defined as requiring hospitalization or intravenous anti-infectives within 8 weeks prior to day 1.\n * Known history of active tuberculosis.\n * Positive test for tuberculosis during screening defined as either: positive purified protein derivative (PPD) (â‰¥ 5 mm of induration at 48 to 72 hours after test is placed) OR positive Quantiferon test: a positive PPD and a history of Bacillus Calmette-GuÃ©rin vaccination are allowed with a negative Quantiferon test and negative chest x ray; a positive PPD test (without a history of Bacillus Calmette-GuÃ©rin vaccination) or a positive or indeterminate Quantiferon test are allowed if they have ALL of the following at screening: no symptoms per tuberculosis or sheet provided by Amgen; document history of a completed course of adequate prophylaxis(completed treatment for latent tuberculosis per local standard of care prior to the start of investigational product); no known exposure to a case of active tuberculosis after most recent prophylaxis; negative chest X-ray.\n * Positive for hepatitis B surface antigen, hepatitis B core antibody (confirmed by hepatitis B DNA polymerase chain reaction [PCR] test) or detectable hepatitis C virus RNA by PCR (screening is generally done by hepatitis C antibody [HepCAb], followed by hepatitis C virus RNA by PCR if HepCAb is positive). A history of hepatitis B vaccination without history of hepatitis B is allowed.\n * Phase 1b only: Positive for Human Immunodeficiency Virus (HIV) at screening or known to be HIV positive. Phase 2a only: Known history of HIV\n * Positive drug or alcohol urine test at screening.\n * Presence of one or more significant concurrent medical conditions per investigator judgment, including but not limited to the following: poorly controlled diabetes or hypertension; chronic kidney disease stage IIIb, IV, or V; symptomatic heart failure (New York Heart Association class II, III, or IV); myocardial infarction or unstable angina pectoris within the past 12 months prior to randomization; severe chronic pulmonary disease (eg, requiring oxygen therapy); multiple sclerosis or any other demyelinating disease; major chronic inflammatory disease or connective tissue disease other than RA (eg, systemic lupus erythematosus with the exception of secondary SjÃ¶gren's syndrome).\n * Malignancy except non-melanoma skin cancers, cervical or breast ductal carcinoma in situ within the last 5 years.\n * History of alcohol or substance abuse within 6 months of screening\n * Phase 1b only: Current smoker, and/or use of any nicotine or tobacco containing products within the last 6 months prior to day 1. These types of products include but are not limited to: snuff, chewing tobacco, cigars, electronic cigarettes, cigarettes, pipes, or nicotine patches.\n * Phase 1b only: Subject unwilling to limit alcohol consumption to â‰¤ 1 drink of alcohol per day and â‰¤ 3 drinks per week for the duration of the study, where a drink is equivalent to 12 ounces of regular beer, 8 to 9 ounces of malt liquor, 5 ounces of wine, or 1.5 ounces of 80 proof distilled spirits. Phase 1b only: Unwilling or unable to abstain from alcohol consumption within 48 hours prior to each visit (including screening).\n * Subjects who have received intra-articular or systemic corticosteroid injections for treatment of acute RA flare (not being part of a regular therapeutic regimen) within 4 weeks prior to screening.\n * Currently receiving or had treatment with cyclophosphamide, chlorambucil, nitrogen mustard, or any other alkylating agent â‰¤ 6 months prior to day 1.\n * Prior treatment with more than a total of 3 therapies that include biologic DMARDs or oral synthetic DMARDs (such as tofacinitib, baricitinib). Prior treatment consists of at least 4 doses of a given therapy where the doses were given solely for treatment of RA disease. Prior therapies must not have been used within the following time periods: * â‰¤ 4 weeks prior to day 1 for etanercept and anakinra\n    * â‰¤ 6 months for rituximab\n    * â‰¤ 2 weeks for oral janus kinase inhibitors\n    * â‰¤ 9 weeks prior to day 1 for all therapies not listed above\n   \n   \n * Currently receiving or had treatment with any of the following â‰¤ 12 weeks prior to day 1: * azathioprine\n    * cyclosporine\n    * gold\n    * mycophenolate mofetil\n    * Prosorba column\n    * Tacrolimus\n   \n   \n * Phase 2a only: Currently receiving or had treatment with leflunomide â‰¤ 12 weeks prior to day 1 unless an active washout with cholestyramine has been performed.\n * Phase 2a only: Currently receiving or had treatment with any of the following â‰¤ 4 weeks prior to day 1: * hydroxychloroquine\n    * sulfasalazine\n    * minocycline\n    * oral janus kinase inhibitor (eg, tofacitinib, baricitinib)\n    * intra-articular, intramuscular or intravenous corticosteroids, including adrenocorticotropic hormone\n    * intra-articular hyaluronic acid injections\n    * live vaccines\n   \n   \n * Unstable dose of non-steroidal anti-inflammatory drugs (NSAID), acetaminophen, and/or analgesics which is taken on an unscheduled basis (ie, not daily or scheduled every certain number of hours) and/or initiated <4 weeks prior to day 1.\n * Received the following within 12 hours prior to screening or day 1:\n\nacetaminophen, NSAIDs, tramadol, and/or any narcotic analgesics such as but not limited to hydrocodone, codeine, tramadol, propoxyphene and/or oxycodone (unless in the form of oxycontin). Subject has taken oxycontin within 24 hours prior to screening or day 1.\n\n * Phase 1b only: Received any herbal medicines (eg St John's wort),or non-vitamin dietary supplements (eg, magnesium) with the exception of calcium within 4 weeks prior to day 1.\n * Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded.\n * Presence of laboratory abnormalities at screening including the following: * Aspartate aminotransferase (AST) or alanine amino transferase (ALT) at screening > 1.5X upper limit of normal (ULN)\n    * Serum total bilirubin (TBL) â‰¥ 1.5 mg/dL (â‰¥ 26 Î¼mol/L)\n    * Hemoglobin â‰¤ 10.5 g/dL(â‰¤105 g/L)\n    * Platelet count < 100,000/mm3 (<100 x 109/L)\n    * White blood cell count < 3,000 cells/mm3 (3.0 x 109/L)\n    * Absolute neutrophil count (ANC) < 1,500/mm3 (1.5 x 109/L)\n    * Calculated glomerular filtration rate of â‰¤ 50 mL/min/1.73 m2 using the Modification of Diet in Renal Disease (MDRD) formula\n   \n   \n * Any other laboratory abnormality, which, in the opinion of the investigator, poses a safety risk, will prevent the subject from completing the study, will interfere with the interpretation of the study results, or might cause the study to be detrimental to the subject.\n * Female subject is pregnant or breastfeeding or planning to become pregnant or breastfeed during treatment and for an additional 6 weeks after the last dose of investigational product.\n * Females of child-bearing potential with a positive pregnancy test (assessed by a serum pregnancy test at screening and a urine pregnancy test at baseline).\n * Female subjects of childbearing potential unwilling to use 1 highly effective method of contraception during treatment and for an additional 6 weeks after the last dose of investigational product. Refer to Appendix 5 for additional contraceptive information.\n * Subject has known sensitivity to any of the products or components to be administered during dosing.\n * Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures (eg, Clinical Outcome Assessments [COAs]) to the best of the subject and investigator's knowledge.\n * History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion","CRP","C-reactive protein","Protein","Breast","Actual","2018-01-25","Actual","Anticipated","2020-10-18","Anticipated","2018-10-01","2018-01-03","2018-01-18","2018-10-18","No",null,"Interventional","Treatment","Sequential Assignment","Double (Participant, Investigator)","Randomized","18 Years","70 Years","All",null,"Yes","Yes\nDe-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.",null,"URL: http://www.amgentrials.com [http://www.amgentrials.com] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: AmgenTrials clinical trials website",null,"Yes","No",{"$nulls":17},"2017â€\u0090001944â€\u009036","EudraCT Number","ACR 20","The primary endpoint, ACR 20 at week 12, will be assessed between AMG 592 and placebo in the 2 populations respectively.","Week 12","ACR 50/70|DAS28-ESR|DAS 28-CRP|Maximum observed concentration (Cmax) of AMG592|Time of maximum observed concentration (Tmax) of AMG592|Area under the concentration-time curve (AUCtau) of AMG592","Evaluate the effect of treatment with AMG592 on ACR 50/70 change from baseline at week 12.|Evaluate the effect of treatment with AMG on disease activity score (28 joint) calculated using the erythrocyte sedimentation rate formula (DAS28-ESR) score and change from baseline at week 12.|Evaluate the effect of treatment with AMG on disease activity score (28 joint) calculated using the c-reactive protein formula (DAS 28-CRP) score and change from baseline at week 12.|Analyze serum concentrations of AMG592","Week 12","medinfo@amgen.com","Amgen Call Center","866-572-6436","Sofia, Bulgaria, 1612|Berlin, Germany, 10117 Research SiteFrankfurt Am Main, Germany, 60590|Krakow, Poland, 30-348 Research SitePoznan, Poland, 60-848 Research SiteStalowa Wola, Poland, 37-450 Research SiteSwidnik, Poland, 21-040 Research SiteWarszawa, Poland, 02-797 Research SiteWroclaw, Poland, 51-128|A CoruÃ±a, Galicia, Spain, 15006|Anniston, Alabama, United States, 36207|Torrance, California, United States, 90502|Lansing, Michigan, United States, 48910|Dallas, Texas, United States, 75231","Alabama|California|Michigan|Texas","Bulgaria|Germany|Poland|Spain|United States","Research Site|Galicia Research Site",{"$nulls":3},"MD","2018-10-18","2020-05-25T16:38:36.927","2020-05-26T17:10:42.972","NCT03410056"]
["5ecbf48d307e3d1b1f8d9dd1","NCT03410056","2019-10-17","Amgen","AMGN","Recruiting","Safety and Efficacy of AMG 592 in Subjects With Active Rheumatoid Arthritis","Efavaleukin alfa","IL2 Inhibitor","Yes","['Efavaleukin alfa']","No",null,"Phase 1/Phase 2",2,153,"Anticipated","2018-05-22","2021-12-03",{"$nulls":5},"Phase 1b. To evaluate the safety and tolerability of subcutaneous (SC)dose administrations of AMG 592 in subjects with active RA.\n\nPhase 2a. To evaluate the efficacy of AMG 592 at week 12 as measured by the American College of Rheumatology 20% improvement criteria (ACR 20) in adult subjects with moderate to severe RA.",null,"A Phase 1b/2a Study to Evaluate the Safety and Efficacy of AMG 592 in Subjects With Active Rheumatoid Arthritis With Inadequate Response to Standard of Care Therapy",20170149,"Rheumatoid Arthritis RA","Arthritis|Arthritis, Rheumatoid","Joint Diseases","Musculoskeletal","Experimental|Placebo Comparator","AMG 592|Placebo","The phase 1b part of the study is a double-blind, placebo controlled, MAD study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of AMG 592 in subjects with active RA. The phase 2a part of the study will commence after a RP2D is identified in the phase 1b part of the study.","Drug","AMG 592|Placebo","AMG 592|Placebo",null,"AMG 592|Placebo","\n\n * Subject has provided informed consent prior to initiation of any study specific activities/procedures.\n * Age â‰¥ 18 to â‰¤ 70 years of age at screening.\n * A diagnosis of RA consistent with the 1987 or 2010 American College of Rheumatology (ACR)/European League Against Rheumatism classification criteria.\n * Active RA defined as: Phase 1b: DAS-28-CRP > 2.6 at screening. The 28-joint count consists of the finger joints excluding the distal interphalangeal joints, the wrists, elbows, shoulders, and knees. Phase 2a: â‰¥ 6 swollen joints (based on 66-joint count) and â‰¥ 6 tender joints (based on 68-joint count) at screening and baseline. The distal interphalangeal joint should be evaluated but not included in the total count to determine eligibility. Additionally, C-reactive protein (CRP) must be greater than the upper limit of normal (ULN) per the central laboratory at screening.\n * Receiving treatment with methotrexate for â‰¥ 12 weeks and on a stable dose â‰¥ 15 mg weekly for â‰¥ 8 weeks prior to day 1. A lower methotrexate dose is acceptable (but no lower than 10 mg weekly) if it is the highest tolerated dose and gastrointestinal or hematologic toxicity at doses â‰¥ 15 mg weekly is documented by the investigator.\n * Receiving treatment with folic or folinic acid per investigator judgment or according to local standard of care.\n * Phase 1b only: Subject may be receiving a stable dose of leflunomide, sulfasalazine, hydroxychloroquine, minocycline in combination with methotrexate and the dose must be stable for â‰¥ 8 weeks prior to day 1.\n * Subject may be receiving a stable dose of prednisone â‰¤ 10mg daily or other equivalent corticosteroid dose and the dose must be stable for â‰¥ 2 weeks prior today 1.\n * Phase 1b only. Normal or clinically acceptable ECG values (12-lead reporting ventricular rate and PR, QRS, QT and QTc interval) at screening and baseline based on opinion of the investigator.\n * Immunizations (tetanus, diphtheria, pertussis, seasonal influenza [during flu season], and pneumococcal [polysaccharide] vaccinations) up to date per local standards as determined by the investigator.\n\n","\n\n * Class IV RA according to ACR revised response criteria\n * Diagnosis of Felty's Syndrome (RA, splenomegaly and granulocytopenia).\n * Prosthetic joint infection within 3 years of screening or native joint infection within 1 year prior to screening.\n * Active infection (including chronic or localized infections) for which anti-infectives were indicated within 4 weeks prior to day 1 OR presence of serious infection, defined as requiring hospitalization or intravenous anti-infectives within 8 weeks prior to day 1.\n * Known history of active tuberculosis.\n * Positive test for tuberculosis during screening defined as either: positive purified protein derivative (PPD) (â‰¥ 5 mm of induration at 48 to 72 hours after test is placed) OR positive Quantiferon test: a positive PPD and a history of Bacillus Calmette-GuÃ©rin vaccination are allowed with a negative Quantiferon test and negative chest x ray; a positive PPD test (without a history of Bacillus Calmette-GuÃ©rin vaccination) or a positive or indeterminate Quantiferon test are allowed if they have ALL of the following at screening: no symptoms per tuberculosis or sheet provided by Amgen; document history of a completed course of adequate prophylaxis(completed treatment for latent tuberculosis per local standard of care prior to the start of investigational product); no known exposure to a case of active tuberculosis after most recent prophylaxis; negative chest X-ray.\n * Positive for hepatitis B surface antigen, hepatitis B core antibody (confirmed by hepatitis B DNA polymerase chain reaction [PCR] test) or detectable hepatitis C virus RNA by PCR (screening is generally done by hepatitis C antibody [HepCAb], followed by hepatitis C virus RNA by PCR if HepCAb is positive). A history of hepatitis B vaccination without history of hepatitis B is allowed.\n * Phase 1b only: Positive for Human Immunodeficiency Virus (HIV) at screening or known to be HIV positive. Phase 2a only: Known history of HIV\n * Phase 1b only: Positive drug or alcohol urine test for illicit drugs at screening. Prescription medications detected by the drug test are allowed if they are being taken under the direction of a physician.\n * Presence of one or more significant concurrent medical conditions per investigator judgment, including but not limited to the following: poorly controlled diabetes or hypertension; chronic kidney disease stage IIIb, IV, or V; symptomatic heart failure (New York Heart Association class II, III, or IV); myocardial infarction or unstable angina pectoris within the past 12 months prior to randomization; severe chronic pulmonary disease (eg, requiring oxygen therapy); multiple sclerosis or any other demyelinating disease; major chronic inflammatory disease or connective tissue disease other than RA (eg, systemic lupus erythematosus with the exception of secondary SjÃ¶gren's syndrome).\n * Malignancy except non-melanoma skin cancers, cervical or breast ductal carcinoma in situ within the last 5 years.\n * History of alcohol or substance abuse within 6 months of screening\n * Phase 1b only: Current smoker, and/or use of any nicotine or tobacco containing products within the last 6 months prior to day 1. These types of products include but are not limited to: snuff, chewing tobacco, cigars, electronic cigarettes, cigarettes, pipes, or nicotine patches.\n * Phase 1b only: Subject unwilling to limit alcohol consumption to â‰¤ 1 drink of alcohol per day and â‰¤ 3 drinks per week for the duration of the study, where a drink is equivalent to 12 ounces of regular beer, 8 to 9 ounces of malt liquor, 5 ounces of wine, or 1.5 ounces of 80 proof distilled spirits. Phase 1b only: Unwilling or unable to abstain from alcohol consumption within 48 hours prior to each visit (including screening).\n * Subjects who have received intra-articular or systemic corticosteroid injections for treatment of acute RA flare (not being part of a regular therapeutic regimen) within 4 weeks prior to screening.\n * Currently receiving or had treatment with cyclophosphamide, chlorambucil, nitrogen mustard, or any other alkylating agent â‰¤ 6 months prior to day 1.\n * Prior treatment with more than a total of 3 therapies that include biologic DMARDs or oral synthetic DMARDs (such as tofacinitib, baricitinib). Prior treatment consists of at least 4 doses of a given therapy where the doses were given solely for treatment of RA disease. Prior therapies must not have been used within the following time periods: * â‰¤ 4 weeks prior to day 1 for etanercept and anakinra\n    * â‰¤ 6 months for rituximab\n    * â‰¤ 2 weeks for oral janus kinase inhibitors\n    * â‰¤ 9 weeks prior to day 1 for all therapies not listed above\n   \n   \n * Currently receiving or had treatment with any of the following â‰¤ 12 weeks prior to day 1: * azathioprine\n    * cyclosporine\n    * gold\n    * mycophenolate mofetil\n    * Prosorba column\n    * Tacrolimus\n   \n   \n * Phase 2a only: Currently receiving or had treatment with leflunomide â‰¤ 12 weeks prior to day 1 unless an active washout with cholestyramine has been performed.\n * Phase 2a only: Currently receiving or had treatment with any of the following â‰¤ 4 weeks prior to day 1: * hydroxychloroquine\n    * sulfasalazine\n    * minocycline\n    * oral janus kinase inhibitor (eg, tofacitinib, baricitinib)\n    * intra-articular, intramuscular or intravenous corticosteroids, including adrenocorticotropic hormone\n    * intra-articular hyaluronic acid injections\n    * live vaccines\n   \n   \n * Unstable dose of non-steroidal anti-inflammatory drugs (NSAID), acetaminophen, and/or analgesics which is taken on an unscheduled basis (ie, not daily or scheduled every certain number of hours) and/or initiated <4 weeks prior to day 1.\n * Received the following within 12 hours prior to screening or day 1:\n\nacetaminophen, NSAIDs, tramadol, and/or any narcotic analgesics such as but not limited to hydrocodone, codeine, tramadol, propoxyphene and/or oxycodone (unless in the form of oxycontin). Subject has taken oxycontin within 24 hours prior to screening or day 1.\n\n * Phase 1b only: Received any herbal medicines (eg St John's wort),or non-vitamin dietary supplements (eg, magnesium) with the exception of calcium within 4 weeks prior to day 1.\n * Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded.\n * Presence of laboratory abnormalities at screening including the following: * Aspartate aminotransferase (AST) or alanine amino transferase (ALT) at screening > 1.5X upper limit of normal (ULN)\n    * Serum total bilirubin (TBL) â‰¥ 1.5 mg/dL (â‰¥ 26 Î¼mol/L)\n    * Hemoglobin â‰¤ 10.5 g/dL(â‰¤105 g/L)\n    * Platelet count < 100,000/mm3 (<100 x 109/L)\n    * White blood cell count < 2,500 cells/mm3 (2.5 x 109/L)\n    * Absolute neutrophil count (ANC) < 1,000/mm3 (1.0 x 109/L)\n    * Calculated glomerular filtration rate of â‰¤ 50 mL/min/1.73 m2 using the Modification of Diet in Renal Disease (MDRD) formula\n   \n   \n * Any other laboratory abnormality, which, in the opinion of the investigator, poses a safety risk, will prevent the subject from completing the study, will interfere with the interpretation of the study results, or might cause the study to be detrimental to the subject.\n * Female subject is pregnant or breastfeeding or planning to become pregnant or breastfeed during treatment and for an additional 6 weeks after the last dose of investigational product.\n * Females of child-bearing potential with a positive pregnancy test (assessed by a serum pregnancy test at screening and a urine pregnancy test at baseline).\n * Female subjects of childbearing potential unwilling to use 1 highly effective method of contraception during treatment and for an additional 6 weeks after the last dose of investigational product. Refer to Appendix 5 for additional contraceptive information.\n * Subject has known sensitivity to any of the products or components to be administered during dosing.\n * Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures (eg, Clinical Outcome Assessments [COAs]) to the best of the subject and investigator's knowledge.\n * History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion","CRP","C-reactive protein","Protein","Breast","Actual","2018-01-25","Actual","Anticipated","2022-09-09","Anticipated","2019-10-01","2018-01-03","2018-01-18","2019-10-16","No",null,"Interventional","Treatment","Sequential Assignment","Double (Participant, Investigator)","Randomized","18 Years","70 Years","All",null,"Yes","Yes\nDe-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.",null,"URL: http://www.amgentrials.com [http://www.amgentrials.com] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: AmgenTrials clinical trials website",null,"Yes","No",{"$nulls":17},"2017â€\u0090001944â€\u009036","EudraCT Number","ACR 20","The primary endpoint, ACR 20 at week 12, will be assessed between AMG 592 and placebo in the 2 populations respectively.","Week 12","ACR 50/70|DAS28-ESR|DAS 28-CRP|Maximum observed concentration (Cmax) of AMG592|Time of maximum observed concentration (Tmax) of AMG592|Area under the concentration-time curve (AUCtau) of AMG592","Evaluate the effect of treatment with AMG592 on ACR 50/70 change from baseline at week 12.|Evaluate the effect of treatment with AMG on disease activity score (28 joint) calculated using the erythrocyte sedimentation rate formula (DAS28-ESR) score and change from baseline at week 12.|Evaluate the effect of treatment with AMG on disease activity score (28 joint) calculated using the c-reactive protein formula (DAS 28-CRP) score and change from baseline at week 12.|Analyze serum concentrations of AMG592","Week 12","medinfo@amgen.com","Amgen Call Center","866-572-6436","Sofia, Bulgaria, 1612|Berlin, Germany, 10117 Research SiteFrankfurt Am Main, Germany, 60590|Jozefow, Poland, 05-410 Research SiteKrakow, Poland, 30-348 Research SitePoznan, Poland, 60-848 Research SiteStalowa Wola, Poland, 37-450 Research SiteSwidnik, Poland, 21-040 Research SiteWroclaw, Poland, 51-128|A CoruÃ±a, Galicia, Spain, 15006|Anniston, Alabama, United States, 36207|Torrance, California, United States, 90502|Lansing, Michigan, United States, 48910|Duncansville, Pennsylvania, United States, 16635|Dallas, Texas, United States, 75231","Alabama|California|Michigan|Pennsylvania|Texas","Bulgaria|Germany|Poland|Spain|United States","Research Site|Galicia Research Site",{"$nulls":3},"MD","2019-10-16","2020-05-25T16:38:37.130","2020-05-26T17:10:42.972","NCT03410056"]
["5ecbf48d11702c1b1b916b4e","NCT03410056","2019-10-25","Amgen","AMGN","Active, not recruiting","Safety and Efficacy of AMG 592 in Subjects With Active Rheumatoid Arthritis","Efavaleukin alfa","IL2 Inhibitor","Yes","['Efavaleukin alfa']","No",null,"Phase 1/Phase 2",2,153,"Anticipated","2018-05-22","2020-01-28",{"$nulls":5},"Phase 1b. To evaluate the safety and tolerability of subcutaneous (SC)dose administrations of AMG 592 in subjects with active RA.\n\nPhase 2a. To evaluate the efficacy of AMG 592 at week 12 as measured by the American College of Rheumatology 20% improvement criteria (ACR 20) in adult subjects with moderate to severe RA.",null,"A Phase 1b/2a Study to Evaluate the Safety and Efficacy of AMG 592 in Subjects With Active Rheumatoid Arthritis With Inadequate Response to Standard of Care Therapy",20170149,"Rheumatoid Arthritis RA","Arthritis|Arthritis, Rheumatoid","Joint Diseases","Musculoskeletal","Experimental|Placebo Comparator","AMG 592|Placebo","The phase 1b part of the study is a double-blind, placebo controlled, MAD study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of AMG 592 in subjects with active RA. The phase 2a part of the study will commence after a RP2D is identified in the phase 1b part of the study.","Drug","AMG 592|Placebo","AMG 592|Placebo",null,"AMG 592|Placebo","\n\n * Subject has provided informed consent prior to initiation of any study specific activities/procedures.\n * Age â‰¥ 18 to â‰¤ 70 years of age at screening.\n * A diagnosis of RA consistent with the 1987 or 2010 American College of Rheumatology (ACR)/European League Against Rheumatism classification criteria.\n * Active RA defined as: Phase 1b: DAS-28-CRP > 2.6 at screening. The 28-joint count consists of the finger joints excluding the distal interphalangeal joints, the wrists, elbows, shoulders, and knees. Phase 2a: â‰¥ 6 swollen joints (based on 66-joint count) and â‰¥ 6 tender joints (based on 68-joint count) at screening and baseline. The distal interphalangeal joint should be evaluated but not included in the total count to determine eligibility. Additionally, C-reactive protein (CRP) must be greater than the upper limit of normal (ULN) per the central laboratory at screening.\n * Receiving treatment with methotrexate for â‰¥ 12 weeks and on a stable dose â‰¥ 15 mg weekly for â‰¥ 8 weeks prior to day 1. A lower methotrexate dose is acceptable (but no lower than 10 mg weekly) if it is the highest tolerated dose and gastrointestinal or hematologic toxicity at doses â‰¥ 15 mg weekly is documented by the investigator.\n * Receiving treatment with folic or folinic acid per investigator judgment or according to local standard of care.\n * Phase 1b only: Subject may be receiving a stable dose of leflunomide, sulfasalazine, hydroxychloroquine, minocycline in combination with methotrexate and the dose must be stable for â‰¥ 8 weeks prior to day 1.\n * Subject may be receiving a stable dose of prednisone â‰¤ 10mg daily or other equivalent corticosteroid dose and the dose must be stable for â‰¥ 2 weeks prior today 1.\n * Phase 1b only. Normal or clinically acceptable ECG values (12-lead reporting ventricular rate and PR, QRS, QT and QTc interval) at screening and baseline based on opinion of the investigator.\n * Immunizations (tetanus, diphtheria, pertussis, seasonal influenza [during flu season], and pneumococcal [polysaccharide] vaccinations) up to date per local standards as determined by the investigator.\n\n","\n\n * Class IV RA according to ACR revised response criteria\n * Diagnosis of Felty's Syndrome (RA, splenomegaly and granulocytopenia).\n * Prosthetic joint infection within 3 years of screening or native joint infection within 1 year prior to screening.\n * Active infection (including chronic or localized infections) for which anti-infectives were indicated within 4 weeks prior to day 1 OR presence of serious infection, defined as requiring hospitalization or intravenous anti-infectives within 8 weeks prior to day 1.\n * Known history of active tuberculosis.\n * Positive test for tuberculosis during screening defined as either: positive purified protein derivative (PPD) (â‰¥ 5 mm of induration at 48 to 72 hours after test is placed) OR positive Quantiferon test: a positive PPD and a history of Bacillus Calmette-GuÃ©rin vaccination are allowed with a negative Quantiferon test and negative chest x ray; a positive PPD test (without a history of Bacillus Calmette-GuÃ©rin vaccination) or a positive or indeterminate Quantiferon test are allowed if they have ALL of the following at screening: no symptoms per tuberculosis or sheet provided by Amgen; document history of a completed course of adequate prophylaxis(completed treatment for latent tuberculosis per local standard of care prior to the start of investigational product); no known exposure to a case of active tuberculosis after most recent prophylaxis; negative chest X-ray.\n * Positive for hepatitis B surface antigen, hepatitis B core antibody (confirmed by hepatitis B DNA polymerase chain reaction [PCR] test) or detectable hepatitis C virus RNA by PCR (screening is generally done by hepatitis C antibody [HepCAb], followed by hepatitis C virus RNA by PCR if HepCAb is positive). A history of hepatitis B vaccination without history of hepatitis B is allowed.\n * Phase 1b only: Positive for Human Immunodeficiency Virus (HIV) at screening or known to be HIV positive. Phase 2a only: Known history of HIV\n * Phase 1b only: Positive drug or alcohol urine test for illicit drugs at screening. Prescription medications detected by the drug test are allowed if they are being taken under the direction of a physician.\n * Presence of one or more significant concurrent medical conditions per investigator judgment, including but not limited to the following: poorly controlled diabetes or hypertension; chronic kidney disease stage IIIb, IV, or V; symptomatic heart failure (New York Heart Association class II, III, or IV); myocardial infarction or unstable angina pectoris within the past 12 months prior to randomization; severe chronic pulmonary disease (eg, requiring oxygen therapy); multiple sclerosis or any other demyelinating disease; major chronic inflammatory disease or connective tissue disease other than RA (eg, systemic lupus erythematosus with the exception of secondary SjÃ¶gren's syndrome).\n * Malignancy except non-melanoma skin cancers, cervical or breast ductal carcinoma in situ within the last 5 years.\n * History of alcohol or substance abuse within 6 months of screening\n * Phase 1b only: Current smoker, and/or use of any nicotine or tobacco containing products within the last 6 months prior to day 1. These types of products include but are not limited to: snuff, chewing tobacco, cigars, electronic cigarettes, cigarettes, pipes, or nicotine patches.\n * Phase 1b only: Subject unwilling to limit alcohol consumption to â‰¤ 1 drink of alcohol per day and â‰¤ 3 drinks per week for the duration of the study, where a drink is equivalent to 12 ounces of regular beer, 8 to 9 ounces of malt liquor, 5 ounces of wine, or 1.5 ounces of 80 proof distilled spirits. Phase 1b only: Unwilling or unable to abstain from alcohol consumption within 48 hours prior to each visit (including screening).\n * Subjects who have received intra-articular or systemic corticosteroid injections for treatment of acute RA flare (not being part of a regular therapeutic regimen) within 4 weeks prior to screening.\n * Currently receiving or had treatment with cyclophosphamide, chlorambucil, nitrogen mustard, or any other alkylating agent â‰¤ 6 months prior to day 1.\n * Prior treatment with more than a total of 3 therapies that include biologic DMARDs or oral synthetic DMARDs (such as tofacinitib, baricitinib). Prior treatment consists of at least 4 doses of a given therapy where the doses were given solely for treatment of RA disease. Prior therapies must not have been used within the following time periods: * â‰¤ 4 weeks prior to day 1 for etanercept and anakinra\n    * â‰¤ 6 months for rituximab\n    * â‰¤ 2 weeks for oral janus kinase inhibitors\n    * â‰¤ 9 weeks prior to day 1 for all therapies not listed above\n   \n   \n * Currently receiving or had treatment with any of the following â‰¤ 12 weeks prior to day 1: * azathioprine\n    * cyclosporine\n    * gold\n    * mycophenolate mofetil\n    * Prosorba column\n    * Tacrolimus\n   \n   \n * Phase 2a only: Currently receiving or had treatment with leflunomide â‰¤ 12 weeks prior to day 1 unless an active washout with cholestyramine has been performed.\n * Phase 2a only: Currently receiving or had treatment with any of the following â‰¤ 4 weeks prior to day 1: * hydroxychloroquine\n    * sulfasalazine\n    * minocycline\n    * oral janus kinase inhibitor (eg, tofacitinib, baricitinib)\n    * intra-articular, intramuscular or intravenous corticosteroids, including adrenocorticotropic hormone\n    * intra-articular hyaluronic acid injections\n    * live vaccines\n   \n   \n * Unstable dose of non-steroidal anti-inflammatory drugs (NSAID), acetaminophen, and/or analgesics which is taken on an unscheduled basis (ie, not daily or scheduled every certain number of hours) and/or initiated <4 weeks prior to day 1.\n * Received the following within 12 hours prior to screening or day 1:\n\nacetaminophen, NSAIDs, tramadol, and/or any narcotic analgesics such as but not limited to hydrocodone, codeine, tramadol, propoxyphene and/or oxycodone (unless in the form of oxycontin). Subject has taken oxycontin within 24 hours prior to screening or day 1.\n\n * Phase 1b only: Received any herbal medicines (eg St John's wort),or non-vitamin dietary supplements (eg, magnesium) with the exception of calcium within 4 weeks prior to day 1.\n * Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded.\n * Presence of laboratory abnormalities at screening including the following: * Aspartate aminotransferase (AST) or alanine amino transferase (ALT) at screening > 1.5X upper limit of normal (ULN)\n    * Serum total bilirubin (TBL) â‰¥ 1.5 mg/dL (â‰¥ 26 Î¼mol/L)\n    * Hemoglobin â‰¤ 10.5 g/dL(â‰¤105 g/L)\n    * Platelet count < 100,000/mm3 (<100 x 109/L)\n    * White blood cell count < 2,500 cells/mm3 (2.5 x 109/L)\n    * Absolute neutrophil count (ANC) < 1,000/mm3 (1.0 x 109/L)\n    * Calculated glomerular filtration rate of â‰¤ 50 mL/min/1.73 m2 using the Modification of Diet in Renal Disease (MDRD) formula\n   \n   \n * Any other laboratory abnormality, which, in the opinion of the investigator, poses a safety risk, will prevent the subject from completing the study, will interfere with the interpretation of the study results, or might cause the study to be detrimental to the subject.\n * Female subject is pregnant or breastfeeding or planning to become pregnant or breastfeed during treatment and for an additional 6 weeks after the last dose of investigational product.\n * Females of child-bearing potential with a positive pregnancy test (assessed by a serum pregnancy test at screening and a urine pregnancy test at baseline).\n * Female subjects of childbearing potential unwilling to use 1 highly effective method of contraception during treatment and for an additional 6 weeks after the last dose of investigational product. Refer to Appendix 5 for additional contraceptive information.\n * Subject has known sensitivity to any of the products or components to be administered during dosing.\n * Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures (eg, Clinical Outcome Assessments [COAs]) to the best of the subject and investigator's knowledge.\n * History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion","CRP","C-reactive protein","Protein","Breast","Actual","2018-01-25","Actual","Anticipated","2022-09-09","Anticipated","2019-10-01","2018-01-03","2018-01-18","2019-10-24","No",null,"Interventional","Treatment","Sequential Assignment","Double (Participant, Investigator)","Randomized","18 Years","70 Years","All",null,"Yes","Yes\nDe-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.",null,"URL: http://www.amgentrials.com [http://www.amgentrials.com] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: AmgenTrials clinical trials website",null,"Yes","No",{"$nulls":17},"2017â€\u0090001944â€\u009036","EudraCT Number","ACR 20","The primary endpoint, ACR 20 at week 12, will be assessed between AMG 592 and placebo in the 2 populations respectively.","Week 12","ACR 50/70|DAS28-ESR|DAS 28-CRP|Maximum observed concentration (Cmax) of AMG592|Time of maximum observed concentration (Tmax) of AMG592|Area under the concentration-time curve (AUCtau) of AMG592","Evaluate the effect of treatment with AMG592 on ACR 50/70 change from baseline at week 12.|Evaluate the effect of treatment with AMG on disease activity score (28 joint) calculated using the erythrocyte sedimentation rate formula (DAS28-ESR) score and change from baseline at week 12.|Evaluate the effect of treatment with AMG on disease activity score (28 joint) calculated using the c-reactive protein formula (DAS 28-CRP) score and change from baseline at week 12.|Analyze serum concentrations of AMG592","Week 12",{"$nulls":3},"Sofia, Bulgaria, 1612|Berlin, Germany, 10117 Research SiteFrankfurt Am Main, Germany, 60590|Jozefow, Poland, 05-410 Research SiteKrakow, Poland, 30-348 Research SitePoznan, Poland, 60-848 Research SiteStalowa Wola, Poland, 37-450 Research SiteSwidnik, Poland, 21-040 Research SiteWroclaw, Poland, 51-128|A CoruÃ±a, Galicia, Spain, 15006|Anniston, Alabama, United States, 36207|Torrance, California, United States, 90502|Lansing, Michigan, United States, 48910|Duncansville, Pennsylvania, United States, 16635|Dallas, Texas, United States, 75231","Alabama|California|Michigan|Pennsylvania|Texas","Bulgaria|Germany|Poland|Spain|United States","Research Site|Galicia Research Site",{"$nulls":3},"MD","2019-10-24","2020-05-25T16:38:37.162","2020-05-26T17:10:42.972","NCT03410056"]
["5ecbf48d307e3d1b1f8d9dd2","NCT03410108","2018-03-30","Takeda","TAK","Recruiting","Phase 2 Study of Brigatinib in Japanese Patients With ALK-Positive Non-Small Cell Lung Cancer (NSCLC)","Brigatinib","TK Inhibitor|ALK Inhibitor","No",null,"No",null,"Phase 2",1,80,"Anticipated","2018-01-17","2019-12-31","RR","Response Rate",{"$nulls":3},"The purpose of this study is to evaluate efficacy and safety of Brigatinib in Japanese patients with anaplastic lymphoma kinase (ALK)-positive NSCLC that has progressed after 1 or 2 lines of prior ALK inhibitor therapy.","The drug being tested in this study is called brigatinib. Brigatinib is being tested in patients with ALK-positive NSCLC in order to evaluate efficacy and safety of oral doses of brigatinib in Japanese patients with ALK-positive NSCLC.\n\nThe study will enroll approximately 80 participants. Participants will be enrolled in non-randomized and opened manner:\n\n- Brigatinib 90 mg for the first 7 days, followed by Brigatinib 180 mg of Brigatinib tablets, once daily in a 28-days cycle.\n\nAll participants will be asked to take tablets of brigatinib once daily with or without food throughout the study.\n\nThis multi-center trial will be conducted in Japan. The overall time to participate in this study is approximately 41 months. Participants will make multiple visits to the clinic during the treatment period, and posttreatment period including a follow-up assessment after last dose of study drug.","A Single-Arm, Multicenter, Phase 2 Study of Brigatinib in Japanese Patients With ALK-Positive Non-Small Cell Lung Cancer (NSCLC)","Brigatinib-2001","ALK-positive Advanced NSCLC","Non-Small-Cell Lung Cancer","Oncology Solid Tumor","Oncology","Experimental","Brigatinib 90 mg + Brigatinib 180 mg","90 mg of Brigatinib tablets, once daily for 7 days, followed by 180 mg of Brigatinib tablets, once daily in a 28-days cycle.","Drug","Brigatinib","Brigatinib tablet",null,"Brigatinib 90 mg + Brigatinib 180 mg","\n\n 1.  Male or female Japanese patients aged >=20 years on the day of consent.\n 2.  Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.\n 3.  Have histologically or cytologically confirmed stage IIIB, stage IIIC (locally advanced or recurrent and not a candidate for definitive multimodality therapy), or stage IV NSCLC.\n 4.  Must meet 1 of the following 2 criteria: 1. Have documentation of ALK rearrangement by a positive result from the Vysis ALK Break Apart FISH [fluorescence in situ hybridization] Probe Kit, the Nichirei Histofine ALK iAEP Kit, or the Ventana ALK (D5F3) CDx Assay at any time during prior disease course.\n      2. Had a documented ALK rearrangement by a different test at any time during prior disease course, and adequate tissue available for central laboratory testing by the Vysis ALK Break Apart FISH test. Central confirmation of ALK rearrangement is not required before enrollment.\n     \n     \n 5.  The expansion part only: had documented progressive disease (PD) during treatment or within 30 days after treatment with ALK inhibitor. * Note 1: The expansion part consists of the main cohort and a subcohort based on prior ALK inhibitor treatment. The main cohort includes patients who had previously received alectinib (as their only ALK inhibitor) or both crizotinib and alectinib (regardless the sequence of those 2 ALK inhibitors), and a total of 47 patients will be enrolled. Patients with all other sequences of up to 2 prior ALK inhibitor(s) may be included in the subcohort, and the number of patients will be limited to 20.\n      * Note 2: Patients who will be included in the main cohort should have documented PD during treatment or within 30 days after treatment with alectinib.\n     \n     \n 6.  Have at least 1 measurable (ie, target) lesion per RECIST version 1.1. Note: Previously irradiated lesions may not be used for target lesions, unless there is unambiguous radiological progression after radiotherapy. Brain lesions may not be used as target lesions if they were 1) previously treated with whole brain radiation therapy (WBRT) within 3 months, or 2) previously treated by stereotactic radiosurgery (SRS) or surgical resection.\n 7.  Recovered from toxicities related to prior anticancer therapy to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03 Grade =<1. Note: Treatment-related alopecia is allowed.\n 8.  Have a life expectancy of >=3 months.\n 9.  Have adequate organ and hematologic function, as determined by: 1. Both alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =<2.5 times the upper limit of the normal range (ULN) (=<5Ã—ULN is acceptable if liver metastases are present).\n      2. Total serum bilirubin =<1.5Ã—ULN (<3.0Ã—ULN for patients with Gilbert syndrome).\n      3. Serum creatinine <1.5Ã—ULN. For patients with creatinine levels above or equal to 1.5Ã—ULN, the patient is eligible if the estimated creatinine clearance using the Cockcroft-Gault formula is â‰¥30 mL/minute.\n      4. Serum lipase =<1.5Ã—ULN and serum amylase =<1.5Ã—ULN.\n      5. Absolute neutrophil count (ANC) >=1.5Ã—10^9/L.\n      6. Platelet count >=75Ã—10^9/L.\n      7. Hemoglobin >=9 g/dL.\n     \n     \n 10. Have an Eastern Cooperative Oncology Group (ECOG) performance status of =<2.\n 11. Must meet the following criteria: 1. Female patients who: * Are postmenopausal for at least 1 year before the screening visit, OR\n          * Are surgically sterile, OR\n          * If they are of childbearing potential, agree to practice 1 highly effective method of contraception and 1 additional effective (barrier) method at the same time, from the time of signing the informed consent through 4 months after the last dose of study drug, OR\n          * Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient, from the time of signing the informed consent through 4 months after that last dose of study drug. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together.)\n         \n         \n      2. Male patients, even if surgically sterilized (ie, status postvasectomy), who: * Agree to practice effective barrier contraception during the entire study treatment period and through 4 months after the last dose of study drug, OR\n          * Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient, during the entire study treatment period and through 4 months after that last dose of study drug. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together.)\n         \n         \n     \n     \n 12. Have the willingness and ability to comply with scheduled visit and study procedures.\n\n","\n\n 1.  Expansion part only: received any prior not specified ALK inhibitor.\n 2.  Expansion part only: received more than 2 prior ALK inhibitors. Note: The safety evaluation lead-in part allows patients with any line of prior ALK inhibitor which includes treatment-naÃ¯ve patients; however, ALK inhibitor-naÃ¯ve patients may be enrolled after the confirmation of first 3 DLT evaluable patients to have no more than 1 DLT during Cycle 1 by investigator's judgement.\n 3.  Received ALK inhibitor within 7 days before the first dose of Brigatinib.\n 4.  Previously received more than 1 regimen (more than 3 regimens in the safety evaluation lead-in part) of systemic anticancer therapy (not specified ALK inhibitor) for locally advanced or metastatic disease. Note: A systemic anticancer therapy regimen will be counted if it is administered over at least 1 cycle. A new anticancer agent used as maintenance therapy will be counted as a new regimen unless it was previously used as initial anticancer therapy. Neoadjuvant or adjuvant systemic anticancer therapy will be counted as a prior regimen if completion of (neo) adjuvant therapy occurred <12 months before the first dose of Brigatinib.\n 5.  Treatment with any investigational products except for specified ALK inhibitor within 30 days or 5 half-lives of that investigational agent, whichever is longer, before the first dose of Brigatinib.\n 6.  Received chemotherapy or radiation within 14 days before the first dose of brigatinib, except SRS or stereotactic body radiation therapy.\n 7.  Received antineoplastic monoclonal antibodies within 30 days before the first dose of brigatinib.\n 8.  Received systemic treatment with strong inhibitors or strong and moderate inducers of cytochrome P450 (CYP) 3A within 7 days before the first dose of brigatinib.\n 9.  Had major surgery within 30 days before the first dose of brigatinib. Minor surgical procedures such as venous catheter placement or minimally invasive biopsies are allowed.\n 10. Have been diagnosed with another primary malignancy other than NSCLC, except for the following adequately/definitively treated malignancies: nonmelanoma skin cancer, cervical cancer in situ, nonmetastatic prostate cancer; or patients with another primary malignancy who are definitively relapse-free with at least 3 years elapsed since the diagnosis of the other primary malignancy.\n 11. Have symptomatic central nervous system (CNS) metastases (parenchymal or leptomeningeal) at screening or asymptomatic disease requiring an increasing dose of corticosteroids to control symptoms within 7 days before the first dose of brigatinib. Note: If a patient has worsening neurological symptoms or signs due to CNS metastasis, the patient needs to complete local therapy and be neurologically stable (with no requirement for an increasing dose of corticosteroids or use of anticonvulsants for symptomatic control) for 7 days before the first dose of brigatinib.\n 12. Have current spinal cord compression (symptomatic or asymptomatic and detected by radiographic imaging). Patients with asymptomatic leptomeningeal disease and without cord compression are allowed.\n 13. Have ongoing or history of interstitial lung disease (ILD) (including interstitial pneumonitis, pneumonitis, radiation pneumonitis, drug-related pneumonitis, organized pneumonia, and pulmonary alveolitis).\n 14. Have significant, uncontrolled, or active cardiovascular disease, specifically including, but not limited to: 1. Myocardial infarction within 6 months before the first dose of brigatinib.\n      2. Unstable angina within 6 months before the first dose of brigatinib.\n      3. Congestive heart failure within 6 months before the first dose of brigatinib.\n      4. Uncontrolled atrial arrhythmias despite appropriate medical therapy.\n      5. History of ventricular arrhythmia, including history of ventricular tachycardia, ventricular fibrillation, or torsades de pointes. Patients with premature ventricular contractions are allowed.\n      6. Cerebrovascular accident or transient ischemic attack within 6 months before the first dose of brigatinib.\n      7. Resting heart rate <60 bpm.\n     \n     \n 15. Have uncontrolled hypertension. Patients with hypertension should be under treatment at the start of screening and demonstrate adequate control of blood pressure.\n 16. Have an ongoing or active infection, including, but not limited to, the requirement for intravenous antibiotics.\n 17. Have a known history of HIV infection. Testing is not required in the absence of history.\n 18. Hepatitis B surface antigen (HBsAg) positive, detectable hepatitis B viral load, or detectable hepatitis C virus (HCV) infection viral load. Note: Patients who have positive hepatitis B core antibody (HBcAb) or hepatitis B surface antibody (HBsAb) can be enrolled but must have an undetectable hepatitis B viral load. Patients who have positive HCV antibody can be enrolled but must have an undetectable hepatitis C viral load.\n 19. Have malabsorption syndrome or other gastrointestinal illness that could affect oral absorption of brigatinib.\n 20. Have a known or suspected hypersensitivity to brigatinib or its excipients.\n 21. Female patients who are lactating and breastfeeding or have a positive serum pregnancy test during the screening period.\n 22. Have any condition or illness that, in the opinion of the investigator, would compromise patient safety or interfere with the evaluation of brigatinib.",{"$nulls":4},"Actual","2018-01-25","Actual","Anticipated","2021-05-31","Anticipated","2018-03-01","2018-01-11","2018-01-23","2018-03-29","No",null,"Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","20 Years",null,"All",null,"No","Yes",{"$nulls":3},"No","No",{"$nulls":17},"U1111-1204-8752","WHO","Confirmed Objective Response Rate (ORR) in the Main Cohort of the Expansion Part","ORR is defined the percentage of the participants who are confirmed to have achieved complete response (CR) or partial response (PR) per an Independent Review Committee (IRC) using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 after the initiation of study treatment.","Up to 23 months","Confirmed ORR in the Overall Population of the Expansion Part|Duration of Response (DOR) in the Main Cohort and in the Overall Population of the Expansion Part|Progression-Free Survival (PFS) in the Main Cohort and in the Overall Population of the Expansion Part|Disease Control Rate (DCR) in the Main Cohort and in the Overall Population of the Expansion Part|Time to Response in the Main Cohort and in the Overall Population of the Expansion Part|Overall Survival (OS) in the Main Cohort and in the Overall Population of the Expansion Part|Central Nervous System (CNS) Response in the Main Cohort and in the Overall Population of the Expansion Part|Time on Treatment in the Main Cohort and in the Overall Population of the Expansion Part|Confirmed ORR in the Main Cohort of the Expansion Part|Patient-Reported Outcomes (PROs) of Health-Related Quality of Life (HRQOL) Scores and Symptoms of Lung Cancer in the Main Cohort of the Expansion Part|Cmax: Maximum Observed Plasma Concentration for Brigatinib on Cycle 1 Days 1 and 22|tmax: Time of First Occurrence of Cmax for Brigatinib on Cycle 1 Days 1 and 22|AUC: Area under the Plasma Concentration-Time Curve for Brigatinib on Cycle 1 Days 1 and 22","Up to 41 months|DOR will be assessed by an IRC, per RECIST version 1.1. DOR is defined as the time between the first documentation of objective tumor response (CR or PR) and the first subsequent documentation of objective progressive disease (PD) or death due to any cause, whichever occurs first.|PFS will be assessed by an IRC, per RECIST version 1.1. PFS is defined as the time from the start of study treatment to the first documentation of objective PD or to death due to any cause, whichever occurs first.|DCR will be assessed by an IRC, per RECIST version 1.1. DCR is defined as the percentage of participants who are confirmed to have achieved CR or PR or have a best overall response of stable disease (SD), per RECIST version 1.1, for 6 weeks or more after initiation of study drug.|Time to response will be assessed by an IRC, per RECIST version 1.1. Time to response is defined as the time interval from the date of the first dose of study treatment until the initial observation of CR or PR for patients with confirmed CR/PR.|OS is the time from the start of study treatment to the date of death.|CNS response will be assessed by an IRC, per modified RECIST version 1.1 for assessment of intracranial efficacy. CNS response is defined as the percentage of the participants who have achieved CR or PR in the intracranial CNS per modified RECIST version 1.1 as evaluated by an IRC after the initiation of study treatment.|Time on treatment is the time interval from the first dose to the last dose of Brigatinib.|The percentage of participants who are confirmed to have achieved CR or PR per investigator using RECIST version 1.1 after the initiation of study treatment.|PROs of HRQOL scores and symptoms of lung cancer, assessed with European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30, its lung cancer module QLQ-LC13, and the 5-level version of EuroQol 5-dimensional questionnaire (EQ-5D-5L) which are related to patient health, symptoms, and problems. Participants will answer for these questionalries. EORTC-QLQ-C30 contains 28 questions (4-point scale where 1=Not at all|Pre-dose and at multiple time points (0.5, 1, 2, 4, 6, 8, 12, 24; up to 24 hrs) post-dose of Cycle 1 Days 1 and 22","Up to 41 months|best to 4=Very Much","medicalinformation@tpna.com","Takeda Study Registration Call Center",-5028,"Nagoya, Aichi, Japan|Kashiwa, Chiba, Japan|Matsuyama, Ehime, Japan|Akashi, Hyogo, Japan|Fukuoka, Japan Niigata Cancer Center HospitalNiigata, Japan Okayama University HospitalOkayama, Japan|Hirakata, Osaka, Japan Kindai University HospitalOsakasayama, Osaka, Japan|Sunto-Gun, Shizuoka, Japan|Chuo-Ku, Tokyo, Japan Cancer Institute HospitalKoto-Ku, Tokyo, Japan",null,"Japan","Aichi Aichi Cancer Center Hospital|Chiba National Cancer Center Hospital East|Ehime Shikoku Cancer Center|Hyogo Hyogo Cancer Center|National Hospital Organization Kyushu Cancer Center|Osaka Kansai Medical University Hospital|Shizuoka Shizuoka Cancer Center|Tokyo National Cancer Center Hospital",{"$nulls":3},"Study Director","2018-03-29","2020-05-25T16:38:37.488","2020-05-26T17:10:42.972","NCT03410108"]
["5ecbf48dfeab101b15530970","NCT03410108","2018-05-14","Takeda","TAK","Recruiting","Phase 2 Study of Brigatinib in Japanese Patients With ALK-Positive Non-Small Cell Lung Cancer (NSCLC)","Brigatinib","TK Inhibitor|ALK Inhibitor","No",null,"No",null,"Phase 2",1,80,"Anticipated","2018-01-17","2019-12-31","RR","Response Rate",{"$nulls":3},"The purpose of this study is to evaluate efficacy and safety of Brigatinib in Japanese patients with anaplastic lymphoma kinase (ALK)-positive NSCLC that has progressed after 1 or 2 lines of prior ALK inhibitor therapy.","The drug being tested in this study is called brigatinib. Brigatinib is being tested in patients with ALK-positive NSCLC in order to evaluate efficacy and safety of oral doses of brigatinib in Japanese patients with ALK-positive NSCLC.\n\nThe study will enroll approximately 80 participants. Participants will be enrolled in non-randomized and opened manner:\n\n- Brigatinib 90 mg for the first 7 days, followed by Brigatinib 180 mg of Brigatinib tablets, once daily in a 28-days cycle.\n\nAll participants will be asked to take tablets of brigatinib once daily with or without food throughout the study.\n\nThis multi-center trial will be conducted in Japan. The overall time to participate in this study is approximately 41 months. Participants will make multiple visits to the clinic during the treatment period, and posttreatment period including a follow-up assessment after last dose of study drug.","A Single-Arm, Multicenter, Phase 2 Study of Brigatinib in Japanese Patients With ALK-Positive Non-Small Cell Lung Cancer (NSCLC)","Brigatinib-2001","ALK-positive Advanced NSCLC","Non-Small-Cell Lung Cancer","Oncology Solid Tumor","Oncology","Experimental","Brigatinib 90 mg + Brigatinib 180 mg","90 mg of Brigatinib tablets, once daily for 7 days, followed by 180 mg of Brigatinib tablets, once daily in a 28-days cycle.","Drug","Brigatinib","Brigatinib tablet",null,"Brigatinib 90 mg + Brigatinib 180 mg","\n\n 1.  Male or female Japanese patients aged >=20 years on the day of consent.\n 2.  Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.\n 3.  Have histologically or cytologically confirmed stage IIIB, stage IIIC (locally advanced or recurrent and not a candidate for definitive multimodality therapy), or stage IV NSCLC.\n 4.  Must meet 1 of the following 2 criteria: 1. Have documentation of ALK rearrangement by a positive result from the Vysis ALK Break Apart FISH [fluorescence in situ hybridization] Probe Kit, the Nichirei Histofine ALK iAEP Kit, or the Ventana ALK (D5F3) CDx Assay at any time during prior disease course.\n      2. Had a documented ALK rearrangement by a different test at any time during prior disease course, and adequate tissue available for central laboratory testing by the Vysis ALK Break Apart FISH test. Central confirmation of ALK rearrangement is not required before enrollment.\n     \n     \n 5.  The expansion part only: had documented progressive disease (PD) during treatment or within 30 days after treatment with ALK inhibitor. * Note 1: The expansion part consists of the main cohort and a subcohort based on prior ALK inhibitor treatment. The main cohort includes patients who had previously received alectinib (as their only ALK inhibitor) or both crizotinib and alectinib (regardless the sequence of those 2 ALK inhibitors), and a total of 47 patients will be enrolled. Patients with all other sequences of up to 2 prior ALK inhibitor(s) may be included in the subcohort, and the number of patients will be limited to 20.\n      * Note 2: Patients who will be included in the main cohort should have documented PD during treatment or within 30 days after treatment with alectinib.\n     \n     \n 6.  Have at least 1 measurable (ie, target) lesion per RECIST version 1.1. Note: Previously irradiated lesions may not be used for target lesions, unless there is unambiguous radiological progression after radiotherapy. Brain lesions may not be used as target lesions if they were 1) previously treated with whole brain radiation therapy (WBRT) within 3 months, or 2) previously treated by stereotactic radiosurgery (SRS) or surgical resection.\n 7.  Recovered from toxicities related to prior anticancer therapy to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03 Grade =<1. Note: Treatment-related alopecia is allowed.\n 8.  Have a life expectancy of >=3 months.\n 9.  Have adequate organ and hematologic function, as determined by: 1. Both alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =<2.5 times the upper limit of the normal range (ULN) (=<5Ã—ULN is acceptable if liver metastases are present).\n      2. Total serum bilirubin =<1.5Ã—ULN (<3.0Ã—ULN for patients with Gilbert syndrome).\n      3. Serum creatinine <1.5Ã—ULN. For patients with creatinine levels above or equal to 1.5Ã—ULN, the patient is eligible if the estimated creatinine clearance using the Cockcroft-Gault formula is â‰¥30 mL/minute.\n      4. Serum lipase =<1.5Ã—ULN and serum amylase =<1.5Ã—ULN.\n      5. Absolute neutrophil count (ANC) >=1.5Ã—10^9/L.\n      6. Platelet count >=75Ã—10^9/L.\n      7. Hemoglobin >=9 g/dL.\n     \n     \n 10. Have an Eastern Cooperative Oncology Group (ECOG) performance status of =<2.\n 11. Must meet the following criteria: 1. Female patients who: * Are postmenopausal for at least 1 year before the screening visit, OR\n          * Are surgically sterile, OR\n          * If they are of childbearing potential, agree to practice 1 highly effective method of contraception and 1 additional effective (barrier) method at the same time, from the time of signing the informed consent through 4 months after the last dose of study drug, OR\n          * Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient, from the time of signing the informed consent through 4 months after that last dose of study drug. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together.)\n         \n         \n      2. Male patients, even if surgically sterilized (ie, status postvasectomy), who: * Agree to practice effective barrier contraception during the entire study treatment period and through 4 months after the last dose of study drug, OR\n          * Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient, during the entire study treatment period and through 4 months after that last dose of study drug. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together.)\n         \n         \n     \n     \n 12. Have the willingness and ability to comply with scheduled visit and study procedures.\n\n","\n\n 1.  Expansion part only: received any prior not specified ALK inhibitor.\n 2.  Expansion part only: received more than 2 prior ALK inhibitors. Note: The safety evaluation lead-in part allows patients with any line of prior ALK inhibitor which includes treatment-naÃ¯ve patients; however, ALK inhibitor-naÃ¯ve patients may be enrolled after the confirmation of first 3 DLT evaluable patients to have no more than 1 DLT during Cycle 1 by investigator's judgement.\n 3.  Received ALK inhibitor within 7 days before the first dose of Brigatinib.\n 4.  Previously received more than 1 regimen (more than 3 regimens in the safety evaluation lead-in part) of systemic anticancer therapy (not specified ALK inhibitor) for locally advanced or metastatic disease. Note: A systemic anticancer therapy regimen will be counted if it is administered over at least 1 cycle. A new anticancer agent used as maintenance therapy will be counted as a new regimen unless it was previously used as initial anticancer therapy. Neoadjuvant or adjuvant systemic anticancer therapy will be counted as a prior regimen if completion of (neo) adjuvant therapy occurred <12 months before the first dose of Brigatinib.\n 5.  Treatment with any investigational products except for specified ALK inhibitor within 30 days or 5 half-lives of that investigational agent, whichever is longer, before the first dose of Brigatinib.\n 6.  Received chemotherapy or radiation within 14 days before the first dose of brigatinib, except SRS or stereotactic body radiation therapy.\n 7.  Received antineoplastic monoclonal antibodies within 30 days before the first dose of brigatinib.\n 8.  Received systemic treatment with strong inhibitors or strong and moderate inducers of cytochrome P450 (CYP) 3A within 7 days before the first dose of brigatinib.\n 9.  Had major surgery within 30 days before the first dose of brigatinib. Minor surgical procedures such as venous catheter placement or minimally invasive biopsies are allowed.\n 10. Have been diagnosed with another primary malignancy other than NSCLC, except for the following adequately/definitively treated malignancies: nonmelanoma skin cancer, cervical cancer in situ, nonmetastatic prostate cancer; or patients with another primary malignancy who are definitively relapse-free with at least 3 years elapsed since the diagnosis of the other primary malignancy.\n 11. Have symptomatic central nervous system (CNS) metastases (parenchymal or leptomeningeal) at screening or asymptomatic disease requiring an increasing dose of corticosteroids to control symptoms within 7 days before the first dose of brigatinib. Note: If a patient has worsening neurological symptoms or signs due to CNS metastasis, the patient needs to complete local therapy and be neurologically stable (with no requirement for an increasing dose of corticosteroids or use of anticonvulsants for symptomatic control) for 7 days before the first dose of brigatinib.\n 12. Have current spinal cord compression (symptomatic or asymptomatic and detected by radiographic imaging). Patients with asymptomatic leptomeningeal disease and without cord compression are allowed.\n 13. Have ongoing or history of interstitial lung disease (ILD) (including interstitial pneumonitis, pneumonitis, radiation pneumonitis, drug-related pneumonitis, organized pneumonia, and pulmonary alveolitis).\n 14. Have significant, uncontrolled, or active cardiovascular disease, specifically including, but not limited to: 1. Myocardial infarction within 6 months before the first dose of brigatinib.\n      2. Unstable angina within 6 months before the first dose of brigatinib.\n      3. Congestive heart failure within 6 months before the first dose of brigatinib.\n      4. Uncontrolled atrial arrhythmias despite appropriate medical therapy.\n      5. History of ventricular arrhythmia, including history of ventricular tachycardia, ventricular fibrillation, or torsades de pointes. Patients with premature ventricular contractions are allowed.\n      6. Cerebrovascular accident or transient ischemic attack within 6 months before the first dose of brigatinib.\n      7. Resting heart rate <60 bpm.\n     \n     \n 15. Have uncontrolled hypertension. Patients with hypertension should be under treatment at the start of screening and demonstrate adequate control of blood pressure.\n 16. Have an ongoing or active infection, including, but not limited to, the requirement for intravenous antibiotics.\n 17. Have a known history of HIV infection. Testing is not required in the absence of history.\n 18. Hepatitis B surface antigen (HBsAg) positive, detectable hepatitis B viral load, or detectable hepatitis C virus (HCV) infection viral load. Note: Patients who have positive hepatitis B core antibody (HBcAb) or hepatitis B surface antibody (HBsAb) can be enrolled but must have an undetectable hepatitis B viral load. Patients who have positive HCV antibody can be enrolled but must have an undetectable hepatitis C viral load.\n 19. Have malabsorption syndrome or other gastrointestinal illness that could affect oral absorption of brigatinib.\n 20. Have a known or suspected hypersensitivity to brigatinib or its excipients.\n 21. Female patients who are lactating and breastfeeding or have a positive serum pregnancy test during the screening period.\n 22. Have any condition or illness that, in the opinion of the investigator, would compromise patient safety or interfere with the evaluation of brigatinib.",{"$nulls":4},"Actual","2018-01-25","Actual","Anticipated","2021-05-31","Anticipated","2018-05-01","2018-01-11","2018-01-23","2018-05-11","No",null,"Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","20 Years",null,"All",null,"No","Yes",{"$nulls":3},"No","No",{"$nulls":17},"U1111-1204-8752","WHO","Confirmed Objective Response Rate (ORR) in the Main Cohort of the Expansion Part","ORR is defined the percentage of the participants who are confirmed to have achieved complete response (CR) or partial response (PR) per an Independent Review Committee (IRC) using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 after the initiation of study treatment.","Up to 23 months","Confirmed ORR in the Overall Population of the Expansion Part|Duration of Response (DOR) in the Main Cohort and in the Overall Population of the Expansion Part|Progression-Free Survival (PFS) in the Main Cohort and in the Overall Population of the Expansion Part|Disease Control Rate (DCR) in the Main Cohort and in the Overall Population of the Expansion Part|Time to Response in the Main Cohort and in the Overall Population of the Expansion Part|Overall Survival (OS) in the Main Cohort and in the Overall Population of the Expansion Part|Central Nervous System (CNS) Response in the Main Cohort and in the Overall Population of the Expansion Part|Time on Treatment in the Main Cohort and in the Overall Population of the Expansion Part|Confirmed ORR in the Main Cohort of the Expansion Part|Patient-Reported Outcomes (PROs) of Health-Related Quality of Life (HRQOL) Scores and Symptoms of Lung Cancer in the Main Cohort of the Expansion Part|Cmax: Maximum Observed Plasma Concentration for Brigatinib on Cycle 1 Days 1 and 22|tmax: Time of First Occurrence of Cmax for Brigatinib on Cycle 1 Days 1 and 22|AUC: Area under the Plasma Concentration-Time Curve for Brigatinib on Cycle 1 Days 1 and 22","Up to 41 months|DOR will be assessed by an IRC, per RECIST version 1.1. DOR is defined as the time between the first documentation of objective tumor response (CR or PR) and the first subsequent documentation of objective progressive disease (PD) or death due to any cause, whichever occurs first.|PFS will be assessed by an IRC, per RECIST version 1.1. PFS is defined as the time from the start of study treatment to the first documentation of objective PD or to death due to any cause, whichever occurs first.|DCR will be assessed by an IRC, per RECIST version 1.1. DCR is defined as the percentage of participants who are confirmed to have achieved CR or PR or have a best overall response of stable disease (SD), per RECIST version 1.1, for 6 weeks or more after initiation of study drug.|Time to response will be assessed by an IRC, per RECIST version 1.1. Time to response is defined as the time interval from the date of the first dose of study treatment until the initial observation of CR or PR for patients with confirmed CR/PR.|OS is the time from the start of study treatment to the date of death.|CNS response will be assessed by an IRC, per modified RECIST version 1.1 for assessment of intracranial efficacy. CNS response is defined as the percentage of the participants who have achieved CR or PR in the intracranial CNS per modified RECIST version 1.1 as evaluated by an IRC after the initiation of study treatment.|Time on treatment is the time interval from the first dose to the last dose of Brigatinib.|The percentage of participants who are confirmed to have achieved CR or PR per investigator using RECIST version 1.1 after the initiation of study treatment.|PROs of HRQOL scores and symptoms of lung cancer, assessed with European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30, its lung cancer module QLQ-LC13, and the 5-level version of EuroQol 5-dimensional questionnaire (EQ-5D-5L) which are related to patient health, symptoms, and problems. Participants will answer for these questionalries. EORTC-QLQ-C30 contains 28 questions (4-point scale where 1=Not at all|Pre-dose and at multiple time points (0.5, 1, 2, 4, 6, 8, 12, 24; up to 24 hrs) post-dose of Cycle 1 Days 1 and 22","Up to 41 months|best to 4=Very Much","medicalinformation@tpna.com","Takeda Study Registration Call Center",-5028,"Nagoya, Aichi, Japan Fujita Health University HospitalToyoake, Aichi, Japan|Kashiwa, Chiba, Japan|Matsuyama, Ehime, Japan|Akashi, Hyogo, Japan|Fukuoka, Japan National Hospital Organization Kyushu Cancer CenterFukuoka, Japan Niigata Cancer Center HospitalNiigata, Japan Okayama University HospitalOkayama, Japan|Hirakata, Osaka, Japan Kindai University HospitalOsakasayama, Osaka, Japan|Sunto-Gun, Shizuoka, Japan|Chuo-Ku, Tokyo, Japan Cancer Institute HospitalKoto-Ku, Tokyo, Japan",null,"Japan","Aichi Aichi Cancer Center Hospital|Chiba National Cancer Center Hospital East|Ehime Shikoku Cancer Center|Hyogo Hyogo Cancer Center|Kyushu University Hospital|Osaka Kansai Medical University Hospital|Shizuoka Shizuoka Cancer Center|Tokyo National Cancer Center Hospital",{"$nulls":3},"Study Director","2018-05-11","2020-05-25T16:38:37.656","2020-05-26T17:10:42.972","NCT03410108"]
["5ecbf48de2561b1b11905e3c","NCT03410108","2018-06-08","Takeda","TAK","Recruiting","Phase 2 Study of Brigatinib in Japanese Patients With ALK-Positive Non-Small Cell Lung Cancer (NSCLC)","Brigatinib","TK Inhibitor|ALK Inhibitor","No",null,"No",null,"Phase 2",1,80,"Anticipated","2018-01-17","2019-12-31","RR","Response Rate",{"$nulls":3},"The purpose of this study is to evaluate efficacy and safety of Brigatinib in Japanese patients with anaplastic lymphoma kinase (ALK)-positive NSCLC that has progressed after 1 or 2 lines of prior ALK inhibitor therapy.","The drug being tested in this study is called brigatinib. Brigatinib is being tested in patients with ALK-positive NSCLC in order to evaluate efficacy and safety of oral doses of brigatinib in Japanese patients with ALK-positive NSCLC.\n\nThe study will enroll approximately 80 participants. Participants will be enrolled in non-randomized and opened manner:\n\n- Brigatinib 90 mg for the first 7 days, followed by Brigatinib 180 mg of Brigatinib tablets, once daily in a 28-days cycle.\n\nAll participants will be asked to take tablets of brigatinib once daily with or without food throughout the study.\n\nThis multi-center trial will be conducted in Japan. The overall time to participate in this study is approximately 41 months. Participants will make multiple visits to the clinic during the treatment period, and posttreatment period including a follow-up assessment after last dose of study drug.","A Single-Arm, Multicenter, Phase 2 Study of Brigatinib in Japanese Patients With ALK-Positive Non-Small Cell Lung Cancer (NSCLC)","Brigatinib-2001","ALK-positive Advanced NSCLC","Non-Small-Cell Lung Cancer","Oncology Solid Tumor","Oncology","Experimental","Brigatinib 90 mg + Brigatinib 180 mg","90 mg of Brigatinib tablets, once daily for 7 days, followed by 180 mg of Brigatinib tablets, once daily in a 28-days cycle.","Drug","Brigatinib","Brigatinib tablet",null,"Brigatinib 90 mg + Brigatinib 180 mg","\n\n 1.  Male or female Japanese patients aged >=20 years on the day of consent.\n 2.  Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.\n 3.  Have histologically or cytologically confirmed stage IIIB, stage IIIC (locally advanced or recurrent and not a candidate for definitive multimodality therapy), or stage IV NSCLC.\n 4.  Must meet 1 of the following 2 criteria: 1. Have documentation of ALK rearrangement by a positive result from the Vysis ALK Break Apart FISH [fluorescence in situ hybridization] Probe Kit, the Nichirei Histofine ALK iAEP Kit, or the Ventana ALK (D5F3) CDx Assay at any time during prior disease course.\n      2. Had a documented ALK rearrangement by a different test at any time during prior disease course, and adequate tissue available for central laboratory testing by the Vysis ALK Break Apart FISH test. Central confirmation of ALK rearrangement is not required before enrollment.\n     \n     \n 5.  The expansion part only: had documented progressive disease (PD) during treatment or within 30 days discontinuation of treatment with ALK inhibitor. * Note 1: The expansion part consists of the main cohort and a subcohort based on prior ALK inhibitor treatment. The main cohort includes patients who had previously received alectinib (as their only ALK inhibitor) or both crizotinib and alectinib (regardless the sequence of those 2 ALK inhibitors), and a total of 47 patients will be enrolled. Patients with all other sequences of up to 2 prior ALK inhibitor(s) may be included in the subcohort, and the number of patients will be limited to 20.\n      * Note 2: Patients who will be included in the main cohort should have documented PD during treatment or within 30 days discontinuation of treatment with alectinib.\n     \n     \n 6.  Have at least 1 measurable (ie, target) lesion per RECIST version 1.1. Note: Previously irradiated lesions may not be used for target lesions, unless there is unambiguous radiological progression after radiotherapy. Brain lesions may not be used as target lesions if they were 1) previously treated with whole brain radiation therapy (WBRT) within 3 months, or 2) previously treated by stereotactic radiosurgery (SRS) or surgical resection.\n 7.  Recovered from toxicities related to prior anticancer therapy to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03 Grade =<1. Note: Treatment-related alopecia is allowed.\n 8.  Have a life expectancy of >=3 months.\n 9.  Have adequate organ and hematologic function, as determined by: 1. Both alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =<2.5 times the upper limit of the normal range (ULN) (=<5Ã—ULN is acceptable if liver metastases are present).\n      2. Total serum bilirubin =<1.5Ã—ULN (<3.0Ã—ULN for patients with Gilbert syndrome).\n      3. Serum creatinine <1.5Ã—ULN. For patients with creatinine levels above or equal to 1.5Ã—ULN, the patient is eligible if the estimated creatinine clearance using the Cockcroft-Gault formula is â‰¥30 mL/minute.\n      4. Serum lipase =<1.5Ã—ULN and serum amylase =<1.5Ã—ULN.\n      5. Absolute neutrophil count (ANC) >=1.5Ã—10^9/L.\n      6. Platelet count >=75Ã—10^9/L.\n      7. Hemoglobin >=9 g/dL.\n      8. Percutaneous oxygen saturation (SpO2) >=94% without oxygen support. Patients who need oxygen support are excluded.\n     \n     \n 10. Have an Eastern Cooperative Oncology Group (ECOG) performance status of =<2.\n 11. Must meet the following criteria: 1. Female patients who: * Are postmenopausal for at least 1 year before the screening visit, OR\n          * Are surgically sterile, OR\n          * If they are of childbearing potential, agree to practice 1 highly effective non-hormonal method of contraception and 1 additional effective (barrier) method at the same time, from the time of signing the informed consent through 4 months after the last dose of study drug, OR\n          * Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient, from the time of signing the informed consent through 4 months after that last dose of study drug. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together.)\n         \n         \n      2. Male patients, even if surgically sterilized (ie, status postvasectomy), who: * Agree to practice effective barrier contraception during the entire study treatment period and through 4 months after the last dose of study drug, OR\n          * Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient, during the entire study treatment period and through 4 months after that last dose of study drug. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together.)\n         \n         \n     \n     \n 12. Have the willingness and ability to comply with scheduled visit and study procedures.\n\n","\n\n 1.  Expansion part only: received any prior not specified ALK inhibitor.\n 2.  Expansion part only: received more than 2 prior ALK inhibitors. Note: The safety evaluation lead-in part allows patients with any line of prior ALK inhibitor which includes treatment-naÃ¯ve patients; however, ALK inhibitor-naÃ¯ve patients may be enrolled after the confirmation of first 3 DLT evaluable patients to have no more than 1 DLT during Cycle 1 by investigator's judgement.\n 3.  Received ALK inhibitor within 7 days before the first dose of Brigatinib.\n 4.  Previously received more than 1 regimen (more than 3 regimens in the safety evaluation lead-in part) of systemic anticancer therapy (not specified ALK inhibitor) for locally advanced or metastatic disease. Note: A systemic anticancer therapy regimen will be counted if it is administered over at least 1 cycle. A new anticancer agent used as maintenance therapy will be counted as a new regimen unless it was previously used as initial anticancer therapy. Neoadjuvant or adjuvant systemic anticancer therapy will be counted as a prior regimen if completion of (neo) adjuvant therapy occurred <12 months before the first dose of Brigatinib.\n 5.  Treatment with any investigational products except for specified ALK inhibitor within 30 days or 5 half-lives of that investigational agent, whichever is longer, before the first dose of Brigatinib.\n 6.  Received chemotherapy or radiation within 14 days before the first dose of brigatinib, except SRS or stereotactic body radiation therapy.\n 7.  Received antineoplastic monoclonal antibodies within 30 days before the first dose of brigatinib.\n 8.  Received systemic treatment with strong inhibitors or strong and moderate inducers of cytochrome P450 (CYP) 3A within 7 days before the first dose of brigatinib.\n 9.  Had major surgery within 30 days before the first dose of brigatinib. Minor surgical procedures such as venous catheter placement or minimally invasive biopsies are allowed.\n 10. Have been diagnosed with another primary malignancy other than NSCLC, except for the following adequately/definitively treated malignancies: nonmelanoma skin cancer, cervical cancer in situ, nonmetastatic prostate cancer; or patients with another primary malignancy who are definitively relapse-free with at least 3 years elapsed since the diagnosis of the other primary malignancy.\n 11. Have symptomatic central nervous system (CNS) metastases (parenchymal or leptomeningeal) at screening or asymptomatic disease requiring an increasing dose of corticosteroids to control symptoms within 7 days before the first dose of brigatinib. Note: If a patient has worsening neurological symptoms or signs due to CNS metastasis, the patient needs to complete local therapy and be neurologically stable (with no requirement for an increasing dose of corticosteroids or use of anticonvulsants for symptomatic control) for 7 days before the first dose of brigatinib.\n 12. Have current spinal cord compression (symptomatic or asymptomatic and detected by radiographic imaging). Patients with asymptomatic leptomeningeal disease and without cord compression are allowed.\n 13. Have ongoing or history of interstitial lung disease (ILD) (including interstitial pneumonitis, pneumonitis, radiation pneumonitis, drug-related pneumonitis, organized pneumonia, and pulmonary alveolitis).\n 14. Have significant, uncontrolled, or active cardiovascular disease, specifically including, but not limited to: 1. Myocardial infarction within 6 months before the first dose of brigatinib.\n      2. Unstable angina within 6 months before the first dose of brigatinib.\n      3. Congestive heart failure within 6 months before the first dose of brigatinib.\n      4. Uncontrolled atrial arrhythmias despite appropriate medical therapy.\n      5. History of ventricular arrhythmia, including history of ventricular tachycardia, ventricular fibrillation, or torsades de pointes. Patients with premature ventricular contractions are allowed.\n      6. Cerebrovascular accident or transient ischemic attack within 6 months before the first dose of brigatinib.\n      7. Resting heart rate <60 bpm.\n     \n     \n 15. Have uncontrolled hypertension. Patients with hypertension should be under treatment at the start of screening and demonstrate adequate control of blood pressure.\n 16. Have an ongoing or active infection, including, but not limited to, the requirement for intravenous antibiotics.\n 17. Have a known history of HIV infection. Testing is not required in the absence of history.\n 18. Hepatitis B surface antigen (HBsAg) positive, detectable hepatitis B viral load, or detectable hepatitis C virus (HCV) infection viral load. Note: Patients who have positive hepatitis B core antibody (HBcAb) or hepatitis B surface antibody (HBsAb) can be enrolled but must have an undetectable hepatitis B viral load. Patients who have positive HCV antibody can be enrolled but must have an undetectable hepatitis C viral load.\n 19. Have malabsorption syndrome or other gastrointestinal illness that could affect oral absorption of brigatinib.\n 20. Have a known or suspected hypersensitivity to brigatinib or its excipients.\n 21. Female patients who are lactating and breastfeeding or have a positive serum pregnancy test during the screening period.\n 22. Have any condition or illness that, in the opinion of the investigator, would compromise patient safety or interfere with the evaluation of brigatinib.",{"$nulls":4},"Actual","2018-01-25","Actual","Anticipated","2021-05-31","Anticipated","2018-06-01","2018-01-11","2018-01-23","2018-06-07","No",null,"Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","20 Years",null,"All",null,"No","Yes",{"$nulls":3},"No","No",{"$nulls":17},"U1111-1204-8752|JapicCTI-183823","WHO|Registry Identifier: JapicCTI","Confirmed Objective Response Rate (ORR) in the Main Cohort of the Expansion Part","ORR is defined the percentage of the participants who are confirmed to have achieved complete response (CR) or partial response (PR) per an Independent Review Committee (IRC) using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 after the initiation of study treatment.","Up to 23 months","Confirmed ORR in the Overall Population of the Expansion Part|Duration of Response (DOR) in the Main Cohort and in the Overall Population of the Expansion Part|Progression-Free Survival (PFS) in the Main Cohort and in the Overall Population of the Expansion Part|Disease Control Rate (DCR) in the Main Cohort and in the Overall Population of the Expansion Part|Time to Response in the Main Cohort and in the Overall Population of the Expansion Part|Overall Survival (OS) in the Main Cohort and in the Overall Population of the Expansion Part|Central Nervous System (CNS) Response in the Main Cohort and in the Overall Population of the Expansion Part|Time on Treatment in the Main Cohort and in the Overall Population of the Expansion Part|Confirmed ORR in the Main Cohort of the Expansion Part|Patient-Reported Outcomes (PROs) of Health-Related Quality of Life (HRQOL) Scores and Symptoms of Lung Cancer in the Main Cohort of the Expansion Part|Cmax: Maximum Observed Plasma Concentration for Brigatinib on Cycle 1 Days 1 and 22|tmax: Time of First Occurrence of Cmax for Brigatinib on Cycle 1 Days 1 and 22|AUC: Area under the Plasma Concentration-Time Curve for Brigatinib on Cycle 1 Days 1 and 22","Up to 41 months|DOR will be assessed by an IRC, per RECIST version 1.1. DOR is defined as the time between the first documentation of objective tumor response (CR or PR) and the first subsequent documentation of objective progressive disease (PD) or death due to any cause, whichever occurs first.|PFS will be assessed by an IRC, per RECIST version 1.1. PFS is defined as the time from the start of study treatment to the first documentation of objective PD or to death due to any cause, whichever occurs first.|DCR will be assessed by an IRC, per RECIST version 1.1. DCR is defined as the percentage of participants who are confirmed to have achieved CR or PR or have a best overall response of stable disease (SD), per RECIST version 1.1, for 6 weeks or more after initiation of study drug.|Time to response will be assessed by an IRC, per RECIST version 1.1. Time to response is defined as the time interval from the date of the first dose of study treatment until the initial observation of CR or PR for patients with confirmed CR/PR.|OS is the time from the start of study treatment to the date of death.|CNS response will be assessed by an IRC, per modified RECIST version 1.1 for assessment of intracranial efficacy. CNS response is defined as the percentage of the participants who have achieved CR or PR in the intracranial CNS per modified RECIST version 1.1 as evaluated by an IRC after the initiation of study treatment.|Time on treatment is the time interval from the first dose to the last dose of Brigatinib.|The percentage of participants who are confirmed to have achieved CR or PR per investigator using RECIST version 1.1 after the initiation of study treatment.|PROs of HRQOL scores and symptoms of lung cancer, assessed with European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30, its lung cancer module QLQ-LC13, and the 5-level version of EuroQol 5-dimensional questionnaire (EQ-5D-5L) which are related to patient health, symptoms, and problems. Participants will answer for these questionalries. EORTC-QLQ-C30 contains 28 questions (4-point scale where 1=Not at all|Pre-dose and at multiple time points (0.5, 1, 2, 4, 6, 8, 12, 24; up to 24 hrs) post-dose of Cycle 1 Days 1 and 22","Up to 41 months|best to 4=Very Much","medicalinformation@tpna.com","Takeda Study Registration Call Center",-5028,"Nagoya, Aichi, Japan Fujita Health University HospitalToyoake, Aichi, Japan|Kashiwa, Chiba, Japan|Chiba, Japan Kyushu University HospitalFukuoka, Japan National Hospital Organization Kyushu Cancer CenterFukuoka, Japan Kyoto University HospitalKyoto, Japan Niigata Cancer Center HospitalNiigata, Japan Okayama University HospitalOkayama, Japan Osaka International Cancer InstituteOsaka, Japan|Matsuyama, Ehime, Japan|Akashi, Hyogo, Japan Kobe City Medical Center General HospitalKobe, Hyogo, Japan|Morioka, Iwate, Japan|Yokohama, Kanagawa, Japan|Sendai, Miyagi, Japan|Hirakata, Osaka, Japan Kindai University HospitalOsakasayama, Osaka, Japan|Ina, Saitama, Japan|Nagaizumi-Cho, Shizuoka, Japan|Shimotsuke, Tochigi, Japan|Chuo-Ku, Tokyo, Japan Cancer Institute HospitalKoto-Ku, Tokyo, Japan",null,"Japan","Aichi Aichi Cancer Center Hospital|Chiba National Cancer Center Hospital East|Chiba University Hospital|Ehime National Hospital Organization Shikoku Cancer Center|Hyogo Hyogo Cancer Center|Iwate Iwate Medical University Hospital|Kanagawa Kanagawa Cancer Center|Miyagi Sendai Kousei Hospital|Osaka Kansai Medical University Hospital|Saitama Saitama Cancer Center|Shizuoka Shizuoka Cancer Center|Tochigi Jichi Medical University Hospital|Tokyo National Cancer Center Hospital",{"$nulls":3},"Study Director","2018-06-07","2020-05-25T16:38:37.834","2020-05-26T17:10:42.972","NCT03410108"]
["5ecbf48e307e3d1b1f8d9dd4","NCT03410108","2018-08-31","Takeda","TAK","Recruiting","Phase 2 Study of Brigatinib in Japanese Patients With ALK-Positive Non-Small Cell Lung Cancer (NSCLC)","Brigatinib","TK Inhibitor|ALK Inhibitor","No",null,"No",null,"Phase 2",1,80,"Anticipated","2018-01-17","2019-12-31","RR","Response Rate",{"$nulls":3},"The purpose of this study is to evaluate efficacy and safety of Brigatinib in Japanese patients with anaplastic lymphoma kinase (ALK)-positive NSCLC that has progressed after 1 or 2 lines of prior ALK inhibitor therapy.","The drug being tested in this study is called brigatinib. Brigatinib is being tested in patients with ALK-positive NSCLC in order to evaluate efficacy and safety of oral doses of brigatinib in Japanese patients with ALK-positive NSCLC.\n\nThe study will enroll approximately 80 participants. Participants will be enrolled in non-randomized and opened manner:\n\n- Brigatinib 90 mg for the first 7 days, followed by Brigatinib 180 mg of Brigatinib tablets, once daily in a 28-days cycle.\n\nAll participants will be asked to take tablets of brigatinib once daily with or without food throughout the study.\n\nThis multi-center trial will be conducted in Japan. The overall time to participate in this study is approximately 41 months. Participants will make multiple visits to the clinic during the treatment period, and posttreatment period including a follow-up assessment after last dose of study drug.","A Single-Arm, Multicenter, Phase 2 Study of Brigatinib in Japanese Patients With ALK-Positive Non-Small Cell Lung Cancer (NSCLC)","Brigatinib-2001","ALK-positive Advanced NSCLC","Non-Small-Cell Lung Cancer","Oncology Solid Tumor","Oncology","Experimental","Brigatinib 90 mg + Brigatinib 180 mg","90 mg of Brigatinib tablets, once daily for 7 days, followed by 180 mg of Brigatinib tablets, once daily in a 28-days cycle.","Drug","Brigatinib","Brigatinib tablet",null,"Brigatinib 90 mg + Brigatinib 180 mg","\n\n 1.  Male or female Japanese patients aged >=20 years on the day of consent.\n 2.  Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.\n 3.  Have histologically or cytologically confirmed stage IIIB, stage IIIC (locally advanced or recurrent and not a candidate for definitive multimodality therapy), or stage IV NSCLC.\n 4.  Must meet 1 of the following 2 criteria: 1. Have documentation of ALK rearrangement by a positive result from the Vysis ALK Break Apart FISH [fluorescence in situ hybridization] Probe Kit, the Nichirei Histofine ALK iAEP Kit, or the Ventana ALK (D5F3) CDx Assay at any time during prior disease course.\n      2. Had a documented ALK rearrangement by a different test at any time during prior disease course, and adequate tissue available for central laboratory testing by the Vysis ALK Break Apart FISH test. Central confirmation of ALK rearrangement is not required before enrollment.\n     \n     \n 5.  The expansion part only: had documented progressive disease (PD) during treatment or within 30 days discontinuation of treatment with ALK inhibitor. * Note 1: The expansion part consists of the main cohort and a subcohort based on prior ALK inhibitor treatment. The main cohort includes patients who had previously received alectinib (as their only ALK inhibitor) or both crizotinib and alectinib (regardless the sequence of those 2 ALK inhibitors), and a total of 47 patients will be enrolled. Patients with all other sequences of up to 2 prior ALK inhibitor(s) may be included in the subcohort, and the number of patients will be limited to 20.\n      * Note 2: Patients who will be included in the main cohort should have documented PD during treatment or within 30 days discontinuation of treatment with alectinib.\n     \n     \n 6.  Have at least 1 measurable (ie, target) lesion per RECIST version 1.1. Note: Previously irradiated lesions may not be used for target lesions, unless there is unambiguous radiological progression after radiotherapy. Brain lesions may not be used as target lesions if they were 1) previously treated with whole brain radiation therapy (WBRT) within 3 months, or 2) previously treated by stereotactic radiosurgery (SRS) or surgical resection.\n 7.  Recovered from toxicities related to prior anticancer therapy to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03 Grade =<1. Note: Treatment-related alopecia is allowed.\n 8.  Have a life expectancy of >=3 months.\n 9.  Have adequate organ and hematologic function, as determined by: 1. Both alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =<2.5 times the upper limit of the normal range (ULN) (=<5Ã—ULN is acceptable if liver metastases are present).\n      2. Total serum bilirubin =<1.5Ã—ULN (<3.0Ã—ULN for patients with Gilbert syndrome).\n      3. Serum creatinine <1.5Ã—ULN. For patients with creatinine levels above or equal to 1.5Ã—ULN, the patient is eligible if the estimated creatinine clearance using the Cockcroft-Gault formula is â‰¥30 mL/minute.\n      4. Serum lipase =<1.5Ã—ULN and serum amylase =<1.5Ã—ULN.\n      5. Absolute neutrophil count (ANC) >=1.5Ã—10^9/L.\n      6. Platelet count >=75Ã—10^9/L.\n      7. Hemoglobin >=9 g/dL.\n      8. Percutaneous oxygen saturation (SpO2) >=94% without oxygen support. Patients who need oxygen support are excluded.\n     \n     \n 10. Have an Eastern Cooperative Oncology Group (ECOG) performance status of =<2.\n 11. Must meet the following criteria: 1. Female patients who: * Are postmenopausal for at least 1 year before the screening visit, OR\n          * Are surgically sterile, OR\n          * If they are of childbearing potential, agree to practice 1 highly effective non-hormonal method of contraception and 1 additional effective (barrier) method at the same time, from the time of signing the informed consent through 4 months after the last dose of study drug, OR\n          * Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient, from the time of signing the informed consent through 4 months after that last dose of study drug. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together.)\n         \n         \n      2. Male patients, even if surgically sterilized (ie, status postvasectomy), who: * Agree to practice effective barrier contraception during the entire study treatment period and through 4 months after the last dose of study drug, OR\n          * Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient, during the entire study treatment period and through 4 months after that last dose of study drug. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together.)\n         \n         \n     \n     \n 12. Have the willingness and ability to comply with scheduled visit and study procedures.\n\n","\n\n 1.  Expansion part only: received any prior not specified ALK inhibitor.\n 2.  Expansion part only: received more than 2 prior ALK inhibitors. Note: The safety evaluation lead-in part allows patients with any line of prior ALK inhibitor which includes treatment-naÃ¯ve patients; however, ALK inhibitor-naÃ¯ve patients may be enrolled after the confirmation of first 3 DLT evaluable patients to have no more than 1 DLT during Cycle 1 by investigator's judgement.\n 3.  Received ALK inhibitor within 7 days before the first dose of Brigatinib.\n 4.  Previously received more than 1 regimen (more than 3 regimens in the safety evaluation lead-in part) of systemic anticancer therapy (not specified ALK inhibitor) for locally advanced or metastatic disease. Note: A systemic anticancer therapy regimen will be counted if it is administered over at least 1 cycle. A new anticancer agent used as maintenance therapy will be counted as a new regimen unless it was previously used as initial anticancer therapy. Neoadjuvant or adjuvant systemic anticancer therapy will be counted as a prior regimen if completion of (neo) adjuvant therapy occurred <12 months before the first dose of Brigatinib.\n 5.  Treatment with any investigational products except for specified ALK inhibitor within 30 days or 5 half-lives of that investigational agent, whichever is longer, before the first dose of Brigatinib.\n 6.  Received chemotherapy or radiation within 14 days before the first dose of brigatinib, except SRS or stereotactic body radiation therapy.\n 7.  Received antineoplastic monoclonal antibodies within 30 days before the first dose of brigatinib.\n 8.  Received systemic treatment with strong inhibitors or strong and moderate inducers of cytochrome P450 (CYP) 3A within 7 days before the first dose of brigatinib.\n 9.  Had major surgery within 30 days before the first dose of brigatinib. Minor surgical procedures such as venous catheter placement or minimally invasive biopsies are allowed.\n 10. Have been diagnosed with another primary malignancy other than NSCLC, except for the following adequately/definitively treated malignancies: nonmelanoma skin cancer, cervical cancer in situ, nonmetastatic prostate cancer; or patients with another primary malignancy who are definitively relapse-free with at least 3 years elapsed since the diagnosis of the other primary malignancy.\n 11. Have symptomatic central nervous system (CNS) metastases (parenchymal or leptomeningeal) at screening or asymptomatic disease requiring an increasing dose of corticosteroids to control symptoms within 7 days before the first dose of brigatinib. Note: If a patient has worsening neurological symptoms or signs due to CNS metastasis, the patient needs to complete local therapy and be neurologically stable (with no requirement for an increasing dose of corticosteroids or use of anticonvulsants for symptomatic control) for 7 days before the first dose of brigatinib.\n 12. Have current spinal cord compression (symptomatic or asymptomatic and detected by radiographic imaging). Patients with asymptomatic leptomeningeal disease and without cord compression are allowed.\n 13. Have ongoing or history of interstitial lung disease (ILD) (including interstitial pneumonitis, pneumonitis, radiation pneumonitis, drug-related pneumonitis, organized pneumonia, and pulmonary alveolitis).\n 14. Have significant, uncontrolled, or active cardiovascular disease, specifically including, but not limited to: 1. Myocardial infarction within 6 months before the first dose of brigatinib.\n      2. Unstable angina within 6 months before the first dose of brigatinib.\n      3. Congestive heart failure within 6 months before the first dose of brigatinib.\n      4. Uncontrolled atrial arrhythmias despite appropriate medical therapy.\n      5. History of ventricular arrhythmia, including history of ventricular tachycardia, ventricular fibrillation, or torsades de pointes. Patients with premature ventricular contractions are allowed.\n      6. Cerebrovascular accident or transient ischemic attack within 6 months before the first dose of brigatinib.\n      7. Resting heart rate <60 bpm.\n     \n     \n 15. Have uncontrolled hypertension. Patients with hypertension should be under treatment at the start of screening and demonstrate adequate control of blood pressure.\n 16. Have an ongoing or active infection, including, but not limited to, the requirement for intravenous antibiotics.\n 17. Have a known history of HIV infection. Testing is not required in the absence of history.\n 18. Hepatitis B surface antigen (HBsAg) positive, detectable hepatitis B viral load, or detectable hepatitis C virus (HCV) infection viral load. Note: Patients who have positive hepatitis B core antibody (HBcAb) or hepatitis B surface antibody (HBsAb) can be enrolled but must have an undetectable hepatitis B viral load. Patients who have positive HCV antibody can be enrolled but must have an undetectable hepatitis C viral load.\n 19. Have malabsorption syndrome or other gastrointestinal illness that could affect oral absorption of brigatinib.\n 20. Have a known or suspected hypersensitivity to brigatinib or its excipients.\n 21. Female patients who are lactating and breastfeeding or have a positive serum pregnancy test during the screening period.\n 22. Have any condition or illness that, in the opinion of the investigator, would compromise patient safety or interfere with the evaluation of brigatinib.",{"$nulls":4},"Actual","2018-01-25","Actual","Anticipated","2020-04-30","Anticipated","2018-08-01","2018-01-11","2018-01-23","2018-08-29","No",null,"Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","20 Years",null,"All",null,"No","Yes",{"$nulls":3},"No","No",{"$nulls":17},"U1111-1204-8752|JapicCTI-183823","WHO|Registry Identifier: JapicCTI","Confirmed Objective Response Rate (ORR) in the Main Cohort of the Expansion Part","ORR is defined the percentage of the participants who are confirmed to have achieved complete response (CR) or partial response (PR) per an Independent Review Committee (IRC) using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 after the initiation of study treatment.","Up to 23 months","Confirmed ORR in the Overall Population of the Expansion Part|Duration of Response (DOR) in the Main Cohort and in the Overall Population of the Expansion Part|Progression-Free Survival (PFS) in the Main Cohort and in the Overall Population of the Expansion Part|Disease Control Rate (DCR) in the Main Cohort and in the Overall Population of the Expansion Part|Time to Response in the Main Cohort and in the Overall Population of the Expansion Part|Overall Survival (OS) in the Main Cohort and in the Overall Population of the Expansion Part|Central Nervous System (CNS) Response in the Main Cohort and in the Overall Population of the Expansion Part|Time on Treatment in the Main Cohort and in the Overall Population of the Expansion Part|Confirmed ORR in the Main Cohort of the Expansion Part|Patient-Reported Outcomes (PROs) of Health-Related Quality of Life (HRQOL) Scores and Symptoms of Lung Cancer in the Main Cohort of the Expansion Part|Cmax: Maximum Observed Plasma Concentration for Brigatinib on Cycle 1 Days 1 and 22|tmax: Time of First Occurrence of Cmax for Brigatinib on Cycle 1 Days 1 and 22|AUC: Area under the Plasma Concentration-Time Curve for Brigatinib on Cycle 1 Days 1 and 22","Up to 41 months|DOR will be assessed by an IRC, per RECIST version 1.1. DOR is defined as the time between the first documentation of objective tumor response (CR or PR) and the first subsequent documentation of objective progressive disease (PD) or death due to any cause, whichever occurs first.|PFS will be assessed by an IRC, per RECIST version 1.1. PFS is defined as the time from the start of study treatment to the first documentation of objective PD or to death due to any cause, whichever occurs first.|DCR will be assessed by an IRC, per RECIST version 1.1. DCR is defined as the percentage of participants who are confirmed to have achieved CR or PR or have a best overall response of stable disease (SD), per RECIST version 1.1, for 6 weeks or more after initiation of study drug.|Time to response will be assessed by an IRC, per RECIST version 1.1. Time to response is defined as the time interval from the date of the first dose of study treatment until the initial observation of CR or PR for patients with confirmed CR/PR.|OS is the time from the start of study treatment to the date of death.|CNS response will be assessed by an IRC, per modified RECIST version 1.1 for assessment of intracranial efficacy. CNS response is defined as the percentage of the participants who have achieved CR or PR in the intracranial CNS per modified RECIST version 1.1 as evaluated by an IRC after the initiation of study treatment.|Time on treatment is the time interval from the first dose to the last dose of Brigatinib.|The percentage of participants who are confirmed to have achieved CR or PR per investigator using RECIST version 1.1 after the initiation of study treatment.|PROs of HRQOL scores and symptoms of lung cancer, assessed with European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30, its lung cancer module QLQ-LC13, and the 5-level version of EuroQol 5-dimensional questionnaire (EQ-5D-5L) which are related to patient health, symptoms, and problems. Participants will answer for these questionalries. EORTC-QLQ-C30 contains 28 questions (4-point scale where 1=Not at all|Pre-dose and at multiple time points (0.5, 1, 2, 4, 6, 8, 12, 24; up to 24 hrs) post-dose of Cycle 1 Days 1 and 22","Up to 41 months|best to 4=Very Much","medicalinformation@tpna.com","Takeda Study Registration Call Center",-5028,"Nagoya, Aichi, Japan Nagoya University HospitalNagoya, Aichi, Japan Fujita Health University HospitalToyoake, Aichi, Japan|Kashiwa, Chiba, Japan|Chiba, Japan Kyushu University HospitalFukuoka, Japan National Hospital Organization Kyushu Cancer CenterFukuoka, Japan Kyoto University HospitalKyoto, Japan Niigata Cancer Center HospitalNiigata, Japan Okayama University HospitalOkayama, Japan Osaka City General HosupitalOsaka, Japan Osaka International Cancer InstituteOsaka, Japan Wakayama Medical University HospitalWakayama, Japan|Matsuyama, Ehime, Japan|Kurume, Fukuoka, Japan|Sapporo, Hokkaido, Japan|Akashi, Hyogo, Japan Kobe City Medical Center General HospitalKobe, Hyogo, Japan|Kanazawa, Ishikawa, Japan|Morioka, Iwate, Japan|Yokohama, Kanagawa, Japan|Matsuzaka, Mie, Japan|[Active, Not Recruiting]Sendai, Miyagi, Japan|Kurashiki, Okayama, Japan|Hirakata, Osaka, Japan Kindai University HospitalOsakasayama, Osaka, Japan|Ina, Saitama, Japan|Nagaizumi-Cho, Shizuoka, Japan|Shimotsuke, Tochigi, Japan|Bunkyo-Ku, Tokyo, Japan Tokyo Metropolitan Cancer And Infectious Diseases Center Komagome HospitalBunkyo-Ku, Tokyo, Japan National Cancer Center HospitalChuo-Ku, Tokyo, Japan Cancer Institute Hospital[Active, Not Recruiting]Koto-Ku, Tokyo, Japan",null,"Japan","Aichi Aichi Cancer Center Hospital|Chiba National Cancer Center Hospital East|Chiba University Hospital|Ehime National Hospital Organization Shikoku Cancer Center|Fukuoka Kurume University Hospital|Hokkaido Hokkaido Cancer Center|Hyogo Hyogo Cancer Center|Ishikawa Kanazawa University Hospital|Iwate Iwate Medical University Hospital|Kanagawa Kanagawa Cancer Center|Mie Matsuzaka Citizen's Hospital|Miyagi Sendai Kousei Hospital|Okayama Kurashiki Central Hospital|Osaka Kansai Medical University Hospital|Saitama Saitama Cancer Center|Shizuoka Shizuoka Cancer Center|Tochigi Jichi Medical University Hospital|Tokyo Juntendo University Hospital",{"$nulls":3},"Study Director","2018-08-29","2020-05-25T16:38:38.296","2020-05-26T17:10:42.972","NCT03410108"]
["5ecbf48ee2561b1b11905e3d","NCT03410108","2018-12-03","Takeda","TAK","Recruiting","Phase 2 Study of Brigatinib in Japanese Patients With ALK-Positive Non-Small Cell Lung Cancer (NSCLC)","Brigatinib","TK Inhibitor|ALK Inhibitor","No",null,"No",null,"Phase 2",1,80,"Anticipated","2018-01-17","2019-12-31","RR","Response Rate",{"$nulls":3},"The purpose of this study is to evaluate efficacy and safety of Brigatinib in Japanese patients with anaplastic lymphoma kinase (ALK)-positive NSCLC that has progressed after 1 or 2 lines of prior ALK inhibitor therapy.","The drug being tested in this study is called brigatinib. Brigatinib is being tested in patients with ALK-positive NSCLC in order to evaluate efficacy and safety of oral doses of brigatinib in Japanese patients with ALK-positive NSCLC.\n\nThe study will enroll approximately 80 participants. Participants will be enrolled in non-randomized and opened manner:\n\n- Brigatinib 90 mg for the first 7 days, followed by Brigatinib 180 mg of Brigatinib tablets, once daily in a 28-days cycle.\n\nAll participants will be asked to take tablets of brigatinib once daily with or without food throughout the study.\n\nThis multi-center trial will be conducted in Japan. The overall time to participate in this study is approximately 41 months. Participants will make multiple visits to the clinic during the treatment period, and posttreatment period including a follow-up assessment after last dose of study drug.","A Single-Arm, Multicenter, Phase 2 Study of Brigatinib in Japanese Patients With ALK-Positive Non-Small Cell Lung Cancer (NSCLC)","Brigatinib-2001","ALK-positive Advanced NSCLC","Non-Small-Cell Lung Cancer","Oncology Solid Tumor","Oncology","Experimental","Brigatinib 90 mg + Brigatinib 180 mg","90 mg of Brigatinib tablets, once daily for 7 days, followed by 180 mg of Brigatinib tablets, once daily in a 28-days cycle.","Drug","Brigatinib","Brigatinib tablet",null,"Brigatinib 90 mg + Brigatinib 180 mg","\n\n 1.  Male or female Japanese patients aged >=20 years on the day of consent.\n 2.  Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.\n 3.  Have histologically or cytologically confirmed stage IIIB, stage IIIC (locally advanced or recurrent and not a candidate for definitive multimodality therapy), or stage IV NSCLC.\n 4.  Must meet 1 of the following 2 criteria: 1. Have documentation of ALK rearrangement by a positive result from the Vysis ALK Break Apart FISH [fluorescence in situ hybridization] Probe Kit, the Nichirei Histofine ALK iAEP Kit, or the Ventana ALK (D5F3) CDx Assay at any time during prior disease course.\n      2. Had a documented ALK rearrangement by a different test at any time during prior disease course, and adequate tissue available for central laboratory testing by the Vysis ALK Break Apart FISH test. Central confirmation of ALK rearrangement is not required before enrollment.\n     \n     \n 5.  The expansion part only: had documented progressive disease (PD) during treatment or within 30 days discontinuation of treatment with ALK inhibitor. * Note 1: The expansion part consists of the main cohort and a subcohort based on prior ALK inhibitor treatment. The main cohort includes patients who had previously received alectinib (as their only ALK inhibitor) or both crizotinib and alectinib (regardless the sequence of those 2 ALK inhibitors), and a total of 47 patients will be enrolled. Patients with all other sequences of up to 2 prior ALK inhibitor(s) may be included in the subcohort, and the number of patients will be limited to 20.\n      * Note 2: Patients who will be included in the main cohort should have documented PD during treatment or within 30 days discontinuation of treatment with alectinib.\n     \n     \n 6.  Have at least 1 measurable (ie, target) lesion per RECIST version 1.1. Note: Previously irradiated lesions may not be used for target lesions, unless there is unambiguous radiological progression after radiotherapy. Brain lesions may not be used as target lesions if they were 1) previously treated with whole brain radiation therapy (WBRT) within 3 months, or 2) previously treated by stereotactic radiosurgery (SRS) or surgical resection.\n 7.  Recovered from toxicities related to prior anticancer therapy to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03 Grade =<1. Note: Treatment-related alopecia is allowed.\n 8.  Have a life expectancy of >=3 months.\n 9.  Have adequate organ and hematologic function, as determined by: 1. Both alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =<2.5 times the upper limit of the normal range (ULN) (=<5Ã—ULN is acceptable if liver metastases are present).\n      2. Total serum bilirubin =<1.5Ã—ULN (<3.0Ã—ULN for patients with Gilbert syndrome).\n      3. Serum creatinine <1.5Ã—ULN. For patients with creatinine levels above or equal to 1.5Ã—ULN, the patient is eligible if the estimated creatinine clearance using the Cockcroft-Gault formula is â‰¥30 mL/minute.\n      4. Serum lipase =<1.5Ã—ULN and serum amylase =<1.5Ã—ULN.\n      5. Absolute neutrophil count (ANC) >=1.5Ã—10^9/L.\n      6. Platelet count >=75Ã—10^9/L.\n      7. Hemoglobin >=9 g/dL.\n      8. Percutaneous oxygen saturation (SpO2) >=94% without oxygen support. Patients who need oxygen support are excluded.\n     \n     \n 10. Have an Eastern Cooperative Oncology Group (ECOG) performance status of =<2.\n 11. Must meet the following criteria: 1. Female patients who: * Are postmenopausal for at least 1 year before the screening visit, OR\n          * Are surgically sterile, OR\n          * If they are of childbearing potential, agree to practice 1 highly effective non-hormonal method of contraception and 1 additional effective (barrier) method at the same time, from the time of signing the informed consent through 4 months after the last dose of study drug, OR\n          * Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient, from the time of signing the informed consent through 4 months after that last dose of study drug. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together.)\n         \n         \n      2. Male patients, even if surgically sterilized (ie, status postvasectomy), who: * Agree to practice effective barrier contraception during the entire study treatment period and through 4 months after the last dose of study drug, OR\n          * Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient, during the entire study treatment period and through 4 months after that last dose of study drug. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together.)\n         \n         \n     \n     \n 12. Have the willingness and ability to comply with scheduled visit and study procedures.\n\n","\n\n 1.  Expansion part only: received any prior not specified ALK inhibitor.\n 2.  Expansion part only: received more than 2 prior ALK inhibitors. Note: The safety evaluation lead-in part allows patients with any line of prior ALK inhibitor which includes treatment-naÃ¯ve patients; however, ALK inhibitor-naÃ¯ve patients may be enrolled after the confirmation of first 3 DLT evaluable patients to have no more than 1 DLT during Cycle 1 by investigator's judgement.\n 3.  Received ALK inhibitor within 7 days before the first dose of Brigatinib.\n 4.  Previously received more than 1 regimen (more than 3 regimens in the safety evaluation lead-in part) of systemic anticancer therapy (not specified ALK inhibitor) for locally advanced or metastatic disease. Note: A systemic anticancer therapy regimen will be counted if it is administered over at least 1 cycle. A new anticancer agent used as maintenance therapy will be counted as a new regimen unless it was previously used as initial anticancer therapy. Neoadjuvant or adjuvant systemic anticancer therapy will be counted as a prior regimen if completion of (neo) adjuvant therapy occurred <12 months before the first dose of Brigatinib.\n 5.  Treatment with any investigational products except for specified ALK inhibitor within 30 days or 5 half-lives of that investigational agent, whichever is longer, before the first dose of Brigatinib.\n 6.  Received chemotherapy or radiation within 14 days before the first dose of brigatinib, except SRS or stereotactic body radiation therapy.\n 7.  Received antineoplastic monoclonal antibodies within 30 days before the first dose of brigatinib.\n 8.  Received systemic treatment with strong inhibitors or strong and moderate inducers of cytochrome P450 (CYP) 3A within 7 days before the first dose of brigatinib.\n 9.  Had major surgery within 30 days before the first dose of brigatinib. Minor surgical procedures such as venous catheter placement or minimally invasive biopsies are allowed.\n 10. Have been diagnosed with another primary malignancy other than NSCLC, except for the following adequately/definitively treated malignancies: nonmelanoma skin cancer, cervical cancer in situ, nonmetastatic prostate cancer; or patients with another primary malignancy who are definitively relapse-free with at least 3 years elapsed since the diagnosis of the other primary malignancy.\n 11. Have symptomatic central nervous system (CNS) metastases (parenchymal or leptomeningeal) at screening or asymptomatic disease requiring an increasing dose of corticosteroids to control symptoms within 7 days before the first dose of brigatinib. Note: If a patient has worsening neurological symptoms or signs due to CNS metastasis, the patient needs to complete local therapy and be neurologically stable (with no requirement for an increasing dose of corticosteroids or use of anticonvulsants for symptomatic control) for 7 days before the first dose of brigatinib.\n 12. Have current spinal cord compression (symptomatic or asymptomatic and detected by radiographic imaging). Patients with asymptomatic leptomeningeal disease and without cord compression are allowed.\n 13. Have ongoing or history of interstitial lung disease (ILD) (including interstitial pneumonitis, pneumonitis, radiation pneumonitis, drug-related pneumonitis, organized pneumonia, and pulmonary alveolitis).\n 14. Have significant, uncontrolled, or active cardiovascular disease, specifically including, but not limited to: 1. Myocardial infarction within 6 months before the first dose of brigatinib.\n      2. Unstable angina within 6 months before the first dose of brigatinib.\n      3. Congestive heart failure within 6 months before the first dose of brigatinib.\n      4. Uncontrolled atrial arrhythmias despite appropriate medical therapy.\n      5. History of ventricular arrhythmia, including history of ventricular tachycardia, ventricular fibrillation, or torsades de pointes. Patients with premature ventricular contractions are allowed.\n      6. Cerebrovascular accident or transient ischemic attack within 6 months before the first dose of brigatinib.\n      7. Resting heart rate <60 bpm.\n     \n     \n 15. Have uncontrolled hypertension. Patients with hypertension should be under treatment at the start of screening and demonstrate adequate control of blood pressure.\n 16. Have an ongoing or active infection, including, but not limited to, the requirement for intravenous antibiotics.\n 17. Have a known history of HIV infection. Testing is not required in the absence of history.\n 18. Hepatitis B surface antigen (HBsAg) positive, detectable hepatitis B viral load, or detectable hepatitis C virus (HCV) infection viral load. Note: Patients who have positive hepatitis B core antibody (HBcAb) or hepatitis B surface antibody (HBsAb) can be enrolled but must have an undetectable hepatitis B viral load. Patients who have positive HCV antibody can be enrolled but must have an undetectable hepatitis C viral load.\n 19. Have malabsorption syndrome or other gastrointestinal illness that could affect oral absorption of brigatinib.\n 20. Have a known or suspected hypersensitivity to brigatinib or its excipients.\n 21. Female patients who are lactating and breastfeeding or have a positive serum pregnancy test during the screening period.\n 22. Have any condition or illness that, in the opinion of the investigator, would compromise patient safety or interfere with the evaluation of brigatinib.",{"$nulls":4},"Actual","2018-01-25","Actual","Anticipated","2020-04-30","Anticipated","2018-11-01","2018-01-11","2018-01-23","2018-11-30","No",null,"Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","20 Years",null,"All",null,"No","Yes",{"$nulls":3},"Yes","No",{"$nulls":4},"Yes",{"$nulls":12},"U1111-1204-8752|JapicCTI-183823","WHO|Registry Identifier: JapicCTI","Confirmed Objective Response Rate (ORR) in the Main Cohort of the Expansion Part","ORR is defined the percentage of the participants who are confirmed to have achieved complete response (CR) or partial response (PR) per an Independent Review Committee (IRC) using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 after the initiation of study treatment.","Up to 23 months","Confirmed ORR in the Overall Population of the Expansion Part|Duration of Response (DOR) in the Main Cohort and in the Overall Population of the Expansion Part|Progression-Free Survival (PFS) in the Main Cohort and in the Overall Population of the Expansion Part|Disease Control Rate (DCR) in the Main Cohort and in the Overall Population of the Expansion Part|Time to Response in the Main Cohort and in the Overall Population of the Expansion Part|Overall Survival (OS) in the Main Cohort and in the Overall Population of the Expansion Part|Central Nervous System (CNS) Response in the Main Cohort and in the Overall Population of the Expansion Part|Time on Treatment in the Main Cohort and in the Overall Population of the Expansion Part|Confirmed ORR in the Main Cohort of the Expansion Part|Patient-Reported Outcomes (PROs) of Health-Related Quality of Life (HRQOL) Scores and Symptoms of Lung Cancer in the Main Cohort of the Expansion Part|Cmax: Maximum Observed Plasma Concentration for Brigatinib on Cycle 1 Days 1 and 22|tmax: Time of First Occurrence of Cmax for Brigatinib on Cycle 1 Days 1 and 22|AUC: Area under the Plasma Concentration-Time Curve for Brigatinib on Cycle 1 Days 1 and 22","Up to 41 months|DOR will be assessed by an IRC, per RECIST version 1.1. DOR is defined as the time between the first documentation of objective tumor response (CR or PR) and the first subsequent documentation of objective progressive disease (PD) or death due to any cause, whichever occurs first.|PFS will be assessed by an IRC, per RECIST version 1.1. PFS is defined as the time from the start of study treatment to the first documentation of objective PD or to death due to any cause, whichever occurs first.|DCR will be assessed by an IRC, per RECIST version 1.1. DCR is defined as the percentage of participants who are confirmed to have achieved CR or PR or have a best overall response of stable disease (SD), per RECIST version 1.1, for 6 weeks or more after initiation of study drug.|Time to response will be assessed by an IRC, per RECIST version 1.1. Time to response is defined as the time interval from the date of the first dose of study treatment until the initial observation of CR or PR for patients with confirmed CR/PR.|OS is the time from the start of study treatment to the date of death.|CNS response will be assessed by an IRC, per modified RECIST version 1.1 for assessment of intracranial efficacy. CNS response is defined as the percentage of the participants who have achieved CR or PR in the intracranial CNS per modified RECIST version 1.1 as evaluated by an IRC after the initiation of study treatment.|Time on treatment is the time interval from the first dose to the last dose of Brigatinib.|The percentage of participants who are confirmed to have achieved CR or PR per investigator using RECIST version 1.1 after the initiation of study treatment.|PROs of HRQOL scores and symptoms of lung cancer, assessed with European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30, its lung cancer module QLQ-LC13, and the 5-level version of EuroQol 5-dimensional questionnaire (EQ-5D-5L) which are related to patient health, symptoms, and problems. Participants will answer for these questionalries. EORTC-QLQ-C30 contains 28 questions (4-point scale where 1=Not at all|Pre-dose and at multiple time points (0.5, 1, 2, 4, 6, 8, 12, 24; up to 24 hrs) post-dose of Cycle 1 Days 1 and 22","Up to 41 months|best to 4=Very Much","medicalinformation@tpna.com","Takeda Study Registration Call Center",-5028,"Nagoya, Aichi, Japan Nagoya University HospitalNagoya, Aichi, Japan Fujita Health University HospitalToyoake, Aichi, Japan|Kashiwa, Chiba, Japan|Chiba, Japan Kyushu University HospitalFukuoka, Japan National Hospital Organization Kyushu Cancer CenterFukuoka, Japan Kyoto University HospitalKyoto, Japan Niigata Cancer Center HospitalNiigata, Japan Okayama University HospitalOkayama, Japan Osaka City General HospitalOsaka, Japan Osaka International Cancer InstituteOsaka, Japan Wakayama Medical University HospitalWakayama, Japan|Matsuyama, Ehime, Japan|Kurume, Fukuoka, Japan|Sapporo, Hokkaido, Japan|Akashi, Hyogo, Japan Kobe City Medical Center General HospitalKobe, Hyogo, Japan|Kanazawa, Ishikawa, Japan|Morioka, Iwate, Japan|Yokohama, Kanagawa, Japan|Matsuzaka, Mie, Japan|[Active, Not Recruiting]Sendai, Miyagi, Japan|Kurashiki, Okayama, Japan|Hirakata, Osaka, Japan Kindai University HospitalOsakasayama, Osaka, Japan|Ina, Saitama, Japan|Nagaizumi-Cho, Shizuoka, Japan|Shimotsuke, Tochigi, Japan|Bunkyo-Ku, Tokyo, Japan Tokyo Metropolitan Cancer And Infectious Diseases Center Komagome HospitalBunkyo-Ku, Tokyo, Japan National Cancer Center HospitalChuo-Ku, Tokyo, Japan Cancer Institute Hospital[Active, Not Recruiting]Koto-Ku, Tokyo, Japan",null,"Japan","Aichi Aichi Cancer Center Hospital|Chiba National Cancer Center Hospital East|Chiba University Hospital|Ehime National Hospital Organization Shikoku Cancer Center|Fukuoka Kurume University Hospital|Hokkaido Hokkaido Cancer Center|Hyogo Hyogo Cancer Center|Ishikawa Kanazawa University Hospital|Iwate Iwate Medical University Hospital|Kanagawa Kanagawa Cancer Center|Mie Matsuzaka Citizen's Hospital|Miyagi Sendai Kousei Hospital|Okayama Kurashiki Central Hospital|Osaka Kansai Medical University Hospital|Saitama Saitama Cancer Center|Shizuoka Shizuoka Cancer Center|Tochigi Jichi Medical University Hospital|Tokyo Juntendo University Hospital",{"$nulls":3},"Study Director","2018-11-30","2020-05-25T16:38:38.220","2020-05-26T17:10:42.972","NCT03410108"]
["5ecbf48efe30261b1a048344","NCT03410108","2019-01-14","Takeda","TAK","Recruiting","Phase 2 Study of Brigatinib in Japanese Patients With ALK-Positive Non-Small Cell Lung Cancer (NSCLC)","Brigatinib","TK Inhibitor|ALK Inhibitor","No",null,"No",null,"Phase 2",1,110,"Anticipated","2018-01-29","2020-08-13","RR|PFS","Response Rate|Progression Free Survival",{"$nulls":3},"The purpose of this study is to evaluate efficacy and safety of Brigatinib in Japanese patients with anaplastic lymphoma kinase (ALK)-positive NSCLC.","The drug being tested in this study is called brigatinib. Brigatinib is being tested in patients with ALK-positive NSCLC in order to evaluate efficacy and safety of oral doses of brigatinib in Japanese patients with ALK-positive NSCLC.\n\nThe study will enroll approximately 110 participants. Participants will be enrolled in non-randomized and opened manner:\n\n- Brigatinib 90 mg for the first 7 days, followed by Brigatinib 180 mg of Brigatinib tablets, once daily in a 28-days cycle.\n\nAll participants will be asked to take tablets of brigatinib once daily with or without food throughout the study.\n\nThis multi-center trial will be conducted in Japan. The overall time to participate in this study is approximately 53 months. Participants will make multiple visits to the clinic during the treatment period, and posttreatment period including a follow-up assessment after last dose of study drug.","A Single-Arm, Multicenter, Phase 2 Study of Brigatinib in Japanese Patients With ALK-Positive Non-Small Cell Lung Cancer (NSCLC)","Brigatinib-2001","ALK-positive Advanced NSCLC","Non-Small-Cell Lung Cancer","Oncology Solid Tumor","Oncology","Experimental","Brigatinib 90 mg + Brigatinib 180 mg","90 mg of Brigatinib tablets, once daily for 7 days, followed by 180 mg of Brigatinib tablets, once daily in a 28-days cycle.","Drug","Brigatinib","Brigatinib tablet",null,"Brigatinib 90 mg + Brigatinib 180 mg","\n\n 1.  Male or female Japanese patients aged >=20 years on the day of consent.\n 2.  Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.\n 3.  Have histologically or cytologically confirmed stage IIIB, stage IIIC (locally advanced or recurrent and not a candidate for definitive multimodality therapy), or stage IV NSCLC.\n 4.  Have documentation of ALK rearrangement that meets following criteria.For the safety evaluation lead-in part and the refractory expansion part, patients must meet 1 of the following 2 criteria:\n     \n      1. Have documentation of ALK rearrangement by a positive result from the Vysis ALK Break Apart FISH [fluorescence in situ hybridization] Probe Kit, the Nichirei Histofine ALK iAEP Kit, or the Ventana ALK (D5F3) CDx Assay at any time during prior disease course. The sponsor may require an adequate tissue available for central laboratory testing by the Vysis ALK Break Apart FISH test if a documented ALK rearrangement is confirmed by a positive result from the Nichirei Histofine ALK iAEP Kit \"ONLY\".\n      2. Had a documented ALK rearrangement by a different test at any time during prior disease course, and adequate tissue available for central laboratory testing by the Vysis ALK Break Apart FISH test. Central confirmation of ALK rearrangement is not required before enrollment.\n     \n     For TKI-naÃ¯ve expansion cohort, patients must meet the following criteria Have documentation of ALK rearrangement by a positive result from MHLW Approved tests (e.g Vysis ALK Break Apart FISH Probe Kit, the Nichirei Histofine ALK iAEP Kit, or the Ventana ALK [D5F3] CDx Assay) prior to enrollment, and required to submit sufficient tumor tissue for central laboratory testing upon request of sponsor. Central confirmation of ALK rearrangement is not required before enrollment\n     \n     \n 5.  The refractory expansion part only: had documented progressive disease (PD) during treatment or within 30 days after discontinuation of treatment with ALK inhibitor. * Note 1: The refractory expansion part consists of the main cohort and a subcohort based on prior ALK inhibitor treatment. The main cohort includes patients who had previously received alectinib (as their only ALK inhibitor) or both crizotinib and alectinib (regardless the sequence of those 2 ALK inhibitors), and a total of 47 patients will be enrolled. Patients with all other sequences of up to 2 prior ALK inhibitor(s) may be included in the subcohort, and the number of patients will be limited to 20.\n      * Note 2: Patients who will be included in the main cohort of the refractory should have documented PD during treatment or within 30 days after discontinuation of treatment with alectinib.\n     \n     \n 6.  Have at least 1 measurable (ie, target) lesion per RECIST version 1.1. Note: Previously irradiated lesions may not be used for target lesions, unless there is unambiguous radiological progression after radiotherapy. Brain lesions may not be used as target lesions if they were 1) previously treated with whole brain radiation therapy (WBRT) within 3 months, or 2) previously treated by stereotactic radiosurgery (SRS) or surgical resection.\n 7.  Recovered from toxicities related to prior anticancer therapy to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03 Grade =<1. Note: Treatment-related alopecia is allowed.\n 8.  Have a life expectancy of >=3 months.\n 9.  Have adequate organ and hematologic function, as determined by: 1. Both alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =<2.5 times the upper limit of the normal range (ULN) (=<5Ã—ULN is acceptable if liver metastases are present).\n      2. Total serum bilirubin =<1.5Ã—ULN (<3.0Ã—ULN for patients with Gilbert syndrome).\n      3. Serum creatinine <1.5Ã—ULN. For patients with creatinine levels above or equal to 1.5Ã—ULN, the patient is eligible if the estimated creatinine clearance using the Cockcroft-Gault formula is >=30 mL/minute.\n      4. Serum lipase =<1.5Ã—ULN and serum amylase =<1.5Ã—ULN.\n      5. Absolute neutrophil count (ANC) >=1.5Ã—10^9/L.\n      6. Platelet count >=75Ã—10^9/L.\n      7. Hemoglobin >=9 g/dL.\n      8. Percutaneous oxygen saturation (SpO2) >=94% without oxygen support. Patients who need oxygen support are excluded.\n     \n     \n 10. Have an Eastern Cooperative Oncology Group (ECOG) performance status of =<2.\n 11. Must meet the following criteria: 1. Female patients who: * Are postmenopausal for at least 1 year before the screening visit, OR\n          * Are surgically sterile, OR\n          * If they are of childbearing potential, agree to practice 1 highly effective non-hormonal method of contraception and 1 additional effective (barrier) method at the same time, from the time of signing the informed consent through 4 months after the last dose of study drug, OR\n          * Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient, from the time of signing the informed consent through 4 months after that last dose of study drug. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together.)\n         \n         \n      2. Male patients, even if surgically sterilized (ie, status postvasectomy), who: * Agree to practice effective barrier contraception during the entire study treatment period and through 4 months after the last dose of study drug, OR\n          * Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient, during the entire study treatment period and through 4 months after that last dose of study drug. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together.)\n         \n         \n     \n     \n 12. Have the willingness and ability to comply with scheduled visit and study procedures.\n\n","\n\n 1.  Previously received the following treatments. The refractory expansion part only: received any prior ALK inhibitor not specified in the protocol.TKI-naÃ¯ve expansion cohort only: received any prior TKI including but not limited to ALK inhibitor and VEGFR TKI.\n     \n     \n 2.  The refractory expansion part only: received more than 2 prior ALK inhibitors. Note: The safety evaluation lead-in part allows patients with any line of prior ALK inhibitor which includes treatment-naÃ¯ve patients; however, ALK inhibitor-naÃ¯ve patients may be enrolled after the confirmation of first 3 DLT evaluable patients to have no more than 1 DLT during Cycle 1 by investigator's judgement.\n 3.  The safety evaluation lead-in part and the refractory expansion part only: received ALK inhibitor within 7 days before the first dose of brigatinib.\n 4.  Previously received more than 1 regimen (more than 3 regimens in the safety evaluation lead-in part) of systemic anticancer therapy (other than ALK inhibitors) for locally advanced or metastatic disease. Note: A systemic anticancer therapy regimen will be counted if it is administered over at least 1 cycle. A new anticancer agent used as maintenance therapy will be counted as a new regimen unless it was previously used as initial anticancer therapy. Neoadjuvant or adjuvant systemic anticancer therapy will be counted as a prior regimen if completion of (neo) adjuvant therapy occurred <12 months before the first dose of brigatinib.\n 5.  Treatment with any investigational products within 30 days or 5 half-lives of that investigational agent, whichever is longer, before the first dose of brigatinib.\n 6.  Received chemotherapy or radiation within 14 days before the first dose of brigatinib, except SRS or stereotactic body radiation therapy.\n 7.  Received antineoplastic monoclonal antibodies within 30 days before the first dose of brigatinib.\n 8.  Received systemic treatment with strong inhibitors or strong and moderate inducers of cytochrome P450 (CYP) 3A within 7 days before the first dose of brigatinib.\n 9.  Had major surgery within 30 days before the first dose of brigatinib. Minor surgical procedures such as venous catheter placement or minimally invasive biopsies are allowed.\n 10. Have been diagnosed with another primary malignancy other than NSCLC, except for the following adequately/definitively treated malignancies: nonmelanoma skin cancer, cervical cancer in situ, nonmetastatic prostate cancer; or patients with another primary malignancy who are definitively relapse-free with at least 3 years elapsed since the diagnosis of the other primary malignancy.\n 11. Have symptomatic central nervous system (CNS) metastases (parenchymal or leptomeningeal) at screening or asymptomatic disease requiring an increasing dose of corticosteroids to control symptoms within 7 days before the first dose of brigatinib. Note: If a patient has worsening neurological symptoms or signs due to CNS metastasis, the patient needs to complete local therapy and be neurologically stable (with no requirement for an increasing dose of corticosteroids or use of anticonvulsants for symptomatic control) for 7 days before the first dose of brigatinib.\n 12. Have current spinal cord compression (symptomatic or asymptomatic and detected by radiographic imaging). Patients with asymptomatic leptomeningeal disease and without cord compression are allowed.\n 13. Have ongoing or history of interstitial lung disease (ILD) (including interstitial pneumonitis, pneumonitis, radiation pneumonitis, drug-related pneumonitis, organized pneumonia, and pulmonary alveolitis).\n 14. Have significant, uncontrolled, or active cardiovascular disease, specifically including, but not limited to: 1. Myocardial infarction within 6 months before the first dose of brigatinib.\n      2. Unstable angina within 6 months before the first dose of brigatinib.\n      3. Congestive heart failure within 6 months before the first dose of brigatinib.\n      4. Uncontrolled atrial arrhythmias despite appropriate medical therapy.\n      5. History of ventricular arrhythmia, including history of ventricular tachycardia, ventricular fibrillation, or torsades de pointes. Patients with premature ventricular contractions are allowed.\n      6. Cerebrovascular accident or transient ischemic attack within 6 months before the first dose of brigatinib.\n     \n     \n 15. Have uncontrolled hypertension. Patients with hypertension should be under treatment at the start of screening and demonstrate adequate control of blood pressure.\n 16. Have an ongoing or active infection, including, but not limited to, the requirement for intravenous antibiotics.\n 17. Have a known history of HIV infection. Testing is not required in the absence of history.\n 18. Hepatitis B surface antigen (HBsAg) positive, detectable hepatitis B viral load, or detectable hepatitis C virus (HCV) infection viral load. Note: Patients who have positive hepatitis B core antibody (HBcAb) or hepatitis B surface antibody (HBsAb) can be enrolled but must have an undetectable hepatitis B viral load. Patients who have positive HCV antibody can be enrolled but must have an undetectable hepatitis C viral load.\n 19. Have malabsorption syndrome or other gastrointestinal illness that could affect oral absorption of brigatinib.\n 20. Have a known or suspected hypersensitivity to brigatinib or its excipients.\n 21. Female patients who are lactating and breastfeeding or have a positive serum pregnancy test during the screening period. Note: Female patients who are lactating will be excluded, even if they discontinue breastfeeding.\n 22. Have any condition or illness that, in the opinion of the investigator, would compromise patient safety or interfere with the evaluation of brigatinib.",{"$nulls":4},"Actual","2018-01-25","Actual","Anticipated","2022-05-31","Anticipated","2019-01-01","2018-01-11","2018-01-23","2019-01-10","No",null,"Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","20 Years",null,"All",null,"No","Yes",{"$nulls":3},"Yes","No",{"$nulls":4},"Yes",{"$nulls":12},"U1111-1204-8752|JapicCTI-183823","WHO|Registry Identifier: JapicCTI","Confirmed Objective Response Rate (ORR) in the Main Cohort of the Refractory Expansion Part|12 Months Progression-Free Survival (PFS) Rate in the Tyrosine Kinase Inhibitor (TKI) NaÃ¯ve Expansion Cohort","ORR is defined the percentage of the participants who are confirmed to have achieved complete response (CR) or partial response (PR) per an Independent Review Committee (IRC) using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 after the initiation of study treatment.|12 months PFS rate is defined as the percentage of the participants who do not have PFS events (Progression disease","Up to 23 months|PD per IRC using RECIST version 1.1, or death by any cause) at 12 months after the start of study treatment.","Confirmed ORR in the TKI-naÃ¯ve Expansion Cohort, the Overall Population of the Refractory Expansion Part, and the Safety Evaluation Lead-in Part|Duration of Response (DOR) in the TKI-naÃ¯ve Expansion Cohort, the Main Cohort of the Refractory Expansion Part, and the Overall Population of the Refractory Expansion Part|Progression-Free Survival (PFS) in the TKI-naÃ¯ve Expansion Cohort, the Main Cohort of the Refractory Expansion Part, and the Overall Population of the Refractory Expansion Part|Disease Control Rate (DCR) in the TKI-naÃ¯ve Expansion Cohort, the Main Cohort of the Refractory Expansion Part, and the Overall Population of the Refractory Expansion Part|Time to Response in the TKI-naÃ¯ve Expansion Cohort, the Main Cohort of the Refractory Expansion Part, and the Overall Population of the Refractory Expansion Part|Overall Survival (OS) in the TKI-naÃ¯ve Expansion Cohort, the Main Cohort of the Refractory Expansion Part, and the Overall Population of the Refractory Expansion Part|Central Nervous System (CNS) Response in the TKI-naÃ¯ve Expansion Cohort, the Main Cohort of the Refractory Expansion Part, and the Overall Population of the Refractory Expansion Part|Time on Treatment in the TKI-naÃ¯ve Expansion Cohort, the Main Cohort of the Refractory Expansion Part, and the Overall Population of the Refractory Expansion Part|Confirmed ORR in the TKI-naÃ¯ve Expansion Cohort, the Main Cohort of the Refractory Expansion Part, and the Safety Evaluation Lead-in Part|Patient-Reported Outcomes (PROs) of Health-Related Quality of Life (HRQOL) Scores and Symptoms of Lung Cancer in the TKI-naÃ¯ve Expansion Cohort, the Main Cohort of the Refractory Expansion Part, and the Safety Evaluation Lead-in Part|Cmax: Maximum Observed Plasma Concentration for Brigatinib on Cycle 1 Days 1 and 22|tmax: Time of First Occurrence of Cmax for Brigatinib on Cycle 1 Days 1 and 22|AUC: Area under the Plasma Concentration-Time Curve for Brigatinib on Cycle 1 Days 1 and 22","Up to 53 months|DOR will be assessed by an IRC, per RECIST version 1.1. DOR is defined as the time between the first documentation of objective tumor response (CR or PR) and the first subsequent documentation of objective progressive disease (PD) or death due to any cause, whichever occurs first.|PFS will be assessed by an IRC, per RECIST version 1.1. PFS is defined as the time from the start of study treatment to the first documentation of objective PD or to death due to any cause, whichever occurs first.|DCR will be assessed by an IRC, per RECIST version 1.1. DCR is defined as the percentage of participants who are confirmed to have achieved CR or PR or have a best overall response of stable disease (SD), per RECIST version 1.1, for 6 weeks or more after initiation of study drug.|Time to response will be assessed by an IRC, per RECIST version 1.1. Time to response is defined as the time interval from the date of the first dose of study treatment until the initial observation of CR or PR for patients with confirmed CR/PR.|OS is the time from the start of study treatment to the date of death.|CNS response will be assessed by an IRC, per modified RECIST version 1.1 for assessment of intracranial efficacy (intracranial objective response rate|Time on treatment is the time interval from the first dose to the last dose of Brigatinib.|The percentage of participants who are confirmed to have achieved CR or PR per investigator using RECIST version 1.1 after the initiation of study treatment.|PROs of HRQOL scores and symptoms of lung cancer, assessed with European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30, its lung cancer module QLQ-LC13, and the 5-level version of EuroQol 5-dimensional questionnaire (EQ-5D-5L) which are related to patient health, symptoms, and problems. Participants will answer for these questionalries. EORTC-QLQ-C30 contains 28 questions (4-point scale where 1=Not at all|Pre-dose and at multiple time points (0.5, 1, 2, 4, 6, 8, 12, 24; up to 24 hrs) post-dose of Cycle 1 Days 1 and 22","Up to 53 months|iORR and duration of intracranial response|best to 4=Very Much","medicalinformation@tpna.com","Takeda Study Registration Call Center",-5028,"Nagoya, Aichi, Japan Nagoya University HospitalNagoya, Aichi, Japan Fujita Health University HospitalToyoake, Aichi, Japan|Kashiwa, Chiba, Japan|Chiba, Japan Kyushu University HospitalFukuoka, Japan National Hospital Organization Kyushu Cancer CenterFukuoka, Japan Kyoto University HospitalKyoto, Japan Niigata Cancer Center HospitalNiigata, Japan Okayama University HospitalOkayama, Japan Osaka City General HospitalOsaka, Japan Osaka International Cancer InstituteOsaka, Japan Wakayama Medical University HospitalWakayama, Japan|Matsuyama, Ehime, Japan|Kurume, Fukuoka, Japan|Sapporo, Hokkaido, Japan|Akashi, Hyogo, Japan Kobe City Medical Center General HospitalKobe, Hyogo, Japan|Kanazawa, Ishikawa, Japan|Morioka, Iwate, Japan|Yokohama, Kanagawa, Japan|Matsuzaka, Mie, Japan|[Active, Not Recruiting]Sendai, Miyagi, Japan|Kurashiki, Okayama, Japan|Hirakata, Osaka, Japan Kindai University HospitalOsakasayama, Osaka, Japan|Ina, Saitama, Japan|Nagaizumi-Cho, Shizuoka, Japan|Shimotsuke, Tochigi, Japan|Bunkyo-Ku, Tokyo, Japan Tokyo Metropolitan Cancer And Infectious Diseases Center Komagome HospitalBunkyo-Ku, Tokyo, Japan National Cancer Center HospitalChuo-Ku, Tokyo, Japan Cancer Institute Hospital[Active, Not Recruiting]Koto-Ku, Tokyo, Japan",null,"Japan","Aichi Aichi Cancer Center Hospital|Chiba National Cancer Center Hospital East|Chiba University Hospital|Ehime National Hospital Organization Shikoku Cancer Center|Fukuoka Kurume University Hospital|Hokkaido Hokkaido Cancer Center|Hyogo Hyogo Cancer Center|Ishikawa Kanazawa University Hospital|Iwate Iwate Medical University Hospital|Kanagawa Kanagawa Cancer Center|Mie Matsuzaka Citizen's Hospital|Miyagi Sendai Kousei Hospital|Okayama Kurashiki Central Hospital|Osaka Kansai Medical University Hospital|Saitama Saitama Cancer Center|Shizuoka Shizuoka Cancer Center|Tochigi Jichi Medical University Hospital|Tokyo Juntendo University Hospital",{"$nulls":3},"Study Director","2019-01-10","2020-05-25T16:38:38.464","2020-05-26T17:10:42.972","NCT03410108"]
["5ecbf48ee2561b1b11905e3e","NCT03410108","2019-04-29","Takeda","TAK","Recruiting","Phase 2 Study of Brigatinib in Japanese Patients With ALK-Positive Non-Small Cell Lung Cancer (NSCLC)","Brigatinib","TK Inhibitor|ALK Inhibitor","No",null,"No",null,"Phase 2",1,110,"Anticipated","2018-01-29","2020-08-13","RR|PFS","Response Rate|Progression Free Survival",{"$nulls":3},"The purpose of this study is to evaluate efficacy and safety of Brigatinib in Japanese patients with anaplastic lymphoma kinase (ALK)-positive NSCLC.","The drug being tested in this study is called brigatinib. Brigatinib is being tested in patients with ALK-positive NSCLC in order to evaluate efficacy and safety of oral doses of brigatinib in Japanese patients with ALK-positive NSCLC.\n\nThe study will enroll approximately 110 participants. Participants will be enrolled in non-randomized and opened manner:\n\n- Brigatinib 90 mg for the first 7 days, followed by Brigatinib 180 mg of Brigatinib tablets, once daily in a 28-days cycle.\n\nAll participants will be asked to take tablets of brigatinib once daily with or without food throughout the study.\n\nThis multi-center trial will be conducted in Japan. The overall time to participate in this study is approximately 53 months. Participants will make multiple visits to the clinic during the treatment period, and posttreatment period including a follow-up assessment after last dose of study drug.","A Single-Arm, Multicenter, Phase 2 Study of Brigatinib in Japanese Patients With ALK-Positive Non-Small Cell Lung Cancer (NSCLC)","Brigatinib-2001","ALK-positive Advanced NSCLC","Non-Small-Cell Lung Cancer","Oncology Solid Tumor","Oncology","Experimental","Brigatinib 90 mg + Brigatinib 180 mg","90 mg of Brigatinib tablets, once daily for 7 days, followed by 180 mg of Brigatinib tablets, once daily in a 28-days cycle.","Drug","Brigatinib","Brigatinib tablet",null,"Brigatinib 90 mg + Brigatinib 180 mg","\n\n 1.  Male or female Japanese patients aged >=20 years on the day of consent.\n 2.  Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.\n 3.  Have histologically or cytologically confirmed stage IIIB, stage IIIC (locally advanced or recurrent and not a candidate for definitive multimodality therapy), or stage IV NSCLC.\n 4.  Have documentation of ALK rearrangement that meets following criteria.For the safety evaluation lead-in part and the refractory expansion part, patients must meet 1 of the following 2 criteria:\n     \n      1. Have documentation of ALK rearrangement by a positive result from the Vysis ALK Break Apart FISH [fluorescence in situ hybridization] Probe Kit, the Nichirei Histofine ALK iAEP Kit, or the Ventana ALK (D5F3) CDx Assay at any time during prior disease course. The sponsor may require an adequate tissue available for central laboratory testing by the Vysis ALK Break Apart FISH test if a documented ALK rearrangement is confirmed by a positive result from the Nichirei Histofine ALK iAEP Kit \"ONLY\".\n      2. Had a documented ALK rearrangement by a different test at any time during prior disease course, and adequate tissue available for central laboratory testing by the Vysis ALK Break Apart FISH test. Central confirmation of ALK rearrangement is not required before enrollment.\n     \n     For TKI-naÃ¯ve expansion cohort, patients must meet the following criteria Have documentation of ALK rearrangement by a positive result from MHLW Approved tests (e.g Vysis ALK Break Apart FISH Probe Kit, the Nichirei Histofine ALK iAEP Kit, or the Ventana ALK [D5F3] CDx Assay) prior to enrollment, and required to submit sufficient tumor tissue for central laboratory testing upon request of sponsor. Central confirmation of ALK rearrangement is not required before enrollment\n     \n     \n 5.  The refractory expansion part only: had documented progressive disease (PD) during treatment or within 30 days after discontinuation of treatment with ALK inhibitor. * Note 1: The refractory expansion part consists of the main cohort and a subcohort based on prior ALK inhibitor treatment. The main cohort includes patients who had previously received alectinib (as their only ALK inhibitor) or both crizotinib and alectinib (regardless the sequence of those 2 ALK inhibitors), and a total of 47 patients will be enrolled. Patients with all other sequences of up to 2 prior ALK inhibitor(s) may be included in the subcohort, and the number of patients will be limited to 20.\n      * Note 2: Patients who will be included in the main cohort of the refractory should have documented PD during treatment or within 30 days after discontinuation of treatment with alectinib.\n     \n     \n 6.  Have at least 1 measurable (ie, target) lesion per RECIST version 1.1. Note: Previously irradiated lesions may not be used for target lesions, unless there is unambiguous radiological progression after radiotherapy. Brain lesions may not be used as target lesions if they were 1) previously treated with whole brain radiation therapy (WBRT) within 3 months, or 2) previously treated by stereotactic radiosurgery (SRS) or surgical resection.\n 7.  Recovered from toxicities related to prior anticancer therapy to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03 Grade =<1. Note: Treatment-related alopecia is allowed.\n 8.  Have a life expectancy of >=3 months.\n 9.  Have adequate organ and hematologic function, as determined by: 1. Both alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =<2.5 times the upper limit of the normal range (ULN) (=<5Ã—ULN is acceptable if liver metastases are present).\n      2. Total serum bilirubin =<1.5Ã—ULN (<3.0Ã—ULN for patients with Gilbert syndrome).\n      3. Serum creatinine <1.5Ã—ULN. For patients with creatinine levels above or equal to 1.5Ã—ULN, the patient is eligible if the estimated creatinine clearance using the Cockcroft-Gault formula is >=30 mL/minute.\n      4. Serum lipase =<1.5Ã—ULN and serum amylase =<1.5Ã—ULN.\n      5. Absolute neutrophil count (ANC) >=1.5Ã—10^9/L.\n      6. Platelet count >=75Ã—10^9/L.\n      7. Hemoglobin >=9 g/dL.\n      8. Percutaneous oxygen saturation (SpO2) >=94% without oxygen support. Patients who need oxygen support are excluded.\n     \n     \n 10. Have an Eastern Cooperative Oncology Group (ECOG) performance status of =<2.\n 11. Must meet the following criteria: 1. Female patients who: * Are postmenopausal for at least 1 year before the screening visit, OR\n          * Are surgically sterile, OR\n          * If they are of childbearing potential, agree to practice 1 highly effective non-hormonal method of contraception and 1 additional effective (barrier) method at the same time, from the time of signing the informed consent through 4 months after the last dose of study drug, OR\n          * Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient, from the time of signing the informed consent through 4 months after that last dose of study drug. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together.)\n         \n         \n      2. Male patients, even if surgically sterilized (ie, status postvasectomy), who: * Agree to practice effective barrier contraception during the entire study treatment period and through 4 months after the last dose of study drug, OR\n          * Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient, during the entire study treatment period and through 4 months after that last dose of study drug. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together.)\n         \n         \n     \n     \n 12. Have the willingness and ability to comply with scheduled visit and study procedures.\n\n","\n\n 1.  Previously received the following treatments. The refractory expansion part only: received any prior ALK inhibitor not specified in the protocol.TKI-naÃ¯ve expansion cohort only: received any prior TKI including but not limited to ALK inhibitor and VEGFR TKI.\n     \n     \n 2.  The refractory expansion part only: received more than 2 prior ALK inhibitors. Note: The safety evaluation lead-in part allows patients with any line of prior ALK inhibitor which includes treatment-naÃ¯ve patients; however, ALK inhibitor-naÃ¯ve patients may be enrolled after the confirmation of first 3 DLT evaluable patients to have no more than 1 DLT during Cycle 1 by investigator's judgement.\n 3.  The safety evaluation lead-in part and the refractory expansion part only: received ALK inhibitor within 7 days before the first dose of brigatinib.\n 4.  Previously received more than 1 regimen (more than 3 regimens in the safety evaluation lead-in part) of systemic anticancer therapy (other than ALK inhibitors) for locally advanced or metastatic disease. Note: A systemic anticancer therapy regimen will be counted if it is administered over at least 1 cycle. A new anticancer agent used as maintenance therapy will be counted as a new regimen unless it was previously used as initial anticancer therapy. Neoadjuvant or adjuvant systemic anticancer therapy will be counted as a prior regimen if completion of (neo) adjuvant therapy occurred <12 months before the first dose of brigatinib.\n 5.  Treatment with any investigational products within 30 days or 5 half-lives of that investigational agent, whichever is longer, before the first dose of brigatinib.\n 6.  Received chemotherapy or radiation within 14 days before the first dose of brigatinib, except SRS or stereotactic body radiation therapy.\n 7.  Received antineoplastic monoclonal antibodies within 30 days before the first dose of brigatinib.\n 8.  Received systemic treatment with strong inhibitors or strong and moderate inducers of cytochrome P450 (CYP) 3A within 7 days before the first dose of brigatinib.\n 9.  Had major surgery within 30 days before the first dose of brigatinib. Minor surgical procedures such as venous catheter placement or minimally invasive biopsies are allowed.\n 10. Have been diagnosed with another primary malignancy other than NSCLC, except for the following adequately/definitively treated malignancies: nonmelanoma skin cancer, cervical cancer in situ, nonmetastatic prostate cancer; or patients with another primary malignancy who are definitively relapse-free with at least 3 years elapsed since the diagnosis of the other primary malignancy.\n 11. Have symptomatic central nervous system (CNS) metastases (parenchymal or leptomeningeal) at screening or asymptomatic disease requiring an increasing dose of corticosteroids to control symptoms within 7 days before the first dose of brigatinib. Note: If a patient has worsening neurological symptoms or signs due to CNS metastasis, the patient needs to complete local therapy and be neurologically stable (with no requirement for an increasing dose of corticosteroids or use of anticonvulsants for symptomatic control) for 7 days before the first dose of brigatinib.\n 12. Have current spinal cord compression (symptomatic or asymptomatic and detected by radiographic imaging). Patients with asymptomatic leptomeningeal disease and without cord compression are allowed.\n 13. Have ongoing or history of interstitial lung disease (ILD) (including interstitial pneumonitis, pneumonitis, radiation pneumonitis, drug-related pneumonitis, organized pneumonia, and pulmonary alveolitis).\n 14. Have significant, uncontrolled, or active cardiovascular disease, specifically including, but not limited to: 1. Myocardial infarction within 6 months before the first dose of brigatinib.\n      2. Unstable angina within 6 months before the first dose of brigatinib.\n      3. Congestive heart failure within 6 months before the first dose of brigatinib.\n      4. Uncontrolled atrial arrhythmias despite appropriate medical therapy.\n      5. History of ventricular arrhythmia, including history of ventricular tachycardia, ventricular fibrillation, or torsades de pointes. Patients with premature ventricular contractions are allowed.\n      6. Cerebrovascular accident or transient ischemic attack within 6 months before the first dose of brigatinib.\n     \n     \n 15. Have uncontrolled hypertension. Patients with hypertension should be under treatment at the start of screening and demonstrate adequate control of blood pressure.\n 16. Have an ongoing or active infection, including, but not limited to, the requirement for intravenous antibiotics.\n 17. Have a known history of HIV infection. Testing is not required in the absence of history.\n 18. Hepatitis B surface antigen (HBsAg) positive, detectable hepatitis B viral load, or detectable hepatitis C virus (HCV) infection viral load. Note: Patients who have positive hepatitis B core antibody (HBcAb) or hepatitis B surface antibody (HBsAb) can be enrolled but must have an undetectable hepatitis B viral load. Patients who have positive HCV antibody can be enrolled but must have an undetectable hepatitis C viral load.\n 19. Have malabsorption syndrome or other gastrointestinal illness that could affect oral absorption of brigatinib.\n 20. Have a known or suspected hypersensitivity to brigatinib or its excipients.\n 21. Female patients who are lactating and breastfeeding or have a positive serum pregnancy test during the screening period. Note: Female patients who are lactating will be excluded, even if they discontinue breastfeeding.\n 22. Have any condition or illness that, in the opinion of the investigator, would compromise patient safety or interfere with the evaluation of brigatinib.",{"$nulls":4},"Actual","2018-01-25","Actual","Anticipated","2022-05-31","Anticipated","2019-04-01","2018-01-11","2018-01-23","2019-04-26","No",null,"Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","20 Years",null,"All",null,"No","Yes",{"$nulls":3},"Yes","No",{"$nulls":4},"Yes",{"$nulls":12},"U1111-1204-8752|JapicCTI-183823","WHO|Registry Identifier: JapicCTI","Confirmed Objective Response Rate (ORR) in the Main Cohort of the Refractory Expansion Part|12 Months Progression-Free Survival (PFS) Rate in the Tyrosine Kinase Inhibitor (TKI) NaÃ¯ve Expansion Cohort","ORR is defined the percentage of the participants who are confirmed to have achieved complete response (CR) or partial response (PR) per an Independent Review Committee (IRC) using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 after the initiation of study treatment.|12 months PFS rate is defined as the percentage of the participants who do not have PFS events (Progression disease","Up to 23 months|PD per IRC using RECIST version 1.1, or death by any cause) at 12 months after the start of study treatment.","Confirmed ORR in the TKI-naÃ¯ve Expansion Cohort, the Overall Population of the Refractory Expansion Part, and the Safety Evaluation Lead-in Part|Duration of Response (DOR) in the TKI-naÃ¯ve Expansion Cohort, the Main Cohort of the Refractory Expansion Part, and the Overall Population of the Refractory Expansion Part|Progression-Free Survival (PFS) in the TKI-naÃ¯ve Expansion Cohort, the Main Cohort of the Refractory Expansion Part, and the Overall Population of the Refractory Expansion Part|Disease Control Rate (DCR) in the TKI-naÃ¯ve Expansion Cohort, the Main Cohort of the Refractory Expansion Part, and the Overall Population of the Refractory Expansion Part|Time to Response in the TKI-naÃ¯ve Expansion Cohort, the Main Cohort of the Refractory Expansion Part, and the Overall Population of the Refractory Expansion Part|Overall Survival (OS) in the TKI-naÃ¯ve Expansion Cohort, the Main Cohort of the Refractory Expansion Part, and the Overall Population of the Refractory Expansion Part|Central Nervous System (CNS) Response in the TKI-naÃ¯ve Expansion Cohort, the Main Cohort of the Refractory Expansion Part, and the Overall Population of the Refractory Expansion Part|Time on Treatment in the TKI-naÃ¯ve Expansion Cohort, the Main Cohort of the Refractory Expansion Part, and the Overall Population of the Refractory Expansion Part|Confirmed ORR in the TKI-naÃ¯ve Expansion Cohort, the Main Cohort of the Refractory Expansion Part, and the Safety Evaluation Lead-in Part|Patient-Reported Outcomes (PROs) of Health-Related Quality of Life (HRQOL) Scores and Symptoms of Lung Cancer in the TKI-naÃ¯ve Expansion Cohort, the Main Cohort of the Refractory Expansion Part, and the Safety Evaluation Lead-in Part|Cmax: Maximum Observed Plasma Concentration for Brigatinib on Cycle 1 Days 1 and 22|tmax: Time of First Occurrence of Cmax for Brigatinib on Cycle 1 Days 1 and 22|AUC: Area under the Plasma Concentration-Time Curve for Brigatinib on Cycle 1 Days 1 and 22","Up to 53 months|DOR will be assessed by an IRC, per RECIST version 1.1. DOR is defined as the time between the first documentation of objective tumor response (CR or PR) and the first subsequent documentation of objective progressive disease (PD) or death due to any cause, whichever occurs first.|PFS will be assessed by an IRC, per RECIST version 1.1. PFS is defined as the time from the start of study treatment to the first documentation of objective PD or to death due to any cause, whichever occurs first.|DCR will be assessed by an IRC, per RECIST version 1.1. DCR is defined as the percentage of participants who are confirmed to have achieved CR or PR or have a best overall response of stable disease (SD), per RECIST version 1.1, for 6 weeks or more after initiation of study drug.|Time to response will be assessed by an IRC, per RECIST version 1.1. Time to response is defined as the time interval from the date of the first dose of study treatment until the initial observation of CR or PR for patients with confirmed CR/PR.|OS is the time from the start of study treatment to the date of death.|CNS response will be assessed by an IRC, per modified RECIST version 1.1 for assessment of intracranial efficacy (intracranial objective response rate|Time on treatment is the time interval from the first dose to the last dose of Brigatinib.|The percentage of participants who are confirmed to have achieved CR or PR per investigator using RECIST version 1.1 after the initiation of study treatment.|PROs of HRQOL scores and symptoms of lung cancer, assessed with European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30, its lung cancer module QLQ-LC13, and the 5-level version of EuroQol 5-dimensional questionnaire (EQ-5D-5L) which are related to patient health, symptoms, and problems. Participants will answer for these questionalries. EORTC-QLQ-C30 contains 28 questions (4-point scale where 1=Not at all|Pre-dose and at multiple time points (0.5, 1, 2, 4, 6, 8, 12, 24; up to 24 hrs) post-dose of Cycle 1 Days 1 and 22","Up to 53 months|iORR and duration of intracranial response|best to 4=Very Much","medicalinformation@tpna.com","Takeda Study Registration Call Center",-5028,"Nagoya, Aichi, Japan Nagoya University HospitalNagoya, Aichi, Japan Fujita Health University HospitalToyoake, Aichi, Japan|Kashiwa, Chiba, Japan|Chiba, Japan Kyushu University HospitalFukuoka, Japan National Hospital Organization Kyushu Cancer CenterFukuoka, Japan Kyoto University HospitalKyoto, Japan Niigata Cancer Center HospitalNiigata, Japan Okayama University HospitalOkayama, Japan Osaka City General HospitalOsaka, Japan Osaka International Cancer InstituteOsaka, Japan Wakayama Medical University HospitalWakayama, Japan|Matsuyama, Ehime, Japan|Kurume, Fukuoka, Japan|Sapporo, Hokkaido, Japan|Akashi, Hyogo, Japan Kobe City Medical Center General HospitalKobe, Hyogo, Japan|Kanazawa, Ishikawa, Japan|Morioka, Iwate, Japan|Yokohama, Kanagawa, Japan|Matsuzaka, Mie, Japan|Sendai, Miyagi, Japan|Kurashiki, Okayama, Japan|Hirakata, Osaka, Japan Kindai University HospitalOsakasayama, Osaka, Japan|Ina, Saitama, Japan|Nagaizumi-Cho, Shizuoka, Japan|Shimotsuke, Tochigi, Japan|Bunkyo-Ku, Tokyo, Japan Tokyo Metropolitan Cancer And Infectious Diseases Center Komagome HospitalBunkyo-Ku, Tokyo, Japan National Cancer Center Hospital[Active, Not Recruiting]Chuo-Ku, Tokyo, Japan Cancer Institute HospitalKoto-Ku, Tokyo, Japan",null,"Japan","Aichi Aichi Cancer Center Hospital|Chiba National Cancer Center Hospital East|Chiba University Hospital|Ehime National Hospital Organization Shikoku Cancer Center|Fukuoka Kurume University Hospital|Hokkaido Hokkaido Cancer Center|Hyogo Hyogo Cancer Center|Ishikawa Kanazawa University Hospital|Iwate Iwate Medical University Hospital|Kanagawa Kanagawa Cancer Center|Mie Matsuzaka Citizen's Hospital|Miyagi Sendai Kousei Hospital|Okayama Kurashiki Central Hospital|Osaka Kansai Medical University Hospital|Saitama Saitama Cancer Center|Shizuoka Shizuoka Cancer Center|Tochigi Jichi Medical University Hospital|Tokyo Juntendo University Hospital",{"$nulls":3},"Study Director","2019-04-26","2020-05-25T16:38:38.710","2020-05-26T17:10:42.972","NCT03410108"]
["5ecbf48efe30261b1a048345","NCT03410108","2019-05-31","Takeda","TAK","Recruiting","Phase 2 Study of Brigatinib in Japanese Patients With ALK-Positive Non-Small Cell Lung Cancer (NSCLC)","Brigatinib","TK Inhibitor|ALK Inhibitor","No",null,"No",null,"Phase 2",1,110,"Anticipated","2018-01-29","2020-08-13","RR|PFS","Response Rate|Progression Free Survival",{"$nulls":3},"The purpose of this study is to evaluate efficacy and safety of Brigatinib in Japanese patients with anaplastic lymphoma kinase (ALK)-positive NSCLC.","The drug being tested in this study is called brigatinib. Brigatinib is being tested in patients with ALK-positive NSCLC in order to evaluate efficacy and safety of oral doses of brigatinib in Japanese patients with ALK-positive NSCLC.\n\nThe study will enroll approximately 110 participants. Participants will be enrolled in non-randomized and opened manner:\n\n- Brigatinib 90 mg for the first 7 days, followed by Brigatinib 180 mg of Brigatinib tablets, once daily in a 28-days cycle.\n\nAll participants will be asked to take tablets of brigatinib once daily with or without food throughout the study.\n\nThis multi-center trial will be conducted in Japan. The overall time to participate in this study is approximately 53 months. Participants will make multiple visits to the clinic during the treatment period, and posttreatment period including a follow-up assessment after last dose of study drug.","A Single-Arm, Multicenter, Phase 2 Study of Brigatinib in Japanese Patients With ALK-Positive Non-Small Cell Lung Cancer (NSCLC)","Brigatinib-2001","ALK-positive Advanced NSCLC","Non-Small-Cell Lung Cancer","Oncology Solid Tumor","Oncology","Experimental","Brigatinib 90 mg + Brigatinib 180 mg","90 mg of Brigatinib tablets, once daily for 7 days, followed by 180 mg of Brigatinib tablets, once daily in a 28-days cycle.","Drug","Brigatinib","Brigatinib tablet",null,"Brigatinib 90 mg + Brigatinib 180 mg","\n\n 1.  Male or female Japanese patients aged >=20 years on the day of consent.\n 2.  Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.\n 3.  Have histologically or cytologically confirmed stage IIIB, stage IIIC (locally advanced or recurrent and not a candidate for definitive multimodality therapy), or stage IV NSCLC.\n 4.  Have documentation of ALK rearrangement that meets following criteria.For the safety evaluation lead-in part and the refractory expansion part, patients must meet 1 of the following 2 criteria:\n     \n      1. Have documentation of ALK rearrangement by a positive result from the Vysis ALK Break Apart FISH [fluorescence in situ hybridization] Probe Kit, the Nichirei Histofine ALK iAEP Kit, or the Ventana ALK (D5F3) CDx Assay at any time during prior disease course. The sponsor may require an adequate tissue available for central laboratory testing by the Vysis ALK Break Apart FISH test if a documented ALK rearrangement is confirmed by a positive result from the Nichirei Histofine ALK iAEP Kit \"ONLY\".\n      2. Had a documented ALK rearrangement by a different test at any time during prior disease course, and adequate tissue available for central laboratory testing by the Vysis ALK Break Apart FISH test. Central confirmation of ALK rearrangement is not required before enrollment.\n     \n     For TKI-naÃ¯ve expansion cohort, patients must meet the following criteria Have documentation of ALK rearrangement by a positive result from MHLW Approved tests (e.g Vysis ALK Break Apart FISH Probe Kit, the Nichirei Histofine ALK iAEP Kit, or the Ventana ALK [D5F3] CDx Assay) prior to enrollment, and required to submit sufficient tumor tissue for central laboratory testing upon request of sponsor. Central confirmation of ALK rearrangement is not required before enrollment\n     \n     \n 5.  The refractory expansion part only: had documented progressive disease (PD) during treatment or within 30 days after discontinuation of treatment with ALK inhibitor. * Note 1: The refractory expansion part consists of the main cohort and a subcohort based on prior ALK inhibitor treatment. The main cohort includes patients who had previously received alectinib (as their only ALK inhibitor) or both crizotinib and alectinib (regardless the sequence of those 2 ALK inhibitors), and a total of 47 patients will be enrolled. Patients with all other sequences of up to 2 prior ALK inhibitor(s) may be included in the subcohort, and the number of patients will be limited to 20.\n      * Note 2: Patients who will be included in the main cohort of the refractory should have documented PD during treatment or within 30 days after discontinuation of treatment with alectinib.\n     \n     \n 6.  Have at least 1 measurable (ie, target) lesion per RECIST version 1.1. Note: Previously irradiated lesions may not be used for target lesions, unless there is unambiguous radiological progression after radiotherapy. Brain lesions may not be used as target lesions if they were 1) previously treated with whole brain radiation therapy (WBRT) within 3 months, or 2) previously treated by stereotactic radiosurgery (SRS) or surgical resection.\n 7.  Recovered from toxicities related to prior anticancer therapy to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03 Grade =<1. Note: Treatment-related alopecia is allowed.\n 8.  Have a life expectancy of >=3 months.\n 9.  Have adequate organ and hematologic function, as determined by: 1. Both alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =<2.5 times the upper limit of the normal range (ULN) (=<5Ã—ULN is acceptable if liver metastases are present).\n      2. Total serum bilirubin =<1.5Ã—ULN (<3.0Ã—ULN for patients with Gilbert syndrome).\n      3. Serum creatinine <1.5Ã—ULN. For patients with creatinine levels above or equal to 1.5Ã—ULN, the patient is eligible if the estimated creatinine clearance using the Cockcroft-Gault formula is >=30 mL/minute.\n      4. Serum lipase =<1.5Ã—ULN and serum amylase =<1.5Ã—ULN.\n      5. Absolute neutrophil count (ANC) >=1.5Ã—10^9/L.\n      6. Platelet count >=75Ã—10^9/L.\n      7. Hemoglobin >=9 g/dL.\n      8. Percutaneous oxygen saturation (SpO2) >=94% without oxygen support. Patients who need oxygen support are excluded.\n     \n     \n 10. Have an Eastern Cooperative Oncology Group (ECOG) performance status of =<2.\n 11. Must meet the following criteria: 1. Female patients who: * Are postmenopausal for at least 1 year before the screening visit, OR\n          * Are surgically sterile, OR\n          * If they are of childbearing potential, agree to practice 1 highly effective non-hormonal method of contraception and 1 additional effective (barrier) method at the same time, from the time of signing the informed consent through 4 months after the last dose of study drug, OR\n          * Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient, from the time of signing the informed consent through 4 months after that last dose of study drug. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together.)\n         \n         \n      2. Male patients, even if surgically sterilized (ie, status postvasectomy), who: * Agree to practice effective barrier contraception during the entire study treatment period and through 4 months after the last dose of study drug, OR\n          * Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient, during the entire study treatment period and through 4 months after that last dose of study drug. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together.)\n         \n         \n     \n     \n 12. Have the willingness and ability to comply with scheduled visit and study procedures.\n\n","\n\n 1.  Previously received the following treatments. The refractory expansion part only: received any prior ALK inhibitor not specified in the protocol.TKI-naÃ¯ve expansion cohort only: received any prior TKI including but not limited to ALK inhibitor and VEGFR TKI.\n     \n     \n 2.  The refractory expansion part only: received more than 2 prior ALK inhibitors. Note: The safety evaluation lead-in part allows patients with any line of prior ALK inhibitor which includes treatment-naÃ¯ve patients; however, ALK inhibitor-naÃ¯ve patients may be enrolled after the confirmation of first 3 DLT evaluable patients to have no more than 1 DLT during Cycle 1 by investigator's judgement.\n 3.  The safety evaluation lead-in part and the refractory expansion part only: received ALK inhibitor within 7 days before the first dose of brigatinib.\n 4.  Previously received more than 1 regimen (more than 3 regimens in the safety evaluation lead-in part) of systemic anticancer therapy (other than ALK inhibitors) for locally advanced or metastatic disease. Note: A systemic anticancer therapy regimen will be counted if it is administered over at least 1 cycle. A new anticancer agent used as maintenance therapy will be counted as a new regimen unless it was previously used as initial anticancer therapy. Neoadjuvant or adjuvant systemic anticancer therapy will be counted as a prior regimen if completion of (neo) adjuvant therapy occurred <12 months before the first dose of brigatinib.\n 5.  Treatment with any investigational products within 30 days or 5 half-lives of that investigational agent, whichever is longer, before the first dose of brigatinib.\n 6.  Received chemotherapy or radiation within 14 days before the first dose of brigatinib, except SRS or stereotactic body radiation therapy.\n 7.  Received antineoplastic monoclonal antibodies within 30 days before the first dose of brigatinib.\n 8.  Received systemic treatment with strong inhibitors or strong and moderate inducers of cytochrome P450 (CYP) 3A within 7 days before the first dose of brigatinib.\n 9.  Had major surgery within 30 days before the first dose of brigatinib. Minor surgical procedures such as venous catheter placement or minimally invasive biopsies are allowed.\n 10. Have been diagnosed with another primary malignancy other than NSCLC, except for the following adequately/definitively treated malignancies: nonmelanoma skin cancer, cervical cancer in situ, nonmetastatic prostate cancer; or patients with another primary malignancy who are definitively relapse-free with at least 3 years elapsed since the diagnosis of the other primary malignancy.\n 11. Have symptomatic central nervous system (CNS) metastases (parenchymal or leptomeningeal) at screening or asymptomatic disease requiring an increasing dose of corticosteroids to control symptoms within 7 days before the first dose of brigatinib. Note: If a patient has worsening neurological symptoms or signs due to CNS metastasis, the patient needs to complete local therapy and be neurologically stable (with no requirement for an increasing dose of corticosteroids or use of anticonvulsants for symptomatic control) for 7 days before the first dose of brigatinib.\n 12. Have current spinal cord compression (symptomatic or asymptomatic and detected by radiographic imaging). Patients with asymptomatic leptomeningeal disease and without cord compression are allowed.\n 13. Have ongoing or history of interstitial lung disease (ILD) (including interstitial pneumonitis, pneumonitis, radiation pneumonitis, drug-related pneumonitis, organized pneumonia, and pulmonary alveolitis).\n 14. Have significant, uncontrolled, or active cardiovascular disease, specifically including, but not limited to: 1. Myocardial infarction within 6 months before the first dose of brigatinib.\n      2. Unstable angina within 6 months before the first dose of brigatinib.\n      3. Congestive heart failure within 6 months before the first dose of brigatinib.\n      4. Uncontrolled atrial arrhythmias despite appropriate medical therapy.\n      5. History of ventricular arrhythmia, including history of ventricular tachycardia, ventricular fibrillation, or torsades de pointes. Patients with premature ventricular contractions are allowed.\n      6. Cerebrovascular accident or transient ischemic attack within 6 months before the first dose of brigatinib.\n     \n     \n 15. Have uncontrolled hypertension. Patients with hypertension should be under treatment at the start of screening and demonstrate adequate control of blood pressure.\n 16. Have an ongoing or active infection, including, but not limited to, the requirement for intravenous antibiotics.\n 17. Have a known history of HIV infection. Testing is not required in the absence of history.\n 18. Hepatitis B surface antigen (HBsAg) positive, detectable hepatitis B viral load, or detectable hepatitis C virus (HCV) infection viral load. Note: Patients who have positive hepatitis B core antibody (HBcAb) or hepatitis B surface antibody (HBsAb) can be enrolled but must have an undetectable hepatitis B viral load. Patients who have positive HCV antibody can be enrolled but must have an undetectable hepatitis C viral load.\n 19. Have malabsorption syndrome or other gastrointestinal illness that could affect oral absorption of brigatinib.\n 20. Have a known or suspected hypersensitivity to brigatinib or its excipients.\n 21. Female patients who are lactating and breastfeeding or have a positive serum pregnancy test during the screening period. Note: Female patients who are lactating will be excluded, even if they discontinue breastfeeding.\n 22. Have any condition or illness that, in the opinion of the investigator, would compromise patient safety or interfere with the evaluation of brigatinib.",{"$nulls":4},"Actual","2018-01-25","Actual","Anticipated","2022-05-31","Anticipated","2019-05-01","2018-01-11","2018-01-23","2019-05-30","No",null,"Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","20 Years",null,"All",null,"No","Yes",{"$nulls":3},"Yes","No",{"$nulls":4},"Yes",{"$nulls":12},"U1111-1204-8752|JapicCTI-183823","WHO|Registry Identifier: JapicCTI","Confirmed Objective Response Rate (ORR) in the Main Cohort of the Refractory Expansion Part|12 Months Progression-Free Survival (PFS) Rate in the Tyrosine Kinase Inhibitor (TKI) NaÃ¯ve Expansion Cohort","ORR is defined the percentage of the participants who are confirmed to have achieved complete response (CR) or partial response (PR) per an Independent Review Committee (IRC) using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 after the initiation of study treatment.|12 months PFS rate is defined as the percentage of the participants who do not have PFS events (Progression disease","Up to 23 months|PD per IRC using RECIST version 1.1, or death by any cause) at 12 months after the start of study treatment.","Confirmed ORR in the TKI-naÃ¯ve Expansion Cohort, the Overall Population of the Refractory Expansion Part, and the Safety Evaluation Lead-in Part|Duration of Response (DOR) in the TKI-naÃ¯ve Expansion Cohort, the Main Cohort of the Refractory Expansion Part, and the Overall Population of the Refractory Expansion Part|Progression-Free Survival (PFS) in the TKI-naÃ¯ve Expansion Cohort, the Main Cohort of the Refractory Expansion Part, and the Overall Population of the Refractory Expansion Part|Disease Control Rate (DCR) in the TKI-naÃ¯ve Expansion Cohort, the Main Cohort of the Refractory Expansion Part, and the Overall Population of the Refractory Expansion Part|Time to Response in the TKI-naÃ¯ve Expansion Cohort, the Main Cohort of the Refractory Expansion Part, and the Overall Population of the Refractory Expansion Part|Overall Survival (OS) in the TKI-naÃ¯ve Expansion Cohort, the Main Cohort of the Refractory Expansion Part, and the Overall Population of the Refractory Expansion Part|Central Nervous System (CNS) Response in the TKI-naÃ¯ve Expansion Cohort, the Main Cohort of the Refractory Expansion Part, and the Overall Population of the Refractory Expansion Part|Time on Treatment in the TKI-naÃ¯ve Expansion Cohort, the Main Cohort of the Refractory Expansion Part, and the Overall Population of the Refractory Expansion Part|Confirmed ORR in the TKI-naÃ¯ve Expansion Cohort, the Main Cohort of the Refractory Expansion Part, and the Safety Evaluation Lead-in Part|Patient-Reported Outcomes (PROs) of Health-Related Quality of Life (HRQOL) Scores and Symptoms of Lung Cancer in the TKI-naÃ¯ve Expansion Cohort, the Main Cohort of the Refractory Expansion Part, and the Safety Evaluation Lead-in Part|Cmax: Maximum Observed Plasma Concentration for Brigatinib on Cycle 1 Days 1 and 22|tmax: Time of First Occurrence of Cmax for Brigatinib on Cycle 1 Days 1 and 22|AUC: Area under the Plasma Concentration-Time Curve for Brigatinib on Cycle 1 Days 1 and 22","Up to 53 months|DOR will be assessed by an IRC, per RECIST version 1.1. DOR is defined as the time between the first documentation of objective tumor response (CR or PR) and the first subsequent documentation of objective progressive disease (PD) or death due to any cause, whichever occurs first.|PFS will be assessed by an IRC, per RECIST version 1.1. PFS is defined as the time from the start of study treatment to the first documentation of objective PD or to death due to any cause, whichever occurs first.|DCR will be assessed by an IRC, per RECIST version 1.1. DCR is defined as the percentage of participants who are confirmed to have achieved CR or PR or have a best overall response of stable disease (SD), per RECIST version 1.1, for 6 weeks or more after initiation of study drug.|Time to response will be assessed by an IRC, per RECIST version 1.1. Time to response is defined as the time interval from the date of the first dose of study treatment until the initial observation of CR or PR for patients with confirmed CR/PR.|OS is the time from the start of study treatment to the date of death.|CNS response will be assessed by an IRC, per modified RECIST version 1.1 for assessment of intracranial efficacy (intracranial objective response rate|Time on treatment is the time interval from the first dose to the last dose of Brigatinib.|The percentage of participants who are confirmed to have achieved CR or PR per investigator using RECIST version 1.1 after the initiation of study treatment.|PROs of HRQOL scores and symptoms of lung cancer, assessed with European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30, its lung cancer module QLQ-LC13, and the 5-level version of EuroQol 5-dimensional questionnaire (EQ-5D-5L) which are related to patient health, symptoms, and problems. Participants will answer for these questionalries. EORTC-QLQ-C30 contains 28 questions (4-point scale where 1=Not at all|Pre-dose and at multiple time points (0.5, 1, 2, 4, 6, 8, 12, 24; up to 24 hrs) post-dose of Cycle 1 Days 1 and 22","Up to 53 months|iORR and duration of intracranial response|best to 4=Very Much","medicalinformation@tpna.com","Takeda Study Registration Call Center",-5028,"Nagoya, Aichi, Japan Nagoya University HospitalNagoya, Aichi, Japan Fujita Health University HospitalToyoake, Aichi, Japan|Kashiwa, Chiba, Japan|Chiba, Japan Kyushu University HospitalFukuoka, Japan National Hospital Organization Kyushu Cancer CenterFukuoka, Japan Kyoto University HospitalKyoto, Japan Niigata Cancer Center HospitalNiigata, Japan Okayama University HospitalOkayama, Japan Osaka City General HospitalOsaka, Japan Osaka International Cancer InstituteOsaka, Japan Wakayama Medical University Hospital[Active, Not Recruiting]Wakayama, Japan|Matsuyama, Ehime, Japan|Kurume, Fukuoka, Japan|Sapporo, Hokkaido, Japan|Akashi, Hyogo, Japan Kobe City Medical Center General HospitalKobe, Hyogo, Japan|Kanazawa, Ishikawa, Japan|[Active, Not Recruiting]Morioka, Iwate, Japan|Yokohama, Kanagawa, Japan|Matsuzaka, Mie, Japan|[Active, Not Recruiting]Sendai, Miyagi, Japan|Kurashiki, Okayama, Japan|Hirakata, Osaka, Japan Kindai University Hospital[Active, Not Recruiting]Osakasayama, Osaka, Japan|Ina, Saitama, Japan|Nagaizumi-Cho, Shizuoka, Japan|Shimotsuke, Tochigi, Japan|Bunkyo-Ku, Tokyo, Japan Tokyo Metropolitan Cancer And Infectious Diseases Center Komagome HospitalBunkyo-Ku, Tokyo, Japan National Cancer Center Hospital[Active, Not Recruiting]Chuo-Ku, Tokyo, Japan Cancer Institute Hospital[Active, Not Recruiting]Koto-Ku, Tokyo, Japan",null,"Japan","Aichi Aichi Cancer Center Hospital|Chiba National Cancer Center Hospital East|Chiba University Hospital|Ehime National Hospital Organization Shikoku Cancer Center|Fukuoka Kurume University Hospital|Hokkaido Hokkaido Cancer Center|Hyogo Hyogo Cancer Center|Ishikawa Kanazawa University Hospital|Iwate Iwate Medical University Hospital|Kanagawa Kanagawa Cancer Center|Mie Matsuzaka Citizen's Hospital|Miyagi Sendai Kousei Hospital|Okayama Kurashiki Central Hospital|Osaka Kansai Medical University Hospital|Saitama Saitama Cancer Center|Shizuoka Shizuoka Cancer Center|Tochigi Jichi Medical University Hospital|Tokyo Juntendo University Hospital",{"$nulls":3},"Study Director","2019-05-30","2020-05-25T16:38:38.920","2020-05-26T17:10:42.972","NCT03410108"]
["5ecbf48f11702c1b1b916b53","NCT03410108","2019-11-07","Takeda","TAK","Recruiting","Phase 2 Study of Brigatinib in Japanese Patients With ALK-Positive Non-Small Cell Lung Cancer (NSCLC)","Brigatinib","TK Inhibitor|ALK Inhibitor","No",null,"No",null,"Phase 2",1,110,"Anticipated","2018-01-29","2020-08-13","RR|PFS","Response Rate|Progression Free Survival",{"$nulls":3},"The purpose of this study is to evaluate efficacy and safety of Brigatinib in Japanese patients with anaplastic lymphoma kinase (ALK)-positive NSCLC.","The drug being tested in this study is called brigatinib. Brigatinib is being tested in patients with ALK-positive NSCLC in order to evaluate efficacy and safety of oral doses of brigatinib in Japanese patients with ALK-positive NSCLC.\n\nThe study will enroll approximately 110 participants. Participants will be enrolled in non-randomized and opened manner:\n\n- Brigatinib 90 mg for the first 7 days, followed by Brigatinib 180 mg of Brigatinib tablets, once daily in a 28-days cycle.\n\nAll participants will be asked to take tablets of brigatinib once daily with or without food throughout the study.\n\nThis multi-center trial will be conducted in Japan. The overall time to participate in this study is approximately 53 months. Participants will make multiple visits to the clinic during the treatment period, and posttreatment period including a follow-up assessment after last dose of study drug.","A Single-Arm, Multicenter, Phase 2 Study of Brigatinib in Japanese Patients With ALK-Positive Non-Small Cell Lung Cancer (NSCLC)","Brigatinib-2001","ALK-positive Advanced NSCLC","Non-Small-Cell Lung Cancer","Oncology Solid Tumor","Oncology","Experimental","Brigatinib 90 mg + Brigatinib 180 mg","90 mg of Brigatinib tablets, once daily for 7 days, followed by 180 mg of Brigatinib tablets, once daily in a 28-days cycle.","Drug","Brigatinib","Brigatinib tablet",null,"Brigatinib 90 mg + Brigatinib 180 mg","\n\n 1.  Male or female Japanese patients aged >=20 years on the day of consent.\n 2.  Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.\n 3.  Have histologically or cytologically confirmed stage IIIB, stage IIIC (locally advanced or recurrent and not a candidate for definitive multimodality therapy), or stage IV NSCLC.\n 4.  Have documentation of ALK rearrangement that meets following criteria.For the safety evaluation lead-in part and the refractory expansion part, patients must meet 1 of the following 2 criteria:\n     \n      1. Have documentation of ALK rearrangement by a positive result from the Vysis ALK Break Apart FISH [fluorescence in situ hybridization] Probe Kit, the Nichirei Histofine ALK iAEP Kit, or the Ventana ALK (D5F3) CDx Assay at any time during prior disease course. The sponsor may require an adequate tissue available for central laboratory testing by the Vysis ALK Break Apart FISH test if a documented ALK rearrangement is confirmed by a positive result from the Nichirei Histofine ALK iAEP Kit \"ONLY\".\n      2. Had a documented ALK rearrangement by a different test at any time during prior disease course, and adequate tissue available for central laboratory testing by the Vysis ALK Break Apart FISH test. Central confirmation of ALK rearrangement is not required before enrollment.\n     \n     For TKI-naÃ¯ve expansion cohort, patients must meet the following criteria Have documentation of ALK rearrangement by a positive result from MHLW Approved tests (e.g Vysis ALK Break Apart FISH Probe Kit, the Nichirei Histofine ALK iAEP Kit, or the Ventana ALK [D5F3] CDx Assay) prior to enrollment, and required to submit sufficient tumor tissue for central laboratory testing upon request of sponsor. Central confirmation of ALK rearrangement is not required before enrollment\n     \n     \n 5.  The refractory expansion part only: had documented progressive disease (PD) during treatment or within 30 days after discontinuation of treatment with ALK inhibitor. * Note 1: The refractory expansion part consists of the main cohort and a subcohort based on prior ALK inhibitor treatment. The main cohort includes patients who had previously received alectinib (as their only ALK inhibitor) or both crizotinib and alectinib (regardless the sequence of those 2 ALK inhibitors), and a total of 47 patients will be enrolled. Patients with all other sequences of up to 2 prior ALK inhibitor(s) may be included in the subcohort, and the number of patients will be limited to 20.\n      * Note 2: Patients who will be included in the main cohort of the refractory should have documented PD during treatment or within 30 days after discontinuation of treatment with alectinib.\n     \n     \n 6.  Have at least 1 measurable (ie, target) lesion per RECIST version 1.1. Note: Previously irradiated lesions may not be used for target lesions, unless there is unambiguous radiological progression after radiotherapy. Brain lesions may not be used as target lesions if they were 1) previously treated with whole brain radiation therapy (WBRT) within 3 months, or 2) previously treated by stereotactic radiosurgery (SRS) or surgical resection.\n 7.  Recovered from toxicities related to prior anticancer therapy to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03 Grade =<1. Note: Treatment-related alopecia is allowed.\n 8.  Have a life expectancy of >=3 months.\n 9.  Have adequate organ and hematologic function, as determined by: 1. Both alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =<2.5 times the upper limit of the normal range (ULN) (=<5Ã—ULN is acceptable if liver metastases are present).\n      2. Total serum bilirubin =<1.5Ã—ULN (<3.0Ã—ULN for patients with Gilbert syndrome).\n      3. Serum creatinine <1.5Ã—ULN. For patients with creatinine levels above or equal to 1.5Ã—ULN, the patient is eligible if the estimated creatinine clearance using the Cockcroft-Gault formula is >=30 mL/minute.\n      4. Serum lipase =<1.5Ã—ULN and serum amylase =<1.5Ã—ULN.\n      5. Absolute neutrophil count (ANC) >=1.5Ã—10^9/L.\n      6. Platelet count >=75Ã—10^9/L.\n      7. Hemoglobin >=9 g/dL.\n      8. Percutaneous oxygen saturation (SpO2) >=94% without oxygen support. Patients who need oxygen support are excluded.\n     \n     \n 10. Have an Eastern Cooperative Oncology Group (ECOG) performance status of =<2.\n 11. Must meet the following criteria: 1. Female patients who: * Are postmenopausal for at least 1 year before the screening visit, OR\n          * Are surgically sterile, OR\n          * If they are of childbearing potential, agree to practice 1 highly effective non-hormonal method of contraception and 1 additional effective (barrier) method at the same time, from the time of signing the informed consent through 4 months after the last dose of study drug, OR\n          * Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient, from the time of signing the informed consent through 4 months after that last dose of study drug. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together.)\n         \n         \n      2. Male patients, even if surgically sterilized (ie, status postvasectomy), who: * Agree to practice effective barrier contraception during the entire study treatment period and through 4 months after the last dose of study drug, OR\n          * Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient, during the entire study treatment period and through 4 months after that last dose of study drug. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together.)\n         \n         \n     \n     \n 12. Have the willingness and ability to comply with scheduled visit and study procedures.\n\n","\n\n 1.  Previously received the following treatments. The refractory expansion part only: received any prior ALK inhibitor not specified in the protocol.TKI-naÃ¯ve expansion cohort only: received any prior TKI including but not limited to ALK inhibitor and VEGFR TKI.\n     \n     \n 2.  The refractory expansion part only: received more than 2 prior ALK inhibitors. Note: The safety evaluation lead-in part allows patients with any line of prior ALK inhibitor which includes treatment-naÃ¯ve patients; however, ALK inhibitor-naÃ¯ve patients may be enrolled after the confirmation of first 3 DLT evaluable patients to have no more than 1 DLT during Cycle 1 by investigator's judgement.\n 3.  The safety evaluation lead-in part and the refractory expansion part only: received ALK inhibitor within 7 days before the first dose of brigatinib.\n 4.  Previously received more than 1 regimen (more than 3 regimens in the safety evaluation lead-in part) of systemic anticancer therapy (other than ALK inhibitors) for locally advanced or metastatic disease. Note: A systemic anticancer therapy regimen will be counted if it is administered over at least 1 cycle. A new anticancer agent used as maintenance therapy will be counted as a new regimen unless it was previously used as initial anticancer therapy. Neoadjuvant or adjuvant systemic anticancer therapy will be counted as a prior regimen if completion of (neo) adjuvant therapy occurred <12 months before the first dose of brigatinib.\n 5.  Treatment with any investigational products within 30 days or 5 half-lives of that investigational agent, whichever is longer, before the first dose of brigatinib.\n 6.  Received chemotherapy or radiation within 14 days before the first dose of brigatinib, except SRS or stereotactic body radiation therapy.\n 7.  Received antineoplastic monoclonal antibodies within 30 days before the first dose of brigatinib.\n 8.  Received systemic treatment with strong inhibitors or strong and moderate inducers of cytochrome P450 (CYP) 3A within 7 days before the first dose of brigatinib.\n 9.  Had major surgery within 30 days before the first dose of brigatinib. Minor surgical procedures such as venous catheter placement or minimally invasive biopsies are allowed.\n 10. Have been diagnosed with another primary malignancy other than NSCLC, except for the following adequately/definitively treated malignancies: nonmelanoma skin cancer, cervical cancer in situ, nonmetastatic prostate cancer; or patients with another primary malignancy who are definitively relapse-free with at least 3 years elapsed since the diagnosis of the other primary malignancy.\n 11. Have symptomatic central nervous system (CNS) metastases (parenchymal or leptomeningeal) at screening or asymptomatic disease requiring an increasing dose of corticosteroids to control symptoms within 7 days before the first dose of brigatinib. Note: If a patient has worsening neurological symptoms or signs due to CNS metastasis, the patient needs to complete local therapy and be neurologically stable (with no requirement for an increasing dose of corticosteroids or use of anticonvulsants for symptomatic control) for 7 days before the first dose of brigatinib.\n 12. Have current spinal cord compression (symptomatic or asymptomatic and detected by radiographic imaging). Patients with asymptomatic leptomeningeal disease and without cord compression are allowed.\n 13. Have ongoing or history of interstitial lung disease (ILD) (including interstitial pneumonitis, pneumonitis, radiation pneumonitis, drug-related pneumonitis, organized pneumonia, and pulmonary alveolitis).\n 14. Have significant, uncontrolled, or active cardiovascular disease, specifically including, but not limited to: 1. Myocardial infarction within 6 months before the first dose of brigatinib.\n      2. Unstable angina within 6 months before the first dose of brigatinib.\n      3. Congestive heart failure within 6 months before the first dose of brigatinib.\n      4. Uncontrolled atrial arrhythmias despite appropriate medical therapy.\n      5. History of ventricular arrhythmia, including history of ventricular tachycardia, ventricular fibrillation, or torsades de pointes. Patients with premature ventricular contractions are allowed.\n      6. Cerebrovascular accident or transient ischemic attack within 6 months before the first dose of brigatinib.\n     \n     \n 15. Have uncontrolled hypertension. Patients with hypertension should be under treatment at the start of screening and demonstrate adequate control of blood pressure.\n 16. Have an ongoing or active infection, including, but not limited to, the requirement for intravenous antibiotics.\n 17. Have a known history of HIV infection. Testing is not required in the absence of history.\n 18. Hepatitis B surface antigen (HBsAg) positive, detectable hepatitis B viral load, or detectable hepatitis C virus (HCV) infection viral load. Note: Patients who have positive hepatitis B core antibody (HBcAb) or hepatitis B surface antibody (HBsAb) can be enrolled but must have an undetectable hepatitis B viral load. Patients who have positive HCV antibody can be enrolled but must have an undetectable hepatitis C viral load.\n 19. Have malabsorption syndrome or other gastrointestinal illness that could affect oral absorption of brigatinib.\n 20. Have a known or suspected hypersensitivity to brigatinib or its excipients.\n 21. Female patients who are lactating and breastfeeding or have a positive serum pregnancy test during the screening period. Note: Female patients who are lactating will be excluded, even if they discontinue breastfeeding.\n 22. Have any condition or illness that, in the opinion of the investigator, would compromise patient safety or interfere with the evaluation of brigatinib.",{"$nulls":4},"Actual","2018-01-25","Actual","Anticipated","2022-05-31","Anticipated","2019-11-01","2018-01-11","2018-01-23","2019-11-05","No",null,"Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","20 Years",null,"All",null,"No","Yes\nTakeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.",{"$nulls":3},"Yes","No",{"$nulls":4},"Yes",{"$nulls":12},"U1111-1204-8752|JapicCTI-183823","WHO|Registry Identifier: JapicCTI","Confirmed Objective Response Rate (ORR) in the Main Cohort of the Refractory Expansion Part|12 Months Progression-Free Survival (PFS) Rate in the Tyrosine Kinase Inhibitor (TKI) NaÃ¯ve Expansion Cohort","ORR is defined the percentage of the participants who are confirmed to have achieved complete response (CR) or partial response (PR) per an Independent Review Committee (IRC) using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 after the initiation of study treatment.|12 months PFS rate is defined as the percentage of the participants who do not have PFS events (Progression disease","Up to 23 months|PD per IRC using RECIST version 1.1, or death by any cause) at 12 months after the start of study treatment.","Confirmed ORR in the TKI-naÃ¯ve Expansion Cohort, the Overall Population of the Refractory Expansion Part, and the Safety Evaluation Lead-in Part|Duration of Response (DOR) in the TKI-naÃ¯ve Expansion Cohort, the Main Cohort of the Refractory Expansion Part, and the Overall Population of the Refractory Expansion Part|Progression-Free Survival (PFS) in the TKI-naÃ¯ve Expansion Cohort, the Main Cohort of the Refractory Expansion Part, and the Overall Population of the Refractory Expansion Part|Disease Control Rate (DCR) in the TKI-naÃ¯ve Expansion Cohort, the Main Cohort of the Refractory Expansion Part, and the Overall Population of the Refractory Expansion Part|Time to Response in the TKI-naÃ¯ve Expansion Cohort, the Main Cohort of the Refractory Expansion Part, and the Overall Population of the Refractory Expansion Part|Overall Survival (OS) in the TKI-naÃ¯ve Expansion Cohort, the Main Cohort of the Refractory Expansion Part, and the Overall Population of the Refractory Expansion Part|Central Nervous System (CNS) Response in the TKI-naÃ¯ve Expansion Cohort, the Main Cohort of the Refractory Expansion Part, and the Overall Population of the Refractory Expansion Part|Time on Treatment in the TKI-naÃ¯ve Expansion Cohort, the Main Cohort of the Refractory Expansion Part, and the Overall Population of the Refractory Expansion Part|Confirmed ORR in the TKI-naÃ¯ve Expansion Cohort, the Main Cohort of the Refractory Expansion Part, and the Safety Evaluation Lead-in Part|Patient-Reported Outcomes (PROs) of Health-Related Quality of Life (HRQOL) Scores and Symptoms of Lung Cancer in the TKI-naÃ¯ve Expansion Cohort, the Main Cohort of the Refractory Expansion Part, and the Safety Evaluation Lead-in Part|Cmax: Maximum Observed Plasma Concentration for Brigatinib on Cycle 1 Days 1 and 22|tmax: Time of First Occurrence of Cmax for Brigatinib on Cycle 1 Days 1 and 22|AUC: Area under the Plasma Concentration-Time Curve for Brigatinib on Cycle 1 Days 1 and 22","Up to 53 months|DOR will be assessed by an IRC, per RECIST version 1.1. DOR is defined as the time between the first documentation of objective tumor response (CR or PR) and the first subsequent documentation of objective progressive disease (PD) or death due to any cause, whichever occurs first.|PFS will be assessed by an IRC, per RECIST version 1.1. PFS is defined as the time from the start of study treatment to the first documentation of objective PD or to death due to any cause, whichever occurs first.|DCR will be assessed by an IRC, per RECIST version 1.1. DCR is defined as the percentage of participants who are confirmed to have achieved CR or PR or have a best overall response of stable disease (SD), per RECIST version 1.1, for 6 weeks or more after initiation of study drug.|Time to response will be assessed by an IRC, per RECIST version 1.1. Time to response is defined as the time interval from the date of the first dose of study treatment until the initial observation of CR or PR for patients with confirmed CR/PR.|OS is the time from the start of study treatment to the date of death.|CNS response will be assessed by an IRC, per modified RECIST version 1.1 for assessment of intracranial efficacy (intracranial objective response rate|Time on treatment is the time interval from the first dose to the last dose of Brigatinib.|The percentage of participants who are confirmed to have achieved CR or PR per investigator using RECIST version 1.1 after the initiation of study treatment.|PROs of HRQOL scores and symptoms of lung cancer, assessed with European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30, its lung cancer module QLQ-LC13, and the 5-level version of EuroQol 5-dimensional questionnaire (EQ-5D-5L) which are related to patient health, symptoms, and problems. Participants will answer for these questionalries. EORTC-QLQ-C30 contains 28 questions (4-point scale where 1=Not at all|Pre-dose and at multiple time points (0.5, 1, 2, 4, 6, 8, 12, 24; up to 24 hrs) post-dose of Cycle 1 Days 1 and 22","Up to 53 months|iORR and duration of intracranial response|best to 4=Very Much","medicalinformation@tpna.com","Takeda Study Registration Call Center",-5028,"Nagoya, Aichi, Japan Nagoya University HospitalNagoya, Aichi, Japan Fujita Health University HospitalToyoake, Aichi, Japan|Kashiwa, Chiba, Japan|Chiba, Japan Kyushu University HospitalFukuoka, Japan National Hospital Organization Kyushu Cancer CenterFukuoka, Japan Kyoto University HospitalKyoto, Japan Niigata Cancer Center HospitalNiigata, Japan Okayama University HospitalOkayama, Japan Osaka City General HospitalOsaka, Japan Osaka International Cancer InstituteOsaka, Japan Wakayama Medical University Hospital[Active, Not Recruiting]Wakayama, Japan|Matsuyama, Ehime, Japan|Kurume, Fukuoka, Japan|Sapporo, Hokkaido, Japan|Akashi, Hyogo, Japan Kobe City Medical Center General HospitalKobe, Hyogo, Japan|Kanazawa, Ishikawa, Japan|Morioka, Iwate, Japan|Yokohama, Kanagawa, Japan|Matsuzaka, Mie, Japan|[Active, Not Recruiting]Sendai, Miyagi, Japan|Kurashiki, Okayama, Japan|[Active, Not Recruiting]Hirakata, Osaka, Japan Kindai University Hospital[Active, Not Recruiting]Osakasayama, Osaka, Japan|Ina, Saitama, Japan|Nagaizumi-Cho, Shizuoka, Japan|Shimotsuke, Tochigi, Japan|Bunkyo-Ku, Tokyo, Japan Tokyo Metropolitan Cancer And Infectious Diseases Center Komagome HospitalBunkyo-Ku, Tokyo, Japan National Cancer Center Hospital[Active, Not Recruiting]Chuo-Ku, Tokyo, Japan Cancer Institute Hospital[Active, Not Recruiting]Koto-Ku, Tokyo, Japan",null,"Japan","Aichi Aichi Cancer Center Hospital|Chiba National Cancer Center Hospital East|Chiba University Hospital|Ehime National Hospital Organization Shikoku Cancer Center|Fukuoka Kurume University Hospital|Hokkaido Hokkaido Cancer Center|Hyogo Hyogo Cancer Center|Ishikawa Kanazawa University Hospital|Iwate Iwate Medical University Hospital|Kanagawa Kanagawa Cancer Center|Mie Matsuzaka Citizen's Hospital|Miyagi Sendai Kousei Hospital|Okayama Kurashiki Central Hospital|Osaka Kansai Medical University Hospital|Saitama Saitama Cancer Center|Shizuoka Shizuoka Cancer Center|Tochigi Jichi Medical University Hospital|Tokyo Juntendo University Hospital",{"$nulls":3},"Study Director","2019-11-05","2020-05-25T16:38:39.225","2020-05-26T17:10:42.972","NCT03410108"]
["5ecbf48fe2561b1b11905e40","NCT03410108","2019-12-02","Takeda","TAK","Active, not recruiting","Phase 2 Study of Brigatinib in Japanese Patients With ALK-Positive Non-Small Cell Lung Cancer (NSCLC)","Brigatinib","TK Inhibitor|ALK Inhibitor","No",null,"No",null,"Phase 2",1,104,"Actual","2018-01-29","2020-08-13","RR|PFS","Response Rate|Progression Free Survival",{"$nulls":3},"The purpose of this study is to evaluate efficacy and safety of Brigatinib in Japanese patients with anaplastic lymphoma kinase (ALK)-positive NSCLC.","The drug being tested in this study is called brigatinib. Brigatinib is being tested in patients with ALK-positive NSCLC in order to evaluate efficacy and safety of oral doses of brigatinib in Japanese patients with ALK-positive NSCLC.\n\nThe study will enroll approximately 110 participants. Participants will be enrolled in non-randomized and opened manner:\n\n- Brigatinib 90 mg for the first 7 days, followed by Brigatinib 180 mg of Brigatinib tablets, once daily in a 28-days cycle.\n\nAll participants will be asked to take tablets of brigatinib once daily with or without food throughout the study.\n\nThis multi-center trial will be conducted in Japan. The overall time to participate in this study is approximately 53 months. Participants will make multiple visits to the clinic during the treatment period, and posttreatment period including a follow-up assessment after last dose of study drug.","A Single-Arm, Multicenter, Phase 2 Study of Brigatinib in Japanese Patients With ALK-Positive Non-Small Cell Lung Cancer (NSCLC)","Brigatinib-2001","ALK-positive Advanced NSCLC","Non-Small-Cell Lung Cancer","Oncology Solid Tumor","Oncology","Experimental","Brigatinib 90 mg + Brigatinib 180 mg","90 mg of Brigatinib tablets, once daily for 7 days, followed by 180 mg of Brigatinib tablets, once daily in a 28-days cycle.","Drug","Brigatinib","Brigatinib tablet",null,"Brigatinib 90 mg + Brigatinib 180 mg","\n\n 1.  Male or female Japanese patients aged >=20 years on the day of consent.\n 2.  Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.\n 3.  Have histologically or cytologically confirmed stage IIIB, stage IIIC (locally advanced or recurrent and not a candidate for definitive multimodality therapy), or stage IV NSCLC.\n 4.  Have documentation of ALK rearrangement that meets following criteria.For the safety evaluation lead-in part and the refractory expansion part, patients must meet 1 of the following 2 criteria:\n     \n      1. Have documentation of ALK rearrangement by a positive result from the Vysis ALK Break Apart FISH [fluorescence in situ hybridization] Probe Kit, the Nichirei Histofine ALK iAEP Kit, or the Ventana ALK (D5F3) CDx Assay at any time during prior disease course. The sponsor may require an adequate tissue available for central laboratory testing by the Vysis ALK Break Apart FISH test if a documented ALK rearrangement is confirmed by a positive result from the Nichirei Histofine ALK iAEP Kit \"ONLY\".\n      2. Had a documented ALK rearrangement by a different test at any time during prior disease course, and adequate tissue available for central laboratory testing by the Vysis ALK Break Apart FISH test. Central confirmation of ALK rearrangement is not required before enrollment.\n     \n     For TKI-naÃ¯ve expansion cohort, patients must meet the following criteria Have documentation of ALK rearrangement by a positive result from MHLW Approved tests (e.g Vysis ALK Break Apart FISH Probe Kit, the Nichirei Histofine ALK iAEP Kit, or the Ventana ALK [D5F3] CDx Assay) prior to enrollment, and required to submit sufficient tumor tissue for central laboratory testing upon request of sponsor. Central confirmation of ALK rearrangement is not required before enrollment\n     \n     \n 5.  The refractory expansion part only: had documented progressive disease (PD) during treatment or within 30 days after discontinuation of treatment with ALK inhibitor. * Note 1: The refractory expansion part consists of the main cohort and a subcohort based on prior ALK inhibitor treatment. The main cohort includes patients who had previously received alectinib (as their only ALK inhibitor) or both crizotinib and alectinib (regardless the sequence of those 2 ALK inhibitors), and a total of 47 patients will be enrolled. Patients with all other sequences of up to 2 prior ALK inhibitor(s) may be included in the subcohort, and the number of patients will be limited to 20.\n      * Note 2: Patients who will be included in the main cohort of the refractory should have documented PD during treatment or within 30 days after discontinuation of treatment with alectinib.\n     \n     \n 6.  Have at least 1 measurable (ie, target) lesion per RECIST version 1.1. Note: Previously irradiated lesions may not be used for target lesions, unless there is unambiguous radiological progression after radiotherapy. Brain lesions may not be used as target lesions if they were 1) previously treated with whole brain radiation therapy (WBRT) within 3 months, or 2) previously treated by stereotactic radiosurgery (SRS) or surgical resection.\n 7.  Recovered from toxicities related to prior anticancer therapy to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03 Grade =<1. Note: Treatment-related alopecia is allowed.\n 8.  Have a life expectancy of >=3 months.\n 9.  Have adequate organ and hematologic function, as determined by: 1. Both alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =<2.5 times the upper limit of the normal range (ULN) (=<5Ã—ULN is acceptable if liver metastases are present).\n      2. Total serum bilirubin =<1.5Ã—ULN (<3.0Ã—ULN for patients with Gilbert syndrome).\n      3. Serum creatinine <1.5Ã—ULN. For patients with creatinine levels above or equal to 1.5Ã—ULN, the patient is eligible if the estimated creatinine clearance using the Cockcroft-Gault formula is >=30 mL/minute.\n      4. Serum lipase =<1.5Ã—ULN and serum amylase =<1.5Ã—ULN.\n      5. Absolute neutrophil count (ANC) >=1.5Ã—10^9/L.\n      6. Platelet count >=75Ã—10^9/L.\n      7. Hemoglobin >=9 g/dL.\n      8. Percutaneous oxygen saturation (SpO2) >=94% without oxygen support. Patients who need oxygen support are excluded.\n     \n     \n 10. Have an Eastern Cooperative Oncology Group (ECOG) performance status of =<2.\n 11. Must meet the following criteria: 1. Female patients who: * Are postmenopausal for at least 1 year before the screening visit, OR\n          * Are surgically sterile, OR\n          * If they are of childbearing potential, agree to practice 1 highly effective non-hormonal method of contraception and 1 additional effective (barrier) method at the same time, from the time of signing the informed consent through 4 months after the last dose of study drug, OR\n          * Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient, from the time of signing the informed consent through 4 months after that last dose of study drug. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together.)\n         \n         \n      2. Male patients, even if surgically sterilized (ie, status postvasectomy), who: * Agree to practice effective barrier contraception during the entire study treatment period and through 4 months after the last dose of study drug, OR\n          * Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient, during the entire study treatment period and through 4 months after that last dose of study drug. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together.)\n         \n         \n     \n     \n 12. Have the willingness and ability to comply with scheduled visit and study procedures.\n\n","\n\n 1.  Previously received the following treatments. The refractory expansion part only: received any prior ALK inhibitor not specified in the protocol.TKI-naÃ¯ve expansion cohort only: received any prior TKI including but not limited to ALK inhibitor and VEGFR TKI.\n     \n     \n 2.  The refractory expansion part only: received more than 2 prior ALK inhibitors. Note: The safety evaluation lead-in part allows patients with any line of prior ALK inhibitor which includes treatment-naÃ¯ve patients; however, ALK inhibitor-naÃ¯ve patients may be enrolled after the confirmation of first 3 DLT evaluable patients to have no more than 1 DLT during Cycle 1 by investigator's judgement.\n 3.  The safety evaluation lead-in part and the refractory expansion part only: received ALK inhibitor within 7 days before the first dose of brigatinib.\n 4.  Previously received more than 1 regimen (more than 3 regimens in the safety evaluation lead-in part) of systemic anticancer therapy (other than ALK inhibitors) for locally advanced or metastatic disease. Note: A systemic anticancer therapy regimen will be counted if it is administered over at least 1 cycle. A new anticancer agent used as maintenance therapy will be counted as a new regimen unless it was previously used as initial anticancer therapy. Neoadjuvant or adjuvant systemic anticancer therapy will be counted as a prior regimen if completion of (neo) adjuvant therapy occurred <12 months before the first dose of brigatinib.\n 5.  Treatment with any investigational products within 30 days or 5 half-lives of that investigational agent, whichever is longer, before the first dose of brigatinib.\n 6.  Received chemotherapy or radiation within 14 days before the first dose of brigatinib, except SRS or stereotactic body radiation therapy.\n 7.  Received antineoplastic monoclonal antibodies within 30 days before the first dose of brigatinib.\n 8.  Received systemic treatment with strong inhibitors or strong and moderate inducers of cytochrome P450 (CYP) 3A within 7 days before the first dose of brigatinib.\n 9.  Had major surgery within 30 days before the first dose of brigatinib. Minor surgical procedures such as venous catheter placement or minimally invasive biopsies are allowed.\n 10. Have been diagnosed with another primary malignancy other than NSCLC, except for the following adequately/definitively treated malignancies: nonmelanoma skin cancer, cervical cancer in situ, nonmetastatic prostate cancer; or patients with another primary malignancy who are definitively relapse-free with at least 3 years elapsed since the diagnosis of the other primary malignancy.\n 11. Have symptomatic central nervous system (CNS) metastases (parenchymal or leptomeningeal) at screening or asymptomatic disease requiring an increasing dose of corticosteroids to control symptoms within 7 days before the first dose of brigatinib. Note: If a patient has worsening neurological symptoms or signs due to CNS metastasis, the patient needs to complete local therapy and be neurologically stable (with no requirement for an increasing dose of corticosteroids or use of anticonvulsants for symptomatic control) for 7 days before the first dose of brigatinib.\n 12. Have current spinal cord compression (symptomatic or asymptomatic and detected by radiographic imaging). Patients with asymptomatic leptomeningeal disease and without cord compression are allowed.\n 13. Have ongoing or history of interstitial lung disease (ILD) (including interstitial pneumonitis, pneumonitis, radiation pneumonitis, drug-related pneumonitis, organized pneumonia, and pulmonary alveolitis).\n 14. Have significant, uncontrolled, or active cardiovascular disease, specifically including, but not limited to: 1. Myocardial infarction within 6 months before the first dose of brigatinib.\n      2. Unstable angina within 6 months before the first dose of brigatinib.\n      3. Congestive heart failure within 6 months before the first dose of brigatinib.\n      4. Uncontrolled atrial arrhythmias despite appropriate medical therapy.\n      5. History of ventricular arrhythmia, including history of ventricular tachycardia, ventricular fibrillation, or torsades de pointes. Patients with premature ventricular contractions are allowed.\n      6. Cerebrovascular accident or transient ischemic attack within 6 months before the first dose of brigatinib.\n     \n     \n 15. Have uncontrolled hypertension. Patients with hypertension should be under treatment at the start of screening and demonstrate adequate control of blood pressure.\n 16. Have an ongoing or active infection, including, but not limited to, the requirement for intravenous antibiotics.\n 17. Have a known history of HIV infection. Testing is not required in the absence of history.\n 18. Hepatitis B surface antigen (HBsAg) positive, detectable hepatitis B viral load, or detectable hepatitis C virus (HCV) infection viral load. Note: Patients who have positive hepatitis B core antibody (HBcAb) or hepatitis B surface antibody (HBsAb) can be enrolled but must have an undetectable hepatitis B viral load. Patients who have positive HCV antibody can be enrolled but must have an undetectable hepatitis C viral load.\n 19. Have malabsorption syndrome or other gastrointestinal illness that could affect oral absorption of brigatinib.\n 20. Have a known or suspected hypersensitivity to brigatinib or its excipients.\n 21. Female patients who are lactating and breastfeeding or have a positive serum pregnancy test during the screening period. Note: Female patients who are lactating will be excluded, even if they discontinue breastfeeding.\n 22. Have any condition or illness that, in the opinion of the investigator, would compromise patient safety or interfere with the evaluation of brigatinib.",{"$nulls":4},"Actual","2018-01-25","Actual","Anticipated","2022-05-31","Anticipated","2019-11-01","2018-01-11","2018-01-23","2019-11-29","No",null,"Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","20 Years",null,"All",null,"No","Yes\nTakeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.",{"$nulls":3},"Yes","No",{"$nulls":4},"Yes",{"$nulls":12},"U1111-1204-8752|JapicCTI-183823","WHO|Registry Identifier: JapicCTI","Confirmed Objective Response Rate (ORR) in the Main Cohort of the Refractory Expansion Part|12 Months Progression-Free Survival (PFS) Rate in the Tyrosine Kinase Inhibitor (TKI) NaÃ¯ve Expansion Cohort","ORR is defined the percentage of the participants who are confirmed to have achieved complete response (CR) or partial response (PR) per an Independent Review Committee (IRC) using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 after the initiation of study treatment.|12 months PFS rate is defined as the percentage of the participants who do not have PFS events (Progression disease","Up to 23 months|PD per IRC using RECIST version 1.1, or death by any cause) at 12 months after the start of study treatment.","Confirmed ORR in the TKI-naÃ¯ve Expansion Cohort, the Overall Population of the Refractory Expansion Part, and the Safety Evaluation Lead-in Part|Duration of Response (DOR) in the TKI-naÃ¯ve Expansion Cohort, the Main Cohort of the Refractory Expansion Part, and the Overall Population of the Refractory Expansion Part|Progression-Free Survival (PFS) in the TKI-naÃ¯ve Expansion Cohort, the Main Cohort of the Refractory Expansion Part, and the Overall Population of the Refractory Expansion Part|Disease Control Rate (DCR) in the TKI-naÃ¯ve Expansion Cohort, the Main Cohort of the Refractory Expansion Part, and the Overall Population of the Refractory Expansion Part|Time to Response in the TKI-naÃ¯ve Expansion Cohort, the Main Cohort of the Refractory Expansion Part, and the Overall Population of the Refractory Expansion Part|Overall Survival (OS) in the TKI-naÃ¯ve Expansion Cohort, the Main Cohort of the Refractory Expansion Part, and the Overall Population of the Refractory Expansion Part|Central Nervous System (CNS) Response in the TKI-naÃ¯ve Expansion Cohort, the Main Cohort of the Refractory Expansion Part, and the Overall Population of the Refractory Expansion Part|Time on Treatment in the TKI-naÃ¯ve Expansion Cohort, the Main Cohort of the Refractory Expansion Part, and the Overall Population of the Refractory Expansion Part|Confirmed ORR in the TKI-naÃ¯ve Expansion Cohort, the Main Cohort of the Refractory Expansion Part, and the Safety Evaluation Lead-in Part|Patient-Reported Outcomes (PROs) of Health-Related Quality of Life (HRQOL) Scores and Symptoms of Lung Cancer in the TKI-naÃ¯ve Expansion Cohort, the Main Cohort of the Refractory Expansion Part, and the Safety Evaluation Lead-in Part|Cmax: Maximum Observed Plasma Concentration for Brigatinib on Cycle 1 Days 1 and 22|tmax: Time of First Occurrence of Cmax for Brigatinib on Cycle 1 Days 1 and 22|AUC: Area under the Plasma Concentration-Time Curve for Brigatinib on Cycle 1 Days 1 and 22","Up to 53 months|DOR will be assessed by an IRC, per RECIST version 1.1. DOR is defined as the time between the first documentation of objective tumor response (CR or PR) and the first subsequent documentation of objective progressive disease (PD) or death due to any cause, whichever occurs first.|PFS will be assessed by an IRC, per RECIST version 1.1. PFS is defined as the time from the start of study treatment to the first documentation of objective PD or to death due to any cause, whichever occurs first.|DCR will be assessed by an IRC, per RECIST version 1.1. DCR is defined as the percentage of participants who are confirmed to have achieved CR or PR or have a best overall response of stable disease (SD), per RECIST version 1.1, for 6 weeks or more after initiation of study drug.|Time to response will be assessed by an IRC, per RECIST version 1.1. Time to response is defined as the time interval from the date of the first dose of study treatment until the initial observation of CR or PR for patients with confirmed CR/PR.|OS is the time from the start of study treatment to the date of death.|CNS response will be assessed by an IRC, per modified RECIST version 1.1 for assessment of intracranial efficacy (intracranial objective response rate|Time on treatment is the time interval from the first dose to the last dose of Brigatinib.|The percentage of participants who are confirmed to have achieved CR or PR per investigator using RECIST version 1.1 after the initiation of study treatment.|PROs of HRQOL scores and symptoms of lung cancer, assessed with European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30, its lung cancer module QLQ-LC13, and the 5-level version of EuroQol 5-dimensional questionnaire (EQ-5D-5L) which are related to patient health, symptoms, and problems. Participants will answer for these questionalries. EORTC-QLQ-C30 contains 28 questions (4-point scale where 1=Not at all|Pre-dose and at multiple time points (0.5, 1, 2, 4, 6, 8, 12, 24; up to 24 hrs) post-dose of Cycle 1 Days 1 and 22","Up to 53 months|iORR and duration of intracranial response|best to 4=Very Much",{"$nulls":3},"Nagoya, Aichi, Japan Nagoya University HospitalNagoya, Aichi, Japan Fujita Health University HospitalToyoake, Aichi, Japan|Kashiwa, Chiba, Japan|Chiba, Japan Kyushu University HospitalFukuoka, Japan National Hospital Organization Kyushu Cancer CenterFukuoka, Japan Kyoto University HospitalKyoto, Japan Niigata Cancer Center HospitalNiigata, Japan Okayama University HospitalOkayama, Japan Osaka City General HospitalOsaka, Japan Osaka International Cancer InstituteOsaka, Japan Wakayama Medical University HospitalWakayama, Japan|Matsuyama, Ehime, Japan|Kurume, Fukuoka, Japan|Sapporo, Hokkaido, Japan|Akashi, Hyogo, Japan Kobe City Medical Center General HospitalKobe, Hyogo, Japan|Kanazawa, Ishikawa, Japan|Morioka, Iwate, Japan|Yokohama, Kanagawa, Japan|Matsuzaka, Mie, Japan|Sendai, Miyagi, Japan|Kurashiki, Okayama, Japan|Hirakata, Osaka, Japan Kindai University HospitalOsakasayama, Osaka, Japan|Ina, Saitama, Japan|Nagaizumi-Cho, Shizuoka, Japan|Shimotsuke, Tochigi, Japan|Bunkyo-Ku, Tokyo, Japan Tokyo Metropolitan Cancer And Infectious Diseases Center Komagome HospitalBunkyo-Ku, Tokyo, Japan National Cancer Center HospitalChuo-Ku, Tokyo, Japan Cancer Institute HospitalKoto-Ku, Tokyo, Japan",null,"Japan","Aichi Aichi Cancer Center Hospital|Chiba National Cancer Center Hospital East|Chiba University Hospital|Ehime National Hospital Organization Shikoku Cancer Center|Fukuoka Kurume University Hospital|Hokkaido Hokkaido Cancer Center|Hyogo Hyogo Cancer Center|Ishikawa Kanazawa University Hospital|Iwate Iwate Medical University Hospital|Kanagawa Kanagawa Cancer Center|Mie Matsuzaka Citizen's Hospital|Miyagi Sendai Kousei Hospital|Okayama Kurashiki Central Hospital|Osaka Kansai Medical University Hospital|Saitama Saitama Cancer Center|Shizuoka Shizuoka Cancer Center|Tochigi Jichi Medical University Hospital|Tokyo Juntendo University Hospital",{"$nulls":3},"Study Director","2019-11-29","2020-05-25T16:38:39.387","2020-05-26T17:10:42.972","NCT03410108"]
["5ecbf48ffe30261b1a048347","NCT03410693","2018-05-16","Bayer","BAYN","Recruiting","Study of Rogaratinib (BAY1163877) vs Chemotherapy in Patients With FGFR (Fibroblast Growth Factor Receptor)-Positive Locally Advanced or Metastatic Urothelial Carcinoma (FORT-1)","Bay-1163877",null,"Yes","['Bay-1163877']","Unknown",null,"Phase 2/Phase 3",2,400,"Anticipated","2018-05-09","2022-04-25","OS","Overall Survival",{"$nulls":3},"This is a randomized, open-label, multicenter Phase 2/3 study to evaluate the efficacy and safety of rogaratinib (BAY 1163877) compared to chemotherapy in patients with FGFRpositive locally advanced or metastatic urothelial carcinoma who have received Prior platinum-containing chemotherapy.\n\nThe primary objective of the entire study is to compare rogaratinib (BAY1163877) with chemotherapy (docetaxel, paclitaxel or vinflunine) in terms of prolonging the Overall survival (OS) of patients with FGFR positive urothelial carcinoma.\n\nAt randomization, patients will have locally advanced or metastatic urothelial carcinoma and have received at least one prior platinum-containing chemotherapy regimen. Only patients with FGFR1 or 3 positive tumors can be randomized into the study. Archival tumor tissue is adequate for testing of FGFR1 and 3 mRNA expressions, which will be determined centrally using an RNA in situ hybridization (RNA-ISH) test. Approximately 42 % of UC patients with locally advanced or metastatic UC are identified as FGFR-positive by the RNA-ISH cut-off applied.",null,"A Randomized, Open Label, Multicenter Phase 2/3 Study to Evaluate the Efficacy and Safety of Rogaratinib (BAY1163877) Compared to Chemotherapy in Patients With FGFR-positive Locally Advanced or Metastatic Urothelial Carcinoma Who Have Received Prior Platinum-containing Chemotherapy",17403,"Carcinoma, Transitional Cell","Noma|Carcinoma|Transitional Cell Carcinoma","Mouth Diseases|Oncology Solid Tumor","Ear, Nose and Throat|Oncology","Experimental|Active Comparator","Rogaratinib|Chemotherapy",null,"Drug","Rogaratinib (BAY1163877)|Chemotherapy","Rogaratinib administered as oral (p.o.) tablets twice daily (b.i.d.) continuously|Chemotherapy as taxane (docetaxel or paclitaxel) or vinflunine administered through intravenous (i.v.) infusion every 3 weeks (on day 1 of a 21-day cycle) The choice of the chemotherapy is at the discretion of the investigator, taking into consideration the status of the authorization in the given Country (i.e. the drug has to be approved at least for one indication in the given country).",null,"Rogaratinib|Chemotherapy","\n\n * Existence of archival or fresh biopsy for FGFR testing\n * FGFR testing of patients will be performed at the investigators' discretion up to a max. of 90 days prior to start of screening.\n\nInvestigators should ensure all patients will be eligible in terms of disease status and lines of treatment within this timeframe.\n\n * Documented urothelial carcinoma (transitional cell carcinoma) including urinary bladder, renal pelvis, ureters, urethra meeting all of the following criteria * Histologically or cytologically confirmed (patients with mixed histologies are required to have a dominant transitional cell pattern.)\n    * Locally advanced (T4b, any N; or any T, N 2âˆ’3) or metastatic disease (any T, any N and M1). Locally advanced bladder cancer must be unresectable i.e. invading the pelvic or abdominal wall (stage T4b) or presenting with bulky nodal disease (N2-3).\n   \n   \n * ECOG (Eastern Cooperative Oncology Group) Performance Status of 0 or 1\n * Disease progression during or following treatment with at least one platinum-containing regimen (patients should have been treated for at least 2 cycles). In patients who received prior adjuvant/ neoadjuvant platinum-containing chemotherapy, progression had to occur within 12 months of treatment.\n * High FGFR1 or 3 mRNA (Messenger ribonucleic acid) expression levels (RNAscope score of 3+ or 4+; measurement is part of this protocol) in archival or fresh Tumor biopsy specimen\n * At least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST v.1.1) in contrast enhanced (unless contraindicated) CT or MRI\n\n","\n\n * Previous or concurrent cancer except * cervical carcinoma in situ\n    * treated basal-cell or squamous cell skin carcinoma\n    * any cancer curatively treated > 3 years before randomization\n    * curatively treated incidental prostate cancer (T1/T2a)\n   \n   \n * Ongoing or previous anti-cancer treatment within 4 weeks before randomization.\n * More than two prior lines of systemic anti-cancer therapy for urothelial carcinoma\n * Ongoing or previous treatment with anti-FGFR directed therapies (e.g. receptor tyrosine kinase inhibitors including rogaratinib or FGFRspecific antibodies) or with taxanes or vinflunine\n * Unresolved toxicity higher than National Cancer Institute's Common Terminology Criteria for Adverse Events, version 4.03 (CTCAE v.4.03) Grade 1 attributed to any prior therapy/ procedure excluding alopecia, anemia and/ or hypothyroidism\n * History or current condition of an uncontrolled cardiovascular disease including any of the following conditions: * Congestive heart failure (CHF) NYHA (New York Heart Association) > Class 2\n    * Unstable angina (symptoms of angina at rest) or new-onset angina (within last 3 months before randomization)\n    * Myocardial infarction (MI) within past 6 months before randomization\n    * Unstable cardiac arrhythmias requiring anti-arrhythmic therapy. Patients with arrhythmia under control with anti-arrhythmic therapy such as beta-blockers or digoxin are eligible.\n   \n   \n * Arterial or venous thrombotic events or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within 3 months before randomization\n * Current evidence of endocrine alteration of calcium phosphate homeostasis (e.g. parathyroid disorder, history of parathyroidectomy, tumor lysis, tumoral calcinosis, paraneoplastic hypercalcemia)\n * Any hemorrhage / bleeding event â‰¥ CTCAE v.4.03 Grade 3 within 4 weeks before randomization\n * Current diagnosis of any retinal detachment, retinal pigment epithelial detachment (RPED), serous retinopathy or retinal vein occlusion",{"$nulls":4},"Actual","2018-01-25","Actual","Anticipated","2022-04-25","Anticipated","2018-05-01","2018-01-19","2018-01-19","2018-05-11","Yes","Urothelial carcinoma","Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"2016-004340-11","EudraCT Number","Overall Survival","Defined as the time (days) from randomization to death due to any cause. Patients alive at the date of data cut-off for analysis will be censored at the last date known to be alive.","Up to 45 months","Progression-free survival (PFS)|Objective response rate (ORR)|Disease-control rate (DCR)|Duration of response (DOR)|Incidence of Adverse Events as a measure of safety and tolerability","Defined as the time (days) from randomization to date of first observed disease progression (radiological or clinical assessment) or death due to any cause, if death occurs before progression is documented. For patients without documented radiological or clinical progression or death at the time of analysis, PFS will be censored at the last actual visit date of tumor evaluation.|Defined as the percentage of patients with complete response (CR) or partial Response (PR). Patients for whom overall best response is not CR or PR, as well as patients without any post-baseline tumor assessment will be considered non-responders.|Defined as the percentage of patients, whose overall best response was not progressive disease|Defined as the time from the first documented objective response of PR or CR, whichever is noted earlier, to disease progression or death (if death occurs before progression is documented). DOR will be defined for responders only, i.e. patients with a CR or PR.|Up to 45 months","Up to 45 months|PD (i.e. CR, PR, Stable Disease","clinical-trials-contact@bayer.com","Bayer Clinical Trials Contact","(+) 1-888-8422937","Coffs Harbour, New South Wales, Australia, 2450 Northern Cancer InstituteSt Leonards, New South Wales, Australia, 2065 Riverina Cancer Care CentreWagga Wagga, New South Wales, Australia, 2650 Sydney Adventist HospitalWahroonga, New South Wales, Australia, 2076|Benowa, Queensland, Australia, 4217|East Bentleigh, Victoria, Australia, 3165|Krems, Austria, 3500 Krankenhaus Der Barmherzigen BrÃ¼derWien, Austria, 1020 Allgemeines Krankenhaus Der Stadt WienWien, Austria, 1090 Wilhelminenspital Der Stadt WienWien, Austria, 1160|Linz, OberÃ¶sterreich, Austria, 4010|Graz, Steiermark, Austria, 8036|Gent, Belgium, 9000 Ch De Jolimont - Lobbes Site De JolimontLa Louviere, Belgium, 7100 Uz Leuven GasthuisbergLeuven, Belgium, 3000 Chu De LiÃ¨geLiege, Belgium, 4000 Clinique Saint-PierreOttignies, Belgium, 1340|Porto Alegre, Rio Grande Do Sul, Brazil, 90050 170|Barretos, Sao Paulo, Brazil, 14784400 Hosp ClÃ­nicas Facult. Med. De RibeirÃ£o Preto / UspRibeirÃ£o Preto, Sao Paulo, Brazil, 14048-900 Hospital De Base Da FundaÃ§Ã£o F M S J Rio PretoSÃ£o JosÃ© Do Rio Preto, Sao Paulo, Brazil|Hamilton, Ontario, Canada, L8V 5C2 London Regional Cancer ProgramLondon, Ontario, Canada, N6A 4L6 Princess Margaret Hospital-University Health NetworkToronto, Ontario, Canada, M5G 2M9|Ottawa, Canada, K1H 8L6|Montreal, Quebec, Canada, H3T 1E2|Taichung, Taiwan, 40447 Taichung Veterans General HospitalTaichung, Taiwan, 40705 National Cheng Kung University HospitalTainan, Taiwan National Taiwan University HospitalTaipei, Taiwan, 10002 Taipei Veterans General HospitalTaipei, Taiwan, 11217 Chang Gung Memorial Hospital At LinkouTaoyuan, Taiwan, 333|Olomouc, Czechia, 775 20 Fakultni Nemocnice OstravaOstrava, Czechia, 708 52 Fakultni Nemocnice Kralovske VinohradyPraha 10, Czechia, 10034 Fakultni Thomayerova NemocnicePraha 4 - Krc, Czechia, 140 59|Aarhus N, Denmark, 8200 Herlev HospitalHerlev, Denmark, 2730 H:S RigshospitaletKÃ¸benhavn, Denmark, 2100|Helsinki, Finland, 00180 Tampereen Yliopistollinen Sairaala, KeskussairaalaTampere, Finland, Fin-33520|Besancon, France, 25030 HÃ´pital Saint AndrÃ© - BordeauxBordeaux, France, 33000 Centre FranÃ§ois Baclesse - ClccCaen Cedex 5, France, 14076 Centre Jean PerrinClermont Ferrand Cedex 1, France, 63011 Centre Oscar Lambret - LilleLille Cedex, France, 59020 Centre LÃ©on BÃ©rardLyon Cedex, France, 69008 Institut Paoli-Calmettes - MarseilleMarseille, France, 13273 HÃ´pital Saint Louis - ParisParis, France, 75010 Cochin - ParisParis, France, 75674 HÃ´pital D'Instruction Des ArmÃ©es BeginSaint Mande, France, 94160 Clinique Saint Anne - StrasbourgStrasbourg, France, 67000 Centre MÃ©dico-Chirurgical FochSuresnes, France, 92151|Freiburg, Baden-WÃ¼rttemberg, Germany, 79106 Klinikum Der Eberhard-Karls-UniversitÃ¤t TÃ¼bingenTÃ¼bingen, Baden-WÃ¼rttemberg, Germany, 72076 UniversitÃ¤tsklinikum UlmUlm, Baden-WÃ¼rttemberg, Germany, 89075|Erlangen, Bayern, Germany, 91054|DÃ¼sseldorf, Nordrhein-Westfalen, Germany, 40225 UniversitÃ¤tsklinikum KÃ¶lnKÃ¶ln, Nordrhein-Westfalen, Germany, 50937|Mainz, Rheinland-Pfalz, Germany, 55131|Dresden, Sachsen, Germany, 01307|Berlin, Germany, 10967 Medizinische FakultÃ¤t Der Otto-Von-Guericke UniversitÃ¤tMagdeburg, Germany, 39120 Hong Kong Queen Mary HospitalHong Kong, Hong Kong Princess Margaret HospitalKowloon, Hong Kong Queen Elizabeth HospitalKowloon, Hong Kong Prince Of Wales HospitalShatin, Hong Kong|Budapest, Hungary, 1062 Semmelweis EgyetemBudapest, Hungary, 1082 Bajcsy Zsilinszky Korhaz-RendelointezetBudapest, Hungary, 1106 Orszagos Onkologiai IntezetBudapest, Hungary, 1122 Debreceni Egyetem Klinikai KozpontDebrecen, Hungary, 4032 Pecsi Tudomanyegyetem Klinikai KozpontPecs, Hungary, 7624|Cork, Ireland AmnchDublin, Ireland, 24 Mater Misericordiae University HospitalDublin, Ireland, 7 Mater Private HospitalDublin, Ireland, 7|Haifa, Israel, 3109601 Hadassah Hebrew University Hospital Ein KeremJerusalem, Israel, 9112001 Meir Medical CenterKfar Saba, Israel, 4428164 Rabin Medical Center - Beilinson CampusPetah Tikva, Israel, 4941492 Chaim Sheba Medical CenterRamat Gan, Israel, 5266202|ForlÃ¬-Cesena, Emilia-Romagna, Italy, 47014 Ausl ModenaModena, Emilia-Romagna, Italy, 41012 A.O.U. Di Modena - PoliclinicoModena, Emilia-Romagna, Italy, 41124|Roma, Lazio, Italy, 00128 A.O. San Camillo-ForlaniniRoma, Lazio, Italy, 00152 Fond. Policlinico Universitario A. GemelliRoma, Lazio, Italy, 00168|Milano, Lombardia, Italy, 20133 Irccs Istituto Europeo Oncologia (Ieo)Milano, Lombardia, Italy, 20141 Asst Grande Ospedale Metropolitano NiguardaMilano, Lombardia, Italy, 20162|Torino, Piemonte, Italy, 10043|Pisa, Toscana, Italy, 56126|Verona, Veneto, Italy, 37134|Nagoya, Aichi, Japan, 466-8560|Akita, Japan, 010-8543 Kyushu University HospitalFukuoka, Japan, 812-8582 Hiroshima City Hiroshima Citizens HospitalHiroshima, Japan, 730-8518 Kumamoto University HospitalKumamoto, Japan, 860-8556 Niigata University Medical And Dental HospitalNiigata, Japan, 951-8520 Osaka International Cancer InstituteOsaka, Japan, 541-8567 Tokushima University HospitalTokushima, Japan, 770-8503 Toyama University HospitalToyama, Japan, 930-0194 Korea, Republic Of, Gyeonggido National Cancer CenterGoyang-Si, Gyeonggido, Korea, Republic Of, 410-769 Korea, Republic Of Yonsei University College Of MedicineSeoul, Korea, Republic Of, 120-752 Samsung Medical CenterSeoul, Korea, Republic Of, 135-710 Asan Medical CenterSeoul, Korea, Republic Of, 138-736|Hirosaki, Aomori, Japan, 036-8563|Matsuyama, Ehime, Japan, 791-0280|Maebashi, Gunma, Japan, 371-8511 Gunma Prefectural Cancer CenterOta, Gunma, Japan, 373-8550|Sapporo, Hokkaido, Japan, 060-8543 Hokkaido University HospitalSapporo, Hokkaido, Japan, 060-8648|Kobe, Hyogo, Japan, 650-0047|Tsukuba, Ibaraki, Japan, 305-8576|Morioka, Iwate, Japan, 020-8505|Yokohama, Kanagawa, Japan, 236-0004|Osakasayama, Osaka, Japan, 589-8511|Hidaka, Saitama, Japan, 350-1298|Bunkyo-Ku, Tokyo, Japan, 113-8603 National Cancer Center HospitalChuo-Ku, Tokyo, Japan, 104-0045 The Cancer Institute Hospital Of JfcrKoto-Ku, Tokyo, Japan, 135-8550 Keio University HospitalShinjuku-Ku, Tokyo, Japan, 160-8582|Amsterdam, Netherlands, 1066 Cx Universitair Medisch Centrum St. RadboudNijmegen, Netherlands, 6525 Ga Erasmus Medisch CentrumRotterdam, Netherlands, 3075 Ea|Bydgoszcz, Poland, 85-796 Swietokrzyskie Centrum OnkologiiKielce, Poland, 25-734 Przychodnia Lekarska KomedKonin, Poland, 62-500 Salve Medica Sp. Z O.O. Sp.K.Lodz, Poland, 91-211 Samodzielny Publiczny Zespol Gruzlicy I Chorob PlucOlsztyn, Poland, 10-357 Sp Szpital Kliniczny Nr 2Poznan, Poland, 60-569 Uroprojekt S.C. - Gabinet UrologicznySiedlce, Poland, 08-110 Centralny Szpital Kliniczny Mswia W WarszawieWarszawa, Poland, 02-507 Uniwersytecki Szpital Kliniczny Im. J. Mikulicza-RadeckiegoWroclaw, Poland, 50-556|Coimbra, Portugal, 3000-075 Instituto PortuguÃªs Oncologia - CoimbraCoimbra, Portugal, 3000-075 Hospital Cuf Infante SantoLisboa, Portugal, 1350-070 Centro Hospitalar De Lisboa Norte - Hospital Santa MariaLisboa, Portugal, 1649-035 Centro Hospitalar Do Porto, EpePorto, Portugal, 4099-001 Russian Federation Krasnoyarsk Regional Clinical Oncology DispensaryKrasnoyarsk, Russian Federation, 660133 Moscow Scient. Res. Institute Of Oncology N.A P.A. HertzenMoscow, Russian Federation, 125284 Urological Center PomcNizhny Novgorod, Russian Federation, 603109 Medical Center \"Avicenna\"Novosibirsk, Russian Federation, 630099 Clinical Oncological Dispensary Of Omsk RegionOmsk, Russian Federation, 644013 Samara Regional Clinical Oncology DispensarySamara, Russian Federation, 443031 Bashkir State Medical UniversityUfa, Russian Federation, 450008|Loures, Lisboa, Portugal, 2674-514|Bratislava, Slovakia, 833 10 Uroexam, Spol. S R.O.Nitra, Slovakia, 949 01 Poko Poprad S.R.O.Poprad, Slovakia, 085 01|CÃ³rdoba, AndalucÃ­a, Spain, 14004|Badalona, Barcelona, Spain, 08916 Institut CatalÃ  D'Oncologia HospitaletL'Hospitalet De Llobregat, Barcelona, Spain, 08907|Barcelona, Catalunya, Spain, 08003|Barcelona, Spain, 08035 Hospital San Pedro De AlcÃ¡ntaraCÃ¡ceres, Spain, 10003 Md Anderson International Espanya, S.A.Madrid, Spain, 28033 Hospital RamÃ³n Y CajalMadrid, Spain, 28034 Hospital Universitario 12 De OctubreMadrid, Spain, 28041 Hospital Virgen De La VictoriaMÃ¡laga, Spain, 29010 Instituto Valenciano De OncologÃ­aValencia, Spain, 46009 Hospital General Universitario De ValenciaValencia, Spain, 46014|Palma De Mallorca, Illes Baleares, Spain, 07120|Stockholm, Sweden, 118 83 Karolinska InstitutetStockholm, Sweden, 17167 Norrlands Universitetssjukhus, UmeÃ¥UmeÃ¥, Sweden, 901 85|Basel, Basel-Stadt, Switzerland, 4031|Chur, GraubÃ¼nden, Switzerland, 7000|Bern, Switzerland, 3010 Taiwan|St. Gallen, Sankt Gallen, Switzerland, 9007|Taunton, Somerset, United Kingdom, Ta1 5Da|London, United Kingdom, Sw3 6Jj|Anchorage, Alaska, United States, 99503|Phoenix, Arizona, United States, 85004 University Of Arizona Cancer CenterTucson, Arizona, United States, 85724|Sacramento, California, United States, 95817|New York, New York, United States, 10016-4576 Memorial Sloan-Kettering Cancer CenterNew York, New York, United States, 10021|Oklahoma City, Oklahoma, United States, 73104|Greenville, South Carolina, United States, 29607 Carolina Urological Research CenterMyrtle Beach, South Carolina, United States, 29572|Watertown, South Dakota, United States, 57201|Houston, Texas, United States, 77030-2707|Seattle, Washington, United States, 98101","Alaska|Arizona|California|New York|Oklahoma|South Carolina|South Dakota|Texas|Washington","Australia|Austria|Belgium|Brazil|Canada|China|Czechia|Denmark|Finland|France|Germany|Hungary|Ireland|Israel|Italy|Japan|Netherlands|Poland|Portugal|Slovakia|Spain|Sweden|Switzerland|United Kingdom|United States","New South Wales Mid North Coast Cancer Institute|Queensland Pindara Private Hospital|Victoria Monash Cancer Centre|Landesklinikum Krems|OberÃ¶sterreich Krankenhaus Der Barmherzigen Schwestern Linz|Steiermark Medizinische UniversitÃ¤t Graz|Uz Gent|Rio Grande Do Sul Irmandade Santa Casa De Misericordia De Porto Alegre|Sao Paulo FundaÃ§Ã£o Pio Xii - Hospital De CÃ¢ncer De Barretos|Ontario Juravinski Cancer Centre|Ottawa Hospital-General Campus|Quebec Sir Mortimer B. Davis Jewish General Hospital|Medical University Hospital|Fakultni Nemocnice Olomouc|Aarhus Universitetshospital, Skejby|Docrates Klinikka|Hopital J. Minjoz - BesanÃ§on|Baden-WÃ¼rttemberg UniversitÃ¤tsklinikum Freiburg|Bayern UniversitÃ¤tsklinikum Erlangen|Nordrhein-Westfalen Heinrich-Heine-UniversitÃ¤t|Rheinland-Pfalz UniversitÃ¤tsmedizin Der Johannes Gutenberg UniversitÃ¤t Mainz|Sachsen Medizinische FakultÃ¤t Carl Gustav Carus|Vivantes Klinikum Am Urban|Mh Egeszsegugyi Kozpont|Cork University Hospital|Rambam Health Corporation|Emilia-Romagna Irst Istituto Scientifico Romagnolo Per Studio E Cura Tumori|Lazio Policlinico Universitario Campus Biomedico|Lombardia Fondazione Irccs Istituto Nazionale Dei Tumori|Piemonte A.O.U. San Luigi Gonzaga|Toscana A.O.U. Pisana|Veneto A.O.U. Integrata Verona|Aichi Nagoya University Hospital|Akita University Hospital|Aomori Hirosaki University Hospital|Ehime National Hospital Organization Shikoku Cancer Center|Gunma Gunma University Hospital|Hokkaido Sapporo Medical University Hospital|Hyogo Kobe City Medical Center General Hospital|Ibaraki University Of Tsukuba Hospital|Iwate Iwate Medical University Hospital|Kanagawa Yokohama City University Hospital|Osaka Kindai University Hospital|Saitama Saitama Medical University International Medical Center|Tokyo Nippon Medical School Hospital|Nederlands Kanker Instituut|Centrum Onkologii Im. Prof. Franciszka Lukaszczyka|Centro Hospitalar E UniversitÃ¡rio De Coimbra|Lisboa Hospital Beatriz Angelo|Narodny Onkologicky Ustav|AndalucÃ­a Hospital Reina SofÃ­a|Barcelona Institut CatalÃ  D'Oncologia Badalona|Catalunya Hospital Del Mar|Ciutat SanitÃ ria I Universitaria De La Vall D'Hebron|Illes Baleares Hospital Universitari Son Espases|SÃ¶dersjukhuset|Basel-Stadt UniversitÃ¤tsspital Basel|GraubÃ¼nden Kantonsspital GraubÃ¼nden|Inselspital UniversitÃ¤tsspital Bern|Sankt Gallen Kantonsspital St. Gallen|, Somerset Musgrove Park Hospital|The Royal Marsden Hospital|Alaska Clinical Research Center, Llc|Univeristy Of Arizona Cancer Center|Uc Davis Comprehensive Cancer Center|Nyu Langone Medical Center|Oklahoma University Health Science Center|Bon Secours St. Francis Hospital|Prairie Lakes Cancer Center|Houston Methodist Hospital|Virginia Mason Medical Center",{"$nulls":3},"Bayer Study Director","2018-05-11","2020-05-25T16:38:39.738","2020-05-26T17:10:42.972","NCT03410693"]
["5ecbf48ffeab101b15530976","NCT03410693","2018-07-10","Bayer","BAYN","Recruiting","Study of Rogaratinib (BAY1163877) vs Chemotherapy in Patients With FGFR (Fibroblast Growth Factor Receptor)-Positive Locally Advanced or Metastatic Urothelial Carcinoma (FORT-1)","Bay-1163877",null,"Yes","['Bay-1163877']","Unknown",null,"Phase 2/Phase 3",2,400,"Anticipated","2018-05-31","2022-04-25","OS","Overall Survival",{"$nulls":3},"This is a randomized, open-label, multicenter Phase 2/3 study to evaluate the efficacy and safety of rogaratinib (BAY 1163877) compared to chemotherapy in patients with FGFRpositive locally advanced or metastatic urothelial carcinoma who have received Prior platinum-containing chemotherapy.\n\nThe primary objective of the entire study is to compare rogaratinib (BAY1163877) with chemotherapy (docetaxel, paclitaxel or vinflunine) in terms of prolonging the Overall survival (OS) of patients with FGFR positive urothelial carcinoma.\n\nAt randomization, patients will have locally advanced or metastatic urothelial carcinoma and have received at least one prior platinum-containing chemotherapy regimen. Only patients with FGFR1 or 3 positive tumors can be randomized into the study. Archival tumor tissue is adequate for testing of FGFR1 and 3 mRNA expressions, which will be determined centrally using an RNA in situ hybridization (RNA-ISH) test. Approximately 42 % of UC patients with locally advanced or metastatic UC are identified as FGFR-positive by the RNA-ISH cut-off applied.",null,"A Randomized, Open Label, Multicenter Phase 2/3 Study to Evaluate the Efficacy and Safety of Rogaratinib (BAY1163877) Compared to Chemotherapy in Patients With FGFR-positive Locally Advanced or Metastatic Urothelial Carcinoma Who Have Received Prior Platinum-containing Chemotherapy",17403,"Carcinoma, Transitional Cell","Noma|Carcinoma|Transitional Cell Carcinoma","Mouth Diseases|Oncology Solid Tumor","Ear, Nose and Throat|Oncology","Experimental|Active Comparator","Rogaratinib|Chemotherapy",null,"Drug","Rogaratinib (BAY1163877)|Chemotherapy","Rogaratinib administered as oral (p.o.) tablets twice daily (b.i.d.) continuously|Chemotherapy as taxane (docetaxel or paclitaxel) or vinflunine administered through intravenous (i.v.) infusion every 3 weeks (on day 1 of a 21-day cycle) The choice of the chemotherapy is at the discretion of the investigator, taking into consideration the status of the authorization in the given Country (i.e. the drug has to be approved at least for one indication in the given country).",null,"Rogaratinib|Chemotherapy","\n\n * Existence of archival or fresh biopsy for FGFR testing\n * FGFR testing of patients will be performed at the investigators' discretion up to a max. of 90 days prior to start of screening.\n\nInvestigators should ensure all patients will be eligible in terms of disease status and lines of treatment within this timeframe.\n\n * Documented urothelial carcinoma (transitional cell carcinoma) including urinary bladder, renal pelvis, ureters, urethra meeting all of the following criteria * Histologically or cytologically confirmed (patients with mixed histologies are required to have a dominant transitional cell pattern.)\n    * Locally advanced (T4b, any N; or any T, N 2âˆ’3) or metastatic disease (any T, any N and M1). Locally advanced bladder cancer must be unresectable i.e. invading the pelvic or abdominal wall (stage T4b) or presenting with bulky nodal disease (N2-3).\n   \n   \n * ECOG (Eastern Cooperative Oncology Group) Performance Status of 0 or 1\n * Disease progression during or following treatment with at least one platinum-containing regimen (patients should have been treated for at least 2 cycles). In patients who received prior adjuvant/ neoadjuvant platinum-containing chemotherapy, progression had to occur within 12 months of treatment.\n * High FGFR1 or 3 mRNA (Messenger ribonucleic acid) expression levels (RNAscope score of 3+ or 4+; measurement is part of this protocol) in archival or fresh Tumor biopsy specimen\n * At least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST v.1.1) in contrast enhanced (unless contraindicated) CT or MRI\n\n","\n\n * Previous or concurrent cancer except * cervical carcinoma in situ\n    * treated basal-cell or squamous cell skin carcinoma\n    * any cancer curatively treated > 3 years before randomization\n    * curatively treated incidental prostate cancer (T1/T2a)\n   \n   \n * Ongoing or previous anti-cancer treatment within 4 weeks before randomization.\n * More than two prior lines of systemic anti-cancer therapy for urothelial carcinoma\n * Ongoing or previous treatment with anti-FGFR directed therapies (e.g. receptor tyrosine kinase inhibitors including rogaratinib or FGFRspecific antibodies) or with taxanes or vinflunine\n * Unresolved toxicity higher than National Cancer Institute's Common Terminology Criteria for Adverse Events, version 4.03 (CTCAE v.4.03) Grade 1 attributed to any prior therapy/ procedure excluding alopecia, anemia and/ or hypothyroidism\n * History or current condition of an uncontrolled cardiovascular disease including any of the following conditions: * Congestive heart failure (CHF) NYHA (New York Heart Association) > Class 2\n    * Unstable angina (symptoms of angina at rest) or new-onset angina (within last 3 months before randomization)\n    * Myocardial infarction (MI) within past 6 months before randomization\n    * Unstable cardiac arrhythmias requiring anti-arrhythmic therapy. Patients with arrhythmia under control with anti-arrhythmic therapy such as beta-blockers or digoxin are eligible.\n   \n   \n * Arterial or venous thrombotic events or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within 3 months before randomization\n * Current evidence of endocrine alteration of calcium phosphate homeostasis (e.g. parathyroid disorder, history of parathyroidectomy, tumor lysis, tumoral calcinosis, paraneoplastic hypercalcemia)\n * Any hemorrhage / bleeding event â‰¥ CTCAE v.4.03 Grade 3 within 4 weeks before randomization\n * Current diagnosis of any retinal detachment, retinal pigment epithelial detachment (RPED), serous retinopathy or retinal vein occlusion",{"$nulls":4},"Actual","2018-01-25","Actual","Anticipated","2022-04-25","Anticipated","2018-07-01","2018-01-19","2018-01-19","2018-07-09","Yes","Urothelial carcinoma","Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"2016-004340-11","EudraCT Number","Overall Survival","Defined as the time (days) from randomization to death due to any cause. Patients alive at the date of data cut-off for analysis will be censored at the last date known to be alive.","Up to 45 months","Progression-free survival (PFS)|Objective response rate (ORR)|Disease-control rate (DCR)|Duration of response (DOR)|Incidence of Adverse Events as a measure of safety and tolerability","Defined as the time (days) from randomization to date of first observed disease progression (radiological or clinical assessment) or death due to any cause, if death occurs before progression is documented. For patients without documented radiological or clinical progression or death at the time of analysis, PFS will be censored at the last actual visit date of tumor evaluation.|Defined as the percentage of patients with complete response (CR) or partial Response (PR). Patients for whom overall best response is not CR or PR, as well as patients without any post-baseline tumor assessment will be considered non-responders.|Defined as the percentage of patients, whose overall best response was not progressive disease|Defined as the time from the first documented objective response of PR or CR, whichever is noted earlier, to disease progression or death (if death occurs before progression is documented). DOR will be defined for responders only, i.e. patients with a CR or PR.|Up to 45 months","Up to 45 months|PD (i.e. CR, PR, Stable Disease","clinical-trials-contact@bayer.com","Bayer Clinical Trials Contact","(+) 1-888-8422937","Coffs Harbour, New South Wales, Australia, 2450 Northern Cancer InstituteSt Leonards, New South Wales, Australia, 2065 Riverina Cancer Care CentreWagga Wagga, New South Wales, Australia, 2650 Sydney Adventist HospitalWahroonga, New South Wales, Australia, 2076|Benowa, Queensland, Australia, 4217|East Bentleigh, Victoria, Australia, 3165|Krems, Austria, 3500 Krankenhaus Der Barmherzigen BrÃ¼derWien, Austria, 1020 Allgemeines Krankenhaus Der Stadt WienWien, Austria, 1090 Wilhelminenspital Der Stadt WienWien, Austria, 1160|Linz, OberÃ¶sterreich, Austria, 4010|Graz, Steiermark, Austria, 8036|Gent, Belgium, 9000 Ch De Jolimont - Lobbes Site De JolimontLa Louviere, Belgium, 7100 Uz Leuven GasthuisbergLeuven, Belgium, 3000 Chu De LiÃ¨geLiege, Belgium, 4000 Clinique Saint-PierreOttignies, Belgium, 1340|Porto Alegre, Rio Grande Do Sul, Brazil, 90050 170|Barretos, Sao Paulo, Brazil, 14784400 Hosp ClÃ­nicas Facult. Med. De RibeirÃ£o Preto / UspRibeirÃ£o Preto, Sao Paulo, Brazil, 14048-900 Hospital De Base Da FundaÃ§Ã£o F M S J Rio PretoSÃ£o JosÃ© Do Rio Preto, Sao Paulo, Brazil|Hamilton, Ontario, Canada, L8V 5C2 London Regional Cancer ProgramLondon, Ontario, Canada, N6A 4L6 Princess Margaret Hospital-University Health NetworkToronto, Ontario, Canada, M5G 2M9|Ottawa, Canada, K1H 8L6|Montreal, Quebec, Canada, H3T 1E2|Hefei, Anhui, China, 230001|Beijing, China, 100050 The 307Th Hospital Of Chinese People'S Liberation ArmyBeijing, China, 100071 Peking University Third HospitalBeijing, China, 100191 Beijing HospitalBeijing, China, 100730 Peking Union Medical College Hospital CamsBeijing, China, 100730 Chongqing Cancer HospitalChongqing, China, 400030 Fudan University Shanghai Cancer CenterShanghai, China, 200032 Zhongshan Hospital, Fudan UniversityShanghai, China, 200032 Huadong Hospital, Affiliated To Fudan UniversityShanghai, China, 200040 Tianjin Medical University Cancer Institiute & HospitalTianjin, China, 300060|Fuzhou, Fujian, China, 350001 The First Affiliated Hospital Of Xiamen UniversityXiamen, Fujian, China, 361003|Guangzhou, Guangdong, China, 510060 First Affiliated Hospital Of Guangzhou Medical UniversityGuangzhou, Guangdong, China, 510120|Shijiazhuang, Hebei, China, 050000|Chengdu, Sichuan, China, 610041 The First Hospital To AmuChongqing, Sichuan, China, 400038|Wuhan, Hubei, China, 430079|Changsha, Hunan, China, 410013|Nanjing, Jiangsu, China, 210008 Jiangsu Cancer HospitalNanjing, Jiangsu, China, 210009|Nanchang, Jiangxi, China, 330006|Changchun, Jilin, China, 130021|Shengyang, Liaoning, China, 110042|Taichung, Taiwan, 40447 Taichung Veterans General HospitalTaichung, Taiwan, 40705 National Cheng Kung University HospitalTainan, Taiwan National Taiwan University HospitalTaipei, Taiwan, 10002 Taipei Veterans General HospitalTaipei, Taiwan, 11217 Chang Gung Memorial Hospital At LinkouTaoyuan, Taiwan, 333|Xi'An, Shaanxi, China, 710061|Hangzhou, Zhejiang, China, 310014 The First Affiliated Hospital Of Wenzhou Medical UniversityWenzhou, Zhejiang, China, 325000|Olomouc, Czechia, 775 20 Fakultni Nemocnice OstravaOstrava, Czechia, 708 52 Fakultni Nemocnice Kralovske VinohradyPraha 10, Czechia, 10034 Fakultni Thomayerova NemocnicePraha 4 - Krc, Czechia, 140 59 Bata HospitalZlin, Czechia, 762 75|Aarhus N, Denmark, 8200 Herlev HospitalHerlev, Denmark, 2730 H:S RigshospitaletKÃ¸benhavn, Denmark, 2100|Helsinki, Finland, 00180 Tampereen Yliopistollinen Sairaala, KeskussairaalaTampere, Finland, Fin-33520|Besancon, France, 25030 HÃ´pital Saint AndrÃ© - BordeauxBordeaux, France, 33000 Centre FranÃ§ois Baclesse - ClccCaen Cedex 5, France, 14076 Centre Jean PerrinClermont Ferrand Cedex 1, France, 63011 Centre Oscar Lambret - LilleLille Cedex, France, 59020 Centre LÃ©on BÃ©rardLyon Cedex, France, 69008 Institut Paoli-Calmettes - MarseilleMarseille, France, 13273 HÃ´pital Saint Louis - ParisParis, France, 75010 Cochin - ParisParis, France, 75674 HÃ´pital D'Instruction Des ArmÃ©es BeginSaint Mande, France, 94160 Clinique Saint Anne - StrasbourgStrasbourg, France, 67000 Centre MÃ©dico-Chirurgical FochSuresnes, France, 92151|Freiburg, Baden-WÃ¼rttemberg, Germany, 79106 Klinikum Der Eberhard-Karls-UniversitÃ¤t TÃ¼bingenTÃ¼bingen, Baden-WÃ¼rttemberg, Germany, 72076 UniversitÃ¤tsklinikum UlmUlm, Baden-WÃ¼rttemberg, Germany, 89075|Erlangen, Bayern, Germany, 91054|DÃ¼sseldorf, Nordrhein-Westfalen, Germany, 40225 UniversitÃ¤tsklinikum KÃ¶lnKÃ¶ln, Nordrhein-Westfalen, Germany, 50937|Mainz, Rheinland-Pfalz, Germany, 55131|Dresden, Sachsen, Germany, 01307|Berlin, Germany, 10967 Medizinische FakultÃ¤t Der Otto-Von-Guericke UniversitÃ¤tMagdeburg, Germany, 39120 Hong Kong Queen Mary HospitalHong Kong, Hong Kong Princess Margaret HospitalKowloon, Hong Kong Queen Elizabeth HospitalKowloon, Hong Kong Prince Of Wales HospitalShatin, Hong Kong|Budapest, Hungary, 1062 Semmelweis EgyetemBudapest, Hungary, 1082 Bajcsy Zsilinszky Korhaz-RendelointezetBudapest, Hungary, 1106 Orszagos Onkologiai IntezetBudapest, Hungary, 1122 Debreceni Egyetem Klinikai KozpontDebrecen, Hungary, 4032 Pecsi Tudomanyegyetem Klinikai KozpontPecs, Hungary, 7624|Cork, Ireland AmnchDublin, Ireland, 24 Mater Misericordiae University HospitalDublin, Ireland, 7 Mater Private HospitalDublin, Ireland, 7|Haifa, Israel, 3109601 Hadassah Hebrew University Hospital Ein KeremJerusalem, Israel, 9112001 Meir Medical CenterKfar Saba, Israel, 4428164 Rabin Medical Center - Beilinson CampusPetah Tikva, Israel, 4941492 Chaim Sheba Medical CenterRamat Gan, Israel, 5266202|ForlÃ¬-Cesena, Emilia-Romagna, Italy, 47014 Ausl ModenaModena, Emilia-Romagna, Italy, 41012 A.O.U. Di Modena - PoliclinicoModena, Emilia-Romagna, Italy, 41124|Roma, Lazio, Italy, 00128 A.O. San Camillo-ForlaniniRoma, Lazio, Italy, 00152 Fondazione Policlinico Universitario Agostino GemelliRoma, Lazio, Italy, 00168|Milano, Lombardia, Italy, 20133 Irccs Istituto Europeo Oncologia (Ieo)Milano, Lombardia, Italy, 20141 Asst Grande Ospedale Metropolitano NiguardaMilano, Lombardia, Italy, 20162|Torino, Piemonte, Italy, 10043|Bari, Puglia, Italy, 70124|Pisa, Toscana, Italy, 56126|Verona, Veneto, Italy, 37134|Nagoya, Aichi, Japan, 466-8560|Akita, Japan, 010-8543 Kyushu University HospitalFukuoka, Japan, 812-8582 Hiroshima City Hiroshima Citizens HospitalHiroshima, Japan, 730-8518 Kumamoto University HospitalKumamoto, Japan, 860-8556 Niigata University Medical And Dental HospitalNiigata, Japan, 951-8520 Osaka International Cancer InstituteOsaka, Japan, 541-8567 Tokushima University HospitalTokushima, Japan, 770-8503 Toyama University HospitalToyama, Japan, 930-0194 Korea, Republic Of, Gyeonggido National Cancer CenterGoyang-Si, Gyeonggido, Korea, Republic Of, 410-769 Korea, Republic Of Yonsei University College Of MedicineSeoul, Korea, Republic Of, 120-752 Samsung Medical CenterSeoul, Korea, Republic Of, 135-710 Asan Medical CenterSeoul, Korea, Republic Of, 138-736|Hirosaki, Aomori, Japan, 036-8563|Matsuyama, Ehime, Japan, 791-0280|Maebashi, Gunma, Japan, 371-8511 Gunma Prefectural Cancer CenterOta, Gunma, Japan, 373-8550|Sapporo, Hokkaido, Japan, 060-8543 Hokkaido University HospitalSapporo, Hokkaido, Japan, 060-8648|Kobe, Hyogo, Japan, 650-0047|Tsukuba, Ibaraki, Japan, 305-8576|Morioka, Iwate, Japan, 020-8505|Yokohama, Kanagawa, Japan, 236-0004|Osakasayama, Osaka, Japan, 589-8511|Hidaka, Saitama, Japan, 350-1298|Bunkyo-Ku, Tokyo, Japan, 113-8603 National Cancer Center HospitalChuo-Ku, Tokyo, Japan, 104-0045 The Cancer Institute Hospital Of JfcrKoto-Ku, Tokyo, Japan, 135-8550 Keio University HospitalShinjuku-Ku, Tokyo, Japan, 160-8582|Amsterdam, Netherlands, 1066 Cx Universitair Medisch Centrum St. RadboudNijmegen, Netherlands, 6525 Ga Erasmus Medisch CentrumRotterdam, Netherlands, 3075 Ea|Bydgoszcz, Poland, 85-796 Swietokrzyskie Centrum OnkologiiKielce, Poland, 25-734 Przychodnia Lekarska KomedKonin, Poland, 62-500 Salve Medica Sp. Z O.O. Sp.K.Lodz, Poland, 91-211 Samodzielny Publiczny Zespol Gruzlicy I Chorob PlucOlsztyn, Poland, 10-357 Sp Szpital Kliniczny Nr 2Poznan, Poland, 60-569 Uroprojekt S.C. - Gabinet UrologicznySiedlce, Poland, 08-110 Centralny Szpital Kliniczny Mswia W WarszawieWarszawa, Poland, 02-507 Uniwersytecki Szpital Kliniczny Im. J. Mikulicza-RadeckiegoWroclaw, Poland, 50-556|Coimbra, Portugal, 3000-075 Instituto PortuguÃªs Oncologia - CoimbraCoimbra, Portugal, 3000-075 Hospital Cuf Infante SantoLisboa, Portugal, 1350-070 Centro Hospitalar De Lisboa Norte - Hospital Santa MariaLisboa, Portugal, 1649-035 Centro Hospitalar Do Porto, EpePorto, Portugal, 4099-001 Russian Federation Krasnoyarsk Regional Clinical Oncology DispensaryKrasnoyarsk, Russian Federation, 660133 Moscow Scient. Res. Institute Of Oncology N.A P.A. HertzenMoscow, Russian Federation, 125284 Urological Center PomcNizhny Novgorod, Russian Federation, 603109 Medical Center \"Avicenna\"Novosibirsk, Russian Federation, 630099 Medical Center \"Avicenna\"Novosibirsk, Russian Federation, 630099 Clinical Oncological Dispensary Of Omsk RegionOmsk, Russian Federation, 644013 Samara Regional Clinical Oncology DispensarySamara, Russian Federation, 443031 Bashkir State Medical UniversityUfa, Russian Federation, 450008|Loures, Lisboa, Portugal, 2674-514|Bratislava, Slovakia, 833 10 Uroexam, Spol. S R.O.Nitra, Slovakia, 949 01 Poko Poprad S.R.O.Poprad, Slovakia, 085 01|CÃ³rdoba, AndalucÃ­a, Spain, 14004|Badalona, Barcelona, Spain, 08916 Institut CatalÃ  D'Oncologia HospitaletL'Hospitalet De Llobregat, Barcelona, Spain, 08907|Barcelona, Catalunya, Spain, 08003|Barcelona, Spain, 08035 Hospital San Pedro De AlcÃ¡ntaraCÃ¡ceres, Spain, 10003 Md Anderson International Espanya, S.A.Madrid, Spain, 28033 Hospital RamÃ³n Y CajalMadrid, Spain, 28034 Hospital Universitario 12 De OctubreMadrid, Spain, 28041 Hospital Virgen De La VictoriaMÃ¡laga, Spain, 29010 Instituto Valenciano De OncologÃ­aValencia, Spain, 46009 Hospital General Universitario De ValenciaValencia, Spain, 46014|Palma De Mallorca, Illes Baleares, Spain, 07120|Stockholm, Sweden, 118 83 Karolinska InstitutetStockholm, Sweden, 17167 Norrlands Universitetssjukhus, UmeÃ¥UmeÃ¥, Sweden, 901 85|Basel, Basel-Stadt, Switzerland, 4031|Chur, GraubÃ¼nden, Switzerland, 7000|Bern, Switzerland, 3010 Taiwan|St. Gallen, Sankt Gallen, Switzerland, 9007|Bebington, Merseyside, United Kingdom, Ch63 4Jy|Taunton, Somerset, United Kingdom, Ta1 5Da|London, United Kingdom, Sw3 6Jj|Anchorage, Alaska, United States, 99503|Phoenix, Arizona, United States, 85004 University Of Arizona Cancer CenterTucson, Arizona, United States, 85724|Sacramento, California, United States, 95817 Sansum ClinicSanta Barbara, California, United States, 93105|Orlando, Florida, United States, 32806|Chicago, Illinois, United States, 60611|Las Vegas, Nevada, United States, 89169|New York, New York, United States, 10016 Memorial Sloan-Kettering Cancer CenterNew York, New York, United States, 10065|Columbus, Ohio, United States, 43219|Oklahoma City, Oklahoma, United States, 73104|Pittsburgh, Pennsylvania, United States, 15232|Greenville, South Carolina, United States, 29607 Carolina Urological Research CenterMyrtle Beach, South Carolina, United States, 29572|Watertown, South Dakota, United States, 57201|Fort Worth, Texas, United States, 76104 Houston Methodist HospitalHouston, Texas, United States, 77030-2707|Seattle, Washington, United States, 98101 Summit Cancer CenterSpokane, Washington, United States, 99216","Alaska|Arizona|California|Florida|Illinois|Nevada|New York|Ohio|Oklahoma|Pennsylvania|South Carolina|South Dakota|Texas|Washington","Australia|Austria|Belgium|Brazil|Canada|China|Czechia|Denmark|Finland|France|Germany|Hungary|Ireland|Israel|Italy|Japan|Netherlands|Poland|Portugal|Slovakia|Spain|Sweden|Switzerland|United Kingdom|United States","New South Wales Mid North Coast Cancer Institute|Queensland Pindara Private Hospital|Victoria Monash Cancer Centre|Landesklinikum Krems|OberÃ¶sterreich Krankenhaus Der Barmherzigen Schwestern Linz|Steiermark Medizinische UniversitÃ¤t Graz|Uz Gent|Rio Grande Do Sul Irmandade Santa Casa De Misericordia De Porto Alegre|Sao Paulo FundaÃ§Ã£o Pio Xii - Hospital De CÃ¢ncer De Barretos|Ontario Juravinski Cancer Centre|Ottawa Hospital-General Campus|Quebec Sir Mortimer B. Davis Jewish General Hospital|Anhui Anhui Provincial Hospital|Beijing Friendship Hospital, Capital Medical University|Fujian Fujian Medical University Union Hospital|Guangdong Sun Yat-Sen University Cancer Center|Hebei The 2Nd Hospital Of Hebei Medical University|Hospital, Sichuan University|Hubei Hubei Cancer Hospital|Hunan Hunan Cancer Hospital|Jiangsu Nj Drum Tower Hospital, The Affil Hos Of Nj Univ Med School|Jiangxi The First Affiliated Hospital Of Nanchang University|Jilin The First Hospital Of Jilin University|Liaoning Liaoning Cancer Hospital And Institute|Medical University Hospital|Shaanxi 1St Affiliated Hospital Of Xi'An Jiaotong Medical University|Zhejiang Zhejiang Provincial People's Hospital|Fakultni Nemocnice Olomouc|Aarhus Universitetshospital, Skejby|Docrates Klinikka|Hopital J. Minjoz - BesanÃ§on|Baden-WÃ¼rttemberg UniversitÃ¤tsklinikum Freiburg|Bayern UniversitÃ¤tsklinikum Erlangen|Nordrhein-Westfalen Heinrich-Heine-UniversitÃ¤t|Rheinland-Pfalz UniversitÃ¤tsmedizin Der Johannes Gutenberg UniversitÃ¤t Mainz|Sachsen Medizinische FakultÃ¤t Carl Gustav Carus|Vivantes Klinikum Am Urban|Mh Egeszsegugyi Kozpont|Cork University Hospital|Rambam Health Corporation|Emilia-Romagna Irst Istituto Scientifico Romagnolo Per Studio E Cura Tumori|Lazio Policlinico Universitario Campus Biomedico|Lombardia Fondazione Irccs Istituto Nazionale Dei Tumori|Piemonte A.O.U. San Luigi Gonzaga|Puglia Irccs Ist.Tumori Giovanni Paolo Ii - Osp. Oncologico Bari|Toscana A.O.U. Pisana|Veneto A.O.U. Integrata Verona|Aichi Nagoya University Hospital|Akita University Hospital|Aomori Hirosaki University Hospital|Ehime National Hospital Organization Shikoku Cancer Center|Gunma Gunma University Hospital|Hokkaido Sapporo Medical University Hospital|Hyogo Kobe City Medical Center General Hospital|Ibaraki University Of Tsukuba Hospital|Iwate Iwate Medical University Hospital|Kanagawa Yokohama City University Hospital|Osaka Kindai University Hospital|Saitama Saitama Medical University International Medical Center|Tokyo Nippon Medical School Hospital|Nederlands Kanker Instituut|Centrum Onkologii Im. Prof. Franciszka Lukaszczyka|Centro Hospitalar E UniversitÃ¡rio De Coimbra|Lisboa Hospital Beatriz Angelo|Narodny Onkologicky Ustav|AndalucÃ­a Hospital Reina SofÃ­a|Barcelona Institut CatalÃ  D'Oncologia Badalona|Catalunya Hospital Del Mar|Ciutat SanitÃ ria I Universitaria De La Vall D'Hebron|Illes Baleares Hospital Universitari Son Espases|SÃ¶dersjukhuset|Basel-Stadt UniversitÃ¤tsspital Basel|GraubÃ¼nden Kantonsspital GraubÃ¼nden|Inselspital UniversitÃ¤tsspital Bern|Sankt Gallen Kantonsspital St. Gallen|, Merseyside Clatterbridge Centre For Oncology|, Somerset Musgrove Park Hospital|The Royal Marsden Hospital|Alaska Clinical Research Center, Llc|Univeristy Of Arizona Cancer Center|Uc Davis Comprehensive Cancer Center|Uf Cancer Center At Orlando Health|Northwestern Medical Faculty Foundation Div Of Hem/Oncology|Comprehensive Cancer Centers Of Nevada|Nyu Langone Medical Center|Mid Ohio Oncology/Hematology Inc.|Oklahoma University Health Science Center|University Of Pittsburgh|Bon Secours St. Francis Hospital|Prairie Lakes Cancer Center|The Center For Cancer And Blood Disorders|Virginia Mason Medical Center",{"$nulls":3},"Bayer Study Director","2018-07-09","2020-05-25T16:38:39.990","2020-05-26T17:10:42.972","NCT03410693"]
["5ecbf490fe30261b1a048348","NCT03410693","2018-10-17","Bayer","BAYN","Recruiting","Study of Rogaratinib (BAY1163877) vs Chemotherapy in Patients With FGFR (Fibroblast Growth Factor Receptor)-Positive Locally Advanced or Metastatic Urothelial Carcinoma (FORT-1)","Bay-1163877",null,"Yes","['Bay-1163877']","Unknown",null,"Phase 2/Phase 3",2,400,"Anticipated","2018-05-31","2022-04-25","OS","Overall Survival",{"$nulls":3},"This is a randomized, open-label, multicenter Phase 2/3 study to evaluate the efficacy and safety of rogaratinib (BAY 1163877) compared to chemotherapy in patients with FGFRpositive locally advanced or metastatic urothelial carcinoma who have received Prior platinum-containing chemotherapy.\n\nThe primary objective of the entire study is to compare rogaratinib (BAY1163877) with chemotherapy (docetaxel, paclitaxel or vinflunine) in terms of prolonging the Overall survival (OS) of patients with FGFR positive urothelial carcinoma.\n\nAt randomization, patients will have locally advanced or metastatic urothelial carcinoma and have received at least one prior platinum-containing chemotherapy regimen. Only patients with FGFR1 or 3 positive tumors can be randomized into the study. Archival tumor tissue is adequate for testing of FGFR1 and 3 mRNA expressions, which will be determined centrally using an RNA in situ hybridization (RNA-ISH) test. Approximately 42 % of UC patients with locally advanced or metastatic UC are identified as FGFR-positive by the RNA-ISH cut-off applied.",null,"A Randomized, Open Label, Multicenter Phase 2/3 Study to Evaluate the Efficacy and Safety of Rogaratinib (BAY1163877) Compared to Chemotherapy in Patients With FGFR-positive Locally Advanced or Metastatic Urothelial Carcinoma Who Have Received Prior Platinum-containing Chemotherapy",17403,"Carcinoma, Transitional Cell","Noma|Carcinoma|Transitional Cell Carcinoma","Mouth Diseases|Oncology Solid Tumor","Ear, Nose and Throat|Oncology","Experimental|Active Comparator","Rogaratinib|Chemotherapy",null,"Drug","Rogaratinib (BAY1163877)|Chemotherapy","Rogaratinib administered as oral (p.o.) tablets twice daily (b.i.d.) continuously|Chemotherapy as taxane (docetaxel or paclitaxel) or vinflunine administered through intravenous (i.v.) infusion every 3 weeks (on day 1 of a 21-day cycle) The choice of the chemotherapy is at the discretion of the investigator, taking into consideration the status of the authorization in the given Country (i.e. the drug has to be approved at least for one indication in the given country).",null,"Rogaratinib|Chemotherapy","\n\n * Existence of archival or fresh biopsy for FGFR testing\n * FGFR testing of patients will be performed at the investigators' discretion up to a max. of 90 days prior to start of screening.\n\nInvestigators should ensure all patients will be eligible in terms of disease status and lines of treatment within this timeframe.\n\n * Documented urothelial carcinoma (transitional cell carcinoma) including urinary bladder, renal pelvis, ureters, urethra meeting all of the following criteria * Histologically or cytologically confirmed (patients with mixed histologies are required to have a dominant transitional cell pattern.)\n    * Locally advanced (T4b, any N; or any T, N 2âˆ’3) or metastatic disease (any T, any N and M1). Locally advanced bladder cancer must be unresectable i.e. invading the pelvic or abdominal wall (stage T4b) or presenting with bulky nodal disease (N2-3).\n   \n   \n * ECOG (Eastern Cooperative Oncology Group) Performance Status of 0 or 1\n * Disease progression during or following treatment with at least one platinum-containing regimen (patients should have been treated for at least 2 cycles). In patients who received prior adjuvant/ neoadjuvant platinum-containing chemotherapy, progression had to occur within 12 months of treatment.\n * High FGFR1 or 3 mRNA (Messenger ribonucleic acid) expression levels (RNAscope score of 3+ or 4+; measurement is part of this protocol) in archival or fresh Tumor biopsy specimen\n * At least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST v.1.1) in contrast enhanced (unless contraindicated) CT or MRI\n\n","\n\n * Previous or concurrent cancer except * cervical carcinoma in situ\n    * treated basal-cell or squamous cell skin carcinoma\n    * any cancer curatively treated > 3 years before randomization\n    * curatively treated incidental prostate cancer (T1/T2a)\n   \n   \n * Ongoing or previous anti-cancer treatment within 4 weeks before randomization.\n * More than two prior lines of systemic anti-cancer therapy for urothelial carcinoma\n * Ongoing or previous treatment with anti-FGFR directed therapies (e.g. receptor tyrosine kinase inhibitors including rogaratinib or FGFRspecific antibodies) or with taxanes or vinflunine\n * Unresolved toxicity higher than National Cancer Institute's Common Terminology Criteria for Adverse Events, version 4.03 (CTCAE v.4.03) Grade 1 attributed to any prior therapy/ procedure excluding alopecia, anemia and/ or hypothyroidism\n * History or current condition of an uncontrolled cardiovascular disease including any of the following conditions: * Congestive heart failure (CHF) NYHA (New York Heart Association) > Class 2\n    * Unstable angina (symptoms of angina at rest) or new-onset angina (within last 3 months before randomization)\n    * Myocardial infarction (MI) within past 6 months before randomization\n    * Unstable cardiac arrhythmias requiring anti-arrhythmic therapy. Patients with arrhythmia under control with anti-arrhythmic therapy such as beta-blockers or digoxin are eligible.\n   \n   \n * Arterial or venous thrombotic events or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within 3 months before randomization\n * Current evidence of endocrine alteration of calcium phosphate homeostasis (e.g. parathyroid disorder, history of parathyroidectomy, tumor lysis, tumoral calcinosis, paraneoplastic hypercalcemia)\n * Any hemorrhage / bleeding event â‰¥ CTCAE v.4.03 Grade 3 within 4 weeks before randomization\n * Current diagnosis of any retinal detachment, retinal pigment epithelial detachment (RPED), serous retinopathy or retinal vein occlusion",{"$nulls":4},"Actual","2018-01-25","Actual","Anticipated","2022-04-25","Anticipated","2018-10-01","2018-01-19","2018-01-19","2018-10-16","Yes","Urothelial carcinoma","Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"2016-004340-11","EudraCT Number","Overall Survival","Defined as the time (days) from randomization to death due to any cause. Patients alive at the date of data cut-off for analysis will be censored at the last date known to be alive.","Up to 45 months","Progression-free survival (PFS)|Objective response rate (ORR)|Disease-control rate (DCR)|Duration of response (DOR)|Incidence of Adverse Events as a measure of safety and tolerability","Defined as the time (days) from randomization to date of first observed disease progression (radiological or clinical assessment) or death due to any cause, if death occurs before progression is documented. For patients without documented radiological or clinical progression or death at the time of analysis, PFS will be censored at the last actual visit date of tumor evaluation.|Defined as the percentage of patients with complete response (CR) or partial Response (PR). Patients for whom overall best response is not CR or PR, as well as patients without any post-baseline tumor assessment will be considered non-responders.|Defined as the percentage of patients, whose overall best response was not progressive disease|Defined as the time from the first documented objective response of PR or CR, whichever is noted earlier, to disease progression or death (if death occurs before progression is documented). DOR will be defined for responders only, i.e. patients with a CR or PR.|Up to 45 months","Up to 45 months|PD (i.e. CR, PR, Stable Disease","clinical-trials-contact@bayer.com","Bayer Clinical Trials Contact","(+) 1-888-8422937","Coffs Harbour, New South Wales, Australia, 2450 Northern Cancer InstituteSt Leonards, New South Wales, Australia, 2065 Macquarie University HospitalSydney, New South Wales, Australia, 2109 Riverina Cancer Care CentreWagga Wagga, New South Wales, Australia, 2650 Sydney Adventist HospitalWahroonga, New South Wales, Australia, 2076|Benowa, Queensland, Australia, 4217|Clayton, Victoria, Australia, 3168|Krems, Austria, 3500 Krankenhaus Der Barmherzigen BrÃ¼derWien, Austria, 1020 Allgemeines Krankenhaus Der Stadt WienWien, Austria, 1090 Wilhelminenspital Der Stadt WienWien, Austria, 1160|Linz, OberÃ¶sterreich, Austria, 4010|Graz, Steiermark, Austria, 8036|Gent, Belgium, 9000 Ch De Jolimont - Lobbes Site De JolimontLa Louviere, Belgium, 7100 Uz Leuven GasthuisbergLeuven, Belgium, 3000 Chu De LiÃ¨geLiege, Belgium, 4000 Clinique Saint-PierreOttignies, Belgium, 1340|Porto Alegre, Rio Grande Do Sul, Brazil, 90050 170|Barretos, Sao Paulo, Brazil, 14784400 Hosp ClÃ­nicas Facult. Med. De RibeirÃ£o Preto / UspRibeirÃ£o Preto, Sao Paulo, Brazil, 14048-900 Hospital De Base Da FundaÃ§Ã£o F M S J Rio PretoSÃ£o JosÃ© Do Rio Preto, Sao Paulo, Brazil|Hamilton, Ontario, Canada, L8V 5C2 London Regional Cancer ProgramLondon, Ontario, Canada, N6A 4L6 Princess Margaret Hospital-University Health NetworkToronto, Ontario, Canada, M5G 2M9|Ottawa, Canada, K1H 8L6|Montreal, Quebec, Canada, H3T 1E2|Hefei, Anhui, China, 230001|Beijing, China, 100050 The 307Th Hospital Of Chinese People'S Liberation ArmyBeijing, China, 100071 Peking University Third HospitalBeijing, China, 100191 Beijing HospitalBeijing, China, 100730 Peking Union Medical College Hospital CamsBeijing, China, 100730 Chongqing Cancer HospitalChongqing, China, 400030 First Affiliated Hospital Of Guangzhou Medical UniversityGuangzhou, China Fudan University Shanghai Cancer CenterShanghai, China, 200032 Zhongshan Hospital, Fudan UniversityShanghai, China, 200032 Huadong Hospital, Affiliated To Fudan UniversityShanghai, China, 200040 Tianjin Medical University Cancer Institiute & HospitalTianjin, China, 300060|Fuzhou, Fujian, China, 350001 The First Affiliated Hospital Of Xiamen UniversityXiamen, Fujian, China, 361003|Guangzhou, Guangdong, China, 510060|Shijiazhuang, Hebei, China, 050000|Chengdu, Sichuan, China, 610041 The First Hospital To AmuChongqing, Sichuan, China, 400038|Wuhan, Hubei, China, 430079|Changsha, Hunan, China, 410013|Nanjing, Jiangsu, China, 210008 Jiangsu Cancer HospitalNanjing, Jiangsu, China, 210009|Nanchang, Jiangxi, China, 330006|Changchun, Jilin, China, 130021|Shengyang, Liaoning, China, 110042|Taichung, Taiwan, 40447 Taichung Veterans General HospitalTaichung, Taiwan, 40705 National Cheng Kung University HospitalTainan, Taiwan National Taiwan University HospitalTaipei, Taiwan, 10002 Taipei Veterans General HospitalTaipei, Taiwan, 11217 Chang Gung Memorial Hospital At LinkouTaoyuan, Taiwan, 333|Xi'An, Shaanxi, China, 710061|Hangzhou, Zhejiang, China, 310014 The First Affiliated Hospital Of Wenzhou Medical UniversityWenzhou, Zhejiang, China, 325000|Olomouc, Czechia, 775 20 Fakultni Nemocnice OstravaOstrava, Czechia, 708 52 Fakultni Nemocnice Kralovske VinohradyPraha 10, Czechia, 10034 Fakultni Thomayerova NemocnicePraha 4 - Krc, Czechia, 140 59 Bata HospitalZlin, Czechia, 762 75|Aarhus N, Denmark, 8200 Herlev HospitalHerlev, Denmark, 2730 H:S RigshospitaletKÃ¸benhavn, Denmark, 2100|Helsinki, Finland, 00180 Tampereen Yliopistollinen Sairaala, KeskussairaalaTampere, Finland, Fin-33520|Besancon, France, 25030 HÃ´pital Saint AndrÃ© - BordeauxBordeaux, France, 33000 Centre De Lutte Contre Le Cancer FranÃ§ois BaclesseCaen Cedex 5, France, 14076 Centre Jean PerrinClermont Ferrand Cedex 1, France, 63011 Centre Oscar Lambret - LilleLille Cedex, France, 59020 Centre LÃ©on BÃ©rardLyon Cedex, France, 69008 Institut Paoli-Calmettes - MarseilleMarseille, France, 13273 HÃ´pital Saint LouisParis, France, 75010 Cochin - ParisParis, France, 75674 HÃ´pital D'Instruction Des ArmÃ©es BeginSaint Mande, France, 94160 Clinique Saint AnneStrasbourg, France, 67000 Centre MÃ©dico-Chirurgical FochSuresnes, France, 92151|Freiburg, Baden-WÃ¼rttemberg, Germany, 79106 Klinikum Der Eberhard-Karls-UniversitÃ¤t TÃ¼bingenTÃ¼bingen, Baden-WÃ¼rttemberg, Germany, 72076 UniversitÃ¤tsklinikum UlmUlm, Baden-WÃ¼rttemberg, Germany, 89075|Erlangen, Bayern, Germany, 91054|DÃ¼sseldorf, Nordrhein-Westfalen, Germany, 40225 UniversitÃ¤tsklinikum KÃ¶lnKÃ¶ln, Nordrhein-Westfalen, Germany, 50937|Mainz, Rheinland-Pfalz, Germany, 55131|Dresden, Sachsen, Germany, 01307|Berlin, Germany, 10967 Medizinische FakultÃ¤t Der Otto-Von-Guericke UniversitÃ¤tMagdeburg, Germany, 39120 Hong Kong Queen Mary HospitalHong Kong, Hong Kong Princess Margaret HospitalKowloon, Hong Kong Queen Elizabeth HospitalKowloon, Hong Kong Prince Of Wales HospitalShatin, Hong Kong|Budapest, Hungary, 1062 Semmelweis EgyetemBudapest, Hungary, 1082 Bajcsy Zsilinszky Korhaz-RendelointezetBudapest, Hungary, 1106 Orszagos Onkologiai IntezetBudapest, Hungary, 1122 Debreceni Egyetem Klinikai KozpontDebrecen, Hungary, 4032 Pecsi Tudomanyegyetem Klinikai KozpontPecs, Hungary, 7624|Cork, Ireland AmnchDublin, Ireland, 24 Mater Misericordiae University HospitalDublin, Ireland, 7 Mater Private HospitalDublin, Ireland, 7|Haifa, Israel, 3109601 Hadassah Hebrew University Hospital Ein KeremJerusalem, Israel, 9112001 Meir Medical CenterKfar Saba, Israel, 4428164 Rabin Medical Center - Beilinson CampusPetah Tikva, Israel, 4941492 Chaim Sheba Medical CenterRamat Gan, Israel, 5266202|ForlÃ¬-Cesena, Emilia-Romagna, Italy, 47014 Ausl ModenaModena, Emilia-Romagna, Italy, 41012 A.O.U. Di Modena - PoliclinicoModena, Emilia-Romagna, Italy, 41124|Roma, Lazio, Italy, 00128 A.O. San Camillo-ForlaniniRoma, Lazio, Italy, 00152 Fondazione Policlinico Universitario Agostino GemelliRoma, Lazio, Italy, 00168|Milano, Lombardia, Italy, 20133 Irccs Istituto Europeo Di OncologiaMilano, Lombardia, Italy, 20141 Asst Grande Ospedale Metropolitano NiguardaMilano, Lombardia, Italy, 20162|Torino, Piemonte, Italy, 10043|Bari, Puglia, Italy, 70124|Pisa, Toscana, Italy, 56126|Verona, Veneto, Italy, 37134|Nagoya, Aichi, Japan, 466-8560|Akita, Japan, 010-8543 Kyushu University HospitalFukuoka, Japan, 812-8582 Hiroshima City Hiroshima Citizens HospitalHiroshima, Japan, 730-8518 Kumamoto University HospitalKumamoto, Japan, 860-8556 Niigata University Medical And Dental HospitalNiigata, Japan, 951-8520 Osaka International Cancer InstituteOsaka, Japan, 541-8567 Tokushima University HospitalTokushima, Japan, 770-8503 Toyama University HospitalToyama, Japan, 930-0194 Korea, Republic Of, Gyeonggido National Cancer CenterGoyang-Si, Gyeonggido, Korea, Republic Of, 410-769 Korea, Republic Of Asan Medical CenterSeoul, Korea, Republic Of, 05505 Samsung Medical CenterSeoul, Korea, Republic Of, 06351 Yonsei University College Of MedicineSeoul, Korea, Republic Of, 120-752|Hirosaki, Aomori, Japan, 036-8563|Matsuyama, Ehime, Japan, 791-0280|Maebashi, Gunma, Japan, 371-8511 Gunma Prefectural Cancer CenterOta, Gunma, Japan, 373-8550|Sapporo, Hokkaido, Japan, 060-8543 Hokkaido University HospitalSapporo, Hokkaido, Japan, 060-8648|Kobe, Hyogo, Japan, 650-0047|Tsukuba, Ibaraki, Japan, 305-8576|Morioka, Iwate, Japan, 020-8505|Yokohama, Kanagawa, Japan, 236-0004|Osakasayama, Osaka, Japan, 589-8511|Hidaka, Saitama, Japan, 350-1298|Bunkyo-Ku, Tokyo, Japan, 113-8603 National Cancer Center HospitalChuo-Ku, Tokyo, Japan, 104-0045 The Cancer Institute Hospital Of JfcrKoto-Ku, Tokyo, Japan, 135-8550 Keio University HospitalShinjuku-Ku, Tokyo, Japan, 160-8582|Amsterdam, Netherlands, 1066 Cx Universitair Medisch Centrum St. RadboudNijmegen, Netherlands, 6525 Ga Erasmus Medisch CentrumRotterdam, Netherlands, 3075 Ea|Bydgoszcz, Poland, 85-796 Swietokrzyskie Centrum OnkologiiKielce, Poland, 25-734 Przychodnia Lekarska KomedKonin, Poland, 62-500 Salve Medica Sp. Z O.O. Sp.K.Lodz, Poland, 91-211 Samodzielny Publiczny Zespol Gruzlicy I Chorob PlucOlsztyn, Poland, 10-357 Sp Szpital Kliniczny Nr 2Poznan, Poland, 60-569 Uroprojekt S.C. - Gabinet UrologicznySiedlce, Poland, 08-110 Centralny Szpital Kliniczny Mswia W WarszawieWarszawa, Poland, 02-507 Uniwersytecki Szpital Kliniczny Im. J. Mikulicza-RadeckiegoWroclaw, Poland, 50-556|Coimbra, Portugal, 3000-075 Instituto PortuguÃªs De Oncologia Francisco Gentil - CoimbraCoimbra, Portugal, 3000-075 Hospital Cuf Infante SantoLisboa, Portugal, 1350-070 Centro Hospitalar De Lisboa Norte - Hospital Santa MariaLisboa, Portugal, 1649-035 Centro Hospitalar Do Porto, Epe - Hospital De Santo AntonioPorto, Portugal, 4099-001 Russian Federation Krasnoyarsk Regional Clinical Oncology DispensaryKrasnoyarsk, Russian Federation, 660133 Moscow Scient. Res. Institute Of Oncology N.A P.A. HertzenMoscow, Russian Federation, 125284 Urological Center PomcNizhny Novgorod, Russian Federation, 603109 Medical Center \"Avicenna\"Novosibirsk, Russian Federation, 630099 Clinical Oncological Dispensary Of Omsk RegionOmsk, Russian Federation, 644013 Samara Regional Clinical Oncology DispensarySamara, Russian Federation, 443031 Bashkir State Medical UniversityUfa, Russian Federation, 450008|Loures, Lisboa, Portugal, 2674-514|Bratislava, Slovakia, 833 10 Uroexam, Spol. S R.O.Nitra, Slovakia, 949 01 Poko Poprad S.R.O.Poprad, Slovakia, 085 01|CÃ³rdoba, AndalucÃ­a, Spain, 14004|Badalona, Barcelona, Spain, 08916 Institut CatalÃ  D'Oncologia HospitaletL'Hospitalet De Llobregat, Barcelona, Spain, 08907|Barcelona, Catalunya, Spain, 08003|Barcelona, Spain, 08035 Hospital San Pedro De AlcÃ¡ntaraCÃ¡ceres, Spain, 10003 Md Anderson International Espanya, S.A.Madrid, Spain, 28033 Hospital RamÃ³n Y CajalMadrid, Spain, 28034 Hospital Universitario 12 De OctubreMadrid, Spain, 28041 Hospital Virgen De La VictoriaMÃ¡laga, Spain, 29010 Instituto Valenciano De OncologÃ­aValencia, Spain, 46009 Hospital General Universitario De ValenciaValencia, Spain, 46014|Palma De Mallorca, Illes Baleares, Spain, 07120|Stockholm, Sweden, 118 83 Karolinska InstitutetStockholm, Sweden, 17167 Norrlands Universitetssjukhus, UmeÃ¥UmeÃ¥, Sweden, 901 85|Basel, Basel-Stadt, Switzerland, 4031|Chur, GraubÃ¼nden, Switzerland, 7000|Bern, Switzerland, 3010 Taiwan|St. Gallen, Sankt Gallen, Switzerland, 9007|Bebington, Merseyside, United Kingdom, Ch63 4Jy|Taunton, Somerset, United Kingdom, Ta1 5Da|London, United Kingdom, Sw3 6Jj|Anchorage, Alaska, United States, 99503|Phoenix, Arizona, United States, 85004 University Of Arizona Cancer CenterTucson, Arizona, United States, 85724|Sacramento, California, United States, 95817 Sansum ClinicSanta Barbara, California, United States, 93105|Littleton, Colorado, United States, 80120-4413|New Haven, Connecticut, United States, 06510|Orlando, Florida, United States, 32806|Chicago, Illinois, United States, 60611|Westwood, Kansas, United States, 66205|New Orleans, Louisiana, United States, 70112|Las Vegas, Nevada, United States, 89169|New York, New York, United States, 10016 Memorial Sloan-Kettering Cancer CenterNew York, New York, United States, 10065|Oklahoma City, Oklahoma, United States, 73104|Tualatin, Oregon, United States, 97062|Pittsburgh, Pennsylvania, United States, 15232|Greenville, South Carolina, United States, 29607 Carolina Urological Research CenterMyrtle Beach, South Carolina, United States, 29572|Watertown, South Dakota, United States, 57201|Denton, Texas, United States, 76210 The Center For Cancer And Blood DisordersFort Worth, Texas, United States, 76104 Houston Methodist HospitalHouston, Texas, United States, 77030-2707|Salt Lake City, Utah, United States, 84103|Seattle, Washington, United States, 98101 Summit Cancer CenterSpokane, Washington, United States, 99208","Alaska|Arizona|California|Colorado|Connecticut|Florida|Illinois|Kansas|Louisiana|Nevada|New York|Oklahoma|Oregon|Pennsylvania|South Carolina|South Dakota|Texas|Utah|Washington","Australia|Austria|Belgium|Brazil|Canada|China|Czechia|Denmark|Finland|France|Germany|Hungary|Ireland|Israel|Italy|Japan|Netherlands|Poland|Portugal|Slovakia|Spain|Sweden|Switzerland|United Kingdom|United States","New South Wales Mid North Coast Cancer Institute|Queensland Pindara Private Hospital|Victoria Monash Medical Centre|Landesklinikum Krems|OberÃ¶sterreich Krankenhaus Der Barmherzigen Schwestern Linz|Steiermark Medizinische UniversitÃ¤t Graz|Uz Gent|Rio Grande Do Sul Irmandade Santa Casa De Misericordia De Porto Alegre|Sao Paulo FundaÃ§Ã£o Pio Xii - Hospital De CÃ¢ncer De Barretos|Ontario Juravinski Cancer Centre|Ottawa Hospital-General Campus|Quebec Sir Mortimer B. Davis Jewish General Hospital|Anhui Anhui Provincial Hospital|Beijing Friendship Hospital, Capital Medical University|Fujian Fujian Medical University Union Hospital|Guangdong Sun Yat-Sen University Cancer Center|Hebei The 2Nd Hospital Of Hebei Medical University|Hospital, Sichuan University|Hubei Hubei Cancer Hospital|Hunan Hunan Cancer Hospital|Jiangsu Nj Drum Tower Hospital, The Affil Hos Of Nj Univ Med School|Jiangxi The First Affiliated Hospital Of Nanchang University|Jilin The First Hospital Of Jilin University|Liaoning Liaoning Cancer Hospital And Institute|Medical University Hospital|Shaanxi 1St Affiliated Hospital Of Xi'An Jiaotong Medical University|Zhejiang Zhejiang Provincial People's Hospital|Fakultni Nemocnice Olomouc|Aarhus Universitetshospital, Skejby|Docrates Klinikka|Hopital Jean Minjoz|Baden-WÃ¼rttemberg UniversitÃ¤tsklinikum Freiburg|Bayern UniversitÃ¤tsklinikum Erlangen|Nordrhein-Westfalen Heinrich-Heine-UniversitÃ¤t|Rheinland-Pfalz UniversitÃ¤tsmedizin Der Johannes Gutenberg UniversitÃ¤t Mainz|Sachsen Medizinische FakultÃ¤t Carl Gustav Carus|Vivantes Klinikum Am Urban|Mh Egeszsegugyi Kozpont|Cork University Hospital|Rambam Health Corporation|Emilia-Romagna Irst Istituto Scientifico Romagnolo Per Studio E Cura Tumori|Lazio Policlinico Universitario Campus Biomedico|Lombardia Fondazione Irccs Istituto Nazionale Dei Tumori|Piemonte A.O.U. San Luigi Gonzaga|Puglia Irccs Ist.Tumori Giovanni Paolo Ii - Osp. Oncologico Bari|Toscana A.O.U. Pisana|Veneto A.O.U. Integrata Verona|Aichi Nagoya University Hospital|Akita University Hospital|Aomori Hirosaki University Hospital|Ehime National Hospital Organization Shikoku Cancer Center|Gunma Gunma University Hospital|Hokkaido Sapporo Medical University Hospital|Hyogo Kobe City Medical Center General Hospital|Ibaraki University Of Tsukuba Hospital|Iwate Iwate Medical University Hospital|Kanagawa Yokohama City University Hospital|Osaka Kindai University Hospital|Saitama Saitama Medical University International Medical Center|Tokyo Nippon Medical School Hospital|Nederlands Kanker Instituut|Centrum Onkologii Im. Prof. Franciszka Lukaszczyka|Chuc - Hospitais Da Universidade De Coimbra|Lisboa Hospital Beatriz Angelo|Narodny Onkologicky Ustav|AndalucÃ­a Hospital Reina SofÃ­a|Barcelona Institut CatalÃ  D'Oncologia Badalona|Catalunya Hospital Del Mar|Ciutat SanitÃ ria I Universitaria De La Vall D'Hebron|Illes Baleares Hospital Universitari Son Espases|SÃ¶dersjukhuset|Basel-Stadt UniversitÃ¤tsspital Basel|GraubÃ¼nden Kantonsspital GraubÃ¼nden|Inselspital UniversitÃ¤tsspital Bern|Sankt Gallen Kantonsspital St. Gallen|, Merseyside Clatterbridge Centre For Oncology|, Somerset Musgrove Park Hospital|The Royal Marsden Hospital|Alaska Clinical Research Center, Llc|Univeristy Of Arizona Cancer Center|Uc Davis Comprehensive Cancer Center|Rocky Mountain Cancer Centers|Yale Cancer Center|Uf Cancer Center At Orlando Health|Northwestern Medical Faculty Foundation Div Of Hem/Oncology|University Of Kansas Medical Center|Louisiana State University|Comprehensive Cancer Centers Of Nevada|Nyu Langone Medical Center|Oklahoma University Health Science Center|Compass Oncology|University Of Pittsburgh|Bon Secours St. Francis Hospital|Prairie Lakes Cancer Center|Texas Oncology-Denton South|Huntsman Cancer Institute- University Of Utah|Virginia Mason Medical Center",{"$nulls":3},"Bayer Study Director","2018-10-16","2020-05-25T16:38:40.956","2020-05-26T17:10:42.972","NCT03410693"]
["5ecbf49111702c1b1b916b55","NCT03410693","2018-12-19","Bayer","BAYN","Recruiting","Study of Rogaratinib (BAY1163877) vs Chemotherapy in Patients With FGFR (Fibroblast Growth Factor Receptor)-Positive Locally Advanced or Metastatic Urothelial Carcinoma (FORT-1)","Bay-1163877",null,"Yes","['Bay-1163877']","Unknown",null,"Phase 2/Phase 3",2,400,"Anticipated","2018-05-31","2022-04-25","OS","Overall Survival",{"$nulls":3},"This is a randomized, open-label, multicenter Phase 2/3 study to evaluate the efficacy and safety of rogaratinib (BAY 1163877) compared to chemotherapy in patients with FGFRpositive locally advanced or metastatic urothelial carcinoma who have received Prior platinum-containing chemotherapy.\n\nThe primary objective of the entire study is to compare rogaratinib (BAY1163877) with chemotherapy (docetaxel, paclitaxel or vinflunine) in terms of prolonging the Overall survival (OS) of patients with FGFR positive urothelial carcinoma.\n\nAt randomization, patients will have locally advanced or metastatic urothelial carcinoma and have received at least one prior platinum-containing chemotherapy regimen. Only patients with FGFR1 or 3 positive tumors can be randomized into the study. Archival tumor tissue is adequate for testing of FGFR1 and 3 mRNA expressions, which will be determined centrally using an RNA in situ hybridization (RNA-ISH) test. Approximately 42 % of UC patients with locally advanced or metastatic UC are identified as FGFR-positive by the RNA-ISH cut-off applied.",null,"A Randomized, Open Label, Multicenter Phase 2/3 Study to Evaluate the Efficacy and Safety of Rogaratinib (BAY1163877) Compared to Chemotherapy in Patients With FGFR-positive Locally Advanced or Metastatic Urothelial Carcinoma Who Have Received Prior Platinum-containing Chemotherapy",17403,"Carcinoma, Transitional Cell","Noma|Carcinoma|Transitional Cell Carcinoma","Mouth Diseases|Oncology Solid Tumor","Ear, Nose and Throat|Oncology","Experimental|Active Comparator","Rogaratinib|Chemotherapy",null,"Drug","Rogaratinib (BAY1163877)|Chemotherapy","Rogaratinib administered as oral (p.o.) tablets twice daily (b.i.d.) continuously|Chemotherapy as taxane (docetaxel or paclitaxel) or vinflunine administered through intravenous (i.v.) infusion every 3 weeks (on day 1 of a 21-day cycle) The choice of the chemotherapy is at the discretion of the investigator, taking into consideration the status of the authorization in the given Country (i.e. the drug has to be approved at least for one indication in the given country).",null,"Rogaratinib|Chemotherapy","\n\n * Existence of archival or fresh biopsy for FGFR testing\n * FGFR testing of patients will be performed at the investigators' discretion up to a max. of 90 days prior to start of screening.\n\nInvestigators should ensure all patients will be eligible in terms of disease status and lines of treatment within this timeframe.\n\n * Documented urothelial carcinoma (transitional cell carcinoma) including urinary bladder, renal pelvis, ureters, urethra meeting all of the following criteria * Histologically or cytologically confirmed (patients with mixed histologies are required to have a dominant transitional cell pattern.)\n    * Locally advanced (T4b, any N; or any T, N 2âˆ’3) or metastatic disease (any T, any N and M1). Locally advanced bladder cancer must be unresectable i.e. invading the pelvic or abdominal wall (stage T4b) or presenting with bulky nodal disease (N2-3).\n   \n   \n * ECOG (Eastern Cooperative Oncology Group) Performance Status of 0 or 1\n * Disease progression during or following treatment with at least one platinum-containing regimen (patients should have been treated for at least 2 cycles). In patients who received prior adjuvant/ neoadjuvant platinum-containing chemotherapy, progression had to occur within 12 months of treatment.\n * High FGFR1 or 3 mRNA (Messenger ribonucleic acid) expression levels (RNAscope score of 3+ or 4+; measurement is part of this protocol) in archival or fresh Tumor biopsy specimen\n * At least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST v.1.1) in contrast enhanced (unless contraindicated) CT or MRI\n\n","\n\n * Previous or concurrent cancer except * cervical carcinoma in situ\n    * treated basal-cell or squamous cell skin carcinoma\n    * any cancer curatively treated > 3 years before randomization\n    * curatively treated incidental prostate cancer (T1/T2a)\n   \n   \n * Ongoing or previous anti-cancer treatment within 4 weeks before randomization.\n * More than two prior lines of systemic anti-cancer therapy for urothelial carcinoma\n * Ongoing or previous treatment with anti-FGFR directed therapies (e.g. receptor tyrosine kinase inhibitors including rogaratinib or FGFRspecific antibodies) or with taxanes or vinflunine\n * Unresolved toxicity higher than National Cancer Institute's Common Terminology Criteria for Adverse Events, version 4.03 (CTCAE v.4.03) Grade 1 attributed to any prior therapy/ procedure excluding alopecia, anemia and/ or hypothyroidism\n * History or current condition of an uncontrolled cardiovascular disease including any of the following conditions: * Congestive heart failure (CHF) NYHA (New York Heart Association) > Class 2\n    * Unstable angina (symptoms of angina at rest) or new-onset angina (within last 3 months before randomization)\n    * Myocardial infarction (MI) within past 6 months before randomization\n    * Unstable cardiac arrhythmias requiring anti-arrhythmic therapy. Patients with arrhythmia under control with anti-arrhythmic therapy such as beta-blockers or digoxin are eligible.\n   \n   \n * Arterial or venous thrombotic events or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within 3 months before randomization\n * Current evidence of endocrine alteration of calcium phosphate homeostasis (e.g. parathyroid disorder, history of parathyroidectomy, tumor lysis, tumoral calcinosis, paraneoplastic hypercalcemia)\n * Any hemorrhage / bleeding event â‰¥ CTCAE v.4.03 Grade 3 within 4 weeks before randomization\n * Current diagnosis of any retinal detachment, retinal pigment epithelial detachment (RPED), serous retinopathy or retinal vein occlusion",{"$nulls":4},"Actual","2018-01-25","Actual","Anticipated","2022-04-25","Anticipated","2018-12-01","2018-01-19","2018-01-19","2018-12-17","Yes","Urothelial carcinoma","Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"2016-004340-11","EudraCT Number","Overall Survival","Defined as the time (days) from randomization to death due to any cause. Patients alive at the date of data cut-off for analysis will be censored at the last date known to be alive.","Up to 45 months","Progression-free survival (PFS)|Objective response rate (ORR)|Disease-control rate (DCR)|Duration of response (DOR)|Incidence of Adverse Events as a measure of safety and tolerability","Defined as the time (days) from randomization to date of first observed disease progression (radiological or clinical assessment) or death due to any cause, if death occurs before progression is documented. For patients without documented radiological or clinical progression or death at the time of analysis, PFS will be censored at the last actual visit date of tumor evaluation.|Defined as the percentage of patients with complete response (CR) or partial Response (PR). Patients for whom overall best response is not CR or PR, as well as patients without any post-baseline tumor assessment will be considered non-responders.|Defined as the percentage of patients, whose overall best response was not progressive disease|Defined as the time from the first documented objective response of PR or CR, whichever is noted earlier, to disease progression or death (if death occurs before progression is documented). DOR will be defined for responders only, i.e. patients with a CR or PR.|Up to 45 months","Up to 45 months|PD (i.e. CR, PR, Stable Disease","clinical-trials-contact@bayer.com","Bayer Clinical Trials Contact","(+) 1-888-8422937","Coffs Harbour, New South Wales, Australia, 2450 Northern Cancer InstituteSt Leonards, New South Wales, Australia, 2065 Macquarie University HospitalSydney, New South Wales, Australia, 2109 Riverina Cancer Care CentreWagga Wagga, New South Wales, Australia, 2650 Sydney Adventist HospitalWahroonga, New South Wales, Australia, 2076|Benowa, Queensland, Australia, 4217|Clayton, Victoria, Australia, 3168|Krems, Austria, 3500 Krankenhaus Der Barmherzigen BrÃ¼derWien, Austria, 1020 Allgemeines Krankenhaus Der Stadt WienWien, Austria, 1090 Wilhelminenspital Der Stadt WienWien, Austria, 1160|Linz, OberÃ¶sterreich, Austria, 4010|Graz, Steiermark, Austria, 8036|Gent, Belgium, 9000 Ch De Jolimont - Lobbes Site De JolimontLa Louviere, Belgium, 7100 Uz Leuven GasthuisbergLeuven, Belgium, 3000 Chu De LiÃ¨geLiege, Belgium, 4000 Clinique Saint-PierreOttignies, Belgium, 1340|Porto Alegre, Rio Grande Do Sul, Brazil, 90050 170|Barretos, Sao Paulo, Brazil, 14784-400 Hosp ClÃ­nicas Facult. Med. De RibeirÃ£o Preto / UspRibeirÃ£o Preto, Sao Paulo, Brazil, 14048-900 Hospital De Base Da FundaÃ§Ã£o F M S J Rio PretoSÃ£o JosÃ© Do Rio Preto, Sao Paulo, Brazil|Hamilton, Ontario, Canada, L8V 5C2 London Regional Cancer ProgramLondon, Ontario, Canada, N6A 4L6 Princess Margaret Hospital-University Health NetworkToronto, Ontario, Canada, M5G 2M9|Ottawa, Canada, K1H 8L6|Montreal, Quebec, Canada, H3T 1E2|Hefei, Anhui, China, 230001|Beijing, China, 100050 The 307Th Hospital Of Chinese People'S Liberation ArmyBeijing, China, 100071 Peking University Third HospitalBeijing, China, 100191 Beijing HospitalBeijing, China, 100730 Peking Union Medical College Hospital CamsBeijing, China, 100730 Chongqing Cancer HospitalChongqing, China, 400030 First Affiliated Hospital Of Guangzhou Medical UniversityGuangzhou, China Fudan University Shanghai Cancer CenterShanghai, China, 200032 Zhongshan Hospital, Fudan UniversityShanghai, China, 200032 Huadong Hospital, Affiliated To Fudan UniversityShanghai, China, 200040 Tianjin Medical University Cancer Institiute & HospitalTianjin, China, 300060|Fuzhou, Fujian, China, 350001 The First Affiliated Hospital Of Xiamen UniversityXiamen, Fujian, China, 361003|Guangzhou, Guangdong, China, 510060|Shijiazhuang, Hebei, China, 050000|Chengdu, Sichuan, China, 610041 The First Hospital To AmuChongqing, Sichuan, China, 400038|Wuhan, Hubei, China, 430079|Changsha, Hunan, China, 410013|Nanjing, Jiangsu, China, 210008 Jiangsu Cancer HospitalNanjing, Jiangsu, China, 210009|Nanchang, Jiangxi, China, 330006|Changchun, Jilin, China, 130021|Shengyang, Liaoning, China, 110042|Taichung, Taiwan, 40447 Taichung Veterans General HospitalTaichung, Taiwan, 40705 National Cheng Kung University HospitalTainan, Taiwan National Taiwan University HospitalTaipei, Taiwan, 10002 Taipei Veterans General HospitalTaipei, Taiwan, 11217 Chang Gung Memorial Hospital At LinkouTaoyuan, Taiwan, 333|Xi'An, Shaanxi, China, 710061|Hangzhou, Zhejiang, China, 310014 The First Affiliated Hospital Of Wenzhou Medical UniversityWenzhou, Zhejiang, China, 325000|Olomouc, Czechia, 775 20 Fakultni Nemocnice OstravaOstrava, Czechia, 708 52 Fakultni Nemocnice Kralovske VinohradyPraha 10, Czechia, 10034 Fakultni Thomayerova NemocnicePraha 4 - Krc, Czechia, 140 59 Bata HospitalZlin, Czechia, 762 75|Aarhus N, Denmark, 8200 Herlev HospitalHerlev, Denmark, 2730 H:S RigshospitaletKÃ¸benhavn, Denmark, 2100|Helsinki, Finland, 00180 Tampereen Yliopistollinen Sairaala, KeskussairaalaTampere, Finland, Fin-33520|Besancon, France, 25030 HÃ´pital Saint AndrÃ© - BordeauxBordeaux, France, 33000 Centre De Lutte Contre Le Cancer FranÃ§ois BaclesseCaen Cedex 5, France, 14076 Centre Jean PerrinClermont Ferrand Cedex 1, France, 63011 Centre Oscar Lambret - LilleLille Cedex, France, 59020 Centre LÃ©on BÃ©rardLyon Cedex, France, 69008 Institut Paoli-Calmettes - MarseilleMarseille, France, 13273 HÃ´pital Saint LouisParis, France, 75010 Cochin - ParisParis, France, 75674 HÃ´pital D'Instruction Des ArmÃ©es BeginSaint Mande, France, 94160 Clinique Saint AnneStrasbourg, France, 67000 Centre MÃ©dico-Chirurgical FochSuresnes, France, 92151|Freiburg, Baden-WÃ¼rttemberg, Germany, 79106 Eberhard-Karls-UniversitÃ¤t TÃ¼bingenTÃ¼bingen, Baden-WÃ¼rttemberg, Germany, 72076 UniversitÃ¤tsklinikum UlmUlm, Baden-WÃ¼rttemberg, Germany, 89081|Erlangen, Bayern, Germany, 91054|DÃ¼sseldorf, Nordrhein-Westfalen, Germany, 40225 UniversitÃ¤tsklinikum KÃ¶lnKÃ¶ln, Nordrhein-Westfalen, Germany, 50937|Mainz, Rheinland-Pfalz, Germany, 55131|Dresden, Sachsen, Germany, 01307|Berlin, Germany, 10967 Medizinische FakultÃ¤t Der Otto-Von-Guericke UniversitÃ¤tMagdeburg, Germany, 39120 Hong Kong Queen Mary HospitalHong Kong, Hong Kong Princess Margaret HospitalKowloon, Hong Kong Queen Elizabeth HospitalKowloon, Hong Kong Prince Of Wales HospitalShatin, Hong Kong|Budapest, Hungary, 1062 Semmelweis EgyetemBudapest, Hungary, 1082 Bajcsy Zsilinszky Korhaz-RendelointezetBudapest, Hungary, 1106 Orszagos Onkologiai IntezetBudapest, Hungary, 1122 Debreceni Egyetem Klinikai KozpontDebrecen, Hungary, 4032 Pecsi Tudomanyegyetem Klinikai KozpontPecs, Hungary, 7624|Cork, Ireland AmnchDublin, Ireland, 24 Mater Misericordiae University HospitalDublin, Ireland, 7 Mater Private HospitalDublin, Ireland, 7|Haifa, Israel, 3109601 Hadassah Hebrew University Hospital Ein KeremJerusalem, Israel, 9112001 Meir Medical CenterKfar Saba, Israel, 4428164 Rabin Medical Center - Beilinson CampusPetah Tikva, Israel, 4941492 Chaim Sheba Medical CenterRamat Gan, Israel, 5266202|ForlÃ¬-Cesena, Emilia-Romagna, Italy, 47014 Ausl ModenaModena, Emilia-Romagna, Italy, 41012 A.O.U. Di Modena - PoliclinicoModena, Emilia-Romagna, Italy, 41124|Roma, Lazio, Italy, 00128 A.O. San Camillo-ForlaniniRoma, Lazio, Italy, 00152 Fondazione Policlinico Universitario Agostino GemelliRoma, Lazio, Italy, 00168|Milano, Lombardia, Italy, 20133 Irccs Istituto Europeo Di OncologiaMilano, Lombardia, Italy, 20141 Asst Grande Ospedale Metropolitano NiguardaMilano, Lombardia, Italy, 20162|Torino, Piemonte, Italy, 10043|Bari, Puglia, Italy, 70124|Pisa, Toscana, Italy, 56126|Verona, Veneto, Italy, 37134|Nagoya, Aichi, Japan, 466-8560|Akita, Japan, 010-8543 Kyushu University HospitalFukuoka, Japan, 812-8582 Hiroshima City Hiroshima Citizens HospitalHiroshima, Japan, 730-8518 Kumamoto University HospitalKumamoto, Japan, 860-8556 Niigata University Medical And Dental HospitalNiigata, Japan, 951-8520 Osaka International Cancer InstituteOsaka, Japan, 541-8567 Tokushima University HospitalTokushima, Japan, 770-8503 Toyama University HospitalToyama, Japan, 930-0194 Korea, Republic Of, Gyeonggido National Cancer CenterGoyang-Si, Gyeonggido, Korea, Republic Of, 410-769 Korea, Republic Of Asan Medical CenterSeoul, Korea, Republic Of, 05505 Samsung Medical CenterSeoul, Korea, Republic Of, 06351 Yonsei University College Of MedicineSeoul, Korea, Republic Of, 120-752|Hirosaki, Aomori, Japan, 036-8563|Matsuyama, Ehime, Japan, 791-0280|Maebashi, Gunma, Japan, 371-8511 Gunma Prefectural Cancer CenterOta, Gunma, Japan, 373-8550|Sapporo, Hokkaido, Japan, 060-8543 Hokkaido University HospitalSapporo, Hokkaido, Japan, 060-8648|Kobe, Hyogo, Japan, 650-0047|Tsukuba, Ibaraki, Japan, 305-8576|Morioka, Iwate, Japan, 020-8505|Yokohama, Kanagawa, Japan, 236-0004|Osakasayama, Osaka, Japan, 589-8511|Hidaka, Saitama, Japan, 350-1298|Bunkyo-Ku, Tokyo, Japan, 113-8603 National Cancer Center HospitalChuo-Ku, Tokyo, Japan, 104-0045 The Cancer Institute Hospital Of JfcrKoto-Ku, Tokyo, Japan, 135-8550 Keio University HospitalShinjuku-Ku, Tokyo, Japan, 160-8582|Amsterdam, Netherlands, 1066 Cx Universitair Medisch Centrum St. RadboudNijmegen, Netherlands, 6525 Ga Erasmus Medisch CentrumRotterdam, Netherlands, 3075 Ea|Bydgoszcz, Poland, 85-796 Swietokrzyskie Centrum OnkologiiKielce, Poland, 25-734 Przychodnia Lekarska KomedKonin, Poland, 62-500 Salve Medica Sp. Z O.O. Sp.K.Lodz, Poland, 91-211 Samodzielny Publiczny Zespol Gruzlicy I Chorob PlucOlsztyn, Poland, 10-357 Sp Szpital Kliniczny Nr 2Poznan, Poland, 60-569 Uroprojekt S.C. - Gabinet UrologicznySiedlce, Poland, 08-110 Centralny Szpital Kliniczny Mswia W WarszawieWarszawa, Poland, 02-507 Uniwersytecki Szpital Kliniczny Im. J. Mikulicza-RadeckiegoWroclaw, Poland, 50-556|Coimbra, Portugal, 3000-075 Instituto PortuguÃªs De Oncologia Francisco Gentil - CoimbraCoimbra, Portugal, 3000-075 Hospital Cuf Infante SantoLisboa, Portugal, 1350-070 Centro Hospitalar De Lisboa Norte - Hospital Santa MariaLisboa, Portugal, 1649-035 Centro Hospitalar Do Porto, Epe - Hospital De Santo AntonioPorto, Portugal, 4099-001 Russian Federation Krasnoyarsk Regional Clinical Oncology DispensaryKrasnoyarsk, Russian Federation, 660133 Moscow Scient. Res. Institute Of Oncology N.A P.A. HertzenMoscow, Russian Federation, 125284 Urological Center PomcNizhny Novgorod, Russian Federation, 603109 Medical Center \"Avicenna\"Novosibirsk, Russian Federation, 630099 Clinical Oncological Dispensary Of Omsk RegionOmsk, Russian Federation, 644013 Samara Regional Clinical Oncology DispensarySamara, Russian Federation, 443031 Bashkir State Medical UniversityUfa, Russian Federation, 450008|Loures, Lisboa, Portugal, 2674-514|Bratislava, Slovakia, 833 10 Uroexam, Spol. S R.O.Nitra, Slovakia, 949 01 Poko Poprad S.R.O.Poprad, Slovakia, 085 01|CÃ³rdoba, AndalucÃ­a, Spain, 14004|Badalona, Barcelona, Spain, 08916 Institut CatalÃ  D'Oncologia HospitaletL'Hospitalet De Llobregat, Barcelona, Spain, 08907|Barcelona, Catalunya, Spain, 08003|Barcelona, Spain, 08035 Hospital San Pedro De AlcÃ¡ntaraCÃ¡ceres, Spain, 10003 Md Anderson International Espanya, S.A.Madrid, Spain, 28033 Hospital RamÃ³n Y CajalMadrid, Spain, 28034 Hospital Universitario 12 De OctubreMadrid, Spain, 28041 Hospital Virgen De La VictoriaMÃ¡laga, Spain, 29010 Instituto Valenciano De OncologÃ­aValencia, Spain, 46009 Hospital General Universitario De ValenciaValencia, Spain, 46014|Palma De Mallorca, Illes Baleares, Spain, 07120|Stockholm, Sweden, 118 83 Karolinska InstitutetStockholm, Sweden, 17167 Norrlands Universitetssjukhus, UmeÃ¥UmeÃ¥, Sweden, 901 85|Basel, Basel-Stadt, Switzerland, 4031|Chur, GraubÃ¼nden, Switzerland, 7000|Bern, Switzerland, 3010 Taiwan|St. Gallen, Sankt Gallen, Switzerland, 9007|Bebington, Merseyside, United Kingdom, Ch63 4Jy|Taunton, Somerset, United Kingdom, Ta1 5Da|London, United Kingdom, Sw3 6Jj|Anchorage, Alaska, United States, 99503|Phoenix, Arizona, United States, 85004 University Of Arizona Cancer CenterTucson, Arizona, United States, 85719|Sacramento, California, United States, 95817 Sansum ClinicSanta Barbara, California, United States, 93105|Littleton, Colorado, United States, 80120-4413|New Haven, Connecticut, United States, 06510|Orlando, Florida, United States, 32806|Chicago, Illinois, United States, 60611|Westwood, Kansas, United States, 66205|New Orleans, Louisiana, United States, 70112|Las Vegas, Nevada, United States, 89169|New York, New York, United States, 10016 Memorial Sloan-Kettering Cancer CenterNew York, New York, United States, 10065|Oklahoma City, Oklahoma, United States, 73104|Tualatin, Oregon, United States, 97062|Pittsburgh, Pennsylvania, United States, 15232|Greenville, South Carolina, United States, 29607 Carolina Urological Research CenterMyrtle Beach, South Carolina, United States, 29572|Watertown, South Dakota, United States, 57201|Denton, Texas, United States, 76210 The Center For Cancer And Blood DisordersFort Worth, Texas, United States, 76104 Houston Methodist HospitalHouston, Texas, United States, 77030-2707|Salt Lake City, Utah, United States, 84103|Seattle, Washington, United States, 98101 Summit Cancer CenterSpokane, Washington, United States, 99208","Alaska|Arizona|California|Colorado|Connecticut|Florida|Illinois|Kansas|Louisiana|Nevada|New York|Oklahoma|Oregon|Pennsylvania|South Carolina|South Dakota|Texas|Utah|Washington","Australia|Austria|Belgium|Brazil|Canada|China|Czechia|Denmark|Finland|France|Germany|Hungary|Ireland|Israel|Italy|Japan|Netherlands|Poland|Portugal|Slovakia|Spain|Sweden|Switzerland|United Kingdom|United States","New South Wales Mid North Coast Cancer Institute|Queensland Pindara Private Hospital|Victoria Monash Medical Centre|Landesklinikum Krems|OberÃ¶sterreich Krankenhaus Der Barmherzigen Schwestern Linz|Steiermark Medizinische UniversitÃ¤t Graz|Uz Gent|Rio Grande Do Sul Irmandade Santa Casa De Misericordia De Porto Alegre|Sao Paulo FundaÃ§Ã£o Pio Xii - Hospital De CÃ¢ncer De Barretos|Ontario Juravinski Cancer Centre|Ottawa Hospital-General Campus|Quebec Sir Mortimer B. Davis Jewish General Hospital|Anhui Anhui Provincial Hospital|Beijing Friendship Hospital, Capital Medical University|Fujian Fujian Medical University Union Hospital|Guangdong Sun Yat-Sen University Cancer Center|Hebei The 2Nd Hospital Of Hebei Medical University|Hospital, Sichuan University|Hubei Hubei Cancer Hospital|Hunan Hunan Cancer Hospital|Jiangsu Nj Drum Tower Hospital, The Affil Hos Of Nj Univ Med School|Jiangxi The First Affiliated Hospital Of Nanchang University|Jilin The First Hospital Of Jilin University|Liaoning Liaoning Cancer Hospital And Institute|Medical University Hospital|Shaanxi 1St Affiliated Hospital Of Xi'An Jiaotong Medical University|Zhejiang Zhejiang Provincial People's Hospital|Fakultni Nemocnice Olomouc|Aarhus Universitetshospital, Skejby|Docrates Klinikka|Hopital Jean Minjoz|Baden-WÃ¼rttemberg UniversitÃ¤tsklinikum Freiburg|Bayern UniversitÃ¤tsklinikum Erlangen|Nordrhein-Westfalen Heinrich-Heine-UniversitÃ¤t DÃ¼sseldorf|Rheinland-Pfalz UniversitÃ¤tsmedizin Der Johannes Gutenberg UniversitÃ¤t Mainz|Sachsen Medizinische FakultÃ¤t Carl Gustav Carus|Vivantes Klinikum Am Urban|Mh Egeszsegugyi Kozpont|Cork University Hospital|Rambam Health Corporation|Emilia-Romagna Irst Istituto Scientifico Romagnolo Per Studio E Cura Tumori|Lazio Policlinico Universitario Campus Biomedico|Lombardia Fondazione Irccs Istituto Nazionale Dei Tumori|Piemonte A.O.U. San Luigi Gonzaga|Puglia Irccs Ist.Tumori Giovanni Paolo Ii - Osp. Oncologico Bari|Toscana A.O.U. Pisana|Veneto A.O.U. Integrata Verona|Aichi Nagoya University Hospital|Akita University Hospital|Aomori Hirosaki University Hospital|Ehime National Hospital Organization Shikoku Cancer Center|Gunma Gunma University Hospital|Hokkaido Sapporo Medical University Hospital|Hyogo Kobe City Medical Center General Hospital|Ibaraki University Of Tsukuba Hospital|Iwate Iwate Medical University Hospital|Kanagawa Yokohama City University Hospital|Osaka Kindai University Hospital|Saitama Saitama Medical University International Medical Center|Tokyo Nippon Medical School Hospital|Nederlands Kanker Instituut|Centrum Onkologii Im. Prof. Franciszka Lukaszczyka|Chuc - Hospitais Da Universidade De Coimbra|Lisboa Hospital Beatriz Angelo|Narodny Onkologicky Ustav|AndalucÃ­a Hospital Reina SofÃ­a|Barcelona Institut CatalÃ  D'Oncologia Badalona|Catalunya Hospital Del Mar|Ciutat SanitÃ ria I Universitaria De La Vall D'Hebron|Illes Baleares Hospital Universitari Son Espases|SÃ¶dersjukhuset|Basel-Stadt UniversitÃ¤tsspital Basel|GraubÃ¼nden Kantonsspital GraubÃ¼nden|Inselspital UniversitÃ¤tsspital Bern|Sankt Gallen Kantonsspital St. Gallen|, Merseyside Clatterbridge Centre For Oncology|, Somerset Musgrove Park Hospital|The Royal Marsden Hospital|Alaska Clinical Research Center, Llc|Univeristy Of Arizona Cancer Center|Uc Davis Comprehensive Cancer Center|Rocky Mountain Cancer Centers|Yale Cancer Center|Uf Cancer Center At Orlando Health|Northwestern Medical Faculty Foundation Div Of Hem/Oncology|University Of Kansas Medical Center|Louisiana State University|Comprehensive Cancer Centers Of Nevada|Nyu Langone Medical Center|Oklahoma University Health Science Center|Compass Oncology|University Of Pittsburgh|Bon Secours St. Francis Hospital|Prairie Lakes Cancer Center|Texas Oncology-Denton South|Huntsman Cancer Institute- University Of Utah|Virginia Mason Medical Center",{"$nulls":3},"Bayer Study Director","2018-12-17","2020-05-25T16:38:41.120","2020-05-26T17:10:42.972","NCT03410693"]
["5ecbf491fe30261b1a048349","NCT03410693","2019-03-15","Bayer","BAYN","Active, not recruiting","Study of Rogaratinib (BAY1163877) vs Chemotherapy in Patients With FGFR (Fibroblast Growth Factor Receptor)-Positive Locally Advanced or Metastatic Urothelial Carcinoma (FORT-1)","Bay-1163877",null,"Yes","['Bay-1163877']","Unknown",null,"Phase 2/Phase 3",2,175,"Actual","2018-05-31","2022-04-25","OS","Overall Survival",{"$nulls":3},"This is a randomized, open-label, multicenter Phase 2/3 study to evaluate the efficacy and safety of rogaratinib (BAY 1163877) compared to chemotherapy in patients with FGFRpositive locally advanced or metastatic urothelial carcinoma who have received Prior platinum-containing chemotherapy.\n\nThe primary objective of the entire study is to compare rogaratinib (BAY1163877) with chemotherapy (docetaxel, paclitaxel or vinflunine) in terms of prolonging the Overall survival (OS) of patients with FGFR positive urothelial carcinoma.\n\nAt randomization, patients will have locally advanced or metastatic urothelial carcinoma and have received at least one prior platinum-containing chemotherapy regimen. Only patients with FGFR1 or 3 positive tumors can be randomized into the study. Archival tumor tissue is adequate for testing of FGFR1 and 3 mRNA expressions, which will be determined centrally using an RNA in situ hybridization (RNA-ISH) test. Approximately 42 % of UC patients with locally advanced or metastatic UC are identified as FGFR-positive by the RNA-ISH cut-off applied.",null,"A Randomized, Open Label, Multicenter Phase 2/3 Study to Evaluate the Efficacy and Safety of Rogaratinib (BAY1163877) Compared to Chemotherapy in Patients With FGFR-positive Locally Advanced or Metastatic Urothelial Carcinoma Who Have Received Prior Platinum-containing Chemotherapy",17403,"Carcinoma, Transitional Cell","Noma|Carcinoma|Transitional Cell Carcinoma","Mouth Diseases|Oncology Solid Tumor","Ear, Nose and Throat|Oncology","Experimental|Active Comparator","Rogaratinib|Chemotherapy",null,"Drug","Rogaratinib (BAY1163877)|Chemotherapy","Rogaratinib administered as oral (p.o.) tablets twice daily (b.i.d.) continuously|Chemotherapy as taxane (docetaxel or paclitaxel) or vinflunine administered through intravenous (i.v.) infusion every 3 weeks (on day 1 of a 21-day cycle) The choice of the chemotherapy is at the discretion of the investigator, taking into consideration the status of the authorization in the given Country (i.e. the drug has to be approved at least for one indication in the given country).",null,"Rogaratinib|Chemotherapy","\n\n * Existence of archival or fresh biopsy for FGFR testing\n * FGFR testing of patients will be performed at the investigators' discretion up to a max. of 90 days prior to start of screening.\n\nInvestigators should ensure all patients will be eligible in terms of disease status and lines of treatment within this timeframe.\n\n * Documented urothelial carcinoma (transitional cell carcinoma) including urinary bladder, renal pelvis, ureters, urethra meeting all of the following criteria * Histologically or cytologically confirmed (patients with mixed histologies are required to have a dominant transitional cell pattern.)\n    * Locally advanced (T4b, any N; or any T, N 2âˆ’3) or metastatic disease (any T, any N and M1). Locally advanced bladder cancer must be unresectable i.e. invading the pelvic or abdominal wall (stage T4b) or presenting with bulky nodal disease (N2-3).\n   \n   \n * ECOG (Eastern Cooperative Oncology Group) Performance Status of 0 or 1\n * Disease progression during or following treatment with at least one platinum-containing regimen (patients should have been treated for at least 2 cycles). In patients who received prior adjuvant/ neoadjuvant platinum-containing chemotherapy, progression had to occur within 12 months of treatment.\n * High FGFR1 or 3 mRNA (Messenger ribonucleic acid) expression levels (RNAscope score of 3+ or 4+; measurement is part of this protocol) in archival or fresh Tumor biopsy specimen\n * At least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST v.1.1) in contrast enhanced (unless contraindicated) CT or MRI\n\n","\n\n * Previous or concurrent cancer except * cervical carcinoma in situ\n    * treated basal-cell or squamous cell skin carcinoma\n    * any cancer curatively treated > 3 years before randomization\n    * curatively treated incidental prostate cancer (T1/T2a)\n   \n   \n * Ongoing or previous anti-cancer treatment within 4 weeks before randomization.\n * More than two prior lines of systemic anti-cancer therapy for urothelial carcinoma\n * Ongoing or previous treatment with anti-FGFR directed therapies (e.g. receptor tyrosine kinase inhibitors including rogaratinib or FGFRspecific antibodies) or with taxanes or vinflunine\n * Unresolved toxicity higher than National Cancer Institute's Common Terminology Criteria for Adverse Events, version 4.03 (CTCAE v.4.03) Grade 1 attributed to any prior therapy/ procedure excluding alopecia, anemia and/ or hypothyroidism\n * History or current condition of an uncontrolled cardiovascular disease including any of the following conditions: * Congestive heart failure (CHF) NYHA (New York Heart Association) > Class 2\n    * Unstable angina (symptoms of angina at rest) or new-onset angina (within last 3 months before randomization)\n    * Myocardial infarction (MI) within past 6 months before randomization\n    * Unstable cardiac arrhythmias requiring anti-arrhythmic therapy. Patients with arrhythmia under control with anti-arrhythmic therapy such as beta-blockers or digoxin are eligible.\n   \n   \n * Arterial or venous thrombotic events or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within 3 months before randomization\n * Current evidence of endocrine alteration of calcium phosphate homeostasis (e.g. parathyroid disorder, history of parathyroidectomy, tumor lysis, tumoral calcinosis, paraneoplastic hypercalcemia)\n * Any hemorrhage / bleeding event â‰¥ CTCAE v.4.03 Grade 3 within 4 weeks before randomization\n * Current diagnosis of any retinal detachment, retinal pigment epithelial detachment (RPED), serous retinopathy or retinal vein occlusion",{"$nulls":4},"Actual","2018-01-25","Actual","Anticipated","2022-04-25","Anticipated","2019-03-01","2018-01-19","2018-01-19","2019-03-14","Yes","Urothelial carcinoma","Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"2016-004340-11","EudraCT Number","Overall Survival","Defined as the time (days) from randomization to death due to any cause. Patients alive at the date of data cut-off for analysis will be censored at the last date known to be alive.","Up to 45 months","Progression-free survival (PFS)|Objective response rate (ORR)|Disease-control rate (DCR)|Duration of response (DOR)|Incidence of Adverse Events as a measure of safety and tolerability","Defined as the time (days) from randomization to date of first observed disease progression (radiological or clinical assessment) or death due to any cause, if death occurs before progression is documented. For patients without documented radiological or clinical progression or death at the time of analysis, PFS will be censored at the last actual visit date of tumor evaluation.|Defined as the percentage of patients with complete response (CR) or partial Response (PR). Patients for whom overall best response is not CR or PR, as well as patients without any post-baseline tumor assessment will be considered non-responders.|Defined as the percentage of patients, whose overall best response was not progressive disease|Defined as the time from the first documented objective response of PR or CR, whichever is noted earlier, to disease progression or death (if death occurs before progression is documented). DOR will be defined for responders only, i.e. patients with a CR or PR.|Up to 45 months","Up to 45 months|PD (i.e. CR, PR, Stable Disease",{"$nulls":3},"Coffs Harbour, New South Wales, Australia, 2450 Northern Cancer InstituteSt Leonards, New South Wales, Australia, 2065 Macquarie University HospitalSydney, New South Wales, Australia, 2109 Riverina Cancer Care CentreWagga Wagga, New South Wales, Australia, 2650 Sydney Adventist HospitalWahroonga, New South Wales, Australia, 2076|Benowa, Queensland, Australia, 4217|Clayton, Victoria, Australia, 3168|Krems, Austria, 3500 Krankenhaus Der Barmherzigen BrÃ¼derWien, Austria, 1020 Allgemeines Krankenhaus Der Stadt WienWien, Austria, 1090 Wilhelminenspital Der Stadt WienWien, Austria, 1160|Linz, OberÃ¶sterreich, Austria, 4020|Graz, Steiermark, Austria, 8036|Gent, Belgium, 9000 Ch De Jolimont - Lobbes Site De JolimontLa Louviere, Belgium, 7100 Uz Leuven GasthuisbergLeuven, Belgium, 3000 Chu De LiÃ¨geLiege, Belgium, 4000 Clinique Saint-PierreOttignies, Belgium, 1340|Hamilton, Ontario, Canada, L8V 5C2 Princess Margaret Hospital-University Health NetworkToronto, Ontario, Canada, M5G 2M9|Ottawa, Canada, K1H 8L6|Montreal, Quebec, Canada, H3T 1E2|Hefei, Anhui, China, 230001|Beijing, China, 100050 The 307Th Hospital Of Chinese People'S Liberation ArmyBeijing, China, 100071 Peking University Third HospitalBeijing, China, 100191 Beijing HospitalBeijing, China, 100730 Peking Union Medical College Hospital CamsBeijing, China, 100730 Chongqing Cancer HospitalChongqing, China, 400030 First Affiliated Hospital Of Guangzhou Medical UniversityGuangzhou, China Fudan University Shanghai Cancer CenterShanghai, China, 200032 Zhongshan Hospital, Fudan UniversityShanghai, China, 200032 Huadong Hospital, Affiliated To Fudan UniversityShanghai, China, 200040 Tianjin Medical University Cancer Institiute & HospitalTianjin, China, 300060|Fuzhou, Fujian, China, 350001 The First Affiliated Hospital Of Xiamen UniversityXiamen, Fujian, China, 361003|Guangzhou, Guangdong, China, 510060|Shijiazhuang, Hebei, China, 050000|Chengdu, Sichuan, China, 610041 The First Hospital To AmuChongqing, Sichuan, China, 400038|Wuhan, Hubei, China, 430079|Changsha, Hunan, China, 410013|Nanjing, Jiangsu, China, 210008 Jiangsu Cancer HospitalNanjing, Jiangsu, China, 210009|Nanchang, Jiangxi, China, 330006|Changchun, Jilin, China, 130021|Shengyang, Liaoning, China, 110042|Taichung, Taiwan, 40447 Taichung Veterans General HospitalTaichung, Taiwan, 40705 National Cheng Kung University HospitalTainan, Taiwan National Taiwan University HospitalTaipei, Taiwan, 10002 Taipei Veterans General HospitalTaipei, Taiwan, 11217 Chang Gung Memorial Hospital At LinkouTaoyuan, Taiwan, 333|Xi'An, Shaanxi, China, 710061|Hangzhou, Zhejiang, China, 310014 The First Affiliated Hospital Of Wenzhou Medical UniversityWenzhou, Zhejiang, China, 325000|Ostrava, Czechia, 708 52 Fakultni Nemocnice Kralovske VinohradyPraha 10, Czechia, 10034 Fakultni Thomayerova NemocnicePraha 4 - Krc, Czechia, 140 59 Bata HospitalZlin, Czechia, 762 75|Aarhus N, Denmark, 8200 Herlev HospitalHerlev, Denmark, 2730 H:S RigshospitaletKÃ¸benhavn, Denmark, 2100|Helsinki, Finland, 00180 Tampereen Yliopistollinen Sairaala, KeskussairaalaTampere, Finland, Fin-33520|Besancon, France, 25030 HÃ´pital Saint AndrÃ© - BordeauxBordeaux, France, 33000 Centre De Lutte Contre Le Cancer FranÃ§ois BaclesseCaen Cedex 5, France, 14076 Centre Jean PerrinClermont Ferrand Cedex 1, France, 63011 Centre Oscar Lambret - LilleLille Cedex, France, 59020 Centre LÃ©on BÃ©rardLyon Cedex, France, 69008 Institut Paoli-Calmettes - MarseilleMarseille, France, 13273 HÃ´pital Saint LouisParis, France, 75010 Cochin - ParisParis, France, 75674 HÃ´pital D'Instruction Des ArmÃ©es BeginSaint Mande, France, 94160 Clinique Saint AnneStrasbourg, France, 67000 Centre MÃ©dico-Chirurgical FochSuresnes, France, 92151|Freiburg, Baden-WÃ¼rttemberg, Germany, 79106 Eberhard-Karls-UniversitÃ¤t TÃ¼bingenTÃ¼bingen, Baden-WÃ¼rttemberg, Germany, 72076 UniversitÃ¤tsklinikum UlmUlm, Baden-WÃ¼rttemberg, Germany, 89081|Erlangen, Bayern, Germany, 91054|DÃ¼sseldorf, Nordrhein-Westfalen, Germany, 40225|Mainz, Rheinland-Pfalz, Germany, 55131|Dresden, Sachsen, Germany, 01307|Berlin, Germany, 10967 Medizinische FakultÃ¤t Der Otto-Von-Guericke UniversitÃ¤tMagdeburg, Germany, 39120 Hong Kong Queen Mary HospitalHong Kong, Hong Kong Princess Margaret HospitalKowloon, Hong Kong Queen Elizabeth HospitalKowloon, Hong Kong Prince Of Wales HospitalShatin, Hong Kong|Budapest, Hungary, 1062 Semmelweis EgyetemBudapest, Hungary, 1082 Bajcsy Zsilinszky Korhaz-RendelointezetBudapest, Hungary, 1106 Orszagos Onkologiai IntezetBudapest, Hungary, 1122 Debreceni Egyetem Klinikai KozpontDebrecen, Hungary, 4032 Pecsi Tudomanyegyetem Klinikai KozpontPecs, Hungary, 7624|Cork, Ireland AmnchDublin, Ireland, 24|Haifa, Israel, 3109601 Hadassah Hebrew University Hospital Ein KeremJerusalem, Israel, 9112001 Meir Medical CenterKfar Saba, Israel, 4428164 Rabin Medical Center - Beilinson CampusPetah Tikva, Israel, 4941492 Chaim Sheba Medical CenterRamat Gan, Israel, 5266202|ForlÃ¬-Cesena, Emilia-Romagna, Italy, 47014 Ausl ModenaModena, Emilia-Romagna, Italy, 41012 A.O.U. Di Modena - PoliclinicoModena, Emilia-Romagna, Italy, 41124|Roma, Lazio, Italy, 00152 Fondazione Policlinico Universitario Agostino GemelliRoma, Lazio, Italy, 00168|Milano, Lombardia, Italy, 20133 Irccs Istituto Europeo Di Oncologia (Ieo)Milano, Lombardia, Italy, 20141 Asst Grande Ospedale Metropolitano NiguardaMilano, Lombardia, Italy, 20162|Torino, Piemonte, Italy, 10043|Bari, Puglia, Italy, 70124|Pisa, Toscana, Italy, 56126|Verona, Veneto, Italy, 37134|Nagoya, Aichi, Japan, 466-8560|Akita, Japan, 010-8543 Kyushu University HospitalFukuoka, Japan, 812-8582 Hiroshima City Hiroshima Citizens HospitalHiroshima, Japan, 730-8518 Kumamoto University HospitalKumamoto, Japan, 860-8556 Niigata University Medical And Dental HospitalNiigata, Japan, 951-8520 Osaka International Cancer InstituteOsaka, Japan, 541-8567 Tokushima University HospitalTokushima, Japan, 770-8503 Toyama University HospitalToyama, Japan, 930-0194 Korea, Republic Of, Gyeonggido National Cancer CenterGoyang-Si, Gyeonggido, Korea, Republic Of, 410-769 Korea, Republic Of Asan Medical CenterSeoul, Korea, Republic Of, 05505 Samsung Medical CenterSeoul, Korea, Republic Of, 06351 Yonsei University College Of MedicineSeoul, Korea, Republic Of, 120-752|Hirosaki, Aomori, Japan, 036-8563|Matsuyama, Ehime, Japan, 791-0280|Maebashi, Gunma, Japan, 371-8511 Gunma Prefectural Cancer CenterOta, Gunma, Japan, 373-8550|Sapporo, Hokkaido, Japan, 060-8543 Hokkaido University HospitalSapporo, Hokkaido, Japan, 060-8648|Kobe, Hyogo, Japan, 650-0047|Tsukuba, Ibaraki, Japan, 305-8576|Morioka, Iwate, Japan, 020-8505|Yokohama, Kanagawa, Japan, 236-0004|Osakasayama, Osaka, Japan, 589-8511|Hidaka, Saitama, Japan, 350-1298|Bunkyo-Ku, Tokyo, Japan, 113-8603 National Cancer Center HospitalChuo-Ku, Tokyo, Japan, 104-0045 The Cancer Institute Hospital Of JfcrKoto-Ku, Tokyo, Japan, 135-8550 Keio University HospitalShinjuku-Ku, Tokyo, Japan, 160-8582|Amsterdam, Netherlands, 1066 Cx Erasmus Medisch CentrumRotterdam, Netherlands, 3075 Ea|Bydgoszcz, Poland, 85-796 Swietokrzyskie Centrum OnkologiiKielce, Poland, 25-734 Przychodnia Lekarska KomedKonin, Poland, 62-500 Salve Medica Sp. Z O.O. Sp.K.Lodz, Poland, 91-211 Samodzielny Publiczny Zespol Gruzlicy I Chorob PlucOlsztyn, Poland, 10-357 Sp Szpital Kliniczny Nr 2Poznan, Poland, 60-569 Uniwersytecki Szpital Kliniczny Im. J. Mikulicza-RadeckiegoWroclaw, Poland, 50-556|Coimbra, Portugal, 3000-075 Instituto PortuguÃªs De Oncologia Francisco Gentil - CoimbraCoimbra, Portugal, 3000-075 Hospital Cuf Infante SantoLisboa, Portugal, 1350-070 Centro Hospitalar De Lisboa Norte - Hospital Santa MariaLisboa, Portugal, 1649-035 Chup, Epe - Hospital De Santo AntonioPorto, Portugal, 4099-001 Russian Federation Krasnoyarsk Regional Clinical Oncology DispensaryKrasnoyarsk, Russian Federation, 660133 Moscow Scient. Res. Institute Of Oncology N.A P.A. HertzenMoscow, Russian Federation, 125284 Urological Center PomcNizhny Novgorod, Russian Federation, 603109 Clinical Oncological Dispensary Of Omsk RegionOmsk, Russian Federation, 644013 Samara Regional Clinical Oncology DispensarySamara, Russian Federation, 443031 Bashkir State Medical UniversityUfa, Russian Federation, 450008|Loures, Lisboa, Portugal, 2674-514|Bratislava, Slovakia, 833 10 Uroexam, Spol. S R.O.Nitra, Slovakia, 949 01 Poko Poprad S.R.O.Poprad, Slovakia, 085 01|CÃ³rdoba, AndalucÃ­a, Spain, 14004|Badalona, Barcelona, Spain, 08916 Institut CatalÃ  D'Oncologia HospitaletL'Hospitalet De Llobregat, Barcelona, Spain, 08907|Barcelona, Catalunya, Spain, 08003|Barcelona, Spain, 08035 Hospital San Pedro De AlcÃ¡ntaraCÃ¡ceres, Spain, 10003 Md Anderson International Espanya, S.A.Madrid, Spain, 28033 Hospital RamÃ³n Y CajalMadrid, Spain, 28034 Hospital Universitario 12 De OctubreMadrid, Spain, 28041 Hospital Virgen De La VictoriaMÃ¡laga, Spain, 29010 Instituto Valenciano De OncologÃ­aValencia, Spain, 46009 Hospital General Universitario De ValenciaValencia, Spain, 46014|Palma De Mallorca, Illes Baleares, Spain, 07120|Stockholm, Sweden, 118 83 Karolinska InstitutetStockholm, Sweden, 17167 Norrlands Universitetssjukhus, UmeÃ¥UmeÃ¥, Sweden, 901 85|Basel, Basel-Stadt, Switzerland, 4031|Chur, GraubÃ¼nden, Switzerland, 7000|Bern, Switzerland, 3010 UniversitÃ¤tsspital ZÃ¼richZÃ¼rich, Switzerland, 8091 Taiwan|St. Gallen, Sankt Gallen, Switzerland, 9007|Bebington, Merseyside, United Kingdom, Ch63 4Jy|Taunton, Somerset, United Kingdom, Ta1 5Da|London, United Kingdom, Sw3 6Jj|Anchorage, Alaska, United States, 99503|Phoenix, Arizona, United States, 85004 University Of Arizona Cancer CenterTucson, Arizona, United States, 85719|Los Angeles, California, United States, 90033 Uc Davis Comprehensive Cancer CenterSacramento, California, United States, 95817 Sansum ClinicSanta Barbara, California, United States, 93105|Littleton, Colorado, United States, 80120-4413|New Haven, Connecticut, United States, 06510|Orlando, Florida, United States, 32806|Chicago, Illinois, United States, 60611|Westwood, Kansas, United States, 66205|New Orleans, Louisiana, United States, 70112|Las Vegas, Nevada, United States, 89169|New York, New York, United States, 10016 Weill Cornell Medical CollegeNew York, New York, United States, 10065|Tualatin, Oregon, United States, 97062|Pittsburgh, Pennsylvania, United States, 15232|Greenville, South Carolina, United States, 29607|Watertown, South Dakota, United States, 57201|Denton, Texas, United States, 76210 The Center For Cancer And Blood DisordersFort Worth, Texas, United States, 76104 Houston Methodist HospitalHouston, Texas, United States, 77030-2707|Seattle, Washington, United States, 98101 Summit Cancer CenterSpokane, Washington, United States, 99208","Alaska|Arizona|California|Colorado|Connecticut|Florida|Illinois|Kansas|Louisiana|Nevada|New York|Oregon|Pennsylvania|South Carolina|South Dakota|Texas|Washington","Australia|Austria|Belgium|Canada|China|Czechia|Denmark|Finland|France|Germany|Hungary|Ireland|Israel|Italy|Japan|Netherlands|Poland|Portugal|Slovakia|Spain|Sweden|Switzerland|United Kingdom|United States","New South Wales Mid North Coast Cancer Institute|Queensland Pindara Private Hospital|Victoria Monash Medical Centre|Landesklinikum Krems|OberÃ¶sterreich Krankenhaus Der Elisabethinen Linz Gmbh|Steiermark Medizinische UniversitÃ¤t Graz|Uz Gent|Ontario Juravinski Cancer Centre|Ottawa Hospital-General Campus|Quebec Sir Mortimer B. Davis Jewish General Hospital|Anhui Anhui Provincial Hospital|Beijing Friendship Hospital, Capital Medical University|Fujian Fujian Medical University Union Hospital|Guangdong Sun Yat-Sen University Cancer Center|Hebei The 2Nd Hospital Of Hebei Medical University|Hospital, Sichuan University|Hubei Hubei Cancer Hospital|Hunan Hunan Cancer Hospital|Jiangsu Nj Drum Tower Hospital, The Affil Hos Of Nj Univ Med School|Jiangxi The First Affiliated Hospital Of Nanchang University|Jilin The First Hospital Of Jilin University|Liaoning Liaoning Cancer Hospital And Institute|Medical University Hospital|Shaanxi 1St Affiliated Hospital Of Xi'An Jiaotong Medical University|Zhejiang Zhejiang Provincial People's Hospital|Fakultni Nemocnice Ostrava|Aarhus Universitetshospital, Skejby|Docrates Klinikka|Hopital Jean Minjoz|Baden-WÃ¼rttemberg UniversitÃ¤tsklinikum Freiburg|Bayern UniversitÃ¤tsklinikum Erlangen|Nordrhein-Westfalen Heinrich-Heine-UniversitÃ¤t DÃ¼sseldorf|Rheinland-Pfalz UniversitÃ¤tsmedizin Der Johannes Gutenberg UniversitÃ¤t Mainz|Sachsen UniversitÃ¤tsklinikum Carl Gustav Carus Dresden|Vivantes Klinikum Am Urban|Mh Egeszsegugyi Kozpont|Cork University Hospital|Rambam Health Corporation|Emilia-Romagna Irst Istituto Scientifico Romagnolo Per Studio E Cura Tumori|Lazio A.O. San Camillo-Forlanini|Lombardia Fondazione Irccs Istituto Nazionale Dei Tumori|Piemonte A.O.U. San Luigi Gonzaga|Puglia Irccs Ist.Tumori Giovanni Paolo Ii - Osp. Oncologico Bari|Toscana A.O.U. Pisana|Veneto A.O.U. Integrata Verona|Aichi Nagoya University Hospital|Akita University Hospital|Aomori Hirosaki University Hospital|Ehime National Hospital Organization Shikoku Cancer Center|Gunma Gunma University Hospital|Hokkaido Sapporo Medical University Hospital|Hyogo Kobe City Medical Center General Hospital|Ibaraki University Of Tsukuba Hospital|Iwate Iwate Medical University Hospital|Kanagawa Yokohama City University Hospital|Osaka Kindai University Hospital|Saitama Saitama Medical University International Medical Center|Tokyo Nippon Medical School Hospital|Nederlands Kanker Instituut|Centrum Onkologii Im. Prof. Franciszka Lukaszczyka|Chuc - Hospitais Da Universidade De Coimbra|Lisboa Hospital Beatriz Angelo|Narodny Onkologicky Ustav|AndalucÃ­a Hospital Reina SofÃ­a|Barcelona Institut CatalÃ  D'Oncologia Badalona|Catalunya Hospital Del Mar|Ciutat SanitÃ ria I Universitaria De La Vall D'Hebron|Illes Baleares Hospital Universitari Son Espases|SÃ¶dersjukhuset|Basel-Stadt UniversitÃ¤tsspital Basel|GraubÃ¼nden Kantonsspital GraubÃ¼nden|Inselspital UniversitÃ¤tsspital Bern|Sankt Gallen Kantonsspital St. Gallen|, Merseyside Clatterbridge Centre For Oncology|, Somerset Musgrove Park Hospital|The Royal Marsden Hospital|Alaska Clinical Research Center, Llc|Univeristy Of Arizona Cancer Center|University Of Southern California|Rocky Mountain Cancer Centers|Yale Cancer Center|Uf Cancer Center At Orlando Health|Northwestern Medical Faculty Foundation Div Of Hem/Oncology|University Of Kansas Medical Center|Louisiana State University|Comprehensive Cancer Centers Of Nevada|Nyu Langone Medical Center|Compass Oncology|University Of Pittsburgh|Bon Secours St. Francis Hospital|Prairie Lakes Cancer Center|Texas Oncology-Denton South|Virginia Mason Medical Center",{"$nulls":3},"Bayer Study Director","2019-03-14","2020-05-25T16:38:41.494","2020-05-26T17:10:42.972","NCT03410693"]
["5ecbf491307e3d1b1f8d9dda","NCT03410693","2019-06-18","Bayer","BAYN","Active, not recruiting","Study of Rogaratinib (BAY1163877) vs Chemotherapy in Patients With FGFR (Fibroblast Growth Factor Receptor)-Positive Locally Advanced or Metastatic Urothelial Carcinoma (FORT-1)","Bay-1163877",null,"Yes","['Bay-1163877']","Unknown",null,"Phase 2/Phase 3",2,175,"Actual","2018-05-31","2022-04-25","OS","Overall Survival",{"$nulls":3},"This is a randomized, open-label, multicenter Phase 2/3 study to evaluate the efficacy and safety of rogaratinib (BAY 1163877) compared to chemotherapy in patients with FGFRpositive locally advanced or metastatic urothelial carcinoma who have received Prior platinum-containing chemotherapy.\n\nThe primary objective of the entire study is to compare rogaratinib (BAY1163877) with chemotherapy (docetaxel, paclitaxel or vinflunine) in terms of prolonging the Overall survival (OS) of patients with FGFR positive urothelial carcinoma.\n\nAt randomization, patients will have locally advanced or metastatic urothelial carcinoma and have received at least one prior platinum-containing chemotherapy regimen. Only patients with FGFR1 or 3 positive tumors can be randomized into the study. Archival tumor tissue is adequate for testing of FGFR1 and 3 mRNA expressions, which will be determined centrally using an RNA in situ hybridization (RNA-ISH) test. Approximately 42 % of UC patients with locally advanced or metastatic UC are identified as FGFR-positive by the RNA-ISH cut-off applied.",null,"A Randomized, Open Label, Multicenter Phase 2/3 Study to Evaluate the Efficacy and Safety of Rogaratinib (BAY1163877) Compared to Chemotherapy in Patients With FGFR-positive Locally Advanced or Metastatic Urothelial Carcinoma Who Have Received Prior Platinum-containing Chemotherapy",17403,"Carcinoma, Transitional Cell","Noma|Carcinoma|Transitional Cell Carcinoma","Mouth Diseases|Oncology Solid Tumor","Ear, Nose and Throat|Oncology","Experimental|Active Comparator","Rogaratinib|Chemotherapy",null,"Drug","Rogaratinib (BAY1163877)|Chemotherapy","Rogaratinib administered as oral (p.o.) tablets twice daily (b.i.d.) continuously|Chemotherapy as taxane (docetaxel or paclitaxel) or vinflunine administered through intravenous (i.v.) infusion every 3 weeks (on day 1 of a 21-day cycle) The choice of the chemotherapy is at the discretion of the investigator, taking into consideration the status of the authorization in the given Country (i.e. the drug has to be approved at least for one indication in the given country).",null,"Rogaratinib|Chemotherapy","\n\n * Existence of archival or fresh biopsy for FGFR testing\n * FGFR testing of patients will be performed at the investigators' discretion up to a max. of 90 days prior to start of screening.\n\nInvestigators should ensure all patients will be eligible in terms of disease status and lines of treatment within this timeframe.\n\n * Documented urothelial carcinoma (transitional cell carcinoma) including urinary bladder, renal pelvis, ureters, urethra meeting all of the following criteria * Histologically or cytologically confirmed (patients with mixed histologies are required to have a dominant transitional cell pattern.)\n    * Locally advanced (T4b, any N; or any T, N 2âˆ’3) or metastatic disease (any T, any N and M1). Locally advanced bladder cancer must be unresectable i.e. invading the pelvic or abdominal wall (stage T4b) or presenting with bulky nodal disease (N2-3).\n   \n   \n * ECOG (Eastern Cooperative Oncology Group) Performance Status of 0 or 1\n * Disease progression during or following treatment with at least one platinum-containing regimen (patients should have been treated for at least 2 cycles). In patients who received prior adjuvant/ neoadjuvant platinum-containing chemotherapy, progression had to occur within 12 months of treatment.\n * High FGFR1 or 3 mRNA (Messenger ribonucleic acid) expression levels (RNAscope score of 3+ or 4+; measurement is part of this protocol) in archival or fresh Tumor biopsy specimen\n * At least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST v.1.1) in contrast enhanced (unless contraindicated) CT or MRI\n\n","\n\n * Previous or concurrent cancer except * cervical carcinoma in situ\n    * treated basal-cell or squamous cell skin carcinoma\n    * any cancer curatively treated > 3 years before randomization\n    * curatively treated incidental prostate cancer (T1/T2a)\n   \n   \n * Ongoing or previous anti-cancer treatment within 4 weeks before randomization.\n * More than two prior lines of systemic anti-cancer therapy for urothelial carcinoma\n * Ongoing or previous treatment with anti-FGFR directed therapies (e.g. receptor tyrosine kinase inhibitors including rogaratinib or FGFRspecific antibodies) or with taxanes or vinflunine\n * Unresolved toxicity higher than National Cancer Institute's Common Terminology Criteria for Adverse Events, version 4.03 (CTCAE v.4.03) Grade 1 attributed to any prior therapy/ procedure excluding alopecia, anemia and/ or hypothyroidism\n * History or current condition of an uncontrolled cardiovascular disease including any of the following conditions: * Congestive heart failure (CHF) NYHA (New York Heart Association) > Class 2\n    * Unstable angina (symptoms of angina at rest) or new-onset angina (within last 3 months before randomization)\n    * Myocardial infarction (MI) within past 6 months before randomization\n    * Unstable cardiac arrhythmias requiring anti-arrhythmic therapy. Patients with arrhythmia under control with anti-arrhythmic therapy such as beta-blockers or digoxin are eligible.\n   \n   \n * Arterial or venous thrombotic events or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within 3 months before randomization\n * Current evidence of endocrine alteration of calcium phosphate homeostasis (e.g. parathyroid disorder, history of parathyroidectomy, tumor lysis, tumoral calcinosis, paraneoplastic hypercalcemia)\n * Any hemorrhage / bleeding event â‰¥ CTCAE v.4.03 Grade 3 within 4 weeks before randomization\n * Current diagnosis of any retinal detachment, retinal pigment epithelial detachment (RPED), serous retinopathy or retinal vein occlusion",{"$nulls":4},"Actual","2018-01-25","Actual","Anticipated","2022-04-25","Anticipated","2019-06-01","2018-01-19","2018-01-19","2019-06-17","Yes","Urothelial carcinoma","Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"2016-004340-11","EudraCT Number","Overall Survival","Defined as the time (days) from randomization to death due to any cause. Patients alive at the date of data cut-off for analysis will be censored at the last date known to be alive.","Up to 45 months","Progression-free survival (PFS)|Objective response rate (ORR)|Disease-control rate (DCR)|Duration of response (DOR)|Incidence of Adverse Events as a measure of safety and tolerability","Defined as the time (days) from randomization to date of first observed disease progression (radiological or clinical assessment) or death due to any cause, if death occurs before progression is documented. For patients without documented radiological or clinical progression or death at the time of analysis, PFS will be censored at the last actual visit date of tumor evaluation.|Defined as the percentage of patients with complete response (CR) or partial Response (PR). Patients for whom overall best response is not CR or PR, as well as patients without any post-baseline tumor assessment will be considered non-responders.|Defined as the percentage of patients, whose overall best response was not progressive disease|Defined as the time from the first documented objective response of PR or CR, whichever is noted earlier, to disease progression or death (if death occurs before progression is documented). DOR will be defined for responders only, i.e. patients with a CR or PR.|Up to 45 months","Up to 45 months|PD (i.e. CR, PR, Stable Disease",{"$nulls":3},"Coffs Harbour, New South Wales, Australia, 2450 Northern Cancer InstituteSt Leonards, New South Wales, Australia, 2065 Macquarie University HospitalSydney, New South Wales, Australia, 2109 Riverina Cancer Care CentreWagga Wagga, New South Wales, Australia, 2650 Sydney Adventist HospitalWahroonga, New South Wales, Australia, 2076|Benowa, Queensland, Australia, 4217|Clayton, Victoria, Australia, 3168|Krems, Austria, 3500 Krankenhaus Der Barmherzigen BrÃ¼derWien, Austria, 1020 Allgemeines Krankenhaus Der Stadt WienWien, Austria, 1090 Wilhelminenspital Der Stadt WienWien, Austria, 1160|Linz, OberÃ¶sterreich, Austria, 4020|Graz, Steiermark, Austria, 8036|Gent, Belgium, 9000 Ch De Jolimont - Lobbes Site De JolimontLa Louviere, Belgium, 7100 Uz Leuven GasthuisbergLeuven, Belgium, 3000 Chu De LiÃ¨geLiege, Belgium, 4000 Clinique Saint-PierreOttignies, Belgium, 1340|Hamilton, Ontario, Canada, L8V 5C2 Princess Margaret Hospital-University Health NetworkToronto, Ontario, Canada, M5G 2M9|Ottawa, Canada, K1H 8L6|Montreal, Quebec, Canada, H3T 1E2|Beijing, China, 100050 Fifth Medical Center, General Hospital Of The Chinese PeopleBeijing, China, 100071 Peking University Third HospitalBeijing, China, 100191 Beijing HospitalBeijing, China, 100730 Peking Union Medical College Hospital CamsBeijing, China, 100730 Chongqing Cancer HospitalChongqing, China, 400030 First Affiliated Hospital Of Guangzhou Medical UniversityGuangzhou, China Fudan University Shanghai Cancer CenterShanghai, China, 200032 Zhongshan Hospital, Fudan UniversityShanghai, China, 200032 Huadong Hospital, Affiliated To Fudan UniversityShanghai, China, 200040 Tianjin Medical University Cancer Institiute & HospitalTianjin, China, 300060|Fuzhou, Fujian, China, 350001 The First Affiliated Hospital Of Xiamen UniversityXiamen, Fujian, China, 361003|Guangzhou, Guangdong, China, 510060|Shijiazhuang, Hebei, China, 050000|Chengdu, Sichuan, China, 610041 The First Hospital To AmuChongqing, Sichuan, China, 400038|Wuhan, Hubei, China, 430079|Changsha, Hunan, China, 410013|Nanjing, Jiangsu, China, 210008 Jiangsu Cancer HospitalNanjing, Jiangsu, China, 210009|Nanchang, Jiangxi, China, 330006|Changchun, Jilin, China, 130021|Shengyang, Liaoning, China, 110042|Taichung, Taiwan, 40447 Taichung Veterans General HospitalTaichung, Taiwan, 40705 National Cheng Kung University HospitalTainan, Taiwan National Taiwan University HospitalTaipei, Taiwan, 10002 Taipei Veterans General HospitalTaipei, Taiwan, 11217 Chang Gung Memorial Hospital At LinkouTaoyuan, Taiwan, 333|Xi'An, Shaanxi, China, 710061|Hangzhou, Zhejiang, China, 310014 The First Affiliated Hospital Of Wenzhou Medical UniversityWenzhou, Zhejiang, China, 325000|Ostrava, Czechia, 708 52 Fakultni Nemocnice Kralovske VinohradyPraha 10, Czechia, 10034 Fakultni Thomayerova NemocnicePraha 4 - Krc, Czechia, 140 59 Bata HospitalZlin, Czechia, 762 75|Aarhus N, Denmark, 8200 Herlev HospitalHerlev, Denmark, 2730 H:S RigshospitaletKÃ¸benhavn, Denmark, 2100|Helsinki, Finland, 00180 Tampereen Yliopistollinen Sairaala, KeskussairaalaTampere, Finland, Fin-33520|Besancon, France, 25030 HÃ´pital Saint AndrÃ© - BordeauxBordeaux, France, 33000 Centre De Lutte Contre Le Cancer FranÃ§ois BaclesseCaen Cedex 5, France, 14076 Centre Jean PerrinClermont Ferrand Cedex 1, France, 63011 Centre Oscar Lambret - LilleLille Cedex, France, 59020 Centre LÃ©on BÃ©rardLyon Cedex, France, 69008 Institut Paoli-Calmettes - MarseilleMarseille, France, 13273 HÃ´pital Saint LouisParis, France, 75010 Cochin - ParisParis, France, 75674 HÃ´pital D'Instruction Des ArmÃ©es BeginSaint Mande, France, 94160 Clinique Saint AnneStrasbourg, France, 67000 Centre MÃ©dico-Chirurgical FochSuresnes, France, 92151|Freiburg, Baden-WÃ¼rttemberg, Germany, 79106 Eberhard-Karls-UniversitÃ¤t TÃ¼bingenTÃ¼bingen, Baden-WÃ¼rttemberg, Germany, 72076 UniversitÃ¤tsklinikum UlmUlm, Baden-WÃ¼rttemberg, Germany, 89081|Erlangen, Bayern, Germany, 91054|DÃ¼sseldorf, Nordrhein-Westfalen, Germany, 40225|Mainz, Rheinland-Pfalz, Germany, 55131|Dresden, Sachsen, Germany, 01307|Berlin, Germany, 10967 Medizinische FakultÃ¤t Der Otto-Von-Guericke UniversitÃ¤tMagdeburg, Germany, 39120 Hong Kong Queen Mary HospitalHong Kong, Hong Kong Princess Margaret HospitalKowloon, Hong Kong Queen Elizabeth HospitalKowloon, Hong Kong Prince Of Wales HospitalShatin, Hong Kong|Budapest, Hungary, 1062 Bajcsy Zsilinszky Korhaz-RendelointezetBudapest, Hungary, 1106 Orszagos Onkologiai IntezetBudapest, Hungary, 1122 Debreceni Egyetem Klinikai KozpontDebrecen, Hungary, 4032 Pecsi Tudomanyegyetem Klinikai KozpontPecs, Hungary, 7624|Cork, Ireland AmnchDublin, Ireland, 24|Haifa, Israel, 3109601 Hadassah Hebrew University Hospital Ein KeremJerusalem, Israel, 9112001 Meir Medical CenterKfar Saba, Israel, 4428164 Rabin Medical Center - Beilinson CampusPetah Tikva, Israel, 4941492 Chaim Sheba Medical CenterRamat Gan, Israel, 5266202|ForlÃ¬-Cesena, Emilia-Romagna, Italy, 47014 Ausl ModenaModena, Emilia-Romagna, Italy, 41012 A.O.U. Di Modena - PoliclinicoModena, Emilia-Romagna, Italy, 41124|Roma, Lazio, Italy, 00152 Fondazione Policlinico Universitario Agostino GemelliRoma, Lazio, Italy, 00168|Milano, Lombardia, Italy, 20133 Irccs Istituto Europeo Di Oncologia (Ieo)Milano, Lombardia, Italy, 20141 Asst Grande Ospedale Metropolitano NiguardaMilano, Lombardia, Italy, 20162|Torino, Piemonte, Italy, 10043|Bari, Puglia, Italy, 70124|Pisa, Toscana, Italy, 56126|Verona, Veneto, Italy, 37134|Nagoya, Aichi, Japan, 466-8560|Akita, Japan, 010-8543 Kyushu University HospitalFukuoka, Japan, 812-8582 Hiroshima City Hiroshima Citizens HospitalHiroshima, Japan, 730-8518 Kumamoto University HospitalKumamoto, Japan, 860-8556 Niigata University Medical And Dental HospitalNiigata, Japan, 951-8520 Osaka International Cancer InstituteOsaka, Japan, 541-8567 Tokushima University HospitalTokushima, Japan, 770-8503 Toyama University HospitalToyama, Japan, 930-0194 Korea, Republic Of, Gyeonggido National Cancer CenterGoyang-Si, Gyeonggido, Korea, Republic Of, 410-769 Korea, Republic Of Asan Medical CenterSeoul, Korea, Republic Of, 05505 Samsung Medical CenterSeoul, Korea, Republic Of, 06351 Yonsei University College Of MedicineSeoul, Korea, Republic Of, 120-752|Hirosaki, Aomori, Japan, 036-8563|Matsuyama, Ehime, Japan, 791-0280|Maebashi, Gunma, Japan, 371-8511 Gunma Prefectural Cancer CenterOta, Gunma, Japan, 373-8550|Sapporo, Hokkaido, Japan, 060-8543 Hokkaido University HospitalSapporo, Hokkaido, Japan, 060-8648|Kobe, Hyogo, Japan, 650-0047|Tsukuba, Ibaraki, Japan, 305-8576|Morioka, Iwate, Japan, 020-8505|Yokohama, Kanagawa, Japan, 236-0004|Osakasayama, Osaka, Japan, 589-8511|Hidaka, Saitama, Japan, 350-1298|Bunkyo-Ku, Tokyo, Japan, 113-8603 National Cancer Center HospitalChuo-Ku, Tokyo, Japan, 104-0045 The Cancer Institute Hospital Of JfcrKoto-Ku, Tokyo, Japan, 135-8550 Keio University HospitalShinjuku-Ku, Tokyo, Japan, 160-8582|Amsterdam, Netherlands, 1066 Cx Erasmus Medisch CentrumRotterdam, Netherlands, 3075 Ea|Bydgoszcz, Poland, 85-796 Swietokrzyskie Centrum OnkologiiKielce, Poland, 25-734 Przychodnia Lekarska KomedKonin, Poland, 62-500 Salve Medica Sp. Z O.O. Sp.K.Lodz, Poland, 91-211 Samodzielny Publiczny Zespol Gruzlicy I Chorob PlucOlsztyn, Poland, 10-357 Szpital Kliniczny Przemienienia PanskiegoPoznan, Poland, 60-569 Uniwersytecki Szpital Kliniczny Im. J. Mikulicza-RadeckiegoWroclaw, Poland, 50-556|Coimbra, Portugal, 3000-075 Instituto PortuguÃªs De Oncologia Francisco Gentil - CoimbraCoimbra, Portugal, 3000-075 Hospital Cuf Infante SantoLisboa, Portugal, 1350-070 Centro Hospitalar De Lisboa Norte - Hospital Santa MariaLisboa, Portugal, 1649-035 Chup, Epe - Hospital De Santo AntonioPorto, Portugal, 4099-001 Russian Federation Krasnoyarsk Regional Clinical Oncology DispensaryKrasnoyarsk, Russian Federation, 660133 Moscow Scient. Res. Institute Of Oncology N.A P.A. HertzenMoscow, Russian Federation, 125284 Urological Center PomcNizhny Novgorod, Russian Federation, 603109 Clinical Oncological Dispensary Of Omsk RegionOmsk, Russian Federation, 644013 Samara Regional Clinical Oncology DispensarySamara, Russian Federation, 443031 Bashkir State Medical UniversityUfa, Russian Federation, 450008|Loures, Lisboa, Portugal, 2674-514|Bratislava, Slovakia, 833 10 Uroexam, Spol. S R.O.Nitra, Slovakia, 949 01 Poko Poprad S.R.O.Poprad, Slovakia, 085 01|CÃ³rdoba, AndalucÃ­a, Spain, 14004|Badalona, Barcelona, Spain, 08916 Institut CatalÃ  D'Oncologia HospitaletL'Hospitalet De Llobregat, Barcelona, Spain, 08907|Barcelona, Catalunya, Spain, 08003|Barcelona, Spain, 08035 Hospital San Pedro De AlcÃ¡ntaraCÃ¡ceres, Spain, 10003 Md Anderson International Espanya, S.A.Madrid, Spain, 28033 Hospital RamÃ³n Y CajalMadrid, Spain, 28034 Hospital Universitario 12 De OctubreMadrid, Spain, 28041 Hospital Virgen De La VictoriaMÃ¡laga, Spain, 29010 Instituto Valenciano De OncologÃ­aValencia, Spain, 46009 Hospital General Universitario De ValenciaValencia, Spain, 46014|Palma De Mallorca, Illes Baleares, Spain, 07120|Stockholm, Sweden, 118 83 Karolinska InstitutetStockholm, Sweden, 17167 Norrlands Universitetssjukhus, UmeÃ¥UmeÃ¥, Sweden, 901 85|Basel, Basel-Stadt, Switzerland, 4031|Chur, GraubÃ¼nden, Switzerland, 7000|Bern, Switzerland, 3010 UniversitÃ¤tsspital ZÃ¼richZÃ¼rich, Switzerland, 8091 Taiwan|St. Gallen, Sankt Gallen, Switzerland, 9007|Bebington, Merseyside, United Kingdom, Ch63 4Jy|Taunton, Somerset, United Kingdom, Ta1 5Da|London, United Kingdom, Sw3 6Jj|Anchorage, Alaska, United States, 99503|Phoenix, Arizona, United States, 85004 Arizona Oncology Associates, PcTucson, Arizona, United States, 85711 University Of Arizona Cancer CenterTucson, Arizona, United States, 85719|Los Angeles, California, United States, 90033 Uc Davis Comprehensive Cancer CenterSacramento, California, United States, 95817 Sansum ClinicSanta Barbara, California, United States, 93105|Littleton, Colorado, United States, 80120-4413|New Haven, Connecticut, United States, 06510|Orlando, Florida, United States, 32806|Chicago, Illinois, United States, 60611|Westwood, Kansas, United States, 66205|New Orleans, Louisiana, United States, 70112|Las Vegas, Nevada, United States, 89169|New York, New York, United States, 10016 Weill Cornell Medical CollegeNew York, New York, United States, 10065|Tigard, Oregon, United States, 97223|Pittsburgh, Pennsylvania, United States, 15232|Greenville, South Carolina, United States, 29607|Watertown, South Dakota, United States, 57201|Denton, Texas, United States, 76210 The Center For Cancer And Blood DisordersFort Worth, Texas, United States, 76104 Houston Methodist HospitalHouston, Texas, United States, 77030-2707|Seattle, Washington, United States, 98101 Summit Cancer CenterSpokane, Washington, United States, 99208","Alaska|Arizona|California|Colorado|Connecticut|Florida|Illinois|Kansas|Louisiana|Nevada|New York|Oregon|Pennsylvania|South Carolina|South Dakota|Texas|Washington","Australia|Austria|Belgium|Canada|China|Czechia|Denmark|Finland|France|Germany|Hungary|Ireland|Israel|Italy|Japan|Netherlands|Poland|Portugal|Slovakia|Spain|Sweden|Switzerland|United Kingdom|United States","New South Wales Mid North Coast Cancer Institute|Queensland Pindara Private Hospital|Victoria Monash Medical Centre|Landesklinikum Krems|OberÃ¶sterreich Krankenhaus Der Elisabethinen Linz Gmbh|Steiermark Medizinische UniversitÃ¤t Graz|Uz Gent|Ontario Juravinski Cancer Centre|Ottawa Hospital-General Campus|Quebec Sir Mortimer B. Davis Jewish General Hospital|Beijing Friendship Hospital, Capital Medical University|Fujian Fujian Medical University Union Hospital|Guangdong Sun Yat-Sen University Cancer Center|Hebei The 2Nd Hospital Of Hebei Medical University|Hospital, Sichuan University|Hubei Hubei Cancer Hospital|Hunan Hunan Cancer Hospital|Jiangsu Nj Drum Tower Hospital, The Affil Hos Of Nj Univ Med School|Jiangxi The First Affiliated Hospital Of Nanchang University|Jilin The First Hospital Of Jilin University|Liaoning Liaoning Cancer Hospital And Institute|Medical University Hospital|Shaanxi 1St Affiliated Hospital Of Xi'An Jiaotong Medical University|Zhejiang Zhejiang Provincial People's Hospital|Fakultni Nemocnice Ostrava|Aarhus Universitetshospital, Skejby|Docrates Klinikka|Hopital Jean Minjoz|Baden-WÃ¼rttemberg UniversitÃ¤tsklinikum Freiburg|Bayern UniversitÃ¤tsklinikum Erlangen|Nordrhein-Westfalen Heinrich-Heine-UniversitÃ¤t DÃ¼sseldorf|Rheinland-Pfalz UniversitÃ¤tsmedizin Der Johannes Gutenberg UniversitÃ¤t Mainz|Sachsen UniversitÃ¤tsklinikum Carl Gustav Carus Dresden|Vivantes Klinikum Am Urban|Mh Egeszsegugyi Kozpont|Cork University Hospital|Rambam Health Corporation|Emilia-Romagna Irst Istituto Scientifico Romagnolo Per Studio E Cura Tumori|Lazio A.O. San Camillo-Forlanini|Lombardia Fondazione Irccs Istituto Nazionale Dei Tumori|Piemonte A.O.U. San Luigi Gonzaga|Puglia Irccs Ist.Tumori Giovanni Paolo Ii - Osp. Oncologico Bari|Toscana A.O.U. Pisana|Veneto A.O.U. Integrata Verona|Aichi Nagoya University Hospital|Akita University Hospital|Aomori Hirosaki University Hospital|Ehime National Hospital Organization Shikoku Cancer Center|Gunma Gunma University Hospital|Hokkaido Sapporo Medical University Hospital|Hyogo Kobe City Medical Center General Hospital|Ibaraki University Of Tsukuba Hospital|Iwate Iwate Medical University Hospital|Kanagawa Yokohama City University Hospital|Osaka Kindai University Hospital|Saitama Saitama Medical University International Medical Center|Tokyo Nippon Medical School Hospital|Nederlands Kanker Instituut|Centrum Onkologii Im. Prof. Franciszka Lukaszczyka|Chuc - Hospitais Da Universidade De Coimbra|Lisboa Hospital Beatriz Angelo|Narodny Onkologicky Ustav|AndalucÃ­a Hospital Reina SofÃ­a|Barcelona Institut CatalÃ  D'Oncologia Badalona|Catalunya Hospital Del Mar|Ciutat SanitÃ ria I Universitaria De La Vall D'Hebron|Illes Baleares Hospital Universitari Son Espases|SÃ¶dersjukhuset|Basel-Stadt UniversitÃ¤tsspital Basel|GraubÃ¼nden Kantonsspital GraubÃ¼nden|Inselspital UniversitÃ¤tsspital Bern|Sankt Gallen Kantonsspital St. Gallen|, Merseyside Clatterbridge Centre For Oncology|, Somerset Musgrove Park Hospital|The Royal Marsden Hospital|Alaska Clinical Research Center, Llc|Univeristy Of Arizona Cancer Center|University Of Southern California|Rocky Mountain Cancer Centers|Yale Cancer Center|Uf Cancer Center At Orlando Health|Northwestern Medical Faculty Foundation Div Of Hem/Oncology|University Of Kansas Medical Center|Louisiana State University|Comprehensive Cancer Centers Of Nevada|Nyu Langone Medical Center|Compass Oncology|University Of Pittsburgh|Bon Secours St. Francis Hospital|Prairie Lakes Cancer Center|Texas Oncology-Denton South|Virginia Mason Medical Center",{"$nulls":3},"Bayer Study Director","2019-06-17","2020-05-25T16:38:41.554","2020-05-26T17:10:42.972","NCT03410693"]
["5ecbf492feab101b15530979","NCT03410693","2019-08-20","Bayer","BAYN","Active, not recruiting","Study of Rogaratinib (BAY1163877) vs Chemotherapy in Patients With FGFR (Fibroblast Growth Factor Receptor)-Positive Locally Advanced or Metastatic Urothelial Carcinoma (FORT-1)","Bay-1163877",null,"Yes","['Bay-1163877']","Unknown",null,"Phase 2/Phase 3",2,175,"Actual","2018-05-31","2022-04-25","OS","Overall Survival",{"$nulls":3},"This is a randomized, open-label, multicenter Phase 2/3 study to evaluate the efficacy and safety of rogaratinib (BAY 1163877) compared to chemotherapy in patients with FGFRpositive locally advanced or metastatic urothelial carcinoma who have received Prior platinum-containing chemotherapy.\n\nThe primary objective of the entire study is to compare rogaratinib (BAY1163877) with chemotherapy (docetaxel, paclitaxel or vinflunine) in terms of prolonging the Overall survival (OS) of patients with FGFR positive urothelial carcinoma.\n\nAt randomization, patients will have locally advanced or metastatic urothelial carcinoma and have received at least one prior platinum-containing chemotherapy regimen. Only patients with FGFR1 or 3 positive tumors can be randomized into the study. Archival tumor tissue is adequate for testing of FGFR1 and 3 mRNA expressions, which will be determined centrally using an RNA in situ hybridization (RNA-ISH) test. Approximately 42 % of UC patients with locally advanced or metastatic UC are identified as FGFR-positive by the RNA-ISH cut-off applied.",null,"A Randomized, Open Label, Multicenter Phase 2/3 Study to Evaluate the Efficacy and Safety of Rogaratinib (BAY1163877) Compared to Chemotherapy in Patients With FGFR-positive Locally Advanced or Metastatic Urothelial Carcinoma Who Have Received Prior Platinum-containing Chemotherapy",17403,"Carcinoma, Transitional Cell","Noma|Carcinoma|Transitional Cell Carcinoma","Mouth Diseases|Oncology Solid Tumor","Ear, Nose and Throat|Oncology","Experimental|Active Comparator","Rogaratinib|Chemotherapy",null,"Drug","Rogaratinib (BAY1163877)|Chemotherapy","Rogaratinib administered as oral (p.o.) tablets twice daily (b.i.d.) continuously|Chemotherapy as taxane (docetaxel or paclitaxel) or vinflunine administered through intravenous (i.v.) infusion every 3 weeks (on day 1 of a 21-day cycle) The choice of the chemotherapy is at the discretion of the investigator, taking into consideration the status of the authorization in the given Country (i.e. the drug has to be approved at least for one indication in the given country).",null,"Rogaratinib|Chemotherapy","\n\n * Existence of archival or fresh biopsy for FGFR testing\n * FGFR testing of patients will be performed at the investigators' discretion up to a max. of 90 days prior to start of screening.\n\nInvestigators should ensure all patients will be eligible in terms of disease status and lines of treatment within this timeframe.\n\n * Documented urothelial carcinoma (transitional cell carcinoma) including urinary bladder, renal pelvis, ureters, urethra meeting all of the following criteria * Histologically or cytologically confirmed (patients with mixed histologies are required to have a dominant transitional cell pattern.)\n    * Locally advanced (T4b, any N; or any T, N 2âˆ’3) or metastatic disease (any T, any N and M1). Locally advanced bladder cancer must be unresectable i.e. invading the pelvic or abdominal wall (stage T4b) or presenting with bulky nodal disease (N2-3).\n   \n   \n * ECOG (Eastern Cooperative Oncology Group) Performance Status of 0 or 1\n * Disease progression during or following treatment with at least one platinum-containing regimen (patients should have been treated for at least 2 cycles). In patients who received prior adjuvant/ neoadjuvant platinum-containing chemotherapy, progression had to occur within 12 months of treatment.\n * High FGFR1 or 3 mRNA (Messenger ribonucleic acid) expression levels (RNAscope score of 3+ or 4+; measurement is part of this protocol) in archival or fresh Tumor biopsy specimen\n * At least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST v.1.1) in contrast enhanced (unless contraindicated) CT or MRI\n\n","\n\n * Previous or concurrent cancer except * cervical carcinoma in situ\n    * treated basal-cell or squamous cell skin carcinoma\n    * any cancer curatively treated > 3 years before randomization\n    * curatively treated incidental prostate cancer (T1/T2a)\n   \n   \n * Ongoing or previous anti-cancer treatment within 4 weeks before randomization.\n * More than two prior lines of systemic anti-cancer therapy for urothelial carcinoma\n * Ongoing or previous treatment with anti-FGFR directed therapies (e.g. receptor tyrosine kinase inhibitors including rogaratinib or FGFRspecific antibodies) or with taxanes or vinflunine\n * Unresolved toxicity higher than National Cancer Institute's Common Terminology Criteria for Adverse Events, version 4.03 (CTCAE v.4.03) Grade 1 attributed to any prior therapy/ procedure excluding alopecia, anemia and/ or hypothyroidism\n * History or current condition of an uncontrolled cardiovascular disease including any of the following conditions: * Congestive heart failure (CHF) NYHA (New York Heart Association) > Class 2\n    * Unstable angina (symptoms of angina at rest) or new-onset angina (within last 3 months before randomization)\n    * Myocardial infarction (MI) within past 6 months before randomization\n    * Unstable cardiac arrhythmias requiring anti-arrhythmic therapy. Patients with arrhythmia under control with anti-arrhythmic therapy such as beta-blockers or digoxin are eligible.\n   \n   \n * Arterial or venous thrombotic events or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within 3 months before randomization\n * Current evidence of endocrine alteration of calcium phosphate homeostasis (e.g. parathyroid disorder, history of parathyroidectomy, tumor lysis, tumoral calcinosis, paraneoplastic hypercalcemia)\n * Any hemorrhage / bleeding event â‰¥ CTCAE v.4.03 Grade 3 within 4 weeks before randomization\n * Current diagnosis of any retinal detachment, retinal pigment epithelial detachment (RPED), serous retinopathy or retinal vein occlusion",{"$nulls":4},"Actual","2018-01-25","Actual","Anticipated","2022-04-25","Anticipated","2019-08-01","2018-01-19","2018-01-19","2019-08-19","Yes","Urothelial carcinoma","Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"2016-004340-11","EudraCT Number","Overall Survival","Defined as the time (days) from randomization to death due to any cause. Patients alive at the date of data cut-off for analysis will be censored at the last date known to be alive.","Up to 45 months","Progression-free survival (PFS)|Objective response rate (ORR)|Disease-control rate (DCR)|Duration of response (DOR)|Incidence of Adverse Events as a measure of safety and tolerability","Defined as the time (days) from randomization to date of first observed disease progression (radiological or clinical assessment) or death due to any cause, if death occurs before progression is documented. For patients without documented radiological or clinical progression or death at the time of analysis, PFS will be censored at the last actual visit date of tumor evaluation.|Defined as the percentage of patients with complete response (CR) or partial Response (PR). Patients for whom overall best response is not CR or PR, as well as patients without any post-baseline tumor assessment will be considered non-responders.|Defined as the percentage of patients, whose overall best response was not progressive disease|Defined as the time from the first documented objective response of PR or CR, whichever is noted earlier, to disease progression or death (if death occurs before progression is documented). DOR will be defined for responders only, i.e. patients with a CR or PR.|Up to 45 months","Up to 45 months|PD (i.e. CR, PR, Stable Disease",{"$nulls":3},"Coffs Harbour, New South Wales, Australia, 2450 Northern Cancer InstituteSt Leonards, New South Wales, Australia, 2065 Macquarie University HospitalSydney, New South Wales, Australia, 2109 Riverina Cancer Care CentreWagga Wagga, New South Wales, Australia, 2650 Sydney Adventist HospitalWahroonga, New South Wales, Australia, 2076|Benowa, Queensland, Australia, 4217|Clayton, Victoria, Australia, 3168|Krems, Austria, 3500 Krankenhaus Der Barmherzigen BrÃ¼derWien, Austria, 1020 Allgemeines Krankenhaus Der Stadt WienWien, Austria, 1090 Wilhelminenspital Der Stadt WienWien, Austria, 1160|Linz, OberÃ¶sterreich, Austria, 4020|Graz, Steiermark, Austria, 8036|Gent, Belgium, 9000 Ch De Jolimont - Lobbes Site De JolimontLa Louviere, Belgium, 7100 Uz Leuven GasthuisbergLeuven, Belgium, 3000 Chu De LiÃ¨geLiege, Belgium, 4000 Clinique Saint-PierreOttignies, Belgium, 1340|Hamilton, Ontario, Canada, L8V 5C2 Princess Margaret Hospital-University Health NetworkToronto, Ontario, Canada, M5G 2M9|Ottawa, Canada, K1H 8L6|Montreal, Quebec, Canada, H3T 1E2|Beijing, China, 100050 Fifth Medical Center, General Hospital Of The Chinese PeopleBeijing, China, 100071 Peking University Third HospitalBeijing, China, 100191 Beijing HospitalBeijing, China, 100730 Peking Union Medical College Hospital CamsBeijing, China, 100730 Chongqing Cancer HospitalChongqing, China, 400030 First Affiliated Hospital Of Guangzhou Medical UniversityGuangzhou, China Fudan University Shanghai Cancer CenterShanghai, China, 200032 Zhongshan Hospital, Fudan UniversityShanghai, China, 200032 Huadong Hospital, Affiliated To Fudan UniversityShanghai, China, 200040 Tianjin Medical University Cancer Institiute & HospitalTianjin, China, 300060|Fuzhou, Fujian, China, 350001 The First Affiliated Hospital Of Xiamen UniversityXiamen, Fujian, China, 361003|Guangzhou, Guangdong, China, 510060|Shijiazhuang, Hebei, China, 050000|Chengdu, Sichuan, China, 610041 The First Hospital To AmuChongqing, Sichuan, China, 400038|Wuhan, Hubei, China, 430079|Changsha, Hunan, China, 410013|Nanjing, Jiangsu, China, 210008 Jiangsu Cancer HospitalNanjing, Jiangsu, China, 210009|Nanchang, Jiangxi, China, 330006|Changchun, Jilin, China, 130021|Shengyang, Liaoning, China, 110042|Taichung, Taiwan, 40447 Taichung Veterans General HospitalTaichung, Taiwan, 40705 National Cheng Kung University HospitalTainan, Taiwan National Taiwan University HospitalTaipei, Taiwan, 10002 Taipei Veterans General HospitalTaipei, Taiwan, 11217 Chang Gung Memorial Hospital At LinkouTaoyuan, Taiwan, 333|Xi'An, Shaanxi, China, 710061|Hangzhou, Zhejiang, China, 310014 The First Affiliated Hospital Of Wenzhou Medical UniversityWenzhou, Zhejiang, China, 325000|Ostrava, Czechia, 708 52 Fakultni Nemocnice Kralovske VinohradyPraha 10, Czechia, 10034 Fakultni Thomayerova NemocnicePraha 4 - Krc, Czechia, 140 59 Bata HospitalZlin, Czechia, 762 75|Aarhus N, Denmark, 8200 Herlev HospitalHerlev, Denmark, 2730 H:S RigshospitaletKÃ¸benhavn, Denmark, 2100|Helsinki, Finland, 00180 Tampereen Yliopistollinen Sairaala, KeskussairaalaTampere, Finland, Fin-33520|Besancon, France, 25030 HÃ´pital Saint AndrÃ© - BordeauxBordeaux, France, 33000 Centre De Lutte Contre Le Cancer FranÃ§ois BaclesseCaen Cedex 5, France, 14076 Centre Jean PerrinClermont Ferrand Cedex 1, France, 63011 Centre Oscar Lambret - LilleLille Cedex, France, 59020 Centre LÃ©on BÃ©rardLyon Cedex, France, 69008 Institut Paoli-Calmettes - MarseilleMarseille, France, 13273 HÃ´pital Saint LouisParis, France, 75010 Cochin - ParisParis, France, 75674 HÃ´pital D'Instruction Des ArmÃ©es BeginSaint Mande, France, 94160 Clinique Saint AnneStrasbourg, France, 67000 Centre MÃ©dico-Chirurgical FochSuresnes, France, 92151|Freiburg, Baden-WÃ¼rttemberg, Germany, 79106 Eberhard-Karls-UniversitÃ¤t TÃ¼bingenTÃ¼bingen, Baden-WÃ¼rttemberg, Germany, 72076 UniversitÃ¤tsklinikum UlmUlm, Baden-WÃ¼rttemberg, Germany, 89081|Erlangen, Bayern, Germany, 91054|DÃ¼sseldorf, Nordrhein-Westfalen, Germany, 40225|Mainz, Rheinland-Pfalz, Germany, 55131|Dresden, Sachsen, Germany, 01307|Berlin, Germany, 10967 Medizinische FakultÃ¤t Der Otto-Von-Guericke UniversitÃ¤tMagdeburg, Germany, 39120 Hong Kong Queen Mary HospitalHong Kong, Hong Kong Princess Margaret HospitalKowloon, Hong Kong Queen Elizabeth HospitalKowloon, Hong Kong Prince Of Wales HospitalShatin, Hong Kong|Budapest, Hungary, 1062 Bajcsy Zsilinszky Korhaz-RendelointezetBudapest, Hungary, 1106 Orszagos Onkologiai IntezetBudapest, Hungary, 1122 Debreceni Egyetem Klinikai KozpontDebrecen, Hungary, 4032 Pecsi Tudomanyegyetem Klinikai KozpontPecs, Hungary, 7624|Cork, Ireland AmnchDublin, Ireland, 24|Haifa, Israel, 3109601 Hadassah Hebrew University Hospital Ein KeremJerusalem, Israel, 9112001 Meir Medical CenterKfar Saba, Israel, 4428164 Rabin Medical Center - Beilinson CampusPetah Tikva, Israel, 4941492 Chaim Sheba Medical CenterRamat Gan, Israel, 5266202|ForlÃ¬-Cesena, Emilia-Romagna, Italy, 47014 Ausl ModenaModena, Emilia-Romagna, Italy, 41012 A.O.U. Di Modena - PoliclinicoModena, Emilia-Romagna, Italy, 41124|Roma, Lazio, Italy, 00152 Fondazione Policlinico Universitario Agostino GemelliRoma, Lazio, Italy, 00168|Milano, Lombardia, Italy, 20133 Irccs Istituto Europeo Di Oncologia (Ieo)Milano, Lombardia, Italy, 20141 Asst Grande Ospedale Metropolitano NiguardaMilano, Lombardia, Italy, 20162|Torino, Piemonte, Italy, 10043|Bari, Puglia, Italy, 70124|Pisa, Toscana, Italy, 56126|Verona, Veneto, Italy, 37134|Nagoya, Aichi, Japan, 466-8560|Akita, Japan, 010-8543 Kyushu University HospitalFukuoka, Japan, 812-8582 Hiroshima City Hiroshima Citizens HospitalHiroshima, Japan, 730-8518 Kumamoto University HospitalKumamoto, Japan, 860-8556 Niigata University Medical And Dental HospitalNiigata, Japan, 951-8520 Osaka International Cancer InstituteOsaka, Japan, 541-8567 Tokushima University HospitalTokushima, Japan, 770-8503 Toyama University HospitalToyama, Japan, 930-0194 Korea, Republic Of, Gyeonggido National Cancer CenterGoyang-Si, Gyeonggido, Korea, Republic Of, 410-769 Korea, Republic Of Asan Medical CenterSeoul, Korea, Republic Of, 05505 Samsung Medical CenterSeoul, Korea, Republic Of, 06351 Yonsei University College Of MedicineSeoul, Korea, Republic Of, 120-752|Hirosaki, Aomori, Japan, 036-8563|Matsuyama, Ehime, Japan, 791-0280|Maebashi, Gunma, Japan, 371-8511 Gunma Prefectural Cancer CenterOta, Gunma, Japan, 373-8550|Sapporo, Hokkaido, Japan, 060-8543 Hokkaido University HospitalSapporo, Hokkaido, Japan, 060-8648|Kobe, Hyogo, Japan, 650-0047|Tsukuba, Ibaraki, Japan, 305-8576|Morioka, Iwate, Japan, 020-8505|Yokohama, Kanagawa, Japan, 236-0004|Osakasayama, Osaka, Japan, 589-8511|Hidaka, Saitama, Japan, 350-1298|Bunkyo-Ku, Tokyo, Japan, 113-8603 National Cancer Center HospitalChuo-Ku, Tokyo, Japan, 104-0045 The Cancer Institute Hospital Of JfcrKoto-Ku, Tokyo, Japan, 135-8550 Keio University HospitalShinjuku-Ku, Tokyo, Japan, 160-8582|Amsterdam, Netherlands, 1066 Cx Erasmus Medisch CentrumRotterdam, Netherlands, 3075 Ea|Bydgoszcz, Poland, 85-796 Swietokrzyskie Centrum OnkologiiKielce, Poland, 25-734 Przychodnia Lekarska KomedKonin, Poland, 62-500 Salve Medica Sp. Z O.O. Sp.K.Lodz, Poland, 91-211 Samodzielny Publiczny Zespol Gruzlicy I Chorob PlucOlsztyn, Poland, 10-357 Szpital Kliniczny Przemienienia PanskiegoPoznan, Poland, 60-569 Uniwersytecki Szpital Kliniczny Im. J. Mikulicza-RadeckiegoWroclaw, Poland, 50-556|Coimbra, Portugal, 3000-075 Instituto PortuguÃªs De Oncologia Francisco Gentil - CoimbraCoimbra, Portugal, 3000-075 Hospital Cuf Infante SantoLisboa, Portugal, 1350-070 Centro Hospitalar De Lisboa Norte - Hospital Santa MariaLisboa, Portugal, 1649-035 Chup, Epe - Hospital De Santo AntonioPorto, Portugal, 4099-001 Russian Federation Krasnoyarsk Regional Clinical Oncology DispensaryKrasnoyarsk, Russian Federation, 660133 Moscow Scient. Res. Institute Of Oncology N.A P.A. HertzenMoscow, Russian Federation, 125284 Urological Center PomcNizhny Novgorod, Russian Federation, 603109 Clinical Oncological Dispensary Of Omsk RegionOmsk, Russian Federation, 644013 Samara Regional Clinical Oncology DispensarySamara, Russian Federation, 443031 Bashkir State Medical UniversityUfa, Russian Federation, 450008|Loures, Lisboa, Portugal, 2674-514|Bratislava, Slovakia, 833 10 Uroexam, Spol. S R.O.Nitra, Slovakia, 949 01 Poko Poprad S.R.O.Poprad, Slovakia, 085 01|CÃ³rdoba, AndalucÃ­a, Spain, 14004|Badalona, Barcelona, Spain, 08916 Institut CatalÃ  D'Oncologia HospitaletL'Hospitalet De Llobregat, Barcelona, Spain, 08907|Barcelona, Catalunya, Spain, 08003|Barcelona, Spain, 08035 Hospital San Pedro De AlcÃ¡ntaraCÃ¡ceres, Spain, 10003 Md Anderson International Espanya, S.A.Madrid, Spain, 28033 Hospital RamÃ³n Y CajalMadrid, Spain, 28034 Hospital Universitario 12 De OctubreMadrid, Spain, 28041 Hospital Virgen De La VictoriaMÃ¡laga, Spain, 29010 Instituto Valenciano De OncologÃ­aValencia, Spain, 46009 Hospital General Universitario De ValenciaValencia, Spain, 46014|Palma De Mallorca, Illes Baleares, Spain, 07120|Stockholm, Sweden, 118 83 Karolinska InstitutetStockholm, Sweden, 17167 Norrlands Universitetssjukhus, UmeÃ¥UmeÃ¥, Sweden, 901 85|Basel, Basel-Stadt, Switzerland, 4031|Chur, GraubÃ¼nden, Switzerland, 7000|Bern, Switzerland, 3010 UniversitÃ¤tsspital ZÃ¼richZÃ¼rich, Switzerland, 8091 Taiwan|St. Gallen, Sankt Gallen, Switzerland, 9007|Bebington, Merseyside, United Kingdom, Ch63 4Jy|Taunton, Somerset, United Kingdom, Ta1 5Da|London, United Kingdom, Sw3 6Jj|Anchorage, Alaska, United States, 99503|Phoenix, Arizona, United States, 85004 Arizona Oncology Associates, PcTucson, Arizona, United States, 85711 University Of Arizona Cancer CenterTucson, Arizona, United States, 85719|Los Angeles, California, United States, 90033 Uc Davis Comprehensive Cancer CenterSacramento, California, United States, 95817 Sansum ClinicSanta Barbara, California, United States, 93105|Littleton, Colorado, United States, 80120-4413|New Haven, Connecticut, United States, 06510|Orlando, Florida, United States, 32806 Woodlands Medical Specialists, PaPensacola, Florida, United States, 32503|Chicago, Illinois, United States, 60611|Westwood, Kansas, United States, 66205|New Orleans, Louisiana, United States, 70112|Las Vegas, Nevada, United States, 89169|New York, New York, United States, 10016 Weill Cornell Medical CollegeNew York, New York, United States, 10065|Tigard, Oregon, United States, 97223|Pittsburgh, Pennsylvania, United States, 15232|Greenville, South Carolina, United States, 29607|Watertown, South Dakota, United States, 57201|Denton, Texas, United States, 76210 The Center For Cancer And Blood DisordersFort Worth, Texas, United States, 76104 Houston Methodist HospitalHouston, Texas, United States, 77030-2707|Seattle, Washington, United States, 98101 Summit Cancer CenterSpokane, Washington, United States, 99208","Alaska|Arizona|California|Colorado|Connecticut|Florida|Illinois|Kansas|Louisiana|Nevada|New York|Oregon|Pennsylvania|South Carolina|South Dakota|Texas|Washington","Australia|Austria|Belgium|Canada|China|Czechia|Denmark|Finland|France|Germany|Hungary|Ireland|Israel|Italy|Japan|Netherlands|Poland|Portugal|Slovakia|Spain|Sweden|Switzerland|United Kingdom|United States","New South Wales Mid North Coast Cancer Institute|Queensland Pindara Private Hospital|Victoria Monash Medical Centre|Landesklinikum Krems|OberÃ¶sterreich Krankenhaus Der Elisabethinen Linz Gmbh|Steiermark Medizinische UniversitÃ¤t Graz|Uz Gent|Ontario Juravinski Cancer Centre|Ottawa Hospital-General Campus|Quebec Sir Mortimer B. Davis Jewish General Hospital|Beijing Friendship Hospital, Capital Medical University|Fujian Fujian Medical University Union Hospital|Guangdong Sun Yat-Sen University Cancer Center|Hebei The 2Nd Hospital Of Hebei Medical University|Hospital, Sichuan University|Hubei Hubei Cancer Hospital|Hunan Hunan Cancer Hospital|Jiangsu Nj Drum Tower Hospital, The Affil Hos Of Nj Univ Med School|Jiangxi The First Affiliated Hospital Of Nanchang University|Jilin The First Hospital Of Jilin University|Liaoning Liaoning Cancer Hospital And Institute|Medical University Hospital|Shaanxi 1St Affiliated Hospital Of Xi'An Jiaotong Medical University|Zhejiang Zhejiang Provincial People's Hospital|Fakultni Nemocnice Ostrava|Aarhus Universitetshospital, Skejby|Docrates Klinikka|Hopital Jean Minjoz|Baden-WÃ¼rttemberg UniversitÃ¤tsklinikum Freiburg|Bayern UniversitÃ¤tsklinikum Erlangen|Nordrhein-Westfalen Heinrich-Heine-UniversitÃ¤t DÃ¼sseldorf|Rheinland-Pfalz UniversitÃ¤tsmedizin Der Johannes Gutenberg UniversitÃ¤t Mainz|Sachsen UniversitÃ¤tsklinikum Carl Gustav Carus Dresden|Vivantes Klinikum Am Urban|Mh Egeszsegugyi Kozpont|Cork University Hospital|Rambam Health Corporation|Emilia-Romagna Irst Istituto Scientifico Romagnolo Per Studio E Cura Tumori|Lazio A.O. San Camillo-Forlanini|Lombardia Fondazione Irccs Istituto Nazionale Dei Tumori|Piemonte A.O.U. San Luigi Gonzaga|Puglia Irccs Ist.Tumori Giovanni Paolo Ii - Osp. Oncologico Bari|Toscana A.O.U. Pisana|Veneto A.O.U. Integrata Verona|Aichi Nagoya University Hospital|Akita University Hospital|Aomori Hirosaki University Hospital|Ehime National Hospital Organization Shikoku Cancer Center|Gunma Gunma University Hospital|Hokkaido Sapporo Medical University Hospital|Hyogo Kobe City Medical Center General Hospital|Ibaraki University Of Tsukuba Hospital|Iwate Iwate Medical University Hospital|Kanagawa Yokohama City University Hospital|Osaka Kindai University Hospital|Saitama Saitama Medical University International Medical Center|Tokyo Nippon Medical School Hospital|Nederlands Kanker Instituut|Centrum Onkologii Im. Prof. Franciszka Lukaszczyka|Chuc - Hospitais Da Universidade De Coimbra|Lisboa Hospital Beatriz Angelo|Narodny Onkologicky Ustav|AndalucÃ­a Hospital Reina SofÃ­a|Barcelona Institut CatalÃ  D'Oncologia Badalona|Catalunya Hospital Del Mar|Ciutat SanitÃ ria I Universitaria De La Vall D'Hebron|Illes Baleares Hospital Universitari Son Espases|SÃ¶dersjukhuset|Basel-Stadt UniversitÃ¤tsspital Basel|GraubÃ¼nden Kantonsspital GraubÃ¼nden|Inselspital UniversitÃ¤tsspital Bern|Sankt Gallen Kantonsspital St. Gallen|, Merseyside Clatterbridge Centre For Oncology|, Somerset Musgrove Park Hospital|The Royal Marsden Hospital|Alaska Clinical Research Center, Llc|Univeristy Of Arizona Cancer Center|University Of Southern California|Rocky Mountain Cancer Centers|Yale Cancer Center|Uf Cancer Center At Orlando Health|Northwestern Medical Faculty Foundation Div Of Hem/Oncology|University Of Kansas Medical Center|Louisiana State University|Comprehensive Cancer Centers Of Nevada|Nyu Langone Medical Center|Compass Oncology|University Of Pittsburgh|Bon Secours St. Francis Hospital|Prairie Lakes Cancer Center|Texas Oncology-Denton South|Virginia Mason Medical Center",{"$nulls":3},"Bayer Study Director","2019-08-19","2020-05-25T16:38:42.134","2020-05-26T17:10:42.972","NCT03410693"]
["5ecbf492307e3d1b1f8d9ddb","NCT03410693","2019-09-23","Bayer","BAYN","Active, not recruiting","Study of Rogaratinib (BAY1163877) vs Chemotherapy in Patients With FGFR (Fibroblast Growth Factor Receptor)-Positive Locally Advanced or Metastatic Urothelial Carcinoma (FORT-1)","Bay-1163877",null,"Yes","['Bay-1163877']","Unknown",null,"Phase 2/Phase 3",2,175,"Actual","2018-05-31","2022-04-25","OS","Overall Survival",{"$nulls":3},"This is a randomized, open-label, multicenter Phase 2/3 study to evaluate the efficacy and safety of rogaratinib (BAY 1163877) compared to chemotherapy in patients with FGFRpositive locally advanced or metastatic urothelial carcinoma who have received Prior platinum-containing chemotherapy.\n\nThe primary objective of the entire study is to compare rogaratinib (BAY1163877) with chemotherapy (docetaxel, paclitaxel or vinflunine) in terms of prolonging the Overall survival (OS) of patients with FGFR positive urothelial carcinoma.\n\nAt randomization, patients will have locally advanced or metastatic urothelial carcinoma and have received at least one prior platinum-containing chemotherapy regimen. Only patients with FGFR1 or 3 positive tumors can be randomized into the study. Archival tumor tissue is adequate for testing of FGFR1 and 3 mRNA expressions, which will be determined centrally using an RNA in situ hybridization (RNA-ISH) test. Approximately 42 % of UC patients with locally advanced or metastatic UC are identified as FGFR-positive by the RNA-ISH cut-off applied.",null,"A Randomized, Open Label, Multicenter Phase 2/3 Study to Evaluate the Efficacy and Safety of Rogaratinib (BAY1163877) Compared to Chemotherapy in Patients With FGFR-positive Locally Advanced or Metastatic Urothelial Carcinoma Who Have Received Prior Platinum-containing Chemotherapy",17403,"Carcinoma, Transitional Cell","Noma|Carcinoma|Transitional Cell Carcinoma","Mouth Diseases|Oncology Solid Tumor","Ear, Nose and Throat|Oncology","Experimental|Active Comparator","Rogaratinib|Chemotherapy",null,"Drug","Rogaratinib (BAY1163877)|Chemotherapy","Rogaratinib administered as oral (p.o.) tablets twice daily (b.i.d.) continuously|Chemotherapy as taxane (docetaxel or paclitaxel) or vinflunine administered through intravenous (i.v.) infusion every 3 weeks (on day 1 of a 21-day cycle) The choice of the chemotherapy is at the discretion of the investigator, taking into consideration the status of the authorization in the given Country (i.e. the drug has to be approved at least for one indication in the given country).",null,"Rogaratinib|Chemotherapy","\n\n * Existence of archival or fresh biopsy for FGFR testing\n * FGFR testing of patients will be performed at the investigators' discretion up to a max. of 90 days prior to start of screening.\n\nInvestigators should ensure all patients will be eligible in terms of disease status and lines of treatment within this timeframe.\n\n * Documented urothelial carcinoma (transitional cell carcinoma) including urinary bladder, renal pelvis, ureters, urethra meeting all of the following criteria * Histologically or cytologically confirmed (patients with mixed histologies are required to have a dominant transitional cell pattern.)\n    * Locally advanced (T4b, any N; or any T, N 2âˆ’3) or metastatic disease (any T, any N and M1). Locally advanced bladder cancer must be unresectable i.e. invading the pelvic or abdominal wall (stage T4b) or presenting with bulky nodal disease (N2-3).\n   \n   \n * ECOG (Eastern Cooperative Oncology Group) Performance Status of 0 or 1\n * Disease progression during or following treatment with at least one platinum-containing regimen (patients should have been treated for at least 2 cycles). In patients who received prior adjuvant/ neoadjuvant platinum-containing chemotherapy, progression had to occur within 12 months of treatment.\n * High FGFR1 or 3 mRNA (Messenger ribonucleic acid) expression levels (RNAscope score of 3+ or 4+; measurement is part of this protocol) in archival or fresh Tumor biopsy specimen\n * At least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST v.1.1) in contrast enhanced (unless contraindicated) CT or MRI\n\n","\n\n * Previous or concurrent cancer except * cervical carcinoma in situ\n    * treated basal-cell or squamous cell skin carcinoma\n    * any cancer curatively treated > 3 years before randomization\n    * curatively treated incidental prostate cancer (T1/T2a)\n   \n   \n * Ongoing or previous anti-cancer treatment within 4 weeks before randomization.\n * More than two prior lines of systemic anti-cancer therapy for urothelial carcinoma\n * Ongoing or previous treatment with anti-FGFR directed therapies (e.g. receptor tyrosine kinase inhibitors including rogaratinib or FGFRspecific antibodies) or with taxanes or vinflunine\n * Unresolved toxicity higher than National Cancer Institute's Common Terminology Criteria for Adverse Events, version 4.03 (CTCAE v.4.03) Grade 1 attributed to any prior therapy/ procedure excluding alopecia, anemia and/ or hypothyroidism\n * History or current condition of an uncontrolled cardiovascular disease including any of the following conditions: * Congestive heart failure (CHF) NYHA (New York Heart Association) > Class 2\n    * Unstable angina (symptoms of angina at rest) or new-onset angina (within last 3 months before randomization)\n    * Myocardial infarction (MI) within past 6 months before randomization\n    * Unstable cardiac arrhythmias requiring anti-arrhythmic therapy. Patients with arrhythmia under control with anti-arrhythmic therapy such as beta-blockers or digoxin are eligible.\n   \n   \n * Arterial or venous thrombotic events or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within 3 months before randomization\n * Current evidence of endocrine alteration of calcium phosphate homeostasis (e.g. parathyroid disorder, history of parathyroidectomy, tumor lysis, tumoral calcinosis, paraneoplastic hypercalcemia)\n * Any hemorrhage / bleeding event â‰¥ CTCAE v.4.03 Grade 3 within 4 weeks before randomization\n * Current diagnosis of any retinal detachment, retinal pigment epithelial detachment (RPED), serous retinopathy or retinal vein occlusion",{"$nulls":4},"Actual","2018-01-25","Actual","Anticipated","2022-04-25","Anticipated","2019-09-01","2018-01-19","2018-01-19","2019-09-20","Yes","Urothelial carcinoma","Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"2016-004340-11","EudraCT Number","Overall Survival","Defined as the time (days) from randomization to death due to any cause. Patients alive at the date of data cut-off for analysis will be censored at the last date known to be alive.","Up to 45 months","Progression-free survival (PFS)|Objective response rate (ORR)|Disease-control rate (DCR)|Duration of response (DOR)|Incidence of Adverse Events as a measure of safety and tolerability","Defined as the time (days) from randomization to date of first observed disease progression (radiological or clinical assessment) or death due to any cause, if death occurs before progression is documented. For patients without documented radiological or clinical progression or death at the time of analysis, PFS will be censored at the last actual visit date of tumor evaluation.|Defined as the percentage of patients with complete response (CR) or partial Response (PR). Patients for whom overall best response is not CR or PR, as well as patients without any post-baseline tumor assessment will be considered non-responders.|Defined as the percentage of patients, whose overall best response was not progressive disease|Defined as the time from the first documented objective response of PR or CR, whichever is noted earlier, to disease progression or death (if death occurs before progression is documented). DOR will be defined for responders only, i.e. patients with a CR or PR.|Up to 45 months","Up to 45 months|PD (i.e. CR, PR, Stable Disease",{"$nulls":3},"Coffs Harbour, New South Wales, Australia, 2450 Northern Cancer InstituteSt Leonards, New South Wales, Australia, 2065 Macquarie University HospitalSydney, New South Wales, Australia, 2109 Riverina Cancer Care CentreWagga Wagga, New South Wales, Australia, 2650 Sydney Adventist HospitalWahroonga, New South Wales, Australia, 2076|Benowa, Queensland, Australia, 4217|Clayton, Victoria, Australia, 3168|Krems, Austria, 3500 Krankenhaus Der Barmherzigen BrÃ¼derWien, Austria, 1020 Allgemeines Krankenhaus Der Stadt WienWien, Austria, 1090 Wilhelminenspital Der Stadt WienWien, Austria, 1160|Gent, Belgium, 9000 Ch De Jolimont - Lobbes Site De JolimontLa Louviere, Belgium, 7100 Uz Leuven GasthuisbergLeuven, Belgium, 3000 Chu De LiÃ¨geLiege, Belgium, 4000 Clinique Saint-PierreOttignies, Belgium, 1340|Toronto, Ontario, Canada, M5G 2M9|Ottawa, Canada, K1H 8L6|Montreal, Quebec, Canada, H3T 1E2|Beijing, China, 100050 Fifth Medical Center, General Hospital Of The Chinese PeopleBeijing, China, 100071 Peking University Third HospitalBeijing, China, 100191 Beijing HospitalBeijing, China, 100730 Peking Union Medical College Hospital CamsBeijing, China, 100730 Chongqing Cancer HospitalChongqing, China, 400030 First Affiliated Hospital Of Guangzhou Medical UniversityGuangzhou, China Fudan University Shanghai Cancer CenterShanghai, China, 200032 Zhongshan Hospital, Fudan UniversityShanghai, China, 200032 Huadong Hospital, Affiliated To Fudan UniversityShanghai, China, 200040 Tianjin Medical University Cancer Institiute & HospitalTianjin, China, 300060|Fuzhou, Fujian, China, 350001 The First Affiliated Hospital Of Xiamen UniversityXiamen, Fujian, China, 361003|Guangzhou, Guangdong, China, 510060|Shijiazhuang, Hebei, China, 050000|Chengdu, Sichuan, China, 610041 The First Hospital To AmuChongqing, Sichuan, China, 400038|Wuhan, Hubei, China, 430079|Changsha, Hunan, China, 410013|Nanjing, Jiangsu, China, 210008 Jiangsu Cancer HospitalNanjing, Jiangsu, China, 210009|Nanchang, Jiangxi, China, 330006|Changchun, Jilin, China, 130021|Shengyang, Liaoning, China, 110042|Taichung, Taiwan, 40447 Taichung Veterans General HospitalTaichung, Taiwan, 40705 National Cheng Kung University HospitalTainan, Taiwan National Taiwan University HospitalTaipei, Taiwan, 10002 Taipei Veterans General HospitalTaipei, Taiwan, 11217 Chang Gung Memorial Hospital At LinkouTaoyuan, Taiwan, 333|Xi'An, Shaanxi, China, 710061|Hangzhou, Zhejiang, China, 310014 The First Affiliated Hospital Of Wenzhou Medical UniversityWenzhou, Zhejiang, China, 325000|Ostrava, Czechia, 708 52 Fakultni Nemocnice Kralovske VinohradyPraha 10, Czechia, 10034 Fakultni Thomayerova NemocnicePraha 4 - Krc, Czechia, 140 59 Bata HospitalZlin, Czechia, 762 75|Aarhus N, Denmark, 8200 Herlev HospitalHerlev, Denmark, 2730 H:S RigshospitaletKÃ¸benhavn, Denmark, 2100|Helsinki, Finland, 00180|Besancon, France, 25030 HÃ´pital Saint AndrÃ© - BordeauxBordeaux, France, 33000 Centre De Lutte Contre Le Cancer FranÃ§ois BaclesseCaen Cedex 5, France, 14076 Centre Jean PerrinClermont Ferrand Cedex 1, France, 63011 Centre Oscar Lambret - LilleLille Cedex, France, 59020 Centre LÃ©on BÃ©rardLyon Cedex, France, 69008 Institut Paoli-Calmettes - MarseilleMarseille, France, 13273 Cochin - ParisParis, France, 75674 HÃ´pital D'Instruction Des ArmÃ©es BeginSaint Mande, France, 94160 Clinique Saint AnneStrasbourg, France, 67000 Centre MÃ©dico-Chirurgical FochSuresnes, France, 92151|Freiburg, Baden-WÃ¼rttemberg, Germany, 79106 Eberhard-Karls-UniversitÃ¤t TÃ¼bingenTÃ¼bingen, Baden-WÃ¼rttemberg, Germany, 72076 UniversitÃ¤tsklinikum UlmUlm, Baden-WÃ¼rttemberg, Germany, 89081|Erlangen, Bayern, Germany, 91054|DÃ¼sseldorf, Nordrhein-Westfalen, Germany, 40225|Mainz, Rheinland-Pfalz, Germany, 55131|Dresden, Sachsen, Germany, 01307|Berlin, Germany, 10967 Medizinische FakultÃ¤t Der Otto-Von-Guericke UniversitÃ¤tMagdeburg, Germany, 39120 Hong Kong Queen Mary HospitalHong Kong, Hong Kong Princess Margaret HospitalKowloon, Hong Kong Queen Elizabeth HospitalKowloon, Hong Kong Prince Of Wales HospitalShatin, Hong Kong|Budapest, Hungary, 1062 Bajcsy Zsilinszky Korhaz-RendelointezetBudapest, Hungary, 1106 Orszagos Onkologiai IntezetBudapest, Hungary, 1122 Debreceni Egyetem Klinikai KozpontDebrecen, Hungary, 4032 Pecsi Tudomanyegyetem Klinikai KozpontPecs, Hungary, 7624|Cork, Ireland AmnchDublin, Ireland, 24|Haifa, Israel, 3109601 Hadassah Hebrew University Hospital Ein KeremJerusalem, Israel, 9112001 Meir Medical CenterKfar Saba, Israel, 4428164 Rabin Medical Center - Beilinson CampusPetah Tikva, Israel, 4941492 Chaim Sheba Medical CenterRamat Gan, Israel, 5266202|ForlÃ¬-Cesena, Emilia-Romagna, Italy, 47014 Ausl ModenaModena, Emilia-Romagna, Italy, 41012 A.O.U. Di Modena - PoliclinicoModena, Emilia-Romagna, Italy, 41124|Roma, Lazio, Italy, 00152 Fondazione Policlinico Universitario Agostino GemelliRoma, Lazio, Italy, 00168|Milano, Lombardia, Italy, 20133 Irccs Istituto Europeo Di Oncologia (Ieo)Milano, Lombardia, Italy, 20141 Asst Grande Ospedale Metropolitano NiguardaMilano, Lombardia, Italy, 20162|Torino, Piemonte, Italy, 10043|Pisa, Toscana, Italy, 56126|Verona, Veneto, Italy, 37134|Nagoya, Aichi, Japan, 466-8560|Akita, Japan, 010-8543 Kyushu University HospitalFukuoka, Japan, 812-8582 Hiroshima City Hiroshima Citizens HospitalHiroshima, Japan, 730-8518 Kumamoto University HospitalKumamoto, Japan, 860-8556 Niigata University Medical And Dental HospitalNiigata, Japan, 951-8520 Osaka International Cancer InstituteOsaka, Japan, 541-8567 Tokushima University HospitalTokushima, Japan, 770-8503 Toyama University HospitalToyama, Japan, 930-0194 Korea, Republic Of, Gyeonggido National Cancer CenterGoyang-Si, Gyeonggido, Korea, Republic Of, 410-769 Korea, Republic Of Asan Medical CenterSeoul, Korea, Republic Of, 05505 Samsung Medical CenterSeoul, Korea, Republic Of, 06351 Yonsei University College Of MedicineSeoul, Korea, Republic Of, 120-752|Hirosaki, Aomori, Japan, 036-8563|Matsuyama, Ehime, Japan, 791-0280|Maebashi, Gunma, Japan, 371-8511 Gunma Prefectural Cancer CenterOta, Gunma, Japan, 373-8550|Sapporo, Hokkaido, Japan, 060-8543 Hokkaido University HospitalSapporo, Hokkaido, Japan, 060-8648|Kobe, Hyogo, Japan, 650-0047|Tsukuba, Ibaraki, Japan, 305-8576|Morioka, Iwate, Japan, 028-3695|Yokohama, Kanagawa, Japan, 236-0004|Osakasayama, Osaka, Japan, 589-8511|Hidaka, Saitama, Japan, 350-1298|Bunkyo-Ku, Tokyo, Japan, 113-8603 National Cancer Center HospitalChuo-Ku, Tokyo, Japan, 104-0045 The Cancer Institute Hospital Of JfcrKoto-Ku, Tokyo, Japan, 135-8550 Keio University HospitalShinjuku-Ku, Tokyo, Japan, 160-8582|Amsterdam, Netherlands, 1066 Cx Erasmus Medisch CentrumRotterdam, Netherlands, 3075 Ea|Bydgoszcz, Poland, 85-796 Swietokrzyskie Centrum OnkologiiKielce, Poland, 25-734 Przychodnia Lekarska KomedKonin, Poland, 62-500 Salve Medica Sp. Z O.O. Sp.K.Lodz, Poland, 91-211 Samodzielny Publiczny Zespol Gruzlicy I Chorob PlucOlsztyn, Poland, 10-357 Szpital Kliniczny Przemienienia PanskiegoPoznan, Poland, 60-569 Uniwersytecki Szpital Kliniczny Im. J. Mikulicza-RadeckiegoWroclaw, Poland, 50-556|Coimbra, Portugal, 3000-075 Instituto PortuguÃªs De Oncologia Francisco Gentil - CoimbraCoimbra, Portugal, 3000-075 Hospital Cuf Infante SantoLisboa, Portugal, 1350-070 Centro Hospitalar De Lisboa Norte - Hospital Santa MariaLisboa, Portugal, 1649-035 Chup, Epe - Hospital De Santo AntonioPorto, Portugal, 4099-001 Russian Federation Krasnoyarsk Regional Clinical Oncology DispensaryKrasnoyarsk, Russian Federation, 660133 Moscow Scient. Res. Institute Of Oncology N.A P.A. HertzenMoscow, Russian Federation, 125284 Urological Center PomcNizhny Novgorod, Russian Federation, 603109 Clinical Oncological Dispensary Of Omsk RegionOmsk, Russian Federation, 644013 Samara Regional Clinical Oncology DispensarySamara, Russian Federation, 443031 Bashkir State Medical UniversityUfa, Russian Federation, 450008|Loures, Lisboa, Portugal, 2674-514|Bratislava, Slovakia, 833 10 Uroexam, Spol. S R.O.Nitra, Slovakia, 949 01 Poko Poprad S.R.O.Poprad, Slovakia, 085 01|CÃ³rdoba, AndalucÃ­a, Spain, 14004|Badalona, Barcelona, Spain, 08916 Institut CatalÃ  D'Oncologia HospitaletL'Hospitalet De Llobregat, Barcelona, Spain, 08907|Barcelona, Catalunya, Spain, 08003|Barcelona, Spain, 08035 Hospital San Pedro De AlcÃ¡ntaraCÃ¡ceres, Spain, 10003 Md Anderson International Espanya, S.A.Madrid, Spain, 28033 Hospital RamÃ³n Y CajalMadrid, Spain, 28034 Hospital Universitario 12 De OctubreMadrid, Spain, 28041 Hospital Virgen De La VictoriaMÃ¡laga, Spain, 29010 Instituto Valenciano De OncologÃ­aValencia, Spain, 46009 Hospital General Universitario De ValenciaValencia, Spain, 46014|Palma De Mallorca, Illes Baleares, Spain, 07120|Stockholm, Sweden, 118 83 Karolinska InstitutetStockholm, Sweden, 17167 Norrlands Universitetssjukhus, UmeÃ¥UmeÃ¥, Sweden, 901 85|Basel, Basel-Stadt, Switzerland, 4031|Chur, GraubÃ¼nden, Switzerland, 7000|St. Gallen, Sankt Gallen, Switzerland, 9007 Taiwan|Bebington, Merseyside, United Kingdom, Ch63 4Jy|Taunton, Somerset, United Kingdom, Ta1 5Da|London, United Kingdom, Sw3 6Jj|Anchorage, Alaska, United States, 99503|Phoenix, Arizona, United States, 85004 Arizona Oncology Associates, PcTucson, Arizona, United States, 85711 University Of Arizona Cancer CenterTucson, Arizona, United States, 85719|Los Angeles, California, United States, 90033 Uc Davis Comprehensive Cancer CenterSacramento, California, United States, 95817 Sansum ClinicSanta Barbara, California, United States, 93105|Littleton, Colorado, United States, 80120-4413|New Haven, Connecticut, United States, 06510|Orlando, Florida, United States, 32806 Woodlands Medical Specialists, PaPensacola, Florida, United States, 32503|Chicago, Illinois, United States, 60611|Westwood, Kansas, United States, 66205|New Orleans, Louisiana, United States, 70112|Las Vegas, Nevada, United States, 89169|New York, New York, United States, 10016 Weill Cornell Medical CollegeNew York, New York, United States, 10065|Tigard, Oregon, United States, 97223|Pittsburgh, Pennsylvania, United States, 15232|Greenville, South Carolina, United States, 29607|Watertown, South Dakota, United States, 57201|Denton, Texas, United States, 76210 The Center For Cancer And Blood DisordersFort Worth, Texas, United States, 76104 Houston Methodist HospitalHouston, Texas, United States, 77030-2707|Seattle, Washington, United States, 98101 Summit Cancer CenterSpokane, Washington, United States, 99208","Alaska|Arizona|California|Colorado|Connecticut|Florida|Illinois|Kansas|Louisiana|Nevada|New York|Oregon|Pennsylvania|South Carolina|South Dakota|Texas|Washington","Australia|Austria|Belgium|Canada|China|Czechia|Denmark|Finland|France|Germany|Hungary|Ireland|Israel|Italy|Japan|Netherlands|Poland|Portugal|Slovakia|Spain|Sweden|Switzerland|United Kingdom|United States","New South Wales Mid North Coast Cancer Institute|Queensland Pindara Private Hospital|Victoria Monash Medical Centre|Landesklinikum Krems|Uz Gent|Ontario Princess Margaret Hospital-University Health Network|Ottawa Hospital-General Campus|Quebec Sir Mortimer B. Davis Jewish General Hospital|Beijing Friendship Hospital, Capital Medical University|Fujian Fujian Medical University Union Hospital|Guangdong Sun Yat-Sen University Cancer Center|Hebei The 2Nd Hospital Of Hebei Medical University|Hospital, Sichuan University|Hubei Hubei Cancer Hospital|Hunan Hunan Cancer Hospital|Jiangsu Nj Drum Tower Hospital, The Affil Hos Of Nj Univ Med School|Jiangxi The First Affiliated Hospital Of Nanchang University|Jilin The First Hospital Of Jilin University|Liaoning Liaoning Cancer Hospital And Institute|Medical University Hospital|Shaanxi The 1St Affiliated Hospital Of Xi'An Jiaotong University|Zhejiang Zhejiang Provincial People's Hospital|Fakultni Nemocnice Ostrava|Aarhus Universitetshospital, Skejby|Docrates Klinikka|Hopital Jean Minjoz|Baden-WÃ¼rttemberg UniversitÃ¤tsklinikum Freiburg|Bayern UniversitÃ¤tsklinikum Erlangen|Nordrhein-Westfalen Heinrich-Heine-UniversitÃ¤t DÃ¼sseldorf|Rheinland-Pfalz UniversitÃ¤tsmedizin Der Johannes Gutenberg UniversitÃ¤t Mainz|Sachsen UniversitÃ¤tsklinikum Carl Gustav Carus Dresden|Vivantes Klinikum Am Urban|Mh Egeszsegugyi Kozpont|Cork University Hospital|Rambam Health Corporation|Emilia-Romagna Irst Istituto Scientifico Romagnolo Per Studio E Cura Tumori|Lazio A.O. San Camillo-Forlanini|Lombardia Fondazione Irccs Istituto Nazionale Dei Tumori|Piemonte A.O.U. San Luigi Gonzaga|Toscana A.O.U. Pisana|Veneto A.O.U. Integrata Verona|Aichi Nagoya University Hospital|Akita University Hospital|Aomori Hirosaki University Hospital|Ehime National Hospital Organization Shikoku Cancer Center|Gunma Gunma University Hospital|Hokkaido Sapporo Medical University Hospital|Hyogo Kobe City Medical Center General Hospital|Ibaraki University Of Tsukuba Hospital|Iwate Iwate Medical University Hospital|Kanagawa Yokohama City University Hospital|Osaka Kindai University Hospital|Saitama Saitama Medical University International Medical Center|Tokyo Nippon Medical School Hospital|Nederlands Kanker Instituut|Centrum Onkologii Im. Prof. Franciszka Lukaszczyka|Chuc - Hospitais Da Universidade De Coimbra|Lisboa Hospital Beatriz Angelo|Narodny Onkologicky Ustav|AndalucÃ­a Hospital Reina SofÃ­a|Barcelona Institut CatalÃ  D'Oncologia Badalona|Catalunya Hospital Del Mar|Ciutat SanitÃ ria I Universitaria De La Vall D'Hebron|Illes Baleares Hospital Universitari Son Espases|SÃ¶dersjukhuset|Basel-Stadt UniversitÃ¤tsspital Basel|GraubÃ¼nden Kantonsspital GraubÃ¼nden|Sankt Gallen Kantonsspital St. Gallen|, Merseyside Clatterbridge Centre For Oncology|, Somerset Musgrove Park Hospital|The Royal Marsden Hospital|Alaska Clinical Research Center, Llc|Univeristy Of Arizona Cancer Center|University Of Southern California|Rocky Mountain Cancer Centers|Yale Cancer Center|Uf Cancer Center At Orlando Health|Northwestern Medical Faculty Foundation Div Of Hem/Oncology|University Of Kansas Medical Center|Louisiana State University|Comprehensive Cancer Centers Of Nevada|Nyu Langone Medical Center|Compass Oncology|University Of Pittsburgh|Bon Secours St. Francis Hospital|Prairie Lakes Cancer Center|Texas Oncology-Denton South|Virginia Mason Medical Center",{"$nulls":3},"Bayer Study Director","2019-09-20","2020-05-25T16:38:42.098","2020-05-26T17:10:42.972","NCT03410693"]
["5ecbf492feab101b1553097a","NCT03410693","2020-02-18","Bayer","BAYN","Active, not recruiting","Study of Rogaratinib (BAY1163877) vs Chemotherapy in Patients With FGFR (Fibroblast Growth Factor Receptor)-Positive Locally Advanced or Metastatic Urothelial Carcinoma (FORT-1)","Bay-1163877",null,"Yes","['Bay-1163877']","Unknown",null,"Phase 2/Phase 3",2,171,"Actual","2018-05-31","2020-11-30","OS","Overall Survival",{"$nulls":3},"This is a randomized, open-label, multicenter Phase 2/3 study to evaluate the efficacy and safety of rogaratinib (BAY 1163877) compared to chemotherapy in patients with FGFRpositive locally advanced or metastatic urothelial carcinoma who have received Prior platinum-containing chemotherapy.\n\nThe primary objective of the entire study is to compare rogaratinib (BAY1163877) with chemotherapy (docetaxel, paclitaxel or vinflunine) in terms of prolonging the Overall survival (OS) of patients with FGFR positive urothelial carcinoma.\n\nAt randomization, patients will have locally advanced or metastatic urothelial carcinoma and have received at least one prior platinum-containing chemotherapy regimen. Only patients with FGFR1 or 3 positive tumors can be randomized into the study. Archival tumor tissue is adequate for testing of FGFR1 and 3 mRNA expressions, which will be determined centrally using an RNA in situ hybridization (RNA-ISH) test. Approximately 42 % of UC patients with locally advanced or metastatic UC are identified as FGFR-positive by the RNA-ISH cut-off applied.",null,"A Randomized, Open Label, Multicenter Phase 2/3 Study to Evaluate the Efficacy and Safety of Rogaratinib (BAY1163877) Compared to Chemotherapy in Patients With FGFR-positive Locally Advanced or Metastatic Urothelial Carcinoma Who Have Received Prior Platinum-containing Chemotherapy",17403,"Carcinoma, Transitional Cell","Noma|Carcinoma|Transitional Cell Carcinoma","Mouth Diseases|Oncology Solid Tumor","Ear, Nose and Throat|Oncology","Experimental|Active Comparator","Rogaratinib|Chemotherapy",null,"Drug","Rogaratinib (BAY1163877)|Chemotherapy","Rogaratinib administered as oral (p.o.) tablets twice daily (b.i.d.) continuously|Chemotherapy as taxane (docetaxel or paclitaxel) or vinflunine administered through intravenous (i.v.) infusion every 3 weeks (on day 1 of a 21-day cycle) The choice of the chemotherapy is at the discretion of the investigator, taking into consideration the status of the authorization in the given Country (i.e. the drug has to be approved at least for one indication in the given country).",null,"Rogaratinib|Chemotherapy","\n\n * Existence of archival or fresh biopsy for FGFR testing\n * FGFR testing of patients will be performed at the investigators' discretion up to a max. of 90 days prior to start of screening.\n\nInvestigators should ensure all patients will be eligible in terms of disease status and lines of treatment within this timeframe.\n\n * Documented urothelial carcinoma (transitional cell carcinoma) including urinary bladder, renal pelvis, ureters, urethra meeting all of the following criteria * Histologically or cytologically confirmed (patients with mixed histologies are required to have a dominant transitional cell pattern.)\n    * Locally advanced (T4b, any N; or any T, N 2âˆ’3) or metastatic disease (any T, any N and M1). Locally advanced bladder cancer must be unresectable i.e. invading the pelvic or abdominal wall (stage T4b) or presenting with bulky nodal disease (N2-3).\n   \n   \n * ECOG (Eastern Cooperative Oncology Group) Performance Status of 0 or 1\n * Disease progression during or following treatment with at least one platinum-containing regimen (patients should have been treated for at least 2 cycles). In patients who received prior adjuvant/ neoadjuvant platinum-containing chemotherapy, progression had to occur within 12 months of treatment.\n * High FGFR1 or 3 mRNA (Messenger ribonucleic acid) expression levels (RNAscope score of 3+ or 4+; measurement is part of this protocol) in archival or fresh Tumor biopsy specimen\n * At least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST v.1.1) in contrast enhanced (unless contraindicated) CT or MRI\n\n","\n\n * Previous or concurrent cancer except * cervical carcinoma in situ\n    * treated basal-cell or squamous cell skin carcinoma\n    * any cancer curatively treated > 3 years before randomization\n    * curatively treated incidental prostate cancer (T1/T2a)\n   \n   \n * Ongoing or previous anti-cancer treatment within 4 weeks before randomization.\n * More than two prior lines of systemic anti-cancer therapy for urothelial carcinoma\n * Ongoing or previous treatment with anti-FGFR directed therapies (e.g. receptor tyrosine kinase inhibitors including rogaratinib or FGFRspecific antibodies) or with taxanes or vinflunine\n * Unresolved toxicity higher than National Cancer Institute's Common Terminology Criteria for Adverse Events, version 4.03 (CTCAE v.4.03) Grade 1 attributed to any prior therapy/ procedure excluding alopecia, anemia and/ or hypothyroidism\n * History or current condition of an uncontrolled cardiovascular disease including any of the following conditions: * Congestive heart failure (CHF) NYHA (New York Heart Association) > Class 2\n    * Unstable angina (symptoms of angina at rest) or new-onset angina (within last 3 months before randomization)\n    * Myocardial infarction (MI) within past 6 months before randomization\n    * Unstable cardiac arrhythmias requiring anti-arrhythmic therapy. Patients with arrhythmia under control with anti-arrhythmic therapy such as beta-blockers or digoxin are eligible.\n   \n   \n * Arterial or venous thrombotic events or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within 3 months before randomization\n * Current evidence of endocrine alteration of calcium phosphate homeostasis (e.g. parathyroid disorder, history of parathyroidectomy, tumor lysis, tumoral calcinosis, paraneoplastic hypercalcemia)\n * Any hemorrhage / bleeding event â‰¥ CTCAE v.4.03 Grade 3 within 4 weeks before randomization\n * Current diagnosis of any retinal detachment, retinal pigment epithelial detachment (RPED), serous retinopathy or retinal vein occlusion",{"$nulls":4},"Actual","2018-01-25","Actual","Anticipated","2020-11-30","Anticipated","2020-02-01","2018-01-19","2018-01-19","2020-02-17","Yes","Urothelial carcinoma","Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"2016-004340-11","EudraCT Number","Overall Survival","Defined as the time (days) from randomization to death due to any cause. Patients alive at the date of data cut-off for analysis will be censored at the last date known to be alive.","Up to 45 months","Progression-free survival (PFS)|Objective response rate (ORR)|Disease-control rate (DCR)|Duration of response (DOR)|Incidence of Adverse Events as a measure of safety and tolerability","Defined as the time (days) from randomization to date of first observed disease progression (radiological or clinical assessment) or death due to any cause, if death occurs before progression is documented. For patients without documented radiological or clinical progression or death at the time of analysis, PFS will be censored at the last actual visit date of tumor evaluation.|Defined as the percentage of patients with complete response (CR) or partial Response (PR). Patients for whom overall best response is not CR or PR, as well as patients without any post-baseline tumor assessment will be considered non-responders.|Defined as the percentage of patients, whose overall best response was not progressive disease|Defined as the time from the first documented objective response of PR or CR, whichever is noted earlier, to disease progression or death (if death occurs before progression is documented). DOR will be defined for responders only, i.e. patients with a CR or PR.|Up to 45 months","Up to 45 months|PD (i.e. CR, PR, Stable Disease",{"$nulls":3},"Coffs Harbour, New South Wales, Australia, 2450 Northern Cancer InstituteSt Leonards, New South Wales, Australia, 2065 Macquarie University HospitalSydney, New South Wales, Australia, 2109 Riverina Cancer Care CentreWagga Wagga, New South Wales, Australia, 2650 Sydney Adventist HospitalWahroonga, New South Wales, Australia, 2076|Benowa, Queensland, Australia, 4217|Clayton, Victoria, Australia, 3168|Krems, Austria, 3500 Krankenhaus Der Barmherzigen BrÃ¼derWien, Austria, 1020 Allgemeines Krankenhaus Der Stadt WienWien, Austria, 1090 Wilhelminenspital Der Stadt WienWien, Austria, 1160|Gent, Belgium, 9000 Uz Leuven GasthuisbergLeuven, Belgium, 3000 Clinique Saint-PierreOttignies, Belgium, 1340|Toronto, Ontario, Canada, M5G 2M9|Ottawa, Canada, K1H 8L6|Montreal, Quebec, Canada, H3T 1E2|Beijing, China, 100071 First Affiliated Hospital Of Guangzhou Medical UniversityGuangzhou, China Fudan University Shanghai Cancer CenterShanghai, China, 200032 Huadong Hospital, Affiliated To Fudan UniversityShanghai, China, 200040|Fuzhou, Fujian, China, 350001|Guangzhou, Guangdong, China, 510060|Wuhan, Hubei, China, 430079|Nanjing, Jiangsu, China, 210008 Jiangsu Cancer HospitalNanjing, Jiangsu, China, 210009|Shengyang, Liaoning, China, 110042|Ostrava, Czechia, 708 52 Fakultni Nemocnice Kralovske VinohradyPraha 10, Czechia, 10034 Fakultni Thomayerova NemocnicePraha 4 - Krc, Czechia, 140 59 Bata HospitalZlin, Czechia, 762 75|Aarhus N, Denmark, 8200 Herlev HospitalHerlev, Denmark, 2730 H:S RigshospitaletKÃ¸benhavn, Denmark, 2100|Helsinki, Finland, 00180|Besancon, France, 25030 HÃ´pital Saint AndrÃ© - BordeauxBordeaux, France, 33000 Centre De Lutte Contre Le Cancer FranÃ§ois BaclesseCaen Cedex 5, France, 14076 Centre Jean PerrinClermont Ferrand Cedex 1, France, 63011 Centre Oscar Lambret - LilleLille Cedex, France, 59020 Centre LÃ©on BÃ©rardLyon Cedex, France, 69008 Institut Paoli-Calmettes - MarseilleMarseille, France, 13273 Cochin - ParisParis, France, 75674 HÃ´pital D'Instruction Des ArmÃ©es BeginSaint Mande, France, 94160 Clinique Saint AnneStrasbourg, France, 67000 Centre MÃ©dico-Chirurgical FochSuresnes, France, 92151|TÃ¼bingen, Baden-WÃ¼rttemberg, Germany, 72076|DÃ¼sseldorf, Nordrhein-Westfalen, Germany, 40225|Mainz, Rheinland-Pfalz, Germany, 55131 Hong Kong Prince Of Wales HospitalShatin, Hong Kong|Budapest, Hungary, 1062 Orszagos Onkologiai IntezetBudapest, Hungary, 1122 Pecsi Tudomanyegyetem Klinikai KozpontPecs, Hungary, 7624|Cork, Ireland AmnchDublin, Ireland, 24|Haifa, Israel, 3109601 Hadassah Hebrew University Hospital Ein KeremJerusalem, Israel, 9112001 Meir Medical CenterKfar Saba, Israel, 4428164 Clalit Health Services Through Rabin Medical Center - Beilinson CampusPetah Tikva, Israel, 4941492 Chaim Sheba Medical CenterRamat Gan, Israel, 5266202|ForlÃ¬-Cesena, Emilia-Romagna, Italy, 47014 Ausl ModenaModena, Emilia-Romagna, Italy, 41012 A.O.U. Di Modena - PoliclinicoModena, Emilia-Romagna, Italy, 41124|Roma, Lazio, Italy, 00152 Fondazione Policlinico Universitario Agostino Gemelli IrccsRoma, Lazio, Italy, 00168|Milano, Lombardia, Italy, 20133 Irccs Istituto Europeo Di Oncologia (Ieo)Milano, Lombardia, Italy, 20141 Asst Grande Ospedale Metropolitano NiguardaMilano, Lombardia, Italy, 20162|Torino, Piemonte, Italy, 10043|Pisa, Toscana, Italy, 56126|Verona, Veneto, Italy, 37134|Nagoya, Aichi, Japan, 466-8560|Akita, Japan, 010-8543 Kyushu University HospitalFukuoka, Japan, 812-8582 Hiroshima City Hiroshima Citizens HospitalHiroshima, Japan, 730-8518 Kumamoto University HospitalKumamoto, Japan, 860-8556 Niigata University Medical And Dental HospitalNiigata, Japan, 951-8520 Osaka International Cancer InstituteOsaka, Japan, 541-8567 Toyama University HospitalToyama, Japan, 930-0194 Korea, Republic Of, Gyeonggido National Cancer CenterGoyang-Si, Gyeonggido, Korea, Republic Of, 410-769 Korea, Republic Of Asan Medical CenterSeoul, Korea, Republic Of, 05505 Samsung Medical CenterSeoul, Korea, Republic Of, 06351 Yonsei University College Of MedicineSeoul, Korea, Republic Of, 120-752|Hirosaki, Aomori, Japan, 036-8563|Maebashi, Gunma, Japan, 371-8511 Gunma Prefectural Cancer CenterOta, Gunma, Japan, 373-8550|Sapporo, Hokkaido, Japan, 060-8543 Hokkaido University HospitalSapporo, Hokkaido, Japan, 060-8648|Kobe, Hyogo, Japan, 650-0047|Tsukuba, Ibaraki, Japan, 305-8576|Morioka, Iwate, Japan, 028-3695|Yokohama, Kanagawa, Japan, 236-0004|Osakasayama, Osaka, Japan, 589-8511|Hidaka, Saitama, Japan, 350-1298|Bunkyo-Ku, Tokyo, Japan, 113-8603 National Cancer Center HospitalChuo-Ku, Tokyo, Japan, 104-0045 The Cancer Institute Hospital Of JfcrKoto-Ku, Tokyo, Japan, 135-8550 Keio University HospitalShinjuku-Ku, Tokyo, Japan, 160-8582|Amsterdam, Netherlands, 1066 Cx Erasmus Medisch CentrumRotterdam, Netherlands, 3075 Ea|Bydgoszcz, Poland, 85-796 Swietokrzyskie Centrum OnkologiiKielce, Poland, 25-734 Przychodnia Lekarska KomedKonin, Poland, 62-500 Samodzielny Publiczny Zespol Gruzlicy I Chorob PlucOlsztyn, Poland, 10-357 Szpital Kliniczny Przemienienia PanskiegoPoznan, Poland, 60-569 Uniwersytecki Szpital Kliniczny Um We WroclawiuWroclaw, Poland, 50-556|Coimbra, Portugal, 3000-075 Hospital Cuf Infante SantoLisboa, Portugal, 1350-070 Chuln - Hospital Santa MariaLisboa, Portugal, 1649-035 Chup - Hospital Santo AntonioPorto, Portugal, 4099-001 Russian Federation Krasnoyarsk Regional Clinical Oncology DispensaryKrasnoyarsk, Russian Federation, 660133 Moscow Scient. Res. Institute Of Oncology N.A P.A. HertzenMoscow, Russian Federation, 125284 Urological Center PomcNizhny Novgorod, Russian Federation, 603109 Clinical Oncological Dispensary Of Omsk RegionOmsk, Russian Federation, 644013 Bashkir State Medical UniversityUfa, Russian Federation, 450008|Loures, Lisboa, Portugal, 2674-514|Bratislava, Slovakia, 833 10 Uroexam, Spol. S R.O.Nitra, Slovakia, 949 01 Poko Poprad S.R.O.Poprad, Slovakia, 085 01|CÃ³rdoba, AndalucÃ­a, Spain, 14004|Badalona, Barcelona, Spain, 08916 Institut CatalÃ  D'Oncologia HospitaletL'Hospitalet De Llobregat, Barcelona, Spain, 08907|Barcelona, Catalunya, Spain, 08003|Barcelona, Spain, 08035 Hospital San Pedro De AlcÃ¡ntaraCÃ¡ceres, Spain, 10003 Hospital RamÃ³n Y CajalMadrid, Spain, 28034 Hospital Universitario 12 De OctubreMadrid, Spain, 28041 Hospital Virgen De La VictoriaMÃ¡laga, Spain, 29010 Instituto Valenciano De OncologÃ­aValencia, Spain, 46009 Hospital General Universitario De ValenciaValencia, Spain, 46014|Palma De Mallorca, Illes Baleares, Spain, 07120|Stockholm, Sweden, 118 83 Karolinska InstitutetStockholm, Sweden, 17167|Basel, Basel-Stadt, Switzerland, 4031|Chur, GraubÃ¼nden, Switzerland, 7000|St. Gallen, Sankt Gallen, Switzerland, 9007 Taiwan Taichung Veterans General HospitalTaichung, Taiwan, 40705 National Cheng Kung University HospitalTainan, Taiwan National Taiwan University HospitalTaipei, Taiwan, 10002 Taipei Veterans General HospitalTaipei, Taiwan, 11217 Chang Gung Memorial Hospital At LinkouTaoyuan, Taiwan, 333|Bebington, Merseyside, United Kingdom, Ch63 4Jy|London, United Kingdom, Sw3 6Jj|Anchorage, Alaska, United States, 99503|Tucson, Arizona, United States, 85719|Los Angeles, California, United States, 90033 Uc Davis Comprehensive Cancer CenterSacramento, California, United States, 95817 Sansum ClinicSanta Barbara, California, United States, 93105|Littleton, Colorado, United States, 80120-4413|Orlando, Florida, United States, 32806|Westwood, Kansas, United States, 66205|Las Vegas, Nevada, United States, 89169|Tigard, Oregon, United States, 97223|Pittsburgh, Pennsylvania, United States, 15232|Greenville, South Carolina, United States, 29607|Denton, Texas, United States, 76210 Houston Methodist HospitalHouston, Texas, United States, 77030-2707|Seattle, Washington, United States, 98101 Summit Cancer CenterSpokane, Washington, United States, 99208","Alaska|Arizona|California|Colorado|Florida|Kansas|Nevada|Oregon|Pennsylvania|South Carolina|Texas|Washington","Australia|Austria|Belgium|Canada|China|Czechia|Denmark|Finland|France|Germany|Hungary|Ireland|Israel|Italy|Japan|Netherlands|Poland|Portugal|Slovakia|Spain|Sweden|Switzerland|United Kingdom|United States","New South Wales Mid North Coast Cancer Institute|Queensland Pindara Private Hospital|Victoria Monash Medical Centre|Landesklinikum Krems|Uz Gent|Ontario Princess Margaret Hospital-University Health Network|Ottawa Hospital-General Campus|Quebec Sir Mortimer B. Davis Jewish General Hospital|Fifth Medical Center, General Hospital Of The Chinese People|Fujian Fujian Medical University Union Hospital|Guangdong Sun Yat-Sen University Cancer Center|Hubei Hubei Cancer Hospital|Jiangsu Nj Drum Tower Hospital, The Affil Hos Of Nj Univ Med School|Liaoning Liaoning Cancer Hospital And Institute|Fakultni Nemocnice Ostrava|Aarhus Universitetshospital, Skejby|Docrates Klinikka|Hopital Jean Minjoz|Baden-WÃ¼rttemberg Eberhard-Karls-UniversitÃ¤t TÃ¼bingen|Nordrhein-Westfalen Heinrich-Heine-UniversitÃ¤t DÃ¼sseldorf|Rheinland-Pfalz UniversitÃ¤tsmedizin Der Johannes Gutenberg UniversitÃ¤t Mainz|Mh Egeszsegugyi Kozpont|Cork University Hospital|Rambam Health Corporation|Emilia-Romagna Irst Istituto Scientifico Romagnolo Per Studio E Cura Tumori|Lazio A.O. San Camillo-Forlanini|Lombardia Fondazione Irccs Istituto Nazionale Dei Tumori|Piemonte A.O.U. San Luigi Gonzaga|Toscana A.O.U. Pisana|Veneto A.O.U.I. Verona|Aichi Nagoya University Hospital|Akita University Hospital|Aomori Hirosaki University Hospital|Gunma Gunma University Hospital|Hokkaido Sapporo Medical University Hospital|Hyogo Kobe City Medical Center General Hospital|Ibaraki University Of Tsukuba Hospital|Iwate Iwate Medical University Hospital|Kanagawa Yokohama City University Hospital|Osaka Kindai University Hospital|Saitama Saitama Medical University International Medical Center|Tokyo Nippon Medical School Hospital|Nederlands Kanker Instituut|Centrum Onkologii Im. Prof. Franciszka Lukaszczyka|Ipo Coimbra|Lisboa Hospital Beatriz Angelo|Narodny Onkologicky Ustav|AndalucÃ­a Hospital Reina SofÃ­a|Barcelona Institut CatalÃ  D'Oncologia Badalona|Catalunya Hospital Del Mar|Ciutat SanitÃ ria I Universitaria De La Vall D'Hebron|Illes Baleares Hospital Universitari Son Espases|SÃ¶dersjukhuset|Basel-Stadt UniversitÃ¤tsspital Basel|GraubÃ¼nden Kantonsspital GraubÃ¼nden|Sankt Gallen Kantonsspital St. Gallen|, Merseyside Clatterbridge Centre For Oncology|Royal Marsden Hospital (London)|Alaska Clinical Research Center, Llc|University Of Arizona Cancer Center|University Of Southern California|Rocky Mountain Cancer Centers|Uf Cancer Center At Orlando Health|University Of Kansas Medical Center|Comprehensive Cancer Centers Of Nevada|Compass Oncology|University Of Pittsburgh|Bon Secours St. Francis Hospital|Texas Oncology-Denton South|Virginia Mason Medical Center",{"$nulls":3},"Bayer Study Director","2020-02-17","2020-05-25T16:38:42.725","2020-05-26T17:10:42.972","NCT03410693"]
["5ecbf492307e3d1b1f8d9ddc","NCT03410693","2020-04-17","Bayer","BAYN","Active, not recruiting","Study of Rogaratinib (BAY1163877) vs Chemotherapy in Patients With FGFR (Fibroblast Growth Factor Receptor)-Positive Locally Advanced or Metastatic Urothelial Carcinoma (FORT-1)","Bay-1163877",null,"Yes","['Bay-1163877']","Unknown",null,"Phase 2/Phase 3",2,172,"Actual","2018-05-31","2020-11-30","RR","Response Rate",{"$nulls":3},"This is a randomized, open-label, multicenter Phase 2/3 study to evaluate the efficacy and safety of rogaratinib (BAY 1163877) compared to chemotherapy in patients with FGFR-positive locally advanced or metastatic urothelial carcinoma who have received prior platinum-containing chemotherapy.\n\nThe primary objective is to demonstrate the superiority of rogaratinib over chemotherapy in terms of objective response rate (before: overall survivial) of urothelial carcinoma patients with FGFR positive tumors.\n\nAt randomization, patients will have locally advanced or metastatic urothelial carcinoma and have received at least one prior platinum-containing chemotherapy regimen. Only patients with FGFR1 or 3 positive tumors can be randomized into the study. Archival tumor tissue is adequate for testing of FGFR1 and 3 mRNA expressions, which will be determined centrally using an RNA in situ hybridization (RNA-ISH) test. Approximately 42 % of UC patients with locally advanced or metastatic UC are identified as FGFR-positive by the RNA-ISH cut-off applied.",null,"A Randomized, Open Label, Multicenter Phase 2/3 Study to Evaluate the Efficacy and Safety of Rogaratinib (BAY1163877) Compared to Chemotherapy in Patients With FGFR-positive Locally Advanced or Metastatic Urothelial Carcinoma Who Have Received Prior Platinum-containing Chemotherapy",17403,"Carcinoma, Transitional Cell","Noma|Carcinoma|Transitional Cell Carcinoma","Mouth Diseases|Oncology Solid Tumor","Ear, Nose and Throat|Oncology","Experimental|Active Comparator","Rogaratinib|Chemotherapy",null,"Drug","Rogaratinib (BAY1163877)|Chemotherapy","Rogaratinib administered as oral (p.o.) tablets twice daily (b.i.d.) continuously|Chemotherapy as taxane (docetaxel or paclitaxel) or vinflunine administered through intravenous (i.v.) infusion every 3 weeks (on day 1 of a 21-day cycle) The choice of the chemotherapy is at the discretion of the investigator, taking into consideration the status of the authorization or treatment guidelines in the given country.",null,"Rogaratinib|Chemotherapy","\n\n * Existence of archival or fresh biopsy for FGFR testing. Mandatory FGFR testing of patients will be performed prior to start of screening. The timing of the FGFR test is at the discretion of the investigator. Investigators should ensure all patients will be eligible in terms of disease status and lines of treatment.\n * Documented urothelial carcinoma (transitional cell carcinoma) including urinary bladder, renal pelvis, ureters, urethra meeting all of the following criteria * Histologically confirmed (Patients with mixed histologies are required to have a dominant transitional cell pattern.)\n    * Locally advanced (T4, any N; or any T, N 2âˆ’3) or metastatic disease (any T, any N and M1). Locally advanced bladder cancer must be unresectable i.e. invading the pelvic or abdominal wall (stage T4b) or presenting with bulky nodal disease (N2-3).\n   \n   \n * ECOG (Eastern Cooperative Oncology Group) Performance Status of 0 or 1\n * Disease progression during or following treatment with at least one platinum-containing regimen (patients should have been treated for at least 2 cycles). In patients who received prior adjuvant/ neoadjuvant platinum-containing chemotherapy, progression had to occur within 12 months of treatment.\n * High FGFR1 or 3 mRNA expression levels in archival or fresh tumor biopsy specimen quantified as outlined in the lab manual\n * At least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST v.1.1) in contrast enhanced (unless contraindicated) CT or MRI\n\n","\n\n * Previous or concurrent cancer except * cervical carcinoma in situ\n    * treated basal-cell or squamous cell skin carcinoma\n    * any cancer curatively treated > 3 years before randomization\n    * curatively treated incidental prostate cancer (T1/T2a)\n   \n   \n * Ongoing or previous treatment with anti-FGFR directed therapies (e.g. receptor tyrosine kinase inhibitors including rogaratinib or FGFR-specific antibodies) or with taxanes or vinflunine\n * More than two prior lines of systemic anti-cancer therapy for urothelial carcinoma given for advanced unresectable/ metastatic disease\n * Ongoing or previous anti-cancer treatment within 4 weeks before randomization.\n * Unresolved toxicity higher than National Cancer Institute's Common Terminology Criteria for Adverse Events, version 4.03 (CTCAE v.4.03) Grade 1 attributed to any prior therapy/ procedure excluding alopecia, anemia and/ or hypothyroidism\n * History or current condition of an uncontrolled cardiovascular disease including any of the following conditions: * Congestive heart failure (CHF) NYHA (New York Heart Association) > Class 2\n    * Unstable angina (symptoms of angina at rest) or new-onset angina (within last 3 months before randomization)\n    * Myocardial infarction (MI) within past 6 months before randomization\n    * Unstable cardiac arrhythmias requiring anti-arrhythmic therapy. Patients with arrhythmia under control with anti-arrhythmic therapy such as beta-blockers or digoxin are eligible.\n   \n   \n * Arterial or venous thrombotic events or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within 3 months before randomization\n * Current evidence of endocrine alteration of calcium phosphate homeostasis (e.g. parathyroid disorder, history of parathyroidectomy, tumor lysis, tumoral calcinosis, paraneoplastic hypercalcemia)\n * Current diagnosis of any retinal detachment, retinal pigment epithelial detachment (RPED), serous retinopathy or retinal vein occlusion\n * Any hemorrhage / bleeding event â‰¥ CTCAE v.4.03 Grade 3 within 4 weeks before randomization",{"$nulls":4},"Actual","2018-01-25","Actual","Anticipated","2020-11-30","Anticipated","2020-04-01","2018-01-19","2018-01-19","2020-04-16","Yes","Urothelial carcinoma","Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"2016-004340-11","EudraCT Number","Objective response rate (ORR)","Defined as the percentage of patients with complete response (CR) or partial response (PR). Patients for whom overall best response is not CR or PR, as well as patients without any post-baseline tumor assessment will be considered non-responders.","Up to 45 months","Progression-free survival (PFS)|Disease-control rate (DCR)|Duration of response (DOR)|Incidence of Adverse Events as a measure of safety and tolerability|Other Pre-specified Outcome Measures:|Overall survival","Defined as the time (days) from randomization to date of first observed disease progression (radiological or clinical assessment) or death due to any cause, if death occurs before progression is documented. For patients without documented radiological or clinical progression or death at the time of analysis, PFS will be censored at the last actual visit date of tumor evaluation.|Defined as the percentage of patients, whose overall best response was not progressive disease|Defined as the time from the first documented objective response of PR or CR, whichever is noted earlier, to disease progression or death (if death occurs before progression is documented). DOR will be defined for responders only, i.e. patients with a CR or PR.|Up to 45 months|Other Pre-specified Outcome Measures:|Defined as the time (days) from randomization to death due to any cause. Patients alive at the date of data cut-off for analysis will be censored at the last date known to be alive.","Up to 45 months|PD (i.e. CR, PR, Stable Disease",{"$nulls":3},"Coffs Harbour, New South Wales, Australia, 2450 Northern Cancer InstituteSt Leonards, New South Wales, Australia, 2065 Macquarie University HospitalSydney, New South Wales, Australia, 2109 Riverina Cancer Care CentreWagga Wagga, New South Wales, Australia, 2650 Sydney Adventist HospitalWahroonga, New South Wales, Australia, 2076|Benowa, Queensland, Australia, 4217|Clayton, Victoria, Australia, 3168|Krems, Austria, 3500 Krankenhaus Der Barmherzigen BrÃ¼derWien, Austria, 1020 Allgemeines Krankenhaus Der Stadt WienWien, Austria, 1090 Wilhelminenspital Der Stadt WienWien, Austria, 1160|Gent, Belgium, 9000 Uz Leuven GasthuisbergLeuven, Belgium, 3000 Clinique Saint-PierreOttignies, Belgium, 1340|Toronto, Ontario, Canada, M5G 2M9|Ottawa, Canada, K1H 8L6|Montreal, Quebec, Canada, H3T 1E2|Beijing, China, 100071 First Affiliated Hospital Of Guangzhou Medical UniversityGuangzhou, China Fudan University Shanghai Cancer CenterShanghai, China, 200032 Huadong Hospital, Affiliated To Fudan UniversityShanghai, China, 200040|Fuzhou, Fujian, China, 350001|Guangzhou, Guangdong, China, 510060|Wuhan, Hubei, China, 430079|Nanjing, Jiangsu, China, 210008 Jiangsu Cancer HospitalNanjing, Jiangsu, China, 210009|Shengyang, Liaoning, China, 110042|Ostrava, Czechia, 708 52 Fakultni Nemocnice Kralovske VinohradyPraha 10, Czechia, 10034 Fakultni Thomayerova NemocnicePraha 4 - Krc, Czechia, 140 59 Bata HospitalZlin, Czechia, 762 75|Aarhus N, Denmark, 8200 Herlev HospitalHerlev, Denmark, 2730 H:S RigshospitaletKÃ¸benhavn, Denmark, 2100|Helsinki, Finland, 00180|Besancon, France, 25030 HÃ´pital Saint AndrÃ© - BordeauxBordeaux, France, 33000 Centre De Lutte Contre Le Cancer FranÃ§ois BaclesseCaen Cedex 5, France, 14076 Centre Jean PerrinClermont Ferrand Cedex 1, France, 63011 Centre Oscar Lambret - LilleLille Cedex, France, 59020 Centre LÃ©on BÃ©rardLyon Cedex, France, 69008 Institut Paoli-Calmettes - MarseilleMarseille, France, 13273 Cochin - ParisParis, France, 75674 HÃ´pital D'Instruction Des ArmÃ©es BeginSaint Mande, France, 94160 Clinique Saint AnneStrasbourg, France, 67000 Centre MÃ©dico-Chirurgical FochSuresnes, France, 92151|TÃ¼bingen, Baden-WÃ¼rttemberg, Germany, 72076|DÃ¼sseldorf, Nordrhein-Westfalen, Germany, 40225|Mainz, Rheinland-Pfalz, Germany, 55131 Hong Kong Prince Of Wales HospitalShatin, Hong Kong|Budapest, Hungary, 1062 Orszagos Onkologiai IntezetBudapest, Hungary, 1122 Pecsi Tudomanyegyetem Klinikai KozpontPecs, Hungary, 7624|Cork, Ireland AmnchDublin, Ireland, 24|Haifa, Israel, 3109601 Hadassah Hebrew University Hospital Ein KeremJerusalem, Israel, 9112001 Meir Medical CenterKfar Saba, Israel, 4428164 Clalit Health Services Through Rabin Medical Center - Beilinson CampusPetah Tikva, Israel, 4941492 Chaim Sheba Medical CenterRamat Gan, Israel, 5266202|ForlÃ¬-Cesena, Emilia-Romagna, Italy, 47014 Ausl ModenaModena, Emilia-Romagna, Italy, 41012 A.O.U. Di Modena - PoliclinicoModena, Emilia-Romagna, Italy, 41124|Roma, Lazio, Italy, 00152 Fondazione Policlinico Universitario Agostino Gemelli IrccsRoma, Lazio, Italy, 00168|Milano, Lombardia, Italy, 20133 Irccs Istituto Europeo Di Oncologia (Ieo)Milano, Lombardia, Italy, 20141 Asst Grande Ospedale Metropolitano NiguardaMilano, Lombardia, Italy, 20162|Torino, Piemonte, Italy, 10043|Pisa, Toscana, Italy, 56126|Verona, Veneto, Italy, 37134|Nagoya, Aichi, Japan, 466-8560|Akita, Japan, 010-8543 Kyushu University HospitalFukuoka, Japan, 812-8582 Hiroshima City Hiroshima Citizens HospitalHiroshima, Japan, 730-8518 Kumamoto University HospitalKumamoto, Japan, 860-8556 Niigata University Medical And Dental HospitalNiigata, Japan, 951-8520 Osaka International Cancer InstituteOsaka, Japan, 541-8567 Toyama University HospitalToyama, Japan, 930-0194 Korea, Republic Of, Gyeonggido National Cancer CenterGoyang-Si, Gyeonggido, Korea, Republic Of, 410-769 Korea, Republic Of Asan Medical CenterSeoul, Korea, Republic Of, 05505 Samsung Medical CenterSeoul, Korea, Republic Of, 06351 Yonsei University College Of MedicineSeoul, Korea, Republic Of, 120-752|Hirosaki, Aomori, Japan, 036-8563|Maebashi, Gunma, Japan, 371-8511 Gunma Prefectural Cancer CenterOta, Gunma, Japan, 373-8550|Sapporo, Hokkaido, Japan, 060-8543 Hokkaido University HospitalSapporo, Hokkaido, Japan, 060-8648|Kobe, Hyogo, Japan, 650-0047|Tsukuba, Ibaraki, Japan, 305-8576|Morioka, Iwate, Japan, 028-3695|Yokohama, Kanagawa, Japan, 236-0004|Osakasayama, Osaka, Japan, 589-8511|Hidaka, Saitama, Japan, 350-1298|Bunkyo-Ku, Tokyo, Japan, 113-8603 National Cancer Center HospitalChuo-Ku, Tokyo, Japan, 104-0045 The Cancer Institute Hospital Of JfcrKoto-Ku, Tokyo, Japan, 135-8550 Keio University HospitalShinjuku-Ku, Tokyo, Japan, 160-8582|Amsterdam, Netherlands, 1066 Cx Erasmus Medisch CentrumRotterdam, Netherlands, 3075 Ea|Bydgoszcz, Poland, 85-796 Swietokrzyskie Centrum OnkologiiKielce, Poland, 25-734 Przychodnia Lekarska KomedKonin, Poland, 62-500 Samodzielny Publiczny Zespol Gruzlicy I Chorob PlucOlsztyn, Poland, 10-357 Szpital Kliniczny Przemienienia PanskiegoPoznan, Poland, 60-569 Uniwersytecki Szpital Kliniczny Um We WroclawiuWroclaw, Poland, 50-556|Coimbra, Portugal, 3000-075 Hospital Cuf Infante SantoLisboa, Portugal, 1350-070 Chuln - Hospital Santa MariaLisboa, Portugal, 1649-035 Chup - Hospital Santo AntonioPorto, Portugal, 4099-001 Russian Federation Krasnoyarsk Regional Clinical Oncology DispensaryKrasnoyarsk, Russian Federation, 660133 Moscow Scient. Res. Institute Of Oncology N.A P.A. HertzenMoscow, Russian Federation, 125284 Urological Center PomcNizhny Novgorod, Russian Federation, 603109 Clinical Oncological Dispensary Of Omsk RegionOmsk, Russian Federation, 644013 Bashkir State Medical UniversityUfa, Russian Federation, 450008|Loures, Lisboa, Portugal, 2674-514|Bratislava, Slovakia, 833 10 Uroexam, Spol. S R.O.Nitra, Slovakia, 949 01 Poko Poprad S.R.O.Poprad, Slovakia, 085 01|CÃ³rdoba, AndalucÃ­a, Spain, 14004|Badalona, Barcelona, Spain, 08916 Institut CatalÃ  D'Oncologia HospitaletL'Hospitalet De Llobregat, Barcelona, Spain, 08907|Barcelona, Catalunya, Spain, 08003|Barcelona, Spain, 08035 Hospital San Pedro De AlcÃ¡ntaraCÃ¡ceres, Spain, 10003 Hospital RamÃ³n Y CajalMadrid, Spain, 28034 Hospital Universitario 12 De OctubreMadrid, Spain, 28041 Hospital Virgen De La VictoriaMÃ¡laga, Spain, 29010 Instituto Valenciano De OncologÃ­aValencia, Spain, 46009 Hospital General Universitario De ValenciaValencia, Spain, 46014|Palma De Mallorca, Illes Baleares, Spain, 07120|Stockholm, Sweden, 118 83 Karolinska InstitutetStockholm, Sweden, 17167|Basel, Basel-Stadt, Switzerland, 4031|Chur, GraubÃ¼nden, Switzerland, 7000|St. Gallen, Sankt Gallen, Switzerland, 9007 Taiwan Taichung Veterans General HospitalTaichung, Taiwan, 40705 National Cheng Kung University HospitalTainan, Taiwan National Taiwan University HospitalTaipei, Taiwan, 10002 Taipei Veterans General HospitalTaipei, Taiwan, 11217 Chang Gung Memorial Hospital At LinkouTaoyuan, Taiwan, 333|Bebington, Merseyside, United Kingdom, Ch63 4Jy|London, United Kingdom, Sw3 6Jj|Anchorage, Alaska, United States, 99503|Tucson, Arizona, United States, 85719|Los Angeles, California, United States, 90033 Uc Davis Comprehensive Cancer CenterSacramento, California, United States, 95817 Sansum ClinicSanta Barbara, California, United States, 93105|Littleton, Colorado, United States, 80120-4413|Orlando, Florida, United States, 32806|Westwood, Kansas, United States, 66205|Las Vegas, Nevada, United States, 89169|Tigard, Oregon, United States, 97223|Pittsburgh, Pennsylvania, United States, 15232|Greenville, South Carolina, United States, 29607|Denton, Texas, United States, 76210 Houston Methodist HospitalHouston, Texas, United States, 77030-2707|Seattle, Washington, United States, 98101 Summit Cancer CenterSpokane, Washington, United States, 99208","Alaska|Arizona|California|Colorado|Florida|Kansas|Nevada|Oregon|Pennsylvania|South Carolina|Texas|Washington","Australia|Austria|Belgium|Canada|China|Czechia|Denmark|Finland|France|Germany|Hungary|Ireland|Israel|Italy|Japan|Netherlands|Poland|Portugal|Slovakia|Spain|Sweden|Switzerland|United Kingdom|United States","New South Wales Mid North Coast Cancer Institute|Queensland Pindara Private Hospital|Victoria Monash Medical Centre|Landesklinikum Krems|Uz Gent|Ontario Princess Margaret Hospital-University Health Network|Ottawa Hospital-General Campus|Quebec Sir Mortimer B. Davis Jewish General Hospital|Fifth Medical Center, General Hospital Of The Chinese People|Fujian Fujian Medical University Union Hospital|Guangdong Sun Yat-Sen University Cancer Center|Hubei Hubei Cancer Hospital|Jiangsu Nj Drum Tower Hospital, The Affil Hos Of Nj Univ Med School|Liaoning Liaoning Cancer Hospital And Institute|Fakultni Nemocnice Ostrava|Aarhus Universitetshospital, Skejby|Docrates Klinikka|Hopital Jean Minjoz|Baden-WÃ¼rttemberg Eberhard-Karls-UniversitÃ¤t TÃ¼bingen|Nordrhein-Westfalen Heinrich-Heine-UniversitÃ¤t DÃ¼sseldorf|Rheinland-Pfalz UniversitÃ¤tsmedizin Der Johannes Gutenberg UniversitÃ¤t Mainz|Mh Egeszsegugyi Kozpont|Cork University Hospital|Rambam Health Corporation|Emilia-Romagna Irst Istituto Scientifico Romagnolo Per Studio E Cura Tumori|Lazio A.O. San Camillo-Forlanini|Lombardia Fondazione Irccs Istituto Nazionale Dei Tumori|Piemonte A.O.U. San Luigi Gonzaga|Toscana A.O.U. Pisana|Veneto A.O.U.I. Verona|Aichi Nagoya University Hospital|Akita University Hospital|Aomori Hirosaki University Hospital|Gunma Gunma University Hospital|Hokkaido Sapporo Medical University Hospital|Hyogo Kobe City Medical Center General Hospital|Ibaraki University Of Tsukuba Hospital|Iwate Iwate Medical University Hospital|Kanagawa Yokohama City University Hospital|Osaka Kindai University Hospital|Saitama Saitama Medical University International Medical Center|Tokyo Nippon Medical School Hospital|Nederlands Kanker Instituut|Centrum Onkologii Im. Prof. Franciszka Lukaszczyka|Ipo Coimbra|Lisboa Hospital Beatriz Angelo|Narodny Onkologicky Ustav|AndalucÃ­a Hospital Reina SofÃ­a|Barcelona Institut CatalÃ  D'Oncologia Badalona|Catalunya Hospital Del Mar|Ciutat SanitÃ ria I Universitaria De La Vall D'Hebron|Illes Baleares Hospital Universitari Son Espases|SÃ¶dersjukhuset|Basel-Stadt UniversitÃ¤tsspital Basel|GraubÃ¼nden Kantonsspital GraubÃ¼nden|Sankt Gallen Kantonsspital St. Gallen|, Merseyside Clatterbridge Centre For Oncology|Royal Marsden Hospital (London)|Alaska Clinical Research Center, Llc|University Of Arizona Cancer Center|University Of Southern California|Rocky Mountain Cancer Centers|Uf Cancer Center At Orlando Health|University Of Kansas Medical Center|Comprehensive Cancer Centers Of Nevada|Compass Oncology|University Of Pittsburgh|Bon Secours St. Francis Hospital|Texas Oncology-Denton South|Virginia Mason Medical Center",{"$nulls":3},"Bayer Study Director","2020-04-16","2020-05-25T16:38:42.497","2020-05-26T17:10:42.972","NCT03410693"]
["5ecbf494307e3d1b1f8d9ddf","NCT03410992","2018-02-07","UCB","UCBJF","Recruiting","A Study With a Initial Treatment Period Followed by a Randomized-withdrawal Period to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis (BE READY)","Bimekizumab","IL17A Inhibitor","Yes","['Bimekizumab']","No",null,"Phase 3",2,400,"Anticipated","2018-02-05","2019-02-02","PASI","Psoriasis Area and Severity Index",{"$nulls":3},"Phase 3 study to compare the efficacy of bimekizumab versus placebo in the treatment of subjects with moderate to severe chronic plaque psoriasis.",null,"A Phase 3, Multicenter, Double-Blind, Placebo-Controlled Study With an Initial Treatment Period Followed by a Randomized-Withdrawal Period to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis","PS0013","Chronic Plaque Psoriasis\nModerate to Severe Chronic Plaque Psoriasis\nPsoriatic Arthritis","Arthritis|Psoriasis|Arthritis, Psoriatic","Joint Diseases|Dermatological Diseases|Bone Diseases","Musculoskeletal|Derm & Connective Tissue Disorders","Experimental|Placebo Comparator","Bimekizumab cohort|Placebo","Subjects will receive bimekizumab for 16 Weeks. Subjects who achieve certain predefined response criteria will be re-randomized to either receive bimekizumab or placebo until Week 56. Subjects who do not achieve predefined response criteria will enter the bimekizumab escape arm.|Subjects will receive placebo for 16 Weeks. Subjects who achieve certain predefined response criteria will proceed with placebo until Week 56. Subjects who do not achieve certain predefined response criteria will be re-randomized into the bimekizumab escape arm.","Drug","Bimekizumab|Placebo","Bimekizumab will be provided at pre-specified time intervals.|Subjects will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products.","UCB4940\nPlaceboSubjects will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products.|PBO","Bimekizumab cohort|Placebo","\n\n * Must be at least 18 years of age\n * Chronic plaque psoriasis (PSO) for at least 6 months prior to the Screening Visit\n * Psoriasis Area Severity Index (PASI) >=12 and body surface area (BSA) affected by PSO >=10% and Investigator's Global Assessment (IGA) score >=3 on a 5-point scale\n * Subject is a candidate for systemic PSO therapy\n * Female subject of child bearing potential must be willing to use highly effective method of contraception\n\n","\n\n * Subject has an active infection (except common cold), a recent serious infection, or a history of opportunistic, recurrent, or chronic infections\n * Subject has concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection\n * Subject has known tuberculosis (TB) infection, is at high risk of acquiring TB infection, or has current or history of nontuberculous mycobacterium (NTMB) infection\n * Subject has any other condition, including medical or psychiatric, which, in the Investigator's judgment, would make the subject unsuitable for inclusion in the study\n * Presence of active suicidal ideation or severe depression\n * Subject has concurrent or a recent history (<5 years) of malignancy",{"$nulls":4},"Actual","2018-01-25","Actual","Anticipated","2020-02-29","Anticipated","2018-02-01","2018-01-19","2018-01-19","2018-02-06","Yes","Bimekizumab\nPSO\nPsoriasis","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"All",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2016-003426-16","EudraCT Number","Psoriasis Area and Severity Index 90 (PASI90) response at Week 16|Investigator's Global Assessment (IGA) response at Week 16","A PASI90 responder is defined as a subject that achieves 90% reduction from Baseline in the PASI score.|IGA response is defined as Clear or Almost Clear with at least a 2-category improvement relative to Baseline.","Week 16","PASI100 response at Week 16|PASI75 response at Week 4|Change from Baseline in the Patient Symptom Diary responses for itch at Week 16|Change from Baseline in the Patient Symptom Diary responses for pain at Week 16|Change from Baseline in the Patient Symptom Diary responses for scaling at Week 16|IGA response (Clear or Almost Clear) at Week 16 for subjects with scalp psoriasis (PSO) at Baseline|PASI90 response at Week 56 among Week 16 PASI90 responders|Number of Treatment Emergent Adverse Events (TEAEs) adjusted by duration of subject exposure to study treatment|Number of Serious Adverse Events (SAEs) adjusted by duration of subject exposure to study treatment|Number of TEAEs leading to withdrawal adjusted by duration of subject exposure to study treatment","A PASI100 responder is defined as a subject that achieves 100% reduction from Baseline in the PASI score.|A PASI75 responder is defined as a subject that achieves 75% reduction from Baseline in the PASI score.|A Patient-Reported outcome (PRO) measure will be used to assess key symptoms relevant to patients with moderate to severe chronic plaque PSO. Site staff will train the participating subjects on the use of the electronic PRO (ePRO) diary at the Screening Visit, following which the device will be dispensed to the subject for home use until the Week 16 Visit. The ePRO diary will be administered on a daily basis from Screening to the Week 16 Visit.|A PRO measure will be used to assess key symptoms relevant to patients with moderate to severe chronic plaque PSO. Site staff will train the participating subjects on the use of the electronic PRO (ePRO) diary at the Screening Visit, following which the device will be dispensed to the subject for home use until the Week 16 Visit. The ePRO diary will be administered on a daily basis from Screening to the Week 16 Visit.|Only subjects with scalp involvement at Baseline will complete the scalp IGA. Subjects with scalp involvement at Baseline are defined as those with a scalp IGA score >0 at Baseline. Scalp lesions will be assessed in terms of clinical signs of redness, thickness, and scaliness using a 5-point scale (0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, 4= Severe).|A PASI90 responder is defined as a subject that achieves 90% reduction from Baseline in the PASI score.|The number of TEAEs adjusted by duration of exposure to study treatment is scaled such that it provides an incidence rate per 100 patient-years. If a subject has multiple events, the time of exposure is calculated to the first occurrence of the Adverse Event (AE) being considered. If a subject has no events, the total time at risk is used.|The number of SAEs adjusted by duration of exposure to study treatment is scaled such that it provides an incidence rate per 100 patient-years. If a subject has multiple events, the time of exposure is calculated to the first occurrence of the AE being considered. If a subject has no events, the total time at risk is used.|The number of TEAEs leading to discontinuation adjusted by duration of exposure to study treatment is scaled such that it provides an incidence rate per 100 patient-years. If a subject has multiple events, the time of exposure is calculated to the first occurrence of the AE being considered. If a subject has no events, the total time at risk is used.","Week 16|Week 4|Week 56|From Screening to Safety Follow Up (up to Week 76)","UCBCares@ucb.com","UCB Cares","+1844599 Ext. 2273","Portland, Oregon, United States, 97223","Oregon","United States","Ps0013 929",{"$nulls":3},"UCB Cares","2018-02-06","2020-05-25T16:38:44.095","2020-05-26T17:10:42.972","NCT03410992"]
["5ecbf494307e3d1b1f8d9de0","NCT03410992","2018-02-19","UCB","UCBJF","Recruiting","A Study With a Initial Treatment Period Followed by a Randomized-withdrawal Period to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis (BE READY)","Bimekizumab","IL17A Inhibitor","Yes","['Bimekizumab']","No",null,"Phase 3",2,400,"Anticipated","2018-02-05","2019-02-01","PASI","Psoriasis Area and Severity Index",{"$nulls":3},"Phase 3 study to compare the efficacy of bimekizumab versus placebo in the treatment of subjects with moderate to severe chronic plaque psoriasis.",null,"A Phase 3, Multicenter, Double-Blind, Placebo-Controlled Study With an Initial Treatment Period Followed by a Randomized-Withdrawal Period to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis","PS0013","Chronic Plaque Psoriasis\nModerate to Severe Chronic Plaque Psoriasis\nPsoriatic Arthritis","Arthritis|Psoriasis|Arthritis, Psoriatic","Joint Diseases|Dermatological Diseases|Bone Diseases","Musculoskeletal|Derm & Connective Tissue Disorders","Experimental|Placebo Comparator","Bimekizumab cohort|Placebo","Subjects will receive bimekizumab for 16 Weeks. Subjects who achieve certain predefined response criteria will be re-randomized to either receive bimekizumab or placebo until Week 56. Subjects who do not achieve predefined response criteria will enter the bimekizumab escape arm.|Subjects will receive placebo for 16 Weeks. Subjects who achieve certain predefined response criteria will proceed with placebo until Week 56. Subjects who do not achieve certain predefined response criteria will be re-randomized into the bimekizumab escape arm.","Drug","Bimekizumab|Placebo","Bimekizumab will be provided at pre-specified time intervals.|Subjects will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products.","UCB4940\nPlaceboSubjects will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products.|PBO","Bimekizumab cohort|Placebo","\n\n * Must be at least 18 years of age\n * Chronic plaque psoriasis (PSO) for at least 6 months prior to the Screening Visit\n * Psoriasis Area Severity Index (PASI) >=12 and body surface area (BSA) affected by PSO >=10% and Investigator's Global Assessment (IGA) score >=3 on a 5-point scale\n * Subject is a candidate for systemic PSO therapy\n * Female subject of child bearing potential must be willing to use highly effective method of contraception\n\n","\n\n * Subject has an active infection (except common cold), a recent serious infection, or a history of opportunistic, recurrent, or chronic infections\n * Subject has concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection\n * Subject has known tuberculosis (TB) infection, is at high risk of acquiring TB infection, or has current or history of nontuberculous mycobacterium (NTMB) infection\n * Subject has any other condition, including medical or psychiatric, which, in the Investigator's judgment, would make the subject unsuitable for inclusion in the study\n * Presence of active suicidal ideation or severe depression\n * Subject has concurrent or a recent history (<5 years) of malignancy",{"$nulls":4},"Actual","2018-01-25","Actual","Anticipated","2020-02-01","Anticipated","2018-02-01","2018-01-19","2018-01-19","2018-02-15","Yes","Bimekizumab\nPSO\nPsoriasis","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"All",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2016-003426-16","EudraCT Number","Psoriasis Area and Severity Index 90 (PASI90) response at Week 16|Investigator's Global Assessment (IGA) response at Week 16","A PASI90 responder is defined as a subject that achieves 90% reduction from Baseline in the PASI score.|IGA response is defined as Clear or Almost Clear with at least a 2-category improvement relative to Baseline.","Week 16","PASI100 response at Week 16|PASI75 response at Week 4|Change from Baseline in the Patient Symptom Diary responses for itch at Week 16|Change from Baseline in the Patient Symptom Diary responses for pain at Week 16|Change from Baseline in the Patient Symptom Diary responses for scaling at Week 16|IGA response (Clear or Almost Clear) at Week 16 for subjects with scalp psoriasis (PSO) at Baseline|PASI90 response at Week 56 among Week 16 PASI90 responders|Number of Treatment Emergent Adverse Events (TEAEs) adjusted by duration of subject exposure to study treatment|Number of Serious Adverse Events (SAEs) adjusted by duration of subject exposure to study treatment|Number of TEAEs leading to withdrawal adjusted by duration of subject exposure to study treatment","A PASI100 responder is defined as a subject that achieves 100% reduction from Baseline in the PASI score.|A PASI75 responder is defined as a subject that achieves 75% reduction from Baseline in the PASI score.|A Patient-Reported outcome (PRO) measure will be used to assess key symptoms relevant to patients with moderate to severe chronic plaque PSO. Site staff will train the participating subjects on the use of the electronic PRO (ePRO) diary at the Screening Visit, following which the device will be dispensed to the subject for home use until the Week 16 Visit. The ePRO diary will be administered on a daily basis from Screening to the Week 16 Visit.|A PRO measure will be used to assess key symptoms relevant to patients with moderate to severe chronic plaque PSO. Site staff will train the participating subjects on the use of the electronic PRO (ePRO) diary at the Screening Visit, following which the device will be dispensed to the subject for home use until the Week 16 Visit. The ePRO diary will be administered on a daily basis from Screening to the Week 16 Visit.|Only subjects with scalp involvement at Baseline will complete the scalp IGA. Subjects with scalp involvement at Baseline are defined as those with a scalp IGA score >0 at Baseline. Scalp lesions will be assessed in terms of clinical signs of redness, thickness, and scaliness using a 5-point scale (0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, 4= Severe).|A PASI90 responder is defined as a subject that achieves 90% reduction from Baseline in the PASI score.|The number of TEAEs adjusted by duration of exposure to study treatment is scaled such that it provides an incidence rate per 100 patient-years. If a subject has multiple events, the time of exposure is calculated to the first occurrence of the Adverse Event (AE) being considered. If a subject has no events, the total time at risk is used.|The number of SAEs adjusted by duration of exposure to study treatment is scaled such that it provides an incidence rate per 100 patient-years. If a subject has multiple events, the time of exposure is calculated to the first occurrence of the AE being considered. If a subject has no events, the total time at risk is used.|The number of TEAEs leading to discontinuation adjusted by duration of exposure to study treatment is scaled such that it provides an incidence rate per 100 patient-years. If a subject has multiple events, the time of exposure is calculated to the first occurrence of the AE being considered. If a subject has no events, the total time at risk is used.","Week 16|Week 4|Week 56|From Screening to Safety Follow Up (up to Week 76)","UCBCares@ucb.com","UCB Cares","+1844599 Ext. 2273","Portland, Oregon, United States, 97223|San Antonio, Texas, United States, 78213","Oregon|Texas","United States","Ps0013 929|Ps0013 914",{"$nulls":3},"UCB Cares","2018-02-15","2020-05-25T16:38:44.256","2020-05-26T17:10:42.972","NCT03410992"]
["5ecbf494feab101b1553097e","NCT03410992","2018-05-11","UCB","UCBJF","Recruiting","A Study With a Initial Treatment Period Followed by a Randomized-withdrawal Period to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis (BE READY)","Bimekizumab","IL17A Inhibitor","Yes","['Bimekizumab']","No",null,"Phase 3",2,400,"Anticipated","2018-02-05","2019-02-01","PASI","Psoriasis Area and Severity Index",{"$nulls":3},"Phase 3 study to compare the efficacy of bimekizumab versus placebo in the treatment of subjects with moderate to severe chronic plaque psoriasis.",null,"A Phase 3, Multicenter, Double-Blind, Placebo-Controlled Study With an Initial Treatment Period Followed by a Randomized-Withdrawal Period to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis","PS0013","Chronic Plaque Psoriasis\nModerate to Severe Chronic Plaque Psoriasis\nPsoriatic Arthritis","Arthritis|Psoriasis|Arthritis, Psoriatic","Joint Diseases|Dermatological Diseases|Bone Diseases","Musculoskeletal|Derm & Connective Tissue Disorders","Experimental|Placebo Comparator","Bimekizumab cohort|Placebo","Subjects will receive bimekizumab for 16 Weeks. Subjects who achieve certain predefined response criteria will be re-randomized to either receive bimekizumab or placebo until Week 56. Subjects who do not achieve predefined response criteria will enter the bimekizumab escape arm.|Subjects will receive placebo for 16 Weeks. Subjects who achieve certain predefined response criteria will proceed with placebo until Week 56. Subjects who do not achieve certain predefined response criteria will be re-randomized into the bimekizumab escape arm.","Drug","Bimekizumab|Placebo","Bimekizumab will be provided at pre-specified time intervals.|Subjects will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products.","UCB4940\nPlaceboSubjects will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products.|PBO","Bimekizumab cohort|Placebo","\n\n * Must be at least 18 years of age\n * Chronic plaque psoriasis (PSO) for at least 6 months prior to the Screening Visit\n * Psoriasis Area Severity Index (PASI) >=12 and body surface area (BSA) affected by PSO >=10% and Investigator's Global Assessment (IGA) score >=3 on a 5-point scale\n * Subject is a candidate for systemic PSO therapy\n * Female subject of child bearing potential must be willing to use highly effective method of contraception\n\n","\n\n * Subject has an active infection (except common cold), a recent serious infection, or a history of opportunistic, recurrent, or chronic infections\n * Subject has concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection\n * Subject has known tuberculosis (TB) infection, is at high risk of acquiring TB infection, or has current or history of nontuberculous mycobacterium (NTMB) infection\n * Subject has any other condition, including medical or psychiatric, which, in the Investigator's judgment, would make the subject unsuitable for inclusion in the study\n * Presence of active suicidal ideation or severe depression\n * Subject has concurrent or a recent history (<5 years) of malignancy",{"$nulls":4},"Actual","2018-01-25","Actual","Anticipated","2020-02-01","Anticipated","2018-05-01","2018-01-19","2018-01-19","2018-05-10","Yes","Bimekizumab\nPSO\nPsoriasis","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"All",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2016-003426-16","EudraCT Number","Psoriasis Area and Severity Index 90 (PASI90) response at Week 16|Investigator's Global Assessment (IGA) response at Week 16","A PASI90 responder is defined as a subject that achieves 90% reduction from Baseline in the PASI score.|IGA response is defined as Clear or Almost Clear with at least a 2-category improvement relative to Baseline.","Week 16","PASI100 response at Week 16|PASI75 response at Week 4|Change from Baseline in the Patient Symptom Diary responses for itch at Week 16|Change from Baseline in the Patient Symptom Diary responses for pain at Week 16|Change from Baseline in the Patient Symptom Diary responses for scaling at Week 16|IGA response (Clear or Almost Clear) at Week 16 for subjects with scalp psoriasis (PSO) at Baseline|PASI90 response at Week 56 among Week 16 PASI90 responders|Number of Treatment Emergent Adverse Events (TEAEs) adjusted by duration of subject exposure to study treatment|Number of Serious Adverse Events (SAEs) adjusted by duration of subject exposure to study treatment|Number of TEAEs leading to withdrawal adjusted by duration of subject exposure to study treatment","A PASI100 responder is defined as a subject that achieves 100% reduction from Baseline in the PASI score.|A PASI75 responder is defined as a subject that achieves 75% reduction from Baseline in the PASI score.|A Patient-Reported outcome (PRO) measure will be used to assess key symptoms relevant to patients with moderate to severe chronic plaque PSO. Site staff will train the participating subjects on the use of the electronic PRO (ePRO) diary at the Screening Visit, following which the device will be dispensed to the subject for home use until the Week 16 Visit. The ePRO diary will be administered on a daily basis from Screening to the Week 16 Visit.|A PRO measure will be used to assess key symptoms relevant to patients with moderate to severe chronic plaque PSO. Site staff will train the participating subjects on the use of the electronic PRO (ePRO) diary at the Screening Visit, following which the device will be dispensed to the subject for home use until the Week 16 Visit. The ePRO diary will be administered on a daily basis from Screening to the Week 16 Visit.|Only subjects with scalp involvement at Baseline will complete the scalp IGA. Subjects with scalp involvement at Baseline are defined as those with a scalp IGA score >0 at Baseline. Scalp lesions will be assessed in terms of clinical signs of redness, thickness, and scaliness using a 5-point scale (0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, 4= Severe).|A PASI90 responder is defined as a subject that achieves 90% reduction from Baseline in the PASI score.|The number of TEAEs adjusted by duration of exposure to study treatment is scaled such that it provides an incidence rate per 100 patient-years. If a subject has multiple events, the time of exposure is calculated to the first occurrence of the Adverse Event (AE) being considered. If a subject has no events, the total time at risk is used.|The number of SAEs adjusted by duration of exposure to study treatment is scaled such that it provides an incidence rate per 100 patient-years. If a subject has multiple events, the time of exposure is calculated to the first occurrence of the AE being considered. If a subject has no events, the total time at risk is used.|The number of TEAEs leading to discontinuation adjusted by duration of exposure to study treatment is scaled such that it provides an incidence rate per 100 patient-years. If a subject has multiple events, the time of exposure is calculated to the first occurrence of the AE being considered. If a subject has no events, the total time at risk is used.","Week 16|Week 4|Week 56|From Screening to Safety Follow Up (up to Week 76)","UCBCares@ucb.com","UCB Cares","+1844599 Ext. 2273","Ajax, Canada Ps0013 671Hamilton, Canada Ps0013 663Mississauga, Canada Ps0013 668North Bay, Canada|San Diego, California, United States, 92103 Ps0013 967Santa Monica, California, United States, 90404|Fort Myers, Florida, United States, 33912|Sandy Springs, Georgia, United States, 30329|Skokie, Illinois, United States, 60077|Owensboro, Kentucky, United States, 42303|New Orleans, Louisiana, United States, 70115|Beverly, Massachusetts, United States, 01915|Portsmouth, New Hampshire, United States, 03801|Verona, New Jersey, United States, 07044-2946|Buffalo, New York, United States, 14221 Ps0013 965New York, New York, United States, 10025 Ps0013 963Rochester, New York, United States, 14623|Portland, Oregon, United States, 97223|Johnston, Rhode Island, United States, 02919|San Antonio, Texas, United States, 78213","California|Florida|Georgia|Illinois|Kentucky|Louisiana|Massachusetts|New Hampshire|New Jersey|New York|Oregon|Rhode Island|Texas","Canada|United States","Ps0013 658|Ps0013 919|Ps0013 928|Ps0013 966|Ps0013 954|Ps0013 962|Ps0013 944|Ps0013 940|Ps0013 901|Ps0013 956|Ps0013 947|Ps0013 929|Ps0013 937|Ps0013 914",{"$nulls":3},"UCB Cares","2018-05-10","2020-05-25T16:38:44.380","2020-05-26T17:10:42.972","NCT03410992"]
["5ecbf49411702c1b1b916b5d","NCT03410992","2018-05-25","UCB","UCBJF","Recruiting","A Study With a Initial Treatment Period Followed by a Randomized-withdrawal Period to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis (BE READY)","Bimekizumab","IL17A Inhibitor","Yes","['Bimekizumab']","No",null,"Phase 3",2,400,"Anticipated","2018-02-05","2019-02-01","PASI","Psoriasis Area and Severity Index",{"$nulls":3},"Phase 3 study to compare the efficacy of bimekizumab versus placebo in the treatment of subjects with moderate to severe chronic plaque psoriasis.",null,"A Phase 3, Multicenter, Double-Blind, Placebo-Controlled Study With an Initial Treatment Period Followed by a Randomized-Withdrawal Period to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis","PS0013","Chronic Plaque Psoriasis\nModerate to Severe Chronic Plaque Psoriasis\nPsoriatic Arthritis","Arthritis|Psoriasis|Arthritis, Psoriatic","Joint Diseases|Dermatological Diseases|Bone Diseases","Musculoskeletal|Derm & Connective Tissue Disorders","Experimental|Placebo Comparator","Bimekizumab cohort|Placebo","Subjects will receive bimekizumab for 16 Weeks. Subjects who achieve certain predefined response criteria will be re-randomized to either receive bimekizumab or placebo until Week 56. Subjects who do not achieve predefined response criteria will enter the bimekizumab escape arm.|Subjects will receive placebo for 16 Weeks. Subjects who achieve certain predefined response criteria will proceed with placebo until Week 56. Subjects who do not achieve certain predefined response criteria will be re-randomized into the bimekizumab escape arm.","Drug","Bimekizumab|Placebo","Bimekizumab will be provided at pre-specified time intervals.|Subjects will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products.","UCB4940\nPlaceboSubjects will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products.|PBO","Bimekizumab cohort|Placebo","\n\n * Must be at least 18 years of age\n * Chronic plaque psoriasis (PSO) for at least 6 months prior to the Screening Visit\n * Psoriasis Area Severity Index (PASI) >=12 and body surface area (BSA) affected by PSO >=10% and Investigator's Global Assessment (IGA) score >=3 on a 5-point scale\n * Subject is a candidate for systemic PSO therapy\n * Female subject of child bearing potential must be willing to use highly effective method of contraception\n\n","\n\n * Subject has an active infection (except common cold), a recent serious infection, or a history of opportunistic, recurrent, or chronic infections\n * Subject has concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection\n * Subject has known tuberculosis (TB) infection, is at high risk of acquiring TB infection, or has current or history of nontuberculous mycobacterium (NTMB) infection\n * Subject has any other condition, including medical or psychiatric, which, in the Investigator's judgment, would make the subject unsuitable for inclusion in the study\n * Presence of active suicidal ideation or severe depression\n * Subject has concurrent or a recent history (<5 years) of malignancy",{"$nulls":4},"Actual","2018-01-25","Actual","Anticipated","2020-02-01","Anticipated","2018-05-01","2018-01-19","2018-01-19","2018-05-24","Yes","Bimekizumab\nPSO\nPsoriasis","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"All",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2016-003426-16","EudraCT Number","Psoriasis Area and Severity Index 90 (PASI90) response at Week 16|Investigator's Global Assessment (IGA) response at Week 16","A PASI90 responder is defined as a subject that achieves 90% reduction from Baseline in the PASI score.|IGA response is defined as Clear or Almost Clear with at least a 2-category improvement relative to Baseline.","Week 16","PASI100 response at Week 16|PASI75 response at Week 4|Change from Baseline in the Patient Symptom Diary responses for itch at Week 16|Change from Baseline in the Patient Symptom Diary responses for pain at Week 16|Change from Baseline in the Patient Symptom Diary responses for scaling at Week 16|IGA response (Clear or Almost Clear) at Week 16 for subjects with scalp psoriasis (PSO) at Baseline|PASI90 response at Week 56 among Week 16 PASI90 responders|Number of Treatment Emergent Adverse Events (TEAEs) adjusted by duration of subject exposure to study treatment|Number of Serious Adverse Events (SAEs) adjusted by duration of subject exposure to study treatment|Number of TEAEs leading to withdrawal adjusted by duration of subject exposure to study treatment","A PASI100 responder is defined as a subject that achieves 100% reduction from Baseline in the PASI score.|A PASI75 responder is defined as a subject that achieves 75% reduction from Baseline in the PASI score.|A Patient-Reported outcome (PRO) measure will be used to assess key symptoms relevant to patients with moderate to severe chronic plaque PSO. Site staff will train the participating subjects on the use of the electronic PRO (ePRO) diary at the Screening Visit, following which the device will be dispensed to the subject for home use until the Week 16 Visit. The ePRO diary will be administered on a daily basis from Screening to the Week 16 Visit.|A PRO measure will be used to assess key symptoms relevant to patients with moderate to severe chronic plaque PSO. Site staff will train the participating subjects on the use of the electronic PRO (ePRO) diary at the Screening Visit, following which the device will be dispensed to the subject for home use until the Week 16 Visit. The ePRO diary will be administered on a daily basis from Screening to the Week 16 Visit.|Only subjects with scalp involvement at Baseline will complete the scalp IGA. Subjects with scalp involvement at Baseline are defined as those with a scalp IGA score >0 at Baseline. Scalp lesions will be assessed in terms of clinical signs of redness, thickness, and scaliness using a 5-point scale (0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, 4= Severe).|A PASI90 responder is defined as a subject that achieves 90% reduction from Baseline in the PASI score.|The number of TEAEs adjusted by duration of exposure to study treatment is scaled such that it provides an incidence rate per 100 patient-years. If a subject has multiple events, the time of exposure is calculated to the first occurrence of the Adverse Event (AE) being considered. If a subject has no events, the total time at risk is used.|The number of SAEs adjusted by duration of exposure to study treatment is scaled such that it provides an incidence rate per 100 patient-years. If a subject has multiple events, the time of exposure is calculated to the first occurrence of the AE being considered. If a subject has no events, the total time at risk is used.|The number of TEAEs leading to discontinuation adjusted by duration of exposure to study treatment is scaled such that it provides an incidence rate per 100 patient-years. If a subject has multiple events, the time of exposure is calculated to the first occurrence of the AE being considered. If a subject has no events, the total time at risk is used.","Week 16|Week 4|Week 56|From Screening to Safety Follow Up (up to Week 76)","UCBCares@ucb.com","UCB Cares","+1844599 Ext. 2273","Ajax, Canada Ps0013 671Hamilton, Canada Ps0013 675Markham, Canada Ps0013 663Mississauga, Canada Ps0013 668North Bay, Canada Ps0013 667Ottawa, Canada Ps0013 676Surrey, Canada|Szolnok, Hungary|San Diego, California, United States, 92103 Ps0013 955San Diego, California, United States, 92123 Ps0013 967Santa Monica, California, United States, 90404|Fort Myers, Florida, United States, 33912|Sandy Springs, Georgia, United States, 30329|Skokie, Illinois, United States, 60077|Owensboro, Kentucky, United States, 42303|New Orleans, Louisiana, United States, 70115|Beverly, Massachusetts, United States, 01915|Portsmouth, New Hampshire, United States, 03801|Verona, New Jersey, United States, 07044-2946|Buffalo, New York, United States, 14221 Ps0013 965New York, New York, United States, 10025 Ps0013 963Rochester, New York, United States, 14623|Portland, Oregon, United States, 97223|Johnston, Rhode Island, United States, 02919|San Antonio, Texas, United States, 78213","California|Florida|Georgia|Illinois|Kentucky|Louisiana|Massachusetts|New Hampshire|New Jersey|New York|Oregon|Rhode Island|Texas","Canada|Hungary|United States","Ps0013 658|Ps0013 250|Ps0013 919|Ps0013 928|Ps0013 966|Ps0013 954|Ps0013 962|Ps0013 944|Ps0013 940|Ps0013 901|Ps0013 956|Ps0013 947|Ps0013 929|Ps0013 937|Ps0013 914",{"$nulls":3},"UCB Cares","2018-05-24","2020-05-25T16:38:44.593","2020-05-26T17:10:42.972","NCT03410992"]
["5ecbf494fe30261b1a048350","NCT03410992","2018-06-25","UCB","UCBJF","Recruiting","A Study With a Initial Treatment Period Followed by a Randomized-withdrawal Period to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis (BE READY)","Bimekizumab","IL17A Inhibitor","Yes","['Bimekizumab']","No",null,"Phase 3",2,400,"Anticipated","2018-02-05","2019-02-01","PASI","Psoriasis Area and Severity Index",{"$nulls":3},"Phase 3 study to compare the efficacy of bimekizumab versus placebo in the treatment of subjects with moderate to severe chronic plaque psoriasis.",null,"A Phase 3, Multicenter, Double-Blind, Placebo-Controlled Study With an Initial Treatment Period Followed by a Randomized-Withdrawal Period to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis","PS0013","Chronic Plaque Psoriasis\nModerate to Severe Chronic Plaque Psoriasis\nPsoriatic Arthritis","Arthritis|Psoriasis|Arthritis, Psoriatic","Joint Diseases|Dermatological Diseases|Bone Diseases","Musculoskeletal|Derm & Connective Tissue Disorders","Experimental|Placebo Comparator","Bimekizumab cohort|Placebo","Subjects will receive bimekizumab for 16 Weeks. Subjects who achieve certain predefined response criteria will be re-randomized to either receive bimekizumab or placebo until Week 56. Subjects who do not achieve predefined response criteria will enter the bimekizumab escape arm.|Subjects will receive placebo for 16 Weeks. Subjects who achieve certain predefined response criteria will proceed with placebo until Week 56. Subjects who do not achieve certain predefined response criteria will be re-randomized into the bimekizumab escape arm.","Drug","Bimekizumab|Placebo","Bimekizumab will be provided at pre-specified time intervals.|Subjects will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products.","UCB4940\nPlaceboSubjects will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products.|PBO","Bimekizumab cohort|Placebo","\n\n * Must be at least 18 years of age\n * Chronic plaque psoriasis (PSO) for at least 6 months prior to the Screening Visit\n * Psoriasis Area Severity Index (PASI) >=12 and body surface area (BSA) affected by PSO >=10% and Investigator's Global Assessment (IGA) score >=3 on a 5-point scale\n * Subject is a candidate for systemic PSO therapy\n * Female subject of child bearing potential must be willing to use highly effective method of contraception\n\n","\n\n * Subject has an active infection (except common cold), a recent serious infection, or a history of opportunistic, recurrent, or chronic infections\n * Subject has concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection\n * Subject has known tuberculosis (TB) infection, is at high risk of acquiring TB infection, or has current or history of nontuberculous mycobacterium (NTMB) infection\n * Subject has any other condition, including medical or psychiatric, which, in the Investigator's judgment, would make the subject unsuitable for inclusion in the study\n * Presence of active suicidal ideation or severe depression\n * Subject has concurrent or a recent history (<5 years) of malignancy",{"$nulls":4},"Actual","2018-01-25","Actual","Anticipated","2020-02-01","Anticipated","2018-06-01","2018-01-19","2018-01-19","2018-06-21","Yes","Bimekizumab\nPSO\nPsoriasis","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"All",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2016-003426-16","EudraCT Number","Psoriasis Area and Severity Index 90 (PASI90) response at Week 16|Investigator's Global Assessment (IGA) response at Week 16","A PASI90 responder is defined as a subject that achieves 90% reduction from Baseline in the PASI score.|IGA response is defined as Clear or Almost Clear with at least a 2-category improvement relative to Baseline.","Week 16","PASI100 response at Week 16|PASI75 response at Week 4|Change from Baseline in the Patient Symptom Diary responses for itch at Week 16|Change from Baseline in the Patient Symptom Diary responses for pain at Week 16|Change from Baseline in the Patient Symptom Diary responses for scaling at Week 16|IGA response (Clear or Almost Clear) at Week 16 for subjects with scalp psoriasis (PSO) at Baseline|PASI90 response at Week 56 among Week 16 PASI90 responders|Number of Treatment Emergent Adverse Events (TEAEs) adjusted by duration of subject exposure to study treatment|Number of Serious Adverse Events (SAEs) adjusted by duration of subject exposure to study treatment|Number of TEAEs leading to withdrawal adjusted by duration of subject exposure to study treatment","A PASI100 responder is defined as a subject that achieves 100% reduction from Baseline in the PASI score.|A PASI75 responder is defined as a subject that achieves 75% reduction from Baseline in the PASI score.|A Patient-Reported outcome (PRO) measure will be used to assess key symptoms relevant to patients with moderate to severe chronic plaque PSO. Site staff will train the participating subjects on the use of the electronic PRO (ePRO) diary at the Screening Visit, following which the device will be dispensed to the subject for home use until the Week 16 Visit. The ePRO diary will be administered on a daily basis from Screening to the Week 16 Visit.|A PRO measure will be used to assess key symptoms relevant to patients with moderate to severe chronic plaque PSO. Site staff will train the participating subjects on the use of the electronic PRO (ePRO) diary at the Screening Visit, following which the device will be dispensed to the subject for home use until the Week 16 Visit. The ePRO diary will be administered on a daily basis from Screening to the Week 16 Visit.|Only subjects with scalp involvement at Baseline will complete the scalp IGA. Subjects with scalp involvement at Baseline are defined as those with a scalp IGA score >0 at Baseline. Scalp lesions will be assessed in terms of clinical signs of redness, thickness, and scaliness using a 5-point scale (0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, 4= Severe).|A PASI90 responder is defined as a subject that achieves 90% reduction from Baseline in the PASI score.|The number of TEAEs adjusted by duration of exposure to study treatment is scaled such that it provides an incidence rate per 100 patient-years. If a subject has multiple events, the time of exposure is calculated to the first occurrence of the Adverse Event (AE) being considered. If a subject has no events, the total time at risk is used.|The number of SAEs adjusted by duration of exposure to study treatment is scaled such that it provides an incidence rate per 100 patient-years. If a subject has multiple events, the time of exposure is calculated to the first occurrence of the AE being considered. If a subject has no events, the total time at risk is used.|The number of TEAEs leading to discontinuation adjusted by duration of exposure to study treatment is scaled such that it provides an incidence rate per 100 patient-years. If a subject has multiple events, the time of exposure is calculated to the first occurrence of the AE being considered. If a subject has no events, the total time at risk is used.","Week 16|Week 4|Week 56|From Screening to Safety Follow Up (up to Week 76)","UCBCares@ucb.com","UCB Cares","+1844599 Ext. 2273","Ajax, Canada Ps0013 671Hamilton, Canada Ps0013 675Markham, Canada Ps0013 663Mississauga, Canada Ps0013 660MontrÃ©al, Canada Ps0013 668North Bay, Canada Ps0013 667Ottawa, Canada Ps0013 665QuÃ©bec, Canada Ps0013 676Surrey, Canada Ps0013 657Waterloo, Canada|Miskolc, Hungary Ps0013 253OroshÃ¡za, Hungary Ps0013 250Szolnok, Hungary Ps0013 258VeszprÃ©m, Hungary|BiaÅ‚ystok, Poland Ps0013 358Katowice, Poland Ps0013 350Warsaw, Poland Ps0013 368WrocÅ‚aw, Poland|San Diego, California, United States, 92103 Ps0013 955San Diego, California, United States, 92123 Ps0013 967Santa Monica, California, United States, 90404|Fort Myers, Florida, United States, 33912|Sandy Springs, Georgia, United States, 30329|Skokie, Illinois, United States, 60077|Owensboro, Kentucky, United States, 42303|New Orleans, Louisiana, United States, 70115|Beverly, Massachusetts, United States, 01915|Portsmouth, New Hampshire, United States, 03801|Verona, New Jersey, United States, 07044-2946|Buffalo, New York, United States, 14221 Ps0013 965New York, New York, United States, 10025 Ps0013 963Rochester, New York, United States, 14623|Portland, Oregon, United States, 97223|Johnston, Rhode Island, United States, 02919|San Antonio, Texas, United States, 78213","California|Florida|Georgia|Illinois|Kentucky|Louisiana|Massachusetts|New Hampshire|New Jersey|New York|Oregon|Rhode Island|Texas","Canada|Hungary|Poland|United States","Ps0013 658|Ps0013 262|Ps0013 369|Ps0013 919|Ps0013 928|Ps0013 966|Ps0013 954|Ps0013 962|Ps0013 944|Ps0013 940|Ps0013 901|Ps0013 956|Ps0013 947|Ps0013 929|Ps0013 937|Ps0013 914",{"$nulls":3},"UCB Cares","2018-06-21","2020-05-25T16:38:44.485","2020-05-26T17:10:42.972","NCT03410992"]
["5ecbf494feab101b1553097f","NCT03410992","2018-07-20","UCB","UCBJF","Recruiting","A Study With a Initial Treatment Period Followed by a Randomized-withdrawal Period to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis (BE READY)","Bimekizumab","IL17A Inhibitor","Yes","['Bimekizumab']","No",null,"Phase 3",2,400,"Anticipated","2018-02-05","2019-02-01","PASI","Psoriasis Area and Severity Index",{"$nulls":3},"Phase 3 study to compare the efficacy of bimekizumab versus placebo in the treatment of subjects with moderate to severe chronic plaque psoriasis.",null,"A Phase 3, Multicenter, Double-Blind, Placebo-Controlled Study With an Initial Treatment Period Followed by a Randomized-Withdrawal Period to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis","PS0013","Chronic Plaque Psoriasis\nModerate to Severe Chronic Plaque Psoriasis\nPsoriatic Arthritis","Arthritis|Psoriasis|Arthritis, Psoriatic","Joint Diseases|Dermatological Diseases|Bone Diseases","Musculoskeletal|Derm & Connective Tissue Disorders","Experimental|Placebo Comparator","Bimekizumab cohort|Placebo","Subjects will receive bimekizumab for 16 Weeks. Subjects who achieve certain predefined response criteria will be re-randomized to either receive bimekizumab or placebo until Week 56. Subjects who do not achieve predefined response criteria will enter the bimekizumab escape arm.|Subjects will receive placebo for 16 Weeks. Subjects who achieve certain predefined response criteria will proceed with placebo until Week 56. Subjects who do not achieve certain predefined response criteria will enter the bimekizumab escape arm.","Drug","Bimekizumab|Placebo","Bimekizumab will be provided at pre-specified time intervals.|Subjects will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products.","UCB4940\nPlaceboSubjects will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products.|PBO","Bimekizumab cohort|Placebo","\n\n * Must be at least 18 years of age\n * Chronic plaque psoriasis (PSO) for at least 6 months prior to the Screening Visit\n * Psoriasis Area Severity Index (PASI) >=12 and body surface area (BSA) affected by PSO >=10% and Investigator's Global Assessment (IGA) score >=3 on a 5-point scale\n * Subject is a candidate for systemic PSO therapy and/or phototherapy\n * Female subject of child bearing potential must be willing to use highly effective method of contraception\n\n","\n\n * Subject has an active infection (except common cold), a recent serious infection, or a history of opportunistic, recurrent, or chronic infections\n * Subject has concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection\n * Subject has known tuberculosis (TB) infection, is at high risk of acquiring TB infection, or has current or history of nontuberculous mycobacterium (NTMB) infection\n * Subject has any other condition, including medical or psychiatric, which, in the Investigator's judgment, would make the subject unsuitable for inclusion in the study\n * Presence of active suicidal ideation or positive suicide behavior\n * Presence of moderately severe major depression or severe major depression\n * Subject has any active malignancy or history of malignancy within 5 years prior to the Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma, or in situ cervical cancer",{"$nulls":4},"Actual","2018-01-25","Actual","Anticipated","2020-02-01","Anticipated","2018-07-01","2018-01-19","2018-01-19","2018-07-19","Yes","Bimekizumab\nPSO\nPsoriasis","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"All",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2016-003426-16","EudraCT Number","Psoriasis Area and Severity Index 90 (PASI90) response at Week 16|Investigator's Global Assessment (IGA) response at Week 16","A PASI90 responder is defined as a subject that achieves 90% reduction from Baseline in the PASI score.|IGA response is defined as Clear or Almost Clear with at least a 2-category improvement relative to Baseline.","Week 16","PASI100 response at Week 16|PASI75 response at Week 4|Change from Baseline in the Patient Symptom Diary responses for itch at Week 16|Change from Baseline in the Patient Symptom Diary responses for pain at Week 16|Change from Baseline in the Patient Symptom Diary responses for scaling at Week 16|IGA response (Clear or Almost Clear) at Week 16 for subjects with scalp psoriasis (PSO) at Baseline|PASI90 response at Week 56 among Week 16 PASI90 responders|Number of Treatment Emergent Adverse Events (TEAEs) adjusted by duration of subject exposure to study treatment|Number of Serious Adverse Events (SAEs) adjusted by duration of subject exposure to study treatment|Number of TEAEs leading to withdrawal adjusted by duration of subject exposure to study treatment","A PASI100 responder is defined as a subject that achieves 100% reduction from Baseline in the PASI score.|A PASI75 responder is defined as a subject that achieves 75% reduction from Baseline in the PASI score.|A Patient-Reported outcome (PRO) measure will be used to assess key symptoms relevant to patients with moderate to severe chronic plaque PSO. Site staff will train the participating subjects on the use of the electronic PRO (ePRO) diary at the Screening Visit, following which the device will be dispensed to the subject for home use until the Week 16 Visit. The ePRO diary will be administered on a daily basis from Screening to the Week 16 Visit.|A PRO measure will be used to assess key symptoms relevant to patients with moderate to severe chronic plaque PSO. Site staff will train the participating subjects on the use of the electronic PRO (ePRO) diary at the Screening Visit, following which the device will be dispensed to the subject for home use until the Week 16 Visit. The ePRO diary will be administered on a daily basis from Screening to the Week 16 Visit.|Only subjects with scalp involvement at Baseline will complete the scalp IGA. Subjects with scalp involvement at Baseline are defined as those with a scalp IGA score >0 at Baseline. Scalp lesions will be assessed in terms of clinical signs of redness, thickness, and scaliness using a 5-point scale (0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, 4= Severe).|A PASI90 responder is defined as a subject that achieves 90% reduction from Baseline in the PASI score.|The number of TEAEs adjusted by duration of exposure to study treatment is scaled such that it provides an incidence rate per 100 patient-years. If a subject has multiple events, the time of exposure is calculated to the first occurrence of the Adverse Event (AE) being considered. If a subject has no events, the total time at risk is used.|The number of SAEs adjusted by duration of exposure to study treatment is scaled such that it provides an incidence rate per 100 patient-years. If a subject has multiple events, the time of exposure is calculated to the first occurrence of the AE being considered. If a subject has no events, the total time at risk is used.|The number of TEAEs leading to discontinuation adjusted by duration of exposure to study treatment is scaled such that it provides an incidence rate per 100 patient-years. If a subject has multiple events, the time of exposure is calculated to the first occurrence of the AE being considered. If a subject has no events, the total time at risk is used.","Week 16|Week 4|Week 56|From Baseline to Safety Follow Up (up to Week 76)","UCBCares@ucb.com","UCB Cares","+1844599 Ext. 2273","Ajax, Canada Ps0013 672Edmonton, Canada Ps0013 671Hamilton, Canada Ps0013 675Markham, Canada Ps0013 663Mississauga, Canada Ps0013 660MontrÃ©al, Canada Ps0013 668North Bay, Canada Ps0013 667Ottawa, Canada Ps0013 665QuÃ©bec, Canada Ps0013 676Surrey, Canada Ps0013 657Waterloo, Canada|Hamburg, Germany Ps0013 200Schwerin, Germany Ps0013 204Witten, Germany|Budapest, Hungary Ps0013 262Miskolc, Hungary Ps0013 253OroshÃ¡za, Hungary Ps0013 260Szeged, Hungary Ps0013 250Szolnok, Hungary Ps0013 257Szombathely, Hungary Ps0013 258VeszprÃ©m, Hungary|BiaÅ‚ystok, Poland Ps0013 361BiaÅ‚ystok, Poland Ps0013 369BiaÅ‚ystok, Poland Ps0013 358Katowice, Poland Ps0013 363KrakÃ³w, Poland Ps0013 374PoznaÅ„, Poland Ps0013 353Szczecin, Poland Ps0013 350Warsaw, Poland Ps0013 365WrocÅ‚aw, Poland Ps0013 368WrocÅ‚aw, Poland Ps0013 370WrocÅ‚aw, Poland Ps0013 360Å\u0081Ã³dÅº, Poland Russian Federation Ps0013 402Moscow, Russian Federation|San Diego, California, United States, 92103 Ps0013 955San Diego, California, United States, 92123 Ps0013 967Santa Monica, California, United States, 90404|Fort Myers, Florida, United States, 33912|Sandy Springs, Georgia, United States, 30329|Skokie, Illinois, United States, 60077|Owensboro, Kentucky, United States, 42303|New Orleans, Louisiana, United States, 70115|Beverly, Massachusetts, United States, 01915 Ps0013 925Brighton, Massachusetts, United States, 02135|Portsmouth, New Hampshire, United States, 03801|Verona, New Jersey, United States, 07044-2946|Buffalo, New York, United States, 14221 Ps0013 968New York, New York, United States, 10021 Ps0013 965New York, New York, United States, 10025 Ps0013 963Rochester, New York, United States, 14623|Portland, Oregon, United States, 97223|Johnston, Rhode Island, United States, 02919|San Antonio, Texas, United States, 78213","California|Florida|Georgia|Illinois|Kentucky|Louisiana|Massachusetts|New Hampshire|New Jersey|New York|Oregon|Rhode Island|Texas","Canada|Germany|Hungary|Poland|United States","Ps0013 658|Ps0013 220|Ps0013 261|Ps0013 355|Ps0013 919|Ps0013 928|Ps0013 966|Ps0013 954|Ps0013 962|Ps0013 944|Ps0013 940|Ps0013 901|Ps0013 956|Ps0013 947|Ps0013 929|Ps0013 937|Ps0013 914",{"$nulls":3},"UCB Cares","2018-07-19","2020-05-25T16:38:44.786","2020-05-26T17:10:42.972","NCT03410992"]
["5ecbf494e2561b1b11905e4a","NCT03410992","2018-08-20","UCB","UCBJF","Recruiting","A Study With a Initial Treatment Period Followed by a Randomized-withdrawal Period to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis (BE READY)","Bimekizumab","IL17A Inhibitor","Yes","['Bimekizumab']","No",null,"Phase 3",2,400,"Anticipated","2018-02-05","2019-02-01","PASI","Psoriasis Area and Severity Index",{"$nulls":3},"Phase 3 study to compare the efficacy of bimekizumab versus placebo in the treatment of subjects with moderate to severe chronic plaque psoriasis.",null,"A Phase 3, Multicenter, Double-Blind, Placebo-Controlled Study With an Initial Treatment Period Followed by a Randomized-Withdrawal Period to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis","PS0013","Chronic Plaque Psoriasis\nModerate to Severe Chronic Plaque Psoriasis\nPsoriatic Arthritis","Arthritis|Psoriasis|Arthritis, Psoriatic","Joint Diseases|Dermatological Diseases|Bone Diseases","Musculoskeletal|Derm & Connective Tissue Disorders","Experimental|Placebo Comparator","Bimekizumab cohort|Placebo","Subjects will receive bimekizumab for 16 Weeks. Subjects who achieve certain predefined response criteria will be re-randomized to either receive bimekizumab or placebo until Week 56. Subjects who do not achieve predefined response criteria will enter the bimekizumab escape arm.|Subjects will receive placebo for 16 Weeks. Subjects who achieve certain predefined response criteria will proceed with placebo until Week 56. Subjects who do not achieve certain predefined response criteria will enter the bimekizumab escape arm.","Drug","Bimekizumab|Placebo","Bimekizumab will be provided at pre-specified time intervals.|Subjects will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products.","UCB4940\nPlaceboSubjects will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products.|PBO","Bimekizumab cohort|Placebo","\n\n * Must be at least 18 years of age\n * Chronic plaque psoriasis (PSO) for at least 6 months prior to the Screening Visit\n * Psoriasis Area Severity Index (PASI) >=12 and body surface area (BSA) affected by PSO >=10% and Investigator's Global Assessment (IGA) score >=3 on a 5-point scale\n * Subject is a candidate for systemic PSO therapy and/or phototherapy\n * Female subject of child bearing potential must be willing to use highly effective method of contraception\n\n","\n\n * Subject has an active infection (except common cold), a recent serious infection, or a history of opportunistic, recurrent, or chronic infections\n * Subject has concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection\n * Subject has known tuberculosis (TB) infection, is at high risk of acquiring TB infection, or has current or history of nontuberculous mycobacterium (NTMB) infection\n * Subject has any other condition, including medical or psychiatric, which, in the Investigator's judgment, would make the subject unsuitable for inclusion in the study\n * Presence of active suicidal ideation or positive suicide behavior\n * Presence of moderately severe major depression or severe major depression\n * Subject has any active malignancy or history of malignancy within 5 years prior to the Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma, or in situ cervical cancer",{"$nulls":4},"Actual","2018-01-25","Actual","Anticipated","2020-02-01","Anticipated","2018-08-01","2018-01-19","2018-01-19","2018-08-17","Yes","Bimekizumab\nPSO\nPsoriasis","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"All",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2016-003426-16","EudraCT Number","Psoriasis Area and Severity Index 90 (PASI90) response at Week 16|Investigator's Global Assessment (IGA) response at Week 16","A PASI90 responder is defined as a subject that achieves 90% reduction from Baseline in the PASI score.|IGA response is defined as Clear or Almost Clear with at least a 2-category improvement relative to Baseline.","Week 16","PASI100 response at Week 16|PASI75 response at Week 4|Change from Baseline in the Patient Symptom Diary responses for itch at Week 16|Change from Baseline in the Patient Symptom Diary responses for pain at Week 16|Change from Baseline in the Patient Symptom Diary responses for scaling at Week 16|IGA response (Clear or Almost Clear) at Week 16 for subjects with scalp psoriasis (PSO) at Baseline|PASI90 response at Week 56 among Week 16 PASI90 responders|Number of Treatment Emergent Adverse Events (TEAEs) adjusted by duration of subject exposure to study treatment|Number of Serious Adverse Events (SAEs) adjusted by duration of subject exposure to study treatment|Number of TEAEs leading to withdrawal adjusted by duration of subject exposure to study treatment","A PASI100 responder is defined as a subject that achieves 100% reduction from Baseline in the PASI score.|A PASI75 responder is defined as a subject that achieves 75% reduction from Baseline in the PASI score.|A Patient-Reported outcome (PRO) measure will be used to assess key symptoms relevant to patients with moderate to severe chronic plaque PSO. Site staff will train the participating subjects on the use of the electronic PRO (ePRO) diary at the Screening Visit, following which the device will be dispensed to the subject for home use until the Week 16 Visit. The ePRO diary will be administered on a daily basis from Screening to the Week 16 Visit.|A PRO measure will be used to assess key symptoms relevant to patients with moderate to severe chronic plaque PSO. Site staff will train the participating subjects on the use of the electronic PRO (ePRO) diary at the Screening Visit, following which the device will be dispensed to the subject for home use until the Week 16 Visit. The ePRO diary will be administered on a daily basis from Screening to the Week 16 Visit.|Only subjects with scalp involvement at Baseline will complete the scalp IGA. Subjects with scalp involvement at Baseline are defined as those with a scalp IGA score >0 at Baseline. Scalp lesions will be assessed in terms of clinical signs of redness, thickness, and scaliness using a 5-point scale (0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, 4= Severe).|A PASI90 responder is defined as a subject that achieves 90% reduction from Baseline in the PASI score.|The number of TEAEs adjusted by duration of exposure to study treatment is scaled such that it provides an incidence rate per 100 patient-years. If a subject has multiple events, the time of exposure is calculated to the first occurrence of the Adverse Event (AE) being considered. If a subject has no events, the total time at risk is used.|The number of SAEs adjusted by duration of exposure to study treatment is scaled such that it provides an incidence rate per 100 patient-years. If a subject has multiple events, the time of exposure is calculated to the first occurrence of the AE being considered. If a subject has no events, the total time at risk is used.|The number of TEAEs leading to discontinuation adjusted by duration of exposure to study treatment is scaled such that it provides an incidence rate per 100 patient-years. If a subject has multiple events, the time of exposure is calculated to the first occurrence of the AE being considered. If a subject has no events, the total time at risk is used.","Week 16|Week 4|Week 56|From Baseline to Safety Follow Up (up to Week 76)","UCBCares@ucb.com","UCB Cares","+1844599 Ext. 2273","Ajax, Canada Ps0013 672Edmonton, Canada Ps0013 671Hamilton, Canada Ps0013 675Markham, Canada Ps0013 663Mississauga, Canada Ps0013 660MontrÃ©al, Canada Ps0013 668North Bay, Canada Ps0013 667Ottawa, Canada Ps0013 665QuÃ©bec, Canada Ps0013 676Surrey, Canada Ps0013 657Waterloo, Canada|Frankfurt/Main, Germany Ps0013 202Hamburg, Germany Ps0013 220Hamburg, Germany Ps0013 212Heidelberg, Germany Ps0013 201Kiel, Germany Ps0013 219MÃ¼nster, Germany Ps0013 200Schwerin, Germany Ps0013 204Witten, Germany|Budapest, Hungary Ps0013 262Miskolc, Hungary Ps0013 253OroshÃ¡za, Hungary Ps0013 260Szeged, Hungary Ps0013 250Szolnok, Hungary Ps0013 257Szombathely, Hungary Ps0013 258VeszprÃ©m, Hungary Korea, Republic Of Ps0013 701Busan, Korea, Republic Of Ps0013 705Seongnam-Si, Korea, Republic Of Ps0013 703Seoul, Korea, Republic Of|BiaÅ‚ystok, Poland Ps0013 361BiaÅ‚ystok, Poland Ps0013 362BiaÅ‚ystok, Poland Ps0013 369BiaÅ‚ystok, Poland Ps0013 352GdaÅ„sk, Poland Ps0013 358Katowice, Poland Ps0013 359Katowice, Poland Ps0013 366Katowice, Poland Ps0013 357Kielce, Poland Ps0013 363KrakÃ³w, Poland Ps0013 356Lublin, Poland Ps0013 374PoznaÅ„, Poland Ps0013 353Szczecin, Poland Ps0013 350Warsaw, Poland Ps0013 351Warsaw, Poland Ps0013 354Warszawa, Poland Ps0013 365WrocÅ‚aw, Poland Ps0013 368WrocÅ‚aw, Poland Ps0013 370WrocÅ‚aw, Poland Ps0013 360Å\u0081Ã³dÅº, Poland Russian Federation Ps0013 400Moscow, Russian Federation Ps0013 402Moscow, Russian Federation Ps0013 403Moscow, Russian Federation Ps0013 404Saint Petersburg, Russian Federation Ps0013 405Saint Petersburg, Russian Federation Ps0013 401Saratov, Russian Federation Ps0013 406Yaroslavl, Russian Federation|Edgbaston, United Kingdom Ps0013 555Salford, United Kingdom|San Diego, California, United States, 92103 Ps0013 955San Diego, California, United States, 92123 Ps0013 967Santa Monica, California, United States, 90404|Fort Myers, Florida, United States, 33912|Sandy Springs, Georgia, United States, 30329|Skokie, Illinois, United States, 60077|Owensboro, Kentucky, United States, 42303|New Orleans, Louisiana, United States, 70115|Beverly, Massachusetts, United States, 01915 Ps0013 925Brighton, Massachusetts, United States, 02135|Portsmouth, New Hampshire, United States, 03801|Verona, New Jersey, United States, 07044-2946|Buffalo, New York, United States, 14221 Ps0013 968New York, New York, United States, 10021 Ps0013 965New York, New York, United States, 10025 Ps0013 963Rochester, New York, United States, 14623|Cleveland, Ohio, United States, 44106-1716|Portland, Oregon, United States, 97223|Johnston, Rhode Island, United States, 02919|San Antonio, Texas, United States, 78213|Murray, Utah, United States, 84107","California|Florida|Georgia|Illinois|Kentucky|Louisiana|Massachusetts|New Hampshire|New Jersey|New York|Ohio|Oregon|Rhode Island|Texas|Utah","Canada|Germany|Hungary|Poland|United Kingdom|United States","Ps0013 658|Ps0013 208|Ps0013 261|Ps0013 355|Ps0013 553|Ps0013 919|Ps0013 928|Ps0013 966|Ps0013 954|Ps0013 962|Ps0013 944|Ps0013 940|Ps0013 901|Ps0013 956|Ps0013 947|Ps0013 949|Ps0013 929|Ps0013 937|Ps0013 914|Ps0013 933",{"$nulls":3},"UCB Cares","2018-08-17","2020-05-25T16:38:44.940","2020-05-26T17:10:42.972","NCT03410992"]
["5ecbf495307e3d1b1f8d9de2","NCT03410992","2018-11-09","UCB","UCBJF","Active, not recruiting","A Study With a Initial Treatment Period Followed by a Randomized-withdrawal Period to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis (BE READY)","Bimekizumab","IL17A Inhibitor","Yes","['Bimekizumab']","No",null,"Phase 3",2,435,"Actual","2018-02-05","2019-02-01","PASI","Psoriasis Area and Severity Index",{"$nulls":3},"Phase 3 study to compare the efficacy of bimekizumab versus placebo in the treatment of subjects with moderate to severe chronic plaque psoriasis.",null,"A Phase 3, Multicenter, Double-Blind, Placebo-Controlled Study With an Initial Treatment Period Followed by a Randomized-Withdrawal Period to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis","PS0013","Chronic Plaque Psoriasis\nModerate to Severe Chronic Plaque Psoriasis\nPsoriatic Arthritis","Arthritis|Psoriasis|Arthritis, Psoriatic","Joint Diseases|Dermatological Diseases|Bone Diseases","Musculoskeletal|Derm & Connective Tissue Disorders","Experimental|Placebo Comparator","Bimekizumab cohort|Placebo","Subjects will receive bimekizumab for 16 Weeks. Subjects who achieve certain predefined response criteria will be re-randomized to either receive bimekizumab or placebo until Week 56. Subjects who do not achieve predefined response criteria will enter the bimekizumab escape arm.|Subjects will receive placebo for 16 Weeks. Subjects who achieve certain predefined response criteria will proceed with placebo until Week 56. Subjects who do not achieve certain predefined response criteria will enter the bimekizumab escape arm.","Drug","Bimekizumab|Placebo","Bimekizumab will be provided at pre-specified time intervals.|Subjects will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products.","UCB4940\nPlaceboSubjects will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products.|PBO","Bimekizumab cohort|Placebo","\n\n * Must be at least 18 years of age\n * Chronic plaque psoriasis (PSO) for at least 6 months prior to the Screening Visit\n * Psoriasis Area Severity Index (PASI) >=12 and body surface area (BSA) affected by PSO >=10% and Investigator's Global Assessment (IGA) score >=3 on a 5-point scale\n * Subject is a candidate for systemic PSO therapy and/or phototherapy\n * Female subject of child bearing potential must be willing to use highly effective method of contraception\n\n","\n\n * Subject has an active infection (except common cold), a recent serious infection, or a history of opportunistic, recurrent, or chronic infections\n * Subject has concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection\n * Subject has known tuberculosis (TB) infection, is at high risk of acquiring TB infection, or has current or history of nontuberculous mycobacterium (NTMB) infection\n * Subject has any other condition, including medical or psychiatric, which, in the Investigator's judgment, would make the subject unsuitable for inclusion in the study\n * Presence of active suicidal ideation or positive suicide behavior\n * Presence of moderately severe major depression or severe major depression\n * Subject has any active malignancy or history of malignancy within 5 years prior to the Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma, or in situ cervical cancer",{"$nulls":4},"Actual","2018-01-25","Actual","Anticipated","2020-02-01","Anticipated","2018-11-01","2018-01-19","2018-01-19","2018-11-08","Yes","Bimekizumab\nPSO\nPsoriasis","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"All",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2016-003426-16","EudraCT Number","Psoriasis Area and Severity Index 90 (PASI90) response at Week 16|Investigator's Global Assessment (IGA) response at Week 16","A PASI90 responder is defined as a subject that achieves 90% reduction from Baseline in the PASI score.|IGA response is defined as Clear or Almost Clear with at least a 2-category improvement relative to Baseline.","Week 16","PASI100 response at Week 16|PASI75 response at Week 4|Change from Baseline in the Patient Symptom Diary responses for itch at Week 16|Change from Baseline in the Patient Symptom Diary responses for pain at Week 16|Change from Baseline in the Patient Symptom Diary responses for scaling at Week 16|IGA response (Clear or Almost Clear) at Week 16 for subjects with scalp psoriasis (PSO) at Baseline|PASI90 response at Week 56 among Week 16 PASI90 responders|Number of Treatment Emergent Adverse Events (TEAEs) adjusted by duration of subject exposure to study treatment|Number of Serious Adverse Events (SAEs) adjusted by duration of subject exposure to study treatment|Number of TEAEs leading to withdrawal adjusted by duration of subject exposure to study treatment","A PASI100 responder is defined as a subject that achieves 100% reduction from Baseline in the PASI score.|A PASI75 responder is defined as a subject that achieves 75% reduction from Baseline in the PASI score.|A Patient-Reported outcome (PRO) measure will be used to assess key symptoms relevant to patients with moderate to severe chronic plaque PSO. Site staff will train the participating subjects on the use of the electronic PRO (ePRO) diary at the Screening Visit, following which the device will be dispensed to the subject for home use until the Week 16 Visit. The ePRO diary will be administered on a daily basis from Screening to the Week 16 Visit.|A PRO measure will be used to assess key symptoms relevant to patients with moderate to severe chronic plaque PSO. Site staff will train the participating subjects on the use of the electronic PRO (ePRO) diary at the Screening Visit, following which the device will be dispensed to the subject for home use until the Week 16 Visit. The ePRO diary will be administered on a daily basis from Screening to the Week 16 Visit.|Only subjects with scalp involvement at Baseline will complete the scalp IGA. Subjects with scalp involvement at Baseline are defined as those with a scalp IGA score >0 at Baseline. Scalp lesions will be assessed in terms of clinical signs of redness, thickness, and scaliness using a 5-point scale (0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, 4= Severe).|A PASI90 responder is defined as a subject that achieves 90% reduction from Baseline in the PASI score.|The number of TEAEs adjusted by duration of exposure to study treatment is scaled such that it provides an incidence rate per 100 patient-years. If a subject has multiple events, the time of exposure is calculated to the first occurrence of the Adverse Event (AE) being considered. If a subject has no events, the total time at risk is used.|The number of SAEs adjusted by duration of exposure to study treatment is scaled such that it provides an incidence rate per 100 patient-years. If a subject has multiple events, the time of exposure is calculated to the first occurrence of the AE being considered. If a subject has no events, the total time at risk is used.|The number of TEAEs leading to discontinuation adjusted by duration of exposure to study treatment is scaled such that it provides an incidence rate per 100 patient-years. If a subject has multiple events, the time of exposure is calculated to the first occurrence of the AE being considered. If a subject has no events, the total time at risk is used.","Week 16|Week 4|Week 56|From Baseline to Safety Follow Up (up to Week 76)",{"$nulls":3},"Carlton, Australia Ps0013 008East Melbourne, Australia|Ajax, Canada Ps0013 672Edmonton, Canada Ps0013 671Hamilton, Canada Ps0013 675Markham, Canada Ps0013 663Mississauga, Canada Ps0013 660MontrÃ©al, Canada Ps0013 668North Bay, Canada Ps0013 667Ottawa, Canada Ps0013 665QuÃ©bec, Canada Ps0013 676Surrey, Canada Ps0013 657Waterloo, Canada|Frankfurt/Main, Germany Ps0013 202Hamburg, Germany Ps0013 220Hamburg, Germany Ps0013 212Heidelberg, Germany Ps0013 201Kiel, Germany Ps0013 219MÃ¼nster, Germany Ps0013 200Schwerin, Germany Ps0013 204Witten, Germany|Budapest, Hungary Ps0013 262Miskolc, Hungary Ps0013 253OroshÃ¡za, Hungary Ps0013 260Szeged, Hungary Ps0013 250Szolnok, Hungary Ps0013 257Szombathely, Hungary Ps0013 258VeszprÃ©m, Hungary Korea, Republic Of Ps0013 701Busan, Korea, Republic Of Ps0013 705Seongnam-Si, Korea, Republic Of Ps0013 703Seoul, Korea, Republic Of|BiaÅ‚ystok, Poland Ps0013 361BiaÅ‚ystok, Poland Ps0013 362BiaÅ‚ystok, Poland Ps0013 369BiaÅ‚ystok, Poland Ps0013 352GdaÅ„sk, Poland Ps0013 358Katowice, Poland Ps0013 359Katowice, Poland Ps0013 366Katowice, Poland Ps0013 357Kielce, Poland Ps0013 363KrakÃ³w, Poland Ps0013 356Lublin, Poland Ps0013 374PoznaÅ„, Poland Ps0013 353Szczecin, Poland Ps0013 350Warsaw, Poland Ps0013 351Warsaw, Poland Ps0013 354Warszawa, Poland Ps0013 365WrocÅ‚aw, Poland Ps0013 368WrocÅ‚aw, Poland Ps0013 370WrocÅ‚aw, Poland Ps0013 360Å\u0081Ã³dÅº, Poland Russian Federation Ps0013 400Moscow, Russian Federation Ps0013 402Moscow, Russian Federation Ps0013 403Moscow, Russian Federation Ps0013 404Saint Petersburg, Russian Federation Ps0013 405Saint Petersburg, Russian Federation Ps0013 401Saratov, Russian Federation Ps0013 406Yaroslavl, Russian Federation|Edgbaston, United Kingdom Ps0013 550Manchester, United Kingdom Ps0013 554Reading, United Kingdom Ps0013 555Salford, United Kingdom|San Diego, California, United States, 92103 Ps0013 955San Diego, California, United States, 92123 Ps0013 967Santa Monica, California, United States, 90404|Fort Myers, Florida, United States, 33912|Sandy Springs, Georgia, United States, 30329|Skokie, Illinois, United States, 60077|Owensboro, Kentucky, United States, 42303|New Orleans, Louisiana, United States, 70115|Beverly, Massachusetts, United States, 01915 Ps0013 925Brighton, Massachusetts, United States, 02135|Portsmouth, New Hampshire, United States, 03801|Verona, New Jersey, United States, 07044-2946|Buffalo, New York, United States, 14221 Ps0013 968New York, New York, United States, 10021 Ps0013 965New York, New York, United States, 10025 Ps0013 963Rochester, New York, United States, 14623|Cleveland, Ohio, United States, 44106-1716|Portland, Oregon, United States, 97223|Johnston, Rhode Island, United States, 02919|San Antonio, Texas, United States, 78213|Murray, Utah, United States, 84107","California|Florida|Georgia|Illinois|Kentucky|Louisiana|Massachusetts|New Hampshire|New Jersey|New York|Ohio|Oregon|Rhode Island|Texas|Utah","Australia|Canada|Germany|Hungary|Poland|United Kingdom|United States","Ps0013 003|Ps0013 658|Ps0013 208|Ps0013 261|Ps0013 355|Ps0013 553|Ps0013 919|Ps0013 928|Ps0013 966|Ps0013 954|Ps0013 962|Ps0013 944|Ps0013 940|Ps0013 901|Ps0013 956|Ps0013 947|Ps0013 949|Ps0013 929|Ps0013 937|Ps0013 914|Ps0013 933",{"$nulls":3},"UCB Cares","2018-11-08","2020-05-25T16:38:45.260","2020-05-26T17:10:42.972","NCT03410992"]
["5ecbf495fe30261b1a048352","NCT03410992","2019-01-04","UCB","UCBJF","Active, not recruiting","A Study With a Initial Treatment Period Followed by a Randomized-withdrawal Period to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis (BE READY)","Bimekizumab","IL17A Inhibitor","Yes","['Bimekizumab']","No",null,"Phase 3",2,435,"Actual","2018-02-05","2019-02-01","PASI","Psoriasis Area and Severity Index",{"$nulls":3},"Phase 3 study to compare the efficacy of bimekizumab versus placebo in the treatment of subjects with moderate to severe chronic plaque psoriasis.",null,"A Phase 3, Multicenter, Double-Blind, Placebo-Controlled Study With an Initial Treatment Period Followed by a Randomized-Withdrawal Period to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis","PS0013","Chronic Plaque Psoriasis\nModerate to Severe Chronic Plaque Psoriasis\nPsoriatic Arthritis","Arthritis|Psoriasis|Arthritis, Psoriatic","Joint Diseases|Dermatological Diseases|Bone Diseases","Musculoskeletal|Derm & Connective Tissue Disorders","Experimental|Placebo Comparator","Bimekizumab cohort|Placebo","Subjects will receive bimekizumab for 16 Weeks. Subjects who achieve certain predefined response criteria will be re-randomized to either receive bimekizumab or placebo until Week 56. Subjects who do not achieve predefined response criteria will enter the bimekizumab escape arm.|Subjects will receive placebo for 16 Weeks. Subjects who achieve certain predefined response criteria will proceed with placebo until Week 56. Subjects who do not achieve certain predefined response criteria will enter the bimekizumab escape arm.","Drug","Bimekizumab|Placebo","Bimekizumab will be provided at pre-specified time intervals.|Subjects will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products.","UCB4940\nPlaceboSubjects will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products.|PBO","Bimekizumab cohort|Placebo","\n\n * Must be at least 18 years of age\n * Chronic plaque psoriasis (PSO) for at least 6 months prior to the Screening Visit\n * Psoriasis Area Severity Index (PASI) >=12 and body surface area (BSA) affected by PSO >=10% and Investigator's Global Assessment (IGA) score >=3 on a 5-point scale\n * Subject is a candidate for systemic PSO therapy and/or phototherapy\n * Female subject of child bearing potential must be willing to use highly effective method of contraception\n\n","\n\n * Subject has an active infection (except common cold), a recent serious infection, or a history of opportunistic, recurrent, or chronic infections\n * Subject has concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection\n * Subject has known tuberculosis (TB) infection, is at high risk of acquiring TB infection, or has current or history of nontuberculous mycobacterium (NTMB) infection\n * Subject has any other condition, including medical or psychiatric, which, in the Investigator's judgment, would make the subject unsuitable for inclusion in the study\n * Presence of active suicidal ideation or positive suicide behavior\n * Presence of moderately severe major depression or severe major depression\n * Subject has any active malignancy or history of malignancy within 5 years prior to the Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma, or in situ cervical cancer",{"$nulls":4},"Actual","2018-01-25","Actual","Anticipated","2020-02-01","Anticipated","2019-01-01","2018-01-19","2018-01-19","2019-01-03","Yes","Bimekizumab\nPSO\nPsoriasis","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"All",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2016-003426-16","EudraCT Number","Psoriasis Area and Severity Index 90 (PASI90) response at Week 16|Investigator's Global Assessment (IGA) response at Week 16","A PASI90 responder is defined as a subject that achieves 90% reduction from Baseline in the PASI score.|IGA response is defined as Clear or Almost Clear with at least a 2-category improvement relative to Baseline.","Week 16","PASI100 response at Week 16|PASI75 response at Week 4|Change from Baseline in the Patient Symptom Diary responses for itch at Week 16|Change from Baseline in the Patient Symptom Diary responses for pain at Week 16|Change from Baseline in the Patient Symptom Diary responses for scaling at Week 16|IGA response (Clear or Almost Clear) at Week 16 for subjects with scalp psoriasis (PSO) at Baseline|PASI90 response at Week 56 among Week 16 PASI90 responders|Number of Treatment Emergent Adverse Events (TEAEs) adjusted by duration of subject exposure to study treatment|Number of Serious Adverse Events (SAEs) adjusted by duration of subject exposure to study treatment|Number of TEAEs leading to withdrawal adjusted by duration of subject exposure to study treatment","A PASI100 responder is defined as a subject that achieves 100% reduction from Baseline in the PASI score.|A PASI75 responder is defined as a subject that achieves 75% reduction from Baseline in the PASI score.|A Patient-Reported outcome (PRO) measure will be used to assess key symptoms relevant to patients with moderate to severe chronic plaque PSO. Site staff will train the participating subjects on the use of the electronic PRO (ePRO) diary at the Screening Visit, following which the device will be dispensed to the subject for home use until the Week 16 Visit. The ePRO diary will be administered on a daily basis from Screening to the Week 16 Visit.|A PRO measure will be used to assess key symptoms relevant to patients with moderate to severe chronic plaque PSO. Site staff will train the participating subjects on the use of the electronic PRO (ePRO) diary at the Screening Visit, following which the device will be dispensed to the subject for home use until the Week 16 Visit. The ePRO diary will be administered on a daily basis from Screening to the Week 16 Visit.|Only subjects with scalp involvement at Baseline will complete the scalp IGA. Subjects with scalp involvement at Baseline are defined as those with a scalp IGA score >0 at Baseline. Scalp lesions will be assessed in terms of clinical signs of redness, thickness, and scaliness using a 5-point scale (0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, 4= Severe).|A PASI90 responder is defined as a subject that achieves 90% reduction from Baseline in the PASI score.|The number of TEAEs adjusted by duration of exposure to study treatment is scaled such that it provides an incidence rate per 100 patient-years. If a subject has multiple events, the time of exposure is calculated to the first occurrence of the Adverse Event (AE) being considered. If a subject has no events, the total time at risk is used.|The number of SAEs adjusted by duration of exposure to study treatment is scaled such that it provides an incidence rate per 100 patient-years. If a subject has multiple events, the time of exposure is calculated to the first occurrence of the AE being considered. If a subject has no events, the total time at risk is used.|The number of TEAEs leading to discontinuation adjusted by duration of exposure to study treatment is scaled such that it provides an incidence rate per 100 patient-years. If a subject has multiple events, the time of exposure is calculated to the first occurrence of the AE being considered. If a subject has no events, the total time at risk is used.","Week 16|Week 4|Week 56|From Baseline to Safety Follow Up (up to Week 76)",{"$nulls":3},"Carlton, Australia Ps0013 008East Melbourne, Australia|Ajax, Canada Ps0013 672Edmonton, Canada Ps0013 671Hamilton, Canada Ps0013 675Markham, Canada Ps0013 663Mississauga, Canada Ps0013 660MontrÃ©al, Canada Ps0013 668North Bay, Canada Ps0013 667Ottawa, Canada Ps0013 665QuÃ©bec, Canada Ps0013 676Surrey, Canada Ps0013 657Waterloo, Canada|Hamburg, Germany Ps0013 220Hamburg, Germany Ps0013 201Kiel, Germany Ps0013 219MÃ¼nster, Germany Ps0013 200Schwerin, Germany Ps0013 204Witten, Germany|Budapest, Hungary Ps0013 262Miskolc, Hungary Ps0013 253OroshÃ¡za, Hungary Ps0013 260Szeged, Hungary Ps0013 250Szolnok, Hungary Ps0013 258VeszprÃ©m, Hungary Korea, Republic Of Ps0013 701Busan, Korea, Republic Of Ps0013 705Seongnam-Si, Korea, Republic Of Ps0013 703Seoul, Korea, Republic Of|BiaÅ‚ystok, Poland Ps0013 361BiaÅ‚ystok, Poland Ps0013 369BiaÅ‚ystok, Poland Ps0013 352GdaÅ„sk, Poland Ps0013 358Katowice, Poland Ps0013 359Katowice, Poland Ps0013 366Katowice, Poland Ps0013 357Kielce, Poland Ps0013 363KrakÃ³w, Poland Ps0013 356Lublin, Poland Ps0013 374PoznaÅ„, Poland Ps0013 353Szczecin, Poland Ps0013 350Warsaw, Poland Ps0013 351Warsaw, Poland Ps0013 354Warszawa, Poland Ps0013 365WrocÅ‚aw, Poland Ps0013 368WrocÅ‚aw, Poland Ps0013 370WrocÅ‚aw, Poland Ps0013 360Å\u0081Ã³dÅº, Poland Russian Federation Ps0013 400Moscow, Russian Federation Ps0013 402Moscow, Russian Federation Ps0013 403Moscow, Russian Federation Ps0013 404Saint Petersburg, Russian Federation Ps0013 405Saint Petersburg, Russian Federation Ps0013 401Saratov, Russian Federation Ps0013 406Yaroslavl, Russian Federation|Manchester, United Kingdom Ps0013 554Reading, United Kingdom Ps0013 555Salford, United Kingdom|San Diego, California, United States, 92103 Ps0013 955San Diego, California, United States, 92123 Ps0013 967Santa Monica, California, United States, 90404|Fort Myers, Florida, United States, 33912|Sandy Springs, Georgia, United States, 30329|Skokie, Illinois, United States, 60077|Owensboro, Kentucky, United States, 42303|New Orleans, Louisiana, United States, 70115|Beverly, Massachusetts, United States, 01915 Ps0013 925Brighton, Massachusetts, United States, 02135|Portsmouth, New Hampshire, United States, 03801|Verona, New Jersey, United States, 07044-2946|Buffalo, New York, United States, 14221 Ps0013 968New York, New York, United States, 10021 Ps0013 965New York, New York, United States, 10025 Ps0013 963Rochester, New York, United States, 14623|Cleveland, Ohio, United States, 44106-1716|Portland, Oregon, United States, 97223|Johnston, Rhode Island, United States, 02919|San Antonio, Texas, United States, 78213|Murray, Utah, United States, 84107","California|Florida|Georgia|Illinois|Kentucky|Louisiana|Massachusetts|New Hampshire|New Jersey|New York|Ohio|Oregon|Rhode Island|Texas|Utah","Australia|Canada|Germany|Hungary|Poland|United Kingdom|United States","Ps0013 003|Ps0013 658|Ps0013 202|Ps0013 261|Ps0013 355|Ps0013 550|Ps0013 919|Ps0013 928|Ps0013 966|Ps0013 954|Ps0013 962|Ps0013 944|Ps0013 940|Ps0013 901|Ps0013 956|Ps0013 947|Ps0013 949|Ps0013 929|Ps0013 937|Ps0013 914|Ps0013 933",{"$nulls":3},"UCB Cares","2019-01-03","2020-05-25T16:38:45.426","2020-05-26T17:10:42.972","NCT03410992"]
["5ecbf495e2561b1b11905e4c","NCT03410992","2019-03-04","UCB","UCBJF","Active, not recruiting","A Study With a Initial Treatment Period Followed by a Randomized-withdrawal Period to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis (BE READY)","Bimekizumab","IL17A Inhibitor","Yes","['Bimekizumab']","No",null,"Phase 3",2,435,"Actual","2018-02-05","2018-12-28","PASI","Psoriasis Area and Severity Index",{"$nulls":3},"Phase 3 study to compare the efficacy of bimekizumab versus placebo in the treatment of subjects with moderate to severe chronic plaque psoriasis.",null,"A Phase 3, Multicenter, Double-Blind, Placebo-Controlled Study With an Initial Treatment Period Followed by a Randomized-Withdrawal Period to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis","PS0013","Chronic Plaque Psoriasis\nModerate to Severe Chronic Plaque Psoriasis\nPsoriatic Arthritis","Arthritis|Psoriasis|Arthritis, Psoriatic","Joint Diseases|Dermatological Diseases|Bone Diseases","Musculoskeletal|Derm & Connective Tissue Disorders","Experimental|Placebo Comparator","Bimekizumab cohort|Placebo","Subjects will receive bimekizumab for 16 Weeks. Subjects who achieve certain predefined response criteria will be re-randomized to either receive bimekizumab or placebo until Week 56. Subjects who do not achieve predefined response criteria will enter the bimekizumab escape arm.|Subjects will receive placebo for 16 Weeks. Subjects who achieve certain predefined response criteria will proceed with placebo until Week 56. Subjects who do not achieve certain predefined response criteria will enter the bimekizumab escape arm.","Drug","Bimekizumab|Placebo","Bimekizumab will be provided at pre-specified time intervals.|Subjects will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products.","UCB4940\nPlaceboSubjects will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products.|PBO","Bimekizumab cohort|Placebo","\n\n * Must be at least 18 years of age\n * Chronic plaque psoriasis (PSO) for at least 6 months prior to the Screening Visit\n * Psoriasis Area Severity Index (PASI) >=12 and body surface area (BSA) affected by PSO >=10% and Investigator's Global Assessment (IGA) score >=3 on a 5-point scale\n * Subject is a candidate for systemic PSO therapy and/or phototherapy\n * Female subject of child bearing potential must be willing to use highly effective method of contraception\n\n","\n\n * Subject has an active infection (except common cold), a recent serious infection, or a history of opportunistic, recurrent, or chronic infections\n * Subject has concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection\n * Subject has known tuberculosis (TB) infection, is at high risk of acquiring TB infection, or has current or history of nontuberculous mycobacterium (NTMB) infection\n * Subject has any other condition, including medical or psychiatric, which, in the Investigator's judgment, would make the subject unsuitable for inclusion in the study\n * Presence of active suicidal ideation or positive suicide behavior\n * Presence of moderately severe major depression or severe major depression\n * Subject has any active malignancy or history of malignancy within 5 years prior to the Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma, or in situ cervical cancer",{"$nulls":4},"Actual","2018-01-25","Actual","Actual","2020-01-01","Anticipated","2019-03-01","2018-01-19","2018-01-19","2019-03-01","Yes","Bimekizumab\nPSO\nPsoriasis","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"All",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2016-003426-16","EudraCT Number","Psoriasis Area and Severity Index 90 (PASI90) response at Week 16|Investigator's Global Assessment (IGA) response at Week 16","A PASI90 responder is defined as a subject that achieves 90% reduction from Baseline in the PASI score.|IGA response is defined as Clear or Almost Clear with at least a 2-category improvement relative to Baseline.","Week 16","PASI100 response at Week 16|PASI75 response at Week 4|Change from Baseline in the Patient Symptom Diary responses for itch at Week 16|Change from Baseline in the Patient Symptom Diary responses for pain at Week 16|Change from Baseline in the Patient Symptom Diary responses for scaling at Week 16|IGA response (Clear or Almost Clear) at Week 16 for subjects with scalp psoriasis (PSO) at Baseline|PASI90 response at Week 56 among Week 16 PASI90 responders|Number of Treatment Emergent Adverse Events (TEAEs) adjusted by duration of subject exposure to study treatment|Number of Serious Adverse Events (SAEs) adjusted by duration of subject exposure to study treatment|Number of TEAEs leading to withdrawal adjusted by duration of subject exposure to study treatment","A PASI100 responder is defined as a subject that achieves 100% reduction from Baseline in the PASI score.|A PASI75 responder is defined as a subject that achieves 75% reduction from Baseline in the PASI score.|A Patient-Reported outcome (PRO) measure will be used to assess key symptoms relevant to patients with moderate to severe chronic plaque PSO. Site staff will train the participating subjects on the use of the electronic PRO (ePRO) diary at the Screening Visit, following which the device will be dispensed to the subject for home use until the Week 16 Visit. The ePRO diary will be administered on a daily basis from Screening to the Week 16 Visit.|A PRO measure will be used to assess key symptoms relevant to patients with moderate to severe chronic plaque PSO. Site staff will train the participating subjects on the use of the electronic PRO (ePRO) diary at the Screening Visit, following which the device will be dispensed to the subject for home use until the Week 16 Visit. The ePRO diary will be administered on a daily basis from Screening to the Week 16 Visit.|Only subjects with scalp involvement at Baseline will complete the scalp IGA. Subjects with scalp involvement at Baseline are defined as those with a scalp IGA score >0 at Baseline. Scalp lesions will be assessed in terms of clinical signs of redness, thickness, and scaliness using a 5-point scale (0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, 4= Severe).|A PASI90 responder is defined as a subject that achieves 90% reduction from Baseline in the PASI score.|The number of TEAEs adjusted by duration of exposure to study treatment is scaled such that it provides an incidence rate per 100 patient-years. If a subject has multiple events, the time of exposure is calculated to the first occurrence of the Adverse Event (AE) being considered. If a subject has no events, the total time at risk is used.|The number of SAEs adjusted by duration of exposure to study treatment is scaled such that it provides an incidence rate per 100 patient-years. If a subject has multiple events, the time of exposure is calculated to the first occurrence of the AE being considered. If a subject has no events, the total time at risk is used.|The number of TEAEs leading to discontinuation adjusted by duration of exposure to study treatment is scaled such that it provides an incidence rate per 100 patient-years. If a subject has multiple events, the time of exposure is calculated to the first occurrence of the AE being considered. If a subject has no events, the total time at risk is used.","Week 16|Week 4|Week 56|From Baseline to Safety Follow Up (up to Week 76)",{"$nulls":3},"Carlton, Australia Ps0013 008East Melbourne, Australia|Ajax, Canada Ps0013 672Edmonton, Canada Ps0013 671Hamilton, Canada Ps0013 675Markham, Canada Ps0013 663Mississauga, Canada Ps0013 660MontrÃ©al, Canada Ps0013 668North Bay, Canada Ps0013 667Ottawa, Canada Ps0013 665QuÃ©bec, Canada Ps0013 676Surrey, Canada Ps0013 657Waterloo, Canada|Hamburg, Germany Ps0013 220Hamburg, Germany Ps0013 219MÃ¼nster, Germany Ps0013 200Schwerin, Germany Ps0013 204Witten, Germany|Budapest, Hungary Ps0013 262Miskolc, Hungary Ps0013 253OroshÃ¡za, Hungary Ps0013 260Szeged, Hungary Ps0013 250Szolnok, Hungary Ps0013 258VeszprÃ©m, Hungary Korea, Republic Of Ps0013 701Busan, Korea, Republic Of Ps0013 705Seongnam-Si, Korea, Republic Of Ps0013 703Seoul, Korea, Republic Of|BiaÅ‚ystok, Poland Ps0013 361BiaÅ‚ystok, Poland Ps0013 369BiaÅ‚ystok, Poland Ps0013 352GdaÅ„sk, Poland Ps0013 358Katowice, Poland Ps0013 359Katowice, Poland Ps0013 366Katowice, Poland Ps0013 357Kielce, Poland Ps0013 363KrakÃ³w, Poland Ps0013 356Lublin, Poland Ps0013 374PoznaÅ„, Poland Ps0013 353Szczecin, Poland Ps0013 350Warsaw, Poland Ps0013 351Warsaw, Poland Ps0013 354Warszawa, Poland Ps0013 365WrocÅ‚aw, Poland Ps0013 368WrocÅ‚aw, Poland Ps0013 370WrocÅ‚aw, Poland Ps0013 360Å\u0081Ã³dÅº, Poland Russian Federation Ps0013 400Moscow, Russian Federation Ps0013 402Moscow, Russian Federation Ps0013 403Moscow, Russian Federation Ps0013 404Saint Petersburg, Russian Federation Ps0013 405Saint Petersburg, Russian Federation Ps0013 401Saratov, Russian Federation Ps0013 406Yaroslavl, Russian Federation|Manchester, United Kingdom Ps0013 554Reading, United Kingdom Ps0013 555Salford, United Kingdom|San Diego, California, United States, 92103 Ps0013 955San Diego, California, United States, 92123 Ps0013 967Santa Monica, California, United States, 90404|Fort Myers, Florida, United States, 33912|Sandy Springs, Georgia, United States, 30329|Skokie, Illinois, United States, 60077|Owensboro, Kentucky, United States, 42303|New Orleans, Louisiana, United States, 70115|Beverly, Massachusetts, United States, 01915|Portsmouth, New Hampshire, United States, 03801|Verona, New Jersey, United States, 07044-2946|Buffalo, New York, United States, 14221 Ps0013 968New York, New York, United States, 10021 Ps0013 965New York, New York, United States, 10025 Ps0013 963Rochester, New York, United States, 14623|Cleveland, Ohio, United States, 44106-1716|Portland, Oregon, United States, 97223|Johnston, Rhode Island, United States, 02919|San Antonio, Texas, United States, 78213|Murray, Utah, United States, 84107","California|Florida|Georgia|Illinois|Kentucky|Louisiana|Massachusetts|New Hampshire|New Jersey|New York|Ohio|Oregon|Rhode Island|Texas|Utah","Australia|Canada|Germany|Hungary|Poland|United Kingdom|United States","Ps0013 003|Ps0013 658|Ps0013 202|Ps0013 261|Ps0013 355|Ps0013 550|Ps0013 919|Ps0013 928|Ps0013 966|Ps0013 954|Ps0013 962|Ps0013 944|Ps0013 940|Ps0013 901|Ps0013 956|Ps0013 947|Ps0013 949|Ps0013 929|Ps0013 937|Ps0013 914|Ps0013 933",{"$nulls":3},"UCB Cares","2019-03-01","2020-05-25T16:38:45.569","2020-05-26T17:10:42.972","NCT03410992"]
["5ecbf495fe30261b1a048353","NCT03410992","2019-08-30","UCB","UCBJF","Active, not recruiting","A Study With a Initial Treatment Period Followed by a Randomized-withdrawal Period to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis (BE READY)","Bimekizumab","IL17A Inhibitor","Yes","['Bimekizumab']","No",null,"Phase 3",2,435,"Actual","2018-02-05","2018-12-28","PASI","Psoriasis Area and Severity Index",{"$nulls":3},"Phase 3 study to compare the efficacy of bimekizumab versus placebo in the treatment of subjects with moderate to severe chronic plaque psoriasis.",null,"A Phase 3, Multicenter, Double-Blind, Placebo-Controlled Study With an Initial Treatment Period Followed by a Randomized-Withdrawal Period to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis","PS0013","Chronic Plaque Psoriasis\nModerate to Severe Chronic Plaque Psoriasis\nPsoriatic Arthritis","Arthritis|Psoriasis|Arthritis, Psoriatic","Joint Diseases|Dermatological Diseases|Bone Diseases","Musculoskeletal|Derm & Connective Tissue Disorders","Experimental|Placebo Comparator","Bimekizumab cohort|Placebo","Subjects will receive bimekizumab for 16 Weeks. Subjects who achieve certain predefined response criteria will be re-randomized to either receive bimekizumab or placebo until Week 56. Subjects who do not achieve predefined response criteria will enter the bimekizumab escape arm.|Subjects will receive placebo for 16 Weeks. Subjects who achieve certain predefined response criteria will proceed with placebo until Week 56. Subjects who do not achieve certain predefined response criteria will enter the bimekizumab escape arm.","Drug","Bimekizumab|Placebo","Bimekizumab will be provided at pre-specified time intervals.|Subjects will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products.","UCB4940\nPlaceboSubjects will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products.|PBO","Bimekizumab cohort|Placebo","\n\n * Must be at least 18 years of age\n * Chronic plaque psoriasis (PSO) for at least 6 months prior to the Screening Visit\n * Psoriasis Area Severity Index (PASI) >=12 and body surface area (BSA) affected by PSO >=10% and Investigator's Global Assessment (IGA) score >=3 on a 5-point scale\n * Subject is a candidate for systemic PSO therapy and/or phototherapy\n * Female subject of child bearing potential must be willing to use highly effective method of contraception\n\n","\n\n * Subject has an active infection (except common cold), a recent serious infection, or a history of opportunistic, recurrent, or chronic infections\n * Subject has concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection\n * Subject has known tuberculosis (TB) infection, is at high risk of acquiring TB infection, or has current or history of nontuberculous mycobacterium (NTMB) infection\n * Subject has any other condition, including medical or psychiatric, which, in the Investigator's judgment, would make the subject unsuitable for inclusion in the study\n * Presence of active suicidal ideation or positive suicide behavior\n * Presence of moderately severe major depression or severe major depression\n * Subject has any active malignancy or history of malignancy within 5 years prior to the Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma, or in situ cervical cancer",{"$nulls":4},"Actual","2018-01-25","Actual","Actual","2020-01-01","Anticipated","2019-08-01","2018-01-19","2018-01-19","2019-08-29","Yes","Bimekizumab\nPSO\nPsoriasis","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"All",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2016-003426-16","EudraCT Number","Psoriasis Area and Severity Index 90 (PASI90) response at Week 16|Investigator's Global Assessment (IGA) response at Week 16","A PASI90 responder is defined as a subject that achieves 90% reduction from Baseline in the PASI score.|IGA response is defined as Clear or Almost Clear with at least a 2-category improvement relative to Baseline.","Week 16","PASI100 response at Week 16|PASI75 response at Week 4|Change from Baseline in the Patient Symptom Diary responses for itch at Week 16|Change from Baseline in the Patient Symptom Diary responses for pain at Week 16|Change from Baseline in the Patient Symptom Diary responses for scaling at Week 16|IGA response (Clear or Almost Clear) at Week 16 for subjects with scalp psoriasis (PSO) at Baseline|PASI90 response at Week 56 among Week 16 PASI90 responders|Number of Treatment Emergent Adverse Events (TEAEs) adjusted by duration of subject exposure to study treatment|Number of Serious Adverse Events (SAEs) adjusted by duration of subject exposure to study treatment|Number of TEAEs leading to withdrawal adjusted by duration of subject exposure to study treatment","A PASI100 responder is defined as a subject that achieves 100% reduction from Baseline in the PASI score.|A PASI75 responder is defined as a subject that achieves 75% reduction from Baseline in the PASI score.|A Patient-Reported outcome (PRO) measure will be used to assess key symptoms relevant to patients with moderate to severe chronic plaque PSO. Site staff will train the participating subjects on the use of the electronic PRO (ePRO) diary at the Screening Visit, following which the device will be dispensed to the subject for home use until the Week 16 Visit. The ePRO diary will be administered on a daily basis from Screening to the Week 16 Visit.|A PRO measure will be used to assess key symptoms relevant to patients with moderate to severe chronic plaque PSO. Site staff will train the participating subjects on the use of the electronic PRO (ePRO) diary at the Screening Visit, following which the device will be dispensed to the subject for home use until the Week 16 Visit. The ePRO diary will be administered on a daily basis from Screening to the Week 16 Visit.|Only subjects with scalp involvement at Baseline will complete the scalp IGA. Subjects with scalp involvement at Baseline are defined as those with a scalp IGA score >0 at Baseline. Scalp lesions will be assessed in terms of clinical signs of redness, thickness, and scaliness using a 5-point scale (0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, 4= Severe).|A PASI90 responder is defined as a subject that achieves 90% reduction from Baseline in the PASI score.|The number of TEAEs adjusted by duration of exposure to study treatment is scaled such that it provides an incidence rate per 100 patient-years. If a subject has multiple events, the time of exposure is calculated to the first occurrence of the Adverse Event (AE) being considered. If a subject has no events, the total time at risk is used.|The number of SAEs adjusted by duration of exposure to study treatment is scaled such that it provides an incidence rate per 100 patient-years. If a subject has multiple events, the time of exposure is calculated to the first occurrence of the AE being considered. If a subject has no events, the total time at risk is used.|The number of TEAEs leading to discontinuation adjusted by duration of exposure to study treatment is scaled such that it provides an incidence rate per 100 patient-years. If a subject has multiple events, the time of exposure is calculated to the first occurrence of the AE being considered. If a subject has no events, the total time at risk is used.","Week 16|Week 4|Week 56|From Baseline to Safety Follow Up (up to Week 76)",{"$nulls":3},"Carlton, Australia Ps0013 008East Melbourne, Australia|Ajax, Canada Ps0013 672Edmonton, Canada Ps0013 671Hamilton, Canada Ps0013 675Markham, Canada Ps0013 663Mississauga, Canada Ps0013 660MontrÃ©al, Canada Ps0013 668North Bay, Canada Ps0013 667Ottawa, Canada Ps0013 665QuÃ©bec, Canada Ps0013 676Surrey, Canada Ps0013 657Waterloo, Canada|Hamburg, Germany Ps0013 220Hamburg, Germany Ps0013 219MÃ¼nster, Germany Ps0013 200Schwerin, Germany Ps0013 204Witten, Germany|Budapest, Hungary Ps0013 262Miskolc, Hungary Ps0013 253OroshÃ¡za, Hungary Ps0013 260Szeged, Hungary Ps0013 250Szolnok, Hungary Ps0013 258VeszprÃ©m, Hungary Korea, Republic Of Ps0013 701Busan, Korea, Republic Of Ps0013 705Seongnam-Si, Korea, Republic Of Ps0013 703Seoul, Korea, Republic Of|BiaÅ‚ystok, Poland Ps0013 361BiaÅ‚ystok, Poland Ps0013 369BiaÅ‚ystok, Poland Ps0013 352GdaÅ„sk, Poland Ps0013 358Katowice, Poland Ps0013 359Katowice, Poland Ps0013 366Katowice, Poland Ps0013 357Kielce, Poland Ps0013 363KrakÃ³w, Poland Ps0013 356Lublin, Poland Ps0013 374PoznaÅ„, Poland Ps0013 353Szczecin, Poland Ps0013 350Warsaw, Poland Ps0013 351Warsaw, Poland Ps0013 354Warszawa, Poland Ps0013 365WrocÅ‚aw, Poland Ps0013 368WrocÅ‚aw, Poland Ps0013 370WrocÅ‚aw, Poland Ps0013 360Å\u0081Ã³dÅº, Poland Russian Federation Ps0013 400Moscow, Russian Federation Ps0013 402Moscow, Russian Federation Ps0013 403Moscow, Russian Federation Ps0013 404Saint Petersburg, Russian Federation Ps0013 405Saint Petersburg, Russian Federation Ps0013 401Saratov, Russian Federation Ps0013 406Yaroslavl, Russian Federation|Manchester, United Kingdom Ps0013 554Reading, United Kingdom Ps0013 555Salford, United Kingdom|San Diego, California, United States, 92103 Ps0013 955San Diego, California, United States, 92123 Ps0013 967Santa Monica, California, United States, 90404|Fort Myers, Florida, United States, 33912|Sandy Springs, Georgia, United States, 30329|Skokie, Illinois, United States, 60077|Owensboro, Kentucky, United States, 42303|New Orleans, Louisiana, United States, 70115|Beverly, Massachusetts, United States, 01915|Portsmouth, New Hampshire, United States, 03801|Verona, New Jersey, United States, 07044-2946|Buffalo, New York, United States, 14221 Ps0013 968New York, New York, United States, 10021 Ps0013 965New York, New York, United States, 10025 Ps0013 963Rochester, New York, United States, 14623|Cleveland, Ohio, United States, 44106-1716|Portland, Oregon, United States, 97223|Johnston, Rhode Island, United States, 02919|San Antonio, Texas, United States, 78213|Murray, Utah, United States, 84107","California|Florida|Georgia|Illinois|Kentucky|Louisiana|Massachusetts|New Hampshire|New Jersey|New York|Ohio|Oregon|Rhode Island|Texas|Utah","Australia|Canada|Germany|Hungary|Poland|United Kingdom|United States","Ps0013 003|Ps0013 658|Ps0013 202|Ps0013 261|Ps0013 355|Ps0013 550|Ps0013 919|Ps0013 928|Ps0013 966|Ps0013 954|Ps0013 962|Ps0013 944|Ps0013 940|Ps0013 901|Ps0013 956|Ps0013 947|Ps0013 949|Ps0013 929|Ps0013 937|Ps0013 914|Ps0013 933",{"$nulls":3},"UCB Cares","2019-08-29","2020-05-25T16:38:45.831","2020-05-26T17:10:42.972","NCT03410992"]
["5ecbf495feab101b15530982","NCT03410992","2019-09-20","UCB","UCBJF","Active, not recruiting","A Study With a Initial Treatment Period Followed by a Randomized-withdrawal Period to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis (BE READY)","Bimekizumab","IL17A Inhibitor","Yes","['Bimekizumab']","No",null,"Phase 3",2,435,"Actual","2018-02-05","2018-12-28","PASI","Psoriasis Area and Severity Index",{"$nulls":3},"Phase 3 study to compare the efficacy of bimekizumab versus placebo in the treatment of subjects with moderate to severe chronic plaque psoriasis.",null,"A Phase 3, Multicenter, Double-Blind, Placebo-Controlled Study With an Initial Treatment Period Followed by a Randomized-Withdrawal Period to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis","PS0013","Chronic Plaque Psoriasis\nModerate to Severe Chronic Plaque Psoriasis\nPsoriatic Arthritis","Arthritis|Psoriasis|Arthritis, Psoriatic","Joint Diseases|Dermatological Diseases|Bone Diseases","Musculoskeletal|Derm & Connective Tissue Disorders","Experimental|Placebo Comparator","Bimekizumab cohort|Placebo","Subjects will receive bimekizumab for 16 Weeks. Subjects who achieve certain predefined response criteria will be re-randomized to either receive bimekizumab or placebo until Week 56. Subjects who do not achieve predefined response criteria will enter the bimekizumab escape arm.|Subjects will receive placebo for 16 Weeks. Subjects who achieve certain predefined response criteria will proceed with placebo until Week 56. Subjects who do not achieve certain predefined response criteria will enter the bimekizumab escape arm.","Drug","Bimekizumab|Placebo","Bimekizumab will be provided at pre-specified time intervals.|Subjects will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products.","UCB4940\nPlaceboSubjects will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products.|PBO","Bimekizumab cohort|Placebo","\n\n * Must be at least 18 years of age\n * Chronic plaque psoriasis (PSO) for at least 6 months prior to the Screening Visit\n * Psoriasis Area Severity Index (PASI) >=12 and body surface area (BSA) affected by PSO >=10% and Investigator's Global Assessment (IGA) score >=3 on a 5-point scale\n * Subject is a candidate for systemic PSO therapy and/or phototherapy\n * Female subject of child bearing potential must be willing to use highly effective method of contraception\n\n","\n\n * Subject has an active infection (except common cold), a recent serious infection, or a history of opportunistic, recurrent, or chronic infections\n * Subject has concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection\n * Subject has known tuberculosis (TB) infection, is at high risk of acquiring TB infection, or has current or history of nontuberculous mycobacterium (NTMB) infection\n * Subject has any other condition, including medical or psychiatric, which, in the Investigator's judgment, would make the subject unsuitable for inclusion in the study\n * Presence of active suicidal ideation or positive suicide behavior\n * Presence of moderately severe major depression or severe major depression\n * Subject has any active malignancy or history of malignancy within 5 years prior to the Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma, or in situ cervical cancer",{"$nulls":4},"Actual","2018-01-25","Actual","Actual","2020-01-01","Anticipated","2019-09-01","2018-01-19","2018-01-19","2019-09-19","Yes","Bimekizumab\nPSO\nPsoriasis","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"All",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2016-003426-16","EudraCT Number","Psoriasis Area and Severity Index 90 (PASI90) response at Week 16|Investigator's Global Assessment (IGA) response at Week 16","A PASI90 responder is defined as a subject that achieves 90% reduction from Baseline in the PASI score.|IGA response is defined as Clear or Almost Clear with at least a 2-category improvement relative to Baseline.","Week 16","PASI100 response at Week 16|PASI75 response at Week 4|Change from Baseline in the Patient Symptom Diary responses for itch at Week 16|Change from Baseline in the Patient Symptom Diary responses for pain at Week 16|Change from Baseline in the Patient Symptom Diary responses for scaling at Week 16|IGA response (Clear or Almost Clear) at Week 16 for subjects with scalp psoriasis (PSO) at Baseline|PASI90 response at Week 56 among Week 16 PASI90 responders|Number of Treatment Emergent Adverse Events (TEAEs) adjusted by duration of subject exposure to study treatment|Number of Serious Adverse Events (SAEs) adjusted by duration of subject exposure to study treatment|Number of TEAEs leading to withdrawal adjusted by duration of subject exposure to study treatment","A PASI100 responder is defined as a subject that achieves 100% reduction from Baseline in the PASI score.|A PASI75 responder is defined as a subject that achieves 75% reduction from Baseline in the PASI score.|A Patient-Reported outcome (PRO) measure will be used to assess key symptoms relevant to patients with moderate to severe chronic plaque PSO. Site staff will train the participating subjects on the use of the electronic PRO (ePRO) diary at the Screening Visit, following which the device will be dispensed to the subject for home use until the Week 16 Visit. The ePRO diary will be administered on a daily basis from Screening to the Week 16 Visit.|A PRO measure will be used to assess key symptoms relevant to patients with moderate to severe chronic plaque PSO. Site staff will train the participating subjects on the use of the electronic PRO (ePRO) diary at the Screening Visit, following which the device will be dispensed to the subject for home use until the Week 16 Visit. The ePRO diary will be administered on a daily basis from Screening to the Week 16 Visit.|Only subjects with scalp involvement at Baseline will complete the scalp IGA. Subjects with scalp involvement at Baseline are defined as those with a scalp IGA score >0 at Baseline. Scalp lesions will be assessed in terms of clinical signs of redness, thickness, and scaliness using a 5-point scale (0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, 4= Severe).|A PASI90 responder is defined as a subject that achieves 90% reduction from Baseline in the PASI score.|The number of TEAEs adjusted by duration of exposure to study treatment is scaled such that it provides an incidence rate per 100 patient-years. If a subject has multiple events, the time of exposure is calculated to the first occurrence of the Adverse Event (AE) being considered. If a subject has no events, the total time at risk is used.|The number of SAEs adjusted by duration of exposure to study treatment is scaled such that it provides an incidence rate per 100 patient-years. If a subject has multiple events, the time of exposure is calculated to the first occurrence of the AE being considered. If a subject has no events, the total time at risk is used.|The number of TEAEs leading to discontinuation adjusted by duration of exposure to study treatment is scaled such that it provides an incidence rate per 100 patient-years. If a subject has multiple events, the time of exposure is calculated to the first occurrence of the AE being considered. If a subject has no events, the total time at risk is used.","Week 16|Week 4|Week 56|From Baseline to Safety Follow Up (up to Week 76)",{"$nulls":3},"Carlton, Australia Ps0013 008East Melbourne, Australia|Ajax, Canada Ps0013 672Edmonton, Canada Ps0013 671Hamilton, Canada Ps0013 675Markham, Canada Ps0013 663Mississauga, Canada Ps0013 660MontrÃ©al, Canada Ps0013 668North Bay, Canada Ps0013 667Ottawa, Canada Ps0013 665QuÃ©bec, Canada Ps0013 676Surrey, Canada Ps0013 657Waterloo, Canada|Hamburg, Germany Ps0013 220Hamburg, Germany Ps0013 219MÃ¼nster, Germany Ps0013 200Schwerin, Germany Ps0013 204Witten, Germany|Budapest, Hungary Ps0013 262Miskolc, Hungary Ps0013 253OroshÃ¡za, Hungary Ps0013 260Szeged, Hungary Ps0013 250Szolnok, Hungary Ps0013 258VeszprÃ©m, Hungary Korea, Republic Of Ps0013 701Busan, Korea, Republic Of Ps0013 705Seongnam-Si, Korea, Republic Of Ps0013 703Seoul, Korea, Republic Of|BiaÅ‚ystok, Poland Ps0013 361BiaÅ‚ystok, Poland Ps0013 369BiaÅ‚ystok, Poland Ps0013 352GdaÅ„sk, Poland Ps0013 358Katowice, Poland Ps0013 359Katowice, Poland Ps0013 366Katowice, Poland Ps0013 357Kielce, Poland Ps0013 363KrakÃ³w, Poland Ps0013 356Lublin, Poland Ps0013 374PoznaÅ„, Poland Ps0013 353Szczecin, Poland Ps0013 350Warsaw, Poland Ps0013 351Warsaw, Poland Ps0013 354Warszawa, Poland Ps0013 365WrocÅ‚aw, Poland Ps0013 368WrocÅ‚aw, Poland Ps0013 370WrocÅ‚aw, Poland Ps0013 360Å\u0081Ã³dÅº, Poland Russian Federation Ps0013 400Moscow, Russian Federation Ps0013 402Moscow, Russian Federation Ps0013 403Moscow, Russian Federation Ps0013 404Saint Petersburg, Russian Federation Ps0013 405Saint Petersburg, Russian Federation Ps0013 401Saratov, Russian Federation Ps0013 406Yaroslavl, Russian Federation|Manchester, United Kingdom Ps0013 554Reading, United Kingdom Ps0013 555Salford, United Kingdom|San Diego, California, United States, 92103 Ps0013 955San Diego, California, United States, 92123 Ps0013 967Santa Monica, California, United States, 90404|Fort Myers, Florida, United States, 33912|Sandy Springs, Georgia, United States, 30329|Skokie, Illinois, United States, 60077|Owensboro, Kentucky, United States, 42303|New Orleans, Louisiana, United States, 70115|Beverly, Massachusetts, United States, 01915|Portsmouth, New Hampshire, United States, 03801|Verona, New Jersey, United States, 07044-2946|Buffalo, New York, United States, 14221 Ps0013 968New York, New York, United States, 10021 Ps0013 965New York, New York, United States, 10025 Ps0013 963Rochester, New York, United States, 14623|Cleveland, Ohio, United States, 44106-1716|Portland, Oregon, United States, 97223|Johnston, Rhode Island, United States, 02919|San Antonio, Texas, United States, 78213|Murray, Utah, United States, 84107","California|Florida|Georgia|Illinois|Kentucky|Louisiana|Massachusetts|New Hampshire|New Jersey|New York|Ohio|Oregon|Rhode Island|Texas|Utah","Australia|Canada|Germany|Hungary|Poland|United Kingdom|United States","Ps0013 003|Ps0013 658|Ps0013 202|Ps0013 261|Ps0013 355|Ps0013 550|Ps0013 919|Ps0013 928|Ps0013 966|Ps0013 954|Ps0013 962|Ps0013 944|Ps0013 940|Ps0013 901|Ps0013 956|Ps0013 947|Ps0013 949|Ps0013 929|Ps0013 937|Ps0013 914|Ps0013 933",{"$nulls":3},"UCB Cares","2019-09-19","2020-05-25T16:38:45.976","2020-05-26T17:10:42.972","NCT03410992"]
["5ecbf496307e3d1b1f8d9de5","NCT03410992","2019-10-25","UCB","UCBJF","Active, not recruiting","A Study With a Initial Treatment Period Followed by a Randomized-withdrawal Period to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis (BE READY)","Bimekizumab","IL17A Inhibitor","Yes","['Bimekizumab']","No",null,"Phase 3",2,435,"Actual","2018-02-05","2018-12-28","PASI","Psoriasis Area and Severity Index",{"$nulls":3},"Phase 3 study to compare the efficacy of bimekizumab versus placebo in the treatment of subjects with moderate to severe chronic plaque psoriasis.",null,"A Phase 3, Multicenter, Double-Blind, Placebo-Controlled Study With an Initial Treatment Period Followed by a Randomized-Withdrawal Period to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis","PS0013","Chronic Plaque Psoriasis\nModerate to Severe Chronic Plaque Psoriasis\nPsoriatic Arthritis","Arthritis|Psoriasis|Arthritis, Psoriatic","Joint Diseases|Dermatological Diseases|Bone Diseases","Musculoskeletal|Derm & Connective Tissue Disorders","Experimental|Placebo Comparator","Bimekizumab cohort|Placebo","Subjects will receive bimekizumab for 16 Weeks. Subjects who achieve certain predefined response criteria will be re-randomized to either receive bimekizumab or placebo until Week 56. Subjects who do not achieve predefined response criteria will enter the bimekizumab escape arm.|Subjects will receive placebo for 16 Weeks. Subjects who achieve certain predefined response criteria will proceed with placebo until Week 56. Subjects who do not achieve certain predefined response criteria will enter the bimekizumab escape arm.","Drug","Bimekizumab|Placebo","Bimekizumab will be provided at pre-specified time intervals.|Subjects will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products.","UCB4940\nPlaceboSubjects will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products.|PBO","Bimekizumab cohort|Placebo","\n\n * Must be at least 18 years of age\n * Chronic plaque psoriasis (PSO) for at least 6 months prior to the Screening Visit\n * Psoriasis Area Severity Index (PASI) >=12 and body surface area (BSA) affected by PSO >=10% and Investigator's Global Assessment (IGA) score >=3 on a 5-point scale\n * Subject is a candidate for systemic PSO therapy and/or phototherapy\n * Female subject of child bearing potential must be willing to use highly effective method of contraception\n\n","\n\n * Subject has an active infection (except common cold), a recent serious infection, or a history of opportunistic, recurrent, or chronic infections\n * Subject has concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection\n * Subject has known tuberculosis (TB) infection, is at high risk of acquiring TB infection, or has current or history of nontuberculous mycobacterium (NTMB) infection\n * Subject has any other condition, including medical or psychiatric, which, in the Investigator's judgment, would make the subject unsuitable for inclusion in the study\n * Presence of active suicidal ideation or positive suicide behavior\n * Presence of moderately severe major depression or severe major depression\n * Subject has any active malignancy or history of malignancy within 5 years prior to the Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma, or in situ cervical cancer",{"$nulls":4},"Actual","2018-01-25","Actual","Actual","2020-01-01","Anticipated","2019-10-01","2018-01-19","2018-01-19","2019-10-24","Yes","Bimekizumab\nPSO\nPsoriasis","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"All",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2016-003426-16","EudraCT Number","Psoriasis Area and Severity Index 90 (PASI90) response at Week 16|Investigator's Global Assessment (IGA) response at Week 16","A PASI90 responder is defined as a subject that achieves 90% reduction from Baseline in the PASI score.|IGA response is defined as Clear or Almost Clear with at least a 2-category improvement relative to Baseline.","Week 16","PASI100 response at Week 16|PASI75 response at Week 4|Change from Baseline in the Patient Symptom Diary responses for itch at Week 16|Change from Baseline in the Patient Symptom Diary responses for pain at Week 16|Change from Baseline in the Patient Symptom Diary responses for scaling at Week 16|IGA response (Clear or Almost Clear) at Week 16 for subjects with scalp psoriasis (PSO) at Baseline|PASI90 response at Week 56 among Week 16 PASI90 responders|Number of Treatment Emergent Adverse Events (TEAEs) adjusted by duration of subject exposure to study treatment|Number of Serious Adverse Events (SAEs) adjusted by duration of subject exposure to study treatment|Number of TEAEs leading to withdrawal adjusted by duration of subject exposure to study treatment","A PASI100 responder is defined as a subject that achieves 100% reduction from Baseline in the PASI score.|A PASI75 responder is defined as a subject that achieves 75% reduction from Baseline in the PASI score.|A Patient-Reported outcome (PRO) measure will be used to assess key symptoms relevant to patients with moderate to severe chronic plaque PSO. Site staff will train the participating subjects on the use of the electronic PRO (ePRO) diary at the Screening Visit, following which the device will be dispensed to the subject for home use until the Week 16 Visit. The ePRO diary will be administered on a daily basis from Screening to the Week 16 Visit.|A PRO measure will be used to assess key symptoms relevant to patients with moderate to severe chronic plaque PSO. Site staff will train the participating subjects on the use of the electronic PRO (ePRO) diary at the Screening Visit, following which the device will be dispensed to the subject for home use until the Week 16 Visit. The ePRO diary will be administered on a daily basis from Screening to the Week 16 Visit.|Only subjects with scalp involvement at Baseline will complete the scalp IGA. Subjects with scalp involvement at Baseline are defined as those with a scalp IGA score >0 at Baseline. Scalp lesions will be assessed in terms of clinical signs of redness, thickness, and scaliness using a 5-point scale (0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, 4= Severe).|A PASI90 responder is defined as a subject that achieves 90% reduction from Baseline in the PASI score.|The number of TEAEs adjusted by duration of exposure to study treatment is scaled such that it provides an incidence rate per 100 patient-years. If a subject has multiple events, the time of exposure is calculated to the first occurrence of the Adverse Event (AE) being considered. If a subject has no events, the total time at risk is used.|The number of SAEs adjusted by duration of exposure to study treatment is scaled such that it provides an incidence rate per 100 patient-years. If a subject has multiple events, the time of exposure is calculated to the first occurrence of the AE being considered. If a subject has no events, the total time at risk is used.|The number of TEAEs leading to discontinuation adjusted by duration of exposure to study treatment is scaled such that it provides an incidence rate per 100 patient-years. If a subject has multiple events, the time of exposure is calculated to the first occurrence of the AE being considered. If a subject has no events, the total time at risk is used.","Week 16|Week 4|Week 56|From Baseline to Safety Follow Up (up to Week 76)",{"$nulls":3},"Carlton, Australia Ps0013 008East Melbourne, Australia Ps0013 006Kogarah, Australia|Ajax, Canada Ps0013 672Edmonton, Canada Ps0013 671Hamilton, Canada Ps0013 675Markham, Canada Ps0013 663Mississauga, Canada Ps0013 660MontrÃ©al, Canada Ps0013 668North Bay, Canada Ps0013 667Ottawa, Canada Ps0013 665QuÃ©bec, Canada Ps0013 676Surrey, Canada Ps0013 657Waterloo, Canada|Hamburg, Germany Ps0013 220Hamburg, Germany Ps0013 219MÃ¼nster, Germany Ps0013 200Schwerin, Germany Ps0013 204Witten, Germany|Budapest, Hungary Ps0013 262Miskolc, Hungary Ps0013 253OroshÃ¡za, Hungary Ps0013 260Szeged, Hungary Ps0013 250Szolnok, Hungary Ps0013 258VeszprÃ©m, Hungary Korea, Republic Of Ps0013 701Busan, Korea, Republic Of Ps0013 705Seongnam-Si, Korea, Republic Of Ps0013 703Seoul, Korea, Republic Of|BiaÅ‚ystok, Poland Ps0013 361BiaÅ‚ystok, Poland Ps0013 369BiaÅ‚ystok, Poland Ps0013 352GdaÅ„sk, Poland Ps0013 358Katowice, Poland Ps0013 359Katowice, Poland Ps0013 366Katowice, Poland Ps0013 357Kielce, Poland Ps0013 363KrakÃ³w, Poland Ps0013 356Lublin, Poland Ps0013 374PoznaÅ„, Poland Ps0013 353Szczecin, Poland Ps0013 350Warsaw, Poland Ps0013 351Warsaw, Poland Ps0013 354Warszawa, Poland Ps0013 365WrocÅ‚aw, Poland Ps0013 368WrocÅ‚aw, Poland Ps0013 370WrocÅ‚aw, Poland Ps0013 360Å\u0081Ã³dÅº, Poland Russian Federation Ps0013 400Moscow, Russian Federation Ps0013 402Moscow, Russian Federation Ps0013 403Moscow, Russian Federation Ps0013 404Saint Petersburg, Russian Federation Ps0013 405Saint Petersburg, Russian Federation Ps0013 401Saratov, Russian Federation Ps0013 406Yaroslavl, Russian Federation|Manchester, United Kingdom Ps0013 554Reading, United Kingdom Ps0013 555Salford, United Kingdom|San Diego, California, United States, 92103 Ps0013 955San Diego, California, United States, 92123 Ps0013 967Santa Monica, California, United States, 90404|Fort Myers, Florida, United States, 33912|Sandy Springs, Georgia, United States, 30329|Skokie, Illinois, United States, 60077|Owensboro, Kentucky, United States, 42303|New Orleans, Louisiana, United States, 70115|Beverly, Massachusetts, United States, 01915|Portsmouth, New Hampshire, United States, 03801|Verona, New Jersey, United States, 07044-2946|Buffalo, New York, United States, 14221 Ps0013 968New York, New York, United States, 10021 Ps0013 965New York, New York, United States, 10025 Ps0013 963Rochester, New York, United States, 14623|Cleveland, Ohio, United States, 44106-1716|Portland, Oregon, United States, 97223|Johnston, Rhode Island, United States, 02919|San Antonio, Texas, United States, 78213|Murray, Utah, United States, 84107","California|Florida|Georgia|Illinois|Kentucky|Louisiana|Massachusetts|New Hampshire|New Jersey|New York|Ohio|Oregon|Rhode Island|Texas|Utah","Australia|Canada|Germany|Hungary|Poland|United Kingdom|United States","Ps0013 003|Ps0013 658|Ps0013 202|Ps0013 261|Ps0013 355|Ps0013 550|Ps0013 919|Ps0013 928|Ps0013 966|Ps0013 954|Ps0013 962|Ps0013 944|Ps0013 940|Ps0013 901|Ps0013 956|Ps0013 947|Ps0013 949|Ps0013 929|Ps0013 937|Ps0013 914|Ps0013 933",{"$nulls":3},"UCB Cares","2019-10-24","2020-05-25T16:38:46.428","2020-05-26T17:10:42.972","NCT03410992"]
["5ecbf49611702c1b1b916b61","NCT03410992","2019-11-08","UCB","UCBJF","Active, not recruiting","A Study With a Initial Treatment Period Followed by a Randomized-withdrawal Period to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis (BE READY)","Bimekizumab","IL17A Inhibitor","Yes","['Bimekizumab']","No",null,"Phase 3",2,435,"Actual","2018-02-05","2018-12-28","PASI","Psoriasis Area and Severity Index",{"$nulls":3},"Phase 3 study to compare the efficacy of bimekizumab versus placebo in the treatment of subjects with moderate to severe chronic plaque psoriasis.",null,"A Phase 3, Multicenter, Double-Blind, Placebo-Controlled Study With an Initial Treatment Period Followed by a Randomized-Withdrawal Period to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis","PS0013","Chronic Plaque Psoriasis\nModerate to Severe Chronic Plaque Psoriasis\nPsoriatic Arthritis","Arthritis|Psoriasis|Arthritis, Psoriatic","Joint Diseases|Dermatological Diseases|Bone Diseases","Musculoskeletal|Derm & Connective Tissue Disorders","Experimental|Placebo Comparator","Bimekizumab cohort|Placebo","Subjects will receive bimekizumab for 16 Weeks. Subjects who achieve certain predefined response criteria will be re-randomized to either receive bimekizumab or placebo until Week 56. Subjects who do not achieve predefined response criteria will enter the bimekizumab escape arm.|Subjects will receive placebo for 16 Weeks. Subjects who achieve certain predefined response criteria will proceed with placebo until Week 56. Subjects who do not achieve certain predefined response criteria will enter the bimekizumab escape arm.","Drug","Bimekizumab|Placebo","Bimekizumab will be provided at pre-specified time intervals.|Subjects will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products.","UCB4940\nPlaceboSubjects will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products.|PBO","Bimekizumab cohort|Placebo","\n\n * Must be at least 18 years of age\n * Chronic plaque psoriasis (PSO) for at least 6 months prior to the Screening Visit\n * Psoriasis Area Severity Index (PASI) >=12 and body surface area (BSA) affected by PSO >=10% and Investigator's Global Assessment (IGA) score >=3 on a 5-point scale\n * Subject is a candidate for systemic PSO therapy and/or phototherapy\n * Female subject of child bearing potential must be willing to use highly effective method of contraception\n\n","\n\n * Subject has an active infection (except common cold), a recent serious infection, or a history of opportunistic, recurrent, or chronic infections\n * Subject has concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection\n * Subject has known tuberculosis (TB) infection, is at high risk of acquiring TB infection, or has current or history of nontuberculous mycobacterium (NTMB) infection\n * Subject has any other condition, including medical or psychiatric, which, in the Investigator's judgment, would make the subject unsuitable for inclusion in the study\n * Presence of active suicidal ideation or positive suicide behavior\n * Presence of moderately severe major depression or severe major depression\n * Subject has any active malignancy or history of malignancy within 5 years prior to the Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma, or in situ cervical cancer",{"$nulls":4},"Actual","2018-01-25","Actual","Actual","2020-01-01","Anticipated","2019-11-01","2018-01-19","2018-01-19","2019-11-07","Yes","Bimekizumab\nPSO\nPsoriasis","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"All",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2016-003426-16","EudraCT Number","Psoriasis Area and Severity Index 90 (PASI90) response at Week 16|Investigator's Global Assessment (IGA) response at Week 16","A PASI90 responder is defined as a subject that achieves 90% reduction from Baseline in the PASI score.|IGA response is defined as Clear or Almost Clear with at least a 2-category improvement relative to Baseline.","Week 16","PASI100 response at Week 16|PASI75 response at Week 4|Change from Baseline in the Patient Symptom Diary responses for itch at Week 16|Change from Baseline in the Patient Symptom Diary responses for pain at Week 16|Change from Baseline in the Patient Symptom Diary responses for scaling at Week 16|IGA response (Clear or Almost Clear) at Week 16 for subjects with scalp psoriasis (PSO) at Baseline|PASI90 response at Week 56 among Week 16 PASI90 responders|Number of Treatment Emergent Adverse Events (TEAEs) adjusted by duration of subject exposure to study treatment|Number of Serious Adverse Events (SAEs) adjusted by duration of subject exposure to study treatment|Number of TEAEs leading to withdrawal adjusted by duration of subject exposure to study treatment","A PASI100 responder is defined as a subject that achieves 100% reduction from Baseline in the PASI score.|A PASI75 responder is defined as a subject that achieves 75% reduction from Baseline in the PASI score.|A Patient-Reported outcome (PRO) measure will be used to assess key symptoms relevant to patients with moderate to severe chronic plaque PSO. Site staff will train the participating subjects on the use of the electronic PRO (ePRO) diary at the Screening Visit, following which the device will be dispensed to the subject for home use until the Week 16 Visit. The ePRO diary will be administered on a daily basis from Screening to the Week 16 Visit.|A PRO measure will be used to assess key symptoms relevant to patients with moderate to severe chronic plaque PSO. Site staff will train the participating subjects on the use of the electronic PRO (ePRO) diary at the Screening Visit, following which the device will be dispensed to the subject for home use until the Week 16 Visit. The ePRO diary will be administered on a daily basis from Screening to the Week 16 Visit.|Only subjects with scalp involvement at Baseline will complete the scalp IGA. Subjects with scalp involvement at Baseline are defined as those with a scalp IGA score >0 at Baseline. Scalp lesions will be assessed in terms of clinical signs of redness, thickness, and scaliness using a 5-point scale (0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, 4= Severe).|A PASI90 responder is defined as a subject that achieves 90% reduction from Baseline in the PASI score.|The number of TEAEs adjusted by duration of exposure to study treatment is scaled such that it provides an incidence rate per 100 patient-years. If a subject has multiple events, the time of exposure is calculated to the first occurrence of the Adverse Event (AE) being considered. If a subject has no events, the total time at risk is used.|The number of SAEs adjusted by duration of exposure to study treatment is scaled such that it provides an incidence rate per 100 patient-years. If a subject has multiple events, the time of exposure is calculated to the first occurrence of the AE being considered. If a subject has no events, the total time at risk is used.|The number of TEAEs leading to discontinuation adjusted by duration of exposure to study treatment is scaled such that it provides an incidence rate per 100 patient-years. If a subject has multiple events, the time of exposure is calculated to the first occurrence of the AE being considered. If a subject has no events, the total time at risk is used.","Week 16|Week 4|Week 56|From Baseline to Safety Follow Up (up to Week 76)",{"$nulls":3},"Carlton, Australia Ps0013 008East Melbourne, Australia Ps0013 006Kogarah, Australia|Ajax, Canada Ps0013 672Edmonton, Canada Ps0013 671Hamilton, Canada Ps0013 675Markham, Canada Ps0013 663Mississauga, Canada Ps0013 660MontrÃ©al, Canada Ps0013 668North Bay, Canada Ps0013 667Ottawa, Canada Ps0013 665QuÃ©bec, Canada Ps0013 676Surrey, Canada Ps0013 657Waterloo, Canada|Hamburg, Germany Ps0013 220Hamburg, Germany Ps0013 219MÃ¼nster, Germany Ps0013 200Schwerin, Germany Ps0013 204Witten, Germany|Budapest, Hungary Ps0013 262Miskolc, Hungary Ps0013 253OroshÃ¡za, Hungary Ps0013 260Szeged, Hungary Ps0013 250Szolnok, Hungary Ps0013 258VeszprÃ©m, Hungary Korea, Republic Of Ps0013 701Busan, Korea, Republic Of Ps0013 705Seongnam-Si, Korea, Republic Of Ps0013 703Seoul, Korea, Republic Of|BiaÅ‚ystok, Poland Ps0013 361BiaÅ‚ystok, Poland Ps0013 369BiaÅ‚ystok, Poland Ps0013 352GdaÅ„sk, Poland Ps0013 358Katowice, Poland Ps0013 359Katowice, Poland Ps0013 366Katowice, Poland Ps0013 357Kielce, Poland Ps0013 363KrakÃ³w, Poland Ps0013 356Lublin, Poland Ps0013 374PoznaÅ„, Poland Ps0013 353Szczecin, Poland Ps0013 350Warsaw, Poland Ps0013 351Warsaw, Poland Ps0013 354Warszawa, Poland Ps0013 365WrocÅ‚aw, Poland Ps0013 368WrocÅ‚aw, Poland Ps0013 370WrocÅ‚aw, Poland Ps0013 360Å\u0081Ã³dÅº, Poland Russian Federation Ps0013 400Moscow, Russian Federation Ps0013 402Moscow, Russian Federation Ps0013 403Moscow, Russian Federation Ps0013 404Saint Petersburg, Russian Federation Ps0013 405Saint Petersburg, Russian Federation Ps0013 401Saratov, Russian Federation Ps0013 406Yaroslavl, Russian Federation|Manchester, United Kingdom Ps0013 554Reading, United Kingdom Ps0013 555Salford, United Kingdom|San Diego, California, United States, 92103 Ps0013 955San Diego, California, United States, 92123 Ps0013 967Santa Monica, California, United States, 90404|Fort Myers, Florida, United States, 33912|Sandy Springs, Georgia, United States, 30329|Skokie, Illinois, United States, 60077|Owensboro, Kentucky, United States, 42303|New Orleans, Louisiana, United States, 70115|Beverly, Massachusetts, United States, 01915|Portsmouth, New Hampshire, United States, 03801|Verona, New Jersey, United States, 07044-2946|Buffalo, New York, United States, 14221 Ps0013 968New York, New York, United States, 10021 Ps0013 965New York, New York, United States, 10025 Ps0013 963Rochester, New York, United States, 14623|Cleveland, Ohio, United States, 44106-1716|Portland, Oregon, United States, 97223|Johnston, Rhode Island, United States, 02919|San Antonio, Texas, United States, 78213|Murray, Utah, United States, 84107","California|Florida|Georgia|Illinois|Kentucky|Louisiana|Massachusetts|New Hampshire|New Jersey|New York|Ohio|Oregon|Rhode Island|Texas|Utah","Australia|Canada|Germany|Hungary|Poland|United Kingdom|United States","Ps0013 003|Ps0013 658|Ps0013 202|Ps0013 261|Ps0013 355|Ps0013 550|Ps0013 919|Ps0013 928|Ps0013 966|Ps0013 954|Ps0013 962|Ps0013 944|Ps0013 940|Ps0013 901|Ps0013 956|Ps0013 947|Ps0013 949|Ps0013 929|Ps0013 937|Ps0013 914|Ps0013 933",{"$nulls":3},"UCB Cares","2019-11-07","2020-05-25T16:38:46.284","2020-05-26T17:10:42.972","NCT03410992"]
["5ecbf496e2561b1b11905e4e","NCT03410992","2020-01-27","UCB","UCBJF","Active, not recruiting","A Study With a Initial Treatment Period Followed by a Randomized-withdrawal Period to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis (BE READY)","Bimekizumab","IL17A Inhibitor","Yes","['Bimekizumab']","No",null,"Phase 3",2,435,"Actual","2018-02-05","2018-12-28","PASI","Psoriasis Area and Severity Index",{"$nulls":3},"Phase 3 study to compare the efficacy of bimekizumab versus placebo in the treatment of subjects with moderate to severe chronic plaque psoriasis.",null,"A Phase 3, Multicenter, Double-Blind, Placebo-Controlled Study With an Initial Treatment Period Followed by a Randomized-Withdrawal Period to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis","PS0013","Chronic Plaque Psoriasis\nModerate to Severe Chronic Plaque Psoriasis\nPsoriatic Arthritis","Arthritis|Psoriasis|Arthritis, Psoriatic","Joint Diseases|Dermatological Diseases|Bone Diseases","Musculoskeletal|Derm & Connective Tissue Disorders","Experimental|Placebo Comparator","Bimekizumab cohort|Placebo","Subjects will receive bimekizumab for 16 Weeks. Subjects who achieve certain predefined response criteria will be re-randomized to either receive bimekizumab or placebo until Week 56. Subjects who do not achieve predefined response criteria will enter the bimekizumab escape arm.|Subjects will receive placebo for 16 Weeks. Subjects who achieve certain predefined response criteria will proceed with placebo until Week 56. Subjects who do not achieve certain predefined response criteria will enter the bimekizumab escape arm.","Drug","Bimekizumab|Placebo","Bimekizumab will be provided at pre-specified time intervals.|Subjects will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products.","UCB4940\nPlaceboSubjects will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products.|PBO","Bimekizumab cohort|Placebo","\n\n * Must be at least 18 years of age\n * Chronic plaque psoriasis (PSO) for at least 6 months prior to the Screening Visit\n * Psoriasis Area Severity Index (PASI) >=12 and body surface area (BSA) affected by PSO >=10% and Investigator's Global Assessment (IGA) score >=3 on a 5-point scale\n * Subject is a candidate for systemic PSO therapy and/or phototherapy\n * Female subject of child bearing potential must be willing to use highly effective method of contraception\n\n","\n\n * Subject has an active infection (except common cold), a recent serious infection, or a history of opportunistic, recurrent, or chronic infections\n * Subject has concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection\n * Subject has known tuberculosis (TB) infection, is at high risk of acquiring TB infection, or has current or history of nontuberculous mycobacterium (NTMB) infection\n * Subject has any other condition, including medical or psychiatric, which, in the Investigator's judgment, would make the subject unsuitable for inclusion in the study\n * Presence of active suicidal ideation or positive suicide behavior\n * Presence of moderately severe major depression or severe major depression\n * Subject has any active malignancy or history of malignancy within 5 years prior to the Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma, or in situ cervical cancer",{"$nulls":4},"Actual","2018-01-25","Actual","Actual","2020-01-01","Anticipated","2020-01-01","2018-01-19","2018-01-19","2020-01-20","Yes","Bimekizumab\nPSO\nPsoriasis","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"All",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":4},"No",null,null,43836,43836,"January 7, 2020 [Actual]",{"$nulls":7},"2016-003426-16","EudraCT Number","Psoriasis Area and Severity Index 90 (PASI90) response at Week 16|Investigator's Global Assessment (IGA) response at Week 16","A PASI90 responder is defined as a subject that achieves 90% reduction from Baseline in the PASI score.|IGA response is defined as Clear or Almost Clear with at least a 2-category improvement relative to Baseline.","Week 16","PASI100 response at Week 16|PASI75 response at Week 4|Change from Baseline in the Patient Symptom Diary responses for itch at Week 16|Change from Baseline in the Patient Symptom Diary responses for pain at Week 16|Change from Baseline in the Patient Symptom Diary responses for scaling at Week 16|IGA response (Clear or Almost Clear) at Week 16 for subjects with scalp psoriasis (PSO) at Baseline|PASI90 response at Week 56 among Week 16 PASI90 responders|Number of Treatment Emergent Adverse Events (TEAEs) adjusted by duration of subject exposure to study treatment|Number of Serious Adverse Events (SAEs) adjusted by duration of subject exposure to study treatment|Number of TEAEs leading to withdrawal adjusted by duration of subject exposure to study treatment","A PASI100 responder is defined as a subject that achieves 100% reduction from Baseline in the PASI score.|A PASI75 responder is defined as a subject that achieves 75% reduction from Baseline in the PASI score.|A Patient-Reported outcome (PRO) measure will be used to assess key symptoms relevant to patients with moderate to severe chronic plaque PSO. Site staff will train the participating subjects on the use of the electronic PRO (ePRO) diary at the Screening Visit, following which the device will be dispensed to the subject for home use until the Week 16 Visit. The ePRO diary will be administered on a daily basis from Screening to the Week 16 Visit.|A PRO measure will be used to assess key symptoms relevant to patients with moderate to severe chronic plaque PSO. Site staff will train the participating subjects on the use of the electronic PRO (ePRO) diary at the Screening Visit, following which the device will be dispensed to the subject for home use until the Week 16 Visit. The ePRO diary will be administered on a daily basis from Screening to the Week 16 Visit.|Only subjects with scalp involvement at Baseline will complete the scalp IGA. Subjects with scalp involvement at Baseline are defined as those with a scalp IGA score >0 at Baseline. Scalp lesions will be assessed in terms of clinical signs of redness, thickness, and scaliness using a 5-point scale (0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, 4= Severe).|A PASI90 responder is defined as a subject that achieves 90% reduction from Baseline in the PASI score.|The number of TEAEs adjusted by duration of exposure to study treatment is scaled such that it provides an incidence rate per 100 patient-years. If a subject has multiple events, the time of exposure is calculated to the first occurrence of the Adverse Event (AE) being considered. If a subject has no events, the total time at risk is used.|The number of SAEs adjusted by duration of exposure to study treatment is scaled such that it provides an incidence rate per 100 patient-years. If a subject has multiple events, the time of exposure is calculated to the first occurrence of the AE being considered. If a subject has no events, the total time at risk is used.|The number of TEAEs leading to discontinuation adjusted by duration of exposure to study treatment is scaled such that it provides an incidence rate per 100 patient-years. If a subject has multiple events, the time of exposure is calculated to the first occurrence of the AE being considered. If a subject has no events, the total time at risk is used.","Week 16|Week 4|Week 56|From Baseline to Safety Follow Up (up to Week 76)",{"$nulls":3},"Carlton, Australia Ps0013 008East Melbourne, Australia Ps0013 006Kogarah, Australia|Ajax, Canada Ps0013 672Edmonton, Canada Ps0013 671Hamilton, Canada Ps0013 675Markham, Canada Ps0013 663Mississauga, Canada Ps0013 660MontrÃ©al, Canada Ps0013 668North Bay, Canada Ps0013 667Ottawa, Canada Ps0013 665QuÃ©bec, Canada Ps0013 676Surrey, Canada Ps0013 657Waterloo, Canada|Hamburg, Germany Ps0013 220Hamburg, Germany Ps0013 219MÃ¼nster, Germany Ps0013 200Schwerin, Germany Ps0013 204Witten, Germany|Budapest, Hungary Ps0013 262Miskolc, Hungary Ps0013 253OroshÃ¡za, Hungary Ps0013 260Szeged, Hungary Ps0013 250Szolnok, Hungary Ps0013 258VeszprÃ©m, Hungary Korea, Republic Of Ps0013 701Busan, Korea, Republic Of Ps0013 705Seongnam-Si, Korea, Republic Of Ps0013 703Seoul, Korea, Republic Of|BiaÅ‚ystok, Poland Ps0013 361BiaÅ‚ystok, Poland Ps0013 369BiaÅ‚ystok, Poland Ps0013 352GdaÅ„sk, Poland Ps0013 358Katowice, Poland Ps0013 359Katowice, Poland Ps0013 366Katowice, Poland Ps0013 357Kielce, Poland Ps0013 363KrakÃ³w, Poland Ps0013 356Lublin, Poland Ps0013 374PoznaÅ„, Poland Ps0013 353Szczecin, Poland Ps0013 350Warsaw, Poland Ps0013 351Warsaw, Poland Ps0013 354Warszawa, Poland Ps0013 365WrocÅ‚aw, Poland Ps0013 368WrocÅ‚aw, Poland Ps0013 370WrocÅ‚aw, Poland Ps0013 360Å\u0081Ã³dÅº, Poland Russian Federation Ps0013 400Moscow, Russian Federation Ps0013 402Moscow, Russian Federation Ps0013 403Moscow, Russian Federation Ps0013 404Saint Petersburg, Russian Federation Ps0013 405Saint Petersburg, Russian Federation Ps0013 401Saratov, Russian Federation Ps0013 406Yaroslavl, Russian Federation|Manchester, United Kingdom Ps0013 554Reading, United Kingdom Ps0013 555Salford, United Kingdom|San Diego, California, United States, 92103 Ps0013 955San Diego, California, United States, 92123 Ps0013 967Santa Monica, California, United States, 90404|Fort Myers, Florida, United States, 33912|Sandy Springs, Georgia, United States, 30329|Skokie, Illinois, United States, 60077|Owensboro, Kentucky, United States, 42303|New Orleans, Louisiana, United States, 70115|Beverly, Massachusetts, United States, 01915|Portsmouth, New Hampshire, United States, 03801|Verona, New Jersey, United States, 07044-2946|Buffalo, New York, United States, 14221 Ps0013 968New York, New York, United States, 10021 Ps0013 965New York, New York, United States, 10025 Ps0013 963Rochester, New York, United States, 14623|Cleveland, Ohio, United States, 44106-1716|Portland, Oregon, United States, 97223|Johnston, Rhode Island, United States, 02919|San Antonio, Texas, United States, 78213|Murray, Utah, United States, 84107","California|Florida|Georgia|Illinois|Kentucky|Louisiana|Massachusetts|New Hampshire|New Jersey|New York|Ohio|Oregon|Rhode Island|Texas|Utah","Australia|Canada|Germany|Hungary|Poland|United Kingdom|United States","Ps0013 003|Ps0013 658|Ps0013 202|Ps0013 261|Ps0013 355|Ps0013 550|Ps0013 919|Ps0013 928|Ps0013 966|Ps0013 954|Ps0013 962|Ps0013 944|Ps0013 940|Ps0013 901|Ps0013 956|Ps0013 947|Ps0013 949|Ps0013 929|Ps0013 937|Ps0013 914|Ps0013 933",{"$nulls":3},"UCB Cares","2020-01-20","2020-05-25T16:38:46.541","2020-05-26T17:10:42.972","NCT03410992"]
["5ecbf498fe30261b1a048359","NCT03411473","2018-04-09","Agenus","AGEN","Recruiting","Study of AGEN1884 With Pembrolizumab in 1L NSCLC","Agen-1884|Pembrolizumab","CTLA4 Inhibitor|PD-1 Inhibitor","Yes","['Agen-1884']","No",null,"Phase 2",1,26,"Anticipated","2017-10-04","2020-08-01",{"$nulls":5},"A Phase IIa Open-Label Trial to Investigate the Safety, Tolerability, Pharmacokinetics, Biological, and Clinical Activity of AGEN1884 in Combination with Pembrolizumab in Subjects with Chemotherapy NaÃ¯ve, PD-L1 high, metastatic Non-Small Cell Lung Cancer (NSCLC)","This is a Phase IIa, open-label study, of AGEN1884 in combination with pembrolizumab in subjects with stage IV NSCLC whose tumors have high PD-L1 expression and no EGFR or ALK genomic tumor aberrations.\n\nThe study consists in two phases:\n\n * Safety Run-in Phase\n * Efficacy Phase\n\nSubjects will be enrolled in a \"3+3\" Safety Run-in followed by enrollment completing the efficacy cohort. Two different dose levels of AGEN1884 may be tested in combination with the approved pembrolizumab treatment for this indication (until disease progression, unacceptable toxicity, or up to a maximum of 24 months). Each subject will stay on the dose level assigned at trial entry.","A Phase IIa Open-Label Trial of AGEN1884 in Combination With Pembrolizumab in Subjects With Chemotherapy NaÃ¯ve, PD-L1 High, Metastatic Non-Small Cell Lung Cancer (NSCLC)","C-500-03","NSCLC Stage IV","Non-Small-Cell Lung Cancer","Oncology Solid Tumor","Oncology","Experimental","AGEN1884 with pembrolizumab","AGEN1884 in combination with pembrolizumab","Biological","AGEN1884 in combination with pembrolizumab","AGEN1884 in combination with pembrolizumab in subjects with stage IV NSCLC whose tumors have high PD-L1 expression and no EGFR or ALK genomic tumor aberrations",null,"AGEN1884 with pembrolizumab","\n\n 1.  Voluntarily agree to participate.\n 2.  Be â‰¥18 years of age.\n 3.  Have a histologically or cytologically confirmed diagnosis of NSCLC, is stage IV, does not have an EGFR sensitizing (activating) mutation or ALK translocation, and has not received prior systemic chemotherapy treatment for their metastatic NSCLC.\n 4.  Have measurable disease based on RECIST 1.1 as determined by the site.\n 5.  Have a life expectancy of at least 3 months and a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status\n 6.  Have adequate organ function as indicated by the following laboratory values: 1. Adequate hematological function defined by absolute neutrophil count (ANC) > 1.5 x 109/L, platelet count > 100 x 109/L, and hemoglobin > 9 g/dL (without transfusions within 2 weeks of first dose).\n      2. Adequate hepatic function based by a total bilirubin level < the institutional upper limit of normal (IULN), aspartate aminotransferase (AST) level < 1.5 x IULN, alanine aminotransferase (ALT) level < 1.5 x IULN, and alkaline phosphatase â‰¤ 2.5 ULN.\n      3. Adequate renal function defined as Creatinine â‰¤ 1.5 x IULN OR calculated creatinine clearance > 60 mL/min for subjects with creatinine levels > 1.5 x IULN (If no local guideline is available, creatinine clearance should be calculated using the Cockcroft-Gault Method).\n      4. Adequate coagulation defined by international normalized ratio (INR) or prothrombin time â‰¤ 1.5 x IULN (unless the subject is receiving anticoagulant therapy); and activated partial thromboplastin time (aPTT) â‰¤ 1.5 x IULN (unless the subject is receiving anticoagulant therapy)\n      5. Adequate endocrine function defined by thyroid stimulating hormone (TSH) within normal limits. Note: if TSH is not within normal limits at baseline, the subject may still be eligible if T3 and free T4 are within normal limits.\n     \n     \n 7.  Subject has no history of prior malignancy, with the exception of basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, in situ cervical cancer, or has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since initiation of that therapy.\n 8.  Have provided a formalin fixed tumor tissue sample from a biopsy of a tumor lesion either at the time of or after the diagnosis of metastatic disease has been made AND from a site not previously irradiated to assess for PD-L1 status.\n 9.  The subject's tumor does not harbor an EGFR sensitizing (activating) mutation or ALK translocation.\n 10. The subject's tumor must have high PD-L1 expression (TPS â‰¥50%) as determined by an FDA-approved test.\n 11. Female subjects must have a negative serum pregnancy test at screening (within 72 hours of first dose of study medication) if of childbearing potential or be of non-child bearing potential.\n 12. If of childbearing potential, female subjects must be willing to use two adequate barrier methods throughout the study, starting with the screening visit through 120 days after the last dose of study therapy.\n 13. Male subjects with a female partner(s) of child-bearing potential must agree to use two adequate barrier methods throughout the trial starting with the screening visit through 120 days after the last dose of pembrolizumab is received. Males with pregnant partners must agree to use a condom; no additional method of contraception is required for the pregnant partner.\n 14. Subject is willing and able to comply with the requirements of the protocol.\n\n","\n\n 1.  Has an EGFR sensitizing mutation and/or an ALK translocation.\n 2.  Has received systemic therapy for the treatment of their stage IV NSCLC. Completion of treatment with chemotherapy and/or radiation as part of neoadjuvant/adjuvant therapy is allowed as long as therapy was completed at least 6 months prior to the diagnosis of metastatic disease.\n 3.  Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigation device within 4 weeks of the first dose of treatment.\n 4.  Is receiving systemic steroid therapy < 3 days prior to the first dose of trial treatment or receiving any other form of immunosuppressive medication.\n 5.  Is expected to require any other form of systemic or localized antineoplastic therapy while on trial (including maintenance therapy with another agent for NSCLC, radiation therapy, and/or surgical resection)\n 6.  Has received prior systemic cytotoxic chemotherapy, biological therapy, OR major surgery within 3 weeks of the first dose of trial treatment; received thoracic radiation therapy of > 30 Gy within 6 months of the first dose of trial treatment.\n 7.  Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).\n 8.  Has central nervous system (CNS) metastases and/or carcinomatous meningitis identified either on the baseline brain imaging obtained during the screening period OR identified prior to signing the ICF.\n 9.  Active autoimmune disease that has required systemic treatment in past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (i.e., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.\n 10. Has had an allogeneic tissue/solid organ transplant.\n 11. Has interstitial lung disease (ILD) OR has had a history of pneumonitis that has required oral or IV steroids.\n 12. Has received or will receive a live vaccine within 30 days prior to the first administration of study medication. Seasonal flu vaccines that do not contain a live virus are permitted\n 13. Has an active infection requiring intravenous systemic therapy.\n 14. Has known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).\n 15. Has known active Hepatitis B, Hepatitis C or tuberculosis.\n 16. Has clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke or myocardial infarction within 6 months of enrollment, unstable angina, congestive heart failure (New York Heart Association class â‰¥II), or serious uncontrolled cardiac arrhythmia requiring medication.\n 17. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating Investigator.\n 18. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n 19. Is, at the time of signing informed consent, a regular user (including \"recreational use\") of any illicit drugs or had a recent history (within the last year) of substance abuse (including alcohol).\n 20. Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit (Visit 1) through 120 days after the last dose of pembrolizumab or AGEN1884.","EGFR","epidermal growth factor receptor","Protein","Ovary, Breast, Lung","Actual","2018-01-26","Actual","Anticipated","2021-05-01","Anticipated","2018-04-01","2017-11-14","2018-01-19","2018-04-06","Yes",null,"Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No","Undecided",{"$nulls":3},"No","No",{"$nulls":19},"Occurrence of DLTs in subjects in the Safety Run-in Phase of the trial","Occurrence of DLTs in subjects in the Safety Run-in Phase of the trial","21 days","Frequency, severity, and duration of treatment-emergent AEs (TEAEs)|Frequency, severity, and duration of treatment-related AEs|Confirmed BOR per RECIST 1.1|Duration of response per RECIST 1.1|PFS time|OS time|Unconfirmed response at 12 weeks from first dose per RECIST 1.1|Pharmacokinetic profile of AGEN1884 and pembrolizumab|Immunogenicity of AGEN1884 and pembrolizumab","Frequency, severity, and duration of treatment-emergent AEs (TEAEs)|Frequency, severity, and duration of treatment-related AEs|Confirmed BOR per RECIST 1.1|Duration of response per RECIST 1.1|PFS time|OS time|Unconfirmed response at 12 weeks from first dose per RECIST 1.1|Pharmacokinetic profile of AGEN1884 and pembrolizumab|Immunogenicity of AGEN1884 and pembrolizumab","116 weeks|36 months|June 2020 ( When 14 patients have completed 2 years of treatment)|Up to 24 months from 1st dose of treatment|At least 20 patients have completed 12 weeks from 1st dose of treatment|All patients on study have completed 6 weeks from 1st dose of treatment","sara.coulter@agenusbio.com","Sara Coulter",{"$f":"1-781-674-4480","v":-5934},"Brisbane, Australia Mater ResearchBrisbane, Australia|Auckland, New Zealand",null,"Australia|New Zealand","Icon Cancer Center|Auckland City Hospital",{"$nulls":3},"Edward Dow, MD","2018-04-06","2020-05-25T16:38:48.144","2020-05-26T17:10:42.972","NCT03411473"]
["5ecbf497feab101b15530987","NCT03411473","2020-01-14","Agenus","AGEN","Terminated","Study of AGEN1884 With Pembrolizumab in 1L NSCLC","Agen-1884|Pembrolizumab","CTLA4 Inhibitor|PD-1 Inhibitor","Yes","['Agen-1884']","No",null,"Phase 2",1,2,"Actual","2017-10-04","2018-05-01",{"$nulls":5},"A Phase IIa Open-Label Trial to Investigate the Safety, Tolerability, Pharmacokinetics, Biological, and Clinical Activity of AGEN1884 in Combination with Pembrolizumab in Subjects with Chemotherapy NaÃ¯ve, PD-L1 high, metastatic Non-Small Cell Lung Cancer (NSCLC)","This is a Phase IIa, open-label study, of AGEN1884 in combination with pembrolizumab in subjects with stage IV NSCLC whose tumors have high PD-L1 expression and no EGFR or ALK genomic tumor aberrations.\n\nThe study consists in two phases:\n\n * Safety Run-in Phase\n * Efficacy Phase\n\nSubjects will be enrolled in a \"3+3\" Safety Run-in followed by enrollment completing the efficacy cohort. Two different dose levels of AGEN1884 may be tested in combination with the approved pembrolizumab treatment for this indication (until disease progression, unacceptable toxicity, or up to a maximum of 24 months). Each subject will stay on the dose level assigned at trial entry.","A Phase IIa Open-Label Trial of AGEN1884 in Combination With Pembrolizumab in Subjects With Chemotherapy NaÃ¯ve, PD-L1 High, Metastatic Non-Small Cell Lung Cancer (NSCLC)","C-500-03","NSCLC Stage IV","Non-Small-Cell Lung Cancer","Oncology Solid Tumor","Oncology","Experimental","AGEN1884 with pembrolizumab","AGEN1884 in combination with pembrolizumab","Biological","AGEN1884 in combination with pembrolizumab","AGEN1884 in combination with pembrolizumab in subjects with stage IV NSCLC whose tumors have high PD-L1 expression and no EGFR or ALK genomic tumor aberrations",null,"AGEN1884 with pembrolizumab","\n\n 1.  Voluntarily agree to participate.\n 2.  Be â‰¥18 years of age.\n 3.  Have a histologically or cytologically confirmed diagnosis of NSCLC, is stage IV, does not have an EGFR sensitizing (activating) mutation or ALK translocation, and has not received prior systemic chemotherapy treatment for their metastatic NSCLC.\n 4.  Have measurable disease based on RECIST 1.1 as determined by the site.\n 5.  Have a life expectancy of at least 3 months and a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status\n 6.  Have adequate organ function as indicated by the following laboratory values: 1. Adequate hematological function defined by absolute neutrophil count (ANC) > 1.5 x 109/L, platelet count > 100 x 109/L, and hemoglobin > 9 g/dL (without transfusions within 2 weeks of first dose).\n      2. Adequate hepatic function based by a total bilirubin level < the institutional upper limit of normal (IULN), aspartate aminotransferase (AST) level < 1.5 x IULN, alanine aminotransferase (ALT) level < 1.5 x IULN, and alkaline phosphatase â‰¤ 2.5 ULN.\n      3. Adequate renal function defined as Creatinine â‰¤ 1.5 x IULN OR calculated creatinine clearance > 60 mL/min for subjects with creatinine levels > 1.5 x IULN (If no local guideline is available, creatinine clearance should be calculated using the Cockcroft-Gault Method).\n      4. Adequate coagulation defined by international normalized ratio (INR) or prothrombin time â‰¤ 1.5 x IULN (unless the subject is receiving anticoagulant therapy); and activated partial thromboplastin time (aPTT) â‰¤ 1.5 x IULN (unless the subject is receiving anticoagulant therapy)\n      5. Adequate endocrine function defined by thyroid stimulating hormone (TSH) within normal limits. Note: if TSH is not within normal limits at baseline, the subject may still be eligible if T3 and free T4 are within normal limits.\n     \n     \n 7.  Subject has no history of prior malignancy, with the exception of basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, in situ cervical cancer, or has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since initiation of that therapy.\n 8.  Have provided a formalin fixed tumor tissue sample from a biopsy of a tumor lesion either at the time of or after the diagnosis of metastatic disease has been made AND from a site not previously irradiated to assess for PD-L1 status.\n 9.  The subject's tumor does not harbor an EGFR sensitizing (activating) mutation or ALK translocation.\n 10. The subject's tumor must have high PD-L1 expression (TPS â‰¥50%) as determined by an FDA-approved test.\n 11. Female subjects must have a negative serum pregnancy test at screening (within 72 hours of first dose of study medication) if of childbearing potential or be of non-child bearing potential.\n 12. If of childbearing potential, female subjects must be willing to use two adequate barrier methods throughout the study, starting with the screening visit through 120 days after the last dose of study therapy.\n 13. Male subjects with a female partner(s) of child-bearing potential must agree to use two adequate barrier methods throughout the trial starting with the screening visit through 120 days after the last dose of pembrolizumab is received. Males with pregnant partners must agree to use a condom; no additional method of contraception is required for the pregnant partner.\n 14. Subject is willing and able to comply with the requirements of the protocol.\n\n","\n\n 1.  Has an EGFR sensitizing mutation and/or an ALK translocation.\n 2.  Has received systemic therapy for the treatment of their stage IV NSCLC. Completion of treatment with chemotherapy and/or radiation as part of neoadjuvant/adjuvant therapy is allowed as long as therapy was completed at least 6 months prior to the diagnosis of metastatic disease.\n 3.  Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigation device within 4 weeks of the first dose of treatment.\n 4.  Is receiving systemic steroid therapy < 3 days prior to the first dose of trial treatment or receiving any other form of immunosuppressive medication.\n 5.  Is expected to require any other form of systemic or localized antineoplastic therapy while on trial (including maintenance therapy with another agent for NSCLC, radiation therapy, and/or surgical resection)\n 6.  Has received prior systemic cytotoxic chemotherapy, biological therapy, OR major surgery within 3 weeks of the first dose of trial treatment; received thoracic radiation therapy of > 30 Gy within 6 months of the first dose of trial treatment.\n 7.  Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).\n 8.  Has central nervous system (CNS) metastases and/or carcinomatous meningitis identified either on the baseline brain imaging obtained during the screening period OR identified prior to signing the ICF.\n 9.  Active autoimmune disease that has required systemic treatment in past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (i.e., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.\n 10. Has had an allogeneic tissue/solid organ transplant.\n 11. Has interstitial lung disease (ILD) OR has had a history of pneumonitis that has required oral or IV steroids.\n 12. Has received or will receive a live vaccine within 30 days prior to the first administration of study medication. Seasonal flu vaccines that do not contain a live virus are permitted\n 13. Has an active infection requiring intravenous systemic therapy.\n 14. Has known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).\n 15. Has known active Hepatitis B, Hepatitis C or tuberculosis.\n 16. Has clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke or myocardial infarction within 6 months of enrollment, unstable angina, congestive heart failure (New York Heart Association class â‰¥II), or serious uncontrolled cardiac arrhythmia requiring medication.\n 17. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating Investigator.\n 18. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n 19. Is, at the time of signing informed consent, a regular user (including \"recreational use\") of any illicit drugs or had a recent history (within the last year) of substance abuse (including alcohol).\n 20. Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit (Visit 1) through 120 days after the last dose of pembrolizumab or AGEN1884.","EGFR","epidermal growth factor receptor","Protein","Ovary, Breast, Lung","Actual","2018-01-26","Actual","Actual","2019-03-01","Actual","2019-11-01","2017-11-14","2018-01-19","2020-01-13","Yes",null,"Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No","Undecided",{"$nulls":3},"No","No",{"$nulls":19},"Occurrence of DLTs in subjects in the Safety Run-in Phase of the trial","Occurrence of DLTs in subjects in the Safety Run-in Phase of the trial","21 days","Frequency, severity, and duration of treatment-emergent AEs (TEAEs)|Frequency, severity, and duration of treatment-related AEs|Confirmed BOR per RECIST 1.1|Duration of response per RECIST 1.1|PFS time|OS time|Unconfirmed response at 12 weeks from first dose per RECIST 1.1|Pharmacokinetic profile of AGEN1884 and pembrolizumab|Immunogenicity of AGEN1884 and pembrolizumab","Frequency, severity, and duration of treatment-emergent AEs (TEAEs)|Frequency, severity, and duration of treatment-related AEs|Confirmed BOR per RECIST 1.1|Duration of response per RECIST 1.1|PFS time|OS time|Unconfirmed response at 12 weeks from first dose per RECIST 1.1|Pharmacokinetic profile of AGEN1884 and pembrolizumab|Immunogenicity of AGEN1884 and pembrolizumab","116 weeks|36 months|June 2020 ( When 14 patients have completed 2 years of treatment)|Up to 24 months from 1st dose of treatment|At least 20 patients have completed 12 weeks from 1st dose of treatment|All patients on study have completed 6 weeks from 1st dose of treatment",{"$nulls":3},"Brisbane, Australia Scientia Clinical ResearchSydney, Australia John Flynn Private HospitalTugun, Australia Sydney AdventistWahroonga, Australia|Auckland, New Zealand",null,"Australia|New Zealand","Mater Research|Auckland City Hospital",{"$nulls":3},"Waldo Ortuzar Feliu, MD","2020-01-13","2020-05-25T16:38:47.932","2020-05-26T17:10:42.972","NCT03411473"]
["5ecbf498307e3d1b1f8d9deb","NCT03411980","2018-03-07","Bayer","BAYN","Recruiting","Pharmacokinetics and Safety of Vilaprisan in Renal Impairment","Bay-1002670|Vilaprisan","PR Modulator","Yes","['Bay-1002670', 'Vilaprisan']","No",null,"Phase 1",3,26,"Anticipated","2018-02-02","2018-10-31","AUC","Area Under The Curve",{"$nulls":3},"The purpose of the study is to evaluate the pharmacokinetics of vilaprisan in subjects with moderate to severe renal impairment compared with matched subjects with normal renal function","This is a multiple-center, open-label, non-randomized, single-dose study in 3 parallel groups of subjects with moderately or severely impaired renal function or normal renal function matched with regard to sex, age, race and weight. PK blood and urine sampling for determination of vilaprisan concentrations in plasma and urine, respectively, will be preformed at pre-defined time points up to 14 days post-dose. Safety and tolerability will be assessed through adverse events, clinical laboratory tests, vital signs, 12-lead electrocardiograms and physical examinations","An Open-label, Single-dose Study to Evaluate the Pharmacokinetics and Safety of Vilaprisan in Subjects With Decreased Renal Function in Comparison With Matched Subjects With Normal Renal Function",16524,"Uterine Fibroids\nEndometriosis","Endometriosis","Female Urogenital","Reproductive and Urogenital","Experimental","Subjects with moderately decreased renal function|Subjects with severely decreased renal function|Control subjects with normal renal function","Subjects with moderate renal impairment with an estimated glomerular filtration rate (eGFR) of 30 to 59 mL/min/1.73 m*2 according to the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula.|Subjects with severe renal impairment not on dialysis with an eGFR <30 mL/min/1.73 m*2 (CKD-EPI formula).|Subjects with an eGFR â‰¥90 mL/min/1.73 m*2 (CKD-EPI formula) who are matched based on sex, age, race and weight.","Drug","Vilaprisan (BAY1002670)","Single oral dose (1 x 2 mg immediate-release, film-coated tablet)",null,"Subjects with moderately decreased renal function|Subjects with severely decreased renal function|Control subjects with normal renal function","\n\n * BMI: 18 to 40 kg/m*2 (inclusive)\n * Decreased renal function, as assessed at screening, based on serum creatinine and calculated according to the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula, either:\n\nModerately impaired renal function: eGFR: 30 to 59 mL/min/1.73 m*2; or Severely impaired renal function: eGFR <30 mL/min/1.73 m*2 but not on dialysis\n\n- Normal renal function, as assessed at screening and based on serum creatinine according to the CKD-EPI formula: eGFR â‰¥90 mL/min/1.73 m*2\n\n","\n\n * Any relevant disease within 4 weeks prior to study drug administration including infections and acute gastrointestinal diseases (vomiting, diarrhea, constipation) requiring medical treatment.\n * Severe cerebrovascular or cardiac disorders less than 6 months prior to study drug administration, e.g. stroke, myocardial infarction, unstable angina pectoris, percutaneous transluminal coronary angioplasty or coronary artery bypass graft, congestive heart failure of Grade III or IV according to New York Heart Association, or arrhythmia requiring antiarrhythmic treatment.\n * Malignancy diagnosed or treated within the past 5 years. This does not include adequately treated basal cell carcinoma or localized squamous cell carcinoma of the skin.\n * Acute renal failure or acute nephritis within the past 2 years.\n * Pregnancy or lactation.\n * Use of CYP3A4 inducers from 2 weeks before study drug administration until last day of blood sampling for PK after study drug administration, including grapefruits.\n * Insufficiently controlled diabetes mellitus with fasting blood glucose >220 mg/dL or HbA1c >10%.","EGFR","epidermal growth factor receptor","Protein","Ovary, Breast, Lung","Actual","2018-01-26","Actual","Anticipated","2018-11-28","Anticipated","2018-03-01","2018-01-22","2018-01-22","2018-03-06","No","Pharmacokinetics","Interventional","Other","Parallel Assignment","None (Open Label)","Non-Randomized","18 Years","79 Years","All",null,"Yes",{"$nulls":4},"Yes","No",{"$nulls":19},"Area under the concentration versus time curve from zero to infinity after single (first) dose (AUC) of BAY1002670|Maximum observed drug concentration in measured matrix after single dose administration (Cmax) of BAY1002670","Area under the concentration versus time curve from zero to the last data point above the lower limit of quantitation|In subjects with normal and moderately reduced renal function.","AUC(0-tlast), if AUC cannot be estimated in all subjects.\n\nIn subjects with normal and moderately reduced renal function.|-1h, 30min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h ,16h, 1d, 2d, 3d, 4d, 7d, 10d, 14d","Number of participants with adverse events|AUC|unbound AUC (AUCu)|Cmax|Unbound Cmax (Cmax,u)|Apparent oral clearance (CL/F)|Unbound CL/F (CLu/F)|Half-life associated with the terminal slope (t1/2)|Renal clearance (CLR)|Fraction of free (unbound) drug in plasma (fu)","In subjects with normal, moderately, and severely reduced renal function.","Up to 6 weeks|-1h, 30min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h ,16h, 1d, 2d, 3d, 4d, 7d, 10d, 14d",{"$nulls":3},"Miami, Florida, United States, 33014 Orlando Clinical Research CenterOrlando, Florida, United States, 32809","Florida","United States","Clinical Pharmacology Of Miami, Inc.",{"$nulls":4},"2018-03-06","2020-05-25T16:38:48.834","2020-05-26T17:10:42.972","NCT03411980"]
["5ecbf49811702c1b1b916b66","NCT03411980","2018-05-07","Bayer","BAYN","Recruiting","Pharmacokinetics and Safety of Vilaprisan in Renal Impairment","Bay-1002670|Vilaprisan","PR Modulator","Yes","['Bay-1002670', 'Vilaprisan']","No",null,"Phase 1",3,26,"Anticipated","2018-02-02","2018-10-31","AUC","Area Under The Curve",{"$nulls":3},"The purpose of the study is to evaluate the pharmacokinetics of vilaprisan in subjects with moderate to severe renal impairment compared with matched subjects with normal renal function","This is a multiple-center, open-label, non-randomized, single-dose study in 3 parallel groups of subjects with moderately or severely impaired renal function or normal renal function matched with regard to sex, age, race and weight. PK blood and urine sampling for determination of vilaprisan concentrations in plasma and urine, respectively, will be preformed at pre-defined time points up to 14 days post-dose. Safety and tolerability will be assessed through adverse events, clinical laboratory tests, vital signs, 12-lead electrocardiograms and physical examinations","An Open-label, Single-dose Study to Evaluate the Pharmacokinetics and Safety of Vilaprisan in Subjects With Decreased Renal Function in Comparison With Matched Subjects With Normal Renal Function",16524,"Uterine Fibroids\nEndometriosis","Endometriosis","Female Urogenital","Reproductive and Urogenital","Experimental","Subjects with moderately decreased renal function|Subjects with severely decreased renal function|Control subjects with normal renal function","Subjects with moderate renal impairment with an estimated glomerular filtration rate (eGFR) of 30 to 59 mL/min/1.73 m*2 according to the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula.|Subjects with severe renal impairment not on dialysis with an eGFR <30 mL/min/1.73 m*2 (CKD-EPI formula).|Subjects with an eGFR â‰¥90 mL/min/1.73 m*2 (CKD-EPI formula) who are matched based on sex, age, race and weight.","Drug","Vilaprisan (BAY1002670)","Single oral dose (1 x 2 mg immediate-release, film-coated tablet)",null,"Subjects with moderately decreased renal function|Subjects with severely decreased renal function|Control subjects with normal renal function","\n\n * BMI: 18 to 40 kg/m*2 (inclusive)\n * Decreased renal function, as assessed at screening, based on serum creatinine and calculated according to the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula, either:\n\nModerately impaired renal function: eGFR: 30 to 59 mL/min/1.73 m*2; or Severely impaired renal function: eGFR <30 mL/min/1.73 m*2 but not on dialysis\n\n- Normal renal function, as assessed at screening and based on serum creatinine according to the CKD-EPI formula: eGFR â‰¥90 mL/min/1.73 m*2\n\n","\n\n * Any relevant disease within 4 weeks prior to study drug administration including infections and acute gastrointestinal diseases (vomiting, diarrhea, constipation) requiring medical treatment.\n * Severe cerebrovascular or cardiac disorders less than 6 months prior to study drug administration, e.g. stroke, myocardial infarction, unstable angina pectoris, percutaneous transluminal coronary angioplasty or coronary artery bypass graft, congestive heart failure of Grade III or IV according to New York Heart Association, or arrhythmia requiring antiarrhythmic treatment.\n * Malignancy diagnosed or treated within the past 5 years. This does not include adequately treated basal cell carcinoma or localized squamous cell carcinoma of the skin.\n * Acute renal failure or acute nephritis within the past 2 years.\n * Pregnancy or lactation.\n * Use of CYP3A4 inducers from 2 weeks before study drug administration until last day of blood sampling for PK after study drug administration, including grapefruits.\n * Insufficiently controlled diabetes mellitus with fasting blood glucose >220 mg/dL or HbA1c >10%.","EGFR","epidermal growth factor receptor","Protein","Ovary, Breast, Lung","Actual","2018-01-26","Actual","Anticipated","2018-11-28","Anticipated","2018-05-01","2018-01-22","2018-01-22","2018-05-04","No","Pharmacokinetics","Interventional","Other","Parallel Assignment","None (Open Label)","Non-Randomized","18 Years","79 Years","All",null,"Yes",{"$nulls":4},"Yes","No",{"$nulls":19},"Area under the concentration versus time curve from zero to infinity after single (first) dose (AUC) of BAY1002670|Maximum observed drug concentration in measured matrix after single dose administration (Cmax) of BAY1002670","Area under the concentration versus time curve from zero to the last data point above the lower limit of quantitation|In subjects with normal and moderately reduced renal function.","AUC(0-tlast), if AUC cannot be estimated in all subjects.\n\nIn subjects with normal and moderately reduced renal function.|-1h, 30min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h ,16h, 1d, 2d, 3d, 4d, 7d, 10d, 14d","Number of participants with adverse events|AUC|unbound AUC (AUCu)|Cmax|Unbound Cmax (Cmax,u)|Apparent oral clearance (CL/F)|Unbound CL/F (CLu/F)|Half-life associated with the terminal slope (t1/2)|Renal clearance (CLR)|Fraction of free (unbound) drug in plasma (fu)","In subjects with normal, moderately, and severely reduced renal function.","Up to 6 weeks|-1h, 30min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h ,16h, 1d, 2d, 3d, 4d, 7d, 10d, 14d",{"$nulls":3},"Miami, Florida, United States, 33014 Orlando Clinical Research CenterOrlando, Florida, United States, 32809","Florida","United States","Clinical Pharmacology Of Miami, Inc.",{"$nulls":4},"2018-05-04","2020-05-25T16:38:48.384","2020-05-26T17:10:42.972","NCT03411980"]
["5ecbf498feab101b15530989","NCT03411980","2018-08-03","Bayer","BAYN","Recruiting","Pharmacokinetics and Safety of Vilaprisan in Renal Impairment","Bay-1002670|Vilaprisan","PR Modulator","Yes","['Bay-1002670', 'Vilaprisan']","No",null,"Phase 1",3,26,"Anticipated","2018-02-02","2018-10-31","AUC","Area Under The Curve",{"$nulls":3},"The purpose of the study is to evaluate the pharmacokinetics of vilaprisan in subjects with moderate to severe renal impairment compared with matched subjects with normal renal function","This is a multiple-center, open-label, non-randomized, single-dose study in 3 parallel groups of subjects with moderately or severely impaired renal function or normal renal function matched with regard to sex, age, race and weight. PK blood and urine sampling for determination of vilaprisan concentrations in plasma and urine, respectively, will be preformed at pre-defined time points up to 14 days post-dose. Safety and tolerability will be assessed through adverse events, clinical laboratory tests, vital signs, 12-lead electrocardiograms and physical examinations","An Open-label, Single-dose Study to Evaluate the Pharmacokinetics and Safety of Vilaprisan in Subjects With Decreased Renal Function in Comparison With Matched Subjects With Normal Renal Function",16524,"Uterine Fibroids\nEndometriosis","Endometriosis","Female Urogenital","Reproductive and Urogenital","Experimental","Subjects with moderately decreased renal function|Subjects with severely decreased renal function|Control subjects with normal renal function","Subjects with moderate renal impairment with an estimated glomerular filtration rate (eGFR) of 30 to 59 mL/min/1.73 m*2 according to the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula.|Subjects with severe renal impairment not on dialysis with an eGFR <30 mL/min/1.73 m*2 (CKD-EPI formula).|Subjects with an eGFR â‰¥90 mL/min/1.73 m*2 (CKD-EPI formula) who are matched based on sex, age, race and weight.","Drug","Vilaprisan (BAY1002670)","Single oral dose (1 x 2 mg immediate-release, film-coated tablet)",null,"Subjects with moderately decreased renal function|Subjects with severely decreased renal function|Control subjects with normal renal function","\n\n * BMI: 18 to 40 kg/m*2 (inclusive)\n * Decreased renal function, as assessed at screening, based on serum creatinine and calculated according to the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula, either:\n\nModerately impaired renal function: eGFR: 30 to 59 mL/min/1.73 m*2; or Severely impaired renal function: eGFR <30 mL/min/1.73 m*2 but not on dialysis\n\n- Normal renal function, as assessed at screening and based on serum creatinine according to the CKD-EPI formula: eGFR â‰¥90 mL/min/1.73 m*2\n\n","\n\n * Any relevant disease within 4 weeks prior to study drug administration including infections and acute gastrointestinal diseases (vomiting, diarrhea, constipation) requiring medical treatment.\n * Severe cerebrovascular or cardiac disorders less than 6 months prior to study drug administration, e.g. stroke, myocardial infarction, unstable angina pectoris, percutaneous transluminal coronary angioplasty or coronary artery bypass graft, congestive heart failure of Grade III or IV according to New York Heart Association, or arrhythmia requiring antiarrhythmic treatment.\n * Malignancy diagnosed or treated within the past 5 years. This does not include adequately treated basal cell carcinoma or localized squamous cell carcinoma of the skin.\n * Acute renal failure or acute nephritis within the past 2 years.\n * Pregnancy or lactation.\n * Use of CYP3A4 inducers from 2 weeks before study drug administration until last day of blood sampling for PK after study drug administration, including grapefruits.\n * Insufficiently controlled diabetes mellitus with fasting blood glucose >220 mg/dL or HbA1c >10%.","EGFR","epidermal growth factor receptor","Protein","Ovary, Breast, Lung","Actual","2018-01-26","Actual","Anticipated","2018-11-28","Anticipated","2018-08-01","2018-01-22","2018-01-22","2018-08-02","No","Pharmacokinetics","Interventional","Other","Parallel Assignment","None (Open Label)","Non-Randomized","18 Years","79 Years","All",null,"Yes",{"$nulls":4},"Yes","No",{"$nulls":19},"Area under the concentration versus time curve from zero to infinity after single (first) dose (AUC) of BAY1002670|Maximum observed drug concentration in measured matrix after single dose administration (Cmax) of BAY1002670","Area under the concentration versus time curve from zero to the last data point above the lower limit of quantitation|In subjects with normal and moderately reduced renal function.","AUC(0-tlast), if AUC cannot be estimated in all subjects.\n\nIn subjects with normal and moderately reduced renal function.|-1h, 30min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h ,16h, 1d, 2d, 3d, 4d, 7d, 10d, 14d","Number of participants with adverse events|AUC|unbound AUC (AUCu)|Cmax|Unbound Cmax (Cmax,u)|Apparent oral clearance (CL/F)|Unbound CL/F (CLu/F)|Half-life associated with the terminal slope (t1/2)|Renal clearance (CLR)|Fraction of free (unbound) drug in plasma (fu)","In subjects with normal, moderately, and severely reduced renal function.","Up to 6 weeks|-1h, 30min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h ,16h, 1d, 2d, 3d, 4d, 7d, 10d, 14d",{"$nulls":3},"Miami, Florida, United States, 33014 Orlando Clinical Research CenterOrlando, Florida, United States, 32809","Florida","United States","Clinical Pharmacology Of Miami, Inc.",{"$nulls":4},"2018-08-02","2020-05-25T16:38:48.909","2020-05-26T17:10:42.972","NCT03411980"]
["5ecbf499fe30261b1a04835c","NCT03411980","2018-09-28","Bayer","BAYN","Recruiting","Pharmacokinetics and Safety of Vilaprisan in Renal Impairment","Bay-1002670|Vilaprisan","PR Modulator","Yes","['Bay-1002670', 'Vilaprisan']","No",null,"Phase 1",3,26,"Anticipated","2018-02-02","2018-10-31","AUC","Area Under The Curve",{"$nulls":3},"The purpose of the study is to evaluate the pharmacokinetics of vilaprisan in subjects with moderate to severe renal impairment compared with matched subjects with normal renal function","This is a multiple-center, open-label, non-randomized, single-dose study in 3 parallel groups of subjects with moderately or severely impaired renal function or normal renal function matched with regard to sex, age, race and weight. PK blood and urine sampling for determination of vilaprisan concentrations in plasma and urine, respectively, will be preformed at pre-defined time points up to 14 days post-dose. Safety and tolerability will be assessed through adverse events, clinical laboratory tests, vital signs, 12-lead electrocardiograms and physical examinations","An Open-label, Single-dose Study to Evaluate the Pharmacokinetics and Safety of Vilaprisan in Subjects With Decreased Renal Function in Comparison With Matched Subjects With Normal Renal Function",16524,"Uterine Fibroids\nEndometriosis","Endometriosis","Female Urogenital","Reproductive and Urogenital","Experimental","Subjects with moderately decreased renal function|Subjects with severely decreased renal function|Control subjects with normal renal function","Subjects with moderate renal impairment with an estimated glomerular filtration rate (eGFR) of 30 to 59 mL/min/1.73 m*2 according to the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula.|Subjects with severe renal impairment not on dialysis with an eGFR <30 mL/min/1.73 m*2 (CKD-EPI formula).|Subjects with an eGFR â‰¥90 mL/min/1.73 m*2 (CKD-EPI formula) who are matched based on sex, age, race and weight.","Drug","Vilaprisan (BAY1002670)","Single oral dose (1 x 2 mg immediate-release, film-coated tablet)",null,"Subjects with moderately decreased renal function|Subjects with severely decreased renal function|Control subjects with normal renal function","\n\n * BMI: 18 to 40 kg/m*2 (inclusive)\n * Decreased renal function, as assessed at screening, based on serum creatinine and calculated according to the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula, either:\n\nModerately impaired renal function: eGFR: 30 to 59 mL/min/1.73 m*2; or Severely impaired renal function: eGFR <30 mL/min/1.73 m*2 but not on dialysis\n\n- Normal renal function, as assessed at screening and based on serum creatinine according to the CKD-EPI formula: eGFR â‰¥90 mL/min/1.73 m*2\n\n","\n\n * Any relevant disease within 4 weeks prior to study drug administration including infections and acute gastrointestinal diseases (vomiting, diarrhea, constipation) requiring medical treatment.\n * Severe cerebrovascular or cardiac disorders less than 6 months prior to study drug administration, e.g. stroke, myocardial infarction, unstable angina pectoris, percutaneous transluminal coronary angioplasty or coronary artery bypass graft, congestive heart failure of Grade III or IV according to New York Heart Association, or arrhythmia requiring antiarrhythmic treatment.\n * Malignancy diagnosed or treated within the past 5 years. This does not include adequately treated basal cell carcinoma or localized squamous cell carcinoma of the skin.\n * Acute renal failure or acute nephritis within the past 2 years.\n * Pregnancy or lactation.\n * Use of CYP3A4 inducers from 2 weeks before study drug administration until last day of blood sampling for PK after study drug administration, including grapefruits.\n * Insufficiently controlled diabetes mellitus with fasting blood glucose >220 mg/dL or HbA1c >10%.","EGFR","epidermal growth factor receptor","Protein","Ovary, Breast, Lung","Actual","2018-01-26","Actual","Anticipated","2018-11-28","Anticipated","2018-09-01","2018-01-22","2018-01-22","2018-09-27","No","Pharmacokinetics","Interventional","Other","Parallel Assignment","None (Open Label)","Non-Randomized","18 Years","79 Years","All",null,"Yes",{"$nulls":4},"Yes","No",{"$nulls":19},"Area under the concentration versus time curve from zero to infinity after single (first) dose (AUC) of BAY1002670|Maximum observed drug concentration in measured matrix after single dose administration (Cmax) of BAY1002670","Area under the concentration versus time curve from zero to the last data point above the lower limit of quantitation|In subjects with normal and moderately reduced renal function.","AUC(0-tlast), if AUC cannot be estimated in all subjects.\n\nIn subjects with normal and moderately reduced renal function.|-1h, 30min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h ,16h, 1d, 2d, 3d, 4d, 7d, 10d, 14d","Number of participants with adverse events|AUC|unbound AUC (AUCu)|Cmax|Unbound Cmax (Cmax,u)|Apparent oral clearance (CL/F)|Unbound CL/F (CLu/F)|Half-life associated with the terminal slope (t1/2)|Renal clearance (CLR)|Fraction of free (unbound) drug in plasma (fu)","In subjects with normal, moderately, and severely reduced renal function.","Up to 6 weeks|-1h, 30min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h ,16h, 1d, 2d, 3d, 4d, 7d, 10d, 14d",{"$nulls":3},"Miami, Florida, United States, 33014 Orlando Clinical Research CenterOrlando, Florida, United States, 32809","Florida","United States","Clinical Pharmacology Of Miami, Inc.",{"$nulls":4},"2018-09-27","2020-05-25T16:38:49.304","2020-05-26T17:10:42.972","NCT03411980"]
["5ecbf498307e3d1b1f8d9dec","NCT03411980","2018-10-30","Bayer","BAYN","Active, not recruiting","Pharmacokinetics and Safety of Vilaprisan in Renal Impairment","Bay-1002670|Vilaprisan","PR Modulator","Yes","['Bay-1002670', 'Vilaprisan']","No",null,"Phase 1",3,26,"Actual","2018-02-02","2018-10-10","AUC","Area Under The Curve",{"$nulls":3},"The purpose of the study is to evaluate the pharmacokinetics of vilaprisan in subjects with moderate to severe renal impairment compared with matched subjects with normal renal function","This is a multiple-center, open-label, non-randomized, single-dose study in 3 parallel groups of subjects with moderately or severely impaired renal function or normal renal function matched with regard to sex, age, race and weight. PK blood and urine sampling for determination of vilaprisan concentrations in plasma and urine, respectively, will be preformed at pre-defined time points up to 14 days post-dose. Safety and tolerability will be assessed through adverse events, clinical laboratory tests, vital signs, 12-lead electrocardiograms and physical examinations","An Open-label, Single-dose Study to Evaluate the Pharmacokinetics and Safety of Vilaprisan in Subjects With Decreased Renal Function in Comparison With Matched Subjects With Normal Renal Function",16524,"Uterine Fibroids\nEndometriosis","Endometriosis","Female Urogenital","Reproductive and Urogenital","Experimental","Subjects with moderately decreased renal function|Subjects with severely decreased renal function|Control subjects with normal renal function","Subjects with moderate renal impairment with an estimated glomerular filtration rate (eGFR) of 30 to 59 mL/min/1.73 m*2 according to the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula.|Subjects with severe renal impairment not on dialysis with an eGFR <30 mL/min/1.73 m*2 (CKD-EPI formula).|Subjects with an eGFR â‰¥90 mL/min/1.73 m*2 (CKD-EPI formula) who are matched based on sex, age, race and weight.","Drug","Vilaprisan (BAY1002670)","Single oral dose (1 x 2 mg immediate-release, film-coated tablet)",null,"Subjects with moderately decreased renal function|Subjects with severely decreased renal function|Control subjects with normal renal function","\n\n * BMI: 18 to 40 kg/m*2 (inclusive)\n * Decreased renal function, as assessed at screening, based on serum creatinine and calculated according to the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula, either:\n\nModerately impaired renal function: eGFR: 30 to 59 mL/min/1.73 m*2; or Severely impaired renal function: eGFR <30 mL/min/1.73 m*2 but not on dialysis\n\n- Normal renal function, as assessed at screening and based on serum creatinine according to the CKD-EPI formula: eGFR â‰¥90 mL/min/1.73 m*2\n\n","\n\n * Any relevant disease within 4 weeks prior to study drug administration including infections and acute gastrointestinal diseases (vomiting, diarrhea, constipation) requiring medical treatment.\n * Severe cerebrovascular or cardiac disorders less than 6 months prior to study drug administration, e.g. stroke, myocardial infarction, unstable angina pectoris, percutaneous transluminal coronary angioplasty or coronary artery bypass graft, congestive heart failure of Grade III or IV according to New York Heart Association, or arrhythmia requiring antiarrhythmic treatment.\n * Malignancy diagnosed or treated within the past 5 years. This does not include adequately treated basal cell carcinoma or localized squamous cell carcinoma of the skin.\n * Acute renal failure or acute nephritis within the past 2 years.\n * Pregnancy or lactation.\n * Use of CYP3A4 inducers from 2 weeks before study drug administration until last day of blood sampling for PK after study drug administration, including grapefruits.\n * Insufficiently controlled diabetes mellitus with fasting blood glucose >220 mg/dL or HbA1c >10%.","EGFR","epidermal growth factor receptor","Protein","Ovary, Breast, Lung","Actual","2018-01-26","Actual","Actual","2018-11-28","Anticipated","2018-10-01","2018-01-22","2018-01-22","2018-10-29","No","Pharmacokinetics","Interventional","Other","Parallel Assignment","None (Open Label)","Non-Randomized","18 Years","79 Years","All",null,"Yes",{"$nulls":4},"Yes","No",{"$nulls":19},"Area under the concentration versus time curve from zero to infinity after single (first) dose (AUC) of BAY1002670|Maximum observed drug concentration in measured matrix after single dose administration (Cmax) of BAY1002670","Area under the concentration versus time curve from zero to the last data point above the lower limit of quantitation|In subjects with normal and moderately reduced renal function.","AUC(0-tlast), if AUC cannot be estimated in all subjects.\n\nIn subjects with normal and moderately reduced renal function.|-1h, 30min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h ,16h, 1d, 2d, 3d, 4d, 7d, 10d, 14d","Number of participants with adverse events|AUC|unbound AUC (AUCu)|Cmax|Unbound Cmax (Cmax,u)|Apparent oral clearance (CL/F)|Unbound CL/F (CLu/F)|Half-life associated with the terminal slope (t1/2)|Renal clearance (CLR)|Fraction of free (unbound) drug in plasma (fu)","In subjects with normal, moderately, and severely reduced renal function.","Up to 6 weeks|-1h, 30min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h ,16h, 1d, 2d, 3d, 4d, 7d, 10d, 14d",{"$nulls":3},"Miami, Florida, United States, 33014 Orlando Clinical Research CenterOrlando, Florida, United States, 32809","Florida","United States","Clinical Pharmacology Of Miami, Inc.",{"$nulls":4},"2018-10-29","2020-05-25T16:38:48.972","2020-05-26T17:10:42.972","NCT03411980"]
["5ecbf499307e3d1b1f8d9ded","NCT03411980","2019-02-27","Bayer","BAYN","Completed","Pharmacokinetics and Safety of Vilaprisan in Renal Impairment","Bay-1002670|Vilaprisan","PR Modulator","Yes","['Bay-1002670', 'Vilaprisan']","No",null,"Phase 1",3,26,"Actual","2018-02-02","2018-10-10","AUC","Area Under The Curve",{"$nulls":3},"The purpose of the study is to evaluate the pharmacokinetics of vilaprisan in subjects with moderate to severe renal impairment compared with matched subjects with normal renal function.","This is a multiple-center, open-label, non-randomized, single-dose study in 3 parallel groups of subjects with moderately or severely impaired renal function or normal renal function matched with regard to sex, age, race and weight. PK blood and urine sampling for determination of vilaprisan concentrations in plasma and urine, respectively, will be preformed at pre-defined time points up to 14 days post-dose. Safety and tolerability will be assessed through adverse events, clinical laboratory tests, vital signs, 12-lead electrocardiograms and physical examinations.","An Open-label, Single-dose Study to Evaluate the Pharmacokinetics and Safety of Vilaprisan in Subjects With Decreased Renal Function in Comparison With Matched Subjects With Normal Renal Function",16524,"Uterine Fibroids\nEndometriosis","Endometriosis","Female Urogenital","Reproductive and Urogenital","Experimental","Subjects with moderately decreased renal function|Subjects with severely decreased renal function|Control subjects with normal renal function","Subjects with moderate renal impairment with an estimated glomerular filtration rate (eGFR) of 30 to 59 mL/min/1.73 m*2 according to the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula.|Subjects with severe renal impairment not on dialysis with an eGFR <30 mL/min/1.73 m*2 (CKD-EPI formula).|Subjects with an eGFR â‰¥90 mL/min/1.73 m*2 (CKD-EPI formula) who are matched based on sex, age, race and weight.","Drug","Vilaprisan (BAY1002670)","Single oral dose (1 x 2 mg immediate-release, film-coated tablet)",null,"Subjects with moderately decreased renal function|Subjects with severely decreased renal function|Control subjects with normal renal function","\n\n * BMI: 18 to 40 kg/m*2 (inclusive)\n * Decreased renal function, as assessed at screening, based on serum creatinine and calculated according to the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula, either:\n\nModerately impaired renal function: eGFR: 30 to 59 mL/min/1.73 m*2; or Severely impaired renal function: eGFR <30 mL/min/1.73 m*2 but not on dialysis\n\n- Normal renal function, as assessed at screening and based on serum creatinine according to the CKD-EPI formula: eGFR â‰¥90 mL/min/1.73 m*2\n\n","\n\n * Any relevant disease within 4 weeks prior to study drug administration including infections and acute gastrointestinal diseases (vomiting, diarrhea, constipation) requiring medical treatment.\n * Severe cerebrovascular or cardiac disorders less than 6 months prior to study drug administration, e.g. stroke, myocardial infarction, unstable angina pectoris, percutaneous transluminal coronary angioplasty or coronary artery bypass graft, congestive heart failure of Grade III or IV according to New York Heart Association, or arrhythmia requiring antiarrhythmic treatment.\n * Malignancy diagnosed or treated within the past 5 years. This does not include adequately treated basal cell carcinoma or localized squamous cell carcinoma of the skin.\n * Acute renal failure or acute nephritis within the past 2 years.\n * Pregnancy or lactation.\n * Use of CYP3A4 inducers from 2 weeks before study drug administration until last day of blood sampling for PK after study drug administration, including grapefruits.\n * Insufficiently controlled diabetes mellitus with fasting blood glucose >220 mg/dL or HbA1c >10%.","EGFR","epidermal growth factor receptor","Protein","Ovary, Breast, Lung","Actual","2018-01-26","Actual","Actual","2019-02-06","Actual","2019-02-01","2018-01-22","2018-01-22","2019-02-26","No","Pharmacokinetics","Interventional","Other","Parallel Assignment","None (Open Label)","Non-Randomized","18 Years","79 Years","All",null,"Yes",{"$nulls":4},"Yes","No",{"$nulls":19},"Area under the concentration versus time curve from zero to infinity after single (first) dose (AUC) of BAY1002670|Maximum observed drug concentration in measured matrix after single dose administration (Cmax) of BAY1002670","Area under the concentration versus time curve from zero to the last data point above the lower limit of quantitation|In subjects with normal and moderately reduced renal function.","AUC(0-tlast), if AUC cannot be estimated in all subjects.\n\nIn subjects with normal and moderately reduced renal function.|-1h, 30min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h ,16h, 1d, 2d, 3d, 4d, 7d, 10d, 14d","Number of participants with adverse events|AUC|unbound AUC (AUCu)|Cmax|Unbound Cmax (Cmax,u)|Apparent oral clearance (CL/F)|Unbound CL/F (CLu/F)|Half-life associated with the terminal slope (t1/2)|Renal clearance (CLR)|Fraction of free (unbound) drug in plasma (fu)","In subjects with normal, moderately, and severely reduced renal function.","Up to 6 weeks|-1h, 30min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h ,16h, 1d, 2d, 3d, 4d, 7d, 10d, 14d",{"$nulls":3},"Miami, Florida, United States, 33014 Orlando Clinical Research CenterOrlando, Florida, United States, 32809","Florida","United States","Clinical Pharmacology Of Miami, Inc.",{"$nulls":4},"2019-02-26","2020-05-25T16:38:49.520","2020-05-26T17:10:42.972","NCT03411980"]
["5ecbf499e2561b1b11905e56","NCT03412006","2018-01-26","Bayer","BAYN","Not yet recruiting","A Double-blind Study to Investigate Efficacy, Safety and Tolerability of BAY1142524 in Patients With Type II Diabetes and a Clinical Diagnosis of Diabetic Kidney Disease (CADA DIA)","Bay-1142524","Chymase Inhibitor","Yes","['Bay-1142524']","Yes","['Chymase Inhibitor']","Phase 2",2,107,"Anticipated","2018-02-01","2019-07-25",{"$nulls":5},"The purpose of the trial is the analysis of safety and efficacy of the chymase inhibitor BAY1142524 at a dose of 25 mg BID in comparison to placebo using a 6 months treatment period in type II diabetic patients with a clinical diagnosis of diabetic kidney disease. BAY1142524 or placebo will be given on top of evidence-based standard of care for diabetic kidney disease. Primary objective is the analysis of first signs of efficacy as determined by favourable changes in urinary albumin creatinine ratio. Secondary objective is the analysis of safety and tolerability as evidenced by the incidence and severity of adverse events. 64 valid patients have to complete treatment with verum and 32 valid patients have to complete treatment with placebo.",null,"A Randomized, Double-blind, Multicenter Study to Assess the Efficacy and Safety of a 6 Month Oral Treatment With the Chymase Inhibitor BAY 1142524 at a Dose of 25 mg BID in Comparison to Placebo on Top of Standard of Care in Patients With Type II Diabetes and a Clinical Diagnosis of Diabetic Kidney Disease",18933,"Diabetic Kidney Disease","Type 2 Diabetes|Type 1 Diabetes","Metabolic Diseases","Nutritional Disorders","Experimental|Placebo Comparator","BAY1142524|Placebo","Patients have to have a clinical diagnosis of diabetic kidney disease and have to be treated with standard of care for this condition","Drug","BAY1142524|Placebo","25 mg BAY1142524 are given twice daily over a treatment period of 6 months|Matching placebo tablets are given twice daily over a treatment period of 6 months",null,"BAY1142524|Placebo","\n\n * Patients with Type 2 Diabetes Mellitus and a clinical diagnosis of diabetic kidney disease (DKD) (as judged by the investigator) treated with at least the minimal recommended dose of an angiotensin receptor blocker (ARB) or an ACEI (angiotensin-converting enzyme inhibitor) (according to international or local guidelines) - but not with both simultaneously - for at least 3 months prior to the screening visit without any adjustments to this therapy for at least 4 weeks prior to the screening visit\n * UACR >50 mg/g and <3000 mg/g in 2 out of 3 consecutive morning void samples at the screening and the baseline visit\n * estimated glomerular filtration rate (eGFR) â‰¥30 mL/min/1.73 m*2 and <90 mL/min/1.73 m*2 (Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI]) at the screening visit and the baseline visit\n\n","\n\n * Non-DKD if it is the main diagnosis contributory to chronic kidney disease (CKD), as judged by the investigator\n * Known bilateral clinical relevant renal artery stenosis (>75%)\n * New York Heart Association (NYHA) Class IV\n * Acute kidney injury or dialysis within the last 3 months before the screening visit\n * Renal replacement therapy during study conduct\n * Renal allograft in place or a scheduled kidney transplant during study conduct\n * Stroke, transient ischemic cerebral attack, acute coronary syndrome, or hospitalization for heart failure in the last 3 months prior to screening visit\n * Clinically relevant hepatic dysfunction\n * Uncontrolled hypertension as evidenced by systolic blood pressure >180 mmHg, diastolic blood pressure >110 mmHg (mean of triplicate values at the screening or baseline visit)","EGFR","epidermal growth factor receptor","Protein","Ovary, Breast, Lung","Actual","2018-01-26","Actual","Anticipated","2019-08-15","Anticipated","2018-01-01","2018-01-22","2018-01-22","2018-01-22","Yes","type II diabetes\ndiabetic kidney disease","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years","79 Years","All",null,"No",{"$nulls":4},"No","No",{"$nulls":17},"2017-000656-26","EudraCT Number","Change in urinary albumin to creatinine ratio (UACR)","The ratio of albumin to creatinin will be determined in first morning void urine at baseline (before treatment start) and after 6 months of treatment","Baseline and at 6 months","Number of patients with treatment-emergent adverse event|Number of patients with serious adverse events","From first intake of study drug up to 3 days after last administration of study drug",{"$nulls":12},"2018-01-22","2020-05-25T16:38:49.649","2020-05-26T17:10:42.972","NCT03412006"]
["5ecbf499fe30261b1a04835d","NCT03412006","2018-04-18","Bayer","BAYN","Recruiting","A Double-blind Study to Investigate Efficacy, Safety and Tolerability of BAY1142524 in Patients With Type II Diabetes and a Clinical Diagnosis of Diabetic Kidney Disease (CADA DIA)","Bay-1142524","Chymase Inhibitor","Yes","['Bay-1142524']","Yes","['Chymase Inhibitor']","Phase 2",2,107,"Anticipated","2018-02-02","2019-07-25",{"$nulls":5},"The purpose of the trial is the analysis of safety and efficacy of the chymase inhibitor BAY1142524 at a dose of 25 mg BID in comparison to placebo using a 6 months treatment period in type II diabetic patients with a clinical diagnosis of diabetic kidney disease. BAY1142524 or placebo will be given on top of evidence-based standard of care for diabetic kidney disease. Primary objective is the analysis of first signs of efficacy as determined by favourable changes in urinary albumin creatinine ratio. Secondary objective is the analysis of safety and tolerability as evidenced by the incidence and severity of adverse events. 64 valid patients have to complete treatment with verum and 32 valid patients have to complete treatment with placebo.",null,"A Randomized, Double-blind, Multicenter Study to Assess the Efficacy and Safety of a 6 Month Oral Treatment With the Chymase Inhibitor BAY 1142524 at a Dose of 25 mg BID in Comparison to Placebo on Top of Standard of Care in Patients With Type II Diabetes and a Clinical Diagnosis of Diabetic Kidney Disease",18933,"Diabetic Kidney Disease","Type 2 Diabetes|Type 1 Diabetes","Metabolic Diseases","Nutritional Disorders","Experimental|Placebo Comparator","Fulacimstat (BAY1142524)|Placebo","Patients have to have a clinical diagnosis of diabetic kidney disease and have to be treated with standard of care for this condition","Drug","Fulacimstat (BAY1142524)|Placebo","25 mg BAY1142524 are given twice daily over a treatment period of 6 months|Matching placebo tablets are given twice daily over a treatment period of 6 months",null,"Fulacimstat (BAY1142524)|Placebo","\n\n * Patients with Type 2 Diabetes Mellitus and a clinical diagnosis of diabetic kidney disease (DKD) (as judged by the investigator) treated with at least the minimal recommended dose of an angiotensin receptor blocker (ARB) or an ACEI (angiotensin-converting enzyme inhibitor) (according to international or local guidelines) - but not with both simultaneously - for at least 3 months prior to the screening visit without any adjustments to this therapy for at least 4 weeks prior to the screening visit\n * UACR >50 mg/g and <3000 mg/g in 2 out of 3 consecutive morning void samples at the screening and the baseline visit\n * estimated glomerular filtration rate (eGFR) â‰¥30 mL/min/1.73 m*2 and <90 mL/min/1.73 m*2 (Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI]) at the screening visit and the baseline visit\n\n","\n\n * Non-DKD if it is the main diagnosis contributory to chronic kidney disease (CKD), as judged by the investigator\n * Known bilateral clinical relevant renal artery stenosis (>75%)\n * New York Heart Association (NYHA) Class IV\n * Acute kidney injury or dialysis within the last 3 months before the screening visit\n * Renal replacement therapy during study conduct\n * Renal allograft in place or a scheduled kidney transplant during study conduct\n * Stroke, transient ischemic cerebral attack, acute coronary syndrome, or hospitalization for heart failure in the last 3 months prior to screening visit\n * Clinically relevant hepatic dysfunction\n * Uncontrolled hypertension as evidenced by systolic blood pressure >180 mmHg, diastolic blood pressure >110 mmHg (mean of triplicate values at the screening or baseline visit)","EGFR","epidermal growth factor receptor","Protein","Ovary, Breast, Lung","Actual","2018-01-26","Actual","Anticipated","2019-08-15","Anticipated","2018-04-01","2018-01-22","2018-01-22","2018-04-16","Yes","type II diabetes\ndiabetic kidney disease","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years","79 Years","All",null,"No",{"$nulls":4},"No","No",{"$nulls":17},"2017-000656-26","EudraCT Number","Change in urinary albumin to creatinine ratio (UACR)","The ratio of albumin to creatinin will be determined in first morning void urine at baseline (before treatment start) and after 6 months of treatment","Baseline and at 6 months","Number of patients with treatment-emergent adverse event|Number of patients with serious adverse events","From first intake of study drug up to 3 days after last administration of study drug",{"$nulls":4},"Dimitrovgrad, Bulgaria, 6400 Mcomh Preventsia-2000Stara Zagora, Bulgaria, 6000 Med. Center EquitaVarna, Bulgaria, 9000|Copenhagen, Denmark, 2100 Steno Diabetes CenterGentofte, Denmark, 2820 NordsjÃ¦llands HospitalHillerÃ¸d, Denmark, 3400|Oulu, Finland, Fi-90100 Tays Tki Keskus TutkimusvastaanottoTampere, Finland, 33520 Turun Yliopistollinen Keskussairaala, KantasairaalaTurku, Finland, Fin-20520|Ashkelon, Israel, 7827804 Edith Wolfson Medical CenterHolon, Israel, 58100 Hadassah Hebrew University Hospital Ein KeremJerusalem, Israel, 9112001 Dmc - Diabetes Medical CenterTel Aviv, Israel, 6937947|Napoli, Campania, Italy, 80131|Foggia, Puglia, Italy, 71013|Padova, Veneto, Italy, 35128|Ferrol, A CoruÃ±a, Spain, 15405|Barcelona, Spain, 08025|Galdakao, Vizcaya, Spain, 48960|Kristianstad, Sweden, 29185 Akardo Medsite AbStockholm, Sweden, 114 46 S3 Clinical Research CentersVÃ¤llingby, Sweden, 162 68 Universitetssjukhuset Ã–rebroÃ–rebro, Sweden, 701 85",null,"Bulgaria|Denmark|Finland|Israel|Italy|Spain|Sweden","Med Centre Diamedical 2013|Rigshospitalet Copenhagen|Terveystalo Oulu|Barzilai Medical Center|Campania A.O.U. Policlinico Federico Ii Napoli|Puglia Irccs Casa Sollievo Della Sofferenza|Veneto A.O. Di Padova|A CoruÃ±a Complexo Hospitalario Universitario De Ferrol|Hospital FundaciÃ³ Puigvert|Vizcaya Hospital De Galdakao|Centralsjukhuset Kristianstad",{"$nulls":4},"2018-04-16","2020-05-25T16:38:49.858","2020-05-26T17:10:42.972","NCT03412006"]
["5ecbf499307e3d1b1f8d9dee","NCT03412006","2018-05-17","Bayer","BAYN","Recruiting","A Double-blind Study to Investigate Efficacy, Safety and Tolerability of BAY1142524 in Patients With Type II Diabetes and a Clinical Diagnosis of Diabetic Kidney Disease (CADA DIA)","Bay-1142524","Chymase Inhibitor","Yes","['Bay-1142524']","Yes","['Chymase Inhibitor']","Phase 2",2,107,"Anticipated","2018-02-02","2019-07-25",{"$nulls":5},"The purpose of the trial is the analysis of safety and efficacy of the chymase inhibitor BAY1142524 at a dose of 25 mg BID in comparison to placebo using a 6 months treatment period in type II diabetic patients with a clinical diagnosis of diabetic kidney disease. BAY1142524 or placebo will be given on top of evidence-based standard of care for diabetic kidney disease. Primary objective is the analysis of first signs of efficacy as determined by favourable changes in urinary albumin creatinine ratio. Secondary objective is the analysis of safety and tolerability as evidenced by the incidence and severity of adverse events. 64 valid patients have to complete treatment with verum and 32 valid patients have to complete treatment with placebo.",null,"A Randomized, Double-blind, Multicenter Study to Assess the Efficacy and Safety of a 6 Month Oral Treatment With the Chymase Inhibitor BAY 1142524 at a Dose of 25 mg BID in Comparison to Placebo on Top of Standard of Care in Patients With Type II Diabetes and a Clinical Diagnosis of Diabetic Kidney Disease",18933,"Diabetic Kidney Disease","Type 2 Diabetes|Type 1 Diabetes","Metabolic Diseases","Nutritional Disorders","Experimental|Placebo Comparator","Fulacimstat (BAY1142524)|Placebo","Patients have to have a clinical diagnosis of diabetic kidney disease and have to be treated with standard of care for this condition","Drug","Fulacimstat (BAY1142524)|Placebo","25 mg BAY1142524 are given twice daily over a treatment period of 6 months|Matching placebo tablets are given twice daily over a treatment period of 6 months",null,"Fulacimstat (BAY1142524)|Placebo","\n\n * Patients with Type 2 Diabetes Mellitus and a clinical diagnosis of diabetic kidney disease (DKD) (as judged by the investigator) treated with at least the minimal recommended dose of an angiotensin receptor blocker (ARB) or an ACEI (angiotensin-converting enzyme inhibitor) (according to international or local guidelines) - but not with both simultaneously - for at least 3 months prior to the screening visit without any adjustments to this therapy for at least 4 weeks prior to the screening visit\n * UACR >50 mg/g and <3000 mg/g in 2 out of 3 consecutive morning void samples at the screening and the baseline visit\n * estimated glomerular filtration rate (eGFR) â‰¥30 mL/min/1.73 m*2 and <90 mL/min/1.73 m*2 (Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI]) at the screening visit and the baseline visit\n\n","\n\n * Non-DKD if it is the main diagnosis contributory to chronic kidney disease (CKD), as judged by the investigator\n * Known bilateral clinical relevant renal artery stenosis (>75%)\n * New York Heart Association (NYHA) Class IV\n * Acute kidney injury or dialysis within the last 3 months before the screening visit\n * Renal replacement therapy during study conduct\n * Renal allograft in place or a scheduled kidney transplant during study conduct\n * Stroke, transient ischemic cerebral attack, acute coronary syndrome, or hospitalization for heart failure in the last 3 months prior to screening visit\n * Clinically relevant hepatic dysfunction\n * Uncontrolled hypertension as evidenced by systolic blood pressure >180 mmHg, diastolic blood pressure >110 mmHg (mean of triplicate values at the screening or baseline visit)","EGFR","epidermal growth factor receptor","Protein","Ovary, Breast, Lung","Actual","2018-01-26","Actual","Anticipated","2019-08-15","Anticipated","2018-05-01","2018-01-22","2018-01-22","2018-05-16","Yes","type II diabetes\ndiabetic kidney disease","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years","79 Years","All",null,"No",{"$nulls":4},"No","No",{"$nulls":17},"2017-000656-26","EudraCT Number","Change in urinary albumin to creatinine ratio (UACR)","The ratio of albumin to creatinin will be determined in first morning void urine at baseline (before treatment start) and after 6 months of treatment","Baseline and at 6 months","Number of patients with treatment-emergent adverse event|Number of patients with serious adverse events","From first intake of study drug up to 3 days after last administration of study drug",{"$nulls":4},"Dimitrovgrad, Bulgaria, 6400 Mcomh Preventsia-2000Stara Zagora, Bulgaria, 6000 Med. Center EquitaVarna, Bulgaria, 9000|Copenhagen, Denmark, 2100 Steno Diabetes CenterGentofte, Denmark, 2820 NordsjÃ¦llands HospitalHillerÃ¸d, Denmark, 3400|Oulu, Finland, Fi-90100 Tays Tki Keskus TutkimusvastaanottoTampere, Finland, 33520 Turun Yliopistollinen Keskussairaala, KantasairaalaTurku, Finland, Fin-20520|Ashkelon, Israel, 7827804 Edith Wolfson Medical CenterHolon, Israel, 58100 Hadassah Hebrew University Hospital Ein KeremJerusalem, Israel, 9112001 Dmc - Diabetes Medical CenterTel Aviv, Israel, 6937947|Napoli, Campania, Italy, 80131|Foggia, Puglia, Italy, 71013|Padova, Veneto, Italy, 35128|Ferrol, A CoruÃ±a, Spain, 15405|Barcelona, Spain, 08025|Galdakao, Vizcaya, Spain, 48960|Kristianstad, Sweden, 29185 Akardo Medsite AbStockholm, Sweden, 114 46 S3 Clinical Research CentersVÃ¤llingby, Sweden, 162 68 Universitetssjukhuset Ã–rebroÃ–rebro, Sweden, 701 85",null,"Bulgaria|Denmark|Finland|Israel|Italy|Spain|Sweden","Med Centre Diamedical 2013|Rigshospitalet Copenhagen|Terveystalo Oulu|Barzilai Medical Center|Campania A.O.U. Policlinico Federico Ii Napoli|Puglia Irccs Casa Sollievo Della Sofferenza|Veneto A.O. Di Padova|A CoruÃ±a Complexo Hospitalario Universitario De Ferrol|Hospital FundaciÃ³ Puigvert|Vizcaya Hospital De Galdakao|Centralsjukhuset Kristianstad",{"$nulls":4},"2018-05-16","2020-05-25T16:38:49.984","2020-05-26T17:10:42.972","NCT03412006"]
["5ecbf49ae2561b1b11905e57","NCT03412006","2018-09-05","Bayer","BAYN","Recruiting","A Double-blind Study to Investigate Efficacy, Safety and Tolerability of BAY1142524 in Patients With Type II Diabetes and a Clinical Diagnosis of Diabetic Kidney Disease (CADA DIA)","Bay-1142524","Chymase Inhibitor","Yes","['Bay-1142524']","Yes","['Chymase Inhibitor']","Phase 2",2,138,"Anticipated","2018-02-02","2019-07-25",{"$nulls":5},"The purpose of the trial is the analysis of safety and efficacy of the chymase inhibitor BAY1142524 at a dose of 25 mg BID in comparison to placebo using a 6 months treatment period in type II diabetic patients with a clinical diagnosis of diabetic kidney disease. BAY1142524 or placebo will be given on top of evidence-based standard of care for diabetic kidney disease. Primary objective is the analysis of first signs of efficacy as determined by favourable changes in urinary albumin creatinine ratio. Secondary objective is the analysis of safety and tolerability as evidenced by the incidence and severity of adverse events. 64 valid patients have to complete treatment with verum and 32 valid patients have to complete treatment with placebo.",null,"A Randomized, Double-blind, Multicenter Study to Assess the Efficacy and Safety of a 6 Month Oral Treatment With the Chymase Inhibitor BAY 1142524 at a Dose of 25 mg BID in Comparison to Placebo on Top of Standard of Care in Patients With Type II Diabetes and a Clinical Diagnosis of Diabetic Kidney Disease",18933,"Diabetic Kidney Disease","Type 2 Diabetes|Type 1 Diabetes","Metabolic Diseases","Nutritional Disorders","Experimental|Placebo Comparator","Fulacimstat (BAY1142524)|Placebo","Patients have to have a clinical diagnosis of diabetic kidney disease and have to be treated with standard of care for this condition","Drug","Fulacimstat (BAY1142524)|Placebo","25 mg BAY1142524 are given twice daily over a treatment period of 6 months|Matching placebo tablets are given twice daily over a treatment period of 6 months",null,"Fulacimstat (BAY1142524)|Placebo","\n\n * Patients with Type 2 Diabetes Mellitus and a clinical diagnosis of diabetic kidney disease (DKD) (as judged by the investigator) who have finished their up-titration with an angiotensin receptor blocker (ARB) or an ACEI (angiotensin-converting enzyme inhibitor) to their maximum tolerated dose at least 3 months prior to the screening visit, whereby the maximum tolerated dose has to be at least as high as the minimal recommended dose of an ARB or ACEI according to local and/or international guidelines. Patients have to be treated with an ARB or ACEI, but not with both simultaneously, without any adjustments to this therapy for at least 4 weeks prior to the screening visit.\n * UACR >50 mg/g and <3000 mg/g in 2 out of 3 consecutive morning void samples at the screening and the baseline visit\n * estimated glomerular filtration rate (eGFR) â‰¥30 mL/min/1.73 m*2 and <90 mL/min/1.73 m*2 (Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI]) at the screening visit and the baseline visit\n\n","\n\n * Non-DKD if it is the main diagnosis contributory to chronic kidney disease (CKD), as judged by the investigator\n * Known bilateral clinical relevant renal artery stenosis (>75%)\n * New York Heart Association (NYHA) Class IV\n * Acute kidney injury or dialysis within the last 3 months before the screening visit\n * Renal replacement therapy during study conduct\n * Renal allograft in place or a scheduled kidney transplant during study conduct\n * Stroke, transient ischemic cerebral attack, acute coronary syndrome, or hospitalization for heart failure in the last 3 months prior to screening visit\n * Clinically relevant hepatic dysfunction\n * Uncontrolled hypertension as evidenced by systolic blood pressure >160 mmHg, diastolic blood pressure >100 mmHg (mean of triplicate values at the screening or baseline visit)","EGFR","epidermal growth factor receptor","Protein","Ovary, Breast, Lung","Actual","2018-01-26","Actual","Anticipated","2019-08-15","Anticipated","2018-09-01","2018-01-22","2018-01-22","2018-09-04","Yes","type II diabetes\ndiabetic kidney disease","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years","79 Years","All",null,"No",{"$nulls":4},"No","No",{"$nulls":17},"2017-000656-26","EudraCT Number","Change in urinary albumin to creatinine ratio (UACR)","The ratio of albumin to creatinin will be determined in first morning void urine at baseline (before treatment start) and after 6 months of treatment","Baseline and at 6 months","Number of patients with treatment-emergent adverse event|Number of patients with serious adverse events","From first intake of study drug up to 3 days after last administration of study drug",{"$nulls":4},"Dimitrovgrad, Bulgaria, 6400 Mcomh Preventsia-2000Stara Zagora, Bulgaria, 6000 Med. Center EquitaVarna, Bulgaria, 9000|Copenhagen, Denmark, 2100 Steno Diabetes CenterGentofte, Denmark, 2820 NordsjÃ¦llands HospitalHillerÃ¸d, Denmark, 3400|Oulu, Finland, Fi-90100 Tays Tki Keskus TutkimusvastaanottoTampere, Finland, 33520 Turun Yliopistollinen Keskussairaala, KantasairaalaTurku, Finland, Fin-20520|Ashkelon, Israel, 7827804 Edith Wolfson Medical CenterHolon, Israel, 58100 Hadassah Hebrew University Hospital Ein KeremJerusalem, Israel, 9112001 The Nazareth Trust Hospital EmmsNazareth, Israel, 16100 Dmc - Diabetes Medical CenterTel Aviv, Israel, 6937947 Assaf Harofeh Medical CenterZerifin, Israel, 6093000|Napoli, Campania, Italy, 80131|Foggia, Puglia, Italy, 71013|Padova, Veneto, Italy, 35128|Ferrol, A CoruÃ±a, Spain, 15405|Barcelona, Spain, 08025|Galdakao, Vizcaya, Spain, 48960|Kristianstad, Sweden, 29185 Akardo Medsite AbStockholm, Sweden, 114 46 S3 Clinical Research CentersVÃ¤llingby, Sweden, 162 68 Universitetssjukhuset Ã–rebroÃ–rebro, Sweden, 701 85",null,"Bulgaria|Denmark|Finland|Israel|Italy|Spain|Sweden","Med Centre Diamedical 2013|Rigshospitalet Copenhagen|Terveystalo Oulu|Barzilai Medical Center|Campania A.O.U. Policlinico Federico Ii Napoli|Puglia Irccs Casa Sollievo Della Sofferenza|Veneto A.O. Di Padova|A CoruÃ±a Complexo Hospitalario Universitario De Ferrol|Hospital FundaciÃ³ Puigvert|Vizcaya Hospital De Galdakao|Centralsjukhuset Kristianstad",{"$nulls":4},"2018-09-04","2020-05-25T16:38:50.116","2020-05-26T17:10:42.972","NCT03412006"]
["5ecbf49afeab101b1553098d","NCT03412006","2018-09-28","Bayer","BAYN","Recruiting","A Double-blind Study to Investigate Efficacy, Safety and Tolerability of BAY1142524 in Patients With Type II Diabetes and a Clinical Diagnosis of Diabetic Kidney Disease (CADA DIA)","Bay-1142524","Chymase Inhibitor","Yes","['Bay-1142524']","Yes","['Chymase Inhibitor']","Phase 2",2,138,"Anticipated","2018-02-02","2019-07-25",{"$nulls":5},"The purpose of the trial is the analysis of safety and efficacy of the chymase inhibitor BAY1142524 at a dose of 25 mg BID in comparison to placebo using a 6 months treatment period in type II diabetic patients with a clinical diagnosis of diabetic kidney disease. BAY1142524 or placebo will be given on top of evidence-based standard of care for diabetic kidney disease. Primary objective is the analysis of first signs of efficacy as determined by favourable changes in urinary albumin creatinine ratio. Secondary objective is the analysis of safety and tolerability as evidenced by the incidence and severity of adverse events. 64 valid patients have to complete treatment with verum and 32 valid patients have to complete treatment with placebo.",null,"A Randomized, Double-blind, Multicenter Study to Assess the Efficacy and Safety of a 6 Month Oral Treatment With the Chymase Inhibitor BAY 1142524 at a Dose of 25 mg BID in Comparison to Placebo on Top of Standard of Care in Patients With Type II Diabetes and a Clinical Diagnosis of Diabetic Kidney Disease",18933,"Diabetic Kidney Disease","Type 2 Diabetes|Type 1 Diabetes","Metabolic Diseases","Nutritional Disorders","Experimental|Placebo Comparator","Fulacimstat (BAY1142524)|Placebo","Patients have to have a clinical diagnosis of diabetic kidney disease and have to be treated with standard of care for this condition","Drug","Fulacimstat (BAY1142524)|Placebo","25 mg BAY1142524 are given twice daily over a treatment period of 6 months|Matching placebo tablets are given twice daily over a treatment period of 6 months",null,"Fulacimstat (BAY1142524)|Placebo","\n\n * Patients with Type 2 Diabetes Mellitus and a clinical diagnosis of diabetic kidney disease (DKD) (as judged by the investigator) who have finished their up-titration with an angiotensin receptor blocker (ARB) or an ACEI (angiotensin-converting enzyme inhibitor) to their maximum tolerated dose at least 3 months prior to the screening visit, whereby the maximum tolerated dose has to be at least as high as the minimal recommended dose of an ARB or ACEI according to local and/or international guidelines. Patients have to be treated with an ARB or ACEI, but not with both simultaneously, without any adjustments to this therapy for at least 4 weeks prior to the screening visit.\n * UACR >50 mg/g and <3000 mg/g in 2 out of 3 consecutive morning void samples at the screening and the baseline visit\n * estimated glomerular filtration rate (eGFR) â‰¥30 mL/min/1.73 m*2 and <90 mL/min/1.73 m*2 (Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI]) at the screening visit and the baseline visit\n\n","\n\n * Non-DKD if it is the main diagnosis contributory to chronic kidney disease (CKD), as judged by the investigator\n * Known bilateral clinical relevant renal artery stenosis (>75%)\n * New York Heart Association (NYHA) Class IV\n * Acute kidney injury or dialysis within the last 3 months before the screening visit\n * Renal replacement therapy during study conduct\n * Renal allograft in place or a scheduled kidney transplant during study conduct\n * Stroke, transient ischemic cerebral attack, acute coronary syndrome, or hospitalization for heart failure in the last 3 months prior to screening visit\n * Clinically relevant hepatic dysfunction\n * Uncontrolled hypertension as evidenced by systolic blood pressure >160 mmHg, diastolic blood pressure >100 mmHg (mean of triplicate values at the screening or baseline visit)","EGFR","epidermal growth factor receptor","Protein","Ovary, Breast, Lung","Actual","2018-01-26","Actual","Anticipated","2019-08-15","Anticipated","2018-09-01","2018-01-22","2018-01-22","2018-09-27","Yes","type II diabetes\ndiabetic kidney disease","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years","79 Years","All",null,"No",{"$nulls":4},"No","No",{"$nulls":17},"2017-000656-26","EudraCT Number","Change in urinary albumin to creatinine ratio (UACR)","The ratio of albumin to creatinin will be determined in first morning void urine at baseline (before treatment start) and after 6 months of treatment","Baseline and at 6 months","Number of patients with treatment-emergent adverse event|Number of patients with serious adverse events","From first intake of study drug up to 3 days after last administration of study drug",{"$nulls":4},"Dimitrovgrad, Bulgaria, 6400 Mcomh Preventsia-2000Stara Zagora, Bulgaria, 6000 Med. Center EquitaVarna, Bulgaria, 9000|Copenhagen, Denmark, 2100 Steno Diabetes CenterGentofte, Denmark, 2820 NordsjÃ¦llands HospitalHillerÃ¸d, Denmark, 3400|Oulu, Finland, Fi-90100 Tays Tki Keskus TutkimusvastaanottoTampere, Finland, 33520 Turun Yliopistollinen Keskussairaala, KantasairaalaTurku, Finland, Fin-20520|Ashkelon, Israel, 7827804 Edith Wolfson Medical CenterHolon, Israel, 58100 Hadassah Hebrew University Hospital Ein KeremJerusalem, Israel, 9112001 The Nazareth Trust Hospital EmmsNazareth, Israel, 16100 Dmc - Diabetes Medical CenterTel Aviv, Israel, 6937947 Assaf Harofeh Medical CenterZerifin, Israel, 6093000|Napoli, Campania, Italy, 80131|Foggia, Puglia, Italy, 71013|Padova, Veneto, Italy, 35128|Ferrol, A CoruÃ±a, Spain, 15405|Barcelona, Spain, 08025|Galdakao, Vizcaya, Spain, 48960|Kristianstad, Sweden, 29185 Akardo Medsite AbStockholm, Sweden, 114 46 S3 Clinical Research CentersVÃ¤llingby, Sweden, 162 68 Universitetssjukhuset Ã–rebroÃ–rebro, Sweden, 701 85",null,"Bulgaria|Denmark|Finland|Israel|Italy|Spain|Sweden","Med Centre Diamedical 2013|Rigshospitalet Copenhagen|Terveystalo Oulu|Barzilai Medical Center|Campania A.O.U. Policlinico Federico Ii Napoli|Puglia Irccs Casa Sollievo Della Sofferenza|Veneto A.O. Di Padova|A CoruÃ±a Complexo Hospitalario Universitario De Ferrol|Hospital FundaciÃ³ Puigvert|Vizcaya Hospital De Galdakao|Centralsjukhuset Kristianstad",{"$nulls":4},"2018-09-27","2020-05-25T16:38:50.253","2020-05-26T17:10:42.972","NCT03412006"]
["5ecbf49a11702c1b1b916b6b","NCT03412006","2018-12-03","Bayer","BAYN","Recruiting","A Double-blind Study to Investigate Efficacy, Safety and Tolerability of BAY1142524 in Patients With Type II Diabetes and a Clinical Diagnosis of Diabetic Kidney Disease (CADA DIA)","Bay-1142524","Chymase Inhibitor","Yes","['Bay-1142524']","Yes","['Chymase Inhibitor']","Phase 2",2,138,"Anticipated","2018-02-02","2019-09-10",{"$nulls":5},"The purpose of the trial is the analysis of safety and efficacy of the chymase inhibitor BAY1142524 at a dose of 25 mg BID in comparison to placebo using a 6 months treatment period in type II diabetic patients with a clinical diagnosis of diabetic kidney disease. BAY1142524 or placebo will be given on top of evidence-based standard of care for diabetic kidney disease. Primary objective is the analysis of first signs of efficacy as determined by favourable changes in urinary albumin creatinine ratio. Secondary objective is the analysis of safety and tolerability as evidenced by the incidence and severity of adverse events. 64 valid patients have to complete treatment with verum and 32 valid patients have to complete treatment with placebo.",null,"A Randomized, Double-blind, Multicenter Study to Assess the Efficacy and Safety of a 6 Month Oral Treatment With the Chymase Inhibitor BAY 1142524 at a Dose of 25 mg BID in Comparison to Placebo on Top of Standard of Care in Patients With Type II Diabetes and a Clinical Diagnosis of Diabetic Kidney Disease",18933,"Diabetic Kidney Disease","Type 2 Diabetes|Type 1 Diabetes","Metabolic Diseases","Nutritional Disorders","Experimental|Placebo Comparator","Fulacimstat (BAY1142524)|Placebo","Patients have to have a clinical diagnosis of diabetic kidney disease and have to be treated with standard of care for this condition","Drug","Fulacimstat (BAY1142524)|Placebo","25 mg BAY1142524 are given twice daily over a treatment period of 6 months|Matching placebo tablets are given twice daily over a treatment period of 6 months",null,"Fulacimstat (BAY1142524)|Placebo","\n\n * Patients with Type 2 Diabetes Mellitus and a clinical diagnosis of diabetic kidney disease (DKD) (as judged by the investigator) who have finished their up-titration with an angiotensin receptor blocker (ARB) or an ACEI (angiotensin-converting enzyme inhibitor) to their maximum tolerated dose at least 3 months prior to the screening visit, whereby the maximum tolerated dose has to be at least as high as the minimal recommended dose of an ARB or ACEI according to local and/or international guidelines. Patients have to be treated with an ARB or ACEI, but not with both simultaneously, without any adjustments to this therapy for at least 4 weeks prior to the screening visit.\n * UACR >50 mg/g and <3000 mg/g in 2 out of 3 consecutive morning void samples at the screening and the baseline visit\n * estimated glomerular filtration rate (eGFR) â‰¥30 mL/min/1.73 m*2 and <90 mL/min/1.73 m*2 (Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI]) at the screening visit and the baseline visit\n\n","\n\n * Non-DKD if it is the main diagnosis contributory to chronic kidney disease (CKD), as judged by the investigator\n * Known bilateral clinical relevant renal artery stenosis (>75%)\n * New York Heart Association (NYHA) Class IV\n * Acute kidney injury or dialysis within the last 3 months before the screening visit\n * Renal replacement therapy during study conduct\n * Renal allograft in place or a scheduled kidney transplant during study conduct\n * Stroke, transient ischemic cerebral attack, acute coronary syndrome, or hospitalization for heart failure in the last 3 months prior to screening visit\n * Clinically relevant hepatic dysfunction\n * Uncontrolled hypertension as evidenced by systolic blood pressure >160 mmHg, diastolic blood pressure >100 mmHg (mean of triplicate values at the screening or baseline visit)","EGFR","epidermal growth factor receptor","Protein","Ovary, Breast, Lung","Actual","2018-01-26","Actual","Anticipated","2019-09-23","Anticipated","2018-11-01","2018-01-22","2018-01-22","2018-11-30","Yes","type II diabetes\ndiabetic kidney disease","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years","79 Years","All",null,"No",{"$nulls":4},"No","No",{"$nulls":17},"2017-000656-26","EudraCT Number","Change in urinary albumin to creatinine ratio (UACR)","The ratio of albumin to creatinin will be determined in first morning void urine at baseline (before treatment start) and after 6 months of treatment","Baseline and at 6 months","Number of patients with treatment-emergent adverse event|Number of patients with serious adverse events","From first intake of study drug up to 3 days after last administration of study drug",{"$nulls":4},"Dimitrovgrad, Bulgaria, 6400 Mcomh Preventsia-2000Stara Zagora, Bulgaria, 6000 Med. Center EquitaVarna, Bulgaria, 9000|Copenhagen, Denmark, 2100 Steno Diabetes CenterGentofte, Denmark, 2820 NordsjÃ¦llands HospitalHillerÃ¸d, Denmark, 3400|Oulu, Finland, Fi-90100 Tays Tki Keskus TutkimusvastaanottoTampere, Finland, 33520 Turun Yliopistollinen Keskussairaala, KantasairaalaTurku, Finland, Fin-20520|Ashkelon, Israel, 7827804 Edith Wolfson Medical CenterHolon, Israel, 58100 Hadassah Hebrew University Hospital Ein KeremJerusalem, Israel, 9112001 The Nazareth Trust Hospital EmmsNazareth, Israel, 16100 Dmc - Diabetes Medical CenterTel Aviv, Israel, 6937947 Assaf Harofeh Medical CenterZerifin, Israel, 6093000|Napoli, Campania, Italy, 80131|Foggia, Puglia, Italy, 71013|Padova, Veneto, Italy, 35128|Ferrol, A CoruÃ±a, Spain, 15405|Barcelona, Spain, 08025|Galdakao, Vizcaya, Spain, 48960|Kristianstad, Sweden, 29185 Akardo Medsite AbStockholm, Sweden, 114 46 S3 Clinical Research CentersVÃ¤llingby, Sweden, 162 68 Universitetssjukhuset Ã–rebroÃ–rebro, Sweden, 701 85",null,"Bulgaria|Denmark|Finland|Israel|Italy|Spain|Sweden","Med Centre Diamedical 2013|Rigshospitalet Copenhagen|Terveystalo Oulu|Barzilai Medical Center|Campania A.O.U. Policlinico Federico Ii Napoli|Puglia Irccs Casa Sollievo Della Sofferenza|Veneto A.O. Di Padova|A CoruÃ±a Complexo Hospitalario Universitario De Ferrol|Hospital FundaciÃ³ Puigvert|Vizcaya Hospital De Galdakao|Centralsjukhuset Kristianstad",{"$nulls":4},"2018-11-30","2020-05-25T16:38:50.461","2020-05-26T17:10:42.972","NCT03412006"]
["5ecbf49afe30261b1a04835f","NCT03412006","2019-02-20","Bayer","BAYN","Recruiting","A Double-blind Study to Investigate Efficacy, Safety and Tolerability of BAY1142524 in Patients With Type II Diabetes and a Clinical Diagnosis of Diabetic Kidney Disease (CADA DIA)","Bay-1142524","Chymase Inhibitor","Yes","['Bay-1142524']","Yes","['Chymase Inhibitor']","Phase 2",2,138,"Anticipated","2018-02-02","2019-09-11",{"$nulls":5},"The purpose of the trial is the analysis of safety and efficacy of the chymase inhibitor BAY1142524 at a dose of 25 mg BID in comparison to placebo using a 6 months treatment period in type II diabetic patients with a clinical diagnosis of diabetic kidney disease. BAY1142524 or placebo will be given on top of evidence-based standard of care for diabetic kidney disease. Primary objective is the analysis of first signs of efficacy as determined by favourable changes in urinary albumin creatinine ratio. Secondary objective is the analysis of safety and tolerability as evidenced by the incidence and severity of adverse events. 64 valid patients have to complete treatment with verum and 32 valid patients have to complete treatment with placebo.",null,"A Randomized, Double-blind, Multicenter Study to Assess the Efficacy and Safety of a 6 Month Oral Treatment With the Chymase Inhibitor BAY 1142524 at a Dose of 25 mg BID in Comparison to Placebo on Top of Standard of Care in Patients With Type II Diabetes and a Clinical Diagnosis of Diabetic Kidney Disease",18933,"Diabetic Kidney Disease","Type 2 Diabetes|Type 1 Diabetes","Metabolic Diseases","Nutritional Disorders","Experimental|Placebo Comparator","Fulacimstat (BAY1142524)|Placebo","Patients have to have a clinical diagnosis of diabetic kidney disease and have to be treated with standard of care for this condition","Drug","Fulacimstat (BAY1142524)|Placebo","25 mg BAY1142524 are given twice daily over a treatment period of 6 months|Matching placebo tablets are given twice daily over a treatment period of 6 months",null,"Fulacimstat (BAY1142524)|Placebo","\n\n * Patients with Type 2 Diabetes Mellitus and a clinical diagnosis of diabetic kidney disease (DKD) (as judged by the investigator) who have finished their up-titration with an angiotensin receptor blocker (ARB) or an ACEI (angiotensin-converting enzyme inhibitor) to their maximum tolerated dose at least 3 months prior to the screening visit, whereby the maximum tolerated dose has to be at least as high as the minimal recommended dose of an ARB or ACEI according to local and/or international guidelines. Patients have to be treated with an ARB or ACEI, but not with both simultaneously, without any adjustments to this therapy for at least 4 weeks prior to the screening visit.\n * UACR >50 mg/g and <3000 mg/g in 2 out of 3 consecutive morning void samples at the screening and the baseline visit\n * estimated glomerular filtration rate (eGFR) â‰¥30 mL/min/1.73 m*2 and <90 mL/min/1.73 m*2 (Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI]) at the screening visit and the baseline visit\n\n","\n\n * Non-DKD if it is the main diagnosis contributory to chronic kidney disease (CKD), as judged by the investigator\n * Known bilateral clinical relevant renal artery stenosis (>75%)\n * New York Heart Association (NYHA) Class IV\n * Acute kidney injury or dialysis within the last 3 months before the screening visit\n * Renal replacement therapy during study conduct\n * Renal allograft in place or a scheduled kidney transplant during study conduct\n * Stroke, transient ischemic cerebral attack, acute coronary syndrome, or hospitalization for heart failure in the last 3 months prior to screening visit\n * Clinically relevant hepatic dysfunction\n * Uncontrolled hypertension as evidenced by systolic blood pressure >160 mmHg, diastolic blood pressure >100 mmHg (mean of triplicate values at the screening or baseline visit)","EGFR","epidermal growth factor receptor","Protein","Ovary, Breast, Lung","Actual","2018-01-26","Actual","Anticipated","2019-09-23","Anticipated","2019-02-01","2018-01-22","2018-01-22","2019-02-19","Yes","type II diabetes\ndiabetic kidney disease","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years","79 Years","All",null,"No",{"$nulls":4},"No","No",{"$nulls":17},"2017-000656-26","EudraCT Number","Change in urinary albumin to creatinine ratio (UACR)","The ratio of albumin to creatinin will be determined in first morning void urine at baseline (before treatment start) and after 6 months of treatment","Baseline and at 6 months","Number of patients with treatment-emergent adverse event|Number of patients with serious adverse events","From first intake of study drug up to 3 days after last administration of study drug",null,"clinical-trials-contact@bayer.com","Bayer Clinical Trials Contact","(+) 1-888-8422937","Dimitrovgrad, Bulgaria, 6400 Mcomh Preventsia-2000Stara Zagora, Bulgaria, 6000 Med. Center EquitaVarna, Bulgaria, 9000|Copenhagen, Denmark, 2100 Steno Diabetes CenterGentofte, Denmark, 2820 NordsjÃ¦llands HospitalHillerÃ¸d, Denmark, 3400|Kuopio, Finland, 70100 Terveystalo OuluOulu, Finland, Fi-90100 Tays Tki Keskus TutkimusvastaanottoTampere, Finland, 33520 Turun Yliopistollinen Keskussairaala, KantasairaalaTurku, Finland, Fin-20520|Ashkelon, Israel, 7827804 Edith Wolfson Medical CenterHolon, Israel, 58100 Hadassah Hebrew University Hospital Ein KeremJerusalem, Israel, 9112001 The Nazareth Trust Hospital EmmsNazareth, Israel, 16100 Dmc - Diabetes Medical CenterTel Aviv, Israel, 6937947 Assaf Harofeh Medical CenterZerifin, Israel, 6093000|Napoli, Campania, Italy, 80131 Asl Napoli 1 Centro - CampaniaNapoli, Campania, Italy, 80138|Bologna, Emilia-Romagna, Italy, 40138|Foggia, Puglia, Italy, 71013|Padova, Veneto, Italy, 35128|Ferrol, A CoruÃ±a, Spain, 15405|Barcelona, Spain, 08025|Galdakao, Vizcaya, Spain, 48960|Kristianstad, Sweden, 29185 Akardo Medsite AbStockholm, Sweden, 114 46 S3 Clinical Research CentersVÃ¤llingby, Sweden, 162 68 Universitetssjukhuset Ã–rebroÃ–rebro, Sweden, 701 85",null,"Bulgaria|Denmark|Finland|Israel|Italy|Spain|Sweden","Med Centre Diamedical 2013|Rigshospitalet Copenhagen|Pihlajalinna Ite Kuopio|Barzilai Medical Center|Campania A.O.U. Policlinico Federico Ii Napoli|Emilia-Romagna Univ. Alma Mater - Dip. Medicina Spec, Diagnostica E Sperim|Puglia Irccs Casa Sollievo Della Sofferenza|Veneto A.O. Di Padova|A CoruÃ±a Complexo Hospitalario Universitario De Ferrol|Hospital FundaciÃ³ Puigvert|Vizcaya Hospital De Galdakao|Centralsjukhuset Kristianstad",{"$nulls":4},"2019-02-19","2020-05-25T16:38:50.462","2020-05-26T17:10:42.972","NCT03412006"]
["5ecbf49a11702c1b1b916b6c","NCT03412006","2019-05-17","Bayer","BAYN","Active, not recruiting","A Double-blind Study to Investigate Efficacy, Safety and Tolerability of BAY1142524 in Patients With Type II Diabetes and a Clinical Diagnosis of Diabetic Kidney Disease (CADA DIA)","Bay-1142524","Chymase Inhibitor","Yes","['Bay-1142524']","Yes","['Chymase Inhibitor']","Phase 2",2,147,"Actual","2018-02-02","2019-10-10",{"$nulls":5},"The purpose of the trial is the analysis of safety and efficacy of the chymase inhibitor BAY1142524 at a dose of 25 mg BID in comparison to placebo using a 6 months treatment period in type II diabetic patients with a clinical diagnosis of diabetic kidney disease. BAY1142524 or placebo will be given on top of evidence-based standard of care for diabetic kidney disease. Primary objective is the analysis of first signs of efficacy as determined by favourable changes in urinary albumin creatinine ratio. Secondary objective is the analysis of safety and tolerability as evidenced by the incidence and severity of adverse events. 64 valid patients have to complete treatment with verum and 32 valid patients have to complete treatment with placebo.",null,"A Randomized, Double-blind, Multicenter Study to Assess the Efficacy and Safety of a 6 Month Oral Treatment With the Chymase Inhibitor BAY 1142524 at a Dose of 25 mg BID in Comparison to Placebo on Top of Standard of Care in Patients With Type II Diabetes and a Clinical Diagnosis of Diabetic Kidney Disease",18933,"Diabetic Kidney Disease","Type 2 Diabetes|Type 1 Diabetes","Metabolic Diseases","Nutritional Disorders","Experimental|Placebo Comparator","Fulacimstat (BAY1142524)|Placebo","Patients have to have a clinical diagnosis of diabetic kidney disease and have to be treated with standard of care for this condition","Drug","Fulacimstat (BAY1142524)|Placebo","25 mg BAY1142524 are given twice daily over a treatment period of 6 months|Matching placebo tablets are given twice daily over a treatment period of 6 months",null,"Fulacimstat (BAY1142524)|Placebo","\n\n * Patients with Type 2 Diabetes Mellitus and a clinical diagnosis of diabetic kidney disease (DKD) (as judged by the investigator) who have finished their up-titration with an angiotensin receptor blocker (ARB) or an ACEI (angiotensin-converting enzyme inhibitor) to their maximum tolerated dose at least 3 months prior to the screening visit, whereby the maximum tolerated dose has to be at least as high as the minimal recommended dose of an ARB or ACEI according to local and/or international guidelines. Patients have to be treated with an ARB or ACEI, but not with both simultaneously, without any adjustments to this therapy for at least 4 weeks prior to the screening visit.\n * UACR >50 mg/g and <3000 mg/g in 2 out of 3 consecutive morning void samples at the screening and the baseline visit\n * estimated glomerular filtration rate (eGFR) â‰¥30 mL/min/1.73 m*2 and <90 mL/min/1.73 m*2 (Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI]) at the screening visit and the baseline visit\n\n","\n\n * Non-DKD if it is the main diagnosis contributory to chronic kidney disease (CKD), as judged by the investigator\n * Known bilateral clinical relevant renal artery stenosis (>75%)\n * New York Heart Association (NYHA) Class IV\n * Acute kidney injury or dialysis within the last 3 months before the screening visit\n * Renal replacement therapy during study conduct\n * Renal allograft in place or a scheduled kidney transplant during study conduct\n * Stroke, transient ischemic cerebral attack, acute coronary syndrome, or hospitalization for heart failure in the last 3 months prior to screening visit\n * Clinically relevant hepatic dysfunction\n * Uncontrolled hypertension as evidenced by systolic blood pressure >160 mmHg, diastolic blood pressure >100 mmHg (mean of triplicate values at the screening or baseline visit)","EGFR","epidermal growth factor receptor","Protein","Ovary, Breast, Lung","Actual","2018-01-26","Actual","Anticipated","2019-10-17","Anticipated","2019-05-01","2018-01-22","2018-01-22","2019-05-16","Yes","type II diabetes\ndiabetic kidney disease","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years","79 Years","All",null,"No",{"$nulls":4},"No","No",{"$nulls":17},"2017-000656-26","EudraCT Number","Change in urinary albumin to creatinine ratio (UACR)","The ratio of albumin to creatinin will be determined in first morning void urine at baseline (before treatment start) and after 6 months of treatment","Baseline and at 6 months","Number of patients with treatment-emergent adverse event|Number of patients with serious adverse events","From first intake of study drug up to 3 days after last administration of study drug",{"$nulls":4},"Dimitrovgrad, Bulgaria, 6400 Mcomh Preventsia-2000Stara Zagora, Bulgaria, 6000 Med. Center EquitaVarna, Bulgaria, 9000|Copenhagen, Denmark, 2100 Steno Diabetes CenterGentofte, Denmark, 2820 NordsjÃ¦llands HospitalHillerÃ¸d, Denmark, 3400|Kuopio, Finland, 70100 Terveystalo OuluOulu, Finland, Fi-90100 Tays Tki Keskus TutkimusvastaanottoTampere, Finland, 33520 Turun Yliopistollinen Keskussairaala, KantasairaalaTurku, Finland, Fin-20520|Ashkelon, Israel, 7827804 Edith Wolfson Medical CenterHolon, Israel, 58100 Hadassah Hebrew University Hospital Ein KeremJerusalem, Israel, 9112001 The Nazareth Trust Hospital EmmsNazareth, Israel, 16100 Dmc - Diabetes Medical CenterTel Aviv, Israel, 6937947 Assaf Harofeh Medical CenterZerifin, Israel, 6093000|Napoli, Campania, Italy, 80131|Bologna, Emilia-Romagna, Italy, 40138|Foggia, Puglia, Italy, 71013|Padova, Veneto, Italy, 35128|Ferrol, A CoruÃ±a, Spain, 15405|Barcelona, Spain, 08025|Galdakao, Vizcaya, Spain, 48960|Kristianstad, Sweden, 29185 Akardo Medsite AbStockholm, Sweden, 114 46 S3 Clinical Research CentersVÃ¤llingby, Sweden, 162 68 Universitetssjukhuset Ã–rebroÃ–rebro, Sweden, 701 85",null,"Bulgaria|Denmark|Finland|Israel|Italy|Spain|Sweden","Med Centre Diamedical 2013|Rigshospitalet Copenhagen|Pihlajalinna Ite Kuopio|Barzilai Medical Center|Campania A.O.U. Policlinico Federico Ii Napoli|Emilia-Romagna Univ. Alma Mater - Dip. Medicina Spec, Diagnostica E Sperim|Puglia Irccs Casa Sollievo Della Sofferenza|Veneto A.O. Di Padova|A CoruÃ±a Complexo Hospitalario Universitario De Ferrol|Hospital FundaciÃ³ Puigvert|Vizcaya Hospital De Galdakao|Centralsjukhuset Kristianstad",{"$nulls":4},"2019-05-16","2020-05-25T16:38:50.893","2020-05-26T17:10:42.972","NCT03412006"]
["5ecbf49be2561b1b11905e5a","NCT03412006","2019-07-11","Bayer","BAYN","Active, not recruiting","A Double-blind Study to Investigate Efficacy, Safety and Tolerability of BAY1142524 in Patients With Type II Diabetes and a Clinical Diagnosis of Diabetic Kidney Disease (CADA DIA)","Bay-1142524","Chymase Inhibitor","Yes","['Bay-1142524']","Yes","['Chymase Inhibitor']","Phase 2",2,147,"Actual","2018-02-02","2019-10-10",{"$nulls":5},"The purpose of the trial is the analysis of safety and efficacy of the chymase inhibitor BAY1142524 at a dose of 25 mg BID in comparison to placebo using a 6 months treatment period in type II diabetic patients with a clinical diagnosis of diabetic kidney disease. BAY1142524 or placebo will be given on top of evidence-based standard of care for diabetic kidney disease. Primary objective is the analysis of first signs of efficacy as determined by favourable changes in urinary albumin creatinine ratio. Secondary objective is the analysis of safety and tolerability as evidenced by the incidence and severity of adverse events. 64 valid patients have to complete treatment with verum and 32 valid patients have to complete treatment with placebo.",null,"A Randomized, Double-blind, Multicenter Study to Assess the Efficacy and Safety of a 6 Month Oral Treatment With the Chymase Inhibitor BAY 1142524 at a Dose of 25 mg BID in Comparison to Placebo on Top of Standard of Care in Patients With Type II Diabetes and a Clinical Diagnosis of Diabetic Kidney Disease",18933,"Diabetic Kidney Disease","Type 2 Diabetes|Type 1 Diabetes","Metabolic Diseases","Nutritional Disorders","Experimental|Placebo Comparator","Fulacimstat (BAY1142524)|Placebo","Patients have to have a clinical diagnosis of diabetic kidney disease and have to be treated with standard of care for this condition","Drug","Fulacimstat (BAY1142524)|Placebo","25 mg BAY1142524 are given twice daily over a treatment period of 6 months|Matching placebo tablets are given twice daily over a treatment period of 6 months",null,"Fulacimstat (BAY1142524)|Placebo","\n\n * Patients with Type 2 Diabetes Mellitus and a clinical diagnosis of diabetic kidney disease (DKD) (as judged by the investigator) who have finished their up-titration with an angiotensin receptor blocker (ARB) or an ACEI (angiotensin-converting enzyme inhibitor) to their maximum tolerated dose at least 3 months prior to the screening visit, whereby the maximum tolerated dose has to be at least as high as the minimal recommended dose of an ARB or ACEI according to local and/or international guidelines. Patients have to be treated with an ARB or ACEI, but not with both simultaneously, without any adjustments to this therapy for at least 4 weeks prior to the screening visit.\n * UACR >50 mg/g and <3000 mg/g in 2 out of 3 consecutive morning void samples at the screening and the baseline visit\n * estimated glomerular filtration rate (eGFR) â‰¥30 mL/min/1.73 m*2 and <90 mL/min/1.73 m*2 (Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI]) at the screening visit and the baseline visit\n\n","\n\n * Non-DKD if it is the main diagnosis contributory to chronic kidney disease (CKD), as judged by the investigator\n * Known bilateral clinical relevant renal artery stenosis (>75%)\n * New York Heart Association (NYHA) Class IV\n * Acute kidney injury or dialysis within the last 3 months before the screening visit\n * Renal replacement therapy during study conduct\n * Renal allograft in place or a scheduled kidney transplant during study conduct\n * Stroke, transient ischemic cerebral attack, acute coronary syndrome, or hospitalization for heart failure in the last 3 months prior to screening visit\n * Clinically relevant hepatic dysfunction\n * Uncontrolled hypertension as evidenced by systolic blood pressure >160 mmHg, diastolic blood pressure >100 mmHg (mean of triplicate values at the screening or baseline visit)","EGFR","epidermal growth factor receptor","Protein","Ovary, Breast, Lung","Actual","2018-01-26","Actual","Anticipated","2019-10-17","Anticipated","2019-07-01","2018-01-22","2018-01-22","2019-07-10","Yes","type II diabetes\ndiabetic kidney disease","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years","79 Years","All",null,"No",{"$nulls":4},"No","No",{"$nulls":17},"2017-000656-26","EudraCT Number","Change in urinary albumin to creatinine ratio (UACR)","The ratio of albumin to creatinin will be determined in first morning void urine at baseline (before treatment start) and after 6 months of treatment","Baseline and at 6 months","Number of patients with treatment-emergent adverse event|Number of patients with serious adverse events","From first intake of study drug up to 3 days after last administration of study drug",{"$nulls":4},"Dimitrovgrad, Bulgaria, 6400 Mcomh Preventsia-2000Stara Zagora, Bulgaria, 6000 Med. Center EquitaVarna, Bulgaria, 9000|Copenhagen, Denmark, 2100 Steno Diabetes CenterGentofte, Denmark, 2820 NordsjÃ¦llands HospitalHillerÃ¸d, Denmark, 3400|Kuopio, Finland, 70100 Terveystalo OuluOulu, Finland, Fi-90100 Tays Tki Keskus TutkimusvastaanottoTampere, Finland, 33520 Turun Yliopistollinen Keskussairaala, KantasairaalaTurku, Finland, Fin-20520|Ashkelon, Israel, 7827804 Edith Wolfson Medical CenterHolon, Israel, 58100 Hadassah Hebrew University Hospital Ein KeremJerusalem, Israel, 9112001 The Nazareth Trust Hospital EmmsNazareth, Israel, 16100 Dmc - Diabetes Medical CenterTel Aviv, Israel, 6937947 Assaf Harofeh Medical CenterZerifin, Israel, 6093000|Napoli, Campania, Italy, 80131|Bologna, Emilia-Romagna, Italy, 40138|Foggia, Puglia, Italy, 71013|Padova, Veneto, Italy, 35128|Ferrol, A CoruÃ±a, Spain, 15405|Barcelona, Spain, 08025|Galdakao, Vizcaya, Spain, 48960|Kristianstad, Sweden, 29185 Akardo Medsite AbStockholm, Sweden, 114 46 S3 Clinical Research CentersVÃ¤llingby, Sweden, 162 68 Universitetssjukhuset Ã–rebroÃ–rebro, Sweden, 701 85",null,"Bulgaria|Denmark|Finland|Israel|Italy|Spain|Sweden","Med Centre Diamedical 2013|Rigshospitalet Copenhagen|Pihlajalinna Ite Kuopio|Barzilai Medical Center|Campania A.O.U. Policlinico Federico Ii Napoli|Emilia-Romagna Univ. Alma Mater - Dip. Medicina Spec, Diagnostica E Sperim|Puglia Irccs Casa Sollievo Della Sofferenza|Veneto A.O. Di Padova|A CoruÃ±a Complexo Hospitalario Universitario De Ferrol|Hospital FundaciÃ³ Puigvert|Vizcaya Hospital De Galdakao|Centralsjukhuset Kristianstad",{"$nulls":4},"2019-07-10","2020-05-25T16:38:51.278","2020-05-26T17:10:42.972","NCT03412006"]
["5ecbf49b307e3d1b1f8d9df2","NCT03412006","2019-10-03","Bayer","BAYN","Active, not recruiting","A Double-blind Study to Investigate Efficacy, Safety and Tolerability of BAY1142524 in Patients With Type II Diabetes and a Clinical Diagnosis of Diabetic Kidney Disease (CADA DIA)","Bay-1142524","Chymase Inhibitor","Yes","['Bay-1142524']","Yes","['Chymase Inhibitor']","Phase 2",2,147,"Actual","2018-02-02","2019-10-10",{"$nulls":5},"The purpose of the trial is the analysis of safety and efficacy of the chymase inhibitor BAY1142524 at a dose of 25 mg BID in comparison to placebo using a 6 months treatment period in type II diabetic patients with a clinical diagnosis of diabetic kidney disease. BAY1142524 or placebo will be given on top of evidence-based standard of care for diabetic kidney disease. Primary objective is the analysis of first signs of efficacy as determined by favourable changes in urinary albumin creatinine ratio. Secondary objective is the analysis of safety and tolerability as evidenced by the incidence and severity of adverse events. 64 valid patients have to complete treatment with verum and 32 valid patients have to complete treatment with placebo.",null,"A Randomized, Double-blind, Multicenter Study to Assess the Efficacy and Safety of a 6 Month Oral Treatment With the Chymase Inhibitor BAY 1142524 at a Dose of 25 mg BID in Comparison to Placebo on Top of Standard of Care in Patients With Type II Diabetes and a Clinical Diagnosis of Diabetic Kidney Disease",18933,"Diabetic Kidney Disease","Type 2 Diabetes|Type 1 Diabetes","Metabolic Diseases","Nutritional Disorders","Experimental|Placebo Comparator","Fulacimstat (BAY1142524)|Placebo","Patients have to have a clinical diagnosis of diabetic kidney disease and have to be treated with standard of care for this condition","Drug","Fulacimstat (BAY1142524)|Placebo","25 mg BAY1142524 are given twice daily over a treatment period of 6 months|Matching placebo tablets are given twice daily over a treatment period of 6 months",null,"Fulacimstat (BAY1142524)|Placebo","\n\n * Patients with Type 2 Diabetes Mellitus and a clinical diagnosis of diabetic kidney disease (DKD) (as judged by the investigator) who have finished their up-titration with an angiotensin receptor blocker (ARB) or an ACEI (angiotensin-converting enzyme inhibitor) to their maximum tolerated dose at least 3 months prior to the screening visit, whereby the maximum tolerated dose has to be at least as high as the minimal recommended dose of an ARB or ACEI according to local and/or international guidelines. Patients have to be treated with an ARB or ACEI, but not with both simultaneously, without any adjustments to this therapy for at least 4 weeks prior to the screening visit.\n * UACR >50 mg/g and <3000 mg/g in 2 out of 3 consecutive morning void samples at the screening and the baseline visit\n * estimated glomerular filtration rate (eGFR) â‰¥30 mL/min/1.73 m*2 and <90 mL/min/1.73 m*2 (Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI]) at the screening visit and the baseline visit\n\n","\n\n * Non-DKD if it is the main diagnosis contributory to chronic kidney disease (CKD), as judged by the investigator\n * Known bilateral clinical relevant renal artery stenosis (>75%)\n * New York Heart Association (NYHA) Class IV\n * Acute kidney injury or dialysis within the last 3 months before the screening visit\n * Renal replacement therapy during study conduct\n * Renal allograft in place or a scheduled kidney transplant during study conduct\n * Stroke, transient ischemic cerebral attack, acute coronary syndrome, or hospitalization for heart failure in the last 3 months prior to screening visit\n * Clinically relevant hepatic dysfunction\n * Uncontrolled hypertension as evidenced by systolic blood pressure >160 mmHg, diastolic blood pressure >100 mmHg (mean of triplicate values at the screening or baseline visit)","EGFR","epidermal growth factor receptor","Protein","Ovary, Breast, Lung","Actual","2018-01-26","Actual","Anticipated","2019-10-17","Anticipated","2019-10-01","2018-01-22","2018-01-22","2019-10-02","Yes","type II diabetes\ndiabetic kidney disease","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years","79 Years","All",null,"No",{"$nulls":4},"No","No",{"$nulls":17},"2017-000656-26","EudraCT Number","Change in urinary albumin to creatinine ratio (UACR)","The ratio of albumin to creatinin will be determined in first morning void urine at baseline (before treatment start) and after 6 months of treatment","Baseline and at 6 months","Number of patients with treatment-emergent adverse event|Number of patients with serious adverse events","From first intake of study drug up to 3 days after last administration of study drug",{"$nulls":4},"Dimitrovgrad, Bulgaria, 6400 Mcomh Preventsia-2000Stara Zagora, Bulgaria, 6000 Med. Center EquitaVarna, Bulgaria, 9000|Copenhagen, Denmark, 2100 Steno Diabetes CenterGentofte, Denmark, 2820 NordsjÃ¦llands HospitalHillerÃ¸d, Denmark, 3400|Kuopio, Finland, 70100 Terveystalo OuluOulu, Finland, Fi-90100 Tays Tki Keskus TutkimusvastaanottoTampere, Finland, 33520 Turun Yliopistollinen Keskussairaala, KantasairaalaTurku, Finland, Fin-20520|Ashkelon, Israel, 7827804 Edith Wolfson Medical CenterHolon, Israel, 58100 Hadassah Hebrew University Hospital Ein KeremJerusalem, Israel, 9112001 The Nazareth Trust Hospital EmmsNazareth, Israel, 16100 Dmc - Diabetes Medical CenterTel Aviv, Israel, 6937947 The Shamir Medical Center (Assaf Harofeh)Zerifin, Israel, 6093000|Napoli, Campania, Italy, 80131|Bologna, Emilia-Romagna, Italy, 40138|Foggia, Puglia, Italy, 71013|Padova, Veneto, Italy, 35128|Ferrol, A CoruÃ±a, Spain, 15405|Barcelona, Spain, 08025|Galdakao, Vizcaya, Spain, 48960|Kristianstad, Sweden, 29185 Akardo Medsite AbStockholm, Sweden, 114 46 S3 Clinical Research CentersVÃ¤llingby, Sweden, 162 68 Universitetssjukhuset Ã–rebroÃ–rebro, Sweden, 701 85",null,"Bulgaria|Denmark|Finland|Israel|Italy|Spain|Sweden","Med Centre Diamedical 2013|Rigshospitalet Copenhagen|Pihlajalinna Ite Kuopio|Barzilai Medical Center|Campania A.O.U. Policlinico Federico Ii Napoli|Emilia-Romagna Univ. Alma Mater - Dip. Medicina Spec, Diagnostica E Sperim|Puglia Irccs Casa Sollievo Della Sofferenza|Veneto A.O. Di Padova|A CoruÃ±a Complexo Hospitalario Universitario De Ferrol|Hospital FundaciÃ³ Puigvert|Vizcaya Hospital De Galdakao|Centralsjukhuset Kristianstad",{"$nulls":4},"2019-10-02","2020-05-25T16:38:51.281","2020-05-26T17:10:42.972","NCT03412006"]
["5ecbf49c11702c1b1b916b6f","NCT03412565","2018-01-26","Johnson & Johnson","JNJ","Not yet recruiting","A Study to Evaluate Subcutaneous Daratumumab in Combination With Standard Multiple Myeloma Treatment Regimens","Daratumumab|Bortezomib|Lenalidomide|Dexamethasone|Melphalan|Prednisone","CD38 Inhibitor|Proteasome Inhibitor|Angiogenesis Inhibitor|GR Agonist|GR Agonist|Immunosuppressive","No",null,"No",null,"Phase 2",3,180,"Anticipated","2018-07-23","2019-09-27","RR","Response Rate",{"$nulls":3},"The purpose of this study is to evaluate the clinical benefit of subcutaneous (SC) daratumumab administered in combination with standard multiple myeloma (MM) regimens in participants with MM as measured by overall response rate (ORR) or very good partial response (VGPR) or better rate.","The hypothesis is that the addition of daratumumab administered SC to standard MM regimens will improve responses compared to response data observed in completed phase 3 studies without daratumumab. Disease evaluations will include measurements of myeloma proteins, bone marrow examinations, skeletal surveys, assessment of extramedullary plasmacytomas, and measurements of serum calcium corrected for albumin. Safety will be measured by adverse events, laboratory test results, electrocardiogram (ECGs), vital sign measurements, physical examination findings, SC injection-site assessments, and assessment of Eastern Cooperative Oncology Group (ECOG) performance status score. Study will consist of 3 phases (screening, treatment and follow-up) and duration of study is approximately 3 years.","A Multicenter Phase 2 Study to Evaluate Subcutaneous Daratumumab in Combination With Standard Multiple Myeloma Treatment Regimens","CR108435","Multiple Myeloma","Multiple Myeloma","Oncology Hematological","Oncology","Experimental","Daratumumab(D)+Bortezomib+Lenalidomide+Dexamethasone (D-VRd)|D + Bortezomib + Melphalan + Prednisone + Dexamethasone(D-VMP)|Daratumumab + Lenalidomide + Dexamethasone (D-Rd)","Participants will receive daratumumab 1800 milligram (mg) by subcutaneous (SC) injection on Days 1, 8 and 15 of Cycles 1 to 3 (each cycle of 21 days) and on Day 1 of Cycle 4; bortezomib 1.3 milligram per square meter (mg/m^2) SC injection on Days 1, 4, 8 and 11 of Cycles 1 to 4; lenalidomide 25 mg orally on Day 1 through Day 14 of Cycles 1 to 4 and dexamethasone 20 mg orally or intravenously on Days 1, 2 ,8, 9, 15 and 16 of Cycle 1 to 4.|Participants will receive daratumumab 1800 mg by SC injection on Days 1, 8, 15, 22, 29 and 36 of Cycle 1 (each cycle of 42 days) then on Days 1 and 22 in Cycles 2 to 9 and Day 1 of Cycle 10 (each cycle of 28 days) and thereafter until documented progression of disease, unacceptable toxicity, or end of study; bortezomib 1.3 mg/m^2 SC injection on Day 1, 4, 8, 11, 22, 25, 29 and 32 of Cycles 1 and on Days 1, 8, 22 and 29 of Cycles 2 to 9; melphalan 9 mg/m^2 orally on Day 1 through Day 4 of Cycles 1 to 9; prednisone 60 mg/m^2 orally on Days 2, 3 and 4 of cycles 1 to 9 and dexamethasone 20 mg orally on Days 1, 8, 15, 22, 29 and 36 of Cycle 1 and on Days 1 and 22 of Cycles 2 to 9 and and on Day 1 of Cycle 10 and thereafter until documented progression of disease, unacceptable toxicity, or end of study.|Participants will receive daratumumab 1800 mg by SC injection on Days 1, 8, 15 and 22 of Cycles 1 and 2 (each cycle of 28 days) then on Day 1 and 15 of Cycles 3 to 6 and on Day 1 of Cycle 7 and thereafter until documented progression of disease, unacceptable toxicity, or end of study; lenalidomide 25 mg orally on Day 1 through Day 21 in Cycles 1 to 7 and thereafter until documented progression of disease, unacceptable toxicity, or end of study and dexamethasone 40 mg orally or intravenously on Days 1, 8, 15 and 22 of Cycle 1 to 7 and thereafter until documented progression of disease, unacceptable toxicity, or end of study.","Drug","Daratumumab|Bortezomib|Lenalidomide|Dexamethasone|Melphalan|Prednisone","Daratumumab will be administered at a dose of 1800 mg by SC injection in Cycles 1 to 4 in D-VRd reporting group, in Cycles 1 to 10 and thereafter until documented progression of disease, unacceptable toxicity, or end of study in D-VMP reporting group and in Cycles 1 to 7 and thereafter until documented progression of disease, unacceptable toxicity, or end of study in D-Rd reporting group.|Bortezomib will be administered as 1.3 mg/m^2 SC injection in Cycles 1 to 4 in D-VRd reporting group and in Cycles 1 to 9 in D-VMP reporting group.|Lenalidomide will be administered as 25 mg capsule orally in Cycles 1 to 4 in D-VRd reporting group and in Cycles 1 to 7 and thereafter until documented progression of disease, unacceptable toxicity, or end of study in D-Rd reporting group.|Dexamethasone will be administered as 20 mg orally or intravenously in Cycles 1 to 4 in D-VRd reporting group; 20 mg orally in cycles 1 to 10 and thereafter until documented progression of disease, unacceptable toxicity, or end of study in D-VMP reporting group and 40 mg orally or intravenously in Cycles 1 to 7 and thereafter until documented progression of disease, unacceptable toxicity, or end of study in D-Rd reporting group.|Melphalan will be administered as 9 mg/m^2 orally in Cycles 1 to 9.|Prednisone will be administered as 60 mg/m^2 orally in cycles 1 to 9.",null,"Daratumumab(D)+Bortezomib+Lenalidomide+Dexamethasone (D-VRd)|D + Bortezomib + Melphalan + Prednisone + Dexamethasone(D-VMP)|Daratumumab + Lenalidomide + Dexamethasone (D-Rd)","\n\n * Multiple myeloma diagnosed according to the International Myeloma Working Group (IMWG) diagnostic criteria\n * Measurable, secretory disease as defined by any of the following: 1. Serum monoclonal paraprotein (M-protein) level greater than or equal to (>=) 1.0 gram per deciliter (g/dL); or\n    2. Urine M-protein level >= 200 milligram per 24 hours (mg/24 hours); or\n    3. Light chain multiple myeloma (MM), for participants without measurable disease in the serum or urine: serum Immunoglobulin (Ig) free light chain (FLC) >= 10 mg/dL and abnormal FLC ratio\n   \n   \n * Meets one of the sets of the following criteria: 1. For Daratumumab + bortezomib + lenalidomide + dexamethasone (D-VRd) and Daratumumab + bortezomib + melphalan + prednisone + dexamethasone (D-VMP) regimen: newly diagnosed myeloma\n    2. For Daratumumab + lenalidomide + dexamethasone (D-Rd) regimen: relapsed or refractory disease\n   \n   \n * Eastern Cooperative Oncology Group (ECOG) Performance Status grade of 0, 1, or 2\n * During the study, and for 3 months after receiving the last dose of daratumumab, a woman must agree not to donate eggs (ova, oocytes) and men must agree not to donate sperm for the purposes of assisted reproduction\n\n","\n\n * History of malignancy (other than MM) if all treatment of that malignancy was completed at least 2 years before registration and the participant has no evidence of disease (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or breast, or other non-invasive lesion, that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence within 3 years)\n * Exhibits clinical signs of meningeal involvement of MM\n * Either of the following: 1. Chronic obstructive pulmonary disease with a forced expiratory volume in 1 second (FEV1) is less than (<) 50 % of predicted normal\n    2. Moderate or severe persistent asthma, or a history of asthma within the last 2 years, or currently has uncontrolled asthma of any classification\n   \n   \n * Any of the following: 1. Seropositive for human immunodeficiency virus;\n    2. Hepatitis B (hepatitis B surface antigen [HBsAg] positive, or antibodies to hepatitis B surface or core antigens [antiHBs or antiHBc] with hepatitis B virus [HBV]- Deoxyribonucleic acid [DNA] quantitation positive). Participants who are positive for antiHBs or antiHBc must have a negative polymerase chain reaction (PCR) for HBV-DNA quantitation result at screening. Those who are polymerase chain reaction (PCR) positive will be excluded\n   \n   \n * Seropositive for hepatitis C (except in the setting of a sustained virologic response, defined as aviremia at least 12 weeks after completion of antiviral therapy)",{"$nulls":4},"Actual","2018-01-26","Actual","Anticipated","2019-09-27","Anticipated","2018-01-01","2018-01-22","2018-01-22","2018-01-22","No",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Non-Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"2017-004203-41|54767414MMY2040","EudraCT Number|Janssen Research & Development, LLC","D-VMP and D-Rd Cohort: Overall Response Rate (ORR)|D-VRd Cohort: Very Good Partial Response (VGPR) or Better Rate","The ORR is defined as the percentage of participants who achieve partial response (PR) or better according to international myeloma working group (IMWG) criteria, during or after study treatment for D-VMP and D-Rd cohorts. IMWG criteria for PR: greater than or equal to (>=) 50 percent (%) reduction of serum M-protein and reduction in 24-hour urinary M-protein by >=90% or to less than (<) 200 mg/24 hours, If the serum and urine M-protein are not measurable, a decrease of >=50% in the difference between involved and uninvolved free light chain (FLC) levels is required in place of the M-protein criteria, If serum and urine M-protein are not measurable, and serum free light assay is also not measurable, >=50% reduction in bone marrow plasma cells (PCs) is required in place of M-protein, provided baseline bone marrow plasma cell percentage was >=30%. In addition to the above criteria, if present at baseline, a >=50% reduction in the size of soft tissue plasmacytomas is also required.|The VGPR or better rate, defined as the percentage of participants achieving VGPR or better according IMWG criteria during or after the study treatment in Daratumumab + Bortezomib + Lenalidomide + Dexamethasone (D-VRd) cohort. IMWG criteria for VGPR: Serum and urine M-component detectable by immunofixation but not on electrophoresis, or >= 90 percent (%) reduction in serum M-protein plus urine M-protein <100 milligram per 24 hours (mg/24 hours).","At least 6 months after the last participant enrolled (approximately 1.5 years)","Maximum Observed Serum Concentrations (Cmax) of Daratumumab|Minimum Observed Serum Concentrations (Cmin) of Daratumumab|Percentage of Participants with Infusion-Related Reactions (IRR)|D-VMP and D-Rd Cohort: Very Good Partial Response (VGPR) or Better Rate|D-VRd Cohort: Overall Response Rate (ORR)|Complete Response or Better Rate|Duration of Response (DOR)|Number of Participants with Anti-Drug Antibodies Against Daratumumab or Recombinant Human Hyaluronidase (rHuPH20)|D-VMP and D-Rd Cohorts: Percentage of Participants who are Minimal Residual Disease (MRD) Negative","Cmax is defined as maximum concentration observed following daratumumab administration.|Cmin is defined as the minimum concentration observed immediately before daratumumab administration.|The Percentage of Participants with infusion reactions will be reported.|The VGPR or better rate, defined as the percentage of participants achieving VGPR or better rate according IMWG criteria during or after the study treatment for Daratumumab + Bortezomib + Melphalan + Prednisone (D-VMP) and Daratumumab + Lenalidomide + Dexamethasone (D-Rd) cohorts. IMWG criteria for VGPR: Serum and urine M-component detectable by immunofixation but not on electrophoresis, or greater than equal to (>=) 90 percent (%) reduction in serum M-protein plus urine M-protein <100 milligram (mg)/24 hours.|The ORR is defined as the proportion of participants who achieve partial response (PR) or better according to IMWG criteria, during or after study treatment for D-VRd cohort. IMWG criteria for PR: greater than or equal to (>=) 50 percent (%) reduction of serum M-protein and reduction in 24-hour urinary M-protein by >=90% or to less than (<) 200 mg/24 hours, If the serum and urine M-protein are not measurable, a decrease of >=50% in the difference between involved and uninvolved free light chain (FLC) levels is required in place of the M-protein criteria, If serum and urine M-protein are not measurable, and serum free light assay is also not measurable, >=50% reduction in bone marrow plasma cells (PCs) is required in place of M-protein, provided baseline bone marrow plasma cell percentage was >=30%. In addition to the above criteria, if present at baseline, a >=50% reduction in the size of soft tissue plasmacytomas is also required.|Complete response is based on serum M-Protein assessments. IMWG criteria for CR: Negative immunofixation on the serum and urine, and disappearance of any soft tissue plasmacytomas, and <5% PCs in bone marrow. Stringent complete response (sCR): CR plus normal FLC ratio, and absence of clonal PCs by immunohistochemistry, immunofluorescence or 2- to 4 color flow cytometry.|Duration of response is defined as the time from the date of initial documented response (PR or better for D-VMP and D-Rd cohorts, or VGPR or better for D-VRd cohort) to the date of first documented evidence of progressive disease or death due to progressive disease (PD).|Participants with anti-drug antibodies against daratumumab or rHuPH20 will be analyzed.|Percentage of participants who are MRD negative will be assessed for D-VMP and D-Rd cohorts. MRD negative is defined as less than (<) 0.01% abnormal population counts to total event counts when measured by flow.","D-VRd: Day 4 of Cycles 1 and 4 and post treatment weeks 4 and 8; D-VMP: Day 4 of Cycles 1 and 2 and post treatment weeks 4 and 8; D-VRd: Day 4 of Cycles 1 and 2 and post treatment weeks 4 and 8|D-VRd: predose on Day 1 of Cycles 1, 3, and 4; D-VMP: predose on Day 1 of Cycles 1, 2, 3, 6 and 9 and D-Rd: predose on Day 1 of Cycles 1, 3, 6, 9 and 12|At least 6 months after last participant enrolled (approximately 1.5 years)|At least 6 months after the last participant enrolled (approximately 1.5 years)|At least 6 months after the last participant enrolled (approximately 1.5 years) and 18 months after the last participant enrolled (approximately 2.5 years)|Up to 8 weeks after the last dose of study drug (approximately 1 year)","JNJ.CT@sylogent.com","Study Contact","844-434-4210","Haifa, Israel, 31096 Carmel Medical CenterHaifa, Israel, 3436212 Hadassah Medical CenterJerusalem, Israel, 9112001 Galilee Medical CenterNahariya, Israel, 22100 Sheba Medical CenterRamat Gan, Israel, 52621 Tel-Aviv Sourasky Medical CenterTel-Aviv, Israel, 64239|Bournemouth, United Kingdom, Bh7 7Dw University Hospitals Bristol Nhs TrustBristol, United Kingdom, Bs2 8Ed Kent And Canterbury HospitalCanterbury, United Kingdom, Ct1 3Ng Ninewells HospitalDundee, United Kingdom, Dd1 9Sy Royal Stoke University HospitalStoke On Trent, United Kingdom, St4 6Qg|West Hollywood, California, United States, 90069","California","Israel|United Kingdom|United States","Rambam Medical Center|Royal Bournemouth Hospital|James R. Berenson, Md Inc.",{"$nulls":3},"Janssen Research & Development, LLC Clinical Trial","2018-01-22","2020-05-25T16:38:52.071","2020-05-26T17:10:42.972","NCT03412565"]
["5ecbf49ce2561b1b11905e5c","NCT03412565","2018-04-27","Johnson & Johnson","JNJ","Not yet recruiting","A Study to Evaluate Subcutaneous Daratumumab in Combination With Standard Multiple Myeloma Treatment Regimens","Daratumumab|Bortezomib|Lenalidomide|Dexamethasone|Melphalan|Prednisone","CD38 Inhibitor|Proteasome Inhibitor|Angiogenesis Inhibitor|GR Agonist|GR Agonist|Immunosuppressive","No",null,"No",null,"Phase 2",3,180,"Anticipated","2018-04-26","2019-09-27","RR","Response Rate",{"$nulls":3},"The purpose of this study is to evaluate the clinical benefit of subcutaneous (SC) daratumumab administered in combination with standard multiple myeloma (MM) regimens in participants with MM as measured by overall response rate (ORR) or very good partial response (VGPR) or better rate.","The hypothesis is that the addition of daratumumab administered SC to standard MM regimens will improve responses compared to response data observed in completed phase 3 studies without daratumumab. Disease evaluations will include measurements of myeloma proteins, bone marrow examinations, skeletal surveys, assessment of extramedullary plasmacytomas, and measurements of serum calcium corrected for albumin. Safety will be measured by adverse events, laboratory test results, electrocardiogram (ECGs), vital sign measurements, physical examination findings, SC injection-site assessments, and assessment of Eastern Cooperative Oncology Group (ECOG) performance status score. Study will consist of 3 phases (screening, treatment and follow-up) and duration of study is approximately 3 years.","A Multicenter Phase 2 Study to Evaluate Subcutaneous Daratumumab in Combination With Standard Multiple Myeloma Treatment Regimens","CR108435","Multiple Myeloma","Multiple Myeloma","Oncology Hematological","Oncology","Experimental","Daratumumab(D)+Bortezomib+Lenalidomide+Dexamethasone (D-VRd)|D + Bortezomib + Melphalan + Prednisone + Dexamethasone(D-VMP)|Daratumumab + Lenalidomide + Dexamethasone (D-Rd)","Participants will receive daratumumab 1800 milligram (mg) by subcutaneous (SC) injection on Days 1, 8 and 15 of Cycles 1 to 3 (each cycle of 21 days) and on Day 1 of Cycle 4; bortezomib 1.3 milligram per square meter (mg/m^2) SC injection on Days 1, 4, 8 and 11 of Cycles 1 to 4; lenalidomide 25 mg orally on Day 1 through Day 14 of Cycles 1 to 4 and dexamethasone 20 mg orally or intravenously on Days 1, 2 ,8, 9, 15 and 16 of Cycle 1 to 4.|Participants will receive daratumumab 1800 mg by SC injection on Days 1, 8, 15, 22, 29 and 36 of Cycle 1 (each cycle of 42 days) then on Days 1 and 22 in Cycles 2 to 9 and Day 1 of Cycle 10 (each cycle of 28 days) and thereafter until documented progression of disease, unacceptable toxicity, or end of study; bortezomib 1.3 mg/m^2 SC injection on Day 1, 4, 8, 11, 22, 25, 29 and 32 of Cycles 1 and on Days 1, 8, 22 and 29 of Cycles 2 to 9; melphalan 9 mg/m^2 orally on Day 1 through Day 4 of Cycles 1 to 9; prednisone 60 mg/m^2 orally on Days 2, 3 and 4 of cycles 1 to 9 and dexamethasone 20 mg orally on Days 1, 8, 15, 22, 29 and 36 of Cycle 1 and on Days 1 and 22 of Cycles 2 to 9 and and on Day 1 of Cycle 10 and thereafter until documented progression of disease, unacceptable toxicity, or end of study.|Participants will receive daratumumab 1800 mg by SC injection on Days 1, 8, 15 and 22 of Cycles 1 and 2 (each cycle of 28 days) then on Day 1 and 15 of Cycles 3 to 6 and on Day 1 of Cycle 7 and thereafter until documented progression of disease, unacceptable toxicity, or end of study; lenalidomide 25 mg orally on Day 1 through Day 21 in Cycles 1 to 7 and thereafter until documented progression of disease, unacceptable toxicity, or end of study and dexamethasone 40 mg orally or intravenously on Days 1, 8, 15 and 22 of Cycle 1 to 7 and thereafter until documented progression of disease, unacceptable toxicity, or end of study.","Drug","Daratumumab|Bortezomib|Lenalidomide|Dexamethasone|Melphalan|Prednisone","Daratumumab will be administered at a dose of 1800 mg by SC injection in Cycles 1 to 4 in D-VRd reporting group, in Cycles 1 to 10 and thereafter until documented progression of disease, unacceptable toxicity, or end of study in D-VMP reporting group and in Cycles 1 to 7 and thereafter until documented progression of disease, unacceptable toxicity, or end of study in D-Rd reporting group.|Bortezomib will be administered as 1.3 mg/m^2 SC injection in Cycles 1 to 4 in D-VRd reporting group and in Cycles 1 to 9 in D-VMP reporting group.|Lenalidomide will be administered as 25 mg capsule orally in Cycles 1 to 4 in D-VRd reporting group and in Cycles 1 to 7 and thereafter until documented progression of disease, unacceptable toxicity, or end of study in D-Rd reporting group.|Dexamethasone will be administered as 20 mg orally or intravenously in Cycles 1 to 4 in D-VRd reporting group; 20 mg orally in cycles 1 to 10 and thereafter until documented progression of disease, unacceptable toxicity, or end of study in D-VMP reporting group and 40 mg orally or intravenously in Cycles 1 to 7 and thereafter until documented progression of disease, unacceptable toxicity, or end of study in D-Rd reporting group.|Melphalan will be administered as 9 mg/m^2 orally in Cycles 1 to 9.|Prednisone will be administered as 60 mg/m^2 orally in cycles 1 to 9.",null,"Daratumumab(D)+Bortezomib+Lenalidomide+Dexamethasone (D-VRd)|D + Bortezomib + Melphalan + Prednisone + Dexamethasone(D-VMP)|Daratumumab + Lenalidomide + Dexamethasone (D-Rd)","\n\n * Multiple myeloma diagnosed according to the International Myeloma Working Group (IMWG) diagnostic criteria\n * Measurable, secretory disease as defined by any of the following: 1. Serum monoclonal paraprotein (M-protein) level greater than or equal to (>=) 1.0 gram per deciliter (g/dL); or\n    2. Urine M-protein level >= 200 milligram per 24 hours (mg/24 hours); or\n    3. Light chain multiple myeloma (MM), for participants without measurable disease in the serum or urine: serum Immunoglobulin (Ig) free light chain (FLC) >= 10 mg/dL and abnormal FLC ratio\n   \n   \n * Meets one of the sets of the following criteria: 1. For Daratumumab + bortezomib + lenalidomide + dexamethasone (D-VRd) and Daratumumab + bortezomib + melphalan + prednisone + dexamethasone (D-VMP) regimen: newly diagnosed myeloma\n    2. For Daratumumab + lenalidomide + dexamethasone (D-Rd) regimen: relapsed or refractory disease\n   \n   \n * Eastern Cooperative Oncology Group (ECOG) Performance Status grade of 0, 1, or 2\n * During the study, and for 3 months after receiving the last dose of daratumumab, a woman must agree not to donate eggs (ova, oocytes) and men must agree not to donate sperm for the purposes of assisted reproduction\n\n","\n\n * History of malignancy (other than MM) if all treatment of that malignancy was completed at least 2 years before registration and the participant has no evidence of disease (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or breast, or other non-invasive lesion, that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence within 3 years)\n * Exhibits clinical signs of meningeal involvement of MM\n * Either of the following: 1. Chronic obstructive pulmonary disease with a forced expiratory volume in 1 second (FEV1) is less than (<) 50 % of predicted normal\n    2. Moderate or severe persistent asthma, or a history of asthma within the last 2 years, or currently has uncontrolled asthma of any classification\n   \n   \n * Any of the following: 1. Seropositive for human immunodeficiency virus;\n    2. Hepatitis B (hepatitis B surface antigen [HBsAg] positive, or antibodies to hepatitis B surface or core antigens [antiHBs or antiHBc] with hepatitis B virus [HBV]- Deoxyribonucleic acid [DNA] quantitation positive). Participants who are positive for antiHBs or antiHBc must have a negative polymerase chain reaction (PCR) for HBV-DNA quantitation result at screening. Those who are polymerase chain reaction (PCR) positive will be excluded\n   \n   \n * Seropositive for hepatitis C (except in the setting of a sustained virologic response, defined as aviremia at least 12 weeks after completion of antiviral therapy)",{"$nulls":4},"Actual","2018-01-26","Actual","Anticipated","2022-03-31","Anticipated","2018-04-01","2018-01-22","2018-01-22","2018-04-26","No",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Non-Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"2017-004203-41|54767414MMY2040","EudraCT Number|Janssen Research & Development, LLC","D-VMP and D-Rd Cohort: Overall Response Rate (ORR)|D-VRd Cohort: Very Good Partial Response (VGPR) or Better Rate","The ORR is defined as the percentage of participants who achieve partial response (PR) or better according to international myeloma working group (IMWG) criteria, during or after study treatment for D-VMP and D-Rd cohorts. IMWG criteria for PR: greater than or equal to (>=) 50 percent (%) reduction of serum M-protein and reduction in 24-hour urinary M-protein by >=90% or to less than (<) 200 mg/24 hours, If the serum and urine M-protein are not measurable, a decrease of >=50% in the difference between involved and uninvolved free light chain (FLC) levels is required in place of the M-protein criteria, If serum and urine M-protein are not measurable, and serum free light assay is also not measurable, >=50% reduction in bone marrow plasma cells (PCs) is required in place of M-protein, provided baseline bone marrow plasma cell percentage was >=30%. In addition to the above criteria, if present at baseline, a >=50% reduction in the size of soft tissue plasmacytomas is also required.|The VGPR or better rate, defined as the percentage of participants achieving VGPR or better according IMWG criteria during or after the study treatment in Daratumumab + Bortezomib + Lenalidomide + Dexamethasone (D-VRd) cohort. IMWG criteria for VGPR: Serum and urine M-component detectable by immunofixation but not on electrophoresis, or >= 90 percent (%) reduction in serum M-protein plus urine M-protein <100 milligram per 24 hours (mg/24 hours).","At least 6 months after the last participant enrolled (approximately 1.5 years)","Maximum Observed Serum Concentrations (Cmax) of Daratumumab|Minimum Observed Serum Concentrations (Cmin) of Daratumumab|Percentage of Participants with Infusion-Related Reactions (IRR)|D-VMP and D-Rd Cohort: Very Good Partial Response (VGPR) or Better Rate|D-VRd Cohort: Overall Response Rate (ORR)|Complete Response or Better Rate|Duration of Response (DOR)|Number of Participants with Anti-Drug Antibodies Against Daratumumab or Recombinant Human Hyaluronidase (rHuPH20)|D-VMP and D-Rd Cohorts: Percentage of Participants who are Minimal Residual Disease (MRD) Negative","Cmax is defined as maximum concentration observed following daratumumab administration.|Cmin is defined as the minimum concentration observed immediately before daratumumab administration.|The Percentage of Participants with infusion reactions will be reported.|The VGPR or better rate, defined as the percentage of participants achieving VGPR or better rate according IMWG criteria during or after the study treatment for Daratumumab + Bortezomib + Melphalan + Prednisone (D-VMP) and Daratumumab + Lenalidomide + Dexamethasone (D-Rd) cohorts. IMWG criteria for VGPR: Serum and urine M-component detectable by immunofixation but not on electrophoresis, or greater than equal to (>=) 90 percent (%) reduction in serum M-protein plus urine M-protein <100 milligram (mg)/24 hours.|The ORR is defined as the proportion of participants who achieve partial response (PR) or better according to IMWG criteria, during or after study treatment for D-VRd cohort. IMWG criteria for PR: greater than or equal to (>=) 50 percent (%) reduction of serum M-protein and reduction in 24-hour urinary M-protein by >=90% or to less than (<) 200 mg/24 hours, If the serum and urine M-protein are not measurable, a decrease of >=50% in the difference between involved and uninvolved free light chain (FLC) levels is required in place of the M-protein criteria, If serum and urine M-protein are not measurable, and serum free light assay is also not measurable, >=50% reduction in bone marrow plasma cells (PCs) is required in place of M-protein, provided baseline bone marrow plasma cell percentage was >=30%. In addition to the above criteria, if present at baseline, a >=50% reduction in the size of soft tissue plasmacytomas is also required.|Complete response is based on serum M-Protein assessments. IMWG criteria for CR: Negative immunofixation on the serum and urine, and disappearance of any soft tissue plasmacytomas, and <5% PCs in bone marrow. Stringent complete response (sCR): CR plus normal FLC ratio, and absence of clonal PCs by immunohistochemistry, immunofluorescence or 2- to 4 color flow cytometry.|Duration of response is defined as the time from the date of initial documented response (PR or better for D-VMP and D-Rd cohorts, or VGPR or better for D-VRd cohort) to the date of first documented evidence of progressive disease or death due to progressive disease (PD).|Participants with anti-drug antibodies against daratumumab or rHuPH20 will be analyzed.|Percentage of participants who are MRD negative will be assessed for D-VMP and D-Rd cohorts. MRD negative is defined as less than (<) 0.01% abnormal population counts to total event counts when measured by flow.","D-VRd: Day 4 of Cycles 1 and 4 and post treatment weeks 4 and 8; D-VMP: Day 4 of Cycles 1 and 2 and post treatment weeks 4 and 8; D-VRd: Day 4 of Cycles 1 and 2 and post treatment weeks 4 and 8|D-VRd: predose on Day 1 of Cycles 1, 3, and 4; D-VMP: predose on Day 1 of Cycles 1, 2, 3, 6 and 9 and D-Rd: predose on Day 1 of Cycles 1, 3, 6, 9 and 12|At least 6 months after last participant enrolled (approximately 1.5 years)|At least 6 months after the last participant enrolled (approximately 1.5 years)|At least 6 months after the last participant enrolled (approximately 1.5 years) and 18 months after the last participant enrolled (approximately 2.5 years)|Up to 8 weeks after the last dose of study drug (approximately 1 year)","JNJ.CT@sylogent.com","Study Contact","844-434-4210","Fortaleza, Brazil, 60430-230 Liga Norte Riograndense Contra O CancerNatal, Brazil, 59075-740 Centro De Pesquisa Do Instituto Do CÃ¢ncer- Hospital SÃ£o Vicente De PauloPasso Fundo, Brazil, 99010-090 Hospital MÃ£e De Deus CenterPorto Alegre, Brazil, 90470-340 Instituto Nacional Do Cancer - IncaRio De Janeiro, Brazil, 20230-130 Universidade Federal De Sao PauloSao Paulo, Brazil, 04037-002 Hospital Do Servidor Publico Estadual - IamspeSao Paulo, Brazil Clinica Sao GermanoSÃ£o Paulo, Brazil, 01455-010|Brno, Czechia, 625 00 Fakultni Nemocnice Hradec KraloveHradec Kralove, Czechia, 500 05 Fakultni Nemocnice OstravaOstrava, Czechia, 70852 Vseobecna Fakultni Nemocnice V Praze - I. Interni Klinika - Klinika HematologiePraha 2, Czechia, 128 08|Nantes Cedex 1, France, 44093 Chu De Bordeaux - HÃ´pital Haut-LÃ©vÃªquePessac Cedex, France, 33604 Centre Hospitalier Lyon-SudPierre-BÃ©nite, France, 69495 Chu BretonneauTours Cedex 9, France, 37044 Chu Nancy BraboisVandoeuvre Les Nancy, France, 54511|Chemnitz, Germany, 09113 Asklepios Klinik AltonaHamburg, Germany, 22763 Universitaetsklinikum HeidelbergHeidelberg, Germany, 69120 Universitaetsklinikum Tuebingen Der Eberhard-Karls-Universitaet, Abteilung Fuer Innere Medizin Ii,TÃ¼bingen, Germany, 72076|Haifa, Israel, 31096 Carmel Medical CenterHaifa, Israel, 3436212 Hadassah Medical CenterJerusalem, Israel, 9112001 Galilee Medical CenterNahariya, Israel, 22100 Sheba Medical CenterRamat Gan, Israel, 52621 Tel-Aviv Sourasky Medical CenterTel-Aviv, Israel, 64239|Kanazawa, Japan, 920-8641 Matsuyama Red Cross HospitalMatsuyama, Japan, 790-8524 Nagoya City University HospitalNagoya, Japan, 467-8602 Japanese Red Cross Central Medical CenterShibuya, Japan, 150-8935|Badalona, Spain, 08916 Hosp. Univ. Vall D HebronBarcelona, Spain, 08035 Hosp. Clinic I Provincial De BarcelonaBarcelona, Spain, 08036 Inst. Cat. Doncologia-H Duran I ReynalsBarcelona, Spain, 08908 Hosp. Gral. Univ. Gregorio MaranonMadrid, Spain, 28007 Hosp. Univ. Ramon Y CajalMadrid, Spain, 28034 Hosp. Univ. 12 De OctubreMadrid, Spain, 28041 Hosp. Son LlatzerMallorca, Spain, 07198 Clinica Univ. De NavarraPamplona, Spain, 31008 Hosp. Clinico Univ. De SalamancaSalamanca, Spain, 37007 Hosp. Univ. Dr. PesetValencia, Spain, 46017|Birmingham, United Kingdom, B9 5Ss Royal Bournemouth HospitalBournemouth, United Kingdom, Bh7 7Dw Kent And Canterbury HospitalCanterbury, United Kingdom, Ct1 3Ng Manchester Royal InfirmaryManchester, United Kingdom, M13 9Wl Derriford HospitalPlymouth, United Kingdom, Pl6 8Dh Royal Stoke University HospitalStoke On Trent, United Kingdom, St4 6Qg|Farmington, Connecticut, United States, 06030 Cancer Center Of Central Connecticut - SouthingtonSouthington, Connecticut, United States, 06489-3237|Jacksonville, Florida, United States, 32224 Watson Clinic LlpLakeland, Florida, United States, 33805 Uf Health Cancer Center At Orlando HealthOrlando, Florida, United States, 32806|Iowa City, Iowa, United States, 52242|Baltimore, Maryland, United States, 21201|Detroit, Michigan, United States, 48201 Providence Cancer CenterSouthfield, Michigan, United States, 48075|Billings, Montana, United States, 59101|Lincoln, Nebraska, United States, 68506 Southeast Nebraska Cancer CenterLincoln, Nebraska, United States, 68510 Nebraska Cancer SpecialistsOmaha, Nebraska, United States, 68130 University Of Nebraska Medical CenterOmaha, Nebraska, United States, 68198|Ridgewood, New Jersey, United States, 07450|Farmington, New|East Hills, New York, United States, 11548 Queens Medical Associates, PcFresh Meadows, New York, United States, 11366 Northwell HealthLake Success, New York, United States, 11042 Nyu WinthropMineola, New York, United States, 11501 Mt. Sinai School Of MedicineNew York, New York, United States, 10029|Chapel Hill, North Carolina, United States, 27599 Wake Forest University Baptist Medical Center (Wfubmc) - Comprehensive Cancer CenterWinston-Salem, North Carolina, United States, 27157|Sioux Falls, South Dakota, United States, 57105|Salt Lake City, Utah, United States, 84121|Charlottesville, Virginia, United States, 22903|Seattle, Washington, United States, 98101","Connecticut|Florida|Iowa|Maryland|Michigan|Montana|Nebraska|New Jersey|New Mexico|New York|North Carolina|South Dakota|Utah|Virginia|Washington","Brazil|Czechia|France|Germany|Israel|Japan|Spain|United Kingdom|United States","Instituto Do Cancer Do Ceara|Fakultni Nemocnice Brno|Chu De Nantes HÃ´tel-Dieu|Klinikum Chemnitz Ggmbh|Rambam Medical Center|Kanazawa University Hospital|Hosp. Univ. Germans Trias I Pujol|Heart Of England Nhs Foundation Trust|University Of Connecticut|Mayo Clinic In Florida|University Of Iowa Hospitals & Clinics|University Of Maryland|Karmonos Cancer Institute|Billings Clinic|Nebraska Hematology And Oncology|The Valley Hospital|San Juan Oncology Associates|St Francis Hospital|University Of North Carolina|Avera Medical Group - Oncology & Hematology|Utah Cancer Specialists|University Of Virginia Cancer Center - Emily Couric Clinical Cancer Center - Women's Oncology Clini|Virginia Mason Medical Center",{"$nulls":3},"Janssen Research & Development, LLC Clinical Trial","2018-04-26","2020-05-25T16:38:52.122","2020-05-26T17:10:42.972","NCT03412565"]
["5ecbf49c307e3d1b1f8d9df4","NCT03412565","2018-05-29","Johnson & Johnson","JNJ","Recruiting","A Study to Evaluate Subcutaneous Daratumumab in Combination With Standard Multiple Myeloma Treatment Regimens","Daratumumab|Bortezomib|Lenalidomide|Dexamethasone|Melphalan|Prednisone","CD38 Inhibitor|Proteasome Inhibitor|Angiogenesis Inhibitor|GR Agonist|GR Agonist|Immunosuppressive","No",null,"No",null,"Phase 2",3,180,"Anticipated","2018-04-26","2019-09-27","RR","Response Rate",{"$nulls":3},"The purpose of this study is to evaluate the clinical benefit of subcutaneous (SC) daratumumab administered in combination with standard multiple myeloma (MM) regimens in participants with MM as measured by overall response rate (ORR) or very good partial response (VGPR) or better rate.","The hypothesis is that the addition of daratumumab administered SC to standard MM regimens will improve responses compared to response data observed in completed phase 3 studies without daratumumab. Disease evaluations will include measurements of myeloma proteins, bone marrow examinations, skeletal surveys, assessment of extramedullary plasmacytomas, and measurements of serum calcium corrected for albumin. Safety will be measured by adverse events, laboratory test results, electrocardiogram (ECGs), vital sign measurements, physical examination findings, SC injection-site assessments, and assessment of Eastern Cooperative Oncology Group (ECOG) performance status score. Study will consist of 3 phases (screening, treatment and follow-up) and duration of study is approximately 3 years.","A Multicenter Phase 2 Study to Evaluate Subcutaneous Daratumumab in Combination With Standard Multiple Myeloma Treatment Regimens","CR108435","Multiple Myeloma","Multiple Myeloma","Oncology Hematological","Oncology","Experimental","Daratumumab(D)+Bortezomib+Lenalidomide+Dexamethasone (D-VRd)|D + Bortezomib + Melphalan + Prednisone + Dexamethasone(D-VMP)|Daratumumab + Lenalidomide + Dexamethasone (D-Rd)","Participants will receive daratumumab 1800 milligram (mg) by subcutaneous (SC) injection on Days 1, 8 and 15 of Cycles 1 to 3 (each cycle of 21 days) and on Day 1 of Cycle 4; bortezomib 1.3 milligram per square meter (mg/m^2) SC injection on Days 1, 4, 8 and 11 of Cycles 1 to 4; lenalidomide 25 mg orally on Day 1 through Day 14 of Cycles 1 to 4 and dexamethasone 20 mg orally or intravenously on Days 1, 2 ,8, 9, 15 and 16 of Cycle 1 to 4.|Participants will receive daratumumab 1800 mg by SC injection on Days 1, 8, 15, 22, 29 and 36 of Cycle 1 (each cycle of 42 days) then on Days 1 and 22 in Cycles 2 to 9 and Day 1 of Cycle 10 (each cycle of 28 days) and thereafter until documented progression of disease, unacceptable toxicity, or end of study; bortezomib 1.3 mg/m^2 SC injection on Day 1, 4, 8, 11, 22, 25, 29 and 32 of Cycles 1 and on Days 1, 8, 22 and 29 of Cycles 2 to 9; melphalan 9 mg/m^2 orally on Day 1 through Day 4 of Cycles 1 to 9; prednisone 60 mg/m^2 orally on Days 2, 3 and 4 of cycles 1 to 9 and dexamethasone 20 mg orally on Days 1, 8, 15, 22, 29 and 36 of Cycle 1 and on Days 1 and 22 of Cycles 2 to 9 and and on Day 1 of Cycle 10 and thereafter until documented progression of disease, unacceptable toxicity, or end of study.|Participants will receive daratumumab 1800 mg by SC injection on Days 1, 8, 15 and 22 of Cycles 1 and 2 (each cycle of 28 days) then on Day 1 and 15 of Cycles 3 to 6 and on Day 1 of Cycle 7 and thereafter until documented progression of disease, unacceptable toxicity, or end of study; lenalidomide 25 mg orally on Day 1 through Day 21 in Cycles 1 to 7 and thereafter until documented progression of disease, unacceptable toxicity, or end of study and dexamethasone 40 mg orally or intravenously on Days 1, 8, 15 and 22 of Cycle 1 to 7 and thereafter until documented progression of disease, unacceptable toxicity, or end of study.","Drug","Daratumumab|Bortezomib|Lenalidomide|Dexamethasone|Melphalan|Prednisone","Daratumumab will be administered at a dose of 1800 mg by SC injection in Cycles 1 to 4 in D-VRd reporting group, in Cycles 1 to 10 and thereafter until documented progression of disease, unacceptable toxicity, or end of study in D-VMP reporting group and in Cycles 1 to 7 and thereafter until documented progression of disease, unacceptable toxicity, or end of study in D-Rd reporting group.|Bortezomib will be administered as 1.3 mg/m^2 SC injection in Cycles 1 to 4 in D-VRd reporting group and in Cycles 1 to 9 in D-VMP reporting group.|Lenalidomide will be administered as 25 mg capsule orally in Cycles 1 to 4 in D-VRd reporting group and in Cycles 1 to 7 and thereafter until documented progression of disease, unacceptable toxicity, or end of study in D-Rd reporting group.|Dexamethasone will be administered as 20 mg orally or intravenously in Cycles 1 to 4 in D-VRd reporting group; 20 mg orally in cycles 1 to 10 and thereafter until documented progression of disease, unacceptable toxicity, or end of study in D-VMP reporting group and 40 mg orally or intravenously in Cycles 1 to 7 and thereafter until documented progression of disease, unacceptable toxicity, or end of study in D-Rd reporting group.|Melphalan will be administered as 9 mg/m^2 orally in Cycles 1 to 9.|Prednisone will be administered as 60 mg/m^2 orally in cycles 1 to 9.",null,"Daratumumab(D)+Bortezomib+Lenalidomide+Dexamethasone (D-VRd)|D + Bortezomib + Melphalan + Prednisone + Dexamethasone(D-VMP)|Daratumumab + Lenalidomide + Dexamethasone (D-Rd)","\n\n * Multiple myeloma diagnosed according to the International Myeloma Working Group (IMWG) diagnostic criteria\n * Measurable, secretory disease as defined by any of the following: 1. Serum monoclonal paraprotein (M-protein) level greater than or equal to (>=) 1.0 gram per deciliter (g/dL); or\n    2. Urine M-protein level >= 200 milligram per 24 hours (mg/24 hours); or\n    3. Light chain multiple myeloma (MM), for participants without measurable disease in the serum or urine: serum Immunoglobulin (Ig) free light chain (FLC) >= 10 mg/dL and abnormal FLC ratio\n   \n   \n * Meets one of the sets of the following criteria: 1. For Daratumumab + bortezomib + lenalidomide + dexamethasone (D-VRd) and Daratumumab + bortezomib + melphalan + prednisone + dexamethasone (D-VMP) regimen: newly diagnosed myeloma\n    2. For Daratumumab + lenalidomide + dexamethasone (D-Rd) regimen: relapsed or refractory disease\n   \n   \n * Eastern Cooperative Oncology Group (ECOG) Performance Status grade of 0, 1, or 2\n * During the study, and for 3 months after receiving the last dose of daratumumab, a woman must agree not to donate eggs (ova, oocytes) and men must agree not to donate sperm for the purposes of assisted reproduction\n\n","\n\n * History of malignancy (other than MM) if all treatment of that malignancy was completed at least 2 years before registration and the participant has no evidence of disease (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or breast, or other non-invasive lesion, that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence within 3 years)\n * Exhibits clinical signs of meningeal involvement of MM\n * Either of the following: 1. Chronic obstructive pulmonary disease with a forced expiratory volume in 1 second (FEV1) is less than (<) 50 % of predicted normal\n    2. Moderate or severe persistent asthma, or a history of asthma within the last 2 years, or currently has uncontrolled asthma of any classification\n   \n   \n * Any of the following: 1. Seropositive for human immunodeficiency virus;\n    2. Hepatitis B (hepatitis B surface antigen [HBsAg] positive, or antibodies to hepatitis B surface or core antigens [antiHBs or antiHBc] with hepatitis B virus [HBV]- Deoxyribonucleic acid [DNA] quantitation positive). Participants who are positive for antiHBs or antiHBc must have a negative polymerase chain reaction (PCR) for HBV-DNA quantitation result at screening. Those who are polymerase chain reaction (PCR) positive will be excluded\n   \n   \n * Seropositive for hepatitis C (except in the setting of a sustained virologic response, defined as aviremia at least 12 weeks after completion of antiviral therapy)",{"$nulls":4},"Actual","2018-01-26","Actual","Anticipated","2022-03-31","Anticipated","2018-05-01","2018-01-22","2018-01-22","2018-05-24","No",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Non-Randomized","18 Years",null,"All",null,"No",null,null,"URL: http://pam.sylogent.com/cr/CR108435 [http://pam.sylogent.com/cr/CR108435] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To learn how to participate in this trial please click here.",null,"Yes","No",{"$nulls":17},"2017-004203-41|54767414MMY2040","EudraCT Number|Janssen Research & Development, LLC","D-VMP and D-Rd Cohort: Overall Response Rate (ORR)|D-VRd Cohort: Very Good Partial Response (VGPR) or Better Rate","The ORR is defined as the percentage of participants who achieve partial response (PR) or better according to international myeloma working group (IMWG) criteria, during or after study treatment for D-VMP and D-Rd cohorts. IMWG criteria for PR: greater than or equal to (>=) 50 percent (%) reduction of serum M-protein and reduction in 24-hour urinary M-protein by >=90% or to less than (<) 200 mg/24 hours, If the serum and urine M-protein are not measurable, a decrease of >=50% in the difference between involved and uninvolved free light chain (FLC) levels is required in place of the M-protein criteria, If serum and urine M-protein are not measurable, and serum free light assay is also not measurable, >=50% reduction in bone marrow plasma cells (PCs) is required in place of M-protein, provided baseline bone marrow plasma cell percentage was >=30%. In addition to the above criteria, if present at baseline, a >=50% reduction in the size of soft tissue plasmacytomas is also required.|The VGPR or better rate, defined as the percentage of participants achieving VGPR or better according IMWG criteria during or after the study treatment in Daratumumab + Bortezomib + Lenalidomide + Dexamethasone (D-VRd) cohort. IMWG criteria for VGPR: Serum and urine M-component detectable by immunofixation but not on electrophoresis, or >= 90 percent (%) reduction in serum M-protein plus urine M-protein <100 milligram per 24 hours (mg/24 hours).","At least 6 months after the last participant enrolled (approximately 1.5 years)","Maximum Observed Serum Concentrations (Cmax) of Daratumumab|Minimum Observed Serum Concentrations (Cmin) of Daratumumab|Percentage of Participants with Infusion-Related Reactions (IRR)|D-VMP and D-Rd Cohort: Very Good Partial Response (VGPR) or Better Rate|D-VRd Cohort: Overall Response Rate (ORR)|Complete Response or Better Rate|Duration of Response (DOR)|Number of Participants with Anti-Drug Antibodies Against Daratumumab or Recombinant Human Hyaluronidase (rHuPH20)|D-VMP and D-Rd Cohorts: Percentage of Participants who are Minimal Residual Disease (MRD) Negative","Cmax is defined as maximum concentration observed following daratumumab administration.|Cmin is defined as the minimum concentration observed immediately before daratumumab administration.|The Percentage of Participants with infusion reactions will be reported.|The VGPR or better rate, defined as the percentage of participants achieving VGPR or better rate according IMWG criteria during or after the study treatment for Daratumumab + Bortezomib + Melphalan + Prednisone (D-VMP) and Daratumumab + Lenalidomide + Dexamethasone (D-Rd) cohorts. IMWG criteria for VGPR: Serum and urine M-component detectable by immunofixation but not on electrophoresis, or greater than equal to (>=) 90 percent (%) reduction in serum M-protein plus urine M-protein <100 milligram (mg)/24 hours.|The ORR is defined as the proportion of participants who achieve partial response (PR) or better according to IMWG criteria, during or after study treatment for D-VRd cohort. IMWG criteria for PR: greater than or equal to (>=) 50 percent (%) reduction of serum M-protein and reduction in 24-hour urinary M-protein by >=90% or to less than (<) 200 mg/24 hours, If the serum and urine M-protein are not measurable, a decrease of >=50% in the difference between involved and uninvolved free light chain (FLC) levels is required in place of the M-protein criteria, If serum and urine M-protein are not measurable, and serum free light assay is also not measurable, >=50% reduction in bone marrow plasma cells (PCs) is required in place of M-protein, provided baseline bone marrow plasma cell percentage was >=30%. In addition to the above criteria, if present at baseline, a >=50% reduction in the size of soft tissue plasmacytomas is also required.|Complete response is based on serum M-Protein assessments. IMWG criteria for CR: Negative immunofixation on the serum and urine, and disappearance of any soft tissue plasmacytomas, and <5% PCs in bone marrow. Stringent complete response (sCR): CR plus normal FLC ratio, and absence of clonal PCs by immunohistochemistry, immunofluorescence or 2- to 4 color flow cytometry.|Duration of response is defined as the time from the date of initial documented response (PR or better for D-VMP and D-Rd cohorts, or VGPR or better for D-VRd cohort) to the date of first documented evidence of progressive disease or death due to progressive disease (PD).|Participants with anti-drug antibodies against daratumumab or rHuPH20 will be analyzed.|Percentage of participants who are MRD negative will be assessed for D-VMP and D-Rd cohorts. MRD negative is defined as less than (<) 0.01% abnormal population counts to total event counts when measured by flow.","D-VRd: Day 4 of Cycles 1 and 4 and post treatment weeks 4 and 8; D-VMP: Day 4 of Cycles 1 and 2 and post treatment weeks 4 and 8; D-VRd: Day 4 of Cycles 1 and 2 and post treatment weeks 4 and 8|D-VRd: predose on Day 1 of Cycles 1, 3, and 4; D-VMP: predose on Day 1 of Cycles 1, 2, 3, 6 and 9 and D-Rd: predose on Day 1 of Cycles 1, 3, 6, 9 and 12|At least 6 months after last participant enrolled (approximately 1.5 years)|At least 6 months after the last participant enrolled (approximately 1.5 years)|At least 6 months after the last participant enrolled (approximately 1.5 years) and 18 months after the last participant enrolled (approximately 2.5 years)|Up to 8 weeks after the last dose of study drug (approximately 1 year)","JNJ.CT@sylogent.com","Study Contact","844-434-4210","Fortaleza, Brazil, 60430-230 Liga Norte Riograndense Contra O CancerNatal, Brazil, 59075-740 Centro De Pesquisa Do Instituto Do CÃ¢ncer- Hospital SÃ£o Vicente De PauloPasso Fundo, Brazil, 99010-090 Hospital MÃ£e De Deus CenterPorto Alegre, Brazil, 90470-340 Instituto Nacional Do Cancer - IncaRio De Janeiro, Brazil, 20230-130 Universidade Federal De Sao PauloSao Paulo, Brazil, 04037-002 Hospital Do Servidor Publico Estadual - IamspeSao Paulo, Brazil Clinica Sao GermanoSÃ£o Paulo, Brazil, 01455-010|Brno, Czechia, 625 00 Fakultni Nemocnice Hradec KraloveHradec Kralove, Czechia, 500 05 Fakultni Nemocnice OstravaOstrava, Czechia, 70852 Vseobecna Fakultni Nemocnice V Praze - I. Interni Klinika - Klinika HematologiePraha 2, Czechia, 128 08|Nantes Cedex 1, France, 44093 Chu De Bordeaux - HÃ´pital Haut-LÃ©vÃªquePessac Cedex, France, 33604 Centre Hospitalier Lyon-SudPierre-BÃ©nite, France, 69495 Chu BretonneauTours Cedex 9, France, 37044 Chu Nancy BraboisVandoeuvre Les Nancy, France, 54511|Chemnitz, Germany, 09113 Asklepios Klinik AltonaHamburg, Germany, 22763 Universitaetsklinikum HeidelbergHeidelberg, Germany, 69120 Universitaetsklinikum Tuebingen Der Eberhard-Karls-Universitaet, Abteilung Fuer Innere Medizin Ii,TÃ¼bingen, Germany, 72076|Haifa, Israel, 31096 Carmel Medical CenterHaifa, Israel, 3436212 Hadassah Medical CenterJerusalem, Israel, 9112001 Galilee Medical CenterNahariya, Israel, 22100 Sheba Medical CenterRamat Gan, Israel, 52621 Tel-Aviv Sourasky Medical CenterTel-Aviv, Israel, 64239|Kanazawa, Japan, 920-8641 Matsuyama Red Cross HospitalMatsuyama, Japan, 790-8524 Nagoya City University HospitalNagoya, Japan, 467-8602 Japanese Red Cross Central Medical CenterShibuya, Japan, 150-8935|Badalona, Spain, 08916 Hosp. Univ. Vall D HebronBarcelona, Spain, 08035 Hosp. Clinic I Provincial De BarcelonaBarcelona, Spain, 08036 Inst. Cat. Doncologia-H Duran I ReynalsBarcelona, Spain, 08908 Hosp. Gral. Univ. Gregorio MaranonMadrid, Spain, 28007 Clinica Univ. De NavarraMadrid, Spain, 28027 Hosp. Univ. Ramon Y CajalMadrid, Spain, 28034 Hosp. Univ. 12 De OctubreMadrid, Spain, 28041 Hosp. Son LlatzerMallorca, Spain, 07198 Clinica Univ. De NavarraPamplona, Spain, 31008 Hosp. Clinico Univ. De SalamancaSalamanca, Spain, 37007 Hosp. Univ. Dr. PesetValencia, Spain, 46017|Birmingham, United Kingdom, B9 5Ss Royal Bournemouth HospitalBournemouth, United Kingdom, Bh7 7Dw Kent And Canterbury HospitalCanterbury, United Kingdom, Ct1 3Ng Manchester Royal InfirmaryManchester, United Kingdom, M13 9Wl Derriford HospitalPlymouth, United Kingdom, Pl6 8Dh Royal Stoke University HospitalStoke On Trent, United Kingdom, St4 6Qg|Farmington, Connecticut, United States, 06030 Cancer Center Of Central Connecticut - SouthingtonSouthington, Connecticut, United States, 06489-3237|Jacksonville, Florida, United States, 32224 Watson Clinic LlpLakeland, Florida, United States, 33805 Uf Health Cancer Center At Orlando HealthOrlando, Florida, United States, 32806|Iowa City, Iowa, United States, 52242|Baltimore, Maryland, United States, 21201|Detroit, Michigan, United States, 48201 Providence Cancer CenterSouthfield, Michigan, United States, 48075|Billings, Montana, United States, 59101|Lincoln, Nebraska, United States, 68506 Southeast Nebraska Cancer CenterLincoln, Nebraska, United States, 68510 Nebraska Cancer SpecialistsOmaha, Nebraska, United States, 68130 University Of Nebraska Medical CenterOmaha, Nebraska, United States, 68198|Ridgewood, New Jersey, United States, 07450|Farmington, New|East Hills, New York, United States, 11548 Queens Medical Associates, PcFresh Meadows, New York, United States, 11366 Northwell HealthLake Success, New York, United States, 11042 Nyu WinthropMineola, New York, United States, 11501 Mt. Sinai School Of MedicineNew York, New York, United States, 10029|Chapel Hill, North Carolina, United States, 27599 Wake Forest University Baptist Medical Center (Wfubmc) - Comprehensive Cancer CenterWinston-Salem, North Carolina, United States, 27157|Sioux Falls, South Dakota, United States, 57105|Salt Lake City, Utah, United States, 84121|Charlottesville, Virginia, United States, 22903|Seattle, Washington, United States, 98101","Connecticut|Florida|Iowa|Maryland|Michigan|Montana|Nebraska|New Jersey|New Mexico|New York|North Carolina|South Dakota|Utah|Virginia|Washington","Brazil|Czechia|France|Germany|Israel|Japan|Spain|United Kingdom|United States","Instituto Do Cancer Do Ceara|Fakultni Nemocnice Brno|Chu De Nantes HÃ´tel-Dieu|Klinikum Chemnitz Ggmbh|Rambam Medical Center|Kanazawa University Hospital|Hosp. Univ. Germans Trias I Pujol|Heart Of England Nhs Foundation Trust|University Of Connecticut|Mayo Clinic In Florida|University Of Iowa Hospitals & Clinics|University Of Maryland|Karmonos Cancer Institute|Billings Clinic|Nebraska Hematology And Oncology|The Valley Hospital|San Juan Oncology Associates|St Francis Hospital|University Of North Carolina|Avera Medical Group - Oncology & Hematology|Utah Cancer Specialists|University Of Virginia Cancer Center - Emily Couric Clinical Cancer Center - Women's Oncology Clini|Virginia Mason Medical Center",{"$nulls":3},"Janssen Research & Development, LLC Clinical Trial","2018-05-24","2020-05-25T16:38:52.298","2020-05-26T17:10:42.972","NCT03412565"]
["5ecbf49cfeab101b15530992","NCT03412565","2018-07-10","Johnson & Johnson","JNJ","Recruiting","A Study to Evaluate Subcutaneous Daratumumab in Combination With Standard Multiple Myeloma Treatment Regimens","Daratumumab|Bortezomib|Lenalidomide|Dexamethasone|Melphalan|Prednisone","CD38 Inhibitor|Proteasome Inhibitor|Angiogenesis Inhibitor|GR Agonist|GR Agonist|Immunosuppressive","No",null,"No",null,"Phase 2",3,180,"Anticipated","2018-04-26","2019-09-27","RR","Response Rate",{"$nulls":3},"The purpose of this study is to evaluate the clinical benefit of subcutaneous (SC) daratumumab administered in combination with standard multiple myeloma (MM) regimens in participants with MM as measured by overall response rate (ORR) or very good partial response (VGPR) or better rate.","The hypothesis is that the addition of daratumumab administered SC to standard MM regimens will improve responses compared to response data observed in completed phase 3 studies without daratumumab. Disease evaluations will include measurements of myeloma proteins, bone marrow examinations, skeletal surveys, assessment of extramedullary plasmacytomas, and measurements of serum calcium corrected for albumin. Safety will be measured by adverse events, laboratory test results, electrocardiogram (ECGs), vital sign measurements, physical examination findings, SC injection-site assessments, and assessment of Eastern Cooperative Oncology Group (ECOG) performance status score. Study will consist of 3 phases (screening, treatment and follow-up) and duration of study is approximately 3 years.","A Multicenter Phase 2 Study to Evaluate Subcutaneous Daratumumab in Combination With Standard Multiple Myeloma Treatment Regimens","CR108435","Multiple Myeloma","Multiple Myeloma","Oncology Hematological","Oncology","Experimental","Daratumumab(D)+Bortezomib+Lenalidomide+Dexamethasone (D-VRd)|D + Bortezomib + Melphalan + Prednisone (D-VMP)|Daratumumab + Lenalidomide + Dexamethasone (D-Rd)","Participants will receive daratumumab 1800 milligram (mg) by subcutaneous (SC) injection on Days 1, 8 and 15 of Cycles 1 to 3 (each cycle of 21 days) and on Day 1 of Cycle 4; bortezomib 1.3 milligram per square meter (mg/m^2) SC injection on Days 1, 4, 8 and 11 of Cycles 1 to 4; lenalidomide 25 mg orally on Day 1 through Day 14 of Cycles 1 to 4 and dexamethasone 20 mg orally or intravenously on Days 1, 2 ,8, 9, 15 and 16 of Cycle 1 to 4.|Participants will receive daratumumab 1800 mg by SC injection on Days 1, 8, 15, 22, 29 and 36 of Cycle 1 then on Days 1 and 22 in Cycles 2 to 9 and Day 1 of Cycle 10 and thereafter until documented progression of disease, unacceptable toxicity, or end of study; bortezomib 1.3 mg/m^2 SC injection on Day 1, 4, 8, 11, 22, 25, 29 and 32 of Cycle 1 and on Days 1, 8, 22 and 29 of Cycles 2 to 9; melphalan 9 mg/m^2 orally on Day 1 through Day 4 of Cycles 1 to 9; prednisone 60 mg/m^2 orally on Days 1 to 4 of cycles 1 to 9.|Participants will receive daratumumab 1800 mg by SC injection on Days 1, 8, 15 and 22 of Cycles 1 and 2 then on Day 1 and 15 of Cycles 3 to 6 and on Day 1 of Cycle 7 and thereafter until documented progression of disease, unacceptable toxicity, or end of study; lenalidomide 25 mg orally on Day 1 through Day 21 of each cycle until documented progression of disease, unacceptable toxicity, or end of study and dexamethasone 40 mg orally or intravenously weekly until documented progression of disease, unacceptable toxicity, or end of study.","Drug","Daratumumab|Bortezomib|Lenalidomide|Dexamethasone|Melphalan|Prednisone","Daratumumab will be administered at a dose of 1800 mg by SC injection in Cycles 1 to 4 in D-VRd cohort and until documented progression of disease, unacceptable toxicity, or end of study for D-VMP and D-Rd cohorts.|Bortezomib will be administered as 1.3 mg/m^2 SC injection in Cycles 1 to 4 in D-VRd cohort and in Cycles 1 to 9 in D-VMP cohort.|Lenalidomide will be administered as 25 mg capsule orally in Cycles 1 to 4 in D-VRd cohort and in all Cycles until documented progression of disease, unacceptable toxicity, or end of study in D-Rd cohort.|Dexamethasone will be administered as 20 mg orally or intravenously in Cycles 1 to 4 in D-VRd cohort; 40 mg orally or intravenously in all cycles and thereafter until documented progression of disease, unacceptable toxicity, or end of study in D-Rd cohort.|Melphalan will be administered as 9 mg/m^2 orally in Cycles 1 to 9.|Prednisone will be administered as 60 mg/m^2 orally in cycles 1 to 9.",null,"Daratumumab(D)+Bortezomib+Lenalidomide+Dexamethasone (D-VRd)|D + Bortezomib + Melphalan + Prednisone (D-VMP)|Daratumumab + Lenalidomide + Dexamethasone (D-Rd)","\n\n * Multiple myeloma diagnosed according to the International Myeloma Working Group (IMWG) diagnostic criteria\n * Measurable, secretory disease as defined by any of the following: 1. Serum monoclonal paraprotein (M-protein) level greater than or equal to (>=) 1.0 gram per deciliter (g/dL); or\n    2. Urine M-protein level >= 200 milligram per 24 hours (mg/24 hours); or\n    3. Light chain multiple myeloma (MM), for participants without measurable disease in the serum or urine: serum Immunoglobulin (Ig) free light chain (FLC) >= 10 mg/dL and abnormal FLC ratio\n   \n   \n * Meets one of the sets of the following criteria: 1. For Daratumumab + bortezomib + lenalidomide + dexamethasone (D-VRd) and Daratumumab + bortezomib + melphalan + prednisone + dexamethasone (D-VMP) regimen: newly diagnosed myeloma\n    2. For Daratumumab + lenalidomide + dexamethasone (D-Rd) regimen: relapsed or refractory disease\n   \n   \n * Eastern Cooperative Oncology Group (ECOG) Performance Status grade of 0, 1, or 2\n * During the study, and for 3 months after receiving the last dose of daratumumab, a woman must agree not to donate eggs (ova, oocytes) and men must agree not to donate sperm for the purposes of assisted reproduction\n\n","\n\n * History of malignancy (other than MM) unless all treatment of that malignancy was completed at least 2 years before consent and the participant has no evidence of disease further exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or breast, or other non-invasive lesion, that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence within 3 years\n * Exhibits clinical signs of meningeal involvement of MM\n * Either of the following: 1. Chronic obstructive pulmonary disease with a forced expiratory volume in 1 second (FEV1) is less than (<) 50 % of predicted normal\n    2. Moderate or severe persistent asthma, or a history of asthma within the last 2 years, or currently has uncontrolled asthma of any classification\n   \n   \n * Any of the following: 1. Known to be seropositive for human immunodeficiency virus;\n    2. Known to be seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen [HBsAg]). Participants with resolved infection (participants who are positive for antibodies to hepatitis B core antigen [antiHBc] and/or antibodies to hepatitis B surface antigen [antiHBs]) must be screened using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) DNA levels . Those who are polymerase chain reaction (PCR) positive will be excluded\n   \n   \n * Known to be seropositive for hepatitis C (Anti-HCV antibody positive or HCV-RNA quantitation positive) except in the setting of a sustained virologic response [SVR], defined as aviremia at least 12 weeks after completion of antiviral therapy",{"$nulls":4},"Actual","2018-01-26","Actual","Anticipated","2022-03-31","Anticipated","2018-07-01","2018-01-22","2018-01-22","2018-07-06","No",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Non-Randomized","18 Years",null,"All",null,"No",null,null,"URL: http://pam.sylogent.com/cr/CR108435 [http://pam.sylogent.com/cr/CR108435] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To learn how to participate in this trial please click here.",null,"Yes","No",{"$nulls":17},"2017-004203-41|54767414MMY2040","EudraCT Number|Janssen Research & Development, LLC","D-VMP and D-Rd Cohort: Overall Response Rate (ORR)|D-VRd Cohort: Very Good Partial Response (VGPR) or Better Rate","The ORR is defined as the percentage of participants who achieve partial response (PR) or better according to international myeloma working group (IMWG) criteria, during or after study treatment for D-VMP and D-Rd cohorts. IMWG criteria for PR: greater than or equal to (>=) 50 percent (%) reduction of serum M-protein and reduction in 24-hour urinary M-protein by >=90% or to less than (<) 200 mg/24 hours, If the serum and urine M-protein are not measurable, a decrease of >=50% in the difference between involved and uninvolved free light chain (FLC) levels is required in place of the M-protein criteria, If serum and urine M-protein are not measurable, and serum free light assay is also not measurable, >=50% reduction in bone marrow plasma cells (PCs) is required in place of M-protein, provided baseline bone marrow plasma cell percentage was >=30%. In addition to the above criteria, if present at baseline, a >=50% reduction in the size of soft tissue plasmacytomas is also required.|The VGPR or better rate, defined as the percentage of participants achieving VGPR or better according IMWG criteria during or after the study treatment in Daratumumab + Bortezomib + Lenalidomide + Dexamethasone (D-VRd) cohort. IMWG criteria for VGPR: Serum and urine M-component detectable by immunofixation but not on electrophoresis, or >= 90 percent (%) reduction in serum M-protein plus urine M-protein <100 milligram per 24 hours (mg/24 hours).","At least 6 months after the last participant enrolled (approximately 1.5 years)","Maximum Observed Serum Concentrations (Cmax) of Daratumumab|Minimum Observed Serum Concentrations (Cmin) of Daratumumab|Percentage of Participants with Infusion-Related Reactions (IRR)|D-VMP and D-Rd Cohort: Very Good Partial Response (VGPR) or Better Rate|D-VRd Cohort: Overall Response Rate (ORR)|Complete Response or Better Rate|Duration of Response (DOR)|Number of Participants with Anti-Drug Antibodies Against Daratumumab or Recombinant Human Hyaluronidase (rHuPH20)|D-VMP and D-Rd Cohorts: Percentage of Participants who are Minimal Residual Disease (MRD) Negative","Cmax is defined as maximum concentration observed following daratumumab administration.|Cmin is defined as the minimum concentration observed immediately before daratumumab administration.|The Percentage of Participants with infusion reactions will be reported.|The VGPR or better rate, defined as the percentage of participants achieving VGPR or better rate according IMWG criteria during or after the study treatment for Daratumumab + Bortezomib + Melphalan + Prednisone (D-VMP) and Daratumumab + Lenalidomide + Dexamethasone (D-Rd) cohorts. IMWG criteria for VGPR: Serum and urine M-component detectable by immunofixation but not on electrophoresis, or greater than equal to (>=) 90 percent (%) reduction in serum M-protein plus urine M-protein <100 milligram (mg)/24 hours.|The ORR is defined as the proportion of participants who achieve partial response (PR) or better according to IMWG criteria, during or after study treatment for D-VRd cohort. IMWG criteria for PR: greater than or equal to (>=) 50 percent (%) reduction of serum M-protein and reduction in 24-hour urinary M-protein by >=90% or to less than (<) 200 mg/24 hours, If the serum and urine M-protein are not measurable, a decrease of >=50% in the difference between involved and uninvolved free light chain (FLC) levels is required in place of the M-protein criteria, If serum and urine M-protein are not measurable, and serum free light assay is also not measurable, >=50% reduction in bone marrow plasma cells (PCs) is required in place of M-protein, provided baseline bone marrow plasma cell percentage was >=30%. In addition to the above criteria, if present at baseline, a >=50% reduction in the size of soft tissue plasmacytomas is also required.|Complete response is based on serum M-Protein assessments. IMWG criteria for CR: Negative immunofixation on the serum and urine, and disappearance of any soft tissue plasmacytomas, and <5% PCs in bone marrow. Stringent complete response (sCR): CR plus normal FLC ratio, and absence of clonal PCs by immunohistochemistry, immunofluorescence or 2- to 4 color flow cytometry.|Duration of response is defined as the time from the date of initial documented response (PR or better for D-VMP and D-Rd cohorts, or VGPR or better for D-VRd cohort) to the date of first documented evidence of progressive disease or death due to progressive disease (PD).|Participants with anti-drug antibodies against daratumumab or rHuPH20 will be analyzed.|Percentage of participants who are MRD negative will be assessed for D-VMP and D-Rd cohorts. MRD negative is defined as less than (<) 0.01% abnormal population counts to total event counts when measured by flow.","D-VRd: Day 4 of Cycles 1 and 4 and post treatment 30 Days and at week 8; D-VMP: Day 4 of Cycles 1 and 2 and post treatment 30 Days and at week 8; D-Rd: Day 4 of Cycles 1 and 2 and post treatment 30 Days and at week 8|D-VRd: predose on Day 1 of Cycles 1, 3, and 4; D-VMP: predose on Day 1 of Cycles 1, 2, 3, 6 and 9 and D-Rd: predose on Day 1 of Cycles 1, 3, 6, 9 and 12|At least 6 months after last participant enrolled (approximately 1.5 years)|At least 6 months after the last participant enrolled (approximately 1.5 years)|At least 6 months after the last participant enrolled (approximately 1.5 years) and 18 months after the last participant enrolled (approximately 2.5 years)|Up to 8 weeks after the last dose of study drug (approximately 1 year)","JNJ.CT@sylogent.com","Study Contact","844-434-4210","Fortaleza, Brazil, 60430-230 Liga Norte Riograndense Contra O CancerNatal, Brazil, 59075-740 Centro De Pesquisa Do Instituto Do CÃ¢ncer- Hospital SÃ£o Vicente De PauloPasso Fundo, Brazil, 99010-090 Hospital MÃ£e De Deus CenterPorto Alegre, Brazil, 90470-340 Instituto Nacional Do Cancer - IncaRio De Janeiro, Brazil, 20230-130 Universidade Federal De Sao PauloSao Paulo, Brazil, 04037-002 Hospital Do Servidor Publico Estadual - IamspeSao Paulo, Brazil Clinica Sao GermanoSÃ£o Paulo, Brazil, 01455-010|Brno, Czechia, 625 00 Fakultni Nemocnice Hradec KraloveHradec Kralove, Czechia, 500 05 Fakultni Nemocnice OstravaOstrava, Czechia, 70852 Vseobecna Fakultni Nemocnice V Praze - I. Interni Klinika - Klinika HematologiePraha 2, Czechia, 128 08|Nantes Cedex 1, France, 44093 Chu De Bordeaux - HÃ´pital Haut-LÃ©vÃªquePessac Cedex, France, 33604 Centre Hospitalier Lyon-SudPierre-BÃ©nite, France, 69495 Chu BretonneauTours Cedex 9, France, 37044 Chu Nancy BraboisVandoeuvre Les Nancy, France, 54511|Chemnitz, Germany, 09113 Asklepios Klinik AltonaHamburg, Germany, 22763 Universitaetsklinikum HeidelbergHeidelberg, Germany, 69120 Universitaetsklinikum Tuebingen Der Eberhard-Karls-Universitaet, Abteilung Fuer Innere Medizin Ii,TÃ¼bingen, Germany, 72076|Haifa, Israel, 31096 Carmel Medical CenterHaifa, Israel, 3436212 Hadassah Medical CenterJerusalem, Israel, 9112001 Galilee Medical CenterNahariya, Israel, 22100 Sheba Medical CenterRamat Gan, Israel, 52621 Tel-Aviv Sourasky Medical CenterTel-Aviv, Israel, 64239|Kanazawa, Japan, 920-8641 Matsuyama Red Cross HospitalMatsuyama, Japan, 790-8524 Nagoya City University HospitalNagoya, Japan, 467-8602 Japanese Red Cross Central Medical CenterShibuya, Japan, 150-8935 Korea, Republic Of Keimyung University Dongsan HospitalDaegu, Korea, Republic Of, 700-712 Yeungnam University Medical CenterDaegu, Korea, Republic Of, 705-703 Chungnam National University HospitalDaejeon, Korea, Republic Of, 35015 Chonnam National University Hwasun HospitalHwasun Gun, Korea, Republic Of, 58128 Seoul National University Bundang HospitalSeongnam-Si, Korea, Republic Of, 13620 Korea Cancer Center HospitalSeoul, Korea, Republic Of, 01812 Seoul National University HospitalSeoul, Korea, Republic Of, 03080|Badalona, Spain, 08916 Hosp. Univ. Vall D HebronBarcelona, Spain, 08035 Hosp. Clinic I Provincial De BarcelonaBarcelona, Spain, 08036 Inst. Cat. Doncologia-H Duran I ReynalsBarcelona, Spain, 08908 Hosp. Gral. Univ. Gregorio MaranonMadrid, Spain, 28007 Clinica Univ. De NavarraMadrid, Spain, 28027 Hosp. Univ. Ramon Y CajalMadrid, Spain, 28034 Hosp. Univ. 12 De OctubreMadrid, Spain, 28041 Hosp. Son LlatzerMallorca, Spain, 07198 Clinica Univ. De NavarraPamplona, Spain, 31008 Hosp. Clinico Univ. De SalamancaSalamanca, Spain, 37007 Hosp. Univ. Dr. PesetValencia, Spain, 46017|Birmingham, United Kingdom, B9 5Ss Royal Bournemouth HospitalBournemouth, United Kingdom, Bh7 7Dw Kent And Canterbury HospitalCanterbury, United Kingdom, Ct1 3Ng Manchester Royal InfirmaryManchester, United Kingdom, M13 9Wl Derriford HospitalPlymouth, United Kingdom, Pl6 8Dh Royal Stoke University HospitalStoke On Trent, United Kingdom, St4 6Qg|Farmington, Connecticut, United States, 06030 Cancer Center Of Central Connecticut - SouthingtonSouthington, Connecticut, United States, 06489-3237|Jacksonville, Florida, United States, 32224 Watson Clinic LlpLakeland, Florida, United States, 33805 Uf Health Cancer Center At Orlando HealthOrlando, Florida, United States, 32806|Iowa City, Iowa, United States, 52242|Baltimore, Maryland, United States, 21201|Detroit, Michigan, United States, 48201 Providence Cancer CenterSouthfield, Michigan, United States, 48075|Billings, Montana, United States, 59101|Lincoln, Nebraska, United States, 68506 Southeast Nebraska Cancer CenterLincoln, Nebraska, United States, 68510 Nebraska Cancer SpecialistsOmaha, Nebraska, United States, 68130 University Of Nebraska Medical CenterOmaha, Nebraska, United States, 68198|Ridgewood, New Jersey, United States, 07450|Farmington, New|East Hills, New York, United States, 11548 Queens Medical Associates, PcFresh Meadows, New York, United States, 11366 Northwell HealthLake Success, New York, United States, 11042 Nyu WinthropMineola, New York, United States, 11501 Mt. Sinai School Of MedicineNew York, New York, United States, 10029|Chapel Hill, North Carolina, United States, 27599 Wake Forest University Baptist Medical Center (Wfubmc) - Comprehensive Cancer CenterWinston-Salem, North Carolina, United States, 27157|Spartanburg, South Carolina, United States, 29303|Sioux Falls, South Dakota, United States, 57105|Salt Lake City, Utah, United States, 84121|Charlottesville, Virginia, United States, 22903|Seattle, Washington, United States, 98101","Connecticut|Florida|Iowa|Maryland|Michigan|Montana|Nebraska|New Jersey|New Mexico|New York|North Carolina|South Carolina|South Dakota|Utah|Virginia|Washington","Brazil|Czechia|France|Germany|Israel|Japan|Spain|United Kingdom|United States","Instituto Do Cancer Do Ceara|Fakultni Nemocnice Brno|Chu De Nantes HÃ´tel-Dieu|Klinikum Chemnitz Ggmbh|Rambam Medical Center|Kanazawa University Hospital|Hosp. Univ. Germans Trias I Pujol|Heart Of England Nhs Foundation Trust|University Of Connecticut|Mayo Clinic In Florida|University Of Iowa Hospitals & Clinics|University Of Maryland|Karmonos Cancer Institute|Billings Clinic|Nebraska Hematology And Oncology|The Valley Hospital|San Juan Oncology Associates|St Francis Hospital|University Of North Carolina|Gibbs Cancer Center|Avera Medical Group - Oncology & Hematology|Utah Cancer Specialists|University Of Virginia Cancer Center - Emily Couric Clinical Cancer Center - Women's Oncology Clini|Virginia Mason Medical Center",{"$nulls":3},"Janssen Research & Development, LLC Clinical Trial","2018-07-06","2020-05-25T16:38:52.379","2020-05-26T17:10:42.972","NCT03412565"]
["5ecbf49cfeab101b15530993","NCT03412565","2018-09-14","Johnson & Johnson","JNJ","Recruiting","A Study to Evaluate Subcutaneous Daratumumab in Combination With Standard Multiple Myeloma Treatment Regimens","Daratumumab|Bortezomib|Lenalidomide|Dexamethasone|Melphalan|Prednisone","CD38 Inhibitor|Proteasome Inhibitor|Angiogenesis Inhibitor|GR Agonist|GR Agonist|Immunosuppressive","No",null,"No",null,"Phase 2",3,180,"Anticipated","2018-04-26","2019-09-27","RR","Response Rate",{"$nulls":3},"The purpose of this study is to evaluate the clinical benefit of subcutaneous (SC) daratumumab administered in combination with standard multiple myeloma (MM) regimens in participants with MM as measured by overall response rate (ORR) or very good partial response (VGPR) or better rate.","The hypothesis is that the addition of daratumumab administered SC to standard MM regimens will improve responses compared to response data observed in completed phase 3 studies without daratumumab. Disease evaluations will include measurements of myeloma proteins, bone marrow examinations, skeletal surveys, assessment of extramedullary plasmacytomas, and measurements of serum calcium corrected for albumin. Safety will be measured by adverse events, laboratory test results, electrocardiogram (ECGs), vital sign measurements, physical examination findings, SC injection-site assessments, and assessment of Eastern Cooperative Oncology Group (ECOG) performance status score. Study will consist of 3 phases (screening, treatment and follow-up) and duration of study is approximately 3 years.","A Multicenter Phase 2 Study to Evaluate Subcutaneous Daratumumab in Combination With Standard Multiple Myeloma Treatment Regimens","CR108435","Multiple Myeloma","Multiple Myeloma","Oncology Hematological","Oncology","Experimental","Daratumumab(D)+Bortezomib+Lenalidomide+Dexamethasone (D-VRd)|D + Bortezomib + Melphalan + Prednisone (D-VMP)|Daratumumab + Lenalidomide + Dexamethasone (D-Rd)","Participants will receive daratumumab 1800 milligram (mg) by subcutaneous (SC) injection on Days 1, 8 and 15 of Cycles 1 to 3 (each cycle of 21 days) and on Day 1 of Cycle 4; bortezomib 1.3 milligram per square meter (mg/m^2) SC injection on Days 1, 4, 8 and 11 of Cycles 1 to 4; lenalidomide 25 mg orally on Day 1 through Day 14 of Cycles 1 to 4 and dexamethasone 20 mg orally or intravenously on Days 1, 2 ,8, 9, 15 and 16 of Cycle 1 to 4.|Participants will receive daratumumab 1800 mg by SC injection on Days 1, 8, 15, 22, 29 and 36 of Cycle 1 then on Days 1 and 22 in Cycles 2 to 9 and Day 1 of Cycle 10 and thereafter until documented progression of disease, unacceptable toxicity, or end of study; bortezomib 1.3 mg/m^2 SC injection on Day 1, 4, 8, 11, 22, 25, 29 and 32 of Cycle 1 and on Days 1, 8, 22 and 29 of Cycles 2 to 9; melphalan 9 mg/m^2 orally on Day 1 through Day 4 of Cycles 1 to 9; prednisone 60 mg/m^2 orally on Days 1 to 4 of cycles 1 to 9.|Participants will receive daratumumab 1800 mg by SC injection on Days 1, 8, 15 and 22 of Cycles 1 and 2 then on Day 1 and 15 of Cycles 3 to 6 and on Day 1 of Cycle 7 and thereafter until documented progression of disease, unacceptable toxicity, or end of study; lenalidomide 25 mg orally on Day 1 through Day 21 of each cycle until documented progression of disease, unacceptable toxicity, or end of study and dexamethasone 40 mg orally or intravenously weekly until documented progression of disease, unacceptable toxicity, or end of study.","Drug","Daratumumab|Bortezomib|Lenalidomide|Dexamethasone|Melphalan|Prednisone","Daratumumab will be administered at a dose of 1800 mg by SC injection in Cycles 1 to 4 in D-VRd cohort and until documented progression of disease, unacceptable toxicity, or end of study for D-VMP and D-Rd cohorts.|Bortezomib will be administered as 1.3 mg/m^2 SC injection in Cycles 1 to 4 in D-VRd cohort and in Cycles 1 to 9 in D-VMP cohort.|Lenalidomide will be administered as 25 mg capsule orally in Cycles 1 to 4 in D-VRd cohort and in all Cycles until documented progression of disease, unacceptable toxicity, or end of study in D-Rd cohort.|Dexamethasone will be administered as 20 mg orally or intravenously in Cycles 1 to 4 in D-VRd cohort; 40 mg orally or intravenously in all cycles and thereafter until documented progression of disease, unacceptable toxicity, or end of study in D-Rd cohort.|Melphalan will be administered as 9 mg/m^2 orally in Cycles 1 to 9.|Prednisone will be administered as 60 mg/m^2 orally in cycles 1 to 9.",null,"Daratumumab(D)+Bortezomib+Lenalidomide+Dexamethasone (D-VRd)|D + Bortezomib + Melphalan + Prednisone (D-VMP)|Daratumumab + Lenalidomide + Dexamethasone (D-Rd)","\n\n * Multiple myeloma diagnosed according to the International Myeloma Working Group (IMWG) diagnostic criteria\n * Measurable, secretory disease as defined by any of the following: 1. Serum monoclonal paraprotein (M-protein) level greater than or equal to (>=) 1.0 gram per deciliter (g/dL); or\n    2. Urine M-protein level >= 200 milligram per 24 hours (mg/24 hours); or\n    3. Light chain multiple myeloma (MM), for participants without measurable disease in the serum or urine: serum Immunoglobulin (Ig) free light chain (FLC) >= 10 mg/dL and abnormal FLC ratio\n   \n   \n * Meets one of the sets of the following criteria: 1. For Daratumumab + bortezomib + lenalidomide + dexamethasone (D-VRd) and Daratumumab + bortezomib + melphalan + prednisone + dexamethasone (D-VMP) regimen: newly diagnosed myeloma\n    2. For Daratumumab + lenalidomide + dexamethasone (D-Rd) regimen: relapsed or refractory disease\n   \n   \n * Eastern Cooperative Oncology Group (ECOG) Performance Status grade of 0, 1, or 2\n * During the study, and for 3 months after receiving the last dose of daratumumab, a woman must agree not to donate eggs (ova, oocytes) and men must agree not to donate sperm for the purposes of assisted reproduction\n\n","\n\n * History of malignancy (other than MM) unless all treatment of that malignancy was completed at least 2 years before consent and the participant has no evidence of disease further exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or breast, or other non-invasive lesion, that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence within 3 years\n * Exhibits clinical signs of meningeal involvement of MM\n * Either of the following: 1. Chronic obstructive pulmonary disease with a forced expiratory volume in 1 second (FEV1) is less than (<) 50 % of predicted normal\n    2. Moderate or severe persistent asthma, or a history of asthma within the last 2 years, or currently has uncontrolled asthma of any classification\n   \n   \n * Any of the following: 1. Known to be seropositive for human immunodeficiency virus;\n    2. Known to be seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen [HBsAg]). Participants with resolved infection (participants who are positive for antibodies to hepatitis B core antigen [antiHBc] and/or antibodies to hepatitis B surface antigen [antiHBs]) must be screened using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) DNA levels . Those who are polymerase chain reaction (PCR) positive will be excluded\n   \n   \n * Known to be seropositive for hepatitis C (Anti-HCV antibody positive or HCV-RNA quantitation positive) except in the setting of a sustained virologic response [SVR], defined as aviremia at least 12 weeks after completion of antiviral therapy",{"$nulls":4},"Actual","2018-01-26","Actual","Anticipated","2022-03-31","Anticipated","2018-09-01","2018-01-22","2018-01-22","2018-09-13","No",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Non-Randomized","18 Years",null,"All",null,"No",null,null,"URL: http://pam.sylogent.com/cr/CR108435 [http://pam.sylogent.com/cr/CR108435] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To learn how to participate in this trial please click here.",null,"Yes","No",{"$nulls":17},"2017-004203-41|54767414MMY2040","EudraCT Number|Janssen Research & Development, LLC","D-VMP and D-Rd Cohort: Overall Response Rate (ORR)|D-VRd Cohort: Very Good Partial Response (VGPR) or Better Rate","The ORR is defined as the percentage of participants who achieve partial response (PR) or better according to international myeloma working group (IMWG) criteria, during or after study treatment for D-VMP and D-Rd cohorts. IMWG criteria for PR: greater than or equal to (>=) 50 percent (%) reduction of serum M-protein and reduction in 24-hour urinary M-protein by >=90% or to less than (<) 200 mg/24 hours, If the serum and urine M-protein are not measurable, a decrease of >=50% in the difference between involved and uninvolved free light chain (FLC) levels is required in place of the M-protein criteria, If serum and urine M-protein are not measurable, and serum free light assay is also not measurable, >=50% reduction in bone marrow plasma cells (PCs) is required in place of M-protein, provided baseline bone marrow plasma cell percentage was >=30%. In addition to the above criteria, if present at baseline, a >=50% reduction in the size of soft tissue plasmacytomas is also required.|The VGPR or better rate, defined as the percentage of participants achieving VGPR or better according IMWG criteria during or after the study treatment in Daratumumab + Bortezomib + Lenalidomide + Dexamethasone (D-VRd) cohort. IMWG criteria for VGPR: Serum and urine M-component detectable by immunofixation but not on electrophoresis, or >= 90 percent (%) reduction in serum M-protein plus urine M-protein <100 milligram per 24 hours (mg/24 hours).","At least 6 months after the last participant enrolled (approximately 1.5 years)","Maximum Observed Serum Concentrations (Cmax) of Daratumumab|Minimum Observed Serum Concentrations (Cmin) of Daratumumab|Percentage of Participants with Infusion-Related Reactions (IRR)|D-VMP and D-Rd Cohort: Very Good Partial Response (VGPR) or Better Rate|D-VRd Cohort: Overall Response Rate (ORR)|Complete Response or Better Rate|Duration of Response (DOR)|Number of Participants with Anti-Drug Antibodies Against Daratumumab or Recombinant Human Hyaluronidase (rHuPH20)|D-VMP and D-Rd Cohorts: Percentage of Participants who are Minimal Residual Disease (MRD) Negative","Cmax is defined as maximum concentration observed following daratumumab administration.|Cmin is defined as the minimum concentration observed immediately before daratumumab administration.|The Percentage of Participants with infusion reactions will be reported.|The VGPR or better rate, defined as the percentage of participants achieving VGPR or better rate according IMWG criteria during or after the study treatment for Daratumumab + Bortezomib + Melphalan + Prednisone (D-VMP) and Daratumumab + Lenalidomide + Dexamethasone (D-Rd) cohorts. IMWG criteria for VGPR: Serum and urine M-component detectable by immunofixation but not on electrophoresis, or greater than equal to (>=) 90 percent (%) reduction in serum M-protein plus urine M-protein <100 milligram (mg)/24 hours.|The ORR is defined as the proportion of participants who achieve partial response (PR) or better according to IMWG criteria, during or after study treatment for D-VRd cohort. IMWG criteria for PR: greater than or equal to (>=) 50 percent (%) reduction of serum M-protein and reduction in 24-hour urinary M-protein by >=90% or to less than (<) 200 mg/24 hours, If the serum and urine M-protein are not measurable, a decrease of >=50% in the difference between involved and uninvolved free light chain (FLC) levels is required in place of the M-protein criteria, If serum and urine M-protein are not measurable, and serum free light assay is also not measurable, >=50% reduction in bone marrow plasma cells (PCs) is required in place of M-protein, provided baseline bone marrow plasma cell percentage was >=30%. In addition to the above criteria, if present at baseline, a >=50% reduction in the size of soft tissue plasmacytomas is also required.|Complete response is based on serum M-Protein assessments. IMWG criteria for CR: Negative immunofixation on the serum and urine, and disappearance of any soft tissue plasmacytomas, and <5% PCs in bone marrow. Stringent complete response (sCR): CR plus normal FLC ratio, and absence of clonal PCs by immunohistochemistry, immunofluorescence or 2- to 4 color flow cytometry.|Duration of response is defined as the time from the date of initial documented response (PR or better for D-VMP and D-Rd cohorts, or VGPR or better for D-VRd cohort) to the date of first documented evidence of progressive disease or death due to progressive disease (PD).|Participants with anti-drug antibodies against daratumumab or rHuPH20 will be analyzed.|Percentage of participants who are MRD negative will be assessed for D-VMP and D-Rd cohorts. MRD negative is defined as less than (<) 0.01% abnormal population counts to total event counts when measured by flow.","D-VRd: Day 4 of Cycles 1 and 4 and post treatment 30 Days and at week 8; D-VMP: Day 4 of Cycles 1 and 2 and post treatment 30 Days and at week 8; D-Rd: Day 4 of Cycles 1 and 2 and post treatment 30 Days and at week 8|D-VRd: predose on Day 1 of Cycles 1, 3, and 4; D-VMP: predose on Day 1 of Cycles 1, 2, 3, 6 and 9 and D-Rd: predose on Day 1 of Cycles 1, 3, 6, 9 and 12|At least 6 months after last participant enrolled (approximately 1.5 years)|At least 6 months after the last participant enrolled (approximately 1.5 years)|At least 6 months after the last participant enrolled (approximately 1.5 years) and 18 months after the last participant enrolled (approximately 2.5 years)|Up to 8 weeks after the last dose of study drug (approximately 1 year)","JNJ.CT@sylogent.com","Study Contact","844-434-4210","Fortaleza, Brazil, 60430-230 Liga Norte Riograndense Contra O CancerNatal, Brazil, 59075-740 Centro De Pesquisa Do Instituto Do CÃ¢ncer- Hospital SÃ£o Vicente De PauloPasso Fundo, Brazil, 99010-090 Hospital MÃ£e De Deus CenterPorto Alegre, Brazil, 90470-340 Instituto Nacional Do Cancer - IncaRio De Janeiro, Brazil, 20230-130 Universidade Federal De Sao PauloSao Paulo, Brazil, 04037-002 Hospital Do Servidor Publico Estadual - IamspeSao Paulo, Brazil Clinica Sao GermanoSÃ£o Paulo, Brazil, 01455-010|Brno, Czechia, 625 00 Fakultni Nemocnice Hradec KraloveHradec Kralove, Czechia, 500 05 Fakultni Nemocnice OstravaOstrava, Czechia, 70852 Vseobecna Fakultni Nemocnice V Praze - I. Interni Klinika - Klinika HematologiePraha 2, Czechia, 128 08|Nantes Cedex 1, France, 44093 Chu De Bordeaux - HÃ´pital Haut-LÃ©vÃªquePessac Cedex, France, 33604 Centre Hospitalier Lyon-SudPierre-BÃ©nite, France, 69495 Chu BretonneauTours Cedex 9, France, 37044 Chu Nancy BraboisVandoeuvre Les Nancy, France, 54511|Haifa, Israel, 31096 Carmel Medical CenterHaifa, Israel, 3436212 Hadassah Medical CenterJerusalem, Israel, 9112001 Galilee Medical CenterNahariya, Israel, 22100 Sheba Medical CenterRamat Gan, Israel, 52621 Tel-Aviv Sourasky Medical CenterTel-Aviv, Israel, 64239|Kanazawa, Japan, 920-8641 Matsuyama Red Cross HospitalMatsuyama, Japan, 790-8524 Nagoya City University HospitalNagoya, Japan, 467-8602 Japanese Red Cross Central Medical CenterShibuya, Japan, 150-8935 Korea, Republic Of Keimyung University Dongsan HospitalDaegu, Korea, Republic Of, 700-712 Yeungnam University Medical CenterDaegu, Korea, Republic Of, 705-703 Chungnam National University HospitalDaejeon, Korea, Republic Of, 35015 Chonnam National University Hwasun HospitalHwasun Gun, Korea, Republic Of, 58128 Seoul National University Bundang HospitalSeongnam-Si, Korea, Republic Of, 13620 Korea Cancer Center HospitalSeoul, Korea, Republic Of, 01812 Seoul National University HospitalSeoul, Korea, Republic Of, 03080|Badalona, Spain, 08916 Hosp. Univ. Vall D HebronBarcelona, Spain, 08035 Hosp. Clinic I Provincial De BarcelonaBarcelona, Spain, 08036 Inst. Cat. Doncologia-H Duran I ReynalsBarcelona, Spain, 08908 Hosp. Gral. Univ. Gregorio MaranonMadrid, Spain, 28007 Clinica Univ. De NavarraMadrid, Spain, 28027 Hosp. Univ. Ramon Y CajalMadrid, Spain, 28034 Hosp. Univ. 12 De OctubreMadrid, Spain, 28041 Hosp. Son LlatzerMallorca, Spain, 07198 Clinica Univ. De NavarraPamplona, Spain, 31008 Hosp. Clinico Univ. De SalamancaSalamanca, Spain, 37007 Hosp. Univ. Dr. PesetValencia, Spain, 46017|Birmingham, United Kingdom, B9 5Ss Royal Bournemouth HospitalBournemouth, United Kingdom, Bh7 7Dw Kent And Canterbury HospitalCanterbury, United Kingdom, Ct1 3Ng Manchester Royal InfirmaryManchester, United Kingdom, M13 9Wl Derriford HospitalPlymouth, United Kingdom, Pl6 8Dh Royal Stoke University HospitalStoke On Trent, United Kingdom, St4 6Qg|Farmington, Connecticut, United States, 06030 Cancer Center Of Central Connecticut - SouthingtonSouthington, Connecticut, United States, 06489-3237|Jacksonville, Florida, United States, 32224 Watson Clinic LlpLakeland, Florida, United States, 33805 Uf Health Cancer Center At Orlando HealthOrlando, Florida, United States, 32806|Iowa City, Iowa, United States, 52242|Baltimore, Maryland, United States, 21201|Detroit, Michigan, United States, 48201 Providence Cancer CenterSouthfield, Michigan, United States, 48075|Billings, Montana, United States, 59101|Lincoln, Nebraska, United States, 68506 Southeast Nebraska Cancer CenterLincoln, Nebraska, United States, 68510 Nebraska Cancer SpecialistsOmaha, Nebraska, United States, 68130 University Of Nebraska Medical CenterOmaha, Nebraska, United States, 68198|Ridgewood, New Jersey, United States, 07450|Farmington, New|East Hills, New York, United States, 11548 Queens Medical Associates, PcFresh Meadows, New York, United States, 11366 Northwell HealthLake Success, New York, United States, 11042 Nyu WinthropMineola, New York, United States, 11501 Mt. Sinai School Of MedicineNew York, New York, United States, 10029|Chapel Hill, North Carolina, United States, 27599 Wake Forest University Baptist Medical Center (Wfubmc) - Comprehensive Cancer CenterWinston-Salem, North Carolina, United States, 27157|Spartanburg, South Carolina, United States, 29303|Sioux Falls, South Dakota, United States, 57105|Salt Lake City, Utah, United States, 84121|Charlottesville, Virginia, United States, 22903|Seattle, Washington, United States, 98101","Connecticut|Florida|Iowa|Maryland|Michigan|Montana|Nebraska|New Jersey|New Mexico|New York|North Carolina|South Carolina|South Dakota|Utah|Virginia|Washington","Brazil|Czechia|France|Israel|Japan|Spain|United Kingdom|United States","Instituto Do Cancer Do Ceara|Fakultni Nemocnice Brno|Chu De Nantes HÃ´tel-Dieu|Rambam Medical Center|Kanazawa University Hospital|Hosp. Univ. Germans Trias I Pujol|Heart Of England Nhs Foundation Trust|University Of Connecticut|Mayo Clinic In Florida|University Of Iowa Hospitals & Clinics|University Of Maryland|Karmonos Cancer Institute|Billings Clinic|Nebraska Hematology And Oncology|The Valley Hospital|San Juan Oncology Associates|St Francis Hospital|University Of North Carolina|Gibbs Cancer Center|Avera Medical Group - Oncology & Hematology|Utah Cancer Specialists|University Of Virginia Cancer Center - Emily Couric Clinical Cancer Center - Women's Oncology Clini|Virginia Mason Medical Center",{"$nulls":3},"Janssen Research & Development, LLC Clinical Trial","2018-09-13","2020-05-25T16:38:52.567","2020-05-26T17:10:42.972","NCT03412565"]
["5ecbf49cfe30261b1a048365","NCT03412565","2018-12-07","Johnson & Johnson","JNJ","Active, not recruiting","A Study to Evaluate Subcutaneous Daratumumab in Combination With Standard Multiple Myeloma Treatment Regimens","Daratumumab|Bortezomib|Lenalidomide|Dexamethasone|Melphalan|Prednisone|Carfilzomib","CD38 Inhibitor|Proteasome Inhibitor|Angiogenesis Inhibitor|GR Agonist|GR Agonist|Immunosuppressive","No",null,"No",null,"Phase 2",4,199,"Actual","2018-04-26","2019-09-27","RR","Response Rate",{"$nulls":3},"The purpose of this study is to evaluate the clinical benefit of subcutaneous (SC) daratumumab administered in combination with standard multiple myeloma (MM) regimens in participants with MM as measured by overall response rate (ORR) or very good partial response (VGPR) or better rate.","The hypothesis is that the addition of daratumumab administered SC to standard MM regimens will improve responses compared to response data observed in completed phase 3 studies without daratumumab. Disease evaluations will include measurements of myeloma proteins, bone marrow examinations, skeletal surveys, assessment of extramedullary plasmacytomas, and measurements of serum calcium corrected for albumin. Safety will be measured by adverse events, laboratory test results, electrocardiogram (ECGs), vital sign measurements, physical examination findings, SC injection-site assessments, and assessment of Eastern Cooperative Oncology Group (ECOG) performance status score. Study will consist of 3 phases (screening, treatment and follow-up) and duration of study is approximately 3 years.","A Multicenter Phase 2 Study to Evaluate Subcutaneous Daratumumab in Combination With Standard Multiple Myeloma Treatment Regimens","CR108435","Multiple Myeloma","Multiple Myeloma","Oncology Hematological","Oncology","Experimental","Daratumumab(D)+Bortezomib+Lenalidomide+Dexamethasone (D-VRd)|D + Bortezomib + Melphalan + Prednisone (D-VMP)|Daratumumab + Lenalidomide + Dexamethasone (D-Rd)|Daratumumab + Carfilzomib + Dexamethasone (D-Kd)","Participants will receive daratumumab 1800 milligram (mg) by subcutaneous (SC) injection on Days 1, 8 and 15 of Cycles 1 to 3 (each cycle of 21 days) and on Day 1 of Cycle 4; bortezomib 1.3 milligram per square meter (mg/m^2) SC injection on Days 1, 4, 8 and 11 of Cycles 1 to 4; lenalidomide 25 mg orally on Day 1 through Day 14 of Cycles 1 to 4 and dexamethasone 20 mg orally or intravenously on Days 1, 2 ,8, 9, 15 and 16 of Cycle 1 to 4.|Participants will receive daratumumab 1800 mg by SC injection on Days 1, 8, 15, 22, 29 and 36 of Cycle 1 then on Days 1 and 22 in Cycles 2 to 9 and Day 1 of Cycle 10 and thereafter until documented progression of disease, unacceptable toxicity, or end of study; bortezomib 1.3 mg/m^2 SC injection on Day 1, 4, 8, 11, 22, 25, 29 and 32 of Cycle 1 and on Days 1, 8, 22 and 29 of Cycles 2 to 9; melphalan 9 mg/m^2 orally on Day 1 through Day 4 of Cycles 1 to 9; prednisone 60 mg/m^2 orally on Days 1 to 4 of cycles 1 to 9.|Participants will receive daratumumab 1800 mg by SC injection on Days 1, 8, 15 and 22 of Cycles 1 and 2 then on Day 1 and 15 of Cycles 3 to 6 and on Day 1 of Cycle 7 and thereafter until documented progression of disease, unacceptable toxicity, or end of study; lenalidomide 25 mg orally on Day 1 through Day 21 of each cycle until documented progression of disease, unacceptable toxicity, or end of study and dexamethasone 40 mg orally or intravenously weekly until documented progression of disease, unacceptable toxicity, or end of study.|Participants will receive daratumumab 1800 mg by SC injection on Days 1, 8, 15 and 22 of Cycles 1 and 2 (each cycle is of 28 days) then on Day 1 and 15 of Cycles 3 to 6 and on Day 1 of Cycle 7 and thereafter until documented progression of disease, unacceptable toxicity, or end of study; Carfilzomib 20 mg/m^2 intravenously (IV) on Day 1 of Cycle 1 only then 70 mg/m^2 IV on Days 8 and 15 of Cycle 1 and Days 1, 8 and 15 of Cycle 2 and thereafter until documented progression of disease, unacceptable toxicity, or end of study and dexamethasone 40 mg orally or IV weekly for Cycles 1-9 then on Days 1, 8, 15 of each cycle for Cycles 10 and thereafter until documented progression of disease, unacceptable toxicity, or end of study.","Drug","Daratumumab|Bortezomib|Lenalidomide|Dexamethasone|Melphalan|Prednisone|Carfilzomib","Daratumumab will be administered at a dose of 1800 mg by SC injection in Cycles 1 to 4 in D-VRd cohort and until documented progression of disease, unacceptable toxicity, or end of study for D-VMP, D-Rd and D-Kd cohorts.|Bortezomib will be administered as 1.3 mg/m^2 SC injection in Cycles 1 to 4 in D-VRd cohort and in Cycles 1 to 9 in D-VMP cohort.|Lenalidomide will be administered as 25 mg capsule orally in Cycles 1 to 4 in D-VRd cohort and in all Cycles until documented progression of disease, unacceptable toxicity, or end of study in D-Rd cohort.|Dexamethasone will be administered as 20 mg orally or intravenously in Cycles 1 to 4 in D-VRd cohort; 40 mg orally or intravenously in all cycles and thereafter until documented progression of disease, unacceptable toxicity, or end of study in D-Rd and D-Kd cohort.|Melphalan will be administered as 9 mg/m^2 orally in Cycles 1 to 9.|Prednisone will be administered as 60 mg/m^2 orally in cycles 1 to 9.|Carfilzomib will be administered as 20 mg/m^2 IV on Day 1 of Cycle 1 only then 70 mg/m^2 IV on Days 8 and 15 of Cycle 1 and Days 1, 8 and 15 of Cycle 2 and thereafter until documented progression of disease, unacceptable toxicity, or end of study in D-Kd cohort.",null,"Daratumumab(D)+Bortezomib+Lenalidomide+Dexamethasone (D-VRd)|D + Bortezomib + Melphalan + Prednisone (D-VMP)|Daratumumab + Lenalidomide + Dexamethasone (D-Rd)|Daratumumab + Carfilzomib + Dexamethasone (D-Kd)","\n\n * Multiple myeloma diagnosed according to the International Myeloma Working Group (IMWG) diagnostic criteria\n * Measurable, secretory disease as defined by any of the following: 1. Serum monoclonal paraprotein (M-protein) level greater than or equal to (>=) 1.0 gram per deciliter (g/dL); or\n    2. Urine M-protein level >= 200 milligram per 24 hours (mg/24 hours); or\n    3. Light chain multiple myeloma (MM), for participants without measurable disease in the serum or urine: serum Immunoglobulin (Ig) free light chain (FLC) >= 10 mg/dL and abnormal FLC ratio\n   \n   \n * Meets one of the sets of the following criteria: 1. For Daratumumab + bortezomib + lenalidomide + dexamethasone (D-VRd) and Daratumumab + bortezomib + melphalan + prednisone + dexamethasone (D-VMP) regimen: newly diagnosed myeloma\n    2. For Daratumumab + lenalidomide + dexamethasone (D-Rd) and Daratumumab + Carfilzomib + Dexamethasone (D-Kd) regimen: relapsed or refractory disease\n    3. D-Kd cohort: Participants must have received only 1 prior line of therapy for MM which included at least 2 consecutive cycles of lenalidomide therapy\n   \n   \n * Eastern Cooperative Oncology Group (ECOG) Performance Status grade of 0, 1, or 2\n * During the study, and for 3 months after receiving the last dose of daratumumab, a woman must agree not to donate eggs (ova, oocytes) and men must agree not to donate sperm for the purposes of assisted reproduction\n\n","\n\n * History of malignancy (other than MM) unless all treatment of that malignancy was completed at least 2 years before consent and the participant has no evidence of disease further exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or breast, or other non-invasive lesion, that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence within 3 years\n * Exhibits clinical signs of meningeal involvement of MM\n * Either of the following: 1. Chronic obstructive pulmonary disease with a forced expiratory volume in 1 second (FEV1) is less than (<) 50 percentage (%) of predicted normal\n    2. Moderate or severe persistent asthma, or a history of asthma within the last 2 years, or currently has uncontrolled asthma of any classification\n    3. For D-Kd cohort: Known infiltrative pulmonary disease or known pulmonary hypertension\n   \n   \n * Any of the following: 1. Known to be seropositive for human immunodeficiency virus;\n    2. Known to be seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen [HBsAg]). Participants with resolved infection (participants who are positive for antibodies to hepatitis B core antigen [antiHBc] and/or antibodies to hepatitis B surface antigen [antiHBs]) must be screened using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) DNA levels . Those who are polymerase chain reaction (PCR) positive will be excluded\n   \n   \n * Known to be seropositive for hepatitis C (Anti-HCV antibody positive or HCV-RNA quantitation positive) except in the setting of a sustained virologic response [SVR], defined as aviremia at least 12 weeks after completion of antiviral therapy\n * For D-Kd cohort only: Transthoracic echocardiogram showing left ventricular ejection fraction (LVEF) <40%; uncontrolled hypertension, defined as an average systolic blood pressure greater than (>)159 millimeters of mercury (mmHg) or diastolic >99 mmHg despite optimal treatment",{"$nulls":4},"Actual","2018-01-26","Actual","Anticipated","2021-02-01","Anticipated","2018-12-01","2018-01-22","2018-01-22","2018-12-06","No",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Non-Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"2017-004203-41|54767414MMY2040","EudraCT Number|Janssen Research & Development, LLC","D-VMP, D-Kd, and D-Rd Cohort: Overall Response Rate (ORR)|D-VRd Cohort: Very Good Partial Response (VGPR) or Better Rate","The ORR is defined as the percentage of participants who achieve partial response (PR) or better according to international myeloma working group (IMWG) criteria, during or after study treatment for D-VMP, D-Kd and D-Rd cohorts. IMWG criteria for PR: greater than or equal to (>=) 50 percent (%) reduction of serum M-protein and reduction in 24-hour urinary M-protein by >=90% or to less than (<) 200 mg/24 hours, If the serum and urine M-protein are not measurable, a decrease of >=50% in the difference between involved and uninvolved free light chain (FLC) levels is required in place of the M-protein criteria, If serum and urine M-protein are not measurable, and serum free light assay is also not measurable, >=50% reduction in bone marrow plasma cells (PCs) is required in place of M-protein, provided baseline bone marrow plasma cell percentage was >=30%. In addition to the above criteria, if present at baseline, a >=50% reduction in the size of soft tissue plasmacytomas is also required.|The VGPR or better rate, defined as the percentage of participants achieving VGPR or better according IMWG criteria during or after the study treatment in Daratumumab + Bortezomib + Lenalidomide + Dexamethasone (D-VRd) cohort. IMWG criteria for VGPR: Serum and urine M-component detectable by immunofixation but not on electrophoresis, or >= 90 percent (%) reduction in serum M-protein plus urine M-protein <100 milligram per 24 hours (mg/24 hours).","18 months after the last participant enrolled (approximately 2.5 years)","Maximum Observed Serum Concentrations (Cmax) of Daratumumab|Minimum Observed Serum Concentrations (Cmin) of Daratumumab|Percentage of Participants with Infusion-Related Reactions (IRR)|D-Kd, D-VMP, and D-Rd Cohort: Very Good Partial Response (VGPR) or Better Rate|D-VRd Cohort: Overall Response Rate (ORR)|Complete Response or Better Rate|Duration of Response (DOR)|Number of Participants with Anti-Drug Antibodies Against Daratumumab or Recombinant Human Hyaluronidase (rHuPH20)|D-Kd, D-VMP, and D-Rd Cohorts: Percentage of Participants who are Minimal Residual Disease (MRD) Negative","Cmax is defined as maximum concentration observed following daratumumab administration.|Cmin is defined as the minimum concentration observed immediately before daratumumab administration.|The Percentage of Participants with infusion reactions will be reported.|The VGPR or better rate, defined as the percentage of participants achieving VGPR or better rate according IMWG criteria during or after the study treatment for Daratumumab + Carfilzomib + Dexamethasone (D-Kd), Daratumumab + Bortezomib + Melphalan + Prednisone (D-VMP), and Daratumumab + Lenalidomide + Dexamethasone (D-Rd) cohorts. IMWG criteria for VGPR: Serum and urine M-component detectable by immunofixation but not on electrophoresis, or greater than equal to (>=) 90 percent (%) reduction in serum M-protein plus urine M-protein <100 milligram (mg)/24 hours.|The ORR is defined as the proportion of participants who achieve partial response (PR) or better according to IMWG criteria, during or after study treatment for D-VRd cohort. IMWG criteria for PR: greater than or equal to (>=) 50 percent (%) reduction of serum M-protein and reduction in 24-hour urinary M-protein by >=90% or to less than (<) 200 mg/24 hours, If the serum and urine M-protein are not measurable, a decrease of >=50% in the difference between involved and uninvolved free light chain (FLC) levels is required in place of the M-protein criteria, If serum and urine M-protein are not measurable, and serum free light assay is also not measurable, >=50% reduction in bone marrow plasma cells (PCs) is required in place of M-protein, provided baseline bone marrow plasma cell percentage was >=30%. In addition to the above criteria, if present at baseline, a >=50% reduction in the size of soft tissue plasmacytomas is also required.|Complete response is based on serum M-Protein assessments. IMWG criteria for CR: Negative immunofixation on the serum and urine, and disappearance of any soft tissue plasmacytomas, and <5% PCs in bone marrow. Stringent complete response (sCR): CR plus normal FLC ratio, and absence of clonal PCs by immunohistochemistry, immunofluorescence or 2- to 4 color flow cytometry.|Duration of response is defined as the time from the date of initial documented response (PR or better for D-Kd, D-VMP, D-Rd, and D-VRd cohorts) to the date of first documented evidence of progressive disease or death due to progressive disease (PD).|Participants with anti-drug antibodies against daratumumab or rHuPH20 will be analyzed.|Percentage of participants who are MRD negative will be assessed for D-Kd, D-VMP, and D-Rd cohorts. MRD negative is defined as less than (<) 0.01% abnormal population counts to total event counts when measured by flow.","D-VRd: Day 4 of Cycles 1 and 4 and post treatment 30 Days and at week 8; D-VMP and D-Rd: Day 4 of Cycles 1 and 2 and post treatment 30 Days and at week 8; D-Kd: Day 4 of Cycles 1 and 3 and post treatment 30 Days and at week 8|D-VRd: predose on Day 1 of Cycles 1, 3, and 4; D-VMP: predose on Day 1 of Cycles 1, 2, 3, 6 and 9; D-Rd: predose on Day 1 of Cycles 1, 3, 6, 9 and 12 and D-Kd: predose on Day 1 of Cycles 1, 3, 6, 9, and 12|18 months after the last participant enrolled (approximately 2.5 years)|Up to 8 weeks after the last dose of study drug (approximately 1 year)",{"$nulls":3},"Natal, Brazil, 59075-740 Centro De Pesquisa Do Instituto Do CÃ¢ncer- Hospital SÃ£o Vicente De PauloPasso Fundo, Brazil, 99010-090 Instituto Nacional Do Cancer - IncaRio De Janeiro, Brazil, 20230-130 Universidade Federal De Sao PauloSao Paulo, Brazil, 04037-002 Hospital Do Servidor Publico Estadual - IamspeSao Paulo, Brazil Clinica Sao GermanoSÃ£o Paulo, Brazil, 01455-010|Brno, Czechia, 625 00 Fakultni Nemocnice Hradec KraloveHradec Kralove, Czechia, 500 05 Fakultni Nemocnice OstravaOstrava, Czechia, 70852 Vseobecna Fakultni Nemocnice V Praze - I. Interni Klinika - Klinika HematologiePraha 2, Czechia, 128 08|Nantes Cedex 1, France, 44093 Chu De Bordeaux - HÃ´pital Haut-LÃ©vÃªquePessac Cedex, France, 33604 Centre Hospitalier Lyon-SudPierre-BÃ©nite, France, 69495 Chu BretonneauTours Cedex 9, France, 37044 Chu Nancy BraboisVandoeuvre Les Nancy, France, 54511|Chemnitz, Germany, 09113 Asklepios Klinik AltonaHamburg, Germany, 22763 Universitaetsklinikum HeidelbergHeidelberg, Germany, 69120 Universitaetsklinikum Tuebingen Der Eberhard-Karls-Universitaet, Abteilung Fuer Innere Medizin Ii,TÃ¼bingen, Germany, 72076|Haifa, Israel, 31096 Carmel Medical CenterHaifa, Israel, 3436212 Hadassah Medical CenterJerusalem, Israel, 9112001 Galilee Medical CenterNahariya, Israel, 22100 Sheba Medical CenterRamat Gan, Israel, 52621 Tel-Aviv Sourasky Medical CenterTel-Aviv, Israel, 64239|Kanazawa, Japan, 920-8641 Matsuyama Red Cross HospitalMatsuyama, Japan, 790-8524 Nagoya City University HospitalNagoya, Japan, 467-8602 Japanese Red Cross Central Medical CenterShibuya, Japan, 150-8935|Badalona, Spain, 08916 Hosp. Univ. Vall D HebronBarcelona, Spain, 08035 Hosp. Clinic I Provincial De BarcelonaBarcelona, Spain, 08036 Inst. Cat. Doncologia-H Duran I ReynalsBarcelona, Spain, 08908 Hosp. Gral. Univ. Gregorio MaranonMadrid, Spain, 28007 Clinica Univ. De NavarraMadrid, Spain, 28027 Hosp. Univ. Ramon Y CajalMadrid, Spain, 28034 Hosp. Univ. 12 De OctubreMadrid, Spain, 28041 Hosp. Son LlatzerMallorca, Spain, 07198 Clinica Univ. De NavarraPamplona, Spain, 31008 Hosp. Clinico Univ. De SalamancaSalamanca, Spain, 37007 Hosp. Univ. Dr. PesetValencia, Spain, 46017|Birmingham, United Kingdom, B9 5Ss Royal Bournemouth HospitalBournemouth, United Kingdom, Bh7 7Dw Kent And Canterbury HospitalCanterbury, United Kingdom, Ct1 3Ng Manchester Royal InfirmaryManchester, United Kingdom, M13 9Wl Derriford HospitalPlymouth, United Kingdom, Pl6 8Dh Royal Stoke University HospitalStoke On Trent, United Kingdom, St4 6Qg|Southington, Connecticut, United States, 06489-3237|Jacksonville, Florida, United States, 32224 Uf Health Cancer Center At Orlando HealthOrlando, Florida, United States, 32806|Detroit, Michigan, United States, 48201 Providence Cancer CenterSouthfield, Michigan, United States, 48075|Billings, Montana, United States, 59101|Lincoln, Nebraska, United States, 68506 Southeast Nebraska Cancer CenterLincoln, Nebraska, United States, 68510 Nebraska Cancer SpecialistsOmaha, Nebraska, United States, 68130|Farmington, New|Mineola, New York, United States, 11501 Mt. Sinai School Of MedicineNew York, New York, United States, 10029|Winston-Salem, North Carolina, United States, 27157|Sioux Falls, South Dakota, United States, 57105|Salt Lake City, Utah, United States, 84121|Charlottesville, Virginia, United States, 22903","Connecticut|Florida|Michigan|Montana|Nebraska|New Mexico|New York|North Carolina|South Dakota|Utah|Virginia","Brazil|Czechia|France|Germany|Israel|Japan|Spain|United Kingdom|United States","Liga Norte Riograndense Contra O Cancer|Fakultni Nemocnice Brno|Chu De Nantes HÃ´tel-Dieu|Klinikum Chemnitz Ggmbh|Rambam Medical Center|Kanazawa University Hospital|Inst. Cat. D'Oncologia-Badalona|Heart Of England Nhs Foundation Trust|Cancer Center Of Central Connecticut - Southington|Mayo Clinic In Florida|Karmonos Cancer Institute|Billings Clinic|Nebraska Hematology And Oncology|San Juan Oncology Associates|Nyu Winthrop|Wake Forest University Baptist Medical Center (Wfubmc) - Comprehensive Cancer Center|Avera Medical Group - Oncology & Hematology|Utah Cancer Specialists|University Of Virginia Cancer Center - Emily Couric Clinical Cancer Center - Women's Oncology Clini",{"$nulls":3},"Janssen Research & Development, LLC Clinical Trial","2018-12-06","2020-05-25T16:38:52.882","2020-05-26T17:10:42.972","NCT03412565"]
["5ecbf49c11702c1b1b916b71","NCT03412565","2019-03-04","Johnson & Johnson","JNJ","Active, not recruiting","A Study to Evaluate Subcutaneous Daratumumab in Combination With Standard Multiple Myeloma Treatment Regimens","Daratumumab|Bortezomib|Lenalidomide|Dexamethasone|Melphalan|Prednisone|Carfilzomib","CD38 Inhibitor|Proteasome Inhibitor|Angiogenesis Inhibitor|GR Agonist|GR Agonist|Immunosuppressive","No",null,"No",null,"Phase 2",4,199,"Actual","2018-04-26","2020-04-17","RR","Response Rate",{"$nulls":3},"The purpose of this study is to evaluate the clinical benefit of subcutaneous (SC) daratumumab administered in combination with standard multiple myeloma (MM) regimens in participants with MM as measured by overall response rate (ORR) or very good partial response (VGPR) or better rate.","The hypothesis is that the addition of daratumumab administered SC to standard MM regimens will improve responses compared to response data observed in completed phase 3 studies without daratumumab. Disease evaluations will include measurements of myeloma proteins, bone marrow examinations, skeletal surveys, assessment of extramedullary plasmacytomas, and measurements of serum calcium corrected for albumin. Safety will be measured by adverse events, laboratory test results, electrocardiogram (ECGs), vital sign measurements, physical examination findings, SC injection-site assessments, and assessment of Eastern Cooperative Oncology Group (ECOG) performance status score. Study will consist of 3 phases (screening, treatment and follow-up) and duration of study is approximately 3 years.","A Multicenter Phase 2 Study to Evaluate Subcutaneous Daratumumab in Combination With Standard Multiple Myeloma Treatment Regimens","CR108435","Multiple Myeloma","Multiple Myeloma","Oncology Hematological","Oncology","Experimental","Daratumumab(D)+Bortezomib+Lenalidomide+Dexamethasone (D-VRd)|D + Bortezomib + Melphalan + Prednisone (D-VMP)|Daratumumab + Lenalidomide + Dexamethasone (D-Rd)|Daratumumab + Carfilzomib + Dexamethasone (D-Kd)","Participants will receive daratumumab 1800 milligram (mg) by subcutaneous (SC) injection on Days 1, 8 and 15 of Cycles 1 to 3 (each cycle of 21 days) and on Day 1 of Cycle 4; bortezomib 1.3 milligram per square meter (mg/m^2) SC injection on Days 1, 4, 8 and 11 of Cycles 1 to 4; lenalidomide 25 mg orally on Day 1 through Day 14 of Cycles 1 to 4 and dexamethasone 20 mg orally or intravenously on Days 1, 2 ,8, 9, 15 and 16 of Cycle 1 to 4.|Participants will receive daratumumab 1800 mg by SC injection on Days 1, 8, 15, 22, 29 and 36 of Cycle 1 then on Days 1 and 22 in Cycles 2 to 9 and Day 1 of Cycle 10 and thereafter until documented progression of disease, unacceptable toxicity, or end of study; bortezomib 1.3 mg/m^2 SC injection on Day 1, 4, 8, 11, 22, 25, 29 and 32 of Cycle 1 and on Days 1, 8, 22 and 29 of Cycles 2 to 9; melphalan 9 mg/m^2 orally on Day 1 through Day 4 of Cycles 1 to 9; prednisone 60 mg/m^2 orally on Days 1 to 4 of cycles 1 to 9.|Participants will receive daratumumab 1800 mg by SC injection on Days 1, 8, 15 and 22 of Cycles 1 and 2 then on Day 1 and 15 of Cycles 3 to 6 and on Day 1 of Cycle 7 and thereafter until documented progression of disease, unacceptable toxicity, or end of study; lenalidomide 25 mg orally on Day 1 through Day 21 of each cycle until documented progression of disease, unacceptable toxicity, or end of study and dexamethasone 40 mg orally or intravenously weekly until documented progression of disease, unacceptable toxicity, or end of study.|Participants will receive daratumumab 1800 mg by SC injection on Days 1, 8, 15 and 22 of Cycles 1 and 2 (each cycle is of 28 days) then on Day 1 and 15 of Cycles 3 to 6 and on Day 1 of Cycle 7 and thereafter until documented progression of disease, unacceptable toxicity, or end of study; Carfilzomib 20 mg/m^2 intravenously (IV) on Day 1 of Cycle 1 only then 70 mg/m^2 IV on Days 8 and 15 of Cycle 1 and Days 1, 8 and 15 of Cycle 2 and thereafter until documented progression of disease, unacceptable toxicity, or end of study and dexamethasone 40 mg orally or IV weekly for Cycles 1-9 then on Days 1, 8, 15 of each cycle for Cycles 10 and thereafter until documented progression of disease, unacceptable toxicity, or end of study.","Drug","Daratumumab|Bortezomib|Lenalidomide|Dexamethasone|Melphalan|Prednisone|Carfilzomib","Daratumumab will be administered at a dose of 1800 mg by SC injection in Cycles 1 to 4 in D-VRd cohort and until documented progression of disease, unacceptable toxicity, or end of study for D-VMP, D-Rd and D-Kd cohorts.|Bortezomib will be administered as 1.3 mg/m^2 SC injection in Cycles 1 to 4 in D-VRd cohort and in Cycles 1 to 9 in D-VMP cohort.|Lenalidomide will be administered as 25 mg capsule orally in Cycles 1 to 4 in D-VRd cohort and in all Cycles until documented progression of disease, unacceptable toxicity, or end of study in D-Rd cohort.|Dexamethasone will be administered as 20 mg orally or intravenously in Cycles 1 to 4 in D-VRd cohort; 40 mg orally or intravenously in all cycles and thereafter until documented progression of disease, unacceptable toxicity, or end of study in D-Rd and D-Kd cohort.|Melphalan will be administered as 9 mg/m^2 orally in Cycles 1 to 9.|Prednisone will be administered as 60 mg/m^2 orally in cycles 1 to 9.|Carfilzomib will be administered as 20 mg/m^2 IV on Day 1 of Cycle 1 only then 70 mg/m^2 IV on Days 8 and 15 of Cycle 1 and Days 1, 8 and 15 of Cycle 2 and thereafter until documented progression of disease, unacceptable toxicity, or end of study in D-Kd cohort.",null,"Daratumumab(D)+Bortezomib+Lenalidomide+Dexamethasone (D-VRd)|D + Bortezomib + Melphalan + Prednisone (D-VMP)|Daratumumab + Lenalidomide + Dexamethasone (D-Rd)|Daratumumab + Carfilzomib + Dexamethasone (D-Kd)","\n\n * Multiple myeloma diagnosed according to the International Myeloma Working Group (IMWG) diagnostic criteria\n * Measurable, secretory disease as defined by any of the following: 1. Serum monoclonal paraprotein (M-protein) level greater than or equal to (>=) 1.0 gram per deciliter (g/dL); or\n    2. Urine M-protein level >= 200 milligram per 24 hours (mg/24 hours); or\n    3. Light chain multiple myeloma (MM), for participants without measurable disease in the serum or urine: serum Immunoglobulin (Ig) free light chain (FLC) >= 10 mg/dL and abnormal FLC ratio\n   \n   \n * Meets one of the sets of the following criteria: 1. For Daratumumab + bortezomib + lenalidomide + dexamethasone (D-VRd) and Daratumumab + bortezomib + melphalan + prednisone + dexamethasone (D-VMP) regimen: newly diagnosed myeloma\n    2. For Daratumumab + lenalidomide + dexamethasone (D-Rd) and Daratumumab + Carfilzomib + Dexamethasone (D-Kd) regimen: relapsed or refractory disease\n    3. D-Kd cohort: Participants must have received only 1 prior line of therapy for MM which included at least 2 consecutive cycles of lenalidomide therapy\n   \n   \n * Eastern Cooperative Oncology Group (ECOG) Performance Status grade of 0, 1, or 2\n * During the study, and for 3 months after receiving the last dose of daratumumab, a woman must agree not to donate eggs (ova, oocytes) and men must agree not to donate sperm for the purposes of assisted reproduction\n\n","\n\n * History of malignancy (other than MM) unless all treatment of that malignancy was completed at least 2 years before consent and the participant has no evidence of disease further exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or breast, or other non-invasive lesion, that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence within 3 years\n * Exhibits clinical signs of meningeal involvement of MM\n * Either of the following: a) Chronic obstructive pulmonary disease with a forced expiratory volume in 1 second (FEV1) is less than (<) 50 percentage (%) of predicted normal b) Moderate or severe persistent asthma, or a history of asthma within the last 2 years, or currently has uncontrolled asthma of any classification c) For D-Kd cohort: Known infiltrative pulmonary disease or known pulmonary hypertension\n * Any of the following: a) Known to be seropositive for human immunodeficiency virus; b) Seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen [HBsAg]). Participants with resolved infection (participants who are HBsAg negative but positive for antibodies to hepatitis B core antigen [Anti-HBc] and/or antibodies to hepatitis B surface antigen [Anti-HBs]) must be screened using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) DNA levels. Those who are polymerase chain reaction (PCR) positive will be excluded\n * Known to be seropositive for hepatitis C (Anti-HCV antibody positive or HCV-RNA quantitation positive) except in the setting of a sustained virologic response [SVR], defined as aviremia at least 12 weeks after completion of antiviral therapy\n * For D-Kd cohort only: Transthoracic echocardiogram showing left ventricular ejection fraction (LVEF) <40%; uncontrolled hypertension, defined as an average systolic blood pressure greater than (>)159 millimeters of mercury (mmHg) or diastolic >99 mmHg despite optimal treatment",{"$nulls":4},"Actual","2018-01-26","Actual","Anticipated","2021-02-01","Anticipated","2019-02-01","2018-01-22","2018-01-22","2019-03-01","No",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Non-Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"2017-004203-41|54767414MMY2040","EudraCT Number|Janssen Research & Development, LLC","D-VMP, D-Kd, and D-Rd Cohort: Overall Response Rate (ORR)|D-VRd Cohort: Very Good Partial Response (VGPR) or Better Rate","The ORR is defined as the percentage of participants who achieve partial response (PR) or better according to international myeloma working group (IMWG) criteria, during or after study treatment for D-VMP, D-Kd and D-Rd cohorts. IMWG criteria for PR: greater than or equal to (>=) 50 percent (%) reduction of serum M-protein and reduction in 24-hour urinary M-protein by >=90% or to less than (<) 200 mg/24 hours, If the serum and urine M-protein are not measurable, a decrease of >=50% in the difference between involved and uninvolved free light chain (FLC) levels is required in place of the M-protein criteria, If serum and urine M-protein are not measurable, and serum free light assay is also not measurable, >=50% reduction in bone marrow plasma cells (PCs) is required in place of M-protein, provided baseline bone marrow plasma cell percentage was >=30%. In addition to the above criteria, if present at baseline, a >=50% reduction in the size of soft tissue plasmacytomas is also required.|The VGPR or better rate, defined as the percentage of participants achieving VGPR or better according IMWG criteria during or after the study treatment in Daratumumab + Bortezomib + Lenalidomide + Dexamethasone (D-VRd) cohort. IMWG criteria for VGPR: Serum and urine M-component detectable by immunofixation but not on electrophoresis, or >= 90 percent (%) reduction in serum M-protein plus urine M-protein <100 milligram per 24 hours (mg/24 hours).","18 months after the last participant enrolled (approximately 2.5 years)","Maximum Observed Serum Concentrations (Cmax) of Daratumumab|Minimum Observed Serum Concentrations (Cmin) of Daratumumab|Percentage of Participants with Infusion-Related Reactions (IRR)|D-Kd, D-VMP, and D-Rd Cohort: Very Good Partial Response (VGPR) or Better Rate|D-VRd Cohort: Overall Response Rate (ORR)|Complete Response or Better Rate|Duration of Response (DOR)|Number of Participants with Anti-Drug Antibodies Against Daratumumab or Recombinant Human Hyaluronidase (rHuPH20)|D-Kd, D-VMP, and D-Rd Cohorts: Percentage of Participants who are Minimal Residual Disease (MRD) Negative","Cmax is defined as maximum concentration observed following daratumumab administration.|Cmin is defined as the minimum concentration observed immediately before daratumumab administration.|The Percentage of Participants with infusion reactions will be reported.|The VGPR or better rate, defined as the percentage of participants achieving VGPR or better rate according IMWG criteria during or after the study treatment for Daratumumab + Carfilzomib + Dexamethasone (D-Kd), Daratumumab + Bortezomib + Melphalan + Prednisone (D-VMP), and Daratumumab + Lenalidomide + Dexamethasone (D-Rd) cohorts. IMWG criteria for VGPR: Serum and urine M-component detectable by immunofixation but not on electrophoresis, or greater than equal to (>=) 90 percent (%) reduction in serum M-protein plus urine M-protein <100 milligram (mg)/24 hours.|The ORR is defined as the proportion of participants who achieve partial response (PR) or better according to IMWG criteria, during or after study treatment for D-VRd cohort. IMWG criteria for PR: greater than or equal to (>=) 50 percent (%) reduction of serum M-protein and reduction in 24-hour urinary M-protein by >=90% or to less than (<) 200 mg/24 hours, If the serum and urine M-protein are not measurable, a decrease of >=50% in the difference between involved and uninvolved free light chain (FLC) levels is required in place of the M-protein criteria, If serum and urine M-protein are not measurable, and serum free light assay is also not measurable, >=50% reduction in bone marrow plasma cells (PCs) is required in place of M-protein, provided baseline bone marrow plasma cell percentage was >=30%. In addition to the above criteria, if present at baseline, a >=50% reduction in the size of soft tissue plasmacytomas is also required.|Complete response is based on serum M-Protein assessments. IMWG criteria for CR: Negative immunofixation on the serum and urine, and disappearance of any soft tissue plasmacytomas, and <5% PCs in bone marrow. Stringent complete response (sCR): CR plus normal FLC ratio, and absence of clonal PCs by immunohistochemistry, immunofluorescence or 2- to 4 color flow cytometry.|Duration of response is defined as the time from the date of initial documented response (PR or better for D-Kd, D-VMP, D-Rd, and D-VRd cohorts) to the date of first documented evidence of progressive disease or death due to progressive disease (PD).|Participants with anti-drug antibodies against daratumumab or rHuPH20 will be analyzed.|Percentage of participants who are MRD negative will be assessed for D-Kd, D-VMP, and D-Rd cohorts. MRD negative is defined as less than (<) 0.01% abnormal population counts to total event counts when measured by flow.","D-VRd: Day 4 of Cycles 1 and 4 and post treatment 4 weeks and at week 8; D-VMP and D-Rd: Day 4 of Cycles 1 and 2 and post treatment 4 weeks and at week 8; D-Kd: Day 4 of Cycles 1 and 3 and post treatment 4 weeks and at week 8|D-VRd: predose on Day 1 of Cycles 1, 3, and 4; D-VMP: predose on Day 1 of Cycles 1, 2, 3, 6 and 9; D-Rd: predose on Day 1 of Cycles 1, 3, 6, 9 and 12 and D-Kd: predose on Day 1 of Cycles 1, 3, 6, 9, and 12|18 months after the last participant enrolled (approximately 2.5 years)|Up to 8 weeks after the last dose of study drug (approximately 1 year)",{"$nulls":3},"Natal, Brazil, 59075-740 Centro De Pesquisa Do Instituto Do CÃ¢ncer- Hospital SÃ£o Vicente De PauloPasso Fundo, Brazil, 99010-090 Instituto Nacional Do Cancer - IncaRio De Janeiro, Brazil, 20230-130 Universidade Federal De Sao PauloSao Paulo, Brazil, 04037-002 Hospital Do Servidor Publico Estadual - IamspeSao Paulo, Brazil Clinica Sao GermanoSÃ£o Paulo, Brazil, 01455-010|Brno, Czechia, 625 00 Fakultni Nemocnice Hradec KraloveHradec Kralove, Czechia, 500 05 Fakultni Nemocnice OstravaOstrava, Czechia, 70852 Vseobecna Fakultni Nemocnice V Praze - I. Interni Klinika - Klinika HematologiePraha 2, Czechia, 128 08|Nantes Cedex 1, France, 44093 Chu De Bordeaux - HÃ´pital Haut-LÃ©vÃªquePessac Cedex, France, 33604 Centre Hospitalier Lyon-SudPierre-BÃ©nite, France, 69495 Chu BretonneauTours Cedex 9, France, 37044 Chu Nancy BraboisVandoeuvre Les Nancy, France, 54511|Chemnitz, Germany, 09113 Asklepios Klinik AltonaHamburg, Germany, 22763 Universitaetsklinikum HeidelbergHeidelberg, Germany, 69120 Universitaetsklinikum Tuebingen Der Eberhard-Karls-Universitaet, Abteilung Fuer Innere Medizin Ii,TÃ¼bingen, Germany, 72076|Haifa, Israel, 31096 Carmel Medical CenterHaifa, Israel, 3436212 Hadassah Medical CenterJerusalem, Israel, 9112001 Galilee Medical CenterNahariya, Israel, 22100 Sheba Medical CenterRamat Gan, Israel, 52621 Tel-Aviv Sourasky Medical CenterTel-Aviv, Israel, 64239|Kanazawa, Japan, 920-8641 Matsuyama Red Cross HospitalMatsuyama, Japan, 790-8524 Nagoya City University HospitalNagoya, Japan, 467-8602 Japanese Red Cross Central Medical CenterShibuya, Japan, 150-8935|Badalona, Spain, 08916 Hosp. Univ. Vall D HebronBarcelona, Spain, 08035 Hosp. Clinic I Provincial De BarcelonaBarcelona, Spain, 08036 Inst. Cat. Doncologia-H Duran I ReynalsBarcelona, Spain, 08908 Hosp. Gral. Univ. Gregorio MaraÃ±onMadrid, Spain, 28007 Clinica Univ. De NavarraMadrid, Spain, 28027 Hosp. Univ. Ramon Y CajalMadrid, Spain, 28034 Hosp. Univ. 12 De OctubreMadrid, Spain, 28041 Hosp. Son LlatzerMallorca, Spain, 07198 Clinica Univ. De NavarraPamplona, Spain, 31008 Hosp. Clinico Univ. De SalamancaSalamanca, Spain, 37007 Hosp. Univ. Dr. PesetValencia, Spain, 46017|Birmingham, United Kingdom, B9 5Ss Royal Bournemouth HospitalBournemouth, United Kingdom, Bh7 7Dw Kent And Canterbury HospitalCanterbury, United Kingdom, Ct1 3Ng Manchester Royal InfirmaryManchester, United Kingdom, M13 9Wl Derriford HospitalPlymouth, United Kingdom, Pl6 8Dh Royal Stoke University HospitalStoke On Trent, United Kingdom, St4 6Qg|Southington, Connecticut, United States, 06489-3237|Jacksonville, Florida, United States, 32224 Uf Health Cancer Center At Orlando HealthOrlando, Florida, United States, 32806|Detroit, Michigan, United States, 48201 Providence Cancer CenterSouthfield, Michigan, United States, 48075|Billings, Montana, United States, 59101|Lincoln, Nebraska, United States, 68506 Southeast Nebraska Cancer CenterLincoln, Nebraska, United States, 68510 Nebraska Cancer SpecialistsOmaha, Nebraska, United States, 68130|Farmington, New|Mineola, New York, United States, 11501 Mt. Sinai School Of MedicineNew York, New York, United States, 10029|Winston-Salem, North Carolina, United States, 27157|Sioux Falls, South Dakota, United States, 57105|Salt Lake City, Utah, United States, 84121|Charlottesville, Virginia, United States, 22903","Connecticut|Florida|Michigan|Montana|Nebraska|New Mexico|New York|North Carolina|South Dakota|Utah|Virginia","Brazil|Czechia|France|Germany|Israel|Japan|Spain|United Kingdom|United States","Liga Norte Riograndense Contra O Cancer|Fakultni Nemocnice Brno|Chu De Nantes HÃ´tel-Dieu|Klinikum Chemnitz Ggmbh|Rambam Medical Center|Kanazawa University Hospital|Inst. Cat. D'Oncologia-Badalona|Heart Of England Nhs Foundation Trust|Cancer Center Of Central Connecticut - Southington|Mayo Clinic In Florida|Karmonos Cancer Institute|Billings Clinic|Nebraska Hematology And Oncology|San Juan Oncology Associates|Nyu Winthrop|Wake Forest University Baptist Medical Center (Wfubmc) - Comprehensive Cancer Center|Avera Medical Group - Oncology & Hematology|Utah Cancer Specialists|University Of Virginia Cancer Center - Emily Couric Clinical Cancer Center - Women's Oncology Clini",{"$nulls":3},"Janssen Research & Development, LLC Clinical Trial","2019-03-01","2020-05-25T16:38:52.885","2020-05-26T17:10:42.972","NCT03412565"]
["5ecbf49d11702c1b1b916b72","NCT03412565","2019-05-24","Johnson & Johnson","JNJ","Recruiting","A Study to Evaluate Subcutaneous Daratumumab in Combination With Standard Multiple Myeloma Treatment Regimens","Daratumumab|Bortezomib|Lenalidomide|Dexamethasone|Melphalan|Prednisone|Carfilzomib","CD38 Inhibitor|Proteasome Inhibitor|Angiogenesis Inhibitor|GR Agonist|GR Agonist|Immunosuppressive","No",null,"No",null,"Phase 2",4,240,"Anticipated","2018-04-26","2020-04-17","RR","Response Rate",{"$nulls":3},"The purpose of this study is to evaluate the clinical benefit of subcutaneous (SC) daratumumab administered in combination with standard multiple myeloma (MM) regimens in participants with MM as measured by overall response rate (ORR) or very good partial response (VGPR) or better rate.","The hypothesis is that the addition of daratumumab administered SC to standard MM regimens will improve responses compared to response data observed in completed phase 3 studies without daratumumab. Disease evaluations will include measurements of myeloma proteins, bone marrow examinations, skeletal surveys, assessment of extramedullary plasmacytomas, and measurements of serum calcium corrected for albumin. Safety will be measured by adverse events, laboratory test results, electrocardiogram (ECGs), vital sign measurements, physical examination findings, SC injection-site assessments, and assessment of Eastern Cooperative Oncology Group (ECOG) performance status score. Study will consist of 3 phases (screening, treatment and follow-up) and duration of study is approximately 3 years.","A Multicenter Phase 2 Study to Evaluate Subcutaneous Daratumumab in Combination With Standard Multiple Myeloma Treatment Regimens","CR108435","Multiple Myeloma","Multiple Myeloma","Oncology Hematological","Oncology","Experimental","Daratumumab(D)+Bortezomib+Lenalidomide+Dexamethasone (D-VRd)|D + Bortezomib + Melphalan + Prednisone (D-VMP)|Daratumumab + Lenalidomide + Dexamethasone (D-Rd)|Daratumumab + Carfilzomib + Dexamethasone (D-Kd)","Participants will receive daratumumab 1800 milligram (mg) by subcutaneous (SC) injection on Days 1, 8 and 15 of Cycles 1 to 3 (each cycle of 21 days) and on Day 1 of Cycle 4; bortezomib 1.3 milligram per square meter (mg/m^2) SC injection on Days 1, 4, 8 and 11 of Cycles 1 to 4; lenalidomide 25 mg orally on Day 1 through Day 14 of Cycles 1 to 4 and dexamethasone 20 mg orally or intravenously on Days 1, 2 ,8, 9, 15 and 16 of Cycle 1 to 4.|Participants will receive daratumumab 1800 mg by SC injection on Days 1, 8, 15, 22, 29 and 36 of Cycle 1 then on Days 1 and 22 in Cycles 2 to 9 and Day 1 of Cycle 10 and thereafter until documented progression of disease, unacceptable toxicity, or end of study; bortezomib 1.3 mg/m^2 SC injection on Day 1, 4, 8, 11, 22, 25, 29 and 32 of Cycle 1 and on Days 1, 8, 22 and 29 of Cycles 2 to 9; melphalan 9 mg/m^2 orally on Day 1 through Day 4 of Cycles 1 to 9; prednisone 60 mg/m^2 orally on Days 1 to 4 of cycles 1 to 9.|Participants will receive daratumumab 1800 mg by SC injection on Days 1, 8, 15 and 22 of Cycles 1 and 2 then on Day 1 and 15 of Cycles 3 to 6 and on Day 1 of Cycle 7 and thereafter until documented progression of disease, unacceptable toxicity, or end of study; lenalidomide 25 mg orally on Day 1 through Day 21 of each cycle until documented progression of disease, unacceptable toxicity, or end of study and dexamethasone 40 mg orally or intravenously weekly until documented progression of disease, unacceptable toxicity, or end of study.|Participants will receive daratumumab 1800 mg by SC injection on Days 1, 8, 15 and 22 of Cycles 1 and 2 (each cycle is of 28 days) then on Day 1 and 15 of Cycles 3 to 6 and on Day 1 of Cycle 7 and thereafter until documented progression of disease, unacceptable toxicity, or end of study; Carfilzomib 20 mg/m^2 intravenously (IV) on Day 1 of Cycle 1 only then 70 mg/m^2 IV on Days 8 and 15 of Cycle 1 and Days 1, 8 and 15 of Cycle 2 and thereafter until documented progression of disease, unacceptable toxicity, or end of study and dexamethasone 40 mg orally or IV weekly for Cycles 1-9 then on Days 1, 8, 15 of each cycle for Cycles 10 and thereafter until documented progression of disease, unacceptable toxicity, or end of study.","Drug","Daratumumab|Bortezomib|Lenalidomide|Dexamethasone|Melphalan|Prednisone|Carfilzomib","Daratumumab will be administered at a dose of 1800 mg by SC injection in Cycles 1 to 4 in D-VRd cohort and until documented progression of disease, unacceptable toxicity, or end of study for D-VMP, D-Rd and D-Kd cohorts.|Bortezomib will be administered as 1.3 mg/m^2 SC injection in Cycles 1 to 4 in D-VRd cohort and in Cycles 1 to 9 in D-VMP cohort.|Lenalidomide will be administered as 25 mg capsule orally in Cycles 1 to 4 in D-VRd cohort and in all Cycles until documented progression of disease, unacceptable toxicity, or end of study in D-Rd cohort.|Dexamethasone will be administered as 20 mg orally or intravenously in Cycles 1 to 4 in D-VRd cohort; 40 mg orally or intravenously in all cycles and thereafter until documented progression of disease, unacceptable toxicity, or end of study in D-Rd and D-Kd cohort.|Melphalan will be administered as 9 mg/m^2 orally in Cycles 1 to 9.|Prednisone will be administered as 60 mg/m^2 orally in cycles 1 to 9.|Carfilzomib will be administered as 20 mg/m^2 IV on Day 1 of Cycle 1 only then 70 mg/m^2 IV on Days 8 and 15 of Cycle 1 and Days 1, 8 and 15 of Cycle 2 and thereafter until documented progression of disease, unacceptable toxicity, or end of study in D-Kd cohort.",null,"Daratumumab(D)+Bortezomib+Lenalidomide+Dexamethasone (D-VRd)|D + Bortezomib + Melphalan + Prednisone (D-VMP)|Daratumumab + Lenalidomide + Dexamethasone (D-Rd)|Daratumumab + Carfilzomib + Dexamethasone (D-Kd)","\n\n * Multiple myeloma diagnosed according to the International Myeloma Working Group (IMWG) diagnostic criteria\n * Measurable, secretory disease as defined by any of the following: 1. Serum monoclonal paraprotein (M-protein) level greater than or equal to (>=) 1.0 gram per deciliter (g/dL); or\n    2. Urine M-protein level >= 200 milligram per 24 hours (mg/24 hours); or\n    3. Light chain multiple myeloma (MM), for participants without measurable disease in the serum or urine: serum Immunoglobulin (Ig) free light chain (FLC) >= 10 mg/dL and abnormal FLC ratio\n   \n   \n * Meets one of the sets of the following criteria: 1. For Daratumumab + bortezomib + lenalidomide + dexamethasone (D-VRd) and Daratumumab + bortezomib + melphalan + prednisone + dexamethasone (D-VMP) regimen: newly diagnosed myeloma\n    2. For Daratumumab + lenalidomide + dexamethasone (D-Rd) and Daratumumab + Carfilzomib + Dexamethasone (D-Kd) regimen: relapsed or refractory disease\n    3. D-Kd cohort: Participants must have received only 1 prior line of therapy for MM which included at least 2 consecutive cycles of lenalidomide therapy\n   \n   \n * Eastern Cooperative Oncology Group (ECOG) Performance Status grade of 0, 1, or 2\n * During the study, and for 3 months after receiving the last dose of daratumumab, a woman must agree not to donate eggs (ova, oocytes) and men must agree not to donate sperm for the purposes of assisted reproduction\n\n","\n\n * History of malignancy (other than MM) unless all treatment of that malignancy was completed at least 2 years before consent and the participant has no evidence of disease further exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or breast, or other non-invasive lesion, that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence within 3 years\n * Exhibits clinical signs of meningeal involvement of MM\n * Either of the following: a) Chronic obstructive pulmonary disease with a forced expiratory volume in 1 second (FEV1) is less than (<) 50 percentage (%) of predicted normal b) Moderate or severe persistent asthma, or a history of asthma within the last 2 years, or currently has uncontrolled asthma of any classification c) For D-Kd cohort: Known infiltrative pulmonary disease or known pulmonary hypertension\n * Any of the following: a) Known to be seropositive for human immunodeficiency virus; b) Seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen [HBsAg]). Participants with resolved infection (participants who are HBsAg negative but positive for antibodies to hepatitis B core antigen [Anti-HBc] and/or antibodies to hepatitis B surface antigen [Anti-HBs]) must be screened using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) DNA levels. Those who are polymerase chain reaction (PCR) positive will be excluded\n * Known to be seropositive for hepatitis C (Anti-HCV antibody positive or HCV-RNA quantitation positive) except in the setting of a sustained virologic response [SVR], defined as aviremia at least 12 weeks after completion of antiviral therapy\n * For D-Kd cohort only: Transthoracic echocardiogram showing left ventricular ejection fraction (LVEF) <40%; uncontrolled hypertension, defined as an average systolic blood pressure greater than (>)159 millimeters of mercury (mmHg) or diastolic >99 mmHg despite optimal treatment",{"$nulls":4},"Actual","2018-01-26","Actual","Anticipated","2021-02-01","Anticipated","2019-05-01","2018-01-22","2018-01-22","2019-05-23","No",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Non-Randomized","18 Years",null,"All",null,"No",null,null,"URL: http://pam.sylogent.com/cr/CR108435 [http://pam.sylogent.com/cr/CR108435] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To learn how to participate in this trial please click here.",null,"Yes","No",{"$nulls":17},"2017-004203-41|54767414MMY2040","EudraCT Number|Janssen Research & Development, LLC","D-VMP, D-Kd, and D-Rd Cohort: Overall Response Rate (ORR)|D-VRd Cohort: Very Good Partial Response (VGPR) or Better Rate","The ORR is defined as the percentage of participants who achieve partial response (PR) or better according to international myeloma working group (IMWG) criteria, during or after study treatment for D-VMP, D-Kd and D-Rd cohorts. IMWG criteria for PR: greater than or equal to (>=) 50 percent (%) reduction of serum M-protein and reduction in 24-hour urinary M-protein by >=90% or to less than (<) 200 mg/24 hours, If the serum and urine M-protein are not measurable, a decrease of >=50% in the difference between involved and uninvolved free light chain (FLC) levels is required in place of the M-protein criteria, If serum and urine M-protein are not measurable, and serum free light assay is also not measurable, >=50% reduction in bone marrow plasma cells (PCs) is required in place of M-protein, provided baseline bone marrow plasma cell percentage was >=30%. In addition to the above criteria, if present at baseline, a >=50% reduction in the size of soft tissue plasmacytomas is also required.|The VGPR or better rate, defined as the percentage of participants achieving VGPR or better according IMWG criteria during or after the study treatment in Daratumumab + Bortezomib + Lenalidomide + Dexamethasone (D-VRd) cohort. IMWG criteria for VGPR: Serum and urine M-component detectable by immunofixation but not on electrophoresis, or >= 90 percent (%) reduction in serum M-protein plus urine M-protein <100 milligram per 24 hours (mg/24 hours).","18 months after the last participant enrolled (approximately 2.5 years)","Maximum Observed Serum Concentrations (Cmax) of Daratumumab|Minimum Observed Serum Concentrations (Cmin) of Daratumumab|Percentage of Participants with Infusion-Related Reactions (IRR)|D-Kd, D-VMP, and D-Rd Cohort: Very Good Partial Response (VGPR) or Better Rate|D-VRd Cohort: Overall Response Rate (ORR)|Complete Response or Better Rate|Duration of Response (DOR)|Number of Participants with Anti-Drug Antibodies Against Daratumumab or Recombinant Human Hyaluronidase (rHuPH20)|D-Kd, D-VMP, and D-Rd Cohorts: Percentage of Participants who are Minimal Residual Disease (MRD) Negative","Cmax is defined as maximum concentration observed following daratumumab administration.|Cmin is defined as the minimum concentration observed immediately before daratumumab administration.|The Percentage of Participants with infusion reactions will be reported.|The VGPR or better rate, defined as the percentage of participants achieving VGPR or better rate according IMWG criteria during or after the study treatment for Daratumumab + Carfilzomib + Dexamethasone (D-Kd), Daratumumab + Bortezomib + Melphalan + Prednisone (D-VMP), and Daratumumab + Lenalidomide + Dexamethasone (D-Rd) cohorts. IMWG criteria for VGPR: Serum and urine M-component detectable by immunofixation but not on electrophoresis, or greater than equal to (>=) 90 percent (%) reduction in serum M-protein plus urine M-protein <100 milligram (mg)/24 hours.|The ORR is defined as the proportion of participants who achieve partial response (PR) or better according to IMWG criteria, during or after study treatment for D-VRd cohort. IMWG criteria for PR: greater than or equal to (>=) 50 percent (%) reduction of serum M-protein and reduction in 24-hour urinary M-protein by >=90% or to less than (<) 200 mg/24 hours, If the serum and urine M-protein are not measurable, a decrease of >=50% in the difference between involved and uninvolved free light chain (FLC) levels is required in place of the M-protein criteria, If serum and urine M-protein are not measurable, and serum free light assay is also not measurable, >=50% reduction in bone marrow plasma cells (PCs) is required in place of M-protein, provided baseline bone marrow plasma cell percentage was >=30%. In addition to the above criteria, if present at baseline, a >=50% reduction in the size of soft tissue plasmacytomas is also required.|Complete response is based on serum M-Protein assessments. IMWG criteria for CR: Negative immunofixation on the serum and urine, and disappearance of any soft tissue plasmacytomas, and <5% PCs in bone marrow. Stringent complete response (sCR): CR plus normal FLC ratio, and absence of clonal PCs by immunohistochemistry, immunofluorescence or 2- to 4 color flow cytometry.|Duration of response is defined as the time from the date of initial documented response (PR or better for D-Kd, D-VMP, D-Rd, and D-VRd cohorts) to the date of first documented evidence of progressive disease or death due to progressive disease (PD).|Participants with anti-drug antibodies against daratumumab or rHuPH20 will be analyzed.|Percentage of participants who are MRD negative will be assessed for D-Kd, D-VMP, and D-Rd cohorts. MRD negative is defined as less than (<) 0.01% abnormal population counts to total event counts when measured by flow.","D-VRd: Day 4 of Cycles 1 and 4 and post treatment 4 weeks and at week 8; D-VMP and D-Rd: Day 4 of Cycles 1 and 2 and post treatment 4 weeks and at week 8; D-Kd: Day 4 of Cycles 1 and 3 and post treatment 4 weeks and at week 8|D-VRd: predose on Day 1 of Cycles 1, 3, and 4; D-VMP: predose on Day 1 of Cycles 1, 2, 3, 6 and 9; D-Rd: predose on Day 1 of Cycles 1, 3, 6, 9 and 12 and D-Kd: predose on Day 1 of Cycles 1, 3, 6, 9, and 12|18 months after the last participant enrolled (approximately 2.5 years)|Up to 8 weeks after the last dose of study drug (approximately 1 year)","JNJ.CT@sylogent.com","Study Contact","844-434-4210","Fortaleza, Brazil, 60430-230 Liga Norte Riograndense Contra O Cancer[Active, Not Recruiting]Natal, Brazil, 59075-740 Centro De Pesquisa Do Instituto Do CÃ¢ncer- Hospital SÃ£o Vicente De PauloPasso Fundo, Brazil, 99010-090 Hospital MÃ£e De Deus CenterPorto Alegre, Brazil, 90470-340 Instituto Nacional Do Cancer - IncaRio De Janeiro, Brazil, 20230-130 Universidade Federal De Sao Paulo[Active, Not Recruiting]Sao Paulo, Brazil, 04037-002 Hospital Do Servidor Publico Estadual - IamspeSao Paulo, Brazil Clinica Sao Germano[Active, Not Recruiting]SÃ£o Paulo, Brazil, 01455-010|Brno, Czechia, 625 00 Fakultni Nemocnice Hradec KraloveHradec Kralove, Czechia, 500 05 Fakultni Nemocnice OstravaOstrava, Czechia, 70852 Vseobecna Fakultni Nemocnice V Praze - I. Interni Klinika - Klinika HematologiePraha 2, Czechia, 128 08|Nantes Cedex 1, France, 44093 Chu De Bordeaux - HÃ´pital Haut-LÃ©vÃªquePessac Cedex, France, 33604 Centre Hospitalier Lyon-SudPierre-BÃ©nite, France, 69495 Chu BretonneauTours Cedex 9, France, 37044 Chu Nancy BraboisVandoeuvre Les Nancy, France, 54511|Chemnitz, Germany, 09113 Asklepios Klinik AltonaHamburg, Germany, 22763 Universitaetsklinikum HeidelbergHeidelberg, Germany, 69120 Universitaetsklinikum Tuebingen Der Eberhard-Karls-Universitaet, Abteilung Fuer Innere Medizin Ii,TÃ¼bingen, Germany, 72076|Haifa, Israel, 31096 Carmel Medical CenterHaifa, Israel, 3436212 Hadassah Medical CenterJerusalem, Israel, 9112001 Galilee Medical CenterNahariya, Israel, 22100 Sheba Medical CenterRamat Gan, Israel, 52621 Tel-Aviv Sourasky Medical CenterTel-Aviv, Israel, 64239|Kanazawa, Japan, 920-8641 Matsuyama Red Cross HospitalMatsuyama, Japan, 790-8524 Nagoya City University HospitalNagoya, Japan, 467-8602 Japanese Red Cross Central Medical CenterShibuya, Japan, 150-8935 Korea, Republic Of Keimyung University Dongsan HospitalDaegu, Korea, Republic Of, 700-712 Yeungnam University Medical CenterDaegu, Korea, Republic Of, 705-703 Chungnam National University HospitalDaejeon, Korea, Republic Of, 35015 Chonnam National University Hwasun HospitalHwasun Gun, Korea, Republic Of, 58128 Seoul National University Bundang HospitalSeongnam-Si, Korea, Republic Of, 13620 Korea Cancer Center HospitalSeoul, Korea, Republic Of, 01812 Seoul National University HospitalSeoul, Korea, Republic Of, 03080|Badalona, Spain, 08916 Hosp. Univ. Vall D HebronBarcelona, Spain, 08035 Hosp. Clinic I Provincial De BarcelonaBarcelona, Spain, 08036 Inst. Cat. Doncologia-H Duran I ReynalsBarcelona, Spain, 08908 Hosp. Gral. Univ. Gregorio MaraÃ±onMadrid, Spain, 28007 Clinica Univ. De NavarraMadrid, Spain, 28027 Hosp. Univ. Ramon Y CajalMadrid, Spain, 28034 Hosp. Univ. 12 De OctubreMadrid, Spain, 28041 Hosp. Son LlatzerMallorca, Spain, 07198 Clinica Univ. De NavarraPamplona, Spain, 31008 Hosp. Clinico Univ. De SalamancaSalamanca, Spain, 37007 Hosp. Univ. Dr. PesetValencia, Spain, 46017|Birmingham, United Kingdom, B9 5Ss Royal Bournemouth HospitalBournemouth, United Kingdom, Bh7 7Dw Kent And Canterbury HospitalCanterbury, United Kingdom, Ct1 3Ng Manchester Royal InfirmaryManchester, United Kingdom, M13 9Wl Derriford HospitalPlymouth, United Kingdom, Pl6 8Dh Royal Stoke University HospitalStoke On Trent, United Kingdom, St4 6Qg|Farmington, Connecticut, United States, 06030 Cancer Center Of Central Connecticut - SouthingtonSouthington, Connecticut, United States, 06489-3237|Jacksonville, Florida, United States, 32224 Watson Clinic LlpLakeland, Florida, United States, 33805 Uf Health Cancer Center At Orlando HealthOrlando, Florida, United States, 32806|Iowa City, Iowa, United States, 52242|Baltimore, Maryland, United States, 21201|Detroit, Michigan, United States, 48201 Providence Cancer CenterSouthfield, Michigan, United States, 48075|Billings, Montana, United States, 59101|Lincoln, Nebraska, United States, 68506 Southeast Nebraska Cancer CenterLincoln, Nebraska, United States, 68510 Nebraska Cancer SpecialistsOmaha, Nebraska, United States, 68130 University Of Nebraska Medical CenterOmaha, Nebraska, United States, 68198|Ridgewood, New Jersey, United States, 07450|Farmington, New|East Hills, New York, United States, 11548 Queens Medical Associates, PcFresh Meadows, New York, United States, 11366 Northwell HealthLake Success, New York, United States, 11042 Nyu WinthropMineola, New York, United States, 11501 Mt. Sinai School Of MedicineNew York, New York, United States, 10029|Chapel Hill, North Carolina, United States, 27599 Wake Forest University Baptist Medical Center (Wfubmc) - Comprehensive Cancer CenterWinston-Salem, North Carolina, United States, 27157|Spartanburg, South Carolina, United States, 29303|Sioux Falls, South Dakota, United States, 57105|Salt Lake City, Utah, United States, 84121|Charlottesville, Virginia, United States, 22903|Seattle, Washington, United States, 98101","Connecticut|Florida|Iowa|Maryland|Michigan|Montana|Nebraska|New Jersey|New Mexico|New York|North Carolina|South Carolina|South Dakota|Utah|Virginia|Washington","Brazil|Czechia|France|Germany|Israel|Japan|Spain|United Kingdom|United States","Instituto Do Cancer Do Ceara|Fakultni Nemocnice Brno|Chu De Nantes HÃ´tel-Dieu|Klinikum Chemnitz Ggmbh|Rambam Medical Center|Kanazawa University Hospital|Inst. Cat. D'Oncologia-Badalona|Heart Of England Nhs Foundation Trust|University Of Connecticut|Mayo Clinic In Florida|University Of Iowa Hospitals & Clinics|University Of Maryland|Karmonos Cancer Institute|Billings Clinic|Nebraska Hematology And Oncology|The Valley Hospital|San Juan Oncology Associates|St Francis Hospital|University Of North Carolina|Gibbs Cancer Center|Avera Medical Group - Oncology & Hematology|Utah Cancer Specialists|University Of Virginia Cancer Center - Emily Couric Clinical Cancer Center - Women's Oncology Clinic|Virginia Mason Medical Center",{"$nulls":3},"Janssen Research & Development, LLC Clinical Trial","2019-05-23","2020-05-25T16:38:53.248","2020-05-26T17:10:42.972","NCT03412565"]
["5ecbf49dfeab101b15530995","NCT03412565","2019-08-15","Johnson & Johnson","JNJ","Recruiting","A Study to Evaluate Subcutaneous Daratumumab in Combination With Standard Multiple Myeloma Treatment Regimens","Daratumumab|Bortezomib|Lenalidomide|Dexamethasone|Melphalan|Prednisone|Carfilzomib","CD38 Inhibitor|Proteasome Inhibitor|Angiogenesis Inhibitor|GR Agonist|GR Agonist|Immunosuppressive","No",null,"No",null,"Phase 2",4,240,"Anticipated","2018-04-26","2020-09-27","RR","Response Rate",{"$nulls":3},"The purpose of this study is to evaluate the clinical benefit of subcutaneous (SC) daratumumab administered in combination with standard multiple myeloma (MM) regimens in participants with MM as measured by overall response rate (ORR) or very good partial response (VGPR) or better rate.","The hypothesis is that the addition of daratumumab administered SC to standard MM regimens will improve responses compared to response data observed in completed phase 3 studies without daratumumab. Disease evaluations will include measurements of myeloma proteins, bone marrow examinations, skeletal surveys, assessment of extramedullary plasmacytomas, and measurements of serum calcium corrected for albumin. Safety will be measured by adverse events, laboratory test results, electrocardiogram (ECGs), vital sign measurements, physical examination findings, SC injection-site assessments, and assessment of Eastern Cooperative Oncology Group (ECOG) performance status score. Study will consist of 3 phases (screening, treatment and follow-up) and duration of study is approximately 3 years.","A Multicenter Phase 2 Study to Evaluate Subcutaneous Daratumumab in Combination With Standard Multiple Myeloma Treatment Regimens","CR108435","Multiple Myeloma","Multiple Myeloma","Oncology Hematological","Oncology","Experimental","Daratumumab(D)+Bortezomib+Lenalidomide+Dexamethasone (D-VRd)|D + Bortezomib + Melphalan + Prednisone (D-VMP)|Daratumumab + Lenalidomide + Dexamethasone (D-Rd)|Daratumumab + Carfilzomib + Dexamethasone (D-Kd)","Participants will receive daratumumab 1800 milligram (mg) by subcutaneous (SC) injection on Days 1, 8 and 15 of Cycles 1 to 3 (each cycle of 21 days) and on Day 1 of Cycle 4; bortezomib 1.3 milligram per square meter (mg/m^2) SC injection on Days 1, 4, 8 and 11 of Cycles 1 to 4; lenalidomide 25 mg orally on Day 1 through Day 14 of Cycles 1 to 4 and dexamethasone 20 mg orally or intravenously on Days 1, 2 ,8, 9, 15 and 16 of Cycle 1 to 4.|Participants will receive daratumumab 1800 mg by SC injection on Days 1, 8, 15, 22, 29 and 36 of Cycle 1 then on Days 1 and 22 in Cycles 2 to 9 and Day 1 of Cycle 10 and thereafter until documented progression of disease, unacceptable toxicity, or end of study; bortezomib 1.3 mg/m^2 SC injection on Day 1, 4, 8, 11, 22, 25, 29 and 32 of Cycle 1 and on Days 1, 8, 22 and 29 of Cycles 2 to 9; melphalan 9 mg/m^2 orally on Day 1 through Day 4 of Cycles 1 to 9; prednisone 60 mg/m^2 orally on Days 1 to 4 of cycles 1 to 9.|Participants will receive daratumumab 1800 mg by SC injection on Days 1, 8, 15 and 22 of Cycles 1 and 2 then on Day 1 and 15 of Cycles 3 to 6 and on Day 1 of Cycle 7 and thereafter until documented progression of disease, unacceptable toxicity, or end of study; lenalidomide 25 mg orally on Day 1 through Day 21 of each cycle until documented progression of disease, unacceptable toxicity, or end of study and dexamethasone 40 mg orally or intravenously weekly until documented progression of disease, unacceptable toxicity, or end of study.|Participants will receive daratumumab 1800 mg by SC injection on Days 1, 8, 15 and 22 of Cycles 1 and 2 (each cycle is of 28 days) then on Day 1 and 15 of Cycles 3 to 6 and on Day 1 of Cycle 7 and thereafter until documented progression of disease, unacceptable toxicity, or end of study; Carfilzomib 20 mg/m^2 intravenously (IV) on Day 1 of Cycle 1 only then 70 mg/m^2 IV on Days 8 and 15 of Cycle 1 and Days 1, 8 and 15 of Cycle 2 and thereafter until documented progression of disease, unacceptable toxicity, or end of study and dexamethasone 40 mg orally or IV weekly for Cycles 1-9 then on Days 1, 8, 15 of each cycle for Cycles 10 and thereafter until documented progression of disease, unacceptable toxicity, or end of study.","Drug","Daratumumab|Bortezomib|Lenalidomide|Dexamethasone|Melphalan|Prednisone|Carfilzomib","Daratumumab will be administered at a dose of 1800 mg by SC injection in Cycles 1 to 4 in D-VRd cohort and until documented progression of disease, unacceptable toxicity, or end of study for D-VMP, D-Rd and D-Kd cohorts.|Bortezomib will be administered as 1.3 mg/m^2 SC injection in Cycles 1 to 4 in D-VRd cohort and in Cycles 1 to 9 in D-VMP cohort.|Lenalidomide will be administered as 25 mg capsule orally in Cycles 1 to 4 in D-VRd cohort and in all Cycles until documented progression of disease, unacceptable toxicity, or end of study in D-Rd cohort.|Dexamethasone will be administered as 20 mg orally or intravenously in Cycles 1 to 4 in D-VRd cohort; 40 mg orally or intravenously in all cycles and thereafter until documented progression of disease, unacceptable toxicity, or end of study in D-Rd and D-Kd cohort.|Melphalan will be administered as 9 mg/m^2 orally in Cycles 1 to 9.|Prednisone will be administered as 60 mg/m^2 orally in cycles 1 to 9.|Carfilzomib will be administered as 20 mg/m^2 IV on Day 1 of Cycle 1 only then 70 mg/m^2 IV on Days 8 and 15 of Cycle 1 and Days 1, 8 and 15 of Cycle 2 and thereafter until documented progression of disease, unacceptable toxicity, or end of study in D-Kd cohort.",null,"Daratumumab(D)+Bortezomib+Lenalidomide+Dexamethasone (D-VRd)|D + Bortezomib + Melphalan + Prednisone (D-VMP)|Daratumumab + Lenalidomide + Dexamethasone (D-Rd)|Daratumumab + Carfilzomib + Dexamethasone (D-Kd)","\n\n * Multiple myeloma diagnosed according to the International Myeloma Working Group (IMWG) diagnostic criteria\n * Measurable, secretory disease as defined by any of the following: 1. Serum monoclonal paraprotein (M-protein) level greater than or equal to (>=) 1.0 gram per deciliter (g/dL); or\n    2. Urine M-protein level >= 200 milligram per 24 hours (mg/24 hours); or\n    3. Light chain multiple myeloma (MM), for participants without measurable disease in the serum or urine: serum Immunoglobulin (Ig) free light chain (FLC) >= 10 mg/dL and abnormal FLC ratio\n   \n   \n * Meets one of the sets of the following criteria: 1. For Daratumumab + bortezomib + lenalidomide + dexamethasone (D-VRd) and Daratumumab + bortezomib + melphalan + prednisone + dexamethasone (D-VMP) regimen: newly diagnosed myeloma\n    2. For Daratumumab + lenalidomide + dexamethasone (D-Rd) and Daratumumab + Carfilzomib + Dexamethasone (D-Kd) regimen: relapsed or refractory disease\n    3. D-Kd cohort: Participants must have received only 1 prior line of therapy for MM which included at least 2 consecutive cycles of lenalidomide therapy\n   \n   \n * Eastern Cooperative Oncology Group (ECOG) Performance Status grade of 0, 1, or 2\n * During the study, and for 3 months after receiving the last dose of daratumumab, a woman must agree not to donate eggs (ova, oocytes) and men must agree not to donate sperm for the purposes of assisted reproduction\n\n","\n\n * History of malignancy (other than MM) unless all treatment of that malignancy was completed at least 2 years before consent and the participant has no evidence of disease further exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or breast, or other non-invasive lesion, that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence within 3 years\n * Exhibits clinical signs of meningeal involvement of MM\n * Either of the following: a) Chronic obstructive pulmonary disease with a forced expiratory volume in 1 second (FEV1) is less than (<) 50 percentage (%) of predicted normal b) Moderate or severe persistent asthma, or a history of asthma within the last 2 years, or currently has uncontrolled asthma of any classification c) For D-Kd cohort: Known infiltrative pulmonary disease or known pulmonary hypertension\n * Any of the following: a) Known to be seropositive for human immunodeficiency virus; b) Seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen [HBsAg]). Participants with resolved infection (participants who are HBsAg negative but positive for antibodies to hepatitis B core antigen [Anti-HBc] and/or antibodies to hepatitis B surface antigen [Anti-HBs]) must be screened using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) DNA levels. Those who are polymerase chain reaction (PCR) positive will be excluded\n * Known to be seropositive for hepatitis C (Anti-HCV antibody positive or HCV-RNA quantitation positive) except in the setting of a sustained virologic response [SVR], defined as aviremia at least 12 weeks after completion of antiviral therapy\n * For D-Kd cohort only: Transthoracic echocardiogram showing left ventricular ejection fraction (LVEF) <40%; uncontrolled hypertension, defined as an average systolic blood pressure greater than (>)159 millimeters of mercury (mmHg) or diastolic >99 mmHg despite optimal treatment",{"$nulls":4},"Actual","2018-01-26","Actual","Anticipated","2021-11-26","Anticipated","2019-08-01","2018-01-22","2018-01-22","2019-08-14","No",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Non-Randomized","18 Years",null,"All",null,"No",null,null,"URL: http://pam.sylogent.com/cr/CR108435 [http://pam.sylogent.com/cr/CR108435] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To learn how to participate in this trial please click here.",null,"Yes","No",{"$nulls":17},"2017-004203-41|54767414MMY2040","EudraCT Number|Janssen Research & Development, LLC","D-VMP, D-Kd, and D-Rd Cohort: Overall Response Rate (ORR)|D-VRd Cohort: Very Good Partial Response (VGPR) or Better Rate","The ORR is defined as the percentage of participants who achieve partial response (PR) or better according to international myeloma working group (IMWG) criteria, during or after study treatment for D-VMP, D-Kd and D-Rd cohorts. IMWG criteria for PR: greater than or equal to (>=) 50 percent (%) reduction of serum M-protein and reduction in 24-hour urinary M-protein by >=90% or to less than (<) 200 mg/24 hours, If the serum and urine M-protein are not measurable, a decrease of >=50% in the difference between involved and uninvolved free light chain (FLC) levels is required in place of the M-protein criteria, If serum and urine M-protein are not measurable, and serum free light assay is also not measurable, >=50% reduction in bone marrow plasma cells (PCs) is required in place of M-protein, provided baseline bone marrow plasma cell percentage was >=30%. In addition to the above criteria, if present at baseline, a >=50% reduction in the size of soft tissue plasmacytomas is also required.|The VGPR or better rate, defined as the percentage of participants achieving VGPR or better according IMWG criteria during or after the study treatment in Daratumumab + Bortezomib + Lenalidomide + Dexamethasone (D-VRd) cohort. IMWG criteria for VGPR: Serum and urine M-component detectable by immunofixation but not on electrophoresis, or >= 90 percent (%) reduction in serum M-protein plus urine M-protein <100 milligram per 24 hours (mg/24 hours).","18 months after the last participant enrolled (approximately 2.5 years)","Maximum Observed Serum Concentrations (Cmax) of Daratumumab|Minimum Observed Serum Concentrations (Cmin) of Daratumumab|Percentage of Participants with Infusion-Related Reactions (IRR)|D-Kd, D-VMP, and D-Rd Cohort: Very Good Partial Response (VGPR) or Better Rate|D-VRd Cohort: Overall Response Rate (ORR)|Complete Response or Better Rate|Duration of Response (DOR)|Number of Participants with Anti-Drug Antibodies Against Daratumumab or Recombinant Human Hyaluronidase (rHuPH20)|D-Kd, D-VMP, and D-Rd Cohorts: Percentage of Participants who are Minimal Residual Disease (MRD) Negative","Cmax is defined as maximum concentration observed following daratumumab administration.|Cmin is defined as the minimum concentration observed immediately before daratumumab administration.|The Percentage of Participants with infusion reactions will be reported.|The VGPR or better rate, defined as the percentage of participants achieving VGPR or better rate according IMWG criteria during or after the study treatment for Daratumumab + Carfilzomib + Dexamethasone (D-Kd), Daratumumab + Bortezomib + Melphalan + Prednisone (D-VMP), and Daratumumab + Lenalidomide + Dexamethasone (D-Rd) cohorts. IMWG criteria for VGPR: Serum and urine M-component detectable by immunofixation but not on electrophoresis, or greater than equal to (>=) 90 percent (%) reduction in serum M-protein plus urine M-protein <100 milligram (mg)/24 hours.|The ORR is defined as the proportion of participants who achieve partial response (PR) or better according to IMWG criteria, during or after study treatment for D-VRd cohort. IMWG criteria for PR: greater than or equal to (>=) 50 percent (%) reduction of serum M-protein and reduction in 24-hour urinary M-protein by >=90% or to less than (<) 200 mg/24 hours, If the serum and urine M-protein are not measurable, a decrease of >=50% in the difference between involved and uninvolved free light chain (FLC) levels is required in place of the M-protein criteria, If serum and urine M-protein are not measurable, and serum free light assay is also not measurable, >=50% reduction in bone marrow plasma cells (PCs) is required in place of M-protein, provided baseline bone marrow plasma cell percentage was >=30%. In addition to the above criteria, if present at baseline, a >=50% reduction in the size of soft tissue plasmacytomas is also required.|Complete response is based on serum M-Protein assessments. IMWG criteria for CR: Negative immunofixation on the serum and urine, and disappearance of any soft tissue plasmacytomas, and <5% PCs in bone marrow. Stringent complete response (sCR): CR plus normal FLC ratio, and absence of clonal PCs by immunohistochemistry, immunofluorescence or 2- to 4 color flow cytometry.|Duration of response is defined as the time from the date of initial documented response (PR or better for D-Kd, D-VMP, D-Rd, and D-VRd cohorts) to the date of first documented evidence of progressive disease or death due to progressive disease (PD).|Participants with anti-drug antibodies against daratumumab or rHuPH20 will be analyzed.|Percentage of participants who are MRD negative will be assessed for D-Kd, D-VMP, and D-Rd cohorts. MRD negative is defined as less than (<) 0.01% abnormal population counts to total event counts when measured by flow.","D-VRd: Day 4 of Cycles 1 and 4 and post treatment 4 weeks and at week 8; D-VMP and D-Rd: Day 4 of Cycles 1 and 2 and post treatment 4 weeks and at week 8; D-Kd: Day 4 of Cycles 1 and 3 and post treatment 4 weeks and at week 8|D-VRd: predose on Day 1 of Cycles 1, 3, and 4; D-VMP: predose on Day 1 of Cycles 1, 2, 3, 6 and 9; D-Rd: predose on Day 1 of Cycles 1, 3, 6, 9 and 12 and D-Kd: predose on Day 1 of Cycles 1, 3, 6, 9, and 12|18 months after the last participant enrolled (approximately 2.5 years)|Up to 8 weeks after the last dose of study drug (approximately 1 year)","JNJ.CT@sylogent.com","Study Contact","844-434-4210","Fortaleza, Brazil, 60430-230 Liga Norte Riograndense Contra O Cancer[Active, Not Recruiting]Natal, Brazil, 59075-740 Centro De Pesquisa Do Instituto Do CÃ¢ncer- Hospital SÃ£o Vicente De PauloPasso Fundo, Brazil, 99010-090 Hospital MÃ£e De Deus CenterPorto Alegre, Brazil, 90470-340 Instituto Nacional Do Cancer - IncaRio De Janeiro, Brazil, 20230-130 Universidade Federal De Sao Paulo[Active, Not Recruiting]Sao Paulo, Brazil, 04037-002 Hospital Do Servidor Publico Estadual - IamspeSao Paulo, Brazil Clinica Sao Germano[Active, Not Recruiting]SÃ£o Paulo, Brazil, 01455-010|Brno, Czechia, 625 00 Fakultni Nemocnice Hradec KraloveHradec Kralove, Czechia, 500 05 Fakultni Nemocnice OstravaOstrava, Czechia, 70852 Vseobecna Fakultni Nemocnice V Praze - I. Interni Klinika - Klinika HematologiePraha 2, Czechia, 128 08|Nantes Cedex 1, France, 44093 Chu De Bordeaux - HÃ´pital Haut-LÃ©vÃªquePessac Cedex, France, 33604 Centre Hospitalier Lyon-SudPierre-BÃ©nite, France, 69495 Chu BretonneauTours Cedex 9, France, 37044 Chu Nancy BraboisVandoeuvre Les Nancy, France, 54511|Chemnitz, Germany, 09113 Universitaetsklinikum Hamburg EppendorfHamburg, Germany, 20246 Asklepios Klinik AltonaHamburg, Germany, 22763 Universitaetsklinikum HeidelbergHeidelberg, Germany, 69120 Universitaetsklinikum Tuebingen Der Eberhard-Karls-Universitaet, Abteilung Fuer Innere Medizin Ii,TÃ¼bingen, Germany, 72076|[Active, Not Recruiting]Haifa, Israel, 31096 Carmel Medical Center[Active, Not Recruiting]Haifa, Israel, 3436212 Hadassah Medical CenterJerusalem, Israel, 9112001 Galilee Medical Center[Active, Not Recruiting]Nahariya, Israel, 22100 Sheba Medical Center[Active, Not Recruiting]Ramat Gan, Israel, 52621 Tel-Aviv Sourasky Medical Center[Active, Not Recruiting]Tel-Aviv, Israel, 64239|[Active, Not Recruiting]Kanazawa, Japan, 920-8641 Matsuyama Red Cross HospitalMatsuyama, Japan, 790-8524 Nagoya City University Hospital[Active, Not Recruiting]Nagoya, Japan, 467-8602 Japanese Red Cross Central Medical Center[Active, Not Recruiting]Shibuya, Japan, 150-8935 Korea, Republic Of Keimyung University Dongsan HospitalDaegu, Korea, Republic Of, 700-712 Yeungnam University Medical CenterDaegu, Korea, Republic Of, 705-703 Chungnam National University HospitalDaejeon, Korea, Republic Of, 35015 Chonnam National University Hwasun HospitalHwasun Gun, Korea, Republic Of, 58128 Seoul National University Bundang HospitalSeongnam-Si, Korea, Republic Of, 13620 Korea Cancer Center HospitalSeoul, Korea, Republic Of, 01812 Seoul National University HospitalSeoul, Korea, Republic Of, 03080|Badalona, Spain, 08916 Hosp. Univ. Vall D HebronBarcelona, Spain, 08035 Hosp. Clinic I Provincial De BarcelonaBarcelona, Spain, 08036 Inst. Cat. Doncologia-H Duran I ReynalsBarcelona, Spain, 08908 Hosp. Gral. Univ. Gregorio MaraÃ±onMadrid, Spain, 28007 Clinica Univ. De NavarraMadrid, Spain, 28027 Hosp. Univ. Ramon Y CajalMadrid, Spain, 28034 Hosp. Univ. 12 De OctubreMadrid, Spain, 28041 Hosp. Son LlatzerMallorca, Spain, 07198 Clinica Univ. De NavarraPamplona, Spain, 31008 Hosp. Clinico Univ. De SalamancaSalamanca, Spain, 37007 Hosp. Univ. Dr. PesetValencia, Spain, 46017|Birmingham, United Kingdom, B9 5Ss Royal Bournemouth HospitalBournemouth, United Kingdom, Bh7 7Dw Kent And Canterbury HospitalCanterbury, United Kingdom, Ct1 3Ng Manchester Royal InfirmaryManchester, United Kingdom, M13 9Wl Derriford HospitalPlymouth, United Kingdom, Pl6 8Dh Royal Stoke University HospitalStoke On Trent, United Kingdom, St4 6Qg|Farmington, Connecticut, United States, 06030 Cancer Center Of Central Connecticut - SouthingtonSouthington, Connecticut, United States, 06489-3237|Jacksonville, Florida, United States, 32224 Watson Clinic LlpLakeland, Florida, United States, 33805 Uf Health Cancer Center At Orlando HealthOrlando, Florida, United States, 32806|Iowa City, Iowa, United States, 52242|Baltimore, Maryland, United States, 21201|Detroit, Michigan, United States, 48201 Providence Cancer CenterSouthfield, Michigan, United States, 48075|Billings, Montana, United States, 59101|Lincoln, Nebraska, United States, 68506 Southeast Nebraska Cancer CenterLincoln, Nebraska, United States, 68510 Nebraska Cancer SpecialistsOmaha, Nebraska, United States, 68130 University Of Nebraska Medical CenterOmaha, Nebraska, United States, 68198|Ridgewood, New Jersey, United States, 07450|Farmington, New|East Hills, New York, United States, 11548 Queens Medical Associates, PcFresh Meadows, New York, United States, 11366 Northwell HealthLake Success, New York, United States, 11042 Nyu WinthropMineola, New York, United States, 11501 Mt. Sinai School Of MedicineNew York, New York, United States, 10029|Chapel Hill, North Carolina, United States, 27599 Wake Forest University Baptist Medical Center (Wfubmc) - Comprehensive Cancer CenterWinston-Salem, North Carolina, United States, 27157|Spartanburg, South Carolina, United States, 29303|Sioux Falls, South Dakota, United States, 57105|Salt Lake City, Utah, United States, 84121|Charlottesville, Virginia, United States, 22903|Seattle, Washington, United States, 98101","Connecticut|Florida|Iowa|Maryland|Michigan|Montana|Nebraska|New Jersey|New Mexico|New York|North Carolina|South Carolina|South Dakota|Utah|Virginia|Washington","Brazil|Czechia|France|Germany|Israel|Japan|Spain|United Kingdom|United States","Instituto Do Cancer Do Ceara|Fakultni Nemocnice Brno|Chu De Nantes HÃ´tel-Dieu|Klinikum Chemnitz Ggmbh|Rambam Medical Center|Kanazawa University Hospital|Inst. Cat. D'Oncologia-Badalona|Heart Of England Nhs Foundation Trust|University Of Connecticut|Mayo Clinic In Florida|University Of Iowa Hospitals & Clinics|University Of Maryland|Karmonos Cancer Institute|Billings Clinic|Nebraska Hematology And Oncology|The Valley Hospital|San Juan Oncology Associates|St Francis Hospital|University Of North Carolina|Gibbs Cancer Center|Avera Medical Group - Oncology & Hematology|Utah Cancer Specialists|University Of Virginia Cancer Center - Emily Couric Clinical Cancer Center - Women's Oncology Clinic|Virginia Mason Medical Center",{"$nulls":3},"Janssen Research & Development, LLC Clinical Trial","2019-08-14","2020-05-25T16:38:53.546","2020-05-26T17:10:42.972","NCT03412565"]
["5ecbf49d307e3d1b1f8d9df7","NCT03412565","2020-01-03","Johnson & Johnson","JNJ","Recruiting","A Study to Evaluate Subcutaneous Daratumumab in Combination With Standard Multiple Myeloma Treatment Regimens","Daratumumab|Bortezomib|Lenalidomide|Dexamethasone|Melphalan|Prednisone|Carfilzomib","CD38 Inhibitor|Proteasome Inhibitor|Angiogenesis Inhibitor|GR Agonist|GR Agonist|Immunosuppressive","No",null,"No",null,"Phase 2",4,240,"Anticipated","2018-04-26","2020-09-27","RR","Response Rate",{"$nulls":3},"The purpose of this study is to evaluate the clinical benefit of subcutaneous (SC) daratumumab administered in combination with standard multiple myeloma (MM) regimens in participants with MM as measured by overall response rate (ORR) or very good partial response (VGPR) or better rate.","The hypothesis is that the addition of daratumumab administered SC to standard MM regimens will improve responses compared to response data observed in completed phase 3 studies without daratumumab. Disease evaluations will include measurements of myeloma proteins, bone marrow examinations, skeletal surveys, assessment of extramedullary plasmacytomas, and measurements of serum calcium corrected for albumin. Safety will be measured by adverse events, laboratory test results, electrocardiogram (ECGs), vital sign measurements, physical examination findings, SC injection-site assessments, and assessment of Eastern Cooperative Oncology Group (ECOG) performance status score. Study will consist of 3 phases (screening, treatment and follow-up) and duration of study is approximately 3 years.","A Multicenter Phase 2 Study to Evaluate Subcutaneous Daratumumab in Combination With Standard Multiple Myeloma Treatment Regimens","CR108435","Multiple Myeloma","Multiple Myeloma","Oncology Hematological","Oncology","Experimental","Daratumumab(D)+Bortezomib+Lenalidomide+Dexamethasone (D-VRd)|D + Bortezomib + Melphalan + Prednisone (D-VMP)|Daratumumab + Lenalidomide + Dexamethasone (D-Rd)|Daratumumab + Carfilzomib + Dexamethasone (D-Kd)","Participants will receive daratumumab 1800 milligram (mg) by subcutaneous (SC) injection on Days 1, 8 and 15 of Cycles 1 to 3 (each cycle of 21 days) and on Day 1 of Cycle 4; bortezomib 1.3 milligram per square meter (mg/m^2) SC injection on Days 1, 4, 8 and 11 of Cycles 1 to 4; lenalidomide 25 mg orally on Day 1 through Day 14 of Cycles 1 to 4 and dexamethasone 20 mg orally or intravenously on Days 1, 2 ,8, 9, 15 and 16 of Cycle 1 to 4.|Participants will receive daratumumab 1800 mg by SC injection on Days 1, 8, 15, 22, 29 and 36 of Cycle 1 then on Days 1 and 22 in Cycles 2 to 9 and Day 1 of Cycle 10 and thereafter until documented progression of disease, unacceptable toxicity, or end of study; bortezomib 1.3 mg/m^2 SC injection on Day 1, 4, 8, 11, 22, 25, 29 and 32 of Cycle 1 and on Days 1, 8, 22 and 29 of Cycles 2 to 9; melphalan 9 mg/m^2 orally on Day 1 through Day 4 of Cycles 1 to 9; prednisone 60 mg/m^2 orally on Days 1 to 4 of cycles 1 to 9.|Participants will receive daratumumab 1800 mg by SC injection on Days 1, 8, 15 and 22 of Cycles 1 and 2 then on Day 1 and 15 of Cycles 3 to 6 and on Day 1 of Cycle 7 and thereafter until documented progression of disease, unacceptable toxicity, or end of study; lenalidomide 25 mg orally on Day 1 through Day 21 of each cycle until documented progression of disease, unacceptable toxicity, or end of study and dexamethasone 40 mg orally or intravenously weekly until documented progression of disease, unacceptable toxicity, or end of study.|Participants will receive daratumumab 1800 mg by SC injection on Days 1, 8, 15 and 22 of Cycles 1 and 2 (each cycle is of 28 days) then on Day 1 and 15 of Cycles 3 to 6 and on Day 1 of Cycle 7 and thereafter until documented progression of disease, unacceptable toxicity, or end of study; Carfilzomib 20 mg/m^2 intravenously (IV) on Day 1 of Cycle 1 only then 70 mg/m^2 IV on Days 8 and 15 of Cycle 1 and Days 1, 8 and 15 of Cycle 2 and thereafter until documented progression of disease, unacceptable toxicity, or end of study and dexamethasone 40 mg orally or IV weekly for Cycles 1-9 then on Days 1, 8, 15 of each cycle for Cycles 10 and thereafter until documented progression of disease, unacceptable toxicity, or end of study.","Drug","Daratumumab|Bortezomib|Lenalidomide|Dexamethasone|Melphalan|Prednisone|Carfilzomib","Daratumumab will be administered at a dose of 1800 mg by SC injection in Cycles 1 to 4 in D-VRd cohort and until documented progression of disease, unacceptable toxicity, or end of study for D-VMP, D-Rd and D-Kd cohorts.|Bortezomib will be administered as 1.3 mg/m^2 SC injection in Cycles 1 to 4 in D-VRd cohort and in Cycles 1 to 9 in D-VMP cohort.|Lenalidomide will be administered as 25 mg capsule orally in Cycles 1 to 4 in D-VRd cohort and in all Cycles until documented progression of disease, unacceptable toxicity, or end of study in D-Rd cohort.|Dexamethasone will be administered as 20 mg orally or intravenously in Cycles 1 to 4 in D-VRd cohort; 40 mg orally or intravenously in all cycles and thereafter until documented progression of disease, unacceptable toxicity, or end of study in D-Rd and D-Kd cohort.|Melphalan will be administered as 9 mg/m^2 orally in Cycles 1 to 9.|Prednisone will be administered as 60 mg/m^2 orally in cycles 1 to 9.|Carfilzomib will be administered as 20 mg/m^2 IV on Day 1 of Cycle 1 only then 70 mg/m^2 IV on Days 8 and 15 of Cycle 1 and Days 1, 8 and 15 of Cycle 2 and thereafter until documented progression of disease, unacceptable toxicity, or end of study in D-Kd cohort.",null,"Daratumumab(D)+Bortezomib+Lenalidomide+Dexamethasone (D-VRd)|D + Bortezomib + Melphalan + Prednisone (D-VMP)|Daratumumab + Lenalidomide + Dexamethasone (D-Rd)|Daratumumab + Carfilzomib + Dexamethasone (D-Kd)","\n\n * Multiple myeloma diagnosed according to the International Myeloma Working Group (IMWG) diagnostic criteria\n * Measurable, secretory disease as defined by any of the following: 1. Serum monoclonal paraprotein (M-protein) level greater than or equal to (>=) 1.0 gram per deciliter (g/dL); or\n    2. Urine M-protein level >= 200 milligram per 24 hours (mg/24 hours); or\n    3. Light chain multiple myeloma (MM), for participants without measurable disease in the serum or urine: serum Immunoglobulin (Ig) free light chain (FLC) >= 10 mg/dL and abnormal FLC ratio\n   \n   \n * Meets one of the sets of the following criteria: 1. For Daratumumab + bortezomib + lenalidomide + dexamethasone (D-VRd) and Daratumumab + bortezomib + melphalan + prednisone + dexamethasone (D-VMP) regimen: newly diagnosed myeloma\n    2. For Daratumumab + lenalidomide + dexamethasone (D-Rd) and Daratumumab + Carfilzomib + Dexamethasone (D-Kd) regimen: relapsed or refractory disease\n    3. D-Kd cohort: Participants must have received only 1 prior line of therapy for MM which included at least 2 consecutive cycles of lenalidomide therapy\n   \n   \n * Eastern Cooperative Oncology Group (ECOG) Performance Status grade of 0, 1, or 2\n * During the study, and for 3 months after receiving the last dose of daratumumab, a woman must agree not to donate eggs (ova, oocytes) and men must agree not to donate sperm for the purposes of assisted reproduction\n\n","\n\n * History of malignancy (other than MM) unless all treatment of that malignancy was completed at least 2 years before consent and the participant has no evidence of disease further exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or breast, or other non-invasive lesion, that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence within 3 years\n * Exhibits clinical signs of meningeal involvement of MM\n * Either of the following: a) Chronic obstructive pulmonary disease with a forced expiratory volume in 1 second (FEV1) is less than (<) 50 percentage (%) of predicted normal b) Moderate or severe persistent asthma, or a history of asthma within the last 2 years, or currently has uncontrolled asthma of any classification c) For D-Kd cohort: Known infiltrative pulmonary disease or known pulmonary hypertension\n * Any of the following: a) Known to be seropositive for human immunodeficiency virus; b) Seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen [HBsAg]). Participants with resolved infection (participants who are HBsAg negative but positive for antibodies to hepatitis B core antigen [Anti-HBc] and/or antibodies to hepatitis B surface antigen [Anti-HBs]) must be screened using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) DNA levels. Those who are polymerase chain reaction (PCR) positive will be excluded\n * Known to be seropositive for hepatitis C (Anti-HCV antibody positive or HCV-RNA quantitation positive) except in the setting of a sustained virologic response [SVR], defined as aviremia at least 12 weeks after completion of antiviral therapy\n * For D-Kd cohort only: Transthoracic echocardiogram showing left ventricular ejection fraction (LVEF) <40%; uncontrolled hypertension, defined as an average systolic blood pressure greater than (>)159 millimeters of mercury (mmHg) or diastolic >99 mmHg despite optimal treatment",{"$nulls":4},"Actual","2018-01-26","Actual","Anticipated","2021-11-26","Anticipated","2020-01-01","2018-01-22","2018-01-22","2020-01-02","No",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Non-Randomized","18 Years",null,"All",null,"No",null,null,"URL: http://pam.sylogent.com/cr/CR108435 [http://pam.sylogent.com/cr/CR108435] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To learn how to participate in this trial please click here.",null,"Yes","No",{"$nulls":17},"2017-004203-41|54767414MMY2040","EudraCT Number|Janssen Research & Development, LLC","D-VMP, D-Kd, and D-Rd Cohort: Overall Response Rate (ORR)|D-VRd Cohort: Very Good Partial Response (VGPR) or Better Rate","The ORR is defined as the percentage of participants who achieve partial response (PR) or better according to international myeloma working group (IMWG) criteria, during or after study treatment for D-VMP, D-Kd and D-Rd cohorts. IMWG criteria for PR: greater than or equal to (>=) 50 percent (%) reduction of serum M-protein and reduction in 24-hour urinary M-protein by >=90% or to less than (<) 200 mg/24 hours, If the serum and urine M-protein are not measurable, a decrease of >=50% in the difference between involved and uninvolved free light chain (FLC) levels is required in place of the M-protein criteria, If serum and urine M-protein are not measurable, and serum free light assay is also not measurable, >=50% reduction in bone marrow plasma cells (PCs) is required in place of M-protein, provided baseline bone marrow plasma cell percentage was >=30%. In addition to the above criteria, if present at baseline, a >=50% reduction in the size of soft tissue plasmacytomas is also required.|The VGPR or better rate, defined as the percentage of participants achieving VGPR or better according IMWG criteria during or after the study treatment in Daratumumab + Bortezomib + Lenalidomide + Dexamethasone (D-VRd) cohort. IMWG criteria for VGPR: Serum and urine M-component detectable by immunofixation but not on electrophoresis, or >= 90 percent (%) reduction in serum M-protein plus urine M-protein <100 milligram per 24 hours (mg/24 hours).","18 months after the last participant enrolled (approximately 2.5 years)","Maximum Observed Serum Concentrations (Cmax) of Daratumumab|Minimum Observed Serum Concentrations (Cmin) of Daratumumab|Percentage of Participants with Infusion-Related Reactions (IRR)|D-Kd, D-VMP, and D-Rd Cohort: Very Good Partial Response (VGPR) or Better Rate|D-VRd Cohort: Overall Response Rate (ORR)|Complete Response or Better Rate|Duration of Response (DOR)|Number of Participants with Anti-Drug Antibodies Against Daratumumab or Recombinant Human Hyaluronidase (rHuPH20)|D-Kd, D-VMP, and D-Rd Cohorts: Percentage of Participants who are Minimal Residual Disease (MRD) Negative","Cmax is defined as maximum concentration observed following daratumumab administration.|Cmin is defined as the minimum concentration observed immediately before daratumumab administration.|The Percentage of Participants with infusion reactions will be reported.|The VGPR or better rate, defined as the percentage of participants achieving VGPR or better rate according IMWG criteria during or after the study treatment for Daratumumab + Carfilzomib + Dexamethasone (D-Kd), Daratumumab + Bortezomib + Melphalan + Prednisone (D-VMP), and Daratumumab + Lenalidomide + Dexamethasone (D-Rd) cohorts. IMWG criteria for VGPR: Serum and urine M-component detectable by immunofixation but not on electrophoresis, or greater than equal to (>=) 90 percent (%) reduction in serum M-protein plus urine M-protein <100 milligram (mg)/24 hours.|The ORR is defined as the proportion of participants who achieve partial response (PR) or better according to IMWG criteria, during or after study treatment for D-VRd cohort. IMWG criteria for PR: greater than or equal to (>=) 50 percent (%) reduction of serum M-protein and reduction in 24-hour urinary M-protein by >=90% or to less than (<) 200 mg/24 hours, If the serum and urine M-protein are not measurable, a decrease of >=50% in the difference between involved and uninvolved free light chain (FLC) levels is required in place of the M-protein criteria, If serum and urine M-protein are not measurable, and serum free light assay is also not measurable, >=50% reduction in bone marrow plasma cells (PCs) is required in place of M-protein, provided baseline bone marrow plasma cell percentage was >=30%. In addition to the above criteria, if present at baseline, a >=50% reduction in the size of soft tissue plasmacytomas is also required.|Complete response is based on serum M-Protein assessments. IMWG criteria for CR: Negative immunofixation on the serum and urine, and disappearance of any soft tissue plasmacytomas, and <5% PCs in bone marrow. Stringent complete response (sCR): CR plus normal FLC ratio, and absence of clonal PCs by immunohistochemistry, immunofluorescence or 2- to 4 color flow cytometry.|Duration of response is defined as the time from the date of initial documented response (PR or better for D-Kd, D-VMP, D-Rd, and D-VRd cohorts) to the date of first documented evidence of progressive disease or death due to progressive disease (PD).|Participants with anti-drug antibodies against daratumumab or rHuPH20 will be analyzed.|Percentage of participants who are MRD negative will be assessed for D-Kd, D-VMP, and D-Rd cohorts. MRD negative is defined as less than (<) 0.01% abnormal population counts to total event counts when measured by flow.","D-VRd: Day 4 of Cycles 1 and 4 and post treatment 4 weeks and at week 8; D-VMP and D-Rd: Day 4 of Cycles 1 and 2 and post treatment 4 weeks and at week 8; D-Kd: Day 4 of Cycles 1 and 3 and post treatment 4 weeks and at week 8|D-VRd: predose on Day 1 of Cycles 1, 3, and 4; D-VMP: predose on Day 1 of Cycles 1, 2, 3, 6 and 9; D-Rd: predose on Day 1 of Cycles 1, 3, 6, 9 and 12 and D-Kd: predose on Day 1 of Cycles 1, 3, 6, 9, and 12|18 months after the last participant enrolled (approximately 2.5 years)|Up to 8 weeks after the last dose of study drug (approximately 1 year)","JNJ.CT@sylogent.com","Study Contact","844-434-4210","Fortaleza, Brazil, 60430-230 Liga Norte Riograndense Contra O Cancer[Active, Not Recruiting]Natal, Brazil, 59075-740 Centro De Pesquisa Do Instituto Do CÃ¢ncer- Hospital SÃ£o Vicente De PauloPasso Fundo, Brazil, 99010-090 Hospital MÃ£e De Deus CenterPorto Alegre, Brazil, 90470-340 Instituto Nacional Do Cancer - IncaRio De Janeiro, Brazil, 20230-130 Universidade Federal De Sao Paulo[Active, Not Recruiting]Sao Paulo, Brazil, 04037-002 Hospital Do Servidor Publico Estadual - IamspeSao Paulo, Brazil Clinica Sao Germano[Active, Not Recruiting]SÃ£o Paulo, Brazil, 01455-010|[Active, Not Recruiting]Brno, Czechia, 625 00 Fakultni Nemocnice Hradec Kralove[Active, Not Recruiting]Hradec Kralove, Czechia, 500 05 Fakultni Nemocnice Ostrava[Active, Not Recruiting]Ostrava, Czechia, 70852 Vseobecna Fakultni Nemocnice V Praze - I. Interni Klinika - Klinika HematologiePraha 2, Czechia, 128 08|Nantes Cedex 1, France, 44093 Chu De Bordeaux - HÃ´pital Haut-LÃ©vÃªquePessac Cedex, France, 33604 Centre Hospitalier Lyon-SudPierre-BÃ©nite, France, 69495 Chu BretonneauTours Cedex 9, France, 37044 Chu Nancy BraboisVandoeuvre Les Nancy, France, 54511|Chemnitz, Germany, 09113 Universitaetsklinikum Hamburg EppendorfHamburg, Germany, 20246 Asklepios Klinik AltonaHamburg, Germany, 22763 Universitaetsklinikum HeidelbergHeidelberg, Germany, 69120 Universitaetsklinikum Tuebingen Der Eberhard-Karls-Universitaet, Abteilung Fuer Innere Medizin Ii,TÃ¼bingen, Germany, 72076|[Active, Not Recruiting]Haifa, Israel, 31096 Carmel Medical Center[Active, Not Recruiting]Haifa, Israel, 3436212 Hadassah Medical CenterJerusalem, Israel, 9112001 Galilee Medical Center[Active, Not Recruiting]Nahariya, Israel, 22100 Sheba Medical Center[Active, Not Recruiting]Ramat Gan, Israel, 52621 Tel-Aviv Sourasky Medical Center[Active, Not Recruiting]Tel-Aviv, Israel, 64239|[Active, Not Recruiting]Kanazawa, Japan, 920-8641 Matsuyama Red Cross HospitalMatsuyama, Japan, 790-8524 Nagoya City University Hospital[Active, Not Recruiting]Nagoya, Japan, 467-8602 Japanese Red Cross Central Medical Center[Active, Not Recruiting]Shibuya, Japan, 150-8935 Korea, Republic Of Keimyung University Dongsan HospitalDaegu, Korea, Republic Of, 700-712 Yeungnam University Medical CenterDaegu, Korea, Republic Of, 705-703 Chungnam National University HospitalDaejeon, Korea, Republic Of, 35015 Chonnam National University Hwasun HospitalHwasun Gun, Korea, Republic Of, 58128 Seoul National University Bundang HospitalSeongnam-Si, Korea, Republic Of, 13620 Korea Cancer Center HospitalSeoul, Korea, Republic Of, 01812 Seoul National University HospitalSeoul, Korea, Republic Of, 03080|Badalona, Spain, 08916 Hosp. Clinic I Provincial De BarcelonaBarcelona, Spain, 08036 Inst. Cat. Doncologia-H Duran I ReynalsBarcelona, Spain, 08908 Hosp. Univ. Vall D'HebronBarcelona, Spain, 8035 Hosp. Gral. Univ. Gregorio MaraÃ±onMadrid, Spain, 28007 Clinica Univ. De NavarraMadrid, Spain, 28027 Hosp. Univ. Ramon Y CajalMadrid, Spain, 28034 Hosp. Univ. 12 De OctubreMadrid, Spain, 28041 Hosp. Son LlatzerMallorca, Spain, 07198 Clinica Univ. De NavarraPamplona, Spain, 31008 Hosp. Clinico Univ. De SalamancaSalamanca, Spain, 37007 Hosp. Univ. Dr. PesetValencia, Spain, 46017|[Active, Not Recruiting]Birmingham, United Kingdom, B9 5Ss Royal Bournemouth Hospital[Active, Not Recruiting]Bournemouth, United Kingdom, Bh7 7Dw Kent And Canterbury Hospital[Active, Not Recruiting]Canterbury, United Kingdom, Ct1 3Ng Manchester Royal InfirmaryManchester, United Kingdom, M13 9Wl Derriford Hospital[Active, Not Recruiting]Plymouth, United Kingdom, Pl6 8Dh Royal Stoke University Hospital[Active, Not Recruiting]Stoke On Trent, United Kingdom, St4 6Qg|Farmington, Connecticut, United States, 06030 Cancer Center Of Central Connecticut - SouthingtonSouthington, Connecticut, United States, 06489-3237|Jacksonville, Florida, United States, 32224 Watson Clinic LlpLakeland, Florida, United States, 33805 Uf Health Cancer Center At Orlando HealthOrlando, Florida, United States, 32806|Iowa City, Iowa, United States, 52242|Baltimore, Maryland, United States, 21201|Detroit, Michigan, United States, 48201 Providence Cancer CenterSouthfield, Michigan, United States, 48075|Billings, Montana, United States, 59101|Lincoln, Nebraska, United States, 68506 Southeast Nebraska Cancer CenterLincoln, Nebraska, United States, 68510 Nebraska Cancer SpecialistsOmaha, Nebraska, United States, 68130 University Of Nebraska Medical CenterOmaha, Nebraska, United States, 68198|Ridgewood, New Jersey, United States, 07450|Farmington, New|East Hills, New York, United States, 11548 Queens Medical Associates, PcFresh Meadows, New York, United States, 11366 Northwell HealthLake Success, New York, United States, 11042 Nyu WinthropMineola, New York, United States, 11501 Mt. Sinai School Of MedicineNew York, New York, United States, 10029|Chapel Hill, North Carolina, United States, 27599 Wake Forest University Baptist Medical Center (Wfubmc) - Comprehensive Cancer CenterWinston-Salem, North Carolina, United States, 27157|Spartanburg, South Carolina, United States, 29303|Sioux Falls, South Dakota, United States, 57105|Salt Lake City, Utah, United States, 84121|Charlottesville, Virginia, United States, 22903|Seattle, Washington, United States, 98101","Connecticut|Florida|Iowa|Maryland|Michigan|Montana|Nebraska|New Jersey|New Mexico|New York|North Carolina|South Carolina|South Dakota|Utah|Virginia|Washington","Brazil|Czechia|France|Germany|Israel|Japan|Spain|United Kingdom|United States","Instituto Do Cancer Do Ceara|Fakultni Nemocnice Brno|Chu De Nantes HÃ´tel-Dieu|Klinikum Chemnitz Ggmbh|Rambam Medical Center|Kanazawa University Hospital|Inst. Cat. D'Oncologia-Badalona|Heart Of England Nhs Foundation Trust|University Of Connecticut|Mayo Clinic In Florida|University Of Iowa Hospitals & Clinics|University Of Maryland|Karmonos Cancer Institute|Billings Clinic|Nebraska Hematology And Oncology|The Valley Hospital|San Juan Oncology Associates|St Francis Hospital|University Of North Carolina|Gibbs Cancer Center|Avera Medical Group - Oncology & Hematology|Utah Cancer Specialists|University Of Virginia Cancer Center - Emily Couric Clinical Cancer Center - Women's Oncology Clinic|Virginia Mason Medical Center",{"$nulls":3},"Janssen Research & Development, LLC Clinical Trial","2020-01-02","2020-05-25T16:38:53.458","2020-05-26T17:10:42.972","NCT03412565"]
["5ecbf49dfeab101b15530996","NCT03412565","2020-01-31","Johnson & Johnson","JNJ","Recruiting","A Study to Evaluate Subcutaneous Daratumumab in Combination With Standard Multiple Myeloma Treatment Regimens","Daratumumab|Bortezomib|Lenalidomide|Dexamethasone|Melphalan|Prednisone|Carfilzomib","CD38 Inhibitor|Proteasome Inhibitor|Angiogenesis Inhibitor|GR Agonist|GR Agonist|Immunosuppressive","No",null,"No",null,"Phase 2",4,240,"Anticipated","2018-04-26","2020-09-27","RR","Response Rate",{"$nulls":3},"The purpose of this study is to evaluate the clinical benefit of subcutaneous (SC) daratumumab administered in combination with standard multiple myeloma (MM) regimens in participants with MM as measured by overall response rate (ORR) or very good partial response (VGPR) or better rate.","The hypothesis is that the addition of daratumumab administered SC to standard MM regimens will improve responses compared to response data observed in completed phase 3 studies without daratumumab. Disease evaluations will include measurements of myeloma proteins, bone marrow examinations, skeletal surveys, assessment of extramedullary plasmacytomas, and measurements of serum calcium corrected for albumin. Safety will be measured by adverse events, laboratory test results, electrocardiogram (ECGs), vital sign measurements, physical examination findings, SC injection-site assessments, and assessment of Eastern Cooperative Oncology Group (ECOG) performance status score. Study will consist of 3 phases (screening, treatment and follow-up) and duration of study is approximately 3 years.","A Multicenter Phase 2 Study to Evaluate Subcutaneous Daratumumab in Combination With Standard Multiple Myeloma Treatment Regimens","CR108435","Multiple Myeloma","Multiple Myeloma","Oncology Hematological","Oncology","Experimental","Daratumumab(D)+Bortezomib+Lenalidomide+Dexamethasone (D-VRd)|D + Bortezomib + Melphalan + Prednisone (D-VMP)|Daratumumab + Lenalidomide + Dexamethasone (D-Rd)|Daratumumab + Carfilzomib + Dexamethasone (D-Kd)","Participants will receive daratumumab 1800 milligram (mg) by subcutaneous (SC) injection on Days 1, 8 and 15 of Cycles 1 to 3 (each cycle of 21 days) and on Day 1 of Cycle 4; bortezomib 1.3 milligram per square meter (mg/m^2) SC injection on Days 1, 4, 8 and 11 of Cycles 1 to 4; lenalidomide 25 mg orally on Day 1 through Day 14 of Cycles 1 to 4 and dexamethasone 20 mg orally or intravenously on Days 1, 2 ,8, 9, 15 and 16 of Cycle 1 to 4.|Participants will receive daratumumab 1800 mg by SC injection on Days 1, 8, 15, 22, 29 and 36 of Cycle 1 then on Days 1 and 22 in Cycles 2 to 9 and Day 1 of Cycle 10 and thereafter until documented progression of disease, unacceptable toxicity, or end of study; bortezomib 1.3 mg/m^2 SC injection on Day 1, 4, 8, 11, 22, 25, 29 and 32 of Cycle 1 and on Days 1, 8, 22 and 29 of Cycles 2 to 9; melphalan 9 mg/m^2 orally on Day 1 through Day 4 of Cycles 1 to 9; prednisone 60 mg/m^2 orally on Days 1 to 4 of cycles 1 to 9.|Participants will receive daratumumab 1800 mg by SC injection on Days 1, 8, 15 and 22 of Cycles 1 and 2 then on Day 1 and 15 of Cycles 3 to 6 and on Day 1 of Cycle 7 and thereafter until documented progression of disease, unacceptable toxicity, or end of study; lenalidomide 25 mg orally on Day 1 through Day 21 of each cycle until documented progression of disease, unacceptable toxicity, or end of study and dexamethasone 40 mg orally or intravenously weekly until documented progression of disease, unacceptable toxicity, or end of study.|Participants will receive daratumumab 1800 mg by SC injection on Days 1, 8, 15 and 22 of Cycles 1 and 2 (each cycle is of 28 days) then on Day 1 and 15 of Cycles 3 to 6 and on Day 1 of Cycle 7 and thereafter until documented progression of disease, unacceptable toxicity, or end of study; Carfilzomib 20 mg/m^2 intravenously (IV) on Day 1 of Cycle 1 only then 70 mg/m^2 IV on Days 8 and 15 of Cycle 1 and Days 1, 8 and 15 of Cycle 2 and thereafter until documented progression of disease, unacceptable toxicity, or end of study and dexamethasone 40 mg orally or IV weekly for Cycles 1-9 then on Days 1, 8, 15 of each cycle for Cycles 10 and thereafter until documented progression of disease, unacceptable toxicity, or end of study.","Drug","Daratumumab|Bortezomib|Lenalidomide|Dexamethasone|Melphalan|Prednisone|Carfilzomib","Daratumumab will be administered at a dose of 1800 mg by SC injection in Cycles 1 to 4 in D-VRd cohort and until documented progression of disease, unacceptable toxicity, or end of study for D-VMP, D-Rd and D-Kd cohorts.|Bortezomib will be administered as 1.3 mg/m^2 SC injection in Cycles 1 to 4 in D-VRd cohort and in Cycles 1 to 9 in D-VMP cohort.|Lenalidomide will be administered as 25 mg capsule orally in Cycles 1 to 4 in D-VRd cohort and in all Cycles until documented progression of disease, unacceptable toxicity, or end of study in D-Rd cohort.|Dexamethasone will be administered as 20 mg orally or intravenously in Cycles 1 to 4 in D-VRd cohort; 40 mg orally or intravenously in all cycles and thereafter until documented progression of disease, unacceptable toxicity, or end of study in D-Rd and D-Kd cohort.|Melphalan will be administered as 9 mg/m^2 orally in Cycles 1 to 9.|Prednisone will be administered as 60 mg/m^2 orally in cycles 1 to 9.|Carfilzomib will be administered as 20 mg/m^2 IV on Day 1 of Cycle 1 only then 70 mg/m^2 IV on Days 8 and 15 of Cycle 1 and Days 1, 8 and 15 of Cycle 2 and thereafter until documented progression of disease, unacceptable toxicity, or end of study in D-Kd cohort.",null,"Daratumumab(D)+Bortezomib+Lenalidomide+Dexamethasone (D-VRd)|D + Bortezomib + Melphalan + Prednisone (D-VMP)|Daratumumab + Lenalidomide + Dexamethasone (D-Rd)|Daratumumab + Carfilzomib + Dexamethasone (D-Kd)","\n\n * Multiple myeloma diagnosed according to the International Myeloma Working Group (IMWG) diagnostic criteria\n * Measurable, secretory disease as defined by any of the following: 1. Serum monoclonal paraprotein (M-protein) level greater than or equal to (>=) 1.0 gram per deciliter (g/dL); or\n    2. Urine M-protein level >= 200 milligram per 24 hours (mg/24 hours); or\n    3. Light chain multiple myeloma (MM), for participants without measurable disease in the serum or urine: serum Immunoglobulin (Ig) free light chain (FLC) >= 10 mg/dL and abnormal FLC ratio\n   \n   \n * Meets one of the sets of the following criteria: 1. For Daratumumab + bortezomib + lenalidomide + dexamethasone (D-VRd) and Daratumumab + bortezomib + melphalan + prednisone + dexamethasone (D-VMP) regimen: newly diagnosed myeloma\n    2. For Daratumumab + lenalidomide + dexamethasone (D-Rd) and Daratumumab + Carfilzomib + Dexamethasone (D-Kd) regimen: relapsed or refractory disease\n    3. D-Kd cohort: Participants must have received only 1 prior line of therapy for MM which included at least 2 consecutive cycles of lenalidomide therapy\n   \n   \n * Eastern Cooperative Oncology Group (ECOG) Performance Status grade of 0, 1, or 2\n * During the study, and for 3 months after receiving the last dose of daratumumab, a woman must agree not to donate eggs (ova, oocytes) and men must agree not to donate sperm for the purposes of assisted reproduction\n\n","\n\n * History of malignancy (other than MM) unless all treatment of that malignancy was completed at least 2 years before consent and the participant has no evidence of disease further exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or breast, or other non-invasive lesion, that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence within 3 years\n * Exhibits clinical signs of meningeal involvement of MM\n * Either of the following: a) Chronic obstructive pulmonary disease with a forced expiratory volume in 1 second (FEV1) is less than (<) 50 percentage (%) of predicted normal b) Moderate or severe persistent asthma, or a history of asthma within the last 2 years, or currently has uncontrolled asthma of any classification c) For D-Kd cohort: Known infiltrative pulmonary disease or known pulmonary hypertension\n * Any of the following: a) Known to be seropositive for human immunodeficiency virus; b) Seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen [HBsAg]). Participants with resolved infection (participants who are HBsAg negative but positive for antibodies to hepatitis B core antigen [Anti-HBc] and/or antibodies to hepatitis B surface antigen [Anti-HBs]) must be screened using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) DNA levels. Those who are polymerase chain reaction (PCR) positive will be excluded\n * Known to be seropositive for hepatitis C (Anti-HCV antibody positive or HCV-RNA quantitation positive) except in the setting of a sustained virologic response [SVR], defined as aviremia at least 12 weeks after completion of antiviral therapy\n * For D-Kd cohort only: Transthoracic echocardiogram showing left ventricular ejection fraction (LVEF) <40%; uncontrolled hypertension, defined as an average systolic blood pressure greater than (>)159 millimeters of mercury (mmHg) or diastolic >99 mmHg despite optimal treatment",{"$nulls":4},"Actual","2018-01-26","Actual","Anticipated","2021-11-26","Anticipated","2020-01-01","2018-01-22","2018-01-22","2020-01-30","No",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Non-Randomized","18 Years",null,"All",null,"No",null,null,"URL: http://pam.sylogent.com/cr/CR108435 [http://pam.sylogent.com/cr/CR108435] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To learn how to participate in this trial please click here.",null,"Yes","No",{"$nulls":17},"2017-004203-41|54767414MMY2040","EudraCT Number|Janssen Research & Development, LLC","D-VMP, D-Kd, and D-Rd Cohort: Overall Response Rate (ORR)|D-VRd Cohort: Very Good Partial Response (VGPR) or Better Rate","The ORR is defined as the percentage of participants who achieve partial response (PR) or better according to international myeloma working group (IMWG) criteria, during or after study treatment for D-VMP, D-Kd and D-Rd cohorts. IMWG criteria for PR: greater than or equal to (>=) 50 percent (%) reduction of serum M-protein and reduction in 24-hour urinary M-protein by >=90% or to less than (<) 200 mg/24 hours, If the serum and urine M-protein are not measurable, a decrease of >=50% in the difference between involved and uninvolved free light chain (FLC) levels is required in place of the M-protein criteria, If serum and urine M-protein are not measurable, and serum free light assay is also not measurable, >=50% reduction in bone marrow plasma cells (PCs) is required in place of M-protein, provided baseline bone marrow plasma cell percentage was >=30%. In addition to the above criteria, if present at baseline, a >=50% reduction in the size of soft tissue plasmacytomas is also required.|The VGPR or better rate, defined as the percentage of participants achieving VGPR or better according IMWG criteria during or after the study treatment in Daratumumab + Bortezomib + Lenalidomide + Dexamethasone (D-VRd) cohort. IMWG criteria for VGPR: Serum and urine M-component detectable by immunofixation but not on electrophoresis, or >= 90 percent (%) reduction in serum M-protein plus urine M-protein <100 milligram per 24 hours (mg/24 hours).","18 months after the last participant enrolled (approximately 2.5 years)","Maximum Observed Serum Concentrations (Cmax) of Daratumumab|Minimum Observed Serum Concentrations (Cmin) of Daratumumab|Percentage of Participants with Infusion-Related Reactions (IRR)|D-Kd, D-VMP, and D-Rd Cohort: Very Good Partial Response (VGPR) or Better Rate|D-VRd Cohort: Overall Response Rate (ORR)|Complete Response or Better Rate|Duration of Response (DOR)|Number of Participants with Anti-Drug Antibodies Against Daratumumab or Recombinant Human Hyaluronidase (rHuPH20)|D-Kd, D-VMP, and D-Rd Cohorts: Percentage of Participants who are Minimal Residual Disease (MRD) Negative","Cmax is defined as maximum concentration observed following daratumumab administration.|Cmin is defined as the minimum concentration observed immediately before daratumumab administration.|The Percentage of Participants with infusion reactions will be reported.|The VGPR or better rate, defined as the percentage of participants achieving VGPR or better rate according IMWG criteria during or after the study treatment for Daratumumab + Carfilzomib + Dexamethasone (D-Kd), Daratumumab + Bortezomib + Melphalan + Prednisone (D-VMP), and Daratumumab + Lenalidomide + Dexamethasone (D-Rd) cohorts. IMWG criteria for VGPR: Serum and urine M-component detectable by immunofixation but not on electrophoresis, or greater than equal to (>=) 90 percent (%) reduction in serum M-protein plus urine M-protein <100 milligram (mg)/24 hours.|The ORR is defined as the proportion of participants who achieve partial response (PR) or better according to IMWG criteria, during or after study treatment for D-VRd cohort. IMWG criteria for PR: greater than or equal to (>=) 50 percent (%) reduction of serum M-protein and reduction in 24-hour urinary M-protein by >=90% or to less than (<) 200 mg/24 hours, If the serum and urine M-protein are not measurable, a decrease of >=50% in the difference between involved and uninvolved free light chain (FLC) levels is required in place of the M-protein criteria, If serum and urine M-protein are not measurable, and serum free light assay is also not measurable, >=50% reduction in bone marrow plasma cells (PCs) is required in place of M-protein, provided baseline bone marrow plasma cell percentage was >=30%. In addition to the above criteria, if present at baseline, a >=50% reduction in the size of soft tissue plasmacytomas is also required.|Complete response is based on serum M-Protein assessments. IMWG criteria for CR: Negative immunofixation on the serum and urine, and disappearance of any soft tissue plasmacytomas, and <5% PCs in bone marrow. Stringent complete response (sCR): CR plus normal FLC ratio, and absence of clonal PCs by immunohistochemistry, immunofluorescence or 2- to 4 color flow cytometry.|Duration of response is defined as the time from the date of initial documented response (PR or better for D-Kd, D-VMP, D-Rd, and D-VRd cohorts) to the date of first documented evidence of progressive disease or death due to progressive disease (PD).|Participants with anti-drug antibodies against daratumumab or rHuPH20 will be analyzed.|Percentage of participants who are MRD negative will be assessed for D-Kd, D-VMP, and D-Rd cohorts. MRD negative is defined as less than (<) 0.01% abnormal population counts to total event counts when measured by flow.","D-VRd: Day 4 of Cycles 1 and 4 and post treatment 4 weeks and at week 8; D-VMP and D-Rd: Day 4 of Cycles 1 and 2 and post treatment 4 weeks and at week 8; D-Kd: Day 4 of Cycles 1 and 3 and post treatment 4 weeks and at week 8|D-VRd: predose on Day 1 of Cycles 1, 3, and 4; D-VMP: predose on Day 1 of Cycles 1, 2, 3, 6 and 9; D-Rd: predose on Day 1 of Cycles 1, 3, 6, 9 and 12 and D-Kd: predose on Day 1 of Cycles 1, 3, 6, 9, and 12|18 months after the last participant enrolled (approximately 2.5 years)|Up to 8 weeks after the last dose of study drug (approximately 1 year)","JNJ.CT@sylogent.com","Study Contact","844-434-4210","Fortaleza, Brazil, 60430-230 Liga Norte Riograndense Contra O Cancer[Active, Not Recruiting]Natal, Brazil, 59075-740 Centro De Pesquisa Do Instituto Do CÃ¢ncer- Hospital SÃ£o Vicente De PauloPasso Fundo, Brazil, 99010-090 Hospital MÃ£e De Deus CenterPorto Alegre, Brazil, 90470-340 Instituto Nacional Do Cancer - IncaRio De Janeiro, Brazil, 20230-130 Universidade Federal De Sao Paulo[Active, Not Recruiting]Sao Paulo, Brazil, 04037-002 Hospital Do Servidor Publico Estadual - IamspeSao Paulo, Brazil Clinica Sao Germano[Active, Not Recruiting]SÃ£o Paulo, Brazil, 01455-010|[Active, Not Recruiting]Brno, Czechia, 625 00 Fakultni Nemocnice Hradec Kralove[Active, Not Recruiting]Hradec Kralove, Czechia, 500 05 Fakultni Nemocnice Ostrava[Active, Not Recruiting]Ostrava, Czechia, 70852 Vseobecna Fakultni Nemocnice V Praze - I. Interni Klinika - Klinika HematologiePraha 2, Czechia, 128 08|Nantes Cedex 1, France, 44093 Chu De Bordeaux - HÃ´pital Haut-LÃ©vÃªquePessac Cedex, France, 33604 Centre Hospitalier Lyon-SudPierre-BÃ©nite, France, 69495 Chu BretonneauTours Cedex 9, France, 37044 Chu Nancy BraboisVandoeuvre Les Nancy, France, 54511|Chemnitz, Germany, 09113 Universitaetsklinikum Hamburg EppendorfHamburg, Germany, 20246 Asklepios Klinik AltonaHamburg, Germany, 22763 Universitaetsklinikum HeidelbergHeidelberg, Germany, 69120 Universitaetsklinikum Tuebingen Der Eberhard-Karls-Universitaet, Abteilung Fuer Innere Medizin Ii,TÃ¼bingen, Germany, 72076|[Active, Not Recruiting]Haifa, Israel, 31096 Carmel Medical Center[Active, Not Recruiting]Haifa, Israel, 3436212 Hadassah Medical CenterJerusalem, Israel, 9112001 Galilee Medical Center[Active, Not Recruiting]Nahariya, Israel, 22100 Sheba Medical Center[Active, Not Recruiting]Ramat Gan, Israel, 52621 Tel-Aviv Sourasky Medical Center[Active, Not Recruiting]Tel-Aviv, Israel, 64239|[Active, Not Recruiting]Kanazawa, Japan, 920-8641 Matsuyama Red Cross HospitalMatsuyama, Japan, 790-8524 Nagoya City University Hospital[Active, Not Recruiting]Nagoya, Japan, 467-8602 Japanese Red Cross Central Medical Center[Active, Not Recruiting]Shibuya, Japan, 150-8935 Korea, Republic Of Keimyung University Dongsan HospitalDaegu, Korea, Republic Of, 700-712 Yeungnam University Medical CenterDaegu, Korea, Republic Of, 705-703 Chungnam National University HospitalDaejeon, Korea, Republic Of, 35015 Chonnam National University Hwasun HospitalHwasun Gun, Korea, Republic Of, 58128 Seoul National University Bundang HospitalSeongnam-Si, Korea, Republic Of, 13620 Korea Cancer Center HospitalSeoul, Korea, Republic Of, 01812 Seoul National University HospitalSeoul, Korea, Republic Of, 03080|[Active, Not Recruiting]Badalona, Spain, 08916 Hosp. Clinic I Provincial De Barcelona[Active, Not Recruiting]Barcelona, Spain, 08036 Inst. Cat. Doncologia-H Duran I Reynals[Active, Not Recruiting]Barcelona, Spain, 08908 Hosp. Univ. Vall D'HebronBarcelona, Spain, 8035 Hosp. Gral. Univ. Gregorio MaraÃ±on[Active, Not Recruiting]Madrid, Spain, 28007 Clinica Univ. De Navarra[Active, Not Recruiting]Madrid, Spain, 28027 Hosp. Univ. Ramon Y Cajal[Active, Not Recruiting]Madrid, Spain, 28034 Hosp. Univ. 12 De OctubreMadrid, Spain, 28041 Hosp. Son Llatzer[Active, Not Recruiting]Mallorca, Spain, 07198 Clinica Univ. De Navarra[Active, Not Recruiting]Pamplona, Spain, 31008 Hosp. Clinico Univ. De Salamanca[Active, Not Recruiting]Salamanca, Spain, 37007 Hosp. Univ. Dr. Peset[Active, Not Recruiting]Valencia, Spain, 46017|[Active, Not Recruiting]Birmingham, United Kingdom, B9 5Ss Royal Bournemouth Hospital[Active, Not Recruiting]Bournemouth, United Kingdom, Bh7 7Dw Kent And Canterbury Hospital[Active, Not Recruiting]Canterbury, United Kingdom, Ct1 3Ng Manchester Royal InfirmaryManchester, United Kingdom, M13 9Wl Derriford Hospital[Active, Not Recruiting]Plymouth, United Kingdom, Pl6 8Dh Royal Stoke University Hospital[Active, Not Recruiting]Stoke On Trent, United Kingdom, St4 6Qg|Farmington, Connecticut, United States, 06030 Cancer Center Of Central Connecticut - SouthingtonSouthington, Connecticut, United States, 06489-3237|Jacksonville, Florida, United States, 32224 Watson Clinic LlpLakeland, Florida, United States, 33805 Uf Health Cancer Center At Orlando HealthOrlando, Florida, United States, 32806|Iowa City, Iowa, United States, 52242|Baltimore, Maryland, United States, 21201|Detroit, Michigan, United States, 48201 Providence Cancer CenterSouthfield, Michigan, United States, 48075|Billings, Montana, United States, 59101|Lincoln, Nebraska, United States, 68506 Southeast Nebraska Cancer CenterLincoln, Nebraska, United States, 68510 Nebraska Cancer SpecialistsOmaha, Nebraska, United States, 68130 University Of Nebraska Medical CenterOmaha, Nebraska, United States, 68198|Ridgewood, New Jersey, United States, 07450|Farmington, New|East Hills, New York, United States, 11548 Queens Medical Associates, PcFresh Meadows, New York, United States, 11366 Northwell HealthLake Success, New York, United States, 11042 Nyu WinthropMineola, New York, United States, 11501 Mt. Sinai School Of MedicineNew York, New York, United States, 10029|Chapel Hill, North Carolina, United States, 27599 Wake Forest University Baptist Medical Center (Wfubmc) - Comprehensive Cancer CenterWinston-Salem, North Carolina, United States, 27157|Spartanburg, South Carolina, United States, 29303|Sioux Falls, South Dakota, United States, 57105|Salt Lake City, Utah, United States, 84121|Charlottesville, Virginia, United States, 22903|Seattle, Washington, United States, 98101","Connecticut|Florida|Iowa|Maryland|Michigan|Montana|Nebraska|New Jersey|New Mexico|New York|North Carolina|South Carolina|South Dakota|Utah|Virginia|Washington","Brazil|Czechia|France|Germany|Israel|Japan|Spain|United Kingdom|United States","Instituto Do Cancer Do Ceara|Fakultni Nemocnice Brno|Chu De Nantes HÃ´tel-Dieu|Klinikum Chemnitz Ggmbh|Rambam Medical Center|Kanazawa University Hospital|Inst. Cat. D'Oncologia-Badalona|Heart Of England Nhs Foundation Trust|University Of Connecticut|Mayo Clinic In Florida|University Of Iowa Hospitals & Clinics|University Of Maryland|Karmonos Cancer Institute|Billings Clinic|Nebraska Hematology And Oncology|The Valley Hospital|San Juan Oncology Associates|St Francis Hospital|University Of North Carolina|Gibbs Cancer Center|Avera Medical Group - Oncology & Hematology|Utah Cancer Specialists|University Of Virginia Cancer Center - Emily Couric Clinical Cancer Center - Women's Oncology Clinic|Virginia Mason Medical Center",{"$nulls":3},"Janssen Research & Development, LLC Clinical Trial","2020-01-30","2020-05-25T16:38:53.826","2020-05-26T17:10:42.972","NCT03412565"]
["5ecbf49efeab101b15530999","NCT03412747","2018-01-31","UCB","UCBJF","Recruiting","A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis (BE SURE)","Bimekizumab|Adalimumab","IL17A Inhibitor|TNFa Inhibitor","Yes","['Bimekizumab', 'Adalimumab']","No",null,"Phase 3",3,450,"Anticipated","2018-01-26","2019-02-15","PASI","Psoriasis Area and Severity Index",{"$nulls":3},"This is a study to compare the efficacy of bimekizumab versus adalimumab in the treatment of subjects with moderate to severe chronic plaque psoriasis (PSO).",null,"A Phase 3, Multicenter, Randomized, Double-Blind Study With an Active-Controlled Initial Treatment Period Followed by a Dose-Blind Maintenance Treatment Period to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis","PS0008","Chronic Plaque Psoriasis\nModerate to Severe Plaque Psoriasis","Psoriasis","Dermatological Diseases","Derm & Connective Tissue Disorders","Experimental|Active Comparator","Bimekizumab Arm 1|Bimekizumab Arm 2|Adalimumab Arm","Subjects will receive bimekizumab dose regimen 1 for 56 weeks. Subjects will receive placebo at pre-specified time-points to maintain the blinding.|Subjects will receive bimekizumab dose regimen 1 for 16 weeks and will proceed with bimekizumab dose regimen 2 until week 56. Subjects will receive placebo at pre-specified time-points to maintain the blinding.|Subjects will receive adalimumab for 24 weeks and will then be re-randomized to receive bimekizumab dose regimen 1 until week 56. Subjects will receive placebo at pre-specified time-points to maintain the blinding.","Drug","Bimekizumab|Adalimumab","Subjects will receive bimekizumab at pre-defined timepoints in dose regimen 1 and/or dose regimen 2.|Adalimumab will be administered according to the labeling recommendations.","UCB4940\nPlaceboSubjects will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products (IMP).|UCB4940|HumiraÂ®\nPlaceboSubjects will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products (IMP).","Bimekizumab Arm 1|Bimekizumab Arm 2|Adalimumab Arm","\n\n * Must be at least 18 years of age\n * Chronic plaque PSO for at least 6 months prior to the Screening Visit\n * Psoriasis Area Severity Index (PASI) >=12 and body surface area (BSA) affected by PSO >=10% and Investigator's Global Assessment (IGA) score >=3 on a 5-point scale\n * Subject is a candidate for systemic PSO therapy\n * Female subject of child bearing potential must be willing to use highly effective method of contraception\n\n","\n\n * Subject has a known hypersensitivity to any excipients of bimekizumab or adalimumab\n * Subject has an active infection (except common cold), a serious infection, or a history of opportunistic or recurrent chronic infections\n * Subject has concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection\n * Subject has known tuberculosis (TB) infection, is at high risk of acquiring TB infection, or has current or history of nontuberculous mycobacterium (NTMB) infection\n * Subject has any other condition, including medical or psychiatric, which, in the Investigator's judgment, would make the subject unsuitable for inclusion in the study\n * Subject has had previous exposure to adalimumab\n * Presence of active suicidal ideation or severe depression\n * Subject has concurrent or a recent history (<5 years) of malignancy",{"$nulls":4},"Actual","2018-01-26","Actual","Anticipated","2020-03-14","Anticipated","2018-01-01","2018-01-22","2018-01-25","2018-01-30","Yes","Bimekizumab\nPSO\nPsoriasis","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"All",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2016-003392-22","EudraCT Number","Psoriasis Area and Severity Index 90 (PASI90) response at Week 16|Investigator's Global Assessment (IGA) response at Week 16","A PASI90 responder is defined as a subject that achieves 90% reduction from Baseline in the PASI score.|IGA response is defined as Clear or Almost Clear with at least a 2-category improvement relative to Baseline.","Week 16","PASI90 response at Week 24|IGA response at Week 24|PASI75 response at Week 4|PASI100 response at Week 16|PASI100 response at Week 24|PASI90 response at Week 56|IGA response at Week 56|Number of Treatment Emergent Adverse Events (TEAEs) adjusted by duration of subject exposure to study treatment|Number of Serious Adverse Events (SAEs) adjusted by duration of subject exposure to study treatment|Number of Treatment Emergent Adverse Events (TEAEs) leading to withdrawal adjusted by duration of subject exposure to study treatment","A PASI90 responder is defined as a subject that achieves 90% reduction from Baseline in the PASI score.|IGA response is defined as Clear or Almost Clear with at least 2-category improvement relative to Baseline.|A PASI75 responder is defined as a subject that achieves 75% reduction from Baseline in the PASI score.|A PASI100 responder is defined as a subject that achieves 100% reduction from Baseline in the PASI score.|The number of TEAEs adjusted by duration of exposure to study treatment is scaled such that it provides an incidence rate per 100 patient-years. If a subject has multiple events, the time of exposure is calculated to the first occurrence of the Adverse Event (AE) being considered. If a subject has no events, the total time at risk is used.|The number of adjusted SAEs by duration of exposure to study treatment is scaled such that it provides an incidence rate per 100 patient-years. If a subject has multiple events, the time of exposure is calculated to the first occurrence of the AE being considered. If a subject has no events, the total time at risk is used.|The number of TEAEs leading to discontinuation adjusted by duration of exposure to study treatment is scaled such that it provides an incidence rate per 100 patient-years. If a subject has multiple events, the time of exposure is calculated to the first occurrence of the AE being considered. If a subject has no events, the total time at risk is used.","Week 24|Week 4|Week 16|Week 56|From Screening to Safety Follow Up (up to Week 76)","UCBCares@ucb.com","UCB Cares","+1844599 Ext. 2273","Houston, Texas, United States, 77004","Texas","United States","Ps0008 924",{"$nulls":3},"UCB Cares","2018-01-30","2020-05-25T16:38:54.987","2020-05-26T17:10:42.972","NCT03412747"]
["5ecbf49ffe30261b1a04836b","NCT03412747","2018-02-07","UCB","UCBJF","Recruiting","A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis (BE SURE)","Bimekizumab|Adalimumab","IL17A Inhibitor|TNFa Inhibitor","Yes","['Bimekizumab', 'Adalimumab']","No",null,"Phase 3",3,450,"Anticipated","2018-01-26","2019-02-15","PASI","Psoriasis Area and Severity Index",{"$nulls":3},"This is a study to compare the efficacy of bimekizumab versus adalimumab in the treatment of subjects with moderate to severe chronic plaque psoriasis (PSO).",null,"A Phase 3, Multicenter, Randomized, Double-Blind Study With an Active-Controlled Initial Treatment Period Followed by a Dose-Blind Maintenance Treatment Period to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis","PS0008","Chronic Plaque Psoriasis\nModerate to Severe Plaque Psoriasis","Psoriasis","Dermatological Diseases","Derm & Connective Tissue Disorders","Experimental|Active Comparator","Bimekizumab Arm 1|Bimekizumab Arm 2|Adalimumab Arm","Subjects will receive bimekizumab dose regimen 1 for 56 weeks. Subjects will receive placebo at pre-specified time-points to maintain the blinding.|Subjects will receive bimekizumab dose regimen 1 for 16 weeks and will proceed with bimekizumab dose regimen 2 until week 56. Subjects will receive placebo at pre-specified time-points to maintain the blinding.|Subjects will receive adalimumab for 24 weeks and will then be re-randomized to receive bimekizumab dose regimen 1 until week 56. Subjects will receive placebo at pre-specified time-points to maintain the blinding.","Drug","Bimekizumab|Adalimumab","Subjects will receive bimekizumab at pre-defined timepoints in dose regimen 1 and/or dose regimen 2.|Adalimumab will be administered according to the labeling recommendations.","UCB4940\nPlaceboSubjects will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products (IMP).|UCB4940|HumiraÂ®\nPlaceboSubjects will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products (IMP).","Bimekizumab Arm 1|Bimekizumab Arm 2|Adalimumab Arm","\n\n * Must be at least 18 years of age\n * Chronic plaque PSO for at least 6 months prior to the Screening Visit\n * Psoriasis Area Severity Index (PASI) >=12 and body surface area (BSA) affected by PSO >=10% and Investigator's Global Assessment (IGA) score >=3 on a 5-point scale\n * Subject is a candidate for systemic PSO therapy\n * Female subject of child bearing potential must be willing to use highly effective method of contraception\n\n","\n\n * Subject has a known hypersensitivity to any excipients of bimekizumab or adalimumab\n * Subject has an active infection (except common cold), a serious infection, or a history of opportunistic or recurrent chronic infections\n * Subject has concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection\n * Subject has known tuberculosis (TB) infection, is at high risk of acquiring TB infection, or has current or history of nontuberculous mycobacterium (NTMB) infection\n * Subject has any other condition, including medical or psychiatric, which, in the Investigator's judgment, would make the subject unsuitable for inclusion in the study\n * Subject has had previous exposure to adalimumab\n * Presence of active suicidal ideation or severe depression\n * Subject has concurrent or a recent history (<5 years) of malignancy",{"$nulls":4},"Actual","2018-01-26","Actual","Anticipated","2020-03-14","Anticipated","2018-02-01","2018-01-22","2018-01-25","2018-02-06","Yes","Bimekizumab\nPSO\nPsoriasis","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"All",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2016-003392-22","EudraCT Number","Psoriasis Area and Severity Index 90 (PASI90) response at Week 16|Investigator's Global Assessment (IGA) response at Week 16","A PASI90 responder is defined as a subject that achieves 90% reduction from Baseline in the PASI score.|IGA response is defined as Clear or Almost Clear with at least a 2-category improvement relative to Baseline.","Week 16","PASI90 response at Week 24|IGA response at Week 24|PASI75 response at Week 4|PASI100 response at Week 16|PASI100 response at Week 24|PASI90 response at Week 56|IGA response at Week 56|Number of Treatment Emergent Adverse Events (TEAEs) adjusted by duration of subject exposure to study treatment|Number of Serious Adverse Events (SAEs) adjusted by duration of subject exposure to study treatment|Number of Treatment Emergent Adverse Events (TEAEs) leading to withdrawal adjusted by duration of subject exposure to study treatment","A PASI90 responder is defined as a subject that achieves 90% reduction from Baseline in the PASI score.|IGA response is defined as Clear or Almost Clear with at least 2-category improvement relative to Baseline.|A PASI75 responder is defined as a subject that achieves 75% reduction from Baseline in the PASI score.|A PASI100 responder is defined as a subject that achieves 100% reduction from Baseline in the PASI score.|The number of TEAEs adjusted by duration of exposure to study treatment is scaled such that it provides an incidence rate per 100 patient-years. If a subject has multiple events, the time of exposure is calculated to the first occurrence of the Adverse Event (AE) being considered. If a subject has no events, the total time at risk is used.|The number of adjusted SAEs by duration of exposure to study treatment is scaled such that it provides an incidence rate per 100 patient-years. If a subject has multiple events, the time of exposure is calculated to the first occurrence of the AE being considered. If a subject has no events, the total time at risk is used.|The number of TEAEs leading to discontinuation adjusted by duration of exposure to study treatment is scaled such that it provides an incidence rate per 100 patient-years. If a subject has multiple events, the time of exposure is calculated to the first occurrence of the AE being considered. If a subject has no events, the total time at risk is used.","Week 24|Week 4|Week 16|Week 56|From Screening to Safety Follow Up (up to Week 76)","UCBCares@ucb.com","UCB Cares","+1844599 Ext. 2273","Houston, Texas, United States, 77004","Texas","United States","Ps0008 924",{"$nulls":3},"UCB Cares","2018-02-06","2020-05-25T16:38:55.213","2020-05-26T17:10:42.972","NCT03412747"]
["5ecbf49f307e3d1b1f8d9dfc","NCT03412747","2018-04-13","UCB","UCBJF","Recruiting","A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis (BE SURE)","Bimekizumab|Adalimumab","IL17A Inhibitor|TNFa Inhibitor","Yes","['Bimekizumab', 'Adalimumab']","No",null,"Phase 3",3,450,"Anticipated","2018-01-26","2019-02-15","PASI","Psoriasis Area and Severity Index",{"$nulls":3},"This is a study to compare the efficacy of bimekizumab versus adalimumab in the treatment of subjects with moderate to severe chronic plaque psoriasis (PSO).",null,"A Phase 3, Multicenter, Randomized, Double-Blind Study With an Active-Controlled Initial Treatment Period Followed by a Dose-Blind Maintenance Treatment Period to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis","PS0008","Chronic Plaque Psoriasis\nModerate to Severe Plaque Psoriasis","Psoriasis","Dermatological Diseases","Derm & Connective Tissue Disorders","Experimental|Active Comparator","Bimekizumab Arm 1|Bimekizumab Arm 2|Adalimumab Arm","Subjects will receive bimekizumab dose regimen 1 for 56 weeks. Subjects will receive placebo at pre-specified time-points to maintain the blinding.|Subjects will receive bimekizumab dose regimen 1 for 16 weeks and will proceed with bimekizumab dose regimen 2 until week 56. Subjects will receive placebo at pre-specified time-points to maintain the blinding.|Subjects will receive adalimumab for 24 weeks and will then be re-randomized to receive bimekizumab dose regimen 1 until week 56. Subjects will receive placebo at pre-specified time-points to maintain the blinding.","Drug","Bimekizumab|Adalimumab","Subjects will receive bimekizumab at pre-defined timepoints in dose regimen 1 and/or dose regimen 2.|Adalimumab will be administered according to the labeling recommendations.","UCB4940\nPlaceboSubjects will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products (IMP).|UCB4940|HumiraÂ®\nPlaceboSubjects will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products (IMP).","Bimekizumab Arm 1|Bimekizumab Arm 2|Adalimumab Arm","\n\n * Must be at least 18 years of age\n * Chronic plaque PSO for at least 6 months prior to the Screening Visit\n * Psoriasis Area Severity Index (PASI) >=12 and body surface area (BSA) affected by PSO >=10% and Investigator's Global Assessment (IGA) score >=3 on a 5-point scale\n * Subject is a candidate for systemic PSO therapy\n * Female subject of child bearing potential must be willing to use highly effective method of contraception\n\n","\n\n * Subject has a known hypersensitivity to any excipients of bimekizumab or adalimumab\n * Subject has an active infection (except common cold), a serious infection, or a history of opportunistic or recurrent chronic infections\n * Subject has concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection\n * Subject has known tuberculosis (TB) infection, is at high risk of acquiring TB infection, or has current or history of nontuberculous mycobacterium (NTMB) infection\n * Subject has any other condition, including medical or psychiatric, which, in the Investigator's judgment, would make the subject unsuitable for inclusion in the study\n * Subject has had previous exposure to adalimumab\n * Presence of active suicidal ideation or severe depression\n * Subject has concurrent or a recent history (<5 years) of malignancy",{"$nulls":4},"Actual","2018-01-26","Actual","Anticipated","2020-03-14","Anticipated","2018-04-01","2018-01-22","2018-01-25","2018-04-12","Yes","Bimekizumab\nPSO\nPsoriasis","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"All",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2016-003392-22","EudraCT Number","Psoriasis Area and Severity Index 90 (PASI90) response at Week 16|Investigator's Global Assessment (IGA) response at Week 16","A PASI90 responder is defined as a subject that achieves 90% reduction from Baseline in the PASI score.|IGA response is defined as Clear or Almost Clear with at least a 2-category improvement relative to Baseline.","Week 16","PASI90 response at Week 24|IGA response at Week 24|PASI75 response at Week 4|PASI100 response at Week 16|PASI100 response at Week 24|PASI90 response at Week 56|IGA response at Week 56|Number of Treatment Emergent Adverse Events (TEAEs) adjusted by duration of subject exposure to study treatment|Number of Serious Adverse Events (SAEs) adjusted by duration of subject exposure to study treatment|Number of Treatment Emergent Adverse Events (TEAEs) leading to withdrawal adjusted by duration of subject exposure to study treatment","A PASI90 responder is defined as a subject that achieves 90% reduction from Baseline in the PASI score.|IGA response is defined as Clear or Almost Clear with at least 2-category improvement relative to Baseline.|A PASI75 responder is defined as a subject that achieves 75% reduction from Baseline in the PASI score.|A PASI100 responder is defined as a subject that achieves 100% reduction from Baseline in the PASI score.|The number of TEAEs adjusted by duration of exposure to study treatment is scaled such that it provides an incidence rate per 100 patient-years. If a subject has multiple events, the time of exposure is calculated to the first occurrence of the Adverse Event (AE) being considered. If a subject has no events, the total time at risk is used.|The number of adjusted SAEs by duration of exposure to study treatment is scaled such that it provides an incidence rate per 100 patient-years. If a subject has multiple events, the time of exposure is calculated to the first occurrence of the AE being considered. If a subject has no events, the total time at risk is used.|The number of TEAEs leading to discontinuation adjusted by duration of exposure to study treatment is scaled such that it provides an incidence rate per 100 patient-years. If a subject has multiple events, the time of exposure is calculated to the first occurrence of the AE being considered. If a subject has no events, the total time at risk is used.","Week 24|Week 4|Week 16|Week 56|From Screening to Safety Follow Up (up to Week 76)","UCBCares@ucb.com","UCB Cares","+1844599 Ext. 2273","San Diego, California, United States, 92123 Ps0008 943San Luis Obispo, California, United States, 93405|Danbury, Connecticut, United States, 06810|Tampa, Florida, United States, 33624|Overland Park, Kansas, United States, 66215|Brighton, Massachusetts, United States, 02135|Troy, Michigan, United States, 48084|East Windsor, New Jersey, United States, 08520|Houston, Texas, United States, 77004 Ps0008 951Houston, Texas, United States, 77004|Milwaukee, Wisconsin, United States, 53226","California|Connecticut|Florida|Kansas|Massachusetts|Michigan|New Jersey|Texas|Wisconsin","United States","Ps0008 955|Ps0008 939|Ps0008 936|Ps0008 905|Ps0008 925|Ps0008 917|Ps0008 908|Ps0008 924|Ps0008 938",{"$nulls":3},"UCB Cares","2018-04-12","2020-05-25T16:38:55.662","2020-05-26T17:10:42.972","NCT03412747"]
["5ecbf49fe2561b1b11905e65","NCT03412747","2018-05-11","UCB","UCBJF","Recruiting","A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis (BE SURE)","Bimekizumab|Adalimumab","IL17A Inhibitor|TNFa Inhibitor","Yes","['Bimekizumab', 'Adalimumab']","No",null,"Phase 3",3,450,"Anticipated","2018-01-26","2019-02-15","PASI","Psoriasis Area and Severity Index",{"$nulls":3},"This is a study to compare the efficacy of bimekizumab versus adalimumab in the treatment of subjects with moderate to severe chronic plaque psoriasis (PSO).",null,"A Phase 3, Multicenter, Randomized, Double-Blind Study With an Active-Controlled Initial Treatment Period Followed by a Dose-Blind Maintenance Treatment Period to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis","PS0008","Chronic Plaque Psoriasis\nModerate to Severe Plaque Psoriasis","Psoriasis","Dermatological Diseases","Derm & Connective Tissue Disorders","Experimental|Active Comparator","Bimekizumab Arm 1|Bimekizumab Arm 2|Adalimumab Arm","Subjects will receive bimekizumab dose regimen 1 for 56 weeks. Subjects will receive placebo at pre-specified time-points to maintain the blinding.|Subjects will receive bimekizumab dose regimen 1 for 16 weeks and will proceed with bimekizumab dose regimen 2 until week 56. Subjects will receive placebo at pre-specified time-points to maintain the blinding.|Subjects will receive adalimumab for 24 weeks and will then be re-randomized to receive bimekizumab dose regimen 1 until week 56. Subjects will receive placebo at pre-specified time-points to maintain the blinding.","Drug","Bimekizumab|Adalimumab","Subjects will receive bimekizumab at pre-defined timepoints in dose regimen 1 and/or dose regimen 2.|Adalimumab will be administered according to the labeling recommendations.","UCB4940\nPlaceboSubjects will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products (IMP).|UCB4940|HumiraÂ®\nPlaceboSubjects will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products (IMP).","Bimekizumab Arm 1|Bimekizumab Arm 2|Adalimumab Arm","\n\n * Must be at least 18 years of age\n * Chronic plaque PSO for at least 6 months prior to the Screening Visit\n * Psoriasis Area Severity Index (PASI) >=12 and body surface area (BSA) affected by PSO >=10% and Investigator's Global Assessment (IGA) score >=3 on a 5-point scale\n * Subject is a candidate for systemic PSO therapy\n * Female subject of child bearing potential must be willing to use highly effective method of contraception\n\n","\n\n * Subject has a known hypersensitivity to any excipients of bimekizumab or adalimumab\n * Subject has an active infection (except common cold), a serious infection, or a history of opportunistic or recurrent chronic infections\n * Subject has concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection\n * Subject has known tuberculosis (TB) infection, is at high risk of acquiring TB infection, or has current or history of nontuberculous mycobacterium (NTMB) infection\n * Subject has any other condition, including medical or psychiatric, which, in the Investigator's judgment, would make the subject unsuitable for inclusion in the study\n * Subject has had previous exposure to adalimumab\n * Presence of active suicidal ideation or severe depression\n * Subject has concurrent or a recent history (<5 years) of malignancy",{"$nulls":4},"Actual","2018-01-26","Actual","Anticipated","2020-03-14","Anticipated","2018-05-01","2018-01-22","2018-01-25","2018-05-10","Yes","Bimekizumab\nPSO\nPsoriasis","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"All",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2016-003392-22","EudraCT Number","Psoriasis Area and Severity Index 90 (PASI90) response at Week 16|Investigator's Global Assessment (IGA) response at Week 16","A PASI90 responder is defined as a subject that achieves 90% reduction from Baseline in the PASI score.|IGA response is defined as Clear or Almost Clear with at least a 2-category improvement relative to Baseline.","Week 16","PASI90 response at Week 24|IGA response at Week 24|PASI75 response at Week 4|PASI100 response at Week 16|PASI100 response at Week 24|PASI90 response at Week 56|IGA response at Week 56|Number of Treatment Emergent Adverse Events (TEAEs) adjusted by duration of subject exposure to study treatment|Number of Serious Adverse Events (SAEs) adjusted by duration of subject exposure to study treatment|Number of Treatment Emergent Adverse Events (TEAEs) leading to withdrawal adjusted by duration of subject exposure to study treatment","A PASI90 responder is defined as a subject that achieves 90% reduction from Baseline in the PASI score.|IGA response is defined as Clear or Almost Clear with at least 2-category improvement relative to Baseline.|A PASI75 responder is defined as a subject that achieves 75% reduction from Baseline in the PASI score.|A PASI100 responder is defined as a subject that achieves 100% reduction from Baseline in the PASI score.|The number of TEAEs adjusted by duration of exposure to study treatment is scaled such that it provides an incidence rate per 100 patient-years. If a subject has multiple events, the time of exposure is calculated to the first occurrence of the Adverse Event (AE) being considered. If a subject has no events, the total time at risk is used.|The number of adjusted SAEs by duration of exposure to study treatment is scaled such that it provides an incidence rate per 100 patient-years. If a subject has multiple events, the time of exposure is calculated to the first occurrence of the AE being considered. If a subject has no events, the total time at risk is used.|The number of TEAEs leading to discontinuation adjusted by duration of exposure to study treatment is scaled such that it provides an incidence rate per 100 patient-years. If a subject has multiple events, the time of exposure is calculated to the first occurrence of the AE being considered. If a subject has no events, the total time at risk is used.","Week 24|Week 4|Week 16|Week 56|From Screening to Safety Follow Up (up to Week 76)","UCBCares@ucb.com","UCB Cares","+1844599 Ext. 2273","Peterborough, Canada Ps0008 662Toronto, Canada|Glendale, Arizona, United States, 85308|San Diego, California, United States, 92123 Ps0008 943San Luis Obispo, California, United States, 93405|Danbury, Connecticut, United States, 06810|Tampa, Florida, United States, 33624|Overland Park, Kansas, United States, 66215|Brighton, Massachusetts, United States, 02135|Troy, Michigan, United States, 48084|East Windsor, New Jersey, United States, 08520|Portland, Oregon, United States, 97223|Dallas, Texas, United States, 75231 Ps0008 924Houston, Texas, United States, 77004 Ps0008 951Houston, Texas, United States, 77004|Milwaukee, Wisconsin, United States, 53226","Arizona|California|Connecticut|Florida|Kansas|Massachusetts|Michigan|New Jersey|Oregon|Texas|Wisconsin","Canada|United States","Ps0008 661|Ps0008 857|Ps0008 955|Ps0008 939|Ps0008 936|Ps0008 905|Ps0008 925|Ps0008 917|Ps0008 908|Ps0008 929|Ps0008 931|Ps0008 938",{"$nulls":3},"UCB Cares","2018-05-10","2020-05-25T16:38:55.611","2020-05-26T17:10:42.972","NCT03412747"]
["5ecbf49ffe30261b1a04836c","NCT03412747","2018-06-25","UCB","UCBJF","Recruiting","A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis (BE SURE)","Bimekizumab|Adalimumab","IL17A Inhibitor|TNFa Inhibitor","Yes","['Bimekizumab', 'Adalimumab']","No",null,"Phase 3",3,450,"Anticipated","2018-01-26","2019-02-15","PASI","Psoriasis Area and Severity Index",{"$nulls":3},"This is a study to compare the efficacy of bimekizumab versus adalimumab in the treatment of subjects with moderate to severe chronic plaque psoriasis (PSO).",null,"A Phase 3, Multicenter, Randomized, Double-Blind Study With an Active-Controlled Initial Treatment Period Followed by a Dose-Blind Maintenance Treatment Period to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis","PS0008","Chronic Plaque Psoriasis\nModerate to Severe Plaque Psoriasis","Psoriasis","Dermatological Diseases","Derm & Connective Tissue Disorders","Experimental|Active Comparator","Bimekizumab Arm 1|Bimekizumab Arm 2|Adalimumab Arm","Subjects will receive bimekizumab dose regimen 1 for 56 weeks. Subjects will receive placebo at pre-specified time-points to maintain the blinding.|Subjects will receive bimekizumab dose regimen 1 for 16 weeks and will proceed with bimekizumab dose regimen 2 until week 56. Subjects will receive placebo at pre-specified time-points to maintain the blinding.|Subjects will receive adalimumab for 24 weeks and will then be re-randomized to receive bimekizumab dose regimen 1 until week 56. Subjects will receive placebo at pre-specified time-points to maintain the blinding.","Drug","Bimekizumab|Adalimumab","Subjects will receive bimekizumab at pre-defined timepoints in dose regimen 1 and/or dose regimen 2.|Adalimumab will be administered according to the labeling recommendations.","UCB4940\nPlaceboSubjects will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products (IMP).|UCB4940|HumiraÂ®\nPlaceboSubjects will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products (IMP).","Bimekizumab Arm 1|Bimekizumab Arm 2|Adalimumab Arm","\n\n * Must be at least 18 years of age\n * Chronic plaque PSO for at least 6 months prior to the Screening Visit\n * Psoriasis Area Severity Index (PASI) >=12 and body surface area (BSA) affected by PSO >=10% and Investigator's Global Assessment (IGA) score >=3 on a 5-point scale\n * Subject is a candidate for systemic PSO therapy\n * Female subject of child bearing potential must be willing to use highly effective method of contraception\n\n","\n\n * Subject has a known hypersensitivity to any excipients of bimekizumab or adalimumab\n * Subject has an active infection (except common cold), a serious infection, or a history of opportunistic or recurrent chronic infections\n * Subject has concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection\n * Subject has known tuberculosis (TB) infection, is at high risk of acquiring TB infection, or has current or history of nontuberculous mycobacterium (NTMB) infection\n * Subject has any other condition, including medical or psychiatric, which, in the Investigator's judgment, would make the subject unsuitable for inclusion in the study\n * Subject has had previous exposure to adalimumab\n * Presence of active suicidal ideation or severe depression\n * Subject has concurrent or a recent history (<5 years) of malignancy",{"$nulls":4},"Actual","2018-01-26","Actual","Anticipated","2020-03-14","Anticipated","2018-05-01","2018-01-22","2018-01-25","2018-06-21","Yes","Bimekizumab\nPSO\nPsoriasis","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"All",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2016-003392-22","EudraCT Number","Psoriasis Area and Severity Index 90 (PASI90) response at Week 16|Investigator's Global Assessment (IGA) response at Week 16","A PASI90 responder is defined as a subject that achieves 90% reduction from Baseline in the PASI score.|IGA response is defined as Clear or Almost Clear with at least a 2-category improvement relative to Baseline.","Week 16","PASI90 response at Week 24|IGA response at Week 24|PASI75 response at Week 4|PASI100 response at Week 16|PASI100 response at Week 24|PASI90 response at Week 56|IGA response at Week 56|Number of Treatment Emergent Adverse Events (TEAEs) adjusted by duration of subject exposure to study treatment|Number of Serious Adverse Events (SAEs) adjusted by duration of subject exposure to study treatment|Number of Treatment Emergent Adverse Events (TEAEs) leading to withdrawal adjusted by duration of subject exposure to study treatment","A PASI90 responder is defined as a subject that achieves 90% reduction from Baseline in the PASI score.|IGA response is defined as Clear or Almost Clear with at least 2-category improvement relative to Baseline.|A PASI75 responder is defined as a subject that achieves 75% reduction from Baseline in the PASI score.|A PASI100 responder is defined as a subject that achieves 100% reduction from Baseline in the PASI score.|The number of TEAEs adjusted by duration of exposure to study treatment is scaled such that it provides an incidence rate per 100 patient-years. If a subject has multiple events, the time of exposure is calculated to the first occurrence of the Adverse Event (AE) being considered. If a subject has no events, the total time at risk is used.|The number of adjusted SAEs by duration of exposure to study treatment is scaled such that it provides an incidence rate per 100 patient-years. If a subject has multiple events, the time of exposure is calculated to the first occurrence of the AE being considered. If a subject has no events, the total time at risk is used.|The number of TEAEs leading to discontinuation adjusted by duration of exposure to study treatment is scaled such that it provides an incidence rate per 100 patient-years. If a subject has multiple events, the time of exposure is calculated to the first occurrence of the AE being considered. If a subject has no events, the total time at risk is used.","Week 24|Week 4|Week 16|Week 56|From Screening to Safety Follow Up (up to Week 76)","UCBCares@ucb.com","UCB Cares","+1844599 Ext. 2273","Mississauga, Canada Ps0008 661Peterborough, Canada Ps0008 662Toronto, Canada Ps0008 664Toronto, Canada Ps0008 657Waterloo, Canada Ps0008 669Windsor, Canada Ps0008 670Windsor, Canada Ps0008 674Winnipeg, Canada|Mahlow, Germany|Budapest, Hungary Ps0008 256Debrecen, Hungary|WrocÅ‚aw, Poland|Glendale, Arizona, United States, 85308 Ps0008 957Glendale, Arizona, United States, 85308|San Diego, California, United States, 92123 Ps0008 943San Luis Obispo, California, United States, 93405|Danbury, Connecticut, United States, 06810|Boca Raton, Florida, United States, 33486 Ps0008 936Tampa, Florida, United States, 33624|West Des Moines, Iowa, United States, 50265|Overland Park, Kansas, United States, 66215|Beverly, Massachusetts, United States, 01844 Ps0008 925Brighton, Massachusetts, United States, 02135|Troy, Michigan, United States, 48084|East Windsor, New Jersey, United States, 08520|Portland, Oregon, United States, 97223|Dallas, Texas, United States, 75231 Ps0008 924Houston, Texas, United States, 77004 Ps0008 951Houston, Texas, United States, 77004|Milwaukee, Wisconsin, United States, 53226","Arizona|California|Connecticut|Florida|Iowa|Kansas|Massachusetts|Michigan|New Jersey|Oregon|Texas|Wisconsin","Canada|Germany|Hungary|Poland|United States","Ps0008 663|Ps0008 213|Ps0008 255|Ps0008 367|Ps0008 857|Ps0008 955|Ps0008 939|Ps0008 906|Ps0008 900|Ps0008 905|Ps0008 940|Ps0008 917|Ps0008 908|Ps0008 929|Ps0008 931|Ps0008 938",{"$nulls":3},"UCB Cares","2018-06-21","2020-05-25T16:38:55.922","2020-05-26T17:10:42.972","NCT03412747"]
["5ecbf4a0e2561b1b11905e66","NCT03412747","2018-07-20","UCB","UCBJF","Recruiting","A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis (BE SURE)","Bimekizumab|Adalimumab","IL17A Inhibitor|TNFa Inhibitor","Yes","['Bimekizumab', 'Adalimumab']","No",null,"Phase 3",3,450,"Anticipated","2018-01-26","2019-02-01","PASI","Psoriasis Area and Severity Index",{"$nulls":3},"This is a study to compare the efficacy of bimekizumab versus adalimumab in the treatment of subjects with moderate to severe chronic plaque psoriasis (PSO).",null,"A Phase 3, Multicenter, Randomized, Double-Blind Study With an Active-Controlled Initial Treatment Period Followed by a Dose-Blind Maintenance Treatment Period to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis","PS0008","Chronic Plaque Psoriasis\nModerate to Severe Plaque Psoriasis","Psoriasis","Dermatological Diseases","Derm & Connective Tissue Disorders","Experimental|Active Comparator","Bimekizumab Arm 1|Bimekizumab Arm 2|Adalimumab Arm","Subjects will receive bimekizumab dose regimen 1 for 56 weeks. Subjects will receive placebo at pre-specified time-points to maintain the blinding.|Subjects will receive bimekizumab dose regimen 1 for 16 weeks and will proceed with bimekizumab dose regimen 2 until week 56. Subjects will receive placebo at pre-specified time-points to maintain the blinding.|Subjects will receive adalimumab for 24 weeks and will then receive bimekizumab dose regimen 1 until week 56. Subjects will receive placebo at pre-specified time-points to maintain the blinding.","Drug","Bimekizumab|Adalimumab","Subjects will receive bimekizumab at pre-defined timepoints in dose regimen 1 and/or dose regimen 2.|Adalimumab will be administered according to the labeling recommendations.","UCB4940\nPlaceboSubjects will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products (IMP).|UCB4940|HumiraÂ®\nPlaceboSubjects will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products (IMP).","Bimekizumab Arm 1|Bimekizumab Arm 2|Adalimumab Arm","\n\n * Must be at least 18 years of age\n * Chronic plaque PSO for at least 6 months prior to the Screening Visit\n * Psoriasis Area Severity Index (PASI) >=12 and body surface area (BSA) affected by PSO >=10% and Investigator's Global Assessment (IGA) score >=3 on a 5-point scale\n * Subject is a candidate for systemic PSO therapy and/or phototherapy\n * Female subject of child bearing potential must be willing to use highly effective method of contraception\n\n","\n\n * Subject has a known hypersensitivity to any excipients of bimekizumab or adalimumab\n * Subject has an active infection (except common cold), a serious infection, or a history of opportunistic or recurrent chronic infections\n * Subject has concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection\n * Subject has known tuberculosis (TB) infection, is at high risk of acquiring TB infection, or has current or history of nontuberculous mycobacterium (NTMB) infection\n * Subject has any other condition, including medical or psychiatric, which, in the Investigator's judgment, would make the subject unsuitable for inclusion in the study\n * Subject has had previous exposure to adalimumab\n * Presence of active suicidal ideation or positive suicide behavior\n * Presence of moderately severe major depression or severe major depression\n * Subject has any active malignancy or history of malignancy within 5 years prior to the Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma, or in situ cervical cancer",{"$nulls":4},"Actual","2018-01-26","Actual","Anticipated","2020-03-01","Anticipated","2018-07-01","2018-01-22","2018-01-25","2018-07-19","Yes","Bimekizumab\nPSO\nPsoriasis","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"All",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2016-003392-22","EudraCT Number","Psoriasis Area and Severity Index 90 (PASI90) response at Week 16|Investigator's Global Assessment (IGA) response at Week 16","A PASI90 responder is defined as a subject that achieves 90% reduction from Baseline in the PASI score.|IGA response is defined as Clear or Almost Clear with at least a 2-category improvement relative to Baseline.","Week 16","PASI90 response at Week 24|IGA response at Week 24|PASI75 response at Week 4|PASI100 response at Week 16|PASI100 response at Week 24|PASI90 response at Week 56|IGA response at Week 56|Number of Treatment Emergent Adverse Events (TEAEs) adjusted by duration of subject exposure to study treatment|Number of Serious Adverse Events (SAEs) adjusted by duration of subject exposure to study treatment|Number of Treatment Emergent Adverse Events (TEAEs) leading to withdrawal adjusted by duration of subject exposure to study treatment","A PASI90 responder is defined as a subject that achieves 90% reduction from Baseline in the PASI score.|IGA response is defined as Clear or Almost Clear with at least 2-category improvement relative to Baseline.|A PASI75 responder is defined as a subject that achieves 75% reduction from Baseline in the PASI score.|A PASI100 responder is defined as a subject that achieves 100% reduction from Baseline in the PASI score.|The number of TEAEs adjusted by duration of exposure to study treatment is scaled such that it provides an incidence rate per 100 patient-years. If a subject has multiple events, the time of exposure is calculated to the first occurrence of the Adverse Event (AE) being considered. If a subject has no events, the total time at risk is used.|The number of adjusted SAEs by duration of exposure to study treatment is scaled such that it provides an incidence rate per 100 patient-years. If a subject has multiple events, the time of exposure is calculated to the first occurrence of the AE being considered. If a subject has no events, the total time at risk is used.|The number of TEAEs leading to discontinuation adjusted by duration of exposure to study treatment is scaled such that it provides an incidence rate per 100 patient-years. If a subject has multiple events, the time of exposure is calculated to the first occurrence of the AE being considered. If a subject has no events, the total time at risk is used.","Week 24|Week 4|Week 16|Week 56|From Baseline to Safety Follow Up (up to Week 76)","UCBCares@ucb.com","UCB Cares","+1844599 Ext. 2273","Calgary, Canada Ps0008 663Mississauga, Canada Ps0008 660MontrÃ©al, Canada Ps0008 661Peterborough, Canada Ps0008 662Toronto, Canada Ps0008 664Toronto, Canada Ps0008 657Waterloo, Canada Ps0008 667Waterloo, Canada Ps0008 669Windsor, Canada Ps0008 670Windsor, Canada Ps0008 674Winnipeg, Canada|Berlin, Germany Ps0008 203Dresden, Germany Ps0008 220Hamburg, Germany Ps0008 213Mahlow, Germany Ps0008 205OsnabrÃ¼ck, Germany Ps0008 217Schweinfurt, Germany|Budapest, Hungary Ps0008 254Budapest, Hungary Ps0008 255Budapest, Hungary Ps0008 256Debrecen, Hungary Ps0008 251Gyula, Hungary Ps0008 260Szeged, Hungary|BiaÅ‚ystok, Poland Ps0008 362BiaÅ‚ystok, Poland Ps0008 363KrakÃ³w, Poland Ps0008 353Szczecin, Poland Ps0008 365WrocÅ‚aw, Poland Ps0008 367WrocÅ‚aw, Poland Ps0008 360Å\u0081Ã³dÅº, Poland Ps0008 372Å\u0081Ã³dÅº, Poland Russian Federation Ps0008 401Saratov, Russian Federation|Glendale, Arizona, United States, 85308 Ps0008 957Glendale, Arizona, United States, 85308|San Diego, California, United States, 92123 Ps0008 943San Luis Obispo, California, United States, 93405 Ps0008 967Santa Monica, California, United States, 90404|Danbury, Connecticut, United States, 06810|Boca Raton, Florida, United States, 33486 Ps0008 936Tampa, Florida, United States, 33624|West Des Moines, Iowa, United States, 50265|Overland Park, Kansas, United States, 66215|Beverly, Massachusetts, United States, 01844 Ps0008 925Brighton, Massachusetts, United States, 02135|Troy, Michigan, United States, 48084|East Windsor, New Jersey, United States, 08520|Rocky Mount, North Carolina, United States, 27804|Oklahoma City, Oklahoma, United States, 73112|Portland, Oregon, United States, 97223|Greer, South Carolina, United States, 29650|Dallas, Texas, United States, 75231 Ps0008 924Houston, Texas, United States, 77004 Ps0008 951Houston, Texas, United States, 77004|Milwaukee, Wisconsin, United States, 53226","Arizona|California|Connecticut|Florida|Iowa|Kansas|Massachusetts|Michigan|New Jersey|North Carolina|Oklahoma|Oregon|South Carolina|Texas|Wisconsin","Canada|Germany|Hungary|Poland|United States","Ps0008 659|Ps0008 207|Ps0008 252|Ps0008 355|Ps0008 857|Ps0008 955|Ps0008 939|Ps0008 906|Ps0008 900|Ps0008 905|Ps0008 940|Ps0008 917|Ps0008 908|Ps0008 961|Ps0008 932|Ps0008 929|Ps0008 945|Ps0008 931|Ps0008 938",{"$nulls":3},"UCB Cares","2018-07-19","2020-05-25T16:38:56.081","2020-05-26T17:10:42.972","NCT03412747"]
["5ecbf4a011702c1b1b916b7a","NCT03412747","2018-08-20","UCB","UCBJF","Recruiting","A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis (BE SURE)","Bimekizumab|Adalimumab","IL17A Inhibitor|TNFa Inhibitor","Yes","['Bimekizumab', 'Adalimumab']","No",null,"Phase 3",3,450,"Anticipated","2018-01-26","2019-02-01","PASI","Psoriasis Area and Severity Index",{"$nulls":3},"This is a study to compare the efficacy of bimekizumab versus adalimumab in the treatment of subjects with moderate to severe chronic plaque psoriasis (PSO).",null,"A Phase 3, Multicenter, Randomized, Double-Blind Study With an Active-Controlled Initial Treatment Period Followed by a Dose-Blind Maintenance Treatment Period to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis","PS0008","Chronic Plaque Psoriasis\nModerate to Severe Plaque Psoriasis","Psoriasis","Dermatological Diseases","Derm & Connective Tissue Disorders","Experimental|Active Comparator","Bimekizumab Arm 1|Bimekizumab Arm 2|Adalimumab Arm","Subjects will receive bimekizumab dose regimen 1 for 56 weeks. Subjects will receive placebo at pre-specified time-points to maintain the blinding.|Subjects will receive bimekizumab dose regimen 1 for 16 weeks and will proceed with bimekizumab dose regimen 2 until week 56. Subjects will receive placebo at pre-specified time-points to maintain the blinding.|Subjects will receive adalimumab for 24 weeks and will then receive bimekizumab dose regimen 1 until week 56. Subjects will receive placebo at pre-specified time-points to maintain the blinding.","Drug","Bimekizumab|Adalimumab","Subjects will receive bimekizumab at pre-defined timepoints in dose regimen 1 and/or dose regimen 2.|Adalimumab will be administered according to the labeling recommendations.","UCB4940\nPlaceboSubjects will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products (IMP).|UCB4940|HumiraÂ®\nPlaceboSubjects will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products (IMP).","Bimekizumab Arm 1|Bimekizumab Arm 2|Adalimumab Arm","\n\n * Must be at least 18 years of age\n * Chronic plaque PSO for at least 6 months prior to the Screening Visit\n * Psoriasis Area Severity Index (PASI) >=12 and body surface area (BSA) affected by PSO >=10% and Investigator's Global Assessment (IGA) score >=3 on a 5-point scale\n * Subject is a candidate for systemic PSO therapy and/or phototherapy\n * Female subject of child bearing potential must be willing to use highly effective method of contraception\n\n","\n\n * Subject has a known hypersensitivity to any excipients of bimekizumab or adalimumab\n * Subject has an active infection (except common cold), a serious infection, or a history of opportunistic or recurrent chronic infections\n * Subject has concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection\n * Subject has known tuberculosis (TB) infection, is at high risk of acquiring TB infection, or has current or history of nontuberculous mycobacterium (NTMB) infection\n * Subject has any other condition, including medical or psychiatric, which, in the Investigator's judgment, would make the subject unsuitable for inclusion in the study\n * Subject has had previous exposure to adalimumab\n * Presence of active suicidal ideation or positive suicide behavior\n * Presence of moderately severe major depression or severe major depression\n * Subject has any active malignancy or history of malignancy within 5 years prior to the Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma, or in situ cervical cancer",{"$nulls":4},"Actual","2018-01-26","Actual","Anticipated","2020-03-01","Anticipated","2018-08-01","2018-01-22","2018-01-25","2018-08-17","Yes","Bimekizumab\nPSO\nPsoriasis","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"All",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2016-003392-22","EudraCT Number","Psoriasis Area and Severity Index 90 (PASI90) response at Week 16|Investigator's Global Assessment (IGA) response at Week 16","A PASI90 responder is defined as a subject that achieves 90% reduction from Baseline in the PASI score.|IGA response is defined as Clear or Almost Clear with at least a 2-category improvement relative to Baseline.","Week 16","PASI90 response at Week 24|IGA response at Week 24|PASI75 response at Week 4|PASI100 response at Week 16|PASI100 response at Week 24|PASI90 response at Week 56|IGA response at Week 56|Number of Treatment Emergent Adverse Events (TEAEs) adjusted by duration of subject exposure to study treatment|Number of Serious Adverse Events (SAEs) adjusted by duration of subject exposure to study treatment|Number of Treatment Emergent Adverse Events (TEAEs) leading to withdrawal adjusted by duration of subject exposure to study treatment","A PASI90 responder is defined as a subject that achieves 90% reduction from Baseline in the PASI score.|IGA response is defined as Clear or Almost Clear with at least 2-category improvement relative to Baseline.|A PASI75 responder is defined as a subject that achieves 75% reduction from Baseline in the PASI score.|A PASI100 responder is defined as a subject that achieves 100% reduction from Baseline in the PASI score.|The number of TEAEs adjusted by duration of exposure to study treatment is scaled such that it provides an incidence rate per 100 patient-years. If a subject has multiple events, the time of exposure is calculated to the first occurrence of the Adverse Event (AE) being considered. If a subject has no events, the total time at risk is used.|The number of adjusted SAEs by duration of exposure to study treatment is scaled such that it provides an incidence rate per 100 patient-years. If a subject has multiple events, the time of exposure is calculated to the first occurrence of the AE being considered. If a subject has no events, the total time at risk is used.|The number of TEAEs leading to discontinuation adjusted by duration of exposure to study treatment is scaled such that it provides an incidence rate per 100 patient-years. If a subject has multiple events, the time of exposure is calculated to the first occurrence of the AE being considered. If a subject has no events, the total time at risk is used.","Week 24|Week 4|Week 16|Week 56|From Baseline to Safety Follow Up (up to Week 76)","UCBCares@ucb.com","UCB Cares","+1844599 Ext. 2273","Woolloongabba, Australia|Calgary, Canada Ps0008 663Mississauga, Canada Ps0008 660MontrÃ©al, Canada Ps0008 661Peterborough, Canada Ps0008 662Toronto, Canada Ps0008 664Toronto, Canada Ps0008 657Waterloo, Canada Ps0008 669Windsor, Canada Ps0008 670Windsor, Canada Ps0008 674Winnipeg, Canada|Berlin, Germany Ps0008 218Bonn, Germany Ps0008 203Dresden, Germany Ps0008 211Hamburg, Germany Ps0008 220Hamburg, Germany Ps0008 213Mahlow, Germany Ps0008 205OsnabrÃ¼ck, Germany Ps0008 217Schweinfurt, Germany|Budapest, Hungary Ps0008 254Budapest, Hungary Ps0008 255Budapest, Hungary Ps0008 256Debrecen, Hungary Ps0008 251Gyula, Hungary Ps0008 260Szeged, Hungary Korea, Republic Of Ps0008 700Seoul, Korea, Republic Of Ps0008 704Seoul, Korea, Republic Of|BiaÅ‚ystok, Poland Ps0008 362BiaÅ‚ystok, Poland Ps0008 371Bydgoszcz, Poland Ps0008 352GdaÅ„sk, Poland Ps0008 359Katowice, Poland Ps0008 366Katowice, Poland Ps0008 363KrakÃ³w, Poland Ps0008 356Lublin, Poland Ps0008 364Nowa SÃ³l, Poland Ps0008 353Szczecin, Poland Ps0008 354Warszawa, Poland Ps0008 365WrocÅ‚aw, Poland Ps0008 367WrocÅ‚aw, Poland Ps0008 373WrocÅ‚aw, Poland Ps0008 360Å\u0081Ã³dÅº, Poland Ps0008 372Å\u0081Ã³dÅº, Poland Russian Federation Ps0008 405Saint Petersburg, Russian Federation Ps0008 401Saratov, Russian Federation Ps0008 406Yaroslavl, Russian Federation|Glendale, Arizona, United States, 85308|Los Angeles, California, United States, 90033 Ps0008 955San Diego, California, United States, 92123 Ps0008 943San Luis Obispo, California, United States, 93405 Ps0008 967Santa Monica, California, United States, 90404|Danbury, Connecticut, United States, 06810 United States, District Of Columbia Ps0008 934Washington, District Of Columbia, United States, 20037|Boca Raton, Florida, United States, 33486 Ps0008 936Tampa, Florida, United States, 33624|West Des Moines, Iowa, United States, 50265|Overland Park, Kansas, United States, 66215|Beverly, Massachusetts, United States, 01844 Ps0008 925Brighton, Massachusetts, United States, 02135|Troy, Michigan, United States, 48084|East Windsor, New Jersey, United States, 08520|Rocky Mount, North Carolina, United States, 27804|Oklahoma City, Oklahoma, United States, 73112|Portland, Oregon, United States, 97223|Greer, South Carolina, United States, 29650|Dallas, Texas, United States, 75231 Ps0008 924Houston, Texas, United States, 77004 Ps0008 951Houston, Texas, United States, 77004","Arizona|California|Connecticut|Florida|Iowa|Kansas|Massachusetts|Michigan|New Jersey|North Carolina|Oklahoma|Oregon|South Carolina|Texas","Australia|Canada|Germany|Hungary|Poland|United States","Ps0008 009|Ps0008 659|Ps0008 207|Ps0008 252|Ps0008 355|Ps0008 957|Ps0008 927|Ps0008 939|Ps0008 906|Ps0008 900|Ps0008 905|Ps0008 940|Ps0008 917|Ps0008 908|Ps0008 961|Ps0008 932|Ps0008 929|Ps0008 945|Ps0008 931",{"$nulls":3},"UCB Cares","2018-08-17","2020-05-25T16:38:56.364","2020-05-26T17:10:42.972","NCT03412747"]
["5ecbf4a0feab101b1553099c","NCT03412747","2018-08-31","UCB","UCBJF","Recruiting","A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis (BE SURE)","Bimekizumab|Adalimumab","IL17A Inhibitor|TNFa Inhibitor","Yes","['Bimekizumab', 'Adalimumab']","No",null,"Phase 3",3,450,"Anticipated","2018-01-26","2019-02-01","PASI","Psoriasis Area and Severity Index",{"$nulls":3},"This is a study to compare the efficacy of bimekizumab versus adalimumab in the treatment of subjects with moderate to severe chronic plaque psoriasis (PSO).",null,"A Phase 3, Multicenter, Randomized, Double-Blind Study With an Active-Controlled Initial Treatment Period Followed by a Dose-Blind Maintenance Treatment Period to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis","PS0008","Chronic Plaque Psoriasis\nModerate to Severe Plaque Psoriasis","Psoriasis","Dermatological Diseases","Derm & Connective Tissue Disorders","Experimental|Active Comparator","Bimekizumab Arm 1|Bimekizumab Arm 2|Adalimumab Arm","Subjects will receive bimekizumab dose regimen 1 for 56 weeks. Subjects will receive placebo at pre-specified time-points to maintain the blinding.|Subjects will receive bimekizumab dose regimen 1 for 16 weeks and will proceed with bimekizumab dose regimen 2 until week 56. Subjects will receive placebo at pre-specified time-points to maintain the blinding.|Subjects will receive adalimumab for 24 weeks and will then receive bimekizumab dose regimen 1 until week 56. Subjects will receive placebo at pre-specified time-points to maintain the blinding.","Drug","Bimekizumab|Adalimumab","Subjects will receive bimekizumab at pre-defined timepoints in dose regimen 1 and/or dose regimen 2.|Adalimumab will be administered according to the labeling recommendations.","UCB4940\nPlaceboSubjects will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products (IMP).|UCB4940|HumiraÂ®\nPlaceboSubjects will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products (IMP).","Bimekizumab Arm 1|Bimekizumab Arm 2|Adalimumab Arm","\n\n * Must be at least 18 years of age\n * Chronic plaque PSO for at least 6 months prior to the Screening Visit\n * Psoriasis Area Severity Index (PASI) >=12 and body surface area (BSA) affected by PSO >=10% and Investigator's Global Assessment (IGA) score >=3 on a 5-point scale\n * Subject is a candidate for systemic PSO therapy and/or phototherapy\n * Female subject of child bearing potential must be willing to use highly effective method of contraception\n\n","\n\n * Subject has a known hypersensitivity to any excipients of bimekizumab or adalimumab\n * Subject has an active infection (except common cold), a serious infection, or a history of opportunistic or recurrent chronic infections\n * Subject has concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection\n * Subject has known tuberculosis (TB) infection, is at high risk of acquiring TB infection, or has current or history of nontuberculous mycobacterium (NTMB) infection\n * Subject has any other condition, including medical or psychiatric, which, in the Investigator's judgment, would make the subject unsuitable for inclusion in the study\n * Subject has had previous exposure to adalimumab\n * Presence of active suicidal ideation or positive suicide behavior\n * Presence of moderately severe major depression or severe major depression\n * Subject has any active malignancy or history of malignancy within 5 years prior to the Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma, or in situ cervical cancer",{"$nulls":4},"Actual","2018-01-26","Actual","Anticipated","2020-03-01","Anticipated","2018-08-01","2018-01-22","2018-01-25","2018-08-30","Yes","Bimekizumab\nPSO\nPsoriasis","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"All",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2016-003392-22","EudraCT Number","Psoriasis Area and Severity Index 90 (PASI90) response at Week 16|Investigator's Global Assessment (IGA) response at Week 16","A PASI90 responder is defined as a subject that achieves 90% reduction from Baseline in the PASI score.|IGA response is defined as Clear or Almost Clear with at least a 2-category improvement relative to Baseline.","Week 16","PASI90 response at Week 24|IGA response at Week 24|PASI75 response at Week 4|PASI100 response at Week 16|PASI100 response at Week 24|PASI90 response at Week 56|IGA response at Week 56|Number of Treatment Emergent Adverse Events (TEAEs) adjusted by duration of subject exposure to study treatment|Number of Serious Adverse Events (SAEs) adjusted by duration of subject exposure to study treatment|Number of Treatment Emergent Adverse Events (TEAEs) leading to withdrawal adjusted by duration of subject exposure to study treatment","A PASI90 responder is defined as a subject that achieves 90% reduction from Baseline in the PASI score.|IGA response is defined as Clear or Almost Clear with at least 2-category improvement relative to Baseline.|A PASI75 responder is defined as a subject that achieves 75% reduction from Baseline in the PASI score.|A PASI100 responder is defined as a subject that achieves 100% reduction from Baseline in the PASI score.|The number of TEAEs adjusted by duration of exposure to study treatment is scaled such that it provides an incidence rate per 100 patient-years. If a subject has multiple events, the time of exposure is calculated to the first occurrence of the Adverse Event (AE) being considered. If a subject has no events, the total time at risk is used.|The number of adjusted SAEs by duration of exposure to study treatment is scaled such that it provides an incidence rate per 100 patient-years. If a subject has multiple events, the time of exposure is calculated to the first occurrence of the AE being considered. If a subject has no events, the total time at risk is used.|The number of TEAEs leading to discontinuation adjusted by duration of exposure to study treatment is scaled such that it provides an incidence rate per 100 patient-years. If a subject has multiple events, the time of exposure is calculated to the first occurrence of the AE being considered. If a subject has no events, the total time at risk is used.","Week 24|Week 4|Week 16|Week 56|From Baseline to Safety Follow Up (up to Week 76)","UCBCares@ucb.com","UCB Cares","+1844599 Ext. 2273","East Melbourne, Australia Ps0008 004Fremantle, Australia Ps0008 007Hectorville, Australia Ps0008 010Kogarah, Australia Ps0008 005Phillip, Australia Ps0008 009Woolloongabba, Australia|Calgary, Canada Ps0008 663Mississauga, Canada Ps0008 660MontrÃ©al, Canada Ps0008 661Peterborough, Canada Ps0008 662Toronto, Canada Ps0008 664Toronto, Canada Ps0008 657Waterloo, Canada Ps0008 669Windsor, Canada Ps0008 670Windsor, Canada Ps0008 674Winnipeg, Canada|Berlin, Germany Ps0008 218Bonn, Germany Ps0008 203Dresden, Germany Ps0008 211Hamburg, Germany Ps0008 220Hamburg, Germany Ps0008 215Lubeck, Germany Ps0008 213Mahlow, Germany Ps0008 205OsnabrÃ¼ck, Germany Ps0008 217Schweinfurt, Germany|Budapest, Hungary Ps0008 254Budapest, Hungary Ps0008 255Budapest, Hungary Ps0008 256Debrecen, Hungary Ps0008 251Gyula, Hungary Ps0008 260Szeged, Hungary Korea, Republic Of Ps0008 702Gwangju, Korea, Republic Of Ps0008 700Seoul, Korea, Republic Of Ps0008 704Seoul, Korea, Republic Of|BiaÅ‚ystok, Poland Ps0008 362BiaÅ‚ystok, Poland Ps0008 371Bydgoszcz, Poland Ps0008 352GdaÅ„sk, Poland Ps0008 359Katowice, Poland Ps0008 366Katowice, Poland Ps0008 363KrakÃ³w, Poland Ps0008 356Lublin, Poland Ps0008 364Nowa SÃ³l, Poland Ps0008 353Szczecin, Poland Ps0008 354Warszawa, Poland Ps0008 365WrocÅ‚aw, Poland Ps0008 367WrocÅ‚aw, Poland Ps0008 373WrocÅ‚aw, Poland Ps0008 360Å\u0081Ã³dÅº, Poland Ps0008 372Å\u0081Ã³dÅº, Poland Russian Federation Ps0008 405Saint Petersburg, Russian Federation Ps0008 401Saratov, Russian Federation Ps0008 406Yaroslavl, Russian Federation|Glendale, Arizona, United States, 85308|Los Angeles, California, United States, 90033 Ps0008 955San Diego, California, United States, 92123 Ps0008 943San Luis Obispo, California, United States, 93405 Ps0008 967Santa Monica, California, United States, 90404|Danbury, Connecticut, United States, 06810 United States, District Of Columbia Ps0008 934Washington, District Of Columbia, United States, 20037|Boca Raton, Florida, United States, 33486 Ps0008 936Tampa, Florida, United States, 33624|West Des Moines, Iowa, United States, 50265|Overland Park, Kansas, United States, 66215|Beverly, Massachusetts, United States, 01844 Ps0008 925Brighton, Massachusetts, United States, 02135|Troy, Michigan, United States, 48084|East Windsor, New Jersey, United States, 08520|Rocky Mount, North Carolina, United States, 27804|Oklahoma City, Oklahoma, United States, 73112|Portland, Oregon, United States, 97223|Greer, South Carolina, United States, 29650|Dallas, Texas, United States, 75231 Ps0008 924Houston, Texas, United States, 77004 Ps0008 951Houston, Texas, United States, 77004","Arizona|California|Connecticut|Florida|Iowa|Kansas|Massachusetts|Michigan|New Jersey|North Carolina|Oklahoma|Oregon|South Carolina|Texas","Australia|Canada|Germany|Hungary|Poland|United States","Ps0008 008|Ps0008 659|Ps0008 207|Ps0008 252|Ps0008 355|Ps0008 957|Ps0008 927|Ps0008 939|Ps0008 906|Ps0008 900|Ps0008 905|Ps0008 940|Ps0008 917|Ps0008 908|Ps0008 961|Ps0008 932|Ps0008 929|Ps0008 945|Ps0008 931",{"$nulls":3},"UCB Cares","2018-08-30","2020-05-25T16:38:56.146","2020-05-26T17:10:42.972","NCT03412747"]
["5ecbf4a0e2561b1b11905e68","NCT03412747","2018-10-01","UCB","UCBJF","Recruiting","A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis (BE SURE)","Bimekizumab|Adalimumab","IL17A Inhibitor|TNFa Inhibitor","Yes","['Bimekizumab', 'Adalimumab']","No",null,"Phase 3",3,450,"Anticipated","2018-01-26","2019-02-01","PASI","Psoriasis Area and Severity Index",{"$nulls":3},"This is a study to compare the efficacy of bimekizumab versus adalimumab in the treatment of subjects with moderate to severe chronic plaque psoriasis (PSO).",null,"A Phase 3, Multicenter, Randomized, Double-Blind Study With an Active-Controlled Initial Treatment Period Followed by a Dose-Blind Maintenance Treatment Period to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis","PS0008","Chronic Plaque Psoriasis\nModerate to Severe Plaque Psoriasis","Psoriasis","Dermatological Diseases","Derm & Connective Tissue Disorders","Experimental|Active Comparator","Bimekizumab Arm 1|Bimekizumab Arm 2|Adalimumab Arm","Subjects will receive bimekizumab dose regimen 1 for 56 weeks. Subjects will receive placebo at pre-specified time-points to maintain the blinding.|Subjects will receive bimekizumab dose regimen 1 for 16 weeks and will proceed with bimekizumab dose regimen 2 until week 56. Subjects will receive placebo at pre-specified time-points to maintain the blinding.|Subjects will receive adalimumab for 24 weeks and will then receive bimekizumab dose regimen 1 until week 56. Subjects will receive placebo at pre-specified time-points to maintain the blinding.","Drug","Bimekizumab|Adalimumab","Subjects will receive bimekizumab at pre-defined timepoints in dose regimen 1 and/or dose regimen 2.|Adalimumab will be administered according to the labeling recommendations.","UCB4940\nPlaceboSubjects will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products (IMP).|UCB4940|HumiraÂ®\nPlaceboSubjects will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products (IMP).","Bimekizumab Arm 1|Bimekizumab Arm 2|Adalimumab Arm","\n\n * Must be at least 18 years of age\n * Chronic plaque PSO for at least 6 months prior to the Screening Visit\n * Psoriasis Area Severity Index (PASI) >=12 and body surface area (BSA) affected by PSO >=10% and Investigator's Global Assessment (IGA) score >=3 on a 5-point scale\n * Subject is a candidate for systemic PSO therapy and/or phototherapy\n * Female subject of child bearing potential must be willing to use highly effective method of contraception\n\n","\n\n * Subject has a known hypersensitivity to any excipients of bimekizumab or adalimumab\n * Subject has an active infection (except common cold), a serious infection, or a history of opportunistic or recurrent chronic infections\n * Subject has concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection\n * Subject has known tuberculosis (TB) infection, is at high risk of acquiring TB infection, or has current or history of nontuberculous mycobacterium (NTMB) infection\n * Subject has any other condition, including medical or psychiatric, which, in the Investigator's judgment, would make the subject unsuitable for inclusion in the study\n * Subject has had previous exposure to adalimumab\n * Presence of active suicidal ideation or positive suicide behavior\n * Presence of moderately severe major depression or severe major depression\n * Subject has any active malignancy or history of malignancy within 5 years prior to the Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma, or in situ cervical cancer",{"$nulls":4},"Actual","2018-01-26","Actual","Anticipated","2020-03-01","Anticipated","2018-09-01","2018-01-22","2018-01-25","2018-09-28","Yes","Bimekizumab\nPSO\nPsoriasis","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"All",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2016-003392-22","EudraCT Number","Psoriasis Area and Severity Index 90 (PASI90) response at Week 16|Investigator's Global Assessment (IGA) response at Week 16","A PASI90 responder is defined as a subject that achieves 90% reduction from Baseline in the PASI score.|IGA response is defined as Clear or Almost Clear with at least a 2-category improvement relative to Baseline.","Week 16","PASI90 response at Week 24|IGA response at Week 24|PASI75 response at Week 4|PASI100 response at Week 16|PASI100 response at Week 24|PASI90 response at Week 56|IGA response at Week 56|Number of Treatment Emergent Adverse Events (TEAEs) adjusted by duration of subject exposure to study treatment|Number of Serious Adverse Events (SAEs) adjusted by duration of subject exposure to study treatment|Number of Treatment Emergent Adverse Events (TEAEs) leading to withdrawal adjusted by duration of subject exposure to study treatment","A PASI90 responder is defined as a subject that achieves 90% reduction from Baseline in the PASI score.|IGA response is defined as Clear or Almost Clear with at least 2-category improvement relative to Baseline.|A PASI75 responder is defined as a subject that achieves 75% reduction from Baseline in the PASI score.|A PASI100 responder is defined as a subject that achieves 100% reduction from Baseline in the PASI score.|The number of TEAEs adjusted by duration of exposure to study treatment is scaled such that it provides an incidence rate per 100 patient-years. If a subject has multiple events, the time of exposure is calculated to the first occurrence of the Adverse Event (AE) being considered. If a subject has no events, the total time at risk is used.|The number of adjusted SAEs by duration of exposure to study treatment is scaled such that it provides an incidence rate per 100 patient-years. If a subject has multiple events, the time of exposure is calculated to the first occurrence of the AE being considered. If a subject has no events, the total time at risk is used.|The number of TEAEs leading to discontinuation adjusted by duration of exposure to study treatment is scaled such that it provides an incidence rate per 100 patient-years. If a subject has multiple events, the time of exposure is calculated to the first occurrence of the AE being considered. If a subject has no events, the total time at risk is used.","Week 24|Week 4|Week 16|Week 56|From Baseline to Safety Follow Up (up to Week 76)","UCBCares@ucb.com","UCB Cares","+1844599 Ext. 2273","East Melbourne, Australia Ps0008 004Fremantle, Australia Ps0008 007Hectorville, Australia Ps0008 010Kogarah, Australia Ps0008 005Phillip, Australia Ps0008 009Woolloongabba, Australia|[Active, Not Recruiting]Calgary, Canada Ps0008 663[Active, Not Recruiting]Mississauga, Canada Ps0008 660[Active, Not Recruiting]MontrÃ©al, Canada Ps0008 661[Active, Not Recruiting]Peterborough, Canada Ps0008 662[Active, Not Recruiting]Toronto, Canada Ps0008 664[Active, Not Recruiting]Toronto, Canada Ps0008 657[Active, Not Recruiting]Waterloo, Canada Ps0008 669[Active, Not Recruiting]Windsor, Canada Ps0008 670[Active, Not Recruiting]Windsor, Canada Ps0008 674[Active, Not Recruiting]Winnipeg, Canada|Berlin, Germany Ps0008 218Bonn, Germany Ps0008 203Dresden, Germany Ps0008 211Hamburg, Germany Ps0008 220Hamburg, Germany Ps0008 215Lubeck, Germany Ps0008 213Mahlow, Germany Ps0008 205OsnabrÃ¼ck, Germany Ps0008 217Schweinfurt, Germany Ps0008 222Tuebingen, Germany|Budapest, Hungary Ps0008 254Budapest, Hungary Ps0008 255Budapest, Hungary Ps0008 256Debrecen, Hungary Ps0008 251Gyula, Hungary Ps0008 260Szeged, Hungary Korea, Republic Of Ps0008 702Gwangju, Korea, Republic Of Ps0008 700Seoul, Korea, Republic Of Ps0008 704Seoul, Korea, Republic Of|BiaÅ‚ystok, Poland Ps0008 362BiaÅ‚ystok, Poland Ps0008 371Bydgoszcz, Poland Ps0008 352GdaÅ„sk, Poland Ps0008 359Katowice, Poland Ps0008 366Katowice, Poland Ps0008 363KrakÃ³w, Poland Ps0008 356Lublin, Poland Ps0008 364Nowa SÃ³l, Poland Ps0008 353Szczecin, Poland Ps0008 354Warszawa, Poland Ps0008 365WrocÅ‚aw, Poland Ps0008 367WrocÅ‚aw, Poland Ps0008 373WrocÅ‚aw, Poland Ps0008 360Å\u0081Ã³dÅº, Poland Ps0008 372Å\u0081Ã³dÅº, Poland Russian Federation Ps0008 405Saint Petersburg, Russian Federation Ps0008 401Saratov, Russian Federation Ps0008 406Yaroslavl, Russian Federation|[Active, Not Recruiting]Glendale, Arizona, United States, 85308|[Active, Not Recruiting]Los Angeles, California, United States, 90033 Ps0008 955[Active, Not Recruiting]San Diego, California, United States, 92123 Ps0008 943[Active, Not Recruiting]San Luis Obispo, California, United States, 93405 Ps0008 967[Active, Not Recruiting]Santa Monica, California, United States, 90404|[Active, Not Recruiting]Danbury, Connecticut, United States, 06810 United States, District Of Columbia Ps0008 934Washington, District Of Columbia, United States, 20037|[Active, Not Recruiting]Boca Raton, Florida, United States, 33486 Ps0008 936[Active, Not Recruiting]Tampa, Florida, United States, 33624|[Active, Not Recruiting]West Des Moines, Iowa, United States, 50265|[Active, Not Recruiting]Overland Park, Kansas, United States, 66215|[Active, Not Recruiting]Beverly, Massachusetts, United States, 01844 Ps0008 925[Active, Not Recruiting]Brighton, Massachusetts, United States, 02135|[Active, Not Recruiting]Troy, Michigan, United States, 48084|[Active, Not Recruiting]East Windsor, New Jersey, United States, 08520|[Active, Not Recruiting]Rocky Mount, North Carolina, United States, 27804 Ps0008 935[Active, Not Recruiting]Winston-Salem, North Carolina, United States, 27104-35 20|[Active, Not Recruiting]Oklahoma City, Oklahoma, United States, 73112|[Active, Not Recruiting]Portland, Oregon, United States, 97223|[Active, Not Recruiting]Greer, South Carolina, United States, 29650|[Active, Not Recruiting]Dallas, Texas, United States, 75231 Ps0008 924[Active, Not Recruiting]Houston, Texas, United States, 77004 Ps0008 951[Active, Not Recruiting]Houston, Texas, United States, 77004","Arizona|California|Connecticut|Florida|Iowa|Kansas|Massachusetts|Michigan|New Jersey|North Carolina|Oklahoma|Oregon|South Carolina|Texas","Australia|Canada|Germany|Hungary|Poland|United States","Ps0008 008|Ps0008 659|Ps0008 207|Ps0008 252|Ps0008 355|Ps0008 957|Ps0008 927|Ps0008 939|Ps0008 906|Ps0008 900|Ps0008 905|Ps0008 940|Ps0008 917|Ps0008 908|Ps0008 961|Ps0008 932|Ps0008 929|Ps0008 945|Ps0008 931",{"$nulls":3},"UCB Cares","2018-09-28","2020-05-25T16:38:56.879","2020-05-26T17:10:42.972","NCT03412747"]
["5ecbf4a011702c1b1b916b7b","NCT03412747","2019-03-20","UCB","UCBJF","Active, not recruiting","A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis (BE SURE)","Bimekizumab|Adalimumab","IL17A Inhibitor|TNFa Inhibitor","Yes","['Bimekizumab', 'Adalimumab']","No",null,"Phase 3",3,480,"Actual","2018-01-26","2019-02-07","PASI","Psoriasis Area and Severity Index",{"$nulls":3},"This is a study to compare the efficacy of bimekizumab versus adalimumab in the treatment of subjects with moderate to severe chronic plaque psoriasis (PSO).",null,"A Phase 3, Multicenter, Randomized, Double-Blind Study With an Active-Controlled Initial Treatment Period Followed by a Dose-Blind Maintenance Treatment Period to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis","PS0008","Chronic Plaque Psoriasis\nModerate to Severe Plaque Psoriasis","Psoriasis","Dermatological Diseases","Derm & Connective Tissue Disorders","Experimental|Active Comparator","Bimekizumab Arm 1|Bimekizumab Arm 2|Adalimumab Arm","Subjects will receive bimekizumab dose regimen 1 for 56 weeks. Subjects will receive placebo at pre-specified time-points to maintain the blinding.|Subjects will receive bimekizumab dose regimen 1 for 16 weeks and will proceed with bimekizumab dose regimen 2 until week 56. Subjects will receive placebo at pre-specified time-points to maintain the blinding.|Subjects will receive adalimumab for 24 weeks and will then receive bimekizumab dose regimen 1 until week 56. Subjects will receive placebo at pre-specified time-points to maintain the blinding.","Drug","Bimekizumab|Adalimumab","Subjects will receive bimekizumab at pre-defined timepoints in dose regimen 1 and/or dose regimen 2.|Adalimumab will be administered according to the labeling recommendations.","UCB4940\nPlaceboSubjects will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products (IMP).|UCB4940|HumiraÂ®\nPlaceboSubjects will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products (IMP).","Bimekizumab Arm 1|Bimekizumab Arm 2|Adalimumab Arm","\n\n * Must be at least 18 years of age\n * Chronic plaque PSO for at least 6 months prior to the Screening Visit\n * Psoriasis Area Severity Index (PASI) >=12 and body surface area (BSA) affected by PSO >=10% and Investigator's Global Assessment (IGA) score >=3 on a 5-point scale\n * Subject is a candidate for systemic PSO therapy and/or phototherapy\n * Female subject of child bearing potential must be willing to use highly effective method of contraception\n\n","\n\n * Subject has a known hypersensitivity to any excipients of bimekizumab or adalimumab\n * Subject has an active infection (except common cold), a serious infection, or a history of opportunistic or recurrent chronic infections\n * Subject has concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection\n * Subject has known tuberculosis (TB) infection, is at high risk of acquiring TB infection, or has current or history of nontuberculous mycobacterium (NTMB) infection\n * Subject has any other condition, including medical or psychiatric, which, in the Investigator's judgment, would make the subject unsuitable for inclusion in the study\n * Subject has had previous exposure to adalimumab\n * Presence of active suicidal ideation or positive suicide behavior\n * Presence of moderately severe major depression or severe major depression\n * Subject has any active malignancy or history of malignancy within 5 years prior to the Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma, or in situ cervical cancer",{"$nulls":4},"Actual","2018-01-26","Actual","Actual","2020-03-01","Anticipated","2019-03-01","2018-01-22","2018-01-25","2019-03-18","Yes","Bimekizumab\nPSO\nPsoriasis","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"All",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2016-003392-22","EudraCT Number","Psoriasis Area and Severity Index 90 (PASI90) response at Week 16|Investigator's Global Assessment (IGA) response at Week 16","A PASI90 responder is defined as a subject that achieves 90% reduction from Baseline in the PASI score.|IGA response is defined as Clear or Almost Clear with at least a 2-category improvement relative to Baseline.","Week 16","PASI90 response at Week 24|IGA response at Week 24|PASI75 response at Week 4|PASI100 response at Week 16|PASI100 response at Week 24|PASI90 response at Week 56|IGA response at Week 56|Number of Treatment Emergent Adverse Events (TEAEs) adjusted by duration of subject exposure to study treatment|Number of Serious Adverse Events (SAEs) adjusted by duration of subject exposure to study treatment|Number of Treatment Emergent Adverse Events (TEAEs) leading to withdrawal adjusted by duration of subject exposure to study treatment","A PASI90 responder is defined as a subject that achieves 90% reduction from Baseline in the PASI score.|IGA response is defined as Clear or Almost Clear with at least 2-category improvement relative to Baseline.|A PASI75 responder is defined as a subject that achieves 75% reduction from Baseline in the PASI score.|A PASI100 responder is defined as a subject that achieves 100% reduction from Baseline in the PASI score.|The number of TEAEs adjusted by duration of exposure to study treatment is scaled such that it provides an incidence rate per 100 patient-years. If a subject has multiple events, the time of exposure is calculated to the first occurrence of the Adverse Event (AE) being considered. If a subject has no events, the total time at risk is used.|The number of adjusted SAEs by duration of exposure to study treatment is scaled such that it provides an incidence rate per 100 patient-years. If a subject has multiple events, the time of exposure is calculated to the first occurrence of the AE being considered. If a subject has no events, the total time at risk is used.|The number of TEAEs leading to discontinuation adjusted by duration of exposure to study treatment is scaled such that it provides an incidence rate per 100 patient-years. If a subject has multiple events, the time of exposure is calculated to the first occurrence of the AE being considered. If a subject has no events, the total time at risk is used.","Week 24|Week 4|Week 16|Week 56|From Baseline to Safety Follow Up (up to Week 76)",{"$nulls":3},"East Melbourne, Australia Ps0008 004Fremantle, Australia Ps0008 007Hectorville, Australia Ps0008 010Kogarah, Australia Ps0008 005Phillip, Australia Ps0008 009Woolloongabba, Australia|Calgary, Canada Ps0008 663Mississauga, Canada Ps0008 660MontrÃ©al, Canada Ps0008 661Peterborough, Canada Ps0008 662Toronto, Canada Ps0008 664Toronto, Canada Ps0008 657Waterloo, Canada Ps0008 669Windsor, Canada Ps0008 670Windsor, Canada Ps0008 674Winnipeg, Canada|Berlin, Germany Ps0008 218Bonn, Germany Ps0008 203Dresden, Germany Ps0008 211Hamburg, Germany Ps0008 220Hamburg, Germany Ps0008 215Lubeck, Germany Ps0008 213Mahlow, Germany Ps0008 205OsnabrÃ¼ck, Germany Ps0008 217Schweinfurt, Germany|Budapest, Hungary Ps0008 254Budapest, Hungary Ps0008 255Budapest, Hungary Ps0008 256Debrecen, Hungary Ps0008 251Gyula, Hungary Ps0008 260Szeged, Hungary Korea, Republic Of Ps0008 702Gwangju, Korea, Republic Of Ps0008 700Seoul, Korea, Republic Of|BiaÅ‚ystok, Poland Ps0008 362BiaÅ‚ystok, Poland Ps0008 371Bydgoszcz, Poland Ps0008 352GdaÅ„sk, Poland Ps0008 359Katowice, Poland Ps0008 366Katowice, Poland Ps0008 363KrakÃ³w, Poland Ps0008 356Lublin, Poland Ps0008 364Nowa SÃ³l, Poland Ps0008 353Szczecin, Poland Ps0008 354Warszawa, Poland Ps0008 365WrocÅ‚aw, Poland Ps0008 367WrocÅ‚aw, Poland Ps0008 373WrocÅ‚aw, Poland Ps0008 360Å\u0081Ã³dÅº, Poland Ps0008 372Å\u0081Ã³dÅº, Poland Russian Federation Ps0008 405Saint Petersburg, Russian Federation Ps0008 401Saratov, Russian Federation Ps0008 406Yaroslavl, Russian Federation Taiwan Ps0008 754Taipei, Taiwan Ps0008 755Taipei, Taiwan|Glendale, Arizona, United States, 85308|Los Angeles, California, United States, 90033 Ps0008 955San Diego, California, United States, 92123 Ps0008 943San Luis Obispo, California, United States, 93405 Ps0008 967Santa Monica, California, United States, 90404|Danbury, Connecticut, United States, 06810 United States, District Of Columbia Ps0008 934Washington, District Of Columbia, United States, 20037|Boca Raton, Florida, United States, 33486 Ps0008 936Tampa, Florida, United States, 33624|West Des Moines, Iowa, United States, 50265|Overland Park, Kansas, United States, 66215|Beverly, Massachusetts, United States, 01844 Ps0008 925Brighton, Massachusetts, United States, 02135|Troy, Michigan, United States, 48084|East Windsor, New Jersey, United States, 08520|Rocky Mount, North Carolina, United States, 27804 Ps0008 935Winston-Salem, North Carolina, United States, 27104-35 20|Oklahoma City, Oklahoma, United States, 73112|Portland, Oregon, United States, 97223|Greer, South Carolina, United States, 29650|Dallas, Texas, United States, 75231 Ps0008 924Houston, Texas, United States, 77004 Ps0008 951Houston, Texas, United States, 77004","Arizona|California|Connecticut|Florida|Iowa|Kansas|Massachusetts|Michigan|New Jersey|North Carolina|Oklahoma|Oregon|South Carolina|Texas","Australia|Canada|Germany|Hungary|Poland|United States","Ps0008 008|Ps0008 659|Ps0008 207|Ps0008 252|Ps0008 355|Ps0008 957|Ps0008 927|Ps0008 939|Ps0008 906|Ps0008 900|Ps0008 905|Ps0008 940|Ps0008 917|Ps0008 908|Ps0008 961|Ps0008 932|Ps0008 929|Ps0008 945|Ps0008 931",{"$nulls":3},"UCB Cares","2019-03-18","2020-05-25T16:38:56.732","2020-05-26T17:10:42.972","NCT03412747"]
["5ecbf4a1307e3d1b1f8d9e00","NCT03412747","2019-09-20","UCB","UCBJF","Active, not recruiting","A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis (BE SURE)","Bimekizumab|Adalimumab","IL17A Inhibitor|TNFa Inhibitor","Yes","['Bimekizumab', 'Adalimumab']","No",null,"Phase 3",3,480,"Actual","2018-01-26","2019-02-07","PASI","Psoriasis Area and Severity Index",{"$nulls":3},"This is a study to compare the efficacy of bimekizumab versus adalimumab in the treatment of subjects with moderate to severe chronic plaque psoriasis (PSO).",null,"A Phase 3, Multicenter, Randomized, Double-Blind Study With an Active-Controlled Initial Treatment Period Followed by a Dose-Blind Maintenance Treatment Period to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis","PS0008","Chronic Plaque Psoriasis\nModerate to Severe Plaque Psoriasis","Psoriasis","Dermatological Diseases","Derm & Connective Tissue Disorders","Experimental|Active Comparator","Bimekizumab Arm 1|Bimekizumab Arm 2|Adalimumab Arm","Subjects will receive bimekizumab dose regimen 1 for 56 weeks. Subjects will receive placebo at pre-specified time-points to maintain the blinding.|Subjects will receive bimekizumab dose regimen 1 for 16 weeks and will proceed with bimekizumab dose regimen 2 until week 56. Subjects will receive placebo at pre-specified time-points to maintain the blinding.|Subjects will receive adalimumab for 24 weeks and will then receive bimekizumab dose regimen 1 until week 56. Subjects will receive placebo at pre-specified time-points to maintain the blinding.","Drug","Bimekizumab|Adalimumab","Subjects will receive bimekizumab at pre-defined timepoints in dose regimen 1 and/or dose regimen 2.|Adalimumab will be administered according to the labeling recommendations.","UCB4940\nPlaceboSubjects will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products (IMP).|UCB4940|HumiraÂ®\nPlaceboSubjects will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products (IMP).","Bimekizumab Arm 1|Bimekizumab Arm 2|Adalimumab Arm","\n\n * Must be at least 18 years of age\n * Chronic plaque PSO for at least 6 months prior to the Screening Visit\n * Psoriasis Area Severity Index (PASI) >=12 and body surface area (BSA) affected by PSO >=10% and Investigator's Global Assessment (IGA) score >=3 on a 5-point scale\n * Subject is a candidate for systemic PSO therapy and/or phototherapy\n * Female subject of child bearing potential must be willing to use highly effective method of contraception\n\n","\n\n * Subject has a known hypersensitivity to any excipients of bimekizumab or adalimumab\n * Subject has an active infection (except common cold), a serious infection, or a history of opportunistic or recurrent chronic infections\n * Subject has concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection\n * Subject has known tuberculosis (TB) infection, is at high risk of acquiring TB infection, or has current or history of nontuberculous mycobacterium (NTMB) infection\n * Subject has any other condition, including medical or psychiatric, which, in the Investigator's judgment, would make the subject unsuitable for inclusion in the study\n * Subject has had previous exposure to adalimumab\n * Presence of active suicidal ideation or positive suicide behavior\n * Presence of moderately severe major depression or severe major depression\n * Subject has any active malignancy or history of malignancy within 5 years prior to the Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma, or in situ cervical cancer",{"$nulls":4},"Actual","2018-01-26","Actual","Actual","2020-03-01","Anticipated","2019-09-01","2018-01-22","2018-01-25","2019-09-19","Yes","Bimekizumab\nPSO\nPsoriasis","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"All",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2016-003392-22","EudraCT Number","Psoriasis Area and Severity Index 90 (PASI90) response at Week 16|Investigator's Global Assessment (IGA) response at Week 16","A PASI90 responder is defined as a subject that achieves 90% reduction from Baseline in the PASI score.|IGA response is defined as Clear or Almost Clear with at least a 2-category improvement relative to Baseline.","Week 16","PASI90 response at Week 24|IGA response at Week 24|PASI75 response at Week 4|PASI100 response at Week 16|PASI100 response at Week 24|PASI90 response at Week 56|IGA response at Week 56|Number of Treatment Emergent Adverse Events (TEAEs) adjusted by duration of subject exposure to study treatment|Number of Serious Adverse Events (SAEs) adjusted by duration of subject exposure to study treatment|Number of Treatment Emergent Adverse Events (TEAEs) leading to withdrawal adjusted by duration of subject exposure to study treatment","A PASI90 responder is defined as a subject that achieves 90% reduction from Baseline in the PASI score.|IGA response is defined as Clear or Almost Clear with at least 2-category improvement relative to Baseline.|A PASI75 responder is defined as a subject that achieves 75% reduction from Baseline in the PASI score.|A PASI100 responder is defined as a subject that achieves 100% reduction from Baseline in the PASI score.|The number of TEAEs adjusted by duration of exposure to study treatment is scaled such that it provides an incidence rate per 100 patient-years. If a subject has multiple events, the time of exposure is calculated to the first occurrence of the Adverse Event (AE) being considered. If a subject has no events, the total time at risk is used.|The number of adjusted SAEs by duration of exposure to study treatment is scaled such that it provides an incidence rate per 100 patient-years. If a subject has multiple events, the time of exposure is calculated to the first occurrence of the AE being considered. If a subject has no events, the total time at risk is used.|The number of TEAEs leading to discontinuation adjusted by duration of exposure to study treatment is scaled such that it provides an incidence rate per 100 patient-years. If a subject has multiple events, the time of exposure is calculated to the first occurrence of the AE being considered. If a subject has no events, the total time at risk is used.","Week 24|Week 4|Week 16|Week 56|From Baseline to Safety Follow Up (up to Week 76)",{"$nulls":3},"East Melbourne, Australia Ps0008 004Fremantle, Australia Ps0008 007Hectorville, Australia Ps0008 010Kogarah, Australia Ps0008 005Phillip, Australia Ps0008 009Woolloongabba, Australia|Calgary, Canada Ps0008 663Mississauga, Canada Ps0008 660MontrÃ©al, Canada Ps0008 661Peterborough, Canada Ps0008 662Toronto, Canada Ps0008 664Toronto, Canada Ps0008 657Waterloo, Canada Ps0008 669Windsor, Canada Ps0008 670Windsor, Canada Ps0008 674Winnipeg, Canada|Berlin, Germany Ps0008 218Bonn, Germany Ps0008 203Dresden, Germany Ps0008 211Hamburg, Germany Ps0008 220Hamburg, Germany Ps0008 215Lubeck, Germany Ps0008 213Mahlow, Germany Ps0008 205OsnabrÃ¼ck, Germany Ps0008 217Schweinfurt, Germany|Budapest, Hungary Ps0008 254Budapest, Hungary Ps0008 255Budapest, Hungary Ps0008 256Debrecen, Hungary Ps0008 251Gyula, Hungary Ps0008 260Szeged, Hungary Korea, Republic Of Ps0008 702Gwangju, Korea, Republic Of Ps0008 700Seoul, Korea, Republic Of|BiaÅ‚ystok, Poland Ps0008 362BiaÅ‚ystok, Poland Ps0008 371Bydgoszcz, Poland Ps0008 352GdaÅ„sk, Poland Ps0008 359Katowice, Poland Ps0008 366Katowice, Poland Ps0008 363KrakÃ³w, Poland Ps0008 356Lublin, Poland Ps0008 364Nowa SÃ³l, Poland Ps0008 353Szczecin, Poland Ps0008 354Warszawa, Poland Ps0008 365WrocÅ‚aw, Poland Ps0008 367WrocÅ‚aw, Poland Ps0008 373WrocÅ‚aw, Poland Ps0008 360Å\u0081Ã³dÅº, Poland Ps0008 372Å\u0081Ã³dÅº, Poland Russian Federation Ps0008 405Saint Petersburg, Russian Federation Ps0008 401Saratov, Russian Federation Ps0008 406Yaroslavl, Russian Federation Taiwan Ps0008 754Taipei, Taiwan Ps0008 755Taipei, Taiwan|Glendale, Arizona, United States, 85308|Los Angeles, California, United States, 90033 Ps0008 955San Diego, California, United States, 92123 Ps0008 943San Luis Obispo, California, United States, 93405 Ps0008 967Santa Monica, California, United States, 90404|Danbury, Connecticut, United States, 06810 United States, District Of Columbia Ps0008 934Washington, District Of Columbia, United States, 20037|Boca Raton, Florida, United States, 33486 Ps0008 936Tampa, Florida, United States, 33624|West Des Moines, Iowa, United States, 50265|Overland Park, Kansas, United States, 66215|Beverly, Massachusetts, United States, 01844 Ps0008 925Brighton, Massachusetts, United States, 02135|Troy, Michigan, United States, 48084|East Windsor, New Jersey, United States, 08520|Rocky Mount, North Carolina, United States, 27804 Ps0008 935Winston-Salem, North Carolina, United States, 27104-35 20|Oklahoma City, Oklahoma, United States, 73112|Portland, Oregon, United States, 97223|Greer, South Carolina, United States, 29650|Dallas, Texas, United States, 75231 Ps0008 924Houston, Texas, United States, 77004 Ps0008 951Houston, Texas, United States, 77004","Arizona|California|Connecticut|Florida|Iowa|Kansas|Massachusetts|Michigan|New Jersey|North Carolina|Oklahoma|Oregon|South Carolina|Texas","Australia|Canada|Germany|Hungary|Poland|United States","Ps0008 008|Ps0008 659|Ps0008 207|Ps0008 252|Ps0008 355|Ps0008 957|Ps0008 927|Ps0008 939|Ps0008 906|Ps0008 900|Ps0008 905|Ps0008 940|Ps0008 917|Ps0008 908|Ps0008 961|Ps0008 932|Ps0008 929|Ps0008 945|Ps0008 931",{"$nulls":3},"UCB Cares","2019-09-19","2020-05-25T16:38:57.130","2020-05-26T17:10:42.972","NCT03412747"]
["5ecbf4a1feab101b1553099e","NCT03412747","2019-11-08","UCB","UCBJF","Active, not recruiting","A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis (BE SURE)","Bimekizumab|Adalimumab","IL17A Inhibitor|TNFa Inhibitor","Yes","['Bimekizumab', 'Adalimumab']","No",null,"Phase 3",3,480,"Actual","2018-01-26","2019-02-07","PASI","Psoriasis Area and Severity Index",{"$nulls":3},"This is a study to compare the efficacy of bimekizumab versus adalimumab in the treatment of subjects with moderate to severe chronic plaque psoriasis (PSO).",null,"A Phase 3, Multicenter, Randomized, Double-Blind Study With an Active-Controlled Initial Treatment Period Followed by a Dose-Blind Maintenance Treatment Period to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis","PS0008","Chronic Plaque Psoriasis\nModerate to Severe Plaque Psoriasis","Psoriasis","Dermatological Diseases","Derm & Connective Tissue Disorders","Experimental|Active Comparator","Bimekizumab Arm 1|Bimekizumab Arm 2|Adalimumab Arm","Subjects will receive bimekizumab dose regimen 1 for 56 weeks. Subjects will receive placebo at pre-specified time-points to maintain the blinding.|Subjects will receive bimekizumab dose regimen 1 for 16 weeks and will proceed with bimekizumab dose regimen 2 until week 56. Subjects will receive placebo at pre-specified time-points to maintain the blinding.|Subjects will receive adalimumab for 24 weeks and will then receive bimekizumab dose regimen 1 until week 56. Subjects will receive placebo at pre-specified time-points to maintain the blinding.","Drug","Bimekizumab|Adalimumab","Subjects will receive bimekizumab at pre-defined timepoints in dose regimen 1 and/or dose regimen 2.|Adalimumab will be administered according to the labeling recommendations.","UCB4940\nPlaceboSubjects will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products (IMP).|UCB4940|HumiraÂ®\nPlaceboSubjects will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products (IMP).","Bimekizumab Arm 1|Bimekizumab Arm 2|Adalimumab Arm","\n\n * Must be at least 18 years of age\n * Chronic plaque PSO for at least 6 months prior to the Screening Visit\n * Psoriasis Area Severity Index (PASI) >=12 and body surface area (BSA) affected by PSO >=10% and Investigator's Global Assessment (IGA) score >=3 on a 5-point scale\n * Subject is a candidate for systemic PSO therapy and/or phototherapy\n * Female subject of child bearing potential must be willing to use highly effective method of contraception\n\n","\n\n * Subject has a known hypersensitivity to any excipients of bimekizumab or adalimumab\n * Subject has an active infection (except common cold), a serious infection, or a history of opportunistic or recurrent chronic infections\n * Subject has concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection\n * Subject has known tuberculosis (TB) infection, is at high risk of acquiring TB infection, or has current or history of nontuberculous mycobacterium (NTMB) infection\n * Subject has any other condition, including medical or psychiatric, which, in the Investigator's judgment, would make the subject unsuitable for inclusion in the study\n * Subject has had previous exposure to adalimumab\n * Presence of active suicidal ideation or positive suicide behavior\n * Presence of moderately severe major depression or severe major depression\n * Subject has any active malignancy or history of malignancy within 5 years prior to the Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma, or in situ cervical cancer",{"$nulls":4},"Actual","2018-01-26","Actual","Actual","2020-03-01","Anticipated","2019-11-01","2018-01-22","2018-01-25","2019-11-07","Yes","Bimekizumab\nPSO\nPsoriasis","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"All",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2016-003392-22","EudraCT Number","Psoriasis Area and Severity Index 90 (PASI90) response at Week 16|Investigator's Global Assessment (IGA) response at Week 16","A PASI90 responder is defined as a subject that achieves 90% reduction from Baseline in the PASI score.|IGA response is defined as Clear or Almost Clear with at least a 2-category improvement relative to Baseline.","Week 16","PASI90 response at Week 24|IGA response at Week 24|PASI75 response at Week 4|PASI100 response at Week 16|PASI100 response at Week 24|PASI90 response at Week 56|IGA response at Week 56|Number of Treatment Emergent Adverse Events (TEAEs) adjusted by duration of subject exposure to study treatment|Number of Serious Adverse Events (SAEs) adjusted by duration of subject exposure to study treatment|Number of Treatment Emergent Adverse Events (TEAEs) leading to withdrawal adjusted by duration of subject exposure to study treatment","A PASI90 responder is defined as a subject that achieves 90% reduction from Baseline in the PASI score.|IGA response is defined as Clear or Almost Clear with at least 2-category improvement relative to Baseline.|A PASI75 responder is defined as a subject that achieves 75% reduction from Baseline in the PASI score.|A PASI100 responder is defined as a subject that achieves 100% reduction from Baseline in the PASI score.|The number of TEAEs adjusted by duration of exposure to study treatment is scaled such that it provides an incidence rate per 100 patient-years. If a subject has multiple events, the time of exposure is calculated to the first occurrence of the Adverse Event (AE) being considered. If a subject has no events, the total time at risk is used.|The number of adjusted SAEs by duration of exposure to study treatment is scaled such that it provides an incidence rate per 100 patient-years. If a subject has multiple events, the time of exposure is calculated to the first occurrence of the AE being considered. If a subject has no events, the total time at risk is used.|The number of TEAEs leading to discontinuation adjusted by duration of exposure to study treatment is scaled such that it provides an incidence rate per 100 patient-years. If a subject has multiple events, the time of exposure is calculated to the first occurrence of the AE being considered. If a subject has no events, the total time at risk is used.","Week 24|Week 4|Week 16|Week 56|From Baseline to Safety Follow Up (up to Week 76)",{"$nulls":3},"East Melbourne, Australia Ps0008 004Fremantle, Australia Ps0008 007Hectorville, Australia Ps0008 010Kogarah, Australia Ps0008 005Phillip, Australia Ps0008 009Woolloongabba, Australia|Calgary, Canada Ps0008 663Mississauga, Canada Ps0008 660MontrÃ©al, Canada Ps0008 661Peterborough, Canada Ps0008 662Toronto, Canada Ps0008 664Toronto, Canada Ps0008 657Waterloo, Canada Ps0008 669Windsor, Canada Ps0008 670Windsor, Canada Ps0008 674Winnipeg, Canada|Berlin, Germany Ps0008 218Bonn, Germany Ps0008 203Dresden, Germany Ps0008 211Hamburg, Germany Ps0008 220Hamburg, Germany Ps0008 215Lubeck, Germany Ps0008 213Mahlow, Germany Ps0008 205OsnabrÃ¼ck, Germany Ps0008 217Schweinfurt, Germany|Budapest, Hungary Ps0008 254Budapest, Hungary Ps0008 255Budapest, Hungary Ps0008 256Debrecen, Hungary Ps0008 251Gyula, Hungary Ps0008 260Szeged, Hungary Korea, Republic Of Ps0008 702Gwangju, Korea, Republic Of Ps0008 700Seoul, Korea, Republic Of|BiaÅ‚ystok, Poland Ps0008 362BiaÅ‚ystok, Poland Ps0008 371Bydgoszcz, Poland Ps0008 352GdaÅ„sk, Poland Ps0008 359Katowice, Poland Ps0008 366Katowice, Poland Ps0008 363KrakÃ³w, Poland Ps0008 356Lublin, Poland Ps0008 364Nowa SÃ³l, Poland Ps0008 353Szczecin, Poland Ps0008 354Warszawa, Poland Ps0008 365WrocÅ‚aw, Poland Ps0008 367WrocÅ‚aw, Poland Ps0008 373WrocÅ‚aw, Poland Ps0008 360Å\u0081Ã³dÅº, Poland Ps0008 372Å\u0081Ã³dÅº, Poland Russian Federation Ps0008 405Saint Petersburg, Russian Federation Ps0008 401Saratov, Russian Federation Ps0008 406Yaroslavl, Russian Federation Taiwan Ps0008 754Taipei, Taiwan Ps0008 755Taipei, Taiwan|Glendale, Arizona, United States, 85308|Los Angeles, California, United States, 90033 Ps0008 955San Diego, California, United States, 92123 Ps0008 943San Luis Obispo, California, United States, 93405 Ps0008 967Santa Monica, California, United States, 90404|Danbury, Connecticut, United States, 06810 United States, District Of Columbia Ps0008 934Washington, District Of Columbia, United States, 20037|Boca Raton, Florida, United States, 33486 Ps0008 936Tampa, Florida, United States, 33624|West Des Moines, Iowa, United States, 50265|Overland Park, Kansas, United States, 66215|Beverly, Massachusetts, United States, 01844 Ps0008 925Brighton, Massachusetts, United States, 02135|Troy, Michigan, United States, 48084|East Windsor, New Jersey, United States, 08520|Rocky Mount, North Carolina, United States, 27804 Ps0008 935Winston-Salem, North Carolina, United States, 27104-35 20|Oklahoma City, Oklahoma, United States, 73112|Portland, Oregon, United States, 97223|Greer, South Carolina, United States, 29650|Dallas, Texas, United States, 75231 Ps0008 924Houston, Texas, United States, 77004 Ps0008 951Houston, Texas, United States, 77004","Arizona|California|Connecticut|Florida|Iowa|Kansas|Massachusetts|Michigan|New Jersey|North Carolina|Oklahoma|Oregon|South Carolina|Texas","Australia|Canada|Germany|Hungary|Poland|United States","Ps0008 008|Ps0008 659|Ps0008 207|Ps0008 252|Ps0008 355|Ps0008 957|Ps0008 927|Ps0008 939|Ps0008 906|Ps0008 900|Ps0008 905|Ps0008 940|Ps0008 917|Ps0008 908|Ps0008 961|Ps0008 932|Ps0008 929|Ps0008 945|Ps0008 931",{"$nulls":3},"UCB Cares","2019-11-07","2020-05-25T16:38:57.191","2020-05-26T17:10:42.972","NCT03412747"]
["5ecbf4a1e2561b1b11905e69","NCT03412747","2019-12-20","UCB","UCBJF","Active, not recruiting","A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis (BE SURE)","Bimekizumab|Adalimumab","IL17A Inhibitor|TNFa Inhibitor","Yes","['Bimekizumab']","No",null,"Phase 3",3,480,"Actual","2018-01-26","2019-02-07","PASI","Psoriasis Area and Severity Index",{"$nulls":3},"This is a study to compare the efficacy of bimekizumab versus adalimumab in the treatment of subjects with moderate to severe chronic plaque psoriasis (PSO).",null,"A Phase 3, Multicenter, Randomized, Double-Blind Study With an Active-Controlled Initial Treatment Period Followed by a Dose-Blind Maintenance Treatment Period to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis","PS0008","Chronic Plaque Psoriasis\nModerate to Severe Plaque Psoriasis","Psoriasis","Dermatological Diseases","Derm & Connective Tissue Disorders","Experimental|Active Comparator","Bimekizumab Arm 1|Bimekizumab Arm 2|Adalimumab Arm","Subjects will receive bimekizumab dose regimen 1 for 56 weeks. Subjects will receive placebo at pre-specified time-points to maintain the blinding.|Subjects will receive bimekizumab dose regimen 1 for 16 weeks and will proceed with bimekizumab dose regimen 2 until week 56. Subjects will receive placebo at pre-specified time-points to maintain the blinding.|Subjects will receive adalimumab for 24 weeks and will then receive bimekizumab dose regimen 1 until week 56. Subjects will receive placebo at pre-specified time-points to maintain the blinding.","Drug","Bimekizumab|Adalimumab","Subjects will receive bimekizumab at pre-defined timepoints in dose regimen 1 and/or dose regimen 2.|Adalimumab will be administered according to the labeling recommendations.","UCB4940\nPlaceboSubjects will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products (IMP).|UCB4940|HumiraÂ®\nPlaceboSubjects will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products (IMP).","Bimekizumab Arm 1|Bimekizumab Arm 2|Adalimumab Arm","\n\n * Must be at least 18 years of age\n * Chronic plaque PSO for at least 6 months prior to the Screening Visit\n * Psoriasis Area Severity Index (PASI) >=12 and body surface area (BSA) affected by PSO >=10% and Investigator's Global Assessment (IGA) score >=3 on a 5-point scale\n * Subject is a candidate for systemic PSO therapy and/or phototherapy\n * Female subject of child bearing potential must be willing to use highly effective method of contraception\n\n","\n\n * Subject has a known hypersensitivity to any excipients of bimekizumab or adalimumab\n * Subject has an active infection (except common cold), a serious infection, or a history of opportunistic or recurrent chronic infections\n * Subject has concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection\n * Subject has known tuberculosis (TB) infection, is at high risk of acquiring TB infection, or has current or history of nontuberculous mycobacterium (NTMB) infection\n * Subject has any other condition, including medical or psychiatric, which, in the Investigator's judgment, would make the subject unsuitable for inclusion in the study\n * Subject has had previous exposure to adalimumab\n * Presence of active suicidal ideation or positive suicide behavior\n * Presence of moderately severe major depression or severe major depression\n * Subject has any active malignancy or history of malignancy within 5 years prior to the Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma, or in situ cervical cancer",{"$nulls":4},"Actual","2018-01-26","Actual","Actual","2020-03-01","Anticipated","2019-12-01","2018-01-22","2018-01-25","2019-12-19","Yes","Bimekizumab\nPSO\nPsoriasis","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"All",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2016-003392-22","EudraCT Number","Psoriasis Area and Severity Index 90 (PASI90) response at Week 16|Investigator's Global Assessment (IGA) response at Week 16","A PASI90 responder is defined as a subject that achieves 90% reduction from Baseline in the PASI score.|IGA response is defined as Clear or Almost Clear with at least a 2-category improvement relative to Baseline.","Week 16","PASI90 response at Week 24|IGA response at Week 24|PASI75 response at Week 4|PASI100 response at Week 16|PASI100 response at Week 24|PASI90 response at Week 56|IGA response at Week 56|Number of Treatment Emergent Adverse Events (TEAEs) adjusted by duration of subject exposure to study treatment|Number of Serious Adverse Events (SAEs) adjusted by duration of subject exposure to study treatment|Number of Treatment Emergent Adverse Events (TEAEs) leading to withdrawal adjusted by duration of subject exposure to study treatment","A PASI90 responder is defined as a subject that achieves 90% reduction from Baseline in the PASI score.|IGA response is defined as Clear or Almost Clear with at least 2-category improvement relative to Baseline.|A PASI75 responder is defined as a subject that achieves 75% reduction from Baseline in the PASI score.|A PASI100 responder is defined as a subject that achieves 100% reduction from Baseline in the PASI score.|The number of TEAEs adjusted by duration of exposure to study treatment is scaled such that it provides an incidence rate per 100 patient-years. If a subject has multiple events, the time of exposure is calculated to the first occurrence of the Adverse Event (AE) being considered. If a subject has no events, the total time at risk is used.|The number of adjusted SAEs by duration of exposure to study treatment is scaled such that it provides an incidence rate per 100 patient-years. If a subject has multiple events, the time of exposure is calculated to the first occurrence of the AE being considered. If a subject has no events, the total time at risk is used.|The number of TEAEs leading to discontinuation adjusted by duration of exposure to study treatment is scaled such that it provides an incidence rate per 100 patient-years. If a subject has multiple events, the time of exposure is calculated to the first occurrence of the AE being considered. If a subject has no events, the total time at risk is used.","Week 24|Week 4|Week 16|Week 56|From Baseline to Safety Follow Up (up to Week 76)",{"$nulls":3},"East Melbourne, Australia Ps0008 004Fremantle, Australia Ps0008 007Hectorville, Australia Ps0008 010Kogarah, Australia Ps0008 005Phillip, Australia Ps0008 009Woolloongabba, Australia|Calgary, Canada Ps0008 663Mississauga, Canada Ps0008 660MontrÃ©al, Canada Ps0008 661Peterborough, Canada Ps0008 662Toronto, Canada Ps0008 664Toronto, Canada Ps0008 657Waterloo, Canada Ps0008 669Windsor, Canada Ps0008 670Windsor, Canada Ps0008 674Winnipeg, Canada|Berlin, Germany Ps0008 218Bonn, Germany Ps0008 203Dresden, Germany Ps0008 211Hamburg, Germany Ps0008 220Hamburg, Germany Ps0008 215Lubeck, Germany Ps0008 213Mahlow, Germany Ps0008 205OsnabrÃ¼ck, Germany Ps0008 217Schweinfurt, Germany|Budapest, Hungary Ps0008 254Budapest, Hungary Ps0008 255Budapest, Hungary Ps0008 256Debrecen, Hungary Ps0008 251Gyula, Hungary Ps0008 260Szeged, Hungary Korea, Republic Of Ps0008 702Gwangju, Korea, Republic Of Ps0008 700Seoul, Korea, Republic Of|BiaÅ‚ystok, Poland Ps0008 362BiaÅ‚ystok, Poland Ps0008 371Bydgoszcz, Poland Ps0008 352GdaÅ„sk, Poland Ps0008 359Katowice, Poland Ps0008 366Katowice, Poland Ps0008 363KrakÃ³w, Poland Ps0008 356Lublin, Poland Ps0008 364Nowa SÃ³l, Poland Ps0008 353Szczecin, Poland Ps0008 354Warszawa, Poland Ps0008 365WrocÅ‚aw, Poland Ps0008 367WrocÅ‚aw, Poland Ps0008 373WrocÅ‚aw, Poland Ps0008 360Å\u0081Ã³dÅº, Poland Ps0008 372Å\u0081Ã³dÅº, Poland Russian Federation Ps0008 405Saint Petersburg, Russian Federation Ps0008 401Saratov, Russian Federation Ps0008 406Yaroslavl, Russian Federation Taiwan Ps0008 754Taipei, Taiwan Ps0008 755Taipei, Taiwan|Glendale, Arizona, United States, 85308|Los Angeles, California, United States, 90033 Ps0008 955San Diego, California, United States, 92123 Ps0008 943San Luis Obispo, California, United States, 93405 Ps0008 967Santa Monica, California, United States, 90404|Danbury, Connecticut, United States, 06810 United States, District Of Columbia Ps0008 934Washington, District Of Columbia, United States, 20037|Boca Raton, Florida, United States, 33486 Ps0008 936Tampa, Florida, United States, 33624|West Des Moines, Iowa, United States, 50265|Overland Park, Kansas, United States, 66215|Beverly, Massachusetts, United States, 01844 Ps0008 925Brighton, Massachusetts, United States, 02135|Troy, Michigan, United States, 48084|East Windsor, New Jersey, United States, 08520|Rocky Mount, North Carolina, United States, 27804 Ps0008 935Winston-Salem, North Carolina, United States, 27104-35 20|Oklahoma City, Oklahoma, United States, 73112|Portland, Oregon, United States, 97223|Greer, South Carolina, United States, 29650|Dallas, Texas, United States, 75231 Ps0008 924Houston, Texas, United States, 77004 Ps0008 951Houston, Texas, United States, 77004","Arizona|California|Connecticut|Florida|Iowa|Kansas|Massachusetts|Michigan|New Jersey|North Carolina|Oklahoma|Oregon|South Carolina|Texas","Australia|Canada|Germany|Hungary|Poland|United States","Ps0008 008|Ps0008 659|Ps0008 207|Ps0008 252|Ps0008 355|Ps0008 957|Ps0008 927|Ps0008 939|Ps0008 906|Ps0008 900|Ps0008 905|Ps0008 940|Ps0008 917|Ps0008 908|Ps0008 961|Ps0008 932|Ps0008 929|Ps0008 945|Ps0008 931",{"$nulls":3},"UCB Cares","2019-12-19","2020-05-25T16:38:57.237","2020-05-26T17:10:42.972","NCT03412747"]
["5ecbf4a111702c1b1b916b7d","NCT03412747","2020-02-11","UCB","UCBJF","Active, not recruiting","A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis (BE SURE)","Bimekizumab|Adalimumab","IL17A Inhibitor|TNFa Inhibitor","Yes","['Bimekizumab']","No",null,"Phase 3",3,480,"Actual","2018-01-26","2019-02-07","PASI","Psoriasis Area and Severity Index",{"$nulls":3},"This is a study to compare the efficacy of bimekizumab versus adalimumab in the treatment of subjects with moderate to severe chronic plaque psoriasis (PSO).",null,"A Phase 3, Multicenter, Randomized, Double-Blind Study With an Active-Controlled Initial Treatment Period Followed by a Dose-Blind Maintenance Treatment Period to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis","PS0008","Chronic Plaque Psoriasis\nModerate to Severe Plaque Psoriasis","Psoriasis","Dermatological Diseases","Derm & Connective Tissue Disorders","Experimental|Active Comparator","Bimekizumab Arm 1|Bimekizumab Arm 2|Adalimumab Arm","Subjects will receive bimekizumab dose regimen 1 for 56 weeks. Subjects will receive placebo at pre-specified time-points to maintain the blinding.|Subjects will receive bimekizumab dose regimen 1 for 16 weeks and will proceed with bimekizumab dose regimen 2 until week 56. Subjects will receive placebo at pre-specified time-points to maintain the blinding.|Subjects will receive adalimumab for 24 weeks and will then receive bimekizumab dose regimen 1 until week 56. Subjects will receive placebo at pre-specified time-points to maintain the blinding.","Drug","Bimekizumab|Adalimumab","Subjects will receive bimekizumab at pre-defined timepoints in dose regimen 1 and/or dose regimen 2.|Adalimumab will be administered according to the labeling recommendations.","UCB4940\nPlaceboSubjects will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products (IMP).|UCB4940|HumiraÂ®\nPlaceboSubjects will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products (IMP).","Bimekizumab Arm 1|Bimekizumab Arm 2|Adalimumab Arm","\n\n * Must be at least 18 years of age\n * Chronic plaque PSO for at least 6 months prior to the Screening Visit\n * Psoriasis Area Severity Index (PASI) >=12 and body surface area (BSA) affected by PSO >=10% and Investigator's Global Assessment (IGA) score >=3 on a 5-point scale\n * Subject is a candidate for systemic PSO therapy and/or phototherapy\n * Female subject of child bearing potential must be willing to use highly effective method of contraception\n\n","\n\n * Subject has a known hypersensitivity to any excipients of bimekizumab or adalimumab\n * Subject has an active infection (except common cold), a serious infection, or a history of opportunistic or recurrent chronic infections\n * Subject has concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection\n * Subject has known tuberculosis (TB) infection, is at high risk of acquiring TB infection, or has current or history of nontuberculous mycobacterium (NTMB) infection\n * Subject has any other condition, including medical or psychiatric, which, in the Investigator's judgment, would make the subject unsuitable for inclusion in the study\n * Subject has had previous exposure to adalimumab\n * Presence of active suicidal ideation or positive suicide behavior\n * Presence of moderately severe major depression or severe major depression\n * Subject has any active malignancy or history of malignancy within 5 years prior to the Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma, or in situ cervical cancer",{"$nulls":4},"Actual","2018-01-26","Actual","Actual","2020-03-01","Anticipated","2020-02-01","2018-01-22","2018-01-25","2020-02-06","Yes","Bimekizumab\nPSO\nPsoriasis","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"All",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":4},"No",null,null,43867,43867,"February 11, 2020 [Actual]",{"$nulls":7},"2016-003392-22","EudraCT Number","Psoriasis Area and Severity Index 90 (PASI90) response at Week 16|Investigator's Global Assessment (IGA) response at Week 16","A PASI90 responder is defined as a subject that achieves 90% reduction from Baseline in the PASI score.|IGA response is defined as Clear or Almost Clear with at least a 2-category improvement relative to Baseline.","Week 16","PASI90 response at Week 24|IGA response at Week 24|PASI75 response at Week 4|PASI100 response at Week 16|PASI100 response at Week 24|PASI90 response at Week 56|IGA response at Week 56|Number of Treatment Emergent Adverse Events (TEAEs) adjusted by duration of subject exposure to study treatment|Number of Serious Adverse Events (SAEs) adjusted by duration of subject exposure to study treatment|Number of Treatment Emergent Adverse Events (TEAEs) leading to withdrawal adjusted by duration of subject exposure to study treatment","A PASI90 responder is defined as a subject that achieves 90% reduction from Baseline in the PASI score.|IGA response is defined as Clear or Almost Clear with at least 2-category improvement relative to Baseline.|A PASI75 responder is defined as a subject that achieves 75% reduction from Baseline in the PASI score.|A PASI100 responder is defined as a subject that achieves 100% reduction from Baseline in the PASI score.|The number of TEAEs adjusted by duration of exposure to study treatment is scaled such that it provides an incidence rate per 100 patient-years. If a subject has multiple events, the time of exposure is calculated to the first occurrence of the Adverse Event (AE) being considered. If a subject has no events, the total time at risk is used.|The number of adjusted SAEs by duration of exposure to study treatment is scaled such that it provides an incidence rate per 100 patient-years. If a subject has multiple events, the time of exposure is calculated to the first occurrence of the AE being considered. If a subject has no events, the total time at risk is used.|The number of TEAEs leading to discontinuation adjusted by duration of exposure to study treatment is scaled such that it provides an incidence rate per 100 patient-years. If a subject has multiple events, the time of exposure is calculated to the first occurrence of the AE being considered. If a subject has no events, the total time at risk is used.","Week 24|Week 4|Week 16|Week 56|From Baseline to Safety Follow Up (up to Week 76)",{"$nulls":3},"East Melbourne, Australia Ps0008 004Fremantle, Australia Ps0008 007Hectorville, Australia Ps0008 010Kogarah, Australia Ps0008 005Phillip, Australia Ps0008 009Woolloongabba, Australia|Calgary, Canada Ps0008 663Mississauga, Canada Ps0008 660MontrÃ©al, Canada Ps0008 661Peterborough, Canada Ps0008 662Toronto, Canada Ps0008 664Toronto, Canada Ps0008 657Waterloo, Canada Ps0008 669Windsor, Canada Ps0008 670Windsor, Canada Ps0008 674Winnipeg, Canada|Berlin, Germany Ps0008 218Bonn, Germany Ps0008 203Dresden, Germany Ps0008 211Hamburg, Germany Ps0008 220Hamburg, Germany Ps0008 215Lubeck, Germany Ps0008 213Mahlow, Germany Ps0008 205OsnabrÃ¼ck, Germany Ps0008 217Schweinfurt, Germany|Budapest, Hungary Ps0008 254Budapest, Hungary Ps0008 255Budapest, Hungary Ps0008 256Debrecen, Hungary Ps0008 251Gyula, Hungary Ps0008 260Szeged, Hungary Korea, Republic Of Ps0008 702Gwangju, Korea, Republic Of Ps0008 700Seoul, Korea, Republic Of|BiaÅ‚ystok, Poland Ps0008 362BiaÅ‚ystok, Poland Ps0008 371Bydgoszcz, Poland Ps0008 352GdaÅ„sk, Poland Ps0008 359Katowice, Poland Ps0008 366Katowice, Poland Ps0008 363KrakÃ³w, Poland Ps0008 356Lublin, Poland Ps0008 364Nowa SÃ³l, Poland Ps0008 353Szczecin, Poland Ps0008 354Warszawa, Poland Ps0008 365WrocÅ‚aw, Poland Ps0008 367WrocÅ‚aw, Poland Ps0008 373WrocÅ‚aw, Poland Ps0008 360Å\u0081Ã³dÅº, Poland Ps0008 372Å\u0081Ã³dÅº, Poland Russian Federation Ps0008 405Saint Petersburg, Russian Federation Ps0008 401Saratov, Russian Federation Ps0008 406Yaroslavl, Russian Federation Taiwan Ps0008 754Taipei, Taiwan Ps0008 755Taipei, Taiwan|Glendale, Arizona, United States, 85308|Los Angeles, California, United States, 90033 Ps0008 955San Diego, California, United States, 92123 Ps0008 943San Luis Obispo, California, United States, 93405 Ps0008 967Santa Monica, California, United States, 90404|Danbury, Connecticut, United States, 06810 United States, District Of Columbia Ps0008 934Washington, District Of Columbia, United States, 20037|Boca Raton, Florida, United States, 33486 Ps0008 936Tampa, Florida, United States, 33624|West Des Moines, Iowa, United States, 50265|Overland Park, Kansas, United States, 66215|Beverly, Massachusetts, United States, 01844 Ps0008 925Brighton, Massachusetts, United States, 02135|Troy, Michigan, United States, 48084|East Windsor, New Jersey, United States, 08520|Rocky Mount, North Carolina, United States, 27804 Ps0008 935Winston-Salem, North Carolina, United States, 27104-35 20|Oklahoma City, Oklahoma, United States, 73112|Portland, Oregon, United States, 97223|Greer, South Carolina, United States, 29650|Dallas, Texas, United States, 75231 Ps0008 924Houston, Texas, United States, 77004 Ps0008 951Houston, Texas, United States, 77004","Arizona|California|Connecticut|Florida|Iowa|Kansas|Massachusetts|Michigan|New Jersey|North Carolina|Oklahoma|Oregon|South Carolina|Texas","Australia|Canada|Germany|Hungary|Poland|United States","Ps0008 008|Ps0008 659|Ps0008 207|Ps0008 252|Ps0008 355|Ps0008 957|Ps0008 927|Ps0008 939|Ps0008 906|Ps0008 900|Ps0008 905|Ps0008 940|Ps0008 917|Ps0008 908|Ps0008 961|Ps0008 932|Ps0008 929|Ps0008 945|Ps0008 931",{"$nulls":3},"UCB Cares","2020-02-06","2020-05-25T16:38:57.524","2020-05-26T17:10:42.972","NCT03412747"]
["5ecbf4a1feab101b155309a0","NCT03412773","2018-01-30","BeiGene","BGNE","Recruiting","Phase 3 Study of BGB-A317 Versus Sorafenib in Patients With Unresectable HCC","Tislelizumab|Sorafenib","PD-1 Inhibitor|TK Inhibitor|VEGFR Inhibitor|RAFk Inhibitor|PGFR Inhibitor|Angiogenesis Inhibitor","Yes","['Tislelizumab']","No",null,"Phase 3",2,660,"Anticipated","2017-12-28","2022-01-01","AUC|DLT|OS|ADA","Area Under The Curve|Dose Limiting Toxicity|Overall Survival|Anti Drug Antibody",{"$nulls":3},"This is a Phase 3, randomized, open-label, multicenter, global study designed to compare the efficacy and safety of BGB-A317 versus sorafenib as a first-line systemic treatment in patients with unresectable hepatocellular carcinoma. This study also includes a substudy investigating the safety, tolerability, PK, and preliminary efficacy in HCC in Japanese patients. In Japan, preliminary safety and tolerability will be evaluated (Safety Run-In Substudy) before Japanese patients are recruited in this Phase 3 study.",null,"A Randomized, Open-label, Multicenter Phase 3 Study to Compare the Efficacy and Safety of BGB-A317 Versus Sorafenib as First-Line Treatment in Patients With Unresectable Hepatocellular Carcinoma","BGB-A317-301","Hepatocellular Carcinoma (HCC)","Noma|Carcinoma|Hepatocellular Carcinoma","Mouth Diseases|Oncology Solid Tumor","Ear, Nose and Throat|Oncology","Experimental|Active Comparator","Arm A: BGB-A317 & Safety Run-In Substudy [Japan Only]|Arm B: Sorafenib",null,"Drug","BGB-A317|Sorafenib","BGB-A317: 200 mg once every 3 weeks (Q3W), intravenous dosing (IV)|Sorafenib: 400 mg twice daily (BID), oral dosing","PD-1 ANTIBODY|Nexavar, BAY43-9006","Arm A: BGB-A317 & Safety Run-In Substudy [Japan Only]|Arm B: Sorafenib","\n\n * 1. Histologically confirmed diagnosis of HCC2. Barcelona Clinic Liver Cancer (BCLC) Stage B or C disease not amenable to or progressing after loco-regional therapy and not amenable to a curative treatment approach\n   \n   3. No prior systemic therapy for HCC (with the exception of HCC patients enrolled in the safety run-in substudy [Japan only])\n   \n   4. Measurable disease\n   \n   5. Child-Pugh score A\n   \n   6. Easter Cooperative Oncology Group (ECOG) Performance Status â‰¤ 1\n   \n   7. Adequate organ function\n   \n   \n\n","\n\n * 1. Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC histology2. Tumor thrombus involving main trunk of portal vein or inferior vena cava\n   \n   3. Loco-regional therapy to the liver within 28 days before randomization\n   \n   4. Clinical evidence of portal hypertension with bleeding esophageal or gastric varices at Screening, or within 6 months before randomization\n   \n   5. Bleeding or thrombotic disorder or any prescribed anticoagulant requiring therapeutic international normalized ratio monitoring (eg, warfarin or similar agents) at Screening, or within 6 months before randomization/enrollment\n   \n   6. Presence at Screening of active immune deficiency or autoimmune disease and/or prior history of any immune deficiency or autoimmune disease that may relapse\n   \n   7. Patient with any condition requiring systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication within 14 days before randomization\n   \n   8. History of interstitial lung disease or non-infectious pneumonitis, unless induced by radiation therapy\n   \n   9. QT interval corrected for heart rate (QTc) (corrected by Fridericia's method) > 450 msec at Screening",{"$nulls":4},"Actual","2018-01-26","Actual","Anticipated","2022-05-01","Anticipated","2018-01-01","2018-01-03","2018-01-21","2018-01-29",null,"Advanced liver cancer","Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":19},"Overall Survival (OS)|Safety Run-In Substudy[Japan only]: Percentage of patients with adverse events|Safety Run-In Substudy[Japan only]: Percentage of patients with dose-limiting toxicities (DLT) [Determination of the pivotal Phase 3 dose of BGB-A317 in Japanese patients]|Safety Run-In Substudy[Japan only]: Maximum Concentration (Cmax) of BGB-A317|Safety Run-In Substudy[Japan only]: Trough Serum Concentration (Cmin) of BGB-A317|Safety Run-In Substudy[Japan only]: Area Under the Curve (AUC) of BGB-A317|Safety Run-In Substudy[Japan only]:Anti-Drug Antibodies (ADA) against BGB-A317 at Cmin|Safety Run-In Substudy[Japan only]: Percentage of Participants With Clinically Significant Changes in Vital Signs Findings|Safety Run-In Substudy[Japan only]: Percentage of Participants With Clinically Significant Changes in Physical Examination Findings|Safety Run-In Substudy[Japan only]: Percentage of Participants With Clinically Significant Changes in Clinical Laboratory Results Findings|Safety Run-In Substudy[Japan only]: Percentage of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Findings","From date of randomization up to 4 years, approximately|From date of enrollment up to 4 years, approximately.|From the date of enrollment up to 28 days|From first dose of study treatment up to 4 years, approximately.","DLT period.","Objective Response Rate (ORR)|Progression-free survival (PFS)|Duration of Response (DOR)|Time to Progression (TTP)|Health-Related Quality of Life (HRQoL)|Disease Control Rate (DCR)|Clinical Benefit Rate (CBR)|Percentage of patients with adverse events|Safety Run-In Substudy[Japan only]: Objective Response Rate (ORR)|Safety Run-In Substudy[Japan only]: Progression-free survival (PFS)|Safety Run-In Substudy[Japan only]: Duration of Response (DOR)|Safety Run-In Substudy[Japan only]: Overall Survival (OS)|Safety Run-In Substudy[Japan only]: Anti-BGB-A317 antibody|Percentage of Participants With Clinically Significant Changes in Vital Signs Findings|Percentage of Participants With Clinically Significant Changes in Physical Examination Findings|Percentage of Participants With Clinically Significant Changes in Clinical Laboratory Results Findings|Percentage of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Findings","From date of randomization up to 4 years, approximately|From first determination of an objective response up to 4 years, approximately|From date of randomization up to 4 years, approximately.|From date of enrollment up to 4 years, approximately.|From first dose of study treatment up to 4 years, approximately|From date of screening up to 4 years, approximately.|From date of randomization up 4 years, approximately|From first dose of study treatment up 4 years, approximately|From date of enrollment up to 4 years, approximately",{"$nulls":4},"Kettering, Ohio, United States, 45409","Ohio","United States","Precision Cancer Research / Dayton Physicians Network",{"$nulls":4},"2018-01-29","2020-05-25T16:38:57.874","2020-05-26T17:10:42.972","NCT03412773"]
["5ecbf4a2e2561b1b11905e6b","NCT03412773","2018-06-18","BeiGene","BGNE","Recruiting","Phase 3 Study of BGB-A317 Versus Sorafenib in Patients With Unresectable HCC","Tislelizumab|Sorafenib","PD-1 Inhibitor|TK Inhibitor|VEGFR Inhibitor|RAFk Inhibitor|PGFR Inhibitor|Angiogenesis Inhibitor","Yes","['Tislelizumab']","No",null,"Phase 3",2,660,"Anticipated","2017-12-28","2022-01-01","AUC|DLT|OS|ADA","Area Under The Curve|Dose Limiting Toxicity|Overall Survival|Anti Drug Antibody",{"$nulls":3},"This is a Phase 3, randomized, open-label, multicenter, global study designed to compare the efficacy and safety of BGB-A317 versus sorafenib as a first-line systemic treatment in patients with unresectable hepatocellular carcinoma. This study also includes a substudy investigating the safety, tolerability, PK, and preliminary efficacy in HCC in Japanese patients. In Japan, preliminary safety and tolerability will be evaluated (Safety Run-In Substudy) before Japanese patients are recruited in this Phase 3 study.",null,"A Randomized, Open-label, Multicenter Phase 3 Study to Compare the Efficacy and Safety of BGB-A317 Versus Sorafenib as First-Line Treatment in Patients With Unresectable Hepatocellular Carcinoma","BGB-A317-301","Hepatocellular Carcinoma (HCC)","Noma|Carcinoma|Hepatocellular Carcinoma","Mouth Diseases|Oncology Solid Tumor","Ear, Nose and Throat|Oncology","Experimental|Active Comparator","Arm A: BGB-A317 & Safety Run-In Substudy [Japan Only]|Arm B: Sorafenib",null,"Drug","BGB-A317|Sorafenib","BGB-A317: 200 mg once every 3 weeks (Q3W), intravenous dosing (IV)|Sorafenib: 400 mg twice daily (BID), oral dosing","PD-1 ANTIBODY|Nexavar, BAY43-9006","Arm A: BGB-A317 & Safety Run-In Substudy [Japan Only]|Arm B: Sorafenib","\n\n * 1. Histologically confirmed diagnosis of HCC2. Barcelona Clinic Liver Cancer (BCLC) Stage B or C disease not amenable to or progressing after loco-regional therapy and not amenable to a curative treatment approach\n   \n   3. No prior systemic therapy for HCC (with the exception of HCC patients enrolled in the safety run-in substudy [Japan only])\n   \n   4. Measurable disease\n   \n   5. Child-Pugh score A\n   \n   6. Easter Cooperative Oncology Group (ECOG) Performance Status â‰¤ 1\n   \n   7. Adequate organ function\n   \n   \n\n","\n\n * 1. Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC histology2. Tumor thrombus involving main trunk of portal vein or inferior vena cava\n   \n   3. Loco-regional therapy to the liver within 28 days before randomization\n   \n   4. Clinical evidence of portal hypertension with bleeding esophageal or gastric varices at Screening, or within 6 months before randomization\n   \n   5. Bleeding or thrombotic disorder or any prescribed anticoagulant requiring therapeutic international normalized ratio monitoring (eg, warfarin or similar agents) at Screening, or within 6 months before randomization/enrollment\n   \n   6. Presence at Screening of active immune deficiency or autoimmune disease and/or prior history of any immune deficiency or autoimmune disease that may relapse\n   \n   7. Patient with any condition requiring systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication within 14 days before randomization\n   \n   8. History of interstitial lung disease or non-infectious pneumonitis, unless induced by radiation therapy\n   \n   9. QT interval corrected for heart rate (QTc) (corrected by Fridericia's method) > 450 msec at Screening",{"$nulls":4},"Actual","2018-01-26","Actual","Anticipated","2022-05-01","Anticipated","2018-06-01","2018-01-03","2018-01-21","2018-06-14",null,"Advanced liver cancer","Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":19},"Overall Survival (OS)|Safety Run-In Substudy[Japan only]: Percentage of patients with adverse events|Safety Run-In Substudy[Japan only]: Percentage of patients with dose-limiting toxicities (DLT) [Determination of the pivotal Phase 3 dose of BGB-A317 in Japanese patients]|Safety Run-In Substudy[Japan only]: Maximum Concentration (Cmax) of BGB-A317|Safety Run-In Substudy[Japan only]: Trough Serum Concentration (Cmin) of BGB-A317|Safety Run-In Substudy[Japan only]: Area Under the Curve (AUC) of BGB-A317|Safety Run-In Substudy[Japan only]:Anti-Drug Antibodies (ADA) against BGB-A317 at Cmin|Safety Run-In Substudy[Japan only]: Percentage of Participants With Clinically Significant Changes in Vital Signs Findings|Safety Run-In Substudy[Japan only]: Percentage of Participants With Clinically Significant Changes in Physical Examination Findings|Safety Run-In Substudy[Japan only]: Percentage of Participants With Clinically Significant Changes in Clinical Laboratory Results Findings|Safety Run-In Substudy[Japan only]: Percentage of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Findings","From date of randomization up to 4 years, approximately|From date of enrollment up to 4 years, approximately.|From the date of enrollment up to 28 days|From first dose of study treatment up to 4 years, approximately.","DLT period.","Objective Response Rate (ORR)|Progression-free survival (PFS)|Duration of Response (DOR)|Time to Progression (TTP)|Health-Related Quality of Life (HRQoL)|Disease Control Rate (DCR)|Clinical Benefit Rate (CBR)|Percentage of patients with adverse events|Safety Run-In Substudy[Japan only]: Objective Response Rate (ORR)|Safety Run-In Substudy[Japan only]: Progression-free survival (PFS)|Safety Run-In Substudy[Japan only]: Duration of Response (DOR)|Safety Run-In Substudy[Japan only]: Overall Survival (OS)|Safety Run-In Substudy[Japan only]: Anti-BGB-A317 antibody|Percentage of Participants With Clinically Significant Changes in Vital Signs Findings|Percentage of Participants With Clinically Significant Changes in Physical Examination Findings|Percentage of Participants With Clinically Significant Changes in Clinical Laboratory Results Findings|Percentage of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Findings","From date of randomization up to 4 years, approximately|From first determination of an objective response up to 4 years, approximately|From date of randomization up to 4 years, approximately.|From date of enrollment up to 4 years, approximately.|From first dose of study treatment up to 4 years, approximately|From date of screening up to 4 years, approximately.|From date of randomization up 4 years, approximately|From first dose of study treatment up 4 years, approximately|From date of enrollment up to 4 years, approximately",{"$nulls":4},"Bengbu, Anhui, China, 233004 The First Affiliated Hospital Of Anhui Medical UniversityHefei, Anhui, China, 230022|Beijing, Beijing, China, 100142 Chinese Pla General HospitalBeijing, Beijing, China, 100853|Fuzhou, Fujian, China, 350001|Guangzhou, Guangdong, China, 510080 Nanfang HospitalGuangzhou, Guangdong, China, 510515|Harbin, Heilongjiang, China, 150081|Zhengzhou, Henan, China, 450008|Wuhan, Hubei, China, 430023|Nanjing, Jiangsu, China, 210002|Nanchang, Jiangxi, China, 330006|Beijing, China, 100730 Tianjin Medical University Cancer Institute And HospitalTianjin, China, 300060|Weifang, Shandong, China, 261000|Shanghai, Shanghai, China, 200032|Xian, Shanxi, China, 710061|Wuhan, Wuhan, China, 430071|Hangzhou, Zhejiang, China, 310016 Zhejiang Cancer HospitalHangzhou, Zhejiang, China, 310022|Yokohama, Kanagawa, Japan, 241-8515|Fukuoka, Japan, 810-8563 Kumamoto University HospitalKumamoto, Japan, 860-8556 Osaka International Cancer InstituteOsaka, Japan, 541-8567|Osaka-Sayama, Osaka, Japan, 589-8511 Osaka University HospitalSuita, Osaka, Japan, 565-0871|Chiyoda-Ku, Tokyo, Japan, 101-0062|Barcelona, Spain, 8035 Taiwan National Cheng Kung University HospitalTainan, Taiwan, 705 Taipei Veterans General HospitalTaipei, Taiwan, 112|Fullerton, California, United States, 92835|Harvey, Illinois, United States, 60426 Healthcare Research Network Iii, LlcTinley Park, Illinois, United States, 60487|Kettering, Ohio, United States, 45409|San Antonio, Texas, United States, 78229","California|Illinois|Ohio|Texas","China|Japan|Spain|United States","Anhui The First Affiliated Hospital Of Bengbu Medical College|Beijing Beijing Cancer Hospital|Fujian Fujian Medical University Union Hospital|Guangdong Guangdong General Hospital|Heilongjiang Harbin Medical University Cancer Hospital|Henan Henan Cancer Hospital|Hubei Wuhan Union Hospital|Jiangsu Nanjing Bayi Hospital|Jiangxi The Second Affiliated Hospital Of Nanchang University|Peking Union Medical College Hospital|Shandong Weifang People's Hospital|Shanghai Shanghai Cancer Hospital Of Fudan University|Shanxi The First Affiliated Hospital Of Xi'An Jiaotong University|Wuhan Zhongnan Hospital Of Wuhan University|Zhejiang Sir Run Run Shaw Hospital, Zhejiang University|Kanagawa Kanagawa Cancer Center|Kyushu Medical Center|Osaka Kinki University Hospital, Faculty Of Medicine - Hematology & Clinical Oncology|Tokyo Sasaki Foundation Kyoundo Hospital|Hospital Universitario Vall D'HebrÃ³n|St. Jude Heritage Healthcare|Ingalls Memorial Hospital|Precision Cancer Research / Dayton Physicians Network|The Mays Cancer Center",{"$nulls":4},"2018-06-14","2020-05-25T16:38:58.045","2020-05-26T17:10:42.972","NCT03412773"]
["5ecbf4a2307e3d1b1f8d9e02","NCT03412773","2018-06-29","BeiGene","BGNE","Recruiting","Phase 3 Study of BGB-A317 Versus Sorafenib in Patients With Unresectable HCC","Tislelizumab|Sorafenib","PD-1 Inhibitor|TK Inhibitor|VEGFR Inhibitor|RAFk Inhibitor|PGFR Inhibitor|Angiogenesis Inhibitor","Yes","['Tislelizumab']","No",null,"Phase 3",2,660,"Anticipated","2017-12-28","2022-01-01","AUC|DLT|OS|ADA","Area Under The Curve|Dose Limiting Toxicity|Overall Survival|Anti Drug Antibody",{"$nulls":3},"This is a Phase 3, randomized, open-label, multicenter, global study designed to compare the efficacy and safety of BGB-A317 versus sorafenib as a first-line systemic treatment in patients with unresectable hepatocellular carcinoma. This study also includes a substudy investigating the safety, tolerability, PK, and preliminary efficacy in HCC in Japanese patients. In Japan, preliminary safety and tolerability will be evaluated (Safety Run-In Substudy) before Japanese patients are recruited in this Phase 3 study.",null,"A Randomized, Open-label, Multicenter Phase 3 Study to Compare the Efficacy and Safety of BGB-A317 Versus Sorafenib as First-Line Treatment in Patients With Unresectable Hepatocellular Carcinoma","BGB-A317-301","Hepatocellular Carcinoma (HCC)","Noma|Carcinoma|Hepatocellular Carcinoma","Mouth Diseases|Oncology Solid Tumor","Ear, Nose and Throat|Oncology","Experimental|Active Comparator","Arm A: BGB-A317 & Safety Run-In Substudy [Japan Only]|Arm B: Sorafenib",null,"Drug","BGB-A317|Sorafenib","BGB-A317: 200 mg once every 3 weeks (Q3W), intravenous dosing (IV)|Sorafenib: 400 mg twice daily (BID), oral dosing","PD-1 ANTIBODY|Nexavar, BAY43-9006","Arm A: BGB-A317 & Safety Run-In Substudy [Japan Only]|Arm B: Sorafenib","\n\n * 1. Histologically confirmed diagnosis of HCC2. Barcelona Clinic Liver Cancer (BCLC) Stage B or C disease not amenable to or progressing after loco-regional therapy and not amenable to a curative treatment approach\n   \n   3. No prior systemic therapy for HCC (with the exception of HCC patients enrolled in the safety run-in substudy [Japan only])\n   \n   4. Measurable disease\n   \n   5. Child-Pugh score A\n   \n   6. Easter Cooperative Oncology Group (ECOG) Performance Status â‰¤ 1\n   \n   7. Adequate organ function\n   \n   \n\n","\n\n * 1. Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC histology2. Tumor thrombus involving main trunk of portal vein or inferior vena cava\n   \n   3. Loco-regional therapy to the liver within 28 days before randomization\n   \n   4. Clinical evidence of portal hypertension with bleeding esophageal or gastric varices at Screening, or within 6 months before randomization\n   \n   5. Bleeding or thrombotic disorder or any prescribed anticoagulant requiring therapeutic international normalized ratio monitoring (eg, warfarin or similar agents) at Screening, or within 6 months before randomization/enrollment\n   \n   6. Presence at Screening of active immune deficiency or autoimmune disease and/or prior history of any immune deficiency or autoimmune disease that may relapse\n   \n   7. Patient with any condition requiring systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication within 14 days before randomization\n   \n   8. History of interstitial lung disease or non-infectious pneumonitis, unless induced by radiation therapy\n   \n   9. QT interval corrected for heart rate (QTc) (corrected by Fridericia's method) > 450 msec at Screening",{"$nulls":4},"Actual","2018-01-26","Actual","Anticipated","2022-05-01","Anticipated","2018-06-01","2018-01-03","2018-01-21","2018-06-27",null,"Advanced liver cancer","Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":19},"Overall Survival (OS)|Safety Run-In Substudy[Japan only]: Percentage of patients with adverse events|Safety Run-In Substudy[Japan only]: Percentage of patients with dose-limiting toxicities (DLT) [Determination of the pivotal Phase 3 dose of BGB-A317 in Japanese patients]|Safety Run-In Substudy[Japan only]: Maximum Concentration (Cmax) of BGB-A317|Safety Run-In Substudy[Japan only]: Trough Serum Concentration (Cmin) of BGB-A317|Safety Run-In Substudy[Japan only]: Area Under the Curve (AUC) of BGB-A317|Safety Run-In Substudy[Japan only]:Anti-Drug Antibodies (ADA) against BGB-A317 at Cmin|Safety Run-In Substudy[Japan only]: Percentage of Participants With Clinically Significant Changes in Vital Signs Findings|Safety Run-In Substudy[Japan only]: Percentage of Participants With Clinically Significant Changes in Physical Examination Findings|Safety Run-In Substudy[Japan only]: Percentage of Participants With Clinically Significant Changes in Clinical Laboratory Results Findings|Safety Run-In Substudy[Japan only]: Percentage of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Findings","From date of randomization up to 4 years, approximately|From date of enrollment up to 4 years, approximately.|From the date of enrollment up to 28 days|From first dose of study treatment up to 4 years, approximately.","DLT period.","Objective Response Rate (ORR)|Progression-free survival (PFS)|Duration of Response (DOR)|Time to Progression (TTP)|Health-Related Quality of Life (HRQoL)|Disease Control Rate (DCR)|Clinical Benefit Rate (CBR)|Percentage of patients with adverse events|Safety Run-In Substudy[Japan only]: Objective Response Rate (ORR)|Safety Run-In Substudy[Japan only]: Progression-free survival (PFS)|Safety Run-In Substudy[Japan only]: Duration of Response (DOR)|Safety Run-In Substudy[Japan only]: Overall Survival (OS)|Safety Run-In Substudy[Japan only]: Anti-BGB-A317 antibody|Percentage of Participants With Clinically Significant Changes in Vital Signs Findings|Percentage of Participants With Clinically Significant Changes in Physical Examination Findings|Percentage of Participants With Clinically Significant Changes in Clinical Laboratory Results Findings|Percentage of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Findings","From date of randomization up to 4 years, approximately|From first determination of an objective response up to 4 years, approximately|From date of randomization up to 4 years, approximately.|From date of enrollment up to 4 years, approximately.|From first dose of study treatment up to 4 years, approximately|From date of screening up to 4 years, approximately.|From date of randomization up 4 years, approximately|From first dose of study treatment up 4 years, approximately|From date of enrollment up to 4 years, approximately",{"$nulls":4},"Bengbu, Anhui, China, 233004 The First Affiliated Hospital Of Anhui Medical UniversityHefei, Anhui, China, 230022|Beijing, Beijing, China, 100142 Chinese Pla General HospitalBeijing, Beijing, China, 100853|Fuzhou, Fujian, China, 350001|Guangzhou, Guangdong, China, 510080 Nanfang HospitalGuangzhou, Guangdong, China, 510515|Harbin, Heilongjiang, China, 150081|Zhengzhou, Henan, China, 450008|Wuhan, Hubei, China, 430023|Nanjing, Jiangsu, China, 210002|Nanchang, Jiangxi, China, 330006|Beijing, China, 100730 Tianjin Medical University Cancer Institute And HospitalTianjin, China, 300060|Weifang, Shandong, China, 261000|Shanghai, Shanghai, China, 200032|Xian, Shanxi, China, 710061|Wuhan, Wuhan, China, 430071|Hangzhou, Zhejiang, China, 310016 Zhejiang Cancer HospitalHangzhou, Zhejiang, China, 310022|Yokohama, Kanagawa, Japan, 241-8515|Fukuoka, Japan, 810-8563 Kumamoto University HospitalKumamoto, Japan, 860-8556 Osaka International Cancer InstituteOsaka, Japan, 541-8567|Osaka-Sayama, Osaka, Japan, 589-8511 Osaka University HospitalSuita, Osaka, Japan, 565-0871|Chiyoda-Ku, Tokyo, Japan, 101-0062|Barcelona, Spain, 8035 Taiwan National Cheng Kung University HospitalTainan, Taiwan, 705 Taipei Veterans General HospitalTaipei, Taiwan, 112|Fullerton, California, United States, 92835|Harvey, Illinois, United States, 60426 Healthcare Research Network Iii, LlcTinley Park, Illinois, United States, 60487|Kettering, Ohio, United States, 45409|San Antonio, Texas, United States, 78229","California|Illinois|Ohio|Texas","China|Japan|Spain|United States","Anhui The First Affiliated Hospital Of Bengbu Medical College|Beijing Beijing Cancer Hospital|Fujian Fujian Medical University Union Hospital|Guangdong Guangdong General Hospital|Heilongjiang Harbin Medical University Cancer Hospital|Henan Henan Cancer Hospital|Hubei Wuhan Union Hospital|Jiangsu Nanjing Bayi Hospital|Jiangxi The Second Affiliated Hospital Of Nanchang University|Peking Union Medical College Hospital|Shandong Weifang People's Hospital|Shanghai Shanghai Cancer Hospital Of Fudan University|Shanxi The First Affiliated Hospital Of Xi'An Jiaotong University|Wuhan Zhongnan Hospital Of Wuhan University|Zhejiang Sir Run Run Shaw Hospital, Zhejiang University|Kanagawa Kanagawa Cancer Center|Kyushu Medical Center|Osaka Kinki University Hospital, Faculty Of Medicine - Hematology & Clinical Oncology|Tokyo Sasaki Foundation Kyoundo Hospital|Hospital Universitario Vall D'HebrÃ³n|St. Jude Heritage Healthcare|Ingalls Memorial Hospital|Precision Cancer Research / Dayton Physicians Network|The Mays Cancer Center",{"$nulls":4},"2018-06-27","2020-05-25T16:38:58.065","2020-05-26T17:10:42.972","NCT03412773"]
["5ecbf4a2307e3d1b1f8d9e04","NCT03412773","2018-10-03","BeiGene","BGNE","Recruiting","Phase 3 Study of BGB-A317 Versus Sorafenib in Patients With Unresectable HCC","Tislelizumab|Sorafenib","PD-1 Inhibitor|TK Inhibitor|VEGFR Inhibitor|RAFk Inhibitor|PGFR Inhibitor|Angiogenesis Inhibitor","Yes","['Tislelizumab']","No",null,"Phase 3",2,660,"Anticipated","2017-12-28","2022-01-01","AUC|DLT|OS|ADA","Area Under The Curve|Dose Limiting Toxicity|Overall Survival|Anti Drug Antibody",{"$nulls":3},"This is a Phase 3, randomized, open-label, multicenter, global study designed to compare the efficacy and safety of BGB-A317 versus sorafenib as a first-line systemic treatment in patients with unresectable hepatocellular carcinoma. This study also includes a substudy investigating the safety, tolerability, PK, and preliminary efficacy in HCC in Japanese patients. In Japan, preliminary safety and tolerability will be evaluated (Safety Run-In Substudy) before Japanese patients are recruited in this Phase 3 study.",null,"A Randomized, Open-label, Multicenter Phase 3 Study to Compare the Efficacy and Safety of BGB-A317 Versus Sorafenib as First-Line Treatment in Patients With Unresectable Hepatocellular Carcinoma","BGB-A317-301","Hepatocellular Carcinoma (HCC)","Noma|Carcinoma|Hepatocellular Carcinoma","Mouth Diseases|Oncology Solid Tumor","Ear, Nose and Throat|Oncology","Experimental|Active Comparator","Arm A: BGB-A317 & Safety Run-In Substudy [Japan Only]|Arm B: Sorafenib",null,"Drug","BGB-A317|Sorafenib","BGB-A317: 200 mg once every 3 weeks (Q3W), intravenous dosing (IV)|Sorafenib: 400 mg twice daily (BID), oral dosing","PD-1 ANTIBODY|Nexavar, BAY43-9006","Arm A: BGB-A317 & Safety Run-In Substudy [Japan Only]|Arm B: Sorafenib","\n\n * 1. Histologically confirmed diagnosis of HCC2. Barcelona Clinic Liver Cancer (BCLC) Stage B or C disease not amenable to or progressing after loco-regional therapy and not amenable to a curative treatment approach\n   \n   3. No prior systemic therapy for HCC (with the exception of HCC patients enrolled in the safety run-in substudy [Japan only])\n   \n   4. Measurable disease\n   \n   5. Child-Pugh score A\n   \n   6. Easter Cooperative Oncology Group (ECOG) Performance Status â‰¤ 1\n   \n   7. Adequate organ function\n   \n   \n\n","\n\n * 1. Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC histology2. Tumor thrombus involving main trunk of portal vein or inferior vena cava\n   \n   3. Loco-regional therapy to the liver within 28 days before randomization\n   \n   4. Clinical evidence of portal hypertension with bleeding esophageal or gastric varices at Screening, or within 6 months before randomization\n   \n   5. Bleeding or thrombotic disorder or any prescribed anticoagulant requiring therapeutic international normalized ratio monitoring (eg, warfarin or similar agents) at Screening, or within 6 months before randomization/enrollment\n   \n   6. Presence at Screening of active immune deficiency or autoimmune disease and/or prior history of any immune deficiency or autoimmune disease that may relapse\n   \n   7. Patient with any condition requiring systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication within 14 days before randomization\n   \n   8. History of interstitial lung disease or non-infectious pneumonitis, unless induced by radiation therapy\n   \n   9. QT interval corrected for heart rate (QTc) (corrected by Fridericia's method) > 450 msec at Screening",{"$nulls":4},"Actual","2018-01-26","Actual","Anticipated","2022-05-01","Anticipated","2018-10-01","2018-01-03","2018-01-21","2018-10-01",null,"Advanced liver cancer","Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":19},"Overall Survival (OS)|Safety Run-In Substudy[Japan only]: Percentage of patients with adverse events|Safety Run-In Substudy[Japan only]: Percentage of patients with dose-limiting toxicities (DLT) [Determination of the pivotal Phase 3 dose of BGB-A317 in Japanese patients]|Safety Run-In Substudy[Japan only]: Maximum Concentration (Cmax) of BGB-A317|Safety Run-In Substudy[Japan only]: Trough Serum Concentration (Cmin) of BGB-A317|Safety Run-In Substudy[Japan only]: Area Under the Curve (AUC) of BGB-A317|Safety Run-In Substudy[Japan only]:Anti-Drug Antibodies (ADA) against BGB-A317 at Cmin|Safety Run-In Substudy[Japan only]: Percentage of Participants With Clinically Significant Changes in Vital Signs Findings|Safety Run-In Substudy[Japan only]: Percentage of Participants With Clinically Significant Changes in Physical Examination Findings|Safety Run-In Substudy[Japan only]: Percentage of Participants With Clinically Significant Changes in Clinical Laboratory Results Findings|Safety Run-In Substudy[Japan only]: Percentage of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Findings","From date of randomization up to 4 years, approximately|From date of enrollment up to 4 years, approximately.|From the date of enrollment up to 28 days|From first dose of study treatment up to 4 years, approximately.","DLT period.","Objective Response Rate (ORR)|Progression-free survival (PFS)|Duration of Response (DOR)|Time to Progression (TTP)|Health-Related Quality of Life (HRQoL)|Disease Control Rate (DCR)|Clinical Benefit Rate (CBR)|Percentage of patients with adverse events|Safety Run-In Substudy[Japan only]: Objective Response Rate (ORR)|Safety Run-In Substudy[Japan only]: Progression-free survival (PFS)|Safety Run-In Substudy[Japan only]: Duration of Response (DOR)|Safety Run-In Substudy[Japan only]: Overall Survival (OS)|Safety Run-In Substudy[Japan only]: Anti-BGB-A317 antibody|Percentage of Participants With Clinically Significant Changes in Vital Signs Findings|Percentage of Participants With Clinically Significant Changes in Physical Examination Findings|Percentage of Participants With Clinically Significant Changes in Clinical Laboratory Results Findings|Percentage of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Findings","From date of randomization up to 4 years, approximately|From first determination of an objective response up to 4 years, approximately|From date of randomization up to 4 years, approximately.|From date of enrollment up to 4 years, approximately.|From first dose of study treatment up to 4 years, approximately|From date of screening up to 4 years, approximately.|From date of randomization up 4 years, approximately|From first dose of study treatment up 4 years, approximately|From date of enrollment up to 4 years, approximately",{"$nulls":4},"Bengbu, Anhui, China, 233004 Anhui Provincial HospitalHefei, Anhui, China, 230001 The First Affiliated Hospital Of Anhui Medical UniversityHefei, Anhui, China, 230022 Anhui Medical University - The Second HospitalHefei, Anhui, China, 230601|Beijing, Beijing, China, 100142 Chinese Pla General HospitalBeijing, Beijing, China, 100853 302 Military Hospital Of|Fuzhou, Fujian, China, 350001 Fujian Provincial Cancer HospitalFuzhou, Fujian, China, 350014|Guangzhou, Guangdong, China, 510080 Nanfang HospitalGuangzhou, Guangdong, China, 510515 Sun Yat-Sen Memorial Hospital , Sun Yat-Sen UniversityGuangzhou, Guangdong, China The First Affiliated Hospital, Sun Yat-Sen UniversityGuangzhou, Guangdong, China|Nanning, Guangxi, China, 530021|Harbin, Heilongjiang, China, 150081|Zhengzhou, Henan, China, 450008|Wuhan, Hubei, China, 400037 Wuhan Union HospitalWuhan, Hubei, China, 430023|Nanjing, Jiangsu, China, 210002 Jiangsu Cancer HospitalNanjing, Jiangsu, China, 210009 The First Affiliated Hospital Of Soochow UniversitySuzhou, Jiangsu, China|Nanchang, Jiangxi, China, 330006|Changchun, Jilin, China The First Hospital Of Jilin UniversityChangchun, Jilin, China|Taichung, Taiwan Taichung Veterans General HospitalTaichung, Taiwan National Cheng Kung University HospitalTainan, Taiwan, 705 Chi Mei Medical Center - YongkangTainan, Taiwan Taipei Veterans General HospitalTaipei, Taiwan, 112 Chang Gung Medical Foundation - Linkou Chang Gung Memorial HospitalTaipei, Taiwan|Beijing, China, 100730 The First Affiliated Hospital Of Chongqing Medical UniversityChongqing, China Tianjin Medical University Cancer Institute And HospitalTianjin, China, 300060|Qingdao, Shandong, China Weifang People'S HospitalWeifang, Shandong, China, 261000|Shanghai, Shanghai, China, 200032 Zhongshan Hospital Fudan UniversityShanghai, Shanghai, China, 200032|Xian, Shanxi, China, 710061|Sichuan, Sichuan, China, 610072|Wuhan, Wuhan, China, 430071|Hangzhou, Zhejiang, China, 310003 Sir Run Run Shaw Hospital, Zhejiang UniversityHangzhou, Zhejiang, China, 310016 Zhejiang Cancer HospitalHangzhou, Zhejiang, China, 310022|BesanÃ§on, Franche-ComtÃ©, France, 25030|Frankfurt/Main, Hessen, Germany|Bonn, Nordrhein-Westfalen, Germany, 53105 Stefan PluntkeEssen, Nordrhein-Westfalen, Germany, 45136|Castellana Grotte, Bari, Italy, 70013|Feltre, Belluno, Italy|Cremona, Italy Aou Policlinico Di ModenaModena, Italy Po Umberto I, Ao Ordine MaurizianoTorino, Italy|Vicenza, Veneto, Italy|Toyoake, Aiti [Aichi], Japan, 470-1192|Matsuyama, Ehime, Japan, 790-0024|Ogaki, Gihu [Gifu], Japan|Sapporo, HokkaidÃ´ [Hokkaido], Japan, 060-8648|Kanazawa-Shi, Isikawa [Ishikawa], Japan, 9208641|Yokohama, Kanagawa, Japan, 232-0024 Kanagawa Cancer CenterYokohama, Kanagawa, Japan, 241-8515|Fukuoka, Japan, 810-8563 Kumamoto University HospitalKumamoto, Japan, 860-8556 Iwate Medical University HospitalMorioka, Japan Hyogo College Of Medicine HospitalNishinomiya-Shi, Japan, 663-8501 Osaka International Cancer InstituteOsaka, Japan, 541-8567 Tottori University HospitalTottori, Japan, 683-8504 Wakayama Medical UniversityWakayama-Shi, Japan, 641-8509|Kyoto-Shi, KyÃ´to [Kyoto], Japan, 602-8566|Omura, Nagasaki, Japan, 856-8562|Osaka-Sayama, Osaka, Japan, 589-8511 Osaka University HospitalSuita, Osaka, Japan, 565-0871|Chiba, Tiba [Chiba], Japan, 260-8677|Chiyoda-Ku, Tokyo, Japan, 101-0062|Itabashi-Ku, TÃ´kyÃ´ [Tokyo], Japan, 173-8610 Jrc Medical CenterShibuya-Ku, TÃ´kyÃ´ [Tokyo], Japan, 150-8935 National Center For Global Health And MedicineShinjuku-Ku, TÃ´kyÃ´ [Tokyo], Japan, 162-8655|Osaka, Ã”saka [Osaka], Japan, 534-0021 Osaka National HospitalOsaka, Ã”saka [Osaka], Japan, 540-0006 Osaka City University HospitalOsaka, Ã”saka [Osaka], Japan, 545-8586|Brno, Brno-MÄ›sto, Slovakia, 625 00|Hospitalet De Llobregat, Barcelona, Spain|Barcelona, Spain, 8035 Hospital Universitari I Politecnic La FeValencia, Spain Taiwan Chang Gung Medical Foundation - Kaohsiung Chang Gung Memorial Hospital - GastroenterologyKaohsiung, Taiwan Kaohsiung Medical University - Chung-Ho Memorial HospitalKaohsiung, Taiwan Tri-Service General Hospital - Neihu BranchNew Taipei, Taiwan|Fullerton, California, United States, 92835 Chao Family Comprehensive Cancer CenterOrange, California, United States, 92868|Harvey, Illinois, United States, 60426 Healthcare Research Network Iii, LlcTinley Park, Illinois, United States, 60487|Boston, Massachusetts, United States, 02114|[Active, Not Recruiting]White Plains, New York, United States, 10601|Kettering, Ohio, United States, 45409|San Antonio, Texas, United States, 78229","California|Illinois|Massachusetts|New York|Ohio|Texas","China|France|Germany|Italy|Japan|Slovakia|Spain|United States","Anhui The First Affiliated Hospital Of Bengbu Medical College|Beijing Beijing Cancer Hospital|Fujian Fujian Medical University Union Hospital|Guangdong Guangdong General Hospital|Guangxi The First Affiliated Hospital Of Guangxi Medical University|Heilongjiang Harbin Medical University Cancer Hospital|Henan Henan Cancer Hospital|Hubei Hubei Cancer Hospital|Jiangsu Nanjing Bayi Hospital|Jiangxi The Second Affiliated Hospital Of Nanchang University|Jilin Jilin Cancer Hospital|Medical University Hospital - Transplantology - Taichung|Peking Union Medical College Hospital|Shandong The Affiliated Hospital Of Qingdao University|Shanghai Shanghai Cancer Hospital Of Fudan University|Shanxi The First Affiliated Hospital Of Xi'An Jiaotong University|Sichuan Sichuan Academy Of Medical Science & Sichuan Provincial People's Hospital|Wuhan Zhongnan Hospital Of Wuhan University|Zhejiang The First Affiliated Hospital Of Zhejiang University|Franche-ComtÃ© Hospitalier Jean Minjoz|Hessen Krankenhaus Nordwest Ggmbh|Nordrhein-Westfalen Maria Gonzalez-Carmona|Bari Irccs Saverio De Bellis, Ao Gastroenterologia|Belluno Medical Oncology|Po Di Cremona, Asst Di Cremona - Oncologia - Cremona - Radiology|Veneto Ospedale S.Bortolo, Aulss N.6 Vicenza|Aiti [Aichi] Fujita Health University Hospital|Ehime Ehime Prefectural Central Hospital - Gastroenterology|Gihu [Gifu] Ogaki Municipal Hospital|HokkaidÃ´ [Hokkaido] Hokkaido University Hospital - Gastroenterology|Isikawa [Ishikawa] Kanazawa University Hospital|Kanagawa Yokohama City University Medical Center|Kyushu Medical Center|KyÃ´to [Kyoto] University Hospital, Kyoto Prefectural Univ Of Medicine|Nagasaki Nagasaki Medical Center|Osaka Kinki University Hospital, Faculty Of Medicine - Hematology & Clinical Oncology|Tiba [Chiba] Chiba University Hospital|Tokyo Sasaki Foundation Kyoundo Hospital|TÃ´kyÃ´ [Tokyo] Nihon University Itabashi Hospital - Gastroenterological Surgery|Ã”saka [Osaka] Osaka City General Hospital|Brno-MÄ›sto Fakultni Nemocnice Brno|Barcelona Institut CatalÃ¡ DÂ´OncologÃ­a (I.C.O.)|Hospital Universitario Vall D'HebrÃ³n|St. Jude Heritage Healthcare|Ingalls Memorial Hospital|Massachusetts General Hospital Cancer Center|White Plains Hospital Center For Cancer Care - Oncology|Precision Cancer Research / Dayton Physicians Network|The Mays Cancer Center",{"$nulls":4},"2018-10-01","2020-05-25T16:38:58.391","2020-05-26T17:10:42.972","NCT03412773"]
["5ecbf4a211702c1b1b916b80","NCT03412773","2019-08-14","BeiGene","BGNE","Recruiting","Phase 3 Study of BGB-A317 Versus Sorafenib in Patients With Unresectable HCC","Tislelizumab|Sorafenib","PD-1 Inhibitor|TK Inhibitor|VEGFR Inhibitor|RAFk Inhibitor|PGFR Inhibitor|Angiogenesis Inhibitor","Yes","['Tislelizumab']","No",null,"Phase 3",2,660,"Anticipated","2017-12-28","2022-01-01","AUC|DLT|OS|ADA","Area Under The Curve|Dose Limiting Toxicity|Overall Survival|Anti Drug Antibody",{"$nulls":3},"This is a Phase 3, randomized, open-label, multicenter, global study designed to compare the efficacy and safety of BGB-A317 versus sorafenib as a first-line systemic treatment in patients with unresectable hepatocellular carcinoma. This study also includes a substudy investigating the safety, tolerability, PK, and preliminary efficacy in HCC in Japanese patients. In Japan, preliminary safety and tolerability will be evaluated (Safety Run-In Substudy) before Japanese patients are recruited in this Phase 3 study.",null,"RATIONALE-301: A Randomized, Open-label, Multicenter Phase 3 Study to Compare the Efficacy and Safety of BGB-A317 Versus Sorafenib as First-Line Treatment in Patients With Unresectable Hepatocellular Carcinoma","BGB-A317-301","Hepatocellular Carcinoma (HCC)","Noma|Carcinoma|Hepatocellular Carcinoma","Mouth Diseases|Oncology Solid Tumor","Ear, Nose and Throat|Oncology","Experimental|Active Comparator","Arm A: BGB-A317 & Safety Run-In Substudy [Japan Only]|Arm B: Sorafenib",null,"Drug","BGB-A317|Sorafenib","BGB-A317: 200 mg once every 3 weeks (Q3W), intravenous dosing (IV)|Sorafenib: 400 mg twice daily (BID), oral dosing","PD-1 ANTIBODY|Nexavar, BAY43-9006","Arm A: BGB-A317 & Safety Run-In Substudy [Japan Only]|Arm B: Sorafenib","\n\n * 1. Histologically confirmed diagnosis of HCC2. Barcelona Clinic Liver Cancer (BCLC) Stage B or C disease not amenable to or progressing after loco-regional therapy and not amenable to a curative treatment approach\n   \n   3. No prior systemic therapy for HCC (with the exception of HCC patients enrolled in the safety run-in substudy [Japan only])\n   \n   4. Measurable disease\n   \n   5. Child-Pugh score A\n   \n   6. Easter Cooperative Oncology Group (ECOG) Performance Status â‰¤ 1\n   \n   7. Adequate organ function\n   \n   \n\n","\n\n * 1. Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC histology2. Tumor thrombus involving main trunk of portal vein or inferior vena cava\n   \n   3. Loco-regional therapy to the liver within 28 days before randomization\n   \n   4. Clinical evidence of portal hypertension with bleeding esophageal or gastric varices at Screening, or within 6 months before randomization\n   \n   5. Bleeding or thrombotic disorder or any prescribed anticoagulant requiring therapeutic international normalized ratio monitoring (eg, warfarin or similar agents) at Screening, or within 6 months before randomization/enrollment\n   \n   6. Presence at Screening of active immune deficiency or autoimmune disease and/or prior history of any immune deficiency or autoimmune disease that may relapse\n   \n   7. Patient with any condition requiring systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication within 14 days before randomization\n   \n   8. History of interstitial lung disease or non-infectious pneumonitis, unless induced by radiation therapy\n   \n   9. QT interval corrected for heart rate (QTc) (corrected by Fridericia's method) > 450 msec at Screening",{"$nulls":4},"Actual","2018-01-26","Actual","Anticipated","2022-05-01","Anticipated","2019-08-01","2018-01-03","2018-01-21","2019-08-12",null,"Advanced liver cancer\nRATIONALE-301","Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"2017-002423-19|CTR20170882","EudraCT Number|Registry Identifier: Center for drug evaluation, CFDA","Overall Survival (OS)|Safety Run-In Substudy[Japan only]: Percentage of patients with adverse events|Safety Run-In Substudy[Japan only]: Percentage of patients with dose-limiting toxicities (DLT) [Determination of the pivotal Phase 3 dose of BGB-A317 in Japanese patients]|Safety Run-In Substudy[Japan only]: Maximum Concentration (Cmax) of BGB-A317|Safety Run-In Substudy[Japan only]: Trough Serum Concentration (Cmin) of BGB-A317|Safety Run-In Substudy[Japan only]: Area Under the Curve (AUC) of BGB-A317|Safety Run-In Substudy[Japan only]:Anti-Drug Antibodies (ADA) against BGB-A317 at Cmin|Safety Run-In Substudy[Japan only]: Percentage of Participants With Clinically Significant Changes in Vital Signs Findings|Safety Run-In Substudy[Japan only]: Percentage of Participants With Clinically Significant Changes in Physical Examination Findings|Safety Run-In Substudy[Japan only]: Percentage of Participants With Clinically Significant Changes in Clinical Laboratory Results Findings|Safety Run-In Substudy[Japan only]: Percentage of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Findings","From date of randomization up to 4 years, approximately|From date of enrollment up to 4 years, approximately.|From the date of enrollment up to 28 days|From first dose of study treatment up to 4 years, approximately.","DLT period.","Objective Response Rate (ORR)|Progression-free survival (PFS)|Duration of Response (DOR)|Time to Progression (TTP)|Health-Related Quality of Life (HRQoL)|Disease Control Rate (DCR)|Clinical Benefit Rate (CBR)|Percentage of patients with adverse events|Safety Run-In Substudy[Japan only]: Objective Response Rate (ORR)|Safety Run-In Substudy[Japan only]: Progression-free survival (PFS)|Safety Run-In Substudy[Japan only]: Duration of Response (DOR)|Safety Run-In Substudy[Japan only]: Overall Survival (OS)|Safety Run-In Substudy[Japan only]: Anti-BGB-A317 antibody|Percentage of Participants With Clinically Significant Changes in Vital Signs Findings|Percentage of Participants With Clinically Significant Changes in Physical Examination Findings|Percentage of Participants With Clinically Significant Changes in Clinical Laboratory Results Findings|Percentage of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Findings","From date of randomization up to 4 years, approximately|From first determination of an objective response up to 4 years, approximately|From date of randomization up to 4 years, approximately.|From date of enrollment up to 4 years, approximately.|From first dose of study treatment up to 4 years, approximately|From date of screening up to 4 years, approximately.|From date of randomization up 4 years, approximately|From first dose of study treatment up 4 years, approximately|From date of enrollment up to 4 years, approximately",{"$nulls":4},"Bengbu, Anhui, China, 233004 Anhui Provincial HospitalHefei, Anhui, China, 230001 The First Affiliated Hospital Of Anhui Medical UniversityHefei, Anhui, China, 230022 Anhui Medical University - The Second HospitalHefei, Anhui, China, 230601|Beijing, Beijing, China, 100142 Chinese Pla General HospitalBeijing, Beijing, China, 100853 302 Military Hospital Of|Fuzhou, Fujian, China, 350001 Fujian Provincial Cancer HospitalFuzhou, Fujian, China, 350014|Guangzhou, Guangdong, China, 510080 Nanfang HospitalGuangzhou, Guangdong, China, 510515 Sun Yat-Sen Memorial Hospital , Sun Yat-Sen UniversityGuangzhou, Guangdong, China The First Affiliated Hospital, Sun Yat-Sen UniversityGuangzhou, Guangdong, China|Nanning, Guangxi, China, 530021|Harbin, Heilongjiang, China, 150081|Zhengzhou, Henan, China, 450008|Wuhan, Hubei, China, 400037 Wuhan Union HospitalWuhan, Hubei, China, 430023|Nanjing, Jiangsu, China, 210002 Jiangsu Cancer HospitalNanjing, Jiangsu, China, 210009 The First Affiliated Hospital Of Soochow UniversitySuzhou, Jiangsu, China|Nanchang, Jiangxi, China, 330006|Changchun, Jilin, China The First Hospital Of Jilin UniversityChangchun, Jilin, China|Taichung, Taiwan Taichung Veterans General HospitalTaichung, Taiwan National Cheng Kung University HospitalTainan, Taiwan, 705 Chi Mei Medical Center - YongkangTainan, Taiwan Taipei Veterans General HospitalTaipei, Taiwan, 112 Chang Gung Medical Foundation - Linkou Chang Gung Memorial HospitalTaipei, Taiwan|Beijing, China, 100730 The First Affiliated Hospital Of Chongqing Medical UniversityChongqing, China Tianjin Medical University Cancer Institute And HospitalTianjin, China, 300060|Qingdao, Shandong, China Weifang People'S HospitalWeifang, Shandong, China, 261000|Shanghai, Shanghai, China, 200032 Zhongshan Hospital Fudan UniversityShanghai, Shanghai, China, 200032|Xian, Shanxi, China, 710061|Sichuan, Sichuan, China, 610072|Wuhan, Wuhan, China, 430071|Hangzhou, Zhejiang, China, 310003 Sir Run Run Shaw Hospital, Zhejiang UniversityHangzhou, Zhejiang, China, 310016 Zhejiang Cancer HospitalHangzhou, Zhejiang, China, 310022|Brno, Brno-Mesto, Czechia, 625 00|Olomouc, Czechia, 779 00 Fakultni Nemocnice V MotolePraha 5, Czechia, 150 06|Somme, Amiens, France, 80054|Caen, Cedex 05, Basse-Normandie, France, 14033|Clichy Cedex, Lie-De-|PlÃ©rin, Bretagne, France, 22190|Reims, Champagne-Ardenne, France, 51100|Villejuif, Lie-De-|BesanÃ§on, Franche-ComtÃ©, France, 25030|La Tronche, Isere, France, 38700|Nantes, Loire-Atlantique, France, 4400|Rahon, Lyon, France, 42270|Lille, Nord, France, 59037|Nice, Provence-Alpes-CÃ´te-D'Azur, France, 3200|Bretagne, Rennes Cedex, France|Villejuif, Val-De-Marne, France, 94805|Poitiers, Vienne, France, 86021|Berlin, Germany, 13353 UniversitÃ¤tsklinikum DÃ¼sseldorfDÃ¼sseldorf, Germany, 40225 Medizinische Hochschule HannoverHannover, Germany, 30625 UniversitÃ¤tsklinikum KÃ¶lnKÃ¶ln, Germany, 50937 UniversitÃ¤tsklinikum Leipzig AÃ¶rLeipzig, Germany, 4103 UniversitÃ¤tsmedizin MainzMainz, Germany|Frankfurt/Main, Hessen, Germany|Bonn, Nordrhein-Westfalen, Germany, 53105 Stefan PluntkeEssen, Nordrhein-Westfalen, Germany, 45136|Castellana Grotte, Bari, Italy, 70013|Feltre, Belluno, Italy|Catania, Catani, Italy, 95123|Bologna, Italy, 40138 Po Di Cremona, Asst Di Cremona - Oncologia - Cremona - RadiologyCremona, Italy Ospedale Vito Fazzi, Asl LecceLecce, Italy, 73100 Aou Policlinico Di ModenaModena, Italy Irccs Policlinico San MatteoPavia, Italy, 27100 Ist. Clinici Scientifici Maugeri - UnitÃ  Operativa Di OncologiaPavia, Italy, 27100 Regina Elena, Istituto Nazionale Dei Tumori, Ifo, IrccsRoma, Italy, 144 Po Umberto I, Ao Ordine MaurizianoTorino, Italy|Vicenza, Veneto, Italy|Toyoake, Aiti [Aichi], Japan, 470-1192|Matsuyama, Ehime, Japan, 790-0024|Ogaki, Gihu [Gifu], Japan|Sapporo, HokkaidÃ´ [Hokkaido], Japan, 060-8648|Kanazawa-Shi, Isikawa [Ishikawa], Japan, 9208641|Yokohama, Kanagawa, Japan, 232-0024 Kanagawa Cancer CenterYokohama, Kanagawa, Japan, 241-8515|Fukuoka, Japan, 810-8563 Kumamoto University HospitalKumamoto, Japan, 860-8556 Iwate Medical University HospitalMorioka, Japan Hyogo College Of Medicine HospitalNishinomiya-Shi, Japan, 663-8501 Osaka International Cancer InstituteOsaka, Japan, 541-8567 Tottori University HospitalTottori, Japan, 683-8504 Wakayama Medical UniversityWakayama-Shi, Japan, 641-8509|Kyoto-Shi, KyÃ´to [Kyoto], Japan, 602-8566|Omura, Nagasaki, Japan, 856-8562|Osaka-Sayama, Osaka, Japan, 589-8511 Osaka University HospitalSuita, Osaka, Japan, 565-0871|Chiba, Tiba [Chiba], Japan, 260-8677|Chiyoda-Ku, Tokyo, Japan, 101-0062|Itabashi-Ku, TÃ´kyÃ´ [Tokyo], Japan, 173-8610 Jrc Medical CenterShibuya-Ku, TÃ´kyÃ´ [Tokyo], Japan, 150-8935 National Center For Global Health And MedicineShinjuku-Ku, TÃ´kyÃ´ [Tokyo], Japan, 162-8655|Osaka, Ã”saka [Osaka], Japan, 534-0021 Osaka National HospitalOsaka, Ã”saka [Osaka], Japan, 540-0006 Osaka City University HospitalOsaka, Ã”saka [Osaka], Japan, 545-8586|Warszawa, Mazowieckie, Poland, 02-781|GdaÅ„sk, Poland, 80-211 Wojewodzki Szpital Specjalistyczny Im. Gromkowskiego We WroclawiuWroclaw, Poland, 51-149|Poznan, Wielkopolskie, Poland, 60-569|Hospitalet De Llobregat, Barcelona, Spain|Barcelona, Spain, 8035 Hospital Universitario Madrid Sanchinarro Centro Integral Oncologico Clara Campal (Ciocc)Madrid, Spain, 28050 Hospital Universitari I Politecnic La FeValencia, Spain Taiwan Chang Gung Medical Foundation - Kaohsiung Chang Gung Memorial Hospital - GastroenterologyKaohsiung, Taiwan Kaohsiung Medical University - Chung-Ho Memorial HospitalKaohsiung, Taiwan Tri-Service General Hospital - Neihu BranchNew Taipei, Taiwan|Birmingham, United Kingdom, B152Th Royal Free Hospital London Nhs TrustLondon, United Kingdom, Nw3 2Qg King'S College Hospital Nhs Foundation TrustLondon, United Kingdom, Se5 9Rs The Christie Nhs Foundation Trust - Oak Road Treatment CentreWithington, United Kingdom, M20 4Bx|Coronado, California, United States, 92118 St. Jude Heritage HealthcareFullerton, California, United States, 92835 University Of California - Hematology And OncologyLos Angeles, California, United States, 90095 Chao Family Comprehensive Cancer CenterOrange, California, United States, 92868 Inland Empire Liver FoundationRialto, California, United States, 92377|Harvey, Illinois, United States, 60426 Healthcare Research Network Iii, LlcTinley Park, Illinois, United States, 60487|New Orleans, Louisiana, United States, 70121-2429 University Medical Center New OrleansNew Orleans, Louisiana, United States, 70121|Boston, Massachusetts, United States, 02114 Umass Memorial Medical CenterWorcester, Massachusetts, United States, 01655|Newark, New Jersey, United States, 07103|Lake Success, New York, United States, 11042 White Plains Hospital Center For Cancer Care - OncologyWhite Plains, New York, United States, 10601|Kettering, Ohio, United States, 45409|Philadelphia, Pennsylvania, United States, 19102 Cancer Treatment Centers Of America - OncologyPhiladelphia, Pennsylvania, United States, 19124|Nashville, Tennessee, United States, 37232|San Antonio, Texas, United States, 78229","California|Illinois|Louisiana|Massachusetts|New Jersey|New York|Ohio|Pennsylvania|Tennessee|Texas","China|Czechia|France|Germany|Italy|Japan|Poland|Spain|United Kingdom|United States","Anhui The First Affiliated Hospital Of Bengbu Medical College|Beijing Beijing Cancer Hospital|Fujian Fujian Medical University Union Hospital|Guangdong Guangdong General Hospital|Guangxi The First Affiliated Hospital Of Guangxi Medical University|Heilongjiang Harbin Medical University Cancer Hospital|Henan Henan Cancer Hospital|Hubei Hubei Cancer Hospital|Jiangsu Nanjing Bayi Hospital|Jiangxi The Second Affiliated Hospital Of Nanchang University|Jilin Jilin Cancer Hospital|Medical University Hospital - Transplantology - Taichung|Peking Union Medical College Hospital|Shandong The Affiliated Hospital Of Qingdao University|Shanghai Shanghai Cancer Hospital Of Fudan University|Shanxi The First Affiliated Hospital Of Xi'An Jiaotong University|Sichuan Sichuan Academy Of Medical Science & Sichuan Provincial People's Hospital|Wuhan Zhongnan Hospital Of Wuhan University|Zhejiang The First Affiliated Hospital Of Zhejiang University|Brno-Mesto Fakultni Nemocnice Brno|Fakultni Nemocnice Olomouc|Amiens Chu Amiens-Hopital Nord - HÃ©pato-GastroentÃ©rologie|Basse-Normandie Chu Cote De Nacre - Hepato-Gastro-Enterologie Et N|Bichat-Beaujon Service Inter Hospitalier De Cancerologie|Bretagne HÃ´pital PrivÃ© Des CÃ´tes D'Armor - Service Oncologie|Champagne-Ardenne Hopital Robert Debre, Chu Reims|France, 92118 Hopital Paul Brousse- Aphp Hopitaux Universitairees Paris Su|Franche-ComtÃ© Hospitalier Jean Minjoz|Isere Chu De Grenoble Alpes|Loire-Atlantique Chu Nantes -Hopital Hotel Dieu|Lyon Chu Saint Etienne|Nord Chru De Lille - HÃ´pital Claude Huriez|Provence-Alpes-CÃ´te-D'Azur Chu De Nice - HÃ´pital De L'Archet Ii|Rennes Cedex Chu Saint Eloi - PÃ´le Digestif|Val-De-Marne Gustave Roussy - Medical Oncology|Vienne Hospital Of Poitiers|CharitÃ© - UniversitÃ¤tsmedizin Berlin Campus Virchow-Klinikum - Hepatologie Und Gastroenterologie|Hessen Krankenhaus Nordwest Ggmbh|Nordrhein-Westfalen Maria Gonzalez-Carmona|Bari Irccs Saverio De Bellis, Ao Gastroenterologia|Belluno Medical Oncology|Catani Po G.Rodolico, Aou Policlinico-Vittorio Emanuele Di Catania|Policlinico S.Orsola Malpighi, Aou Di Bologna - Ssd Malattie|Veneto Ospedale S.Bortolo, Aulss N.6 Vicenza|Aiti [Aichi] Fujita Health University Hospital|Ehime Ehime Prefectural Central Hospital - Gastroenterology|Gihu [Gifu] Ogaki Municipal Hospital|HokkaidÃ´ [Hokkaido] Hokkaido University Hospital - Gastroenterology|Isikawa [Ishikawa] Kanazawa University Hospital|Kanagawa Yokohama City University Medical Center|Kyushu Medical Center|KyÃ´to [Kyoto] University Hospital, Kyoto Prefectural Univ Of Medicine|Nagasaki Nagasaki Medical Center|Osaka Kinki University Hospital, Faculty Of Medicine - Hematology & Clinical Oncology|Tiba [Chiba] Chiba University Hospital|Tokyo Sasaki Foundation Kyoundo Hospital|TÃ´kyÃ´ [Tokyo] Nihon University Itabashi Hospital - Gastroenterological Surgery|Ã”saka [Osaka] Osaka City General Hospital|Mazowieckie Centrum Onkologii Instytut Im. M. Sklodowskiej-Curie|Uniwersyteckie Centrum Kliniczne|Wielkopolskie Clinical Research Center Sp. Z O.O., Medic-R Sp. K.|Barcelona Institut CatalÃ¡ DÂ´OncologÃ­a (I.C.O.)|Hospital Universitario Vall D'HebrÃ³n|Queen Elizabeth Hospital - Clinical Reasearch|Southern California Research Center|Ingalls Memorial Hospital|Ochsner Medical Center (Omc) - New Orleans Accru Network Sit|Massachusetts General Hospital Cancer Center|Umdnj-Njms|Northwell Health/Monter Cancer Center|Precision Cancer Research / Dayton Physicians Network|Hahnemann University Hospital - Gastroenterology Hepatology|Vanderbilt University Medical Center (Vumc)|The Mays Cancer Center",{"$nulls":4},"2019-08-12","2020-05-25T16:38:58.712","2020-05-26T17:10:42.972","NCT03412773"]
["5ecbf4a2e2561b1b11905e6d","NCT03412773","2019-10-16","BeiGene","BGNE","Active, not recruiting","Phase 3 Study of BGB-A317 Versus Sorafenib in Patients With Unresectable HCC","Tislelizumab|Sorafenib","PD-1 Inhibitor|TK Inhibitor|VEGFR Inhibitor|RAFk Inhibitor|PGFR Inhibitor|Angiogenesis Inhibitor","Yes","['Tislelizumab']","No",null,"Phase 3",2,674,"Actual","2017-12-28","2021-06-20","AUC|DLT|OS|ADA","Area Under The Curve|Dose Limiting Toxicity|Overall Survival|Anti Drug Antibody",{"$nulls":3},"This is a Phase 3, randomized, open-label, multicenter, global study designed to compare the efficacy and safety of BGB-A317 versus sorafenib as a first-line systemic treatment in patients with unresectable hepatocellular carcinoma. This study also includes a substudy investigating the safety, tolerability, PK, and preliminary efficacy in HCC in Japanese patients. In Japan, preliminary safety and tolerability will be evaluated (Safety Run-In Substudy) before Japanese patients are recruited in this Phase 3 study.",null,"RATIONALE-301: A Randomized, Open-label, Multicenter Phase 3 Study to Compare the Efficacy and Safety of BGB-A317 Versus Sorafenib as First-Line Treatment in Patients With Unresectable Hepatocellular Carcinoma","BGB-A317-301","Hepatocellular Carcinoma (HCC)","Noma|Carcinoma|Hepatocellular Carcinoma","Mouth Diseases|Oncology Solid Tumor","Ear, Nose and Throat|Oncology","Experimental|Active Comparator","Arm A: BGB-A317 & Safety Run-In Substudy [Japan Only]|Arm B: Sorafenib",null,"Drug","BGB-A317|Sorafenib","BGB-A317: 200 mg once every 3 weeks (Q3W), intravenous dosing (IV)|Sorafenib: 400 mg twice daily (BID), oral dosing","PD-1 ANTIBODY|Nexavar, BAY43-9006","Arm A: BGB-A317 & Safety Run-In Substudy [Japan Only]|Arm B: Sorafenib","\n\n * 1. Histologically confirmed diagnosis of HCC2. Barcelona Clinic Liver Cancer (BCLC) Stage B or C disease not amenable to or progressing after loco-regional therapy and not amenable to a curative treatment approach\n   \n   3. No prior systemic therapy for HCC (with the exception of HCC patients enrolled in the safety run-in substudy [Japan only])\n   \n   4. Measurable disease\n   \n   5. Child-Pugh score A\n   \n   6. Easter Cooperative Oncology Group (ECOG) Performance Status â‰¤ 1\n   \n   7. Adequate organ function\n   \n   \n\n","\n\n * 1. Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC histology2. Tumor thrombus involving main trunk of portal vein or inferior vena cava\n   \n   3. Loco-regional therapy to the liver within 28 days before randomization\n   \n   4. Clinical evidence of portal hypertension with bleeding esophageal or gastric varices at Screening, or within 6 months before randomization\n   \n   5. Bleeding or thrombotic disorder or any prescribed anticoagulant requiring therapeutic international normalized ratio monitoring (eg, warfarin or similar agents) at Screening, or within 6 months before randomization/enrollment\n   \n   6. Presence at Screening of active immune deficiency or autoimmune disease and/or prior history of any immune deficiency or autoimmune disease that may relapse\n   \n   7. Patient with any condition requiring systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication within 14 days before randomization\n   \n   8. History of interstitial lung disease or non-infectious pneumonitis, unless induced by radiation therapy\n   \n   9. QT interval corrected for heart rate (QTc) (corrected by Fridericia's method) > 450 msec at Screening",{"$nulls":4},"Actual","2018-01-26","Actual","Anticipated","2022-05-01","Anticipated","2019-10-01","2018-01-03","2018-01-21","2019-10-14",null,"Advanced liver cancer\nRATIONALE-301","Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"2017-002423-19|CTR20170882","EudraCT Number|Registry Identifier: Center for drug evaluation, CFDA","Overall Survival (OS)|Safety Run-In Substudy[Japan only]: Percentage of patients with adverse events|Safety Run-In Substudy[Japan only]: Percentage of patients with dose-limiting toxicities (DLT) [Determination of the pivotal Phase 3 dose of BGB-A317 in Japanese patients]|Safety Run-In Substudy[Japan only]: Maximum Concentration (Cmax) of BGB-A317|Safety Run-In Substudy[Japan only]: Trough Serum Concentration (Cmin) of BGB-A317|Safety Run-In Substudy[Japan only]: Area Under the Curve (AUC) of BGB-A317|Safety Run-In Substudy[Japan only]:Anti-Drug Antibodies (ADA) against BGB-A317 at Cmin|Safety Run-In Substudy[Japan only]: Percentage of Participants With Clinically Significant Changes in Vital Signs Findings|Safety Run-In Substudy[Japan only]: Percentage of Participants With Clinically Significant Changes in Physical Examination Findings|Safety Run-In Substudy[Japan only]: Percentage of Participants With Clinically Significant Changes in Clinical Laboratory Results Findings|Safety Run-In Substudy[Japan only]: Percentage of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Findings","From date of randomization up to 4 years, approximately|From date of enrollment up to 4 years, approximately.|From the date of enrollment up to 28 days|From first dose of study treatment up to 4 years, approximately.","DLT period.","Objective Response Rate (ORR)|Progression-free survival (PFS)|Duration of Response (DOR)|Time to Progression (TTP)|Health-Related Quality of Life (HRQoL)|Disease Control Rate (DCR)|Clinical Benefit Rate (CBR)|Percentage of patients with adverse events|Safety Run-In Substudy[Japan only]: Objective Response Rate (ORR)|Safety Run-In Substudy[Japan only]: Progression-free survival (PFS)|Safety Run-In Substudy[Japan only]: Duration of Response (DOR)|Safety Run-In Substudy[Japan only]: Overall Survival (OS)|Safety Run-In Substudy[Japan only]: Anti-BGB-A317 antibody|Percentage of Participants With Clinically Significant Changes in Vital Signs Findings|Percentage of Participants With Clinically Significant Changes in Physical Examination Findings|Percentage of Participants With Clinically Significant Changes in Clinical Laboratory Results Findings|Percentage of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Findings","From date of randomization up to 4 years, approximately|From first determination of an objective response up to 4 years, approximately|From date of randomization up to 4 years, approximately.|From date of enrollment up to 4 years, approximately.|From first dose of study treatment up to 4 years, approximately|From date of screening up to 4 years, approximately.|From date of randomization up 4 years, approximately|From first dose of study treatment up 4 years, approximately|From date of enrollment up to 4 years, approximately",{"$nulls":4},"Bengbu, Anhui, China, 233004 Anhui Provincial HospitalHefei, Anhui, China, 230001 The First Affiliated Hospital Of Anhui Medical UniversityHefei, Anhui, China, 230022 Anhui Medical University - The Second HospitalHefei, Anhui, China, 230601|Beijing, Beijing, China, 100142 Chinese Pla General HospitalBeijing, Beijing, China, 100853 302 Military Hospital Of|Fuzhou, Fujian, China, 350001 Fujian Provincial Cancer HospitalFuzhou, Fujian, China, 350014|Guangzhou, Guangdong, China, 510080 Nanfang HospitalGuangzhou, Guangdong, China, 510515 Sun Yat-Sen Memorial Hospital , Sun Yat-Sen UniversityGuangzhou, Guangdong, China The First Affiliated Hospital, Sun Yat-Sen UniversityGuangzhou, Guangdong, China|Nanning, Guangxi, China, 530021|Harbin, Heilongjiang, China, 150081|Zhengzhou, Henan, China, 450008|Wuhan, Hubei, China, 400037 Wuhan Union HospitalWuhan, Hubei, China, 430023|Nanjing, Jiangsu, China, 210002 Jiangsu Cancer HospitalNanjing, Jiangsu, China, 210009 The First Affiliated Hospital Of Soochow UniversitySuzhou, Jiangsu, China|Nanchang, Jiangxi, China, 330006|Changchun, Jilin, China The First Hospital Of Jilin UniversityChangchun, Jilin, China|Taichung, Taiwan Taichung Veterans General HospitalTaichung, Taiwan National Cheng Kung University HospitalTainan, Taiwan, 705 Chi Mei Medical Center - YongkangTainan, Taiwan Taipei Veterans General HospitalTaipei, Taiwan, 112 Chang Gung Medical Foundation - Linkou Chang Gung Memorial HospitalTaipei, Taiwan|Beijing, China, 100730 The First Affiliated Hospital Of Chongqing Medical UniversityChongqing, China Tianjin Medical University Cancer Institute And HospitalTianjin, China, 300060|Qingdao, Shandong, China Weifang People'S HospitalWeifang, Shandong, China, 261000|Shanghai, Shanghai, China, 200032 Zhongshan Hospital Fudan UniversityShanghai, Shanghai, China, 200032|Xian, Shanxi, China, 710061|Sichuan, Sichuan, China, 610072|Wuhan, Wuhan, China, 430071|Hangzhou, Zhejiang, China, 310003 Sir Run Run Shaw Hospital, Zhejiang UniversityHangzhou, Zhejiang, China, 310016 Zhejiang Cancer HospitalHangzhou, Zhejiang, China, 310022|Brno, Brno-Mesto, Czechia, 625 00|Olomouc, Czechia, 779 00 Fakultni Nemocnice V MotolePraha 5, Czechia, 150 06|Somme, Amiens, France, 80054|Caen, Cedex 05, Basse-Normandie, France, 14033|Clichy Cedex, Lie-De-|PlÃ©rin, Bretagne, France, 22190|Reims, Champagne-Ardenne, France, 51100|Villejuif, Lie-De-|BesanÃ§on, Franche-ComtÃ©, France, 25030|La Tronche, Isere, France, 38700|Nantes, Loire-Atlantique, France, 4400|Rahon, Lyon, France, 42270|Lille, Nord, France, 59037|Nice, Provence-Alpes-CÃ´te-D'Azur, France, 3200|Bretagne, Rennes Cedex, France|Villejuif, Val-De-Marne, France, 94805|Poitiers, Vienne, France, 86021|Frankfurt/Main, Hessen, Germany|Bonn, Nordrhein-Westfalen, Germany, 53105 Stefan PluntkeEssen, Nordrhein-Westfalen, Germany, 45136|DÃ¼sseldorf, Germany, 40225 Medizinische Hochschule HannoverHannover, Germany, 30625 UniversitÃ¤tsklinikum KÃ¶lnKÃ¶ln, Germany, 50937 UniversitÃ¤tsklinikum Leipzig AÃ¶rLeipzig, Germany, 4103 UniversitÃ¤tsmedizin MainzMainz, Germany|Castellana Grotte, Bari, Italy, 70013|Feltre, Belluno, Italy|Catania, Catani, Italy, 95123|Bologna, Italy, 40138 Po Di Cremona, Asst Di Cremona - Oncologia - Cremona - RadiologyCremona, Italy Ospedale Vito Fazzi, Asl LecceLecce, Italy, 73100 Aou Policlinico Di ModenaModena, Italy Irccs Policlinico San MatteoPavia, Italy, 27100 Ist. Clinici Scientifici Maugeri - UnitÃ  Operativa Di OncologiaPavia, Italy, 27100 Regina Elena, Istituto Nazionale Dei Tumori, Ifo, IrccsRoma, Italy, 144 Po Umberto I, Ao Ordine MaurizianoTorino, Italy|Vicenza, Veneto, Italy|Toyoake, Aiti [Aichi], Japan, 470-1192|Matsuyama, Ehime, Japan, 790-0024|Ogaki, Gihu [Gifu], Japan|Sapporo, HokkaidÃ´ [Hokkaido], Japan, 060-8648|Kanazawa-Shi, Isikawa [Ishikawa], Japan, 9208641|Yokohama, Kanagawa, Japan, 232-0024 Kanagawa Cancer CenterYokohama, Kanagawa, Japan, 241-8515|Fukuoka, Japan, 810-8563 Kumamoto University HospitalKumamoto, Japan, 860-8556 Iwate Medical University HospitalMorioka, Japan Hyogo College Of Medicine HospitalNishinomiya-Shi, Japan, 663-8501 Osaka International Cancer InstituteOsaka, Japan, 541-8567 Tottori University HospitalTottori, Japan, 683-8504 Wakayama Medical UniversityWakayama-Shi, Japan, 641-8509|Kyoto-Shi, KyÃ´to [Kyoto], Japan, 602-8566|Omura, Nagasaki, Japan, 856-8562|Osaka-Sayama, Osaka, Japan, 589-8511 Osaka University HospitalSuita, Osaka, Japan, 565-0871|Chiba, Tiba [Chiba], Japan, 260-8677|Chiyoda-Ku, Tokyo, Japan, 101-0062|Itabashi-Ku, TÃ´kyÃ´ [Tokyo], Japan, 173-8610 Jrc Medical CenterShibuya-Ku, TÃ´kyÃ´ [Tokyo], Japan, 150-8935 National Center For Global Health And MedicineShinjuku-Ku, TÃ´kyÃ´ [Tokyo], Japan, 162-8655|Osaka, Ã”saka [Osaka], Japan, 534-0021 Osaka National HospitalOsaka, Ã”saka [Osaka], Japan, 540-0006 Osaka City University HospitalOsaka, Ã”saka [Osaka], Japan, 545-8586|Warszawa, Mazowieckie, Poland, 02-781|GdaÅ„sk, Poland, 80-211 Wojewodzki Szpital Specjalistyczny Im. Gromkowskiego We WroclawiuWroclaw, Poland, 51-149|Poznan, Wielkopolskie, Poland, 60-569|Hospitalet De Llobregat, Barcelona, Spain|Barcelona, Spain, 8035 Hospital Universitario Madrid Sanchinarro Centro Integral Oncologico Clara Campal (Ciocc)Madrid, Spain, 28050 Hospital Universitari I Politecnic La FeValencia, Spain Taiwan Chang Gung Medical Foundation - Kaohsiung Chang Gung Memorial Hospital - GastroenterologyKaohsiung, Taiwan Kaohsiung Medical University - Chung-Ho Memorial HospitalKaohsiung, Taiwan Tri-Service General Hospital - Neihu BranchNew Taipei, Taiwan|Birmingham, United Kingdom, B152Th Royal Free Hospital London Nhs TrustLondon, United Kingdom, Nw3 2Qg King'S College Hospital Nhs Foundation TrustLondon, United Kingdom, Se5 9Rs The Christie Nhs Foundation Trust - Oak Road Treatment CentreWithington, United Kingdom, M20 4Bx|Coronado, California, United States, 92118 St. Jude Heritage HealthcareFullerton, California, United States, 92835 University Of California - Hematology And OncologyLos Angeles, California, United States, 90095 Chao Family Comprehensive Cancer CenterOrange, California, United States, 92868 Inland Empire Liver FoundationRialto, California, United States, 92377|Harvey, Illinois, United States, 60426 Healthcare Research Network Iii, LlcTinley Park, Illinois, United States, 60487|New Orleans, Louisiana, United States, 70121-2429 University Medical Center New OrleansNew Orleans, Louisiana, United States, 70121|Boston, Massachusetts, United States, 02114 Umass Memorial Medical CenterWorcester, Massachusetts, United States, 01655|Newark, New Jersey, United States, 07103|Lake Success, New York, United States, 11042 White Plains Hospital Center For Cancer Care - OncologyWhite Plains, New York, United States, 10601|Kettering, Ohio, United States, 45409|Philadelphia, Pennsylvania, United States, 19102 Cancer Treatment Centers Of America - OncologyPhiladelphia, Pennsylvania, United States, 19124|Nashville, Tennessee, United States, 37232|San Antonio, Texas, United States, 78229","California|Illinois|Louisiana|Massachusetts|New Jersey|New York|Ohio|Pennsylvania|Tennessee|Texas","China|Czechia|France|Germany|Italy|Japan|Poland|Spain|United Kingdom|United States","Anhui The First Affiliated Hospital Of Bengbu Medical College|Beijing Beijing Cancer Hospital|Fujian Fujian Medical University Union Hospital|Guangdong Guangdong General Hospital|Guangxi The First Affiliated Hospital Of Guangxi Medical University|Heilongjiang Harbin Medical University Cancer Hospital|Henan Henan Cancer Hospital|Hubei Hubei Cancer Hospital|Jiangsu Nanjing Bayi Hospital|Jiangxi The Second Affiliated Hospital Of Nanchang University|Jilin Jilin Cancer Hospital|Medical University Hospital - Transplantology - Taichung|Peking Union Medical College Hospital|Shandong The Affiliated Hospital Of Qingdao University|Shanghai Shanghai Cancer Hospital Of Fudan University|Shanxi The First Affiliated Hospital Of Xi'An Jiaotong University|Sichuan Sichuan Academy Of Medical Science & Sichuan Provincial People's Hospital|Wuhan Zhongnan Hospital Of Wuhan University|Zhejiang The First Affiliated Hospital Of Zhejiang University|Brno-Mesto Fakultni Nemocnice Brno|Fakultni Nemocnice Olomouc|Amiens Chu Amiens-Hopital Nord - HÃ©pato-GastroentÃ©rologie|Basse-Normandie Chu Cote De Nacre - Hepato-Gastro-Enterologie Et N|Bichat-Beaujon Service Inter Hospitalier De Cancerologie|Bretagne HÃ´pital PrivÃ© Des CÃ´tes D'Armor - Service Oncologie|Champagne-Ardenne Hopital Robert Debre, Chu Reims|France, 92118 Hopital Paul Brousse- Aphp Hopitaux Universitairees Paris Su|Franche-ComtÃ© Hospitalier Jean Minjoz|Isere Chu De Grenoble Alpes|Loire-Atlantique Chu Nantes -Hopital Hotel Dieu|Lyon Chu Saint Etienne|Nord Chru De Lille - HÃ´pital Claude Huriez|Provence-Alpes-CÃ´te-D'Azur Chu De Nice - HÃ´pital De L'Archet Ii|Rennes Cedex Chu Saint Eloi - PÃ´le Digestif|Val-De-Marne Gustave Roussy - Medical Oncology|Vienne Hospital Of Poitiers|Hessen Krankenhaus Nordwest Ggmbh|Nordrhein-Westfalen Maria Gonzalez-Carmona|UniversitÃ¤tsklinikum DÃ¼sseldorf|Bari Irccs Saverio De Bellis, Ao Gastroenterologia|Belluno Medical Oncology|Catani Po G.Rodolico, Aou Policlinico-Vittorio Emanuele Di Catania|Policlinico S.Orsola Malpighi, Aou Di Bologna - Ssd Malattie|Veneto Ospedale S.Bortolo, Aulss N.6 Vicenza|Aiti [Aichi] Fujita Health University Hospital|Ehime Ehime Prefectural Central Hospital - Gastroenterology|Gihu [Gifu] Ogaki Municipal Hospital|HokkaidÃ´ [Hokkaido] Hokkaido University Hospital - Gastroenterology|Isikawa [Ishikawa] Kanazawa University Hospital|Kanagawa Yokohama City University Medical Center|Kyushu Medical Center|KyÃ´to [Kyoto] University Hospital, Kyoto Prefectural Univ Of Medicine|Nagasaki Nagasaki Medical Center|Osaka Kinki University Hospital, Faculty Of Medicine - Hematology & Clinical Oncology|Tiba [Chiba] Chiba University Hospital|Tokyo Sasaki Foundation Kyoundo Hospital|TÃ´kyÃ´ [Tokyo] Nihon University Itabashi Hospital - Gastroenterological Surgery|Ã”saka [Osaka] Osaka City General Hospital|Mazowieckie Centrum Onkologii Instytut Im. M. Sklodowskiej-Curie|Uniwersyteckie Centrum Kliniczne|Wielkopolskie Clinical Research Center Sp. Z O.O., Medic-R Sp. K.|Barcelona Institut CatalÃ¡ DÂ´OncologÃ­a (I.C.O.)|Hospital Universitario Vall D'HebrÃ³n|Queen Elizabeth Hospital - Clinical Reasearch|Southern California Research Center|Ingalls Memorial Hospital|Ochsner Medical Center (Omc) - New Orleans Accru Network Sit|Massachusetts General Hospital Cancer Center|Umdnj-Njms|Northwell Health/Monter Cancer Center|Precision Cancer Research / Dayton Physicians Network|Hahnemann University Hospital - Gastroenterology Hepatology|Vanderbilt University Medical Center (Vumc)|The Mays Cancer Center",{"$nulls":4},"2019-10-14","2020-05-25T16:38:58.470","2020-05-26T17:10:42.972","NCT03412773"]
["5ecbf4a311702c1b1b916b81","NCT03412799","2018-01-26","Sun BioPharma","SNBP","Not yet recruiting","Study of SBP-101 Combined With Nab-Paclitaxel and Gemcitabine in Pancreatic Cancer","Sbp-101|Paclitaxel|Gemcitabine","Tubulin Inhibitor|DNA Synthesis Inhibitor","Yes","['Sbp-101']","No",null,"Phase 1",null,24,"Anticipated","2018-02-01","2019-08-01",{"$nulls":5},"This is an open-label phase 1A/1B study to assess the safety, tolerability and pharmacokinetics of SBP-101 when combined with nab-paclitaxel and gemcitabine in subjects with previously untreated metastatic pancreatic ductal adenocarcinoma and to identify a recommended phase 2 dose. The study will also assess preliminary efficacy of the 3-drug treatment combination.","The study will be conducted in two phases: dose escalation and expansion. Up to three dose levels of SBP-101 will be assessed in up to 18 subjects during dose escalation. The expansion phase of the study will consist of 10 additional subjects who will receive the recommended dose of SBP-101 combined with nab-paclitaxel and gemcitabine.","Phase 1A/1B Dose Escalation and Expansion Study of SBP-101 in Combination With Nab-Paclitaxel and Gemcitabine in Subjects With Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma","CL-SBP-101-03","Pancreatic Cancer Metastatic\nPancreatic Cancer Stage IV\nStage IV Pancreatic Cancer","Pancreatic Cancer","Oncology Solid Tumor","Oncology",{"$nulls":3},"Drug","SBP-101|nab-paclitaxel|Gemcitabine Injection","Administered as subcutaneous (SC) injection, escalating dose cohorts|Administered as intravenous (IV) infusion","diethyl dihydroxyhomospermine | [(HO)2-DEHSPM]|abraxane | protein-bound paclitaxel|gemcitabine hydrochloride | Gemzar",null,"\n\n * Histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma. Patients with pancreatic acinar cell carcinoma may also be included.\n * Is previously untreated for metastatic pancreatic ductal adenocarcinoma, was diagnosed within the past 3 months, and is expected to receive standard treatment with gemcitabine and nab-paclitaxel.\n * Measurable disease on CT or MRI scan by RECIST v 1.1 criteria.\n * ECOG Performance Status 0 or 1.\n * Adult, age â‰¥ 18 years, male or female.\n * Females of child-bearing potential must have a negative serum pregnancy test within 14 days prior to start of study treatment and must use an adequate method of contraception during the study. All sexually active males must also use an adequate method of contraception during the study. Female subjects will be considered to be of childbearing potential unless they are postmenopausal (at least 12 months of consecutive amenorrhea, without other known or suspected cause) and over 55 years old or have been sterilized surgically (i.e., bilateral tubal ligation, hysterectomy or bilateral oophorectomy, all with surgery at least one month before dosing).\n * Adequate bone marrow, hepatic, renal and coagulation function as defined by the following: 1. Absolute neutrophil count â‰¥1.5 x 109/L\n    2. Hemoglobin â‰¥9.0 g/dL (90 g/L)\n    3. Platelets â‰¥100 x 109/L\n    4. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) â‰¤2.5 x upper limit of normal (ULN) (if no hepatic metastases). If hepatic tumor involvement, AST and ALT â‰¤5 x ULN.\n    5. Bilirubin â‰¤1.5 x ULN\n    6. Prothrombin time (PT) / international normalized ratio (INR) â‰¤1.5 x ULN if not on anti-coagulants\n    7. Calculated creatinine clearance >50 mL/min using the Cockcroft and Gault equation\n   \n   \n * QTc interval â‰¤ 470 msec at Baseline.\n * Life expectancy â‰¥ 3 months.\n * Willing and able to provide written informed consent: voluntary agreement to participate in the study following disclosure of risks and procedures required, including possibility of onset of exocrine pancreatic insufficiency with subsequent requirement for life-long pancreatic enzyme replacement.\n\n","\n\n * Evidence of severe or uncontrolled systemic disease or any concurrent condition that, in the opinion of the Investigator or Medical Monitor, makes it undesirable for the subject to participate in the study or that would jeopardize compliance with the protocol. Subjects with pre-existing well-controlled diabetes are not excluded.\n * Medical or psychiatric conditions that compromise the subject's ability to give informed consent or to complete the protocol or a history of non-compliance\n * Presence of islet-cell or pancreatic neuroendocrine tumor or mixed adenocarcinoma-neuroendocrine carcinoma\n * Have symptomatic central nervous system (CNS) malignancy or metastasis. Screening of asymptomatic subjects without history of CNS metastases is not required.\n * Serum albumin <30 g/L (3.0 g/dL)\n * Glycosylated hemoglobin (Hgb A1C) â‰¥ 8.0%\n * Evidence of deep vein thrombosis or pulmonary embolism or other thromboembolic event during screening\n * Presence of known active bacterial, fungal, or viral infection requiring systemic therapy\n * Concomitant use of drugs or supplements known to influence the expression and function of CYP3A4 and/or CYP2C8\n * Known active infection with human immunodeficiency virus (HIV), hepatitis B or C\n * Presence of interstitial lung disease, pulmonary fibrosis, or pulmonary hypersensitivity reaction\n * Myocardial infarction within the last 12 months, severe/unstable angina, symptomatic congestive heart failure New York Heart Association (NYHA) class III or IV\n * Maldigestion/malabsorption syndrome pre-dating the diagnosis of pancreatic cancer.\n * Pregnant or lactating\n * Major surgery within 4 weeks of the start of study treatment, without complete recovery\n * Known hypersensitivity to any component of study treatments\n * Participation in any other clinical investigation within 4 weeks of receiving the first dose of study drug",{"$nulls":4},"Actual","2018-01-26","Actual","Anticipated","2019-08-01","Anticipated","2018-01-01","2018-01-19","2018-01-25","2018-01-25","Yes",null,"Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":19},"Recommended dose of SBP-101","Up to 12 months following the first dose of treatment",null,"Number of subjects with adverse events as a measure of safety and tolerability|Tumor response will be evaluated on RECIST definitions|Area under the plasma concentration versus time curve (AUC) for all three drugs|Peak plasma concentration (Cmax) for all three drugs","Up to 24 months following the first dose of treatment|Every 8 weeks during treatment assessed up to 24 months|Day 1 of Cycle 1",{"$nulls":12},"2018-01-25","2020-05-25T16:38:59.086","2020-05-26T17:10:42.972","NCT03412799"]
["5ecbf4a3feab101b155309a4","NCT03412799","2018-05-14","Sun BioPharma","SNBP","Recruiting","Study of SBP-101 Combined With Nab-Paclitaxel and Gemcitabine in Pancreatic Cancer","Sbp-101|Paclitaxel|Gemcitabine","Tubulin Inhibitor|DNA Synthesis Inhibitor","Yes","['Sbp-101']","No",null,"Phase 1",null,24,"Anticipated","2018-05-01","2019-08-01",{"$nulls":5},"This is an open-label phase 1A/1B study to assess the safety, tolerability and pharmacokinetics of SBP-101 when combined with nab-paclitaxel and gemcitabine in subjects with previously untreated metastatic pancreatic ductal adenocarcinoma and to identify a recommended phase 2 dose. The study will also assess preliminary efficacy of the 3-drug treatment combination.","The study will be conducted in two phases: dose escalation and expansion. Up to three dose levels of SBP-101 will be assessed in up to 18 subjects during dose escalation. The expansion phase of the study will consist of 10 additional subjects who will receive the recommended dose of SBP-101 combined with nab-paclitaxel and gemcitabine.","Phase 1A/1B Dose Escalation and Expansion Study of SBP-101 in Combination With Nab-Paclitaxel and Gemcitabine in Subjects With Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma","CL-SBP-101-03","Pancreatic Cancer Metastatic\nPancreatic Cancer Stage IV\nStage IV Pancreatic Cancer","Pancreatic Cancer","Oncology Solid Tumor","Oncology",{"$nulls":3},"Drug","SBP-101|nab-paclitaxel|Gemcitabine Injection","Administered as subcutaneous (SC) injection, escalating dose cohorts|Administered as intravenous (IV) infusion","diethyl dihydroxyhomospermine | [(HO)2-DEHSPM]|abraxane | protein-bound paclitaxel|gemcitabine hydrochloride | Gemzar",null,"\n\n * Histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma. Patients with pancreatic acinar cell carcinoma may also be included.\n * Is previously untreated for metastatic pancreatic ductal adenocarcinoma, was diagnosed within the past 3 months, and is expected to receive standard treatment with gemcitabine and nab-paclitaxel.\n * Measurable disease on CT or MRI scan by RECIST v 1.1 criteria.\n * ECOG Performance Status 0 or 1.\n * Adult, age â‰¥ 18 years, male or female.\n * Females of child-bearing potential must have a negative serum pregnancy test within 14 days prior to start of study treatment and must use an adequate method of contraception during the study. All sexually active males must also use an adequate method of contraception during the study. Female subjects will be considered to be of childbearing potential unless they are postmenopausal (at least 12 months of consecutive amenorrhea, without other known or suspected cause) and over 55 years old or have been sterilized surgically (i.e., bilateral tubal ligation, hysterectomy or bilateral oophorectomy, all with surgery at least one month before dosing).\n * Adequate bone marrow, hepatic, renal and coagulation function as defined by the following: 1. Absolute neutrophil count â‰¥1.5 x 109/L\n    2. Hemoglobin â‰¥9.0 g/dL (90 g/L)\n    3. Platelets â‰¥100 x 109/L\n    4. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) â‰¤2.5 x upper limit of normal (ULN) (if no hepatic metastases). If hepatic tumor involvement, AST and ALT â‰¤5 x ULN.\n    5. Bilirubin â‰¤1.5 x ULN\n    6. Prothrombin time (PT) / international normalized ratio (INR) â‰¤1.5 x ULN if not on anti-coagulants\n    7. Calculated creatinine clearance >50 mL/min using the Cockcroft and Gault equation\n   \n   \n * QTc interval â‰¤ 470 msec at Baseline.\n * Life expectancy â‰¥ 3 months.\n * Willing and able to provide written informed consent: voluntary agreement to participate in the study following disclosure of risks and procedures required, including possibility of onset of exocrine pancreatic insufficiency with subsequent requirement for life-long pancreatic enzyme replacement.\n\n","\n\n * Evidence of severe or uncontrolled systemic disease or any concurrent condition that, in the opinion of the Investigator or Medical Monitor, makes it undesirable for the subject to participate in the study or that would jeopardize compliance with the protocol. Subjects with pre-existing well-controlled diabetes are not excluded.\n * Medical or psychiatric conditions that compromise the subject's ability to give informed consent or to complete the protocol or a history of non-compliance\n * Presence of islet-cell or pancreatic neuroendocrine tumor or mixed adenocarcinoma-neuroendocrine carcinoma\n * Have symptomatic central nervous system (CNS) malignancy or metastasis. Screening of asymptomatic subjects without history of CNS metastases is not required.\n * Serum albumin <30 g/L (3.0 g/dL)\n * Glycosylated hemoglobin (Hgb A1C) â‰¥ 8.0%\n * Evidence of deep vein thrombosis or pulmonary embolism or other thromboembolic event during screening\n * Presence of known active bacterial, fungal, or viral infection requiring systemic therapy\n * Concomitant use of drugs or supplements known to influence the expression and function of CYP3A4 and/or CYP2C8\n * Known active infection with human immunodeficiency virus (HIV), hepatitis B or C\n * Presence of interstitial lung disease, pulmonary fibrosis, or pulmonary hypersensitivity reaction\n * Myocardial infarction within the last 12 months, severe/unstable angina, symptomatic congestive heart failure New York Heart Association (NYHA) class III or IV\n * Maldigestion/malabsorption syndrome pre-dating the diagnosis of pancreatic cancer.\n * Pregnant or lactating\n * Major surgery within 4 weeks of the start of study treatment, without complete recovery\n * Known hypersensitivity to any component of study treatments\n * Participation in any other clinical investigation within 4 weeks of receiving the first dose of study drug",{"$nulls":4},"Actual","2018-01-26","Actual","Anticipated","2019-08-01","Anticipated","2018-05-01","2018-01-19","2018-01-25","2018-05-11","Yes",null,"Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":19},"Recommended dose of SBP-101","Up to 12 months following the first dose of treatment",null,"Number of subjects with adverse events as a measure of safety and tolerability|Tumor response will be evaluated on RECIST definitions|Area under the plasma concentration versus time curve (AUC) for all three drugs|Peak plasma concentration (Cmax) for all three drugs","Up to 24 months following the first dose of treatment|Every 8 weeks during treatment assessed up to 24 months|Day 1 of Cycle 1",null,"ssmith@couranteoncology.com","Sheri Smith","952-908-9986","Kurralta Park, South|Gainesville, Florida, United States, 32610","Florida","Australia|United States","Ashford Cancer Centre|University Of Florida","tgroene@sunbiopharma.com","Tammy Groene","952-479-1196","Suzanne Gagnon, MD","2018-05-11","2020-05-25T16:38:59.524","2020-05-26T17:10:42.972","NCT03412799"]
["5ecbf4a3fe30261b1a048375","NCT03412799","2019-09-18","Sun BioPharma","SNBP","Recruiting","Study of SBP-101 Combined With Nab-Paclitaxel and Gemcitabine in Pancreatic Cancer","Sbp-101|Paclitaxel|Gemcitabine","Tubulin Inhibitor|DNA Synthesis Inhibitor","Yes","['Sbp-101']","No",null,"Phase 1",null,24,"Anticipated","2018-06-04","2020-03-01",{"$nulls":5},"This is an open-label phase 1A/1B study to assess the safety, tolerability and pharmacokinetics of SBP-101 when combined with nab-paclitaxel and gemcitabine in subjects with previously untreated metastatic pancreatic ductal adenocarcinoma and to identify a recommended phase 2 dose. The study will also assess preliminary efficacy of the 3-drug treatment combination.","The study will be conducted in two phases: dose escalation and expansion. Up to three dose levels of SBP-101 will be assessed in up to 18 subjects during dose escalation. The expansion phase of the study will consist of 10 additional subjects who will receive the recommended dose of SBP-101 combined with nab-paclitaxel and gemcitabine.","Phase 1A/1B Dose Escalation and Expansion Study of SBP-101 in Combination With Nab-Paclitaxel and Gemcitabine in Subjects With Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma","CL-SBP-101-03","Pancreatic Cancer Metastatic\nPancreatic Cancer Stage IV\nStage IV Pancreatic Cancer","Pancreatic Cancer","Oncology Solid Tumor","Oncology",{"$nulls":3},"Drug","SBP-101|nab-paclitaxel|Gemcitabine Injection","Administered as subcutaneous (SC) injection, escalating dose cohorts|Administered as intravenous (IV) infusion","diethyl dihydroxyhomospermine | [(HO)2-DEHSPM]|abraxane | protein-bound paclitaxel|gemcitabine hydrochloride | Gemzar",null,"\n\n * Histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma. Patients with pancreatic acinar cell carcinoma may also be included.\n * Is previously untreated for metastatic pancreatic ductal adenocarcinoma, was diagnosed within the past 3 months, and is expected to receive standard treatment with gemcitabine and nab-paclitaxel.\n * Measurable disease on CT or MRI scan by RECIST v 1.1 criteria.\n * ECOG Performance Status 0 or 1.\n * Adult, age â‰¥ 18 years, male or female.\n * Females of child-bearing potential must have a negative serum pregnancy test within 14 days prior to start of study treatment and must use an adequate method of contraception during the study. All sexually active males must also use an adequate method of contraception during the study. Female subjects will be considered to be of childbearing potential unless they are postmenopausal (at least 12 months of consecutive amenorrhea, without other known or suspected cause) and over 55 years old or have been sterilized surgically (i.e., bilateral tubal ligation, hysterectomy or bilateral oophorectomy, all with surgery at least one month before dosing).\n * Adequate bone marrow, hepatic, renal and coagulation function as defined by the following: 1. Absolute neutrophil count â‰¥1.5 x 109/L\n    2. Hemoglobin â‰¥9.0 g/dL (90 g/L)\n    3. Platelets â‰¥100 x 109/L\n    4. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) â‰¤2.5 x upper limit of normal (ULN) (if no hepatic metastases). If hepatic tumor involvement, AST and ALT â‰¤5 x ULN.\n    5. Bilirubin â‰¤1.5 x ULN\n    6. Prothrombin time (PT) / international normalized ratio (INR) â‰¤1.5 x ULN if not on anti-coagulants\n    7. Calculated creatinine clearance >50 mL/min using the Cockcroft and Gault equation\n   \n   \n * QTc interval â‰¤ 470 msec at Baseline.\n * Life expectancy â‰¥ 3 months.\n * Willing and able to provide written informed consent: voluntary agreement to participate in the study following disclosure of risks and procedures required, including possibility of onset of exocrine pancreatic insufficiency with subsequent requirement for life-long pancreatic enzyme replacement.\n\n","\n\n * Evidence of severe or uncontrolled systemic disease or any concurrent condition that, in the opinion of the Investigator or Medical Monitor, makes it undesirable for the subject to participate in the study or that would jeopardize compliance with the protocol. Subjects with pre-existing well-controlled diabetes are not excluded.\n * Medical or psychiatric conditions that compromise the subject's ability to give informed consent or to complete the protocol or a history of non-compliance\n * Presence of islet-cell or pancreatic neuroendocrine tumor or mixed adenocarcinoma-neuroendocrine carcinoma\n * Have symptomatic central nervous system (CNS) malignancy or metastasis. Screening of asymptomatic subjects without history of CNS metastases is not required.\n * Serum albumin <30 g/L (3.0 g/dL)\n * Evidence of deep vein thrombosis or pulmonary embolism or other thromboembolic event during screening\n * Presence of known active bacterial, fungal, or viral infection requiring systemic therapy\n * Known active infection with human immunodeficiency virus (HIV), hepatitis B or C\n * Presence of interstitial lung disease, pulmonary fibrosis, or pulmonary hypersensitivity reaction\n * Myocardial infarction within the last 12 months, severe/unstable angina, symptomatic congestive heart failure New York Heart Association (NYHA) class III or IV\n * Maldigestion/malabsorption syndrome pre-dating the diagnosis of pancreatic cancer.\n * Pregnant or lactating\n * Major surgery within 4 weeks of the start of study treatment, without complete recovery\n * Known hypersensitivity to any component of study treatments\n * Participation in any other clinical investigation within 4 weeks of receiving the first dose of study drug\n * Subjects taking metformin. Diabetics on treatment with metformin, or any other derivative thereof, must discontinue it while on study. (Other diabetic medications are allowed.)",{"$nulls":4},"Actual","2018-01-26","Actual","Anticipated","2020-12-01","Anticipated","2019-09-01","2018-01-19","2018-01-25","2019-09-17","Yes",null,"Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":19},"Recommended dose of SBP-101","Up to 12 months following the first dose of treatment",null,"Number of subjects with adverse events as a measure of safety and tolerability|Tumor response will be evaluated on RECIST definitions|Area under the plasma concentration versus time curve (AUC) for all three drugs|Peak plasma concentration (Cmax) for all three drugs","Up to 24 months following the first dose of treatment|Every 8 weeks during treatment assessed up to 24 months|Day 1 of Cycle 1",null,"ssmith@couranteoncology.com","Sheri Smith","952-908-9986","Kurralta Park, South|Blacktown, New South Wales, Australia, 2148|Tugun, Queensland, Australia, 4224|Heidelberg, Victoria, Australia, 3084|Gainesville, Florida, United States, 32610|Rochester, New York, United States, 14642","Florida|New York","Australia|United States","Ashford Cancer Centre|New South Wales Blacktown Cancer & Haematology Centre|Queensland John Flynn Private Hospital|Victoria Austin Health|University Of Florida|University Of Rochester Medical Center","tgroene@sunbiopharma.com","Tammy Groene","952-479-1196","Suzanne Gagnon, MD","2019-09-17","2020-05-25T16:38:59.409","2020-05-26T17:10:42.972","NCT03412799"]
["5ecbf4a3307e3d1b1f8d9e06","NCT03412799","2019-10-03","Sun BioPharma","SNBP","Recruiting","Study of SBP-101 Combined With Nab-Paclitaxel and Gemcitabine in Pancreatic Cancer","Sbp-101|Paclitaxel|Gemcitabine","Tubulin Inhibitor|DNA Synthesis Inhibitor","Yes","['Sbp-101']","No",null,"Phase 1",null,24,"Anticipated","2018-06-04","2020-03-01",{"$nulls":5},"This is an open-label phase 1A/1B study to assess the safety, tolerability and pharmacokinetics of SBP-101 when combined with nab-paclitaxel and gemcitabine in subjects with previously untreated metastatic pancreatic ductal adenocarcinoma and to identify a recommended phase 2 dose. The study will also assess preliminary efficacy of the 3-drug treatment combination.","The study will be conducted in two phases: dose escalation and expansion. Up to three dose levels of SBP-101 will be assessed in up to 18 subjects during dose escalation. The expansion phase of the study will consist of 10 additional subjects who will receive the recommended dose of SBP-101 combined with nab-paclitaxel and gemcitabine.","Phase 1A/1B Dose Escalation and Expansion Study of SBP-101 in Combination With Nab-Paclitaxel and Gemcitabine in Subjects With Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma","CL-SBP-101-03","Pancreatic Cancer Metastatic\nPancreatic Cancer Stage IV\nStage IV Pancreatic Cancer","Pancreatic Cancer","Oncology Solid Tumor","Oncology",{"$nulls":3},"Drug","SBP-101|nab-paclitaxel|Gemcitabine Injection","Administered as subcutaneous (SC) injection, escalating dose cohorts|Administered as intravenous (IV) infusion","diethyl dihydroxyhomospermine | [(HO)2-DEHSPM]|abraxane | protein-bound paclitaxel|gemcitabine hydrochloride | Gemzar",null,"\n\n * Histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma. Patients with pancreatic acinar cell carcinoma may also be included.\n * Is previously untreated for metastatic pancreatic ductal adenocarcinoma, was diagnosed within the past 3 months, and is expected to receive standard treatment with gemcitabine and nab-paclitaxel.\n * Measurable disease on CT or MRI scan by RECIST v 1.1 criteria.\n * ECOG Performance Status 0 or 1.\n * Adult, age â‰¥ 18 years, male or female.\n * Females of child-bearing potential must have a negative serum pregnancy test within 14 days prior to start of study treatment and must use an adequate method of contraception during the study. All sexually active males must also use an adequate method of contraception during the study. Female subjects will be considered to be of childbearing potential unless they are postmenopausal (at least 12 months of consecutive amenorrhea, without other known or suspected cause) and over 55 years old or have been sterilized surgically (i.e., bilateral tubal ligation, hysterectomy or bilateral oophorectomy, all with surgery at least one month before dosing).\n * Adequate bone marrow, hepatic, renal and coagulation function as defined by the following: 1. Absolute neutrophil count â‰¥1.5 x 109/L\n    2. Hemoglobin â‰¥9.0 g/dL (90 g/L)\n    3. Platelets â‰¥100 x 109/L\n    4. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) â‰¤2.5 x upper limit of normal (ULN) (if no hepatic metastases). If hepatic tumor involvement, AST and ALT â‰¤5 x ULN.\n    5. Bilirubin â‰¤1.5 x ULN\n    6. Prothrombin time (PT) / international normalized ratio (INR) â‰¤1.5 x ULN if not on anti-coagulants\n    7. Calculated creatinine clearance >50 mL/min using the Cockcroft and Gault equation\n   \n   \n * QTc interval â‰¤ 470 msec at Baseline.\n * Life expectancy â‰¥ 3 months.\n * Willing and able to provide written informed consent: voluntary agreement to participate in the study following disclosure of risks and procedures required, including possibility of onset of exocrine pancreatic insufficiency with subsequent requirement for life-long pancreatic enzyme replacement.\n\n","\n\n * Evidence of severe or uncontrolled systemic disease or any concurrent condition that, in the opinion of the Investigator or Medical Monitor, makes it undesirable for the subject to participate in the study or that would jeopardize compliance with the protocol. Subjects with pre-existing well-controlled diabetes are not excluded.\n * Medical or psychiatric conditions that compromise the subject's ability to give informed consent or to complete the protocol or a history of non-compliance\n * Presence of islet-cell or pancreatic neuroendocrine tumor or mixed adenocarcinoma-neuroendocrine carcinoma\n * Have symptomatic central nervous system (CNS) malignancy or metastasis. Screening of asymptomatic subjects without history of CNS metastases is not required.\n * Serum albumin <30 g/L (3.0 g/dL)\n * Evidence of deep vein thrombosis or pulmonary embolism or other thromboembolic event during screening\n * Presence of known active bacterial, fungal, or viral infection requiring systemic therapy\n * Known active infection with human immunodeficiency virus (HIV), hepatitis B or C\n * Presence of interstitial lung disease, pulmonary fibrosis, or pulmonary hypersensitivity reaction\n * Myocardial infarction within the last 12 months, severe/unstable angina, symptomatic congestive heart failure New York Heart Association (NYHA) class III or IV\n * Maldigestion/malabsorption syndrome pre-dating the diagnosis of pancreatic cancer.\n * Pregnant or lactating\n * Major surgery within 4 weeks of the start of study treatment, without complete recovery\n * Known hypersensitivity to any component of study treatments\n * Participation in any other clinical investigation within 4 weeks of receiving the first dose of study drug\n * Subjects taking metformin. Diabetics on treatment with metformin, or any other derivative thereof, must discontinue it while on study. (Other diabetic medications are allowed.)",{"$nulls":4},"Actual","2018-01-26","Actual","Anticipated","2020-12-01","Anticipated","2019-09-01","2018-01-19","2018-01-25","2019-10-02","Yes",null,"Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":19},"Recommended dose of SBP-101","Up to 12 months following the first dose of treatment",null,"Number of subjects with adverse events as a measure of safety and tolerability|Tumor response will be evaluated on RECIST definitions|Area under the plasma concentration versus time curve (AUC) for all three drugs|Peak plasma concentration (Cmax) for all three drugs","Up to 24 months following the first dose of treatment|Every 8 weeks during treatment assessed up to 24 months|Day 1 of Cycle 1",null,"ssmith@couranteoncology.com","Sheri Smith","952-908-9986","Kurralta Park, South|Blacktown, New South Wales, Australia, 2148|Tugun, Queensland, Australia, 4224|Heidelberg, Victoria, Australia, 3084|Gainesville, Florida, United States, 32610|Rochester, New York, United States, 14642","Florida|New York","Australia|United States","Ashford Cancer Centre|New South Wales Blacktown Cancer & Haematology Centre|Queensland John Flynn Private Hospital|Victoria Austin Health|University Of Florida|University Of Rochester Medical Center","tgroene@sunbiopharma.com","Tammy Groene","952-479-1196","Suzanne Gagnon, MD","2019-10-02","2020-05-25T16:38:59.443","2020-05-26T17:10:42.972","NCT03412799"]
["5ecbf4a3e2561b1b11905e70","NCT03412890","2019-04-10","Myovant Sciences","MYOV","Enrolling by invitation","LIBERTY EXTENSION: Efficacy and Safety Extension Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids","Relugolix|Estradiol|Norethindrone acetate","GnRH Antagonist|ER Agonist|GnRH Agonist","Yes","['Relugolix']","No",null,"Phase 3",1,600,"Anticipated","2017-10-19","2020-02-28",{"$nulls":5},"The purpose of this study is to determine the long-term efficacy of Relugolix 40 mg once daily co-administered with low-dose estradiol and norethindrone acetate for up to 52 weeks, on heavy menstrual bleeding associated with uterine fibroids in patients who previously completed a 24-week treatment period in one of the parent studies (MVT-601-3001 or MVT-601-3002).","This study is an international phase 3 open-label, single-arm, long-term efficacy and safety extension study that will enroll eligible patients who have completed their participation in one of the phase 3 randomized, double-blind, placebo-controlled parent studies, MVT-601-3001 (LIBERTY 1 - NCT03049735) or MVT-601-3002 (LIBERTY 2 - NCT 03103087). All patients will receive relugolix 40 mg once daily co-administered with low-dose estradiol (1.0 mg) and norethindrone acetate (0.5 mg) for up to 28 weeks.\n\nApproximately 600 women with heavy menstrual bleeding associated with uterine fibroids will be enrolled, after having completed a 24-week treatment period in one of the parent studies. The objectives of the study are to evaluate long-term efficacy and safety through up to 52 weeks of treatment (including treatment during the parent study) of relugolix co-administered with low-dose estradiol/norethindrone acetate.\n\nScreening and baseline procedures will be done at the same visit for this extension study (referred to as the \"Week 24/Baseline Visit\"), which coincides with the Week 24 visit from the parent study, and will be defined as the date of completion of the last Week 24 procedure in the parent study. Patients will have received their last dose of study drug in the parent study on the day prior to the Week 24/Baseline Visit and will receive their first dose of study drug for this extension study in the clinic after the patient is determined to be eligible for this extension study and has provided informed consent to participate. The administration of the first dose of study drug for MVT-601-3003 will define enrollment into this study. Study participants will then take the open-label study treatment orally once daily for 28 weeks.","LIBERTY EXTENSION: An International Phase 3 Open-Label, Single-Arm, Long-Term Efficacy and Safety Extension Study to Evaluate Relugolix Co-Administered With Low-Dose Estradiol and Norethindrone Acetate in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids","MVT-601-3003","Heavy Menstrual Bleeding\nUterine Fibroid","Injuries/wounds Unspecified","General Injuries/wounds","Wounds & Injuries","Experimental","Relugolix plus E2/NETA","Relugolix 40 mg co-administered with estradiol (1.0 mg) and norethindrone acetate (0.5 mg) for up to 28 weeks","Drug","Relugolix|Estradiol/norethindrone acetate","Relugolix 40 mg tablet administered orally once daily|Capsule containing co-formulated tablet of estradiol 1.0 mg and norethindrone acetate 0.5 mg administered orally once daily","TAK-385|E2/NETA, low-dose hormonal add-back","Relugolix plus E2/NETA","\n\n1. Completed 24 weeks of study drug treatment and study participation in either MVTâ€‘601â€‘3001 or MVTâ€‘601â€‘3002\n\nKey ","\n\n 1. Has undergone myomectomy, ultrasound-guided laparoscopic radiofrequency ablation, or any other surgical procedure for fibroids, uterine artery embolization, magnetic resonance-guided focused ultrasound for fibroids, or endometrial ablation for abnormal uterine bleeding at any time during the parent study (MVTâ€‘601â€‘3001 or MVTâ€‘601â€‘3002)\n 2. Met a withdrawal criterion in the parent study (MVTâ€‘601â€‘3001 or MVTâ€‘601â€‘3002).",{"$nulls":4},"Actual","2018-01-29","Actual","Anticipated","2020-07-30","Anticipated","2019-04-01","2018-01-19","2018-01-19","2019-04-08","No",null,"Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","18 Years","50 Years","Female",null,"No","Undecided",{"$nulls":3},"Yes","No",{"$nulls":17},"2017-003310-74","EudraCT Number","Responder rate based on reduction in menstrual blood loss (MBL) volume","Defined as the proportion of women who achieve a MBL volume of < 80 mL and a â‰¥ 50% reduction from parent study Baseline MBL volume over the last 35 days of treatment. MBL volume is measured using the alkaline hematin method.","from Parent study Baseline up to last 35 days of treatment, anticipated to be up to 52 weeks","Time to MBL response|Change in MBL volume|Proportion of women with suppression of bleeding|Change in hemoglobin concentration|Change in uterine volume|Change in primary fibroid volume|Change in impact on quality of life|Bone Mineral Density (BMD)|The number and percentage of participants with adverse events (AE) as a measure of safety and tolerability|Serum estradiol concentrations","Defined as the time to achieve a MBL volume of < 80 mL and a â‰¥ 50% reduction from parent study Baseline MBL volume as measured by the alkaline hematin method.|MBL volume is measured using the alkaline hematin method.|Will be assessed using patient daily diary and MBL volume measured using the alkaline hematin method.|Blood samples will be collected from participants for hemoglobin measurements.|Volume of the uterus will be measured by transvaginal or transabdominal ultrasound.|Volume of the primary fibroid will be measured by transvaginal or transabdominal ultrasound.|Assessed using the Uterine Fibroid Symptom Health-Related Quality of Life Questionnaire (UFS-QOL).|Assessed by dual-energy X-ray absorptiometry (DXA) scan.|Assessed by frequency and severity of AEs and serious AEs.|Blood samples will be collected from participants for estradiol measurements.","up to 52 weeks|from parent study Baseline up to Week 52|from parent study Baseline up to last 35 days of treatment, anticipated to be up to 52 weeks",{"$nulls":3},"Jette, Belgium, 1090|Porto Alegre, Brazil, 90035-903 Porto AlegrePorto Alegre, Brazil, 90510-040|Santo AndrÃ©, Santo Andre, Brazil, 09190-510|SÃ£o Paulo, Sao Paulo, Brazil, 01317-000 Sao PauloSÃ£o Paulo, Sao Paulo, Brazil, 04266-010|Firenze, Italy, 50134 SienaSiena, Italy, 53100 TorinoTorino, Italy, 10126|Gdansk, Poland, 80-850|Bloemfontein, South Africa, 9301 Cape TownCape Town, South Africa, 7405 Cape TownCape Town, South Africa, 7500 Port ElizabethPort Elizabeth, South Africa, 6001|Mesa, Arizona, United States, 85209|Denver, Colorado, United States, 80209|Aventura, Florida, United States, 33180 MargateMargate, Florida, United States, 33063 PlantationPlantation, Florida, United States, 33324 TampaTampa, Florida, United States, 33613|Chicago, Illinois, United States, 60611|Shawnee Mission, Kansas, United States, 66218|Metairie, Louisiana, United States, 70001|Las Vegas, Nevada, United States, 89128|Albuquerque, New|Englewood, Ohio, United States, 45322|Philadelphia, Pennsylvania, United States, 19104|Beaumont, Texas, United States, 77702 DallasDallas, Texas, United States, 75231 FriscoFrisco, Texas, United States, 75035 HoustonHouston, Texas, United States, 77054 IrvingIrving, Texas, United States, 75062","Arizona|Colorado|Florida|Illinois|Kansas|Louisiana|Nevada|New Mexico|Ohio|Pennsylvania|Texas","Belgium|Brazil|Italy|Poland|South Africa|United States","Jette|Porto Alegre|Santo Andre Santo Andre|Sao Paulo Sao Paulo|Firenze|Gdansk|Bloemfontein|Mesa|Denver|Aventura|Chicago|Shawnee|Metairie|Las Vegas|Albuquerque|Englewood|Philadelphia|Beaumont",{"$nulls":3},"Myovant Medical Monitor, MD","2019-04-08","2020-05-25T16:38:59.638","2020-05-26T17:10:42.972","NCT03412890"]
["5ecbf4a4feab101b155309a6","NCT03412890","2019-05-20","Myovant Sciences","MYOV","Enrolling by invitation","LIBERTY EXTENSION: Efficacy and Safety Extension Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids","Relugolix|Estradiol|Norethindrone acetate","GnRH Antagonist|ER Agonist|GnRH Agonist","Yes","['Relugolix']","No",null,"Phase 3",1,600,"Anticipated","2017-10-19","2020-02-28",{"$nulls":5},"The purpose of this study is to determine the long-term efficacy of Relugolix 40 mg once daily co-administered with low-dose estradiol and norethindrone acetate for up to 52 weeks, on heavy menstrual bleeding associated with uterine fibroids in patients who previously completed a 24-week treatment period in one of the parent studies (MVT-601-3001 or MVT-601-3002).","This study is an international phase 3 open-label, single-arm, long-term efficacy and safety extension study that will enroll eligible patients who have completed their participation in one of the phase 3 randomized, double-blind, placebo-controlled parent studies, MVT-601-3001 (LIBERTY 1 - NCT03049735) or MVT-601-3002 (LIBERTY 2 - NCT 03103087). All patients will receive relugolix 40 mg once daily co-administered with low-dose estradiol (1.0 mg) and norethindrone acetate (0.5 mg) for up to 28 weeks.\n\nApproximately 600 women with heavy menstrual bleeding associated with uterine fibroids will be enrolled, after having completed a 24-week treatment period in one of the parent studies. The objectives of the study are to evaluate long-term efficacy and safety through up to 52 weeks of treatment (including treatment during the parent study) of relugolix co-administered with low-dose estradiol/norethindrone acetate.\n\nScreening and baseline procedures will be done at the same visit for this extension study (referred to as the \"Week 24/Baseline Visit\"), which coincides with the Week 24 visit from the parent study, and will be defined as the date of completion of the last Week 24 procedure in the parent study. Patients will have received their last dose of study drug in the parent study on the day prior to the Week 24/Baseline Visit and will receive their first dose of study drug for this extension study in the clinic after the patient is determined to be eligible for this extension study and has provided informed consent to participate. The administration of the first dose of study drug for MVT-601-3003 will define enrollment into this study. Study participants will then take the open-label study treatment orally once daily for 28 weeks.","LIBERTY EXTENSION: An International Phase 3 Open-Label, Single-Arm, Long-Term Efficacy and Safety Extension Study to Evaluate Relugolix Co-Administered With Low-Dose Estradiol and Norethindrone Acetate in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids","MVT-601-3003","Heavy Menstrual Bleeding\nUterine Fibroid","Injuries/wounds Unspecified","General Injuries/wounds","Wounds & Injuries","Experimental","Relugolix plus E2/NETA","Relugolix 40 mg co-administered with estradiol (1.0 mg) and norethindrone acetate (0.5 mg) for up to 28 weeks","Drug","Relugolix|Estradiol/norethindrone acetate","Relugolix 40 mg tablet administered orally once daily|Capsule containing co-formulated tablet of estradiol 1.0 mg and norethindrone acetate 0.5 mg administered orally once daily","TAK-385|E2/NETA, low-dose hormonal add-back","Relugolix plus E2/NETA","\n\n1. Completed 24 weeks of study drug treatment and study participation in either MVTâ€‘601â€‘3001 or MVTâ€‘601â€‘3002\n\nKey ","\n\n 1. Has undergone myomectomy, ultrasound-guided laparoscopic radiofrequency ablation, or any other surgical procedure for fibroids, uterine artery embolization, magnetic resonance-guided focused ultrasound for fibroids, or endometrial ablation for abnormal uterine bleeding at any time during the parent study (MVTâ€‘601â€‘3001 or MVTâ€‘601â€‘3002)\n 2. Met a withdrawal criterion in the parent study (MVTâ€‘601â€‘3001 or MVTâ€‘601â€‘3002).",{"$nulls":4},"Actual","2018-01-29","Actual","Anticipated","2020-07-30","Anticipated","2019-05-01","2018-01-19","2018-01-19","2019-05-16","No",null,"Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","18 Years","50 Years","Female",null,"No","Undecided",{"$nulls":3},"Yes","No",{"$nulls":17},"2017-003310-74","EudraCT Number","Responder rate based on reduction in menstrual blood loss (MBL) volume","Defined as the proportion of women who achieve a MBL volume of < 80 mL and a â‰¥ 50% reduction from parent study Baseline MBL volume over the last 35 days of treatment. MBL volume is measured using the alkaline hematin method.","from Parent study Baseline up to last 35 days of treatment, anticipated to be up to 52 weeks","Time to MBL response|Change in MBL volume|Proportion of women with suppression of bleeding|Change in hemoglobin concentration|Change in uterine volume|Change in primary fibroid volume|Change in impact on quality of life|Bone Mineral Density (BMD)|The number and percentage of participants with adverse events (AE) as a measure of safety and tolerability|Serum estradiol concentrations","Defined as the time to achieve a MBL volume of < 80 mL and a â‰¥ 50% reduction from parent study Baseline MBL volume as measured by the alkaline hematin method.|MBL volume is measured using the alkaline hematin method.|Will be assessed using patient daily diary and MBL volume measured using the alkaline hematin method.|Blood samples will be collected from participants for hemoglobin measurements.|Volume of the uterus will be measured by transvaginal or transabdominal ultrasound.|Volume of the primary fibroid will be measured by transvaginal or transabdominal ultrasound.|Assessed using the Uterine Fibroid Symptom Health-Related Quality of Life Questionnaire (UFS-QOL).|Assessed by dual-energy X-ray absorptiometry (DXA) scan.|Assessed by frequency and severity of AEs and serious AEs.|Blood samples will be collected from participants for estradiol measurements.","up to 52 weeks|from parent study Baseline up to Week 52|from parent study Baseline up to last 35 days of treatment, anticipated to be up to 52 weeks",{"$nulls":3},"Brussels, Belgium, 1200 JetteJette, Belgium, 1090|La LouviÃ¨re, Hainaut, Belgium, 7100|Gent, Oost-Vlaanderen, Belgium, 9000|Botucatu, Brazil, 18618-686 Porto AlegrePorto Alegre, Brazil, 90035-903 Porto AlegrePorto Alegre, Brazil, 90510-040|Santo AndrÃ©, Santo Andre, Brazil, 09190-510|Santo AndrÃ©, Sao Paulo, Brazil, 09190-510|SÃ£o Paulo, Sao Paulo, Brazil, 01317-000 Sao PauloSÃ£o Paulo, Sao Paulo, Brazil, 04266-010|Providencia, Chile, 7510186 San RamonSan RamÃ³n, Chile, 8880465 Region MetropolitanaSantiago, Chile, 8320165 SantiagoSantiago, Chile, 8360160|Jihlava, Czechia, 586 33 OlomoucOlomouc, Czechia, 772 00 PisekPÃ­sek, Czechia, 39701 CeskÃ© BudejoviceÄŒeskÃ© BudÄ›jovice, Czechia, 370 01|KecskemÃ©t, Bacs-Kiskun, Hungary, 6000|Gyula, Bekes, Hungary, 5700|Debrecen, Hungary, 4025 SzentesSzentes, Hungary, 6600|Debrecen, Hajdu-Bihar, Hungary, 4024|NyÃ­regyhÃ¡za, Szabolcs-Szatmar-Bereg, Hungary, 4400|Catanzaro, Italy, 88100 FirenzeFirenze, Italy, 50134 RomaRoma, Italy, 00168 SienaSiena, Italy, 53100 TorinoTorino, Italy, 10126|BiaÅ‚ystok, Poland, 15-464 GdanskGdansk, Poland, 80-850|LÃ³dz, Lodzkie, Poland, 90-602|Lublin, Lubelskie, Poland, 20-632|Warszawa, Mazowieckie, Poland, 02-201|BiaÅ‚ystok, Podlaskie, Poland, 15224|Katowice, Slaskie, Poland, 40-123|PoznaÅ„, Wielkopolskie, Poland, 60-192|Szczecin, Zachodniopomorskie, Poland, 71-270|Centurion, Gauteng, South Africa, 0157 RoodepoortRoodepoort, Gauteng, South Africa, 1724|Durban, Kwazulu-Natal, South Africa, 4126|Bloemfontein, South Africa, 9301 Cape TownCape Town, South Africa, 7405 Cape TownCape Town, South Africa, 7500 Port ElizabethPort Elizabeth, South Africa, 6001|Andalusia, Alabama, United States, 36420 BirminghamBirmingham, Alabama, United States, 35205 MobileMobile, Alabama, United States, 36608|Mesa, Arizona, United States, 85209 TucsonTucson, Arizona, United States, 85712|Little Rock, Arkansas, United States, 72205|Canoga Park, California, United States, 91303 Huntington BeachHuntington Beach, California, United States, 92647 La MesaLa Mesa, California, United States, 91942 Long BeachLong Beach, California, United States, 90806 Los AngelesLos Angeles, California, United States, 90036 Los AngelesLos Angeles, California, United States, 90057 NorwalkNorwalk, California, United States, 90650 PanoramaPanorama City, California, United States, 91402 San DiegoSan Diego, California, United States, 92108 San DiegoSan Diego, California, United States, 92111|Denver, Colorado, United States, 80209 LakewoodLakewood, Colorado, United States, 80228 United States, District Of Columbia WashingtonWashington, District Of Columbia, United States, 20036|Aventura, Florida, United States, 33180 ClearwaterClearwater, Florida, United States, 33759 DelandDeland, Florida, United States, 32720 Ft. LauderdaleFort Lauderdale, Florida, United States, 33316 Fort MyersFort Myers, Florida, United States, 33912 HialeahHialeah, Florida, United States, 33016 JacksonvilleJacksonville, Florida, United States, 32207 JupiterJupiter, Florida, United States, 33458 LoxahacheeLoxahatchee Groves, Florida, United States, 33470 MargateMargate, Florida, United States, 33063 MiamiMiami, Florida, United States, 33126 MiamiMiami, Florida, United States, 33155 MiamiMiami, Florida, United States, 33165 New Port RicheyNew Port Richey, Florida, United States, 34652 OrlandoOrlando, Florida, United States, 32808 OviedoOviedo, Florida, United States, 32765 Palm HarborPalm Harbor, Florida, United States, 34684 PlantationPlantation, Florida, United States, 33324 Saint CloudSaint Cloud, Florida, United States, 34769 SarasotaSarasota, Florida, United States, 34239 TampaTampa, Florida, United States, 33606 TampaTampa, Florida, United States, 33613 West Palm BeachWest Palm Beach, Florida, United States, 33409 WestonWeston, Florida, United States, 33327|Atlanta, Georgia, United States, 30342 AtlantaAtlanta, Georgia, United States, 30363 AugustaAugusta, Georgia, United States, 30912 College ParkCollege Park, Georgia, United States, 30349 DecaturDecatur, Georgia, United States, 30034 DuluthDuluth, Georgia, United States, 30097 NorcrossNorcross, Georgia, United States, 30093 SavannahSavannah, Georgia, United States, 31406|Idaho Falls, Idaho, United States, 83404|Chicago, Illinois, United States, 60611 NapervilleNaperville, Illinois, United States, 60540 OakbrookOakbrook Terrace, Illinois, United States, 60523|Shawnee Mission, Kansas, United States, 66218|Covington, Louisiana, United States, 70433 MarreroMarrero, Louisiana, United States, 70072 MetairieMetairie, Louisiana, United States, 70001 MetairieMetairie, Louisiana, United States, 70006|Baltimore, Maryland, United States, 21208 TowsonTowson, Maryland, United States, 21204|Canton, Michigan, United States, 48187 DetroitDetroit, Michigan, United States, 48201 SaginawSaginaw, Michigan, United States, 48604|Lincoln, Nebraska, United States, 68510 OmahaOmaha, Nebraska, United States, 68124|Las Vegas, Nevada, United States, 89106 Las VegasLas Vegas, Nevada, United States, 89109 Las VegasLas Vegas, Nevada, United States, 89113 Las VegasLas Vegas, Nevada, United States, 89128|Lawrenceville, New Jersey, United States, 08648|Albuquerque, New|Brooklyn, New York, United States, 11201 New YorkNew York, New York, United States, 10022 WilliamsvilleWilliamsville, New York, United States, 14221|Durham, North Carolina, United States, 27713 RaleighRaleigh, North Carolina, United States, 27607 RaleighRaleigh, North Carolina, United States, 27612 Winston-SalemWinston-Salem, North Carolina, United States, 27103|Cincinnati, Ohio, United States, 45212 CincinnatiCincinnati, Ohio, United States, 45219 ColumbusColumbus, Ohio, United States, 43231 EnglewoodEnglewood, Ohio, United States, 45322|Philadelphia, Pennsylvania, United States, 19104|Bluffton, South Carolina, United States, 29910 CharlestonCharleston, South Carolina, United States, 29406 ColumbiaColumbia, South Carolina, United States, 29201|Chattanooga, Tennessee, United States, 37404 MemphisMemphis, Tennessee, United States, 38119 MemphisMemphis, Tennessee, United States, 38120|Beaumont, Texas, United States, 77702 DallasDallas, Texas, United States, 75231 Fort WorthFort Worth, Texas, United States, 76104 FriscoFrisco, Texas, United States, 75035 HoustonHouston, Texas, United States, 77030 HoustonHouston, Texas, United States, 77054 HoustonHouston, Texas, United States, 77074 IrvingIrving, Texas, United States, 75062 LongviewLongview, Texas, United States, 75605 San AntonioSan Antonio, Texas, United States, 78229 San AntonioSan Antonio, Texas, United States, 78258 Sugar LandSugar Land, Texas, United States, 77479 WebsterWebster, Texas, United States, 77598|Salt Lake City, Utah, United States, 84107 Salt Lake CitySalt Lake City, Utah, United States, 84124|Norfolk, Virginia, United States, 23502 NorfolkNorfolk, Virginia, United States, 23507 RichmondRichmond, Virginia, United States, 23225|Seattle, Washington, United States, 98105 SpokaneSpokane, Washington, United States, 99207","Alabama|Arizona|Arkansas|California|Colorado|Florida|Georgia|Idaho|Illinois|Kansas|Louisiana|Maryland|Michigan|Nebraska|Nevada|New Jersey|New Mexico|New York|North Carolina|Ohio|Pennsylvania|South Carolina|Tennessee|Texas|Utah|Virginia|Washington","Belgium|Brazil|Chile|Czechia|Hungary|Italy|Poland|South Africa|United States","Brussels|Hainaut La LouviÃ¨re|Oost-Vlaanderen Gent|Botucatu|Santo Andre Santo Andre|Sao Paulo Santo AndrÃ©|Sao Paulo Sao Paulo|Providencia|Jihlava|Bacs-Kiskun KecskemÃ©t|Bekes Gyula|Debrecen|Hajdu-Bihar Debrecen|Szabolcs-Szatmar-Bereg NyÃ­regyhÃ¡za|Catanzaro|Bialystok|Lodzkie LÃ³dz|Lubelskie Lublin|Mazowieckie Warszawa|Podlaskie BiaÅ‚ystok|Slaskie Katowice|Wielkopolskie Poznan|Zachodniopomorskie Szczecin|, Gauteng Centurion|, Kwazulu-Natal Durban|Bloemfontein|Andaluisa|Mesa|Little Rock|Canoga Park|Denver|Aventura|Atlanta|Idaho Falls|Chicago|Shawnee|Covington|Baltimore|Canton|Lincoln|Las Vegas|Lawrenceville|Albuquerque|Brooklyn|Durham|Cincinnati|Philadelphia|Bluffton|Chattanooga|Beaumont|Salt Lake City|Norfolk|Seattle",{"$nulls":3},"Myovant Medical Monitor, MD","2019-05-16","2020-05-25T16:39:00.204","2020-05-26T17:10:42.972","NCT03412890"]
["5ecbf4a4307e3d1b1f8d9e08","NCT03412890","2019-09-10","Myovant Sciences","MYOV","Active, not recruiting","LIBERTY EXTENSION: Efficacy and Safety Extension Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids","Relugolix|Estradiol|Norethindrone acetate","GnRH Antagonist|ER Agonist|GnRH Agonist","Yes","['Relugolix']","No",null,"Phase 3",1,600,"Actual","2017-10-19","2020-02-28",{"$nulls":5},"The purpose of this study is to determine the long-term efficacy of Relugolix 40 mg once daily co-administered with low-dose estradiol and norethindrone acetate for up to 52 weeks, on heavy menstrual bleeding associated with uterine fibroids in patients who previously completed a 24-week treatment period in one of the parent studies (MVT-601-3001 or MVT-601-3002).","This study is an international phase 3 open-label, single-arm, long-term efficacy and safety extension study that will enroll eligible patients who have completed their participation in one of the phase 3 randomized, double-blind, placebo-controlled parent studies, MVT-601-3001 (LIBERTY 1 - NCT03049735) or MVT-601-3002 (LIBERTY 2 - NCT 03103087). All patients will receive relugolix 40 mg once daily co-administered with low-dose estradiol (1.0 mg) and norethindrone acetate (0.5 mg) for up to 28 weeks.\n\nApproximately 600 women with heavy menstrual bleeding associated with uterine fibroids will be enrolled, after having completed a 24-week treatment period in one of the parent studies. The objectives of the study are to evaluate long-term efficacy and safety through up to 52 weeks of treatment (including treatment during the parent study) of relugolix co-administered with low-dose estradiol/norethindrone acetate.\n\nScreening and baseline procedures will be done at the same visit for this extension study (referred to as the \"Week 24/Baseline Visit\"), which coincides with the Week 24 visit from the parent study, and will be defined as the date of completion of the last Week 24 procedure in the parent study. Patients will have received their last dose of study drug in the parent study on the day prior to the Week 24/Baseline Visit and will receive their first dose of study drug for this extension study in the clinic after the patient is determined to be eligible for this extension study and has provided informed consent to participate. The administration of the first dose of study drug for MVT-601-3003 will define enrollment into this study. Study participants will then take the open-label study treatment orally once daily for 28 weeks.","LIBERTY EXTENSION: An International Phase 3 Open-Label, Single-Arm, Long-Term Efficacy and Safety Extension Study to Evaluate Relugolix Co-Administered With Low-Dose Estradiol and Norethindrone Acetate in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids","MVT-601-3003","Heavy Menstrual Bleeding\nUterine Fibroid","Injuries/wounds Unspecified","General Injuries/wounds","Wounds & Injuries","Experimental","Relugolix plus E2/NETA","Relugolix 40 mg co-administered with estradiol (1.0 mg) and norethindrone acetate (0.5 mg) for up to 28 weeks","Drug","Relugolix|Estradiol/norethindrone acetate","Relugolix 40 mg tablet administered orally once daily|Capsule containing co-formulated tablet of estradiol 1.0 mg and norethindrone acetate 0.5 mg administered orally once daily","TAK-385|E2/NETA, low-dose hormonal add-back","Relugolix plus E2/NETA","\n\n1. Completed 24 weeks of study drug treatment and study participation in either MVTâ€‘601â€‘3001 or MVTâ€‘601â€‘3002\n\nKey ","\n\n 1. Has undergone myomectomy, ultrasound-guided laparoscopic radiofrequency ablation, or any other surgical procedure for fibroids, uterine artery embolization, magnetic resonance-guided focused ultrasound for fibroids, or endometrial ablation for abnormal uterine bleeding at any time during the parent study (MVTâ€‘601â€‘3001 or MVTâ€‘601â€‘3002)\n 2. Met a withdrawal criterion in the parent study (MVTâ€‘601â€‘3001 or MVTâ€‘601â€‘3002).",{"$nulls":4},"Actual","2018-01-29","Actual","Anticipated","2020-07-30","Anticipated","2019-09-01","2018-01-19","2018-01-19","2019-09-06","No",null,"Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","18 Years","50 Years","Female",null,"No","Undecided",{"$nulls":3},"Yes","No",{"$nulls":17},"2017-003310-74","EudraCT Number","Responder rate based on reduction in menstrual blood loss (MBL) volume","Defined as the proportion of women who achieve a MBL volume of < 80 mL and a â‰¥ 50% reduction from parent study Baseline MBL volume over the last 35 days of treatment. MBL volume is measured using the alkaline hematin method.","from Parent study Baseline up to last 35 days of treatment, anticipated to be up to 52 weeks","Time to MBL response|Change in MBL volume|Proportion of women with suppression of bleeding|Change in hemoglobin concentration|Change in uterine volume|Change in primary fibroid volume|Change in impact on quality of life|Bone Mineral Density (BMD)|The number and percentage of participants with adverse events (AE) as a measure of safety and tolerability|Serum estradiol concentrations","Defined as the time to achieve a MBL volume of < 80 mL and a â‰¥ 50% reduction from parent study Baseline MBL volume as measured by the alkaline hematin method.|MBL volume is measured using the alkaline hematin method.|Will be assessed using patient daily diary and MBL volume measured using the alkaline hematin method.|Blood samples will be collected from participants for hemoglobin measurements.|Volume of the uterus will be measured by transvaginal or transabdominal ultrasound.|Volume of the primary fibroid will be measured by transvaginal or transabdominal ultrasound.|Assessed using the Uterine Fibroid Symptom Health-Related Quality of Life Questionnaire (UFS-QOL).|Assessed by dual-energy X-ray absorptiometry (DXA) scan.|Assessed by frequency and severity of AEs and serious AEs.|Blood samples will be collected from participants for estradiol measurements.","up to 52 weeks|from parent study Baseline up to Week 52|from parent study Baseline up to last 35 days of treatment, anticipated to be up to 52 weeks",{"$nulls":3},"Brussels, Belgium, 1200 JetteJette, Belgium, 1090|La LouviÃ¨re, Hainaut, Belgium, 7100|Gent, Oost-Vlaanderen, Belgium, 9000|Botucatu, Brazil, 18618-686 Porto AlegrePorto Alegre, Brazil, 90035-903 Porto AlegrePorto Alegre, Brazil, 90510-040|Santo AndrÃ©, Santo Andre, Brazil, 09190-510|Santo AndrÃ©, Sao Paulo, Brazil, 09190-510|SÃ£o Paulo, Sao Paulo, Brazil, 01317-000 Sao PauloSÃ£o Paulo, Sao Paulo, Brazil, 04266-010|Providencia, Chile, 7510186 San RamonSan RamÃ³n, Chile, 8880465 Region MetropolitanaSantiago, Chile, 8320165 SantiagoSantiago, Chile, 8360160|Jihlava, Czechia, 586 33 OlomoucOlomouc, Czechia, 772 00 PisekPÃ­sek, Czechia, 39701 CeskÃ© BudejoviceÄŒeskÃ© BudÄ›jovice, Czechia, 370 01|KecskemÃ©t, Bacs-Kiskun, Hungary, 6000|Gyula, Bekes, Hungary, 5700|Debrecen, Hungary, 4025 SzentesSzentes, Hungary, 6600|Debrecen, Hajdu-Bihar, Hungary, 4024|NyÃ­regyhÃ¡za, Szabolcs-Szatmar-Bereg, Hungary, 4400|Catanzaro, Italy, 88100 FirenzeFirenze, Italy, 50134 RomaRoma, Italy, 00168 SienaSiena, Italy, 53100 TorinoTorino, Italy, 10126|BiaÅ‚ystok, Poland, 15-464|LÃ³dz, Lodzkie, Poland, 90-602|Lublin, Lubelskie, Poland, 20-632|Warszawa, Mazowieckie, Poland, 02-201|Katowice, Slaskie, Poland, 40-123|PoznaÅ„, Wielkopolskie, Poland, 60-192|Szczecin, Zachodniopomorskie, Poland, 71-270|Centurion, Gauteng, South Africa, 0157 RoodepoortRoodepoort, Gauteng, South Africa, 1724|Durban, Kwazulu-Natal, South Africa, 4126|Bloemfontein, South Africa, 9301 Cape TownCape Town, South Africa, 7405 Cape TownCape Town, South Africa, 7500 Port ElizabethPort Elizabeth, South Africa, 6001|Andalusia, Alabama, United States, 36420 BirminghamBirmingham, Alabama, United States, 35205 MobileMobile, Alabama, United States, 36608|Mesa, Arizona, United States, 85209 TucsonTucson, Arizona, United States, 85712|Little Rock, Arkansas, United States, 72205|Canoga Park, California, United States, 91303 Huntington BeachHuntington Beach, California, United States, 92647 La MesaLa Mesa, California, United States, 91942 Long BeachLong Beach, California, United States, 90806 Los AngelesLos Angeles, California, United States, 90036 Los AngelesLos Angeles, California, United States, 90057 NorwalkNorwalk, California, United States, 90650 PanoramaPanorama City, California, United States, 91402 San DiegoSan Diego, California, United States, 92108 San DiegoSan Diego, California, United States, 92111|Denver, Colorado, United States, 80209 LakewoodLakewood, Colorado, United States, 80228 United States, District Of Columbia WashingtonWashington, District Of Columbia, United States, 20036|Aventura, Florida, United States, 33180 ClearwaterClearwater, Florida, United States, 33759 DelandDeland, Florida, United States, 32720 Ft. LauderdaleFort Lauderdale, Florida, United States, 33316 Fort MyersFort Myers, Florida, United States, 33912 HialeahHialeah, Florida, United States, 33016 JacksonvilleJacksonville, Florida, United States, 32207 JupiterJupiter, Florida, United States, 33458 LoxahacheeLoxahatchee Groves, Florida, United States, 33470 MargateMargate, Florida, United States, 33063 MiamiMiami, Florida, United States, 33126 MiamiMiami, Florida, United States, 33155 MiamiMiami, Florida, United States, 33165 New Port RicheyNew Port Richey, Florida, United States, 34652 OrlandoOrlando, Florida, United States, 32808 OviedoOviedo, Florida, United States, 32765 Palm HarborPalm Harbor, Florida, United States, 34684 PlantationPlantation, Florida, United States, 33324 Saint CloudSaint Cloud, Florida, United States, 34769 SarasotaSarasota, Florida, United States, 34239 TampaTampa, Florida, United States, 33606 TampaTampa, Florida, United States, 33613 West Palm BeachWest Palm Beach, Florida, United States, 33409 WestonWeston, Florida, United States, 33327|Atlanta, Georgia, United States, 30342 AtlantaAtlanta, Georgia, United States, 30363 AugustaAugusta, Georgia, United States, 30912 College ParkCollege Park, Georgia, United States, 30349 DecaturDecatur, Georgia, United States, 30034 DuluthDuluth, Georgia, United States, 30097 NorcrossNorcross, Georgia, United States, 30093 SavannahSavannah, Georgia, United States, 31406|Idaho Falls, Idaho, United States, 83404|Chicago, Illinois, United States, 60611 NapervilleNaperville, Illinois, United States, 60540 OakbrookOakbrook Terrace, Illinois, United States, 60523|Shawnee Mission, Kansas, United States, 66218|Covington, Louisiana, United States, 70433 MarreroMarrero, Louisiana, United States, 70072 MetairieMetairie, Louisiana, United States, 70001 MetairieMetairie, Louisiana, United States, 70006|Baltimore, Maryland, United States, 21208 TowsonTowson, Maryland, United States, 21204|Canton, Michigan, United States, 48187 DetroitDetroit, Michigan, United States, 48201 SaginawSaginaw, Michigan, United States, 48604|Lincoln, Nebraska, United States, 68510 OmahaOmaha, Nebraska, United States, 68124|Las Vegas, Nevada, United States, 89106 Las VegasLas Vegas, Nevada, United States, 89109 Las VegasLas Vegas, Nevada, United States, 89113 Las VegasLas Vegas, Nevada, United States, 89128|Lawrenceville, New Jersey, United States, 08648|Albuquerque, New|Brooklyn, New York, United States, 11201 New YorkNew York, New York, United States, 10022 WilliamsvilleWilliamsville, New York, United States, 14221|Durham, North Carolina, United States, 27713 RaleighRaleigh, North Carolina, United States, 27607 RaleighRaleigh, North Carolina, United States, 27612 Winston-SalemWinston-Salem, North Carolina, United States, 27103|Cincinnati, Ohio, United States, 45212 CincinnatiCincinnati, Ohio, United States, 45219 ColumbusColumbus, Ohio, United States, 43231 EnglewoodEnglewood, Ohio, United States, 45322|Philadelphia, Pennsylvania, United States, 19104|Bluffton, South Carolina, United States, 29910 CharlestonCharleston, South Carolina, United States, 29406 ColumbiaColumbia, South Carolina, United States, 29201|Chattanooga, Tennessee, United States, 37404 MemphisMemphis, Tennessee, United States, 38119 MemphisMemphis, Tennessee, United States, 38120|Beaumont, Texas, United States, 77702 DallasDallas, Texas, United States, 75231 Fort WorthFort Worth, Texas, United States, 76104 FriscoFrisco, Texas, United States, 75035 HoustonHouston, Texas, United States, 77030 HoustonHouston, Texas, United States, 77054 HoustonHouston, Texas, United States, 77074 IrvingIrving, Texas, United States, 75062 LongviewLongview, Texas, United States, 75605 San AntonioSan Antonio, Texas, United States, 78229 San AntonioSan Antonio, Texas, United States, 78258 Sugar LandSugar Land, Texas, United States, 77479 WebsterWebster, Texas, United States, 77598|Salt Lake City, Utah, United States, 84107 Salt Lake CitySalt Lake City, Utah, United States, 84124|Norfolk, Virginia, United States, 23502 NorfolkNorfolk, Virginia, United States, 23507 RichmondRichmond, Virginia, United States, 23225|Seattle, Washington, United States, 98105 SpokaneSpokane, Washington, United States, 99207","Alabama|Arizona|Arkansas|California|Colorado|Florida|Georgia|Idaho|Illinois|Kansas|Louisiana|Maryland|Michigan|Nebraska|Nevada|New Jersey|New Mexico|New York|North Carolina|Ohio|Pennsylvania|South Carolina|Tennessee|Texas|Utah|Virginia|Washington","Belgium|Brazil|Chile|Czechia|Hungary|Italy|Poland|South Africa|United States","Brussels|Hainaut La LouviÃ¨re|Oost-Vlaanderen Gent|Botucatu|Santo Andre Santo Andre|Sao Paulo Santo AndrÃ©|Sao Paulo Sao Paulo|Providencia|Jihlava|Bacs-Kiskun KecskemÃ©t|Bekes Gyula|Debrecen|Hajdu-Bihar Debrecen|Szabolcs-Szatmar-Bereg NyÃ­regyhÃ¡za|Catanzaro|Bialystok|Lodzkie LÃ³dz|Lubelskie Lublin|Mazowieckie Warszawa|Slaskie Katowice|Wielkopolskie Poznan|Zachodniopomorskie Szczecin|, Gauteng Centurion|, Kwazulu-Natal Durban|Bloemfontein|Andaluisa|Mesa|Little Rock|Canoga Park|Denver|Aventura|Atlanta|Idaho Falls|Chicago|Shawnee|Covington|Baltimore|Canton|Lincoln|Las Vegas|Lawrenceville|Albuquerque|Brooklyn|Durham|Cincinnati|Philadelphia|Bluffton|Chattanooga|Beaumont|Salt Lake City|Norfolk|Seattle",{"$nulls":3},"Myovant Medical Monitor, MD","2019-09-06","2020-05-25T16:39:00.380","2020-05-26T17:10:42.972","NCT03412890"]
["5ecbf4a4fe30261b1a048378","NCT03412890","2020-02-13","Myovant Sciences","MYOV","Active, not recruiting","LIBERTY EXTENSION: Efficacy and Safety Extension Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids","Relugolix|Estradiol|Norethindrone acetate","GnRH Antagonist|ER Agonist|GnRH Agonist","Yes","['Relugolix']","No",null,"Phase 3",1,477,"Actual","2017-10-19","2020-01-03",{"$nulls":5},"The purpose of this study is to determine the long-term efficacy of Relugolix 40 mg once daily co-administered with low-dose estradiol and norethindrone acetate for up to 52 weeks, on heavy menstrual bleeding associated with uterine fibroids in patients who previously completed a 24-week treatment period in one of the parent studies (MVT-601-3001 or MVT-601-3002).","This study is an international phase 3 open-label, single-arm, long-term efficacy and safety extension study that will enroll eligible patients who have completed their participation in one of the phase 3 randomized, double-blind, placebo-controlled parent studies, MVT-601-3001 (LIBERTY 1 - NCT03049735) or MVT-601-3002 (LIBERTY 2 - NCT 03103087). All patients will receive relugolix 40 mg once daily co-administered with low-dose estradiol (1.0 mg) and norethindrone acetate (0.5 mg) for up to 28 weeks.\n\nApproximately 600 women with heavy menstrual bleeding associated with uterine fibroids will be enrolled, after having completed a 24-week treatment period in one of the parent studies. The objectives of the study are to evaluate long-term efficacy and safety through up to 52 weeks of treatment (including treatment during the parent study) of relugolix co-administered with low-dose estradiol/norethindrone acetate.\n\nScreening and baseline procedures will be done at the same visit for this extension study (referred to as the \"Week 24/Baseline Visit\"), which coincides with the Week 24 visit from the parent study, and will be defined as the date of completion of the last Week 24 procedure in the parent study. Patients will have received their last dose of study drug in the parent study on the day prior to the Week 24/Baseline Visit and will receive their first dose of study drug for this extension study in the clinic after the patient is determined to be eligible for this extension study and has provided informed consent to participate. The administration of the first dose of study drug for MVT-601-3003 will define enrollment into this study. Study participants will then take the open-label study treatment orally once daily for 28 weeks.","LIBERTY EXTENSION: An International Phase 3 Open-Label, Single-Arm, Long-Term Efficacy and Safety Extension Study to Evaluate Relugolix Co-Administered With Low-Dose Estradiol and Norethindrone Acetate in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids","MVT-601-3003","Heavy Menstrual Bleeding\nUterine Fibroid","Injuries/wounds Unspecified","General Injuries/wounds","Wounds & Injuries","Experimental","Relugolix plus E2/NETA","Relugolix 40 mg co-administered with estradiol (1.0 mg) and norethindrone acetate (0.5 mg) for up to 28 weeks","Drug","Relugolix|Estradiol/norethindrone acetate","Relugolix 40 mg tablet administered orally once daily|Capsule containing co-formulated tablet of estradiol 1.0 mg and norethindrone acetate 0.5 mg administered orally once daily","TAK-385|E2/NETA, low-dose hormonal add-back","Relugolix plus E2/NETA","\n\n1. Completed 24 weeks of study drug treatment and study participation in either MVTâ€‘601â€‘3001 or MVTâ€‘601â€‘3002\n\nKey ","\n\n 1. Has undergone myomectomy, ultrasound-guided laparoscopic radiofrequency ablation, or any other surgical procedure for fibroids, uterine artery embolization, magnetic resonance-guided focused ultrasound for fibroids, or endometrial ablation for abnormal uterine bleeding at any time during the parent study (MVTâ€‘601â€‘3001 or MVTâ€‘601â€‘3002)\n 2. Met a withdrawal criterion in the parent study (MVTâ€‘601â€‘3001 or MVTâ€‘601â€‘3002).",{"$nulls":4},"Actual","2018-01-29","Actual","Actual","2020-07-30","Anticipated","2020-01-01","2018-01-19","2018-01-19","2020-02-12","No",null,"Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","18 Years","50 Years","Female",null,"No","Undecided",{"$nulls":3},"Yes","No",{"$nulls":17},"2017-003310-74","EudraCT Number","Responder rate based on reduction in menstrual blood loss (MBL) volume","Defined as the proportion of women who achieve a MBL volume of < 80 mL and a â‰¥ 50% reduction from parent study Baseline MBL volume over the last 35 days of treatment. MBL volume is measured using the alkaline hematin method.","from Parent study Baseline up to last 35 days of treatment, anticipated to be up to 52 weeks","Time to MBL response|Change in MBL volume|Proportion of women with suppression of bleeding|Change in hemoglobin concentration|Change in uterine volume|Change in primary fibroid volume|Change in impact on quality of life|Bone Mineral Density (BMD)|The number and percentage of participants with adverse events (AE) as a measure of safety and tolerability|Serum estradiol concentrations","Defined as the time to achieve a MBL volume of < 80 mL and a â‰¥ 50% reduction from parent study Baseline MBL volume as measured by the alkaline hematin method.|MBL volume is measured using the alkaline hematin method.|Will be assessed using patient daily diary and MBL volume measured using the alkaline hematin method.|Blood samples will be collected from participants for hemoglobin measurements.|Volume of the uterus will be measured by transvaginal or transabdominal ultrasound.|Volume of the primary fibroid will be measured by transvaginal or transabdominal ultrasound.|Assessed using the Uterine Fibroid Symptom Health-Related Quality of Life Questionnaire (UFS-QOL).|Assessed by dual-energy X-ray absorptiometry (DXA) scan.|Assessed by frequency and severity of AEs and serious AEs.|Blood samples will be collected from participants for estradiol measurements.","up to 52 weeks|from parent study Baseline up to Week 52|from parent study Baseline up to last 35 days of treatment, anticipated to be up to 52 weeks",{"$nulls":3},"Brussels, Belgium, 1200 JetteJette, Belgium, 1090|La LouviÃ¨re, Hainaut, Belgium, 7100|Gent, Oost-Vlaanderen, Belgium, 9000|Botucatu, Brazil, 18618-686 Porto AlegrePorto Alegre, Brazil, 90035-903 Porto AlegrePorto Alegre, Brazil, 90510-040|Santo AndrÃ©, Santo Andre, Brazil, 09190-510|Santo AndrÃ©, Sao Paulo, Brazil, 09190-510|SÃ£o Paulo, Sao Paulo, Brazil, 01317-000 Sao PauloSÃ£o Paulo, Sao Paulo, Brazil, 04266-010|Providencia, Chile, 7510186 San RamonSan RamÃ³n, Chile, 8880465 Region MetropolitanaSantiago, Chile, 8320165 SantiagoSantiago, Chile, 8360160|Jihlava, Czechia, 586 33 OlomoucOlomouc, Czechia, 772 00 PisekPÃ­sek, Czechia, 39701 CeskÃ© BudejoviceÄŒeskÃ© BudÄ›jovice, Czechia, 370 01|KecskemÃ©t, Bacs-Kiskun, Hungary, 6000|Gyula, Bekes, Hungary, 5700|Debrecen, Hungary, 4025 SzentesSzentes, Hungary, 6600|Debrecen, Hajdu-Bihar, Hungary, 4024|NyÃ­regyhÃ¡za, Szabolcs-Szatmar-Bereg, Hungary, 4400|Catanzaro, Italy, 88100 FirenzeFirenze, Italy, 50134 RomaRoma, Italy, 00168 SienaSiena, Italy, 53100 TorinoTorino, Italy, 10126|BiaÅ‚ystok, Poland, 15-464|LÃ³dz, Lodzkie, Poland, 90-602|Lublin, Lubelskie, Poland, 20-632|Warszawa, Mazowieckie, Poland, 02-201|Katowice, Slaskie, Poland, 40-123|PoznaÅ„, Wielkopolskie, Poland, 60-192|Szczecin, Zachodniopomorskie, Poland, 71-270|Centurion, Gauteng, South Africa, 0157 RoodepoortRoodepoort, Gauteng, South Africa, 1724|Durban, Kwazulu-Natal, South Africa, 4126|Bloemfontein, South Africa, 9301 Cape TownCape Town, South Africa, 7405 Cape TownCape Town, South Africa, 7500 Port ElizabethPort Elizabeth, South Africa, 6001|Andalusia, Alabama, United States, 36420 BirminghamBirmingham, Alabama, United States, 35205 MobileMobile, Alabama, United States, 36608|Mesa, Arizona, United States, 85209 TucsonTucson, Arizona, United States, 85712|Little Rock, Arkansas, United States, 72205|Canoga Park, California, United States, 91303 Huntington BeachHuntington Beach, California, United States, 92647 La MesaLa Mesa, California, United States, 91942 Long BeachLong Beach, California, United States, 90806 Los AngelesLos Angeles, California, United States, 90036 Los AngelesLos Angeles, California, United States, 90057 NorwalkNorwalk, California, United States, 90650 PanoramaPanorama City, California, United States, 91402 San DiegoSan Diego, California, United States, 92108 San DiegoSan Diego, California, United States, 92111|Denver, Colorado, United States, 80209 LakewoodLakewood, Colorado, United States, 80228 United States, District Of Columbia WashingtonWashington, District Of Columbia, United States, 20036|Aventura, Florida, United States, 33180 ClearwaterClearwater, Florida, United States, 33759 DelandDeland, Florida, United States, 32720 Ft. LauderdaleFort Lauderdale, Florida, United States, 33316 Fort MyersFort Myers, Florida, United States, 33912 HialeahHialeah, Florida, United States, 33016 JacksonvilleJacksonville, Florida, United States, 32207 JupiterJupiter, Florida, United States, 33458 LoxahacheeLoxahatchee Groves, Florida, United States, 33470 MargateMargate, Florida, United States, 33063 MiamiMiami, Florida, United States, 33126 MiamiMiami, Florida, United States, 33155 MiamiMiami, Florida, United States, 33165 New Port RicheyNew Port Richey, Florida, United States, 34652 OrlandoOrlando, Florida, United States, 32808 OviedoOviedo, Florida, United States, 32765 Palm HarborPalm Harbor, Florida, United States, 34684 PlantationPlantation, Florida, United States, 33324 Saint CloudSaint Cloud, Florida, United States, 34769 SarasotaSarasota, Florida, United States, 34239 TampaTampa, Florida, United States, 33606 TampaTampa, Florida, United States, 33613 West Palm BeachWest Palm Beach, Florida, United States, 33409 WestonWeston, Florida, United States, 33327|Atlanta, Georgia, United States, 30342 AtlantaAtlanta, Georgia, United States, 30363 AugustaAugusta, Georgia, United States, 30912 College ParkCollege Park, Georgia, United States, 30349 DecaturDecatur, Georgia, United States, 30034 DuluthDuluth, Georgia, United States, 30097 NorcrossNorcross, Georgia, United States, 30093 SavannahSavannah, Georgia, United States, 31406|Idaho Falls, Idaho, United States, 83404|Chicago, Illinois, United States, 60611 NapervilleNaperville, Illinois, United States, 60540 OakbrookOakbrook Terrace, Illinois, United States, 60523|Shawnee Mission, Kansas, United States, 66218|Covington, Louisiana, United States, 70433 MarreroMarrero, Louisiana, United States, 70072 MetairieMetairie, Louisiana, United States, 70001 MetairieMetairie, Louisiana, United States, 70006|Baltimore, Maryland, United States, 21208 TowsonTowson, Maryland, United States, 21204|Canton, Michigan, United States, 48187 DetroitDetroit, Michigan, United States, 48201 SaginawSaginaw, Michigan, United States, 48604|Lincoln, Nebraska, United States, 68510 OmahaOmaha, Nebraska, United States, 68124|Las Vegas, Nevada, United States, 89106 Las VegasLas Vegas, Nevada, United States, 89109 Las VegasLas Vegas, Nevada, United States, 89113 Las VegasLas Vegas, Nevada, United States, 89128|Lawrenceville, New Jersey, United States, 08648|Albuquerque, New|Brooklyn, New York, United States, 11201 New YorkNew York, New York, United States, 10022 WilliamsvilleWilliamsville, New York, United States, 14221|Durham, North Carolina, United States, 27713 RaleighRaleigh, North Carolina, United States, 27607 RaleighRaleigh, North Carolina, United States, 27612 Winston-SalemWinston-Salem, North Carolina, United States, 27103|Cincinnati, Ohio, United States, 45212 CincinnatiCincinnati, Ohio, United States, 45219 ColumbusColumbus, Ohio, United States, 43231 EnglewoodEnglewood, Ohio, United States, 45322|Philadelphia, Pennsylvania, United States, 19104|Bluffton, South Carolina, United States, 29910 CharlestonCharleston, South Carolina, United States, 29406 ColumbiaColumbia, South Carolina, United States, 29201|Chattanooga, Tennessee, United States, 37404 MemphisMemphis, Tennessee, United States, 38119 MemphisMemphis, Tennessee, United States, 38120|Beaumont, Texas, United States, 77702 DallasDallas, Texas, United States, 75231 Fort WorthFort Worth, Texas, United States, 76104 FriscoFrisco, Texas, United States, 75035 HoustonHouston, Texas, United States, 77030 HoustonHouston, Texas, United States, 77054 HoustonHouston, Texas, United States, 77074 IrvingIrving, Texas, United States, 75062 LongviewLongview, Texas, United States, 75605 San AntonioSan Antonio, Texas, United States, 78229 San AntonioSan Antonio, Texas, United States, 78258 Sugar LandSugar Land, Texas, United States, 77479 WebsterWebster, Texas, United States, 77598|Salt Lake City, Utah, United States, 84107 Salt Lake CitySalt Lake City, Utah, United States, 84124|Norfolk, Virginia, United States, 23502 NorfolkNorfolk, Virginia, United States, 23507 RichmondRichmond, Virginia, United States, 23225|Seattle, Washington, United States, 98105 SpokaneSpokane, Washington, United States, 99207","Alabama|Arizona|Arkansas|California|Colorado|Florida|Georgia|Idaho|Illinois|Kansas|Louisiana|Maryland|Michigan|Nebraska|Nevada|New Jersey|New Mexico|New York|North Carolina|Ohio|Pennsylvania|South Carolina|Tennessee|Texas|Utah|Virginia|Washington","Belgium|Brazil|Chile|Czechia|Hungary|Italy|Poland|South Africa|United States","Brussels|Hainaut La LouviÃ¨re|Oost-Vlaanderen Gent|Botucatu|Santo Andre Santo Andre|Sao Paulo Santo AndrÃ©|Sao Paulo Sao Paulo|Providencia|Jihlava|Bacs-Kiskun KecskemÃ©t|Bekes Gyula|Debrecen|Hajdu-Bihar Debrecen|Szabolcs-Szatmar-Bereg NyÃ­regyhÃ¡za|Catanzaro|Bialystok|Lodzkie LÃ³dz|Lubelskie Lublin|Mazowieckie Warszawa|Slaskie Katowice|Wielkopolskie Poznan|Zachodniopomorskie Szczecin|, Gauteng Centurion|, Kwazulu-Natal Durban|Bloemfontein|Andaluisa|Mesa|Little Rock|Canoga Park|Denver|Aventura|Atlanta|Idaho Falls|Chicago|Shawnee|Covington|Baltimore|Canton|Lincoln|Las Vegas|Lawrenceville|Albuquerque|Brooklyn|Durham|Cincinnati|Philadelphia|Bluffton|Chattanooga|Beaumont|Salt Lake City|Norfolk|Seattle",{"$nulls":3},"Myovant Medical Monitor, MD","2020-02-12","2020-05-25T16:39:00.578","2020-05-26T17:10:42.972","NCT03412890"]
["5ecbf4a6fe30261b1a04837d","NCT03413319","2018-01-29","AbbVie","ABBV","Not yet recruiting","Extension Study of ABBV-8E12 in Patients With Progressive Supranuclear Palsy (PSP) Who Completed Study C2N-8E12-WW-104","Abbv-8e12",null,"Yes","['Abbv-8e12']","Unknown",null,"Phase 1",1,10,"Anticipated","2018-02-16","2020-09-20",{"$nulls":5},"The purpose of this study is to assess the long-term safety and tolerability of ABBV-8E12 in subjects with progressive supranuclear palsy (PSP).",null,"Extension Study of ABBV-8E12 in Patients With Progressive Supranuclear Palsy (PSP) Who Completed Study C2N-8E12-WW-104","M16-948","Progressive Supranuclear Palsy (PSP)","Supranuclear Palsy, Progressive","Central Nervous System Diseases","Central Nervous System","Experimental","ABBV-8E12","ABBV-8E12 administered by intravenous (IV) infusion.","Drug","ABBV-8E12","Solution for infusion",null,"ABBV-8E12","\n\n * Subject completed Study C2N-8E12-WW-104 (NCT02494024)\n * Subject was not eligible to enroll in Study M15-562 (NCT02985879)\n\n","\n\n * Subject weighs less than 35 kg at screening\n * Subject has any contraindication or inability to tolerate brain MRI\n * Subject has any significant change in his/her medical condition that could interfere with the subject's participation in the study, could place the subject at increased risk, or could confound interpretation of study results",{"$nulls":4},"Actual","2018-01-29","Actual","Anticipated","2020-09-20","Anticipated","2018-01-01","2018-01-23","2018-01-23","2018-01-23","No",null,"Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","18 Years","99 Years","All",null,"No","Undecided",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":14},"Adverse Events","Adverse events and serious adverse events will be monitored throughout the dosing period and for approximately 20 weeks after the last dose.","From first dose of study drug to 20 weeks after last dose of study drug (up to 2 years, 5 months)",{"$nulls":3},"abbvieclinicaltrials@abbvie.com","ABBVIE CALL CENTER","847.283.8955",{"$nulls":7},"AbbVie Inc.","2018-01-23","2020-05-25T16:39:02.287","2020-05-26T17:10:42.972","NCT03413319"]
["5ecbf4a7307e3d1b1f8d9e10","NCT03413319","2018-07-24","AbbVie","ABBV","Active, not recruiting","Extension Study of ABBV-8E12 in Patients With Progressive Supranuclear Palsy (PSP) Who Completed Study C2N-8E12-WW-104","Abbv-8e12",null,"Yes","['Abbv-8e12']","Unknown",null,"Phase 1",1,3,"Actual","2018-04-17","2020-09-20",{"$nulls":5},"The purpose of this study is to assess the long-term safety and tolerability of ABBV-8E12 in subjects with progressive supranuclear palsy (PSP).",null,"Extension Study of ABBV-8E12 in Patients With Progressive Supranuclear Palsy (PSP) Who Completed Study C2N-8E12-WW-104","M16-948","Progressive Supranuclear Palsy (PSP)","Supranuclear Palsy, Progressive","Central Nervous System Diseases","Central Nervous System","Experimental","ABBV-8E12","ABBV-8E12 administered by intravenous (IV) infusion.","Drug","ABBV-8E12","Solution for infusion",null,"ABBV-8E12","\n\n * Subject completed Study C2N-8E12-WW-104 (NCT02494024)\n * Subject was not eligible to enroll in Study M15-562 (NCT02985879)\n\n","\n\n * Subject weighs less than 35 kg at screening\n * Subject has any contraindication or inability to tolerate brain MRI\n * Subject has any significant change in his/her medical condition that could interfere with the subject's participation in the study, could place the subject at increased risk, or could confound interpretation of study results",{"$nulls":4},"Actual","2018-01-29","Actual","Anticipated","2020-10-19","Anticipated","2018-07-01","2018-01-23","2018-01-23","2018-07-23","No",null,"Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No","Undecided",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":14},"Adverse Events","Adverse events and serious adverse events will be monitored throughout the dosing period and for approximately 20 weeks after the last dose.","From first dose of study drug to 20 weeks after last dose of study drug (up to 2 years, 5 months)",{"$nulls":6},"La Jolla, California, United States, 92093|Dallas, Texas, United States, 75218","California|Texas","United States","University Of California, San /Id# 170113|Texas Health Physicians Group /Id# 170112",{"$nulls":3},"AbbVie Inc.","2018-07-23","2020-05-25T16:39:03.201","2020-05-26T17:10:42.972","NCT03413319"]
["5ecbf4a6307e3d1b1f8d9e0f","NCT03413319","2019-12-03","AbbVie","ABBV","Completed","Extension Study of ABBV-8E12 in Patients With Progressive Supranuclear Palsy (PSP) Who Completed Study C2N-8E12-WW-104","Abbv-8e12",null,"Yes","['Abbv-8e12']","Unknown",null,"Phase 1",1,3,"Actual","2018-04-17","2019-11-20",{"$nulls":5},"The purpose of this study is to assess the long-term safety and tolerability of ABBV-8E12 in subjects with progressive supranuclear palsy (PSP).",null,"Extension Study of ABBV-8E12 in Patients With Progressive Supranuclear Palsy (PSP) Who Completed Study C2N-8E12-WW-104","M16-948","Progressive Supranuclear Palsy (PSP)","Supranuclear Palsy, Progressive","Central Nervous System Diseases","Central Nervous System","Experimental","ABBV-8E12","ABBV-8E12 administered by intravenous (IV) infusion.","Drug","ABBV-8E12","Solution for infusion","Tilavonemab","ABBV-8E12","\n\n * Subject completed Study C2N-8E12-WW-104 (NCT02494024)\n * Subject was not eligible to enroll in Study M15-562 (NCT02985879)\n\n","\n\n * Subject weighs less than 35 kg at screening\n * Subject has any contraindication or inability to tolerate brain MRI\n * Subject has any significant change in his/her medical condition that could interfere with the subject's participation in the study, could place the subject at increased risk, or could confound interpretation of study results",{"$nulls":4},"Actual","2018-01-29","Actual","Actual","2019-11-20","Actual","2019-12-01","2018-01-23","2018-01-23","2019-12-02","No",null,"Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":14},"Adverse Events","Adverse events and serious adverse events will be monitored throughout the dosing period and for approximately 20 weeks after the last dose.","From first dose of study drug to 20 weeks after last dose of study drug (up to 2 years, 5 months)",{"$nulls":6},"La Jolla, California, United States, 92093|Dallas, Texas, United States, 75218","California|Texas","United States","University Of California, San /Id# 170113|Texas Health Physicians Group /Id# 170112",{"$nulls":3},"AbbVie Inc.","2019-12-02","2020-05-25T16:39:02.982","2020-05-26T17:10:42.972","NCT03413319"]
["5ecbf4ac11702c1b1b916b98","NCT03414047","2018-01-29","Eli Lilly","LLY","Not yet recruiting","A Study of Prexasertib (LY2606368) in Platinum-Resistant or Refractory Recurrent Ovarian Cancer","Prexasertib","CHK1 Inhibitor","Yes","['Prexasertib']","Yes","['CHK1 Inhibitor']","Phase 2",4,180,"Anticipated","2018-04-12","2019-04-16","RR|CR","Response Rate|Complete Response",{"$nulls":3},"The purpose of this study is to evaluate the efficacy and safety of prexasertib in women with platinum-resistant or refractory recurrent ovarian cancer.",null,"A Phase 2 Study of Prexasertib in Platinum-Resistant or Refractory Recurrent Ovarian Cancer",16712,"Ovarian Cancer","Ovarian Cancer","Oncology Solid Tumor","Oncology","Experimental","Prexasertib Cohort 1|Prexasertib Cohort 2|Prexasertib Cohort 3|Prexasertib Cohort 4","Participants with platinum-resistant disease that are breast cancer susceptibility gene (BRCA) negative and have received â‰¥3 lines of prior therapy.|Participants with platinum-resistant disease that are BRCA negative and have received <3 lines of prior therapy.|Participants with platinum-resistant disease that are BRCA positive and received a prior poly ADP ribose polymerase (PARP) inhibitor.|Participants with platinum refractory disease.","Drug","Prexasertib","Administered IV","LY2606368","Prexasertib Cohort 1|Prexasertib Cohort 2|Prexasertib Cohort 3|Prexasertib Cohort 4","\n\n * Women who have high-grade serous ovarian, primary peritoneal or fallopian tube cancer.\n * Cohorts 1 to 3: Have platinum-resistant disease and have documented test results assessing alterations in the BRCA1 and BRCA2 genes prior to receiving study treatment.\n * Cohort 1: Are BRCA negative and have received 3 or more prior lines of therapy.\n * Cohort 2: Are BRCA negative and have received less than 3 prior lines of therapy.\n * Cohort 3: Are BRCA positive and have previously received a PARP.\n * Cohort 4: Have primary platinum refractory disease.\n * Have adequate organ function.\n * Must be able and willing to undergo mandatory tumor biopsy.\n\n","\n\n * Cohorts 1-3: Have previously received all of the following agents at any time in the platinum-resistant setting: gemcitabine, pegylated liposomal doxorubicin, and paclitaxel.\n * Have known central nervous system malignancy or metastasis.\n * Have previously participated in any study involving a checkpoint kinase 1 inhibitor or have hypersensitivity to the study drug or excipients.\n * Have at least one of the following: * history of abdominal fistula or gastrointestinal perforation\n    * intra-abdominal abscess within last 3 months prior to the first dose of study drug\n    * a radiographically confirmed bowel obstruction within 3 months prior to the first dose of study drug\n   \n   \n * Have a symptomatic human immunodeficiency virus infection or symptomatic activated/reactivated hepatitis A, B, or C (screening is not required).\n * Have a serious cardiac condition.\n * Have a history of prior radiotherapy to the whole pelvis.\n * Have chronic daily treatment with corticosteroids, excluding inhaled steroids.","BRCA",null,"Protein","Breast","Actual","2018-01-29","Actual","Anticipated","2019-04-16","Anticipated","2018-01-01","2018-01-12","2018-01-22","2018-01-22","No","DNA damage repair\nreplication stress","Interventional","Treatment","Parallel Assignment","None (Open Label)","Non-Randomized","18 Years",null,"Female",null,"No","Yes\nLilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com. This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.",{"$nulls":3},"Yes","No",{"$nulls":17},"I4D-MC-JTJN|2017-004009-42","Eli Lilly and Company|EudraCT Number","Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR): Overall Response Rate (ORR)","Percentage of participants who achieve CR or PR: ORR","Baseline through Disease Progression (estimated at up to 12 months)","Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of Prexasertib|Disease Control Rate (DCR): Proportion of Participants with a Best Overall Response of CR, PR, or Stable Disease (SD) for at Least 4 Months|Duration of Response|Percentage of Participants with at Least a 50% Reduction in CA-125 Levels from Baseline|Progression-Free Survival|Overall Survival","PK: Cmax of prexasertib on day 1 of cycles 1, 2, 4 and 6|DCR: Percentage of participants with a best overall response of CR, PR, or SD for at least 4 months|Duration of response|Percentage of participants with at least a 50% reduction in CA-125 levels from baseline|Progression-free survival|Overall survival","Cycle 1 End of Infusion (Day 1) up to 1-2 Hours Following End of Infusion on Day 1 of Cycle 6 (each cycle is 28 days)|Baseline through Disease Progression (estimated at up to 12 months)|Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (estimated at up to 24 months)|Baseline, 4 Weeks|Baseline to Disease Progression or Death from any Cause (estimated at up to 12 months)|Baseline to Date of Death from Any Cause (estimated at up to 24 months)","Clinicaltrials.gov@lilly.com","There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or","1-317-615-4559","Bedford Park, Australia, 5042|Brussels, Belgium, 1000|Haifa, Israel, 3109601|Milano, Italy, 20133|Barcelona, Spain, 08035|Glasgow, United Kingdom, G12 0Yn|Tucson, Arizona, United States, 85710|Sacramento, California, United States, 95817|Boston, Massachusetts, United States, 02215|Tulsa, Oklahoma, United States, 74146|Philadelphia, Pennsylvania, United States, 19107|Providence, Rhode Island, United States, 02903|Knoxville, Tennessee, United States, 37920","Arizona|California|Massachusetts|Oklahoma|Pennsylvania|Rhode Island|Tennessee","Australia|Belgium|Israel|Italy|Spain|United Kingdom|United States","For Additional Information Regarding Investigative Sites For This Trial, Contact 1-877-Ctlilly (1-877-285-4559, 1-317-615-4559) Mon - Fri From 9 Am To 5 Pm Eastern Time (Utc/Gmt - 5 Hours, Est), Or Speak With Your Personal Physician.|For Additional Information Regarding Investigative Sites For This Trial, Contact 1-888-545-5972 Mon - Fri, 9 Am To 4 Pm Or 1-877-Ctlilly (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 Am To 5 Pm Eastern Time Or Speak With Your Personal Physician.|Arizona Oncology Associates, P.C.|University Of California, Davis - Health Systems|Dana Farber Cancer Institute|Cancer Care Associates|Thomas Jefferson University|Rhode Island Hospital|University Of Tennessee Medical Center",{"$nulls":3},"Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)","2018-01-22","2020-05-25T16:39:08.646","2020-05-26T17:10:42.972","NCT03414047"]
["5ecbf4ac11702c1b1b916b99","NCT03414047","2018-02-05","Eli Lilly","LLY","Not yet recruiting","A Study of Prexasertib (LY2606368) in Platinum-Resistant or Refractory Recurrent Ovarian Cancer","Prexasertib","CHK1 Inhibitor","Yes","['Prexasertib']","Yes","['CHK1 Inhibitor']","Phase 2",4,180,"Anticipated","2018-04-12","2019-04-16","RR|CR","Response Rate|Complete Response",{"$nulls":3},"The purpose of this study is to evaluate the efficacy and safety of prexasertib in women with platinum-resistant or refractory recurrent ovarian cancer.",null,"A Phase 2 Study of Prexasertib in Platinum-Resistant or Refractory Recurrent Ovarian Cancer",16712,"Ovarian Cancer","Ovarian Cancer","Oncology Solid Tumor","Oncology","Experimental","Prexasertib Cohort 1|Prexasertib Cohort 2|Prexasertib Cohort 3|Prexasertib Cohort 4","Participants with platinum-resistant disease that are breast cancer susceptibility gene (BRCA) negative and have received â‰¥3 lines of prior therapy.|Participants with platinum-resistant disease that are BRCA negative and have received <3 lines of prior therapy.|Participants with platinum-resistant disease that are BRCA positive and received a prior poly ADP ribose polymerase (PARP) inhibitor.|Participants with platinum refractory disease.","Drug","Prexasertib","Administered IV","LY2606368","Prexasertib Cohort 1|Prexasertib Cohort 2|Prexasertib Cohort 3|Prexasertib Cohort 4","\n\n * Women who have high-grade serous ovarian, primary peritoneal or fallopian tube cancer.\n * Cohorts 1 to 3: Have platinum-resistant disease and have documented test results assessing alterations in the BRCA1 and BRCA2 genes prior to receiving study treatment.\n * Cohort 1: Are BRCA negative and have received 3 or more prior lines of therapy.\n * Cohort 2: Are BRCA negative and have received less than 3 prior lines of therapy.\n * Cohort 3: Are BRCA positive and have previously received a PARP.\n * Cohort 4: Have primary platinum refractory disease.\n * Have adequate organ function.\n * Must be able and willing to undergo mandatory tumor biopsy.\n\n","\n\n * Cohorts 1-3: Have previously received all of the following agents at any time in the platinum-resistant setting: gemcitabine, pegylated liposomal doxorubicin, and paclitaxel.\n * Have known central nervous system malignancy or metastasis.\n * Have previously participated in any study involving a checkpoint kinase 1 inhibitor or have hypersensitivity to the study drug or excipients.\n * Have at least one of the following: * history of abdominal fistula or gastrointestinal perforation\n    * intra-abdominal abscess within last 3 months prior to the first dose of study drug\n    * a radiographically confirmed bowel obstruction within 3 months prior to the first dose of study drug\n   \n   \n * Have a symptomatic human immunodeficiency virus infection or symptomatic activated/reactivated hepatitis A, B, or C (screening is not required).\n * Have a serious cardiac condition.\n * Have a history of prior radiotherapy to the whole pelvis.\n * Have chronic daily treatment with corticosteroids, excluding inhaled steroids.","BRCA",null,"Protein","Breast","Actual","2018-01-29","Actual","Anticipated","2019-04-16","Anticipated","2018-02-01","2018-01-12","2018-01-22","2018-02-02","No","DNA damage repair\nreplication stress","Interventional","Treatment","Parallel Assignment","None (Open Label)","Non-Randomized","18 Years",null,"Female",null,"No","Yes\nLilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com. This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.",{"$nulls":3},"Yes","No",{"$nulls":17},"I4D-MC-JTJN|2017-004009-42","Eli Lilly and Company|EudraCT Number","Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR): Overall Response Rate (ORR)","Percentage of participants who achieve CR or PR: ORR","Baseline through Disease Progression (estimated at up to 12 months)","Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of Prexasertib|Disease Control Rate (DCR): Proportion of Participants with a Best Overall Response of CR, PR, or Stable Disease (SD) for at Least 4 Months|Duration of Response|Percentage of Participants with at Least a 50% Reduction in CA-125 Levels from Baseline|Progression-Free Survival|Overall Survival","PK: Cmax of prexasertib on day 1 of cycles 1, 2, 4 and 6|DCR: Percentage of participants with a best overall response of CR, PR, or SD for at least 4 months|Duration of response|Percentage of participants with at least a 50% reduction in CA-125 levels from baseline|Progression-free survival|Overall survival","Cycle 1 End of Infusion (Day 1) up to 1-2 Hours Following End of Infusion on Day 1 of Cycle 6 (each cycle is 28 days)|Baseline through Disease Progression (estimated at up to 12 months)|Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (estimated at up to 24 months)|Baseline, 4 Weeks|Baseline to Disease Progression or Death from any Cause (estimated at up to 12 months)|Baseline to Date of Death from Any Cause (estimated at up to 24 months)","Clinicaltrials.gov@lilly.com","There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or","1-317-615-4559","Bedford Park, Australia, 5042|Brussels, Belgium, 1000|Haifa, Israel, 3109601|Milano, Italy, 20133|Barcelona, Spain, 08035|Glasgow, United Kingdom, G12 0Yn|Tucson, Arizona, United States, 85710|Sacramento, California, United States, 95817|Boston, Massachusetts, United States, 02215|Kansas City, Missouri, United States, 63142|Tulsa, Oklahoma, United States, 74146|Philadelphia, Pennsylvania, United States, 19107|Providence, Rhode Island, United States, 02903|Knoxville, Tennessee, United States, 37920","Arizona|California|Massachusetts|Missouri|Oklahoma|Pennsylvania|Rhode Island|Tennessee","Australia|Belgium|Israel|Italy|Spain|United Kingdom|United States","For Additional Information Regarding Investigative Sites For This Trial, Contact 1-877-Ctlilly (1-877-285-4559, 1-317-615-4559) Mon - Fri From 9 Am To 5 Pm Eastern Time (Utc/Gmt - 5 Hours, Est), Or Speak With Your Personal Physician.|For Additional Information Regarding Investigative Sites For This Trial, Contact 1-888-545-5972 Mon - Fri, 9 Am To 4 Pm Or 1-877-Ctlilly (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 Am To 5 Pm Eastern Time Or Speak With Your Personal Physician.|Arizona Oncology Associates, P.C.|University Of California, Davis - Health Systems|Dana Farber Cancer Institute|Research Medical Center|Cancer Care Associates|Thomas Jefferson University|Rhode Island Hospital|University Of Tennessee Medical Center",{"$nulls":3},"Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)","2018-02-02","2020-05-25T16:39:08.792","2020-05-26T17:10:42.972","NCT03414047"]
["5ecbf4ace2561b1b11905e86","NCT03414047","2018-03-20","Eli Lilly","LLY","Not yet recruiting","A Study of Prexasertib (LY2606368) in Platinum-Resistant or Refractory Recurrent Ovarian Cancer","Prexasertib","CHK1 Inhibitor","Yes","['Prexasertib']","Yes","['CHK1 Inhibitor']","Phase 2",4,180,"Anticipated","2018-04-12","2019-04-16","RR|CR","Response Rate|Complete Response",{"$nulls":3},"The purpose of this study is to evaluate the efficacy and safety of prexasertib in women with platinum-resistant or refractory recurrent ovarian cancer.",null,"A Phase 2 Study of Prexasertib in Platinum-Resistant or Refractory Recurrent Ovarian Cancer",16712,"Ovarian Cancer","Ovarian Cancer","Oncology Solid Tumor","Oncology","Experimental","Prexasertib Cohort 1|Prexasertib Cohort 2|Prexasertib Cohort 3|Prexasertib Cohort 4","Participants with platinum-resistant disease that are breast cancer susceptibility gene (BRCA) negative and have received â‰¥3 lines of prior therapy.|Participants with platinum-resistant disease that are BRCA negative and have received <3 lines of prior therapy.|Participants with platinum-resistant disease that are BRCA positive and received a prior poly ADP ribose polymerase (PARP) inhibitor.|Participants with platinum refractory disease.","Drug","Prexasertib","Administered IV","LY2606368","Prexasertib Cohort 1|Prexasertib Cohort 2|Prexasertib Cohort 3|Prexasertib Cohort 4","\n\n * Women who have high-grade serous ovarian, primary peritoneal or fallopian tube cancer.\n * Cohorts 1 to 3: Have platinum-resistant disease and have documented test results assessing alterations in the BRCA1 and BRCA2 genes prior to receiving study treatment.\n * Cohort 1: Are BRCA negative and have received 3 or more prior lines of therapy.\n * Cohort 2: Are BRCA negative and have received less than 3 prior lines of therapy.\n * Cohort 3: Are BRCA positive and have previously received a PARP.\n * Cohort 4: Have primary platinum refractory disease.\n * Have adequate organ function.\n * Must be able and willing to undergo mandatory tumor biopsy.\n\n","\n\n * Cohorts 1-3: Have previously received all of the following agents at any time in the platinum-resistant setting: gemcitabine, pegylated liposomal doxorubicin, and paclitaxel.\n * Have known central nervous system malignancy or metastasis.\n * Have previously participated in any study involving a checkpoint kinase 1 inhibitor or have hypersensitivity to the study drug or excipients.\n * Have at least one of the following: * history of abdominal fistula or gastrointestinal perforation\n    * intra-abdominal abscess within last 3 months prior to the first dose of study drug\n    * a radiographically confirmed bowel obstruction within 3 months prior to the first dose of study drug\n   \n   \n * Have a symptomatic human immunodeficiency virus infection or symptomatic activated/reactivated hepatitis A, B, or C (screening is not required).\n * Have a serious cardiac condition.\n * Have a history of prior radiotherapy to the whole pelvis.\n * Have chronic daily treatment with corticosteroids, excluding inhaled steroids.","BRCA",null,"Protein","Breast","Actual","2018-01-29","Actual","Anticipated","2019-04-16","Anticipated","2018-03-01","2018-01-12","2018-01-22","2018-03-19","No","DNA damage repair\nreplication stress","Interventional","Treatment","Parallel Assignment","None (Open Label)","Non-Randomized","18 Years",null,"Female",null,"No","Yes\nLilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com. This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.",null,"URL: https://www.lillytrialguide.com/en-US/studies/ovarian-cancer/JTJN#?postal= [https://www.lillytrialguide.com/en-US/studies/ovarian-cancer/JTJN#?postal=] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: A Study of Prexasertib (LY2606368) in Platinum-Resistant or Refractory Recurrent Ovarian Cancer",null,"Yes","No",{"$nulls":17},"I4D-MC-JTJN|2017-004009-42","Eli Lilly and Company|EudraCT Number","Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR): Overall Response Rate (ORR)","Percentage of participants who achieve CR or PR: ORR","Baseline through Disease Progression (estimated at up to 12 months)","Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of Prexasertib|Disease Control Rate (DCR): Proportion of Participants with a Best Overall Response of CR, PR, or Stable Disease (SD) for at Least 4 Months|Duration of Response|Percentage of Participants with at Least a 50% Reduction in CA-125 Levels from Baseline|Progression-Free Survival|Overall Survival","PK: Cmax of prexasertib on day 1 of cycles 1, 2, 4 and 6|DCR: Percentage of participants with a best overall response of CR, PR, or SD for at least 4 months|Duration of response|Percentage of participants with at least a 50% reduction in CA-125 levels from baseline|Progression-free survival|Overall survival","Cycle 1 End of Infusion (Day 1) up to 1-2 Hours Following End of Infusion on Day 1 of Cycle 6 (each cycle is 28 days)|Baseline through Disease Progression (estimated at up to 12 months)|Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (estimated at up to 24 months)|Baseline, 4 Weeks|Baseline to Disease Progression or Death from any Cause (estimated at up to 12 months)|Baseline to Date of Death from Any Cause (estimated at up to 24 months)","Clinicaltrials.gov@lilly.com","There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or","1-317-615-4559","Bedford Park, Australia, 5042|Brussels, Belgium, 1000|Haifa, Israel, 3109601|Milano, Italy, 20133|Barcelona, Spain, 08035|Glasgow, United Kingdom, G12 0Yn|Tucson, Arizona, United States, 85711|Sacramento, California, United States, 95817|Sarasota, Florida, United States, 34239-3555|Boston, Massachusetts, United States, 02115|Kansas City, Missouri, United States, 63142|Tulsa, Oklahoma, United States, 74146|Philadelphia, Pennsylvania, United States, 19107|Providence, Rhode Island, United States, 02903|Sioux Falls, South Dakota, United States, 57104|Knoxville, Tennessee, United States, 37920|Seattle, Washington, United States, 98109","Arizona|California|Florida|Massachusetts|Missouri|Oklahoma|Pennsylvania|Rhode Island|South Dakota|Tennessee|Washington","Australia|Belgium|Israel|Italy|Spain|United Kingdom|United States","For Additional Information Regarding Investigative Sites For This Trial, Contact 1-877-Ctlilly (1-877-285-4559, 1-317-615-4559) Mon - Fri From 9 Am To 5 Pm Eastern Time (Utc/Gmt - 5 Hours, Est), Or Speak With Your Personal Physician.|For Additional Information Regarding Investigative Sites For This Trial, Contact 1-888-545-5972 Mon - Fri, 9 Am To 4 Pm Or 1-877-Ctlilly (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 Am To 5 Pm Eastern Time Or Speak With Your Personal Physician.|Arizona Oncology Associates, P.C.|University Of California, Davis - Health Systems|Sarasota Memorial Hospital|Dana Farber Cancer Institute|Research Medical Center|Cancer Care Associates|Thomas Jefferson University|Rhode Island Hospital|Sioux Valley Clinic|University Of Tennessee Medical Center|University Of Washington Medical Center",{"$nulls":3},"Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)","2018-03-19","2020-05-25T16:39:08.792","2020-05-26T17:10:42.972","NCT03414047"]
["5ecbf4adfe30261b1a04838d","NCT03414047","2018-04-23","Eli Lilly","LLY","Recruiting","A Study of Prexasertib (LY2606368) in Platinum-Resistant or Refractory Recurrent Ovarian Cancer","Prexasertib","CHK1 Inhibitor","Yes","['Prexasertib']","Yes","['CHK1 Inhibitor']","Phase 2",4,180,"Anticipated","2018-04-09","2019-04-16","RR|CR","Response Rate|Complete Response",{"$nulls":3},"The purpose of this study is to evaluate the efficacy and safety of prexasertib in women with platinum-resistant or refractory recurrent ovarian cancer.",null,"A Phase 2 Study of Prexasertib in Platinum-Resistant or Refractory Recurrent Ovarian Cancer",16712,"Ovarian Cancer","Ovarian Cancer","Oncology Solid Tumor","Oncology","Experimental","Prexasertib Cohort 1|Prexasertib Cohort 2|Prexasertib Cohort 3|Prexasertib Cohort 4","Participants with platinum-resistant disease that are breast cancer susceptibility gene (BRCA) negative and have received â‰¥3 lines of prior therapy.|Participants with platinum-resistant disease that are BRCA negative and have received <3 lines of prior therapy.|Participants with platinum-resistant disease that are BRCA positive and received a prior poly ADP ribose polymerase (PARP) inhibitor.|Participants with platinum refractory disease.","Drug","Prexasertib","Administered IV","LY2606368","Prexasertib Cohort 1|Prexasertib Cohort 2|Prexasertib Cohort 3|Prexasertib Cohort 4","\n\n * Women who have high-grade serous ovarian, primary peritoneal or fallopian tube cancer.\n * Cohorts 1 to 3: Have platinum-resistant disease and have documented test results assessing alterations in the BRCA1 and BRCA2 genes prior to receiving study treatment.\n * Cohort 1: Are BRCA negative and have received 3 or more prior lines of therapy.\n * Cohort 2: Are BRCA negative and have received less than 3 prior lines of therapy.\n * Cohort 3: Are BRCA positive and have previously received a PARP.\n * Cohort 4: Have primary platinum refractory disease.\n * Have adequate organ function.\n * Must be able and willing to undergo mandatory tumor biopsy.\n\n","\n\n * Cohorts 1-3: Have previously received all of the following agents at any time in the platinum-resistant setting: gemcitabine, pegylated liposomal doxorubicin, and paclitaxel.\n * Have known central nervous system malignancy or metastasis.\n * Have previously participated in any study involving a checkpoint kinase 1 inhibitor or have hypersensitivity to the study drug or excipients.\n * Have at least one of the following: * history of abdominal fistula or gastrointestinal perforation\n    * intra-abdominal abscess within last 3 months prior to the first dose of study drug\n    * a radiographically confirmed bowel obstruction within 3 months prior to the first dose of study drug\n   \n   \n * Have a symptomatic human immunodeficiency virus infection or symptomatic activated/reactivated hepatitis A, B, or C (screening is not required).\n * Have a serious cardiac condition.\n * Have a history of prior radiotherapy to the whole pelvis.\n * Have chronic daily treatment with corticosteroids, excluding inhaled steroids.","BRCA",null,"Protein","Breast","Actual","2018-01-29","Actual","Anticipated","2019-04-16","Anticipated","2018-04-01","2018-01-12","2018-01-22","2018-04-20","No","DNA damage repair\nreplication stress","Interventional","Treatment","Parallel Assignment","None (Open Label)","Non-Randomized","18 Years",null,"Female",null,"No","Yes\nLilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com. This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.",null,"URL: https://www.lillytrialguide.com/en-US/studies/ovarian-cancer/JTJN#?postal= [https://www.lillytrialguide.com/en-US/studies/ovarian-cancer/JTJN#?postal=] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: A Study of Prexasertib (LY2606368) in Platinum-Resistant or Refractory Recurrent Ovarian Cancer",null,"Yes","No",{"$nulls":17},"I4D-MC-JTJN|2017-004009-42","Eli Lilly and Company|EudraCT Number","Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR): Overall Response Rate (ORR)","Percentage of participants who achieve CR or PR: ORR","Baseline through Disease Progression (estimated at up to 12 months)","Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of Prexasertib|Disease Control Rate (DCR): Proportion of Participants with a Best Overall Response of CR, PR, or Stable Disease (SD) for at Least 4 Months|Duration of Response|Percentage of Participants with at Least a 50% Reduction in CA-125 Levels from Baseline|Progression-Free Survival|Overall Survival","PK: Cmax of prexasertib on day 1 of cycles 1, 2, 4 and 6|DCR: Percentage of participants with a best overall response of CR, PR, or SD for at least 4 months|Duration of response|Percentage of participants with at least a 50% reduction in CA-125 levels from baseline|Progression-free survival|Overall survival","Cycle 1 End of Infusion (Day 1) up to 1-2 Hours Following End of Infusion on Day 1 of Cycle 6 (each cycle is 28 days)|Baseline through Disease Progression (estimated at up to 12 months)|Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (estimated at up to 24 months)|Baseline, 4 Weeks|Baseline to Disease Progression or Death from any Cause (estimated at up to 12 months)|Baseline to Date of Death from Any Cause (estimated at up to 24 months)","Clinicaltrials.gov@lilly.com","There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or","1-317-615-4559","Bedford Park, Australia, 5042|Brussels, Belgium, 1000|Haifa, Israel, 3109601|Milano, Italy, 20133|Barcelona, Spain, 08035|Glasgow, United Kingdom, G12 0Yn|Tucson, Arizona, United States, 85711|Sacramento, California, United States, 95817|Gainesville, Florida, United States, 32610-0296|Boston, Massachusetts, United States, 02115|Kansas City, Missouri, United States, 63142|Tulsa, Oklahoma, United States, 74146|Philadelphia, Pennsylvania, United States, 19107|Providence, Rhode Island, United States, 02903|Sioux Falls, South Dakota, United States, 57104|Knoxville, Tennessee, United States, 37920|Seattle, Washington, United States, 98109","Arizona|California|Florida|Massachusetts|Missouri|Oklahoma|Pennsylvania|Rhode Island|South Dakota|Tennessee|Washington","Australia|Belgium|Israel|Italy|Spain|United Kingdom|United States","For Additional Information Regarding Investigative Sites For This Trial, Contact 1-877-Ctlilly (1-877-285-4559, 1-317-615-4559) Mon - Fri From 9 Am To 5 Pm Eastern Time (Utc/Gmt - 5 Hours, Est), Or Speak With Your Personal Physician.|For Additional Information Regarding Investigative Sites For This Trial, Contact 1-888-545-5972 Mon - Fri, 9 Am To 4 Pm Or 1-877-Ctlilly (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 Am To 5 Pm Eastern Time Or Speak With Your Personal Physician.|Arizona Oncology Associates, P.C.|University Of California, Davis - Health Systems|University Of Southern Florida School Of Medicine|Dana Farber Cancer Institute|Research Medical Center|Cancer Care Associates|Thomas Jefferson University|Rhode Island Hospital|Sioux Valley Clinic|University Of Tennessee Medical Center|University Of Washington Medical Center",{"$nulls":3},"Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)","2018-04-20","2020-05-25T16:39:09.064","2020-05-26T17:10:42.972","NCT03414047"]
["5ecbf4adfe30261b1a04838e","NCT03414047","2018-07-18","Eli Lilly","LLY","Recruiting","A Study of Prexasertib (LY2606368) in Platinum-Resistant or Refractory Recurrent Ovarian Cancer","Prexasertib","CHK1 Inhibitor","Yes","['Prexasertib']","Yes","['CHK1 Inhibitor']","Phase 2",4,180,"Anticipated","2018-04-09","2019-04-16","RR|CR","Response Rate|Complete Response",{"$nulls":3},"The purpose of this study is to evaluate the efficacy and safety of prexasertib in women with platinum-resistant or refractory recurrent ovarian cancer.",null,"A Phase 2 Study of Prexasertib in Platinum-Resistant or Refractory Recurrent Ovarian Cancer",16712,"Ovarian Cancer","Ovarian Cancer","Oncology Solid Tumor","Oncology","Experimental","Prexasertib Cohort 1|Prexasertib Cohort 2|Prexasertib Cohort 3|Prexasertib Cohort 4","Participants with platinum-resistant disease that are breast cancer susceptibility gene (BRCA) negative and have received â‰¥3 lines of prior therapy.|Participants with platinum-resistant disease that are BRCA negative and have received <3 lines of prior therapy.|Participants with platinum-resistant disease that are BRCA positive and received a prior poly ADP ribose polymerase (PARP) inhibitor.|Participants with platinum refractory disease.","Drug","Prexasertib","Administered IV","LY2606368","Prexasertib Cohort 1|Prexasertib Cohort 2|Prexasertib Cohort 3|Prexasertib Cohort 4","\n\n * Women who have high-grade serous ovarian, primary peritoneal or fallopian tube cancer.\n * Cohorts 1 to 3: Have platinum-resistant disease and have documented test results assessing alterations in the BRCA1 and BRCA2 genes prior to receiving study treatment.\n * Cohort 1: Are BRCA negative and have received 3 or more prior lines of therapy.\n * Cohort 2: Are BRCA negative and have received less than 3 prior lines of therapy.\n * Cohort 3: Are BRCA positive and have previously received a PARP.\n * Cohort 4: Have primary platinum refractory disease.\n * Have adequate organ function.\n * Must be able and willing to undergo mandatory tumor biopsy.\n\n","\n\n * Cohorts 1-3: Have previously received all of the following agents at any time in the platinum-resistant setting: gemcitabine, pegylated liposomal doxorubicin, and paclitaxel.\n * Have known central nervous system malignancy or metastasis.\n * Have previously participated in any study involving a checkpoint kinase 1 inhibitor or have hypersensitivity to the study drug or excipients.\n * Have at least one of the following: * history of abdominal fistula or gastrointestinal perforation\n    * intra-abdominal abscess within last 3 months prior to the first dose of study drug\n    * a radiographically confirmed bowel obstruction within 3 months prior to the first dose of study drug\n   \n   \n * Have a symptomatic human immunodeficiency virus infection or symptomatic activated/reactivated hepatitis A, B, or C (screening is not required).\n * Have a serious cardiac condition.\n * Have a history of prior radiotherapy to the whole pelvis.\n * Have chronic daily treatment with corticosteroids, excluding inhaled or topical steroids.\n * Have known factors that may increase the risk of infection while on study drug treatment. These may include, but are not limited to, an indwelling peritoneal catheter or open wounds. Catheters for vascular access are permitted.","BRCA",null,"Protein","Breast","Actual","2018-01-29","Actual","Anticipated","2019-04-16","Anticipated","2018-07-01","2018-01-12","2018-01-22","2018-07-17","No","DNA damage repair\nreplication stress","Interventional","Treatment","Parallel Assignment","None (Open Label)","Non-Randomized","18 Years",null,"Female",null,"No","Yes\nLilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com. This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.",null,"URL: https://www.lillytrialguide.com/en-US/studies/ovarian-cancer/JTJN#?postal= [https://www.lillytrialguide.com/en-US/studies/ovarian-cancer/JTJN#?postal=] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: A Study of Prexasertib (LY2606368) in Platinum-Resistant or Refractory Recurrent Ovarian Cancer",null,"Yes","No",{"$nulls":17},"I4D-MC-JTJN|2017-004009-42","Eli Lilly and Company|EudraCT Number","Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR): Overall Response Rate (ORR)","Percentage of participants who achieve CR or PR: ORR","Baseline through Disease Progression (estimated at up to 12 months)","Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of Prexasertib|Disease Control Rate (DCR): Proportion of Participants with a Best Overall Response of CR, PR, or Stable Disease (SD) for at Least 4 Months|Duration of Response|Percentage of Participants with at Least a 50% Reduction in CA-125 Levels from Baseline|Progression-Free Survival|Overall Survival","PK: Cmax of prexasertib on day 1 of cycles 1, 2, 4 and 6|DCR: Percentage of participants with a best overall response of CR, PR, or SD for at least 4 months|Duration of response|Percentage of participants with at least a 50% reduction in CA-125 levels from baseline|Progression-free survival|Overall survival","Cycle 1 End of Infusion (Day 1) up to 1-2 Hours Following End of Infusion on Day 1 of Cycle 6 (each cycle is 28 days)|Baseline through Disease Progression (estimated at up to 12 months)|Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (estimated at up to 24 months)|Baseline, 4 Weeks|Baseline to Disease Progression or Death from any Cause (estimated at up to 12 months)|Baseline to Date of Death from Any Cause (estimated at up to 24 months)","Clinicaltrials.gov@lilly.com","There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or","1-317-615-4559","Bedford Park, Australia, 5042|Brussels, Belgium, 1000|Haifa, Israel, 3109601|Milano, Italy, 20133|Barcelona, Spain, 08035|Glasgow, United Kingdom, G12 0Yn|Tucson, Arizona, United States, 85711|Sacramento, California, United States, 95817|Gainesville, Florida, United States, 32610-0296|Boston, Massachusetts, United States, 02215|Kansas City, Missouri, United States, 63142|Tulsa, Oklahoma, United States, 74146|Philadelphia, Pennsylvania, United States, 19107|Providence, Rhode Island, United States, 02903|Sioux Falls, South Dakota, United States, 57104|Knoxville, Tennessee, United States, 37920|Seattle, Washington, United States, 98109","Arizona|California|Florida|Massachusetts|Missouri|Oklahoma|Pennsylvania|Rhode Island|South Dakota|Tennessee|Washington","Australia|Belgium|Israel|Italy|Spain|United Kingdom|United States","For Additional Information Regarding Investigative Sites For This Trial, Contact 1-877-Ctlilly (1-877-285-4559, 1-317-615-4559) Mon - Fri From 9 Am To 5 Pm Eastern Time (Utc/Gmt - 5 Hours, Est), Or Speak With Your Personal Physician.|For Additional Information Regarding Investigative Sites For This Trial, Contact 1-888-545-5972 Mon - Fri, 9 Am To 4 Pm Or 1-877-Ctlilly (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 Am To 5 Pm Eastern Time Or Speak With Your Personal Physician.|Arizona Oncology Associates, P.C.|University Of California, Davis - Health Systems|University Of Southern Florida School Of Medicine|Dana Farber Cancer Institute|Research Medical Center|Cancer Care Associates|Thomas Jefferson University|Rhode Island Hospital|Sioux Valley Clinic|University Of Tennessee Medical Center|University Of Washington Medical Center",{"$nulls":3},"Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)","2018-07-17","2020-05-25T16:39:09.328","2020-05-26T17:10:42.972","NCT03414047"]
["5ecbf4ad11702c1b1b916b9b","NCT03414047","2018-10-04","Eli Lilly","LLY","Recruiting","A Study of Prexasertib (LY2606368) in Platinum-Resistant or Refractory Recurrent Ovarian Cancer","Prexasertib","CHK1 Inhibitor","Yes","['Prexasertib']","Yes","['CHK1 Inhibitor']","Phase 2",4,180,"Anticipated","2018-04-10","2019-04-16","RR|CR","Response Rate|Complete Response",{"$nulls":3},"The purpose of this study is to evaluate the efficacy and safety of prexasertib in women with platinum-resistant or refractory recurrent ovarian cancer.",null,"A Phase 2 Study of Prexasertib in Platinum-Resistant or Refractory Recurrent Ovarian Cancer",16712,"Ovarian Cancer","Ovarian Cancer","Oncology Solid Tumor","Oncology","Experimental","Prexasertib Cohort 1|Prexasertib Cohort 2|Prexasertib Cohort 3|Prexasertib Cohort 4","Participants with platinum-resistant disease that are breast cancer susceptibility gene (BRCA) negative and have received â‰¥3 lines of prior therapy.|Participants with platinum-resistant disease that are BRCA negative and have received <3 lines of prior therapy.|Participants with platinum-resistant disease that are BRCA positive and received a prior poly ADP ribose polymerase (PARP) inhibitor.|Participants with platinum refractory disease.","Drug","Prexasertib","Administered IV","LY2606368","Prexasertib Cohort 1|Prexasertib Cohort 2|Prexasertib Cohort 3|Prexasertib Cohort 4","\n\n * Women who have high-grade serous ovarian, primary peritoneal or fallopian tube cancer.\n * Cohorts 1 to 3: Have platinum-resistant disease and have documented test results assessing alterations in the BRCA1 and BRCA2 genes prior to receiving study treatment.\n * Cohort 1: Are BRCA negative and have received 3 or more prior lines of therapy.\n * Cohort 2: Are BRCA negative and have received less than 3 prior lines of therapy.\n * Cohort 3: Are BRCA positive and have previously received a PARP.\n * Cohort 4: Have primary platinum refractory disease.\n * Have adequate organ function.\n * Must be able and willing to undergo mandatory tumor biopsy.\n\n","\n\n * Cohorts 1-3: Have previously received all of the following agents at any time in the platinum-resistant setting: gemcitabine, pegylated liposomal doxorubicin, and paclitaxel.\n * Have known central nervous system malignancy or metastasis.\n * Have previously participated in any study involving a checkpoint kinase 1 inhibitor or have hypersensitivity to the study drug or excipients.\n * Have at least one of the following: * history of abdominal fistula or gastrointestinal perforation\n    * intra-abdominal abscess within last 3 months prior to the first dose of study drug\n    * a radiographically confirmed bowel obstruction within 3 months prior to the first dose of study drug\n   \n   \n * Have a symptomatic human immunodeficiency virus infection or symptomatic activated/reactivated hepatitis A, B, or C (screening is not required).\n * Have a serious cardiac condition.\n * Have a history of prior radiotherapy to the whole pelvis.\n * Have chronic daily treatment with corticosteroids, excluding inhaled or topical steroids.\n * Have known factors that may increase the risk of infection while on study drug treatment. These may include, but are not limited to, an indwelling peritoneal catheter or open wounds. Catheters for vascular access are permitted.","BRCA",null,"Protein","Breast","Actual","2018-01-29","Actual","Anticipated","2019-04-16","Anticipated","2018-10-01","2018-01-12","2018-01-22","2018-10-03","No","DNA damage repair\nreplication stress","Interventional","Treatment","Parallel Assignment","None (Open Label)","Non-Randomized","18 Years",null,"Female",null,"No","Yes\nLilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com. This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.",null,"URL: https://www.lillytrialguide.com/en-US/studies/ovarian-cancer/JTJN#?postal= [https://www.lillytrialguide.com/en-US/studies/ovarian-cancer/JTJN#?postal=] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: A Study of Prexasertib (LY2606368) in Platinum-Resistant or Refractory Recurrent Ovarian Cancer",null,"Yes","No",{"$nulls":17},"I4D-MC-JTJN|2017-004009-42","Eli Lilly and Company|EudraCT Number","Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR): Overall Response Rate (ORR)","Percentage of participants who achieve CR or PR: ORR","Baseline through Disease Progression (estimated at up to 12 months)","Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of Prexasertib|Disease Control Rate (DCR): Proportion of Participants with a Best Overall Response of CR, PR, or Stable Disease (SD) for at Least 4 Months|Duration of Response|Percentage of Participants with at Least a 50% Reduction in CA-125 Levels from Baseline|Progression-Free Survival|Overall Survival","PK: Cmax of prexasertib on day 1 of cycles 1, 2, 4 and 6|DCR: Percentage of participants with a best overall response of CR, PR, or SD for at least 4 months|Duration of response|Percentage of participants with at least a 50% reduction in CA-125 levels from baseline|Progression-free survival|Overall survival","Cycle 1 End of Infusion (Day 1) up to 1-2 Hours Following End of Infusion on Day 1 of Cycle 6 (each cycle is 28 days)|Baseline through Disease Progression (estimated at up to 12 months)|Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (estimated at up to 24 months)|Baseline, 4 Weeks|Baseline to Disease Progression or Death from any Cause (estimated at up to 12 months)|Baseline to Date of Death from Any Cause (estimated at up to 24 months)","Clinicaltrials.gov@lilly.com","There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or","1-317-615-4559","Bedford Park, South|Concord, New South Wales, Australia, 2139|Herston, Queensland, Australia, 4029|Melbourne, Victoria, Australia, 3000|Brussel, Belgium, 1000|Haifa, Israel, 3109601|Roma, Lazio, Italy, 00168|Milano, Lombardie, Italy, 20133|Milano, Milan, Italy, 20141|Napoli, Naples, Italy, 80131|Malaga, Andalucia, Spain, 29010|Barcelona, Spain, 08035|London, Greater London, United Kingdom, Nw1 2Bu|Manchester, Greater Manchester, United Kingdom, M20 4Bx|Northwood, Middlesex, United Kingdom, Ha6 2Rn|Glasgow, Scotland, United Kingdom, G12 0Yn|Guildford, Surrey, United Kingdom, Gu2 7Xx|Northampton, United Kingdom, Nn1 5Bd|Tucson, Arizona, United States, 85711|Sacramento, California, United States, 95817|Gainesville, Florida, United States, 32610-0296|Boston, Massachusetts, United States, 02215|Kansas City, Missouri, United States, 63142|Tulsa, Oklahoma, United States, 74146|Philadelphia, Pennsylvania, United States, 19107|Providence, Rhode Island, United States, 02903|Sioux Falls, South Dakota, United States, 57104|Knoxville, Tennessee, United States, 37920|Seattle, Washington, United States, 98109","Arizona|California|Florida|Massachusetts|Missouri|Oklahoma|Pennsylvania|Rhode Island|South Dakota|Tennessee|Washington","Australia|Belgium|Israel|Italy|Spain|United Kingdom|United States","Flinders Medical Centre|New South Wales Concord Repatriation General Hospital|Queensland Royal Brisbane And Womens Hospital|Victoria Peter Maccallum Cancer Centre|Institut Jules Bordet|Rambam Medical Center|Lazio Policlinico Univ. Agostino Gemelli|Lombardie Istituto Nazionale Dei Tumori|Milan Istituto Europeo Di Oncologia|Naples Istituto Tumori Fondazione G. Pascale Irccs|Andalucia Hospital Clinico Universitario Virgen De La Victoria|Hospital Universitari Vall D'Hebron|, Greater London University College Hospital - London|, Greater Manchester Christie Nhs Foundation Trust|, Middlesex Mount Vernon Hospital|, Scotland Beatson West Of Scotland Cancer Center|, Surrey Royal Surrey County Hospital|Northampton General Hospital|Arizona Oncology Associates, P.C.|University Of California, Davis - Health Systems|University Of Southern Florida School Of Medicine|Dana Farber Cancer Institute|Research Medical Center|Cancer Care Associates|Thomas Jefferson University|Rhode Island Hospital|Sioux Valley Clinic|University Of Tennessee Medical Center|Seattle Cancer Care Alliance",{"$nulls":3},"Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)","2018-10-03","2020-05-25T16:39:09.816","2020-05-26T17:10:42.972","NCT03414047"]
["5ecbf4aee2561b1b11905e89","NCT03414047","2018-10-23","Eli Lilly","LLY","Recruiting","A Study of Prexasertib (LY2606368) in Platinum-Resistant or Refractory Recurrent Ovarian Cancer","Prexasertib","CHK1 Inhibitor","Yes","['Prexasertib']","Yes","['CHK1 Inhibitor']","Phase 2",4,180,"Anticipated","2018-04-10","2019-04-16","RR|CR","Response Rate|Complete Response",{"$nulls":3},"The purpose of this study is to evaluate the efficacy and safety of prexasertib in women with platinum-resistant or refractory recurrent ovarian cancer.",null,"A Phase 2 Study of Prexasertib in Platinum-Resistant or Refractory Recurrent Ovarian Cancer",16712,"Ovarian Cancer","Ovarian Cancer","Oncology Solid Tumor","Oncology","Experimental","Prexasertib Cohort 1|Prexasertib Cohort 2|Prexasertib Cohort 3|Prexasertib Cohort 4","Participants with platinum-resistant disease that are breast cancer susceptibility gene (BRCA) negative and have received â‰¥3 lines of prior therapy.|Participants with platinum-resistant disease that are BRCA negative and have received <3 lines of prior therapy.|Participants with platinum-resistant disease that are BRCA positive and received a prior poly ADP ribose polymerase (PARP) inhibitor.|Participants with platinum refractory disease.","Drug","Prexasertib","Administered IV","LY2606368","Prexasertib Cohort 1|Prexasertib Cohort 2|Prexasertib Cohort 3|Prexasertib Cohort 4","\n\n * Women who have high-grade serous ovarian, primary peritoneal or fallopian tube cancer.\n * Cohorts 1 to 3: Have platinum-resistant disease and have documented test results assessing alterations in the BRCA1 and BRCA2 genes prior to receiving study treatment.\n * Cohort 1: Are BRCA negative and have received 3 or more prior lines of therapy.\n * Cohort 2: Are BRCA negative and have received less than 3 prior lines of therapy.\n * Cohort 3: Are BRCA positive and have previously received a PARP.\n * Cohort 4: Have primary platinum refractory disease.\n * Have adequate organ function.\n * Must be able and willing to undergo mandatory tumor biopsy.\n\n","\n\n * Cohorts 1-3: Have previously received all of the following agents at any time in the platinum-resistant setting: gemcitabine, pegylated liposomal doxorubicin, and paclitaxel.\n * Have known central nervous system malignancy or metastasis.\n * Have previously participated in any study involving a checkpoint kinase 1 inhibitor or have hypersensitivity to the study drug or excipients.\n * Have at least one of the following: * history of abdominal fistula or gastrointestinal perforation\n    * intra-abdominal abscess within last 3 months prior to the first dose of study drug\n    * a radiographically confirmed bowel obstruction within 3 months prior to the first dose of study drug\n   \n   \n * Have a symptomatic human immunodeficiency virus infection or symptomatic activated/reactivated hepatitis A, B, or C (screening is not required).\n * Have a serious cardiac condition.\n * Have a history of prior radiotherapy to the whole pelvis.\n * Have chronic daily treatment with corticosteroids, excluding inhaled or topical steroids.\n * Have known factors that may increase the risk of infection while on study drug treatment. These may include, but are not limited to, an indwelling peritoneal catheter or open wounds. Catheters for vascular access are permitted.","BRCA",null,"Protein","Breast","Actual","2018-01-29","Actual","Anticipated","2019-04-16","Anticipated","2018-10-17","2018-01-12","2018-01-22","2018-10-22","No","DNA damage repair\nreplication stress","Interventional","Treatment","Parallel Assignment","None (Open Label)","Non-Randomized","18 Years",null,"Female",null,"No","Yes\nLilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com. This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.",null,"URL: https://www.lillytrialguide.com/en-US/studies/ovarian-cancer/JTJN#?postal= [https://www.lillytrialguide.com/en-US/studies/ovarian-cancer/JTJN#?postal=] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: A Study of Prexasertib (LY2606368) in Platinum-Resistant or Refractory Recurrent Ovarian Cancer",null,"Yes","No",{"$nulls":17},"I4D-MC-JTJN|2017-004009-42","Eli Lilly and Company|EudraCT Number","Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR): Overall Response Rate (ORR)","Percentage of participants who achieve CR or PR: ORR","Baseline through Disease Progression (estimated at up to 12 months)","Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of Prexasertib|Disease Control Rate (DCR): Proportion of Participants with a Best Overall Response of CR, PR, or Stable Disease (SD) for at Least 4 Months|Duration of Response|Percentage of Participants with at Least a 50% Reduction in CA-125 Levels from Baseline|Progression-Free Survival|Overall Survival","PK: Cmax of prexasertib on day 1 of cycles 1, 2, 4 and 6|DCR: Percentage of participants with a best overall response of CR, PR, or SD for at least 4 months|Duration of response|Percentage of participants with at least a 50% reduction in CA-125 levels from baseline|Progression-free survival|Overall survival","Cycle 1 End of Infusion (Day 1) up to 1-2 Hours Following End of Infusion on Day 1 of Cycle 6 (each cycle is 28 days)|Baseline through Disease Progression (estimated at up to 12 months)|Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (estimated at up to 24 months)|Baseline, 4 Weeks|Baseline to Disease Progression or Death from any Cause (estimated at up to 12 months)|Baseline to Date of Death from Any Cause (estimated at up to 24 months)","Clinicaltrials.gov@lilly.com","There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or","1-317-615-4559","Bedford Park, South|Concord, New South Wales, Australia, 2139|Herston, Queensland, Australia, 4029|Melbourne, Victoria, Australia, 3000|Brussel, Belgium, 1000|Haifa, Israel, 3109601|Roma, Lazio, Italy, 00168|Milano, Lombardie, Italy, 20133|Milano, Milan, Italy, 20141|Napoli, Naples, Italy, 80131|Malaga, Andalucia, Spain, 29010|Barcelona, Spain, 08035|London, Greater London, United Kingdom, Nw1 2Bu|Manchester, Greater Manchester, United Kingdom, M20 4Bx|Northwood, Middlesex, United Kingdom, Ha6 2Rn|Glasgow, Scotland, United Kingdom, G12 0Yn|Guildford, Surrey, United Kingdom, Gu2 7Xx|Northampton, United Kingdom, Nn1 5Bd|Tucson, Arizona, United States, 85711|Sacramento, California, United States, 95817|Gainesville, Florida, United States, 32610-0296|Boston, Massachusetts, United States, 02215|Kansas City, Missouri, United States, 63142|Tulsa, Oklahoma, United States, 74146|Philadelphia, Pennsylvania, United States, 19107|Providence, Rhode Island, United States, 02903|Sioux Falls, South Dakota, United States, 57104|Knoxville, Tennessee, United States, 37920|Seattle, Washington, United States, 98109","Arizona|California|Florida|Massachusetts|Missouri|Oklahoma|Pennsylvania|Rhode Island|South Dakota|Tennessee|Washington","Australia|Belgium|Israel|Italy|Spain|United Kingdom|United States","Flinders Medical Centre|New South Wales Concord Repatriation General Hospital|Queensland Royal Brisbane And Womens Hospital|Victoria Peter Maccallum Cancer Centre|Institut Jules Bordet|Rambam Medical Center|Lazio Policlinico Univ. Agostino Gemelli|Lombardie Istituto Nazionale Dei Tumori|Milan Istituto Europeo Di Oncologia|Naples Istituto Tumori Fondazione G. Pascale Irccs|Andalucia Hospital Clinico Universitario Virgen De La Victoria|Hospital Universitari Vall D'Hebron|, Greater London University College Hospital - London|, Greater Manchester Christie Nhs Foundation Trust|, Middlesex Mount Vernon Hospital|, Scotland Beatson West Of Scotland Cancer Center|, Surrey Royal Surrey County Hospital|Northampton General Hospital|Arizona Oncology Associates, P.C.|University Of California, Davis - Health Systems|University Of Southern Florida School Of Medicine|Dana Farber Cancer Institute|Research Medical Center|Cancer Care Associates|Thomas Jefferson University|Rhode Island Hospital|Sioux Valley Clinic|University Of Tennessee Medical Center|Seattle Cancer Care Alliance",{"$nulls":3},"Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)","2018-10-22","2020-05-25T16:39:10.045","2020-05-26T17:10:42.972","NCT03414047"]
["5ecbf4ae307e3d1b1f8d9e22","NCT03414047","2019-01-24","Eli Lilly","LLY","Recruiting","A Study of Prexasertib (LY2606368) in Platinum-Resistant or Refractory Recurrent Ovarian Cancer","Prexasertib","CHK1 Inhibitor","Yes","['Prexasertib']","Yes","['CHK1 Inhibitor']","Phase 2",4,180,"Anticipated","2018-04-10","2019-04-16","RR|CR","Response Rate|Complete Response",{"$nulls":3},"The purpose of this study is to evaluate the efficacy and safety of prexasertib in women with platinum-resistant or refractory recurrent ovarian cancer.",null,"A Phase 2 Study of Prexasertib in Platinum-Resistant or Refractory Recurrent Ovarian Cancer",16712,"Ovarian Cancer","Ovarian Cancer","Oncology Solid Tumor","Oncology","Experimental","Prexasertib Cohort 1|Prexasertib Cohort 2|Prexasertib Cohort 3|Prexasertib Cohort 4","Participants with platinum-resistant disease that are breast cancer susceptibility gene (BRCA) negative and have received â‰¥3 lines of prior therapy.|Participants with platinum-resistant disease that are BRCA negative and have received <3 lines of prior therapy.|Participants with platinum-resistant disease that are BRCA positive and received a prior poly ADP ribose polymerase (PARP) inhibitor.|Participants with platinum refractory disease.","Drug","Prexasertib","Administered IV","LY2606368","Prexasertib Cohort 1|Prexasertib Cohort 2|Prexasertib Cohort 3|Prexasertib Cohort 4","\n\n * Women who have high-grade serous ovarian, primary peritoneal or fallopian tube cancer.\n * Cohorts 1 to 3: Have platinum-resistant disease and have documented test results assessing alterations in the BRCA1 and BRCA2 genes prior to receiving study treatment.\n * Cohort 1: Are BRCA negative and have received 3 or more prior lines of therapy.\n * Cohort 2: Are BRCA negative and have received less than 3 prior lines of therapy.\n * Cohort 3: Are BRCA positive and have previously received a PARP.\n * Cohort 4: Have primary platinum refractory disease.\n * Have adequate organ function.\n * Must be able and willing to undergo mandatory tumor biopsy.\n\n","\n\n * Cohorts 1-3: Have previously received all of the following agents at any time in the platinum-resistant setting: gemcitabine, pegylated liposomal doxorubicin, and paclitaxel.\n * Have known central nervous system malignancy or metastasis.\n * Have previously participated in any study involving a checkpoint kinase 1 inhibitor or have hypersensitivity to the study drug or excipients.\n * Have at least one of the following: * history of abdominal fistula or gastrointestinal perforation\n    * intra-abdominal abscess within last 3 months prior to the first dose of study drug\n    * a radiographically confirmed bowel obstruction within 3 months prior to the first dose of study drug\n   \n   \n * Have a symptomatic human immunodeficiency virus infection or symptomatic activated/reactivated hepatitis A, B, or C (screening is not required).\n * Have a serious cardiac condition.\n * Have a history of prior radiotherapy to the whole pelvis.\n * Have chronic daily treatment with corticosteroids, excluding inhaled or topical steroids.\n * Have known factors that may increase the risk of infection while on study drug treatment. These may include, but are not limited to, an indwelling peritoneal catheter or open wounds. Catheters for vascular access are permitted.","BRCA",null,"Protein","Breast","Actual","2018-01-29","Actual","Anticipated","2019-04-16","Anticipated","2019-01-01","2018-01-12","2018-01-22","2019-01-23","No","DNA damage repair\nreplication stress","Interventional","Treatment","Parallel Assignment","None (Open Label)","Non-Randomized","18 Years",null,"Female",null,"No","Yes\nLilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com. This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.",null,"URL: https://www.lillytrialguide.com/en-US/studies/ovarian-cancer/JTJN#?postal= [https://www.lillytrialguide.com/en-US/studies/ovarian-cancer/JTJN#?postal=] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: A Study of Prexasertib (LY2606368) in Platinum-Resistant or Refractory Recurrent Ovarian Cancer",null,"Yes","No",{"$nulls":17},"I4D-MC-JTJN|2017-004009-42","Eli Lilly and Company|EudraCT Number","Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR): Overall Response Rate (ORR)","Percentage of participants who achieve CR or PR: ORR","Baseline through Disease Progression (estimated at up to 12 months)","Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of Prexasertib|Disease Control Rate (DCR): Proportion of Participants with a Best Overall Response of CR, PR, or Stable Disease (SD) for at Least 4 Months|Duration of Response|Percentage of Participants with at Least a 50% Reduction in CA-125 Levels from Baseline|Progression-Free Survival|Overall Survival","PK: Cmax of prexasertib on day 1 of cycles 1, 2, 4 and 6|DCR: Percentage of participants with a best overall response of CR, PR, or SD for at least 4 months|Duration of response|Percentage of participants with at least a 50% reduction in CA-125 levels from baseline|Progression-free survival|Overall survival","Cycle 1 End of Infusion (Day 1) up to 1-2 Hours Following End of Infusion on Day 1 of Cycle 6 (each cycle is 28 days)|Baseline through Disease Progression (estimated at up to 12 months)|Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (estimated at up to 24 months)|Baseline, 4 Weeks|Baseline to Disease Progression or Death from any Cause (estimated at up to 12 months)|Baseline to Date of Death from Any Cause (estimated at up to 24 months)","Clinicaltrials.gov@lilly.com","There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or","1-317-615-4559","Bedford Park, South|Concord, New South Wales, Australia, 2139|Herston, Queensland, Australia, 4029|Melbourne, Victoria, Australia, 3000|Brussel, Belgium, 1000|Haifa, Israel, 3109601|Roma, Lazio, Italy, 00168|Milano, Lombardie, Italy, 20133|Milano, Milan, Italy, 20141|Napoli, Naples, Italy, 80131|Malaga, Andalucia, Spain, 29010|Barcelona, Spain, 08035|London, Greater London, United Kingdom, Nw1 2Bu|Manchester, Greater Manchester, United Kingdom, M20 4BxPrincipal Investigator: Jurjees Hasan|Northwood, Middlesex, United Kingdom, Ha6 2Rn|Glasgow, Scotland, United Kingdom, G12 0Yn|Guildford, Surrey, United Kingdom, Gu2 7Xx|Northampton, United Kingdom, Nn1 5Bd|Tucson, Arizona, United States, 85711|Vallejo, California, United States, 94589|Gainesville, Florida, United States, 32610-0296|Boston, Massachusetts, United States, 02215|Kansas City, Missouri, United States, 63142|Tulsa, Oklahoma, United States, 74146|Philadelphia, Pennsylvania, United States, 19107|Providence, Rhode Island, United States, 02903|Sioux Falls, South Dakota, United States, 57104|Knoxville, Tennessee, United States, 37920|Seattle, Washington, United States, 98109","Arizona|California|Florida|Massachusetts|Missouri|Oklahoma|Pennsylvania|Rhode Island|South Dakota|Tennessee|Washington","Australia|Belgium|Israel|Italy|Spain|United Kingdom|United States","Flinders Medical Centre|New South Wales Concord Repatriation General Hospital|Queensland Royal Brisbane And Womens Hospital|Victoria Peter Maccallum Cancer Centre|Institut Jules Bordet|Rambam Medical Center|Lazio Policlinico Univ. Agostino Gemelli|Lombardie Istituto Nazionale Dei Tumori|Milan Istituto Europeo Di Oncologia|Naples Istituto Tumori Fondazione G. Pascale Irccs|Andalucia Hospital Clinico Universitario Virgen De La Victoria|Hospital Universitari Vall D'Hebron|, Greater London University College Hospital - London|, Greater Manchester Christie Nhs Foundation Trust|, Middlesex Mount Vernon Hospital|, Scotland Beatson West Of Scotland Cancer Center|, Surrey Royal Surrey County Hospital|Northampton General Hospital|Arizona Oncology Associates, P.C.|Kaiser Permanente Medical Center|University Of Southern Florida School Of Medicine|Dana Farber Cancer Institute|Research Medical Center|Cancer Care Associates|Thomas Jefferson University|Rhode Island Hospital|Sioux Valley Clinic|University Of Tennessee Medical Center|Seattle Cancer Care Alliance",{"$nulls":3},"Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)","2019-01-23","2020-05-25T16:39:10.271","2020-05-26T17:10:42.972","NCT03414047"]
["5ecbf4ae11702c1b1b916b9c","NCT03414047","2019-03-05","Eli Lilly","LLY","Active, not recruiting","A Study of Prexasertib (LY2606368) in Platinum-Resistant or Refractory Recurrent Ovarian Cancer","Prexasertib","CHK1 Inhibitor","Yes","['Prexasertib']","Yes","['CHK1 Inhibitor']","Phase 2",4,180,"Anticipated","2018-04-10","2019-04-16","RR|CR","Response Rate|Complete Response",{"$nulls":3},"The purpose of this study is to evaluate the efficacy and safety of prexasertib in women with platinum-resistant or refractory recurrent ovarian cancer.",null,"A Phase 2 Study of Prexasertib in Platinum-Resistant or Refractory Recurrent Ovarian Cancer",16712,"Ovarian Cancer","Ovarian Cancer","Oncology Solid Tumor","Oncology","Experimental","Prexasertib Cohort 1|Prexasertib Cohort 2|Prexasertib Cohort 3|Prexasertib Cohort 4","Participants with platinum-resistant disease that are breast cancer susceptibility gene (BRCA) negative and have received â‰¥3 lines of prior therapy.|Participants with platinum-resistant disease that are BRCA negative and have received <3 lines of prior therapy.|Participants with platinum-resistant disease that are BRCA positive and received a prior poly ADP ribose polymerase (PARP) inhibitor.|Participants with platinum refractory disease.","Drug","Prexasertib","Administered IV","LY2606368","Prexasertib Cohort 1|Prexasertib Cohort 2|Prexasertib Cohort 3|Prexasertib Cohort 4","\n\n * Women who have high-grade serous ovarian, primary peritoneal or fallopian tube cancer.\n * Cohorts 1 to 3: Have platinum-resistant disease and have documented test results assessing alterations in the BRCA1 and BRCA2 genes prior to receiving study treatment.\n * Cohort 1: Are BRCA negative and have received 3 or more prior lines of therapy.\n * Cohort 2: Are BRCA negative and have received less than 3 prior lines of therapy.\n * Cohort 3: Are BRCA positive and have previously received a PARP.\n * Cohort 4: Have primary platinum refractory disease.\n * Have adequate organ function.\n * Must be able and willing to undergo mandatory tumor biopsy.\n\n","\n\n * Cohorts 1-3: Have previously received all of the following agents at any time in the platinum-resistant setting: gemcitabine, pegylated liposomal doxorubicin, and paclitaxel.\n * Have known central nervous system malignancy or metastasis.\n * Have previously participated in any study involving a checkpoint kinase 1 inhibitor or have hypersensitivity to the study drug or excipients.\n * Have at least one of the following: * history of abdominal fistula or gastrointestinal perforation\n    * intra-abdominal abscess within last 3 months prior to the first dose of study drug\n    * a radiographically confirmed bowel obstruction within 3 months prior to the first dose of study drug\n   \n   \n * Have a symptomatic human immunodeficiency virus infection or symptomatic activated/reactivated hepatitis A, B, or C (screening is not required).\n * Have a serious cardiac condition.\n * Have a history of prior radiotherapy to the whole pelvis.\n * Have chronic daily treatment with corticosteroids, excluding inhaled or topical steroids.\n * Have known factors that may increase the risk of infection while on study drug treatment. These may include, but are not limited to, an indwelling peritoneal catheter or open wounds. Catheters for vascular access are permitted.","BRCA",null,"Protein","Breast","Actual","2018-01-29","Actual","Anticipated","2019-04-16","Anticipated","2019-03-01","2018-01-12","2018-01-22","2019-03-04","No","DNA damage repair\nreplication stress","Interventional","Treatment","Parallel Assignment","None (Open Label)","Non-Randomized","18 Years",null,"Female",null,"No","Yes\nLilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com. This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.",null,"URL: https://www.lillytrialguide.com/en-US/studies/ovarian-cancer/JTJN#?postal= [https://www.lillytrialguide.com/en-US/studies/ovarian-cancer/JTJN#?postal=] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: A Study of Prexasertib (LY2606368) in Platinum-Resistant or Refractory Recurrent Ovarian Cancer",null,"Yes","No",{"$nulls":17},"I4D-MC-JTJN|2017-004009-42","Eli Lilly and Company|EudraCT Number","Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR): Overall Response Rate (ORR)","Percentage of participants who achieve CR or PR: ORR","Baseline through Disease Progression (estimated at up to 12 months)","Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of Prexasertib|Disease Control Rate (DCR): Proportion of Participants with a Best Overall Response of CR, PR, or Stable Disease (SD) for at Least 4 Months|Duration of Response|Percentage of Participants with at Least a 50% Reduction in CA-125 Levels from Baseline|Progression-Free Survival|Overall Survival","PK: Cmax of prexasertib on day 1 of cycles 1, 2, 4 and 6|DCR: Percentage of participants with a best overall response of CR, PR, or SD for at least 4 months|Duration of response|Percentage of participants with at least a 50% reduction in CA-125 levels from baseline|Progression-free survival|Overall survival","Cycle 1 End of Infusion (Day 1) up to 1-2 Hours Following End of Infusion on Day 1 of Cycle 6 (each cycle is 28 days)|Baseline through Disease Progression (estimated at up to 12 months)|Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (estimated at up to 24 months)|Baseline, 4 Weeks|Baseline to Disease Progression or Death from any Cause (estimated at up to 12 months)|Baseline to Date of Death from Any Cause (estimated at up to 24 months)",{"$nulls":3},"Toorak Gardens, South|Bedford Park, South|Concord, New South Wales, Australia, 2139 Prince Of Wales HospitalRandwick, New South Wales, Australia, 2031 Westmead HospitalWentworthville, New South Wales, Australia, 2145|Herston, Queensland, Australia, 4029 Mater Adult Hospital BrisbaneSouth Brisbane, Queensland, Australia, 4101|Melbourne, Victoria, Australia, 3000|Brussel, Belgium, 1000 Universitaire Ziekenhuizen Leuven - Campus GasthuisbergLeuven, Belgium, 3000 Gza St AugustinusWilrijk, Belgium, 2610|Haifa, Israel, 3109601 Shaare Zedek Medical CenterJerusalem, Israel, 9103102 Sheba Medical CenterRamat Gan, Israel, 5265601|Roma, Lazio, Italy, 00168|Milano, Lombardie, Italy, 20133|Milano, Milan, Italy, 20141|Napoli, Naples, Italy, 80131 Korea, Republic Of, Korea Samsung Medical CenterSeoul, Korea, Korea, Republic Of, 06351 Korea, Republic Of Seoul National University HospitalSeoul, Korea, Republic Of, 03080 Asan Medical CenterSeoul, Korea, Republic Of, 05505 Severance Hospital Yonsei University Health SystemSeoul, Korea, Republic Of, 120-792|Malaga, Andalucia, Spain, 29010|Barcelona, Spain, 08035 Hospital De La Santa Creu I Sant PauBarcelona, Spain, 08041 Hospital Reina SofiaCordoba, Spain, 14004 Hospital Universitario Ramon Y CajalMadrid, Spain, 28034 Hospital Universitario 12 De OctubreMadrid, Spain, 28041 Hospital Universitario La PazMadrid, Spain, 28046|London, Greater London, United Kingdom, Nw1 2Bu|Manchester, Greater Manchester, United Kingdom, M20 4Bx|Northwood, Middlesex, United Kingdom, Ha6 2Rn|Glasgow, Scotland, United Kingdom, G12 0Yn|Guildford, Surrey, United Kingdom, Gu2 7Xx Royal Marsden HospitalSutton, Surrey, United Kingdom, Sm2 5Pt|Northampton, United Kingdom, Nn1 5Bd|Tucson, Arizona, United States, 85711|Vallejo, California, United States, 94589|Gainesville, Florida, United States, 32610-0296 Sarasota Memorial HospitalSarasota, Florida, United States, 34239-3555|Boston, Massachusetts, United States, 02215|Kansas City, Missouri, United States, 63142|Tulsa, Oklahoma, United States, 74146|Philadelphia, Pennsylvania, United States, 19107|Providence, Rhode Island, United States, 02903|Sioux Falls, South Dakota, United States, 57104|Knoxville, Tennessee, United States, 37920 Sarah Cannon Research Institute ScriNashville, Tennessee, United States, 37203 Tennessee Oncology PllcNashville, Tennessee, United States, 37203|Seattle, Washington, United States, 98109","Arizona|California|Florida|Massachusetts|Missouri|Oklahoma|Pennsylvania|Rhode Island|South Dakota|Tennessee|Washington","Australia|Belgium|Israel|Italy|Spain|United Kingdom|United States","Australia, 5042 Burnside War Memorial Hospital|Flinders Medical Centre|New South Wales Concord Repatriation General Hospital|Queensland Royal Brisbane And Womens Hospital|Victoria Peter Maccallum Cancer Centre|Institut Jules Bordet|Rambam Medical Center|Lazio Policlinico Univ. Agostino Gemelli|Lombardie Istituto Nazionale Dei Tumori|Milan Istituto Europeo Di Oncologia|Naples Istituto Tumori Fondazione G. Pascale Irccs|Andalucia Hospital Clinico Universitario Virgen De La Victoria|Hospital Universitari Vall D'Hebron|, Greater London University College Hospital - London|, Greater Manchester Christie Nhs Foundation Trust|, Middlesex Mount Vernon Hospital|, Scotland Beatson West Of Scotland Cancer Center|, Surrey Royal Surrey County Hospital|Northampton General Hospital|Arizona Oncology Associates, P.C.|Kaiser Permanente Medical Center|University Of Southern Florida School Of Medicine|Dana Farber Cancer Institute|Research Medical Center|Cancer Care Associates|Thomas Jefferson University|Rhode Island Hospital|Sioux Valley Clinic|University Of Tennessee Medical Center|Seattle Cancer Care Alliance",{"$nulls":3},"Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)","2019-03-04","2020-05-25T16:39:10.065","2020-05-26T17:10:42.972","NCT03414047"]
["5ecbf4aefe30261b1a048390","NCT03414047","2019-03-19","Eli Lilly","LLY","Active, not recruiting","A Study of Prexasertib (LY2606368) in Platinum-Resistant or Refractory Recurrent Ovarian Cancer","Prexasertib","CHK1 Inhibitor","Yes","['Prexasertib']","Yes","['CHK1 Inhibitor']","Phase 2",4,173,"Actual","2018-04-10","2019-04-16","RR|CR","Response Rate|Complete Response",{"$nulls":3},"The purpose of this study is to evaluate the efficacy and safety of prexasertib in women with platinum-resistant or refractory recurrent ovarian cancer.",null,"A Phase 2 Study of Prexasertib in Platinum-Resistant or Refractory Recurrent Ovarian Cancer",16712,"Ovarian Cancer","Ovarian Cancer","Oncology Solid Tumor","Oncology","Experimental","Prexasertib Cohort 1|Prexasertib Cohort 2|Prexasertib Cohort 3|Prexasertib Cohort 4","Participants with platinum-resistant disease that are breast cancer susceptibility gene (BRCA) negative and have received â‰¥3 lines of prior therapy.|Participants with platinum-resistant disease that are BRCA negative and have received <3 lines of prior therapy.|Participants with platinum-resistant disease that are BRCA positive and received a prior poly ADP ribose polymerase (PARP) inhibitor.|Participants with platinum refractory disease.","Drug","Prexasertib","Administered IV","LY2606368","Prexasertib Cohort 1|Prexasertib Cohort 2|Prexasertib Cohort 3|Prexasertib Cohort 4","\n\n * Women who have high-grade serous ovarian, primary peritoneal or fallopian tube cancer.\n * Cohorts 1 to 3: Have platinum-resistant disease and have documented test results assessing alterations in the BRCA1 and BRCA2 genes prior to receiving study treatment.\n * Cohort 1: Are BRCA negative and have received 3 or more prior lines of therapy.\n * Cohort 2: Are BRCA negative and have received less than 3 prior lines of therapy.\n * Cohort 3: Are BRCA positive and have previously received a PARP.\n * Cohort 4: Have primary platinum refractory disease.\n * Have adequate organ function.\n * Must be able and willing to undergo mandatory tumor biopsy.\n\n","\n\n * Cohorts 1-3: Have previously received all of the following agents at any time in the platinum-resistant setting: gemcitabine, pegylated liposomal doxorubicin, and paclitaxel.\n * Have known central nervous system malignancy or metastasis.\n * Have previously participated in any study involving a checkpoint kinase 1 inhibitor or have hypersensitivity to the study drug or excipients.\n * Have at least one of the following: * history of abdominal fistula or gastrointestinal perforation\n    * intra-abdominal abscess within last 3 months prior to the first dose of study drug\n    * a radiographically confirmed bowel obstruction within 3 months prior to the first dose of study drug\n   \n   \n * Have a symptomatic human immunodeficiency virus infection or symptomatic activated/reactivated hepatitis A, B, or C (screening is not required).\n * Have a serious cardiac condition.\n * Have a history of prior radiotherapy to the whole pelvis.\n * Have chronic daily treatment with corticosteroids, excluding inhaled or topical steroids.\n * Have known factors that may increase the risk of infection while on study drug treatment. These may include, but are not limited to, an indwelling peritoneal catheter or open wounds. Catheters for vascular access are permitted.","BRCA",null,"Protein","Breast","Actual","2018-01-29","Actual","Anticipated","2019-04-16","Anticipated","2019-03-01","2018-01-12","2018-01-22","2019-03-18","No","DNA damage repair\nreplication stress","Interventional","Treatment","Parallel Assignment","None (Open Label)","Non-Randomized","18 Years",null,"Female",null,"No","Yes\nLilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com. This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.",null,"URL: https://www.lillytrialguide.com/en-US/studies/ovarian-cancer/JTJN#?postal= [https://www.lillytrialguide.com/en-US/studies/ovarian-cancer/JTJN#?postal=] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: A Study of Prexasertib (LY2606368) in Platinum-Resistant or Refractory Recurrent Ovarian Cancer",null,"Yes","No",{"$nulls":17},"I4D-MC-JTJN|2017-004009-42","Eli Lilly and Company|EudraCT Number","Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR): Overall Response Rate (ORR)","Percentage of participants who achieve CR or PR: ORR","Baseline through Disease Progression (estimated at up to 12 months)","Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of Prexasertib|Disease Control Rate (DCR): Proportion of Participants with a Best Overall Response of CR, PR, or Stable Disease (SD) for at Least 4 Months|Duration of Response|Percentage of Participants with at Least a 50% Reduction in CA-125 Levels from Baseline|Progression-Free Survival|Overall Survival","PK: Cmax of prexasertib on day 1 of cycles 1, 2, 4 and 6|DCR: Percentage of participants with a best overall response of CR, PR, or SD for at least 4 months|Duration of response|Percentage of participants with at least a 50% reduction in CA-125 levels from baseline|Progression-free survival|Overall survival","Cycle 1 End of Infusion (Day 1) up to 1-2 Hours Following End of Infusion on Day 1 of Cycle 6 (each cycle is 28 days)|Baseline through Disease Progression (estimated at up to 12 months)|Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (estimated at up to 24 months)|Baseline, 4 Weeks|Baseline to Disease Progression or Death from any Cause (estimated at up to 12 months)|Baseline to Date of Death from Any Cause (estimated at up to 24 months)",{"$nulls":3},"Toorak Gardens, South|Bedford Park, South|Concord, New South Wales, Australia, 2139 Prince Of Wales HospitalRandwick, New South Wales, Australia, 2031 Westmead HospitalWentworthville, New South Wales, Australia, 2145|Herston, Queensland, Australia, 4029 Mater Adult Hospital BrisbaneSouth Brisbane, Queensland, Australia, 4101|Melbourne, Victoria, Australia, 3000|Brussel, Belgium, 1000 Universitaire Ziekenhuizen Leuven - Campus GasthuisbergLeuven, Belgium, 3000 Gza St AugustinusWilrijk, Belgium, 2610|Haifa, Israel, 3109601 Shaare Zedek Medical CenterJerusalem, Israel, 9103102 Sheba Medical CenterRamat Gan, Israel, 5265601|Roma, Lazio, Italy, 00168|Milano, Lombardie, Italy, 20133|Milano, Milan, Italy, 20141|Napoli, Naples, Italy, 80131 Korea, Republic Of, Korea Samsung Medical CenterSeoul, Korea, Korea, Republic Of, 06351 Korea, Republic Of Seoul National University HospitalSeoul, Korea, Republic Of, 03080 Asan Medical CenterSeoul, Korea, Republic Of, 05505 Severance Hospital Yonsei University Health SystemSeoul, Korea, Republic Of, 120-792|Barcelona, Spain, 08035 Hospital Reina SofiaCordoba, Spain, 14004 Hospital Universitario Ramon Y CajalMadrid, Spain, 28034 Hospital Universitario 12 De OctubreMadrid, Spain, 28041 Hospital Universitario La PazMadrid, Spain, 28046|London, Greater London, United Kingdom, Nw1 2Bu|Manchester, Greater Manchester, United Kingdom, M20 4Bx|Northwood, Middlesex, United Kingdom, Ha6 2Rn|Guildford, Surrey, United Kingdom, Gu2 7Xx Royal Marsden HospitalSutton, Surrey, United Kingdom, Sm2 5Pt|Northampton, United Kingdom, Nn1 5Bd|Tucson, Arizona, United States, 85711|Vallejo, California, United States, 94589|Gainesville, Florida, United States, 32610-0296 Sarasota Memorial HospitalSarasota, Florida, United States, 34239-3555|Boston, Massachusetts, United States, 02215|Kansas City, Missouri, United States, 63142|Tulsa, Oklahoma, United States, 74146|Philadelphia, Pennsylvania, United States, 19107|Providence, Rhode Island, United States, 02903|Sioux Falls, South Dakota, United States, 57104|Knoxville, Tennessee, United States, 37920 Sarah Cannon Research Institute ScriNashville, Tennessee, United States, 37203 Tennessee Oncology PllcNashville, Tennessee, United States, 37203|Seattle, Washington, United States, 98109","Arizona|California|Florida|Massachusetts|Missouri|Oklahoma|Pennsylvania|Rhode Island|South Dakota|Tennessee|Washington","Australia|Belgium|Israel|Italy|Spain|United Kingdom|United States","Australia, 5042 Burnside War Memorial Hospital|Flinders Medical Centre|New South Wales Concord Repatriation General Hospital|Queensland Royal Brisbane And Womens Hospital|Victoria Peter Maccallum Cancer Centre|Institut Jules Bordet|Rambam Medical Center|Lazio Policlinico Univ. Agostino Gemelli|Lombardie Istituto Nazionale Dei Tumori|Milan Istituto Europeo Di Oncologia|Naples Istituto Tumori Fondazione G. Pascale Irccs|Hospital Universitari Vall D'Hebron|, Greater London University College Hospital - London|, Greater Manchester Christie Nhs Foundation Trust|, Middlesex Mount Vernon Hospital|, Surrey Royal Surrey County Hospital|Northampton General Hospital|Arizona Oncology Associates, P.C.|Kaiser Permanente Medical Center|University Of Southern Florida School Of Medicine|Dana Farber Cancer Institute|Research Medical Center|Cancer Care Associates|Thomas Jefferson University|Rhode Island Hospital|Sioux Valley Clinic|University Of Tennessee Medical Center|Seattle Cancer Care Alliance",{"$nulls":3},"Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)","2019-03-18","2020-05-25T16:39:10.221","2020-05-26T17:10:42.972","NCT03414047"]
["5ecbf4aefeab101b155309bf","NCT03414047","2019-05-03","Eli Lilly","LLY","Active, not recruiting","A Study of Prexasertib (LY2606368) in Platinum-Resistant or Refractory Recurrent Ovarian Cancer","Prexasertib","CHK1 Inhibitor","Yes","['Prexasertib']","Yes","['CHK1 Inhibitor']","Phase 2",4,173,"Actual","2018-04-10","2019-05-31","RR|CR","Response Rate|Complete Response",{"$nulls":3},"The purpose of this study is to evaluate the efficacy and safety of prexasertib in women with platinum-resistant or refractory recurrent ovarian cancer.",null,"A Phase 2 Study of Prexasertib in Platinum-Resistant or Refractory Recurrent Ovarian Cancer",16712,"Ovarian Cancer","Ovarian Cancer","Oncology Solid Tumor","Oncology","Experimental","Prexasertib Cohort 1|Prexasertib Cohort 2|Prexasertib Cohort 3|Prexasertib Cohort 4","Participants with platinum-resistant disease that are breast cancer susceptibility gene (BRCA) negative and have received â‰¥3 lines of prior therapy.|Participants with platinum-resistant disease that are BRCA negative and have received <3 lines of prior therapy.|Participants with platinum-resistant disease that are BRCA positive and received a prior poly ADP ribose polymerase (PARP) inhibitor.|Participants with platinum refractory disease.","Drug","Prexasertib","Administered IV","LY2606368","Prexasertib Cohort 1|Prexasertib Cohort 2|Prexasertib Cohort 3|Prexasertib Cohort 4","\n\n * Women who have high-grade serous ovarian, primary peritoneal or fallopian tube cancer.\n * Cohorts 1 to 3: Have platinum-resistant disease and have documented test results assessing alterations in the BRCA1 and BRCA2 genes prior to receiving study treatment.\n * Cohort 1: Are BRCA negative and have received 3 or more prior lines of therapy.\n * Cohort 2: Are BRCA negative and have received less than 3 prior lines of therapy.\n * Cohort 3: Are BRCA positive and have previously received a PARP.\n * Cohort 4: Have primary platinum refractory disease.\n * Have adequate organ function.\n * Must be able and willing to undergo mandatory tumor biopsy.\n\n","\n\n * Cohorts 1-3: Have previously received all of the following agents at any time in the platinum-resistant setting: gemcitabine, pegylated liposomal doxorubicin, and paclitaxel.\n * Have known central nervous system malignancy or metastasis.\n * Have previously participated in any study involving a checkpoint kinase 1 inhibitor or have hypersensitivity to the study drug or excipients.\n * Have at least one of the following: * history of abdominal fistula or gastrointestinal perforation\n    * intra-abdominal abscess within last 3 months prior to the first dose of study drug\n    * a radiographically confirmed bowel obstruction within 3 months prior to the first dose of study drug\n   \n   \n * Have a symptomatic human immunodeficiency virus infection or symptomatic activated/reactivated hepatitis A, B, or C (screening is not required).\n * Have a serious cardiac condition.\n * Have a history of prior radiotherapy to the whole pelvis.\n * Have chronic daily treatment with corticosteroids, excluding inhaled or topical steroids.\n * Have known factors that may increase the risk of infection while on study drug treatment. These may include, but are not limited to, an indwelling peritoneal catheter or open wounds. Catheters for vascular access are permitted.","BRCA",null,"Protein","Breast","Actual","2018-01-29","Actual","Anticipated","2019-12-31","Anticipated","2019-05-01","2018-01-12","2018-01-22","2019-05-02","No","DNA damage repair\nreplication stress","Interventional","Treatment","Parallel Assignment","None (Open Label)","Non-Randomized","18 Years",null,"Female",null,"No","Yes\nLilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com. This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.",null,"URL: https://www.lillytrialguide.com/en-US/studies/ovarian-cancer/JTJN#?postal= [https://www.lillytrialguide.com/en-US/studies/ovarian-cancer/JTJN#?postal=] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: A Study of Prexasertib (LY2606368) in Platinum-Resistant or Refractory Recurrent Ovarian Cancer",null,"Yes","No",{"$nulls":17},"I4D-MC-JTJN|2017-004009-42","Eli Lilly and Company|EudraCT Number","Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR): Overall Response Rate (ORR)","Percentage of participants who achieve CR or PR: ORR","Baseline through Disease Progression (estimated at up to 12 months)","Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of Prexasertib|Disease Control Rate (DCR): Proportion of Participants with a Best Overall Response of CR, PR, or Stable Disease (SD) for at Least 4 Months|Duration of Response|Percentage of Participants with at Least a 50% Reduction in CA-125 Levels from Baseline|Progression-Free Survival|Overall Survival","PK: Cmax of prexasertib on day 1 of cycles 1, 2, 4 and 6|DCR: Percentage of participants with a best overall response of CR, PR, or SD for at least 4 months|Duration of response|Percentage of participants with at least a 50% reduction in CA-125 levels from baseline|Progression-free survival|Overall survival","Cycle 1 End of Infusion (Day 1) up to 1-2 Hours Following End of Infusion on Day 1 of Cycle 6 (each cycle is 28 days)|Baseline through Disease Progression (estimated at up to 12 months)|Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (estimated at up to 24 months)|Baseline, 4 Weeks|Baseline to Disease Progression or Death from any Cause (estimated at up to 12 months)|Baseline to Date of Death from Any Cause (estimated at up to 24 months)",{"$nulls":3},"Toorak Gardens, South|Bedford Park, South|Concord, New South Wales, Australia, 2139 Prince Of Wales HospitalRandwick, New South Wales, Australia, 2031 Westmead HospitalWentworthville, New South Wales, Australia, 2145|Herston, Queensland, Australia, 4029 Mater Adult Hospital BrisbaneSouth Brisbane, Queensland, Australia, 4101|Melbourne, Victoria, Australia, 3000|Brussel, Belgium, 1000 Universitaire Ziekenhuizen Leuven - Campus GasthuisbergLeuven, Belgium, 3000 Gza St AugustinusWilrijk, Belgium, 2610|Haifa, Israel, 3109601 Shaare Zedek Medical CenterJerusalem, Israel, 9103102 Sheba Medical CenterRamat Gan, Israel, 5265601|Roma, Lazio, Italy, 00168|Milano, Milan, Italy, 20141|Napoli, Naples, Italy, 80131 Korea, Republic Of, Korea Samsung Medical CenterSeoul, Korea, Korea, Republic Of, 06351 Korea, Republic Of Seoul National University HospitalSeoul, Korea, Republic Of, 03080 Asan Medical CenterSeoul, Korea, Republic Of, 05505 Severance Hospital Yonsei University Health SystemSeoul, Korea, Republic Of, 120-792|Barcelona, Spain, 08035 Hospital Reina SofiaCordoba, Spain, 14004 Hospital Universitario Ramon Y CajalMadrid, Spain, 28034 Hospital Universitario 12 De OctubreMadrid, Spain, 28041 Hospital Universitario La PazMadrid, Spain, 28046|London, Greater London, United Kingdom, Nw1 2Bu|Manchester, Greater Manchester, United Kingdom, M20 4Bx|Northwood, Middlesex, United Kingdom, Ha6 2Rn|Guildford, Surrey, United Kingdom, Gu2 7Xx Royal Marsden HospitalSutton, Surrey, United Kingdom, Sm2 5Pt|Northampton, United Kingdom, Nn1 5Bd|Tucson, Arizona, United States, 85711|Vallejo, California, United States, 94589|Gainesville, Florida, United States, 32610-0296|Boston, Massachusetts, United States, 02215|Kansas City, Missouri, United States, 63142|Tulsa, Oklahoma, United States, 74146|Philadelphia, Pennsylvania, United States, 19107|Providence, Rhode Island, United States, 02903|Sioux Falls, South Dakota, United States, 57104|Knoxville, Tennessee, United States, 37920 Sarah Cannon Research Institute ScriNashville, Tennessee, United States, 37203 Tennessee Oncology PllcNashville, Tennessee, United States, 37203|Seattle, Washington, United States, 98109","Arizona|California|Florida|Massachusetts|Missouri|Oklahoma|Pennsylvania|Rhode Island|South Dakota|Tennessee|Washington","Australia|Belgium|Israel|Italy|Spain|United Kingdom|United States","Australia, 5042 Burnside War Memorial Hospital|Flinders Medical Centre|New South Wales Concord Repatriation General Hospital|Queensland Royal Brisbane And Womens Hospital|Victoria Peter Maccallum Cancer Centre|Institut Jules Bordet|Rambam Medical Center|Lazio Policlinico Univ. Agostino Gemelli|Milan Istituto Europeo Di Oncologia|Naples Istituto Tumori Fondazione G. Pascale Irccs|Hospital Universitari Vall D'Hebron|, Greater London University College Hospital - London|, Greater Manchester Christie Nhs Foundation Trust|, Middlesex Mount Vernon Hospital|, Surrey Royal Surrey County Hospital|Northampton General Hospital|Arizona Oncology Associates, P.C.|Kaiser Permanente Medical Center|University Of Southern Florida School Of Medicine|Dana Farber Cancer Institute|Research Medical Center|Cancer Care Associates|Thomas Jefferson University|Rhode Island Hospital|Sioux Valley Clinic|University Of Tennessee Medical Center|Seattle Cancer Care Alliance",{"$nulls":3},"Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)","2019-05-02","2020-05-25T16:39:10.482","2020-05-26T17:10:42.972","NCT03414047"]
["5ecbf4aee2561b1b11905e8a","NCT03414047","2019-06-18","Eli Lilly","LLY","Active, not recruiting","A Study of Prexasertib (LY2606368) in Platinum-Resistant or Refractory Recurrent Ovarian Cancer","Prexasertib","CHK1 Inhibitor","Yes","['Prexasertib']","Yes","['CHK1 Inhibitor']","Phase 2",4,173,"Actual","2018-04-10","2019-06-03","RR|CR","Response Rate|Complete Response",{"$nulls":3},"The purpose of this study is to evaluate the efficacy and safety of prexasertib in women with platinum-resistant or refractory recurrent ovarian cancer.",null,"A Phase 2 Study of Prexasertib in Platinum-Resistant or Refractory Recurrent Ovarian Cancer",16712,"Ovarian Cancer","Ovarian Cancer","Oncology Solid Tumor","Oncology","Experimental","Prexasertib Cohort 1|Prexasertib Cohort 2|Prexasertib Cohort 3|Prexasertib Cohort 4","Participants with platinum-resistant disease that are breast cancer susceptibility gene (BRCA) negative and have received â‰¥3 lines of prior therapy.|Participants with platinum-resistant disease that are BRCA negative and have received <3 lines of prior therapy.|Participants with platinum-resistant disease that are BRCA positive and received a prior poly ADP ribose polymerase (PARP) inhibitor.|Participants with platinum refractory disease.","Drug","Prexasertib","Administered IV","LY2606368","Prexasertib Cohort 1|Prexasertib Cohort 2|Prexasertib Cohort 3|Prexasertib Cohort 4","\n\n * Women who have high-grade serous ovarian, primary peritoneal or fallopian tube cancer.\n * Cohorts 1 to 3: Have platinum-resistant disease and have documented test results assessing alterations in the BRCA1 and BRCA2 genes prior to receiving study treatment.\n * Cohort 1: Are BRCA negative and have received 3 or more prior lines of therapy.\n * Cohort 2: Are BRCA negative and have received less than 3 prior lines of therapy.\n * Cohort 3: Are BRCA positive and have previously received a PARP.\n * Cohort 4: Have primary platinum refractory disease.\n * Have adequate organ function.\n * Must be able and willing to undergo mandatory tumor biopsy.\n\n","\n\n * Cohorts 1-3: Have previously received all of the following agents at any time in the platinum-resistant setting: gemcitabine, pegylated liposomal doxorubicin, and paclitaxel.\n * Have known central nervous system malignancy or metastasis.\n * Have previously participated in any study involving a checkpoint kinase 1 inhibitor or have hypersensitivity to the study drug or excipients.\n * Have at least one of the following: * history of abdominal fistula or gastrointestinal perforation\n    * intra-abdominal abscess within last 3 months prior to the first dose of study drug\n    * a radiographically confirmed bowel obstruction within 3 months prior to the first dose of study drug\n   \n   \n * Have a symptomatic human immunodeficiency virus infection or symptomatic activated/reactivated hepatitis A, B, or C (screening is not required).\n * Have a serious cardiac condition.\n * Have a history of prior radiotherapy to the whole pelvis.\n * Have chronic daily treatment with corticosteroids, excluding inhaled or topical steroids.\n * Have known factors that may increase the risk of infection while on study drug treatment. These may include, but are not limited to, an indwelling peritoneal catheter or open wounds. Catheters for vascular access are permitted.","BRCA",null,"Protein","Breast","Actual","2018-01-29","Actual","Actual","2019-12-31","Anticipated","2019-06-01","2018-01-12","2018-01-22","2019-06-17","No","DNA damage repair\nreplication stress","Interventional","Treatment","Parallel Assignment","None (Open Label)","Non-Randomized","18 Years",null,"Female",null,"No","Yes\nLilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com. This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.",null,"URL: https://www.lillytrialguide.com/en-US/studies/ovarian-cancer/JTJN#?postal= [https://www.lillytrialguide.com/en-US/studies/ovarian-cancer/JTJN#?postal=] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: A Study of Prexasertib (LY2606368) in Platinum-Resistant or Refractory Recurrent Ovarian Cancer",null,"Yes","No",{"$nulls":17},"I4D-MC-JTJN|2017-004009-42","Eli Lilly and Company|EudraCT Number","Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR): Overall Response Rate (ORR)","Percentage of participants who achieve CR or PR: ORR","Baseline through Disease Progression (estimated at up to 12 months)","Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of Prexasertib|Disease Control Rate (DCR): Proportion of Participants with a Best Overall Response of CR, PR, or Stable Disease (SD) for at Least 4 Months|Duration of Response|Percentage of Participants with at Least a 50% Reduction in CA-125 Levels from Baseline|Progression-Free Survival|Overall Survival","PK: Cmax of prexasertib on day 1 of cycles 1, 2, 4 and 6|DCR: Percentage of participants with a best overall response of CR, PR, or SD for at least 4 months|Duration of response|Percentage of participants with at least a 50% reduction in CA-125 levels from baseline|Progression-free survival|Overall survival","Cycle 1 End of Infusion (Day 1) up to 1-2 Hours Following End of Infusion on Day 1 of Cycle 6 (each cycle is 28 days)|Baseline through Disease Progression (estimated at up to 12 months)|Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (estimated at up to 24 months)|Baseline, 4 Weeks|Baseline to Disease Progression or Death from any Cause (estimated at up to 12 months)|Baseline to Date of Death from Any Cause (estimated at up to 24 months)",{"$nulls":3},"Toorak Gardens, South|Bedford Park, South|Concord, New South Wales, Australia, 2139 Prince Of Wales HospitalRandwick, New South Wales, Australia, 2031 Westmead HospitalWentworthville, New South Wales, Australia, 2145|Herston, Queensland, Australia, 4029 Mater Adult Hospital BrisbaneSouth Brisbane, Queensland, Australia, 4101|Melbourne, Victoria, Australia, 3000|Brussel, Belgium, 1000 Universitaire Ziekenhuizen Leuven - Campus GasthuisbergLeuven, Belgium, 3000 Gza St AugustinusWilrijk, Belgium, 2610|Haifa, Israel, 3109601 Shaare Zedek Medical CenterJerusalem, Israel, 9103102 Sheba Medical CenterRamat Gan, Israel, 5265601|Roma, Lazio, Italy, 00168|Milano, Milan, Italy, 20141|Napoli, Naples, Italy, 80131 Korea, Republic Of, Korea Samsung Medical CenterSeoul, Korea, Korea, Republic Of, 06351 Korea, Republic Of Seoul National University HospitalSeoul, Korea, Republic Of, 03080 Asan Medical CenterSeoul, Korea, Republic Of, 05505 Severance Hospital Yonsei University Health SystemSeoul, Korea, Republic Of, 120-792|Barcelona, Spain, 08035 Hospital Reina SofiaCordoba, Spain, 14004 Hospital Universitario Ramon Y CajalMadrid, Spain, 28034 Hospital Universitario 12 De OctubreMadrid, Spain, 28041 Hospital Universitario La PazMadrid, Spain, 28046|London, Greater London, United Kingdom, Nw1 2Bu|Manchester, Greater Manchester, United Kingdom, M20 4Bx|Northwood, Middlesex, United Kingdom, Ha6 2Rn|Guildford, Surrey, United Kingdom, Gu2 7Xx Royal Marsden HospitalSutton, Surrey, United Kingdom, Sm2 5Pt|Northampton, United Kingdom, Nn1 5Bd|Tucson, Arizona, United States, 85711|Vallejo, California, United States, 94589|Gainesville, Florida, United States, 32610-0296|Boston, Massachusetts, United States, 02215|Kansas City, Missouri, United States, 63142|Tulsa, Oklahoma, United States, 74146|Philadelphia, Pennsylvania, United States, 19107|Providence, Rhode Island, United States, 02903|Sioux Falls, South Dakota, United States, 57104|Knoxville, Tennessee, United States, 37920 Sarah Cannon Research Institute ScriNashville, Tennessee, United States, 37203 Tennessee Oncology PllcNashville, Tennessee, United States, 37203|Seattle, Washington, United States, 98109","Arizona|California|Florida|Massachusetts|Missouri|Oklahoma|Pennsylvania|Rhode Island|South Dakota|Tennessee|Washington","Australia|Belgium|Israel|Italy|Spain|United Kingdom|United States","Australia, 5042 Burnside War Memorial Hospital|Flinders Medical Centre|New South Wales Concord Repatriation General Hospital|Queensland Royal Brisbane And Womens Hospital|Victoria Peter Maccallum Cancer Centre|Institut Jules Bordet|Rambam Medical Center|Lazio Policlinico Univ. Agostino Gemelli|Milan Istituto Europeo Di Oncologia|Naples Istituto Tumori Fondazione G. Pascale Irccs|Hospital Universitari Vall D'Hebron|, Greater London University College Hospital - London|, Greater Manchester Christie Nhs Foundation Trust|, Middlesex Mount Vernon Hospital|, Surrey Royal Surrey County Hospital|Northampton General Hospital|Arizona Oncology Associates, P.C.|Kaiser Permanente Medical Center|University Of Southern Florida School Of Medicine|Dana Farber Cancer Institute|Research Medical Center|Cancer Care Associates|Thomas Jefferson University|Rhode Island Hospital|Sioux Valley Clinic|University Of Tennessee Medical Center|Seattle Cancer Care Alliance",{"$nulls":3},"Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)","2019-06-17","2020-05-25T16:39:10.845","2020-05-26T17:10:42.972","NCT03414047"]
["5ecbf4afe2561b1b11905e8b","NCT03414047","2019-08-28","Eli Lilly","LLY","Active, not recruiting","A Study of Prexasertib (LY2606368) in Platinum-Resistant or Refractory Recurrent Ovarian Cancer","Prexasertib","CHK1 Inhibitor","Yes","['Prexasertib']","Yes","['CHK1 Inhibitor']","Phase 2",4,173,"Actual","2018-04-10","2019-06-03","RR|CR","Response Rate|Complete Response",{"$nulls":3},"The purpose of this study is to evaluate the efficacy and safety of prexasertib in women with platinum-resistant or refractory recurrent ovarian cancer.",null,"A Phase 2 Study of Prexasertib in Platinum-Resistant or Refractory Recurrent Ovarian Cancer",16712,"Ovarian Cancer","Ovarian Cancer","Oncology Solid Tumor","Oncology","Experimental","Prexasertib Cohort 1|Prexasertib Cohort 2|Prexasertib Cohort 3|Prexasertib Cohort 4","Participants with platinum-resistant disease that are breast cancer susceptibility gene (BRCA) negative and have received â‰¥3 lines of prior therapy.|Participants with platinum-resistant disease that are BRCA negative and have received <3 lines of prior therapy.|Participants with platinum-resistant disease that are BRCA positive and received a prior poly ADP ribose polymerase (PARP) inhibitor.|Participants with platinum refractory disease.","Drug","Prexasertib","Administered IV","LY2606368","Prexasertib Cohort 1|Prexasertib Cohort 2|Prexasertib Cohort 3|Prexasertib Cohort 4","\n\n * Women who have high-grade serous ovarian, primary peritoneal or fallopian tube cancer.\n * Cohorts 1 to 3: Have platinum-resistant disease and have documented test results assessing alterations in the BRCA1 and BRCA2 genes prior to receiving study treatment.\n * Cohort 1: Are BRCA negative and have received 3 or more prior lines of therapy.\n * Cohort 2: Are BRCA negative and have received less than 3 prior lines of therapy.\n * Cohort 3: Are BRCA positive and have previously received a PARP.\n * Cohort 4: Have primary platinum refractory disease.\n * Have adequate organ function.\n * Must be able and willing to undergo mandatory tumor biopsy.\n\n","\n\n * Cohorts 1-3: Have previously received all of the following agents at any time in the platinum-resistant setting: gemcitabine, pegylated liposomal doxorubicin, and paclitaxel.\n * Have known central nervous system malignancy or metastasis.\n * Have previously participated in any study involving a checkpoint kinase 1 inhibitor or have hypersensitivity to the study drug or excipients.\n * Have at least one of the following: * history of abdominal fistula or gastrointestinal perforation\n    * intra-abdominal abscess within last 3 months prior to the first dose of study drug\n    * a radiographically confirmed bowel obstruction within 3 months prior to the first dose of study drug\n   \n   \n * Have a symptomatic human immunodeficiency virus infection or symptomatic activated/reactivated hepatitis A, B, or C (screening is not required).\n * Have a serious cardiac condition.\n * Have a history of prior radiotherapy to the whole pelvis.\n * Have chronic daily treatment with corticosteroids, excluding inhaled or topical steroids.\n * Have known factors that may increase the risk of infection while on study drug treatment. These may include, but are not limited to, an indwelling peritoneal catheter or open wounds. Catheters for vascular access are permitted.","BRCA",null,"Protein","Breast","Actual","2018-01-29","Actual","Actual","2019-12-31","Anticipated","2019-08-01","2018-01-12","2018-01-22","2019-08-26","No","DNA damage repair\nreplication stress","Interventional","Treatment","Parallel Assignment","None (Open Label)","Non-Randomized","18 Years",null,"Female",null,"No","Yes\nAnonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.",null,"URL: https://www.lillytrialguide.com/en-US/studies/ovarian-cancer/JTJN#?postal= [https://www.lillytrialguide.com/en-US/studies/ovarian-cancer/JTJN#?postal=] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: A Study of Prexasertib (LY2606368) in Platinum-Resistant or Refractory Recurrent Ovarian Cancer",null,"Yes","No",{"$nulls":17},"I4D-MC-JTJN|2017-004009-42","Eli Lilly and Company|EudraCT Number","Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR): Overall Response Rate (ORR)","Percentage of participants who achieve CR or PR: ORR","Baseline through Disease Progression (estimated at up to 12 months)","Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of Prexasertib|Disease Control Rate (DCR): Proportion of Participants with a Best Overall Response of CR, PR, or Stable Disease (SD) for at Least 4 Months|Duration of Response|Percentage of Participants with at Least a 50% Reduction in CA-125 Levels from Baseline|Progression-Free Survival|Overall Survival","PK: Cmax of prexasertib on day 1 of cycles 1, 2, 4 and 6|DCR: Percentage of participants with a best overall response of CR, PR, or SD for at least 4 months|Duration of response|Percentage of participants with at least a 50% reduction in CA-125 levels from baseline|Progression-free survival|Overall survival","Cycle 1 End of Infusion (Day 1) up to 1-2 Hours Following End of Infusion on Day 1 of Cycle 6 (each cycle is 28 days)|Baseline through Disease Progression (estimated at up to 12 months)|Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (estimated at up to 24 months)|Baseline, 4 Weeks|Baseline to Disease Progression or Death from any Cause (estimated at up to 12 months)|Baseline to Date of Death from Any Cause (estimated at up to 24 months)",{"$nulls":3},"Toorak Gardens, South|Bedford Park, South|Concord, New South Wales, Australia, 2139 Prince Of Wales HospitalRandwick, New South Wales, Australia, 2031 Westmead HospitalWentworthville, New South Wales, Australia, 2145|Herston, Queensland, Australia, 4029 Mater Adult Hospital BrisbaneSouth Brisbane, Queensland, Australia, 4101|Melbourne, Victoria, Australia, 3000|Brussel, Belgium, 1000 Universitaire Ziekenhuizen Leuven - Campus GasthuisbergLeuven, Belgium, 3000 Gza St AugustinusWilrijk, Belgium, 2610|Haifa, Israel, 3109601 Shaare Zedek Medical CenterJerusalem, Israel, 9103102 Sheba Medical CenterRamat Gan, Israel, 5265601|Roma, Lazio, Italy, 00168|Milano, Milan, Italy, 20141|Napoli, Naples, Italy, 80131 Korea, Republic Of, Korea Samsung Medical CenterSeoul, Korea, Korea, Republic Of, 06351 Korea, Republic Of Seoul National University HospitalSeoul, Korea, Republic Of, 03080 Asan Medical CenterSeoul, Korea, Republic Of, 05505 Severance Hospital Yonsei University Health SystemSeoul, Korea, Republic Of, 120-792|Barcelona, Spain, 08035 Hospital Reina SofiaCordoba, Spain, 14004 Hospital Universitario Ramon Y CajalMadrid, Spain, 28034 Hospital Universitario 12 De OctubreMadrid, Spain, 28041 Hospital Universitario La PazMadrid, Spain, 28046|London, Greater London, United Kingdom, Nw1 2Bu|Manchester, Greater Manchester, United Kingdom, M20 4Bx|Northwood, Middlesex, United Kingdom, Ha6 2Rn|Guildford, Surrey, United Kingdom, Gu2 7Xx Royal Marsden HospitalSutton, Surrey, United Kingdom, Sm2 5Pt|Northampton, United Kingdom, Nn1 5Bd|Tucson, Arizona, United States, 85711|Vallejo, California, United States, 94589|Gainesville, Florida, United States, 32610-0296|Boston, Massachusetts, United States, 02215|Kansas City, Missouri, United States, 63142|Tulsa, Oklahoma, United States, 74146|Philadelphia, Pennsylvania, United States, 19107|Providence, Rhode Island, United States, 02903|Sioux Falls, South Dakota, United States, 57104|Knoxville, Tennessee, United States, 37920 Sarah Cannon Research Institute ScriNashville, Tennessee, United States, 37203 Tennessee Oncology PllcNashville, Tennessee, United States, 37203|Seattle, Washington, United States, 98109","Arizona|California|Florida|Massachusetts|Missouri|Oklahoma|Pennsylvania|Rhode Island|South Dakota|Tennessee|Washington","Australia|Belgium|Israel|Italy|Spain|United Kingdom|United States","Australia, 5042 Burnside War Memorial Hospital|Flinders Medical Centre|New South Wales Concord Repatriation General Hospital|Queensland Royal Brisbane And Womens Hospital|Victoria Peter Maccallum Cancer Centre|Institut Jules Bordet|Rambam Medical Center|Lazio Policlinico Univ. Agostino Gemelli|Milan Istituto Europeo Di Oncologia|Naples Istituto Tumori Fondazione G. Pascale Irccs|Hospital Universitari Vall D'Hebron|, Greater London University College Hospital - London|, Greater Manchester Christie Nhs Foundation Trust|, Middlesex Mount Vernon Hospital|, Surrey Royal Surrey County Hospital|Northampton General Hospital|Arizona Oncology Associates, P.C.|Kaiser Permanente Medical Center|University Of Southern Florida School Of Medicine|Dana Farber Cancer Institute|Research Medical Center|Cancer Care Associates|Thomas Jefferson University|Rhode Island Hospital|Sioux Valley Clinic|University Of Tennessee Medical Center|Seattle Cancer Care Alliance",{"$nulls":3},"Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)","2019-08-26","2020-05-25T16:39:11.144","2020-05-26T17:10:42.972","NCT03414047"]
["5ecbf4af11702c1b1b916b9f","NCT03414255","2018-01-29","MiMedx Group","MDXG","Recruiting","Micronized dHACM Injectable for the Treatment of Achille Tendonitis","Sodium chloride",null,"Unknown",null,"Unknown",null,"Phase 3",2,158,"Anticipated","2018-01-01","2019-12-01",{"$nulls":5},"Prospective, Double-Blinded, Randomized Controlled Trial of the Micronized dHACM Injection as Compared to Saline Placebo Injection in the Treatment of Achilles Tendonitis","Approximately 158 subjects will be enrolled in this study. Each patient will receive 1 injection and be evaluated for efficacy and safety during a 12 month observation period. Randomization will be 1:1. The study is expected to be completed in 24 months, inclusive of enrollment and follow-up of all subjects.","A Phase 3, Prospective, Double-Blinded, Randomized Controlled Trial Of The Micronized dHACM Injection As Compared To Saline Placebo Injection In The Treatment Of Achilles Tendonitis","AIAT001","Tendonitis;Achilles",{"$nulls":3},"Experimental|Placebo Comparator","Micronized DHACM|Saline Injection","1mL injection of 40mg Micronized dehydrated human amnion/chorion membrane (DHACM)|Injection of 1mL 0.9% Sodium Chloride Injection, USP","Biological|Drug","Micronized DHACM|Saline Injection","1 mL injection of 40mg Micronized dehydrated human amnion/chorion membrane (DHACM).|Injection of 1mL 0.9% Sodium Chloride Injection, USP","dHACM|0.9% NaCL | Normal Saline\n | Sodium Chloride Injection, USP","Micronized DHACM|Saline Injection","All subjects enrolled must meet all the following criteria:\n\n 1. Confirmed diagnosis of Achilles tendonitis for â‰¥ 1 month (30 days) and â‰¤ 18 months by the investigator\n 2. VAS Pain scale of â‰¥ 45 at randomization\n 3. Achilles Tendonitis with conservative treatment for â‰¥1 month (30 days) while under the direction of the healthcare provider, including any of the following modalities: * Rest, Ice, Compression, Elevation (RICE)\n     * Stretching exercises\n     * Nonsteroidal Anti-inflammatory Drugs (NSAIDs)\n     * Orthotics\n    \n    \n 4. Diagnostic AP and lateral X-Ray within 6 months of enrollment showing view of calcaneus negative for calcaneal fracture or structural abnormalities\n 5. BMI â‰¤ 40 kg/m2\n 6. Age from 21 to 80 years\n 7. Ability to sign Informed Consent and Release of Medical Information Forms\n 8. Ability to receive and respond to text messages or emails on a daily basis.\n\n"," Any potential subjects meeting any of the following criteria will be excluded from enrollment and subsequent randomization.\n\n 1.  Prior surgery to the affected site.\n 2.  Subjects requiring bilateral Achilles tendonitis treatment at time of enrollment\n 3.  Prior use of any lower limb injection therapy, including corticosteroids or PRP in either limb within the last 3 months\n 4.  Has diabetes either Type I or Type II\n 5.  Systemic disorders associated with enthesopathy (disorder of entheses, i.e. bone attachments) such as Gout, Reiter's syndrome, rheumatoid arthritis, etc.\n 6.  The presence of diagnosed comorbidities that can be confused with or can exacerbate the condition- to be assessed by X-ray - including but not limited to: * Calcaneal stress fracture\n      * Suspected partial thickness tear of the Achilles tendon, as assessed by the investigator\n      * Calcaneal tumor\n      * Tarsal tunnel syndrome (diagnosed)\n      * Significant bone deformity of the foot that may interfere with the study\n     \n     \n 7.  The presence of diagnosed comorbidities that require surgery or are unlikely to improve - to be assessed by Investigator-including but not limited to: * Nerve entrapment syndrome\n      * Acute traumatic rupture of the Achilles tendon\n      * Partial thickness tears of the Achilles Tendon\n     \n     \n 8.  Affected site exhibits clinical signs and symptoms of infection\n 9.  Known allergy or known sensitivity to Aminoglycosides\n 10. Subjects who are non-ambulatory\n 11. History of more than 14 days of treatment with immune-suppressants (including systemic corticosteroids) or cytotoxic chemotherapy within 30 days prior to enrollment, or who are anticipated to require such medications during the course of the study\n 12. Prior radiation at the site\n 13. Use of any investigational drug(s) or therapeutic device(s) within 3 months preceding enrollment\n 14. Immune system disorders including Systemic Lupus Erythematosus (SLE), Fibromyalgia, Acquired Immunodeficiency Syndrome (AIDS), Human Immunodeficiency Virus (HIV) or Lyme disease\n 15. History of any conditions (including drug or alcohol abuse, medical or psychiatric condition) that is likely to impair understanding of or compliance with the study protocol, in the judgment of the investigator\n 16. Pregnancy at enrollment or within last 6 months, women who are breastfeeding, or women of childbearing potential who are planning to become pregnant during the time of the study OR are unwilling/unable to use acceptable methods of contraception (birth control pills, barriers, or abstinence)\n 17. Workers' compensation patients ",{"$nulls":4},"Actual","2018-01-29","Actual","Anticipated","2019-12-01","Anticipated","2018-01-01","2018-01-23","2018-01-26","2018-01-26","Yes","Chronic Achilles Tendonitis","Interventional","Treatment","Parallel Assignment","Double (Participant, Outcomes Assessor)","Randomized","21 Years","80 Years","All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":19},"Change in VAS score|Incidence of adverse events","90 days|365 days",null,"Foot Function Index Revised (FFI-R) (Short Form)","90 days",{"$nulls":4},"Fresno, California, United States, 93721|Virginia Beach, Virginia, United States, 23464","California|Virginia","United States","Limb Preservation Platform, Inc|Coastal Podiatry, Inc.",{"$nulls":4},"2018-01-26","2020-05-25T16:39:11.230","2020-05-26T17:10:42.972","NCT03414255"]
["5ecbf4affeab101b155309c1","NCT03414255","2018-10-12","MiMedx Group","MDXG","Recruiting","Micronized dHACM Injectable for the Treatment of Achille Tendonitis","Sodium chloride",null,"Unknown",null,"Unknown",null,"Phase 3",2,158,"Anticipated","2018-01-09","2019-12-01",{"$nulls":5},"Prospective, Double-Blinded, Randomized Controlled Trial of the Micronized dHACM Injection as Compared to Saline Placebo Injection in the Treatment of Achilles Tendonitis","Approximately 158 subjects will be enrolled in this study. Each patient will receive 1 injection and be evaluated for efficacy and safety during a 12 month observation period. Randomization will be 1:1. The study is expected to be completed in 24 months, inclusive of enrollment and follow-up of all subjects.","A Phase 3, Prospective, Double-Blinded, Randomized Controlled Trial Of The Micronized dHACM Injection As Compared To Saline Placebo Injection In The Treatment Of Achilles Tendonitis","AIAT001","Tendonitis;Achilles",{"$nulls":3},"Experimental|Placebo Comparator","Micronized DHACM|Saline Injection","1mL injection of 40mg Micronized dehydrated human amnion/chorion membrane (DHACM)|Injection of 1mL 0.9% Sodium Chloride Injection, USP","Biological|Drug","Micronized DHACM|Saline Injection","1 mL injection of 40mg Micronized dehydrated human amnion/chorion membrane (DHACM).|Injection of 1mL 0.9% Sodium Chloride Injection, USP","dHACM|0.9% NaCL | Normal Saline\n | Sodium Chloride Injection, USP","Micronized DHACM|Saline Injection","All subjects enrolled must meet all the following criteria:\n\n 1. Confirmed diagnosis of Achilles tendonitis for â‰¥ 1 month (30 days) and â‰¤ 18 months by the investigator\n 2. VAS Pain scale of â‰¥ 45 at randomization\n 3. Achilles Tendonitis with conservative treatment for â‰¥1 month (30 days) while under the direction of the healthcare provider, including any of the following modalities: * Rest, Ice, Compression, Elevation (RICE)\n     * Stretching exercises\n     * Nonsteroidal Anti-inflammatory Drugs (NSAIDs)\n     * Orthotics\n    \n    \n 4. Diagnostic AP and lateral X-Ray within 6 months of enrollment showing view of calcaneus negative for calcaneal fracture or structural abnormalities\n 5. BMI â‰¤ 40 kg/m2\n 6. Age from 21 to 80 years\n 7. Ability to sign Informed Consent and Release of Medical Information Forms\n 8. Ability to receive and respond to text messages or emails on a daily basis.\n\n"," Any potential subjects meeting any of the following criteria will be excluded from enrollment and subsequent randomization.\n\n 1.  Prior surgery to the affected site.\n 2.  Subjects requiring bilateral Achilles tendonitis treatment at time of enrollment\n 3.  Prior use of any lower limb injection therapy, including corticosteroids or PRP in either limb within the last 3 months\n 4.  Has diabetes either Type I or Type II\n 5.  Systemic disorders associated with enthesopathy (disorder of entheses, i.e. bone attachments) such as Gout, Reiter's syndrome, rheumatoid arthritis, etc.\n 6.  The presence of diagnosed comorbidities that can be confused with or can exacerbate the condition- to be assessed by X-ray - including but not limited to: * Calcaneal stress fracture\n      * Suspected partial thickness tear of the Achilles tendon, as assessed by the investigator\n      * Calcaneal tumor\n      * Tarsal tunnel syndrome (diagnosed)\n      * Significant bone deformity of the foot that may interfere with the study\n     \n     \n 7.  The presence of diagnosed comorbidities that require surgery or are unlikely to improve - to be assessed by Investigator-including but not limited to: * Nerve entrapment syndrome\n      * Acute traumatic rupture of the Achilles tendon\n      * Partial thickness tears of the Achilles Tendon\n     \n     \n 8.  Affected site exhibits clinical signs and symptoms of infection\n 9.  Known allergy or known sensitivity to Aminoglycosides\n 10. Subjects who are non-ambulatory\n 11. History of more than 14 days of treatment with immune-suppressants (including systemic corticosteroids) or cytotoxic chemotherapy within 30 days prior to enrollment, or who are anticipated to require such medications during the course of the study\n 12. Prior radiation at the site\n 13. Use of any investigational drug(s) or therapeutic device(s) within 3 months preceding enrollment\n 14. Immune system disorders including Systemic Lupus Erythematosus (SLE), Fibromyalgia, Acquired Immunodeficiency Syndrome (AIDS), Human Immunodeficiency Virus (HIV) or Lyme disease\n 15. History of any conditions (including drug or alcohol abuse, medical or psychiatric condition) that is likely to impair understanding of or compliance with the study protocol, in the judgment of the investigator\n 16. Pregnancy at enrollment or within last 6 months, women who are breastfeeding, or women of childbearing potential who are planning to become pregnant during the time of the study OR are unwilling/unable to use acceptable methods of contraception (birth control pills, barriers, or abstinence)\n 17. Workers' compensation patients ",{"$nulls":4},"Actual","2018-01-29","Actual","Anticipated","2019-12-01","Anticipated","2018-08-01","2018-01-23","2018-01-26","2018-10-11","Yes","Chronic Achilles Tendonitis","Interventional","Treatment","Parallel Assignment","Double (Participant, Outcomes Assessor)","Randomized","21 Years","80 Years","All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":19},"Change in VAS score|Incidence of adverse events","Visual Analog Scale, Left end point is \"No Pain\". Right end point is \"worst pain imaginable\"|The incidence of related Adverse Events (AEs), Serious Adverse Events (SAEs), and Unanticipated Adverse Events during the first 12 months post injection","90 days|365 days","Foot Function Index Revised (FFI-R) (Short Form)","Subjects circle the number that correlates how bad their foot pain was in certain situation.","90 days",{"$nulls":3},"Birmingham, Alabama, United States, 35205|Tucson, Arizona, United States, 85723Principal Investigator: Jodi Walters, Dpm|Carlsbad, California, United States, 92009|Miami, Florida, United States, 33125Principal Investigator: Jimmy Trang, Dpm Doctors Research NetworkMiami, Florida, United States, 33143|Atlanta, Georgia, United States, 30327Principal Investigator: Charles Garten, Md Northside PodiatryBuford, Georgia, United States, 30518|Springfield, Illinois, United States, 62704|Las Vegas, Nevada, United States, 89119|Altoona, Pennsylvania, United States, 16602|Mcallen, Texas, United States, 78501|Midlothian, Virginia, United States, 23114 Coastal Podiatry, Inc.Virginia Beach, Virginia, United States, 23464","Alabama|Arizona|California|Florida|Georgia|Illinois|Nevada|Pennsylvania|Texas|Virginia","United States","Central Research Associates|Southern Arizona Va Health Care System|Ild Research Center|South Florida Veterans Affairs|Paragon Sports Medicine|Foot And Ankle Center Of Illinois|Advanced Foot & Ankle Center|University Orthopedics Center|Futuro Clinical Trials|Virginia Research Center",{"$nulls":4},"2018-10-11","2020-05-25T16:39:11.230","2020-05-26T17:10:42.972","NCT03414255"]
["5ecbf4b0feab101b155309c3","NCT03414268","2018-01-29","MiMedx Group","MDXG","Recruiting","Micronized dHACM Injectable for the Treatment of Plantar Fasciitis","Sodium chloride",null,"Unknown",null,"Unknown",null,"Phase 3",2,164,"Anticipated","2018-01-01","2019-10-01",{"$nulls":5},"Prospective, double-blinded, randomized controlled trial of the micronized dHACM injection as compared to the saline placebo injection in the treatment of plantar fasciitis","Approximately 164 patients will be enrolled in this study. Each patient will receive 1 injection and be evaluated for efficacy and safety during a 6-month observation period. Randomization will be 1:1. The study is expected to be completed within 24 months, inclusive of enrollment and follow-up of all subjects.","A Phase 3, Prospective, Double-Blinded, Randomized Controlled Trial of the Micronized dHACM Injection As Compared To Saline Placebo Injection In The Treatment Of Plantar Fasciitis","AIPF007","Fasciitis, Plantar","Fasciitis, Plantar","Fasciitis","Musculoskeletal","Experimental|Placebo Comparator","Micronized dHACM|Saline Injection","1 mL injection of 40 mg Micronized dehydrated human amnion/chorion membrane (dHACM)|Injection of 1mL 0.9% Sodium Chloride Injection, USP","Drug","Micronized dHACM|Saline Injection","1 mL injection of 40 mg Micronized dehydrated human amnion/chorion membrane (dHACM)|Injection of 1mL 0.9% Sodium Chloride Injection, USP","dHACM|0.9% NaCl | Normal Saline\n | Sodium Chloride Injection, USP","Micronized dHACM|Saline Injection","\n\n 1. Confirmed diagnosis of plantar fasciitis for â‰¥ 1 month (30 days) and â‰¤ 18 months by the investigator\n 2. VAS Pain scale of â‰¥ 45 mm at randomization\n 3. Plantar fasciitis with conservative treatment for â‰¥ 1 month (30 days), including any of the following modalities: * RICE\n     * Stretching exercises\n     * NSAIDs\n     * Orthotics\n    \n    \n 4. Diagnostic X-Ray within 6 months of enrollment showing view of calcaneus negative for calcaneal fracture or structural abnormalities\n 5. BMI â‰¤ 40 kg/m2\n 6. Age â‰¥ 21 years and < 80 years\n 7. Ability to sign Informed Consent and Release of Medical Information Forms\n 8. Ability to receive and respond to text messages or emails on a daily basis.\n\n","\n\n 1.  Prior surgery or trauma to the affected site\n 2.  Subjects requiring bilateral plantar fasciitis treatment at time of enrollment\n 3.  Prior use of any lower limb injection therapy, including corticosteroids or PRP in either limb within the last 3 months\n 4.  Has diabetes either Type I or Type II.\n 5.  Systemic disorders associated with enthesopathy (disorder of entheses, i.e. bone attachments) such as Gout, Reiter's syndrome, rheumatoid arthritis, etc.\n 6.  The presence of diagnosed comorbidities that can be confused with or can exacerbate the condition- to be assessed by X-ray - including but not limited to: * Calcaneal stress fracture\n      * Nerve entrapment syndrome (diagnosed as Baxter Nerve Syndrome)\n      * Fat pad atrophy\n      * Acute traumatic rupture of the plantar fascia\n      * Calcaneal tumor\n      * Tarsal tunnel syndrome (diagnosed)\n      * Significant bone deformity of the foot that may interfere with the study\n     \n     \n 7.  Affected site exhibits clinical signs and symptoms of infection\n 8.  Known allergy or known sensitivity to Aminoglycosides\n 9.  Subjects who are non-ambulatory\n 10. History of more than 14 days treatment with immuno-suppressants (including systemic corticosteroids) or cytotoxic chemotherapy within 30 days prior to enrollment, or who are anticipated to require such medications during the course of the study\n 11. Prior radiation at the site\n 12. Use of any investigational drug(s) or therapeutic device(s) within 3 months preceding enrollment\n 13. Immune disorders including Systemic Lupus Erythematosus (SLE), Fibromyalgia, Acquired Immunodeficiency Syndrome (AIDS) or Human Immunodeficiency Virus (HIV)\n 14. History of any condition (including drug or alcohol abuse, medical or psychiatric condition) that is likely to impair understanding of or compliance with the study protocol, in the judgment of the investigator\n 15. Pregnancy at enrollment or within last 6 months, women who are breastfeeding, or women of childbearing potential who are planning to become pregnant during the time of the study OR are unwilling/unable to use acceptable methods of contraception (birth control pills, barriers, or abstinence)\n 16. Workers' compensation subjects",{"$nulls":4},"Actual","2018-01-29","Actual","Anticipated","2019-10-01","Anticipated","2018-01-01","2018-01-23","2018-01-26","2018-01-26","Yes","Chronic plantar fasciitis\nHeel pain","Interventional","Treatment","Parallel Assignment","Double (Participant, Outcomes Assessor)","Randomized","21 Years","79 Years","All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":19},"Change in VAS score|Incidence of adverse events","90 Days|180 Days",null,"Foot Function Index - Revised (FFI-R) (Short Form)","90 Days",{"$nulls":4},"Fresno, California, United States, 93721|Virginia Beach, Virginia, United States, 23464","California|Virginia","United States","Limb Preservation Platform, Inc.|Coastal Podiatry",{"$nulls":4},"2018-01-26","2020-05-25T16:39:12.175","2020-05-26T17:10:42.972","NCT03414268"]
["5ecbf4b0e2561b1b11905e8d","NCT03414268","2018-01-31","MiMedx Group","MDXG","Recruiting","Micronized dHACM Injectable for the Treatment of Plantar Fasciitis","Sodium chloride",null,"Unknown",null,"Unknown",null,"Phase 3",2,164,"Anticipated","2018-01-01","2019-10-01",{"$nulls":5},"Prospective, double-blinded, randomized controlled trial of the micronized dHACM injection as compared to the saline placebo injection in the treatment of plantar fasciitis","Approximately 164 patients will be enrolled in this study. Each patient will receive 1 injection and be evaluated for efficacy and safety during a 6-month observation period. Randomization will be 1:1. The study is expected to be completed within 24 months, inclusive of enrollment and follow-up of all subjects.","A Phase 3, Prospective, Double-Blinded, Randomized Controlled Trial of the Micronized dHACM Injection As Compared To Saline Placebo Injection In The Treatment Of Plantar Fasciitis","AIPF007","Fasciitis, Plantar","Fasciitis, Plantar","Fasciitis","Musculoskeletal","Experimental|Placebo Comparator","Micronized dHACM|Saline Injection","1 mL injection of 40 mg Micronized dehydrated human amnion/chorion membrane (dHACM)|Injection of 1mL 0.9% Sodium Chloride Injection, USP","Drug","Micronized dHACM|Saline Injection","1 mL injection of 40 mg Micronized dehydrated human amnion/chorion membrane (dHACM)|Injection of 1mL 0.9% Sodium Chloride Injection, USP","dHACM|0.9% NaCl | Normal Saline\n | Sodium Chloride Injection, USP","Micronized dHACM|Saline Injection","\n\n 1. Confirmed diagnosis of plantar fasciitis for â‰¥ 1 month (30 days) and â‰¤ 18 months by the investigator\n 2. VAS Pain scale of â‰¥ 45 mm at randomization\n 3. Plantar fasciitis with conservative treatment for â‰¥ 1 month (30 days), including any of the following modalities: * RICE\n     * Stretching exercises\n     * NSAIDs\n     * Orthotics\n    \n    \n 4. Diagnostic X-Ray within 6 months of enrollment showing view of calcaneus negative for calcaneal fracture or structural abnormalities\n 5. BMI â‰¤ 40 kg/m2\n 6. Age â‰¥ 21 years and < 80 years\n 7. Ability to sign Informed Consent and Release of Medical Information Forms\n 8. Ability to receive and respond to text messages or emails on a daily basis.\n\n","\n\n 1.  Prior surgery or trauma to the affected site\n 2.  Subjects requiring bilateral plantar fasciitis treatment at time of enrollment\n 3.  Prior use of any lower limb injection therapy, including corticosteroids or PRP in either limb within the last 3 months\n 4.  Has diabetes either Type I or Type II.\n 5.  Systemic disorders associated with enthesopathy (disorder of entheses, i.e. bone attachments) such as Gout, Reiter's syndrome, rheumatoid arthritis, etc.\n 6.  The presence of diagnosed comorbidities that can be confused with or can exacerbate the condition- to be assessed by X-ray - including but not limited to: * Calcaneal stress fracture\n      * Nerve entrapment syndrome (diagnosed as Baxter Nerve Syndrome)\n      * Fat pad atrophy\n      * Acute traumatic rupture of the plantar fascia\n      * Calcaneal tumor\n      * Tarsal tunnel syndrome (diagnosed)\n      * Significant bone deformity of the foot that may interfere with the study\n     \n     \n 7.  Affected site exhibits clinical signs and symptoms of infection\n 8.  Known allergy or known sensitivity to Aminoglycosides\n 9.  Subjects who are non-ambulatory\n 10. History of more than 14 days treatment with immuno-suppressants (including systemic corticosteroids) or cytotoxic chemotherapy within 30 days prior to enrollment, or who are anticipated to require such medications during the course of the study\n 11. Prior radiation at the site\n 12. Use of any investigational drug(s) or therapeutic device(s) within 3 months preceding enrollment\n 13. Immune disorders including Systemic Lupus Erythematosus (SLE), Fibromyalgia, Acquired Immunodeficiency Syndrome (AIDS) or Human Immunodeficiency Virus (HIV)\n 14. History of any condition (including drug or alcohol abuse, medical or psychiatric condition) that is likely to impair understanding of or compliance with the study protocol, in the judgment of the investigator\n 15. Pregnancy at enrollment or within last 6 months, women who are breastfeeding, or women of childbearing potential who are planning to become pregnant during the time of the study OR are unwilling/unable to use acceptable methods of contraception (birth control pills, barriers, or abstinence)\n 16. Workers' compensation subjects",{"$nulls":4},"Actual","2018-01-29","Actual","Anticipated","2019-10-01","Anticipated","2018-01-01","2018-01-23","2018-01-26","2018-01-29","Yes","Chronic plantar fasciitis\nHeel pain","Interventional","Treatment","Parallel Assignment","Double (Participant, Outcomes Assessor)","Randomized","21 Years","79 Years","All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":19},"Change in VAS score|Incidence of adverse events","Visual Analog Scale for Pain:|The incidence of related Adverse Events (AEs), Serious Adverse Events (SAEs), and Unanticipated Adverse Events during the first 12 months post injection","90 Days|180 Days","Foot Function Index - Revised (FFI-R) (Short Form)","Foot Function Index - Revised: Patient Reported Questionnaire","90 Days",{"$nulls":3},"Fresno, California, United States, 93721|Virginia Beach, Virginia, United States, 23464","California|Virginia","United States","Limb Preservation Platform, Inc.|Coastal Podiatry",{"$nulls":4},"2018-01-29","2020-05-25T16:39:12.175","2020-05-26T17:10:42.972","NCT03414268"]
["5ecbf4b0307e3d1b1f8d9e26","NCT03414268","2019-11-08","MiMedx Group","MDXG","Recruiting","Micronized dHACM Injectable for the Treatment of Plantar Fasciitis","Sodium chloride",null,"Unknown",null,"Unknown",null,"Phase 3",2,276,"Anticipated","2018-01-08","2020-08-01",{"$nulls":5},"Prospective, double-blinded, randomized controlled trial of the micronized dHACM injection as compared to the saline placebo injection in the treatment of plantar fasciitis","Approximately 276 patients will be enrolled in this study. Each patient will receive 1 injection and be evaluated for efficacy and safety during a 6-month observation period. Randomization will be 1:1. The study is expected to be completed within 34 months, inclusive of enrollment and follow-up of all subjects.","A Phase 3, Prospective, Double-Blinded, Randomized Controlled Trial of the Micronized dHACM Injection As Compared To Saline Placebo Injection In The Treatment Of Plantar Fasciitis","AIPF007","Fasciitis, Plantar","Fasciitis, Plantar","Fasciitis","Musculoskeletal","Experimental|Placebo Comparator","Micronized dHACM|Saline Injection","1 mL injection of 40 mg Micronized dehydrated human amnion/chorion membrane (dHACM)|Injection of 1mL 0.9% Sodium Chloride Injection, USP","Drug","Micronized dHACM|Saline Injection","1 mL injection of 40 mg Micronized dehydrated human amnion/chorion membrane (dHACM)|Injection of 1mL 0.9% Sodium Chloride Injection, USP","dHACM|0.9% NaCl | Normal Saline\n | Sodium Chloride Injection, USP","Micronized dHACM|Saline Injection","\n\n 1. Confirmed diagnosis of plantar fasciitis for â‰¥ 1 month (30 days) and â‰¤ 18 months by the investigator\n 2. VAS Pain scale of â‰¥ 45 mm at randomization\n 3. Plantar fasciitis with conservative treatment for â‰¥ 1 month (30 days), including any of the following modalities: * RICE\n     * Stretching exercises\n     * NSAIDs\n     * Orthotics\n    \n    \n 4. Diagnostic X-Ray within 6 months of enrollment showing view of calcaneus negative for calcaneal fracture or structural abnormalities\n 5. BMI â‰¤ 40 kg/m2\n 6. Age â‰¥ 21 years and < 80 years\n 7. Ability to sign Informed Consent and Release of Medical Information Forms\n 8. Ability to receive and respond to text messages or emails on a daily basis.\n\n","\n\n 1.  Prior surgery or trauma to the affected site\n 2.  Subjects requiring bilateral plantar fasciitis treatment at time of enrollment\n 3.  Prior use of any lower limb injection therapy, including corticosteroids or PRP in either limb within the last 3 months\n 4.  Has diabetes either Type I or Type II.\n 5.  Systemic disorders associated with enthesopathy (disorder of entheses, i.e. bone attachments) such as Gout, Reiter's syndrome, rheumatoid arthritis, etc.\n 6.  The presence of diagnosed comorbidities that can be confused with or can exacerbate the condition- to be assessed by X-ray - including but not limited to: * Calcaneal stress fracture\n      * Nerve entrapment syndrome (diagnosed as Baxter Nerve Syndrome)\n      * Fat pad atrophy\n      * Acute traumatic rupture of the plantar fascia\n      * Calcaneal tumor\n      * Tarsal tunnel syndrome (diagnosed)\n      * Significant bone deformity of the foot that may interfere with the study\n     \n     \n 7.  Affected site exhibits clinical signs and symptoms of infection\n 8.  Known allergy or known sensitivity to Aminoglycosides\n 9.  Subjects who are non-ambulatory\n 10. History of more than 14 days treatment with immuno-suppressants (including systemic corticosteroids) or cytotoxic chemotherapy within 30 days prior to enrollment, or who are anticipated to require such medications during the course of the study\n 11. Prior radiation at the site\n 12. Use of any investigational drug(s) or therapeutic device(s) within 3 months preceding enrollment\n 13. Immune disorders including Systemic Lupus Erythematosus (SLE), Fibromyalgia, Acquired Immunodeficiency Syndrome (AIDS) or Human Immunodeficiency Virus (HIV)\n 14. History of any condition (including drug or alcohol abuse, medical or psychiatric condition) that is likely to impair understanding of or compliance with the study protocol, in the judgment of the investigator\n 15. Pregnancy at enrollment or within last 6 months, women who are breastfeeding, or women of childbearing potential who are planning to become pregnant during the time of the study OR are unwilling/unable to use acceptable methods of contraception (birth control pills, barriers, or abstinence)\n 16. Workers' compensation subjects",{"$nulls":4},"Actual","2018-01-29","Actual","Anticipated","2020-11-01","Anticipated","2019-09-01","2018-01-23","2018-01-26","2019-11-07","Yes","Chronic plantar fasciitis\nHeel pain","Interventional","Treatment","Parallel Assignment","Double (Participant, Outcomes Assessor)","Randomized","21 Years","79 Years","All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":19},"Change in VAS score|Incidence of adverse events","Visual Analog Scale for Pain:|The incidence of related Adverse Events (AEs), Serious Adverse Events (SAEs), and Unanticipated Adverse Events during the first 12 months post injection","90 Days|180 Days","Foot Function Index - Revised (FFI-R) (Short Form)","Foot Function Index - Revised: Patient Reported Questionnaire","90 Days",{"$nulls":3},"Tucson, Arizona, United States, 85723|[Active, Not Recruiting]Carlsbad, California, United States, 92009 Limb Preservation Platform, Inc.Fresno, California, United States, 93721 Horizon Clinical ResearchLa Mesa, California, United States, 91942|Bay Pines, Florida, United States, 33744|New Orleans, Louisiana, United States, 70121|Baltimore, Maryland, United States, 21218|[Active, Not Recruiting]Las Vegas, Nevada, United States, 89119|Altoona, Pennsylvania, United States, 16602|Mcallen, Texas, United States, 78501 Endeavor Clinical TrialsSan Antonio, Texas, United States, 78229|Virginia Beach, Virginia, United States, 23464","Arizona|California|Florida|Louisiana|Maryland|Nevada|Pennsylvania|Texas|Virginia","United States","Southern Arizona Va Health Care System|Ild Research Center|Bay Pines Va Healthcare System|Ochsner Medical Center|Union Podiatry|Advanced Foot & Ankle Center|University Orthopedics Center|Futuro Clinical Trials, Llc|Coastal Podiatry",{"$nulls":4},"2019-11-07","2020-05-25T16:39:12.374","2020-05-26T17:10:42.972","NCT03414268"]
["5ecbf4b3feab101b155309ca","NCT03414723","2018-01-30","Sanofi","SNY","Recruiting","A Drug-Drug Interaction Study Between Sotagliflozin and Ramipril","Sotagliflozin|Ramipril","SGLT1 Inhibitor|SGLT2 Inhibitor|ACE Inhibitor","Yes","['Sotagliflozin']","Yes","['SGLT1 Inhibitor']","Phase 1",1,16,"Anticipated","2018-01-15","2018-03-01","AUC","Area Under The Curve",{"$nulls":3},"Primary Objective:\n\nTo evaluate the effects of multiple-dose ramipril on the steady state pharmacokinetic (PK) parameters of sotagliflozin and its main metabolite (sotagliflozin-3-O-glucuronide) in healthy male and female subjects.\n\nSecondary Objectives:\n\n * To assess the effects of multiple-dose sotagliflozin on the PK of ramipril and its active metabolite (ramiprilat).\n * To assess the safety and tolerability of multiple-dose sotagliflozin with and without multiple-dose of ramipril.","The expected duration of subject participation, including Screening of up to 29 days, Treatment Periods of 6 days and 11 days each with a Washout period of minimum of 7 days in between periods, Follow-up period of 6 days, and end-of-study-period of 10-14 days after last sotagliflozin dose, is approximately 66 days.","An Open Label, 2-treatment, 2-period, Single Sequence Study to Evaluate Pharmacokinetic Drug-drug Interaction Between Ramipril and Sotagliflozin at Steady State in Healthy Subjects","INT14935","Diabetes Mellitus\nHealthy Subjects","Healthy Volunteers|General Diabetes","Healthy|Metabolic Diseases","Healthy|Nutritional Disorders","Experimental","SAR439954 with or without ramipril",null,"Drug","Sotagliflozin (SAR439954)|Ramipril",null,null,"SAR439954 with or without ramipril"," * Healthy male or female subjects, between 18 and 55 years of age, inclusive.\n * Body weight between 50.0 and 100.0 kg, inclusive, if male, and between 40.0 and 90.0 kg, inclusive, if female, body mass index between 18.0 and 32.0 kg/mÂ², inclusive.\n * Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination).\n * Normal vital signs after 10 minutes resting in supine position:\n * 100 mmHg <systolic blood pressure (SBP) <140 mmHg,\n * 60 mmHg <diastolic blood pressure (DBP) <90 mmHg,\n * 50 bpm <heart rate (HR) <90 bpm.\n * Standard 12-lead electrocardiogram (ECG) parameters after 10 minutes resting in supine position in the following ranges; 120 ms<PR<200 ms, QRS <120 ms, QTc â‰¤430 ms if male and QTc â‰¤450 ms if female with normal ECG tracing unless the Investigator considers an ECG tracing abnormality to be not clinically relevant.\n * Laboratory parameters within the normal range, unless the Investigator considers an abnormality to be clinically irrelevant for healthy subjects; however serum creatinine, alkaline phosphatase, hepatic enzymes (aspartate aminotransferase, alanine aminotransferase) should be strictly below the ULN. Total bilirubin out of normal range can be acceptable if total bilirubin should not exceed 1.5 the upper limit with normal conjugated bilirubin values (unless the subject has documented Gilbert syndrome).\n * Female subject must use a double contraception method including a highly effective method of birth control except if she has undergone sterilization at least 3 months earlier or is postmenopausal. The accepted double contraception methods include the use of 1 of the following contraceptive options: (1) intrauterine device; (2) condom or diaphragm or cervical/vault cap, in addition to spermicide. Menopause is defined as being amenorrheic for at least 2 years with plasma follicle stimulating hormone (FSH) value being within the normal range for postmenopausal women according to the local laboratory. Hormonal contraception is NOT acceptable in this study due to drug interaction.\n * Having given written informed consent prior to undertaking any study-related procedure.\n\n"," * Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, or infectious disease, or signs of acute illness.\n * History of renal disease, or significant abnormal kidney function test with glomerular filtration rate (GFR) <90 mL/min as calculated using the Cockcroft-Gault equation.\n * Frequent headaches and/or migraine, recurrent nausea and/or vomiting (more than twice a month).\n * Blood donation, any volume, within 2 months before inclusion.\n * Symptomatic postural hypotension, irrespective of the decrease in blood pressure, or asymptomatic postural hypotension defined as a decrease in systolic blood pressure â‰¥20 mmHg within 3 minutes when changing from supine to standing position.\n * Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician.\n * History or presence of drug or alcohol abuse (alcohol consumption more than 40 g per day on a regular basis).\n * Smoking more than 5 cigarettes or equivalent per day, unable to stop smoking during the study.\n * Excessive consumption of beverages containing xanthine bases (more than 4 cups or glasses per day)\n * If female, pregnancy (defined as positive Î²-HCG blood test if applicable), breast-feeding.\n * Any medication (including St John's Wort) within 14 days before inclusion or within 5 times the elimination half-life or pharmacodynamic half-life of the medication; any vaccination within the last 28 days and any biologics (antibody or its derivatives) given within 4 months before inclusion. Any oral contraceptives during the screening period or for at least 15 days prior to inclusion; any injectable contraceptives or hormonal intrauterine devices within 12 months prior to inclusion; or topical controlled delivery contraceptives (patch) for 3 months prior to inclusion.\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial. ","FSH",null,"Protein","Ovary","Actual","2018-01-30","Actual","Anticipated","2018-03-01","Anticipated","2018-01-01","2018-01-18","2018-01-23","2018-01-23","No",null,"Interventional","Basic Science","Single Group Assignment","None (Open Label)","N/A","18 Years","55 Years","All",null,"Yes","Yes\nQualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://www.clinicalstudydatarequest.com/",{"$nulls":3},"No","No",{"$nulls":4},"No",{"$nulls":12},"2017-002650-37|U1111-1196-5355","UTN","Assessment of PK parameter: AUCtau","Sotagliflozin with ramipril: Area under the curve (AUC) to the end of the dosing period (AUCtau)|Sotagliflozin without ramipril: AUCtau","On Day 10 (Period 2)|On Day 5 (Period 1)","Assessment of PK parameter: Cmax|Assessment of PK parameter: tmax|Adverse events","Sotagliflozin with ramipril: Maximum plasma concentration (Cmax)|Sotagliflozin without ramipril: Cmax|Sotagliflozin with ramipril: Time to reach Cmax (tmax)|Sotagliflozin without ramipril: tmax|Number of adverse events","On Day 10 (Period 2)|On Day 5 (Period 1)|Up to Day 37","Contact-Us@sanofi.com","For site information, send an email with site number to",null,"Berlin, Germany, 14050",null,"Germany","Investigational Site Number 2760001",{"$nulls":3},"Clinical Sciences & Operations","2018-01-23","2020-05-25T16:39:15.049","2020-05-26T17:10:42.972","NCT03414723"]
["5ecbf4b2fe30261b1a04839b","NCT03414723","2018-03-09","Sanofi","SNY","Recruiting","A Drug-Drug Interaction Study Between Sotagliflozin and Ramipril","Sotagliflozin|Ramipril","SGLT1 Inhibitor|SGLT2 Inhibitor|ACE Inhibitor","Yes","['Sotagliflozin']","Yes","['SGLT1 Inhibitor']","Phase 1",1,16,"Anticipated","2018-01-15","2018-03-01","AUC","Area Under The Curve",{"$nulls":3},"Primary Objective:\n\nTo evaluate the effects of multiple-dose ramipril on the steady state pharmacokinetic (PK) parameters of sotagliflozin and its main metabolite (sotagliflozin-3-O-glucuronide) in healthy male and female subjects.\n\nSecondary Objectives:\n\n * To assess the effects of multiple-dose sotagliflozin on the PK of ramipril and its active metabolite (ramiprilat).\n * To assess the safety and tolerability of multiple-dose sotagliflozin with and without multiple-dose of ramipril.","The expected duration of subject participation, including Screening of up to 29 days, Treatment Periods of 6 days and 11 days each with a Washout period of minimum of 7 days in between periods, Follow-up period of 6 days, and end-of-study-period of 10-14 days after last sotagliflozin dose, is approximately 66 days.","An Open Label, 2-treatment, 2-period, Single Sequence Study to Evaluate Pharmacokinetic Drug-drug Interaction Between Ramipril and Sotagliflozin at Steady State in Healthy Subjects","INT14935","Diabetes Mellitus\nHealthy Subjects","Healthy Volunteers|General Diabetes","Healthy|Metabolic Diseases","Healthy|Nutritional Disorders","Experimental","SAR439954 with or without ramipril",null,"Drug","Sotagliflozin (SAR439954)|Ramipril",null,null,"SAR439954 with or without ramipril"," * Healthy male or female subjects, between 18 and 55 years of age, inclusive.\n * Body weight between 50.0 and 100.0 kg, inclusive, if male, and between 40.0 and 90.0 kg, inclusive, if female, body mass index between 18.0 and 32.0 kg/mÂ², inclusive.\n * Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination).\n * Normal vital signs after 10 minutes resting in supine position:\n * 100 mmHg <systolic blood pressure (SBP) <140 mmHg,\n * 60 mmHg <diastolic blood pressure (DBP) <90 mmHg,\n * 50 bpm <heart rate (HR) <90 bpm.\n * Standard 12-lead electrocardiogram (ECG) parameters after 10 minutes resting in supine position in the following ranges; 120 ms<PR<200 ms, QRS <120 ms, QTc â‰¤430 ms if male and QTc â‰¤450 ms if female with normal ECG tracing unless the Investigator considers an ECG tracing abnormality to be not clinically relevant.\n * Laboratory parameters within the normal range, unless the Investigator considers an abnormality to be clinically irrelevant for healthy subjects; however serum creatinine, alkaline phosphatase, hepatic enzymes (aspartate aminotransferase, alanine aminotransferase) should be strictly below the ULN. Total bilirubin out of normal range can be acceptable if total bilirubin should not exceed 1.5 the upper limit with normal conjugated bilirubin values (unless the subject has documented Gilbert syndrome).\n * Female subject must use a double contraception method including a highly effective method of birth control except if she has undergone sterilization at least 3 months earlier or is postmenopausal. The accepted double contraception methods include the use of 1 of the following contraceptive options: (1) intrauterine device; (2) condom or diaphragm or cervical/vault cap, in addition to spermicide. Menopause is defined as being amenorrheic for at least 2 years with plasma follicle stimulating hormone (FSH) value being within the normal range for postmenopausal women according to the local laboratory. Hormonal contraception is NOT acceptable in this study due to drug interaction.\n * Having given written informed consent prior to undertaking any study-related procedure.\n\n"," * Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, or infectious disease, or signs of acute illness.\n * History of renal disease, or significant abnormal kidney function test with glomerular filtration rate (GFR) <90 mL/min as calculated using the Cockcroft-Gault equation.\n * Frequent headaches and/or migraine, recurrent nausea and/or vomiting (more than twice a month).\n * Blood donation, any volume, within 2 months before inclusion.\n * Symptomatic postural hypotension, irrespective of the decrease in blood pressure, or asymptomatic postural hypotension defined as a decrease in systolic blood pressure â‰¥20 mmHg within 3 minutes when changing from supine to standing position.\n * Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician.\n * History or presence of drug or alcohol abuse (alcohol consumption more than 40 g per day on a regular basis).\n * Smoking more than 5 cigarettes or equivalent per day, unable to stop smoking during the study.\n * Excessive consumption of beverages containing xanthine bases (more than 4 cups or glasses per day)\n * If female, pregnancy (defined as positive Î²-HCG blood test if applicable), breast-feeding.\n * Any medication (including St John's Wort) within 14 days before inclusion or within 5 times the elimination half-life or pharmacodynamic half-life of the medication; any vaccination within the last 28 days and any biologics (antibody or its derivatives) given within 4 months before inclusion. Any oral contraceptives during the screening period or for at least 15 days prior to inclusion; any injectable contraceptives or hormonal intrauterine devices within 12 months prior to inclusion; or topical controlled delivery contraceptives (patch) for 3 months prior to inclusion.\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial. ","FSH",null,"Protein","Ovary","Actual","2018-01-30","Actual","Anticipated","2018-03-01","Anticipated","2018-03-01","2018-01-18","2018-01-23","2018-03-08","No",null,"Interventional","Basic Science","Single Group Assignment","None (Open Label)","N/A","18 Years","55 Years","All",null,"Yes","Yes\nQualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://www.clinicalstudydatarequest.com/",{"$nulls":3},"No","No",{"$nulls":4},"No",{"$nulls":12},"2017-002650-37|U1111-1196-5355","UTN","Assessment of PK parameter: AUCtau","Sotagliflozin with ramipril: Area under the curve (AUC) to the end of the dosing period (AUCtau)|Sotagliflozin without ramipril: AUCtau","On Day 10 (Period 2)|On Day 5 (Period 1)","Assessment of PK parameter: Cmax|Assessment of PK parameter: tmax|Adverse events","Sotagliflozin with ramipril: Maximum plasma concentration (Cmax)|Sotagliflozin without ramipril: Cmax|Sotagliflozin with ramipril: Time to reach Cmax (tmax)|Sotagliflozin without ramipril: tmax|Number of adverse events","On Day 10 (Period 2)|On Day 5 (Period 1)|Up to Day 37","Contact-Us@sanofi.com","For site information, send an email with site number to",null,"Berlin, Germany, 14050",null,"Germany","Investigational Site Number 2760001",{"$nulls":3},"Clinical Sciences & Operations","2018-03-08","2020-05-25T16:39:14.495","2020-05-26T17:10:42.972","NCT03414723"]
["5ecbf4b211702c1b1b916ba7","NCT03414723","2018-03-30","Sanofi","SNY","Completed","A Drug-Drug Interaction Study Between Sotagliflozin and Ramipril","Sotagliflozin|Ramipril","SGLT1 Inhibitor|SGLT2 Inhibitor|ACE Inhibitor","Yes","['Sotagliflozin']","Yes","['SGLT1 Inhibitor']","Phase 1",1,1,"Actual","2018-01-15","2018-03-10","AUC","Area Under The Curve",{"$nulls":3},"Primary Objective:\n\nTo evaluate the effects of multiple-dose ramipril on the steady state pharmacokinetic (PK) parameters of sotagliflozin and its main metabolite (sotagliflozin-3-O-glucuronide) in healthy male and female subjects.\n\nSecondary Objectives:\n\n * To assess the effects of multiple-dose sotagliflozin on the PK of ramipril and its active metabolite (ramiprilat).\n * To assess the safety and tolerability of multiple-dose sotagliflozin with and without multiple-dose of ramipril.","The expected duration of subject participation, including Screening of up to 29 days, Treatment Periods of 6 days and 11 days each with a Washout period of minimum of 7 days in between periods, Follow-up period of 6 days, and end-of-study-period of 10-14 days after last sotagliflozin dose, is approximately 66 days.","An Open Label, 2-treatment, 2-period, Single Sequence Study to Evaluate Pharmacokinetic Drug-drug Interaction Between Ramipril and Sotagliflozin at Steady State in Healthy Subjects","INT14935","Diabetes Mellitus\nHealthy Subjects","Healthy Volunteers|General Diabetes","Healthy|Metabolic Diseases","Healthy|Nutritional Disorders","Experimental","SAR439954 with or without ramipril",null,"Drug","Sotagliflozin (SAR439954)|Ramipril",null,null,"SAR439954 with or without ramipril"," * Healthy male or female subjects, between 18 and 55 years of age, inclusive.\n * Body weight between 50.0 and 100.0 kg, inclusive, if male, and between 40.0 and 90.0 kg, inclusive, if female, body mass index between 18.0 and 32.0 kg/mÂ², inclusive.\n * Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination).\n * Normal vital signs after 10 minutes resting in supine position:\n * 100 mmHg <systolic blood pressure (SBP) <140 mmHg,\n * 60 mmHg <diastolic blood pressure (DBP) <90 mmHg,\n * 50 bpm <heart rate (HR) <90 bpm.\n * Standard 12-lead electrocardiogram (ECG) parameters after 10 minutes resting in supine position in the following ranges; 120 ms<PR<200 ms, QRS <120 ms, QTc â‰¤430 ms if male and QTc â‰¤450 ms if female with normal ECG tracing unless the Investigator considers an ECG tracing abnormality to be not clinically relevant.\n * Laboratory parameters within the normal range, unless the Investigator considers an abnormality to be clinically irrelevant for healthy subjects; however serum creatinine, alkaline phosphatase, hepatic enzymes (aspartate aminotransferase, alanine aminotransferase) should be strictly below the ULN. Total bilirubin out of normal range can be acceptable if total bilirubin should not exceed 1.5 the upper limit with normal conjugated bilirubin values (unless the subject has documented Gilbert syndrome).\n * Female subject must use a double contraception method including a highly effective method of birth control except if she has undergone sterilization at least 3 months earlier or is postmenopausal. The accepted double contraception methods include the use of 1 of the following contraceptive options: (1) intrauterine device; (2) condom or diaphragm or cervical/vault cap, in addition to spermicide. Menopause is defined as being amenorrheic for at least 2 years with plasma follicle stimulating hormone (FSH) value being within the normal range for postmenopausal women according to the local laboratory. Hormonal contraception is NOT acceptable in this study due to drug interaction.\n * Having given written informed consent prior to undertaking any study-related procedure.\n\n"," * Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, or infectious disease, or signs of acute illness.\n * History of renal disease, or significant abnormal kidney function test with glomerular filtration rate (GFR) <90 mL/min as calculated using the Cockcroft-Gault equation.\n * Frequent headaches and/or migraine, recurrent nausea and/or vomiting (more than twice a month).\n * Blood donation, any volume, within 2 months before inclusion.\n * Symptomatic postural hypotension, irrespective of the decrease in blood pressure, or asymptomatic postural hypotension defined as a decrease in systolic blood pressure â‰¥20 mmHg within 3 minutes when changing from supine to standing position.\n * Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician.\n * History or presence of drug or alcohol abuse (alcohol consumption more than 40 g per day on a regular basis).\n * Smoking more than 5 cigarettes or equivalent per day, unable to stop smoking during the study.\n * Excessive consumption of beverages containing xanthine bases (more than 4 cups or glasses per day)\n * If female, pregnancy (defined as positive Î²-HCG blood test if applicable), breast-feeding.\n * Any medication (including St John's Wort) within 14 days before inclusion or within 5 times the elimination half-life or pharmacodynamic half-life of the medication; any vaccination within the last 28 days and any biologics (antibody or its derivatives) given within 4 months before inclusion. Any oral contraceptives during the screening period or for at least 15 days prior to inclusion; any injectable contraceptives or hormonal intrauterine devices within 12 months prior to inclusion; or topical controlled delivery contraceptives (patch) for 3 months prior to inclusion.\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial. ","FSH",null,"Protein","Ovary","Actual","2018-01-30","Actual","Actual","2018-03-10","Actual","2018-03-01","2018-01-18","2018-01-23","2018-03-29","No",null,"Interventional","Basic Science","Single Group Assignment","None (Open Label)","N/A","18 Years","55 Years","All",null,"Yes","Yes\nQualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://www.clinicalstudydatarequest.com/",{"$nulls":3},"No","No",{"$nulls":4},"No",{"$nulls":12},"2017-002650-37|U1111-1196-5355","UTN","Assessment of PK parameter: AUCtau","Sotagliflozin with ramipril: Area under the curve (AUC) to the end of the dosing period (AUCtau)|Sotagliflozin without ramipril: AUCtau","On Day 10 (Period 2)|On Day 5 (Period 1)","Assessment of PK parameter: Cmax|Assessment of PK parameter: tmax|Adverse events","Sotagliflozin with ramipril: Maximum plasma concentration (Cmax)|Sotagliflozin without ramipril: Cmax|Sotagliflozin with ramipril: Time to reach Cmax (tmax)|Sotagliflozin without ramipril: tmax|Number of adverse events","On Day 10 (Period 2)|On Day 5 (Period 1)|Up to Day 37",{"$nulls":3},"Berlin, Germany, 14050",null,"Germany","Investigational Site Number 2760001",{"$nulls":3},"Clinical Sciences & Operations","2018-03-29","2020-05-25T16:39:14.760","2020-05-26T17:10:42.972","NCT03414723"]
["5ecbf4b3fe30261b1a04839c","NCT03414736","2018-02-09","Sanofi","SNY","Recruiting","A Study on Safety and Tolerability of SAR425899 in Overweight to Obese Subjects and Type 2 Diabetes Mellitus Patients Not Requiring Anti-Diabetic Pharmacotherapy","Sar-425899",null,"Yes","['Sar-425899']","Unknown",null,"Phase 1",3,60,"Anticipated","2018-01-19","2018-05-01",{"$nulls":5},"Primary Objectives:\n\nTo assess in overweight to obese subjects and type 2 diabetes mellitus (T2DM) patients not requiring anti-diabetic pharmacotherapy the safety and tolerability of 3 different dose escalation regimens of SAR425899 in terms of the relative and absolute frequency and severity of gastrointestinal (GI) adverse events.\n\nSecondary Objectives:\n\nTo assess in overweight to obese subjects and T2DM patients not requiring anti-diabetic pharmacotherapy:\n\n * The effect of once-daily dosing of SAR425899 on body weight (BW), fasting plasma glucose (FPG), and hemoglobin A1c (HbA1c).\n * Safety and tolerability.","The maximum study duration is approximately 12 weeks per patient (up-to 3-week screening period, 8-week treatment period, 3-day post treatment follow-up period).","A Randomized, Comparative, Open Label Study to Assess the Safety and Tolerability of 3-arm, Parallel, Repeated Subcutaneous Dose Regimens of SAR425899 in Overweight to Obese Subjects and T2DM Patients Not Requiring Anti-diabetic Pharmacotherapy","TDR15516","Type 2 Diabetes Mellitus","Type 2 Diabetes","Metabolic Diseases","Nutritional Disorders","Experimental","Cohort 1|Cohort 2|Cohort 3","Daily dose escalation (click-by-click): Starting at dose 1 in the morning with daily increments to dose 2. During the escalation phase, the dose will only be increased if the patient is feeling fine.|Weekly dose escalation in 6 escalation steps (7 dose levels): Starting at dose 1 injected in the morning with weekly increments to dose 2. In case a dose level is not well tolerated by a patient, the treatment should continue at the same dose level for another 7 days before the next dose escalation.|Weekly dose escalation in 4 escalation steps (5 dose levels): Starting at dose 3 with weekly increments to dose 2. In case a dose level is not well tolerated by a patient, the treatment should continue at the same dose level for another 7 days before the next dose escalation.","Drug","SAR425899",null,null,"Cohort 1|Cohort 2|Cohort 3"," * Male or female overweight to obese subjects and type 2 diabetes mellitus (T2DM) patients not requiring anti-diabetic pharmacotherapy.\n * Patients who are motivated to lose weight.\n\n"," * Type 1 diabetes mellitus.\n * Body mass index <27 kg/m2.\n * Screening hemoglobin A1c (HbA1c; glycosylated hemoglobin) >7.0%.\n * Previous treatment with glucose-lowering agent(s) (eg, insulin, thiazolidinediones, metformin, DPP-IV inhibitors (dipeptidylpeptidase 4), SGLT-2 (sodium dependent glucose transporter-2) inhibitors, etc) within the last 6 months.\n * Previous treatment with glucagon-like peptide 1 (GLP-1) receptor agonists within the last 6 months.\n * Uncontrolled hypertension.\n * Laboratory findings at the time of screening: amylase and/or lipase >2 times the upper limit of the normal laboratory range (ULN), alanine aminotransferase >1.5 ULN, total bilirubin >1.5 ULN, serum creatinine levels â‰¥1.5 mg/dL males. â‰¥1.4 mg/dL ",{"$nulls":4},"Actual","2018-01-30","Actual","Anticipated","2018-05-01","Anticipated","2018-02-01","2018-01-17","2018-01-23","2018-02-08","No",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years","75 Years","All",null,"No","Yes\nQualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://www.clinicalstudydatarequest.com/",{"$nulls":3},"Yes","No",{"$nulls":17},"U1111-1205-1368","UTN","Frequency of gastrointestinal (GI) adverse events (AEs)","Relative frequency of GI AEs|Absolute frequency of GI AEs|Severity of GI AEs","Up to week 8","Change in body weight|Change in fasting plasma glucose (FPG)|Change in hemoglobin A1c (HbA1c)|Adverse events (AEs)","Change in body weight from baseline to Week 8|Change in FPG from baseline to Week 8|Change in HbA1c from baseline to Week 8|Number of AEs","Baseline (D1) to week 8|Up to week 12","Contact-Us@sanofi.com","For site information, send an email with site number to",null,"Saint Paul, Minnesota, United States, 55144|Knoxville, Tennessee, United States, 37920|Austin, Texas, United States, 78744","Minnesota|Tennessee|Texas","United States","Investigational Site Number 8400002|Investigational Site Number 8400003|Investigational Site Number 8400001",{"$nulls":3},"Clinical Sciences & Operations","2018-02-08","2020-05-25T16:39:15.191","2020-05-26T17:10:42.972","NCT03414736"]
["5ecbf4b311702c1b1b916ba8","NCT03414736","2018-03-23","Sanofi","SNY","Recruiting","A Study on Safety and Tolerability of SAR425899 in Overweight to Obese Subjects and Type 2 Diabetes Mellitus Patients Not Requiring Anti-Diabetic Pharmacotherapy","Sar-425899",null,"Yes","['Sar-425899']","Unknown",null,"Phase 1",3,60,"Anticipated","2018-01-19","2018-10-11",{"$nulls":5},"Primary Objectives:\n\nTo assess in overweight to obese subjects and type 2 diabetes mellitus (T2DM) patients not requiring anti-diabetic pharmacotherapy the safety and tolerability of 3 different dose escalation regimens of SAR425899 in terms of the relative and absolute frequency and severity of gastrointestinal (GI) adverse events.\n\nSecondary Objectives:\n\nTo assess in overweight to obese subjects and T2DM patients not requiring anti-diabetic pharmacotherapy:\n\n * The effect of once-daily dosing of SAR425899 on body weight (BW), fasting plasma glucose (FPG), and hemoglobin A1c (HbA1c).\n * Safety and tolerability.","The maximum study duration is approximately 12 weeks per patient (up-to 3-week screening period, 8-week treatment period, 3-day post treatment follow-up period).","A Randomized, Comparative, Open Label Study to Assess the Safety and Tolerability of 3-arm, Parallel, Repeated Subcutaneous Dose Regimens of SAR425899 in Overweight to Obese Subjects and T2DM Patients Not Requiring Anti-diabetic Pharmacotherapy","TDR15516","Type 2 Diabetes Mellitus","Type 2 Diabetes","Metabolic Diseases","Nutritional Disorders","Experimental","Cohort 1|Cohort 2|Cohort 3","Daily dose escalation (click-by-click): Starting at dose 1 in the morning with daily increments to dose 2. During the escalation phase, the dose will only be increased if the patient is feeling fine.|Weekly dose escalation in 6 escalation steps (7 dose levels): Starting at dose 1 injected in the morning with weekly increments to dose 2. In case a dose level is not well tolerated by a patient, the treatment should continue at the same dose level for another 7 days before the next dose escalation.|Weekly dose escalation in 4 escalation steps (5 dose levels): Starting at dose 3 with weekly increments to dose 2. In case a dose level is not well tolerated by a patient, the treatment should continue at the same dose level for another 7 days before the next dose escalation.","Drug","SAR425899",null,null,"Cohort 1|Cohort 2|Cohort 3"," * Male or female overweight to obese subjects and type 2 diabetes mellitus (T2DM) patients not requiring anti-diabetic pharmacotherapy.\n * Patients who are motivated to lose weight.\n\n"," * Type 1 diabetes mellitus.\n * Body mass index <27 kg/m2.\n * Screening hemoglobin A1c (HbA1c; glycosylated hemoglobin) >7.0%.\n * Previous treatment with glucose-lowering agent(s) (eg, insulin, thiazolidinediones, metformin, DPP-IV inhibitors (dipeptidylpeptidase 4), SGLT-2 (sodium dependent glucose transporter-2) inhibitors, etc) within the last 6 months.\n * Previous treatment with glucagon-like peptide 1 (GLP-1) receptor agonists within the last 6 months.\n * Uncontrolled hypertension.\n * Laboratory findings at the time of screening: amylase and/or lipase >2 times the upper limit of the normal laboratory range (ULN), alanine aminotransferase >1.5 ULN, total bilirubin >1.5 ULN, serum creatinine levels â‰¥1.5 mg/dL males. â‰¥1.4 mg/dL ",{"$nulls":4},"Actual","2018-01-30","Actual","Anticipated","2018-10-11","Anticipated","2018-03-01","2018-01-17","2018-01-23","2018-03-22","No",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years","75 Years","All",null,"No","Yes\nQualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://www.clinicalstudydatarequest.com/",{"$nulls":3},"Yes","No",{"$nulls":17},"U1111-1205-1368","UTN","Frequency of gastrointestinal (GI) adverse events (AEs)","Relative frequency of GI AEs|Absolute frequency of GI AEs|Severity of GI AEs","Up to week 8","Change in body weight|Change in fasting plasma glucose (FPG)|Change in hemoglobin A1c (HbA1c)|Adverse events (AEs)","Change in body weight from baseline to Week 8|Change in FPG from baseline to Week 8|Change in HbA1c from baseline to Week 8|Number of AEs","Baseline (D1) to week 8|Up to week 12","Contact-Us@sanofi.com","For site information, send an email with site number to",null,"Saint Paul, Minnesota, United States, 55144|Knoxville, Tennessee, United States, 37920|Austin, Texas, United States, 78744","Minnesota|Tennessee|Texas","United States","Investigational Site Number 8400002|Investigational Site Number 8400003|Investigational Site Number 8400001",{"$nulls":3},"Clinical Sciences & Operations","2018-03-22","2020-05-25T16:39:15.149","2020-05-26T17:10:42.972","NCT03414736"]
["5ecbf4b311702c1b1b916ba9","NCT03414736","2018-04-12","Sanofi","SNY","Recruiting","A Study on Safety and Tolerability of SAR425899 in Overweight to Obese Subjects and Type 2 Diabetes Mellitus Patients Not Requiring Anti-Diabetic Pharmacotherapy With an Optional 6-month Safety Extension Period","Sar-425899",null,"Yes","['Sar-425899']","Unknown",null,"Phase 1",3,60,"Anticipated","2018-01-19","2018-10-01",{"$nulls":5},"Primary Objectives:\n\n * Main study: To assess in overweight to obese subjects and type 2 diabetes mellitus (T2DM) patients not requiring anti-diabetic pharmacotherapy the safety and tolerability of 3 different dose escalation regimens of SAR425899 in terms of the relative and absolute frequency and severity of gastrointestinal (GI) adverse events (AEs).\n * Six-month safety extension period: To assess the safety and tolerability of SAR425899 after 6 months treatment at the maximum dose that was individually well tolerated during the main part of the study in terms of the relative and absolute frequency and severity of GI AEs.\n\nSecondary Objectives:\n\nMain study and 6-month study extension period:\n\nTo assess in overweight to obese subjects and T2DM patients not requiring anti-diabetic pharmacotherapy:\n\n * The effect of once-daily dosing of SAR425899 on body weight (BW), fasting plasma glucose (FPG), and hemoglobin A1c (HbA1c).\n * Safety and tolerability.","Main study: The maximum study duration is approximately 12 weeks per patient (up-to 3-week screening period, 8-week treatment period, 3-day post treatment follow-up period).\n\nSix-month study extension period: The maximum study duration is approximately 9 months (up-to 3-week screening period, 8-month treatment period, 3-day post treatment follow-up period).","A Randomized, Comparative, Open Label Study to Assess the Safety and Tolerability of 3-arm, Parallel, Repeated Subcutaneous Dose Regimens of SAR425899 in Overweight to Obese Subjects and T2DM Patients Not Requiring Anti-diabetic Pharmacotherapy, With an Optional 6-month Safety Extension Period","TDR15516","Type 2 Diabetes Mellitus","Type 2 Diabetes","Metabolic Diseases","Nutritional Disorders","Experimental","Cohort 1|Cohort 2|Cohort 3","Daily dose escalation (click-by-click): Starting at dose 1 in the morning with daily increments to dose 2. During the escalation phase, the dose will only be increased if the patient is feeling fine.|Weekly dose escalation in 6 escalation steps (7 dose levels): Starting at dose 1 injected in the morning with weekly increments to dose 2. In case a dose level is not well tolerated by a patient, the treatment should continue at the same dose level for another 7 days before the next dose escalation.|Weekly dose escalation in 4 escalation steps (5 dose levels): Starting at dose 3 with weekly increments to dose 2. In case a dose level is not well tolerated by a patient, the treatment should continue at the same dose level for another 7 days before the next dose escalation.","Drug","SAR425899",null,null,"Cohort 1|Cohort 2|Cohort 3"," * Male or female overweight to obese subjects and type 2 diabetes mellitus (T2DM) patients not requiring anti-diabetic pharmacotherapy.\n * Patients who are motivated to lose weight.\n\n"," * Type 1 diabetes mellitus.\n * Body mass index <27 kg/m2.\n * Screening hemoglobin A1c (HbA1c; glycosylated hemoglobin) >7.0%.\n * Previous treatment with glucose-lowering agent(s) (eg, insulin, thiazolidinediones, metformin, DPP-IV inhibitors (dipeptidylpeptidase 4), SGLT-2 (sodium dependent glucose transporter-2) inhibitors, etc) within the last 6 months.\n * Previous treatment with glucagon-like peptide 1 (GLP-1) receptor agonists within the last 6 months.\n * Uncontrolled hypertension.\n * Laboratory findings at the time of screening: amylase and/or lipase >2 times the upper limit of the normal laboratory range (ULN), alanine aminotransferase >1.5 ULN, total bilirubin >1.5 ULN, serum creatinine levels â‰¥1.5 mg/dL males. â‰¥1.4 mg/dL ",{"$nulls":4},"Actual","2018-01-30","Actual","Anticipated","2018-10-01","Anticipated","2018-04-01","2018-01-17","2018-01-23","2018-04-11","No",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years","75 Years","All",null,"No","Yes\nQualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://www.clinicalstudydatarequest.com/",{"$nulls":3},"Yes","No",{"$nulls":17},"U1111-1205-1368","UTN","Frequency of gastrointestinal (GI) adverse events (AEs)|Frequency of GI AEs","Relative frequency of GI AEs|Absolute frequency of GI AEs|Severity of GI AEs","Main study: Up to week 8; Six-month study extension period: Up to month 8","Change in body weight|Change in fasting plasma glucose (FPG)|Change in hemoglobin A1c (HbA1c)|Adverse events (AEs)","Change in body weight from baseline to week 8 for the main study and from baseline to month 8 for the study extension period.|Change in FPG from baseline to week 8 for the main study and from baseline to month 8 for the study extension period.|Change in HbA1c from baseline to week 8 for the main study and from baseline to month 8 for the study extension period.|Number of AEs","Main study: Baseline (D1) to week 8; Six-month study extension period: Baseline (D1) up to month 8|Main study: up to week 8; Six-month extension period: up to month 8","Contact-Us@sanofi.com","For site information, send an email with site number to",null,"[Active, Not Recruiting]Saint Paul, Minnesota, United States, 55144|[Active, Not Recruiting]Knoxville, Tennessee, United States, 37920|Austin, Texas, United States, 78744","Minnesota|Tennessee|Texas","United States","Investigational Site Number 8400002|Investigational Site Number 8400003|Investigational Site Number 8400001",{"$nulls":3},"Clinical Sciences & Operations","2018-04-11","2020-05-25T16:39:15.297","2020-05-26T17:10:42.972","NCT03414736"]
["5ecbf4b3e2561b1b11905e97","NCT03414736","2018-05-16","Sanofi","SNY","Active, not recruiting","A Study on Safety and Tolerability of SAR425899 in Overweight to Obese Subjects and Type 2 Diabetes Mellitus Patients Not Requiring Anti-Diabetic Pharmacotherapy With an Optional 6-month Safety Extension Period","Sar-425899",null,"Yes","['Sar-425899']","Unknown",null,"Phase 1",3,60,"Actual","2018-01-19","2018-10-01",{"$nulls":5},"Primary Objectives:\n\n * Main study: To assess in overweight to obese subjects and type 2 diabetes mellitus (T2DM) patients not requiring anti-diabetic pharmacotherapy the safety and tolerability of 3 different dose escalation regimens of SAR425899 in terms of the relative and absolute frequency and severity of gastrointestinal (GI) adverse events (AEs).\n * Six-month safety extension period: To assess the safety and tolerability of SAR425899 after 6 months treatment at the maximum dose that was individually well tolerated during the main part of the study in terms of the relative and absolute frequency and severity of GI AEs.\n\nSecondary Objectives:\n\nMain study and 6-month study extension period:\n\nTo assess in overweight to obese subjects and T2DM patients not requiring anti-diabetic pharmacotherapy:\n\n * The effect of once-daily dosing of SAR425899 on body weight (BW), fasting plasma glucose (FPG), and hemoglobin A1c (HbA1c).\n * Safety and tolerability.","Main study: The maximum study duration is approximately 12 weeks per patient (up-to 3-week screening period, 8-week treatment period, 3-day post treatment follow-up period).\n\nSix-month study extension period: The maximum study duration is approximately 9 months (up-to 3-week screening period, 8-month treatment period, 3-day post treatment follow-up period).","A Randomized, Comparative, Open Label Study to Assess the Safety and Tolerability of 3-arm, Parallel, Repeated Subcutaneous Dose Regimens of SAR425899 in Overweight to Obese Subjects and T2DM Patients Not Requiring Anti-diabetic Pharmacotherapy, With an Optional 6-month Safety Extension Period","TDR15516","Type 2 Diabetes Mellitus","Type 2 Diabetes","Metabolic Diseases","Nutritional Disorders","Experimental","Cohort 1|Cohort 2|Cohort 3","Daily dose escalation (click-by-click): Starting at dose 1 in the morning with daily increments to dose 2. During the escalation phase, the dose will only be increased if the patient is feeling fine.|Weekly dose escalation in 6 escalation steps (7 dose levels): Starting at dose 1 injected in the morning with weekly increments to dose 2. In case a dose level is not well tolerated by a patient, the treatment should continue at the same dose level for another 7 days before the next dose escalation.|Weekly dose escalation in 4 escalation steps (5 dose levels): Starting at dose 3 with weekly increments to dose 2. In case a dose level is not well tolerated by a patient, the treatment should continue at the same dose level for another 7 days before the next dose escalation.","Drug","SAR425899",null,null,"Cohort 1|Cohort 2|Cohort 3"," * Male or female overweight to obese subjects and type 2 diabetes mellitus (T2DM) patients not requiring anti-diabetic pharmacotherapy.\n * Patients who are motivated to lose weight.\n\n"," * Type 1 diabetes mellitus.\n * Body mass index <27 kg/m2.\n * Screening hemoglobin A1c (HbA1c; glycosylated hemoglobin) >7.0%.\n * Previous treatment with glucose-lowering agent(s) (eg, insulin, thiazolidinediones, metformin, DPP-IV inhibitors (dipeptidylpeptidase 4), SGLT-2 (sodium dependent glucose transporter-2) inhibitors, etc) within the last 6 months.\n * Previous treatment with glucagon-like peptide 1 (GLP-1) receptor agonists within the last 6 months.\n * Uncontrolled hypertension.\n * Laboratory findings at the time of screening: amylase and/or lipase >2 times the upper limit of the normal laboratory range (ULN), alanine aminotransferase >1.5 ULN, total bilirubin >1.5 ULN, serum creatinine levels â‰¥1.5 mg/dL males. â‰¥1.4 mg/dL ",{"$nulls":4},"Actual","2018-01-30","Actual","Anticipated","2018-10-01","Anticipated","2018-05-01","2018-01-17","2018-01-23","2018-05-15","No",null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years","75 Years","All",null,"No","Yes\nQualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://www.clinicalstudydatarequest.com/",{"$nulls":3},"Yes","No",{"$nulls":17},"U1111-1205-1368","UTN","Frequency of gastrointestinal (GI) adverse events (AEs)|Frequency of GI AEs","Relative frequency of GI AEs|Absolute frequency of GI AEs|Severity of GI AEs","Main study: Up to week 8; Six-month study extension period: Up to month 8","Change in body weight|Change in fasting plasma glucose (FPG)|Change in hemoglobin A1c (HbA1c)|Adverse events (AEs)","Change in body weight from baseline to week 8 for the main study and from baseline to month 8 for the study extension period.|Change in FPG from baseline to week 8 for the main study and from baseline to month 8 for the study extension period.|Change in HbA1c from baseline to week 8 for the main study and from baseline to month 8 for the study extension period.|Number of AEs","Main study: Baseline (D1) to week 8; Six-month study extension period: Baseline (D1) up to month 8|Main study: up to week 8; Six-month extension period: up to month 8",{"$nulls":3},"Saint Paul, Minnesota, United States, 55144|Knoxville, Tennessee, United States, 37920|Austin, Texas, United States, 78744","Minnesota|Tennessee|Texas","United States","Investigational Site Number 8400002|Investigational Site Number 8400003|Investigational Site Number 8400001",{"$nulls":3},"Clinical Sciences & Operations","2018-05-15","2020-05-25T16:39:15.806","2020-05-26T17:10:42.972","NCT03414736"]
["5ecbf4b3fe30261b1a04839e","NCT03414788","2018-02-09","Pfizer","PFE","Not yet recruiting","Distribution of a Single IV Dose Of [124I]-Pf 06687234 and Pf 06687234 Assessed With PET-CT Imaging In Moderate To Severe Ulcerative Colitis","Pf-06687234",null,"Yes","['Pf-06687234']","Unknown",null,"Phase 1",1,5,"Anticipated","2018-02-27","2019-04-21","SUV","Standardized Uptake Value",{"$nulls":3},"The purpose of the study is to evaluate the PK, safety and tolerability of PF-06687234 and [124I]IB-PF-06687234 (simultaneously given) in subjects with moderate to severe Ulcerative Colitis. The study used PET-CT scan imaging to assess the distribution of PF-06687234 and [124I]IB-PF-06687234 over 24 and 72 hours in colon (inflamed and non-inflamed), plasma, colon, liver, spleen, kidney and small intestine.",null,"PHASE 1B, OPEN LABEL STUDY TO CHARACTERIZE THE DISTRIBUTION OF A SINGLE INTRAVENOUS DOSE OF [124I]-IODOBENZOYL (IB) PF 06687234 WITH CONCURRENT ADMINISTRATION OF NON-RADIOLABELED PF 06687234 AS ASSESSED WITH POSITRON EMISSION TOMOGRAPHY AND COMPUTED TOMOGRAPHY (PET-CT) IMAGING IN MODERATE TO SEVERE ULCERATIVE COLITIS SUBJECTS","B7581003","Ulcerative Colitis","Colitis|Colitis, Ulcerative","Gastrointestinal Diseases","Gastrointestinal","Experimental","Treatment Arm - PF 06687234 and [124I]IB PF 06687234","PF 06687234 and [124I]IB PF 06687234","Biological","PF 06687234|[124I]IB PF 06687234","Subjects will be given single, intravenous dose of PF 06687234 and [124I]IB PF 06687234 simultaneously",null,"Treatment Arm - PF 06687234 and [124I]IB PF 06687234","\n\n * Male and/or female subjects of non-child bearing potential, 18 years to 75 years of age inclusive at the time of informed consent\n * Only women of non-child bearing potential\n * Diagnosis of active UC (histologic) prior to study entry for a minimum of 4 months\n * Subjects with moderate to severe, active UC as defined by Mayo stool frequency subscore of > 1, and/or rectal bleeding subscore of > 1\n * Mayo Endoscopic subscore of at least 2 for a portion of inflamed segment\n\n","\n\n * Clinically significant/unstable clinical conditions (eg. cancer hematological, endocrine etc)\n * Active enteric infections\n * Other forms of colitis such as Crohn's disease, infectious colitis etc",{"$nulls":4},"Actual","2018-01-30","Actual","Anticipated","2019-04-21","Anticipated","2018-02-01","2018-01-08","2018-01-26","2018-02-07","No","Positron Emission Tomography (PET), Ulcerative Colitis, Safety, PKPlasma","Interventional","Other","Single Group Assignment","None (Open Label)","N/A","18 Years","75 Years","All",null,"No","No\nInformation relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests",null,"URL: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7581003&StudyName=Phase+1b%2C+Open+Label+Study+To+Characterize+The+Distribution+Of+A+Single+Intravenous+Dose+Of+%5B124i%5D-iodobenzoyl+%28ib%29+Pf+06687234+With+Concurrent+Administration+Of+Non-radiolabeled+Pf+06687234+As+Assessed+With+Positron+Emission+Tomography+And+Computed+Tomography+%28pet-ct%29+Imaging+In+Moderate+To+Severe+Ulcerative+Colitis+Subjects [https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7581003&StudyName=Phase+1b%2C+Open+Label+Study+To+Characterize+The+Distribution+Of+A+Single+Intravenous+Dose+Of+%5B124i%5D-iodobenzoyl+%28ib%29+Pf+06687234+With+Concurrent+Administration+Of+Non-radiolabeled+Pf+06687234+As+Assessed+With+Positron+Emission+Tomography+And+Computed+Tomography+%28pet-ct%29+Imaging+In+Moderate+To+Severe+Ulcerative+Colitis+Subjects] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To obtain contact information for a study center near you, click here.",null,"Yes","No",{"$nulls":19},"Percent injected radioactivity dose per kilogram (% ID/kg) in the colon (inflamed and non inflamed) and plasma|Standardized uptake value (SUV) in the colon (inflamed and non inflamed)","Treatment Arm","24 hours","AUC of PF 06687234 plasma concentrations over time|AUC of plasma radioactivity concentration (% ID/kg)|AUC in plasma, colon, liver, spleen, kidney and small intestine|Ratio of radioactivity AUC0-24H between colon, liver, spleen, kidney and small intestine to plasma|Frequency of clinically relevant abnormalities for Safety Labs|Cmax of PF 06687234 plasma concentrations over time|Tmax of PF 06687234 plasma concentrations over time|Cmax of plasma radioactivity concentration (% ID/kg)|Tmax of plasma radioactivity concentration (% ID/kg)|Cmax of radioactivity in plasma, colon, liver, spleen, kidney and small intestine|Tmax of radioactivity in plasma, colon, liver, spleen, kidney and small intestine|Frequency of clinically relevant abnormalities for vital signs|Frequency of clinically relevant abnormalities for ECG|Frequency of clinically relevant abnormalities for Immunogenicity","Treatment Arm","42 days|24 hours","ClinicalTrials.gov_Inquiries@pfizer.com","Pfizer CT.gov Call Center","1-800-718-1021",{"$nulls":7},"Pfizer CT.gov Call Center","2018-02-07","2020-05-25T16:39:15.676","2020-05-26T17:10:42.972","NCT03414788"]
["5ecbf4b4feab101b155309cd","NCT03414788","2018-03-08","Pfizer","PFE","Not yet recruiting","Distribution of a Single IV Dose Of [124I]-Pf 06687234 and Pf 06687234 Assessed With PET-CT Imaging In Moderate To Severe Ulcerative Colitis","Pf-06687234",null,"Yes","['Pf-06687234']","Unknown",null,"Phase 1",1,5,"Anticipated","2018-03-28","2019-05-20","SUV","Standardized Uptake Value",{"$nulls":3},"The purpose of the study is to evaluate the PK, safety and tolerability of PF-06687234 and [124I]IB-PF-06687234 (simultaneously given) in subjects with moderate to severe Ulcerative Colitis. The study used PET-CT scan imaging to assess the distribution of PF-06687234 and [124I]IB-PF-06687234 over 24 and 72 hours in colon (inflamed and non-inflamed), plasma, colon, liver, spleen, kidney and small intestine.",null,"PHASE 1B, OPEN LABEL STUDY TO CHARACTERIZE THE DISTRIBUTION OF A SINGLE INTRAVENOUS DOSE OF [124I]-IODOBENZOYL (IB) PF 06687234 WITH CONCURRENT ADMINISTRATION OF NON-RADIOLABELED PF 06687234 AS ASSESSED WITH POSITRON EMISSION TOMOGRAPHY AND COMPUTED TOMOGRAPHY (PET-CT) IMAGING IN MODERATE TO SEVERE ULCERATIVE COLITIS SUBJECTS","B7581003","Ulcerative Colitis","Colitis|Colitis, Ulcerative","Gastrointestinal Diseases","Gastrointestinal","Experimental","Treatment Arm - PF 06687234 and [124I]IB PF 06687234","PF 06687234 and [124I]IB PF 06687234","Biological","PF 06687234|[124I]IB PF 06687234","Subjects will be given single, intravenous dose of PF 06687234 and [124I]IB PF 06687234 simultaneously",null,"Treatment Arm - PF 06687234 and [124I]IB PF 06687234","\n\n * Male and/or female subjects of non-child bearing potential, 18 years to 75 years of age inclusive at the time of informed consent\n * Only women of non-child bearing potential\n * Diagnosis of active UC (histologic) prior to study entry for a minimum of 4 months\n * Subjects with moderate to severe, active UC as defined by Mayo stool frequency subscore of > 1, and/or rectal bleeding subscore of > 1\n * Mayo Endoscopic subscore of at least 2 for a portion of inflamed segment\n\n","\n\n * Clinically significant/unstable clinical conditions (eg. cancer hematological, endocrine etc)\n * Active enteric infections\n * Other forms of colitis such as Crohn's disease, infectious colitis etc",{"$nulls":4},"Actual","2018-01-30","Actual","Anticipated","2019-05-20","Anticipated","2018-03-01","2018-01-08","2018-01-26","2018-03-06","No","Positron Emission Tomography (PET), Ulcerative Colitis, Safety, PKPlasma","Interventional","Other","Single Group Assignment","None (Open Label)","N/A","18 Years","75 Years","All",null,"No","No\nInformation relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests",null,"URL: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7581003&StudyName=Phase+1b%2C+Open+Label+Study+To+Characterize+The+Distribution+Of+A+Single+Intravenous+Dose+Of+%5B124i%5D-iodobenzoyl+%28ib%29+Pf+06687234+With+Concurrent+Administration+Of+Non-radiolabeled+Pf+06687234+As+Assessed+With+Positron+Emission+Tomography+And+Computed+Tomography+%28pet-ct%29+Imaging+In+Moderate+To+Severe+Ulcerative+Colitis+Subjects [https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7581003&StudyName=Phase+1b%2C+Open+Label+Study+To+Characterize+The+Distribution+Of+A+Single+Intravenous+Dose+Of+%5B124i%5D-iodobenzoyl+%28ib%29+Pf+06687234+With+Concurrent+Administration+Of+Non-radiolabeled+Pf+06687234+As+Assessed+With+Positron+Emission+Tomography+And+Computed+Tomography+%28pet-ct%29+Imaging+In+Moderate+To+Severe+Ulcerative+Colitis+Subjects] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To obtain contact information for a study center near you, click here.",null,"Yes","No",{"$nulls":19},"Percent injected radioactivity dose per kilogram (% ID/kg) in the colon (inflamed and non inflamed) and plasma|Standardized uptake value (SUV) in the colon (inflamed and non inflamed)","Treatment Arm","24 hours","AUC of PF 06687234 plasma concentrations over time|AUC of plasma radioactivity concentration (% ID/kg)|AUC in plasma, colon, liver, spleen, kidney and small intestine|Ratio of radioactivity AUC0-24H between colon, liver, spleen, kidney and small intestine to plasma|Frequency of clinically relevant abnormalities for Safety Labs|Cmax of PF 06687234 plasma concentrations over time|Tmax of PF 06687234 plasma concentrations over time|Cmax of plasma radioactivity concentration (% ID/kg)|Tmax of plasma radioactivity concentration (% ID/kg)|Cmax of radioactivity in plasma, colon, liver, spleen, kidney and small intestine|Tmax of radioactivity in plasma, colon, liver, spleen, kidney and small intestine|Frequency of clinically relevant abnormalities for vital signs|Frequency of clinically relevant abnormalities for ECG|Frequency of clinically relevant abnormalities for Immunogenicity","Treatment Arm","42 days|24 hours","ClinicalTrials.gov_Inquiries@pfizer.com","Pfizer CT.gov Call Center","1-800-718-1021",{"$nulls":7},"Pfizer CT.gov Call Center","2018-03-06","2020-05-25T16:39:16.278","2020-05-26T17:10:42.972","NCT03414788"]
["5ecbf4b4307e3d1b1f8d9e30","NCT03414788","2018-08-01","Pfizer","PFE","Recruiting","Distribution of a Single IV Dose Of [124I]-Pf 06687234 and Pf 06687234 Assessed With PET-CT Imaging In Moderate To Severe Ulcerative Colitis","Pf-06687234",null,"Yes","['Pf-06687234']","Unknown",null,"Phase 1",1,5,"Anticipated","2018-07-31","2019-09-25","SUV","Standardized Uptake Value",{"$nulls":3},"The purpose of the study is to evaluate the PK, safety and tolerability of PF-06687234 and [124I]IB-PF-06687234 (simultaneously given) in subjects with moderate to severe Ulcerative Colitis. The study used PET-CT scan imaging to assess the distribution of PF-06687234 and [124I]IB-PF-06687234 over 24 and 72 hours in colon (inflamed and non-inflamed), plasma, colon, liver, spleen, kidney and small intestine.",null,"PHASE 1B, OPEN LABEL STUDY TO CHARACTERIZE THE DISTRIBUTION OF A SINGLE INTRAVENOUS DOSE OF [124I]-IODOBENZOYL (IB) PF 06687234 WITH CONCURRENT ADMINISTRATION OF NON-RADIOLABELED PF 06687234 AS ASSESSED WITH POSITRON EMISSION TOMOGRAPHY AND COMPUTED TOMOGRAPHY (PET-CT) IMAGING IN MODERATE TO SEVERE ULCERATIVE COLITIS SUBJECTS","B7581003","Ulcerative Colitis","Colitis|Colitis, Ulcerative","Gastrointestinal Diseases","Gastrointestinal","Experimental","Treatment Arm - PF 06687234 and [124I]IB PF 06687234","PF 06687234 and [124I]IB PF 06687234","Biological","PF 06687234|[124I]IB PF 06687234","Subjects will be given single, intravenous dose of PF 06687234 and [124I]IB PF 06687234 simultaneously",null,"Treatment Arm - PF 06687234 and [124I]IB PF 06687234","\n\n * Male and/or female subjects of non-child bearing potential, 18 years to 75 years of age inclusive at the time of informed consent\n * Only women of non-child bearing potential\n * Diagnosis of active UC (histologic) prior to study entry for a minimum of 4 months\n * Subjects with moderate to severe, active UC as defined by Mayo stool frequency subscore of > 1, and/or rectal bleeding subscore of > 1\n * Mayo Endoscopic subscore of at least 2 for a portion of inflamed segment\n\n","\n\n * Clinically significant/unstable clinical conditions (eg. cancer hematological, endocrine etc)\n * Active enteric infections\n * Other forms of colitis such as Crohn's disease, infectious colitis etc",{"$nulls":4},"Actual","2018-01-30","Actual","Anticipated","2019-09-25","Anticipated","2018-07-01","2018-01-08","2018-01-26","2018-07-30","No","Positron Emission Tomography (PET), Ulcerative Colitis, Safety, PKPlasma","Interventional","Other","Single Group Assignment","None (Open Label)","N/A","18 Years","75 Years","All",null,"No","No\nInformation relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests",null,"URL: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7581003&StudyName=Phase+1b%2C+Open+Label+Study+To+Characterize+The+Distribution+Of+A+Single+Intravenous+Dose+Of+%5B124i%5D-iodobenzoyl+%28ib%29+Pf+06687234+With+Concurrent+Administration+Of+Non-radiolabeled+Pf+06687234+As+Assessed+With+Positron+Emission+Tomography+And+Computed+Tomography+%28pet-ct%29+Imaging+In+Moderate+To+Severe+Ulcerative+Colitis+Subjects [https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7581003&StudyName=Phase+1b%2C+Open+Label+Study+To+Characterize+The+Distribution+Of+A+Single+Intravenous+Dose+Of+%5B124i%5D-iodobenzoyl+%28ib%29+Pf+06687234+With+Concurrent+Administration+Of+Non-radiolabeled+Pf+06687234+As+Assessed+With+Positron+Emission+Tomography+And+Computed+Tomography+%28pet-ct%29+Imaging+In+Moderate+To+Severe+Ulcerative+Colitis+Subjects] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To obtain contact information for a study center near you, click here.",null,"Yes","No",{"$nulls":19},"Percent injected radioactivity dose per kilogram (% ID/kg) in the colon (inflamed and non inflamed) and plasma|Standardized uptake value (SUV) in the colon (inflamed and non inflamed)","Treatment Arm","24 hours","AUC of PF 06687234 plasma concentrations over time|AUC of plasma radioactivity concentration (% ID/kg)|AUC in plasma, colon, liver, spleen, kidney and small intestine|Ratio of radioactivity AUC0-24H between colon, liver, spleen, kidney and small intestine to plasma|Frequency of clinically relevant abnormalities for Safety Labs|Cmax of PF 06687234 plasma concentrations over time|Tmax of PF 06687234 plasma concentrations over time|Cmax of plasma radioactivity concentration (% ID/kg)|Tmax of plasma radioactivity concentration (% ID/kg)|Cmax of radioactivity in plasma, colon, liver, spleen, kidney and small intestine|Tmax of radioactivity in plasma, colon, liver, spleen, kidney and small intestine|Frequency of clinically relevant abnormalities for vital signs|Frequency of clinically relevant abnormalities for ECG|Frequency of clinically relevant abnormalities for Immunogenicity","Treatment Arm","42 days|24 hours","ClinicalTrials.gov_Inquiries@pfizer.com","Pfizer CT.gov Call Center","1-800-718-1021","Guilford, Connecticut, United States, 06437 Endoscopy Center Of Connecticut, LlcHamden, Connecticut, United States, 06518 New Haven Clinical Research UnitNew Haven, Connecticut, United States, 06511 Yale University School Of MedicineNew Haven, Connecticut, United States, 06520","Connecticut","United States","Endoscopy Center Of Connecticut, Llc",{"$nulls":3},"Pfizer CT.gov Call Center","2018-07-30","2020-05-25T16:39:16.302","2020-05-26T17:10:42.972","NCT03414788"]
["5ecbf4b4e2561b1b11905e98","NCT03414788","2018-09-18","Pfizer","PFE","Recruiting","Distribution of a Single IV Dose Of [124I]-Pf 06687234 and Pf 06687234 Assessed With PET-CT Imaging In Moderate To Severe Ulcerative Colitis","Pf-06687234",null,"Yes","['Pf-06687234']","Unknown",null,"Phase 1",1,5,"Anticipated","2018-10-15","2019-12-10","SUV","Standardized Uptake Value",{"$nulls":3},"The purpose of the study is to evaluate the PK, safety and tolerability of PF-06687234 and [124I]IB-PF-06687234 (simultaneously given) in subjects with moderate to severe Ulcerative Colitis. The study used PET-CT scan imaging to assess the distribution of PF-06687234 and [124I]IB-PF-06687234 over 24 and 72 hours in colon (inflamed and non-inflamed), plasma, colon, liver, spleen, kidney and small intestine.",null,"PHASE 1B, OPEN LABEL STUDY TO CHARACTERIZE THE DISTRIBUTION OF A SINGLE INTRAVENOUS DOSE OF [124I]-IODOBENZOYL (IB) PF 06687234 WITH CONCURRENT ADMINISTRATION OF NON-RADIOLABELED PF 06687234 AS ASSESSED WITH POSITRON EMISSION TOMOGRAPHY AND COMPUTED TOMOGRAPHY (PET-CT) IMAGING IN MODERATE TO SEVERE ULCERATIVE COLITIS SUBJECTS","B7581003","Ulcerative Colitis","Colitis|Colitis, Ulcerative","Gastrointestinal Diseases","Gastrointestinal","Experimental","Treatment Arm - PF 06687234 and [124I]IB PF 06687234","PF 06687234 and [124I]IB PF 06687234","Biological","PF 06687234|[124I]IB PF 06687234","Subjects will be given single, intravenous dose of PF 06687234 and [124I]IB PF 06687234 simultaneously",null,"Treatment Arm - PF 06687234 and [124I]IB PF 06687234","\n\n * Male and/or female subjects of non-child bearing potential, 18 years to 75 years of age inclusive at the time of informed consent\n * Only women of non-child bearing potential\n * Diagnosis of active UC (histologic) prior to study entry for a minimum of 4 months\n * Subjects with moderate to severe, active UC as defined by Mayo stool frequency subscore of > 1, and/or rectal bleeding subscore of > 1\n * Mayo Endoscopic subscore of at least 2 for a portion of inflamed segment\n\n","\n\n * Clinically significant/unstable clinical conditions (eg. cancer hematological, endocrine etc)\n * Active enteric infections\n * Other forms of colitis such as Crohn's disease, infectious colitis etc",{"$nulls":4},"Actual","2018-01-30","Actual","Anticipated","2019-12-10","Anticipated","2018-09-01","2018-01-08","2018-01-26","2018-09-17","No","Positron Emission Tomography (PET), Ulcerative Colitis, Safety, PKPlasma","Interventional","Other","Single Group Assignment","None (Open Label)","N/A","18 Years","75 Years","All",null,"No","No\nInformation relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests",null,"URL: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7581003&StudyName=Phase+1b%2C+Open+Label+Study+To+Characterize+The+Distribution+Of+A+Single+Intravenous+Dose+Of+%5B124i%5D-iodobenzoyl+%28ib%29+Pf+06687234+With+Concurrent+Administration+Of+Non-radiolabeled+Pf+06687234+As+Assessed+With+Positron+Emission+Tomography+And+Computed+Tomography+%28pet-ct%29+Imaging+In+Moderate+To+Severe+Ulcerative+Colitis+Subjects [https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7581003&StudyName=Phase+1b%2C+Open+Label+Study+To+Characterize+The+Distribution+Of+A+Single+Intravenous+Dose+Of+%5B124i%5D-iodobenzoyl+%28ib%29+Pf+06687234+With+Concurrent+Administration+Of+Non-radiolabeled+Pf+06687234+As+Assessed+With+Positron+Emission+Tomography+And+Computed+Tomography+%28pet-ct%29+Imaging+In+Moderate+To+Severe+Ulcerative+Colitis+Subjects] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To obtain contact information for a study center near you, click here.",null,"Yes","No",{"$nulls":19},"Percent injected radioactivity dose per kilogram (% ID/kg) in the colon (inflamed and non inflamed) and plasma|Standardized uptake value (SUV) in the colon (inflamed and non inflamed)","Treatment Arm","24 hours","AUC of PF 06687234 plasma concentrations over time|AUC of plasma radioactivity concentration (% ID/kg)|AUC in plasma, colon, liver, spleen, kidney and small intestine|Ratio of radioactivity AUC0-24H between colon, liver, spleen, kidney and small intestine to plasma|Frequency of clinically relevant abnormalities for Safety Labs|Cmax of PF 06687234 plasma concentrations over time|Tmax of PF 06687234 plasma concentrations over time|Cmax of plasma radioactivity concentration (% ID/kg)|Tmax of plasma radioactivity concentration (% ID/kg)|Cmax of radioactivity in plasma, colon, liver, spleen, kidney and small intestine|Tmax of radioactivity in plasma, colon, liver, spleen, kidney and small intestine|Frequency of clinically relevant abnormalities for vital signs|Frequency of clinically relevant abnormalities for ECG|Frequency of clinically relevant abnormalities for Immunogenicity","Treatment Arm","42 days|24 hours","ClinicalTrials.gov_Inquiries@pfizer.com","Pfizer CT.gov Call Center","1-800-718-1021","Guilford, Connecticut, United States, 06437 Endoscopy Center Of Connecticut, LlcHamden, Connecticut, United States, 06518 New Haven Clinical Research UnitNew Haven, Connecticut, United States, 06511 Yale University School Of MedicineNew Haven, Connecticut, United States, 06520","Connecticut","United States","Endoscopy Center Of Connecticut, Llc",{"$nulls":3},"Pfizer CT.gov Call Center","2018-09-17","2020-05-25T16:39:16.198","2020-05-26T17:10:42.972","NCT03414788"]
["5ecbf4b411702c1b1b916bac","NCT03414788","2019-07-08","Pfizer","PFE","Suspended","Distribution of a Single IV Dose Of [124I]-Pf 06687234 and Pf 06687234 Assessed With PET-CT Imaging In Moderate To Severe Ulcerative Colitis","Pf-06687234",null,"Yes","['Pf-06687234']","Unknown",null,"Phase 1",1,5,"Anticipated","2019-10-15","2020-12-09","SUV","Standardized Uptake Value",{"$nulls":3},"The purpose of the study is to evaluate the PK, safety and tolerability of PF-06687234 and [124I]IB-PF-06687234 (simultaneously given) in subjects with moderate to severe Ulcerative Colitis. The study used PET-CT scan imaging to assess the distribution of PF-06687234 and [124I]IB-PF-06687234 over 24 and 72 hours in colon (inflamed and non-inflamed), plasma, colon, liver, spleen, kidney and small intestine.",null,"PHASE 1B, OPEN LABEL STUDY TO CHARACTERIZE THE DISTRIBUTION OF A SINGLE INTRAVENOUS DOSE OF [124I]-IODOBENZOYL (IB) PF 06687234 WITH CONCURRENT ADMINISTRATION OF NON-RADIOLABELED PF 06687234 AS ASSESSED WITH POSITRON EMISSION TOMOGRAPHY AND COMPUTED TOMOGRAPHY (PET-CT) IMAGING IN MODERATE TO SEVERE ULCERATIVE COLITIS SUBJECTS","B7581003","Ulcerative Colitis","Colitis|Colitis, Ulcerative","Gastrointestinal Diseases","Gastrointestinal","Experimental","Treatment Arm - PF 06687234 and [124I]IB PF 06687234","PF 06687234 and [124I]IB PF 06687234","Biological","PF 06687234|[124I]IB PF 06687234","Subjects will be given single, intravenous dose of PF 06687234 and [124I]IB PF 06687234 simultaneously",null,"Treatment Arm - PF 06687234 and [124I]IB PF 06687234","\n\n * Male and/or female subjects of non-child bearing potential, 18 years to 75 years of age inclusive at the time of informed consent\n * Only women of non-child bearing potential\n * Diagnosis of active UC (histologic) prior to study entry for a minimum of 4 months\n * Subjects with moderate to severe, active UC as defined by Mayo stool frequency subscore of > 1, and/or rectal bleeding subscore of > 1\n * Mayo Endoscopic subscore of at least 2 for a portion of inflamed segment\n\n","\n\n * Clinically significant/unstable clinical conditions (eg. cancer hematological, endocrine etc)\n * Active enteric infections\n * Other forms of colitis such as Crohn's disease, infectious colitis etc",{"$nulls":4},"Actual","2018-01-30","Actual","Anticipated","2020-12-09","Anticipated","2019-07-01","2018-01-08","2018-01-26","2019-07-03","No","Positron Emission Tomography (PET), Ulcerative Colitis, Safety, PKPlasma","Interventional","Other","Single Group Assignment","None (Open Label)","N/A","18 Years","75 Years","All",null,"No","No\nPfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",null,"URL: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7581003&StudyName=Phase+1b%2C+Open+Label+Study+To+Characterize+The+Distribution+Of+A+Single+Intravenous+Dose+Of+%5B124i%5D-iodobenzoyl+%28ib%29+Pf+06687234+With+Concurrent+Administration+Of+Non-radiolabeled+Pf+06687234+As+Assessed+With+Positron+Emission+Tomography+And+Computed+Tomography+%28pet-ct%29+Imaging+In+Moderate+To+Severe+Ulcerative+Colitis+Subjects [https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7581003&StudyName=Phase+1b%2C+Open+Label+Study+To+Characterize+The+Distribution+Of+A+Single+Intravenous+Dose+Of+%5B124i%5D-iodobenzoyl+%28ib%29+Pf+06687234+With+Concurrent+Administration+Of+Non-radiolabeled+Pf+06687234+As+Assessed+With+Positron+Emission+Tomography+And+Computed+Tomography+%28pet-ct%29+Imaging+In+Moderate+To+Severe+Ulcerative+Colitis+Subjects] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To obtain contact information for a study center near you, click here.",null,"Yes","No",{"$nulls":19},"Percent injected radioactivity dose per kilogram (% ID/kg) in the colon (inflamed and non inflamed) and plasma|Standardized uptake value (SUV) in the colon (inflamed and non inflamed)","Treatment Arm","24 hours","AUC of PF 06687234 plasma concentrations over time|AUC of plasma radioactivity concentration (% ID/kg)|AUC in plasma, colon, liver, spleen, kidney and small intestine|Ratio of radioactivity AUC0-24H between colon, liver, spleen, kidney and small intestine to plasma|Frequency of clinically relevant abnormalities for Safety Labs|Cmax of PF 06687234 plasma concentrations over time|Tmax of PF 06687234 plasma concentrations over time|Cmax of plasma radioactivity concentration (% ID/kg)|Tmax of plasma radioactivity concentration (% ID/kg)|Cmax of radioactivity in plasma, colon, liver, spleen, kidney and small intestine|Tmax of radioactivity in plasma, colon, liver, spleen, kidney and small intestine|Frequency of clinically relevant abnormalities for vital signs|Frequency of clinically relevant abnormalities for ECG|Frequency of clinically relevant abnormalities for Immunogenicity","Treatment Arm","42 days|24 hours",{"$nulls":3},"Guilford, Connecticut, United States, 06437 Endoscopy Center Of Connecticut, LlcHamden, Connecticut, United States, 06518 New Haven Clinical Research UnitNew Haven, Connecticut, United States, 06511 Yale University School Of MedicineNew Haven, Connecticut, United States, 06520","Connecticut","United States","Endoscopy Center Of Connecticut, Llc",{"$nulls":3},"Pfizer CT.gov Call Center","2019-07-03","2020-05-25T16:39:16.447","2020-05-26T17:10:42.972","NCT03414788"]
["5ecbf4b4feab101b155309ce","NCT03414788","2019-12-11","Pfizer","PFE","Suspended","Distribution of a Single IV Dose Of [124I]-Pf 06687234 and Pf 06687234 Assessed With PET-CT Imaging In Moderate To Severe Ulcerative Colitis","Pf-06687234",null,"Yes","['Pf-06687234']","Unknown",null,"Phase 1",1,5,"Anticipated","2020-01-22","2021-03-18","SUV","Standardized Uptake Value",{"$nulls":3},"The purpose of the study is to evaluate the PK, safety and tolerability of PF-06687234 and [124I]IB-PF-06687234 (simultaneously given) in subjects with moderate to severe Ulcerative Colitis. The study used PET-CT scan imaging to assess the distribution of PF-06687234 and [124I]IB-PF-06687234 over 24 and 72 hours in colon (inflamed and non-inflamed), plasma, colon, liver, spleen, kidney and small intestine.",null,"PHASE 1B, OPEN LABEL STUDY TO CHARACTERIZE THE DISTRIBUTION OF A SINGLE INTRAVENOUS DOSE OF [124I]-IODOBENZOYL (IB) PF 06687234 WITH CONCURRENT ADMINISTRATION OF NON-RADIOLABELED PF 06687234 AS ASSESSED WITH POSITRON EMISSION TOMOGRAPHY AND COMPUTED TOMOGRAPHY (PET-CT) IMAGING IN MODERATE TO SEVERE ULCERATIVE COLITIS SUBJECTS","B7581003","Ulcerative Colitis","Colitis|Colitis, Ulcerative","Gastrointestinal Diseases","Gastrointestinal","Experimental","Treatment Arm - PF 06687234 and [124I]IB PF 06687234","PF 06687234 and [124I]IB PF 06687234","Biological","PF 06687234|[124I]IB PF 06687234","Subjects will be given single, intravenous dose of PF 06687234 and [124I]IB PF 06687234 simultaneously",null,"Treatment Arm - PF 06687234 and [124I]IB PF 06687234","\n\n * Male and/or female subjects of non-child bearing potential, 18 years to 75 years of age inclusive at the time of informed consent\n * Only women of non-child bearing potential\n * Diagnosis of active UC (histologic) prior to study entry for a minimum of 4 months\n * Subjects with moderate to severe, active UC as defined by Mayo stool frequency subscore of > 1, and/or rectal bleeding subscore of > 1\n * Mayo Endoscopic subscore of at least 2 for a portion of inflamed segment\n\n","\n\n * Clinically significant/unstable clinical conditions (eg. cancer hematological, endocrine etc)\n * Active enteric infections\n * Other forms of colitis such as Crohn's disease, infectious colitis etc",{"$nulls":4},"Actual","2018-01-30","Actual","Anticipated","2021-03-18","Anticipated","2019-12-01","2018-01-08","2018-01-26","2019-12-09","No","Positron Emission Tomography (PET), Ulcerative Colitis, Safety, PKPlasma","Interventional","Other","Single Group Assignment","None (Open Label)","N/A","18 Years","75 Years","All",null,"No","No\nPfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",null,"URL: https://pmiform.com/clinical-trial-info-request?StudyID=B7581003 [https://pmiform.com/clinical-trial-info-request?StudyID=B7581003] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To obtain contact information for a study center near you, click here.",null,"Yes","No",{"$nulls":19},"Percent injected radioactivity dose per kilogram (% ID/kg) in the colon (inflamed and non inflamed) and plasma|Standardized uptake value (SUV) in the colon (inflamed and non inflamed)","Treatment Arm","24 hours","AUC of PF 06687234 plasma concentrations over time|AUC of plasma radioactivity concentration (% ID/kg)|AUC in plasma, colon, liver, spleen, kidney and small intestine|Ratio of radioactivity AUC0-24H between colon, liver, spleen, kidney and small intestine to plasma|Frequency of clinically relevant abnormalities for Safety Labs|Cmax of PF 06687234 plasma concentrations over time|Tmax of PF 06687234 plasma concentrations over time|Cmax of plasma radioactivity concentration (% ID/kg)|Tmax of plasma radioactivity concentration (% ID/kg)|Cmax of radioactivity in plasma, colon, liver, spleen, kidney and small intestine|Tmax of radioactivity in plasma, colon, liver, spleen, kidney and small intestine|Frequency of clinically relevant abnormalities for vital signs|Frequency of clinically relevant abnormalities for ECG|Frequency of clinically relevant abnormalities for Immunogenicity","Treatment Arm","42 days|24 hours",{"$nulls":3},"Guilford, Connecticut, United States, 06437 Endoscopy Center Of Connecticut, LlcHamden, Connecticut, United States, 06518 New Haven Clinical Research UnitNew Haven, Connecticut, United States, 06511 Yale University School Of MedicineNew Haven, Connecticut, United States, 06520","Connecticut","United States","Endoscopy Center Of Connecticut, Llc",{"$nulls":3},"Pfizer CT.gov Call Center","2019-12-09","2020-05-25T16:39:16.568","2020-05-26T17:10:42.972","NCT03414788"]
["5ecbf4b7307e3d1b1f8d9e38","NCT03415243","2018-03-20","GlaxoSmithKline","GSK","Recruiting","To Investigate the Gastrointestinal Behaviour of Two Triple Combination Products in Healthy Male Volunteers","Acetaminophen|Dextromethorphan|Phenylephrine","COX2 Inhibitor|CYP2D6 Inhibitor|S1R Agonist|NMDA Antagonist|ADRA1A Agonist","No",null,"No",null,"Phase 1",2,24,"Anticipated","2018-03-01","2018-03-29","AUC","Area Under The Curve",{"$nulls":3},"This clinical study will be conducted to characterize the gastrointestinal transit of two multi-symptoms formulations by inclusion of a radiolabel marker.","This study will be an open label, randomized, single dose, parallel groups gamma scintigraphic study. A total of 28 healthy male participants will be randomized (14 participantper treatment arm) in order to have 24 evaluable participants (12 participants per treatment arm). Participants will be randomized to receive either a single dose Treatment A (Theraflu daytime Severe Cold & Cough powder) or single dose of Treatment B (Theraflu ExpressMax Daytime Severe Cold and Cough caplets). This study will consist of screening visit (Visit 1), followed by a treatment visit (Visit 2). Visit 2 includes two days: Day -1 and Day 1. On visit 2 (day -1) of the study, the study participants will be admitted to the unit at approximately 7 pm on the evening before study drug administration and will receive a standardized meal. Participants will be required to fast (nothing to eat or drink except non-carbonated water) from 10 hours prior until 4 hours after study drug administration. Water will be permitted until 1 hour prior to investigational product administration, and no additional fluids until the lunch meal will be served at approximately 4 hours post dose. Participants will then be given a standard lunch at 4 hours post-dose, a standard dinner at 10 hours post-dose on Day 1. Participants will be discharged from the unit after the last scintigraphic imaging is performed, blood sample for laboratory test will be taken as well as a brief physical examination. Scintigraphic acquisitions will be taken beginning after dose administration until 10 hours post-dose.","A Single Dose, Open Label, Randomized Scintigraphic Study to Investigate the Gastrointestinal Behavior of 2 Triple Combination Products (Acetaminophen, Phenylephrine and Dextromethorphan) in Healthy Male Volunteers",208821,"Common Cold","Common Cold","RNA Virus Infections","Virology","Experimental","Treatment A Group|Treatment B Group","Participants will receive a single dose (1 sachet) of the investigational product (Acetaminophen 650mg+Dextromethorphan 20mg+Phenylephrine 10mg).|Participants will receive a single dose (2 caplets) of the investigational product (Acetaminophen 325mg+Dextromethorphan 10mg+Phenylephrine 5mg).","Drug","Acetaminophen 650mg+Dextromethorphan 20mg+Phenylephrine 10mg|Acetaminophen 325mg+Dextromethorphan 10mg+Phenylephrine 5mg","Contents of the sachet will be emptied into a glass bottle and 225 mL of hot, but not boiling water (approximately 90-95Â°C), will be added to the container and mixed to dissolve the contents of the sachet. The dissolved solution will be allowed to cool to approximately 40 - 50 degree Celsius (Â°C). After cooling, a small volume (1 to 10 microliters, [ÂµL]) of 99mTc-DTPA (Technetium-99m-diethylene-triamine-pentaacetate will be added to the drug solution in to achieve a maximum of 108 curie(ÂµCi) i.e.4 megabecquerel [MBq] per individual dose at the time of dosing. The container will be capped and maintained at a temperature between 35-45Â°C at time of dosing and then participants will be instructed to consume the hot drink entirely within 30 seconds.|Caplet doses will be prepared by drilling a hole of approximately 1 millimetre (mm) diameter and at a depth of approximately one-half of its thickness (~2-2.5 mm deep) into individual caplets. 99mTc-DTPA (dissolved in normal saline) will be added into the hole of each caplet as a low volume liquid (0.5-2.0 ÂµL) to achieve a maximum of 54 ÂµCi (2 MBq) per individual caplet at the time of dosing (two caplets = 108 ÂµCi (4 MBq) dose per assessment visit). The applied liquid will be allowed to air dry and the hole will be filled with the equivalent powder blend from a crushed caplet such that the drug content will remain constant and same for all caplets. The caplet will be sealed with an appropriate material if determined to be necessary. Radiolabeled caplets will be packaged as unit doses (2 caplets per container) and maintained at room temperature until administration. Caplets will be swallowed with 225 mL of non-carbonated room temperature water within 30 seconds.",null,"Treatment A Group|Treatment B Group","\n\n * Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study before any assessment is performed.\n * Healthy male participants who, at the time of screening, are between the ages of 21 and 45 years, inclusive.\n * Participants who are willing and able to comply with scheduled visits, treatment plan, bio-imaging procedure, laboratory tests and other study procedures.\n * Healthy participant which is defined as in general good physical health, as judged by the investigator and no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead Electrocardiogram (ECG) or clinical laboratory tests.\n * Body Mass Index (BMI) of 17.5 to 30.5 kilogram per meter square (kg/m2); and a total body weight >50 kg (110 lbs)\n\n","\n\n * Participants who are investigational site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or participants who are GSK employees directly involved in the conduct of the study.\n * Participation in other studies involving investigational drug(s) within 30 days prior to study entry and/or during study participation.\n * Acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.\n * Known or suspected intolerance or hypersensitivity or contraindication to the study materials (or closely related compounds) or any of their stated ingredients.\n * Participant with known allergy or intolerance to any of the contents of the standard meals.\n * Participant is vegetarian.\n * Unwilling or unable to comply with the Lifestyle guidelines described in this protocol.\n * Use of prescription or non-prescription drugs and dietary supplements within 14 days or 5 half-lives, whichever is longer, prior to the first dose of investigational product that are deemed by the investigator to have a potential impact on the study objectives results.\n * Evidence or history of clinically significant laboratory abnormality, hematological, renal, endocrine, pulmonary, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease within the last 5 years that may increase the risk associated with study participation.\n * A positive urine drug screen, breath alcohol test or urine cotinine test during Screening or on Day -1 of the study.\n * Any condition possibly affecting drug absorption (e.g., gastrectomy)\n * A history of current or relevant previous non-self-limiting gastrointestinal disorders peptic ulcer disease and/or gastrointestinal bleeding.\n * Currently suffering from disease known to impact gastric emptying, e.g. migraine, insulin-dependent diabetes mellitus.\n * The participant has had radiation exposure from clinical trials, including from the present study, and from therapeutic or diagnostic exposure, but excluding background radiation, exceeding a target organ (colon) dose of 50 mSv (5 rems) from a single dose within the last 30 days or a cumulative dose of 150 mSv (15 rems) in the last 12 months. No participant whose occupation requires monitoring for radiation exposure will be enrolled in the study.\n * Participants who have been exposed to ionising radiation in excess of 10 mSv (whole body effective dose) above background over the previous 3 years period as a result of occupational exposure or previous participation in research studies. Clinically justified (therapeutic or diagnostic) exposures are not included in this calculation.\n * Renal disease or impaired renal function at screening as indicated by abnormal levels of serum creatinine or urea or the presence of clinically significant abnormal urinary constituents (e.g. albuminuria). Minor deviations of laboratory values from the normal range are permitted, if judged by the investigator to have no clinical relevance.\n * History or current evidence of ongoing hepatic disease or impaired hepatic function at screening. A candidate will be excluded if more than one of the following lab value deviations are found: 1) AST/SGOT (â‰¥ 1.2 ULN), ALT/SGPT (â‰¥ 1.2 ULN), 2) GGT (â‰¥ 1.2 ULN), ALP (â‰¥ 1.2 ULN), 3) total bilirubin (â‰¥ 1.2 mg/dL) Minor deviations of laboratory values from the normal range are permitted, if judged by the investigator to have no clinical relevance. Positive results in any of the virology tests for HIV-Ab, HCV-Ab, HBsAg and HBc-Ab (Total).\n * Diagnosis of long QT syndrome or QTc > 450 msec for males at screening.\n * Participants who were intending to father a child in the 3 months following the study.\n * Participants who were unwilling to follow contraception requirements\n * Participant had any non-removable metal objects such as metal plates, screws etc. in their chest or abdominal area.\n * History of regular alcohol consumption exceeding 14 drinks/week (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of Screening.\n * Smokers defined as the use of tobacco products (including but not limited to: electronic-cigarettes, nicotine gums, nicotine lozenges, etc) during the 6 months prior to screening or a positive urine cotinine test at screening.\n * Participant has consumed (eat or drink) grapefruit or grapefruit-related citrus fruits (e.g., Seville oranges, pomelos, pawpaw, dragon fruit, kiwi fruit, mango, passion fruit, pomegranate, rambutan, star fruit or products that contain these fruits) 14 days prior to the first dose of investigational product.\n * Participants who have previously been enrolled in this study.",{"$nulls":4},"Actual","2018-01-30","Actual","Anticipated","2018-03-29","Anticipated","2018-03-01","2018-01-23","2018-01-23","2018-03-19",null,null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","21 Years","45 Years","Male",null,"Yes",{"$nulls":4},"Yes","No",{"$nulls":4},"No",{"$nulls":14},"Mean time to onset of gastric emptying|Mean time to complete gastric emptying|Characterize gastrointestinal emptying by measuring GE25% values|Characterize gastrointestinal emptying by measuring GE50% values|Characterize gastrointestinal emptying by measuring GE90% values|Amount of drug remaining in the stomach after administration at different timepoints|Sectional areas under the gastric emptying curve and Total AUC|Total Area under the curve (AUC)|Gastric emptying t half (t-1/2) value|Small intestinal transit time","Scintigraphic imaging will be performed immediately following ingestion of the radiolabeled drug formulation and data will be recorded and stored. Images will be analyzed in a time-lapse format. Regions of interest (ROI) will be drawn to include the stomach, proximal small intestine, distal small intestine and colon. Each image will be corrected for radioactive decay and background radiation. Mean time to onset of gastric emptying will be evaluated.|Scintigraphic imaging will be performed immediately following ingestion of the radiolabeled drug formulation and data will be recorded and stored. Images will be analyzed in a time-lapse format. ROI will be drawn to include the stomach, proximal small intestine, distal small intestine and colon. Each image will be corrected for radioactive decay and background radiation. Mean time to complete gastric emptying will be evaluated.|Scintigraphic imaging will be performed immediately following ingestion of the radiolabeled drug formulation and data will be recorded and stored. Images will be analyzed in a time-lapse format. ROI will be drawn to include the stomach, proximal small intestine, distal small intestine and colon Each image will be corrected for radioactive decay and background radiation. Time for tracer to leave the stomach i.e. GE25% values will be evaluated.|Scintigraphic imaging will be performed immediately following ingestion of the radiolabeled drug formulation and data will be recorded and store. Images will be analyzed in a time-lapse format. ROI will be drawn to include the stomach, proximal small intestine, distal small intestine and colon. Each image will be corrected for radioactive decay and background radiation. Time for tracer to leave the stomach i.e. GE50% will be evaluated.|Scintigraphic imaging will be performed immediately following ingestion of the radiolabeled drug formulation and data will be recorded and stored. Images will be analyzed in a time-lapse format. ROI will be drawn to include the stomach, proximal small intestine, distal small intestine and colon. Each image will be corrected for radioactive decay and background radiation. Time for tracer to leave the stomach i.e. GE90% values will be evaluated.|Scintigraphic imaging will be performed immediately following ingestion of the radiolabeled drug formulation and data will be recorded and stored. Images will be analyzed in a time-lapse format. ROI will be drawn to include the stomach, proximal small intestine, distal small intestine and colon. Each image will be corrected for radioactive decay and background radiation. Amount of drug (labelled with tracer) remaining in the stomach after administration at different timepoints i.e. at 15, 30, 45, 60, 75, 90, 105, 120, 180, 240 mins will be determined.|Scintigraphic imaging will be performed immediately following ingestion of the radiolabeled drug formulation and data will be recorded and stored. Images will be analyzed in a time-lapse format. ROI will be drawn to include the stomach, proximal small intestine, distal small intestine and colon. Each image will be corrected for radioactive decay and background radiation. Sectional areas under the gastric emptying curve will be calculated using the data.|Scintigraphic imaging will be performed immediately following ingestion of the radiolabeled drug formulation and data will be recorded and stored. Images will be analyzed in a time-lapse format. ROI will be drawn to include the stomach, proximal small intestine, distal small intestine and colon. Each image will be corrected for radioactive decay and background radiation. Total Area under the curve will be calculated using the data.|Scintigraphic imaging will be performed immediately following ingestion of the radiolabeled drug formulation and data will be recorded and stored. Scintigraphic images will be analyzed in a time-lapse format. ROI will be drawn to include the stomach, proximal small intestine, distal small intestine and colon Each image will be corrected for radioactive decay and background radiation. T-1/2 value will be calculated.|Scintigraphic imaging will be performed immediately following ingestion of the radiolabeled drug formulation and data will be recorded and stored electronically. Images will be analyzed in a time-lapse format. ROI will be drawn to include the stomach, proximal small intestine, distal small intestine and colon. Each image will be corrected for radioactive decay and background radiation. Small intestinal transit time will be calculated by determining the arrival time of the radioactive marker at the cecum / colon region and subtracting the gastric emptying value.","up to 10 hours post drug administration of Day 1","Safety (Adverse events Monitoring)|Safety (Laboratory Evaluations)","Adverse events (AEs) will be monitored and recorded.|Blood and urine Human Biological Samples (HBS) will be collected for safety laboratory tests.","From Baseline, to 5 days following last administration of investigational product|At Baseline and Day 1","GSKClinicalSupportHD@gsk.com","US GSK Clinical Trials Call Center","877-379-3718","Lexington, Kentucky, United States, 40504","Kentucky","United States","Gsk Investigational Site",{"$nulls":3},"GSK Clinical Trials","2018-03-19","2020-05-25T16:39:19.947","2020-05-26T17:10:42.972","NCT03415243"]
["5ecbf4b711702c1b1b916bb3","NCT03415243","2019-06-24","GlaxoSmithKline","GSK","Completed","To Investigate the Gastrointestinal Behaviour of Two Triple Combination Products in Healthy Male Volunteers","Acetaminophen|Dextromethorphan|Phenylephrine","COX2 Inhibitor|CYP2D6 Inhibitor|S1R Agonist|NMDA Antagonist|ADRA1A Agonist","No",null,"No",null,"Phase 1",2,28,"Actual","2018-03-01","2018-03-29",{"$nulls":5},"This clinical study will be conducted to characterize the gastrointestinal transit of two multi-symptoms formulations by inclusion of a radiolabel marker.","This study will be an open label, randomized, single dose, parallel groups gamma scintigraphic study. A total of 28 healthy male participants will be randomized (14 participantper treatment arm) in order to have 24 evaluable participants (12 participants per treatment arm). Participants will be randomized to receive either a single dose Treatment A (Theraflu daytime Severe Cold & Cough powder) or single dose of Treatment B (Theraflu ExpressMax Daytime Severe Cold and Cough caplets). This study will consist of screening visit (Visit 1), followed by a treatment visit (Visit 2). Visit 2 includes two days: Day -1 and Day 1. On visit 2 (day -1) of the study, the study participants will be admitted to the unit at approximately 7 pm on the evening before study drug administration and will receive a standardized meal. Participants will be required to fast (nothing to eat or drink except non-carbonated water) from 10 hours prior until 4 hours after study drug administration. Water will be permitted until 1 hour prior to investigational product administration, and no additional fluids until the lunch meal will be served at approximately 4 hours post dose. Participants will then be given a standard lunch at 4 hours post-dose, a standard dinner at 10 hours post-dose on Day 1. Participants will be discharged from the unit after the last scintigraphic imaging is performed, blood sample for laboratory test will be taken as well as a brief physical examination. Scintigraphic acquisitions will be taken beginning after dose administration until 10 hours post-dose.","A Single Dose, Open Label, Randomized Scintigraphic Study to Investigate the Gastrointestinal Behavior of 2 Triple Combination Products (Acetaminophen, Phenylephrine and Dextromethorphan) in Healthy Male Volunteers",208821,"Common Cold","Common Cold","RNA Virus Infections","Virology","Experimental","Treatment A Group|Treatment B Group","Participants will receive a single dose (1 sachet) of the investigational product (Acetaminophen 650mg+Dextromethorphan 20mg+Phenylephrine 10mg).|Participants will receive a single dose (2 caplets) of the investigational product (Acetaminophen 325mg+Dextromethorphan 10mg+Phenylephrine 5mg).","Drug","Acetaminophen 650mg+Dextromethorphan 20mg+Phenylephrine 10mg|Acetaminophen 325mg+Dextromethorphan 10mg+Phenylephrine 5mg","Contents of the sachet will be emptied into a glass bottle and 225 mL of hot, but not boiling water (approximately 90-95Â°C), will be added to the container and mixed to dissolve the contents of the sachet. The dissolved solution will be allowed to cool to approximately 40 - 50 degree Celsius (Â°C). After cooling, a small volume (1 to 10 microliters [mcL]) of 99mTc-DTPA (Technetium-99m-diethylene-triamine-pentaacetate will be added to the drug solution in to achieve a maximum of 108 curie(mcCi) i.e.4 megabecquerel [MBq] per individual dose at the time of dosing. The container will be capped and maintained at a temperature between 35-45Â°C at time of dosing and then participants will be instructed to consume the hot drink entirely within 30 seconds.|Caplet doses will be prepared by drilling hole of approximately(app.)1millimetre(mm)diameter and app.2-2.5mm deep into individual caplets.99mTc-DTPA(dissolved in normal saline)will be added into hole of each caplet as low volume liquid(0.5-2.0mcL)to achieve maximum of 54 mcCi(2MBq)per caplet at time of dosing(2caplets=108 mcCi[4MBq]dose per assessment visit).Applied liquid will be allowed to air dry,hole to be filled with equivalent powder blend from crushed caplet so drug content will remain constant for all caplets.Caplet will be sealed with appropriate material.Radiolabeled caplets will be packaged as unit doses(2 caplets per container)and maintained at room temperature until administration.Caplets will be swallowed with 225mL of noncarbonated room temperature water within 30 seconds.","Theraflu daytime severe cold and cough powder|Theraflu expressmax daytime severe cold and cough caplets","Treatment A Group|Treatment B Group","\n\n * Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study before any assessment is performed.\n * Healthy male participants who, at the time of screening, are between the ages of 21 and 45 years, inclusive.\n * Participants who are willing and able to comply with scheduled visits, treatment plan, bio-imaging procedure, laboratory tests and other study procedures.\n * Healthy participant which is defined as in general good physical health, as judged by the investigator and no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead Electrocardiogram (ECG) or clinical laboratory tests.\n * Body Mass Index (BMI) of 17.5 to 30.5 kilogram per meter square (kg/m2); and a total body weight >50 kg (110 lbs)\n\n","\n\n * Participants who are investigational site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or participants who are GSK employees directly involved in the conduct of the study.\n * Participation in other studies involving investigational drug(s) within 30 days prior to study entry and/or during study participation.\n * Acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.\n * Known or suspected intolerance or hypersensitivity or contraindication to the study materials (or closely related compounds) or any of their stated ingredients.\n * Participant with known allergy or intolerance to any of the contents of the standard meals.\n * Participant is vegetarian.\n * Unwilling or unable to comply with the Lifestyle guidelines described in this protocol.\n * Use of prescription or non-prescription drugs and dietary supplements within 14 days or 5 half-lives, whichever is longer, prior to the first dose of investigational product that are deemed by the investigator to have a potential impact on the study objectives results.\n * Evidence or history of clinically significant laboratory abnormality, hematological, renal, endocrine, pulmonary, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease within the last 5 years that may increase the risk associated with study participation.\n * A positive urine drug screen, breath alcohol test or urine cotinine test during Screening or on Day -1 of the study.\n * Any condition possibly affecting drug absorption (e.g., gastrectomy)\n * A history of current or relevant previous non-self-limiting gastrointestinal disorders peptic ulcer disease and/or gastrointestinal bleeding.\n * Currently suffering from disease known to impact gastric emptying, e.g. migraine, insulin-dependent diabetes mellitus.\n * The participant has had radiation exposure from clinical trials, including from the present study, and from therapeutic or diagnostic exposure, but excluding background radiation, exceeding a target organ (colon) dose of 50 mSv (5 rems) from a single dose within the last 30 days or a cumulative dose of 150 mSv (15 rems) in the last 12 months. No participant whose occupation requires monitoring for radiation exposure will be enrolled in the study.\n * Participants who have been exposed to ionising radiation in excess of 10 mSv (whole body effective dose) above background over the previous 3 years period as a result of occupational exposure or previous participation in research studies. Clinically justified (therapeutic or diagnostic) exposures are not included in this calculation.\n * Renal disease or impaired renal function at screening as indicated by abnormal levels of serum creatinine or urea or the presence of clinically significant abnormal urinary constituents (e.g. albuminuria). Minor deviations of laboratory values from the normal range are permitted, if judged by the investigator to have no clinical relevance.\n * History or current evidence of ongoing hepatic disease or impaired hepatic function at screening. A candidate will be excluded if more than one of the following lab value deviations are found: 1) AST/SGOT (â‰¥ 1.2 ULN), ALT/SGPT (â‰¥ 1.2 ULN), 2) GGT (â‰¥ 1.2 ULN), ALP (â‰¥ 1.2 ULN), 3) total bilirubin (â‰¥ 1.2 mg/dL) Minor deviations of laboratory values from the normal range are permitted, if judged by the investigator to have no clinical relevance. Positive results in any of the virology tests for HIV-Ab, HCV-Ab, HBsAg and HBc-Ab (Total).\n * Diagnosis of long QT syndrome or QTc > 450 msec for males at screening.\n * Participants who were intending to father a child in the 3 months following the study.\n * Participants who were unwilling to follow contraception requirements\n * Participant had any non-removable metal objects such as metal plates, screws etc. in their chest or abdominal area.\n * History of regular alcohol consumption exceeding 14 drinks/week (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of Screening.\n * Smokers defined as the use of tobacco products (including but not limited to: electronic-cigarettes, nicotine gums, nicotine lozenges, etc) during the 6 months prior to screening or a positive urine cotinine test at screening.\n * Participant has consumed (eat or drink) grapefruit or grapefruit-related citrus fruits (e.g., Seville oranges, pomelos, pawpaw, dragon fruit, kiwi fruit, mango, passion fruit, pomegranate, rambutan, star fruit or products that contain these fruits) 14 days prior to the first dose of investigational product.\n * Participants who have previously been enrolled in this study.",{"$nulls":4},"Actual","2018-01-30","Actual","Actual","2018-03-29","Actual","2019-03-01","2018-01-23","2018-01-23","2019-03-27",null,null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","21 Years","45 Years","Male",null,"Yes",{"$nulls":4},"Yes","No","2019-03-27","2019-03-27","2019-06-24","Actual",{"$nulls":24},"Lexington, Kentucky, United States, 40504","Kentucky","United States","Gsk Investigational Site",{"$nulls":3},"GSK Clinical Trials","2019-03-27","2020-05-25T16:39:19.890","2020-05-26T17:10:42.972","NCT03415243"]
["5ecbf4bee2561b1b11905ea7","NCT03416179","2018-02-12","Pfizer","PFE","Not yet recruiting","A Study Evaluating Intensive Chemotherapy With or Without Glasdegib or Azacitidine With or Without Glasdegib In Patients With Previously Untreated Acute Myeloid Leukemia (BRIGHT AML1019)","Glasdegib|Cytarabine|Daunorubicin|Azacitidine","Hh Inhibitor|DNA Polymerase Inhibitor|Nucleic Acid Synthesis Inhibitor|TOP2 Inhibitor|DNA Mtase Inhibitor","Yes","['Glasdegib']","Unknown",null,"Phase 3",4,720,"Anticipated","2018-02-28","2023-01-16","OS","Overall Survival",{"$nulls":3},"Glasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).\n\nGlasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).","Two separate registration trials conducted under one protocol number are proposed to adequately and independently evaluate the addition of glasdegib in intensive and non-intensive chemotherapy populations. Each study will have an experimental treatment arm and a placebo arm. Endpoints are the same for each study except where specifically indicated.\n\nAssignment to the Intensive Study or the Non-Intensive Study will be made by the Investigator based on the 2017 European LeukemiaNet (ELN) recommendations.\n\nStudy B1371019 is a randomized (1:1), double-blind, multi-center, placebo controlled study of chemotherapy in combination with glasdegib versus chemotherapy in combination with placebo in adult patients with previously untreated AML.\n\nGlasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).\n\nGlasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).","A RANDOMIZED (1:1), DOUBLE-BLIND, MULTI-CENTER, PLACEBO CONTROLLED STUDY EVALUATING INTENSIVE CHEMOTHERAPY WITH OR WITHOUT GLASDEGIB (PF-04449913) OR AZACITIDINE (AZA) WITH OR WITHOUT GLASDEGIB IN PATIENTS WITH PREVIOUSLY UNTREATED ACUTE MYELOID LEUKEMIA","B1371019","Leukemia, Myeloid, Acute","Acute Leukemia|Acute Myeloid Leukemia|Myeloid Leukemia|Leukemia","Oncology Hematological","Oncology","Experimental|Placebo Comparator","Arm A (Intensive Study)|Arm B (Intensive Study)|Arm A (Non-intensive study)|Arm B (Non-intensive study)","Glasdegib + '7+3' Induction(s)|Placebo + '7+3' Induction(s)|Glasdegib + azacitidine|Placebo + azacitidine","Drug|Procedure","glasdegib|daunorubicin + cytarabine|cytarabine|HSCT|Placebo|azacitidine","Daily Glasdegib (100 mg, PO), beginning on Day 1 and is to continue up to 2 years post randomization.\n\nFollowing consolidation therapy, glasdegib or placebo will be administered daily for up to 2 years after randomization or until they have minimal residual disease (MRD) negative disease, whichever comes first.\n\nDaily Glasdegib (100 mg, PO) or matching placebo will continue throughout Induction(s) and Consolidation therapies regardless of dose modifications/delays in the chemotherapy.|Consolidation with single agent cytarabine 3 g/m2 IV for adults <60 years and 1 g/m2 for adults 60 years over 3 BID on Days 1, 3, and 5, every 28 days for up to 4 cycles or alternative single agent cytarabine consolidation schedules may be used per local prescribing information.|If required, and done per standard of care post Induction(s).|Azacitidine (75 mg/m2, SC or IV) daily for 7 days, in 28 day cycles for as long as they do not meet the criteria for disease progression, unacceptable toxicity, consent withdrawal, or death.|Matching placebo (PO) is to be administered by mouth daily beginning on Day 1 of chemotherapy and will continue if subjects demonstrate reasonable evidence of clinical benefit and do not meet the criteria for progression regardless of any delays/modifications in the chemotherapy treatment. Subjects will continue placebo until disease progression, unacceptable toxicity, consent withdrawal, or death, whichever comes first.","PF-04449913","Arm A (Intensive Study)|Arm B (Intensive Study)|Arm A (Non-intensive study)|Arm B (Non-intensive study)","\n\nSubjects must meet all of the following inclusion criteria to be eligible for enrollment into the Intensive and Non Intensive study (unless where indicated):\n\n 1.  Subjects with untreated AML according to the World Health Organization (WHO) 2016 Classification2, including those with: * AML arising from MDS or another antecedent hematologic disease (AHD).\n      * AML after previous cytotoxic therapy or radiation (secondary AML).\n     \n     \n 2.  18 years of age (In Japan, 20 years of age).\n 3.  Adequate Organ Function as defined by the following: * Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) 3 x upper limit of normal (ULN), excluding subjects with liver function abnormalities due to underlying malignancy.\n      * Total serum bilirubin 2 x ULN (except subjects with documented Gilbert's syndrome).\n      * Estimated creatinine clearance 30 mL/min as calculated using the standard method for the institution.\n     \n     \n 4.  QTc interval 470 msec using the Fridericia correction (QTcF).\n 5.  All anti cancer treatments (unless specified) should be discontinued 2 weeks from study entry, for example: targeted chemotherapy, radiotherapy, investigational agents, hormones, anagrelide or cytokines. * For control of rapidly progressing leukemia, all trans retinoic acid (ATRA), hydroxyurea, and/or leukopheresis may be used before and for up to 1 week after the first dose of glasdegib.\n     \n     \n 6.  Serum or urine pregnancy test (for female subjects of childbearing potential) with a minimum sensitivity of 25 IU/L or equivalent units of human chorionic gonadotropin (hCG) negative at screening.\n 7.  Male and female subjects of childbearing potential and at risk for pregnancy must agree to use at least one highly effective method of contraception throughout the study and for 180 days after the last dose of azacitidine, cytarabine, or daunorubicin; and the last dose of glasdegib or placebo, whichever occurs later.\n 8.  Female subjects of non childbearing potential must meet at least 1 of the following criteria: 1. Have undergone a documented hysterectomy and/or bilateral oophorectomy;\n      2. Have medically confirmed ovarian failure; or\n      3. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; status may be confirmed by having a serum follicle stimulating hormone (FSH) level confirming the postmenopausal state.\n     \n     All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential.\n     \n     \n 9.  Consent to a saliva sample collection for a germline comparator, unless prohibited by local regulations or ethics committee (EC) decision.\n 10. Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.\n 11. Subjects who are willing and able to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures (including bone marrow [BM] assessments).\n\n","\n\nSubjects with any of the following characteristics/conditions will not be included in the study:\n\n 1.  Acute Promyelocytic Leukemia (APL) and APLwith PML RARA, subjects (WHO 2016 classification).\n 2.  AML with BCR ABL1 or t(9;22)(q34;q11.2) as a sole abnormality. * Complex genetics may include t(9;22) cytogenetic translocation.\n     \n     \n 3.  Subjects with known active CNS leukemia.\n 4.  Participation in other clinical studies involving other investigational drug(s) (Phases 1 4) within 4 weeks prior study entry and/or during study participation.\n 5.  Subjects known to be refractory to platelet or packed red cell transfusions per Institutional Guidelines, or a patient who refuses blood product support.\n 6.  Subjects with another active malignancy on treatment with the exception of basal cell carcinoma, non melanoma skin cancer, cervical carcinoma in situ. Other prior or concurrent malignancies will be considered on a case by case basis.\n 7.  Any one of the following ongoing or in the previous 6 months: myocardial infarction, congenital long QT syndrome, Torsades de pointes, symptomatic arrhythmias (including sustained ventricular tachyarrhythmia), right or left bundle branch block and bifascicular block, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (CHF New York Heart Association class III or IV), cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism; as well as bradycardia defined as <50 bpms.\n 8.  Subjects with an active, life threatening or clinically significant uncontrolled systemic infection not related to AML.\n 9.  Subjects with left ventricular ejection fraction (LVEF) <50% are excluded from the Intensive Chemotherapy Study only.\n 10. Cumulative anthracycline dose equivalent of 550 mg/m2 of daunorubicin for the Intensive Chemotherapy Study only.\n 11. Known malabsorption syndrome or other condition that may significantly impair absorption of study medication in the investigator's judgment (eg, gastrectomy, lap band, Crohn's disease) and inability or unwillingness to swallow tablets or capsules.\n 12. Current use or anticipated requirement for drugs that are known strong CYP3A4/5 inducers.\n 13. Concurrent administration of herbal preparations.\n 14. Major surgery or radiation within 4 weeks of starting study treatment.\n 15. Documented or suspected hypersensitivity to any one of the following: * For subjects assigned to intensive chemotherapy, documented or suspected hypersensitivity to cytarabine (not including drug fever or exanthema, including known cerebellar side effects) or daunorubicin.\n      * For subjects assigned to non intensive chemotherapy, documented or suspected hypersensitivity to azacitidine or mannitol.\n     \n     \n 16. Known active drug or alcohol abuse.\n 17. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.\n 18. Pregnant females or breastfeeding female subjects.\n 19. Known recent or active suicidal ideation or behavior.\n 20. Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.","FSH",null,"Protein","Ovary","Actual","2018-01-31","Actual","Anticipated","2025-02-27","Anticipated","2018-02-01","2017-12-21","2018-01-23","2018-02-08","Yes","glasdegib;\nuntreated;\nHedgehog Inhibitor","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"All",null,"No","Yes\nInformation relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests",null,"URL: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1371019&StudyName=A+Randomized+%281%3A1%29%2C+Double+Blind%2C+Multi+Center%2C+Placebo+Controlled+Study+Evaluating+Intensive+Chemotherapy+With+Or+Without+Glasdegib+%28pf+04449913%29+Or+Azacitidine+%28aza%29+With+Or+Without+Glasdegib+In+Patients+With+Previously+Untreated+Acute+Myeloid+Leukemia [https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1371019&StudyName=A+Randomized+%281%3A1%29%2C+Double+Blind%2C+Multi+Center%2C+Placebo+Controlled+Study+Evaluating+Intensive+Chemotherapy+With+Or+Without+Glasdegib+%28pf+04449913%29+Or+Azacitidine+%28aza%29+With+Or+Without+Glasdegib+In+Patients+With+Previously+Untreated+Acute+Myeloid+Leukemia] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To obtain contact information for a study center near you, click here.",null,"Yes","No",{"$nulls":17},"2017-002822-19|BRIGHT|BRIGHT AML1019","EudraCT Number|Alias Study Number","Overall survival","5 years after last subject randomized",null,"Fatigue score measured by the MD Anderson Symptom Inventory (MDASI)-AML/MDS questionnaire|Rate of Complete Remission (CR) (including CR with minimal residual disease (MRD)-negative as assessed by multiparametric flow cytometry)|Duration of response (defined as CR [includes CR-MRD negative]/CRi or CR/CRh as appropriate)|Time to response (CR[includes CR-MRD negative)]/CR with partial hematologic rcovery (CRh) as appropriate)|Event-free Survival|Patient Reported Outcomes (PROs) as measured by the M.D. Anderson Symptom Inventory AML/MDS Module (MDASI-AML/MDS)|Adverse events as graded by NCI CTCAE v4.03|Laboratory abnormalities as graded by NCI CTCAE v4.03|For the intensive study, the plasma trough concentration (Ctrough) will be analyzed|QTc interval|PROs as measured by Patient Global Impression of Change (PGIC)|Patient Reported Outcomes (PROs) as measured by EuroQoL 5 Dimension questionnaire 5-Level version (EQ-5D-5L)|Patient Reported Outcomes (PROs) as measured by Patient Global Impression of Symptoms (PGIS)|Complete Remission with incomplete hematologic recovery (CRi)|Rate of morphological leukemia-free state (MLFS)|Rate of Partial Remission (PR)|Rate of Complete Remission with partial hematological recovery (CRh) for the Non-intensive study only only|Minimum Observed Plasma Trough Concentratrion of glasdegib in the Intensive Study|Minimum Observed Plasma Trough Concentration of glasdegib in the Non-intensive study","Scale is from 0-10 where 0 is not present and 10 is as bad as you can image.|Response as defined by the 2017 European LeukemiaNet (ELN) recommendations.|5 years after last subject randomized, consent withdrawal, or death|Measurement Scale from 0-10.|PK samples taken on Induction(s) Day 1 (1 and 4 hours post induction); Induction(s) Day 10 (pre-dose, 1 and 4 hours post dose); Day 1 of each Consolidation cycle (pre-dose, 1 and 4 hours post dose)|One question asking for description of leukemia symptoms.|Series of questions that ask for information that best describes health.|One question asking for information regarding leukemia symptoms.|Its the minimum trough concentration in plasma of glasdegib following multiple daily dosing to steady state.|It is the minimum trough concentration in plasma of glasdegib following multiple daily dosing to steady state.","5 years after last subject randomized, consent withdrawal, or death|2 years after last dose of study therapy|5 years after last patient randomized, withdrawal, or death|5 years after last subject randomized, withdrawal, or death|Day 10 of Induction Cycle and Day 1 of each Consolidation Cycle|Cycle 1 Day 15 and Cycles 2 and 3 on Day 1","ClinicalTrials.gov_Inquiries@pfizer.com","Pfizer CT.gov Call Center","1-800-718-1021","Osaka-City, Osaka, Japan, 545-8586|Tachikawa, Tokyo, Japan, 190-0014",null,"Japan","Osaka Osaka City University Hospital|Tokyo National Hospital Organization Disaster Medical Center",{"$nulls":3},"Pfizer CT.gov Call Center","2018-02-08","2020-05-25T16:39:26.290","2020-05-26T17:10:42.972","NCT03416179"]
["5ecbf4be307e3d1b1f8d9e3f","NCT03416179","2018-03-06","Pfizer","PFE","Not yet recruiting","A Study Evaluating Intensive Chemotherapy With or Without Glasdegib or Azacitidine With or Without Glasdegib In Patients With Previously Untreated Acute Myeloid Leukemia (BRIGHT AML1019)","Glasdegib|Cytarabine|Daunorubicin|Azacitidine","Hh Inhibitor|DNA Polymerase Inhibitor|Nucleic Acid Synthesis Inhibitor|TOP2 Inhibitor|DNA Mtase Inhibitor","Yes","['Glasdegib']","Unknown",null,"Phase 3",4,720,"Anticipated","2018-03-01","2023-01-01","OS","Overall Survival",{"$nulls":3},"Glasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).\n\nGlasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).","Two separate registration trials conducted under one protocol number are proposed to adequately and independently evaluate the addition of glasdegib in intensive and non-intensive chemotherapy populations. Each study will have an experimental treatment arm and a placebo arm. Endpoints are the same for each study except where specifically indicated.\n\nAssignment to the Intensive Study or the Non-Intensive Study will be made by the Investigator based on the 2017 European LeukemiaNet (ELN) recommendations.\n\nStudy B1371019 is a randomized (1:1), double-blind, multi-center, placebo controlled study of chemotherapy in combination with glasdegib versus chemotherapy in combination with placebo in adult patients with previously untreated AML.\n\nGlasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).\n\nGlasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).","A RANDOMIZED (1:1), DOUBLE-BLIND, MULTI-CENTER, PLACEBO CONTROLLED STUDY EVALUATING INTENSIVE CHEMOTHERAPY WITH OR WITHOUT GLASDEGIB (PF-04449913) OR AZACITIDINE (AZA) WITH OR WITHOUT GLASDEGIB IN PATIENTS WITH PREVIOUSLY UNTREATED ACUTE MYELOID LEUKEMIA","B1371019","Leukemia, Myeloid, Acute","Acute Leukemia|Acute Myeloid Leukemia|Myeloid Leukemia|Leukemia","Oncology Hematological","Oncology","Experimental|Placebo Comparator","Arm A (Intensive Study)|Arm B (Intensive Study)|Arm A (Non-intensive study)|Arm B (Non-intensive study)","Glasdegib + '7+3' Induction(s)|Placebo + '7+3' Induction(s)|Glasdegib + azacitidine|Placebo + azacitidine","Drug|Procedure","glasdegib|daunorubicin + cytarabine|cytarabine|HSCT|Placebo|azacitidine","Daily Glasdegib (100 mg, PO), beginning on Day 1 and is to continue up to 2 years post randomization.\n\nFollowing consolidation therapy, glasdegib or placebo will be administered daily for up to 2 years after randomization or until they have minimal residual disease (MRD) negative disease, whichever comes first.\n\nDaily Glasdegib (100 mg, PO) or matching placebo will continue throughout Induction(s) and Consolidation therapies regardless of dose modifications/delays in the chemotherapy.|Consolidation with single agent cytarabine 3 g/m2 IV for adults <60 years and 1 g/m2 for adults 60 years over 3 BID on Days 1, 3, and 5, every 28 days for up to 4 cycles or alternative single agent cytarabine consolidation schedules may be used per local prescribing information.|If required, and done per standard of care post Induction(s).|Azacitidine (75 mg/m2, SC or IV) daily for 7 days, in 28 day cycles for as long as they do not meet the criteria for disease progression, unacceptable toxicity, consent withdrawal, or death.|Matching placebo (PO) is to be administered by mouth daily beginning on Day 1 of chemotherapy and will continue if subjects demonstrate reasonable evidence of clinical benefit and do not meet the criteria for progression regardless of any delays/modifications in the chemotherapy treatment. Subjects will continue placebo until disease progression, unacceptable toxicity, consent withdrawal, or death, whichever comes first.","PF-04449913","Arm A (Intensive Study)|Arm B (Intensive Study)|Arm A (Non-intensive study)|Arm B (Non-intensive study)","\n\nSubjects must meet all of the following inclusion criteria to be eligible for enrollment into the Intensive and Non Intensive study (unless where indicated):\n\n 1.  Subjects with untreated AML according to the World Health Organization (WHO) 2016 Classification2, including those with: * AML arising from MDS or another antecedent hematologic disease (AHD).\n      * AML after previous cytotoxic therapy or radiation (secondary AML).\n     \n     \n 2.  18 years of age (In Japan, 20 years of age).\n 3.  Adequate Organ Function as defined by the following: * Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) 3 x upper limit of normal (ULN), excluding subjects with liver function abnormalities due to underlying malignancy.\n      * Total serum bilirubin 2 x ULN (except subjects with documented Gilbert's syndrome).\n      * Estimated creatinine clearance 30 mL/min as calculated using the standard method for the institution.\n     \n     \n 4.  QTc interval 470 msec using the Fridericia correction (QTcF).\n 5.  All anti cancer treatments (unless specified) should be discontinued 2 weeks from study entry, for example: targeted chemotherapy, radiotherapy, investigational agents, hormones, anagrelide or cytokines. * For control of rapidly progressing leukemia, all trans retinoic acid (ATRA), hydroxyurea, and/or leukopheresis may be used before and for up to 1 week after the first dose of glasdegib.\n     \n     \n 6.  Serum or urine pregnancy test (for female subjects of childbearing potential) with a minimum sensitivity of 25 IU/L or equivalent units of human chorionic gonadotropin (hCG) negative at screening.\n 7.  Male and female subjects of childbearing potential and at risk for pregnancy must agree to use at least one highly effective method of contraception throughout the study and for 180 days after the last dose of azacitidine, cytarabine, or daunorubicin; and the last dose of glasdegib or placebo, whichever occurs later.\n 8.  Female subjects of non childbearing potential must meet at least 1 of the following criteria: 1. Have undergone a documented hysterectomy and/or bilateral oophorectomy;\n      2. Have medically confirmed ovarian failure; or\n      3. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; status may be confirmed by having a serum follicle stimulating hormone (FSH) level confirming the postmenopausal state.\n     \n     All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential.\n     \n     \n 9.  Consent to a saliva sample collection for a germline comparator, unless prohibited by local regulations or ethics committee (EC) decision.\n 10. Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.\n 11. Subjects who are willing and able to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures (including bone marrow [BM] assessments).\n\n","\n\nSubjects with any of the following characteristics/conditions will not be included in the study:\n\n 1.  Acute Promyelocytic Leukemia (APL) and APLwith PML RARA, subjects (WHO 2016 classification).\n 2.  AML with BCR ABL1 or t(9;22)(q34;q11.2) as a sole abnormality. * Complex genetics may include t(9;22) cytogenetic translocation.\n     \n     \n 3.  Subjects with known active CNS leukemia.\n 4.  Participation in other clinical studies involving other investigational drug(s) (Phases 1 4) within 4 weeks prior study entry and/or during study participation.\n 5.  Subjects known to be refractory to platelet or packed red cell transfusions per Institutional Guidelines, or a patient who refuses blood product support.\n 6.  Subjects with another active malignancy on treatment with the exception of basal cell carcinoma, non melanoma skin cancer, cervical carcinoma in situ. Other prior or concurrent malignancies will be considered on a case by case basis.\n 7.  Any one of the following ongoing or in the previous 6 months: myocardial infarction, congenital long QT syndrome, Torsades de pointes, symptomatic arrhythmias (including sustained ventricular tachyarrhythmia), right or left bundle branch block and bifascicular block, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (CHF New York Heart Association class III or IV), cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism; as well as bradycardia defined as <50 bpms.\n 8.  Subjects with an active, life threatening or clinically significant uncontrolled systemic infection not related to AML.\n 9.  Subjects with left ventricular ejection fraction (LVEF) <50% are excluded from the Intensive Chemotherapy Study only.\n 10. Cumulative anthracycline dose equivalent of 550 mg/m2 of daunorubicin for the Intensive Chemotherapy Study only.\n 11. Known malabsorption syndrome or other condition that may significantly impair absorption of study medication in the investigator's judgment (eg, gastrectomy, lap band, Crohn's disease) and inability or unwillingness to swallow tablets or capsules.\n 12. Current use or anticipated requirement for drugs that are known strong CYP3A4/5 inducers.\n 13. Concurrent administration of herbal preparations.\n 14. Major surgery or radiation within 4 weeks of starting study treatment.\n 15. Documented or suspected hypersensitivity to any one of the following: * For subjects assigned to intensive chemotherapy, documented or suspected hypersensitivity to cytarabine (not including drug fever or exanthema, including known cerebellar side effects) or daunorubicin.\n      * For subjects assigned to non intensive chemotherapy, documented or suspected hypersensitivity to azacitidine or mannitol.\n     \n     \n 16. Known active drug or alcohol abuse.\n 17. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.\n 18. Pregnant females or breastfeeding female subjects.\n 19. Known recent or active suicidal ideation or behavior.\n 20. Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.","FSH",null,"Protein","Ovary","Actual","2018-01-31","Actual","Anticipated","2025-02-01","Anticipated","2018-03-01","2017-12-21","2018-01-23","2018-03-02","Yes","glasdegib;\nuntreated;\nHedgehog Inhibitor","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"All",null,"No","Yes\nInformation relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests",null,"URL: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1371019&StudyName=A+Randomized+%281%3A1%29%2C+Double+Blind%2C+Multi+Center%2C+Placebo+Controlled+Study+Evaluating+Intensive+Chemotherapy+With+Or+Without+Glasdegib+%28pf+04449913%29+Or+Azacitidine+%28aza%29+With+Or+Without+Glasdegib+In+Patients+With+Previously+Untreated+Acute+Myeloid+Leukemia [https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1371019&StudyName=A+Randomized+%281%3A1%29%2C+Double+Blind%2C+Multi+Center%2C+Placebo+Controlled+Study+Evaluating+Intensive+Chemotherapy+With+Or+Without+Glasdegib+%28pf+04449913%29+Or+Azacitidine+%28aza%29+With+Or+Without+Glasdegib+In+Patients+With+Previously+Untreated+Acute+Myeloid+Leukemia] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To obtain contact information for a study center near you, click here.",null,"Yes","No",{"$nulls":17},"2017-002822-19|BRIGHT|BRIGHT AML1019","EudraCT Number|Alias Study Number","Overall survival","5 years after last subject randomized",null,"Fatigue score measured by the MD Anderson Symptom Inventory (MDASI)-AML/MDS questionnaire|Rate of Complete Remission (CR) (including CR with minimal residual disease (MRD)-negative as assessed by multiparametric flow cytometry)|Duration of response (defined as CR [includes CR-MRD negative]/CRi or CR/CRh as appropriate)|Time to response (CR[includes CR-MRD negative)]/CR with partial hematologic rcovery (CRh) as appropriate)|Event-free Survival|Patient Reported Outcomes (PROs) as measured by the M.D. Anderson Symptom Inventory AML/MDS Module (MDASI-AML/MDS)|Adverse events as graded by NCI CTCAE v4.03|Laboratory abnormalities as graded by NCI CTCAE v4.03|For the intensive study, the plasma trough concentration (Ctrough) will be analyzed|QTc interval|PROs as measured by Patient Global Impression of Change (PGIC)|Patient Reported Outcomes (PROs) as measured by EuroQoL 5 Dimension questionnaire 5-Level version (EQ-5D-5L)|Patient Reported Outcomes (PROs) as measured by Patient Global Impression of Symptoms (PGIS)|Complete Remission with incomplete hematologic recovery (CRi)|Rate of morphological leukemia-free state (MLFS)|Rate of Partial Remission (PR)|Rate of Complete Remission with partial hematological recovery (CRh) for the Non-intensive study only only|Minimum Observed Plasma Trough Concentratrion of glasdegib in the Intensive Study|Minimum Observed Plasma Trough Concentration of glasdegib in the Non-intensive study","Scale is from 0-10 where 0 is not present and 10 is as bad as you can image.|Response as defined by the 2017 European LeukemiaNet (ELN) recommendations.|5 years after last subject randomized, consent withdrawal, or death|Measurement Scale from 0-10.|PK samples taken on Induction(s) Day 1 (1 and 4 hours post induction); Induction(s) Day 10 (pre-dose, 1 and 4 hours post dose); Day 1 of each Consolidation cycle (pre-dose, 1 and 4 hours post dose)|One question asking for description of leukemia symptoms.|Series of questions that ask for information that best describes health.|One question asking for information regarding leukemia symptoms.|Its the minimum trough concentration in plasma of glasdegib following multiple daily dosing to steady state.|It is the minimum trough concentration in plasma of glasdegib following multiple daily dosing to steady state.","5 years after last subject randomized, consent withdrawal, or death|2 years after last dose of study therapy|5 years after last patient randomized, withdrawal, or death|5 years after last subject randomized, withdrawal, or death|Day 10 of Induction Cycle and Day 1 of each Consolidation Cycle|Cycle 1 Day 15 and Cycles 2 and 3 on Day 1","ClinicalTrials.gov_Inquiries@pfizer.com","Pfizer CT.gov Call Center","1-800-718-1021","Yoshida-Gun, Fukui, Japan, 910-1193|Osaka-City, Osaka, Japan, 545-8586|Sunto-Gun, Shizuoka, Japan, 411-8777|Tachikawa, Tokyo, Japan, 190-0014",null,"Japan","Fukui University Of Fukui Hospital|Osaka Osaka City University Hospital|Shizuoka Shizuoka Cancer Center|Tokyo National Hospital Organization Disaster Medical Center",{"$nulls":3},"Pfizer CT.gov Call Center","2018-03-02","2020-05-25T16:39:26.348","2020-05-26T17:10:42.972","NCT03416179"]
["5ecbf4bee2561b1b11905ea8","NCT03416179","2018-04-18","Pfizer","PFE","Recruiting","A Study Evaluating Intensive Chemotherapy With or Without Glasdegib or Azacitidine With or Without Glasdegib In Patients With Previously Untreated Acute Myeloid Leukemia (BRIGHT AML1019)","Glasdegib|Cytarabine|Daunorubicin|Azacitidine","Hh Inhibitor|DNA Polymerase Inhibitor|Nucleic Acid Synthesis Inhibitor|TOP2 Inhibitor|DNA Mtase Inhibitor","Yes","['Glasdegib']","Unknown",null,"Phase 3",4,720,"Anticipated","2018-04-20","2023-01-23","OS","Overall Survival",{"$nulls":3},"Glasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).\n\nGlasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).","Two separate registration trials conducted under one protocol number are proposed to adequately and independently evaluate the addition of glasdegib in intensive and non-intensive chemotherapy populations. Each study will have an experimental treatment arm and a placebo arm. Endpoints are the same for each study except where specifically indicated.\n\nAssignment to the Intensive Study or the Non-Intensive Study will be made by the Investigator based on the 2017 European LeukemiaNet (ELN) recommendations.\n\nStudy B1371019 is a randomized (1:1), double-blind, multi-center, placebo controlled study of chemotherapy in combination with glasdegib versus chemotherapy in combination with placebo in adult patients with previously untreated AML.\n\nGlasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).\n\nGlasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).","A RANDOMIZED (1:1), DOUBLE-BLIND, MULTI-CENTER, PLACEBO CONTROLLED STUDY EVALUATING INTENSIVE CHEMOTHERAPY WITH OR WITHOUT GLASDEGIB (PF-04449913) OR AZACITIDINE (AZA) WITH OR WITHOUT GLASDEGIB IN PATIENTS WITH PREVIOUSLY UNTREATED ACUTE MYELOID LEUKEMIA","B1371019","Leukemia, Myeloid, Acute","Acute Leukemia|Acute Myeloid Leukemia|Myeloid Leukemia|Leukemia","Oncology Hematological","Oncology","Experimental|Placebo Comparator","Arm A (Intensive Study)|Arm B (Intensive Study)|Arm A (Non-intensive study)|Arm B (Non-intensive study)","Glasdegib + '7+3' Induction(s)|Placebo + '7+3' Induction(s)|Glasdegib + azacitidine|Placebo + azacitidine","Drug|Procedure","glasdegib|daunorubicin + cytarabine|cytarabine|HSCT|Placebo|azacitidine","Daily Glasdegib (100 mg, PO), beginning on Day 1 and is to continue up to 2 years post randomization.\n\nFollowing consolidation therapy, glasdegib or placebo will be administered daily for up to 2 years after randomization or until they have minimal residual disease (MRD) negative disease, whichever comes first.\n\nDaily Glasdegib (100 mg, PO) or matching placebo will continue throughout Induction(s) and Consolidation therapies regardless of dose modifications/delays in the chemotherapy.|Consolidation with single agent cytarabine 3 g/m2 IV for adults <60 years and 1 g/m2 for adults 60 years over 3 BID on Days 1, 3, and 5, every 28 days for up to 4 cycles or alternative single agent cytarabine consolidation schedules may be used per local prescribing information.|If required, and done per standard of care post Induction(s).|Azacitidine (75 mg/m2, SC or IV) daily for 7 days, in 28 day cycles for as long as they do not meet the criteria for disease progression, unacceptable toxicity, consent withdrawal, or death.|Matching placebo (PO) is to be administered by mouth daily beginning on Day 1 of chemotherapy and will continue if subjects demonstrate reasonable evidence of clinical benefit and do not meet the criteria for progression regardless of any delays/modifications in the chemotherapy treatment. Subjects will continue placebo until disease progression, unacceptable toxicity, consent withdrawal, or death, whichever comes first.","PF-04449913","Arm A (Intensive Study)|Arm B (Intensive Study)|Arm A (Non-intensive study)|Arm B (Non-intensive study)","\n\nSubjects must meet all of the following inclusion criteria to be eligible for enrollment into the Intensive and Non Intensive study (unless where indicated):\n\n 1.  Subjects with untreated AML according to the World Health Organization (WHO) 2016 Classification2, including those with: * AML arising from MDS or another antecedent hematologic disease (AHD).\n      * AML after previous cytotoxic therapy or radiation (secondary AML).\n     \n     \n 2.  18 years of age (In Japan, 20 years of age).\n 3.  Adequate Organ Function as defined by the following: * Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) 3 x upper limit of normal (ULN), excluding subjects with liver function abnormalities due to underlying malignancy.\n      * Total serum bilirubin 2 x ULN (except subjects with documented Gilbert's syndrome).\n      * Estimated creatinine clearance 30 mL/min as calculated using the standard method for the institution.\n     \n     \n 4.  QTc interval 470 msec using the Fridericia correction (QTcF).\n 5.  All anti cancer treatments (unless specified) should be discontinued 2 weeks from study entry, for example: targeted chemotherapy, radiotherapy, investigational agents, hormones, anagrelide or cytokines. * For control of rapidly progressing leukemia, all trans retinoic acid (ATRA), hydroxyurea, and/or leukopheresis may be used before and for up to 1 week after the first dose of glasdegib.\n     \n     \n 6.  Serum or urine pregnancy test (for female subjects of childbearing potential) with a minimum sensitivity of 25 IU/L or equivalent units of human chorionic gonadotropin (hCG) negative at screening.\n 7.  Male and female subjects of childbearing potential and at risk for pregnancy must agree to use at least one highly effective method of contraception throughout the study and for 180 days after the last dose of azacitidine, cytarabine, or daunorubicin; and the last dose of glasdegib or placebo, whichever occurs later.\n 8.  Female subjects of non childbearing potential must meet at least 1 of the following criteria: 1. Have undergone a documented hysterectomy and/or bilateral oophorectomy;\n      2. Have medically confirmed ovarian failure; or\n      3. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; status may be confirmed by having a serum follicle stimulating hormone (FSH) level confirming the postmenopausal state.\n     \n     All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential.\n     \n     \n 9.  Consent to a saliva sample collection for a germline comparator, unless prohibited by local regulations or ethics committee (EC) decision.\n 10. Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.\n 11. Subjects who are willing and able to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures (including bone marrow [BM] assessments).\n\n","\n\nSubjects with any of the following characteristics/conditions will not be included in the study:\n\n 1.  Acute Promyelocytic Leukemia (APL) and APLwith PML RARA, subjects (WHO 2016 classification).\n 2.  AML with BCR ABL1 or t(9;22)(q34;q11.2) as a sole abnormality. * Complex genetics may include t(9;22) cytogenetic translocation.\n     \n     \n 3.  Subjects with known active CNS leukemia.\n 4.  Participation in other clinical studies involving other investigational drug(s) (Phases 1 4) within 4 weeks prior study entry and/or during study participation.\n 5.  Subjects known to be refractory to platelet or packed red cell transfusions per Institutional Guidelines, or a patient who refuses blood product support.\n 6.  Subjects with another active malignancy on treatment with the exception of basal cell carcinoma, non melanoma skin cancer, cervical carcinoma in situ. Other prior or concurrent malignancies will be considered on a case by case basis.\n 7.  Any one of the following ongoing or in the previous 6 months: myocardial infarction, congenital long QT syndrome, Torsades de pointes, symptomatic arrhythmias (including sustained ventricular tachyarrhythmia), right or left bundle branch block and bifascicular block, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (CHF New York Heart Association class III or IV), cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism; as well as bradycardia defined as <50 bpms.\n 8.  Subjects with an active, life threatening or clinically significant uncontrolled systemic infection not related to AML.\n 9.  Subjects with left ventricular ejection fraction (LVEF) <50% are excluded from the Intensive Chemotherapy Study only.\n 10. Cumulative anthracycline dose equivalent of 550 mg/m2 of daunorubicin for the Intensive Chemotherapy Study only.\n 11. Known malabsorption syndrome or other condition that may significantly impair absorption of study medication in the investigator's judgment (eg, gastrectomy, lap band, Crohn's disease) and inability or unwillingness to swallow tablets or capsules.\n 12. Current use or anticipated requirement for drugs that are known strong CYP3A4/5 inducers.\n 13. Concurrent administration of herbal preparations.\n 14. Major surgery or radiation within 4 weeks of starting study treatment.\n 15. Documented or suspected hypersensitivity to any one of the following: * For subjects assigned to intensive chemotherapy, documented or suspected hypersensitivity to cytarabine (not including drug fever or exanthema, including known cerebellar side effects) or daunorubicin.\n      * For subjects assigned to non intensive chemotherapy, documented or suspected hypersensitivity to azacitidine or mannitol.\n     \n     \n 16. Known active drug or alcohol abuse.\n 17. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.\n 18. Pregnant females or breastfeeding female subjects.\n 19. Known recent or active suicidal ideation or behavior.\n 20. Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.","FSH",null,"Protein","Ovary","Actual","2018-01-31","Actual","Anticipated","2025-02-28","Anticipated","2018-04-01","2017-12-21","2018-01-23","2018-04-17","Yes","glasdegib;\nuntreated;\nHedgehog Inhibitor","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"All",null,"No","Yes\nInformation relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests",null,"URL: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1371019&StudyName=A+Randomized+%281%3A1%29%2C+Double+Blind%2C+Multi+Center%2C+Placebo+Controlled+Study+Evaluating+Intensive+Chemotherapy+With+Or+Without+Glasdegib+%28pf+04449913%29+Or+Azacitidine+%28aza%29+With+Or+Without+Glasdegib+In+Patients+With+Previously+Untreated+Acute+Myeloid+Leukemia [https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1371019&StudyName=A+Randomized+%281%3A1%29%2C+Double+Blind%2C+Multi+Center%2C+Placebo+Controlled+Study+Evaluating+Intensive+Chemotherapy+With+Or+Without+Glasdegib+%28pf+04449913%29+Or+Azacitidine+%28aza%29+With+Or+Without+Glasdegib+In+Patients+With+Previously+Untreated+Acute+Myeloid+Leukemia] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To obtain contact information for a study center near you, click here.",null,"Yes","No",{"$nulls":17},"2017-002822-19|BRIGHT|BRIGHT AML1019","EudraCT Number|Alias Study Number","Overall survival","5 years after last subject randomized",null,"Fatigue score measured by the MD Anderson Symptom Inventory (MDASI)-AML/MDS questionnaire|Rate of Complete Remission (CR) (including CR with minimal residual disease (MRD)-negative as assessed by multiparametric flow cytometry)|Duration of response (defined as CR [includes CR-MRD negative]/CRi or CR/CRh as appropriate)|Time to response (CR[includes CR-MRD negative)]/CR with partial hematologic rcovery (CRh) as appropriate)|Event-free Survival|Patient Reported Outcomes (PROs) as measured by the M.D. Anderson Symptom Inventory AML/MDS Module (MDASI-AML/MDS)|Adverse events as graded by NCI CTCAE v4.03|Laboratory abnormalities as graded by NCI CTCAE v4.03|For the intensive study, the plasma trough concentration (Ctrough) will be analyzed|QTc interval|PROs as measured by Patient Global Impression of Change (PGIC)|Patient Reported Outcomes (PROs) as measured by EuroQoL 5 Dimension questionnaire 5-Level version (EQ-5D-5L)|Patient Reported Outcomes (PROs) as measured by Patient Global Impression of Symptoms (PGIS)|Complete Remission with incomplete hematologic recovery (CRi)|Rate of morphological leukemia-free state (MLFS)|Rate of Partial Remission (PR)|Rate of Complete Remission with partial hematological recovery (CRh) for the Non-intensive study only only|Minimum Observed Plasma Trough Concentratrion of glasdegib in the Intensive Study|Minimum Observed Plasma Trough Concentration of glasdegib in the Non-intensive study","Scale is from 0-10 where 0 is not present and 10 is as bad as you can image.|Response as defined by the 2017 European LeukemiaNet (ELN) recommendations.|5 years after last subject randomized, consent withdrawal, or death|Measurement Scale from 0-10.|PK samples taken on Induction(s) Day 1 (1 and 4 hours post induction); Induction(s) Day 10 (pre-dose, 1 and 4 hours post dose); Day 1 of each Consolidation cycle (pre-dose, 1 and 4 hours post dose)|One question asking for description of leukemia symptoms.|Series of questions that ask for information that best describes health.|One question asking for information regarding leukemia symptoms.|Its the minimum trough concentration in plasma of glasdegib following multiple daily dosing to steady state.|It is the minimum trough concentration in plasma of glasdegib following multiple daily dosing to steady state.","5 years after last subject randomized, consent withdrawal, or death|2 years after last dose of study therapy|5 years after last patient randomized, withdrawal, or death|5 years after last subject randomized, withdrawal, or death|Day 10 of Induction Cycle and Day 1 of each Consolidation Cycle|Cycle 1 Day 15 and Cycles 2 and 3 on Day 1","ClinicalTrials.gov_Inquiries@pfizer.com","Pfizer CT.gov Call Center","1-800-718-1021","Akita, Japan, 010-8543 Nagasaki University HospitalNagasaki, Japan, 852-8501|Yoshida-Gun, Fukui, Japan, 910-1193|Maebashi, Gunma, Japan, 371-8511|Kobe-Shi, Hyogo, Japan, 650-0017|Sendai, Miyagi, Japan, 980-8574|Osaka-City, Osaka, Japan, 545-8586|Sunto-Gun, Shizuoka, Japan, 411-8777|Tachikawa, Tokyo, Japan, 190-0014",null,"Japan","Akita University Hospital|Fukui University Of Fukui Hospital|Gunma Gunma University Hospital|Hyogo Kobe University Hospital|Miyagi Tohoku University Hospital|Osaka Osaka City University Hospital|Shizuoka Shizuoka Cancer Center|Tokyo National Hospital Organization Disaster Medical Center",{"$nulls":3},"Pfizer CT.gov Call Center","2018-04-17","2020-05-25T16:39:26.670","2020-05-26T17:10:42.972","NCT03416179"]
["5ecbf4befeab101b155309de","NCT03416179","2018-05-17","Pfizer","PFE","Recruiting","A Study Evaluating Intensive Chemotherapy With or Without Glasdegib or Azacitidine With or Without Glasdegib In Patients With Previously Untreated Acute Myeloid Leukemia (BRIGHT AML1019)","Glasdegib|Cytarabine|Daunorubicin|Azacitidine","Hh Inhibitor|DNA Polymerase Inhibitor|Nucleic Acid Synthesis Inhibitor|TOP2 Inhibitor|DNA Mtase Inhibitor","Yes","['Glasdegib']","Unknown",null,"Phase 3",4,720,"Anticipated","2018-04-20","2023-01-17","OS","Overall Survival",{"$nulls":3},"Glasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).\n\nGlasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).","Two separate registration trials conducted under one protocol number are proposed to adequately and independently evaluate the addition of glasdegib in intensive and non-intensive chemotherapy populations. Each study will have an experimental treatment arm and a placebo arm. Endpoints are the same for each study except where specifically indicated.\n\nAssignment to the Intensive Study or the Non-Intensive Study will be made by the Investigator based on the 2017 European LeukemiaNet (ELN) recommendations.\n\nStudy B1371019 is a randomized (1:1), double-blind, multi-center, placebo controlled study of chemotherapy in combination with glasdegib versus chemotherapy in combination with placebo in adult patients with previously untreated AML.\n\nGlasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).\n\nGlasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).","A RANDOMIZED (1:1), DOUBLE-BLIND, MULTI-CENTER, PLACEBO CONTROLLED STUDY EVALUATING INTENSIVE CHEMOTHERAPY WITH OR WITHOUT GLASDEGIB (PF-04449913) OR AZACITIDINE (AZA) WITH OR WITHOUT GLASDEGIB IN PATIENTS WITH PREVIOUSLY UNTREATED ACUTE MYELOID LEUKEMIA","B1371019","Leukemia, Myeloid, Acute","Acute Leukemia|Acute Myeloid Leukemia|Myeloid Leukemia|Leukemia","Oncology Hematological","Oncology","Experimental|Placebo Comparator","Arm A (Intensive Study)|Arm B (Intensive Study)|Arm A (Non-intensive study)|Arm B (Non-intensive study)","Glasdegib + '7+3' Induction(s)|Placebo + '7+3' Induction(s)|Glasdegib + azacitidine|Placebo + azacitidine","Drug|Procedure","glasdegib|daunorubicin + cytarabine|cytarabine|HSCT|Placebo|azacitidine","Daily Glasdegib (100 mg, PO), beginning on Day 1 and is to continue up to 2 years post randomization.\n\nFollowing consolidation therapy, glasdegib or placebo will be administered daily for up to 2 years after randomization or until they have minimal residual disease (MRD) negative disease, whichever comes first.\n\nDaily Glasdegib (100 mg, PO) or matching placebo will continue throughout Induction(s) and Consolidation therapies regardless of dose modifications/delays in the chemotherapy.|Consolidation with single agent cytarabine 3 g/m2 IV for adults <60 years and 1 g/m2 for adults 60 years over 3 BID on Days 1, 3, and 5, every 28 days for up to 4 cycles or alternative single agent cytarabine consolidation schedules may be used per local prescribing information.|If required, and done per standard of care post Induction(s).|Azacitidine (75 mg/m2, SC or IV) daily for 7 days, in 28 day cycles for as long as they do not meet the criteria for disease progression, unacceptable toxicity, consent withdrawal, or death.|Matching placebo (PO) is to be administered by mouth daily beginning on Day 1 of chemotherapy and will continue if subjects demonstrate reasonable evidence of clinical benefit and do not meet the criteria for progression regardless of any delays/modifications in the chemotherapy treatment. Subjects will continue placebo until disease progression, unacceptable toxicity, consent withdrawal, or death, whichever comes first.","PF-04449913","Arm A (Intensive Study)|Arm B (Intensive Study)|Arm A (Non-intensive study)|Arm B (Non-intensive study)","\n\nSubjects must meet all of the following inclusion criteria to be eligible for enrollment into the Intensive and Non Intensive study (unless where indicated):\n\n 1.  Subjects with untreated AML according to the World Health Organization (WHO) 2016 Classification2, including those with: * AML arising from MDS or another antecedent hematologic disease (AHD).\n      * AML after previous cytotoxic therapy or radiation (secondary AML).\n     \n     \n 2.  18 years of age (In Japan, 20 years of age).\n 3.  Adequate Organ Function as defined by the following: * Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) 3 x upper limit of normal (ULN), excluding subjects with liver function abnormalities due to underlying malignancy.\n      * Total serum bilirubin 2 x ULN (except subjects with documented Gilbert's syndrome).\n      * Estimated creatinine clearance 30 mL/min as calculated using the standard method for the institution.\n     \n     \n 4.  QTc interval 470 msec using the Fridericia correction (QTcF).\n 5.  All anti cancer treatments (unless specified) should be discontinued 2 weeks from study entry, for example: targeted chemotherapy, radiotherapy, investigational agents, hormones, anagrelide or cytokines. * For control of rapidly progressing leukemia, all trans retinoic acid (ATRA), hydroxyurea, and/or leukopheresis may be used before and for up to 1 week after the first dose of glasdegib.\n     \n     \n 6.  Serum or urine pregnancy test (for female subjects of childbearing potential) with a minimum sensitivity of 25 IU/L or equivalent units of human chorionic gonadotropin (hCG) negative at screening.\n 7.  Male and female subjects of childbearing potential and at risk for pregnancy must agree to use at least one highly effective method of contraception throughout the study and for 180 days after the last dose of azacitidine, cytarabine, or daunorubicin; and the last dose of glasdegib or placebo, whichever occurs later.\n 8.  Female subjects of non childbearing potential must meet at least 1 of the following criteria: 1. Have undergone a documented hysterectomy and/or bilateral oophorectomy;\n      2. Have medically confirmed ovarian failure; or\n      3. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; status may be confirmed by having a serum follicle stimulating hormone (FSH) level confirming the postmenopausal state.\n     \n     All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential.\n     \n     \n 9.  Consent to a saliva sample collection for a germline comparator, unless prohibited by local regulations or ethics committee (EC) decision.\n 10. Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.\n 11. Subjects who are willing and able to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures (including bone marrow [BM] assessments).\n\n","\n\nSubjects with any of the following characteristics/conditions will not be included in the study:\n\n 1.  Acute Promyelocytic Leukemia (APL) and APLwith PML RARA, subjects (WHO 2016 classification).\n 2.  AML with BCR ABL1 or t(9;22)(q34;q11.2) as a sole abnormality. * Complex genetics may include t(9;22) cytogenetic translocation.\n     \n     \n 3.  Subjects with known active CNS leukemia.\n 4.  Participation in other clinical studies involving other investigational drug(s) (Phases 1 4) within 4 weeks prior study entry and/or during study participation.\n 5.  Subjects known to be refractory to platelet or packed red cell transfusions per Institutional Guidelines, or a patient who refuses blood product support.\n 6.  Subjects with another active malignancy on treatment with the exception of basal cell carcinoma, non melanoma skin cancer, cervical carcinoma in situ. Other prior or concurrent malignancies will be considered on a case by case basis.\n 7.  Any one of the following ongoing or in the previous 6 months: myocardial infarction, congenital long QT syndrome, Torsades de pointes, symptomatic arrhythmias (including sustained ventricular tachyarrhythmia), right or left bundle branch block and bifascicular block, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (CHF New York Heart Association class III or IV), cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism; as well as bradycardia defined as <50 bpms.\n 8.  Subjects with an active, life threatening or clinically significant uncontrolled systemic infection not related to AML.\n 9.  Subjects with left ventricular ejection fraction (LVEF) <50% are excluded from the Intensive Chemotherapy Study only.\n 10. Cumulative anthracycline dose equivalent of 550 mg/m2 of daunorubicin for the Intensive Chemotherapy Study only.\n 11. Known malabsorption syndrome or other condition that may significantly impair absorption of study medication in the investigator's judgment (eg, gastrectomy, lap band, Crohn's disease) and inability or unwillingness to swallow tablets or capsules.\n 12. Current use or anticipated requirement for drugs that are known strong CYP3A4/5 inducers.\n 13. Concurrent administration of herbal preparations.\n 14. Major surgery or radiation within 4 weeks of starting study treatment.\n 15. Documented or suspected hypersensitivity to any one of the following: * For subjects assigned to intensive chemotherapy, documented or suspected hypersensitivity to cytarabine (not including drug fever or exanthema, including known cerebellar side effects) or daunorubicin.\n      * For subjects assigned to non intensive chemotherapy, documented or suspected hypersensitivity to azacitidine or mannitol.\n     \n     \n 16. Known active drug or alcohol abuse.\n 17. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.\n 18. Pregnant females or breastfeeding female subjects.\n 19. Known recent or active suicidal ideation or behavior.\n 20. Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.","FSH",null,"Protein","Ovary","Actual","2018-01-31","Actual","Anticipated","2025-02-28","Anticipated","2018-05-01","2017-12-21","2018-01-23","2018-05-16","Yes","glasdegib;\nuntreated;\nHedgehog Inhibitor","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"All",null,"No","Yes\nInformation relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests",null,"URL: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1371019&StudyName=A+Randomized+%281%3A1%29%2C+Double+Blind%2C+Multi+Center%2C+Placebo+Controlled+Study+Evaluating+Intensive+Chemotherapy+With+Or+Without+Glasdegib+%28pf+04449913%29+Or+Azacitidine+%28aza%29+With+Or+Without+Glasdegib+In+Patients+With+Previously+Untreated+Acute+Myeloid+Leukemia [https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1371019&StudyName=A+Randomized+%281%3A1%29%2C+Double+Blind%2C+Multi+Center%2C+Placebo+Controlled+Study+Evaluating+Intensive+Chemotherapy+With+Or+Without+Glasdegib+%28pf+04449913%29+Or+Azacitidine+%28aza%29+With+Or+Without+Glasdegib+In+Patients+With+Previously+Untreated+Acute+Myeloid+Leukemia] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To obtain contact information for a study center near you, click here.",null,"Yes","No",{"$nulls":17},"2017-002822-19|BRIGHT|BRIGHT AML1019","EudraCT Number|Alias Study Number","Overall survival","5 years after last subject randomized",null,"Fatigue score measured by the MD Anderson Symptom Inventory (MDASI)-AML/MDS questionnaire|Rate of Complete Remission (CR) (including CR with minimal residual disease (MRD)-negative as assessed by multiparametric flow cytometry)|Duration of response (defined as CR [includes CR-MRD negative]/CRi or CR/CRh as appropriate)|Time to response (CR[includes CR-MRD negative)]/CR with partial hematologic rcovery (CRh) as appropriate)|Event-free Survival|Patient Reported Outcomes (PROs) as measured by the M.D. Anderson Symptom Inventory AML/MDS Module (MDASI-AML/MDS)|Adverse events as graded by NCI CTCAE v4.03|Laboratory abnormalities as graded by NCI CTCAE v4.03|For the intensive study, the plasma trough concentration (Ctrough) will be analyzed|QTc interval|PROs as measured by Patient Global Impression of Change (PGIC)|Patient Reported Outcomes (PROs) as measured by EuroQoL 5 Dimension questionnaire 5-Level version (EQ-5D-5L)|Patient Reported Outcomes (PROs) as measured by Patient Global Impression of Symptoms (PGIS)|Complete Remission with incomplete hematologic recovery (CRi)|Rate of morphological leukemia-free state (MLFS)|Rate of Partial Remission (PR)|Rate of Complete Remission with partial hematological recovery (CRh) for the Non-intensive study only only|Minimum Observed Plasma Trough Concentratrion of glasdegib in the Intensive Study|Minimum Observed Plasma Trough Concentration of glasdegib in the Non-intensive study","Scale is from 0-10 where 0 is not present and 10 is as bad as you can image.|Response as defined by the 2017 European LeukemiaNet (ELN) recommendations.|5 years after last subject randomized, consent withdrawal, or death|Measurement Scale from 0-10.|PK samples taken on Induction(s) Day 1 (1 and 4 hours post induction); Induction(s) Day 10 (pre-dose, 1 and 4 hours post dose); Day 1 of each Consolidation cycle (pre-dose, 1 and 4 hours post dose)|One question asking for description of leukemia symptoms.|Series of questions that ask for information that best describes health.|One question asking for information regarding leukemia symptoms.|Its the minimum trough concentration in plasma of glasdegib following multiple daily dosing to steady state.|It is the minimum trough concentration in plasma of glasdegib following multiple daily dosing to steady state.","5 years after last subject randomized, consent withdrawal, or death|2 years after last dose of study therapy|5 years after last patient randomized, withdrawal, or death|5 years after last subject randomized, withdrawal, or death|Day 10 of Induction Cycle and Day 1 of each Consolidation Cycle|Cycle 1 Day 15 and Cycles 2 and 3 on Day 1","ClinicalTrials.gov_Inquiries@pfizer.com","Pfizer CT.gov Call Center","1-800-718-1021","Nagoya, Aichi, Japan, 466-8650|Akita, Japan, 010-8543 Kyushu University HospitalFukuoka, Japan, 812-8582 Nagasaki University HospitalNagasaki, Japan, 852-8501 Tokyo Medical University HospitalTokyo, Japan, 160-0023 Korea, Republic Of, Jeollabuk-Do Chonbuk National University Hospital (Drug Shipment Only)Jeonju-Si, Jeollabuk-Do, Korea, Republic Of, 54907 Chonbuk National University HospitalJeonju-Si, Jeollabuk-Do, Korea, Republic Of, 54907 Taiwan Department Of Clinical Trial Pharmacy, Taipei Veterans General HospitalTaipei, Taiwan, 11217 Taipei Veterans General HospitalTaipei, Taiwan, 11217|Yoshida-Gun, Fukui, Japan, 910-1193|Maebashi, Gunma, Japan, 371-8511|Kobe-Shi, Hyogo, Japan, 650-0017|Yokohama, Kanagawa, Japan, 232-0024|Sendai, Miyagi, Japan, 980-8574|Osaka-City, Osaka, Japan, 545-8586|Sunto-Gun, Shizuoka, Japan, 411-8777|Tachikawa, Tokyo, Japan, 190-0014",null,"Japan","Aichi Japanese Red Cross Nagoya Daini Hospital|Akita University Hospital|Fukui University Of Fukui Hospital|Gunma Gunma University Hospital|Hyogo Kobe University Hospital|Kanagawa Yokohama City University Medical Center|Miyagi Tohoku University Hospital|Osaka Osaka City University Hospital|Shizuoka Shizuoka Cancer Center|Tokyo National Hospital Organization Disaster Medical Center",{"$nulls":3},"Pfizer CT.gov Call Center","2018-05-16","2020-05-25T16:39:26.997","2020-05-26T17:10:42.972","NCT03416179"]
["5ecbf4bf11702c1b1b916bbc","NCT03416179","2018-05-29","Pfizer","PFE","Recruiting","A Study Evaluating Intensive Chemotherapy With or Without Glasdegib or Azacitidine With or Without Glasdegib In Patients With Previously Untreated Acute Myeloid Leukemia (BRIGHT AML1019)","Glasdegib|Cytarabine|Daunorubicin|Azacitidine","Hh Inhibitor|DNA Polymerase Inhibitor|Nucleic Acid Synthesis Inhibitor|TOP2 Inhibitor|DNA Mtase Inhibitor","Yes","['Glasdegib']","Unknown",null,"Phase 3",4,720,"Anticipated","2018-04-20","2023-01-17","OS","Overall Survival",{"$nulls":3},"Glasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).\n\nGlasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).","Two separate registration trials conducted under one protocol number are proposed to adequately and independently evaluate the addition of glasdegib in intensive and non-intensive chemotherapy populations. Each study will have an experimental treatment arm and a placebo arm. Endpoints are the same for each study except where specifically indicated.\n\nAssignment to the Intensive Study or the Non-Intensive Study will be made by the Investigator based on the 2017 European LeukemiaNet (ELN) recommendations.\n\nStudy B1371019 is a randomized (1:1), double-blind, multi-center, placebo controlled study of chemotherapy in combination with glasdegib versus chemotherapy in combination with placebo in adult patients with previously untreated AML.\n\nGlasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).\n\nGlasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).","A RANDOMIZED (1:1), DOUBLE-BLIND, MULTI-CENTER, PLACEBO CONTROLLED STUDY EVALUATING INTENSIVE CHEMOTHERAPY WITH OR WITHOUT GLASDEGIB (PF-04449913) OR AZACITIDINE (AZA) WITH OR WITHOUT GLASDEGIB IN PATIENTS WITH PREVIOUSLY UNTREATED ACUTE MYELOID LEUKEMIA","B1371019","Leukemia, Myeloid, Acute","Acute Leukemia|Acute Myeloid Leukemia|Myeloid Leukemia|Leukemia","Oncology Hematological","Oncology","Experimental|Placebo Comparator","Arm A (Intensive Study)|Arm B (Intensive Study)|Arm A (Non-intensive study)|Arm B (Non-intensive study)","Glasdegib + '7+3' Induction(s)|Placebo + '7+3' Induction(s)|Glasdegib + azacitidine|Placebo + azacitidine","Drug|Procedure","glasdegib|daunorubicin + cytarabine|cytarabine|HSCT|Placebo|azacitidine","Daily Glasdegib (100 mg, PO), beginning on Day 1 and is to continue up to 2 years post randomization.\n\nFollowing consolidation therapy, glasdegib or placebo will be administered daily for up to 2 years after randomization or until they have minimal residual disease (MRD) negative disease, whichever comes first.\n\nDaily Glasdegib (100 mg, PO) or matching placebo will continue throughout Induction(s) and Consolidation therapies regardless of dose modifications/delays in the chemotherapy.|Consolidation with single agent cytarabine 3 g/m2 IV for adults <60 years and 1 g/m2 for adults 60 years over 3 BID on Days 1, 3, and 5, every 28 days for up to 4 cycles or alternative single agent cytarabine consolidation schedules may be used per local prescribing information.|If required, and done per standard of care post Induction(s).|Azacitidine (75 mg/m2, SC or IV) daily for 7 days, in 28 day cycles for as long as they do not meet the criteria for disease progression, unacceptable toxicity, consent withdrawal, or death.|Matching placebo (PO) is to be administered by mouth daily beginning on Day 1 of chemotherapy and will continue if subjects demonstrate reasonable evidence of clinical benefit and do not meet the criteria for progression regardless of any delays/modifications in the chemotherapy treatment. Subjects will continue placebo until disease progression, unacceptable toxicity, consent withdrawal, or death, whichever comes first.","PF-04449913","Arm A (Intensive Study)|Arm B (Intensive Study)|Arm A (Non-intensive study)|Arm B (Non-intensive study)","\n\nSubjects must meet all of the following inclusion criteria to be eligible for enrollment into the Intensive and Non Intensive study (unless where indicated):\n\n 1.  Subjects with untreated AML according to the World Health Organization (WHO) 2016 Classification2, including those with: * AML arising from MDS or another antecedent hematologic disease (AHD).\n      * AML after previous cytotoxic therapy or radiation (secondary AML).\n     \n     \n 2.  18 years of age (In Japan, 20 years of age).\n 3.  Adequate Organ Function as defined by the following: * Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) 3 x upper limit of normal (ULN), excluding subjects with liver function abnormalities due to underlying malignancy.\n      * Total serum bilirubin 2 x ULN (except subjects with documented Gilbert's syndrome).\n      * Estimated creatinine clearance 30 mL/min as calculated using the standard method for the institution.\n     \n     \n 4.  QTc interval 470 msec using the Fridericia correction (QTcF).\n 5.  All anti cancer treatments (unless specified) should be discontinued 2 weeks from study entry, for example: targeted chemotherapy, radiotherapy, investigational agents, hormones, anagrelide or cytokines. * For control of rapidly progressing leukemia, all trans retinoic acid (ATRA), hydroxyurea, and/or leukopheresis may be used before and for up to 1 week after the first dose of glasdegib.\n     \n     \n 6.  Serum or urine pregnancy test (for female subjects of childbearing potential) with a minimum sensitivity of 25 IU/L or equivalent units of human chorionic gonadotropin (hCG) negative at screening.\n 7.  Male and female subjects of childbearing potential and at risk for pregnancy must agree to use at least one highly effective method of contraception throughout the study and for 180 days after the last dose of azacitidine, cytarabine, or daunorubicin; and the last dose of glasdegib or placebo, whichever occurs later.\n 8.  Female subjects of non childbearing potential must meet at least 1 of the following criteria: 1. Have undergone a documented hysterectomy and/or bilateral oophorectomy;\n      2. Have medically confirmed ovarian failure; or\n      3. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; status may be confirmed by having a serum follicle stimulating hormone (FSH) level confirming the postmenopausal state.\n     \n     All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential.\n     \n     \n 9.  Consent to a saliva sample collection for a germline comparator, unless prohibited by local regulations or ethics committee (EC) decision.\n 10. Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.\n 11. Subjects who are willing and able to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures (including bone marrow [BM] assessments).\n\n","\n\nSubjects with any of the following characteristics/conditions will not be included in the study:\n\n 1.  Acute Promyelocytic Leukemia (APL) and APLwith PML RARA, subjects (WHO 2016 classification).\n 2.  AML with BCR ABL1 or t(9;22)(q34;q11.2) as a sole abnormality. * Complex genetics may include t(9;22) cytogenetic translocation.\n     \n     \n 3.  Subjects with known active CNS leukemia.\n 4.  Participation in other clinical studies involving other investigational drug(s) (Phases 1 4) within 4 weeks prior study entry and/or during study participation.\n 5.  Subjects known to be refractory to platelet or packed red cell transfusions per Institutional Guidelines, or a patient who refuses blood product support.\n 6.  Subjects with another active malignancy on treatment with the exception of basal cell carcinoma, non melanoma skin cancer, cervical carcinoma in situ. Other prior or concurrent malignancies will be considered on a case by case basis.\n 7.  Any one of the following ongoing or in the previous 6 months: myocardial infarction, congenital long QT syndrome, Torsades de pointes, symptomatic arrhythmias (including sustained ventricular tachyarrhythmia), right or left bundle branch block and bifascicular block, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (CHF New York Heart Association class III or IV), cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism; as well as bradycardia defined as <50 bpms.\n 8.  Subjects with an active, life threatening or clinically significant uncontrolled systemic infection not related to AML.\n 9.  Subjects with left ventricular ejection fraction (LVEF) <50% are excluded from the Intensive Chemotherapy Study only.\n 10. Cumulative anthracycline dose equivalent of 550 mg/m2 of daunorubicin for the Intensive Chemotherapy Study only.\n 11. Known malabsorption syndrome or other condition that may significantly impair absorption of study medication in the investigator's judgment (eg, gastrectomy, lap band, Crohn's disease) and inability or unwillingness to swallow tablets or capsules.\n 12. Current use or anticipated requirement for drugs that are known strong CYP3A4/5 inducers.\n 13. Concurrent administration of herbal preparations.\n 14. Major surgery or radiation within 4 weeks of starting study treatment.\n 15. Documented or suspected hypersensitivity to any one of the following: * For subjects assigned to intensive chemotherapy, documented or suspected hypersensitivity to cytarabine (not including drug fever or exanthema, including known cerebellar side effects) or daunorubicin.\n      * For subjects assigned to non intensive chemotherapy, documented or suspected hypersensitivity to azacitidine or mannitol.\n     \n     \n 16. Known active drug or alcohol abuse.\n 17. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.\n 18. Pregnant females or breastfeeding female subjects.\n 19. Known recent or active suicidal ideation or behavior.\n 20. Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.","FSH",null,"Protein","Ovary","Actual","2018-01-31","Actual","Anticipated","2025-07-08","Anticipated","2018-05-01","2017-12-21","2018-01-23","2018-05-25","Yes","glasdegib;\nuntreated;\nHedgehog Inhibitor","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"All",null,"No","Yes\nInformation relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests",null,"URL: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1371019&StudyName=A+Randomized+%281%3A1%29%2C+Double+Blind%2C+Multi+Center%2C+Placebo+Controlled+Study+Evaluating+Intensive+Chemotherapy+With+Or+Without+Glasdegib+%28pf+04449913%29+Or+Azacitidine+%28aza%29+With+Or+Without+Glasdegib+In+Patients+With+Previously+Untreated+Acute+Myeloid+Leukemia [https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1371019&StudyName=A+Randomized+%281%3A1%29%2C+Double+Blind%2C+Multi+Center%2C+Placebo+Controlled+Study+Evaluating+Intensive+Chemotherapy+With+Or+Without+Glasdegib+%28pf+04449913%29+Or+Azacitidine+%28aza%29+With+Or+Without+Glasdegib+In+Patients+With+Previously+Untreated+Acute+Myeloid+Leukemia] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To obtain contact information for a study center near you, click here.",null,"Yes","No",{"$nulls":17},"2017-002822-19|BRIGHT|BRIGHT AML1019","EudraCT Number|Alias Study Number","Overall survival","5 years after last subject randomized",null,"Fatigue score measured by the MD Anderson Symptom Inventory (MDASI)-AML/MDS questionnaire|Rate of Complete Remission (CR) (including CR with minimal residual disease (MRD)-negative as assessed by multiparametric flow cytometry)|Duration of response (defined as CR [includes CR-MRD negative]/CRi or CR/CRh as appropriate)|Time to response (CR[includes CR-MRD negative)]/CR with partial hematologic rcovery (CRh) as appropriate)|Event-free Survival|Patient Reported Outcomes (PROs) as measured by the M.D. Anderson Symptom Inventory AML/MDS Module (MDASI-AML/MDS)|Adverse events as graded by NCI CTCAE v4.03|Laboratory abnormalities as graded by NCI CTCAE v4.03|For the intensive study, the plasma trough concentration (Ctrough) will be analyzed|QTc interval|PROs as measured by Patient Global Impression of Change (PGIC)|Patient Reported Outcomes (PROs) as measured by EuroQoL 5 Dimension questionnaire 5-Level version (EQ-5D-5L)|Patient Reported Outcomes (PROs) as measured by Patient Global Impression of Symptoms (PGIS)|Complete Remission with incomplete hematologic recovery (CRi)|Rate of morphological leukemia-free state (MLFS)|Rate of Partial Remission (PR)|Rate of Complete Remission with partial hematological recovery (CRh) for the Non-intensive study only only|Minimum Observed Plasma Trough Concentratrion of glasdegib in the Intensive Study|Minimum Observed Plasma Trough Concentration of glasdegib in the Non-intensive study","Scale is from 0-10 where 0 is not present and 10 is as bad as you can image.|Response as defined by the 2017 European LeukemiaNet (ELN) recommendations.|5 years after last subject randomized, consent withdrawal, or death|Measurement Scale from 0-10.|PK samples taken on Induction(s) Day 1 (1 and 4 hours post induction); Induction(s) Day 10 (pre-dose, 1 and 4 hours post dose); Day 1 of each Consolidation cycle (pre-dose, 1 and 4 hours post dose)|One question asking for description of leukemia symptoms.|Series of questions that ask for information that best describes health.|One question asking for information regarding leukemia symptoms.|Its the minimum trough concentration in plasma of glasdegib following multiple daily dosing to steady state.|It is the minimum trough concentration in plasma of glasdegib following multiple daily dosing to steady state.","5 years after last subject randomized, consent withdrawal, or death|2 years after last dose of study therapy|5 years after last patient randomized, withdrawal, or death|5 years after last subject randomized, withdrawal, or death|Day 10 of Induction Cycle and Day 1 of each Consolidation Cycle|Cycle 1 Day 15 and Cycles 2 and 3 on Day 1","ClinicalTrials.gov_Inquiries@pfizer.com","Pfizer CT.gov Call Center","1-800-718-1021","Nagoya, Aichi, Japan, 466-8650|Akita, Japan, 010-8543 Kyushu University HospitalFukuoka, Japan, 812-8582 Nagasaki University HospitalNagasaki, Japan, 852-8501 Tokyo Medical University HospitalTokyo, Japan, 160-0023 Korea, Republic Of, Jeollabuk-Do Chonbuk National University Hospital (Drug Shipment Only)Jeonju-Si, Jeollabuk-Do, Korea, Republic Of, 54907 Chonbuk National University HospitalJeonju-Si, Jeollabuk-Do, Korea, Republic Of, 54907 Korea, Republic Of Department Of Pharmacy, Inje University Busan Paik HospitalBusan, Korea, Republic Of, 47392 Inje University Busan Paik HospitalBusan, Korea, Republic Of, 47392 Clinical Trial Pharmacy, Keimyung University Dongsan HospitalDaegu, Korea, Republic Of, 41931 Keimyung University Dongsan HospitalDaegu, Korea, Republic Of, 41931 Seoul National University HospitalSeoul, Korea, Republic Of, 03080 Clinical Trial Center, Severance Hospital, Yonsei University Health System (Drug Shipment Only)Seoul, Korea, Republic Of, 03722 Severance Hospital, Yonsei University Health SystemSeoul, Korea, Republic Of, 03722 Department Of Pharmacy, Samsung Medical Center (Drug Shipment Only)Seoul, Korea, Republic Of, 06351 Samsung Medical CenterSeoul, Korea, Republic Of, 06351 Taiwan Department Of Clinical Trial Pharmacy, Taipei Veterans General HospitalTaipei, Taiwan, 11217 Taipei Veterans General HospitalTaipei, Taiwan, 11217|Yoshida-Gun, Fukui, Japan, 910-1193|Maebashi, Gunma, Japan, 371-8511|Kobe-Shi, Hyogo, Japan, 650-0017|Yokohama, Kanagawa, Japan, 232-0024|Sendai, Miyagi, Japan, 980-8574|Osaka-City, Osaka, Japan, 545-8586|Sunto-Gun, Shizuoka, Japan, 411-8777|Tachikawa, Tokyo, Japan, 190-0014|Lake Success, New York, United States, 11042 North Shore University HospitalManhasset, New York, United States, 11030 Long Island Jewish Medical CenterNew Hyde Park, New York, United States, 11040","New York","Japan|United States","Aichi Japanese Red Cross Nagoya Daini Hospital|Akita University Hospital|Fukui University Of Fukui Hospital|Gunma Gunma University Hospital|Hyogo Kobe University Hospital|Kanagawa Yokohama City University Medical Center|Miyagi Tohoku University Hospital|Osaka Osaka City University Hospital|Shizuoka Shizuoka Cancer Center|Tokyo National Hospital Organization Disaster Medical Center|Northwell Health Monter Cancer Center",{"$nulls":3},"Pfizer CT.gov Call Center","2018-05-25","2020-05-25T16:39:27.214","2020-05-26T17:10:42.972","NCT03416179"]
["5ecbf4bfe2561b1b11905eaa","NCT03416179","2018-07-03","Pfizer","PFE","Recruiting","A Study Evaluating Intensive Chemotherapy With or Without Glasdegib or Azacitidine With or Without Glasdegib In Patients With Previously Untreated Acute Myeloid Leukemia (BRIGHT AML1019)","Glasdegib|Cytarabine|Daunorubicin|Azacitidine","Hh Inhibitor|DNA Polymerase Inhibitor|Nucleic Acid Synthesis Inhibitor|TOP2 Inhibitor|DNA Mtase Inhibitor","Yes","['Glasdegib']","Unknown",null,"Phase 3",4,720,"Anticipated","2018-04-20","2023-02-16","OS","Overall Survival",{"$nulls":3},"Glasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).\n\nGlasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).","Two separate registration trials conducted under one protocol number are proposed to adequately and independently evaluate the addition of glasdegib in intensive and non-intensive chemotherapy populations. Each study will have an experimental treatment arm and a placebo arm. Endpoints are the same for each study except where specifically indicated.\n\nAssignment to the Intensive Study or the Non-Intensive Study will be made by the Investigator based on the 2017 European LeukemiaNet (ELN) recommendations.\n\nStudy B1371019 is a randomized (1:1), double-blind, multi-center, placebo controlled study of chemotherapy in combination with glasdegib versus chemotherapy in combination with placebo in adult patients with previously untreated AML.\n\nGlasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).\n\nGlasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).","A RANDOMIZED (1:1), DOUBLE-BLIND, MULTI-CENTER, PLACEBO CONTROLLED STUDY EVALUATING INTENSIVE CHEMOTHERAPY WITH OR WITHOUT GLASDEGIB (PF-04449913) OR AZACITIDINE (AZA) WITH OR WITHOUT GLASDEGIB IN PATIENTS WITH PREVIOUSLY UNTREATED ACUTE MYELOID LEUKEMIA","B1371019","Leukemia, Myeloid, Acute","Acute Leukemia|Acute Myeloid Leukemia|Myeloid Leukemia|Leukemia","Oncology Hematological","Oncology","Experimental|Placebo Comparator","Arm A (Intensive Study)|Arm B (Intensive Study)|Arm A (Non-intensive study)|Arm B (Non-intensive study)","Glasdegib + '7+3' Induction(s)|Placebo + '7+3' Induction(s)|Glasdegib + azacitidine|Placebo + azacitidine","Drug|Procedure","glasdegib|daunorubicin + cytarabine|cytarabine|HSCT|Placebo|azacitidine","Daily Glasdegib (100 mg, PO), beginning on Day 1 and is to continue up to 2 years post randomization.\n\nFollowing consolidation therapy, glasdegib or placebo will be administered daily for up to 2 years after randomization or until they have minimal residual disease (MRD) negative disease, whichever comes first.\n\nDaily Glasdegib (100 mg, PO) or matching placebo will continue throughout Induction(s) and Consolidation therapies regardless of dose modifications/delays in the chemotherapy.|Consolidation with single agent cytarabine 3 g/m2 IV for adults <60 years and 1 g/m2 for adults 60 years over 3 BID on Days 1, 3, and 5, every 28 days for up to 4 cycles or alternative single agent cytarabine consolidation schedules may be used per local prescribing information.|If required, and done per standard of care post Induction(s).|Azacitidine (75 mg/m2, SC or IV) daily for 7 days, in 28 day cycles for as long as they do not meet the criteria for disease progression, unacceptable toxicity, consent withdrawal, or death.|Matching placebo (PO) is to be administered by mouth daily beginning on Day 1 of chemotherapy and will continue if subjects demonstrate reasonable evidence of clinical benefit and do not meet the criteria for progression regardless of any delays/modifications in the chemotherapy treatment. Subjects will continue placebo until disease progression, unacceptable toxicity, consent withdrawal, or death, whichever comes first.","PF-04449913","Arm A (Intensive Study)|Arm B (Intensive Study)|Arm A (Non-intensive study)|Arm B (Non-intensive study)","\n\nSubjects must meet all of the following inclusion criteria to be eligible for enrollment into the Intensive and Non Intensive study (unless where indicated):\n\n 1.  Subjects with untreated AML according to the World Health Organization (WHO) 2016 Classification2, including those with: * AML arising from MDS or another antecedent hematologic disease (AHD).\n      * AML after previous cytotoxic therapy or radiation (secondary AML).\n     \n     \n 2.  18 years of age (In Japan, 20 years of age).\n 3.  Adequate Organ Function as defined by the following: * Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) 3 x upper limit of normal (ULN), excluding subjects with liver function abnormalities due to underlying malignancy.\n      * Total serum bilirubin 2 x ULN (except subjects with documented Gilbert's syndrome).\n      * Estimated creatinine clearance 30 mL/min as calculated using the standard method for the institution.\n     \n     \n 4.  QTc interval 470 msec using the Fridericia correction (QTcF).\n 5.  All anti cancer treatments (unless specified) should be discontinued 2 weeks from study entry, for example: targeted chemotherapy, radiotherapy, investigational agents, hormones, anagrelide or cytokines. * For control of rapidly progressing leukemia, all trans retinoic acid (ATRA), hydroxyurea, and/or leukopheresis may be used before and for up to 1 week after the first dose of glasdegib.\n     \n     \n 6.  Serum or urine pregnancy test (for female subjects of childbearing potential) with a minimum sensitivity of 25 IU/L or equivalent units of human chorionic gonadotropin (hCG) negative at screening.\n 7.  Male and female subjects of childbearing potential and at risk for pregnancy must agree to use at least one highly effective method of contraception throughout the study and for 180 days after the last dose of azacitidine, cytarabine, or daunorubicin; and the last dose of glasdegib or placebo, whichever occurs later.\n 8.  Female subjects of non childbearing potential must meet at least 1 of the following criteria: 1. Have undergone a documented hysterectomy and/or bilateral oophorectomy;\n      2. Have medically confirmed ovarian failure; or\n      3. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; status may be confirmed by having a serum follicle stimulating hormone (FSH) level confirming the postmenopausal state.\n     \n     All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential.\n     \n     \n 9.  Consent to a saliva sample collection for a germline comparator, unless prohibited by local regulations or ethics committee (EC) decision.\n 10. Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.\n 11. Subjects who are willing and able to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures (including bone marrow [BM] assessments).\n\n","\n\nSubjects with any of the following characteristics/conditions will not be included in the study:\n\n 1.  Acute Promyelocytic Leukemia (APL) and APLwith PML RARA, subjects (WHO 2016 classification).\n 2.  AML with BCR ABL1 or t(9;22)(q34;q11.2) as a sole abnormality. * Complex genetics may include t(9;22) cytogenetic translocation.\n     \n     \n 3.  Subjects with known active CNS leukemia.\n 4.  Participation in other clinical studies involving other investigational drug(s) (Phases 1 4) within 4 weeks prior study entry and/or during study participation.\n 5.  Subjects known to be refractory to platelet or packed red cell transfusions per Institutional Guidelines, or a patient who refuses blood product support.\n 6.  Subjects with another active malignancy on treatment with the exception of basal cell carcinoma, non melanoma skin cancer, cervical carcinoma in situ. Other prior or concurrent malignancies will be considered on a case by case basis.\n 7.  Any one of the following ongoing or in the previous 6 months: myocardial infarction, congenital long QT syndrome, Torsades de pointes, symptomatic arrhythmias (including sustained ventricular tachyarrhythmia), right or left bundle branch block and bifascicular block, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (CHF New York Heart Association class III or IV), cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism; as well as bradycardia defined as <50 bpms.\n 8.  Subjects with an active, life threatening or clinically significant uncontrolled systemic infection not related to AML.\n 9.  Subjects with left ventricular ejection fraction (LVEF) <50% are excluded from the Intensive Chemotherapy Study only.\n 10. Cumulative anthracycline dose equivalent of 550 mg/m2 of daunorubicin for the Intensive Chemotherapy Study only.\n 11. Known malabsorption syndrome or other condition that may significantly impair absorption of study medication in the investigator's judgment (eg, gastrectomy, lap band, Crohn's disease) and inability or unwillingness to swallow tablets or capsules.\n 12. Current use or anticipated requirement for drugs that are known strong CYP3A4/5 inducers.\n 13. Concurrent administration of herbal preparations.\n 14. Major surgery or radiation within 4 weeks of starting study treatment.\n 15. Documented or suspected hypersensitivity to any one of the following: * For subjects assigned to intensive chemotherapy, documented or suspected hypersensitivity to cytarabine (not including drug fever or exanthema, including known cerebellar side effects) or daunorubicin.\n      * For subjects assigned to non intensive chemotherapy, documented or suspected hypersensitivity to azacitidine or mannitol.\n     \n     \n 16. Known active drug or alcohol abuse.\n 17. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.\n 18. Pregnant females or breastfeeding female subjects.\n 19. Known recent or active suicidal ideation or behavior.\n 20. Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.","FSH",null,"Protein","Ovary","Actual","2018-01-31","Actual","Anticipated","2025-07-22","Anticipated","2018-06-01","2017-12-21","2018-01-23","2018-06-29","Yes","glasdegib;\nuntreated;\nHedgehog Inhibitor","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"All",null,"No","Yes\nInformation relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests",null,"URL: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1371019&StudyName=A+Randomized+%281%3A1%29%2C+Double+Blind%2C+Multi+Center%2C+Placebo+Controlled+Study+Evaluating+Intensive+Chemotherapy+With+Or+Without+Glasdegib+%28pf+04449913%29+Or+Azacitidine+%28aza%29+With+Or+Without+Glasdegib+In+Patients+With+Previously+Untreated+Acute+Myeloid+Leukemia [https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1371019&StudyName=A+Randomized+%281%3A1%29%2C+Double+Blind%2C+Multi+Center%2C+Placebo+Controlled+Study+Evaluating+Intensive+Chemotherapy+With+Or+Without+Glasdegib+%28pf+04449913%29+Or+Azacitidine+%28aza%29+With+Or+Without+Glasdegib+In+Patients+With+Previously+Untreated+Acute+Myeloid+Leukemia] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To obtain contact information for a study center near you, click here.",null,"Yes","No",{"$nulls":17},"2017-002822-19|BRIGHT|BRIGHT AML1019","EudraCT Number|Alias Study Number","Overall survival","5 years after last subject randomized",null,"Fatigue score measured by the MD Anderson Symptom Inventory (MDASI)-AML/MDS questionnaire|Rate of Complete Remission (CR) (including CR with minimal residual disease (MRD)-negative as assessed by multiparametric flow cytometry)|Duration of response (defined as CR [includes CR-MRD negative]/CRi or CR/CRh as appropriate)|Time to response (CR[includes CR-MRD negative)]/CR with partial hematologic rcovery (CRh) as appropriate)|Event-free Survival|Patient Reported Outcomes (PROs) as measured by the M.D. Anderson Symptom Inventory AML/MDS Module (MDASI-AML/MDS)|Adverse events as graded by NCI CTCAE v4.03|Laboratory abnormalities as graded by NCI CTCAE v4.03|For the intensive study, the plasma trough concentration (Ctrough) will be analyzed|QTc interval|PROs as measured by Patient Global Impression of Change (PGIC)|Patient Reported Outcomes (PROs) as measured by EuroQoL 5 Dimension questionnaire 5-Level version (EQ-5D-5L)|Patient Reported Outcomes (PROs) as measured by Patient Global Impression of Symptoms (PGIS)|Complete Remission with incomplete hematologic recovery (CRi)|Rate of morphological leukemia-free state (MLFS)|Rate of Partial Remission (PR)|Rate of Complete Remission with partial hematological recovery (CRh) for the Non-intensive study only only|Minimum Observed Plasma Trough Concentratrion of glasdegib in the Intensive Study|Minimum Observed Plasma Trough Concentration of glasdegib in the Non-intensive study","Scale is from 0-10 where 0 is not present and 10 is as bad as you can image.|Response as defined by the 2017 European LeukemiaNet (ELN) recommendations.|5 years after last subject randomized, consent withdrawal, or death|Measurement Scale from 0-10.|PK samples taken on Induction(s) Day 1 (1 and 4 hours post induction); Induction(s) Day 10 (pre-dose, 1 and 4 hours post dose); Day 1 of each Consolidation cycle (pre-dose, 1 and 4 hours post dose)|One question asking for description of leukemia symptoms.|Series of questions that ask for information that best describes health.|One question asking for information regarding leukemia symptoms.|Its the minimum trough concentration in plasma of glasdegib following multiple daily dosing to steady state.|It is the minimum trough concentration in plasma of glasdegib following multiple daily dosing to steady state.","5 years after last subject randomized, consent withdrawal, or death|2 years after last dose of study therapy|5 years after last patient randomized, withdrawal, or death|5 years after last subject randomized, withdrawal, or death|Day 10 of Induction Cycle and Day 1 of each Consolidation Cycle|Cycle 1 Day 15 and Cycles 2 and 3 on Day 1","ClinicalTrials.gov_Inquiries@pfizer.com","Pfizer CT.gov Call Center","1-800-718-1021","Nagoya, Aichi, Japan, 466-8650|Akita, Japan, 010-8543 Kyushu University HospitalFukuoka, Japan, 812-8582 National Hospital Organization Kumamoto Medical CenterKumamoto, Japan, 860-0008 Nagasaki University HospitalNagasaki, Japan, 852-8501 Tokyo Medical University HospitalTokyo, Japan, 160-0023 Korea, Republic Of, Jeollabuk-Do Chonbuk National University Hospital (Drug Shipment Only)Jeonju-Si, Jeollabuk-Do, Korea, Republic Of, 54907 Chonbuk National University HospitalJeonju-Si, Jeollabuk-Do, Korea, Republic Of, 54907 Korea, Republic Of, Jeollanam-Do Chonnam National University Hwasun HospitalHwasun-Gun, Jeollanam-Do, Korea, Republic Of, 58128 Korea, Republic Of Department Of Pharmacy, Inje University Busan Paik HospitalBusan, Korea, Republic Of, 47392 Inje University Busan Paik HospitalBusan, Korea, Republic Of, 47392 Clinical Trial Pharmacy, Keimyung University Dongsan HospitalDaegu, Korea, Republic Of, 41931 Keimyung University Dongsan HospitalDaegu, Korea, Republic Of, 41931 Gachon University Gil Medical CenterIncheon, Korea, Republic Of, 21565 Seoul National University HospitalSeoul, Korea, Republic Of, 03080 Clinical Trial Center, Severance Hospital, Yonsei University Health System (Drug Shipment Only)Seoul, Korea, Republic Of, 03722 Severance Hospital, Yonsei University Health SystemSeoul, Korea, Republic Of, 03722 Department Of Pharmacy, Samsung Medical Center (Drug Shipment Only)Seoul, Korea, Republic Of, 06351 Samsung Medical CenterSeoul, Korea, Republic Of, 06351 The Catholic University Of Korea Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591 The Catholic University Of KoreaSeoul, Korea, Republic Of, 06591 Taiwan Department Of Clinical Trial Pharmacy, Taipei Veterans General HospitalTaipei, Taiwan, 11217 Taipei Veterans General HospitalTaipei, Taiwan, 11217 Chang Gung Memorial Hospital-Linkou BranchTaoyuan City, Taiwan, 333 Chemotherapy Pharmacy, Chang Gung Memorial Hospital-Linkou BranchTaoyuan City, Taiwan, 333|Yoshida-Gun, Fukui, Japan, 910-1193|Maebashi, Gunma, Japan, 371-8511|Kobe-Shi, Hyogo, Japan, 650-0017|Yokohama, Kanagawa, Japan, 232-0024|Sendai, Miyagi, Japan, 980-8574|Osaka-City, Osaka, Japan, 545-8586 Kindai University HospitalOsaka-Sayama, Osaka, Japan, 589-8511|Sunto-Gun, Shizuoka, Japan, 411-8777|Tachikawa, Tokyo, Japan, 190-0014|Orange, California, United States, 92868-3201 Uc Irvine Medical CenterOrange, California, United States, 92868-3201|Lake Success, New York, United States, 11042 North Shore University HospitalManhasset, New York, United States, 11030 Long Island Jewish Medical CenterNew Hyde Park, New York, United States, 11040","California|New York","Japan|United States","Aichi Japanese Red Cross Nagoya Daini Hospital|Akita University Hospital|Fukui University Of Fukui Hospital|Gunma Gunma University Hospital|Hyogo Kobe University Hospital|Kanagawa Yokohama City University Medical Center|Miyagi Tohoku University Hospital|Osaka Osaka City University Hospital|Shizuoka Shizuoka Cancer Center|Tokyo National Hospital Organization Disaster Medical Center|Uc Irvine Health - Chao Family Comprehensive Cancer Center|Northwell Health Monter Cancer Center",{"$nulls":3},"Pfizer CT.gov Call Center","2018-06-29","2020-05-25T16:39:27.719","2020-05-26T17:10:42.972","NCT03416179"]
["5ecbf4bf307e3d1b1f8d9e42","NCT03416179","2018-07-11","Pfizer","PFE","Recruiting","A Study Evaluating Intensive Chemotherapy With or Without Glasdegib or Azacitidine With or Without Glasdegib In Patients With Previously Untreated Acute Myeloid Leukemia (BRIGHT AML1019)","Glasdegib|Cytarabine|Daunorubicin|Azacitidine","Hh Inhibitor|DNA Polymerase Inhibitor|Nucleic Acid Synthesis Inhibitor|TOP2 Inhibitor|DNA Mtase Inhibitor","Yes","['Glasdegib']","Unknown",null,"Phase 3",4,720,"Anticipated","2018-04-20","2023-02-16","OS","Overall Survival",{"$nulls":3},"Glasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).\n\nGlasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).","Two separate registration trials conducted under one protocol number are proposed to adequately and independently evaluate the addition of glasdegib in intensive and non-intensive chemotherapy populations. Each study will have an experimental treatment arm and a placebo arm. Endpoints are the same for each study except where specifically indicated.\n\nAssignment to the Intensive Study or the Non-Intensive Study will be made by the Investigator based on the 2017 European LeukemiaNet (ELN) recommendations.\n\nStudy B1371019 is a randomized (1:1), double-blind, multi-center, placebo controlled study of chemotherapy in combination with glasdegib versus chemotherapy in combination with placebo in adult patients with previously untreated AML.\n\nGlasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).\n\nGlasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).","A RANDOMIZED (1:1), DOUBLE-BLIND, MULTI-CENTER, PLACEBO CONTROLLED STUDY EVALUATING INTENSIVE CHEMOTHERAPY WITH OR WITHOUT GLASDEGIB (PF-04449913) OR AZACITIDINE (AZA) WITH OR WITHOUT GLASDEGIB IN PATIENTS WITH PREVIOUSLY UNTREATED ACUTE MYELOID LEUKEMIA","B1371019","Leukemia, Myeloid, Acute","Acute Leukemia|Acute Myeloid Leukemia|Myeloid Leukemia|Leukemia","Oncology Hematological","Oncology","Experimental|Placebo Comparator","Arm A (Intensive Study)|Arm B (Intensive Study)|Arm A (Non-intensive study)|Arm B (Non-intensive study)","Glasdegib + '7+3' Induction(s)|Placebo + '7+3' Induction(s)|Glasdegib + azacitidine|Placebo + azacitidine","Drug|Procedure","glasdegib|daunorubicin + cytarabine|cytarabine|HSCT|Placebo|azacitidine","Daily Glasdegib (100 mg, PO), beginning on Day 1 and is to continue up to 2 years post randomization.\n\nFollowing consolidation therapy, glasdegib or placebo will be administered daily for up to 2 years after randomization or until they have minimal residual disease (MRD) negative disease, whichever comes first.\n\nDaily Glasdegib (100 mg, PO) or matching placebo will continue throughout Induction(s) and Consolidation therapies regardless of dose modifications/delays in the chemotherapy.|Consolidation with single agent cytarabine 3 g/m2 IV for adults <60 years and 1 g/m2 for adults 60 years over 3 BID on Days 1, 3, and 5, every 28 days for up to 4 cycles or alternative single agent cytarabine consolidation schedules may be used per local prescribing information.|If required, and done per standard of care post Induction(s).|Azacitidine (75 mg/m2, SC or IV) daily for 7 days, in 28 day cycles for as long as they do not meet the criteria for disease progression, unacceptable toxicity, consent withdrawal, or death.|Matching placebo (PO) is to be administered by mouth daily beginning on Day 1 of chemotherapy and will continue if subjects demonstrate reasonable evidence of clinical benefit and do not meet the criteria for progression regardless of any delays/modifications in the chemotherapy treatment. Subjects will continue placebo until disease progression, unacceptable toxicity, consent withdrawal, or death, whichever comes first.","PF-04449913","Arm A (Intensive Study)|Arm B (Intensive Study)|Arm A (Non-intensive study)|Arm B (Non-intensive study)","\n\nSubjects must meet all of the following inclusion criteria to be eligible for enrollment into the Intensive and Non Intensive study (unless where indicated):\n\n 1.  Subjects with untreated AML according to the World Health Organization (WHO) 2016 Classification2, including those with: * AML arising from MDS or another antecedent hematologic disease (AHD).\n      * AML after previous cytotoxic therapy or radiation (secondary AML).\n     \n     \n 2.  18 years of age (In Japan, 20 years of age).\n 3.  Adequate Organ Function as defined by the following: * Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) 3 x upper limit of normal (ULN), excluding subjects with liver function abnormalities due to underlying malignancy.\n      * Total serum bilirubin 2 x ULN (except subjects with documented Gilbert's syndrome).\n      * Estimated creatinine clearance 30 mL/min as calculated using the standard method for the institution.\n     \n     \n 4.  QTc interval 470 msec using the Fridericia correction (QTcF).\n 5.  All anti cancer treatments (unless specified) should be discontinued 2 weeks from study entry, for example: targeted chemotherapy, radiotherapy, investigational agents, hormones, anagrelide or cytokines. * For control of rapidly progressing leukemia, all trans retinoic acid (ATRA), hydroxyurea, and/or leukopheresis may be used before and for up to 1 week after the first dose of glasdegib.\n     \n     \n 6.  Serum or urine pregnancy test (for female subjects of childbearing potential) with a minimum sensitivity of 25 IU/L or equivalent units of human chorionic gonadotropin (hCG) negative at screening.\n 7.  Male and female subjects of childbearing potential and at risk for pregnancy must agree to use at least one highly effective method of contraception throughout the study and for 180 days after the last dose of azacitidine, cytarabine, or daunorubicin; and the last dose of glasdegib or placebo, whichever occurs later.\n 8.  Female subjects of non childbearing potential must meet at least 1 of the following criteria: 1. Have undergone a documented hysterectomy and/or bilateral oophorectomy;\n      2. Have medically confirmed ovarian failure; or\n      3. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; status may be confirmed by having a serum follicle stimulating hormone (FSH) level confirming the postmenopausal state.\n     \n     All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential.\n     \n     \n 9.  Consent to a saliva sample collection for a germline comparator, unless prohibited by local regulations or ethics committee (EC) decision.\n 10. Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.\n 11. Subjects who are willing and able to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures (including bone marrow [BM] assessments).\n\n","\n\nSubjects with any of the following characteristics/conditions will not be included in the study:\n\n 1.  Acute Promyelocytic Leukemia (APL) and APLwith PML RARA, subjects (WHO 2016 classification).\n 2.  AML with BCR ABL1 or t(9;22)(q34;q11.2) as a sole abnormality. * Complex genetics may include t(9;22) cytogenetic translocation.\n     \n     \n 3.  Subjects with known active CNS leukemia.\n 4.  Participation in other clinical studies involving other investigational drug(s) (Phases 1 4) within 4 weeks prior study entry and/or during study participation.\n 5.  Subjects known to be refractory to platelet or packed red cell transfusions per Institutional Guidelines, or a patient who refuses blood product support.\n 6.  Subjects with another active malignancy on treatment with the exception of basal cell carcinoma, non melanoma skin cancer, cervical carcinoma in situ. Other prior or concurrent malignancies will be considered on a case by case basis.\n 7.  Any one of the following ongoing or in the previous 6 months: myocardial infarction, congenital long QT syndrome, Torsades de pointes, symptomatic arrhythmias (including sustained ventricular tachyarrhythmia), right or left bundle branch block and bifascicular block, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (CHF New York Heart Association class III or IV), cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism; as well as bradycardia defined as <50 bpms.\n 8.  Subjects with an active, life threatening or clinically significant uncontrolled systemic infection not related to AML.\n 9.  Subjects with left ventricular ejection fraction (LVEF) <50% are excluded from the Intensive Chemotherapy Study only.\n 10. Cumulative anthracycline dose equivalent of 550 mg/m2 of daunorubicin for the Intensive Chemotherapy Study only.\n 11. Known malabsorption syndrome or other condition that may significantly impair absorption of study medication in the investigator's judgment (eg, gastrectomy, lap band, Crohn's disease) and inability or unwillingness to swallow tablets or capsules.\n 12. Current use or anticipated requirement for drugs that are known strong CYP3A4/5 inducers.\n 13. Concurrent administration of herbal preparations.\n 14. Major surgery or radiation within 4 weeks of starting study treatment.\n 15. Documented or suspected hypersensitivity to any one of the following: * For subjects assigned to intensive chemotherapy, documented or suspected hypersensitivity to cytarabine (not including drug fever or exanthema, including known cerebellar side effects) or daunorubicin.\n      * For subjects assigned to non intensive chemotherapy, documented or suspected hypersensitivity to azacitidine or mannitol.\n     \n     \n 16. Known active drug or alcohol abuse.\n 17. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.\n 18. Pregnant females or breastfeeding female subjects.\n 19. Known recent or active suicidal ideation or behavior.\n 20. Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.","FSH",null,"Protein","Ovary","Actual","2018-01-31","Actual","Anticipated","2025-07-22","Anticipated","2018-07-01","2017-12-21","2018-01-23","2018-07-09","Yes","glasdegib;\nuntreated;\nHedgehog Inhibitor","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"All",null,"No","Yes\nInformation relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests",null,"URL: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1371019&StudyName=A+Randomized+%281%3A1%29%2C+Double+Blind%2C+Multi+Center%2C+Placebo+Controlled+Study+Evaluating+Intensive+Chemotherapy+With+Or+Without+Glasdegib+%28pf+04449913%29+Or+Azacitidine+%28aza%29+With+Or+Without+Glasdegib+In+Patients+With+Previously+Untreated+Acute+Myeloid+Leukemia [https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1371019&StudyName=A+Randomized+%281%3A1%29%2C+Double+Blind%2C+Multi+Center%2C+Placebo+Controlled+Study+Evaluating+Intensive+Chemotherapy+With+Or+Without+Glasdegib+%28pf+04449913%29+Or+Azacitidine+%28aza%29+With+Or+Without+Glasdegib+In+Patients+With+Previously+Untreated+Acute+Myeloid+Leukemia] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To obtain contact information for a study center near you, click here.",null,"Yes","No",{"$nulls":17},"2017-002822-19|BRIGHT|BRIGHT AML1019","EudraCT Number|Alias Study Number","Overall survival","5 years after last subject randomized",null,"Fatigue score measured by the MD Anderson Symptom Inventory (MDASI)-AML/MDS questionnaire|Rate of Complete Remission (CR) (including CR with minimal residual disease (MRD)-negative as assessed by multiparametric flow cytometry)|Duration of response (defined as CR [includes CR-MRD negative]/CRi or CR/CRh as appropriate)|Time to response (CR[includes CR-MRD negative)]/CR with partial hematologic rcovery (CRh) as appropriate)|Event-free Survival|Patient Reported Outcomes (PROs) as measured by the M.D. Anderson Symptom Inventory AML/MDS Module (MDASI-AML/MDS)|Adverse events as graded by NCI CTCAE v4.03|Laboratory abnormalities as graded by NCI CTCAE v4.03|For the intensive study, the plasma trough concentration (Ctrough) will be analyzed|QTc interval|PROs as measured by Patient Global Impression of Change (PGIC)|Patient Reported Outcomes (PROs) as measured by EuroQoL 5 Dimension questionnaire 5-Level version (EQ-5D-5L)|Patient Reported Outcomes (PROs) as measured by Patient Global Impression of Symptoms (PGIS)|Complete Remission with incomplete hematologic recovery (CRi)|Rate of morphological leukemia-free state (MLFS)|Rate of Partial Remission (PR)|Rate of Complete Remission with partial hematological recovery (CRh) for the Non-intensive study only only|Minimum Observed Plasma Trough Concentratrion of glasdegib in the Intensive Study|Minimum Observed Plasma Trough Concentration of glasdegib in the Non-intensive study","Scale is from 0-10 where 0 is not present and 10 is as bad as you can image.|Response as defined by the 2017 European LeukemiaNet (ELN) recommendations.|5 years after last subject randomized, consent withdrawal, or death|Measurement Scale from 0-10.|PK samples taken on Induction(s) Day 1 (1 and 4 hours post induction); Induction(s) Day 10 (pre-dose, 1 and 4 hours post dose); Day 1 of each Consolidation cycle (pre-dose, 1 and 4 hours post dose)|One question asking for description of leukemia symptoms.|Series of questions that ask for information that best describes health.|One question asking for information regarding leukemia symptoms.|Its the minimum trough concentration in plasma of glasdegib following multiple daily dosing to steady state.|It is the minimum trough concentration in plasma of glasdegib following multiple daily dosing to steady state.","5 years after last subject randomized, consent withdrawal, or death|2 years after last dose of study therapy|5 years after last patient randomized, withdrawal, or death|5 years after last subject randomized, withdrawal, or death|Day 10 of Induction Cycle and Day 1 of each Consolidation Cycle|Cycle 1 Day 15 and Cycles 2 and 3 on Day 1","ClinicalTrials.gov_Inquiries@pfizer.com","Pfizer CT.gov Call Center","1-800-718-1021","Nagoya, Aichi, Japan, 466-8650|Akita, Japan, 010-8543 Kyushu University HospitalFukuoka, Japan, 812-8582 National Hospital Organization Kumamoto Medical CenterKumamoto, Japan, 860-0008 Nagasaki University HospitalNagasaki, Japan, 852-8501 Tokyo Medical University HospitalTokyo, Japan, 160-0023 Korea, Republic Of, Jeollabuk-Do Chonbuk National University Hospital (Drug Shipment Only)Jeonju-Si, Jeollabuk-Do, Korea, Republic Of, 54907 Chonbuk National University HospitalJeonju-Si, Jeollabuk-Do, Korea, Republic Of, 54907 Korea, Republic Of, Jeollanam-Do Chonnam National University Hwasun HospitalHwasun-Gun, Jeollanam-Do, Korea, Republic Of, 58128 Korea, Republic Of Department Of Pharmacy, Inje University Busan Paik HospitalBusan, Korea, Republic Of, 47392 Inje University Busan Paik HospitalBusan, Korea, Republic Of, 47392 Clinical Trial Pharmacy, Keimyung University Dongsan HospitalDaegu, Korea, Republic Of, 41931 Keimyung University Dongsan HospitalDaegu, Korea, Republic Of, 41931 Gachon University Gil Medical CenterIncheon, Korea, Republic Of, 21565 Seoul National University HospitalSeoul, Korea, Republic Of, 03080 Clinical Trial Center, Severance Hospital, Yonsei University Health System (Drug Shipment Only)Seoul, Korea, Republic Of, 03722 Severance Hospital, Yonsei University Health SystemSeoul, Korea, Republic Of, 03722 Department Of Pharmacy, Samsung Medical Center (Drug Shipment Only)Seoul, Korea, Republic Of, 06351 Samsung Medical CenterSeoul, Korea, Republic Of, 06351 The Catholic University Of Korea Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591 The Catholic University Of KoreaSeoul, Korea, Republic Of, 06591 Russian Federation State Budgetary Institution Of Ryazan Region 'Regional Clinical Hospital' (Sbi Rr Rch)Ryazan, Russian Federation, 390039 Taiwan Department Of Clinical Trial Pharmacy, Taipei Veterans General HospitalTaipei, Taiwan, 11217 Taipei Veterans General HospitalTaipei, Taiwan, 11217 Chang Gung Memorial Hospital-Linkou BranchTaoyuan City, Taiwan, 333 Chemotherapy Pharmacy, Chang Gung Memorial Hospital-Linkou BranchTaoyuan City, Taiwan, 333|Yoshida-Gun, Fukui, Japan, 910-1193|Maebashi, Gunma, Japan, 371-8511|Kobe-Shi, Hyogo, Japan, 650-0017|Yokohama, Kanagawa, Japan, 232-0024|Sendai, Miyagi, Japan, 980-8574|Osaka-City, Osaka, Japan, 545-8586 Kindai University HospitalOsaka-Sayama, Osaka, Japan, 589-8511|Sunto-Gun, Shizuoka, Japan, 411-8777|Tachikawa, Tokyo, Japan, 190-0014|Orange, California, United States, 92868-3201 Uc Irvine Medical CenterOrange, California, United States, 92868-3201|Lake Success, New York, United States, 11042 North Shore University HospitalManhasset, New York, United States, 11030 Long Island Jewish Medical CenterNew Hyde Park, New York, United States, 11040","California|New York","Japan|United States","Aichi Japanese Red Cross Nagoya Daini Hospital|Akita University Hospital|Fukui University Of Fukui Hospital|Gunma Gunma University Hospital|Hyogo Kobe University Hospital|Kanagawa Yokohama City University Medical Center|Miyagi Tohoku University Hospital|Osaka Osaka City University Hospital|Shizuoka Shizuoka Cancer Center|Tokyo National Hospital Organization Disaster Medical Center|Uc Irvine Health - Chao Family Comprehensive Cancer Center|Northwell Health Monter Cancer Center",{"$nulls":3},"Pfizer CT.gov Call Center","2018-07-09","2020-05-25T16:39:27.833","2020-05-26T17:10:42.972","NCT03416179"]
["5ecbf4bffe30261b1a0483b1","NCT03416179","2018-07-17","Pfizer","PFE","Recruiting","A Study Evaluating Intensive Chemotherapy With or Without Glasdegib or Azacitidine With or Without Glasdegib In Patients With Previously Untreated Acute Myeloid Leukemia (BRIGHT AML1019)","Glasdegib|Cytarabine|Daunorubicin|Azacitidine","Hh Inhibitor|DNA Polymerase Inhibitor|Nucleic Acid Synthesis Inhibitor|TOP2 Inhibitor|DNA Mtase Inhibitor","Yes","['Glasdegib']","Unknown",null,"Phase 3",4,720,"Anticipated","2018-04-20","2023-02-16","OS","Overall Survival",{"$nulls":3},"Glasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).\n\nGlasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).","Two separate registration trials conducted under one protocol number are proposed to adequately and independently evaluate the addition of glasdegib in intensive and non-intensive chemotherapy populations. Each study will have an experimental treatment arm and a placebo arm. Endpoints are the same for each study except where specifically indicated.\n\nAssignment to the Intensive Study or the Non-Intensive Study will be made by the Investigator based on the 2017 European LeukemiaNet (ELN) recommendations.\n\nStudy B1371019 is a randomized (1:1), double-blind, multi-center, placebo controlled study of chemotherapy in combination with glasdegib versus chemotherapy in combination with placebo in adult patients with previously untreated AML.\n\nGlasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).\n\nGlasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).","A RANDOMIZED (1:1), DOUBLE-BLIND, MULTI-CENTER, PLACEBO CONTROLLED STUDY EVALUATING INTENSIVE CHEMOTHERAPY WITH OR WITHOUT GLASDEGIB (PF-04449913) OR AZACITIDINE (AZA) WITH OR WITHOUT GLASDEGIB IN PATIENTS WITH PREVIOUSLY UNTREATED ACUTE MYELOID LEUKEMIA","B1371019","Leukemia, Myeloid, Acute","Acute Leukemia|Acute Myeloid Leukemia|Myeloid Leukemia|Leukemia","Oncology Hematological","Oncology","Experimental|Placebo Comparator","Arm A (Intensive Study)|Arm B (Intensive Study)|Arm A (Non-intensive study)|Arm B (Non-intensive study)","Glasdegib + '7+3' Induction(s)|Placebo + '7+3' Induction(s)|Glasdegib + azacitidine|Placebo + azacitidine","Drug|Procedure","glasdegib|daunorubicin + cytarabine|cytarabine|HSCT|Placebo|azacitidine","Daily Glasdegib (100 mg, PO), beginning on Day 1 and is to continue up to 2 years post randomization.\n\nFollowing consolidation therapy, glasdegib or placebo will be administered daily for up to 2 years after randomization or until they have minimal residual disease (MRD) negative disease, whichever comes first.\n\nDaily Glasdegib (100 mg, PO) or matching placebo will continue throughout Induction(s) and Consolidation therapies regardless of dose modifications/delays in the chemotherapy.|Consolidation with single agent cytarabine 3 g/m2 IV for adults <60 years and 1 g/m2 for adults 60 years over 3 BID on Days 1, 3, and 5, every 28 days for up to 4 cycles or alternative single agent cytarabine consolidation schedules may be used per local prescribing information.|If required, and done per standard of care post Induction(s).|Azacitidine (75 mg/m2, SC or IV) daily for 7 days, in 28 day cycles for as long as they do not meet the criteria for disease progression, unacceptable toxicity, consent withdrawal, or death.|Matching placebo (PO) is to be administered by mouth daily beginning on Day 1 of chemotherapy and will continue if subjects demonstrate reasonable evidence of clinical benefit and do not meet the criteria for progression regardless of any delays/modifications in the chemotherapy treatment. Subjects will continue placebo until disease progression, unacceptable toxicity, consent withdrawal, or death, whichever comes first.","PF-04449913","Arm A (Intensive Study)|Arm B (Intensive Study)|Arm A (Non-intensive study)|Arm B (Non-intensive study)","\n\nSubjects must meet all of the following inclusion criteria to be eligible for enrollment into the Intensive and Non Intensive study (unless where indicated):\n\n 1.  Subjects with untreated AML according to the World Health Organization (WHO) 2016 Classification2, including those with: * AML arising from MDS or another antecedent hematologic disease (AHD).\n      * AML after previous cytotoxic therapy or radiation (secondary AML).\n     \n     \n 2.  18 years of age (In Japan, 20 years of age).\n 3.  Adequate Organ Function as defined by the following: * Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) 3 x upper limit of normal (ULN), excluding subjects with liver function abnormalities due to underlying malignancy.\n      * Total serum bilirubin 2 x ULN (except subjects with documented Gilbert's syndrome).\n      * Estimated creatinine clearance 30 mL/min as calculated using the standard method for the institution.\n     \n     \n 4.  QTc interval 470 msec using the Fridericia correction (QTcF).\n 5.  All anti cancer treatments (unless specified) should be discontinued 2 weeks from study entry, for example: targeted chemotherapy, radiotherapy, investigational agents, hormones, anagrelide or cytokines. * For control of rapidly progressing leukemia, all trans retinoic acid (ATRA), hydroxyurea, and/or leukopheresis may be used before and for up to 1 week after the first dose of glasdegib.\n     \n     \n 6.  Serum or urine pregnancy test (for female subjects of childbearing potential) with a minimum sensitivity of 25 IU/L or equivalent units of human chorionic gonadotropin (hCG) negative at screening.\n 7.  Male and female subjects of childbearing potential and at risk for pregnancy must agree to use at least one highly effective method of contraception throughout the study and for 180 days after the last dose of azacitidine, cytarabine, or daunorubicin; and the last dose of glasdegib or placebo, whichever occurs later.\n 8.  Female subjects of non childbearing potential must meet at least 1 of the following criteria: 1. Have undergone a documented hysterectomy and/or bilateral oophorectomy;\n      2. Have medically confirmed ovarian failure; or\n      3. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; status may be confirmed by having a serum follicle stimulating hormone (FSH) level confirming the postmenopausal state.\n     \n     All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential.\n     \n     \n 9.  Consent to a saliva sample collection for a germline comparator, unless prohibited by local regulations or ethics committee (EC) decision.\n 10. Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.\n 11. Subjects who are willing and able to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures (including bone marrow [BM] assessments).\n\n","\n\nSubjects with any of the following characteristics/conditions will not be included in the study:\n\n 1.  Acute Promyelocytic Leukemia (APL) and APLwith PML RARA, subjects (WHO 2016 classification).\n 2.  AML with BCR ABL1 or t(9;22)(q34;q11.2) as a sole abnormality. * Complex genetics may include t(9;22) cytogenetic translocation.\n     \n     \n 3.  Subjects with known active CNS leukemia.\n 4.  Participation in other clinical studies involving other investigational drug(s) (Phases 1 4) within 4 weeks prior study entry and/or during study participation.\n 5.  Subjects known to be refractory to platelet or packed red cell transfusions per Institutional Guidelines, or a patient who refuses blood product support.\n 6.  Subjects with another active malignancy on treatment with the exception of basal cell carcinoma, non melanoma skin cancer, cervical carcinoma in situ. Other prior or concurrent malignancies will be considered on a case by case basis.\n 7.  Any one of the following ongoing or in the previous 6 months: myocardial infarction, congenital long QT syndrome, Torsades de pointes, symptomatic arrhythmias (including sustained ventricular tachyarrhythmia), right or left bundle branch block and bifascicular block, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (CHF New York Heart Association class III or IV), cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism; as well as bradycardia defined as <50 bpms.\n 8.  Subjects with an active, life threatening or clinically significant uncontrolled systemic infection not related to AML.\n 9.  Subjects with left ventricular ejection fraction (LVEF) <50% are excluded from the Intensive Chemotherapy Study only.\n 10. Cumulative anthracycline dose equivalent of 550 mg/m2 of daunorubicin for the Intensive Chemotherapy Study only.\n 11. Known malabsorption syndrome or other condition that may significantly impair absorption of study medication in the investigator's judgment (eg, gastrectomy, lap band, Crohn's disease) and inability or unwillingness to swallow tablets or capsules.\n 12. Current use or anticipated requirement for drugs that are known strong CYP3A4/5 inducers.\n 13. Concurrent administration of herbal preparations.\n 14. Major surgery or radiation within 4 weeks of starting study treatment.\n 15. Documented or suspected hypersensitivity to any one of the following: * For subjects assigned to intensive chemotherapy, documented or suspected hypersensitivity to cytarabine (not including drug fever or exanthema, including known cerebellar side effects) or daunorubicin.\n      * For subjects assigned to non intensive chemotherapy, documented or suspected hypersensitivity to azacitidine or mannitol.\n     \n     \n 16. Known active drug or alcohol abuse.\n 17. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.\n 18. Pregnant females or breastfeeding female subjects.\n 19. Known recent or active suicidal ideation or behavior.\n 20. Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.","FSH",null,"Protein","Ovary","Actual","2018-01-31","Actual","Anticipated","2025-07-22","Anticipated","2018-07-01","2017-12-21","2018-01-23","2018-07-14","Yes","glasdegib;\nuntreated;\nHedgehog Inhibitor","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"All",null,"No","Yes\nInformation relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests",null,"URL: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1371019&StudyName=A+Randomized+%281%3A1%29%2C+Double+Blind%2C+Multi+Center%2C+Placebo+Controlled+Study+Evaluating+Intensive+Chemotherapy+With+Or+Without+Glasdegib+%28pf+04449913%29+Or+Azacitidine+%28aza%29+With+Or+Without+Glasdegib+In+Patients+With+Previously+Untreated+Acute+Myeloid+Leukemia [https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1371019&StudyName=A+Randomized+%281%3A1%29%2C+Double+Blind%2C+Multi+Center%2C+Placebo+Controlled+Study+Evaluating+Intensive+Chemotherapy+With+Or+Without+Glasdegib+%28pf+04449913%29+Or+Azacitidine+%28aza%29+With+Or+Without+Glasdegib+In+Patients+With+Previously+Untreated+Acute+Myeloid+Leukemia] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To obtain contact information for a study center near you, click here.",null,"Yes","No",{"$nulls":17},"2017-002822-19|BRIGHT|BRIGHT AML1019","EudraCT Number|Alias Study Number","Overall survival","5 years after last subject randomized",null,"Fatigue score measured by the MD Anderson Symptom Inventory (MDASI)-AML/MDS questionnaire|Rate of Complete Remission (CR) (including CR with minimal residual disease (MRD)-negative as assessed by multiparametric flow cytometry)|Duration of response (defined as CR [includes CR-MRD negative]/CRi or CR/CRh as appropriate)|Time to response (CR[includes CR-MRD negative)]/CR with partial hematologic rcovery (CRh) as appropriate)|Event-free Survival|Patient Reported Outcomes (PROs) as measured by the M.D. Anderson Symptom Inventory AML/MDS Module (MDASI-AML/MDS)|Adverse events as graded by NCI CTCAE v4.03|Laboratory abnormalities as graded by NCI CTCAE v4.03|For the intensive study, the plasma trough concentration (Ctrough) will be analyzed|QTc interval|PROs as measured by Patient Global Impression of Change (PGIC)|Patient Reported Outcomes (PROs) as measured by EuroQoL 5 Dimension questionnaire 5-Level version (EQ-5D-5L)|Patient Reported Outcomes (PROs) as measured by Patient Global Impression of Symptoms (PGIS)|Complete Remission with incomplete hematologic recovery (CRi)|Rate of morphological leukemia-free state (MLFS)|Rate of Partial Remission (PR)|Rate of Complete Remission with partial hematological recovery (CRh) for the Non-intensive study only only|Minimum Observed Plasma Trough Concentratrion of glasdegib in the Intensive Study|Minimum Observed Plasma Trough Concentration of glasdegib in the Non-intensive study","Scale is from 0-10 where 0 is not present and 10 is as bad as you can image.|Response as defined by the 2017 European LeukemiaNet (ELN) recommendations.|5 years after last subject randomized, consent withdrawal, or death|Measurement Scale from 0-10.|PK samples taken on Induction(s) Day 1 (1 and 4 hours post induction); Induction(s) Day 10 (pre-dose, 1 and 4 hours post dose); Day 1 of each Consolidation cycle (pre-dose, 1 and 4 hours post dose)|One question asking for description of leukemia symptoms.|Series of questions that ask for information that best describes health.|One question asking for information regarding leukemia symptoms.|Its the minimum trough concentration in plasma of glasdegib following multiple daily dosing to steady state.|It is the minimum trough concentration in plasma of glasdegib following multiple daily dosing to steady state.","5 years after last subject randomized, consent withdrawal, or death|2 years after last dose of study therapy|5 years after last patient randomized, withdrawal, or death|5 years after last subject randomized, withdrawal, or death|Day 10 of Induction Cycle and Day 1 of each Consolidation Cycle|Cycle 1 Day 15 and Cycles 2 and 3 on Day 1","ClinicalTrials.gov_Inquiries@pfizer.com","Pfizer CT.gov Call Center","1-800-718-1021","Nagoya, Aichi, Japan, 466-8650|Akita, Japan, 010-8543 Kyushu University HospitalFukuoka, Japan, 812-8582 National Hospital Organization Kumamoto Medical CenterKumamoto, Japan, 860-0008 Nagasaki University HospitalNagasaki, Japan, 852-8501 Tokyo Medical University HospitalTokyo, Japan, 160-0023 Korea, Republic Of, Jeollabuk-Do Chonbuk National University Hospital (Drug Shipment Only)Jeonju-Si, Jeollabuk-Do, Korea, Republic Of, 54907 Chonbuk National University HospitalJeonju-Si, Jeollabuk-Do, Korea, Republic Of, 54907 Korea, Republic Of, Jeollanam-Do Chonnam National University Hwasun HospitalHwasun-Gun, Jeollanam-Do, Korea, Republic Of, 58128 Korea, Republic Of Department Of Pharmacy, Inje University Busan Paik HospitalBusan, Korea, Republic Of, 47392 Inje University Busan Paik HospitalBusan, Korea, Republic Of, 47392 Clinical Trial Pharmacy, Keimyung University Dongsan HospitalDaegu, Korea, Republic Of, 41931 Keimyung University Dongsan HospitalDaegu, Korea, Republic Of, 41931 Gachon University Gil Medical CenterIncheon, Korea, Republic Of, 21565 Seoul National University HospitalSeoul, Korea, Republic Of, 03080 Clinical Trial Center, Severance Hospital, Yonsei University Health System (Drug Shipment Only)Seoul, Korea, Republic Of, 03722 Severance Hospital, Yonsei University Health SystemSeoul, Korea, Republic Of, 03722 Department Of Pharmacy, Samsung Medical Center (Drug Shipment Only)Seoul, Korea, Republic Of, 06351 Samsung Medical CenterSeoul, Korea, Republic Of, 06351 The Catholic University Of Korea Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591 The Catholic University Of KoreaSeoul, Korea, Republic Of, 06591 Russian Federation State Budgetary Institution Of Ryazan Region 'Regional Clinical Hospital' (Sbi Rr Rch)Ryazan, Russian Federation, 390039 Taiwan Department Of Clinical Trial Pharmacy, Taipei Veterans General HospitalTaipei, Taiwan, 11217 Taipei Veterans General HospitalTaipei, Taiwan, 11217 Chang Gung Memorial Hospital-Linkou BranchTaoyuan City, Taiwan, 333 Chemotherapy Pharmacy, Chang Gung Memorial Hospital-Linkou BranchTaoyuan City, Taiwan, 333|Yoshida-Gun, Fukui, Japan, 910-1193|Maebashi, Gunma, Japan, 371-8511|Kobe-Shi, Hyogo, Japan, 650-0017|Yokohama, Kanagawa, Japan, 232-0024|Sendai, Miyagi, Japan, 980-8574|Osaka-City, Osaka, Japan, 545-8586 Kindai University HospitalOsaka-Sayama, Osaka, Japan, 589-8511|Sunto-Gun, Shizuoka, Japan, 411-8777|Tachikawa, Tokyo, Japan, 190-0014|Orange, California, United States, 92868-3201 Uc Irvine Medical CenterOrange, California, United States, 92868-3201|Lake Success, New York, United States, 11042 North Shore University HospitalManhasset, New York, United States, 11030 Long Island Jewish Medical CenterNew Hyde Park, New York, United States, 11040|Cleveland, Ohio, United States, 44106 Cleveland Clinic FoundationCleveland, Ohio, United States, 44195","California|New York|Ohio","Japan|United States","Aichi Japanese Red Cross Nagoya Daini Hospital|Akita University Hospital|Fukui University Of Fukui Hospital|Gunma Gunma University Hospital|Hyogo Kobe University Hospital|Kanagawa Yokohama City University Medical Center|Miyagi Tohoku University Hospital|Osaka Osaka City University Hospital|Shizuoka Shizuoka Cancer Center|Tokyo National Hospital Organization Disaster Medical Center|Uc Irvine Health - Chao Family Comprehensive Cancer Center|Northwell Health Monter Cancer Center|Taussig Cancer Center Investigational Pharmacy",{"$nulls":3},"Pfizer CT.gov Call Center","2018-07-14","2020-05-25T16:39:27.959","2020-05-26T17:10:42.972","NCT03416179"]
["5ecbf4c011702c1b1b916bbe","NCT03416179","2018-08-07","Pfizer","PFE","Recruiting","A Study Evaluating Intensive Chemotherapy With or Without Glasdegib or Azacitidine With or Without Glasdegib In Patients With Previously Untreated Acute Myeloid Leukemia (BRIGHT AML1019)","Glasdegib|Cytarabine|Daunorubicin|Azacitidine","Hh Inhibitor|DNA Polymerase Inhibitor|Nucleic Acid Synthesis Inhibitor|TOP2 Inhibitor|DNA Mtase Inhibitor","Yes","['Glasdegib']","Unknown",null,"Phase 3",4,720,"Anticipated","2018-04-20","2023-02-16","OS","Overall Survival",{"$nulls":3},"Glasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).\n\nGlasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).","Two separate registration trials conducted under one protocol number are proposed to adequately and independently evaluate the addition of glasdegib in intensive and non-intensive chemotherapy populations. Each study will have an experimental treatment arm and a placebo arm. Endpoints are the same for each study except where specifically indicated.\n\nAssignment to the Intensive Study or the Non-Intensive Study will be made by the Investigator based on the 2017 European LeukemiaNet (ELN) recommendations.\n\nStudy B1371019 is a randomized (1:1), double-blind, multi-center, placebo controlled study of chemotherapy in combination with glasdegib versus chemotherapy in combination with placebo in adult patients with previously untreated AML.\n\nGlasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).\n\nGlasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).","A RANDOMIZED (1:1), DOUBLE-BLIND, MULTI-CENTER, PLACEBO CONTROLLED STUDY EVALUATING INTENSIVE CHEMOTHERAPY WITH OR WITHOUT GLASDEGIB (PF-04449913) OR AZACITIDINE (AZA) WITH OR WITHOUT GLASDEGIB IN PATIENTS WITH PREVIOUSLY UNTREATED ACUTE MYELOID LEUKEMIA","B1371019","Leukemia, Myeloid, Acute","Acute Leukemia|Acute Myeloid Leukemia|Myeloid Leukemia|Leukemia","Oncology Hematological","Oncology","Experimental|Placebo Comparator","Arm A (Intensive Study)|Arm B (Intensive Study)|Arm A (Non-intensive study)|Arm B (Non-intensive study)","Glasdegib + '7+3' Induction(s)|Placebo + '7+3' Induction(s)|Glasdegib + azacitidine|Placebo + azacitidine","Drug|Procedure","glasdegib|daunorubicin + cytarabine|cytarabine|HSCT|Placebo|azacitidine","Daily Glasdegib (100 mg, PO), beginning on Day 1 and is to continue up to 2 years post randomization.\n\nFollowing consolidation therapy, glasdegib or placebo will be administered daily for up to 2 years after randomization or until they have minimal residual disease (MRD) negative disease, whichever comes first.\n\nDaily Glasdegib (100 mg, PO) or matching placebo will continue throughout Induction(s) and Consolidation therapies regardless of dose modifications/delays in the chemotherapy.|Consolidation with single agent cytarabine 3 g/m2 IV for adults <60 years and 1 g/m2 for adults 60 years over 3 BID on Days 1, 3, and 5, every 28 days for up to 4 cycles or alternative single agent cytarabine consolidation schedules may be used per local prescribing information.|If required, and done per standard of care post Induction(s).|Azacitidine (75 mg/m2, SC or IV) daily for 7 days, in 28 day cycles for as long as they do not meet the criteria for disease progression, unacceptable toxicity, consent withdrawal, or death.|Matching placebo (PO) is to be administered by mouth daily beginning on Day 1 of chemotherapy and will continue if subjects demonstrate reasonable evidence of clinical benefit and do not meet the criteria for progression regardless of any delays/modifications in the chemotherapy treatment. Subjects will continue placebo until disease progression, unacceptable toxicity, consent withdrawal, or death, whichever comes first.","PF-04449913","Arm A (Intensive Study)|Arm B (Intensive Study)|Arm A (Non-intensive study)|Arm B (Non-intensive study)","\n\nSubjects must meet all of the following inclusion criteria to be eligible for enrollment into the Intensive and Non Intensive study (unless where indicated):\n\n 1.  Subjects with untreated AML according to the World Health Organization (WHO) 2016 Classification2, including those with: * AML arising from MDS or another antecedent hematologic disease (AHD).\n      * AML after previous cytotoxic therapy or radiation (secondary AML).\n     \n     \n 2.  18 years of age (In Japan, 20 years of age).\n 3.  Adequate Organ Function as defined by the following: * Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) 3 x upper limit of normal (ULN), excluding subjects with liver function abnormalities due to underlying malignancy.\n      * Total serum bilirubin 2 x ULN (except subjects with documented Gilbert's syndrome).\n      * Estimated creatinine clearance 30 mL/min as calculated using the standard method for the institution.\n     \n     \n 4.  QTc interval 470 msec using the Fridericia correction (QTcF).\n 5.  All anti cancer treatments (unless specified) should be discontinued 2 weeks from study entry, for example: targeted chemotherapy, radiotherapy, investigational agents, hormones, anagrelide or cytokines. * For control of rapidly progressing leukemia, all trans retinoic acid (ATRA), hydroxyurea, and/or leukopheresis may be used before and for up to 1 week after the first dose of glasdegib.\n     \n     \n 6.  Serum or urine pregnancy test (for female subjects of childbearing potential) with a minimum sensitivity of 25 IU/L or equivalent units of human chorionic gonadotropin (hCG) negative at screening.\n 7.  Male and female subjects of childbearing potential and at risk for pregnancy must agree to use at least one highly effective method of contraception throughout the study and for 180 days after the last dose of azacitidine, cytarabine, or daunorubicin; and the last dose of glasdegib or placebo, whichever occurs later.\n 8.  Female subjects of non childbearing potential must meet at least 1 of the following criteria: 1. Have undergone a documented hysterectomy and/or bilateral oophorectomy;\n      2. Have medically confirmed ovarian failure; or\n      3. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; status may be confirmed by having a serum follicle stimulating hormone (FSH) level confirming the postmenopausal state.\n     \n     All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential.\n     \n     \n 9.  Consent to a saliva sample collection for a germline comparator, unless prohibited by local regulations or ethics committee (EC) decision.\n 10. Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.\n 11. Subjects who are willing and able to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures (including bone marrow [BM] assessments).\n\n","\n\nSubjects with any of the following characteristics/conditions will not be included in the study:\n\n 1.  Acute Promyelocytic Leukemia (APL) and APLwith PML RARA, subjects (WHO 2016 classification).\n 2.  AML with BCR ABL1 or t(9;22)(q34;q11.2) as a sole abnormality. * Complex genetics may include t(9;22) cytogenetic translocation.\n     \n     \n 3.  Subjects with known active CNS leukemia.\n 4.  Participation in other clinical studies involving other investigational drug(s) (Phases 1 4) within 4 weeks prior study entry and/or during study participation.\n 5.  Subjects known to be refractory to platelet or packed red cell transfusions per Institutional Guidelines, or a patient who refuses blood product support.\n 6.  Subjects with another active malignancy on treatment with the exception of basal cell carcinoma, non melanoma skin cancer, cervical carcinoma in situ. Other prior or concurrent malignancies will be considered on a case by case basis.\n 7.  Any one of the following ongoing or in the previous 6 months: myocardial infarction, congenital long QT syndrome, Torsades de pointes, symptomatic arrhythmias (including sustained ventricular tachyarrhythmia), right or left bundle branch block and bifascicular block, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (CHF New York Heart Association class III or IV), cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism; as well as bradycardia defined as <50 bpms.\n 8.  Subjects with an active, life threatening or clinically significant uncontrolled systemic infection not related to AML.\n 9.  Subjects with left ventricular ejection fraction (LVEF) <50% are excluded from the Intensive Chemotherapy Study only.\n 10. Cumulative anthracycline dose equivalent of 550 mg/m2 of daunorubicin for the Intensive Chemotherapy Study only.\n 11. Known malabsorption syndrome or other condition that may significantly impair absorption of study medication in the investigator's judgment (eg, gastrectomy, lap band, Crohn's disease) and inability or unwillingness to swallow tablets or capsules.\n 12. Current use or anticipated requirement for drugs that are known strong CYP3A4/5 inducers.\n 13. Concurrent administration of herbal preparations.\n 14. Major surgery or radiation within 4 weeks of starting study treatment.\n 15. Documented or suspected hypersensitivity to any one of the following: * For subjects assigned to intensive chemotherapy, documented or suspected hypersensitivity to cytarabine (not including drug fever or exanthema, including known cerebellar side effects) or daunorubicin.\n      * For subjects assigned to non intensive chemotherapy, documented or suspected hypersensitivity to azacitidine or mannitol.\n     \n     \n 16. Known active drug or alcohol abuse.\n 17. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.\n 18. Pregnant females or breastfeeding female subjects.\n 19. Known recent or active suicidal ideation or behavior.\n 20. Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.","FSH",null,"Protein","Ovary","Actual","2018-01-31","Actual","Anticipated","2025-07-22","Anticipated","2018-08-01","2017-12-21","2018-01-23","2018-08-03","Yes","glasdegib;\nuntreated;\nHedgehog Inhibitor","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"All",null,"No","Yes\nInformation relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests",null,"URL: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1371019&StudyName=A+Randomized+%281%3A1%29%2C+Double+Blind%2C+Multi+Center%2C+Placebo+Controlled+Study+Evaluating+Intensive+Chemotherapy+With+Or+Without+Glasdegib+%28pf+04449913%29+Or+Azacitidine+%28aza%29+With+Or+Without+Glasdegib+In+Patients+With+Previously+Untreated+Acute+Myeloid+Leukemia [https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1371019&StudyName=A+Randomized+%281%3A1%29%2C+Double+Blind%2C+Multi+Center%2C+Placebo+Controlled+Study+Evaluating+Intensive+Chemotherapy+With+Or+Without+Glasdegib+%28pf+04449913%29+Or+Azacitidine+%28aza%29+With+Or+Without+Glasdegib+In+Patients+With+Previously+Untreated+Acute+Myeloid+Leukemia] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To obtain contact information for a study center near you, click here.",null,"Yes","No",{"$nulls":17},"2017-002822-19|BRIGHT|BRIGHT AML1019","EudraCT Number|Alias Study Number","Overall survival","5 years after last subject randomized",null,"Fatigue score measured by the MD Anderson Symptom Inventory (MDASI)-AML/MDS questionnaire|Rate of Complete Remission (CR) (including CR with minimal residual disease (MRD)-negative as assessed by multiparametric flow cytometry)|Duration of response (defined as CR [includes CR-MRD negative]/CRi or CR/CRh as appropriate)|Time to response (CR[includes CR-MRD negative)]/CR with partial hematologic rcovery (CRh) as appropriate)|Event-free Survival|Patient Reported Outcomes (PROs) as measured by the M.D. Anderson Symptom Inventory AML/MDS Module (MDASI-AML/MDS)|Adverse events as graded by NCI CTCAE v4.03|Laboratory abnormalities as graded by NCI CTCAE v4.03|For the intensive study, the plasma trough concentration (Ctrough) will be analyzed|QTc interval|PROs as measured by Patient Global Impression of Change (PGIC)|Patient Reported Outcomes (PROs) as measured by EuroQoL 5 Dimension questionnaire 5-Level version (EQ-5D-5L)|Patient Reported Outcomes (PROs) as measured by Patient Global Impression of Symptoms (PGIS)|Complete Remission with incomplete hematologic recovery (CRi)|Rate of morphological leukemia-free state (MLFS)|Rate of Partial Remission (PR)|Rate of Complete Remission with partial hematological recovery (CRh) for the Non-intensive study only only|Minimum Observed Plasma Trough Concentratrion of glasdegib in the Intensive Study|Minimum Observed Plasma Trough Concentration of glasdegib in the Non-intensive study","Scale is from 0-10 where 0 is not present and 10 is as bad as you can image.|Response as defined by the 2017 European LeukemiaNet (ELN) recommendations.|5 years after last subject randomized, consent withdrawal, or death|Measurement Scale from 0-10.|PK samples taken on Induction(s) Day 1 (1 and 4 hours post induction); Induction(s) Day 10 (pre-dose, 1 and 4 hours post dose); Day 1 of each Consolidation cycle (pre-dose, 1 and 4 hours post dose)|One question asking for description of leukemia symptoms.|Series of questions that ask for information that best describes health.|One question asking for information regarding leukemia symptoms.|Its the minimum trough concentration in plasma of glasdegib following multiple daily dosing to steady state.|It is the minimum trough concentration in plasma of glasdegib following multiple daily dosing to steady state.","5 years after last subject randomized, consent withdrawal, or death|2 years after last dose of study therapy|5 years after last patient randomized, withdrawal, or death|5 years after last subject randomized, withdrawal, or death|Day 10 of Induction Cycle and Day 1 of each Consolidation Cycle|Cycle 1 Day 15 and Cycles 2 and 3 on Day 1","ClinicalTrials.gov_Inquiries@pfizer.com","Pfizer CT.gov Call Center","1-800-718-1021","Nagoya, Aichi, Japan, 466-8650|Akita, Japan, 010-8543 Kyushu University HospitalFukuoka, Japan, 812-8582 National Hospital Organization Kumamoto Medical CenterKumamoto, Japan, 860-0008 Nagasaki University HospitalNagasaki, Japan, 852-8501 Tokyo Medical University HospitalTokyo, Japan, 160-0023 Korea, Republic Of, Jeollabuk-Do Chonbuk National University HospitalJeonju-Si, Jeollabuk-Do, Korea, Republic Of, 54907 Korea, Republic Of, Jeollanam-Do Chonnam National University Hwasun HospitalHwasun-Gun, Jeollanam-Do, Korea, Republic Of, 58128 Korea, Republic Of Department Of Pharmacy, Inje University Busan Paik HospitalBusan, Korea, Republic Of, 47392 Inje University Busan Paik HospitalBusan, Korea, Republic Of, 47392 Clinical Trial Pharmacy, Keimyung University Dongsan HospitalDaegu, Korea, Republic Of, 41931 Keimyung University Dongsan HospitalDaegu, Korea, Republic Of, 41931 Gachon University Gil Medical CenterIncheon, Korea, Republic Of, 21565 Seoul National University HospitalSeoul, Korea, Republic Of, 03080 Clinical Trial Center, Severance Hospital, Yonsei University Health System (Drug Shipment Only)Seoul, Korea, Republic Of, 03722 Severance Hospital, Yonsei University Health SystemSeoul, Korea, Republic Of, 03722 Department Of Pharmacy, Samsung Medical Center (Drug Shipment Only)Seoul, Korea, Republic Of, 06351 Samsung Medical CenterSeoul, Korea, Republic Of, 06351 The Catholic University Of Korea Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591 The Catholic University Of KoreaSeoul, Korea, Republic Of, 06591 Russian Federation Sbhi Cch No. 40 Hd MoscowMoscow, Russian Federation, 129301 State Budgetary Healthcare Institution Of MoscowMoscow, Russian Federation, 129301 State Budgetary Institution Of Ryazan Region 'Regional Clinical Hospital' (Sbi Rr Rch)Ryazan, Russian Federation, 390039 Drug Shipment Address:Saint Petersburg, Russian Federation, 191024 Fsbi Russrhti Fmba Of|Yoshida-Gun, Fukui, Japan, 910-1193|Maebashi, Gunma, Japan, 371-8511|Kobe-Shi, Hyogo, Japan, 650-0017|Yokohama, Kanagawa, Japan, 232-0024|Sendai, Miyagi, Japan, 980-8574|Osaka-City, Osaka, Japan, 545-8586 Kindai University HospitalOsaka-Sayama, Osaka, Japan, 589-8511|Sunto-Gun, Shizuoka, Japan, 411-8777|Tachikawa, Tokyo, Japan, 190-0014|Barcelona, Spain, 08003 Taiwan Department Of Clinical Trial Pharmacy, Taipei Veterans General HospitalTaipei, Taiwan, 11217 Taipei Veterans General HospitalTaipei, Taiwan, 11217 Division Of Pharmacy, Koo Foundation Sun Yat-Sen Cancer CenterTaipei, Taiwan, 112 Koo Foundation Sun Yat-Sen Cancer CenterTaipei, Taiwan, 112 Chang Gung Memorial Hospital-Linkou BranchTaoyuan City, Taiwan, 333 Chemotherapy Pharmacy, Chang Gung Memorial Hospital-Linkou BranchTaoyuan City, Taiwan, 333|Orange, California, United States, 92868-3201 Uc Irvine Medical CenterOrange, California, United States, 92868-3201|Kansas City, Missouri, United States, 64132|Lake Success, New York, United States, 11042 North Shore University HospitalManhasset, New York, United States, 11030 Long Island Jewish Medical CenterNew Hyde Park, New York, United States, 11040|Cleveland, Ohio, United States, 44106 Cleveland Clinic FoundationCleveland, Ohio, United States, 44195|Nashville, Tennessee, United States, 37203","California|Missouri|New York|Ohio|Tennessee","Japan|Spain|United States","Aichi Japanese Red Cross Nagoya Daini Hospital|Akita University Hospital|Fukui University Of Fukui Hospital|Gunma Gunma University Hospital|Hyogo Kobe University Hospital|Kanagawa Yokohama City University Medical Center|Miyagi Tohoku University Hospital|Osaka Osaka City University Hospital|Shizuoka Shizuoka Cancer Center|Tokyo National Hospital Organization Disaster Medical Center|Hospital Del Mar|Uc Irvine Health - Chao Family Comprehensive Cancer Center|Midamerica Division, Inc., C/O Research Medical Center|Northwell Health Monter Cancer Center|Taussig Cancer Center Investigational Pharmacy|The Sarah Cannon Research Institute",{"$nulls":3},"Pfizer CT.gov Call Center","2018-08-03","2020-05-25T16:39:28.363","2020-05-26T17:10:42.972","NCT03416179"]
["5ecbf4c0feab101b155309e1","NCT03416179","2018-08-14","Pfizer","PFE","Recruiting","A Study Evaluating Intensive Chemotherapy With or Without Glasdegib or Azacitidine With or Without Glasdegib In Patients With Previously Untreated Acute Myeloid Leukemia (BRIGHT AML1019)","Glasdegib|Cytarabine|Daunorubicin|Azacitidine","Hh Inhibitor|DNA Polymerase Inhibitor|Nucleic Acid Synthesis Inhibitor|TOP2 Inhibitor|DNA Mtase Inhibitor","Yes","['Glasdegib']","Unknown",null,"Phase 3",4,720,"Anticipated","2018-04-20","2021-06-13","OS","Overall Survival",{"$nulls":3},"Glasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).\n\nGlasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).","Two separate registration trials conducted under one protocol number are proposed to adequately and independently evaluate the addition of glasdegib in intensive and non-intensive chemotherapy populations. Each study will have an experimental treatment arm and a placebo arm. Endpoints are the same for each study except where specifically indicated.\n\nAssignment to the Intensive Study or the Non-Intensive Study will be made by the Investigator based on the 2017 European LeukemiaNet (ELN) recommendations.\n\nStudy B1371019 is a randomized (1:1), double-blind, multi-center, placebo controlled study of chemotherapy in combination with glasdegib versus chemotherapy in combination with placebo in adult patients with previously untreated AML.\n\nGlasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).\n\nGlasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).","A RANDOMIZED (1:1), DOUBLE-BLIND, MULTI-CENTER, PLACEBO CONTROLLED STUDY EVALUATING INTENSIVE CHEMOTHERAPY WITH OR WITHOUT GLASDEGIB (PF-04449913) OR AZACITIDINE (AZA) WITH OR WITHOUT GLASDEGIB IN PATIENTS WITH PREVIOUSLY UNTREATED ACUTE MYELOID LEUKEMIA","B1371019","Leukemia, Myeloid, Acute","Acute Leukemia|Acute Myeloid Leukemia|Myeloid Leukemia|Leukemia","Oncology Hematological","Oncology","Experimental|Placebo Comparator","Arm A (Intensive Study)|Arm B (Intensive Study)|Arm A (Non-intensive study)|Arm B (Non-intensive study)","Glasdegib + '7+3' Induction(s)|Placebo + '7+3' Induction(s)|Glasdegib + azacitidine|Placebo + azacitidine","Drug|Procedure","glasdegib|daunorubicin + cytarabine|cytarabine|HSCT|Placebo|azacitidine","Daily Glasdegib (100 mg, PO), beginning on Day 1 and is to continue up to 2 years post randomization.\n\nFollowing consolidation therapy, glasdegib or placebo will be administered daily for up to 2 years after randomization or until they have minimal residual disease (MRD) negative disease, whichever comes first.\n\nDaily Glasdegib (100 mg, PO) or matching placebo will continue throughout Induction(s) and Consolidation therapies regardless of dose modifications/delays in the chemotherapy.|Consolidation with single agent cytarabine 3 g/m2 IV for adults <60 years and 1 g/m2 for adults 60 years over 3 BID on Days 1, 3, and 5, every 28 days for up to 4 cycles or alternative single agent cytarabine consolidation schedules may be used per local prescribing information.|If required, and done per standard of care post Induction(s).|Azacitidine (75 mg/m2, SC or IV) daily for 7 days, in 28 day cycles for as long as they do not meet the criteria for disease progression, unacceptable toxicity, consent withdrawal, or death.|Matching placebo (PO) is to be administered by mouth daily beginning on Day 1 of chemotherapy and will continue if subjects demonstrate reasonable evidence of clinical benefit and do not meet the criteria for progression regardless of any delays/modifications in the chemotherapy treatment. Subjects will continue placebo until disease progression, unacceptable toxicity, consent withdrawal, or death, whichever comes first.","PF-04449913","Arm A (Intensive Study)|Arm B (Intensive Study)|Arm A (Non-intensive study)|Arm B (Non-intensive study)","\n\nSubjects must meet all of the following inclusion criteria to be eligible for enrollment into the Intensive and Non Intensive study (unless where indicated):\n\n 1.  Subjects with untreated AML according to the World Health Organization (WHO) 2016 Classification2, including those with: * AML arising from MDS or another antecedent hematologic disease (AHD).\n      * AML after previous cytotoxic therapy or radiation (secondary AML).\n     \n     \n 2.  18 years of age (In Japan, 20 years of age).\n 3.  Adequate Organ Function as defined by the following: * Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) 3 x upper limit of normal (ULN), excluding subjects with liver function abnormalities due to underlying malignancy.\n      * Total serum bilirubin 2 x ULN (except subjects with documented Gilbert's syndrome).\n      * Estimated creatinine clearance 30 mL/min as calculated using the standard method for the institution.\n     \n     \n 4.  QTc interval 470 msec using the Fridericia correction (QTcF).\n 5.  All anti cancer treatments (unless specified) should be discontinued 2 weeks from study entry, for example: targeted chemotherapy, radiotherapy, investigational agents, hormones, anagrelide or cytokines. * For control of rapidly progressing leukemia, all trans retinoic acid (ATRA), hydroxyurea, and/or leukopheresis may be used before and for up to 1 week after the first dose of glasdegib.\n     \n     \n 6.  Serum or urine pregnancy test (for female subjects of childbearing potential) with a minimum sensitivity of 25 IU/L or equivalent units of human chorionic gonadotropin (hCG) negative at screening.\n 7.  Male and female subjects of childbearing potential and at risk for pregnancy must agree to use at least one highly effective method of contraception throughout the study and for 180 days after the last dose of azacitidine, cytarabine, or daunorubicin; and the last dose of glasdegib or placebo, whichever occurs later.\n 8.  Female subjects of non childbearing potential must meet at least 1 of the following criteria: 1. Have undergone a documented hysterectomy and/or bilateral oophorectomy;\n      2. Have medically confirmed ovarian failure; or\n      3. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; status may be confirmed by having a serum follicle stimulating hormone (FSH) level confirming the postmenopausal state.\n     \n     All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential.\n     \n     \n 9.  Consent to a saliva sample collection for a germline comparator, unless prohibited by local regulations or ethics committee (EC) decision.\n 10. Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.\n 11. Subjects who are willing and able to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures (including bone marrow [BM] assessments).\n\n","\n\nSubjects with any of the following characteristics/conditions will not be included in the study:\n\n 1.  Acute Promyelocytic Leukemia (APL) and APLwith PML RARA, subjects (WHO 2016 classification).\n 2.  AML with BCR ABL1 or t(9;22)(q34;q11.2) as a sole abnormality. * Complex genetics may include t(9;22) cytogenetic translocation.\n     \n     \n 3.  Subjects with known active CNS leukemia.\n 4.  Participation in other clinical studies involving other investigational drug(s) (Phases 1 4) within 4 weeks prior study entry and/or during study participation.\n 5.  Subjects known to be refractory to platelet or packed red cell transfusions per Institutional Guidelines, or a patient who refuses blood product support.\n 6.  Subjects with another active malignancy on treatment with the exception of basal cell carcinoma, non melanoma skin cancer, cervical carcinoma in situ. Other prior or concurrent malignancies will be considered on a case by case basis.\n 7.  Any one of the following ongoing or in the previous 6 months: myocardial infarction, congenital long QT syndrome, Torsades de pointes, symptomatic arrhythmias (including sustained ventricular tachyarrhythmia), right or left bundle branch block and bifascicular block, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (CHF New York Heart Association class III or IV), cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism; as well as bradycardia defined as <50 bpms.\n 8.  Subjects with an active, life threatening or clinically significant uncontrolled systemic infection not related to AML.\n 9.  Subjects with left ventricular ejection fraction (LVEF) <50% are excluded from the Intensive Chemotherapy Study only.\n 10. Cumulative anthracycline dose equivalent of 550 mg/m2 of daunorubicin for the Intensive Chemotherapy Study only.\n 11. Known malabsorption syndrome or other condition that may significantly impair absorption of study medication in the investigator's judgment (eg, gastrectomy, lap band, Crohn's disease) and inability or unwillingness to swallow tablets or capsules.\n 12. Current use or anticipated requirement for drugs that are known strong CYP3A4/5 inducers.\n 13. Concurrent administration of herbal preparations.\n 14. Major surgery or radiation within 4 weeks of starting study treatment.\n 15. Documented or suspected hypersensitivity to any one of the following: * For subjects assigned to intensive chemotherapy, documented or suspected hypersensitivity to cytarabine (not including drug fever or exanthema, including known cerebellar side effects) or daunorubicin.\n      * For subjects assigned to non intensive chemotherapy, documented or suspected hypersensitivity to azacitidine or mannitol.\n     \n     \n 16. Known active drug or alcohol abuse.\n 17. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.\n 18. Pregnant females or breastfeeding female subjects.\n 19. Known recent or active suicidal ideation or behavior.\n 20. Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.","FSH",null,"Protein","Ovary","Actual","2018-01-31","Actual","Anticipated","2025-07-22","Anticipated","2018-08-01","2017-12-21","2018-01-23","2018-08-10","Yes","glasdegib;\nuntreated;\nHedgehog Inhibitor","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"All",null,"No","Yes\nInformation relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests",null,"URL: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1371019&StudyName=A+Randomized+%281%3A1%29%2C+Double+Blind%2C+Multi+Center%2C+Placebo+Controlled+Study+Evaluating+Intensive+Chemotherapy+With+Or+Without+Glasdegib+%28pf+04449913%29+Or+Azacitidine+%28aza%29+With+Or+Without+Glasdegib+In+Patients+With+Previously+Untreated+Acute+Myeloid+Leukemia [https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1371019&StudyName=A+Randomized+%281%3A1%29%2C+Double+Blind%2C+Multi+Center%2C+Placebo+Controlled+Study+Evaluating+Intensive+Chemotherapy+With+Or+Without+Glasdegib+%28pf+04449913%29+Or+Azacitidine+%28aza%29+With+Or+Without+Glasdegib+In+Patients+With+Previously+Untreated+Acute+Myeloid+Leukemia] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To obtain contact information for a study center near you, click here.",null,"Yes","No",{"$nulls":17},"2017-002822-19|BRIGHT|BRIGHT AML1019","EudraCT Number|Alias Study Number","Overall survival","5 years after last subject randomized",null,"Fatigue score measured by the MD Anderson Symptom Inventory (MDASI)-AML/MDS questionnaire|Rate of Complete Remission (CR) (including CR with minimal residual disease (MRD)-negative as assessed by multiparametric flow cytometry)|Duration of response (defined as CR [includes CR-MRD negative]/CRi or CR/CRh as appropriate)|Time to response (CR[includes CR-MRD negative)]/CR with partial hematologic rcovery (CRh) as appropriate)|Event-free Survival|Patient Reported Outcomes (PROs) as measured by the M.D. Anderson Symptom Inventory AML/MDS Module (MDASI-AML/MDS)|Adverse events as graded by NCI CTCAE v4.03|Laboratory abnormalities as graded by NCI CTCAE v4.03|For the intensive study, the plasma trough concentration (Ctrough) will be analyzed|QTc interval|PROs as measured by Patient Global Impression of Change (PGIC)|Patient Reported Outcomes (PROs) as measured by EuroQoL 5 Dimension questionnaire 5-Level version (EQ-5D-5L)|Patient Reported Outcomes (PROs) as measured by Patient Global Impression of Symptoms (PGIS)|Complete Remission with incomplete hematologic recovery (CRi)|Rate of morphological leukemia-free state (MLFS)|Rate of Partial Remission (PR)|Rate of Complete Remission with partial hematological recovery (CRh) for the Non-intensive study only only|Minimum Observed Plasma Trough Concentratrion of glasdegib in the Intensive Study|Minimum Observed Plasma Trough Concentration of glasdegib in the Non-intensive study","Scale is from 0-10 where 0 is not present and 10 is as bad as you can image.|Response as defined by the 2017 European LeukemiaNet (ELN) recommendations.|5 years after last subject randomized, consent withdrawal, or death|Measurement Scale from 0-10.|PK samples taken on Induction(s) Day 1 (1 and 4 hours post induction); Induction(s) Day 10 (pre-dose, 1 and 4 hours post dose); Day 1 of each Consolidation cycle (pre-dose, 1 and 4 hours post dose)|One question asking for description of leukemia symptoms.|Series of questions that ask for information that best describes health.|One question asking for information regarding leukemia symptoms.|Its the minimum trough concentration in plasma of glasdegib following multiple daily dosing to steady state.|It is the minimum trough concentration in plasma of glasdegib following multiple daily dosing to steady state.","5 years after last subject randomized, consent withdrawal, or death|2 years after last dose of study therapy|5 years after last patient randomized, withdrawal, or death|5 years after last subject randomized, withdrawal, or death|Day 10 of Induction Cycle and Day 1 of each Consolidation Cycle|Cycle 1 Day 15 and Cycles 2 and 3 on Day 1","ClinicalTrials.gov_Inquiries@pfizer.com","Pfizer CT.gov Call Center","1-800-718-1021","Nagoya, Aichi, Japan, 466-8650|Akita, Japan, 010-8543 Kyushu University HospitalFukuoka, Japan, 812-8582 National Hospital Organization Kumamoto Medical CenterKumamoto, Japan, 860-0008 Nagasaki University HospitalNagasaki, Japan, 852-8501 Tokyo Medical University HospitalTokyo, Japan, 160-0023 Korea, Republic Of, Jeollabuk-Do Chonbuk National University HospitalJeonju-Si, Jeollabuk-Do, Korea, Republic Of, 54907 Korea, Republic Of, Jeollanam-Do Chonnam National University Hwasun HospitalHwasun-Gun, Jeollanam-Do, Korea, Republic Of, 58128 Korea, Republic Of Department Of Pharmacy, Inje University Busan Paik HospitalBusan, Korea, Republic Of, 47392 Inje University Busan Paik HospitalBusan, Korea, Republic Of, 47392 Clinical Trial Pharmacy, Keimyung University Dongsan HospitalDaegu, Korea, Republic Of, 41931 Keimyung University Dongsan HospitalDaegu, Korea, Republic Of, 41931 Gachon University Gil Medical CenterIncheon, Korea, Republic Of, 21565 Seoul National University HospitalSeoul, Korea, Republic Of, 03080 Clinical Trial Center, Severance Hospital, Yonsei University Health System (Drug Shipment Only)Seoul, Korea, Republic Of, 03722 Severance Hospital, Yonsei University Health SystemSeoul, Korea, Republic Of, 03722 Department Of Pharmacy, Samsung Medical Center (Drug Shipment Only)Seoul, Korea, Republic Of, 06351 Samsung Medical CenterSeoul, Korea, Republic Of, 06351 The Catholic University Of Korea Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591 The Catholic University Of KoreaSeoul, Korea, Republic Of, 06591|Yoshida-Gun, Fukui, Japan, 910-1193|Maebashi, Gunma, Japan, 371-8511|Kobe-Shi, Hyogo, Japan, 650-0017|Yokohama, Kanagawa, Japan, 232-0024|Sendai, Miyagi, Japan, 980-8574|Osaka-City, Osaka, Japan, 545-8586 Kindai University HospitalOsaka-Sayama, Osaka, Japan, 589-8511|Sunto-Gun, Shizuoka, Japan, 411-8777|Tachikawa, Tokyo, Japan, 190-0014|Gdansk, Poland, 80-952 Russian Federation Sbhi Cch No. 40 Hd MoscowMoscow, Russian Federation, 129301 State Budgetary Healthcare Institution Of MoscowMoscow, Russian Federation, 129301 State Budgetary Institution Of Ryazan Region 'Regional Clinical Hospital' (Sbi Rr Rch)Ryazan, Russian Federation, 390039 Drug Shipment Address:Saint Petersburg, Russian Federation, 191024 Fsbi Russrhti Fmba Of|Barcelona, Spain, 08003 Taiwan Department Of Clinical Trial Pharmacy, Taipei Veterans General HospitalTaipei, Taiwan, 11217 Taipei Veterans General HospitalTaipei, Taiwan, 11217 Division Of Pharmacy, Koo Foundation Sun Yat-Sen Cancer CenterTaipei, Taiwan, 112 Koo Foundation Sun Yat-Sen Cancer CenterTaipei, Taiwan, 112 Chang Gung Memorial Hospital-Linkou BranchTaoyuan City, Taiwan, 333 Chemotherapy Pharmacy, Chang Gung Memorial Hospital-Linkou BranchTaoyuan City, Taiwan, 333|Orange, California, United States, 92868-3201 Uc Irvine Medical CenterOrange, California, United States, 92868-3201|Kansas City, Missouri, United States, 64132|Lake Success, New York, United States, 11042 North Shore University HospitalManhasset, New York, United States, 11030 Long Island Jewish Medical CenterNew Hyde Park, New York, United States, 11040|Cleveland, Ohio, United States, 44106 Cleveland Clinic FoundationCleveland, Ohio, United States, 44195|Nashville, Tennessee, United States, 37203","California|Missouri|New York|Ohio|Tennessee","Japan|Poland|Spain|United States","Aichi Japanese Red Cross Nagoya Daini Hospital|Akita University Hospital|Fukui University Of Fukui Hospital|Gunma Gunma University Hospital|Hyogo Kobe University Hospital|Kanagawa Yokohama City University Medical Center|Miyagi Tohoku University Hospital|Osaka Osaka City University Hospital|Shizuoka Shizuoka Cancer Center|Tokyo National Hospital Organization Disaster Medical Center|Klinika Hematologii I Transplantologii Uniwersyteckie Centrum Kliniczne|Hospital Del Mar|Uc Irvine Health - Chao Family Comprehensive Cancer Center|Midamerica Division, Inc., C/O Research Medical Center|Northwell Health Monter Cancer Center|Taussig Cancer Center Investigational Pharmacy|The Sarah Cannon Research Institute",{"$nulls":3},"Pfizer CT.gov Call Center","2018-08-10","2020-05-25T16:39:28.378","2020-05-26T17:10:42.972","NCT03416179"]
["5ecbf4c1307e3d1b1f8d9e44","NCT03416179","2018-09-11","Pfizer","PFE","Recruiting","A Study Evaluating Intensive Chemotherapy With or Without Glasdegib or Azacitidine With or Without Glasdegib In Patients With Previously Untreated Acute Myeloid Leukemia (BRIGHT AML1019)","Glasdegib|Cytarabine|Daunorubicin|Azacitidine","Hh Inhibitor|DNA Polymerase Inhibitor|Nucleic Acid Synthesis Inhibitor|TOP2 Inhibitor|DNA Mtase Inhibitor","Yes","['Glasdegib']","Unknown",null,"Phase 3",4,720,"Anticipated","2018-04-20","2021-06-13","OS","Overall Survival",{"$nulls":3},"Glasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).\n\nGlasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).","Two separate registration trials conducted under one protocol number are proposed to adequately and independently evaluate the addition of glasdegib in intensive and non-intensive chemotherapy populations. Each study will have an experimental treatment arm and a placebo arm. Endpoints are the same for each study except where specifically indicated.\n\nAssignment to the Intensive Study or the Non-Intensive Study will be made by the Investigator based on the 2017 European LeukemiaNet (ELN) recommendations.\n\nStudy B1371019 is a randomized (1:1), double-blind, multi-center, placebo controlled study of chemotherapy in combination with glasdegib versus chemotherapy in combination with placebo in adult patients with previously untreated AML.\n\nGlasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).\n\nGlasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).","A RANDOMIZED (1:1), DOUBLE-BLIND, MULTI-CENTER, PLACEBO CONTROLLED STUDY EVALUATING INTENSIVE CHEMOTHERAPY WITH OR WITHOUT GLASDEGIB (PF-04449913) OR AZACITIDINE (AZA) WITH OR WITHOUT GLASDEGIB IN PATIENTS WITH PREVIOUSLY UNTREATED ACUTE MYELOID LEUKEMIA","B1371019","Leukemia, Myeloid, Acute","Acute Leukemia|Acute Myeloid Leukemia|Myeloid Leukemia|Leukemia","Oncology Hematological","Oncology","Experimental|Placebo Comparator","Arm A (Intensive Study)|Arm B (Intensive Study)|Arm A (Non-intensive study)|Arm B (Non-intensive study)","Glasdegib + '7+3' Induction(s)|Placebo + '7+3' Induction(s)|Glasdegib + azacitidine|Placebo + azacitidine","Drug|Procedure","glasdegib|daunorubicin + cytarabine|cytarabine|HSCT|Placebo|azacitidine","Daily Glasdegib (100 mg, PO), beginning on Day 1 and is to continue up to 2 years post randomization.\n\nFollowing consolidation therapy, glasdegib or placebo will be administered daily for up to 2 years after randomization or until they have minimal residual disease (MRD) negative disease, whichever comes first.\n\nDaily Glasdegib (100 mg, PO) or matching placebo will continue throughout Induction(s) and Consolidation therapies regardless of dose modifications/delays in the chemotherapy.|Consolidation with single agent cytarabine 3 g/m2 IV for adults <60 years and 1 g/m2 for adults 60 years over 3 BID on Days 1, 3, and 5, every 28 days for up to 4 cycles or alternative single agent cytarabine consolidation schedules may be used per local prescribing information.|If required, and done per standard of care post Induction(s).|Azacitidine (75 mg/m2, SC or IV) daily for 7 days, in 28 day cycles for as long as they do not meet the criteria for disease progression, unacceptable toxicity, consent withdrawal, or death.|Matching placebo (PO) is to be administered by mouth daily beginning on Day 1 of chemotherapy and will continue if subjects demonstrate reasonable evidence of clinical benefit and do not meet the criteria for progression regardless of any delays/modifications in the chemotherapy treatment. Subjects will continue placebo until disease progression, unacceptable toxicity, consent withdrawal, or death, whichever comes first.","PF-04449913","Arm A (Intensive Study)|Arm B (Intensive Study)|Arm A (Non-intensive study)|Arm B (Non-intensive study)","\n\nSubjects must meet all of the following inclusion criteria to be eligible for enrollment into the Intensive and Non Intensive study (unless where indicated):\n\n 1.  Subjects with untreated AML according to the World Health Organization (WHO) 2016 Classification2, including those with: * AML arising from MDS or another antecedent hematologic disease (AHD).\n      * AML after previous cytotoxic therapy or radiation (secondary AML).\n     \n     \n 2.  18 years of age (In Japan, 20 years of age).\n 3.  Adequate Organ Function as defined by the following: * Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) 3 x upper limit of normal (ULN), excluding subjects with liver function abnormalities due to underlying malignancy.\n      * Total serum bilirubin 2 x ULN (except subjects with documented Gilbert's syndrome).\n      * Estimated creatinine clearance 30 mL/min as calculated using the standard method for the institution.\n     \n     \n 4.  QTc interval 470 msec using the Fridericia correction (QTcF).\n 5.  All anti cancer treatments (unless specified) should be discontinued 2 weeks from study entry, for example: targeted chemotherapy, radiotherapy, investigational agents, hormones, anagrelide or cytokines. * For control of rapidly progressing leukemia, all trans retinoic acid (ATRA), hydroxyurea, and/or leukopheresis may be used before and for up to 1 week after the first dose of glasdegib.\n     \n     \n 6.  Serum or urine pregnancy test (for female subjects of childbearing potential) with a minimum sensitivity of 25 IU/L or equivalent units of human chorionic gonadotropin (hCG) negative at screening.\n 7.  Male and female subjects of childbearing potential and at risk for pregnancy must agree to use at least one highly effective method of contraception throughout the study and for 180 days after the last dose of azacitidine, cytarabine, or daunorubicin; and the last dose of glasdegib or placebo, whichever occurs later.\n 8.  Female subjects of non childbearing potential must meet at least 1 of the following criteria: 1. Have undergone a documented hysterectomy and/or bilateral oophorectomy;\n      2. Have medically confirmed ovarian failure; or\n      3. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; status may be confirmed by having a serum follicle stimulating hormone (FSH) level confirming the postmenopausal state.\n     \n     All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential.\n     \n     \n 9.  Consent to a saliva sample collection for a germline comparator, unless prohibited by local regulations or ethics committee (EC) decision.\n 10. Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.\n 11. Subjects who are willing and able to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures (including bone marrow [BM] assessments).\n\n","\n\nSubjects with any of the following characteristics/conditions will not be included in the study:\n\n 1.  Acute Promyelocytic Leukemia (APL) and APLwith PML RARA, subjects (WHO 2016 classification).\n 2.  AML with BCR ABL1 or t(9;22)(q34;q11.2) as a sole abnormality. * Complex genetics may include t(9;22) cytogenetic translocation.\n     \n     \n 3.  Subjects with known active CNS leukemia.\n 4.  Participation in other clinical studies involving other investigational drug(s) (Phases 1 4) within 4 weeks prior study entry and/or during study participation.\n 5.  Subjects known to be refractory to platelet or packed red cell transfusions per Institutional Guidelines, or a patient who refuses blood product support.\n 6.  Subjects with another active malignancy on treatment with the exception of basal cell carcinoma, non melanoma skin cancer, cervical carcinoma in situ. Other prior or concurrent malignancies will be considered on a case by case basis.\n 7.  Any one of the following ongoing or in the previous 6 months: myocardial infarction, congenital long QT syndrome, Torsades de pointes, symptomatic arrhythmias (including sustained ventricular tachyarrhythmia), right or left bundle branch block and bifascicular block, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (CHF New York Heart Association class III or IV), cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism; as well as bradycardia defined as <50 bpms.\n 8.  Subjects with an active, life threatening or clinically significant uncontrolled systemic infection not related to AML.\n 9.  Subjects with left ventricular ejection fraction (LVEF) <50% are excluded from the Intensive Chemotherapy Study only.\n 10. Cumulative anthracycline dose equivalent of 550 mg/m2 of daunorubicin for the Intensive Chemotherapy Study only.\n 11. Known malabsorption syndrome or other condition that may significantly impair absorption of study medication in the investigator's judgment (eg, gastrectomy, lap band, Crohn's disease) and inability or unwillingness to swallow tablets or capsules.\n 12. Current use or anticipated requirement for drugs that are known strong CYP3A4/5 inducers.\n 13. Concurrent administration of herbal preparations.\n 14. Major surgery or radiation within 4 weeks of starting study treatment.\n 15. Documented or suspected hypersensitivity to any one of the following: * For subjects assigned to intensive chemotherapy, documented or suspected hypersensitivity to cytarabine (not including drug fever or exanthema, including known cerebellar side effects) or daunorubicin.\n      * For subjects assigned to non intensive chemotherapy, documented or suspected hypersensitivity to azacitidine or mannitol.\n     \n     \n 16. Known active drug or alcohol abuse.\n 17. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.\n 18. Pregnant females or breastfeeding female subjects.\n 19. Known recent or active suicidal ideation or behavior.\n 20. Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.","FSH",null,"Protein","Ovary","Actual","2018-01-31","Actual","Anticipated","2025-07-22","Anticipated","2018-09-01","2017-12-21","2018-01-23","2018-09-07","Yes","glasdegib;\nuntreated;\nHedgehog Inhibitor","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"All",null,"No","Yes\nInformation relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests",null,"URL: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1371019&StudyName=A+Randomized+%281%3A1%29%2C+Double+Blind%2C+Multi+Center%2C+Placebo+Controlled+Study+Evaluating+Intensive+Chemotherapy+With+Or+Without+Glasdegib+%28pf+04449913%29+Or+Azacitidine+%28aza%29+With+Or+Without+Glasdegib+In+Patients+With+Previously+Untreated+Acute+Myeloid+Leukemia [https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1371019&StudyName=A+Randomized+%281%3A1%29%2C+Double+Blind%2C+Multi+Center%2C+Placebo+Controlled+Study+Evaluating+Intensive+Chemotherapy+With+Or+Without+Glasdegib+%28pf+04449913%29+Or+Azacitidine+%28aza%29+With+Or+Without+Glasdegib+In+Patients+With+Previously+Untreated+Acute+Myeloid+Leukemia] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To obtain contact information for a study center near you, click here.",null,"Yes","No",{"$nulls":17},"2017-002822-19|BRIGHT|BRIGHT AML1019","EudraCT Number|Alias Study Number","Overall survival","5 years after last subject randomized",null,"Fatigue score measured by the MD Anderson Symptom Inventory (MDASI)-AML/MDS questionnaire|Rate of Complete Remission (CR) (including CR with minimal residual disease (MRD)-negative as assessed by multiparametric flow cytometry)|Duration of response (defined as CR [includes CR-MRD negative]/CRi or CR/CRh as appropriate)|Time to response (CR[includes CR-MRD negative)]/CR with partial hematologic rcovery (CRh) as appropriate)|Event-free Survival|Patient Reported Outcomes (PROs) as measured by the M.D. Anderson Symptom Inventory AML/MDS Module (MDASI-AML/MDS)|Adverse events as graded by NCI CTCAE v4.03|Laboratory abnormalities as graded by NCI CTCAE v4.03|For the intensive study, the plasma trough concentration (Ctrough) will be analyzed|QTc interval|PROs as measured by Patient Global Impression of Change (PGIC)|Patient Reported Outcomes (PROs) as measured by EuroQoL 5 Dimension questionnaire 5-Level version (EQ-5D-5L)|Patient Reported Outcomes (PROs) as measured by Patient Global Impression of Symptoms (PGIS)|Complete Remission with incomplete hematologic recovery (CRi)|Rate of morphological leukemia-free state (MLFS)|Rate of Partial Remission (PR)|Rate of Complete Remission with partial hematological recovery (CRh) for the Non-intensive study only only|Minimum Observed Plasma Trough Concentratrion of glasdegib in the Intensive Study|Minimum Observed Plasma Trough Concentration of glasdegib in the Non-intensive study","Scale is from 0-10 where 0 is not present and 10 is as bad as you can image.|Response as defined by the 2017 European LeukemiaNet (ELN) recommendations.|5 years after last subject randomized, consent withdrawal, or death|Measurement Scale from 0-10.|PK samples taken on Induction(s) Day 1 (1 and 4 hours post induction); Induction(s) Day 10 (pre-dose, 1 and 4 hours post dose); Day 1 of each Consolidation cycle (pre-dose, 1 and 4 hours post dose)|One question asking for description of leukemia symptoms.|Series of questions that ask for information that best describes health.|One question asking for information regarding leukemia symptoms.|Its the minimum trough concentration in plasma of glasdegib following multiple daily dosing to steady state.|It is the minimum trough concentration in plasma of glasdegib following multiple daily dosing to steady state.","5 years after last subject randomized, consent withdrawal, or death|2 years after last dose of study therapy|5 years after last patient randomized, withdrawal, or death|5 years after last subject randomized, withdrawal, or death|Day 10 of Induction Cycle and Day 1 of each Consolidation Cycle|Cycle 1 Day 15 and Cycles 2 and 3 on Day 1","ClinicalTrials.gov_Inquiries@pfizer.com","Pfizer CT.gov Call Center","1-800-718-1021","Brno, Czechia, 625 00 Nemocnicni LekarnaBrno, Czechia, 625 00|Nagoya, Aichi, Japan, 466-8650|Akita, Japan, 010-8543 Kyushu University HospitalFukuoka, Japan, 812-8582 National Hospital Organization Kumamoto Medical CenterKumamoto, Japan, 860-0008 Nagasaki University HospitalNagasaki, Japan, 852-8501 Tokyo Medical University HospitalTokyo, Japan, 160-0023 Korea, Republic Of, Jeollabuk-Do Chonbuk National University HospitalJeonju-Si, Jeollabuk-Do, Korea, Republic Of, 54907 Korea, Republic Of, Jeollanam-Do Chonnam National University Hwasun HospitalHwasun-Gun, Jeollanam-Do, Korea, Republic Of, 58128 Korea, Republic Of Department Of Pharmacy, Inje University Busan Paik HospitalBusan, Korea, Republic Of, 47392 Inje University Busan Paik HospitalBusan, Korea, Republic Of, 47392 Clinical Trial Pharmacy, Keimyung University Dongsan HospitalDaegu, Korea, Republic Of, 41931 Keimyung University Dongsan HospitalDaegu, Korea, Republic Of, 41931 Gachon University Gil Medical CenterIncheon, Korea, Republic Of, 21565 Seoul National University HospitalSeoul, Korea, Republic Of, 03080 Clinical Trial Center, Severance Hospital, Yonsei University Health System (Drug Shipment Only)Seoul, Korea, Republic Of, 03722 Severance Hospital, Yonsei University Health SystemSeoul, Korea, Republic Of, 03722 Department Of Pharmacy, Samsung Medical Center (Drug Shipment Only)Seoul, Korea, Republic Of, 06351 Samsung Medical CenterSeoul, Korea, Republic Of, 06351 The Catholic University Of Korea Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591 The Catholic University Of KoreaSeoul, Korea, Republic Of, 06591|Yoshida-Gun, Fukui, Japan, 910-1193|Maebashi, Gunma, Japan, 371-8511|Kobe-Shi, Hyogo, Japan, 650-0017|Yokohama, Kanagawa, Japan, 232-0024|Sendai, Miyagi, Japan, 980-8574|Osaka-City, Osaka, Japan, 545-8586 Kindai University HospitalOsaka-Sayama, Osaka, Japan, 589-8511|Sunto-Gun, Shizuoka, Japan, 411-8777|Tachikawa, Tokyo, Japan, 190-0014|Gdansk, Poland, 80-952|Craiova, Dolj, Romania, 200143 Russian Federation Sbhi Cch No. 40 Hd MoscowMoscow, Russian Federation, 129301 State Budgetary Healthcare Institution Of MoscowMoscow, Russian Federation, 129301 State Budgetary Institution Of Ryazan Region 'Regional Clinical Hospital' (Sbi Rr Rch)Ryazan, Russian Federation, 390039 Drug Shipment Address:Saint Petersburg, Russian Federation, 191024 Fsbi Russrhti Fmba Of|Barcelona, Spain, 08003 Hospital De La Santa Creu I Sant PauBarcelona, Spain, 08025 Hospital Universitario Ramon Y CajalMadrid, Spain, 28034 Hospital Universitario Virgen Del RocioSevilla, Spain, 41013 Hospital Universitari I Politecnic La FeValencia, Spain, 46026 Taiwan Department Of Clinical Trial Pharmacy, Taipei Veterans General HospitalTaipei, Taiwan, 11217 Taipei Veterans General HospitalTaipei, Taiwan, 11217 Division Of Pharmacy, Koo Foundation Sun Yat-Sen Cancer CenterTaipei, Taiwan, 112 Koo Foundation Sun Yat-Sen Cancer CenterTaipei, Taiwan, 112 Chang Gung Memorial Hospital-Linkou BranchTaoyuan City, Taiwan, 333 Chemotherapy Pharmacy, Chang Gung Memorial Hospital-Linkou BranchTaoyuan City, Taiwan, 333|Orange, California, United States, 92868-3201 Uc Irvine Medical CenterOrange, California, United States, 92868-3201 Ucsf Helen Diller Family Comprehensive Cancer CenterSan Francisco, California, United States, 94143 University Of California, San Francisco Medical CenterSan Francisco, California, United States, 94143 University Of California, San FranciscoSan Francisco, California, United States, 94143|Kansas City, Missouri, United States, 64132|Lake Success, New York, United States, 11042 North Shore University HospitalManhasset, New York, United States, 11030 Long Island Jewish Medical CenterNew Hyde Park, New York, United States, 11040|Cleveland, Ohio, United States, 44106 Cleveland Clinic FoundationCleveland, Ohio, United States, 44195|Nashville, Tennessee, United States, 37203|San Antonio, Texas, United States, 78229 Methodist Healthcare System Of San AntonioSan Antonio, Texas, United States, 78229 Methodist Hospital Investigational PharmacySan Antonio, Texas, United States, 78229|Seattle, Washington, United States, 98104 Swedish Investigational Drug Services PharmacySeattle, Washington, United States, 98104 Swedish Medical CenterSeattle, Washington, United States, 98122","California|Missouri|New York|Ohio|Tennessee|Texas|Washington","Czechia|Japan|Poland|Romania|Spain|United States","Interni Hematologicka A Onkologicka Klinika, Fakultni Nemocnice Brno|Aichi Japanese Red Cross Nagoya Daini Hospital|Akita University Hospital|Fukui University Of Fukui Hospital|Gunma Gunma University Hospital|Hyogo Kobe University Hospital|Kanagawa Yokohama City University Medical Center|Miyagi Tohoku University Hospital|Osaka Osaka City University Hospital|Shizuoka Shizuoka Cancer Center|Tokyo National Hospital Organization Disaster Medical Center|Klinika Hematologii I Transplantologii Uniwersyteckie Centrum Kliniczne|Dolj Spitalul Clinic Municipal Filantropia Craiova, Sectia Clinica Hematologie|Hospital Del Mar|Uc Irvine Health - Chao Family Comprehensive Cancer Center|Midamerica Division, Inc., C/O Research Medical Center|Northwell Health Monter Cancer Center|Taussig Cancer Center Investigational Pharmacy|The Sarah Cannon Research Institute|Blood Cancer And Stem Cell Transplant Clinic|Swedish Cancer Institute",{"$nulls":3},"Pfizer CT.gov Call Center","2018-09-07","2020-05-25T16:39:29.175","2020-05-26T17:10:42.972","NCT03416179"]
["5ecbf4c111702c1b1b916bc0","NCT03416179","2018-09-18","Pfizer","PFE","Recruiting","A Study Evaluating Intensive Chemotherapy With or Without Glasdegib or Azacitidine With or Without Glasdegib In Patients With Previously Untreated Acute Myeloid Leukemia (BRIGHT AML1019)","Glasdegib|Cytarabine|Daunorubicin|Azacitidine","Hh Inhibitor|DNA Polymerase Inhibitor|Nucleic Acid Synthesis Inhibitor|TOP2 Inhibitor|DNA Mtase Inhibitor","Yes","['Glasdegib']","Unknown",null,"Phase 3",4,720,"Anticipated","2018-04-20","2021-06-13","OS","Overall Survival",{"$nulls":3},"Glasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).\n\nGlasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).","Two separate registration trials conducted under one protocol number are proposed to adequately and independently evaluate the addition of glasdegib in intensive and non-intensive chemotherapy populations. Each study will have an experimental treatment arm and a placebo arm. Endpoints are the same for each study except where specifically indicated.\n\nAssignment to the Intensive Study or the Non-Intensive Study will be made by the Investigator based on the 2017 European LeukemiaNet (ELN) recommendations.\n\nStudy B1371019 is a randomized (1:1), double-blind, multi-center, placebo controlled study of chemotherapy in combination with glasdegib versus chemotherapy in combination with placebo in adult patients with previously untreated AML.\n\nGlasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).\n\nGlasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).","A RANDOMIZED (1:1), DOUBLE-BLIND, MULTI-CENTER, PLACEBO CONTROLLED STUDY EVALUATING INTENSIVE CHEMOTHERAPY WITH OR WITHOUT GLASDEGIB (PF-04449913) OR AZACITIDINE (AZA) WITH OR WITHOUT GLASDEGIB IN PATIENTS WITH PREVIOUSLY UNTREATED ACUTE MYELOID LEUKEMIA","B1371019","Leukemia, Myeloid, Acute","Acute Leukemia|Acute Myeloid Leukemia|Myeloid Leukemia|Leukemia","Oncology Hematological","Oncology","Experimental|Placebo Comparator","Arm A (Intensive Study)|Arm B (Intensive Study)|Arm A (Non-intensive study)|Arm B (Non-intensive study)","Glasdegib + '7+3' Induction(s)|Placebo + '7+3' Induction(s)|Glasdegib + azacitidine|Placebo + azacitidine","Drug|Procedure","glasdegib|daunorubicin + cytarabine|cytarabine|HSCT|Placebo|azacitidine","Daily Glasdegib (100 mg, PO), beginning on Day 1 and is to continue up to 2 years post randomization.\n\nFollowing consolidation therapy, glasdegib or placebo will be administered daily for up to 2 years after randomization or until they have minimal residual disease (MRD) negative disease, whichever comes first.\n\nDaily Glasdegib (100 mg, PO) or matching placebo will continue throughout Induction(s) and Consolidation therapies regardless of dose modifications/delays in the chemotherapy.|Consolidation with single agent cytarabine 3 g/m2 IV for adults <60 years and 1 g/m2 for adults 60 years over 3 BID on Days 1, 3, and 5, every 28 days for up to 4 cycles or alternative single agent cytarabine consolidation schedules may be used per local prescribing information.|If required, and done per standard of care post Induction(s).|Azacitidine (75 mg/m2, SC or IV) daily for 7 days, in 28 day cycles for as long as they do not meet the criteria for disease progression, unacceptable toxicity, consent withdrawal, or death.|Matching placebo (PO) is to be administered by mouth daily beginning on Day 1 of chemotherapy and will continue if subjects demonstrate reasonable evidence of clinical benefit and do not meet the criteria for progression regardless of any delays/modifications in the chemotherapy treatment. Subjects will continue placebo until disease progression, unacceptable toxicity, consent withdrawal, or death, whichever comes first.","PF-04449913","Arm A (Intensive Study)|Arm B (Intensive Study)|Arm A (Non-intensive study)|Arm B (Non-intensive study)","\n\nSubjects must meet all of the following inclusion criteria to be eligible for enrollment into the Intensive and Non Intensive study (unless where indicated):\n\n 1.  Subjects with untreated AML according to the World Health Organization (WHO) 2016 Classification2, including those with: * AML arising from MDS or another antecedent hematologic disease (AHD).\n      * AML after previous cytotoxic therapy or radiation (secondary AML).\n     \n     \n 2.  18 years of age (In Japan, 20 years of age).\n 3.  Adequate Organ Function as defined by the following: * Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) 3 x upper limit of normal (ULN), excluding subjects with liver function abnormalities due to underlying malignancy.\n      * Total serum bilirubin 2 x ULN (except subjects with documented Gilbert's syndrome).\n      * Estimated creatinine clearance 30 mL/min as calculated using the standard method for the institution.\n     \n     \n 4.  QTc interval 470 msec using the Fridericia correction (QTcF).\n 5.  All anti cancer treatments (unless specified) should be discontinued 2 weeks from study entry, for example: targeted chemotherapy, radiotherapy, investigational agents, hormones, anagrelide or cytokines. * For control of rapidly progressing leukemia, all trans retinoic acid (ATRA), hydroxyurea, and/or leukopheresis may be used before and for up to 1 week after the first dose of glasdegib.\n     \n     \n 6.  Serum or urine pregnancy test (for female subjects of childbearing potential) with a minimum sensitivity of 25 IU/L or equivalent units of human chorionic gonadotropin (hCG) negative at screening.\n 7.  Male and female subjects of childbearing potential and at risk for pregnancy must agree to use at least one highly effective method of contraception throughout the study and for 180 days after the last dose of azacitidine, cytarabine, or daunorubicin; and the last dose of glasdegib or placebo, whichever occurs later.\n 8.  Female subjects of non childbearing potential must meet at least 1 of the following criteria: 1. Have undergone a documented hysterectomy and/or bilateral oophorectomy;\n      2. Have medically confirmed ovarian failure; or\n      3. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; status may be confirmed by having a serum follicle stimulating hormone (FSH) level confirming the postmenopausal state.\n     \n     All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential.\n     \n     \n 9.  Consent to a saliva sample collection for a germline comparator, unless prohibited by local regulations or ethics committee (EC) decision.\n 10. Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.\n 11. Subjects who are willing and able to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures (including bone marrow [BM] assessments).\n\n","\n\nSubjects with any of the following characteristics/conditions will not be included in the study:\n\n 1.  Acute Promyelocytic Leukemia (APL) and APLwith PML RARA, subjects (WHO 2016 classification).\n 2.  AML with BCR ABL1 or t(9;22)(q34;q11.2) as a sole abnormality. * Complex genetics may include t(9;22) cytogenetic translocation.\n     \n     \n 3.  Subjects with known active CNS leukemia.\n 4.  Participation in other clinical studies involving other investigational drug(s) (Phases 1 4) within 4 weeks prior study entry and/or during study participation.\n 5.  Subjects known to be refractory to platelet or packed red cell transfusions per Institutional Guidelines, or a patient who refuses blood product support.\n 6.  Subjects with another active malignancy on treatment with the exception of basal cell carcinoma, non melanoma skin cancer, cervical carcinoma in situ. Other prior or concurrent malignancies will be considered on a case by case basis.\n 7.  Any one of the following ongoing or in the previous 6 months: myocardial infarction, congenital long QT syndrome, Torsades de pointes, symptomatic arrhythmias (including sustained ventricular tachyarrhythmia), right or left bundle branch block and bifascicular block, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (CHF New York Heart Association class III or IV), cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism; as well as bradycardia defined as <50 bpms.\n 8.  Subjects with an active, life threatening or clinically significant uncontrolled systemic infection not related to AML.\n 9.  Subjects with left ventricular ejection fraction (LVEF) <50% are excluded from the Intensive Chemotherapy Study only.\n 10. Cumulative anthracycline dose equivalent of 550 mg/m2 of daunorubicin for the Intensive Chemotherapy Study only.\n 11. Known malabsorption syndrome or other condition that may significantly impair absorption of study medication in the investigator's judgment (eg, gastrectomy, lap band, Crohn's disease) and inability or unwillingness to swallow tablets or capsules.\n 12. Current use or anticipated requirement for drugs that are known strong CYP3A4/5 inducers.\n 13. Concurrent administration of herbal preparations.\n 14. Major surgery or radiation within 4 weeks of starting study treatment.\n 15. Documented or suspected hypersensitivity to any one of the following: * For subjects assigned to intensive chemotherapy, documented or suspected hypersensitivity to cytarabine (not including drug fever or exanthema, including known cerebellar side effects) or daunorubicin.\n      * For subjects assigned to non intensive chemotherapy, documented or suspected hypersensitivity to azacitidine or mannitol.\n     \n     \n 16. Known active drug or alcohol abuse.\n 17. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.\n 18. Pregnant females or breastfeeding female subjects.\n 19. Known recent or active suicidal ideation or behavior.\n 20. Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.","FSH",null,"Protein","Ovary","Actual","2018-01-31","Actual","Anticipated","2025-07-22","Anticipated","2018-09-01","2017-12-21","2018-01-23","2018-09-16","Yes","glasdegib;\nuntreated;\nHedgehog Inhibitor","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"All",null,"No","Yes\nInformation relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests",null,"URL: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1371019&StudyName=A+Randomized+%281%3A1%29%2C+Double+Blind%2C+Multi+Center%2C+Placebo+Controlled+Study+Evaluating+Intensive+Chemotherapy+With+Or+Without+Glasdegib+%28pf+04449913%29+Or+Azacitidine+%28aza%29+With+Or+Without+Glasdegib+In+Patients+With+Previously+Untreated+Acute+Myeloid+Leukemia [https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1371019&StudyName=A+Randomized+%281%3A1%29%2C+Double+Blind%2C+Multi+Center%2C+Placebo+Controlled+Study+Evaluating+Intensive+Chemotherapy+With+Or+Without+Glasdegib+%28pf+04449913%29+Or+Azacitidine+%28aza%29+With+Or+Without+Glasdegib+In+Patients+With+Previously+Untreated+Acute+Myeloid+Leukemia] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To obtain contact information for a study center near you, click here.",null,"Yes","No",{"$nulls":17},"2017-002822-19|BRIGHT|BRIGHT AML1019","EudraCT Number|Alias Study Number","Overall survival","5 years after last subject randomized",null,"Fatigue score measured by the MD Anderson Symptom Inventory (MDASI)-AML/MDS questionnaire|Rate of Complete Remission (CR) (including CR with minimal residual disease (MRD)-negative as assessed by multiparametric flow cytometry)|Duration of response (defined as CR [includes CR-MRD negative]/CRi or CR/CRh as appropriate)|Time to response (CR[includes CR-MRD negative)]/CR with partial hematologic rcovery (CRh) as appropriate)|Event-free Survival|Patient Reported Outcomes (PROs) as measured by the M.D. Anderson Symptom Inventory AML/MDS Module (MDASI-AML/MDS)|Adverse events as graded by NCI CTCAE v4.03|Laboratory abnormalities as graded by NCI CTCAE v4.03|For the intensive study, the plasma trough concentration (Ctrough) will be analyzed|QTc interval|PROs as measured by Patient Global Impression of Change (PGIC)|Patient Reported Outcomes (PROs) as measured by EuroQoL 5 Dimension questionnaire 5-Level version (EQ-5D-5L)|Patient Reported Outcomes (PROs) as measured by Patient Global Impression of Symptoms (PGIS)|Complete Remission with incomplete hematologic recovery (CRi)|Rate of morphological leukemia-free state (MLFS)|Rate of Partial Remission (PR)|Rate of Complete Remission with partial hematological recovery (CRh) for the Non-intensive study only only|Minimum Observed Plasma Trough Concentratrion of glasdegib in the Intensive Study|Minimum Observed Plasma Trough Concentration of glasdegib in the Non-intensive study","Scale is from 0-10 where 0 is not present and 10 is as bad as you can image.|Response as defined by the 2017 European LeukemiaNet (ELN) recommendations.|5 years after last subject randomized, consent withdrawal, or death|Measurement Scale from 0-10.|PK samples taken on Induction(s) Day 1 (1 and 4 hours post induction); Induction(s) Day 10 (pre-dose, 1 and 4 hours post dose); Day 1 of each Consolidation cycle (pre-dose, 1 and 4 hours post dose)|One question asking for description of leukemia symptoms.|Series of questions that ask for information that best describes health.|One question asking for information regarding leukemia symptoms.|Its the minimum trough concentration in plasma of glasdegib following multiple daily dosing to steady state.|It is the minimum trough concentration in plasma of glasdegib following multiple daily dosing to steady state.","5 years after last subject randomized, consent withdrawal, or death|2 years after last dose of study therapy|5 years after last patient randomized, withdrawal, or death|5 years after last subject randomized, withdrawal, or death|Day 10 of Induction Cycle and Day 1 of each Consolidation Cycle|Cycle 1 Day 15 and Cycles 2 and 3 on Day 1","ClinicalTrials.gov_Inquiries@pfizer.com","Pfizer CT.gov Call Center","1-800-718-1021","Brno, Czechia, 625 00 Nemocnicni LekarnaBrno, Czechia, 625 00|Nagoya, Aichi, Japan, 466-8650|Akita, Japan, 010-8543 Kyushu University HospitalFukuoka, Japan, 812-8582 National Hospital Organization Kumamoto Medical CenterKumamoto, Japan, 860-0008 Nagasaki University HospitalNagasaki, Japan, 852-8501 Tokyo Medical University HospitalTokyo, Japan, 160-0023 Korea, Republic Of, Jeollabuk-Do Chonbuk National University HospitalJeonju-Si, Jeollabuk-Do, Korea, Republic Of, 54907 Korea, Republic Of, Jeollanam-Do Chonnam National University Hwasun HospitalHwasun-Gun, Jeollanam-Do, Korea, Republic Of, 58128 Korea, Republic Of Department Of Pharmacy, Inje University Busan Paik HospitalBusan, Korea, Republic Of, 47392 Inje University Busan Paik HospitalBusan, Korea, Republic Of, 47392 Clinical Trial Pharmacy, Keimyung University Dongsan HospitalDaegu, Korea, Republic Of, 41931 Keimyung University Dongsan HospitalDaegu, Korea, Republic Of, 41931 Gachon University Gil Medical CenterIncheon, Korea, Republic Of, 21565 Seoul National University HospitalSeoul, Korea, Republic Of, 03080 Clinical Trial Center, Severance Hospital, Yonsei University Health System (Drug Shipment Only)Seoul, Korea, Republic Of, 03722 Severance Hospital, Yonsei University Health SystemSeoul, Korea, Republic Of, 03722 Department Of Pharmacy, Samsung Medical Center (Drug Shipment Only)Seoul, Korea, Republic Of, 06351 Samsung Medical CenterSeoul, Korea, Republic Of, 06351 The Catholic University Of Korea Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591 The Catholic University Of KoreaSeoul, Korea, Republic Of, 06591|Yoshida-Gun, Fukui, Japan, 910-1193|Maebashi, Gunma, Japan, 371-8511|Kobe-Shi, Hyogo, Japan, 650-0017|Yokohama, Kanagawa, Japan, 232-0024|Sendai, Miyagi, Japan, 980-8574|Osaka-City, Osaka, Japan, 545-8586 Kindai University HospitalOsaka-Sayama, Osaka, Japan, 589-8511|Sunto-Gun, Shizuoka, Japan, 411-8777|Tachikawa, Tokyo, Japan, 190-0014|Gdansk, Poland, 80-952|Craiova, Dolj, Romania, 200143 Russian Federation Sbhi Cch No. 40 Hd MoscowMoscow, Russian Federation, 129301 State Budgetary Healthcare Institution Of MoscowMoscow, Russian Federation, 129301 State Budgetary Institution Of Ryazan Region 'Regional Clinical Hospital' (Sbi Rr Rch)Ryazan, Russian Federation, 390039 Drug Shipment Address:Saint Petersburg, Russian Federation, 191024 Fsbi Russrhti Fmba Of|Barcelona, Spain, 08003 Hospital De La Santa Creu I Sant PauBarcelona, Spain, 08025 Hospital Universitario Arnau De VilanovaLleida, Spain, 25198 Hospital General Universitario Gregorio MaranonMadrid, Spain, 28007 Hospital Universitario Ramon Y CajalMadrid, Spain, 28034 Hospital Universitario Virgen Del RocioSevilla, Spain, 41013 Hospital Universitari I Politecnic La FeValencia, Spain, 46026 Taiwan Department Of Clinical Trial Pharmacy, Taipei Veterans General HospitalTaipei, Taiwan, 11217 Taipei Veterans General HospitalTaipei, Taiwan, 11217 Division Of Pharmacy, Koo Foundation Sun Yat-Sen Cancer CenterTaipei, Taiwan, 112 Koo Foundation Sun Yat-Sen Cancer CenterTaipei, Taiwan, 112 Chang Gung Memorial Hospital-Linkou BranchTaoyuan City, Taiwan, 333 Chemotherapy Pharmacy, Chang Gung Memorial Hospital-Linkou BranchTaoyuan City, Taiwan, 333|Los Angeles, California, United States, 90095 Ucla Department Of MedicineLos Angeles, California, United States, 90095 Ucla Hematology/Oncology ClinicLos Angeles, California, United States, 90095 Ucla Ronald Reagan Medical CenterLos Angeles, California, United States, 90095 Uc Irvine Health - Chao Family Comprehensive Cancer CenterOrange, California, United States, 92868-3201 Uc Irvine Medical CenterOrange, California, United States, 92868-3201 Ucsf Helen Diller Family Comprehensive Cancer CenterSan Francisco, California, United States, 94143 University Of California, San Francisco Medical CenterSan Francisco, California, United States, 94143 University Of California, San FranciscoSan Francisco, California, United States, 94143|Kansas City, Missouri, United States, 64132|Lake Success, New York, United States, 11042 North Shore University HospitalManhasset, New York, United States, 11030 Long Island Jewish Medical CenterNew Hyde Park, New York, United States, 11040|Cleveland, Ohio, United States, 44106 University Hospitals Cleveland Medical CenterCleveland, Ohio, United States, 44106 Cleveland Clinic FoundationCleveland, Ohio, United States, 44195|Nashville, Tennessee, United States, 37203|San Antonio, Texas, United States, 78229 Methodist Healthcare System Of San AntonioSan Antonio, Texas, United States, 78229 Methodist Hospital Investigational PharmacySan Antonio, Texas, United States, 78229|Seattle, Washington, United States, 98104 Swedish Investigational Drug Services PharmacySeattle, Washington, United States, 98104 Swedish Medical CenterSeattle, Washington, United States, 98122","California|Missouri|New York|Ohio|Tennessee|Texas|Washington","Czechia|Japan|Poland|Romania|Spain|United States","Interni Hematologicka A Onkologicka Klinika, Fakultni Nemocnice Brno|Aichi Japanese Red Cross Nagoya Daini Hospital|Akita University Hospital|Fukui University Of Fukui Hospital|Gunma Gunma University Hospital|Hyogo Kobe University Hospital|Kanagawa Yokohama City University Medical Center|Miyagi Tohoku University Hospital|Osaka Osaka City University Hospital|Shizuoka Shizuoka Cancer Center|Tokyo National Hospital Organization Disaster Medical Center|Klinika Hematologii I Transplantologii Uniwersyteckie Centrum Kliniczne|Dolj Spitalul Clinic Municipal Filantropia Craiova, Sectia Clinica Hematologie|Hospital Del Mar|Rrmc - Ucla|Midamerica Division, Inc., C/O Research Medical Center|Northwell Health Monter Cancer Center|Taussig Cancer Center Investigational Pharmacy|The Sarah Cannon Research Institute|Blood Cancer And Stem Cell Transplant Clinic|Swedish Cancer Institute",{"$nulls":3},"Pfizer CT.gov Call Center","2018-09-16","2020-05-25T16:39:29.257","2020-05-26T17:10:42.972","NCT03416179"]
["5ecbf4c1307e3d1b1f8d9e45","NCT03416179","2018-10-02","Pfizer","PFE","Recruiting","A Study Evaluating Intensive Chemotherapy With or Without Glasdegib or Azacitidine With or Without Glasdegib In Patients With Previously Untreated Acute Myeloid Leukemia (BRIGHT AML1019)","Glasdegib|Cytarabine|Daunorubicin|Azacitidine","Hh Inhibitor|DNA Polymerase Inhibitor|Nucleic Acid Synthesis Inhibitor|TOP2 Inhibitor|DNA Mtase Inhibitor","Yes","['Glasdegib']","Unknown",null,"Phase 3",4,720,"Anticipated","2018-04-20","2021-06-13","OS","Overall Survival",{"$nulls":3},"Glasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).\n\nGlasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).","Two separate registration trials conducted under one protocol number are proposed to adequately and independently evaluate the addition of glasdegib in intensive and non-intensive chemotherapy populations. Each study will have an experimental treatment arm and a placebo arm. Endpoints are the same for each study except where specifically indicated.\n\nAssignment to the Intensive Study or the Non-Intensive Study will be made by the Investigator based on the 2017 European LeukemiaNet (ELN) recommendations.\n\nStudy B1371019 is a randomized (1:1), double-blind, multi-center, placebo controlled study of chemotherapy in combination with glasdegib versus chemotherapy in combination with placebo in adult patients with previously untreated AML.\n\nGlasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).\n\nGlasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).","A RANDOMIZED (1:1), DOUBLE-BLIND, MULTI-CENTER, PLACEBO CONTROLLED STUDY EVALUATING INTENSIVE CHEMOTHERAPY WITH OR WITHOUT GLASDEGIB (PF-04449913) OR AZACITIDINE (AZA) WITH OR WITHOUT GLASDEGIB IN PATIENTS WITH PREVIOUSLY UNTREATED ACUTE MYELOID LEUKEMIA","B1371019","Leukemia, Myeloid, Acute","Acute Leukemia|Acute Myeloid Leukemia|Myeloid Leukemia|Leukemia","Oncology Hematological","Oncology","Experimental|Placebo Comparator","Arm A (Intensive Study)|Arm B (Intensive Study)|Arm A (Non-intensive study)|Arm B (Non-intensive study)","Glasdegib + '7+3' Induction(s)|Placebo + '7+3' Induction(s)|Glasdegib + azacitidine|Placebo + azacitidine","Drug|Procedure","glasdegib|daunorubicin + cytarabine|cytarabine|HSCT|Placebo|azacitidine","Daily Glasdegib (100 mg, PO), beginning on Day 1 and is to continue up to 2 years post randomization.\n\nFollowing consolidation therapy, glasdegib or placebo will be administered daily for up to 2 years after randomization or until they have minimal residual disease (MRD) negative disease, whichever comes first.\n\nDaily Glasdegib (100 mg, PO) or matching placebo will continue throughout Induction(s) and Consolidation therapies regardless of dose modifications/delays in the chemotherapy.|Consolidation with single agent cytarabine 3 g/m2 IV for adults <60 years and 1 g/m2 for adults 60 years over 3 BID on Days 1, 3, and 5, every 28 days for up to 4 cycles or alternative single agent cytarabine consolidation schedules may be used per local prescribing information.|If required, and done per standard of care post Induction(s).|Azacitidine (75 mg/m2, SC or IV) daily for 7 days, in 28 day cycles for as long as they do not meet the criteria for disease progression, unacceptable toxicity, consent withdrawal, or death.|Matching placebo (PO) is to be administered by mouth daily beginning on Day 1 of chemotherapy and will continue if subjects demonstrate reasonable evidence of clinical benefit and do not meet the criteria for progression regardless of any delays/modifications in the chemotherapy treatment. Subjects will continue placebo until disease progression, unacceptable toxicity, consent withdrawal, or death, whichever comes first.","PF-04449913","Arm A (Intensive Study)|Arm B (Intensive Study)|Arm A (Non-intensive study)|Arm B (Non-intensive study)","\n\nSubjects must meet all of the following inclusion criteria to be eligible for enrollment into the Intensive and Non Intensive study (unless where indicated):\n\n 1.  Subjects with untreated AML according to the World Health Organization (WHO) 2016 Classification2, including those with: * AML arising from MDS or another antecedent hematologic disease (AHD).\n      * AML after previous cytotoxic therapy or radiation (secondary AML).\n     \n     \n 2.  18 years of age (In Japan, 20 years of age).\n 3.  Adequate Organ Function as defined by the following: * Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) 3 x upper limit of normal (ULN), excluding subjects with liver function abnormalities due to underlying malignancy.\n      * Total serum bilirubin 2 x ULN (except subjects with documented Gilbert's syndrome).\n      * Estimated creatinine clearance 30 mL/min as calculated using the standard method for the institution.\n     \n     \n 4.  QTc interval 470 msec using the Fridericia correction (QTcF).\n 5.  All anti cancer treatments (unless specified) should be discontinued 2 weeks from study entry, for example: targeted chemotherapy, radiotherapy, investigational agents, hormones, anagrelide or cytokines. * For control of rapidly progressing leukemia, all trans retinoic acid (ATRA), hydroxyurea, and/or leukopheresis may be used before and for up to 1 week after the first dose of glasdegib.\n     \n     \n 6.  Serum or urine pregnancy test (for female subjects of childbearing potential) with a minimum sensitivity of 25 IU/L or equivalent units of human chorionic gonadotropin (hCG) negative at screening.\n 7.  Male and female subjects of childbearing potential and at risk for pregnancy must agree to use at least one highly effective method of contraception throughout the study and for 180 days after the last dose of azacitidine, cytarabine, or daunorubicin; and the last dose of glasdegib or placebo, whichever occurs later.\n 8.  Female subjects of non childbearing potential must meet at least 1 of the following criteria: 1. Have undergone a documented hysterectomy and/or bilateral oophorectomy;\n      2. Have medically confirmed ovarian failure; or\n      3. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; status may be confirmed by having a serum follicle stimulating hormone (FSH) level confirming the postmenopausal state.\n     \n     All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential.\n     \n     \n 9.  Consent to a saliva sample collection for a germline comparator, unless prohibited by local regulations or ethics committee (EC) decision.\n 10. Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.\n 11. Subjects who are willing and able to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures (including bone marrow [BM] assessments).\n\n","\n\nSubjects with any of the following characteristics/conditions will not be included in the study:\n\n 1.  Acute Promyelocytic Leukemia (APL) and APLwith PML RARA, subjects (WHO 2016 classification).\n 2.  AML with BCR ABL1 or t(9;22)(q34;q11.2) as a sole abnormality. * Complex genetics may include t(9;22) cytogenetic translocation.\n     \n     \n 3.  Subjects with known active CNS leukemia.\n 4.  Participation in other clinical studies involving other investigational drug(s) (Phases 1 4) within 4 weeks prior study entry and/or during study participation.\n 5.  Subjects known to be refractory to platelet or packed red cell transfusions per Institutional Guidelines, or a patient who refuses blood product support.\n 6.  Subjects with another active malignancy on treatment with the exception of basal cell carcinoma, non melanoma skin cancer, cervical carcinoma in situ. Other prior or concurrent malignancies will be considered on a case by case basis.\n 7.  Any one of the following ongoing or in the previous 6 months: myocardial infarction, congenital long QT syndrome, Torsades de pointes, symptomatic arrhythmias (including sustained ventricular tachyarrhythmia), right or left bundle branch block and bifascicular block, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (CHF New York Heart Association class III or IV), cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism; as well as bradycardia defined as <50 bpms.\n 8.  Subjects with an active, life threatening or clinically significant uncontrolled systemic infection not related to AML.\n 9.  Subjects with left ventricular ejection fraction (LVEF) <50% are excluded from the Intensive Chemotherapy Study only.\n 10. Cumulative anthracycline dose equivalent of 550 mg/m2 of daunorubicin for the Intensive Chemotherapy Study only.\n 11. Known malabsorption syndrome or other condition that may significantly impair absorption of study medication in the investigator's judgment (eg, gastrectomy, lap band, Crohn's disease) and inability or unwillingness to swallow tablets or capsules.\n 12. Current use or anticipated requirement for drugs that are known strong CYP3A4/5 inducers.\n 13. Concurrent administration of herbal preparations.\n 14. Major surgery or radiation within 4 weeks of starting study treatment.\n 15. Documented or suspected hypersensitivity to any one of the following: * For subjects assigned to intensive chemotherapy, documented or suspected hypersensitivity to cytarabine (not including drug fever or exanthema, including known cerebellar side effects) or daunorubicin.\n      * For subjects assigned to non intensive chemotherapy, documented or suspected hypersensitivity to azacitidine or mannitol.\n     \n     \n 16. Known active drug or alcohol abuse.\n 17. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.\n 18. Pregnant females or breastfeeding female subjects.\n 19. Known recent or active suicidal ideation or behavior.\n 20. Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.","FSH",null,"Protein","Ovary","Actual","2018-01-31","Actual","Anticipated","2025-07-22","Anticipated","2018-10-01","2017-12-21","2018-01-23","2018-10-01","Yes","glasdegib;\nuntreated;\nHedgehog Inhibitor","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"All",null,"No","Yes\nInformation relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests",null,"URL: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1371019&StudyName=A+Randomized+%281%3A1%29%2C+Double+Blind%2C+Multi+Center%2C+Placebo+Controlled+Study+Evaluating+Intensive+Chemotherapy+With+Or+Without+Glasdegib+%28pf+04449913%29+Or+Azacitidine+%28aza%29+With+Or+Without+Glasdegib+In+Patients+With+Previously+Untreated+Acute+Myeloid+Leukemia [https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1371019&StudyName=A+Randomized+%281%3A1%29%2C+Double+Blind%2C+Multi+Center%2C+Placebo+Controlled+Study+Evaluating+Intensive+Chemotherapy+With+Or+Without+Glasdegib+%28pf+04449913%29+Or+Azacitidine+%28aza%29+With+Or+Without+Glasdegib+In+Patients+With+Previously+Untreated+Acute+Myeloid+Leukemia] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To obtain contact information for a study center near you, click here.",null,"Yes","No",{"$nulls":17},"2017-002822-19|BRIGHT|BRIGHT AML1019","EudraCT Number|Alias Study Number","Overall survival","5 years after last subject randomized",null,"Fatigue score measured by the MD Anderson Symptom Inventory (MDASI)-AML/MDS questionnaire|Rate of Complete Remission (CR) (including CR with minimal residual disease (MRD)-negative as assessed by multiparametric flow cytometry)|Duration of response (defined as CR [includes CR-MRD negative]/CRi or CR/CRh as appropriate)|Time to response (CR[includes CR-MRD negative)]/CR with partial hematologic rcovery (CRh) as appropriate)|Event-free Survival|Patient Reported Outcomes (PROs) as measured by the M.D. Anderson Symptom Inventory AML/MDS Module (MDASI-AML/MDS)|Adverse events as graded by NCI CTCAE v4.03|Laboratory abnormalities as graded by NCI CTCAE v4.03|For the intensive study, the plasma trough concentration (Ctrough) will be analyzed|QTc interval|PROs as measured by Patient Global Impression of Change (PGIC)|Patient Reported Outcomes (PROs) as measured by EuroQoL 5 Dimension questionnaire 5-Level version (EQ-5D-5L)|Patient Reported Outcomes (PROs) as measured by Patient Global Impression of Symptoms (PGIS)|Complete Remission with incomplete hematologic recovery (CRi)|Rate of morphological leukemia-free state (MLFS)|Rate of Partial Remission (PR)|Rate of Complete Remission with partial hematological recovery (CRh) for the Non-intensive study only only|Minimum Observed Plasma Trough Concentratrion of glasdegib in the Intensive Study|Minimum Observed Plasma Trough Concentration of glasdegib in the Non-intensive study","Scale is from 0-10 where 0 is not present and 10 is as bad as you can image.|Response as defined by the 2017 European LeukemiaNet (ELN) recommendations.|5 years after last subject randomized, consent withdrawal, or death|Measurement Scale from 0-10.|PK samples taken on Induction(s) Day 1 (1 and 4 hours post induction); Induction(s) Day 10 (pre-dose, 1 and 4 hours post dose); Day 1 of each Consolidation cycle (pre-dose, 1 and 4 hours post dose)|One question asking for description of leukemia symptoms.|Series of questions that ask for information that best describes health.|One question asking for information regarding leukemia symptoms.|Its the minimum trough concentration in plasma of glasdegib following multiple daily dosing to steady state.|It is the minimum trough concentration in plasma of glasdegib following multiple daily dosing to steady state.","5 years after last subject randomized, consent withdrawal, or death|2 years after last dose of study therapy|5 years after last patient randomized, withdrawal, or death|5 years after last subject randomized, withdrawal, or death|Day 10 of Induction Cycle and Day 1 of each Consolidation Cycle|Cycle 1 Day 15 and Cycles 2 and 3 on Day 1","ClinicalTrials.gov_Inquiries@pfizer.com","Pfizer CT.gov Call Center","1-800-718-1021","Brno, Czechia, 625 00 Nemocnicni LekarnaBrno, Czechia, 625 00|Nagoya, Aichi, Japan, 466-8650|Akita, Japan, 010-8543 Kyushu University HospitalFukuoka, Japan, 812-8582 National Hospital Organization Kumamoto Medical CenterKumamoto, Japan, 860-0008 Nagasaki University HospitalNagasaki, Japan, 852-8501 Tokyo Medical University HospitalTokyo, Japan, 160-0023 Korea, Republic Of, Jeollabuk-Do Chonbuk National University HospitalJeonju-Si, Jeollabuk-Do, Korea, Republic Of, 54907 Korea, Republic Of, Jeollanam-Do Chonnam National University Hwasun HospitalHwasun-Gun, Jeollanam-Do, Korea, Republic Of, 58128 Korea, Republic Of Department Of Pharmacy, Inje University Busan Paik HospitalBusan, Korea, Republic Of, 47392 Inje University Busan Paik HospitalBusan, Korea, Republic Of, 47392 Clinical Trial Pharmacy, Keimyung University Dongsan HospitalDaegu, Korea, Republic Of, 41931 Keimyung University Dongsan HospitalDaegu, Korea, Republic Of, 41931 Gachon University Gil Medical CenterIncheon, Korea, Republic Of, 21565 Seoul National University HospitalSeoul, Korea, Republic Of, 03080 Clinical Trial Center, Severance Hospital, Yonsei University Health System (Drug Shipment Only)Seoul, Korea, Republic Of, 03722 Severance Hospital, Yonsei University Health SystemSeoul, Korea, Republic Of, 03722 Department Of Pharmacy, Samsung Medical Center (Drug Shipment Only)Seoul, Korea, Republic Of, 06351 Samsung Medical CenterSeoul, Korea, Republic Of, 06351 The Catholic University Of Korea Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591 The Catholic University Of KoreaSeoul, Korea, Republic Of, 06591|Yoshida-Gun, Fukui, Japan, 910-1193|Maebashi, Gunma, Japan, 371-8511|Kobe-Shi, Hyogo, Japan, 650-0017|Yokohama, Kanagawa, Japan, 232-0024|Sendai, Miyagi, Japan, 980-8574|Osaka-City, Osaka, Japan, 545-8586 Kindai University HospitalOsaka-Sayama, Osaka, Japan, 589-8511|Sunto-Gun, Shizuoka, Japan, 411-8777|Tachikawa, Tokyo, Japan, 190-0014|Gdansk, Poland, 80-952|Craiova, Dolj, Romania, 200143 Russian Federation Sbhi Cch No. 40 Hd MoscowMoscow, Russian Federation, 129301 State Budgetary Healthcare Institution Of MoscowMoscow, Russian Federation, 129301 State Budgetary Institution Of Ryazan Region 'Regional Clinical Hospital' (Sbi Rr Rch)Ryazan, Russian Federation, 390039 Drug Shipment Address:Saint Petersburg, Russian Federation, 191024 Fsbi Russrhti Fmba Of|Barcelona, Spain, 08003 Hospital De La Santa Creu I Sant PauBarcelona, Spain, 08025 Hospital Universitario Arnau De VilanovaLleida, Spain, 25198 Hospital General Universitario Gregorio MaranonMadrid, Spain, 28007 Hospital Universitario Ramon Y CajalMadrid, Spain, 28034 Hospital Universitario Virgen Del RocioSevilla, Spain, 41013 Hospital Universitari I Politecnic La FeValencia, Spain, 46026 Taiwan Department Of Clinical Trial Pharmacy, Taipei Veterans General HospitalTaipei, Taiwan, 11217 Taipei Veterans General HospitalTaipei, Taiwan, 11217 Division Of Pharmacy, Koo Foundation Sun Yat-Sen Cancer CenterTaipei, Taiwan, 112 Koo Foundation Sun Yat-Sen Cancer CenterTaipei, Taiwan, 112 Chang Gung Memorial Hospital-Linkou BranchTaoyuan City, Taiwan, 333 Chemotherapy Pharmacy, Chang Gung Memorial Hospital-Linkou BranchTaoyuan City, Taiwan, 333|Los Angeles, California, United States, 90095 Ucla Department Of MedicineLos Angeles, California, United States, 90095 Ucla Hematology/Oncology ClinicLos Angeles, California, United States, 90095 Ucla Ronald Reagan Medical CenterLos Angeles, California, United States, 90095 Uc Irvine Health - Chao Family Comprehensive Cancer CenterOrange, California, United States, 92868-3201 Uc Irvine Medical CenterOrange, California, United States, 92868-3201 Ucsf Helen Diller Family Comprehensive Cancer CenterSan Francisco, California, United States, 94143 University Of California, San Francisco Medical CenterSan Francisco, California, United States, 94143 University Of California, San FranciscoSan Francisco, California, United States, 94143|Kansas City, Missouri, United States, 64132|Lake Success, New York, United States, 11042 North Shore University HospitalManhasset, New York, United States, 11030 Long Island Jewish Medical CenterNew Hyde Park, New York, United States, 11040|Cleveland, Ohio, United States, 44106 University Hospitals Cleveland Medical CenterCleveland, Ohio, United States, 44106 Cleveland Clinic FoundationCleveland, Ohio, United States, 44195|Nashville, Tennessee, United States, 37203|San Antonio, Texas, United States, 78229 Methodist Healthcare System Of San AntonioSan Antonio, Texas, United States, 78229 Methodist Hospital Investigational PharmacySan Antonio, Texas, United States, 78229|Seattle, Washington, United States, 98104 Swedish Investigational Drug Services PharmacySeattle, Washington, United States, 98104 Swedish Medical CenterSeattle, Washington, United States, 98122","California|Missouri|New York|Ohio|Tennessee|Texas|Washington","Czechia|Japan|Poland|Romania|Spain|United States","Interni Hematologicka A Onkologicka Klinika, Fakultni Nemocnice Brno|Aichi Japanese Red Cross Nagoya Daini Hospital|Akita University Hospital|Fukui University Of Fukui Hospital|Gunma Gunma University Hospital|Hyogo Kobe University Hospital|Kanagawa Yokohama City University Medical Center|Miyagi Tohoku University Hospital|Osaka Osaka City University Hospital|Shizuoka Shizuoka Cancer Center|Tokyo National Hospital Organization Disaster Medical Center|Klinika Hematologii I Transplantologii Uniwersyteckie Centrum Kliniczne|Dolj Spitalul Clinic Municipal Filantropia Craiova, Sectia Clinica Hematologie|Hospital Del Mar|Rrmc - Ucla|Midamerica Division, Inc., C/O Research Medical Center|Northwell Health Monter Cancer Center|Taussig Cancer Center Investigational Pharmacy|The Sarah Cannon Research Institute|Blood Cancer And Stem Cell Transplant Clinic|Swedish Cancer Institute",{"$nulls":3},"Pfizer CT.gov Call Center","2018-10-01","2020-05-25T16:39:29.565","2020-05-26T17:10:42.972","NCT03416179"]
["5ecbf4c1fe30261b1a0483b4","NCT03416179","2018-10-29","Pfizer","PFE","Recruiting","A Study Evaluating Intensive Chemotherapy With or Without Glasdegib or Azacitidine With or Without Glasdegib In Patients With Previously Untreated Acute Myeloid Leukemia (BRIGHT AML1019)","Glasdegib|Cytarabine|Daunorubicin|Azacitidine","Hh Inhibitor|DNA Polymerase Inhibitor|Nucleic Acid Synthesis Inhibitor|TOP2 Inhibitor|DNA Mtase Inhibitor","Yes","['Glasdegib']","Unknown",null,"Phase 3",4,720,"Anticipated","2018-04-20","2021-06-13","OS","Overall Survival",{"$nulls":3},"Glasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).\n\nGlasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).","Two separate registration trials conducted under one protocol number are proposed to adequately and independently evaluate the addition of glasdegib in intensive and non-intensive chemotherapy populations. Each study will have an experimental treatment arm and a placebo arm. Endpoints are the same for each study except where specifically indicated.\n\nAssignment to the Intensive Study or the Non-Intensive Study will be made by the Investigator based on the 2017 European LeukemiaNet (ELN) recommendations.\n\nStudy B1371019 is a randomized (1:1), double-blind, multi-center, placebo controlled study of chemotherapy in combination with glasdegib versus chemotherapy in combination with placebo in adult patients with previously untreated AML.\n\nGlasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).\n\nGlasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).","A RANDOMIZED (1:1), DOUBLE-BLIND, MULTI-CENTER, PLACEBO CONTROLLED STUDY EVALUATING INTENSIVE CHEMOTHERAPY WITH OR WITHOUT GLASDEGIB (PF-04449913) OR AZACITIDINE (AZA) WITH OR WITHOUT GLASDEGIB IN PATIENTS WITH PREVIOUSLY UNTREATED ACUTE MYELOID LEUKEMIA","B1371019","Leukemia, Myeloid, Acute","Acute Leukemia|Acute Myeloid Leukemia|Myeloid Leukemia|Leukemia","Oncology Hematological","Oncology","Experimental|Placebo Comparator","Arm A (Intensive Study)|Arm B (Intensive Study)|Arm A (Non-intensive study)|Arm B (Non-intensive study)","Glasdegib + '7+3' Induction(s)|Placebo + '7+3' Induction(s)|Glasdegib + azacitidine|Placebo + azacitidine","Drug|Procedure","glasdegib|daunorubicin + cytarabine|cytarabine|HSCT|Placebo|azacitidine","Daily Glasdegib (100 mg, PO), beginning on Day 1 and is to continue up to 2 years post randomization.\n\nFollowing consolidation therapy, glasdegib or placebo will be administered daily for up to 2 years after randomization or until they have minimal residual disease (MRD) negative disease, whichever comes first.\n\nDaily Glasdegib (100 mg, PO) or matching placebo will continue throughout Induction(s) and Consolidation therapies regardless of dose modifications/delays in the chemotherapy.|Consolidation with single agent cytarabine 3 g/m2 IV for adults <60 years and 1 g/m2 for adults 60 years over 3 BID on Days 1, 3, and 5, every 28 days for up to 4 cycles or alternative single agent cytarabine consolidation schedules may be used per local prescribing information.|If required, and done per standard of care post Induction(s).|Azacitidine (75 mg/m2, SC or IV) daily for 7 days, in 28 day cycles for as long as they do not meet the criteria for disease progression, unacceptable toxicity, consent withdrawal, or death.|Matching placebo (PO) is to be administered by mouth daily beginning on Day 1 of chemotherapy and will continue if subjects demonstrate reasonable evidence of clinical benefit and do not meet the criteria for progression regardless of any delays/modifications in the chemotherapy treatment. Subjects will continue placebo until disease progression, unacceptable toxicity, consent withdrawal, or death, whichever comes first.","PF-04449913","Arm A (Intensive Study)|Arm B (Intensive Study)|Arm A (Non-intensive study)|Arm B (Non-intensive study)","\n\nSubjects must meet all of the following inclusion criteria to be eligible for enrollment into the Intensive and Non Intensive study (unless where indicated):\n\n 1.  Subjects with untreated AML according to the World Health Organization (WHO) 2016 Classification2, including those with: * AML arising from MDS or another antecedent hematologic disease (AHD).\n      * AML after previous cytotoxic therapy or radiation (secondary AML).\n     \n     \n 2.  18 years of age (In Japan, 20 years of age).\n 3.  Adequate Organ Function as defined by the following: * Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) 3 x upper limit of normal (ULN), excluding subjects with liver function abnormalities due to underlying malignancy.\n      * Total serum bilirubin 2 x ULN (except subjects with documented Gilbert's syndrome).\n      * Estimated creatinine clearance 30 mL/min as calculated using the standard method for the institution.\n     \n     \n 4.  QTc interval 470 msec using the Fridericia correction (QTcF).\n 5.  All anti cancer treatments (unless specified) should be discontinued 2 weeks from study entry, for example: targeted chemotherapy, radiotherapy, investigational agents, hormones, anagrelide or cytokines. * For control of rapidly progressing leukemia, all trans retinoic acid (ATRA), hydroxyurea, and/or leukopheresis may be used before and for up to 1 week after the first dose of glasdegib.\n     \n     \n 6.  Serum or urine pregnancy test (for female subjects of childbearing potential) with a minimum sensitivity of 25 IU/L or equivalent units of human chorionic gonadotropin (hCG) negative at screening.\n 7.  Male and female subjects of childbearing potential and at risk for pregnancy must agree to use at least one highly effective method of contraception throughout the study and for 180 days after the last dose of azacitidine, cytarabine, or daunorubicin; and the last dose of glasdegib or placebo, whichever occurs later.\n 8.  Female subjects of non childbearing potential must meet at least 1 of the following criteria: 1. Have undergone a documented hysterectomy and/or bilateral oophorectomy;\n      2. Have medically confirmed ovarian failure; or\n      3. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; status may be confirmed by having a serum follicle stimulating hormone (FSH) level confirming the postmenopausal state.\n     \n     All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential.\n     \n     \n 9.  Consent to a saliva sample collection for a germline comparator, unless prohibited by local regulations or ethics committee (EC) decision.\n 10. Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.\n 11. Subjects who are willing and able to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures (including bone marrow [BM] assessments).\n\n","\n\nSubjects with any of the following characteristics/conditions will not be included in the study:\n\n 1.  Acute Promyelocytic Leukemia (APL) and APLwith PML RARA, subjects (WHO 2016 classification).\n 2.  AML with BCR ABL1 or t(9;22)(q34;q11.2) as a sole abnormality. * Complex genetics may include t(9;22) cytogenetic translocation.\n     \n     \n 3.  Subjects with known active CNS leukemia.\n 4.  Participation in other clinical studies involving other investigational drug(s) (Phases 1 4) within 4 weeks prior study entry and/or during study participation.\n 5.  Subjects known to be refractory to platelet or packed red cell transfusions per Institutional Guidelines, or a patient who refuses blood product support.\n 6.  Subjects with another active malignancy on treatment with the exception of basal cell carcinoma, non melanoma skin cancer, cervical carcinoma in situ. Other prior or concurrent malignancies will be considered on a case by case basis.\n 7.  Any one of the following ongoing or in the previous 6 months: myocardial infarction, congenital long QT syndrome, Torsades de pointes, symptomatic arrhythmias (including sustained ventricular tachyarrhythmia), right or left bundle branch block and bifascicular block, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (CHF New York Heart Association class III or IV), cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism; as well as bradycardia defined as <50 bpms.\n 8.  Subjects with an active, life threatening or clinically significant uncontrolled systemic infection not related to AML.\n 9.  Subjects with left ventricular ejection fraction (LVEF) <50% are excluded from the Intensive Chemotherapy Study only.\n 10. Cumulative anthracycline dose equivalent of 550 mg/m2 of daunorubicin for the Intensive Chemotherapy Study only.\n 11. Known malabsorption syndrome or other condition that may significantly impair absorption of study medication in the investigator's judgment (eg, gastrectomy, lap band, Crohn's disease) and inability or unwillingness to swallow tablets or capsules.\n 12. Current use or anticipated requirement for drugs that are known strong CYP3A4/5 inducers.\n 13. Concurrent administration of herbal preparations.\n 14. Major surgery or radiation within 4 weeks of starting study treatment.\n 15. Documented or suspected hypersensitivity to any one of the following: * For subjects assigned to intensive chemotherapy, documented or suspected hypersensitivity to cytarabine (not including drug fever or exanthema, including known cerebellar side effects) or daunorubicin.\n      * For subjects assigned to non intensive chemotherapy, documented or suspected hypersensitivity to azacitidine or mannitol.\n     \n     \n 16. Known active drug or alcohol abuse.\n 17. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.\n 18. Pregnant females or breastfeeding female subjects.\n 19. Known recent or active suicidal ideation or behavior.\n 20. Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.","FSH",null,"Protein","Ovary","Actual","2018-01-31","Actual","Anticipated","2025-07-22","Anticipated","2018-10-01","2017-12-21","2018-01-23","2018-10-25","Yes","glasdegib;\nuntreated;\nHedgehog Inhibitor","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"All",null,"No","Yes\nInformation relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests",null,"URL: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1371019&StudyName=A+Randomized+%281%3A1%29%2C+Double+Blind%2C+Multi+Center%2C+Placebo+Controlled+Study+Evaluating+Intensive+Chemotherapy+With+Or+Without+Glasdegib+%28pf+04449913%29+Or+Azacitidine+%28aza%29+With+Or+Without+Glasdegib+In+Patients+With+Previously+Untreated+Acute+Myeloid+Leukemia [https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1371019&StudyName=A+Randomized+%281%3A1%29%2C+Double+Blind%2C+Multi+Center%2C+Placebo+Controlled+Study+Evaluating+Intensive+Chemotherapy+With+Or+Without+Glasdegib+%28pf+04449913%29+Or+Azacitidine+%28aza%29+With+Or+Without+Glasdegib+In+Patients+With+Previously+Untreated+Acute+Myeloid+Leukemia] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To obtain contact information for a study center near you, click here.",null,"Yes","No",{"$nulls":17},"2017-002822-19|BRIGHT|BRIGHT AML1019","EudraCT Number|Alias Study Number","Overall survival","5 years after last subject randomized",null,"Fatigue score measured by the MD Anderson Symptom Inventory (MDASI)-AML/MDS questionnaire|Rate of Complete Remission (CR) (including CR with minimal residual disease (MRD)-negative as assessed by multiparametric flow cytometry)|Duration of response (defined as CR [includes CR-MRD negative]/CRi or CR/CRh as appropriate)|Time to response (CR[includes CR-MRD negative)]/CR with partial hematologic rcovery (CRh) as appropriate)|Event-free Survival|Patient Reported Outcomes (PROs) as measured by the M.D. Anderson Symptom Inventory AML/MDS Module (MDASI-AML/MDS)|Adverse events as graded by NCI CTCAE v4.03|Laboratory abnormalities as graded by NCI CTCAE v4.03|For the intensive study, the plasma trough concentration (Ctrough) will be analyzed|QTc interval|PROs as measured by Patient Global Impression of Change (PGIC)|Patient Reported Outcomes (PROs) as measured by EuroQoL 5 Dimension questionnaire 5-Level version (EQ-5D-5L)|Patient Reported Outcomes (PROs) as measured by Patient Global Impression of Symptoms (PGIS)|Complete Remission with incomplete hematologic recovery (CRi)|Rate of morphological leukemia-free state (MLFS)|Rate of Partial Remission (PR)|Rate of Complete Remission with partial hematological recovery (CRh) for the Non-intensive study only only|Minimum Observed Plasma Trough Concentratrion of glasdegib in the Intensive Study|Minimum Observed Plasma Trough Concentration of glasdegib in the Non-intensive study","Scale is from 0-10 where 0 is not present and 10 is as bad as you can image.|Response as defined by the 2017 European LeukemiaNet (ELN) recommendations.|5 years after last subject randomized, consent withdrawal, or death|Measurement Scale from 0-10.|PK samples taken on Induction(s) Day 1 (1 and 4 hours post induction); Induction(s) Day 10 (pre-dose, 1 and 4 hours post dose); Day 1 of each Consolidation cycle (pre-dose, 1 and 4 hours post dose)|One question asking for description of leukemia symptoms.|Series of questions that ask for information that best describes health.|One question asking for information regarding leukemia symptoms.|Its the minimum trough concentration in plasma of glasdegib following multiple daily dosing to steady state.|It is the minimum trough concentration in plasma of glasdegib following multiple daily dosing to steady state.","5 years after last subject randomized, consent withdrawal, or death|2 years after last dose of study therapy|5 years after last patient randomized, withdrawal, or death|5 years after last subject randomized, withdrawal, or death|Day 10 of Induction Cycle and Day 1 of each Consolidation Cycle|Cycle 1 Day 15 and Cycles 2 and 3 on Day 1","ClinicalTrials.gov_Inquiries@pfizer.com","Pfizer CT.gov Call Center","1-800-718-1021","Darlinghurst, New South Wales, Australia, 2010|Brno, Czechia, 625 00 Nemocnicni LekarnaBrno, Czechia, 625 00 InternÃ­ HematologickÃ¡ Klinika, Fakultni Nemocnice KrÃ¡lovskÃ© VinohradyPraha 10, Czechia, 100 34 Ãšstavni LÃ©kÃ¡rnaPraha 10, Czechia, 100 34|Nagoya, Aichi, Japan, 466-8650|Akita, Japan, 010-8543 Kyushu University HospitalFukuoka, Japan, 812-8582 National Hospital Organization Kumamoto Medical CenterKumamoto, Japan, 860-0008 Nagasaki University HospitalNagasaki, Japan, 852-8501 Tokyo Medical University HospitalTokyo, Japan, 160-0023 Korea, Republic Of, Jeollabuk-Do Chonbuk National University HospitalJeonju-Si, Jeollabuk-Do, Korea, Republic Of, 54907 Korea, Republic Of, Jeollanam-Do Chonnam National University Hwasun HospitalHwasun-Gun, Jeollanam-Do, Korea, Republic Of, 58128 Korea, Republic Of Department Of Pharmacy, Inje University Busan Paik HospitalBusan, Korea, Republic Of, 47392 Inje University Busan Paik HospitalBusan, Korea, Republic Of, 47392 Clinical Trial Pharmacy, Keimyung University Dongsan HospitalDaegu, Korea, Republic Of, 41931 Keimyung University Dongsan HospitalDaegu, Korea, Republic Of, 41931 Gachon University Gil Medical CenterIncheon, Korea, Republic Of, 21565 Seoul National University HospitalSeoul, Korea, Republic Of, 03080 Clinical Trial Center, Severance Hospital, Yonsei University Health System (Drug Shipment Only)Seoul, Korea, Republic Of, 03722 Severance Hospital, Yonsei University Health SystemSeoul, Korea, Republic Of, 03722 Department Of Pharmacy, Samsung Medical CenterSeoul, Korea, Republic Of, 06351 Samsung Medical CenterSeoul, Korea, Republic Of, 06351 The Catholic University Of Korea Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591 The Catholic University Of Korea, Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591|Yoshida-Gun, Fukui, Japan, 910-1193|Maebashi, Gunma, Japan, 371-8511|Kobe-Shi, Hyogo, Japan, 650-0017|Yokohama, Kanagawa, Japan, 232-0024|Sendai, Miyagi, Japan, 980-8574|Osaka-City, Osaka, Japan, 545-8586 Kindai University HospitalOsaka-Sayama, Osaka, Japan, 589-8511|Sunto-Gun, Shizuoka, Japan, 411-8777|Tachikawa, Tokyo, Japan, 190-0014|Gdansk, Poland, 80-952|Craiova, Dolj, Romania, 200143 Russian Federation Sbhi Cch No. 40 Hd MoscowMoscow, Russian Federation, 129301 State Budgetary Healthcare Institution Of MoscowMoscow, Russian Federation, 129301 State Budgetary Institution Of Ryazan Region 'Regional Clinical Hospital' (Sbi Rr Rch)Ryazan, Russian Federation, 390039 Drug Shipment Address:Saint Petersburg, Russian Federation, 191024 Fsbi Russrhti Fmba Of|Barcelona, Spain, 08003 Hospital De La Santa Creu I Sant PauBarcelona, Spain, 08025 Hospital Universitario Arnau De VilanovaLleida, Spain, 25198 Hospital General Universitario Gregorio MaranonMadrid, Spain, 28007 Hospital Universitario Ramon Y CajalMadrid, Spain, 28034 Hospital Universitario Virgen Del RocioSevilla, Spain, 41013 Hospital Universitari I Politecnic La FeValencia, Spain, 46026 Taiwan Department Of Clinical Trial Pharmacy, Taipei Veterans General HospitalTaipei, Taiwan, 11217 Taipei Veterans General HospitalTaipei, Taiwan, 11217 Division Of Pharmacy, Koo Foundation Sun Yat-Sen Cancer CenterTaipei, Taiwan, 112 Koo Foundation Sun Yat-Sen Cancer CenterTaipei, Taiwan, 112 Chang Gung Memorial Hospital-Linkou BranchTaoyuan City, Taiwan, 333 Chemotherapy Pharmacy, Chang Gung Memorial Hospital-Linkou BranchTaoyuan City, Taiwan, 333|Los Angeles, California, United States, 90095 Ucla Department Of MedicineLos Angeles, California, United States, 90095 Ucla Hematology/Oncology ClinicLos Angeles, California, United States, 90095 Ucla Ronald Reagan Medical CenterLos Angeles, California, United States, 90095 Uc Irvine Health - Chao Family Comprehensive Cancer CenterOrange, California, United States, 92868-3201 Uc Irvine Medical CenterOrange, California, United States, 92868-3201 Ucsf Helen Diller Family Comprehensive Cancer CenterSan Francisco, California, United States, 94143 University Of California, San Francisco Medical CenterSan Francisco, California, United States, 94143 University Of California, San FranciscoSan Francisco, California, United States, 94143|Kansas City, Missouri, United States, 64132|Lake Success, New York, United States, 11042 North Shore University HospitalManhasset, New York, United States, 11030 Long Island Jewish Medical CenterNew Hyde Park, New York, United States, 11040|Cleveland, Ohio, United States, 44106 University Hospitals Cleveland Medical CenterCleveland, Ohio, United States, 44106 Cleveland Clinic FoundationCleveland, Ohio, United States, 44195|Nashville, Tennessee, United States, 37203|San Antonio, Texas, United States, 78229 Methodist Healthcare System Of San AntonioSan Antonio, Texas, United States, 78229 Methodist Hospital Investigational PharmacySan Antonio, Texas, United States, 78229|Seattle, Washington, United States, 98104 Swedish Investigational Drug Services PharmacySeattle, Washington, United States, 98104 Swedish Medical CenterSeattle, Washington, United States, 98122","California|Missouri|New York|Ohio|Tennessee|Texas|Washington","Australia|Czechia|Japan|Poland|Romania|Spain|United States","New South Wales St Vincent's Hospital Sydney|Interni Hematologicka A Onkologicka Klinika, Fakultni Nemocnice Brno|Aichi Japanese Red Cross Nagoya Daini Hospital|Akita University Hospital|Fukui University Of Fukui Hospital|Gunma Gunma University Hospital|Hyogo Kobe University Hospital|Kanagawa Yokohama City University Medical Center|Miyagi Tohoku University Hospital|Osaka Osaka City University Hospital|Shizuoka Shizuoka Cancer Center|Tokyo National Hospital Organization Disaster Medical Center|Klinika Hematologii I Transplantologii Uniwersyteckie Centrum Kliniczne|Dolj Spitalul Clinic Municipal Filantropia Craiova, Sectia Clinica Hematologie|Hospital Del Mar|Rrmc - Ucla|Midamerica Division, Inc., C/O Research Medical Center|Northwell Health Monter Cancer Center|Taussig Cancer Center Investigational Pharmacy|The Sarah Cannon Research Institute|Blood Cancer And Stem Cell Transplant Clinic|Swedish Cancer Institute",{"$nulls":3},"Pfizer CT.gov Call Center","2018-10-25","2020-05-25T16:39:29.604","2020-05-26T17:10:42.972","NCT03416179"]
["5ecbf4c211702c1b1b916bc1","NCT03416179","2018-11-05","Pfizer","PFE","Recruiting","A Study Evaluating Intensive Chemotherapy With or Without Glasdegib or Azacitidine With or Without Glasdegib In Patients With Previously Untreated Acute Myeloid Leukemia (BRIGHT AML1019)","Glasdegib|Cytarabine|Daunorubicin|Azacitidine","Hh Inhibitor|DNA Polymerase Inhibitor|Nucleic Acid Synthesis Inhibitor|TOP2 Inhibitor|DNA Mtase Inhibitor","Yes","['Glasdegib']","Unknown",null,"Phase 3",4,720,"Anticipated","2018-04-20","2021-06-13","OS","Overall Survival",{"$nulls":3},"Glasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).\n\nGlasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).","Two separate registration trials conducted under one protocol number are proposed to adequately and independently evaluate the addition of glasdegib in intensive and non-intensive chemotherapy populations. Each study will have an experimental treatment arm and a placebo arm. Endpoints are the same for each study except where specifically indicated.\n\nAssignment to the Intensive Study or the Non-Intensive Study will be made by the Investigator based on the 2017 European LeukemiaNet (ELN) recommendations.\n\nStudy B1371019 is a randomized (1:1), double-blind, multi-center, placebo controlled study of chemotherapy in combination with glasdegib versus chemotherapy in combination with placebo in adult patients with previously untreated AML.\n\nGlasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).\n\nGlasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).","A RANDOMIZED (1:1), DOUBLE-BLIND, MULTI-CENTER, PLACEBO CONTROLLED STUDY EVALUATING INTENSIVE CHEMOTHERAPY WITH OR WITHOUT GLASDEGIB (PF-04449913) OR AZACITIDINE (AZA) WITH OR WITHOUT GLASDEGIB IN PATIENTS WITH PREVIOUSLY UNTREATED ACUTE MYELOID LEUKEMIA","B1371019","Leukemia, Myeloid, Acute","Acute Leukemia|Acute Myeloid Leukemia|Myeloid Leukemia|Leukemia","Oncology Hematological","Oncology","Experimental|Placebo Comparator","Arm A (Intensive Study)|Arm B (Intensive Study)|Arm A (Non-intensive study)|Arm B (Non-intensive study)","Glasdegib + '7+3' Induction(s)|Placebo + '7+3' Induction(s)|Glasdegib + azacitidine|Placebo + azacitidine","Drug|Procedure","glasdegib|daunorubicin + cytarabine|cytarabine|HSCT|Placebo|azacitidine","Daily Glasdegib (100 mg, PO), beginning on Day 1 and is to continue up to 2 years post randomization.\n\nFollowing consolidation therapy, glasdegib or placebo will be administered daily for up to 2 years after randomization or until they have minimal residual disease (MRD) negative disease, whichever comes first.\n\nDaily Glasdegib (100 mg, PO) or matching placebo will continue throughout Induction(s) and Consolidation therapies regardless of dose modifications/delays in the chemotherapy.|Consolidation with single agent cytarabine 3 g/m2 IV for adults <60 years and 1 g/m2 for adults 60 years over 3 BID on Days 1, 3, and 5, every 28 days for up to 4 cycles or alternative single agent cytarabine consolidation schedules may be used per local prescribing information.|If required, and done per standard of care post Induction(s).|Azacitidine (75 mg/m2, SC or IV) daily for 7 days, in 28 day cycles for as long as they do not meet the criteria for disease progression, unacceptable toxicity, consent withdrawal, or death.|Matching placebo (PO) is to be administered by mouth daily beginning on Day 1 of chemotherapy and will continue if subjects demonstrate reasonable evidence of clinical benefit and do not meet the criteria for progression regardless of any delays/modifications in the chemotherapy treatment. Subjects will continue placebo until disease progression, unacceptable toxicity, consent withdrawal, or death, whichever comes first.","PF-04449913","Arm A (Intensive Study)|Arm B (Intensive Study)|Arm A (Non-intensive study)|Arm B (Non-intensive study)","\n\nSubjects must meet all of the following inclusion criteria to be eligible for enrollment into the Intensive and Non Intensive study (unless where indicated):\n\n 1.  Subjects with untreated AML according to the World Health Organization (WHO) 2016 Classification2, including those with: * AML arising from MDS or another antecedent hematologic disease (AHD).\n      * AML after previous cytotoxic therapy or radiation (secondary AML).\n     \n     \n 2.  18 years of age (In Japan, 20 years of age).\n 3.  Adequate Organ Function as defined by the following: * Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) 3 x upper limit of normal (ULN), excluding subjects with liver function abnormalities due to underlying malignancy.\n      * Total serum bilirubin 2 x ULN (except subjects with documented Gilbert's syndrome).\n      * Estimated creatinine clearance 30 mL/min as calculated using the standard method for the institution.\n     \n     \n 4.  QTc interval 470 msec using the Fridericia correction (QTcF).\n 5.  All anti cancer treatments (unless specified) should be discontinued 2 weeks from study entry, for example: targeted chemotherapy, radiotherapy, investigational agents, hormones, anagrelide or cytokines. * For control of rapidly progressing leukemia, all trans retinoic acid (ATRA), hydroxyurea, and/or leukopheresis may be used before and for up to 1 week after the first dose of glasdegib.\n     \n     \n 6.  Serum or urine pregnancy test (for female subjects of childbearing potential) with a minimum sensitivity of 25 IU/L or equivalent units of human chorionic gonadotropin (hCG) negative at screening.\n 7.  Male and female subjects of childbearing potential and at risk for pregnancy must agree to use at least one highly effective method of contraception throughout the study and for 180 days after the last dose of azacitidine, cytarabine, or daunorubicin; and the last dose of glasdegib or placebo, whichever occurs later.\n 8.  Female subjects of non childbearing potential must meet at least 1 of the following criteria: 1. Have undergone a documented hysterectomy and/or bilateral oophorectomy;\n      2. Have medically confirmed ovarian failure; or\n      3. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; status may be confirmed by having a serum follicle stimulating hormone (FSH) level confirming the postmenopausal state.\n     \n     All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential.\n     \n     \n 9.  Consent to a saliva sample collection for a germline comparator, unless prohibited by local regulations or ethics committee (EC) decision.\n 10. Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.\n 11. Subjects who are willing and able to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures (including bone marrow [BM] assessments).\n\n","\n\nSubjects with any of the following characteristics/conditions will not be included in the study:\n\n 1.  Acute Promyelocytic Leukemia (APL) and APLwith PML RARA, subjects (WHO 2016 classification).\n 2.  AML with BCR ABL1 or t(9;22)(q34;q11.2) as a sole abnormality. * Complex genetics may include t(9;22) cytogenetic translocation.\n     \n     \n 3.  Subjects with known active CNS leukemia.\n 4.  Participation in other clinical studies involving other investigational drug(s) (Phases 1 4) within 4 weeks prior study entry and/or during study participation.\n 5.  Subjects known to be refractory to platelet or packed red cell transfusions per Institutional Guidelines, or a patient who refuses blood product support.\n 6.  Subjects with another active malignancy on treatment with the exception of basal cell carcinoma, non melanoma skin cancer, cervical carcinoma in situ. Other prior or concurrent malignancies will be considered on a case by case basis.\n 7.  Any one of the following ongoing or in the previous 6 months: myocardial infarction, congenital long QT syndrome, Torsades de pointes, symptomatic arrhythmias (including sustained ventricular tachyarrhythmia), right or left bundle branch block and bifascicular block, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (CHF New York Heart Association class III or IV), cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism; as well as bradycardia defined as <50 bpms.\n 8.  Subjects with an active, life threatening or clinically significant uncontrolled systemic infection not related to AML.\n 9.  Subjects with left ventricular ejection fraction (LVEF) <50% are excluded from the Intensive Chemotherapy Study only.\n 10. Cumulative anthracycline dose equivalent of 550 mg/m2 of daunorubicin for the Intensive Chemotherapy Study only.\n 11. Known malabsorption syndrome or other condition that may significantly impair absorption of study medication in the investigator's judgment (eg, gastrectomy, lap band, Crohn's disease) and inability or unwillingness to swallow tablets or capsules.\n 12. Current use or anticipated requirement for drugs that are known strong CYP3A4/5 inducers.\n 13. Concurrent administration of herbal preparations.\n 14. Major surgery or radiation within 4 weeks of starting study treatment.\n 15. Documented or suspected hypersensitivity to any one of the following: * For subjects assigned to intensive chemotherapy, documented or suspected hypersensitivity to cytarabine (not including drug fever or exanthema, including known cerebellar side effects) or daunorubicin.\n      * For subjects assigned to non intensive chemotherapy, documented or suspected hypersensitivity to azacitidine or mannitol.\n     \n     \n 16. Known active drug or alcohol abuse.\n 17. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.\n 18. Pregnant females or breastfeeding female subjects.\n 19. Known recent or active suicidal ideation or behavior.\n 20. Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.","FSH",null,"Protein","Ovary","Actual","2018-01-31","Actual","Anticipated","2025-07-22","Anticipated","2018-11-01","2017-12-21","2018-01-23","2018-11-01","Yes","glasdegib;\nuntreated;\nHedgehog Inhibitor","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"All",null,"No","Yes\nInformation relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests",null,"URL: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1371019&StudyName=A+Randomized+%281%3A1%29%2C+Double+Blind%2C+Multi+Center%2C+Placebo+Controlled+Study+Evaluating+Intensive+Chemotherapy+With+Or+Without+Glasdegib+%28pf+04449913%29+Or+Azacitidine+%28aza%29+With+Or+Without+Glasdegib+In+Patients+With+Previously+Untreated+Acute+Myeloid+Leukemia [https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1371019&StudyName=A+Randomized+%281%3A1%29%2C+Double+Blind%2C+Multi+Center%2C+Placebo+Controlled+Study+Evaluating+Intensive+Chemotherapy+With+Or+Without+Glasdegib+%28pf+04449913%29+Or+Azacitidine+%28aza%29+With+Or+Without+Glasdegib+In+Patients+With+Previously+Untreated+Acute+Myeloid+Leukemia] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To obtain contact information for a study center near you, click here.",null,"Yes","No",{"$nulls":17},"2017-002822-19|BRIGHT|BRIGHT AML1019","EudraCT Number|Alias Study Number","Overall survival","5 years after last subject randomized",null,"Fatigue score measured by the MD Anderson Symptom Inventory (MDASI)-AML/MDS questionnaire|Rate of Complete Remission (CR) (including CR with minimal residual disease (MRD)-negative as assessed by multiparametric flow cytometry)|Duration of response (defined as CR [includes CR-MRD negative]/CRi or CR/CRh as appropriate)|Time to response (CR[includes CR-MRD negative)]/CR with partial hematologic rcovery (CRh) as appropriate)|Event-free Survival|Patient Reported Outcomes (PROs) as measured by the M.D. Anderson Symptom Inventory AML/MDS Module (MDASI-AML/MDS)|Adverse events as graded by NCI CTCAE v4.03|Laboratory abnormalities as graded by NCI CTCAE v4.03|For the intensive study, the plasma trough concentration (Ctrough) will be analyzed|QTc interval|PROs as measured by Patient Global Impression of Change (PGIC)|Patient Reported Outcomes (PROs) as measured by EuroQoL 5 Dimension questionnaire 5-Level version (EQ-5D-5L)|Patient Reported Outcomes (PROs) as measured by Patient Global Impression of Symptoms (PGIS)|Complete Remission with incomplete hematologic recovery (CRi)|Rate of morphological leukemia-free state (MLFS)|Rate of Partial Remission (PR)|Rate of Complete Remission with partial hematological recovery (CRh) for the Non-intensive study only only|Minimum Observed Plasma Trough Concentratrion of glasdegib in the Intensive Study|Minimum Observed Plasma Trough Concentration of glasdegib in the Non-intensive study","Scale is from 0-10 where 0 is not present and 10 is as bad as you can image.|Response as defined by the 2017 European LeukemiaNet (ELN) recommendations.|5 years after last subject randomized, consent withdrawal, or death|Measurement Scale from 0-10.|PK samples taken on Induction(s) Day 1 (1 and 4 hours post induction); Induction(s) Day 10 (pre-dose, 1 and 4 hours post dose); Day 1 of each Consolidation cycle (pre-dose, 1 and 4 hours post dose)|One question asking for description of leukemia symptoms.|Series of questions that ask for information that best describes health.|One question asking for information regarding leukemia symptoms.|Its the minimum trough concentration in plasma of glasdegib following multiple daily dosing to steady state.|It is the minimum trough concentration in plasma of glasdegib following multiple daily dosing to steady state.","5 years after last subject randomized, consent withdrawal, or death|2 years after last dose of study therapy|5 years after last patient randomized, withdrawal, or death|5 years after last subject randomized, withdrawal, or death|Day 10 of Induction Cycle and Day 1 of each Consolidation Cycle|Cycle 1 Day 15 and Cycles 2 and 3 on Day 1","ClinicalTrials.gov_Inquiries@pfizer.com","Pfizer CT.gov Call Center","1-800-718-1021","Darlinghurst, New South Wales, Australia, 2010|Brno, Czechia, 625 00 Nemocnicni LekarnaBrno, Czechia, 625 00 InternÃ­ HematologickÃ¡ Klinika, Fakultni Nemocnice KrÃ¡lovskÃ© VinohradyPraha 10, Czechia, 100 34 Ãšstavni LÃ©kÃ¡rnaPraha 10, Czechia, 100 34|Nagoya, Aichi, Japan, 466-8650|Akita, Japan, 010-8543 Kyushu University HospitalFukuoka, Japan, 812-8582 National Hospital Organization Kumamoto Medical CenterKumamoto, Japan, 860-0008 Nagasaki University HospitalNagasaki, Japan, 852-8501 Tokyo Medical University HospitalTokyo, Japan, 160-0023 Korea, Republic Of, Jeollabuk-Do Chonbuk National University HospitalJeonju-Si, Jeollabuk-Do, Korea, Republic Of, 54907 Korea, Republic Of, Jeollanam-Do Chonnam National University Hwasun HospitalHwasun-Gun, Jeollanam-Do, Korea, Republic Of, 58128 Korea, Republic Of Department Of Pharmacy, Inje University Busan Paik HospitalBusan, Korea, Republic Of, 47392 Inje University Busan Paik HospitalBusan, Korea, Republic Of, 47392 Clinical Trial Pharmacy, Keimyung University Dongsan HospitalDaegu, Korea, Republic Of, 41931 Keimyung University Dongsan HospitalDaegu, Korea, Republic Of, 41931 Gachon University Gil Medical CenterIncheon, Korea, Republic Of, 21565 Seoul National University HospitalSeoul, Korea, Republic Of, 03080 Clinical Trial Center, Severance Hospital, Yonsei University Health System (Drug Shipment Only)Seoul, Korea, Republic Of, 03722 Severance Hospital, Yonsei University Health SystemSeoul, Korea, Republic Of, 03722 Department Of Pharmacy, Samsung Medical CenterSeoul, Korea, Republic Of, 06351 Samsung Medical CenterSeoul, Korea, Republic Of, 06351 The Catholic University Of Korea Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591 The Catholic University Of Korea, Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591|Yoshida-Gun, Fukui, Japan, 910-1193|Maebashi, Gunma, Japan, 371-8511|Kobe-Shi, Hyogo, Japan, 650-0017|Yokohama, Kanagawa, Japan, 232-0024|Sendai, Miyagi, Japan, 980-8574|Osaka-City, Osaka, Japan, 545-8586 Kindai University HospitalOsaka-Sayama, Osaka, Japan, 589-8511|Sunto-Gun, Shizuoka, Japan, 411-8777|Tachikawa, Tokyo, Japan, 190-0014|Gdansk, Poland, 80-952|Craiova, Dolj, Romania, 200143 Russian Federation Sbhi Cch No. 40 Hd MoscowMoscow, Russian Federation, 129301 State Budgetary Healthcare Institution Of MoscowMoscow, Russian Federation, 129301 State Budgetary Institution Of Ryazan Region 'Regional Clinical Hospital' (Sbi Rr Rch)Ryazan, Russian Federation, 390039 Drug Shipment Address:Saint Petersburg, Russian Federation, 191024 Fsbi Russrhti Fmba Of|Barcelona, Spain, 08003 Hospital De La Santa Creu I Sant PauBarcelona, Spain, 08025 Hospital Universitario Arnau De VilanovaLleida, Spain, 25198 Hospital General Universitario Gregorio MaranonMadrid, Spain, 28007 Hospital Universitario Ramon Y CajalMadrid, Spain, 28034 Hospital Universitario Virgen Del RocioSevilla, Spain, 41013 Hospital Universitari I Politecnic La FeValencia, Spain, 46026 Taiwan Department Of Clinical Trial Pharmacy, Taipei Veterans General HospitalTaipei, Taiwan, 11217 Taipei Veterans General HospitalTaipei, Taiwan, 11217 Division Of Pharmacy, Koo Foundation Sun Yat-Sen Cancer CenterTaipei, Taiwan, 112 Koo Foundation Sun Yat-Sen Cancer CenterTaipei, Taiwan, 112 Chang Gung Memorial Hospital-Linkou BranchTaoyuan City, Taiwan, 333 Chemotherapy Pharmacy, Chang Gung Memorial Hospital-Linkou BranchTaoyuan City, Taiwan, 333|Sutton, Surrey, United Kingdom, Sm2 5Pt|Los Angeles, California, United States, 90095 Ucla Department Of MedicineLos Angeles, California, United States, 90095 Ucla Hematology/Oncology ClinicLos Angeles, California, United States, 90095 Ucla Ronald Reagan Medical CenterLos Angeles, California, United States, 90095 Uc Irvine Health - Chao Family Comprehensive Cancer CenterOrange, California, United States, 92868-3201 Uc Irvine Medical CenterOrange, California, United States, 92868-3201 Ucsf Helen Diller Family Comprehensive Cancer CenterSan Francisco, California, United States, 94143 University Of California, San Francisco Medical CenterSan Francisco, California, United States, 94143 University Of California, San FranciscoSan Francisco, California, United States, 94143|Kansas City, Missouri, United States, 64132|Lake Success, New York, United States, 11042 North Shore University HospitalManhasset, New York, United States, 11030 Long Island Jewish Medical CenterNew Hyde Park, New York, United States, 11040|Cleveland, Ohio, United States, 44106 University Hospitals Cleveland Medical CenterCleveland, Ohio, United States, 44106 Cleveland Clinic FoundationCleveland, Ohio, United States, 44195|Nashville, Tennessee, United States, 37203|Dallas, Texas, United States, 75246 Baylor University Medical CenterDallas, Texas, United States, 75246 Blood Cancer And Stem Cell Transplant ClinicSan Antonio, Texas, United States, 78229 Methodist Healthcare System Of San AntonioSan Antonio, Texas, United States, 78229 Methodist Hospital Investigational PharmacySan Antonio, Texas, United States, 78229|Seattle, Washington, United States, 98104 Swedish Investigational Drug Services PharmacySeattle, Washington, United States, 98104 Swedish Medical CenterSeattle, Washington, United States, 98122","California|Missouri|New York|Ohio|Tennessee|Texas|Washington","Australia|Czechia|Japan|Poland|Romania|Spain|United Kingdom|United States","New South Wales St Vincent's Hospital Sydney|Interni Hematologicka A Onkologicka Klinika, Fakultni Nemocnice Brno|Aichi Japanese Red Cross Nagoya Daini Hospital|Akita University Hospital|Fukui University Of Fukui Hospital|Gunma Gunma University Hospital|Hyogo Kobe University Hospital|Kanagawa Yokohama City University Medical Center|Miyagi Tohoku University Hospital|Osaka Osaka City University Hospital|Shizuoka Shizuoka Cancer Center|Tokyo National Hospital Organization Disaster Medical Center|Klinika Hematologii I Transplantologii Uniwersyteckie Centrum Kliniczne|Dolj Spitalul Clinic Municipal Filantropia Craiova, Sectia Clinica Hematologie|Hospital Del Mar|, Surrey The Royal Marsden Nhs Foundation Trust|Rrmc - Ucla|Midamerica Division, Inc., C/O Research Medical Center|Northwell Health Monter Cancer Center|Taussig Cancer Center Investigational Pharmacy|The Sarah Cannon Research Institute|Baylor Scott And White Research Institute|Swedish Cancer Institute",{"$nulls":3},"Pfizer CT.gov Call Center","2018-11-01","2020-05-25T16:39:30.011","2020-05-26T17:10:42.972","NCT03416179"]
["5ecbf4c2fe30261b1a0483b5","NCT03416179","2018-11-06","Pfizer","PFE","Recruiting","A Study Evaluating Intensive Chemotherapy With or Without Glasdegib or Azacitidine With or Without Glasdegib In Patients With Previously Untreated Acute Myeloid Leukemia (BRIGHT AML1019)","Glasdegib|Cytarabine|Daunorubicin|Azacitidine","Hh Inhibitor|DNA Polymerase Inhibitor|Nucleic Acid Synthesis Inhibitor|TOP2 Inhibitor|DNA Mtase Inhibitor","Yes","['Glasdegib']","Unknown",null,"Phase 3",4,720,"Anticipated","2018-04-20","2021-06-13","OS","Overall Survival",{"$nulls":3},"Glasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).\n\nGlasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).","Two separate registration trials conducted under one protocol number are proposed to adequately and independently evaluate the addition of glasdegib in intensive and non-intensive chemotherapy populations. Each study will have an experimental treatment arm and a placebo arm. Endpoints are the same for each study except where specifically indicated.\n\nAssignment to the Intensive Study or the Non-Intensive Study will be made by the Investigator based on the 2017 European LeukemiaNet (ELN) recommendations.\n\nStudy B1371019 is a randomized (1:1), double-blind, multi-center, placebo controlled study of chemotherapy in combination with glasdegib versus chemotherapy in combination with placebo in adult patients with previously untreated AML.\n\nGlasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).\n\nGlasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).","A RANDOMIZED (1:1), DOUBLE-BLIND, MULTI-CENTER, PLACEBO CONTROLLED STUDY EVALUATING INTENSIVE CHEMOTHERAPY WITH OR WITHOUT GLASDEGIB (PF-04449913) OR AZACITIDINE (AZA) WITH OR WITHOUT GLASDEGIB IN PATIENTS WITH PREVIOUSLY UNTREATED ACUTE MYELOID LEUKEMIA","B1371019","Leukemia, Myeloid, Acute","Acute Leukemia|Acute Myeloid Leukemia|Myeloid Leukemia|Leukemia","Oncology Hematological","Oncology","Experimental|Placebo Comparator","Arm A (Intensive Study)|Arm B (Intensive Study)|Arm A (Non-intensive study)|Arm B (Non-intensive study)","Glasdegib + '7+3' Induction(s)|Placebo + '7+3' Induction(s)|Glasdegib + azacitidine|Placebo + azacitidine","Drug|Procedure","glasdegib|daunorubicin + cytarabine|cytarabine|HSCT|Placebo|azacitidine","Daily Glasdegib (100 mg, PO), beginning on Day 1 and is to continue up to 2 years post randomization.\n\nFollowing consolidation therapy, glasdegib or placebo will be administered daily for up to 2 years after randomization or until they have minimal residual disease (MRD) negative disease, whichever comes first.\n\nDaily Glasdegib (100 mg, PO) or matching placebo will continue throughout Induction(s) and Consolidation therapies regardless of dose modifications/delays in the chemotherapy.|Consolidation with single agent cytarabine 3 g/m2 IV for adults <60 years and 1 g/m2 for adults 60 years over 3 BID on Days 1, 3, and 5, every 28 days for up to 4 cycles or alternative single agent cytarabine consolidation schedules may be used per local prescribing information.|If required, and done per standard of care post Induction(s).|Azacitidine (75 mg/m2, SC or IV) daily for 7 days, in 28 day cycles for as long as they do not meet the criteria for disease progression, unacceptable toxicity, consent withdrawal, or death.|Matching placebo (PO) is to be administered by mouth daily beginning on Day 1 of chemotherapy and will continue if subjects demonstrate reasonable evidence of clinical benefit and do not meet the criteria for progression regardless of any delays/modifications in the chemotherapy treatment. Subjects will continue placebo until disease progression, unacceptable toxicity, consent withdrawal, or death, whichever comes first.","PF-04449913","Arm A (Intensive Study)|Arm B (Intensive Study)|Arm A (Non-intensive study)|Arm B (Non-intensive study)","\n\nSubjects must meet all of the following inclusion criteria to be eligible for enrollment into the Intensive and Non Intensive study (unless where indicated):\n\n 1.  Subjects with untreated AML according to the World Health Organization (WHO) 2016 Classification2, including those with: * AML arising from MDS or another antecedent hematologic disease (AHD).\n      * AML after previous cytotoxic therapy or radiation (secondary AML).\n     \n     \n 2.  18 years of age (In Japan, 20 years of age).\n 3.  Adequate Organ Function as defined by the following: * Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) 3 x upper limit of normal (ULN), excluding subjects with liver function abnormalities due to underlying malignancy.\n      * Total serum bilirubin 2 x ULN (except subjects with documented Gilbert's syndrome).\n      * Estimated creatinine clearance 30 mL/min as calculated using the standard method for the institution.\n     \n     \n 4.  QTc interval 470 msec using the Fridericia correction (QTcF).\n 5.  All anti cancer treatments (unless specified) should be discontinued 2 weeks from study entry, for example: targeted chemotherapy, radiotherapy, investigational agents, hormones, anagrelide or cytokines. * For control of rapidly progressing leukemia, all trans retinoic acid (ATRA), hydroxyurea, and/or leukopheresis may be used before and for up to 1 week after the first dose of glasdegib.\n     \n     \n 6.  Serum or urine pregnancy test (for female subjects of childbearing potential) with a minimum sensitivity of 25 IU/L or equivalent units of human chorionic gonadotropin (hCG) negative at screening.\n 7.  Male and female subjects of childbearing potential and at risk for pregnancy must agree to use at least one highly effective method of contraception throughout the study and for 180 days after the last dose of azacitidine, cytarabine, or daunorubicin; and the last dose of glasdegib or placebo, whichever occurs later.\n 8.  Female subjects of non childbearing potential must meet at least 1 of the following criteria: 1. Have undergone a documented hysterectomy and/or bilateral oophorectomy;\n      2. Have medically confirmed ovarian failure; or\n      3. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; status may be confirmed by having a serum follicle stimulating hormone (FSH) level confirming the postmenopausal state.\n     \n     All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential.\n     \n     \n 9.  Consent to a saliva sample collection for a germline comparator, unless prohibited by local regulations or ethics committee (EC) decision.\n 10. Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.\n 11. Subjects who are willing and able to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures (including bone marrow [BM] assessments).\n\n","\n\nSubjects with any of the following characteristics/conditions will not be included in the study:\n\n 1.  Acute Promyelocytic Leukemia (APL) and APLwith PML RARA, subjects (WHO 2016 classification).\n 2.  AML with BCR ABL1 or t(9;22)(q34;q11.2) as a sole abnormality. * Complex genetics may include t(9;22) cytogenetic translocation.\n     \n     \n 3.  Subjects with known active CNS leukemia.\n 4.  Participation in other clinical studies involving other investigational drug(s) (Phases 1 4) within 4 weeks prior study entry and/or during study participation.\n 5.  Subjects known to be refractory to platelet or packed red cell transfusions per Institutional Guidelines, or a patient who refuses blood product support.\n 6.  Subjects with another active malignancy on treatment with the exception of basal cell carcinoma, non melanoma skin cancer, cervical carcinoma in situ. Other prior or concurrent malignancies will be considered on a case by case basis.\n 7.  Any one of the following ongoing or in the previous 6 months: myocardial infarction, congenital long QT syndrome, Torsades de pointes, symptomatic arrhythmias (including sustained ventricular tachyarrhythmia), right or left bundle branch block and bifascicular block, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (CHF New York Heart Association class III or IV), cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism; as well as bradycardia defined as <50 bpms.\n 8.  Subjects with an active, life threatening or clinically significant uncontrolled systemic infection not related to AML.\n 9.  Subjects with left ventricular ejection fraction (LVEF) <50% are excluded from the Intensive Chemotherapy Study only.\n 10. Cumulative anthracycline dose equivalent of 550 mg/m2 of daunorubicin for the Intensive Chemotherapy Study only.\n 11. Known malabsorption syndrome or other condition that may significantly impair absorption of study medication in the investigator's judgment (eg, gastrectomy, lap band, Crohn's disease) and inability or unwillingness to swallow tablets or capsules.\n 12. Current use or anticipated requirement for drugs that are known strong CYP3A4/5 inducers.\n 13. Concurrent administration of herbal preparations.\n 14. Major surgery or radiation within 4 weeks of starting study treatment.\n 15. Documented or suspected hypersensitivity to any one of the following: * For subjects assigned to intensive chemotherapy, documented or suspected hypersensitivity to cytarabine (not including drug fever or exanthema, including known cerebellar side effects) or daunorubicin.\n      * For subjects assigned to non intensive chemotherapy, documented or suspected hypersensitivity to azacitidine or mannitol.\n     \n     \n 16. Known active drug or alcohol abuse.\n 17. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.\n 18. Pregnant females or breastfeeding female subjects.\n 19. Known recent or active suicidal ideation or behavior.\n 20. Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.","FSH",null,"Protein","Ovary","Actual","2018-01-31","Actual","Anticipated","2025-07-22","Anticipated","2018-11-01","2017-12-21","2018-01-23","2018-11-03","Yes","glasdegib;\nuntreated;\nHedgehog Inhibitor","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"All",null,"No","Yes\nInformation relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests",null,"URL: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1371019&StudyName=A+Randomized+%281%3A1%29%2C+Double+Blind%2C+Multi+Center%2C+Placebo+Controlled+Study+Evaluating+Intensive+Chemotherapy+With+Or+Without+Glasdegib+%28pf+04449913%29+Or+Azacitidine+%28aza%29+With+Or+Without+Glasdegib+In+Patients+With+Previously+Untreated+Acute+Myeloid+Leukemia [https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1371019&StudyName=A+Randomized+%281%3A1%29%2C+Double+Blind%2C+Multi+Center%2C+Placebo+Controlled+Study+Evaluating+Intensive+Chemotherapy+With+Or+Without+Glasdegib+%28pf+04449913%29+Or+Azacitidine+%28aza%29+With+Or+Without+Glasdegib+In+Patients+With+Previously+Untreated+Acute+Myeloid+Leukemia] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To obtain contact information for a study center near you, click here.",null,"Yes","No",{"$nulls":17},"2017-002822-19|BRIGHT|BRIGHT AML1019","EudraCT Number|Alias Study Number","Overall survival","5 years after last subject randomized",null,"Fatigue score measured by the MD Anderson Symptom Inventory (MDASI)-AML/MDS questionnaire|Rate of Complete Remission (CR) (including CR with minimal residual disease (MRD)-negative as assessed by multiparametric flow cytometry)|Duration of response (defined as CR [includes CR-MRD negative]/CRi or CR/CRh as appropriate)|Time to response (CR[includes CR-MRD negative)]/CR with partial hematologic rcovery (CRh) as appropriate)|Event-free Survival|Patient Reported Outcomes (PROs) as measured by the M.D. Anderson Symptom Inventory AML/MDS Module (MDASI-AML/MDS)|Adverse events as graded by NCI CTCAE v4.03|Laboratory abnormalities as graded by NCI CTCAE v4.03|For the intensive study, the plasma trough concentration (Ctrough) will be analyzed|QTc interval|PROs as measured by Patient Global Impression of Change (PGIC)|Patient Reported Outcomes (PROs) as measured by EuroQoL 5 Dimension questionnaire 5-Level version (EQ-5D-5L)|Patient Reported Outcomes (PROs) as measured by Patient Global Impression of Symptoms (PGIS)|Complete Remission with incomplete hematologic recovery (CRi)|Rate of morphological leukemia-free state (MLFS)|Rate of Partial Remission (PR)|Rate of Complete Remission with partial hematological recovery (CRh) for the Non-intensive study only only|Minimum Observed Plasma Trough Concentratrion of glasdegib in the Intensive Study|Minimum Observed Plasma Trough Concentration of glasdegib in the Non-intensive study","Scale is from 0-10 where 0 is not present and 10 is as bad as you can image.|Response as defined by the 2017 European LeukemiaNet (ELN) recommendations.|5 years after last subject randomized, consent withdrawal, or death|Measurement Scale from 0-10.|PK samples taken on Induction(s) Day 1 (1 and 4 hours post induction); Induction(s) Day 10 (pre-dose, 1 and 4 hours post dose); Day 1 of each Consolidation cycle (pre-dose, 1 and 4 hours post dose)|One question asking for description of leukemia symptoms.|Series of questions that ask for information that best describes health.|One question asking for information regarding leukemia symptoms.|Its the minimum trough concentration in plasma of glasdegib following multiple daily dosing to steady state.|It is the minimum trough concentration in plasma of glasdegib following multiple daily dosing to steady state.","5 years after last subject randomized, consent withdrawal, or death|2 years after last dose of study therapy|5 years after last patient randomized, withdrawal, or death|5 years after last subject randomized, withdrawal, or death|Day 10 of Induction Cycle and Day 1 of each Consolidation Cycle|Cycle 1 Day 15 and Cycles 2 and 3 on Day 1","ClinicalTrials.gov_Inquiries@pfizer.com","Pfizer CT.gov Call Center","1-800-718-1021","Darlinghurst, New South Wales, Australia, 2010|Brno, Czechia, 625 00 Nemocnicni LekarnaBrno, Czechia, 625 00 InternÃ­ HematologickÃ¡ Klinika, Fakultni Nemocnice KrÃ¡lovskÃ© VinohradyPraha 10, Czechia, 100 34 Ãšstavni LÃ©kÃ¡rnaPraha 10, Czechia, 100 34|Nagoya, Aichi, Japan, 466-8650|Akita, Japan, 010-8543 Kyushu University HospitalFukuoka, Japan, 812-8582 National Hospital Organization Kumamoto Medical CenterKumamoto, Japan, 860-0008 Nagasaki University HospitalNagasaki, Japan, 852-8501 Tokyo Medical University HospitalTokyo, Japan, 160-0023 Korea, Republic Of, Jeollabuk-Do Chonbuk National University HospitalJeonju-Si, Jeollabuk-Do, Korea, Republic Of, 54907 Korea, Republic Of, Jeollanam-Do Chonnam National University Hwasun HospitalHwasun-Gun, Jeollanam-Do, Korea, Republic Of, 58128 Korea, Republic Of Department Of Pharmacy, Inje University Busan Paik HospitalBusan, Korea, Republic Of, 47392 Inje University Busan Paik HospitalBusan, Korea, Republic Of, 47392 Clinical Trial Pharmacy, Keimyung University Dongsan HospitalDaegu, Korea, Republic Of, 41931 Keimyung University Dongsan HospitalDaegu, Korea, Republic Of, 41931 Gachon University Gil Medical CenterIncheon, Korea, Republic Of, 21565 Seoul National University HospitalSeoul, Korea, Republic Of, 03080 Clinical Trial Center, Severance Hospital, Yonsei University Health System (Drug Shipment Only)Seoul, Korea, Republic Of, 03722 Severance Hospital, Yonsei University Health SystemSeoul, Korea, Republic Of, 03722 Department Of Pharmacy, Samsung Medical CenterSeoul, Korea, Republic Of, 06351 Samsung Medical CenterSeoul, Korea, Republic Of, 06351 The Catholic University Of Korea Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591 The Catholic University Of Korea, Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591|Yoshida-Gun, Fukui, Japan, 910-1193|Maebashi, Gunma, Japan, 371-8511|Kobe-Shi, Hyogo, Japan, 650-0017|Yokohama, Kanagawa, Japan, 232-0024|Sendai, Miyagi, Japan, 980-8574|Osaka-City, Osaka, Japan, 545-8586 Kindai University HospitalOsaka-Sayama, Osaka, Japan, 589-8511|Sunto-Gun, Shizuoka, Japan, 411-8777|Tachikawa, Tokyo, Japan, 190-0014|Gdansk, Poland, 80-952|Craiova, Dolj, Romania, 200143|Bucuresti, Romania, 030171 Russian Federation Sbhi Cch No. 40 Hd MoscowMoscow, Russian Federation, 129301 State Budgetary Healthcare Institution Of MoscowMoscow, Russian Federation, 129301 State Budgetary Institution Of Ryazan Region 'Regional Clinical Hospital' (Sbi Rr Rch)Ryazan, Russian Federation, 390039 Drug Shipment Address:Saint Petersburg, Russian Federation, 191024 Fsbi Russrhti Fmba Of|Barcelona, Spain, 08003 Hospital De La Santa Creu I Sant PauBarcelona, Spain, 08025 Hospital Universitario Arnau De VilanovaLleida, Spain, 25198 Hospital General Universitario Gregorio MaranonMadrid, Spain, 28007 Hospital Universitario Ramon Y CajalMadrid, Spain, 28034 Hospital Universitario Virgen Del RocioSevilla, Spain, 41013 Hospital Universitari I Politecnic La FeValencia, Spain, 46026 Taiwan Department Of Clinical Trial Pharmacy, Taipei Veterans General HospitalTaipei, Taiwan, 11217 Taipei Veterans General HospitalTaipei, Taiwan, 11217 Division Of Pharmacy, Koo Foundation Sun Yat-Sen Cancer CenterTaipei, Taiwan, 112 Koo Foundation Sun Yat-Sen Cancer CenterTaipei, Taiwan, 112 Chang Gung Memorial Hospital-Linkou BranchTaoyuan City, Taiwan, 333 Chemotherapy Pharmacy, Chang Gung Memorial Hospital-Linkou BranchTaoyuan City, Taiwan, 333|Sutton, Surrey, United Kingdom, Sm2 5Pt|Los Angeles, California, United States, 90095 Ucla Department Of MedicineLos Angeles, California, United States, 90095 Ucla Hematology/Oncology ClinicLos Angeles, California, United States, 90095 Ucla Ronald Reagan Medical CenterLos Angeles, California, United States, 90095 Uc Irvine Health - Chao Family Comprehensive Cancer CenterOrange, California, United States, 92868-3201 Uc Irvine Medical CenterOrange, California, United States, 92868-3201 Ucsf Helen Diller Family Comprehensive Cancer CenterSan Francisco, California, United States, 94143 University Of California, San Francisco Medical CenterSan Francisco, California, United States, 94143 University Of California, San FranciscoSan Francisco, California, United States, 94143|Kansas City, Missouri, United States, 64132|Lake Success, New York, United States, 11042 North Shore University HospitalManhasset, New York, United States, 11030 Long Island Jewish Medical CenterNew Hyde Park, New York, United States, 11040 University Of Rochester Cancer Center PharmacyRochester, New York, United States, 14642 University Of Rochester Medical CenterRochester, New York, United States, 14642|Cleveland, Ohio, United States, 44106 University Hospitals Cleveland Medical CenterCleveland, Ohio, United States, 44106 Cleveland Clinic FoundationCleveland, Ohio, United States, 44195|Nashville, Tennessee, United States, 37203|Dallas, Texas, United States, 75246 Baylor University Medical CenterDallas, Texas, United States, 75246 Blood Cancer And Stem Cell Transplant ClinicSan Antonio, Texas, United States, 78229 Methodist Healthcare System Of San AntonioSan Antonio, Texas, United States, 78229 Methodist Hospital Investigational PharmacySan Antonio, Texas, United States, 78229|Seattle, Washington, United States, 98104 Swedish Investigational Drug Services PharmacySeattle, Washington, United States, 98104 Swedish Medical CenterSeattle, Washington, United States, 98122","California|Missouri|New York|Ohio|Tennessee|Texas|Washington","Australia|Czechia|Japan|Poland|Romania|Spain|United Kingdom|United States","New South Wales St Vincent's Hospital Sydney|Interni Hematologicka A Onkologicka Klinika, Fakultni Nemocnice Brno|Aichi Japanese Red Cross Nagoya Daini Hospital|Akita University Hospital|Fukui University Of Fukui Hospital|Gunma Gunma University Hospital|Hyogo Kobe University Hospital|Kanagawa Yokohama City University Medical Center|Miyagi Tohoku University Hospital|Osaka Osaka City University Hospital|Shizuoka Shizuoka Cancer Center|Tokyo National Hospital Organization Disaster Medical Center|Klinika Hematologii I Transplantologii Uniwersyteckie Centrum Kliniczne|Dolj Spitalul Clinic Municipal Filantropia Craiova, Sectia Clinica Hematologie|Spitalul Clinic Coltea, Clinica De Hematologie|Hospital Del Mar|, Surrey The Royal Marsden Nhs Foundation Trust|Rrmc - Ucla|Midamerica Division, Inc., C/O Research Medical Center|Northwell Health Monter Cancer Center|Taussig Cancer Center Investigational Pharmacy|The Sarah Cannon Research Institute|Baylor Scott And White Research Institute|Swedish Cancer Institute",{"$nulls":3},"Pfizer CT.gov Call Center","2018-11-03","2020-05-25T16:39:30.058","2020-05-26T17:10:42.972","NCT03416179"]
["5ecbf4c2307e3d1b1f8d9e47","NCT03416179","2018-11-20","Pfizer","PFE","Recruiting","A Study Evaluating Intensive Chemotherapy With or Without Glasdegib or Azacitidine With or Without Glasdegib In Patients With Previously Untreated Acute Myeloid Leukemia (BRIGHT AML1019)","Glasdegib|Cytarabine|Daunorubicin|Azacitidine","Hh Inhibitor|DNA Polymerase Inhibitor|Nucleic Acid Synthesis Inhibitor|TOP2 Inhibitor|DNA Mtase Inhibitor","Yes","['Glasdegib']","Unknown",null,"Phase 3",4,720,"Anticipated","2018-04-20","2021-06-13","OS","Overall Survival",{"$nulls":3},"Glasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).\n\nGlasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).","Two separate registration trials conducted under one protocol number are proposed to adequately and independently evaluate the addition of glasdegib in intensive and non-intensive chemotherapy populations. Each study will have an experimental treatment arm and a placebo arm. Endpoints are the same for each study except where specifically indicated.\n\nAssignment to the Intensive Study or the Non-Intensive Study will be made by the Investigator based on the 2017 European LeukemiaNet (ELN) recommendations.\n\nStudy B1371019 is a randomized (1:1), double-blind, multi-center, placebo controlled study of chemotherapy in combination with glasdegib versus chemotherapy in combination with placebo in adult patients with previously untreated AML.\n\nGlasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).\n\nGlasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).","A RANDOMIZED (1:1), DOUBLE-BLIND, MULTI-CENTER, PLACEBO CONTROLLED STUDY EVALUATING INTENSIVE CHEMOTHERAPY WITH OR WITHOUT GLASDEGIB (PF-04449913) OR AZACITIDINE (AZA) WITH OR WITHOUT GLASDEGIB IN PATIENTS WITH PREVIOUSLY UNTREATED ACUTE MYELOID LEUKEMIA","B1371019","Leukemia, Myeloid, Acute","Acute Leukemia|Acute Myeloid Leukemia|Myeloid Leukemia|Leukemia","Oncology Hematological","Oncology","Experimental|Placebo Comparator","Arm A (Intensive Study)|Arm B (Intensive Study)|Arm A (Non-intensive study)|Arm B (Non-intensive study)","Glasdegib + '7+3' Induction(s)|Placebo + '7+3' Induction(s)|Glasdegib + azacitidine|Placebo + azacitidine","Drug|Procedure","glasdegib|daunorubicin + cytarabine|cytarabine|HSCT|Placebo|azacitidine","Daily Glasdegib (100 mg, PO), beginning on Day 1 and is to continue up to 2 years post randomization.\n\nFollowing consolidation therapy, glasdegib or placebo will be administered daily for up to 2 years after randomization or until they have minimal residual disease (MRD) negative disease, whichever comes first.\n\nDaily Glasdegib (100 mg, PO) or matching placebo will continue throughout Induction(s) and Consolidation therapies regardless of dose modifications/delays in the chemotherapy.|Consolidation with single agent cytarabine 3 g/m2 IV for adults <60 years and 1 g/m2 for adults 60 years over 3 BID on Days 1, 3, and 5, every 28 days for up to 4 cycles or alternative single agent cytarabine consolidation schedules may be used per local prescribing information.|If required, and done per standard of care post Induction(s).|Azacitidine (75 mg/m2, SC or IV) daily for 7 days, in 28 day cycles for as long as they do not meet the criteria for disease progression, unacceptable toxicity, consent withdrawal, or death.|Matching placebo (PO) is to be administered by mouth daily beginning on Day 1 of chemotherapy and will continue if subjects demonstrate reasonable evidence of clinical benefit and do not meet the criteria for progression regardless of any delays/modifications in the chemotherapy treatment. Subjects will continue placebo until disease progression, unacceptable toxicity, consent withdrawal, or death, whichever comes first.","PF-04449913","Arm A (Intensive Study)|Arm B (Intensive Study)|Arm A (Non-intensive study)|Arm B (Non-intensive study)","\n\nSubjects must meet all of the following inclusion criteria to be eligible for enrollment into the Intensive and Non Intensive study (unless where indicated):\n\n 1.  Subjects with untreated AML according to the World Health Organization (WHO) 2016 Classification2, including those with: * AML arising from MDS or another antecedent hematologic disease (AHD).\n      * AML after previous cytotoxic therapy or radiation (secondary AML).\n     \n     \n 2.  18 years of age (In Japan, 20 years of age).\n 3.  Adequate Organ Function as defined by the following: * Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) 3 x upper limit of normal (ULN), excluding subjects with liver function abnormalities due to underlying malignancy.\n      * Total serum bilirubin 2 x ULN (except subjects with documented Gilbert's syndrome).\n      * Estimated creatinine clearance 30 mL/min as calculated using the standard method for the institution.\n     \n     \n 4.  QTc interval 470 msec using the Fridericia correction (QTcF).\n 5.  All anti cancer treatments (unless specified) should be discontinued 2 weeks from study entry, for example: targeted chemotherapy, radiotherapy, investigational agents, hormones, anagrelide or cytokines. * For control of rapidly progressing leukemia, all trans retinoic acid (ATRA), hydroxyurea, and/or leukopheresis may be used before and for up to 1 week after the first dose of glasdegib.\n     \n     \n 6.  Serum or urine pregnancy test (for female subjects of childbearing potential) with a minimum sensitivity of 25 IU/L or equivalent units of human chorionic gonadotropin (hCG) negative at screening.\n 7.  Male and female subjects of childbearing potential and at risk for pregnancy must agree to use at least one highly effective method of contraception throughout the study and for 180 days after the last dose of azacitidine, cytarabine, or daunorubicin; and the last dose of glasdegib or placebo, whichever occurs later.\n 8.  Female subjects of non childbearing potential must meet at least 1 of the following criteria: 1. Have undergone a documented hysterectomy and/or bilateral oophorectomy;\n      2. Have medically confirmed ovarian failure; or\n      3. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; status may be confirmed by having a serum follicle stimulating hormone (FSH) level confirming the postmenopausal state.\n     \n     All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential.\n     \n     \n 9.  Consent to a saliva sample collection for a germline comparator, unless prohibited by local regulations or ethics committee (EC) decision.\n 10. Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.\n 11. Subjects who are willing and able to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures (including bone marrow [BM] assessments).\n\n","\n\nSubjects with any of the following characteristics/conditions will not be included in the study:\n\n 1.  Acute Promyelocytic Leukemia (APL) and APLwith PML RARA, subjects (WHO 2016 classification).\n 2.  AML with BCR ABL1 or t(9;22)(q34;q11.2) as a sole abnormality. * Complex genetics may include t(9;22) cytogenetic translocation.\n     \n     \n 3.  Subjects with known active CNS leukemia.\n 4.  Participation in other clinical studies involving other investigational drug(s) (Phases 1 4) within 4 weeks prior study entry and/or during study participation.\n 5.  Subjects known to be refractory to platelet or packed red cell transfusions per Institutional Guidelines, or a patient who refuses blood product support.\n 6.  Subjects with another active malignancy on treatment with the exception of basal cell carcinoma, non melanoma skin cancer, cervical carcinoma in situ. Other prior or concurrent malignancies will be considered on a case by case basis.\n 7.  Any one of the following ongoing or in the previous 6 months: myocardial infarction, congenital long QT syndrome, Torsades de pointes, symptomatic arrhythmias (including sustained ventricular tachyarrhythmia), right or left bundle branch block and bifascicular block, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (CHF New York Heart Association class III or IV), cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism; as well as bradycardia defined as <50 bpms.\n 8.  Subjects with an active, life threatening or clinically significant uncontrolled systemic infection not related to AML.\n 9.  Subjects with left ventricular ejection fraction (LVEF) <50% are excluded from the Intensive Chemotherapy Study only.\n 10. Cumulative anthracycline dose equivalent of 550 mg/m2 of daunorubicin for the Intensive Chemotherapy Study only.\n 11. Known malabsorption syndrome or other condition that may significantly impair absorption of study medication in the investigator's judgment (eg, gastrectomy, lap band, Crohn's disease) and inability or unwillingness to swallow tablets or capsules.\n 12. Current use or anticipated requirement for drugs that are known strong CYP3A4/5 inducers.\n 13. Concurrent administration of herbal preparations.\n 14. Major surgery or radiation within 4 weeks of starting study treatment.\n 15. Documented or suspected hypersensitivity to any one of the following: * For subjects assigned to intensive chemotherapy, documented or suspected hypersensitivity to cytarabine (not including drug fever or exanthema, including known cerebellar side effects) or daunorubicin.\n      * For subjects assigned to non intensive chemotherapy, documented or suspected hypersensitivity to azacitidine or mannitol.\n     \n     \n 16. Known active drug or alcohol abuse.\n 17. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.\n 18. Pregnant females or breastfeeding female subjects.\n 19. Known recent or active suicidal ideation or behavior.\n 20. Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.","FSH",null,"Protein","Ovary","Actual","2018-01-31","Actual","Anticipated","2025-07-22","Anticipated","2018-11-01","2017-12-21","2018-01-23","2018-11-17","Yes","glasdegib;\nuntreated;\nHedgehog Inhibitor","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"All",null,"No","Yes\nInformation relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests",null,"URL: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1371019&StudyName=A+Randomized+%281%3A1%29%2C+Double+Blind%2C+Multi+Center%2C+Placebo+Controlled+Study+Evaluating+Intensive+Chemotherapy+With+Or+Without+Glasdegib+%28pf+04449913%29+Or+Azacitidine+%28aza%29+With+Or+Without+Glasdegib+In+Patients+With+Previously+Untreated+Acute+Myeloid+Leukemia [https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1371019&StudyName=A+Randomized+%281%3A1%29%2C+Double+Blind%2C+Multi+Center%2C+Placebo+Controlled+Study+Evaluating+Intensive+Chemotherapy+With+Or+Without+Glasdegib+%28pf+04449913%29+Or+Azacitidine+%28aza%29+With+Or+Without+Glasdegib+In+Patients+With+Previously+Untreated+Acute+Myeloid+Leukemia] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To obtain contact information for a study center near you, click here.",null,"Yes","No",{"$nulls":17},"2017-002822-19|BRIGHT|BRIGHT AML1019","EudraCT Number|Alias Study Number","Overall survival","5 years after last subject randomized",null,"Fatigue score measured by the MD Anderson Symptom Inventory (MDASI)-AML/MDS questionnaire|Rate of Complete Remission (CR) (including CR with minimal residual disease (MRD)-negative as assessed by multiparametric flow cytometry)|Duration of response (defined as CR [includes CR-MRD negative]/CRi or CR/CRh as appropriate)|Time to response (CR[includes CR-MRD negative)]/CR with partial hematologic rcovery (CRh) as appropriate)|Event-free Survival|Patient Reported Outcomes (PROs) as measured by the M.D. Anderson Symptom Inventory AML/MDS Module (MDASI-AML/MDS)|Adverse events as graded by NCI CTCAE v4.03|Laboratory abnormalities as graded by NCI CTCAE v4.03|For the intensive study, the plasma trough concentration (Ctrough) will be analyzed|QTc interval|PROs as measured by Patient Global Impression of Change (PGIC)|Patient Reported Outcomes (PROs) as measured by EuroQoL 5 Dimension questionnaire 5-Level version (EQ-5D-5L)|Patient Reported Outcomes (PROs) as measured by Patient Global Impression of Symptoms (PGIS)|Complete Remission with incomplete hematologic recovery (CRi)|Rate of morphological leukemia-free state (MLFS)|Rate of Partial Remission (PR)|Rate of Complete Remission with partial hematological recovery (CRh) for the Non-intensive study only only|Minimum Observed Plasma Trough Concentratrion of glasdegib in the Intensive Study|Minimum Observed Plasma Trough Concentration of glasdegib in the Non-intensive study","Scale is from 0-10 where 0 is not present and 10 is as bad as you can image.|Response as defined by the 2017 European LeukemiaNet (ELN) recommendations.|5 years after last subject randomized, consent withdrawal, or death|Measurement Scale from 0-10.|PK samples taken on Induction(s) Day 1 (1 and 4 hours post induction); Induction(s) Day 10 (pre-dose, 1 and 4 hours post dose); Day 1 of each Consolidation cycle (pre-dose, 1 and 4 hours post dose)|One question asking for description of leukemia symptoms.|Series of questions that ask for information that best describes health.|One question asking for information regarding leukemia symptoms.|Its the minimum trough concentration in plasma of glasdegib following multiple daily dosing to steady state.|It is the minimum trough concentration in plasma of glasdegib following multiple daily dosing to steady state.","5 years after last subject randomized, consent withdrawal, or death|2 years after last dose of study therapy|5 years after last patient randomized, withdrawal, or death|5 years after last subject randomized, withdrawal, or death|Day 10 of Induction Cycle and Day 1 of each Consolidation Cycle|Cycle 1 Day 15 and Cycles 2 and 3 on Day 1","ClinicalTrials.gov_Inquiries@pfizer.com","Pfizer CT.gov Call Center","1-800-718-1021","Darlinghurst, New South Wales, Australia, 2010|Brno, Czechia, 625 00 Nemocnicni LekarnaBrno, Czechia, 625 00 InternÃ­ HematologickÃ¡ Klinika, Fakultni Nemocnice KrÃ¡lovskÃ© VinohradyPraha 10, Czechia, 100 34 Ãšstavni LÃ©kÃ¡rnaPraha 10, Czechia, 100 34|Creteil, France, 94010 Chu Henri MondorCrÃ©teil, France, 94010 Hopital Saint LouisParis, France, 75010 Centre Hospitalier Lyon Sud -Unite De Pharmacie Clinique OncologiquePierre Benite Cedex, France, 69495 Centre Hospitalier Lyon Sud - Service D'HematologiePierre Benite Cedex, France, 69495|Haifa, Israel, 3109601 Shaare Zedek Medical CanterJerusalem, Israel, 9103102 Shaare Zedek Medical CenterJerusalem, Israel, 9103102 Hadassah Medical CenterJerusalem, Israel, 91120 Belinson Mc, Davidof Cancer Center- Hematology DepartmentPetach Tikva, Israel, 49100 Tel-Aviv Sourasky Medical CenterTel Aviv, Israel, 6423906|Nagoya, Aichi, Japan, 466-8650|Akita, Japan, 010-8543 Kyushu University HospitalFukuoka, Japan, 812-8582 National Hospital Organization Kumamoto Medical CenterKumamoto, Japan, 860-0008 Nagasaki University HospitalNagasaki, Japan, 852-8501 Tokyo Medical University HospitalTokyo, Japan, 160-0023 Korea, Republic Of, Jeollabuk-Do Chonbuk National University HospitalJeonju-Si, Jeollabuk-Do, Korea, Republic Of, 54907 Korea, Republic Of, Jeollanam-Do Chonnam National University Hwasun HospitalHwasun-Gun, Jeollanam-Do, Korea, Republic Of, 58128 Korea, Republic Of Department Of Pharmacy, Inje University Busan Paik HospitalBusan, Korea, Republic Of, 47392 Inje University Busan Paik HospitalBusan, Korea, Republic Of, 47392 Clinical Trial Pharmacy, Keimyung University Dongsan HospitalDaegu, Korea, Republic Of, 41931 Keimyung University Dongsan HospitalDaegu, Korea, Republic Of, 41931 Gachon University Gil Medical CenterIncheon, Korea, Republic Of, 21565 Seoul National University HospitalSeoul, Korea, Republic Of, 03080 Clinical Trial Center, Severance Hospital, Yonsei University Health System (Drug Shipment Only)Seoul, Korea, Republic Of, 03722 Severance Hospital, Yonsei University Health SystemSeoul, Korea, Republic Of, 03722 Department Of Pharmacy, Samsung Medical CenterSeoul, Korea, Republic Of, 06351 Samsung Medical CenterSeoul, Korea, Republic Of, 06351 The Catholic University Of Korea Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591 The Catholic University Of Korea, Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591|Yoshida-Gun, Fukui, Japan, 910-1193|Maebashi, Gunma, Japan, 371-8511|Kobe-Shi, Hyogo, Japan, 650-0017|Yokohama, Kanagawa, Japan, 232-0024|Sendai, Miyagi, Japan, 980-8574|Osaka-City, Osaka, Japan, 545-8586 Kindai University HospitalOsaka-Sayama, Osaka, Japan, 589-8511|Sunto-Gun, Shizuoka, Japan, 411-8777|Tachikawa, Tokyo, Japan, 190-0014|Gdansk, Poland, 80-952|Craiova, Dolj, Romania, 200143|Bucuresti, Romania, 030171 Russian Federation Sbhi Cch No. 40 Hd MoscowMoscow, Russian Federation, 129301 State Budgetary Healthcare Institution Of MoscowMoscow, Russian Federation, 129301 Sbhi Nnr Nn Rch N. A. N.A. SemashkoNizhniy Novgorod, Russian Federation, 603126 State Budgetary Institution Of Ryazan Region 'Regional Clinical Hospital' (Sbi Rr Rch)Ryazan, Russian Federation, 390039 Drug Shipment Address:Saint Petersburg, Russian Federation, 191024 Fsbi Russrhti Fmba Of|Barcelona, Spain, 08003 Hospital De La Santa Creu I Sant PauBarcelona, Spain, 08025 Hospital Universitario Arnau De VilanovaLleida, Spain, 25198 Hospital General Universitario Gregorio MaranonMadrid, Spain, 28007 Hospital Universitario Ramon Y CajalMadrid, Spain, 28034 Hospital Universitario Virgen Del RocioSevilla, Spain, 41013 Hospital Universitari I Politecnic La FeValencia, Spain, 46026 Taiwan Department Of Clinical Trial Pharmacy, Taipei Veterans General HospitalTaipei, Taiwan, 11217 Taipei Veterans General HospitalTaipei, Taiwan, 11217 Division Of Pharmacy, Koo Foundation Sun Yat-Sen Cancer CenterTaipei, Taiwan, 112 Koo Foundation Sun Yat-Sen Cancer CenterTaipei, Taiwan, 112 Chang Gung Memorial Hospital-Linkou BranchTaoyuan City, Taiwan, 333 Chemotherapy Pharmacy, Chang Gung Memorial Hospital-Linkou BranchTaoyuan City, Taiwan, 333|Sutton, Surrey, United Kingdom, Sm2 5Pt|Los Angeles, California, United States, 90095 Ucla Department Of MedicineLos Angeles, California, United States, 90095 Ucla Hematology/Oncology ClinicLos Angeles, California, United States, 90095 Ucla Ronald Reagan Medical CenterLos Angeles, California, United States, 90095 Uc Irvine Health - Chao Family Comprehensive Cancer CenterOrange, California, United States, 92868-3201 Uc Irvine Medical CenterOrange, California, United States, 92868-3201 Ucsf Helen Diller Family Comprehensive Cancer CenterSan Francisco, California, United States, 94143 University Of California, San Francisco Medical CenterSan Francisco, California, United States, 94143 University Of California, San FranciscoSan Francisco, California, United States, 94143|Kansas City, Missouri, United States, 64132|Lake Success, New York, United States, 11042 North Shore University HospitalManhasset, New York, United States, 11030 Long Island Jewish Medical CenterNew Hyde Park, New York, United States, 11040 University Of Rochester Cancer Center PharmacyRochester, New York, United States, 14642 University Of Rochester Medical CenterRochester, New York, United States, 14642|Cleveland, Ohio, United States, 44106 University Hospitals Cleveland Medical CenterCleveland, Ohio, United States, 44106 Cleveland Clinic FoundationCleveland, Ohio, United States, 44195|Nashville, Tennessee, United States, 37203|Dallas, Texas, United States, 75246 Baylor University Medical CenterDallas, Texas, United States, 75246 Blood Cancer And Stem Cell Transplant ClinicSan Antonio, Texas, United States, 78229 Methodist Healthcare System Of San AntonioSan Antonio, Texas, United States, 78229 Methodist Hospital Investigational PharmacySan Antonio, Texas, United States, 78229|Seattle, Washington, United States, 98104 Swedish Investigational Drug Services PharmacySeattle, Washington, United States, 98104 Swedish Medical CenterSeattle, Washington, United States, 98122","California|Missouri|New York|Ohio|Tennessee|Texas|Washington","Australia|Czechia|France|Israel|Japan|Poland|Romania|Spain|United Kingdom|United States","New South Wales St Vincent's Hospital Sydney|Interni Hematologicka A Onkologicka Klinika, Fakultni Nemocnice Brno|Chu Henri Mondor|Rambam Health Care Campus|Aichi Japanese Red Cross Nagoya Daini Hospital|Akita University Hospital|Fukui University Of Fukui Hospital|Gunma Gunma University Hospital|Hyogo Kobe University Hospital|Kanagawa Yokohama City University Medical Center|Miyagi Tohoku University Hospital|Osaka Osaka City University Hospital|Shizuoka Shizuoka Cancer Center|Tokyo National Hospital Organization Disaster Medical Center|Klinika Hematologii I Transplantologii Uniwersyteckie Centrum Kliniczne|Dolj Spitalul Clinic Municipal Filantropia Craiova, Sectia Clinica Hematologie|Spitalul Clinic Coltea, Clinica De Hematologie|Hospital Del Mar|, Surrey The Royal Marsden Nhs Foundation Trust|Rrmc - Ucla|Midamerica Division, Inc., C/O Research Medical Center|Northwell Health Monter Cancer Center|Taussig Cancer Center Investigational Pharmacy|The Sarah Cannon Research Institute|Baylor Scott And White Research Institute|Swedish Cancer Institute",{"$nulls":3},"Pfizer CT.gov Call Center","2018-11-17","2020-05-25T16:39:30.524","2020-05-26T17:10:42.972","NCT03416179"]
["5ecbf4c2fe30261b1a0483b6","NCT03416179","2018-11-26","Pfizer","PFE","Recruiting","A Study Evaluating Intensive Chemotherapy With or Without Glasdegib or Azacitidine With or Without Glasdegib In Patients With Previously Untreated Acute Myeloid Leukemia (BRIGHT AML1019)","Glasdegib|Cytarabine|Daunorubicin|Azacitidine","Hh Inhibitor|DNA Polymerase Inhibitor|Nucleic Acid Synthesis Inhibitor|TOP2 Inhibitor|DNA Mtase Inhibitor","Unknown",null,"Unknown",null,"Phase 3",4,720,"Anticipated","2018-04-20","2021-06-13","OS","Overall Survival",{"$nulls":3},"Glasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).\n\nGlasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).","Two separate registration trials conducted under one protocol number are proposed to adequately and independently evaluate the addition of glasdegib in intensive and non-intensive chemotherapy populations. Each study will have an experimental treatment arm and a placebo arm. Endpoints are the same for each study except where specifically indicated.\n\nAssignment to the Intensive Study or the Non-Intensive Study will be made by the Investigator based on the 2017 European LeukemiaNet (ELN) recommendations.\n\nStudy B1371019 is a randomized (1:1), double-blind, multi-center, placebo controlled study of chemotherapy in combination with glasdegib versus chemotherapy in combination with placebo in adult patients with previously untreated AML.\n\nGlasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).\n\nGlasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).","A RANDOMIZED (1:1), DOUBLE-BLIND, MULTI-CENTER, PLACEBO CONTROLLED STUDY EVALUATING INTENSIVE CHEMOTHERAPY WITH OR WITHOUT GLASDEGIB (PF-04449913) OR AZACITIDINE (AZA) WITH OR WITHOUT GLASDEGIB IN PATIENTS WITH PREVIOUSLY UNTREATED ACUTE MYELOID LEUKEMIA","B1371019","Leukemia, Myeloid, Acute","Acute Leukemia|Acute Myeloid Leukemia|Myeloid Leukemia|Leukemia","Oncology Hematological","Oncology","Experimental|Placebo Comparator","Arm A (Intensive Study)|Arm B (Intensive Study)|Arm A (Non-intensive study)|Arm B (Non-intensive study)","Glasdegib + '7+3' Induction(s)|Placebo + '7+3' Induction(s)|Glasdegib + azacitidine|Placebo + azacitidine","Drug|Procedure","glasdegib|daunorubicin + cytarabine|cytarabine|HSCT|Placebo|azacitidine","Daily Glasdegib (100 mg, PO), beginning on Day 1 and is to continue up to 2 years post randomization.\n\nFollowing consolidation therapy, glasdegib or placebo will be administered daily for up to 2 years after randomization or until they have minimal residual disease (MRD) negative disease, whichever comes first.\n\nDaily Glasdegib (100 mg, PO) or matching placebo will continue throughout Induction(s) and Consolidation therapies regardless of dose modifications/delays in the chemotherapy.|Consolidation with single agent cytarabine 3 g/m2 IV for adults <60 years and 1 g/m2 for adults 60 years over 3 BID on Days 1, 3, and 5, every 28 days for up to 4 cycles or alternative single agent cytarabine consolidation schedules may be used per local prescribing information.|If required, and done per standard of care post Induction(s).|Azacitidine (75 mg/m2, SC or IV) daily for 7 days, in 28 day cycles for as long as they do not meet the criteria for disease progression, unacceptable toxicity, consent withdrawal, or death.|Matching placebo (PO) is to be administered by mouth daily beginning on Day 1 of chemotherapy and will continue if subjects demonstrate reasonable evidence of clinical benefit and do not meet the criteria for progression regardless of any delays/modifications in the chemotherapy treatment. Subjects will continue placebo until disease progression, unacceptable toxicity, consent withdrawal, or death, whichever comes first.","PF-04449913","Arm A (Intensive Study)|Arm B (Intensive Study)|Arm A (Non-intensive study)|Arm B (Non-intensive study)","\n\nSubjects must meet all of the following inclusion criteria to be eligible for enrollment into the Intensive and Non Intensive study (unless where indicated):\n\n 1.  Subjects with untreated AML according to the World Health Organization (WHO) 2016 Classification2, including those with: * AML arising from MDS or another antecedent hematologic disease (AHD).\n      * AML after previous cytotoxic therapy or radiation (secondary AML).\n     \n     \n 2.  18 years of age (In Japan, 20 years of age).\n 3.  Adequate Organ Function as defined by the following: * Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) 3 x upper limit of normal (ULN), excluding subjects with liver function abnormalities due to underlying malignancy.\n      * Total serum bilirubin 2 x ULN (except subjects with documented Gilbert's syndrome).\n      * Estimated creatinine clearance 30 mL/min as calculated using the standard method for the institution.\n     \n     \n 4.  QTc interval 470 msec using the Fridericia correction (QTcF).\n 5.  All anti cancer treatments (unless specified) should be discontinued 2 weeks from study entry, for example: targeted chemotherapy, radiotherapy, investigational agents, hormones, anagrelide or cytokines. * For control of rapidly progressing leukemia, all trans retinoic acid (ATRA), hydroxyurea, and/or leukopheresis may be used before and for up to 1 week after the first dose of glasdegib.\n     \n     \n 6.  Serum or urine pregnancy test (for female subjects of childbearing potential) with a minimum sensitivity of 25 IU/L or equivalent units of human chorionic gonadotropin (hCG) negative at screening.\n 7.  Male and female subjects of childbearing potential and at risk for pregnancy must agree to use at least one highly effective method of contraception throughout the study and for 180 days after the last dose of azacitidine, cytarabine, or daunorubicin; and the last dose of glasdegib or placebo, whichever occurs later.\n 8.  Female subjects of non childbearing potential must meet at least 1 of the following criteria: 1. Have undergone a documented hysterectomy and/or bilateral oophorectomy;\n      2. Have medically confirmed ovarian failure; or\n      3. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; status may be confirmed by having a serum follicle stimulating hormone (FSH) level confirming the postmenopausal state.\n     \n     All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential.\n     \n     \n 9.  Consent to a saliva sample collection for a germline comparator, unless prohibited by local regulations or ethics committee (EC) decision.\n 10. Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.\n 11. Subjects who are willing and able to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures (including bone marrow [BM] assessments).\n\n","\n\nSubjects with any of the following characteristics/conditions will not be included in the study:\n\n 1.  Acute Promyelocytic Leukemia (APL) and APLwith PML RARA, subjects (WHO 2016 classification).\n 2.  AML with BCR ABL1 or t(9;22)(q34;q11.2) as a sole abnormality. * Complex genetics may include t(9;22) cytogenetic translocation.\n     \n     \n 3.  Subjects with known active CNS leukemia.\n 4.  Participation in other clinical studies involving other investigational drug(s) (Phases 1 4) within 4 weeks prior study entry and/or during study participation.\n 5.  Subjects known to be refractory to platelet or packed red cell transfusions per Institutional Guidelines, or a patient who refuses blood product support.\n 6.  Subjects with another active malignancy on treatment with the exception of basal cell carcinoma, non melanoma skin cancer, cervical carcinoma in situ. Other prior or concurrent malignancies will be considered on a case by case basis.\n 7.  Any one of the following ongoing or in the previous 6 months: myocardial infarction, congenital long QT syndrome, Torsades de pointes, symptomatic arrhythmias (including sustained ventricular tachyarrhythmia), right or left bundle branch block and bifascicular block, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (CHF New York Heart Association class III or IV), cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism; as well as bradycardia defined as <50 bpms.\n 8.  Subjects with an active, life threatening or clinically significant uncontrolled systemic infection not related to AML.\n 9.  Subjects with left ventricular ejection fraction (LVEF) <50% are excluded from the Intensive Chemotherapy Study only.\n 10. Cumulative anthracycline dose equivalent of 550 mg/m2 of daunorubicin for the Intensive Chemotherapy Study only.\n 11. Known malabsorption syndrome or other condition that may significantly impair absorption of study medication in the investigator's judgment (eg, gastrectomy, lap band, Crohn's disease) and inability or unwillingness to swallow tablets or capsules.\n 12. Current use or anticipated requirement for drugs that are known strong CYP3A4/5 inducers.\n 13. Concurrent administration of herbal preparations.\n 14. Major surgery or radiation within 4 weeks of starting study treatment.\n 15. Documented or suspected hypersensitivity to any one of the following: * For subjects assigned to intensive chemotherapy, documented or suspected hypersensitivity to cytarabine (not including drug fever or exanthema, including known cerebellar side effects) or daunorubicin.\n      * For subjects assigned to non intensive chemotherapy, documented or suspected hypersensitivity to azacitidine or mannitol.\n     \n     \n 16. Known active drug or alcohol abuse.\n 17. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.\n 18. Pregnant females or breastfeeding female subjects.\n 19. Known recent or active suicidal ideation or behavior.\n 20. Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.","FSH",null,"Protein","Ovary","Actual","2018-01-31","Actual","Anticipated","2025-07-22","Anticipated","2018-11-01","2017-12-21","2018-01-23","2018-11-21","Yes","glasdegib;\nuntreated;\nHedgehog Inhibitor","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"All",null,"No","Yes\nInformation relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests",null,"URL: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1371019&StudyName=A+Randomized+%281%3A1%29%2C+Double+Blind%2C+Multi+Center%2C+Placebo+Controlled+Study+Evaluating+Intensive+Chemotherapy+With+Or+Without+Glasdegib+%28pf+04449913%29+Or+Azacitidine+%28aza%29+With+Or+Without+Glasdegib+In+Patients+With+Previously+Untreated+Acute+Myeloid+Leukemia [https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1371019&StudyName=A+Randomized+%281%3A1%29%2C+Double+Blind%2C+Multi+Center%2C+Placebo+Controlled+Study+Evaluating+Intensive+Chemotherapy+With+Or+Without+Glasdegib+%28pf+04449913%29+Or+Azacitidine+%28aza%29+With+Or+Without+Glasdegib+In+Patients+With+Previously+Untreated+Acute+Myeloid+Leukemia] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To obtain contact information for a study center near you, click here.",null,"Yes","No",{"$nulls":17},"2017-002822-19|BRIGHT|BRIGHT AML1019","EudraCT Number|Alias Study Number","Overall survival","5 years after last subject randomized",null,"Fatigue score measured by the MD Anderson Symptom Inventory (MDASI)-AML/MDS questionnaire|Rate of Complete Remission (CR) (including CR with minimal residual disease (MRD)-negative as assessed by multiparametric flow cytometry)|Duration of response (defined as CR [includes CR-MRD negative]/CRi or CR/CRh as appropriate)|Time to response (CR[includes CR-MRD negative)]/CR with partial hematologic rcovery (CRh) as appropriate)|Event-free Survival|Patient Reported Outcomes (PROs) as measured by the M.D. Anderson Symptom Inventory AML/MDS Module (MDASI-AML/MDS)|Adverse events as graded by NCI CTCAE v4.03|Laboratory abnormalities as graded by NCI CTCAE v4.03|For the intensive study, the plasma trough concentration (Ctrough) will be analyzed|QTc interval|PROs as measured by Patient Global Impression of Change (PGIC)|Patient Reported Outcomes (PROs) as measured by EuroQoL 5 Dimension questionnaire 5-Level version (EQ-5D-5L)|Patient Reported Outcomes (PROs) as measured by Patient Global Impression of Symptoms (PGIS)|Complete Remission with incomplete hematologic recovery (CRi)|Rate of morphological leukemia-free state (MLFS)|Rate of Partial Remission (PR)|Rate of Complete Remission with partial hematological recovery (CRh) for the Non-intensive study only only|Minimum Observed Plasma Trough Concentratrion of glasdegib in the Intensive Study|Minimum Observed Plasma Trough Concentration of glasdegib in the Non-intensive study","Scale is from 0-10 where 0 is not present and 10 is as bad as you can image.|Response as defined by the 2017 European LeukemiaNet (ELN) recommendations.|5 years after last subject randomized, consent withdrawal, or death|Measurement Scale from 0-10.|PK samples taken on Induction(s) Day 1 (1 and 4 hours post induction); Induction(s) Day 10 (pre-dose, 1 and 4 hours post dose); Day 1 of each Consolidation cycle (pre-dose, 1 and 4 hours post dose)|One question asking for description of leukemia symptoms.|Series of questions that ask for information that best describes health.|One question asking for information regarding leukemia symptoms.|Its the minimum trough concentration in plasma of glasdegib following multiple daily dosing to steady state.|It is the minimum trough concentration in plasma of glasdegib following multiple daily dosing to steady state.","5 years after last subject randomized, consent withdrawal, or death|2 years after last dose of study therapy|5 years after last patient randomized, withdrawal, or death|5 years after last subject randomized, withdrawal, or death|Day 10 of Induction Cycle and Day 1 of each Consolidation Cycle|Cycle 1 Day 15 and Cycles 2 and 3 on Day 1","ClinicalTrials.gov_Inquiries@pfizer.com","Pfizer CT.gov Call Center","1-800-718-1021","Darlinghurst, New South Wales, Australia, 2010|Brno, Czechia, 625 00 Nemocnicni LekarnaBrno, Czechia, 625 00 InternÃ­ HematologickÃ¡ Klinika, Fakultni Nemocnice KrÃ¡lovskÃ© VinohradyPraha 10, Czechia, 100 34 Ãšstavni LÃ©kÃ¡rnaPraha 10, Czechia, 100 34|Creteil, France, 94010 Chu Henri MondorCrÃ©teil, France, 94010 Chu De NantesNantes Cedex 1, France, 44093 Chu De Nantes Hotel DieuNantes Cedex, France, 44093 Hopital Saint LouisParis, France, 75010 Centre Hospitalier Lyon Sud -Unite De Pharmacie Clinique OncologiquePierre Benite Cedex, France, 69495 Centre Hospitalier Lyon Sud - Service D'HematologiePierre Benite Cedex, France, 69495|Haifa, Israel, 3109601 Shaare Zedek Medical CanterJerusalem, Israel, 9103102 Shaare Zedek Medical CenterJerusalem, Israel, 9103102 Hadassah Medical CenterJerusalem, Israel, 91120 Belinson Mc, Davidof Cancer Center- Hematology DepartmentPetach Tikva, Israel, 49100 Tel-Aviv Sourasky Medical CenterTel Aviv, Israel, 6423906|Nagoya, Aichi, Japan, 466-8650|Akita, Japan, 010-8543 Kyushu University HospitalFukuoka, Japan, 812-8582 National Hospital Organization Kumamoto Medical CenterKumamoto, Japan, 860-0008 Nagasaki University HospitalNagasaki, Japan, 852-8501 Tokyo Medical University HospitalTokyo, Japan, 160-0023 Korea, Republic Of, Jeollabuk-Do Chonbuk National University HospitalJeonju-Si, Jeollabuk-Do, Korea, Republic Of, 54907 Korea, Republic Of, Jeollanam-Do Chonnam National University Hwasun HospitalHwasun-Gun, Jeollanam-Do, Korea, Republic Of, 58128 Korea, Republic Of Department Of Pharmacy, Inje University Busan Paik HospitalBusan, Korea, Republic Of, 47392 Inje University Busan Paik HospitalBusan, Korea, Republic Of, 47392 Clinical Trial Pharmacy, Keimyung University Dongsan HospitalDaegu, Korea, Republic Of, 41931 Keimyung University Dongsan HospitalDaegu, Korea, Republic Of, 41931 Gachon University Gil Medical CenterIncheon, Korea, Republic Of, 21565 Seoul National University HospitalSeoul, Korea, Republic Of, 03080 Clinical Trial Center, Severance Hospital, Yonsei University Health System (Drug Shipment Only)Seoul, Korea, Republic Of, 03722 Severance Hospital, Yonsei University Health SystemSeoul, Korea, Republic Of, 03722 Department Of Pharmacy, Samsung Medical CenterSeoul, Korea, Republic Of, 06351 Samsung Medical CenterSeoul, Korea, Republic Of, 06351 The Catholic University Of Korea Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591 The Catholic University Of Korea, Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591|Yoshida-Gun, Fukui, Japan, 910-1193|Maebashi, Gunma, Japan, 371-8511|Kobe-Shi, Hyogo, Japan, 650-0017|Yokohama, Kanagawa, Japan, 232-0024|Sendai, Miyagi, Japan, 980-8574|Osaka-City, Osaka, Japan, 545-8586 Kindai University HospitalOsaka-Sayama, Osaka, Japan, 589-8511|Sunto-Gun, Shizuoka, Japan, 411-8777|Tachikawa, Tokyo, Japan, 190-0014|Gdansk, Poland, 80-952|Craiova, Dolj, Romania, 200143|Bucuresti, Romania, 030171 Russian Federation Sbhi Cch No. 40 Hd MoscowMoscow, Russian Federation, 129301 State Budgetary Healthcare Institution Of MoscowMoscow, Russian Federation, 129301 Sbhi Nnr Nn Rch N. A. N.A. SemashkoNizhniy Novgorod, Russian Federation, 603126 State Budgetary Institution Of Ryazan Region 'Regional Clinical Hospital' (Sbi Rr Rch)Ryazan, Russian Federation, 390039 Drug Shipment Address:Saint Petersburg, Russian Federation, 191024 Fsbi Russrhti Fmba Of|Barcelona, Spain, 08003 Hospital De La Santa Creu I Sant PauBarcelona, Spain, 08025 Hospital Universitario Arnau De VilanovaLleida, Spain, 25198 Hospital General Universitario Gregorio MaranonMadrid, Spain, 28007 Hospital Universitario Ramon Y CajalMadrid, Spain, 28034 Hospital Universitario Virgen Del RocioSevilla, Spain, 41013 Hospital Universitari I Politecnic La FeValencia, Spain, 46026 Taiwan Department Of Clinical Trial Pharmacy, Taipei Veterans General HospitalTaipei, Taiwan, 11217 Taipei Veterans General HospitalTaipei, Taiwan, 11217 Division Of Pharmacy, Koo Foundation Sun Yat-Sen Cancer CenterTaipei, Taiwan, 112 Koo Foundation Sun Yat-Sen Cancer CenterTaipei, Taiwan, 112 Chang Gung Memorial Hospital-Linkou BranchTaoyuan City, Taiwan, 333 Chemotherapy Pharmacy, Chang Gung Memorial Hospital-Linkou BranchTaoyuan City, Taiwan, 333|Sutton, Surrey, United Kingdom, Sm2 5Pt|Los Angeles, California, United States, 90095 Ucla Department Of MedicineLos Angeles, California, United States, 90095 Ucla Hematology/Oncology ClinicLos Angeles, California, United States, 90095 Ucla Ronald Reagan Medical CenterLos Angeles, California, United States, 90095 Uc Irvine Health - Chao Family Comprehensive Cancer CenterOrange, California, United States, 92868-3201 Uc Irvine Medical CenterOrange, California, United States, 92868-3201 Ucsf Helen Diller Family Comprehensive Cancer CenterSan Francisco, California, United States, 94143 University Of California, San Francisco Medical CenterSan Francisco, California, United States, 94143 University Of California, San FranciscoSan Francisco, California, United States, 94143|Kansas City, Missouri, United States, 64132|Lake Success, New York, United States, 11042 North Shore University HospitalManhasset, New York, United States, 11030 Long Island Jewish Medical CenterNew Hyde Park, New York, United States, 11040 University Of Rochester Cancer Center PharmacyRochester, New York, United States, 14642 University Of Rochester Medical CenterRochester, New York, United States, 14642|Cleveland, Ohio, United States, 44106 University Hospitals Cleveland Medical CenterCleveland, Ohio, United States, 44106 Cleveland Clinic FoundationCleveland, Ohio, United States, 44195|Nashville, Tennessee, United States, 37203|Dallas, Texas, United States, 75246 Baylor University Medical CenterDallas, Texas, United States, 75246 Blood Cancer And Stem Cell Transplant ClinicSan Antonio, Texas, United States, 78229 Methodist Healthcare System Of San AntonioSan Antonio, Texas, United States, 78229 Methodist Hospital Investigational PharmacySan Antonio, Texas, United States, 78229|Seattle, Washington, United States, 98104 Swedish Investigational Drug Services PharmacySeattle, Washington, United States, 98104 Swedish Medical CenterSeattle, Washington, United States, 98122","California|Missouri|New York|Ohio|Tennessee|Texas|Washington","Australia|Czechia|France|Israel|Japan|Poland|Romania|Spain|United Kingdom|United States","New South Wales St Vincent's Hospital Sydney|Interni Hematologicka A Onkologicka Klinika, Fakultni Nemocnice Brno|Chu Henri Mondor|Rambam Health Care Campus|Aichi Japanese Red Cross Nagoya Daini Hospital|Akita University Hospital|Fukui University Of Fukui Hospital|Gunma Gunma University Hospital|Hyogo Kobe University Hospital|Kanagawa Yokohama City University Medical Center|Miyagi Tohoku University Hospital|Osaka Osaka City University Hospital|Shizuoka Shizuoka Cancer Center|Tokyo National Hospital Organization Disaster Medical Center|Klinika Hematologii I Transplantologii Uniwersyteckie Centrum Kliniczne|Dolj Spitalul Clinic Municipal Filantropia Craiova, Sectia Clinica Hematologie|Spitalul Clinic Coltea, Clinica De Hematologie|Hospital Del Mar|, Surrey The Royal Marsden Nhs Foundation Trust|Rrmc - Ucla|Midamerica Division, Inc., C/O Research Medical Center|Northwell Health Monter Cancer Center|Taussig Cancer Center Investigational Pharmacy|The Sarah Cannon Research Institute|Baylor Scott And White Research Institute|Swedish Cancer Institute",{"$nulls":3},"Pfizer CT.gov Call Center","2018-11-21","2020-05-25T16:39:30.524","2020-05-26T17:10:42.972","NCT03416179"]
["5ecbf4c211702c1b1b916bc3","NCT03416179","2018-12-04","Pfizer","PFE","Recruiting","A Study Evaluating Intensive Chemotherapy With or Without Glasdegib or Azacitidine With or Without Glasdegib In Patients With Previously Untreated Acute Myeloid Leukemia (BRIGHT AML1019)","Glasdegib|Cytarabine|Daunorubicin|Azacitidine","Hh Inhibitor|DNA Polymerase Inhibitor|Nucleic Acid Synthesis Inhibitor|TOP2 Inhibitor|DNA Mtase Inhibitor","Unknown",null,"Unknown",null,"Phase 3",4,720,"Anticipated","2018-04-20","2021-06-13","OS","Overall Survival",{"$nulls":3},"Glasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).\n\nGlasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).","Two separate registration trials conducted under one protocol number are proposed to adequately and independently evaluate the addition of glasdegib in intensive and non-intensive chemotherapy populations. Each study will have an experimental treatment arm and a placebo arm. Endpoints are the same for each study except where specifically indicated.\n\nAssignment to the Intensive Study or the Non-Intensive Study will be made by the Investigator based on the 2017 European LeukemiaNet (ELN) recommendations.\n\nStudy B1371019 is a randomized (1:1), double-blind, multi-center, placebo controlled study of chemotherapy in combination with glasdegib versus chemotherapy in combination with placebo in adult patients with previously untreated AML.\n\nGlasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).\n\nGlasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).","A RANDOMIZED (1:1), DOUBLE-BLIND, MULTI-CENTER, PLACEBO CONTROLLED STUDY EVALUATING INTENSIVE CHEMOTHERAPY WITH OR WITHOUT GLASDEGIB (PF-04449913) OR AZACITIDINE (AZA) WITH OR WITHOUT GLASDEGIB IN PATIENTS WITH PREVIOUSLY UNTREATED ACUTE MYELOID LEUKEMIA","B1371019","Leukemia, Myeloid, Acute","Acute Leukemia|Acute Myeloid Leukemia|Myeloid Leukemia|Leukemia","Oncology Hematological","Oncology","Experimental|Placebo Comparator","Arm A (Intensive Study)|Arm B (Intensive Study)|Arm A (Non-intensive study)|Arm B (Non-intensive study)","Glasdegib + '7+3' Induction(s)|Placebo + '7+3' Induction(s)|Glasdegib + azacitidine|Placebo + azacitidine","Drug|Procedure","glasdegib|daunorubicin + cytarabine|cytarabine|HSCT|Placebo|azacitidine","Daily Glasdegib (100 mg, PO), beginning on Day 1 and is to continue up to 2 years post randomization.\n\nFollowing consolidation therapy, glasdegib or placebo will be administered daily for up to 2 years after randomization or until they have minimal residual disease (MRD) negative disease, whichever comes first.\n\nDaily Glasdegib (100 mg, PO) or matching placebo will continue throughout Induction(s) and Consolidation therapies regardless of dose modifications/delays in the chemotherapy.|Consolidation with single agent cytarabine 3 g/m2 IV for adults <60 years and 1 g/m2 for adults 60 years over 3 BID on Days 1, 3, and 5, every 28 days for up to 4 cycles or alternative single agent cytarabine consolidation schedules may be used per local prescribing information.|If required, and done per standard of care post Induction(s).|Azacitidine (75 mg/m2, SC or IV) daily for 7 days, in 28 day cycles for as long as they do not meet the criteria for disease progression, unacceptable toxicity, consent withdrawal, or death.|Matching placebo (PO) is to be administered by mouth daily beginning on Day 1 of chemotherapy and will continue if subjects demonstrate reasonable evidence of clinical benefit and do not meet the criteria for progression regardless of any delays/modifications in the chemotherapy treatment. Subjects will continue placebo until disease progression, unacceptable toxicity, consent withdrawal, or death, whichever comes first.","PF-04449913","Arm A (Intensive Study)|Arm B (Intensive Study)|Arm A (Non-intensive study)|Arm B (Non-intensive study)","\n\nSubjects must meet all of the following inclusion criteria to be eligible for enrollment into the Intensive and Non Intensive study (unless where indicated):\n\n 1.  Subjects with untreated AML according to the World Health Organization (WHO) 2016 Classification2, including those with: * AML arising from MDS or another antecedent hematologic disease (AHD).\n      * AML after previous cytotoxic therapy or radiation (secondary AML).\n     \n     \n 2.  18 years of age (In Japan, 20 years of age).\n 3.  Adequate Organ Function as defined by the following: * Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) 3 x upper limit of normal (ULN), excluding subjects with liver function abnormalities due to underlying malignancy.\n      * Total serum bilirubin 2 x ULN (except subjects with documented Gilbert's syndrome).\n      * Estimated creatinine clearance 30 mL/min as calculated using the standard method for the institution.\n     \n     \n 4.  QTc interval 470 msec using the Fridericia correction (QTcF).\n 5.  All anti cancer treatments (unless specified) should be discontinued 2 weeks from study entry, for example: targeted chemotherapy, radiotherapy, investigational agents, hormones, anagrelide or cytokines. * For control of rapidly progressing leukemia, all trans retinoic acid (ATRA), hydroxyurea, and/or leukopheresis may be used before and for up to 1 week after the first dose of glasdegib.\n     \n     \n 6.  Serum or urine pregnancy test (for female subjects of childbearing potential) with a minimum sensitivity of 25 IU/L or equivalent units of human chorionic gonadotropin (hCG) negative at screening.\n 7.  Male and female subjects of childbearing potential and at risk for pregnancy must agree to use at least one highly effective method of contraception throughout the study and for 180 days after the last dose of azacitidine, cytarabine, or daunorubicin; and the last dose of glasdegib or placebo, whichever occurs later.\n 8.  Female subjects of non childbearing potential must meet at least 1 of the following criteria: 1. Have undergone a documented hysterectomy and/or bilateral oophorectomy;\n      2. Have medically confirmed ovarian failure; or\n      3. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; status may be confirmed by having a serum follicle stimulating hormone (FSH) level confirming the postmenopausal state.\n     \n     All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential.\n     \n     \n 9.  Consent to a saliva sample collection for a germline comparator, unless prohibited by local regulations or ethics committee (EC) decision.\n 10. Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.\n 11. Subjects who are willing and able to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures (including bone marrow [BM] assessments).\n\n","\n\nSubjects with any of the following characteristics/conditions will not be included in the study:\n\n 1.  Acute Promyelocytic Leukemia (APL) and APLwith PML RARA, subjects (WHO 2016 classification).\n 2.  AML with BCR ABL1 or t(9;22)(q34;q11.2) as a sole abnormality. * Complex genetics may include t(9;22) cytogenetic translocation.\n     \n     \n 3.  Subjects with known active CNS leukemia.\n 4.  Participation in other clinical studies involving other investigational drug(s) (Phases 1 4) within 4 weeks prior study entry and/or during study participation.\n 5.  Subjects known to be refractory to platelet or packed red cell transfusions per Institutional Guidelines, or a patient who refuses blood product support.\n 6.  Subjects with another active malignancy on treatment with the exception of basal cell carcinoma, non melanoma skin cancer, cervical carcinoma in situ. Other prior or concurrent malignancies will be considered on a case by case basis.\n 7.  Any one of the following ongoing or in the previous 6 months: myocardial infarction, congenital long QT syndrome, Torsades de pointes, symptomatic arrhythmias (including sustained ventricular tachyarrhythmia), right or left bundle branch block and bifascicular block, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (CHF New York Heart Association class III or IV), cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism; as well as bradycardia defined as <50 bpms.\n 8.  Subjects with an active, life threatening or clinically significant uncontrolled systemic infection not related to AML.\n 9.  Subjects with left ventricular ejection fraction (LVEF) <50% are excluded from the Intensive Chemotherapy Study only.\n 10. Cumulative anthracycline dose equivalent of 550 mg/m2 of daunorubicin for the Intensive Chemotherapy Study only.\n 11. Known malabsorption syndrome or other condition that may significantly impair absorption of study medication in the investigator's judgment (eg, gastrectomy, lap band, Crohn's disease) and inability or unwillingness to swallow tablets or capsules.\n 12. Current use or anticipated requirement for drugs that are known strong CYP3A4/5 inducers.\n 13. Concurrent administration of herbal preparations.\n 14. Major surgery or radiation within 4 weeks of starting study treatment.\n 15. Documented or suspected hypersensitivity to any one of the following: * For subjects assigned to intensive chemotherapy, documented or suspected hypersensitivity to cytarabine (not including drug fever or exanthema, including known cerebellar side effects) or daunorubicin.\n      * For subjects assigned to non intensive chemotherapy, documented or suspected hypersensitivity to azacitidine or mannitol.\n     \n     \n 16. Known active drug or alcohol abuse.\n 17. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.\n 18. Pregnant females or breastfeeding female subjects.\n 19. Known recent or active suicidal ideation or behavior.\n 20. Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.","FSH",null,"Protein","Ovary","Actual","2018-01-31","Actual","Anticipated","2025-07-22","Anticipated","2018-12-01","2017-12-21","2018-01-23","2018-12-01","Yes","glasdegib;\nuntreated;\nHedgehog Inhibitor","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"All",null,"No","Yes\nInformation relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests",null,"URL: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1371019&StudyName=A+Randomized+%281%3A1%29%2C+Double+Blind%2C+Multi+Center%2C+Placebo+Controlled+Study+Evaluating+Intensive+Chemotherapy+With+Or+Without+Glasdegib+%28pf+04449913%29+Or+Azacitidine+%28aza%29+With+Or+Without+Glasdegib+In+Patients+With+Previously+Untreated+Acute+Myeloid+Leukemia [https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1371019&StudyName=A+Randomized+%281%3A1%29%2C+Double+Blind%2C+Multi+Center%2C+Placebo+Controlled+Study+Evaluating+Intensive+Chemotherapy+With+Or+Without+Glasdegib+%28pf+04449913%29+Or+Azacitidine+%28aza%29+With+Or+Without+Glasdegib+In+Patients+With+Previously+Untreated+Acute+Myeloid+Leukemia] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To obtain contact information for a study center near you, click here.",null,"Yes","No",{"$nulls":17},"2017-002822-19|BRIGHT|BRIGHT AML1019","EudraCT Number|Alias Study Number","Overall survival","5 years after last subject randomized",null,"Fatigue score measured by the MD Anderson Symptom Inventory (MDASI)-AML/MDS questionnaire|Rate of Complete Remission (CR) (including CR with minimal residual disease (MRD)-negative as assessed by multiparametric flow cytometry)|Duration of response (defined as CR [includes CR-MRD negative]/CRi or CR/CRh as appropriate)|Time to response (CR[includes CR-MRD negative)]/CR with partial hematologic rcovery (CRh) as appropriate)|Event-free Survival|Patient Reported Outcomes (PROs) as measured by the M.D. Anderson Symptom Inventory AML/MDS Module (MDASI-AML/MDS)|Adverse events as graded by NCI CTCAE v4.03|Laboratory abnormalities as graded by NCI CTCAE v4.03|For the intensive study, the plasma trough concentration (Ctrough) will be analyzed|QTc interval|PROs as measured by Patient Global Impression of Change (PGIC)|Patient Reported Outcomes (PROs) as measured by EuroQoL 5 Dimension questionnaire 5-Level version (EQ-5D-5L)|Patient Reported Outcomes (PROs) as measured by Patient Global Impression of Symptoms (PGIS)|Complete Remission with incomplete hematologic recovery (CRi)|Rate of morphological leukemia-free state (MLFS)|Rate of Partial Remission (PR)|Rate of Complete Remission with partial hematological recovery (CRh) for the Non-intensive study only only|Minimum Observed Plasma Trough Concentratrion of glasdegib in the Intensive Study|Minimum Observed Plasma Trough Concentration of glasdegib in the Non-intensive study","Scale is from 0-10 where 0 is not present and 10 is as bad as you can image.|Response as defined by the 2017 European LeukemiaNet (ELN) recommendations.|5 years after last subject randomized, consent withdrawal, or death|Measurement Scale from 0-10.|PK samples taken on Induction(s) Day 1 (1 and 4 hours post induction); Induction(s) Day 10 (pre-dose, 1 and 4 hours post dose); Day 1 of each Consolidation cycle (pre-dose, 1 and 4 hours post dose)|One question asking for description of leukemia symptoms.|Series of questions that ask for information that best describes health.|One question asking for information regarding leukemia symptoms.|Its the minimum trough concentration in plasma of glasdegib following multiple daily dosing to steady state.|It is the minimum trough concentration in plasma of glasdegib following multiple daily dosing to steady state.","5 years after last subject randomized, consent withdrawal, or death|2 years after last dose of study therapy|5 years after last patient randomized, withdrawal, or death|5 years after last subject randomized, withdrawal, or death|Day 10 of Induction Cycle and Day 1 of each Consolidation Cycle|Cycle 1 Day 15 and Cycles 2 and 3 on Day 1","ClinicalTrials.gov_Inquiries@pfizer.com","Pfizer CT.gov Call Center","1-800-718-1021","Adelaide, South|Darlinghurst, New South Wales, Australia, 2010 St George HospitalKogarah, New South Wales, Australia, 2217|Brno, Czechia, 625 00 Nemocnicni LekarnaBrno, Czechia, 625 00 InternÃ­ HematologickÃ¡ Klinika, Fakultni Nemocnice KrÃ¡lovskÃ© VinohradyPraha 10, Czechia, 100 34 Ãšstavni LÃ©kÃ¡rnaPraha 10, Czechia, 100 34|Creteil, France, 94010 Chu Henri MondorCrÃ©teil, France, 94010 Chu De NantesNantes Cedex 1, France, 44093 Chu De Nantes Hotel DieuNantes Cedex, France, 44093 Hopital Saint LouisParis, France, 75010 Centre Hospitalier Lyon Sud -Unite De Pharmacie Clinique OncologiquePierre Benite Cedex, France, 69495 Centre Hospitalier Lyon Sud - Service D'HematologiePierre Benite Cedex, France, 69495|Cona, Ferrara, Fe, Italy, 44124 Farmacia OspedalieraFerrara, Fe, Italy, 44121|Nagoya, Aichi, Japan, 466-8650|Akita, Japan, 010-8543 Kyushu University HospitalFukuoka, Japan, 812-8582 National Hospital Organization Kumamoto Medical CenterKumamoto, Japan, 860-0008 Nagasaki University HospitalNagasaki, Japan, 852-8501 Tokyo Medical University HospitalTokyo, Japan, 160-0023 Korea, Republic Of, Jeollabuk-Do Chonbuk National University HospitalJeonju-Si, Jeollabuk-Do, Korea, Republic Of, 54907 Korea, Republic Of, Jeollanam-Do Chonnam National University Hwasun HospitalHwasun-Gun, Jeollanam-Do, Korea, Republic Of, 58128 Korea, Republic Of Department Of Pharmacy, Inje University Busan Paik HospitalBusan, Korea, Republic Of, 47392 Inje University Busan Paik HospitalBusan, Korea, Republic Of, 47392 Clinical Trial Pharmacy, Keimyung University Dongsan HospitalDaegu, Korea, Republic Of, 41931 Keimyung University Dongsan HospitalDaegu, Korea, Republic Of, 41931 Gachon University Gil Medical CenterIncheon, Korea, Republic Of, 21565 Seoul National University HospitalSeoul, Korea, Republic Of, 03080 Clinical Trial Center, Severance Hospital, Yonsei University Health System (Drug Shipment Only)Seoul, Korea, Republic Of, 03722 Severance Hospital, Yonsei University Health SystemSeoul, Korea, Republic Of, 03722 Department Of Pharmacy, Samsung Medical CenterSeoul, Korea, Republic Of, 06351 Samsung Medical CenterSeoul, Korea, Republic Of, 06351 The Catholic University Of Korea Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591 The Catholic University Of Korea, Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591|Yoshida-Gun, Fukui, Japan, 910-1193|Maebashi, Gunma, Japan, 371-8511|Kobe-Shi, Hyogo, Japan, 650-0017|Yokohama, Kanagawa, Japan, 232-0024|Sendai, Miyagi, Japan, 980-8574|Osaka-City, Osaka, Japan, 545-8586 Kindai University HospitalOsaka-Sayama, Osaka, Japan, 589-8511|Sunto-Gun, Shizuoka, Japan, 411-8777|Tachikawa, Tokyo, Japan, 190-0014|Gdansk, Poland, 80-952|Craiova, Dolj, Romania, 200143|Bucuresti, Romania, 030171 Russian Federation Sbhi Cch No. 40 Hd MoscowMoscow, Russian Federation, 129301 State Budgetary Healthcare Institution Of MoscowMoscow, Russian Federation, 129301 Sbhi Nnr Nn Rch N. A. N.A. SemashkoNizhniy Novgorod, Russian Federation, 603126 State Budgetary Institution Of Ryazan Region 'Regional Clinical Hospital' (Sbi Rr Rch)Ryazan, Russian Federation, 390039 Drug Shipment Address:Saint Petersburg, Russian Federation, 191024 Fsbi Russrhti Fmba Of|Barcelona, Spain, 08003 Hospital De La Santa Creu I Sant PauBarcelona, Spain, 08025 Hospital Universitario Arnau De VilanovaLleida, Spain, 25198 Hospital General Universitario Gregorio MaranonMadrid, Spain, 28007 Hospital Universitario Ramon Y CajalMadrid, Spain, 28034 Hospital Universitario Virgen Del RocioSevilla, Spain, 41013 Hospital Universitari I Politecnic La FeValencia, Spain, 46026 Taiwan Department Of Clinical Trial Pharmacy, Taipei Veterans General HospitalTaipei, Taiwan, 11217 Taipei Veterans General HospitalTaipei, Taiwan, 11217 Division Of Pharmacy, Koo Foundation Sun Yat-Sen Cancer CenterTaipei, Taiwan, 112 Koo Foundation Sun Yat-Sen Cancer CenterTaipei, Taiwan, 112 Chang Gung Memorial Hospital-Linkou BranchTaoyuan City, Taiwan, 333 Chemotherapy Pharmacy, Chang Gung Memorial Hospital-Linkou BranchTaoyuan City, Taiwan, 333|Sutton, Surrey, United Kingdom, Sm2 5Pt|Los Angeles, California, United States, 90095 Ucla Department Of MedicineLos Angeles, California, United States, 90095 Ucla Hematology/Oncology ClinicLos Angeles, California, United States, 90095 Ucla Ronald Reagan Medical CenterLos Angeles, California, United States, 90095 Uc Irvine Health - Chao Family Comprehensive Cancer CenterOrange, California, United States, 92868-3201 Uc Irvine Medical CenterOrange, California, United States, 92868-3201 Ucsf Helen Diller Family Comprehensive Cancer CenterSan Francisco, California, United States, 94143 University Of California, San Francisco Medical CenterSan Francisco, California, United States, 94143 University Of California, San FranciscoSan Francisco, California, United States, 94143|Kansas City, Missouri, United States, 64132|Lake Success, New York, United States, 11042 North Shore University HospitalManhasset, New York, United States, 11030 Long Island Jewish Medical CenterNew Hyde Park, New York, United States, 11040 University Of Rochester Cancer Center PharmacyRochester, New York, United States, 14642 University Of Rochester Medical CenterRochester, New York, United States, 14642|Cleveland, Ohio, United States, 44106 University Hospitals Cleveland Medical CenterCleveland, Ohio, United States, 44106 Cleveland Clinic FoundationCleveland, Ohio, United States, 44195|Nashville, Tennessee, United States, 37203|Dallas, Texas, United States, 75246 Baylor University Medical CenterDallas, Texas, United States, 75246 Blood Cancer And Stem Cell Transplant ClinicSan Antonio, Texas, United States, 78229 Methodist Healthcare System Of San AntonioSan Antonio, Texas, United States, 78229 Methodist Hospital Investigational PharmacySan Antonio, Texas, United States, 78229|Seattle, Washington, United States, 98104 Swedish Investigational Drug Services PharmacySeattle, Washington, United States, 98104 Swedish Medical CenterSeattle, Washington, United States, 98122","California|Missouri|New York|Ohio|Tennessee|Texas|Washington","Australia|Czechia|France|Italy|Japan|Poland|Romania|Spain|United Kingdom|United States","Australia, 5000 Royal Adelaide Hospital - Clinical Trials Pharmacy|Haematology And Bone Marrow Transplant Unit, Royal Adelaide Hospital|New South Wales St Vincent's Hospital Sydney|Interni Hematologicka A Onkologicka Klinika, Fakultni Nemocnice Brno|Chu Henri Mondor|Fe A.O.U. Di Ferrara- Arcispedale Sant'Anna,|Aichi Japanese Red Cross Nagoya Daini Hospital|Akita University Hospital|Fukui University Of Fukui Hospital|Gunma Gunma University Hospital|Hyogo Kobe University Hospital|Kanagawa Yokohama City University Medical Center|Miyagi Tohoku University Hospital|Osaka Osaka City University Hospital|Shizuoka Shizuoka Cancer Center|Tokyo National Hospital Organization Disaster Medical Center|Klinika Hematologii I Transplantologii Uniwersyteckie Centrum Kliniczne|Dolj Spitalul Clinic Municipal Filantropia Craiova, Sectia Clinica Hematologie|Spitalul Clinic Coltea, Clinica De Hematologie|Hospital Del Mar|, Surrey The Royal Marsden Nhs Foundation Trust|Rrmc - Ucla|Midamerica Division, Inc., C/O Research Medical Center|Northwell Health Monter Cancer Center|Taussig Cancer Center Investigational Pharmacy|The Sarah Cannon Research Institute|Baylor Scott And White Research Institute|Swedish Cancer Institute",{"$nulls":3},"Pfizer CT.gov Call Center","2018-12-01","2020-05-25T16:39:30.971","2020-05-26T17:10:42.972","NCT03416179"]
["5ecbf4c3fe30261b1a0483b7","NCT03416179","2018-12-19","Pfizer","PFE","Recruiting","A Study Evaluating Intensive Chemotherapy With or Without Glasdegib or Azacitidine With or Without Glasdegib In Patients With Previously Untreated Acute Myeloid Leukemia (BRIGHT AML1019)","Glasdegib|Cytarabine|Daunorubicin|Azacitidine","Hh Inhibitor|DNA Polymerase Inhibitor|Nucleic Acid Synthesis Inhibitor|TOP2 Inhibitor|DNA Mtase Inhibitor","Unknown",null,"Unknown",null,"Phase 3",4,720,"Anticipated","2018-04-20","2021-06-13","OS","Overall Survival",{"$nulls":3},"Glasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).\n\nGlasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).","Two separate registration trials conducted under one protocol number are proposed to adequately and independently evaluate the addition of glasdegib in intensive and non-intensive chemotherapy populations. Each study will have an experimental treatment arm and a placebo arm. Endpoints are the same for each study except where specifically indicated.\n\nAssignment to the Intensive Study or the Non-Intensive Study will be made by the Investigator based on the 2017 European LeukemiaNet (ELN) recommendations.\n\nStudy B1371019 is a randomized (1:1), double-blind, multi-center, placebo controlled study of chemotherapy in combination with glasdegib versus chemotherapy in combination with placebo in adult patients with previously untreated AML.\n\nGlasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).\n\nGlasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).","A RANDOMIZED (1:1), DOUBLE-BLIND, MULTI-CENTER, PLACEBO CONTROLLED STUDY EVALUATING INTENSIVE CHEMOTHERAPY WITH OR WITHOUT GLASDEGIB (PF-04449913) OR AZACITIDINE (AZA) WITH OR WITHOUT GLASDEGIB IN PATIENTS WITH PREVIOUSLY UNTREATED ACUTE MYELOID LEUKEMIA","B1371019","Leukemia, Myeloid, Acute","Acute Leukemia|Acute Myeloid Leukemia|Myeloid Leukemia|Leukemia","Oncology Hematological","Oncology","Experimental|Placebo Comparator","Arm A (Intensive Study)|Arm B (Intensive Study)|Arm A (Non-intensive study)|Arm B (Non-intensive study)","Glasdegib + '7+3' Induction(s)|Placebo + '7+3' Induction(s)|Glasdegib + azacitidine|Placebo + azacitidine","Drug|Procedure","glasdegib|daunorubicin + cytarabine|cytarabine|HSCT|Placebo|azacitidine","Daily Glasdegib (100 mg, PO), beginning on Day 1 and is to continue up to 2 years post randomization.\n\nFollowing consolidation therapy, glasdegib or placebo will be administered daily for up to 2 years after randomization or until they have minimal residual disease (MRD) negative disease, whichever comes first.\n\nDaily Glasdegib (100 mg, PO) or matching placebo will continue throughout Induction(s) and Consolidation therapies regardless of dose modifications/delays in the chemotherapy.|Consolidation with single agent cytarabine 3 g/m2 IV for adults <60 years and 1 g/m2 for adults 60 years over 3 BID on Days 1, 3, and 5, every 28 days for up to 4 cycles or alternative single agent cytarabine consolidation schedules may be used per local prescribing information.|If required, and done per standard of care post Induction(s).|Azacitidine (75 mg/m2, SC or IV) daily for 7 days, in 28 day cycles for as long as they do not meet the criteria for disease progression, unacceptable toxicity, consent withdrawal, or death.|Matching placebo (PO) is to be administered by mouth daily beginning on Day 1 of chemotherapy and will continue if subjects demonstrate reasonable evidence of clinical benefit and do not meet the criteria for progression regardless of any delays/modifications in the chemotherapy treatment. Subjects will continue placebo until disease progression, unacceptable toxicity, consent withdrawal, or death, whichever comes first.","PF-04449913","Arm A (Intensive Study)|Arm B (Intensive Study)|Arm A (Non-intensive study)|Arm B (Non-intensive study)","\n\nSubjects must meet all of the following inclusion criteria to be eligible for enrollment into the Intensive and Non Intensive study (unless where indicated):\n\n 1.  Subjects with untreated AML according to the World Health Organization (WHO) 2016 Classification2, including those with: * AML arising from MDS or another antecedent hematologic disease (AHD).\n      * AML after previous cytotoxic therapy or radiation (secondary AML).\n     \n     \n 2.  18 years of age (In Japan, 20 years of age).\n 3.  Adequate Organ Function as defined by the following: * Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) 3 x upper limit of normal (ULN), excluding subjects with liver function abnormalities due to underlying malignancy.\n      * Total serum bilirubin 2 x ULN (except subjects with documented Gilbert's syndrome).\n      * Estimated creatinine clearance 30 mL/min as calculated using the standard method for the institution.\n     \n     \n 4.  QTc interval 470 msec using the Fridericia correction (QTcF).\n 5.  All anti cancer treatments (unless specified) should be discontinued 2 weeks from study entry, for example: targeted chemotherapy, radiotherapy, investigational agents, hormones, anagrelide or cytokines. * For control of rapidly progressing leukemia, all trans retinoic acid (ATRA), hydroxyurea, and/or leukopheresis may be used before and for up to 1 week after the first dose of glasdegib.\n     \n     \n 6.  Serum or urine pregnancy test (for female subjects of childbearing potential) with a minimum sensitivity of 25 IU/L or equivalent units of human chorionic gonadotropin (hCG) negative at screening.\n 7.  Male and female subjects of childbearing potential and at risk for pregnancy must agree to use at least one highly effective method of contraception throughout the study and for 180 days after the last dose of azacitidine, cytarabine, or daunorubicin; and the last dose of glasdegib or placebo, whichever occurs later.\n 8.  Female subjects of non childbearing potential must meet at least 1 of the following criteria: 1. Have undergone a documented hysterectomy and/or bilateral oophorectomy;\n      2. Have medically confirmed ovarian failure; or\n      3. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; status may be confirmed by having a serum follicle stimulating hormone (FSH) level confirming the postmenopausal state.\n     \n     All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential.\n     \n     \n 9.  Consent to a saliva sample collection for a germline comparator, unless prohibited by local regulations or ethics committee (EC) decision.\n 10. Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.\n 11. Subjects who are willing and able to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures (including bone marrow [BM] assessments).\n\n","\n\nSubjects with any of the following characteristics/conditions will not be included in the study:\n\n 1.  Acute Promyelocytic Leukemia (APL) and APLwith PML RARA, subjects (WHO 2016 classification).\n 2.  AML with BCR ABL1 or t(9;22)(q34;q11.2) as a sole abnormality. * Complex genetics may include t(9;22) cytogenetic translocation.\n     \n     \n 3.  Subjects with known active CNS leukemia.\n 4.  Participation in other clinical studies involving other investigational drug(s) (Phases 1 4) within 4 weeks prior study entry and/or during study participation.\n 5.  Subjects known to be refractory to platelet or packed red cell transfusions per Institutional Guidelines, or a patient who refuses blood product support.\n 6.  Subjects with another active malignancy on treatment with the exception of basal cell carcinoma, non melanoma skin cancer, cervical carcinoma in situ. Other prior or concurrent malignancies will be considered on a case by case basis.\n 7.  Any one of the following ongoing or in the previous 6 months: myocardial infarction, congenital long QT syndrome, Torsades de pointes, symptomatic arrhythmias (including sustained ventricular tachyarrhythmia), right or left bundle branch block and bifascicular block, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (CHF New York Heart Association class III or IV), cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism; as well as bradycardia defined as <50 bpms.\n 8.  Subjects with an active, life threatening or clinically significant uncontrolled systemic infection not related to AML.\n 9.  Subjects with left ventricular ejection fraction (LVEF) <50% are excluded from the Intensive Chemotherapy Study only.\n 10. Cumulative anthracycline dose equivalent of 550 mg/m2 of daunorubicin for the Intensive Chemotherapy Study only.\n 11. Known malabsorption syndrome or other condition that may significantly impair absorption of study medication in the investigator's judgment (eg, gastrectomy, lap band, Crohn's disease) and inability or unwillingness to swallow tablets or capsules.\n 12. Current use or anticipated requirement for drugs that are known strong CYP3A4/5 inducers.\n 13. Concurrent administration of herbal preparations.\n 14. Major surgery or radiation within 4 weeks of starting study treatment.\n 15. Documented or suspected hypersensitivity to any one of the following: * For subjects assigned to intensive chemotherapy, documented or suspected hypersensitivity to cytarabine (not including drug fever or exanthema, including known cerebellar side effects) or daunorubicin.\n      * For subjects assigned to non intensive chemotherapy, documented or suspected hypersensitivity to azacitidine or mannitol.\n     \n     \n 16. Known active drug or alcohol abuse.\n 17. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.\n 18. Pregnant females or breastfeeding female subjects.\n 19. Known recent or active suicidal ideation or behavior.\n 20. Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.","FSH",null,"Protein","Ovary","Actual","2018-01-31","Actual","Anticipated","2025-07-22","Anticipated","2018-12-01","2017-12-21","2018-01-23","2018-12-16","Yes","glasdegib;\nuntreated;\nHedgehog Inhibitor","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"All",null,"No","Yes\nInformation relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests",null,"URL: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1371019&StudyName=A+Randomized+%281%3A1%29%2C+Double+Blind%2C+Multi+Center%2C+Placebo+Controlled+Study+Evaluating+Intensive+Chemotherapy+With+Or+Without+Glasdegib+%28pf+04449913%29+Or+Azacitidine+%28aza%29+With+Or+Without+Glasdegib+In+Patients+With+Previously+Untreated+Acute+Myeloid+Leukemia [https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1371019&StudyName=A+Randomized+%281%3A1%29%2C+Double+Blind%2C+Multi+Center%2C+Placebo+Controlled+Study+Evaluating+Intensive+Chemotherapy+With+Or+Without+Glasdegib+%28pf+04449913%29+Or+Azacitidine+%28aza%29+With+Or+Without+Glasdegib+In+Patients+With+Previously+Untreated+Acute+Myeloid+Leukemia] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To obtain contact information for a study center near you, click here.",null,"Yes","No",{"$nulls":17},"2017-002822-19|BRIGHT|BRIGHT AML1019","EudraCT Number|Alias Study Number","Overall survival","5 years after last subject randomized",null,"Fatigue score measured by the MD Anderson Symptom Inventory (MDASI)-AML/MDS questionnaire|Rate of Complete Remission (CR) (including CR with minimal residual disease (MRD)-negative as assessed by multiparametric flow cytometry)|Duration of response (defined as CR [includes CR-MRD negative]/CRi or CR/CRh as appropriate)|Time to response (CR[includes CR-MRD negative)]/CR with partial hematologic rcovery (CRh) as appropriate)|Event-free Survival|Patient Reported Outcomes (PROs) as measured by the M.D. Anderson Symptom Inventory AML/MDS Module (MDASI-AML/MDS)|Adverse events as graded by NCI CTCAE v4.03|Laboratory abnormalities as graded by NCI CTCAE v4.03|For the intensive study, the plasma trough concentration (Ctrough) will be analyzed|QTc interval|PROs as measured by Patient Global Impression of Change (PGIC)|Patient Reported Outcomes (PROs) as measured by EuroQoL 5 Dimension questionnaire 5-Level version (EQ-5D-5L)|Patient Reported Outcomes (PROs) as measured by Patient Global Impression of Symptoms (PGIS)|Complete Remission with incomplete hematologic recovery (CRi)|Rate of morphological leukemia-free state (MLFS)|Rate of Partial Remission (PR)|Rate of Complete Remission with partial hematological recovery (CRh) for the Non-intensive study only only|Minimum Observed Plasma Trough Concentratrion of glasdegib in the Intensive Study|Minimum Observed Plasma Trough Concentration of glasdegib in the Non-intensive study","Scale is from 0-10 where 0 is not present and 10 is as bad as you can image.|Response as defined by the 2017 European LeukemiaNet (ELN) recommendations.|5 years after last subject randomized, consent withdrawal, or death|Measurement Scale from 0-10.|PK samples taken on Induction(s) Day 1 (1 and 4 hours post induction); Induction(s) Day 10 (pre-dose, 1 and 4 hours post dose); Day 1 of each Consolidation cycle (pre-dose, 1 and 4 hours post dose)|One question asking for description of leukemia symptoms.|Series of questions that ask for information that best describes health.|One question asking for information regarding leukemia symptoms.|Its the minimum trough concentration in plasma of glasdegib following multiple daily dosing to steady state.|It is the minimum trough concentration in plasma of glasdegib following multiple daily dosing to steady state.","5 years after last subject randomized, consent withdrawal, or death|2 years after last dose of study therapy|5 years after last patient randomized, withdrawal, or death|5 years after last subject randomized, withdrawal, or death|Day 10 of Induction Cycle and Day 1 of each Consolidation Cycle|Cycle 1 Day 15 and Cycles 2 and 3 on Day 1","ClinicalTrials.gov_Inquiries@pfizer.com","Pfizer CT.gov Call Center","1-800-718-1021","Adelaide, South|Darlinghurst, New South Wales, Australia, 2010 St George HospitalKogarah, New South Wales, Australia, 2217|Brno, Czechia, 625 00 Nemocnicni LekarnaBrno, Czechia, 625 00 InternÃ­ HematologickÃ¡ Klinika, Fakultni Nemocnice KrÃ¡lovskÃ© VinohradyPraha 10, Czechia, 100 34 Ãšstavni LÃ©kÃ¡rnaPraha 10, Czechia, 100 34|Creteil, France, 94010 Chu Henri MondorCrÃ©teil, France, 94010 Chu De NantesNantes Cedex 1, France, 44093 Chu De Nantes Hotel DieuNantes Cedex, France, 44093 Hopital Saint LouisParis, France, 75010 Centre Hospitalier Lyon Sud -Unite De Pharmacie Clinique OncologiquePierre Benite Cedex, France, 69495 Centre Hospitalier Lyon Sud - Service D'HematologiePierre Benite Cedex, France, 69495|Debrecen, Hungary, 4032 Debreceni Egyetem Klinikai Kozpont Belgyogyaszati KlinikaDebrecen, Hungary, 4032|Ancona, An, Italy, 60126|Cona, Ferrara, Fe, Italy, 44124 Farmacia OspedalieraFerrara, Fe, Italy, 44121|Nagoya, Aichi, Japan, 466-8650|Akita, Japan, 010-8543 Kyushu University HospitalFukuoka, Japan, 812-8582 National Hospital Organization Kumamoto Medical Center[Active, Not Recruiting]Kumamoto, Japan, 860-0008 Nagasaki University HospitalNagasaki, Japan, 852-8501 Tokyo Medical University HospitalTokyo, Japan, 160-0023 Korea, Republic Of, Jeollabuk-Do Chonbuk National University HospitalJeonju-Si, Jeollabuk-Do, Korea, Republic Of, 54907 Korea, Republic Of, Jeollanam-Do Chonnam National University Hwasun HospitalHwasun-Gun, Jeollanam-Do, Korea, Republic Of, 58128 Korea, Republic Of Department Of Pharmacy, Inje University Busan Paik HospitalBusan, Korea, Republic Of, 47392 Inje University Busan Paik HospitalBusan, Korea, Republic Of, 47392 Clinical Trial Pharmacy, Keimyung University Dongsan HospitalDaegu, Korea, Republic Of, 41931 Keimyung University Dongsan HospitalDaegu, Korea, Republic Of, 41931 Gachon University Gil Medical CenterIncheon, Korea, Republic Of, 21565 Seoul National University HospitalSeoul, Korea, Republic Of, 03080 Clinical Trial Center, Severance Hospital, Yonsei University Health System (Drug Shipment Only)Seoul, Korea, Republic Of, 03722 Severance Hospital, Yonsei University Health SystemSeoul, Korea, Republic Of, 03722 Department Of Pharmacy, Samsung Medical CenterSeoul, Korea, Republic Of, 06351 Samsung Medical CenterSeoul, Korea, Republic Of, 06351 The Catholic University Of Korea Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591 The Catholic University Of Korea, Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591|Yoshida-Gun, Fukui, Japan, 910-1193|Maebashi, Gunma, Japan, 371-8511|Kobe-Shi, Hyogo, Japan, 650-0017|Yokohama, Kanagawa, Japan, 232-0024|Sendai, Miyagi, Japan, 980-8574|Osaka-City, Osaka, Japan, 545-8586 Kindai University HospitalOsaka-Sayama, Osaka, Japan, 589-8511|Sunto-Gun, Shizuoka, Japan, 411-8777|Tachikawa, Tokyo, Japan, 190-0014|Gdansk, Poland, 80-952|Craiova, Dolj, Romania, 200143|Bucuresti, Romania, 030171 Russian Federation Sbhi Cch No. 40 Hd MoscowMoscow, Russian Federation, 129301 State Budgetary Healthcare Institution Of MoscowMoscow, Russian Federation, 129301 Sbhi Nnr Nn Rch N. A. N.A. SemashkoNizhniy Novgorod, Russian Federation, 603126 State Budgetary Institution Of Ryazan Region 'Regional Clinical Hospital' (Sbi Rr Rch)Ryazan, Russian Federation, 390039 Drug Shipment Address:Saint Petersburg, Russian Federation, 191024 Fsbi Russrhti Fmba Of|Barcelona, Spain, 08003 Hospital De La Santa Creu I Sant PauBarcelona, Spain, 08025 Hospital Universitario Arnau De VilanovaLleida, Spain, 25198 Hospital General Universitario Gregorio MaranonMadrid, Spain, 28007 Hospital Universitario Ramon Y CajalMadrid, Spain, 28034 Hospital Universitario Virgen Del RocioSevilla, Spain, 41013 Hospital Universitari I Politecnic La FeValencia, Spain, 46026 Taiwan Department Of Clinical Trial Pharmacy, Taipei Veterans General HospitalTaipei, Taiwan, 11217 Taipei Veterans General HospitalTaipei, Taiwan, 11217 Division Of Pharmacy, Koo Foundation Sun Yat-Sen Cancer CenterTaipei, Taiwan, 112 Koo Foundation Sun Yat-Sen Cancer CenterTaipei, Taiwan, 112 Chang Gung Memorial Hospital-Linkou BranchTaoyuan City, Taiwan, 333 Chemotherapy Pharmacy, Chang Gung Memorial Hospital-Linkou BranchTaoyuan City, Taiwan, 333|Sutton, Surrey, United Kingdom, Sm2 5Pt|Los Angeles, California, United States, 90095 Ucla Department Of MedicineLos Angeles, California, United States, 90095 Ucla Hematology/Oncology ClinicLos Angeles, California, United States, 90095 Ucla Ronald Reagan Medical CenterLos Angeles, California, United States, 90095 Uc Irvine Health - Chao Family Comprehensive Cancer CenterOrange, California, United States, 92868-3201 Uc Irvine Medical CenterOrange, California, United States, 92868-3201 Ucsf Helen Diller Family Comprehensive Cancer CenterSan Francisco, California, United States, 94143 University Of California, San Francisco Medical CenterSan Francisco, California, United States, 94143 University Of California, San FranciscoSan Francisco, California, United States, 94143|Kansas City, Missouri, United States, 64132|Lake Success, New York, United States, 11042 North Shore University HospitalManhasset, New York, United States, 11030 Long Island Jewish Medical CenterNew Hyde Park, New York, United States, 11040 University Of Rochester Cancer Center PharmacyRochester, New York, United States, 14642 University Of Rochester Medical CenterRochester, New York, United States, 14642|Cleveland, Ohio, United States, 44106 University Hospitals Cleveland Medical CenterCleveland, Ohio, United States, 44106 Cleveland Clinic FoundationCleveland, Ohio, United States, 44195|Nashville, Tennessee, United States, 37203|Dallas, Texas, United States, 75246 Baylor University Medical CenterDallas, Texas, United States, 75246 Blood Cancer And Stem Cell Transplant ClinicSan Antonio, Texas, United States, 78229 Methodist Healthcare System Of San AntonioSan Antonio, Texas, United States, 78229 Methodist Hospital Investigational PharmacySan Antonio, Texas, United States, 78229|Seattle, Washington, United States, 98104 Swedish Investigational Drug Services PharmacySeattle, Washington, United States, 98104 Swedish Medical CenterSeattle, Washington, United States, 98122","California|Missouri|New York|Ohio|Tennessee|Texas|Washington","Australia|Czechia|France|Hungary|Italy|Japan|Poland|Romania|Spain|United Kingdom|United States","Australia, 5000 Royal Adelaide Hospital - Clinical Trials Pharmacy|Haematology And Bone Marrow Transplant Unit, Royal Adelaide Hospital|New South Wales St Vincent's Hospital Sydney|Interni Hematologicka A Onkologicka Klinika, Fakultni Nemocnice Brno|Chu Henri Mondor|Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Klinika, Hematologia Tanszek|An Aou Ospedali Riuniti Umberto I, G.M. Lancisi, G. Salesi, Clinica Di Ematologia|Fe A.O.U. Di Ferrara- Arcispedale Sant'Anna,|Aichi Japanese Red Cross Nagoya Daini Hospital|Akita University Hospital|Fukui University Of Fukui Hospital|Gunma Gunma University Hospital|Hyogo Kobe University Hospital|Kanagawa Yokohama City University Medical Center|Miyagi Tohoku University Hospital|Osaka Osaka City University Hospital|Shizuoka Shizuoka Cancer Center|Tokyo National Hospital Organization Disaster Medical Center|Klinika Hematologii I Transplantologii Uniwersyteckie Centrum Kliniczne|Dolj Spitalul Clinic Municipal Filantropia Craiova, Sectia Clinica Hematologie|Spitalul Clinic Coltea, Clinica De Hematologie|Hospital Del Mar|, Surrey The Royal Marsden Nhs Foundation Trust|Rrmc - Ucla|Midamerica Division, Inc., C/O Research Medical Center|Northwell Health/Monter Cancer Center|Taussig Cancer Center Investigational Pharmacy|The Sarah Cannon Research Institute|Baylor Scott And White Research Institute|Swedish Cancer Institute",{"$nulls":3},"Pfizer CT.gov Call Center","2018-12-16","2020-05-25T16:39:31.001","2020-05-26T17:10:42.972","NCT03416179"]
["5ecbf4c3feab101b155309e6","NCT03416179","2019-01-03","Pfizer","PFE","Recruiting","A Study Evaluating Intensive Chemotherapy With or Without Glasdegib or Azacitidine With or Without Glasdegib In Patients With Previously Untreated Acute Myeloid Leukemia (BRIGHT AML1019)","Glasdegib|Cytarabine|Daunorubicin|Azacitidine","Hh Inhibitor|DNA Polymerase Inhibitor|Nucleic Acid Synthesis Inhibitor|TOP2 Inhibitor|DNA Mtase Inhibitor","Unknown",null,"Unknown",null,"Phase 3",4,720,"Anticipated","2018-04-20","2021-06-13","OS","Overall Survival",{"$nulls":3},"Glasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).\n\nGlasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).","Two separate registration trials conducted under one protocol number are proposed to adequately and independently evaluate the addition of glasdegib in intensive and non-intensive chemotherapy populations. Each study will have an experimental treatment arm and a placebo arm. Endpoints are the same for each study except where specifically indicated.\n\nAssignment to the Intensive Study or the Non-Intensive Study will be made by the Investigator based on the 2017 European LeukemiaNet (ELN) recommendations.\n\nStudy B1371019 is a randomized (1:1), double-blind, multi-center, placebo controlled study of chemotherapy in combination with glasdegib versus chemotherapy in combination with placebo in adult patients with previously untreated AML.\n\nGlasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).\n\nGlasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).","A RANDOMIZED (1:1), DOUBLE-BLIND, MULTI-CENTER, PLACEBO CONTROLLED STUDY EVALUATING INTENSIVE CHEMOTHERAPY WITH OR WITHOUT GLASDEGIB (PF-04449913) OR AZACITIDINE (AZA) WITH OR WITHOUT GLASDEGIB IN PATIENTS WITH PREVIOUSLY UNTREATED ACUTE MYELOID LEUKEMIA","B1371019","Leukemia, Myeloid, Acute","Acute Leukemia|Acute Myeloid Leukemia|Myeloid Leukemia|Leukemia","Oncology Hematological","Oncology","Experimental|Placebo Comparator","Arm A (Intensive Study)|Arm B (Intensive Study)|Arm A (Non-intensive study)|Arm B (Non-intensive study)","Glasdegib + '7+3' Induction(s)|Placebo + '7+3' Induction(s)|Glasdegib + azacitidine|Placebo + azacitidine","Drug|Procedure","glasdegib|daunorubicin + cytarabine|cytarabine|HSCT|Placebo|azacitidine","Daily Glasdegib (100 mg, PO), beginning on Day 1 and is to continue up to 2 years post randomization.\n\nFollowing consolidation therapy, glasdegib or placebo will be administered daily for up to 2 years after randomization or until they have minimal residual disease (MRD) negative disease, whichever comes first.\n\nDaily Glasdegib (100 mg, PO) or matching placebo will continue throughout Induction(s) and Consolidation therapies regardless of dose modifications/delays in the chemotherapy.|Consolidation with single agent cytarabine 3 g/m2 IV for adults <60 years and 1 g/m2 for adults 60 years over 3 BID on Days 1, 3, and 5, every 28 days for up to 4 cycles or alternative single agent cytarabine consolidation schedules may be used per local prescribing information.|If required, and done per standard of care post Induction(s).|Azacitidine (75 mg/m2, SC or IV) daily for 7 days, in 28 day cycles for as long as they do not meet the criteria for disease progression, unacceptable toxicity, consent withdrawal, or death.|Matching placebo (PO) is to be administered by mouth daily beginning on Day 1 of chemotherapy and will continue if subjects demonstrate reasonable evidence of clinical benefit and do not meet the criteria for progression regardless of any delays/modifications in the chemotherapy treatment. Subjects will continue placebo until disease progression, unacceptable toxicity, consent withdrawal, or death, whichever comes first.","PF-04449913","Arm A (Intensive Study)|Arm B (Intensive Study)|Arm A (Non-intensive study)|Arm B (Non-intensive study)","\n\nSubjects must meet all of the following inclusion criteria to be eligible for enrollment into the Intensive and Non Intensive study (unless where indicated):\n\n 1.  Subjects with untreated AML according to the World Health Organization (WHO) 2016 Classification2, including those with: * AML arising from MDS or another antecedent hematologic disease (AHD).\n      * AML after previous cytotoxic therapy or radiation (secondary AML).\n     \n     \n 2.  18 years of age (In Japan, 20 years of age).\n 3.  Adequate Organ Function as defined by the following: * Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) 3 x upper limit of normal (ULN), excluding subjects with liver function abnormalities due to underlying malignancy.\n      * Total serum bilirubin 2 x ULN (except subjects with documented Gilbert's syndrome).\n      * Estimated creatinine clearance 30 mL/min as calculated using the standard method for the institution.\n     \n     \n 4.  QTc interval 470 msec using the Fridericia correction (QTcF).\n 5.  All anti cancer treatments (unless specified) should be discontinued 2 weeks from study entry, for example: targeted chemotherapy, radiotherapy, investigational agents, hormones, anagrelide or cytokines. * For control of rapidly progressing leukemia, all trans retinoic acid (ATRA), hydroxyurea, and/or leukopheresis may be used before and for up to 1 week after the first dose of glasdegib.\n     \n     \n 6.  Serum or urine pregnancy test (for female subjects of childbearing potential) with a minimum sensitivity of 25 IU/L or equivalent units of human chorionic gonadotropin (hCG) negative at screening.\n 7.  Male and female subjects of childbearing potential and at risk for pregnancy must agree to use at least one highly effective method of contraception throughout the study and for 180 days after the last dose of azacitidine, cytarabine, or daunorubicin; and the last dose of glasdegib or placebo, whichever occurs later.\n 8.  Female subjects of non childbearing potential must meet at least 1 of the following criteria: 1. Have undergone a documented hysterectomy and/or bilateral oophorectomy;\n      2. Have medically confirmed ovarian failure; or\n      3. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; status may be confirmed by having a serum follicle stimulating hormone (FSH) level confirming the postmenopausal state.\n     \n     All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential.\n     \n     \n 9.  Consent to a saliva sample collection for a germline comparator, unless prohibited by local regulations or ethics committee (EC) decision.\n 10. Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.\n 11. Subjects who are willing and able to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures (including bone marrow [BM] assessments).\n\n","\n\nSubjects with any of the following characteristics/conditions will not be included in the study:\n\n 1.  Acute Promyelocytic Leukemia (APL) and APLwith PML RARA, subjects (WHO 2016 classification).\n 2.  AML with BCR ABL1 or t(9;22)(q34;q11.2) as a sole abnormality. * Complex genetics may include t(9;22) cytogenetic translocation.\n     \n     \n 3.  Subjects with known active CNS leukemia.\n 4.  Participation in other clinical studies involving other investigational drug(s) (Phases 1 4) within 4 weeks prior study entry and/or during study participation.\n 5.  Subjects known to be refractory to platelet or packed red cell transfusions per Institutional Guidelines, or a patient who refuses blood product support.\n 6.  Subjects with another active malignancy on treatment with the exception of basal cell carcinoma, non melanoma skin cancer, cervical carcinoma in situ. Other prior or concurrent malignancies will be considered on a case by case basis.\n 7.  Any one of the following ongoing or in the previous 6 months: myocardial infarction, congenital long QT syndrome, Torsades de pointes, symptomatic arrhythmias (including sustained ventricular tachyarrhythmia), right or left bundle branch block and bifascicular block, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (CHF New York Heart Association class III or IV), cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism; as well as bradycardia defined as <50 bpms.\n 8.  Subjects with an active, life threatening or clinically significant uncontrolled systemic infection not related to AML.\n 9.  Subjects with left ventricular ejection fraction (LVEF) <50% are excluded from the Intensive Chemotherapy Study only.\n 10. Cumulative anthracycline dose equivalent of 550 mg/m2 of daunorubicin for the Intensive Chemotherapy Study only.\n 11. Known malabsorption syndrome or other condition that may significantly impair absorption of study medication in the investigator's judgment (eg, gastrectomy, lap band, Crohn's disease) and inability or unwillingness to swallow tablets or capsules.\n 12. Current use or anticipated requirement for drugs that are known strong CYP3A4/5 inducers.\n 13. Concurrent administration of herbal preparations.\n 14. Major surgery or radiation within 4 weeks of starting study treatment.\n 15. Documented or suspected hypersensitivity to any one of the following: * For subjects assigned to intensive chemotherapy, documented or suspected hypersensitivity to cytarabine (not including drug fever or exanthema, including known cerebellar side effects) or daunorubicin.\n      * For subjects assigned to non intensive chemotherapy, documented or suspected hypersensitivity to azacitidine or mannitol.\n     \n     \n 16. Known active drug or alcohol abuse.\n 17. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.\n 18. Pregnant females or breastfeeding female subjects.\n 19. Known recent or active suicidal ideation or behavior.\n 20. Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.","FSH",null,"Protein","Ovary","Actual","2018-01-31","Actual","Anticipated","2025-07-22","Anticipated","2019-01-01","2017-12-21","2018-01-23","2019-01-01","Yes","glasdegib;\nuntreated;\nHedgehog Inhibitor","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"All",null,"No","Yes\nPfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",null,"URL: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1371019&StudyName=A+Randomized+%281%3A1%29%2C+Double+Blind%2C+Multi+Center%2C+Placebo+Controlled+Study+Evaluating+Intensive+Chemotherapy+With+Or+Without+Glasdegib+%28pf+04449913%29+Or+Azacitidine+%28aza%29+With+Or+Without+Glasdegib+In+Patients+With+Previously+Untreated+Acute+Myeloid+Leukemia [https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1371019&StudyName=A+Randomized+%281%3A1%29%2C+Double+Blind%2C+Multi+Center%2C+Placebo+Controlled+Study+Evaluating+Intensive+Chemotherapy+With+Or+Without+Glasdegib+%28pf+04449913%29+Or+Azacitidine+%28aza%29+With+Or+Without+Glasdegib+In+Patients+With+Previously+Untreated+Acute+Myeloid+Leukemia] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To obtain contact information for a study center near you, click here.",null,"Yes","No",{"$nulls":17},"2017-002822-19|BRIGHT|BRIGHT AML1019","EudraCT Number|Alias Study Number","Overall survival","5 years after last subject randomized",null,"Fatigue score measured by the MD Anderson Symptom Inventory (MDASI)-AML/MDS questionnaire|Rate of Complete Remission (CR) (including CR with minimal residual disease (MRD)-negative as assessed by multiparametric flow cytometry)|Duration of response (defined as CR [includes CR-MRD negative]/CRi or CR/CRh as appropriate)|Time to response (CR[includes CR-MRD negative)]/CR with partial hematologic rcovery (CRh) as appropriate)|Event-free Survival|Patient Reported Outcomes (PROs) as measured by the M.D. Anderson Symptom Inventory AML/MDS Module (MDASI-AML/MDS)|Adverse events as graded by NCI CTCAE v4.03|Laboratory abnormalities as graded by NCI CTCAE v4.03|For the intensive study, the plasma trough concentration (Ctrough) will be analyzed|QTc interval|PROs as measured by Patient Global Impression of Change (PGIC)|Patient Reported Outcomes (PROs) as measured by EuroQoL 5 Dimension questionnaire 5-Level version (EQ-5D-5L)|Patient Reported Outcomes (PROs) as measured by Patient Global Impression of Symptoms (PGIS)|Complete Remission with incomplete hematologic recovery (CRi)|Rate of morphological leukemia-free state (MLFS)|Rate of Partial Remission (PR)|Rate of Complete Remission with partial hematological recovery (CRh) for the Non-intensive study only only|Minimum Observed Plasma Trough Concentratrion of glasdegib in the Intensive Study|Minimum Observed Plasma Trough Concentration of glasdegib in the Non-intensive study","Scale is from 0-10 where 0 is not present and 10 is as bad as you can image.|Response as defined by the 2017 European LeukemiaNet (ELN) recommendations.|5 years after last subject randomized, consent withdrawal, or death|Measurement Scale from 0-10.|PK samples taken on Induction(s) Day 1 (1 and 4 hours post induction); Induction(s) Day 10 (pre-dose, 1 and 4 hours post dose); Day 1 of each Consolidation cycle (pre-dose, 1 and 4 hours post dose)|One question asking for description of leukemia symptoms.|Series of questions that ask for information that best describes health.|One question asking for information regarding leukemia symptoms.|Its the minimum trough concentration in plasma of glasdegib following multiple daily dosing to steady state.|It is the minimum trough concentration in plasma of glasdegib following multiple daily dosing to steady state.","5 years after last subject randomized, consent withdrawal, or death|2 years after last dose of study therapy|5 years after last patient randomized, withdrawal, or death|5 years after last subject randomized, withdrawal, or death|Day 10 of Induction Cycle and Day 1 of each Consolidation Cycle|Cycle 1 Day 15 and Cycles 2 and 3 on Day 1","ClinicalTrials.gov_Inquiries@pfizer.com","Pfizer CT.gov Call Center","1-800-718-1021","Adelaide, South|Darlinghurst, New South Wales, Australia, 2010 St George HospitalKogarah, New South Wales, Australia, 2217|Brno, Czechia, 625 00 Nemocnicni LekarnaBrno, Czechia, 625 00 InternÃ­ HematologickÃ¡ Klinika, Fakultni Nemocnice KrÃ¡lovskÃ© VinohradyPraha 10, Czechia, 100 34 Ãšstavni LÃ©kÃ¡rnaPraha 10, Czechia, 100 34|Creteil, France, 94010 Chu Henri MondorCrÃ©teil, France, 94010 Chu De NantesNantes Cedex 1, France, 44093 Chu De Nantes Hotel DieuNantes Cedex, France, 44093 Hopital Saint LouisParis, France, 75010 Centre Hospitalier Lyon Sud -Unite De Pharmacie Clinique OncologiquePierre Benite Cedex, France, 69495 Centre Hospitalier Lyon Sud - Service D'HematologiePierre Benite Cedex, France, 69495|Debrecen, Hungary, 4032 Debreceni Egyetem Klinikai Kozpont Belgyogyaszati KlinikaDebrecen, Hungary, 4032|Ancona, An, Italy, 60126|Cona, Ferrara, Fe, Italy, 44124 Farmacia OspedalieraFerrara, Fe, Italy, 44121|Nagoya, Aichi, Japan, 466-8650|Akita, Japan, 010-8543 Kyushu University HospitalFukuoka, Japan, 812-8582 National Hospital Organization Kumamoto Medical Center[Active, Not Recruiting]Kumamoto, Japan, 860-0008 Nagasaki University HospitalNagasaki, Japan, 852-8501 Tokyo Medical University HospitalTokyo, Japan, 160-0023 Korea, Republic Of, Jeollabuk-Do Chonbuk National University HospitalJeonju-Si, Jeollabuk-Do, Korea, Republic Of, 54907 Korea, Republic Of, Jeollanam-Do Chonnam National University Hwasun HospitalHwasun-Gun, Jeollanam-Do, Korea, Republic Of, 58128 Korea, Republic Of Department Of Pharmacy, Inje University Busan Paik HospitalBusan, Korea, Republic Of, 47392 Inje University Busan Paik HospitalBusan, Korea, Republic Of, 47392 Clinical Trial Pharmacy, Keimyung University Dongsan HospitalDaegu, Korea, Republic Of, 41931 Keimyung University Dongsan HospitalDaegu, Korea, Republic Of, 41931 Gachon University Gil Medical CenterIncheon, Korea, Republic Of, 21565 Seoul National University HospitalSeoul, Korea, Republic Of, 03080 Severance Hospital, Yonsei University Health SystemSeoul, Korea, Republic Of, 03722 Department Of Pharmacy, Samsung Medical CenterSeoul, Korea, Republic Of, 06351 Samsung Medical CenterSeoul, Korea, Republic Of, 06351 The Catholic University Of Korea Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591 The Catholic University Of Korea, Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591|Yoshida-Gun, Fukui, Japan, 910-1193|Maebashi, Gunma, Japan, 371-8511|Kobe-Shi, Hyogo, Japan, 650-0017|Yokohama, Kanagawa, Japan, 232-0024|Sendai, Miyagi, Japan, 980-8574|Osaka-City, Osaka, Japan, 545-8586 Kindai University HospitalOsaka-Sayama, Osaka, Japan, 589-8511|Sunto-Gun, Shizuoka, Japan, 411-8777|Tachikawa, Tokyo, Japan, 190-0014|Gdansk, Poland, 80-952|Craiova, Dolj, Romania, 200136|Bucuresti, Romania, 030171 Russian Federation Sbhi Cch No. 40 Hd MoscowMoscow, Russian Federation, 129301 State Budgetary Healthcare Institution Of MoscowMoscow, Russian Federation, 129301 Sbhi Nnr Nn Rch N. A. N.A. SemashkoNizhniy Novgorod, Russian Federation, 603126 State Budgetary Institution Of Ryazan Region 'Regional Clinical Hospital' (Sbi Rr Rch)Ryazan, Russian Federation, 390039 Fsbi Russrhti Fmba Of|Barcelona, Spain, 08003 Hospital De La Santa Creu I Sant PauBarcelona, Spain, 08025 Hospital Universitario Arnau De VilanovaLleida, Spain, 25198 Hospital General Universitario Gregorio MaranonMadrid, Spain, 28007 Hospital Universitario Ramon Y CajalMadrid, Spain, 28034 Hospital Universitario Virgen Del RocioSevilla, Spain, 41013 Hospital Universitari I Politecnic La FeValencia, Spain, 46026|Orebro, Sweden, 701 85 Universitetssjukhuset OrebroOrebro, Sweden, 701 85 Taiwan Department Of Clinical Trial Pharmacy, Taipei Veterans General HospitalTaipei, Taiwan, 11217 Taipei Veterans General HospitalTaipei, Taiwan, 11217 Division Of Pharmacy, Koo Foundation Sun Yat-Sen Cancer CenterTaipei, Taiwan, 112 Koo Foundation Sun Yat-Sen Cancer CenterTaipei, Taiwan, 112 Chang Gung Memorial Hospital-Linkou BranchTaoyuan City, Taiwan, 333 Chemotherapy Pharmacy, Chang Gung Memorial Hospital-Linkou BranchTaoyuan City, Taiwan, 333|Sutton, Surrey, United Kingdom, Sm2 5Pt|London, United Kingdom, W12 0Hs|Los Angeles, California, United States, 90033 Lac+Usc Medical CenterLos Angeles, California, United States, 90033 Usc/Norris Comprehensive Cancer Center / Investigational Drug ServicesLos Angeles, California, United States, 90033 Usc/Norris Comprehensive Cancer CenterLos Angeles, California, United States, 90033 Rrmc - UclaLos Angeles, California, United States, 90095 Ucla Department Of MedicineLos Angeles, California, United States, 90095 Ucla Hematology/Oncology ClinicLos Angeles, California, United States, 90095 Ucla Ronald Reagan Medical CenterLos Angeles, California, United States, 90095 Keck Medicine Of Usc Norris Oncology/Hematology - Newport Beach Treatment CenterNewport Beach, California, United States, 92663 Usc Norris Oncology/Hematology - Newport BeachNewport Beach, California, United States, 92663 Uc Irvine Health - Chao Family Comprehensive Cancer CenterOrange, California, United States, 92868-3201 Uc Irvine Medical CenterOrange, California, United States, 92868-3201 Ucsf Helen Diller Family Comprehensive Cancer CenterSan Francisco, California, United States, 94143 University Of California, San Francisco Medical CenterSan Francisco, California, United States, 94143 University Of California, San FranciscoSan Francisco, California, United States, 94143|Kansas City, Missouri, United States, 64132|Lake Success, New York, United States, 11042 North Shore University HospitalManhasset, New York, United States, 11030 Long Island Jewish Medical CenterNew Hyde Park, New York, United States, 11040 University Of Rochester Cancer Center PharmacyRochester, New York, United States, 14642 University Of Rochester Medical CenterRochester, New York, United States, 14642|Cleveland, Ohio, United States, 44106 University Hospitals Cleveland Medical CenterCleveland, Ohio, United States, 44106 Cleveland Clinic FoundationCleveland, Ohio, United States, 44195|Nashville, Tennessee, United States, 37203|Dallas, Texas, United States, 75246 Baylor University Medical CenterDallas, Texas, United States, 75246 Blood Cancer And Stem Cell Transplant ClinicSan Antonio, Texas, United States, 78229 Methodist Healthcare System Of San AntonioSan Antonio, Texas, United States, 78229 Methodist Hospital Investigational PharmacySan Antonio, Texas, United States, 78229|Seattle, Washington, United States, 98104 Swedish Investigational Drug Services PharmacySeattle, Washington, United States, 98104 Swedish Medical CenterSeattle, Washington, United States, 98122","California|Missouri|New York|Ohio|Tennessee|Texas|Washington","Australia|Czechia|France|Hungary|Italy|Japan|Poland|Romania|Spain|Sweden|United Kingdom|United States","Australia, 5000 Royal Adelaide Hospital - Clinical Trials Pharmacy|Haematology And Bone Marrow Transplant Unit, Royal Adelaide Hospital|New South Wales St Vincent's Hospital Sydney|Interni Hematologicka A Onkologicka Klinika, Fakultni Nemocnice Brno|Chu Henri Mondor|Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Klinika, Hematologia Tanszek|An Aou Ospedali Riuniti Umberto I, G.M. Lancisi, G. Salesi, Clinica Di Ematologia|Fe A.O.U. Di Ferrara- Arcispedale Sant'Anna,|Aichi Japanese Red Cross Nagoya Daini Hospital|Akita University Hospital|Fukui University Of Fukui Hospital|Gunma Gunma University Hospital|Hyogo Kobe University Hospital|Kanagawa Yokohama City University Medical Center|Miyagi Tohoku University Hospital|Osaka Osaka City University Hospital|Shizuoka Shizuoka Cancer Center|Tokyo National Hospital Organization Disaster Medical Center|Klinika Hematologii I Transplantologii Uniwersyteckie Centrum Kliniczne|Dolj Spitalul Clinic Municipal Filantropia Craiova, Sectia Clinica Hematologie|Spitalul Clinic Coltea, Clinica De Hematologie|Hospital Del Mar|Apoex Vn|, Surrey The Royal Marsden Nhs Foundation Trust|Imperial College Healthcare Nhs Trust|Keck Hospital Of Usc|Midamerica Division, Inc., C/O Research Medical Center|Northwell Health/Monter Cancer Center|Taussig Cancer Center Investigational Pharmacy|The Sarah Cannon Research Institute|Baylor Scott And White Research Institute|Swedish Cancer Institute",{"$nulls":3},"Pfizer CT.gov Call Center","2019-01-01","2020-05-25T16:39:31.571","2020-05-26T17:10:42.972","NCT03416179"]
["5ecbf4c4307e3d1b1f8d9e49","NCT03416179","2019-01-08","Pfizer","PFE","Recruiting","A Study Evaluating Intensive Chemotherapy With or Without Glasdegib or Azacitidine With or Without Glasdegib In Patients With Previously Untreated Acute Myeloid Leukemia (BRIGHT AML1019)","Glasdegib|Cytarabine|Daunorubicin|Azacitidine","Hh Inhibitor|DNA Polymerase Inhibitor|Nucleic Acid Synthesis Inhibitor|TOP2 Inhibitor|DNA Mtase Inhibitor","Unknown",null,"Unknown",null,"Phase 3",4,720,"Anticipated","2018-04-20","2021-06-13","OS","Overall Survival",{"$nulls":3},"Glasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).\n\nGlasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).","Two separate registration trials conducted under one protocol number are proposed to adequately and independently evaluate the addition of glasdegib in intensive and non-intensive chemotherapy populations. Each study will have an experimental treatment arm and a placebo arm. Endpoints are the same for each study except where specifically indicated.\n\nAssignment to the Intensive Study or the Non-Intensive Study will be made by the Investigator based on the 2017 European LeukemiaNet (ELN) recommendations.\n\nStudy B1371019 is a randomized (1:1), double-blind, multi-center, placebo controlled study of chemotherapy in combination with glasdegib versus chemotherapy in combination with placebo in adult patients with previously untreated AML.\n\nGlasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).\n\nGlasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).","A RANDOMIZED (1:1), DOUBLE-BLIND, MULTI-CENTER, PLACEBO CONTROLLED STUDY EVALUATING INTENSIVE CHEMOTHERAPY WITH OR WITHOUT GLASDEGIB (PF-04449913) OR AZACITIDINE (AZA) WITH OR WITHOUT GLASDEGIB IN PATIENTS WITH PREVIOUSLY UNTREATED ACUTE MYELOID LEUKEMIA","B1371019","Leukemia, Myeloid, Acute","Acute Leukemia|Acute Myeloid Leukemia|Myeloid Leukemia|Leukemia","Oncology Hematological","Oncology","Experimental|Placebo Comparator","Arm A (Intensive Study)|Arm B (Intensive Study)|Arm A (Non-intensive study)|Arm B (Non-intensive study)","Glasdegib + '7+3' Induction(s)|Placebo + '7+3' Induction(s)|Glasdegib + azacitidine|Placebo + azacitidine","Drug|Procedure","glasdegib|daunorubicin + cytarabine|cytarabine|HSCT|Placebo|azacitidine","Daily Glasdegib (100 mg, PO), beginning on Day 1 and is to continue up to 2 years post randomization.\n\nFollowing consolidation therapy, glasdegib or placebo will be administered daily for up to 2 years after randomization or until they have minimal residual disease (MRD) negative disease, whichever comes first.\n\nDaily Glasdegib (100 mg, PO) or matching placebo will continue throughout Induction(s) and Consolidation therapies regardless of dose modifications/delays in the chemotherapy.|Consolidation with single agent cytarabine 3 g/m2 IV for adults <60 years and 1 g/m2 for adults 60 years over 3 BID on Days 1, 3, and 5, every 28 days for up to 4 cycles or alternative single agent cytarabine consolidation schedules may be used per local prescribing information.|If required, and done per standard of care post Induction(s).|Azacitidine (75 mg/m2, SC or IV) daily for 7 days, in 28 day cycles for as long as they do not meet the criteria for disease progression, unacceptable toxicity, consent withdrawal, or death.|Matching placebo (PO) is to be administered by mouth daily beginning on Day 1 of chemotherapy and will continue if subjects demonstrate reasonable evidence of clinical benefit and do not meet the criteria for progression regardless of any delays/modifications in the chemotherapy treatment. Subjects will continue placebo until disease progression, unacceptable toxicity, consent withdrawal, or death, whichever comes first.","PF-04449913","Arm A (Intensive Study)|Arm B (Intensive Study)|Arm A (Non-intensive study)|Arm B (Non-intensive study)","\n\nSubjects must meet all of the following inclusion criteria to be eligible for enrollment into the Intensive and Non Intensive study (unless where indicated):\n\n 1.  Subjects with untreated AML according to the World Health Organization (WHO) 2016 Classification2, including those with: * AML arising from MDS or another antecedent hematologic disease (AHD).\n      * AML after previous cytotoxic therapy or radiation (secondary AML).\n     \n     \n 2.  18 years of age (In Japan, 20 years of age).\n 3.  Adequate Organ Function as defined by the following: * Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) 3 x upper limit of normal (ULN), excluding subjects with liver function abnormalities due to underlying malignancy.\n      * Total serum bilirubin 2 x ULN (except subjects with documented Gilbert's syndrome).\n      * Estimated creatinine clearance 30 mL/min as calculated using the standard method for the institution.\n     \n     \n 4.  QTc interval 470 msec using the Fridericia correction (QTcF).\n 5.  All anti cancer treatments (unless specified) should be discontinued 2 weeks from study entry, for example: targeted chemotherapy, radiotherapy, investigational agents, hormones, anagrelide or cytokines. * For control of rapidly progressing leukemia, all trans retinoic acid (ATRA), hydroxyurea, and/or leukopheresis may be used before and for up to 1 week after the first dose of glasdegib.\n     \n     \n 6.  Serum or urine pregnancy test (for female subjects of childbearing potential) with a minimum sensitivity of 25 IU/L or equivalent units of human chorionic gonadotropin (hCG) negative at screening.\n 7.  Male and female subjects of childbearing potential and at risk for pregnancy must agree to use at least one highly effective method of contraception throughout the study and for 180 days after the last dose of azacitidine, cytarabine, or daunorubicin; and the last dose of glasdegib or placebo, whichever occurs later.\n 8.  Female subjects of non childbearing potential must meet at least 1 of the following criteria: 1. Have undergone a documented hysterectomy and/or bilateral oophorectomy;\n      2. Have medically confirmed ovarian failure; or\n      3. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; status may be confirmed by having a serum follicle stimulating hormone (FSH) level confirming the postmenopausal state.\n     \n     All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential.\n     \n     \n 9.  Consent to a saliva sample collection for a germline comparator, unless prohibited by local regulations or ethics committee (EC) decision.\n 10. Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.\n 11. Subjects who are willing and able to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures (including bone marrow [BM] assessments).\n\n","\n\nSubjects with any of the following characteristics/conditions will not be included in the study:\n\n 1.  Acute Promyelocytic Leukemia (APL) and APLwith PML RARA, subjects (WHO 2016 classification).\n 2.  AML with BCR ABL1 or t(9;22)(q34;q11.2) as a sole abnormality. * Complex genetics may include t(9;22) cytogenetic translocation.\n     \n     \n 3.  Subjects with known active CNS leukemia.\n 4.  Participation in other clinical studies involving other investigational drug(s) (Phases 1 4) within 4 weeks prior study entry and/or during study participation.\n 5.  Subjects known to be refractory to platelet or packed red cell transfusions per Institutional Guidelines, or a patient who refuses blood product support.\n 6.  Subjects with another active malignancy on treatment with the exception of basal cell carcinoma, non melanoma skin cancer, cervical carcinoma in situ. Other prior or concurrent malignancies will be considered on a case by case basis.\n 7.  Any one of the following ongoing or in the previous 6 months: myocardial infarction, congenital long QT syndrome, Torsades de pointes, symptomatic arrhythmias (including sustained ventricular tachyarrhythmia), right or left bundle branch block and bifascicular block, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (CHF New York Heart Association class III or IV), cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism; as well as bradycardia defined as <50 bpms.\n 8.  Subjects with an active, life threatening or clinically significant uncontrolled systemic infection not related to AML.\n 9.  Subjects with left ventricular ejection fraction (LVEF) <50% are excluded from the Intensive Chemotherapy Study only.\n 10. Cumulative anthracycline dose equivalent of 550 mg/m2 of daunorubicin for the Intensive Chemotherapy Study only.\n 11. Known malabsorption syndrome or other condition that may significantly impair absorption of study medication in the investigator's judgment (eg, gastrectomy, lap band, Crohn's disease) and inability or unwillingness to swallow tablets or capsules.\n 12. Current use or anticipated requirement for drugs that are known strong CYP3A4/5 inducers.\n 13. Concurrent administration of herbal preparations.\n 14. Major surgery or radiation within 4 weeks of starting study treatment.\n 15. Documented or suspected hypersensitivity to any one of the following: * For subjects assigned to intensive chemotherapy, documented or suspected hypersensitivity to cytarabine (not including drug fever or exanthema, including known cerebellar side effects) or daunorubicin.\n      * For subjects assigned to non intensive chemotherapy, documented or suspected hypersensitivity to azacitidine or mannitol.\n     \n     \n 16. Known active drug or alcohol abuse.\n 17. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.\n 18. Pregnant females or breastfeeding female subjects.\n 19. Known recent or active suicidal ideation or behavior.\n 20. Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.","FSH",null,"Protein","Ovary","Actual","2018-01-31","Actual","Anticipated","2025-07-22","Anticipated","2019-01-01","2017-12-21","2018-01-23","2019-01-07","Yes","glasdegib;\nuntreated;\nHedgehog Inhibitor","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"All",null,"No","Yes\nPfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",null,"URL: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1371019&StudyName=A+Randomized+%281%3A1%29%2C+Double+Blind%2C+Multi+Center%2C+Placebo+Controlled+Study+Evaluating+Intensive+Chemotherapy+With+Or+Without+Glasdegib+%28pf+04449913%29+Or+Azacitidine+%28aza%29+With+Or+Without+Glasdegib+In+Patients+With+Previously+Untreated+Acute+Myeloid+Leukemia [https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1371019&StudyName=A+Randomized+%281%3A1%29%2C+Double+Blind%2C+Multi+Center%2C+Placebo+Controlled+Study+Evaluating+Intensive+Chemotherapy+With+Or+Without+Glasdegib+%28pf+04449913%29+Or+Azacitidine+%28aza%29+With+Or+Without+Glasdegib+In+Patients+With+Previously+Untreated+Acute+Myeloid+Leukemia] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To obtain contact information for a study center near you, click here.",null,"Yes","No",{"$nulls":17},"2017-002822-19|BRIGHT|BRIGHT AML1019","EudraCT Number|Alias Study Number","Overall survival","5 years after last subject randomized",null,"Fatigue score measured by the MD Anderson Symptom Inventory (MDASI)-AML/MDS questionnaire|Rate of Complete Remission (CR) (including CR with minimal residual disease (MRD)-negative as assessed by multiparametric flow cytometry)|Duration of response (defined as CR [includes CR-MRD negative]/CRi or CR/CRh as appropriate)|Time to response (CR[includes CR-MRD negative)]/CR with partial hematologic rcovery (CRh) as appropriate)|Event-free Survival|Patient Reported Outcomes (PROs) as measured by the M.D. Anderson Symptom Inventory AML/MDS Module (MDASI-AML/MDS)|Adverse events as graded by NCI CTCAE v4.03|Laboratory abnormalities as graded by NCI CTCAE v4.03|For the intensive study, the plasma trough concentration (Ctrough) will be analyzed|QTc interval|PROs as measured by Patient Global Impression of Change (PGIC)|Patient Reported Outcomes (PROs) as measured by EuroQoL 5 Dimension questionnaire 5-Level version (EQ-5D-5L)|Patient Reported Outcomes (PROs) as measured by Patient Global Impression of Symptoms (PGIS)|Complete Remission with incomplete hematologic recovery (CRi)|Rate of morphological leukemia-free state (MLFS)|Rate of Partial Remission (PR)|Rate of Complete Remission with partial hematological recovery (CRh) for the Non-intensive study only only|Minimum Observed Plasma Trough Concentratrion of glasdegib in the Intensive Study|Minimum Observed Plasma Trough Concentration of glasdegib in the Non-intensive study","Scale is from 0-10 where 0 is not present and 10 is as bad as you can image.|Response as defined by the 2017 European LeukemiaNet (ELN) recommendations.|5 years after last subject randomized, consent withdrawal, or death|Measurement Scale from 0-10.|PK samples taken on Induction(s) Day 1 (1 and 4 hours post induction); Induction(s) Day 10 (pre-dose, 1 and 4 hours post dose); Day 1 of each Consolidation cycle (pre-dose, 1 and 4 hours post dose)|One question asking for description of leukemia symptoms.|Series of questions that ask for information that best describes health.|One question asking for information regarding leukemia symptoms.|Its the minimum trough concentration in plasma of glasdegib following multiple daily dosing to steady state.|It is the minimum trough concentration in plasma of glasdegib following multiple daily dosing to steady state.","5 years after last subject randomized, consent withdrawal, or death|2 years after last dose of study therapy|5 years after last patient randomized, withdrawal, or death|5 years after last subject randomized, withdrawal, or death|Day 10 of Induction Cycle and Day 1 of each Consolidation Cycle|Cycle 1 Day 15 and Cycles 2 and 3 on Day 1","ClinicalTrials.gov_Inquiries@pfizer.com","Pfizer CT.gov Call Center","1-800-718-1021","Adelaide, South|Darlinghurst, New South Wales, Australia, 2010 St George HospitalKogarah, New South Wales, Australia, 2217|Brno, Czechia, 625 00 Nemocnicni LekarnaBrno, Czechia, 625 00 InternÃ­ HematologickÃ¡ Klinika, Fakultni Nemocnice KrÃ¡lovskÃ© VinohradyPraha 10, Czechia, 100 34 Ãšstavni LÃ©kÃ¡rnaPraha 10, Czechia, 100 34|Creteil, France, 94010 Chu Henri MondorCrÃ©teil, France, 94010 Chu De NantesNantes Cedex 1, France, 44093 Chu De Nantes Hotel DieuNantes Cedex, France, 44093 Hopital Saint LouisParis, France, 75010 Centre Hospitalier Lyon Sud -Unite De Pharmacie Clinique OncologiquePierre Benite Cedex, France, 69495 Centre Hospitalier Lyon Sud - Service D'HematologiePierre Benite Cedex, France, 69495|Debrecen, Hungary, 4032 Debreceni Egyetem Klinikai Kozpont Belgyogyaszati KlinikaDebrecen, Hungary, 4032|Ancona, An, Italy, 60126|Cona, Ferrara, Fe, Italy, 44124 Farmacia OspedalieraFerrara, Fe, Italy, 44121|Nagoya, Aichi, Japan, 466-8650|Akita, Japan, 010-8543 Kyushu University HospitalFukuoka, Japan, 812-8582 National Hospital Organization Kumamoto Medical Center[Active, Not Recruiting]Kumamoto, Japan, 860-0008 Nagasaki University HospitalNagasaki, Japan, 852-8501 Tokyo Medical University HospitalTokyo, Japan, 160-0023 Korea, Republic Of, Jeollabuk-Do Chonbuk National University HospitalJeonju-Si, Jeollabuk-Do, Korea, Republic Of, 54907 Korea, Republic Of, Jeollanam-Do Chonnam National University Hwasun HospitalHwasun-Gun, Jeollanam-Do, Korea, Republic Of, 58128 Korea, Republic Of Department Of Pharmacy, Inje University Busan Paik HospitalBusan, Korea, Republic Of, 47392 Inje University Busan Paik HospitalBusan, Korea, Republic Of, 47392 Clinical Trial Pharmacy, Keimyung University Dongsan HospitalDaegu, Korea, Republic Of, 41931 Keimyung University Dongsan HospitalDaegu, Korea, Republic Of, 41931 Gachon University Gil Medical CenterIncheon, Korea, Republic Of, 21565 Seoul National University HospitalSeoul, Korea, Republic Of, 03080 Severance Hospital, Yonsei University Health SystemSeoul, Korea, Republic Of, 03722 Department Of Pharmacy, Samsung Medical CenterSeoul, Korea, Republic Of, 06351 Samsung Medical CenterSeoul, Korea, Republic Of, 06351 The Catholic University Of Korea Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591 The Catholic University Of Korea, Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591|Yoshida-Gun, Fukui, Japan, 910-1193|Maebashi, Gunma, Japan, 371-8511|Kobe-Shi, Hyogo, Japan, 650-0017|Yokohama, Kanagawa, Japan, 232-0024|Sendai, Miyagi, Japan, 980-8574|Osaka-City, Osaka, Japan, 545-8586 Kindai University HospitalOsaka-Sayama, Osaka, Japan, 589-8511|Sunto-Gun, Shizuoka, Japan, 411-8777|Tachikawa, Tokyo, Japan, 190-0014|Gdansk, Poland, 80-952 Wwcoit Im. M. Kopernika W LodziLodz, Poland, 93-513|Craiova, Dolj, Romania, 200136|Bucuresti, Romania, 030171 Russian Federation Sbhi Cch No. 40 Hd MoscowMoscow, Russian Federation, 129301 State Budgetary Healthcare Institution Of MoscowMoscow, Russian Federation, 129301 Sbhi Nnr Nn Rch N. A. N.A. SemashkoNizhniy Novgorod, Russian Federation, 603126 State Budgetary Institution Of Ryazan Region 'Regional Clinical Hospital' (Sbi Rr Rch)Ryazan, Russian Federation, 390039 Fsbi Russrhti Fmba Of|Barcelona, Spain, 08003 Hospital De La Santa Creu I Sant PauBarcelona, Spain, 08025 Hospital Universitario Arnau De VilanovaLleida, Spain, 25198 Hospital General Universitario Gregorio MaranonMadrid, Spain, 28007 Hospital Universitario Ramon Y CajalMadrid, Spain, 28034 Hospital Universitario Virgen Del RocioSevilla, Spain, 41013 Hospital Universitari I Politecnic La FeValencia, Spain, 46026|Orebro, Sweden, 701 85 Universitetssjukhuset OrebroOrebro, Sweden, 701 85 Taiwan Department Of Clinical Trial Pharmacy, Taipei Veterans General HospitalTaipei, Taiwan, 11217 Taipei Veterans General HospitalTaipei, Taiwan, 11217 Division Of Pharmacy, Koo Foundation Sun Yat-Sen Cancer CenterTaipei, Taiwan, 112 Koo Foundation Sun Yat-Sen Cancer CenterTaipei, Taiwan, 112 Chang Gung Memorial Hospital-Linkou BranchTaoyuan City, Taiwan, 333 Chemotherapy Pharmacy, Chang Gung Memorial Hospital-Linkou BranchTaoyuan City, Taiwan, 333|Sutton, Surrey, United Kingdom, Sm2 5Pt|London, United Kingdom, W12 0Hs|Los Angeles, California, United States, 90033 Lac+Usc Medical CenterLos Angeles, California, United States, 90033 Usc/Norris Comprehensive Cancer Center / Investigational Drug ServicesLos Angeles, California, United States, 90033 Usc/Norris Comprehensive Cancer CenterLos Angeles, California, United States, 90033 Rrmc - UclaLos Angeles, California, United States, 90095 Ucla Department Of MedicineLos Angeles, California, United States, 90095 Ucla Hematology/Oncology ClinicLos Angeles, California, United States, 90095 Ucla Ronald Reagan Medical CenterLos Angeles, California, United States, 90095 Keck Medicine Of Usc Norris Oncology/Hematology - Newport Beach Treatment CenterNewport Beach, California, United States, 92663 Usc Norris Oncology/Hematology - Newport BeachNewport Beach, California, United States, 92663 Uc Irvine Health - Chao Family Comprehensive Cancer CenterOrange, California, United States, 92868-3201 Uc Irvine Medical CenterOrange, California, United States, 92868-3201 Ucsf Helen Diller Family Comprehensive Cancer CenterSan Francisco, California, United States, 94143 University Of California, San Francisco Medical CenterSan Francisco, California, United States, 94143 University Of California, San FranciscoSan Francisco, California, United States, 94143|Kansas City, Missouri, United States, 64132|Lake Success, New York, United States, 11042 North Shore University HospitalManhasset, New York, United States, 11030 Long Island Jewish Medical CenterNew Hyde Park, New York, United States, 11040 University Of Rochester Cancer Center PharmacyRochester, New York, United States, 14642 University Of Rochester Medical CenterRochester, New York, United States, 14642|Cleveland, Ohio, United States, 44106 University Hospitals Cleveland Medical CenterCleveland, Ohio, United States, 44106 Cleveland Clinic FoundationCleveland, Ohio, United States, 44195|Nashville, Tennessee, United States, 37203|Dallas, Texas, United States, 75246 Baylor University Medical CenterDallas, Texas, United States, 75246 Blood Cancer And Stem Cell Transplant ClinicSan Antonio, Texas, United States, 78229 Methodist Healthcare System Of San AntonioSan Antonio, Texas, United States, 78229 Methodist Hospital Investigational PharmacySan Antonio, Texas, United States, 78229|Seattle, Washington, United States, 98104 Swedish Investigational Drug Services PharmacySeattle, Washington, United States, 98104 Swedish Medical CenterSeattle, Washington, United States, 98122","California|Missouri|New York|Ohio|Tennessee|Texas|Washington","Australia|Czechia|France|Hungary|Italy|Japan|Poland|Romania|Spain|Sweden|United Kingdom|United States","Australia, 5000 Royal Adelaide Hospital - Clinical Trials Pharmacy|Haematology And Bone Marrow Transplant Unit, Royal Adelaide Hospital|New South Wales St Vincent's Hospital Sydney|Interni Hematologicka A Onkologicka Klinika, Fakultni Nemocnice Brno|Chu Henri Mondor|Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Klinika, Hematologia Tanszek|An Aou Ospedali Riuniti Umberto I, G.M. Lancisi, G. Salesi, Clinica Di Ematologia|Fe A.O.U. Di Ferrara- Arcispedale Sant'Anna,|Aichi Japanese Red Cross Nagoya Daini Hospital|Akita University Hospital|Fukui University Of Fukui Hospital|Gunma Gunma University Hospital|Hyogo Kobe University Hospital|Kanagawa Yokohama City University Medical Center|Miyagi Tohoku University Hospital|Osaka Osaka City University Hospital|Shizuoka Shizuoka Cancer Center|Tokyo National Hospital Organization Disaster Medical Center|Klinika Hematologii I Transplantologii Uniwersyteckie Centrum Kliniczne|Dolj Spitalul Clinic Municipal Filantropia Craiova, Sectia Clinica Hematologie|Spitalul Clinic Coltea, Clinica De Hematologie|Hospital Del Mar|Apoex Vn|, Surrey The Royal Marsden Nhs Foundation Trust|Imperial College Healthcare Nhs Trust|Keck Hospital Of Usc|Midamerica Division, Inc., C/O Research Medical Center|Northwell Health/Monter Cancer Center|Taussig Cancer Center Investigational Pharmacy|The Sarah Cannon Research Institute|Baylor Scott And White Research Institute|Swedish Cancer Institute",{"$nulls":3},"Pfizer CT.gov Call Center","2019-01-07","2020-05-25T16:39:32.020","2020-05-26T17:10:42.972","NCT03416179"]
["5ecbf4c411702c1b1b916bc5","NCT03416179","2019-01-14","Pfizer","PFE","Recruiting","A Study Evaluating Intensive Chemotherapy With or Without Glasdegib or Azacitidine With or Without Glasdegib In Patients With Previously Untreated Acute Myeloid Leukemia (BRIGHT AML1019)","Glasdegib|Cytarabine|Daunorubicin|Azacitidine","Hh Inhibitor|DNA Polymerase Inhibitor|Nucleic Acid Synthesis Inhibitor|TOP2 Inhibitor|DNA Mtase Inhibitor","Unknown",null,"Unknown",null,"Phase 3",4,720,"Anticipated","2018-04-20","2021-06-13","OS","Overall Survival",{"$nulls":3},"Glasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).\n\nGlasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).","Two separate registration trials conducted under one protocol number are proposed to adequately and independently evaluate the addition of glasdegib in intensive and non-intensive chemotherapy populations. Each study will have an experimental treatment arm and a placebo arm. Endpoints are the same for each study except where specifically indicated.\n\nAssignment to the Intensive Study or the Non-Intensive Study will be made by the Investigator based on the 2017 European LeukemiaNet (ELN) recommendations.\n\nStudy B1371019 is a randomized (1:1), double-blind, multi-center, placebo controlled study of chemotherapy in combination with glasdegib versus chemotherapy in combination with placebo in adult patients with previously untreated AML.\n\nGlasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).\n\nGlasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).","A RANDOMIZED (1:1), DOUBLE-BLIND, MULTI-CENTER, PLACEBO CONTROLLED STUDY EVALUATING INTENSIVE CHEMOTHERAPY WITH OR WITHOUT GLASDEGIB (PF-04449913) OR AZACITIDINE (AZA) WITH OR WITHOUT GLASDEGIB IN PATIENTS WITH PREVIOUSLY UNTREATED ACUTE MYELOID LEUKEMIA","B1371019","Leukemia, Myeloid, Acute","Acute Leukemia|Acute Myeloid Leukemia|Myeloid Leukemia|Leukemia","Oncology Hematological","Oncology","Experimental|Placebo Comparator","Arm A (Intensive Study)|Arm B (Intensive Study)|Arm A (Non-intensive study)|Arm B (Non-intensive study)","Glasdegib + '7+3' Induction(s)|Placebo + '7+3' Induction(s)|Glasdegib + azacitidine|Placebo + azacitidine","Drug|Procedure","glasdegib|daunorubicin + cytarabine|cytarabine|HSCT|Placebo|azacitidine","Daily Glasdegib (100 mg, PO), beginning on Day 1 and is to continue up to 2 years post randomization.\n\nFollowing consolidation therapy, glasdegib or placebo will be administered daily for up to 2 years after randomization or until they have minimal residual disease (MRD) negative disease, whichever comes first.\n\nDaily Glasdegib (100 mg, PO) or matching placebo will continue throughout Induction(s) and Consolidation therapies regardless of dose modifications/delays in the chemotherapy.|Consolidation with single agent cytarabine 3 g/m2 IV for adults <60 years and 1 g/m2 for adults 60 years over 3 BID on Days 1, 3, and 5, every 28 days for up to 4 cycles or alternative single agent cytarabine consolidation schedules may be used per local prescribing information.|If required, and done per standard of care post Induction(s).|Azacitidine (75 mg/m2, SC or IV) daily for 7 days, in 28 day cycles for as long as they do not meet the criteria for disease progression, unacceptable toxicity, consent withdrawal, or death.|Matching placebo (PO) is to be administered by mouth daily beginning on Day 1 of chemotherapy and will continue if subjects demonstrate reasonable evidence of clinical benefit and do not meet the criteria for progression regardless of any delays/modifications in the chemotherapy treatment. Subjects will continue placebo until disease progression, unacceptable toxicity, consent withdrawal, or death, whichever comes first.","PF-04449913","Arm A (Intensive Study)|Arm B (Intensive Study)|Arm A (Non-intensive study)|Arm B (Non-intensive study)","\n\nSubjects must meet all of the following inclusion criteria to be eligible for enrollment into the Intensive and Non Intensive study (unless where indicated):\n\n 1.  Subjects with untreated AML according to the World Health Organization (WHO) 2016 Classification2, including those with: * AML arising from MDS or another antecedent hematologic disease (AHD).\n      * AML after previous cytotoxic therapy or radiation (secondary AML).\n     \n     \n 2.  18 years of age (In Japan, 20 years of age).\n 3.  Adequate Organ Function as defined by the following: * Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) 3 x upper limit of normal (ULN), excluding subjects with liver function abnormalities due to underlying malignancy.\n      * Total serum bilirubin 2 x ULN (except subjects with documented Gilbert's syndrome).\n      * Estimated creatinine clearance 30 mL/min as calculated using the standard method for the institution.\n     \n     \n 4.  QTc interval 470 msec using the Fridericia correction (QTcF).\n 5.  All anti cancer treatments (unless specified) should be discontinued 2 weeks from study entry, for example: targeted chemotherapy, radiotherapy, investigational agents, hormones, anagrelide or cytokines. * For control of rapidly progressing leukemia, all trans retinoic acid (ATRA), hydroxyurea, and/or leukopheresis may be used before and for up to 1 week after the first dose of glasdegib.\n     \n     \n 6.  Serum or urine pregnancy test (for female subjects of childbearing potential) with a minimum sensitivity of 25 IU/L or equivalent units of human chorionic gonadotropin (hCG) negative at screening.\n 7.  Male and female subjects of childbearing potential and at risk for pregnancy must agree to use at least one highly effective method of contraception throughout the study and for 180 days after the last dose of azacitidine, cytarabine, or daunorubicin; and the last dose of glasdegib or placebo, whichever occurs later.\n 8.  Female subjects of non childbearing potential must meet at least 1 of the following criteria: 1. Have undergone a documented hysterectomy and/or bilateral oophorectomy;\n      2. Have medically confirmed ovarian failure; or\n      3. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; status may be confirmed by having a serum follicle stimulating hormone (FSH) level confirming the postmenopausal state.\n     \n     All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential.\n     \n     \n 9.  Consent to a saliva sample collection for a germline comparator, unless prohibited by local regulations or ethics committee (EC) decision.\n 10. Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.\n 11. Subjects who are willing and able to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures (including bone marrow [BM] assessments).\n\n","\n\nSubjects with any of the following characteristics/conditions will not be included in the study:\n\n 1.  Acute Promyelocytic Leukemia (APL) and APLwith PML RARA, subjects (WHO 2016 classification).\n 2.  AML with BCR ABL1 or t(9;22)(q34;q11.2) as a sole abnormality. * Complex genetics may include t(9;22) cytogenetic translocation.\n     \n     \n 3.  Subjects with known active CNS leukemia.\n 4.  Participation in other clinical studies involving other investigational drug(s) (Phases 1 4) within 4 weeks prior study entry and/or during study participation.\n 5.  Subjects known to be refractory to platelet or packed red cell transfusions per Institutional Guidelines, or a patient who refuses blood product support.\n 6.  Subjects with another active malignancy on treatment with the exception of basal cell carcinoma, non melanoma skin cancer, cervical carcinoma in situ. Other prior or concurrent malignancies will be considered on a case by case basis.\n 7.  Any one of the following ongoing or in the previous 6 months: myocardial infarction, congenital long QT syndrome, Torsades de pointes, symptomatic arrhythmias (including sustained ventricular tachyarrhythmia), right or left bundle branch block and bifascicular block, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (CHF New York Heart Association class III or IV), cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism; as well as bradycardia defined as <50 bpms.\n 8.  Subjects with an active, life threatening or clinically significant uncontrolled systemic infection not related to AML.\n 9.  Subjects with left ventricular ejection fraction (LVEF) <50% are excluded from the Intensive Chemotherapy Study only.\n 10. Cumulative anthracycline dose equivalent of 550 mg/m2 of daunorubicin for the Intensive Chemotherapy Study only.\n 11. Known malabsorption syndrome or other condition that may significantly impair absorption of study medication in the investigator's judgment (eg, gastrectomy, lap band, Crohn's disease) and inability or unwillingness to swallow tablets or capsules.\n 12. Current use or anticipated requirement for drugs that are known strong CYP3A4/5 inducers.\n 13. Concurrent administration of herbal preparations.\n 14. Major surgery or radiation within 4 weeks of starting study treatment.\n 15. Documented or suspected hypersensitivity to any one of the following: * For subjects assigned to intensive chemotherapy, documented or suspected hypersensitivity to cytarabine (not including drug fever or exanthema, including known cerebellar side effects) or daunorubicin.\n      * For subjects assigned to non intensive chemotherapy, documented or suspected hypersensitivity to azacitidine or mannitol.\n     \n     \n 16. Known active drug or alcohol abuse.\n 17. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.\n 18. Pregnant females or breastfeeding female subjects.\n 19. Known recent or active suicidal ideation or behavior.\n 20. Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.","FSH",null,"Protein","Ovary","Actual","2018-01-31","Actual","Anticipated","2025-07-22","Anticipated","2019-01-01","2017-12-21","2018-01-23","2019-01-10","Yes","glasdegib;\nuntreated;\nHedgehog Inhibitor","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"All",null,"No","Yes\nPfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",null,"URL: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1371019&StudyName=A+Randomized+%281%3A1%29%2C+Double+Blind%2C+Multi+Center%2C+Placebo+Controlled+Study+Evaluating+Intensive+Chemotherapy+With+Or+Without+Glasdegib+%28pf+04449913%29+Or+Azacitidine+%28aza%29+With+Or+Without+Glasdegib+In+Patients+With+Previously+Untreated+Acute+Myeloid+Leukemia [https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1371019&StudyName=A+Randomized+%281%3A1%29%2C+Double+Blind%2C+Multi+Center%2C+Placebo+Controlled+Study+Evaluating+Intensive+Chemotherapy+With+Or+Without+Glasdegib+%28pf+04449913%29+Or+Azacitidine+%28aza%29+With+Or+Without+Glasdegib+In+Patients+With+Previously+Untreated+Acute+Myeloid+Leukemia] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To obtain contact information for a study center near you, click here.",null,"Yes","No",{"$nulls":17},"2017-002822-19|BRIGHT|BRIGHT AML1019","EudraCT Number|Alias Study Number","Overall survival","5 years after last subject randomized",null,"Fatigue score measured by the MD Anderson Symptom Inventory (MDASI)-AML/MDS questionnaire|Rate of Complete Remission (CR) (including CR with minimal residual disease (MRD)-negative as assessed by multiparametric flow cytometry)|Duration of response (defined as CR [includes CR-MRD negative]/CRi or CR/CRh as appropriate)|Time to response (CR[includes CR-MRD negative)]/CR with partial hematologic rcovery (CRh) as appropriate)|Event-free Survival|Patient Reported Outcomes (PROs) as measured by the M.D. Anderson Symptom Inventory AML/MDS Module (MDASI-AML/MDS)|Adverse events as graded by NCI CTCAE v4.03|Laboratory abnormalities as graded by NCI CTCAE v4.03|For the intensive study, the plasma trough concentration (Ctrough) will be analyzed|QTc interval|PROs as measured by Patient Global Impression of Change (PGIC)|Patient Reported Outcomes (PROs) as measured by EuroQoL 5 Dimension questionnaire 5-Level version (EQ-5D-5L)|Patient Reported Outcomes (PROs) as measured by Patient Global Impression of Symptoms (PGIS)|Complete Remission with incomplete hematologic recovery (CRi)|Rate of morphological leukemia-free state (MLFS)|Rate of Partial Remission (PR)|Rate of Complete Remission with partial hematological recovery (CRh) for the Non-intensive study only only|Minimum Observed Plasma Trough Concentratrion of glasdegib in the Intensive Study|Minimum Observed Plasma Trough Concentration of glasdegib in the Non-intensive study","Scale is from 0-10 where 0 is not present and 10 is as bad as you can image.|Response as defined by the 2017 European LeukemiaNet (ELN) recommendations.|5 years after last subject randomized, consent withdrawal, or death|Measurement Scale from 0-10.|PK samples taken on Induction(s) Day 1 (1 and 4 hours post induction); Induction(s) Day 10 (pre-dose, 1 and 4 hours post dose); Day 1 of each Consolidation cycle (pre-dose, 1 and 4 hours post dose)|One question asking for description of leukemia symptoms.|Series of questions that ask for information that best describes health.|One question asking for information regarding leukemia symptoms.|Its the minimum trough concentration in plasma of glasdegib following multiple daily dosing to steady state.|It is the minimum trough concentration in plasma of glasdegib following multiple daily dosing to steady state.","5 years after last subject randomized, consent withdrawal, or death|2 years after last dose of study therapy|5 years after last patient randomized, withdrawal, or death|5 years after last subject randomized, withdrawal, or death|Day 10 of Induction Cycle and Day 1 of each Consolidation Cycle|Cycle 1 Day 15 and Cycles 2 and 3 on Day 1","ClinicalTrials.gov_Inquiries@pfizer.com","Pfizer CT.gov Call Center","1-800-718-1021","Adelaide, South|Darlinghurst, New South Wales, Australia, 2010 St George HospitalKogarah, New South Wales, Australia, 2217|Salzburg, Austria, 5020 Uniklinikum Salzburg, Landeskrankenhaus Salzburg,Salzburg, Austria, 5020 Sozialmedizinisches Zentrum Sud.Wien, Austria, 1100 Krankenhaus Hietzing Mit Neurologischem Zentrum RosenhugelWien, Austria, I130|Brno, Czechia, 625 00 Nemocnicni LekarnaBrno, Czechia, 625 00 InternÃ­ HematologickÃ¡ Klinika, Fakultni Nemocnice KrÃ¡lovskÃ© VinohradyPraha 10, Czechia, 100 34 Ãšstavni LÃ©kÃ¡rnaPraha 10, Czechia, 100 34|Creteil, France, 94010 Chu Henri MondorCrÃ©teil, France, 94010 Chu De NantesNantes Cedex 1, France, 44093 Chu De Nantes Hotel DieuNantes Cedex, France, 44093 Hopital Saint LouisParis, France, 75010 Centre Hospitalier Lyon Sud -Unite De Pharmacie Clinique OncologiquePierre Benite Cedex, France, 69495 Centre Hospitalier Lyon Sud - Service D'HematologiePierre Benite Cedex, France, 69495|Debrecen, Hungary, 4032 Debreceni Egyetem Klinikai Kozpont Belgyogyaszati KlinikaDebrecen, Hungary, 4032|Ancona, An, Italy, 60126 Sod Farmacia-Dipt Dei Servizi -Aou Ospedali Riuniti Umberto I, G.M. Lancisi, G. SalesiTorette Di Ancona, An, Italy, 60126|Cona, Ferrara, Fe, Italy, 44124 Farmacia OspedalieraFerrara, Fe, Italy, 44121|Nagoya, Aichi, Japan, 466-8650|Akita, Japan, 010-8543 Kyushu University HospitalFukuoka, Japan, 812-8582 National Hospital Organization Kumamoto Medical Center[Active, Not Recruiting]Kumamoto, Japan, 860-0008 Nagasaki University HospitalNagasaki, Japan, 852-8501 Tokyo Medical University HospitalTokyo, Japan, 160-0023 Korea, Republic Of, Jeollabuk-Do Chonbuk National University HospitalJeonju-Si, Jeollabuk-Do, Korea, Republic Of, 54907 Korea, Republic Of, Jeollanam-Do Chonnam National University Hwasun HospitalHwasun-Gun, Jeollanam-Do, Korea, Republic Of, 58128 Korea, Republic Of Department Of Pharmacy, Inje University Busan Paik HospitalBusan, Korea, Republic Of, 47392 Inje University Busan Paik HospitalBusan, Korea, Republic Of, 47392 Clinical Trial Pharmacy, Keimyung University Dongsan HospitalDaegu, Korea, Republic Of, 41931 Keimyung University Dongsan HospitalDaegu, Korea, Republic Of, 41931 Gachon University Gil Medical CenterIncheon, Korea, Republic Of, 21565 Seoul National University HospitalSeoul, Korea, Republic Of, 03080 Severance Hospital, Yonsei University Health SystemSeoul, Korea, Republic Of, 03722 Department Of Pharmacy, Samsung Medical CenterSeoul, Korea, Republic Of, 06351 Samsung Medical CenterSeoul, Korea, Republic Of, 06351 The Catholic University Of Korea Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591 The Catholic University Of Korea, Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591|Yoshida-Gun, Fukui, Japan, 910-1193|Maebashi, Gunma, Japan, 371-8511|Kobe-Shi, Hyogo, Japan, 650-0017|Yokohama, Kanagawa, Japan, 232-0024|Sendai, Miyagi, Japan, 980-8574|Osaka-City, Osaka, Japan, 545-8586 Kindai University HospitalOsaka-Sayama, Osaka, Japan, 589-8511|Sunto-Gun, Shizuoka, Japan, 411-8777|Tachikawa, Tokyo, Japan, 190-0014|Gdansk, Poland, 80-952 Wwcoit Im. M. Kopernika W LodziLodz, Poland, 93-513|Craiova, Dolj, Romania, 200136|Bucuresti, Romania, 030171 Russian Federation Sbhi Cch No. 40 Hd MoscowMoscow, Russian Federation, 129301 State Budgetary Healthcare Institution Of MoscowMoscow, Russian Federation, 129301 Sbhi Nnr Nn Rch N. A. N.A. SemashkoNizhniy Novgorod, Russian Federation, 603126 State Budgetary Institution Of Ryazan Region 'Regional Clinical Hospital' (Sbi Rr Rch)Ryazan, Russian Federation, 390039 Fsbi Russrhti Fmba Of|Barcelona, Spain, 08003 Hospital De La Santa Creu I Sant PauBarcelona, Spain, 08025 Hospital Universitario Arnau De VilanovaLleida, Spain, 25198 Hospital General Universitario Gregorio MaranonMadrid, Spain, 28007 Hospital Universitario Ramon Y CajalMadrid, Spain, 28034 Hospital Universitario Virgen Del RocioSevilla, Spain, 41013 Hospital Universitari I Politecnic La FeValencia, Spain, 46026|Orebro, Sweden, 701 85 Universitetssjukhuset OrebroOrebro, Sweden, 701 85 Taiwan Department Of Clinical Trial Pharmacy, Taipei Veterans General HospitalTaipei, Taiwan, 11217 Taipei Veterans General HospitalTaipei, Taiwan, 11217 Division Of Pharmacy, Koo Foundation Sun Yat-Sen Cancer CenterTaipei, Taiwan, 112 Koo Foundation Sun Yat-Sen Cancer CenterTaipei, Taiwan, 112 Chang Gung Memorial Hospital-Linkou BranchTaoyuan City, Taiwan, 333 Chemotherapy Pharmacy, Chang Gung Memorial Hospital-Linkou BranchTaoyuan City, Taiwan, 333|Sutton, Surrey, United Kingdom, Sm2 5Pt|London, United Kingdom, W12 0Hs|Los Angeles, California, United States, 90033 Lac+Usc Medical CenterLos Angeles, California, United States, 90033 Usc/Norris Comprehensive Cancer Center / Investigational Drug ServicesLos Angeles, California, United States, 90033 Usc/Norris Comprehensive Cancer CenterLos Angeles, California, United States, 90033 Rrmc - UclaLos Angeles, California, United States, 90095 Ucla Department Of MedicineLos Angeles, California, United States, 90095 Ucla Hematology/Oncology ClinicLos Angeles, California, United States, 90095 Ucla Ronald Reagan Medical CenterLos Angeles, California, United States, 90095 Keck Medicine Of Usc Norris Oncology/Hematology - Newport Beach Treatment CenterNewport Beach, California, United States, 92663 Usc Norris Oncology/Hematology - Newport BeachNewport Beach, California, United States, 92663 Uc Irvine Health - Chao Family Comprehensive Cancer CenterOrange, California, United States, 92868-3201 Uc Irvine Medical CenterOrange, California, United States, 92868-3201 Ucsf Helen Diller Family Comprehensive Cancer CenterSan Francisco, California, United States, 94143 University Of California, San Francisco Medical CenterSan Francisco, California, United States, 94143 University Of California, San FranciscoSan Francisco, California, United States, 94143|Kansas City, Missouri, United States, 64132|Lake Success, New York, United States, 11042 North Shore University HospitalManhasset, New York, United States, 11030 Long Island Jewish Medical CenterNew Hyde Park, New York, United States, 11040 University Of Rochester Cancer Center PharmacyRochester, New York, United States, 14642 University Of Rochester Medical CenterRochester, New York, United States, 14642|Cleveland, Ohio, United States, 44106 University Hospitals Cleveland Medical CenterCleveland, Ohio, United States, 44106 Cleveland Clinic FoundationCleveland, Ohio, United States, 44195|Nashville, Tennessee, United States, 37203|Dallas, Texas, United States, 75246 Baylor University Medical CenterDallas, Texas, United States, 75246 Blood Cancer And Stem Cell Transplant ClinicSan Antonio, Texas, United States, 78229 Methodist Healthcare System Of San AntonioSan Antonio, Texas, United States, 78229 Methodist Hospital Investigational PharmacySan Antonio, Texas, United States, 78229|Seattle, Washington, United States, 98104 Swedish Investigational Drug Services PharmacySeattle, Washington, United States, 98104 Swedish Medical CenterSeattle, Washington, United States, 98122","California|Missouri|New York|Ohio|Tennessee|Texas|Washington","Australia|Austria|Czechia|France|Hungary|Italy|Japan|Poland|Romania|Spain|Sweden|United Kingdom|United States","Australia, 5000 Royal Adelaide Hospital - Clinical Trials Pharmacy|Haematology And Bone Marrow Transplant Unit, Royal Adelaide Hospital|New South Wales St Vincent's Hospital Sydney|Landeskrankenhaus Salzburg, Universitaetsklinik Fuer Innere Medizin Iii Der Pmu|Interni Hematologicka A Onkologicka Klinika, Fakultni Nemocnice Brno|Chu Henri Mondor|Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Klinika, Hematologia Tanszek|An Aou Ospedali Riuniti Umberto I, G.M. Lancisi, G. Salesi, Clinica Di Ematologia|Fe A.O.U. Di Ferrara- Arcispedale Sant'Anna,|Aichi Japanese Red Cross Nagoya Daini Hospital|Akita University Hospital|Fukui University Of Fukui Hospital|Gunma Gunma University Hospital|Hyogo Kobe University Hospital|Kanagawa Yokohama City University Medical Center|Miyagi Tohoku University Hospital|Osaka Osaka City University Hospital|Shizuoka Shizuoka Cancer Center|Tokyo National Hospital Organization Disaster Medical Center|Klinika Hematologii I Transplantologii Uniwersyteckie Centrum Kliniczne|Dolj Spitalul Clinic Municipal Filantropia Craiova, Sectia Clinica Hematologie|Spitalul Clinic Coltea, Clinica De Hematologie|Hospital Del Mar|Apoex Vn|, Surrey The Royal Marsden Nhs Foundation Trust|Imperial College Healthcare Nhs Trust|Keck Hospital Of Usc|Midamerica Division, Inc., C/O Research Medical Center|Northwell Health/Monter Cancer Center|Taussig Cancer Center Investigational Pharmacy|The Sarah Cannon Research Institute|Baylor Scott And White Research Institute|Swedish Cancer Institute",{"$nulls":3},"Pfizer CT.gov Call Center","2019-01-10","2020-05-25T16:39:32.634","2020-05-26T17:10:42.972","NCT03416179"]
["5ecbf4c4fe30261b1a0483b9","NCT03416179","2019-01-23","Pfizer","PFE","Recruiting","A Study Evaluating Intensive Chemotherapy With or Without Glasdegib or Azacitidine With or Without Glasdegib In Patients With Previously Untreated Acute Myeloid Leukemia (BRIGHT AML1019)","Glasdegib|Cytarabine|Daunorubicin|Azacitidine","Hh Inhibitor|DNA Polymerase Inhibitor|Nucleic Acid Synthesis Inhibitor|TOP2 Inhibitor|DNA Mtase Inhibitor","Unknown",null,"Unknown",null,"Phase 3",4,720,"Anticipated","2018-04-20","2021-06-13","OS","Overall Survival",{"$nulls":3},"Glasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).\n\nGlasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).","Two separate registration trials conducted under one protocol number are proposed to adequately and independently evaluate the addition of glasdegib in intensive and non-intensive chemotherapy populations. Each study will have an experimental treatment arm and a placebo arm. Endpoints are the same for each study except where specifically indicated.\n\nAssignment to the Intensive Study or the Non-Intensive Study will be made by the Investigator based on the 2017 European LeukemiaNet (ELN) recommendations.\n\nStudy B1371019 is a randomized (1:1), double-blind, multi-center, placebo controlled study of chemotherapy in combination with glasdegib versus chemotherapy in combination with placebo in adult patients with previously untreated AML.\n\nGlasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).\n\nGlasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).","A RANDOMIZED (1:1), DOUBLE-BLIND, MULTI-CENTER, PLACEBO CONTROLLED STUDY EVALUATING INTENSIVE CHEMOTHERAPY WITH OR WITHOUT GLASDEGIB (PF-04449913) OR AZACITIDINE (AZA) WITH OR WITHOUT GLASDEGIB IN PATIENTS WITH PREVIOUSLY UNTREATED ACUTE MYELOID LEUKEMIA","B1371019","Leukemia, Myeloid, Acute","Acute Leukemia|Acute Myeloid Leukemia|Myeloid Leukemia|Leukemia","Oncology Hematological","Oncology","Experimental|Placebo Comparator","Arm A (Intensive Study)|Arm B (Intensive Study)|Arm A (Non-intensive study)|Arm B (Non-intensive study)","Glasdegib + '7+3' Induction(s)|Placebo + '7+3' Induction(s)|Glasdegib + azacitidine|Placebo + azacitidine","Drug|Procedure","glasdegib|daunorubicin + cytarabine|cytarabine|HSCT|Placebo|azacitidine","Daily Glasdegib (100 mg, PO), beginning on Day 1 and is to continue up to 2 years post randomization.\n\nFollowing consolidation therapy, glasdegib or placebo will be administered daily for up to 2 years after randomization or until they have minimal residual disease (MRD) negative disease, whichever comes first.\n\nDaily Glasdegib (100 mg, PO) or matching placebo will continue throughout Induction(s) and Consolidation therapies regardless of dose modifications/delays in the chemotherapy.|Consolidation with single agent cytarabine 3 g/m2 IV for adults <60 years and 1 g/m2 for adults 60 years over 3 BID on Days 1, 3, and 5, every 28 days for up to 4 cycles or alternative single agent cytarabine consolidation schedules may be used per local prescribing information.|If required, and done per standard of care post Induction(s).|Azacitidine (75 mg/m2, SC or IV) daily for 7 days, in 28 day cycles for as long as they do not meet the criteria for disease progression, unacceptable toxicity, consent withdrawal, or death.|Matching placebo (PO) is to be administered by mouth daily beginning on Day 1 of chemotherapy and will continue if subjects demonstrate reasonable evidence of clinical benefit and do not meet the criteria for progression regardless of any delays/modifications in the chemotherapy treatment. Subjects will continue placebo until disease progression, unacceptable toxicity, consent withdrawal, or death, whichever comes first.","PF-04449913","Arm A (Intensive Study)|Arm B (Intensive Study)|Arm A (Non-intensive study)|Arm B (Non-intensive study)","\n\nSubjects must meet all of the following inclusion criteria to be eligible for enrollment into the Intensive and Non Intensive study (unless where indicated):\n\n 1.  Subjects with untreated AML according to the World Health Organization (WHO) 2016 Classification2, including those with: * AML arising from MDS or another antecedent hematologic disease (AHD).\n      * AML after previous cytotoxic therapy or radiation (secondary AML).\n     \n     \n 2.  18 years of age (In Japan, 20 years of age).\n 3.  Adequate Organ Function as defined by the following: * Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) 3 x upper limit of normal (ULN), excluding subjects with liver function abnormalities due to underlying malignancy.\n      * Total serum bilirubin 2 x ULN (except subjects with documented Gilbert's syndrome).\n      * Estimated creatinine clearance 30 mL/min as calculated using the standard method for the institution.\n     \n     \n 4.  QTc interval 470 msec using the Fridericia correction (QTcF).\n 5.  All anti cancer treatments (unless specified) should be discontinued 2 weeks from study entry, for example: targeted chemotherapy, radiotherapy, investigational agents, hormones, anagrelide or cytokines. * For control of rapidly progressing leukemia, all trans retinoic acid (ATRA), hydroxyurea, and/or leukopheresis may be used before and for up to 1 week after the first dose of glasdegib.\n     \n     \n 6.  Serum or urine pregnancy test (for female subjects of childbearing potential) with a minimum sensitivity of 25 IU/L or equivalent units of human chorionic gonadotropin (hCG) negative at screening.\n 7.  Male and female subjects of childbearing potential and at risk for pregnancy must agree to use at least one highly effective method of contraception throughout the study and for 180 days after the last dose of azacitidine, cytarabine, or daunorubicin; and the last dose of glasdegib or placebo, whichever occurs later.\n 8.  Female subjects of non childbearing potential must meet at least 1 of the following criteria: 1. Have undergone a documented hysterectomy and/or bilateral oophorectomy;\n      2. Have medically confirmed ovarian failure; or\n      3. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; status may be confirmed by having a serum follicle stimulating hormone (FSH) level confirming the postmenopausal state.\n     \n     All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential.\n     \n     \n 9.  Consent to a saliva sample collection for a germline comparator, unless prohibited by local regulations or ethics committee (EC) decision.\n 10. Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.\n 11. Subjects who are willing and able to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures (including bone marrow [BM] assessments).\n\n","\n\nSubjects with any of the following characteristics/conditions will not be included in the study:\n\n 1.  Acute Promyelocytic Leukemia (APL) and APLwith PML RARA, subjects (WHO 2016 classification).\n 2.  AML with BCR ABL1 or t(9;22)(q34;q11.2) as a sole abnormality. * Complex genetics may include t(9;22) cytogenetic translocation.\n     \n     \n 3.  Subjects with known active CNS leukemia.\n 4.  Participation in other clinical studies involving other investigational drug(s) (Phases 1 4) within 4 weeks prior study entry and/or during study participation.\n 5.  Subjects known to be refractory to platelet or packed red cell transfusions per Institutional Guidelines, or a patient who refuses blood product support.\n 6.  Subjects with another active malignancy on treatment with the exception of basal cell carcinoma, non melanoma skin cancer, cervical carcinoma in situ. Other prior or concurrent malignancies will be considered on a case by case basis.\n 7.  Any one of the following ongoing or in the previous 6 months: myocardial infarction, congenital long QT syndrome, Torsades de pointes, symptomatic arrhythmias (including sustained ventricular tachyarrhythmia), right or left bundle branch block and bifascicular block, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (CHF New York Heart Association class III or IV), cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism; as well as bradycardia defined as <50 bpms.\n 8.  Subjects with an active, life threatening or clinically significant uncontrolled systemic infection not related to AML.\n 9.  Subjects with left ventricular ejection fraction (LVEF) <50% are excluded from the Intensive Chemotherapy Study only.\n 10. Cumulative anthracycline dose equivalent of 550 mg/m2 of daunorubicin for the Intensive Chemotherapy Study only.\n 11. Known malabsorption syndrome or other condition that may significantly impair absorption of study medication in the investigator's judgment (eg, gastrectomy, lap band, Crohn's disease) and inability or unwillingness to swallow tablets or capsules.\n 12. Current use or anticipated requirement for drugs that are known strong CYP3A4/5 inducers.\n 13. Concurrent administration of herbal preparations.\n 14. Major surgery or radiation within 4 weeks of starting study treatment.\n 15. Documented or suspected hypersensitivity to any one of the following: * For subjects assigned to intensive chemotherapy, documented or suspected hypersensitivity to cytarabine (not including drug fever or exanthema, including known cerebellar side effects) or daunorubicin.\n      * For subjects assigned to non intensive chemotherapy, documented or suspected hypersensitivity to azacitidine or mannitol.\n     \n     \n 16. Known active drug or alcohol abuse.\n 17. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.\n 18. Pregnant females or breastfeeding female subjects.\n 19. Known recent or active suicidal ideation or behavior.\n 20. Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.","FSH",null,"Protein","Ovary","Actual","2018-01-31","Actual","Anticipated","2025-07-22","Anticipated","2019-01-01","2017-12-21","2018-01-23","2019-01-19","Yes","glasdegib;\nuntreated;\nHedgehog Inhibitor","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"All",null,"No","Yes\nPfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",null,"URL: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1371019&StudyName=A+Randomized+%281%3A1%29%2C+Double+Blind%2C+Multi+Center%2C+Placebo+Controlled+Study+Evaluating+Intensive+Chemotherapy+With+Or+Without+Glasdegib+%28pf+04449913%29+Or+Azacitidine+%28aza%29+With+Or+Without+Glasdegib+In+Patients+With+Previously+Untreated+Acute+Myeloid+Leukemia [https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1371019&StudyName=A+Randomized+%281%3A1%29%2C+Double+Blind%2C+Multi+Center%2C+Placebo+Controlled+Study+Evaluating+Intensive+Chemotherapy+With+Or+Without+Glasdegib+%28pf+04449913%29+Or+Azacitidine+%28aza%29+With+Or+Without+Glasdegib+In+Patients+With+Previously+Untreated+Acute+Myeloid+Leukemia] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To obtain contact information for a study center near you, click here.",null,"Yes","No",{"$nulls":17},"2017-002822-19|BRIGHT|BRIGHT AML1019","EudraCT Number|Alias Study Number","Overall survival","5 years after last subject randomized",null,"Fatigue score measured by the MD Anderson Symptom Inventory (MDASI)-AML/MDS questionnaire|Rate of Complete Remission (CR) (including CR with minimal residual disease (MRD)-negative as assessed by multiparametric flow cytometry)|Duration of response (defined as CR [includes CR-MRD negative]/CRi or CR/CRh as appropriate)|Time to response (CR[includes CR-MRD negative)]/CR with partial hematologic rcovery (CRh) as appropriate)|Event-free Survival|Patient Reported Outcomes (PROs) as measured by the M.D. Anderson Symptom Inventory AML/MDS Module (MDASI-AML/MDS)|Adverse events as graded by NCI CTCAE v4.03|Laboratory abnormalities as graded by NCI CTCAE v4.03|For the intensive study, the plasma trough concentration (Ctrough) will be analyzed|QTc interval|PROs as measured by Patient Global Impression of Change (PGIC)|Patient Reported Outcomes (PROs) as measured by EuroQoL 5 Dimension questionnaire 5-Level version (EQ-5D-5L)|Patient Reported Outcomes (PROs) as measured by Patient Global Impression of Symptoms (PGIS)|Complete Remission with incomplete hematologic recovery (CRi)|Rate of morphological leukemia-free state (MLFS)|Rate of Partial Remission (PR)|Rate of Complete Remission with partial hematological recovery (CRh) for the Non-intensive study only only|Minimum Observed Plasma Trough Concentratrion of glasdegib in the Intensive Study|Minimum Observed Plasma Trough Concentration of glasdegib in the Non-intensive study","Scale is from 0-10 where 0 is not present and 10 is as bad as you can image.|Response as defined by the 2017 European LeukemiaNet (ELN) recommendations.|5 years after last subject randomized, consent withdrawal, or death|Measurement Scale from 0-10.|PK samples taken on Induction(s) Day 1 (1 and 4 hours post induction); Induction(s) Day 10 (pre-dose, 1 and 4 hours post dose); Day 1 of each Consolidation cycle (pre-dose, 1 and 4 hours post dose)|One question asking for description of leukemia symptoms.|Series of questions that ask for information that best describes health.|One question asking for information regarding leukemia symptoms.|Its the minimum trough concentration in plasma of glasdegib following multiple daily dosing to steady state.|It is the minimum trough concentration in plasma of glasdegib following multiple daily dosing to steady state.","5 years after last subject randomized, consent withdrawal, or death|2 years after last dose of study therapy|5 years after last patient randomized, withdrawal, or death|5 years after last subject randomized, withdrawal, or death|Day 10 of Induction Cycle and Day 1 of each Consolidation Cycle|Cycle 1 Day 15 and Cycles 2 and 3 on Day 1","ClinicalTrials.gov_Inquiries@pfizer.com","Pfizer CT.gov Call Center","1-800-718-1021","Adelaide, South|Darlinghurst, New South Wales, Australia, 2010 St George HospitalKogarah, New South Wales, Australia, 2217|Salzburg, Austria, 5020 Uniklinikum Salzburg, Landeskrankenhaus Salzburg,Salzburg, Austria, 5020 Sozialmedizinisches Zentrum Sud.Wien, Austria, 1100 Krankenhaus Hietzing Mit Neurologischem Zentrum RosenhugelWien, Austria, I130|Winnipeg, Manitoba, Canada, R3E 0V9|Brno, Czechia, 625 00 Nemocnicni LekarnaBrno, Czechia, 625 00 InternÃ­ HematologickÃ¡ Klinika, Fakultni Nemocnice KrÃ¡lovskÃ© VinohradyPraha 10, Czechia, 100 34 Ãšstavni LÃ©kÃ¡rnaPraha 10, Czechia, 100 34|Creteil, France, 94010 Chu Henri MondorCrÃ©teil, France, 94010 Chu De NantesNantes Cedex 1, France, 44093 Chu De Nantes Hotel DieuNantes Cedex, France, 44093 Hopital Saint LouisParis, France, 75010 Centre Hospitalier Lyon Sud -Unite De Pharmacie Clinique OncologiquePierre Benite Cedex, France, 69495 Centre Hospitalier Lyon Sud - Service D'HematologiePierre Benite Cedex, France, 69495|Debrecen, Hungary, 4032 Debreceni Egyetem Klinikai Kozpont Belgyogyaszati KlinikaDebrecen, Hungary, 4032|Ancona, An, Italy, 60126 Sod Farmacia-Dipt Dei Servizi -Aou Ospedali Riuniti Umberto I, G.M. Lancisi, G. SalesiTorette Di Ancona, An, Italy, 60126|Cona, Ferrara, Fe, Italy, 44124 Farmacia OspedalieraFerrara, Fe, Italy, 44121|Nagoya, Aichi, Japan, 466-8650|Akita, Japan, 010-8543 Kyushu University HospitalFukuoka, Japan, 812-8582 National Hospital Organization Kumamoto Medical Center[Active, Not Recruiting]Kumamoto, Japan, 860-0008 Nagasaki University HospitalNagasaki, Japan, 852-8501 Tokyo Medical University HospitalTokyo, Japan, 160-0023 Korea, Republic Of, Jeollabuk-Do Chonbuk National University HospitalJeonju-Si, Jeollabuk-Do, Korea, Republic Of, 54907 Korea, Republic Of, Jeollanam-Do Chonnam National University Hwasun HospitalHwasun-Gun, Jeollanam-Do, Korea, Republic Of, 58128 Korea, Republic Of Department Of Pharmacy, Inje University Busan Paik HospitalBusan, Korea, Republic Of, 47392 Inje University Busan Paik HospitalBusan, Korea, Republic Of, 47392 Clinical Trial Pharmacy, Keimyung University Dongsan HospitalDaegu, Korea, Republic Of, 41931 Keimyung University Dongsan HospitalDaegu, Korea, Republic Of, 41931 Gachon University Gil Medical CenterIncheon, Korea, Republic Of, 21565 Seoul National University HospitalSeoul, Korea, Republic Of, 03080 Severance Hospital, Yonsei University Health SystemSeoul, Korea, Republic Of, 03722 Department Of Pharmacy, Samsung Medical CenterSeoul, Korea, Republic Of, 06351 Samsung Medical CenterSeoul, Korea, Republic Of, 06351 The Catholic University Of Korea Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591 The Catholic University Of Korea, Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591|Yoshida-Gun, Fukui, Japan, 910-1193|Maebashi, Gunma, Japan, 371-8511|Kobe-Shi, Hyogo, Japan, 650-0017|Yokohama, Kanagawa, Japan, 232-0024|Sendai, Miyagi, Japan, 980-8574|Osaka-City, Osaka, Japan, 545-8586 Kindai University HospitalOsaka-Sayama, Osaka, Japan, 589-8511|Sunto-Gun, Shizuoka, Japan, 411-8777|Tachikawa, Tokyo, Japan, 190-0014|Gdansk, Poland, 80-952 Wwcoit Im. M. Kopernika W LodziLodz, Poland, 93-513|Craiova, Dolj, Romania, 200136|Bucuresti, Romania, 030171 Russian Federation Sbhi Cch No. 40 Hd MoscowMoscow, Russian Federation, 129301 State Budgetary Healthcare Institution Of MoscowMoscow, Russian Federation, 129301 Sbhi Nnr Nn Rch N. A. N.A. SemashkoNizhniy Novgorod, Russian Federation, 603126 State Budgetary Institution Of Ryazan Region 'Regional Clinical Hospital' (Sbi Rr Rch)Ryazan, Russian Federation, 390039 Fsbi Russrhti Fmba Of|Barcelona, Spain, 08003 Hospital De La Santa Creu I Sant PauBarcelona, Spain, 08025 Hospital Universitario Arnau De VilanovaLleida, Spain, 25198 Hospital General Universitario Gregorio MaranonMadrid, Spain, 28007 Hospital Universitario Ramon Y CajalMadrid, Spain, 28034 Hospital Universitario Virgen Del RocioSevilla, Spain, 41013 Hospital Universitari I Politecnic La FeValencia, Spain, 46026|Orebro, Sweden, 701 85 Universitetssjukhuset OrebroOrebro, Sweden, 701 85 Taiwan Department Of Clinical Trial Pharmacy, Taipei Veterans General HospitalTaipei, Taiwan, 11217 Taipei Veterans General HospitalTaipei, Taiwan, 11217 Division Of Pharmacy, Koo Foundation Sun Yat-Sen Cancer CenterTaipei, Taiwan, 112 Koo Foundation Sun Yat-Sen Cancer CenterTaipei, Taiwan, 112 Chang Gung Memorial Hospital-Linkou BranchTaoyuan City, Taiwan, 333 Chemotherapy Pharmacy, Chang Gung Memorial Hospital-Linkou BranchTaoyuan City, Taiwan, 333|Sutton, Surrey, United Kingdom, Sm2 5Pt|London, United Kingdom, W12 0Hs|Los Angeles, California, United States, 90033 Lac+Usc Medical CenterLos Angeles, California, United States, 90033 Usc/Norris Comprehensive Cancer Center / Investigational Drug ServicesLos Angeles, California, United States, 90033 Usc/Norris Comprehensive Cancer CenterLos Angeles, California, United States, 90033 Rrmc - UclaLos Angeles, California, United States, 90095 Ucla Department Of MedicineLos Angeles, California, United States, 90095 Ucla Hematology/Oncology ClinicLos Angeles, California, United States, 90095 Ucla Ronald Reagan Medical CenterLos Angeles, California, United States, 90095 Keck Medicine Of Usc Norris Oncology/Hematology - Newport Beach Treatment CenterNewport Beach, California, United States, 92663 Usc Norris Oncology/Hematology - Newport BeachNewport Beach, California, United States, 92663 Uc Irvine Health - Chao Family Comprehensive Cancer CenterOrange, California, United States, 92868-3201 Uc Irvine Medical CenterOrange, California, United States, 92868-3201 Ucsf Helen Diller Family Comprehensive Cancer CenterSan Francisco, California, United States, 94143 University Of California, San Francisco Medical CenterSan Francisco, California, United States, 94143 University Of California, San FranciscoSan Francisco, California, United States, 94143|Kansas City, Missouri, United States, 64132|Lake Success, New York, United States, 11042 North Shore University HospitalManhasset, New York, United States, 11030 Long Island Jewish Medical CenterNew Hyde Park, New York, United States, 11040 University Of Rochester Cancer Center PharmacyRochester, New York, United States, 14642 University Of Rochester Medical CenterRochester, New York, United States, 14642|Cleveland, Ohio, United States, 44106 University Hospitals Cleveland Medical CenterCleveland, Ohio, United States, 44106 Cleveland Clinic FoundationCleveland, Ohio, United States, 44195|Nashville, Tennessee, United States, 37203|Dallas, Texas, United States, 75246 Baylor University Medical CenterDallas, Texas, United States, 75246 Blood Cancer And Stem Cell Transplant ClinicSan Antonio, Texas, United States, 78229 Methodist Healthcare System Of San AntonioSan Antonio, Texas, United States, 78229 Methodist Hospital Investigational PharmacySan Antonio, Texas, United States, 78229|Seattle, Washington, United States, 98104 Swedish Investigational Drug Services PharmacySeattle, Washington, United States, 98104 Swedish Medical CenterSeattle, Washington, United States, 98122","California|Missouri|New York|Ohio|Tennessee|Texas|Washington","Australia|Austria|Canada|Czechia|France|Hungary|Italy|Japan|Poland|Romania|Spain|Sweden|United Kingdom|United States","Australia, 5000 Royal Adelaide Hospital|New South Wales St Vincent's Hospital Sydney|Royal Adelaide Hospital - Clinical Trials Pharmacy|Landeskrankenhaus Salzburg, Universitaetsklinik Fuer Innere Medizin Iii Der Pmu|Manitoba Cancercare Manitoba|Interni Hematologicka A Onkologicka Klinika, Fakultni Nemocnice Brno|Chu Henri Mondor|Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Klinika, Hematologia Tanszek|An Aou Ospedali Riuniti Umberto I, G.M. Lancisi, G. Salesi, Clinica Di Ematologia|Fe A.O.U. Di Ferrara- Arcispedale Sant'Anna,|Aichi Japanese Red Cross Nagoya Daini Hospital|Akita University Hospital|Fukui University Of Fukui Hospital|Gunma Gunma University Hospital|Hyogo Kobe University Hospital|Kanagawa Yokohama City University Medical Center|Miyagi Tohoku University Hospital|Osaka Osaka City University Hospital|Shizuoka Shizuoka Cancer Center|Tokyo National Hospital Organization Disaster Medical Center|Klinika Hematologii I Transplantologii Uniwersyteckie Centrum Kliniczne|Dolj Spitalul Clinic Municipal Filantropia Craiova, Sectia Clinica Hematologie|Spitalul Clinic Coltea, Clinica De Hematologie|Hospital Del Mar|Apoex Vn|, Surrey The Royal Marsden Nhs Foundation Trust|Imperial College Healthcare Nhs Trust|Keck Hospital Of Usc|Midamerica Division, Inc., C/O Research Medical Center|Northwell Health/Monter Cancer Center|Taussig Cancer Center Investigational Pharmacy|The Sarah Cannon Research Institute|Baylor Scott And White Research Institute|Swedish Cancer Institute",{"$nulls":3},"Pfizer CT.gov Call Center","2019-01-19","2020-05-25T16:39:32.631","2020-05-26T17:10:42.972","NCT03416179"]
["5ecbf4c511702c1b1b916bc6","NCT03416179","2019-02-01","Pfizer","PFE","Recruiting","A Study Evaluating Intensive Chemotherapy With or Without Glasdegib or Azacitidine With or Without Glasdegib In Patients With Previously Untreated Acute Myeloid Leukemia (BRIGHT AML1019)","Glasdegib|Cytarabine|Daunorubicin|Azacitidine","Hh Inhibitor|DNA Polymerase Inhibitor|Nucleic Acid Synthesis Inhibitor|TOP2 Inhibitor|DNA Mtase Inhibitor","Unknown",null,"Unknown",null,"Phase 3",4,720,"Anticipated","2018-04-20","2021-06-13","OS","Overall Survival",{"$nulls":3},"Glasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).\n\nGlasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).","Two separate registration trials conducted under one protocol number are proposed to adequately and independently evaluate the addition of glasdegib in intensive and non-intensive chemotherapy populations. Each study will have an experimental treatment arm and a placebo arm. Endpoints are the same for each study except where specifically indicated.\n\nAssignment to the Intensive Study or the Non-Intensive Study will be made by the Investigator based on the 2017 European LeukemiaNet (ELN) recommendations.\n\nStudy B1371019 is a randomized (1:1), double-blind, multi-center, placebo controlled study of chemotherapy in combination with glasdegib versus chemotherapy in combination with placebo in adult patients with previously untreated AML.\n\nGlasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).\n\nGlasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).","A RANDOMIZED (1:1), DOUBLE-BLIND, MULTI-CENTER, PLACEBO CONTROLLED STUDY EVALUATING INTENSIVE CHEMOTHERAPY WITH OR WITHOUT GLASDEGIB (PF-04449913) OR AZACITIDINE (AZA) WITH OR WITHOUT GLASDEGIB IN PATIENTS WITH PREVIOUSLY UNTREATED ACUTE MYELOID LEUKEMIA","B1371019","Leukemia, Myeloid, Acute","Acute Leukemia|Acute Myeloid Leukemia|Myeloid Leukemia|Leukemia","Oncology Hematological","Oncology","Experimental|Placebo Comparator","Arm A (Intensive Study)|Arm B (Intensive Study)|Arm A (Non-intensive study)|Arm B (Non-intensive study)","Glasdegib + '7+3' Induction(s)|Placebo + '7+3' Induction(s)|Glasdegib + azacitidine|Placebo + azacitidine","Drug|Procedure","glasdegib|daunorubicin + cytarabine|cytarabine|HSCT|Placebo|azacitidine","Daily Glasdegib (100 mg, PO), beginning on Day 1 and is to continue up to 2 years post randomization.\n\nFollowing consolidation therapy, glasdegib or placebo will be administered daily for up to 2 years after randomization or until they have minimal residual disease (MRD) negative disease, whichever comes first.\n\nDaily Glasdegib (100 mg, PO) or matching placebo will continue throughout Induction(s) and Consolidation therapies regardless of dose modifications/delays in the chemotherapy.|Consolidation with single agent cytarabine 3 g/m2 IV for adults <60 years and 1 g/m2 for adults 60 years over 3 BID on Days 1, 3, and 5, every 28 days for up to 4 cycles or alternative single agent cytarabine consolidation schedules may be used per local prescribing information.|If required, and done per standard of care post Induction(s).|Azacitidine (75 mg/m2, SC or IV) daily for 7 days, in 28 day cycles for as long as they do not meet the criteria for disease progression, unacceptable toxicity, consent withdrawal, or death.|Matching placebo (PO) is to be administered by mouth daily beginning on Day 1 of chemotherapy and will continue if subjects demonstrate reasonable evidence of clinical benefit and do not meet the criteria for progression regardless of any delays/modifications in the chemotherapy treatment. Subjects will continue placebo until disease progression, unacceptable toxicity, consent withdrawal, or death, whichever comes first.","PF-04449913","Arm A (Intensive Study)|Arm B (Intensive Study)|Arm A (Non-intensive study)|Arm B (Non-intensive study)","\n\nSubjects must meet all of the following inclusion criteria to be eligible for enrollment into the Intensive and Non Intensive study (unless where indicated):\n\n 1.  Subjects with untreated AML according to the World Health Organization (WHO) 2016 Classification2, including those with: * AML arising from MDS or another antecedent hematologic disease (AHD).\n      * AML after previous cytotoxic therapy or radiation (secondary AML).\n     \n     \n 2.  18 years of age (In Japan, 20 years of age).\n 3.  Adequate Organ Function as defined by the following: * Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) 3 x upper limit of normal (ULN), excluding subjects with liver function abnormalities due to underlying malignancy.\n      * Total serum bilirubin 2 x ULN (except subjects with documented Gilbert's syndrome).\n      * Estimated creatinine clearance 30 mL/min as calculated using the standard method for the institution.\n     \n     \n 4.  QTc interval 470 msec using the Fridericia correction (QTcF).\n 5.  All anti cancer treatments (unless specified) should be discontinued 2 weeks from study entry, for example: targeted chemotherapy, radiotherapy, investigational agents, hormones, anagrelide or cytokines. * For control of rapidly progressing leukemia, all trans retinoic acid (ATRA), hydroxyurea, and/or leukopheresis may be used before and for up to 1 week after the first dose of glasdegib.\n     \n     \n 6.  Serum or urine pregnancy test (for female subjects of childbearing potential) with a minimum sensitivity of 25 IU/L or equivalent units of human chorionic gonadotropin (hCG) negative at screening.\n 7.  Male and female subjects of childbearing potential and at risk for pregnancy must agree to use at least one highly effective method of contraception throughout the study and for 180 days after the last dose of azacitidine, cytarabine, or daunorubicin; and the last dose of glasdegib or placebo, whichever occurs later.\n 8.  Female subjects of non childbearing potential must meet at least 1 of the following criteria: 1. Have undergone a documented hysterectomy and/or bilateral oophorectomy;\n      2. Have medically confirmed ovarian failure; or\n      3. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; status may be confirmed by having a serum follicle stimulating hormone (FSH) level confirming the postmenopausal state.\n     \n     All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential.\n     \n     \n 9.  Consent to a saliva sample collection for a germline comparator, unless prohibited by local regulations or ethics committee (EC) decision.\n 10. Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.\n 11. Subjects who are willing and able to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures (including bone marrow [BM] assessments).\n\n","\n\nSubjects with any of the following characteristics/conditions will not be included in the study:\n\n 1.  Acute Promyelocytic Leukemia (APL) and APLwith PML RARA, subjects (WHO 2016 classification).\n 2.  AML with BCR ABL1 or t(9;22)(q34;q11.2) as a sole abnormality. * Complex genetics may include t(9;22) cytogenetic translocation.\n     \n     \n 3.  Subjects with known active CNS leukemia.\n 4.  Participation in other clinical studies involving other investigational drug(s) (Phases 1 4) within 4 weeks prior study entry and/or during study participation.\n 5.  Subjects known to be refractory to platelet or packed red cell transfusions per Institutional Guidelines, or a patient who refuses blood product support.\n 6.  Subjects with another active malignancy on treatment with the exception of basal cell carcinoma, non melanoma skin cancer, cervical carcinoma in situ. Other prior or concurrent malignancies will be considered on a case by case basis.\n 7.  Any one of the following ongoing or in the previous 6 months: myocardial infarction, congenital long QT syndrome, Torsades de pointes, symptomatic arrhythmias (including sustained ventricular tachyarrhythmia), right or left bundle branch block and bifascicular block, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (CHF New York Heart Association class III or IV), cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism; as well as bradycardia defined as <50 bpms.\n 8.  Subjects with an active, life threatening or clinically significant uncontrolled systemic infection not related to AML.\n 9.  Subjects with left ventricular ejection fraction (LVEF) <50% are excluded from the Intensive Chemotherapy Study only.\n 10. Cumulative anthracycline dose equivalent of 550 mg/m2 of daunorubicin for the Intensive Chemotherapy Study only.\n 11. Known malabsorption syndrome or other condition that may significantly impair absorption of study medication in the investigator's judgment (eg, gastrectomy, lap band, Crohn's disease) and inability or unwillingness to swallow tablets or capsules.\n 12. Current use or anticipated requirement for drugs that are known strong CYP3A4/5 inducers.\n 13. Concurrent administration of herbal preparations.\n 14. Major surgery or radiation within 4 weeks of starting study treatment.\n 15. Documented or suspected hypersensitivity to any one of the following: * For subjects assigned to intensive chemotherapy, documented or suspected hypersensitivity to cytarabine (not including drug fever or exanthema, including known cerebellar side effects) or daunorubicin.\n      * For subjects assigned to non intensive chemotherapy, documented or suspected hypersensitivity to azacitidine or mannitol.\n     \n     \n 16. Known active drug or alcohol abuse.\n 17. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.\n 18. Pregnant females or breastfeeding female subjects.\n 19. Known recent or active suicidal ideation or behavior.\n 20. Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.","FSH",null,"Protein","Ovary","Actual","2018-01-31","Actual","Anticipated","2025-07-22","Anticipated","2019-01-01","2017-12-21","2018-01-23","2019-01-31","Yes","glasdegib;\nuntreated;\nHedgehog Inhibitor","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"All",null,"No","Yes\nPfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",null,"URL: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1371019&StudyName=A+Randomized+%281%3A1%29%2C+Double+Blind%2C+Multi+Center%2C+Placebo+Controlled+Study+Evaluating+Intensive+Chemotherapy+With+Or+Without+Glasdegib+%28pf+04449913%29+Or+Azacitidine+%28aza%29+With+Or+Without+Glasdegib+In+Patients+With+Previously+Untreated+Acute+Myeloid+Leukemia [https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1371019&StudyName=A+Randomized+%281%3A1%29%2C+Double+Blind%2C+Multi+Center%2C+Placebo+Controlled+Study+Evaluating+Intensive+Chemotherapy+With+Or+Without+Glasdegib+%28pf+04449913%29+Or+Azacitidine+%28aza%29+With+Or+Without+Glasdegib+In+Patients+With+Previously+Untreated+Acute+Myeloid+Leukemia] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To obtain contact information for a study center near you, click here.",null,"Yes","No",{"$nulls":17},"2017-002822-19|BRIGHT|BRIGHT AML1019","EudraCT Number|Alias Study Number","Overall survival","5 years after last subject randomized",null,"Fatigue score measured by the MD Anderson Symptom Inventory (MDASI)-AML/MDS questionnaire|Rate of Complete Remission (CR) (including CR with minimal residual disease (MRD)-negative as assessed by multiparametric flow cytometry)|Duration of response (defined as CR [includes CR-MRD negative]/CRi or CR/CRh as appropriate)|Time to response (CR[includes CR-MRD negative)]/CR with partial hematologic rcovery (CRh) as appropriate)|Event-free Survival|Patient Reported Outcomes (PROs) as measured by the M.D. Anderson Symptom Inventory AML/MDS Module (MDASI-AML/MDS)|Adverse events as graded by NCI CTCAE v4.03|Laboratory abnormalities as graded by NCI CTCAE v4.03|For the intensive study, the plasma trough concentration (Ctrough) will be analyzed|QTc interval|PROs as measured by Patient Global Impression of Change (PGIC)|Patient Reported Outcomes (PROs) as measured by EuroQoL 5 Dimension questionnaire 5-Level version (EQ-5D-5L)|Patient Reported Outcomes (PROs) as measured by Patient Global Impression of Symptoms (PGIS)|Complete Remission with incomplete hematologic recovery (CRi)|Rate of morphological leukemia-free state (MLFS)|Rate of Partial Remission (PR)|Rate of Complete Remission with partial hematological recovery (CRh) for the Non-intensive study only only|Minimum Observed Plasma Trough Concentratrion of glasdegib in the Intensive Study|Minimum Observed Plasma Trough Concentration of glasdegib in the Non-intensive study","Scale is from 0-10 where 0 is not present and 10 is as bad as you can image.|Response as defined by the 2017 European LeukemiaNet (ELN) recommendations.|5 years after last subject randomized, consent withdrawal, or death|Measurement Scale from 0-10.|PK samples taken on Induction(s) Day 1 (1 and 4 hours post induction); Induction(s) Day 10 (pre-dose, 1 and 4 hours post dose); Day 1 of each Consolidation cycle (pre-dose, 1 and 4 hours post dose)|One question asking for description of leukemia symptoms.|Series of questions that ask for information that best describes health.|One question asking for information regarding leukemia symptoms.|Its the minimum trough concentration in plasma of glasdegib following multiple daily dosing to steady state.|It is the minimum trough concentration in plasma of glasdegib following multiple daily dosing to steady state.","5 years after last subject randomized, consent withdrawal, or death|2 years after last dose of study therapy|5 years after last patient randomized, withdrawal, or death|5 years after last subject randomized, withdrawal, or death|Day 10 of Induction Cycle and Day 1 of each Consolidation Cycle|Cycle 1 Day 15 and Cycles 2 and 3 on Day 1","ClinicalTrials.gov_Inquiries@pfizer.com","Pfizer CT.gov Call Center","1-800-718-1021","Adelaide, South|Darlinghurst, New South Wales, Australia, 2010 St George HospitalKogarah, New South Wales, Australia, 2217|Salzburg, Austria, 5020 Uniklinikum Salzburg, Landeskrankenhaus Salzburg,Salzburg, Austria, 5020 Sozialmedizinisches Zentrum Sud.Wien, Austria, 1100 Krankenhaus Hietzing Mit Neurologischem Zentrum RosenhugelWien, Austria, I130|Winnipeg, Manitoba, Canada, R3E 0V9|Brno, Czechia, 625 00 Nemocnicni LekarnaBrno, Czechia, 625 00 InternÃ­ HematologickÃ¡ Klinika, Fakultni Nemocnice KrÃ¡lovskÃ© VinohradyPraha 10, Czechia, 100 34 Ãšstavni LÃ©kÃ¡rnaPraha 10, Czechia, 100 34|Creteil, France, 94010 Chu Henri MondorCrÃ©teil, France, 94010 Chu De NantesNantes Cedex 1, France, 44093 Chu De Nantes Hotel DieuNantes Cedex, France, 44093 Hopital Saint LouisParis, France, 75010 Centre Hospitalier Lyon Sud -Unite De Pharmacie Clinique OncologiquePierre Benite Cedex, France, 69495 Centre Hospitalier Lyon Sud - Service D'HematologiePierre Benite Cedex, France, 69495|Debrecen, Hungary, 4032 Debreceni Egyetem Klinikai Kozpont Belgyogyaszati KlinikaDebrecen, Hungary, 4032 Petz AladÃ¡r Megyei OktatÃ³ KÃ³rhÃ¡z, GyÃ³gyszerÃ©szeti OsztÃ¡lyGyÅ‘r, Hungary, 9024 Petz AladÃ¡r Megyei OktatÃ³ KÃ³rhÃ¡z, Ii. BelgyÃ³gyÃ¡szat- HematolÃ³giai OsztÃ¡lyGyÅ‘r, Hungary, 9024|Ancona, An, Italy, 60126 Sod Farmacia-Dipt Dei Servizi -Aou Ospedali Riuniti Umberto I, G.M. Lancisi, G. SalesiTorette Di Ancona, An, Italy, 60126|Cona, Ferrara, Fe, Italy, 44124 Farmacia OspedalieraFerrara, Fe, Italy, 44121|Nagoya, Aichi, Japan, 466-8650|Akita, Japan, 010-8543 Kyushu University HospitalFukuoka, Japan, 812-8582 National Hospital Organization Kumamoto Medical Center[Active, Not Recruiting]Kumamoto, Japan, 860-0008 Nagasaki University HospitalNagasaki, Japan, 852-8501 Tokyo Medical University HospitalTokyo, Japan, 160-0023 Korea, Republic Of, Jeollabuk-Do Chonbuk National University HospitalJeonju-Si, Jeollabuk-Do, Korea, Republic Of, 54907 Korea, Republic Of, Jeollanam-Do Chonnam National University Hwasun HospitalHwasun-Gun, Jeollanam-Do, Korea, Republic Of, 58128 Korea, Republic Of Department Of Pharmacy, Inje University Busan Paik HospitalBusan, Korea, Republic Of, 47392 Inje University Busan Paik HospitalBusan, Korea, Republic Of, 47392 Clinical Trial Pharmacy, Keimyung University Dongsan HospitalDaegu, Korea, Republic Of, 41931 Keimyung University Dongsan HospitalDaegu, Korea, Republic Of, 41931 Gachon University Gil Medical CenterIncheon, Korea, Republic Of, 21565 Seoul National University HospitalSeoul, Korea, Republic Of, 03080 Severance Hospital, Yonsei University Health SystemSeoul, Korea, Republic Of, 03722 Department Of Pharmacy, Samsung Medical CenterSeoul, Korea, Republic Of, 06351 Samsung Medical CenterSeoul, Korea, Republic Of, 06351 The Catholic University Of Korea Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591 The Catholic University Of Korea, Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591|Yoshida-Gun, Fukui, Japan, 910-1193|Maebashi, Gunma, Japan, 371-8511|Kobe-Shi, Hyogo, Japan, 650-0017|Yokohama, Kanagawa, Japan, 232-0024|Sendai, Miyagi, Japan, 980-8574|Osaka-City, Osaka, Japan, 545-8586 Kindai University HospitalOsaka-Sayama, Osaka, Japan, 589-8511|Sunto-Gun, Shizuoka, Japan, 411-8777|Tachikawa, Tokyo, Japan, 190-0014|Gdansk, Poland, 80-952 Wwcoit Im. M. Kopernika W LodziLodz, Poland, 93-513|Craiova, Dolj, Romania, 200136|Bucuresti, Romania, 010825 Spitalul Clinic Coltea, Clinica De HematologieBucuresti, Romania, 030171 Russian Federation Sbhi Cch No. 40 Hd MoscowMoscow, Russian Federation, 129301 State Budgetary Healthcare Institution Of MoscowMoscow, Russian Federation, 129301 Sbhi Nnr Nn Rch N. A. N.A. SemashkoNizhniy Novgorod, Russian Federation, 603126 State Budgetary Institution Of Ryazan Region 'Regional Clinical Hospital' (Sbi Rr Rch)Ryazan, Russian Federation, 390039 Fsbi Russrhti Fmba Of|Barcelona, Spain, 08003 Hospital De La Santa Creu I Sant PauBarcelona, Spain, 08025 Hospital Universitario Arnau De VilanovaLleida, Spain, 25198 Hospital General Universitario Gregorio MaranonMadrid, Spain, 28007 Hospital Universitario Ramon Y CajalMadrid, Spain, 28034 Hospital Universitario Virgen Del RocioSevilla, Spain, 41013 Hospital Universitari I Politecnic La FeValencia, Spain, 46026|Orebro, Sweden, 701 85 Universitetssjukhuset OrebroOrebro, Sweden, 701 85 Taiwan National Taiwan University HospitalTaipei, Taiwan, 100 Department Of Clinical Trial Pharmacy, Taipei Veterans General HospitalTaipei, Taiwan, 11217 Taipei Veterans General HospitalTaipei, Taiwan, 11217 Division Of Pharmacy, Koo Foundation Sun Yat-Sen Cancer CenterTaipei, Taiwan, 112 Koo Foundation Sun Yat-Sen Cancer CenterTaipei, Taiwan, 112 Chang Gung Memorial Hospital-Linkou BranchTaoyuan City, Taiwan, 333 Chemotherapy Pharmacy, Chang Gung Memorial Hospital-Linkou BranchTaoyuan City, Taiwan, 333|Sutton, Surrey, United Kingdom, Sm2 5Pt|London, United Kingdom, W12 0Hs|Los Angeles, California, United States, 90033 Lac+Usc Medical CenterLos Angeles, California, United States, 90033 Usc/Norris Comprehensive Cancer Center / Investigational Drug ServicesLos Angeles, California, United States, 90033 Usc/Norris Comprehensive Cancer CenterLos Angeles, California, United States, 90033 Rrmc - UclaLos Angeles, California, United States, 90095 Ucla Department Of MedicineLos Angeles, California, United States, 90095 Ucla Hematology/Oncology ClinicLos Angeles, California, United States, 90095 Ucla Ronald Reagan Medical CenterLos Angeles, California, United States, 90095 Keck Medicine Of Usc Norris Oncology/Hematology - Newport Beach Treatment CenterNewport Beach, California, United States, 92663 Usc Norris Oncology/Hematology - Newport BeachNewport Beach, California, United States, 92663 Uc Irvine Health - Chao Family Comprehensive Cancer CenterOrange, California, United States, 92868-3201 Uc Irvine Medical CenterOrange, California, United States, 92868-3201 Ucsf Helen Diller Family Comprehensive Cancer CenterSan Francisco, California, United States, 94143 University Of California, San Francisco Medical CenterSan Francisco, California, United States, 94143 University Of California, San FranciscoSan Francisco, California, United States, 94143|Boston, Massachusetts, United States, 02111|Kansas City, Missouri, United States, 64132|Lake Success, New York, United States, 11042 North Shore University HospitalManhasset, New York, United States, 11030 Long Island Jewish Medical CenterNew Hyde Park, New York, United States, 11040 University Of Rochester Cancer Center PharmacyRochester, New York, United States, 14642 University Of Rochester Medical CenterRochester, New York, United States, 14642|Cleveland, Ohio, United States, 44106 University Hospitals Cleveland Medical CenterCleveland, Ohio, United States, 44106 Cleveland Clinic FoundationCleveland, Ohio, United States, 44195|Nashville, Tennessee, United States, 37203|Dallas, Texas, United States, 75246 Baylor University Medical CenterDallas, Texas, United States, 75246 Blood Cancer And Stem Cell Transplant ClinicSan Antonio, Texas, United States, 78229 Methodist Healthcare System Of San AntonioSan Antonio, Texas, United States, 78229 Methodist Hospital Investigational PharmacySan Antonio, Texas, United States, 78229|Seattle, Washington, United States, 98104 Swedish Investigational Drug Services PharmacySeattle, Washington, United States, 98104 Swedish Medical CenterSeattle, Washington, United States, 98122","California|Massachusetts|Missouri|New York|Ohio|Tennessee|Texas|Washington","Australia|Austria|Canada|Czechia|France|Hungary|Italy|Japan|Poland|Romania|Spain|Sweden|United Kingdom|United States","Australia, 5000 Royal Adelaide Hospital|New South Wales St Vincent's Hospital Sydney|Royal Adelaide Hospital - Clinical Trials Pharmacy|Landeskrankenhaus Salzburg, Universitaetsklinik Fuer Innere Medizin Iii Der Pmu|Manitoba Cancercare Manitoba|Interni Hematologicka A Onkologicka Klinika, Fakultni Nemocnice Brno|Chu Henri Mondor|Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Klinika, Hematologia Tanszek|An Aou Ospedali Riuniti Umberto I, G.M. Lancisi, G. Salesi, Clinica Di Ematologia|Fe A.O.U. Di Ferrara- Arcispedale Sant'Anna,|Aichi Japanese Red Cross Nagoya Daini Hospital|Akita University Hospital|Fukui University Of Fukui Hospital|Gunma Gunma University Hospital|Hyogo Kobe University Hospital|Kanagawa Yokohama City University Medical Center|Miyagi Tohoku University Hospital|Osaka Osaka City University Hospital|Shizuoka Shizuoka Cancer Center|Tokyo National Hospital Organization Disaster Medical Center|Klinika Hematologii I Transplantologii Uniwersyteckie Centrum Kliniczne|Dolj Spitalul Clinic Municipal Filantropia Craiova, Sectia Clinica Hematologie|Spitalul Universitar De Urgenta Militar Central \"Dr. Carol Davila\" Bucuresti|Hospital Del Mar|Apoex Vn|, Surrey The Royal Marsden Nhs Foundation Trust|Imperial College Healthcare Nhs Trust|Keck Hospital Of Usc|Tufts Medical Center|Midamerica Division, Inc., C/O Research Medical Center|Northwell Health/Monter Cancer Center|Taussig Cancer Center Investigational Pharmacy|The Sarah Cannon Research Institute|Baylor Scott And White Research Institute|Swedish Cancer Institute",{"$nulls":3},"Pfizer CT.gov Call Center","2019-01-31","2020-05-25T16:39:33.076","2020-05-26T17:10:42.972","NCT03416179"]
["5ecbf4c5fe30261b1a0483ba","NCT03416179","2019-02-19","Pfizer","PFE","Recruiting","A Study Evaluating Intensive Chemotherapy With or Without Glasdegib or Azacitidine With or Without Glasdegib In Patients With Previously Untreated Acute Myeloid Leukemia (BRIGHT AML1019)","Glasdegib|Cytarabine|Daunorubicin|Azacitidine","Hh Inhibitor|DNA Polymerase Inhibitor|Nucleic Acid Synthesis Inhibitor|TOP2 Inhibitor|DNA Mtase Inhibitor","Unknown",null,"Unknown",null,"Phase 3",4,720,"Anticipated","2018-04-20","2021-06-13","OS","Overall Survival",{"$nulls":3},"Glasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).\n\nGlasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).","Two separate registration trials conducted under one protocol number are proposed to adequately and independently evaluate the addition of glasdegib in intensive and non-intensive chemotherapy populations. Each study will have an experimental treatment arm and a placebo arm. Endpoints are the same for each study except where specifically indicated.\n\nAssignment to the Intensive Study or the Non-Intensive Study will be made by the Investigator based on the 2017 European LeukemiaNet (ELN) recommendations.\n\nStudy B1371019 is a randomized (1:1), double-blind, multi-center, placebo controlled study of chemotherapy in combination with glasdegib versus chemotherapy in combination with placebo in adult patients with previously untreated AML.\n\nGlasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).\n\nGlasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).","A RANDOMIZED (1:1), DOUBLE-BLIND, MULTI-CENTER, PLACEBO CONTROLLED STUDY EVALUATING INTENSIVE CHEMOTHERAPY WITH OR WITHOUT GLASDEGIB (PF-04449913) OR AZACITIDINE (AZA) WITH OR WITHOUT GLASDEGIB IN PATIENTS WITH PREVIOUSLY UNTREATED ACUTE MYELOID LEUKEMIA","B1371019","Leukemia, Myeloid, Acute","Acute Leukemia|Acute Myeloid Leukemia|Myeloid Leukemia|Leukemia","Oncology Hematological","Oncology","Experimental|Placebo Comparator","Arm A (Intensive Study)|Arm B (Intensive Study)|Arm A (Non-intensive study)|Arm B (Non-intensive study)","Glasdegib + '7+3' Induction(s)|Placebo + '7+3' Induction(s)|Glasdegib + azacitidine|Placebo + azacitidine","Drug|Procedure","glasdegib|daunorubicin + cytarabine|cytarabine|HSCT|Placebo|azacitidine","Daily Glasdegib (100 mg, PO), beginning on Day 1 and is to continue up to 2 years post randomization.\n\nFollowing consolidation therapy, glasdegib or placebo will be administered daily for up to 2 years after randomization or until they have minimal residual disease (MRD) negative disease, whichever comes first.\n\nDaily Glasdegib (100 mg, PO) or matching placebo will continue throughout Induction(s) and Consolidation therapies regardless of dose modifications/delays in the chemotherapy.|Consolidation with single agent cytarabine 3 g/m2 IV for adults <60 years and 1 g/m2 for adults 60 years over 3 BID on Days 1, 3, and 5, every 28 days for up to 4 cycles or alternative single agent cytarabine consolidation schedules may be used per local prescribing information.|If required, and done per standard of care post Induction(s).|Azacitidine (75 mg/m2, SC or IV) daily for 7 days, in 28 day cycles for as long as they do not meet the criteria for disease progression, unacceptable toxicity, consent withdrawal, or death.|Matching placebo (PO) is to be administered by mouth daily beginning on Day 1 of chemotherapy and will continue if subjects demonstrate reasonable evidence of clinical benefit and do not meet the criteria for progression regardless of any delays/modifications in the chemotherapy treatment. Subjects will continue placebo until disease progression, unacceptable toxicity, consent withdrawal, or death, whichever comes first.","PF-04449913","Arm A (Intensive Study)|Arm B (Intensive Study)|Arm A (Non-intensive study)|Arm B (Non-intensive study)","\n\nSubjects must meet all of the following inclusion criteria to be eligible for enrollment into the Intensive and Non Intensive study (unless where indicated):\n\n 1.  Subjects with untreated AML according to the World Health Organization (WHO) 2016 Classification2, including those with: * AML arising from MDS or another antecedent hematologic disease (AHD).\n      * AML after previous cytotoxic therapy or radiation (secondary AML).\n     \n     \n 2.  18 years of age (In Japan, 20 years of age).\n 3.  Adequate Organ Function as defined by the following: * Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) 3 x upper limit of normal (ULN), excluding subjects with liver function abnormalities due to underlying malignancy.\n      * Total serum bilirubin 2 x ULN (except subjects with documented Gilbert's syndrome).\n      * Estimated creatinine clearance 30 mL/min as calculated using the standard method for the institution.\n     \n     \n 4.  QTc interval 470 msec using the Fridericia correction (QTcF).\n 5.  All anti cancer treatments (unless specified) should be discontinued 2 weeks from study entry, for example: targeted chemotherapy, radiotherapy, investigational agents, hormones, anagrelide or cytokines. * For control of rapidly progressing leukemia, all trans retinoic acid (ATRA), hydroxyurea, and/or leukopheresis may be used before and for up to 1 week after the first dose of glasdegib.\n     \n     \n 6.  Serum or urine pregnancy test (for female subjects of childbearing potential) with a minimum sensitivity of 25 IU/L or equivalent units of human chorionic gonadotropin (hCG) negative at screening.\n 7.  Male and female subjects of childbearing potential and at risk for pregnancy must agree to use at least one highly effective method of contraception throughout the study and for 180 days after the last dose of azacitidine, cytarabine, or daunorubicin; and the last dose of glasdegib or placebo, whichever occurs later.\n 8.  Female subjects of non childbearing potential must meet at least 1 of the following criteria: 1. Have undergone a documented hysterectomy and/or bilateral oophorectomy;\n      2. Have medically confirmed ovarian failure; or\n      3. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; status may be confirmed by having a serum follicle stimulating hormone (FSH) level confirming the postmenopausal state.\n     \n     All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential.\n     \n     \n 9.  Consent to a saliva sample collection for a germline comparator, unless prohibited by local regulations or ethics committee (EC) decision.\n 10. Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.\n 11. Subjects who are willing and able to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures (including bone marrow [BM] assessments).\n\n","\n\nSubjects with any of the following characteristics/conditions will not be included in the study:\n\n 1.  Acute Promyelocytic Leukemia (APL) and APLwith PML RARA, subjects (WHO 2016 classification).\n 2.  AML with BCR ABL1 or t(9;22)(q34;q11.2) as a sole abnormality. * Complex genetics may include t(9;22) cytogenetic translocation.\n     \n     \n 3.  Subjects with known active CNS leukemia.\n 4.  Participation in other clinical studies involving other investigational drug(s) (Phases 1 4) within 4 weeks prior study entry and/or during study participation.\n 5.  Subjects known to be refractory to platelet or packed red cell transfusions per Institutional Guidelines, or a patient who refuses blood product support.\n 6.  Subjects with another active malignancy on treatment with the exception of basal cell carcinoma, non melanoma skin cancer, cervical carcinoma in situ. Other prior or concurrent malignancies will be considered on a case by case basis.\n 7.  Any one of the following ongoing or in the previous 6 months: myocardial infarction, congenital long QT syndrome, Torsades de pointes, symptomatic arrhythmias (including sustained ventricular tachyarrhythmia), right or left bundle branch block and bifascicular block, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (CHF New York Heart Association class III or IV), cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism; as well as bradycardia defined as <50 bpms.\n 8.  Subjects with an active, life threatening or clinically significant uncontrolled systemic infection not related to AML.\n 9.  Subjects with left ventricular ejection fraction (LVEF) <50% are excluded from the Intensive Chemotherapy Study only.\n 10. Cumulative anthracycline dose equivalent of 550 mg/m2 of daunorubicin for the Intensive Chemotherapy Study only.\n 11. Known malabsorption syndrome or other condition that may significantly impair absorption of study medication in the investigator's judgment (eg, gastrectomy, lap band, Crohn's disease) and inability or unwillingness to swallow tablets or capsules.\n 12. Current use or anticipated requirement for drugs that are known strong CYP3A4/5 inducers.\n 13. Concurrent administration of herbal preparations.\n 14. Major surgery or radiation within 4 weeks of starting study treatment.\n 15. Documented or suspected hypersensitivity to any one of the following: * For subjects assigned to intensive chemotherapy, documented or suspected hypersensitivity to cytarabine (not including drug fever or exanthema, including known cerebellar side effects) or daunorubicin.\n      * For subjects assigned to non intensive chemotherapy, documented or suspected hypersensitivity to azacitidine or mannitol.\n     \n     \n 16. Known active drug or alcohol abuse.\n 17. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.\n 18. Pregnant females or breastfeeding female subjects.\n 19. Known recent or active suicidal ideation or behavior.\n 20. Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.","FSH",null,"Protein","Ovary","Actual","2018-01-31","Actual","Anticipated","2025-07-22","Anticipated","2019-02-01","2017-12-21","2018-01-23","2019-02-17","Yes","glasdegib;\nuntreated;\nHedgehog Inhibitor","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"All",null,"No","Yes\nPfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",null,"URL: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1371019&StudyName=A+Randomized+%281%3A1%29%2C+Double+Blind%2C+Multi+Center%2C+Placebo+Controlled+Study+Evaluating+Intensive+Chemotherapy+With+Or+Without+Glasdegib+%28pf+04449913%29+Or+Azacitidine+%28aza%29+With+Or+Without+Glasdegib+In+Patients+With+Previously+Untreated+Acute+Myeloid+Leukemia [https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1371019&StudyName=A+Randomized+%281%3A1%29%2C+Double+Blind%2C+Multi+Center%2C+Placebo+Controlled+Study+Evaluating+Intensive+Chemotherapy+With+Or+Without+Glasdegib+%28pf+04449913%29+Or+Azacitidine+%28aza%29+With+Or+Without+Glasdegib+In+Patients+With+Previously+Untreated+Acute+Myeloid+Leukemia] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To obtain contact information for a study center near you, click here.",null,"Yes","No",{"$nulls":17},"2017-002822-19|BRIGHT|BRIGHT AML1019","EudraCT Number|Alias Study Number","Overall survival","5 years after last subject randomized",null,"Fatigue score measured by the MD Anderson Symptom Inventory (MDASI)-AML/MDS questionnaire|Rate of Complete Remission (CR) (including CR with minimal residual disease (MRD)-negative as assessed by multiparametric flow cytometry)|Duration of response (defined as CR [includes CR-MRD negative]/CRi or CR/CRh as appropriate)|Time to response (CR[includes CR-MRD negative)]/CR with partial hematologic rcovery (CRh) as appropriate)|Event-free Survival|Patient Reported Outcomes (PROs) as measured by the M.D. Anderson Symptom Inventory AML/MDS Module (MDASI-AML/MDS)|Adverse events as graded by NCI CTCAE v4.03|Laboratory abnormalities as graded by NCI CTCAE v4.03|For the intensive study, the plasma trough concentration (Ctrough) will be analyzed|QTc interval|PROs as measured by Patient Global Impression of Change (PGIC)|Patient Reported Outcomes (PROs) as measured by EuroQoL 5 Dimension questionnaire 5-Level version (EQ-5D-5L)|Patient Reported Outcomes (PROs) as measured by Patient Global Impression of Symptoms (PGIS)|Complete Remission with incomplete hematologic recovery (CRi)|Rate of morphological leukemia-free state (MLFS)|Rate of Partial Remission (PR)|Rate of Complete Remission with partial hematological recovery (CRh) for the Non-intensive study only only|Minimum Observed Plasma Trough Concentratrion of glasdegib in the Intensive Study|Minimum Observed Plasma Trough Concentration of glasdegib in the Non-intensive study","Scale is from 0-10 where 0 is not present and 10 is as bad as you can image.|Response as defined by the 2017 European LeukemiaNet (ELN) recommendations.|5 years after last subject randomized, consent withdrawal, or death|Measurement Scale from 0-10.|PK samples taken on Induction(s) Day 1 (1 and 4 hours post induction); Induction(s) Day 10 (pre-dose, 1 and 4 hours post dose); Day 1 of each Consolidation cycle (pre-dose, 1 and 4 hours post dose)|One question asking for description of leukemia symptoms.|Series of questions that ask for information that best describes health.|One question asking for information regarding leukemia symptoms.|Its the minimum trough concentration in plasma of glasdegib following multiple daily dosing to steady state.|It is the minimum trough concentration in plasma of glasdegib following multiple daily dosing to steady state.","5 years after last subject randomized, consent withdrawal, or death|2 years after last dose of study therapy|5 years after last patient randomized, withdrawal, or death|5 years after last subject randomized, withdrawal, or death|Day 10 of Induction Cycle and Day 1 of each Consolidation Cycle|Cycle 1 Day 15 and Cycles 2 and 3 on Day 1","ClinicalTrials.gov_Inquiries@pfizer.com","Pfizer CT.gov Call Center","1-800-718-1021","Adelaide, South|Darlinghurst, New South Wales, Australia, 2010 St George HospitalKogarah, New South Wales, Australia, 2217|Salzburg, Austria, 5020 Uniklinikum Salzburg, Landeskrankenhaus Salzburg,Salzburg, Austria, 5020 Sozialmedizinisches Zentrum Sud.Wien, Austria, 1100 Krankenhaus Hietzing Mit Neurologischem Zentrum RosenhugelWien, Austria, I130|Winnipeg, Manitoba, Canada, R3E 0V9|Brno, Czechia, 625 00 Nemocnicni LekarnaBrno, Czechia, 625 00 InternÃ­ HematologickÃ¡ Klinika, Fakultni Nemocnice KrÃ¡lovskÃ© VinohradyPraha 10, Czechia, 100 34 Ãšstavni LÃ©kÃ¡rnaPraha 10, Czechia, 100 34|Creteil, France, 94010 Chu Henri MondorCrÃ©teil, France, 94010 Chu De NantesNantes Cedex 1, France, 44093 Chu De Nantes Hotel DieuNantes Cedex, France, 44093 Hopital Saint LouisParis, France, 75010 Centre Hospitalier Lyon Sud -Unite De Pharmacie Clinique OncologiquePierre Benite Cedex, France, 69495 Centre Hospitalier Lyon Sud - Service D'HematologiePierre Benite Cedex, France, 69495|Debrecen, Hungary, 4032 Debreceni Egyetem Klinikai Kozpont Belgyogyaszati KlinikaDebrecen, Hungary, 4032 Petz AladÃ¡r Megyei OktatÃ³ KÃ³rhÃ¡z, GyÃ³gyszerÃ©szeti OsztÃ¡lyGyÅ‘r, Hungary, 9024 Petz AladÃ¡r Megyei OktatÃ³ KÃ³rhÃ¡z, Ii. BelgyÃ³gyÃ¡szat- HematolÃ³giai OsztÃ¡lyGyÅ‘r, Hungary, 9024|Ancona, An, Italy, 60126 Sod Farmacia-Dipt Dei Servizi -Aou Ospedali Riuniti Umberto I, G.M. Lancisi, G. SalesiTorette Di Ancona, An, Italy, 60126|Cona, Ferrara, Fe, Italy, 44124 Farmacia OspedalieraFerrara, Fe, Italy, 44121|Nagoya, Aichi, Japan, 466-8650|Akita, Japan, 010-8543 Kyushu University HospitalFukuoka, Japan, 812-8582 National Hospital Organization Kumamoto Medical Center[Active, Not Recruiting]Kumamoto, Japan, 860-0008 Nagasaki University HospitalNagasaki, Japan, 852-8501 Tokyo Medical University HospitalTokyo, Japan, 160-0023 Korea, Republic Of, Jeollabuk-Do Chonbuk National University HospitalJeonju-Si, Jeollabuk-Do, Korea, Republic Of, 54907 Korea, Republic Of, Jeollanam-Do Chonnam National University Hwasun HospitalHwasun-Gun, Jeollanam-Do, Korea, Republic Of, 58128 Korea, Republic Of Department Of Pharmacy, Inje University Busan Paik HospitalBusan, Korea, Republic Of, 47392 Inje University Busan Paik HospitalBusan, Korea, Republic Of, 47392 Clinical Trial Pharmacy, Keimyung University Dongsan HospitalDaegu, Korea, Republic Of, 41931 Keimyung University Dongsan HospitalDaegu, Korea, Republic Of, 41931 Gachon University Gil Medical CenterIncheon, Korea, Republic Of, 21565 Seoul National University HospitalSeoul, Korea, Republic Of, 03080 Severance Hospital, Yonsei University Health SystemSeoul, Korea, Republic Of, 03722 Department Of Pharmacy, Samsung Medical CenterSeoul, Korea, Republic Of, 06351 Samsung Medical CenterSeoul, Korea, Republic Of, 06351 The Catholic University Of Korea Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591 The Catholic University Of Korea, Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591|Yoshida-Gun, Fukui, Japan, 910-1193|Maebashi, Gunma, Japan, 371-8511|Kobe-Shi, Hyogo, Japan, 650-0017|Yokohama, Kanagawa, Japan, 232-0024|Sendai, Miyagi, Japan, 980-8574|Osaka-City, Osaka, Japan, 545-8586 Kindai University HospitalOsaka-Sayama, Osaka, Japan, 589-8511|Sunto-Gun, Shizuoka, Japan, 411-8777|Tachikawa, Tokyo, Japan, 190-0014|Gdansk, Poland, 80-952 Wwcoit Im. M. Kopernika W LodziLodz, Poland, 93-513|Craiova, Dolj, Romania, 200136|Bucuresti, Romania, 010825 Spitalul Clinic Coltea, Clinica De HematologieBucuresti, Romania, 030171 Russian Federation Sbhi Cch No. 40 Hd MoscowMoscow, Russian Federation, 129301 State Budgetary Healthcare Institution Of MoscowMoscow, Russian Federation, 129301 Sbhi Nnr Nn Rch N. A. N.A. SemashkoNizhniy Novgorod, Russian Federation, 603126 State Budgetary Institution Of Ryazan Region 'Regional Clinical Hospital' (Sbi Rr Rch)Ryazan, Russian Federation, 390039 Fsbi Russrhti Fmba Of|Barcelona, Spain, 08003 Hospital De La Santa Creu I Sant PauBarcelona, Spain, 08025 Hospital Universitario Arnau De VilanovaLleida, Spain, 25198 Hospital General Universitario Gregorio MaranonMadrid, Spain, 28007 Hospital Universitario Ramon Y CajalMadrid, Spain, 28034 Hospital Universitario Virgen Del RocioSevilla, Spain, 41013 Hospital Universitari I Politecnic La FeValencia, Spain, 46026|Orebro, Sweden, 701 85 Universitetssjukhuset OrebroOrebro, Sweden, 701 85 Taiwan National Cheng Kung University HospitalTainan, Taiwan, 704 National Taiwan University HospitalTaipei, Taiwan, 100 Department Of Clinical Trial Pharmacy, Taipei Veterans General HospitalTaipei, Taiwan, 11217 Taipei Veterans General HospitalTaipei, Taiwan, 11217 Division Of Pharmacy, Koo Foundation Sun Yat-Sen Cancer CenterTaipei, Taiwan, 112 Koo Foundation Sun Yat-Sen Cancer CenterTaipei, Taiwan, 112 Chang Gung Memorial Hospital-Linkou BranchTaoyuan City, Taiwan, 333 Chemotherapy Pharmacy, Chang Gung Memorial Hospital-Linkou BranchTaoyuan City, Taiwan, 333|Sutton, Surrey, United Kingdom, Sm2 5Pt|London, United Kingdom, W12 0Hs|Los Angeles, California, United States, 90033 Lac+Usc Medical CenterLos Angeles, California, United States, 90033 Usc/Norris Comprehensive Cancer Center / Investigational Drug ServicesLos Angeles, California, United States, 90033 Usc/Norris Comprehensive Cancer CenterLos Angeles, California, United States, 90033 Rrmc - UclaLos Angeles, California, United States, 90095 Ucla Department Of MedicineLos Angeles, California, United States, 90095 Ucla Hematology/Oncology ClinicLos Angeles, California, United States, 90095 Ucla Ronald Reagan Medical CenterLos Angeles, California, United States, 90095 Keck Medicine Of Usc Norris Oncology/Hematology - Newport Beach Treatment CenterNewport Beach, California, United States, 92663 Usc Norris Oncology/Hematology - Newport BeachNewport Beach, California, United States, 92663 Uc Irvine Health - Chao Family Comprehensive Cancer CenterOrange, California, United States, 92868-3201 Uc Irvine Medical CenterOrange, California, United States, 92868-3201 Ucsf Helen Diller Family Comprehensive Cancer CenterSan Francisco, California, United States, 94143 University Of California, San Francisco Medical CenterSan Francisco, California, United States, 94143 University Of California, San FranciscoSan Francisco, California, United States, 94143|Boston, Massachusetts, United States, 02111|Kansas City, Missouri, United States, 64132|Lake Success, New York, United States, 11042 North Shore University HospitalManhasset, New York, United States, 11030 Long Island Jewish Medical CenterNew Hyde Park, New York, United States, 11040 University Of Rochester Cancer Center PharmacyRochester, New York, United States, 14642 University Of Rochester Medical CenterRochester, New York, United States, 14642|Cleveland, Ohio, United States, 44106 University Hospitals Cleveland Medical CenterCleveland, Ohio, United States, 44106 Cleveland Clinic FoundationCleveland, Ohio, United States, 44195|Nashville, Tennessee, United States, 37203|Dallas, Texas, United States, 75246 Baylor University Medical CenterDallas, Texas, United States, 75246 Blood Cancer And Stem Cell Transplant ClinicSan Antonio, Texas, United States, 78229 Methodist Healthcare System Of San AntonioSan Antonio, Texas, United States, 78229 Methodist Hospital Investigational PharmacySan Antonio, Texas, United States, 78229|Seattle, Washington, United States, 98104 Swedish Investigational Drug Services PharmacySeattle, Washington, United States, 98104 Swedish Medical CenterSeattle, Washington, United States, 98122","California|Massachusetts|Missouri|New York|Ohio|Tennessee|Texas|Washington","Australia|Austria|Canada|Czechia|France|Hungary|Italy|Japan|Poland|Romania|Spain|Sweden|United Kingdom|United States","Australia, 5000 Royal Adelaide Hospital|New South Wales St Vincent's Hospital Sydney|Royal Adelaide Hospital - Clinical Trials Pharmacy|Landeskrankenhaus Salzburg, Universitaetsklinik Fuer Innere Medizin Iii Der Pmu|Manitoba Cancercare Manitoba|Interni Hematologicka A Onkologicka Klinika, Fakultni Nemocnice Brno|Chu Henri Mondor|Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Klinika, Hematologia Tanszek|An Aou Ospedali Riuniti Umberto I, G.M. Lancisi, G. Salesi, Clinica Di Ematologia|Fe A.O.U. Di Ferrara- Arcispedale Sant'Anna,|Aichi Japanese Red Cross Nagoya Daini Hospital|Akita University Hospital|Fukui University Of Fukui Hospital|Gunma Gunma University Hospital|Hyogo Kobe University Hospital|Kanagawa Yokohama City University Medical Center|Miyagi Tohoku University Hospital|Osaka Osaka City University Hospital|Shizuoka Shizuoka Cancer Center|Tokyo National Hospital Organization Disaster Medical Center|Klinika Hematologii I Transplantologii Uniwersyteckie Centrum Kliniczne|Dolj Spitalul Clinic Municipal Filantropia Craiova, Sectia Clinica Hematologie|Spitalul Universitar De Urgenta Militar Central \"Dr. Carol Davila\" Bucuresti|Hospital Del Mar|Apoex Vn|, Surrey The Royal Marsden Nhs Foundation Trust|Imperial College Healthcare Nhs Trust|Keck Hospital Of Usc|Tufts Medical Center|Midamerica Division, Inc., C/O Research Medical Center|Northwell Health/Monter Cancer Center|Taussig Cancer Center Investigational Pharmacy|The Sarah Cannon Research Institute|Baylor Scott And White Research Institute|Swedish Cancer Institute",{"$nulls":3},"Pfizer CT.gov Call Center","2019-02-17","2020-05-25T16:39:33.088","2020-05-26T17:10:42.972","NCT03416179"]
["5ecbf4c511702c1b1b916bc7","NCT03416179","2019-03-05","Pfizer","PFE","Recruiting","A Study Evaluating Intensive Chemotherapy With or Without Glasdegib or Azacitidine With or Without Glasdegib In Patients With Previously Untreated Acute Myeloid Leukemia (BRIGHT AML1019)","Glasdegib|Cytarabine|Daunorubicin|Azacitidine","Hh Inhibitor|DNA Polymerase Inhibitor|Nucleic Acid Synthesis Inhibitor|TOP2 Inhibitor|DNA Mtase Inhibitor","Unknown",null,"Unknown",null,"Phase 3",4,720,"Anticipated","2018-04-20","2021-06-13","OS","Overall Survival",{"$nulls":3},"Glasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).\n\nGlasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).","Two separate registration trials conducted under one protocol number are proposed to adequately and independently evaluate the addition of glasdegib in intensive and non-intensive chemotherapy populations. Each study will have an experimental treatment arm and a placebo arm. Endpoints are the same for each study except where specifically indicated.\n\nAssignment to the Intensive Study or the Non-Intensive Study will be made by the Investigator based on the 2017 European LeukemiaNet (ELN) recommendations.\n\nStudy B1371019 is a randomized (1:1), double-blind, multi-center, placebo controlled study of chemotherapy in combination with glasdegib versus chemotherapy in combination with placebo in adult patients with previously untreated AML.\n\nGlasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).\n\nGlasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).","A RANDOMIZED (1:1), DOUBLE-BLIND, MULTI-CENTER, PLACEBO CONTROLLED STUDY EVALUATING INTENSIVE CHEMOTHERAPY WITH OR WITHOUT GLASDEGIB (PF-04449913) OR AZACITIDINE (AZA) WITH OR WITHOUT GLASDEGIB IN PATIENTS WITH PREVIOUSLY UNTREATED ACUTE MYELOID LEUKEMIA","B1371019","Leukemia, Myeloid, Acute","Acute Leukemia|Acute Myeloid Leukemia|Myeloid Leukemia|Leukemia","Oncology Hematological","Oncology","Experimental|Placebo Comparator","Arm A (Intensive Study)|Arm B (Intensive Study)|Arm A (Non-intensive study)|Arm B (Non-intensive study)","Glasdegib + '7+3' Induction(s)|Placebo + '7+3' Induction(s)|Glasdegib + azacitidine|Placebo + azacitidine","Drug|Procedure","glasdegib|daunorubicin + cytarabine|cytarabine|HSCT|Placebo|azacitidine","Daily Glasdegib (100 mg, PO), beginning on Day 1 and is to continue up to 2 years post randomization.\n\nFollowing consolidation therapy, glasdegib or placebo will be administered daily for up to 2 years after randomization or until they have minimal residual disease (MRD) negative disease, whichever comes first.\n\nDaily Glasdegib (100 mg, PO) or matching placebo will continue throughout Induction(s) and Consolidation therapies regardless of dose modifications/delays in the chemotherapy.|Consolidation with single agent cytarabine 3 g/m2 IV for adults <60 years and 1 g/m2 for adults 60 years over 3 BID on Days 1, 3, and 5, every 28 days for up to 4 cycles or alternative single agent cytarabine consolidation schedules may be used per local prescribing information.|If required, and done per standard of care post Induction(s).|Azacitidine (75 mg/m2, SC or IV) daily for 7 days, in 28 day cycles for as long as they do not meet the criteria for disease progression, unacceptable toxicity, consent withdrawal, or death.|Matching placebo (PO) is to be administered by mouth daily beginning on Day 1 of chemotherapy and will continue if subjects demonstrate reasonable evidence of clinical benefit and do not meet the criteria for progression regardless of any delays/modifications in the chemotherapy treatment. Subjects will continue placebo until disease progression, unacceptable toxicity, consent withdrawal, or death, whichever comes first.","PF-04449913","Arm A (Intensive Study)|Arm B (Intensive Study)|Arm A (Non-intensive study)|Arm B (Non-intensive study)","\n\nSubjects must meet all of the following inclusion criteria to be eligible for enrollment into the Intensive and Non Intensive study (unless where indicated):\n\n 1.  Subjects with untreated AML according to the World Health Organization (WHO) 2016 Classification2, including those with: * AML arising from MDS or another antecedent hematologic disease (AHD).\n      * AML after previous cytotoxic therapy or radiation (secondary AML).\n     \n     \n 2.  18 years of age (In Japan, 20 years of age).\n 3.  Adequate Organ Function as defined by the following: * Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) 3 x upper limit of normal (ULN), excluding subjects with liver function abnormalities due to underlying malignancy.\n      * Total serum bilirubin 2 x ULN (except subjects with documented Gilbert's syndrome).\n      * Estimated creatinine clearance 30 mL/min as calculated using the standard method for the institution.\n     \n     \n 4.  QTc interval 470 msec using the Fridericia correction (QTcF).\n 5.  All anti cancer treatments (unless specified) should be discontinued 2 weeks from study entry, for example: targeted chemotherapy, radiotherapy, investigational agents, hormones, anagrelide or cytokines. * For control of rapidly progressing leukemia, all trans retinoic acid (ATRA), hydroxyurea, and/or leukopheresis may be used before and for up to 1 week after the first dose of glasdegib.\n     \n     \n 6.  Serum or urine pregnancy test (for female subjects of childbearing potential) with a minimum sensitivity of 25 IU/L or equivalent units of human chorionic gonadotropin (hCG) negative at screening.\n 7.  Male and female subjects of childbearing potential and at risk for pregnancy must agree to use at least one highly effective method of contraception throughout the study and for 180 days after the last dose of azacitidine, cytarabine, or daunorubicin; and the last dose of glasdegib or placebo, whichever occurs later.\n 8.  Female subjects of non childbearing potential must meet at least 1 of the following criteria: 1. Have undergone a documented hysterectomy and/or bilateral oophorectomy;\n      2. Have medically confirmed ovarian failure; or\n      3. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; status may be confirmed by having a serum follicle stimulating hormone (FSH) level confirming the postmenopausal state.\n     \n     All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential.\n     \n     \n 9.  Consent to a saliva sample collection for a germline comparator, unless prohibited by local regulations or ethics committee (EC) decision.\n 10. Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.\n 11. Subjects who are willing and able to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures (including bone marrow [BM] assessments).\n\n","\n\nSubjects with any of the following characteristics/conditions will not be included in the study:\n\n 1.  Acute Promyelocytic Leukemia (APL) and APLwith PML RARA, subjects (WHO 2016 classification).\n 2.  AML with BCR ABL1 or t(9;22)(q34;q11.2) as a sole abnormality. * Complex genetics may include t(9;22) cytogenetic translocation.\n     \n     \n 3.  Subjects with known active CNS leukemia.\n 4.  Participation in other clinical studies involving other investigational drug(s) (Phases 1 4) within 4 weeks prior study entry and/or during study participation.\n 5.  Subjects known to be refractory to platelet or packed red cell transfusions per Institutional Guidelines, or a patient who refuses blood product support.\n 6.  Subjects with another active malignancy on treatment with the exception of basal cell carcinoma, non melanoma skin cancer, cervical carcinoma in situ. Other prior or concurrent malignancies will be considered on a case by case basis.\n 7.  Any one of the following ongoing or in the previous 6 months: myocardial infarction, congenital long QT syndrome, Torsades de pointes, symptomatic arrhythmias (including sustained ventricular tachyarrhythmia), right or left bundle branch block and bifascicular block, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (CHF New York Heart Association class III or IV), cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism; as well as bradycardia defined as <50 bpms.\n 8.  Subjects with an active, life threatening or clinically significant uncontrolled systemic infection not related to AML.\n 9.  Subjects with left ventricular ejection fraction (LVEF) <50% are excluded from the Intensive Chemotherapy Study only.\n 10. Cumulative anthracycline dose equivalent of 550 mg/m2 of daunorubicin for the Intensive Chemotherapy Study only.\n 11. Known malabsorption syndrome or other condition that may significantly impair absorption of study medication in the investigator's judgment (eg, gastrectomy, lap band, Crohn's disease) and inability or unwillingness to swallow tablets or capsules.\n 12. Current use or anticipated requirement for drugs that are known strong CYP3A4/5 inducers.\n 13. Concurrent administration of herbal preparations.\n 14. Major surgery or radiation within 4 weeks of starting study treatment.\n 15. Documented or suspected hypersensitivity to any one of the following: * For subjects assigned to intensive chemotherapy, documented or suspected hypersensitivity to cytarabine (not including drug fever or exanthema, including known cerebellar side effects) or daunorubicin.\n      * For subjects assigned to non intensive chemotherapy, documented or suspected hypersensitivity to azacitidine or mannitol.\n     \n     \n 16. Known active drug or alcohol abuse.\n 17. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.\n 18. Pregnant females or breastfeeding female subjects.\n 19. Known recent or active suicidal ideation or behavior.\n 20. Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.","FSH",null,"Protein","Ovary","Actual","2018-01-31","Actual","Anticipated","2025-07-22","Anticipated","2019-03-01","2017-12-21","2018-01-23","2019-03-03","Yes","glasdegib;\nuntreated;\nHedgehog Inhibitor","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"All",null,"No","Yes\nPfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",null,"URL: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1371019&StudyName=A+Randomized+%281%3A1%29%2C+Double+Blind%2C+Multi+Center%2C+Placebo+Controlled+Study+Evaluating+Intensive+Chemotherapy+With+Or+Without+Glasdegib+%28pf+04449913%29+Or+Azacitidine+%28aza%29+With+Or+Without+Glasdegib+In+Patients+With+Previously+Untreated+Acute+Myeloid+Leukemia [https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1371019&StudyName=A+Randomized+%281%3A1%29%2C+Double+Blind%2C+Multi+Center%2C+Placebo+Controlled+Study+Evaluating+Intensive+Chemotherapy+With+Or+Without+Glasdegib+%28pf+04449913%29+Or+Azacitidine+%28aza%29+With+Or+Without+Glasdegib+In+Patients+With+Previously+Untreated+Acute+Myeloid+Leukemia] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To obtain contact information for a study center near you, click here.",null,"Yes","No",{"$nulls":17},"2017-002822-19|BRIGHT|BRIGHT AML1019","EudraCT Number|Alias Study Number","Overall survival","5 years after last subject randomized",null,"Fatigue score measured by the MD Anderson Symptom Inventory (MDASI)-AML/MDS questionnaire|Rate of Complete Remission (CR) (including CR with minimal residual disease (MRD)-negative as assessed by multiparametric flow cytometry)|Duration of response (defined as CR [includes CR-MRD negative]/CRi or CR/CRh as appropriate)|Time to response (CR[includes CR-MRD negative)]/CR with partial hematologic rcovery (CRh) as appropriate)|Event-free Survival|Patient Reported Outcomes (PROs) as measured by the M.D. Anderson Symptom Inventory AML/MDS Module (MDASI-AML/MDS)|Adverse events as graded by NCI CTCAE v4.03|Laboratory abnormalities as graded by NCI CTCAE v4.03|For the intensive study, the plasma trough concentration (Ctrough) will be analyzed|QTc interval|PROs as measured by Patient Global Impression of Change (PGIC)|Patient Reported Outcomes (PROs) as measured by EuroQoL 5 Dimension questionnaire 5-Level version (EQ-5D-5L)|Patient Reported Outcomes (PROs) as measured by Patient Global Impression of Symptoms (PGIS)|Complete Remission with incomplete hematologic recovery (CRi)|Rate of morphological leukemia-free state (MLFS)|Rate of Partial Remission (PR)|Rate of Complete Remission with partial hematological recovery (CRh) for the Non-intensive study only only|Minimum Observed Plasma Trough Concentratrion of glasdegib in the Intensive Study|Minimum Observed Plasma Trough Concentration of glasdegib in the Non-intensive study","Scale is from 0-10 where 0 is not present and 10 is as bad as you can image.|Response as defined by the 2017 European LeukemiaNet (ELN) recommendations.|5 years after last subject randomized, consent withdrawal, or death|Measurement Scale from 0-10.|PK samples taken on Induction(s) Day 1 (1 and 4 hours post induction); Induction(s) Day 10 (pre-dose, 1 and 4 hours post dose); Day 1 of each Consolidation cycle (pre-dose, 1 and 4 hours post dose)|One question asking for description of leukemia symptoms.|Series of questions that ask for information that best describes health.|One question asking for information regarding leukemia symptoms.|Its the minimum trough concentration in plasma of glasdegib following multiple daily dosing to steady state.|It is the minimum trough concentration in plasma of glasdegib following multiple daily dosing to steady state.","5 years after last subject randomized, consent withdrawal, or death|2 years after last dose of study therapy|5 years after last patient randomized, withdrawal, or death|5 years after last subject randomized, withdrawal, or death|Day 10 of Induction Cycle and Day 1 of each Consolidation Cycle|Cycle 1 Day 15 and Cycles 2 and 3 on Day 1","ClinicalTrials.gov_Inquiries@pfizer.com","Pfizer CT.gov Call Center","1-800-718-1021","Adelaide, South|Darlinghurst, New South Wales, Australia, 2010 St George HospitalKogarah, New South Wales, Australia, 2217|Salzburg, Austria, 5020 Uniklinikum Salzburg, Landeskrankenhaus Salzburg,Salzburg, Austria, 5020 Sozialmedizinisches Zentrum Sud.Wien, Austria, 1100 Krankenhaus Hietzing Mit Neurologischem Zentrum RosenhugelWien, Austria, I130|Winnipeg, Manitoba, Canada, R3E 0V9|Brno, Czechia, 625 00 Nemocnicni LekarnaBrno, Czechia, 625 00 InternÃ­ HematologickÃ¡ Klinika, Fakultni Nemocnice KrÃ¡lovskÃ© VinohradyPraha 10, Czechia, 100 34 Ãšstavni LÃ©kÃ¡rnaPraha 10, Czechia, 100 34|Creteil, France, 94010 Chu Henri MondorCrÃ©teil, France, 94010 Chu De NantesNantes Cedex 1, France, 44093 Chu De Nantes Hotel DieuNantes Cedex, France, 44093 Hopital Saint LouisParis, France, 75010 Centre Hospitalier Lyon Sud -Unite De Pharmacie Clinique OncologiquePierre Benite Cedex, France, 69495 Centre Hospitalier Lyon Sud - Service D'HematologiePierre Benite Cedex, France, 69495|Debrecen, Hungary, 4032 Debreceni Egyetem Klinikai Kozpont Belgyogyaszati KlinikaDebrecen, Hungary, 4032 Petz AladÃ¡r Megyei OktatÃ³ KÃ³rhÃ¡z, GyÃ³gyszerÃ©szeti OsztÃ¡lyGyÅ‘r, Hungary, 9024 Petz AladÃ¡r Megyei OktatÃ³ KÃ³rhÃ¡z, Ii. BelgyÃ³gyÃ¡szat- HematolÃ³giai OsztÃ¡lyGyÅ‘r, Hungary, 9024|Ancona, An, Italy, 60126 Sod Farmacia-Dipt Dei Servizi -Aou Ospedali Riuniti Umberto I, G.M. Lancisi, G. SalesiTorette Di Ancona, An, Italy, 60126|Cona, Ferrara, Fe, Italy, 44124 Farmacia OspedalieraFerrara, Fe, Italy, 44121|Pesaro, Pu, Italy, 61122|Nagoya, Aichi, Japan, 466-8650|Akita, Japan, 010-8543 Kyushu University HospitalFukuoka, Japan, 812-8582 National Hospital Organization Kumamoto Medical Center[Active, Not Recruiting]Kumamoto, Japan, 860-0008 Nagasaki University HospitalNagasaki, Japan, 852-8501 Tokyo Medical University HospitalTokyo, Japan, 160-0023 Korea, Republic Of, Jeollabuk-Do Chonbuk National University HospitalJeonju-Si, Jeollabuk-Do, Korea, Republic Of, 54907 Korea, Republic Of, Jeollanam-Do Chonnam National University Hwasun HospitalHwasun-Gun, Jeollanam-Do, Korea, Republic Of, 58128 Korea, Republic Of Department Of Pharmacy, Inje University Busan Paik HospitalBusan, Korea, Republic Of, 47392 Inje University Busan Paik HospitalBusan, Korea, Republic Of, 47392 Clinical Trial Pharmacy, Keimyung University Dongsan HospitalDaegu, Korea, Republic Of, 41931 Keimyung University Dongsan HospitalDaegu, Korea, Republic Of, 41931 Gachon University Gil Medical CenterIncheon, Korea, Republic Of, 21565 Seoul National University HospitalSeoul, Korea, Republic Of, 03080 Severance Hospital, Yonsei University Health SystemSeoul, Korea, Republic Of, 03722 Department Of Pharmacy, Samsung Medical CenterSeoul, Korea, Republic Of, 06351 Samsung Medical CenterSeoul, Korea, Republic Of, 06351 The Catholic University Of Korea Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591 The Catholic University Of Korea, Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591|Yoshida-Gun, Fukui, Japan, 910-1193|Maebashi, Gunma, Japan, 371-8511|Kobe-Shi, Hyogo, Japan, 650-0017|Yokohama, Kanagawa, Japan, 232-0024|Sendai, Miyagi, Japan, 980-8574|Osaka-City, Osaka, Japan, 545-8586 Kindai University HospitalOsaka-Sayama, Osaka, Japan, 589-8511|Sunto-Gun, Shizuoka, Japan, 411-8777|Tachikawa, Tokyo, Japan, 190-0014|Gdansk, Poland, 80-214 Wwcoit Im. M. Kopernika W LodziLodz, Poland, 93-513|Cluj-Napoca, Cluj, Romania, 400124|Craiova, Dolj, Romania, 200136|Bucuresti, Romania, 010825 Spitalul Clinic Coltea, Clinica De HematologieBucuresti, Romania, 030171 Russian Federation Sbhi Cch No. 40 Hd MoscowMoscow, Russian Federation, 129301 State Budgetary Healthcare Institution Of MoscowMoscow, Russian Federation, 129301 Sbhi Nnr Nn Rch N. A. N.A. SemashkoNizhniy Novgorod, Russian Federation, 603126 State Budgetary Institution Of Ryazan Region 'Regional Clinical Hospital' (Sbi Rr Rch)Ryazan, Russian Federation, 390039 Fsbi Russrhti Fmba Of|Barcelona, Spain, 08003 Hospital De La Santa Creu I Sant PauBarcelona, Spain, 08025 Hospital Universitario Arnau De VilanovaLleida, Spain, 25198 Hospital General Universitario Gregorio MaranonMadrid, Spain, 28007 Hospital Universitario Ramon Y CajalMadrid, Spain, 28034 Hospital Universitario Virgen Del RocioSevilla, Spain, 41013 Hospital Universitari I Politecnic La FeValencia, Spain, 46026|Orebro, Sweden, 701 85 Universitetssjukhuset OrebroOrebro, Sweden, 701 85 Taiwan National Cheng Kung University HospitalTainan, Taiwan, 704 National Taiwan University HospitalTaipei, Taiwan, 100 Department Of Clinical Trial Pharmacy, Taipei Veterans General HospitalTaipei, Taiwan, 11217 Taipei Veterans General HospitalTaipei, Taiwan, 11217 Division Of Pharmacy, Koo Foundation Sun Yat-Sen Cancer CenterTaipei, Taiwan, 112 Koo Foundation Sun Yat-Sen Cancer CenterTaipei, Taiwan, 112 Chang Gung Memorial Hospital-Linkou BranchTaoyuan City, Taiwan, 333 Chemotherapy Pharmacy, Chang Gung Memorial Hospital-Linkou BranchTaoyuan City, Taiwan, 333|Sutton, Surrey, United Kingdom, Sm2 5Pt|London, United Kingdom, Ec1A 7Be Imperial College Healthcare Nhs TrustLondon, United Kingdom, W12 0Hs|Los Angeles, California, United States, 90033 Lac+Usc Medical CenterLos Angeles, California, United States, 90033 Usc/Norris Comprehensive Cancer Center / Investigational Drug ServicesLos Angeles, California, United States, 90033 Usc/Norris Comprehensive Cancer CenterLos Angeles, California, United States, 90033 Rrmc - UclaLos Angeles, California, United States, 90095 Ucla Department Of MedicineLos Angeles, California, United States, 90095 Ucla Hematology/Oncology ClinicLos Angeles, California, United States, 90095 Ucla Ronald Reagan Medical CenterLos Angeles, California, United States, 90095 Keck Medicine Of Usc Norris Oncology/Hematology - Newport Beach Treatment CenterNewport Beach, California, United States, 92663 Usc Norris Oncology/Hematology - Newport BeachNewport Beach, California, United States, 92663 Uc Irvine Health - Chao Family Comprehensive Cancer CenterOrange, California, United States, 92868-3201 Uc Irvine Medical CenterOrange, California, United States, 92868-3201 Ucsf Helen Diller Family Comprehensive Cancer CenterSan Francisco, California, United States, 94143 University Of California, San Francisco Medical CenterSan Francisco, California, United States, 94143 University Of California, San FranciscoSan Francisco, California, United States, 94143|Boston, Massachusetts, United States, 02111|Kansas City, Missouri, United States, 64132|Lake Success, New York, United States, 11042 North Shore University HospitalManhasset, New York, United States, 11030 Long Island Jewish Medical CenterNew Hyde Park, New York, United States, 11040 University Of Rochester Cancer Center PharmacyRochester, New York, United States, 14642 University Of Rochester Medical CenterRochester, New York, United States, 14642|Cleveland, Ohio, United States, 44106 University Hospitals Cleveland Medical CenterCleveland, Ohio, United States, 44106 Cleveland Clinic FoundationCleveland, Ohio, United States, 44195|Nashville, Tennessee, United States, 37203|Dallas, Texas, United States, 75246 Baylor University Medical CenterDallas, Texas, United States, 75246 Blood Cancer And Stem Cell Transplant ClinicSan Antonio, Texas, United States, 78229 Methodist Healthcare System Of San AntonioSan Antonio, Texas, United States, 78229 Methodist Hospital Investigational PharmacySan Antonio, Texas, United States, 78229|Seattle, Washington, United States, 98104 Swedish Investigational Drug Services PharmacySeattle, Washington, United States, 98104 Swedish Medical CenterSeattle, Washington, United States, 98122","California|Massachusetts|Missouri|New York|Ohio|Tennessee|Texas|Washington","Australia|Austria|Canada|Czechia|France|Hungary|Italy|Japan|Poland|Romania|Spain|Sweden|United Kingdom|United States","Australia, 5000 Royal Adelaide Hospital|New South Wales St Vincent's Hospital Sydney|Royal Adelaide Hospital - Clinical Trials Pharmacy|Landeskrankenhaus Salzburg, Universitaetsklinik Fuer Innere Medizin Iii Der Pmu|Manitoba Cancercare Manitoba|Interni Hematologicka A Onkologicka Klinika, Fakultni Nemocnice Brno|Chu Henri Mondor|Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Klinika, Hematologia Tanszek|An Aou Ospedali Riuniti Umberto I, G.M. Lancisi, G. Salesi, Clinica Di Ematologia|Fe A.O.U. Di Ferrara- Arcispedale Sant'Anna,|Pu Ao Ospedali Riuniti Marche Nord - Presidio Ospedaliero San Salvatore Di Pesaro -|Aichi Japanese Red Cross Nagoya Daini Hospital|Akita University Hospital|Fukui University Of Fukui Hospital|Gunma Gunma University Hospital|Hyogo Kobe University Hospital|Kanagawa Yokohama City University Medical Center|Miyagi Tohoku University Hospital|Osaka Osaka City University Hospital|Shizuoka Shizuoka Cancer Center|Tokyo National Hospital Organization Disaster Medical Center|Klinika Hematologii I Transplantologii Uniwersyteckie Centrum Kliniczne|Cluj Institutul Oncologic 'Prof. Dr. Ion Chiricuta'|Dolj Spitalul Clinic Municipal Filantropia Craiova, Sectia Clinica Hematologie|Spitalul Universitar De Urgenta Militar Central \"Dr. Carol Davila\" Bucuresti|Hospital Del Mar|Apoex Vn|, Surrey The Royal Marsden Nhs Foundation Trust|Barts Health Nhs Trust|Keck Hospital Of Usc|Tufts Medical Center|Midamerica Division, Inc., C/O Research Medical Center|Northwell Health/Monter Cancer Center|Taussig Cancer Center Investigational Pharmacy|The Sarah Cannon Research Institute|Baylor Scott And White Research Institute|Swedish Cancer Institute",{"$nulls":3},"Pfizer CT.gov Call Center","2019-03-03","2020-05-25T16:39:33.662","2020-05-26T17:10:42.972","NCT03416179"]
["5ecbf4c6307e3d1b1f8d9e4c","NCT03416179","2019-03-13","Pfizer","PFE","Recruiting","A Study Evaluating Intensive Chemotherapy With or Without Glasdegib or Azacitidine With or Without Glasdegib In Patients With Previously Untreated Acute Myeloid Leukemia (BRIGHT AML1019)","Glasdegib|Cytarabine|Daunorubicin|Azacitidine","Hh Inhibitor|DNA Polymerase Inhibitor|Nucleic Acid Synthesis Inhibitor|TOP2 Inhibitor|DNA Mtase Inhibitor","Unknown",null,"Unknown",null,"Phase 3",4,720,"Anticipated","2018-04-20","2021-06-13","OS","Overall Survival",{"$nulls":3},"Glasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).\n\nGlasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).","Two separate registration trials conducted under one protocol number are proposed to adequately and independently evaluate the addition of glasdegib in intensive and non-intensive chemotherapy populations. Each study will have an experimental treatment arm and a placebo arm. Endpoints are the same for each study except where specifically indicated.\n\nAssignment to the Intensive Study or the Non-Intensive Study will be made by the Investigator based on the 2017 European LeukemiaNet (ELN) recommendations.\n\nStudy B1371019 is a randomized (1:1), double-blind, multi-center, placebo controlled study of chemotherapy in combination with glasdegib versus chemotherapy in combination with placebo in adult patients with previously untreated AML.\n\nGlasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).\n\nGlasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).","A RANDOMIZED (1:1), DOUBLE-BLIND, MULTI-CENTER, PLACEBO CONTROLLED STUDY EVALUATING INTENSIVE CHEMOTHERAPY WITH OR WITHOUT GLASDEGIB (PF-04449913) OR AZACITIDINE (AZA) WITH OR WITHOUT GLASDEGIB IN PATIENTS WITH PREVIOUSLY UNTREATED ACUTE MYELOID LEUKEMIA","B1371019","Leukemia, Myeloid, Acute","Acute Leukemia|Acute Myeloid Leukemia|Myeloid Leukemia|Leukemia","Oncology Hematological","Oncology","Experimental|Placebo Comparator","Arm A (Intensive Study)|Arm B (Intensive Study)|Arm A (Non-intensive study)|Arm B (Non-intensive study)","Glasdegib + '7+3' Induction(s)|Placebo + '7+3' Induction(s)|Glasdegib + azacitidine|Placebo + azacitidine","Drug|Procedure","glasdegib|daunorubicin + cytarabine|cytarabine|HSCT|Placebo|azacitidine","Daily Glasdegib (100 mg, PO), beginning on Day 1 and is to continue up to 2 years post randomization.\n\nFollowing consolidation therapy, glasdegib or placebo will be administered daily for up to 2 years after randomization or until they have minimal residual disease (MRD) negative disease, whichever comes first.\n\nDaily Glasdegib (100 mg, PO) or matching placebo will continue throughout Induction(s) and Consolidation therapies regardless of dose modifications/delays in the chemotherapy.|Consolidation with single agent cytarabine 3 g/m2 IV for adults <60 years and 1 g/m2 for adults 60 years over 3 BID on Days 1, 3, and 5, every 28 days for up to 4 cycles or alternative single agent cytarabine consolidation schedules may be used per local prescribing information.|If required, and done per standard of care post Induction(s).|Azacitidine (75 mg/m2, SC or IV) daily for 7 days, in 28 day cycles for as long as they do not meet the criteria for disease progression, unacceptable toxicity, consent withdrawal, or death.|Matching placebo (PO) is to be administered by mouth daily beginning on Day 1 of chemotherapy and will continue if subjects demonstrate reasonable evidence of clinical benefit and do not meet the criteria for progression regardless of any delays/modifications in the chemotherapy treatment. Subjects will continue placebo until disease progression, unacceptable toxicity, consent withdrawal, or death, whichever comes first.","PF-04449913","Arm A (Intensive Study)|Arm B (Intensive Study)|Arm A (Non-intensive study)|Arm B (Non-intensive study)","\n\nSubjects must meet all of the following inclusion criteria to be eligible for enrollment into the Intensive and Non Intensive study (unless where indicated):\n\n 1.  Subjects with untreated AML according to the World Health Organization (WHO) 2016 Classification2, including those with: * AML arising from MDS or another antecedent hematologic disease (AHD).\n      * AML after previous cytotoxic therapy or radiation (secondary AML).\n     \n     \n 2.  18 years of age (In Japan, 20 years of age).\n 3.  Adequate Organ Function as defined by the following: * Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) 3 x upper limit of normal (ULN), excluding subjects with liver function abnormalities due to underlying malignancy.\n      * Total serum bilirubin 2 x ULN (except subjects with documented Gilbert's syndrome).\n      * Estimated creatinine clearance 30 mL/min as calculated using the standard method for the institution.\n     \n     \n 4.  QTc interval 470 msec using the Fridericia correction (QTcF).\n 5.  All anti cancer treatments (unless specified) should be discontinued 2 weeks from study entry, for example: targeted chemotherapy, radiotherapy, investigational agents, hormones, anagrelide or cytokines. * For control of rapidly progressing leukemia, all trans retinoic acid (ATRA), hydroxyurea, and/or leukopheresis may be used before and for up to 1 week after the first dose of glasdegib.\n     \n     \n 6.  Serum or urine pregnancy test (for female subjects of childbearing potential) with a minimum sensitivity of 25 IU/L or equivalent units of human chorionic gonadotropin (hCG) negative at screening.\n 7.  Male and female subjects of childbearing potential and at risk for pregnancy must agree to use at least one highly effective method of contraception throughout the study and for 180 days after the last dose of azacitidine, cytarabine, or daunorubicin; and the last dose of glasdegib or placebo, whichever occurs later.\n 8.  Female subjects of non childbearing potential must meet at least 1 of the following criteria: 1. Have undergone a documented hysterectomy and/or bilateral oophorectomy;\n      2. Have medically confirmed ovarian failure; or\n      3. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; status may be confirmed by having a serum follicle stimulating hormone (FSH) level confirming the postmenopausal state.\n     \n     All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential.\n     \n     \n 9.  Consent to a saliva sample collection for a germline comparator, unless prohibited by local regulations or ethics committee (EC) decision.\n 10. Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.\n 11. Subjects who are willing and able to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures (including bone marrow [BM] assessments).\n\n","\n\nSubjects with any of the following characteristics/conditions will not be included in the study:\n\n 1.  Acute Promyelocytic Leukemia (APL) and APLwith PML RARA, subjects (WHO 2016 classification).\n 2.  AML with BCR ABL1 or t(9;22)(q34;q11.2) as a sole abnormality. * Complex genetics may include t(9;22) cytogenetic translocation.\n     \n     \n 3.  Subjects with known active CNS leukemia.\n 4.  Participation in other clinical studies involving other investigational drug(s) (Phases 1 4) within 4 weeks prior study entry and/or during study participation.\n 5.  Subjects known to be refractory to platelet or packed red cell transfusions per Institutional Guidelines, or a patient who refuses blood product support.\n 6.  Subjects with another active malignancy on treatment with the exception of basal cell carcinoma, non melanoma skin cancer, cervical carcinoma in situ. Other prior or concurrent malignancies will be considered on a case by case basis.\n 7.  Any one of the following ongoing or in the previous 6 months: myocardial infarction, congenital long QT syndrome, Torsades de pointes, symptomatic arrhythmias (including sustained ventricular tachyarrhythmia), right or left bundle branch block and bifascicular block, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (CHF New York Heart Association class III or IV), cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism; as well as bradycardia defined as <50 bpms.\n 8.  Subjects with an active, life threatening or clinically significant uncontrolled systemic infection not related to AML.\n 9.  Subjects with left ventricular ejection fraction (LVEF) <50% are excluded from the Intensive Chemotherapy Study only.\n 10. Cumulative anthracycline dose equivalent of 550 mg/m2 of daunorubicin for the Intensive Chemotherapy Study only.\n 11. Known malabsorption syndrome or other condition that may significantly impair absorption of study medication in the investigator's judgment (eg, gastrectomy, lap band, Crohn's disease) and inability or unwillingness to swallow tablets or capsules.\n 12. Current use or anticipated requirement for drugs that are known strong CYP3A4/5 inducers.\n 13. Concurrent administration of herbal preparations.\n 14. Major surgery or radiation within 4 weeks of starting study treatment.\n 15. Documented or suspected hypersensitivity to any one of the following: * For subjects assigned to intensive chemotherapy, documented or suspected hypersensitivity to cytarabine (not including drug fever or exanthema, including known cerebellar side effects) or daunorubicin.\n      * For subjects assigned to non intensive chemotherapy, documented or suspected hypersensitivity to azacitidine or mannitol.\n     \n     \n 16. Known active drug or alcohol abuse.\n 17. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.\n 18. Pregnant females or breastfeeding female subjects.\n 19. Known recent or active suicidal ideation or behavior.\n 20. Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.","FSH",null,"Protein","Ovary","Actual","2018-01-31","Actual","Anticipated","2025-07-22","Anticipated","2019-03-01","2017-12-21","2018-01-23","2019-03-11","Yes","glasdegib;\nuntreated;\nHedgehog Inhibitor","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"All",null,"No","Yes\nPfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",null,"URL: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1371019&StudyName=A+Randomized+%281%3A1%29%2C+Double+Blind%2C+Multi+Center%2C+Placebo+Controlled+Study+Evaluating+Intensive+Chemotherapy+With+Or+Without+Glasdegib+%28pf+04449913%29+Or+Azacitidine+%28aza%29+With+Or+Without+Glasdegib+In+Patients+With+Previously+Untreated+Acute+Myeloid+Leukemia [https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1371019&StudyName=A+Randomized+%281%3A1%29%2C+Double+Blind%2C+Multi+Center%2C+Placebo+Controlled+Study+Evaluating+Intensive+Chemotherapy+With+Or+Without+Glasdegib+%28pf+04449913%29+Or+Azacitidine+%28aza%29+With+Or+Without+Glasdegib+In+Patients+With+Previously+Untreated+Acute+Myeloid+Leukemia] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To obtain contact information for a study center near you, click here.",null,"Yes","No",{"$nulls":17},"2017-002822-19|BRIGHT|BRIGHT AML1019","EudraCT Number|Alias Study Number","Overall survival","5 years after last subject randomized",null,"Fatigue score measured by the MD Anderson Symptom Inventory (MDASI)-AML/MDS questionnaire|Rate of Complete Remission (CR) (including CR with minimal residual disease (MRD)-negative as assessed by multiparametric flow cytometry)|Duration of response (defined as CR [includes CR-MRD negative]/CRi or CR/CRh as appropriate)|Time to response (CR[includes CR-MRD negative)]/CR with partial hematologic rcovery (CRh) as appropriate)|Event-free Survival|Patient Reported Outcomes (PROs) as measured by the M.D. Anderson Symptom Inventory AML/MDS Module (MDASI-AML/MDS)|Adverse events as graded by NCI CTCAE v4.03|Laboratory abnormalities as graded by NCI CTCAE v4.03|For the intensive study, the plasma trough concentration (Ctrough) will be analyzed|QTc interval|PROs as measured by Patient Global Impression of Change (PGIC)|Patient Reported Outcomes (PROs) as measured by EuroQoL 5 Dimension questionnaire 5-Level version (EQ-5D-5L)|Patient Reported Outcomes (PROs) as measured by Patient Global Impression of Symptoms (PGIS)|Complete Remission with incomplete hematologic recovery (CRi)|Rate of morphological leukemia-free state (MLFS)|Rate of Partial Remission (PR)|Rate of Complete Remission with partial hematological recovery (CRh) for the Non-intensive study only only|Minimum Observed Plasma Trough Concentratrion of glasdegib in the Intensive Study|Minimum Observed Plasma Trough Concentration of glasdegib in the Non-intensive study","Scale is from 0-10 where 0 is not present and 10 is as bad as you can image.|Response as defined by the 2017 European LeukemiaNet (ELN) recommendations.|5 years after last subject randomized, consent withdrawal, or death|Measurement Scale from 0-10.|PK samples taken on Induction(s) Day 1 (1 and 4 hours post induction); Induction(s) Day 10 (pre-dose, 1 and 4 hours post dose); Day 1 of each Consolidation cycle (pre-dose, 1 and 4 hours post dose)|One question asking for description of leukemia symptoms.|Series of questions that ask for information that best describes health.|One question asking for information regarding leukemia symptoms.|Its the minimum trough concentration in plasma of glasdegib following multiple daily dosing to steady state.|It is the minimum trough concentration in plasma of glasdegib following multiple daily dosing to steady state.","5 years after last subject randomized, consent withdrawal, or death|2 years after last dose of study therapy|5 years after last patient randomized, withdrawal, or death|5 years after last subject randomized, withdrawal, or death|Day 10 of Induction Cycle and Day 1 of each Consolidation Cycle|Cycle 1 Day 15 and Cycles 2 and 3 on Day 1","ClinicalTrials.gov_Inquiries@pfizer.com","Pfizer CT.gov Call Center","1-800-718-1021","Adelaide, South|Darlinghurst, New South Wales, Australia, 2010 St George HospitalKogarah, New South Wales, Australia, 2217|Salzburg, Austria, 5020 Uniklinikum Salzburg, Landeskrankenhaus Salzburg,Salzburg, Austria, 5020 Sozialmedizinisches Zentrum Sud.Wien, Austria, 1100 Krankenhaus Hietzing Mit Neurologischem Zentrum RosenhugelWien, Austria, I130|Leuven, Belgium, B-3000|Winnipeg, Manitoba, Canada, R3E 0V9|Toronto, Ontario, Canada, M5G 2M9|Montreal, Quebec, Canada, H1T 2M4|Brno, Czechia, 100 34 Nemocnicni LekarnaBrno, Czechia, 625 00 InternÃ­ HematologickÃ¡ Klinika, Fakultni Nemocnice KrÃ¡lovskÃ© VinohradyPraha 10, Czechia, 100 34 Ãšstavni LÃ©kÃ¡rnaPraha 10, Czechia, 100 34|Creteil, France, 94010 Chu Henri MondorCrÃ©teil, France, 94010 Chu De NantesNantes Cedex 1, France, 44093 Chu De Nantes Hotel DieuNantes Cedex, France, 44093 Hopital Saint LouisParis, France, 75010 Centre Hospitalier Lyon Sud -Unite De Pharmacie Clinique OncologiquePierre Benite Cedex, France, 69495 Centre Hospitalier Lyon Sud - Service D'HematologiePierre Benite Cedex, France, 69495|Debrecen, Hungary, 4032 Debreceni Egyetem Klinikai Kozpont Belgyogyaszati KlinikaDebrecen, Hungary, 4032 Petz AladÃ¡r Megyei OktatÃ³ KÃ³rhÃ¡z, GyÃ³gyszerÃ©szeti OsztÃ¡lyGyÅ‘r, Hungary, 9024 Petz AladÃ¡r Megyei OktatÃ³ KÃ³rhÃ¡z, Ii. BelgyÃ³gyÃ¡szat- HematolÃ³giai OsztÃ¡lyGyÅ‘r, Hungary, 9024|Jerusalem, Israel, 91120|Ancona, An, Italy, 60126 Sod Farmacia-Dipt Dei Servizi -Aou Ospedali Riuniti Umberto I, G.M. Lancisi, G. SalesiTorette Di Ancona, An, Italy, 60126|Cona, Ferrara, Fe, Italy, 44124 Farmacia OspedalieraFerrara, Fe, Italy, 44121|Pesaro, Pu, Italy, 61122|Nagoya, Aichi, Japan, 466-8650|Akita, Japan, 010-8543 Kyushu University HospitalFukuoka, Japan, 812-8582 National Hospital Organization Kumamoto Medical Center[Active, Not Recruiting]Kumamoto, Japan, 860-0008 Nagasaki University HospitalNagasaki, Japan, 852-8501 Tokyo Medical University HospitalTokyo, Japan, 160-0023 Korea, Republic Of, Jeollabuk-Do Chonbuk National University HospitalJeonju-Si, Jeollabuk-Do, Korea, Republic Of, 54907 Korea, Republic Of, Jeollanam-Do Chonnam National University Hwasun HospitalHwasun-Gun, Jeollanam-Do, Korea, Republic Of, 58128 Korea, Republic Of Department Of Pharmacy, Inje University Busan Paik HospitalBusan, Korea, Republic Of, 47392 Inje University Busan Paik HospitalBusan, Korea, Republic Of, 47392 Clinical Trial Pharmacy, Keimyung University Dongsan HospitalDaegu, Korea, Republic Of, 41931 Keimyung University Dongsan HospitalDaegu, Korea, Republic Of, 41931 Gachon University Gil Medical CenterIncheon, Korea, Republic Of, 21565 Seoul National University HospitalSeoul, Korea, Republic Of, 03080 Severance Hospital, Yonsei University Health SystemSeoul, Korea, Republic Of, 03722 Department Of Pharmacy, Samsung Medical CenterSeoul, Korea, Republic Of, 06351 Samsung Medical CenterSeoul, Korea, Republic Of, 06351 The Catholic University Of Korea Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591 The Catholic University Of Korea, Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591|Yoshida-Gun, Fukui, Japan, 910-1193|Maebashi, Gunma, Japan, 371-8511|Kobe-Shi, Hyogo, Japan, 650-0017|Yokohama, Kanagawa, Japan, 232-0024|Sendai, Miyagi, Japan, 980-8574|Osaka-City, Osaka, Japan, 545-8586 Kindai University HospitalOsaka-Sayama, Osaka, Japan, 589-8511|Sunto-Gun, Shizuoka, Japan, 411-8777|Tachikawa, Tokyo, Japan, 190-0014|Gdansk, Poland, 80-214 Wwcoit Im. M. Kopernika W LodziLodz, Poland, 93-513|Cluj-Napoca, Cluj, Romania, 400124|Craiova, Dolj, Romania, 200136|Bucuresti, Romania, 010825 Spitalul Clinic Coltea, Clinica De HematologieBucuresti, Romania, 030171 Russian Federation Sbhi Cch No. 40 Hd MoscowMoscow, Russian Federation, 129301 State Budgetary Healthcare Institution Of MoscowMoscow, Russian Federation, 129301 Sbhi Nnr Nn Rch N. A. N.A. SemashkoNizhniy Novgorod, Russian Federation, 603126 State Budgetary Institution Of Ryazan Region 'Regional Clinical Hospital' (Sbi Rr Rch)Ryazan, Russian Federation, 390039 Fsbi Russrhti Fmba Of|Barcelona, Spain, 08003 Hospital De La Santa Creu I Sant PauBarcelona, Spain, 08025 Hospital Universitario Arnau De VilanovaLleida, Spain, 25198 Hospital General Universitario Gregorio MaranonMadrid, Spain, 28007 Hospital Universitario Ramon Y CajalMadrid, Spain, 28034 Hospital Universitario Virgen Del RocioSevilla, Spain, 41013 Hospital Universitari I Politecnic La FeValencia, Spain, 46026|Orebro, Sweden, 701 85 Universitetssjukhuset OrebroOrebro, Sweden, 701 85 Taiwan National Cheng Kung University HospitalTainan, Taiwan, 704 National Taiwan University HospitalTaipei, Taiwan, 100 Department Of Clinical Trial Pharmacy, Taipei Veterans General HospitalTaipei, Taiwan, 11217 Taipei Veterans General HospitalTaipei, Taiwan, 11217 Division Of Pharmacy, Koo Foundation Sun Yat-Sen Cancer CenterTaipei, Taiwan, 112 Koo Foundation Sun Yat-Sen Cancer CenterTaipei, Taiwan, 112 Chang Gung Memorial Hospital-Linkou BranchTaoyuan City, Taiwan, 333 Chemotherapy Pharmacy, Chang Gung Memorial Hospital-Linkou BranchTaoyuan City, Taiwan, 333|Sutton, Surrey, United Kingdom, Sm2 5Pt|London, United Kingdom, Ec1A 7Be Imperial College Healthcare Nhs TrustLondon, United Kingdom, W12 0Hs|Los Angeles, California, United States, 90033 Lac+Usc Medical CenterLos Angeles, California, United States, 90033 Usc/Norris Comprehensive Cancer Center / Investigational Drug ServicesLos Angeles, California, United States, 90033 Usc/Norris Comprehensive Cancer CenterLos Angeles, California, United States, 90033 Rrmc - UclaLos Angeles, California, United States, 90095 Ucla Department Of MedicineLos Angeles, California, United States, 90095 Ucla Hematology/Oncology ClinicLos Angeles, California, United States, 90095 Ucla Ronald Reagan Medical CenterLos Angeles, California, United States, 90095 Keck Medicine Of Usc Norris Oncology/Hematology - Newport Beach Treatment CenterNewport Beach, California, United States, 92663 Usc Norris Oncology/Hematology - Newport BeachNewport Beach, California, United States, 92663 Uc Irvine Health - Chao Family Comprehensive Cancer CenterOrange, California, United States, 92868-3201 Uc Irvine Medical CenterOrange, California, United States, 92868-3201 Ucsf Helen Diller Family Comprehensive Cancer CenterSan Francisco, California, United States, 94143 University Of California, San Francisco Medical CenterSan Francisco, California, United States, 94143 University Of California, San FranciscoSan Francisco, California, United States, 94143|Boston, Massachusetts, United States, 02111|Kansas City, Missouri, United States, 64132|Lake Success, New York, United States, 11042 North Shore University HospitalManhasset, New York, United States, 11030 Long Island Jewish Medical CenterNew Hyde Park, New York, United States, 11040 University Of Rochester Cancer Center PharmacyRochester, New York, United States, 14642 University Of Rochester Medical CenterRochester, New York, United States, 14642|Cleveland, Ohio, United States, 44106 University Hospitals Cleveland Medical CenterCleveland, Ohio, United States, 44106 Cleveland Clinic FoundationCleveland, Ohio, United States, 44195|Nashville, Tennessee, United States, 37203|Dallas, Texas, United States, 75246 Baylor University Medical CenterDallas, Texas, United States, 75246 Blood Cancer And Stem Cell Transplant ClinicSan Antonio, Texas, United States, 78229 Methodist Healthcare System Of San AntonioSan Antonio, Texas, United States, 78229 Methodist Hospital Investigational PharmacySan Antonio, Texas, United States, 78229|Seattle, Washington, United States, 98104 Swedish Investigational Drug Services PharmacySeattle, Washington, United States, 98104 Swedish Medical CenterSeattle, Washington, United States, 98122","California|Massachusetts|Missouri|New York|Ohio|Tennessee|Texas|Washington","Australia|Austria|Belgium|Canada|Czechia|France|Hungary|Israel|Italy|Japan|Poland|Romania|Spain|Sweden|United Kingdom|United States","Australia, 5000 Royal Adelaide Hospital|New South Wales St Vincent's Hospital Sydney|Royal Adelaide Hospital - Clinical Trials Pharmacy|Landeskrankenhaus Salzburg, Universitaetsklinik Fuer Innere Medizin Iii Der Pmu|Universitaire Ziekenhuizen Leuven|Manitoba Cancercare Manitoba|Ontario Princess Margaret Cancer Centre|Quebec Ciusss De L'Est-De-L'Ile-De- MontrÃ©al - HÃ´pital Maisonneuve-Rosemont|Interni Hematologicka A Onkologicka Klinika, Fakultni Nemocnice Brno|Chu Henri Mondor|Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Klinika, Hematologia Tanszek|Hadassah Medical Center (Ein Kerem)|An Aou Ospedali Riuniti Umberto I, G.M. Lancisi, G. Salesi, Clinica Di Ematologia|Fe A.O.U. Di Ferrara- Arcispedale Sant'Anna,|Pu Ao Ospedali Riuniti Marche Nord - Presidio Ospedaliero San Salvatore Di Pesaro -|Aichi Japanese Red Cross Nagoya Daini Hospital|Akita University Hospital|Fukui University Of Fukui Hospital|Gunma Gunma University Hospital|Hyogo Kobe University Hospital|Kanagawa Yokohama City University Medical Center|Miyagi Tohoku University Hospital|Osaka Osaka City University Hospital|Shizuoka Shizuoka Cancer Center|Tokyo National Hospital Organization Disaster Medical Center|Klinika Hematologii I Transplantologii Uniwersyteckie Centrum Kliniczne|Cluj Institutul Oncologic 'Prof. Dr. Ion Chiricuta'|Dolj Spitalul Clinic Municipal Filantropia Craiova, Sectia Clinica Hematologie|Spitalul Universitar De Urgenta Militar Central \"Dr. Carol Davila\" Bucuresti|Hospital Del Mar|Apoex Vn|, Surrey The Royal Marsden Nhs Foundation Trust|Barts Health Nhs Trust|Keck Hospital Of Usc|Tufts Medical Center|Midamerica Division, Inc., C/O Research Medical Center|Northwell Health/Monter Cancer Center|Taussig Cancer Center Investigational Pharmacy|The Sarah Cannon Research Institute|Baylor Scott And White Research Institute|Swedish Cancer Institute",{"$nulls":3},"Pfizer CT.gov Call Center","2019-03-11","2020-05-25T16:39:34.085","2020-05-26T17:10:42.972","NCT03416179"]
["5ecbf4c6fe30261b1a0483bc","NCT03416179","2019-04-01","Pfizer","PFE","Recruiting","A Study Evaluating Intensive Chemotherapy With or Without Glasdegib or Azacitidine With or Without Glasdegib In Patients With Previously Untreated Acute Myeloid Leukemia (BRIGHT AML1019)","Glasdegib|Cytarabine|Daunorubicin|Azacitidine","Hh Inhibitor|DNA Polymerase Inhibitor|Nucleic Acid Synthesis Inhibitor|TOP2 Inhibitor|DNA Mtase Inhibitor","Unknown",null,"Unknown",null,"Phase 3",4,720,"Anticipated","2018-04-20","2021-06-13","OS","Overall Survival",{"$nulls":3},"Glasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).\n\nGlasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).","Two separate registration trials conducted under one protocol number are proposed to adequately and independently evaluate the addition of glasdegib in intensive and non-intensive chemotherapy populations. Each study will have an experimental treatment arm and a placebo arm. Endpoints are the same for each study except where specifically indicated.\n\nAssignment to the Intensive Study or the Non-Intensive Study will be made by the Investigator based on the 2017 European LeukemiaNet (ELN) recommendations.\n\nStudy B1371019 is a randomized (1:1), double-blind, multi-center, placebo controlled study of chemotherapy in combination with glasdegib versus chemotherapy in combination with placebo in adult patients with previously untreated AML.\n\nGlasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).\n\nGlasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).","A RANDOMIZED (1:1), DOUBLE-BLIND, MULTI-CENTER, PLACEBO CONTROLLED STUDY EVALUATING INTENSIVE CHEMOTHERAPY WITH OR WITHOUT GLASDEGIB (PF-04449913) OR AZACITIDINE (AZA) WITH OR WITHOUT GLASDEGIB IN PATIENTS WITH PREVIOUSLY UNTREATED ACUTE MYELOID LEUKEMIA","B1371019","Leukemia, Myeloid, Acute","Acute Leukemia|Acute Myeloid Leukemia|Myeloid Leukemia|Leukemia","Oncology Hematological","Oncology","Experimental|Placebo Comparator","Arm A (Intensive Study)|Arm B (Intensive Study)|Arm A (Non-intensive study)|Arm B (Non-intensive study)","Glasdegib + '7+3' Induction(s)|Placebo + '7+3' Induction(s)|Glasdegib + azacitidine|Placebo + azacitidine","Drug|Procedure","glasdegib|daunorubicin + cytarabine|cytarabine|HSCT|Placebo|azacitidine","Daily Glasdegib (100 mg, PO), beginning on Day 1 and is to continue up to 2 years post randomization.\n\nFollowing consolidation therapy, glasdegib or placebo will be administered daily for up to 2 years after randomization or until they have minimal residual disease (MRD) negative disease, whichever comes first.\n\nDaily Glasdegib (100 mg, PO) or matching placebo will continue throughout Induction(s) and Consolidation therapies regardless of dose modifications/delays in the chemotherapy.|Consolidation with single agent cytarabine 3 g/m2 IV for adults <60 years and 1 g/m2 for adults 60 years over 3 BID on Days 1, 3, and 5, every 28 days for up to 4 cycles or alternative single agent cytarabine consolidation schedules may be used per local prescribing information.|If required, and done per standard of care post Induction(s).|Azacitidine (75 mg/m2, SC or IV) daily for 7 days, in 28 day cycles for as long as they do not meet the criteria for disease progression, unacceptable toxicity, consent withdrawal, or death.|Matching placebo (PO) is to be administered by mouth daily beginning on Day 1 of chemotherapy and will continue if subjects demonstrate reasonable evidence of clinical benefit and do not meet the criteria for progression regardless of any delays/modifications in the chemotherapy treatment. Subjects will continue placebo until disease progression, unacceptable toxicity, consent withdrawal, or death, whichever comes first.","PF-04449913","Arm A (Intensive Study)|Arm B (Intensive Study)|Arm A (Non-intensive study)|Arm B (Non-intensive study)","\n\nSubjects must meet all of the following inclusion criteria to be eligible for enrollment into the Intensive and Non Intensive study (unless where indicated):\n\n 1.  Subjects with untreated AML according to the World Health Organization (WHO) 2016 Classification2, including those with: * AML arising from MDS or another antecedent hematologic disease (AHD).\n      * AML after previous cytotoxic therapy or radiation (secondary AML).\n     \n     \n 2.  18 years of age (In Japan, 20 years of age).\n 3.  Adequate Organ Function as defined by the following: * Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) 3 x upper limit of normal (ULN), excluding subjects with liver function abnormalities due to underlying malignancy.\n      * Total serum bilirubin 2 x ULN (except subjects with documented Gilbert's syndrome).\n      * Estimated creatinine clearance 30 mL/min as calculated using the standard method for the institution.\n     \n     \n 4.  QTc interval 470 msec using the Fridericia correction (QTcF).\n 5.  All anti cancer treatments (unless specified) should be discontinued 2 weeks from study entry, for example: targeted chemotherapy, radiotherapy, investigational agents, hormones, anagrelide or cytokines. * For control of rapidly progressing leukemia, all trans retinoic acid (ATRA), hydroxyurea, and/or leukopheresis may be used before and for up to 1 week after the first dose of glasdegib.\n     \n     \n 6.  Serum or urine pregnancy test (for female subjects of childbearing potential) with a minimum sensitivity of 25 IU/L or equivalent units of human chorionic gonadotropin (hCG) negative at screening.\n 7.  Male and female subjects of childbearing potential and at risk for pregnancy must agree to use at least one highly effective method of contraception throughout the study and for 180 days after the last dose of azacitidine, cytarabine, or daunorubicin; and the last dose of glasdegib or placebo, whichever occurs later.\n 8.  Female subjects of non childbearing potential must meet at least 1 of the following criteria: 1. Have undergone a documented hysterectomy and/or bilateral oophorectomy;\n      2. Have medically confirmed ovarian failure; or\n      3. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; status may be confirmed by having a serum follicle stimulating hormone (FSH) level confirming the postmenopausal state.\n     \n     All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential.\n     \n     \n 9.  Consent to a saliva sample collection for a germline comparator, unless prohibited by local regulations or ethics committee (EC) decision.\n 10. Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.\n 11. Subjects who are willing and able to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures (including bone marrow [BM] assessments).\n\n","\n\nSubjects with any of the following characteristics/conditions will not be included in the study:\n\n 1.  Acute Promyelocytic Leukemia (APL) and APLwith PML RARA, subjects (WHO 2016 classification).\n 2.  AML with BCR ABL1 or t(9;22)(q34;q11.2) as a sole abnormality. * Complex genetics may include t(9;22) cytogenetic translocation.\n     \n     \n 3.  Subjects with known active CNS leukemia.\n 4.  Participation in other clinical studies involving other investigational drug(s) (Phases 1 4) within 4 weeks prior study entry and/or during study participation.\n 5.  Subjects known to be refractory to platelet or packed red cell transfusions per Institutional Guidelines, or a patient who refuses blood product support.\n 6.  Subjects with another active malignancy on treatment with the exception of basal cell carcinoma, non melanoma skin cancer, cervical carcinoma in situ. Other prior or concurrent malignancies will be considered on a case by case basis.\n 7.  Any one of the following ongoing or in the previous 6 months: myocardial infarction, congenital long QT syndrome, Torsades de pointes, symptomatic arrhythmias (including sustained ventricular tachyarrhythmia), right or left bundle branch block and bifascicular block, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (CHF New York Heart Association class III or IV), cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism; as well as bradycardia defined as <50 bpms.\n 8.  Subjects with an active, life threatening or clinically significant uncontrolled systemic infection not related to AML.\n 9.  Subjects with left ventricular ejection fraction (LVEF) <50% are excluded from the Intensive Chemotherapy Study only.\n 10. Cumulative anthracycline dose equivalent of 550 mg/m2 of daunorubicin for the Intensive Chemotherapy Study only.\n 11. Known malabsorption syndrome or other condition that may significantly impair absorption of study medication in the investigator's judgment (eg, gastrectomy, lap band, Crohn's disease) and inability or unwillingness to swallow tablets or capsules.\n 12. Current use or anticipated requirement for drugs that are known strong CYP3A4/5 inducers.\n 13. Concurrent administration of herbal preparations.\n 14. Major surgery or radiation within 4 weeks of starting study treatment.\n 15. Documented or suspected hypersensitivity to any one of the following: * For subjects assigned to intensive chemotherapy, documented or suspected hypersensitivity to cytarabine (not including drug fever or exanthema, including known cerebellar side effects) or daunorubicin.\n      * For subjects assigned to non intensive chemotherapy, documented or suspected hypersensitivity to azacitidine or mannitol.\n     \n     \n 16. Known active drug or alcohol abuse.\n 17. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.\n 18. Pregnant females or breastfeeding female subjects.\n 19. Known recent or active suicidal ideation or behavior.\n 20. Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.","FSH",null,"Protein","Ovary","Actual","2018-01-31","Actual","Anticipated","2025-07-22","Anticipated","2019-03-01","2017-12-21","2018-01-23","2019-03-29","Yes","glasdegib;\nuntreated;\nHedgehog Inhibitor","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"All",null,"No","Yes\nPfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",null,"URL: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1371019&StudyName=A+Randomized+%281%3A1%29%2C+Double+Blind%2C+Multi+Center%2C+Placebo+Controlled+Study+Evaluating+Intensive+Chemotherapy+With+Or+Without+Glasdegib+%28pf+04449913%29+Or+Azacitidine+%28aza%29+With+Or+Without+Glasdegib+In+Patients+With+Previously+Untreated+Acute+Myeloid+Leukemia [https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1371019&StudyName=A+Randomized+%281%3A1%29%2C+Double+Blind%2C+Multi+Center%2C+Placebo+Controlled+Study+Evaluating+Intensive+Chemotherapy+With+Or+Without+Glasdegib+%28pf+04449913%29+Or+Azacitidine+%28aza%29+With+Or+Without+Glasdegib+In+Patients+With+Previously+Untreated+Acute+Myeloid+Leukemia] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To obtain contact information for a study center near you, click here.",null,"Yes","No",{"$nulls":17},"2017-002822-19|BRIGHT|BRIGHT AML1019","EudraCT Number|Alias Study Number","Overall survival","5 years after last subject randomized",null,"Fatigue score measured by the MD Anderson Symptom Inventory (MDASI)-AML/MDS questionnaire|Rate of Complete Remission (CR) (including CR with minimal residual disease (MRD)-negative as assessed by multiparametric flow cytometry)|Duration of response (defined as CR [includes CR-MRD negative]/CRi or CR/CRh as appropriate)|Time to response (CR[includes CR-MRD negative)]/CR with partial hematologic rcovery (CRh) as appropriate)|Event-free Survival|Patient Reported Outcomes (PROs) as measured by the M.D. Anderson Symptom Inventory AML/MDS Module (MDASI-AML/MDS)|Adverse events as graded by NCI CTCAE v4.03|Laboratory abnormalities as graded by NCI CTCAE v4.03|For the intensive study, the plasma trough concentration (Ctrough) will be analyzed|QTc interval|PROs as measured by Patient Global Impression of Change (PGIC)|Patient Reported Outcomes (PROs) as measured by EuroQoL 5 Dimension questionnaire 5-Level version (EQ-5D-5L)|Patient Reported Outcomes (PROs) as measured by Patient Global Impression of Symptoms (PGIS)|Complete Remission with incomplete hematologic recovery (CRi)|Rate of morphological leukemia-free state (MLFS)|Rate of Partial Remission (PR)|Rate of Complete Remission with partial hematological recovery (CRh) for the Non-intensive study only only|Minimum Observed Plasma Trough Concentratrion of glasdegib in the Intensive Study|Minimum Observed Plasma Trough Concentration of glasdegib in the Non-intensive study","Scale is from 0-10 where 0 is not present and 10 is as bad as you can image.|Response as defined by the 2017 European LeukemiaNet (ELN) recommendations.|5 years after last subject randomized, consent withdrawal, or death|Measurement Scale from 0-10.|PK samples taken on Induction(s) Day 1 (1 and 4 hours post induction); Induction(s) Day 10 (pre-dose, 1 and 4 hours post dose); Day 1 of each Consolidation cycle (pre-dose, 1 and 4 hours post dose)|One question asking for description of leukemia symptoms.|Series of questions that ask for information that best describes health.|One question asking for information regarding leukemia symptoms.|Its the minimum trough concentration in plasma of glasdegib following multiple daily dosing to steady state.|It is the minimum trough concentration in plasma of glasdegib following multiple daily dosing to steady state.","5 years after last subject randomized, consent withdrawal, or death|2 years after last dose of study therapy|5 years after last patient randomized, withdrawal, or death|5 years after last subject randomized, withdrawal, or death|Day 10 of Induction Cycle and Day 1 of each Consolidation Cycle|Cycle 1 Day 15 and Cycles 2 and 3 on Day 1","ClinicalTrials.gov_Inquiries@pfizer.com","Pfizer CT.gov Call Center","1-800-718-1021","Adelaide, South|Darlinghurst, New South Wales, Australia, 2010 St George HospitalKogarah, New South Wales, Australia, 2217|Salzburg, Austria, 5020 Uniklinikum Salzburg, Landeskrankenhaus Salzburg,Salzburg, Austria, 5020 Sozialmedizinisches Zentrum Sud.Wien, Austria, 1100 Krankenhaus Hietzing Mit Neurologischem Zentrum RosenhugelWien, Austria, I130|Leuven, Belgium, B-3000|Winnipeg, Manitoba, Canada, R3A 1R9 Cancercare ManitobaWinnipeg, Manitoba, Canada, R3E 0V9|Toronto, Ontario, Canada, M5G 2M9|Montreal, Quebec, Canada, H1T 2M4|Brno, Czechia, 100 34 Nemocnicni LekarnaBrno, Czechia, 625 00 InternÃ­ HematologickÃ¡ Klinika, Fakultni Nemocnice KrÃ¡lovskÃ© VinohradyPraha 10, Czechia, 100 34 Ãšstavni LÃ©kÃ¡rnaPraha 10, Czechia, 100 34|Creteil, France, 94010 Chu Henri MondorCrÃ©teil, France, 94010 Chu De NantesNantes Cedex 1, France, 44093 Chu De Nantes Hotel DieuNantes Cedex, France, 44093 Hopital Saint LouisParis, France, 75010 Centre Hospitalier Lyon Sud -Unite De Pharmacie Clinique OncologiquePierre Benite Cedex, France, 69495 Centre Hospitalier Lyon Sud - Service D'HematologiePierre Benite Cedex, France, 69495 Institut Gustave RoussyVillejuif Cedex, France, 94805|Debrecen, Hungary, 4032 Debreceni Egyetem Klinikai Kozpont Belgyogyaszati KlinikaDebrecen, Hungary, 4032 Petz AladÃ¡r Megyei OktatÃ³ KÃ³rhÃ¡z, GyÃ³gyszerÃ©szeti OsztÃ¡lyGyÅ‘r, Hungary, 9024 Petz AladÃ¡r Megyei OktatÃ³ KÃ³rhÃ¡z, Ii. BelgyÃ³gyÃ¡szat- HematolÃ³giai OsztÃ¡lyGyÅ‘r, Hungary, 9024|Boston, Massachusetts, United States, 02215|Jerusalem, Israel, 91120|Ancona, An, Italy, 60126 Sod Farmacia-Dipt Dei Servizi -Aou Ospedali Riuniti Umberto I, G.M. Lancisi, G. SalesiTorette Di Ancona, An, Italy, 60126|Cona, Ferrara, Fe, Italy, 44124 Farmacia OspedalieraFerrara, Fe, Italy, 44121|Pesaro, Pu, Italy, 61122|Nagoya, Aichi, Japan, 466-8650|Akita, Japan, 010-8543 Kyushu University HospitalFukuoka, Japan, 812-8582 National Hospital Organization Kumamoto Medical Center[Active, Not Recruiting]Kumamoto, Japan, 860-0008 Nagasaki University HospitalNagasaki, Japan, 852-8501 Tokyo Medical University HospitalTokyo, Japan, 160-0023 Korea, Republic Of, Jeollabuk-Do Chonbuk National University HospitalJeonju-Si, Jeollabuk-Do, Korea, Republic Of, 54907 Korea, Republic Of, Jeollanam-Do Chonnam National University Hwasun HospitalHwasun-Gun, Jeollanam-Do, Korea, Republic Of, 58128 Korea, Republic Of Department Of Pharmacy, Inje University Busan Paik HospitalBusan, Korea, Republic Of, 47392 Inje University Busan Paik HospitalBusan, Korea, Republic Of, 47392 Clinical Trial Pharmacy, Keimyung University Dongsan HospitalDaegu, Korea, Republic Of, 41931 Keimyung University Dongsan HospitalDaegu, Korea, Republic Of, 41931 Gachon University Gil Medical CenterIncheon, Korea, Republic Of, 21565 Seoul National University HospitalSeoul, Korea, Republic Of, 03080 Severance Hospital, Yonsei University Health SystemSeoul, Korea, Republic Of, 03722 Department Of Pharmacy, Samsung Medical CenterSeoul, Korea, Republic Of, 06351 Samsung Medical CenterSeoul, Korea, Republic Of, 06351 The Catholic University Of Korea Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591 The Catholic University Of Korea, Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591|Yoshida-Gun, Fukui, Japan, 910-1193|Maebashi, Gunma, Japan, 371-8511|Kobe-Shi, Hyogo, Japan, 650-0017|Yokohama, Kanagawa, Japan, 232-0024|Sendai, Miyagi, Japan, 980-8574|Osaka-City, Osaka, Japan, 545-8586 Kindai University HospitalOsaka-Sayama, Osaka, Japan, 589-8511|Sunto-Gun, Shizuoka, Japan, 411-8777|Tachikawa, Tokyo, Japan, 190-0014|MÃ©xico, MÃ©x, Mexico, 14080|Gdansk, Poland, 80-214 Wwcoit Im. M. Kopernika W LodziLodz, Poland, 93-513|Cluj-Napoca, Cluj, Romania, 400124|Craiova, Dolj, Romania, 200136|Bucuresti, Romania, 010825 Spitalul Clinic Coltea, Clinica De HematologieBucuresti, Romania, 030171 Russian Federation Sbhi Cch No. 40 Hd MoscowMoscow, Russian Federation, 129301 State Budgetary Healthcare Institution Of MoscowMoscow, Russian Federation, 129301 Sbhi Nnr Nn Rch N. A. N.A. SemashkoNizhniy Novgorod, Russian Federation, 603126 State Budgetary Institution Of Ryazan Region 'Regional Clinical Hospital' (Sbi Rr Rch)Ryazan, Russian Federation, 390039 Fsbi Russrhti Fmba Of|Barcelona, Spain, 08003 Hospital De La Santa Creu I Sant PauBarcelona, Spain, 08025 Hospital Universitario Arnau De VilanovaLleida, Spain, 25198 Hospital General Universitario Gregorio MaranonMadrid, Spain, 28007 Hospital Universitario Ramon Y CajalMadrid, Spain, 28034 Hospital Universitario Virgen Del RocioSevilla, Spain, 41013 Hospital Universitari I Politecnic La FeValencia, Spain, 46026|Orebro, Sweden, 701 85 Universitetssjukhuset OrebroOrebro, Sweden, 701 85 Karolinska Universitetssjukhuset HuddingeStockholm, Sweden, 141 86 Taiwan National Cheng Kung University HospitalTainan, Taiwan, 704 National Taiwan University HospitalTaipei, Taiwan, 100 Department Of Clinical Trial Pharmacy, Taipei Veterans General HospitalTaipei, Taiwan, 11217 Taipei Veterans General HospitalTaipei, Taiwan, 11217 Division Of Pharmacy, Koo Foundation Sun Yat-Sen Cancer CenterTaipei, Taiwan, 112 Koo Foundation Sun Yat-Sen Cancer CenterTaipei, Taiwan, 112 Chang Gung Memorial Hospital-Linkou BranchTaoyuan City, Taiwan, 333 Chemotherapy Pharmacy, Chang Gung Memorial Hospital-Linkou BranchTaoyuan City, Taiwan, 333|Sutton, Surrey, United Kingdom, Sm2 5Pt|London, United Kingdom, Ec1A 7Be Imperial College Healthcare Nhs TrustLondon, United Kingdom, W12 0Hs|Los Angeles, California, United States, 90033 Lac+Usc Medical CenterLos Angeles, California, United States, 90033 Usc/Norris Comprehensive Cancer Center / Investigational Drug ServicesLos Angeles, California, United States, 90033 Usc/Norris Comprehensive Cancer CenterLos Angeles, California, United States, 90033 Rrmc - UclaLos Angeles, California, United States, 90095 Ucla Department Of MedicineLos Angeles, California, United States, 90095 Ucla Hematology/Oncology ClinicLos Angeles, California, United States, 90095 Ucla Ronald Reagan Medical CenterLos Angeles, California, United States, 90095 Keck Medicine Of Usc Norris Oncology/Hematology - Newport Beach Treatment CenterNewport Beach, California, United States, 92663 Usc Norris Oncology/Hematology - Newport BeachNewport Beach, California, United States, 92663 Uc Irvine Health - Chao Family Comprehensive Cancer CenterOrange, California, United States, 92868-3201 Uc Irvine Medical CenterOrange, California, United States, 92868-3201 Ucsf Helen Diller Family Comprehensive Cancer CenterSan Francisco, California, United States, 94143 University Of California, San Francisco Medical CenterSan Francisco, California, United States, 94143 University Of California, San FranciscoSan Francisco, California, United States, 94143|Boston, Massachusetts, United States, 02111 Massachusetts General HospitalBoston, Massachusetts, United States, 02114 Beth|Kansas City, Missouri, United States, 64132|Lake Success, New York, United States, 11042 North Shore University HospitalManhasset, New York, United States, 11030 Long Island Jewish Medical CenterNew Hyde Park, New York, United States, 11040 University Of Rochester Cancer Center PharmacyRochester, New York, United States, 14642 University Of Rochester Medical CenterRochester, New York, United States, 14642|Cleveland, Ohio, United States, 44106 University Hospitals Cleveland Medical CenterCleveland, Ohio, United States, 44106 Cleveland Clinic FoundationCleveland, Ohio, United States, 44195|Nashville, Tennessee, United States, 37203|Dallas, Texas, United States, 75246 Baylor University Medical CenterDallas, Texas, United States, 75246 Blood Cancer And Stem Cell Transplant ClinicSan Antonio, Texas, United States, 78229 Methodist Healthcare System Of San AntonioSan Antonio, Texas, United States, 78229 Methodist Hospital Investigational PharmacySan Antonio, Texas, United States, 78229|Seattle, Washington, United States, 98104 Swedish Investigational Drug Services PharmacySeattle, Washington, United States, 98104 Swedish Medical CenterSeattle, Washington, United States, 98122","California|Massachusetts|Missouri|New York|Ohio|Tennessee|Texas|Washington","Australia|Austria|Belgium|Canada|Czechia|France|Hungary|Israel|Italy|Japan|Mexico|Poland|Romania|Spain|Sweden|United Kingdom|United States","Australia, 5000 Royal Adelaide Hospital|New South Wales St Vincent's Hospital Sydney|Royal Adelaide Hospital - Clinical Trials Pharmacy|Landeskrankenhaus Salzburg, Universitaetsklinik Fuer Innere Medizin Iii Der Pmu|Universitaire Ziekenhuizen Leuven|Manitoba Health Sciences Centre|Ontario Princess Margaret Cancer Centre|Quebec Ciusss De L'Est-De-L'Ile-De- MontrÃ©al - HÃ´pital Maisonneuve-Rosemont|Interni Hematologicka A Onkologicka Klinika, Fakultni Nemocnice Brno|Chu Henri Mondor|Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Klinika, Hematologia Tanszek|Deaconess Medical Center|Hadassah Medical Center (Ein Kerem)|An Aou Ospedali Riuniti Umberto I, G.M. Lancisi, G. Salesi, Clinica Di Ematologia|Fe A.O.U. Di Ferrara- Arcispedale Sant'Anna,|Pu Ao Ospedali Riuniti Marche Nord - Presidio Ospedaliero San Salvatore Di Pesaro -|Aichi Japanese Red Cross Nagoya Daini Hospital|Akita University Hospital|Fukui University Of Fukui Hospital|Gunma Gunma University Hospital|Hyogo Kobe University Hospital|Kanagawa Yokohama City University Medical Center|Miyagi Tohoku University Hospital|Osaka Osaka City University Hospital|Shizuoka Shizuoka Cancer Center|Tokyo National Hospital Organization Disaster Medical Center|MÃ©x Instituto Nacional De CancerologÃ­a|Klinika Hematologii I Transplantologii Uniwersyteckie Centrum Kliniczne|Cluj Institutul Oncologic 'Prof. Dr. Ion Chiricuta'|Dolj Spitalul Clinic Municipal Filantropia Craiova, Sectia Clinica Hematologie|Spitalul Universitar De Urgenta Militar Central \"Dr. Carol Davila\" Bucuresti|Hospital Del Mar|Apoex Vn|, Surrey The Royal Marsden Nhs Foundation Trust|Barts Health Nhs Trust|Keck Hospital Of Usc|Tufts Medical Center|Midamerica Division, Inc., C/O Research Medical Center|Northwell Health/Monter Cancer Center|Taussig Cancer Center Investigational Pharmacy|The Sarah Cannon Research Institute|Baylor Scott And White Research Institute|Swedish Cancer Institute",{"$nulls":3},"Pfizer CT.gov Call Center","2019-03-29","2020-05-25T16:39:34.557","2020-05-26T17:10:42.972","NCT03416179"]
["5ecbf4c711702c1b1b916bc9","NCT03416179","2019-04-03","Pfizer","PFE","Recruiting","A Study Evaluating Intensive Chemotherapy With or Without Glasdegib or Azacitidine With or Without Glasdegib In Patients With Previously Untreated Acute Myeloid Leukemia (BRIGHT AML1019)","Glasdegib|Cytarabine|Daunorubicin|Azacitidine","Hh Inhibitor|DNA Polymerase Inhibitor|Nucleic Acid Synthesis Inhibitor|TOP2 Inhibitor|DNA Mtase Inhibitor","Unknown",null,"Unknown",null,"Phase 3",4,720,"Anticipated","2018-04-20","2021-06-13","OS","Overall Survival",{"$nulls":3},"Glasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).\n\nGlasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).","Two separate registration trials conducted under one protocol number are proposed to adequately and independently evaluate the addition of glasdegib in intensive and non-intensive chemotherapy populations. Each study will have an experimental treatment arm and a placebo arm. Endpoints are the same for each study except where specifically indicated.\n\nAssignment to the Intensive Study or the Non-Intensive Study will be made by the Investigator based on the 2017 European LeukemiaNet (ELN) recommendations.\n\nStudy B1371019 is a randomized (1:1), double-blind, multi-center, placebo controlled study of chemotherapy in combination with glasdegib versus chemotherapy in combination with placebo in adult patients with previously untreated AML.\n\nGlasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).\n\nGlasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).","A RANDOMIZED (1:1), DOUBLE-BLIND, MULTI-CENTER, PLACEBO CONTROLLED STUDY EVALUATING INTENSIVE CHEMOTHERAPY WITH OR WITHOUT GLASDEGIB (PF-04449913) OR AZACITIDINE (AZA) WITH OR WITHOUT GLASDEGIB IN PATIENTS WITH PREVIOUSLY UNTREATED ACUTE MYELOID LEUKEMIA","B1371019","Leukemia, Myeloid, Acute","Acute Leukemia|Acute Myeloid Leukemia|Myeloid Leukemia|Leukemia","Oncology Hematological","Oncology","Experimental|Placebo Comparator","Arm A (Intensive Study)|Arm B (Intensive Study)|Arm A (Non-intensive study)|Arm B (Non-intensive study)","Glasdegib + '7+3' Induction(s)|Placebo + '7+3' Induction(s)|Glasdegib + azacitidine|Placebo + azacitidine","Drug|Procedure","glasdegib|daunorubicin + cytarabine|cytarabine|HSCT|Placebo|azacitidine","Daily Glasdegib (100 mg, PO), beginning on Day 1 and is to continue up to 2 years post randomization.\n\nFollowing consolidation therapy, glasdegib or placebo will be administered daily for up to 2 years after randomization or until they have minimal residual disease (MRD) negative disease, whichever comes first.\n\nDaily Glasdegib (100 mg, PO) or matching placebo will continue throughout Induction(s) and Consolidation therapies regardless of dose modifications/delays in the chemotherapy.|Consolidation with single agent cytarabine 3 g/m2 IV for adults <60 years and 1 g/m2 for adults 60 years over 3 BID on Days 1, 3, and 5, every 28 days for up to 4 cycles or alternative single agent cytarabine consolidation schedules may be used per local prescribing information.|If required, and done per standard of care post Induction(s).|Azacitidine (75 mg/m2, SC or IV) daily for 7 days, in 28 day cycles for as long as they do not meet the criteria for disease progression, unacceptable toxicity, consent withdrawal, or death.|Matching placebo (PO) is to be administered by mouth daily beginning on Day 1 of chemotherapy and will continue if subjects demonstrate reasonable evidence of clinical benefit and do not meet the criteria for progression regardless of any delays/modifications in the chemotherapy treatment. Subjects will continue placebo until disease progression, unacceptable toxicity, consent withdrawal, or death, whichever comes first.","PF-04449913","Arm A (Intensive Study)|Arm B (Intensive Study)|Arm A (Non-intensive study)|Arm B (Non-intensive study)","\n\nSubjects must meet all of the following inclusion criteria to be eligible for enrollment into the Intensive and Non Intensive study (unless where indicated):\n\n 1.  Subjects with untreated AML according to the World Health Organization (WHO) 2016 Classification2, including those with: * AML arising from MDS or another antecedent hematologic disease (AHD).\n      * AML after previous cytotoxic therapy or radiation (secondary AML).\n     \n     \n 2.  18 years of age (In Japan, 20 years of age).\n 3.  Adequate Organ Function as defined by the following: * Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) 3 x upper limit of normal (ULN), excluding subjects with liver function abnormalities due to underlying malignancy.\n      * Total serum bilirubin 2 x ULN (except subjects with documented Gilbert's syndrome).\n      * Estimated creatinine clearance 30 mL/min as calculated using the standard method for the institution.\n     \n     \n 4.  QTc interval 470 msec using the Fridericia correction (QTcF).\n 5.  All anti cancer treatments (unless specified) should be discontinued 2 weeks from study entry, for example: targeted chemotherapy, radiotherapy, investigational agents, hormones, anagrelide or cytokines. * For control of rapidly progressing leukemia, all trans retinoic acid (ATRA), hydroxyurea, and/or leukopheresis may be used before and for up to 1 week after the first dose of glasdegib.\n     \n     \n 6.  Serum or urine pregnancy test (for female subjects of childbearing potential) with a minimum sensitivity of 25 IU/L or equivalent units of human chorionic gonadotropin (hCG) negative at screening.\n 7.  Male and female subjects of childbearing potential and at risk for pregnancy must agree to use at least one highly effective method of contraception throughout the study and for 180 days after the last dose of azacitidine, cytarabine, or daunorubicin; and the last dose of glasdegib or placebo, whichever occurs later.\n 8.  Female subjects of non childbearing potential must meet at least 1 of the following criteria: 1. Have undergone a documented hysterectomy and/or bilateral oophorectomy;\n      2. Have medically confirmed ovarian failure; or\n      3. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; status may be confirmed by having a serum follicle stimulating hormone (FSH) level confirming the postmenopausal state.\n     \n     All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential.\n     \n     \n 9.  Consent to a saliva sample collection for a germline comparator, unless prohibited by local regulations or ethics committee (EC) decision.\n 10. Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.\n 11. Subjects who are willing and able to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures (including bone marrow [BM] assessments).\n\n","\n\nSubjects with any of the following characteristics/conditions will not be included in the study:\n\n 1.  Acute Promyelocytic Leukemia (APL) and APLwith PML RARA, subjects (WHO 2016 classification).\n 2.  AML with BCR ABL1 or t(9;22)(q34;q11.2) as a sole abnormality. * Complex genetics may include t(9;22) cytogenetic translocation.\n     \n     \n 3.  Subjects with known active CNS leukemia.\n 4.  Participation in other clinical studies involving other investigational drug(s) (Phases 1 4) within 4 weeks prior study entry and/or during study participation.\n 5.  Subjects known to be refractory to platelet or packed red cell transfusions per Institutional Guidelines, or a patient who refuses blood product support.\n 6.  Subjects with another active malignancy on treatment with the exception of basal cell carcinoma, non melanoma skin cancer, cervical carcinoma in situ. Other prior or concurrent malignancies will be considered on a case by case basis.\n 7.  Any one of the following ongoing or in the previous 6 months: myocardial infarction, congenital long QT syndrome, Torsades de pointes, symptomatic arrhythmias (including sustained ventricular tachyarrhythmia), right or left bundle branch block and bifascicular block, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (CHF New York Heart Association class III or IV), cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism; as well as bradycardia defined as <50 bpms.\n 8.  Subjects with an active, life threatening or clinically significant uncontrolled systemic infection not related to AML.\n 9.  Subjects with left ventricular ejection fraction (LVEF) <50% are excluded from the Intensive Chemotherapy Study only.\n 10. Cumulative anthracycline dose equivalent of 550 mg/m2 of daunorubicin for the Intensive Chemotherapy Study only.\n 11. Known malabsorption syndrome or other condition that may significantly impair absorption of study medication in the investigator's judgment (eg, gastrectomy, lap band, Crohn's disease) and inability or unwillingness to swallow tablets or capsules.\n 12. Current use or anticipated requirement for drugs that are known strong CYP3A4/5 inducers.\n 13. Concurrent administration of herbal preparations.\n 14. Major surgery or radiation within 4 weeks of starting study treatment.\n 15. Documented or suspected hypersensitivity to any one of the following: * For subjects assigned to intensive chemotherapy, documented or suspected hypersensitivity to cytarabine (not including drug fever or exanthema, including known cerebellar side effects) or daunorubicin.\n      * For subjects assigned to non intensive chemotherapy, documented or suspected hypersensitivity to azacitidine or mannitol.\n     \n     \n 16. Known active drug or alcohol abuse.\n 17. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.\n 18. Pregnant females or breastfeeding female subjects.\n 19. Known recent or active suicidal ideation or behavior.\n 20. Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.","FSH",null,"Protein","Ovary","Actual","2018-01-31","Actual","Anticipated","2025-07-22","Anticipated","2019-04-01","2017-12-21","2018-01-23","2019-04-01","Yes","glasdegib;\nuntreated;\nHedgehog Inhibitor","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"All",null,"No","Yes\nPfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",null,"URL: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1371019&StudyName=A+Randomized+%281%3A1%29%2C+Double+Blind%2C+Multi+Center%2C+Placebo+Controlled+Study+Evaluating+Intensive+Chemotherapy+With+Or+Without+Glasdegib+%28pf+04449913%29+Or+Azacitidine+%28aza%29+With+Or+Without+Glasdegib+In+Patients+With+Previously+Untreated+Acute+Myeloid+Leukemia [https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1371019&StudyName=A+Randomized+%281%3A1%29%2C+Double+Blind%2C+Multi+Center%2C+Placebo+Controlled+Study+Evaluating+Intensive+Chemotherapy+With+Or+Without+Glasdegib+%28pf+04449913%29+Or+Azacitidine+%28aza%29+With+Or+Without+Glasdegib+In+Patients+With+Previously+Untreated+Acute+Myeloid+Leukemia] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To obtain contact information for a study center near you, click here.",null,"Yes","No",{"$nulls":17},"2017-002822-19|BRIGHT|BRIGHT AML1019","EudraCT Number|Alias Study Number","Overall survival","5 years after last subject randomized",null,"Fatigue score measured by the MD Anderson Symptom Inventory (MDASI)-AML/MDS questionnaire|Rate of Complete Remission (CR) (including CR with minimal residual disease (MRD)-negative as assessed by multiparametric flow cytometry)|Duration of response (defined as CR [includes CR-MRD negative]/CRi or CR/CRh as appropriate)|Time to response (CR[includes CR-MRD negative)]/CR with partial hematologic rcovery (CRh) as appropriate)|Event-free Survival|Patient Reported Outcomes (PROs) as measured by the M.D. Anderson Symptom Inventory AML/MDS Module (MDASI-AML/MDS)|Adverse events as graded by NCI CTCAE v4.03|Laboratory abnormalities as graded by NCI CTCAE v4.03|For the intensive study, the plasma trough concentration (Ctrough) will be analyzed|QTc interval|PROs as measured by Patient Global Impression of Change (PGIC)|Patient Reported Outcomes (PROs) as measured by EuroQoL 5 Dimension questionnaire 5-Level version (EQ-5D-5L)|Patient Reported Outcomes (PROs) as measured by Patient Global Impression of Symptoms (PGIS)|Complete Remission with incomplete hematologic recovery (CRi)|Rate of morphological leukemia-free state (MLFS)|Rate of Partial Remission (PR)|Rate of Complete Remission with partial hematological recovery (CRh) for the Non-intensive study only only|Minimum Observed Plasma Trough Concentratrion of glasdegib in the Intensive Study|Minimum Observed Plasma Trough Concentration of glasdegib in the Non-intensive study","Scale is from 0-10 where 0 is not present and 10 is as bad as you can image.|Response as defined by the 2017 European LeukemiaNet (ELN) recommendations.|5 years after last subject randomized, consent withdrawal, or death|Measurement Scale from 0-10.|PK samples taken on Induction(s) Day 1 (1 and 4 hours post induction); Induction(s) Day 10 (pre-dose, 1 and 4 hours post dose); Day 1 of each Consolidation cycle (pre-dose, 1 and 4 hours post dose)|One question asking for description of leukemia symptoms.|Series of questions that ask for information that best describes health.|One question asking for information regarding leukemia symptoms.|Its the minimum trough concentration in plasma of glasdegib following multiple daily dosing to steady state.|It is the minimum trough concentration in plasma of glasdegib following multiple daily dosing to steady state.","5 years after last subject randomized, consent withdrawal, or death|2 years after last dose of study therapy|5 years after last patient randomized, withdrawal, or death|5 years after last subject randomized, withdrawal, or death|Day 10 of Induction Cycle and Day 1 of each Consolidation Cycle|Cycle 1 Day 15 and Cycles 2 and 3 on Day 1","ClinicalTrials.gov_Inquiries@pfizer.com","Pfizer CT.gov Call Center","1-800-718-1021","Adelaide, South|Darlinghurst, New South Wales, Australia, 2010 St George HospitalKogarah, New South Wales, Australia, 2217|Salzburg, Austria, 5020 Uniklinikum Salzburg, Landeskrankenhaus SalzburgSalzburg, Austria, 5020 Sozialmedizinisches Zentrum Sud.Wien, Austria, 1100 Krankenhaus Hietzing Mit Neurologischem Zentrum RosenhugelWien, Austria, I130|Leuven, Belgium, B-3000|Winnipeg, Manitoba, Canada, R3A 1R9 Cancercare ManitobaWinnipeg, Manitoba, Canada, R3E 0V9|Toronto, Ontario, Canada, M5G 2M9|Montreal, Quebec, Canada, H1T 2M4|Brno, Czechia, 100 34 Nemocnicni LekarnaBrno, Czechia, 625 00 InternÃ­ HematologickÃ¡ Klinika, Fakultni Nemocnice KrÃ¡lovskÃ© VinohradyPraha 10, Czechia, 100 34 Ãšstavni LÃ©kÃ¡rnaPraha 10, Czechia, 100 34|Creteil, France, 94010 Chu Henri MondorCrÃ©teil, France, 94010 Chu De NantesNantes Cedex 1, France, 44093 Chu De Nantes Hotel DieuNantes Cedex, France, 44093 Hopital Saint LouisParis, France, 75010 Centre Hospitalier Lyon Sud -Unite De Pharmacie Clinique OncologiquePierre Benite Cedex, France, 69495 Centre Hospitalier Lyon Sud - Service D'HematologiePierre Benite Cedex, France, 69495 Institut Gustave RoussyVillejuif Cedex, France, 94805|Debrecen, Hungary, 4032 Debreceni Egyetem Klinikai Kozpont Belgyogyaszati KlinikaDebrecen, Hungary, 4032 Petz AladÃ¡r Megyei OktatÃ³ KÃ³rhÃ¡z, GyÃ³gyszerÃ©szeti OsztÃ¡lyGyÅ‘r, Hungary, 9024 Petz AladÃ¡r Megyei OktatÃ³ KÃ³rhÃ¡z, Ii. BelgyÃ³gyÃ¡szat- HematolÃ³giai OsztÃ¡lyGyÅ‘r, Hungary, 9024|Boston, Massachusetts, United States, 02215|Jerusalem, Israel, 91120|Ancona, An, Italy, 60126 Sod Farmacia-Dipt Dei Servizi -Aou Ospedali Riuniti Umberto I, G.M. Lancisi, G. SalesiTorette Di Ancona, An, Italy, 60126|Cona, Ferrara, Fe, Italy, 44124 Farmacia OspedalieraFerrara, Fe, Italy, 44121|Pesaro, Pu, Italy, 61122|Nagoya, Aichi, Japan, 466-8650|Akita, Japan, 010-8543 Kyushu University HospitalFukuoka, Japan, 812-8582 National Hospital Organization Kumamoto Medical Center[Active, Not Recruiting]Kumamoto, Japan, 860-0008 Nagasaki University HospitalNagasaki, Japan, 852-8501 Tokyo Medical University HospitalTokyo, Japan, 160-0023 Korea, Republic Of, Jeollabuk-Do Chonbuk National University HospitalJeonju-Si, Jeollabuk-Do, Korea, Republic Of, 54907 Korea, Republic Of, Jeollanam-Do Chonnam National University Hwasun HospitalHwasun-Gun, Jeollanam-Do, Korea, Republic Of, 58128 Korea, Republic Of Department Of Pharmacy, Inje University Busan Paik HospitalBusan, Korea, Republic Of, 47392 Inje University Busan Paik HospitalBusan, Korea, Republic Of, 47392 Clinical Trial Pharmacy, Keimyung University Dongsan HospitalDaegu, Korea, Republic Of, 41931 Keimyung University Dongsan HospitalDaegu, Korea, Republic Of, 41931 Gachon University Gil Medical CenterIncheon, Korea, Republic Of, 21565 Seoul National University HospitalSeoul, Korea, Republic Of, 03080 Severance Hospital, Yonsei University Health SystemSeoul, Korea, Republic Of, 03722 Department Of Pharmacy, Samsung Medical CenterSeoul, Korea, Republic Of, 06351 Samsung Medical CenterSeoul, Korea, Republic Of, 06351 The Catholic University Of Korea Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591 The Catholic University Of Korea, Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591|Yoshida-Gun, Fukui, Japan, 910-1193|Maebashi, Gunma, Japan, 371-8511|Kobe-Shi, Hyogo, Japan, 650-0017|Yokohama, Kanagawa, Japan, 232-0024|Sendai, Miyagi, Japan, 980-8574|Osaka-City, Osaka, Japan, 545-8586 Kindai University HospitalOsaka-Sayama, Osaka, Japan, 589-8511|Sunto-Gun, Shizuoka, Japan, 411-8777|Tachikawa, Tokyo, Japan, 190-0014|MÃ©xico, MÃ©x, Mexico, 14080|Gdansk, Poland, 80-214 Wwcoit Im. M. Kopernika W LodziLodz, Poland, 93-513|Cluj-Napoca, Cluj, Romania, 400124|Craiova, Dolj, Romania, 200136|Bucuresti, Romania, 010825 Spitalul Clinic Coltea, Clinica De HematologieBucuresti, Romania, 030171 Russian Federation Sbhi Cch No. 40 Hd MoscowMoscow, Russian Federation, 129301 State Budgetary Healthcare Institution Of MoscowMoscow, Russian Federation, 129301 Sbhi Nnr Nn Rch N. A. N.A. SemashkoNizhniy Novgorod, Russian Federation, 603126 State Budgetary Institution Of Ryazan Region 'Regional Clinical Hospital' (Sbi Rr Rch)Ryazan, Russian Federation, 390039 Fsbi Russrhti Fmba Of|Barcelona, Spain, 08003 Hospital De La Santa Creu I Sant PauBarcelona, Spain, 08025 Hospital Universitario Arnau De VilanovaLleida, Spain, 25198 Hospital General Universitario Gregorio MaranonMadrid, Spain, 28007 Hospital Universitario Ramon Y CajalMadrid, Spain, 28034 Hospital Universitario Virgen Del RocioSevilla, Spain, 41013 Hospital Universitari I Politecnic La FeValencia, Spain, 46026|Orebro, Sweden, 701 85 Universitetssjukhuset OrebroOrebro, Sweden, 701 85 Karolinska Universitetssjukhuset HuddingeStockholm, Sweden, 141 86 Taiwan National Cheng Kung University HospitalTainan, Taiwan, 704 National Taiwan University HospitalTaipei, Taiwan, 100 Department Of Clinical Trial Pharmacy, Taipei Veterans General HospitalTaipei, Taiwan, 11217 Taipei Veterans General HospitalTaipei, Taiwan, 11217 Division Of Pharmacy, Koo Foundation Sun Yat-Sen Cancer CenterTaipei, Taiwan, 112 Koo Foundation Sun Yat-Sen Cancer CenterTaipei, Taiwan, 112 Chang Gung Memorial Hospital-Linkou BranchTaoyuan City, Taiwan, 333 Chemotherapy Pharmacy, Chang Gung Memorial Hospital-Linkou BranchTaoyuan City, Taiwan, 333|Sutton, Surrey, United Kingdom, Sm2 5Pt|London, United Kingdom, Ec1A 7Be Imperial College Healthcare Nhs TrustLondon, United Kingdom, W12 0Hs|Los Angeles, California, United States, 90033 Lac+Usc Medical CenterLos Angeles, California, United States, 90033 Usc/Norris Comprehensive Cancer Center / Investigational Drug ServicesLos Angeles, California, United States, 90033 Usc/Norris Comprehensive Cancer CenterLos Angeles, California, United States, 90033 Rrmc - UclaLos Angeles, California, United States, 90095 Ucla Department Of MedicineLos Angeles, California, United States, 90095 Ucla Hematology/Oncology ClinicLos Angeles, California, United States, 90095 Ucla Ronald Reagan Medical CenterLos Angeles, California, United States, 90095 Keck Medicine Of Usc Norris Oncology/Hematology - Newport Beach Treatment CenterNewport Beach, California, United States, 92663 Usc Norris Oncology/Hematology - Newport BeachNewport Beach, California, United States, 92663 Uc Irvine Health - Chao Family Comprehensive Cancer CenterOrange, California, United States, 92868-3201 Uc Irvine Medical CenterOrange, California, United States, 92868-3201 Ucsf Helen Diller Family Comprehensive Cancer CenterSan Francisco, California, United States, 94143 University Of California, San Francisco Medical CenterSan Francisco, California, United States, 94143 University Of California, San FranciscoSan Francisco, California, United States, 94143|Boston, Massachusetts, United States, 02111 Massachusetts General HospitalBoston, Massachusetts, United States, 02114 Beth|Kansas City, Missouri, United States, 64132|Lake Success, New York, United States, 11042 North Shore University HospitalManhasset, New York, United States, 11030 Long Island Jewish Medical CenterNew Hyde Park, New York, United States, 11040 University Of Rochester Cancer Center PharmacyRochester, New York, United States, 14642 University Of Rochester Medical CenterRochester, New York, United States, 14642|Cleveland, Ohio, United States, 44106 University Hospitals Cleveland Medical CenterCleveland, Ohio, United States, 44106 Cleveland Clinic FoundationCleveland, Ohio, United States, 44195|Nashville, Tennessee, United States, 37203|Dallas, Texas, United States, 75246 Baylor University Medical CenterDallas, Texas, United States, 75246 Blood Cancer And Stem Cell Transplant ClinicSan Antonio, Texas, United States, 78229 Methodist Healthcare System Of San AntonioSan Antonio, Texas, United States, 78229 Methodist Hospital Investigational PharmacySan Antonio, Texas, United States, 78229|Seattle, Washington, United States, 98104 Swedish Investigational Drug Services PharmacySeattle, Washington, United States, 98104 Swedish Medical CenterSeattle, Washington, United States, 98122","California|Massachusetts|Missouri|New York|Ohio|Tennessee|Texas|Washington","Australia|Austria|Belgium|Canada|Czechia|France|Hungary|Israel|Italy|Japan|Mexico|Poland|Romania|Spain|Sweden|United Kingdom|United States","Australia, 5000 Royal Adelaide Hospital|New South Wales St Vincent's Hospital Sydney|Royal Adelaide Hospital - Clinical Trials Pharmacy|Landeskrankenhaus Salzburg, Universitatsklinik Fur Innere Medizin Iii Der Pmu|Universitaire Ziekenhuizen Leuven|Manitoba Health Sciences Centre|Ontario Princess Margaret Cancer Centre|Quebec Ciusss De L'Est-De-L'Ile-De- MontrÃ©al - HÃ´pital Maisonneuve-Rosemont|Interni Hematologicka A Onkologicka Klinika, Fakultni Nemocnice Brno|Chu Henri Mondor|Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Klinika, Hematologia Tanszek|Deaconess Medical Center|Hadassah Medical Center (Ein Kerem)|An Aou Ospedali Riuniti Umberto I, G.M. Lancisi, G. Salesi, Clinica Di Ematologia|Fe A.O.U. Di Ferrara- Arcispedale Sant'Anna,|Pu Ao Ospedali Riuniti Marche Nord - Presidio Ospedaliero San Salvatore Di Pesaro -|Aichi Japanese Red Cross Nagoya Daini Hospital|Akita University Hospital|Fukui University Of Fukui Hospital|Gunma Gunma University Hospital|Hyogo Kobe University Hospital|Kanagawa Yokohama City University Medical Center|Miyagi Tohoku University Hospital|Osaka Osaka City University Hospital|Shizuoka Shizuoka Cancer Center|Tokyo National Hospital Organization Disaster Medical Center|MÃ©x Instituto Nacional De CancerologÃ­a|Klinika Hematologii I Transplantologii Uniwersyteckie Centrum Kliniczne|Cluj Institutul Oncologic 'Prof. Dr. Ion Chiricuta'|Dolj Spitalul Clinic Municipal Filantropia Craiova, Sectia Clinica Hematologie|Spitalul Universitar De Urgenta Militar Central \"Dr. Carol Davila\" Bucuresti|Hospital Del Mar|Apoex Vn|, Surrey The Royal Marsden Nhs Foundation Trust|Barts Health Nhs Trust|Keck Hospital Of Usc|Tufts Medical Center|Midamerica Division, Inc., C/O Research Medical Center|Northwell Health/Monter Cancer Center|Taussig Cancer Center Investigational Pharmacy|The Sarah Cannon Research Institute|Baylor Scott And White Research Institute|Swedish Cancer Institute",{"$nulls":3},"Pfizer CT.gov Call Center","2019-04-01","2020-05-25T16:39:35.060","2020-05-26T17:10:42.972","NCT03416179"]
["5ecbf4c6e2561b1b11905eb6","NCT03416179","2019-05-24","Pfizer","PFE","Recruiting","A Study Evaluating Intensive Chemotherapy With or Without Glasdegib or Azacitidine With or Without Glasdegib In Patients With Previously Untreated Acute Myeloid Leukemia (BRIGHT AML1019)","Glasdegib|Cytarabine|Daunorubicin|Azacitidine","Hh Inhibitor|DNA Polymerase Inhibitor|Nucleic Acid Synthesis Inhibitor|TOP2 Inhibitor|DNA Mtase Inhibitor","Unknown",null,"Unknown",null,"Phase 3",4,720,"Anticipated","2018-04-20","2021-06-13","OS","Overall Survival",{"$nulls":3},"Glasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).\n\nGlasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).","Two separate registration trials conducted under one protocol number are proposed to adequately and independently evaluate the addition of glasdegib in intensive and non-intensive chemotherapy populations. Each study will have an experimental treatment arm and a placebo arm. Endpoints are the same for each study except where specifically indicated.\n\nAssignment to the Intensive Study or the Non-Intensive Study will be made by the Investigator based on the 2017 European LeukemiaNet (ELN) recommendations.\n\nStudy B1371019 is a randomized (1:1), double-blind, multi-center, placebo controlled study of chemotherapy in combination with glasdegib versus chemotherapy in combination with placebo in adult patients with previously untreated AML.\n\nGlasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).\n\nGlasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).","A RANDOMIZED (1:1), DOUBLE-BLIND, MULTI-CENTER, PLACEBO CONTROLLED STUDY EVALUATING INTENSIVE CHEMOTHERAPY WITH OR WITHOUT GLASDEGIB (PF-04449913) OR AZACITIDINE (AZA) WITH OR WITHOUT GLASDEGIB IN PATIENTS WITH PREVIOUSLY UNTREATED ACUTE MYELOID LEUKEMIA","B1371019","Leukemia, Myeloid, Acute","Acute Leukemia|Acute Myeloid Leukemia|Myeloid Leukemia|Leukemia","Oncology Hematological","Oncology","Experimental|Placebo Comparator","Arm A (Intensive Study)|Arm B (Intensive Study)|Arm A (Non-intensive study)|Arm B (Non-intensive study)","Glasdegib + '7+3' Induction(s)|Placebo + '7+3' Induction(s)|Glasdegib + azacitidine|Placebo + azacitidine","Drug|Procedure","glasdegib|daunorubicin + cytarabine|cytarabine|HSCT|Placebo|azacitidine","Daily Glasdegib (100 mg, PO), beginning on Day 1 and is to continue up to 2 years post randomization.\n\nFollowing consolidation therapy, glasdegib or placebo will be administered daily for up to 2 years after randomization or until they have minimal residual disease (MRD) negative disease, whichever comes first.\n\nDaily Glasdegib (100 mg, PO) or matching placebo will continue throughout Induction(s) and Consolidation therapies regardless of dose modifications/delays in the chemotherapy.|Consolidation with single agent cytarabine 3 g/m2 IV for adults <60 years and 1 g/m2 for adults 60 years over 3 BID on Days 1, 3, and 5, every 28 days for up to 4 cycles or alternative single agent cytarabine consolidation schedules may be used per local prescribing information.|If required, and done per standard of care post Induction(s).|Azacitidine (75 mg/m2, SC or IV) daily for 7 days, in 28 day cycles for as long as they do not meet the criteria for disease progression, unacceptable toxicity, consent withdrawal, or death.|Matching placebo (PO) is to be administered by mouth daily beginning on Day 1 of chemotherapy and will continue if subjects demonstrate reasonable evidence of clinical benefit and do not meet the criteria for progression regardless of any delays/modifications in the chemotherapy treatment. Subjects will continue placebo until disease progression, unacceptable toxicity, consent withdrawal, or death, whichever comes first.","PF-04449913","Arm A (Intensive Study)|Arm B (Intensive Study)|Arm A (Non-intensive study)|Arm B (Non-intensive study)","\n\nSubjects must meet all of the following inclusion criteria to be eligible for enrollment into the Intensive and Non Intensive study (unless where indicated):\n\n 1.  Subjects with untreated AML according to the World Health Organization (WHO) 2016 Classification2, including those with: * AML arising from MDS or another antecedent hematologic disease (AHD).\n      * AML after previous cytotoxic therapy or radiation (secondary AML).\n     \n     \n 2.  18 years of age (In Japan, 20 years of age).\n 3.  Adequate Organ Function as defined by the following: * Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) 3 x upper limit of normal (ULN), excluding subjects with liver function abnormalities due to underlying malignancy.\n      * Total serum bilirubin 2 x ULN (except subjects with documented Gilbert's syndrome).\n      * Estimated creatinine clearance 30 mL/min as calculated using the standard method for the institution.\n     \n     \n 4.  QTc interval 470 msec using the Fridericia correction (QTcF).\n 5.  All anti cancer treatments (unless specified) should be discontinued 2 weeks from study entry, for example: targeted chemotherapy, radiotherapy, investigational agents, hormones, anagrelide or cytokines. * For control of rapidly progressing leukemia, all trans retinoic acid (ATRA), hydroxyurea, and/or leukopheresis may be used before and for up to 1 week after the first dose of glasdegib.\n     \n     \n 6.  Serum or urine pregnancy test (for female subjects of childbearing potential) with a minimum sensitivity of 25 IU/L or equivalent units of human chorionic gonadotropin (hCG) negative at screening.\n 7.  Male and female subjects of childbearing potential and at risk for pregnancy must agree to use at least one highly effective method of contraception throughout the study and for 180 days after the last dose of azacitidine, cytarabine, or daunorubicin; and the last dose of glasdegib or placebo, whichever occurs later.\n 8.  Female subjects of non childbearing potential must meet at least 1 of the following criteria: 1. Have undergone a documented hysterectomy and/or bilateral oophorectomy;\n      2. Have medically confirmed ovarian failure; or\n      3. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; status may be confirmed by having a serum follicle stimulating hormone (FSH) level confirming the postmenopausal state.\n     \n     All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential.\n     \n     \n 9.  Consent to a saliva sample collection for a germline comparator, unless prohibited by local regulations or ethics committee (EC) decision.\n 10. Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.\n 11. Subjects who are willing and able to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures (including bone marrow [BM] assessments).\n\n","\n\nSubjects with any of the following characteristics/conditions will not be included in the study:\n\n 1.  Acute Promyelocytic Leukemia (APL) and APLwith PML RARA, subjects (WHO 2016 classification).\n 2.  AML with BCR ABL1 or t(9;22)(q34;q11.2) as a sole abnormality. * Complex genetics may include t(9;22) cytogenetic translocation.\n     \n     \n 3.  Subjects with known active CNS leukemia.\n 4.  Participation in other clinical studies involving other investigational drug(s) (Phases 1 4) within 4 weeks prior study entry and/or during study participation.\n 5.  Subjects known to be refractory to platelet or packed red cell transfusions per Institutional Guidelines, or a patient who refuses blood product support.\n 6.  Subjects with another active malignancy on treatment with the exception of basal cell carcinoma, non melanoma skin cancer, cervical carcinoma in situ. Other prior or concurrent malignancies will be considered on a case by case basis.\n 7.  Any one of the following ongoing or in the previous 6 months: myocardial infarction, congenital long QT syndrome, Torsades de pointes, symptomatic arrhythmias (including sustained ventricular tachyarrhythmia), right or left bundle branch block and bifascicular block, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (CHF New York Heart Association class III or IV), cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism; as well as bradycardia defined as <50 bpms.\n 8.  Subjects with an active, life threatening or clinically significant uncontrolled systemic infection not related to AML.\n 9.  Subjects with left ventricular ejection fraction (LVEF) <50% are excluded from the Intensive Chemotherapy Study only.\n 10. Cumulative anthracycline dose equivalent of 550 mg/m2 of daunorubicin for the Intensive Chemotherapy Study only.\n 11. Known malabsorption syndrome or other condition that may significantly impair absorption of study medication in the investigator's judgment (eg, gastrectomy, lap band, Crohn's disease) and inability or unwillingness to swallow tablets or capsules.\n 12. Current use or anticipated requirement for drugs that are known strong CYP3A4/5 inducers.\n 13. Concurrent administration of herbal preparations.\n 14. Major surgery or radiation within 4 weeks of starting study treatment.\n 15. Documented or suspected hypersensitivity to any one of the following: * For subjects assigned to intensive chemotherapy, documented or suspected hypersensitivity to cytarabine (not including drug fever or exanthema, including known cerebellar side effects) or daunorubicin.\n      * For subjects assigned to non intensive chemotherapy, documented or suspected hypersensitivity to azacitidine or mannitol.\n     \n     \n 16. Known active drug or alcohol abuse.\n 17. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.\n 18. Pregnant females or breastfeeding female subjects.\n 19. Known recent or active suicidal ideation or behavior.\n 20. Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.","FSH",null,"Protein","Ovary","Actual","2018-01-31","Actual","Anticipated","2025-07-22","Anticipated","2019-05-01","2017-12-21","2018-01-23","2019-05-23","Yes","glasdegib;\nuntreated;\nHedgehog Inhibitor","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"All",null,"No","Yes\nPfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",null,"URL: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1371019&StudyName=A+Randomized+%281%3A1%29%2C+Double+Blind%2C+Multi+Center%2C+Placebo+Controlled+Study+Evaluating+Intensive+Chemotherapy+With+Or+Without+Glasdegib+%28pf+04449913%29+Or+Azacitidine+%28aza%29+With+Or+Without+Glasdegib+In+Patients+With+Previously+Untreated+Acute+Myeloid+Leukemia [https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1371019&StudyName=A+Randomized+%281%3A1%29%2C+Double+Blind%2C+Multi+Center%2C+Placebo+Controlled+Study+Evaluating+Intensive+Chemotherapy+With+Or+Without+Glasdegib+%28pf+04449913%29+Or+Azacitidine+%28aza%29+With+Or+Without+Glasdegib+In+Patients+With+Previously+Untreated+Acute+Myeloid+Leukemia] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To obtain contact information for a study center near you, click here.",null,"Yes","No",{"$nulls":17},"2017-002822-19|BRIGHT|BRIGHT AML1019","EudraCT Number|Alias Study Number","Overall survival","5 years after last subject randomized",null,"Fatigue score measured by the MD Anderson Symptom Inventory (MDASI)-AML/MDS questionnaire|Rate of Complete Remission (CR) (including CR with minimal residual disease (MRD)-negative as assessed by multiparametric flow cytometry)|Duration of response (defined as CR [includes CR-MRD negative]/CRi or CR/CRh as appropriate)|Time to response (CR[includes CR-MRD negative)]/CR with partial hematologic rcovery (CRh) as appropriate)|Event-free Survival|Patient Reported Outcomes (PROs) as measured by the M.D. Anderson Symptom Inventory AML/MDS Module (MDASI-AML/MDS)|Adverse events as graded by NCI CTCAE v4.03|Laboratory abnormalities as graded by NCI CTCAE v4.03|For the intensive study, the plasma trough concentration (Ctrough) will be analyzed|QTc interval|PROs as measured by Patient Global Impression of Change (PGIC)|Patient Reported Outcomes (PROs) as measured by EuroQoL 5 Dimension questionnaire 5-Level version (EQ-5D-5L)|Patient Reported Outcomes (PROs) as measured by Patient Global Impression of Symptoms (PGIS)|Complete Remission with incomplete hematologic recovery (CRi)|Rate of morphological leukemia-free state (MLFS)|Rate of Partial Remission (PR)|Rate of Complete Remission with partial hematological recovery (CRh) for the Non-intensive study only only|Minimum Observed Plasma Trough Concentratrion of glasdegib in the Intensive Study|Minimum Observed Plasma Trough Concentration of glasdegib in the Non-intensive study","Scale is from 0-10 where 0 is not present and 10 is as bad as you can image.|Response as defined by the 2017 European LeukemiaNet (ELN) recommendations.|5 years after last subject randomized, consent withdrawal, or death|Measurement Scale from 0-10.|PK samples taken on Induction(s) Day 1 (1 and 4 hours post induction); Induction(s) Day 10 (pre-dose, 1 and 4 hours post dose); Day 1 of each Consolidation cycle (pre-dose, 1 and 4 hours post dose)|One question asking for description of leukemia symptoms.|Series of questions that ask for information that best describes health.|One question asking for information regarding leukemia symptoms.|Its the minimum trough concentration in plasma of glasdegib following multiple daily dosing to steady state.|It is the minimum trough concentration in plasma of glasdegib following multiple daily dosing to steady state.","5 years after last subject randomized, consent withdrawal, or death|2 years after last dose of study therapy|5 years after last patient randomized, withdrawal, or death|5 years after last subject randomized, withdrawal, or death|Day 10 of Induction Cycle and Day 1 of each Consolidation Cycle|Cycle 1 Day 15 and Cycles 2 and 3 on Day 1","ClinicalTrials.gov_Inquiries@pfizer.com","Pfizer CT.gov Call Center","1-800-718-1021","Adelaide, South|Darlinghurst, New South Wales, Australia, 2010 St George HospitalKogarah, New South Wales, Australia, 2217|Salzburg, Austria, 5020 Uniklinikum Salzburg, Landeskrankenhaus SalzburgSalzburg, Austria, 5020 Sozialmedizinisches Zentrum Sud.Wien, Austria, 1100 Krankenhaus Hietzing Mit Neurologischem Zentrum RosenhugelWien, Austria, I130|Brugge, Belgium, B-8000 Az Sint-Jan Brugge-Oostende AvBrugge, Belgium, B-8000 Universitaire Ziekenhuizen LeuvenLeuven, Belgium, B-3000|Winnipeg, Manitoba, Canada, R3A 1R9 Cancercare ManitobaWinnipeg, Manitoba, Canada, R3E 0V9|Toronto, Ontario, Canada, M5G 2M9|Montreal, Quebec, Canada, H1T 2M4|Qingdao, Shandong, China, 266071|Tianjin, Tianjin, China, 300020|Hangzhou, Zhejiang, China, 310003|Brno, Czechia, 100 34 Nemocnicni LekarnaBrno, Czechia, 625 00 InternÃ­ HematologickÃ¡ Klinika, Fakultni Nemocnice KrÃ¡lovskÃ© VinohradyPraha 10, Czechia, 100 34 Ãšstavni LÃ©kÃ¡rnaPraha 10, Czechia, 100 34|Creteil, France, 94010 Chu Henri MondorCrÃ©teil, France, 94010 Chu De NantesNantes Cedex 1, France, 44093 Chu De Nantes Hotel DieuNantes Cedex, France, 44093 Hopital Saint LouisParis, France, 75010 Centre Hospitalier Lyon Sud -Unite De Pharmacie Clinique OncologiquePierre Benite Cedex, France, 69495 Centre Hospitalier Lyon Sud - Service D'HematologiePierre Benite Cedex, France, 69495 Institut Gustave RoussyVillejuif Cedex, France, 94805|Debrecen, Hungary, 4032 Debreceni Egyetem Klinikai Kozpont Belgyogyaszati KlinikaDebrecen, Hungary, 4032 Petz AladÃ¡r Megyei OktatÃ³ KÃ³rhÃ¡z, GyÃ³gyszerÃ©szeti OsztÃ¡lyGyÅ‘r, Hungary, 9024 Petz AladÃ¡r Megyei OktatÃ³ KÃ³rhÃ¡z, Ii. BelgyÃ³gyÃ¡szat- HematolÃ³giai OsztÃ¡lyGyÅ‘r, Hungary, 9024|Boston, Massachusetts, United States, 02215|Jerusalem, Israel, 9103102 Shaare Zedek Medical CenterJerusalem, Israel, 9103102 Hadassah Medical Center (Ein Kerem)Jerusalem, Israel, 91120|Ancona, An, Italy, 60126 Sod Farmacia-Dipt Dei Servizi -Aou Ospedali Riuniti Umberto I, G.M. Lancisi, G. SalesiTorette Di Ancona, An, Italy, 60126|Cona, Ferrara, Fe, Italy, 44124 Farmacia OspedalieraFerrara, Fe, Italy, 44121|Pesaro, Pu, Italy, 61122|Nagoya, Aichi, Japan, 466-8650|Akita, Japan, 010-8543 Kyushu University HospitalFukuoka, Japan, 812-8582 National Hospital Organization Kumamoto Medical Center[Active, Not Recruiting]Kumamoto, Japan, 860-0008 Nagasaki University HospitalNagasaki, Japan, 852-8501 Tokyo Medical University HospitalTokyo, Japan, 160-0023 Korea, Republic Of, Jeollabuk-Do Chonbuk National University HospitalJeonju-Si, Jeollabuk-Do, Korea, Republic Of, 54907 Korea, Republic Of, Jeollanam-Do Chonnam National University Hwasun HospitalHwasun-Gun, Jeollanam-Do, Korea, Republic Of, 58128 Korea, Republic Of Department Of Pharmacy, Inje University Busan Paik HospitalBusan, Korea, Republic Of, 47392 Inje University Busan Paik HospitalBusan, Korea, Republic Of, 47392 Clinical Trial Pharmacy, Keimyung University Dongsan HospitalDaegu, Korea, Republic Of, 41931 Keimyung University Dongsan HospitalDaegu, Korea, Republic Of, 41931 Gachon University Gil Medical CenterIncheon, Korea, Republic Of, 21565 Seoul National University HospitalSeoul, Korea, Republic Of, 03080 Severance Hospital, Yonsei University Health SystemSeoul, Korea, Republic Of, 03722 Department Of Pharmacy, Samsung Medical CenterSeoul, Korea, Republic Of, 06351 Samsung Medical CenterSeoul, Korea, Republic Of, 06351 The Catholic University Of Korea Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591 The Catholic University Of Korea, Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591|Yoshida-Gun, Fukui, Japan, 910-1193|Maebashi, Gunma, Japan, 371-8511|Kobe-Shi, Hyogo, Japan, 650-0017|Yokohama, Kanagawa, Japan, 232-0024|Sendai, Miyagi, Japan, 980-8574|Osaka-City, Osaka, Japan, 545-8586 Kindai University HospitalOsaka-Sayama, Osaka, Japan, 589-8511|Sunto-Gun, Shizuoka, Japan, 411-8777|Tachikawa, Tokyo, Japan, 190-0014|MÃ©xico, MÃ©x, Mexico, 14080|Gdansk, Poland, 80-214 Wwcoit Im. M. Kopernika W LodziLodz, Poland, 93-513|Cluj-Napoca, Cluj, Romania, 400124|Craiova, Dolj, Romania, 200136|Bucuresti, Romania, 010825 Spitalul Clinic Coltea, Clinica De HematologieBucuresti, Romania, 030171 Russian Federation Sbhi Cch No. 40 Hd MoscowMoscow, Russian Federation, 129301 State Budgetary Healthcare Institution Of MoscowMoscow, Russian Federation, 129301 Sbhi Nnr Nn Rch N. A. N.A. SemashkoNizhniy Novgorod, Russian Federation, 603126 State Budgetary Institution Of Ryazan Region 'Regional Clinical Hospital' (Sbi Rr Rch)Ryazan, Russian Federation, 390039 Fsbi Russrhti Fmba Of|Barcelona, Spain, 08003 Hospital De La Santa Creu I Sant PauBarcelona, Spain, 08025 Hospital Universitario Arnau De VilanovaLleida, Spain, 25198 Hospital General Universitario Gregorio MaranonMadrid, Spain, 28007 Hospital Universitario Ramon Y CajalMadrid, Spain, 28034 Hospital Universitario Virgen Del RocioSevilla, Spain, 41013 Hospital Universitari I Politecnic La FeValencia, Spain, 46026|Orebro, Sweden, 701 85 Universitetssjukhuset OrebroOrebro, Sweden, 701 85 Karolinska Universitetssjukhuset HuddingeStockholm, Sweden, 141 86 Taiwan National Cheng Kung University HospitalTainan, Taiwan, 704 National Taiwan University HospitalTaipei, Taiwan, 100 Department Of Clinical Trial Pharmacy, Taipei Veterans General HospitalTaipei, Taiwan, 11217 Taipei Veterans General HospitalTaipei, Taiwan, 11217 Division Of Pharmacy, Koo Foundation Sun Yat-Sen Cancer CenterTaipei, Taiwan, 112 Koo Foundation Sun Yat-Sen Cancer CenterTaipei, Taiwan, 112 Chang Gung Memorial Hospital-Linkou BranchTaoyuan City, Taiwan, 333 Chemotherapy Pharmacy, Chang Gung Memorial Hospital-Linkou BranchTaoyuan City, Taiwan, 333|Sutton, Surrey, United Kingdom, Sm2 5Pt|London, United Kingdom, Ec1A 7Be Imperial College Healthcare Nhs TrustLondon, United Kingdom, W12 0Hs|Los Angeles, California, United States, 90033 Lac+Usc Medical CenterLos Angeles, California, United States, 90033 Usc/Norris Comprehensive Cancer Center / Investigational Drug ServicesLos Angeles, California, United States, 90033 Usc/Norris Comprehensive Cancer CenterLos Angeles, California, United States, 90033 Rrmc - UclaLos Angeles, California, United States, 90095 Ucla Department Of MedicineLos Angeles, California, United States, 90095 Ucla Hematology/Oncology ClinicLos Angeles, California, United States, 90095 Ucla Ronald Reagan Medical CenterLos Angeles, California, United States, 90095 Keck Medicine Of Usc Norris Oncology/Hematology - Newport Beach Treatment CenterNewport Beach, California, United States, 92663 Usc Norris Oncology/Hematology - Newport BeachNewport Beach, California, United States, 92663 Uc Irvine Health - Chao Family Comprehensive Cancer CenterOrange, California, United States, 92868-3201 Uc Irvine Medical CenterOrange, California, United States, 92868-3201 Ucsf Helen Diller Family Comprehensive Cancer CenterSan Francisco, California, United States, 94143 University Of California, San Francisco Medical CenterSan Francisco, California, United States, 94143 University Of California, San FranciscoSan Francisco, California, United States, 94143|Boston, Massachusetts, United States, 02111 Tufts Medical CenterBoston, Massachusetts, United States, 02111 Massachusetts General HospitalBoston, Massachusetts, United States, 02114 Beth|Kansas City, Missouri, United States, 64132|Lake Success, New York, United States, 11042 North Shore University HospitalManhasset, New York, United States, 11030 Long Island Jewish Medical CenterNew Hyde Park, New York, United States, 11040 University Of Rochester Cancer Center PharmacyRochester, New York, United States, 14642 University Of Rochester Medical CenterRochester, New York, United States, 14642|Cleveland, Ohio, United States, 44106 University Hospitals Cleveland Medical CenterCleveland, Ohio, United States, 44106 Cleveland Clinic FoundationCleveland, Ohio, United States, 44195|Nashville, Tennessee, United States, 37203|Dallas, Texas, United States, 75246 Baylor University Medical CenterDallas, Texas, United States, 75246 Blood Cancer And Stem Cell Transplant ClinicSan Antonio, Texas, United States, 78229 Methodist Healthcare System Of San AntonioSan Antonio, Texas, United States, 78229 Methodist Hospital Investigational PharmacySan Antonio, Texas, United States, 78229|Seattle, Washington, United States, 98104 Swedish Investigational Drug Services PharmacySeattle, Washington, United States, 98104 Swedish Medical CenterSeattle, Washington, United States, 98122","California|Massachusetts|Missouri|New York|Ohio|Tennessee|Texas|Washington","Australia|Austria|Belgium|Canada|China|Czechia|France|Hungary|Israel|Italy|Japan|Mexico|Poland|Romania|Spain|Sweden|United Kingdom|United States","Australia, 5000 Royal Adelaide Hospital|New South Wales St Vincent's Hospital Sydney|Royal Adelaide Hospital - Clinical Trials Pharmacy|Landeskrankenhaus Salzburg, Universitatsklinik Fur Innere Medizin Iii Der Pmu|Az Sint-Jan Brugge - Oostende Av|Manitoba Health Sciences Centre|Ontario Princess Margaret Cancer Centre|Quebec Ciusss De L'Est-De-L'Ile-De- MontrÃ©al - HÃ´pital Maisonneuve-Rosemont|Shandong Affiliated Hospital Of Qingdao University/Hematology Department|Tianjin Institute Of Hematology And Blood Diseases Hospital, Chinese Academy Of Medical Sciences|Zhejiang The First Affiliated Hospital College Of Medicine, Zhejiang University|Interni Hematologicka A Onkologicka Klinika, Fakultni Nemocnice Brno|Chu Henri Mondor|Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Klinika, Hematologia Tanszek|Deaconess Medical Center|Shaare Zedek Medical Canter|An Aou Ospedali Riuniti Umberto I, G.M. Lancisi, G. Salesi, Clinica Di Ematologia|Fe A.O.U. Di Ferrara- Arcispedale Sant'Anna,|Pu Ao Ospedali Riuniti Marche Nord - Presidio Ospedaliero San Salvatore Di Pesaro -|Aichi Japanese Red Cross Nagoya Daini Hospital|Akita University Hospital|Fukui University Of Fukui Hospital|Gunma Gunma University Hospital|Hyogo Kobe University Hospital|Kanagawa Yokohama City University Medical Center|Miyagi Tohoku University Hospital|Osaka Osaka City University Hospital|Shizuoka Shizuoka Cancer Center|Tokyo National Hospital Organization Disaster Medical Center|MÃ©x Instituto Nacional De CancerologÃ­a|Klinika Hematologii I Transplantologii Uniwersyteckie Centrum Kliniczne|Cluj Institutul Oncologic 'Prof. Dr. Ion Chiricuta'|Dolj Spitalul Clinic Municipal Filantropia Craiova, Sectia Clinica Hematologie|Spitalul Universitar De Urgenta Militar Central \"Dr. Carol Davila\" Bucuresti|Hospital Del Mar|Apoex Vn|, Surrey The Royal Marsden Nhs Foundation Trust|Barts Health Nhs Trust|Keck Hospital Of Usc|Tufts Medical Center Investigational Pharmacy|Midamerica Division, Inc., C/O Research Medical Center|Northwell Health/Monter Cancer Center|Taussig Cancer Center Investigational Pharmacy|The Sarah Cannon Research Institute|Baylor Scott And White Research Institute|Swedish Cancer Institute",{"$nulls":3},"Pfizer CT.gov Call Center","2019-05-23","2020-05-25T16:39:34.728","2020-05-26T17:10:42.972","NCT03416179"]
["5ecbf4c7e2561b1b11905eb7","NCT03416179","2019-05-30","Pfizer","PFE","Recruiting","A Study Evaluating Intensive Chemotherapy With or Without Glasdegib or Azacitidine With or Without Glasdegib In Patients With Previously Untreated Acute Myeloid Leukemia (BRIGHT AML1019)","Glasdegib|Cytarabine|Daunorubicin|Azacitidine","Hh Inhibitor|DNA Polymerase Inhibitor|Nucleic Acid Synthesis Inhibitor|TOP2 Inhibitor|DNA Mtase Inhibitor","Unknown",null,"Unknown",null,"Phase 3",4,720,"Anticipated","2018-04-20","2021-06-13","OS","Overall Survival",{"$nulls":3},"Glasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).\n\nGlasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).","Two separate registration trials conducted under one protocol number are proposed to adequately and independently evaluate the addition of glasdegib in intensive and non-intensive chemotherapy populations. Each study will have an experimental treatment arm and a placebo arm. Endpoints are the same for each study except where specifically indicated.\n\nAssignment to the Intensive Study or the Non-Intensive Study will be made by the Investigator based on the 2017 European LeukemiaNet (ELN) recommendations.\n\nStudy B1371019 is a randomized (1:1), double-blind, multi-center, placebo controlled study of chemotherapy in combination with glasdegib versus chemotherapy in combination with placebo in adult patients with previously untreated AML.\n\nGlasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).\n\nGlasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).","A RANDOMIZED (1:1), DOUBLE-BLIND, MULTI-CENTER, PLACEBO CONTROLLED STUDY EVALUATING INTENSIVE CHEMOTHERAPY WITH OR WITHOUT GLASDEGIB (PF-04449913) OR AZACITIDINE (AZA) WITH OR WITHOUT GLASDEGIB IN PATIENTS WITH PREVIOUSLY UNTREATED ACUTE MYELOID LEUKEMIA","B1371019","Leukemia, Myeloid, Acute","Acute Leukemia|Acute Myeloid Leukemia|Myeloid Leukemia|Leukemia","Oncology Hematological","Oncology","Experimental|Placebo Comparator","Arm A (Intensive Study)|Arm B (Intensive Study)|Arm A (Non-intensive study)|Arm B (Non-intensive study)","Glasdegib + '7+3' Induction(s)|Placebo + '7+3' Induction(s)|Glasdegib + azacitidine|Placebo + azacitidine","Drug|Procedure","glasdegib|daunorubicin + cytarabine|cytarabine|HSCT|Placebo|azacitidine","Daily Glasdegib (100 mg, PO), beginning on Day 1 and is to continue up to 2 years post randomization.\n\nFollowing consolidation therapy, glasdegib or placebo will be administered daily for up to 2 years after randomization or until they have minimal residual disease (MRD) negative disease, whichever comes first.\n\nDaily Glasdegib (100 mg, PO) or matching placebo will continue throughout Induction(s) and Consolidation therapies regardless of dose modifications/delays in the chemotherapy.|Consolidation with single agent cytarabine 3 g/m2 IV for adults <60 years and 1 g/m2 for adults 60 years over 3 BID on Days 1, 3, and 5, every 28 days for up to 4 cycles or alternative single agent cytarabine consolidation schedules may be used per local prescribing information.|If required, and done per standard of care post Induction(s).|Azacitidine (75 mg/m2, SC or IV) daily for 7 days, in 28 day cycles for as long as they do not meet the criteria for disease progression, unacceptable toxicity, consent withdrawal, or death.|Matching placebo (PO) is to be administered by mouth daily beginning on Day 1 of chemotherapy and will continue if subjects demonstrate reasonable evidence of clinical benefit and do not meet the criteria for progression regardless of any delays/modifications in the chemotherapy treatment. Subjects will continue placebo until disease progression, unacceptable toxicity, consent withdrawal, or death, whichever comes first.","PF-04449913","Arm A (Intensive Study)|Arm B (Intensive Study)|Arm A (Non-intensive study)|Arm B (Non-intensive study)","\n\nSubjects must meet all of the following inclusion criteria to be eligible for enrollment into the Intensive and Non Intensive study (unless where indicated):\n\n 1.  Subjects with untreated AML according to the World Health Organization (WHO) 2016 Classification2, including those with: * AML arising from MDS or another antecedent hematologic disease (AHD).\n      * AML after previous cytotoxic therapy or radiation (secondary AML).\n     \n     \n 2.  18 years of age (In Japan, 20 years of age).\n 3.  Adequate Organ Function as defined by the following: * Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) 3 x upper limit of normal (ULN), excluding subjects with liver function abnormalities due to underlying malignancy.\n      * Total serum bilirubin 2 x ULN (except subjects with documented Gilbert's syndrome).\n      * Estimated creatinine clearance 30 mL/min as calculated using the standard method for the institution.\n     \n     \n 4.  QTc interval 470 msec using the Fridericia correction (QTcF).\n 5.  All anti cancer treatments (unless specified) should be discontinued 2 weeks from study entry, for example: targeted chemotherapy, radiotherapy, investigational agents, hormones, anagrelide or cytokines. * For control of rapidly progressing leukemia, all trans retinoic acid (ATRA), hydroxyurea, and/or leukopheresis may be used before and for up to 1 week after the first dose of glasdegib.\n     \n     \n 6.  Serum or urine pregnancy test (for female subjects of childbearing potential) with a minimum sensitivity of 25 IU/L or equivalent units of human chorionic gonadotropin (hCG) negative at screening.\n 7.  Male and female subjects of childbearing potential and at risk for pregnancy must agree to use at least one highly effective method of contraception throughout the study and for 180 days after the last dose of azacitidine, cytarabine, or daunorubicin; and the last dose of glasdegib or placebo, whichever occurs later.\n 8.  Female subjects of non childbearing potential must meet at least 1 of the following criteria: 1. Have undergone a documented hysterectomy and/or bilateral oophorectomy;\n      2. Have medically confirmed ovarian failure; or\n      3. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; status may be confirmed by having a serum follicle stimulating hormone (FSH) level confirming the postmenopausal state.\n     \n     All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential.\n     \n     \n 9.  Consent to a saliva sample collection for a germline comparator, unless prohibited by local regulations or ethics committee (EC) decision.\n 10. Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.\n 11. Subjects who are willing and able to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures (including bone marrow [BM] assessments).\n\n","\n\nSubjects with any of the following characteristics/conditions will not be included in the study:\n\n 1.  Acute Promyelocytic Leukemia (APL) and APLwith PML RARA, subjects (WHO 2016 classification).\n 2.  AML with BCR ABL1 or t(9;22)(q34;q11.2) as a sole abnormality. * Complex genetics may include t(9;22) cytogenetic translocation.\n     \n     \n 3.  Subjects with known active CNS leukemia.\n 4.  Participation in other clinical studies involving other investigational drug(s) (Phases 1 4) within 4 weeks prior study entry and/or during study participation.\n 5.  Subjects known to be refractory to platelet or packed red cell transfusions per Institutional Guidelines, or a patient who refuses blood product support.\n 6.  Subjects with another active malignancy on treatment with the exception of basal cell carcinoma, non melanoma skin cancer, cervical carcinoma in situ. Other prior or concurrent malignancies will be considered on a case by case basis.\n 7.  Any one of the following ongoing or in the previous 6 months: myocardial infarction, congenital long QT syndrome, Torsades de pointes, symptomatic arrhythmias (including sustained ventricular tachyarrhythmia), right or left bundle branch block and bifascicular block, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (CHF New York Heart Association class III or IV), cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism; as well as bradycardia defined as <50 bpms.\n 8.  Subjects with an active, life threatening or clinically significant uncontrolled systemic infection not related to AML.\n 9.  Subjects with left ventricular ejection fraction (LVEF) <50% are excluded from the Intensive Chemotherapy Study only.\n 10. Cumulative anthracycline dose equivalent of 550 mg/m2 of daunorubicin for the Intensive Chemotherapy Study only.\n 11. Known malabsorption syndrome or other condition that may significantly impair absorption of study medication in the investigator's judgment (eg, gastrectomy, lap band, Crohn's disease) and inability or unwillingness to swallow tablets or capsules.\n 12. Current use or anticipated requirement for drugs that are known strong CYP3A4/5 inducers.\n 13. Concurrent administration of herbal preparations.\n 14. Major surgery or radiation within 4 weeks of starting study treatment.\n 15. Documented or suspected hypersensitivity to any one of the following: * For subjects assigned to intensive chemotherapy, documented or suspected hypersensitivity to cytarabine (not including drug fever or exanthema, including known cerebellar side effects) or daunorubicin.\n      * For subjects assigned to non intensive chemotherapy, documented or suspected hypersensitivity to azacitidine or mannitol.\n     \n     \n 16. Known active drug or alcohol abuse.\n 17. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.\n 18. Pregnant females or breastfeeding female subjects.\n 19. Known recent or active suicidal ideation or behavior.\n 20. Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.","FSH",null,"Protein","Ovary","Actual","2018-01-31","Actual","Anticipated","2025-07-22","Anticipated","2019-05-01","2017-12-21","2018-01-23","2019-05-28","Yes","glasdegib;\nuntreated;\nHedgehog Inhibitor","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"All",null,"No","Yes\nPfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",null,"URL: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1371019&StudyName=A+Randomized+%281%3A1%29%2C+Double+Blind%2C+Multi+Center%2C+Placebo+Controlled+Study+Evaluating+Intensive+Chemotherapy+With+Or+Without+Glasdegib+%28pf+04449913%29+Or+Azacitidine+%28aza%29+With+Or+Without+Glasdegib+In+Patients+With+Previously+Untreated+Acute+Myeloid+Leukemia [https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1371019&StudyName=A+Randomized+%281%3A1%29%2C+Double+Blind%2C+Multi+Center%2C+Placebo+Controlled+Study+Evaluating+Intensive+Chemotherapy+With+Or+Without+Glasdegib+%28pf+04449913%29+Or+Azacitidine+%28aza%29+With+Or+Without+Glasdegib+In+Patients+With+Previously+Untreated+Acute+Myeloid+Leukemia] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To obtain contact information for a study center near you, click here.",null,"Yes","No",{"$nulls":17},"2017-002822-19|BRIGHT|BRIGHT AML1019","EudraCT Number|Alias Study Number","Overall survival","5 years after last subject randomized",null,"Fatigue score measured by the MD Anderson Symptom Inventory (MDASI)-AML/MDS questionnaire|Rate of Complete Remission (CR) (including CR with minimal residual disease (MRD)-negative as assessed by multiparametric flow cytometry)|Duration of response (defined as CR [includes CR-MRD negative]/CRi or CR/CRh as appropriate)|Time to response (CR[includes CR-MRD negative)]/CR with partial hematologic rcovery (CRh) as appropriate)|Event-free Survival|Patient Reported Outcomes (PROs) as measured by the M.D. Anderson Symptom Inventory AML/MDS Module (MDASI-AML/MDS)|Adverse events as graded by NCI CTCAE v4.03|Laboratory abnormalities as graded by NCI CTCAE v4.03|For the intensive study, the plasma trough concentration (Ctrough) will be analyzed|QTc interval|PROs as measured by Patient Global Impression of Change (PGIC)|Patient Reported Outcomes (PROs) as measured by EuroQoL 5 Dimension questionnaire 5-Level version (EQ-5D-5L)|Patient Reported Outcomes (PROs) as measured by Patient Global Impression of Symptoms (PGIS)|Complete Remission with incomplete hematologic recovery (CRi)|Rate of morphological leukemia-free state (MLFS)|Rate of Partial Remission (PR)|Rate of Complete Remission with partial hematological recovery (CRh) for the Non-intensive study only only|Minimum Observed Plasma Trough Concentratrion of glasdegib in the Intensive Study|Minimum Observed Plasma Trough Concentration of glasdegib in the Non-intensive study","Scale is from 0-10 where 0 is not present and 10 is as bad as you can image.|Response as defined by the 2017 European LeukemiaNet (ELN) recommendations.|5 years after last subject randomized, consent withdrawal, or death|Measurement Scale from 0-10.|PK samples taken on Induction(s) Day 1 (1 and 4 hours post induction); Induction(s) Day 10 (pre-dose, 1 and 4 hours post dose); Day 1 of each Consolidation cycle (pre-dose, 1 and 4 hours post dose)|One question asking for description of leukemia symptoms.|Series of questions that ask for information that best describes health.|One question asking for information regarding leukemia symptoms.|Its the minimum trough concentration in plasma of glasdegib following multiple daily dosing to steady state.|It is the minimum trough concentration in plasma of glasdegib following multiple daily dosing to steady state.","5 years after last subject randomized, consent withdrawal, or death|2 years after last dose of study therapy|5 years after last patient randomized, withdrawal, or death|5 years after last subject randomized, withdrawal, or death|Day 10 of Induction Cycle and Day 1 of each Consolidation Cycle|Cycle 1 Day 15 and Cycles 2 and 3 on Day 1","ClinicalTrials.gov_Inquiries@pfizer.com","Pfizer CT.gov Call Center","1-800-718-1021","Adelaide, South|Darlinghurst, New South Wales, Australia, 2010 St George HospitalKogarah, New South Wales, Australia, 2217|Salzburg, Austria, 5020 Uniklinikum Salzburg, Landeskrankenhaus SalzburgSalzburg, Austria, 5020 Sozialmedizinisches Zentrum Sud.Wien, Austria, 1100 Krankenhaus Hietzing Mit Neurologischem Zentrum RosenhugelWien, Austria, I130|Brugge, Belgium, B-8000 Az Sint-Jan Brugge-Oostende AvBrugge, Belgium, B-8000 Universitaire Ziekenhuizen LeuvenLeuven, Belgium, B-3000|Winnipeg, Manitoba, Canada, R3A 1R9 Cancercare ManitobaWinnipeg, Manitoba, Canada, R3E 0V9|Toronto, Ontario, Canada, M4N 3M5 Princess Margaret Cancer CentreToronto, Ontario, Canada, M5G 2M9|Montreal, Quebec, Canada, H1T 2M4|Qingdao, Shandong, China, 266071|Tianjin, Tianjin, China, 300020|Hangzhou, Zhejiang, China, 310003|Brno, Czechia, 100 34 Nemocnicni LekarnaBrno, Czechia, 625 00 InternÃ­ HematologickÃ¡ Klinika, Fakultni Nemocnice KrÃ¡lovskÃ© VinohradyPraha 10, Czechia, 100 34 Ãšstavni LÃ©kÃ¡rnaPraha 10, Czechia, 100 34|Creteil, France, 94010 Chu Henri MondorCrÃ©teil, France, 94010 Chu De NantesNantes Cedex 1, France, 44093 Chu De Nantes Hotel DieuNantes Cedex, France, 44093 Hopital Saint LouisParis, France, 75010 Centre Hospitalier Lyon Sud -Unite De Pharmacie Clinique OncologiquePierre Benite Cedex, France, 69495 Centre Hospitalier Lyon Sud - Service D'HematologiePierre Benite Cedex, France, 69495 Institut Gustave RoussyVillejuif Cedex, France, 94805|Debrecen, Hungary, 4032 Debreceni Egyetem Klinikai Kozpont Belgyogyaszati KlinikaDebrecen, Hungary, 4032 Petz AladÃ¡r Megyei OktatÃ³ KÃ³rhÃ¡z, GyÃ³gyszerÃ©szeti OsztÃ¡lyGyÅ‘r, Hungary, 9024 Petz AladÃ¡r Megyei OktatÃ³ KÃ³rhÃ¡z, Ii. BelgyÃ³gyÃ¡szat- HematolÃ³giai OsztÃ¡lyGyÅ‘r, Hungary, 9024 Somogy Megyei Kaposi Mor Oktato KorhazKaposvar, Hungary, 7400|Boston, Massachusetts, United States, 02215|Jerusalem, Israel, 9103102 Shaare Zedek Medical CenterJerusalem, Israel, 9103102 Hadassah Medical Center (Ein Kerem)Jerusalem, Israel, 91120|Ancona, An, Italy, 60126 Sod Farmacia-Dipt Dei Servizi -Aou Ospedali Riuniti Umberto I, G.M. Lancisi, G. SalesiTorette Di Ancona, An, Italy, 60126|Cona, Ferrara, Fe, Italy, 44124 Farmacia OspedalieraFerrara, Fe, Italy, 44121|Pesaro, Pu, Italy, 61122|Nagoya, Aichi, Japan, 466-8650|Akita, Japan, 010-8543 Kyushu University HospitalFukuoka, Japan, 812-8582 National Hospital Organization Kumamoto Medical Center[Active, Not Recruiting]Kumamoto, Japan, 860-0008 Nagasaki University HospitalNagasaki, Japan, 852-8501 Tokyo Medical University HospitalTokyo, Japan, 160-0023 Korea, Republic Of, Jeollabuk-Do Chonbuk National University HospitalJeonju-Si, Jeollabuk-Do, Korea, Republic Of, 54907 Korea, Republic Of, Jeollanam-Do Chonnam National University Hwasun HospitalHwasun-Gun, Jeollanam-Do, Korea, Republic Of, 58128 Korea, Republic Of Department Of Pharmacy, Inje University Busan Paik HospitalBusan, Korea, Republic Of, 47392 Inje University Busan Paik HospitalBusan, Korea, Republic Of, 47392 Clinical Trial Pharmacy, Keimyung University Dongsan HospitalDaegu, Korea, Republic Of, 41931 Keimyung University Dongsan HospitalDaegu, Korea, Republic Of, 41931 Gachon University Gil Medical CenterIncheon, Korea, Republic Of, 21565 Seoul National University HospitalSeoul, Korea, Republic Of, 03080 Severance Hospital, Yonsei University Health SystemSeoul, Korea, Republic Of, 03722 Department Of Pharmacy, Samsung Medical CenterSeoul, Korea, Republic Of, 06351 Samsung Medical CenterSeoul, Korea, Republic Of, 06351 The Catholic University Of Korea Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591 The Catholic University Of Korea, Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591|Yoshida-Gun, Fukui, Japan, 910-1193|Maebashi, Gunma, Japan, 371-8511|Kobe-Shi, Hyogo, Japan, 650-0017|Yokohama, Kanagawa, Japan, 232-0024|Sendai, Miyagi, Japan, 980-8574|Osaka-City, Osaka, Japan, 545-8586 Kindai University HospitalOsaka-Sayama, Osaka, Japan, 589-8511|Sunto-Gun, Shizuoka, Japan, 411-8777|Tachikawa, Tokyo, Japan, 190-0014|MÃ©xico, MÃ©x, Mexico, 14080|Gdansk, Poland, 80-214 Wwcoit Im. M. Kopernika W LodziLodz, Poland, 93-513|Cluj-Napoca, Cluj, Romania, 400124|Craiova, Dolj, Romania, 200136|Bucuresti, Romania, 010825 Spitalul Clinic Coltea, Clinica De HematologieBucuresti, Romania, 030171 Russian Federation Sbhi Cch No. 40 Hd MoscowMoscow, Russian Federation, 129301 State Budgetary Healthcare Institution Of MoscowMoscow, Russian Federation, 129301 Sbhi Nnr Nn Rch N. A. N.A. SemashkoNizhniy Novgorod, Russian Federation, 603126 State Budgetary Institution Of Ryazan Region 'Regional Clinical Hospital' (Sbi Rr Rch)Ryazan, Russian Federation, 390039 Fsbi Russrhti Fmba Of|Barcelona, Spain, 08003 Hospital De La Santa Creu I Sant PauBarcelona, Spain, 08025 Hospital Universitario Arnau De VilanovaLleida, Spain, 25198 Hospital General Universitario Gregorio MaranonMadrid, Spain, 28007 Hospital Universitario Ramon Y CajalMadrid, Spain, 28034 Hospital Universitario Virgen Del RocioSevilla, Spain, 41013 Hospital Universitari I Politecnic La FeValencia, Spain, 46026|Orebro, Sweden, 701 85 Universitetssjukhuset OrebroOrebro, Sweden, 701 85 Karolinska Universitetssjukhuset HuddingeStockholm, Sweden, 141 86 Taiwan National Cheng Kung University HospitalTainan, Taiwan, 704 National Taiwan University HospitalTaipei, Taiwan, 100 Department Of Clinical Trial Pharmacy, Taipei Veterans General HospitalTaipei, Taiwan, 11217 Taipei Veterans General HospitalTaipei, Taiwan, 11217 Division Of Pharmacy, Koo Foundation Sun Yat-Sen Cancer CenterTaipei, Taiwan, 112 Koo Foundation Sun Yat-Sen Cancer CenterTaipei, Taiwan, 112 Chang Gung Memorial Hospital-Linkou BranchTaoyuan City, Taiwan, 333 Chemotherapy Pharmacy, Chang Gung Memorial Hospital-Linkou BranchTaoyuan City, Taiwan, 333|Sutton, Surrey, United Kingdom, Sm2 5Pt|London, United Kingdom, Ec1A 7Be Imperial College Healthcare Nhs TrustLondon, United Kingdom, W12 0Hs|Los Angeles, California, United States, 90033 Lac+Usc Medical CenterLos Angeles, California, United States, 90033 Usc/Norris Comprehensive Cancer Center / Investigational Drug ServicesLos Angeles, California, United States, 90033 Usc/Norris Comprehensive Cancer CenterLos Angeles, California, United States, 90033 Rrmc - UclaLos Angeles, California, United States, 90095 Ucla Department Of MedicineLos Angeles, California, United States, 90095 Ucla Hematology/Oncology ClinicLos Angeles, California, United States, 90095 Ucla Ronald Reagan Medical CenterLos Angeles, California, United States, 90095 Keck Medicine Of Usc Norris Oncology/Hematology - Newport Beach Treatment CenterNewport Beach, California, United States, 92663 Usc Norris Oncology/Hematology - Newport BeachNewport Beach, California, United States, 92663 Uc Irvine Health - Chao Family Comprehensive Cancer CenterOrange, California, United States, 92868-3201 Uc Irvine Medical CenterOrange, California, United States, 92868-3201 Ucsf Helen Diller Family Comprehensive Cancer CenterSan Francisco, California, United States, 94143 University Of California, San Francisco Medical CenterSan Francisco, California, United States, 94143 University Of California, San FranciscoSan Francisco, California, United States, 94143|Boston, Massachusetts, United States, 02111 Tufts Medical CenterBoston, Massachusetts, United States, 02111 Massachusetts General HospitalBoston, Massachusetts, United States, 02114 Beth|Kansas City, Missouri, United States, 64132|Lake Success, New York, United States, 11042 North Shore University HospitalManhasset, New York, United States, 11030 Long Island Jewish Medical CenterNew Hyde Park, New York, United States, 11040 University Of Rochester Cancer Center PharmacyRochester, New York, United States, 14642 University Of Rochester Medical CenterRochester, New York, United States, 14642|Cleveland, Ohio, United States, 44106 University Hospitals Cleveland Medical CenterCleveland, Ohio, United States, 44106 Cleveland Clinic FoundationCleveland, Ohio, United States, 44195|Nashville, Tennessee, United States, 37203 The Sarah Cannon Research InstituteNashville, Tennessee, United States, 37203|Dallas, Texas, United States, 75246 Baylor University Medical CenterDallas, Texas, United States, 75246 Blood Cancer And Stem Cell Transplant ClinicSan Antonio, Texas, United States, 78229 Methodist Healthcare System Of San AntonioSan Antonio, Texas, United States, 78229 Methodist Hospital Investigational PharmacySan Antonio, Texas, United States, 78229|Seattle, Washington, United States, 98104 Swedish Investigational Drug Services PharmacySeattle, Washington, United States, 98104 Swedish Medical CenterSeattle, Washington, United States, 98122","California|Massachusetts|Missouri|New York|Ohio|Tennessee|Texas|Washington","Australia|Austria|Belgium|Canada|China|Czechia|France|Hungary|Israel|Italy|Japan|Mexico|Poland|Romania|Spain|Sweden|United Kingdom|United States","Australia, 5000 Royal Adelaide Hospital|New South Wales St Vincent's Hospital Sydney|Royal Adelaide Hospital - Clinical Trials Pharmacy|Landeskrankenhaus Salzburg, Universitatsklinik Fur Innere Medizin Iii Der Pmu|Az Sint-Jan Brugge - Oostende Av|Manitoba Health Sciences Centre|Ontario Sunnybrook Research Institute|Quebec Ciusss De L'Est-De-L'Ile-De- MontrÃ©al - HÃ´pital Maisonneuve-Rosemont|Shandong Affiliated Hospital Of Qingdao University/Hematology Department|Tianjin Institute Of Hematology And Blood Diseases Hospital, Chinese Academy Of Medical Sciences|Zhejiang The First Affiliated Hospital College Of Medicine, Zhejiang University|Interni Hematologicka A Onkologicka Klinika, Fakultni Nemocnice Brno|Chu Henri Mondor|Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Klinika, Hematologia Tanszek|Deaconess Medical Center|Shaare Zedek Medical Canter|An Aou Ospedali Riuniti Umberto I, G.M. Lancisi, G. Salesi, Clinica Di Ematologia|Fe A.O.U. Di Ferrara- Arcispedale Sant'Anna,|Pu Ao Ospedali Riuniti Marche Nord - Presidio Ospedaliero San Salvatore Di Pesaro -|Aichi Japanese Red Cross Nagoya Daini Hospital|Akita University Hospital|Fukui University Of Fukui Hospital|Gunma Gunma University Hospital|Hyogo Kobe University Hospital|Kanagawa Yokohama City University Medical Center|Miyagi Tohoku University Hospital|Osaka Osaka City University Hospital|Shizuoka Shizuoka Cancer Center|Tokyo National Hospital Organization Disaster Medical Center|MÃ©x Instituto Nacional De CancerologÃ­a|Klinika Hematologii I Transplantologii Uniwersyteckie Centrum Kliniczne|Cluj Institutul Oncologic 'Prof. Dr. Ion Chiricuta'|Dolj Spitalul Clinic Municipal Filantropia Craiova, Sectia Clinica Hematologie|Spitalul Universitar De Urgenta Militar Central \"Dr. Carol Davila\" Bucuresti|Hospital Del Mar|Apoex Vn|, Surrey The Royal Marsden Nhs Foundation Trust|Barts Health Nhs Trust|Keck Hospital Of Usc|Tufts Medical Center Investigational Pharmacy|Midamerica Division, Inc., C/O Research Medical Center|Northwell Health/Monter Cancer Center|Taussig Cancer Center Investigational Pharmacy|Centennial Medical Center|Baylor Scott And White Research Institute|Swedish Cancer Institute",{"$nulls":3},"Pfizer CT.gov Call Center","2019-05-28","2020-05-25T16:39:35.639","2020-05-26T17:10:42.972","NCT03416179"]
["5ecbf4c7fe30261b1a0483be","NCT03416179","2019-06-18","Pfizer","PFE","Recruiting","A Study Evaluating Intensive Chemotherapy With or Without Glasdegib or Azacitidine With or Without Glasdegib In Patients With Previously Untreated Acute Myeloid Leukemia (BRIGHT AML1019)","Glasdegib|Cytarabine|Daunorubicin|Azacitidine","Hh Inhibitor|DNA Polymerase Inhibitor|Nucleic Acid Synthesis Inhibitor|TOP2 Inhibitor|DNA Mtase Inhibitor","Unknown",null,"Unknown",null,"Phase 3",4,720,"Anticipated","2018-04-20","2021-06-13","OS","Overall Survival",{"$nulls":3},"Glasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).\n\nGlasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).","Two separate registration trials conducted under one protocol number are proposed to adequately and independently evaluate the addition of glasdegib in intensive and non-intensive chemotherapy populations. Each study will have an experimental treatment arm and a placebo arm. Endpoints are the same for each study except where specifically indicated.\n\nAssignment to the Intensive Study or the Non-Intensive Study will be made by the Investigator based on the 2017 European LeukemiaNet (ELN) recommendations.\n\nStudy B1371019 is a randomized (1:1), double-blind, multi-center, placebo controlled study of chemotherapy in combination with glasdegib versus chemotherapy in combination with placebo in adult patients with previously untreated AML.\n\nGlasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).\n\nGlasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).","A RANDOMIZED (1:1), DOUBLE-BLIND, MULTI-CENTER, PLACEBO CONTROLLED STUDY EVALUATING INTENSIVE CHEMOTHERAPY WITH OR WITHOUT GLASDEGIB (PF-04449913) OR AZACITIDINE (AZA) WITH OR WITHOUT GLASDEGIB IN PATIENTS WITH PREVIOUSLY UNTREATED ACUTE MYELOID LEUKEMIA","B1371019","Leukemia, Myeloid, Acute","Acute Leukemia|Acute Myeloid Leukemia|Myeloid Leukemia|Leukemia","Oncology Hematological","Oncology","Experimental|Placebo Comparator","Arm A (Intensive Study)|Arm B (Intensive Study)|Arm A (Non-intensive study)|Arm B (Non-intensive study)","Glasdegib + '7+3' Induction(s)|Placebo + '7+3' Induction(s)|Glasdegib + azacitidine|Placebo + azacitidine","Drug|Procedure","glasdegib|daunorubicin + cytarabine|cytarabine|HSCT|Placebo|azacitidine","Daily Glasdegib (100 mg, PO), beginning on Day 1 and is to continue up to 2 years post randomization.\n\nFollowing consolidation therapy, glasdegib or placebo will be administered daily for up to 2 years after randomization or until they have minimal residual disease (MRD) negative disease, whichever comes first.\n\nDaily Glasdegib (100 mg, PO) or matching placebo will continue throughout Induction(s) and Consolidation therapies regardless of dose modifications/delays in the chemotherapy.|Consolidation with single agent cytarabine 3 g/m2 IV for adults <60 years and 1 g/m2 for adults 60 years over 3 BID on Days 1, 3, and 5, every 28 days for up to 4 cycles or alternative single agent cytarabine consolidation schedules may be used per local prescribing information.|If required, and done per standard of care post Induction(s).|Azacitidine (75 mg/m2, SC or IV) daily for 7 days, in 28 day cycles for as long as they do not meet the criteria for disease progression, unacceptable toxicity, consent withdrawal, or death.|Matching placebo (PO) is to be administered by mouth daily beginning on Day 1 of chemotherapy and will continue if subjects demonstrate reasonable evidence of clinical benefit and do not meet the criteria for progression regardless of any delays/modifications in the chemotherapy treatment. Subjects will continue placebo until disease progression, unacceptable toxicity, consent withdrawal, or death, whichever comes first.","PF-04449913","Arm A (Intensive Study)|Arm B (Intensive Study)|Arm A (Non-intensive study)|Arm B (Non-intensive study)","\n\nSubjects must meet all of the following inclusion criteria to be eligible for enrollment into the Intensive and Non Intensive study (unless where indicated):\n\n 1.  Subjects with untreated AML according to the World Health Organization (WHO) 2016 Classification2, including those with: * AML arising from MDS or another antecedent hematologic disease (AHD).\n      * AML after previous cytotoxic therapy or radiation (secondary AML).\n     \n     \n 2.  18 years of age (In Japan, 20 years of age).\n 3.  Adequate Organ Function as defined by the following: * Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) 3 x upper limit of normal (ULN), excluding subjects with liver function abnormalities due to underlying malignancy.\n      * Total serum bilirubin 2 x ULN (except subjects with documented Gilbert's syndrome).\n      * Estimated creatinine clearance 30 mL/min as calculated using the standard method for the institution.\n     \n     \n 4.  QTc interval 470 msec using the Fridericia correction (QTcF).\n 5.  All anti cancer treatments (unless specified) should be discontinued 2 weeks from study entry, for example: targeted chemotherapy, radiotherapy, investigational agents, hormones, anagrelide or cytokines. * For control of rapidly progressing leukemia, all trans retinoic acid (ATRA), hydroxyurea, and/or leukopheresis may be used before and for up to 1 week after the first dose of glasdegib.\n     \n     \n 6.  Serum or urine pregnancy test (for female subjects of childbearing potential) with a minimum sensitivity of 25 IU/L or equivalent units of human chorionic gonadotropin (hCG) negative at screening.\n 7.  Male and female subjects of childbearing potential and at risk for pregnancy must agree to use at least one highly effective method of contraception throughout the study and for 180 days after the last dose of azacitidine, cytarabine, or daunorubicin; and the last dose of glasdegib or placebo, whichever occurs later.\n 8.  Female subjects of non childbearing potential must meet at least 1 of the following criteria: 1. Have undergone a documented hysterectomy and/or bilateral oophorectomy;\n      2. Have medically confirmed ovarian failure; or\n      3. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; status may be confirmed by having a serum follicle stimulating hormone (FSH) level confirming the postmenopausal state.\n     \n     All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential.\n     \n     \n 9.  Consent to a saliva sample collection for a germline comparator, unless prohibited by local regulations or ethics committee (EC) decision.\n 10. Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.\n 11. Subjects who are willing and able to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures (including bone marrow [BM] assessments).\n\n","\n\nSubjects with any of the following characteristics/conditions will not be included in the study:\n\n 1.  Acute Promyelocytic Leukemia (APL) and APLwith PML RARA, subjects (WHO 2016 classification).\n 2.  AML with BCR ABL1 or t(9;22)(q34;q11.2) as a sole abnormality. * Complex genetics may include t(9;22) cytogenetic translocation.\n     \n     \n 3.  Subjects with known active CNS leukemia.\n 4.  Participation in other clinical studies involving other investigational drug(s) (Phases 1 4) within 4 weeks prior study entry and/or during study participation.\n 5.  Subjects known to be refractory to platelet or packed red cell transfusions per Institutional Guidelines, or a patient who refuses blood product support.\n 6.  Subjects with another active malignancy on treatment with the exception of basal cell carcinoma, non melanoma skin cancer, cervical carcinoma in situ. Other prior or concurrent malignancies will be considered on a case by case basis.\n 7.  Any one of the following ongoing or in the previous 6 months: myocardial infarction, congenital long QT syndrome, Torsades de pointes, symptomatic arrhythmias (including sustained ventricular tachyarrhythmia), right or left bundle branch block and bifascicular block, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (CHF New York Heart Association class III or IV), cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism; as well as bradycardia defined as <50 bpms.\n 8.  Subjects with an active, life threatening or clinically significant uncontrolled systemic infection not related to AML.\n 9.  Subjects with left ventricular ejection fraction (LVEF) <50% are excluded from the Intensive Chemotherapy Study only.\n 10. Cumulative anthracycline dose equivalent of 550 mg/m2 of daunorubicin for the Intensive Chemotherapy Study only.\n 11. Known malabsorption syndrome or other condition that may significantly impair absorption of study medication in the investigator's judgment (eg, gastrectomy, lap band, Crohn's disease) and inability or unwillingness to swallow tablets or capsules.\n 12. Current use or anticipated requirement for drugs that are known strong CYP3A4/5 inducers.\n 13. Concurrent administration of herbal preparations.\n 14. Major surgery or radiation within 4 weeks of starting study treatment.\n 15. Documented or suspected hypersensitivity to any one of the following: * For subjects assigned to intensive chemotherapy, documented or suspected hypersensitivity to cytarabine (not including drug fever or exanthema, including known cerebellar side effects) or daunorubicin.\n      * For subjects assigned to non intensive chemotherapy, documented or suspected hypersensitivity to azacitidine or mannitol.\n     \n     \n 16. Known active drug or alcohol abuse.\n 17. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.\n 18. Pregnant females or breastfeeding female subjects.\n 19. Known recent or active suicidal ideation or behavior.\n 20. Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.","FSH",null,"Protein","Ovary","Actual","2018-01-31","Actual","Anticipated","2025-07-22","Anticipated","2019-06-01","2017-12-21","2018-01-23","2019-06-17","Yes","glasdegib;\nuntreated;\nHedgehog Inhibitor","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"All",null,"No","Yes\nPfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",null,"URL: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1371019&StudyName=A+Randomized+%281%3A1%29%2C+Double+Blind%2C+Multi+Center%2C+Placebo+Controlled+Study+Evaluating+Intensive+Chemotherapy+With+Or+Without+Glasdegib+%28pf+04449913%29+Or+Azacitidine+%28aza%29+With+Or+Without+Glasdegib+In+Patients+With+Previously+Untreated+Acute+Myeloid+Leukemia [https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1371019&StudyName=A+Randomized+%281%3A1%29%2C+Double+Blind%2C+Multi+Center%2C+Placebo+Controlled+Study+Evaluating+Intensive+Chemotherapy+With+Or+Without+Glasdegib+%28pf+04449913%29+Or+Azacitidine+%28aza%29+With+Or+Without+Glasdegib+In+Patients+With+Previously+Untreated+Acute+Myeloid+Leukemia] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To obtain contact information for a study center near you, click here.",null,"Yes","No",{"$nulls":17},"2017-002822-19|BRIGHT|BRIGHT AML1019","EudraCT Number|Alias Study Number","Overall survival","5 years after last subject randomized",null,"Fatigue score measured by the MD Anderson Symptom Inventory (MDASI)-AML/MDS questionnaire|Rate of Complete Remission (CR) (including CR with minimal residual disease (MRD)-negative as assessed by multiparametric flow cytometry)|Duration of response (defined as CR [includes CR-MRD negative]/CRi or CR/CRh as appropriate)|Time to response (CR[includes CR-MRD negative)]/CR with partial hematologic rcovery (CRh) as appropriate)|Event-free Survival|Patient Reported Outcomes (PROs) as measured by the M.D. Anderson Symptom Inventory AML/MDS Module (MDASI-AML/MDS)|Adverse events as graded by NCI CTCAE v4.03|Laboratory abnormalities as graded by NCI CTCAE v4.03|For the intensive study, the plasma trough concentration (Ctrough) will be analyzed|QTc interval|PROs as measured by Patient Global Impression of Change (PGIC)|Patient Reported Outcomes (PROs) as measured by EuroQoL 5 Dimension questionnaire 5-Level version (EQ-5D-5L)|Patient Reported Outcomes (PROs) as measured by Patient Global Impression of Symptoms (PGIS)|Complete Remission with incomplete hematologic recovery (CRi)|Rate of morphological leukemia-free state (MLFS)|Rate of Partial Remission (PR)|Rate of Complete Remission with partial hematological recovery (CRh) for the Non-intensive study only only|Minimum Observed Plasma Trough Concentratrion of glasdegib in the Intensive Study|Minimum Observed Plasma Trough Concentration of glasdegib in the Non-intensive study","Scale is from 0-10 where 0 is not present and 10 is as bad as you can image.|Response as defined by the 2017 European LeukemiaNet (ELN) recommendations.|5 years after last subject randomized, consent withdrawal, or death|Measurement Scale from 0-10.|PK samples taken on Induction(s) Day 1 (1 and 4 hours post induction); Induction(s) Day 10 (pre-dose, 1 and 4 hours post dose); Day 1 of each Consolidation cycle (pre-dose, 1 and 4 hours post dose)|One question asking for description of leukemia symptoms.|Series of questions that ask for information that best describes health.|One question asking for information regarding leukemia symptoms.|Its the minimum trough concentration in plasma of glasdegib following multiple daily dosing to steady state.|It is the minimum trough concentration in plasma of glasdegib following multiple daily dosing to steady state.","5 years after last subject randomized, consent withdrawal, or death|2 years after last dose of study therapy|5 years after last patient randomized, withdrawal, or death|5 years after last subject randomized, withdrawal, or death|Day 10 of Induction Cycle and Day 1 of each Consolidation Cycle|Cycle 1 Day 15 and Cycles 2 and 3 on Day 1","ClinicalTrials.gov_Inquiries@pfizer.com","Pfizer CT.gov Call Center","1-800-718-1021","Adelaide, South|Darlinghurst, New South Wales, Australia, 2010 St George HospitalKogarah, New South Wales, Australia, 2217|Salzburg, Austria, 5020 Uniklinikum Salzburg, Landeskrankenhaus SalzburgSalzburg, Austria, 5020 Sozialmedizinisches Zentrum Sud.Wien, Austria, 1100 Krankenhaus Hietzing Mit Neurologischem Zentrum RosenhugelWien, Austria, 1130|Brugge, Belgium, B-8000 Az Sint-Jan Brugge-Oostende AvBrugge, Belgium, B-8000 Universitaire Ziekenhuizen Brussel (Uz Brussel)Brussels, Belgium, B-1090 Universitaire Ziekenhuizen BrusselBrussels, Belgium, B-1090 Universitaire Ziekenhuizen LeuvenLeuven, Belgium, B-3000|Winnipeg, Manitoba, Canada, R3A 1R9 Cancercare ManitobaWinnipeg, Manitoba, Canada, R3E 0V9|Toronto, Ontario, Canada, M4N 3M5 Princess Margaret Cancer CentreToronto, Ontario, Canada, M5G 2M9|Montreal, Quebec, Canada, H1T 2M4|Guangzhou, Guangdong, China, 510317|Chengdu, Sichuan, China, 610041|Qingdao, Shandong, China, 266071|Tianjin, Tianjin, China, 300020|Hangzhou, Zhejiang, China, 310003|Brno, Czechia, 100 34 Nemocnicni LekarnaBrno, Czechia, 625 00 Ustavni LekarnaOstrava - Poruba, Czechia, 708 52 Klinika HematoonkologieOstrava-Poruba, Czechia, 708 52 InternÃ­ HematologickÃ¡ Klinika, Fakultni Nemocnice KrÃ¡lovskÃ© VinohradyPraha 10, Czechia, 100 34 Ãšstavni LÃ©kÃ¡rnaPraha 10, Czechia, 100 34|Creteil, France, 94010 Chu Henri MondorCrÃ©teil, France, 94010 Chu De NantesNantes Cedex 1, France, 44093 Chu De Nantes Hotel DieuNantes Cedex, France, 44093 Hopital Saint LouisParis, France, 75010 Centre Hospitalier Lyon Sud - Service D'HematologiePierre Benite Cedex, France, 69495 Centre Hospitalier Lyon Sud -Unite De Pharmacie Clinique OncologiquePierre Benite Cedex, France, 69495 Institut Gustave RoussyVillejuif Cedex, France, 94805|Debrecen, Hungary, 4032 Debreceni Egyetem Klinikai Kozpont Belgyogyaszati KlinikaDebrecen, Hungary, 4032 Petz AladÃ¡r Megyei OktatÃ³ KÃ³rhÃ¡z, GyÃ³gyszerÃ©szeti OsztÃ¡lyGyÅ‘r, Hungary, 9024 Petz AladÃ¡r Megyei OktatÃ³ KÃ³rhÃ¡z, Ii. BelgyÃ³gyÃ¡szat- HematolÃ³giai OsztÃ¡lyGyÅ‘r, Hungary, 9024 Somogy Megyei Kaposi Mor Oktato KorhazKaposvar, Hungary, 7400 Szabolcs-Szatmar Bereg Megyei Korhazak Es Egyetemi Oktatokorhaz, Josa Andras Korhaz, HematologiaNyiregyhaza, Hungary, 4400 Szabolcs-Szatmar Bereg Megyei Korhazak Es Egyetemi Oktatokorhaz, Josa Andras Korhaz,Nyiregyhaza, Hungary, 4400|Boston, Massachusetts, United States, 02215|Jerusalem, Israel, 9103102 Shaare Zedek Medical CenterJerusalem, Israel, 9103102 Hadassah Medical Center (Ein Kerem)Jerusalem, Israel, 91120|Torette Di Ancona, An, Italy, 60126|Torrette Di Ancona, Ancona, Italy, 60126|Bologna, Italy, 40138|Cona, Ferrara, Fe, Italy, 44124 Farmacia OspedalieraFerrara, Fe, Italy, 44121|Pesaro, Pu, Italy, 61122|Nagoya, Aichi, Japan, 466-8650|Akita, Japan, 010-8543 Kyushu University HospitalFukuoka, Japan, 812-8582 National Hospital Organization Kumamoto Medical Center[Active, Not Recruiting]Kumamoto, Japan, 860-0008 Nagasaki University HospitalNagasaki, Japan, 852-8501 Tokyo Medical University HospitalTokyo, Japan, 160-0023 Korea, Republic Of, Jeollabuk-Do Chonbuk National University HospitalJeonju-Si, Jeollabuk-Do, Korea, Republic Of, 54907 Korea, Republic Of, Jeollanam-Do Chonnam National University Hwasun HospitalHwasun-Gun, Jeollanam-Do, Korea, Republic Of, 58128 Korea, Republic Of Department Of Pharmacy, Inje University Busan Paik HospitalBusan, Korea, Republic Of, 47392 Inje University Busan Paik HospitalBusan, Korea, Republic Of, 47392 Clinical Trial Pharmacy, Keimyung University Dongsan HospitalDaegu, Korea, Republic Of, 42601 Keimyung University Dongsan HospitalDaegu, Korea, Republic Of, 42601 Gachon University Gil Medical CenterIncheon, Korea, Republic Of, 21565 Seoul National University HospitalSeoul, Korea, Republic Of, 03080 Severance Hospital, Yonsei University Health SystemSeoul, Korea, Republic Of, 03722 Department Of Pharmacy, Samsung Medical CenterSeoul, Korea, Republic Of, 06351 Samsung Medical CenterSeoul, Korea, Republic Of, 06351 The Catholic University Of Korea Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591 The Catholic University Of Korea, Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591|Yoshida-Gun, Fukui, Japan, 910-1193|Maebashi, Gunma, Japan, 371-8511|Kobe-Shi, Hyogo, Japan, 650-0017|Yokohama, Kanagawa, Japan, 232-0024|Sendai, Miyagi, Japan, 980-8574|Osaka-City, Osaka, Japan, 545-8586 Kindai University HospitalOsaka-Sayama, Osaka, Japan, 589-8511|Sunto-Gun, Shizuoka, Japan, 411-8777|Tachikawa, Tokyo, Japan, 190-0014|MÃ©xico, Mexico, 06726|MÃ©xico, MÃ©x, Mexico, 14080|Gdansk, Poland, 80-214 Wwcoit Im. M. Kopernika W LodziLodz, Poland, 93-513|Cluj-Napoca, Cluj, Romania, 400124|Craiova, Dolj, Romania, 200136|Bucuresti, Romania, 010825 Spitalul Clinic Coltea, Clinica De HematologieBucuresti, Romania, 030171 Russian Federation Sbhi Cch No. 40 Hd MoscowMoscow, Russian Federation, 129301 State Budgetary Healthcare Institution Of MoscowMoscow, Russian Federation, 129301 Sbhi Nnr Nn Rch N. A. N.A. SemashkoNizhniy Novgorod, Russian Federation, 603126 State Budgetary Institution Of Ryazan Region 'Regional Clinical Hospital' (Sbi Rr Rch)Ryazan, Russian Federation, 390039 Fsbi Russrhti Fmba Of|Barcelona, Spain, 08003 Hospital De La Santa Creu I Sant PauBarcelona, Spain, 08025 Hospital Universitario Arnau De VilanovaLleida, Spain, 25198 Hospital General Universitario Gregorio MaranonMadrid, Spain, 28007 Hospital Universitario Ramon Y CajalMadrid, Spain, 28034 Hospital Universitario Virgen Del RocioSevilla, Spain, 41013 Hospital Universitari I Politecnic La FeValencia, Spain, 46026|Orebro, Sweden, 701 85 Universitetssjukhuset OrebroOrebro, Sweden, 701 85 Karolinska Universitetssjukhuset HuddingeStockholm, Sweden, 141 86 Taiwan National Cheng Kung University HospitalTainan, Taiwan, 704 National Taiwan University HospitalTaipei, Taiwan, 100 Department Of Clinical Trial Pharmacy, Taipei Veterans General HospitalTaipei, Taiwan, 11217 Taipei Veterans General HospitalTaipei, Taiwan, 11217 Division Of Pharmacy, Koo Foundation Sun Yat-Sen Cancer CenterTaipei, Taiwan, 112 Koo Foundation Sun Yat-Sen Cancer CenterTaipei, Taiwan, 112 Chang Gung Memorial Hospital-Linkou BranchTaoyuan City, Taiwan, 333 Chemotherapy Pharmacy, Chang Gung Memorial Hospital-Linkou BranchTaoyuan City, Taiwan, 333|Sutton, Surrey, United Kingdom, Sm2 5Pt|Birmingham, West Midlands, United Kingdom, B15 2Th University Hospitals Birmingham Nhs Foundation TrustBirmingham, West Midlands, United Kingdom, B30 3Hg|London, United Kingdom, Ec1A 7Be Imperial College Healthcare Nhs TrustLondon, United Kingdom, W12 0Hs|Los Angeles, California, United States, 90033 Lac+Usc Medical CenterLos Angeles, California, United States, 90033 Usc/Norris Comprehensive Cancer Center / Investigational Drug ServicesLos Angeles, California, United States, 90033 Usc/Norris Comprehensive Cancer CenterLos Angeles, California, United States, 90033 Rrmc - UclaLos Angeles, California, United States, 90095 Ucla Department Of MedicineLos Angeles, California, United States, 90095 Ucla Hematology/Oncology ClinicLos Angeles, California, United States, 90095 Ucla Ronald Reagan Medical CenterLos Angeles, California, United States, 90095 Keck Medicine Of Usc Norris Oncology/Hematology - Newport Beach Treatment CenterNewport Beach, California, United States, 92663 Usc Norris Oncology/Hematology - Newport BeachNewport Beach, California, United States, 92663 Uc Irvine Health - Chao Family Comprehensive Cancer CenterOrange, California, United States, 92868-3201 Uc Irvine Medical CenterOrange, California, United States, 92868-3201 Ucsf Helen Diller Family Comprehensive Cancer CenterSan Francisco, California, United States, 94143 University Of California, San Francisco Medical CenterSan Francisco, California, United States, 94143 University Of California, San FranciscoSan Francisco, California, United States, 94143|Boston, Massachusetts, United States, 02111 Tufts Medical CenterBoston, Massachusetts, United States, 02111 Massachusetts General HospitalBoston, Massachusetts, United States, 02114 Beth|Kansas City, Missouri, United States, 64132|Lake Success, New York, United States, 11042 North Shore University HospitalManhasset, New York, United States, 11030 Long Island Jewish Medical CenterNew Hyde Park, New York, United States, 11040 University Of Rochester Cancer Center PharmacyRochester, New York, United States, 14642 University Of Rochester Medical CenterRochester, New York, United States, 14642|Cleveland, Ohio, United States, 44106 University Hospitals Cleveland Medical CenterCleveland, Ohio, United States, 44106 Cleveland Clinic FoundationCleveland, Ohio, United States, 44195|Nashville, Tennessee, United States, 37203 The Sarah Cannon Research InstituteNashville, Tennessee, United States, 37203|Dallas, Texas, United States, 75246 Baylor University Medical CenterDallas, Texas, United States, 75246 The University Of Texas, Md Anderson Cancer CenterHouston, Texas, United States, 77030 Blood Cancer And Stem Cell Transplant ClinicSan Antonio, Texas, United States, 78229 Methodist Healthcare System Of San AntonioSan Antonio, Texas, United States, 78229 Methodist Hospital Investigational PharmacySan Antonio, Texas, United States, 78229|Seattle, Washington, United States, 98104 Swedish Investigational Drug Services PharmacySeattle, Washington, United States, 98104 Swedish Medical CenterSeattle, Washington, United States, 98122","California|Massachusetts|Missouri|New York|Ohio|Tennessee|Texas|Washington","Australia|Austria|Belgium|Canada|China|Czechia|France|Hungary|Israel|Italy|Japan|Mexico|Poland|Romania|Spain|Sweden|United Kingdom|United States","Australia, 5000 Royal Adelaide Hospital|New South Wales St Vincent's Hospital Sydney|Royal Adelaide Hospital - Clinical Trials Pharmacy|Landeskrankenhaus Salzburg, Universitatsklinik Fur Innere Medizin Iii Der Pmu|Az Sint-Jan Brugge - Oostende Av|Manitoba Health Sciences Centre|Ontario Sunnybrook Research Institute|Quebec Ciusss De L'Est-De-L'Ile-De- MontrÃ©al - HÃ´pital Maisonneuve-Rosemont|Guangdong Guangdong Second Provincial General Hospital|Hospital, Sichuan University|Shandong Affiliated Hospital Of Qingdao University/Hematology Department|Tianjin Institute Of Hematology And Blood Diseases Hospital, Chinese Academy Of Medical Sciences|Zhejiang The First Affiliated Hospital College Of Medicine, Zhejiang University|Interni Hematologicka A Onkologicka Klinika, Fakultni Nemocnice Brno|Chu Henri Mondor|Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Klinika, Hematologia Tanszek|Deaconess Medical Center|Shaare Zedek Medical Canter|An Sod Farmacia-Dipt Dei Servizi -Aou Ospedali Riuniti Umberto I, G.M. Lancisi, G. Salesi|Ancona Aou Ospedali Riuniti Umberto I, G.M. Lancisi, G. Salesi, Clinica Di Ematologia|Azienda Ospedaliero Universitaria Di Bologna Policlinico S.Orsola Malpighi|Fe A.O.U. Di Ferrara- Arcispedale Sant'Anna,|Pu Ao Ospedali Riuniti Marche Nord - Presidio Ospedaliero San Salvatore Di Pesaro -|Aichi Japanese Red Cross Nagoya Daini Hospital|Akita University Hospital|Fukui University Of Fukui Hospital|Gunma Gunma University Hospital|Hyogo Kobe University Hospital|Kanagawa Yokohama City University Medical Center|Miyagi Tohoku University Hospital|Osaka Osaka City University Hospital|Shizuoka Shizuoka Cancer Center|Tokyo National Hospital Organization Disaster Medical Center|Hospital General De MÃ©xico Dr. Eduardo Liceaga|MÃ©x Instituto Nacional De CancerologÃ­a|Klinika Hematologii I Transplantologii Uniwersyteckie Centrum Kliniczne|Cluj Institutul Oncologic 'Prof. Dr. Ion Chiricuta'|Dolj Spitalul Clinic Municipal Filantropia Craiova, Sectia Clinica Hematologie|Spitalul Universitar De Urgenta Militar Central \"Dr. Carol Davila\" Bucuresti|Hospital Del Mar|Apoex Vn|, Surrey The Royal Marsden Nhs Foundation Trust|, West Midlands University Hospitals Birmingham Nhs Foundation Trust|Barts Health Nhs Trust|Keck Hospital Of Usc|Tufts Medical Center Investigational Pharmacy|Midamerica Division, Inc., C/O Research Medical Center|Northwell Health/Monter Cancer Center|Taussig Cancer Center Investigational Pharmacy|Centennial Medical Center|Baylor Scott And White Research Institute|Swedish Cancer Institute",{"$nulls":3},"Pfizer CT.gov Call Center","2019-06-17","2020-05-25T16:39:35.641","2020-05-26T17:10:42.972","NCT03416179"]
["5ecbf4c7307e3d1b1f8d9e4f","NCT03416179","2019-07-01","Pfizer","PFE","Recruiting","A Study Evaluating Intensive Chemotherapy With or Without Glasdegib or Azacitidine With or Without Glasdegib In Patients With Previously Untreated Acute Myeloid Leukemia (BRIGHT AML1019)","Glasdegib|Cytarabine|Daunorubicin|Azacitidine","Hh Inhibitor|DNA Polymerase Inhibitor|Nucleic Acid Synthesis Inhibitor|TOP2 Inhibitor|DNA Mtase Inhibitor","Unknown",null,"Unknown",null,"Phase 3",4,720,"Anticipated","2018-04-20","2021-06-13","OS","Overall Survival",{"$nulls":3},"Glasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).\n\nGlasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).","Two separate registration trials conducted under one protocol number are proposed to adequately and independently evaluate the addition of glasdegib in intensive and non-intensive chemotherapy populations. Each study will have an experimental treatment arm and a placebo arm. Endpoints are the same for each study except where specifically indicated.\n\nAssignment to the Intensive Study or the Non-Intensive Study will be made by the Investigator based on the 2017 European LeukemiaNet (ELN) recommendations.\n\nStudy B1371019 is a randomized (1:1), double-blind, multi-center, placebo controlled study of chemotherapy in combination with glasdegib versus chemotherapy in combination with placebo in adult patients with previously untreated AML.\n\nGlasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).\n\nGlasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).","A RANDOMIZED (1:1), DOUBLE-BLIND, MULTI-CENTER, PLACEBO CONTROLLED STUDY EVALUATING INTENSIVE CHEMOTHERAPY WITH OR WITHOUT GLASDEGIB (PF-04449913) OR AZACITIDINE (AZA) WITH OR WITHOUT GLASDEGIB IN PATIENTS WITH PREVIOUSLY UNTREATED ACUTE MYELOID LEUKEMIA","B1371019","Leukemia, Myeloid, Acute","Acute Leukemia|Acute Myeloid Leukemia|Myeloid Leukemia|Leukemia","Oncology Hematological","Oncology","Experimental|Placebo Comparator","Arm A (Intensive Study)|Arm B (Intensive Study)|Arm A (Non-intensive study)|Arm B (Non-intensive study)","Glasdegib + '7+3' Induction(s)|Placebo + '7+3' Induction(s)|Glasdegib + azacitidine|Placebo + azacitidine","Drug|Procedure","glasdegib|daunorubicin + cytarabine|cytarabine|HSCT|Placebo|azacitidine","Daily Glasdegib (100 mg, PO), beginning on Day 1 and is to continue up to 2 years post randomization.\n\nFollowing consolidation therapy, glasdegib or placebo will be administered daily for up to 2 years after randomization or until they have minimal residual disease (MRD) negative disease, whichever comes first.\n\nDaily Glasdegib (100 mg, PO) or matching placebo will continue throughout Induction(s) and Consolidation therapies regardless of dose modifications/delays in the chemotherapy.|Consolidation with single agent cytarabine 3 g/m2 IV for adults <60 years and 1 g/m2 for adults 60 years over 3 BID on Days 1, 3, and 5, every 28 days for up to 4 cycles or alternative single agent cytarabine consolidation schedules may be used per local prescribing information.|If required, and done per standard of care post Induction(s).|Azacitidine (75 mg/m2, SC or IV) daily for 7 days, in 28 day cycles for as long as they do not meet the criteria for disease progression, unacceptable toxicity, consent withdrawal, or death.|Matching placebo (PO) is to be administered by mouth daily beginning on Day 1 of chemotherapy and will continue if subjects demonstrate reasonable evidence of clinical benefit and do not meet the criteria for progression regardless of any delays/modifications in the chemotherapy treatment. Subjects will continue placebo until disease progression, unacceptable toxicity, consent withdrawal, or death, whichever comes first.","PF-04449913","Arm A (Intensive Study)|Arm B (Intensive Study)|Arm A (Non-intensive study)|Arm B (Non-intensive study)","\n\nSubjects must meet all of the following inclusion criteria to be eligible for enrollment into the Intensive and Non Intensive study (unless where indicated):\n\n 1.  Subjects with untreated AML according to the World Health Organization (WHO) 2016 Classification2, including those with: * AML arising from MDS or another antecedent hematologic disease (AHD).\n      * AML after previous cytotoxic therapy or radiation (secondary AML).\n     \n     \n 2.  18 years of age (In Japan, 20 years of age).\n 3.  Adequate Organ Function as defined by the following: * Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) 3 x upper limit of normal (ULN), excluding subjects with liver function abnormalities due to underlying malignancy.\n      * Total serum bilirubin 2 x ULN (except subjects with documented Gilbert's syndrome).\n      * Estimated creatinine clearance 30 mL/min as calculated using the standard method for the institution.\n     \n     \n 4.  QTc interval 470 msec using the Fridericia correction (QTcF).\n 5.  All anti cancer treatments (unless specified) should be discontinued 2 weeks from study entry, for example: targeted chemotherapy, radiotherapy, investigational agents, hormones, anagrelide or cytokines. * For control of rapidly progressing leukemia, all trans retinoic acid (ATRA), hydroxyurea, and/or leukopheresis may be used before and for up to 1 week after the first dose of glasdegib.\n     \n     \n 6.  Serum or urine pregnancy test (for female subjects of childbearing potential) with a minimum sensitivity of 25 IU/L or equivalent units of human chorionic gonadotropin (hCG) negative at screening.\n 7.  Male and female subjects of childbearing potential and at risk for pregnancy must agree to use at least one highly effective method of contraception throughout the study and for 180 days after the last dose of azacitidine, cytarabine, or daunorubicin; and the last dose of glasdegib or placebo, whichever occurs later.\n 8.  Female subjects of non childbearing potential must meet at least 1 of the following criteria: 1. Have undergone a documented hysterectomy and/or bilateral oophorectomy;\n      2. Have medically confirmed ovarian failure; or\n      3. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; status may be confirmed by having a serum follicle stimulating hormone (FSH) level confirming the postmenopausal state.\n     \n     All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential.\n     \n     \n 9.  Consent to a saliva sample collection for a germline comparator, unless prohibited by local regulations or ethics committee (EC) decision.\n 10. Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.\n 11. Subjects who are willing and able to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures (including bone marrow [BM] assessments).\n\n","\n\nSubjects with any of the following characteristics/conditions will not be included in the study:\n\n 1.  Acute Promyelocytic Leukemia (APL) and APLwith PML RARA, subjects (WHO 2016 classification).\n 2.  AML with BCR ABL1 or t(9;22)(q34;q11.2) as a sole abnormality. * Complex genetics may include t(9;22) cytogenetic translocation.\n     \n     \n 3.  Subjects with known active CNS leukemia.\n 4.  Participation in other clinical studies involving other investigational drug(s) (Phases 1 4) within 4 weeks prior study entry and/or during study participation.\n 5.  Subjects known to be refractory to platelet or packed red cell transfusions per Institutional Guidelines, or a patient who refuses blood product support.\n 6.  Subjects with another active malignancy on treatment with the exception of basal cell carcinoma, non melanoma skin cancer, cervical carcinoma in situ. Other prior or concurrent malignancies will be considered on a case by case basis.\n 7.  Any one of the following ongoing or in the previous 6 months: myocardial infarction, congenital long QT syndrome, Torsades de pointes, symptomatic arrhythmias (including sustained ventricular tachyarrhythmia), right or left bundle branch block and bifascicular block, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (CHF New York Heart Association class III or IV), cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism; as well as bradycardia defined as <50 bpms.\n 8.  Subjects with an active, life threatening or clinically significant uncontrolled systemic infection not related to AML.\n 9.  Subjects with left ventricular ejection fraction (LVEF) <50% are excluded from the Intensive Chemotherapy Study only.\n 10. Cumulative anthracycline dose equivalent of 550 mg/m2 of daunorubicin for the Intensive Chemotherapy Study only.\n 11. Known malabsorption syndrome or other condition that may significantly impair absorption of study medication in the investigator's judgment (eg, gastrectomy, lap band, Crohn's disease) and inability or unwillingness to swallow tablets or capsules.\n 12. Current use or anticipated requirement for drugs that are known strong CYP3A4/5 inducers.\n 13. Concurrent administration of herbal preparations.\n 14. Major surgery or radiation within 4 weeks of starting study treatment.\n 15. Documented or suspected hypersensitivity to any one of the following: * For subjects assigned to intensive chemotherapy, documented or suspected hypersensitivity to cytarabine (not including drug fever or exanthema, including known cerebellar side effects) or daunorubicin.\n      * For subjects assigned to non intensive chemotherapy, documented or suspected hypersensitivity to azacitidine or mannitol.\n     \n     \n 16. Known active drug or alcohol abuse.\n 17. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.\n 18. Pregnant females or breastfeeding female subjects.\n 19. Known recent or active suicidal ideation or behavior.\n 20. Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.","FSH",null,"Protein","Ovary","Actual","2018-01-31","Actual","Anticipated","2025-07-22","Anticipated","2019-06-01","2017-12-21","2018-01-23","2019-06-27","Yes","glasdegib;\nuntreated;\nHedgehog Inhibitor","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"All",null,"No","Yes\nPfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",null,"URL: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1371019&StudyName=A+Randomized+%281%3A1%29%2C+Double+Blind%2C+Multi+Center%2C+Placebo+Controlled+Study+Evaluating+Intensive+Chemotherapy+With+Or+Without+Glasdegib+%28pf+04449913%29+Or+Azacitidine+%28aza%29+With+Or+Without+Glasdegib+In+Patients+With+Previously+Untreated+Acute+Myeloid+Leukemia [https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1371019&StudyName=A+Randomized+%281%3A1%29%2C+Double+Blind%2C+Multi+Center%2C+Placebo+Controlled+Study+Evaluating+Intensive+Chemotherapy+With+Or+Without+Glasdegib+%28pf+04449913%29+Or+Azacitidine+%28aza%29+With+Or+Without+Glasdegib+In+Patients+With+Previously+Untreated+Acute+Myeloid+Leukemia] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To obtain contact information for a study center near you, click here.",null,"Yes","No",{"$nulls":17},"2017-002822-19|BRIGHT|BRIGHT AML1019","EudraCT Number|Alias Study Number","Overall survival","5 years after last subject randomized",null,"Fatigue score measured by the MD Anderson Symptom Inventory (MDASI)-AML/MDS questionnaire|Rate of Complete Remission (CR) (including CR with minimal residual disease (MRD)-negative as assessed by multiparametric flow cytometry)|Duration of response (defined as CR [includes CR-MRD negative]/CRi or CR/CRh as appropriate)|Time to response (CR[includes CR-MRD negative)]/CR with partial hematologic rcovery (CRh) as appropriate)|Event-free Survival|Patient Reported Outcomes (PROs) as measured by the M.D. Anderson Symptom Inventory AML/MDS Module (MDASI-AML/MDS)|Adverse events as graded by NCI CTCAE v4.03|Laboratory abnormalities as graded by NCI CTCAE v4.03|For the intensive study, the plasma trough concentration (Ctrough) will be analyzed|QTc interval|PROs as measured by Patient Global Impression of Change (PGIC)|Patient Reported Outcomes (PROs) as measured by EuroQoL 5 Dimension questionnaire 5-Level version (EQ-5D-5L)|Patient Reported Outcomes (PROs) as measured by Patient Global Impression of Symptoms (PGIS)|Complete Remission with incomplete hematologic recovery (CRi)|Rate of morphological leukemia-free state (MLFS)|Rate of Partial Remission (PR)|Rate of Complete Remission with partial hematological recovery (CRh) for the Non-intensive study only only|Minimum Observed Plasma Trough Concentratrion of glasdegib in the Intensive Study|Minimum Observed Plasma Trough Concentration of glasdegib in the Non-intensive study","Scale is from 0-10 where 0 is not present and 10 is as bad as you can image.|Response as defined by the 2017 European LeukemiaNet (ELN) recommendations.|5 years after last subject randomized, consent withdrawal, or death|Measurement Scale from 0-10.|PK samples taken on Induction(s) Day 1 (1 and 4 hours post induction); Induction(s) Day 10 (pre-dose, 1 and 4 hours post dose); Day 1 of each Consolidation cycle (pre-dose, 1 and 4 hours post dose)|One question asking for description of leukemia symptoms.|Series of questions that ask for information that best describes health.|One question asking for information regarding leukemia symptoms.|Its the minimum trough concentration in plasma of glasdegib following multiple daily dosing to steady state.|It is the minimum trough concentration in plasma of glasdegib following multiple daily dosing to steady state.","5 years after last subject randomized, consent withdrawal, or death|2 years after last dose of study therapy|5 years after last patient randomized, withdrawal, or death|5 years after last subject randomized, withdrawal, or death|Day 10 of Induction Cycle and Day 1 of each Consolidation Cycle|Cycle 1 Day 15 and Cycles 2 and 3 on Day 1","ClinicalTrials.gov_Inquiries@pfizer.com","Pfizer CT.gov Call Center","1-800-718-1021","Adelaide, South|Darlinghurst, New South Wales, Australia, 2010 St George HospitalKogarah, New South Wales, Australia, 2217|Salzburg, Austria, 5020 Uniklinikum Salzburg, Landeskrankenhaus SalzburgSalzburg, Austria, 5020 Sozialmedizinisches Zentrum Sud.Wien, Austria, 1100 Krankenhaus Hietzing Mit Neurologischem Zentrum RosenhugelWien, Austria, 1130|Brugge, Belgium, B-8000 Az Sint-Jan Brugge-Oostende AvBrugge, Belgium, B-8000 Universitaire Ziekenhuizen Brussel (Uz Brussel)Brussels, Belgium, B-1090 Universitaire Ziekenhuizen BrusselBrussels, Belgium, B-1090 Universitaire Ziekenhuizen LeuvenLeuven, Belgium, B-3000|Winnipeg, Manitoba, Canada, R3A 1R9 Cancercare ManitobaWinnipeg, Manitoba, Canada, R3E 0V9|Toronto, Ontario, Canada, M4N 3M5 Princess Margaret Cancer CentreToronto, Ontario, Canada, M5G 2M9|Montreal, Quebec, Canada, H1T 2M4|Guangzhou, Guangdong, China, 510317|Chengdu, Sichuan, China, 610041|Qingdao, Shandong, China, 266071|Shanghai, Shanghai, China, 200080|Tianjin, Tianjin, China, 300020|Hangzhou, Zhejiang, China, 310003|Brno, Czechia, 100 34 Nemocnicni LekarnaBrno, Czechia, 625 00 Ustavni LekarnaOstrava - Poruba, Czechia, 708 52 Klinika HematoonkologieOstrava-Poruba, Czechia, 708 52 InternÃ­ HematologickÃ¡ Klinika, Fakultni Nemocnice KrÃ¡lovskÃ© VinohradyPraha 10, Czechia, 100 34 Ãšstavni LÃ©kÃ¡rnaPraha 10, Czechia, 100 34|Creteil, France, 94010 Chu Henri MondorCrÃ©teil, France, 94010 Chu De NantesNantes Cedex 1, France, 44093 Chu De Nantes Hotel DieuNantes Cedex, France, 44093 Hopital Saint LouisParis, France, 75010 Centre Hospitalier Lyon Sud - Service D'HematologiePierre Benite Cedex, France, 69495 Centre Hospitalier Lyon Sud -Unite De Pharmacie Clinique OncologiquePierre Benite Cedex, France, 69495 Institut Gustave RoussyVillejuif Cedex, France, 94805|Debrecen, Hungary, 4032 Debreceni Egyetem Klinikai Kozpont Belgyogyaszati KlinikaDebrecen, Hungary, 4032 Petz AladÃ¡r Megyei OktatÃ³ KÃ³rhÃ¡z, GyÃ³gyszerÃ©szeti OsztÃ¡lyGyÅ‘r, Hungary, 9024 Petz AladÃ¡r Megyei OktatÃ³ KÃ³rhÃ¡z, Ii. BelgyÃ³gyÃ¡szat- HematolÃ³giai OsztÃ¡lyGyÅ‘r, Hungary, 9024 Somogy Megyei Kaposi Mor Oktato KorhazKaposvar, Hungary, 7400 Szabolcs-Szatmar Bereg Megyei Korhazak Es Egyetemi Oktatokorhaz, Josa Andras Korhaz, HematologiaNyiregyhaza, Hungary, 4400 Szabolcs-Szatmar Bereg Megyei Korhazak Es Egyetemi Oktatokorhaz, Josa Andras Korhaz,Nyiregyhaza, Hungary, 4400|Boston, Massachusetts, United States, 02215|Jerusalem, Israel, 9103102 Shaare Zedek Medical CenterJerusalem, Israel, 9103102 Hadassah Medical Center (Ein Kerem)Jerusalem, Israel, 91120|Torette Di Ancona, An, Italy, 60126|Torrette Di Ancona, Ancona, Italy, 60126|Bologna, Italy, 40138|Cona, Ferrara, Fe, Italy, 44124 Farmacia OspedalieraFerrara, Fe, Italy, 44121|Pesaro, Pu, Italy, 61122|Nagoya, Aichi, Japan, 466-8650|Akita, Japan, 010-8543 Kyushu University HospitalFukuoka, Japan, 812-8582 National Hospital Organization Kumamoto Medical Center[Active, Not Recruiting]Kumamoto, Japan, 860-0008 Nagasaki University HospitalNagasaki, Japan, 852-8501 Tokyo Medical University HospitalTokyo, Japan, 160-0023 Korea, Republic Of, Jeollabuk-Do Chonbuk National University HospitalJeonju-Si, Jeollabuk-Do, Korea, Republic Of, 54907 Korea, Republic Of, Jeollanam-Do Chonnam National University Hwasun HospitalHwasun-Gun, Jeollanam-Do, Korea, Republic Of, 58128 Korea, Republic Of Department Of Pharmacy, Inje University Busan Paik HospitalBusan, Korea, Republic Of, 47392 Inje University Busan Paik HospitalBusan, Korea, Republic Of, 47392 Clinical Trial Pharmacy, Keimyung University Dongsan HospitalDaegu, Korea, Republic Of, 42601 Keimyung University Dongsan HospitalDaegu, Korea, Republic Of, 42601 Gachon University Gil Medical CenterIncheon, Korea, Republic Of, 21565 Seoul National University HospitalSeoul, Korea, Republic Of, 03080 Severance Hospital, Yonsei University Health SystemSeoul, Korea, Republic Of, 03722 Department Of Pharmacy, Samsung Medical CenterSeoul, Korea, Republic Of, 06351 Samsung Medical CenterSeoul, Korea, Republic Of, 06351 The Catholic University Of Korea Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591 The Catholic University Of Korea, Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591|Yoshida-Gun, Fukui, Japan, 910-1193|Maebashi, Gunma, Japan, 371-8511|Kobe-Shi, Hyogo, Japan, 650-0017|Yokohama, Kanagawa, Japan, 232-0024|Sendai, Miyagi, Japan, 980-8574|Osaka-City, Osaka, Japan, 545-8586 Kindai University HospitalOsaka-Sayama, Osaka, Japan, 589-8511|Sunto-Gun, Shizuoka, Japan, 411-8777|Tachikawa, Tokyo, Japan, 190-0014|MÃ©xico, Mexico, 06726|MÃ©xico, MÃ©x, Mexico, 14080|Gdansk, Poland, 80-214 Wwcoit Im. M. Kopernika W LodziLodz, Poland, 93-513|Cluj-Napoca, Cluj, Romania, 400124|Craiova, Dolj, Romania, 200136|Bucuresti, Romania, 010825 Spitalul Clinic Coltea, Clinica De HematologieBucuresti, Romania, 030171 Russian Federation Sbhi Cch No. 40 Hd MoscowMoscow, Russian Federation, 129301 State Budgetary Healthcare Institution Of MoscowMoscow, Russian Federation, 129301 Sbhi Nnr Nn Rch N. A. N.A. SemashkoNizhniy Novgorod, Russian Federation, 603126 State Budgetary Institution Of Ryazan Region 'Regional Clinical Hospital' (Sbi Rr Rch)Ryazan, Russian Federation, 390039 Fsbi Russrhti Fmba Of|Barcelona, Spain, 08003 Hospital De La Santa Creu I Sant PauBarcelona, Spain, 08025 Hospital Universitario Arnau De VilanovaLleida, Spain, 25198 Hospital General Universitario Gregorio MaranonMadrid, Spain, 28007 Hospital Universitario Ramon Y CajalMadrid, Spain, 28034 Hospital Universitario Virgen Del RocioSevilla, Spain, 41013 Hospital Universitari I Politecnic La FeValencia, Spain, 46026|Goteborg, Sweden, 413 45 Apl, Apl Sahlgrenska, Kliniska ProvningarGoteborg, Sweden, 413 46 Apoex VnOrebro, Sweden, 701 85 Universitetssjukhuset OrebroOrebro, Sweden, 701 85 Karolinska Universitetssjukhuset HuddingeStockholm, Sweden, 141 86 Taiwan National Cheng Kung University HospitalTainan, Taiwan, 704 National Taiwan University HospitalTaipei, Taiwan, 100 Department Of Clinical Trial Pharmacy, Taipei Veterans General HospitalTaipei, Taiwan, 11217 Taipei Veterans General HospitalTaipei, Taiwan, 11217 Division Of Pharmacy, Koo Foundation Sun Yat-Sen Cancer CenterTaipei, Taiwan, 112 Koo Foundation Sun Yat-Sen Cancer CenterTaipei, Taiwan, 112 Chang Gung Memorial Hospital-Linkou BranchTaoyuan City, Taiwan, 333 Chemotherapy Pharmacy, Chang Gung Memorial Hospital-Linkou BranchTaoyuan City, Taiwan, 333|Sutton, Surrey, United Kingdom, Sm2 5Pt|Birmingham, West Midlands, United Kingdom, B15 2Th University Hospitals Birmingham Nhs Foundation TrustBirmingham, West Midlands, United Kingdom, B30 3Hg|London, United Kingdom, Ec1A 7Be Imperial College Healthcare Nhs TrustLondon, United Kingdom, W12 0Hs|Los Angeles, California, United States, 90033 Lac+Usc Medical CenterLos Angeles, California, United States, 90033 Usc/Norris Comprehensive Cancer Center / Investigational Drug ServicesLos Angeles, California, United States, 90033 Usc/Norris Comprehensive Cancer CenterLos Angeles, California, United States, 90033 Rrmc - UclaLos Angeles, California, United States, 90095 Ucla Department Of MedicineLos Angeles, California, United States, 90095 Ucla Hematology/Oncology ClinicLos Angeles, California, United States, 90095 Ucla Ronald Reagan Medical CenterLos Angeles, California, United States, 90095 Keck Medicine Of Usc Norris Oncology/Hematology - Newport Beach Treatment CenterNewport Beach, California, United States, 92663 Usc Norris Oncology/Hematology - Newport BeachNewport Beach, California, United States, 92663 Uc Irvine Health - Chao Family Comprehensive Cancer CenterOrange, California, United States, 92868-3201 Uc Irvine Medical CenterOrange, California, United States, 92868-3201 Ucsf Helen Diller Family Comprehensive Cancer CenterSan Francisco, California, United States, 94143 University Of California, San Francisco Medical CenterSan Francisco, California, United States, 94143 University Of California, San FranciscoSan Francisco, California, United States, 94143|Boston, Massachusetts, United States, 02111 Tufts Medical CenterBoston, Massachusetts, United States, 02111 Massachusetts General HospitalBoston, Massachusetts, United States, 02114 Beth|Kansas City, Missouri, United States, 64132|Lake Success, New York, United States, 11042 North Shore University HospitalManhasset, New York, United States, 11030 Long Island Jewish Medical CenterNew Hyde Park, New York, United States, 11040 University Of Rochester Cancer Center PharmacyRochester, New York, United States, 14642 University Of Rochester Medical CenterRochester, New York, United States, 14642|Cleveland, Ohio, United States, 44106 University Hospitals Cleveland Medical CenterCleveland, Ohio, United States, 44106 Cleveland Clinic FoundationCleveland, Ohio, United States, 44195|Nashville, Tennessee, United States, 37203 The Sarah Cannon Research InstituteNashville, Tennessee, United States, 37203|Dallas, Texas, United States, 75246 Baylor University Medical CenterDallas, Texas, United States, 75246 The University Of Texas, Md Anderson Cancer CenterHouston, Texas, United States, 77030 Blood Cancer And Stem Cell Transplant ClinicSan Antonio, Texas, United States, 78229 Methodist Healthcare System Of San AntonioSan Antonio, Texas, United States, 78229 Methodist Hospital Investigational PharmacySan Antonio, Texas, United States, 78229|Seattle, Washington, United States, 98104 Swedish Investigational Drug Services PharmacySeattle, Washington, United States, 98104 Swedish Medical CenterSeattle, Washington, United States, 98122","California|Massachusetts|Missouri|New York|Ohio|Tennessee|Texas|Washington","Australia|Austria|Belgium|Canada|China|Czechia|France|Hungary|Israel|Italy|Japan|Mexico|Poland|Romania|Spain|Sweden|United Kingdom|United States","Australia, 5000 Royal Adelaide Hospital|New South Wales St Vincent's Hospital Sydney|Royal Adelaide Hospital - Clinical Trials Pharmacy|Landeskrankenhaus Salzburg, Universitatsklinik Fur Innere Medizin Iii Der Pmu|Az Sint-Jan Brugge - Oostende Av|Manitoba Health Sciences Centre|Ontario Sunnybrook Research Institute|Quebec Ciusss De L'Est-De-L'Ile-De- MontrÃ©al - HÃ´pital Maisonneuve-Rosemont|Guangdong Guangdong Second Provincial General Hospital|Hospital, Sichuan University|Shandong Affiliated Hospital Of Qingdao University/Hematology Department|Shanghai Shanghai General Hospital|Tianjin Institute Of Hematology And Blood Diseases Hospital, Chinese Academy Of Medical Sciences|Zhejiang The First Affiliated Hospital College Of Medicine, Zhejiang University|Interni Hematologicka A Onkologicka Klinika, Fakultni Nemocnice Brno|Chu Henri Mondor|Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Klinika, Hematologia Tanszek|Deaconess Medical Center|Shaare Zedek Medical Canter|An Sod Farmacia-Dipt Dei Servizi -Aou Ospedali Riuniti Umberto I, G.M. Lancisi, G. Salesi|Ancona Aou Ospedali Riuniti Umberto I, G.M. Lancisi, G. Salesi, Clinica Di Ematologia|Azienda Ospedaliero Universitaria Di Bologna Policlinico S.Orsola Malpighi|Fe A.O.U. Di Ferrara- Arcispedale Sant'Anna,|Pu Ao Ospedali Riuniti Marche Nord - Presidio Ospedaliero San Salvatore Di Pesaro -|Aichi Japanese Red Cross Nagoya Daini Hospital|Akita University Hospital|Fukui University Of Fukui Hospital|Gunma Gunma University Hospital|Hyogo Kobe University Hospital|Kanagawa Yokohama City University Medical Center|Miyagi Tohoku University Hospital|Osaka Osaka City University Hospital|Shizuoka Shizuoka Cancer Center|Tokyo National Hospital Organization Disaster Medical Center|Hospital General De MÃ©xico Dr. Eduardo Liceaga|MÃ©x Instituto Nacional De CancerologÃ­a|Klinika Hematologii I Transplantologii Uniwersyteckie Centrum Kliniczne|Cluj Institutul Oncologic 'Prof. Dr. Ion Chiricuta'|Dolj Spitalul Clinic Municipal Filantropia Craiova, Sectia Clinica Hematologie|Spitalul Universitar De Urgenta Militar Central \"Dr. Carol Davila\" Bucuresti|Hospital Del Mar|Sektionen For Hematologi Och Koagulation|, Surrey The Royal Marsden Nhs Foundation Trust|, West Midlands University Hospitals Birmingham Nhs Foundation Trust|Barts Health Nhs Trust|Keck Hospital Of Usc|Tufts Medical Center Investigational Pharmacy|Midamerica Division, Inc., C/O Research Medical Center|Northwell Health/Monter Cancer Center|Taussig Cancer Center Investigational Pharmacy|Centennial Medical Center|Baylor Scott And White Research Institute|Swedish Cancer Institute",{"$nulls":3},"Pfizer CT.gov Call Center","2019-06-27","2020-05-25T16:39:35.650","2020-05-26T17:10:42.972","NCT03416179"]
["5ecbf4c8feab101b155309ed","NCT03416179","2019-07-12","Pfizer","PFE","Recruiting","A Study Evaluating Intensive Chemotherapy With or Without Glasdegib or Azacitidine With or Without Glasdegib In Patients With Previously Untreated Acute Myeloid Leukemia (BRIGHT AML1019)","Glasdegib|Cytarabine|Daunorubicin|Azacitidine","Hh Inhibitor|DNA Polymerase Inhibitor|Nucleic Acid Synthesis Inhibitor|TOP2 Inhibitor|DNA Mtase Inhibitor","Unknown",null,"Unknown",null,"Phase 3",4,720,"Anticipated","2018-04-20","2021-06-13","OS","Overall Survival",{"$nulls":3},"Glasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).\n\nGlasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).","Two separate registration trials conducted under one protocol number are proposed to adequately and independently evaluate the addition of glasdegib in intensive and non-intensive chemotherapy populations. Each study will have an experimental treatment arm and a placebo arm. Endpoints are the same for each study except where specifically indicated.\n\nAssignment to the Intensive Study or the Non-Intensive Study will be made by the Investigator based on the 2017 European LeukemiaNet (ELN) recommendations.\n\nStudy B1371019 is a randomized (1:1), double-blind, multi-center, placebo controlled study of chemotherapy in combination with glasdegib versus chemotherapy in combination with placebo in adult patients with previously untreated AML.\n\nGlasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).\n\nGlasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).","A RANDOMIZED (1:1), DOUBLE-BLIND, MULTI-CENTER, PLACEBO CONTROLLED STUDY EVALUATING INTENSIVE CHEMOTHERAPY WITH OR WITHOUT GLASDEGIB (PF-04449913) OR AZACITIDINE (AZA) WITH OR WITHOUT GLASDEGIB IN PATIENTS WITH PREVIOUSLY UNTREATED ACUTE MYELOID LEUKEMIA","B1371019","Leukemia, Myeloid, Acute","Acute Leukemia|Acute Myeloid Leukemia|Myeloid Leukemia|Leukemia","Oncology Hematological","Oncology","Experimental|Placebo Comparator","Arm A (Intensive Study)|Arm B (Intensive Study)|Arm A (Non-intensive study)|Arm B (Non-intensive study)","Glasdegib + '7+3' Induction(s)|Placebo + '7+3' Induction(s)|Glasdegib + azacitidine|Placebo + azacitidine","Drug|Procedure","glasdegib|daunorubicin + cytarabine|cytarabine|HSCT|Placebo|azacitidine","Daily Glasdegib (100 mg, PO), beginning on Day 1 and is to continue up to 2 years post randomization.\n\nFollowing consolidation therapy, glasdegib or placebo will be administered daily for up to 2 years after randomization or until they have minimal residual disease (MRD) negative disease, whichever comes first.\n\nDaily Glasdegib (100 mg, PO) or matching placebo will continue throughout Induction(s) and Consolidation therapies regardless of dose modifications/delays in the chemotherapy.|Consolidation with single agent cytarabine 3 g/m2 IV for adults <60 years and 1 g/m2 for adults 60 years over 3 BID on Days 1, 3, and 5, every 28 days for up to 4 cycles or alternative single agent cytarabine consolidation schedules may be used per local prescribing information.|If required, and done per standard of care post Induction(s).|Azacitidine (75 mg/m2, SC or IV) daily for 7 days, in 28 day cycles for as long as they do not meet the criteria for disease progression, unacceptable toxicity, consent withdrawal, or death.|Matching placebo (PO) is to be administered by mouth daily beginning on Day 1 of chemotherapy and will continue if subjects demonstrate reasonable evidence of clinical benefit and do not meet the criteria for progression regardless of any delays/modifications in the chemotherapy treatment. Subjects will continue placebo until disease progression, unacceptable toxicity, consent withdrawal, or death, whichever comes first.","PF-04449913","Arm A (Intensive Study)|Arm B (Intensive Study)|Arm A (Non-intensive study)|Arm B (Non-intensive study)","\n\nSubjects must meet all of the following inclusion criteria to be eligible for enrollment into the Intensive and Non Intensive study (unless where indicated):\n\n 1.  Subjects with untreated AML according to the World Health Organization (WHO) 2016 Classification2, including those with: * AML arising from MDS or another antecedent hematologic disease (AHD).\n      * AML after previous cytotoxic therapy or radiation (secondary AML).\n     \n     \n 2.  18 years of age (In Japan, 20 years of age).\n 3.  Adequate Organ Function as defined by the following: * Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) 3 x upper limit of normal (ULN), excluding subjects with liver function abnormalities due to underlying malignancy.\n      * Total serum bilirubin 2 x ULN (except subjects with documented Gilbert's syndrome).\n      * Estimated creatinine clearance 30 mL/min as calculated using the standard method for the institution.\n     \n     \n 4.  QTc interval 470 msec using the Fridericia correction (QTcF).\n 5.  All anti cancer treatments (unless specified) should be discontinued 2 weeks from study entry, for example: targeted chemotherapy, radiotherapy, investigational agents, hormones, anagrelide or cytokines. * For control of rapidly progressing leukemia, all trans retinoic acid (ATRA), hydroxyurea, and/or leukopheresis may be used before and for up to 1 week after the first dose of glasdegib.\n     \n     \n 6.  Serum or urine pregnancy test (for female subjects of childbearing potential) with a minimum sensitivity of 25 IU/L or equivalent units of human chorionic gonadotropin (hCG) negative at screening.\n 7.  Male and female subjects of childbearing potential and at risk for pregnancy must agree to use at least one highly effective method of contraception throughout the study and for 180 days after the last dose of azacitidine, cytarabine, or daunorubicin; and the last dose of glasdegib or placebo, whichever occurs later.\n 8.  Female subjects of non childbearing potential must meet at least 1 of the following criteria: 1. Have undergone a documented hysterectomy and/or bilateral oophorectomy;\n      2. Have medically confirmed ovarian failure; or\n      3. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; status may be confirmed by having a serum follicle stimulating hormone (FSH) level confirming the postmenopausal state.\n     \n     All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential.\n     \n     \n 9.  Consent to a saliva sample collection for a germline comparator, unless prohibited by local regulations or ethics committee (EC) decision.\n 10. Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.\n 11. Subjects who are willing and able to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures (including bone marrow [BM] assessments).\n\n","\n\nSubjects with any of the following characteristics/conditions will not be included in the study:\n\n 1.  Acute Promyelocytic Leukemia (APL) and APLwith PML RARA, subjects (WHO 2016 classification).\n 2.  AML with BCR ABL1 or t(9;22)(q34;q11.2) as a sole abnormality. * Complex genetics may include t(9;22) cytogenetic translocation.\n     \n     \n 3.  Subjects with known active CNS leukemia.\n 4.  Participation in other clinical studies involving other investigational drug(s) (Phases 1 4) within 4 weeks prior study entry and/or during study participation.\n 5.  Subjects known to be refractory to platelet or packed red cell transfusions per Institutional Guidelines, or a patient who refuses blood product support.\n 6.  Subjects with another active malignancy on treatment with the exception of basal cell carcinoma, non melanoma skin cancer, cervical carcinoma in situ. Other prior or concurrent malignancies will be considered on a case by case basis.\n 7.  Any one of the following ongoing or in the previous 6 months: myocardial infarction, congenital long QT syndrome, Torsades de pointes, symptomatic arrhythmias (including sustained ventricular tachyarrhythmia), right or left bundle branch block and bifascicular block, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (CHF New York Heart Association class III or IV), cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism; as well as bradycardia defined as <50 bpms.\n 8.  Subjects with an active, life threatening or clinically significant uncontrolled systemic infection not related to AML.\n 9.  Subjects with left ventricular ejection fraction (LVEF) <50% are excluded from the Intensive Chemotherapy Study only.\n 10. Cumulative anthracycline dose equivalent of 550 mg/m2 of daunorubicin for the Intensive Chemotherapy Study only.\n 11. Known malabsorption syndrome or other condition that may significantly impair absorption of study medication in the investigator's judgment (eg, gastrectomy, lap band, Crohn's disease) and inability or unwillingness to swallow tablets or capsules.\n 12. Current use or anticipated requirement for drugs that are known strong CYP3A4/5 inducers.\n 13. Concurrent administration of herbal preparations.\n 14. Major surgery or radiation within 4 weeks of starting study treatment.\n 15. Documented or suspected hypersensitivity to any one of the following: * For subjects assigned to intensive chemotherapy, documented or suspected hypersensitivity to cytarabine (not including drug fever or exanthema, including known cerebellar side effects) or daunorubicin.\n      * For subjects assigned to non intensive chemotherapy, documented or suspected hypersensitivity to azacitidine or mannitol.\n     \n     \n 16. Known active drug or alcohol abuse.\n 17. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.\n 18. Pregnant females or breastfeeding female subjects.\n 19. Known recent or active suicidal ideation or behavior.\n 20. Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.","FSH",null,"Protein","Ovary","Actual","2018-01-31","Actual","Anticipated","2025-07-22","Anticipated","2019-07-01","2017-12-21","2018-01-23","2019-07-11","Yes","glasdegib;\nuntreated;\nHedgehog Inhibitor","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"All",null,"No","Yes\nPfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",null,"URL: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1371019&StudyName=A+Randomized+%281%3A1%29%2C+Double+Blind%2C+Multi+Center%2C+Placebo+Controlled+Study+Evaluating+Intensive+Chemotherapy+With+Or+Without+Glasdegib+%28pf+04449913%29+Or+Azacitidine+%28aza%29+With+Or+Without+Glasdegib+In+Patients+With+Previously+Untreated+Acute+Myeloid+Leukemia [https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1371019&StudyName=A+Randomized+%281%3A1%29%2C+Double+Blind%2C+Multi+Center%2C+Placebo+Controlled+Study+Evaluating+Intensive+Chemotherapy+With+Or+Without+Glasdegib+%28pf+04449913%29+Or+Azacitidine+%28aza%29+With+Or+Without+Glasdegib+In+Patients+With+Previously+Untreated+Acute+Myeloid+Leukemia] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To obtain contact information for a study center near you, click here.",null,"Yes","No",{"$nulls":17},"2017-002822-19|BRIGHT|BRIGHT AML1019","EudraCT Number|Alias Study Number","Overall survival","5 years after last subject randomized",null,"Fatigue score measured by the MD Anderson Symptom Inventory (MDASI)-AML/MDS questionnaire|Rate of Complete Remission (CR) (including CR with minimal residual disease (MRD)-negative as assessed by multiparametric flow cytometry)|Duration of response (defined as CR [includes CR-MRD negative]/CRi or CR/CRh as appropriate)|Time to response (CR[includes CR-MRD negative)]/CR with partial hematologic rcovery (CRh) as appropriate)|Event-free Survival|Patient Reported Outcomes (PROs) as measured by the M.D. Anderson Symptom Inventory AML/MDS Module (MDASI-AML/MDS)|Adverse events as graded by NCI CTCAE v4.03|Laboratory abnormalities as graded by NCI CTCAE v4.03|For the intensive study, the plasma trough concentration (Ctrough) will be analyzed|QTc interval|PROs as measured by Patient Global Impression of Change (PGIC)|Patient Reported Outcomes (PROs) as measured by EuroQoL 5 Dimension questionnaire 5-Level version (EQ-5D-5L)|Patient Reported Outcomes (PROs) as measured by Patient Global Impression of Symptoms (PGIS)|Complete Remission with incomplete hematologic recovery (CRi)|Rate of morphological leukemia-free state (MLFS)|Rate of Partial Remission (PR)|Rate of Complete Remission with partial hematological recovery (CRh) for the Non-intensive study only only|Minimum Observed Plasma Trough Concentratrion of glasdegib in the Intensive Study|Minimum Observed Plasma Trough Concentration of glasdegib in the Non-intensive study","Scale is from 0-10 where 0 is not present and 10 is as bad as you can image.|Response as defined by the 2017 European LeukemiaNet (ELN) recommendations.|5 years after last subject randomized, consent withdrawal, or death|Measurement Scale from 0-10.|PK samples taken on Induction(s) Day 1 (1 and 4 hours post induction); Induction(s) Day 10 (pre-dose, 1 and 4 hours post dose); Day 1 of each Consolidation cycle (pre-dose, 1 and 4 hours post dose)|One question asking for description of leukemia symptoms.|Series of questions that ask for information that best describes health.|One question asking for information regarding leukemia symptoms.|Its the minimum trough concentration in plasma of glasdegib following multiple daily dosing to steady state.|It is the minimum trough concentration in plasma of glasdegib following multiple daily dosing to steady state.","5 years after last subject randomized, consent withdrawal, or death|2 years after last dose of study therapy|5 years after last patient randomized, withdrawal, or death|5 years after last subject randomized, withdrawal, or death|Day 10 of Induction Cycle and Day 1 of each Consolidation Cycle|Cycle 1 Day 15 and Cycles 2 and 3 on Day 1","ClinicalTrials.gov_Inquiries@pfizer.com","Pfizer CT.gov Call Center","1-800-718-1021","Adelaide, South|Darlinghurst, New South Wales, Australia, 2010 St George HospitalKogarah, New South Wales, Australia, 2217|Wels, Upper|Salzburg, Austria, 5020 Uniklinikum Salzburg, Landeskrankenhaus SalzburgSalzburg, Austria, 5020 Klinikum Wels-Grieskirchen GmbhWels, Austria, 4600 Sozialmedizinisches Zentrum Sud.Wien, Austria, 1100 Krankenhaus Hietzing Mit Neurologischem Zentrum RosenhugelWien, Austria, 1130|Brugge, Belgium, B-8000 Az Sint-Jan Brugge-Oostende AvBrugge, Belgium, B-8000 Universitaire Ziekenhuizen Brussel (Uz Brussel)Brussels, Belgium, B-1090 Universitaire Ziekenhuizen BrusselBrussels, Belgium, B-1090 Universitaire Ziekenhuizen LeuvenLeuven, Belgium, B-3000|Winnipeg, Manitoba, Canada, R3A 1R9 Cancercare ManitobaWinnipeg, Manitoba, Canada, R3E 0V9|Toronto, Ontario, Canada, M4N 3M5 Princess Margaret Cancer CentreToronto, Ontario, Canada, M5G 2M9|Montreal, Quebec, Canada, H1T 2M4|Guangzhou, Guangdong, China, 510317|Zhengzhou, Henan, China, 450008|Chengdu, Sichuan, China, 610041|Qingdao, Shandong, China, 266071|Shanghai, Shanghai, China, 200080|Tianjin, Tianjin, China, 300020|Hangzhou, Zhejiang, China, 310003|Brno, Czechia, 100 34 Nemocnicni LekarnaBrno, Czechia, 625 00 Ustavni LekarnaOstrava - Poruba, Czechia, 708 52 Klinika HematoonkologieOstrava-Poruba, Czechia, 708 52 InternÃ­ HematologickÃ¡ Klinika, Fakultni Nemocnice KrÃ¡lovskÃ© VinohradyPraha 10, Czechia, 100 34 Ãšstavni LÃ©kÃ¡rnaPraha 10, Czechia, 100 34|Creteil, France, 94010 Chu Henri MondorCrÃ©teil, France, 94010 Chu De NantesNantes Cedex 1, France, 44093 Chu De Nantes Hotel DieuNantes Cedex, France, 44093 Hopital Saint LouisParis, France, 75010 Centre Hospitalier Lyon Sud - Service D'HematologiePierre Benite Cedex, France, 69495 Centre Hospitalier Lyon Sud -Unite De Pharmacie Clinique OncologiquePierre Benite Cedex, France, 69495 Institut Gustave RoussyVillejuif Cedex, France, 94805|Debrecen, Hungary, 4032 Debreceni Egyetem Klinikai Kozpont Belgyogyaszati KlinikaDebrecen, Hungary, 4032 Petz AladÃ¡r Megyei OktatÃ³ KÃ³rhÃ¡z, GyÃ³gyszerÃ©szeti OsztÃ¡lyGyÅ‘r, Hungary, 9024 Petz AladÃ¡r Megyei OktatÃ³ KÃ³rhÃ¡z, Ii. BelgyÃ³gyÃ¡szat- HematolÃ³giai OsztÃ¡lyGyÅ‘r, Hungary, 9024 Somogy Megyei Kaposi Mor Oktato KorhazKaposvar, Hungary, 7400 Szabolcs-Szatmar Bereg Megyei Korhazak Es Egyetemi Oktatokorhaz, Josa Andras Korhaz, HematologiaNyiregyhaza, Hungary, 4400 Szabolcs-Szatmar Bereg Megyei Korhazak Es Egyetemi Oktatokorhaz, Josa Andras Korhaz,Nyiregyhaza, Hungary, 4400|Boston, Massachusetts, United States, 02215|Jerusalem, Israel, 9103102 Shaare Zedek Medical CenterJerusalem, Israel, 9103102 Hadassah Medical Center (Ein Kerem)Jerusalem, Israel, 91120|Torette Di Ancona, An, Italy, 60126|Torrette Di Ancona, Ancona, Italy, 60126|Bologna, Italy, 40138|Cona, Ferrara, Fe, Italy, 44124 Farmacia OspedalieraFerrara, Fe, Italy, 44121|Pesaro, Pu, Italy, 61122|Siena, Si, Italy, 53100|Nagoya, Aichi, Japan, 466-8650|Akita, Japan, 010-8543 Kyushu University HospitalFukuoka, Japan, 812-8582 National Hospital Organization Kumamoto Medical Center[Active, Not Recruiting]Kumamoto, Japan, 860-0008 Nagasaki University HospitalNagasaki, Japan, 852-8501 Tokyo Medical University HospitalTokyo, Japan, 160-0023 Korea, Republic Of, Jeollabuk-Do Chonbuk National University HospitalJeonju-Si, Jeollabuk-Do, Korea, Republic Of, 54907 Korea, Republic Of, Jeollanam-Do Chonnam National University Hwasun HospitalHwasun-Gun, Jeollanam-Do, Korea, Republic Of, 58128 Korea, Republic Of Department Of Pharmacy, Inje University Busan Paik HospitalBusan, Korea, Republic Of, 47392 Inje University Busan Paik HospitalBusan, Korea, Republic Of, 47392 Clinical Trial Pharmacy, Keimyung University Dongsan HospitalDaegu, Korea, Republic Of, 42601 Keimyung University Dongsan HospitalDaegu, Korea, Republic Of, 42601 Gachon University Gil Medical CenterIncheon, Korea, Republic Of, 21565 Seoul National University HospitalSeoul, Korea, Republic Of, 03080 Severance Hospital, Yonsei University Health SystemSeoul, Korea, Republic Of, 03722 Department Of Pharmacy, Samsung Medical CenterSeoul, Korea, Republic Of, 06351 Samsung Medical CenterSeoul, Korea, Republic Of, 06351 The Catholic University Of Korea Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591 The Catholic University Of Korea, Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591|Yoshida-Gun, Fukui, Japan, 910-1193|Maebashi, Gunma, Japan, 371-8511|Kobe-Shi, Hyogo, Japan, 650-0017|Yokohama, Kanagawa, Japan, 232-0024|Sendai, Miyagi, Japan, 980-8574|Osaka-City, Osaka, Japan, 545-8586 Kindai University HospitalOsaka-Sayama, Osaka, Japan, 589-8511|Sunto-Gun, Shizuoka, Japan, 411-8777|Tachikawa, Tokyo, Japan, 190-0014|MÃ©xico, Mexico, 06726|MÃ©xico, MÃ©x, Mexico, 14080|Gdansk, Poland, 80-214 Wwcoit Im. M. Kopernika W LodziLodz, Poland, 93-513|Cluj-Napoca, Cluj, Romania, 400124|Craiova, Dolj, Romania, 200136|Bucuresti, Romania, 010825 Spitalul Clinic Coltea, Clinica De HematologieBucuresti, Romania, 030171 Russian Federation Sbhi Cch No. 40 Hd MoscowMoscow, Russian Federation, 129301 State Budgetary Healthcare Institution Of MoscowMoscow, Russian Federation, 129301 Sbhi Nnr Nn Rch N. A. N.A. SemashkoNizhniy Novgorod, Russian Federation, 603126 State Budgetary Institution Of Ryazan Region 'Regional Clinical Hospital' (Sbi Rr Rch)Ryazan, Russian Federation, 390039 Fsbi Russrhti Fmba Of|Barcelona, Spain, 08003 Hospital De La Santa Creu I Sant PauBarcelona, Spain, 08025 Hospital Universitario Arnau De VilanovaLleida, Spain, 25198 Hospital General Universitario Gregorio MaranonMadrid, Spain, 28007 Hospital Universitario Ramon Y CajalMadrid, Spain, 28034 Hospital Universitario Virgen Del RocioSevilla, Spain, 41013 Hospital Universitari I Politecnic La FeValencia, Spain, 46026|Goteborg, Sweden, 413 45 Apl, Apl Sahlgrenska, Kliniska ProvningarGoteborg, Sweden, 413 46 Apoex VnOrebro, Sweden, 701 85 Universitetssjukhuset OrebroOrebro, Sweden, 701 85 Karolinska Universitetssjukhuset HuddingeStockholm, Sweden, 141 86 Taiwan National Cheng Kung University HospitalTainan, Taiwan, 704 National Taiwan University HospitalTaipei, Taiwan, 100 Department Of Clinical Trial Pharmacy, Taipei Veterans General HospitalTaipei, Taiwan, 11217 Taipei Veterans General HospitalTaipei, Taiwan, 11217 Division Of Pharmacy, Koo Foundation Sun Yat-Sen Cancer CenterTaipei, Taiwan, 112 Koo Foundation Sun Yat-Sen Cancer CenterTaipei, Taiwan, 112 Chang Gung Memorial Hospital-Linkou BranchTaoyuan City, Taiwan, 333 Chemotherapy Pharmacy, Chang Gung Memorial Hospital-Linkou BranchTaoyuan City, Taiwan, 333|Sutton, Surrey, United Kingdom, Sm2 5Pt|Birmingham, West Midlands, United Kingdom, B15 2Th University Hospitals Birmingham Nhs Foundation TrustBirmingham, West Midlands, United Kingdom, B30 3Hg|London, United Kingdom, Ec1A 7Be Imperial College Healthcare Nhs TrustLondon, United Kingdom, W12 0Hs|Los Angeles, California, United States, 90033 Lac+Usc Medical CenterLos Angeles, California, United States, 90033 Usc/Norris Comprehensive Cancer Center / Investigational Drug ServicesLos Angeles, California, United States, 90033 Usc/Norris Comprehensive Cancer CenterLos Angeles, California, United States, 90033 Rrmc - UclaLos Angeles, California, United States, 90095 Ucla Department Of MedicineLos Angeles, California, United States, 90095 Ucla Hematology/Oncology ClinicLos Angeles, California, United States, 90095 Ucla Ronald Reagan Medical CenterLos Angeles, California, United States, 90095 Keck Medicine Of Usc Norris Oncology/Hematology - Newport Beach Treatment CenterNewport Beach, California, United States, 92663 Usc Norris Oncology/Hematology - Newport BeachNewport Beach, California, United States, 92663 Uc Irvine Health - Chao Family Comprehensive Cancer CenterOrange, California, United States, 92868-3201 Uc Irvine Medical CenterOrange, California, United States, 92868-3201 Ucsf Helen Diller Family Comprehensive Cancer CenterSan Francisco, California, United States, 94143 University Of California, San Francisco Medical CenterSan Francisco, California, United States, 94143 University Of California, San FranciscoSan Francisco, California, United States, 94143|Boston, Massachusetts, United States, 02111 Tufts Medical CenterBoston, Massachusetts, United States, 02111 Massachusetts General HospitalBoston, Massachusetts, United States, 02114 Beth|Kansas City, Missouri, United States, 64132|Lake Success, New York, United States, 11042 North Shore University HospitalManhasset, New York, United States, 11030 Long Island Jewish Medical CenterNew Hyde Park, New York, United States, 11040 University Of Rochester Cancer Center PharmacyRochester, New York, United States, 14642 University Of Rochester Medical CenterRochester, New York, United States, 14642|Cleveland, Ohio, United States, 44106 University Hospitals Cleveland Medical CenterCleveland, Ohio, United States, 44106 Cleveland Clinic FoundationCleveland, Ohio, United States, 44195|Nashville, Tennessee, United States, 37203 The Sarah Cannon Research InstituteNashville, Tennessee, United States, 37203|Dallas, Texas, United States, 75246 Baylor University Medical CenterDallas, Texas, United States, 75246 The University Of Texas, Md Anderson Cancer CenterHouston, Texas, United States, 77030 Blood Cancer And Stem Cell Transplant ClinicSan Antonio, Texas, United States, 78229 Methodist Healthcare System Of San AntonioSan Antonio, Texas, United States, 78229 Methodist Hospital Investigational PharmacySan Antonio, Texas, United States, 78229|Seattle, Washington, United States, 98104 Swedish Investigational Drug Services PharmacySeattle, Washington, United States, 98104 Swedish Medical CenterSeattle, Washington, United States, 98122","California|Massachusetts|Missouri|New York|Ohio|Tennessee|Texas|Washington","Australia|Austria|Belgium|Canada|China|Czechia|France|Hungary|Israel|Italy|Japan|Mexico|Poland|Romania|Spain|Sweden|United Kingdom|United States","Australia, 5000 Royal Adelaide Hospital|New South Wales St Vincent's Hospital Sydney|Royal Adelaide Hospital - Clinical Trials Pharmacy|Klinikum Wels-Grieskirchen Gmbh|Landeskrankenhaus Salzburg, Universitatsklinik Fur Innere Medizin Iii Der Pmu|Az Sint-Jan Brugge - Oostende Av|Manitoba Health Sciences Centre|Ontario Sunnybrook Research Institute|Quebec Ciusss De L'Est-De-L'Ile-De- MontrÃ©al - HÃ´pital Maisonneuve-Rosemont|Guangdong Guangdong Second Provincial General Hospital|Henan Henan Cancer Hostipal|Hospital, Sichuan University|Shandong Affiliated Hospital Of Qingdao University/Hematology Department|Shanghai Shanghai General Hospital|Tianjin Institute Of Hematology And Blood Diseases Hospital, Chinese Academy Of Medical Sciences|Zhejiang The First Affiliated Hospital College Of Medicine, Zhejiang University|Interni Hematologicka A Onkologicka Klinika, Fakultni Nemocnice Brno|Chu Henri Mondor|Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Klinika, Hematologia Tanszek|Deaconess Medical Center|Shaare Zedek Medical Canter|An Sod Farmacia-Dipt Dei Servizi -Aou Ospedali Riuniti Umberto I, G.M. Lancisi, G. Salesi|Ancona Aou Ospedali Riuniti Umberto I, G.M. Lancisi, G. Salesi, Clinica Di Ematologia|Azienda Ospedaliero Universitaria Di Bologna Policlinico S.Orsola Malpighi|Fe A.O.U. Di Ferrara- Arcispedale Sant'Anna,|Pu Ao Ospedali Riuniti Marche Nord - Presidio Ospedaliero San Salvatore Di Pesaro -|Si Azienda Ospedaliera Universitaria Senese.|Aichi Japanese Red Cross Nagoya Daini Hospital|Akita University Hospital|Fukui University Of Fukui Hospital|Gunma Gunma University Hospital|Hyogo Kobe University Hospital|Kanagawa Yokohama City University Medical Center|Miyagi Tohoku University Hospital|Osaka Osaka City University Hospital|Shizuoka Shizuoka Cancer Center|Tokyo National Hospital Organization Disaster Medical Center|Hospital General De MÃ©xico Dr. Eduardo Liceaga|MÃ©x Instituto Nacional De CancerologÃ­a|Klinika Hematologii I Transplantologii Uniwersyteckie Centrum Kliniczne|Cluj Institutul Oncologic 'Prof. Dr. Ion Chiricuta'|Dolj Spitalul Clinic Municipal Filantropia Craiova, Sectia Clinica Hematologie|Spitalul Universitar De Urgenta Militar Central \"Dr. Carol Davila\" Bucuresti|Hospital Del Mar|Sektionen For Hematologi Och Koagulation|, Surrey The Royal Marsden Nhs Foundation Trust|, West Midlands University Hospitals Birmingham Nhs Foundation Trust|Barts Health Nhs Trust|Keck Hospital Of Usc|Tufts Medical Center Investigational Pharmacy|Midamerica Division, Inc., C/O Research Medical Center|Northwell Health/Monter Cancer Center|Taussig Cancer Center Investigational Pharmacy|Centennial Medical Center|Baylor Scott And White Research Institute|Swedish Cancer Institute",{"$nulls":3},"Pfizer CT.gov Call Center","2019-07-11","2020-05-25T16:39:36.114","2020-05-26T17:10:42.972","NCT03416179"]
["5ecbf4c8307e3d1b1f8d9e51","NCT03416179","2019-07-23","Pfizer","PFE","Recruiting","A Study Evaluating Intensive Chemotherapy With or Without Glasdegib or Azacitidine With or Without Glasdegib In Patients With Previously Untreated Acute Myeloid Leukemia (BRIGHT AML1019)","Glasdegib|Cytarabine|Daunorubicin|Azacitidine","Hh Inhibitor|DNA Polymerase Inhibitor|Nucleic Acid Synthesis Inhibitor|TOP2 Inhibitor|DNA Mtase Inhibitor","Unknown",null,"Unknown",null,"Phase 3",4,720,"Anticipated","2018-04-20","2021-06-13","OS","Overall Survival",{"$nulls":3},"Glasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).\n\nGlasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).","Two separate registration trials conducted under one protocol number are proposed to adequately and independently evaluate the addition of glasdegib in intensive and non-intensive chemotherapy populations. Each study will have an experimental treatment arm and a placebo arm. Endpoints are the same for each study except where specifically indicated.\n\nAssignment to the Intensive Study or the Non-Intensive Study will be made by the Investigator based on the 2017 European LeukemiaNet (ELN) recommendations.\n\nStudy B1371019 is a randomized (1:1), double-blind, multi-center, placebo controlled study of chemotherapy in combination with glasdegib versus chemotherapy in combination with placebo in adult patients with previously untreated AML.\n\nGlasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).\n\nGlasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).","A RANDOMIZED (1:1), DOUBLE-BLIND, MULTI-CENTER, PLACEBO CONTROLLED STUDY EVALUATING INTENSIVE CHEMOTHERAPY WITH OR WITHOUT GLASDEGIB (PF-04449913) OR AZACITIDINE (AZA) WITH OR WITHOUT GLASDEGIB IN PATIENTS WITH PREVIOUSLY UNTREATED ACUTE MYELOID LEUKEMIA","B1371019","Leukemia, Myeloid, Acute","Acute Leukemia|Acute Myeloid Leukemia|Myeloid Leukemia|Leukemia","Oncology Hematological","Oncology","Experimental|Placebo Comparator","Arm A (Intensive Study)|Arm B (Intensive Study)|Arm A (Non-intensive study)|Arm B (Non-intensive study)","Glasdegib + '7+3' Induction(s)|Placebo + '7+3' Induction(s)|Glasdegib + azacitidine|Placebo + azacitidine","Drug|Procedure","glasdegib|daunorubicin + cytarabine|cytarabine|HSCT|Placebo|azacitidine","Daily Glasdegib (100 mg, PO), beginning on Day 1 and is to continue up to 2 years post randomization.\n\nFollowing consolidation therapy, glasdegib or placebo will be administered daily for up to 2 years after randomization or until they have minimal residual disease (MRD) negative disease, whichever comes first.\n\nDaily Glasdegib (100 mg, PO) or matching placebo will continue throughout Induction(s) and Consolidation therapies regardless of dose modifications/delays in the chemotherapy.|Consolidation with single agent cytarabine 3 g/m2 IV for adults <60 years and 1 g/m2 for adults 60 years over 3 BID on Days 1, 3, and 5, every 28 days for up to 4 cycles or alternative single agent cytarabine consolidation schedules may be used per local prescribing information.|If required, and done per standard of care post Induction(s).|Azacitidine (75 mg/m2, SC or IV) daily for 7 days, in 28 day cycles for as long as they do not meet the criteria for disease progression, unacceptable toxicity, consent withdrawal, or death.|Matching placebo (PO) is to be administered by mouth daily beginning on Day 1 of chemotherapy and will continue if subjects demonstrate reasonable evidence of clinical benefit and do not meet the criteria for progression regardless of any delays/modifications in the chemotherapy treatment. Subjects will continue placebo until disease progression, unacceptable toxicity, consent withdrawal, or death, whichever comes first.","PF-04449913","Arm A (Intensive Study)|Arm B (Intensive Study)|Arm A (Non-intensive study)|Arm B (Non-intensive study)","\n\nSubjects must meet all of the following inclusion criteria to be eligible for enrollment into the Intensive and Non Intensive study (unless where indicated):\n\n 1.  Subjects with untreated AML according to the World Health Organization (WHO) 2016 Classification2, including those with: * AML arising from MDS or another antecedent hematologic disease (AHD).\n      * AML after previous cytotoxic therapy or radiation (secondary AML).\n     \n     \n 2.  18 years of age (In Japan, 20 years of age).\n 3.  Adequate Organ Function as defined by the following: * Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) 3 x upper limit of normal (ULN), excluding subjects with liver function abnormalities due to underlying malignancy.\n      * Total serum bilirubin 2 x ULN (except subjects with documented Gilbert's syndrome).\n      * Estimated creatinine clearance 30 mL/min as calculated using the standard method for the institution.\n     \n     \n 4.  QTc interval 470 msec using the Fridericia correction (QTcF).\n 5.  All anti cancer treatments (unless specified) should be discontinued 2 weeks from study entry, for example: targeted chemotherapy, radiotherapy, investigational agents, hormones, anagrelide or cytokines. * For control of rapidly progressing leukemia, all trans retinoic acid (ATRA), hydroxyurea, and/or leukopheresis may be used before and for up to 1 week after the first dose of glasdegib.\n     \n     \n 6.  Serum or urine pregnancy test (for female subjects of childbearing potential) with a minimum sensitivity of 25 IU/L or equivalent units of human chorionic gonadotropin (hCG) negative at screening.\n 7.  Male and female subjects of childbearing potential and at risk for pregnancy must agree to use at least one highly effective method of contraception throughout the study and for 180 days after the last dose of azacitidine, cytarabine, or daunorubicin; and the last dose of glasdegib or placebo, whichever occurs later.\n 8.  Female subjects of non childbearing potential must meet at least 1 of the following criteria: 1. Have undergone a documented hysterectomy and/or bilateral oophorectomy;\n      2. Have medically confirmed ovarian failure; or\n      3. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; status may be confirmed by having a serum follicle stimulating hormone (FSH) level confirming the postmenopausal state.\n     \n     All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential.\n     \n     \n 9.  Consent to a saliva sample collection for a germline comparator, unless prohibited by local regulations or ethics committee (EC) decision.\n 10. Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.\n 11. Subjects who are willing and able to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures (including bone marrow [BM] assessments).\n\n","\n\nSubjects with any of the following characteristics/conditions will not be included in the study:\n\n 1.  Acute Promyelocytic Leukemia (APL) and APLwith PML RARA, subjects (WHO 2016 classification).\n 2.  AML with BCR ABL1 or t(9;22)(q34;q11.2) as a sole abnormality. * Complex genetics may include t(9;22) cytogenetic translocation.\n     \n     \n 3.  Subjects with known active CNS leukemia.\n 4.  Participation in other clinical studies involving other investigational drug(s) (Phases 1 4) within 4 weeks prior study entry and/or during study participation.\n 5.  Subjects known to be refractory to platelet or packed red cell transfusions per Institutional Guidelines, or a patient who refuses blood product support.\n 6.  Subjects with another active malignancy on treatment with the exception of basal cell carcinoma, non melanoma skin cancer, cervical carcinoma in situ. Other prior or concurrent malignancies will be considered on a case by case basis.\n 7.  Any one of the following ongoing or in the previous 6 months: myocardial infarction, congenital long QT syndrome, Torsades de pointes, symptomatic arrhythmias (including sustained ventricular tachyarrhythmia), right or left bundle branch block and bifascicular block, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (CHF New York Heart Association class III or IV), cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism; as well as bradycardia defined as <50 bpms.\n 8.  Subjects with an active, life threatening or clinically significant uncontrolled systemic infection not related to AML.\n 9.  Subjects with left ventricular ejection fraction (LVEF) <50% are excluded from the Intensive Chemotherapy Study only.\n 10. Cumulative anthracycline dose equivalent of 550 mg/m2 of daunorubicin for the Intensive Chemotherapy Study only.\n 11. Known malabsorption syndrome or other condition that may significantly impair absorption of study medication in the investigator's judgment (eg, gastrectomy, lap band, Crohn's disease) and inability or unwillingness to swallow tablets or capsules.\n 12. Current use or anticipated requirement for drugs that are known strong CYP3A4/5 inducers.\n 13. Concurrent administration of herbal preparations.\n 14. Major surgery or radiation within 4 weeks of starting study treatment.\n 15. Documented or suspected hypersensitivity to any one of the following: * For subjects assigned to intensive chemotherapy, documented or suspected hypersensitivity to cytarabine (not including drug fever or exanthema, including known cerebellar side effects) or daunorubicin.\n      * For subjects assigned to non intensive chemotherapy, documented or suspected hypersensitivity to azacitidine or mannitol.\n     \n     \n 16. Known active drug or alcohol abuse.\n 17. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.\n 18. Pregnant females or breastfeeding female subjects.\n 19. Known recent or active suicidal ideation or behavior.\n 20. Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.","FSH",null,"Protein","Ovary","Actual","2018-01-31","Actual","Anticipated","2025-07-22","Anticipated","2019-07-01","2017-12-21","2018-01-23","2019-07-22","Yes","glasdegib;\nuntreated;\nHedgehog Inhibitor","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"All",null,"No","Yes\nPfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",null,"URL: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1371019&StudyName=A+Randomized+%281%3A1%29%2C+Double+Blind%2C+Multi+Center%2C+Placebo+Controlled+Study+Evaluating+Intensive+Chemotherapy+With+Or+Without+Glasdegib+%28pf+04449913%29+Or+Azacitidine+%28aza%29+With+Or+Without+Glasdegib+In+Patients+With+Previously+Untreated+Acute+Myeloid+Leukemia [https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1371019&StudyName=A+Randomized+%281%3A1%29%2C+Double+Blind%2C+Multi+Center%2C+Placebo+Controlled+Study+Evaluating+Intensive+Chemotherapy+With+Or+Without+Glasdegib+%28pf+04449913%29+Or+Azacitidine+%28aza%29+With+Or+Without+Glasdegib+In+Patients+With+Previously+Untreated+Acute+Myeloid+Leukemia] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To obtain contact information for a study center near you, click here.",null,"Yes","No",{"$nulls":17},"2017-002822-19|BRIGHT|BRIGHT AML1019","EudraCT Number|Alias Study Number","Overall survival","5 years after last subject randomized",null,"Fatigue score measured by the MD Anderson Symptom Inventory (MDASI)-AML/MDS questionnaire|Rate of Complete Remission (CR) (including CR with minimal residual disease (MRD)-negative as assessed by multiparametric flow cytometry)|Duration of response (defined as CR [includes CR-MRD negative]/CRi or CR/CRh as appropriate)|Time to response (CR[includes CR-MRD negative)]/CR with partial hematologic rcovery (CRh) as appropriate)|Event-free Survival|Patient Reported Outcomes (PROs) as measured by the M.D. Anderson Symptom Inventory AML/MDS Module (MDASI-AML/MDS)|Adverse events as graded by NCI CTCAE v4.03|Laboratory abnormalities as graded by NCI CTCAE v4.03|For the intensive study, the plasma trough concentration (Ctrough) will be analyzed|QTc interval|PROs as measured by Patient Global Impression of Change (PGIC)|Patient Reported Outcomes (PROs) as measured by EuroQoL 5 Dimension questionnaire 5-Level version (EQ-5D-5L)|Patient Reported Outcomes (PROs) as measured by Patient Global Impression of Symptoms (PGIS)|Complete Remission with incomplete hematologic recovery (CRi)|Rate of morphological leukemia-free state (MLFS)|Rate of Partial Remission (PR)|Rate of Complete Remission with partial hematological recovery (CRh) for the Non-intensive study only only|Minimum Observed Plasma Trough Concentratrion of glasdegib in the Intensive Study|Minimum Observed Plasma Trough Concentration of glasdegib in the Non-intensive study","Scale is from 0-10 where 0 is not present and 10 is as bad as you can image.|Response as defined by the 2017 European LeukemiaNet (ELN) recommendations.|5 years after last subject randomized, consent withdrawal, or death|Measurement Scale from 0-10.|PK samples taken on Induction(s) Day 1 (1 and 4 hours post induction); Induction(s) Day 10 (pre-dose, 1 and 4 hours post dose); Day 1 of each Consolidation cycle (pre-dose, 1 and 4 hours post dose)|One question asking for description of leukemia symptoms.|Series of questions that ask for information that best describes health.|One question asking for information regarding leukemia symptoms.|Its the minimum trough concentration in plasma of glasdegib following multiple daily dosing to steady state.|It is the minimum trough concentration in plasma of glasdegib following multiple daily dosing to steady state.","5 years after last subject randomized, consent withdrawal, or death|2 years after last dose of study therapy|5 years after last patient randomized, withdrawal, or death|5 years after last subject randomized, withdrawal, or death|Day 10 of Induction Cycle and Day 1 of each Consolidation Cycle|Cycle 1 Day 15 and Cycles 2 and 3 on Day 1","ClinicalTrials.gov_Inquiries@pfizer.com","Pfizer CT.gov Call Center","1-800-718-1021","Adelaide, South|Darlinghurst, New South Wales, Australia, 2010 St George HospitalKogarah, New South Wales, Australia, 2217|Wels, Upper|Salzburg, Austria, 5020 Uniklinikum Salzburg, Landeskrankenhaus SalzburgSalzburg, Austria, 5020 Klinikum Wels-Grieskirchen GmbhWels, Austria, 4600 Sozialmedizinisches Zentrum Sud.Wien, Austria, 1100 Krankenhaus Hietzing Mit Neurologischem Zentrum RosenhugelWien, Austria, 1130|Brugge, Belgium, B-8000 Az Sint-Jan Brugge-Oostende AvBrugge, Belgium, B-8000 Universitaire Ziekenhuizen Brussel (Uz Brussel)Brussels, Belgium, B-1090 Universitaire Ziekenhuizen BrusselBrussels, Belgium, B-1090 Universitaire Ziekenhuizen LeuvenLeuven, Belgium, B-3000|Winnipeg, Manitoba, Canada, R3A 1R9 Cancercare ManitobaWinnipeg, Manitoba, Canada, R3E 0V9|Toronto, Ontario, Canada, M4N 3M5 Princess Margaret Cancer CentreToronto, Ontario, Canada, M5G 2M9|Montreal, Quebec, Canada, H1T 2M4|Guangzhou, Guangdong, China, 510317|Zhengzhou, Henan, China, 450008|Chengdu, Sichuan, China, 610041|Nanjing, Jiangsu, China, 210029|Qingdao, Shandong, China, 266071|Shanghai, Shanghai, China, 200080|Tianjin, Tianjin, China, 300020|Hangzhou, Zhejiang, China, 310003|Brno, Czechia, 100 34 Nemocnicni LekarnaBrno, Czechia, 625 00 Ustavni LekarnaOstrava - Poruba, Czechia, 708 52 Klinika HematoonkologieOstrava-Poruba, Czechia, 708 52 InternÃ­ HematologickÃ¡ Klinika, Fakultni Nemocnice KrÃ¡lovskÃ© VinohradyPraha 10, Czechia, 100 34 Ãšstavni LÃ©kÃ¡rnaPraha 10, Czechia, 100 34|Creteil, France, 94010 Chu Henri MondorCrÃ©teil, France, 94010 Chu De NantesNantes Cedex 1, France, 44093 Chu De Nantes Hotel DieuNantes Cedex, France, 44093 Hopital Saint LouisParis, France, 75010 Centre Hospitalier Lyon Sud - Service D'HematologiePierre Benite Cedex, France, 69495 Centre Hospitalier Lyon Sud -Unite De Pharmacie Clinique OncologiquePierre Benite Cedex, France, 69495 Institut Gustave RoussyVillejuif Cedex, France, 94805|Hannover, Germany, 30625|Debrecen, Hungary, 4032 Debreceni Egyetem Klinikai Kozpont Belgyogyaszati KlinikaDebrecen, Hungary, 4032 Petz AladÃ¡r Megyei OktatÃ³ KÃ³rhÃ¡z, GyÃ³gyszerÃ©szeti OsztÃ¡lyGyÅ‘r, Hungary, 9024 Petz AladÃ¡r Megyei OktatÃ³ KÃ³rhÃ¡z, Ii. BelgyÃ³gyÃ¡szat- HematolÃ³giai OsztÃ¡lyGyÅ‘r, Hungary, 9024 Somogy Megyei Kaposi Mor Oktato KorhazKaposvar, Hungary, 7400 Szabolcs-Szatmar Bereg Megyei Korhazak Es Egyetemi Oktatokorhaz, Josa Andras Korhaz, HematologiaNyiregyhaza, Hungary, 4400 Szabolcs-Szatmar Bereg Megyei Korhazak Es Egyetemi Oktatokorhaz, Josa Andras Korhaz,Nyiregyhaza, Hungary, 4400|Boston, Massachusetts, United States, 02215|Haifa, Israel, 3109601 Shaare Zedek Medical CanterJerusalem, Israel, 9103102 Shaare Zedek Medical CenterJerusalem, Israel, 9103102 Hadassah Medical Center (Ein Kerem)Jerusalem, Israel, 91120 Hemato-Oncology Ambulatory ServicePetah Tikva, Israel, 4941492 Hematology Division - Oncology PharmacyPetah Tikva, Israel, 4941492 Rabin Medical Center, Beilinson HospitalPetah Tikva, Israel, 4941492|Torette Di Ancona, An, Italy, 60126|Torrette Di Ancona, Ancona, Italy, 60126|Bologna, Italy, 40138|Cona, Ferrara, Fe, Italy, 44124 Farmacia OspedalieraFerrara, Fe, Italy, 44121|Pesaro, Pu, Italy, 61122|Siena, Si, Italy, 53100|Nagoya, Aichi, Japan, 466-8650|Akita, Japan, 010-8543 Kyushu University HospitalFukuoka, Japan, 812-8582 National Hospital Organization Kumamoto Medical Center[Active, Not Recruiting]Kumamoto, Japan, 860-0008 Nagasaki University HospitalNagasaki, Japan, 852-8501 Tokyo Medical University HospitalTokyo, Japan, 160-0023 Korea, Republic Of, Jeollabuk-Do Chonbuk National University HospitalJeonju-Si, Jeollabuk-Do, Korea, Republic Of, 54907 Korea, Republic Of, Jeollanam-Do Chonnam National University Hwasun HospitalHwasun-Gun, Jeollanam-Do, Korea, Republic Of, 58128 Korea, Republic Of Department Of Pharmacy, Inje University Busan Paik HospitalBusan, Korea, Republic Of, 47392 Inje University Busan Paik HospitalBusan, Korea, Republic Of, 47392 Clinical Trial Pharmacy, Keimyung University Dongsan HospitalDaegu, Korea, Republic Of, 42601 Keimyung University Dongsan HospitalDaegu, Korea, Republic Of, 42601 Gachon University Gil Medical CenterIncheon, Korea, Republic Of, 21565 Seoul National University HospitalSeoul, Korea, Republic Of, 03080 Severance Hospital, Yonsei University Health SystemSeoul, Korea, Republic Of, 03722 Department Of Pharmacy, Samsung Medical CenterSeoul, Korea, Republic Of, 06351 Samsung Medical CenterSeoul, Korea, Republic Of, 06351 The Catholic University Of Korea Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591 The Catholic University Of Korea, Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591|Yoshida-Gun, Fukui, Japan, 910-1193|Maebashi, Gunma, Japan, 371-8511|Kobe-Shi, Hyogo, Japan, 650-0017|Yokohama, Kanagawa, Japan, 232-0024|Sendai, Miyagi, Japan, 980-8574|Osaka-City, Osaka, Japan, 545-8586 Kindai University HospitalOsaka-Sayama, Osaka, Japan, 589-8511|Sunto-Gun, Shizuoka, Japan, 411-8777|Tachikawa, Tokyo, Japan, 190-0014|MÃ©xico, Mexico, 06726|MÃ©xico, MÃ©x, Mexico, 14080|Gdansk, Poland, 80-214 Wwcoit Im. M. Kopernika W LodziLodz, Poland, 93-513|Cluj-Napoca, Cluj, Romania, 400124|Craiova, Dolj, Romania, 200136|Bucuresti, Romania, 010825 Spitalul Clinic Coltea, Clinica De HematologieBucuresti, Romania, 030171 Russian Federation Sbhi Cch No. 40 Hd MoscowMoscow, Russian Federation, 129301 State Budgetary Healthcare Institution Of MoscowMoscow, Russian Federation, 129301 Sbhi Nnr Nn Rch N. A. N.A. SemashkoNizhniy Novgorod, Russian Federation, 603126 State Budgetary Institution Of Ryazan Region 'Regional Clinical Hospital' (Sbi Rr Rch)Ryazan, Russian Federation, 390039 Fsbi Russrhti Fmba Of|Barcelona, Spain, 08003 Hospital De La Santa Creu I Sant PauBarcelona, Spain, 08025 Hospital Universitario Arnau De VilanovaLleida, Spain, 25198 Hospital General Universitario Gregorio MaranonMadrid, Spain, 28007 Hospital Universitario Ramon Y CajalMadrid, Spain, 28034 Hospital Universitario Virgen Del RocioSevilla, Spain, 41013 Hospital Universitari I Politecnic La FeValencia, Spain, 46026|Goteborg, Sweden, 413 45 Apl, Apl Sahlgrenska, Kliniska ProvningarGoteborg, Sweden, 413 46 Apoex VnOrebro, Sweden, 701 85 Universitetssjukhuset OrebroOrebro, Sweden, 701 85 Karolinska Universitetssjukhuset HuddingeStockholm, Sweden, 141 86 Taiwan National Cheng Kung University HospitalTainan, Taiwan, 704 National Taiwan University HospitalTaipei, Taiwan, 100 Department Of Clinical Trial Pharmacy, Taipei Veterans General HospitalTaipei, Taiwan, 11217 Taipei Veterans General HospitalTaipei, Taiwan, 11217 Division Of Pharmacy, Koo Foundation Sun Yat-Sen Cancer CenterTaipei, Taiwan, 112 Koo Foundation Sun Yat-Sen Cancer CenterTaipei, Taiwan, 112 Chang Gung Memorial Hospital-Linkou BranchTaoyuan City, Taiwan, 333 Chemotherapy Pharmacy, Chang Gung Memorial Hospital-Linkou BranchTaoyuan City, Taiwan, 333|Sutton, Surrey, United Kingdom, Sm2 5Pt|Birmingham, West Midlands, United Kingdom, B15 2Th University Hospitals Birmingham Nhs Foundation TrustBirmingham, West Midlands, United Kingdom, B30 3Hg|London, United Kingdom, Ec1A 7Be Imperial College Healthcare Nhs TrustLondon, United Kingdom, W12 0Hs|Los Angeles, California, United States, 90033 Lac+Usc Medical CenterLos Angeles, California, United States, 90033 Usc/Norris Comprehensive Cancer Center / Investigational Drug ServicesLos Angeles, California, United States, 90033 Usc/Norris Comprehensive Cancer CenterLos Angeles, California, United States, 90033 Rrmc - UclaLos Angeles, California, United States, 90095 Ucla Department Of MedicineLos Angeles, California, United States, 90095 Ucla Hematology/Oncology ClinicLos Angeles, California, United States, 90095 Ucla Ronald Reagan Medical CenterLos Angeles, California, United States, 90095 Keck Medicine Of Usc Norris Oncology/Hematology - Newport Beach Treatment CenterNewport Beach, California, United States, 92663 Usc Norris Oncology/Hematology - Newport BeachNewport Beach, California, United States, 92663 Uc Irvine Health - Chao Family Comprehensive Cancer CenterOrange, California, United States, 92868-3201 Uc Irvine Medical CenterOrange, California, United States, 92868-3201 Ucsf Helen Diller Family Comprehensive Cancer CenterSan Francisco, California, United States, 94143 University Of California, San Francisco Medical CenterSan Francisco, California, United States, 94143 University Of California, San FranciscoSan Francisco, California, United States, 94143|Boston, Massachusetts, United States, 02111 Tufts Medical CenterBoston, Massachusetts, United States, 02111 Massachusetts General HospitalBoston, Massachusetts, United States, 02114 Beth|Kansas City, Missouri, United States, 64132|Lake Success, New York, United States, 11042 North Shore University HospitalManhasset, New York, United States, 11030 Long Island Jewish Medical CenterNew Hyde Park, New York, United States, 11040 University Of Rochester Cancer Center PharmacyRochester, New York, United States, 14642 University Of Rochester Medical CenterRochester, New York, United States, 14642|Cleveland, Ohio, United States, 44106 University Hospitals Cleveland Medical CenterCleveland, Ohio, United States, 44106 Cleveland Clinic FoundationCleveland, Ohio, United States, 44195|Nashville, Tennessee, United States, 37203 The Sarah Cannon Research InstituteNashville, Tennessee, United States, 37203|Dallas, Texas, United States, 75246 Baylor University Medical CenterDallas, Texas, United States, 75246 The University Of Texas, Md Anderson Cancer CenterHouston, Texas, United States, 77030 Blood Cancer And Stem Cell Transplant ClinicSan Antonio, Texas, United States, 78229 Methodist Healthcare System Of San AntonioSan Antonio, Texas, United States, 78229 Methodist Hospital Investigational PharmacySan Antonio, Texas, United States, 78229|Seattle, Washington, United States, 98104 Swedish Investigational Drug Services PharmacySeattle, Washington, United States, 98104 Swedish Medical CenterSeattle, Washington, United States, 98122","California|Massachusetts|Missouri|New York|Ohio|Tennessee|Texas|Washington","Australia|Austria|Belgium|Canada|China|Czechia|France|Germany|Hungary|Israel|Italy|Japan|Mexico|Poland|Romania|Spain|Sweden|United Kingdom|United States","Australia, 5000 Royal Adelaide Hospital|New South Wales St Vincent's Hospital Sydney|Royal Adelaide Hospital - Clinical Trials Pharmacy|Klinikum Wels-Grieskirchen Gmbh|Landeskrankenhaus Salzburg, Universitatsklinik Fur Innere Medizin Iii Der Pmu|Az Sint-Jan Brugge - Oostende Av|Manitoba Health Sciences Centre|Ontario Sunnybrook Research Institute|Quebec Ciusss De L'Est-De-L'Ile-De- MontrÃ©al - HÃ´pital Maisonneuve-Rosemont|Guangdong Guangdong Second Provincial General Hospital|Henan Henan Cancer Hostipal|Hospital, Sichuan University|Jiangsu Jiangsu Province Hospital|Shandong Affiliated Hospital Of Qingdao University/Hematology Department|Shanghai Shanghai General Hospital|Tianjin Institute Of Hematology And Blood Diseases Hospital, Chinese Academy Of Medical Sciences|Zhejiang The First Affiliated Hospital College Of Medicine, Zhejiang University|Interni Hematologicka A Onkologicka Klinika, Fakultni Nemocnice Brno|Chu Henri Mondor|Medizinische Hochschule Hannover|Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Klinika, Hematologia Tanszek|Deaconess Medical Center|Rambam Health Care Campus|An Sod Farmacia-Dipt Dei Servizi -Aou Ospedali Riuniti Umberto I, G.M. Lancisi, G. Salesi|Ancona Aou Ospedali Riuniti Umberto I, G.M. Lancisi, G. Salesi, Clinica Di Ematologia|Azienda Ospedaliero Universitaria Di Bologna Policlinico S.Orsola Malpighi|Fe A.O.U. Di Ferrara- Arcispedale Sant'Anna,|Pu Ao Ospedali Riuniti Marche Nord - Presidio Ospedaliero San Salvatore Di Pesaro -|Si Azienda Ospedaliera Universitaria Senese.|Aichi Japanese Red Cross Nagoya Daini Hospital|Akita University Hospital|Fukui University Of Fukui Hospital|Gunma Gunma University Hospital|Hyogo Kobe University Hospital|Kanagawa Yokohama City University Medical Center|Miyagi Tohoku University Hospital|Osaka Osaka City University Hospital|Shizuoka Shizuoka Cancer Center|Tokyo National Hospital Organization Disaster Medical Center|Hospital General De MÃ©xico Dr. Eduardo Liceaga|MÃ©x Instituto Nacional De CancerologÃ­a|Klinika Hematologii I Transplantologii Uniwersyteckie Centrum Kliniczne|Cluj Institutul Oncologic 'Prof. Dr. Ion Chiricuta'|Dolj Spitalul Clinic Municipal Filantropia Craiova, Sectia Clinica Hematologie|Spitalul Universitar De Urgenta Militar Central \"Dr. Carol Davila\" Bucuresti|Hospital Del Mar|Sektionen For Hematologi Och Koagulation|, Surrey The Royal Marsden Nhs Foundation Trust|, West Midlands University Hospitals Birmingham Nhs Foundation Trust|Barts Health Nhs Trust|Keck Hospital Of Usc|Tufts Medical Center Investigational Pharmacy|Midamerica Division, Inc., C/O Research Medical Center|Northwell Health/Monter Cancer Center|Taussig Cancer Center Investigational Pharmacy|Centennial Medical Center|Baylor Scott And White Research Institute|Swedish Cancer Institute",{"$nulls":3},"Pfizer CT.gov Call Center","2019-07-22","2020-05-25T16:39:36.737","2020-05-26T17:10:42.972","NCT03416179"]
["5ecbf4c8e2561b1b11905eb9","NCT03416179","2019-07-29","Pfizer","PFE","Recruiting","A Study Evaluating Intensive Chemotherapy With or Without Glasdegib or Azacitidine With or Without Glasdegib In Patients With Previously Untreated Acute Myeloid Leukemia (BRIGHT AML1019)","Glasdegib|Cytarabine|Daunorubicin|Azacitidine","Hh Inhibitor|DNA Polymerase Inhibitor|Nucleic Acid Synthesis Inhibitor|TOP2 Inhibitor|DNA Mtase Inhibitor","Unknown",null,"Unknown",null,"Phase 3",4,720,"Anticipated","2018-04-20","2021-06-13","OS","Overall Survival",{"$nulls":3},"Glasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).\n\nGlasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).","Two separate registration trials conducted under one protocol number are proposed to adequately and independently evaluate the addition of glasdegib in intensive and non-intensive chemotherapy populations. Each study will have an experimental treatment arm and a placebo arm. Endpoints are the same for each study except where specifically indicated.\n\nAssignment to the Intensive Study or the Non-Intensive Study will be made by the Investigator based on the 2017 European LeukemiaNet (ELN) recommendations.\n\nStudy B1371019 is a randomized (1:1), double-blind, multi-center, placebo controlled study of chemotherapy in combination with glasdegib versus chemotherapy in combination with placebo in adult patients with previously untreated AML.\n\nGlasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).\n\nGlasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).","A RANDOMIZED (1:1), DOUBLE-BLIND, MULTI-CENTER, PLACEBO CONTROLLED STUDY EVALUATING INTENSIVE CHEMOTHERAPY WITH OR WITHOUT GLASDEGIB (PF-04449913) OR AZACITIDINE (AZA) WITH OR WITHOUT GLASDEGIB IN PATIENTS WITH PREVIOUSLY UNTREATED ACUTE MYELOID LEUKEMIA","B1371019","Leukemia, Myeloid, Acute","Acute Leukemia|Acute Myeloid Leukemia|Myeloid Leukemia|Leukemia","Oncology Hematological","Oncology","Experimental|Placebo Comparator","Arm A (Intensive Study)|Arm B (Intensive Study)|Arm A (Non-intensive study)|Arm B (Non-intensive study)","Glasdegib + '7+3' Induction(s)|Placebo + '7+3' Induction(s)|Glasdegib + azacitidine|Placebo + azacitidine","Drug|Procedure","glasdegib|daunorubicin + cytarabine|cytarabine|HSCT|Placebo|azacitidine","Daily Glasdegib (100 mg, PO), beginning on Day 1 and is to continue up to 2 years post randomization.\n\nFollowing consolidation therapy, glasdegib or placebo will be administered daily for up to 2 years after randomization or until they have minimal residual disease (MRD) negative disease, whichever comes first.\n\nDaily Glasdegib (100 mg, PO) or matching placebo will continue throughout Induction(s) and Consolidation therapies regardless of dose modifications/delays in the chemotherapy.|Consolidation with single agent cytarabine 3 g/m2 IV for adults <60 years and 1 g/m2 for adults 60 years over 3 BID on Days 1, 3, and 5, every 28 days for up to 4 cycles or alternative single agent cytarabine consolidation schedules may be used per local prescribing information.|If required, and done per standard of care post Induction(s).|Azacitidine (75 mg/m2, SC or IV) daily for 7 days, in 28 day cycles for as long as they do not meet the criteria for disease progression, unacceptable toxicity, consent withdrawal, or death.|Matching placebo (PO) is to be administered by mouth daily beginning on Day 1 of chemotherapy and will continue if subjects demonstrate reasonable evidence of clinical benefit and do not meet the criteria for progression regardless of any delays/modifications in the chemotherapy treatment. Subjects will continue placebo until disease progression, unacceptable toxicity, consent withdrawal, or death, whichever comes first.","PF-04449913","Arm A (Intensive Study)|Arm B (Intensive Study)|Arm A (Non-intensive study)|Arm B (Non-intensive study)","\n\nSubjects must meet all of the following inclusion criteria to be eligible for enrollment into the Intensive and Non Intensive study (unless where indicated):\n\n 1.  Subjects with untreated AML according to the World Health Organization (WHO) 2016 Classification2, including those with: * AML arising from MDS or another antecedent hematologic disease (AHD).\n      * AML after previous cytotoxic therapy or radiation (secondary AML).\n     \n     \n 2.  18 years of age (In Japan, 20 years of age).\n 3.  Adequate Organ Function as defined by the following: * Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) 3 x upper limit of normal (ULN), excluding subjects with liver function abnormalities due to underlying malignancy.\n      * Total serum bilirubin 2 x ULN (except subjects with documented Gilbert's syndrome).\n      * Estimated creatinine clearance 30 mL/min as calculated using the standard method for the institution.\n     \n     \n 4.  QTc interval 470 msec using the Fridericia correction (QTcF).\n 5.  All anti cancer treatments (unless specified) should be discontinued 2 weeks from study entry, for example: targeted chemotherapy, radiotherapy, investigational agents, hormones, anagrelide or cytokines. * For control of rapidly progressing leukemia, all trans retinoic acid (ATRA), hydroxyurea, and/or leukopheresis may be used before and for up to 1 week after the first dose of glasdegib.\n     \n     \n 6.  Serum or urine pregnancy test (for female subjects of childbearing potential) with a minimum sensitivity of 25 IU/L or equivalent units of human chorionic gonadotropin (hCG) negative at screening.\n 7.  Male and female subjects of childbearing potential and at risk for pregnancy must agree to use at least one highly effective method of contraception throughout the study and for 180 days after the last dose of azacitidine, cytarabine, or daunorubicin; and the last dose of glasdegib or placebo, whichever occurs later.\n 8.  Female subjects of non childbearing potential must meet at least 1 of the following criteria: 1. Have undergone a documented hysterectomy and/or bilateral oophorectomy;\n      2. Have medically confirmed ovarian failure; or\n      3. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; status may be confirmed by having a serum follicle stimulating hormone (FSH) level confirming the postmenopausal state.\n     \n     All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential.\n     \n     \n 9.  Consent to a saliva sample collection for a germline comparator, unless prohibited by local regulations or ethics committee (EC) decision.\n 10. Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.\n 11. Subjects who are willing and able to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures (including bone marrow [BM] assessments).\n\n","\n\nSubjects with any of the following characteristics/conditions will not be included in the study:\n\n 1.  Acute Promyelocytic Leukemia (APL) and APLwith PML RARA, subjects (WHO 2016 classification).\n 2.  AML with BCR ABL1 or t(9;22)(q34;q11.2) as a sole abnormality. * Complex genetics may include t(9;22) cytogenetic translocation.\n     \n     \n 3.  Subjects with known active CNS leukemia.\n 4.  Participation in other clinical studies involving other investigational drug(s) (Phases 1 4) within 4 weeks prior study entry and/or during study participation.\n 5.  Subjects known to be refractory to platelet or packed red cell transfusions per Institutional Guidelines, or a patient who refuses blood product support.\n 6.  Subjects with another active malignancy on treatment with the exception of basal cell carcinoma, non melanoma skin cancer, cervical carcinoma in situ. Other prior or concurrent malignancies will be considered on a case by case basis.\n 7.  Any one of the following ongoing or in the previous 6 months: myocardial infarction, congenital long QT syndrome, Torsades de pointes, symptomatic arrhythmias (including sustained ventricular tachyarrhythmia), right or left bundle branch block and bifascicular block, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (CHF New York Heart Association class III or IV), cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism; as well as bradycardia defined as <50 bpms.\n 8.  Subjects with an active, life threatening or clinically significant uncontrolled systemic infection not related to AML.\n 9.  Subjects with left ventricular ejection fraction (LVEF) <50% are excluded from the Intensive Chemotherapy Study only.\n 10. Cumulative anthracycline dose equivalent of 550 mg/m2 of daunorubicin for the Intensive Chemotherapy Study only.\n 11. Known malabsorption syndrome or other condition that may significantly impair absorption of study medication in the investigator's judgment (eg, gastrectomy, lap band, Crohn's disease) and inability or unwillingness to swallow tablets or capsules.\n 12. Current use or anticipated requirement for drugs that are known strong CYP3A4/5 inducers.\n 13. Concurrent administration of herbal preparations.\n 14. Major surgery or radiation within 4 weeks of starting study treatment.\n 15. Documented or suspected hypersensitivity to any one of the following: * For subjects assigned to intensive chemotherapy, documented or suspected hypersensitivity to cytarabine (not including drug fever or exanthema, including known cerebellar side effects) or daunorubicin.\n      * For subjects assigned to non intensive chemotherapy, documented or suspected hypersensitivity to azacitidine or mannitol.\n     \n     \n 16. Known active drug or alcohol abuse.\n 17. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.\n 18. Pregnant females or breastfeeding female subjects.\n 19. Known recent or active suicidal ideation or behavior.\n 20. Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.","FSH",null,"Protein","Ovary","Actual","2018-01-31","Actual","Anticipated","2025-07-22","Anticipated","2019-07-01","2017-12-21","2018-01-23","2019-07-26","Yes","glasdegib;\nuntreated;\nHedgehog Inhibitor","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"All",null,"No","Yes\nPfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",null,"URL: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1371019&StudyName=A+Randomized+%281%3A1%29%2C+Double+Blind%2C+Multi+Center%2C+Placebo+Controlled+Study+Evaluating+Intensive+Chemotherapy+With+Or+Without+Glasdegib+%28pf+04449913%29+Or+Azacitidine+%28aza%29+With+Or+Without+Glasdegib+In+Patients+With+Previously+Untreated+Acute+Myeloid+Leukemia [https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1371019&StudyName=A+Randomized+%281%3A1%29%2C+Double+Blind%2C+Multi+Center%2C+Placebo+Controlled+Study+Evaluating+Intensive+Chemotherapy+With+Or+Without+Glasdegib+%28pf+04449913%29+Or+Azacitidine+%28aza%29+With+Or+Without+Glasdegib+In+Patients+With+Previously+Untreated+Acute+Myeloid+Leukemia] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To obtain contact information for a study center near you, click here.",null,"Yes","No",{"$nulls":17},"2017-002822-19|BRIGHT|BRIGHT AML1019","EudraCT Number|Alias Study Number","Overall survival","5 years after last subject randomized",null,"Fatigue score measured by the MD Anderson Symptom Inventory (MDASI)-AML/MDS questionnaire|Rate of Complete Remission (CR) (including CR with minimal residual disease (MRD)-negative as assessed by multiparametric flow cytometry)|Duration of response (defined as CR [includes CR-MRD negative]/CRi or CR/CRh as appropriate)|Time to response (CR[includes CR-MRD negative)]/CR with partial hematologic rcovery (CRh) as appropriate)|Event-free Survival|Patient Reported Outcomes (PROs) as measured by the M.D. Anderson Symptom Inventory AML/MDS Module (MDASI-AML/MDS)|Adverse events as graded by NCI CTCAE v4.03|Laboratory abnormalities as graded by NCI CTCAE v4.03|For the intensive study, the plasma trough concentration (Ctrough) will be analyzed|QTc interval|PROs as measured by Patient Global Impression of Change (PGIC)|Patient Reported Outcomes (PROs) as measured by EuroQoL 5 Dimension questionnaire 5-Level version (EQ-5D-5L)|Patient Reported Outcomes (PROs) as measured by Patient Global Impression of Symptoms (PGIS)|Complete Remission with incomplete hematologic recovery (CRi)|Rate of morphological leukemia-free state (MLFS)|Rate of Partial Remission (PR)|Rate of Complete Remission with partial hematological recovery (CRh) for the Non-intensive study only only|Minimum Observed Plasma Trough Concentratrion of glasdegib in the Intensive Study|Minimum Observed Plasma Trough Concentration of glasdegib in the Non-intensive study","Scale is from 0-10 where 0 is not present and 10 is as bad as you can image.|Response as defined by the 2017 European LeukemiaNet (ELN) recommendations.|5 years after last subject randomized, consent withdrawal, or death|Measurement Scale from 0-10.|PK samples taken on Induction(s) Day 1 (1 and 4 hours post induction); Induction(s) Day 10 (pre-dose, 1 and 4 hours post dose); Day 1 of each Consolidation cycle (pre-dose, 1 and 4 hours post dose)|One question asking for description of leukemia symptoms.|Series of questions that ask for information that best describes health.|One question asking for information regarding leukemia symptoms.|Its the minimum trough concentration in plasma of glasdegib following multiple daily dosing to steady state.|It is the minimum trough concentration in plasma of glasdegib following multiple daily dosing to steady state.","5 years after last subject randomized, consent withdrawal, or death|2 years after last dose of study therapy|5 years after last patient randomized, withdrawal, or death|5 years after last subject randomized, withdrawal, or death|Day 10 of Induction Cycle and Day 1 of each Consolidation Cycle|Cycle 1 Day 15 and Cycles 2 and 3 on Day 1","ClinicalTrials.gov_Inquiries@pfizer.com","Pfizer CT.gov Call Center","1-800-718-1021","Adelaide, South|Darlinghurst, New South Wales, Australia, 2010 St George HospitalKogarah, New South Wales, Australia, 2217|Wels, Upper|Salzburg, Austria, 5020 Uniklinikum Salzburg, Landeskrankenhaus SalzburgSalzburg, Austria, 5020 Klinikum Wels-Grieskirchen GmbhWels, Austria, 4600 Sozialmedizinisches Zentrum Sud.Wien, Austria, 1100 Krankenhaus Hietzing Mit Neurologischem Zentrum RosenhugelWien, Austria, 1130|Brugge, Belgium, B-8000 Az Sint-Jan Brugge-Oostende AvBrugge, Belgium, B-8000 Universitaire Ziekenhuizen Brussel (Uz Brussel)Brussels, Belgium, B-1090 Universitaire Ziekenhuizen BrusselBrussels, Belgium, B-1090 Universitaire Ziekenhuizen LeuvenLeuven, Belgium, B-3000|Winnipeg, Manitoba, Canada, R3A 1R9 Cancercare ManitobaWinnipeg, Manitoba, Canada, R3E 0V9|Toronto, Ontario, Canada, M4N 3M5 Princess Margaret Cancer CentreToronto, Ontario, Canada, M5G 2M9|Montreal, Quebec, Canada, H1T 2M4|Fuzhou, Fujian, China, 350001|Guangzhou, Guangdong, China, 510317|Zhengzhou, Henan, China, 450008|Chengdu, Sichuan, China, 610041|Wuhan, Hubei, China, 430030|Nanjing, Jiangsu, China, 210029|Qingdao, Shandong, China, 266071|Shanghai, Shanghai, China, 200080|Tianjin, Tianjin, China, 300020|Hangzhou, Zhejiang, China, 310003|Brno, Czechia, 100 34 Nemocnicni LekarnaBrno, Czechia, 625 00 Ustavni LekarnaOstrava - Poruba, Czechia, 708 52 Klinika HematoonkologieOstrava-Poruba, Czechia, 708 52 InternÃ­ HematologickÃ¡ Klinika, Fakultni Nemocnice KrÃ¡lovskÃ© VinohradyPraha 10, Czechia, 100 34 Ãšstavni LÃ©kÃ¡rnaPraha 10, Czechia, 100 34|Creteil, France, 94010 Chu Henri MondorCrÃ©teil, France, 94010 Chu De NantesNantes Cedex 1, France, 44093 Chu De Nantes Hotel DieuNantes Cedex, France, 44093 Hopital Saint LouisParis, France, 75010 Centre Hospitalier Lyon Sud - Service D'HematologiePierre Benite Cedex, France, 69495 Centre Hospitalier Lyon Sud -Unite De Pharmacie Clinique OncologiquePierre Benite Cedex, France, 69495 Institut Gustave RoussyVillejuif Cedex, France, 94805|Hannover, Germany, 30625 UniversitÃ¤tsklinikum KÃ¶lnKoeln, Germany, 50937|Koeln, North Rhine Westphalia, Germany, 50937|Debrecen, Hungary, 4032 Debreceni Egyetem Klinikai Kozpont Belgyogyaszati KlinikaDebrecen, Hungary, 4032 Petz AladÃ¡r Megyei OktatÃ³ KÃ³rhÃ¡z, GyÃ³gyszerÃ©szeti OsztÃ¡lyGyÅ‘r, Hungary, 9024 Petz AladÃ¡r Megyei OktatÃ³ KÃ³rhÃ¡z, Ii. BelgyÃ³gyÃ¡szat- HematolÃ³giai OsztÃ¡lyGyÅ‘r, Hungary, 9024 Somogy Megyei Kaposi Mor Oktato KorhazKaposvar, Hungary, 7400 Szabolcs-Szatmar Bereg Megyei Korhazak Es Egyetemi Oktatokorhaz, Josa Andras Korhaz, HematologiaNyiregyhaza, Hungary, 4400 Szabolcs-Szatmar Bereg Megyei Korhazak Es Egyetemi Oktatokorhaz, Josa Andras Korhaz,Nyiregyhaza, Hungary, 4400|Boston, Massachusetts, United States, 02215|Haifa, Israel, 3109601 Shaare Zedek Medical CanterJerusalem, Israel, 9103102 Shaare Zedek Medical CenterJerusalem, Israel, 9103102 Hadassah Medical Center (Ein Kerem)Jerusalem, Israel, 91120 Hemato-Oncology Ambulatory ServicePetah Tikva, Israel, 4941492 Hematology Division - Oncology PharmacyPetah Tikva, Israel, 4941492 Rabin Medical Center, Beilinson HospitalPetah Tikva, Israel, 4941492|Torette Di Ancona, An, Italy, 60126|Torrette Di Ancona, Ancona, Italy, 60126|Bologna, Italy, 40138|Cona, Ferrara, Fe, Italy, 44124 Farmacia OspedalieraFerrara, Fe, Italy, 44121|Pesaro, Pu, Italy, 61122|Siena, Si, Italy, 53100|Nagoya, Aichi, Japan, 466-8650|Akita, Japan, 010-8543 Kyushu University HospitalFukuoka, Japan, 812-8582 National Hospital Organization Kumamoto Medical Center[Active, Not Recruiting]Kumamoto, Japan, 860-0008 Nagasaki University HospitalNagasaki, Japan, 852-8501 Tokyo Medical University HospitalTokyo, Japan, 160-0023 Korea, Republic Of, Jeollabuk-Do Chonbuk National University HospitalJeonju-Si, Jeollabuk-Do, Korea, Republic Of, 54907 Korea, Republic Of, Jeollanam-Do Chonnam National University Hwasun HospitalHwasun-Gun, Jeollanam-Do, Korea, Republic Of, 58128 Korea, Republic Of Department Of Pharmacy, Inje University Busan Paik HospitalBusan, Korea, Republic Of, 47392 Inje University Busan Paik HospitalBusan, Korea, Republic Of, 47392 Clinical Trial Pharmacy, Keimyung University Dongsan HospitalDaegu, Korea, Republic Of, 42601 Keimyung University Dongsan HospitalDaegu, Korea, Republic Of, 42601 Gachon University Gil Medical CenterIncheon, Korea, Republic Of, 21565 Seoul National University HospitalSeoul, Korea, Republic Of, 03080 Severance Hospital, Yonsei University Health SystemSeoul, Korea, Republic Of, 03722 Department Of Pharmacy, Samsung Medical CenterSeoul, Korea, Republic Of, 06351 Samsung Medical CenterSeoul, Korea, Republic Of, 06351 The Catholic University Of Korea Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591 The Catholic University Of Korea, Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591|Yoshida-Gun, Fukui, Japan, 910-1193|Maebashi, Gunma, Japan, 371-8511|Kobe-Shi, Hyogo, Japan, 650-0017|Yokohama, Kanagawa, Japan, 232-0024|Sendai, Miyagi, Japan, 980-8574|Osaka-City, Osaka, Japan, 545-8586 Kindai University HospitalOsaka-Sayama, Osaka, Japan, 589-8511|Sunto-Gun, Shizuoka, Japan, 411-8777|Tachikawa, Tokyo, Japan, 190-0014|MÃ©xico, Mexico, 06726|MÃ©xico, MÃ©x, Mexico, 14080|Gdansk, Poland, 80-214 Wwcoit Im. M. Kopernika W LodziLodz, Poland, 93-513|Cluj-Napoca, Cluj, Romania, 400124|Craiova, Dolj, Romania, 200136|Bucuresti, Romania, 010825 Spitalul Clinic Coltea, Clinica De HematologieBucuresti, Romania, 030171 Russian Federation Sbhi Cch No. 40 Hd MoscowMoscow, Russian Federation, 129301 State Budgetary Healthcare Institution Of MoscowMoscow, Russian Federation, 129301 Sbhi Nnr Nn Rch N. A. N.A. SemashkoNizhniy Novgorod, Russian Federation, 603126 State Budgetary Institution Of Ryazan Region 'Regional Clinical Hospital' (Sbi Rr Rch)Ryazan, Russian Federation, 390039 Fsbi Russrhti Fmba Of|Barcelona, Spain, 08003 Hospital De La Santa Creu I Sant PauBarcelona, Spain, 08025 Hospital Universitario Arnau De VilanovaLleida, Spain, 25198 Hospital General Universitario Gregorio MaranonMadrid, Spain, 28007 Hospital Universitario Ramon Y CajalMadrid, Spain, 28034 Hospital Universitario Virgen Del RocioSevilla, Spain, 41013 Hospital Universitari I Politecnic La FeValencia, Spain, 46026|Goteborg, Sweden, 413 45 Apl, Apl Sahlgrenska, Kliniska ProvningarGoteborg, Sweden, 413 46 Apoex VnOrebro, Sweden, 701 85 Universitetssjukhuset OrebroOrebro, Sweden, 701 85 Karolinska Universitetssjukhuset HuddingeStockholm, Sweden, 141 86 Taiwan National Cheng Kung University HospitalTainan, Taiwan, 704 National Taiwan University HospitalTaipei, Taiwan, 100 Department Of Clinical Trial Pharmacy, Taipei Veterans General HospitalTaipei, Taiwan, 11217 Taipei Veterans General HospitalTaipei, Taiwan, 11217 Division Of Pharmacy, Koo Foundation Sun Yat-Sen Cancer CenterTaipei, Taiwan, 112 Koo Foundation Sun Yat-Sen Cancer CenterTaipei, Taiwan, 112 Chang Gung Memorial Hospital-Linkou BranchTaoyuan City, Taiwan, 333 Chemotherapy Pharmacy, Chang Gung Memorial Hospital-Linkou BranchTaoyuan City, Taiwan, 333|Sutton, Surrey, United Kingdom, Sm2 5Pt|Birmingham, West Midlands, United Kingdom, B15 2Th University Hospitals Birmingham Nhs Foundation TrustBirmingham, West Midlands, United Kingdom, B30 3Hg|London, United Kingdom, Ec1A 7Be Imperial College Healthcare Nhs TrustLondon, United Kingdom, W12 0Hs|Los Angeles, California, United States, 90033 Lac+Usc Medical CenterLos Angeles, California, United States, 90033 Usc/Norris Comprehensive Cancer Center / Investigational Drug ServicesLos Angeles, California, United States, 90033 Usc/Norris Comprehensive Cancer CenterLos Angeles, California, United States, 90033 Rrmc - UclaLos Angeles, California, United States, 90095 Ucla Department Of MedicineLos Angeles, California, United States, 90095 Ucla Hematology/Oncology ClinicLos Angeles, California, United States, 90095 Ucla Ronald Reagan Medical CenterLos Angeles, California, United States, 90095 Keck Medicine Of Usc Norris Oncology/Hematology - Newport Beach Treatment CenterNewport Beach, California, United States, 92663 Usc Norris Oncology/Hematology - Newport BeachNewport Beach, California, United States, 92663 Uc Irvine Health - Chao Family Comprehensive Cancer CenterOrange, California, United States, 92868-3201 Uc Irvine Medical CenterOrange, California, United States, 92868-3201 Ucsf Helen Diller Family Comprehensive Cancer CenterSan Francisco, California, United States, 94143 University Of California, San Francisco Medical CenterSan Francisco, California, United States, 94143 University Of California, San FranciscoSan Francisco, California, United States, 94143|Boston, Massachusetts, United States, 02111 Tufts Medical CenterBoston, Massachusetts, United States, 02111 Massachusetts General HospitalBoston, Massachusetts, United States, 02114 Beth|Kansas City, Missouri, United States, 64132|Lake Success, New York, United States, 11042 North Shore University HospitalManhasset, New York, United States, 11030 Long Island Jewish Medical CenterNew Hyde Park, New York, United States, 11040 University Of Rochester Cancer Center PharmacyRochester, New York, United States, 14642 University Of Rochester Medical CenterRochester, New York, United States, 14642|Cleveland, Ohio, United States, 44106 University Hospitals Cleveland Medical CenterCleveland, Ohio, United States, 44106 Cleveland Clinic FoundationCleveland, Ohio, United States, 44195|Nashville, Tennessee, United States, 37203 The Sarah Cannon Research InstituteNashville, Tennessee, United States, 37203|Dallas, Texas, United States, 75246 Baylor University Medical CenterDallas, Texas, United States, 75246 The University Of Texas, Md Anderson Cancer CenterHouston, Texas, United States, 77030 Blood Cancer And Stem Cell Transplant ClinicSan Antonio, Texas, United States, 78229 Methodist Healthcare System Of San AntonioSan Antonio, Texas, United States, 78229 Methodist Hospital Investigational PharmacySan Antonio, Texas, United States, 78229|Seattle, Washington, United States, 98104 Swedish Investigational Drug Services PharmacySeattle, Washington, United States, 98104 Swedish Medical CenterSeattle, Washington, United States, 98122","California|Massachusetts|Missouri|New York|Ohio|Tennessee|Texas|Washington","Australia|Austria|Belgium|Canada|China|Czechia|France|Germany|Hungary|Israel|Italy|Japan|Mexico|Poland|Romania|Spain|Sweden|United Kingdom|United States","Australia, 5000 Royal Adelaide Hospital|New South Wales St Vincent's Hospital Sydney|Royal Adelaide Hospital - Clinical Trials Pharmacy|Klinikum Wels-Grieskirchen Gmbh|Landeskrankenhaus Salzburg, Universitatsklinik Fur Innere Medizin Iii Der Pmu|Az Sint-Jan Brugge - Oostende Av|Manitoba Health Sciences Centre|Ontario Sunnybrook Research Institute|Quebec Ciusss De L'Est-De-L'Ile-De- MontrÃ©al - HÃ´pital Maisonneuve-Rosemont|Fujian Fujian Medical University Union Hospital|Guangdong Guangdong Second Provincial General Hospital|Henan Henan Cancer Hostipal|Hospital, Sichuan University|Hubei Tongji Hospital, Tongji Medical College, Huazhong University Of Science & Technology/Cancer Center|Jiangsu Jiangsu Province Hospital|Shandong Affiliated Hospital Of Qingdao University/Hematology Department|Shanghai Shanghai General Hospital|Tianjin Institute Of Hematology And Blood Diseases Hospital, Chinese Academy Of Medical Sciences|Zhejiang The First Affiliated Hospital College Of Medicine, Zhejiang University|Interni Hematologicka A Onkologicka Klinika, Fakultni Nemocnice Brno|Chu Henri Mondor|Medizinische Hochschule Hannover|North Rhine Westphalia UniversitÃ¤tsklinikum KÃ¶ln|Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Klinika, Hematologia Tanszek|Deaconess Medical Center|Rambam Health Care Campus|An Sod Farmacia-Dipt Dei Servizi -Aou Ospedali Riuniti Umberto I, G.M. Lancisi, G. Salesi|Ancona Aou Ospedali Riuniti Umberto I, G.M. Lancisi, G. Salesi, Clinica Di Ematologia|Azienda Ospedaliero Universitaria Di Bologna Policlinico S.Orsola Malpighi|Fe A.O.U. Di Ferrara- Arcispedale Sant'Anna,|Pu Ao Ospedali Riuniti Marche Nord - Presidio Ospedaliero San Salvatore Di Pesaro -|Si Azienda Ospedaliera Universitaria Senese.|Aichi Japanese Red Cross Nagoya Daini Hospital|Akita University Hospital|Fukui University Of Fukui Hospital|Gunma Gunma University Hospital|Hyogo Kobe University Hospital|Kanagawa Yokohama City University Medical Center|Miyagi Tohoku University Hospital|Osaka Osaka City University Hospital|Shizuoka Shizuoka Cancer Center|Tokyo National Hospital Organization Disaster Medical Center|Hospital General De MÃ©xico Dr. Eduardo Liceaga|MÃ©x Instituto Nacional De CancerologÃ­a|Klinika Hematologii I Transplantologii Uniwersyteckie Centrum Kliniczne|Cluj Institutul Oncologic 'Prof. Dr. Ion Chiricuta'|Dolj Spitalul Clinic Municipal Filantropia Craiova, Sectia Clinica Hematologie|Spitalul Universitar De Urgenta Militar Central \"Dr. Carol Davila\" Bucuresti|Hospital Del Mar|Sektionen For Hematologi Och Koagulation|, Surrey The Royal Marsden Nhs Foundation Trust|, West Midlands University Hospitals Birmingham Nhs Foundation Trust|Barts Health Nhs Trust|Keck Hospital Of Usc|Tufts Medical Center Investigational Pharmacy|Midamerica Division, Inc., C/O Research Medical Center|Northwell Health/Monter Cancer Center|Taussig Cancer Center Investigational Pharmacy|Centennial Medical Center|Baylor Scott And White Research Institute|Swedish Cancer Institute",{"$nulls":3},"Pfizer CT.gov Call Center","2019-07-26","2020-05-25T16:39:36.743","2020-05-26T17:10:42.972","NCT03416179"]
["5ecbf4c911702c1b1b916bcd","NCT03416179","2019-08-06","Pfizer","PFE","Recruiting","A Study Evaluating Intensive Chemotherapy With or Without Glasdegib or Azacitidine With or Without Glasdegib In Patients With Previously Untreated Acute Myeloid Leukemia (BRIGHT AML1019)","Glasdegib|Cytarabine|Daunorubicin|Azacitidine","Hh Inhibitor|DNA Polymerase Inhibitor|Nucleic Acid Synthesis Inhibitor|TOP2 Inhibitor|DNA Mtase Inhibitor","Unknown",null,"Unknown",null,"Phase 3",4,720,"Anticipated","2018-04-20","2021-06-13","OS","Overall Survival",{"$nulls":3},"Glasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).\n\nGlasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).","Two separate registration trials conducted under one protocol number are proposed to adequately and independently evaluate the addition of glasdegib in intensive and non-intensive chemotherapy populations. Each study will have an experimental treatment arm and a placebo arm. Endpoints are the same for each study except where specifically indicated.\n\nAssignment to the Intensive Study or the Non-Intensive Study will be made by the Investigator based on the 2017 European LeukemiaNet (ELN) recommendations.\n\nStudy B1371019 is a randomized (1:1), double-blind, multi-center, placebo controlled study of chemotherapy in combination with glasdegib versus chemotherapy in combination with placebo in adult patients with previously untreated AML.\n\nGlasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).\n\nGlasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).","A RANDOMIZED (1:1), DOUBLE-BLIND, MULTI-CENTER, PLACEBO CONTROLLED STUDY EVALUATING INTENSIVE CHEMOTHERAPY WITH OR WITHOUT GLASDEGIB (PF-04449913) OR AZACITIDINE (AZA) WITH OR WITHOUT GLASDEGIB IN PATIENTS WITH PREVIOUSLY UNTREATED ACUTE MYELOID LEUKEMIA","B1371019","Leukemia, Myeloid, Acute","Acute Leukemia|Acute Myeloid Leukemia|Myeloid Leukemia|Leukemia","Oncology Hematological","Oncology","Experimental|Placebo Comparator","Arm A (Intensive Study)|Arm B (Intensive Study)|Arm A (Non-intensive study)|Arm B (Non-intensive study)","Glasdegib + '7+3' Induction(s)|Placebo + '7+3' Induction(s)|Glasdegib + azacitidine|Placebo + azacitidine","Drug|Procedure","glasdegib|daunorubicin + cytarabine|cytarabine|HSCT|Placebo|azacitidine","Daily Glasdegib (100 mg, PO), beginning on Day 1 and is to continue up to 2 years post randomization.\n\nFollowing consolidation therapy, glasdegib or placebo will be administered daily for up to 2 years after randomization or until they have minimal residual disease (MRD) negative disease, whichever comes first.\n\nDaily Glasdegib (100 mg, PO) or matching placebo will continue throughout Induction(s) and Consolidation therapies regardless of dose modifications/delays in the chemotherapy.|Consolidation with single agent cytarabine 3 g/m2 IV for adults <60 years and 1 g/m2 for adults 60 years over 3 BID on Days 1, 3, and 5, every 28 days for up to 4 cycles or alternative single agent cytarabine consolidation schedules may be used per local prescribing information.|If required, and done per standard of care post Induction(s).|Azacitidine (75 mg/m2, SC or IV) daily for 7 days, in 28 day cycles for as long as they do not meet the criteria for disease progression, unacceptable toxicity, consent withdrawal, or death.|Matching placebo (PO) is to be administered by mouth daily beginning on Day 1 of chemotherapy and will continue if subjects demonstrate reasonable evidence of clinical benefit and do not meet the criteria for progression regardless of any delays/modifications in the chemotherapy treatment. Subjects will continue placebo until disease progression, unacceptable toxicity, consent withdrawal, or death, whichever comes first.","PF-04449913","Arm A (Intensive Study)|Arm B (Intensive Study)|Arm A (Non-intensive study)|Arm B (Non-intensive study)","\n\nSubjects must meet all of the following inclusion criteria to be eligible for enrollment into the Intensive and Non Intensive study (unless where indicated):\n\n 1.  Subjects with untreated AML according to the World Health Organization (WHO) 2016 Classification2, including those with: * AML arising from MDS or another antecedent hematologic disease (AHD).\n      * AML after previous cytotoxic therapy or radiation (secondary AML).\n     \n     \n 2.  18 years of age (In Japan, 20 years of age).\n 3.  Adequate Organ Function as defined by the following: * Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) 3 x upper limit of normal (ULN), excluding subjects with liver function abnormalities due to underlying malignancy.\n      * Total serum bilirubin 2 x ULN (except subjects with documented Gilbert's syndrome).\n      * Estimated creatinine clearance 30 mL/min as calculated using the standard method for the institution.\n     \n     \n 4.  QTc interval 470 msec using the Fridericia correction (QTcF).\n 5.  All anti cancer treatments (unless specified) should be discontinued 2 weeks from study entry, for example: targeted chemotherapy, radiotherapy, investigational agents, hormones, anagrelide or cytokines. * For control of rapidly progressing leukemia, all trans retinoic acid (ATRA), hydroxyurea, and/or leukopheresis may be used before and for up to 1 week after the first dose of glasdegib.\n     \n     \n 6.  Serum or urine pregnancy test (for female subjects of childbearing potential) with a minimum sensitivity of 25 IU/L or equivalent units of human chorionic gonadotropin (hCG) negative at screening.\n 7.  Male and female subjects of childbearing potential and at risk for pregnancy must agree to use at least one highly effective method of contraception throughout the study and for 180 days after the last dose of azacitidine, cytarabine, or daunorubicin; and the last dose of glasdegib or placebo, whichever occurs later.\n 8.  Female subjects of non childbearing potential must meet at least 1 of the following criteria: 1. Have undergone a documented hysterectomy and/or bilateral oophorectomy;\n      2. Have medically confirmed ovarian failure; or\n      3. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; status may be confirmed by having a serum follicle stimulating hormone (FSH) level confirming the postmenopausal state.\n     \n     All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential.\n     \n     \n 9.  Consent to a saliva sample collection for a germline comparator, unless prohibited by local regulations or ethics committee (EC) decision.\n 10. Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.\n 11. Subjects who are willing and able to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures (including bone marrow [BM] assessments).\n\n","\n\nSubjects with any of the following characteristics/conditions will not be included in the study:\n\n 1.  Acute Promyelocytic Leukemia (APL) and APLwith PML RARA, subjects (WHO 2016 classification).\n 2.  AML with BCR ABL1 or t(9;22)(q34;q11.2) as a sole abnormality. * Complex genetics may include t(9;22) cytogenetic translocation.\n     \n     \n 3.  Subjects with known active CNS leukemia.\n 4.  Participation in other clinical studies involving other investigational drug(s) (Phases 1 4) within 4 weeks prior study entry and/or during study participation.\n 5.  Subjects known to be refractory to platelet or packed red cell transfusions per Institutional Guidelines, or a patient who refuses blood product support.\n 6.  Subjects with another active malignancy on treatment with the exception of basal cell carcinoma, non melanoma skin cancer, cervical carcinoma in situ. Other prior or concurrent malignancies will be considered on a case by case basis.\n 7.  Any one of the following ongoing or in the previous 6 months: myocardial infarction, congenital long QT syndrome, Torsades de pointes, symptomatic arrhythmias (including sustained ventricular tachyarrhythmia), right or left bundle branch block and bifascicular block, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (CHF New York Heart Association class III or IV), cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism; as well as bradycardia defined as <50 bpms.\n 8.  Subjects with an active, life threatening or clinically significant uncontrolled systemic infection not related to AML.\n 9.  Subjects with left ventricular ejection fraction (LVEF) <50% are excluded from the Intensive Chemotherapy Study only.\n 10. Cumulative anthracycline dose equivalent of 550 mg/m2 of daunorubicin for the Intensive Chemotherapy Study only.\n 11. Known malabsorption syndrome or other condition that may significantly impair absorption of study medication in the investigator's judgment (eg, gastrectomy, lap band, Crohn's disease) and inability or unwillingness to swallow tablets or capsules.\n 12. Current use or anticipated requirement for drugs that are known strong CYP3A4/5 inducers.\n 13. Concurrent administration of herbal preparations.\n 14. Major surgery or radiation within 4 weeks of starting study treatment.\n 15. Documented or suspected hypersensitivity to any one of the following: * For subjects assigned to intensive chemotherapy, documented or suspected hypersensitivity to cytarabine (not including drug fever or exanthema, including known cerebellar side effects) or daunorubicin.\n      * For subjects assigned to non intensive chemotherapy, documented or suspected hypersensitivity to azacitidine or mannitol.\n     \n     \n 16. Known active drug or alcohol abuse.\n 17. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.\n 18. Pregnant females or breastfeeding female subjects.\n 19. Known recent or active suicidal ideation or behavior.\n 20. Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.","FSH",null,"Protein","Ovary","Actual","2018-01-31","Actual","Anticipated","2025-07-22","Anticipated","2019-08-01","2017-12-21","2018-01-23","2019-08-03","Yes","glasdegib;\nuntreated;\nHedgehog Inhibitor","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"All",null,"No","Yes\nPfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",null,"URL: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1371019&StudyName=A+Randomized+%281%3A1%29%2C+Double+Blind%2C+Multi+Center%2C+Placebo+Controlled+Study+Evaluating+Intensive+Chemotherapy+With+Or+Without+Glasdegib+%28pf+04449913%29+Or+Azacitidine+%28aza%29+With+Or+Without+Glasdegib+In+Patients+With+Previously+Untreated+Acute+Myeloid+Leukemia [https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1371019&StudyName=A+Randomized+%281%3A1%29%2C+Double+Blind%2C+Multi+Center%2C+Placebo+Controlled+Study+Evaluating+Intensive+Chemotherapy+With+Or+Without+Glasdegib+%28pf+04449913%29+Or+Azacitidine+%28aza%29+With+Or+Without+Glasdegib+In+Patients+With+Previously+Untreated+Acute+Myeloid+Leukemia] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To obtain contact information for a study center near you, click here.",null,"Yes","No",{"$nulls":17},"2017-002822-19|BRIGHT|BRIGHT AML1019","EudraCT Number|Alias Study Number","Overall survival","5 years after last subject randomized",null,"Fatigue score measured by the MD Anderson Symptom Inventory (MDASI)-AML/MDS questionnaire|Rate of Complete Remission (CR) (including CR with minimal residual disease (MRD)-negative as assessed by multiparametric flow cytometry)|Duration of response (defined as CR [includes CR-MRD negative]/CRi or CR/CRh as appropriate)|Time to response (CR[includes CR-MRD negative)]/CR with partial hematologic rcovery (CRh) as appropriate)|Event-free Survival|Patient Reported Outcomes (PROs) as measured by the M.D. Anderson Symptom Inventory AML/MDS Module (MDASI-AML/MDS)|Adverse events as graded by NCI CTCAE v4.03|Laboratory abnormalities as graded by NCI CTCAE v4.03|For the intensive study, the plasma trough concentration (Ctrough) will be analyzed|QTc interval|PROs as measured by Patient Global Impression of Change (PGIC)|Patient Reported Outcomes (PROs) as measured by EuroQoL 5 Dimension questionnaire 5-Level version (EQ-5D-5L)|Patient Reported Outcomes (PROs) as measured by Patient Global Impression of Symptoms (PGIS)|Complete Remission with incomplete hematologic recovery (CRi)|Rate of morphological leukemia-free state (MLFS)|Rate of Partial Remission (PR)|Rate of Complete Remission with partial hematological recovery (CRh) for the Non-intensive study only only|Minimum Observed Plasma Trough Concentratrion of glasdegib in the Intensive Study|Minimum Observed Plasma Trough Concentration of glasdegib in the Non-intensive study","Scale is from 0-10 where 0 is not present and 10 is as bad as you can image.|Response as defined by the 2017 European LeukemiaNet (ELN) recommendations.|5 years after last subject randomized, consent withdrawal, or death|Measurement Scale from 0-10.|PK samples taken on Induction(s) Day 1 (1 and 4 hours post induction); Induction(s) Day 10 (pre-dose, 1 and 4 hours post dose); Day 1 of each Consolidation cycle (pre-dose, 1 and 4 hours post dose)|One question asking for description of leukemia symptoms.|Series of questions that ask for information that best describes health.|One question asking for information regarding leukemia symptoms.|Its the minimum trough concentration in plasma of glasdegib following multiple daily dosing to steady state.|It is the minimum trough concentration in plasma of glasdegib following multiple daily dosing to steady state.","5 years after last subject randomized, consent withdrawal, or death|2 years after last dose of study therapy|5 years after last patient randomized, withdrawal, or death|5 years after last subject randomized, withdrawal, or death|Day 10 of Induction Cycle and Day 1 of each Consolidation Cycle|Cycle 1 Day 15 and Cycles 2 and 3 on Day 1","ClinicalTrials.gov_Inquiries@pfizer.com","Pfizer CT.gov Call Center","1-800-718-1021","Adelaide, South|Darlinghurst, New South Wales, Australia, 2010 St George HospitalKogarah, New South Wales, Australia, 2217|Wels, Upper|Salzburg, Austria, 5020 Uniklinikum Salzburg, Landeskrankenhaus SalzburgSalzburg, Austria, 5020 Klinikum Wels-Grieskirchen GmbhWels, Austria, 4600 Sozialmedizinisches Zentrum Sud.Wien, Austria, 1100 Krankenhaus Hietzing Mit Neurologischem Zentrum RosenhugelWien, Austria, 1130|Brugge, Belgium, B-8000 Az Sint-Jan Brugge-Oostende AvBrugge, Belgium, B-8000 Universitaire Ziekenhuizen Brussel (Uz Brussel)Brussels, Belgium, B-1090 Universitaire Ziekenhuizen BrusselBrussels, Belgium, B-1090 Universitaire Ziekenhuizen LeuvenLeuven, Belgium, B-3000|Winnipeg, Manitoba, Canada, R3A 1R9 Cancercare ManitobaWinnipeg, Manitoba, Canada, R3E 0V9|Toronto, Ontario, Canada, M4N 3M5 Princess Margaret Cancer CentreToronto, Ontario, Canada, M5G 2M9|Montreal, Quebec, Canada, H1T 2M4|Fuzhou, Fujian, China, 350001|Guangzhou, Guangdong, China, 510317|Zhengzhou, Henan, China, 450008|Chengdu, Sichuan, China, 610041|Wuhan, Hubei, China, 430030|Nanjing, Jiangsu, China, 210029|Qingdao, Shandong, China, 266071|Shanghai, Shanghai, China, 200080|Tianjin, Tianjin, China, 300020|Hangzhou, Zhejiang, China, 310003|Brno, Czechia, 100 34 Nemocnicni LekarnaBrno, Czechia, 625 00 Ustavni LekarnaOstrava - Poruba, Czechia, 708 52 Klinika HematoonkologieOstrava-Poruba, Czechia, 708 52 InternÃ­ HematologickÃ¡ Klinika, Fakultni Nemocnice KrÃ¡lovskÃ© VinohradyPraha 10, Czechia, 100 34 Ãšstavni LÃ©kÃ¡rnaPraha 10, Czechia, 100 34|Creteil, France, 94010 Chu Henri MondorCrÃ©teil, France, 94010 Chu De NantesNantes Cedex 1, France, 44093 Chu De Nantes Hotel DieuNantes Cedex, France, 44093 Hopital Saint LouisParis, France, 75010 Centre Hospitalier Lyon Sud - Service D'HematologiePierre Benite Cedex, France, 69495 Centre Hospitalier Lyon Sud -Unite De Pharmacie Clinique OncologiquePierre Benite Cedex, France, 69495 Institut Gustave RoussyVillejuif Cedex, France, 94805|Hannover, Germany, 30625 UniversitÃ¤tsklinikum KÃ¶lnKoeln, Germany, 50937|Koeln, North Rhine Westphalia, Germany, 50937|Debrecen, Hungary, 4032 Debreceni Egyetem Klinikai Kozpont Belgyogyaszati KlinikaDebrecen, Hungary, 4032 Petz AladÃ¡r Megyei OktatÃ³ KÃ³rhÃ¡z, GyÃ³gyszerÃ©szeti OsztÃ¡lyGyÅ‘r, Hungary, 9024 Petz AladÃ¡r Megyei OktatÃ³ KÃ³rhÃ¡z, Ii. BelgyÃ³gyÃ¡szat- HematolÃ³giai OsztÃ¡lyGyÅ‘r, Hungary, 9024 Somogy Megyei Kaposi Mor Oktato KorhazKaposvar, Hungary, 7400 Szabolcs-Szatmar Bereg Megyei Korhazak Es Egyetemi Oktatokorhaz, Josa Andras Korhaz, HematologiaNyiregyhaza, Hungary, 4400 Szabolcs-Szatmar Bereg Megyei Korhazak Es Egyetemi Oktatokorhaz, Josa Andras Korhaz,Nyiregyhaza, Hungary, 4400|Boston, Massachusetts, United States, 02215|Haifa, Israel, 3109601 Shaare Zedek Medical CanterJerusalem, Israel, 9103102 Shaare Zedek Medical CenterJerusalem, Israel, 9103102 Hadassah Medical Center (Ein Kerem)Jerusalem, Israel, 91120 Hemato-Oncology Ambulatory ServicePetah Tikva, Israel, 4941492 Hematology Division - Oncology PharmacyPetah Tikva, Israel, 4941492 Rabin Medical Center, Beilinson HospitalPetah Tikva, Israel, 4941492 Tel-Aviv Sourasky Medical CenterTel Aviv, Israel, 6423906|Torette Di Ancona, An, Italy, 60126|Torrette Di Ancona, Ancona, Italy, 60126|Bologna, Italy, 40138|Cona, Ferrara, Fe, Italy, 44124 Farmacia OspedalieraFerrara, Fe, Italy, 44121|Pesaro, Pu, Italy, 61122|Roma, Rm, Italy, 00161|Siena, Si, Italy, 53100|Nagoya, Aichi, Japan, 466-8650|Akita, Japan, 010-8543 Kyushu University HospitalFukuoka, Japan, 812-8582 National Hospital Organization Kumamoto Medical Center[Active, Not Recruiting]Kumamoto, Japan, 860-0008 Nagasaki University HospitalNagasaki, Japan, 852-8501 Tokyo Medical University HospitalTokyo, Japan, 160-0023 Korea, Republic Of, Jeollabuk-Do Chonbuk National University HospitalJeonju-Si, Jeollabuk-Do, Korea, Republic Of, 54907 Korea, Republic Of, Jeollanam-Do Chonnam National University Hwasun HospitalHwasun-Gun, Jeollanam-Do, Korea, Republic Of, 58128 Korea, Republic Of Department Of Pharmacy, Inje University Busan Paik HospitalBusan, Korea, Republic Of, 47392 Inje University Busan Paik HospitalBusan, Korea, Republic Of, 47392 Clinical Trial Pharmacy, Keimyung University Dongsan HospitalDaegu, Korea, Republic Of, 42601 Keimyung University Dongsan HospitalDaegu, Korea, Republic Of, 42601 Gachon University Gil Medical CenterIncheon, Korea, Republic Of, 21565 Seoul National University HospitalSeoul, Korea, Republic Of, 03080 Severance Hospital, Yonsei University Health SystemSeoul, Korea, Republic Of, 03722 Department Of Pharmacy, Samsung Medical CenterSeoul, Korea, Republic Of, 06351 Samsung Medical CenterSeoul, Korea, Republic Of, 06351 The Catholic University Of Korea Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591 The Catholic University Of Korea, Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591|Yoshida-Gun, Fukui, Japan, 910-1193|Maebashi, Gunma, Japan, 371-8511|Kobe-Shi, Hyogo, Japan, 650-0017|Yokohama, Kanagawa, Japan, 232-0024|Sendai, Miyagi, Japan, 980-8574|Osaka-City, Osaka, Japan, 545-8586 Kindai University HospitalOsaka-Sayama, Osaka, Japan, 589-8511|Sunto-Gun, Shizuoka, Japan, 411-8777|Tachikawa, Tokyo, Japan, 190-0014|MÃ©xico, Mexico, 06726|MÃ©xico, MÃ©x, Mexico, 14080|Gdansk, Poland, 80-214 Wwcoit Im. M. Kopernika W LodziLodz, Poland, 93-513|Cluj-Napoca, Cluj, Romania, 400124|Craiova, Dolj, Romania, 200136|Bucuresti, Romania, 010825 Spitalul Clinic Coltea, Clinica De HematologieBucuresti, Romania, 030171 Russian Federation Sbhi Cch No. 40 Hd MoscowMoscow, Russian Federation, 129301 State Budgetary Healthcare Institution Of MoscowMoscow, Russian Federation, 129301 Sbhi Nnr Nn Rch N. A. N.A. SemashkoNizhniy Novgorod, Russian Federation, 603126 State Budgetary Institution Of Ryazan Region 'Regional Clinical Hospital' (Sbi Rr Rch)Ryazan, Russian Federation, 390039 Fsbi Russrhti Fmba Of|Barcelona, Spain, 08003 Hospital De La Santa Creu I Sant PauBarcelona, Spain, 08025 Hospital Universitario Arnau De VilanovaLleida, Spain, 25198 Hospital General Universitario Gregorio MaranonMadrid, Spain, 28007 Hospital Universitario Ramon Y CajalMadrid, Spain, 28034 Hospital Universitario Virgen Del RocioSevilla, Spain, 41013 Hospital Universitari I Politecnic La FeValencia, Spain, 46026|Goteborg, Sweden, 413 45 Apl, Apl Sahlgrenska, Kliniska ProvningarGoteborg, Sweden, 413 46 Apoex VnOrebro, Sweden, 701 85 Universitetssjukhuset OrebroOrebro, Sweden, 701 85 Karolinska Universitetssjukhuset HuddingeStockholm, Sweden, 141 86 Taiwan National Cheng Kung University HospitalTainan, Taiwan, 704 National Taiwan University HospitalTaipei, Taiwan, 100 Department Of Clinical Trial Pharmacy, Taipei Veterans General HospitalTaipei, Taiwan, 11217 Taipei Veterans General HospitalTaipei, Taiwan, 11217 Division Of Pharmacy, Koo Foundation Sun Yat-Sen Cancer CenterTaipei, Taiwan, 112 Koo Foundation Sun Yat-Sen Cancer CenterTaipei, Taiwan, 112 Chang Gung Memorial Hospital-Linkou BranchTaoyuan City, Taiwan, 333 Chemotherapy Pharmacy, Chang Gung Memorial Hospital-Linkou BranchTaoyuan City, Taiwan, 333|Sutton, Surrey, United Kingdom, Sm2 5Pt|Birmingham, West Midlands, United Kingdom, B15 2Th University Hospitals Birmingham Nhs Foundation TrustBirmingham, West Midlands, United Kingdom, B30 3Hg|London, United Kingdom, Ec1A 7Be Imperial College Healthcare Nhs TrustLondon, United Kingdom, W12 0Hs|Los Angeles, California, United States, 90033 Lac+Usc Medical CenterLos Angeles, California, United States, 90033 Usc/Norris Comprehensive Cancer Center / Investigational Drug ServicesLos Angeles, California, United States, 90033 Usc/Norris Comprehensive Cancer CenterLos Angeles, California, United States, 90033 Rrmc - UclaLos Angeles, California, United States, 90095 Ucla Department Of MedicineLos Angeles, California, United States, 90095 Ucla Hematology/Oncology ClinicLos Angeles, California, United States, 90095 Ucla Ronald Reagan Medical CenterLos Angeles, California, United States, 90095 Keck Medicine Of Usc Norris Oncology/Hematology - Newport Beach Treatment CenterNewport Beach, California, United States, 92663 Usc Norris Oncology/Hematology - Newport BeachNewport Beach, California, United States, 92663 Uc Irvine Health - Chao Family Comprehensive Cancer CenterOrange, California, United States, 92868-3201 Uc Irvine Medical CenterOrange, California, United States, 92868-3201 Ucsf Helen Diller Family Comprehensive Cancer CenterSan Francisco, California, United States, 94143 University Of California, San Francisco Medical CenterSan Francisco, California, United States, 94143 University Of California, San FranciscoSan Francisco, California, United States, 94143|Boston, Massachusetts, United States, 02111 Tufts Medical CenterBoston, Massachusetts, United States, 02111 Massachusetts General HospitalBoston, Massachusetts, United States, 02114 Beth|Kansas City, Missouri, United States, 64132|Lake Success, New York, United States, 11042 North Shore University HospitalManhasset, New York, United States, 11030 Long Island Jewish Medical CenterNew Hyde Park, New York, United States, 11040 University Of Rochester Cancer Center PharmacyRochester, New York, United States, 14642 University Of Rochester Medical CenterRochester, New York, United States, 14642|Cleveland, Ohio, United States, 44106 University Hospitals Cleveland Medical CenterCleveland, Ohio, United States, 44106 Cleveland Clinic FoundationCleveland, Ohio, United States, 44195|Portland, Oregon, United States, 97239 Oregon Health & Science University-Research Pharmacy ServicesPortland, Oregon, United States, 97239 Oregon Health & Science UniversityPortland, Oregon, United States, 97239|Nashville, Tennessee, United States, 37203 The Sarah Cannon Research InstituteNashville, Tennessee, United States, 37203|Dallas, Texas, United States, 75246 Baylor University Medical CenterDallas, Texas, United States, 75246 The University Of Texas, Md Anderson Cancer CenterHouston, Texas, United States, 77030 Blood Cancer And Stem Cell Transplant ClinicSan Antonio, Texas, United States, 78229 Methodist Healthcare System Of San AntonioSan Antonio, Texas, United States, 78229 Methodist Hospital Investigational PharmacySan Antonio, Texas, United States, 78229|Seattle, Washington, United States, 98104 Swedish Investigational Drug Services PharmacySeattle, Washington, United States, 98104 Swedish Medical CenterSeattle, Washington, United States, 98122","California|Massachusetts|Missouri|New York|Ohio|Oregon|Tennessee|Texas|Washington","Australia|Austria|Belgium|Canada|China|Czechia|France|Germany|Hungary|Israel|Italy|Japan|Mexico|Poland|Romania|Spain|Sweden|United Kingdom|United States","Australia, 5000 Royal Adelaide Hospital|New South Wales St Vincent's Hospital Sydney|Royal Adelaide Hospital - Clinical Trials Pharmacy|Klinikum Wels-Grieskirchen Gmbh|Landeskrankenhaus Salzburg, Universitatsklinik Fur Innere Medizin Iii Der Pmu|Az Sint-Jan Brugge - Oostende Av|Manitoba Health Sciences Centre|Ontario Sunnybrook Research Institute|Quebec Ciusss De L'Est-De-L'Ile-De- MontrÃ©al - HÃ´pital Maisonneuve-Rosemont|Fujian Fujian Medical University Union Hospital|Guangdong Guangdong Second Provincial General Hospital|Henan Henan Cancer Hostipal|Hospital, Sichuan University|Hubei Tongji Hospital, Tongji Medical College, Huazhong University Of Science & Technology/Cancer Center|Jiangsu Jiangsu Province Hospital|Shandong Affiliated Hospital Of Qingdao University/Hematology Department|Shanghai Shanghai General Hospital|Tianjin Institute Of Hematology And Blood Diseases Hospital, Chinese Academy Of Medical Sciences|Zhejiang The First Affiliated Hospital College Of Medicine, Zhejiang University|Interni Hematologicka A Onkologicka Klinika, Fakultni Nemocnice Brno|Chu Henri Mondor|Medizinische Hochschule Hannover|North Rhine Westphalia UniversitÃ¤tsklinikum KÃ¶ln|Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Klinika, Hematologia Tanszek|Deaconess Medical Center|Rambam Health Care Campus|An Sod Farmacia-Dipt Dei Servizi -Aou Ospedali Riuniti Umberto I, G.M. Lancisi, G. Salesi|Ancona Aou Ospedali Riuniti Umberto I, G.M. Lancisi, G. Salesi, Clinica Di Ematologia|Azienda Ospedaliero Universitaria Di Bologna Policlinico S.Orsola Malpighi|Fe A.O.U. Di Ferrara- Arcispedale Sant'Anna,|Pu Ao Ospedali Riuniti Marche Nord - Presidio Ospedaliero San Salvatore Di Pesaro -|Rm Azienda Ospedaliero Universitaria Policlinico Umberto I|Si Azienda Ospedaliera Universitaria Senese.|Aichi Japanese Red Cross Nagoya Daini Hospital|Akita University Hospital|Fukui University Of Fukui Hospital|Gunma Gunma University Hospital|Hyogo Kobe University Hospital|Kanagawa Yokohama City University Medical Center|Miyagi Tohoku University Hospital|Osaka Osaka City University Hospital|Shizuoka Shizuoka Cancer Center|Tokyo National Hospital Organization Disaster Medical Center|Hospital General De MÃ©xico Dr. Eduardo Liceaga|MÃ©x Instituto Nacional De CancerologÃ­a|Klinika Hematologii I Transplantologii Uniwersyteckie Centrum Kliniczne|Cluj Institutul Oncologic 'Prof. Dr. Ion Chiricuta'|Dolj Spitalul Clinic Municipal Filantropia Craiova, Sectia Clinica Hematologie|Spitalul Universitar De Urgenta Militar Central \"Dr. Carol Davila\" Bucuresti|Hospital Del Mar|Sektionen For Hematologi Och Koagulation|, Surrey The Royal Marsden Nhs Foundation Trust|, West Midlands University Hospitals Birmingham Nhs Foundation Trust|Barts Health Nhs Trust|Keck Hospital Of Usc|Tufts Medical Center Investigational Pharmacy|Midamerica Division, Inc., C/O Research Medical Center|Northwell Health/Monter Cancer Center|Taussig Cancer Center Investigational Pharmacy|Ohsu Center For Health And Healing|Centennial Medical Center|Baylor Scott And White Research Institute|Swedish Cancer Institute",{"$nulls":3},"Pfizer CT.gov Call Center","2019-08-03","2020-05-25T16:39:37.623","2020-05-26T17:10:42.972","NCT03416179"]
["5ecbf4c9feab101b155309ef","NCT03416179","2019-08-16","Pfizer","PFE","Recruiting","A Study Evaluating Intensive Chemotherapy With or Without Glasdegib or Azacitidine With or Without Glasdegib In Patients With Previously Untreated Acute Myeloid Leukemia (BRIGHT AML1019)","Glasdegib|Cytarabine|Daunorubicin|Azacitidine","Hh Inhibitor|DNA Polymerase Inhibitor|Nucleic Acid Synthesis Inhibitor|TOP2 Inhibitor|DNA Mtase Inhibitor","Unknown",null,"Unknown",null,"Phase 3",4,720,"Anticipated","2018-04-20","2021-06-13","OS","Overall Survival",{"$nulls":3},"Glasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).\n\nGlasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).","Two separate registration trials conducted under one protocol number are proposed to adequately and independently evaluate the addition of glasdegib in intensive and non-intensive chemotherapy populations. Each study will have an experimental treatment arm and a placebo arm. Endpoints are the same for each study except where specifically indicated.\n\nAssignment to the Intensive Study or the Non-Intensive Study will be made by the Investigator based on the 2017 European LeukemiaNet (ELN) recommendations.\n\nStudy B1371019 is a randomized (1:1), double-blind, multi-center, placebo controlled study of chemotherapy in combination with glasdegib versus chemotherapy in combination with placebo in adult patients with previously untreated AML.\n\nGlasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).\n\nGlasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).","A RANDOMIZED (1:1), DOUBLE-BLIND, MULTI-CENTER, PLACEBO CONTROLLED STUDY EVALUATING INTENSIVE CHEMOTHERAPY WITH OR WITHOUT GLASDEGIB (PF-04449913) OR AZACITIDINE (AZA) WITH OR WITHOUT GLASDEGIB IN PATIENTS WITH PREVIOUSLY UNTREATED ACUTE MYELOID LEUKEMIA","B1371019","Leukemia, Myeloid, Acute","Acute Leukemia|Acute Myeloid Leukemia|Myeloid Leukemia|Leukemia","Oncology Hematological","Oncology","Experimental|Placebo Comparator","Arm A (Intensive Study)|Arm B (Intensive Study)|Arm A (Non-intensive study)|Arm B (Non-intensive study)","Glasdegib + '7+3' Induction(s)|Placebo + '7+3' Induction(s)|Glasdegib + azacitidine|Placebo + azacitidine","Drug|Procedure","glasdegib|daunorubicin + cytarabine|cytarabine|HSCT|Placebo|azacitidine","Daily Glasdegib (100 mg, PO), beginning on Day 1 and is to continue up to 2 years post randomization.\n\nFollowing consolidation therapy, glasdegib or placebo will be administered daily for up to 2 years after randomization or until they have minimal residual disease (MRD) negative disease, whichever comes first.\n\nDaily Glasdegib (100 mg, PO) or matching placebo will continue throughout Induction(s) and Consolidation therapies regardless of dose modifications/delays in the chemotherapy.|Consolidation with single agent cytarabine 3 g/m2 IV for adults <60 years and 1 g/m2 for adults 60 years over 3 BID on Days 1, 3, and 5, every 28 days for up to 4 cycles or alternative single agent cytarabine consolidation schedules may be used per local prescribing information.|If required, and done per standard of care post Induction(s).|Azacitidine (75 mg/m2, SC or IV) daily for 7 days, in 28 day cycles for as long as they do not meet the criteria for disease progression, unacceptable toxicity, consent withdrawal, or death.|Matching placebo (PO) is to be administered by mouth daily beginning on Day 1 of chemotherapy and will continue if subjects demonstrate reasonable evidence of clinical benefit and do not meet the criteria for progression regardless of any delays/modifications in the chemotherapy treatment. Subjects will continue placebo until disease progression, unacceptable toxicity, consent withdrawal, or death, whichever comes first.","PF-04449913","Arm A (Intensive Study)|Arm B (Intensive Study)|Arm A (Non-intensive study)|Arm B (Non-intensive study)","\n\nSubjects must meet all of the following inclusion criteria to be eligible for enrollment into the Intensive and Non Intensive study (unless where indicated):\n\n 1.  Subjects with untreated AML according to the World Health Organization (WHO) 2016 Classification2, including those with: * AML arising from MDS or another antecedent hematologic disease (AHD).\n      * AML after previous cytotoxic therapy or radiation (secondary AML).\n     \n     \n 2.  18 years of age (In Japan, 20 years of age).\n 3.  Adequate Organ Function as defined by the following: * Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) 3 x upper limit of normal (ULN), excluding subjects with liver function abnormalities due to underlying malignancy.\n      * Total serum bilirubin 2 x ULN (except subjects with documented Gilbert's syndrome).\n      * Estimated creatinine clearance 30 mL/min as calculated using the standard method for the institution.\n     \n     \n 4.  QTc interval 470 msec using the Fridericia correction (QTcF).\n 5.  All anti cancer treatments (unless specified) should be discontinued 2 weeks from study entry, for example: targeted chemotherapy, radiotherapy, investigational agents, hormones, anagrelide or cytokines. * For control of rapidly progressing leukemia, all trans retinoic acid (ATRA), hydroxyurea, and/or leukopheresis may be used before and for up to 1 week after the first dose of glasdegib.\n     \n     \n 6.  Serum or urine pregnancy test (for female subjects of childbearing potential) with a minimum sensitivity of 25 IU/L or equivalent units of human chorionic gonadotropin (hCG) negative at screening.\n 7.  Male and female subjects of childbearing potential and at risk for pregnancy must agree to use at least one highly effective method of contraception throughout the study and for 180 days after the last dose of azacitidine, cytarabine, or daunorubicin; and the last dose of glasdegib or placebo, whichever occurs later.\n 8.  Female subjects of non childbearing potential must meet at least 1 of the following criteria: 1. Have undergone a documented hysterectomy and/or bilateral oophorectomy;\n      2. Have medically confirmed ovarian failure; or\n      3. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; status may be confirmed by having a serum follicle stimulating hormone (FSH) level confirming the postmenopausal state.\n     \n     All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential.\n     \n     \n 9.  Consent to a saliva sample collection for a germline comparator, unless prohibited by local regulations or ethics committee (EC) decision.\n 10. Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.\n 11. Subjects who are willing and able to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures (including bone marrow [BM] assessments).\n\n","\n\nSubjects with any of the following characteristics/conditions will not be included in the study:\n\n 1.  Acute Promyelocytic Leukemia (APL) and APLwith PML RARA, subjects (WHO 2016 classification).\n 2.  AML with BCR ABL1 or t(9;22)(q34;q11.2) as a sole abnormality. * Complex genetics may include t(9;22) cytogenetic translocation.\n     \n     \n 3.  Subjects with known active CNS leukemia.\n 4.  Participation in other clinical studies involving other investigational drug(s) (Phases 1 4) within 4 weeks prior study entry and/or during study participation.\n 5.  Subjects known to be refractory to platelet or packed red cell transfusions per Institutional Guidelines, or a patient who refuses blood product support.\n 6.  Subjects with another active malignancy on treatment with the exception of basal cell carcinoma, non melanoma skin cancer, cervical carcinoma in situ. Other prior or concurrent malignancies will be considered on a case by case basis.\n 7.  Any one of the following ongoing or in the previous 6 months: myocardial infarction, congenital long QT syndrome, Torsades de pointes, symptomatic arrhythmias (including sustained ventricular tachyarrhythmia), right or left bundle branch block and bifascicular block, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (CHF New York Heart Association class III or IV), cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism; as well as bradycardia defined as <50 bpms.\n 8.  Subjects with an active, life threatening or clinically significant uncontrolled systemic infection not related to AML.\n 9.  Subjects with left ventricular ejection fraction (LVEF) <50% are excluded from the Intensive Chemotherapy Study only.\n 10. Cumulative anthracycline dose equivalent of 550 mg/m2 of daunorubicin for the Intensive Chemotherapy Study only.\n 11. Known malabsorption syndrome or other condition that may significantly impair absorption of study medication in the investigator's judgment (eg, gastrectomy, lap band, Crohn's disease) and inability or unwillingness to swallow tablets or capsules.\n 12. Current use or anticipated requirement for drugs that are known strong CYP3A4/5 inducers.\n 13. Concurrent administration of herbal preparations.\n 14. Major surgery or radiation within 4 weeks of starting study treatment.\n 15. Documented or suspected hypersensitivity to any one of the following: * For subjects assigned to intensive chemotherapy, documented or suspected hypersensitivity to cytarabine (not including drug fever or exanthema, including known cerebellar side effects) or daunorubicin.\n      * For subjects assigned to non intensive chemotherapy, documented or suspected hypersensitivity to azacitidine or mannitol.\n     \n     \n 16. Known active drug or alcohol abuse.\n 17. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.\n 18. Pregnant females or breastfeeding female subjects.\n 19. Known recent or active suicidal ideation or behavior.\n 20. Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.","FSH",null,"Protein","Ovary","Actual","2018-01-31","Actual","Anticipated","2025-07-22","Anticipated","2019-08-01","2017-12-21","2018-01-23","2019-08-15","Yes","glasdegib;\nuntreated;\nHedgehog Inhibitor","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"All",null,"No","Yes\nPfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",null,"URL: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1371019&StudyName=A+Randomized+%281%3A1%29%2C+Double+Blind%2C+Multi+Center%2C+Placebo+Controlled+Study+Evaluating+Intensive+Chemotherapy+With+Or+Without+Glasdegib+%28pf+04449913%29+Or+Azacitidine+%28aza%29+With+Or+Without+Glasdegib+In+Patients+With+Previously+Untreated+Acute+Myeloid+Leukemia [https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1371019&StudyName=A+Randomized+%281%3A1%29%2C+Double+Blind%2C+Multi+Center%2C+Placebo+Controlled+Study+Evaluating+Intensive+Chemotherapy+With+Or+Without+Glasdegib+%28pf+04449913%29+Or+Azacitidine+%28aza%29+With+Or+Without+Glasdegib+In+Patients+With+Previously+Untreated+Acute+Myeloid+Leukemia] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To obtain contact information for a study center near you, click here.",null,"Yes","No",{"$nulls":17},"2017-002822-19|BRIGHT|BRIGHT AML1019","EudraCT Number|Alias Study Number","Overall survival","5 years after last subject randomized",null,"Fatigue score measured by the MD Anderson Symptom Inventory (MDASI)-AML/MDS questionnaire|Rate of Complete Remission (CR) (including CR with minimal residual disease (MRD)-negative as assessed by multiparametric flow cytometry)|Duration of response (defined as CR [includes CR-MRD negative]/CRi or CR/CRh as appropriate)|Time to response (CR[includes CR-MRD negative)]/CR with partial hematologic rcovery (CRh) as appropriate)|Event-free Survival|Patient Reported Outcomes (PROs) as measured by the M.D. Anderson Symptom Inventory AML/MDS Module (MDASI-AML/MDS)|Adverse events as graded by NCI CTCAE v4.03|Laboratory abnormalities as graded by NCI CTCAE v4.03|For the intensive study, the plasma trough concentration (Ctrough) will be analyzed|QTc interval|PROs as measured by Patient Global Impression of Change (PGIC)|Patient Reported Outcomes (PROs) as measured by EuroQoL 5 Dimension questionnaire 5-Level version (EQ-5D-5L)|Patient Reported Outcomes (PROs) as measured by Patient Global Impression of Symptoms (PGIS)|Complete Remission with incomplete hematologic recovery (CRi)|Rate of morphological leukemia-free state (MLFS)|Rate of Partial Remission (PR)|Rate of Complete Remission with partial hematological recovery (CRh) for the Non-intensive study only only|Minimum Observed Plasma Trough Concentratrion of glasdegib in the Intensive Study|Minimum Observed Plasma Trough Concentration of glasdegib in the Non-intensive study","Scale is from 0-10 where 0 is not present and 10 is as bad as you can image.|Response as defined by the 2017 European LeukemiaNet (ELN) recommendations.|5 years after last subject randomized, consent withdrawal, or death|Measurement Scale from 0-10.|PK samples taken on Induction(s) Day 1 (1 and 4 hours post induction); Induction(s) Day 10 (pre-dose, 1 and 4 hours post dose); Day 1 of each Consolidation cycle (pre-dose, 1 and 4 hours post dose)|One question asking for description of leukemia symptoms.|Series of questions that ask for information that best describes health.|One question asking for information regarding leukemia symptoms.|Its the minimum trough concentration in plasma of glasdegib following multiple daily dosing to steady state.|It is the minimum trough concentration in plasma of glasdegib following multiple daily dosing to steady state.","5 years after last subject randomized, consent withdrawal, or death|2 years after last dose of study therapy|5 years after last patient randomized, withdrawal, or death|5 years after last subject randomized, withdrawal, or death|Day 10 of Induction Cycle and Day 1 of each Consolidation Cycle|Cycle 1 Day 15 and Cycles 2 and 3 on Day 1","ClinicalTrials.gov_Inquiries@pfizer.com","Pfizer CT.gov Call Center","1-800-718-1021","Adelaide, South|Darlinghurst, New South Wales, Australia, 2010 St George HospitalKogarah, New South Wales, Australia, 2217|Wels, Upper|Salzburg, Austria, 5020 Uniklinikum Salzburg, Landeskrankenhaus SalzburgSalzburg, Austria, 5020 Klinikum Wels-Grieskirchen GmbhWels, Austria, 4600 Sozialmedizinisches Zentrum Sud.Wien, Austria, 1100 Krankenhaus Hietzing Mit Neurologischem Zentrum RosenhugelWien, Austria, 1130|Brugge, Belgium, B-8000 Az Sint-Jan Brugge-Oostende AvBrugge, Belgium, B-8000 Universitaire Ziekenhuizen Brussel (Uz Brussel)Brussels, Belgium, B-1090 Universitaire Ziekenhuizen BrusselBrussels, Belgium, B-1090 Universitaire Ziekenhuizen LeuvenLeuven, Belgium, B-3000|Winnipeg, Manitoba, Canada, R3A 1R9 Cancercare ManitobaWinnipeg, Manitoba, Canada, R3E 0V9|Toronto, Ontario, Canada, M4N 3M5 Princess Margaret Cancer CentreToronto, Ontario, Canada, M5G 2M9|Montreal, Quebec, Canada, H1T 2M4|Fuzhou, Fujian, China, 350001|Guangzhou, Guangdong, China, 510080 Guangdong Second Provincial General HospitalGuangzhou, Guangdong, China, 510317|Zhengzhou, Henan, China, 450008|Chengdu, Sichuan, China, 610041|Wuhan, Hubei, China, 430030|Nanjing, Jiangsu, China, 210029|Qingdao, Shandong, China, 266071|Shanghai, Shanghai, China, 200080|Tianjin, Tianjin, China, 300020|Hangzhou, Zhejiang, China, 310003|Brno, Czechia, 100 34 Nemocnicni LekarnaBrno, Czechia, 625 00 Ustavni LekarnaOstrava - Poruba, Czechia, 708 52 Klinika HematoonkologieOstrava-Poruba, Czechia, 708 52 InternÃ­ HematologickÃ¡ Klinika, Fakultni Nemocnice KrÃ¡lovskÃ© VinohradyPraha 10, Czechia, 100 34 Ãšstavni LÃ©kÃ¡rnaPraha 10, Czechia, 100 34|Creteil, France, 94010 Chu Henri MondorCrÃ©teil, France, 94010 Chu De NantesNantes Cedex 1, France, 44093 Chu De Nantes Hotel DieuNantes Cedex, France, 44093 Hopital Saint LouisParis, France, 75010 Centre Hospitalier Lyon Sud - Service D'HematologiePierre Benite Cedex, France, 69495 Centre Hospitalier Lyon Sud -Unite De Pharmacie Clinique OncologiquePierre Benite Cedex, France, 69495 Institut Gustave RoussyVillejuif Cedex, France, 94805|Hannover, Germany, 30625 UniversitÃ¤tsklinikum KÃ¶lnKoeln, Germany, 50937|Koeln, North Rhine Westphalia, Germany, 50937|Debrecen, Hungary, 4032 Debreceni Egyetem Klinikai Kozpont Belgyogyaszati KlinikaDebrecen, Hungary, 4032 Petz AladÃ¡r Megyei OktatÃ³ KÃ³rhÃ¡z, GyÃ³gyszerÃ©szeti OsztÃ¡lyGyÅ‘r, Hungary, 9024 Petz AladÃ¡r Megyei OktatÃ³ KÃ³rhÃ¡z, Ii. BelgyÃ³gyÃ¡szat- HematolÃ³giai OsztÃ¡lyGyÅ‘r, Hungary, 9024 Somogy Megyei Kaposi Mor Oktato KorhazKaposvar, Hungary, 7400 Szabolcs-Szatmar Bereg Megyei Korhazak Es Egyetemi Oktatokorhaz, Josa Andras Korhaz, HematologiaNyiregyhaza, Hungary, 4400 Szabolcs-Szatmar Bereg Megyei Korhazak Es Egyetemi Oktatokorhaz, Josa Andras Korhaz,Nyiregyhaza, Hungary, 4400|Boston, Massachusetts, United States, 02215|Haifa, Israel, 3109601 Shaare Zedek Medical CenterJerusalem, Israel, 9103102 Hadassah Medical Center (Ein Kerem)Jerusalem, Israel, 91120 Hemato-Oncology Ambulatory ServicePetah Tikva, Israel, 4941492 Hematology Division - Oncology PharmacyPetah Tikva, Israel, 4941492 Rabin Medical Center, Beilinson HospitalPetah Tikva, Israel, 4941492 Tel-Aviv Sourasky Medical CenterTel Aviv, Israel, 6423906|Torette Di Ancona, An, Italy, 60126|Torrette Di Ancona, Ancona, Italy, 60126|Bologna, Italy, 40138|Meldola, Fc, Italy, 47014|Cona, Ferrara, Fe, Italy, 44124 Farmacia OspedalieraFerrara, Fe, Italy, 44121|Pesaro, Pu, Italy, 61122|Roma, Rm, Italy, 00161|Siena, Si, Italy, 53100|Nagoya, Aichi, Japan, 466-8650|Akita, Japan, 010-8543 Kyushu University HospitalFukuoka, Japan, 812-8582 National Hospital Organization Kumamoto Medical Center[Active, Not Recruiting]Kumamoto, Japan, 860-0008 Nagasaki University HospitalNagasaki, Japan, 852-8501 Tokyo Medical University HospitalTokyo, Japan, 160-0023 Korea, Republic Of, Jeollabuk-Do Chonbuk National University HospitalJeonju-Si, Jeollabuk-Do, Korea, Republic Of, 54907 Korea, Republic Of, Jeollanam-Do Chonnam National University Hwasun HospitalHwasun-Gun, Jeollanam-Do, Korea, Republic Of, 58128 Korea, Republic Of Department Of Pharmacy, Inje University Busan Paik HospitalBusan, Korea, Republic Of, 47392 Inje University Busan Paik HospitalBusan, Korea, Republic Of, 47392 Clinical Trial Pharmacy, Keimyung University Dongsan HospitalDaegu, Korea, Republic Of, 42601 Keimyung University Dongsan HospitalDaegu, Korea, Republic Of, 42601 Gachon University Gil Medical CenterIncheon, Korea, Republic Of, 21565 Seoul National University HospitalSeoul, Korea, Republic Of, 03080 Severance Hospital, Yonsei University Health SystemSeoul, Korea, Republic Of, 03722 Department Of Pharmacy, Samsung Medical CenterSeoul, Korea, Republic Of, 06351 Samsung Medical CenterSeoul, Korea, Republic Of, 06351 The Catholic University Of Korea Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591 The Catholic University Of Korea, Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591|Yoshida-Gun, Fukui, Japan, 910-1193|Maebashi, Gunma, Japan, 371-8511|Kobe-Shi, Hyogo, Japan, 650-0017|Yokohama, Kanagawa, Japan, 232-0024|Sendai, Miyagi, Japan, 980-8574|Osaka-City, Osaka, Japan, 545-8586 Kindai University HospitalOsaka-Sayama, Osaka, Japan, 589-8511|Sunto-Gun, Shizuoka, Japan, 411-8777|Tachikawa, Tokyo, Japan, 190-0014|MÃ©xico, Mexico, 06726|MÃ©xico, MÃ©x, Mexico, 14080|Gdansk, Poland, 80-214 Wwcoit Im. M. Kopernika W LodziLodz, Poland, 93-513|Cluj-Napoca, Cluj, Romania, 400124|Craiova, Dolj, Romania, 200136|Bucuresti, Romania, 010825 Spitalul Clinic Coltea, Clinica De HematologieBucuresti, Romania, 030171 Russian Federation Sbhi Cch No. 40 Hd MoscowMoscow, Russian Federation, 129301 State Budgetary Healthcare Institution Of MoscowMoscow, Russian Federation, 129301 Sbhi Nnr Nn Rch N. A. N.A. SemashkoNizhniy Novgorod, Russian Federation, 603126 State Budgetary Institution Of Ryazan Region 'Regional Clinical Hospital' (Sbi Rr Rch)Ryazan, Russian Federation, 390039 Fsbi Russrhti Fmba Of|Barcelona, Spain, 08003 Hospital De La Santa Creu I Sant PauBarcelona, Spain, 08025 Hospital Universitario Arnau De VilanovaLleida, Spain, 25198 Hospital General Universitario Gregorio MaranonMadrid, Spain, 28007 Hospital Universitario Ramon Y CajalMadrid, Spain, 28034 Hospital Universitario Virgen Del RocioSevilla, Spain, 41013 Hospital Universitari I Politecnic La FeValencia, Spain, 46026|Goteborg, Sweden, 413 45 Apl, Apl Sahlgrenska, Kliniska ProvningarGoteborg, Sweden, 413 46 Apoex VnOrebro, Sweden, 701 85 Universitetssjukhuset OrebroOrebro, Sweden, 701 85 Karolinska Universitetssjukhuset HuddingeStockholm, Sweden, 141 86 Taiwan National Cheng Kung University HospitalTainan, Taiwan, 704 National Taiwan University HospitalTaipei, Taiwan, 100 Department Of Clinical Trial Pharmacy, Taipei Veterans General HospitalTaipei, Taiwan, 11217 Taipei Veterans General HospitalTaipei, Taiwan, 11217 Division Of Pharmacy, Koo Foundation Sun Yat-Sen Cancer CenterTaipei, Taiwan, 112 Koo Foundation Sun Yat-Sen Cancer CenterTaipei, Taiwan, 112 Chang Gung Memorial Hospital-Linkou BranchTaoyuan City, Taiwan, 333 Chemotherapy Pharmacy, Chang Gung Memorial Hospital-Linkou BranchTaoyuan City, Taiwan, 333|Sutton, Surrey, United Kingdom, Sm2 5Pt|Birmingham, West Midlands, United Kingdom, B15 2Th University Hospitals Birmingham Nhs Foundation TrustBirmingham, West Midlands, United Kingdom, B30 3Hg|London, United Kingdom, Ec1A 7Be Imperial College Healthcare Nhs TrustLondon, United Kingdom, W12 0Hs|Los Angeles, California, United States, 90033 Lac+Usc Medical CenterLos Angeles, California, United States, 90033 Usc/Norris Comprehensive Cancer Center / Investigational Drug ServicesLos Angeles, California, United States, 90033 Usc/Norris Comprehensive Cancer CenterLos Angeles, California, United States, 90033 Rrmc - UclaLos Angeles, California, United States, 90095 Ucla Department Of MedicineLos Angeles, California, United States, 90095 Ucla Hematology/Oncology ClinicLos Angeles, California, United States, 90095 Ucla Ronald Reagan Medical CenterLos Angeles, California, United States, 90095 Keck Medicine Of Usc Norris Oncology/Hematology - Newport Beach Treatment CenterNewport Beach, California, United States, 92663 Usc Norris Oncology/Hematology - Newport BeachNewport Beach, California, United States, 92663 Uc Irvine Health - Chao Family Comprehensive Cancer CenterOrange, California, United States, 92868-3201 Uc Irvine Medical CenterOrange, California, United States, 92868-3201 Ucsf Helen Diller Family Comprehensive Cancer CenterSan Francisco, California, United States, 94143 University Of California, San Francisco Medical CenterSan Francisco, California, United States, 94143 University Of California, San FranciscoSan Francisco, California, United States, 94143|Boston, Massachusetts, United States, 02111 Tufts Medical CenterBoston, Massachusetts, United States, 02111 Massachusetts General HospitalBoston, Massachusetts, United States, 02114 Beth|Kansas City, Missouri, United States, 64132|Lake Success, New York, United States, 11042 North Shore University HospitalManhasset, New York, United States, 11030 Long Island Jewish Medical CenterNew Hyde Park, New York, United States, 11040 University Of Rochester Cancer Center PharmacyRochester, New York, United States, 14642 University Of Rochester Medical CenterRochester, New York, United States, 14642|Cleveland, Ohio, United States, 44106 University Hospitals Cleveland Medical CenterCleveland, Ohio, United States, 44106 Cleveland Clinic FoundationCleveland, Ohio, United States, 44195|Portland, Oregon, United States, 97239 Oregon Health & Science University-Research Pharmacy ServicesPortland, Oregon, United States, 97239 Oregon Health & Science UniversityPortland, Oregon, United States, 97239|Nashville, Tennessee, United States, 37203 The Sarah Cannon Research InstituteNashville, Tennessee, United States, 37203|Dallas, Texas, United States, 75246 Baylor University Medical CenterDallas, Texas, United States, 75246 The University Of Texas, Md Anderson Cancer CenterHouston, Texas, United States, 77030 Blood Cancer And Stem Cell Transplant ClinicSan Antonio, Texas, United States, 78229 Methodist Healthcare System Of San AntonioSan Antonio, Texas, United States, 78229 Methodist Hospital Investigational PharmacySan Antonio, Texas, United States, 78229|Seattle, Washington, United States, 98104 Swedish Investigational Drug Services PharmacySeattle, Washington, United States, 98104 Swedish Medical CenterSeattle, Washington, United States, 98122","California|Massachusetts|Missouri|New York|Ohio|Oregon|Tennessee|Texas|Washington","Australia|Austria|Belgium|Canada|China|Czechia|France|Germany|Hungary|Israel|Italy|Japan|Mexico|Poland|Romania|Spain|Sweden|United Kingdom|United States","Australia, 5000 Royal Adelaide Hospital|New South Wales St Vincent's Hospital Sydney|Royal Adelaide Hospital - Clinical Trials Pharmacy|Klinikum Wels-Grieskirchen Gmbh|Landeskrankenhaus Salzburg, Universitatsklinik Fur Innere Medizin Iii Der Pmu|Az Sint-Jan Brugge - Oostende Av|Manitoba Health Sciences Centre|Ontario Sunnybrook Research Institute|Quebec Ciusss De L'Est-De-L'Ile-De- MontrÃ©al - HÃ´pital Maisonneuve-Rosemont|Fujian Fujian Medical University Union Hospital|Guangdong Guangdong Provincial People's Hospital|Henan Henan Cancer Hostipal|Hospital, Sichuan University|Hubei Tongji Hospital, Tongji Medical College, Huazhong University Of Science & Technology/Cancer Center|Jiangsu Jiangsu Province Hospital|Shandong Affiliated Hospital Of Qingdao University/Hematology Department|Shanghai Shanghai General Hospital|Tianjin Institute Of Hematology And Blood Diseases Hospital, Chinese Academy Of Medical Sciences|Zhejiang The First Affiliated Hospital College Of Medicine, Zhejiang University|Interni Hematologicka A Onkologicka Klinika, Fakultni Nemocnice Brno|Chu Henri Mondor|Medizinische Hochschule Hannover|North Rhine Westphalia UniversitÃ¤tsklinikum KÃ¶ln|Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Klinika, Hematologia Tanszek|Deaconess Medical Center|Rambam Health Care Campus|An Sod Farmacia-Dipt Dei Servizi -Aou Ospedali Riuniti Umberto I, G.M. Lancisi, G. Salesi|Ancona Aou Ospedali Riuniti Umberto I, G.M. Lancisi, G. Salesi, Clinica Di Ematologia|Azienda Ospedaliero Universitaria Di Bologna Policlinico S.Orsola Malpighi|Fc Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori|Fe A.O.U. Di Ferrara- Arcispedale Sant'Anna,|Pu Ao Ospedali Riuniti Marche Nord - Presidio Ospedaliero San Salvatore Di Pesaro -|Rm Azienda Ospedaliero Universitaria Policlinico Umberto I|Si Azienda Ospedaliera Universitaria Senese.|Aichi Japanese Red Cross Nagoya Daini Hospital|Akita University Hospital|Fukui University Of Fukui Hospital|Gunma Gunma University Hospital|Hyogo Kobe University Hospital|Kanagawa Yokohama City University Medical Center|Miyagi Tohoku University Hospital|Osaka Osaka City University Hospital|Shizuoka Shizuoka Cancer Center|Tokyo National Hospital Organization Disaster Medical Center|Hospital General De MÃ©xico Dr. Eduardo Liceaga|MÃ©x Instituto Nacional De CancerologÃ­a|Klinika Hematologii I Transplantologii Uniwersyteckie Centrum Kliniczne|Cluj Institutul Oncologic 'Prof. Dr. Ion Chiricuta'|Dolj Spitalul Clinic Municipal Filantropia Craiova, Sectia Clinica Hematologie|Spitalul Universitar De Urgenta Militar Central \"Dr. Carol Davila\" Bucuresti|Hospital Del Mar|Sektionen For Hematologi Och Koagulation|, Surrey The Royal Marsden Nhs Foundation Trust|, West Midlands University Hospitals Birmingham Nhs Foundation Trust|Barts Health Nhs Trust|Keck Hospital Of Usc|Tufts Medical Center Investigational Pharmacy|Midamerica Division, Inc., C/O Research Medical Center|Northwell Health/Monter Cancer Center|Taussig Cancer Center Investigational Pharmacy|Ohsu Center For Health And Healing|Centennial Medical Center|Baylor Scott And White Research Institute|Swedish Cancer Institute",{"$nulls":3},"Pfizer CT.gov Call Center","2019-08-15","2020-05-25T16:39:37.309","2020-05-26T17:10:42.972","NCT03416179"]
["5ecbf4c9feab101b155309f0","NCT03416179","2019-08-20","Pfizer","PFE","Recruiting","A Study Evaluating Intensive Chemotherapy With or Without Glasdegib or Azacitidine With or Without Glasdegib In Patients With Previously Untreated Acute Myeloid Leukemia (BRIGHT AML1019)","Glasdegib|Cytarabine|Daunorubicin|Azacitidine","Hh Inhibitor|DNA Polymerase Inhibitor|Nucleic Acid Synthesis Inhibitor|TOP2 Inhibitor|DNA Mtase Inhibitor","Unknown",null,"Unknown",null,"Phase 3",4,720,"Anticipated","2018-04-20","2021-06-13","OS","Overall Survival",{"$nulls":3},"Glasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).\n\nGlasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).","Two separate registration trials conducted under one protocol number are proposed to adequately and independently evaluate the addition of glasdegib in intensive and non-intensive chemotherapy populations. Each study will have an experimental treatment arm and a placebo arm. Endpoints are the same for each study except where specifically indicated.\n\nAssignment to the Intensive Study or the Non-Intensive Study will be made by the Investigator based on the 2017 European LeukemiaNet (ELN) recommendations.\n\nStudy B1371019 is a randomized (1:1), double-blind, multi-center, placebo controlled study of chemotherapy in combination with glasdegib versus chemotherapy in combination with placebo in adult patients with previously untreated AML.\n\nGlasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).\n\nGlasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).","A RANDOMIZED (1:1), DOUBLE-BLIND, MULTI-CENTER, PLACEBO CONTROLLED STUDY EVALUATING INTENSIVE CHEMOTHERAPY WITH OR WITHOUT GLASDEGIB (PF-04449913) OR AZACITIDINE (AZA) WITH OR WITHOUT GLASDEGIB IN PATIENTS WITH PREVIOUSLY UNTREATED ACUTE MYELOID LEUKEMIA","B1371019","Leukemia, Myeloid, Acute","Acute Leukemia|Acute Myeloid Leukemia|Myeloid Leukemia|Leukemia","Oncology Hematological","Oncology","Experimental|Placebo Comparator","Arm A (Intensive Study)|Arm B (Intensive Study)|Arm A (Non-intensive study)|Arm B (Non-intensive study)","Glasdegib + '7+3' Induction(s)|Placebo + '7+3' Induction(s)|Glasdegib + azacitidine|Placebo + azacitidine","Drug|Procedure","glasdegib|daunorubicin + cytarabine|cytarabine|HSCT|Placebo|azacitidine","Daily Glasdegib (100 mg, PO), beginning on Day 1 and is to continue up to 2 years post randomization.\n\nFollowing consolidation therapy, glasdegib or placebo will be administered daily for up to 2 years after randomization or until they have minimal residual disease (MRD) negative disease, whichever comes first.\n\nDaily Glasdegib (100 mg, PO) or matching placebo will continue throughout Induction(s) and Consolidation therapies regardless of dose modifications/delays in the chemotherapy.|Consolidation with single agent cytarabine 3 g/m2 IV for adults <60 years and 1 g/m2 for adults 60 years over 3 BID on Days 1, 3, and 5, every 28 days for up to 4 cycles or alternative single agent cytarabine consolidation schedules may be used per local prescribing information.|If required, and done per standard of care post Induction(s).|Azacitidine (75 mg/m2, SC or IV) daily for 7 days, in 28 day cycles for as long as they do not meet the criteria for disease progression, unacceptable toxicity, consent withdrawal, or death.|Matching placebo (PO) is to be administered by mouth daily beginning on Day 1 of chemotherapy and will continue if subjects demonstrate reasonable evidence of clinical benefit and do not meet the criteria for progression regardless of any delays/modifications in the chemotherapy treatment. Subjects will continue placebo until disease progression, unacceptable toxicity, consent withdrawal, or death, whichever comes first.","PF-04449913","Arm A (Intensive Study)|Arm B (Intensive Study)|Arm A (Non-intensive study)|Arm B (Non-intensive study)","\n\nSubjects must meet all of the following inclusion criteria to be eligible for enrollment into the Intensive and Non Intensive study (unless where indicated):\n\n 1.  Subjects with untreated AML according to the World Health Organization (WHO) 2016 Classification2, including those with: * AML arising from MDS or another antecedent hematologic disease (AHD).\n      * AML after previous cytotoxic therapy or radiation (secondary AML).\n     \n     \n 2.  18 years of age (In Japan, 20 years of age).\n 3.  Adequate Organ Function as defined by the following: * Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) 3 x upper limit of normal (ULN), excluding subjects with liver function abnormalities due to underlying malignancy.\n      * Total serum bilirubin 2 x ULN (except subjects with documented Gilbert's syndrome).\n      * Estimated creatinine clearance 30 mL/min as calculated using the standard method for the institution.\n     \n     \n 4.  QTc interval 470 msec using the Fridericia correction (QTcF).\n 5.  All anti cancer treatments (unless specified) should be discontinued 2 weeks from study entry, for example: targeted chemotherapy, radiotherapy, investigational agents, hormones, anagrelide or cytokines. * For control of rapidly progressing leukemia, all trans retinoic acid (ATRA), hydroxyurea, and/or leukopheresis may be used before and for up to 1 week after the first dose of glasdegib.\n     \n     \n 6.  Serum or urine pregnancy test (for female subjects of childbearing potential) with a minimum sensitivity of 25 IU/L or equivalent units of human chorionic gonadotropin (hCG) negative at screening.\n 7.  Male and female subjects of childbearing potential and at risk for pregnancy must agree to use at least one highly effective method of contraception throughout the study and for 180 days after the last dose of azacitidine, cytarabine, or daunorubicin; and the last dose of glasdegib or placebo, whichever occurs later.\n 8.  Female subjects of non childbearing potential must meet at least 1 of the following criteria: 1. Have undergone a documented hysterectomy and/or bilateral oophorectomy;\n      2. Have medically confirmed ovarian failure; or\n      3. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; status may be confirmed by having a serum follicle stimulating hormone (FSH) level confirming the postmenopausal state.\n     \n     All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential.\n     \n     \n 9.  Consent to a saliva sample collection for a germline comparator, unless prohibited by local regulations or ethics committee (EC) decision.\n 10. Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.\n 11. Subjects who are willing and able to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures (including bone marrow [BM] assessments).\n\n","\n\nSubjects with any of the following characteristics/conditions will not be included in the study:\n\n 1.  Acute Promyelocytic Leukemia (APL) and APLwith PML RARA, subjects (WHO 2016 classification).\n 2.  AML with BCR ABL1 or t(9;22)(q34;q11.2) as a sole abnormality. * Complex genetics may include t(9;22) cytogenetic translocation.\n     \n     \n 3.  Subjects with known active CNS leukemia.\n 4.  Participation in other clinical studies involving other investigational drug(s) (Phases 1 4) within 4 weeks prior study entry and/or during study participation.\n 5.  Subjects known to be refractory to platelet or packed red cell transfusions per Institutional Guidelines, or a patient who refuses blood product support.\n 6.  Subjects with another active malignancy on treatment with the exception of basal cell carcinoma, non melanoma skin cancer, cervical carcinoma in situ. Other prior or concurrent malignancies will be considered on a case by case basis.\n 7.  Any one of the following ongoing or in the previous 6 months: myocardial infarction, congenital long QT syndrome, Torsades de pointes, symptomatic arrhythmias (including sustained ventricular tachyarrhythmia), right or left bundle branch block and bifascicular block, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (CHF New York Heart Association class III or IV), cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism; as well as bradycardia defined as <50 bpms.\n 8.  Subjects with an active, life threatening or clinically significant uncontrolled systemic infection not related to AML.\n 9.  Subjects with left ventricular ejection fraction (LVEF) <50% are excluded from the Intensive Chemotherapy Study only.\n 10. Cumulative anthracycline dose equivalent of 550 mg/m2 of daunorubicin for the Intensive Chemotherapy Study only.\n 11. Known malabsorption syndrome or other condition that may significantly impair absorption of study medication in the investigator's judgment (eg, gastrectomy, lap band, Crohn's disease) and inability or unwillingness to swallow tablets or capsules.\n 12. Current use or anticipated requirement for drugs that are known strong CYP3A4/5 inducers.\n 13. Concurrent administration of herbal preparations.\n 14. Major surgery or radiation within 4 weeks of starting study treatment.\n 15. Documented or suspected hypersensitivity to any one of the following: * For subjects assigned to intensive chemotherapy, documented or suspected hypersensitivity to cytarabine (not including drug fever or exanthema, including known cerebellar side effects) or daunorubicin.\n      * For subjects assigned to non intensive chemotherapy, documented or suspected hypersensitivity to azacitidine or mannitol.\n     \n     \n 16. Known active drug or alcohol abuse.\n 17. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.\n 18. Pregnant females or breastfeeding female subjects.\n 19. Known recent or active suicidal ideation or behavior.\n 20. Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.","FSH",null,"Protein","Ovary","Actual","2018-01-31","Actual","Anticipated","2025-07-22","Anticipated","2019-08-01","2017-12-21","2018-01-23","2019-08-17","Yes","glasdegib;\nuntreated;\nHedgehog Inhibitor","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"All",null,"No","Yes\nPfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",null,"URL: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1371019&StudyName=A+Randomized+%281%3A1%29%2C+Double+Blind%2C+Multi+Center%2C+Placebo+Controlled+Study+Evaluating+Intensive+Chemotherapy+With+Or+Without+Glasdegib+%28pf+04449913%29+Or+Azacitidine+%28aza%29+With+Or+Without+Glasdegib+In+Patients+With+Previously+Untreated+Acute+Myeloid+Leukemia [https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1371019&StudyName=A+Randomized+%281%3A1%29%2C+Double+Blind%2C+Multi+Center%2C+Placebo+Controlled+Study+Evaluating+Intensive+Chemotherapy+With+Or+Without+Glasdegib+%28pf+04449913%29+Or+Azacitidine+%28aza%29+With+Or+Without+Glasdegib+In+Patients+With+Previously+Untreated+Acute+Myeloid+Leukemia] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To obtain contact information for a study center near you, click here.",null,"Yes","No",{"$nulls":17},"2017-002822-19|BRIGHT|BRIGHT AML1019","EudraCT Number|Alias Study Number","Overall survival","5 years after last subject randomized",null,"Fatigue score measured by the MD Anderson Symptom Inventory (MDASI)-AML/MDS questionnaire|Rate of Complete Remission (CR) (including CR with minimal residual disease (MRD)-negative as assessed by multiparametric flow cytometry)|Duration of response (defined as CR [includes CR-MRD negative]/CRi or CR/CRh as appropriate)|Time to response (CR[includes CR-MRD negative)]/CR with partial hematologic rcovery (CRh) as appropriate)|Event-free Survival|Patient Reported Outcomes (PROs) as measured by the M.D. Anderson Symptom Inventory AML/MDS Module (MDASI-AML/MDS)|Adverse events as graded by NCI CTCAE v4.03|Laboratory abnormalities as graded by NCI CTCAE v4.03|For the intensive study, the plasma trough concentration (Ctrough) will be analyzed|QTc interval|PROs as measured by Patient Global Impression of Change (PGIC)|Patient Reported Outcomes (PROs) as measured by EuroQoL 5 Dimension questionnaire 5-Level version (EQ-5D-5L)|Patient Reported Outcomes (PROs) as measured by Patient Global Impression of Symptoms (PGIS)|Complete Remission with incomplete hematologic recovery (CRi)|Rate of morphological leukemia-free state (MLFS)|Rate of Partial Remission (PR)|Rate of Complete Remission with partial hematological recovery (CRh) for the Non-intensive study only only|Minimum Observed Plasma Trough Concentratrion of glasdegib in the Intensive Study|Minimum Observed Plasma Trough Concentration of glasdegib in the Non-intensive study","Scale is from 0-10 where 0 is not present and 10 is as bad as you can image.|Response as defined by the 2017 European LeukemiaNet (ELN) recommendations.|5 years after last subject randomized, consent withdrawal, or death|Measurement Scale from 0-10.|PK samples taken on Induction(s) Day 1 (1 and 4 hours post induction); Induction(s) Day 10 (pre-dose, 1 and 4 hours post dose); Day 1 of each Consolidation cycle (pre-dose, 1 and 4 hours post dose)|One question asking for description of leukemia symptoms.|Series of questions that ask for information that best describes health.|One question asking for information regarding leukemia symptoms.|Its the minimum trough concentration in plasma of glasdegib following multiple daily dosing to steady state.|It is the minimum trough concentration in plasma of glasdegib following multiple daily dosing to steady state.","5 years after last subject randomized, consent withdrawal, or death|2 years after last dose of study therapy|5 years after last patient randomized, withdrawal, or death|5 years after last subject randomized, withdrawal, or death|Day 10 of Induction Cycle and Day 1 of each Consolidation Cycle|Cycle 1 Day 15 and Cycles 2 and 3 on Day 1","ClinicalTrials.gov_Inquiries@pfizer.com","Pfizer CT.gov Call Center","1-800-718-1021","Adelaide, South|Darlinghurst, New South Wales, Australia, 2010 St George HospitalKogarah, New South Wales, Australia, 2217|Wels, Upper|Salzburg, Austria, 5020 Uniklinikum Salzburg, Landeskrankenhaus SalzburgSalzburg, Austria, 5020 Klinikum Wels-Grieskirchen GmbhWels, Austria, 4600 Sozialmedizinisches Zentrum Sud.Wien, Austria, 1100 Krankenhaus Hietzing Mit Neurologischem Zentrum RosenhugelWien, Austria, 1130|Brugge, Belgium, B-8000 Az Sint-Jan Brugge-Oostende AvBrugge, Belgium, B-8000 Universitaire Ziekenhuizen Brussel (Uz Brussel)Brussels, Belgium, B-1090 Universitaire Ziekenhuizen BrusselBrussels, Belgium, B-1090 Universitaire Ziekenhuizen LeuvenLeuven, Belgium, B-3000|Winnipeg, Manitoba, Canada, R3A 1R9 Cancercare ManitobaWinnipeg, Manitoba, Canada, R3E 0V9|Toronto, Ontario, Canada, M4N 3M5 Princess Margaret Cancer CentreToronto, Ontario, Canada, M5G 2M9|Montreal, Quebec, Canada, H1T 2M4|Fuzhou, Fujian, China, 350001|Guangzhou, Guangdong, China, 510080 Guangdong Second Provincial General HospitalGuangzhou, Guangdong, China, 510317|Zhengzhou, Henan, China, 450008|Chengdu, Sichuan, China, 610041|Wuhan, Hubei, China, 430030|Nanjing, Jiangsu, China, 210029|Qingdao, Shandong, China, 266071|Shanghai, Shanghai, China, 200080|Tianjin, Tianjin, China, 300020|Hangzhou, Zhejiang, China, 310003|Brno, Czechia, 100 34 Nemocnicni LekarnaBrno, Czechia, 625 00 Ustavni LekarnaOstrava - Poruba, Czechia, 708 52 Klinika HematoonkologieOstrava-Poruba, Czechia, 708 52 InternÃ­ HematologickÃ¡ Klinika, Fakultni Nemocnice KrÃ¡lovskÃ© VinohradyPraha 10, Czechia, 100 34 Ãšstavni LÃ©kÃ¡rnaPraha 10, Czechia, 100 34|Creteil, France, 94010 Chu Henri MondorCrÃ©teil, France, 94010 Chu De NantesNantes Cedex 1, France, 44093 Chu De Nantes Hotel DieuNantes Cedex, France, 44093 Hopital Saint LouisParis, France, 75010 Centre Hospitalier Lyon Sud - Service D'HematologiePierre Benite Cedex, France, 69495 Centre Hospitalier Lyon Sud -Unite De Pharmacie Clinique OncologiquePierre Benite Cedex, France, 69495 Institut Gustave RoussyVillejuif Cedex, France, 94805|Hannover, Germany, 30625 UniversitÃ¤tsklinikum KÃ¶lnKoeln, Germany, 50937|Koeln, North Rhine Westphalia, Germany, 50937|Debrecen, Hungary, 4032 Debreceni Egyetem Klinikai Kozpont Belgyogyaszati KlinikaDebrecen, Hungary, 4032 Petz AladÃ¡r Megyei OktatÃ³ KÃ³rhÃ¡z, GyÃ³gyszerÃ©szeti OsztÃ¡lyGyÅ‘r, Hungary, 9024 Petz AladÃ¡r Megyei OktatÃ³ KÃ³rhÃ¡z, Ii. BelgyÃ³gyÃ¡szat- HematolÃ³giai OsztÃ¡lyGyÅ‘r, Hungary, 9024 Somogy Megyei Kaposi Mor Oktato KorhazKaposvar, Hungary, 7400 Szabolcs-Szatmar Bereg Megyei Korhazak Es Egyetemi Oktatokorhaz, Josa Andras Korhaz, HematologiaNyiregyhaza, Hungary, 4400 Szabolcs-Szatmar Bereg Megyei Korhazak Es Egyetemi Oktatokorhaz, Josa Andras Korhaz,Nyiregyhaza, Hungary, 4400|Boston, Massachusetts, United States, 02215|Haifa, Israel, 3109601 Shaare Zedek Medical CenterJerusalem, Israel, 9103102 Hadassah Medical Center (Ein Kerem)Jerusalem, Israel, 91120 Hemato-Oncology Ambulatory ServicePetah Tikva, Israel, 4941492 Hematology Division - Oncology PharmacyPetah Tikva, Israel, 4941492 Rabin Medical Center, Beilinson HospitalPetah Tikva, Israel, 4941492 Tel-Aviv Sourasky Medical CenterTel Aviv, Israel, 6423906|Torette Di Ancona, An, Italy, 60126|Torrette Di Ancona, Ancona, Italy, 60126|Bologna, Italy, 40138|Meldola, Fc, Italy, 47014|Cona, Ferrara, Fe, Italy, 44124 Farmacia OspedalieraFerrara, Fe, Italy, 44121|Pesaro, Pu, Italy, 61122|Roma, Rm, Italy, 00161|Siena, Si, Italy, 53100|Nagoya, Aichi, Japan, 466-8650|Akita, Japan, 010-8543 Kyushu University HospitalFukuoka, Japan, 812-8582 National Hospital Organization Kumamoto Medical Center[Active, Not Recruiting]Kumamoto, Japan, 860-0008 Nagasaki University HospitalNagasaki, Japan, 852-8501 Tokyo Medical University HospitalTokyo, Japan, 160-0023 Korea, Republic Of, Jeollabuk-Do Chonbuk National University HospitalJeonju-Si, Jeollabuk-Do, Korea, Republic Of, 54907 Korea, Republic Of, Jeollanam-Do Chonnam National University Hwasun HospitalHwasun-Gun, Jeollanam-Do, Korea, Republic Of, 58128 Korea, Republic Of Department Of Pharmacy, Inje University Busan Paik HospitalBusan, Korea, Republic Of, 47392 Inje University Busan Paik HospitalBusan, Korea, Republic Of, 47392 Clinical Trial Pharmacy, Keimyung University Dongsan HospitalDaegu, Korea, Republic Of, 42601 Keimyung University Dongsan HospitalDaegu, Korea, Republic Of, 42601 Gachon University Gil Medical CenterIncheon, Korea, Republic Of, 21565 Seoul National University HospitalSeoul, Korea, Republic Of, 03080 Severance Hospital, Yonsei University Health SystemSeoul, Korea, Republic Of, 03722 Department Of Pharmacy, Samsung Medical CenterSeoul, Korea, Republic Of, 06351 Samsung Medical CenterSeoul, Korea, Republic Of, 06351 The Catholic University Of Korea Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591 The Catholic University Of Korea, Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591|Yoshida-Gun, Fukui, Japan, 910-1193|Maebashi, Gunma, Japan, 371-8511|Kobe-Shi, Hyogo, Japan, 650-0017|Yokohama, Kanagawa, Japan, 232-0024|Sendai, Miyagi, Japan, 980-8574|Osaka-City, Osaka, Japan, 545-8586 Kindai University HospitalOsaka-Sayama, Osaka, Japan, 589-8511|Sunto-Gun, Shizuoka, Japan, 411-8777|Tachikawa, Tokyo, Japan, 190-0014|MÃ©xico, Mexico, 06726|MÃ©xico, MÃ©x, Mexico, 14080|Gdansk, Poland, 80-214 Wwcoit Im. M. Kopernika W LodziLodz, Poland, 93-513|Cluj-Napoca, Cluj, Romania, 400124|Craiova, Dolj, Romania, 200136|Bucuresti, Romania, 010825 Spitalul Clinic Coltea, Clinica De HematologieBucuresti, Romania, 030171 Russian Federation Sbhi Cch No. 40 Hd MoscowMoscow, Russian Federation, 129301 State Budgetary Healthcare Institution Of MoscowMoscow, Russian Federation, 129301 Sbhi Nnr Nn Rch N. A. N.A. SemashkoNizhniy Novgorod, Russian Federation, 603126 State Budgetary Institution Of Ryazan Region 'Regional Clinical Hospital' (Sbi Rr Rch)Ryazan, Russian Federation, 390039 Fsbi Russrhti Fmba Of|Barcelona, Spain, 08003 Hospital De La Santa Creu I Sant PauBarcelona, Spain, 08025 Hospital Universitario Arnau De VilanovaLleida, Spain, 25198 Hospital General Universitario Gregorio MaranonMadrid, Spain, 28007 Hospital Universitario Ramon Y CajalMadrid, Spain, 28034 Hospital Universitario Virgen Del RocioSevilla, Spain, 41013 Hospital Universitari I Politecnic La FeValencia, Spain, 46026|Goteborg, Sweden, 413 45 Apl, Apl Sahlgrenska, Kliniska ProvningarGoteborg, Sweden, 413 46 Apoex VnOrebro, Sweden, 701 85 Universitetssjukhuset OrebroOrebro, Sweden, 701 85 Karolinska Universitetssjukhuset HuddingeStockholm, Sweden, 141 86 Taiwan National Cheng Kung University HospitalTainan, Taiwan, 704 National Taiwan University HospitalTaipei, Taiwan, 100 Department Of Clinical Trial Pharmacy, Taipei Veterans General HospitalTaipei, Taiwan, 11217 Taipei Veterans General HospitalTaipei, Taiwan, 11217 Division Of Pharmacy, Koo Foundation Sun Yat-Sen Cancer CenterTaipei, Taiwan, 112 Koo Foundation Sun Yat-Sen Cancer CenterTaipei, Taiwan, 112 Chang Gung Memorial Hospital-Linkou BranchTaoyuan City, Taiwan, 333 Chemotherapy Pharmacy, Chang Gung Memorial Hospital-Linkou BranchTaoyuan City, Taiwan, 333|Sutton, Surrey, United Kingdom, Sm2 5Pt|Birmingham, West Midlands, United Kingdom, B15 2Th University Hospitals Birmingham Nhs Foundation TrustBirmingham, West Midlands, United Kingdom, B30 3Hg|London, United Kingdom, Ec1A 7Be Imperial College Healthcare Nhs TrustLondon, United Kingdom, W12 0Hs|Los Angeles, California, United States, 90033 Lac+Usc Medical CenterLos Angeles, California, United States, 90033 Usc/Norris Comprehensive Cancer Center / Investigational Drug ServicesLos Angeles, California, United States, 90033 Usc/Norris Comprehensive Cancer CenterLos Angeles, California, United States, 90033 Rrmc - UclaLos Angeles, California, United States, 90095 Ucla Department Of MedicineLos Angeles, California, United States, 90095 Ucla Hematology/Oncology ClinicLos Angeles, California, United States, 90095 Ucla Ronald Reagan Medical CenterLos Angeles, California, United States, 90095 Keck Medicine Of Usc Norris Oncology/Hematology - Newport Beach Treatment CenterNewport Beach, California, United States, 92663 Usc Norris Oncology/Hematology - Newport BeachNewport Beach, California, United States, 92663 Uc Irvine Health - Chao Family Comprehensive Cancer CenterOrange, California, United States, 92868-3201 Uc Irvine Medical CenterOrange, California, United States, 92868-3201 Ucsf Helen Diller Family Comprehensive Cancer CenterSan Francisco, California, United States, 94143 University Of California, San Francisco Medical CenterSan Francisco, California, United States, 94143 University Of California, San FranciscoSan Francisco, California, United States, 94143|Boston, Massachusetts, United States, 02111 Tufts Medical CenterBoston, Massachusetts, United States, 02111 Massachusetts General HospitalBoston, Massachusetts, United States, 02114 Beth|Kansas City, Missouri, United States, 64132|Lake Success, New York, United States, 11042 North Shore University HospitalManhasset, New York, United States, 11030 Long Island Jewish Medical CenterNew Hyde Park, New York, United States, 11040 University Of Rochester Cancer Center PharmacyRochester, New York, United States, 14642 University Of Rochester Medical CenterRochester, New York, United States, 14642|Cleveland, Ohio, United States, 44106 University Hospitals Cleveland Medical CenterCleveland, Ohio, United States, 44106 Cleveland Clinic FoundationCleveland, Ohio, United States, 44195|Portland, Oregon, United States, 97239 Oregon Health & Science University-Research Pharmacy ServicesPortland, Oregon, United States, 97239 Oregon Health & Science UniversityPortland, Oregon, United States, 97239|Nashville, Tennessee, United States, 37203 The Sarah Cannon Research InstituteNashville, Tennessee, United States, 37203|Dallas, Texas, United States, 75246 Baylor University Medical CenterDallas, Texas, United States, 75246 The University Of Texas, Md Anderson Cancer CenterHouston, Texas, United States, 77030 Blood Cancer And Stem Cell Transplant ClinicSan Antonio, Texas, United States, 78229 Methodist Healthcare System Of San AntonioSan Antonio, Texas, United States, 78229 Methodist Hospital Investigational PharmacySan Antonio, Texas, United States, 78229|Seattle, Washington, United States, 98104 Swedish Investigational Drug Services PharmacySeattle, Washington, United States, 98104 Swedish Medical CenterSeattle, Washington, United States, 98122","California|Massachusetts|Missouri|New York|Ohio|Oregon|Tennessee|Texas|Washington","Australia|Austria|Belgium|Canada|China|Czechia|France|Germany|Hungary|Israel|Italy|Japan|Mexico|Poland|Romania|Spain|Sweden|United Kingdom|United States","Australia, 5000 Royal Adelaide Hospital|New South Wales St Vincent's Hospital Sydney|Royal Adelaide Hospital - Clinical Trials Pharmacy|Klinikum Wels-Grieskirchen Gmbh|Landeskrankenhaus Salzburg, Universitatsklinik Fur Innere Medizin Iii Der Pmu|Az Sint-Jan Brugge - Oostende Av|Manitoba Health Sciences Centre|Ontario Sunnybrook Research Institute|Quebec Ciusss De L'Est-De-L'Ile-De- MontrÃ©al - HÃ´pital Maisonneuve-Rosemont|Fujian Fujian Medical University Union Hospital|Guangdong Guangdong Provincial People's Hospital|Henan Henan Cancer Hostipal|Hospital, Sichuan University|Hubei Tongji Hospital, Tongji Medical College, Huazhong University Of Science & Technology/Cancer Center|Jiangsu Jiangsu Province Hospital|Shandong Affiliated Hospital Of Qingdao University/Hematology Department|Shanghai Shanghai General Hospital|Tianjin Institute Of Hematology And Blood Diseases Hospital, Chinese Academy Of Medical Sciences|Zhejiang The First Affiliated Hospital College Of Medicine, Zhejiang University|Interni Hematologicka A Onkologicka Klinika, Fakultni Nemocnice Brno|Chu Henri Mondor|Medizinische Hochschule Hannover|North Rhine Westphalia UniversitÃ¤tsklinikum KÃ¶ln|Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Klinika, Hematologia Tanszek|Deaconess Medical Center|Rambam Health Care Campus|An Sod Farmacia-Dipt Dei Servizi -Aou Ospedali Riuniti Umberto I, G.M. Lancisi, G. Salesi|Ancona Aou Ospedali Riuniti Umberto I, G.M. Lancisi, G. Salesi, Clinica Di Ematologia|Azienda Ospedaliero Universitaria Di Bologna Policlinico S.Orsola Malpighi|Fc Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori|Fe A.O.U. Di Ferrara- Arcispedale Sant'Anna,|Pu Ao Ospedali Riuniti Marche Nord - Presidio Ospedaliero San Salvatore Di Pesaro -|Rm Azienda Ospedaliero Universitaria Policlinico Umberto I|Si Azienda Ospedaliera Universitaria Senese.|Aichi Japanese Red Cross Nagoya Daini Hospital|Akita University Hospital|Fukui University Of Fukui Hospital|Gunma Gunma University Hospital|Hyogo Kobe University Hospital|Kanagawa Yokohama City University Medical Center|Miyagi Tohoku University Hospital|Osaka Osaka City University Hospital|Shizuoka Shizuoka Cancer Center|Tokyo National Hospital Organization Disaster Medical Center|Hospital General De MÃ©xico Dr. Eduardo Liceaga|MÃ©x Instituto Nacional De CancerologÃ­a|Klinika Hematologii I Transplantologii Uniwersyteckie Centrum Kliniczne|Cluj Institutul Oncologic 'Prof. Dr. Ion Chiricuta'|Dolj Spitalul Clinic Municipal Filantropia Craiova, Sectia Clinica Hematologie|Spitalul Universitar De Urgenta Militar Central \"Dr. Carol Davila\" Bucuresti|Hospital Del Mar|Sektionen For Hematologi Och Koagulation|, Surrey The Royal Marsden Nhs Foundation Trust|, West Midlands University Hospitals Birmingham Nhs Foundation Trust|Barts Health Nhs Trust|Keck Hospital Of Usc|Tufts Medical Center Investigational Pharmacy|Midamerica Division, Inc., C/O Research Medical Center|Northwell Health/Monter Cancer Center|Taussig Cancer Center Investigational Pharmacy|Ohsu Center For Health And Healing|Centennial Medical Center|Baylor Scott And White Research Institute|Swedish Cancer Institute",{"$nulls":3},"Pfizer CT.gov Call Center","2019-08-17","2020-05-25T16:39:37.865","2020-05-26T17:10:42.972","NCT03416179"]
["5ecbf4ca11702c1b1b916bce","NCT03416179","2019-09-06","Pfizer","PFE","Recruiting","A Study Evaluating Intensive Chemotherapy With or Without Glasdegib or Azacitidine With or Without Glasdegib In Patients With Previously Untreated Acute Myeloid Leukemia (BRIGHT AML1019)","Glasdegib|Cytarabine|Daunorubicin|Azacitidine","Hh Inhibitor|DNA Polymerase Inhibitor|Nucleic Acid Synthesis Inhibitor|TOP2 Inhibitor|DNA Mtase Inhibitor","Unknown",null,"Unknown",null,"Phase 3",4,720,"Anticipated","2018-04-20","2021-06-13","OS","Overall Survival",{"$nulls":3},"Glasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).\n\nGlasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).","Two separate registration trials conducted under one protocol number are proposed to adequately and independently evaluate the addition of glasdegib in intensive and non-intensive chemotherapy populations. Each study will have an experimental treatment arm and a placebo arm. Endpoints are the same for each study except where specifically indicated.\n\nAssignment to the Intensive Study or the Non-Intensive Study will be made by the Investigator based on the 2017 European LeukemiaNet (ELN) recommendations.\n\nStudy B1371019 is a randomized (1:1), double-blind, multi-center, placebo controlled study of chemotherapy in combination with glasdegib versus chemotherapy in combination with placebo in adult patients with previously untreated AML.\n\nGlasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).\n\nGlasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).","A RANDOMIZED (1:1), DOUBLE-BLIND, MULTI-CENTER, PLACEBO CONTROLLED STUDY EVALUATING INTENSIVE CHEMOTHERAPY WITH OR WITHOUT GLASDEGIB (PF-04449913) OR AZACITIDINE (AZA) WITH OR WITHOUT GLASDEGIB IN PATIENTS WITH PREVIOUSLY UNTREATED ACUTE MYELOID LEUKEMIA","B1371019","Leukemia, Myeloid, Acute","Acute Leukemia|Acute Myeloid Leukemia|Myeloid Leukemia|Leukemia","Oncology Hematological","Oncology","Experimental|Placebo Comparator","Arm A (Intensive Study)|Arm B (Intensive Study)|Arm A (Non-intensive study)|Arm B (Non-intensive study)","Glasdegib + '7+3' Induction(s)|Placebo + '7+3' Induction(s)|Glasdegib + azacitidine|Placebo + azacitidine","Drug|Procedure","glasdegib|daunorubicin + cytarabine|cytarabine|HSCT|Placebo|azacitidine","Daily Glasdegib (100 mg, PO), beginning on Day 1 and is to continue up to 2 years post randomization.\n\nFollowing consolidation therapy, glasdegib or placebo will be administered daily for up to 2 years after randomization or until they have minimal residual disease (MRD) negative disease, whichever comes first.\n\nDaily Glasdegib (100 mg, PO) or matching placebo will continue throughout Induction(s) and Consolidation therapies regardless of dose modifications/delays in the chemotherapy.|Consolidation with single agent cytarabine 3 g/m2 IV for adults <60 years and 1 g/m2 for adults 60 years over 3 BID on Days 1, 3, and 5, every 28 days for up to 4 cycles or alternative single agent cytarabine consolidation schedules may be used per local prescribing information.|If required, and done per standard of care post Induction(s).|Azacitidine (75 mg/m2, SC or IV) daily for 7 days, in 28 day cycles for as long as they do not meet the criteria for disease progression, unacceptable toxicity, consent withdrawal, or death.|Matching placebo (PO) is to be administered by mouth daily beginning on Day 1 of chemotherapy and will continue if subjects demonstrate reasonable evidence of clinical benefit and do not meet the criteria for progression regardless of any delays/modifications in the chemotherapy treatment. Subjects will continue placebo until disease progression, unacceptable toxicity, consent withdrawal, or death, whichever comes first.","PF-04449913","Arm A (Intensive Study)|Arm B (Intensive Study)|Arm A (Non-intensive study)|Arm B (Non-intensive study)","\n\nSubjects must meet all of the following inclusion criteria to be eligible for enrollment into the Intensive and Non Intensive study (unless where indicated):\n\n 1.  Subjects with untreated AML according to the World Health Organization (WHO) 2016 Classification2, including those with: * AML arising from MDS or another antecedent hematologic disease (AHD).\n      * AML after previous cytotoxic therapy or radiation (secondary AML).\n     \n     \n 2.  18 years of age (In Japan, 20 years of age).\n 3.  Adequate Organ Function as defined by the following: * Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) 3 x upper limit of normal (ULN), excluding subjects with liver function abnormalities due to underlying malignancy.\n      * Total serum bilirubin 2 x ULN (except subjects with documented Gilbert's syndrome).\n      * Estimated creatinine clearance 30 mL/min as calculated using the standard method for the institution.\n     \n     \n 4.  QTc interval 470 msec using the Fridericia correction (QTcF).\n 5.  All anti cancer treatments (unless specified) should be discontinued 2 weeks from study entry, for example: targeted chemotherapy, radiotherapy, investigational agents, hormones, anagrelide or cytokines. * For control of rapidly progressing leukemia, all trans retinoic acid (ATRA), hydroxyurea, and/or leukopheresis may be used before and for up to 1 week after the first dose of glasdegib.\n     \n     \n 6.  Serum or urine pregnancy test (for female subjects of childbearing potential) with a minimum sensitivity of 25 IU/L or equivalent units of human chorionic gonadotropin (hCG) negative at screening.\n 7.  Male and female subjects of childbearing potential and at risk for pregnancy must agree to use at least one highly effective method of contraception throughout the study and for 180 days after the last dose of azacitidine, cytarabine, or daunorubicin; and the last dose of glasdegib or placebo, whichever occurs later.\n 8.  Female subjects of non childbearing potential must meet at least 1 of the following criteria: 1. Have undergone a documented hysterectomy and/or bilateral oophorectomy;\n      2. Have medically confirmed ovarian failure; or\n      3. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; status may be confirmed by having a serum follicle stimulating hormone (FSH) level confirming the postmenopausal state.\n     \n     All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential.\n     \n     \n 9.  Consent to a saliva sample collection for a germline comparator, unless prohibited by local regulations or ethics committee (EC) decision.\n 10. Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.\n 11. Subjects who are willing and able to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures (including bone marrow [BM] assessments).\n\n","\n\nSubjects with any of the following characteristics/conditions will not be included in the study:\n\n 1.  Acute Promyelocytic Leukemia (APL) and APLwith PML RARA, subjects (WHO 2016 classification).\n 2.  AML with BCR ABL1 or t(9;22)(q34;q11.2) as a sole abnormality. * Complex genetics may include t(9;22) cytogenetic translocation.\n     \n     \n 3.  Subjects with known active CNS leukemia.\n 4.  Participation in other clinical studies involving other investigational drug(s) (Phases 1 4) within 4 weeks prior study entry and/or during study participation.\n 5.  Subjects known to be refractory to platelet or packed red cell transfusions per Institutional Guidelines, or a patient who refuses blood product support.\n 6.  Subjects with another active malignancy on treatment with the exception of basal cell carcinoma, non melanoma skin cancer, cervical carcinoma in situ. Other prior or concurrent malignancies will be considered on a case by case basis.\n 7.  Any one of the following ongoing or in the previous 6 months: myocardial infarction, congenital long QT syndrome, Torsades de pointes, symptomatic arrhythmias (including sustained ventricular tachyarrhythmia), right or left bundle branch block and bifascicular block, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (CHF New York Heart Association class III or IV), cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism; as well as bradycardia defined as <50 bpms.\n 8.  Subjects with an active, life threatening or clinically significant uncontrolled systemic infection not related to AML.\n 9.  Subjects with left ventricular ejection fraction (LVEF) <50% are excluded from the Intensive Chemotherapy Study only.\n 10. Cumulative anthracycline dose equivalent of 550 mg/m2 of daunorubicin for the Intensive Chemotherapy Study only.\n 11. Known malabsorption syndrome or other condition that may significantly impair absorption of study medication in the investigator's judgment (eg, gastrectomy, lap band, Crohn's disease) and inability or unwillingness to swallow tablets or capsules.\n 12. Current use or anticipated requirement for drugs that are known strong CYP3A4/5 inducers.\n 13. Concurrent administration of herbal preparations.\n 14. Major surgery or radiation within 4 weeks of starting study treatment.\n 15. Documented or suspected hypersensitivity to any one of the following: * For subjects assigned to intensive chemotherapy, documented or suspected hypersensitivity to cytarabine (not including drug fever or exanthema, including known cerebellar side effects) or daunorubicin.\n      * For subjects assigned to non intensive chemotherapy, documented or suspected hypersensitivity to azacitidine or mannitol.\n     \n     \n 16. Known active drug or alcohol abuse.\n 17. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.\n 18. Pregnant females or breastfeeding female subjects.\n 19. Known recent or active suicidal ideation or behavior.\n 20. Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.","FSH",null,"Protein","Ovary","Actual","2018-01-31","Actual","Anticipated","2025-07-22","Anticipated","2019-09-01","2017-12-21","2018-01-23","2019-09-04","Yes","glasdegib;\nuntreated;\nHedgehog Inhibitor","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"All",null,"No","Yes\nPfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",null,"URL: https://pmiform.com/clinical-trial-info-request?StudyID=B1371019 [https://pmiform.com/clinical-trial-info-request?StudyID=B1371019] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To obtain contact information for a study center near you, click here.",null,"Yes","No",{"$nulls":17},"2017-002822-19|BRIGHT|BRIGHT AML1019","EudraCT Number|Alias Study Number","Overall survival","5 years after last subject randomized",null,"Fatigue score measured by the MD Anderson Symptom Inventory (MDASI)-AML/MDS questionnaire|Rate of Complete Remission (CR) (including CR with minimal residual disease (MRD)-negative as assessed by multiparametric flow cytometry)|Duration of response (defined as CR [includes CR-MRD negative]/CRi or CR/CRh as appropriate)|Time to response (CR[includes CR-MRD negative)]/CR with partial hematologic rcovery (CRh) as appropriate)|Event-free Survival|Patient Reported Outcomes (PROs) as measured by the M.D. Anderson Symptom Inventory AML/MDS Module (MDASI-AML/MDS)|Adverse events as graded by NCI CTCAE v4.03|Laboratory abnormalities as graded by NCI CTCAE v4.03|For the intensive study, the plasma trough concentration (Ctrough) will be analyzed|QTc interval|PROs as measured by Patient Global Impression of Change (PGIC)|Patient Reported Outcomes (PROs) as measured by EuroQoL 5 Dimension questionnaire 5-Level version (EQ-5D-5L)|Patient Reported Outcomes (PROs) as measured by Patient Global Impression of Symptoms (PGIS)|Complete Remission with incomplete hematologic recovery (CRi)|Rate of morphological leukemia-free state (MLFS)|Rate of Partial Remission (PR)|Rate of Complete Remission with partial hematological recovery (CRh) for the Non-intensive study only only|Minimum Observed Plasma Trough Concentratrion of glasdegib in the Intensive Study|Minimum Observed Plasma Trough Concentration of glasdegib in the Non-intensive study","Scale is from 0-10 where 0 is not present and 10 is as bad as you can image.|Response as defined by the 2017 European LeukemiaNet (ELN) recommendations.|5 years after last subject randomized, consent withdrawal, or death|Measurement Scale from 0-10.|PK samples taken on Induction(s) Day 1 (1 and 4 hours post induction); Induction(s) Day 10 (pre-dose, 1 and 4 hours post dose); Day 1 of each Consolidation cycle (pre-dose, 1 and 4 hours post dose)|One question asking for description of leukemia symptoms.|Series of questions that ask for information that best describes health.|One question asking for information regarding leukemia symptoms.|Its the minimum trough concentration in plasma of glasdegib following multiple daily dosing to steady state.|It is the minimum trough concentration in plasma of glasdegib following multiple daily dosing to steady state.","5 years after last subject randomized, consent withdrawal, or death|2 years after last dose of study therapy|5 years after last patient randomized, withdrawal, or death|5 years after last subject randomized, withdrawal, or death|Day 10 of Induction Cycle and Day 1 of each Consolidation Cycle|Cycle 1 Day 15 and Cycles 2 and 3 on Day 1","ClinicalTrials.gov_Inquiries@pfizer.com","Pfizer CT.gov Call Center","1-800-718-1021","Adelaide, South|Darlinghurst, New South Wales, Australia, 2010 St George HospitalKogarah, New South Wales, Australia, 2217|Wels, Upper|Salzburg, Austria, 5020 Uniklinikum Salzburg, Landeskrankenhaus SalzburgSalzburg, Austria, 5020 Klinikum Wels-Grieskirchen GmbhWels, Austria, 4600 Sozialmedizinisches Zentrum Sud.Wien, Austria, 1100 Krankenhaus Hietzing Mit Neurologischem Zentrum RosenhugelWien, Austria, 1130|Brugge, Belgium, B-8000 Az Sint-Jan Brugge-Oostende AvBrugge, Belgium, B-8000 Universitaire Ziekenhuizen Brussel (Uz Brussel)Brussels, Belgium, B-1090 Universitaire Ziekenhuizen BrusselBrussels, Belgium, B-1090 Universitaire Ziekenhuizen LeuvenLeuven, Belgium, B-3000|Winnipeg, Manitoba, Canada, R3A 1R9 Cancercare ManitobaWinnipeg, Manitoba, Canada, R3E 0V9|Toronto, Ontario, Canada, M4N 3M5 Princess Margaret Cancer CentreToronto, Ontario, Canada, M5G 2M9|Montreal, Quebec, Canada, H1T 2M4|Fuzhou, Fujian, China, 350001|Guangzhou, Guangdong, China, 510080 Guangdong Second Provincial General HospitalGuangzhou, Guangdong, China, 510317|Zhengzhou, Henan, China, 450008|Chengdu, Sichuan, China, 610041|Wuhan, Hubei, China, 430030|Nanjing, Jiangsu, China, 210029|Qingdao, Shandong, China, 266071|Shanghai, Shanghai, China, 200080|Tianjin, Tianjin, China, 300020|Hangzhou, Zhejiang, China, 310003|Brno, Czechia, 100 34 Nemocnicni LekarnaBrno, Czechia, 625 00 Ustavni LekarnaOstrava - Poruba, Czechia, 708 52 Klinika HematoonkologieOstrava-Poruba, Czechia, 708 52 InternÃ­ HematologickÃ¡ Klinika, Fakultni Nemocnice KrÃ¡lovskÃ© VinohradyPraha 10, Czechia, 100 34 Ãšstavni LÃ©kÃ¡rnaPraha 10, Czechia, 100 34|Creteil, France, 94010 Chu Henri MondorCrÃ©teil, France, 94010 Chu De NantesNantes Cedex 1, France, 44093 Chu De Nantes Hotel DieuNantes Cedex, France, 44093 Hopital Saint LouisParis, France, 75010 Centre Hospitalier Lyon Sud - Service D'HematologiePierre Benite Cedex, France, 69495 Centre Hospitalier Lyon Sud -Unite De Pharmacie Clinique OncologiquePierre Benite Cedex, France, 69495 Institut Gustave RoussyVillejuif Cedex, France, 94805|Hannover, Germany, 30625 UniversitÃ¤tsklinikum KÃ¶lnKoeln, Germany, 50937 Philipps-Universitaet MarburgMarburg, Germany, 35032|Koeln, North Rhine Westphalia, Germany, 50937|Muenster, North-Rhine-Westphalia, Germany, 48149|Debrecen, Hungary, 4032 Debreceni Egyetem Klinikai Kozpont Belgyogyaszati KlinikaDebrecen, Hungary, 4032 Petz AladÃ¡r Megyei OktatÃ³ KÃ³rhÃ¡z, GyÃ³gyszerÃ©szeti OsztÃ¡lyGyÅ‘r, Hungary, 9024 Petz AladÃ¡r Megyei OktatÃ³ KÃ³rhÃ¡z, Ii. BelgyÃ³gyÃ¡szat- HematolÃ³giai OsztÃ¡lyGyÅ‘r, Hungary, 9024 Somogy Megyei Kaposi Mor Oktato KorhazKaposvar, Hungary, 7400 Szabolcs-Szatmar Bereg Megyei Korhazak Es Egyetemi Oktatokorhaz, Josa Andras Korhaz, HematologiaNyiregyhaza, Hungary, 4400 Szabolcs-Szatmar Bereg Megyei Korhazak Es Egyetemi Oktatokorhaz, Josa Andras Korhaz,Nyiregyhaza, Hungary, 4400|Boston, Massachusetts, United States, 02215|Haifa, Israel, 3109601 Shaare Zedek Medical CenterJerusalem, Israel, 9103102 Hadassah Medical Center (Ein Kerem)Jerusalem, Israel, 91120 Hemato-Oncology Ambulatory ServicePetah Tikva, Israel, 4941492 Hematology Division - Oncology PharmacyPetah Tikva, Israel, 4941492 Rabin Medical Center, Beilinson HospitalPetah Tikva, Israel, 4941492 Tel-Aviv Sourasky Medical CenterTel Aviv, Israel, 6423906|Torette Di Ancona, An, Italy, 60126|Torrette Di Ancona, Ancona, Italy, 60126|Bologna, Italy, 40138|Meldola, Fc, Italy, 47014|Cona, Ferrara, Fe, Italy, 44124 Farmacia OspedalieraFerrara, Fe, Italy, 44121|Pesaro, Pu, Italy, 61122|Roma, Rm, Italy, 00161|Siena, Si, Italy, 53100|Nagoya, Aichi, Japan, 466-8650|Akita, Japan, 010-8543 Kyushu University HospitalFukuoka, Japan, 812-8582 National Hospital Organization Kumamoto Medical Center[Active, Not Recruiting]Kumamoto, Japan, 860-0008 Nagasaki University HospitalNagasaki, Japan, 852-8501 Tokyo Medical University HospitalTokyo, Japan, 160-0023 Korea, Republic Of, Jeollabuk-Do Chonbuk National University HospitalJeonju-Si, Jeollabuk-Do, Korea, Republic Of, 54907 Korea, Republic Of, Jeollanam-Do Chonnam National University Hwasun HospitalHwasun-Gun, Jeollanam-Do, Korea, Republic Of, 58128 Korea, Republic Of Department Of Pharmacy, Inje University Busan Paik HospitalBusan, Korea, Republic Of, 47392 Inje University Busan Paik HospitalBusan, Korea, Republic Of, 47392 Clinical Trial Pharmacy, Keimyung University Dongsan HospitalDaegu, Korea, Republic Of, 42601 Keimyung University Dongsan HospitalDaegu, Korea, Republic Of, 42601 Gachon University Gil Medical CenterIncheon, Korea, Republic Of, 21565 Seoul National University HospitalSeoul, Korea, Republic Of, 03080 Clinical Trial Center, Severance Hospital, Yonsei University Health SystemSeoul, Korea, Republic Of, 03722 Severance Hospital, Yonsei University Health SystemSeoul, Korea, Republic Of, 03722 Department Of Pharmacy, Samsung Medical CenterSeoul, Korea, Republic Of, 06351 Samsung Medical CenterSeoul, Korea, Republic Of, 06351 Department Of Pharmacy, Severance Hospital, Yonsei University Health SystemSeoul, Korea, Republic Of, 06591 The Catholic University Of Korea Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591 The Catholic University Of Korea, Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591|Yoshida-Gun, Fukui, Japan, 910-1193|Maebashi, Gunma, Japan, 371-8511|Kobe-Shi, Hyogo, Japan, 650-0017|Yokohama, Kanagawa, Japan, 232-0024|Sendai, Miyagi, Japan, 980-8574|Osaka-City, Osaka, Japan, 545-8586 Kindai University HospitalOsaka-Sayama, Osaka, Japan, 589-8511|Sunto-Gun, Shizuoka, Japan, 411-8777|Tachikawa, Tokyo, Japan, 190-0014|MÃ©xico, Mexico, 06726|MÃ©xico, MÃ©x, Mexico, 14080|Gdansk, Poland, 80-214 Wwcoit Im. M. Kopernika W LodziLodz, Poland, 93-513|Cluj-Napoca, Cluj, Romania, 400124|Craiova, Dolj, Romania, 200136|Bucuresti, Romania, 010825 Spitalul Clinic Coltea, Clinica De HematologieBucuresti, Romania, 030171 Russian Federation Sbhi Cch No. 40 Hd MoscowMoscow, Russian Federation, 129301 State Budgetary Healthcare Institution Of MoscowMoscow, Russian Federation, 129301 Sbhi Nnr Nn Rch N. A. N.A. SemashkoNizhniy Novgorod, Russian Federation, 603126 State Budgetary Institution Of Ryazan Region 'Regional Clinical Hospital' (Sbi Rr Rch)Ryazan, Russian Federation, 390039 Fsbi Russrhti Fmba Of|Barcelona, Spain, 08003 Hospital De La Santa Creu I Sant PauBarcelona, Spain, 08025 Hospital Universitario Arnau De VilanovaLleida, Spain, 25198 Hospital General Universitario Gregorio MaranonMadrid, Spain, 28007 Hospital Universitario Ramon Y CajalMadrid, Spain, 28034 Hospital Universitario Virgen Del RocioSevilla, Spain, 41013 Hospital Universitari I Politecnic La FeValencia, Spain, 46026|Goteborg, Sweden, 413 45 Apl, Apl Sahlgrenska, Kliniska ProvningarGoteborg, Sweden, 413 46 Apoex VnOrebro, Sweden, 701 85 Universitetssjukhuset OrebroOrebro, Sweden, 701 85 Karolinska Universitetssjukhuset HuddingeStockholm, Sweden, 141 86 Taiwan National Cheng Kung University HospitalTainan, Taiwan, 704 National Taiwan University HospitalTaipei, Taiwan, 100 Department Of Clinical Trial Pharmacy, Taipei Veterans General HospitalTaipei, Taiwan, 11217 Taipei Veterans General HospitalTaipei, Taiwan, 11217 Division Of Pharmacy, Koo Foundation Sun Yat-Sen Cancer CenterTaipei, Taiwan, 112 Koo Foundation Sun Yat-Sen Cancer CenterTaipei, Taiwan, 112 Chang Gung Memorial Hospital-Linkou BranchTaoyuan City, Taiwan, 333 Chemotherapy Pharmacy, Chang Gung Memorial Hospital-Linkou BranchTaoyuan City, Taiwan, 333|Sutton, Surrey, United Kingdom, Sm2 5Pt|Birmingham, West Midlands, United Kingdom, B15 2Th University Hospitals Birmingham Nhs Foundation TrustBirmingham, West Midlands, United Kingdom, B30 3Hg|London, United Kingdom, Ec1A 7Be Imperial College Healthcare Nhs TrustLondon, United Kingdom, W12 0Hs|Los Angeles, California, United States, 90033 Lac+Usc Medical CenterLos Angeles, California, United States, 90033 Usc/Norris Comprehensive Cancer Center / Investigational Drug ServicesLos Angeles, California, United States, 90033 Usc/Norris Comprehensive Cancer CenterLos Angeles, California, United States, 90033 Rrmc - UclaLos Angeles, California, United States, 90095 Ucla Department Of MedicineLos Angeles, California, United States, 90095 Ucla Hematology/Oncology ClinicLos Angeles, California, United States, 90095 Ucla Ronald Reagan Medical CenterLos Angeles, California, United States, 90095 Keck Medicine Of Usc Norris Oncology/Hematology - Newport Beach Treatment CenterNewport Beach, California, United States, 92663 Usc Norris Oncology/Hematology - Newport BeachNewport Beach, California, United States, 92663 Uc Irvine Health - Chao Family Comprehensive Cancer CenterOrange, California, United States, 92868-3201 Uc Irvine Medical CenterOrange, California, United States, 92868-3201 Ucsf Helen Diller Family Comprehensive Cancer CenterSan Francisco, California, United States, 94143 University Of California, San Francisco Medical CenterSan Francisco, California, United States, 94143 University Of California, San FranciscoSan Francisco, California, United States, 94143|Boston, Massachusetts, United States, 02111 Tufts Medical CenterBoston, Massachusetts, United States, 02111 Massachusetts General HospitalBoston, Massachusetts, United States, 02114 Beth|Kansas City, Missouri, United States, 64132|Lake Success, New York, United States, 11042 North Shore University HospitalManhasset, New York, United States, 11030 Long Island Jewish Medical CenterNew Hyde Park, New York, United States, 11040 University Of Rochester Cancer Center PharmacyRochester, New York, United States, 14642 University Of Rochester Medical CenterRochester, New York, United States, 14642|Cleveland, Ohio, United States, 44106 University Hospitals Cleveland Medical CenterCleveland, Ohio, United States, 44106 Cleveland Clinic FoundationCleveland, Ohio, United States, 44195|Portland, Oregon, United States, 97239 Oregon Health & Science University-Research Pharmacy ServicesPortland, Oregon, United States, 97239 Oregon Health & Science UniversityPortland, Oregon, United States, 97239|Nashville, Tennessee, United States, 37203 The Sarah Cannon Research InstituteNashville, Tennessee, United States, 37203|Dallas, Texas, United States, 75246 Baylor University Medical CenterDallas, Texas, United States, 75246 The University Of Texas, Md Anderson Cancer CenterHouston, Texas, United States, 77030 Blood Cancer And Stem Cell Transplant ClinicSan Antonio, Texas, United States, 78229 Methodist Healthcare System Of San AntonioSan Antonio, Texas, United States, 78229 Methodist Hospital Investigational PharmacySan Antonio, Texas, United States, 78229|Seattle, Washington, United States, 98104 Swedish First Hill Ids PharmacySeattle, Washington, United States, 98104 Swedish Medical CenterSeattle, Washington, United States, 98122","California|Massachusetts|Missouri|New York|Ohio|Oregon|Tennessee|Texas|Washington","Australia|Austria|Belgium|Canada|China|Czechia|France|Germany|Hungary|Israel|Italy|Japan|Mexico|Poland|Romania|Spain|Sweden|United Kingdom|United States","Australia, 5000 Royal Adelaide Hospital|New South Wales St Vincent's Hospital Sydney|Royal Adelaide Hospital - Clinical Trials Pharmacy|Klinikum Wels-Grieskirchen Gmbh|Landeskrankenhaus Salzburg, Universitatsklinik Fur Innere Medizin Iii Der Pmu|Az Sint-Jan Brugge - Oostende Av|Manitoba Health Sciences Centre|Ontario Sunnybrook Research Institute|Quebec Ciusss De L'Est-De-L'Ile-De- MontrÃ©al - HÃ´pital Maisonneuve-Rosemont|Fujian Fujian Medical University Union Hospital|Guangdong Guangdong Provincial People's Hospital|Henan Henan Cancer Hostipal|Hospital, Sichuan University|Hubei Tongji Hospital, Tongji Medical College, Huazhong University Of Science & Technology/Cancer Center|Jiangsu Jiangsu Province Hospital|Shandong Affiliated Hospital Of Qingdao University/Hematology Department|Shanghai Shanghai General Hospital|Tianjin Institute Of Hematology And Blood Diseases Hospital, Chinese Academy Of Medical Sciences|Zhejiang The First Affiliated Hospital College Of Medicine, Zhejiang University|Interni Hematologicka A Onkologicka Klinika, Fakultni Nemocnice Brno|Chu Henri Mondor|Medizinische Hochschule Hannover|North Rhine Westphalia UniversitÃ¤tsklinikum KÃ¶ln|North-Rhine-Westphalia Universitaetsklinikum Muenster|Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Klinika, Hematologia Tanszek|Deaconess Medical Center|Rambam Health Care Campus|An Sod Farmacia-Dipt Dei Servizi -Aou Ospedali Riuniti Umberto I, G.M. Lancisi, G. Salesi|Ancona Aou Ospedali Riuniti Umberto I, G.M. Lancisi, G. Salesi, Clinica Di Ematologia|Azienda Ospedaliero Universitaria Di Bologna Policlinico S.Orsola Malpighi|Fc Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori|Fe A.O.U. Di Ferrara- Arcispedale Sant'Anna,|Pu Ao Ospedali Riuniti Marche Nord - Presidio Ospedaliero San Salvatore Di Pesaro -|Rm Azienda Ospedaliero Universitaria Policlinico Umberto I|Si Azienda Ospedaliera Universitaria Senese.|Aichi Japanese Red Cross Nagoya Daini Hospital|Akita University Hospital|Fukui University Of Fukui Hospital|Gunma Gunma University Hospital|Hyogo Kobe University Hospital|Kanagawa Yokohama City University Medical Center|Miyagi Tohoku University Hospital|Osaka Osaka City University Hospital|Shizuoka Shizuoka Cancer Center|Tokyo National Hospital Organization Disaster Medical Center|Hospital General De MÃ©xico Dr. Eduardo Liceaga|MÃ©x Instituto Nacional De CancerologÃ­a|Klinika Hematologii I Transplantologii Uniwersyteckie Centrum Kliniczne|Cluj Institutul Oncologic 'Prof. Dr. Ion Chiricuta'|Dolj Spitalul Clinic Municipal Filantropia Craiova, Sectia Clinica Hematologie|Spitalul Universitar De Urgenta Militar Central \"Dr. Carol Davila\" Bucuresti|Hospital Del Mar|Sektionen For Hematologi Och Koagulation|, Surrey The Royal Marsden Nhs Foundation Trust|, West Midlands University Hospitals Birmingham Nhs Foundation Trust|Barts Health Nhs Trust|Keck Hospital Of Usc|Tufts Medical Center Investigational Pharmacy|Midamerica Division, Inc., C/O Research Medical Center|Northwell Health/Monter Cancer Center|Taussig Cancer Center Investigational Pharmacy|Ohsu Center For Health And Healing|Centennial Medical Center|Baylor Scott And White Research Institute|Swedish Cancer Institute",{"$nulls":3},"Pfizer CT.gov Call Center","2019-09-04","2020-05-25T16:39:38.333","2020-05-26T17:10:42.972","NCT03416179"]
["5ecbf4cafeab101b155309f1","NCT03416179","2019-09-10","Pfizer","PFE","Recruiting","A Study Evaluating Intensive Chemotherapy With or Without Glasdegib or Azacitidine With or Without Glasdegib In Patients With Previously Untreated Acute Myeloid Leukemia (BRIGHT AML1019)","Glasdegib|Cytarabine|Daunorubicin|Azacitidine","Hh Inhibitor|DNA Polymerase Inhibitor|Nucleic Acid Synthesis Inhibitor|TOP2 Inhibitor|DNA Mtase Inhibitor","Unknown",null,"Unknown",null,"Phase 3",4,720,"Anticipated","2018-04-20","2021-06-13","OS","Overall Survival",{"$nulls":3},"Glasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).\n\nGlasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).","Two separate registration trials conducted under one protocol number are proposed to adequately and independently evaluate the addition of glasdegib in intensive and non-intensive chemotherapy populations. Each study will have an experimental treatment arm and a placebo arm. Endpoints are the same for each study except where specifically indicated.\n\nAssignment to the Intensive Study or the Non-Intensive Study will be made by the Investigator based on the 2017 European LeukemiaNet (ELN) recommendations.\n\nStudy B1371019 is a randomized (1:1), double-blind, multi-center, placebo controlled study of chemotherapy in combination with glasdegib versus chemotherapy in combination with placebo in adult patients with previously untreated AML.\n\nGlasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).\n\nGlasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).","A RANDOMIZED (1:1), DOUBLE-BLIND, MULTI-CENTER, PLACEBO CONTROLLED STUDY EVALUATING INTENSIVE CHEMOTHERAPY WITH OR WITHOUT GLASDEGIB (PF-04449913) OR AZACITIDINE (AZA) WITH OR WITHOUT GLASDEGIB IN PATIENTS WITH PREVIOUSLY UNTREATED ACUTE MYELOID LEUKEMIA","B1371019","Leukemia, Myeloid, Acute","Acute Leukemia|Acute Myeloid Leukemia|Myeloid Leukemia|Leukemia","Oncology Hematological","Oncology","Experimental|Placebo Comparator","Arm A (Intensive Study)|Arm B (Intensive Study)|Arm A (Non-intensive study)|Arm B (Non-intensive study)","Glasdegib + '7+3' Induction(s)|Placebo + '7+3' Induction(s)|Glasdegib + azacitidine|Placebo + azacitidine","Drug|Procedure","glasdegib|daunorubicin + cytarabine|cytarabine|HSCT|Placebo|azacitidine","Daily Glasdegib (100 mg, PO), beginning on Day 1 and is to continue up to 2 years post randomization.\n\nFollowing consolidation therapy, glasdegib or placebo will be administered daily for up to 2 years after randomization or until they have minimal residual disease (MRD) negative disease, whichever comes first.\n\nDaily Glasdegib (100 mg, PO) or matching placebo will continue throughout Induction(s) and Consolidation therapies regardless of dose modifications/delays in the chemotherapy.|Consolidation with single agent cytarabine 3 g/m2 IV for adults <60 years and 1 g/m2 for adults 60 years over 3 BID on Days 1, 3, and 5, every 28 days for up to 4 cycles or alternative single agent cytarabine consolidation schedules may be used per local prescribing information.|If required, and done per standard of care post Induction(s).|Azacitidine (75 mg/m2, SC or IV) daily for 7 days, in 28 day cycles for as long as they do not meet the criteria for disease progression, unacceptable toxicity, consent withdrawal, or death.|Matching placebo (PO) is to be administered by mouth daily beginning on Day 1 of chemotherapy and will continue if subjects demonstrate reasonable evidence of clinical benefit and do not meet the criteria for progression regardless of any delays/modifications in the chemotherapy treatment. Subjects will continue placebo until disease progression, unacceptable toxicity, consent withdrawal, or death, whichever comes first.","PF-04449913","Arm A (Intensive Study)|Arm B (Intensive Study)|Arm A (Non-intensive study)|Arm B (Non-intensive study)","\n\nSubjects must meet all of the following inclusion criteria to be eligible for enrollment into the Intensive and Non Intensive study (unless where indicated):\n\n 1.  Subjects with untreated AML according to the World Health Organization (WHO) 2016 Classification2, including those with: * AML arising from MDS or another antecedent hematologic disease (AHD).\n      * AML after previous cytotoxic therapy or radiation (secondary AML).\n     \n     \n 2.  18 years of age (In Japan, 20 years of age).\n 3.  Adequate Organ Function as defined by the following: * Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) 3 x upper limit of normal (ULN), excluding subjects with liver function abnormalities due to underlying malignancy.\n      * Total serum bilirubin 2 x ULN (except subjects with documented Gilbert's syndrome).\n      * Estimated creatinine clearance 30 mL/min as calculated using the standard method for the institution.\n     \n     \n 4.  QTc interval 470 msec using the Fridericia correction (QTcF).\n 5.  All anti cancer treatments (unless specified) should be discontinued 2 weeks from study entry, for example: targeted chemotherapy, radiotherapy, investigational agents, hormones, anagrelide or cytokines. * For control of rapidly progressing leukemia, all trans retinoic acid (ATRA), hydroxyurea, and/or leukopheresis may be used before and for up to 1 week after the first dose of glasdegib.\n     \n     \n 6.  Serum or urine pregnancy test (for female subjects of childbearing potential) with a minimum sensitivity of 25 IU/L or equivalent units of human chorionic gonadotropin (hCG) negative at screening.\n 7.  Male and female subjects of childbearing potential and at risk for pregnancy must agree to use at least one highly effective method of contraception throughout the study and for 180 days after the last dose of azacitidine, cytarabine, or daunorubicin; and the last dose of glasdegib or placebo, whichever occurs later.\n 8.  Female subjects of non childbearing potential must meet at least 1 of the following criteria: 1. Have undergone a documented hysterectomy and/or bilateral oophorectomy;\n      2. Have medically confirmed ovarian failure; or\n      3. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; status may be confirmed by having a serum follicle stimulating hormone (FSH) level confirming the postmenopausal state.\n     \n     All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential.\n     \n     \n 9.  Consent to a saliva sample collection for a germline comparator, unless prohibited by local regulations or ethics committee (EC) decision.\n 10. Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.\n 11. Subjects who are willing and able to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures (including bone marrow [BM] assessments).\n\n","\n\nSubjects with any of the following characteristics/conditions will not be included in the study:\n\n 1.  Acute Promyelocytic Leukemia (APL) and APLwith PML RARA, subjects (WHO 2016 classification).\n 2.  AML with BCR ABL1 or t(9;22)(q34;q11.2) as a sole abnormality. * Complex genetics may include t(9;22) cytogenetic translocation.\n     \n     \n 3.  Subjects with known active CNS leukemia.\n 4.  Participation in other clinical studies involving other investigational drug(s) (Phases 1 4) within 4 weeks prior study entry and/or during study participation.\n 5.  Subjects known to be refractory to platelet or packed red cell transfusions per Institutional Guidelines, or a patient who refuses blood product support.\n 6.  Subjects with another active malignancy on treatment with the exception of basal cell carcinoma, non melanoma skin cancer, cervical carcinoma in situ. Other prior or concurrent malignancies will be considered on a case by case basis.\n 7.  Any one of the following ongoing or in the previous 6 months: myocardial infarction, congenital long QT syndrome, Torsades de pointes, symptomatic arrhythmias (including sustained ventricular tachyarrhythmia), right or left bundle branch block and bifascicular block, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (CHF New York Heart Association class III or IV), cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism; as well as bradycardia defined as <50 bpms.\n 8.  Subjects with an active, life threatening or clinically significant uncontrolled systemic infection not related to AML.\n 9.  Subjects with left ventricular ejection fraction (LVEF) <50% are excluded from the Intensive Chemotherapy Study only.\n 10. Cumulative anthracycline dose equivalent of 550 mg/m2 of daunorubicin for the Intensive Chemotherapy Study only.\n 11. Known malabsorption syndrome or other condition that may significantly impair absorption of study medication in the investigator's judgment (eg, gastrectomy, lap band, Crohn's disease) and inability or unwillingness to swallow tablets or capsules.\n 12. Current use or anticipated requirement for drugs that are known strong CYP3A4/5 inducers.\n 13. Concurrent administration of herbal preparations.\n 14. Major surgery or radiation within 4 weeks of starting study treatment.\n 15. Documented or suspected hypersensitivity to any one of the following: * For subjects assigned to intensive chemotherapy, documented or suspected hypersensitivity to cytarabine (not including drug fever or exanthema, including known cerebellar side effects) or daunorubicin.\n      * For subjects assigned to non intensive chemotherapy, documented or suspected hypersensitivity to azacitidine or mannitol.\n     \n     \n 16. Known active drug or alcohol abuse.\n 17. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.\n 18. Pregnant females or breastfeeding female subjects.\n 19. Known recent or active suicidal ideation or behavior.\n 20. Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.","FSH",null,"Protein","Ovary","Actual","2018-01-31","Actual","Anticipated","2025-07-22","Anticipated","2019-09-01","2017-12-21","2018-01-23","2019-09-09","Yes","glasdegib;\nuntreated;\nHedgehog Inhibitor","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"All",null,"No","Yes\nPfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",null,"URL: https://pmiform.com/clinical-trial-info-request?StudyID=B1371019 [https://pmiform.com/clinical-trial-info-request?StudyID=B1371019] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To obtain contact information for a study center near you, click here.",null,"Yes","No",{"$nulls":17},"2017-002822-19|BRIGHT|BRIGHT AML1019","EudraCT Number|Alias Study Number","Overall survival","5 years after last subject randomized",null,"Fatigue score measured by the MD Anderson Symptom Inventory (MDASI)-AML/MDS questionnaire|Rate of Complete Remission (CR) (including CR with minimal residual disease (MRD)-negative as assessed by multiparametric flow cytometry)|Duration of response (defined as CR [includes CR-MRD negative]/CRi or CR/CRh as appropriate)|Time to response (CR[includes CR-MRD negative)]/CR with partial hematologic rcovery (CRh) as appropriate)|Event-free Survival|Patient Reported Outcomes (PROs) as measured by the M.D. Anderson Symptom Inventory AML/MDS Module (MDASI-AML/MDS)|Adverse events as graded by NCI CTCAE v4.03|Laboratory abnormalities as graded by NCI CTCAE v4.03|For the intensive study, the plasma trough concentration (Ctrough) will be analyzed|QTc interval|PROs as measured by Patient Global Impression of Change (PGIC)|Patient Reported Outcomes (PROs) as measured by EuroQoL 5 Dimension questionnaire 5-Level version (EQ-5D-5L)|Patient Reported Outcomes (PROs) as measured by Patient Global Impression of Symptoms (PGIS)|Complete Remission with incomplete hematologic recovery (CRi)|Rate of morphological leukemia-free state (MLFS)|Rate of Partial Remission (PR)|Rate of Complete Remission with partial hematological recovery (CRh) for the Non-intensive study only only|Minimum Observed Plasma Trough Concentratrion of glasdegib in the Intensive Study|Minimum Observed Plasma Trough Concentration of glasdegib in the Non-intensive study","Scale is from 0-10 where 0 is not present and 10 is as bad as you can image.|Response as defined by the 2017 European LeukemiaNet (ELN) recommendations.|5 years after last subject randomized, consent withdrawal, or death|Measurement Scale from 0-10.|PK samples taken on Induction(s) Day 1 (1 and 4 hours post induction); Induction(s) Day 10 (pre-dose, 1 and 4 hours post dose); Day 1 of each Consolidation cycle (pre-dose, 1 and 4 hours post dose)|One question asking for description of leukemia symptoms.|Series of questions that ask for information that best describes health.|One question asking for information regarding leukemia symptoms.|Its the minimum trough concentration in plasma of glasdegib following multiple daily dosing to steady state.|It is the minimum trough concentration in plasma of glasdegib following multiple daily dosing to steady state.","5 years after last subject randomized, consent withdrawal, or death|2 years after last dose of study therapy|5 years after last patient randomized, withdrawal, or death|5 years after last subject randomized, withdrawal, or death|Day 10 of Induction Cycle and Day 1 of each Consolidation Cycle|Cycle 1 Day 15 and Cycles 2 and 3 on Day 1","ClinicalTrials.gov_Inquiries@pfizer.com","Pfizer CT.gov Call Center","1-800-718-1021","Adelaide, South|Darlinghurst, New South Wales, Australia, 2010 St George HospitalKogarah, New South Wales, Australia, 2217|Wels, Upper|Salzburg, Austria, 5020 Uniklinikum Salzburg, Landeskrankenhaus SalzburgSalzburg, Austria, 5020 Klinikum Wels-Grieskirchen GmbhWels, Austria, 4600 Sozialmedizinisches Zentrum Sud.Wien, Austria, 1100 Krankenhaus Hietzing Mit Neurologischem Zentrum RosenhugelWien, Austria, 1130|Brugge, Belgium, B-8000 Az Sint-Jan Brugge-Oostende AvBrugge, Belgium, B-8000 Universitaire Ziekenhuizen Brussel (Uz Brussel)Brussels, Belgium, B-1090 Universitaire Ziekenhuizen BrusselBrussels, Belgium, B-1090 Universitaire Ziekenhuizen LeuvenLeuven, Belgium, B-3000|Winnipeg, Manitoba, Canada, R3A 1R9 Cancercare ManitobaWinnipeg, Manitoba, Canada, R3E 0V9|Toronto, Ontario, Canada, M4N 3M5 Princess Margaret Cancer CentreToronto, Ontario, Canada, M5G 2M9|Montreal, Quebec, Canada, H1T 2M4|Fuzhou, Fujian, China, 350001|Guangzhou, Guangdong, China, 510080 Guangdong Second Provincial General HospitalGuangzhou, Guangdong, China, 510317|Zhengzhou, Henan, China, 450008|Chengdu, Sichuan, China, 610041|Wuhan, Hubei, China, 430030|Nanjing, Jiangsu, China, 210029|Shanghai, China, 200025|Qingdao, Shandong, China, 266071|Shanghai, Shanghai, China, 200080|Tianjin, Tianjin, China, 300020|Hangzhou, Zhejiang, China, 310003|Brno, Czechia, 100 34 Nemocnicni LekarnaBrno, Czechia, 625 00 Ustavni LekarnaOstrava - Poruba, Czechia, 708 52 Klinika HematoonkologieOstrava-Poruba, Czechia, 708 52 InternÃ­ HematologickÃ¡ Klinika, Fakultni Nemocnice KrÃ¡lovskÃ© VinohradyPraha 10, Czechia, 100 34 Ãšstavni LÃ©kÃ¡rnaPraha 10, Czechia, 100 34|Creteil, France, 94010 Chu Henri MondorCrÃ©teil, France, 94010 Chu De NantesNantes Cedex 1, France, 44093 Chu De Nantes Hotel DieuNantes Cedex, France, 44093 Hopital Saint LouisParis, France, 75010 Centre Hospitalier Lyon Sud - Service D'HematologiePierre Benite Cedex, France, 69495 Centre Hospitalier Lyon Sud -Unite De Pharmacie Clinique OncologiquePierre Benite Cedex, France, 69495 Institut Gustave RoussyVillejuif Cedex, France, 94805|Hannover, Germany, 30625 UniversitÃ¤tsklinikum KÃ¶lnKoeln, Germany, 50937 Philipps-Universitaet MarburgMarburg, Germany, 35032|Koeln, North Rhine Westphalia, Germany, 50937|Muenster, North-Rhine-Westphalia, Germany, 48149|Debrecen, Hungary, 4032 Debreceni Egyetem Klinikai Kozpont Belgyogyaszati KlinikaDebrecen, Hungary, 4032 Petz AladÃ¡r Megyei OktatÃ³ KÃ³rhÃ¡z, GyÃ³gyszerÃ©szeti OsztÃ¡lyGyÅ‘r, Hungary, 9024 Petz AladÃ¡r Megyei OktatÃ³ KÃ³rhÃ¡z, Ii. BelgyÃ³gyÃ¡szat- HematolÃ³giai OsztÃ¡lyGyÅ‘r, Hungary, 9024 Somogy Megyei Kaposi Mor Oktato KorhazKaposvar, Hungary, 7400 Szabolcs-Szatmar Bereg Megyei Korhazak Es Egyetemi Oktatokorhaz, Josa Andras Korhaz, HematologiaNyiregyhaza, Hungary, 4400 Szabolcs-Szatmar Bereg Megyei Korhazak Es Egyetemi Oktatokorhaz, Josa Andras Korhaz,Nyiregyhaza, Hungary, 4400|Boston, Massachusetts, United States, 02215|Haifa, Israel, 3109601 Shaare Zedek Medical CenterJerusalem, Israel, 9103102 Hadassah Medical Center (Ein Kerem)Jerusalem, Israel, 91120 Hemato-Oncology Ambulatory ServicePetah Tikva, Israel, 4941492 Hematology Division - Oncology PharmacyPetah Tikva, Israel, 4941492 Rabin Medical Center, Beilinson HospitalPetah Tikva, Israel, 4941492 Tel-Aviv Sourasky Medical CenterTel Aviv, Israel, 6423906|Torette Di Ancona, An, Italy, 60126|Torrette Di Ancona, Ancona, Italy, 60126|Bologna, Italy, 40138|Meldola, Fc, Italy, 47014|Cona, Ferrara, Fe, Italy, 44124 Farmacia OspedalieraFerrara, Fe, Italy, 44121|Pesaro, Pu, Italy, 61122|Roma, Rm, Italy, 00161|Siena, Si, Italy, 53100|Nagoya, Aichi, Japan, 466-8650|Akita, Japan, 010-8543 Kyushu University HospitalFukuoka, Japan, 812-8582 National Hospital Organization Kumamoto Medical Center[Active, Not Recruiting]Kumamoto, Japan, 860-0008 Nagasaki University HospitalNagasaki, Japan, 852-8501 Tokyo Medical University HospitalTokyo, Japan, 160-0023 Korea, Republic Of, Jeollabuk-Do Chonbuk National University HospitalJeonju-Si, Jeollabuk-Do, Korea, Republic Of, 54907 Korea, Republic Of, Jeollanam-Do Chonnam National University Hwasun HospitalHwasun-Gun, Jeollanam-Do, Korea, Republic Of, 58128 Korea, Republic Of Department Of Pharmacy, Inje University Busan Paik HospitalBusan, Korea, Republic Of, 47392 Inje University Busan Paik HospitalBusan, Korea, Republic Of, 47392 Clinical Trial Pharmacy, Keimyung University Dongsan HospitalDaegu, Korea, Republic Of, 42601 Keimyung University Dongsan HospitalDaegu, Korea, Republic Of, 42601 Gachon University Gil Medical CenterIncheon, Korea, Republic Of, 21565 Seoul National University HospitalSeoul, Korea, Republic Of, 03080 Clinical Trial Center, Severance Hospital, Yonsei University Health SystemSeoul, Korea, Republic Of, 03722 Severance Hospital, Yonsei University Health SystemSeoul, Korea, Republic Of, 03722 Department Of Pharmacy, Samsung Medical CenterSeoul, Korea, Republic Of, 06351 Samsung Medical CenterSeoul, Korea, Republic Of, 06351 Department Of Pharmacy, Severance Hospital, Yonsei University Health SystemSeoul, Korea, Republic Of, 06591 The Catholic University Of Korea Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591 The Catholic University Of Korea, Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591|Yoshida-Gun, Fukui, Japan, 910-1193|Maebashi, Gunma, Japan, 371-8511|Kobe-Shi, Hyogo, Japan, 650-0017|Yokohama, Kanagawa, Japan, 232-0024|Sendai, Miyagi, Japan, 980-8574|Osaka-City, Osaka, Japan, 545-8586 Kindai University HospitalOsaka-Sayama, Osaka, Japan, 589-8511|Sunto-Gun, Shizuoka, Japan, 411-8777|Tachikawa, Tokyo, Japan, 190-0014|MÃ©xico, Mexico, 06726|MÃ©xico, MÃ©x, Mexico, 14080|Gdansk, Poland, 80-214 Wwcoit Im. M. Kopernika W LodziLodz, Poland, 93-513|Cluj-Napoca, Cluj, Romania, 400124|Craiova, Dolj, Romania, 200136|Bucuresti, Romania, 010825 Spitalul Clinic Coltea, Clinica De HematologieBucuresti, Romania, 030171 Russian Federation Sbhi Cch No. 40 Hd MoscowMoscow, Russian Federation, 129301 State Budgetary Healthcare Institution Of MoscowMoscow, Russian Federation, 129301 Sbhi Nnr Nn Rch N. A. N.A. SemashkoNizhniy Novgorod, Russian Federation, 603126 State Budgetary Institution Of Ryazan Region 'Regional Clinical Hospital' (Sbi Rr Rch)Ryazan, Russian Federation, 390039 Fsbi Russrhti Fmba Of|Barcelona, Spain, 08003 Hospital De La Santa Creu I Sant PauBarcelona, Spain, 08025 Hospital Universitario Arnau De VilanovaLleida, Spain, 25198 Hospital General Universitario Gregorio MaranonMadrid, Spain, 28007 Hospital Universitario Ramon Y CajalMadrid, Spain, 28034 Hospital Universitario Virgen Del RocioSevilla, Spain, 41013 Hospital Universitari I Politecnic La FeValencia, Spain, 46026|Goteborg, Sweden, 413 45 Apl, Apl Sahlgrenska, Kliniska ProvningarGoteborg, Sweden, 413 46 Apoex VnOrebro, Sweden, 701 85 Universitetssjukhuset OrebroOrebro, Sweden, 701 85 Karolinska Universitetssjukhuset HuddingeStockholm, Sweden, 141 86 Taiwan National Cheng Kung University HospitalTainan, Taiwan, 704 National Taiwan University HospitalTaipei, Taiwan, 100 Department Of Clinical Trial Pharmacy, Taipei Veterans General HospitalTaipei, Taiwan, 11217 Taipei Veterans General HospitalTaipei, Taiwan, 11217 Division Of Pharmacy, Koo Foundation Sun Yat-Sen Cancer CenterTaipei, Taiwan, 112 Koo Foundation Sun Yat-Sen Cancer CenterTaipei, Taiwan, 112 Chang Gung Memorial Hospital-Linkou BranchTaoyuan City, Taiwan, 333 Chemotherapy Pharmacy, Chang Gung Memorial Hospital-Linkou BranchTaoyuan City, Taiwan, 333|Sutton, Surrey, United Kingdom, Sm2 5Pt|Birmingham, West Midlands, United Kingdom, B15 2Th University Hospitals Birmingham Nhs Foundation TrustBirmingham, West Midlands, United Kingdom, B30 3Hg|London, United Kingdom, Ec1A 7Be Imperial College Healthcare Nhs TrustLondon, United Kingdom, W12 0Hs|Los Angeles, California, United States, 90033 Lac+Usc Medical CenterLos Angeles, California, United States, 90033 Usc/Norris Comprehensive Cancer Center / Investigational Drug ServicesLos Angeles, California, United States, 90033 Usc/Norris Comprehensive Cancer CenterLos Angeles, California, United States, 90033 Rrmc - UclaLos Angeles, California, United States, 90095 Ucla Department Of MedicineLos Angeles, California, United States, 90095 Ucla Hematology/Oncology ClinicLos Angeles, California, United States, 90095 Ucla Ronald Reagan Medical CenterLos Angeles, California, United States, 90095 Keck Medicine Of Usc Norris Oncology/Hematology - Newport Beach Treatment CenterNewport Beach, California, United States, 92663 Usc Norris Oncology/Hematology - Newport BeachNewport Beach, California, United States, 92663 Uc Irvine Health - Chao Family Comprehensive Cancer CenterOrange, California, United States, 92868-3201 Uc Irvine Medical CenterOrange, California, United States, 92868-3201 Ucsf Helen Diller Family Comprehensive Cancer CenterSan Francisco, California, United States, 94143 University Of California, San Francisco Medical CenterSan Francisco, California, United States, 94143 University Of California, San FranciscoSan Francisco, California, United States, 94143|Boston, Massachusetts, United States, 02111 Tufts Medical CenterBoston, Massachusetts, United States, 02111 Massachusetts General HospitalBoston, Massachusetts, United States, 02114 Beth|Kansas City, Missouri, United States, 64132|Lake Success, New York, United States, 11042 North Shore University HospitalManhasset, New York, United States, 11030 Long Island Jewish Medical CenterNew Hyde Park, New York, United States, 11040 University Of Rochester Cancer Center PharmacyRochester, New York, United States, 14642 University Of Rochester Medical CenterRochester, New York, United States, 14642|Cleveland, Ohio, United States, 44106 University Hospitals Cleveland Medical CenterCleveland, Ohio, United States, 44106 Cleveland Clinic FoundationCleveland, Ohio, United States, 44195|Portland, Oregon, United States, 97239 Oregon Health & Science University-Research Pharmacy ServicesPortland, Oregon, United States, 97239 Oregon Health & Science UniversityPortland, Oregon, United States, 97239|Nashville, Tennessee, United States, 37203 The Sarah Cannon Research InstituteNashville, Tennessee, United States, 37203|Dallas, Texas, United States, 75246 Baylor University Medical CenterDallas, Texas, United States, 75246 The University Of Texas, Md Anderson Cancer CenterHouston, Texas, United States, 77030 Blood Cancer And Stem Cell Transplant ClinicSan Antonio, Texas, United States, 78229 Methodist Healthcare System Of San AntonioSan Antonio, Texas, United States, 78229 Methodist Hospital Investigational PharmacySan Antonio, Texas, United States, 78229|Seattle, Washington, United States, 98104 Swedish First Hill Ids PharmacySeattle, Washington, United States, 98104 Swedish Medical CenterSeattle, Washington, United States, 98122","California|Massachusetts|Missouri|New York|Ohio|Oregon|Tennessee|Texas|Washington","Australia|Austria|Belgium|Canada|China|Czechia|France|Germany|Hungary|Israel|Italy|Japan|Mexico|Poland|Romania|Spain|Sweden|United Kingdom|United States","Australia, 5000 Royal Adelaide Hospital|New South Wales St Vincent's Hospital Sydney|Royal Adelaide Hospital - Clinical Trials Pharmacy|Klinikum Wels-Grieskirchen Gmbh|Landeskrankenhaus Salzburg, Universitatsklinik Fur Innere Medizin Iii Der Pmu|Az Sint-Jan Brugge - Oostende Av|Manitoba Health Sciences Centre|Ontario Sunnybrook Research Institute|Quebec Ciusss De L'Est-De-L'Ile-De- MontrÃ©al - HÃ´pital Maisonneuve-Rosemont|Fujian Fujian Medical University Union Hospital|Guangdong Guangdong Provincial People's Hospital|Henan Henan Cancer Hostipal|Hospital, Sichuan University|Hubei Tongji Hospital, Tongji Medical College, Huazhong University Of Science & Technology/Cancer Center|Jiangsu Jiangsu Province Hospital|Ruijin Hospital Affiliated To Shanghai Jiaotong University School Of Medicine|Shandong Affiliated Hospital Of Qingdao University/Hematology Department|Shanghai Shanghai General Hospital|Tianjin Institute Of Hematology And Blood Diseases Hospital, Chinese Academy Of Medical Sciences|Zhejiang The First Affiliated Hospital College Of Medicine, Zhejiang University|Interni Hematologicka A Onkologicka Klinika, Fakultni Nemocnice Brno|Chu Henri Mondor|Medizinische Hochschule Hannover|North Rhine Westphalia UniversitÃ¤tsklinikum KÃ¶ln|North-Rhine-Westphalia Universitaetsklinikum Muenster|Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Klinika, Hematologia Tanszek|Deaconess Medical Center|Rambam Health Care Campus|An Sod Farmacia-Dipt Dei Servizi -Aou Ospedali Riuniti Umberto I, G.M. Lancisi, G. Salesi|Ancona Aou Ospedali Riuniti Umberto I, G.M. Lancisi, G. Salesi, Clinica Di Ematologia|Azienda Ospedaliero Universitaria Di Bologna Policlinico S.Orsola Malpighi|Fc Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori|Fe A.O.U. Di Ferrara- Arcispedale Sant'Anna,|Pu Ao Ospedali Riuniti Marche Nord - Presidio Ospedaliero San Salvatore Di Pesaro -|Rm Azienda Ospedaliero Universitaria Policlinico Umberto I|Si Azienda Ospedaliera Universitaria Senese.|Aichi Japanese Red Cross Nagoya Daini Hospital|Akita University Hospital|Fukui University Of Fukui Hospital|Gunma Gunma University Hospital|Hyogo Kobe University Hospital|Kanagawa Yokohama City University Medical Center|Miyagi Tohoku University Hospital|Osaka Osaka City University Hospital|Shizuoka Shizuoka Cancer Center|Tokyo National Hospital Organization Disaster Medical Center|Hospital General De MÃ©xico Dr. Eduardo Liceaga|MÃ©x Instituto Nacional De CancerologÃ­a|Klinika Hematologii I Transplantologii Uniwersyteckie Centrum Kliniczne|Cluj Institutul Oncologic 'Prof. Dr. Ion Chiricuta'|Dolj Spitalul Clinic Municipal Filantropia Craiova, Sectia Clinica Hematologie|Spitalul Universitar De Urgenta Militar Central \"Dr. Carol Davila\" Bucuresti|Hospital Del Mar|Sektionen For Hematologi Och Koagulation|, Surrey The Royal Marsden Nhs Foundation Trust|, West Midlands University Hospitals Birmingham Nhs Foundation Trust|Barts Health Nhs Trust|Keck Hospital Of Usc|Tufts Medical Center Investigational Pharmacy|Midamerica Division, Inc., C/O Research Medical Center|Northwell Health/Monter Cancer Center|Taussig Cancer Center Investigational Pharmacy|Ohsu Center For Health And Healing|Centennial Medical Center|Baylor Scott And White Research Institute|Swedish Cancer Institute",{"$nulls":3},"Pfizer CT.gov Call Center","2019-09-09","2020-05-25T16:39:38.900","2020-05-26T17:10:42.972","NCT03416179"]
["5ecbf4ca11702c1b1b916bcf","NCT03416179","2019-09-24","Pfizer","PFE","Recruiting","A Study Evaluating Intensive Chemotherapy With or Without Glasdegib or Azacitidine With or Without Glasdegib In Patients With Previously Untreated Acute Myeloid Leukemia (BRIGHT AML1019)","Glasdegib|Cytarabine|Daunorubicin|Azacitidine","Hh Inhibitor|DNA Polymerase Inhibitor|Nucleic Acid Synthesis Inhibitor|TOP2 Inhibitor|DNA Mtase Inhibitor","Unknown",null,"Unknown",null,"Phase 3",4,720,"Anticipated","2018-04-20","2021-06-13","OS","Overall Survival",{"$nulls":3},"Glasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).\n\nGlasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).","Two separate registration trials conducted under one protocol number are proposed to adequately and independently evaluate the addition of glasdegib in intensive and non-intensive chemotherapy populations. Each study will have an experimental treatment arm and a placebo arm. Endpoints are the same for each study except where specifically indicated.\n\nAssignment to the Intensive Study or the Non-Intensive Study will be made by the Investigator based on the 2017 European LeukemiaNet (ELN) recommendations.\n\nStudy B1371019 is a randomized (1:1), double-blind, multi-center, placebo controlled study of chemotherapy in combination with glasdegib versus chemotherapy in combination with placebo in adult patients with previously untreated AML.\n\nGlasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).\n\nGlasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).","A RANDOMIZED (1:1), DOUBLE-BLIND, MULTI-CENTER, PLACEBO CONTROLLED STUDY EVALUATING INTENSIVE CHEMOTHERAPY WITH OR WITHOUT GLASDEGIB (PF-04449913) OR AZACITIDINE (AZA) WITH OR WITHOUT GLASDEGIB IN PATIENTS WITH PREVIOUSLY UNTREATED ACUTE MYELOID LEUKEMIA","B1371019","Leukemia, Myeloid, Acute","Acute Leukemia|Acute Myeloid Leukemia|Myeloid Leukemia|Leukemia","Oncology Hematological","Oncology","Experimental|Placebo Comparator","Arm A (Intensive Study)|Arm B (Intensive Study)|Arm A (Non-intensive study)|Arm B (Non-intensive study)","Glasdegib + '7+3' Induction(s)|Placebo + '7+3' Induction(s)|Glasdegib + azacitidine|Placebo + azacitidine","Drug|Procedure","glasdegib|daunorubicin + cytarabine|cytarabine|HSCT|Placebo|azacitidine","Daily Glasdegib (100 mg, PO), beginning on Day 1 and is to continue up to 2 years post randomization.\n\nFollowing consolidation therapy, glasdegib or placebo will be administered daily for up to 2 years after randomization or until they have minimal residual disease (MRD) negative disease, whichever comes first.\n\nDaily Glasdegib (100 mg, PO) or matching placebo will continue throughout Induction(s) and Consolidation therapies regardless of dose modifications/delays in the chemotherapy.|Consolidation with single agent cytarabine 3 g/m2 IV for adults <60 years and 1 g/m2 for adults 60 years over 3 BID on Days 1, 3, and 5, every 28 days for up to 4 cycles or alternative single agent cytarabine consolidation schedules may be used per local prescribing information.|If required, and done per standard of care post Induction(s).|Azacitidine (75 mg/m2, SC or IV) daily for 7 days, in 28 day cycles for as long as they do not meet the criteria for disease progression, unacceptable toxicity, consent withdrawal, or death.|Matching placebo (PO) is to be administered by mouth daily beginning on Day 1 of chemotherapy and will continue if subjects demonstrate reasonable evidence of clinical benefit and do not meet the criteria for progression regardless of any delays/modifications in the chemotherapy treatment. Subjects will continue placebo until disease progression, unacceptable toxicity, consent withdrawal, or death, whichever comes first.","PF-04449913","Arm A (Intensive Study)|Arm B (Intensive Study)|Arm A (Non-intensive study)|Arm B (Non-intensive study)","\n\nSubjects must meet all of the following inclusion criteria to be eligible for enrollment into the Intensive and Non Intensive study (unless where indicated):\n\n 1.  Subjects with untreated AML according to the World Health Organization (WHO) 2016 Classification2, including those with: * AML arising from MDS or another antecedent hematologic disease (AHD).\n      * AML after previous cytotoxic therapy or radiation (secondary AML).\n     \n     \n 2.  18 years of age (In Japan, 20 years of age).\n 3.  Adequate Organ Function as defined by the following: * Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) 3 x upper limit of normal (ULN), excluding subjects with liver function abnormalities due to underlying malignancy.\n      * Total serum bilirubin 2 x ULN (except subjects with documented Gilbert's syndrome).\n      * Estimated creatinine clearance 30 mL/min as calculated using the standard method for the institution.\n     \n     \n 4.  QTc interval 470 msec using the Fridericia correction (QTcF).\n 5.  All anti cancer treatments (unless specified) should be discontinued 2 weeks from study entry, for example: targeted chemotherapy, radiotherapy, investigational agents, hormones, anagrelide or cytokines. * For control of rapidly progressing leukemia, all trans retinoic acid (ATRA), hydroxyurea, and/or leukopheresis may be used before and for up to 1 week after the first dose of glasdegib.\n     \n     \n 6.  Serum or urine pregnancy test (for female subjects of childbearing potential) with a minimum sensitivity of 25 IU/L or equivalent units of human chorionic gonadotropin (hCG) negative at screening.\n 7.  Male and female subjects of childbearing potential and at risk for pregnancy must agree to use at least one highly effective method of contraception throughout the study and for 180 days after the last dose of azacitidine, cytarabine, or daunorubicin; and the last dose of glasdegib or placebo, whichever occurs later.\n 8.  Female subjects of non childbearing potential must meet at least 1 of the following criteria: 1. Have undergone a documented hysterectomy and/or bilateral oophorectomy;\n      2. Have medically confirmed ovarian failure; or\n      3. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; status may be confirmed by having a serum follicle stimulating hormone (FSH) level confirming the postmenopausal state.\n     \n     All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential.\n     \n     \n 9.  Consent to a saliva sample collection for a germline comparator, unless prohibited by local regulations or ethics committee (EC) decision.\n 10. Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.\n 11. Subjects who are willing and able to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures (including bone marrow [BM] assessments).\n\n","\n\nSubjects with any of the following characteristics/conditions will not be included in the study:\n\n 1.  Acute Promyelocytic Leukemia (APL) and APLwith PML RARA, subjects (WHO 2016 classification).\n 2.  AML with BCR ABL1 or t(9;22)(q34;q11.2) as a sole abnormality. * Complex genetics may include t(9;22) cytogenetic translocation.\n     \n     \n 3.  Subjects with known active CNS leukemia.\n 4.  Participation in other clinical studies involving other investigational drug(s) (Phases 1 4) within 4 weeks prior study entry and/or during study participation.\n 5.  Subjects known to be refractory to platelet or packed red cell transfusions per Institutional Guidelines, or a patient who refuses blood product support.\n 6.  Subjects with another active malignancy on treatment with the exception of basal cell carcinoma, non melanoma skin cancer, cervical carcinoma in situ. Other prior or concurrent malignancies will be considered on a case by case basis.\n 7.  Any one of the following ongoing or in the previous 6 months: myocardial infarction, congenital long QT syndrome, Torsades de pointes, symptomatic arrhythmias (including sustained ventricular tachyarrhythmia), right or left bundle branch block and bifascicular block, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (CHF New York Heart Association class III or IV), cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism; as well as bradycardia defined as <50 bpms.\n 8.  Subjects with an active, life threatening or clinically significant uncontrolled systemic infection not related to AML.\n 9.  Subjects with left ventricular ejection fraction (LVEF) <50% are excluded from the Intensive Chemotherapy Study only.\n 10. Cumulative anthracycline dose equivalent of 550 mg/m2 of daunorubicin for the Intensive Chemotherapy Study only.\n 11. Known malabsorption syndrome or other condition that may significantly impair absorption of study medication in the investigator's judgment (eg, gastrectomy, lap band, Crohn's disease) and inability or unwillingness to swallow tablets or capsules.\n 12. Current use or anticipated requirement for drugs that are known strong CYP3A4/5 inducers.\n 13. Concurrent administration of herbal preparations.\n 14. Major surgery or radiation within 4 weeks of starting study treatment.\n 15. Documented or suspected hypersensitivity to any one of the following: * For subjects assigned to intensive chemotherapy, documented or suspected hypersensitivity to cytarabine (not including drug fever or exanthema, including known cerebellar side effects) or daunorubicin.\n      * For subjects assigned to non intensive chemotherapy, documented or suspected hypersensitivity to azacitidine or mannitol.\n     \n     \n 16. Known active drug or alcohol abuse.\n 17. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.\n 18. Pregnant females or breastfeeding female subjects.\n 19. Known recent or active suicidal ideation or behavior.\n 20. Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.","FSH",null,"Protein","Ovary","Actual","2018-01-31","Actual","Anticipated","2025-07-22","Anticipated","2019-09-01","2017-12-21","2018-01-23","2019-09-21","Yes","glasdegib;\nuntreated;\nHedgehog Inhibitor","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"All",null,"No","Yes\nPfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",null,"URL: https://pmiform.com/clinical-trial-info-request?StudyID=B1371019 [https://pmiform.com/clinical-trial-info-request?StudyID=B1371019] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To obtain contact information for a study center near you, click here.",null,"Yes","No",{"$nulls":17},"2017-002822-19|BRIGHT|BRIGHT AML1019","EudraCT Number|Alias Study Number","Overall survival","5 years after last subject randomized",null,"Fatigue score measured by the MD Anderson Symptom Inventory (MDASI)-AML/MDS questionnaire|Rate of Complete Remission (CR) (including CR with minimal residual disease (MRD)-negative as assessed by multiparametric flow cytometry)|Duration of response (defined as CR [includes CR-MRD negative]/CRi or CR/CRh as appropriate)|Time to response (CR[includes CR-MRD negative)]/CR with partial hematologic rcovery (CRh) as appropriate)|Event-free Survival|Patient Reported Outcomes (PROs) as measured by the M.D. Anderson Symptom Inventory AML/MDS Module (MDASI-AML/MDS)|Adverse events as graded by NCI CTCAE v4.03|Laboratory abnormalities as graded by NCI CTCAE v4.03|For the intensive study, the plasma trough concentration (Ctrough) will be analyzed|QTc interval|PROs as measured by Patient Global Impression of Change (PGIC)|Patient Reported Outcomes (PROs) as measured by EuroQoL 5 Dimension questionnaire 5-Level version (EQ-5D-5L)|Patient Reported Outcomes (PROs) as measured by Patient Global Impression of Symptoms (PGIS)|Complete Remission with incomplete hematologic recovery (CRi)|Rate of morphological leukemia-free state (MLFS)|Rate of Partial Remission (PR)|Rate of Complete Remission with partial hematological recovery (CRh) for the Non-intensive study only only|Minimum Observed Plasma Trough Concentratrion of glasdegib in the Intensive Study|Minimum Observed Plasma Trough Concentration of glasdegib in the Non-intensive study","Scale is from 0-10 where 0 is not present and 10 is as bad as you can image.|Response as defined by the 2017 European LeukemiaNet (ELN) recommendations.|5 years after last subject randomized, consent withdrawal, or death|Measurement Scale from 0-10.|PK samples taken on Induction(s) Day 1 (1 and 4 hours post induction); Induction(s) Day 10 (pre-dose, 1 and 4 hours post dose); Day 1 of each Consolidation cycle (pre-dose, 1 and 4 hours post dose)|One question asking for description of leukemia symptoms.|Series of questions that ask for information that best describes health.|One question asking for information regarding leukemia symptoms.|Its the minimum trough concentration in plasma of glasdegib following multiple daily dosing to steady state.|It is the minimum trough concentration in plasma of glasdegib following multiple daily dosing to steady state.","5 years after last subject randomized, consent withdrawal, or death|2 years after last dose of study therapy|5 years after last patient randomized, withdrawal, or death|5 years after last subject randomized, withdrawal, or death|Day 10 of Induction Cycle and Day 1 of each Consolidation Cycle|Cycle 1 Day 15 and Cycles 2 and 3 on Day 1","ClinicalTrials.gov_Inquiries@pfizer.com","Pfizer CT.gov Call Center","1-800-718-1021","Adelaide, South|Darlinghurst, New South Wales, Australia, 2010 St George HospitalKogarah, New South Wales, Australia, 2217|Wels, Upper|Salzburg, Austria, 5020 Uniklinikum Salzburg, Landeskrankenhaus SalzburgSalzburg, Austria, 5020 Klinikum Wels-Grieskirchen GmbhWels, Austria, 4600 Sozialmedizinisches Zentrum Sud.Wien, Austria, 1100 Krankenhaus Hietzing Mit Neurologischem Zentrum RosenhugelWien, Austria, 1130|Brugge, Belgium, B-8000 Az Sint-Jan Brugge-Oostende AvBrugge, Belgium, B-8000 Universitaire Ziekenhuizen Brussel (Uz Brussel)Brussels, Belgium, B-1090 Universitaire Ziekenhuizen BrusselBrussels, Belgium, B-1090 Universitaire Ziekenhuizen LeuvenLeuven, Belgium, B-3000|Winnipeg, Manitoba, Canada, R3A 1R9 Cancercare ManitobaWinnipeg, Manitoba, Canada, R3E 0V9|Toronto, Ontario, Canada, M4N 3M5 Princess Margaret Cancer CentreToronto, Ontario, Canada, M5G 2M9|Montreal, Quebec, Canada, H1T 2M4|Fuzhou, Fujian, China, 350001|Guangzhou, Guangdong, China, 510080 Guangdong Second Provincial General HospitalGuangzhou, Guangdong, China, 510317|Zhengzhou, Henan, China, 450008|Chengdu, Sichuan, China, 610041|Wuhan, Hubei, China, 430030|Nanjing, Jiangsu, China, 210029|Shanghai, China, 200025|Qingdao, Shandong, China, 266071|Shanghai, Shanghai, China, 200080|Tianjin, Tianjin, China, 300020|Hangzhou, Zhejiang, China, 310003|Brno, Czechia, 100 34 Nemocnicni LekarnaBrno, Czechia, 625 00 Ustavni LekarnaOstrava - Poruba, Czechia, 708 52 Klinika HematoonkologieOstrava-Poruba, Czechia, 708 52 InternÃ­ HematologickÃ¡ Klinika, Fakultni Nemocnice KrÃ¡lovskÃ© VinohradyPraha 10, Czechia, 100 34 Ãšstavni LÃ©kÃ¡rnaPraha 10, Czechia, 100 34|Creteil, France, 94010 Chu Henri MondorCrÃ©teil, France, 94010 Chu De NantesNantes Cedex 1, France, 44093 Chu De Nantes Hotel DieuNantes Cedex, France, 44093 Hopital Saint LouisParis, France, 75010 Centre Hospitalier Lyon Sud - Service D'HematologiePierre Benite Cedex, France, 69495 Centre Hospitalier Lyon Sud -Unite De Pharmacie Clinique OncologiquePierre Benite Cedex, France, 69495 Institut Gustave RoussyVillejuif Cedex, France, 94805|Hannover, Germany, 30625 UniversitÃ¤tsklinikum KÃ¶lnKoeln, Germany, 50937 Philipps-Universitaet MarburgMarburg, Germany, 35032|Koeln, North Rhine Westphalia, Germany, 50937|Muenster, North-Rhine-Westphalia, Germany, 48149|Debrecen, Hungary, 4032 Debreceni Egyetem Klinikai Kozpont Belgyogyaszati KlinikaDebrecen, Hungary, 4032 Petz AladÃ¡r Megyei OktatÃ³ KÃ³rhÃ¡z, GyÃ³gyszerÃ©szeti OsztÃ¡lyGyÅ‘r, Hungary, 9024 Petz AladÃ¡r Megyei OktatÃ³ KÃ³rhÃ¡z, Ii. BelgyÃ³gyÃ¡szat- HematolÃ³giai OsztÃ¡lyGyÅ‘r, Hungary, 9024 Somogy Megyei Kaposi Mor Oktato KorhazKaposvar, Hungary, 7400 Szabolcs-Szatmar Bereg Megyei Korhazak Es Egyetemi Oktatokorhaz, Josa Andras Korhaz, HematologiaNyiregyhaza, Hungary, 4400 Szabolcs-Szatmar Bereg Megyei Korhazak Es Egyetemi Oktatokorhaz, Josa Andras Korhaz,Nyiregyhaza, Hungary, 4400|Boston, Massachusetts, United States, 02215|Haifa, Israel, 3109601 Shaare Zedek Medical CenterJerusalem, Israel, 9103102 Hadassah Medical Center (Ein Kerem)Jerusalem, Israel, 91120 Hemato-Oncology Ambulatory ServicePetah Tikva, Israel, 4941492 Hematology Division - Oncology PharmacyPetah Tikva, Israel, 4941492 Rabin Medical Center, Beilinson HospitalPetah Tikva, Israel, 4941492 Tel-Aviv Sourasky Medical CenterTel Aviv, Israel, 6423906|Torette Di Ancona, An, Italy, 60126|Torrette Di Ancona, Ancona, Italy, 60126|Bologna, Italy, 40138 Azienda Ospedaliera Universitaria SeneseSiena, Italy, 53100|Meldola, Fc, Italy, 47014|Cona, Ferrara, Fe, Italy, 44124 Farmacia OspedalieraFerrara, Fe, Italy, 44121|Pesaro, Pu, Italy, 61122|Roma, Rm, Italy, 00161|Siena, Si, Italy, 53100|Nagoya, Aichi, Japan, 466-8650|Akita, Japan, 010-8543 Kyushu University HospitalFukuoka, Japan, 812-8582 National Hospital Organization Kumamoto Medical Center[Active, Not Recruiting]Kumamoto, Japan, 860-0008 Nagasaki University HospitalNagasaki, Japan, 852-8501 Tokyo Medical University HospitalTokyo, Japan, 160-0023 Korea, Republic Of, Jeollabuk-Do Chonbuk National University HospitalJeonju-Si, Jeollabuk-Do, Korea, Republic Of, 54907 Korea, Republic Of, Jeollanam-Do Chonnam National University Hwasun HospitalHwasun-Gun, Jeollanam-Do, Korea, Republic Of, 58128 Korea, Republic Of Department Of Pharmacy, Inje University Busan Paik HospitalBusan, Korea, Republic Of, 47392 Inje University Busan Paik HospitalBusan, Korea, Republic Of, 47392 Clinical Trial Pharmacy, Keimyung University Dongsan HospitalDaegu, Korea, Republic Of, 42601 Keimyung University Dongsan HospitalDaegu, Korea, Republic Of, 42601 Gachon University Gil Medical CenterIncheon, Korea, Republic Of, 21565 Seoul National University HospitalSeoul, Korea, Republic Of, 03080 Clinical Trial Center, Severance Hospital, Yonsei University Health SystemSeoul, Korea, Republic Of, 03722 Severance Hospital, Yonsei University Health SystemSeoul, Korea, Republic Of, 03722 Department Of Pharmacy, Samsung Medical CenterSeoul, Korea, Republic Of, 06351 Samsung Medical CenterSeoul, Korea, Republic Of, 06351 Department Of Pharmacy, Severance Hospital, Yonsei University Health SystemSeoul, Korea, Republic Of, 06591 The Catholic University Of Korea Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591 The Catholic University Of Korea, Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591|Yoshida-Gun, Fukui, Japan, 910-1193|Maebashi, Gunma, Japan, 371-8511|Kobe-Shi, Hyogo, Japan, 650-0017|Yokohama, Kanagawa, Japan, 232-0024|Sendai, Miyagi, Japan, 980-8574|Osaka-City, Osaka, Japan, 545-8586 Kindai University HospitalOsaka-Sayama, Osaka, Japan, 589-8511|Sunto-Gun, Shizuoka, Japan, 411-8777|Tachikawa, Tokyo, Japan, 190-0014|MÃ©xico, Mexico, 06726|MÃ©xico, MÃ©x, Mexico, 14080|Gdansk, Poland, 80-214 Wwcoit Im. M. Kopernika W LodziLodz, Poland, 93-513|Cluj-Napoca, Cluj, Romania, 400124|Craiova, Dolj, Romania, 200136|Bucuresti, Romania, 010825 Spitalul Clinic Coltea, Clinica De HematologieBucuresti, Romania, 030171 Russian Federation Sbhi Cch No. 40 Hd MoscowMoscow, Russian Federation, 129301 State Budgetary Healthcare Institution Of MoscowMoscow, Russian Federation, 129301 Sbhi Nnr Nn Rch N. A. N.A. SemashkoNizhniy Novgorod, Russian Federation, 603126 State Budgetary Institution Of Ryazan Region 'Regional Clinical Hospital' (Sbi Rr Rch)Ryazan, Russian Federation, 390039 Fsbi Russrhti Fmba Of|Barcelona, Spain, 08003 Hospital De La Santa Creu I Sant PauBarcelona, Spain, 08025 Hospital Universitario Arnau De VilanovaLleida, Spain, 25198 Hospital General Universitario Gregorio MaranonMadrid, Spain, 28007 Hospital Universitario Ramon Y CajalMadrid, Spain, 28034 Hospital Universitario Virgen Del RocioSevilla, Spain, 41013 Hospital Universitari I Politecnic La FeValencia, Spain, 46026|Goteborg, Sweden, 413 45 Apl, Apl Sahlgrenska, Kliniska ProvningarGoteborg, Sweden, 413 46 Apoex VnOrebro, Sweden, 701 85 Universitetssjukhuset OrebroOrebro, Sweden, 701 85 Karolinska Universitetssjukhuset HuddingeStockholm, Sweden, 141 86 Taiwan National Cheng Kung University HospitalTainan, Taiwan, 704 National Taiwan University HospitalTaipei, Taiwan, 100 Department Of Clinical Trial Pharmacy, Taipei Veterans General HospitalTaipei, Taiwan, 11217 Taipei Veterans General HospitalTaipei, Taiwan, 11217 Division Of Pharmacy, Koo Foundation Sun Yat-Sen Cancer CenterTaipei, Taiwan, 112 Koo Foundation Sun Yat-Sen Cancer CenterTaipei, Taiwan, 112 Chang Gung Memorial Hospital-Linkou BranchTaoyuan City, Taiwan, 333 Chemotherapy Pharmacy, Chang Gung Memorial Hospital-Linkou BranchTaoyuan City, Taiwan, 333|Sutton, Surrey, United Kingdom, Sm2 5Pt|Birmingham, West Midlands, United Kingdom, B15 2Th University Hospitals Birmingham Nhs Foundation TrustBirmingham, West Midlands, United Kingdom, B30 3Hg|London, United Kingdom, Ec1A 7Be Imperial College Healthcare Nhs TrustLondon, United Kingdom, W12 0Hs|Los Angeles, California, United States, 90033 Lac+Usc Medical CenterLos Angeles, California, United States, 90033 Usc/Norris Comprehensive Cancer Center / Investigational Drug ServicesLos Angeles, California, United States, 90033 Usc/Norris Comprehensive Cancer CenterLos Angeles, California, United States, 90033 Rrmc - UclaLos Angeles, California, United States, 90095 Ucla Department Of MedicineLos Angeles, California, United States, 90095 Ucla Hematology/Oncology ClinicLos Angeles, California, United States, 90095 Ucla Ronald Reagan Medical CenterLos Angeles, California, United States, 90095 Keck Medicine Of Usc Norris Oncology/Hematology - Newport Beach Treatment CenterNewport Beach, California, United States, 92663 Usc Norris Oncology/Hematology - Newport BeachNewport Beach, California, United States, 92663 Uc Irvine Health - Chao Family Comprehensive Cancer CenterOrange, California, United States, 92868-3201 Uc Irvine Medical CenterOrange, California, United States, 92868-3201 Ucsf Helen Diller Family Comprehensive Cancer CenterSan Francisco, California, United States, 94143 University Of California, San Francisco Medical CenterSan Francisco, California, United States, 94143 University Of California, San FranciscoSan Francisco, California, United States, 94143|Boston, Massachusetts, United States, 02111 Tufts Medical CenterBoston, Massachusetts, United States, 02111 Massachusetts General HospitalBoston, Massachusetts, United States, 02114 Beth|Kansas City, Missouri, United States, 64132|Lake Success, New York, United States, 11042 North Shore University HospitalManhasset, New York, United States, 11030 Long Island Jewish Medical CenterNew Hyde Park, New York, United States, 11040 University Of Rochester Cancer Center PharmacyRochester, New York, United States, 14642 University Of Rochester Medical CenterRochester, New York, United States, 14642|Cleveland, Ohio, United States, 44106 University Hospitals Cleveland Medical CenterCleveland, Ohio, United States, 44106 Cleveland Clinic FoundationCleveland, Ohio, United States, 44195|Portland, Oregon, United States, 97239 Oregon Health & Science University-Research Pharmacy ServicesPortland, Oregon, United States, 97239 Oregon Health & Science UniversityPortland, Oregon, United States, 97239|Nashville, Tennessee, United States, 37203 The Sarah Cannon Research InstituteNashville, Tennessee, United States, 37203 Tristar Bone Marrow TransplantNashville, Tennessee, United States, 37203|Dallas, Texas, United States, 75246 Baylor University Medical CenterDallas, Texas, United States, 75246 Blood Cancer And Stem Cell Transplant ClinicSan Antonio, Texas, United States, 78229 Methodist Healthcare System Of San AntonioSan Antonio, Texas, United States, 78229 Methodist Hospital Investigational PharmacySan Antonio, Texas, United States, 78229|Seattle, Washington, United States, 98104 Swedish First Hill Ids PharmacySeattle, Washington, United States, 98104 Swedish Medical CenterSeattle, Washington, United States, 98122","California|Massachusetts|Missouri|New York|Ohio|Oregon|Tennessee|Texas|Washington","Australia|Austria|Belgium|Canada|China|Czechia|France|Germany|Hungary|Israel|Italy|Japan|Mexico|Poland|Romania|Spain|Sweden|United Kingdom|United States","Australia, 5000 Royal Adelaide Hospital|New South Wales St Vincent's Hospital Sydney|Royal Adelaide Hospital - Clinical Trials Pharmacy|Klinikum Wels-Grieskirchen Gmbh|Landeskrankenhaus Salzburg, Universitatsklinik Fur Innere Medizin Iii Der Pmu|Az Sint-Jan Brugge - Oostende Av|Manitoba Health Sciences Centre|Ontario Sunnybrook Research Institute|Quebec Ciusss De L'Est-De-L'Ile-De- MontrÃ©al - HÃ´pital Maisonneuve-Rosemont|Fujian Fujian Medical University Union Hospital|Guangdong Guangdong Provincial People's Hospital|Henan Henan Cancer Hostipal|Hospital, Sichuan University|Hubei Tongji Hospital, Tongji Medical College, Huazhong University Of Science & Technology/Cancer Center|Jiangsu Jiangsu Province Hospital|Ruijin Hospital Affiliated To Shanghai Jiaotong University School Of Medicine|Shandong Affiliated Hospital Of Qingdao University/Hematology Department|Shanghai Shanghai General Hospital|Tianjin Institute Of Hematology And Blood Diseases Hospital, Chinese Academy Of Medical Sciences|Zhejiang The First Affiliated Hospital College Of Medicine, Zhejiang University|Interni Hematologicka A Onkologicka Klinika, Fakultni Nemocnice Brno|Chu Henri Mondor|Medizinische Hochschule Hannover|North Rhine Westphalia UniversitÃ¤tsklinikum KÃ¶ln|North-Rhine-Westphalia Universitaetsklinikum Muenster|Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Klinika, Hematologia Tanszek|Deaconess Medical Center|Rambam Health Care Campus|An Sod Farmacia-Dipt Dei Servizi -Aou Ospedali Riuniti Umberto I, G.M. Lancisi, G. Salesi|Ancona Aou Ospedali Riuniti Umberto I, G.M. Lancisi, G. Salesi, Clinica Di Ematologia|Azienda Ospedaliero Universitaria Di Bologna Policlinico S.Orsola Malpighi|Fc Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori|Fe A.O.U. Di Ferrara- Arcispedale Sant'Anna,|Pu Ao Ospedali Riuniti Marche Nord - Presidio Ospedaliero San Salvatore Di Pesaro -|Rm Azienda Ospedaliero Universitaria Policlinico Umberto I|Si Azienda Ospedaliera Universitaria Senese.|Aichi Japanese Red Cross Nagoya Daini Hospital|Akita University Hospital|Fukui University Of Fukui Hospital|Gunma Gunma University Hospital|Hyogo Kobe University Hospital|Kanagawa Yokohama City University Medical Center|Miyagi Tohoku University Hospital|Osaka Osaka City University Hospital|Shizuoka Shizuoka Cancer Center|Tokyo National Hospital Organization Disaster Medical Center|Hospital General De MÃ©xico Dr. Eduardo Liceaga|MÃ©x Instituto Nacional De CancerologÃ­a|Klinika Hematologii I Transplantologii Uniwersyteckie Centrum Kliniczne|Cluj Institutul Oncologic 'Prof. Dr. Ion Chiricuta'|Dolj Spitalul Clinic Municipal Filantropia Craiova, Sectia Clinica Hematologie|Spitalul Universitar De Urgenta Militar Central \"Dr. Carol Davila\" Bucuresti|Hospital Del Mar|Sektionen For Hematologi Och Koagulation|, Surrey The Royal Marsden Nhs Foundation Trust|, West Midlands University Hospitals Birmingham Nhs Foundation Trust|Barts Health Nhs Trust|Keck Hospital Of Usc|Tufts Medical Center Investigational Pharmacy|Midamerica Division, Inc., C/O Research Medical Center|Northwell Health/Monter Cancer Center|Taussig Cancer Center Investigational Pharmacy|Ohsu Center For Health And Healing|Centennial Medical Center|Baylor Scott And White Research Institute|Swedish Cancer Institute",{"$nulls":3},"Pfizer CT.gov Call Center","2019-09-21","2020-05-25T16:39:38.900","2020-05-26T17:10:42.972","NCT03416179"]
["5ecbf4cbfe30261b1a0483c3","NCT03416179","2019-09-27","Pfizer","PFE","Recruiting","A Study Evaluating Intensive Chemotherapy With or Without Glasdegib or Azacitidine With or Without Glasdegib In Patients With Previously Untreated Acute Myeloid Leukemia (BRIGHT AML1019)","Glasdegib|Cytarabine|Daunorubicin|Azacitidine","Hh Inhibitor|DNA Polymerase Inhibitor|Nucleic Acid Synthesis Inhibitor|TOP2 Inhibitor|DNA Mtase Inhibitor","Unknown",null,"Unknown",null,"Phase 3",4,720,"Anticipated","2018-04-20","2021-06-13","OS","Overall Survival",{"$nulls":3},"Glasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).\n\nGlasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).","Two separate registration trials conducted under one protocol number are proposed to adequately and independently evaluate the addition of glasdegib in intensive and non-intensive chemotherapy populations. Each study will have an experimental treatment arm and a placebo arm. Endpoints are the same for each study except where specifically indicated.\n\nAssignment to the Intensive Study or the Non-Intensive Study will be made by the Investigator based on the 2017 European LeukemiaNet (ELN) recommendations.\n\nStudy B1371019 is a randomized (1:1), double-blind, multi-center, placebo controlled study of chemotherapy in combination with glasdegib versus chemotherapy in combination with placebo in adult patients with previously untreated AML.\n\nGlasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).\n\nGlasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).","A RANDOMIZED (1:1), DOUBLE-BLIND, MULTI-CENTER, PLACEBO CONTROLLED STUDY EVALUATING INTENSIVE CHEMOTHERAPY WITH OR WITHOUT GLASDEGIB (PF-04449913) OR AZACITIDINE (AZA) WITH OR WITHOUT GLASDEGIB IN PATIENTS WITH PREVIOUSLY UNTREATED ACUTE MYELOID LEUKEMIA","B1371019","Leukemia, Myeloid, Acute","Acute Leukemia|Acute Myeloid Leukemia|Myeloid Leukemia|Leukemia","Oncology Hematological","Oncology","Experimental|Placebo Comparator","Arm A (Intensive Study)|Arm B (Intensive Study)|Arm A (Non-intensive study)|Arm B (Non-intensive study)","Glasdegib + '7+3' Induction(s)|Placebo + '7+3' Induction(s)|Glasdegib + azacitidine|Placebo + azacitidine","Drug|Procedure","glasdegib|daunorubicin + cytarabine|cytarabine|HSCT|Placebo|azacitidine","Daily Glasdegib (100 mg, PO), beginning on Day 1 and is to continue up to 2 years post randomization.\n\nFollowing consolidation therapy, glasdegib or placebo will be administered daily for up to 2 years after randomization or until they have minimal residual disease (MRD) negative disease, whichever comes first.\n\nDaily Glasdegib (100 mg, PO) or matching placebo will continue throughout Induction(s) and Consolidation therapies regardless of dose modifications/delays in the chemotherapy.|Consolidation with single agent cytarabine 3 g/m2 IV for adults <60 years and 1 g/m2 for adults 60 years over 3 BID on Days 1, 3, and 5, every 28 days for up to 4 cycles or alternative single agent cytarabine consolidation schedules may be used per local prescribing information.|If required, and done per standard of care post Induction(s).|Azacitidine (75 mg/m2, SC or IV) daily for 7 days, in 28 day cycles for as long as they do not meet the criteria for disease progression, unacceptable toxicity, consent withdrawal, or death.|Matching placebo (PO) is to be administered by mouth daily beginning on Day 1 of chemotherapy and will continue if subjects demonstrate reasonable evidence of clinical benefit and do not meet the criteria for progression regardless of any delays/modifications in the chemotherapy treatment. Subjects will continue placebo until disease progression, unacceptable toxicity, consent withdrawal, or death, whichever comes first.","PF-04449913","Arm A (Intensive Study)|Arm B (Intensive Study)|Arm A (Non-intensive study)|Arm B (Non-intensive study)","\n\nSubjects must meet all of the following inclusion criteria to be eligible for enrollment into the Intensive and Non Intensive study (unless where indicated):\n\n 1.  Subjects with untreated AML according to the World Health Organization (WHO) 2016 Classification2, including those with: * AML arising from MDS or another antecedent hematologic disease (AHD).\n      * AML after previous cytotoxic therapy or radiation (secondary AML).\n     \n     \n 2.  18 years of age (In Japan, 20 years of age).\n 3.  Adequate Organ Function as defined by the following: * Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) 3 x upper limit of normal (ULN), excluding subjects with liver function abnormalities due to underlying malignancy.\n      * Total serum bilirubin 2 x ULN (except subjects with documented Gilbert's syndrome).\n      * Estimated creatinine clearance 30 mL/min as calculated using the standard method for the institution.\n     \n     \n 4.  QTc interval 470 msec using the Fridericia correction (QTcF).\n 5.  All anti cancer treatments (unless specified) should be discontinued 2 weeks from study entry, for example: targeted chemotherapy, radiotherapy, investigational agents, hormones, anagrelide or cytokines. * For control of rapidly progressing leukemia, all trans retinoic acid (ATRA), hydroxyurea, and/or leukopheresis may be used before and for up to 1 week after the first dose of glasdegib.\n     \n     \n 6.  Serum or urine pregnancy test (for female subjects of childbearing potential) with a minimum sensitivity of 25 IU/L or equivalent units of human chorionic gonadotropin (hCG) negative at screening.\n 7.  Male and female subjects of childbearing potential and at risk for pregnancy must agree to use at least one highly effective method of contraception throughout the study and for 180 days after the last dose of azacitidine, cytarabine, or daunorubicin; and the last dose of glasdegib or placebo, whichever occurs later.\n 8.  Female subjects of non childbearing potential must meet at least 1 of the following criteria: 1. Have undergone a documented hysterectomy and/or bilateral oophorectomy;\n      2. Have medically confirmed ovarian failure; or\n      3. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; status may be confirmed by having a serum follicle stimulating hormone (FSH) level confirming the postmenopausal state.\n     \n     All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential.\n     \n     \n 9.  Consent to a saliva sample collection for a germline comparator, unless prohibited by local regulations or ethics committee (EC) decision.\n 10. Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.\n 11. Subjects who are willing and able to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures (including bone marrow [BM] assessments).\n\n","\n\nSubjects with any of the following characteristics/conditions will not be included in the study:\n\n 1.  Acute Promyelocytic Leukemia (APL) and APLwith PML RARA, subjects (WHO 2016 classification).\n 2.  AML with BCR ABL1 or t(9;22)(q34;q11.2) as a sole abnormality. * Complex genetics may include t(9;22) cytogenetic translocation.\n     \n     \n 3.  Subjects with known active CNS leukemia.\n 4.  Participation in other clinical studies involving other investigational drug(s) (Phases 1 4) within 4 weeks prior study entry and/or during study participation.\n 5.  Subjects known to be refractory to platelet or packed red cell transfusions per Institutional Guidelines, or a patient who refuses blood product support.\n 6.  Subjects with another active malignancy on treatment with the exception of basal cell carcinoma, non melanoma skin cancer, cervical carcinoma in situ. Other prior or concurrent malignancies will be considered on a case by case basis.\n 7.  Any one of the following ongoing or in the previous 6 months: myocardial infarction, congenital long QT syndrome, Torsades de pointes, symptomatic arrhythmias (including sustained ventricular tachyarrhythmia), right or left bundle branch block and bifascicular block, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (CHF New York Heart Association class III or IV), cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism; as well as bradycardia defined as <50 bpms.\n 8.  Subjects with an active, life threatening or clinically significant uncontrolled systemic infection not related to AML.\n 9.  Subjects with left ventricular ejection fraction (LVEF) <50% are excluded from the Intensive Chemotherapy Study only.\n 10. Cumulative anthracycline dose equivalent of 550 mg/m2 of daunorubicin for the Intensive Chemotherapy Study only.\n 11. Known malabsorption syndrome or other condition that may significantly impair absorption of study medication in the investigator's judgment (eg, gastrectomy, lap band, Crohn's disease) and inability or unwillingness to swallow tablets or capsules.\n 12. Current use or anticipated requirement for drugs that are known strong CYP3A4/5 inducers.\n 13. Concurrent administration of herbal preparations.\n 14. Major surgery or radiation within 4 weeks of starting study treatment.\n 15. Documented or suspected hypersensitivity to any one of the following: * For subjects assigned to intensive chemotherapy, documented or suspected hypersensitivity to cytarabine (not including drug fever or exanthema, including known cerebellar side effects) or daunorubicin.\n      * For subjects assigned to non intensive chemotherapy, documented or suspected hypersensitivity to azacitidine or mannitol.\n     \n     \n 16. Known active drug or alcohol abuse.\n 17. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.\n 18. Pregnant females or breastfeeding female subjects.\n 19. Known recent or active suicidal ideation or behavior.\n 20. Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.","FSH",null,"Protein","Ovary","Actual","2018-01-31","Actual","Anticipated","2025-07-22","Anticipated","2019-09-01","2017-12-21","2018-01-23","2019-09-26","Yes","glasdegib;\nuntreated;\nHedgehog Inhibitor","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"All",null,"No","Yes\nPfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",null,"URL: https://pmiform.com/clinical-trial-info-request?StudyID=B1371019 [https://pmiform.com/clinical-trial-info-request?StudyID=B1371019] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To obtain contact information for a study center near you, click here.",null,"Yes","No",{"$nulls":17},"2017-002822-19|BRIGHT|BRIGHT AML1019","EudraCT Number|Alias Study Number","Overall survival","5 years after last subject randomized",null,"Fatigue score measured by the MD Anderson Symptom Inventory (MDASI)-AML/MDS questionnaire|Rate of Complete Remission (CR) (including CR with minimal residual disease (MRD)-negative as assessed by multiparametric flow cytometry)|Duration of response (defined as CR [includes CR-MRD negative]/CRi or CR/CRh as appropriate)|Time to response (CR[includes CR-MRD negative)]/CR with partial hematologic rcovery (CRh) as appropriate)|Event-free Survival|Patient Reported Outcomes (PROs) as measured by the M.D. Anderson Symptom Inventory AML/MDS Module (MDASI-AML/MDS)|Adverse events as graded by NCI CTCAE v4.03|Laboratory abnormalities as graded by NCI CTCAE v4.03|For the intensive study, the plasma trough concentration (Ctrough) will be analyzed|QTc interval|PROs as measured by Patient Global Impression of Change (PGIC)|Patient Reported Outcomes (PROs) as measured by EuroQoL 5 Dimension questionnaire 5-Level version (EQ-5D-5L)|Patient Reported Outcomes (PROs) as measured by Patient Global Impression of Symptoms (PGIS)|Complete Remission with incomplete hematologic recovery (CRi)|Rate of morphological leukemia-free state (MLFS)|Rate of Partial Remission (PR)|Rate of Complete Remission with partial hematological recovery (CRh) for the Non-intensive study only only|Minimum Observed Plasma Trough Concentratrion of glasdegib in the Intensive Study|Minimum Observed Plasma Trough Concentration of glasdegib in the Non-intensive study","Scale is from 0-10 where 0 is not present and 10 is as bad as you can image.|Response as defined by the 2017 European LeukemiaNet (ELN) recommendations.|5 years after last subject randomized, consent withdrawal, or death|Measurement Scale from 0-10.|PK samples taken on Induction(s) Day 1 (1 and 4 hours post induction); Induction(s) Day 10 (pre-dose, 1 and 4 hours post dose); Day 1 of each Consolidation cycle (pre-dose, 1 and 4 hours post dose)|One question asking for description of leukemia symptoms.|Series of questions that ask for information that best describes health.|One question asking for information regarding leukemia symptoms.|Its the minimum trough concentration in plasma of glasdegib following multiple daily dosing to steady state.|It is the minimum trough concentration in plasma of glasdegib following multiple daily dosing to steady state.","5 years after last subject randomized, consent withdrawal, or death|2 years after last dose of study therapy|5 years after last patient randomized, withdrawal, or death|5 years after last subject randomized, withdrawal, or death|Day 10 of Induction Cycle and Day 1 of each Consolidation Cycle|Cycle 1 Day 15 and Cycles 2 and 3 on Day 1","ClinicalTrials.gov_Inquiries@pfizer.com","Pfizer CT.gov Call Center","1-800-718-1021","Adelaide, South|Darlinghurst, New South Wales, Australia, 2010 St George HospitalKogarah, New South Wales, Australia, 2217|Wels, Upper|Salzburg, Austria, 5020 Uniklinikum Salzburg, Landeskrankenhaus SalzburgSalzburg, Austria, 5020 Klinikum Wels-Grieskirchen GmbhWels, Austria, 4600 Sozialmedizinisches Zentrum Sud.Wien, Austria, 1100 Krankenhaus Hietzing Mit Neurologischem Zentrum RosenhugelWien, Austria, 1130|Brugge, Belgium, B-8000 Az Sint-Jan Brugge-Oostende AvBrugge, Belgium, B-8000 Universitaire Ziekenhuizen Brussel (Uz Brussel)Brussels, Belgium, B-1090 Universitaire Ziekenhuizen BrusselBrussels, Belgium, B-1090 Universitaire Ziekenhuizen LeuvenLeuven, Belgium, B-3000|Winnipeg, Manitoba, Canada, R3A 1R9 Cancercare ManitobaWinnipeg, Manitoba, Canada, R3E 0V9|Toronto, Ontario, Canada, M4N 3M5 Princess Margaret Cancer CentreToronto, Ontario, Canada, M5G 2M9|Montreal, Quebec, Canada, H1T 2M4|Fuzhou, Fujian, China, 350001|Guangzhou, Guangdong, China, 510080 Guangdong Second Provincial General HospitalGuangzhou, Guangdong, China, 510317|Zhengzhou, Henan, China, 450008|Chengdu, Sichuan, China, 610041|Wuhan, Hubei, China, 430030|Nanjing, Jiangsu, China, 210029|Shanghai, China, 200025|Qingdao, Shandong, China, 266071|Shanghai, Shanghai, China, 200080|Xi'An, Shannxi, China, 710061|Tianjin, Tianjin, China, 300020|Hangzhou, Zhejiang, China, 310003|Brno, Czechia, 100 34 Nemocnicni LekarnaBrno, Czechia, 625 00 Ustavni LekarnaOstrava - Poruba, Czechia, 708 52 Klinika HematoonkologieOstrava-Poruba, Czechia, 708 52 InternÃ­ HematologickÃ¡ Klinika, Fakultni Nemocnice KrÃ¡lovskÃ© VinohradyPraha 10, Czechia, 100 34 Ãšstavni LÃ©kÃ¡rnaPraha 10, Czechia, 100 34|Creteil, France, 94010 Chu Henri MondorCrÃ©teil, France, 94010 Chu De NantesNantes Cedex 1, France, 44093 Chu De Nantes Hotel DieuNantes Cedex, France, 44093 Hopital Saint LouisParis, France, 75010 Centre Hospitalier Lyon Sud - Service D'HematologiePierre Benite Cedex, France, 69495 Centre Hospitalier Lyon Sud -Unite De Pharmacie Clinique OncologiquePierre Benite Cedex, France, 69495 Institut Gustave RoussyVillejuif Cedex, France, 94805|Hannover, Germany, 30625 UniversitÃ¤tsklinikum KÃ¶lnKoeln, Germany, 50937 Philipps-Universitaet MarburgMarburg, Germany, 35032|Koeln, North Rhine Westphalia, Germany, 50937|Muenster, North-Rhine-Westphalia, Germany, 48149|Debrecen, Hungary, 4032 Debreceni Egyetem Klinikai Kozpont Belgyogyaszati KlinikaDebrecen, Hungary, 4032 Petz AladÃ¡r Megyei OktatÃ³ KÃ³rhÃ¡z, GyÃ³gyszerÃ©szeti OsztÃ¡lyGyÅ‘r, Hungary, 9024 Petz AladÃ¡r Megyei OktatÃ³ KÃ³rhÃ¡z, Ii. BelgyÃ³gyÃ¡szat- HematolÃ³giai OsztÃ¡lyGyÅ‘r, Hungary, 9024 Somogy Megyei Kaposi Mor Oktato KorhazKaposvar, Hungary, 7400 Szabolcs-Szatmar Bereg Megyei Korhazak Es Egyetemi Oktatokorhaz, Josa Andras Korhaz, HematologiaNyiregyhaza, Hungary, 4400 Szabolcs-Szatmar Bereg Megyei Korhazak Es Egyetemi Oktatokorhaz, Josa Andras Korhaz,Nyiregyhaza, Hungary, 4400|Boston, Massachusetts, United States, 02215|Haifa, Israel, 3109601 Shaare Zedek Medical CenterJerusalem, Israel, 9103102 Hadassah Medical Center (Ein Kerem)Jerusalem, Israel, 91120 Hemato-Oncology Ambulatory ServicePetah Tikva, Israel, 4941492 Hematology Division - Oncology PharmacyPetah Tikva, Israel, 4941492 Rabin Medical Center, Beilinson HospitalPetah Tikva, Israel, 4941492 Tel-Aviv Sourasky Medical CenterTel Aviv, Israel, 6423906|Torette Di Ancona, An, Italy, 60126|Torrette Di Ancona, Ancona, Italy, 60126|Bologna, Italy, 40138 Azienda Ospedaliera Universitaria SeneseSiena, Italy, 53100|Meldola, Fc, Italy, 47014|Cona, Ferrara, Fe, Italy, 44124 Farmacia OspedalieraFerrara, Fe, Italy, 44121|Pesaro, Pu, Italy, 61122|Roma, Rm, Italy, 00161|Siena, Si, Italy, 53100|Nagoya, Aichi, Japan, 466-8650|Akita, Japan, 010-8543 Kyushu University HospitalFukuoka, Japan, 812-8582 National Hospital Organization Kumamoto Medical Center[Active, Not Recruiting]Kumamoto, Japan, 860-0008 Nagasaki University HospitalNagasaki, Japan, 852-8501 Tokyo Medical University HospitalTokyo, Japan, 160-0023 Korea, Republic Of, Jeollabuk-Do Chonbuk National University HospitalJeonju-Si, Jeollabuk-Do, Korea, Republic Of, 54907 Korea, Republic Of, Jeollanam-Do Chonnam National University Hwasun HospitalHwasun-Gun, Jeollanam-Do, Korea, Republic Of, 58128 Korea, Republic Of Department Of Pharmacy, Inje University Busan Paik HospitalBusan, Korea, Republic Of, 47392 Inje University Busan Paik HospitalBusan, Korea, Republic Of, 47392 Clinical Trial Pharmacy, Keimyung University Dongsan HospitalDaegu, Korea, Republic Of, 42601 Keimyung University Dongsan HospitalDaegu, Korea, Republic Of, 42601 Gachon University Gil Medical CenterIncheon, Korea, Republic Of, 21565 Seoul National University HospitalSeoul, Korea, Republic Of, 03080 Clinical Trial Center, Severance Hospital, Yonsei University Health SystemSeoul, Korea, Republic Of, 03722 Severance Hospital, Yonsei University Health SystemSeoul, Korea, Republic Of, 03722 Department Of Pharmacy, Samsung Medical CenterSeoul, Korea, Republic Of, 06351 Samsung Medical CenterSeoul, Korea, Republic Of, 06351 Department Of Pharmacy, Severance Hospital, Yonsei University Health SystemSeoul, Korea, Republic Of, 06591 The Catholic University Of Korea Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591 The Catholic University Of Korea, Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591|Yoshida-Gun, Fukui, Japan, 910-1193|Maebashi, Gunma, Japan, 371-8511|Kobe-Shi, Hyogo, Japan, 650-0017|Yokohama, Kanagawa, Japan, 232-0024|Sendai, Miyagi, Japan, 980-8574|Osaka-City, Osaka, Japan, 545-8586 Kindai University HospitalOsaka-Sayama, Osaka, Japan, 589-8511|Sunto-Gun, Shizuoka, Japan, 411-8777|Tachikawa, Tokyo, Japan, 190-0014|MÃ©xico, Mexico, 06726|MÃ©xico, MÃ©x, Mexico, 14080|Gdansk, Poland, 80-214 Wwcoit Im. M. Kopernika W LodziLodz, Poland, 93-513|Cluj-Napoca, Cluj, Romania, 400124|Craiova, Dolj, Romania, 200136|Bucuresti, Romania, 010825 Spitalul Clinic Coltea, Clinica De HematologieBucuresti, Romania, 030171 Russian Federation Sbhi Cch No. 40 Hd MoscowMoscow, Russian Federation, 129301 State Budgetary Healthcare Institution Of MoscowMoscow, Russian Federation, 129301 Sbhi Nnr Nn Rch N. A. N.A. SemashkoNizhniy Novgorod, Russian Federation, 603126 State Budgetary Institution Of Ryazan Region 'Regional Clinical Hospital' (Sbi Rr Rch)Ryazan, Russian Federation, 390039 Fsbi Russrhti Fmba Of|Barcelona, Spain, 08003 Hospital De La Santa Creu I Sant PauBarcelona, Spain, 08025 Hospital Universitario Arnau De VilanovaLleida, Spain, 25198 Hospital General Universitario Gregorio MaranonMadrid, Spain, 28007 Hospital Universitario Ramon Y CajalMadrid, Spain, 28034 Hospital Universitario Virgen Del RocioSevilla, Spain, 41013 Hospital Universitari I Politecnic La FeValencia, Spain, 46026|Goteborg, Sweden, 413 45 Apl, Apl Sahlgrenska, Kliniska ProvningarGoteborg, Sweden, 413 46 Apoex VnOrebro, Sweden, 701 85 Universitetssjukhuset OrebroOrebro, Sweden, 701 85 Apoex Ab Nks, Kliniska ProvningarSolna, Sweden, 171 64 Karolinska Universitetssjukhuset HuddingeStockholm, Sweden, 141 86 Taiwan National Cheng Kung University HospitalTainan, Taiwan, 704 National Taiwan University HospitalTaipei, Taiwan, 100 Department Of Clinical Trial Pharmacy, Taipei Veterans General HospitalTaipei, Taiwan, 11217 Taipei Veterans General HospitalTaipei, Taiwan, 11217 Division Of Pharmacy, Koo Foundation Sun Yat-Sen Cancer CenterTaipei, Taiwan, 112 Koo Foundation Sun Yat-Sen Cancer CenterTaipei, Taiwan, 112 Chang Gung Memorial Hospital-Linkou BranchTaoyuan City, Taiwan, 333 Chemotherapy Pharmacy, Chang Gung Memorial Hospital-Linkou BranchTaoyuan City, Taiwan, 333|Sutton, Surrey, United Kingdom, Sm2 5Pt|Birmingham, West Midlands, United Kingdom, B15 2Th University Hospitals Birmingham Nhs Foundation TrustBirmingham, West Midlands, United Kingdom, B30 3Hg|London, United Kingdom, Ec1A 7Be Imperial College Healthcare Nhs TrustLondon, United Kingdom, W12 0Hs|Los Angeles, California, United States, 90033 Lac+Usc Medical CenterLos Angeles, California, United States, 90033 Usc/Norris Comprehensive Cancer Center / Investigational Drug ServicesLos Angeles, California, United States, 90033 Usc/Norris Comprehensive Cancer CenterLos Angeles, California, United States, 90033 Rrmc - UclaLos Angeles, California, United States, 90095 Ucla Department Of MedicineLos Angeles, California, United States, 90095 Ucla Hematology/Oncology ClinicLos Angeles, California, United States, 90095 Ucla Ronald Reagan Medical CenterLos Angeles, California, United States, 90095 Keck Medicine Of Usc Norris Oncology/Hematology - Newport Beach Treatment CenterNewport Beach, California, United States, 92663 Usc Norris Oncology/Hematology - Newport BeachNewport Beach, California, United States, 92663 Uc Irvine Health - Chao Family Comprehensive Cancer CenterOrange, California, United States, 92868-3201 Uc Irvine Medical CenterOrange, California, United States, 92868-3201 Ucsf Helen Diller Family Comprehensive Cancer CenterSan Francisco, California, United States, 94143 University Of California, San Francisco Medical CenterSan Francisco, California, United States, 94143 University Of California, San FranciscoSan Francisco, California, United States, 94143|Boston, Massachusetts, United States, 02111 Tufts Medical CenterBoston, Massachusetts, United States, 02111 Massachusetts General HospitalBoston, Massachusetts, United States, 02114 Beth|Kansas City, Missouri, United States, 64132|Lake Success, New York, United States, 11042 North Shore University HospitalManhasset, New York, United States, 11030 Long Island Jewish Medical CenterNew Hyde Park, New York, United States, 11040 University Of Rochester Cancer Center PharmacyRochester, New York, United States, 14642 University Of Rochester Medical CenterRochester, New York, United States, 14642|Cleveland, Ohio, United States, 44106 University Hospitals Cleveland Medical CenterCleveland, Ohio, United States, 44106 Cleveland Clinic FoundationCleveland, Ohio, United States, 44195|Portland, Oregon, United States, 97239 Oregon Health & Science University-Research Pharmacy ServicesPortland, Oregon, United States, 97239 Oregon Health & Science UniversityPortland, Oregon, United States, 97239|Nashville, Tennessee, United States, 37203 The Sarah Cannon Research InstituteNashville, Tennessee, United States, 37203 Tristar Bone Marrow TransplantNashville, Tennessee, United States, 37203|Dallas, Texas, United States, 75246 Baylor University Medical CenterDallas, Texas, United States, 75246 Blood Cancer And Stem Cell Transplant ClinicSan Antonio, Texas, United States, 78229 Methodist Healthcare System Of San AntonioSan Antonio, Texas, United States, 78229 Methodist Hospital Investigational PharmacySan Antonio, Texas, United States, 78229|Seattle, Washington, United States, 98104 Swedish First Hill Ids PharmacySeattle, Washington, United States, 98104 Swedish Medical CenterSeattle, Washington, United States, 98122","California|Massachusetts|Missouri|New York|Ohio|Oregon|Tennessee|Texas|Washington","Australia|Austria|Belgium|Canada|China|Czechia|France|Germany|Hungary|Israel|Italy|Japan|Mexico|Poland|Romania|Spain|Sweden|United Kingdom|United States","Australia, 5000 Royal Adelaide Hospital|New South Wales St Vincent's Hospital Sydney|Royal Adelaide Hospital - Clinical Trials Pharmacy|Klinikum Wels-Grieskirchen Gmbh|Landeskrankenhaus Salzburg, Universitatsklinik Fur Innere Medizin Iii Der Pmu|Az Sint-Jan Brugge - Oostende Av|Manitoba Health Sciences Centre|Ontario Sunnybrook Research Institute|Quebec Ciusss De L'Est-De-L'Ile-De- MontrÃ©al - HÃ´pital Maisonneuve-Rosemont|Fujian Fujian Medical University Union Hospital|Guangdong Guangdong Provincial People's Hospital|Henan Henan Cancer Hostipal|Hospital, Sichuan University|Hubei Tongji Hospital, Tongji Medical College, Huazhong University Of Science & Technology/Cancer Center|Jiangsu Jiangsu Province Hospital|Ruijin Hospital Affiliated To Shanghai Jiaotong University School Of Medicine|Shandong Affiliated Hospital Of Qingdao University/Hematology Department|Shanghai Shanghai General Hospital|Shannxi The First Affiliated Hospital Of Xi'An Jiaotong University|Tianjin Institute Of Hematology And Blood Diseases Hospital, Chinese Academy Of Medical Sciences|Zhejiang The First Affiliated Hospital College Of Medicine, Zhejiang University|Interni Hematologicka A Onkologicka Klinika, Fakultni Nemocnice Brno|Chu Henri Mondor|Medizinische Hochschule Hannover|North Rhine Westphalia UniversitÃ¤tsklinikum KÃ¶ln|North-Rhine-Westphalia Universitaetsklinikum Muenster|Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Klinika, Hematologia Tanszek|Deaconess Medical Center|Rambam Health Care Campus|An Sod Farmacia-Dipt Dei Servizi -Aou Ospedali Riuniti Umberto I, G.M. Lancisi, G. Salesi|Ancona Aou Ospedali Riuniti Umberto I, G.M. Lancisi, G. Salesi, Clinica Di Ematologia|Azienda Ospedaliero Universitaria Di Bologna Policlinico S.Orsola Malpighi|Fc Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori|Fe A.O.U. Di Ferrara- Arcispedale Sant'Anna,|Pu Ao Ospedali Riuniti Marche Nord - Presidio Ospedaliero San Salvatore Di Pesaro -|Rm Azienda Ospedaliero Universitaria Policlinico Umberto I|Si Azienda Ospedaliera Universitaria Senese.|Aichi Japanese Red Cross Nagoya Daini Hospital|Akita University Hospital|Fukui University Of Fukui Hospital|Gunma Gunma University Hospital|Hyogo Kobe University Hospital|Kanagawa Yokohama City University Medical Center|Miyagi Tohoku University Hospital|Osaka Osaka City University Hospital|Shizuoka Shizuoka Cancer Center|Tokyo National Hospital Organization Disaster Medical Center|Hospital General De MÃ©xico Dr. Eduardo Liceaga|MÃ©x Instituto Nacional De CancerologÃ­a|Klinika Hematologii I Transplantologii Uniwersyteckie Centrum Kliniczne|Cluj Institutul Oncologic 'Prof. Dr. Ion Chiricuta'|Dolj Spitalul Clinic Municipal Filantropia Craiova, Sectia Clinica Hematologie|Spitalul Universitar De Urgenta Militar Central \"Dr. Carol Davila\" Bucuresti|Hospital Del Mar|Sektionen For Hematologi Och Koagulation|, Surrey The Royal Marsden Nhs Foundation Trust|, West Midlands University Hospitals Birmingham Nhs Foundation Trust|Barts Health Nhs Trust|Keck Hospital Of Usc|Tufts Medical Center Investigational Pharmacy|Midamerica Division, Inc., C/O Research Medical Center|Northwell Health/Monter Cancer Center|Taussig Cancer Center Investigational Pharmacy|Ohsu Center For Health And Healing|Centennial Medical Center|Baylor Scott And White Research Institute|Swedish Cancer Institute",{"$nulls":3},"Pfizer CT.gov Call Center","2019-09-26","2020-05-25T16:39:39.440","2020-05-26T17:10:42.972","NCT03416179"]
["5ecbf4cbfeab101b155309f2","NCT03416179","2019-10-14","Pfizer","PFE","Recruiting","A Study Evaluating Intensive Chemotherapy With or Without Glasdegib or Azacitidine With or Without Glasdegib In Patients With Previously Untreated Acute Myeloid Leukemia (BRIGHT AML1019)","Glasdegib|Cytarabine|Daunorubicin|Azacitidine","Hh Inhibitor|DNA Polymerase Inhibitor|Nucleic Acid Synthesis Inhibitor|TOP2 Inhibitor|DNA Mtase Inhibitor","Unknown",null,"Unknown",null,"Phase 3",4,720,"Anticipated","2018-04-20","2021-06-13","OS","Overall Survival",{"$nulls":3},"Glasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).\n\nGlasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).","Two separate registration trials conducted under one protocol number are proposed to adequately and independently evaluate the addition of glasdegib in intensive and non-intensive chemotherapy populations. Each study will have an experimental treatment arm and a placebo arm. Endpoints are the same for each study except where specifically indicated.\n\nAssignment to the Intensive Study or the Non-Intensive Study will be made by the Investigator based on the 2017 European LeukemiaNet (ELN) recommendations.\n\nStudy B1371019 is a randomized (1:1), double-blind, multi-center, placebo controlled study of chemotherapy in combination with glasdegib versus chemotherapy in combination with placebo in adult patients with previously untreated AML.\n\nGlasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).\n\nGlasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).","A RANDOMIZED (1:1), DOUBLE-BLIND, MULTI-CENTER, PLACEBO CONTROLLED STUDY EVALUATING INTENSIVE CHEMOTHERAPY WITH OR WITHOUT GLASDEGIB (PF-04449913) OR AZACITIDINE (AZA) WITH OR WITHOUT GLASDEGIB IN PATIENTS WITH PREVIOUSLY UNTREATED ACUTE MYELOID LEUKEMIA","B1371019","Leukemia, Myeloid, Acute","Acute Leukemia|Acute Myeloid Leukemia|Myeloid Leukemia|Leukemia","Oncology Hematological","Oncology","Experimental|Placebo Comparator","Arm A (Intensive Study)|Arm B (Intensive Study)|Arm A (Non-intensive study)|Arm B (Non-intensive study)","Glasdegib + '7+3' Induction(s)|Placebo + '7+3' Induction(s)|Glasdegib + azacitidine|Placebo + azacitidine","Drug|Procedure","glasdegib|daunorubicin + cytarabine|cytarabine|HSCT|Placebo|azacitidine","Daily Glasdegib (100 mg, PO), beginning on Day 1 and is to continue up to 2 years post randomization.\n\nFollowing consolidation therapy, glasdegib or placebo will be administered daily for up to 2 years after randomization or until they have minimal residual disease (MRD) negative disease, whichever comes first.\n\nDaily Glasdegib (100 mg, PO) or matching placebo will continue throughout Induction(s) and Consolidation therapies regardless of dose modifications/delays in the chemotherapy.|Consolidation with single agent cytarabine 3 g/m2 IV for adults <60 years and 1 g/m2 for adults 60 years over 3 BID on Days 1, 3, and 5, every 28 days for up to 4 cycles or alternative single agent cytarabine consolidation schedules may be used per local prescribing information.|If required, and done per standard of care post Induction(s).|Azacitidine (75 mg/m2, SC or IV) daily for 7 days, in 28 day cycles for as long as they do not meet the criteria for disease progression, unacceptable toxicity, consent withdrawal, or death.|Matching placebo (PO) is to be administered by mouth daily beginning on Day 1 of chemotherapy and will continue if subjects demonstrate reasonable evidence of clinical benefit and do not meet the criteria for progression regardless of any delays/modifications in the chemotherapy treatment. Subjects will continue placebo until disease progression, unacceptable toxicity, consent withdrawal, or death, whichever comes first.","PF-04449913","Arm A (Intensive Study)|Arm B (Intensive Study)|Arm A (Non-intensive study)|Arm B (Non-intensive study)","\n\nSubjects must meet all of the following inclusion criteria to be eligible for enrollment into the Intensive and Non Intensive study (unless where indicated):\n\n 1.  Subjects with untreated AML according to the World Health Organization (WHO) 2016 Classification2, including those with: * AML arising from MDS or another antecedent hematologic disease (AHD).\n      * AML after previous cytotoxic therapy or radiation (secondary AML).\n     \n     \n 2.  18 years of age (In Japan, 20 years of age).\n 3.  Adequate Organ Function as defined by the following: * Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) 3 x upper limit of normal (ULN), excluding subjects with liver function abnormalities due to underlying malignancy.\n      * Total serum bilirubin 2 x ULN (except subjects with documented Gilbert's syndrome).\n      * Estimated creatinine clearance 30 mL/min as calculated using the standard method for the institution.\n     \n     \n 4.  QTc interval 470 msec using the Fridericia correction (QTcF).\n 5.  All anti cancer treatments (unless specified) should be discontinued 2 weeks from study entry, for example: targeted chemotherapy, radiotherapy, investigational agents, hormones, anagrelide or cytokines. * For control of rapidly progressing leukemia, all trans retinoic acid (ATRA), hydroxyurea, and/or leukopheresis may be used before and for up to 1 week after the first dose of glasdegib.\n     \n     \n 6.  Serum or urine pregnancy test (for female subjects of childbearing potential) with a minimum sensitivity of 25 IU/L or equivalent units of human chorionic gonadotropin (hCG) negative at screening.\n 7.  Male and female subjects of childbearing potential and at risk for pregnancy must agree to use at least one highly effective method of contraception throughout the study and for 180 days after the last dose of azacitidine, cytarabine, or daunorubicin; and the last dose of glasdegib or placebo, whichever occurs later.\n 8.  Female subjects of non childbearing potential must meet at least 1 of the following criteria: 1. Have undergone a documented hysterectomy and/or bilateral oophorectomy;\n      2. Have medically confirmed ovarian failure; or\n      3. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; status may be confirmed by having a serum follicle stimulating hormone (FSH) level confirming the postmenopausal state.\n     \n     All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential.\n     \n     \n 9.  Consent to a saliva sample collection for a germline comparator, unless prohibited by local regulations or ethics committee (EC) decision.\n 10. Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.\n 11. Subjects who are willing and able to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures (including bone marrow [BM] assessments).\n\n","\n\nSubjects with any of the following characteristics/conditions will not be included in the study:\n\n 1.  Acute Promyelocytic Leukemia (APL) and APLwith PML RARA, subjects (WHO 2016 classification).\n 2.  AML with BCR ABL1 or t(9;22)(q34;q11.2) as a sole abnormality. * Complex genetics may include t(9;22) cytogenetic translocation.\n     \n     \n 3.  Subjects with known active CNS leukemia.\n 4.  Participation in other clinical studies involving other investigational drug(s) (Phases 1 4) within 4 weeks prior study entry and/or during study participation.\n 5.  Subjects known to be refractory to platelet or packed red cell transfusions per Institutional Guidelines, or a patient who refuses blood product support.\n 6.  Subjects with another active malignancy on treatment with the exception of basal cell carcinoma, non melanoma skin cancer, cervical carcinoma in situ. Other prior or concurrent malignancies will be considered on a case by case basis.\n 7.  Any one of the following ongoing or in the previous 6 months: myocardial infarction, congenital long QT syndrome, Torsades de pointes, symptomatic arrhythmias (including sustained ventricular tachyarrhythmia), right or left bundle branch block and bifascicular block, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (CHF New York Heart Association class III or IV), cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism; as well as bradycardia defined as <50 bpms.\n 8.  Subjects with an active, life threatening or clinically significant uncontrolled systemic infection not related to AML.\n 9.  Subjects with left ventricular ejection fraction (LVEF) <50% are excluded from the Intensive Chemotherapy Study only.\n 10. Cumulative anthracycline dose equivalent of 550 mg/m2 of daunorubicin for the Intensive Chemotherapy Study only.\n 11. Known malabsorption syndrome or other condition that may significantly impair absorption of study medication in the investigator's judgment (eg, gastrectomy, lap band, Crohn's disease) and inability or unwillingness to swallow tablets or capsules.\n 12. Current use or anticipated requirement for drugs that are known strong CYP3A4/5 inducers.\n 13. Concurrent administration of herbal preparations.\n 14. Major surgery or radiation within 4 weeks of starting study treatment.\n 15. Documented or suspected hypersensitivity to any one of the following: * For subjects assigned to intensive chemotherapy, documented or suspected hypersensitivity to cytarabine (not including drug fever or exanthema, including known cerebellar side effects) or daunorubicin.\n      * For subjects assigned to non intensive chemotherapy, documented or suspected hypersensitivity to azacitidine or mannitol.\n     \n     \n 16. Known active drug or alcohol abuse.\n 17. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.\n 18. Pregnant females or breastfeeding female subjects.\n 19. Known recent or active suicidal ideation or behavior.\n 20. Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.","FSH",null,"Protein","Ovary","Actual","2018-01-31","Actual","Anticipated","2025-07-22","Anticipated","2019-10-01","2017-12-21","2018-01-23","2019-10-10","Yes","glasdegib;\nuntreated;\nHedgehog Inhibitor","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"All",null,"No","Yes\nPfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",null,"URL: https://pmiform.com/clinical-trial-info-request?StudyID=B1371019 [https://pmiform.com/clinical-trial-info-request?StudyID=B1371019] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To obtain contact information for a study center near you, click here.",null,"Yes","No",{"$nulls":17},"2017-002822-19|BRIGHT|BRIGHT AML1019","EudraCT Number|Alias Study Number","Overall survival","5 years after last subject randomized",null,"Fatigue score measured by the MD Anderson Symptom Inventory (MDASI)-AML/MDS questionnaire|Rate of Complete Remission (CR) (including CR with minimal residual disease (MRD)-negative as assessed by multiparametric flow cytometry)|Duration of response (defined as CR [includes CR-MRD negative]/CRi or CR/CRh as appropriate)|Time to response (CR[includes CR-MRD negative)]/CR with partial hematologic rcovery (CRh) as appropriate)|Event-free Survival|Patient Reported Outcomes (PROs) as measured by the M.D. Anderson Symptom Inventory AML/MDS Module (MDASI-AML/MDS)|Adverse events as graded by NCI CTCAE v4.03|Laboratory abnormalities as graded by NCI CTCAE v4.03|For the intensive study, the plasma trough concentration (Ctrough) will be analyzed|QTc interval|PROs as measured by Patient Global Impression of Change (PGIC)|Patient Reported Outcomes (PROs) as measured by EuroQoL 5 Dimension questionnaire 5-Level version (EQ-5D-5L)|Patient Reported Outcomes (PROs) as measured by Patient Global Impression of Symptoms (PGIS)|Complete Remission with incomplete hematologic recovery (CRi)|Rate of morphological leukemia-free state (MLFS)|Rate of Partial Remission (PR)|Rate of Complete Remission with partial hematological recovery (CRh) for the Non-intensive study only only|Minimum Observed Plasma Trough Concentratrion of glasdegib in the Intensive Study|Minimum Observed Plasma Trough Concentration of glasdegib in the Non-intensive study","Scale is from 0-10 where 0 is not present and 10 is as bad as you can image.|Response as defined by the 2017 European LeukemiaNet (ELN) recommendations.|5 years after last subject randomized, consent withdrawal, or death|Measurement Scale from 0-10.|PK samples taken on Induction(s) Day 1 (1 and 4 hours post induction); Induction(s) Day 10 (pre-dose, 1 and 4 hours post dose); Day 1 of each Consolidation cycle (pre-dose, 1 and 4 hours post dose)|One question asking for description of leukemia symptoms.|Series of questions that ask for information that best describes health.|One question asking for information regarding leukemia symptoms.|Its the minimum trough concentration in plasma of glasdegib following multiple daily dosing to steady state.|It is the minimum trough concentration in plasma of glasdegib following multiple daily dosing to steady state.","5 years after last subject randomized, consent withdrawal, or death|2 years after last dose of study therapy|5 years after last patient randomized, withdrawal, or death|5 years after last subject randomized, withdrawal, or death|Day 10 of Induction Cycle and Day 1 of each Consolidation Cycle|Cycle 1 Day 15 and Cycles 2 and 3 on Day 1","ClinicalTrials.gov_Inquiries@pfizer.com","Pfizer CT.gov Call Center","1-800-718-1021","Adelaide, South|Darlinghurst, New South Wales, Australia, 2010 St George HospitalKogarah, New South Wales, Australia, 2217|Wels, Upper|Salzburg, Austria, 5020 Uniklinikum Salzburg, Landeskrankenhaus SalzburgSalzburg, Austria, 5020 Klinikum Wels-Grieskirchen GmbhWels, Austria, 4600 Sozialmedizinisches Zentrum Sud.Wien, Austria, 1100 Krankenhaus Hietzing Mit Neurologischem Zentrum RosenhugelWien, Austria, 1130|Brugge, Belgium, B-8000 Az Sint-Jan Brugge-Oostende AvBrugge, Belgium, B-8000 Universitaire Ziekenhuizen Brussel (Uz Brussel)Brussels, Belgium, B-1090 Universitaire Ziekenhuizen BrusselBrussels, Belgium, B-1090 Universitaire Ziekenhuizen LeuvenLeuven, Belgium, B-3000|Winnipeg, Manitoba, Canada, R3A 1R9 Cancercare ManitobaWinnipeg, Manitoba, Canada, R3E 0V9|Toronto, Ontario, Canada, M4N 3M5 Princess Margaret Cancer CentreToronto, Ontario, Canada, M5G 2M9|Montreal, Quebec, Canada, H1T 2M4|Hefei, Anhui, China, 230001 Anhui Provincial HospitalHefei, Anhui, China, 230071|Fuzhou, Fujian, China, 350001|Guangzhou, Guangdong, China, 510080 Guangdong Second Provincial General HospitalGuangzhou, Guangdong, China, 510317|Langfang, Hebei, China, 065201|Zhengzhou, Henan, China, 450008|Chengdu, Sichuan, China, 610041|Wuhan, Hubei, China, 430030|Nanjing, Jiangsu, China, 210029|Shanghai, China, 200025|Qingdao, Shandong, China, 266071|Shanghai, Shanghai, China, 200080|Xi'An, Shannxi, China, 710061|Tianjin, Tianjin, China, 300020|Hangzhou, Zhejiang, China, 310003|Brno, Czechia, 100 34 Nemocnicni LekarnaBrno, Czechia, 625 00 Ustavni LekarnaOstrava - Poruba, Czechia, 708 52 Klinika HematoonkologieOstrava-Poruba, Czechia, 708 52 InternÃ­ HematologickÃ¡ Klinika, Fakultni Nemocnice KrÃ¡lovskÃ© VinohradyPraha 10, Czechia, 100 34 Ãšstavni LÃ©kÃ¡rnaPraha 10, Czechia, 100 34|Creteil, France, 94010 Chu Henri MondorCrÃ©teil, France, 94010 Chu De NantesNantes Cedex 1, France, 44093 Chu De Nantes Hotel DieuNantes Cedex, France, 44093 Hopital Saint LouisParis, France, 75010 Centre Hospitalier Lyon Sud - Service D'HematologiePierre Benite Cedex, France, 69495 Centre Hospitalier Lyon Sud -Unite De Pharmacie Clinique OncologiquePierre Benite Cedex, France, 69495 Institut Gustave RoussyVillejuif Cedex, France, 94805|Koeln, North Rhine Westphalia, Germany, 50937|Muenster, North-Rhine-Westphalia, Germany, 48149|Hamburg, Germany, 20246 Medizinische Hochschule HannoverHannover, Germany, 30625 UniversitÃ¤tsklinikum KÃ¶lnKoeln, Germany, 50937 Philipps-Universitaet MarburgMarburg, Germany, 35032|Debrecen, Hungary, 4032 Debreceni Egyetem Klinikai Kozpont Belgyogyaszati KlinikaDebrecen, Hungary, 4032 Petz AladÃ¡r Megyei OktatÃ³ KÃ³rhÃ¡z, GyÃ³gyszerÃ©szeti OsztÃ¡lyGyÅ‘r, Hungary, 9024 Petz AladÃ¡r Megyei OktatÃ³ KÃ³rhÃ¡z, Ii. BelgyÃ³gyÃ¡szat- HematolÃ³giai OsztÃ¡lyGyÅ‘r, Hungary, 9024 Somogy Megyei Kaposi Mor Oktato KorhazKaposvar, Hungary, 7400 Szabolcs-Szatmar Bereg Megyei Korhazak Es Egyetemi Oktatokorhaz, Josa Andras Korhaz, HematologiaNyiregyhaza, Hungary, 4400 Szabolcs-Szatmar Bereg Megyei Korhazak Es Egyetemi Oktatokorhaz, Josa Andras Korhaz,Nyiregyhaza, Hungary, 4400|Boston, Massachusetts, United States, 02215|Haifa, Israel, 3109601 Shaare Zedek Medical CenterJerusalem, Israel, 9103102 Hadassah Medical Center (Ein Kerem)Jerusalem, Israel, 91120 Hemato-Oncology Ambulatory ServicePetah Tikva, Israel, 4941492 Hematology Division - Oncology PharmacyPetah Tikva, Israel, 4941492 Rabin Medical Center, Beilinson HospitalPetah Tikva, Israel, 4941492 Tel-Aviv Sourasky Medical CenterTel Aviv, Israel, 6423906|Torette Di Ancona, An, Italy, 60126|Torrette Di Ancona, Ancona, Italy, 60126|Bologna, Italy, 40138 Azienda Ospedaliera Universitaria SeneseSiena, Italy, 53100|Meldola, Fc, Italy, 47014|Cona, Ferrara, Fe, Italy, 44124 Farmacia OspedalieraFerrara, Fe, Italy, 44121|Pesaro, Pu, Italy, 61122|Roma, Rm, Italy, 00161|Siena, Si, Italy, 53100|Nagoya, Aichi, Japan, 466-8650|Akita, Japan, 010-8543 Kyushu University HospitalFukuoka, Japan, 812-8582 National Hospital Organization Kumamoto Medical Center[Active, Not Recruiting]Kumamoto, Japan, 860-0008 Nagasaki University HospitalNagasaki, Japan, 852-8501 Tokyo Medical University HospitalTokyo, Japan, 160-0023 Korea, Republic Of, Jeollabuk-Do Chonbuk National University HospitalJeonju-Si, Jeollabuk-Do, Korea, Republic Of, 54907 Korea, Republic Of, Jeollanam-Do Chonnam National University Hwasun HospitalHwasun-Gun, Jeollanam-Do, Korea, Republic Of, 58128 Korea, Republic Of Department Of Pharmacy, Inje University Busan Paik HospitalBusan, Korea, Republic Of, 47392 Inje University Busan Paik HospitalBusan, Korea, Republic Of, 47392 Clinical Trial Pharmacy, Keimyung University Dongsan HospitalDaegu, Korea, Republic Of, 42601 Keimyung University Dongsan HospitalDaegu, Korea, Republic Of, 42601 Gachon University Gil Medical CenterIncheon, Korea, Republic Of, 21565 Seoul National University HospitalSeoul, Korea, Republic Of, 03080 Clinical Trial Center, Severance Hospital, Yonsei University Health SystemSeoul, Korea, Republic Of, 03722 Severance Hospital, Yonsei University Health SystemSeoul, Korea, Republic Of, 03722 Department Of Pharmacy, Samsung Medical CenterSeoul, Korea, Republic Of, 06351 Samsung Medical CenterSeoul, Korea, Republic Of, 06351 Department Of Pharmacy, Severance Hospital, Yonsei University Health SystemSeoul, Korea, Republic Of, 06591 The Catholic University Of Korea Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591 The Catholic University Of Korea, Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591|Yoshida-Gun, Fukui, Japan, 910-1193|Maebashi, Gunma, Japan, 371-8511|Kobe-Shi, Hyogo, Japan, 650-0017|Yokohama, Kanagawa, Japan, 232-0024|Sendai, Miyagi, Japan, 980-8574|Osaka-City, Osaka, Japan, 545-8586 Kindai University HospitalOsaka-Sayama, Osaka, Japan, 589-8511|Sunto-Gun, Shizuoka, Japan, 411-8777|Tachikawa, Tokyo, Japan, 190-0014|MÃ©xico, Mexico, 06726|MÃ©xico, MÃ©x, Mexico, 14080|Gdansk, Poland, 80-214 Wwcoit Im. M. Kopernika W LodziLodz, Poland, 93-513|Cluj-Napoca, Cluj, Romania, 400124|Craiova, Dolj, Romania, 200136|Bucuresti, Romania, 010825 Spitalul Clinic Coltea, Clinica De HematologieBucuresti, Romania, 030171 Russian Federation Sbhi Cch No. 40 Hd MoscowMoscow, Russian Federation, 129301 State Budgetary Healthcare Institution Of MoscowMoscow, Russian Federation, 129301 Sbhi Nnr Nn Rch N. A. N.A. SemashkoNizhniy Novgorod, Russian Federation, 603126 State Budgetary Institution Of Ryazan Region 'Regional Clinical Hospital' (Sbi Rr Rch)Ryazan, Russian Federation, 390039 Fsbi Russrhti Fmba Of|Barcelona, Spain, 08003 Hospital De La Santa Creu I Sant PauBarcelona, Spain, 08025 Hospital Universitario Arnau De VilanovaLleida, Spain, 25198 Hospital General Universitario Gregorio MaranonMadrid, Spain, 28007 Hospital Universitario Ramon Y CajalMadrid, Spain, 28034 Hospital Universitario Virgen Del RocioSevilla, Spain, 41013 Hospital Universitari I Politecnic La FeValencia, Spain, 46026|Goteborg, Sweden, 413 45 Apl, Apl Sahlgrenska, Kliniska ProvningarGoteborg, Sweden, 413 46 Apoex VnOrebro, Sweden, 701 85 Universitetssjukhuset OrebroOrebro, Sweden, 701 85 Apoex Ab Nks, Kliniska ProvningarSolna, Sweden, 171 64 Karolinska Universitetssjukhuset HuddingeStockholm, Sweden, 141 86 Taiwan National Cheng Kung University HospitalTainan, Taiwan, 704 National Taiwan University HospitalTaipei, Taiwan, 100 Department Of Clinical Trial Pharmacy, Taipei Veterans General HospitalTaipei, Taiwan, 11217 Taipei Veterans General HospitalTaipei, Taiwan, 11217 Division Of Pharmacy, Koo Foundation Sun Yat-Sen Cancer CenterTaipei, Taiwan, 112 Koo Foundation Sun Yat-Sen Cancer CenterTaipei, Taiwan, 112 Chang Gung Memorial Hospital-Linkou BranchTaoyuan City, Taiwan, 333 Chemotherapy Pharmacy, Chang Gung Memorial Hospital-Linkou BranchTaoyuan City, Taiwan, 333|Sutton, Surrey, United Kingdom, Sm2 5Pt|Birmingham, West Midlands, United Kingdom, B15 2Th University Hospitals Birmingham Nhs Foundation TrustBirmingham, West Midlands, United Kingdom, B30 3Hg|London, United Kingdom, Ec1A 7Be Imperial College Healthcare Nhs TrustLondon, United Kingdom, W12 0Hs|Los Angeles, California, United States, 90033 Lac+Usc Medical CenterLos Angeles, California, United States, 90033 Usc/Norris Comprehensive Cancer Center / Investigational Drug ServicesLos Angeles, California, United States, 90033 Usc/Norris Comprehensive Cancer CenterLos Angeles, California, United States, 90033 Rrmc - UclaLos Angeles, California, United States, 90095 Ucla Department Of MedicineLos Angeles, California, United States, 90095 Ucla Hematology/Oncology ClinicLos Angeles, California, United States, 90095 Ucla Ronald Reagan Medical CenterLos Angeles, California, United States, 90095 Keck Medicine Of Usc Norris Oncology/Hematology - Newport Beach Treatment CenterNewport Beach, California, United States, 92663 Usc Norris Oncology/Hematology - Newport BeachNewport Beach, California, United States, 92663 Uc Irvine Health - Chao Family Comprehensive Cancer CenterOrange, California, United States, 92868-3201 Uc Irvine Medical CenterOrange, California, United States, 92868-3201 Ucsf Helen Diller Family Comprehensive Cancer CenterSan Francisco, California, United States, 94143 University Of California, San Francisco Medical CenterSan Francisco, California, United States, 94143 University Of California, San FranciscoSan Francisco, California, United States, 94143|Boston, Massachusetts, United States, 02111 Tufts Medical CenterBoston, Massachusetts, United States, 02111 Massachusetts General HospitalBoston, Massachusetts, United States, 02114 Beth|Kansas City, Missouri, United States, 64132|Lake Success, New York, United States, 11042 North Shore University HospitalManhasset, New York, United States, 11030 Long Island Jewish Medical CenterNew Hyde Park, New York, United States, 11040 University Of Rochester Cancer Center PharmacyRochester, New York, United States, 14642 University Of Rochester Medical CenterRochester, New York, United States, 14642|Cleveland, Ohio, United States, 44106 University Hospitals Cleveland Medical CenterCleveland, Ohio, United States, 44106 Cleveland Clinic FoundationCleveland, Ohio, United States, 44195|Portland, Oregon, United States, 97239 Oregon Health & Science University-Research Pharmacy ServicesPortland, Oregon, United States, 97239 Oregon Health & Science UniversityPortland, Oregon, United States, 97239|Nashville, Tennessee, United States, 37203 The Sarah Cannon Research InstituteNashville, Tennessee, United States, 37203 Tristar Bone Marrow TransplantNashville, Tennessee, United States, 37203|Dallas, Texas, United States, 75246 Baylor University Medical CenterDallas, Texas, United States, 75246 Blood Cancer And Stem Cell Transplant ClinicSan Antonio, Texas, United States, 78229 Methodist Healthcare System Of San AntonioSan Antonio, Texas, United States, 78229 Methodist Hospital Investigational PharmacySan Antonio, Texas, United States, 78229|Seattle, Washington, United States, 98104 Swedish First Hill Ids PharmacySeattle, Washington, United States, 98104 Swedish Medical CenterSeattle, Washington, United States, 98122","California|Massachusetts|Missouri|New York|Ohio|Oregon|Tennessee|Texas|Washington","Australia|Austria|Belgium|Canada|China|Czechia|France|Germany|Hungary|Israel|Italy|Japan|Mexico|Poland|Romania|Spain|Sweden|United Kingdom|United States","Australia, 5000 Royal Adelaide Hospital|New South Wales St Vincent's Hospital Sydney|Royal Adelaide Hospital - Clinical Trials Pharmacy|Klinikum Wels-Grieskirchen Gmbh|Landeskrankenhaus Salzburg, Universitatsklinik Fur Innere Medizin Iii Der Pmu|Az Sint-Jan Brugge - Oostende Av|Manitoba Health Sciences Centre|Ontario Sunnybrook Research Institute|Quebec Ciusss De L'Est-De-L'Ile-De- MontrÃ©al - HÃ´pital Maisonneuve-Rosemont|Anhui The First Affiliated Hospital Of Ustc, Anhui Province Hospital|Fujian Fujian Medical University Union Hospital|Guangdong Guangdong Provincial People's Hospital|Hebei Hebei Yanda Lu Daopei Hospital|Henan Henan Cancer Hostipal|Hospital, Sichuan University|Hubei Tongji Hospital, Tongji Medical College, Huazhong University Of Science & Technology/Cancer Center|Jiangsu Jiangsu Province Hospital|Ruijin Hospital Affiliated To Shanghai Jiaotong University School Of Medicine|Shandong Affiliated Hospital Of Qingdao University/Hematology Department|Shanghai Shanghai General Hospital|Shannxi The First Affiliated Hospital Of Xi'An Jiaotong University|Tianjin Institute Of Hematology And Blood Diseases Hospital, Chinese Academy Of Medical Sciences|Zhejiang The First Affiliated Hospital College Of Medicine, Zhejiang University|Interni Hematologicka A Onkologicka Klinika, Fakultni Nemocnice Brno|Chu Henri Mondor|North Rhine Westphalia UniversitÃ¤tsklinikum KÃ¶ln|North-Rhine-Westphalia Universitaetsklinikum Muenster|Universitaetsklinikum Hamburg-Eppendorf|Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Klinika, Hematologia Tanszek|Deaconess Medical Center|Rambam Health Care Campus|An Sod Farmacia-Dipt Dei Servizi -Aou Ospedali Riuniti Umberto I, G.M. Lancisi, G. Salesi|Ancona Aou Ospedali Riuniti Umberto I, G.M. Lancisi, G. Salesi, Clinica Di Ematologia|Azienda Ospedaliero Universitaria Di Bologna Policlinico S.Orsola Malpighi|Fc Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori|Fe A.O.U. Di Ferrara- Arcispedale Sant'Anna,|Pu Ao Ospedali Riuniti Marche Nord - Presidio Ospedaliero San Salvatore Di Pesaro -|Rm Azienda Ospedaliero Universitaria Policlinico Umberto I|Si Azienda Ospedaliera Universitaria Senese.|Aichi Japanese Red Cross Nagoya Daini Hospital|Akita University Hospital|Fukui University Of Fukui Hospital|Gunma Gunma University Hospital|Hyogo Kobe University Hospital|Kanagawa Yokohama City University Medical Center|Miyagi Tohoku University Hospital|Osaka Osaka City University Hospital|Shizuoka Shizuoka Cancer Center|Tokyo National Hospital Organization Disaster Medical Center|Hospital General De MÃ©xico Dr. Eduardo Liceaga|MÃ©x Instituto Nacional De CancerologÃ­a|Klinika Hematologii I Transplantologii Uniwersyteckie Centrum Kliniczne|Cluj Institutul Oncologic 'Prof. Dr. Ion Chiricuta'|Dolj Spitalul Clinic Municipal Filantropia Craiova, Sectia Clinica Hematologie|Spitalul Universitar De Urgenta Militar Central \"Dr. Carol Davila\" Bucuresti|Hospital Del Mar|Sektionen For Hematologi Och Koagulation|, Surrey The Royal Marsden Nhs Foundation Trust|, West Midlands University Hospitals Birmingham Nhs Foundation Trust|Barts Health Nhs Trust|Keck Hospital Of Usc|Tufts Medical Center Investigational Pharmacy|Midamerica Division, Inc., C/O Research Medical Center|Northwell Health/Monter Cancer Center|Taussig Cancer Center Investigational Pharmacy|Ohsu Center For Health And Healing|Centennial Medical Center|Baylor Scott And White Research Institute|Swedish Cancer Institute",{"$nulls":3},"Pfizer CT.gov Call Center","2019-10-10","2020-05-25T16:39:39.432","2020-05-26T17:10:42.972","NCT03416179"]
["5ecbf4cb11702c1b1b916bd0","NCT03416179","2019-10-15","Pfizer","PFE","Recruiting","A Study Evaluating Intensive Chemotherapy With or Without Glasdegib or Azacitidine With or Without Glasdegib In Patients With Previously Untreated Acute Myeloid Leukemia (BRIGHT AML1019)","Glasdegib|Cytarabine|Daunorubicin|Azacitidine","Hh Inhibitor|DNA Polymerase Inhibitor|Nucleic Acid Synthesis Inhibitor|TOP2 Inhibitor|DNA Mtase Inhibitor","Unknown",null,"Unknown",null,"Phase 3",4,720,"Anticipated","2018-04-20","2021-06-13","OS","Overall Survival",{"$nulls":3},"Glasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).\n\nGlasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).","Two separate registration trials conducted under one protocol number are proposed to adequately and independently evaluate the addition of glasdegib in intensive and non-intensive chemotherapy populations. Each study will have an experimental treatment arm and a placebo arm. Endpoints are the same for each study except where specifically indicated.\n\nAssignment to the Intensive Study or the Non-Intensive Study will be made by the Investigator based on the 2017 European LeukemiaNet (ELN) recommendations.\n\nStudy B1371019 is a randomized (1:1), double-blind, multi-center, placebo controlled study of chemotherapy in combination with glasdegib versus chemotherapy in combination with placebo in adult patients with previously untreated AML.\n\nGlasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).\n\nGlasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).","A RANDOMIZED (1:1), DOUBLE-BLIND, MULTI-CENTER, PLACEBO CONTROLLED STUDY EVALUATING INTENSIVE CHEMOTHERAPY WITH OR WITHOUT GLASDEGIB (PF-04449913) OR AZACITIDINE (AZA) WITH OR WITHOUT GLASDEGIB IN PATIENTS WITH PREVIOUSLY UNTREATED ACUTE MYELOID LEUKEMIA","B1371019","Leukemia, Myeloid, Acute","Acute Leukemia|Acute Myeloid Leukemia|Myeloid Leukemia|Leukemia","Oncology Hematological","Oncology","Experimental|Placebo Comparator","Arm A (Intensive Study)|Arm B (Intensive Study)|Arm A (Non-intensive study)|Arm B (Non-intensive study)","Glasdegib + '7+3' Induction(s)|Placebo + '7+3' Induction(s)|Glasdegib + azacitidine|Placebo + azacitidine","Drug|Procedure","glasdegib|daunorubicin + cytarabine|cytarabine|HSCT|Placebo|azacitidine","Daily Glasdegib (100 mg, PO), beginning on Day 1 and is to continue up to 2 years post randomization.\n\nFollowing consolidation therapy, glasdegib or placebo will be administered daily for up to 2 years after randomization or until they have minimal residual disease (MRD) negative disease, whichever comes first.\n\nDaily Glasdegib (100 mg, PO) or matching placebo will continue throughout Induction(s) and Consolidation therapies regardless of dose modifications/delays in the chemotherapy.|Consolidation with single agent cytarabine 3 g/m2 IV for adults <60 years and 1 g/m2 for adults 60 years over 3 BID on Days 1, 3, and 5, every 28 days for up to 4 cycles or alternative single agent cytarabine consolidation schedules may be used per local prescribing information.|If required, and done per standard of care post Induction(s).|Azacitidine (75 mg/m2, SC or IV) daily for 7 days, in 28 day cycles for as long as they do not meet the criteria for disease progression, unacceptable toxicity, consent withdrawal, or death.|Matching placebo (PO) is to be administered by mouth daily beginning on Day 1 of chemotherapy and will continue if subjects demonstrate reasonable evidence of clinical benefit and do not meet the criteria for progression regardless of any delays/modifications in the chemotherapy treatment. Subjects will continue placebo until disease progression, unacceptable toxicity, consent withdrawal, or death, whichever comes first.","PF-04449913","Arm A (Intensive Study)|Arm B (Intensive Study)|Arm A (Non-intensive study)|Arm B (Non-intensive study)","\n\nSubjects must meet all of the following inclusion criteria to be eligible for enrollment into the Intensive and Non Intensive study (unless where indicated):\n\n 1.  Subjects with untreated AML according to the World Health Organization (WHO) 2016 Classification2, including those with: * AML arising from MDS or another antecedent hematologic disease (AHD).\n      * AML after previous cytotoxic therapy or radiation (secondary AML).\n     \n     \n 2.  18 years of age (In Japan, 20 years of age).\n 3.  Adequate Organ Function as defined by the following: * Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) 3 x upper limit of normal (ULN), excluding subjects with liver function abnormalities due to underlying malignancy.\n      * Total serum bilirubin 2 x ULN (except subjects with documented Gilbert's syndrome).\n      * Estimated creatinine clearance 30 mL/min as calculated using the standard method for the institution.\n     \n     \n 4.  QTc interval 470 msec using the Fridericia correction (QTcF).\n 5.  All anti cancer treatments (unless specified) should be discontinued 2 weeks from study entry, for example: targeted chemotherapy, radiotherapy, investigational agents, hormones, anagrelide or cytokines. * For control of rapidly progressing leukemia, all trans retinoic acid (ATRA), hydroxyurea, and/or leukopheresis may be used before and for up to 1 week after the first dose of glasdegib.\n     \n     \n 6.  Serum or urine pregnancy test (for female subjects of childbearing potential) with a minimum sensitivity of 25 IU/L or equivalent units of human chorionic gonadotropin (hCG) negative at screening.\n 7.  Male and female subjects of childbearing potential and at risk for pregnancy must agree to use at least one highly effective method of contraception throughout the study and for 180 days after the last dose of azacitidine, cytarabine, or daunorubicin; and the last dose of glasdegib or placebo, whichever occurs later.\n 8.  Female subjects of non childbearing potential must meet at least 1 of the following criteria: 1. Have undergone a documented hysterectomy and/or bilateral oophorectomy;\n      2. Have medically confirmed ovarian failure; or\n      3. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; status may be confirmed by having a serum follicle stimulating hormone (FSH) level confirming the postmenopausal state.\n     \n     All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential.\n     \n     \n 9.  Consent to a saliva sample collection for a germline comparator, unless prohibited by local regulations or ethics committee (EC) decision.\n 10. Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.\n 11. Subjects who are willing and able to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures (including bone marrow [BM] assessments).\n\n","\n\nSubjects with any of the following characteristics/conditions will not be included in the study:\n\n 1.  Acute Promyelocytic Leukemia (APL) and APLwith PML RARA, subjects (WHO 2016 classification).\n 2.  AML with BCR ABL1 or t(9;22)(q34;q11.2) as a sole abnormality. * Complex genetics may include t(9;22) cytogenetic translocation.\n     \n     \n 3.  Subjects with known active CNS leukemia.\n 4.  Participation in other clinical studies involving other investigational drug(s) (Phases 1 4) within 4 weeks prior study entry and/or during study participation.\n 5.  Subjects known to be refractory to platelet or packed red cell transfusions per Institutional Guidelines, or a patient who refuses blood product support.\n 6.  Subjects with another active malignancy on treatment with the exception of basal cell carcinoma, non melanoma skin cancer, cervical carcinoma in situ. Other prior or concurrent malignancies will be considered on a case by case basis.\n 7.  Any one of the following ongoing or in the previous 6 months: myocardial infarction, congenital long QT syndrome, Torsades de pointes, symptomatic arrhythmias (including sustained ventricular tachyarrhythmia), right or left bundle branch block and bifascicular block, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (CHF New York Heart Association class III or IV), cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism; as well as bradycardia defined as <50 bpms.\n 8.  Subjects with an active, life threatening or clinically significant uncontrolled systemic infection not related to AML.\n 9.  Subjects with left ventricular ejection fraction (LVEF) <50% are excluded from the Intensive Chemotherapy Study only.\n 10. Cumulative anthracycline dose equivalent of 550 mg/m2 of daunorubicin for the Intensive Chemotherapy Study only.\n 11. Known malabsorption syndrome or other condition that may significantly impair absorption of study medication in the investigator's judgment (eg, gastrectomy, lap band, Crohn's disease) and inability or unwillingness to swallow tablets or capsules.\n 12. Current use or anticipated requirement for drugs that are known strong CYP3A4/5 inducers.\n 13. Concurrent administration of herbal preparations.\n 14. Major surgery or radiation within 4 weeks of starting study treatment.\n 15. Documented or suspected hypersensitivity to any one of the following: * For subjects assigned to intensive chemotherapy, documented or suspected hypersensitivity to cytarabine (not including drug fever or exanthema, including known cerebellar side effects) or daunorubicin.\n      * For subjects assigned to non intensive chemotherapy, documented or suspected hypersensitivity to azacitidine or mannitol.\n     \n     \n 16. Known active drug or alcohol abuse.\n 17. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.\n 18. Pregnant females or breastfeeding female subjects.\n 19. Known recent or active suicidal ideation or behavior.\n 20. Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.","FSH",null,"Protein","Ovary","Actual","2018-01-31","Actual","Anticipated","2025-07-22","Anticipated","2019-10-01","2017-12-21","2018-01-23","2019-10-14","Yes","glasdegib;\nuntreated;\nHedgehog Inhibitor","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"All",null,"No","Yes\nPfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",null,"URL: https://pmiform.com/clinical-trial-info-request?StudyID=B1371019 [https://pmiform.com/clinical-trial-info-request?StudyID=B1371019] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To obtain contact information for a study center near you, click here.",null,"Yes","No",{"$nulls":17},"2017-002822-19|BRIGHT|BRIGHT AML1019","EudraCT Number|Alias Study Number","Overall survival","5 years after last subject randomized",null,"Fatigue score measured by the MD Anderson Symptom Inventory (MDASI)-AML/MDS questionnaire|Rate of Complete Remission (CR) (including CR with minimal residual disease (MRD)-negative as assessed by multiparametric flow cytometry)|Duration of response (defined as CR [includes CR-MRD negative]/CRi or CR/CRh as appropriate)|Time to response (CR[includes CR-MRD negative)]/CR with partial hematologic rcovery (CRh) as appropriate)|Event-free Survival|Patient Reported Outcomes (PROs) as measured by the M.D. Anderson Symptom Inventory AML/MDS Module (MDASI-AML/MDS)|Adverse events as graded by NCI CTCAE v4.03|Laboratory abnormalities as graded by NCI CTCAE v4.03|For the intensive study, the plasma trough concentration (Ctrough) will be analyzed|QTc interval|PROs as measured by Patient Global Impression of Change (PGIC)|Patient Reported Outcomes (PROs) as measured by EuroQoL 5 Dimension questionnaire 5-Level version (EQ-5D-5L)|Patient Reported Outcomes (PROs) as measured by Patient Global Impression of Symptoms (PGIS)|Complete Remission with incomplete hematologic recovery (CRi)|Rate of morphological leukemia-free state (MLFS)|Rate of Partial Remission (PR)|Rate of Complete Remission with partial hematological recovery (CRh) for the Non-intensive study only only|Minimum Observed Plasma Trough Concentratrion of glasdegib in the Intensive Study|Minimum Observed Plasma Trough Concentration of glasdegib in the Non-intensive study","Scale is from 0-10 where 0 is not present and 10 is as bad as you can image.|Response as defined by the 2017 European LeukemiaNet (ELN) recommendations.|5 years after last subject randomized, consent withdrawal, or death|Measurement Scale from 0-10.|PK samples taken on Induction(s) Day 1 (1 and 4 hours post induction); Induction(s) Day 10 (pre-dose, 1 and 4 hours post dose); Day 1 of each Consolidation cycle (pre-dose, 1 and 4 hours post dose)|One question asking for description of leukemia symptoms.|Series of questions that ask for information that best describes health.|One question asking for information regarding leukemia symptoms.|Its the minimum trough concentration in plasma of glasdegib following multiple daily dosing to steady state.|It is the minimum trough concentration in plasma of glasdegib following multiple daily dosing to steady state.","5 years after last subject randomized, consent withdrawal, or death|2 years after last dose of study therapy|5 years after last patient randomized, withdrawal, or death|5 years after last subject randomized, withdrawal, or death|Day 10 of Induction Cycle and Day 1 of each Consolidation Cycle|Cycle 1 Day 15 and Cycles 2 and 3 on Day 1","ClinicalTrials.gov_Inquiries@pfizer.com","Pfizer CT.gov Call Center","1-800-718-1021","Adelaide, South|Darlinghurst, New South Wales, Australia, 2010 St George HospitalKogarah, New South Wales, Australia, 2217|Wels, Upper|Salzburg, Austria, 5020 Uniklinikum Salzburg, Landeskrankenhaus SalzburgSalzburg, Austria, 5020 Klinikum Wels-Grieskirchen GmbhWels, Austria, 4600 Sozialmedizinisches Zentrum Sud.Wien, Austria, 1100 Krankenhaus Hietzing Mit Neurologischem Zentrum RosenhugelWien, Austria, 1130|Brugge, Belgium, B-8000 Az Sint-Jan Brugge-Oostende AvBrugge, Belgium, B-8000 Universitaire Ziekenhuizen Brussel (Uz Brussel)Brussels, Belgium, B-1090 Universitaire Ziekenhuizen BrusselBrussels, Belgium, B-1090 Universitaire Ziekenhuizen LeuvenLeuven, Belgium, B-3000|Winnipeg, Manitoba, Canada, R3A 1R9 Cancercare ManitobaWinnipeg, Manitoba, Canada, R3E 0V9|Toronto, Ontario, Canada, M4N 3M5 Princess Margaret Cancer CentreToronto, Ontario, Canada, M5G 2M9|Montreal, Quebec, Canada, H1T 2M4|Hefei, Anhui, China, 230001 Anhui Provincial HospitalHefei, Anhui, China, 230071|Fuzhou, Fujian, China, 350001|Guangzhou, Guangdong, China, 510080 Guangdong Second Provincial General HospitalGuangzhou, Guangdong, China, 510317|Langfang, Hebei, China, 065201|Zhengzhou, Henan, China, 450008|Chengdu, Sichuan, China, 610041|Wuhan, Hubei, China, 430030|Nanjing, Jiangsu, China, 210029|Shanghai, China, 200025|Qingdao, Shandong, China, 266071|Shanghai, Shanghai, China, 200080|Xi'An, Shannxi, China, 710061|Tianjin, Tianjin, China, 300020|Hangzhou, Zhejiang, China, 310003|Brno, Czechia, 100 34 Nemocnicni LekarnaBrno, Czechia, 625 00 Ustavni LekarnaOstrava - Poruba, Czechia, 708 52 Klinika HematoonkologieOstrava-Poruba, Czechia, 708 52 InternÃ­ HematologickÃ¡ Klinika, Fakultni Nemocnice KrÃ¡lovskÃ© VinohradyPraha 10, Czechia, 100 34 Ãšstavni LÃ©kÃ¡rnaPraha 10, Czechia, 100 34|Creteil, France, 94010 Chu Henri MondorCrÃ©teil, France, 94010 Chu De NantesNantes Cedex 1, France, 44093 Chu De Nantes Hotel DieuNantes Cedex, France, 44093 Hopital Saint LouisParis, France, 75010 Centre Hospitalier Lyon Sud - Service D'HematologiePierre Benite Cedex, France, 69495 Centre Hospitalier Lyon Sud -Unite De Pharmacie Clinique OncologiquePierre Benite Cedex, France, 69495 Institut Gustave RoussyVillejuif Cedex, France, 94805|Koeln, North Rhine Westphalia, Germany, 50937|Muenster, North-Rhine-Westphalia, Germany, 48149|Hamburg, Germany, 20246 Medizinische Hochschule HannoverHannover, Germany, 30625 UniversitÃ¤tsklinikum KÃ¶lnKoeln, Germany, 50937 Philipps-Universitaet MarburgMarburg, Germany, 35032|Debrecen, Hungary, 4032 Debreceni Egyetem Klinikai Kozpont Belgyogyaszati KlinikaDebrecen, Hungary, 4032 Petz AladÃ¡r Megyei OktatÃ³ KÃ³rhÃ¡z, GyÃ³gyszerÃ©szeti OsztÃ¡lyGyÅ‘r, Hungary, 9024 Petz AladÃ¡r Megyei OktatÃ³ KÃ³rhÃ¡z, Ii. BelgyÃ³gyÃ¡szat- HematolÃ³giai OsztÃ¡lyGyÅ‘r, Hungary, 9024 Somogy Megyei Kaposi Mor Oktato KorhazKaposvar, Hungary, 7400 Szabolcs-Szatmar Bereg Megyei Korhazak Es Egyetemi Oktatokorhaz, Josa Andras Korhaz, HematologiaNyiregyhaza, Hungary, 4400 Szabolcs-Szatmar Bereg Megyei Korhazak Es Egyetemi Oktatokorhaz, Josa Andras Korhaz,Nyiregyhaza, Hungary, 4400|Boston, Massachusetts, United States, 02215|Haifa, Israel, 3109601 Shaare Zedek Medical CenterJerusalem, Israel, 9103102 Hadassah Medical Center (Ein Kerem)Jerusalem, Israel, 91120 Hemato-Oncology Ambulatory ServicePetah Tikva, Israel, 4941492 Hematology Division - Oncology PharmacyPetah Tikva, Israel, 4941492 Rabin Medical Center, Beilinson HospitalPetah Tikva, Israel, 4941492 Tel-Aviv Sourasky Medical CenterTel Aviv, Israel, 6423906|Torette Di Ancona, An, Italy, 60126|Torrette Di Ancona, Ancona, Italy, 60126|Bologna, Italy, 40138 Azienda Ospedaliera Universitaria SeneseSiena, Italy, 53100|Meldola, Fc, Italy, 47014|Cona, Ferrara, Fe, Italy, 44124 Farmacia OspedalieraFerrara, Fe, Italy, 44121|Pesaro, Pu, Italy, 61122|Roma, Rm, Italy, 00161|Siena, Si, Italy, 53100|Nagoya, Aichi, Japan, 466-8650|Akita, Japan, 010-8543 Kyushu University HospitalFukuoka, Japan, 812-8582 National Hospital Organization Kumamoto Medical Center[Active, Not Recruiting]Kumamoto, Japan, 860-0008 Nagasaki University HospitalNagasaki, Japan, 852-8501 Tokyo Medical University HospitalTokyo, Japan, 160-0023 Korea, Republic Of, Jeollabuk-Do Chonbuk National University HospitalJeonju-Si, Jeollabuk-Do, Korea, Republic Of, 54907 Korea, Republic Of, Jeollanam-Do Chonnam National University Hwasun HospitalHwasun-Gun, Jeollanam-Do, Korea, Republic Of, 58128 Korea, Republic Of Department Of Pharmacy, Inje University Busan Paik HospitalBusan, Korea, Republic Of, 47392 Inje University Busan Paik HospitalBusan, Korea, Republic Of, 47392 Clinical Trial Pharmacy, Keimyung University Dongsan HospitalDaegu, Korea, Republic Of, 42601 Keimyung University Dongsan HospitalDaegu, Korea, Republic Of, 42601 Gachon University Gil Medical CenterIncheon, Korea, Republic Of, 21565 Seoul National University HospitalSeoul, Korea, Republic Of, 03080 Clinical Trial Center, Severance Hospital, Yonsei University Health SystemSeoul, Korea, Republic Of, 03722 Severance Hospital, Yonsei University Health SystemSeoul, Korea, Republic Of, 03722 Department Of Pharmacy, Samsung Medical CenterSeoul, Korea, Republic Of, 06351 Samsung Medical CenterSeoul, Korea, Republic Of, 06351 Department Of Pharmacy, Severance Hospital, Yonsei University Health SystemSeoul, Korea, Republic Of, 06591 The Catholic University Of Korea Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591 The Catholic University Of Korea, Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591|Yoshida-Gun, Fukui, Japan, 910-1193|Maebashi, Gunma, Japan, 371-8511|Kobe-Shi, Hyogo, Japan, 650-0017|Yokohama, Kanagawa, Japan, 232-0024|Sendai, Miyagi, Japan, 980-8574|Osaka-City, Osaka, Japan, 545-8586 Kindai University HospitalOsaka-Sayama, Osaka, Japan, 589-8511|Sunto-Gun, Shizuoka, Japan, 411-8777|Tachikawa, Tokyo, Japan, 190-0014|MÃ©xico, Mexico, 06726|MÃ©xico, MÃ©x, Mexico, 14080|Gdansk, Poland, 80-214 Wwcoit Im. M. Kopernika W LodziLodz, Poland, 93-513|Cluj-Napoca, Cluj, Romania, 400124|Craiova, Dolj, Romania, 200136|Bucuresti, Romania, 010825 Spitalul Clinic Coltea, Clinica De HematologieBucuresti, Romania, 030171 Russian Federation Sbhi Cch No. 40 Hd MoscowMoscow, Russian Federation, 129301 State Budgetary Healthcare Institution Of MoscowMoscow, Russian Federation, 129301 Sbhi Nnr Nn Rch N. A. N.A. SemashkoNizhniy Novgorod, Russian Federation, 603126 State Budgetary Institution Of Ryazan Region 'Regional Clinical Hospital' (Sbi Rr Rch)Ryazan, Russian Federation, 390039 Fsbi Russrhti Fmba Of|Barcelona, Spain, 08003 Hospital De La Santa Creu I Sant PauBarcelona, Spain, 08025 Hospital Universitario Arnau De VilanovaLleida, Spain, 25198 Hospital General Universitario Gregorio MaranonMadrid, Spain, 28007 Hospital Universitario Ramon Y CajalMadrid, Spain, 28034 Hospital Universitario Virgen Del RocioSevilla, Spain, 41013 Hospital Universitari I Politecnic La FeValencia, Spain, 46026|Goteborg, Sweden, 413 45 Apl, Apl Sahlgrenska, Kliniska ProvningarGoteborg, Sweden, 413 46 Apoex VnOrebro, Sweden, 701 85 Universitetssjukhuset OrebroOrebro, Sweden, 701 85 Apoex Ab Nks, Kliniska ProvningarSolna, Sweden, 171 64 Karolinska Universitetssjukhuset HuddingeStockholm, Sweden, 141 86 Taiwan National Cheng Kung University HospitalTainan, Taiwan, 704 National Taiwan University HospitalTaipei, Taiwan, 100 Department Of Clinical Trial Pharmacy, Taipei Veterans General HospitalTaipei, Taiwan, 11217 Taipei Veterans General HospitalTaipei, Taiwan, 11217 Division Of Pharmacy, Koo Foundation Sun Yat-Sen Cancer CenterTaipei, Taiwan, 112 Koo Foundation Sun Yat-Sen Cancer CenterTaipei, Taiwan, 112 Chang Gung Memorial Hospital-Linkou BranchTaoyuan City, Taiwan, 333 Chemotherapy Pharmacy, Chang Gung Memorial Hospital-Linkou BranchTaoyuan City, Taiwan, 333|Sutton, Surrey, United Kingdom, Sm2 5Pt|Birmingham, West Midlands, United Kingdom, B15 2Th University Hospitals Birmingham Nhs Foundation TrustBirmingham, West Midlands, United Kingdom, B30 3Hg|London, United Kingdom, Ec1A 7Be Imperial College Healthcare Nhs TrustLondon, United Kingdom, W12 0Hs|Los Angeles, California, United States, 90033 Lac+Usc Medical CenterLos Angeles, California, United States, 90033 Usc/Norris Comprehensive Cancer Center / Investigational Drug ServicesLos Angeles, California, United States, 90033 Usc/Norris Comprehensive Cancer CenterLos Angeles, California, United States, 90033 Rrmc - UclaLos Angeles, California, United States, 90095 Ucla Department Of MedicineLos Angeles, California, United States, 90095 Ucla Drug Information/Investigational DrugsLos Angeles, California, United States, 90095 Ucla Hematology/Oncology ClinicLos Angeles, California, United States, 90095 Ucla Ronald Reagan Medical CenterLos Angeles, California, United States, 90095 Keck Medicine Of Usc Norris Oncology/Hematology - Newport Beach Treatment CenterNewport Beach, California, United States, 92663 Usc Norris Oncology/Hematology - Newport BeachNewport Beach, California, United States, 92663 Uc Irvine Health - Chao Family Comprehensive Cancer CenterOrange, California, United States, 92868-3201 Uc Irvine Medical CenterOrange, California, United States, 92868-3201 Ucsf Helen Diller Family Comprehensive Cancer CenterSan Francisco, California, United States, 94143 University Of California, San Francisco Medical CenterSan Francisco, California, United States, 94143 University Of California, San FranciscoSan Francisco, California, United States, 94143 Ucla Hematology/Oncology - Westlake VillageWestlake Village, California, United States, 91361|Boston, Massachusetts, United States, 02111 Tufts Medical CenterBoston, Massachusetts, United States, 02111 Massachusetts General HospitalBoston, Massachusetts, United States, 02114 Beth|Kansas City, Missouri, United States, 64132|Lake Success, New York, United States, 11042 North Shore University HospitalManhasset, New York, United States, 11030 Long Island Jewish Medical CenterNew Hyde Park, New York, United States, 11040 University Of Rochester Cancer Center PharmacyRochester, New York, United States, 14642 University Of Rochester Medical CenterRochester, New York, United States, 14642|Cleveland, Ohio, United States, 44106 University Hospitals Cleveland Medical CenterCleveland, Ohio, United States, 44106 Cleveland Clinic FoundationCleveland, Ohio, United States, 44195|Portland, Oregon, United States, 97239 Oregon Health & Science University-Research Pharmacy ServicesPortland, Oregon, United States, 97239 Oregon Health & Science UniversityPortland, Oregon, United States, 97239|Nashville, Tennessee, United States, 37203 The Sarah Cannon Research InstituteNashville, Tennessee, United States, 37203 Tristar Bone Marrow TransplantNashville, Tennessee, United States, 37203|Dallas, Texas, United States, 75246 Baylor University Medical CenterDallas, Texas, United States, 75246 Blood Cancer And Stem Cell Transplant ClinicSan Antonio, Texas, United States, 78229 Methodist Healthcare System Of San AntonioSan Antonio, Texas, United States, 78229 Methodist Hospital Investigational PharmacySan Antonio, Texas, United States, 78229|Seattle, Washington, United States, 98104 Swedish First Hill Ids PharmacySeattle, Washington, United States, 98104 Swedish Medical CenterSeattle, Washington, United States, 98122","California|Massachusetts|Missouri|New York|Ohio|Oregon|Tennessee|Texas|Washington","Australia|Austria|Belgium|Canada|China|Czechia|France|Germany|Hungary|Israel|Italy|Japan|Mexico|Poland|Romania|Spain|Sweden|United Kingdom|United States","Australia, 5000 Royal Adelaide Hospital|New South Wales St Vincent's Hospital Sydney|Royal Adelaide Hospital - Clinical Trials Pharmacy|Klinikum Wels-Grieskirchen Gmbh|Landeskrankenhaus Salzburg, Universitatsklinik Fur Innere Medizin Iii Der Pmu|Az Sint-Jan Brugge - Oostende Av|Manitoba Health Sciences Centre|Ontario Sunnybrook Research Institute|Quebec Ciusss De L'Est-De-L'Ile-De- MontrÃ©al - HÃ´pital Maisonneuve-Rosemont|Anhui The First Affiliated Hospital Of Ustc, Anhui Province Hospital|Fujian Fujian Medical University Union Hospital|Guangdong Guangdong Provincial People's Hospital|Hebei Hebei Yanda Lu Daopei Hospital|Henan Henan Cancer Hostipal|Hospital, Sichuan University|Hubei Tongji Hospital, Tongji Medical College, Huazhong University Of Science & Technology/Cancer Center|Jiangsu Jiangsu Province Hospital|Ruijin Hospital Affiliated To Shanghai Jiaotong University School Of Medicine|Shandong Affiliated Hospital Of Qingdao University/Hematology Department|Shanghai Shanghai General Hospital|Shannxi The First Affiliated Hospital Of Xi'An Jiaotong University|Tianjin Institute Of Hematology And Blood Diseases Hospital, Chinese Academy Of Medical Sciences|Zhejiang The First Affiliated Hospital College Of Medicine, Zhejiang University|Interni Hematologicka A Onkologicka Klinika, Fakultni Nemocnice Brno|Chu Henri Mondor|North Rhine Westphalia UniversitÃ¤tsklinikum KÃ¶ln|North-Rhine-Westphalia Universitaetsklinikum Muenster|Universitaetsklinikum Hamburg-Eppendorf|Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Klinika, Hematologia Tanszek|Deaconess Medical Center|Rambam Health Care Campus|An Sod Farmacia-Dipt Dei Servizi -Aou Ospedali Riuniti Umberto I, G.M. Lancisi, G. Salesi|Ancona Aou Ospedali Riuniti Umberto I, G.M. Lancisi, G. Salesi, Clinica Di Ematologia|Azienda Ospedaliero Universitaria Di Bologna Policlinico S.Orsola Malpighi|Fc Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori|Fe A.O.U. Di Ferrara- Arcispedale Sant'Anna,|Pu Ao Ospedali Riuniti Marche Nord - Presidio Ospedaliero San Salvatore Di Pesaro -|Rm Azienda Ospedaliero Universitaria Policlinico Umberto I|Si Azienda Ospedaliera Universitaria Senese.|Aichi Japanese Red Cross Nagoya Daini Hospital|Akita University Hospital|Fukui University Of Fukui Hospital|Gunma Gunma University Hospital|Hyogo Kobe University Hospital|Kanagawa Yokohama City University Medical Center|Miyagi Tohoku University Hospital|Osaka Osaka City University Hospital|Shizuoka Shizuoka Cancer Center|Tokyo National Hospital Organization Disaster Medical Center|Hospital General De MÃ©xico Dr. Eduardo Liceaga|MÃ©x Instituto Nacional De CancerologÃ­a|Klinika Hematologii I Transplantologii Uniwersyteckie Centrum Kliniczne|Cluj Institutul Oncologic 'Prof. Dr. Ion Chiricuta'|Dolj Spitalul Clinic Municipal Filantropia Craiova, Sectia Clinica Hematologie|Spitalul Universitar De Urgenta Militar Central \"Dr. Carol Davila\" Bucuresti|Hospital Del Mar|Sektionen For Hematologi Och Koagulation|, Surrey The Royal Marsden Nhs Foundation Trust|, West Midlands University Hospitals Birmingham Nhs Foundation Trust|Barts Health Nhs Trust|Keck Hospital Of Usc|Tufts Medical Center Investigational Pharmacy|Midamerica Division, Inc., C/O Research Medical Center|Northwell Health/Monter Cancer Center|Taussig Cancer Center Investigational Pharmacy|Ohsu Center For Health And Healing|Centennial Medical Center|Baylor Scott And White Research Institute|Swedish Cancer Institute",{"$nulls":3},"Pfizer CT.gov Call Center","2019-10-14","2020-05-25T16:39:39.457","2020-05-26T17:10:42.972","NCT03416179"]
["5ecbf4cbe2561b1b11905ebe","NCT03416179","2019-10-22","Pfizer","PFE","Recruiting","A Study Evaluating Intensive Chemotherapy With or Without Glasdegib or Azacitidine With or Without Glasdegib In Patients With Previously Untreated Acute Myeloid Leukemia (BRIGHT AML1019)","Glasdegib|Cytarabine|Daunorubicin|Azacitidine","Hh Inhibitor|DNA Polymerase Inhibitor|Nucleic Acid Synthesis Inhibitor|TOP2 Inhibitor|DNA Mtase Inhibitor","Unknown",null,"Unknown",null,"Phase 3",4,720,"Anticipated","2018-04-20","2021-06-13","OS","Overall Survival",{"$nulls":3},"Glasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).\n\nGlasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).","Two separate registration trials conducted under one protocol number are proposed to adequately and independently evaluate the addition of glasdegib in intensive and non-intensive chemotherapy populations. Each study will have an experimental treatment arm and a placebo arm. Endpoints are the same for each study except where specifically indicated.\n\nAssignment to the Intensive Study or the Non-Intensive Study will be made by the Investigator based on the 2017 European LeukemiaNet (ELN) recommendations.\n\nStudy B1371019 is a randomized (1:1), double-blind, multi-center, placebo controlled study of chemotherapy in combination with glasdegib versus chemotherapy in combination with placebo in adult patients with previously untreated AML.\n\nGlasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).\n\nGlasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).","A RANDOMIZED (1:1), DOUBLE-BLIND, MULTI-CENTER, PLACEBO CONTROLLED STUDY EVALUATING INTENSIVE CHEMOTHERAPY WITH OR WITHOUT GLASDEGIB (PF-04449913) OR AZACITIDINE (AZA) WITH OR WITHOUT GLASDEGIB IN PATIENTS WITH PREVIOUSLY UNTREATED ACUTE MYELOID LEUKEMIA","B1371019","Leukemia, Myeloid, Acute","Acute Leukemia|Acute Myeloid Leukemia|Myeloid Leukemia|Leukemia","Oncology Hematological","Oncology","Experimental|Placebo Comparator","Arm A (Intensive Study)|Arm B (Intensive Study)|Arm A (Non-intensive study)|Arm B (Non-intensive study)","Glasdegib + '7+3' Induction(s)|Placebo + '7+3' Induction(s)|Glasdegib + azacitidine|Placebo + azacitidine","Drug|Procedure","glasdegib|daunorubicin + cytarabine|cytarabine|HSCT|Placebo|azacitidine","Daily Glasdegib (100 mg, PO), beginning on Day 1 and is to continue up to 2 years post randomization.\n\nFollowing consolidation therapy, glasdegib or placebo will be administered daily for up to 2 years after randomization or until they have minimal residual disease (MRD) negative disease, whichever comes first.\n\nDaily Glasdegib (100 mg, PO) or matching placebo will continue throughout Induction(s) and Consolidation therapies regardless of dose modifications/delays in the chemotherapy.|Consolidation with single agent cytarabine 3 g/m2 IV for adults <60 years and 1 g/m2 for adults 60 years over 3 BID on Days 1, 3, and 5, every 28 days for up to 4 cycles or alternative single agent cytarabine consolidation schedules may be used per local prescribing information.|If required, and done per standard of care post Induction(s).|Azacitidine (75 mg/m2, SC or IV) daily for 7 days, in 28 day cycles for as long as they do not meet the criteria for disease progression, unacceptable toxicity, consent withdrawal, or death.|Matching placebo (PO) is to be administered by mouth daily beginning on Day 1 of chemotherapy and will continue if subjects demonstrate reasonable evidence of clinical benefit and do not meet the criteria for progression regardless of any delays/modifications in the chemotherapy treatment. Subjects will continue placebo until disease progression, unacceptable toxicity, consent withdrawal, or death, whichever comes first.","PF-04449913","Arm A (Intensive Study)|Arm B (Intensive Study)|Arm A (Non-intensive study)|Arm B (Non-intensive study)","\n\nSubjects must meet all of the following inclusion criteria to be eligible for enrollment into the Intensive and Non Intensive study (unless where indicated):\n\n 1.  Subjects with untreated AML according to the World Health Organization (WHO) 2016 Classification2, including those with: * AML arising from MDS or another antecedent hematologic disease (AHD).\n      * AML after previous cytotoxic therapy or radiation (secondary AML).\n     \n     \n 2.  18 years of age (In Japan, 20 years of age).\n 3.  Adequate Organ Function as defined by the following: * Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) 3 x upper limit of normal (ULN), excluding subjects with liver function abnormalities due to underlying malignancy.\n      * Total serum bilirubin 2 x ULN (except subjects with documented Gilbert's syndrome).\n      * Estimated creatinine clearance 30 mL/min as calculated using the standard method for the institution.\n     \n     \n 4.  QTc interval 470 msec using the Fridericia correction (QTcF).\n 5.  All anti cancer treatments (unless specified) should be discontinued 2 weeks from study entry, for example: targeted chemotherapy, radiotherapy, investigational agents, hormones, anagrelide or cytokines. * For control of rapidly progressing leukemia, all trans retinoic acid (ATRA), hydroxyurea, and/or leukopheresis may be used before and for up to 1 week after the first dose of glasdegib.\n     \n     \n 6.  Serum or urine pregnancy test (for female subjects of childbearing potential) with a minimum sensitivity of 25 IU/L or equivalent units of human chorionic gonadotropin (hCG) negative at screening.\n 7.  Male and female subjects of childbearing potential and at risk for pregnancy must agree to use at least one highly effective method of contraception throughout the study and for 180 days after the last dose of azacitidine, cytarabine, or daunorubicin; and the last dose of glasdegib or placebo, whichever occurs later.\n 8.  Female subjects of non childbearing potential must meet at least 1 of the following criteria: 1. Have undergone a documented hysterectomy and/or bilateral oophorectomy;\n      2. Have medically confirmed ovarian failure; or\n      3. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; status may be confirmed by having a serum follicle stimulating hormone (FSH) level confirming the postmenopausal state.\n     \n     All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential.\n     \n     \n 9.  Consent to a saliva sample collection for a germline comparator, unless prohibited by local regulations or ethics committee (EC) decision.\n 10. Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.\n 11. Subjects who are willing and able to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures (including bone marrow [BM] assessments).\n\n","\n\nSubjects with any of the following characteristics/conditions will not be included in the study:\n\n 1.  Acute Promyelocytic Leukemia (APL) and APLwith PML RARA, subjects (WHO 2016 classification).\n 2.  AML with BCR ABL1 or t(9;22)(q34;q11.2) as a sole abnormality. * Complex genetics may include t(9;22) cytogenetic translocation.\n     \n     \n 3.  Subjects with known active CNS leukemia.\n 4.  Participation in other clinical studies involving other investigational drug(s) (Phases 1 4) within 4 weeks prior study entry and/or during study participation.\n 5.  Subjects known to be refractory to platelet or packed red cell transfusions per Institutional Guidelines, or a patient who refuses blood product support.\n 6.  Subjects with another active malignancy on treatment with the exception of basal cell carcinoma, non melanoma skin cancer, cervical carcinoma in situ. Other prior or concurrent malignancies will be considered on a case by case basis.\n 7.  Any one of the following ongoing or in the previous 6 months: myocardial infarction, congenital long QT syndrome, Torsades de pointes, symptomatic arrhythmias (including sustained ventricular tachyarrhythmia), right or left bundle branch block and bifascicular block, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (CHF New York Heart Association class III or IV), cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism; as well as bradycardia defined as <50 bpms.\n 8.  Subjects with an active, life threatening or clinically significant uncontrolled systemic infection not related to AML.\n 9.  Subjects with left ventricular ejection fraction (LVEF) <50% are excluded from the Intensive Chemotherapy Study only.\n 10. Cumulative anthracycline dose equivalent of 550 mg/m2 of daunorubicin for the Intensive Chemotherapy Study only.\n 11. Known malabsorption syndrome or other condition that may significantly impair absorption of study medication in the investigator's judgment (eg, gastrectomy, lap band, Crohn's disease) and inability or unwillingness to swallow tablets or capsules.\n 12. Current use or anticipated requirement for drugs that are known strong CYP3A4/5 inducers.\n 13. Concurrent administration of herbal preparations.\n 14. Major surgery or radiation within 4 weeks of starting study treatment.\n 15. Documented or suspected hypersensitivity to any one of the following: * For subjects assigned to intensive chemotherapy, documented or suspected hypersensitivity to cytarabine (not including drug fever or exanthema, including known cerebellar side effects) or daunorubicin.\n      * For subjects assigned to non intensive chemotherapy, documented or suspected hypersensitivity to azacitidine or mannitol.\n     \n     \n 16. Known active drug or alcohol abuse.\n 17. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.\n 18. Pregnant females or breastfeeding female subjects.\n 19. Known recent or active suicidal ideation or behavior.\n 20. Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.","FSH",null,"Protein","Ovary","Actual","2018-01-31","Actual","Anticipated","2025-07-22","Anticipated","2019-10-01","2017-12-21","2018-01-23","2019-10-20","Yes","glasdegib;\nuntreated;\nHedgehog Inhibitor","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"All",null,"No","Yes\nPfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",null,"URL: https://pmiform.com/clinical-trial-info-request?StudyID=B1371019 [https://pmiform.com/clinical-trial-info-request?StudyID=B1371019] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To obtain contact information for a study center near you, click here.",null,"Yes","No",{"$nulls":17},"2017-002822-19|BRIGHT|BRIGHT AML1019","EudraCT Number|Alias Study Number","Overall survival","5 years after last subject randomized",null,"Fatigue score measured by the MD Anderson Symptom Inventory (MDASI)-AML/MDS questionnaire|Rate of Complete Remission (CR) (including CR with minimal residual disease (MRD)-negative as assessed by multiparametric flow cytometry)|Duration of response (defined as CR [includes CR-MRD negative]/CRi or CR/CRh as appropriate)|Time to response (CR[includes CR-MRD negative)]/CR with partial hematologic rcovery (CRh) as appropriate)|Event-free Survival|Patient Reported Outcomes (PROs) as measured by the M.D. Anderson Symptom Inventory AML/MDS Module (MDASI-AML/MDS)|Adverse events as graded by NCI CTCAE v4.03|Laboratory abnormalities as graded by NCI CTCAE v4.03|For the intensive study, the plasma trough concentration (Ctrough) will be analyzed|QTc interval|PROs as measured by Patient Global Impression of Change (PGIC)|Patient Reported Outcomes (PROs) as measured by EuroQoL 5 Dimension questionnaire 5-Level version (EQ-5D-5L)|Patient Reported Outcomes (PROs) as measured by Patient Global Impression of Symptoms (PGIS)|Complete Remission with incomplete hematologic recovery (CRi)|Rate of morphological leukemia-free state (MLFS)|Rate of Partial Remission (PR)|Rate of Complete Remission with partial hematological recovery (CRh) for the Non-intensive study only only|Minimum Observed Plasma Trough Concentratrion of glasdegib in the Intensive Study|Minimum Observed Plasma Trough Concentration of glasdegib in the Non-intensive study","Scale is from 0-10 where 0 is not present and 10 is as bad as you can image.|Response as defined by the 2017 European LeukemiaNet (ELN) recommendations.|5 years after last subject randomized, consent withdrawal, or death|Measurement Scale from 0-10.|PK samples taken on Induction(s) Day 1 (1 and 4 hours post induction); Induction(s) Day 10 (pre-dose, 1 and 4 hours post dose); Day 1 of each Consolidation cycle (pre-dose, 1 and 4 hours post dose)|One question asking for description of leukemia symptoms.|Series of questions that ask for information that best describes health.|One question asking for information regarding leukemia symptoms.|Its the minimum trough concentration in plasma of glasdegib following multiple daily dosing to steady state.|It is the minimum trough concentration in plasma of glasdegib following multiple daily dosing to steady state.","5 years after last subject randomized, consent withdrawal, or death|2 years after last dose of study therapy|5 years after last patient randomized, withdrawal, or death|5 years after last subject randomized, withdrawal, or death|Day 10 of Induction Cycle and Day 1 of each Consolidation Cycle|Cycle 1 Day 15 and Cycles 2 and 3 on Day 1","ClinicalTrials.gov_Inquiries@pfizer.com","Pfizer CT.gov Call Center","1-800-718-1021","Adelaide, South|Darlinghurst, New South Wales, Australia, 2010 St George HospitalKogarah, New South Wales, Australia, 2217|Wels, Upper|Salzburg, Austria, 5020 Uniklinikum Salzburg, Landeskrankenhaus SalzburgSalzburg, Austria, 5020 Klinikum Wels-Grieskirchen GmbhWels, Austria, 4600 Sozialmedizinisches Zentrum Sud.Wien, Austria, 1100 Krankenhaus Hietzing Mit Neurologischem Zentrum RosenhugelWien, Austria, 1130|Brugge, Belgium, B-8000 Az Sint-Jan Brugge-Oostende AvBrugge, Belgium, B-8000 Universitaire Ziekenhuizen Brussel (Uz Brussel)Brussels, Belgium, B-1090 Universitaire Ziekenhuizen BrusselBrussels, Belgium, B-1090 Universitaire Ziekenhuizen LeuvenLeuven, Belgium, B-3000|Winnipeg, Manitoba, Canada, R3A 1R9 Cancercare ManitobaWinnipeg, Manitoba, Canada, R3E 0V9|Toronto, Ontario, Canada, M4N 3M5 Princess Margaret Cancer CentreToronto, Ontario, Canada, M5G 2M9|Montreal, Quebec, Canada, H1T 2M4|Hefei, Anhui, China, 230001 Anhui Provincial HospitalHefei, Anhui, China, 230071|Fuzhou, Fujian, China, 350001|Guangzhou, Guangdong, China, 510080 Guangdong Second Provincial General HospitalGuangzhou, Guangdong, China, 510317|Langfang, Hebei, China, 065201|Zhengzhou, Henan, China, 450003 Henan Cancer HostipalZhengzhou, Henan, China, 450008|Chengdu, Sichuan, China, 610041|Wuhan, Hubei, China, 430030|Nanjing, Jiangsu, China, 210029|Shanghai, China, 200025|Qingdao, Shandong, China, 266071|Shanghai, Shanghai, China, 200080|Xi'An, Shannxi, China, 710061|Tianjin, Tianjin, China, 300020|Hangzhou, Zhejiang, China, 310003|Brno, Czechia, 100 34 Nemocnicni LekarnaBrno, Czechia, 625 00 Ustavni LekarnaOstrava - Poruba, Czechia, 708 52 Klinika HematoonkologieOstrava-Poruba, Czechia, 708 52 InternÃ­ HematologickÃ¡ Klinika, Fakultni Nemocnice KrÃ¡lovskÃ© VinohradyPraha 10, Czechia, 100 34 Ãšstavni LÃ©kÃ¡rnaPraha 10, Czechia, 100 34|Creteil, France, 94010 Chu Henri MondorCrÃ©teil, France, 94010 Chu De NantesNantes Cedex 1, France, 44093 Chu De Nantes Hotel DieuNantes Cedex, France, 44093 Hopital Saint LouisParis, France, 75010 Centre Hospitalier Lyon Sud - Service D'HematologiePierre Benite Cedex, France, 69495 Centre Hospitalier Lyon Sud -Unite De Pharmacie Clinique OncologiquePierre Benite Cedex, France, 69495 Institut Gustave RoussyVillejuif Cedex, France, 94805|Koeln, North Rhine Westphalia, Germany, 50937|Muenster, North-Rhine-Westphalia, Germany, 48149|Hamburg, Germany, 20246 Medizinische Hochschule HannoverHannover, Germany, 30625 UniversitÃ¤tsklinikum KÃ¶lnKoeln, Germany, 50937 Philipps-Universitaet MarburgMarburg, Germany, 35032|Thessaloniki, Greece, 57010|Debrecen, Hungary, 4032 Debreceni Egyetem Klinikai Kozpont Belgyogyaszati KlinikaDebrecen, Hungary, 4032 Petz AladÃ¡r Megyei OktatÃ³ KÃ³rhÃ¡z, GyÃ³gyszerÃ©szeti OsztÃ¡lyGyÅ‘r, Hungary, 9024 Petz AladÃ¡r Megyei OktatÃ³ KÃ³rhÃ¡z, Ii. BelgyÃ³gyÃ¡szat- HematolÃ³giai OsztÃ¡lyGyÅ‘r, Hungary, 9024 Somogy Megyei Kaposi Mor Oktato KorhazKaposvar, Hungary, 7400 Szabolcs-Szatmar Bereg Megyei Korhazak Es Egyetemi Oktatokorhaz, Josa Andras Korhaz, HematologiaNyiregyhaza, Hungary, 4400 Szabolcs-Szatmar Bereg Megyei Korhazak Es Egyetemi Oktatokorhaz, Josa Andras Korhaz,Nyiregyhaza, Hungary, 4400|Boston, Massachusetts, United States, 02215|Haifa, Israel, 3109601 Shaare Zedek Medical CenterJerusalem, Israel, 9103102 Hadassah Medical Center (Ein Kerem)Jerusalem, Israel, 91120 Hemato-Oncology Ambulatory ServicePetah Tikva, Israel, 4941492 Hematology Division - Oncology PharmacyPetah Tikva, Israel, 4941492 Rabin Medical Center, Beilinson HospitalPetah Tikva, Israel, 4941492 Tel-Aviv Sourasky Medical CenterTel Aviv, Israel, 6423906|Torette Di Ancona, An, Italy, 60126|Torrette Di Ancona, Ancona, Italy, 60126|Bologna, Italy, 40138 Azienda Ospedaliera Universitaria SeneseSiena, Italy, 53100|Meldola, Fc, Italy, 47014|Cona, Ferrara, Fe, Italy, 44124 Farmacia OspedalieraFerrara, Fe, Italy, 44121|Pesaro, Pu, Italy, 61122|Roma, Rm, Italy, 00161|Siena, Si, Italy, 53100|Nagoya, Aichi, Japan, 466-8650|Akita, Japan, 010-8543 Kyushu University HospitalFukuoka, Japan, 812-8582 National Hospital Organization Kumamoto Medical Center[Active, Not Recruiting]Kumamoto, Japan, 860-0008 Nagasaki University HospitalNagasaki, Japan, 852-8501 Tokyo Medical University HospitalTokyo, Japan, 160-0023 Korea, Republic Of, Jeollabuk-Do Chonbuk National University HospitalJeonju-Si, Jeollabuk-Do, Korea, Republic Of, 54907 Korea, Republic Of, Jeollanam-Do Chonnam National University Hwasun HospitalHwasun-Gun, Jeollanam-Do, Korea, Republic Of, 58128 Korea, Republic Of Department Of Pharmacy, Inje University Busan Paik HospitalBusan, Korea, Republic Of, 47392 Inje University Busan Paik HospitalBusan, Korea, Republic Of, 47392 Clinical Trial Pharmacy, Keimyung University Dongsan HospitalDaegu, Korea, Republic Of, 42601 Keimyung University Dongsan HospitalDaegu, Korea, Republic Of, 42601 Gachon University Gil Medical CenterIncheon, Korea, Republic Of, 21565 Seoul National University HospitalSeoul, Korea, Republic Of, 03080 Clinical Trial Center, Severance Hospital, Yonsei University Health SystemSeoul, Korea, Republic Of, 03722 Severance Hospital, Yonsei University Health SystemSeoul, Korea, Republic Of, 03722 Department Of Pharmacy, Samsung Medical CenterSeoul, Korea, Republic Of, 06351 Samsung Medical CenterSeoul, Korea, Republic Of, 06351 Department Of Pharmacy, Severance Hospital, Yonsei University Health SystemSeoul, Korea, Republic Of, 06591 The Catholic University Of Korea Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591 The Catholic University Of Korea, Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591|Yoshida-Gun, Fukui, Japan, 910-1193|Maebashi, Gunma, Japan, 371-8511|Kobe-Shi, Hyogo, Japan, 650-0017|Yokohama, Kanagawa, Japan, 232-0024|Sendai, Miyagi, Japan, 980-8574|Osaka-City, Osaka, Japan, 545-8586 Kindai University HospitalOsaka-Sayama, Osaka, Japan, 589-8511|Sunto-Gun, Shizuoka, Japan, 411-8777|Tachikawa, Tokyo, Japan, 190-0014|MÃ©xico, Mexico, 06726|MÃ©xico, MÃ©x, Mexico, 14080|Gdansk, Poland, 80-214 Wwcoit Im. M. Kopernika W LodziLodz, Poland, 93-513|Cluj-Napoca, Cluj, Romania, 400124|Craiova, Dolj, Romania, 200136|Bucuresti, Romania, 010825 Spitalul Clinic Coltea, Clinica De HematologieBucuresti, Romania, 030171 Russian Federation Sbhi Cch No. 40 Hd MoscowMoscow, Russian Federation, 129301 State Budgetary Healthcare Institution Of MoscowMoscow, Russian Federation, 129301 Sbhi Nnr Nn Rch N. A. N.A. SemashkoNizhniy Novgorod, Russian Federation, 603126 State Budgetary Institution Of Ryazan Region 'Regional Clinical Hospital' (Sbi Rr Rch)Ryazan, Russian Federation, 390039 Fsbi Russrhti Fmba Of|Barcelona, Spain, 08003 Hospital De La Santa Creu I Sant PauBarcelona, Spain, 08025 Hospital Universitario Arnau De VilanovaLleida, Spain, 25198 Hospital General Universitario Gregorio MaranonMadrid, Spain, 28007 Hospital Universitario Ramon Y CajalMadrid, Spain, 28034 Hospital Universitario Virgen Del RocioSevilla, Spain, 41013 Hospital Universitari I Politecnic La FeValencia, Spain, 46026|Goteborg, Sweden, 413 45 Apl, Apl Sahlgrenska, Kliniska ProvningarGoteborg, Sweden, 413 46 Apoex VnOrebro, Sweden, 701 85 Universitetssjukhuset OrebroOrebro, Sweden, 701 85 Apoex Ab Nks, Kliniska ProvningarSolna, Sweden, 171 64 Karolinska Universitetssjukhuset HuddingeStockholm, Sweden, 141 86 Taiwan National Cheng Kung University HospitalTainan, Taiwan, 704 National Taiwan University HospitalTaipei, Taiwan, 100 Department Of Clinical Trial Pharmacy, Taipei Veterans General HospitalTaipei, Taiwan, 11217 Taipei Veterans General HospitalTaipei, Taiwan, 11217 Division Of Pharmacy, Koo Foundation Sun Yat-Sen Cancer CenterTaipei, Taiwan, 112 Koo Foundation Sun Yat-Sen Cancer CenterTaipei, Taiwan, 112 Chang Gung Memorial Hospital-Linkou BranchTaoyuan City, Taiwan, 333 Chemotherapy Pharmacy, Chang Gung Memorial Hospital-Linkou BranchTaoyuan City, Taiwan, 333|Sutton, Surrey, United Kingdom, Sm2 5Pt|Birmingham, West Midlands, United Kingdom, B15 2Th University Hospitals Birmingham Nhs Foundation TrustBirmingham, West Midlands, United Kingdom, B30 3Hg|London, United Kingdom, Ec1A 7Be Imperial College Healthcare Nhs TrustLondon, United Kingdom, W12 0Hs|Los Angeles, California, United States, 90033 Lac+Usc Medical CenterLos Angeles, California, United States, 90033 Usc/Norris Comprehensive Cancer Center / Investigational Drug ServicesLos Angeles, California, United States, 90033 Usc/Norris Comprehensive Cancer CenterLos Angeles, California, United States, 90033 Rrmc - UclaLos Angeles, California, United States, 90095 Ucla Department Of MedicineLos Angeles, California, United States, 90095 Ucla Drug Information/Investigational DrugsLos Angeles, California, United States, 90095 Ucla Hematology/Oncology ClinicLos Angeles, California, United States, 90095 Ucla Ronald Reagan Medical CenterLos Angeles, California, United States, 90095 Keck Medicine Of Usc Norris Oncology/Hematology - Newport Beach Treatment CenterNewport Beach, California, United States, 92663 Usc Norris Oncology/Hematology - Newport BeachNewport Beach, California, United States, 92663 Uc Irvine Health - Chao Family Comprehensive Cancer CenterOrange, California, United States, 92868-3201 Uc Irvine Medical CenterOrange, California, United States, 92868-3201 Ucsf Helen Diller Family Comprehensive Cancer CenterSan Francisco, California, United States, 94143 University Of California, San Francisco Medical CenterSan Francisco, California, United States, 94143 University Of California, San FranciscoSan Francisco, California, United States, 94143 Ucla Hematology/Oncology - Westlake VillageWestlake Village, California, United States, 91361|Boston, Massachusetts, United States, 02111 Tufts Medical CenterBoston, Massachusetts, United States, 02111 Massachusetts General HospitalBoston, Massachusetts, United States, 02114 Beth|Kansas City, Missouri, United States, 64132|Lake Success, New York, United States, 11042 North Shore University HospitalManhasset, New York, United States, 11030 Long Island Jewish Medical CenterNew Hyde Park, New York, United States, 11040 University Of Rochester Cancer Center PharmacyRochester, New York, United States, 14642 University Of Rochester Medical CenterRochester, New York, United States, 14642|Cleveland, Ohio, United States, 44106 University Hospitals Cleveland Medical CenterCleveland, Ohio, United States, 44106 Cleveland Clinic FoundationCleveland, Ohio, United States, 44195|Portland, Oregon, United States, 97239 Oregon Health & Science University-Research Pharmacy ServicesPortland, Oregon, United States, 97239 Oregon Health & Science UniversityPortland, Oregon, United States, 97239|Nashville, Tennessee, United States, 37203 The Sarah Cannon Research InstituteNashville, Tennessee, United States, 37203 Tristar Bone Marrow TransplantNashville, Tennessee, United States, 37203|Dallas, Texas, United States, 75246 Baylor University Medical CenterDallas, Texas, United States, 75246 Blood Cancer And Stem Cell Transplant ClinicSan Antonio, Texas, United States, 78229 Methodist Healthcare System Of San AntonioSan Antonio, Texas, United States, 78229 Methodist Hospital Investigational PharmacySan Antonio, Texas, United States, 78229|Seattle, Washington, United States, 98104 Swedish First Hill Ids PharmacySeattle, Washington, United States, 98104 Swedish Medical CenterSeattle, Washington, United States, 98122","California|Massachusetts|Missouri|New York|Ohio|Oregon|Tennessee|Texas|Washington","Australia|Austria|Belgium|Canada|China|Czechia|France|Germany|Greece|Hungary|Israel|Italy|Japan|Mexico|Poland|Romania|Spain|Sweden|United Kingdom|United States","Australia, 5000 Royal Adelaide Hospital|New South Wales St Vincent's Hospital Sydney|Royal Adelaide Hospital - Clinical Trials Pharmacy|Klinikum Wels-Grieskirchen Gmbh|Landeskrankenhaus Salzburg, Universitatsklinik Fur Innere Medizin Iii Der Pmu|Az Sint-Jan Brugge - Oostende Av|Manitoba Health Sciences Centre|Ontario Sunnybrook Research Institute|Quebec Ciusss De L'Est-De-L'Ile-De- MontrÃ©al - HÃ´pital Maisonneuve-Rosemont|Anhui The First Affiliated Hospital Of Ustc, Anhui Province Hospital|Fujian Fujian Medical University Union Hospital|Guangdong Guangdong Provincial People's Hospital|Hebei Hebei Yanda Lu Daopei Hospital|Henan Henan Provincial People's Hospital/Hematology Department|Hospital, Sichuan University|Hubei Tongji Hospital, Tongji Medical College, Huazhong University Of Science & Technology/Cancer Center|Jiangsu Jiangsu Province Hospital|Ruijin Hospital Affiliated To Shanghai Jiaotong University School Of Medicine|Shandong Affiliated Hospital Of Qingdao University/Hematology Department|Shanghai Shanghai General Hospital|Shannxi The First Affiliated Hospital Of Xi'An Jiaotong University|Tianjin Institute Of Hematology And Blood Diseases Hospital, Chinese Academy Of Medical Sciences|Zhejiang The First Affiliated Hospital College Of Medicine, Zhejiang University|Interni Hematologicka A Onkologicka Klinika, Fakultni Nemocnice Brno|Chu Henri Mondor|North Rhine Westphalia UniversitÃ¤tsklinikum KÃ¶ln|North-Rhine-Westphalia Universitaetsklinikum Muenster|Universitaetsklinikum Hamburg-Eppendorf|General Hospital Of Thessaloniki|Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Klinika, Hematologia Tanszek|Deaconess Medical Center|Rambam Health Care Campus|An Sod Farmacia-Dipt Dei Servizi -Aou Ospedali Riuniti Umberto I, G.M. Lancisi, G. Salesi|Ancona Aou Ospedali Riuniti Umberto I, G.M. Lancisi, G. Salesi, Clinica Di Ematologia|Azienda Ospedaliero Universitaria Di Bologna Policlinico S.Orsola Malpighi|Fc Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori|Fe A.O.U. Di Ferrara- Arcispedale Sant'Anna,|Pu Ao Ospedali Riuniti Marche Nord - Presidio Ospedaliero San Salvatore Di Pesaro -|Rm Azienda Ospedaliero Universitaria Policlinico Umberto I|Si Azienda Ospedaliera Universitaria Senese.|Aichi Japanese Red Cross Nagoya Daini Hospital|Akita University Hospital|Fukui University Of Fukui Hospital|Gunma Gunma University Hospital|Hyogo Kobe University Hospital|Kanagawa Yokohama City University Medical Center|Miyagi Tohoku University Hospital|Osaka Osaka City University Hospital|Shizuoka Shizuoka Cancer Center|Tokyo National Hospital Organization Disaster Medical Center|Hospital General De MÃ©xico Dr. Eduardo Liceaga|MÃ©x Instituto Nacional De CancerologÃ­a|Klinika Hematologii I Transplantologii Uniwersyteckie Centrum Kliniczne|Cluj Institutul Oncologic 'Prof. Dr. Ion Chiricuta'|Dolj Spitalul Clinic Municipal Filantropia Craiova, Sectia Clinica Hematologie|Spitalul Universitar De Urgenta Militar Central \"Dr. Carol Davila\" Bucuresti|Hospital Del Mar|Sektionen For Hematologi Och Koagulation|, Surrey The Royal Marsden Nhs Foundation Trust|, West Midlands University Hospitals Birmingham Nhs Foundation Trust|Barts Health Nhs Trust|Keck Hospital Of Usc|Tufts Medical Center Investigational Pharmacy|Midamerica Division, Inc., C/O Research Medical Center|Northwell Health/Monter Cancer Center|Taussig Cancer Center Investigational Pharmacy|Ohsu Center For Health And Healing|Centennial Medical Center|Baylor Scott And White Research Institute|Swedish Cancer Institute",{"$nulls":3},"Pfizer CT.gov Call Center","2019-10-20","2020-05-25T16:39:39.893","2020-05-26T17:10:42.972","NCT03416179"]
["5ecbf4ccfe30261b1a0483c5","NCT03416179","2019-11-08","Pfizer","PFE","Recruiting","A Study Evaluating Intensive Chemotherapy With or Without Glasdegib or Azacitidine With or Without Glasdegib In Patients With Previously Untreated Acute Myeloid Leukemia (BRIGHT AML1019)","Glasdegib|Cytarabine|Daunorubicin|Azacitidine","Hh Inhibitor|DNA Polymerase Inhibitor|Nucleic Acid Synthesis Inhibitor|TOP2 Inhibitor|DNA Mtase Inhibitor","Unknown",null,"Unknown",null,"Phase 3",4,720,"Anticipated","2018-04-20","2020-02-14","OS","Overall Survival",{"$nulls":3},"Glasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).\n\nGlasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).","Two separate registration trials conducted under one protocol number are proposed to adequately and independently evaluate the addition of glasdegib in intensive and non-intensive chemotherapy populations. Each study will have an experimental treatment arm and a placebo arm. Endpoints are the same for each study except where specifically indicated.\n\nAssignment to the Intensive Study or the Non-Intensive Study will be made by the Investigator based on the 2017 European LeukemiaNet (ELN) recommendations.\n\nStudy B1371019 is a randomized (1:1), double-blind, multi-center, placebo controlled study of chemotherapy in combination with glasdegib versus chemotherapy in combination with placebo in adult patients with previously untreated AML.\n\nGlasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).\n\nGlasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).","A RANDOMIZED (1:1), DOUBLE-BLIND, MULTI-CENTER, PLACEBO CONTROLLED STUDY EVALUATING INTENSIVE CHEMOTHERAPY WITH OR WITHOUT GLASDEGIB (PF-04449913) OR AZACITIDINE (AZA) WITH OR WITHOUT GLASDEGIB IN PATIENTS WITH PREVIOUSLY UNTREATED ACUTE MYELOID LEUKEMIA","B1371019","Leukemia, Myeloid, Acute","Acute Leukemia|Acute Myeloid Leukemia|Myeloid Leukemia|Leukemia","Oncology Hematological","Oncology","Experimental|Placebo Comparator","Arm A (Intensive Study)|Arm B (Intensive Study)|Arm A (Non-intensive study)|Arm B (Non-intensive study)","Glasdegib + '7+3' Induction(s)|Placebo + '7+3' Induction(s)|Glasdegib + azacitidine|Placebo + azacitidine","Drug|Procedure","glasdegib|daunorubicin + cytarabine|cytarabine|HSCT|Placebo|azacitidine","Daily Glasdegib (100 mg, PO), beginning on Day 1 and is to continue up to 2 years post randomization.\n\nFollowing consolidation therapy, glasdegib or placebo will be administered daily for up to 2 years after randomization or until they have minimal residual disease (MRD) negative disease, whichever comes first.\n\nDaily Glasdegib (100 mg, PO) or matching placebo will continue throughout Induction(s) and Consolidation therapies regardless of dose modifications/delays in the chemotherapy.|Consolidation with single agent cytarabine 3 g/m2 IV for adults <60 years and 1 g/m2 for adults 60 years over 3 BID on Days 1, 3, and 5, every 28 days for up to 4 cycles or alternative single agent cytarabine consolidation schedules may be used per local prescribing information.|If required, and done per standard of care post Induction(s).|Azacitidine (75 mg/m2, SC or IV) daily for 7 days, in 28 day cycles for as long as they do not meet the criteria for disease progression, unacceptable toxicity, consent withdrawal, or death.|Matching placebo (PO) is to be administered by mouth daily beginning on Day 1 of chemotherapy and will continue if subjects demonstrate reasonable evidence of clinical benefit and do not meet the criteria for progression regardless of any delays/modifications in the chemotherapy treatment. Subjects will continue placebo until disease progression, unacceptable toxicity, consent withdrawal, or death, whichever comes first.","PF-04449913","Arm A (Intensive Study)|Arm B (Intensive Study)|Arm A (Non-intensive study)|Arm B (Non-intensive study)","\n\nSubjects must meet all of the following inclusion criteria to be eligible for enrollment into the Intensive and Non Intensive study (unless where indicated):\n\n 1.  Subjects with untreated AML according to the World Health Organization (WHO) 2016 Classification2, including those with: * AML arising from MDS or another antecedent hematologic disease (AHD).\n      * AML after previous cytotoxic therapy or radiation (secondary AML).\n     \n     \n 2.  18 years of age (In Japan, 20 years of age).\n 3.  Adequate Organ Function as defined by the following: * Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) 3 x upper limit of normal (ULN), excluding subjects with liver function abnormalities due to underlying malignancy.\n      * Total serum bilirubin 2 x ULN (except subjects with documented Gilbert's syndrome).\n      * Estimated creatinine clearance 30 mL/min as calculated using the standard method for the institution.\n     \n     \n 4.  QTc interval 470 msec using the Fridericia correction (QTcF).\n 5.  All anti cancer treatments (unless specified) should be discontinued 2 weeks from study entry, for example: targeted chemotherapy, radiotherapy, investigational agents, hormones, anagrelide or cytokines. * For control of rapidly progressing leukemia, all trans retinoic acid (ATRA), hydroxyurea, and/or leukopheresis may be used before and for up to 1 week after the first dose of glasdegib.\n     \n     \n 6.  Serum or urine pregnancy test (for female subjects of childbearing potential) with a minimum sensitivity of 25 IU/L or equivalent units of human chorionic gonadotropin (hCG) negative at screening.\n 7.  Male and female subjects of childbearing potential and at risk for pregnancy must agree to use at least one highly effective method of contraception throughout the study and for 180 days after the last dose of azacitidine, cytarabine, or daunorubicin; and the last dose of glasdegib or placebo, whichever occurs later.\n 8.  Female subjects of non childbearing potential must meet at least 1 of the following criteria: 1. Have undergone a documented hysterectomy and/or bilateral oophorectomy;\n      2. Have medically confirmed ovarian failure; or\n      3. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; status may be confirmed by having a serum follicle stimulating hormone (FSH) level confirming the postmenopausal state.\n     \n     All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential.\n     \n     \n 9.  Consent to a saliva sample collection for a germline comparator, unless prohibited by local regulations or ethics committee (EC) decision.\n 10. Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.\n 11. Subjects who are willing and able to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures (including bone marrow [BM] assessments).\n\n","\n\nSubjects with any of the following characteristics/conditions will not be included in the study:\n\n 1.  Acute Promyelocytic Leukemia (APL) and APLwith PML RARA, subjects (WHO 2016 classification).\n 2.  AML with BCR ABL1 or t(9;22)(q34;q11.2) as a sole abnormality. * Complex genetics may include t(9;22) cytogenetic translocation.\n     \n     \n 3.  Subjects with known active CNS leukemia.\n 4.  Participation in other clinical studies involving other investigational drug(s) (Phases 1 4) within 4 weeks prior study entry and/or during study participation.\n 5.  Subjects known to be refractory to platelet or packed red cell transfusions per Institutional Guidelines, or a patient who refuses blood product support.\n 6.  Subjects with another active malignancy on treatment with the exception of basal cell carcinoma, non melanoma skin cancer, cervical carcinoma in situ. Other prior or concurrent malignancies will be considered on a case by case basis.\n 7.  Any one of the following ongoing or in the previous 6 months: myocardial infarction, congenital long QT syndrome, Torsades de pointes, symptomatic arrhythmias (including sustained ventricular tachyarrhythmia), right or left bundle branch block and bifascicular block, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (CHF New York Heart Association class III or IV), cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism; as well as bradycardia defined as <50 bpms.\n 8.  Subjects with an active, life threatening or clinically significant uncontrolled systemic infection not related to AML.\n 9.  Subjects with left ventricular ejection fraction (LVEF) <50% are excluded from the Intensive Chemotherapy Study only.\n 10. Cumulative anthracycline dose equivalent of 550 mg/m2 of daunorubicin for the Intensive Chemotherapy Study only.\n 11. Known malabsorption syndrome or other condition that may significantly impair absorption of study medication in the investigator's judgment (eg, gastrectomy, lap band, Crohn's disease) and inability or unwillingness to swallow tablets or capsules.\n 12. Current use or anticipated requirement for drugs that are known strong CYP3A4/5 inducers.\n 13. Concurrent administration of herbal preparations.\n 14. Major surgery or radiation within 4 weeks of starting study treatment.\n 15. Documented or suspected hypersensitivity to any one of the following: * For subjects assigned to intensive chemotherapy, documented or suspected hypersensitivity to cytarabine (not including drug fever or exanthema, including known cerebellar side effects) or daunorubicin.\n      * For subjects assigned to non intensive chemotherapy, documented or suspected hypersensitivity to azacitidine or mannitol.\n     \n     \n 16. Known active drug or alcohol abuse.\n 17. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.\n 18. Pregnant females or breastfeeding female subjects.\n 19. Known recent or active suicidal ideation or behavior.\n 20. Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.","FSH",null,"Protein","Ovary","Actual","2018-01-31","Actual","Anticipated","2025-07-22","Anticipated","2019-11-01","2017-12-21","2018-01-23","2019-11-07","Yes","glasdegib;\nuntreated;\nHedgehog Inhibitor","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"All",null,"No","Yes\nPfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",null,"URL: https://pmiform.com/clinical-trial-info-request?StudyID=B1371019 [https://pmiform.com/clinical-trial-info-request?StudyID=B1371019] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To obtain contact information for a study center near you, click here.",null,"Yes","No",{"$nulls":17},"2017-002822-19|BRIGHT|BRIGHT AML1019","EudraCT Number|Alias Study Number","Overall survival","5 years after last subject randomized",null,"Fatigue score measured by the MD Anderson Symptom Inventory (MDASI)-AML/MDS questionnaire|Rate of Complete Remission (CR) (including CR with minimal residual disease (MRD)-negative as assessed by multiparametric flow cytometry)|Duration of response (defined as CR [includes CR-MRD negative]/CRi or CR/CRh as appropriate)|Time to response (CR[includes CR-MRD negative)]/CR with partial hematologic rcovery (CRh) as appropriate)|Event-free Survival|Patient Reported Outcomes (PROs) as measured by the M.D. Anderson Symptom Inventory AML/MDS Module (MDASI-AML/MDS)|Adverse events as graded by NCI CTCAE v4.03|Laboratory abnormalities as graded by NCI CTCAE v4.03|For the intensive study, the plasma trough concentration (Ctrough) will be analyzed|QTc interval|PROs as measured by Patient Global Impression of Change (PGIC)|Patient Reported Outcomes (PROs) as measured by EuroQoL 5 Dimension questionnaire 5-Level version (EQ-5D-5L)|Patient Reported Outcomes (PROs) as measured by Patient Global Impression of Symptoms (PGIS)|Complete Remission with incomplete hematologic recovery (CRi)|Rate of morphological leukemia-free state (MLFS)|Rate of Partial Remission (PR)|Rate of Complete Remission with partial hematological recovery (CRh) for the Non-intensive study only only|Minimum Observed Plasma Trough Concentratrion of glasdegib in the Intensive Study|Minimum Observed Plasma Trough Concentration of glasdegib in the Non-intensive study","Scale is from 0-10 where 0 is not present and 10 is as bad as you can image.|Response as defined by the 2017 European LeukemiaNet (ELN) recommendations.|5 years after last subject randomized, consent withdrawal, or death|Measurement Scale from 0-10.|PK samples taken on Induction(s) Day 1 (1 and 4 hours post induction); Induction(s) Day 10 (pre-dose, 1 and 4 hours post dose); Day 1 of each Consolidation cycle (pre-dose, 1 and 4 hours post dose)|One question asking for description of leukemia symptoms.|Series of questions that ask for information that best describes health.|One question asking for information regarding leukemia symptoms.|Its the minimum trough concentration in plasma of glasdegib following multiple daily dosing to steady state.|It is the minimum trough concentration in plasma of glasdegib following multiple daily dosing to steady state.","5 years after last subject randomized, consent withdrawal, or death|2 years after last dose of study therapy|5 years after last patient randomized, withdrawal, or death|5 years after last subject randomized, withdrawal, or death|Day 10 of Induction Cycle and Day 1 of each Consolidation Cycle|Cycle 1 Day 15 and Cycles 2 and 3 on Day 1","ClinicalTrials.gov_Inquiries@pfizer.com","Pfizer CT.gov Call Center","1-800-718-1021","Adelaide, South|Darlinghurst, New South Wales, Australia, 2010 St George HospitalKogarah, New South Wales, Australia, 2217|Wels, Upper|Salzburg, Austria, 5020 Uniklinikum Salzburg, Landeskrankenhaus SalzburgSalzburg, Austria, 5020 Klinikum Wels-Grieskirchen GmbhWels, Austria, 4600 Sozialmedizinisches Zentrum Sud.Wien, Austria, 1100 Krankenhaus Hietzing Mit Neurologischem Zentrum RosenhugelWien, Austria, 1130|Brugge, Belgium, B-8000 Az Sint-Jan Brugge-Oostende AvBrugge, Belgium, B-8000 Universitaire Ziekenhuizen Brussel (Uz Brussel)Brussels, Belgium, B-1090 Universitaire Ziekenhuizen BrusselBrussels, Belgium, B-1090 Universitaire Ziekenhuizen LeuvenLeuven, Belgium, B-3000|Winnipeg, Manitoba, Canada, R3A 1R9 Cancercare ManitobaWinnipeg, Manitoba, Canada, R3E 0V9|Toronto, Ontario, Canada, M4N 3M5 Princess Margaret Cancer CentreToronto, Ontario, Canada, M5G 2M9|Montreal, Quebec, Canada, H1T 2M4|Hefei, Anhui, China, 230001 Anhui Provincial HospitalHefei, Anhui, China, 230071|Fuzhou, Fujian, China, 350001|Guangzhou, Guangdong, China, 510080 Guangdong Second Provincial General HospitalGuangzhou, Guangdong, China, 510317|Langfang, Hebei, China, 065201|Zhengzhou, Henan, China, 450003 Henan Cancer HostipalZhengzhou, Henan, China, 450008|Chengdu, Sichuan, China, 610041|Wuhan, Hubei, China, 430030|Nanjing, Jiangsu, China, 210029|Shanghai, China, 200025|Qingdao, Shandong, China, 266071|Shanghai, Shanghai, China, 200080|Xi'An, Shannxi, China, 710061|Tianjin, Tianjin, China, 300020|Hangzhou, Zhejiang, China, 310003|Brno, Czechia, 100 34 Nemocnicni LekarnaBrno, Czechia, 625 00 Ustavni LekarnaOstrava - Poruba, Czechia, 708 52 Klinika HematoonkologieOstrava-Poruba, Czechia, 708 52 InternÃ­ HematologickÃ¡ Klinika, Fakultni Nemocnice KrÃ¡lovskÃ© VinohradyPraha 10, Czechia, 100 34 Ãšstavni LÃ©kÃ¡rnaPraha 10, Czechia, 100 34|Creteil, France, 94010 Chu Henri MondorCrÃ©teil, France, 94010 Chu De NantesNantes Cedex 1, France, 44093 Chu De Nantes Hotel DieuNantes Cedex, France, 44093 Hopital Saint LouisParis, France, 75010 Centre Hospitalier Lyon Sud - Service D'HematologiePierre Benite Cedex, France, 69495 Centre Hospitalier Lyon Sud -Unite De Pharmacie Clinique OncologiquePierre Benite Cedex, France, 69495 Institut Gustave RoussyVillejuif Cedex, France, 94805|Koeln, North Rhine Westphalia, Germany, 50937|Muenster, North-Rhine-Westphalia, Germany, 48149|Hamburg, Germany, 20246 Medizinische Hochschule HannoverHannover, Germany, 30625 UniversitÃ¤tsklinikum KÃ¶lnKoeln, Germany, 50937 Philipps-Universitaet MarburgMarburg, Germany, 35032|Thessaloniki, Greece, 57010|Debrecen, Hungary, 4032 Debreceni Egyetem Klinikai Kozpont Belgyogyaszati KlinikaDebrecen, Hungary, 4032 Petz AladÃ¡r Megyei OktatÃ³ KÃ³rhÃ¡z, GyÃ³gyszerÃ©szeti OsztÃ¡lyGyÅ‘r, Hungary, 9024 Petz AladÃ¡r Megyei OktatÃ³ KÃ³rhÃ¡z, Ii. BelgyÃ³gyÃ¡szat- HematolÃ³giai OsztÃ¡lyGyÅ‘r, Hungary, 9024 Somogy Megyei Kaposi Mor Oktato KorhazKaposvar, Hungary, 7400 Szabolcs-Szatmar Bereg Megyei Korhazak Es Egyetemi Oktatokorhaz, Josa Andras Korhaz, HematologiaNyiregyhaza, Hungary, 4400 Szabolcs-Szatmar Bereg Megyei Korhazak Es Egyetemi Oktatokorhaz, Josa Andras Korhaz,Nyiregyhaza, Hungary, 4400|Boston, Massachusetts, United States, 02215|Haifa, Israel, 3109601 Shaare Zedek Medical CenterJerusalem, Israel, 9103102 Hadassah Medical Center (Ein Kerem)Jerusalem, Israel, 91120 Hemato-Oncology Ambulatory ServicePetah Tikva, Israel, 4941492 Hematology Division - Oncology PharmacyPetah Tikva, Israel, 4941492 Rabin Medical Center, Beilinson HospitalPetah Tikva, Israel, 4941492 Tel-Aviv Sourasky Medical CenterTel Aviv, Israel, 6423906|Torette Di Ancona, An, Italy, 60126|Torrette Di Ancona, Ancona, Italy, 60126|Bologna, Italy, 40138 Azienda Ospedaliera Universitaria SeneseSiena, Italy, 53100|Meldola, Fc, Italy, 47014|Cona, Ferrara, Fe, Italy, 44124 Farmacia OspedalieraFerrara, Fe, Italy, 44121|Pesaro, Pu, Italy, 61122|Roma, Rm, Italy, 00161|Siena, Si, Italy, 53100|Nagoya, Aichi, Japan, 466-8650|Akita, Japan, 010-8543 Kyushu University HospitalFukuoka, Japan, 812-8582 National Hospital Organization Kumamoto Medical Center[Active, Not Recruiting]Kumamoto, Japan, 860-0008 Nagasaki University HospitalNagasaki, Japan, 852-8501 Tokyo Medical University HospitalTokyo, Japan, 160-0023 Korea, Republic Of, Jeollabuk-Do Chonbuk National University Hospital[Active, Not Recruiting]Jeonju-Si, Jeollabuk-Do, Korea, Republic Of, 54907 Korea, Republic Of, Jeollanam-Do Chonnam National University Hwasun HospitalHwasun-Gun, Jeollanam-Do, Korea, Republic Of, 58128 Korea, Republic Of Department Of Pharmacy, Inje University Busan Paik HospitalBusan, Korea, Republic Of, 47392 Inje University Busan Paik HospitalBusan, Korea, Republic Of, 47392 Clinical Trial Pharmacy, Keimyung University Dongsan HospitalDaegu, Korea, Republic Of, 42601 Keimyung University Dongsan HospitalDaegu, Korea, Republic Of, 42601 Gachon University Gil Medical CenterIncheon, Korea, Republic Of, 21565 Seoul National University HospitalSeoul, Korea, Republic Of, 03080 Clinical Trial Center, Severance Hospital, Yonsei University Health SystemSeoul, Korea, Republic Of, 03722 Severance Hospital, Yonsei University Health SystemSeoul, Korea, Republic Of, 03722 Department Of Pharmacy, Samsung Medical CenterSeoul, Korea, Republic Of, 06351 Samsung Medical CenterSeoul, Korea, Republic Of, 06351 Department Of Pharmacy, Severance Hospital, Yonsei University Health SystemSeoul, Korea, Republic Of, 06591 The Catholic University Of Korea Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591 The Catholic University Of Korea, Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591|Yoshida-Gun, Fukui, Japan, 910-1193|Maebashi, Gunma, Japan, 371-8511|Kobe-Shi, Hyogo, Japan, 650-0017|Yokohama, Kanagawa, Japan, 232-0024|Sendai, Miyagi, Japan, 980-8574|Osaka-City, Osaka, Japan, 545-8586 Kindai University HospitalOsaka-Sayama, Osaka, Japan, 589-8511|Sunto-Gun, Shizuoka, Japan, 411-8777|Tachikawa, Tokyo, Japan, 190-0014|MÃ©xico, Mexico, 06726|MÃ©xico, MÃ©x, Mexico, 14080|Gdansk, Poland, 80-214 Wwcoit Im. M. Kopernika W LodziLodz, Poland, 93-513|Cluj-Napoca, Cluj, Romania, 400124|Craiova, Dolj, Romania, 200136|Bucuresti, Romania, 010825 Spitalul Clinic Coltea, Clinica De HematologieBucuresti, Romania, 030171 Russian Federation Sbhi Cch No. 40 Hd MoscowMoscow, Russian Federation, 129301 State Budgetary Healthcare Institution Of MoscowMoscow, Russian Federation, 129301 Sbhi Nnr Nn Rch N. A. N.A. SemashkoNizhniy Novgorod, Russian Federation, 603126 State Budgetary Institution Of Ryazan Region 'Regional Clinical Hospital' (Sbi Rr Rch)Ryazan, Russian Federation, 390039 Fsbi Russrhti Fmba Of|Barcelona, Spain, 08003 Hospital De La Santa Creu I Sant PauBarcelona, Spain, 08025 Hospital Universitario Arnau De VilanovaLleida, Spain, 25198 Hospital General Universitario Gregorio MaranonMadrid, Spain, 28007 Hospital Universitario Ramon Y CajalMadrid, Spain, 28034 Hospital Universitario Virgen Del RocioSevilla, Spain, 41013 Hospital Universitari I Politecnic La FeValencia, Spain, 46026|Goteborg, Sweden, 413 45 Apl, Apl Sahlgrenska, Kliniska ProvningarGoteborg, Sweden, 413 46 Apoex VnOrebro, Sweden, 701 85 Universitetssjukhuset OrebroOrebro, Sweden, 701 85 Apoex Ab Nks, Kliniska ProvningarSolna, Sweden, 171 64 Karolinska Universitetssjukhuset HuddingeStockholm, Sweden, 141 86 Taiwan National Cheng Kung University HospitalTainan, Taiwan, 704 National Taiwan University HospitalTaipei, Taiwan, 100 Department Of Clinical Trial Pharmacy, Taipei Veterans General HospitalTaipei, Taiwan, 11217 Taipei Veterans General HospitalTaipei, Taiwan, 11217 Division Of Pharmacy, Koo Foundation Sun Yat-Sen Cancer CenterTaipei, Taiwan, 112 Koo Foundation Sun Yat-Sen Cancer CenterTaipei, Taiwan, 112 Chang Gung Memorial Hospital-Linkou BranchTaoyuan City, Taiwan, 333 Chemotherapy Pharmacy, Chang Gung Memorial Hospital-Linkou BranchTaoyuan City, Taiwan, 333|Sutton, Surrey, United Kingdom, Sm2 5Pt|Birmingham, West Midlands, United Kingdom, B15 2Th University Hospitals Birmingham Nhs Foundation TrustBirmingham, West Midlands, United Kingdom, B30 3Hg|London, United Kingdom, Ec1A 7Be Imperial College Healthcare Nhs TrustLondon, United Kingdom, W12 0Hs|Los Angeles, California, United States, 90033 Lac+Usc Medical CenterLos Angeles, California, United States, 90033 Usc/Norris Comprehensive Cancer Center / Investigational Drug ServicesLos Angeles, California, United States, 90033 Usc/Norris Comprehensive Cancer CenterLos Angeles, California, United States, 90033 Rrmc - UclaLos Angeles, California, United States, 90095 Ucla Department Of MedicineLos Angeles, California, United States, 90095 Ucla Drug Information/Investigational DrugsLos Angeles, California, United States, 90095 Ucla Hematology/Oncology ClinicLos Angeles, California, United States, 90095 Ucla Ronald Reagan Medical CenterLos Angeles, California, United States, 90095 Keck Medicine Of Usc Norris Oncology/Hematology - Newport Beach Treatment CenterNewport Beach, California, United States, 92663 Usc Norris Oncology/Hematology - Newport BeachNewport Beach, California, United States, 92663 Uc Irvine Health - Chao Family Comprehensive Cancer CenterOrange, California, United States, 92868-3201 Uc Irvine Medical CenterOrange, California, United States, 92868-3201 Ucsf Helen Diller Family Comprehensive Cancer CenterSan Francisco, California, United States, 94143 University Of California, San Francisco Medical CenterSan Francisco, California, United States, 94143 University Of California, San FranciscoSan Francisco, California, United States, 94143 Ucla Hematology/Oncology - Westlake VillageWestlake Village, California, United States, 91361|Boston, Massachusetts, United States, 02111 Tufts Medical CenterBoston, Massachusetts, United States, 02111 Massachusetts General HospitalBoston, Massachusetts, United States, 02114 Beth|Kansas City, Missouri, United States, 64132|Buffalo, New York, United States, 14263 Northwell Health/Monter Cancer CenterLake Success, New York, United States, 11042 North Shore University HospitalManhasset, New York, United States, 11030 Long Island Jewish Medical CenterNew Hyde Park, New York, United States, 11040 University Of Rochester Cancer Center PharmacyRochester, New York, United States, 14642 University Of Rochester Medical CenterRochester, New York, United States, 14642|Cleveland, Ohio, United States, 44106 University Hospitals Cleveland Medical CenterCleveland, Ohio, United States, 44106 Cleveland Clinic FoundationCleveland, Ohio, United States, 44195|Portland, Oregon, United States, 97239 Oregon Health & Science University-Research Pharmacy ServicesPortland, Oregon, United States, 97239 Oregon Health & Science UniversityPortland, Oregon, United States, 97239|Nashville, Tennessee, United States, 37203 The Sarah Cannon Research InstituteNashville, Tennessee, United States, 37203 Tristar Bone Marrow TransplantNashville, Tennessee, United States, 37203|Dallas, Texas, United States, 75246 Baylor University Medical CenterDallas, Texas, United States, 75246 Blood Cancer And Stem Cell Transplant ClinicSan Antonio, Texas, United States, 78229 Methodist Healthcare System Of San AntonioSan Antonio, Texas, United States, 78229 Methodist Hospital Investigational PharmacySan Antonio, Texas, United States, 78229|Seattle, Washington, United States, 98104 Swedish First Hill Ids PharmacySeattle, Washington, United States, 98104 Swedish Medical CenterSeattle, Washington, United States, 98122","California|Massachusetts|Missouri|New York|Ohio|Oregon|Tennessee|Texas|Washington","Australia|Austria|Belgium|Canada|China|Czechia|France|Germany|Greece|Hungary|Israel|Italy|Japan|Mexico|Poland|Romania|Spain|Sweden|United Kingdom|United States","Australia, 5000 Royal Adelaide Hospital|New South Wales St Vincent's Hospital Sydney|Royal Adelaide Hospital - Clinical Trials Pharmacy|Klinikum Wels-Grieskirchen Gmbh|Landeskrankenhaus Salzburg, Universitatsklinik Fur Innere Medizin Iii Der Pmu|Az Sint-Jan Brugge - Oostende Av|Manitoba Health Sciences Centre|Ontario Sunnybrook Research Institute|Quebec Ciusss De L'Est-De-L'Ile-De- MontrÃ©al - HÃ´pital Maisonneuve-Rosemont|Anhui The First Affiliated Hospital Of Ustc, Anhui Province Hospital|Fujian Fujian Medical University Union Hospital|Guangdong Guangdong Provincial People's Hospital|Hebei Hebei Yanda Lu Daopei Hospital|Henan Henan Provincial People's Hospital/Hematology Department|Hospital, Sichuan University|Hubei Tongji Hospital, Tongji Medical College, Huazhong University Of Science & Technology/Cancer Center|Jiangsu Jiangsu Province Hospital|Ruijin Hospital Affiliated To Shanghai Jiaotong University School Of Medicine|Shandong Affiliated Hospital Of Qingdao University/Hematology Department|Shanghai Shanghai General Hospital|Shannxi The First Affiliated Hospital Of Xi'An Jiaotong University|Tianjin Institute Of Hematology And Blood Diseases Hospital, Chinese Academy Of Medical Sciences|Zhejiang The First Affiliated Hospital College Of Medicine, Zhejiang University|Interni Hematologicka A Onkologicka Klinika, Fakultni Nemocnice Brno|Chu Henri Mondor|North Rhine Westphalia UniversitÃ¤tsklinikum KÃ¶ln|North-Rhine-Westphalia Universitaetsklinikum Muenster|Universitaetsklinikum Hamburg-Eppendorf|General Hospital Of Thessaloniki|Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Klinika, Hematologia Tanszek|Deaconess Medical Center|Rambam Health Care Campus|An Sod Farmacia-Dipt Dei Servizi -Aou Ospedali Riuniti Umberto I, G.M. Lancisi, G. Salesi|Ancona Aou Ospedali Riuniti Umberto I, G.M. Lancisi, G. Salesi, Clinica Di Ematologia|Azienda Ospedaliero Universitaria Di Bologna Policlinico S.Orsola Malpighi|Fc Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori|Fe A.O.U. Di Ferrara- Arcispedale Sant'Anna,|Pu Ao Ospedali Riuniti Marche Nord - Presidio Ospedaliero San Salvatore Di Pesaro -|Rm Azienda Ospedaliero Universitaria Policlinico Umberto I|Si Azienda Ospedaliera Universitaria Senese.|Aichi Japanese Red Cross Nagoya Daini Hospital|Akita University Hospital|Fukui University Of Fukui Hospital|Gunma Gunma University Hospital|Hyogo Kobe University Hospital|Kanagawa Yokohama City University Medical Center|Miyagi Tohoku University Hospital|Osaka Osaka City University Hospital|Shizuoka Shizuoka Cancer Center|Tokyo National Hospital Organization Disaster Medical Center|Hospital General De MÃ©xico Dr. Eduardo Liceaga|MÃ©x Instituto Nacional De CancerologÃ­a|Klinika Hematologii I Transplantologii Uniwersyteckie Centrum Kliniczne|Cluj Institutul Oncologic 'Prof. Dr. Ion Chiricuta'|Dolj Spitalul Clinic Municipal Filantropia Craiova, Sectia Clinica Hematologie|Spitalul Universitar De Urgenta Militar Central \"Dr. Carol Davila\" Bucuresti|Hospital Del Mar|Sektionen For Hematologi Och Koagulation|, Surrey The Royal Marsden Nhs Foundation Trust|, West Midlands University Hospitals Birmingham Nhs Foundation Trust|Barts Health Nhs Trust|Keck Hospital Of Usc|Tufts Medical Center Investigational Pharmacy|Midamerica Division, Inc., C/O Research Medical Center|Roswell Park Cancer Institute|Taussig Cancer Center Investigational Pharmacy|Ohsu Center For Health And Healing|Centennial Medical Center|Baylor Scott And White Research Institute|Swedish Cancer Institute",{"$nulls":3},"Pfizer CT.gov Call Center","2019-11-07","2020-05-25T16:39:40.396","2020-05-26T17:10:42.972","NCT03416179"]
["5ecbf4ccfeab101b155309f4","NCT03416179","2019-12-16","Pfizer","PFE","Recruiting","A Study Evaluating Intensive Chemotherapy With or Without Glasdegib or Azacitidine With or Without Glasdegib In Patients With Previously Untreated Acute Myeloid Leukemia (BRIGHT AML1019)","Glasdegib|Cytarabine|Daunorubicin|Azacitidine","Hh Inhibitor|DNA Polymerase Inhibitor|Nucleic Acid Synthesis Inhibitor|TOP2 Inhibitor|DNA Mtase Inhibitor","Unknown",null,"Unknown",null,"Phase 3",4,720,"Anticipated","2018-04-20","2020-03-21","OS","Overall Survival",{"$nulls":3},"Glasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).\n\nGlasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).","Two separate registration trials conducted under one protocol number are proposed to adequately and independently evaluate the addition of glasdegib in intensive and non-intensive chemotherapy populations. Each study will have an experimental treatment arm and a placebo arm. Endpoints are the same for each study except where specifically indicated.\n\nAssignment to the Intensive Study or the Non-Intensive Study will be made by the Investigator based on the 2017 European LeukemiaNet (ELN) recommendations.\n\nStudy B1371019 is a randomized (1:1), double-blind, multi-center, placebo controlled study of chemotherapy in combination with glasdegib versus chemotherapy in combination with placebo in adult patients with previously untreated AML.\n\nGlasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).\n\nGlasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).","A RANDOMIZED (1:1), DOUBLE-BLIND, MULTI-CENTER, PLACEBO CONTROLLED STUDY EVALUATING INTENSIVE CHEMOTHERAPY WITH OR WITHOUT GLASDEGIB (PF-04449913) OR AZACITIDINE (AZA) WITH OR WITHOUT GLASDEGIB IN PATIENTS WITH PREVIOUSLY UNTREATED ACUTE MYELOID LEUKEMIA","B1371019","Leukemia, Myeloid, Acute","Acute Leukemia|Acute Myeloid Leukemia|Myeloid Leukemia|Leukemia","Oncology Hematological","Oncology","Experimental|Placebo Comparator","Arm A (Intensive Study)|Arm B (Intensive Study)|Arm A (Non-intensive study)|Arm B (Non-intensive study)","Glasdegib + '7+3' Induction(s)|Placebo + '7+3' Induction(s)|Glasdegib + azacitidine|Placebo + azacitidine","Drug|Procedure","glasdegib|daunorubicin + cytarabine|cytarabine|HSCT|Placebo|azacitidine","Daily Glasdegib (100 mg, PO), beginning on Day 1 and is to continue up to 2 years post randomization.\n\nFollowing consolidation therapy, glasdegib or placebo will be administered daily for up to 2 years after randomization or until they have minimal residual disease (MRD) negative disease, whichever comes first.\n\nDaily Glasdegib (100 mg, PO) or matching placebo will continue throughout Induction(s) and Consolidation therapies regardless of dose modifications/delays in the chemotherapy.|Consolidation with single agent cytarabine 3 g/m2 IV for adults <60 years and 1 g/m2 for adults 60 years over 3 BID on Days 1, 3, and 5, every 28 days for up to 4 cycles or alternative single agent cytarabine consolidation schedules may be used per local prescribing information.|If required, and done per standard of care post Induction(s).|Azacitidine (75 mg/m2, SC or IV) daily for 7 days, in 28 day cycles for as long as they do not meet the criteria for disease progression, unacceptable toxicity, consent withdrawal, or death.|Matching placebo (PO) is to be administered by mouth daily beginning on Day 1 of chemotherapy and will continue if subjects demonstrate reasonable evidence of clinical benefit and do not meet the criteria for progression regardless of any delays/modifications in the chemotherapy treatment. Subjects will continue placebo until disease progression, unacceptable toxicity, consent withdrawal, or death, whichever comes first.","PF-04449913","Arm A (Intensive Study)|Arm B (Intensive Study)|Arm A (Non-intensive study)|Arm B (Non-intensive study)","\n\nSubjects must meet all of the following inclusion criteria to be eligible for enrollment into the Intensive and Non Intensive study (unless where indicated):\n\n 1.  Subjects with untreated AML according to the World Health Organization (WHO) 2016 Classification2, including those with: * AML arising from MDS or another antecedent hematologic disease (AHD).\n      * AML after previous cytotoxic therapy or radiation (secondary AML).\n     \n     \n 2.  18 years of age (In Japan, 20 years of age).\n 3.  Adequate Organ Function as defined by the following: * Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) 3 x upper limit of normal (ULN), excluding subjects with liver function abnormalities due to underlying malignancy.\n      * Total serum bilirubin 2 x ULN (except subjects with documented Gilbert's syndrome).\n      * Estimated creatinine clearance 30 mL/min as calculated using the standard method for the institution.\n     \n     \n 4.  QTc interval 470 msec using the Fridericia correction (QTcF).\n 5.  All anti cancer treatments (unless specified) should be discontinued 2 weeks from study entry, for example: targeted chemotherapy, radiotherapy, investigational agents, hormones, anagrelide or cytokines. * For control of rapidly progressing leukemia, all trans retinoic acid (ATRA), hydroxyurea, and/or leukopheresis may be used before and for up to 1 week after the first dose of glasdegib.\n     \n     \n 6.  Serum or urine pregnancy test (for female subjects of childbearing potential) with a minimum sensitivity of 25 IU/L or equivalent units of human chorionic gonadotropin (hCG) negative at screening.\n 7.  Male and female subjects of childbearing potential and at risk for pregnancy must agree to use at least one highly effective method of contraception throughout the study and for 180 days after the last dose of azacitidine, cytarabine, or daunorubicin; and the last dose of glasdegib or placebo, whichever occurs later.\n 8.  Female subjects of non childbearing potential must meet at least 1 of the following criteria: 1. Have undergone a documented hysterectomy and/or bilateral oophorectomy;\n      2. Have medically confirmed ovarian failure; or\n      3. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; status may be confirmed by having a serum follicle stimulating hormone (FSH) level confirming the postmenopausal state.\n     \n     All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential.\n     \n     \n 9.  Consent to a saliva sample collection for a germline comparator, unless prohibited by local regulations or ethics committee (EC) decision.\n 10. Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.\n 11. Subjects who are willing and able to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures (including bone marrow [BM] assessments).\n\n","\n\nSubjects with any of the following characteristics/conditions will not be included in the study:\n\n 1.  Acute Promyelocytic Leukemia (APL) and APLwith PML RARA, subjects (WHO 2016 classification).\n 2.  AML with BCR ABL1 or t(9;22)(q34;q11.2) as a sole abnormality. * Complex genetics may include t(9;22) cytogenetic translocation.\n     \n     \n 3.  Subjects with known active CNS leukemia.\n 4.  Participation in other clinical studies involving other investigational drug(s) (Phases 1 4) within 4 weeks prior study entry and/or during study participation.\n 5.  Subjects known to be refractory to platelet or packed red cell transfusions per Institutional Guidelines, or a patient who refuses blood product support.\n 6.  Subjects with another active malignancy on treatment with the exception of basal cell carcinoma, non melanoma skin cancer, cervical carcinoma in situ. Other prior or concurrent malignancies will be considered on a case by case basis.\n 7.  Any one of the following ongoing or in the previous 6 months: myocardial infarction, congenital long QT syndrome, Torsades de pointes, symptomatic arrhythmias (including sustained ventricular tachyarrhythmia), right or left bundle branch block and bifascicular block, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (CHF New York Heart Association class III or IV), cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism; as well as bradycardia defined as <50 bpms.\n 8.  Subjects with an active, life threatening or clinically significant uncontrolled systemic infection not related to AML.\n 9.  Subjects with left ventricular ejection fraction (LVEF) <50% are excluded from the Intensive Chemotherapy Study only.\n 10. Cumulative anthracycline dose equivalent of 550 mg/m2 of daunorubicin for the Intensive Chemotherapy Study only.\n 11. Known malabsorption syndrome or other condition that may significantly impair absorption of study medication in the investigator's judgment (eg, gastrectomy, lap band, Crohn's disease) and inability or unwillingness to swallow tablets or capsules.\n 12. Current use or anticipated requirement for drugs that are known strong CYP3A4/5 inducers.\n 13. Concurrent administration of herbal preparations.\n 14. Major surgery or radiation within 4 weeks of starting study treatment.\n 15. Documented or suspected hypersensitivity to any one of the following: * For subjects assigned to intensive chemotherapy, documented or suspected hypersensitivity to cytarabine (not including drug fever or exanthema, including known cerebellar side effects) or daunorubicin.\n      * For subjects assigned to non intensive chemotherapy, documented or suspected hypersensitivity to azacitidine or mannitol.\n     \n     \n 16. Known active drug or alcohol abuse.\n 17. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.\n 18. Pregnant females or breastfeeding female subjects.\n 19. Known recent or active suicidal ideation or behavior.\n 20. Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.","FSH",null,"Protein","Ovary","Actual","2018-01-31","Actual","Anticipated","2025-03-28","Anticipated","2019-12-01","2017-12-21","2018-01-23","2019-12-13","Yes","glasdegib;\nuntreated;\nHedgehog Inhibitor","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"All",null,"No","Yes\nPfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",null,"URL: https://pmiform.com/clinical-trial-info-request?StudyID=B1371019 [https://pmiform.com/clinical-trial-info-request?StudyID=B1371019] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To obtain contact information for a study center near you, click here.",null,"Yes","No",{"$nulls":17},"2017-002822-19|BRIGHT|BRIGHT AML1019","EudraCT Number|Alias Study Number","Overall survival","5 years after last subject randomized",null,"Fatigue score measured by the MD Anderson Symptom Inventory (MDASI)-AML/MDS questionnaire|Rate of Complete Remission (CR) (including CR with minimal residual disease (MRD)-negative as assessed by multiparametric flow cytometry)|Duration of response (defined as CR [includes CR-MRD negative]/CRi or CR/CRh as appropriate)|Time to response (CR[includes CR-MRD negative)]/CR with partial hematologic rcovery (CRh) as appropriate)|Event-free Survival|Patient Reported Outcomes (PROs) as measured by the M.D. Anderson Symptom Inventory AML/MDS Module (MDASI-AML/MDS)|Adverse events as graded by NCI CTCAE v4.03|Laboratory abnormalities as graded by NCI CTCAE v4.03|For the intensive study, the plasma trough concentration (Ctrough) will be analyzed|QTc interval|PROs as measured by Patient Global Impression of Change (PGIC)|Patient Reported Outcomes (PROs) as measured by EuroQoL 5 Dimension questionnaire 5-Level version (EQ-5D-5L)|Patient Reported Outcomes (PROs) as measured by Patient Global Impression of Symptoms (PGIS)|Complete Remission with incomplete hematologic recovery (CRi)|Rate of morphological leukemia-free state (MLFS)|Rate of Partial Remission (PR)|Rate of Complete Remission with partial hematological recovery (CRh) for the Non-intensive study only only|Minimum Observed Plasma Trough Concentratrion of glasdegib in the Intensive Study|Minimum Observed Plasma Trough Concentration of glasdegib in the Non-intensive study","Scale is from 0-10 where 0 is not present and 10 is as bad as you can image.|Response as defined by the 2017 European LeukemiaNet (ELN) recommendations.|5 years after last subject randomized, consent withdrawal, or death|Measurement Scale from 0-10.|PK samples taken on Induction(s) Day 1 (1 and 4 hours post induction); Induction(s) Day 10 (pre-dose, 1 and 4 hours post dose); Day 1 of each Consolidation cycle (pre-dose, 1 and 4 hours post dose)|One question asking for description of leukemia symptoms.|Series of questions that ask for information that best describes health.|One question asking for information regarding leukemia symptoms.|Its the minimum trough concentration in plasma of glasdegib following multiple daily dosing to steady state.|It is the minimum trough concentration in plasma of glasdegib following multiple daily dosing to steady state.","5 years after last subject randomized, consent withdrawal, or death|2 years after last dose of study therapy|5 years after last patient randomized, withdrawal, or death|5 years after last subject randomized, withdrawal, or death|Day 10 of Induction Cycle and Day 1 of each Consolidation Cycle|Cycle 1 Day 15 and Cycles 2 and 3 on Day 1","ClinicalTrials.gov_Inquiries@pfizer.com","Pfizer CT.gov Call Center","1-800-718-1021","Adelaide, South|Darlinghurst, New South Wales, Australia, 2010 St George HospitalKogarah, New South Wales, Australia, 2217|Wels, Upper|Salzburg, Austria, 5020 Uniklinikum Salzburg, Landeskrankenhaus SalzburgSalzburg, Austria, 5020 Klinikum Wels-Grieskirchen GmbhWels, Austria, 4600 Sozialmedizinisches Zentrum Sud.Wien, Austria, 1100 Krankenhaus Hietzing Mit Neurologischem Zentrum RosenhugelWien, Austria, 1130|Brugge, Belgium, B-8000 Az Sint-Jan Brugge-Oostende AvBrugge, Belgium, B-8000 Universitaire Ziekenhuizen Brussel (Uz Brussel)Brussels, Belgium, B-1090 Universitaire Ziekenhuizen BrusselBrussels, Belgium, B-1090 Universitaire Ziekenhuizen LeuvenLeuven, Belgium, B-3000|Winnipeg, Manitoba, Canada, R3A 1R9 Cancercare ManitobaWinnipeg, Manitoba, Canada, R3E 0V9|Toronto, Ontario, Canada, M4N 3M5 Princess Margaret Cancer CentreToronto, Ontario, Canada, M5G 2M9|Montreal, Quebec, Canada, H1T 2M4|Saskatoon, Saskatchewan, Canada, S7N 0W8 Saskatoon Cancer CentreSaskatoon, Saskatchewan, Canada, S7N 4H4|Hefei, Anhui, China, 230001 Anhui Provincial HospitalHefei, Anhui, China, 230071|Fuzhou, Fujian, China, 350001|Guangzhou, Guangdong, China, 510080 Guangdong Second Provincial General HospitalGuangzhou, Guangdong, China, 510317|Langfang, Hebei, China, 065201|Zhengzhou, Henan, China, 450003 Henan Cancer HostipalZhengzhou, Henan, China, 450008|Chengdu, Sichuan, China, 610041|Wuhan, Hubei, China, 430030|Nanjing, Jiangsu, China, 210029|Beijing, China, 100044 Ruijin Hospital Affiliated To Shanghai Jiaotong University School Of MedicineShanghai, China, 200025|Shanghai, Shanghai, China, 200080|Xi'An, Shannxi, China, 710061|Tianjin, Tianjin, China, 300020|Hangzhou, Zhejiang, China, 310003|Brno, Czechia, 100 34 Nemocnicni LekarnaBrno, Czechia, 625 00 Ustavni LekarnaOstrava - Poruba, Czechia, 708 52 Klinika HematoonkologieOstrava-Poruba, Czechia, 708 52 InternÃ­ HematologickÃ¡ Klinika, Fakultni Nemocnice KrÃ¡lovskÃ© VinohradyPraha 10, Czechia, 100 34 Ãšstavni LÃ©kÃ¡rnaPraha 10, Czechia, 100 34|Creteil, France, 94010 Chu Henri MondorCrÃ©teil, France, 94010 Chu De NantesNantes Cedex 1, France, 44093 Chu De Nantes Hotel DieuNantes Cedex, France, 44093 Hopital Saint LouisParis, France, 75010 Centre Hospitalier Lyon Sud - Service D'HematologiePierre Benite Cedex, France, 69495 Centre Hospitalier Lyon Sud -Unite De Pharmacie Clinique OncologiquePierre Benite Cedex, France, 69495 Institut Gustave RoussyVillejuif Cedex, France, 94805|Augusta, Georgia, United States, 30912|Munich, Bavaria, Germany, 81377|Marburg, Hesse, Germany, 35032|Koeln, North Rhine Westphalia, Germany, 50937|Muenster, North-Rhine-Westphalia, Germany, 48149|Hamburg, Germany, 20246 Medizinische Hochschule HannoverHannover, Germany, 30625|Thessaloniki, Greece, 57010|Debrecen, Hungary, 4032 Debreceni Egyetem Klinikai Kozpont Belgyogyaszati KlinikaDebrecen, Hungary, 4032 Petz AladÃ¡r Megyei OktatÃ³ KÃ³rhÃ¡z, GyÃ³gyszerÃ©szeti OsztÃ¡lyGyÅ‘r, Hungary, 9024 Petz AladÃ¡r Megyei OktatÃ³ KÃ³rhÃ¡z, Ii. BelgyÃ³gyÃ¡szat- HematolÃ³giai OsztÃ¡lyGyÅ‘r, Hungary, 9024 Somogy Megyei Kaposi Mor Oktato KorhazKaposvar, Hungary, 7400 Szabolcs-Szatmar Bereg Megyei Korhazak Es Egyetemi Oktatokorhaz, Josa Andras Korhaz, HematologiaNyiregyhaza, Hungary, 4400 Szabolcs-Szatmar Bereg Megyei Korhazak Es Egyetemi Oktatokorhaz, Josa Andras Korhaz,Nyiregyhaza, Hungary, 4400|Boston, Massachusetts, United States, 02215|Haifa, Israel, 3109601 Shaare Zedek Medical CenterJerusalem, Israel, 9103102 Hadassah Medical Center (Ein Kerem)Jerusalem, Israel, 91120 Hemato-Oncology Ambulatory ServicePetah Tikva, Israel, 4941492 Hematology Division - Oncology PharmacyPetah Tikva, Israel, 4941492 Rabin Medical Center, Beilinson HospitalPetah Tikva, Israel, 4941492 Tel-Aviv Sourasky Medical CenterTel Aviv, Israel, 6423906|Torette Di Ancona, An, Italy, 60126|Torrette Di Ancona, Ancona, Italy, 60126|Bologna, Italy, 40138 Azienda Ospedaliera Universitaria SeneseSiena, Italy, 53100|Meldola, Fc, Italy, 47014|Cona, Ferrara, Fe, Italy, 44124 Farmacia OspedalieraFerrara, Fe, Italy, 44121|Pesaro, Pu, Italy, 61122|Roma, Rm, Italy, 00161|Siena, Si, Italy, 53100|Nagoya, Aichi, Japan, 466-8650|Akita, Japan, 010-8543 Kyushu University HospitalFukuoka, Japan, 812-8582 National Hospital Organization Kumamoto Medical Center[Active, Not Recruiting]Kumamoto, Japan, 860-0008 Nagasaki University HospitalNagasaki, Japan, 852-8501 Tokyo Medical University HospitalTokyo, Japan, 160-0023 Korea, Republic Of, Jeollabuk-Do Chonbuk National University Hospital[Active, Not Recruiting]Jeonju-Si, Jeollabuk-Do, Korea, Republic Of, 54907 Korea, Republic Of, Jeollanam-Do Chonnam National University Hwasun HospitalHwasun-Gun, Jeollanam-Do, Korea, Republic Of, 58128 Korea, Republic Of Department Of Pharmacy, Inje University Busan Paik Hospital[Active, Not Recruiting]Busan, Korea, Republic Of, 47392 Inje University Busan Paik Hospital[Active, Not Recruiting]Busan, Korea, Republic Of, 47392 Clinical Trial Pharmacy, Keimyung University Dongsan HospitalDaegu, Korea, Republic Of, 42601 Keimyung University Dongsan HospitalDaegu, Korea, Republic Of, 42601 Gachon University Gil Medical CenterIncheon, Korea, Republic Of, 21565 Seoul National University HospitalSeoul, Korea, Republic Of, 03080 Clinical Trial Center, Severance Hospital, Yonsei University Health SystemSeoul, Korea, Republic Of, 03722 Severance Hospital, Yonsei University Health SystemSeoul, Korea, Republic Of, 03722 Department Of Pharmacy, Samsung Medical CenterSeoul, Korea, Republic Of, 06351 Samsung Medical CenterSeoul, Korea, Republic Of, 06351 Department Of Pharmacy, Severance Hospital, Yonsei University Health SystemSeoul, Korea, Republic Of, 06591 The Catholic University Of Korea Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591 The Catholic University Of Korea, Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591|Yoshida-Gun, Fukui, Japan, 910-1193|Maebashi, Gunma, Japan, 371-8511|Kobe-Shi, Hyogo, Japan, 650-0017|Yokohama, Kanagawa, Japan, 232-0024|Sendai, Miyagi, Japan, 980-8574|Osaka-City, Osaka, Japan, 545-8586 Kindai University HospitalOsaka-Sayama, Osaka, Japan, 589-8511|Sunto-Gun, Shizuoka, Japan, 411-8777|Tachikawa, Tokyo, Japan, 190-0014|MÃ©xico, MÃ©x, Mexico, 14080|Monterrey, Nuevo Leon, Mexico, 64460|Gdansk, Poland, 80-214 Wwcoit Im. M. Kopernika W LodziLodz, Poland, 93-513|Cluj-Napoca, Cluj, Romania, 400124|Craiova, Dolj, Romania, 200136|Bucuresti, Romania, 010825 Spitalul Clinic Coltea, Clinica De HematologieBucuresti, Romania, 030171 Russian Federation Sbhi Cch No. 40 Hd MoscowMoscow, Russian Federation, 129301 State Budgetary Healthcare Institution Of MoscowMoscow, Russian Federation, 129301 Sbhi Nnr Nn Rch N. A. N.A. SemashkoNizhniy Novgorod, Russian Federation, 603126 State Budgetary Institution Of Ryazan Region 'Regional Clinical Hospital' (Sbi Rr Rch)Ryazan, Russian Federation, 390039 Fsbi Russrhti Fmba Of|Barcelona, Spain, 08003 Hospital De La Santa Creu I Sant PauBarcelona, Spain, 08025 Hospital Universitario Arnau De VilanovaLleida, Spain, 25198 Hospital General Universitario Gregorio MaranonMadrid, Spain, 28007 Hospital Universitario Ramon Y CajalMadrid, Spain, 28034 Hospital Universitario Virgen Del RocioSevilla, Spain, 41013 Hospital Universitari I Politecnic La FeValencia, Spain, 46026|Goteborg, Sweden, 413 45 Apl, Apl Sahlgrenska, Kliniska ProvningarGoteborg, Sweden, 413 46 Apoex VnOrebro, Sweden, 701 85 Universitetssjukhuset OrebroOrebro, Sweden, 701 85 Apoex Ab Nks, Kliniska ProvningarSolna, Sweden, 171 64 Karolinska Universitetssjukhuset HuddingeStockholm, Sweden, 141 86 Taiwan National Cheng Kung University HospitalTainan, Taiwan, 704 National Taiwan University HospitalTaipei, Taiwan, 100 Department Of Clinical Trial Pharmacy, Taipei Veterans General HospitalTaipei, Taiwan, 11217 Taipei Veterans General HospitalTaipei, Taiwan, 11217 Division Of Pharmacy, Koo Foundation Sun Yat-Sen Cancer CenterTaipei, Taiwan, 112 Koo Foundation Sun Yat-Sen Cancer CenterTaipei, Taiwan, 112 Chang Gung Memorial Hospital-Linkou BranchTaoyuan City, Taiwan, 333 Chemotherapy Pharmacy, Chang Gung Memorial Hospital-Linkou BranchTaoyuan City, Taiwan, 333|Sutton, Surrey, United Kingdom, Sm2 5Pt|Birmingham, West Midlands, United Kingdom, B15 2Th University Hospitals Birmingham Nhs Foundation TrustBirmingham, West Midlands, United Kingdom, B30 3Hg|London, United Kingdom, Ec1A 7Be Imperial College Healthcare Nhs TrustLondon, United Kingdom, W12 0Hs|Los Angeles, California, United States, 90033 Lac+Usc Medical CenterLos Angeles, California, United States, 90033 Usc/Norris Comprehensive Cancer Center / Investigational Drug ServicesLos Angeles, California, United States, 90033 Usc/Norris Comprehensive Cancer CenterLos Angeles, California, United States, 90033 Rrmc - UclaLos Angeles, California, United States, 90095 Ucla Department Of MedicineLos Angeles, California, United States, 90095 Ucla Drug Information/Investigational DrugsLos Angeles, California, United States, 90095 Ucla Hematology/Oncology ClinicLos Angeles, California, United States, 90095 Ucla Ronald Reagan Medical CenterLos Angeles, California, United States, 90095 Keck Medicine Of Usc Norris Oncology/Hematology - Newport Beach Treatment CenterNewport Beach, California, United States, 92663 Usc Norris Oncology/Hematology - Newport BeachNewport Beach, California, United States, 92663 Uc Irvine Health - Chao Family Comprehensive Cancer CenterOrange, California, United States, 92868-3201 Uc Irvine Medical CenterOrange, California, United States, 92868-3201 Ucsf Helen Diller Family Comprehensive Cancer CenterSan Francisco, California, United States, 94143 University Of California, San Francisco Medical CenterSan Francisco, California, United States, 94143 University Of California, San FranciscoSan Francisco, California, United States, 94143 Ucla Hematology/Oncology - Westlake VillageWestlake Village, California, United States, 91361|Boston, Massachusetts, United States, 02111 Tufts Medical CenterBoston, Massachusetts, United States, 02111 Massachusetts General HospitalBoston, Massachusetts, United States, 02114 Beth|Kansas City, Missouri, United States, 64132|Lake Success, New York, United States, 11042 North Shore University HospitalManhasset, New York, United States, 11030 Long Island Jewish Medical CenterNew Hyde Park, New York, United States, 11040 University Of Rochester Cancer Center PharmacyRochester, New York, United States, 14642 University Of Rochester Medical CenterRochester, New York, United States, 14642|Cleveland, Ohio, United States, 44106 University Hospitals Cleveland Medical CenterCleveland, Ohio, United States, 44106 Cleveland Clinic FoundationCleveland, Ohio, United States, 44195|Portland, Oregon, United States, 97239 Oregon Health & Science University-Research Pharmacy ServicesPortland, Oregon, United States, 97239 Oregon Health & Science UniversityPortland, Oregon, United States, 97239|Nashville, Tennessee, United States, 37203 The Sarah Cannon Research InstituteNashville, Tennessee, United States, 37203 Tristar Bone Marrow TransplantNashville, Tennessee, United States, 37203|Dallas, Texas, United States, 75246 Baylor University Medical CenterDallas, Texas, United States, 75246 Blood Cancer And Stem Cell Transplant ClinicSan Antonio, Texas, United States, 78229 Methodist Healthcare System Of San AntonioSan Antonio, Texas, United States, 78229 Methodist Hospital Investigational PharmacySan Antonio, Texas, United States, 78229|Seattle, Washington, United States, 98104 Swedish First Hill Ids PharmacySeattle, Washington, United States, 98104 Swedish Medical CenterSeattle, Washington, United States, 98122","California|Georgia|Massachusetts|Missouri|New York|Ohio|Oregon|Tennessee|Texas|Washington","Australia|Austria|Belgium|Canada|China|Czechia|France|Georgia|Germany|Greece|Hungary|Israel|Italy|Japan|Mexico|Poland|Romania|Spain|Sweden|United Kingdom|United States","Australia, 5000 Royal Adelaide Hospital|New South Wales St Vincent's Hospital Sydney|Royal Adelaide Hospital - Clinical Trials Pharmacy|Klinikum Wels-Grieskirchen Gmbh|Landeskrankenhaus Salzburg, Universitatsklinik Fur Innere Medizin Iii Der Pmu|Az Sint-Jan Brugge - Oostende Av|Manitoba Health Sciences Centre|Ontario Sunnybrook Research Institute|Quebec Ciusss De L'Est-De-L'Ile-De- MontrÃ©al - HÃ´pital Maisonneuve-Rosemont|Saskatchewan Royal University Hospital|Anhui The First Affiliated Hospital Of Ustc, Anhui Province Hospital|Fujian Fujian Medical University Union Hospital|Guangdong Guangdong Provincial People's Hospital|Hebei Hebei Yanda Lu Daopei Hospital|Henan Henan Provincial People's Hospital/Hematology Department|Hospital, Sichuan University|Hubei Tongji Hospital, Tongji Medical College, Huazhong University Of Science & Technology/Cancer Center|Jiangsu Jiangsu Province Hospital|Peking University People's Hospital|Shanghai Shanghai General Hospital|Shannxi The First Affiliated Hospital Of Xi'An Jiaotong University|Tianjin Institute Of Hematology And Blood Diseases Hospital, Chinese Academy Of Medical Sciences|Zhejiang The First Affiliated Hospital College Of Medicine, Zhejiang University|Interni Hematologicka A Onkologicka Klinika, Fakultni Nemocnice Brno|Chu Henri Mondor|Cancer Center At Augusta University|Bavaria Klinikum Der Universitaet Muenchen|Hesse Philipps-Universitaet Marburg|North Rhine Westphalia UniversitÃ¤tsklinikum KÃ¶ln|North-Rhine-Westphalia Universitaetsklinikum Muenster|Universitaetsklinikum Hamburg-Eppendorf|General Hospital Of Thessaloniki|Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Klinika, Hematologia Tanszek|Deaconess Medical Center|Rambam Health Care Campus|An Sod Farmacia-Dipt Dei Servizi -Aou Ospedali Riuniti Umberto I, G.M. Lancisi, G. Salesi|Ancona Aou Ospedali Riuniti Umberto I, G.M. Lancisi, G. Salesi, Clinica Di Ematologia|Azienda Ospedaliero Universitaria Di Bologna Policlinico S.Orsola Malpighi|Fc Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori|Fe A.O.U. Di Ferrara- Arcispedale Sant'Anna,|Pu Ao Ospedali Riuniti Marche Nord - Presidio Ospedaliero San Salvatore Di Pesaro -|Rm Azienda Ospedaliera Universitaria Umberto I|Si Azienda Ospedaliera Universitaria Senese.|Aichi Japanese Red Cross Nagoya Daini Hospital|Akita University Hospital|Fukui University Of Fukui Hospital|Gunma Gunma University Hospital|Hyogo Kobe University Hospital|Kanagawa Yokohama City University Medical Center|Miyagi Tohoku University Hospital|Osaka Osaka City University Hospital|Shizuoka Shizuoka Cancer Center|Tokyo National Hospital Organization Disaster Medical Center|MÃ©x Instituto Nacional De CancerologÃ­a|Nuevo Leon Hospital Unversitario \"Dr. Jose Eleuterio Gonzalez\"|Klinika Hematologii I Transplantologii Uniwersyteckie Centrum Kliniczne|Cluj Institutul Oncologic 'Prof. Dr. Ion Chiricuta'|Dolj Spitalul Clinic Municipal Filantropia Craiova, Sectia Clinica Hematologie|Spitalul Universitar De Urgenta Militar Central \"Dr. Carol Davila\" Bucuresti|Hospital Del Mar|Sektionen For Hematologi Och Koagulation|, Surrey The Royal Marsden Nhs Foundation Trust|, West Midlands University Hospitals Birmingham Nhs Foundation Trust|Barts Health Nhs Trust|Keck Hospital Of Usc|Augusta University Medical Center Clinical Research Pharmacy|Tufts Medical Center Investigational Pharmacy|Midamerica Division, Inc., C/O Research Medical Center|Northwell Health/Monter Cancer Center|Taussig Cancer Center Investigational Pharmacy|Ohsu Center For Health And Healing|Centennial Medical Center|Baylor Scott And White Research Institute|Swedish Cancer Institute",{"$nulls":3},"Pfizer CT.gov Call Center","2019-12-13","2020-05-25T16:39:40.814","2020-05-26T17:10:42.972","NCT03416179"]
["5ecbf4cc11702c1b1b916bd2","NCT03416179","2020-02-17","Pfizer","PFE","Recruiting","A Study Evaluating Intensive Chemotherapy With or Without Glasdegib or Azacitidine With or Without Glasdegib In Patients With Previously Untreated Acute Myeloid Leukemia (BRIGHT AML1019)","Glasdegib|Cytarabine|Daunorubicin|Azacitidine","Hh Inhibitor|DNA Polymerase Inhibitor|Nucleic Acid Synthesis Inhibitor|TOP2 Inhibitor|DNA Mtase Inhibitor","Unknown",null,"Unknown",null,"Phase 3",4,720,"Anticipated","2018-04-20","2020-12-14","OS","Overall Survival",{"$nulls":3},"Glasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).\n\nGlasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).","Two separate registration trials conducted under one protocol number are proposed to adequately and independently evaluate the addition of glasdegib in intensive and non-intensive chemotherapy populations. Each study will have an experimental treatment arm and a placebo arm. Endpoints are the same for each study except where specifically indicated.\n\nAssignment to the Intensive Study or the Non-Intensive Study will be made by the Investigator based on the 2017 European LeukemiaNet (ELN) recommendations.\n\nStudy B1371019 is a randomized (1:1), double-blind, multi-center, placebo controlled study of chemotherapy in combination with glasdegib versus chemotherapy in combination with placebo in adult patients with previously untreated AML.\n\nGlasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).\n\nGlasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).","A RANDOMIZED (1:1), DOUBLE-BLIND, MULTI-CENTER, PLACEBO CONTROLLED STUDY EVALUATING INTENSIVE CHEMOTHERAPY WITH OR WITHOUT GLASDEGIB (PF-04449913) OR AZACITIDINE (AZA) WITH OR WITHOUT GLASDEGIB IN PATIENTS WITH PREVIOUSLY UNTREATED ACUTE MYELOID LEUKEMIA","B1371019","Leukemia, Myeloid, Acute","Acute Leukemia|Acute Myeloid Leukemia|Myeloid Leukemia|Leukemia","Oncology Hematological","Oncology","Experimental|Placebo Comparator","Arm A (Intensive Study)|Arm B (Intensive Study)|Arm A (Non-intensive study)|Arm B (Non-intensive study)","Glasdegib + '7+3' Induction(s)|Placebo + '7+3' Induction(s)|Glasdegib + azacitidine|Placebo + azacitidine","Drug|Procedure","glasdegib|daunorubicin + cytarabine|cytarabine|HSCT|Placebo|azacitidine","Daily Glasdegib (100 mg, PO), beginning on Day 1 and is to continue up to 2 years post randomization.\n\nFollowing consolidation therapy, glasdegib or placebo will be administered daily for up to 2 years after randomization or until they have minimal residual disease (MRD) negative disease, whichever comes first.\n\nDaily Glasdegib (100 mg, PO) or matching placebo will continue throughout Induction(s) and Consolidation therapies regardless of dose modifications/delays in the chemotherapy.|Consolidation with single agent cytarabine 3 g/m2 IV for adults <60 years and 1 g/m2 for adults 60 years over 3 BID on Days 1, 3, and 5, every 28 days for up to 4 cycles or alternative single agent cytarabine consolidation schedules may be used per local prescribing information.|If required, and done per standard of care post Induction(s).|Azacitidine (75 mg/m2, SC or IV) daily for 7 days, in 28 day cycles for as long as they do not meet the criteria for disease progression, unacceptable toxicity, consent withdrawal, or death.|Matching placebo (PO) is to be administered by mouth daily beginning on Day 1 of chemotherapy and will continue if subjects demonstrate reasonable evidence of clinical benefit and do not meet the criteria for progression regardless of any delays/modifications in the chemotherapy treatment. Subjects will continue placebo until disease progression, unacceptable toxicity, consent withdrawal, or death, whichever comes first.","PF-04449913","Arm A (Intensive Study)|Arm B (Intensive Study)|Arm A (Non-intensive study)|Arm B (Non-intensive study)","\n\nSubjects must meet all of the following inclusion criteria to be eligible for enrollment into the Intensive and Non Intensive study (unless where indicated):\n\n 1.  Subjects with untreated AML according to the World Health Organization (WHO) 2016 Classification2, including those with: * AML arising from MDS or another antecedent hematologic disease (AHD).\n      * AML after previous cytotoxic therapy or radiation (secondary AML).\n     \n     \n 2.  18 years of age (In Japan, 20 years of age).\n 3.  Adequate Organ Function as defined by the following: * Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) 3 x upper limit of normal (ULN), excluding subjects with liver function abnormalities due to underlying malignancy.\n      * Total serum bilirubin 2 x ULN (except subjects with documented Gilbert's syndrome).\n      * Estimated creatinine clearance 30 mL/min as calculated using the standard method for the institution.\n     \n     \n 4.  QTc interval 470 msec using the Fridericia correction (QTcF).\n 5.  All anti cancer treatments (unless specified) should be discontinued 2 weeks from study entry, for example: targeted chemotherapy, radiotherapy, investigational agents, hormones, anagrelide or cytokines. * For control of rapidly progressing leukemia, all trans retinoic acid (ATRA), hydroxyurea, and/or leukopheresis may be used before and for up to 1 week after the first dose of glasdegib.\n     \n     \n 6.  Serum or urine pregnancy test (for female subjects of childbearing potential) with a minimum sensitivity of 25 IU/L or equivalent units of human chorionic gonadotropin (hCG) negative at screening.\n 7.  Male and female subjects of childbearing potential and at risk for pregnancy must agree to use at least one highly effective method of contraception throughout the study and for 180 days after the last dose of azacitidine, cytarabine, or daunorubicin; and the last dose of glasdegib or placebo, whichever occurs later.\n 8.  Female subjects of non childbearing potential must meet at least 1 of the following criteria: 1. Have undergone a documented hysterectomy and/or bilateral oophorectomy;\n      2. Have medically confirmed ovarian failure; or\n      3. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; status may be confirmed by having a serum follicle stimulating hormone (FSH) level confirming the postmenopausal state.\n     \n     All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential.\n     \n     \n 9.  Consent to a saliva sample collection for a germline comparator, unless prohibited by local regulations or ethics committee (EC) decision.\n 10. Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.\n 11. Subjects who are willing and able to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures (including bone marrow [BM] assessments).\n\n","\n\nSubjects with any of the following characteristics/conditions will not be included in the study:\n\n 1.  Acute Promyelocytic Leukemia (APL) and APLwith PML RARA, subjects (WHO 2016 classification).\n 2.  AML with BCR ABL1 or t(9;22)(q34;q11.2) as a sole abnormality. * Complex genetics may include t(9;22) cytogenetic translocation.\n     \n     \n 3.  Subjects with known active CNS leukemia.\n 4.  Participation in other clinical studies involving other investigational drug(s) (Phases 1 4) within 4 weeks prior study entry and/or during study participation.\n 5.  Subjects known to be refractory to platelet or packed red cell transfusions per Institutional Guidelines, or a patient who refuses blood product support.\n 6.  Subjects with another active malignancy on treatment with the exception of basal cell carcinoma, non melanoma skin cancer, cervical carcinoma in situ. Other prior or concurrent malignancies will be considered on a case by case basis.\n 7.  Any one of the following ongoing or in the previous 6 months: myocardial infarction, congenital long QT syndrome, Torsades de pointes, symptomatic arrhythmias (including sustained ventricular tachyarrhythmia), right or left bundle branch block and bifascicular block, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (CHF New York Heart Association class III or IV), cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism; as well as bradycardia defined as <50 bpms.\n 8.  Subjects with an active, life threatening or clinically significant uncontrolled systemic infection not related to AML.\n 9.  Subjects with left ventricular ejection fraction (LVEF) <50% are excluded from the Intensive Chemotherapy Study only.\n 10. Cumulative anthracycline dose equivalent of 550 mg/m2 of daunorubicin for the Intensive Chemotherapy Study only.\n 11. Known malabsorption syndrome or other condition that may significantly impair absorption of study medication in the investigator's judgment (eg, gastrectomy, lap band, Crohn's disease) and inability or unwillingness to swallow tablets or capsules.\n 12. Current use or anticipated requirement for drugs that are known strong CYP3A4/5 inducers.\n 13. Concurrent administration of herbal preparations.\n 14. Major surgery or radiation within 4 weeks of starting study treatment.\n 15. Documented or suspected hypersensitivity to any one of the following: * For subjects assigned to intensive chemotherapy, documented or suspected hypersensitivity to cytarabine (not including drug fever or exanthema, including known cerebellar side effects) or daunorubicin.\n      * For subjects assigned to non intensive chemotherapy, documented or suspected hypersensitivity to azacitidine or mannitol.\n     \n     \n 16. Known active drug or alcohol abuse.\n 17. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.\n 18. Pregnant females or breastfeeding female subjects.\n 19. Known recent or active suicidal ideation or behavior.\n 20. Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.","FSH",null,"Protein","Ovary","Actual","2018-01-31","Actual","Anticipated","2025-02-12","Anticipated","2020-02-01","2017-12-21","2018-01-23","2020-02-13","Yes","glasdegib;\nuntreated;\nHedgehog Inhibitor","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"All",null,"No","Yes\nPfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",null,"URL: https://pmiform.com/clinical-trial-info-request?StudyID=B1371019 [https://pmiform.com/clinical-trial-info-request?StudyID=B1371019] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To obtain contact information for a study center near you, click here.",null,"Yes","No",{"$nulls":17},"2017-002822-19|BRIGHT|BRIGHT AML1019","EudraCT Number|Alias Study Number","Overall survival","5 years after last subject randomized",null,"Fatigue score measured by the MD Anderson Symptom Inventory (MDASI)-AML/MDS questionnaire|Rate of Complete Remission (CR) (including CR with minimal residual disease (MRD)-negative as assessed by multiparametric flow cytometry)|Duration of response (defined as CR [includes CR-MRD negative]/CRi or CR/CRh as appropriate)|Time to response (CR[includes CR-MRD negative)]/CR with partial hematologic rcovery (CRh) as appropriate)|Event-free Survival|Patient Reported Outcomes (PROs) as measured by the M.D. Anderson Symptom Inventory AML/MDS Module (MDASI-AML/MDS)|Adverse events as graded by NCI CTCAE v4.03|Laboratory abnormalities as graded by NCI CTCAE v4.03|For the intensive study, the plasma trough concentration (Ctrough) will be analyzed|QTc interval|PROs as measured by Patient Global Impression of Change (PGIC)|Patient Reported Outcomes (PROs) as measured by EuroQoL 5 Dimension questionnaire 5-Level version (EQ-5D-5L)|Patient Reported Outcomes (PROs) as measured by Patient Global Impression of Symptoms (PGIS)|Complete Remission with incomplete hematologic recovery (CRi)|Rate of morphological leukemia-free state (MLFS)|Rate of Partial Remission (PR)|Rate of Complete Remission with partial hematological recovery (CRh) for the Non-intensive study only only|Minimum Observed Plasma Trough Concentratrion of glasdegib in the Intensive Study|Minimum Observed Plasma Trough Concentration of glasdegib in the Non-intensive study","Scale is from 0-10 where 0 is not present and 10 is as bad as you can image.|Response as defined by the 2017 European LeukemiaNet (ELN) recommendations.|5 years after last subject randomized, consent withdrawal, or death|Measurement Scale from 0-10.|PK samples taken on Induction(s) Day 1 (1 and 4 hours post induction); Induction(s) Day 10 (pre-dose, 1 and 4 hours post dose); Day 1 of each Consolidation cycle (pre-dose, 1 and 4 hours post dose)|One question asking for description of leukemia symptoms.|Series of questions that ask for information that best describes health.|One question asking for information regarding leukemia symptoms.|Its the minimum trough concentration in plasma of glasdegib following multiple daily dosing to steady state.|It is the minimum trough concentration in plasma of glasdegib following multiple daily dosing to steady state.","5 years after last subject randomized, consent withdrawal, or death|2 years after last dose of study therapy|5 years after last patient randomized, withdrawal, or death|5 years after last subject randomized, withdrawal, or death|Day 10 of Induction Cycle and Day 1 of each Consolidation Cycle|Cycle 1 Day 15 and Cycles 2 and 3 on Day 1","ClinicalTrials.gov_Inquiries@pfizer.com","Pfizer CT.gov Call Center","1-800-718-1021","Adelaide, South|Darlinghurst, New South Wales, Australia, 2010 St George HospitalKogarah, New South Wales, Australia, 2217|Wels, Upper|Salzburg, Austria, 5020 Uniklinikum Salzburg, Landeskrankenhaus SalzburgSalzburg, Austria, 5020 Klinikum Wels-Grieskirchen GmbhWels, Austria, 4600 Sozialmedizinisches Zentrum Sud.Wien, Austria, 1100 Krankenhaus Hietzing Mit Neurologischem Zentrum RosenhugelWien, Austria, 1130|Brugge, Belgium, B-8000 Az Sint-Jan Brugge-Oostende AvBrugge, Belgium, B-8000 Universitaire Ziekenhuizen Brussel (Uz Brussel)Brussels, Belgium, B-1090 Universitaire Ziekenhuizen BrusselBrussels, Belgium, B-1090 Universitaire Ziekenhuizen LeuvenLeuven, Belgium, B-3000|Winnipeg, Manitoba, Canada, R3A 1R9 Cancercare ManitobaWinnipeg, Manitoba, Canada, R3E 0V9|Toronto, Ontario, Canada, M4N 3M5 Princess Margaret Cancer CentreToronto, Ontario, Canada, M5G 2M9|Montreal, Quebec, Canada, H1T 2M4|Saskatoon, Saskatchewan, Canada, S7N 0W8 Saskatoon Cancer CentreSaskatoon, Saskatchewan, Canada, S7N 4H4|Hefei, Anhui, China, 230001 Anhui Provincial HospitalHefei, Anhui, China, 230071|Fuzhou, Fujian, China, 350001|Guangzhou, Guangdong, China, 510080 Guangdong Second Provincial General HospitalGuangzhou, Guangdong, China, 510317|[Active, Not Recruiting]Langfang, Hebei, China, 065201|Zhengzhou, Henan, China, 450003 Henan Cancer HostipalZhengzhou, Henan, China, 450008|Chengdu, Sichuan, China, 610041|Wuhan, Hubei, China, 430030|Nanjing, Jiangsu, China, 210029|Beijing, China, 100044 Ruijin Hospital Affiliated To Shanghai Jiaotong University School Of MedicineShanghai, China, 200025|Shanghai, Shanghai, China, 200080|Xi'An, Shannxi, China, 710061|Tianjin, Tianjin, China, 300020|Hangzhou, Zhejiang, China, 310003|Brno, Czechia, 100 34 Nemocnicni LekarnaBrno, Czechia, 625 00 Ustavni LekarnaOstrava - Poruba, Czechia, 708 52 Klinika HematoonkologieOstrava-Poruba, Czechia, 708 52 InternÃ­ HematologickÃ¡ Klinika, Fakultni Nemocnice KrÃ¡lovskÃ© VinohradyPraha 10, Czechia, 100 34 Ãšstavni LÃ©kÃ¡rnaPraha 10, Czechia, 100 34|Creteil, France, 94010 Chu Henri MondorCrÃ©teil, France, 94010 Chu De NantesNantes Cedex 1, France, 44093 Chu De Nantes Hotel DieuNantes Cedex, France, 44093 Hopital Saint LouisParis, France, 75010 Centre Hospitalier Lyon Sud - Service D'HematologiePierre Benite Cedex, France, 69495 Centre Hospitalier Lyon Sud -Unite De Pharmacie Clinique OncologiquePierre Benite Cedex, France, 69495 Institut Gustave RoussyVillejuif Cedex, France, 94805|Augusta, Georgia, United States, 30912|Munich, Bavaria, Germany, 81377|Marburg, Hesse, Germany, 35032|Koeln, North Rhine Westphalia, Germany, 50937|Muenster, North Rhine-Westphalia, Germany, 48149|Muenster, North-Rhine-Westphalia, Germany, 48149|Hamburg, Germany, 20246 Medizinische Hochschule HannoverHannover, Germany, 30625|Thessaloniki, Greece, 57010|Debrecen, Hungary, 4032 Debreceni Egyetem Klinikai Kozpont Belgyogyaszati KlinikaDebrecen, Hungary, 4032 Petz AladÃ¡r Megyei OktatÃ³ KÃ³rhÃ¡z, GyÃ³gyszerÃ©szeti OsztÃ¡lyGyÅ‘r, Hungary, 9024 Petz AladÃ¡r Megyei OktatÃ³ KÃ³rhÃ¡z, Ii. BelgyÃ³gyÃ¡szat- HematolÃ³giai OsztÃ¡lyGyÅ‘r, Hungary, 9024 Somogy Megyei Kaposi Mor Oktato KorhazKaposvar, Hungary, 7400 Szabolcs-Szatmar Bereg Megyei Korhazak Es Egyetemi Oktatokorhaz, Josa Andras Korhaz, HematologiaNyiregyhaza, Hungary, 4400 Szabolcs-Szatmar Bereg Megyei Korhazak Es Egyetemi Oktatokorhaz, Josa Andras Korhaz,Nyiregyhaza, Hungary, 4400|Haifa, Israel, 3109601 Shaare Zedek Medical CenterJerusalem, Israel, 9103102 Hadassah Medical Center (Ein Kerem)Jerusalem, Israel, 91120 Hemato-Oncology Ambulatory ServicePetah Tikva, Israel, 4941492 Hematology Division - Oncology PharmacyPetah Tikva, Israel, 4941492 Rabin Medical Center, Beilinson HospitalPetah Tikva, Israel, 4941492 Tel-Aviv Sourasky Medical CenterTel Aviv, Israel, 6423906|Torette Di Ancona, An, Italy, 60126|Torrette Di Ancona, Ancona, Italy, 60126|Bologna, Italy, 40138 Azienda Ospedaliera Universitaria SeneseSiena, Italy, 53100|Meldola, Fc, Italy, 47014|Cona, Ferrara, Fe, Italy, 44124 Farmacia OspedalieraFerrara, Fe, Italy, 44121|Pesaro, Pu, Italy, 61122|Roma, Rm, Italy, 00161|Siena, Si, Italy, 53100|Nagoya, Aichi, Japan, 466-8650|Akita, Japan, 010-8543 Kyushu University HospitalFukuoka, Japan, 812-8582 National Hospital Organization Kumamoto Medical Center[Active, Not Recruiting]Kumamoto, Japan, 860-0008 Nagasaki University HospitalNagasaki, Japan, 852-8501 Tokyo Medical University HospitalTokyo, Japan, 160-0023 Korea, Republic Of, Jeollabuk-Do Chonbuk National University Hospital[Active, Not Recruiting]Jeonju-Si, Jeollabuk-Do, Korea, Republic Of, 54907 Korea, Republic Of, Jeollanam-Do Chonnam National University Hwasun HospitalHwasun-Gun, Jeollanam-Do, Korea, Republic Of, 58128 Korea, Republic Of Department Of Pharmacy, Inje University Busan Paik Hospital[Active, Not Recruiting]Busan, Korea, Republic Of, 47392 Inje University Busan Paik Hospital[Active, Not Recruiting]Busan, Korea, Republic Of, 47392 Clinical Trial Pharmacy, Keimyung University Dongsan Hospital[Active, Not Recruiting]Daegu, Korea, Republic Of, 42601 Keimyung University Dongsan Hospital[Active, Not Recruiting]Daegu, Korea, Republic Of, 42601 Gachon University Gil Medical CenterIncheon, Korea, Republic Of, 21565 Seoul National University HospitalSeoul, Korea, Republic Of, 03080 Clinical Trial Center, Severance Hospital, Yonsei University Health SystemSeoul, Korea, Republic Of, 03722 Severance Hospital, Yonsei University Health SystemSeoul, Korea, Republic Of, 03722 Department Of Pharmacy, Samsung Medical CenterSeoul, Korea, Republic Of, 06351 Samsung Medical CenterSeoul, Korea, Republic Of, 06351 Department Of Pharmacy, Severance Hospital, Yonsei University Health SystemSeoul, Korea, Republic Of, 06591 The Catholic University Of Korea Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591 The Catholic University Of Korea, Seoul St. Mary'S HospitalSeoul, Korea, Republic Of, 06591|Yoshida-Gun, Fukui, Japan, 910-1193|Maebashi, Gunma, Japan, 371-8511|Kobe-Shi, Hyogo, Japan, 650-0017|Yokohama, Kanagawa, Japan, 232-0024|Sendai, Miyagi, Japan, 980-8574|Osaka-City, Osaka, Japan, 545-8586 Kindai University HospitalOsaka-Sayama, Osaka, Japan, 589-8511|Sunto-Gun, Shizuoka, Japan, 411-8777|Tachikawa, Tokyo, Japan, 190-0014|MÃ©xico, MÃ©x, Mexico, 14080|Monterrey, Nuevo Leon, Mexico, 64460|Gdansk, Poland, 80-214 Wwcoit Im. M. Kopernika W Lodzi[Active, Not Recruiting]Lodz, Poland, 93-513|Cluj-Napoca, Cluj, Romania, 400124|Craiova, Dolj, Romania, 200136|Bucuresti, Romania, 010825 Spitalul Clinic Coltea, Clinica De HematologieBucuresti, Romania, 030171 Russian Federation Sbhi Cch No. 40 Hd MoscowMoscow, Russian Federation, 129301 State Budgetary Healthcare Institution Of MoscowMoscow, Russian Federation, 129301 Sbhi Nnr Nn Rch N. A. N.A. SemashkoNizhniy Novgorod, Russian Federation, 603126 State Budgetary Institution Of Ryazan Region 'Regional Clinical Hospital' (Sbi Rr Rch)Ryazan, Russian Federation, 390039 Fsbi Russrhti Fmba Of|Barcelona, Spain, 08003 Hospital De La Santa Creu I Sant PauBarcelona, Spain, 08025 Hospital Universitario Arnau De VilanovaLleida, Spain, 25198 Hospital General Universitario Gregorio MaranonMadrid, Spain, 28007 Hospital Universitario Ramon Y CajalMadrid, Spain, 28034 Hospital Universitario Virgen Del RocioSevilla, Spain, 41013 Hospital Universitari I Politecnic La FeValencia, Spain, 46026|Goteborg, Sweden, 413 45 Apl, Apl Sahlgrenska, Kliniska ProvningarGoteborg, Sweden, 413 46 Apoex VnOrebro, Sweden, 701 85 Universitetssjukhuset OrebroOrebro, Sweden, 701 85 Apoex Ab Nks, Kliniska ProvningarSolna, Sweden, 171 64 Karolinska Universitetssjukhuset HuddingeStockholm, Sweden, 141 86 Taiwan National Cheng Kung University HospitalTainan, Taiwan, 704 National Taiwan University HospitalTaipei, Taiwan, 100 Department Of Clinical Trial Pharmacy, Taipei Veterans General HospitalTaipei, Taiwan, 11217 Taipei Veterans General HospitalTaipei, Taiwan, 11217 Division Of Pharmacy, Koo Foundation Sun Yat-Sen Cancer CenterTaipei, Taiwan, 112 Koo Foundation Sun Yat-Sen Cancer CenterTaipei, Taiwan, 112 Chang Gung Memorial Hospital-Linkou BranchTaoyuan City, Taiwan, 333 Chemotherapy Pharmacy, Chang Gung Memorial Hospital-Linkou BranchTaoyuan City, Taiwan, 333|Sutton, Surrey, United Kingdom, Sm2 5Pt|Birmingham, West Midlands, United Kingdom, B15 2Th University Hospitals Birmingham Nhs Foundation TrustBirmingham, West Midlands, United Kingdom, B30 3Hg|London, United Kingdom, Ec1A 7Be Imperial College Healthcare Nhs TrustLondon, United Kingdom, W12 0Hs|Los Angeles, California, United States, 90095 Ucla Department Of MedicineLos Angeles, California, United States, 90095 Ucla Drug Information/Investigational DrugsLos Angeles, California, United States, 90095 Ucla Hematology/Oncology ClinicLos Angeles, California, United States, 90095 Ucla Ronald Reagan Medical CenterLos Angeles, California, United States, 90095 Uc Irvine Health - Chao Family Comprehensive Cancer CenterOrange, California, United States, 92868-3201 Uc Irvine Medical CenterOrange, California, United States, 92868-3201 Ucsf Helen Diller Family Comprehensive Cancer CenterSan Francisco, California, United States, 94143 University Of California, San Francisco Medical CenterSan Francisco, California, United States, 94143 University Of California, San FranciscoSan Francisco, California, United States, 94143 Ucla Hematology/Oncology - Westlake VillageWestlake Village, California, United States, 91361|Boston, Massachusetts, United States, 02111 Tufts Medical CenterBoston, Massachusetts, United States, 02111 Massachusetts General HospitalBoston, Massachusetts, United States, 02114|Kansas City, Missouri, United States, 64132|Lake Success, New York, United States, 11042 North Shore University HospitalManhasset, New York, United States, 11030 Long Island Jewish Medical CenterNew Hyde Park, New York, United States, 11040 University Of Rochester Cancer Center PharmacyRochester, New York, United States, 14642 University Of Rochester Medical CenterRochester, New York, United States, 14642|Cleveland, Ohio, United States, 44106 University Hospitals Cleveland Medical CenterCleveland, Ohio, United States, 44106 Cleveland Clinic FoundationCleveland, Ohio, United States, 44195|Portland, Oregon, United States, 97239 Oregon Health & Science University-Research Pharmacy ServicesPortland, Oregon, United States, 97239 Oregon Health & Science UniversityPortland, Oregon, United States, 97239|Nashville, Tennessee, United States, 37203 The Sarah Cannon Research InstituteNashville, Tennessee, United States, 37203 Tristar Bone Marrow TransplantNashville, Tennessee, United States, 37203|Dallas, Texas, United States, 75246 Baylor University Medical CenterDallas, Texas, United States, 75246 Blood Cancer And Stem Cell Transplant ClinicSan Antonio, Texas, United States, 78229 Methodist Healthcare System Of San AntonioSan Antonio, Texas, United States, 78229 Methodist Hospital Investigational PharmacySan Antonio, Texas, United States, 78229|Seattle, Washington, United States, 98104 Swedish First Hill Ids PharmacySeattle, Washington, United States, 98104 Swedish Medical CenterSeattle, Washington, United States, 98122","California|Georgia|Massachusetts|Missouri|New York|Ohio|Oregon|Tennessee|Texas|Washington","Australia|Austria|Belgium|Canada|China|Czechia|France|Georgia|Germany|Greece|Hungary|Israel|Italy|Japan|Mexico|Poland|Romania|Spain|Sweden|United Kingdom|United States","Australia, 5000 Royal Adelaide Hospital|New South Wales St Vincent's Hospital Sydney|Royal Adelaide Hospital - Clinical Trials Pharmacy|Klinikum Wels-Grieskirchen Gmbh|Landeskrankenhaus Salzburg, Universitatsklinik Fur Innere Medizin Iii Der Pmu|Az Sint-Jan Brugge - Oostende Av|Manitoba Health Sciences Centre|Ontario Sunnybrook Research Institute|Quebec Ciusss De L'Est-De-L'Ile-De- MontrÃ©al - HÃ´pital Maisonneuve-Rosemont|Saskatchewan Royal University Hospital|Anhui The First Affiliated Hospital Of Ustc, Anhui Province Hospital|Fujian Fujian Medical University Union Hospital|Guangdong Guangdong Provincial People's Hospital|Hebei Hebei Yanda Lu Daopei Hospital|Henan Henan Provincial People's Hospital/Hematology Department|Hospital, Sichuan University|Hubei Tongji Hospital, Tongji Medical College, Huazhong University Of Science & Technology/Cancer Center|Jiangsu Jiangsu Province Hospital|Peking University People's Hospital|Shanghai Shanghai General Hospital|Shannxi The First Affiliated Hospital Of Xi'An Jiaotong University|Tianjin Institute Of Hematology And Blood Diseases Hospital, Chinese Academy Of Medical Sciences|Zhejiang The First Affiliated Hospital College Of Medicine, Zhejiang University|Interni Hematologicka A Onkologicka Klinika, Fakultni Nemocnice Brno|Chu Henri Mondor|Cancer Center At Augusta University|Bavaria Klinikum Der Universitaet Muenchen|Hesse Philipps-Universitaet Marburg|North Rhine Westphalia UniversitÃ¤tsklinikum KÃ¶ln|North Rhine-Westphalia Universitaetsklinikum Muenster|North-Rhine-Westphalia Universitaetsklinikum Muenster|Universitaetsklinikum Hamburg-Eppendorf|General Hospital Of Thessaloniki|Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Klinika, Hematologia Tanszek|Rambam Health Care Campus|An Sod Farmacia-Dipt Dei Servizi -Aou Ospedali Riuniti Umberto I, G.M. Lancisi, G. Salesi|Ancona Aou Ospedali Riuniti Umberto I, G.M. Lancisi, G. Salesi, Clinica Di Ematologia|Azienda Ospedaliero Universitaria Di Bologna Policlinico S.Orsola Malpighi|Fc Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori|Fe A.O.U. Di Ferrara- Arcispedale Sant'Anna,|Pu Ao Ospedali Riuniti Marche Nord - Presidio Ospedaliero San Salvatore Di Pesaro -|Rm Azienda Ospedaliera Universitaria Umberto I|Si Azienda Ospedaliera Universitaria Senese.|Aichi Japanese Red Cross Nagoya Daini Hospital|Akita University Hospital|Fukui University Of Fukui Hospital|Gunma Gunma University Hospital|Hyogo Kobe University Hospital|Kanagawa Yokohama City University Medical Center|Miyagi Tohoku University Hospital|Osaka Osaka City University Hospital|Shizuoka Shizuoka Cancer Center|Tokyo National Hospital Organization Disaster Medical Center|MÃ©x Instituto Nacional De CancerologÃ­a|Nuevo Leon Hospital Unversitario \"Dr. Jose Eleuterio Gonzalez\"|Klinika Hematologii I Transplantologii Uniwersyteckie Centrum Kliniczne|Cluj Institutul Oncologic 'Prof. Dr. Ion Chiricuta'|Dolj Spitalul Clinic Municipal Filantropia Craiova, Sectia Clinica Hematologie|Spitalul Universitar De Urgenta Militar Central \"Dr. Carol Davila\" Bucuresti|Hospital Del Mar|Sektionen For Hematologi Och Koagulation|, Surrey The Royal Marsden Nhs Foundation Trust|, West Midlands University Hospitals Birmingham Nhs Foundation Trust|Barts Health Nhs Trust|Rrmc - Ucla|Augusta University Medical Center Clinical Research Pharmacy|Tufts Medical Center Investigational Pharmacy|Midamerica Division, Inc., C/O Research Medical Center|Northwell Health/Monter Cancer Center|Taussig Cancer Center Investigational Pharmacy|Ohsu Center For Health And Healing|Centennial Medical Center|Baylor Scott And White Research Institute|Swedish Cancer Institute",{"$nulls":3},"Pfizer CT.gov Call Center","2020-02-13","2020-05-25T16:39:40.827","2020-05-26T17:10:42.972","NCT03416179"]
["5ecbf4cdfeab101b155309f5","NCT03416179","2020-04-09","Pfizer","PFE","Recruiting","A Study Evaluating Intensive Chemotherapy With or Without Glasdegib or Azacitidine With or Without Glasdegib In Patients With Previously Untreated Acute Myeloid Leukemia (BRIGHT AML1019)","Glasdegib|Cytarabine|Daunorubicin|Azacitidine","Hh Inhibitor|DNA Polymerase Inhibitor|Nucleic Acid Synthesis Inhibitor|TOP2 Inhibitor|DNA Mtase Inhibitor","Unknown",null,"Unknown",null,"Phase 3",4,720,"Anticipated","2018-04-20","2020-12-14","OS","Overall Survival",{"$nulls":3},"Glasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).\n\nGlasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).","Two separate registration trials conducted under one protocol number are proposed to adequately and independently evaluate the addition of glasdegib in intensive and non-intensive chemotherapy populations. Each study will have an experimental treatment arm and a placebo arm. Endpoints are the same for each study except where specifically indicated.\n\nAssignment to the Intensive Study or the Non-Intensive Study will be made by the Investigator based on the 2017 European LeukemiaNet (ELN) recommendations.\n\nStudy B1371019 is a randomized (1:1), double-blind, multi-center, placebo controlled study of chemotherapy in combination with glasdegib versus chemotherapy in combination with placebo in adult patients with previously untreated AML.\n\nGlasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).\n\nGlasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).","A RANDOMIZED (1:1), DOUBLE-BLIND, MULTI-CENTER, PLACEBO CONTROLLED STUDY EVALUATING INTENSIVE CHEMOTHERAPY WITH OR WITHOUT GLASDEGIB (PF-04449913) OR AZACITIDINE (AZA) WITH OR WITHOUT GLASDEGIB IN PATIENTS WITH PREVIOUSLY UNTREATED ACUTE MYELOID LEUKEMIA","B1371019","Leukemia, Myeloid, Acute","Acute Leukemia|Acute Myeloid Leukemia|Myeloid Leukemia|Leukemia","Oncology Hematological","Oncology","Experimental|Placebo Comparator","Arm A (Intensive Study)|Arm B (Intensive Study)|Arm A (Non-intensive study)|Arm B (Non-intensive study)","Glasdegib + '7+3' Induction(s)|Placebo + '7+3' Induction(s)|Glasdegib + azacitidine|Placebo + azacitidine","Drug|Procedure","glasdegib|daunorubicin + cytarabine|cytarabine|HSCT|Placebo|azacitidine","Daily Glasdegib (100 mg, PO), beginning on Day 1 and is to continue up to 2 years post randomization.\n\nFollowing consolidation therapy, glasdegib or placebo will be administered daily for up to 2 years after randomization or until they have minimal residual disease (MRD) negative disease, whichever comes first.\n\nDaily Glasdegib (100 mg, PO) or matching placebo will continue throughout Induction(s) and Consolidation therapies regardless of dose modifications/delays in the chemotherapy.|Consolidation with single agent cytarabine 3 g/m2 IV for adults <60 years and 1 g/m2 for adults 60 years over 3 BID on Days 1, 3, and 5, every 28 days for up to 4 cycles or alternative single agent cytarabine consolidation schedules may be used per local prescribing information.|If required, and done per standard of care post Induction(s).|Azacitidine (75 mg/m2, SC or IV) daily for 7 days, in 28 day cycles for as long as they do not meet the criteria for disease progression, unacceptable toxicity, consent withdrawal, or death.|Matching placebo (PO) is to be administered by mouth daily beginning on Day 1 of chemotherapy and will continue if subjects demonstrate reasonable evidence of clinical benefit and do not meet the criteria for progression regardless of any delays/modifications in the chemotherapy treatment. Subjects will continue placebo until disease progression, unacceptable toxicity, consent withdrawal, or death, whichever comes first.","PF-04449913","Arm A (Intensive Study)|Arm B (Intensive Study)|Arm A (Non-intensive study)|Arm B (Non-intensive study)","\n\nSubjects must meet all of the following inclusion criteria to be eligible for enrollment into the Intensive and Non Intensive study (unless where indicated):\n\n 1.  Subjects with untreated AML according to the World Health Organization (WHO) 2016 Classification2, including those with: * AML arising from MDS or another antecedent hematologic disease (AHD).\n      * AML after previous cytotoxic therapy or radiation (secondary AML).\n     \n     \n 2.  18 years of age (In Japan, 20 years of age).\n 3.  Adequate Organ Function as defined by the following: * Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) 3 x upper limit of normal (ULN), excluding subjects with liver function abnormalities due to underlying malignancy.\n      * Total serum bilirubin 2 x ULN (except subjects with documented Gilbert's syndrome).\n      * Estimated creatinine clearance 30 mL/min as calculated using the standard method for the institution.\n     \n     \n 4.  QTc interval 470 msec using the Fridericia correction (QTcF).\n 5.  All anti cancer treatments (unless specified) should be discontinued 2 weeks from study entry, for example: targeted chemotherapy, radiotherapy, investigational agents, hormones, anagrelide or cytokines. * For control of rapidly progressing leukemia, all trans retinoic acid (ATRA), hydroxyurea, and/or leukopheresis may be used before and for up to 1 week after the first dose of glasdegib.\n     \n     \n 6.  Serum or urine pregnancy test (for female subjects of childbearing potential) with a minimum sensitivity of 25 IU/L or equivalent units of human chorionic gonadotropin (hCG) negative at screening.\n 7.  Male and female subjects of childbearing potential and at risk for pregnancy must agree to use at least one highly effective method of contraception throughout the study and for 180 days after the last dose of azacitidine, cytarabine, or daunorubicin; and the last dose of glasdegib or placebo, whichever occurs later.\n 8.  Female subjects of non childbearing potential must meet at least 1 of the following criteria: 1. Have undergone a documented hysterectomy and/or bilateral oophorectomy;\n      2. Have medically confirmed ovarian failure; or\n      3. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; status may be confirmed by having a serum follicle stimulating hormone (FSH) level confirming the postmenopausal state.\n     \n     All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential.\n     \n     \n 9.  Consent to a saliva sample collection for a germline comparator, unless prohibited by local regulations or ethics committee (EC) decision.\n 10. Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.\n 11. Subjects who are willing and able to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures (including bone marrow [BM] assessments).\n\n","\n\nSubjects with any of the following characteristics/conditions will not be included in the study:\n\n 1.  Acute Promyelocytic Leukemia (APL) and APLwith PML RARA, subjects (WHO 2016 classification).\n 2.  AML with BCR ABL1 or t(9;22)(q34;q11.2) as a sole abnormality. * Complex genetics may include t(9;22) cytogenetic translocation.\n     \n     \n 3.  Subjects with known active CNS leukemia.\n 4.  Participation in other clinical studies involving other investigational drug(s) (Phases 1 4) within 4 weeks prior study entry and/or during study participation.\n 5.  Subjects known to be refractory to platelet or packed red cell transfusions per Institutional Guidelines, or a patient who refuses blood product support.\n 6.  Subjects with another active malignancy on treatment with the exception of basal cell carcinoma, non melanoma skin cancer, cervical carcinoma in situ. Other prior or concurrent malignancies will be considered on a case by case basis.\n 7.  Any one of the following ongoing or in the previous 6 months: myocardial infarction, congenital long QT syndrome, Torsades de pointes, symptomatic arrhythmias (including sustained ventricular tachyarrhythmia), right or left bundle branch block and bifascicular block, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (CHF New York Heart Association class III or IV), cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism; as well as bradycardia defined as <50 bpms.\n 8.  Subjects with an active, life threatening or clinically significant uncontrolled systemic infection not related to AML.\n 9.  Subjects with left ventricular ejection fraction (LVEF) <50% are excluded from the Intensive Chemotherapy Study only.\n 10. Cumulative anthracycline dose equivalent of 550 mg/m2 of daunorubicin for the Intensive Chemotherapy Study only.\n 11. Known malabsorption syndrome or other condition that may significantly impair absorption of study medication in the investigator's judgment (eg, gastrectomy, lap band, Crohn's disease) and inability or unwillingness to swallow tablets or capsules.\n 12. Current use or anticipated requirement for drugs that are known strong CYP3A4/5 inducers.\n 13. Concurrent administration of herbal preparations.\n 14. Major surgery or radiation within 4 weeks of starting study treatment.\n 15. Documented or suspected hypersensitivity to any one of the following: * For subjects assigned to intensive chemotherapy, documented or suspected hypersensitivity to cytarabine (not including drug fever or exanthema, including known cerebellar side effects) or daunorubicin.\n      * For subjects assigned to non intensive chemotherapy, documented or suspected hypersensitivity to azacitidine or mannitol.\n     \n     \n 16. Known active drug or alcohol abuse.\n 17. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.\n 18. Pregnant females or breastfeeding female subjects.\n 19. Known recent or active suicidal ideation or behavior.\n 20. Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.","FSH",null,"Protein","Ovary","Actual","2018-01-31","Actual","Anticipated","2025-02-12","Anticipated","2020-04-01","2017-12-21","2018-01-23","2020-04-07","Yes","glasdegib;\nuntreated;\nHedgehog Inhibitor","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"All",null,"No","Yes\nPfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",null,"URL: https://pmiform.com/clinical-trial-info-request?StudyID=B1371019 [https://pmiform.com/clinical-trial-info-request?StudyID=B1371019] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To obtain contact information for a study center near you, click here.",null,"Yes","No",{"$nulls":17},"2017-002822-19|BRIGHT|BRIGHT AML1019","EudraCT Number|Alias Study Number","Overall survival","5 years after last subject randomized",null,"Fatigue score measured by the MD Anderson Symptom Inventory (MDASI)-AML/MDS questionnaire|Rate of Complete Remission (CR) (including CR with minimal residual disease (MRD)-negative as assessed by multiparametric flow cytometry)|Duration of response (defined as CR [includes CR-MRD negative]/CRi or CR/CRh as appropriate)|Time to response (CR[includes CR-MRD negative)]/CR with partial hematologic rcovery (CRh) as appropriate)|Event-free Survival|Patient Reported Outcomes (PROs) as measured by the M.D. Anderson Symptom Inventory AML/MDS Module (MDASI-AML/MDS)|Adverse events as graded by NCI CTCAE v4.03|Laboratory abnormalities as graded by NCI CTCAE v4.03|For the intensive study, the plasma trough concentration (Ctrough) will be analyzed|QTc interval|PROs as measured by Patient Global Impression of Change (PGIC)|Patient Reported Outcomes (PROs) as measured by EuroQoL 5 Dimension questionnaire 5-Level version (EQ-5D-5L)|Patient Reported Outcomes (PROs) as measured by Patient Global Impression of Symptoms (PGIS)|Complete Remission with incomplete hematologic recovery (CRi)|Rate of morphological leukemia-free state (MLFS)|Rate of Partial Remission (PR)|Rate of Complete Remission with partial hematological recovery (CRh) for the Non-intensive study only only|Minimum Observed Plasma Trough Concentratrion of glasdegib in the Intensive Study|Minimum Observed Plasma Trough Concentration of glasdegib in the Non-intensive study","Scale is from 0-10 where 0 is not present and 10 is as bad as you can image.|Response as defined by the 2017 European LeukemiaNet (ELN) recommendations.|5 years after last subject randomized, consent withdrawal, or death|Measurement Scale from 0-10.|PK samples taken on Induction(s) Day 1 (1 and 4 hours post induction); Induction(s) Day 10 (pre-dose, 1 and 4 hours post dose); Day 1 of each Consolidation cycle (pre-dose, 1 and 4 hours post dose)|One question asking for description of leukemia symptoms.|Series of questions that ask for information that best describes health.|One question asking for information regarding leukemia symptoms.|Its the minimum trough concentration in plasma of glasdegib following multiple daily dosing to steady state.|It is the minimum trough concentration in plasma of glasdegib following multiple daily dosing to steady state.","5 years after last subject randomized, consent withdrawal, or death|2 years after last dose of study therapy|5 years after last patient randomized, withdrawal, or death|5 years after last subject randomized, withdrawal, or death|Day 10 of Induction Cycle and Day 1 of each Consolidation Cycle|Cycle 1 Day 15 and Cycles 2 and 3 on Day 1","ClinicalTrials.gov_Inquiries@pfizer.com","Pfizer CT.gov Call Center","1-800-718-1021","Adelaide, South|[Active, Not Recruiting]Darlinghurst, New South Wales, Australia, 2010 St George HospitalKogarah, New South Wales, Australia, 2217|Wels, Upper|[Active, Not Recruiting]Salzburg, Austria, 5020 Uniklinikum Salzburg, Landeskrankenhaus Salzburg[Active, Not Recruiting]Salzburg, Austria, 5020 Klinikum Wels-Grieskirchen GmbhWels, Austria, 4600 Sozialmedizinisches Zentrum Sud.[Active, Not Recruiting]Wien, Austria, 1100 Krankenhaus Hietzing Mit Neurologischem Zentrum Rosenhugel[Active, Not Recruiting]Wien, Austria, 1130|[Active, Not Recruiting]Brugge, Belgium, B-8000 Az Sint-Jan Brugge-Oostende Av[Active, Not Recruiting]Brugge, Belgium, B-8000 Universitaire Ziekenhuizen Brussel (Uz Brussel)Brussels, Belgium, B-1090 Universitaire Ziekenhuizen BrusselBrussels, Belgium, B-1090 Universitaire Ziekenhuizen Leuven[Active, Not Recruiting]Leuven, Belgium, B-3000|[Active, Not Recruiting]Winnipeg, Manitoba, Canada, R3A 1R9 Cancercare Manitoba[Active, Not Recruiting]Winnipeg, Manitoba, Canada, R3E 0V9|[Active, Not Recruiting]Toronto, Ontario, Canada, M4N 3M5 Princess Margaret Cancer Centre[Active, Not Recruiting]Toronto, Ontario, Canada, M5G 2M9|[Active, Not Recruiting]Montreal, Quebec, Canada, H1T 2M4|Saskatoon, Saskatchewan, Canada, S7N 0W8 Saskatoon Cancer CentreSaskatoon, Saskatchewan, Canada, S7N 4H4|Hefei, Anhui, China, 230001 Anhui Provincial HospitalHefei, Anhui, China, 230071|Fuzhou, Fujian, China, 350001|Guangzhou, Guangdong, China, 510080 Guangdong Second Provincial General HospitalGuangzhou, Guangdong, China, 510317|[Active, Not Recruiting]Langfang, Hebei, China, 065201|Zhengzhou, Henan, China, 450003 Henan Cancer HostipalZhengzhou, Henan, China, 450008|Chengdu, Sichuan, China, 610041|Wuhan, Hubei, China, 430030|Nanjing, Jiangsu, China, 210029|Beijing, China, 100044 Ruijin Hospital Affiliated To Shanghai Jiaotong University School Of MedicineShanghai, China, 200025|Shanghai, Shanghai, China, 200080|Xi'An, Shannxi, China, 710061|Tianjin, Tianjin, China, 300020|Hangzhou, Zhejiang, China, 310003|Brno, Czechia, 100 34 Nemocnicni LekarnaBrno, Czechia, 625 00 Ustavni LekarnaOstrava - Poruba, Czechia, 708 52 Klinika HematoonkologieOstrava-Poruba, Czechia, 708 52 InternÃ­ HematologickÃ¡ Klinika, Fakultni Nemocnice KrÃ¡lovskÃ© Vinohrady[Active, Not Recruiting]Praha 10, Czechia, 100 34 Ãšstavni LÃ©kÃ¡rna[Active, Not Recruiting]Praha 10, Czechia, 100 34|[Active, Not Recruiting]Creteil, France, 94010 Chu Henri Mondor[Active, Not Recruiting]CrÃ©teil, France, 94010 Chu De Nantes[Active, Not Recruiting]Nantes Cedex 1, France, 44093 Chu De Nantes Hotel Dieu[Active, Not Recruiting]Nantes Cedex, France, 44093 Hopital Saint LouisParis, France, 75010 Centre Hospitalier Lyon Sud - Service D'Hematologie[Active, Not Recruiting]Pierre Benite Cedex, France, 69495 Centre Hospitalier Lyon Sud -Unite De Pharmacie Clinique Oncologique[Active, Not Recruiting]Pierre Benite Cedex, France, 69495 Institut Gustave RoussyVillejuif Cedex, France, 94805|Augusta, Georgia, United States, 30912|[Active, Not Recruiting]Munich, Bavaria, Germany, 81377|[Active, Not Recruiting]Marburg, Hesse, Germany, 35032|[Active, Not Recruiting]Koeln, North Rhine Westphalia, Germany, 50937|Muenster, North Rhine-Westphalia, Germany, 48149|Muenster, North-Rhine-Westphalia, Germany, 48149|[Active, Not Recruiting]Hamburg, Germany, 20246 Medizinische Hochschule Hannover[Active, Not Recruiting]Hannover, Germany, 30625|Thessaloniki, Greece, 57010|[Active, Not Recruiting]Debrecen, Hungary, 4032 Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Klinika[Active, Not Recruiting]Debrecen, Hungary, 4032 Petz AladÃ¡r Megyei OktatÃ³ KÃ³rhÃ¡z, GyÃ³gyszerÃ©szeti OsztÃ¡lyGyÅ‘r, Hungary, 9024 Petz AladÃ¡r Megyei OktatÃ³ KÃ³rhÃ¡z, Ii. BelgyÃ³gyÃ¡szat- HematolÃ³giai OsztÃ¡lyGyÅ‘r, Hungary, 9024 Somogy Megyei Kaposi Mor Oktato KorhazKaposvar, Hungary, 7400 Szabolcs-Szatmar Bereg Megyei Korhazak Es Egyetemi Oktatokorhaz, Josa Andras Korhaz, HematologiaNyiregyhaza, Hungary, 4400 Szabolcs-Szatmar Bereg Megyei Korhazak Es Egyetemi Oktatokorhaz, Josa Andras Korhaz,Nyiregyhaza, Hungary, 4400|[Active, Not Recruiting]Haifa, Israel, 3109601 Shaare Zedek Medical Center[Active, Not Recruiting]Jerusalem, Israel, 9103102 Hadassah Medical Center (Ein Kerem)[Active, Not Recruiting]Jerusalem, Israel, 91120 Hemato-Oncology Ambulatory Service[Active, Not Recruiting]Petah Tikva, Israel, 4941492 Hematology Division - Oncology Pharmacy[Active, Not Recruiting]Petah Tikva, Israel, 4941492 Rabin Medical Center, Beilinson Hospital[Active, Not Recruiting]Petah Tikva, Israel, 4941492|[Active, Not Recruiting]Torette Di Ancona, An, Italy, 60126|[Active, Not Recruiting]Torrette Di Ancona, Ancona, Italy, 60126|[Active, Not Recruiting]Bologna, Italy, 40138 Azienda Ospedaliera Universitaria Senese[Active, Not Recruiting]Siena, Italy, 53100|Meldola, Fc, Italy, 47014|[Active, Not Recruiting]Cona, Ferrara, Fe, Italy, 44124 Farmacia Ospedaliera[Active, Not Recruiting]Ferrara, Fe, Italy, 44121|[Active, Not Recruiting]Pesaro, Pu, Italy, 61122|[Active, Not Recruiting]Siena, Si, Italy, 53100|[Active, Not Recruiting]Nagoya, Aichi, Japan, 466-8650|Akita, Japan, 010-8543 Kyushu University Hospital[Active, Not Recruiting]Fukuoka, Japan, 812-8582 National Hospital Organization Kumamoto Medical Center[Active, Not Recruiting]Kumamoto, Japan, 860-0008 Nagasaki University HospitalNagasaki, Japan, 852-8501 Tokyo Medical University Hospital[Active, Not Recruiting]Tokyo, Japan, 160-0023 Korea, Republic Of, Jeollabuk-Do Chonbuk National University Hospital[Active, Not Recruiting]Jeonju-Si, Jeollabuk-Do, Korea, Republic Of, 54907 Korea, Republic Of Department Of Pharmacy, Inje University Busan Paik Hospital[Active, Not Recruiting]Busan, Korea, Republic Of, 47392 Inje University Busan Paik Hospital[Active, Not Recruiting]Busan, Korea, Republic Of, 47392 Clinical Trial Pharmacy, Keimyung University Dongsan Hospital[Active, Not Recruiting]Daegu, Korea, Republic Of, 42601 Keimyung University Dongsan Hospital[Active, Not Recruiting]Daegu, Korea, Republic Of, 42601 Gachon University Gil Medical CenterIncheon, Korea, Republic Of, 21565 Seoul National University HospitalSeoul, Korea, Republic Of, 03080 Clinical Trial Center, Severance Hospital, Yonsei University Health System[Active, Not Recruiting]Seoul, Korea, Republic Of, 03722 Severance Hospital, Yonsei University Health System[Active, Not Recruiting]Seoul, Korea, Republic Of, 03722 Department Of Pharmacy, Samsung Medical Center[Active, Not Recruiting]Seoul, Korea, Republic Of, 06351 Samsung Medical Center[Active, Not Recruiting]Seoul, Korea, Republic Of, 06351 Department Of Pharmacy, Severance Hospital, Yonsei University Health System[Active, Not Recruiting]Seoul, Korea, Republic Of, 06591 The Catholic University Of Korea Seoul St. Mary'S Hospital[Active, Not Recruiting]Seoul, Korea, Republic Of, 06591 The Catholic University Of Korea, Seoul St. Mary'S Hospital[Active, Not Recruiting]Seoul, Korea, Republic Of, 06591|Yoshida-Gun, Fukui, Japan, 910-1193|[Active, Not Recruiting]Maebashi, Gunma, Japan, 371-8511|[Active, Not Recruiting]Kobe-Shi, Hyogo, Japan, 650-0017|[Active, Not Recruiting]Yokohama, Kanagawa, Japan, 232-0024|Sendai, Miyagi, Japan, 980-8574|[Active, Not Recruiting]Osaka-City, Osaka, Japan, 545-8586 Kindai University HospitalOsaka-Sayama, Osaka, Japan, 589-8511|[Active, Not Recruiting]Sunto-Gun, Shizuoka, Japan, 411-8777|Tachikawa, Tokyo, Japan, 190-0014|[Active, Not Recruiting]MÃ©xico, MÃ©x, Mexico, 14080|[Active, Not Recruiting]Monterrey, Nuevo Leon, Mexico, 64460|[Active, Not Recruiting]Gdansk, Poland, 80-214 Wwcoit Im. M. Kopernika W Lodzi[Active, Not Recruiting]Lodz, Poland, 93-513|Cluj-Napoca, Cluj, Romania, 400124|[Active, Not Recruiting]Craiova, Dolj, Romania, 200136|Bucuresti, Romania, 010825 Spitalul Clinic Coltea, Clinica De HematologieBucuresti, Romania, 030171 Russian Federation Sbhi Cch No. 40 Hd MoscowMoscow, Russian Federation, 129301 State Budgetary Healthcare Institution Of MoscowMoscow, Russian Federation, 129301 Sbhi Nnr Nn Rch N. A. N.A. SemashkoNizhniy Novgorod, Russian Federation, 603126 State Budgetary Institution Of Ryazan Region 'Regional Clinical Hospital' (Sbi Rr Rch)[Active, Not Recruiting]Ryazan, Russian Federation, 390039 Fsbi Russrhti Fmba Of|[Active, Not Recruiting]Barcelona, Spain, 08003 Hospital De La Santa Creu I Sant Pau[Active, Not Recruiting]Barcelona, Spain, 08025 Hospital Universitario Arnau De VilanovaLleida, Spain, 25198 Hospital General Universitario Gregorio MaranonMadrid, Spain, 28007 Hospital Universitario Ramon Y Cajal[Active, Not Recruiting]Madrid, Spain, 28034 Hospital Universitario Virgen Del RocioSevilla, Spain, 41013 Hospital Universitari I Politecnic La Fe[Active, Not Recruiting]Valencia, Spain, 46026|Orebro, Sweden, 701 85 Universitetssjukhuset OrebroOrebro, Sweden, 701 85 Apoex Ab Nks, Kliniska ProvningarSolna, Sweden, 171 64 Karolinska Universitetssjukhuset HuddingeStockholm, Sweden, 141 86 Taiwan National Cheng Kung University HospitalTainan, Taiwan, 704 National Taiwan University HospitalTaipei, Taiwan, 100 Department Of Clinical Trial Pharmacy, Taipei Veterans General HospitalTaipei, Taiwan, 11217 Taipei Veterans General HospitalTaipei, Taiwan, 11217 Division Of Pharmacy, Koo Foundation Sun Yat-Sen Cancer CenterTaipei, Taiwan, 112 Koo Foundation Sun Yat-Sen Cancer CenterTaipei, Taiwan, 112 Chang Gung Memorial Hospital-Linkou BranchTaoyuan City, Taiwan, 333 Chemotherapy Pharmacy, Chang Gung Memorial Hospital-Linkou BranchTaoyuan City, Taiwan, 333|Sutton, Surrey, United Kingdom, Sm2 5Pt|Birmingham, West Midlands, United Kingdom, B15 2Th University Hospitals Birmingham Nhs Foundation TrustBirmingham, West Midlands, United Kingdom, B30 3Hg|London, United Kingdom, W12 0Hs|Los Angeles, California, United States, 90095 Ucla Department Of MedicineLos Angeles, California, United States, 90095 Ucla Drug Information/Investigational DrugsLos Angeles, California, United States, 90095 Ucla Hematology/Oncology ClinicLos Angeles, California, United States, 90095 Ucla Ronald Reagan Medical CenterLos Angeles, California, United States, 90095 Uc Irvine Health - Chao Family Comprehensive Cancer CenterOrange, California, United States, 92868-3201 Uc Irvine Medical CenterOrange, California, United States, 92868-3201 Ucsf Helen Diller Family Comprehensive Cancer Center[Active, Not Recruiting]San Francisco, California, United States, 94143 University Of California, San Francisco Medical Center[Active, Not Recruiting]San Francisco, California, United States, 94143 University Of California, San Francisco[Active, Not Recruiting]San Francisco, California, United States, 94143 Ucla Hematology/Oncology - Westlake VillageWestlake Village, California, United States, 91361|Augusta, Georgia, United States, 30912 Augusta University Medical CenterAugusta, Georgia, United States, 30912|[Active, Not Recruiting]Boston, Massachusetts, United States, 02111 Tufts Medical Center[Active, Not Recruiting]Boston, Massachusetts, United States, 02111 Massachusetts General Hospital[Active, Not Recruiting]Boston, Massachusetts, United States, 02114|Kansas City, Missouri, United States, 64132|[Active, Not Recruiting]Lake Success, New York, United States, 11042 North Shore University Hospital[Active, Not Recruiting]Manhasset, New York, United States, 11030 Long Island Jewish Medical Center[Active, Not Recruiting]New Hyde Park, New York, United States, 11040 University Of Rochester Cancer Center Pharmacy[Active, Not Recruiting]Rochester, New York, United States, 14642 University Of Rochester Medical Center[Active, Not Recruiting]Rochester, New York, United States, 14642|[Active, Not Recruiting]Cleveland, Ohio, United States, 44106 University Hospitals Cleveland Medical CenterCleveland, Ohio, United States, 44106 Cleveland Clinic Foundation[Active, Not Recruiting]Cleveland, Ohio, United States, 44195|Portland, Oregon, United States, 97239 Oregon Health & Science University-Research Pharmacy ServicesPortland, Oregon, United States, 97239 Oregon Health & Science UniversityPortland, Oregon, United States, 97239|[Active, Not Recruiting]Nashville, Tennessee, United States, 37203 The Sarah Cannon Research Institute[Active, Not Recruiting]Nashville, Tennessee, United States, 37203 Tristar Bone Marrow Transplant[Active, Not Recruiting]Nashville, Tennessee, United States, 37203|Dallas, Texas, United States, 75246 Baylor University Medical CenterDallas, Texas, United States, 75246 Blood Cancer And Stem Cell Transplant ClinicSan Antonio, Texas, United States, 78229 Methodist Healthcare System Of San AntonioSan Antonio, Texas, United States, 78229 Methodist Hospital Investigational PharmacySan Antonio, Texas, United States, 78229|Seattle, Washington, United States, 98104 Swedish First Hill Ids PharmacySeattle, Washington, United States, 98104 Swedish Medical CenterSeattle, Washington, United States, 98122","California|Georgia|Massachusetts|Missouri|New York|Ohio|Oregon|Tennessee|Texas|Washington","Australia|Austria|Belgium|Canada|China|Czechia|France|Georgia|Germany|Greece|Hungary|Israel|Italy|Japan|Mexico|Poland|Romania|Spain|Sweden|United Kingdom|United States","Australia, 5000 Royal Adelaide Hospital|New South Wales St Vincent's Hospital Sydney|Royal Adelaide Hospital - Clinical Trials Pharmacy|Klinikum Wels-Grieskirchen Gmbh|Landeskrankenhaus Salzburg, Universitatsklinik Fur Innere Medizin Iii Der Pmu|Az Sint-Jan Brugge - Oostende Av|Manitoba Health Sciences Centre|Ontario Sunnybrook Research Institute|Quebec Ciusss De L'Est-De-L'Ile-De- MontrÃ©al - HÃ´pital Maisonneuve-Rosemont|Saskatchewan Royal University Hospital|Anhui The First Affiliated Hospital Of Ustc, Anhui Province Hospital|Fujian Fujian Medical University Union Hospital|Guangdong Guangdong Provincial People's Hospital|Hebei Hebei Yanda Lu Daopei Hospital|Henan Henan Provincial People's Hospital/Hematology Department|Hospital, Sichuan University|Hubei Tongji Hospital, Tongji Medical College, Huazhong University Of Science & Technology/Cancer Center|Jiangsu Jiangsu Province Hospital|Peking University People's Hospital|Shanghai Shanghai General Hospital|Shannxi The First Affiliated Hospital Of Xi'An Jiaotong University|Tianjin Institute Of Hematology And Blood Diseases Hospital, Chinese Academy Of Medical Sciences|Zhejiang The First Affiliated Hospital College Of Medicine, Zhejiang University|Interni Hematologicka A Onkologicka Klinika, Fakultni Nemocnice Brno|Chu Henri Mondor|Cancer Center At Augusta University|Bavaria Klinikum Der Universitaet Muenchen|Hesse Philipps-Universitaet Marburg|North Rhine Westphalia UniversitÃ¤tsklinikum KÃ¶ln|North Rhine-Westphalia Universitaetsklinikum Muenster|North-Rhine-Westphalia Universitaetsklinikum Muenster|Universitaetsklinikum Hamburg-Eppendorf|General Hospital Of Thessaloniki|Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Klinika, Hematologia Tanszek|Rambam Health Care Campus|An Sod Farmacia-Dipt Dei Servizi -Aou Ospedali Riuniti Umberto I, G.M. Lancisi, G. Salesi|Ancona Aou Ospedali Riuniti Umberto I, G.M. Lancisi, G. Salesi, Clinica Di Ematologia|Azienda Ospedaliero Universitaria Di Bologna Policlinico S.Orsola Malpighi|Fc Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori|Fe A.O.U. Di Ferrara- Arcispedale Sant'Anna,|Pu Ao Ospedali Riuniti Marche Nord - Presidio Ospedaliero San Salvatore Di Pesaro -|Si Azienda Ospedaliera Universitaria Senese.|Aichi Japanese Red Cross Nagoya Daini Hospital|Akita University Hospital|Fukui University Of Fukui Hospital|Gunma Gunma University Hospital|Hyogo Kobe University Hospital|Kanagawa Yokohama City University Medical Center|Miyagi Tohoku University Hospital|Osaka Osaka City University Hospital|Shizuoka Shizuoka Cancer Center|Tokyo National Hospital Organization Disaster Medical Center|MÃ©x Instituto Nacional De CancerologÃ­a|Nuevo Leon Hospital Unversitario \"Dr. Jose Eleuterio Gonzalez\"|Klinika Hematologii I Transplantologii Uniwersyteckie Centrum Kliniczne|Cluj Institutul Oncologic 'Prof. Dr. Ion Chiricuta'|Dolj Spitalul Clinic Municipal Filantropia Craiova, Sectia Clinica Hematologie|Spitalul Universitar De Urgenta Militar Central \"Dr. Carol Davila\" Bucuresti|Hospital Del Mar|Apoex Vn|, Surrey The Royal Marsden Nhs Foundation Trust|, West Midlands University Hospitals Birmingham Nhs Foundation Trust|Imperial College Healthcare Nhs Trust|Rrmc - Ucla|Augusta University Medical Center Clinical Research Pharmacy|Tufts Medical Center Investigational Pharmacy|Midamerica Division, Inc., C/O Research Medical Center|Northwell Health/Monter Cancer Center|Taussig Cancer Center Investigational Pharmacy|Ohsu Center For Health And Healing|Centennial Medical Center|Baylor Scott And White Research Institute|Swedish Cancer Institute",{"$nulls":3},"Pfizer CT.gov Call Center","2020-04-07","2020-05-25T16:39:41.485","2020-05-26T17:10:42.972","NCT03416179"]
["5ecbf4cd307e3d1b1f8d9e58","NCT03416179","2020-04-28","Pfizer","PFE","Recruiting","A Study Evaluating Intensive Chemotherapy With or Without Glasdegib or Azacitidine With or Without Glasdegib In Patients With Previously Untreated Acute Myeloid Leukemia (BRIGHT AML1019)","Glasdegib|Cytarabine|Daunorubicin|Azacitidine","Hh Inhibitor|DNA Polymerase Inhibitor|Nucleic Acid Synthesis Inhibitor|TOP2 Inhibitor|DNA Mtase Inhibitor","Unknown",null,"Unknown",null,"Phase 3",4,720,"Anticipated","2018-04-20","2020-12-14","OS","Overall Survival",{"$nulls":3},"Glasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).\n\nGlasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).","Two separate registration trials conducted under one protocol number are proposed to adequately and independently evaluate the addition of glasdegib in intensive and non-intensive chemotherapy populations. Each study will have an experimental treatment arm and a placebo arm. Endpoints are the same for each study except where specifically indicated.\n\nAssignment to the Intensive Study or the Non-Intensive Study will be made by the Investigator based on the 2017 European LeukemiaNet (ELN) recommendations.\n\nStudy B1371019 is a randomized (1:1), double-blind, multi-center, placebo controlled study of chemotherapy in combination with glasdegib versus chemotherapy in combination with placebo in adult patients with previously untreated AML.\n\nGlasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population).\n\nGlasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).","A RANDOMIZED (1:1), DOUBLE-BLIND, MULTI-CENTER, PLACEBO CONTROLLED STUDY EVALUATING INTENSIVE CHEMOTHERAPY WITH OR WITHOUT GLASDEGIB (PF-04449913) OR AZACITIDINE (AZA) WITH OR WITHOUT GLASDEGIB IN PATIENTS WITH PREVIOUSLY UNTREATED ACUTE MYELOID LEUKEMIA","B1371019","Leukemia, Myeloid, Acute","Acute Leukemia|Acute Myeloid Leukemia|Myeloid Leukemia|Leukemia","Oncology Hematological","Oncology","Experimental|Placebo Comparator","Arm A (Intensive Study)|Arm B (Intensive Study)|Arm A (Non-intensive study)|Arm B (Non-intensive study)","Glasdegib + '7+3' Induction(s)|Placebo + '7+3' Induction(s)|Glasdegib + azacitidine|Placebo + azacitidine","Drug|Procedure","glasdegib|daunorubicin + cytarabine|cytarabine|HSCT|Placebo|azacitidine","Daily Glasdegib (100 mg, PO), beginning on Day 1 and is to continue up to 2 years post randomization.\n\nFollowing consolidation therapy, glasdegib or placebo will be administered daily for up to 2 years after randomization or until they have minimal residual disease (MRD) negative disease, whichever comes first.\n\nDaily Glasdegib (100 mg, PO) or matching placebo will continue throughout Induction(s) and Consolidation therapies regardless of dose modifications/delays in the chemotherapy.|Consolidation with single agent cytarabine 3 g/m2 IV for adults <60 years and 1 g/m2 for adults 60 years over 3 BID on Days 1, 3, and 5, every 28 days for up to 4 cycles or alternative single agent cytarabine consolidation schedules may be used per local prescribing information.|If required, and done per standard of care post Induction(s).|Azacitidine (75 mg/m2, SC or IV) daily for 7 days, in 28 day cycles for as long as they do not meet the criteria for disease progression, unacceptable toxicity, consent withdrawal, or death.|Matching placebo (PO) is to be administered by mouth daily beginning on Day 1 of chemotherapy and will continue if subjects demonstrate reasonable evidence of clinical benefit and do not meet the criteria for progression regardless of any delays/modifications in the chemotherapy treatment. Subjects will continue placebo until disease progression, unacceptable toxicity, consent withdrawal, or death, whichever comes first.","PF-04449913","Arm A (Intensive Study)|Arm B (Intensive Study)|Arm A (Non-intensive study)|Arm B (Non-intensive study)","\n\nSubjects must meet all of the following inclusion criteria to be eligible for enrollment into the Intensive and Non Intensive study (unless where indicated):\n\n 1.  Subjects with untreated AML according to the World Health Organization (WHO) 2016 Classification2, including those with: * AML arising from MDS or another antecedent hematologic disease (AHD).\n      * AML after previous cytotoxic therapy or radiation (secondary AML).\n     \n     \n 2.  18 years of age (In Japan, 20 years of age).\n 3.  Adequate Organ Function as defined by the following: * Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) 3 x upper limit of normal (ULN), excluding subjects with liver function abnormalities due to underlying malignancy.\n      * Total serum bilirubin 2 x ULN (except subjects with documented Gilbert's syndrome).\n      * Estimated creatinine clearance 30 mL/min as calculated using the standard method for the institution.\n     \n     \n 4.  QTc interval 470 msec using the Fridericia correction (QTcF).\n 5.  All anti cancer treatments (unless specified) should be discontinued 2 weeks from study entry, for example: targeted chemotherapy, radiotherapy, investigational agents, hormones, anagrelide or cytokines. * For control of rapidly progressing leukemia, all trans retinoic acid (ATRA), hydroxyurea, and/or leukopheresis may be used before and for up to 1 week after the first dose of glasdegib.\n     \n     \n 6.  Serum or urine pregnancy test (for female subjects of childbearing potential) with a minimum sensitivity of 25 IU/L or equivalent units of human chorionic gonadotropin (hCG) negative at screening.\n 7.  Male and female subjects of childbearing potential and at risk for pregnancy must agree to use at least one highly effective method of contraception throughout the study and for 180 days after the last dose of azacitidine, cytarabine, or daunorubicin; and the last dose of glasdegib or placebo, whichever occurs later.\n 8.  Female subjects of non childbearing potential must meet at least 1 of the following criteria: 1. Have undergone a documented hysterectomy and/or bilateral oophorectomy;\n      2. Have medically confirmed ovarian failure; or\n      3. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; status may be confirmed by having a serum follicle stimulating hormone (FSH) level confirming the postmenopausal state.\n     \n     All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential.\n     \n     \n 9.  Consent to a saliva sample collection for a germline comparator, unless prohibited by local regulations or ethics committee (EC) decision.\n 10. Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.\n 11. Subjects who are willing and able to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures (including bone marrow [BM] assessments).\n\n","\n\nSubjects with any of the following characteristics/conditions will not be included in the study:\n\n 1.  Acute Promyelocytic Leukemia (APL) and APLwith PML RARA, subjects (WHO 2016 classification).\n 2.  AML with BCR ABL1 or t(9;22)(q34;q11.2) as a sole abnormality. * Complex genetics may include t(9;22) cytogenetic translocation.\n     \n     \n 3.  Subjects with known active CNS leukemia.\n 4.  Participation in other clinical studies involving other investigational drug(s) (Phases 1 4) within 4 weeks prior study entry and/or during study participation.\n 5.  Subjects known to be refractory to platelet or packed red cell transfusions per Institutional Guidelines, or a patient who refuses blood product support.\n 6.  Subjects with another active malignancy on treatment with the exception of basal cell carcinoma, non melanoma skin cancer, cervical carcinoma in situ. Other prior or concurrent malignancies will be considered on a case by case basis.\n 7.  Any one of the following ongoing or in the previous 6 months: myocardial infarction, congenital long QT syndrome, Torsades de pointes, symptomatic arrhythmias (including sustained ventricular tachyarrhythmia), right or left bundle branch block and bifascicular block, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (CHF New York Heart Association class III or IV), cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism; as well as bradycardia defined as <50 bpms.\n 8.  Subjects with an active, life threatening or clinically significant uncontrolled systemic infection not related to AML.\n 9.  Subjects with left ventricular ejection fraction (LVEF) <50% are excluded from the Intensive Chemotherapy Study only.\n 10. Cumulative anthracycline dose equivalent of 550 mg/m2 of daunorubicin for the Intensive Chemotherapy Study only.\n 11. Known malabsorption syndrome or other condition that may significantly impair absorption of study medication in the investigator's judgment (eg, gastrectomy, lap band, Crohn's disease) and inability or unwillingness to swallow tablets or capsules.\n 12. Current use or anticipated requirement for drugs that are known strong CYP3A4/5 inducers.\n 13. Concurrent administration of herbal preparations.\n 14. Major surgery or radiation within 4 weeks of starting study treatment.\n 15. Documented or suspected hypersensitivity to any one of the following: * For subjects assigned to intensive chemotherapy, documented or suspected hypersensitivity to cytarabine (not including drug fever or exanthema, including known cerebellar side effects) or daunorubicin.\n      * For subjects assigned to non intensive chemotherapy, documented or suspected hypersensitivity to azacitidine or mannitol.\n     \n     \n 16. Known active drug or alcohol abuse.\n 17. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.\n 18. Pregnant females or breastfeeding female subjects.\n 19. Known recent or active suicidal ideation or behavior.\n 20. Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.","FSH",null,"Protein","Ovary","Actual","2018-01-31","Actual","Anticipated","2025-02-12","Anticipated","2020-04-01","2017-12-21","2018-01-23","2020-04-24","Yes","glasdegib;\nuntreated;\nHedgehog Inhibitor","Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","18 Years",null,"All",null,"No","Yes\nPfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.",null,"URL: https://pmiform.com/clinical-trial-info-request?StudyID=B1371019 [https://pmiform.com/clinical-trial-info-request?StudyID=B1371019] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To obtain contact information for a study center near you, click here.",null,"Yes","No",{"$nulls":17},"2017-002822-19|BRIGHT|BRIGHT AML1019","EudraCT Number|Alias Study Number","Overall survival","5 years after last subject randomized",null,"Fatigue score measured by the MD Anderson Symptom Inventory (MDASI)-AML/MDS questionnaire|Rate of Complete Remission (CR) (including CR with minimal residual disease (MRD)-negative as assessed by multiparametric flow cytometry)|Duration of response (defined as CR [includes CR-MRD negative]/CRi or CR/CRh as appropriate)|Time to response (CR[includes CR-MRD negative)]/CR with partial hematologic rcovery (CRh) as appropriate)|Event-free Survival|Patient Reported Outcomes (PROs) as measured by the M.D. Anderson Symptom Inventory AML/MDS Module (MDASI-AML/MDS)|Adverse events as graded by NCI CTCAE v4.03|Laboratory abnormalities as graded by NCI CTCAE v4.03|For the intensive study, the plasma trough concentration (Ctrough) will be analyzed|QTc interval|PROs as measured by Patient Global Impression of Change (PGIC)|Patient Reported Outcomes (PROs) as measured by EuroQoL 5 Dimension questionnaire 5-Level version (EQ-5D-5L)|Patient Reported Outcomes (PROs) as measured by Patient Global Impression of Symptoms (PGIS)|Complete Remission with incomplete hematologic recovery (CRi)|Rate of morphological leukemia-free state (MLFS)|Rate of Partial Remission (PR)|Rate of Complete Remission with partial hematological recovery (CRh) for the Non-intensive study only only|Minimum Observed Plasma Trough Concentratrion of glasdegib in the Intensive Study|Minimum Observed Plasma Trough Concentration of glasdegib in the Non-intensive study","Scale is from 0-10 where 0 is not present and 10 is as bad as you can image.|Response as defined by the 2017 European LeukemiaNet (ELN) recommendations.|5 years after last subject randomized, consent withdrawal, or death|Measurement Scale from 0-10.|PK samples taken on Induction(s) Day 1 (1 and 4 hours post induction); Induction(s) Day 10 (pre-dose, 1 and 4 hours post dose); Day 1 of each Consolidation cycle (pre-dose, 1 and 4 hours post dose)|One question asking for description of leukemia symptoms.|Series of questions that ask for information that best describes health.|One question asking for information regarding leukemia symptoms.|Its the minimum trough concentration in plasma of glasdegib following multiple daily dosing to steady state.|It is the minimum trough concentration in plasma of glasdegib following multiple daily dosing to steady state.","5 years after last subject randomized, consent withdrawal, or death|2 years after last dose of study therapy|5 years after last patient randomized, withdrawal, or death|5 years after last subject randomized, withdrawal, or death|Day 10 of Induction Cycle and Day 1 of each Consolidation Cycle|Cycle 1 Day 15 and Cycles 2 and 3 on Day 1","ClinicalTrials.gov_Inquiries@pfizer.com","Pfizer CT.gov Call Center","1-800-718-1021","[Active, Not Recruiting]Adelaide, South|[Active, Not Recruiting]Darlinghurst, New South Wales, Australia, 2010 St George Hospital[Active, Not Recruiting]Kogarah, New South Wales, Australia, 2217|[Active, Not Recruiting]Salzburg, Austria, 5020 Uniklinikum Salzburg, Landeskrankenhaus Salzburg[Active, Not Recruiting]Salzburg, Austria, 5020 Sozialmedizinisches Zentrum Sud.[Active, Not Recruiting]Wien, Austria, 1100 Krankenhaus Hietzing Mit Neurologischem Zentrum Rosenhugel[Active, Not Recruiting]Wien, Austria, 1130|[Active, Not Recruiting]Brugge, Belgium, B-8000 Universitaire Ziekenhuizen Brussel (Uz Brussel)[Active, Not Recruiting]Brussels, Belgium, B-1090 Universitaire Ziekenhuizen Brussel[Active, Not Recruiting]Brussels, Belgium, B-1090 Universitaire Ziekenhuizen Leuven[Active, Not Recruiting]Leuven, Belgium, B-3000|[Active, Not Recruiting]Winnipeg, Manitoba, Canada, R3A 1R9 Cancercare Manitoba[Active, Not Recruiting]Winnipeg, Manitoba, Canada, R3E 0V9|[Active, Not Recruiting]Toronto, Ontario, Canada, M4N 3M5 Princess Margaret Cancer Centre[Active, Not Recruiting]Toronto, Ontario, Canada, M5G 2M9|[Active, Not Recruiting]Montreal, Quebec, Canada, H1T 2M4|[Active, Not Recruiting]Saskatoon, Saskatchewan, Canada, S7N 0W8 Saskatoon Cancer Centre[Active, Not Recruiting]Saskatoon, Saskatchewan, Canada, S7N 4H4|Hefei, Anhui, China, 230001 Anhui Provincial HospitalHefei, Anhui, China, 230071|Fuzhou, Fujian, China, 350001|Guangzhou, Guangdong, China, 510080 Guangdong Second Provincial General HospitalGuangzhou, Guangdong, China, 510317|[Active, Not Recruiting]Langfang, Hebei, China, 065201|Zhengzhou, Henan, China, 450003 Henan Cancer HostipalZhengzhou, Henan, China, 450008|Chengdu, Sichuan, China, 610041|Wuhan, Hubei, China, 430030|Shanghai, China, 200025|Tianjin, Tianjin, China, 300020|Hangzhou, Zhejiang, China, 310003|[Active, Not Recruiting]Brno, Czechia, 100 34 Nemocnicni Lekarna[Active, Not Recruiting]Brno, Czechia, 625 00 Ustavni Lekarna[Active, Not Recruiting]Ostrava - Poruba, Czechia, 708 52 Klinika Hematoonkologie[Active, Not Recruiting]Ostrava-Poruba, Czechia, 708 52 InternÃ­ HematologickÃ¡ Klinika, Fakultni Nemocnice KrÃ¡lovskÃ© Vinohrady[Active, Not Recruiting]Praha 10, Czechia, 100 34 Ãšstavni LÃ©kÃ¡rna[Active, Not Recruiting]Praha 10, Czechia, 100 34|[Active, Not Recruiting]Creteil, France, 94010 Chu Henri Mondor[Active, Not Recruiting]CrÃ©teil, France, 94010 Chu De Nantes[Active, Not Recruiting]Nantes Cedex 1, France, 44093 Chu De Nantes Hotel Dieu[Active, Not Recruiting]Nantes Cedex, France, 44093 Hopital Saint Louis[Active, Not Recruiting]Paris, France, 75010 Centre Hospitalier Lyon Sud - Service D'Hematologie[Active, Not Recruiting]Pierre Benite Cedex, France, 69495 Centre Hospitalier Lyon Sud -Unite De Pharmacie Clinique Oncologique[Active, Not Recruiting]Pierre Benite Cedex, France, 69495 Institut Gustave Roussy[Active, Not Recruiting]Villejuif Cedex, France, 94805|[Active, Not Recruiting]Augusta, Georgia, United States, 30912|[Active, Not Recruiting]Munich, Bavaria, Germany, 81377|[Active, Not Recruiting]Marburg, Hesse, Germany, 35032|[Active, Not Recruiting]Koeln, North Rhine Westphalia, Germany, 50937|[Active, Not Recruiting]Muenster, North Rhine-Westphalia, Germany, 48149|[Active, Not Recruiting]Muenster, North-Rhine-Westphalia, Germany, 48149|[Active, Not Recruiting]Hamburg, Germany, 20246 Medizinische Hochschule Hannover[Active, Not Recruiting]Hannover, Germany, 30625|[Active, Not Recruiting]Debrecen, Hungary, 4032 Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Klinika[Active, Not Recruiting]Debrecen, Hungary, 4032 Petz AladÃ¡r Megyei OktatÃ³ KÃ³rhÃ¡z, GyÃ³gyszerÃ©szeti OsztÃ¡ly[Active, Not Recruiting]GyÅ‘r, Hungary, 9024 Petz AladÃ¡r Megyei OktatÃ³ KÃ³rhÃ¡z, Ii. BelgyÃ³gyÃ¡szat- HematolÃ³giai OsztÃ¡ly[Active, Not Recruiting]GyÅ‘r, Hungary, 9024 Somogy Megyei Kaposi Mor Oktato Korhaz[Active, Not Recruiting]Kaposvar, Hungary, 7400 Szabolcs-Szatmar Bereg Megyei Korhazak Es Egyetemi Oktatokorhaz, Josa Andras Korhaz, HematologiaNyiregyhaza, Hungary, 4400 Szabolcs-Szatmar Bereg Megyei Korhazak Es Egyetemi Oktatokorhaz, Josa Andras Korhaz,Nyiregyhaza, Hungary, 4400|[Active, Not Recruiting]Haifa, Israel, 3109601 Shaare Zedek Medical Center[Active, Not Recruiting]Jerusalem, Israel, 9103102 Hadassah Medical Center (Ein Kerem)[Active, Not Recruiting]Jerusalem, Israel, 91120 Hemato-Oncology Ambulatory Service[Active, Not Recruiting]Petah Tikva, Israel, 4941492 Rabin Medical Center, Beilinson Hospital[Active, Not Recruiting]Petah Tikva, Israel, 4941492|[Active, Not Recruiting]Torette Di Ancona, An, Italy, 60126|[Active, Not Recruiting]Torrette Di Ancona, Ancona, Italy, 60126|[Active, Not Recruiting]Bologna, Italy, 40138 Azienda Ospedaliera Universitaria Senese[Active, Not Recruiting]Siena, Italy, 53100|[Active, Not Recruiting]Cona, Ferrara, Fe, Italy, 44124 Farmacia Ospedaliera[Active, Not Recruiting]Ferrara, Fe, Italy, 44121|[Active, Not Recruiting]Pesaro, Pu, Italy, 61122|[Active, Not Recruiting]Siena, Si, Italy, 53100|[Active, Not Recruiting]Nagoya, Aichi, Japan, 466-8650|[Active, Not Recruiting]Akita, Japan, 010-8543 Kyushu University Hospital[Active, Not Recruiting]Fukuoka, Japan, 812-8582 National Hospital Organization Kumamoto Medical Center[Active, Not Recruiting]Kumamoto, Japan, 860-0008 Nagasaki University Hospital[Active, Not Recruiting]Nagasaki, Japan, 852-8501 Tokyo Medical University Hospital[Active, Not Recruiting]Tokyo, Japan, 160-0023 Korea, Republic Of, Jeollabuk-Do Chonbuk National University Hospital[Active, Not Recruiting]Jeonju-Si, Jeollabuk-Do, Korea, Republic Of, 54907 Korea, Republic Of Department Of Pharmacy, Inje University Busan Paik Hospital[Active, Not Recruiting]Busan, Korea, Republic Of, 47392 Inje University Busan Paik Hospital[Active, Not Recruiting]Busan, Korea, Republic Of, 47392 Clinical Trial Pharmacy, Keimyung University Dongsan Hospital[Active, Not Recruiting]Daegu, Korea, Republic Of, 42601 Keimyung University Dongsan Hospital[Active, Not Recruiting]Daegu, Korea, Republic Of, 42601 Gachon University Gil Medical Center[Active, Not Recruiting]Incheon, Korea, Republic Of, 21565 Seoul National University Hospital[Active, Not Recruiting]Seoul, Korea, Republic Of, 03080 Clinical Trial Center, Severance Hospital, Yonsei University Health System[Active, Not Recruiting]Seoul, Korea, Republic Of, 03722 Severance Hospital, Yonsei University Health System[Active, Not Recruiting]Seoul, Korea, Republic Of, 03722 Department Of Pharmacy, Samsung Medical Center[Active, Not Recruiting]Seoul, Korea, Republic Of, 06351 Samsung Medical Center[Active, Not Recruiting]Seoul, Korea, Republic Of, 06351 Department Of Pharmacy, Severance Hospital, Yonsei University Health System[Active, Not Recruiting]Seoul, Korea, Republic Of, 06591 The Catholic University Of Korea Seoul St. Mary'S Hospital[Active, Not Recruiting]Seoul, Korea, Republic Of, 06591 The Catholic University Of Korea, Seoul St. Mary'S Hospital[Active, Not Recruiting]Seoul, Korea, Republic Of, 06591|[Active, Not Recruiting]Yoshida-Gun, Fukui, Japan, 910-1193|[Active, Not Recruiting]Maebashi, Gunma, Japan, 371-8511|[Active, Not Recruiting]Kobe-Shi, Hyogo, Japan, 650-0017|[Active, Not Recruiting]Yokohama, Kanagawa, Japan, 232-0024|[Active, Not Recruiting]Sendai, Miyagi, Japan, 980-8574|[Active, Not Recruiting]Osaka-City, Osaka, Japan, 545-8586 Kindai University Hospital[Active, Not Recruiting]Osaka-Sayama, Osaka, Japan, 589-8511|[Active, Not Recruiting]Sunto-Gun, Shizuoka, Japan, 411-8777|[Active, Not Recruiting]Tachikawa, Tokyo, Japan, 190-0014|[Active, Not Recruiting]MÃ©xico, MÃ©x, Mexico, 14080|[Active, Not Recruiting]Monterrey, Nuevo Leon, Mexico, 64460|[Active, Not Recruiting]Gdansk, Poland, 80-214 Wwcoit Im. M. Kopernika W Lodzi[Active, Not Recruiting]Lodz, Poland, 93-513|[Active, Not Recruiting]Cluj-Napoca, Cluj, Romania, 400124|[Active, Not Recruiting]Craiova, Dolj, Romania, 200136|[Active, Not Recruiting]Bucuresti, Romania, 010825 Spitalul Clinic Coltea, Clinica De Hematologie[Active, Not Recruiting]Bucuresti, Romania, 030171 Russian Federation Sbhi Cch No. 40 Hd Moscow[Active, Not Recruiting]Moscow, Russian Federation, 129301 State Budgetary Healthcare Institution Of Moscow[Active, Not Recruiting]Moscow, Russian Federation, 129301 Sbhi Nnr Nn Rch N. A. N.A. Semashko[Active, Not Recruiting]Nizhniy Novgorod, Russian Federation, 603126 State Budgetary Institution Of Ryazan Region 'Regional Clinical Hospital' (Sbi Rr Rch)[Active, Not Recruiting]Ryazan, Russian Federation, 390039 Fsbi Russrhti Fmba Of|[Active, Not Recruiting]Barcelona, Spain, 08003 Hospital De La Santa Creu I Sant Pau[Active, Not Recruiting]Barcelona, Spain, 08025 Hospital Universitario Arnau De Vilanova[Active, Not Recruiting]Lleida, Spain, 25198 Hospital General Universitario Gregorio Maranon[Active, Not Recruiting]Madrid, Spain, 28007 Hospital Universitario Ramon Y Cajal[Active, Not Recruiting]Madrid, Spain, 28034 Hospital Universitario Virgen Del Rocio[Active, Not Recruiting]Sevilla, Spain, 41013 Hospital Universitari I Politecnic La Fe[Active, Not Recruiting]Valencia, Spain, 46026|[Active, Not Recruiting]Orebro, Sweden, 701 85 Universitetssjukhuset Orebro[Active, Not Recruiting]Orebro, Sweden, 701 85 Apoex Ab Nks, Kliniska Provningar[Active, Not Recruiting]Solna, Sweden, 171 64 Karolinska Universitetssjukhuset Huddinge[Active, Not Recruiting]Stockholm, Sweden, 141 86 Taiwan National Cheng Kung University Hospital[Active, Not Recruiting]Tainan, Taiwan, 704 National Taiwan University Hospital[Active, Not Recruiting]Taipei, Taiwan, 100 Department Of Clinical Trial Pharmacy, Taipei Veterans General Hospital[Active, Not Recruiting]Taipei, Taiwan, 11217 Taipei Veterans General Hospital[Active, Not Recruiting]Taipei, Taiwan, 11217 Division Of Pharmacy, Koo Foundation Sun Yat-Sen Cancer Center[Active, Not Recruiting]Taipei, Taiwan, 112 Koo Foundation Sun Yat-Sen Cancer Center[Active, Not Recruiting]Taipei, Taiwan, 112 Chang Gung Memorial Hospital-Linkou Branch[Active, Not Recruiting]Taoyuan City, Taiwan, 333 Chemotherapy Pharmacy, Chang Gung Memorial Hospital-Linkou Branch[Active, Not Recruiting]Taoyuan City, Taiwan, 333|[Active, Not Recruiting]Sutton, Surrey, United Kingdom, Sm2 5Pt|[Active, Not Recruiting]Birmingham, West Midlands, United Kingdom, B15 2Th University Hospitals Birmingham Nhs Foundation Trust[Active, Not Recruiting]Birmingham, West Midlands, United Kingdom, B30 3Hg|[Active, Not Recruiting]London, United Kingdom, W12 0Hs|[Active, Not Recruiting]Los Angeles, California, United States, 90095 Ucla Department Of Medicine[Active, Not Recruiting]Los Angeles, California, United States, 90095 Ucla Drug Information/Investigational Drugs[Active, Not Recruiting]Los Angeles, California, United States, 90095 Ucla Hematology/Oncology Clinic[Active, Not Recruiting]Los Angeles, California, United States, 90095 Ucla Ronald Reagan Medical Center[Active, Not Recruiting]Los Angeles, California, United States, 90095 Uc Irvine Health - Chao Family Comprehensive Cancer Center[Active, Not Recruiting]Orange, California, United States, 92868-3201 Uc Irvine Medical Center[Active, Not Recruiting]Orange, California, United States, 92868-3201 Ucsf Helen Diller Family Comprehensive Cancer Center[Active, Not Recruiting]San Francisco, California, United States, 94143 University Of California, San Francisco Medical Center[Active, Not Recruiting]San Francisco, California, United States, 94143 University Of California, San Francisco[Active, Not Recruiting]San Francisco, California, United States, 94143 Ucla Hematology/Oncology - Westlake Village[Active, Not Recruiting]Westlake Village, California, United States, 91361|[Active, Not Recruiting]Augusta, Georgia, United States, 30912 Augusta University Medical Center[Active, Not Recruiting]Augusta, Georgia, United States, 30912|[Active, Not Recruiting]Boston, Massachusetts, United States, 02111 Tufts Medical Center[Active, Not Recruiting]Boston, Massachusetts, United States, 02111 Massachusetts General Hospital[Active, Not Recruiting]Boston, Massachusetts, United States, 02114|[Active, Not Recruiting]Kansas City, Missouri, United States, 64132|[Active, Not Recruiting]Lake Success, New York, United States, 11042 North Shore University Hospital[Active, Not Recruiting]Manhasset, New York, United States, 11030 Long Island Jewish Medical Center[Active, Not Recruiting]New Hyde Park, New York, United States, 11040 University Of Rochester Cancer Center Pharmacy[Active, Not Recruiting]Rochester, New York, United States, 14642 University Of Rochester Medical Center[Active, Not Recruiting]Rochester, New York, United States, 14642|[Active, Not Recruiting]Cleveland, Ohio, United States, 44106 University Hospitals Cleveland Medical Center[Active, Not Recruiting]Cleveland, Ohio, United States, 44106 Cleveland Clinic Foundation[Active, Not Recruiting]Cleveland, Ohio, United States, 44195|[Active, Not Recruiting]Portland, Oregon, United States, 97239 Oregon Health & Science University-Research Pharmacy Services[Active, Not Recruiting]Portland, Oregon, United States, 97239 Oregon Health & Science University[Active, Not Recruiting]Portland, Oregon, United States, 97239|[Active, Not Recruiting]Nashville, Tennessee, United States, 37203 Tristar Bone Marrow Transplant[Active, Not Recruiting]Nashville, Tennessee, United States, 37203|[Active, Not Recruiting]Dallas, Texas, United States, 75246 Baylor University Medical Center[Active, Not Recruiting]Dallas, Texas, United States, 75246 Blood Cancer And Stem Cell Transplant Clinic[Active, Not Recruiting]San Antonio, Texas, United States, 78229 Methodist Healthcare System Of San Antonio[Active, Not Recruiting]San Antonio, Texas, United States, 78229 Methodist Hospital Investigational Pharmacy[Active, Not Recruiting]San Antonio, Texas, United States, 78229|[Active, Not Recruiting]Seattle, Washington, United States, 98104 Swedish First Hill Ids Pharmacy[Active, Not Recruiting]Seattle, Washington, United States, 98104 Swedish Medical Center[Active, Not Recruiting]Seattle, Washington, United States, 98122","California|Georgia|Massachusetts|Missouri|New York|Ohio|Oregon|Tennessee|Texas|Washington","Australia|Austria|Belgium|Canada|China|Czechia|France|Georgia|Germany|Hungary|Israel|Italy|Japan|Mexico|Poland|Romania|Spain|Sweden|United Kingdom|United States","Australia, 5000 Royal Adelaide Hospital|New South Wales St Vincent's Hospital Sydney|Royal Adelaide Hospital - Clinical Trials Pharmacy|Landeskrankenhaus Salzburg, Universitatsklinik Fur Innere Medizin Iii Der Pmu|Az Sint-Jan Brugge-Oostende Av|Manitoba Health Sciences Centre|Ontario Sunnybrook Research Institute|Quebec Ciusss De L'Est-De-L'Ile-De- MontrÃ©al - HÃ´pital Maisonneuve-Rosemont|Saskatchewan Royal University Hospital|Anhui The First Affiliated Hospital Of Ustc, Anhui Province Hospital|Fujian Fujian Medical University Union Hospital|Guangdong Guangdong Provincial People's Hospital|Hebei Hebei Yanda Lu Daopei Hospital|Henan Henan Provincial People's Hospital/Hematology Department|Hospital, Sichuan University|Hubei Tongji Hospital, Tongji Medical College, Huazhong University Of Science & Technology/Cancer Center|Ruijin Hospital Affiliated To Shanghai Jiaotong University School Of Medicine|Tianjin Institute Of Hematology And Blood Diseases Hospital, Chinese Academy Of Medical Sciences|Zhejiang The First Affiliated Hospital College Of Medicine, Zhejiang University|Interni Hematologicka A Onkologicka Klinika, Fakultni Nemocnice Brno|Chu Henri Mondor|Cancer Center At Augusta University|Bavaria Klinikum Der Universitaet Muenchen|Hesse Philipps-Universitaet Marburg|North Rhine Westphalia UniversitÃ¤tsklinikum KÃ¶ln|North Rhine-Westphalia Universitaetsklinikum Muenster|North-Rhine-Westphalia Universitaetsklinikum Muenster|Universitaetsklinikum Hamburg-Eppendorf|Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Klinika, Hematologia Tanszek|Rambam Health Care Campus|An Sod Farmacia-Dipt Dei Servizi -Aou Ospedali Riuniti Umberto I, G.M. Lancisi, G. Salesi|Ancona Aou Ospedali Riuniti Umberto I, G.M. Lancisi, G. Salesi, Clinica Di Ematologia|Azienda Ospedaliero Universitaria Di Bologna Policlinico S.Orsola Malpighi|Fe A.O.U. Di Ferrara- Arcispedale Sant'Anna,|Pu Ao Ospedali Riuniti Marche Nord - Presidio Ospedaliero San Salvatore Di Pesaro -|Si Azienda Ospedaliera Universitaria Senese.|Aichi Japanese Red Cross Nagoya Daini Hospital|Akita University Hospital|Fukui University Of Fukui Hospital|Gunma Gunma University Hospital|Hyogo Kobe University Hospital|Kanagawa Yokohama City University Medical Center|Miyagi Tohoku University Hospital|Osaka Osaka City University Hospital|Shizuoka Shizuoka Cancer Center|Tokyo National Hospital Organization Disaster Medical Center|MÃ©x Instituto Nacional De CancerologÃ­a|Nuevo Leon Hospital Unversitario \"Dr. Jose Eleuterio Gonzalez\"|Klinika Hematologii I Transplantologii Uniwersyteckie Centrum Kliniczne|Cluj Institutul Oncologic 'Prof. Dr. Ion Chiricuta'|Dolj Spitalul Clinic Municipal Filantropia Craiova, Sectia Clinica Hematologie|Spitalul Universitar De Urgenta Militar Central \"Dr. Carol Davila\" Bucuresti|Hospital Del Mar|Apoex Vn|, Surrey The Royal Marsden Nhs Foundation Trust|, West Midlands University Hospitals Birmingham Nhs Foundation Trust|Imperial College Healthcare Nhs Trust|Rrmc - Ucla|Augusta University Medical Center Clinical Research Pharmacy|Tufts Medical Center Investigational Pharmacy|Midamerica Division, Inc., C/O Research Medical Center|Northwell Health/Monter Cancer Center|Taussig Cancer Center Investigational Pharmacy|Ohsu Center For Health And Healing|Centennial Medical Center|Baylor Scott And White Research Institute|Swedish Cancer Institute",{"$nulls":3},"Pfizer CT.gov Call Center","2020-04-24","2020-05-25T16:39:41.524","2020-05-26T17:10:42.972","NCT03416179"]
["5ecbf4cefe30261b1a0483c9","NCT03416374","2018-07-10","Takeda","TAK","Recruiting","A Study to Evaluate the Efficacy and Safety of Ixazomib in Combination With Lenalidomide and Dexamethasone in Patients With Relapsed and/or Refractory Multiple Myeloma Initially Treated With an Injection of Proteasome Inhibitor-Based Therapy","Ixazomib|Bortezomib|Carfilzomib|Lenalidomide|Dexamethasone","Proteasome Inhibitor|Angiogenesis Inhibitor|GR Agonist","No",null,"No",null,"Phase 4",1,47,"Anticipated","2018-02-01","2020-01-31","PFS","Progression Free Survival",{"$nulls":3},"The purpose of this study is to investigate the efficacy and safety of long-term administration of the oral proteasome inhibitor ixazomib as part of ixazomib in combination with lenalidomide and dexamethasone (IRd) therapy in patients with relapsed and/or refractory multiple myeloma (RRMM) treated initially with an injectable proteasome inhibitor-based therapy.","The drug being tested in this study is called Ixazomib. Ixazomib is being tested to treat people who have RRMM. This study will look at the effectiveness and safety of IRd in participants with RRMM previously receiving an injectable proteasome inhibitor-based therapy. This study consists of two treatment periods, Treatment Period I and Treatment Period II.\n\nThe study will enroll 47 patients. All participants will receive following treatment:\n\n- Combination therapy with Bortezomib + Lenalidomide + Dexamethasone (VRd) or combination therapy with Carfilzomib + Lenalidomide + Dexamethasone (KRd), standard recommended dose according to the package insert of each drug, as Treatment Period I, followed by Combination therapy with Ixazomib 4.0 mg + Lenalidomide 25 mg + Dexamethasone 40 mg (IRd) as Treatment Period II\n\nAt start of this study, combination therapy of VRd or KRd will be decided by investigator as Treatment Period I after the baseline evaluations. After the start of Treatment Period I, a participant's eligibility for Treatment Period II is then determined 3 cycles. Participants who meet these eligibility criteria II subsequently continue into Treatment Period II and receive IRd.\n\nThis multi-center trial will be conducted in Japan. It is anticipated that the treatment phase of this study will last up to 39 months, including 12 months for enrollment, and a 27-month treatment period for the last participant enrolled. Participants will make multiple visits to the clinic in treatment period, and follow-up period including a follow-up assessment after last dose of study drug.","An Open-label, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of Ixazomib in Combination With Lenalidomide and Dexamethasone in Patients With Relapsed and/or Refractory Multiple Myeloma Initially Treated With an Injection of Proteasome Inhibitor-Based Therapy","C16043","Relapsed and/or Refractory Multiple Myeloma","Multiple Myeloma","Oncology Hematological","Oncology","Experimental","Combination Therapy + Ixazomib Therapy","Bortezomib + Lenalidomide + Dexamethasone, or Carfilzomib + Lenalidomide + Dexamethasone, standard recommended dose according to the package insert of each drug (Treatment Period I), followed by Ixazomib (4.0 mg) on Days 1, 8 and 15, plus Lenalidomide (25 mg) on Days 1 to 21, and Dexamethasone (40 mg) on Days 1, 8, 15 and 22, of a 28-day cycle (Treatment Period II)","Drug","Ixazomib|Bortezomib|Carfilzomib|Lenalidomide|Dexamethasone","Ixazomib capsules|Bortezomib injections|Carfilzomib intravenous infusions|Lenalidomide capsules|Dexamethasone tablets",null,"Combination Therapy + Ixazomib Therapy","\n\nEligibility for Treatment Period I\n\n 1. Men and women of age 20 years or older at the time of enrollment.\n 2. Participants with RRMM.\n 3. Participants who are planned to start combination therapy with bortezomib, lenalidomide, and dexamethasone (VRd) or carfilzomib, lenalidomide, and dexamethasone (KRd) as second, third or fourth line of treatment.\n 4. Participants with measurable disease defined by one or more of the following three measurements. * Serum M-protein: â‰¥1 gram (g)/ deciliter (dL) (â‰¥ 10 g/ liter [L])\n     * Urine M-protein: â‰¥ 200 milligram (mg)/24 hours\n     * Serum free light chain assay: involved free light chain concentration â‰¥ 10 mg/dL (â‰¥ 100 mg/L) provided that the serum free light chain ratio is abnormal\n    \n    \n 5. Participants with Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2; however, participants with ECOG PS 3 are eligible if they only have symptoms associated with bone lesions.\n 6. Participants who are considered by the principal investigator or investigator not to be eligible for transplant; or, if considered eligible for transplant, participants who are planned not to undergo transplant for at least 12 months after the start of the study treatment.\n 7. Participants must be registered with, and comply with, the guidelines of the lenalidomide management program.\n 8. Participants who, before implementing procedures related to clinical research (excluding standard medical practices), understand that they can withdraw consent at any time without suffering from disadvantages to future treatments, and can provide written informed consent.Eligibility for Treatment Period II\n    \n    \n 9. Participants must have received an injectable proteasome inhibitor (bortezomib or carfilzomib) in each treatment cycle of Treatment Period I.\n\n","\n\nEligibility for Treatment Period I\n\n 1.  Women who are nursing or pregnant.\n 2.  Participants with another active malignancy, i.e. synchronous active malignancy or previous malignancy with a disease-free period of less than 5 years, except for participants with carcinoma in situ (intraepithelial carcinoma) or intramucosal carcinoma judged to be cured by topical treatment.\n 3.  Participants with poorly controlled active thrombosis.\n 4.  Participants who have participated in a clinical trial of ixazomib or have been treated with ixazomib.\n 5.  Participants who were refractory to either treatment regimen based on lenalidomide and/or proteasome inhibitor(s).Note: Refractory MM is defined as PD on therapy or PD within 60 days after the last dose of a given therapy. Participants who have disease progressed 60 days after the last dose of a given therapy will be considered as relapsed in this study.\n     \n     \n 6.  Participants with ongoing or active systemic infection, known hepatitis B virus infection, known hepatitis C virus infection, or known positivity to human immunodeficiency virus (HIV).\n 7.  Participants who underwent major surgery within 14 days prior to enrollment to Treatment Period I. Surgery for bone lesions is not considered as major surgery.\n 8.  Participants who received radiation therapy within 14 days prior to enrollment to Treatment Period I. If the radiation field is small, 7 days is considered as a sufficient interval between radiation therapy and chemotherapy.\n 9.  Participants who experience Grade 1 peripheral neuropathy accompanied by pain, or Grade â‰¥2 peripheral neuropathy.\n 10. Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmia, symptomatic congestive heart failure, unstable angina, or myocardial infarction within the past 6 months before enrollment to Treatment Period I.\n 11. Infection requiring systemic antibiotic therapy or other serious infection within 14 days before enrollment into Treatment Period I.\n 12. Participants with central nervous system involvement.\n 13. Inability to swallow oral medications, inability or unwillingness to comply with the drug administration requirements, or gastrointestinal conditions that could interfere with the oral absorption or tolerance of treatment.\n 14. Psychiatric illness/social situation that would limit compliance with study requirements.\n 15. Comorbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the participant inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.Eligibility for Treatment Period II\n     \n     \n 16. Participants who do not achieve at least a minimal response (MR) to VRd or KRd in Treatment Period I per the International Myeloma Working Group (IMWG) response criteria, 2014 revision.\n 17. Participants who experience Grade 1 peripheral neuropathy accompanied by pain, or Grade â‰¥2 peripheral neuropathy during Treatment Period I.\n 18. Participants with evidence of uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmia, symptomatic congestive heart failure, unstable angina, or myocardial infarction during Treatment Period I.\n 19. Participants using potent CYP3A4 inducing agents (rifampicin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital), or gingko biloba or St. John's wort.\n 20. Participants with hypersensitivity to any of the IRd study medications, their analogs, or excipients contained in IRd.\n 21. Comorbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the participant inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.",{"$nulls":4},"Actual","2018-01-31","Actual","Anticipated","2021-05-31","Anticipated","2018-07-01","2018-01-23","2018-01-30","2018-07-09","No",null,"Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","20 Years",null,"All",null,"No","Yes",{"$nulls":3},"No","No",{"$nulls":17},"U1111-1207-0061|JapicCTI-183839","WHO|Registry Identifier: JapicCTI","Progression-Free Survival (PFS) Rate at 12 Months from the Start of Study Treatment","PFS rate is defined as the percentage of participants who are alive and have not had disease progression at 12 months after the date of first dose of treatment in Treatment Period I. PFS will be assessed by International Myeloma Working Group (IMWG) Criteria (2014 version). Per IMWG criteria, PD: serum M-component increase â‰¥0.5 g/dl or urine M-component increase â‰¥200 mg/24-hour/ difference between involved and uninvolved FLC levels increase >10 mg/dl or bone marrow plasma cell â‰¥10%/ development of new/ increase in size of existing bone lesions or soft tissue plasmacytoma or development of hypercalcemia.","Up to 12 months","Overall Survival (OS) from the Start of Study Treatment|PFS from the Start of Study Treatment|Percentage of Participants who Achieved VGPR or Better (CR + VGPR)|Rate of Minimal Residual Disease (MRD) in Bone Marrow in Participants who Achieved CR|Percentage of Participants who Achieve or Maintain Any Best Response|Overall Response Rate (ORR)|Percentage of Participants Continuing Treatment with Ixazomib at 12 Months from the Start of Study Treatment|Duration of Response (DOR)|Patient-Reported Outcome Health-Related Quality of Life (HRQoL) based on European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-C30 (EORTC QLQ-C30)|Patient-Reported Outcome HRQoL based on EORTC Multiple Myeloma Module (EORTC QLQ-MY20) Score|Evaluation of modified Quality-Adjusted Life-Years (QALYs)|Healthcare Resource Utilization (HCRU)|Relative Dose Intensity (RDI)|Percentage of Participants with Bone Lesions (Bone Evaluation)|Number of Participants Reporting One or More Treatment-Emergent AEs (TEAEs)","OS is defined as the period from the first dose of treatment in Treatment Period I to the time when death (regardless of the cause of death) is confirmed. Patients who are still alive will be censored at the last confirmed date of survival or the date of data cut-off, whichever is earlier.|PFS is defined as the period from the first dose of treatment in Treatment Period I to the time of confirmed PD or confirmed death (regardless of the cause of death), whichever is earlier. PFS will be assessed by IMWG Criteria.|VGPR or better (CR + VGPR) will be assessed by IMWG Criteria. Per IMWG criteria, PR (partial response): â‰¥50% reduction of serum M protein+reduction in 24-hour urinary M protein by â‰¥90%/ to <200 mg/24-hour or â‰¥50% decrease in difference between involved and uninvolved free light chain (FLC) levels/ â‰¥50% reduction in bone marrow plasma cells, if â‰¥30% at baseline/ â‰¥50% reduction in size of soft tissue plasmacytomas. VGPR (very good PR): serum+urine M-protein detectable by immunofixation but not on electrophoresis/ â‰¥90% reduction in serum M-protein+urine M-protein level <100 mg/24-hour. CR (complete response): negative immunofixation on serum+urine+disappearance of soft tissue plasmacytomas+<5% plasma cells in bone marrow.|MRD is defined as the percentage of participants achieving CR who are MRD-negative. If a participant is MRD-positive at their first evaluation and MRD-negative after re-examination, the participant will be considered to be MRD-negative. CR will be assessed by IMWG Criteria.|Best response is defined as the cumulative numbers of participants who achieve each level of best response including PR, VGPR and CR assessed with IMWG Criteria, after each cycle of treatment.|ORR is defined as the percentage of participants who achieve a best response of PR or better including stringent complete response (sCR), VGPR and PR assessed with IMWG Criteria, after the start of the study treatment.|12 months|DOR is defined as the time from the date of first documentation of response â‰¥PR to the date of first documentation of PD or death due to any cause. PR and PD will be assessed with IMWG Criteria.|EORTC QLQ-C30 contains 30 items across 5 functional scales (physical, role, cognitive, emotional, and social), 9 symptom scales (fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and financial difficulties) and a global health status/QOL scale. EORTC QLQ-C30 contains 28 questions (4-point scale where 1=Not at all|EORTC QLQ-MY20 has 20 items across 4 independent subscales, 2 functional subscales (body image, future perspective), and 2 symptoms scales (disease symptoms, and side effects of treatment). Scores are averaged, and transformed to 0-100 scale. For the future perspective scale, higher score = better perspective of the future. For the body image scale, higher scores = better body image. Higher score for the disease symptoms scale = higher level of symptomatology.|Modified QALYs will be calculated from the score of EORTC QLQ-C30. The health-related quality of life scale score of EORTC QLQ-C30 will be converted into a utility value ranging from 0 to 1, and used to adjust the value of survival years; this value will be assessed as the modified QALY.|HCRU will be calculated from Exposure-adjusted rate of hospitalization events (per participants-months) and the duration of hospitalization among participants in Treatment Period I and Treatment Period II.|RDI for each study drug is defined as 100*(Total amount of dose taken)/(Total prescribed dose of treated cycles), where total prescribed dose equals|Up to 39 months as a maximum|An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.","Up to 39 months as a maximum|best to 4=Very Much|dose prescribed at enrollment* number of prescribed doses per cycle* the number of treated cycles.","medicalinformation@tpna.com","Takeda Study Registration Call Center",-5028,"Kamogawa, Chiba, Japan The Jikei University Kashiwa HospitalKashiwa, Chiba, Japan|Ogaki, Gifu, Japan|Maebashi, Gunma, Japan Shibukawa Medical CenterShibukawa, Gunma, Japan|Hiroshima, Japan Kyoto Kuramaguchi Medical CenterKyoto, Japan Niigata Cancer Center HospitalNiigata, Japan Osaka Red Cross HospitalOsaka, Japan|Kobe, Hyogo, Japan|Kanazawa, Ishikawa, Japan|Morioka, Iwate, Japan|Yokohama, Kanagawa, Japan|Suwa, Nagano, Japan|Koshigaya, Saitama, Japan|Bunkyo-Ku, Tokyo, Japan Nippon Medical School HospitalBunkyo-Ku, Tokyo, Japan Nihon University Itabashi HospitalItabashi-Ku, Tokyo, Japan The Cancer Institute Hospital Of JfcrKoto-Ku, Tokyo, Japan The Jikei University HospitalMinato-Ku, Tokyo, Japan Kyorin University HospitalMitaka, Tokyo, Japan Japanese Red Cross Medical CenterShibuya-Ku, Tokyo, Japan Tokyo Disaster Medical CenterTachikawa, Tokyo, Japan",null,"Japan","Chiba Kameda Medical Center|Gifu Ogaki Municipal Hospital|Gunma Gunma University Hospital|Hiroshima Red Cross Hospital & Atomic-Bomb Survivors Hospital|Hyogo Kobe City Medical Center General Hospital|Ishikawa Kanazawa University Hospital|Iwate Iwate Medical University|Kanagawa Yokohama Municipal Citizen's Hospital|Nagano Suwa Red Cross Hospital|Saitama Dokkyo Medical University|Tokyo Juntendo University Hospital",{"$nulls":3},"Study Director","2018-07-09","2020-05-25T16:39:42.602","2020-05-26T17:10:42.972","NCT03416374"]
["5ecbf4ce307e3d1b1f8d9e5a","NCT03416374","2018-07-23","Takeda","TAK","Recruiting","A Study to Evaluate the Efficacy and Safety of Ixazomib in Combination With Lenalidomide and Dexamethasone in Patients With Relapsed and/or Refractory Multiple Myeloma Initially Treated With an Injection of Proteasome Inhibitor-Based Therapy","Ixazomib|Bortezomib|Carfilzomib|Lenalidomide|Dexamethasone","Proteasome Inhibitor|Angiogenesis Inhibitor|GR Agonist","No",null,"No",null,"Phase 4",1,47,"Anticipated","2018-03-13","2020-02-28","PFS","Progression Free Survival",{"$nulls":3},"The purpose of this study is to investigate the efficacy and safety of long-term administration of the oral proteasome inhibitor ixazomib as part of ixazomib in combination with lenalidomide and dexamethasone (IRd) therapy in patients with relapsed and/or refractory multiple myeloma (RRMM) treated initially with an injectable proteasome inhibitor-based therapy.","The drug being tested in this study is called Ixazomib. Ixazomib is being tested to treat people who have RRMM. This study will look at the effectiveness and safety of IRd in participants with RRMM previously receiving an injectable proteasome inhibitor-based therapy. This study consists of two treatment periods, Treatment Period I and Treatment Period II.\n\nThe study will enroll 47 patients. All participants will receive following treatment:\n\n- Combination therapy with Bortezomib + Lenalidomide + Dexamethasone (VRd) or combination therapy with Carfilzomib + Lenalidomide + Dexamethasone (KRd), standard recommended dose according to the package insert of each drug, as Treatment Period I, followed by Combination therapy with Ixazomib 4.0 mg + Lenalidomide 25 mg + Dexamethasone 40 mg (IRd) as Treatment Period II\n\nAt start of this study, combination therapy of VRd or KRd will be decided by investigator as Treatment Period I after the baseline evaluations. After the start of Treatment Period I, a participant's eligibility for Treatment Period II is then determined 3 cycles. Participants who meet these eligibility criteria II subsequently continue into Treatment Period II and receive IRd.\n\nThis multi-center trial will be conducted in Japan. It is anticipated that the treatment phase of this study will last up to 39 months, including 12 months for enrollment, and a 27-month treatment period for the last participant enrolled. Participants will make multiple visits to the clinic in treatment period, and follow-up period including a follow-up assessment after last dose of study drug.","An Open-label, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of Ixazomib in Combination With Lenalidomide and Dexamethasone in Patients With Relapsed and/or Refractory Multiple Myeloma Initially Treated With an Injection of Proteasome Inhibitor-Based Therapy","C16043","Relapsed and/or Refractory Multiple Myeloma","Multiple Myeloma","Oncology Hematological","Oncology","Experimental","Combination Therapy + Ixazomib Therapy","Bortezomib + Lenalidomide + Dexamethasone, or Carfilzomib + Lenalidomide + Dexamethasone, standard recommended dose according to the package insert of each drug (Treatment Period I), followed by Ixazomib (4.0 mg) on Days 1, 8 and 15, plus Lenalidomide (25 mg) on Days 1 to 21, and Dexamethasone (40 mg) on Days 1, 8, 15 and 22, of a 28-day cycle (Treatment Period II)","Drug","Ixazomib|Bortezomib|Carfilzomib|Lenalidomide|Dexamethasone","Ixazomib capsules|Bortezomib injections|Carfilzomib intravenous infusions|Lenalidomide capsules|Dexamethasone tablets",null,"Combination Therapy + Ixazomib Therapy","\n\nEligibility for Treatment Period I\n\n 1. Men and women of age 20 years or older at the time of enrollment.\n 2. Participants with RRMM.\n 3. Participants who are planned to start combination therapy with bortezomib, lenalidomide, and dexamethasone (VRd) or carfilzomib, lenalidomide, and dexamethasone (KRd) as second, third or fourth line of treatment.\n 4. Participants with measurable disease defined by one or more of the following three measurements. * Serum M-protein: â‰¥1 gram (g)/ deciliter (dL) (â‰¥ 10 g/ liter [L])\n     * Urine M-protein: â‰¥ 200 milligram (mg)/24 hours\n     * Serum free light chain assay: involved free light chain concentration â‰¥ 10 mg/dL (â‰¥ 100 mg/L) provided that the serum free light chain ratio is abnormal\n    \n    \n 5. Participants with Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2; however, participants with ECOG PS 3 are eligible if they only have symptoms associated with bone lesions.\n 6. Participants who are considered by the principal investigator or investigator not to be eligible for transplant; or, if considered eligible for transplant, participants who are planned not to undergo transplant for at least 12 months after the start of the study treatment.\n 7. Participants must be registered with, and comply with, the guidelines of the lenalidomide management program.\n 8. Participants who, before implementing procedures related to clinical research (excluding standard medical practices), understand that they can withdraw consent at any time without suffering from disadvantages to future treatments, and can provide written informed consent.Eligibility for Treatment Period II\n    \n    \n 9. Participants must have received an injectable proteasome inhibitor (bortezomib or carfilzomib) in each treatment cycle of Treatment Period I.\n\n","\n\nEligibility for Treatment Period I\n\n 1.  Women who are nursing or pregnant.\n 2.  Participants with another active malignancy, i.e. synchronous active malignancy or previous malignancy with a disease-free period of less than 5 years, except for participants with carcinoma in situ (intraepithelial carcinoma) or intramucosal carcinoma judged to be cured by topical treatment.\n 3.  Participants with poorly controlled active thrombosis.\n 4.  Participants who have participated in a clinical trial of ixazomib or have been treated with ixazomib.\n 5.  Participants who were refractory to either treatment regimen based on lenalidomide and/or proteasome inhibitor(s).Note: Refractory MM is defined as PD on therapy or PD within 60 days after the last dose of a given therapy. Participants who have disease progressed 60 days after the last dose of a given therapy will be considered as relapsed in this study.\n     \n     \n 6.  Participants with ongoing or active systemic infection, known hepatitis B virus infection, known hepatitis C virus infection, or known positivity to human immunodeficiency virus (HIV).\n 7.  Participants who underwent major surgery within 14 days prior to enrollment to Treatment Period I. Surgery for bone lesions is not considered as major surgery.\n 8.  Participants who received radiation therapy within 14 days prior to enrollment to Treatment Period I. If the radiation field is small, 7 days is considered as a sufficient interval between radiation therapy and chemotherapy.\n 9.  Participants who experience Grade 1 peripheral neuropathy accompanied by pain, or Grade â‰¥2 peripheral neuropathy.\n 10. Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmia, symptomatic congestive heart failure, unstable angina, or myocardial infarction within the past 6 months before enrollment to Treatment Period I.\n 11. Infection requiring systemic antibiotic therapy or other serious infection within 14 days before enrollment into Treatment Period I.\n 12. Participants with central nervous system involvement.\n 13. Inability to swallow oral medications, inability or unwillingness to comply with the drug administration requirements, or gastrointestinal conditions that could interfere with the oral absorption or tolerance of treatment.\n 14. Psychiatric illness/social situation that would limit compliance with study requirements.\n 15. Comorbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the participant inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.Eligibility for Treatment Period II\n     \n     \n 16. Participants who do not achieve at least a minimal response (MR) to VRd or KRd in Treatment Period I per the International Myeloma Working Group (IMWG) response criteria, 2014 revision.\n 17. Participants who experience Grade 1 peripheral neuropathy accompanied by pain, or Grade â‰¥2 peripheral neuropathy during Treatment Period I.\n 18. Participants with evidence of uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmia, symptomatic congestive heart failure, unstable angina, or myocardial infarction during Treatment Period I.\n 19. Participants using potent CYP3A4 inducing agents (rifampicin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital), or gingko biloba or St. John's wort.\n 20. Participants with hypersensitivity to any of the IRd study medications, their analogs, or excipients contained in IRd.\n 21. Comorbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the participant inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.",{"$nulls":4},"Actual","2018-01-31","Actual","Anticipated","2021-05-31","Anticipated","2018-07-01","2018-01-23","2018-01-30","2018-07-20","No",null,"Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","20 Years",null,"All",null,"No","Yes",{"$nulls":3},"No","No",{"$nulls":17},"U1111-1207-0061|JapicCTI-183839","WHO|Registry Identifier: JapicCTI","Progression-Free Survival (PFS) Rate at 12 Months from the Start of Study Treatment","PFS rate is defined as the percentage of participants who are alive and have not had disease progression at 12 months after the date of first dose of treatment in Treatment Period I. PFS will be assessed by International Myeloma Working Group (IMWG) Criteria (2014 version). Per IMWG criteria, PD: serum M-component increase â‰¥0.5 g/dl or urine M-component increase â‰¥200 mg/24-hour/ difference between involved and uninvolved FLC levels increase >10 mg/dl or bone marrow plasma cell â‰¥10%/ development of new/ increase in size of existing bone lesions or soft tissue plasmacytoma or development of hypercalcemia.","Up to 12 months","Overall Survival (OS) from the Start of Study Treatment|PFS from the Start of Study Treatment|Percentage of Participants who Achieved VGPR or Better (CR + VGPR)|Rate of Minimal Residual Disease (MRD) in Bone Marrow in Participants who Achieved CR|Percentage of Participants who Achieve or Maintain Any Best Response|Overall Response Rate (ORR)|Percentage of Participants Continuing Treatment with Ixazomib at 12 Months from the Start of Study Treatment|Duration of Response (DOR)|Patient-Reported Outcome Health-Related Quality of Life (HRQoL) based on European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-C30 (EORTC QLQ-C30)|Patient-Reported Outcome HRQoL based on EORTC Multiple Myeloma Module (EORTC QLQ-MY20) Score|Evaluation of modified Quality-Adjusted Life-Years (QALYs)|Healthcare Resource Utilization (HCRU)|Relative Dose Intensity (RDI)|Percentage of Participants with Bone Lesions (Bone Evaluation)|Number of Participants Reporting One or More Treatment-Emergent AEs (TEAEs)","OS is defined as the period from the first dose of treatment in Treatment Period I to the time when death (regardless of the cause of death) is confirmed. Patients who are still alive will be censored at the last confirmed date of survival or the date of data cut-off, whichever is earlier.|PFS is defined as the period from the first dose of treatment in Treatment Period I to the time of confirmed PD or confirmed death (regardless of the cause of death), whichever is earlier. PFS will be assessed by IMWG Criteria.|VGPR or better (CR + VGPR) will be assessed by IMWG Criteria. Per IMWG criteria, PR (partial response): â‰¥50% reduction of serum M protein+reduction in 24-hour urinary M protein by â‰¥90%/ to <200 mg/24-hour or â‰¥50% decrease in difference between involved and uninvolved free light chain (FLC) levels/ â‰¥50% reduction in bone marrow plasma cells, if â‰¥30% at baseline/ â‰¥50% reduction in size of soft tissue plasmacytomas. VGPR (very good PR): serum+urine M-protein detectable by immunofixation but not on electrophoresis/ â‰¥90% reduction in serum M-protein+urine M-protein level <100 mg/24-hour. CR (complete response): negative immunofixation on serum+urine+disappearance of soft tissue plasmacytomas+<5% plasma cells in bone marrow.|MRD is defined as the percentage of participants achieving CR who are MRD-negative. If a participant is MRD-positive at their first evaluation and MRD-negative after re-examination, the participant will be considered to be MRD-negative. CR will be assessed by IMWG Criteria.|Best response is defined as the cumulative numbers of participants who achieve each level of best response including PR, VGPR and CR assessed with IMWG Criteria, after each cycle of treatment.|ORR is defined as the percentage of participants who achieve a best response of PR or better including stringent complete response (sCR), VGPR and PR assessed with IMWG Criteria, after the start of the study treatment.|12 months|DOR is defined as the time from the date of first documentation of response â‰¥PR to the date of first documentation of PD or death due to any cause. PR and PD will be assessed with IMWG Criteria.|EORTC QLQ-C30 contains 30 items across 5 functional scales (physical, role, cognitive, emotional, and social), 9 symptom scales (fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and financial difficulties) and a global health status/QOL scale. EORTC QLQ-C30 contains 28 questions (4-point scale where 1=Not at all|EORTC QLQ-MY20 has 20 items across 4 independent subscales, 2 functional subscales (body image, future perspective), and 2 symptoms scales (disease symptoms, and side effects of treatment). Scores are averaged, and transformed to 0-100 scale. For the future perspective scale, higher score = better perspective of the future. For the body image scale, higher scores = better body image. Higher score for the disease symptoms scale = higher level of symptomatology.|Modified QALYs will be calculated from the score of EORTC QLQ-C30. The health-related quality of life scale score of EORTC QLQ-C30 will be converted into a utility value ranging from 0 to 1, and used to adjust the value of survival years; this value will be assessed as the modified QALY.|HCRU will be calculated from Exposure-adjusted rate of hospitalization events (per participants-months) and the duration of hospitalization among participants in Treatment Period I and Treatment Period II.|RDI for each study drug is defined as 100*(Total amount of dose taken)/(Total prescribed dose of treated cycles), where total prescribed dose equals|Up to 39 months as a maximum|An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.","Up to 39 months as a maximum|best to 4=Very Much|dose prescribed at enrollment* number of prescribed doses per cycle* the number of treated cycles.","medicalinformation@tpna.com","Takeda Study Registration Call Center",-5028,"Kamogawa, Chiba, Japan The Jikei University Kashiwa HospitalKashiwa, Chiba, Japan|Ogaki, Gifu, Japan|Maebashi, Gunma, Japan Shibukawa Medical CenterShibukawa, Gunma, Japan|Hiroshima, Japan Kyoto Kuramaguchi Medical CenterKyoto, Japan Niigata Cancer Center HospitalNiigata, Japan Osaka Red Cross HospitalOsaka, Japan|Kobe, Hyogo, Japan|Kanazawa, Ishikawa, Japan|Morioka, Iwate, Japan|Yokohama, Kanagawa, Japan|Suwa, Nagano, Japan|Koshigaya, Saitama, Japan|Bunkyo-Ku, Tokyo, Japan Nippon Medical School HospitalBunkyo-Ku, Tokyo, Japan Nihon University Itabashi HospitalItabashi-Ku, Tokyo, Japan The Cancer Institute Hospital Of JfcrKoto-Ku, Tokyo, Japan The Jikei University HospitalMinato-Ku, Tokyo, Japan Kyorin University HospitalMitaka, Tokyo, Japan Japanese Red Cross Medical CenterShibuya-Ku, Tokyo, Japan Tokyo Disaster Medical CenterTachikawa, Tokyo, Japan",null,"Japan","Chiba Kameda Medical Center|Gifu Ogaki Municipal Hospital|Gunma Gunma University Hospital|Hiroshima Red Cross Hospital & Atomic-Bomb Survivors Hospital|Hyogo Kobe City Medical Center General Hospital|Ishikawa Kanazawa University Hospital|Iwate Iwate Medical University|Kanagawa Yokohama Municipal Citizen's Hospital|Nagano Suwa Red Cross Hospital|Saitama Dokkyo Medical University|Tokyo Juntendo University Hospital",{"$nulls":3},"Study Director","2018-07-20","2020-05-25T16:39:42.039","2020-05-26T17:10:42.972","NCT03416374"]
["5ecbf4d2e2561b1b11905ecd","NCT03417037","2018-02-01","Bristol-Myers Squibb","BMY","Not yet recruiting","An Immuno-Therapy Study of Experimental Medication BMS-986205 Given With Nivolumab With or Without Chemotherapy Compared to Chemotherapy in Participants With Previously Untreated Stage IV or Recurrent Non-Small Cell Lung Cancer","Bms-986205|Nivolumab","IDO1 Inhibitor|PD-1 Inhibitor","Yes","['Bms-986205']","Yes","['IDO1 Inhibitor']","Phase 3",3,1174,"Anticipated","2018-02-24","2021-01-26","RR|BOR|PFS|CR|TTP","Response Rate|Best Overall Response|Progression Free Survival|Complete Response|Time to Progression",{"$nulls":3},"This is a study of experimental medication BMS-986205 given with Nivolumab with or without chemotherapy compared to chemotherapy in participants with previously untreated stage IV or recurrent non-small cell lung cancer.",null,"A Phase 3 Open Label, Randomized Study of BMS-986205 Combined With Nivolumab With or Without Chemotherapy Versus Chemotherapy in Participants With Previously Untreated Stage IV or Recurrent Non-Small Cell Lung Cancer","CA017-062","Lung Cancer\nNon-Small Cell Lung Cancer","Lung Cancer|Small Cell Lung Cancer|Non-Small-Cell Lung Cancer","Oncology Solid Tumor","Oncology","Experimental|Active Comparator","Arm A|Arm B|Arm C","BMS-986205 and Nivolumab administered in combination|BMS-986205 and Nivolumab administered in combination with chemotherapy|Chemotherapy administered alone","Drug|Biological","BMS-986205|Nivolumab|Chemotherapy","Administered orally daily, 100 mg|Specified dose on specified days|Platinum-based doublet chemotherapy","Opdivo | BMS-936558","Arm A|Arm B|Arm C","\n\n * Histologically confirmed stage IV NSCLC per the 8th IASLC of squamous or nonsquamous histology\n * Locally advanced disease with recurrence after chemoradiation therapy (stage IIIB disease, specifically refers to patients with no curative treatment options)\n * No prior systemic anti-cancer therapy (including EGFR and ALK/ROS1 inhibitors) given as primary therapy for advanced or metastatic disease\n * Participants must have biomarker test results available for randomization\n * ECOG Performance Status of â‰¤ 1\n * Measurable disease by CT or MRI per RECIST 1.1 criteria\n\n","\n\n * Participants with known sensitizing EGFR mutations or known ALK/ROS1 rearrangements\n * Participants with interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity\n * Participants with an active, known or suspected autoimmune disease [Participants with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll]\n * Participants with untreated CNS metastases are excluded [Participants are eligible if CNS metastases are adequately treated and participants are neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to first treatment]\n\nOther protocol defined inclusion/exclusion criteria could apply","EGFR","epidermal growth factor receptor","Protein","Ovary, Breast, Lung","Actual","2018-01-31","Actual","Anticipated","2025-05-23","Anticipated","2018-01-01","2018-01-25","2018-01-25","2018-01-30",null,null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No",null,null,"URL: http://bms.com/studyconnect/Pages/home.aspx [http://bms.com/studyconnect/Pages/home.aspx] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: BMS Clinical Trial Patient Recruiting",null,"Yes","No",{"$nulls":17},"2017-003058-18","EudraCT Number","Objective response rate (ORR) measured by number of participants with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR) divided by the number of randomized participants for each treatment group|Progression free survival (PFS) measured by the time between the date of randomization and the first date of documented progression, as determined by the Blinded Independent Central Review, or death, due to any cause, whichever occurs first","24 months|34 months",null,"Overall survival (OS) measured by the time between the date of randomization and the date of death due to any cause|Number of treatment-related adverse events (AE)|Number of treatment-related serious adverse events","Approximately 5 years",null,"Clinical.Trials@bms.com","Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,","please email:","Vienna, Austria, 1090|Rio De Janeiro, Brazil, 22793-080|Ipatinga, Minas Gerais, Brazil, 35160-158|Jd. Petropolis-Londrina, Parana, Brazil, 86015-520|Centro-Porto Alegre, Rio Grande Do Sul, Brazil, 90050-170|Barretos, Sao Paulo, Brazil, 14780-070|Paris Cedex 5, France, 75248|Berlin, Germany, 14165|Modena, Italy, 41100|Fukushima-Shi, Fukushima, Japan, 9601295|Morioka-Shi, Iwate, Japan, 0208505|Osaka-Sayama-Shi, Osaka, Japan, 5898511|Kitaadachi-Gun, Saitama, Japan, 362-0806|Merida, Yucatan, Mexico, 97070|A Coruna, Galicia, Spain, 15006|Barcelona, Spain, 08035|Basel, Switzerland, 4031|Adana, Turkey, 01250|San Diego, California, United States, 92123|Jacksonville, Florida, United States, 32256|Decatur, Georgia, United States, 30033|Wichita, Kansas, United States, 67214|Boston, Massachusetts, United States, 02114|Bridgeton, Missouri, United States, 63044|Lincoln, Nebraska, United States, 68510|Cleveland, Ohio, United States, 44106|Gettysburg, Pennsylvania, United States, 17325|Greenville, South Carolina, United States, 29607|Fort Worth, Texas, United States, 76104","California|Florida|Georgia|Kansas|Massachusetts|Missouri|Nebraska|Ohio|Pennsylvania|South Carolina|Texas","Austria|Brazil|France|Germany|Italy|Japan|Mexico|Spain|Switzerland|Turkey|United States","Local Institution|Minas Gerais Local Institution|Parana Local Institution|Rio Grande Do Sul Local Institution|Sao Paulo Local Institution|Fukushima Local Institution|Iwate Local Institution|Osaka Local Institution|Saitama Local Institution|Yucatan Local Institution|Galicia Local Institution",null,"First line of the email MUST contain NCT # and Site #.",null,"Bristol-Myers Squibb","2018-01-30","2020-05-25T16:39:46.155","2020-05-26T17:10:42.972","NCT03417037"]
["5ecbf4d2307e3d1b1f8d9e64","NCT03417037","2018-03-16","Bristol-Myers Squibb","BMY","Not yet recruiting","An Immuno-Therapy Study of Experimental Medication BMS-986205 Given With Nivolumab With or Without Chemotherapy Compared to Chemotherapy in Participants With Previously Untreated Stage IV or Recurrent Non-Small Cell Lung Cancer","Bms-986205|Nivolumab","IDO1 Inhibitor|PD-1 Inhibitor","Yes","['Bms-986205']","Yes","['IDO1 Inhibitor']","Phase 3",3,1174,"Anticipated","2018-05-24","2021-04-25","RR|BOR|PFS|CR|TTP","Response Rate|Best Overall Response|Progression Free Survival|Complete Response|Time to Progression",{"$nulls":3},"This is a study of experimental medication BMS-986205 given with Nivolumab with or without chemotherapy compared to chemotherapy in participants with previously untreated stage IV or recurrent non-small cell lung cancer.",null,"A Phase 3 Open Label, Randomized Study of BMS-986205 Combined With Nivolumab With or Without Chemotherapy Versus Chemotherapy in Participants With Previously Untreated Stage IV or Recurrent Non-Small Cell Lung Cancer","CA017-062","Lung Cancer\nNon-Small Cell Lung Cancer","Lung Cancer|Small Cell Lung Cancer|Non-Small-Cell Lung Cancer","Oncology Solid Tumor","Oncology","Experimental|Active Comparator","Arm A|Arm B|Arm C","BMS-986205 and Nivolumab administered in combination|BMS-986205 and Nivolumab administered in combination with chemotherapy|Chemotherapy administered alone","Drug|Biological","BMS-986205|Nivolumab|Chemotherapy","Administered orally daily, 100 mg|Specified dose on specified days|Platinum-based doublet chemotherapy","Opdivo | BMS-936558","Arm A|Arm B|Arm C","\n\n * Histologically confirmed stage IV NSCLC per the 8th IASLC of squamous or nonsquamous histology\n * Locally advanced disease with recurrence after chemoradiation therapy (stage IIIB disease, specifically refers to patients with no curative treatment options)\n * No prior systemic anti-cancer therapy (including EGFR and ALK/ROS1 inhibitors) given as primary therapy for advanced or metastatic disease\n * Participants must have biomarker test results available for randomization\n * ECOG Performance Status of â‰¤ 1\n * Measurable disease by CT or MRI per RECIST 1.1 criteria\n\n","\n\n * Participants with known sensitizing EGFR mutations or known ALK/ROS1 rearrangements\n * Participants with interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity\n * Participants with an active, known or suspected autoimmune disease [Participants with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll]\n * Participants with untreated CNS metastases are excluded [Participants are eligible if CNS metastases are adequately treated and participants are neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to first treatment]\n\nOther protocol defined inclusion/exclusion criteria could apply","EGFR","epidermal growth factor receptor","Protein","Ovary, Breast, Lung","Actual","2018-01-31","Actual","Anticipated","2025-08-20","Anticipated","2018-03-01","2018-01-25","2018-01-25","2018-03-15",null,null,"Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No",null,null,"URL: http://bms.com/studyconnect/Pages/home.aspx [http://bms.com/studyconnect/Pages/home.aspx] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: BMS Clinical Trial Patient Recruiting",null,"Yes","No",{"$nulls":17},"2017-003058-18","EudraCT Number","Objective response rate (ORR) measured by number of participants with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR) divided by the number of randomized participants for each treatment group|Progression free survival (PFS) measured by the time between the date of randomization and the first date of documented progression, as determined by the Blinded Independent Central Review, or death, due to any cause, whichever occurs first","24 months|34 months",null,"Overall survival (OS) measured by the time between the date of randomization and the date of death due to any cause|Number of treatment-related adverse events (AE)|Number of treatment-related serious adverse events","Approximately 5 years",null,"Clinical.Trials@bms.com","Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,","please email:","Murdoch, Western|North Tamworth, Australia, 2340|Darlinghurst, New South Wales, Australia, 2010|Brisbane, Queensland, Australia, 4102|Melbourne, Victoria, Australia, 3004|Vienna, Austria, 1090|Rio De Janeiro, Brazil, 22793-080|Ipatinga, Minas Gerais, Brazil, 35160-158|Jd. Petropolis-Londrina, Parana, Brazil, 86015-520|Centro-Porto Alegre, Rio Grande Do Sul, Brazil, 90050-170|Barretos, Sao Paulo, Brazil, 14780-070|Quebec, Canada, G1R 2J6|Praha 2, Czechia, 128 08|Besancon, France, 25030|Berlin, Germany, 14165|Athens, Greece, 11527|Modena, Italy, 41100|Fukushima-Shi, Fukushima, Japan, 9601295|Morioka-Shi, Iwate, Japan, 0208505|Osaka-Sayama-Shi, Osaka, Japan, 5898511|Kitaadachi-Gun, Saitama, Japan, 362-0806|Merida, Yucatan, Mexico, 97070|A Coruna, Galicia, Spain, 15006|Barcelona, Spain, 08035|Basel, Switzerland, 4031|Adana, Turkey, 01250|San Diego, California, United States, 92123|Fort Myers, Florida, United States, 33916|Decatur, Georgia, United States, 30033|Wichita, Kansas, United States, 67214|Louisville, Kentucky, United States, 40202|Boston, Massachusetts, United States, 02114|Bridgeton, Missouri, United States, 63044|Lincoln, Nebraska, United States, 68510|Cleveland, Ohio, United States, 44106|Gettysburg, Pennsylvania, United States, 17325|Greenville, South Carolina, United States, 29607|Fort Worth, Texas, United States, 76104","California|Florida|Georgia|Kansas|Kentucky|Massachusetts|Missouri|Nebraska|Ohio|Pennsylvania|South Carolina|Texas","Australia|Austria|Brazil|Canada|Czechia|France|Germany|Greece|Italy|Japan|Mexico|Spain|Switzerland|Turkey|United States","Local Institution|New South Wales Local Institution|Queensland Local Institution|Victoria Local Institution|Minas Gerais Local Institution|Parana Local Institution|Rio Grande Do Sul Local Institution|Sao Paulo Local Institution|Fukushima Local Institution|Iwate Local Institution|Osaka Local Institution|Saitama Local Institution|Yucatan Local Institution|Galicia Local Institution",null,"First line of the email MUST contain NCT # and Site #.",null,"Bristol-Myers Squibb","2018-03-15","2020-05-25T16:39:46.176","2020-05-26T17:10:42.972","NCT03417037"]
["5ecbf4d211702c1b1b916be1","NCT03417102","2018-01-31","Alnylam","ALNY","Recruiting","A Study of Fitusiran (ALN-AT3SC) in Severe Hemophilia A and B Patients With Inhibitors","Fitusiran",null,"Yes","['Fitusiran']","Unknown",null,"Phase 3",2,54,"Anticipated","2018-01-08","2019-06-01","ABR","Annualized Bleeding Rate","Sanofi","Industry","SNY","The purpose of this study is to determine the frequency of bleeding episodes in patients receiving fitusiran as prophylactic treatment of hemophilia compared with patients who are assigned to continue with their regular medication. In addition, the study will assess safety, quality of life, pharmacodynamics (PD), and pharmacokinetics (PK).",null,"ATLAS-INH: A Phase 3 Study to Evaluate the Efficacy and Safety of Fitusiran in Patients With Hemophilia A or B, With Inhibitory Antibodies to Factor VIII or IX","ALN-AT3SC-003","Hemophilia A\nHemophilia B","Hemophilia A|Hemophilia B","Hematologic Diseases","Heme & Lymph Diseases","Experimental|Active Comparator","Fitusiran|On demand bypassing agents",null,"Drug","fitusiran|bypassing agent","by subcutaneous (SC) injection|by intravenous (IV) injection",null,"Fitusiran|On demand bypassing agents","\n\n * Males, â‰¥12 years of age\n * Severe hemophilia A or B with inhibitors * (Severity confirmed by a central laboratory where FVIII level is <1% or FIX level is â‰¤2% at Screening; Inhibitors defined as inhibitor titer of â‰¥0.6 BU/mL or as evidenced by medical records)\n   \n   \n * A minimum of 6 bleeding episodes requiring bypassing agent treatment within the last 6 months prior to Screening\n * Willing and able to comply with the study requirements and to provide written informed consent and assent\n\n","\n\n * Known co-existing bleeding disorders other than hemophilia A or B\n * Antithrombin (AT) activity <60% at Screening\n * Co-existing thrombophilic disorder\n * Clinically significant liver disease\n * Active HCV infection\n * HIV positive with a CD4 count of <200 cells/Î¼L\n * History of arterial or venous thromboembolism\n * Inadequate renal function\n * History of multiple drug allergies or history of allergic reaction to an oligonucleotide or N-Acetylgalactosamine (GalNAc)\n * History of intolerance to SC injection(s)\n * Any other conditions or comorbidities that would make the patient unsuitable for enrollment or could interfere with participation in or completion of the study, per Investigator judgement",{"$nulls":4},"Actual","2018-01-31","Actual","Anticipated","2019-07-01","Anticipated","2018-01-01","2018-01-25","2018-01-30","2018-01-30","Yes","RNAi therapeutic\nHemophilia A\nHemophilia B\nHemophilia A, Severe\nHemophilia B, Severe\nBlood Coagulation Disorders, Inherited\nBlood Coagulation Disorders\nHematologic Diseases\nCoagulation Protein Disorders\nHemorrhagic Disorders\nGenetic Diseases, Inborn\nGenetic Diseases, X-Linked\nFactor VIII\nFactor IX\nInhibitor\nBypassing agents\nCoagulants\nFitusiran","Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","12 Years",null,"Male",null,"No","Undecided",{"$nulls":3},"Yes","No",{"$nulls":19},"Annualized bleeding rate (ABR)","9 months",null,"Annualized spontaneous bleeding rate|Annualized joint bleeding rate|Haem-A-QOL Questionnaire score","9 months",null,"clinicaltrials@alnylam.com","Alnylam Clinical Trials","866-330-0326","Chapel Hill, North Carolina, United States, 27517","North Carolina","United States","Clinical Trial Site",{"$nulls":3},"Kate Madigan, MD","2018-01-30","2020-05-25T16:39:46.853","2020-05-26T17:10:42.972","NCT03417102"]
["5ecbf4d3307e3d1b1f8d9e66","NCT03417102","2018-04-09","Alnylam","ALNY","Recruiting","A Study of Fitusiran (ALN-AT3SC) in Severe Hemophilia A and B Patients With Inhibitors","Fitusiran",null,"Yes","['Fitusiran']","Unknown",null,"Phase 3",2,54,"Anticipated","2018-04-01","2019-06-01","ABR","Annualized Bleeding Rate","Sanofi","Industry","SNY","The purpose of this study is to determine the frequency of bleeding episodes in patients receiving fitusiran as prophylactic treatment of hemophilia compared with patients who are assigned to continue with their regular medication. In addition, the study will assess safety, quality of life, pharmacodynamics (PD), and pharmacokinetics (PK).",null,"ATLAS-INH: A Phase 3 Study to Evaluate the Efficacy and Safety of Fitusiran in Patients With Hemophilia A or B, With Inhibitory Antibodies to Factor VIII or IX","ALN-AT3SC-003","Hemophilia A\nHemophilia B","Hemophilia A|Hemophilia B","Hematologic Diseases","Heme & Lymph Diseases","Experimental|Active Comparator","Fitusiran|On demand bypassing agents",null,"Drug","fitusiran|recombinant Factor VIIa and FEIBA","by subcutaneous (SC) injection|by intravenous (IV) injection",null,"Fitusiran|On demand bypassing agents","\n\n * Males, â‰¥12 years of age\n * Severe hemophilia A or B with inhibitors * (Severity confirmed by a central laboratory where FVIII level is <1% or FIX level is â‰¤2% at Screening; Inhibitors defined as inhibitor titer of â‰¥0.6 BU/mL or as evidenced by medical records)\n   \n   \n * A minimum of 6 bleeding episodes requiring bypassing agent treatment within the last 6 months prior to Screening\n * Willing and able to comply with the study requirements and to provide written informed consent and assent\n\n","\n\n * Known co-existing bleeding disorders other than hemophilia A or B\n * Antithrombin (AT) activity <60% at Screening\n * Co-existing thrombophilic disorder\n * Clinically significant liver disease\n * Active HCV infection\n * HIV positive with a CD4 count of <200 cells/Î¼L\n * History of arterial or venous thromboembolism\n * Inadequate renal function\n * History of multiple drug allergies or history of allergic reaction to an oligonucleotide or N-Acetylgalactosamine (GalNAc)\n * History of intolerance to SC injection(s)\n * Any other conditions or comorbidities that would make the patient unsuitable for enrollment or could interfere with participation in or completion of the study, per Investigator judgement",{"$nulls":4},"Actual","2018-01-31","Actual","Anticipated","2019-07-01","Anticipated","2018-04-01","2018-01-25","2018-01-30","2018-04-06","Yes","RNAi therapeutic\nHemophilia A\nHemophilia B\nHemophilia A, Severe\nHemophilia B, Severe\nBlood Coagulation Disorders, Inherited\nBlood Coagulation Disorders\nHematologic Diseases\nCoagulation Protein Disorders\nHemorrhagic Disorders\nGenetic Diseases, Inborn\nGenetic Diseases, X-Linked\nFactor VIII\nFactor IX\nInhibitor\nBypassing agents\nCoagulants\nFitusiran","Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","12 Years",null,"Male",null,"No","Undecided",{"$nulls":3},"Yes","No",{"$nulls":19},"Annualized bleeding rate (ABR)","9 months",null,"Annualized spontaneous bleeding rate|Annualized joint bleeding rate|Quality of Life (QOL) as measured by Haem-A-QOL Questionnaire score on a scale of 0-100 with higher scores representing greater impairment.","9 months",null,"clinicaltrials@alnylam.com","Alnylam Clinical Trials","866-330-0326","Phoenix, Arizona, United States, 85016|Orange, California, United States, 92868|Tampa, Florida, United States, 33607|Las Vegas, Nevada, United States, 89109|Chapel Hill, North Carolina, United States, 27517","Arizona|California|Florida|Nevada|North Carolina","United States","Clinical Trial Site",{"$nulls":3},"Kate Madigan, MD","2018-04-06","2020-05-25T16:39:47.018","2020-05-26T17:10:42.972","NCT03417102"]
["5ecbf4d3feab101b15530a04","NCT03417102","2018-08-10","Sanofi","SNY","Recruiting","A Study of Fitusiran (ALN-AT3SC) in Severe Hemophilia A and B Patients With Inhibitors (ATLAS-INH)","Fitusiran",null,"Yes","['Fitusiran']","Unknown",null,"Phase 3",2,54,"Anticipated","2018-03-22","2019-06-01","ABR","Annualized Bleeding Rate",{"$nulls":3},"The purpose of this study is to determine the frequency of bleeding episodes in patients receiving fitusiran as prophylactic treatment of hemophilia compared with patients who are assigned to continue with their regular medication. In addition, the study will assess safety, quality of life, pharmacodynamics (PD), and pharmacokinetics (PK).",null,"ATLAS-INH: A Phase 3 Study to Evaluate the Efficacy and Safety of Fitusiran in Patients With Hemophilia A or B, With Inhibitory Antibodies to Factor VIII or IX","EFC14768","Hemophilia A\nHemophilia B","Hemophilia A|Hemophilia B","Hematologic Diseases","Heme & Lymph Diseases","Experimental|Active Comparator","Fitusiran|On demand bypassing agents",null,"Drug","fitusiran|recombinant Factor VIIa and FEIBA","by subcutaneous (SC) injection|by intravenous (IV) injection",null,"Fitusiran|On demand bypassing agents","\n\n * Males, â‰¥12 years of age\n * Severe hemophilia A or B with inhibitors * (Severity confirmed by a central laboratory where FVIII level is <1% or FIX level is â‰¤2% at Screening; Inhibitors defined as inhibitor titer of â‰¥0.6 BU/mL or as evidenced by medical records)\n   \n   \n * A minimum of 6 bleeding episodes requiring bypassing agent treatment within the last 6 months prior to Screening\n * Willing and able to comply with the study requirements and to provide written informed consent and assent\n\n","\n\n * Known co-existing bleeding disorders other than hemophilia A or B\n * Antithrombin (AT) activity <60% at Screening\n * Co-existing thrombophilic disorder\n * Clinically significant liver disease\n * Active HCV infection\n * HIV positive with a CD4 count of <200 cells/Î¼L\n * History of arterial or venous thromboembolism\n * Inadequate renal function\n * History of multiple drug allergies or history of allergic reaction to an oligonucleotide or N-Acetylgalactosamine (GalNAc)\n * History of intolerance to SC injection(s)\n * Any other conditions or comorbidities that would make the patient unsuitable for enrollment or could interfere with participation in or completion of the study, per Investigator judgement",{"$nulls":4},"Actual","2018-01-31","Actual","Anticipated","2019-07-01","Anticipated","2018-06-01","2018-01-25","2018-01-30","2018-08-08","Yes","RNAi therapeutic\nHemophilia A\nHemophilia B\nHemophilia A, Severe\nHemophilia B, Severe\nBlood Coagulation Disorders, Inherited\nBlood Coagulation Disorders\nHematologic Diseases\nCoagulation Protein Disorders\nHemorrhagic Disorders\nGenetic Diseases, Inborn\nGenetic Diseases, X-Linked\nFactor VIII\nFactor IX\nInhibitor\nBypassing agents\nCoagulants\nFitusiran","Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","12 Years",null,"Male",null,"No","Yes\nQualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://www.clinicalstudydatarequest.com/",{"$nulls":3},"Yes","No",{"$nulls":17},"2016-001463-36|ALN-AT3SC-003","EudraCT Number|Alnylam","Annualized bleeding rate (ABR)","9 months",null,"Annualized spontaneous bleeding rate|Annualized joint bleeding rate|Quality of Life (QOL) as measured by Haem-A-QOL Questionnaire score on a scale of 0-100 with higher scores representing greater impairment.","9 months",null,"Contact-US@sanofi.com","Trial Transparency email recommended (Toll free number for US & Canada)","800-633-1610 Ext. 1 then #","Melbourne, Australia, 3004|Phoenix, Arizona, United States, 85016|Orange, California, United States, 92868 Clinical Trial SiteSan Diego, California, United States, 92123|Tampa, Florida, United States, 33607|New Orleans, Louisiana, United States, 70112|Las Vegas, Nevada, United States, 89109|Chapel Hill, North Carolina, United States, 27517|Akron, Ohio, United States, 44308","Arizona|California|Florida|Louisiana|Nevada|North Carolina|Ohio","Australia|United States","Clinical Trial Site",{"$nulls":3},"Clinical Sciences & Operations, MD","2018-08-08","2020-05-25T16:39:47.416","2020-05-26T17:10:42.972","NCT03417102"]
["5ecbf4d311702c1b1b916be2","NCT03417102","2019-05-20","Sanofi","SNY","Recruiting","A Study of Fitusiran (ALN-AT3SC) in Severe Hemophilia A and B Patients With Inhibitors (ATLAS-INH)","Fitusiran",null,"Yes","['Fitusiran']","Unknown",null,"Phase 3",2,54,"Anticipated","2018-02-14","2020-02-10","ABR","Annualized Bleeding Rate",{"$nulls":3},"The purpose of this study is to determine the frequency of bleeding episodes in patients receiving fitusiran as prophylactic treatment of hemophilia compared with patients who are assigned to continue with their regular medication. In addition, the study will assess safety, quality of life, pharmacodynamics (PD), and pharmacokinetics (PK).",null,"ATLAS-INH: A Phase 3 Study to Evaluate the Efficacy and Safety of Fitusiran in Patients With Hemophilia A or B, With Inhibitory Antibodies to Factor VIII or IX","EFC14768","Hemophilia A\nHemophilia B","Hemophilia A|Hemophilia B","Hematologic Diseases","Heme & Lymph Diseases","Experimental|Active Comparator","Fitusiran|On demand bypassing agents",null,"Drug","fitusiran|recombinant Factor VIIa and FEIBA","by subcutaneous (SC) injection|by intravenous (IV) injection",null,"Fitusiran|On demand bypassing agents","\n\n * Males, â‰¥12 years of age\n * Severe hemophilia A or B with inhibitors * (Severity confirmed by a central laboratory where FVIII level is <1% or FIX level is â‰¤2% at Screening; Inhibitors defined as inhibitor titer of â‰¥0.6 BU/mL or as evidenced by medical records)\n   \n   \n * A minimum of 6 bleeding episodes requiring bypassing agent treatment within the last 6 months prior to Screening\n * Willing and able to comply with the study requirements and to provide written informed consent and assent\n\n","\n\n * Known co-existing bleeding disorders other than hemophilia A or B\n * Antithrombin (AT) activity <60% at Screening\n * Co-existing thrombophilic disorder\n * Clinically significant liver disease\n * Active HCV infection\n * HIV positive with a CD4 count of <200 cells/Î¼L\n * History of arterial or venous thromboembolism\n * Inadequate renal function\n * History of multiple drug allergies or history of allergic reaction to an oligonucleotide or N-Acetylgalactosamine (GalNAc)\n * History of intolerance to SC injection(s)\n * Any other conditions or comorbidities that would make the patient unsuitable for enrollment or could interfere with participation in or completion of the study, per Investigator judgement",{"$nulls":4},"Actual","2018-01-31","Actual","Anticipated","2020-08-10","Anticipated","2019-05-01","2018-01-25","2018-01-30","2019-05-16","Yes","RNAi therapeutic\nHemophilia A\nHemophilia B\nHemophilia A, Severe\nHemophilia B, Severe\nBlood Coagulation Disorders, Inherited\nBlood Coagulation Disorders\nHematologic Diseases\nCoagulation Protein Disorders\nHemorrhagic Disorders\nGenetic Diseases, Inborn\nGenetic Diseases, X-Linked\nFactor VIII\nFactor IX\nInhibitor\nBypassing agents\nCoagulants\nFitusiran","Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","12 Years",null,"Male",null,"No","Yes\nQualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://www.clinicalstudydatarequest.com/",{"$nulls":3},"Yes","No",{"$nulls":17},"2016-001463-36|ALN-AT3SC-003","EudraCT Number|Alnylam","Annualized bleeding rate (ABR)","9 months",null,"Annualized spontaneous bleeding rate|Annualized joint bleeding rate|Quality of Life (QOL) as measured by Haem-A-QOL Questionnaire score on a scale of 0-100 with higher scores representing greater impairment.","9 months",null,"Contact-US@sanofi.com","Trial Transparency email recommended (Toll free number for US & Canada)","800-633-1610 Ext. 1 then #","Camperdown, Australia, 2050 Investigational Site Number 6104Clayton, Australia, 3168|Sofia, Bulgaria, 1233|Lyon, France, 69677 Investigational Site Number 3301Rouen, France, 76038|Frankfurt Am Main, Germany, 60590 Investigational Site Number 4906Leipzig, Germany, 4103|Mumbai, India, 400078|Tel Aviv, Israel Korea, Republic Of Investigational Site Number 8202Daejeon, Korea, Republic Of, 35233 Investigational Site Number 8203Seoul, Korea, Republic Of, 3722 Investigational Site Number 8204Seoul, Korea, Republic Of Taiwan Investigational Site Number 8803Changhua, Taiwan, 500 Investigational Site Number 8801Taipei, Taiwan, 110|Akdeniz, Turkey, ?07059 Investigational Site Number 9001Ankara, Turkey, ?06100 Investigational Site Number 9003Izmir, Turkey, 35100|Kyiv, Ukraine, 4112 Investigational Site Number 8003Kyiv, Ukraine, ?01135 Investigational Site Number 8002Lviv, Ukraine, 79044|Phoenix, Arizona, United States, 85016 Investigational Site Number 117Phoenix, Arizona, United States, 85016|Orange, California, United States, 92868 Investigational Site Number 137San Diego, California, United States, 92123|Tampa, Florida, United States, 33607|New Orleans, Louisiana, United States, 70112|Akron, Ohio, United States, 44308","Arizona|California|Florida|Louisiana|Ohio","Australia|Bulgaria|France|Germany|India|Israel|Turkey|Ukraine|United States","Investigational Site Number 6101|Investigational Site Number 5901|Investigational Site Number 3303|Investigational Site Number 4905|Investigational Site Number 9107|Investigational Site Number 9701|Investigational Site Number 9004|Investigational Site Number 8001|Investigational Site Number 0117|Investigational Site Number 0135|Investigational Site Number 0103|Investigational Site Number 0119|Investigational Site Number 110",{"$nulls":3},"Clinical Sciences & Operations, MD","2019-05-16","2020-05-25T16:39:47.431","2020-05-26T17:10:42.972","NCT03417102"]
["5ecbf4d3e2561b1b11905ed1","NCT03417102","2020-02-24","Sanofi","SNY","Recruiting","A Study of Fitusiran (ALN-AT3SC) in Severe Hemophilia A and B Patients With Inhibitors (ATLAS-INH)","Fitusiran",null,"Yes","['Fitusiran']","Unknown",null,"Phase 3",2,54,"Anticipated","2018-02-14","2020-12-09","ABR","Annualized Bleeding Rate",{"$nulls":3},"The purpose of this study is to determine the frequency of bleeding episodes in patients receiving fitusiran as prophylactic treatment of hemophilia compared with patients who are assigned to continue with their regular medication. In addition, the study will assess safety, quality of life, pharmacodynamics (PD), and pharmacokinetics (PK).",null,"ATLAS-INH: A Phase 3 Study to Evaluate the Efficacy and Safety of Fitusiran in Patients With Hemophilia A or B, With Inhibitory Antibodies to Factor VIII or IX","EFC14768","Hemophilia A\nHemophilia B","Hemophilia A|Hemophilia B","Hematologic Diseases","Heme & Lymph Diseases","Experimental|Active Comparator","Fitusiran|On demand bypassing agents",null,"Drug","fitusiran|recombinant Factor VIIa and FEIBA","by subcutaneous (SC) injection|by intravenous (IV) injection",null,"Fitusiran|On demand bypassing agents","\n\n * Males, â‰¥12 years of age\n * Severe hemophilia A or B with inhibitors * (Severity confirmed by a central laboratory where FVIII level is <1% or FIX level is â‰¤2% at Screening; Inhibitors defined as inhibitor titer of â‰¥0.6 BU/mL or as evidenced by medical records)\n   \n   \n * A minimum of 6 bleeding episodes requiring bypassing agent treatment within the last 6 months prior to Screening\n * Willing and able to comply with the study requirements and to provide written informed consent and assent\n\n","\n\n * Known co-existing bleeding disorders other than hemophilia A or B\n * Antithrombin (AT) activity <60% at Screening\n * Co-existing thrombophilic disorder\n * Clinically significant liver disease\n * Active HCV infection\n * HIV positive with a CD4 count of <200 cells/Î¼L\n * History of arterial or venous thromboembolism\n * Inadequate renal function\n * History of multiple drug allergies or history of allergic reaction to an oligonucleotide or N-Acetylgalactosamine (GalNAc)\n * History of intolerance to SC injection(s)\n * Any other conditions or comorbidities that would make the patient unsuitable for enrollment or could interfere with participation in or completion of the study, per Investigator judgement",{"$nulls":4},"Actual","2018-01-31","Actual","Anticipated","2021-06-01","Anticipated","2020-01-01","2018-01-25","2018-01-30","2020-02-21","Yes","RNAi therapeutic\nHemophilia A\nHemophilia B\nHemophilia A, Severe\nHemophilia B, Severe\nBlood Coagulation Disorders, Inherited\nBlood Coagulation Disorders\nHematologic Diseases\nCoagulation Protein Disorders\nHemorrhagic Disorders\nGenetic Diseases, Inborn\nGenetic Diseases, X-Linked\nFactor VIII\nFactor IX\nInhibitor\nBypassing agents\nCoagulants\nFitusiran","Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","12 Years",null,"Male",null,"No","Yes\nQualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://www.clinicalstudydatarequest.com/",{"$nulls":3},"Yes","No",{"$nulls":17},"2016-001463-36|ALN-AT3SC-003","EudraCT Number|Alnylam","Annualized bleeding rate (ABR)","9 months",null,"Annualized spontaneous bleeding rate|Annualized joint bleeding rate|Quality of Life (QOL) as measured by Haem-A-QOL Questionnaire score on a scale of 0-100 with higher scores representing greater impairment.","9 months",null,"Contact-US@sanofi.com","Trial Transparency email recommended (Toll free number for US & Canada)","800-633-1610 Ext. option 6","Camperdown, Australia, 2050 Investigational Site Number 6104Clayton, Australia, 3168|Sofia, Bulgaria, 1233|Montreal, Canada, H1T 2M4|Beijing, China, 100045 Investigational Site Number 8602[Active, Not Recruiting]Guangzhou, China, 510515 Investigational Site Number 8605Hangzhou, China, 310003 Investigational Site Number 8603Shanghai, China, 200025 Investigational Site Number 8601Tianjin, China, 300020|Copenhagen, Denmark, 2100|Lyon, France, 69677 Investigational Site Number 3301Rouen, France, 76038|Frankfurt Am Main, Germany, 60590 Investigational Site Number 4906Leipzig, Germany, 4103|Pecs, Hungary, 7624|Bangalore, India, 560034 Investigational Site Number 9108, India, India Investigational Site Number 9104Jaipur, India, 302017 Investigational Site Number 9106Lucknow, India, 226003 Investigational Site Number 9107Mumbai, India, 400078 Investigational Site Number 9103Pune, India, 411001 Investigational Site Number 9105Vellore, India, 632004|Ramat Gan, Israel|Florence, Italy, 50134 Investigational Site Number 3904Padua, Italy, 35128|Kashihara-Shi, Japan Investigational Site Number 8103Kita Kyushu-Shi, Japan Korea, Republic Of Investigational Site Number 8202Daejeon, Korea, Republic Of, 35233 Investigational Site Number 8203Seoul, Korea, Republic Of, 3722 Investigational Site Number 8204Seoul, Korea, Republic Of|Kota Kinabalu, Malaysia, 88586 Investigational Site Number 6004, Malaysia, Malaysia|Coimbra, Portugal, 3000-076 Investigational Site Number 5103Porto, Portugal, 4099-001 Russian Federation Investigational Site Number 0705Kirov, Russian Federation, 610027 Investigational Site Number 0703Moscow, Russian Federation, 125167 Investigational Site Number 0701St. Petersburg, Russian Federation, 191186|Parktown, South Africa, 2193 Investigational Site Number 2703Polokwane, South Africa, 699 Investigational Site Number 2702Port Elizabeth, South Africa, 6001|Madrid, Spain, 28046 Taiwan Investigational Site Number 8803Changhua, Taiwan, 500 Investigational Site Number 8801[Active, Not Recruiting]Taipei, Taiwan, 110 Investigational Site Number 8804Taiwan, Taiwan Investigational Site Number 8805Taiwan, Taiwan|Adana, Turkey, ?01130 Investigational Site Number 9004Akdeniz, Turkey, ?07059 Investigational Site Number 9001[Active, Not Recruiting]Ankara, Turkey, 06100 Investigational Site Number 9005Istanbul, Turkey, 34093 Investigational Site Number 9003Izmir, Turkey, 35100 Investigational Site Number 9006, Turkey, Turkey|Kyiv, Ukraine, 04060 Investigational Site Number 8003[Active, Not Recruiting]Kyiv, Ukraine, ?01135 Investigational Site Number 8002Lviv, Ukraine, 79044|London, United Kingdom, E1 2Es Investigational Site Number 4401London, United Kingdom, Se1 7Eh|Phoenix, Arizona, United States, 85016|Los Angeles, California, United States, 90027 Investigational Site Number 0135Orange, California, United States, 92868 Investigational Site Number 0137San Diego, California, United States, 92123|Gainesville, Florida, United States, 32610 Investigational Site Number 0115Jacksonville, Florida, United States, 32207 Investigational Site Number 0105Miami, Florida, United States, 33136 Investigational Site Number 0103Tampa, Florida, United States, 33607|[Active, Not Recruiting]New Orleans, Louisiana, United States, 70112|Baltimore, Maryland, United States, 21205|Detroit, Michigan, United States, 48202|Las Vegas, Nevada, United States, 89135|Chapel Hill, North Carolina, United States, 27517|Akron, Ohio, United States, 44308|Philadelphia, Pennsylvania, United States, 19104-5127|Houston, Texas, United States, 77030-1312","Arizona|California|Florida|Louisiana|Maryland|Michigan|Nevada|North Carolina|Ohio|Pennsylvania|Texas","Australia|Bulgaria|Canada|China|Denmark|France|Germany|Hungary|India|Israel|Italy|Japan|Malaysia|Portugal|South Africa|Spain|Turkey|Ukraine|United Kingdom|United States","Investigational Site Number 6101|Investigational Site Number 5901|Investigational Site Number 1102|Investigational Site Number 8604|Investigational Site Number 4501|Investigational Site Number 3303|Investigational Site Number 4905|Investigational Site Number 3601|Investigational Site Number 9102|Investigational Site Number 9701|Investigational Site Number 3901|Investigational Site Number 8110, Japan, Japan| Investigational Site Number 8108|Investigational Site Number 6003|Investigational Site Number 5104|Investigational Site Number 2701|Investigational Site Number 3402|Investigational Site Number 9002|Investigational Site Number 8001|Investigational Site Number 4407|Investigational Site Number 0117|Investigational Site Number 0139|Investigational Site Number 0128|Investigational Site Number 0119|Investigational Site Number 0136|Investigational Site Number 0120|Investigational Site Number 0111|Investigational Site Number 0122|Investigational Site Number 0110|Investigational Site Number 0104|Investigational Site Number 107",{"$nulls":3},"Clinical Sciences & Operations, MD","2020-02-21","2020-05-25T16:39:47.738","2020-05-26T17:10:42.972","NCT03417102"]
["5ecbf4d3feab101b15530a05","NCT03417102","2020-03-23","Sanofi","SNY","Recruiting","A Study of Fitusiran (ALN-AT3SC) in Severe Hemophilia A and B Patients With Inhibitors (ATLAS-INH)","Fitusiran",null,"Yes","['Fitusiran']","Unknown",null,"Phase 3",2,54,"Anticipated","2018-02-14","2020-12-09","ABR","Annualized Bleeding Rate",{"$nulls":3},"The purpose of this study is to determine the frequency of bleeding episodes in patients receiving fitusiran as prophylactic treatment of hemophilia compared with patients who are assigned to continue with their regular medication. In addition, the study will assess safety, quality of life, pharmacodynamics (PD), and pharmacokinetics (PK).",null,"ATLAS-INH: A Phase 3 Study to Evaluate the Efficacy and Safety of Fitusiran in Patients With Hemophilia A or B, With Inhibitory Antibodies to Factor VIII or IX","EFC14768","Hemophilia A\nHemophilia B","Hemophilia A|Hemophilia B","Hematologic Diseases","Heme & Lymph Diseases","Experimental|Active Comparator","Fitusiran|On demand bypassing agents",null,"Drug","fitusiran|recombinant Factor VIIa and FEIBA","by subcutaneous (SC) injection|by intravenous (IV) injection",null,"Fitusiran|On demand bypassing agents","\n\n * Males, â‰¥12 years of age\n * Severe hemophilia A or B with inhibitors * (Severity confirmed by a central laboratory where FVIII level is <1% or FIX level is â‰¤2% at Screening; Inhibitors defined as inhibitor titer of â‰¥0.6 BU/mL or as evidenced by medical records)\n   \n   \n * A minimum of 6 bleeding episodes requiring bypassing agent treatment within the last 6 months prior to Screening\n * Willing and able to comply with the study requirements and to provide written informed consent and assent\n\n","\n\n * Known co-existing bleeding disorders other than hemophilia A or B\n * Antithrombin (AT) activity <60% at Screening\n * Co-existing thrombophilic disorder\n * Clinically significant liver disease\n * Active HCV infection\n * HIV positive with a CD4 count of <200 cells/Î¼L\n * History of arterial or venous thromboembolism\n * Inadequate renal function\n * History of multiple drug allergies or history of allergic reaction to an oligonucleotide or N-Acetylgalactosamine (GalNAc)\n * History of intolerance to SC injection(s)\n * Any other conditions or comorbidities that would make the patient unsuitable for enrollment or could interfere with participation in or completion of the study, per Investigator judgement",{"$nulls":4},"Actual","2018-01-31","Actual","Anticipated","2021-06-01","Anticipated","2020-03-01","2018-01-25","2018-01-30","2020-03-20","Yes","RNAi therapeutic\nHemophilia A\nHemophilia B\nHemophilia A, Severe\nHemophilia B, Severe\nBlood Coagulation Disorders, Inherited\nBlood Coagulation Disorders\nHematologic Diseases\nCoagulation Protein Disorders\nHemorrhagic Disorders\nGenetic Diseases, Inborn\nGenetic Diseases, X-Linked\nFactor VIII\nFactor IX\nInhibitor\nBypassing agents\nCoagulants\nFitusiran","Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","12 Years",null,"Male",null,"No","Yes\nQualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://www.clinicalstudydatarequest.com/",{"$nulls":3},"Yes","No",{"$nulls":17},"2016-001463-36|ALN-AT3SC-003","EudraCT Number|Alnylam","Annualized bleeding rate (ABR)","9 months",null,"Annualized spontaneous bleeding rate|Annualized joint bleeding rate|Quality of Life (QOL) as measured by Haem-A-QOL Questionnaire score on a scale of 0-100 with higher scores representing greater impairment.","9 months",null,"Contact-US@sanofi.com","Trial Transparency email recommended (Toll free number for US & Canada)","800-633-1610 Ext. option 6","Camperdown, Australia, 2050 Investigational Site Number 6104Clayton, Australia, 3168|Sofia, Bulgaria, 1233|Montreal, Canada, H1T 2M4|Beijing, China, 100045 Investigational Site Number 8602[Active, Not Recruiting]Guangzhou, China, 510515 Investigational Site Number 8605Hangzhou, China, 310003 Investigational Site Number 8603Shanghai, China, 200025 Investigational Site Number 8601Tianjin, China, 300020|Copenhagen, Denmark, 2100|Lyon, France, 69677 Investigational Site Number 3301Rouen, France, 76038|Frankfurt Am Main, Germany, 60590 Investigational Site Number 4906Leipzig, Germany, 4103|Pecs, Hungary, 7624|Bangalore, India, 560034 Investigational Site Number 9108, India, India Investigational Site Number 9104Jaipur, India, 302017 Investigational Site Number 9106Lucknow, India, 226003 Investigational Site Number 9107Mumbai, India, 400078 Investigational Site Number 9103Pune, India, 411001 Investigational Site Number 9111Pune, India, 411004 Investigational Site Number 9105Vellore, India, 632004|Ramat Gan, Israel|Florence, Italy, 50134 Investigational Site Number 3904Padua, Italy, 35128|Kashihara-Shi, Japan Investigational Site Number 8103Kita Kyushu-Shi, Japan Korea, Republic Of Investigational Site Number 8202Daejeon, Korea, Republic Of, 35233 Investigational Site Number 8203Seoul, Korea, Republic Of, 3722 Investigational Site Number 8204Seoul, Korea, Republic Of|Kota Kinabalu, Malaysia, 88586 Investigational Site Number 6004, Malaysia, Malaysia|Coimbra, Portugal, 3000-076 Investigational Site Number 5103Porto, Portugal, 4099-001 Russian Federation Investigational Site Number 0705Kirov, Russian Federation, 610027 Investigational Site Number 0703Moscow, Russian Federation, 125167 Investigational Site Number 0701St. Petersburg, Russian Federation, 191186|Parktown, South Africa, 2193 Investigational Site Number 2703[Active, Not Recruiting]Polokwane, South Africa, 699 Investigational Site Number 2702Port Elizabeth, South Africa, 6001|Madrid, Spain, 28046 Taiwan Investigational Site Number 8803Changhua, Taiwan, 500 Investigational Site Number 8801Taipei, Taiwan, 110 Investigational Site Number 8804Taiwan, Taiwan Investigational Site Number 8805[Active, Not Recruiting]Taiwan, Taiwan|[Active, Not Recruiting]Adana, Turkey, ?01130 Investigational Site Number 9004Akdeniz, Turkey, 07059 Investigational Site Number 9001[Active, Not Recruiting]Ankara, Turkey, 06100 Investigational Site Number 9005Istanbul, Turkey, 34093 Investigational Site Number 9003Izmir, Turkey, 35100 Investigational Site Number 9006[Active, Not Recruiting], Turkey, Turkey|Kyiv, Ukraine, 01135 Investigational Site Number 8001Kyiv, Ukraine, 04060 Investigational Site Number 8002Lviv, Ukraine, 79044|London, United Kingdom, E1 2Es Investigational Site Number 4401London, United Kingdom, Se1 7Eh|Phoenix, Arizona, United States, 85016|Los Angeles, California, United States, 90027 Investigational Site Number 0135Orange, California, United States, 92868 Investigational Site Number 0137San Diego, California, United States, 92123|[Active, Not Recruiting]Gainesville, Florida, United States, 32610 Investigational Site Number 0115Jacksonville, Florida, United States, 32207 Investigational Site Number 0105Miami, Florida, United States, 33136 Investigational Site Number 0103Tampa, Florida, United States, 33607|New Orleans, Louisiana, United States, 70112|Baltimore, Maryland, United States, 21205|Detroit, Michigan, United States, 48202|Las Vegas, Nevada, United States, 89135|Chapel Hill, North Carolina, United States, 27517|Akron, Ohio, United States, 44308|Philadelphia, Pennsylvania, United States, 19104-5127","Arizona|California|Florida|Louisiana|Maryland|Michigan|Nevada|North Carolina|Ohio|Pennsylvania","Australia|Bulgaria|Canada|China|Denmark|France|Germany|Hungary|India|Israel|Italy|Japan|Malaysia|Portugal|South Africa|Spain|Turkey|Ukraine|United Kingdom|United States","Investigational Site Number 6101|Investigational Site Number 5901|Investigational Site Number 1102|Investigational Site Number 8604|Investigational Site Number 4501|Investigational Site Number 3303|Investigational Site Number 4905|Investigational Site Number 3601|Investigational Site Number 9102|Investigational Site Number 9701|Investigational Site Number 3901|Investigational Site Number 8110, Japan, Japan| Investigational Site Number 8108|Investigational Site Number 6003|Investigational Site Number 5104|Investigational Site Number 2701|Investigational Site Number 3402|Investigational Site Number 9002|Investigational Site Number 8003|Investigational Site Number 4407|Investigational Site Number 0117|Investigational Site Number 0139|Investigational Site Number 0128|Investigational Site Number 0119|Investigational Site Number 0136|Investigational Site Number 0120|Investigational Site Number 0111|Investigational Site Number 0122|Investigational Site Number 0110|Investigational Site Number 0104",{"$nulls":3},"Clinical Sciences & Operations, MD","2020-03-20","2020-05-25T16:39:47.648","2020-05-26T17:10:42.972","NCT03417102"]
["5ecbf4d4e2561b1b11905ed3","NCT03417245","2018-01-31","Alnylam","ALNY","Recruiting","A Study of Fitusiran (ALN-AT3SC) in Severe Hemophilia A and B Patients Without Inhibitors","Fitusiran",null,"Yes","['Fitusiran']","Unknown",null,"Phase 3",2,120,"Anticipated","2018-01-08","2019-11-01","ABR","Annualized Bleeding Rate","Sanofi","Industry","SNY","The purpose of this study is to determine the frequency of bleeding episodes in patients receiving fitusiran as prophylactic treatment of hemophilia compared with patients who are assigned to continue with their regular medication. In addition, the study will assess safety, quality of life, pharmacodynamics (PD), and pharmacokinetics (PK).",null,"ATLAS-A/B: A Phase 3 Study to Evaluate the Efficacy and Safety of Fitusiran in Patients With Hemophilia A or B, Without Inhibitory Antibodies to Factor VIII or IX","ALN-AT3SC-004","Hemophilia A\nHemophilia B","Hemophilia A|Hemophilia B","Hematologic Diseases","Heme & Lymph Diseases","Experimental|Active Comparator","fitusiran|On Demand factor VIII or IX",null,"Drug","fitusiran|factor VIII or factor IX","by subcutaneous (SC) injection|by intravenous (IV) injection",null,"fitusiran|On Demand factor VIII or IX","\n\n * Males, â‰¥12 years of age\n * Severe hemophilia A or B without inhibitors * (Severity confirmed by a central laboratory where FVIII level is <1% or FIX level is â‰¤2% at Screening; Inhibitors defined as Nijmegen modified Bethesda assay inhibitor titer of <0.6 BU/mL at Screening)\n   \n   \n * A minimum of 6 bleeding episodes requiring factor concentrate treatment within the last 6 months prior to Screening.\n * Willing and able to comply with the study requirements and to provide written informed consent and assent\n\n","\n\n * Known co-existing bleeding disorders other than hemophilia A or B\n * Antithrombin (AT) activity <60% at Screening\n * Co-existing thrombophilic disorder\n * Clinically significant liver disease\n * Active HCV infection\n * HIV positive with a CD4 count of <200 cells/Î¼L\n * History of arterial or venous thromboembolism\n * Inadequate renal function\n * History of multiple drug allergies or history of allergic reaction to an oligonucleotide or N-Acetylgalactosamine (GalNAc)\n * History of intolerance to SC injection(s)\n * Any other conditions or comorbidities that would make the patient unsuitable for enrollment or could interfere with participation in or completion of the study, per Investigator judgment",{"$nulls":4},"Actual","2018-01-31","Actual","Anticipated","2019-12-01","Anticipated","2018-01-01","2018-01-25","2018-01-30","2018-01-30","Yes","RNAi therapeutic\nHemophilia A\nHemophilia B\nHemophilia A, Severe\nHemophilia B, Severe\nBlood Coagulation Disorders, Inherited\nBlood Coagulation Disorders\nHematologic Diseases\nCoagulation Protein Disorders\nHemorrhagic Disorders\nGenetic Diseases, Inborn\nGenetic Diseases, X-Linked\nFactor VIII\nFactor IX\nCoagulants\nFitusiran","Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","12 Years",null,"Male",null,"No",{"$nulls":4},"Yes","No",{"$nulls":19},"Annualized bleeding rate (ABR)","9 months",null,"Annualized spontaneous bleeding rate|Annualized joint bleeding rate|Haem-A-QOL Questionnaire","9 months",null,"clinicaltrials@alnylam.com","Alnylam Clinical Trials","866-330-0326","Chapel Hill, North Carolina, United States, 27517","North Carolina","United States","Clinical Trial Site",{"$nulls":3},"Kate Madigan, MD","2018-01-30","2020-05-25T16:39:48.575","2020-05-26T17:10:42.972","NCT03417245"]
["5ecbf4d4feab101b15530a07","NCT03417245","2018-02-08","Alnylam","ALNY","Recruiting","A Study of Fitusiran (ALN-AT3SC) in Severe Hemophilia A and B Patients Without Inhibitors","Fitusiran",null,"Yes","['Fitusiran']","Unknown",null,"Phase 3",2,120,"Anticipated","2018-01-08","2019-11-01","ABR","Annualized Bleeding Rate","Sanofi","Industry","SNY","The purpose of this study is to determine the frequency of bleeding episodes in patients receiving fitusiran as prophylactic treatment of hemophilia compared with patients who are assigned to continue with their regular medication. In addition, the study will assess safety, quality of life, pharmacodynamics (PD), and pharmacokinetics (PK).",null,"ATLAS-A/B: A Phase 3 Study to Evaluate the Efficacy and Safety of Fitusiran in Patients With Hemophilia A or B, Without Inhibitory Antibodies to Factor VIII or IX","ALN-AT3SC-004","Hemophilia A\nHemophilia B","Hemophilia A|Hemophilia B","Hematologic Diseases","Heme & Lymph Diseases","Experimental|Active Comparator","fitusiran|On Demand factor VIII or IX",null,"Drug","fitusiran|factor VIII or factor IX","by subcutaneous (SC) injection|by intravenous (IV) injection",null,"fitusiran|On Demand factor VIII or IX","\n\n * Males, â‰¥12 years of age\n * Severe hemophilia A or B without inhibitors * (Severity confirmed by a central laboratory where FVIII level is <1% or FIX level is â‰¤2% at Screening; Inhibitors defined as Nijmegen modified Bethesda assay inhibitor titer of <0.6 BU/mL at Screening)\n   \n   \n * A minimum of 6 bleeding episodes requiring factor concentrate treatment within the last 6 months prior to Screening.\n * Willing and able to comply with the study requirements and to provide written informed consent and assent\n\n","\n\n * Known co-existing bleeding disorders other than hemophilia A or B\n * Antithrombin (AT) activity <60% at Screening\n * Co-existing thrombophilic disorder\n * Clinically significant liver disease\n * Active HCV infection\n * HIV positive with a CD4 count of <200 cells/Î¼L\n * History of arterial or venous thromboembolism\n * Inadequate renal function\n * History of multiple drug allergies or history of allergic reaction to an oligonucleotide or N-Acetylgalactosamine (GalNAc)\n * History of intolerance to SC injection(s)\n * Any other conditions or comorbidities that would make the patient unsuitable for enrollment or could interfere with participation in or completion of the study, per Investigator judgment",{"$nulls":4},"Actual","2018-01-31","Actual","Anticipated","2019-12-01","Anticipated","2018-02-01","2018-01-25","2018-01-30","2018-02-06","Yes","RNAi therapeutic\nHemophilia A\nHemophilia B\nHemophilia A, Severe\nHemophilia B, Severe\nBlood Coagulation Disorders, Inherited\nBlood Coagulation Disorders\nHematologic Diseases\nCoagulation Protein Disorders\nHemorrhagic Disorders\nGenetic Diseases, Inborn\nGenetic Diseases, X-Linked\nFactor VIII\nFactor IX\nCoagulants\nFitusiran","Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","12 Years",null,"Male",null,"No",{"$nulls":4},"Yes","No",{"$nulls":19},"Annualized bleeding rate (ABR)","9 months",null,"Annualized spontaneous bleeding rate|Annualized joint bleeding rate|Quality of Life (QOL) as measured by Haem-A-QOL Questionnaire score on a scale of 0-100 with higher scores representing greater impairment","9 months",null,"clinicaltrials@alnylam.com","Alnylam Clinical Trials","866-330-0326","Chapel Hill, North Carolina, United States, 27517","North Carolina","United States","Clinical Trial Site",{"$nulls":3},"Kate Madigan, MD","2018-02-06","2020-05-25T16:39:48.575","2020-05-26T17:10:42.972","NCT03417245"]
["5ecbf4d4feab101b15530a08","NCT03417245","2019-01-23","Sanofi","SNY","Recruiting","A Study of Fitusiran (ALN-AT3SC) in Severe Hemophilia A and B Patients Without Inhibitors","Fitusiran",null,"Yes","['Fitusiran']","Unknown",null,"Phase 3",2,120,"Anticipated","2018-07-02","2020-04-09","ABR","Annualized Bleeding Rate",{"$nulls":3},"The purpose of this study is to determine the frequency of bleeding episodes in patients receiving fitusiran as prophylactic treatment of hemophilia compared with patients who are assigned to continue with their regular medication. In addition, the study will assess safety, quality of life, pharmacodynamics (PD), and pharmacokinetics (PK).",null,"ATLAS-A/B: A Phase 3 Study to Evaluate the Efficacy and Safety of Fitusiran in Patients With Hemophilia A or B, Without Inhibitory Antibodies to Factor VIII or IX","EFC14769","Hemophilia A\nHemophilia B","Hemophilia A|Hemophilia B","Hematologic Diseases","Heme & Lymph Diseases","Experimental|Active Comparator","fitusiran|On Demand factor VIII or IX",null,"Drug","fitusiran|factor VIII or factor IX","by subcutaneous (SC) injection|by intravenous (IV) injection",null,"fitusiran|On Demand factor VIII or IX","\n\n * Males, â‰¥12 years of age\n * Severe hemophilia A or B without inhibitors * (Severity confirmed by a central laboratory where FVIII level is <1% or FIX level is â‰¤2% at Screening; Inhibitors defined as Nijmegen modified Bethesda assay inhibitor titer of <0.6 BU/mL at Screening)\n   \n   \n * A minimum of 6 bleeding episodes requiring factor concentrate treatment within the last 6 months prior to Screening.\n * Willing and able to comply with the study requirements and to provide written informed consent and assent\n\n","\n\n * Known co-existing bleeding disorders other than hemophilia A or B\n * Antithrombin (AT) activity <60% at Screening\n * Co-existing thrombophilic disorder\n * Clinically significant liver disease\n * Active HCV infection\n * HIV positive with a CD4 count of <200 cells/Î¼L\n * History of arterial or venous thromboembolism\n * Inadequate renal function\n * History of multiple drug allergies or history of allergic reaction to an oligonucleotide or N-Acetylgalactosamine (GalNAc)\n * History of intolerance to SC injection(s)\n * Any other conditions or comorbidities that would make the patient unsuitable for enrollment or could interfere with participation in or completion of the study, per Investigator judgment",{"$nulls":4},"Actual","2018-01-31","Actual","Anticipated","2020-10-09","Anticipated","2018-06-01","2018-01-25","2018-01-30","2019-01-21","Yes","RNAi therapeutic\nHemophilia A\nHemophilia B\nHemophilia A, Severe\nHemophilia B, Severe\nBlood Coagulation Disorders, Inherited\nBlood Coagulation Disorders\nHematologic Diseases\nCoagulation Protein Disorders\nHemorrhagic Disorders\nGenetic Diseases, Inborn\nGenetic Diseases, X-Linked\nFactor VIII\nFactor IX\nCoagulants\nFitusiran","Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","12 Years",null,"Male",null,"No","Yes\nQualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://www.clinicalstudydatarequest.com/",{"$nulls":3},"Yes","No",{"$nulls":17},"ALN-AT3SC-004|2016-001464-11","Alnylam|EudraCT Number","Annualized bleeding rate (ABR)","9 months",null,"Annualized spontaneous bleeding rate|Annualized joint bleeding rate|Quality of Life (QOL) as measured by Haem-A-QOL Questionnaire score on a scale of 0-100 with higher scores representing greater impairment","9 months",null,"Contact-US@sanofi.com","Trial Transparency email recommended (Toll free number for US & Canada)","800-633-1610 Ext. 1 then #","Melbourne, Australia, 3004|Phoenix, Arizona, United States, 85016|Orange, California, United States, 92868 Clinical Trial SiteSan Diego, California, United States, 92123|Tampa, Florida, United States, 33607|Boston, Massachusetts, United States, 02114|Ann Arbor, Michigan, United States, 48109|Las Vegas, Nevada, United States, 89109|Chapel Hill, North Carolina, United States, 27517|Akron, Ohio, United States, 44308 Clinical Trial SiteCleveland, Ohio, United States, 44106","Arizona|California|Florida|Massachusetts|Michigan|Nevada|North Carolina|Ohio","Australia|United States","Clinical Trial Site",{"$nulls":3},"Clinical Sciences & Operations, MD","2019-01-21","2020-05-25T16:39:48.804","2020-05-26T17:10:42.972","NCT03417245"]
["5ecbf4d411702c1b1b916be6","NCT03417245","2019-05-20","Sanofi","SNY","Recruiting","A Study of Fitusiran (ALN-AT3SC) in Severe Hemophilia A and B Patients Without Inhibitors","Fitusiran",null,"Yes","['Fitusiran']","Unknown",null,"Phase 3",2,120,"Anticipated","2018-06-04","2020-04-09","ABR","Annualized Bleeding Rate",{"$nulls":3},"The purpose of this study is to determine the frequency of bleeding episodes in patients receiving fitusiran as prophylactic treatment of hemophilia compared with patients who are assigned to continue with their regular medication. In addition, the study will assess safety, quality of life, pharmacodynamics (PD), and pharmacokinetics (PK).",null,"ATLAS-A/B: A Phase 3 Study to Evaluate the Efficacy and Safety of Fitusiran in Patients With Hemophilia A or B, Without Inhibitory Antibodies to Factor VIII or IX","EFC14769","Hemophilia A\nHemophilia B","Hemophilia A|Hemophilia B","Hematologic Diseases","Heme & Lymph Diseases","Experimental|Active Comparator","fitusiran|On Demand factor VIII or IX",null,"Drug","fitusiran|factor VIII or factor IX","by subcutaneous (SC) injection|by intravenous (IV) injection",null,"fitusiran|On Demand factor VIII or IX","\n\n * Males, â‰¥12 years of age\n * Severe hemophilia A or B without inhibitors * (Severity confirmed by a central laboratory where FVIII level is <1% or FIX level is â‰¤2% at Screening; Inhibitors defined as Nijmegen modified Bethesda assay inhibitor titer of <0.6 BU/mL at Screening)\n   \n   \n * A minimum of 6 bleeding episodes requiring factor concentrate treatment within the last 6 months prior to Screening.\n * Willing and able to comply with the study requirements and to provide written informed consent and assent\n\n","\n\n * Known co-existing bleeding disorders other than hemophilia A or B\n * Antithrombin (AT) activity <60% at Screening\n * Co-existing thrombophilic disorder\n * Clinically significant liver disease\n * Active HCV infection\n * HIV positive with a CD4 count of <200 cells/Î¼L\n * History of arterial or venous thromboembolism\n * Inadequate renal function\n * History of multiple drug allergies or history of allergic reaction to an oligonucleotide or N-Acetylgalactosamine (GalNAc)\n * History of intolerance to SC injection(s)\n * Any other conditions or comorbidities that would make the patient unsuitable for enrollment or could interfere with participation in or completion of the study, per Investigator judgment",{"$nulls":4},"Actual","2018-01-31","Actual","Anticipated","2020-10-09","Anticipated","2019-05-01","2018-01-25","2018-01-30","2019-05-16","Yes","RNAi therapeutic\nHemophilia A\nHemophilia B\nHemophilia A, Severe\nHemophilia B, Severe\nBlood Coagulation Disorders, Inherited\nBlood Coagulation Disorders\nHematologic Diseases\nCoagulation Protein Disorders\nHemorrhagic Disorders\nGenetic Diseases, Inborn\nGenetic Diseases, X-Linked\nFactor VIII\nFactor IX\nCoagulants\nFitusiran","Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","12 Years",null,"Male",null,"No","Yes\nQualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://www.clinicalstudydatarequest.com/",{"$nulls":3},"Yes","No",{"$nulls":17},"ALN-AT3SC-004|2016-001464-11","Alnylam|EudraCT Number","Annualized bleeding rate (ABR)","9 months",null,"Annualized spontaneous bleeding rate|Annualized joint bleeding rate|Quality of Life (QOL) as measured by Haem-A-QOL Questionnaire score on a scale of 0-100 with higher scores representing greater impairment","9 months",null,"Contact-US@sanofi.com","Trial Transparency email recommended (Toll free number for US & Canada)","800-633-1610 Ext. 1 then #","Camperdown, Australia, 2050 Investigational Site Number 6104Clayton, Australia, 3168 Investigational Site Number 6103Murdoch, Australia, 6961|Sofia, Bulgaria, 1233|Copenhagen, Denmark, 2100|Lyon, France Investigational Site Number 3301Rouen, France, 76038|Berlin, Germany, 10249 Investigational Site Number 4905Frankfurt Am Main, Germany, 60590 Investigational Site Number 4906Leipzig, Germany, 4103|Budapest, Hungary|Jaipur, India, 302017 Investigational Site Number 9106Lucknow, India, 226003 Investigational Site Number 9103Pune, India, 411001 Investigational Site Number 9105Vellore, India, 632004|Ramat-Gan, Israel, 52621 Korea, Republic Of Investigational Site Number 8202Daejeon, Korea, Republic Of, 35233|Johor Bahru, Malaysia, 80000 Investigational Site Number 6003Kota Kinabalu, Malaysia, 88586|Coimbra, Portugal, 3000-076 Investigational Site Number 5103Porto, Portugal, 4099-001 Russian Federation Investigational Site Number 705Kirov, Russian Federation, 610027 Investigational Site Number 703Moscow, Russian Federation, 125167 Investigational Site Number 701St. Petersburg, Russian Federation, 191186 Taiwan Investigational Site Number 8803Changhua, Taiwan, 500 Investigational Site Number 8801Taipei, Taiwan, 110|Izmir, Turkey, 35100|Kyiv, Ukraine, 4112 Investigational Site Number 8003Kyiv, Ukraine, ?01135 Investigational Site Number 8002Lviv, Ukraine, 79044|Phoenix, Arizona, United States, 85016|Orange, California, United States, 92868 Investigational Site Number 137San Diego, California, United States, 92123|Miami, Florida, United States, 33136 Investigational Site Number 103Tampa, Florida, United States, 33607|Baltimore, Maryland, United States, 21205|Boston, Massachusetts, United States, 02114|Ann Arbor, Michigan, United States, 48109|Las Vegas, Nevada, United States, 89135|Chapel Hill, North Carolina, United States, 27517|Akron, Ohio, United States, 44308 Investigational Site Number 131Cleveland, Ohio, United States, 44106|Philadelphia, Pennsylvania, United States, 19104-5127|Houston, Texas, United States, 77030-1312","Arizona|California|Florida|Maryland|Massachusetts|Michigan|Nevada|North Carolina|Ohio|Pennsylvania|Texas","Australia|Bulgaria|Denmark|France|Germany|Hungary|India|Israel|Malaysia|Portugal|Turkey|Ukraine|United States","Investigational Site Number 6101|Investigational Site Number 5901|Investigational Site Number 4501|Investigational Site Number 3303|Investigational Site Number 4904|Investigational Site Number 3602|Investigational Site Number 9104|Investigational Site Number 9701|Investigational Site Number 6002|Investigational Site Number 5104|Investigational Site Number 9003|Investigational Site Number 8001|Investigational Site Number 117|Investigational Site Number 135|Investigational Site Number 105|Investigational Site Number 136|Investigational Site Number 121|Investigational Site Number 125|Investigational Site Number 111|Investigational Site Number 122|Investigational Site Number 110|Investigational Site Number 104|Investigational Site Number 107",{"$nulls":3},"Clinical Sciences & Operations, MD","2019-05-16","2020-05-25T16:39:48.985","2020-05-26T17:10:42.972","NCT03417245"]
["5ecbf4d511702c1b1b916be7","NCT03417245","2020-01-30","Sanofi","SNY","Recruiting","A Study of Fitusiran (ALN-AT3SC) in Severe Hemophilia A and B Patients Without Inhibitors","Fitusiran",null,"Yes","['Fitusiran']","Unknown",null,"Phase 3",2,120,"Anticipated","2018-03-01","2020-04-09","ABR","Annualized Bleeding Rate",{"$nulls":3},"The purpose of this study is to determine the frequency of bleeding episodes in patients receiving fitusiran as prophylactic treatment of hemophilia compared with patients who are assigned to continue with their regular medication. In addition, the study will assess safety, quality of life, pharmacodynamics (PD), and pharmacokinetics (PK).",null,"ATLAS-A/B: A Phase 3 Study to Evaluate the Efficacy and Safety of Fitusiran in Patients With Hemophilia A or B, Without Inhibitory Antibodies to Factor VIII or IX","EFC14769","Hemophilia A\nHemophilia B","Hemophilia A|Hemophilia B","Hematologic Diseases","Heme & Lymph Diseases","Experimental|Active Comparator","fitusiran|On Demand factor VIII or IX",null,"Drug","fitusiran|factor VIII or factor IX","by subcutaneous (SC) injection|by intravenous (IV) injection",null,"fitusiran|On Demand factor VIII or IX","\n\n * Males, â‰¥12 years of age\n * Severe hemophilia A or B without inhibitors * (Severity confirmed by a central laboratory where FVIII level is <1% or FIX level is â‰¤2% at Screening; Inhibitors defined as Nijmegen modified Bethesda assay inhibitor titer of <0.6 BU/mL at Screening)\n   \n   \n * A minimum of 6 bleeding episodes requiring factor concentrate treatment within the last 6 months prior to Screening.\n * Willing and able to comply with the study requirements and to provide written informed consent and assent\n\n","\n\n * Known co-existing bleeding disorders other than hemophilia A or B\n * Antithrombin (AT) activity <60% at Screening\n * Co-existing thrombophilic disorder\n * Clinically significant liver disease\n * Active HCV infection\n * HIV positive with a CD4 count of <200 cells/Î¼L\n * History of arterial or venous thromboembolism\n * Inadequate renal function\n * History of multiple drug allergies or history of allergic reaction to an oligonucleotide or N-Acetylgalactosamine (GalNAc)\n * History of intolerance to SC injection(s)\n * Any other conditions or comorbidities that would make the patient unsuitable for enrollment or could interfere with participation in or completion of the study, per Investigator judgment",{"$nulls":4},"Actual","2018-01-31","Actual","Anticipated","2021-10-01","Anticipated","2020-01-01","2018-01-25","2018-01-30","2020-01-29","Yes","RNAi therapeutic\nHemophilia A\nHemophilia B\nHemophilia A, Severe\nHemophilia B, Severe\nBlood Coagulation Disorders, Inherited\nBlood Coagulation Disorders\nHematologic Diseases\nCoagulation Protein Disorders\nHemorrhagic Disorders\nGenetic Diseases, Inborn\nGenetic Diseases, X-Linked\nFactor VIII\nFactor IX\nCoagulants\nFitusiran","Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","12 Years",null,"Male",null,"No","Yes\nQualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://www.clinicalstudydatarequest.com/",{"$nulls":3},"Yes","No",{"$nulls":17},"ALN-AT3SC-004|2016-001464-11","Alnylam|EudraCT Number","Annualized bleeding rate (ABR)","9 months",null,"Annualized spontaneous bleeding rate|Annualized joint bleeding rate|Quality of Life (QOL) as measured by Haem-A-QOL Questionnaire score on a scale of 0-100 with higher scores representing greater impairment","9 months",null,"Contact-US@sanofi.com","Trial Transparency email recommended (Toll free number for US & Canada)","800-633-1610 Ext. 1 then #","Camperdown, Australia, 2050 Investigational Site Number 6104Clayton, Australia, 3168 Investigational Site Number 6103Murdoch, Australia, 6961|Sofia, Bulgaria, 1233|Copenhagen, Denmark, 2100|Lyon, France Investigational Site Number 3301Rouen, France, 76038|Berlin, Germany, 10249 Investigational Site Number 4905Frankfurt Am Main, Germany, 60590 Investigational Site Number 4906Leipzig, Germany, 4103|Budapest, Hungary|Jaipur, India, 302017 Investigational Site Number 9106Lucknow, India, 226003 Investigational Site Number 9103Pune, India, 411001 Investigational Site Number 9105Vellore, India, 632004|Ramat-Gan, Israel, 52621|Padua, Italy Korea, Republic Of Investigational Site Number 8202Daejeon, Korea, Republic Of, 35233|Johor Bahru, Malaysia, 80000 Investigational Site Number 6003Kota Kinabalu, Malaysia, 88586|Coimbra, Portugal, 3000-076 Investigational Site Number 5103Porto, Portugal, 4099-001 Russian Federation Investigational Site Number 705Kirov, Russian Federation, 610027 Investigational Site Number 703Moscow, Russian Federation, 125167 Investigational Site Number 701St. Petersburg, Russian Federation, 191186 Taiwan Investigational Site Number 8803Changhua, Taiwan, 500 Investigational Site Number 8801Taipei, Taiwan, 110|Izmir, Turkey, 35100|Kyiv, Ukraine, 4112 Investigational Site Number 8003Kyiv, Ukraine, ?01135 Investigational Site Number 8002Lviv, Ukraine, 79044|Phoenix, Arizona, United States, 85016|Orange, California, United States, 92868 Investigational Site Number 137San Diego, California, United States, 92123|Miami, Florida, United States, 33136 Investigational Site Number 103Tampa, Florida, United States, 33607|Baltimore, Maryland, United States, 21205|Boston, Massachusetts, United States, 02114|Ann Arbor, Michigan, United States, 48109|Las Vegas, Nevada, United States, 89135|Chapel Hill, North Carolina, United States, 27517|Akron, Ohio, United States, 44308 Investigational Site Number 131Cleveland, Ohio, United States, 44106|Philadelphia, Pennsylvania, United States, 19104-5127|Houston, Texas, United States, 77030-1312","Arizona|California|Florida|Maryland|Massachusetts|Michigan|Nevada|North Carolina|Ohio|Pennsylvania|Texas","Australia|Bulgaria|Denmark|France|Germany|Hungary|India|Israel|Italy|Malaysia|Portugal|Turkey|Ukraine|United States","Investigational Site Number 6101|Investigational Site Number 5901|Investigational Site Number 4501|Investigational Site Number 3303|Investigational Site Number 4904|Investigational Site Number 3602|Investigational Site Number 9104|Investigational Site Number 9701|Investigational Site Number 3904|Investigational Site Number 6002|Investigational Site Number 5104|Investigational Site Number 9003|Investigational Site Number 8001|Investigational Site Number 117|Investigational Site Number 135|Investigational Site Number 105|Investigational Site Number 136|Investigational Site Number 121|Investigational Site Number 125|Investigational Site Number 111|Investigational Site Number 122|Investigational Site Number 110|Investigational Site Number 104|Investigational Site Number 107",{"$nulls":3},"Clinical Sciences & Operations, MD","2020-01-29","2020-05-25T16:39:49.162","2020-05-26T17:10:42.972","NCT03417245"]
["5ecbf4d5feab101b15530a09","NCT03417245","2020-02-25","Sanofi","SNY","Recruiting","A Study of Fitusiran (ALN-AT3SC) in Severe Hemophilia A and B Patients Without Inhibitors","Fitusiran",null,"Yes","['Fitusiran']","Unknown",null,"Phase 3",2,120,"Anticipated","2018-03-01","2020-04-09","ABR","Annualized Bleeding Rate",{"$nulls":3},"The purpose of this study is to determine the frequency of bleeding episodes in patients receiving fitusiran as prophylactic treatment of hemophilia compared with patients who are assigned to continue with their regular medication. In addition, the study will assess safety, quality of life, pharmacodynamics (PD), and pharmacokinetics (PK).",null,"ATLAS-A/B: A Phase 3 Study to Evaluate the Efficacy and Safety of Fitusiran in Patients With Hemophilia A or B, Without Inhibitory Antibodies to Factor VIII or IX","EFC14769","Hemophilia A\nHemophilia B","Hemophilia A|Hemophilia B","Hematologic Diseases","Heme & Lymph Diseases","Experimental|Active Comparator","fitusiran|On Demand factor VIII or IX",null,"Drug","fitusiran|factor VIII or factor IX","by subcutaneous (SC) injection|by intravenous (IV) injection",null,"fitusiran|On Demand factor VIII or IX","\n\n * Males, â‰¥12 years of age\n * Severe hemophilia A or B without inhibitors * (Severity confirmed by a central laboratory where FVIII level is <1% or FIX level is â‰¤2% at Screening; Inhibitors defined as Nijmegen modified Bethesda assay inhibitor titer of <0.6 BU/mL at Screening)\n   \n   \n * A minimum of 6 bleeding episodes requiring factor concentrate treatment within the last 6 months prior to Screening.\n * Willing and able to comply with the study requirements and to provide written informed consent and assent\n\n","\n\n * Known co-existing bleeding disorders other than hemophilia A or B\n * Antithrombin (AT) activity <60% at Screening\n * Co-existing thrombophilic disorder\n * Clinically significant liver disease\n * Active HCV infection\n * HIV positive with a CD4 count of <200 cells/Î¼L\n * History of arterial or venous thromboembolism\n * Inadequate renal function\n * History of multiple drug allergies or history of allergic reaction to an oligonucleotide or N-Acetylgalactosamine (GalNAc)\n * History of intolerance to SC injection(s)\n * Any other conditions or comorbidities that would make the patient unsuitable for enrollment or could interfere with participation in or completion of the study, per Investigator judgment",{"$nulls":4},"Actual","2018-01-31","Actual","Anticipated","2021-10-01","Anticipated","2020-02-01","2018-01-25","2018-01-30","2020-02-24","Yes","RNAi therapeutic\nHemophilia A\nHemophilia B\nHemophilia A, Severe\nHemophilia B, Severe\nBlood Coagulation Disorders, Inherited\nBlood Coagulation Disorders\nHematologic Diseases\nCoagulation Protein Disorders\nHemorrhagic Disorders\nGenetic Diseases, Inborn\nGenetic Diseases, X-Linked\nFactor VIII\nFactor IX\nCoagulants\nFitusiran","Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","12 Years",null,"Male",null,"No","Yes\nQualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://www.clinicalstudydatarequest.com/",{"$nulls":3},"Yes","No",{"$nulls":17},"ALN-AT3SC-004|2016-001464-11","Alnylam|EudraCT Number","Annualized bleeding rate (ABR)","9 months",null,"Annualized spontaneous bleeding rate|Annualized joint bleeding rate|Quality of Life (QOL) as measured by Haem-A-QOL Questionnaire score on a scale of 0-100 with higher scores representing greater impairment","9 months",null,"Contact-US@sanofi.com","Trial Transparency email recommended (Toll free number for US & Canada)","800-633-1610 Ext. 1 then #","Camperdown, Australia, 2050 Investigational Site Number 6103Murdoch, Australia, 6961 Investigational Site Number 6104Prahran, Australia, 3181|Sofia, Bulgaria, 1233|Beijing, China, 100045 Investigational Site Number 8602Guangzhou, China, 510515 Investigational Site Number 8605Hangzhou, China, 89147 Investigational Site Number 8603Shanghai, China, 200025 Investigational Site Number 8601Tianjin, China, 300020|Copenhagen, Denmark, 2100|Lyon, France, 69677 Investigational Site Number 3305Paris, France, 75015 Investigational Site Number 3301Rouen, France, 76038|Berlin, Germany, 10249 Investigational Site Number 4903Duisburg, Germany, 47051 Investigational Site Number 4905Frankfurt Am Main, Germany, 60590 Investigational Site Number 4906Leipzig, Germany, 4103|Budapest, Hungary, 1134|Bangalore, India, 560034 Investigational Site Number 9104Jaipur, India, 302017 Investigational Site Number 9106Lucknow, India, 226003 Investigational Site Number 9109Mumbai, India, 400012 Investigational Site Number 9108Mumbai, India, 400022 Investigational Site Number 9107Mumbai, India, 400078 Investigational Site Number 9111Mumbai, India Investigational Site Number 9103Pune, India, 411001 Investigational Site Number 9105Vellore, India, 632004|Ramat-Gan, Israel, 52621|Florence, Italy, 50134 Investigational Site Number 3904Padova, Italy, 35128|Isehara, Japan Investigational Site Number 8104Saitama, Japan Korea, Republic Of Investigational Site Number 8201Busan, Korea, Republic Of, 602-739 Investigational Site Number 8202Daejeon, Korea, Republic Of, 35233 Investigational Site Number 8204Seoul, Korea, Republic Of, 3722|Ampang, Malaysia, 68000 Investigational Site Number 6002Johor Bahru, Malaysia, 80100 Investigational Site Number 6003Kota Kinabalu, Malaysia, 88586|Coimbra, Portugal, 3000-076 Investigational Site Number 5103Porto, Portugal, 4099-001 Russian Federation Investigational Site Number 705Kirov, Russian Federation, 610027 Investigational Site Number 704Krasnoyarsk, Russian Federation, 660022 Investigational Site Number 703Moscow, Russian Federation, 125167 Investigational Site Number 701St. Petersburg, Russian Federation, 191186|Parktown, South Africa, 2193 Investigational Site Number 2703Polokwane, South Africa, 699 Investigational Site Number 2702Port Elizabeth, South Africa, 6001|Madrid, Spain, 28046 Taiwan Investigational Site Number 8803Changhua, Taiwan, 500 Investigational Site Number 8807Taichung, Taiwan, 40447 Investigational Site Number 8805Taichung, Taiwan, 40705 Investigational Site Number 8804Taipei, Taiwan, 100 Investigational Site Number 8801Taipei, Taiwan, 110 Investigational Site Number 8806Taipei, Taiwan, 112 Investigational Site Number 8808Taoyuan, Taiwan, 33305|Adana, Turkey, ?01130 Investigational Site Number 9004Antalya, Turkey, 07059 Investigational Site Number 9008Gaziantep, Turkey, 27100 Investigational Site Number 9005Istanbul, Turkey, 34093 Investigational Site Number 9003Izmir, Turkey, Tr-35100 Investigational Site Number 9009Kayseri, Turkey, 38039 Investigational Site Number 9006Samsun, Turkey, 55200|Kyiv, Ukraine, 04060 Investigational Site Number 8003Kyiv, Ukraine, ?01135 Investigational Site Number 8002Lviv, Ukraine, 79044 Investigational Site Number 8005Mykolaiv, Ukraine, 54058|Glasgow, United Kingdom, G4 0Sf Investigational Site Number 4407London, United Kingdom, E1 2Es Investigational Site Number 4403London, United Kingdom, Nw3 2Qg Investigational Site Number 4401London, United Kingdom, Se1 9Rt|Phoenix, Arizona, United States, 85016|Little Rock, Arkansas, United States, 72202|Loma Linda, California, United States, 92354 Investigational Site Number 135Orange, California, United States, 92868 Investigational Site Number 137San Diego, California, United States, 92123|Gainesville, Florida, United States, 32610 Investigational Site Number 105Miami, Florida, United States, 33101 Investigational Site Number 103Tampa, Florida, United States, 33607|Chicago, Illinois, United States, 60612-3833|New Orleans, Louisiana, United States, 70112|Baltimore, Maryland, United States, 21205|Boston, Massachusetts, United States, 02114 Investigational Site Number 124Boston, Massachusetts, United States, 02115|Ann Arbor, Michigan, United States, 48109 Investigational Site Number 120Detroit, Michigan, United States, 48202|Las Vegas, Nevada, United States, 89135|Chapel Hill, North Carolina, United States, 27517|Akron, Ohio, United States, 44308 Investigational Site Number 131Cleveland, Ohio, United States, 44106|Portland, Oregon, United States, 97239|Philadelphia, Pennsylvania, United States, 19104|Dallas, Texas, United States, 75390 Investigational Site Number 107Houston, Texas, United States, 77030-1312","Arizona|Arkansas|California|Florida|Illinois|Louisiana|Maryland|Massachusetts|Michigan|Nevada|North Carolina|Ohio|Oregon|Pennsylvania|Texas","Australia|Bulgaria|China|Denmark|France|Germany|Hungary|India|Israel|Italy|Japan|Malaysia|Portugal|South Africa|Spain|Turkey|Ukraine|United Kingdom|United States","Investigational Site Number 6101|Investigational Site Number 5901|Investigational Site Number 8604|Investigational Site Number 4501|Investigational Site Number 3303|Investigational Site Number 4904|Investigational Site Number 3602|Investigational Site Number 9102|Investigational Site Number 9701|Investigational Site Number 3901|Investigational Site Number 8105|Investigational Site Number 6004|Investigational Site Number 5104|Investigational Site Number 2701|Investigational Site Number 3402|Investigational Site Number 9002|Investigational Site Number 8001|Investigational Site Number 4402|Investigational Site Number 117|Investigational Site Number 0140|Investigational Site Number 0141|Investigational Site Number 128|Investigational Site Number 102|Investigational Site Number 119|Investigational Site Number 136|Investigational Site Number 121|Investigational Site Number 125|Investigational Site Number 111|Investigational Site Number 122|Investigational Site Number 110|Investigational Site Number 129|Investigational Site Number 104|Investigational Site Number 132",{"$nulls":3},"Clinical Sciences & Operations, MD","2020-02-24","2020-05-25T16:39:49.011","2020-05-26T17:10:42.972","NCT03417245"]
["5ecbf4d8feab101b15530a11","NCT03417830","2018-01-31","GlaxoSmithKline","GSK","Not yet recruiting","Biodistribution of 89Zirconium-labelled GSK2398852 Using PET Imaging","Cphpc|Dezamizumab",null,"Yes","['Cphpc', 'Dezamizumab']","Unknown",null,"Phase 1",2,6,"Anticipated","2018-02-13","2018-12-11","SUV","Standardized Uptake Value",{"$nulls":3},"The principal aim of this study is to investigate the cardiac uptake of 89Zr-GSK2398852 in subjects with transthyretin cardiomyopathy amyloidosis (ATTR-CM), and its biodistribution to other organs. Low doses of GSK2398852 will be co-administered at levels not high enough for therapeutic benefit. This study will be conducted in two parts: Part A and Part B. Subjects in Part A will participate in up to two dosing sessions and subjects in Part B will participate in one dosing session. Subjects will undergo up to 3 PET scans at varying intervals after 89Zr-GSK2398852 administration. The total duration of study will be approximately 3 to 4 months for subjects in Part A and approximately 2 months for subjects in Part B. Part B of the study will be triggered based on data obtained in Part A and other emerging data.",null,"An Adaptive, Open-Label Study to Evaluate the Biodistribution of 89Zirconium-labelled GSK2398852 in the Heart and Other Organs of Patients With Transthyretin Cardiomyopathy (ATTR-CM) Using Positron Emission Tomography (PET) Imaging",204512,"Amyloidosis","Amyloidosis","Metabolic Diseases","Nutritional Disorders","Experimental","Subjects with ATTR-CM in Part A|Subjects with ATTR-CM in Part B","Approximately 3 subjects with either wild type or inherited ATTR-CM will be included. Subjects in Part A will participate in two anti-SAP dosing sessions approximately 26 days in duration. The first two subjects in Part A will have up to three 89Zr PET scans, while the remaining subject will undergo up to two 89Zr PET scans.|Approximately 3 subjects with either wild type or inherited ATTR-CM will be included. Subjects in Part B will participate in one anti-SAP dosing session. Subjects will undergo up to two 89Zr PET scans.","Drug","GSK2315698 (CPHPC)|GSK2398852 (unlabeled anti-SAP mAb)|89Zr-GSK2398852 (89Zr-labeled anti-SAP mAb)","GSK2315698 will be administered as 20 milligrams per hour (20 mg/hour) IV infusion (in the vein) for up to 72 hours followed by 60 milligrams (mg) three times daily as SC injection for 8 days. Dose level and frequency will be adjusted according to renal function.|Subjects will be administered up to 490 mg of GSK2398852, IV. Dose level will be adjusted based on emerging imaging data.|89Zr-GSK2398852 will be available as solution containing 10 mg 89Zr-GSK2398852 for Infusion. Subjects will be administered 37 (Megabecquerel) MBq radioactive dose of 89Zr-GSK2398852 by the IV route at each dosing session.","miridesap|dezamizumab","Subjects with ATTR-CM in Part A|Subjects with ATTR-CM in Part B","\n\n * Subject must be 65 to 80 years of age inclusive, at the time of signing the informed consent.\n * Subjects with a diagnosis of ATTR-CM: a) Wild-type ATTR status must be confirmed by genotyping and have one of the following: i) Definite histochemical identification of amyloid by Congo red staining and green birefringence in crossed polarized light in cardiac or other tissue biopsy and identification of Transthyretin amyloidosis (TTR) as the amyloid fibril protein either by immunohistochemistry or proteomic analysis OR ii) Scintigraphy Technetium-99m-labeled 3,3-diphosphono-1,2-propanodicarboxylic acid (99mTc-DPD) with confirmed myocardial uptake. b) Hereditary ATTR amyloidosis (example, TTR Val30Met) should have a known amyloidogenic TTR mutation demonstrated by genotyping and is recognized to be primarily associated with cardiomyopathy and one of the following: i) Definite histochemical identification of amyloid by Congo red staining and green birefringence in crossed polarized light in cardiac or other tissue biopsy and identification of TTR as the amyloid fibril protein either by immunohistochemistry or proteomic analysis. ii) Scintigraphy: 99mTc-DPD with confirmed myocardial uptake.\n * Both male and female subjects are eligible to participate. a) Male subjects: A male subject must agree to use contraception during the treatment period and for at least 3 months after the last scan and refrain from donating sperm during this period. b) Female subjects: A female subject is eligible to participate if she is not of childbearing potential.\n * Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and protocol.\n * New York Heart Association (NYHA) up to class 3; subjects should be clinically stable for at least 3 months preceding to Screening.\n\n","\n\n * Cardiomyopathy primarily caused by non-amyloid diseases (example, ischemic heart disease; valvular heart disease).\n * Interval from the Q wave on the ECG to point T using Fredericia's formula (QTcF) >500 milliseconds (msec).\n * Sustained (at a rate of >=120 beats per minute for >=30 seconds), or symptomatic monomorphic ventricular tachycardia (VT), or rapid polymorphic VT, at Screening/Baseline cardiac monitoring.\n * Systolic blood pressure <=100 millimeters of mercury (mm/Hg) based on triplicate readings at Screening.\n * Unstable heart failure defined as emergency hospitalization for worsening, or decompensated heart failure, or syncopal episode within 1 month of screening.\n * Implantable cardiac defibrillator (ICD) or permanent pacemaker (PPM) at Screening.\n * Estimated Glomerular filtration rate (eGFR) at Screening <50 milliliters per minute (mL/min) calculated using modification of diet in renal disease (MDRD).\n * Any active and persistent dermatological condition, which in the opinion of the Investigator and Medical Monitor would preclude safe participation.\n * History of allogeneic stem cell transplantation, prior solid organ transplant, or anticipated to undergo solid organ transplantation, or left ventricular assist device (LVAD) implantation.\n * Malignancy within last 5 years, except for basal or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix that has been successfully treated.\n * Acute coronary syndrome, or any form of coronary revascularization procedure (including coronary artery bypass grafting [CABG]), within 6 months of screening.\n * Symptomatic, clinically significant autonomic neuropathy which the Principal Investigator (PI) feels will preclude administration of study treatment.\n * Uncontrolled hypertension during Screening.\n * ALT >3 times upper limit of normal (ULN) OR bilirubin >1.5 times ULN (isolated bilirubin >1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).\n * Peripheral edema at Screening that in the opinion of the PI or designee might prevent adequate absorption of subcutaneously administered CPHPC.\n * Presence of any co-morbid (example, steroid refractory rheumatoid arthritis), or an uncontrolled medical condition (example, diabetes mellitus), which in the opinion of the investigator would increase the potential risk to the subject. Investigator should liaise with the Medical Monitor where there is uncertainty as to the eligibility of a subject.\n * Positive test for hepatitis B, hepatitis C and/or human immunodeficiency virus (HIV) during Screening, or within 3 months prior to first dose of study treatment.\n * Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear immunoglobulin A [IgA] dermatosis, toxic epidermal necrolysis and exfoliative dermatitis).\n * Inability to comprehend and/or understand the study patient information sheet, and/or unwillingness or inability to follow the procedures outlined in the protocol.\n * Has any of the following: a) Fulfillment of diagnostic criteria for Amyloid Light-chain (AL) amyloidosis. b) Fulfillment of diagnostic criteria for amyloid A (AA) or non-TTR hereditary amyloidosis.\n * ATTR Disease Load: c) Histologically proven or clinically suspected gastrointestinal TTR amyloidosis; d) Diffuse skeletal muscle uptake of 99m(Tc)-DPD on Single-photon emission computed tomography (SPECT) imaging (where available); e) Peripheral neuropathy causing more than mild morbidity (example, walking disability; neuropathic pain affecting activities of daily living); f) Proven or clinically suspected intracranial TTR involvement including ophthalmological disease.\n * Non-amyloidosis related chronic liver disease (with the exception of Gilbert's syndrome or clinically asymptomatic gallstones).\n * Participation in a separate clinical trial involving CPHPC within 3 months of Screening.\n * Any prohibited concomitant medication within referenced timeframe.\n * Treatment with another investigational drug, biological agent, or device within 6 months of screening, or 5 half-lives of the study agent, whichever is longer.\n * Orthopnea of sufficient severity to preclude supine scanning as determined at Screening.\n * Inability to fit inside scanner due to body size (girth).\n * History of claustrophobia.\n * Contraindication to magnetic resonance imaging (MRI) contrast agents.\n * Contraindication for MRI scanning (as assessed by local MRI safety questionnaire), which includes but is not limited to: a) Intracranial aneurysm clips (except Sugita) or other metallic objects; b) Intra-orbital metal fragments that have not been removed; c) Pacemakers or other implanted cardiac rhythm management/monitoring devices and non-magnetic resonance (MR) conditional heart valves; d) Inner ear implants.\n * Donation of blood or blood products in excess of 500 milliliters (mL) within 84 days of Screening.\n * Poor or unsuitable venous access.","transthyretin",null,"Protein","Ovary","Actual","2018-01-31","Actual","Anticipated","2018-12-11","Anticipated","2018-01-01","2018-01-25","2018-01-25","2018-01-25","No","miridesap\nGSK2315698\n89Zirconium labelled\nPositron Emission Tomography\nTransthyretin cardiomyopathy\nGSK2398852\ndezamizumab","Interventional","Diagnostic","Sequential Assignment","None (Open Label)","Non-Randomized","65 Years","80 Years","All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":19},"Standardized Uptake Values (SUV) in focal anatomical regions of the heart following 80-200 milligrams (mg) dose of anti-SAP mAb|SUV in focal anatomical regions of the heart following an anti-SAP mAb dose between 200 mg and <=500 mg|SUV of whole heart following 80-200 mg dose of anti-SAP mAb|SUV of whole heart following an anti-SAP mAb dose between 200 mg and <=500 mg","PET images will be visually reviewed to assess the radioactivity distribution. SUV is the measured radioactivity concentration corrected for radioactive decay and normalized for administered amount of radioactivity per body weight.","Up to Day 6","Focal radioactivity uptake after 80-200 mg dose of anti-SAP mAb|Focal radioactivity uptake after an anti-SAP mAb dose between 200 mg and <=500 mg|Total radioactivity uptake after 80-200 mg dose of anti-SAP mAb|Total radioactivity uptake after an anti-SAP mAb dose between 200 mg and <=500 mg|Maximum concentration in plasma (Cmax) of total mAb|Time associated with Cmax (Tmax) of total mAb|Clearance of total mAb|Terminal half-life (T1/2) of total mAb|Area under the concentration-time profile (AUC) of total mAb|Cmax of 89Zr- GSK2398852 pharmacokinetics of radioactivity (radio-PK)|Tmax of 89Zr- GSK2398852 radio-PK|T1/2 of 89Zr- GSK2398852 radio-PK|AUC of 89Zr- GSK2398852 radio-PK|Number of subjects with adverse events (AEs) and serious adverse events (SAEs)|Number of subjects with skin rashes|Number of subjects with cardiac adverse events|Number of subjects with infusion related reactions|Number of subjects with abnormal hematology parameters|Number of subjects with abnormal clinical chemistry parameters|Number of subjects with abnormal urine parameters|Number of subjects with cardiac safety parameters of clinical significance|Number of subjects with abnormal electrocardiogram (ECG)|Number of subjects with abnormal inpatient cardiac telemetry|Number of subjects with abnormal outpatient cardiac telemetry|Number of subjects with abnormal temperature|Number of subjects with abnormal blood pressure|Number of subjects with abnormal pulse rate|Number of subjects with abnormal respiratory rate|Number of subjects with abnormal physical examination findings","PET images will be visually reviewed to assess the radioactivity distribution. SUV is the measured radioactivity concentration corrected for radioactive decay and normalized for administered amount of radioactivity per body weight. Focal radioactivity uptake in different tissues will be evaluated.|PET images will be visually reviewed to assess the radioactivity distribution. SUV is the measured radioactivity concentration corrected for radioactive decay and normalized for administered amount of radioactivity per body weight. Total radioactivity uptake in different tissues will be evaluated.|Blood samples will be collected at indicated time points for measurement of plasma concentrations of GSK2398852. Plasma concentrations of GSK2398852, will be the total of both 89Zr-labeled and unlabeled mAb.|Blood samples will be collected at indicated time points for measurement of radioactivity. The radioactivity will reflect the total concentration of 89Zr-GSK2398852 and its radioactive metabolites. Plasma radioactive concentration will be measured by scintillation counter.|An AE is any untoward medical occurrence in a clinical study subject, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; other important medical events which may require medical or surgical intervention.|Rash will be graded as Grade 1 to Grade 4 based on symptoms and body surface area affected.|Cardiovascular adverse events will include myocardial infarction/unstable angina, congestive heart failure, arrhythmias, valvulopathy, pulmonary hypertension, cerebrovascular events/stroke and transient ischemic attack, peripheral arterial thromboembolism, deep venous thrombosis/pulmonary embolism and revascularization.|Number of subjects with infusion related reactions will be summarized.|The following hematology parameters will be assessed: platelet count, red blood cell (RBC) count, hemoglobin, hematocrit, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), percentage of reticulocytes, neutrophils, lymphocytes, monocytes, eosinophils and basophils.|The following clinical chemistry parameters will be evaluated: blood urea nitrogen (BUN), creatinine, glucose (non-fasting), potassium, sodium, calcium, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase, total and direct bilirubin, total protein and albumin.|The following parameters will be evaluated: specific gravity, potential hydrogen (pH), glucose, protein, blood and ketones by dipstick method. Urine microscopy will be performed if indicated.|The following cardiac chemistry parameters will be evaluated: troponin T and N-terminal prohormone of brain natriuretic peptide (NT-ProBNP).|12-lead ECGs will be obtained in a semi-supine position using an automated ECG machine after approximately 5 minutes of rest for the subject.|Inpatient cardiac monitoring will be performed using inpatient lead II cardiac telemetry.|Outpatient cardiac monitoring will be performed using a non-implantable remote cardiac telemetry device.|Temperature will be measured in a semi-supine position after 5 minutes of rest.|Systolic and diastolic blood pressure will be measured in a semi-supine position after 5 minutes of rest.|Pulse rate will be measured in a semi-supine position after 5 minutes of rest.|Respiratory rate will be measured in a semi-supine position after 5 minutes of rest.|A brief physical examination will be performed, including assessments of the skin, lungs, cardiovascular system and abdomen (liver and spleen).","Up to Day 6|Day 3 (pre-dose, 4 hours, 7 hours post-dose), Day 4, Day 5, Day 6 and Day 7 post-dose|Day 3 (10 minutes, 60 minutes, 4 hours, 7 hours post-dose), Day 4, Day 5 and Day 6 post-dose|Up to Day 28|Up to Day 11|Up to Day 18","GSKClinicalSupportHD@gsk.com","US GSK Clinical Trials Call Center","877-379-3718",{"$nulls":7},"GSK Clinical Trials","2018-01-25","2020-05-25T16:39:52.508","2020-05-26T17:10:42.972","NCT03417830"]
["5ecbf4d811702c1b1b916bee","NCT03417830","2018-02-22","GlaxoSmithKline","GSK","Not yet recruiting","Biodistribution of 89Zirconium-labelled GSK2398852 Using PET Imaging","Cphpc|Dezamizumab",null,"Yes","['Cphpc', 'Dezamizumab']","Unknown",null,"Phase 1",2,6,"Anticipated","2018-03-03","2018-12-18","SUV","Standardized Uptake Value",{"$nulls":3},"The principal aim of this study is to investigate the cardiac uptake of 89Zr-GSK2398852 in subjects with transthyretin cardiomyopathy amyloidosis (ATTR-CM), and its biodistribution to other organs. Low doses of GSK2398852 will be co-administered at levels not high enough for therapeutic benefit. This study will be conducted in two parts: Part A and Part B. Subjects in Part A will participate in up to two dosing sessions and subjects in Part B will participate in one dosing session. Subjects will undergo up to 3 PET scans at varying intervals after 89Zr-GSK2398852 administration. The total duration of study will be approximately 3 to 4 months for subjects in Part A and approximately 2 months for subjects in Part B. Part B of the study will be triggered based on data obtained in Part A and other emerging data.",null,"An Adaptive, Open-Label Study to Evaluate the Biodistribution of 89Zirconium-labelled GSK2398852 in the Heart and Other Organs of Patients With Transthyretin Cardiomyopathy (ATTR-CM) Using Positron Emission Tomography (PET) Imaging",204512,"Amyloidosis","Amyloidosis","Metabolic Diseases","Nutritional Disorders","Experimental","Subjects with ATTR-CM in Part A|Subjects with ATTR-CM in Part B","Approximately 3 subjects with either wild type or inherited ATTR-CM will be included. Subjects in Part A will participate in two anti-SAP dosing sessions approximately 26 days in duration. The first two subjects in Part A will have up to three 89Zr PET scans, while the remaining subject will undergo up to two 89Zr PET scans.|Approximately 3 subjects with either wild type or inherited ATTR-CM will be included. Subjects in Part B will participate in one anti-SAP dosing session. Subjects will undergo up to two 89Zr PET scans.","Drug","GSK2315698 (CPHPC)|GSK2398852 (unlabeled anti-SAP mAb)|89Zr-GSK2398852 (89Zr-labeled anti-SAP mAb)","GSK2315698 will be administered as 20 milligrams per hour (20 mg/hour) IV infusion (in the vein) for up to 72 hours followed by 60 milligrams (mg) three times daily as SC injection for 8 days. Dose level and frequency will be adjusted according to renal function.|Subjects will be administered up to 490 mg of GSK2398852, IV. Dose level will be adjusted based on emerging imaging data.|89Zr-GSK2398852 will be available as solution containing 10 mg 89Zr-GSK2398852 for Infusion. Subjects will be administered 37 (Megabecquerel) MBq radioactive dose of 89Zr-GSK2398852 by the IV route at each dosing session.","miridesap|dezamizumab","Subjects with ATTR-CM in Part A|Subjects with ATTR-CM in Part B","\n\n * Subject must be 65 to 80 years of age inclusive, at the time of signing the informed consent.\n * Subjects with a diagnosis of ATTR-CM: a) Wild-type ATTR status must be confirmed by genotyping and have one of the following: i) Definite histochemical identification of amyloid by Congo red staining and green birefringence in crossed polarized light in cardiac or other tissue biopsy and identification of Transthyretin amyloidosis (TTR) as the amyloid fibril protein either by immunohistochemistry or proteomic analysis OR ii) Scintigraphy Technetium-99m-labeled 3,3-diphosphono-1,2-propanodicarboxylic acid (99mTc-DPD) with confirmed myocardial uptake. b) Hereditary ATTR amyloidosis (example, TTR Val30Met) should have a known amyloidogenic TTR mutation demonstrated by genotyping and is recognized to be primarily associated with cardiomyopathy and one of the following: i) Definite histochemical identification of amyloid by Congo red staining and green birefringence in crossed polarized light in cardiac or other tissue biopsy and identification of TTR as the amyloid fibril protein either by immunohistochemistry or proteomic analysis. ii) Scintigraphy: 99mTc-DPD with confirmed myocardial uptake.\n * Both male and female subjects are eligible to participate. a) Male subjects: A male subject must agree to use contraception during the treatment period and for at least 3 months after the last scan and refrain from donating sperm during this period. b) Female subjects: A female subject is eligible to participate if she is not of childbearing potential.\n * Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and protocol.\n * New York Heart Association (NYHA) up to class 3; subjects should be clinically stable for at least 3 months preceding to Screening.\n\n","\n\n * Cardiomyopathy primarily caused by non-amyloid diseases (example, ischemic heart disease; valvular heart disease).\n * Interval from the Q wave on the ECG to point T using Fredericia's formula (QTcF) >500 milliseconds (msec).\n * Sustained (at a rate of >=120 beats per minute for >=30 seconds), or symptomatic monomorphic ventricular tachycardia (VT), or rapid polymorphic VT, at Screening/Baseline cardiac monitoring.\n * Systolic blood pressure <=100 millimeters of mercury (mm/Hg) based on triplicate readings at Screening.\n * Unstable heart failure defined as emergency hospitalization for worsening, or decompensated heart failure, or syncopal episode within 1 month of screening.\n * Implantable cardiac defibrillator (ICD) or permanent pacemaker (PPM) at Screening.\n * Estimated Glomerular filtration rate (eGFR) at Screening <50 milliliters per minute (mL/min) calculated using modification of diet in renal disease (MDRD).\n * Any active and persistent dermatological condition, which in the opinion of the Investigator and Medical Monitor would preclude safe participation.\n * History of allogeneic stem cell transplantation, prior solid organ transplant, or anticipated to undergo solid organ transplantation, or left ventricular assist device (LVAD) implantation.\n * Malignancy within last 5 years, except for basal or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix that has been successfully treated.\n * Acute coronary syndrome, or any form of coronary revascularization procedure (including coronary artery bypass grafting [CABG]), within 6 months of screening.\n * Symptomatic, clinically significant autonomic neuropathy which the Principal Investigator (PI) feels will preclude administration of study treatment.\n * Uncontrolled hypertension during Screening.\n * ALT >3 times upper limit of normal (ULN) OR bilirubin >1.5 times ULN (isolated bilirubin >1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).\n * Peripheral edema at Screening that in the opinion of the PI or designee might prevent adequate absorption of subcutaneously administered CPHPC.\n * Presence of any co-morbid (example, steroid refractory rheumatoid arthritis), or an uncontrolled medical condition (example, diabetes mellitus), which in the opinion of the investigator would increase the potential risk to the subject. Investigator should liaise with the Medical Monitor where there is uncertainty as to the eligibility of a subject.\n * Positive test for hepatitis B, hepatitis C and/or human immunodeficiency virus (HIV) during Screening, or within 3 months prior to first dose of study treatment.\n * Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear immunoglobulin A [IgA] dermatosis, toxic epidermal necrolysis and exfoliative dermatitis).\n * Inability to comprehend and/or understand the study patient information sheet, and/or unwillingness or inability to follow the procedures outlined in the protocol.\n * Has any of the following: a) Fulfillment of diagnostic criteria for Amyloid Light-chain (AL) amyloidosis. b) Fulfillment of diagnostic criteria for amyloid A (AA) or non-TTR hereditary amyloidosis.\n * ATTR Disease Load: c) Histologically proven or clinically suspected gastrointestinal TTR amyloidosis; d) Diffuse skeletal muscle uptake of 99m(Tc)-DPD on Single-photon emission computed tomography (SPECT) imaging (where available); e) Peripheral neuropathy causing more than mild morbidity (example, walking disability; neuropathic pain affecting activities of daily living); f) Proven or clinically suspected intracranial TTR involvement including ophthalmological disease.\n * Non-amyloidosis related chronic liver disease (with the exception of Gilbert's syndrome or clinically asymptomatic gallstones).\n * Participation in a separate clinical trial involving CPHPC within 3 months of Screening.\n * Any prohibited concomitant medication within referenced timeframe.\n * Treatment with another investigational drug, biological agent, or device within 6 months of screening, or 5 half-lives of the study agent, whichever is longer.\n * Orthopnea of sufficient severity to preclude supine scanning as determined at Screening.\n * Inability to fit inside scanner due to body size (girth).\n * History of claustrophobia.\n * Contraindication to magnetic resonance imaging (MRI) contrast agents.\n * Contraindication for MRI scanning (as assessed by local MRI safety questionnaire), which includes but is not limited to: a) Intracranial aneurysm clips (except Sugita) or other metallic objects; b) Intra-orbital metal fragments that have not been removed; c) Pacemakers or other implanted cardiac rhythm management/monitoring devices and non-magnetic resonance (MR) conditional heart valves; d) Inner ear implants.\n * Donation of blood or blood products in excess of 500 milliliters (mL) within 84 days of Screening.\n * Poor or unsuitable venous access.","transthyretin",null,"Protein","Ovary","Actual","2018-01-31","Actual","Anticipated","2018-12-18","Anticipated","2018-02-01","2018-01-25","2018-01-25","2018-02-21","No","miridesap\nGSK2315698\n89Zirconium labelled\nPositron Emission Tomography\nTransthyretin cardiomyopathy\nGSK2398852\ndezamizumab","Interventional","Diagnostic","Sequential Assignment","None (Open Label)","Non-Randomized","65 Years","80 Years","All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":19},"Standardized Uptake Values (SUV) in focal anatomical regions of the heart following 80-200 milligrams (mg) dose of anti-SAP mAb|SUV in focal anatomical regions of the heart following an anti-SAP mAb dose between 200 mg and <=500 mg|SUV of whole heart following 80-200 mg dose of anti-SAP mAb|SUV of whole heart following an anti-SAP mAb dose between 200 mg and <=500 mg","PET images will be visually reviewed to assess the radioactivity distribution. SUV is the measured radioactivity concentration corrected for radioactive decay and normalized for administered amount of radioactivity per body weight.","Up to Day 6","Focal radioactivity uptake after 80-200 mg dose of anti-SAP mAb|Focal radioactivity uptake after an anti-SAP mAb dose between 200 mg and <=500 mg|Total radioactivity uptake after 80-200 mg dose of anti-SAP mAb|Total radioactivity uptake after an anti-SAP mAb dose between 200 mg and <=500 mg|Maximum concentration in plasma (Cmax) of total mAb|Time associated with Cmax (Tmax) of total mAb|Clearance of total mAb|Terminal half-life (T1/2) of total mAb|Area under the concentration-time profile (AUC) of total mAb|Cmax of 89Zr- GSK2398852 pharmacokinetics of radioactivity (radio-PK)|Tmax of 89Zr- GSK2398852 radio-PK|T1/2 of 89Zr- GSK2398852 radio-PK|AUC of 89Zr- GSK2398852 radio-PK|Number of subjects with adverse events (AEs) and serious adverse events (SAEs)|Number of subjects with skin rashes|Number of subjects with cardiac adverse events|Number of subjects with infusion related reactions|Number of subjects with abnormal hematology parameters|Number of subjects with abnormal clinical chemistry parameters|Number of subjects with abnormal urine parameters|Number of subjects with cardiac safety parameters of clinical significance|Number of subjects with abnormal electrocardiogram (ECG)|Number of subjects with abnormal inpatient cardiac telemetry|Number of subjects with abnormal outpatient cardiac telemetry|Number of subjects with abnormal temperature|Number of subjects with abnormal blood pressure|Number of subjects with abnormal pulse rate|Number of subjects with abnormal respiratory rate|Number of subjects with abnormal physical examination findings","PET images will be visually reviewed to assess the radioactivity distribution. SUV is the measured radioactivity concentration corrected for radioactive decay and normalized for administered amount of radioactivity per body weight. Focal radioactivity uptake in different tissues will be evaluated.|PET images will be visually reviewed to assess the radioactivity distribution. SUV is the measured radioactivity concentration corrected for radioactive decay and normalized for administered amount of radioactivity per body weight. Total radioactivity uptake in different tissues will be evaluated.|Blood samples will be collected at indicated time points for measurement of plasma concentrations of GSK2398852. Plasma concentrations of GSK2398852, will be the total of both 89Zr-labeled and unlabeled mAb.|Blood samples will be collected at indicated time points for measurement of radioactivity. The radioactivity will reflect the total concentration of 89Zr-GSK2398852 and its radioactive metabolites. Plasma radioactive concentration will be measured by scintillation counter.|An AE is any untoward medical occurrence in a clinical study subject, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; other important medical events which may require medical or surgical intervention.|Rash will be graded as Grade 1 to Grade 4 based on symptoms and body surface area affected.|Cardiovascular adverse events will include myocardial infarction/unstable angina, congestive heart failure, arrhythmias, valvulopathy, pulmonary hypertension, cerebrovascular events/stroke and transient ischemic attack, peripheral arterial thromboembolism, deep venous thrombosis/pulmonary embolism and revascularization.|Number of subjects with infusion related reactions will be summarized.|The following hematology parameters will be assessed: platelet count, red blood cell (RBC) count, hemoglobin, hematocrit, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), percentage of reticulocytes, neutrophils, lymphocytes, monocytes, eosinophils and basophils.|The following clinical chemistry parameters will be evaluated: blood urea nitrogen (BUN), creatinine, glucose (non-fasting), potassium, sodium, calcium, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase, total and direct bilirubin, total protein and albumin.|The following parameters will be evaluated: specific gravity, potential hydrogen (pH), glucose, protein, blood and ketones by dipstick method. Urine microscopy will be performed if indicated.|The following cardiac chemistry parameters will be evaluated: troponin T and N-terminal prohormone of brain natriuretic peptide (NT-ProBNP).|12-lead ECGs will be obtained in a semi-supine position using an automated ECG machine after approximately 5 minutes of rest for the subject.|Inpatient cardiac monitoring will be performed using inpatient lead II cardiac telemetry.|Outpatient cardiac monitoring will be performed using a non-implantable remote cardiac telemetry device.|Temperature will be measured in a semi-supine position after 5 minutes of rest.|Systolic and diastolic blood pressure will be measured in a semi-supine position after 5 minutes of rest.|Pulse rate will be measured in a semi-supine position after 5 minutes of rest.|Respiratory rate will be measured in a semi-supine position after 5 minutes of rest.|A brief physical examination will be performed, including assessments of the skin, lungs, cardiovascular system and abdomen (liver and spleen).","Up to Day 6|Day 3 (pre-dose, 4 hours, 7 hours post-dose), Day 4, Day 5, Day 6 and Day 7 post-dose|Day 3 (10 minutes, 60 minutes, 4 hours, 7 hours post-dose), Day 4, Day 5 and Day 6 post-dose|Up to Day 28|Up to Day 11|Up to Day 18","GSKClinicalSupportHD@gsk.com","US GSK Clinical Trials Call Center","877-379-3718",{"$nulls":7},"GSK Clinical Trials","2018-02-21","2020-05-25T16:39:52.141","2020-05-26T17:10:42.972","NCT03417830"]
["5ecbf4d8307e3d1b1f8d9e74","NCT03417830","2018-03-19","GlaxoSmithKline","GSK","Not yet recruiting","Biodistribution of 89Zirconium-labelled GSK2398852 Using PET Imaging","Cphpc|Dezamizumab",null,"Yes","['Cphpc', 'Dezamizumab']","Unknown",null,"Phase 1",2,6,"Anticipated","2018-03-30","2018-12-18","SUV","Standardized Uptake Value",{"$nulls":3},"The principal aim of this study is to investigate the cardiac uptake of 89Zr-GSK2398852 in subjects with transthyretin cardiomyopathy amyloidosis (ATTR-CM), and its biodistribution to other organs. Low doses of GSK2398852 will be co-administered at levels not high enough for therapeutic benefit. This study will be conducted in two parts: Part A and Part B. Subjects in Part A will participate in up to two dosing sessions and subjects in Part B will participate in one dosing session. Subjects will undergo up to 3 PET scans at varying intervals after 89Zr-GSK2398852 administration. The total duration of study will be approximately 3 to 4 months for subjects in Part A and approximately 2 months for subjects in Part B. Part B of the study will be triggered based on data obtained in Part A and other emerging data.",null,"An Adaptive, Open-Label Study to Evaluate the Biodistribution of 89Zirconium-labelled GSK2398852 in the Heart and Other Organs of Patients With Transthyretin Cardiomyopathy (ATTR-CM) Using Positron Emission Tomography (PET) Imaging",204512,"Amyloidosis","Amyloidosis","Metabolic Diseases","Nutritional Disorders","Experimental","Subjects with ATTR-CM in Part A|Subjects with ATTR-CM in Part B","Approximately 3 subjects with either wild type or inherited ATTR-CM will be included. Subjects in Part A will participate in two anti-SAP dosing sessions approximately 26 days in duration. The first two subjects in Part A will have up to three 89Zr PET scans, while the remaining subject will undergo up to two 89Zr PET scans.|Approximately 3 subjects with either wild type or inherited ATTR-CM will be included. Subjects in Part B will participate in one anti-SAP dosing session. Subjects will undergo up to two 89Zr PET scans.","Drug","GSK2315698 (CPHPC)|GSK2398852 (unlabeled anti-SAP mAb)|89Zr-GSK2398852 (89Zr-labeled anti-SAP mAb)","GSK2315698 will be administered as 20 milligrams per hour (20 mg/hour) IV infusion (in the vein) for up to 72 hours followed by 60 milligrams (mg) three times daily as SC injection for 8 days. Dose level and frequency will be adjusted according to renal function.|Subjects will be administered up to 490 mg of GSK2398852, IV. Dose level will be adjusted based on emerging imaging data.|89Zr-GSK2398852 will be available as solution containing 10 mg 89Zr-GSK2398852 for Infusion. Subjects will be administered 37 (Megabecquerel) MBq radioactive dose of 89Zr-GSK2398852 by the IV route at each dosing session.","miridesap|dezamizumab","Subjects with ATTR-CM in Part A|Subjects with ATTR-CM in Part B","\n\n * Subject must be 65 to 80 years of age inclusive, at the time of signing the informed consent.\n * Subjects with a diagnosis of ATTR-CM: a) Wild-type ATTR status must be confirmed by genotyping and have one of the following: i) Definite histochemical identification of amyloid by Congo red staining and green birefringence in crossed polarized light in cardiac or other tissue biopsy and identification of Transthyretin amyloidosis (TTR) as the amyloid fibril protein either by immunohistochemistry or proteomic analysis OR ii) Scintigraphy Technetium-99m-labeled 3,3-diphosphono-1,2-propanodicarboxylic acid (99mTc-DPD) with confirmed myocardial uptake. b) Hereditary ATTR amyloidosis (example, TTR Val30Met) should have a known amyloidogenic TTR mutation demonstrated by genotyping and is recognized to be primarily associated with cardiomyopathy and one of the following: i) Definite histochemical identification of amyloid by Congo red staining and green birefringence in crossed polarized light in cardiac or other tissue biopsy and identification of TTR as the amyloid fibril protein either by immunohistochemistry or proteomic analysis. ii) Scintigraphy: 99mTc-DPD with confirmed myocardial uptake.\n * Both male and female subjects are eligible to participate. a) Male subjects: A male subject must agree to use contraception during the treatment period and for at least 3 months after the last scan and refrain from donating sperm during this period. b) Female subjects: A female subject is eligible to participate if she is not of childbearing potential.\n * Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and protocol.\n * New York Heart Association (NYHA) up to class 3; subjects should be clinically stable for at least 3 months preceding to Screening.\n\n","\n\n * Cardiomyopathy primarily caused by non-amyloid diseases (example, ischemic heart disease; valvular heart disease).\n * Interval from the Q wave on the ECG to point T using Fredericia's formula (QTcF) >500 milliseconds (msec).\n * Sustained (at a rate of >=120 beats per minute for >=30 seconds), or symptomatic monomorphic ventricular tachycardia (VT), or rapid polymorphic VT, at Screening/Baseline cardiac monitoring.\n * Systolic blood pressure <=100 millimeters of mercury (mm/Hg) based on triplicate readings at Screening.\n * Unstable heart failure defined as emergency hospitalization for worsening, or decompensated heart failure, or syncopal episode within 1 month of screening.\n * Implantable cardiac defibrillator (ICD) or permanent pacemaker (PPM) at Screening.\n * Estimated Glomerular filtration rate (eGFR) at Screening <50 milliliters per minute (mL/min) calculated using modification of diet in renal disease (MDRD).\n * Any active and persistent dermatological condition, which in the opinion of the Investigator and Medical Monitor would preclude safe participation.\n * History of allogeneic stem cell transplantation, prior solid organ transplant, or anticipated to undergo solid organ transplantation, or left ventricular assist device (LVAD) implantation.\n * Malignancy within last 5 years, except for basal or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix that has been successfully treated.\n * Acute coronary syndrome, or any form of coronary revascularization procedure (including coronary artery bypass grafting [CABG]), within 6 months of screening.\n * Symptomatic, clinically significant autonomic neuropathy which the Principal Investigator (PI) feels will preclude administration of study treatment.\n * Uncontrolled hypertension during Screening.\n * ALT >3 times upper limit of normal (ULN) OR bilirubin >1.5 times ULN (isolated bilirubin >1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).\n * Peripheral edema at Screening that in the opinion of the PI or designee might prevent adequate absorption of subcutaneously administered CPHPC.\n * Presence of any co-morbid (example, steroid refractory rheumatoid arthritis), or an uncontrolled medical condition (example, diabetes mellitus), which in the opinion of the investigator would increase the potential risk to the subject. Investigator should liaise with the Medical Monitor where there is uncertainty as to the eligibility of a subject.\n * Positive test for hepatitis B, hepatitis C and/or human immunodeficiency virus (HIV) during Screening, or within 3 months prior to first dose of study treatment.\n * Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear immunoglobulin A [IgA] dermatosis, toxic epidermal necrolysis and exfoliative dermatitis).\n * Inability to comprehend and/or understand the study patient information sheet, and/or unwillingness or inability to follow the procedures outlined in the protocol.\n * Has any of the following: a) Fulfillment of diagnostic criteria for Amyloid Light-chain (AL) amyloidosis. b) Fulfillment of diagnostic criteria for amyloid A (AA) or non-TTR hereditary amyloidosis.\n * ATTR Disease Load: c) Histologically proven or clinically suspected gastrointestinal TTR amyloidosis; d) Diffuse skeletal muscle uptake of 99m(Tc)-DPD on Single-photon emission computed tomography (SPECT) imaging (where available); e) Peripheral neuropathy causing more than mild morbidity (example, walking disability; neuropathic pain affecting activities of daily living); f) Proven or clinically suspected intracranial TTR involvement including ophthalmological disease.\n * Non-amyloidosis related chronic liver disease (with the exception of Gilbert's syndrome or clinically asymptomatic gallstones).\n * Participation in a separate clinical trial involving CPHPC within 3 months of Screening.\n * Any prohibited concomitant medication within referenced timeframe.\n * Treatment with another investigational drug, biological agent, or device within 6 months of screening, or 5 half-lives of the study agent, whichever is longer.\n * Orthopnea of sufficient severity to preclude supine scanning as determined at Screening.\n * Inability to fit inside scanner due to body size (girth).\n * History of claustrophobia.\n * Contraindication to magnetic resonance imaging (MRI) contrast agents.\n * Contraindication for MRI scanning (as assessed by local MRI safety questionnaire), which includes but is not limited to: a) Intracranial aneurysm clips (except Sugita) or other metallic objects; b) Intra-orbital metal fragments that have not been removed; c) Pacemakers or other implanted cardiac rhythm management/monitoring devices and non-magnetic resonance (MR) conditional heart valves; d) Inner ear implants.\n * Donation of blood or blood products in excess of 500 milliliters (mL) within 84 days of Screening.\n * Poor or unsuitable venous access.","transthyretin",null,"Protein","Ovary","Actual","2018-01-31","Actual","Anticipated","2018-12-18","Anticipated","2018-03-01","2018-01-25","2018-01-25","2018-03-15","No","miridesap\nGSK2315698\n89Zirconium labelled\nPositron Emission Tomography\nTransthyretin cardiomyopathy\nGSK2398852\ndezamizumab","Interventional","Diagnostic","Sequential Assignment","None (Open Label)","Non-Randomized","65 Years","80 Years","All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":19},"Standardized Uptake Values (SUV) in focal anatomical regions of the heart following 80-200 milligrams (mg) dose of anti-SAP mAb|SUV in focal anatomical regions of the heart following an anti-SAP mAb dose between 200 mg and <=500 mg|SUV of whole heart following 80-200 mg dose of anti-SAP mAb|SUV of whole heart following an anti-SAP mAb dose between 200 mg and <=500 mg","PET images will be visually reviewed to assess the radioactivity distribution. SUV is the measured radioactivity concentration corrected for radioactive decay and normalized for administered amount of radioactivity per body weight.","Up to Day 6","Focal radioactivity uptake after 80-200 mg dose of anti-SAP mAb|Focal radioactivity uptake after an anti-SAP mAb dose between 200 mg and <=500 mg|Total radioactivity uptake after 80-200 mg dose of anti-SAP mAb|Total radioactivity uptake after an anti-SAP mAb dose between 200 mg and <=500 mg|Maximum concentration in plasma (Cmax) of total mAb|Time associated with Cmax (Tmax) of total mAb|Clearance of total mAb|Terminal half-life (T1/2) of total mAb|Area under the concentration-time profile (AUC) of total mAb|Cmax of 89Zr- GSK2398852 pharmacokinetics of radioactivity (radio-PK)|Tmax of 89Zr- GSK2398852 radio-PK|T1/2 of 89Zr- GSK2398852 radio-PK|AUC of 89Zr- GSK2398852 radio-PK|Number of subjects with adverse events (AEs) and serious adverse events (SAEs)|Number of subjects with skin rashes|Number of subjects with cardiac adverse events|Number of subjects with infusion related reactions|Number of subjects with abnormal hematology parameters|Number of subjects with abnormal clinical chemistry parameters|Number of subjects with abnormal urine parameters|Number of subjects with cardiac safety parameters of clinical significance|Number of subjects with abnormal electrocardiogram (ECG)|Number of subjects with abnormal inpatient cardiac telemetry|Number of subjects with abnormal outpatient cardiac telemetry|Number of subjects with abnormal temperature|Number of subjects with abnormal blood pressure|Number of subjects with abnormal pulse rate|Number of subjects with abnormal respiratory rate|Number of subjects with abnormal physical examination findings","PET images will be visually reviewed to assess the radioactivity distribution. SUV is the measured radioactivity concentration corrected for radioactive decay and normalized for administered amount of radioactivity per body weight. Focal radioactivity uptake in different tissues will be evaluated.|PET images will be visually reviewed to assess the radioactivity distribution. SUV is the measured radioactivity concentration corrected for radioactive decay and normalized for administered amount of radioactivity per body weight. Total radioactivity uptake in different tissues will be evaluated.|Blood samples will be collected at indicated time points for measurement of plasma concentrations of GSK2398852. Plasma concentrations of GSK2398852, will be the total of both 89Zr-labeled and unlabeled mAb.|Blood samples will be collected at indicated time points for measurement of radioactivity. The radioactivity will reflect the total concentration of 89Zr-GSK2398852 and its radioactive metabolites. Plasma radioactive concentration will be measured by scintillation counter.|An AE is any untoward medical occurrence in a clinical study subject, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; other important medical events which may require medical or surgical intervention.|Rash will be graded as Grade 1 to Grade 4 based on symptoms and body surface area affected.|Cardiovascular adverse events will include myocardial infarction/unstable angina, congestive heart failure, arrhythmias, valvulopathy, pulmonary hypertension, cerebrovascular events/stroke and transient ischemic attack, peripheral arterial thromboembolism, deep venous thrombosis/pulmonary embolism and revascularization.|Number of subjects with infusion related reactions will be summarized.|The following hematology parameters will be assessed: platelet count, red blood cell (RBC) count, hemoglobin, hematocrit, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), percentage of reticulocytes, neutrophils, lymphocytes, monocytes, eosinophils and basophils.|The following clinical chemistry parameters will be evaluated: blood urea nitrogen (BUN), creatinine, glucose (non-fasting), potassium, sodium, calcium, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase, total and direct bilirubin, total protein and albumin.|The following parameters will be evaluated: specific gravity, potential hydrogen (pH), glucose, protein, blood and ketones by dipstick method. Urine microscopy will be performed if indicated.|The following cardiac chemistry parameters will be evaluated: troponin T and N-terminal prohormone of brain natriuretic peptide (NT-ProBNP).|12-lead ECGs will be obtained in a semi-supine position using an automated ECG machine after approximately 5 minutes of rest for the subject.|Inpatient cardiac monitoring will be performed using inpatient lead II cardiac telemetry.|Outpatient cardiac monitoring will be performed using a non-implantable remote cardiac telemetry device.|Temperature will be measured in a semi-supine position after 5 minutes of rest.|Systolic and diastolic blood pressure will be measured in a semi-supine position after 5 minutes of rest.|Pulse rate will be measured in a semi-supine position after 5 minutes of rest.|Respiratory rate will be measured in a semi-supine position after 5 minutes of rest.|A brief physical examination will be performed, including assessments of the skin, lungs, cardiovascular system and abdomen (liver and spleen).","Up to Day 6|Day 3 (pre-dose, 4 hours, 7 hours post-dose), Day 4, Day 5, Day 6 and Day 7 post-dose|Day 3 (10 minutes, 60 minutes, 4 hours, 7 hours post-dose), Day 4, Day 5 and Day 6 post-dose|Up to Day 28|Up to Day 11|Up to Day 18","GSKClinicalSupportHD@gsk.com","US GSK Clinical Trials Call Center","877-379-3718","Uppsala, Sweden, Se-751 85",null,"Sweden","Gsk Investigational Site",{"$nulls":3},"GSK Clinical Trials","2018-03-15","2020-05-25T16:39:52.560","2020-05-26T17:10:42.972","NCT03417830"]
["5ecbf4d8fe30261b1a0483e3","NCT03417830","2018-05-22","GlaxoSmithKline","GSK","Recruiting","Biodistribution of 89Zirconium-labelled GSK2398852 Using PET Imaging","Cphpc|Dezamizumab",null,"Yes","['Cphpc', 'Dezamizumab']","Unknown",null,"Phase 1",2,6,"Anticipated","2018-04-06","2018-12-11","SUV","Standardized Uptake Value",{"$nulls":3},"The principal aim of this study is to investigate the cardiac uptake of 89Zr-GSK2398852 in subjects with transthyretin cardiomyopathy amyloidosis (ATTR-CM), and its biodistribution to other organs. Low doses of GSK2398852 will be co-administered at levels not high enough for therapeutic benefit. This study will be conducted in two parts: Part A and Part B. Subjects in Part A will participate in up to two dosing sessions and subjects in Part B will participate in one dosing session. Subjects will undergo up to 3 PET scans at varying intervals after 89Zr-GSK2398852 administration. The total duration of study will be approximately 3 to 4 months for subjects in Part A and approximately 2 months for subjects in Part B. Part B of the study will be triggered based on data obtained in Part A and other emerging data.",null,"An Adaptive, Open-Label Study to Evaluate the Biodistribution of 89Zirconium-labelled GSK2398852 in the Heart and Other Organs of Patients With Transthyretin Cardiomyopathy (ATTR-CM) Using Positron Emission Tomography (PET) Imaging",204512,"Amyloidosis","Amyloidosis","Metabolic Diseases","Nutritional Disorders","Experimental","Subjects with ATTR-CM in Part A|Subjects with ATTR-CM in Part B","Approximately 3 subjects with either wild type or inherited ATTR-CM will be included. Subjects in Part A will participate in two anti-SAP dosing sessions approximately 26 days in duration. The first two subjects in Part A will have up to three 89Zr PET scans, while the remaining subject will undergo up to two 89Zr PET scans.|Approximately 3 subjects with either wild type or inherited ATTR-CM will be included. Subjects in Part B will participate in one anti-SAP dosing session. Subjects will undergo up to two 89Zr PET scans.","Drug","GSK2315698 (CPHPC)|GSK2398852 (unlabeled anti-SAP mAb)|89Zr-GSK2398852 (89Zr-labeled anti-SAP mAb)","GSK2315698 will be administered as 20 milligrams per hour (20 mg/hour) IV infusion (in the vein) for up to 72 hours followed by 60 milligrams (mg) three times daily as SC injection for 8 days. Dose level and frequency will be adjusted according to renal function.|Subjects will be administered up to 490 mg of GSK2398852, IV. Dose level will be adjusted based on emerging imaging data.|89Zr-GSK2398852 will be available as solution containing 10 mg 89Zr-GSK2398852 for Infusion. Subjects will be administered 37 (Megabecquerel) MBq radioactive dose of 89Zr-GSK2398852 by the IV route at each dosing session.","miridesap|dezamizumab","Subjects with ATTR-CM in Part A|Subjects with ATTR-CM in Part B","\n\n * Subject must be 65 to 80 years of age inclusive, at the time of signing the informed consent.\n * Subjects with a diagnosis of ATTR-CM: a) Wild-type ATTR status must be confirmed by genotyping and have one of the following: i) Definite histochemical identification of amyloid by Congo red staining and green birefringence in crossed polarized light in cardiac or other tissue biopsy and identification of Transthyretin amyloidosis (TTR) as the amyloid fibril protein either by immunohistochemistry or proteomic analysis OR ii) Scintigraphy Technetium-99m-labeled 3,3-diphosphono-1,2-propanodicarboxylic acid (99mTc-DPD) with confirmed myocardial uptake. b) Hereditary ATTR amyloidosis (example, TTR Val30Met) should have a known amyloidogenic TTR mutation demonstrated by genotyping and is recognized to be primarily associated with cardiomyopathy and one of the following: i) Definite histochemical identification of amyloid by Congo red staining and green birefringence in crossed polarized light in cardiac or other tissue biopsy and identification of TTR as the amyloid fibril protein either by immunohistochemistry or proteomic analysis. ii) Scintigraphy: 99mTc-DPD with confirmed myocardial uptake.\n * Both male and female subjects are eligible to participate. a) Male subjects: A male subject must agree to use contraception during the treatment period and for at least 3 months after the last scan and refrain from donating sperm during this period. b) Female subjects: A female subject is eligible to participate if she is not of childbearing potential.\n * Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and protocol.\n * New York Heart Association (NYHA) up to class 3; subjects should be clinically stable for at least 3 months preceding to Screening.\n\n","\n\n * Cardiomyopathy primarily caused by non-amyloid diseases (example, ischemic heart disease; valvular heart disease).\n * Interval from the Q wave on the ECG to point T using Fredericia's formula (QTcF) >500 milliseconds (msec).\n * Sustained (at a rate of >=120 beats per minute for >=30 seconds), or symptomatic monomorphic ventricular tachycardia (VT), or rapid polymorphic VT, at Screening/Baseline cardiac monitoring.\n * Systolic blood pressure <=100 millimeters of mercury (mm/Hg) based on triplicate readings at Screening.\n * Unstable heart failure defined as emergency hospitalization for worsening, or decompensated heart failure, or syncopal episode within 1 month of screening.\n * Implantable cardiac defibrillator (ICD) or permanent pacemaker (PPM) at Screening.\n * Estimated Glomerular filtration rate (eGFR) at Screening <50 milliliters per minute (mL/min) calculated using modification of diet in renal disease (MDRD).\n * Any active and persistent dermatological condition, which in the opinion of the Investigator and Medical Monitor would preclude safe participation.\n * History of allogeneic stem cell transplantation, prior solid organ transplant, or anticipated to undergo solid organ transplantation, or left ventricular assist device (LVAD) implantation.\n * Malignancy within last 5 years, except for basal or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix that has been successfully treated.\n * Acute coronary syndrome, or any form of coronary revascularization procedure (including coronary artery bypass grafting [CABG]), within 6 months of screening.\n * Symptomatic, clinically significant autonomic neuropathy which the Principal Investigator (PI) feels will preclude administration of study treatment.\n * Uncontrolled hypertension during Screening.\n * ALT >3 times upper limit of normal (ULN) OR bilirubin >1.5 times ULN (isolated bilirubin >1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).\n * Peripheral edema at Screening that in the opinion of the PI or designee might prevent adequate absorption of subcutaneously administered CPHPC.\n * Presence of any co-morbid (example, steroid refractory rheumatoid arthritis), or an uncontrolled medical condition (example, diabetes mellitus), which in the opinion of the investigator would increase the potential risk to the subject. Investigator should liaise with the Medical Monitor where there is uncertainty as to the eligibility of a subject.\n * Positive test for hepatitis B, hepatitis C and/or human immunodeficiency virus (HIV) during Screening, or within 3 months prior to first dose of study treatment.\n * Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear immunoglobulin A [IgA] dermatosis, toxic epidermal necrolysis and exfoliative dermatitis).\n * Inability to comprehend and/or understand the study patient information sheet, and/or unwillingness or inability to follow the procedures outlined in the protocol.\n * Has any of the following: a) Fulfillment of diagnostic criteria for Amyloid Light-chain (AL) amyloidosis. b) Fulfillment of diagnostic criteria for amyloid A (AA) or non-TTR hereditary amyloidosis.\n * ATTR Disease Load: c) Histologically proven or clinically suspected gastrointestinal TTR amyloidosis; d) Diffuse skeletal muscle uptake of 99m(Tc)-DPD on Single-photon emission computed tomography (SPECT) imaging (where available); e) Peripheral neuropathy causing more than mild morbidity (example, walking disability; neuropathic pain affecting activities of daily living); f) Proven or clinically suspected intracranial TTR involvement including ophthalmological disease.\n * Non-amyloidosis related chronic liver disease (with the exception of Gilbert's syndrome or clinically asymptomatic gallstones).\n * Participation in a separate clinical trial involving CPHPC within 3 months of Screening.\n * Any prohibited concomitant medication within referenced timeframe.\n * Treatment with another investigational drug, biological agent, or device within 6 months of screening, or 5 half-lives of the study agent, whichever is longer.\n * Orthopnea of sufficient severity to preclude supine scanning as determined at Screening.\n * Inability to fit inside scanner due to body size (girth).\n * History of claustrophobia.\n * Contraindication to magnetic resonance imaging (MRI) contrast agents.\n * Contraindication for MRI scanning (as assessed by local MRI safety questionnaire), which includes but is not limited to: a) Intracranial aneurysm clips (except Sugita) or other metallic objects; b) Intra-orbital metal fragments that have not been removed; c) Pacemakers or other implanted cardiac rhythm management/monitoring devices and non-magnetic resonance (MR) conditional heart valves; d) Inner ear implants.\n * Donation of blood or blood products in excess of 500 milliliters (mL) within 84 days of Screening.\n * Poor or unsuitable venous access.","transthyretin",null,"Protein","Ovary","Actual","2018-01-31","Actual","Anticipated","2018-12-11","Anticipated","2018-05-01","2018-01-25","2018-01-25","2018-05-18","No","miridesap\nGSK2315698\n89Zirconium labelled\nPositron Emission Tomography\nTransthyretin cardiomyopathy\nGSK2398852\ndezamizumab","Interventional","Diagnostic","Sequential Assignment","None (Open Label)","Non-Randomized","65 Years","80 Years","All",null,"No","Yes\nIPD for this study will be made available via the Clinical Study Data Request site.",{"$nulls":3},"Yes","No",{"$nulls":19},"Standardized Uptake Values (SUV) in focal anatomical regions of the heart following 80-200 milligrams (mg) dose of anti-SAP mAb|SUV in focal anatomical regions of the heart following an anti-SAP mAb dose between 200 mg and <=500 mg|SUV of whole heart following 80-200 mg dose of anti-SAP mAb|SUV of whole heart following an anti-SAP mAb dose between 200 mg and <=500 mg","PET images will be visually reviewed to assess the radioactivity distribution. SUV is the measured radioactivity concentration corrected for radioactive decay and normalized for administered amount of radioactivity per body weight.","Up to Day 6","Focal radioactivity uptake after 80-200 mg dose of anti-SAP mAb|Focal radioactivity uptake after an anti-SAP mAb dose between 200 mg and <=500 mg|Total radioactivity uptake after 80-200 mg dose of anti-SAP mAb|Total radioactivity uptake after an anti-SAP mAb dose between 200 mg and <=500 mg|Maximum concentration in plasma (Cmax) of total mAb|Time associated with Cmax (Tmax) of total mAb|Clearance of total mAb|Terminal half-life (T1/2) of total mAb|Area under the concentration-time profile (AUC) of total mAb|Cmax of 89Zr- GSK2398852 pharmacokinetics of radioactivity (radio-PK)|Tmax of 89Zr- GSK2398852 radio-PK|T1/2 of 89Zr- GSK2398852 radio-PK|AUC of 89Zr- GSK2398852 radio-PK|Number of subjects with adverse events (AEs) and serious adverse events (SAEs)|Number of subjects with skin rashes|Number of subjects with cardiac adverse events|Number of subjects with infusion related reactions|Number of subjects with abnormal hematology parameters|Number of subjects with abnormal clinical chemistry parameters|Number of subjects with abnormal urine parameters|Number of subjects with cardiac safety parameters of clinical significance|Number of subjects with abnormal electrocardiogram (ECG)|Number of subjects with abnormal inpatient cardiac telemetry|Number of subjects with abnormal outpatient cardiac telemetry|Number of subjects with abnormal temperature|Number of subjects with abnormal blood pressure|Number of subjects with abnormal pulse rate|Number of subjects with abnormal respiratory rate|Number of subjects with abnormal physical examination findings","PET images will be visually reviewed to assess the radioactivity distribution. SUV is the measured radioactivity concentration corrected for radioactive decay and normalized for administered amount of radioactivity per body weight. Focal radioactivity uptake in different tissues will be evaluated.|PET images will be visually reviewed to assess the radioactivity distribution. SUV is the measured radioactivity concentration corrected for radioactive decay and normalized for administered amount of radioactivity per body weight. Total radioactivity uptake in different tissues will be evaluated.|Blood samples will be collected at indicated time points for measurement of plasma concentrations of GSK2398852. Plasma concentrations of GSK2398852, will be the total of both 89Zr-labeled and unlabeled mAb.|Blood samples will be collected at indicated time points for measurement of radioactivity. The radioactivity will reflect the total concentration of 89Zr-GSK2398852 and its radioactive metabolites. Plasma radioactive concentration will be measured by scintillation counter.|An AE is any untoward medical occurrence in a clinical study subject, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; other important medical events which may require medical or surgical intervention.|Rash will be graded as Grade 1 to Grade 4 based on symptoms and body surface area affected.|Cardiovascular adverse events will include myocardial infarction/unstable angina, congestive heart failure, arrhythmias, valvulopathy, pulmonary hypertension, cerebrovascular events/stroke and transient ischemic attack, peripheral arterial thromboembolism, deep venous thrombosis/pulmonary embolism and revascularization.|Number of subjects with infusion related reactions will be summarized.|The following hematology parameters will be assessed: platelet count, red blood cell (RBC) count, hemoglobin, hematocrit, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), percentage of reticulocytes, neutrophils, lymphocytes, monocytes, eosinophils and basophils.|The following clinical chemistry parameters will be evaluated: blood urea nitrogen (BUN), creatinine, glucose (non-fasting), potassium, sodium, calcium, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase, total and direct bilirubin, total protein and albumin.|The following parameters will be evaluated: specific gravity, potential hydrogen (pH), glucose, protein, blood and ketones by dipstick method. Urine microscopy will be performed if indicated.|The following cardiac chemistry parameters will be evaluated: troponin T and N-terminal prohormone of brain natriuretic peptide (NT-ProBNP).|12-lead ECGs will be obtained in a semi-supine position using an automated ECG machine after approximately 5 minutes of rest for the subject.|Inpatient cardiac monitoring will be performed using inpatient lead II cardiac telemetry.|Outpatient cardiac monitoring will be performed using a non-implantable remote cardiac telemetry device.|Temperature will be measured in a semi-supine position after 5 minutes of rest.|Systolic and diastolic blood pressure will be measured in a semi-supine position after 5 minutes of rest.|Pulse rate will be measured in a semi-supine position after 5 minutes of rest.|Respiratory rate will be measured in a semi-supine position after 5 minutes of rest.|A brief physical examination will be performed, including assessments of the skin, lungs, cardiovascular system and abdomen (liver and spleen).","Up to Day 6|Day 3 (pre-dose, 4 hours, 7 hours post-dose), Day 4, Day 5, Day 6 and Day 7 post-dose|Day 3 (10 minutes, 60 minutes, 4 hours, 7 hours post-dose), Day 4, Day 5 and Day 6 post-dose|Up to Day 28|Up to Day 11|Up to Day 18","GSKClinicalSupportHD@gsk.com","US GSK Clinical Trials Call Center","877-379-3718","Uppsala, Sweden, Se-751 85",null,"Sweden","Gsk Investigational Site",{"$nulls":3},"GSK Clinical Trials","2018-05-18","2020-05-25T16:39:52.591","2020-05-26T17:10:42.972","NCT03417830"]
["5ecbf4d9e2561b1b11905ede","NCT03417830","2018-12-12","GlaxoSmithKline","GSK","Terminated","Biodistribution of 89Zirconium-labelled GSK2398852 Using PET Imaging","Cphpc|Dezamizumab",null,"Yes","['Cphpc', 'Dezamizumab']","Unknown",null,"Phase 1",2,2,"Actual","2018-04-06","2018-07-20","SUV","Standardized Uptake Value",{"$nulls":3},"The principal aim of this study is to investigate the cardiac uptake of 89Zr-GSK2398852 in subjects with transthyretin cardiomyopathy amyloidosis (ATTR-CM), and its biodistribution to other organs. Low doses of GSK2398852 will be co-administered at levels not high enough for therapeutic benefit. This study will be conducted in two parts: Part A and Part B. Subjects in Part A will participate in up to two dosing sessions and subjects in Part B will participate in one dosing session. Subjects will undergo up to 3 PET scans at varying intervals after 89Zr-GSK2398852 administration. The total duration of study will be approximately 3 to 4 months for subjects in Part A and approximately 2 months for subjects in Part B. Part B of the study will be triggered based on data obtained in Part A and other emerging data.",null,"An Adaptive, Open-Label Study to Evaluate the Biodistribution of 89Zirconium-labelled GSK2398852 in the Heart and Other Organs of Patients With Transthyretin Cardiomyopathy (ATTR-CM) Using Positron Emission Tomography (PET) Imaging",204512,"Amyloidosis","Amyloidosis","Metabolic Diseases","Nutritional Disorders","Experimental","Subjects with ATTR-CM in Part A|Subjects with ATTR-CM in Part B","Approximately 3 subjects with either wild type or inherited ATTR-CM will be included. Subjects in Part A will participate in two anti-SAP dosing sessions approximately 26 days in duration. The first two subjects in Part A will have up to three 89Zr PET scans, while the remaining subject will undergo up to two 89Zr PET scans.|Approximately 3 subjects with either wild type or inherited ATTR-CM will be included. Subjects in Part B will participate in one anti-SAP dosing session. Subjects will undergo up to two 89Zr PET scans.","Drug","GSK2315698 (CPHPC)|GSK2398852 (unlabeled anti-SAP mAb)|89Zr-GSK2398852 (89Zr-labeled anti-SAP mAb)","GSK2315698 will be administered as 20 milligrams per hour (20 mg/hour) IV infusion (in the vein) for up to 72 hours followed by 60 milligrams (mg) three times daily as SC injection for 8 days. Dose level and frequency will be adjusted according to renal function.|Subjects will be administered up to 490 mg of GSK2398852, IV. Dose level will be adjusted based on emerging imaging data.|89Zr-GSK2398852 will be available as solution containing 10 mg 89Zr-GSK2398852 for Infusion. Subjects will be administered 37 (Megabecquerel) MBq radioactive dose of 89Zr-GSK2398852 by the IV route at each dosing session.","miridesap|dezamizumab","Subjects with ATTR-CM in Part A|Subjects with ATTR-CM in Part B","\n\n * Subject must be 65 to 80 years of age inclusive, at the time of signing the informed consent.\n * Subjects with a diagnosis of ATTR-CM: a) Wild-type ATTR status must be confirmed by genotyping and have one of the following: i) Definite histochemical identification of amyloid by Congo red staining and green birefringence in crossed polarized light in cardiac or other tissue biopsy and identification of Transthyretin amyloidosis (TTR) as the amyloid fibril protein either by immunohistochemistry or proteomic analysis OR ii) Scintigraphy Technetium-99m-labeled 3,3-diphosphono-1,2-propanodicarboxylic acid (99mTc-DPD) with confirmed myocardial uptake. b) Hereditary ATTR amyloidosis (example, TTR Val30Met) should have a known amyloidogenic TTR mutation demonstrated by genotyping and is recognized to be primarily associated with cardiomyopathy and one of the following: i) Definite histochemical identification of amyloid by Congo red staining and green birefringence in crossed polarized light in cardiac or other tissue biopsy and identification of TTR as the amyloid fibril protein either by immunohistochemistry or proteomic analysis. ii) Scintigraphy: 99mTc-DPD with confirmed myocardial uptake.\n * Both male and female subjects are eligible to participate. a) Male subjects: A male subject must agree to use contraception during the treatment period and for at least 3 months after the last scan and refrain from donating sperm during this period. b) Female subjects: A female subject is eligible to participate if she is not of childbearing potential.\n * Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and protocol.\n * New York Heart Association (NYHA) up to class 3; subjects should be clinically stable for at least 3 months preceding to Screening.\n\n","\n\n * Cardiomyopathy primarily caused by non-amyloid diseases (example, ischemic heart disease; valvular heart disease).\n * Interval from the Q wave on the ECG to point T using Fredericia's formula (QTcF) >500 milliseconds (msec).\n * Sustained (at a rate of >=120 beats per minute for >=30 seconds), or symptomatic monomorphic ventricular tachycardia (VT), or rapid polymorphic VT, at Screening/Baseline cardiac monitoring.\n * Systolic blood pressure <=100 millimeters of mercury (mm/Hg) based on triplicate readings at Screening.\n * Unstable heart failure defined as emergency hospitalization for worsening, or decompensated heart failure, or syncopal episode within 1 month of screening.\n * Implantable cardiac defibrillator (ICD) or permanent pacemaker (PPM) at Screening.\n * Estimated Glomerular filtration rate (eGFR) at Screening <50 milliliters per minute (mL/min) calculated using modification of diet in renal disease (MDRD).\n * Any active and persistent dermatological condition, which in the opinion of the Investigator and Medical Monitor would preclude safe participation.\n * History of allogeneic stem cell transplantation, prior solid organ transplant, or anticipated to undergo solid organ transplantation, or left ventricular assist device (LVAD) implantation.\n * Malignancy within last 5 years, except for basal or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix that has been successfully treated.\n * Acute coronary syndrome, or any form of coronary revascularization procedure (including coronary artery bypass grafting [CABG]), within 6 months of screening.\n * Symptomatic, clinically significant autonomic neuropathy which the Principal Investigator (PI) feels will preclude administration of study treatment.\n * Uncontrolled hypertension during Screening.\n * ALT >3 times upper limit of normal (ULN) OR bilirubin >1.5 times ULN (isolated bilirubin >1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).\n * Peripheral edema at Screening that in the opinion of the PI or designee might prevent adequate absorption of subcutaneously administered CPHPC.\n * Presence of any co-morbid (example, steroid refractory rheumatoid arthritis), or an uncontrolled medical condition (example, diabetes mellitus), which in the opinion of the investigator would increase the potential risk to the subject. Investigator should liaise with the Medical Monitor where there is uncertainty as to the eligibility of a subject.\n * Positive test for hepatitis B, hepatitis C and/or human immunodeficiency virus (HIV) during Screening, or within 3 months prior to first dose of study treatment.\n * Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear immunoglobulin A [IgA] dermatosis, toxic epidermal necrolysis and exfoliative dermatitis).\n * Inability to comprehend and/or understand the study patient information sheet, and/or unwillingness or inability to follow the procedures outlined in the protocol.\n * Has any of the following: a) Fulfillment of diagnostic criteria for Amyloid Light-chain (AL) amyloidosis. b) Fulfillment of diagnostic criteria for amyloid A (AA) or non-TTR hereditary amyloidosis.\n * ATTR Disease Load: c) Histologically proven or clinically suspected gastrointestinal TTR amyloidosis; d) Diffuse skeletal muscle uptake of 99m(Tc)-DPD on Single-photon emission computed tomography (SPECT) imaging (where available); e) Peripheral neuropathy causing more than mild morbidity (example, walking disability; neuropathic pain affecting activities of daily living); f) Proven or clinically suspected intracranial TTR involvement including ophthalmological disease.\n * Non-amyloidosis related chronic liver disease (with the exception of Gilbert's syndrome or clinically asymptomatic gallstones).\n * Participation in a separate clinical trial involving CPHPC within 3 months of Screening.\n * Any prohibited concomitant medication within referenced timeframe.\n * Treatment with another investigational drug, biological agent, or device within 6 months of screening, or 5 half-lives of the study agent, whichever is longer.\n * Orthopnea of sufficient severity to preclude supine scanning as determined at Screening.\n * Inability to fit inside scanner due to body size (girth).\n * History of claustrophobia.\n * Contraindication to magnetic resonance imaging (MRI) contrast agents.\n * Contraindication for MRI scanning (as assessed by local MRI safety questionnaire), which includes but is not limited to: a) Intracranial aneurysm clips (except Sugita) or other metallic objects; b) Intra-orbital metal fragments that have not been removed; c) Pacemakers or other implanted cardiac rhythm management/monitoring devices and non-magnetic resonance (MR) conditional heart valves; d) Inner ear implants.\n * Donation of blood or blood products in excess of 500 milliliters (mL) within 84 days of Screening.\n * Poor or unsuitable venous access.","transthyretin",null,"Protein","Ovary","Actual","2018-01-31","Actual","Actual","2018-07-20","Actual","2018-12-01","2018-01-25","2018-01-25","2018-12-10","No","miridesap\nGSK2315698\n89Zirconium labelled\nPositron Emission Tomography\nTransthyretin cardiomyopathy\nGSK2398852\ndezamizumab","Interventional","Diagnostic","Sequential Assignment","None (Open Label)","Non-Randomized","65 Years","80 Years","All",null,"No","Yes\nIPD for this study will be made available via the Clinical Study Data Request site.",{"$nulls":3},"Yes","No",{"$nulls":17},"2017-002665-22","EudraCT Number","Standardized Uptake Values (SUV) in focal anatomical regions of the heart following 80-200 milligrams (mg) dose of anti-SAP mAb|SUV in focal anatomical regions of the heart following an anti-SAP mAb dose between 200 mg and <=500 mg|SUV of whole heart following 80-200 mg dose of anti-SAP mAb|SUV of whole heart following an anti-SAP mAb dose between 200 mg and <=500 mg","PET images will be visually reviewed to assess the radioactivity distribution. SUV is the measured radioactivity concentration corrected for radioactive decay and normalized for administered amount of radioactivity per body weight.","Up to Day 6","Focal radioactivity uptake after 80-200 mg dose of anti-SAP mAb|Focal radioactivity uptake after an anti-SAP mAb dose between 200 mg and <=500 mg|Total radioactivity uptake after 80-200 mg dose of anti-SAP mAb|Total radioactivity uptake after an anti-SAP mAb dose between 200 mg and <=500 mg|Maximum concentration in plasma (Cmax) of total mAb|Time associated with Cmax (Tmax) of total mAb|Clearance of total mAb|Terminal half-life (T1/2) of total mAb|Area under the concentration-time profile (AUC) of total mAb|Cmax of 89Zr- GSK2398852 pharmacokinetics of radioactivity (radio-PK)|Tmax of 89Zr- GSK2398852 radio-PK|T1/2 of 89Zr- GSK2398852 radio-PK|AUC of 89Zr- GSK2398852 radio-PK|Number of subjects with adverse events (AEs) and serious adverse events (SAEs)|Number of subjects with skin rashes|Number of subjects with cardiac adverse events|Number of subjects with infusion related reactions|Number of subjects with abnormal hematology parameters|Number of subjects with abnormal clinical chemistry parameters|Number of subjects with abnormal urine parameters|Number of subjects with cardiac safety parameters of clinical significance|Number of subjects with abnormal electrocardiogram (ECG)|Number of subjects with abnormal inpatient cardiac telemetry|Number of subjects with abnormal outpatient cardiac telemetry|Number of subjects with abnormal temperature|Number of subjects with abnormal blood pressure|Number of subjects with abnormal pulse rate|Number of subjects with abnormal respiratory rate|Number of subjects with abnormal physical examination findings","PET images will be visually reviewed to assess the radioactivity distribution. SUV is the measured radioactivity concentration corrected for radioactive decay and normalized for administered amount of radioactivity per body weight. Focal radioactivity uptake in different tissues will be evaluated.|PET images will be visually reviewed to assess the radioactivity distribution. SUV is the measured radioactivity concentration corrected for radioactive decay and normalized for administered amount of radioactivity per body weight. Total radioactivity uptake in different tissues will be evaluated.|Blood samples will be collected at indicated time points for measurement of plasma concentrations of GSK2398852. Plasma concentrations of GSK2398852, will be the total of both 89Zr-labeled and unlabeled mAb.|Blood samples will be collected at indicated time points for measurement of radioactivity. The radioactivity will reflect the total concentration of 89Zr-GSK2398852 and its radioactive metabolites. Plasma radioactive concentration will be measured by scintillation counter.|An AE is any untoward medical occurrence in a clinical study subject, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; other important medical events which may require medical or surgical intervention.|Rash will be graded as Grade 1 to Grade 4 based on symptoms and body surface area affected.|Cardiovascular adverse events will include myocardial infarction/unstable angina, congestive heart failure, arrhythmias, valvulopathy, pulmonary hypertension, cerebrovascular events/stroke and transient ischemic attack, peripheral arterial thromboembolism, deep venous thrombosis/pulmonary embolism and revascularization.|Number of subjects with infusion related reactions will be summarized.|The following hematology parameters will be assessed: platelet count, red blood cell (RBC) count, hemoglobin, hematocrit, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), percentage of reticulocytes, neutrophils, lymphocytes, monocytes, eosinophils and basophils.|The following clinical chemistry parameters will be evaluated: blood urea nitrogen (BUN), creatinine, glucose (non-fasting), potassium, sodium, calcium, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase, total and direct bilirubin, total protein and albumin.|The following parameters will be evaluated: specific gravity, potential hydrogen (pH), glucose, protein, blood and ketones by dipstick method. Urine microscopy will be performed if indicated.|The following cardiac chemistry parameters will be evaluated: troponin T and N-terminal prohormone of brain natriuretic peptide (NT-ProBNP).|12-lead ECGs will be obtained in a semi-supine position using an automated ECG machine after approximately 5 minutes of rest for the subject.|Inpatient cardiac monitoring will be performed using inpatient lead II cardiac telemetry.|Outpatient cardiac monitoring will be performed using a non-implantable remote cardiac telemetry device.|Temperature will be measured in a semi-supine position after 5 minutes of rest.|Systolic and diastolic blood pressure will be measured in a semi-supine position after 5 minutes of rest.|Pulse rate will be measured in a semi-supine position after 5 minutes of rest.|Respiratory rate will be measured in a semi-supine position after 5 minutes of rest.|A brief physical examination will be performed, including assessments of the skin, lungs, cardiovascular system and abdomen (liver and spleen).","Up to Day 6|Day 3 (pre-dose, 4 hours, 7 hours post-dose), Day 4, Day 5, Day 6 and Day 7 post-dose|Day 3 (10 minutes, 60 minutes, 4 hours, 7 hours post-dose), Day 4, Day 5 and Day 6 post-dose|Up to Day 28|Up to Day 11|Up to Day 18",{"$nulls":3},"Uppsala, Sweden, Se-751 85 Gsk Investigational SiteUppsala, Sweden, Se-751",null,"Sweden","Gsk Investigational Site",{"$nulls":3},"GSK Clinical Trials","2018-12-10","2020-05-25T16:39:53.057","2020-05-26T17:10:42.972","NCT03417830"]
["5ecbf4d911702c1b1b916bf1","NCT03417830","2019-08-29","GlaxoSmithKline","GSK","Terminated","Biodistribution of 89Zirconium-labelled GSK2398852 Using PET Imaging","Cphpc|Dezamizumab",null,"Yes","['Cphpc', 'Dezamizumab']","Unknown",null,"Phase 1",2,2,"Actual","2018-04-06","2018-07-20",{"$nulls":5},"The principal aim of this study is to investigate the cardiac uptake of 89Zr-GSK2398852 in subjects with transthyretin cardiomyopathy amyloidosis (ATTR-CM), and its biodistribution to other organs. Low doses of GSK2398852 will be co-administered at levels not high enough for therapeutic benefit. This study will be conducted in two parts: Part A and Part B. Subjects in Part A will participate in up to two dosing sessions and subjects in Part B will participate in one dosing session. Subjects will undergo up to 3 PET scans at varying intervals after 89Zr-GSK2398852 administration. The total duration of study will be approximately 3 to 4 months for subjects in Part A and approximately 2 months for subjects in Part B. Part B of the study will be triggered based on data obtained in Part A and other emerging data.",null,"An Adaptive, Open-Label Study to Evaluate the Biodistribution of 89Zirconium-labelled GSK2398852 in the Heart and Other Organs of Patients With Transthyretin Cardiomyopathy (ATTR-CM) Using Positron Emission Tomography (PET) Imaging",204512,"Amyloidosis","Amyloidosis","Metabolic Diseases","Nutritional Disorders","Experimental","Subjects with ATTR-CM in Part A|Subjects with ATTR-CM in Part B","Approximately 3 subjects with either wild type or inherited ATTR-CM will be included. Subjects in Part A will participate in two anti-SAP dosing sessions approximately 26 days in duration. The first two subjects in Part A will have up to three 89Zr PET scans, while the remaining subject will undergo up to two 89Zr PET scans.|Approximately 3 subjects with either wild type or inherited ATTR-CM will be included. Subjects in Part B will participate in one anti-SAP dosing session. Subjects will undergo up to two 89Zr PET scans.","Drug","GSK2315698 (CPHPC)|GSK2398852 (unlabeled anti-SAP mAb)|89Zr-GSK2398852 (89Zr-labeled anti-SAP mAb)","GSK2315698 will be administered as 20 milligrams per hour (20 mg/hour) IV infusion (in the vein) for up to 72 hours followed by 60 milligrams (mg) three times daily as SC injection for 8 days. Dose level and frequency will be adjusted according to renal function.|Subjects will be administered up to 490 mg of GSK2398852, IV. Dose level will be adjusted based on emerging imaging data.|89Zr-GSK2398852 will be available as solution containing 10 mg 89Zr-GSK2398852 for Infusion. Subjects will be administered 37 (Megabecquerel) MBq radioactive dose of 89Zr-GSK2398852 by the IV route at each dosing session.","miridesap|dezamizumab","Subjects with ATTR-CM in Part A|Subjects with ATTR-CM in Part B","\n\n * Subject must be 65 to 80 years of age inclusive, at the time of signing the informed consent.\n * Subjects with a diagnosis of ATTR-CM: a) Wild-type ATTR status must be confirmed by genotyping and have one of the following: i) Definite histochemical identification of amyloid by Congo red staining and green birefringence in crossed polarized light in cardiac or other tissue biopsy and identification of Transthyretin amyloidosis (TTR) as the amyloid fibril protein either by immunohistochemistry or proteomic analysis OR ii) Scintigraphy Technetium-99m-labeled 3,3-diphosphono-1,2-propanodicarboxylic acid (99mTc-DPD) with confirmed myocardial uptake. b) Hereditary ATTR amyloidosis (example, TTR Val30Met) should have a known amyloidogenic TTR mutation demonstrated by genotyping and is recognized to be primarily associated with cardiomyopathy and one of the following: i) Definite histochemical identification of amyloid by Congo red staining and green birefringence in crossed polarized light in cardiac or other tissue biopsy and identification of TTR as the amyloid fibril protein either by immunohistochemistry or proteomic analysis. ii) Scintigraphy: 99mTc-DPD with confirmed myocardial uptake.\n * Both male and female subjects are eligible to participate. a) Male subjects: A male subject must agree to use contraception during the treatment period and for at least 3 months after the last scan and refrain from donating sperm during this period. b) Female subjects: A female subject is eligible to participate if she is not of childbearing potential.\n * Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and protocol.\n * New York Heart Association (NYHA) up to class 3; subjects should be clinically stable for at least 3 months preceding to Screening.\n\n","\n\n * Cardiomyopathy primarily caused by non-amyloid diseases (example, ischemic heart disease; valvular heart disease).\n * Interval from the Q wave on the ECG to point T using Fredericia's formula (QTcF) >500 milliseconds (msec).\n * Sustained (at a rate of >=120 beats per minute for >=30 seconds), or symptomatic monomorphic ventricular tachycardia (VT), or rapid polymorphic VT, at Screening/Baseline cardiac monitoring.\n * Systolic blood pressure <=100 millimeters of mercury (mm/Hg) based on triplicate readings at Screening.\n * Unstable heart failure defined as emergency hospitalization for worsening, or decompensated heart failure, or syncopal episode within 1 month of screening.\n * Implantable cardiac defibrillator (ICD) or permanent pacemaker (PPM) at Screening.\n * Estimated Glomerular filtration rate (eGFR) at Screening <50 milliliters per minute (mL/min) calculated using modification of diet in renal disease (MDRD).\n * Any active and persistent dermatological condition, which in the opinion of the Investigator and Medical Monitor would preclude safe participation.\n * History of allogeneic stem cell transplantation, prior solid organ transplant, or anticipated to undergo solid organ transplantation, or left ventricular assist device (LVAD) implantation.\n * Malignancy within last 5 years, except for basal or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix that has been successfully treated.\n * Acute coronary syndrome, or any form of coronary revascularization procedure (including coronary artery bypass grafting [CABG]), within 6 months of screening.\n * Symptomatic, clinically significant autonomic neuropathy which the Principal Investigator (PI) feels will preclude administration of study treatment.\n * Uncontrolled hypertension during Screening.\n * ALT >3 times upper limit of normal (ULN) OR bilirubin >1.5 times ULN (isolated bilirubin >1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).\n * Peripheral edema at Screening that in the opinion of the PI or designee might prevent adequate absorption of subcutaneously administered CPHPC.\n * Presence of any co-morbid (example, steroid refractory rheumatoid arthritis), or an uncontrolled medical condition (example, diabetes mellitus), which in the opinion of the investigator would increase the potential risk to the subject. Investigator should liaise with the Medical Monitor where there is uncertainty as to the eligibility of a subject.\n * Positive test for hepatitis B, hepatitis C and/or human immunodeficiency virus (HIV) during Screening, or within 3 months prior to first dose of study treatment.\n * Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear immunoglobulin A [IgA] dermatosis, toxic epidermal necrolysis and exfoliative dermatitis).\n * Inability to comprehend and/or understand the study patient information sheet, and/or unwillingness or inability to follow the procedures outlined in the protocol.\n * Has any of the following: a) Fulfillment of diagnostic criteria for Amyloid Light-chain (AL) amyloidosis. b) Fulfillment of diagnostic criteria for amyloid A (AA) or non-TTR hereditary amyloidosis.\n * ATTR Disease Load: c) Histologically proven or clinically suspected gastrointestinal TTR amyloidosis; d) Diffuse skeletal muscle uptake of 99m(Tc)-DPD on Single-photon emission computed tomography (SPECT) imaging (where available); e) Peripheral neuropathy causing more than mild morbidity (example, walking disability; neuropathic pain affecting activities of daily living); f) Proven or clinically suspected intracranial TTR involvement including ophthalmological disease.\n * Non-amyloidosis related chronic liver disease (with the exception of Gilbert's syndrome or clinically asymptomatic gallstones).\n * Participation in a separate clinical trial involving CPHPC within 3 months of Screening.\n * Any prohibited concomitant medication within referenced timeframe.\n * Treatment with another investigational drug, biological agent, or device within 6 months of screening, or 5 half-lives of the study agent, whichever is longer.\n * Orthopnea of sufficient severity to preclude supine scanning as determined at Screening.\n * Inability to fit inside scanner due to body size (girth).\n * History of claustrophobia.\n * Contraindication to magnetic resonance imaging (MRI) contrast agents.\n * Contraindication for MRI scanning (as assessed by local MRI safety questionnaire), which includes but is not limited to: a) Intracranial aneurysm clips (except Sugita) or other metallic objects; b) Intra-orbital metal fragments that have not been removed; c) Pacemakers or other implanted cardiac rhythm management/monitoring devices and non-magnetic resonance (MR) conditional heart valves; d) Inner ear implants.\n * Donation of blood or blood products in excess of 500 milliliters (mL) within 84 days of Screening.\n * Poor or unsuitable venous access.","transthyretin",null,"Protein","Ovary","Actual","2018-01-31","Actual","Actual","2018-07-20","Actual","2019-07-01","2018-01-25","2018-01-25","2019-07-16","No","miridesap\nGSK2315698\n89Zirconium labelled\nPositron Emission Tomography\nTransthyretin cardiomyopathy\nGSK2398852\ndezamizumab","Interventional","Diagnostic","Sequential Assignment","None (Open Label)","Non-Randomized","65 Years","80 Years","All",null,"No","Yes\nIPD for this study will be made available via the Clinical Study Data Request site.",{"$nulls":3},"Yes","No","2019-07-16","2019-07-16","2019-08-29","Actual",{"$nulls":13},"2017-002665-22","EudraCT Number",{"$nulls":9},"Uppsala, Sweden, Se-751 85",null,"Sweden","Gsk Investigational Site",{"$nulls":3},"GSK Clinical Trials","2019-07-16","2020-05-25T16:39:53.301","2020-05-26T17:10:42.972","NCT03417830"]
["5ecbf4dbfeab101b15530a18","NCT03418116","2019-06-25","Second Sight Medical Products","EYES","Withdrawn","Argus II Retinal Prosthesis System - Better Vision RP Study","All-trans-retinal",null,"No",null,"Unknown",null,"Not Applicable",1,0,"Actual","2018-11-01","2021-11-01",{"$nulls":5},"The study is conducted to evaluate the safety and benefit of the Argus II System in a selected patient population with advanced Retinitis Pigmentosa who have a measurable central residual visual field smaller than or equal to 5 degrees radius.","The Argus II System is intended for use in blind patients with severe to profound retinitis pigmentosa with at least some light perception in the eye to be implanted.\n\nThe majority of RP patients still have some central vision even at a very late stage of the disease. This extremely restricted visual field is, however, highly disabling in daily life. The primary objective of this study is to evaluate the safety and benefit of the Argus II System in RP patients characterized as late stage with a central residual visual field smaller than or equal to 5 degrees radius . The electrode array will be placed in a para- to peri foveal location adjacent to the subject's residual visual field, thus increasing the total retinal area receptive to light.\n\nSafety data will be monitored to ensure continued acceptability of risks to study subjects and visual function will be measured to evaluate the effectiveness of the system in this \"better vision\" RP population. In addition, effects on functional vision and quality of life will be assessed through the Functional Low-Vision Observer Rated Assessment (FLORA) and the National Eye Institute Visual Function Questionnaire (NEI-VFQ-25).","Argus II Retinal Prosthesis System - Better Vision RP Study","CP-08-01","Retinitis Pigmentosa","Retinitis Pigmentosa|Retinitis","Eye Diseases, Hereditary|Retinal Diseases","Ophthalmological","Experimental","Argus II","Implantation of the Argus II Retinal Prosthesis in patients with advanced Retinitis Pigmentosa who have a measurable central residual visual field smaller than or equal to 5 degrees radius. The array will be placed parafoveally, adjacent to the preserved central visual field (i.e., \"tunnel vision\") in these subjects.","Device","Argus II Retinal Prosthesis","The Argus II System is designed to provide visual function to individuals with severe to profound vision loss due to outer retinal degeneration. It consists of implanted and external components. The implant is an epiretinal prosthesis that is surgically implanted in and around the eye. The external equipment includes glasses and a video processing unit (VPU). The glasses include a miniature video camera, which captures video images, and a coil that sends data and stimulation commands to the implant. The VPU converts the video images into stimulation commands and is body-worn. The Argus II System operates by converting video images into electrical energy that activates retinal cells, delivering the signal through the optic nerve to the brain where it is perceived as light.",null,"Argus II","\n\n * Adults, age 25 years or older;\n * Diagnosed with advanced Retinitis Pigmentosa (including syndromic RP), Choroideremia, Leber's Congenital Amaurosis, or Rod-Cone disease;\n * A measurable central residual visual field of 5Â° radius or smaller in both eyes, as determined by Goldmann perimetry;\n * Visual acuity of 0.1 (1.0 logMAR) or worse in the eye to be implanted, as measured by ETDRS chart;\n * Previous history of useful form vision;\n * Provided written, informed consent to participate in the study.\n\n","\n\n * Ocular diseases or conditions that could prevent the Argus II implant from working (e.g., optic nerve disease, central retinal artery or vein occlusion, history of retinal detachment, trauma, etc.);\n * Ocular structures or conditions that could prevent the successful implantation of the Argus II Implant or adequate healing from surgery (e.g. extremely thin conjunctiva; axial length <20.5 mm or > 26 mm; corneal ulcers; choroidal neovascularization in the area of the intended tack location, etc.);\n * Pre-disposition to eye rubbing;\n * Any disease or condition that prevents understanding or communication of informed consent, study demands, and testing protocols, including: 1. cognitive decline including diagnosed forms of dementia and/or progressive neurologic disease,\n    2. psychiatric disease including diagnosed forms of depression;\n    3. does not speak a principal language associated with the region, and\n    4. deafness or selective frequency hearing loss that prevents hearing device alarms and alerts;\n   \n   \n * Pregnant or wish to become pregnant during the course of the study;\n * Participating in another investigational drug or device study that may conflict with the objectives, follow-up, or testing of this study;\n * Inability to tolerate general anaesthesia or the recommended antibiotic and steroid regimen associated with the implantation surgery;\n * Conditions likely to limit life to less than 1 year from the time of inclusion.",{"$nulls":4},"Actual","2018-02-01","Actual","Anticipated","2021-11-01","Anticipated","2019-06-01","2018-01-25","2018-01-25","2019-06-21","Yes",null,"Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","25 Years",null,"All",null,"No",{"$nulls":4},"No","Yes",{"$nulls":4},"Yes",{"$nulls":14},"Adverse events|Visual field","The nature and number of adverse events in implanted subjects.|The effect of the Argus II System on visual field size, as measured by Goldmann perimetry","2 Years","Visual function|Quality of Life|Functional vision and quality of life","Effect of the Argus II System on visual function, as measured by a suite of visual tests|Effect of the Argus II System on quality of life, as measured by the National Eye Institute Visual Function Questionnaire (NEI-VFQ-25)|The general impact of the Argus II on subject's lives, as measured by the Functional Low-Vision Observer Rated Assessment (FLORA)","2 Years",{"$nulls":3},"Karlsruhe, Baden-Wurttemberg, Germany, 76133|Aachen, Germany, 52074|LÃ¼beck, Schleswig-Holstein, Germany, 23538",null,"Germany","Baden-Wurttemberg Augenklinik StÃ¤dtisches Klinikum Karlsruhe|Rwth University Eye Clinic|Schleswig-Holstein University Medical Center Schleswig-Holstein, Department Of Ophthalmology",{"$nulls":4},"2019-06-21","2020-05-25T16:39:55.291","2020-05-26T17:10:42.972","NCT03418116"]
["5ecbf4dd11702c1b1b916bfa","NCT03418168","2018-02-01","Bayer","BAYN","Not yet recruiting","A Study of Molidustat for Treatment of Renal Anemia in Peritoneal Dialysis Subjects (MIYABI PD)","Molidustat","HIF Inhibitor","Yes","['Molidustat']","Yes","['HIF Inhibitor']","Phase 3",1,50,"Anticipated","2018-02-05","2019-10-05",{"$nulls":5},"The purpose of this study is to evaluate the efficacy and safety of molidustat in peritoneal dialysis subjects with renal anemia",null,"An Open-label, Multicenter Study to Investigate the Efficacy and Safety of Oral Molidustat in Peritoneal Dialysis Subjects With Renal Anemia",19353,"Anemia and Renal Insufficiency, Chronic","Anemia|Renal Insufficiency|Renal Insufficiency, Chronic","Hematologic Diseases|Urologic Diseases","Heme & Lymph Diseases|Reproductive and Urogenital","Experimental","Molidustat (BAY85-3934)","Molidustat group","Drug","Molidustat (BAY85-3934)","Starting dose of molidustat once daily (OD) will be titrated based on the subject's Hb (Hemoglobin) response",null,"Molidustat (BAY85-3934)","\n\n * Subject with end-stage kidney disease (ESKD) on peritoneal dialysis prior to assignment and not expected to start maintenance dialysis (e.g., hemodialysis, hemodiafiltration) other than peritoneal dialysis during the study period\n * Body weight > 40 and â‰¤ 160 kg at screening\n * Male or female subject â‰¥ 20 years of age at screening\n * At least one kidney\n * Subjects who meet one of the 1 or 2 following criteria * Subjects untreated with ESA at assignment: Mean of the last 2 Hb level (central laboratory measurement) during the screening period must be â‰¥ 8.0 and < 11.0 g/dL (2 measurements must be taken â‰¥ 2 days apart and the difference between the 2 measurements must be < 1.2 g/dL) with the last screening Hb measurement within 14 days prior to study drug assignment\n    * Subjects pre treated with ESA at assignment: Mean of the last 2 Hb level (central laboratory measurement) during the screening period must be â‰¥ 10.0 and < 13.0 g/dL (2 measurements must be taken â‰¥ 2 days apart and the difference between the 2 measurements must be < 1.2 g/dL) with the last screening Hb measurement within 14 days prior to study drug assignment\n   \n   \n * Subjects who meet one of the 1 or 2 following criteria * Subjects untreated with ESA at assignment: Subject with ESKD on peritoneal dialysis for at least 2 weeks prior to assignment. AND. Subject not received ESA for 8 weeks prior to assignment. OR. In case of the patient washed out from ESAs, when mean of the last 2 Hb level (at least 2 central laboratory measurements must be taken â‰¥ 2 days apart) has decrease to â‰¥ 0.5g/dL from the Hb level (central laboratory measurement) after the last ESA administration, AND the interval from the last ESA administration to the study drug assignment should be over 2 week for epoetin-alpha/beta, 4 weeks for darbepoetin alpha or epoetin beta pegol\n    * Subjects pre treated with ESA at assignment: * Subject with ESKD on peritoneal dialysis for at least 12 weeks prior to assignment\n       * Subject treated with ESA by IV or SC within 8 weeks prior to assignment\n       * Treated with 2 or 4 weekly dose of darbepoetin alfa, 4 weekly dose of epoetin beta pegol, OR 3 times per week, twice per week, weekly or bi-weekly dose of epoetin alfa/beta, and having had no more than one dose change within 8 weeks prior to assignment\n      \n      \n   \n   \n\n","\n\n * New York Heart Association (NYHA) Class III or IV congestive heart failure\n * History of cardio- (cerebro-) vascular events (e.g., unstable angina, myocardial infarction, stroke, pulmonary thromboembolism, and acute limb ischemia) within 6 months prior to randomization\n * Sustained and poorly controlled arterial hypertension (defined as systolic BPâ‰¥ 180mmHg or diastolic BP â‰¥ 110mmHg) or hypotension (defined as systolic BP < 90mmHg) at randomization\n * Proliferative choroidal or retinal disease, such as neovascular age-related macular degeneration or proliferative diabetic retinopathy requiring invasive treatment (e.g., intraocular injections or laser photocoagulation)",{"$nulls":4},"Actual","2018-02-01","Actual","Anticipated","2019-11-09","Anticipated","2018-01-01","2018-01-26","2018-01-26","2018-01-26","Yes",null,"Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","20 Years",null,"All",null,"No",{"$nulls":4},"No","No",{"$nulls":19},"Responder rate: proportion of responders among the subjects","Responder is defined as meeting all of the following criteria:\n\n(i) Mean of the Hb levels in the target range (ii) â‰¥ 50% of the Hb levels in the target range (iii) No rescue treatment","Week 30 to 36","Mean Hb (Hemoglobin) level|Change in mean Hb level|Rate of rise in Hb (Hemoglobin) level (g/dL/week)|Proportion of subjects who meet each component of the response|Hb level|Change in Hb level|Proportion of subjects with mean hemoglobin levels are in the target range|Proportion of subjects with mean hemoglobin levels are above the target range|Proportion of subjects with mean hemoglobin levels are below the target range|Proportion of subjects with hemoglobin levels in the target range|Proportion of subjects with hemoglobin levels above the target range|Proportion of subjects with hemoglobin levels below the target range|Proportion of subjects whose maximum rise in Hb between each consecutive visits is above 0.5 g/dL/week|Percentage of days in the target Hb range during the evaluation period|Percentage of days in the target Hb range during the treatment period|Rate of rise in Hb level (g/dL/week) between each consecutive visits|Percentage of Hb levels in target range during the evaluation period|Percentage of Hb levels in target range during the treatment period|Proportion of subjects who received at least one rescue treatment|Number of participants with serious adverse events|Maximum concentration (Cmax) of Molidustat|Area under the concentration-time curve (AUC) of Molidustat|EPO (Erythropoietin) serum concentration of Molidustat","Week 30 to 36|Baseline and Week 30 to 36|Up to 8 weeks|Up to 4 weeks|Response:\n\n(i) Mean of the Hb levels in the target range (ii) â‰¥ 50% of the Hb levels in the target range (iii) No rescue treatment|Baseline and Up to Week 36|Up to 36 weeks|Defined as change in Hb level / duration between two visits (weeks)|Defined as the number of measurements in the target range / number of measurements x 100|Baseline, Week 8, Wee16 and Week 36","Week 30 to 36|Up to 36 weeks|%)",{"$nulls":3},"Yatomi, Aichi, Japan, 498-8502|Matsuyama, Ehime, Japan, 790-0024|Fukui, Japan, 918-8503 Kyushu University HospitalFukuoka, Japan, 812-8582 Fukuoka University HospitalFukuoka, Japan, 814-0180 Japanese Red Cross Fukuoka HospitalFukuoka, Japan, 815-8555 Fukushima Medical University HospitalFukushima, Japan, 960-1295 Murakami Memorial Hospital Asahi UniversityGifu, Japan, 500-8523 National Hospital Organization Kyoto Medical CenterKyoto, Japan, 612-8555 Nara Prefecture General Medical CenterNara, Japan, 631-0846 Niigata City General HospitalNiigata, Japan, 950-1197 Japanese Red Cross Oita HospitalOita, Japan, 870-0033 Osaka General Medical CenterOsaka, Japan, 558-8558|Kitakyushu, Fukuoka, Japan, 802-8555 Jcho Kyusyu HospitalKitakyushu, Fukuoka, Japan, 806-8501 Kurume University HospitalKurume, Fukuoka, Japan, 830-0011|Sapporo, Hokkaido, Japan, 003-0814|Kobe, Hyogo, Japan, 650-0047|Fujisawa, Kanagawa, Japan, 251-8550 Shonan Kamakura General HospitalKamakura, Kanagawa, Japan, 247-8533 Toranomon Hospital KajigayaKawasaki, Kanagawa, Japan, 213-8587 Showa University Fujigaoka HospitalYokohama, Kanagawa, Japan, 227-8501|Sendai, Miyagi, Japan, 983-8512|Shibata, Niigata, Japan, 957-8588|Beppu, Oita, Japan, 874-0011|Uruma, Okinawa, Japan, 902-2293|Izumi, Osaka, Japan, 594-0076",null,"Japan","Aichi Kainan Hospital|Ehime Ehime Prefectural Central Hospital|Fukui-Ken Saiseikai Hospital|Fukuoka Kokura Memorial Hospital|Hokkaido Elm Grove Clinic|Hyogo Kobe City Medical Center General Hospital|Kanagawa Fujisawa City Hospital|Miyagi Tohoku Medical And Pharmaceutical University Hospital|Niigata Niigata Prefectural Shibata Hospital|Oita National Hospital Organization Beppu Medical Center|Okinawa Okinawa Prefectural Chubu Hospital|Osaka Fuchu Hospital",{"$nulls":4},"2018-01-26","2020-05-25T16:39:57.166","2020-05-26T17:10:42.972","NCT03418168"]
["5ecbf4dd11702c1b1b916bfc","NCT03418168","2018-05-30","Bayer","BAYN","Recruiting","A Study of Molidustat for Treatment of Renal Anemia in Peritoneal Dialysis Subjects (MIYABI PD)","Molidustat","HIF Inhibitor","Yes","['Molidustat']","Yes","['HIF Inhibitor']","Phase 3",1,50,"Anticipated","2018-02-22","2019-10-05",{"$nulls":5},"The purpose of this study is to evaluate the efficacy and safety of molidustat in peritoneal dialysis subjects with renal anemia",null,"An Open-label, Multicenter Study to Investigate the Efficacy and Safety of Oral Molidustat in Peritoneal Dialysis Subjects With Renal Anemia",19353,"Anemia and Renal Insufficiency, Chronic","Anemia|Renal Insufficiency|Renal Insufficiency, Chronic","Hematologic Diseases|Urologic Diseases","Heme & Lymph Diseases|Reproductive and Urogenital","Experimental","Molidustat (BAY85-3934)","Molidustat group","Drug","Molidustat (BAY85-3934)","Starting dose of molidustat once daily (OD) will be titrated based on the subject's Hb (Hemoglobin) response",null,"Molidustat (BAY85-3934)","\n\n * Subject with end-stage kidney disease (ESKD) on peritoneal dialysis prior to assignment and not expected to start maintenance dialysis (e.g., hemodialysis, hemodiafiltration) other than peritoneal dialysis during the study period\n * Body weight > 40 and â‰¤ 160 kg at screening\n * Male or female subject â‰¥ 20 years of age at screening\n * At least one kidney\n * Subjects who meet one of the 1 or 2 following criteria * Subjects untreated with ESA at assignment: Mean of the last 2 Hb level (central laboratory measurement) during the screening period must be â‰¥ 8.0 and < 11.0 g/dL (2 measurements must be taken â‰¥ 2 days apart and the difference between the 2 measurements must be < 1.2 g/dL) with the last screening Hb measurement within 14 days prior to study drug assignment\n    * Subjects pre treated with ESA at assignment: Mean of the last 2 Hb level (central laboratory measurement) during the screening period must be â‰¥ 10.0 and < 13.0 g/dL (2 measurements must be taken â‰¥ 2 days apart and the difference between the 2 measurements must be < 1.2 g/dL) with the last screening Hb measurement within 14 days prior to study drug assignment\n   \n   \n * Subjects who meet one of the 1 or 2 following criteria * Subjects untreated with ESA at assignment: Subject with ESKD on peritoneal dialysis for at least 2 weeks prior to assignment. AND. Subject not received ESA for 8 weeks prior to assignment. OR. In case of the patient washed out from ESAs, when mean of the last 2 Hb level (at least 2 central laboratory measurements must be taken â‰¥ 2 days apart) has decrease to â‰¥ 0.5g/dL from the Hb level (central laboratory measurement) after the last ESA administration, AND the interval from the last ESA administration to the study drug assignment should be over 2 week for epoetin-alpha/beta, 4 weeks for darbepoetin alpha or epoetin beta pegol\n    * Subjects pre treated with ESA at assignment: * Subject with ESKD on peritoneal dialysis for at least 12 weeks prior to assignment\n       * Subject treated with ESA by IV or SC within 8 weeks prior to assignment\n       * Treated with 2 or 4 weekly dose of darbepoetin alfa, 4 weekly dose of epoetin beta pegol, OR 3 times per week, twice per week, weekly or bi-weekly dose of epoetin alfa/beta, and having had no more than one dose change within 8 weeks prior to assignment\n      \n      \n   \n   \n\n","\n\n * New York Heart Association (NYHA) Class III or IV congestive heart failure\n * History of cardio- (cerebro-) vascular events (e.g., unstable angina, myocardial infarction, stroke, pulmonary thromboembolism, and acute limb ischemia) within 6 months prior to randomization\n * Sustained and poorly controlled arterial hypertension (defined as systolic BPâ‰¥ 180mmHg or diastolic BP â‰¥ 110mmHg) or hypotension (defined as systolic BP < 90mmHg) at randomization\n * Proliferative choroidal or retinal disease, such as neovascular age-related macular degeneration or proliferative diabetic retinopathy requiring invasive treatment (e.g., intraocular injections or laser photocoagulation)",{"$nulls":4},"Actual","2018-02-01","Actual","Anticipated","2019-11-09","Anticipated","2018-05-01","2018-01-26","2018-01-26","2018-05-28","Yes",null,"Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","20 Years",null,"All",null,"No",{"$nulls":4},"No","No",{"$nulls":19},"Responder rate: proportion of responders among the subjects","Responder is defined as meeting all of the following criteria:\n\n(i) Mean of the Hb levels in the target range (ii) â‰¥ 50% of the Hb levels in the target range (iii) No rescue treatment","Week 30 to 36","Mean Hb (Hemoglobin) level|Change in mean Hb level|Rate of rise in Hb (Hemoglobin) level (g/dL/week)|Proportion of subjects who meet each component of the response|Hb level|Change in Hb level|Proportion of subjects with mean hemoglobin levels are in the target range|Proportion of subjects with mean hemoglobin levels are above the target range|Proportion of subjects with mean hemoglobin levels are below the target range|Proportion of subjects with hemoglobin levels in the target range|Proportion of subjects with hemoglobin levels above the target range|Proportion of subjects with hemoglobin levels below the target range|Proportion of subjects whose maximum rise in Hb between each consecutive visits is above 0.5 g/dL/week|Percentage of days in the target Hb range during the evaluation period|Percentage of days in the target Hb range during the treatment period|Rate of rise in Hb level (g/dL/week) between each consecutive visits|Percentage of Hb levels in target range during the evaluation period|Percentage of Hb levels in target range during the treatment period|Proportion of subjects who received at least one rescue treatment|Number of participants with serious adverse events|Maximum concentration (Cmax) of Molidustat|Area under the concentration-time curve (AUC) of Molidustat|EPO (Erythropoietin) serum concentration of Molidustat","Week 30 to 36|Baseline and Week 30 to 36|Up to 8 weeks|Up to 4 weeks|Response:\n\n(i) Mean of the Hb levels in the target range (ii) â‰¥ 50% of the Hb levels in the target range (iii) No rescue treatment|Baseline and Up to Week 36|Up to 36 weeks|Defined as change in Hb level / duration between two visits (weeks)|Defined as the number of measurements in the target range / number of measurements x 100|Baseline, Week 8, Wee16 and Week 36","Week 30 to 36|Up to 36 weeks|%)",{"$nulls":3},"Yatomi, Aichi, Japan, 498-8502|Matsuyama, Ehime, Japan, 790-0024|Fukui, Japan, 918-8503 Kyushu University HospitalFukuoka, Japan, 812-8582 Fukuoka University HospitalFukuoka, Japan, 814-0180 Japanese Red Cross Fukuoka HospitalFukuoka, Japan, 815-8555 Fukushima Medical University HospitalFukushima, Japan, 960-1295 Asahi University HospitalGifu, Japan, 500-8523 National Hospital Organization Kyoto Medical CenterKyoto, Japan, 612-8555 Nara Prefecture General Medical CenterNara, Japan, 630-8581 Niigata City General HospitalNiigata, Japan, 950-1197 Japanese Red Cross Oita HospitalOita, Japan, 870-0033 Osaka General Medical CenterOsaka, Japan, 558-8558|Kitakyushu, Fukuoka, Japan, 802-8555 Jcho Kyusyu HospitalKitakyushu, Fukuoka, Japan, 806-8501 Kurume University HospitalKurume, Fukuoka, Japan, 830-0011|Sapporo, Hokkaido, Japan, 003-0814|Kobe, Hyogo, Japan, 650-0047|Fujisawa, Kanagawa, Japan, 251-8550 Shonan Kamakura General HospitalKamakura, Kanagawa, Japan, 247-8533 Toranomon Hospital KajigayaKawasaki, Kanagawa, Japan, 213-8587 Showa University Fujigaoka HospitalYokohama, Kanagawa, Japan, 227-8501|Sendai, Miyagi, Japan, 983-8512|Shibata, Niigata, Japan, 957-8588|Beppu, Oita, Japan, 874-0011|Uruma, Okinawa, Japan, 904-2293|Izumi, Osaka, Japan, 594-0076",null,"Japan","Aichi Kainan Hospital|Ehime Ehime Prefectural Central Hospital|Fukui-Ken Saiseikai Hospital|Fukuoka Kokura Memorial Hospital|Hokkaido Elm Grove Clinic|Hyogo Kobe City Medical Center General Hospital|Kanagawa Fujisawa City Hospital|Miyagi Tohoku Medical And Pharmaceutical University Hospital|Niigata Niigata Prefectural Shibata Hospital|Oita National Hospital Organization Beppu Medical Center|Okinawa Okinawa Prefectural Chubu Hospital|Osaka Fuchu Hospital",{"$nulls":4},"2018-05-28","2020-05-25T16:39:57.802","2020-05-26T17:10:42.972","NCT03418168"]
["5ecbf4dd307e3d1b1f8d9e80","NCT03418168","2018-06-28","Bayer","BAYN","Recruiting","A Study of Molidustat for Treatment of Renal Anemia in Peritoneal Dialysis Subjects (MIYABI PD)","Molidustat","HIF Inhibitor","Yes","['Molidustat']","Yes","['HIF Inhibitor']","Phase 3",1,50,"Anticipated","2018-02-22","2019-10-05",{"$nulls":5},"The purpose of this study is to evaluate the efficacy and safety of molidustat in peritoneal dialysis subjects with renal anemia",null,"An Open-label, Multicenter Study to Investigate the Efficacy and Safety of Oral Molidustat in Peritoneal Dialysis Subjects With Renal Anemia",19353,"Anemia and Renal Insufficiency, Chronic","Anemia|Renal Insufficiency|Renal Insufficiency, Chronic","Hematologic Diseases|Urologic Diseases","Heme & Lymph Diseases|Reproductive and Urogenital","Experimental","Molidustat (BAY85-3934)","Molidustat group","Drug","Molidustat (BAY85-3934)","Starting dose of molidustat once daily (OD) will be titrated based on the subject's Hb (Hemoglobin) response",null,"Molidustat (BAY85-3934)","\n\n * Subject with end-stage kidney disease (ESKD) on peritoneal dialysis prior to assignment and not expected to start maintenance dialysis (e.g., hemodialysis, hemodiafiltration) other than peritoneal dialysis during the study period\n * Body weight > 40 and â‰¤ 160 kg at screening\n * Male or female subject â‰¥ 20 years of age at screening\n * At least one kidney\n * Subjects who meet one of the 1 or 2 following criteria * Subjects untreated with ESA at assignment: Mean of the last 2 Hb level (central laboratory measurement) during the screening period must be â‰¥ 8.0 and < 11.0 g/dL (2 measurements must be taken â‰¥ 2 days apart and the difference between the 2 measurements must be < 1.2 g/dL) with the last screening Hb measurement within 14 days prior to study drug assignment\n    * Subjects pre treated with ESA at assignment: Mean of the last 2 Hb level (central laboratory measurement) during the screening period must be â‰¥ 10.0 and < 13.0 g/dL (2 measurements must be taken â‰¥ 2 days apart and the difference between the 2 measurements must be < 1.2 g/dL) with the last screening Hb measurement within 14 days prior to study drug assignment\n   \n   \n * Subjects who meet one of the 1 or 2 following criteria * Subjects untreated with ESA at assignment: Subject with ESKD on peritoneal dialysis for at least 2 weeks prior to assignment. AND. Subject not received ESA for 8 weeks prior to assignment. OR. In case of the patient washed out from ESAs, when mean of the last 2 Hb level (at least 2 central laboratory measurements must be taken â‰¥ 2 days apart) has decrease to â‰¥ 0.5g/dL from the Hb level (central laboratory measurement) after the last ESA administration, AND the interval from the last ESA administration to the study drug assignment should be over 2 week for epoetin-alpha/beta, 4 weeks for darbepoetin alpha or epoetin beta pegol\n    * Subjects pre treated with ESA at assignment: * Subject with ESKD on peritoneal dialysis for at least 12 weeks prior to assignment\n       * Subject treated with ESA by IV or SC within 8 weeks prior to assignment\n       * Treated with 2 or 4 weekly dose of darbepoetin alfa, 4 weekly dose of epoetin beta pegol, OR 3 times per week, twice per week, weekly or bi-weekly dose of epoetin alfa/beta, and having had no more than one dose change within 8 weeks prior to assignment\n      \n      \n   \n   \n\n","\n\n * New York Heart Association (NYHA) Class III or IV congestive heart failure\n * History of cardio- (cerebro-) vascular events (e.g., unstable angina, myocardial infarction, stroke, pulmonary thromboembolism, and acute limb ischemia) within 6 months prior to randomization\n * Sustained and poorly controlled arterial hypertension (defined as systolic BPâ‰¥ 180mmHg or diastolic BP â‰¥ 110mmHg) or hypotension (defined as systolic BP < 90mmHg) at randomization\n * Proliferative choroidal or retinal disease, such as neovascular age-related macular degeneration or proliferative diabetic retinopathy requiring invasive treatment (e.g., intraocular injections or laser photocoagulation)",{"$nulls":4},"Actual","2018-02-01","Actual","Anticipated","2019-11-09","Anticipated","2018-06-01","2018-01-26","2018-01-26","2018-06-27","Yes",null,"Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","20 Years",null,"All",null,"No",{"$nulls":4},"No","No",{"$nulls":19},"Responder rate: proportion of responders among the subjects","Responder is defined as meeting all of the following criteria:\n\n(i) Mean of the Hb levels in the target range (ii) â‰¥ 50% of the Hb levels in the target range (iii) No rescue treatment","Week 30 to 36","Mean Hb (Hemoglobin) level|Change in mean Hb level|Rate of rise in Hb (Hemoglobin) level (g/dL/week)|Proportion of subjects who meet each component of the response|Hb level|Change in Hb level|Proportion of subjects with mean hemoglobin levels are in the target range|Proportion of subjects with mean hemoglobin levels are above the target range|Proportion of subjects with mean hemoglobin levels are below the target range|Proportion of subjects with hemoglobin levels in the target range|Proportion of subjects with hemoglobin levels above the target range|Proportion of subjects with hemoglobin levels below the target range|Proportion of subjects whose maximum rise in Hb between each consecutive visits is above 0.5 g/dL/week|Percentage of days in the target Hb range during the evaluation period|Percentage of days in the target Hb range during the treatment period|Rate of rise in Hb level (g/dL/week) between each consecutive visits|Percentage of Hb levels in target range during the evaluation period|Percentage of Hb levels in target range during the treatment period|Proportion of subjects who received at least one rescue treatment|Number of participants with serious adverse events|Maximum concentration (Cmax) of Molidustat|Area under the concentration-time curve (AUC) of Molidustat|EPO (Erythropoietin) serum concentration of Molidustat","Week 30 to 36|Baseline and Week 30 to 36|Up to 8 weeks|Up to 4 weeks|Response:\n\n(i) Mean of the Hb levels in the target range (ii) â‰¥ 50% of the Hb levels in the target range (iii) No rescue treatment|Baseline and Up to Week 36|Up to 36 weeks|Defined as change in Hb level / duration between two visits (weeks)|Defined as the number of measurements in the target range / number of measurements x 100|Baseline, Week 8, Wee16 and Week 36","Week 30 to 36|Up to 36 weeks|%)",{"$nulls":3},"Yatomi, Aichi, Japan, 498-8502|Matsuyama, Ehime, Japan, 790-0024|Fukui, Japan, 918-8503 Kyushu University HospitalFukuoka, Japan, 812-8582 Fukuoka University HospitalFukuoka, Japan, 814-0180 Japanese Red Cross Fukuoka HospitalFukuoka, Japan, 815-8555 Fukushima Medical University HospitalFukushima, Japan, 960-1295 Asahi University HospitalGifu, Japan, 500-8523 National Hospital Organization Kyoto Medical CenterKyoto, Japan, 612-8555 Nara Prefecture General Medical CenterNara, Japan, 630-8581 Niigata City General HospitalNiigata, Japan, 950-1197 Japanese Red Cross Oita HospitalOita, Japan, 870-0033 Osaka General Medical CenterOsaka, Japan, 558-8558|Kitakyushu, Fukuoka, Japan, 802-8555 Jcho Kyusyu HospitalKitakyushu, Fukuoka, Japan, 806-8501 Kurume University HospitalKurume, Fukuoka, Japan, 830-0011|Sapporo, Hokkaido, Japan, 003-0814|Kobe, Hyogo, Japan, 650-0047|Fujisawa, Kanagawa, Japan, 251-8550 Shonan Kamakura General HospitalKamakura, Kanagawa, Japan, 247-8533 Toranomon Hospital KajigayaKawasaki, Kanagawa, Japan, 213-8587 Showa University Fujigaoka HospitalYokohama, Kanagawa, Japan, 227-8501|Sendai, Miyagi, Japan, 983-8512|Shibata, Niigata, Japan, 957-8588|Beppu, Oita, Japan, 874-0011|Uruma, Okinawa, Japan, 904-2293|Izumi, Osaka, Japan, 594-0076",null,"Japan","Aichi Kainan Hospital|Ehime Ehime Prefectural Central Hospital|Fukui-Ken Saiseikai Hospital|Fukuoka Kokura Memorial Hospital|Hokkaido Elm Grove Clinic|Hyogo Kobe City Medical Center General Hospital|Kanagawa Fujisawa City Hospital|Miyagi Tohoku Medical And Pharmaceutical University Hospital|Niigata Niigata Prefectural Shibata Hospital|Oita National Hospital Organization Beppu Medical Center|Okinawa Okinawa Prefectural Chubu Hospital|Osaka Fuchu Hospital",{"$nulls":4},"2018-06-27","2020-05-25T16:39:57.520","2020-05-26T17:10:42.972","NCT03418168"]
["5ecbf4ddfe30261b1a0483f0","NCT03418168","2018-08-27","Bayer","BAYN","Recruiting","A Study of Molidustat for Treatment of Renal Anemia in Peritoneal Dialysis Subjects (MIYABI PD)","Molidustat","HIF Inhibitor","Yes","['Molidustat']","Yes","['HIF Inhibitor']","Phase 3",1,50,"Anticipated","2018-02-22","2019-10-05",{"$nulls":5},"The purpose of this study is to evaluate the efficacy and safety of molidustat in peritoneal dialysis subjects with renal anemia",null,"An Open-label, Multicenter Study to Investigate the Efficacy and Safety of Oral Molidustat in Peritoneal Dialysis Subjects With Renal Anemia",19353,"Anemia and Renal Insufficiency, Chronic","Anemia|Renal Insufficiency|Renal Insufficiency, Chronic","Hematologic Diseases|Urologic Diseases","Heme & Lymph Diseases|Reproductive and Urogenital","Experimental","Molidustat (BAY85-3934)","Molidustat group","Drug","Molidustat (BAY85-3934)","Starting dose of molidustat once daily (OD) will be titrated based on the subject's Hb (Hemoglobin) response",null,"Molidustat (BAY85-3934)","\n\n * Subject with end-stage kidney disease (ESKD) on peritoneal dialysis prior to assignment and not expected to start maintenance dialysis (e.g., hemodialysis, hemodiafiltration) other than peritoneal dialysis during the study period\n * Body weight > 40 and â‰¤ 160 kg at screening\n * Male or female subject â‰¥ 20 years of age at screening\n * At least one kidney\n * Subjects who meet one of the 1 or 2 following criteria * Subjects untreated with ESA at assignment: Mean of the last 2 Hb level (central laboratory measurement) during the screening period must be â‰¥ 8.0 and < 11.0 g/dL (2 measurements must be taken â‰¥ 2 days apart and the difference between the 2 measurements must be < 1.2 g/dL) with the last screening Hb measurement within 14 days prior to study drug assignment\n    * Subjects pre treated with ESA at assignment: Mean of the last 2 Hb level (central laboratory measurement) during the screening period must be â‰¥ 10.0 and < 13.0 g/dL (2 measurements must be taken â‰¥ 2 days apart and the difference between the 2 measurements must be < 1.2 g/dL) with the last screening Hb measurement within 14 days prior to study drug assignment\n   \n   \n * Subjects who meet one of the 1 or 2 following criteria * Subjects untreated with ESA at assignment: Subject with ESKD on peritoneal dialysis for at least 2 weeks prior to assignment. AND. Subject not received ESA for 8 weeks prior to assignment. OR. In case of the patient washed out from ESAs, when mean of the last 2 Hb level (at least 2 central laboratory measurements must be taken â‰¥ 2 days apart) has decrease to â‰¥ 0.5g/dL from the Hb level (central laboratory measurement) after the last ESA administration, AND the interval from the last ESA administration to the study drug assignment should be over 2 week for epoetin-alpha/beta, 4 weeks for darbepoetin alpha or epoetin beta pegol\n    * Subjects pre treated with ESA at assignment: * Subject with ESKD on peritoneal dialysis for at least 12 weeks prior to assignment\n       * Subject treated with ESA by IV or SC within 8 weeks prior to assignment\n       * Treated with 2 or 4 weekly dose of darbepoetin alfa, 4 weekly dose of epoetin beta pegol, OR 3 times per week, twice per week, weekly or bi-weekly dose of epoetin alfa/beta, and having had no more than one dose change within 8 weeks prior to assignment\n      \n      \n   \n   \n\n","\n\n * New York Heart Association (NYHA) Class III or IV congestive heart failure\n * History of cardio- (cerebro-) vascular events (e.g., unstable angina, myocardial infarction, stroke, pulmonary thromboembolism, and acute limb ischemia) within 6 months prior to randomization\n * Sustained and poorly controlled arterial hypertension (defined as systolic BPâ‰¥ 180mmHg or diastolic BP â‰¥ 110mmHg) or hypotension (defined as systolic BP < 90mmHg) at randomization\n * Proliferative choroidal or retinal disease, such as neovascular age-related macular degeneration or proliferative diabetic retinopathy requiring invasive treatment (e.g., intraocular injections or laser photocoagulation)",{"$nulls":4},"Actual","2018-02-01","Actual","Anticipated","2019-11-09","Anticipated","2018-08-01","2018-01-26","2018-01-26","2018-08-24","Yes",null,"Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","20 Years",null,"All",null,"No",{"$nulls":4},"No","No",{"$nulls":19},"Responder rate: proportion of responders among the subjects","Responder is defined as meeting all of the following criteria:\n\n(i) Mean of the Hb levels in the target range (ii) â‰¥ 50% of the Hb levels in the target range (iii) No rescue treatment","Week 30 to 36","Mean Hb (Hemoglobin) level|Change in mean Hb level|Rate of rise in Hb (Hemoglobin) level (g/dL/week)|Proportion of subjects who meet each component of the response|Hb level|Change in Hb level|Proportion of subjects with mean hemoglobin levels are in the target range|Proportion of subjects with mean hemoglobin levels are above the target range|Proportion of subjects with mean hemoglobin levels are below the target range|Proportion of subjects with hemoglobin levels in the target range|Proportion of subjects with hemoglobin levels above the target range|Proportion of subjects with hemoglobin levels below the target range|Proportion of subjects whose maximum rise in Hb between each consecutive visits is above 0.5 g/dL/week|Percentage of days in the target Hb range during the evaluation period|Percentage of days in the target Hb range during the treatment period|Rate of rise in Hb level (g/dL/week) between each consecutive visits|Percentage of Hb levels in target range during the evaluation period|Percentage of Hb levels in target range during the treatment period|Proportion of subjects who received at least one rescue treatment|Number of participants with serious adverse events|Maximum concentration (Cmax) of Molidustat|Area under the concentration-time curve (AUC) of Molidustat|EPO (Erythropoietin) serum concentration of Molidustat","Week 30 to 36|Baseline and Week 30 to 36|Up to 8 weeks|Up to 4 weeks|Response:\n\n(i) Mean of the Hb levels in the target range (ii) â‰¥ 50% of the Hb levels in the target range (iii) No rescue treatment|Baseline and Up to Week 36|Up to 36 weeks|Defined as change in Hb level / duration between two visits (weeks)|Defined as the number of measurements in the target range / number of measurements x 100|Baseline, Week 8, Wee16 and Week 36","Week 30 to 36|Up to 36 weeks|%)","clinical-trials-contact@bayer.com","Bayer Clinical Trials Contact","(+) 1-888-8422937","Yatomi, Aichi, Japan, 498-8502|Matsuyama, Ehime, Japan, 790-0024|Fukui, Japan, 918-8503 Kyushu University HospitalFukuoka, Japan, 812-8582 Fukuoka University HospitalFukuoka, Japan, 814-0180 Japanese Red Cross Fukuoka HospitalFukuoka, Japan, 815-8555 Fukushima Medical University HospitalFukushima, Japan, 960-1295 Asahi University HospitalGifu, Japan, 500-8523 National Hospital Organization Kyoto Medical CenterKyoto, Japan, 612-8555 Nara Prefecture General Medical CenterNara, Japan, 630-8581 Niigata City General HospitalNiigata, Japan, 950-1197 Japanese Red Cross Oita HospitalOita, Japan, 870-0033 Osaka General Medical CenterOsaka, Japan, 558-8558|Kitakyushu, Fukuoka, Japan, 802-8555 Jcho Kyusyu HospitalKitakyushu, Fukuoka, Japan, 806-8501 Kurume University HospitalKurume, Fukuoka, Japan, 830-0011|Sapporo, Hokkaido, Japan, 003-0814|Kobe, Hyogo, Japan, 650-0047|Fujisawa, Kanagawa, Japan, 251-8550 Shonan Kamakura General HospitalKamakura, Kanagawa, Japan, 247-8533 Toranomon Hospital KajigayaKawasaki, Kanagawa, Japan, 213-8587 Showa University Fujigaoka HospitalYokohama, Kanagawa, Japan, 227-8501|Sendai, Miyagi, Japan, 983-8512|Shibata, Niigata, Japan, 957-8588|Beppu, Oita, Japan, 874-0011|Uruma, Okinawa, Japan, 904-2293|Izumi, Osaka, Japan, 594-0076",null,"Japan","Aichi Kainan Hospital|Ehime Ehime Prefectural Central Hospital|Fukui-Ken Saiseikai Hospital|Fukuoka Kokura Memorial Hospital|Hokkaido Elm Grove Clinic|Hyogo Kobe City Medical Center General Hospital|Kanagawa Fujisawa City Hospital|Miyagi Tohoku Medical And Pharmaceutical University Hospital|Niigata Niigata Prefectural Shibata Hospital|Oita National Hospital Organization Beppu Medical Center|Okinawa Okinawa Prefectural Chubu Hospital|Osaka Fuchu Hospital",{"$nulls":4},"2018-08-24","2020-05-25T16:39:57.896","2020-05-26T17:10:42.972","NCT03418168"]
["5ecbf4ddfeab101b15530a1f","NCT03418168","2018-11-20","Bayer","BAYN","Active, not recruiting","A Study of Molidustat for Treatment of Renal Anemia in Peritoneal Dialysis Subjects (MIYABI PD)","Molidustat","HIF Inhibitor","Yes","['Molidustat']","Yes","['HIF Inhibitor']","Phase 3",1,51,"Actual","2018-02-22","2019-07-31",{"$nulls":5},"The purpose of this study is to evaluate the efficacy and safety of molidustat in peritoneal dialysis subjects with renal anemia",null,"An Open-label, Multicenter Study to Investigate the Efficacy and Safety of Oral Molidustat in Peritoneal Dialysis Subjects With Renal Anemia",19353,"Anemia and Renal Insufficiency, Chronic","Anemia|Renal Insufficiency|Renal Insufficiency, Chronic","Hematologic Diseases|Urologic Diseases","Heme & Lymph Diseases|Reproductive and Urogenital","Experimental","Molidustat (BAY85-3934)","Molidustat group","Drug","Molidustat (BAY85-3934)","Starting dose of molidustat once daily (OD) will be titrated based on the subject's Hb (Hemoglobin) response",null,"Molidustat (BAY85-3934)","\n\n * Subject with end-stage kidney disease (ESKD) on peritoneal dialysis prior to assignment and not expected to start maintenance dialysis (e.g., hemodialysis, hemodiafiltration) other than peritoneal dialysis during the study period\n * Body weight > 40 and â‰¤ 160 kg at screening\n * Male or female subject â‰¥ 20 years of age at screening\n * At least one kidney\n * Subjects who meet one of the 1 or 2 following criteria * Subjects untreated with ESA at assignment: Mean of the last 2 Hb level (central laboratory measurement) during the screening period must be â‰¥ 8.0 and < 11.0 g/dL (2 measurements must be taken â‰¥ 2 days apart and the difference between the 2 measurements must be < 1.2 g/dL) with the last screening Hb measurement within 14 days prior to study drug assignment\n    * Subjects pre treated with ESA at assignment: Mean of the last 2 Hb level (central laboratory measurement) during the screening period must be â‰¥ 10.0 and < 13.0 g/dL (2 measurements must be taken â‰¥ 2 days apart and the difference between the 2 measurements must be < 1.2 g/dL) with the last screening Hb measurement within 14 days prior to study drug assignment\n   \n   \n * Subjects who meet one of the 1 or 2 following criteria * Subjects untreated with ESA at assignment: Subject with ESKD on peritoneal dialysis for at least 2 weeks prior to assignment. AND. Subject not received ESA for 8 weeks prior to assignment. OR. In case of the patient washed out from ESAs, when mean of the last 2 Hb level (at least 2 central laboratory measurements must be taken â‰¥ 2 days apart) has decrease to â‰¥ 0.5g/dL from the Hb level (central laboratory measurement) after the last ESA administration, AND the interval from the last ESA administration to the study drug assignment should be over 2 week for epoetin-alpha/beta, 4 weeks for darbepoetin alpha or epoetin beta pegol\n    * Subjects pre treated with ESA at assignment: * Subject with ESKD on peritoneal dialysis for at least 12 weeks prior to assignment\n       * Subject treated with ESA by IV or SC within 8 weeks prior to assignment\n       * Treated with 2 or 4 weekly dose of darbepoetin alfa, 4 weekly dose of epoetin beta pegol, OR 3 times per week, twice per week, weekly or bi-weekly dose of epoetin alfa/beta, and having had no more than one dose change within 8 weeks prior to assignment\n      \n      \n   \n   \n\n","\n\n * New York Heart Association (NYHA) Class III or IV congestive heart failure\n * History of cardio- (cerebro-) vascular events (e.g., unstable angina, myocardial infarction, stroke, pulmonary thromboembolism, and acute limb ischemia) within 6 months prior to randomization\n * Sustained and poorly controlled arterial hypertension (defined as systolic BPâ‰¥ 180mmHg or diastolic BP â‰¥ 110mmHg) or hypotension (defined as systolic BP < 90mmHg) at randomization\n * Proliferative choroidal or retinal disease, such as neovascular age-related macular degeneration or proliferative diabetic retinopathy requiring invasive treatment (e.g., intraocular injections or laser photocoagulation)",{"$nulls":4},"Actual","2018-02-01","Actual","Anticipated","2019-08-31","Anticipated","2018-11-01","2018-01-26","2018-01-26","2018-11-18","Yes",null,"Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","20 Years",null,"All",null,"No",{"$nulls":4},"No","No",{"$nulls":19},"Responder rate: proportion of responders among the subjects","Responder is defined as meeting all of the following criteria:\n\n(i) Mean of the Hb levels in the target range (ii) â‰¥ 50% of the Hb levels in the target range (iii) No rescue treatment","Week 30 to 36","Mean Hb (Hemoglobin) level|Change in mean Hb level|Rate of rise in Hb (Hemoglobin) level (g/dL/week)|Proportion of subjects who meet each component of the response|Hb level|Change in Hb level|Proportion of subjects with mean hemoglobin levels are in the target range|Proportion of subjects with mean hemoglobin levels are above the target range|Proportion of subjects with mean hemoglobin levels are below the target range|Proportion of subjects with hemoglobin levels in the target range|Proportion of subjects with hemoglobin levels above the target range|Proportion of subjects with hemoglobin levels below the target range|Proportion of subjects whose maximum rise in Hb between each consecutive visits is above 0.5 g/dL/week|Percentage of days in the target Hb range during the evaluation period|Percentage of days in the target Hb range during the treatment period|Rate of rise in Hb level (g/dL/week) between each consecutive visits|Percentage of Hb levels in target range during the evaluation period|Percentage of Hb levels in target range during the treatment period|Proportion of subjects who received at least one rescue treatment|Number of participants with serious adverse events|Maximum concentration (Cmax) of Molidustat|Area under the concentration-time curve (AUC) of Molidustat|EPO (Erythropoietin) serum concentration of Molidustat","Week 30 to 36|Baseline and Week 30 to 36|Up to 8 weeks|Up to 4 weeks|Response:\n\n(i) Mean of the Hb levels in the target range (ii) â‰¥ 50% of the Hb levels in the target range (iii) No rescue treatment|Baseline and Up to Week 36|Up to 36 weeks|Defined as change in Hb level / duration between two visits (weeks)|Defined as the number of measurements in the target range / number of measurements x 100|Baseline, Week 8, Wee16 and Week 36","Week 30 to 36|Up to 36 weeks|%)",{"$nulls":3},"Yatomi, Aichi, Japan, 498-8502|Matsuyama, Ehime, Japan, 790-0024|Fukui, Japan, 918-8503 Kyushu University HospitalFukuoka, Japan, 812-8582 Fukuoka University HospitalFukuoka, Japan, 814-0180 Japanese Red Cross Fukuoka HospitalFukuoka, Japan, 815-8555 Fukushima Medical University HospitalFukushima, Japan, 960-1295 Asahi University HospitalGifu, Japan, 500-8523 National Hospital Organization Kyoto Medical CenterKyoto, Japan, 612-8555 Nara Prefecture General Medical CenterNara, Japan, 630-8581 Niigata City General HospitalNiigata, Japan, 950-1197 Japanese Red Cross Oita HospitalOita, Japan, 870-0033 Osaka General Medical CenterOsaka, Japan, 558-8558|Kitakyushu, Fukuoka, Japan, 802-8555 Jcho Kyushu HospitalKitakyushu, Fukuoka, Japan, 806-8501 Kurume University HospitalKurume, Fukuoka, Japan, 830-0011|Sapporo, Hokkaido, Japan, 003-0814|Kobe, Hyogo, Japan, 650-0047|Fujisawa, Kanagawa, Japan, 251-8550 Shonan Kamakura General HospitalKamakura, Kanagawa, Japan, 247-8533 Toranomon Hospital KajigayaKawasaki, Kanagawa, Japan, 213-8587 Showa University Fujigaoka HospitalYokohama, Kanagawa, Japan, 227-8501|Sendai, Miyagi, Japan, 983-8512|Shibata, Niigata, Japan, 957-8588|Beppu, Oita, Japan, 874-0011|Uruma, Okinawa, Japan, 904-2293|Izumi, Osaka, Japan, 594-0076",null,"Japan","Aichi Kainan Hospital|Ehime Ehime Prefectural Central Hospital|Fukui-Ken Saiseikai Hospital|Fukuoka Kokura Memorial Hospital|Hokkaido Elm Grove Clinic|Hyogo Kobe City Medical Center General Hospital|Kanagawa Fujisawa City Hospital|Miyagi Tohoku Medical And Pharmaceutical University Hospital|Niigata Niigata Prefectural Shibata Hospital|Oita National Hospital Organization Beppu Medical Center|Okinawa Okinawa Prefectural Chubu Hospital|Osaka Fuchu Hospital",{"$nulls":4},"2018-11-18","2020-05-25T16:39:57.906","2020-05-26T17:10:42.972","NCT03418168"]
["5ecbf4defeab101b15530a20","NCT03418168","2019-02-18","Bayer","BAYN","Active, not recruiting","A Study of Molidustat for Treatment of Renal Anemia in Peritoneal Dialysis Subjects (MIYABI PD)","Molidustat","HIF Inhibitor","Yes","['Molidustat']","Yes","['HIF Inhibitor']","Phase 3",1,51,"Actual","2018-02-22","2019-07-31",{"$nulls":5},"The purpose of this study is to evaluate the efficacy and safety of molidustat in peritoneal dialysis subjects with renal anemia",null,"An Open-label, Multicenter Study to Investigate the Efficacy and Safety of Oral Molidustat in Peritoneal Dialysis Subjects With Renal Anemia",19353,"Anemia and Renal Insufficiency, Chronic","Anemia|Renal Insufficiency|Renal Insufficiency, Chronic","Hematologic Diseases|Urologic Diseases","Heme & Lymph Diseases|Reproductive and Urogenital","Experimental","Molidustat (BAY85-3934)","Molidustat group","Drug","Molidustat (BAY85-3934)","Starting dose of molidustat once daily (OD) will be titrated based on the subject's Hb (Hemoglobin) response",null,"Molidustat (BAY85-3934)","\n\n * Subject with end-stage kidney disease (ESKD) on peritoneal dialysis prior to assignment and not expected to start maintenance dialysis (e.g., hemodialysis, hemodiafiltration) other than peritoneal dialysis during the study period\n * Body weight > 40 and â‰¤ 160 kg at screening\n * Male or female subject â‰¥ 20 years of age at screening\n * At least one kidney\n * Subjects who meet one of the 1 or 2 following criteria * Subjects untreated with ESA at assignment: Mean of the last 2 Hb level (central laboratory measurement) during the screening period must be â‰¥ 8.0 and < 11.0 g/dL (2 measurements must be taken â‰¥ 2 days apart and the difference between the 2 measurements must be < 1.2 g/dL) with the last screening Hb measurement within 14 days prior to study drug assignment\n    * Subjects pre treated with ESA at assignment: Mean of the last 2 Hb level (central laboratory measurement) during the screening period must be â‰¥ 10.0 and < 13.0 g/dL (2 measurements must be taken â‰¥ 2 days apart and the difference between the 2 measurements must be < 1.2 g/dL) with the last screening Hb measurement within 14 days prior to study drug assignment\n   \n   \n * Subjects who meet one of the 1 or 2 following criteria * Subjects untreated with ESA at assignment: Subject with ESKD on peritoneal dialysis for at least 2 weeks prior to assignment. AND. Subject not received ESA for 8 weeks prior to assignment. OR. In case of the patient washed out from ESAs, when mean of the last 2 Hb level (at least 2 central laboratory measurements must be taken â‰¥ 2 days apart) has decrease to â‰¥ 0.5g/dL from the Hb level (central laboratory measurement) after the last ESA administration, AND the interval from the last ESA administration to the study drug assignment should be over 2 week for epoetin-alpha/beta, 4 weeks for darbepoetin alpha or epoetin beta pegol\n    * Subjects pre treated with ESA at assignment: * Subject with ESKD on peritoneal dialysis for at least 12 weeks prior to assignment\n       * Subject treated with ESA by IV or SC within 8 weeks prior to assignment\n       * Treated with 2 or 4 weekly dose of darbepoetin alfa, 4 weekly dose of epoetin beta pegol, OR 3 times per week, twice per week, weekly or bi-weekly dose of epoetin alfa/beta, and having had no more than one dose change within 8 weeks prior to assignment\n      \n      \n   \n   \n\n","\n\n * New York Heart Association (NYHA) Class III or IV congestive heart failure\n * History of cardio- (cerebro-) vascular events (e.g., unstable angina, myocardial infarction, stroke, pulmonary thromboembolism, and acute limb ischemia) within 6 months prior to randomization\n * Sustained and poorly controlled arterial hypertension (defined as systolic BPâ‰¥ 180mmHg or diastolic BP â‰¥ 110mmHg) or hypotension (defined as systolic BP < 90mmHg) at randomization\n * Proliferative choroidal or retinal disease, such as neovascular age-related macular degeneration or proliferative diabetic retinopathy requiring invasive treatment (e.g., intraocular injections or laser photocoagulation)",{"$nulls":4},"Actual","2018-02-01","Actual","Anticipated","2019-08-31","Anticipated","2019-02-01","2018-01-26","2018-01-26","2019-02-15","Yes",null,"Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","20 Years",null,"All",null,"No",{"$nulls":4},"No","No",{"$nulls":19},"Responder rate: proportion of responders among the subjects","Responder is defined as meeting all of the following criteria:\n\n(i) Mean of the Hb levels in the target range (ii) â‰¥ 50% of the Hb levels in the target range (iii) No rescue treatment","Week 30 to 36","Mean Hb (Hemoglobin) level|Change in mean Hb level|Rate of rise in Hb (Hemoglobin) level (g/dL/week)|Proportion of subjects who meet each component of the response|Hb level|Change in Hb level|Proportion of subjects with mean hemoglobin levels are in the target range|Proportion of subjects with mean hemoglobin levels are above the target range|Proportion of subjects with mean hemoglobin levels are below the target range|Proportion of subjects with hemoglobin levels in the target range|Proportion of subjects with hemoglobin levels above the target range|Proportion of subjects with hemoglobin levels below the target range|Proportion of subjects whose maximum rise in Hb between each consecutive visits is above 0.5 g/dL/week|Percentage of days in the target Hb range during the evaluation period|Percentage of days in the target Hb range during the treatment period|Rate of rise in Hb level (g/dL/week) between each consecutive visits|Percentage of Hb levels in target range during the evaluation period|Percentage of Hb levels in target range during the treatment period|Proportion of subjects who received at least one rescue treatment|Number of participants with serious adverse events|Maximum concentration (Cmax) of Molidustat|Area under the concentration-time curve (AUC) of Molidustat|EPO (Erythropoietin) serum concentration of Molidustat","Week 30 to 36|Baseline and Week 30 to 36|Up to 8 weeks|Up to 4 weeks|Response:\n\n(i) Mean of the Hb levels in the target range (ii) â‰¥ 50% of the Hb levels in the target range (iii) No rescue treatment|Baseline and Up to Week 36|Up to 36 weeks|Defined as change in Hb level / duration between two visits (weeks)|Defined as the number of measurements in the target range / number of measurements x 100|Baseline, Week 8, Wee16 and Week 36","Week 30 to 36|Up to 36 weeks|%)",{"$nulls":3},"Yatomi, Aichi, Japan, 498-8502|Matsuyama, Ehime, Japan, 790-0024|Fukui, Japan, 918-8503 Kyushu University HospitalFukuoka, Japan, 812-8582 Fukuoka University HospitalFukuoka, Japan, 814-0180 Japanese Red Cross Fukuoka HospitalFukuoka, Japan, 815-8555 Fukushima Medical University HospitalFukushima, Japan, 960-1295 Asahi University HospitalGifu, Japan, 500-8523 National Hospital Organization Kyoto Medical CenterKyoto, Japan, 612-8555 Nara Prefecture General Medical CenterNara, Japan, 630-8581 Niigata City General HospitalNiigata, Japan, 950-1197 Japanese Red Cross Oita HospitalOita, Japan, 870-0033 Osaka General Medical CenterOsaka, Japan, 558-8558|Kitakyushu, Fukuoka, Japan, 802-8555 Jcho Kyushu HospitalKitakyushu, Fukuoka, Japan, 806-8501 Kurume University HospitalKurume, Fukuoka, Japan, 830-0011|Sapporo, Hokkaido, Japan, 003-0814|Kobe, Hyogo, Japan, 650-0047|Fujisawa, Kanagawa, Japan, 251-8550 Shonan Kamakura General HospitalKamakura, Kanagawa, Japan, 247-8533 Toranomon Hospital KajigayaKawasaki, Kanagawa, Japan, 213-8587 Showa University Fujigaoka HospitalYokohama, Kanagawa, Japan, 227-8501|Sendai, Miyagi, Japan, 983-8512|Shibata, Niigata, Japan, 957-8588|Beppu, Oita, Japan, 874-0011|Uruma, Okinawa, Japan, 904-2293|Izumi, Osaka, Japan, 594-0076",null,"Japan","Aichi Kainan Hospital|Ehime Ehime Prefectural Central Hospital|Fukui-Ken Saiseikai Hospital|Fukuoka Kokura Memorial Hospital|Hokkaido Elm Grove Clinic|Hyogo Kobe City Medical Center General Hospital|Kanagawa Fujisawa City Hospital|Miyagi Tohoku Medical And Pharmaceutical University Hospital|Niigata Niigata Prefectural Shibata Hospital|Oita National Hospital Organization Beppu Medical Center|Okinawa Okinawa Prefectural Chubu Hospital|Osaka Fuchu Hospital",{"$nulls":4},"2019-02-15","2020-05-25T16:39:58.350","2020-05-26T17:10:42.972","NCT03418168"]
["5ecbf4de11702c1b1b916bfd","NCT03418168","2019-04-18","Bayer","BAYN","Active, not recruiting","A Study of Molidustat for Treatment of Renal Anemia in Peritoneal Dialysis Subjects (MIYABI PD)","Molidustat","HIF Inhibitor","Yes","['Molidustat']","Yes","['HIF Inhibitor']","Phase 3",1,51,"Actual","2018-02-22","2019-07-31",{"$nulls":5},"The purpose of this study is to evaluate the efficacy and safety of molidustat in peritoneal dialysis subjects with renal anemia",null,"An Open-label, Multicenter Study to Investigate the Efficacy and Safety of Oral Molidustat in Peritoneal Dialysis Subjects With Renal Anemia",19353,"Anemia and Renal Insufficiency, Chronic","Anemia|Renal Insufficiency|Renal Insufficiency, Chronic","Hematologic Diseases|Urologic Diseases","Heme & Lymph Diseases|Reproductive and Urogenital","Experimental","Molidustat (BAY85-3934)","Molidustat group","Drug","Molidustat (BAY85-3934)","Starting dose of molidustat once daily (OD) will be titrated based on the subject's Hb (Hemoglobin) response",null,"Molidustat (BAY85-3934)","\n\n * Subject with end-stage kidney disease (ESKD) on peritoneal dialysis prior to assignment and not expected to start maintenance dialysis (e.g., hemodialysis, hemodiafiltration) other than peritoneal dialysis during the study period\n * Body weight > 40 and â‰¤ 160 kg at screening\n * Male or female subject â‰¥ 20 years of age at screening\n * At least one kidney\n * Subjects who meet one of the 1 or 2 following criteria * Subjects untreated with ESA at assignment: Mean of the last 2 Hb level (central laboratory measurement) during the screening period must be â‰¥ 8.0 and < 11.0 g/dL (2 measurements must be taken â‰¥ 2 days apart and the difference between the 2 measurements must be < 1.2 g/dL) with the last screening Hb measurement within 14 days prior to study drug assignment\n    * Subjects pre treated with ESA at assignment: Mean of the last 2 Hb level (central laboratory measurement) during the screening period must be â‰¥ 10.0 and < 13.0 g/dL (2 measurements must be taken â‰¥ 2 days apart and the difference between the 2 measurements must be < 1.2 g/dL) with the last screening Hb measurement within 14 days prior to study drug assignment\n   \n   \n * Subjects who meet one of the 1 or 2 following criteria * Subjects untreated with ESA at assignment: Subject with ESKD on peritoneal dialysis for at least 2 weeks prior to assignment. AND. Subject not received ESA for 8 weeks prior to assignment. OR. In case of the patient washed out from ESAs, when mean of the last 2 Hb level (at least 2 central laboratory measurements must be taken â‰¥ 2 days apart) has decrease to â‰¥ 0.5g/dL from the Hb level (central laboratory measurement) after the last ESA administration, AND the interval from the last ESA administration to the study drug assignment should be over 2 week for epoetin-alpha/beta, 4 weeks for darbepoetin alpha or epoetin beta pegol\n    * Subjects pre treated with ESA at assignment: * Subject with ESKD on peritoneal dialysis for at least 12 weeks prior to assignment\n       * Subject treated with ESA by IV or SC within 8 weeks prior to assignment\n       * Treated with 2 or 4 weekly dose of darbepoetin alfa, 4 weekly dose of epoetin beta pegol, OR 3 times per week, twice per week, weekly or bi-weekly dose of epoetin alfa/beta, and having had no more than one dose change within 8 weeks prior to assignment\n      \n      \n   \n   \n\n","\n\n * New York Heart Association (NYHA) Class III or IV congestive heart failure\n * History of cardio- (cerebro-) vascular events (e.g., unstable angina, myocardial infarction, stroke, pulmonary thromboembolism, and acute limb ischemia) within 6 months prior to randomization\n * Sustained and poorly controlled arterial hypertension (defined as systolic BPâ‰¥ 180mmHg or diastolic BP â‰¥ 110mmHg) or hypotension (defined as systolic BP < 90mmHg) at randomization\n * Proliferative choroidal or retinal disease, such as neovascular age-related macular degeneration or proliferative diabetic retinopathy requiring invasive treatment (e.g., intraocular injections or laser photocoagulation)",{"$nulls":4},"Actual","2018-02-01","Actual","Anticipated","2019-08-31","Anticipated","2019-04-01","2018-01-26","2018-01-26","2019-04-17","Yes",null,"Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","20 Years",null,"All",null,"No",{"$nulls":4},"No","No",{"$nulls":19},"Responder rate: proportion of responders among the subjects","Responder is defined as meeting all of the following criteria:\n\n(i) Mean of the Hb levels in the target range (ii) â‰¥ 50% of the Hb levels in the target range (iii) No rescue treatment","Week 30 to 36","Mean Hb (Hemoglobin) level|Change in mean Hb level|Rate of rise in Hb (Hemoglobin) level (g/dL/week)|Proportion of subjects who meet each component of the response|Hb level|Change in Hb level|Proportion of subjects with mean hemoglobin levels are in the target range|Proportion of subjects with mean hemoglobin levels are above the target range|Proportion of subjects with mean hemoglobin levels are below the target range|Proportion of subjects with hemoglobin levels in the target range|Proportion of subjects with hemoglobin levels above the target range|Proportion of subjects with hemoglobin levels below the target range|Proportion of subjects whose maximum rise in Hb between each consecutive visits is above 0.5 g/dL/week|Percentage of days in the target Hb range during the evaluation period|Percentage of days in the target Hb range during the treatment period|Rate of rise in Hb level (g/dL/week) between each consecutive visits|Percentage of Hb levels in target range during the evaluation period|Percentage of Hb levels in target range during the treatment period|Proportion of subjects who received at least one rescue treatment|Number of participants with serious adverse events|Maximum concentration (Cmax) of Molidustat|Area under the concentration-time curve (AUC) of Molidustat|EPO (Erythropoietin) serum concentration of Molidustat","Week 30 to 36|Baseline and Week 30 to 36|Up to 8 weeks|Up to 4 weeks|Response:\n\n(i) Mean of the Hb levels in the target range (ii) â‰¥ 50% of the Hb levels in the target range (iii) No rescue treatment|Baseline and Up to Week 36|Up to 36 weeks|Defined as change in Hb level / duration between two visits (weeks)|Defined as the number of measurements in the target range / number of measurements x 100|Baseline, Week 8, Wee16 and Week 36","Week 30 to 36|Up to 36 weeks|%)",{"$nulls":3},"Yatomi, Aichi, Japan, 498-8502|Matsuyama, Ehime, Japan, 790-0024|Fukui, Japan, 918-8503 Kyushu University HospitalFukuoka, Japan, 812-8582 Fukuoka University HospitalFukuoka, Japan, 814-0180 Japanese Red Cross Fukuoka HospitalFukuoka, Japan, 815-8555 Fukushima Medical University HospitalFukushima, Japan, 960-1295 Asahi University HospitalGifu, Japan, 500-8523 National Hospital Organization Kyoto Medical CenterKyoto, Japan, 612-8555 Nara Prefecture General Medical CenterNara, Japan, 630-8581 Niigata City General HospitalNiigata, Japan, 950-1197 Japanese Red Cross Oita HospitalOita, Japan, 870-0033 Osaka General Medical CenterOsaka, Japan, 558-8558|Kitakyushu, Fukuoka, Japan, 802-8555 Jcho Kyushu HospitalKitakyushu, Fukuoka, Japan, 806-8501 Kurume University HospitalKurume, Fukuoka, Japan, 830-0011|Sapporo, Hokkaido, Japan, 003-0814|Kobe, Hyogo, Japan, 650-0047|Fujisawa, Kanagawa, Japan, 251-8550 Shonan Kamakura General HospitalKamakura, Kanagawa, Japan, 247-8533 Toranomon Hospital KajigayaKawasaki, Kanagawa, Japan, 213-8587 Showa University Fujigaoka HospitalYokohama, Kanagawa, Japan, 227-8501|Sendai, Miyagi, Japan, 983-8512|Shibata, Niigata, Japan, 957-8588|Beppu, Oita, Japan, 874-0011|Uruma, Okinawa, Japan, 904-2293|Izumi, Osaka, Japan, 594-0076",null,"Japan","Aichi Kainan Hospital|Ehime Ehime Prefectural Central Hospital|Fukui-Ken Saiseikai Hospital|Fukuoka Kokura Memorial Hospital|Hokkaido Elm Grove Clinic|Hyogo Kobe City Medical Center General Hospital|Kanagawa Fujisawa City Hospital|Miyagi Tohoku Medical And Pharmaceutical University Hospital|Niigata Niigata Prefectural Shibata Hospital|Oita National Hospital Organization Beppu Medical Center|Okinawa Okinawa Prefectural Chubu Hospital|Osaka Fuchu Hospital",{"$nulls":4},"2019-04-17","2020-05-25T16:39:58.326","2020-05-26T17:10:42.972","NCT03418168"]
["5ecbf4dffe30261b1a0483f3","NCT03418168","2019-07-18","Bayer","BAYN","Active, not recruiting","A Study of Molidustat for Treatment of Renal Anemia in Peritoneal Dialysis Subjects (MIYABI PD)","Molidustat","HIF Inhibitor","Yes","['Molidustat']","Yes","['HIF Inhibitor']","Phase 3",1,51,"Actual","2018-02-22","2019-07-31",{"$nulls":5},"The purpose of this study is to evaluate the efficacy and safety of molidustat in peritoneal dialysis subjects with renal anemia",null,"An Open-label, Multicenter Study to Investigate the Efficacy and Safety of Oral Molidustat in Peritoneal Dialysis Subjects With Renal Anemia",19353,"Anemia and Renal Insufficiency, Chronic","Anemia|Renal Insufficiency|Renal Insufficiency, Chronic","Hematologic Diseases|Urologic Diseases","Heme & Lymph Diseases|Reproductive and Urogenital","Experimental","Molidustat (BAY85-3934)","Molidustat group","Drug","Molidustat (BAY85-3934)","Starting dose of molidustat once daily (OD) will be titrated based on the subject's Hb (Hemoglobin) response",null,"Molidustat (BAY85-3934)","\n\n * Subject with end-stage kidney disease (ESKD) on peritoneal dialysis prior to assignment and not expected to start maintenance dialysis (e.g., hemodialysis, hemodiafiltration) other than peritoneal dialysis during the study period\n * Body weight > 40 and â‰¤ 160 kg at screening\n * Male or female subject â‰¥ 20 years of age at screening\n * At least one kidney\n * Subjects who meet one of the 1 or 2 following criteria * Subjects untreated with ESA at assignment: Mean of the last 2 Hb level (central laboratory measurement) during the screening period must be â‰¥ 8.0 and < 11.0 g/dL (2 measurements must be taken â‰¥ 2 days apart and the difference between the 2 measurements must be < 1.2 g/dL) with the last screening Hb measurement within 14 days prior to study drug assignment\n    * Subjects pre treated with ESA at assignment: Mean of the last 2 Hb level (central laboratory measurement) during the screening period must be â‰¥ 10.0 and < 13.0 g/dL (2 measurements must be taken â‰¥ 2 days apart and the difference between the 2 measurements must be < 1.2 g/dL) with the last screening Hb measurement within 14 days prior to study drug assignment\n   \n   \n * Subjects who meet one of the 1 or 2 following criteria * Subjects untreated with ESA at assignment: Subject with ESKD on peritoneal dialysis for at least 2 weeks prior to assignment. AND. Subject not received ESA for 8 weeks prior to assignment. OR. In case of the patient washed out from ESAs, when mean of the last 2 Hb level (at least 2 central laboratory measurements must be taken â‰¥ 2 days apart) has decrease to â‰¥ 0.5g/dL from the Hb level (central laboratory measurement) after the last ESA administration, AND the interval from the last ESA administration to the study drug assignment should be over 2 week for epoetin-alpha/beta, 4 weeks for darbepoetin alpha or epoetin beta pegol\n    * Subjects pre treated with ESA at assignment: * Subject with ESKD on peritoneal dialysis for at least 12 weeks prior to assignment\n       * Subject treated with ESA by IV or SC within 8 weeks prior to assignment\n       * Treated with 2 or 4 weekly dose of darbepoetin alfa, 4 weekly dose of epoetin beta pegol, OR 3 times per week, twice per week, weekly or bi-weekly dose of epoetin alfa/beta, and having had no more than one dose change within 8 weeks prior to assignment\n      \n      \n   \n   \n\n","\n\n * New York Heart Association (NYHA) Class III or IV congestive heart failure\n * History of cardio- (cerebro-) vascular events (e.g., unstable angina, myocardial infarction, stroke, pulmonary thromboembolism, and acute limb ischemia) within 6 months prior to randomization\n * Sustained and poorly controlled arterial hypertension (defined as systolic BPâ‰¥ 180mmHg or diastolic BP â‰¥ 110mmHg) or hypotension (defined as systolic BP < 90mmHg) at randomization\n * Proliferative choroidal or retinal disease, such as neovascular age-related macular degeneration or proliferative diabetic retinopathy requiring invasive treatment (e.g., intraocular injections or laser photocoagulation)",{"$nulls":4},"Actual","2018-02-01","Actual","Anticipated","2019-08-31","Anticipated","2019-07-01","2018-01-26","2018-01-26","2019-07-17","Yes",null,"Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","20 Years",null,"All",null,"No",{"$nulls":4},"No","No",{"$nulls":19},"Responder rate: proportion of responders among the subjects","Responder is defined as meeting all of the following criteria:\n\n(i) Mean of the Hb levels in the target range (ii) â‰¥ 50% of the Hb levels in the target range (iii) No rescue treatment","Week 30 to 36","Mean Hb (Hemoglobin) level|Change in mean Hb level|Rate of rise in Hb (Hemoglobin) level (g/dL/week)|Proportion of subjects who meet each component of the response|Hb level|Change in Hb level|Proportion of subjects with mean hemoglobin levels are in the target range|Proportion of subjects with mean hemoglobin levels are above the target range|Proportion of subjects with mean hemoglobin levels are below the target range|Proportion of subjects with hemoglobin levels in the target range|Proportion of subjects with hemoglobin levels above the target range|Proportion of subjects with hemoglobin levels below the target range|Proportion of subjects whose maximum rise in Hb between each consecutive visits is above 0.5 g/dL/week|Percentage of days in the target Hb range during the evaluation period|Percentage of days in the target Hb range during the treatment period|Rate of rise in Hb level (g/dL/week) between each consecutive visits|Percentage of Hb levels in target range during the evaluation period|Percentage of Hb levels in target range during the treatment period|Proportion of subjects who received at least one rescue treatment|Number of participants with serious adverse events|Maximum concentration (Cmax) of Molidustat|Area under the concentration-time curve (AUC) of Molidustat|EPO (Erythropoietin) serum concentration of Molidustat","Week 30 to 36|Baseline and Week 30 to 36|Up to 8 weeks|Up to 4 weeks|Response:\n\n(i) Mean of the Hb levels in the target range (ii) â‰¥ 50% of the Hb levels in the target range (iii) No rescue treatment|Baseline and Up to Week 36|Up to 36 weeks|Defined as change in Hb level / duration between two visits (weeks)|Defined as the number of measurements in the target range / number of measurements x 100|Baseline, Week 8, Wee16 and Week 36","Week 30 to 36|Up to 36 weeks|%)",{"$nulls":3},"Yatomi, Aichi, Japan, 498-8502|Matsuyama, Ehime, Japan, 790-0024|Fukui, Japan, 918-8503 Kyushu University HospitalFukuoka, Japan, 812-8582 Fukuoka University HospitalFukuoka, Japan, 814-0180 Japanese Red Cross Fukuoka HospitalFukuoka, Japan, 815-8555 Fukushima Medical University HospitalFukushima, Japan, 960-1295 Asahi University HospitalGifu, Japan, 500-8523 National Hospital Organization Kyoto Medical CenterKyoto, Japan, 612-8555 Nara Prefecture General Medical CenterNara, Japan, 630-8581 Niigata City General HospitalNiigata, Japan, 950-1197 Japanese Red Cross Oita HospitalOita, Japan, 870-0033 Osaka General Medical CenterOsaka, Japan, 558-8558|Kitakyushu, Fukuoka, Japan, 802-8555 Jcho Kyushu HospitalKitakyushu, Fukuoka, Japan, 806-8501 Kurume University HospitalKurume, Fukuoka, Japan, 830-0011|Sapporo, Hokkaido, Japan, 003-0814|Kobe, Hyogo, Japan, 650-0047|Fujisawa, Kanagawa, Japan, 251-8550 Shonan Kamakura General HospitalKamakura, Kanagawa, Japan, 247-8533 Toranomon Hospital KajigayaKawasaki, Kanagawa, Japan, 213-8587 Showa University Fujigaoka HospitalYokohama, Kanagawa, Japan, 227-8501|Sendai, Miyagi, Japan, 983-8512|Shibata, Niigata, Japan, 957-8588|Beppu, Oita, Japan, 874-0011|Uruma, Okinawa, Japan, 904-2293|Izumi, Osaka, Japan, 594-0076",null,"Japan","Aichi Kainan Hospital|Ehime Ehime Prefectural Central Hospital|Fukui-Ken Saiseikai Hospital|Fukuoka Kokura Memorial Hospital|Hokkaido Elm Grove Clinic|Hyogo Kobe City Medical Center General Hospital|Kanagawa Fujisawa City Hospital|Miyagi Tohoku Medical And Pharmaceutical University Hospital|Niigata Niigata Prefectural Shibata Hospital|Oita National Hospital Organization Beppu Medical Center|Okinawa Okinawa Prefectural Chubu Hospital|Osaka Fuchu Hospital",{"$nulls":4},"2019-07-17","2020-05-25T16:39:59.063","2020-05-26T17:10:42.972","NCT03418168"]
["5ecbf4dbfe30261b1a0483eb","NCT03418493","2018-02-01","Eli Lilly","LLY","Not yet recruiting","A Study of LY3316531 in Healthy Participants and in Participants With Psoriasis","Ly-3316531",null,"Yes","['Ly-3316531']","Unknown",null,"Phase 1",5,102,"Anticipated","2018-01-01","2019-02-01",{"$nulls":5},"The purpose of this study is to evaluate how well LY3316531 is tolerated and what side effects may occur in healthy participants and participants with psoriasis. The study drug will be administered either subcutaneously (SC) (under the skin) or intravenously (IV) (into a vein in the arm).\n\nThis is a three-part study. Participants will enroll in only one part. Parts A and B are for healthy participants and Part C is for participants with psoriasis. Participation could last between 16 and 57 weeks.",null,"A Phase 1 Randomized, Placebo-Controlled Study of LY3316531 in Healthy Subjects and an Open-Label, Single-Dose Study in Patients With Psoriasis",16666,"Psoriasis","Psoriasis","Dermatological Diseases","Derm & Connective Tissue Disorders","Experimental|Placebo Comparator","LY3316531 (Part A)|Placebo (Part A)|LY3316531 (Part B)|Placebo (Part B)|LY3316531 (Part C)","LY3316531 administered IV and/or SC.|Placebo matching LY3316531 administered IV.|Placebo matching LY3316531 administered IV and/or SC.","Drug","LY3316531 - IV|LY3316531 - SC|Placebo - IV|Placebo - SC","Administered IV.|Administered SC.|Placebo - SC.",null,"LY3316531 (Part A)|Placebo (Part A)|LY3316531 (Part B)|Placebo (Part B)|LY3316531 (Part C)","\n\n * Healthy Participants * Are overtly healthy males or females, as determined by medical history and physical examination\n    * Females must be of non-childbearing potential\n    * Are between 18 and 64 years of age, inclusive, at screening\n    * Have a body mass index of 18.0 to 32.0 kilograms per meter squared (kg/mÂ²) inclusive\n    * Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures\n   \n   \n * Psoriasis Participants: * Chronic plaque psoriasis based on an investigator confirmed diagnosis of chronic psoriasis vulgaris for at least 6 months prior to baseline\n    * Meet psoriasis disease activity criteria\n    * Are at least 18 years of age\n    * Have a minimum body weight of 50 kilograms (kg)\n   \n   \n\n","\n\n * Healthy and Psoriasis Participants * Have known or ongoing neuropsychiatric disorders\n    * Have received live vaccine(s) (included attenuated live vaccines) within 28 days of screening or intend to during the study\n    * Have had any malignancy within the past 5 years except for basal cell or squamous cell epithelial carcinomas of the skin that have been resected with no subsequent evidence of recurrence for at least 3 years prior to screening and cervical carcinoma in situ with no evidence of recurrence within 5 years prior to baseline\n    * Show evidence of active or latent tuberculosis (TB)\n    * Have presence of significant uncontrolled cerebro-cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, neurologic or neuropsychiatric disorders or abnormal laboratory values at screening that, in the opinion of the investigator, pose an unacceptable risk to the participant if participating in the study or of interfering with the interpretation of data\n   \n   \n * Psoriasis Participants Only: * Have received treatment with biologic therapies for psoriasis (such as monoclonal antibodies, including marketed or investigational biologic therapy)\n    * Prior or current use of biologics for indications other than psoriasis may be allowed with sponsor approval\n    * Have received systemic nonbiologic psoriasis therapy within 28 days of baseline\n    * Have received topical psoriasis treatment within 14 days of baseline",{"$nulls":4},"Actual","2018-02-01","Actual","Anticipated","2019-09-01","Anticipated","2018-01-01","2018-01-26","2018-01-26","2018-01-26","No",null,"Interventional","Basic Science","Parallel Assignment","Double (Participant, Investigator)","Randomized","18 Years","64 Years","All",null,"Yes",{"$nulls":4},"Yes","No",{"$nulls":17},"I9H-MC-FFAA","Eli Lilly and Company","Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration","A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module","Pre-dose up to 1 year after administration of study drug","Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3316531|PK: Area Under the Concentration Versus Time Curve (AUC) of LY3316531","PK: Cmax of LY3316531|PK: AUC of LY3316531","Pre-dose up to 1 year after administration of study drug","ClinicalTrials.gov@lilly.com","There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or","1-317-615-4559","Glendale, California, United States, 91206|Baltimore, Maryland, United States, 21225Principal Investigator: A Hussaini","California|Maryland","United States","California Clinical Trials Med|Parexel-Phase 1 Baltimore Harb",{"$nulls":3},"Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)","2018-01-26","2020-05-25T16:39:55.893","2020-05-26T17:10:42.972","NCT03418493"]
["5ecbf4dcfe30261b1a0483ec","NCT03418493","2018-02-08","Eli Lilly","LLY","Recruiting","A Study of LY3316531 in Healthy Participants and in Participants With Psoriasis","Ly-3316531",null,"Yes","['Ly-3316531']","Unknown",null,"Phase 1",5,102,"Anticipated","2018-01-30","2019-02-01",{"$nulls":5},"The purpose of this study is to evaluate how well LY3316531 is tolerated and what side effects may occur in healthy participants and participants with psoriasis. The study drug will be administered either subcutaneously (SC) (under the skin) or intravenously (IV) (into a vein in the arm).\n\nThis is a three-part study. Participants will enroll in only one part. Parts A and B are for healthy participants and Part C is for participants with psoriasis. Participation could last between 16 and 57 weeks.",null,"A Phase 1 Randomized, Placebo-Controlled Study of LY3316531 in Healthy Subjects and an Open-Label, Single-Dose Study in Patients With Psoriasis",16666,"Psoriasis","Psoriasis","Dermatological Diseases","Derm & Connective Tissue Disorders","Experimental|Placebo Comparator","LY3316531 (Part A)|Placebo (Part A)|LY3316531 (Part B)|Placebo (Part B)|LY3316531 (Part C)","LY3316531 administered IV and/or SC.|Placebo matching LY3316531 administered IV.|Placebo matching LY3316531 administered IV and/or SC.","Drug","LY3316531 - IV|LY3316531 - SC|Placebo - IV|Placebo - SC","Administered IV.|Administered SC.|Placebo - SC.",null,"LY3316531 (Part A)|Placebo (Part A)|LY3316531 (Part B)|Placebo (Part B)|LY3316531 (Part C)","\n\n * Healthy Participants * Are overtly healthy males or females, as determined by medical history and physical examination\n    * Females must be of non-childbearing potential\n    * Are between 18 and 64 years of age, inclusive, at screening\n    * Have a body mass index of 18.0 to 32.0 kilograms per meter squared (kg/mÂ²) inclusive\n    * Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures\n   \n   \n * Psoriasis Participants: * Chronic plaque psoriasis based on an investigator confirmed diagnosis of chronic psoriasis vulgaris for at least 6 months prior to baseline\n    * Meet psoriasis disease activity criteria\n    * Are at least 18 years of age\n    * Have a minimum body weight of 50 kilograms (kg)\n   \n   \n\n","\n\n * Healthy and Psoriasis Participants * Have known or ongoing neuropsychiatric disorders\n    * Have received live vaccine(s) (included attenuated live vaccines) within 28 days of screening or intend to during the study\n    * Have had any malignancy within the past 5 years except for basal cell or squamous cell epithelial carcinomas of the skin that have been resected with no subsequent evidence of recurrence for at least 3 years prior to screening and cervical carcinoma in situ with no evidence of recurrence within 5 years prior to baseline\n    * Show evidence of active or latent tuberculosis (TB)\n    * Have presence of significant uncontrolled cerebro-cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, neurologic or neuropsychiatric disorders or abnormal laboratory values at screening that, in the opinion of the investigator, pose an unacceptable risk to the participant if participating in the study or of interfering with the interpretation of data\n   \n   \n * Psoriasis Participants Only: * Have received treatment with biologic therapies for psoriasis (such as monoclonal antibodies, including marketed or investigational biologic therapy)\n    * Prior or current use of biologics for indications other than psoriasis may be allowed with sponsor approval\n    * Have received systemic nonbiologic psoriasis therapy within 28 days of baseline\n    * Have received topical psoriasis treatment within 14 days of baseline",{"$nulls":4},"Actual","2018-02-01","Actual","Anticipated","2019-09-01","Anticipated","2018-02-01","2018-01-26","2018-01-26","2018-02-07","No",null,"Interventional","Basic Science","Parallel Assignment","Double (Participant, Investigator)","Randomized","18 Years","64 Years","All",null,"Yes",null,null,"URL: https://www.lillytrialguide.com/en-US/studies/psoriasis/FFAA#?postal= [https://www.lillytrialguide.com/en-US/studies/psoriasis/FFAA#?postal=] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: A Study of LY3316531 in Healthy Participants and in Participants With Psoriasis",null,"Yes","No",{"$nulls":17},"I9H-MC-FFAA","Eli Lilly and Company","Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration","A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module","Pre-dose up to 1 year after administration of study drug","Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3316531|PK: Area Under the Concentration Versus Time Curve (AUC) of LY3316531","PK: Cmax of LY3316531|PK: AUC of LY3316531","Pre-dose up to 1 year after administration of study drug","ClinicalTrials.gov@lilly.com","There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or","1-317-615-4559","Glendale, California, United States, 91206-4140|Baltimore, Maryland, United States, 21225Principal Investigator: Azra Hussaini","California|Maryland","United States","Parexel Early Phase Unit At Glendale|Parexel-Phase 1 Baltimore Harb",{"$nulls":3},"Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)","2018-02-07","2020-05-25T16:39:56.211","2020-05-26T17:10:42.972","NCT03418493"]
["5ecbf4dcfeab101b15530a1a","NCT03418493","2018-04-19","Eli Lilly","LLY","Recruiting","A Study of LY3316531 in Healthy Participants and in Participants With Psoriasis","Ly-3316531",null,"Yes","['Ly-3316531']","Unknown",null,"Phase 1",5,102,"Anticipated","2018-01-30","2019-02-01",{"$nulls":5},"The purpose of this study is to evaluate how well LY3316531 is tolerated and what side effects may occur in healthy participants and participants with psoriasis. The study drug will be administered either subcutaneously (SC) (under the skin) or intravenously (IV) (into a vein in the arm).\n\nThis is a three-part study. Participants will enroll in only one part. Parts A and B are for healthy participants and Part C is for participants with psoriasis. Participation could last between 16 and 57 weeks.",null,"A Phase 1 Randomized, Placebo-Controlled Study of LY3316531 in Healthy Subjects and an Open-Label, Single-Dose Study in Patients With Psoriasis",16666,"Psoriasis","Psoriasis","Dermatological Diseases","Derm & Connective Tissue Disorders","Experimental|Placebo Comparator","LY3316531 (Part A)|Placebo (Part A)|LY3316531 (Part B)|Placebo (Part B)|LY3316531 (Part C)","LY3316531 administered IV and/or SC.|Placebo matching LY3316531 administered IV.|Placebo matching LY3316531 administered IV and/or SC.","Drug","LY3316531 - IV|LY3316531 - SC|Placebo - IV|Placebo - SC","Administered IV.|Administered SC.|Placebo - SC.",null,"LY3316531 (Part A)|Placebo (Part A)|LY3316531 (Part B)|Placebo (Part B)|LY3316531 (Part C)","\n\n * Healthy Participants * Are overtly healthy males or females, as determined by medical history and physical examination\n    * Females must be of non-childbearing potential\n    * Are between 18 and 64 years of age, inclusive, at screening\n    * Have a body mass index of 18.0 to 32.0 kilograms per meter squared (kg/mÂ²) inclusive\n    * Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures\n   \n   \n * Psoriasis Participants: * Chronic plaque psoriasis based on an investigator confirmed diagnosis of chronic psoriasis vulgaris for at least 6 months prior to baseline\n    * Meet psoriasis disease activity criteria\n    * Are at least 18 years of age\n    * Have a minimum body weight of 50 kilograms (kg)\n   \n   \n\n","\n\n * Healthy and Psoriasis Participants * Have known or ongoing neuropsychiatric disorders\n    * Have received live vaccine(s) (included attenuated live vaccines) within 28 days of screening or intend to during the study\n    * Have had any malignancy within the past 5 years except for basal cell or squamous cell epithelial carcinomas of the skin that have been resected with no subsequent evidence of recurrence for at least 3 years prior to screening and cervical carcinoma in situ with no evidence of recurrence within 5 years prior to baseline\n    * Show evidence of active or latent tuberculosis (TB)\n    * Have presence of significant uncontrolled cerebro-cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, neurologic or neuropsychiatric disorders or abnormal laboratory values at screening that, in the opinion of the investigator, pose an unacceptable risk to the participant if participating in the study or of interfering with the interpretation of data\n   \n   \n * Psoriasis Participants Only: * Have received treatment with biologic therapies for psoriasis (such as monoclonal antibodies, including marketed or investigational biologic therapy)\n    * Prior or current use of biologics for indications other than psoriasis may be allowed with sponsor approval\n    * Have received systemic nonbiologic psoriasis therapy within 28 days of baseline\n    * Have received topical psoriasis treatment within 14 days of baseline",{"$nulls":4},"Actual","2018-02-01","Actual","Anticipated","2019-09-01","Anticipated","2018-04-01","2018-01-26","2018-01-26","2018-04-18","No",null,"Interventional","Basic Science","Parallel Assignment","Double (Participant, Investigator)","Randomized","18 Years","64 Years","All",null,"Yes",null,null,"URL: https://www.lillytrialguide.com/en-US/studies/psoriasis/FFAA#?postal= [https://www.lillytrialguide.com/en-US/studies/psoriasis/FFAA#?postal=] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: A Study of LY3316531 in Healthy Participants and in Participants With Psoriasis",null,"Yes","No",{"$nulls":17},"I9H-MC-FFAA","Eli Lilly and Company","Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration","A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module","Pre-dose up to 1 year after administration of study drug","Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3316531|PK: Area Under the Concentration Versus Time Curve (AUC) of LY3316531","PK: Cmax of LY3316531|PK: AUC of LY3316531","Pre-dose up to 1 year after administration of study drug","ClinicalTrials.gov@lilly.com","There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or","1-317-615-4559","Glendale, California, United States, 91206-4140|Baltimore, Maryland, United States, 21225Principal Investigator: Azra Hussaini","California|Maryland","United States","Parexel Early Phase Unit At Glendale|Parexel-Phase 1 Baltimore Harb",{"$nulls":3},"Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)","2018-04-18","2020-05-25T16:39:56.037","2020-05-26T17:10:42.972","NCT03418493"]
["5ecbf4dc307e3d1b1f8d9e7d","NCT03418493","2018-10-23","Eli Lilly","LLY","Recruiting","A Study of LY3316531 in Healthy Participants and in Participants With Psoriasis","Ly-3316531",null,"Yes","['Ly-3316531']","Unknown",null,"Phase 1",5,102,"Anticipated","2018-01-30","2019-02-12",{"$nulls":5},"The purpose of this study is to evaluate how well LY3316531 is tolerated and what side effects may occur in healthy participants and participants with psoriasis. The study drug will be administered either subcutaneously (SC) (under the skin) or intravenously (IV) (into a vein in the arm).\n\nThis is a three-part study. Participants will enroll in only one part. Parts A and B are for healthy participants and Part C is for participants with psoriasis. Participation could last between 16 and 57 weeks.",null,"A Phase 1 Randomized, Placebo-Controlled Study of LY3316531 in Healthy Subjects and an Open-Label, Single-Dose Study in Patients With Psoriasis",16666,"Psoriasis","Psoriasis","Dermatological Diseases","Derm & Connective Tissue Disorders","Experimental|Placebo Comparator","LY3316531 (Part A)|Placebo (Part A)|LY3316531 (Part B)|Placebo (Part B)|LY3316531 (Part C)","LY3316531 administered IV and/or SC.|Placebo matching LY3316531 administered IV.|Placebo matching LY3316531 administered IV and/or SC.","Drug","LY3316531 - IV|LY3316531 - SC|Placebo - IV|Placebo - SC","Administered IV.|Administered SC.|Placebo - SC.",null,"LY3316531 (Part A)|Placebo (Part A)|LY3316531 (Part B)|Placebo (Part B)|LY3316531 (Part C)","\n\n * Healthy Participants * Are overtly healthy males or females, as determined by medical history and physical examination\n    * Females must be of non-childbearing potential\n    * Are between 18 and 64 years of age, inclusive, at screening\n    * Have a body mass index of 18.0 to 32.0 kilograms per meter squared (kg/mÂ²) inclusive\n    * Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures\n   \n   \n * Psoriasis Participants: * Chronic plaque psoriasis based on an investigator confirmed diagnosis of chronic psoriasis vulgaris for at least 6 months prior to baseline\n    * Meet psoriasis disease activity criteria\n    * Are at least 18 years of age\n    * Have a minimum body weight of 50 kilograms (kg)\n   \n   \n\n","\n\n * Healthy and Psoriasis Participants * Have known or ongoing neuropsychiatric disorders\n    * Have received live vaccine(s) (included attenuated live vaccines) within 28 days of screening or intend to during the study\n    * Have had any malignancy within the past 5 years except for basal cell or squamous cell epithelial carcinomas of the skin that have been resected with no subsequent evidence of recurrence for at least 3 years prior to screening and cervical carcinoma in situ with no evidence of recurrence within 5 years prior to baseline\n    * Show evidence of active or latent tuberculosis (TB)\n    * Have presence of significant uncontrolled cerebro-cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, neurologic or neuropsychiatric disorders or abnormal laboratory values at screening that, in the opinion of the investigator, pose an unacceptable risk to the participant if participating in the study or of interfering with the interpretation of data\n   \n   \n * Psoriasis Participants Only: * Have received treatment with biologic therapies for psoriasis (such as monoclonal antibodies, including marketed or investigational biologic therapy)\n    * Prior or current use of biologics for indications other than psoriasis may be allowed with sponsor approval\n    * Have received systemic nonbiologic psoriasis therapy within 28 days of baseline\n    * Have received topical psoriasis treatment within 14 days of baseline",{"$nulls":4},"Actual","2018-02-01","Actual","Anticipated","2019-09-02","Anticipated","2018-10-17","2018-01-26","2018-01-26","2018-10-22","No",null,"Interventional","Basic Science","Parallel Assignment","Double (Participant, Investigator)","Randomized","18 Years","64 Years","All",null,"Yes",null,null,"URL: https://www.lillytrialguide.com/en-US/studies/psoriasis/FFAA#?postal= [https://www.lillytrialguide.com/en-US/studies/psoriasis/FFAA#?postal=] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: A Study of LY3316531 in Healthy Participants and in Participants With Psoriasis",null,"Yes","No",{"$nulls":17},"I9H-MC-FFAA","Eli Lilly and Company","Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration","A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module","Pre-dose up to 1 year after administration of study drug","Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3316531|PK: Area Under the Concentration Versus Time Curve (AUC) of LY3316531","PK: Cmax of LY3316531|PK: AUC of LY3316531","Pre-dose up to 1 year after administration of study drug","ClinicalTrials.gov@lilly.com","There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or","1-317-615-4559","Glendale, California, United States, 91206-4140Principal Investigator: Hakop Gevorkyan|Baltimore, Maryland, United States, 21225Principal Investigator: Azra Hussaini","California|Maryland","United States","Parexel Early Phase Unit At Glendale|Parexel-Phase 1 Baltimore Harbor Hospital Center",{"$nulls":3},"Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)","2018-10-22","2020-05-25T16:39:56.278","2020-05-26T17:10:42.972","NCT03418493"]
["5ecbf4dcfe30261b1a0483ed","NCT03418493","2018-11-20","Eli Lilly","LLY","Recruiting","A Study of LY3316531 in Healthy Participants and in Participants With Psoriasis","Ly-3316531",null,"Yes","['Ly-3316531']","Unknown",null,"Phase 1",5,102,"Anticipated","2018-01-30","2019-02-12",{"$nulls":5},"The purpose of this study is to evaluate how well LY3316531 is tolerated and what side effects may occur in healthy participants and participants with psoriasis. The study drug will be administered either subcutaneously (SC) (under the skin) or intravenously (IV) (into a vein in the arm).\n\nThis is a three-part study. Participants will enroll in only one part. Parts A and B are for healthy participants and Part C is for participants with psoriasis. Participation could last between 16 and 57 weeks.",null,"A Phase 1 Randomized, Placebo-Controlled Study of LY3316531 in Healthy Subjects and an Open-Label, Single-Dose Study in Patients With Psoriasis",16666,"Psoriasis","Psoriasis","Dermatological Diseases","Derm & Connective Tissue Disorders","Experimental|Placebo Comparator","LY3316531 (Part A)|Placebo (Part A)|LY3316531 (Part B)|Placebo (Part B)|LY3316531 (Part C)","LY3316531 administered IV and/or SC.|Placebo matching LY3316531 administered IV.|Placebo matching LY3316531 administered IV and/or SC.","Drug","LY3316531 - IV|LY3316531 - SC|Placebo - IV|Placebo - SC","Administered IV.|Administered SC.|Placebo - SC.",null,"LY3316531 (Part A)|Placebo (Part A)|LY3316531 (Part B)|Placebo (Part B)|LY3316531 (Part C)","\n\n * Healthy Participants * Are overtly healthy males or females, as determined by medical history and physical examination\n    * Females must be of non-childbearing potential\n    * Are between 18 and 64 years of age, inclusive, at screening\n    * Have a body mass index of 18.0 to 32.0 kilograms per meter squared (kg/mÂ²) inclusive\n    * Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures\n   \n   \n * Psoriasis Participants: * Chronic plaque psoriasis based on an investigator confirmed diagnosis of chronic psoriasis vulgaris for at least 6 months prior to baseline\n    * Meet psoriasis disease activity criteria\n    * Are at least 18 years of age\n    * Have a minimum body weight of 50 kilograms (kg)\n   \n   \n\n","\n\n * Healthy and Psoriasis Participants * Have known or ongoing neuropsychiatric disorders\n    * Have received live vaccine(s) (included attenuated live vaccines) within 28 days of screening or intend to during the study\n    * Have had any malignancy within the past 5 years except for basal cell or squamous cell epithelial carcinomas of the skin that have been resected with no subsequent evidence of recurrence for at least 3 years prior to screening and cervical carcinoma in situ with no evidence of recurrence within 5 years prior to baseline\n    * Show evidence of active or latent tuberculosis (TB)\n    * Have presence of significant uncontrolled cerebro-cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, neurologic or neuropsychiatric disorders or abnormal laboratory values at screening that, in the opinion of the investigator, pose an unacceptable risk to the participant if participating in the study or of interfering with the interpretation of data\n   \n   \n * Psoriasis Participants Only: * Have received treatment with biologic therapies for psoriasis (such as monoclonal antibodies, including marketed or investigational biologic therapy)\n    * Prior or current use of biologics for indications other than psoriasis may be allowed with sponsor approval\n    * Have received systemic nonbiologic psoriasis therapy within 28 days of baseline\n    * Have received topical psoriasis treatment within 14 days of baseline",{"$nulls":4},"Actual","2018-02-01","Actual","Anticipated","2019-09-02","Anticipated","2018-11-16","2018-01-26","2018-01-26","2018-11-19","No",null,"Interventional","Basic Science","Parallel Assignment","Double (Participant, Investigator)","Randomized","18 Years","64 Years","All",null,"Yes",null,null,"URL: https://www.lillytrialguide.com/en-US/studies/psoriasis/FFAA#?postal= [https://www.lillytrialguide.com/en-US/studies/psoriasis/FFAA#?postal=] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: A Study of LY3316531 in Healthy Participants and in Participants With Psoriasis",null,"Yes","No",{"$nulls":17},"I9H-MC-FFAA","Eli Lilly and Company","Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration","A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module","Pre-dose up to 1 year after administration of study drug","Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3316531|PK: Area Under the Concentration Versus Time Curve (AUC) of LY3316531","PK: Cmax of LY3316531|PK: AUC of LY3316531","Pre-dose up to 1 year after administration of study drug","ClinicalTrials.gov@lilly.com","There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or","1-317-615-4559","Glendale, California, United States, 91206-4140Principal Investigator: Hakop Gevorkyan|Baltimore, Maryland, United States, 21225Principal Investigator: Azra Hussaini","California|Maryland","United States","Parexel Early Phase Unit At Glendale|Parexel-Phase 1 Baltimore Harbor Hospital Center",{"$nulls":3},"Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)","2018-11-19","2020-05-25T16:39:56.739","2020-05-26T17:10:42.972","NCT03418493"]
["5ecbf4dce2561b1b11905ee7","NCT03418493","2019-01-15","Eli Lilly","LLY","Active, not recruiting","A Study of LY3316531 in Healthy Participants and in Participants With Psoriasis","Ly-3316531",null,"Yes","['Ly-3316531']","Unknown",null,"Phase 1",5,102,"Anticipated","2018-01-30","2019-02-12",{"$nulls":5},"The purpose of this study is to evaluate how well LY3316531 is tolerated and what side effects may occur in healthy participants and participants with psoriasis. The study drug will be administered either subcutaneously (SC) (under the skin) or intravenously (IV) (into a vein in the arm).\n\nThis is a three-part study. Participants will enroll in only one part. Parts A and B are for healthy participants and Part C is for participants with psoriasis. Participation could last between 16 and 57 weeks.",null,"A Phase 1 Randomized, Placebo-Controlled Study of LY3316531 in Healthy Subjects and an Open-Label, Single-Dose Study in Patients With Psoriasis",16666,"Psoriasis","Psoriasis","Dermatological Diseases","Derm & Connective Tissue Disorders","Experimental|Placebo Comparator","LY3316531 (Part A)|Placebo (Part A)|LY3316531 (Part B)|Placebo (Part B)|LY3316531 (Part C)","LY3316531 administered IV and/or SC.|Placebo matching LY3316531 administered IV.|Placebo matching LY3316531 administered IV and/or SC.","Drug","LY3316531 - IV|LY3316531 - SC|Placebo - IV|Placebo - SC","Administered IV.|Administered SC.|Placebo - SC.",null,"LY3316531 (Part A)|Placebo (Part A)|LY3316531 (Part B)|Placebo (Part B)|LY3316531 (Part C)","\n\n * Healthy Participants * Are overtly healthy males or females, as determined by medical history and physical examination\n    * Females must be of non-childbearing potential\n    * Are between 18 and 64 years of age, inclusive, at screening\n    * Have a body mass index of 18.0 to 32.0 kilograms per meter squared (kg/mÂ²) inclusive\n    * Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures\n   \n   \n * Psoriasis Participants: * Chronic plaque psoriasis based on an investigator confirmed diagnosis of chronic psoriasis vulgaris for at least 6 months prior to baseline\n    * Meet psoriasis disease activity criteria\n    * Are at least 18 years of age\n    * Have a minimum body weight of 50 kilograms (kg)\n   \n   \n\n","\n\n * Healthy and Psoriasis Participants * Have known or ongoing neuropsychiatric disorders\n    * Have received live vaccine(s) (included attenuated live vaccines) within 28 days of screening or intend to during the study\n    * Have had any malignancy within the past 5 years except for basal cell or squamous cell epithelial carcinomas of the skin that have been resected with no subsequent evidence of recurrence for at least 3 years prior to screening and cervical carcinoma in situ with no evidence of recurrence within 5 years prior to baseline\n    * Show evidence of active or latent tuberculosis (TB)\n    * Have presence of significant uncontrolled cerebro-cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, neurologic or neuropsychiatric disorders or abnormal laboratory values at screening that, in the opinion of the investigator, pose an unacceptable risk to the participant if participating in the study or of interfering with the interpretation of data\n   \n   \n * Psoriasis Participants Only: * Have received treatment with biologic therapies for psoriasis (such as monoclonal antibodies, including marketed or investigational biologic therapy)\n    * Prior or current use of biologics for indications other than psoriasis may be allowed with sponsor approval\n    * Have received systemic nonbiologic psoriasis therapy within 28 days of baseline\n    * Have received topical psoriasis treatment within 14 days of baseline",{"$nulls":4},"Actual","2018-02-01","Actual","Anticipated","2019-09-02","Anticipated","2019-01-11","2018-01-26","2018-01-26","2019-01-14","No",null,"Interventional","Basic Science","Parallel Assignment","Double (Participant, Investigator)","Randomized","18 Years","64 Years","All",null,"Yes",null,null,"URL: https://www.lillytrialguide.com/en-US/studies/psoriasis/FFAA#?postal= [https://www.lillytrialguide.com/en-US/studies/psoriasis/FFAA#?postal=] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: A Study of LY3316531 in Healthy Participants and in Participants With Psoriasis",null,"Yes","No",{"$nulls":17},"I9H-MC-FFAA","Eli Lilly and Company","Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration","A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module","Pre-dose up to 1 year after administration of study drug","Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3316531|PK: Area Under the Concentration Versus Time Curve (AUC) of LY3316531","PK: Cmax of LY3316531|PK: AUC of LY3316531","Pre-dose up to 1 year after administration of study drug",{"$nulls":3},"Glendale, California, United States, 91206-4140|Baltimore, Maryland, United States, 21225","California|Maryland","United States","Parexel Early Phase Unit At Glendale|Parexel-Phase 1 Baltimore Harbor Hospital Center",{"$nulls":3},"Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)","2019-01-14","2020-05-25T16:39:56.695","2020-05-26T17:10:42.972","NCT03418493"]
["5ecbf4dd307e3d1b1f8d9e7f","NCT03418493","2019-07-16","Eli Lilly","LLY","Active, not recruiting","A Study of LY3316531 in Healthy Participants and in Participants With Psoriasis","Ly-3316531",null,"Yes","['Ly-3316531']","Unknown",null,"Phase 1",5,102,"Anticipated","2018-01-30","2018-12-24",{"$nulls":5},"The purpose of this study is to evaluate how well LY3316531 is tolerated and what side effects may occur in healthy participants and participants with psoriasis. The study drug will be administered either subcutaneously (SC) (under the skin) or intravenously (IV) (into a vein in the arm).\n\nThis is a three-part study. Participants will enroll in only one part. Parts A and B are for healthy participants and Part C is for participants with psoriasis. Participation could last between 16 and 57 weeks.",null,"A Phase 1 Randomized, Placebo-Controlled Study of LY3316531 in Healthy Subjects and an Open-Label, Single-Dose Study in Patients With Psoriasis",16666,"Psoriasis","Psoriasis","Dermatological Diseases","Derm & Connective Tissue Disorders","Experimental|Placebo Comparator","LY3316531 (Part A)|Placebo (Part A)|LY3316531 (Part B)|Placebo (Part B)|LY3316531 (Part C)","LY3316531 administered IV and/or SC.|Placebo matching LY3316531 administered IV.|Placebo matching LY3316531 administered IV and/or SC.","Drug","LY3316531 - IV|LY3316531 - SC|Placebo - IV|Placebo - SC","Administered IV.|Administered SC.|Placebo - SC.",null,"LY3316531 (Part A)|Placebo (Part A)|LY3316531 (Part B)|Placebo (Part B)|LY3316531 (Part C)","\n\n * Healthy Participants * Are overtly healthy males or females, as determined by medical history and physical examination\n    * Females must be of non-childbearing potential\n    * Are between 18 and 64 years of age, inclusive, at screening\n    * Have a body mass index of 18.0 to 32.0 kilograms per meter squared (kg/mÂ²) inclusive\n    * Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures\n   \n   \n * Psoriasis Participants: * Chronic plaque psoriasis based on an investigator confirmed diagnosis of chronic psoriasis vulgaris for at least 6 months prior to baseline\n    * Meet psoriasis disease activity criteria\n    * Are at least 18 years of age\n    * Have a minimum body weight of 50 kilograms (kg)\n   \n   \n\n","\n\n * Healthy and Psoriasis Participants * Have known or ongoing neuropsychiatric disorders\n    * Have received live vaccine(s) (included attenuated live vaccines) within 28 days of screening or intend to during the study\n    * Have had any malignancy within the past 5 years except for basal cell or squamous cell epithelial carcinomas of the skin that have been resected with no subsequent evidence of recurrence for at least 3 years prior to screening and cervical carcinoma in situ with no evidence of recurrence within 5 years prior to baseline\n    * Show evidence of active or latent tuberculosis (TB)\n    * Have presence of significant uncontrolled cerebro-cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, neurologic or neuropsychiatric disorders or abnormal laboratory values at screening that, in the opinion of the investigator, pose an unacceptable risk to the participant if participating in the study or of interfering with the interpretation of data\n   \n   \n * Psoriasis Participants Only: * Have received treatment with biologic therapies for psoriasis (such as monoclonal antibodies, including marketed or investigational biologic therapy)\n    * Prior or current use of biologics for indications other than psoriasis may be allowed with sponsor approval\n    * Have received systemic nonbiologic psoriasis therapy within 28 days of baseline\n    * Have received topical psoriasis treatment within 14 days of baseline",{"$nulls":4},"Actual","2018-02-01","Actual","Actual","2019-08-02","Anticipated","2019-07-15","2018-01-26","2018-01-26","2019-07-15","No",null,"Interventional","Basic Science","Parallel Assignment","Double (Participant, Investigator)","Randomized","18 Years","64 Years","All",null,"Yes",null,null,"URL: https://www.lillytrialguide.com/en-US/studies/psoriasis/FFAA#?postal= [https://www.lillytrialguide.com/en-US/studies/psoriasis/FFAA#?postal=] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: A Study of LY3316531 in Healthy Participants and in Participants With Psoriasis",null,"Yes","No",{"$nulls":17},"I9H-MC-FFAA","Eli Lilly and Company","Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration","A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module","Pre-dose up to 1 year after administration of study drug","Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3316531|PK: Area Under the Concentration Versus Time Curve (AUC) of LY3316531","PK: Cmax of LY3316531|PK: AUC of LY3316531","Pre-dose up to 1 year after administration of study drug",{"$nulls":3},"Glendale, California, United States, 91206-4140|Baltimore, Maryland, United States, 21225","California|Maryland","United States","Parexel Early Phase Unit At Glendale|Parexel-Phase 1 Baltimore Harbor Hospital Center",{"$nulls":3},"Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)","2019-07-15","2020-05-25T16:39:57.118","2020-05-26T17:10:42.972","NCT03418493"]
["5ecbf4df11702c1b1b916bff","NCT03418532","2018-02-01","Molecular Partners AG","MLLCF","Not yet recruiting","MP0250 DARPinÂ® Protein Plus Osimertinib in Patients With EGFR-mutated NSCLC","Mp-0250|Osimertinib","EGFR Inhibitor|TK Inhibitor|ERBB2 Inhibitor","Yes","['Mp-0250']","No",null,"Phase 1/Phase 2",1,40,"Anticipated","2018-02-01","2020-03-01","RR","Response Rate",{"$nulls":3},"The purpose of this study is to assess the anti-tumor efficacy, safety, tolerability, pharmacokinetics (PK), immunogenicity and biological activity of the MP0250 DARPinÂ® drug candidate in combination with osimertinib orally once daily (o.d.), when administered to patients with EGFR mutated, advanced, non squamous NSCLC after tumor progression on osimertinib and on or after the most recent therapy.\n\nMP0250 is a multi-DARPinÂ® protein with three specificities, able to simultaneously neutralize the activities of vascular endothelial growth factor (VEGF) and hepatocyte growth factor (HGF) and also to bind to human serum albumin (HSA) to give an increased plasma half-life and potentially enhanced tumor penetration.",null,"A Phase 1b/2, Single-arm, Open-label, Multi-center Study of MP0250 in Combination With Osimertinib in Patients With EGFR-mutated Non-squamous Non-small Cell Lung Cancer (NSCLC) Pretreated With Osimertinib","MP0250-CP202","EGFR-mutated NSCLC (Disorder)","Non-Small-Cell Lung Cancer","Oncology Solid Tumor","Oncology","Experimental","single arm","MP0250 DARPinÂ® drug candidate (6 mg/kg or 8 mg/kg or 12 mg/kg, infusion) on day 1 of each 21 day cycle. Osimertinib according to label",null,"Combination Product: MP0250 DARPin&#xAE; drug candidate, Osimertinib","Number of Cycles: until progression, unacceptable toxicity or other reasons for withdrawal",null,"single arm","\n\n 1. Histologically confirmed metastatic or unresectable locally advanced non-squamous NSCLC with documented EGFR mutation-positive disease\n 2. Radiologically documented disease progression on previous osimertinib treatment.\n 3. Radiologically documented disease progression on or after most recent antitumor therapy.\n 4. Measurable disease according to RECIST 1.1.\n 5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 2.\n 6. Men and women â‰¥18 years old on the day of signing informed consent.\n 7. Adequate hematological, hepatic and renal function prior to first dose\n 8. Serum albumin concentration â‰¥30 g/L\n 9. Potassium and magnesium within normal range\n\n","\n\n 1.  Necrotic tumors or tumors close to large blood vessels that may impose an increased bleeding risk when treated with anti-VEGF agents.\n 2.  Second malignancy that is currently clinically significant or required active intervention during the period of 12 months prior to Screening, except early stage non-melanoma skin cancer treated with curative intent.\n 3.  Known pre-existing interstitial or inflammatory lung disease.\n 4.  Clinical signs of or documented leptomeningeal carcinomatosis. Features such as headache, nuchal rigidity, and photophobia may indicate meningeal involvement.\n 5.  Known brain metastases who are clinically unstable\n 6.  Prohibited anti-NSCLC therapies and not having recovered from related AEs to Common Terminology Criteria for Adverse Events (CTCAE) Grade â‰¤1\n 7.  Any investigational drug within 28 days prior to study treatment.\n 8.  Current participation in any other interventional clinical study (except survival follow up).\n 9.  Neuropathy as residual toxicity after prior antitumor therapy Grade >2\n 10. Patients taking medications that have the potential to prolong the QT interval\n 11. Significant cardiac abnormalities\n 12. Uncontrolled hypertension\n 13. Significant risk for bleeding\n 14. Active or recent thrombolic events","EGFR|HGF","epidermal growth factor receptor|hepatocyte growth factor","Protein","Ovary, Breast, Lung|Liver, Breast","Actual","2018-02-01","Actual","Anticipated","2020-06-01","Anticipated","2018-01-01","2018-01-10","2018-01-31","2018-01-31","No","DARPinÂ®protein\nMP0250\nVEGF\nHGF\nNSCLC\nEGFR mutated\nOsimertinib","Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":19},"Estimate the objective response rate (ORR)","Tumor response will be assessed based on RECIST 1.1 by using CT or MRI","6 months","Incidence and severity of treatment-emergent adverse events (TEAEs) graded according to CTCAE, v4.03.|progression free survival (PFS)|duration of response (DOR)|overall survival (OS)|time to response (TTR)|Incidence of anti-drug (MP0250) antibody formation|pharmacokinetics|Other Pre-specified Outcome Measures:|biomarkers in tissue|biomarkers in blood","number of patients with AE/SAE on the base of CTCAE (version 4.03)|PFS according to RECIST 1.1|DOR according to RECIST 1.1|time from the date of first dose of MP0250 until death from any cause or until 1 year for all patients|TTR according to RECIST 1.1|determined as titer of anti-drug antibodies|half-life|clearance|AUC|Cmax|Other Pre-specified Outcome Measures:|biomarkers associated with response or resistance to MP0250, HGF by IHC|biomarkers associated with response or resistance to MP0250, HGF by ELISA","15 months|12 months|9 months|24 months|4 months","info@molecularpartners.com","Medical Director Molecular Partners","+41 44 755 7700",{"$nulls":8},"2018-01-31","2020-05-25T16:39:59.107","2020-05-26T17:10:42.972","NCT03418532"]
["5ecbf4dfe2561b1b11905eed","NCT03418532","2018-07-02","Molecular Partners AG","MLLCF","Recruiting","MP0250 DARPinÂ® Protein Plus Osimertinib in Patients With EGFR-mutated NSCLC","Mp-0250|Osimertinib","EGFR Inhibitor|TK Inhibitor|ERBB2 Inhibitor","Yes","['Mp-0250']","No",null,"Phase 1/Phase 2",1,40,"Anticipated","2018-03-01","2020-03-01","RR","Response Rate",{"$nulls":3},"The purpose of this study is to assess the anti-tumor efficacy, safety, tolerability, pharmacokinetics (PK), immunogenicity and biological activity of the MP0250 DARPinÂ® drug candidate in combination with osimertinib orally once daily (o.d.), when administered to patients with EGFR mutated, advanced, non squamous NSCLC after tumor progression on osimertinib and on or after the most recent therapy.\n\nMP0250 is a multi-DARPinÂ® protein with three specificities, able to simultaneously neutralize the activities of vascular endothelial growth factor (VEGF) and hepatocyte growth factor (HGF) and also to bind to human serum albumin (HSA) to give an increased plasma half-life and potentially enhanced tumor penetration.",null,"A Phase 1b/2, Single-arm, Open-label, Multi-center Study of MP0250 in Combination With Osimertinib in Patients With EGFR-mutated Non-squamous Non-small Cell Lung Cancer (NSCLC) Pretreated With Osimertinib","MP0250-CP202","EGFR-mutated NSCLC (Disorder)","Non-Small-Cell Lung Cancer","Oncology Solid Tumor","Oncology","Experimental","single arm","MP0250 DARPinÂ® drug candidate (6 mg/kg or 8 mg/kg or 12 mg/kg, infusion) on day 1 of each 21 day cycle. Osimertinib according to label",null,"Combination Product: MP0250 DARPin&#xAE; drug candidate, Osimertinib","Number of Cycles: until progression, unacceptable toxicity or other reasons for withdrawal",null,"single arm","\n\n 1. Histologically confirmed metastatic or unresectable locally advanced non-squamous NSCLC with documented EGFR mutation-positive disease\n 2. Radiologically documented disease progression on previous osimertinib treatment.\n 3. Radiologically documented disease progression on or after most recent antitumor therapy.\n 4. Measurable disease according to RECIST 1.1.\n 5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 2.\n 6. Men and women â‰¥18 years old on the day of signing informed consent.\n 7. Adequate hematological, hepatic and renal function prior to first dose\n 8. Serum albumin concentration â‰¥30 g/L\n 9. Potassium and magnesium within normal range\n\n","\n\n 1.  Necrotic tumors or tumors close to large blood vessels that may impose an increased bleeding risk when treated with anti-VEGF agents.\n 2.  Second malignancy that is currently clinically significant or required active intervention during the period of 12 months prior to Screening, except early stage non-melanoma skin cancer treated with curative intent.\n 3.  Known pre-existing interstitial or inflammatory lung disease.\n 4.  Clinical signs of or documented leptomeningeal carcinomatosis. Features such as headache, nuchal rigidity, and photophobia may indicate meningeal involvement.\n 5.  Known brain metastases who are clinically unstable\n 6.  Prohibited anti-NSCLC therapies and not having recovered from related AEs to Common Terminology Criteria for Adverse Events (CTCAE) Grade â‰¤1\n 7.  Any investigational drug within 28 days prior to study treatment.\n 8.  Current participation in any other interventional clinical study (except survival follow up).\n 9.  Neuropathy as residual toxicity after prior antitumor therapy Grade >2\n 10. Patients taking medications that have the potential to prolong the QT interval\n 11. Significant cardiac abnormalities\n 12. Uncontrolled hypertension\n 13. Significant risk for bleeding\n 14. Active or recent thrombolic events","EGFR|HGF","epidermal growth factor receptor|hepatocyte growth factor","Protein","Ovary, Breast, Lung|Liver, Breast","Actual","2018-02-01","Actual","Anticipated","2020-06-01","Anticipated","2018-03-01","2018-01-10","2018-01-31","2018-06-29","No","DARPinÂ®protein\nMP0250\nVEGF\nHGF\nNSCLC\nEGFR mutated\nOsimertinib","Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":19},"Estimate the objective response rate (ORR)","Tumor response will be assessed based on RECIST 1.1 by using CT or MRI","6 months","Incidence and severity of treatment-emergent adverse events (TEAEs) graded according to CTCAE, v4.03.|progression free survival (PFS)|duration of response (DOR)|overall survival (OS)|time to response (TTR)|Incidence of anti-drug (MP0250) antibody formation|pharmacokinetics|Other Pre-specified Outcome Measures:|biomarkers in tissue|biomarkers in blood","number of patients with AE/SAE on the base of CTCAE (version 4.03)|PFS according to RECIST 1.1|DOR according to RECIST 1.1|time from the date of first dose of MP0250 until death from any cause or until 1 year for all patients|TTR according to RECIST 1.1|determined as titer of anti-drug antibodies|half-life|clearance|AUC|Cmax|Other Pre-specified Outcome Measures:|biomarkers associated with response or resistance to MP0250, HGF by IHC|biomarkers associated with response or resistance to MP0250, HGF by ELISA","15 months|12 months|9 months|24 months|4 months","info@molecularpartners.com","Medical Director Molecular Partners","+41 44 755 7700","Scottsdale, Arizona, United States, 85258 United States, District Of Columbia Georgetown UniversityWashington, District Of Columbia, United States, 20057|Orlando, Florida, United States, 32803|Houston, Texas, United States, 77030","Arizona|Florida|Texas","United States","Scottsdale Healthcare Hospitals|Florida Hospital|Oncology Consultants",{"$nulls":4},"2018-06-29","2020-05-25T16:39:59.022","2020-05-26T17:10:42.972","NCT03418532"]
["5ecbf4dffeab101b15530a22","NCT03418532","2018-08-14","Molecular Partners AG","MLLCF","Recruiting","MP0250 DARPinÂ® Protein Plus Osimertinib in Patients With EGFR-mutated NSCLC","Mp-0250|Osimertinib","EGFR Inhibitor|TK Inhibitor|ERBB2 Inhibitor","Yes","['Mp-0250']","No",null,"Phase 1/Phase 2",1,40,"Anticipated","2018-03-01","2020-03-01","RR","Response Rate",{"$nulls":3},"The purpose of this study is to assess the anti-tumor efficacy, safety, tolerability, pharmacokinetics (PK), immunogenicity and biological activity of the MP0250 DARPinÂ® drug candidate in combination with osimertinib orally once daily (o.d.), when administered to patients with EGFR mutated, advanced, non squamous NSCLC after tumor progression on osimertinib and on or after the most recent therapy.\n\nMP0250 is a multi-DARPinÂ® protein with three specificities, able to simultaneously neutralize the activities of vascular endothelial growth factor (VEGF) and hepatocyte growth factor (HGF) and also to bind to human serum albumin (HSA) to give an increased plasma half-life and potentially enhanced tumor penetration.",null,"A Phase 1b/2, Single-arm, Open-label, Multi-center Study of MP0250 in Combination With Osimertinib in Patients With EGFR-mutated Non-squamous Non-small Cell Lung Cancer (NSCLC) Pretreated With Osimertinib","MP0250-CP202","EGFR-mutated NSCLC (Disorder)","Non-Small-Cell Lung Cancer","Oncology Solid Tumor","Oncology","Experimental","single arm","MP0250 DARPinÂ® drug candidate (6 mg/kg or 8 mg/kg or 12 mg/kg, infusion) on day 1 of each 21 day cycle. Osimertinib according to label",null,"Combination Product: MP0250 DARPin&#xAE; drug candidate, Osimertinib","Number of Cycles: until progression, unacceptable toxicity or other reasons for withdrawal",null,"single arm","\n\n 1. Histologically confirmed metastatic or unresectable locally advanced non-squamous NSCLC with documented EGFR mutation-positive disease\n 2. Radiologically documented disease progression on previous osimertinib treatment.\n 3. Radiologically documented disease progression on or after most recent antitumor therapy.\n 4. Measurable disease according to RECIST 1.1.\n 5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 2.\n 6. Men and women â‰¥18 years old on the day of signing informed consent.\n 7. Adequate hematological, hepatic and renal function prior to first dose\n 8. Serum albumin concentration â‰¥30 g/L\n 9. Potassium and magnesium within normal range\n\n","\n\n 1.  Necrotic tumors or tumors close to large blood vessels that may impose an increased bleeding risk when treated with anti-VEGF agents.\n 2.  Second malignancy that is currently clinically significant or required active intervention during the period of 12 months prior to Screening, except early stage non-melanoma skin cancer treated with curative intent.\n 3.  Known pre-existing interstitial or inflammatory lung disease.\n 4.  Clinical signs of or documented leptomeningeal carcinomatosis. Features such as headache, nuchal rigidity, and photophobia may indicate meningeal involvement.\n 5.  Known brain metastases who are clinically unstable\n 6.  Prohibited anti-NSCLC therapies and not having recovered from related AEs to Common Terminology Criteria for Adverse Events (CTCAE) Grade â‰¤1\n 7.  Any investigational drug within 28 days prior to study treatment.\n 8.  Current participation in any other interventional clinical study (except survival follow up).\n 9.  Neuropathy as residual toxicity after prior antitumor therapy Grade >2\n 10. Patients taking medications that have the potential to prolong the QT interval\n 11. Significant cardiac abnormalities\n 12. Uncontrolled hypertension\n 13. Significant risk for bleeding\n 14. Active or recent thrombolic events","EGFR|HGF","epidermal growth factor receptor|hepatocyte growth factor","Protein","Ovary, Breast, Lung|Liver, Breast","Actual","2018-02-01","Actual","Anticipated","2020-06-01","Anticipated","2018-03-01","2018-01-10","2018-01-31","2018-08-13","No","DARPinÂ®protein\nMP0250\nVEGF\nHGF\nNSCLC\nEGFR mutated\nOsimertinib","Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":19},"Estimate the objective response rate (ORR)","Tumor response will be assessed based on RECIST 1.1 by using CT or MRI","6 months","Incidence and severity of treatment-emergent adverse events (TEAEs) graded according to CTCAE, v4.03.|progression free survival (PFS)|duration of response (DOR)|overall survival (OS)|time to response (TTR)|Incidence of anti-drug (MP0250) antibody formation|pharmacokinetics|Other Pre-specified Outcome Measures:|biomarkers in tissue|biomarkers in blood","number of patients with AE/SAE on the base of CTCAE (version 4.03)|PFS according to RECIST 1.1|DOR according to RECIST 1.1|time from the date of first dose of MP0250 until death from any cause or until 1 year for all patients|TTR according to RECIST 1.1|determined as titer of anti-drug antibodies|half-life|clearance|AUC|Cmax|Other Pre-specified Outcome Measures:|biomarkers associated with response or resistance to MP0250, HGF by IHC|biomarkers associated with response or resistance to MP0250, HGF by ELISA","15 months|12 months|9 months|24 months|4 months","info@molecularpartners.com","Medical Director Molecular Partners","+41 44 755 7700","Scottsdale, Arizona, United States, 85258|San Diego, California, United States, 92093 United States, District Of Columbia Georgetown UniversityWashington, District Of Columbia, United States, 20057|Orlando, Florida, United States, 32803|Durham, North Carolina, United States, 27710|Dallas, Texas, United States, 75390 Oncology ConsultantsHouston, Texas, United States, 77030","Arizona|California|Florida|North Carolina|Texas","United States","Scottsdale Healthcare Hospitals|University Of California|Florida Hospital|Duke Cancer Institute|Ut Southwestern Medical Center",{"$nulls":4},"2018-08-13","2020-05-25T16:39:59.060","2020-05-26T17:10:42.972","NCT03418532"]
["5ecbf4dffe30261b1a0483f4","NCT03418532","2018-11-30","Molecular Partners AG","MLLCF","Recruiting","A Phase 1b/2 Trial of MP0250 DARPinÂ® Protein Plus Osimertinib in Patients With EGFR-mutated NSCLC","Mp-0250|Osimertinib","EGFR Inhibitor|TK Inhibitor|ERBB2 Inhibitor","Yes","['Mp-0250']","No",null,"Phase 1/Phase 2",1,40,"Anticipated","2018-03-22","2021-04-01","RR","Response Rate",{"$nulls":3},"The purpose of this study is to assess the anti-tumor efficacy, safety, tolerability, pharmacokinetics (PK), immunogenicity and biological activity of the MP0250 DARPinÂ® drug candidate in combination with osimertinib orally once daily (o.d.), when administered to patients with EGFR mutated, advanced, non squamous NSCLC after tumor progression on osimertinib and on or after the most recent therapy.\n\nMP0250 is a multi-DARPinÂ® protein with three specificities, able to simultaneously neutralize the activities of vascular endothelial growth factor (VEGF) and hepatocyte growth factor (HGF) and also to bind to human serum albumin (HSA) to give an increased plasma half-life and potentially enhanced tumor penetration.",null,"A Phase 1b/2, Single-arm, Open-label, Multi-center Study of MP0250 in Combination With Osimertinib in Patients With EGFR-mutated Non-squamous Non-small Cell Lung Cancer (NSCLC) Pretreated With Osimertinib","MP0250-CP202","EGFR-mutated NSCLC (Disorder)","Non-Small-Cell Lung Cancer","Oncology Solid Tumor","Oncology","Experimental","single arm","MP0250 DARPinÂ® drug candidate (6 mg/kg or 8 mg/kg or 12 mg/kg, infusion) on day 1 of each 21 day cycle. Osimertinib according to label",null,"Combination Product: MP0250 DARPin&#xAE; drug candidate, Osimertinib","Number of Cycles: until progression, unacceptable toxicity or other reasons for withdrawal",null,"single arm","\n\n 1. Histologically confirmed metastatic or unresectable locally advanced non-squamous NSCLC with documented EGFR mutation-positive disease\n 2. Radiologically documented disease progression on previous osimertinib treatment.\n 3. Radiologically documented disease progression on or after most recent antitumor therapy.\n 4. Measurable disease according to RECIST 1.1.\n 5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 2.\n 6. Men and women â‰¥18 years old on the day of signing informed consent.\n 7. Adequate hematological, hepatic and renal function prior to first dose\n 8. Serum albumin concentration â‰¥30 g/L\n 9. Potassium and magnesium within normal range\n\n","\n\n 1.  Necrotic tumors or tumors close to large blood vessels that may impose an increased bleeding risk when treated with anti-VEGF agents.\n 2.  Second malignancy that is currently clinically significant or required active intervention during the period of 12 months prior to Screening, except early stage non-melanoma skin cancer treated with curative intent.\n 3.  Known pre-existing interstitial or inflammatory lung disease.\n 4.  Clinical signs of or documented leptomeningeal carcinomatosis. Features such as headache, nuchal rigidity, and photophobia may indicate meningeal involvement.\n 5.  Known brain metastases who are clinically unstable\n 6.  Prohibited anti-NSCLC therapies and not having recovered from related AEs to Common Terminology Criteria for Adverse Events (CTCAE) Grade â‰¤1\n 7.  Any investigational drug within 28 days prior to study treatment.\n 8.  Current participation in any other interventional clinical study (except survival follow up).\n 9.  Neuropathy as residual toxicity after prior antitumor therapy Grade >2\n 10. Patients taking medications that have the potential to prolong the QT interval\n 11. Significant cardiac abnormalities\n 12. Uncontrolled hypertension\n 13. Significant risk for bleeding\n 14. Active or recent thrombolic events","EGFR|HGF","epidermal growth factor receptor|hepatocyte growth factor","Protein","Ovary, Breast, Lung|Liver, Breast","Actual","2018-02-01","Actual","Anticipated","2021-07-01","Anticipated","2018-11-01","2018-01-10","2018-01-31","2018-11-28","No","DARPinÂ®protein\nMP0250\nVEGF\nHGF\nNSCLC\nEGFR mutated\nOsimertinib","Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":19},"Estimate the objective response rate (ORR)","Tumor response will be assessed based on RECIST 1.1 by using CT or MRI","6 months","Incidence and severity of treatment-emergent adverse events (TEAEs) graded according to CTCAE, v4.03.|progression free survival (PFS)|duration of response (DOR)|overall survival (OS)|time to response (TTR)|Incidence of anti-drug (MP0250) antibody formation|pharmacokinetics|Other Pre-specified Outcome Measures:|biomarkers in tissue|biomarkers in blood","number of patients with AE/SAE on the base of CTCAE (version 4.03)|PFS according to RECIST 1.1|DOR according to RECIST 1.1|time from the date of first dose of MP0250 until death from any cause or until 1 year for all patients|TTR according to RECIST 1.1|determined as titer of anti-drug antibodies|half-life|clearance|AUC|Cmax|Other Pre-specified Outcome Measures:|biomarkers associated with response or resistance to MP0250, HGF by IHC|biomarkers associated with response or resistance to MP0250, HGF by ELISA","15 months|12 months|9 months|24 months|4 months","info@molecularpartners.com","Medical Director Molecular Partners","+41 44 755 7700","Scottsdale, Arizona, United States, 85258|Duarte, California, United States, 91010 University Of CaliforniaSan Diego, California, United States, 92093 United States, District Of Columbia Georgetown UniversityWashington, District Of Columbia, United States, 20057|Orlando, Florida, United States, 32803|Durham, North Carolina, United States, 27710|Dallas, Texas, United States, 75390 Oncology ConsultantsHouston, Texas, United States, 77030","Arizona|California|Florida|North Carolina|Texas","United States","Scottsdale Healthcare Hospitals|City Of Hope - Comprehensive Cancer Center|Florida Hospital|Duke Cancer Institute|Ut Southwestern Medical Center",{"$nulls":4},"2018-11-28","2020-05-25T16:39:59.360","2020-05-26T17:10:42.972","NCT03418532"]
["5ecbf4dfe2561b1b11905eee","NCT03418532","2018-12-04","Molecular Partners AG","MLLCF","Recruiting","MP0250 DARPinÂ® Protein Plus Osimertinib in Patients With EGFR-mutated NSCLC","Mp-0250|Osimertinib","EGFR Inhibitor|TK Inhibitor|ERBB2 Inhibitor","Yes","['Mp-0250']","No",null,"Phase 1/Phase 2",1,40,"Anticipated","2018-03-22","2021-04-01","RR","Response Rate",{"$nulls":3},"The purpose of this study is to assess the anti-tumor efficacy, safety, tolerability, pharmacokinetics (PK), immunogenicity and biological activity of the MP0250 DARPinÂ® drug candidate in combination with osimertinib orally once daily (o.d.), when administered to patients with EGFR mutated, advanced, non squamous NSCLC after tumor progression on osimertinib and on or after the most recent therapy.\n\nMP0250 is a multi-DARPinÂ® protein with three specificities, able to simultaneously neutralize the activities of vascular endothelial growth factor (VEGF) and hepatocyte growth factor (HGF) and also to bind to human serum albumin (HSA) to give an increased plasma half-life and potentially enhanced tumor penetration.",null,"A Phase 1b/2, Single-arm, Open-label, Multi-center Study of MP0250 in Combination With Osimertinib in Patients With EGFR-mutated Non-squamous Non-small Cell Lung Cancer (NSCLC) Pretreated With Osimertinib","MP0250-CP202","EGFR-mutated NSCLC (Disorder)","Non-Small-Cell Lung Cancer","Oncology Solid Tumor","Oncology","Experimental","single arm","MP0250 DARPinÂ® drug candidate (6 mg/kg or 8 mg/kg or 12 mg/kg, infusion) on day 1 of each 21 day cycle. Osimertinib according to label",null,"Combination Product: MP0250 DARPin&#xAE; drug candidate, Osimertinib","Number of Cycles: until progression, unacceptable toxicity or other reasons for withdrawal",null,"single arm","\n\n 1. Histologically confirmed metastatic or unresectable locally advanced non-squamous NSCLC with documented EGFR mutation-positive disease\n 2. Radiologically documented disease progression on previous osimertinib treatment.\n 3. Radiologically documented disease progression on or after most recent antitumor therapy.\n 4. Measurable disease according to RECIST 1.1.\n 5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 2.\n 6. Men and women â‰¥18 years old on the day of signing informed consent.\n 7. Adequate hematological, hepatic and renal function prior to first dose\n 8. Serum albumin concentration â‰¥30 g/L\n 9. Potassium and magnesium within normal range\n\n","\n\n 1.  Necrotic tumors or tumors close to large blood vessels that may impose an increased bleeding risk when treated with anti-VEGF agents.\n 2.  Second malignancy that is currently clinically significant or required active intervention during the period of 12 months prior to Screening, except early stage non-melanoma skin cancer treated with curative intent.\n 3.  Known pre-existing interstitial or inflammatory lung disease.\n 4.  Clinical signs of or documented leptomeningeal carcinomatosis. Features such as headache, nuchal rigidity, and photophobia may indicate meningeal involvement.\n 5.  Known brain metastases who are clinically unstable\n 6.  Prohibited anti-NSCLC therapies and not having recovered from related AEs to Common Terminology Criteria for Adverse Events (CTCAE) Grade â‰¤1\n 7.  Any investigational drug within 28 days prior to study treatment.\n 8.  Current participation in any other interventional clinical study (except survival follow up).\n 9.  Neuropathy as residual toxicity after prior antitumor therapy Grade >2\n 10. Patients taking medications that have the potential to prolong the QT interval\n 11. Significant cardiac abnormalities\n 12. Uncontrolled hypertension\n 13. Significant risk for bleeding\n 14. Active or recent thrombolic events","EGFR|HGF","epidermal growth factor receptor|hepatocyte growth factor","Protein","Ovary, Breast, Lung|Liver, Breast","Actual","2018-02-01","Actual","Anticipated","2021-07-01","Anticipated","2018-11-01","2018-01-10","2018-01-31","2018-11-30","No","DARPinÂ®protein\nMP0250\nVEGF\nHGF\nNSCLC\nEGFR mutated\nOsimertinib","Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":19},"Estimate the objective response rate (ORR)","Tumor response will be assessed based on RECIST 1.1 by using CT or MRI","6 months","Incidence and severity of treatment-emergent adverse events (TEAEs) graded according to CTCAE, v4.03.|progression free survival (PFS)|duration of response (DOR)|overall survival (OS)|time to response (TTR)|Incidence of anti-drug (MP0250) antibody formation|pharmacokinetics|Other Pre-specified Outcome Measures:|biomarkers in tissue|biomarkers in blood","number of patients with AE/SAE on the base of CTCAE (version 4.03)|PFS according to RECIST 1.1|DOR according to RECIST 1.1|time from the date of first dose of MP0250 until death from any cause or until 1 year for all patients|TTR according to RECIST 1.1|determined as titer of anti-drug antibodies|half-life|clearance|AUC|Cmax|Other Pre-specified Outcome Measures:|biomarkers associated with response or resistance to MP0250, HGF by IHC|biomarkers associated with response or resistance to MP0250, HGF by ELISA","15 months|12 months|9 months|24 months|4 months","info@molecularpartners.com","Medical Director Molecular Partners","+41 44 755 7700","Scottsdale, Arizona, United States, 85258|Duarte, California, United States, 91010 University Of CaliforniaSan Diego, California, United States, 92093 United States, District Of Columbia Georgetown UniversityWashington, District Of Columbia, United States, 20057|Orlando, Florida, United States, 32803|Durham, North Carolina, United States, 27710|Dallas, Texas, United States, 75390 Oncology ConsultantsHouston, Texas, United States, 77030","Arizona|California|Florida|North Carolina|Texas","United States","Scottsdale Healthcare Hospitals|City Of Hope - Comprehensive Cancer Center|Florida Hospital|Duke Cancer Institute|Ut Southwestern Medical Center",{"$nulls":4},"2018-11-30","2020-05-25T16:39:59.342","2020-05-26T17:10:42.972","NCT03418532"]
["5ecbf4dffeab101b15530a23","NCT03418532","2019-04-08","Molecular Partners AG","MLLCF","Recruiting","MP0250 DARPinÂ® Protein Plus Osimertinib in Patients With EGFR-mutated NSCLC","Mp-0250|Osimertinib","EGFR Inhibitor|TK Inhibitor|ERBB2 Inhibitor","Yes","['Mp-0250']","No",null,"Phase 1/Phase 2",1,40,"Anticipated","2018-03-22","2021-04-01","RR","Response Rate",{"$nulls":3},"The purpose of this study is to assess the anti-tumor efficacy, safety, tolerability, pharmacokinetics (PK), immunogenicity and biological activity of the MP0250 DARPinÂ® drug candidate in combination with osimertinib orally once daily (o.d.), when administered to patients with EGFR mutated, advanced, non squamous NSCLC after tumor progression on osimertinib and on or after the most recent therapy.\n\nMP0250 is a multi-DARPinÂ® protein with three specificities, able to simultaneously neutralize the activities of vascular endothelial growth factor (VEGF) and hepatocyte growth factor (HGF) and also to bind to human serum albumin (HSA) to give an increased plasma half-life and potentially enhanced tumor penetration.",null,"A Phase 1b/2, Single-arm, Open-label, Multi-center Study of MP0250 in Combination With Osimertinib in Patients With EGFR-mutated Non-squamous Non-small Cell Lung Cancer (NSCLC) Pretreated With Osimertinib","MP0250-CP202","EGFR-mutated NSCLC (Disorder)","Non-Small-Cell Lung Cancer","Oncology Solid Tumor","Oncology","Experimental","single arm","MP0250 DARPinÂ® drug candidate (6 mg/kg or 8 mg/kg or 12 mg/kg, infusion) on day 1 of each 21 day cycle. Osimertinib according to label",null,"Combination Product: MP0250 DARPin&#xAE; drug candidate, Osimertinib","Number of Cycles: until progression, unacceptable toxicity or other reasons for withdrawal",null,"single arm","\n\n 1. Histologically confirmed metastatic or unresectable locally advanced non-squamous NSCLC with documented EGFR mutation-positive disease\n 2. Radiologically documented disease progression on previous osimertinib treatment.\n 3. Radiologically documented disease progression on or after most recent antitumor therapy.\n 4. Measurable disease according to RECIST 1.1.\n 5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 2.\n 6. Men and women â‰¥18 years old on the day of signing informed consent.\n 7. Adequate hematological, hepatic and renal function prior to first dose\n 8. Serum albumin concentration â‰¥30 g/L\n 9. Potassium and magnesium within normal range\n\n","\n\n 1.  Necrotic tumors or tumors close to large blood vessels that may impose an increased bleeding risk when treated with anti-VEGF agents.\n 2.  Second malignancy that is currently clinically significant or required active intervention during the period of 12 months prior to Screening, except early stage non-melanoma skin cancer treated with curative intent.\n 3.  Known pre-existing interstitial or inflammatory lung disease.\n 4.  Clinical signs of or documented leptomeningeal carcinomatosis. Features such as headache, nuchal rigidity, and photophobia may indicate meningeal involvement.\n 5.  Known brain metastases who are clinically unstable\n 6.  Prohibited anti-NSCLC therapies and not having recovered from related AEs to Common Terminology Criteria for Adverse Events (CTCAE) Grade â‰¤1\n 7.  Any investigational drug within 28 days prior to study treatment.\n 8.  Current participation in any other interventional clinical study (except survival follow up).\n 9.  Neuropathy as residual toxicity after prior antitumor therapy Grade >2\n 10. Patients taking medications that have the potential to prolong the QT interval\n 11. Significant cardiac abnormalities\n 12. Uncontrolled hypertension\n 13. Significant risk for bleeding\n 14. Active or recent thrombolic events","EGFR|HGF","epidermal growth factor receptor|hepatocyte growth factor","Protein","Ovary, Breast, Lung|Liver, Breast","Actual","2018-02-01","Actual","Anticipated","2021-07-01","Anticipated","2018-11-01","2018-01-10","2018-01-31","2019-04-05","No","DARPinÂ®protein\nMP0250\nVEGF\nHGF\nNSCLC\nEGFR mutated\nOsimertinib","Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":19},"Estimate the objective response rate (ORR)","Tumor response will be assessed based on RECIST 1.1 by using CT or MRI","6 months","Incidence and severity of treatment-emergent adverse events (TEAEs) graded according to CTCAE, v4.03.|progression free survival (PFS)|duration of response (DOR)|overall survival (OS)|time to response (TTR)|Incidence of anti-drug (MP0250) antibody formation|pharmacokinetics|Other Pre-specified Outcome Measures:|biomarkers in tissue|biomarkers in blood","number of patients with AE/SAE on the base of CTCAE (version 4.03)|PFS according to RECIST 1.1|DOR according to RECIST 1.1|time from the date of first dose of MP0250 until death from any cause or until 1 year for all patients|TTR according to RECIST 1.1|determined as titer of anti-drug antibodies|half-life|clearance|AUC|Cmax|Other Pre-specified Outcome Measures:|biomarkers associated with response or resistance to MP0250, HGF by IHC|biomarkers associated with response or resistance to MP0250, HGF by ELISA","15 months|12 months|9 months|24 months|4 months","info@molecularpartners.com","Medical Director Molecular Partners","+41 44 755 7700","Scottsdale, Arizona, United States, 85258|Duarte, California, United States, 91010 University Of CaliforniaSan Diego, California, United States, 92093 Ucla Medical CenterSanta Monica, California, United States, 90404 United States, District Of Columbia Georgetown UniversityWashington, District Of Columbia, United States, 20057|Orlando, Florida, United States, 32803|Durham, North Carolina, United States, 27710|Nashville, Tennessee, United States, 37203|Dallas, Texas, United States, 75390 Oncology ConsultantsHouston, Texas, United States, 77030","Arizona|California|Florida|North Carolina|Tennessee|Texas","United States","Scottsdale Healthcare Hospitals|City Of Hope - Comprehensive Cancer Center|Florida Hospital|Duke Cancer Institute|Tennessee Oncology|Ut Southwestern Medical Center",{"$nulls":4},"2019-04-05","2020-05-25T16:39:59.550","2020-05-26T17:10:42.972","NCT03418532"]
["5ecbf4df307e3d1b1f8d9e85","NCT03418532","2019-04-19","Molecular Partners AG","MLLCF","Active, not recruiting","MP0250 DARPinÂ® Protein Plus Osimertinib in Patients With EGFR-mutated NSCLC","Mp-0250|Osimertinib","EGFR Inhibitor|TK Inhibitor|ERBB2 Inhibitor","Yes","['Mp-0250']","No",null,"Phase 1/Phase 2",1,40,"Anticipated","2018-03-22","2021-04-01","RR","Response Rate",{"$nulls":3},"The purpose of this study is to assess the anti-tumor efficacy, safety, tolerability, pharmacokinetics (PK), immunogenicity and biological activity of the MP0250 DARPinÂ® drug candidate in combination with osimertinib orally once daily (o.d.), when administered to patients with EGFR mutated, advanced, non squamous NSCLC after tumor progression on osimertinib and on or after the most recent therapy.\n\nMP0250 is a multi-DARPinÂ® protein with three specificities, able to simultaneously neutralize the activities of vascular endothelial growth factor (VEGF) and hepatocyte growth factor (HGF) and also to bind to human serum albumin (HSA) to give an increased plasma half-life and potentially enhanced tumor penetration.",null,"A Phase 1b/2, Single-arm, Open-label, Multi-center Study of MP0250 in Combination With Osimertinib in Patients With EGFR-mutated Non-squamous Non-small Cell Lung Cancer (NSCLC) Pretreated With Osimertinib","MP0250-CP202","EGFR-mutated NSCLC (Disorder)","Non-Small-Cell Lung Cancer","Oncology Solid Tumor","Oncology","Experimental","single arm","MP0250 DARPinÂ® drug candidate (6 mg/kg or 8 mg/kg or 12 mg/kg, infusion) on day 1 of each 21 day cycle. Osimertinib according to label",null,"Combination Product: MP0250 DARPin&#xAE; drug candidate, Osimertinib","Number of Cycles: until progression, unacceptable toxicity or other reasons for withdrawal",null,"single arm","\n\n 1. Histologically confirmed metastatic or unresectable locally advanced non-squamous NSCLC with documented EGFR mutation-positive disease\n 2. Radiologically documented disease progression on previous osimertinib treatment.\n 3. Radiologically documented disease progression on or after most recent antitumor therapy.\n 4. Measurable disease according to RECIST 1.1.\n 5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 2.\n 6. Men and women â‰¥18 years old on the day of signing informed consent.\n 7. Adequate hematological, hepatic and renal function prior to first dose\n 8. Serum albumin concentration â‰¥30 g/L\n 9. Potassium and magnesium within normal range\n\n","\n\n 1.  Necrotic tumors or tumors close to large blood vessels that may impose an increased bleeding risk when treated with anti-VEGF agents.\n 2.  Second malignancy that is currently clinically significant or required active intervention during the period of 12 months prior to Screening, except early stage non-melanoma skin cancer treated with curative intent.\n 3.  Known pre-existing interstitial or inflammatory lung disease.\n 4.  Clinical signs of or documented leptomeningeal carcinomatosis. Features such as headache, nuchal rigidity, and photophobia may indicate meningeal involvement.\n 5.  Known brain metastases who are clinically unstable\n 6.  Prohibited anti-NSCLC therapies and not having recovered from related AEs to Common Terminology Criteria for Adverse Events (CTCAE) Grade â‰¤1\n 7.  Any investigational drug within 28 days prior to study treatment.\n 8.  Current participation in any other interventional clinical study (except survival follow up).\n 9.  Neuropathy as residual toxicity after prior antitumor therapy Grade >2\n 10. Patients taking medications that have the potential to prolong the QT interval\n 11. Significant cardiac abnormalities\n 12. Uncontrolled hypertension\n 13. Significant risk for bleeding\n 14. Active or recent thrombolic events","EGFR|HGF","epidermal growth factor receptor|hepatocyte growth factor","Protein","Ovary, Breast, Lung|Liver, Breast","Actual","2018-02-01","Actual","Anticipated","2021-07-01","Anticipated","2019-04-01","2018-01-10","2018-01-31","2019-04-18","No","DARPinÂ®protein\nMP0250\nVEGF\nHGF\nNSCLC\nEGFR mutated\nOsimertinib","Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":19},"Estimate the objective response rate (ORR)","Tumor response will be assessed based on RECIST 1.1 by using CT or MRI","6 months","Incidence and severity of treatment-emergent adverse events (TEAEs) graded according to CTCAE, v4.03.|progression free survival (PFS)|duration of response (DOR)|overall survival (OS)|time to response (TTR)|Incidence of anti-drug (MP0250) antibody formation|pharmacokinetics|Other Pre-specified Outcome Measures:|biomarkers in tissue|biomarkers in blood","number of patients with AE/SAE on the base of CTCAE (version 4.03)|PFS according to RECIST 1.1|DOR according to RECIST 1.1|time from the date of first dose of MP0250 until death from any cause or until 1 year for all patients|TTR according to RECIST 1.1|determined as titer of anti-drug antibodies|half-life|clearance|AUC|Cmax|Other Pre-specified Outcome Measures:|biomarkers associated with response or resistance to MP0250, HGF by IHC|biomarkers associated with response or resistance to MP0250, HGF by ELISA","15 months|12 months|9 months|24 months|4 months",{"$nulls":3},"Scottsdale, Arizona, United States, 85258|Duarte, California, United States, 91010 University Of CaliforniaSan Diego, California, United States, 92093 Ucla Medical CenterSanta Monica, California, United States, 90404 United States, District Of Columbia Georgetown UniversityWashington, District Of Columbia, United States, 20057|Orlando, Florida, United States, 32803|Durham, North Carolina, United States, 27710|Nashville, Tennessee, United States, 37203|Dallas, Texas, United States, 75390 Oncology ConsultantsHouston, Texas, United States, 77030","Arizona|California|Florida|North Carolina|Tennessee|Texas","United States","Scottsdale Healthcare Hospitals|City Of Hope - Comprehensive Cancer Center|Florida Hospital|Duke Cancer Institute|Tennessee Oncology|Ut Southwestern Medical Center",{"$nulls":4},"2019-04-18","2020-05-25T16:39:59.511","2020-05-26T17:10:42.972","NCT03418532"]
["5ecbf4df11702c1b1b916c00","NCT03418571","2018-02-01","Ablynx","ABLX","Not yet recruiting","Evaluation of ALX-0171 in Japanese Children Hospitalized for Respiratory Syncytial Virus Lower Respiratory Tract Infection","Alx-0171",null,"Yes","['Alx-0171']","Unknown",null,"Phase 2",5,60,"Anticipated","2018-02-01","2019-05-01",{"$nulls":5},"The objectives of this study are:\n\n * to evaluate the safety, tolerability, and systemic pharmacokinetics (PK) of different doses of inhaled ALX-0171 in Japanese infants and young children hospitalized for respiratory syncytial virus (RSV) lower respiratory tract infection (LRTI).\n * to evaluate the antiviral effect, clinical activity, immunogenicity, and pharmacodynamics (PD) of different doses of inhaled ALX-0171 in Japanese infants and young children hospitalized for RSV LRTI.",null,"A Randomized, Double-blind, Multicenter, Multiple-dose Study of ALX-0171 Versus Placebo Along With Standard of Care in Japanese Infants and Young Children Hospitalized for Respiratory Syncytial Virus Lower Respiratory Tract Infection","ALX0171-C203","Respiratory Syncytial Virus Lower Respiratory Tract Infection","Other","Other","Other","Experimental|Placebo Comparator","ALX-0171 Dose 1|ALX-0171 Dose 2|ALX-0171 Dose 3|ALX-0171 Dose 4|Placebo",null,"Biological|Drug","ALX-0171 Dose 1|ALX-0171 Dose 2|ALX-0171 Dose 3|ALX0171 Dose 4|Placebo","Inhalation of ALX-0171 Dose 1 once daily for 3 consecutive days|Inhalation of ALX-0171 Dose 2 once daily for 3 consecutive days|Inhalation of ALX-0171 Dose 3 once daily for 3 consecutive days|Inhalation of ALX-0171 Dose 4 once daily for 3 consecutive days|Inhalation of Placebo once daily for 3 consecutive days",null,"ALX-0171 Dose 1|ALX-0171 Dose 2|ALX-0171 Dose 3|ALX-0171 Dose 4|Placebo","\n\n * Subject is of Japanese descent, i.e., born in Japan to Japanese parents and has Japanese maternal and paternal grandparents.\n * Subject is otherwise healthy, but is hospitalized for and clinically diagnosed with RSV LRTI\n * Subject has a positive RSV diagnostic test.\n * Symptoms likely related to RSV infection have appeared within 4 days of screening and are not yet improving\n\nOthers as defined in the protocol\n\n","\n\n * Subject is known to have significant comorbidities\n * Subject is known to be immunocompromised\n * Subject has or is suspected to have an active, clinically relevant concurrent infection\n * Subject received invasive mechanical ventilation or non-invasive respiratory support (i.e., continuous or bilevel positive airway pressure) in the 4 weeks prior to screening.\n\nOthers as defined in the protocol",{"$nulls":4},"Actual","2018-02-01","Actual","Anticipated","2019-05-01","Anticipated","2018-01-01","2018-01-26","2018-01-26","2018-01-26","Yes",null,"Interventional","Treatment","Sequential Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized",null,"2 Years","All",null,"No","No",{"$nulls":3},"No","No",{"$nulls":4},"No",{"$nulls":14},"Safety and tolerability as measured by the incidence of treatment-emergent (serious) adverse events","From time of first dose to 28 days after first dose",null,"Pharmacokinetics as measured by the concentration of ALX-0171 in serum|Time for viral load to drop below assay quantification limit (BQL)|Global Severity Score|Time to Clinical Response|Immunogenicity as measured by the concentration of anti-ALX 0171 antibodies in serum","Day 2 - Day 3|Time needed for the viral load to drop below the assay quantification limit (time-to-BQL) in nasal swab specimens.|Evolution over time in Global Severity Score|Evaluation of the clinical response of the subjects as defined in the protocol|From day of first dose to 28 days after first dose","From day of first dose to 14 days after first dose|From day of first dose to 28 days after first dose","clinicaltrials@ablynx.com","Ablynx NV Belgium","+32 9 262 00 00",{"$nulls":7},"Ablynx Clinical Department","2018-01-26","2020-05-25T16:39:59.551","2020-05-26T17:10:42.972","NCT03418571"]
["5ecbf4e011702c1b1b916c01","NCT03418571","2018-02-05","Ablynx","ABLX","Not yet recruiting","Evaluation of ALX-0171 in Japanese Children Hospitalized for Respiratory Syncytial Virus Lower Respiratory Tract Infection","Alx-0171",null,"Yes","['Alx-0171']","Unknown",null,"Phase 2",5,60,"Anticipated","2018-02-01","2019-05-01",{"$nulls":5},"The objectives of this study are:\n\n * to evaluate the safety, tolerability, and systemic pharmacokinetics (PK) of different doses of inhaled ALX-0171 in Japanese infants and young children hospitalized for respiratory syncytial virus (RSV) lower respiratory tract infection (LRTI).\n * to evaluate the antiviral effect, clinical activity, immunogenicity, and pharmacodynamics (PD) of different doses of inhaled ALX-0171 in Japanese infants and young children hospitalized for RSV LRTI.",null,"A Randomized, Double-blind, Multicenter, Multiple-dose Study of ALX-0171 Versus Placebo Along With Standard of Care in Japanese Infants and Young Children Hospitalized for Respiratory Syncytial Virus Lower Respiratory Tract Infection","ALX0171-C203","Respiratory Syncytial Virus Lower Respiratory Tract Infection","Other","Other","Other","Experimental|Placebo Comparator","ALX-0171 Dose 1|ALX-0171 Dose 2|ALX-0171 Dose 3|ALX-0171 Dose 4|Placebo",null,"Biological|Drug","ALX-0171 Dose 1|ALX-0171 Dose 2|ALX-0171 Dose 3|ALX0171 Dose 4|Placebo","Inhalation of ALX-0171 Dose 1 once daily for 3 consecutive days|Inhalation of ALX-0171 Dose 2 once daily for 3 consecutive days|Inhalation of ALX-0171 Dose 3 once daily for 3 consecutive days|Inhalation of ALX-0171 Dose 4 once daily for 3 consecutive days|Inhalation of Placebo once daily for 3 consecutive days",null,"ALX-0171 Dose 1|ALX-0171 Dose 2|ALX-0171 Dose 3|ALX-0171 Dose 4|Placebo","\n\n * Subject is of Japanese descent, i.e., born in Japan to Japanese parents and has Japanese maternal and paternal grandparents.\n * Subject is otherwise healthy, but is hospitalized for and clinically diagnosed with RSV LRTI\n * Subject has a positive RSV diagnostic test.\n * Symptoms likely related to RSV infection have appeared within 4 days of screening and are not yet improving\n\nOthers as defined in the protocol\n\n","\n\n * Subject is known to have significant comorbidities\n * Subject is known to be immunocompromised\n * Subject has or is suspected to have an active, clinically relevant concurrent infection\n * Subject received invasive mechanical ventilation or non-invasive respiratory support (i.e., continuous or bilevel positive airway pressure) in the 4 weeks prior to screening.\n\nOthers as defined in the protocol",{"$nulls":4},"Actual","2018-02-01","Actual","Anticipated","2019-05-01","Anticipated","2018-01-01","2018-01-26","2018-01-26","2018-02-01","Yes",null,"Interventional","Treatment","Sequential Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized",null,"2 Years","All",null,"No","No",{"$nulls":3},"No","No",{"$nulls":4},"No",{"$nulls":14},"Safety and tolerability as measured by the incidence of treatment-emergent (serious) adverse events","From time of first dose to 28 days after first dose",null,"Pharmacokinetics as measured by the concentration of ALX-0171 in serum|Time for viral load to drop below assay quantification limit (BQL)|Global Severity Score|Time to Clinical Response|Immunogenicity as measured by the concentration of anti-ALX 0171 antibodies in serum","Day 2 - Day 3|Time needed for the viral load to drop below the assay quantification limit (time-to-BQL) in nasal swab specimens.|Evolution over time in Global Severity Score. The Global Severity Score is the sum of the scores of 7 individual items, i.e., feeding, medical interventions, respiratory distress, respiratory rate, apnea, general appearance and body temperature. All items are scored from 0 to 3, except for body temperature that is scored from 0 to 2. The total maximum score is 20 points. Higher score indicates more severe disease.|Evaluation of the clinical response of the subjects as defined in the protocol|From day of first dose to 28 days after first dose","From day of first dose to 14 days after first dose|From day of first dose to 28 days after first dose","clinicaltrials@ablynx.com","Ablynx NV Belgium","+32 9 262 00 00",{"$nulls":7},"Ablynx Clinical Department","2018-02-01","2020-05-25T16:40:00.113","2020-05-26T17:10:42.972","NCT03418571"]
["5ecbf4dffe30261b1a0483f5","NCT03418571","2018-03-16","Ablynx","ABLX","Recruiting","Evaluation of ALX-0171 in Japanese Children Hospitalized for Respiratory Syncytial Virus Lower Respiratory Tract Infection","Alx-0171",null,"Yes","['Alx-0171']","Unknown",null,"Phase 2",5,60,"Anticipated","2018-03-01","2019-05-01",{"$nulls":5},"The objectives of this study are:\n\n * to evaluate the safety, tolerability, and systemic pharmacokinetics (PK) of different doses of inhaled ALX-0171 in Japanese infants and young children hospitalized for respiratory syncytial virus (RSV) lower respiratory tract infection (LRTI).\n * to evaluate the antiviral effect, clinical activity, immunogenicity, and pharmacodynamics (PD) of different doses of inhaled ALX-0171 in Japanese infants and young children hospitalized for RSV LRTI.",null,"A Randomized, Double-blind, Multicenter, Multiple-dose Study of ALX-0171 Versus Placebo Along With Standard of Care in Japanese Infants and Young Children Hospitalized for Respiratory Syncytial Virus Lower Respiratory Tract Infection","ALX0171-C203","Respiratory Syncytial Virus Lower Respiratory Tract Infection","Other","Other","Other","Experimental|Placebo Comparator","ALX-0171 Dose 1|ALX-0171 Dose 2|ALX-0171 Dose 3|ALX-0171 Dose 4|Placebo",null,"Biological|Drug","ALX-0171 Dose 1|ALX-0171 Dose 2|ALX-0171 Dose 3|ALX0171 Dose 4|Placebo","Inhalation of ALX-0171 Dose 1 once daily for 3 consecutive days|Inhalation of ALX-0171 Dose 2 once daily for 3 consecutive days|Inhalation of ALX-0171 Dose 3 once daily for 3 consecutive days|Inhalation of ALX-0171 Dose 4 once daily for 3 consecutive days|Inhalation of Placebo once daily for 3 consecutive days",null,"ALX-0171 Dose 1|ALX-0171 Dose 2|ALX-0171 Dose 3|ALX-0171 Dose 4|Placebo","\n\n * Subject is of Japanese descent, i.e., born in Japan to Japanese parents and has Japanese maternal and paternal grandparents.\n * Subject is otherwise healthy, but is hospitalized for and clinically diagnosed with RSV LRTI\n * Subject has a positive RSV diagnostic test.\n * Symptoms likely related to RSV infection have appeared within 4 days of screening and are not yet improving\n\nOthers as defined in the protocol\n\n","\n\n * Subject is known to have significant comorbidities\n * Subject is known to be immunocompromised\n * Subject has or is suspected to have an active, clinically relevant concurrent infection\n * Subject received invasive mechanical ventilation or non-invasive respiratory support (i.e., continuous or bilevel positive airway pressure) in the 4 weeks prior to screening.\n\nOthers as defined in the protocol",{"$nulls":4},"Actual","2018-02-01","Actual","Anticipated","2019-05-01","Anticipated","2018-03-01","2018-01-26","2018-01-26","2018-03-15","Yes",null,"Interventional","Treatment","Sequential Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized",null,"2 Years","All",null,"No","No",{"$nulls":3},"No","No",{"$nulls":4},"No",{"$nulls":14},"Safety and tolerability as measured by the incidence of treatment-emergent (serious) adverse events","From time of first dose to 28 days after first dose",null,"Pharmacokinetics as measured by the concentration of ALX-0171 in serum|Time for viral load to drop below assay quantification limit (BQL)|Global Severity Score|Time to Clinical Response|Immunogenicity as measured by the concentration of anti-ALX 0171 antibodies in serum","Day 2 - Day 3|Time needed for the viral load to drop below the assay quantification limit (time-to-BQL) in nasal swab specimens.|Evolution over time in Global Severity Score. The Global Severity Score is the sum of the scores of 7 individual items, i.e., feeding, medical interventions, respiratory distress, respiratory rate, apnea, general appearance and body temperature. All items are scored from 0 to 3, except for body temperature that is scored from 0 to 2. The total maximum score is 20 points. Higher score indicates more severe disease.|Evaluation of the clinical response of the subjects as defined in the protocol|From day of first dose to 28 days after first dose","From day of first dose to 14 days after first dose|From day of first dose to 28 days after first dose","clinicaltrials@ablynx.com","Ablynx NV Belgium","+32 9 262 00 00","Gifu, Japan|Nagano-Shi, Japan|Saitama-Shi, Japan|Ueda, Japan|Wako, Japan|Yokosuka, Japan|Fukuyama-Shi, Japan",null,"Belgium|Japan","Clinicaltrials@Ablynx.Com Investigator Site|Clinicaltrials@Ablynx.Com Investigator Site 1|Clinicaltrials@Ablynx.Com Investigator Site 2|Investigator Site",{"$nulls":3},"Ablynx Clinical Department","2018-03-15","2020-05-25T16:39:59.771","2020-05-26T17:10:42.972","NCT03418571"]
["5ecbf4dfe2561b1b11905eef","NCT03418571","2018-05-15","Ablynx","ABLX","Recruiting","Evaluation of ALX-0171 in Japanese Children Hospitalized for Respiratory Syncytial Virus Lower Respiratory Tract Infection","Alx-0171",null,"Yes","['Alx-0171']","Unknown",null,"Phase 2",5,60,"Anticipated","2018-03-01","2019-05-01",{"$nulls":5},"The objectives of this study are:\n\n * to evaluate the safety, tolerability, and systemic pharmacokinetics (PK) of different doses of inhaled ALX-0171 in Japanese infants and young children hospitalized for respiratory syncytial virus (RSV) lower respiratory tract infection (LRTI).\n * to evaluate the antiviral effect, clinical activity, immunogenicity, and pharmacodynamics (PD) of different doses of inhaled ALX-0171 in Japanese infants and young children hospitalized for RSV LRTI.",null,"A Randomized, Double-blind, Multicenter, Multiple-dose Study of ALX-0171 Versus Placebo Along With Standard of Care in Japanese Infants and Young Children Hospitalized for Respiratory Syncytial Virus Lower Respiratory Tract Infection","ALX0171-C203","Respiratory Syncytial Virus Lower Respiratory Tract Infection","Other","Other","Other","Experimental|Placebo Comparator","ALX-0171 Dose 1|ALX-0171 Dose 2|ALX-0171 Dose 3|ALX-0171 Dose 4|Placebo",null,"Biological|Drug","ALX-0171 Dose 1|ALX-0171 Dose 2|ALX-0171 Dose 3|ALX0171 Dose 4|Placebo","Inhalation of ALX-0171 Dose 1 once daily for 3 consecutive days|Inhalation of ALX-0171 Dose 2 once daily for 3 consecutive days|Inhalation of ALX-0171 Dose 3 once daily for 3 consecutive days|Inhalation of ALX-0171 Dose 4 once daily for 3 consecutive days|Inhalation of Placebo once daily for 3 consecutive days",null,"ALX-0171 Dose 1|ALX-0171 Dose 2|ALX-0171 Dose 3|ALX-0171 Dose 4|Placebo","\n\n * Subject is of Japanese descent, i.e., born in Japan to Japanese parents and has Japanese maternal and paternal grandparents.\n * Subject is otherwise healthy, but is hospitalized for and clinically diagnosed with RSV LRTI\n * Subject has a positive RSV diagnostic test.\n * Symptoms likely related to RSV infection have appeared within 4 days of screening and are not yet improving\n\nOthers as defined in the protocol\n\n","\n\n * Subject is known to have significant comorbidities\n * Subject is known to be immunocompromised\n * Subject has or is suspected to have an active, clinically relevant concurrent infection\n * Subject received invasive mechanical ventilation or non-invasive respiratory support (i.e., continuous or bilevel positive airway pressure) in the 4 weeks prior to screening.\n\nOthers as defined in the protocol",{"$nulls":4},"Actual","2018-02-01","Actual","Anticipated","2019-05-01","Anticipated","2018-05-01","2018-01-26","2018-01-26","2018-05-14","Yes",null,"Interventional","Treatment","Sequential Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized",null,"2 Years","All",null,"No","No",{"$nulls":3},"No","No",{"$nulls":4},"No",{"$nulls":14},"Safety and tolerability as measured by the incidence of treatment-emergent (serious) adverse events","From time of first dose to 28 days after first dose",null,"Pharmacokinetics as measured by the concentration of ALX-0171 in serum|Time for viral load to drop below assay quantification limit (BQL)|Global Severity Score|Time to Clinical Response|Immunogenicity as measured by the concentration of anti-ALX 0171 antibodies in serum","Day 2 - Day 3|Time needed for the viral load to drop below the assay quantification limit (time-to-BQL) in nasal swab specimens.|Evolution over time in Global Severity Score. The Global Severity Score is the sum of the scores of 7 individual items, i.e., feeding, medical interventions, respiratory distress, respiratory rate, apnea, general appearance and body temperature. All items are scored from 0 to 3, except for body temperature that is scored from 0 to 2. The total maximum score is 20 points. Higher score indicates more severe disease.|Evaluation of the clinical response of the subjects as defined in the protocol|From day of first dose to 28 days after first dose","From day of first dose to 14 days after first dose|From day of first dose to 28 days after first dose","clinicaltrials@ablynx.com","Ablynx NV Belgium","+32 9 262 00 00","Asahikawa, Japan|Fuchu-Shi, Japan|Fukuyama-Shi, Japan|Funabashi, Japan|Gifu, Japan|Isesaki, Japan|Kawasaki, Japan|Koga, Japan|Kurashiki, Japan|Kurume-Shi, Japan|Meguro-Ku, Japan|Minami-Ku, Japan|Nagano-Shi, Japan|Saitama-Shi, Japan|Shimotsuke-Shi, Japan|Takatsuki, Japan|Toshima-Ku, Japan|Toyohira, Japan|Ueda, Japan|Wako, Japan|Yachiyo, Japan|ÅŒmura, Japan|Yokosuka, Japan|Aoi-Ku, Japan",null,"Belgium|Japan","Clinicaltrials@Ablynx.Com Investigator Site|Clinicaltrials@Ablynx.Com Investigator Site 1|Clinicaltrials@Ablynx.Com Investigator Site 2|Investigator Site",{"$nulls":3},"Ablynx Clinical Department","2018-05-14","2020-05-25T16:39:59.686","2020-05-26T17:10:42.972","NCT03418571"]
["5ecbf4e0feab101b15530a24","NCT03418571","2018-11-16","Ablynx","ABLX","Terminated","Evaluation of ALX-0171 in Japanese Children Hospitalized for Respiratory Syncytial Virus Lower Respiratory Tract Infection","Alx-0171",null,"Yes","['Alx-0171']","Unknown",null,"Phase 2",5,15,"Actual","2018-03-01","2018-10-24",{"$nulls":5},"The objectives of this study are:\n\n * to evaluate the safety, tolerability, and systemic pharmacokinetics (PK) of different doses of inhaled ALX-0171 in Japanese infants and young children hospitalized for respiratory syncytial virus (RSV) lower respiratory tract infection (LRTI).\n * to evaluate the antiviral effect, clinical activity, immunogenicity, and pharmacodynamics (PD) of different doses of inhaled ALX-0171 in Japanese infants and young children hospitalized for RSV LRTI.",null,"A Randomized, Double-blind, Multicenter, Multiple-dose Study of ALX-0171 Versus Placebo Along With Standard of Care in Japanese Infants and Young Children Hospitalized for Respiratory Syncytial Virus Lower Respiratory Tract Infection","ALX0171-C203","Respiratory Syncytial Virus Lower Respiratory Tract Infection","Other","Other","Other","Experimental|Placebo Comparator","ALX-0171 Dose 1|ALX-0171 Dose 2|ALX-0171 Dose 3|ALX-0171 Dose 4|Placebo",null,"Biological|Drug","ALX-0171 Dose 1|ALX-0171 Dose 2|ALX-0171 Dose 3|ALX0171 Dose 4|Placebo","Inhalation of ALX-0171 Dose 1 once daily for 3 consecutive days|Inhalation of ALX-0171 Dose 2 once daily for 3 consecutive days|Inhalation of ALX-0171 Dose 3 once daily for 3 consecutive days|Inhalation of ALX-0171 Dose 4 once daily for 3 consecutive days|Inhalation of Placebo once daily for 3 consecutive days",null,"ALX-0171 Dose 1|ALX-0171 Dose 2|ALX-0171 Dose 3|ALX-0171 Dose 4|Placebo","\n\n * Subject is of Japanese descent, i.e., born in Japan to Japanese parents and has Japanese maternal and paternal grandparents.\n * Subject is otherwise healthy, but is hospitalized for and clinically diagnosed with RSV LRTI\n * Subject has a positive RSV diagnostic test.\n * Symptoms likely related to RSV infection have appeared within 4 days of screening and are not yet improving\n\nOthers as defined in the protocol\n\n","\n\n * Subject is known to have significant comorbidities\n * Subject is known to be immunocompromised\n * Subject has or is suspected to have an active, clinically relevant concurrent infection\n * Subject received invasive mechanical ventilation or non-invasive respiratory support (i.e., continuous or bilevel positive airway pressure) in the 4 weeks prior to screening.\n\nOthers as defined in the protocol",{"$nulls":4},"Actual","2018-02-01","Actual","Actual","2018-10-24","Actual","2018-11-01","2018-01-26","2018-01-26","2018-11-15","Yes",null,"Interventional","Treatment","Sequential Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized",null,"2 Years","All",null,"No","No",{"$nulls":3},"No","No",{"$nulls":4},"No",{"$nulls":14},"Safety and tolerability as measured by the incidence of treatment-emergent (serious) adverse events","From time of first dose to 28 days after first dose",null,"Pharmacokinetics as measured by the concentration of ALX-0171 in serum|Time for viral load to drop below assay quantification limit (BQL)|Global Severity Score|Time to Clinical Response|Immunogenicity as measured by the concentration of anti-ALX 0171 antibodies in serum","Day 2 - Day 3|Time needed for the viral load to drop below the assay quantification limit (time-to-BQL) in nasal swab specimens.|Evolution over time in Global Severity Score. The Global Severity Score is the sum of the scores of 7 individual items, i.e., feeding, medical interventions, respiratory distress, respiratory rate, apnea, general appearance and body temperature. All items are scored from 0 to 3, except for body temperature that is scored from 0 to 2. The total maximum score is 20 points. Higher score indicates more severe disease.|Evaluation of the clinical response of the subjects as defined in the protocol|From day of first dose to 28 days after first dose","From day of first dose to 14 days after first dose|From day of first dose to 28 days after first dose",{"$nulls":3},"Aoi-Ku, Japan Investigator SiteAsahikawa, Japan Investigator SiteFuchu-Shi, Japan Investigator SiteFukuyama-Shi, Japan Investigator SiteFunabashi, Japan Investigator SiteGifu, Japan Investigator SiteIsesaki, Japan Investigator SiteKawasaki, Japan Investigator SiteKoga, Japan Investigator SiteKurashiki, Japan Investigator SiteKurume-Shi, Japan Investigator SiteMeguro-Ku, Japan Investigator SiteMinami-Ku, Japan Investigator SiteNagano-Shi, Japan Investigator SiteSaitama-Shi, Japan Investigator SiteShimotsuke-Shi, Japan Investigator SiteTakatsuki, Japan Investigator SiteToshima-Ku, Japan Investigator SiteToyohira, Japan Investigator SiteUeda, Japan Investigator SiteWako, Japan Investigator SiteYachiyo, Japan Investigator Site 1Yokosuka, Japan Investigator Site 2Yokosuka, Japan Investigator SiteÅŒmura, Japan",null,"Japan","Investigator Site",{"$nulls":3},"Ablynx Clinical Department","2018-11-15","2020-05-25T16:40:00.111","2020-05-26T17:10:42.972","NCT03418571"]
["5ecbf4e0e2561b1b11905ef0","NCT03418571","2019-07-15","Ablynx","ABLX","Terminated","Evaluation of ALX-0171 in Japanese Children Hospitalized for Respiratory Syncytial Virus Lower Respiratory Tract Infection","Alx-0171",null,"Yes","['Alx-0171']","Unknown",null,"Phase 2",2,15,"Actual","2018-03-01","2018-10-24",{"$nulls":5},"This was a randomized, double-blind, multicenter, Phase II study designed to support the selection of an optimal dose of inhaled ALX-0171 for further clinical development, taking ethnicity into consideration.\n\nBased on the results of the Phase IIb dose-ranging study ALX0171-C201 (RESPIRE), the Sponsor decided to discontinue ALX-0171 development in infants and to early terminate the ALX0171-C203 study.","Four dose levels were planned to be evaluated in four consecutive cohorts consisting of Japanese infants and young children aged 28 days to <2 years with a gestational age â‰¥33 weeks who were hospitalized for and diagnosed with respiratory syncytial virus (RSV) lower respiratory tract infection (LRTI):\n\n * Dose level 1: target dose of 1.5 mg/kg\n * Dose level 2: target dose of 3.0 mg/kg\n * Dose level 3: target dose of 6.0 mg/kg\n * Dose level 4: target dose of 9.0 mg/kg\n\nEach cohort was planned to consist of 15 subjects enrolled and randomly assigned to receive ALX-0171 or placebo, in an allocation ratio of 4:1 (N = 12 active versus N = 3 placebo per cohort).\n\nDue to early termination of the trial, only enrollment of Cohort 1 could be completed as planned. For Cohort 2, only 1 subject was screened but did not meet the eligibility criteria and was considered a screen failure. Therefore, data were not available for treatment groups ALX-0171 3.0 mg/kg, 6.0 mg/kg, and 9.0 mg/kg.\n\nOf note, in line with applicable guidelines, an Independent Data Monitoring Committee (IDMC) was assigned to monitor the study. Upon completing of Cohort 1, the IDMC reviewed the available unblinded safety data and unanimously recommended to continue the study with no changes to the protocol.","A Randomized, Double-blind, Multicenter, Multiple-dose Study of ALX-0171 Versus Placebo Along With Standard of Care in Japanese Infants and Young Children Hospitalized for Respiratory Syncytial Virus Lower Respiratory Tract Infection","ALX0171-C203","Respiratory Syncytial Virus Lower Respiratory Tract Infection","Other","Other","Other","Experimental|Placebo Comparator","ALX-0171 1.5 mg/kg|Placebo",null,"Biological|Drug","ALX-0171 1.5 mg/kg|Placebo","ALX-0171 1.5 mg/kg was administered via a single inhalation once daily for 3 consecutive days.|Placebo was administered via a single inhalation once daily for 3 consecutive days.",null,"ALX-0171 1.5 mg/kg|Placebo",{"$nulls":6},"Actual","2018-02-01","Actual","Actual","2018-10-24","Actual","2019-05-01","2018-01-26","2018-01-26","2019-05-02","Yes",null,"Interventional","Treatment","Sequential Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized",null,"2 Years","All",null,"No","No",{"$nulls":3},"No","No","2019-05-02","2019-05-02","2019-07-15","Actual","No",{"$nulls":23},"Aoi-Ku, Japan Investigator SiteAsahikawa, Japan Investigator SiteFuchu-Shi, Japan Investigator SiteFukuyama-Shi, Japan Investigator SiteFunabashi, Japan Investigator SiteGifu, Japan Investigator SiteIsesaki, Japan Investigator SiteKawasaki, Japan Investigator SiteKoga, Japan Investigator SiteKurashiki, Japan Investigator SiteKurume-Shi, Japan Investigator SiteMeguro-Ku, Japan Investigator SiteMinami-Ku, Japan Investigator SiteNagano-Shi, Japan Investigator SiteSaitama-Shi, Japan Investigator SiteShimotsuke-Shi, Japan Investigator SiteTakatsuki, Japan Investigator SiteToshima-Ku, Japan Investigator SiteToyohira, Japan Investigator SiteUeda, Japan Investigator SiteWako, Japan Investigator SiteYachiyo, Japan Investigator Site 1Yokosuka, Japan Investigator Site 2Yokosuka, Japan Investigator SiteÅŒmura, Japan",null,"Japan","Investigator Site",{"$nulls":3},"Medical Monitor","2019-05-02","2020-05-25T16:40:00.181","2020-05-26T17:10:42.972","NCT03418571"]
["5ecbf4df307e3d1b1f8d9e86","NCT03418571","2019-07-30","Ablynx","ABLX","Terminated","Evaluation of ALX-0171 in Japanese Children Hospitalized for Respiratory Syncytial Virus Lower Respiratory Tract Infection","Alx-0171",null,"Yes","['Alx-0171']","Unknown",null,"Phase 2",2,15,"Actual","2018-03-01","2018-10-24",{"$nulls":5},"This was a randomized, double-blind, multicenter, Phase II study (NCT03418571) designed to support the selection of an optimal dose of inhaled ALX-0171 for further clinical development, taking ethnicity into consideration.\n\nBased on the results of the Phase IIb dose-ranging study ALX0171-C201 (RESPIRE), the Sponsor decided to discontinue ALX-0171 development in infants and to early terminate the ALX0171-C203 study.","Four dose levels were planned to be evaluated in four consecutive cohorts consisting of Japanese infants and young children aged 28 days to <2 years with a gestational age â‰¥33 weeks who were hospitalized for and diagnosed with respiratory syncytial virus (RSV) lower respiratory tract infection (LRTI):\n\n * Dose level 1: target dose of 1.5 mg/kg\n * Dose level 2: target dose of 3.0 mg/kg\n * Dose level 3: target dose of 6.0 mg/kg\n * Dose level 4: target dose of 9.0 mg/kg\n\nEach cohort was planned to consist of 15 subjects enrolled and randomly assigned to receive ALX-0171 or placebo, in an allocation ratio of 4:1 (N = 12 active versus N = 3 placebo per cohort).\n\nDue to early termination of the trial, only enrollment of Cohort 1 could be completed as planned. For Cohort 2, only 1 subject was screened but did not meet the eligibility criteria and was considered a screen failure. Therefore, data were not available for treatment groups ALX-0171 3.0 mg/kg, 6.0 mg/kg, and 9.0 mg/kg.\n\nOf note, in line with applicable guidelines, an Independent Data Monitoring Committee (IDMC) was assigned to monitor the study. Upon completing of Cohort 1, the IDMC reviewed the available unblinded safety data and unanimously recommended to continue the study with no changes to the protocol.","A Randomized, Double-blind, Multicenter, Multiple-dose Study of ALX-0171 Versus Placebo Along With Standard of Care in Japanese Infants and Young Children Hospitalized for Respiratory Syncytial Virus Lower Respiratory Tract Infection","ALX0171-C203","Respiratory Syncytial Virus Lower Respiratory Tract Infection","Other","Other","Other","Experimental|Placebo Comparator","ALX-0171 1.5 mg/kg|Placebo",null,"Biological|Drug","ALX-0171 1.5 mg/kg|Placebo","ALX-0171 1.5 mg/kg was administered via a single inhalation once daily for 3 consecutive days.|Placebo was administered via a single inhalation once daily for 3 consecutive days.",null,"ALX-0171 1.5 mg/kg|Placebo",{"$nulls":6},"Actual","2018-02-01","Actual","Actual","2018-10-24","Actual","2019-07-01","2018-01-26","2018-01-26","2019-07-17","Yes",null,"Interventional","Treatment","Sequential Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized",null,"2 Years","All",null,"No","No",{"$nulls":3},"No","No","2019-05-02","2019-05-02","2019-07-15","Actual","No",{"$nulls":23},"Aoi-Ku, Japan Investigator SiteAsahikawa, Japan Investigator SiteFuchu-Shi, Japan Investigator SiteFukuyama-Shi, Japan Investigator SiteFunabashi, Japan Investigator SiteGifu, Japan Investigator SiteIsesaki, Japan Investigator SiteKawasaki, Japan Investigator SiteKoga, Japan Investigator SiteKurashiki, Japan Investigator SiteKurume-Shi, Japan Investigator SiteMeguro-Ku, Japan Investigator SiteMinami-Ku, Japan Investigator SiteNagano-Shi, Japan Investigator SiteSaitama-Shi, Japan Investigator SiteShimotsuke-Shi, Japan Investigator SiteTakatsuki, Japan Investigator SiteToshima-Ku, Japan Investigator SiteToyohira, Japan Investigator SiteUeda, Japan Investigator SiteWako, Japan Investigator SiteYachiyo, Japan Investigator Site 1Yokosuka, Japan Investigator Site 2Yokosuka, Japan Investigator SiteÅŒmura, Japan",null,"Japan","Investigator Site",{"$nulls":3},"Medical Monitor","2019-07-17","2020-05-25T16:39:59.971","2020-05-26T17:10:42.972","NCT03418571"]
["5ecbf4e0feab101b15530a25","NCT03418688","2018-02-01","Cortexyme","CRTX","Not yet recruiting","A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study of COR388","Cor-388",null,"Yes","['Cor-388']","Unknown",null,"Phase 1",2,36,"Anticipated","2018-02-15","2018-06-15","AUC","Area Under The Curve",{"$nulls":3},"The study is a randomized, double-blind, placebo-controlled, multiple ascending dose study to assess the safety and tolerability of ascending repeat doses of COR388 HCl in older healthy male and female subjects and a cohort of Alzheimer's disease subjects.","The study will enroll 3 cohorts of 8 healthy subjects â‰¥55 and â‰¤80 years of age at the Clinical Pharmacology Unit (CPU) and 1 cohort of 12 AD subjects â‰¥55 and â‰¤80 years of age. Subjects in cohorts 1-3 will receive the study drug or placebo for 10 consecutive days while confined to the CPU. AD patients in cohort 4 will receive the study drug or placebo for 28 days as outpatient. Blood samples samples will be collected for pharmacokinetic measurements.","A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study of COR388 in Older Healthy Volunteers and Patients With Alzheimer's Disease","COR388-002","Alzheimer Disease","Alzheimer Disease","Neurocognitive Disorders","Central Nervous System","Active Comparator|Placebo Comparator","COR388|Placebo","Increasing doses of COR388 will be administered for 10 days in cohorts 1-3 and for 28 days in cohort 4.|Matching placebo capsules will be administered for 10 days in cohorts 1-3 and for 28 days in cohort 4.","Drug","COR388|Placebo","COR388 administered for 10 or 28 days.|Placebo administered for 10 or 28 days.","COR388 HCl","COR388|Placebo","\n\n * Male or female subjects â‰¥55 years to â‰¤80 years of age, at the time of consent;\n * Males of reproductive potential must agree to use double-barrier contraceptive measures or avoid intercourse from the first dose of study drug through 90 days after the last dose of study drug.\n * Females of child-bearing potential must be non-lactating, have negative serum pregnancy test results at Screening and negative urine pregnancy test results at Day -1; agree to use double-barrier or hormonal contraceptive measures or avoid intercourse from Day -10 through 28 days after the last dose of study drug.\n * Stable doses of medications used for stable chronic illnesses that are not prohibited by the protocol are allowed as long as the dose has been stable for 30 days prior to Screening, and no changes are expected during participation in the study;\n * Body mass index â‰¥19 kg/m2 to â‰¤35 kg/m2 at Screening;\n * Good general health as determined by medical history, physical examination, laboratory reports, and 12-lead ECG prior to enrollment;\n * Non-smoker and non-tobacco user for a minimum of 6 months prior to the first admission and for the duration of the study;\n * Able to swallow capsules;\n * Fluent in, and able to read and comprehend, the English language;\n\nCohort 4 Only:\n\n * Must have probable AD according to the NINDS-ADRD criteria; and an MMSE-2 score â‰¥14 and â‰¤25;\n * Must have moderate to severe periodontitis according to the CDC-AAP criteria as determined by the study dentist during the screening oral examination;\n * If applicable, have a primary caregiver willing to accept responsibility for supervising the treatment (eg, administering study drug) and assessing the condition of the subject throughout the study in accordance with all protocol requirements.\n * Provide, if mentally competent and willing, written informed consent. If the subject is not able to provide written informed consent, written informed consent must be obtained from a legally authorized representative on the subject's behalf, and verbal assent may be obtained from the subject. In addition, if the subject has a caregiver, the caregiver will be required to provide written informed consent prior to the subject's participation in the study.\n\n","\n\n * History or current evidence of clinically significant arrhythmia, heart failure, or hypotension in the Investigator's judgment;\n * History or current evidence of clinically significant liver disease in the Investigator's judgment;\n * Evidence of renal insufficiency defined as an estimated glomerular filtration rate <50 mL/min/1.73m2 at Screening;\n * Subjects who received any treatment for periodontitis in the last 90 days including systemic or local antibiotics (eg, PerioChipÂ®), scaling, root planing, or other surgical treatments;\n * Uncontrolled medical or psychiatric illness, uncontrolled seizure disorder, or history of major stroke;\n * Active, or recent history of, systemic infection within 30 days prior to Screening that required treatment with antibiotics for longer than 1 week;\n * History or current evidence of psychiatric or emotional problems that would invalidate giving informed consent or limit the ability of the subject to comply with study requirements;\n * History of systemic allergic reaction to any drug that is considered significant by the Investigator;\n * History of alcohol or drug abuse or dependence within 12 months of Screening, as determined by the Investigator;\n * Positive alcohol screen at Screening or on Day -1;\n * Positive urine screen for prohibited drugs\n * Positive blood screen for human immunodeficiency virus (1 and 2), hepatitis B surface antigen, or hepatitis C virus antibodies at Screening;\n * Any conditions that, in the opinion of the Investigator, would make the subject unsuitable for enrollment, could interfere with the subject's participation in or completion of the study, or could interfere with interpretation of study results;\n * Abnormal results of screening laboratory tests, ECG, or MRI of the brain deemed clinically significant by the Investigator;\n * The use of any prohibited medication that cannot be stopped or replaced safely, based on the judgment of the Investigator; or\n * Participation in another investigational new drug research study involving small molecule drugs within 30 days or biological drugs within 60 days prior to the first dose of study drug.",{"$nulls":4},"Actual","2018-02-01","Actual","Anticipated","2018-07-01","Anticipated","2018-01-01","2018-01-26","2018-01-26","2018-01-26","Yes",null,"Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","55 Years","80 Years","All",null,"Yes","No",{"$nulls":3},"Yes","No",{"$nulls":19},"AUC|Cmax|Tmax","Area under the concentration-time curve|Maximum observed drug concentration during a dosing interval|Time to Cmax","Day 1 and Day 10",{"$nulls":3},"skaba@cortexyme.com","Samer Kaba, MD","1-404-819-3726",{"$nulls":8},"2018-01-26","2020-05-25T16:40:00.217","2020-05-26T17:10:42.972","NCT03418688"]
["5ecbf4e0307e3d1b1f8d9e87","NCT03418688","2018-02-06","Cortexyme","CRTX","Not yet recruiting","A Multiple Ascending Dose Study of COR388","Cor-388",null,"Yes","['Cor-388']","Unknown",null,"Phase 1",2,36,"Anticipated","2018-02-15","2018-06-15","AUC","Area Under The Curve",{"$nulls":3},"The study is a randomized, double-blind, placebo-controlled, multiple ascending dose study to assess the safety and tolerability of ascending repeat doses of COR388 HCl in older healthy male and female subjects and a cohort of Alzheimer's disease subjects.","The study will enroll 3 cohorts of 8 healthy subjects â‰¥55 and â‰¤80 years of age at the Clinical Pharmacology Unit (CPU) and 1 cohort of 12 AD subjects â‰¥55 and â‰¤80 years of age. Subjects in cohorts 1-3 will receive the study drug or placebo for 10 consecutive days while confined to the CPU. AD patients in cohort 4 will receive the study drug or placebo for 28 days as outpatient. Blood samples samples will be collected for pharmacokinetic measurements.","A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study of COR388 in Older Healthy Volunteers and Patients With Alzheimer's Disease","COR388-002","Alzheimer Disease","Alzheimer Disease","Neurocognitive Disorders","Central Nervous System","Active Comparator|Placebo Comparator","COR388|Placebo","Increasing doses of COR388 will be administered for 10 days in cohorts 1-3 and for 28 days in cohort 4.|Matching placebo capsules will be administered for 10 days in cohorts 1-3 and for 28 days in cohort 4.","Drug","COR388|Placebo","COR388 administered for 10 or 28 days.|Placebo administered for 10 or 28 days.","COR388 HCl","COR388|Placebo","\n\n * Male or female subjects â‰¥55 years to â‰¤80 years of age, at the time of consent;\n * Males of reproductive potential must agree to use double-barrier contraceptive measures or avoid intercourse from the first dose of study drug through 90 days after the last dose of study drug.\n * Females of child-bearing potential must be non-lactating, have negative serum pregnancy test results at Screening and negative urine pregnancy test results at Day -1; agree to use double-barrier or hormonal contraceptive measures or avoid intercourse from Day -10 through 28 days after the last dose of study drug.\n * Stable doses of medications used for stable chronic illnesses that are not prohibited by the protocol are allowed as long as the dose has been stable for 30 days prior to Screening, and no changes are expected during participation in the study;\n * Body mass index â‰¥19 kg/m2 to â‰¤35 kg/m2 at Screening;\n * Good general health as determined by medical history, physical examination, laboratory reports, and 12-lead ECG prior to enrollment;\n * Non-smoker and non-tobacco user for a minimum of 6 months prior to the first admission and for the duration of the study;\n * Able to swallow capsules;\n * Fluent in, and able to read and comprehend, the English language;\n\nCohort 4 Only:\n\n * Must have probable AD according to the NINDS-ADRD criteria; and an MMSE-2 score â‰¥14 and â‰¤25;\n * Must have moderate to severe periodontitis according to the CDC-AAP criteria as determined by the study dentist during the screening oral examination;\n * If applicable, have a primary caregiver willing to accept responsibility for supervising the treatment (eg, administering study drug) and assessing the condition of the subject throughout the study in accordance with all protocol requirements.\n * Provide, if mentally competent and willing, written informed consent. If the subject is not able to provide written informed consent, written informed consent must be obtained from a legally authorized representative on the subject's behalf, and verbal assent may be obtained from the subject. In addition, if the subject has a caregiver, the caregiver will be required to provide written informed consent prior to the subject's participation in the study.\n\n","\n\n * History or current evidence of clinically significant arrhythmia, heart failure, or hypotension in the Investigator's judgment;\n * History or current evidence of clinically significant liver disease in the Investigator's judgment;\n * Evidence of renal insufficiency defined as an estimated glomerular filtration rate <50 mL/min/1.73m2 at Screening;\n * Subjects who received any treatment for periodontitis in the last 90 days including systemic or local antibiotics (eg, PerioChipÂ®), scaling, root planing, or other surgical treatments;\n * Uncontrolled medical or psychiatric illness, uncontrolled seizure disorder, or history of major stroke;\n * Active, or recent history of, systemic infection within 30 days prior to Screening that required treatment with antibiotics for longer than 1 week;\n * History or current evidence of psychiatric or emotional problems that would invalidate giving informed consent or limit the ability of the subject to comply with study requirements;\n * History of systemic allergic reaction to any drug that is considered significant by the Investigator;\n * History of alcohol or drug abuse or dependence within 12 months of Screening, as determined by the Investigator;\n * Positive alcohol screen at Screening or on Day -1;\n * Positive urine screen for prohibited drugs\n * Positive blood screen for human immunodeficiency virus (1 and 2), hepatitis B surface antigen, or hepatitis C virus antibodies at Screening;\n * Any conditions that, in the opinion of the Investigator, would make the subject unsuitable for enrollment, could interfere with the subject's participation in or completion of the study, or could interfere with interpretation of study results;\n * Abnormal results of screening laboratory tests, ECG, or MRI of the brain deemed clinically significant by the Investigator;\n * The use of any prohibited medication that cannot be stopped or replaced safely, based on the judgment of the Investigator; or\n * Participation in another investigational new drug research study involving small molecule drugs within 30 days or biological drugs within 60 days prior to the first dose of study drug.",{"$nulls":4},"Actual","2018-02-01","Actual","Anticipated","2018-07-01","Anticipated","2018-02-01","2018-01-26","2018-01-26","2018-02-04","Yes",null,"Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","55 Years","80 Years","All",null,"Yes","No",{"$nulls":3},"Yes","No",{"$nulls":19},"AUC|Cmax|Tmax","Area under the concentration-time curve|Maximum observed drug concentration during a dosing interval|Time to Cmax","Day 1 and Day 10",{"$nulls":3},"skaba@cortexyme.com","Samer Kaba, MD","1-404-819-3726",{"$nulls":8},"2018-02-04","2020-05-25T16:40:00.129","2020-05-26T17:10:42.972","NCT03418688"]
["5ecbf4e0fe30261b1a0483f6","NCT03418688","2018-02-14","Cortexyme","CRTX","Not yet recruiting","A Multiple Ascending Dose Study of COR388","Cor-388",null,"Yes","['Cor-388']","Unknown",null,"Phase 1",2,36,"Anticipated","2018-02-15","2018-06-15","AUC","Area Under The Curve",{"$nulls":3},"The study is a randomized, double-blind, placebo-controlled, multiple ascending dose study to assess the safety and tolerability of ascending repeat doses of COR388 HCl in older healthy male and female subjects and a cohort of Alzheimer's disease subjects.","The study will enroll 3 cohorts of 8 healthy subjects â‰¥55 and â‰¤80 years of age at the Clinical Pharmacology Unit (CPU) and 1 cohort of 12 AD subjects â‰¥55 and â‰¤80 years of age. Subjects in cohorts 1-3 will receive the study drug or placebo for 10 consecutive days while confined to the CPU. AD patients in cohort 4 will receive the study drug or placebo for 28 days as outpatient. Blood samples samples will be collected for pharmacokinetic measurements.","A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study of COR388 in Older Healthy Volunteers and Patients With Alzheimer's Disease","COR388-002","Alzheimer Disease","Alzheimer Disease","Neurocognitive Disorders","Central Nervous System","Active Comparator|Placebo Comparator","COR388|Placebo","Increasing doses of COR388 will be administered for 10 days in cohorts 1-3 and for 28 days in cohort 4.|Matching placebo capsules will be administered for 10 days in cohorts 1-3 and for 28 days in cohort 4.","Drug","COR388|Placebo","COR388 administered for 10 or 28 days.|Placebo administered for 10 or 28 days.","COR388 HCl","COR388|Placebo","\n\n * Male or female subjects â‰¥55 years to â‰¤80 years of age, at the time of consent;\n * Males of reproductive potential must agree to use double-barrier contraceptive measures or avoid intercourse from the first dose of study drug through 90 days after the last dose of study drug.\n * Females of child-bearing potential must be non-lactating, have negative serum pregnancy test results at Screening and negative urine pregnancy test results at Day -1; agree to use double-barrier or hormonal contraceptive measures or avoid intercourse from Day -10 through 28 days after the last dose of study drug.\n * Stable doses of medications used for stable chronic illnesses that are not prohibited by the protocol are allowed as long as the dose has been stable for 30 days prior to Screening, and no changes are expected during participation in the study;\n * Body mass index â‰¥19 kg/m2 to â‰¤35 kg/m2 at Screening;\n * Good general health as determined by medical history, physical examination, laboratory reports, and 12-lead ECG prior to enrollment;\n * Non-smoker and non-tobacco user for a minimum of 6 months prior to the first admission and for the duration of the study;\n * Able to swallow capsules;\n * Fluent in, and able to read and comprehend, the English language;\n\nCohort 4 Only:\n\n * Must have probable AD according to the NINDS-ADRD criteria; and an MMSE-2 score â‰¥14 and â‰¤25;\n * Must have moderate to severe periodontitis according to the CDC-AAP criteria as determined by the study dentist during the screening oral examination;\n * If applicable, have a primary caregiver willing to accept responsibility for supervising the treatment (eg, administering study drug) and assessing the condition of the subject throughout the study in accordance with all protocol requirements.\n * Provide, if mentally competent and willing, written informed consent. If the subject is not able to provide written informed consent, written informed consent must be obtained from a legally authorized representative on the subject's behalf, and verbal assent may be obtained from the subject. In addition, if the subject has a caregiver, the caregiver will be required to provide written informed consent prior to the subject's participation in the study.\n\n","\n\n * History or current evidence of clinically significant arrhythmia, heart failure, or hypotension in the Investigator's judgment;\n * History or current evidence of clinically significant liver disease in the Investigator's judgment;\n * Evidence of renal insufficiency defined as an estimated glomerular filtration rate <50 mL/min/1.73m2 at Screening;\n * Subjects who received any treatment for periodontitis in the last 90 days including systemic or local antibiotics (eg, PerioChipÂ®), scaling, root planing, or other surgical treatments;\n * Uncontrolled medical or psychiatric illness, uncontrolled seizure disorder, or history of major stroke;\n * Active, or recent history of, systemic infection within 30 days prior to Screening that required treatment with antibiotics for longer than 1 week;\n * History or current evidence of psychiatric or emotional problems that would invalidate giving informed consent or limit the ability of the subject to comply with study requirements;\n * History of systemic allergic reaction to any drug that is considered significant by the Investigator;\n * History of alcohol or drug abuse or dependence within 12 months of Screening, as determined by the Investigator;\n * Positive alcohol screen at Screening or on Day -1;\n * Positive urine screen for prohibited drugs\n * Positive blood screen for human immunodeficiency virus (1 and 2), hepatitis B surface antigen, or hepatitis C virus antibodies at Screening;\n * Any conditions that, in the opinion of the Investigator, would make the subject unsuitable for enrollment, could interfere with the subject's participation in or completion of the study, or could interfere with interpretation of study results;\n * Abnormal results of screening laboratory tests, ECG, or MRI of the brain deemed clinically significant by the Investigator;\n * The use of any prohibited medication that cannot be stopped or replaced safely, based on the judgment of the Investigator; or\n * Participation in another investigational new drug research study involving small molecule drugs within 30 days or biological drugs within 60 days prior to the first dose of study drug.",{"$nulls":4},"Actual","2018-02-01","Actual","Anticipated","2018-07-01","Anticipated","2018-02-01","2018-01-26","2018-01-26","2018-02-13","Yes",null,"Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","55 Years","80 Years","All",null,"Yes","No",{"$nulls":3},"Yes","No",{"$nulls":19},"AUC|Cmax|Tmax","Area under the concentration-time curve|Maximum observed drug concentration during a dosing interval|Time to Cmax","Day 1 and Day 10",{"$nulls":3},"clinicaltrials@cortexyme.com","Samer Kaba, MD",4048193726,"Orlando, Florida, United States, 32806|Cincinnati, Ohio, United States, 45227","Florida|Ohio","United States","Bioclinica Research|Medpace Clinical Pharmacology Unit",{"$nulls":4},"2018-02-13","2020-05-25T16:40:00.220","2020-05-26T17:10:42.972","NCT03418688"]
["5ecbf4e0307e3d1b1f8d9e88","NCT03418688","2018-03-07","Cortexyme","CRTX","Recruiting","A Multiple Ascending Dose Study of COR388","Cor-388",null,"Yes","['Cor-388']","Unknown",null,"Phase 1",2,36,"Anticipated","2018-03-06","2018-06-15","AUC","Area Under The Curve",{"$nulls":3},"The study is a randomized, double-blind, placebo-controlled, multiple ascending dose study to assess the safety and tolerability of ascending repeat doses of COR388 HCl in older healthy male and female subjects and a cohort of Alzheimer's disease subjects.","The study will enroll 3 cohorts of 8 healthy subjects â‰¥55 and â‰¤80 years of age at the Clinical Pharmacology Unit (CPU) and 1 cohort of 12 AD subjects â‰¥55 and â‰¤80 years of age. Subjects in cohorts 1-3 will receive the study drug or placebo for 10 consecutive days while confined to the CPU. AD patients in cohort 4 will receive the study drug or placebo for 28 days as outpatient. Blood samples samples will be collected for pharmacokinetic measurements.","A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study of COR388 in Older Healthy Volunteers and Patients With Alzheimer's Disease","COR388-002","Alzheimer Disease","Alzheimer Disease","Neurocognitive Disorders","Central Nervous System","Active Comparator|Placebo Comparator","COR388|Placebo","Increasing doses of COR388 will be administered for 10 days in cohorts 1-3 and for 28 days in cohort 4.|Matching placebo capsules will be administered for 10 days in cohorts 1-3 and for 28 days in cohort 4.","Drug","COR388|Placebo","COR388 administered for 10 or 28 days.|Placebo administered for 10 or 28 days.","COR388 HCl","COR388|Placebo","\n\n * Male or female subjects â‰¥55 years to â‰¤80 years of age, at the time of consent;\n * Males of reproductive potential must agree to use double-barrier contraceptive measures or avoid intercourse from the first dose of study drug through 90 days after the last dose of study drug.\n * Females of child-bearing potential must be non-lactating, have negative serum pregnancy test results at Screening and negative urine pregnancy test results at Day -1; agree to use double-barrier or hormonal contraceptive measures or avoid intercourse from Day -10 through 28 days after the last dose of study drug.\n * Stable doses of medications used for stable chronic illnesses that are not prohibited by the protocol are allowed as long as the dose has been stable for 30 days prior to Screening, and no changes are expected during participation in the study;\n * Body mass index â‰¥19 kg/m2 to â‰¤35 kg/m2 at Screening;\n * Good general health as determined by medical history, physical examination, laboratory reports, and 12-lead ECG prior to enrollment;\n * Non-smoker and non-tobacco user for a minimum of 6 months prior to the first admission and for the duration of the study;\n * Able to swallow capsules;\n * Fluent in, and able to read and comprehend, the English language;\n\nCohort 4 Only:\n\n * Must have probable AD according to the NINDS-ADRD criteria; and an MMSE-2 score â‰¥14 and â‰¤25;\n * Must have moderate to severe periodontitis according to the CDC-AAP criteria as determined by the study dentist during the screening oral examination;\n * If applicable, have a primary caregiver willing to accept responsibility for supervising the treatment (eg, administering study drug) and assessing the condition of the subject throughout the study in accordance with all protocol requirements.\n * Provide, if mentally competent and willing, written informed consent. If the subject is not able to provide written informed consent, written informed consent must be obtained from a legally authorized representative on the subject's behalf, and verbal assent may be obtained from the subject. In addition, if the subject has a caregiver, the caregiver will be required to provide written informed consent prior to the subject's participation in the study.\n\n","\n\n * History or current evidence of clinically significant arrhythmia, heart failure, or hypotension in the Investigator's judgment;\n * History or current evidence of clinically significant liver disease in the Investigator's judgment;\n * Evidence of renal insufficiency defined as an estimated glomerular filtration rate <50 mL/min/1.73m2 at Screening;\n * Subjects who received any treatment for periodontitis in the last 90 days including systemic or local antibiotics (eg, PerioChipÂ®), scaling, root planing, or other surgical treatments;\n * Uncontrolled medical or psychiatric illness, uncontrolled seizure disorder, or history of major stroke;\n * Active, or recent history of, systemic infection within 30 days prior to Screening that required treatment with antibiotics for longer than 1 week;\n * History or current evidence of psychiatric or emotional problems that would invalidate giving informed consent or limit the ability of the subject to comply with study requirements;\n * History of systemic allergic reaction to any drug that is considered significant by the Investigator;\n * History of alcohol or drug abuse or dependence within 12 months of Screening, as determined by the Investigator;\n * Positive alcohol screen at Screening or on Day -1;\n * Positive urine screen for prohibited drugs\n * Positive blood screen for human immunodeficiency virus (1 and 2), hepatitis B surface antigen, or hepatitis C virus antibodies at Screening;\n * Any conditions that, in the opinion of the Investigator, would make the subject unsuitable for enrollment, could interfere with the subject's participation in or completion of the study, or could interfere with interpretation of study results;\n * Abnormal results of screening laboratory tests, ECG, or MRI of the brain deemed clinically significant by the Investigator;\n * The use of any prohibited medication that cannot be stopped or replaced safely, based on the judgment of the Investigator; or\n * Participation in another investigational new drug research study involving small molecule drugs within 30 days or biological drugs within 60 days prior to the first dose of study drug.",{"$nulls":4},"Actual","2018-02-01","Actual","Anticipated","2018-07-01","Anticipated","2018-03-01","2018-01-26","2018-01-26","2018-03-06","Yes",null,"Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","55 Years","80 Years","All",null,"Yes","No",{"$nulls":3},"Yes","No",{"$nulls":19},"AUC|Cmax|Tmax","Area under the concentration-time curve|Maximum observed drug concentration during a dosing interval|Time to Cmax","Day 1 and Day 10",{"$nulls":3},"clinicaltrials@cortexyme.com","Samer Kaba, MD",4048193726,"Orlando, Florida, United States, 32806|Cincinnati, Ohio, United States, 45227","Florida|Ohio","United States","Bioclinica Research|Medpace Clinical Pharmacology Unit",{"$nulls":4},"2018-03-06","2020-05-25T16:40:00.656","2020-05-26T17:10:42.972","NCT03418688"]
["5ecbf4e011702c1b1b916c02","NCT03418688","2018-04-18","Cortexyme","CRTX","Recruiting","A Multiple Ascending Dose Study of COR388","Cor-388",null,"Yes","['Cor-388']","Unknown",null,"Phase 1",2,36,"Anticipated","2018-03-06","2018-06-15","AUC","Area Under The Curve",{"$nulls":3},"The study is a randomized, double-blind, placebo-controlled, multiple ascending dose study to assess the safety and tolerability of ascending repeat doses of COR388 HCl in older healthy male and female subjects and a cohort of Alzheimer's disease subjects.","The study will enroll 3 cohorts of 8 healthy subjects â‰¥55 and â‰¤80 years of age at the Clinical Pharmacology Unit (CPU) and 1 cohort of 12 AD subjects â‰¥55 and â‰¤80 years of age. Subjects in cohorts 1-3 will receive the study drug or placebo for 10 consecutive days while confined to the CPU. AD patients in cohort 4 will receive the study drug or placebo for 28 days as outpatient. Blood samples samples will be collected for pharmacokinetic measurements.","A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study of COR388 in Older Healthy Volunteers and Patients With Alzheimer's Disease","COR388-002","Alzheimer Disease","Alzheimer Disease","Neurocognitive Disorders","Central Nervous System","Active Comparator|Placebo Comparator","COR388|Placebo","Increasing doses of COR388 will be administered for 10 days in cohorts 1-3 and for 28 days in cohort 4.|Matching placebo capsules will be administered for 10 days in cohorts 1-3 and for 28 days in cohort 4.","Drug","COR388|Placebo","COR388 administered for 10 or 28 days.|Placebo administered for 10 or 28 days.","COR388 HCl","COR388|Placebo","\n\n * Male or female subjects â‰¥55 years to â‰¤80 years of age, at the time of consent;\n * Males of reproductive potential must agree to use double-barrier contraceptive measures or avoid intercourse from the first dose of study drug through 90 days after the last dose of study drug.\n * Females of child-bearing potential must be non-lactating, have negative serum pregnancy test results at Screening and negative urine pregnancy test results at Day -1; agree to use double-barrier or hormonal contraceptive measures or avoid intercourse from Day -10 through 28 days after the last dose of study drug.\n * Stable doses of medications used for stable chronic illnesses that are not prohibited by the protocol are allowed as long as the dose has been stable for 30 days prior to Screening, and no changes are expected during participation in the study;\n * Body mass index â‰¥19 kg/m2 to â‰¤35 kg/m2 at Screening;\n * Good general health as determined by medical history, physical examination, laboratory reports, and 12-lead ECG prior to enrollment;\n * Non-smoker and non-tobacco user for a minimum of 6 months prior to the first admission and for the duration of the study;\n * Able to swallow capsules;\n * Fluent in, and able to read and comprehend, the English language;\n\nCohort 4 Only:\n\n * Must have probable AD according to the NINDS-ADRD criteria; and an MMSE-2 score â‰¥14 and â‰¤25;\n * Must have moderate to severe periodontitis according to the CDC-AAP criteria as determined by the study dentist during the screening oral examination;\n * If applicable, have a primary caregiver willing to accept responsibility for supervising the treatment (eg, administering study drug) and assessing the condition of the subject throughout the study in accordance with all protocol requirements.\n * Provide, if mentally competent and willing, written informed consent. If the subject is not able to provide written informed consent, written informed consent must be obtained from a legally authorized representative on the subject's behalf, and verbal assent may be obtained from the subject. In addition, if the subject has a caregiver, the caregiver will be required to provide written informed consent prior to the subject's participation in the study.\n\n","\n\n * History or current evidence of clinically significant arrhythmia, heart failure, or hypotension in the Investigator's judgment;\n * History or current evidence of clinically significant liver disease in the Investigator's judgment;\n * Evidence of renal insufficiency defined as an estimated glomerular filtration rate <50 mL/min/1.73m2 at Screening;\n * Subjects who received any treatment for periodontitis in the last 90 days including systemic or local antibiotics (eg, PerioChipÂ®), scaling, root planing, or other surgical treatments;\n * Uncontrolled medical or psychiatric illness, uncontrolled seizure disorder, or history of major stroke;\n * Active, or recent history of, systemic infection within 30 days prior to Screening that required treatment with antibiotics for longer than 1 week;\n * History or current evidence of psychiatric or emotional problems that would invalidate giving informed consent or limit the ability of the subject to comply with study requirements;\n * History of systemic allergic reaction to any drug that is considered significant by the Investigator;\n * History of alcohol or drug abuse or dependence within 12 months of Screening, as determined by the Investigator;\n * Positive alcohol screen at Screening or on Day -1;\n * Positive urine screen for prohibited drugs\n * Positive blood screen for human immunodeficiency virus (1 and 2), hepatitis B surface antigen, or hepatitis C virus antibodies at Screening;\n * Any conditions that, in the opinion of the Investigator, would make the subject unsuitable for enrollment, could interfere with the subject's participation in or completion of the study, or could interfere with interpretation of study results;\n * Abnormal results of screening laboratory tests, ECG, or MRI of the brain deemed clinically significant by the Investigator;\n * The use of any prohibited medication that cannot be stopped or replaced safely, based on the judgment of the Investigator; or\n * Participation in another investigational new drug research study involving small molecule drugs within 30 days or biological drugs within 60 days prior to the first dose of study drug.",{"$nulls":4},"Actual","2018-02-01","Actual","Anticipated","2018-07-01","Anticipated","2018-04-01","2018-01-26","2018-01-26","2018-04-17","Yes",null,"Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","55 Years","80 Years","All",null,"Yes","No",{"$nulls":3},"Yes","No",{"$nulls":19},"AUC|Cmax|Tmax","Area under the concentration-time curve|Maximum observed drug concentration during a dosing interval|Time to Cmax","Day 1 and Day 10",{"$nulls":3},"clinicaltrials@cortexyme.com","Samer Kaba, MD",4048193726,"San Diego, California, United States, 92103|Orlando, Florida, United States, 32806|[Active, Not Recruiting]Cincinnati, Ohio, United States, 45227","California|Florida|Ohio","United States","Pacific Research Network|Bioclinica Research|Medpace Clinical Pharmacology Unit",{"$nulls":4},"2018-04-17","2020-05-25T16:40:00.262","2020-05-26T17:10:42.972","NCT03418688"]
["5ecbf4e0e2561b1b11905ef1","NCT03418688","2018-07-17","Cortexyme","CRTX","Recruiting","A Multiple Ascending Dose Study of COR388","Cor-388",null,"Yes","['Cor-388']","Unknown",null,"Phase 1",2,36,"Anticipated","2018-03-06","2018-09-15","AUC","Area Under The Curve",{"$nulls":3},"The study is a randomized, double-blind, placebo-controlled, multiple ascending dose study to assess the safety and tolerability of ascending repeat doses of COR388 HCl in older healthy male and female subjects and a cohort of Alzheimer's disease subjects.","The study will enroll 3 cohorts of 8 healthy subjects â‰¥55 and â‰¤80 years of age at the Clinical Pharmacology Unit (CPU) and 1 cohort of 12 AD subjects â‰¥55 and â‰¤80 years of age. Subjects in cohorts 1-3 will receive the study drug or placebo for 10 consecutive days while confined to the CPU. AD patients in cohort 4 will receive the study drug or placebo for 28 days as outpatient. Blood samples samples will be collected for pharmacokinetic measurements.","A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study of COR388 in Older Healthy Volunteers and Patients With Alzheimer's Disease","COR388-002","Alzheimer Disease","Alzheimer Disease","Neurocognitive Disorders","Central Nervous System","Active Comparator|Placebo Comparator","COR388|Placebo","Increasing doses of COR388 will be administered for 10 days in cohorts 1-3 and for 28 days in cohort 4.|Matching placebo capsules will be administered for 10 days in cohorts 1-3 and for 28 days in cohort 4.","Drug","COR388|Placebo","COR388 administered for 10 or 28 days.|Placebo administered for 10 or 28 days.","COR388 HCl","COR388|Placebo","\n\n * Male or female subjects â‰¥55 years to â‰¤80 years of age, at the time of consent;\n * Males of reproductive potential must agree to use double-barrier contraceptive measures or avoid intercourse from the first dose of study drug through 90 days after the last dose of study drug.\n * Females of child-bearing potential must be non-lactating, have negative serum pregnancy test results at Screening and negative urine pregnancy test results at Day -1; agree to use double-barrier or hormonal contraceptive measures or avoid intercourse from Day -10 through 28 days after the last dose of study drug.\n * Stable doses of medications used for stable chronic illnesses that are not prohibited by the protocol are allowed as long as the dose has been stable for 30 days prior to Screening, and no changes are expected during participation in the study;\n * Body mass index â‰¥19 kg/m2 to â‰¤35 kg/m2 at Screening;\n * Good general health as determined by medical history, physical examination, laboratory reports, and 12-lead ECG prior to enrollment;\n * Non-smoker and non-tobacco user for a minimum of 6 months prior to the first admission and for the duration of the study;\n * Able to swallow capsules;\n * Fluent in, and able to read and comprehend, the English language;\n\nCohort 4 Only:\n\n * Must have probable AD according to the NINDS-ADRD criteria; and an MMSE-2 score â‰¥14 and â‰¤25;\n * Must have moderate to severe periodontitis according to the CDC-AAP criteria as determined by the study dentist during the screening oral examination;\n * If applicable, have a primary caregiver willing to accept responsibility for supervising the treatment (eg, administering study drug) and assessing the condition of the subject throughout the study in accordance with all protocol requirements.\n * Provide, if mentally competent and willing, written informed consent. If the subject is not able to provide written informed consent, written informed consent must be obtained from a legally authorized representative on the subject's behalf, and verbal assent may be obtained from the subject. In addition, if the subject has a caregiver, the caregiver will be required to provide written informed consent prior to the subject's participation in the study.\n\n","\n\n * History or current evidence of clinically significant arrhythmia, heart failure, or hypotension in the Investigator's judgment;\n * History or current evidence of clinically significant liver disease in the Investigator's judgment;\n * Evidence of renal insufficiency defined as an estimated glomerular filtration rate <50 mL/min/1.73m2 at Screening;\n * Subjects who received any treatment for periodontitis in the last 90 days including systemic or local antibiotics (eg, PerioChipÂ®), scaling, root planing, or other surgical treatments;\n * Uncontrolled medical or psychiatric illness, uncontrolled seizure disorder, or history of major stroke;\n * Active, or recent history of, systemic infection within 30 days prior to Screening that required treatment with antibiotics for longer than 1 week;\n * History or current evidence of psychiatric or emotional problems that would invalidate giving informed consent or limit the ability of the subject to comply with study requirements;\n * History of systemic allergic reaction to any drug that is considered significant by the Investigator;\n * History of alcohol or drug abuse or dependence within 12 months of Screening, as determined by the Investigator;\n * Positive alcohol screen at Screening or on Day -1;\n * Positive urine screen for prohibited drugs\n * Positive blood screen for human immunodeficiency virus (1 and 2), hepatitis B surface antigen, or hepatitis C virus antibodies at Screening;\n * Any conditions that, in the opinion of the Investigator, would make the subject unsuitable for enrollment, could interfere with the subject's participation in or completion of the study, or could interfere with interpretation of study results;\n * Abnormal results of screening laboratory tests, ECG, or MRI of the brain deemed clinically significant by the Investigator;\n * The use of any prohibited medication that cannot be stopped or replaced safely, based on the judgment of the Investigator; or\n * Participation in another investigational new drug research study involving small molecule drugs within 30 days or biological drugs within 60 days prior to the first dose of study drug.",{"$nulls":4},"Actual","2018-02-01","Actual","Anticipated","2018-10-15","Anticipated","2018-07-01","2018-01-26","2018-01-26","2018-07-16","Yes",null,"Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","55 Years","80 Years","All",null,"Yes","No",{"$nulls":3},"Yes","No",{"$nulls":19},"AUC|Cmax|Tmax","Area under the concentration-time curve|Maximum observed drug concentration during a dosing interval|Time to Cmax","Day 1 and Day 10",{"$nulls":3},"clinicaltrials@cortexyme.com","Samer Kaba, MD",4048193726,"San Diego, California, United States, 92103|Orlando, Florida, United States, 32806|[Active, Not Recruiting]Cincinnati, Ohio, United States, 45227","California|Florida|Ohio","United States","Pacific Research Network|Bioclinica Research|Medpace Clinical Pharmacology Unit",{"$nulls":4},"2018-07-16","2020-05-25T16:40:00.555","2020-05-26T17:10:42.972","NCT03418688"]
["5ecbf4e0fe30261b1a0483f7","NCT03418688","2018-09-10","Cortexyme","CRTX","Active, not recruiting","A Multiple Ascending Dose Study of COR388","Cor-388",null,"Yes","['Cor-388']","Unknown",null,"Phase 1",2,36,"Anticipated","2018-03-06","2018-09-15","AUC","Area Under The Curve",{"$nulls":3},"The study is a randomized, double-blind, placebo-controlled, multiple ascending dose study to assess the safety and tolerability of ascending repeat doses of COR388 HCl in older healthy male and female subjects and a cohort of Alzheimer's disease subjects.","The study will enroll 3 cohorts of 8 healthy subjects â‰¥55 and â‰¤80 years of age at the Clinical Pharmacology Unit (CPU) and 1 cohort of 12 AD subjects â‰¥55 and â‰¤80 years of age. Subjects in cohorts 1-3 will receive the study drug or placebo for 10 consecutive days while confined to the CPU. AD patients in cohort 4 will receive the study drug or placebo for 28 days as outpatient. Blood samples samples will be collected for pharmacokinetic measurements.","A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study of COR388 in Older Healthy Volunteers and Patients With Alzheimer's Disease","COR388-002","Alzheimer Disease","Alzheimer Disease","Neurocognitive Disorders","Central Nervous System","Active Comparator|Placebo Comparator","COR388|Placebo","Increasing doses of COR388 will be administered for 10 days in cohorts 1-3 and for 28 days in cohort 4.|Matching placebo capsules will be administered for 10 days in cohorts 1-3 and for 28 days in cohort 4.","Drug","COR388|Placebo","COR388 administered for 10 or 28 days.|Placebo administered for 10 or 28 days.","COR388 HCl","COR388|Placebo","\n\n * Male or female subjects â‰¥55 years to â‰¤80 years of age, at the time of consent;\n * Males of reproductive potential must agree to use double-barrier contraceptive measures or avoid intercourse from the first dose of study drug through 90 days after the last dose of study drug.\n * Females of child-bearing potential must be non-lactating, have negative serum pregnancy test results at Screening and negative urine pregnancy test results at Day -1; agree to use double-barrier or hormonal contraceptive measures or avoid intercourse from Day -10 through 28 days after the last dose of study drug.\n * Stable doses of medications used for stable chronic illnesses that are not prohibited by the protocol are allowed as long as the dose has been stable for 30 days prior to Screening, and no changes are expected during participation in the study;\n * Body mass index â‰¥19 kg/m2 to â‰¤35 kg/m2 at Screening;\n * Good general health as determined by medical history, physical examination, laboratory reports, and 12-lead ECG prior to enrollment;\n * Non-smoker and non-tobacco user for a minimum of 6 months prior to the first admission and for the duration of the study;\n * Able to swallow capsules;\n * Fluent in, and able to read and comprehend, the English language;\n\nCohort 4 Only:\n\n * Must have probable AD according to the NINDS-ADRD criteria; and an MMSE-2 score â‰¥14 and â‰¤25;\n * Must have moderate to severe periodontitis according to the CDC-AAP criteria as determined by the study dentist during the screening oral examination;\n * If applicable, have a primary caregiver willing to accept responsibility for supervising the treatment (eg, administering study drug) and assessing the condition of the subject throughout the study in accordance with all protocol requirements.\n * Provide, if mentally competent and willing, written informed consent. If the subject is not able to provide written informed consent, written informed consent must be obtained from a legally authorized representative on the subject's behalf, and verbal assent may be obtained from the subject. In addition, if the subject has a caregiver, the caregiver will be required to provide written informed consent prior to the subject's participation in the study.\n\n","\n\n * History or current evidence of clinically significant arrhythmia, heart failure, or hypotension in the Investigator's judgment;\n * History or current evidence of clinically significant liver disease in the Investigator's judgment;\n * Evidence of renal insufficiency defined as an estimated glomerular filtration rate <50 mL/min/1.73m2 at Screening;\n * Subjects who received any treatment for periodontitis in the last 90 days including systemic or local antibiotics (eg, PerioChipÂ®), scaling, root planing, or other surgical treatments;\n * Uncontrolled medical or psychiatric illness, uncontrolled seizure disorder, or history of major stroke;\n * Active, or recent history of, systemic infection within 30 days prior to Screening that required treatment with antibiotics for longer than 1 week;\n * History or current evidence of psychiatric or emotional problems that would invalidate giving informed consent or limit the ability of the subject to comply with study requirements;\n * History of systemic allergic reaction to any drug that is considered significant by the Investigator;\n * History of alcohol or drug abuse or dependence within 12 months of Screening, as determined by the Investigator;\n * Positive alcohol screen at Screening or on Day -1;\n * Positive urine screen for prohibited drugs\n * Positive blood screen for human immunodeficiency virus (1 and 2), hepatitis B surface antigen, or hepatitis C virus antibodies at Screening;\n * Any conditions that, in the opinion of the Investigator, would make the subject unsuitable for enrollment, could interfere with the subject's participation in or completion of the study, or could interfere with interpretation of study results;\n * Abnormal results of screening laboratory tests, ECG, or MRI of the brain deemed clinically significant by the Investigator;\n * The use of any prohibited medication that cannot be stopped or replaced safely, based on the judgment of the Investigator; or\n * Participation in another investigational new drug research study involving small molecule drugs within 30 days or biological drugs within 60 days prior to the first dose of study drug.",{"$nulls":4},"Actual","2018-02-01","Actual","Anticipated","2018-10-15","Anticipated","2018-09-01","2018-01-26","2018-01-26","2018-09-07","Yes",null,"Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","55 Years","80 Years","All",null,"Yes","No",{"$nulls":3},"Yes","No",{"$nulls":19},"AUC|Cmax|Tmax","Area under the concentration-time curve|Maximum observed drug concentration during a dosing interval|Time to Cmax","Day 1 and Day 10",{"$nulls":6},"San Diego, California, United States, 92103|Orlando, Florida, United States, 32806|Cincinnati, Ohio, United States, 45227","California|Florida|Ohio","United States","Pacific Research Network|Bioclinica Research|Medpace Clinical Pharmacology Unit",{"$nulls":4},"2018-09-07","2020-05-25T16:40:00.555","2020-05-26T17:10:42.972","NCT03418688"]
["5ecbf4e0feab101b15530a26","NCT03418688","2018-11-07","Cortexyme","CRTX","Completed","A Multiple Ascending Dose Study of COR388","Cor-388",null,"Yes","['Cor-388']","Unknown",null,"Phase 1",2,33,"Actual","2018-03-06","2018-10-15","AUC","Area Under The Curve",{"$nulls":3},"The study is a randomized, double-blind, placebo-controlled, multiple ascending dose study to assess the safety and tolerability of ascending repeat doses of COR388 HCl in older healthy male and female subjects and a cohort of Alzheimer's disease subjects.","The study will enroll 3 cohorts of 8 healthy subjects â‰¥55 and â‰¤80 years of age at the Clinical Pharmacology Unit (CPU) and 1 cohort of 12 AD subjects â‰¥55 and â‰¤80 years of age. Subjects in cohorts 1-3 will receive the study drug or placebo for 10 consecutive days while confined to the CPU. AD patients in cohort 4 will receive the study drug or placebo for 28 days as outpatient. Blood samples samples will be collected for pharmacokinetic measurements.","A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study of COR388 in Older Healthy Volunteers and Patients With Alzheimer's Disease","COR388-002","Alzheimer Disease","Alzheimer Disease","Neurocognitive Disorders","Central Nervous System","Active Comparator|Placebo Comparator","COR388|Placebo","Increasing doses of COR388 will be administered for 10 days in cohorts 1-3 and for 28 days in cohort 4.|Matching placebo capsules will be administered for 10 days in cohorts 1-3 and for 28 days in cohort 4.","Drug","COR388|Placebo","COR388 administered for 10 or 28 days.|Placebo administered for 10 or 28 days.","COR388 HCl","COR388|Placebo","\n\n * Male or female subjects â‰¥55 years to â‰¤80 years of age, at the time of consent;\n * Males of reproductive potential must agree to use double-barrier contraceptive measures or avoid intercourse from the first dose of study drug through 90 days after the last dose of study drug.\n * Females of child-bearing potential must be non-lactating, have negative serum pregnancy test results at Screening and negative urine pregnancy test results at Day -1; agree to use double-barrier or hormonal contraceptive measures or avoid intercourse from Day -10 through 28 days after the last dose of study drug.\n * Stable doses of medications used for stable chronic illnesses that are not prohibited by the protocol are allowed as long as the dose has been stable for 30 days prior to Screening, and no changes are expected during participation in the study;\n * Body mass index â‰¥19 kg/m2 to â‰¤35 kg/m2 at Screening;\n * Good general health as determined by medical history, physical examination, laboratory reports, and 12-lead ECG prior to enrollment;\n * Non-smoker and non-tobacco user for a minimum of 6 months prior to the first admission and for the duration of the study;\n * Able to swallow capsules;\n * Fluent in, and able to read and comprehend, the English language;\n\nCohort 4 Only:\n\n * Must have probable AD according to the NINDS-ADRD criteria; and an MMSE-2 score â‰¥14 and â‰¤25;\n * Must have moderate to severe periodontitis according to the CDC-AAP criteria as determined by the study dentist during the screening oral examination;\n * If applicable, have a primary caregiver willing to accept responsibility for supervising the treatment (eg, administering study drug) and assessing the condition of the subject throughout the study in accordance with all protocol requirements.\n * Provide, if mentally competent and willing, written informed consent. If the subject is not able to provide written informed consent, written informed consent must be obtained from a legally authorized representative on the subject's behalf, and verbal assent may be obtained from the subject. In addition, if the subject has a caregiver, the caregiver will be required to provide written informed consent prior to the subject's participation in the study.\n\n","\n\n * History or current evidence of clinically significant arrhythmia, heart failure, or hypotension in the Investigator's judgment;\n * History or current evidence of clinically significant liver disease in the Investigator's judgment;\n * Evidence of renal insufficiency defined as an estimated glomerular filtration rate <50 mL/min/1.73m2 at Screening;\n * Subjects who received any treatment for periodontitis in the last 90 days including systemic or local antibiotics (eg, PerioChipÂ®), scaling, root planing, or other surgical treatments;\n * Uncontrolled medical or psychiatric illness, uncontrolled seizure disorder, or history of major stroke;\n * Active, or recent history of, systemic infection within 30 days prior to Screening that required treatment with antibiotics for longer than 1 week;\n * History or current evidence of psychiatric or emotional problems that would invalidate giving informed consent or limit the ability of the subject to comply with study requirements;\n * History of systemic allergic reaction to any drug that is considered significant by the Investigator;\n * History of alcohol or drug abuse or dependence within 12 months of Screening, as determined by the Investigator;\n * Positive alcohol screen at Screening or on Day -1;\n * Positive urine screen for prohibited drugs\n * Positive blood screen for human immunodeficiency virus (1 and 2), hepatitis B surface antigen, or hepatitis C virus antibodies at Screening;\n * Any conditions that, in the opinion of the Investigator, would make the subject unsuitable for enrollment, could interfere with the subject's participation in or completion of the study, or could interfere with interpretation of study results;\n * Abnormal results of screening laboratory tests, ECG, or MRI of the brain deemed clinically significant by the Investigator;\n * The use of any prohibited medication that cannot be stopped or replaced safely, based on the judgment of the Investigator; or\n * Participation in another investigational new drug research study involving small molecule drugs within 30 days or biological drugs within 60 days prior to the first dose of study drug.",{"$nulls":4},"Actual","2018-02-01","Actual","Actual","2018-10-15","Actual","2018-11-01","2018-01-26","2018-01-26","2018-11-05","Yes",null,"Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","55 Years","80 Years","All",null,"Yes","No",{"$nulls":3},"Yes","No",{"$nulls":19},"AUC|Cmax|Tmax","Area under the concentration-time curve|Maximum observed drug concentration during a dosing interval|Time to Cmax","Day 1 and Day 10",{"$nulls":6},"San Diego, California, United States, 92103|Orlando, Florida, United States, 32806|Cincinnati, Ohio, United States, 45227","California|Florida|Ohio","United States","Pacific Research Network|Bioclinica Research|Medpace Clinical Pharmacology Unit",{"$nulls":4},"2018-11-05","2020-05-25T16:40:00.710","2020-05-26T17:10:42.972","NCT03418688"]
["5ecbf4e0e2561b1b11905ef2","NCT03418727","2018-02-01","Ocugen","OCGN","Recruiting","Dry Eye Disease Study With Brimonidine","Brimonidine|Carmellose","ADRA2A Agonist","Yes","['Carmellose']","Unknown",null,"Phase 2",3,90,"Anticipated","2017-09-06","2018-01-01",{"$nulls":5},"To evaluate the tolerability and preliminary efficacy of Brimonidine eye drops (with and without corticosteroid eye drops) for the treatment of Dry Eye Disease (DED).","Subjects will assess their tolerance to the administration of the study drug, utilizing a Visual Analog Scale (VAS). The VAS is a 100-mm horizontal line with verbal descriptors at either end. The VAS ratings will be completed after administration of the study drug on Day 1 (post-dose), Day 28, Day 56, Day 84, and Day 105. Subjects will place a single slash mark across the horizontal line between the end labeled \"completely intolerable\" (0 mm) and \"easily tolerable\" (100mm).","A Randomized, Placebo-Controlled, Double-Blind, Multicenter, Proof-of-Concept Study of Brimonidine Eye Drops for the Treatment of Dry Eye Disease (DED)","OCU-310-DED-2017","Dry Eye","Keratoconjunctivitis Sicca","Conjunctival Diseases","Ophthalmological","Experimental|Placebo Comparator","Study Drug Arm #1|Study Drug Arm #2|Control Arm","Combination Therapy: brimonidine (0.2%) administered as eye drops, followed by corticosteroid eye drops, two times a day (BID) for 12 weeks|Monotherapy: brimonidine (0.2%) administered as eye drops followed by placebo, two times a day (BID) for 12 weeks|Placebo: sodium carboxymethylcellulose (0.25%) administered as eye drops followed by a second application, two time a day (BID) for 12 weeks","Drug","Brimonidine|Corticosteroid Eye Drop|Brimonidine Mono Therapy|sodium carboxymethylcellulose","Two products delivered in sequence twice daily.|Eye drop to be administered after Briomonidine in treatment arm 1|Brimonidine given twice daily along with placebo drops|Placebo given twice daily.",null,"Study Drug Arm #1|Study Drug Arm #2|Control Arm","\n\n 1. Aged 18 years or older.\n 2. Sign and date informed consent form approved by the IRB\n 3. History of Dry Eye Disease\n 4. Objective evidence of DED in at least one eye by having 2 or more of the following 4 signs in the same eye at Screening and Baseline (Day 1) visits:i. Conjunctival staining at >/= 1 (out of a possible score of 6 per eye) ii. Corneal staining at >/= 2 (out of a possible score of 15 per eye) iii. Noninvasive Tear Break-Up Time (NITBUT) at </= 7 seconds iv. Schirmer test at <10mm in 5 minutes\n    \n    \n 5. Symptomatic evidence of DED by having a global symptom score (SANDE) >/= 25 mm at both Screening and Baseline (Day 1) visits\n 6. Intraocular pressure (IOP) >/= 5 mmHg and </= 22 mmHg in each eye\n 7. Women who satisfy one of the following: 1. Are of child-bearing potential (WOCP) who are not pregnant or lactating and who are either abstinent or sexually active on an acceptable method of birth control for at least 4 weeks prior to Visit 1 and throughout the study, OR\n     2. Are post-menopausal or have undergone a sterilization procedure\n    \n    \n\n","\n\n 1.  Allergic to brimonidine, corticosteroids or any similar products, or excipients of brimonidine including benzalkonium chloride (BAK)\n 2.  Use of contact lenses\n 3.  Currently receiving brimonidine or other treatment for glaucoma or ocular hypertension or history of glaucoma surgery.\n 4.  Receiving or have received any experimental or investigational drug or device within 30 days prior to Screening visit\n 5.  Intraocular pressure <5 mmHg or >22 mmHg in either eye\n 6.  Active ocular infection or history of ocular herpetic keratitis\n 7.  History of neurotrophic keratitis or ocular neuropathic pain\n 8.  Any history of eyelid surgery or intraocular/ocular surgery within the past 3 months\n 9.  Punctal occlusion within 3 months prior to Screening visit or during study\n 10. Corneal epithelial defect larger than 1 mm2 in either eye\n 11. Have active drug/alcohol dependence or abuse history\n 12. Are neonates, pregnant/lactating women, children, institutionalized individuals, or others who may be considered vulnerable populations\n 13. Received corticosteroid-containing eye drops within the past 7 days or systemic corticosteroids/immunosuppressives within the past 3 months\n 14. Received cyclosporine ophthalmic emulsion 0.05% (RestasisÂ®) or lifitegrast ophthalmic solution 5% (Xiidraâ„¢) within 30 days prior to Screening visit\n 15. In the opinion of Investigator or Study Coordinator, be unwilling or unable to comply with study protocol or unable to successfully instill eye drops\n 16. Disease, condition, or disorder that in the judgement of Investigator could confound study assessments or limit compliance to study protocol",{"$nulls":4},"Actual","2018-02-01","Actual","Anticipated","2018-02-01","Anticipated","2018-01-01","2017-10-10","2018-01-25","2018-01-25","No",null,"Interventional","Treatment","Parallel Assignment","Double (Participant, Investigator)","Randomized","18 Years",null,"All",null,"Yes",{"$nulls":4},"Yes","No",{"$nulls":19},"Main Objective (Tolerability)","Subjects will assess their tolerance to the administration of the study drug, utilizing a Visual Analogue Scale (VAS). The VAS is a 100-mm horizontal line with verbal descriptors at either end. The VAS ratings will be completed after administration of the study drug on Day 1 (post-dose), Day 28, Day 56, and Day 84,. Subjects will place a single slash mark across the horizontal line between the end labeled \"completely intolerable\" (0 mm) and \"easily tolerable\" (100mm).","Baseline - Day 84",{"$nulls":3},"kevin.berth@ocugen.com","Kevin Berth",4842373398,"Hoffman Estates, Illinois, United States, 60169 Brenart Eye ClinicYorkville, Illinois, United States, 60560|Salt Lake City, Utah, United States, 84107","Illinois|Utah","United States","Chicago Cornea Consultants|The Eye Institute Of Utah",{"$nulls":3},"Kevin Berth","2018-01-25","2020-05-25T16:40:00.839","2020-05-26T17:10:42.972","NCT03418727"]
["5ecbf4e011702c1b1b916c03","NCT03418727","2018-07-10","Ocugen","OCGN","Completed","Dry Eye Disease Study With Brimonidine","Brimonidine|Carmellose","ADRA2A Agonist","Yes","['Carmellose']","Unknown",null,"Phase 2",3,84,"Actual","2017-09-06","2018-03-29",{"$nulls":5},"To evaluate the tolerability and preliminary efficacy of Brimonidine eye drops (with and without corticosteroid eye drops) for the treatment of Dry Eye Disease (DED).","Subjects will assess their tolerance to the administration of the study drug, utilizing a Visual Analog Scale (VAS). The VAS is a 100-mm horizontal line with verbal descriptors at either end. The VAS ratings will be completed after administration of the study drug on Day 1 (post-dose), Day 28, Day 56, Day 84, and Day 105. Subjects will place a single slash mark across the horizontal line between the end labeled \"completely intolerable\" (0 mm) and \"easily tolerable\" (100mm).","A Randomized, Placebo-Controlled, Double-Blind, Multicenter, Proof-of-Concept Study of Brimonidine Eye Drops for the Treatment of Dry Eye Disease (DED)","OCU-310-DED-2017","Dry Eye","Keratoconjunctivitis Sicca","Conjunctival Diseases","Ophthalmological","Experimental|Placebo Comparator","Study Drug Arm #1|Study Drug Arm #2|Control Arm","Combination Therapy: brimonidine (0.2%) administered as eye drops, followed by corticosteroid eye drops, two times a day (BID) for 12 weeks|Monotherapy: brimonidine (0.2%) administered as eye drops followed by placebo, two times a day (BID) for 12 weeks|Placebo: sodium carboxymethylcellulose (0.25%) administered as eye drops followed by a second application, two time a day (BID) for 12 weeks","Drug","Brimonidine|Corticosteroid Eye Drop|Brimonidine Mono Therapy|sodium carboxymethylcellulose","Two products delivered in sequence twice daily.|Eye drop to be administered after Briomonidine in treatment arm 1|Brimonidine given twice daily along with placebo drops|Placebo given twice daily.",null,"Study Drug Arm #1|Study Drug Arm #2|Control Arm","\n\n 1. Aged 18 years or older.\n 2. Sign and date informed consent form approved by the IRB\n 3. History of Dry Eye Disease\n 4. Objective evidence of DED in at least one eye by having 2 or more of the following 4 signs in the same eye at Screening and Baseline (Day 1) visits:i. Conjunctival staining at >/= 1 (out of a possible score of 6 per eye) ii. Corneal staining at >/= 2 (out of a possible score of 15 per eye) iii. Noninvasive Tear Break-Up Time (NITBUT) at </= 7 seconds iv. Schirmer test at <10mm in 5 minutes\n    \n    \n 5. Symptomatic evidence of DED by having a global symptom score (SANDE) >/= 25 mm at both Screening and Baseline (Day 1) visits\n 6. Intraocular pressure (IOP) >/= 5 mmHg and </= 22 mmHg in each eye\n 7. Women who satisfy one of the following: 1. Are of child-bearing potential (WOCP) who are not pregnant or lactating and who are either abstinent or sexually active on an acceptable method of birth control for at least 4 weeks prior to Visit 1 and throughout the study, OR\n     2. Are post-menopausal or have undergone a sterilization procedure\n    \n    \n\n","\n\n 1.  Allergic to brimonidine, corticosteroids or any similar products, or excipients of brimonidine including benzalkonium chloride (BAK)\n 2.  Use of contact lenses\n 3.  Currently receiving brimonidine or other treatment for glaucoma or ocular hypertension or history of glaucoma surgery.\n 4.  Receiving or have received any experimental or investigational drug or device within 30 days prior to Screening visit\n 5.  Intraocular pressure <5 mmHg or >22 mmHg in either eye\n 6.  Active ocular infection or history of ocular herpetic keratitis\n 7.  History of neurotrophic keratitis or ocular neuropathic pain\n 8.  Any history of eyelid surgery or intraocular/ocular surgery within the past 3 months\n 9.  Punctal occlusion within 3 months prior to Screening visit or during study\n 10. Corneal epithelial defect larger than 1 mm2 in either eye\n 11. Have active drug/alcohol dependence or abuse history\n 12. Are neonates, pregnant/lactating women, children, institutionalized individuals, or others who may be considered vulnerable populations\n 13. Received corticosteroid-containing eye drops within the past 7 days or systemic corticosteroids/immunosuppressives within the past 3 months\n 14. Received cyclosporine ophthalmic emulsion 0.05% (RestasisÂ®) or lifitegrast ophthalmic solution 5% (Xiidraâ„¢) within 30 days prior to Screening visit\n 15. In the opinion of Investigator or Study Coordinator, be unwilling or unable to comply with study protocol or unable to successfully instill eye drops\n 16. Disease, condition, or disorder that in the judgement of Investigator could confound study assessments or limit compliance to study protocol",{"$nulls":4},"Actual","2018-02-01","Actual","Actual","2018-03-29","Actual","2018-07-01","2017-10-10","2018-01-25","2018-07-09","No",null,"Interventional","Treatment","Parallel Assignment","Double (Participant, Investigator)","Randomized","18 Years",null,"All",null,"Yes",{"$nulls":4},"Yes","No",{"$nulls":19},"Main Objective (Tolerability)","Subjects will assess their tolerance to the administration of the study drug, utilizing a Visual Analogue Scale (VAS). The VAS is a 100-mm horizontal line with verbal descriptors at either end. The VAS ratings will be completed after administration of the study drug on Day 1 (post-dose), Day 28, Day 56, and Day 84,. Subjects will place a single slash mark across the horizontal line between the end labeled \"completely intolerable\" (0 mm) and \"easily tolerable\" (100mm).","Baseline - Day 84",{"$nulls":6},"Hoffman Estates, Illinois, United States, 60169 Brenart Eye ClinicYorkville, Illinois, United States, 60560|Salt Lake City, Utah, United States, 84107","Illinois|Utah","United States","Chicago Cornea Consultants|The Eye Institute Of Utah",{"$nulls":3},"Kevin Berth","2018-07-09","2020-05-25T16:40:00.710","2020-05-26T17:10:42.972","NCT03418727"]
["5ecbf4e2fe30261b1a0483fb","NCT03419403","2018-02-05","AbbVie","ABBV","Not yet recruiting","A Study for Management of Ocular Side Effects in Subjects With Glioblastoma Receiving Depatuxizumab Mafodotin","Temozolomide|Vorsetuzumab mafodotin|Epinephrine","DNA Mtase Inhibitor|Tubulin Inhibitor|Mitosis Inhibitor|ADRB Agonist","Yes","['Vorsetuzumab mafodotin']","Unknown",null,"Phase 3",3,90,"Anticipated","2018-03-15","2019-09-16",{"$nulls":5},"This study will evaluate the effect of several ophthalmologic prophylactic treatment strategies for the management of ocular side effects (OSEs) in participants with epidermal growth factor receptor (EGFR)-amplified glioblastoma (GBM) who are being treated with depatuxizumab mafodotin (ABT-414). The study will include 2 phases during the treatment period: chemoradiation therapy (radiation plus temozolomide [RT/TMZ]) and adjuvant therapy (TMZ ). All participants will receive depatuxizumab mafodotin during both phases of the treatment period plus 1 of 3 prophylactic ophthalmologic treatments (standard steroids [SS], standard steroids with vasoconstrictors and cold compress [SS/VC], and enhanced steroids with vasoconstrictors and cooling compress [ES/VC]).",null,"A Study for Management of Ocular Side Effects in Subjects With EGFR-Amplified Glioblastoma Receiving Depatuxizumab Mafodotin (ABT-414)","M16-534","Cancer - Glioblastoma","Glioblastoma","Oncology Solid Tumor","Oncology","Experimental","Arm B: Standard Steroids + Vasoconstrictor + Cold Compress|Arm A: Standard Steroid (SS)|Arm C: Enhanced Steroids+Vasoconstrictor+Cold Compress (ES/VC)","Arm B: Steroid eye drop plus vasoconstrictor eye drop and cold compress plus depatuxizumab mafodotin during both the chemoradiation therapy (RT and TMZ) and the adjuvant therapy [TMZ] periods of this study.|Arm A: Steroid Eye Drops plus depatuxizumab mafodotin during both the chemoradiation therapy (radiation [RT] and temozolomide [TMZ]) and the adjuvant therapy [TMZ] periods of this study.|Arm C: Steroid Eye Drop plus ophthalmic steroid ointment plus vasoconstrictor eye drop and cold compresses plus depatuxizumab mafodotin during both the chemoradiation therapy (RT and TMZ) and the adjuvant therapy [TMZ] periods of this study.","Drug","Steroid eye drop|Radiation: Radiation|Temozolomide|depatuxizumab mafodotin|Vasoconstrictor eye drop|Ophthalmic steroid ointment","solution, eye drop|radiation|oral|infusion|ointment","ABT-414\ncold compresscold compress|ABT-414","Arm B: Standard Steroids + Vasoconstrictor + Cold Compress|Arm A: Standard Steroid (SS)|Arm C: Enhanced Steroids+Vasoconstrictor+Cold Compress (ES/VC)","\n\n * Newly diagnosed glioblastoma (GBM) histologically proven, World Health Organization (WHO) grade IV GBM or WHO grade IV gliosarcoma.\n * Tumors must demonstrate epidermal growth factor receptor (EGFR) amplification.\n * Tumors must be supratentorial in location.\n * Participant must have recovered from the effects of surgery, postoperative infection, and other complications; has no significant post-operative hemorrhage.\n * Participant has a Karnofsky performance status (KPS) of 70 or higher.\n * Participant has adequate bone marrow, renal, and hepatic function.\n * Electrocardiogram without evidence of acute cardiac ischemia <= 21 days prior to randomization.\n * Participant has a life expectancy of >= 3 months.\n\n","\n\n * Participants with newly diagnosed GBM: has received prior chemotherapy or radiotherapy for cancer of the head and neck region; has received prior treatment with Gliadel wafers or any other intratumoral or intracavitary treatment.\n * Participant has hypersensitivity to any component of TMZ or dacarbazine.\n * Participant has received anti-cancer therapy (including chemotherapy, immunotherapy, radiotherapy, hormonal, biologic, or any investigational therapy) prior to Study Day 1.\n * Participant has clinically significant uncontrolled condition(s) as described in the protocol.\n * Participant has any medical condition which in the opinion of the investigator places the participant at an unacceptably high risk for toxicities.\n * Participant has had another active malignancy within the past 3 years except for any cancer considered cured or non-melanoma carcinoma of the skin.\n * Participant has a history of herpetic keratitis.\n * Participant is not suitable for receiving ocular steroids with conditions as described in the protocol.\n * Participant has had laser-assisted in situ keratomileusis (LASIK) procedure within the last 1 year or cataract surgery within the last 3 months.\n * Participant has a visual condition that compromises the ability to accurately measure visual acuity or assess visual activities of daily living (vADLs).","EGFR","epidermal growth factor receptor","Protein","Ovary, Breast, Lung","Actual","2018-02-05","Actual","Anticipated","2019-12-01","Anticipated","2018-01-01","2018-01-26","2018-01-26","2018-01-26","No","Glioblastoma Multiforme (GBM)\ncancer\nchemoradiation therapy\nepidermal growth factor receptor-amplified glioblastoma\nradiation\ntemozolomide","Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No","Undecided",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2017-003171-64","EudraCT Number","Participants who Require a Change in Ocular Side Effect (OSE) Management","Ocular Side Effect (OSE) management is defined as a participant with >= 3-line loss (+ 0.3 on LogMAR scale or equivalent) of best corrected visual acuity from baseline (with prescription at baseline for those using corrective lens), or >= Grade 3 OSE severity on the Corneal Epithelial Adverse Event","CEAE scale.","Cumulative Dose of Depatuxizumab Mafodotin|Change on LogMAR Scale after Bandage Contact Lenses (BCL) Intervention|Time to OSE Symptom Resolution after Drug Discontinuation (reversibility)|Time to BCL Intervention|Participants that recover to <3-line Loss of Visual Acuity from Baseline (+0.3 LogMAR) after BCL Intervention|CEAE Grade|Time to Re-initiation of Depatuxizumab Mafodotin after Dose Interruption|Participants with Depatuxizumab Mafodotin Dose Interruptions due to OSEs|Participants with Depatuxizumab Mafodotin Dose Reductions due to OSEs|Maximum Change from Baseline on LogMAR Scale","Cumulative dose of depatuxizumab mafodotin administered (mg/kg).|Change on LogMAR Scale from last assessment prior to BCL intervention to 2 weeks after BCL intervention. The LogMAR scale is the validated tool used in ophthalmology clinical trials to evaluate change in visual acuity.|Time from discontinuation of depatuxizumab mafodotin to OSE symptom resolution (reversibility).|Time to initiation of bandage contact lenses (BCL) intervention.|Recovery is defined as return to <3-line loss of visual acuity from baseline (+0.3 LogMAR) after BCL intervention.|The corneal epithelial adverse event (CEAE) rating scale is designed to describe the overall severity symptoms associated with antibody-drug conjugate (ADC)-related corneal epitheliopathy under a single CEAE grade, while capturing additional information about specific domains (ocular discomfort, photophobia, and blurred vision/visual acuity) that are commonly affected.|Time from dose interruption until re-initiation or permanent discontinuation of depatuxizumab mafodotin.|Participants with dose interruptions of depatuxizumab mafodotin due to ocular side effects (OSEs).|Dose reductions of depatuxizumab mafodotin initiated due to OSEs.|The Logarithm of the Minimum Angle of Resolution (LogMAR) scale is the validated tool used in ophthalmology clinical trials to evaluate change in visual acuity.","Up to approximately 18 weeks after initial dose of depatuxizumab mafodotin|Up to approximately 3 years after initial dose of depatuxizumab mafodotin","abbvieclinicaltrials@abbvie.com","ABBVIE CALL CENTER","847.283.8955","Saint Leonards, New South Wales, Australia, 2065|Herston, Queensland, Australia, 4029|Aalborg, Denmark, 9000 RigshospitaletCopenhagen, Denmark, 2100|Newcastle Upon Tyne, United Kingdom, Ne7 7Dn|Los Angeles, California, United States, 90033|Tampa, Florida, United States, 33612|Chicago, Illinois, United States, 60611 Northshore Univ HealthsystemSkokie, Illinois, United States, 60077 Cdh-Delnor Health SystemWarrenville, Illinois, United States, 60555|New York, New York, United States, 10032|Charlotte, North Carolina, United States, 28204 Duke Univ Med CtrDurham, North Carolina, United States, 27710|Houston, Texas, United States, 77030 Scott & White Mem Hosp & ClinTemple, Texas, United States, 76508","California|Florida|Illinois|New York|North Carolina|Texas","Australia|Denmark|United Kingdom|United States","New South Wales Royal North Shore Hospital|Queensland Royal Brisbane Women's Hosp|Aalborg University Hospital|Freeman Hospital|Usc|Moffitt Cancer Center|Northwestern Medical|Columbia University Medical Center-Ob/Gyn Department|Levine Cancer Ins, Carolina Me|Ut Health Science Ctr-Houston",{"$nulls":3},"AbbVie Inc.","2018-01-26","2020-05-25T16:40:02.707","2020-05-26T17:10:42.972","NCT03419403"]
["5ecbf4e2e2561b1b11905ef5","NCT03419403","2018-02-20","AbbVie","ABBV","Not yet recruiting","A Study for Management of Ocular Side Effects in Subjects With Glioblastoma Receiving Depatuxizumab Mafodotin","Temozolomide|Vorsetuzumab mafodotin|Epinephrine","DNA Mtase Inhibitor|Tubulin Inhibitor|Mitosis Inhibitor|ADRB Agonist","Yes","['Vorsetuzumab mafodotin']","Unknown",null,"Phase 3",3,90,"Anticipated","2018-03-15","2019-09-16",{"$nulls":5},"This study will evaluate the effect of several ophthalmologic prophylactic treatment strategies for the management of ocular side effects (OSEs) in participants with epidermal growth factor receptor (EGFR)-amplified glioblastoma (GBM) who are being treated with depatuxizumab mafodotin (ABT-414). The study will include 2 phases during the treatment period: chemoradiation therapy (radiation plus temozolomide [RT/TMZ]) and adjuvant therapy (TMZ ). All participants will receive depatuxizumab mafodotin during both phases of the treatment period plus 1 of 3 prophylactic ophthalmologic treatments (standard steroids [SS], standard steroids with vasoconstrictors and cold compress [SS/VC], and enhanced steroids with vasoconstrictors and cooling compress [ES/VC]).",null,"Phase 3b Study for Management of Ocular Side Effects in Subjects With EGFR-amplified Glioblastoma Receiving Depatuxizumab Mafodotin (ABT-414)","M16-534","Cancer - Glioblastoma","Glioblastoma","Oncology Solid Tumor","Oncology","Experimental","Arm B: Standard Steroids + Vasoconstrictor + Cold Compress|Arm A: Standard Steroid (SS)|Arm C: Enhanced Steroids+Vasoconstrictor+Cold Compress (ES/VC)","Arm B: Steroid eye drop plus vasoconstrictor eye drop and cold compress plus depatuxizumab mafodotin during both the chemoradiation therapy (RT and TMZ) and the adjuvant therapy [TMZ] periods of this study.|Arm A: Steroid Eye Drops plus depatuxizumab mafodotin during both the chemoradiation therapy (radiation [RT] and temozolomide [TMZ]) and the adjuvant therapy [TMZ] periods of this study.|Arm C: Steroid Eye Drop plus ophthalmic steroid ointment plus vasoconstrictor eye drop and cold compresses plus depatuxizumab mafodotin during both the chemoradiation therapy (RT and TMZ) and the adjuvant therapy [TMZ] periods of this study.","Drug","Steroid eye drop|Radiation: Radiation|Temozolomide|depatuxizumab mafodotin|Vasoconstrictor eye drop|Ophthalmic steroid ointment","solution, eye drop|radiation|oral|infusion|ointment","ABT-414\ncold compresscold compress|ABT-414","Arm B: Standard Steroids + Vasoconstrictor + Cold Compress|Arm A: Standard Steroid (SS)|Arm C: Enhanced Steroids+Vasoconstrictor+Cold Compress (ES/VC)","\n\n * Newly diagnosed glioblastoma (GBM) histologically proven, World Health Organization (WHO) grade IV GBM or WHO grade IV gliosarcoma.\n * Tumors must demonstrate epidermal growth factor receptor (EGFR) amplification.\n * Tumors must be supratentorial in location.\n * Participant must have recovered from the effects of surgery, postoperative infection, and other complications; has no significant post-operative hemorrhage.\n * Participant has a Karnofsky performance status (KPS) of 70 or higher.\n * Participant has adequate bone marrow, renal, and hepatic function.\n * Electrocardiogram without evidence of acute cardiac ischemia <= 21 days prior to randomization.\n * Participant has a life expectancy of >= 3 months.\n\n","\n\n * Participants with newly diagnosed GBM: has received prior chemotherapy or radiotherapy for cancer of the head and neck region; has received prior treatment with Gliadel wafers or any other intratumoral or intracavitary treatment.\n * Participant has hypersensitivity to any component of TMZ or dacarbazine.\n * Participant has received anti-cancer therapy (including chemotherapy, immunotherapy, radiotherapy, hormonal, biologic, or any investigational therapy) prior to Study Day 1.\n * Participant has clinically significant uncontrolled condition(s) as described in the protocol.\n * Participant has any medical condition which in the opinion of the investigator places the participant at an unacceptably high risk for toxicities.\n * Participant has had another active malignancy within the past 3 years except for any cancer considered cured or non-melanoma carcinoma of the skin.\n * Participant has a history of herpetic keratitis.\n * Participant is not suitable for receiving ocular steroids with conditions as described in the protocol.\n * Participant has had laser-assisted in situ keratomileusis (LASIK) procedure within the last 1 year or cataract surgery within the last 3 months.\n * Participant has a visual condition that compromises the ability to accurately measure visual acuity or assess visual activities of daily living (vADLs).","EGFR","epidermal growth factor receptor","Protein","Ovary, Breast, Lung","Actual","2018-02-05","Actual","Anticipated","2019-12-01","Anticipated","2018-02-01","2018-01-26","2018-01-26","2018-02-16","No","Glioblastoma Multiforme (GBM)\ncancer\nchemoradiation therapy\nepidermal growth factor receptor-amplified glioblastoma\nradiation\ntemozolomide","Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No","Undecided",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2017-003171-64","EudraCT Number","Participants who Require a Change in Ocular Side Effect (OSE) Management","Ocular Side Effect (OSE) management is defined as a participant with >= 3-line loss (+ 0.3 on LogMAR scale or equivalent) of best corrected visual acuity from baseline (with prescription at baseline for those using corrective lens), or >= Grade 3 OSE severity on the Corneal Epithelial Adverse Event","CEAE scale.","Cumulative Dose of Depatuxizumab Mafodotin|Change from Baseline In Logarithm of the Minimum Angle of Resolution (LogMAR) Best Corrected Visual Acuity (BCVA) Scale after Bandage Contact Lenses (BCL) Intervention|Time to OSE Symptom Resolution after Drug Discontinuation (reversibility)|Time to BCL Intervention|Participants that recover to <3-line Loss of Visual Acuity from Baseline (+0.3 LogMAR) after BCL Intervention|Corneal Epithelial Adverse Event (CEAE) Grade|Time to Re-initiation of Depatuxizumab Mafodotin after Dose Interruption|Participants with Depatuxizumab Mafodotin Dose Interruptions due to OSEs|Participants with Depatuxizumab Mafodotin Dose Reductions due to OSEs|Maximum Change from Baseline on LogMAR Scale","Cumulative dose of depatuxizumab mafodotin administered (mg/kg).|Change on LogMAR Scale from last assessment prior to BCL intervention to 2 weeks after BCL intervention. The LogMAR scale measures visual acuity on a continuous scale, with a LogMAR value of 0 equivalent to 20/20 visual acuity. Normal vision is considered to be from -0.2 - 0.1; higher values indicate visual impairment.|Time from discontinuation of depatuxizumab mafodotin to OSE symptom resolution (reversibility).|Time to initiation of bandage contact lenses (BCL) intervention.|Recovery is defined as return to <3-line loss of visual acuity from baseline (+0.3 LogMAR) after BCL intervention.|The corneal epithelial adverse event (CEAE) rating scale is designed to record symptoms associated with corneal epitheliopathy caused by antibody-drug conjugates and to grade the severity of findings. The overall CEAE grade is measured on a scale of 0 to 5, with higher values being more severe, reflecting the impact of corneal abnormalities on visual activities of daily living (ADLs). Additional detailed information is collected for specific domains that are commonly affected, with the following ranges (each in order of increasing severity): ocular discomfort (0 - 4), photophobia (0 - 3), and reading (1 - 3).|Time from dose interruption until re-initiation or permanent discontinuation of depatuxizumab mafodotin.|Participants with dose interruptions of depatuxizumab mafodotin due to ocular side effects (OSEs).|Dose reductions of depatuxizumab mafodotin initiated due to OSEs.|The Logarithm of the Minimum Angle of Resolution (LogMAR) scale measures visual acuity on a continuous scale, with a LogMAR value of 0 equivalent to 20/20 visual acuity. Normal vision is considered to be from -0.2 - 0.1; higher values indicate visual impairment.","Up to approximately 18 weeks after initial dose of depatuxizumab mafodotin|Up to approximately 3 years after initial dose of depatuxizumab mafodotin","abbvieclinicaltrials@abbvie.com","ABBVIE CALL CENTER","847.283.8955","Saint Leonards, New South Wales, Australia, 2065|Herston, Queensland, Australia, 4029|Aalborg, Denmark, 9000 RigshospitaletCopenhagen, Denmark, 2100|Newcastle Upon Tyne, United Kingdom, Ne7 7Dn|Los Angeles, California, United States, 90033|Tampa, Florida, United States, 33612|Chicago, Illinois, United States, 60611 Northshore Univ HealthsystemSkokie, Illinois, United States, 60077 Cdh-Delnor Health SystemWarrenville, Illinois, United States, 60555|New York, New York, United States, 10032|Charlotte, North Carolina, United States, 28204 Duke Univ Med CtrDurham, North Carolina, United States, 27710|Houston, Texas, United States, 77030 Scott & White Mem Hosp & ClinTemple, Texas, United States, 76508","California|Florida|Illinois|New York|North Carolina|Texas","Australia|Denmark|United Kingdom|United States","New South Wales Royal North Shore Hospital|Queensland Royal Brisbane Women's Hosp|Aalborg University Hospital|Freeman Hospital|Usc|Moffitt Cancer Center|Northwestern Medical|Columbia University Medical Center-Ob/Gyn Department|Levine Cancer Ins, Carolina Me|Ut Health Science Ctr-Houston",{"$nulls":3},"AbbVie Inc.","2018-02-16","2020-05-25T16:40:02.378","2020-05-26T17:10:42.972","NCT03419403"]
["5ecbf4e211702c1b1b916c07","NCT03419403","2018-06-07","AbbVie","ABBV","Not yet recruiting","A Study for Management of Ocular Side Effects in Subjects With Glioblastoma Receiving Depatuxizumab Mafodotin","Temozolomide|Vorsetuzumab mafodotin|Epinephrine","DNA Mtase Inhibitor|Tubulin Inhibitor|Mitosis Inhibitor|ADRB Agonist","Yes","['Vorsetuzumab mafodotin']","Unknown",null,"Phase 3",3,90,"Anticipated","2018-06-29","2019-09-16",{"$nulls":5},"This study will evaluate the effect of several ophthalmologic prophylactic treatment strategies for the management of ocular side effects (OSEs) in participants with epidermal growth factor receptor (EGFR)-amplified glioblastoma (GBM) who are being treated with depatuxizumab mafodotin (ABT-414). The study will include 2 phases during the treatment period: chemoradiation therapy (radiation plus temozolomide [RT/TMZ]) and adjuvant therapy (TMZ ). All participants will receive depatuxizumab mafodotin during both phases of the treatment period plus 1 of 3 prophylactic ophthalmologic treatments (standard steroids [SS], standard steroids with vasoconstrictors and cold compress [SS/VC], and enhanced steroids with vasoconstrictors and cooling compress [ES/VC]).",null,"Phase 3b Study for Management of Ocular Side Effects in Subjects With EGFR-amplified Glioblastoma Receiving Depatuxizumab Mafodotin (ABT-414)","M16-534","Glioblastoma Multiforme","Glioblastoma","Oncology Solid Tumor","Oncology","Experimental","Arm B: Standard Steroids + Vasoconstrictor + Cold Compress|Arm A: Standard Steroid (SS)|Arm C: Enhanced Steroids+Vasoconstrictor+Cold Compress (ES/VC)","Arm B: Steroid eye drop plus vasoconstrictor eye drop and cold compress plus depatuxizumab mafodotin during both the chemoradiation therapy (RT and TMZ) and the adjuvant therapy [TMZ] periods of this study.|Arm A: Steroid Eye Drops plus depatuxizumab mafodotin during both the chemoradiation therapy (radiation [RT] and temozolomide [TMZ]) and the adjuvant therapy [TMZ] periods of this study.|Arm C: Steroid Eye Drop plus ophthalmic steroid ointment plus vasoconstrictor eye drop and cold compresses plus depatuxizumab mafodotin during both the chemoradiation therapy (RT and TMZ) and the adjuvant therapy [TMZ] periods of this study.","Drug","Steroid eye drop|Radiation: Radiation|Temozolomide|depatuxizumab mafodotin|Vasoconstrictor eye drop|Ophthalmic steroid ointment","solution, eye drop|radiation|oral|infusion|ointment","ABT-414\ncold compresscold compress|ABT-414","Arm B: Standard Steroids + Vasoconstrictor + Cold Compress|Arm A: Standard Steroid (SS)|Arm C: Enhanced Steroids+Vasoconstrictor+Cold Compress (ES/VC)","\n\n * Newly diagnosed glioblastoma (GBM) histologically proven, World Health Organization (WHO) grade IV GBM or WHO grade IV gliosarcoma.\n * Tumors must demonstrate epidermal growth factor receptor (EGFR) amplification.\n * Tumors must be supratentorial in location.\n * Participant must have recovered from the effects of surgery, postoperative infection, and other complications; has no significant post-operative hemorrhage.\n * Participant has a Karnofsky performance status (KPS) of 70 or higher.\n * Participant has adequate bone marrow, renal, and hepatic function.\n * Electrocardiogram without evidence of acute cardiac ischemia <= 21 days prior to randomization.\n * Participant has a life expectancy of >= 3 months.\n\n","\n\n * Participants with newly diagnosed GBM: has received prior chemotherapy or radiotherapy for cancer of the head and neck region; has received prior treatment with Gliadel wafers or any other intratumoral or intracavitary treatment.\n * Participant has hypersensitivity to any component of TMZ or dacarbazine.\n * Participant has received anti-cancer therapy (including chemotherapy, immunotherapy, radiotherapy, hormonal, biologic, or any investigational therapy) prior to Study Day 1.\n * Participant has clinically significant uncontrolled condition(s) as described in the protocol.\n * Participant has any medical condition which in the opinion of the investigator places the participant at an unacceptably high risk for toxicities.\n * Participant has had another active malignancy within the past 3 years except for any cancer considered cured or non-melanoma carcinoma of the skin.\n * Participant has a history of herpetic keratitis.\n * Participant is not suitable for receiving ocular steroids with conditions as described in the protocol.\n * Participant has had laser-assisted in situ keratomileusis (LASIK) procedure within the last 1 year or cataract surgery within the last 3 months.\n * Participant has a visual condition that compromises the ability to accurately measure visual acuity or assess visual activities of daily living (vADLs).","EGFR","epidermal growth factor receptor","Protein","Ovary, Breast, Lung","Actual","2018-02-05","Actual","Anticipated","2019-09-24","Anticipated","2018-06-01","2018-01-26","2018-01-26","2018-06-05","No","Glioblastoma Multiforme (GBM)\ncancer\nchemoradiation therapy\nepidermal growth factor receptor-amplified glioblastoma\nradiation\ntemozolomide","Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No","Undecided",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2017-003171-64","EudraCT Number","Participants who Require a Change in Ocular Side Effect (OSE) Management","Ocular Side Effect (OSE) management is defined as a participant with >= 3-line loss (+ 0.3 on LogMAR scale or equivalent) of best corrected visual acuity from baseline (with prescription at baseline for those using corrective lens), or >= Grade 3 OSE severity on the Corneal Epithelial Adverse Event","CEAE scale.","Cumulative Dose of Depatuxizumab Mafodotin|Change from Baseline In Logarithm of the Minimum Angle of Resolution (LogMAR) Best Corrected Visual Acuity (BCVA) Scale after Bandage Contact Lenses (BCL) Intervention|Time to OSE Symptom Resolution after Drug Discontinuation (reversibility)|Time to BCL Intervention|Participants that recover to <3-line Loss of Visual Acuity from Baseline (+0.3 LogMAR) after BCL Intervention|Corneal Epithelial Adverse Event (CEAE) Grade|Time to Re-initiation of Depatuxizumab Mafodotin after Dose Interruption|Participants with Depatuxizumab Mafodotin Dose Interruptions due to OSEs|Participants with Depatuxizumab Mafodotin Dose Reductions due to OSEs|Maximum Change from Baseline on LogMAR Scale","Cumulative dose of depatuxizumab mafodotin administered (mg/kg).|Change on LogMAR Scale from last assessment prior to BCL intervention to 2 weeks after BCL intervention. The LogMAR scale measures visual acuity on a continuous scale, with a LogMAR value of 0 equivalent to 20/20 visual acuity. Normal vision is considered to be from -0.2 - 0.1; higher values indicate visual impairment.|Time from discontinuation of depatuxizumab mafodotin to OSE symptom resolution (reversibility).|Time to initiation of bandage contact lenses (BCL) intervention.|Recovery is defined as return to <3-line loss of visual acuity from baseline (+0.3 LogMAR) after BCL intervention.|The corneal epithelial adverse event (CEAE) rating scale is designed to record symptoms associated with corneal epitheliopathy caused by antibody-drug conjugates and to grade the severity of findings. The overall CEAE grade is measured on a scale of 0 to 5, with higher values being more severe, reflecting the impact of corneal abnormalities on visual activities of daily living (ADLs). Additional detailed information is collected for specific domains that are commonly affected, with the following ranges (each in order of increasing severity): ocular discomfort (0 - 4), photophobia (0 - 3), and reading (1 - 3).|Time from dose interruption until re-initiation or permanent discontinuation of depatuxizumab mafodotin.|Participants with dose interruptions of depatuxizumab mafodotin due to ocular side effects (OSEs).|Dose reductions of depatuxizumab mafodotin initiated due to OSEs.|The Logarithm of the Minimum Angle of Resolution (LogMAR) scale measures visual acuity on a continuous scale, with a LogMAR value of 0 equivalent to 20/20 visual acuity. Normal vision is considered to be from -0.2 - 0.1; higher values indicate visual impairment.","Up to approximately 18 weeks after initial dose of depatuxizumab mafodotin|Up to approximately 3 years after initial dose of depatuxizumab mafodotin","abbvieclinicaltrials@abbvie.com","ABBVIE CALL CENTER","847.283.8955","Saint Leonards, New South Wales, Australia, 2065 Calvary Mater Newcastle /Id# 169672Waratah, New South Wales, Australia, 2298|Herston, Queensland, Australia, 4029|Heidelberg, Victoria, Australia, 3084|Copenhagen Ã˜, Hovedstaden, Denmark, 2100|Aalborg, Nordjylland, Denmark, 9000|Heidelberg, Baden-Wuerttemberg, Germany, 69120|Leipzig, Sachsen, Germany, 04103|Hamburg, Germany, 20246 Klinikum Univ Regensburg /Id# 169963Regensburg, Germany, 93042 Universitatsklinikum Tubingen /Id# 169965Tuebingen, Germany, 72076|Amsterdam, Netherlands, 1081 Hv Mc Haaglanden /Id# 170150Leidschendam, Netherlands, 2262 Ba Umc Utrecht /Id# 170149Utrecht, Netherlands, 3584 Cx|Birmingham, United Kingdom, B15 2Th Castle Hill Hospital /Id# 200662Cottingham, United Kingdom, Hu16 5Jq Western General Hospital /Id# 203040Edinburgh, United Kingdom, Eh4 2Xu St. James University Hospital /Id# 200651Leeds, United Kingdom, Ls9 7Tf Freeman Hospital /Id# 200653Newcastle Upon Tyne, United Kingdom, Ne7 7Dn|Los Angeles, California, United States, 90033|Tampa, Florida, United States, 33612|Chicago, Illinois, United States, 60611 Rush University Medical Center /Id# 171003Chicago, Illinois, United States, 60612 Northshore Univ Healthsystem /Id# 164221Evanston, Illinois, United States, 60201 Cdh-Delnor Health System /Id# 169909Warrenville, Illinois, United States, 60555|New York, New York, United States, 10032-3725|Charlotte, North Carolina, United States, 28204 Duke Univ Med Ctr /Id# 170004Durham, North Carolina, United States, 27710|Houston, Texas, United States, 77030 Scott & White Mem Hosp & Clin /Id# 170792Temple, Texas, United States, 76508","California|Florida|Illinois|New York|North Carolina|Texas","Australia|Denmark|Germany|Netherlands|United Kingdom|United States","New South Wales Royal North Shore Hospital /Id# 169673|Queensland Royal Brisbane And Women's Hospital /Id# 169674|Victoria Austin Hospital /Id# 169671|Hovedstaden Rigshospitalet /Id# 170636|Nordjylland Aalborg University Hospital /Id# 168856|Baden-Wuerttemberg Universitaetsklinik Heidelberg /Id# 169970|Sachsen Universitaetsklinikum Leipzig /Id# 169969|Univ Klinik Eppendorf Hamburg /Id# 169971|Vrije Univ Medisch Centrum /Id# 170152|Queen Elizabeth Hospital - Birmingham /Id# 200657|Usc /Id# 164235|Moffitt Cancer Center /Id# 164234|Northwestern Medical /Id# 164231|Columbia Univ Medical Center /Id# 164220|Levine Cancer Ins, Carolina Me /Id# 171271|Ut Health Science Ctr-Houston /Id# 164223",{"$nulls":3},"AbbVie Inc.","2018-06-05","2020-05-25T16:40:02.774","2020-05-26T17:10:42.972","NCT03419403"]
["5ecbf4e2307e3d1b1f8d9e8c","NCT03419403","2018-08-06","AbbVie","ABBV","Recruiting","A Study for Management of Ocular Side Effects in Subjects With Glioblastoma Receiving Depatuxizumab Mafodotin","Temozolomide|Vorsetuzumab mafodotin|Epinephrine","DNA Mtase Inhibitor|Tubulin Inhibitor|Mitosis Inhibitor|ADRB Agonist","Yes","['Vorsetuzumab mafodotin']","Unknown",null,"Phase 3",3,90,"Anticipated","2018-07-19","2019-09-16",{"$nulls":5},"This study will evaluate the effect of several ophthalmologic prophylactic treatment strategies for the management of ocular side effects (OSEs) in participants with epidermal growth factor receptor (EGFR)-amplified glioblastoma (GBM) who are being treated with depatuxizumab mafodotin (ABT-414). The study will include 2 phases during the treatment period: chemoradiation therapy (radiation plus temozolomide [RT/TMZ]) and adjuvant therapy (TMZ ). All participants will receive depatuxizumab mafodotin during both phases of the treatment period plus 1 of 3 prophylactic ophthalmologic treatments (standard steroids [SS], standard steroids with vasoconstrictors and cold compress [SS/VC], and enhanced steroids with vasoconstrictors and cooling compress [ES/VC]).",null,"Phase 3b Study for Management of Ocular Side Effects in Subjects With EGFR-amplified Glioblastoma Receiving Depatuxizumab Mafodotin (ABT-414)","M16-534","Glioblastoma Multiforme","Glioblastoma","Oncology Solid Tumor","Oncology","Experimental","Arm B: Standard Steroids + Vasoconstrictor + Cold Compress|Arm A: Standard Steroid (SS)|Arm C: Enhanced Steroids+Vasoconstrictor+Cold Compress (ES/VC)","Arm B: Steroid eye drop plus vasoconstrictor eye drop and cold compress plus depatuxizumab mafodotin during both the chemoradiation therapy (RT and TMZ) and the adjuvant therapy [TMZ] periods of this study.|Arm A: Steroid Eye Drops plus depatuxizumab mafodotin during both the chemoradiation therapy (radiation [RT] and temozolomide [TMZ]) and the adjuvant therapy [TMZ] periods of this study.|Arm C: Steroid Eye Drop plus ophthalmic steroid ointment plus vasoconstrictor eye drop and cold compresses plus depatuxizumab mafodotin during both the chemoradiation therapy (RT and TMZ) and the adjuvant therapy [TMZ] periods of this study.","Drug","Steroid eye drop|Radiation: Radiation|Temozolomide|depatuxizumab mafodotin|Vasoconstrictor eye drop|Ophthalmic steroid ointment","solution, eye drop|radiation|oral|infusion|ointment","ABT-414\ncold compresscold compress|ABT-414","Arm B: Standard Steroids + Vasoconstrictor + Cold Compress|Arm A: Standard Steroid (SS)|Arm C: Enhanced Steroids+Vasoconstrictor+Cold Compress (ES/VC)","\n\n * Newly diagnosed glioblastoma (GBM) histologically proven, World Health Organization (WHO) grade IV GBM or WHO grade IV gliosarcoma.\n * Tumors must demonstrate epidermal growth factor receptor (EGFR) amplification.\n * Tumors must be supratentorial in location.\n * Participant must have recovered from the effects of surgery, postoperative infection, and other complications; has no significant post-operative hemorrhage.\n * Participant has a Karnofsky performance status (KPS) of 70 or higher.\n * Participant has adequate bone marrow, renal, and hepatic function.\n * Electrocardiogram without evidence of acute cardiac ischemia <= 21 days prior to randomization.\n * Participant has a life expectancy of >= 3 months.\n\n","\n\n * Participants with newly diagnosed GBM: has received prior chemotherapy or radiotherapy for cancer of the head and neck region; has received prior treatment with Gliadel wafers or any other intratumoral or intracavitary treatment.\n * Participant has hypersensitivity to any component of TMZ or dacarbazine.\n * Participant has received anti-cancer therapy (including chemotherapy, immunotherapy, radiotherapy, hormonal, biologic, or any investigational therapy) prior to Study Day 1.\n * Participant has clinically significant uncontrolled condition(s) as described in the protocol.\n * Participant has any medical condition which in the opinion of the investigator places the participant at an unacceptably high risk for toxicities.\n * Participant has had another active malignancy within the past 3 years except for any cancer considered cured or non-melanoma carcinoma of the skin.\n * Participant has a history of herpetic keratitis.\n * Participant is not suitable for receiving ocular steroids with conditions as described in the protocol.\n * Participant has had laser-assisted in situ keratomileusis (LASIK) procedure within the last 1 year or cataract surgery within the last 3 months.\n * Participant has a visual condition that compromises the ability to accurately measure visual acuity or assess visual activities of daily living (vADLs).","EGFR","epidermal growth factor receptor","Protein","Ovary, Breast, Lung","Actual","2018-02-05","Actual","Anticipated","2019-11-21","Anticipated","2018-07-01","2018-01-26","2018-01-26","2018-08-03","No","Glioblastoma Multiforme (GBM)\ncancer\nchemoradiation therapy\nepidermal growth factor receptor-amplified glioblastoma\nradiation\ntemozolomide","Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No","Yes\nAbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2017-003171-64","EudraCT Number","Participants who Require a Change in Ocular Side Effect (OSE) Management","Ocular Side Effect (OSE) management is defined as a participant with >= 3-line loss (+ 0.3 on LogMAR scale or equivalent) of best corrected visual acuity from baseline (with prescription at baseline for those using corrective lens), or >= Grade 3 OSE severity on the Corneal Epithelial Adverse Event","CEAE scale.","Cumulative Dose of Depatuxizumab Mafodotin|Change from Baseline In Logarithm of the Minimum Angle of Resolution (LogMAR) Scale after Bandage Contact Lenses (BCL) Intervention|Time to OSE Symptom Resolution after Drug Discontinuation (reversibility)|Time to BCL Intervention|Participants that recover to <3-line decline from Baseline (< +0.3 LogMAR) in visual acuity after BCL Intervention|Corneal Epithelial Adverse Event (CEAE) Grade|Time to Re-initiation of Depatuxizumab Mafodotin after Dose Interruption|Participants with Depatuxizumab Mafodotin Dose Interruptions due to OSEs|Participants with Depatuxizumab Mafodotin Dose Reductions due to OSEs|Maximum Change from Baseline on LogMAR Scale","Cumulative dose of depatuxizumab mafodotin administered (mg/kg).|Change on LogMAR Scale from last assessment prior to BCL intervention to 2 weeks after BCL intervention. The LogMAR scale measures visual acuity on a continuous scale, with a LogMAR value of 0 equivalent to 20/20 visual acuity. Normal vision is considered to be from -0.2 - 0.1; higher values indicate visual impairment.|Time from discontinuation of depatuxizumab mafodotin to OSE symptom resolution (reversibility).|Time to initiation of bandage contact lenses (BCL) intervention.|Recovery is defined as return to <3-line decline from baseline (< +0.3 LogMAR) in visual acuity after BCL intervention.|The corneal epithelial adverse event (CEAE) rating scale is designed to record symptoms associated with corneal epitheliopathy caused by antibody-drug conjugates and to grade the severity of findings. The overall CEAE grade is measured on a scale of 0 to 5, with higher values being more severe, reflecting the impact of corneal abnormalities on visual activities of daily living (ADLs). Additional detailed information is collected for specific domains that are commonly affected, with the following ranges (each in order of increasing severity): ocular discomfort (0 - 4), photophobia (0 - 3), and reading (1 - 3).|Time from dose interruption until re-initiation or permanent discontinuation of depatuxizumab mafodotin.|Participants with dose interruptions of depatuxizumab mafodotin due to ocular side effects (OSEs).|Dose reductions of depatuxizumab mafodotin initiated due to OSEs.|The Logarithm of the Minimum Angle of Resolution (LogMAR) scale measures visual acuity on a continuous scale, with a LogMAR value of 0 equivalent to 20/20 visual acuity. Normal vision is considered to be from -0.2 - 0.1; higher values indicate visual impairment.","Up to approximately 18 weeks after initial dose of depatuxizumab mafodotin|Up to approximately 3 years after initial dose of depatuxizumab mafodotin","abbvieclinicaltrials@abbvie.com","ABBVIE CALL CENTER","847.283.8955","Saint Leonards, New South Wales, Australia, 2065 Calvary Mater Newcastle /Id# 169672Waratah, New South Wales, Australia, 2298|Herston, Queensland, Australia, 4029|Heidelberg, Victoria, Australia, 3084|Copenhagen Ã˜, Hovedstaden, Denmark, 2100|Aalborg, Nordjylland, Denmark, 9000|Heidelberg, Baden-Wuerttemberg, Germany, 69120|Leipzig, Sachsen, Germany, 04103|Hamburg, Germany, 20246 Klinikum Univ Regensburg /Id# 169963Regensburg, Germany, 93042 Universitatsklinikum Tubingen /Id# 169965Tuebingen, Germany, 72076|Amsterdam, Netherlands, 1081 Hv Mc Haaglanden /Id# 170150Leidschendam, Netherlands, 2262 Ba Umc Utrecht /Id# 170149Utrecht, Netherlands, 3584 Cx|Birmingham, United Kingdom, B15 2Th Castle Hill Hospital /Id# 200662Cottingham, United Kingdom, Hu16 5Jq Western General Hospital /Id# 203040Edinburgh, United Kingdom, Eh4 2Xu St. James University Hospital /Id# 200651Leeds, United Kingdom, Ls9 7Tf Freeman Hospital /Id# 200653Newcastle Upon Tyne, United Kingdom, Ne7 7Dn|Los Angeles, California, United States, 90033|Tampa, Florida, United States, 33612|Chicago, Illinois, United States, 60611 Rush University Medical Center /Id# 171003Chicago, Illinois, United States, 60612 Northshore Univ Healthsystem /Id# 164221Evanston, Illinois, United States, 60201 Cdh-Delnor Health System /Id# 169909Warrenville, Illinois, United States, 60555|New York, New York, United States, 10032-3725|Charlotte, North Carolina, United States, 28204 Duke Univ Med Ctr /Id# 170004Durham, North Carolina, United States, 27710|Houston, Texas, United States, 77030 Scott & White Mem Hosp & Clin /Id# 170792Temple, Texas, United States, 76508","California|Florida|Illinois|New York|North Carolina|Texas","Australia|Denmark|Germany|Netherlands|United Kingdom|United States","New South Wales Royal North Shore Hospital /Id# 169673|Queensland Royal Brisbane And Women's Hospital /Id# 169674|Victoria Austin Hospital /Id# 169671|Hovedstaden Rigshospitalet /Id# 170636|Nordjylland Aalborg University Hospital /Id# 168856|Baden-Wuerttemberg Universitaetsklinik Heidelberg /Id# 169970|Sachsen Universitaetsklinikum Leipzig /Id# 169969|Univ Klinik Eppendorf Hamburg /Id# 169971|Vrije Univ Medisch Centrum /Id# 170152|Queen Elizabeth Hospital - Birmingham /Id# 200657|Usc /Id# 164235|Moffitt Cancer Center /Id# 164234|Northwestern Medical /Id# 164231|Columbia Univ Medical Center /Id# 164220|Levine Cancer Ins, Carolina Me /Id# 171271|Ut Health Science Ctr-Houston /Id# 164223",{"$nulls":3},"AbbVie Inc.","2018-08-03","2020-05-25T16:40:02.742","2020-05-26T17:10:42.972","NCT03419403"]
["5ecbf4e2feab101b15530a2a","NCT03419403","2018-09-24","AbbVie","ABBV","Recruiting","A Study for Management of Ocular Side Effects in Subjects With Glioblastoma Receiving Depatuxizumab Mafodotin","Temozolomide|Vorsetuzumab mafodotin|Epinephrine","DNA Mtase Inhibitor|Tubulin Inhibitor|Mitosis Inhibitor|ADRB Agonist","Yes","['Vorsetuzumab mafodotin']","Unknown",null,"Phase 3",3,90,"Anticipated","2018-07-19","2019-09-16",{"$nulls":5},"This study will evaluate the effect of several ophthalmologic prophylactic treatment strategies for the management of ocular side effects (OSEs) in participants with epidermal growth factor receptor (EGFR)-amplified glioblastoma (GBM) who are being treated with depatuxizumab mafodotin (ABT-414). The study will include 2 phases during the treatment period: chemoradiation therapy (radiation plus temozolomide [RT/TMZ]) and adjuvant therapy (TMZ ). All participants will receive depatuxizumab mafodotin during both phases of the treatment period plus 1 of 3 prophylactic ophthalmologic treatments (standard steroids [SS], standard steroids with vasoconstrictors and cold compress [SS/VC], and enhanced steroids with vasoconstrictors and cooling compress [ES/VC]).",null,"Phase 3b Study for Management of Ocular Side Effects in Subjects With EGFR-amplified Glioblastoma Receiving Depatuxizumab Mafodotin (ABT-414)","M16-534","Glioblastoma Multiforme","Glioblastoma","Oncology Solid Tumor","Oncology","Experimental","Arm B: Standard Steroids + Vasoconstrictor + Cold Compress|Arm A: Standard Steroid (SS)|Arm C: Enhanced Steroids+Vasoconstrictor+Cold Compress (ES/VC)","Arm B: Steroid eye drop plus vasoconstrictor eye drop and cold compress plus depatuxizumab mafodotin during both the chemoradiation therapy (RT and TMZ) and the adjuvant therapy [TMZ] periods of this study.|Arm A: Steroid Eye Drops plus depatuxizumab mafodotin during both the chemoradiation therapy (radiation [RT] and temozolomide [TMZ]) and the adjuvant therapy [TMZ] periods of this study.|Arm C: Steroid Eye Drop plus ophthalmic steroid ointment plus vasoconstrictor eye drop and cold compresses plus depatuxizumab mafodotin during both the chemoradiation therapy (RT and TMZ) and the adjuvant therapy [TMZ] periods of this study.","Drug","Steroid eye drop|Radiation: Radiation|Temozolomide|depatuxizumab mafodotin|Vasoconstrictor eye drop|Ophthalmic steroid ointment","solution, eye drop|radiation|oral|infusion|ointment","ABT-414\ncold compresscold compress|ABT-414","Arm B: Standard Steroids + Vasoconstrictor + Cold Compress|Arm A: Standard Steroid (SS)|Arm C: Enhanced Steroids+Vasoconstrictor+Cold Compress (ES/VC)","\n\n * Newly diagnosed glioblastoma (GBM) histologically proven, World Health Organization (WHO) grade IV GBM or WHO grade IV gliosarcoma.\n * Tumors must demonstrate epidermal growth factor receptor (EGFR) amplification.\n * Tumors must be supratentorial in location.\n * Participant must have recovered from the effects of surgery, postoperative infection, and other complications; has no significant post-operative hemorrhage.\n * Participant has a Karnofsky performance status (KPS) of 70 or higher.\n * Participant has adequate bone marrow, renal, and hepatic function.\n * Electrocardiogram without evidence of acute cardiac ischemia <= 21 days prior to randomization.\n * Participant has a life expectancy of >= 3 months.\n\n","\n\n * Participants with newly diagnosed GBM: has received prior chemotherapy or radiotherapy for cancer of the head and neck region; has received prior treatment with Gliadel wafers or any other intratumoral or intracavitary treatment.\n * Participant has hypersensitivity to any component of TMZ or dacarbazine.\n * Participant has received anti-cancer therapy (including chemotherapy, immunotherapy, radiotherapy, hormonal, biologic, or any investigational therapy) prior to Study Day 1.\n * Participant has clinically significant uncontrolled condition(s) as described in the protocol.\n * Participant has any medical condition which in the opinion of the investigator places the participant at an unacceptably high risk for toxicities.\n * Participant has had another active malignancy within the past 3 years except for any cancer considered cured or non-melanoma carcinoma of the skin.\n * Participant has a history of herpetic keratitis.\n * Participant is not suitable for receiving ocular steroids with conditions as described in the protocol.\n * Participant has had laser-assisted in situ keratomileusis (LASIK) procedure within the last 1 year or cataract surgery within the last 3 months.\n * Participant has a visual condition that compromises the ability to accurately measure visual acuity or assess visual activities of daily living (vADLs).","EGFR","epidermal growth factor receptor","Protein","Ovary, Breast, Lung","Actual","2018-02-05","Actual","Anticipated","2019-11-21","Anticipated","2018-09-01","2018-01-26","2018-01-26","2018-09-21","No","Glioblastoma Multiforme (GBM)\ncancer\nchemoradiation therapy\nepidermal growth factor receptor-amplified glioblastoma\nradiation\ntemozolomide","Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No","Yes\nAbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2017-003171-64","EudraCT Number","Participants who Require a Change in Ocular Side Effect (OSE) Management","Ocular Side Effect (OSE) management is defined as a participant with >= 3-line loss (+ 0.3 on LogMAR scale or equivalent) of best corrected visual acuity from baseline (with prescription at baseline for those using corrective lens), or >= Grade 3 OSE severity on the Corneal Epithelial Adverse Event","CEAE scale.","Cumulative Dose of Depatuxizumab Mafodotin|Change from Baseline In Logarithm of the Minimum Angle of Resolution (LogMAR) Scale after Bandage Contact Lenses (BCL) Intervention|Time to OSE Symptom Resolution after Drug Discontinuation (reversibility)|Time to BCL Intervention|Participants that recover to <3-line decline from Baseline (<= +0.3 LogMAR) in visual acuity after BCL Intervention|Corneal Epithelial Adverse Event (CEAE) Grade|Time to Re-initiation of Depatuxizumab Mafodotin after Dose Interruption|Participants with Depatuxizumab Mafodotin Dose Interruptions due to OSEs|Participants with Depatuxizumab Mafodotin Dose Reductions due to OSEs|Maximum Change from Baseline on LogMAR Scale","Cumulative dose of depatuxizumab mafodotin administered (mg/kg).|Change on LogMAR Scale from last assessment prior to BCL intervention to 2 weeks after BCL intervention. The LogMAR scale measures visual acuity on a continuous scale, with a LogMAR value of 0 equivalent to 20/20 visual acuity. Normal vision is considered to be from -0.2 - 0.1; higher values indicate visual impairment.|Time from discontinuation of depatuxizumab mafodotin to OSE symptom resolution (reversibility).|Time to initiation of bandage contact lenses (BCL) intervention.|Recovery is defined as return to <3-line decline from baseline (<= +0.3 LogMAR) in visual acuity after BCL intervention.|The corneal epithelial adverse event (CEAE) rating scale is designed to record symptoms associated with corneal epitheliopathy caused by antibody-drug conjugates and to grade the severity of findings. The overall CEAE grade is measured on a scale of 0 to 5, with higher values being more severe, reflecting the impact of corneal abnormalities on visual activities of daily living (ADLs). Additional detailed information is collected for specific domains that are commonly affected, with the following ranges (each in order of increasing severity): ocular discomfort (0 - 4), photophobia (0 - 3), and reading (1 - 3).|Time from dose interruption until re-initiation or permanent discontinuation of depatuxizumab mafodotin.|Participants with dose interruptions of depatuxizumab mafodotin due to ocular side effects (OSEs).|Dose reductions of depatuxizumab mafodotin initiated due to OSEs.|The Logarithm of the Minimum Angle of Resolution (LogMAR) scale measures visual acuity on a continuous scale, with a LogMAR value of 0 equivalent to 20/20 visual acuity. Normal vision is considered to be from -0.2 - 0.1; higher values indicate visual impairment.","Up to approximately 18 weeks after initial dose of depatuxizumab mafodotin|Up to approximately 3 years after initial dose of depatuxizumab mafodotin","abbvieclinicaltrials@abbvie.com","ABBVIE CALL CENTER","847.283.8955","Saint Leonards, New South Wales, Australia, 2065 Calvary Mater Newcastle /Id# 169672Waratah, New South Wales, Australia, 2298|Herston, Queensland, Australia, 4029|Heidelberg, Victoria, Australia, 3084|Copenhagen Ã˜, Hovedstaden, Denmark, 2100|Aalborg, Nordjylland, Denmark, 9000|Heidelberg, Baden-Wuerttemberg, Germany, 69120|Leipzig, Sachsen, Germany, 04103|Hamburg, Germany, 20246 Klinikum Univ Regensburg /Id# 169963Regensburg, Germany, 93042 Universitatsklinikum Tubingen /Id# 169965Tuebingen, Germany, 72076|Amsterdam, Netherlands, 1081 Hv Umc Utrecht /Id# 170149Utrecht, Netherlands, 3584 Cx|Birmingham, United Kingdom, B15 2Th Castle Hill Hospital /Id# 200662Cottingham, United Kingdom, Hu16 5Jq Western General Hospital /Id# 203040Edinburgh, United Kingdom, Eh4 2Xu Freeman Hospital /Id# 200653Newcastle Upon Tyne, United Kingdom, Ne7 7Dn|Los Angeles, California, United States, 90033|Tampa, Florida, United States, 33612|Chicago, Illinois, United States, 60611 Rush University Medical Center /Id# 171003Chicago, Illinois, United States, 60612 Northshore Univ Healthsystem /Id# 164221Evanston, Illinois, United States, 60201 Cdh-Delnor Health System /Id# 169909Warrenville, Illinois, United States, 60555|New York, New York, United States, 10032-3725|Charlotte, North Carolina, United States, 28204 Duke Univ Med Ctr /Id# 170004Durham, North Carolina, United States, 27710|Houston, Texas, United States, 77030 Scott & White Mem Hosp & Clin /Id# 170792Temple, Texas, United States, 76508","California|Florida|Illinois|New York|North Carolina|Texas","Australia|Denmark|Germany|Netherlands|United Kingdom|United States","New South Wales Royal North Shore Hospital /Id# 169673|Queensland Royal Brisbane And Women's Hospital /Id# 169674|Victoria Austin Hospital /Id# 169671|Hovedstaden Rigshospitalet /Id# 170636|Nordjylland Aalborg University Hospital /Id# 168856|Baden-Wuerttemberg Universitaetsklinik Heidelberg /Id# 169970|Sachsen Universitaetsklinikum Leipzig /Id# 169969|Univ Klinik Eppendorf Hamburg /Id# 169971|Vrije Univ Medisch Centrum /Id# 170152|Queen Elizabeth Hospital - Birmingham /Id# 200657|Usc /Id# 164235|Moffitt Cancer Center /Id# 164234|Northwestern Medical /Id# 164231|Columbia Univ Medical Center /Id# 164220|Levine Cancer Ins, Carolina Me /Id# 171271|Ut Health Science Ctr-Houston /Id# 164223",{"$nulls":3},"AbbVie Inc.","2018-09-21","2020-05-25T16:40:02.795","2020-05-26T17:10:42.972","NCT03419403"]
["5ecbf4e2e2561b1b11905ef6","NCT03419403","2018-11-02","AbbVie","ABBV","Recruiting","A Study for Management of Ocular Side Effects in Subjects With Glioblastoma Receiving Depatuxizumab Mafodotin","Temozolomide|Vorsetuzumab mafodotin|Epinephrine","DNA Mtase Inhibitor|Tubulin Inhibitor|Mitosis Inhibitor|ADRB Agonist","Yes","['Vorsetuzumab mafodotin']","Unknown",null,"Phase 3",3,90,"Anticipated","2018-07-19","2019-09-16",{"$nulls":5},"This study will evaluate the effect of several ophthalmologic prophylactic treatment strategies for the management of ocular side effects (OSEs) in participants with epidermal growth factor receptor (EGFR)-amplified glioblastoma (GBM) who are being treated with depatuxizumab mafodotin (ABT-414). The study will include 2 phases during the treatment period: chemoradiation therapy (radiation plus temozolomide [RT/TMZ]) and adjuvant therapy (TMZ ). All participants will receive depatuxizumab mafodotin during both phases of the treatment period plus 1 of 3 prophylactic ophthalmologic treatments (standard steroids [SS], standard steroids with vasoconstrictors and cold compress [SS/VC], and enhanced steroids with vasoconstrictors and cooling compress [ES/VC]).",null,"Phase 3b Study for Management of Ocular Side Effects in Subjects With EGFR-amplified Glioblastoma Receiving Depatuxizumab Mafodotin (ABT-414)","M16-534","Glioblastoma Multiforme","Glioblastoma","Oncology Solid Tumor","Oncology","Experimental","Arm B: Standard Steroids + Vasoconstrictor + Cold Compress|Arm A: Standard Steroid (SS)|Arm C: Enhanced Steroids+Vasoconstrictor+Cold Compress (ES/VC)","Arm B: Steroid eye drop plus vasoconstrictor eye drop and cold compress plus depatuxizumab mafodotin during both the chemoradiation therapy (RT and TMZ) and the adjuvant therapy [TMZ] periods of this study.|Arm A: Steroid Eye Drops plus depatuxizumab mafodotin during both the chemoradiation therapy (radiation [RT] and temozolomide [TMZ]) and the adjuvant therapy [TMZ] periods of this study.|Arm C: Steroid Eye Drop plus ophthalmic steroid ointment plus vasoconstrictor eye drop and cold compresses plus depatuxizumab mafodotin during both the chemoradiation therapy (RT and TMZ) and the adjuvant therapy [TMZ] periods of this study.","Drug","Steroid eye drop|Radiation: Radiation|Temozolomide|depatuxizumab mafodotin|Vasoconstrictor eye drop|Ophthalmic steroid ointment","solution, eye drop|radiation|oral|infusion|ointment","ABT-414\ncold compresscold compress|ABT-414","Arm B: Standard Steroids + Vasoconstrictor + Cold Compress|Arm A: Standard Steroid (SS)|Arm C: Enhanced Steroids+Vasoconstrictor+Cold Compress (ES/VC)","\n\n * Newly diagnosed glioblastoma (GBM) histologically proven, World Health Organization (WHO) grade IV GBM or WHO grade IV gliosarcoma.\n * Tumors must demonstrate epidermal growth factor receptor (EGFR) amplification.\n * Tumors must be supratentorial in location.\n * Participant must have recovered from the effects of surgery, postoperative infection, and other complications; has no significant post-operative hemorrhage.\n * Participant has a Karnofsky performance status (KPS) of 70 or higher.\n * Participant has adequate bone marrow, renal, and hepatic function.\n * Electrocardiogram without evidence of acute cardiac ischemia <= 21 days prior to randomization.\n * Participant has a life expectancy of >= 3 months.\n\n","\n\n * Participants with newly diagnosed GBM: has received prior chemotherapy or radiotherapy for cancer of the head and neck region; has received prior treatment with Gliadel wafers or any other intratumoral or intracavitary treatment.\n * Participant has hypersensitivity to any component of TMZ or dacarbazine.\n * Participant has received anti-cancer therapy (including chemotherapy, immunotherapy, radiotherapy, hormonal, biologic, or any investigational therapy) prior to Study Day 1.\n * Participant has clinically significant uncontrolled condition(s) as described in the protocol.\n * Participant has any medical condition which in the opinion of the investigator places the participant at an unacceptably high risk for toxicities.\n * Participant has had another active malignancy within the past 3 years except for any cancer considered cured or non-melanoma carcinoma of the skin.\n * Participant has a history of herpetic keratitis.\n * Participant is not suitable for receiving ocular steroids with conditions as described in the protocol.\n * Participant has had laser-assisted in situ keratomileusis (LASIK) procedure within the last 1 year or cataract surgery within the last 3 months.\n * Participant has a visual condition that compromises the ability to accurately measure visual acuity or assess visual activities of daily living (vADLs).","EGFR","epidermal growth factor receptor","Protein","Ovary, Breast, Lung","Actual","2018-02-05","Actual","Anticipated","2019-11-21","Anticipated","2018-10-01","2018-01-26","2018-01-26","2018-11-01","No","Glioblastoma Multiforme (GBM)\ncancer\nchemoradiation therapy\nepidermal growth factor receptor-amplified glioblastoma\nradiation\ntemozolomide","Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No","Yes\nAbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2017-003171-64","EudraCT Number","Participants who Require a Change in Ocular Side Effect (OSE) Management","Ocular Side Effect (OSE) management is defined as a participant with >= 3-line loss (+ 0.3 on LogMAR scale or equivalent) of best corrected visual acuity from baseline (with prescription at baseline for those using corrective lens), or >= Grade 3 OSE severity on the Corneal Epithelial Adverse Event","CEAE scale.","Cumulative Dose of Depatuxizumab Mafodotin|Change from Baseline In Logarithm of the Minimum Angle of Resolution (LogMAR) Scale after Bandage Contact Lenses (BCL) Intervention|Time to OSE Symptom Resolution after Drug Discontinuation (reversibility)|Time to BCL Intervention|Participants that recover to <3-line decline from Baseline (<= +0.3 LogMAR) in visual acuity after BCL Intervention|Corneal Epithelial Adverse Event (CEAE) Grade|Time to Re-initiation of Depatuxizumab Mafodotin after Dose Interruption|Participants with Depatuxizumab Mafodotin Dose Interruptions due to OSEs|Participants with Depatuxizumab Mafodotin Dose Reductions due to OSEs|Maximum Change from Baseline on LogMAR Scale","Cumulative dose of depatuxizumab mafodotin administered (mg/kg).|Change on LogMAR Scale from last assessment prior to BCL intervention to 2 weeks after BCL intervention. The LogMAR scale measures visual acuity on a continuous scale, with a LogMAR value of 0 equivalent to 20/20 visual acuity. Normal vision is considered to be from -0.2 - 0.1; higher values indicate visual impairment.|Time from discontinuation of depatuxizumab mafodotin to OSE symptom resolution (reversibility).|Time to initiation of bandage contact lenses (BCL) intervention.|Recovery is defined as return to <3-line decline from baseline (<= +0.3 LogMAR) in visual acuity after BCL intervention.|The corneal epithelial adverse event (CEAE) rating scale is designed to record symptoms associated with corneal epitheliopathy caused by antibody-drug conjugates and to grade the severity of findings. The overall CEAE grade is measured on a scale of 0 to 5, with higher values being more severe, reflecting the impact of corneal abnormalities on visual activities of daily living (ADLs). Additional detailed information is collected for specific domains that are commonly affected, with the following ranges (each in order of increasing severity): ocular discomfort (0 - 4), photophobia (0 - 3), and reading (1 - 3).|Time from dose interruption until re-initiation or permanent discontinuation of depatuxizumab mafodotin.|Participants with dose interruptions of depatuxizumab mafodotin due to ocular side effects (OSEs).|Dose reductions of depatuxizumab mafodotin initiated due to OSEs.|The Logarithm of the Minimum Angle of Resolution (LogMAR) scale measures visual acuity on a continuous scale, with a LogMAR value of 0 equivalent to 20/20 visual acuity. Normal vision is considered to be from -0.2 - 0.1; higher values indicate visual impairment.","Up to approximately 18 weeks after initial dose of depatuxizumab mafodotin|Up to approximately 3 years after initial dose of depatuxizumab mafodotin","abbvieclinicaltrials@abbvie.com","ABBVIE CALL CENTER","847.283.8955","Saint Leonards, New South Wales, Australia, 2065 Calvary Mater Newcastle /Id# 169672Waratah, New South Wales, Australia, 2298|Herston, Queensland, Australia, 4029|Heidelberg, Victoria, Australia, 3084|Copenhagen Ã˜, Hovedstaden, Denmark, 2100|Aalborg, Nordjylland, Denmark, 9000|Heidelberg, Baden-Wuerttemberg, Germany, 69120|Leipzig, Sachsen, Germany, 04103|Hamburg, Germany, 20246 Klinikum Univ Regensburg /Id# 169963Regensburg, Germany, 93042 Universitatsklinikum Tubingen /Id# 169965Tuebingen, Germany, 72076|Amsterdam, Netherlands, 1081 Hv Medisch Spectrum Twente /Id# 201603Enschede, Netherlands, 7511 Jx Universitair Medisch Centrum Utrecht /Id# 170149Utrecht, Netherlands, 3584 Cx|Birmingham, United Kingdom, B15 2Th Castle Hill Hospital /Id# 200662Cottingham, United Kingdom, Hu16 5Jq Western General Hospital /Id# 203040Edinburgh, United Kingdom, Eh4 2Xu Freeman Hospital /Id# 200653Newcastle Upon Tyne, United Kingdom, Ne7 7Dn|Los Angeles, California, United States, 90033|Tampa, Florida, United States, 33612|Chicago, Illinois, United States, 60611 Rush University Medical Center /Id# 171003Chicago, Illinois, United States, 60612 Northshore Univ Healthsystem /Id# 164221Evanston, Illinois, United States, 60201 Cdh-Delnor Health System /Id# 169909Warrenville, Illinois, United States, 60555|New York, New York, United States, 10032-3725|Charlotte, North Carolina, United States, 28204 Duke Univ Med Ctr /Id# 170004Durham, North Carolina, United States, 27710|Houston, Texas, United States, 77030 Scott & White Mem Hosp & Clin /Id# 170792Temple, Texas, United States, 76508","California|Florida|Illinois|New York|North Carolina|Texas","Australia|Denmark|Germany|Netherlands|United Kingdom|United States","New South Wales Royal North Shore Hospital /Id# 169673|Queensland Royal Brisbane And Women's Hospital /Id# 169674|Victoria Austin Hospital /Id# 169671|Hovedstaden Rigshospitalet /Id# 170636|Nordjylland Aalborg University Hospital /Id# 168856|Baden-Wuerttemberg Universitaetsklinik Heidelberg /Id# 169970|Sachsen Universitaetsklinikum Leipzig /Id# 169969|Univ Klinik Eppendorf Hamburg /Id# 169971|Vrije Universiteit Medisch Centrum /Id# 170152|Queen Elizabeth Hospital - Birmingham /Id# 200657|Usc /Id# 164235|Moffitt Cancer Center /Id# 164234|Northwestern Medical /Id# 164231|Columbia Univ Medical Center /Id# 164220|Levine Cancer Ins, Carolina Me /Id# 171271|Ut Health Science Ctr-Houston /Id# 164223",{"$nulls":3},"AbbVie Inc.","2018-11-01","2020-05-25T16:40:02.820","2020-05-26T17:10:42.972","NCT03419403"]
["5ecbf4e2fe30261b1a0483fc","NCT03419403","2018-12-13","AbbVie","ABBV","Recruiting","A Study for Management of Ocular Side Effects in Subjects With Glioblastoma Receiving Depatuxizumab Mafodotin","Temozolomide|Vorsetuzumab mafodotin|Epinephrine","DNA Mtase Inhibitor|Tubulin Inhibitor|Mitosis Inhibitor|ADRB Agonist","Yes","['Vorsetuzumab mafodotin']","Unknown",null,"Phase 3",3,90,"Anticipated","2018-07-30","2019-09-16",{"$nulls":5},"This study will evaluate the effect of several ophthalmologic prophylactic treatment strategies for the management of ocular side effects (OSEs) in participants with epidermal growth factor receptor (EGFR)-amplified glioblastoma (GBM) who are being treated with depatuxizumab mafodotin (ABT-414). The study will include 2 phases during the treatment period: chemoradiation therapy (radiation plus temozolomide [RT/TMZ]) and adjuvant therapy (TMZ ). All participants will receive depatuxizumab mafodotin during both phases of the treatment period plus 1 of 3 prophylactic ophthalmologic treatments (standard steroids [SS], standard steroids with vasoconstrictors and cold compress [SS/VC], and enhanced steroids with vasoconstrictors and cooling compress [ES/VC]).",null,"Phase 3b Study for Management of Ocular Side Effects in Subjects With EGFR-amplified Glioblastoma Receiving Depatuxizumab Mafodotin (ABT-414)","M16-534","Glioblastoma Multiforme","Glioblastoma","Oncology Solid Tumor","Oncology","Experimental","Arm B: Standard Steroids + Vasoconstrictor + Cold Compress|Arm A: Standard Steroid (SS)|Arm C: Enhanced Steroids+Vasoconstrictor+Cold Compress (ES/VC)","Arm B: Steroid eye drop plus vasoconstrictor eye drop and cold compress plus depatuxizumab mafodotin during both the chemoradiation therapy (RT and TMZ) and the adjuvant therapy [TMZ] periods of this study.|Arm A: Steroid Eye Drops plus depatuxizumab mafodotin during both the chemoradiation therapy (radiation [RT] and temozolomide [TMZ]) and the adjuvant therapy [TMZ] periods of this study.|Arm C: Steroid Eye Drop plus ophthalmic steroid ointment plus vasoconstrictor eye drop and cold compresses plus depatuxizumab mafodotin during both the chemoradiation therapy (RT and TMZ) and the adjuvant therapy [TMZ] periods of this study.","Drug","Steroid eye drop|Radiation: Radiation|Temozolomide|depatuxizumab mafodotin|Vasoconstrictor eye drop|Ophthalmic steroid ointment","solution, eye drop|radiation|oral|infusion|ointment","ABT-414\ncold compresscold compress|ABT-414","Arm B: Standard Steroids + Vasoconstrictor + Cold Compress|Arm A: Standard Steroid (SS)|Arm C: Enhanced Steroids+Vasoconstrictor+Cold Compress (ES/VC)","\n\n * Newly diagnosed glioblastoma (GBM) histologically proven, World Health Organization (WHO) grade IV GBM or WHO grade IV gliosarcoma.\n * Tumors must demonstrate epidermal growth factor receptor (EGFR) amplification.\n * Tumors must be supratentorial in location.\n * Participant must have recovered from the effects of surgery, postoperative infection, and other complications; has no significant post-operative hemorrhage.\n * Participant has a Karnofsky performance status (KPS) of 70 or higher.\n * Participant has adequate bone marrow, renal, and hepatic function.\n * Electrocardiogram without evidence of acute cardiac ischemia <= 21 days prior to randomization.\n * Participant has a life expectancy of >= 3 months.\n\n","\n\n * Participants with newly diagnosed GBM: has received prior chemotherapy or radiotherapy for cancer of the head and neck region; has received prior treatment with Gliadel wafers or any other intratumoral or intracavitary treatment.\n * Participant has hypersensitivity to any component of TMZ or dacarbazine.\n * Participant has received anti-cancer therapy (including chemotherapy, immunotherapy, radiotherapy, hormonal, biologic, or any investigational therapy) prior to Study Day 1.\n * Participant has clinically significant uncontrolled condition(s) as described in the protocol.\n * Participant has any medical condition which in the opinion of the investigator places the participant at an unacceptably high risk for toxicities.\n * Participant has had another active malignancy within the past 3 years except for any cancer considered cured or non-melanoma carcinoma of the skin.\n * Participant has a history of herpetic keratitis.\n * Participant is not suitable for receiving ocular steroids with conditions as described in the protocol.\n * Participant has had laser-assisted in situ keratomileusis (LASIK) procedure within the last 1 year or cataract surgery within the last 3 months.\n * Participant has a visual condition that compromises the ability to accurately measure visual acuity or assess visual activities of daily living (vADLs).","EGFR","epidermal growth factor receptor","Protein","Ovary, Breast, Lung","Actual","2018-02-05","Actual","Anticipated","2020-03-08","Anticipated","2018-12-01","2018-01-26","2018-01-26","2018-12-11","No","Glioblastoma Multiforme (GBM)\ncancer\nchemoradiation therapy\nepidermal growth factor receptor-amplified glioblastoma\nradiation\ntemozolomide","Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No","Yes\nAbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2017-003171-64","EudraCT Number","Participants who Require a Change in Ocular Side Effect (OSE) Management","Ocular Side Effect (OSE) management is defined as a participant with >= 3-line loss (+ 0.3 on LogMAR scale or equivalent) of best corrected visual acuity from baseline (with prescription at baseline for those using corrective lens), or >= Grade 3 OSE severity on the Corneal Epithelial Adverse Event","CEAE scale.","Cumulative Dose of Depatuxizumab Mafodotin|Change from Baseline In Logarithm of the Minimum Angle of Resolution (LogMAR) Scale after Bandage Contact Lenses (BCL) Intervention|Time to OSE Symptom Resolution after Drug Discontinuation (reversibility)|Time to BCL Intervention|Participants that recover to <3-line decline from Baseline (<= +0.3 LogMAR) in visual acuity after BCL Intervention|Corneal Epithelial Adverse Event (CEAE) Grade|Time to Re-initiation of Depatuxizumab Mafodotin after Dose Interruption|Participants with Depatuxizumab Mafodotin Dose Interruptions due to OSEs|Participants with Depatuxizumab Mafodotin Dose Reductions due to OSEs|Maximum Change from Baseline on LogMAR Scale","Cumulative dose of depatuxizumab mafodotin administered (mg/kg).|Change on LogMAR Scale from last assessment prior to BCL intervention to 2 weeks after BCL intervention. The LogMAR scale measures visual acuity on a continuous scale, with a LogMAR value of 0 equivalent to 20/20 visual acuity. Normal vision is considered to be from -0.2 - 0.1; higher values indicate visual impairment.|Time from discontinuation of depatuxizumab mafodotin to OSE symptom resolution (reversibility).|Time to initiation of bandage contact lenses (BCL) intervention.|Recovery is defined as return to <3-line decline from baseline (<= +0.3 LogMAR) in visual acuity after BCL intervention.|The corneal epithelial adverse event (CEAE) rating scale is designed to record symptoms associated with corneal epitheliopathy caused by antibody-drug conjugates and to grade the severity of findings. The overall CEAE grade is measured on a scale of 0 to 5, with higher values being more severe, reflecting the impact of corneal abnormalities on visual activities of daily living (ADLs). Additional detailed information is collected for specific domains that are commonly affected, with the following ranges (each in order of increasing severity): ocular discomfort (0 - 4), photophobia (0 - 3), and reading (1 - 3).|Time from dose interruption until re-initiation or permanent discontinuation of depatuxizumab mafodotin.|Participants with dose interruptions of depatuxizumab mafodotin due to ocular side effects (OSEs).|Dose reductions of depatuxizumab mafodotin initiated due to OSEs.|The Logarithm of the Minimum Angle of Resolution (LogMAR) scale measures visual acuity on a continuous scale, with a LogMAR value of 0 equivalent to 20/20 visual acuity. Normal vision is considered to be from -0.2 - 0.1; higher values indicate visual impairment.","Up to approximately 18 weeks after initial dose of depatuxizumab mafodotin|Up to approximately 3 years after initial dose of depatuxizumab mafodotin","abbvieclinicaltrials@abbvie.com","ABBVIE CALL CENTER","847.283.8955","Saint Leonards, New South Wales, Australia, 2065 Calvary Mater Newcastle /Id# 169672Waratah, New South Wales, Australia, 2298|Herston, Queensland, Australia, 4029|Heidelberg, Victoria, Australia, 3084|Heidelberg, Baden-Wuerttemberg, Germany, 69120|Leipzig, Sachsen, Germany, 04103|Hamburg, Germany, 20246 Klinikum Univ Regensburg /Id# 169963Regensburg, Germany, 93042 Universitatsklinikum Tubingen /Id# 169965Tuebingen, Germany, 72076|Amsterdam, Netherlands, 1081 Hv Medisch Spectrum Twente /Id# 201603Enschede, Netherlands, 7511 Jx Universitair Medisch Centrum Utrecht /Id# 170149Utrecht, Netherlands, 3584 Cx|Birmingham, United Kingdom, B15 2Th Castle Hill Hospital /Id# 200662Cottingham, United Kingdom, Hu16 5Jq Western General Hospital /Id# 203040Edinburgh, United Kingdom, Eh4 2Xu Freeman Hospital /Id# 200653Newcastle Upon Tyne, United Kingdom, Ne7 7Dn|Los Angeles, California, United States, 90033|Tampa, Florida, United States, 33612|Chicago, Illinois, United States, 60611 Rush University Medical Center /Id# 171003Chicago, Illinois, United States, 60612 Northshore Univ Healthsystem /Id# 164221Evanston, Illinois, United States, 60201 Cdh-Delnor Health System /Id# 169909Warrenville, Illinois, United States, 60555|New York, New York, United States, 10032-3725|Charlotte, North Carolina, United States, 28204 Duke Univ Med Ctr /Id# 170004Durham, North Carolina, United States, 27710|Houston, Texas, United States, 77030 Scott & White Mem Hosp & Clin /Id# 170792Temple, Texas, United States, 76508","California|Florida|Illinois|New York|North Carolina|Texas","Australia|Germany|Netherlands|United Kingdom|United States","New South Wales Royal North Shore Hospital /Id# 169673|Queensland Royal Brisbane And Women's Hospital /Id# 169674|Victoria Austin Hospital /Id# 169671|Baden-Wuerttemberg Universitaetsklinik Heidelberg /Id# 169970|Sachsen Universitaetsklinikum Leipzig /Id# 169969|Univ Klinik Eppendorf Hamburg /Id# 169971|Vrije Universiteit Medisch Centrum /Id# 170152|Queen Elizabeth Hospital - Birmingham /Id# 200657|Usc /Id# 164235|Moffitt Cancer Center /Id# 164234|Northwestern Medical /Id# 164231|Columbia Univ Medical Center /Id# 164220|Levine Cancer Ins, Carolina Me /Id# 171271|Ut Health Science Ctr-Houston /Id# 164223",{"$nulls":3},"AbbVie Inc.","2018-12-11","2020-05-25T16:40:02.894","2020-05-26T17:10:42.972","NCT03419403"]
["5ecbf4e2307e3d1b1f8d9e8d","NCT03419403","2019-01-08","AbbVie","ABBV","Recruiting","A Study for Management of Ocular Side Effects in Subjects With Glioblastoma Receiving Depatuxizumab Mafodotin","Temozolomide|Vorsetuzumab mafodotin|Epinephrine","DNA Mtase Inhibitor|Tubulin Inhibitor|Mitosis Inhibitor|ADRB Agonist","Yes","['Vorsetuzumab mafodotin']","Unknown",null,"Phase 3",3,90,"Anticipated","2018-07-30","2019-09-16",{"$nulls":5},"This study will evaluate the effect of several ophthalmologic prophylactic treatment strategies for the management of ocular side effects (OSEs) in participants with epidermal growth factor receptor (EGFR)-amplified glioblastoma (GBM) who are being treated with depatuxizumab mafodotin (ABT-414). The study will include 2 phases during the treatment period: chemoradiation therapy (radiation plus temozolomide [RT/TMZ]) and adjuvant therapy (TMZ ). All participants will receive depatuxizumab mafodotin during both phases of the treatment period plus 1 of 3 prophylactic ophthalmologic treatments (standard steroids [SS], standard steroids with vasoconstrictors and cold compress [SS/VC], and enhanced steroids with vasoconstrictors and cooling compress [ES/VC]).",null,"Phase 3b Study for Management of Ocular Side Effects in Subjects With EGFR-amplified Glioblastoma Receiving Depatuxizumab Mafodotin (ABT-414)","M16-534","Glioblastoma Multiforme","Glioblastoma","Oncology Solid Tumor","Oncology","Experimental","Arm B: Standard Steroids + Vasoconstrictor + Cold Compress|Arm A: Standard Steroid (SS)|Arm C: Enhanced Steroids+Vasoconstrictor+Cold Compress (ES/VC)","Arm B: Steroid eye drop plus vasoconstrictor eye drop and cold compress plus depatuxizumab mafodotin during both the chemoradiation therapy (RT and TMZ) and the adjuvant therapy [TMZ] periods of this study.|Arm A: Steroid Eye Drops plus depatuxizumab mafodotin during both the chemoradiation therapy (radiation [RT] and temozolomide [TMZ]) and the adjuvant therapy [TMZ] periods of this study.|Arm C: Steroid Eye Drop plus ophthalmic steroid ointment plus vasoconstrictor eye drop and cold compresses plus depatuxizumab mafodotin during both the chemoradiation therapy (RT and TMZ) and the adjuvant therapy [TMZ] periods of this study.","Drug","Steroid eye drop|Radiation: Radiation|Temozolomide|depatuxizumab mafodotin|Vasoconstrictor eye drop|Ophthalmic steroid ointment","solution, eye drop|radiation|oral|infusion|ointment","ABT-414\ncold compresscold compress|ABT-414","Arm B: Standard Steroids + Vasoconstrictor + Cold Compress|Arm A: Standard Steroid (SS)|Arm C: Enhanced Steroids+Vasoconstrictor+Cold Compress (ES/VC)","\n\n * Newly diagnosed glioblastoma (GBM) histologically proven, World Health Organization (WHO) grade IV GBM or WHO grade IV gliosarcoma.\n * Tumors must demonstrate epidermal growth factor receptor (EGFR) amplification.\n * Tumors must be supratentorial in location.\n * Participant must have recovered from the effects of surgery, postoperative infection, and other complications; has no significant post-operative hemorrhage.\n * Participant has a Karnofsky performance status (KPS) of 70 or higher.\n * Participant has adequate bone marrow, renal, and hepatic function.\n * Electrocardiogram without evidence of acute cardiac ischemia <= 21 days prior to randomization.\n * Participant has a life expectancy of >= 3 months.\n\n","\n\n * Participants with newly diagnosed GBM: has received prior chemotherapy or radiotherapy for cancer of the head and neck region; has received prior treatment with Gliadel wafers or any other intratumoral or intracavitary treatment.\n * Participant has hypersensitivity to any component of TMZ or dacarbazine.\n * Participant has received anti-cancer therapy (including chemotherapy, immunotherapy, radiotherapy, hormonal, biologic, or any investigational therapy) within 5 years of Study Day 1.\n * Participant has clinically significant uncontrolled condition(s) as described in the protocol.\n * Participant has any medical condition which in the opinion of the investigator places the participant at an unacceptably high risk for toxicities.\n * Participant has had another active malignancy within the past 3 years except for any cancer considered cured or non-melanoma carcinoma of the skin.\n * Participant has a history of herpetic keratitis.\n * Participant is not suitable for receiving ocular steroids with conditions as described in the protocol.\n * Participant has had laser-assisted in situ keratomileusis (LASIK) procedure within the last 1 year or cataract surgery within the last 3 months.\n * Participant has a visual condition that compromises the ability to accurately measure visual acuity or assess visual activities of daily living (vADLs).\n * Participant has hepatitis B virus or hepatitis C virus infection.\n * Participant not receiving treatment with highly active antiretroviral therapy (HAART) when positive for human immunodeficiency virus (HIV).","EGFR","epidermal growth factor receptor","Protein","Ovary, Breast, Lung","Actual","2018-02-05","Actual","Anticipated","2020-03-08","Anticipated","2019-01-01","2018-01-26","2018-01-26","2019-01-07","No","Glioblastoma Multiforme (GBM)\ncancer\nchemoradiation therapy\nepidermal growth factor receptor-amplified glioblastoma\nradiation\ntemozolomide","Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No","Yes\nAbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2017-003171-64","EudraCT Number","Participants who Require a Change in Ocular Side Effect (OSE) Management","Ocular Side Effect (OSE) management is defined as a participant with >= 3-line loss (+ 0.3 on LogMAR scale or equivalent) of best corrected visual acuity from baseline (with prescription at baseline for those using corrective lens), or >= Grade 3 OSE severity on the Corneal Epithelial Adverse Event","CEAE scale.","Cumulative Dose of Depatuxizumab Mafodotin|Change from Baseline In Logarithm of the Minimum Angle of Resolution (LogMAR) Scale after Bandage Contact Lenses (BCL) Intervention|Time to OSE Symptom Resolution after Drug Discontinuation (reversibility)|Time to BCL Intervention|Participants that recover to <3-line decline from Baseline (<= +0.3 LogMAR) in visual acuity after BCL Intervention|Corneal Epithelial Adverse Event (CEAE) Grade|Time to Re-initiation of Depatuxizumab Mafodotin after Dose Interruption|Participants with Depatuxizumab Mafodotin Dose Interruptions due to OSEs|Participants with Depatuxizumab Mafodotin Dose Reductions due to OSEs|Maximum Change from Baseline on LogMAR Scale","Cumulative dose of depatuxizumab mafodotin administered (mg/kg).|Change on LogMAR Scale from last assessment prior to BCL intervention to 2 weeks after BCL intervention. The LogMAR scale measures visual acuity on a continuous scale, with a LogMAR value of 0 equivalent to 20/20 visual acuity. Normal vision is considered to be from -0.2 - 0.1; higher values indicate visual impairment.|Time from discontinuation of depatuxizumab mafodotin to OSE symptom resolution (reversibility).|Time to initiation of bandage contact lenses (BCL) intervention.|Recovery is defined as return to <3-line decline from baseline (<= +0.3 LogMAR) in visual acuity after BCL intervention.|The corneal epithelial adverse event (CEAE) rating scale is designed to record symptoms associated with corneal epitheliopathy caused by antibody-drug conjugates and to grade the severity of findings. The overall CEAE grade is measured on a scale of 0 to 5, with higher values being more severe, reflecting the impact of corneal abnormalities on visual activities of daily living (ADLs). Additional detailed information is collected for specific domains that are commonly affected, with the following ranges (each in order of increasing severity): ocular discomfort (0 - 4), photophobia (0 - 3), and reading (1 - 3).|Time from dose interruption until re-initiation or permanent discontinuation of depatuxizumab mafodotin.|Participants with dose interruptions of depatuxizumab mafodotin due to ocular side effects (OSEs).|Dose reductions of depatuxizumab mafodotin initiated due to OSEs.|The Logarithm of the Minimum Angle of Resolution (LogMAR) scale measures visual acuity on a continuous scale, with a LogMAR value of 0 equivalent to 20/20 visual acuity. Normal vision is considered to be from -0.2 - 0.1; higher values indicate visual impairment.","Up to approximately 18 weeks after initial dose of depatuxizumab mafodotin|Up to approximately 3 years after initial dose of depatuxizumab mafodotin","abbvieclinicaltrials@abbvie.com","ABBVIE CALL CENTER","847.283.8955","Saint Leonards, New South Wales, Australia, 2065 Calvary Mater Newcastle /Id# 169672Waratah, New South Wales, Australia, 2298|Herston, Queensland, Australia, 4029|Heidelberg, Victoria, Australia, 3084|Heidelberg, Baden-Wuerttemberg, Germany, 69120|Leipzig, Sachsen, Germany, 04103|Hamburg, Germany, 20246 Klinikum Univ Regensburg /Id# 169963Regensburg, Germany, 93042 Universitatsklinikum Tubingen /Id# 169965Tuebingen, Germany, 72076|Amsterdam, Netherlands, 1081 Hv Medisch Spectrum Twente /Id# 201603Enschede, Netherlands, 7511 Jx Universitair Medisch Centrum Utrecht /Id# 170149Utrecht, Netherlands, 3584 Cx|Birmingham, United Kingdom, B15 2Th Castle Hill Hospital /Id# 200662Cottingham, United Kingdom, Hu16 5Jq Western General Hospital /Id# 203040Edinburgh, United Kingdom, Eh4 2Xu Freeman Hospital /Id# 200653Newcastle Upon Tyne, United Kingdom, Ne7 7Dn|Los Angeles, California, United States, 90033|Tampa, Florida, United States, 33612|Chicago, Illinois, United States, 60611 Rush University Medical Center /Id# 171003Chicago, Illinois, United States, 60612 Northshore Univ Healthsystem /Id# 164221Evanston, Illinois, United States, 60201 Cdh-Delnor Health System /Id# 169909Warrenville, Illinois, United States, 60555|New York, New York, United States, 10032-3725|Charlotte, North Carolina, United States, 28204 Duke Univ Med Ctr /Id# 170004Durham, North Carolina, United States, 27710|Houston, Texas, United States, 77030 Scott & White Mem Hosp & Clin /Id# 170792Temple, Texas, United States, 76508","California|Florida|Illinois|New York|North Carolina|Texas","Australia|Germany|Netherlands|United Kingdom|United States","New South Wales Royal North Shore Hospital /Id# 169673|Queensland Royal Brisbane And Women's Hospital /Id# 169674|Victoria Austin Hospital /Id# 169671|Baden-Wuerttemberg Universitaetsklinik Heidelberg /Id# 169970|Sachsen Universitaetsklinikum Leipzig /Id# 169969|Univ Klinik Eppendorf Hamburg /Id# 169971|Vrije Universiteit Medisch Centrum /Id# 170152|Queen Elizabeth Hospital - Birmingham /Id# 200657|Usc /Id# 164235|Moffitt Cancer Center /Id# 164234|Northwestern Medical /Id# 164231|Columbia Univ Medical Center /Id# 164220|Levine Cancer Ins, Carolina Me /Id# 171271|Ut Health Science Ctr-Houston /Id# 164223",{"$nulls":3},"AbbVie Inc.","2019-01-07","2020-05-25T16:40:02.915","2020-05-26T17:10:42.972","NCT03419403"]
["5ecbf4e211702c1b1b916c08","NCT03419403","2019-01-23","AbbVie","ABBV","Recruiting","A Study for Management of Ocular Side Effects in Subjects With Glioblastoma Receiving Depatuxizumab Mafodotin","Temozolomide|Vorsetuzumab mafodotin|Epinephrine","DNA Mtase Inhibitor|Tubulin Inhibitor|Mitosis Inhibitor|ADRB Agonist","Yes","['Vorsetuzumab mafodotin']","Unknown",null,"Phase 3",3,90,"Anticipated","2018-07-30","2019-09-16",{"$nulls":5},"This study will evaluate the effect of several ophthalmologic prophylactic treatment strategies for the management of ocular side effects (OSEs) in participants with epidermal growth factor receptor (EGFR)-amplified glioblastoma (GBM) who are being treated with depatuxizumab mafodotin (ABT-414). The study will include 2 phases during the treatment period: chemoradiation therapy (radiation plus temozolomide [RT/TMZ]) and adjuvant therapy (TMZ ). All participants will receive depatuxizumab mafodotin during both phases of the treatment period plus 1 of 3 prophylactic ophthalmologic treatments (standard steroids [SS], standard steroids with vasoconstrictors and cold compress [SS/VC], and enhanced steroids with vasoconstrictors and cooling compress [ES/VC]).",null,"Phase 3b Study for Management of Ocular Side Effects in Subjects With EGFR-amplified Glioblastoma Receiving Depatuxizumab Mafodotin (ABT-414)","M16-534","Glioblastoma Multiforme","Glioblastoma","Oncology Solid Tumor","Oncology","Experimental","Arm B: Standard Steroids + Vasoconstrictor + Cold Compress|Arm A: Standard Steroid (SS)|Arm C: Enhanced Steroids+Vasoconstrictor+Cold Compress (ES/VC)","Arm B: Steroid eye drop plus vasoconstrictor eye drop and cold compress plus depatuxizumab mafodotin during both the chemoradiation therapy (RT and TMZ) and the adjuvant therapy [TMZ] periods of this study.|Arm A: Steroid Eye Drops plus depatuxizumab mafodotin during both the chemoradiation therapy (radiation [RT] and temozolomide [TMZ]) and the adjuvant therapy [TMZ] periods of this study.|Arm C: Steroid Eye Drop plus ophthalmic steroid ointment plus vasoconstrictor eye drop and cold compresses plus depatuxizumab mafodotin during both the chemoradiation therapy (RT and TMZ) and the adjuvant therapy [TMZ] periods of this study.","Drug","Steroid eye drop|Radiation: Radiation|Temozolomide|depatuxizumab mafodotin|Vasoconstrictor eye drop|Ophthalmic steroid ointment","solution, eye drop|radiation|oral|infusion|ointment","ABT-414\ncold compresscold compress|ABT-414","Arm B: Standard Steroids + Vasoconstrictor + Cold Compress|Arm A: Standard Steroid (SS)|Arm C: Enhanced Steroids+Vasoconstrictor+Cold Compress (ES/VC)","\n\n * Newly diagnosed glioblastoma (GBM) histologically proven, World Health Organization (WHO) grade IV GBM or WHO grade IV gliosarcoma.\n * Tumors must demonstrate epidermal growth factor receptor (EGFR) amplification.\n * Tumors must be supratentorial in location.\n * Participant must have recovered from the effects of surgery, postoperative infection, and other complications; has no significant post-operative hemorrhage.\n * Participant has a Karnofsky performance status (KPS) of 70 or higher.\n * Participant has adequate bone marrow, renal, and hepatic function.\n * Electrocardiogram without evidence of acute cardiac ischemia <= 21 days prior to randomization.\n * Participant has a life expectancy of >= 3 months.\n\n","\n\n * Participants with newly diagnosed GBM: has received prior chemotherapy or radiotherapy for cancer of the head and neck region; has received prior treatment with Gliadel wafers or any other intratumoral or intracavitary treatment.\n * Participant has hypersensitivity to any component of TMZ or dacarbazine.\n * Participant has received anti-cancer therapy (including chemotherapy, immunotherapy, radiotherapy, hormonal, biologic, or any investigational therapy) within 5 years of Study Day 1.\n * Participant has clinically significant uncontrolled condition(s) as described in the protocol.\n * Participant has any medical condition which in the opinion of the investigator places the participant at an unacceptably high risk for toxicities.\n * Participant has had another active malignancy within the past 3 years except for any cancer considered cured or non-melanoma carcinoma of the skin.\n * Participant has a history of herpetic keratitis.\n * Participant is not suitable for receiving ocular steroids with conditions as described in the protocol.\n * Participant has had laser-assisted in situ keratomileusis (LASIK) procedure within the last 1 year or cataract surgery within the last 3 months.\n * Participant has a visual condition that compromises the ability to accurately measure visual acuity or assess visual activities of daily living (vADLs).\n * Participant has hepatitis B virus or hepatitis C virus infection.\n * Participant not receiving treatment with highly active antiretroviral therapy (HAART) when positive for human immunodeficiency virus (HIV).","EGFR","epidermal growth factor receptor","Protein","Ovary, Breast, Lung","Actual","2018-02-05","Actual","Anticipated","2020-03-08","Anticipated","2019-01-01","2018-01-26","2018-01-26","2019-01-18","No","Glioblastoma Multiforme (GBM)\ncancer\nchemoradiation therapy\nepidermal growth factor receptor-amplified glioblastoma\nradiation\ntemozolomide","Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No","Yes\nAbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2017-003171-64","EudraCT Number","Participants who Require a Change in Ocular Side Effect (OSE) Management","Ocular Side Effect (OSE) management is defined as a participant with >= 3-line loss (+ 0.3 on LogMAR scale or equivalent) of best corrected visual acuity from baseline (with prescription at baseline for those using corrective lens), or >= Grade 3 OSE severity on the Corneal Epithelial Adverse Event","CEAE scale.","Cumulative Dose of Depatuxizumab Mafodotin|Change from Baseline In Logarithm of the Minimum Angle of Resolution (LogMAR) Scale after Bandage Contact Lenses (BCL) Intervention|Time to OSE Symptom Resolution after Drug Discontinuation (reversibility)|Time to BCL Intervention|Participants that recover to <3-line decline from Baseline (<= +0.3 LogMAR) in visual acuity after BCL Intervention|Corneal Epithelial Adverse Event (CEAE) Grade|Time to Re-initiation of Depatuxizumab Mafodotin after Dose Interruption|Participants with Depatuxizumab Mafodotin Dose Interruptions due to OSEs|Participants with Depatuxizumab Mafodotin Dose Reductions due to OSEs|Maximum Change from Baseline on LogMAR Scale","Cumulative dose of depatuxizumab mafodotin administered (mg/kg).|Change on LogMAR Scale from last assessment prior to BCL intervention to 2 weeks after BCL intervention. The LogMAR scale measures visual acuity on a continuous scale, with a LogMAR value of 0 equivalent to 20/20 visual acuity. Normal vision is considered to be from -0.2 - 0.1; higher values indicate visual impairment.|Time from discontinuation of depatuxizumab mafodotin to OSE symptom resolution (reversibility).|Time to initiation of bandage contact lenses (BCL) intervention.|Recovery is defined as return to <3-line decline from baseline (<= +0.3 LogMAR) in visual acuity after BCL intervention.|The corneal epithelial adverse event (CEAE) rating scale is designed to record symptoms associated with corneal epitheliopathy caused by antibody-drug conjugates and to grade the severity of findings. The overall CEAE grade is measured on a scale of 0 to 5, with higher values being more severe, reflecting the impact of corneal abnormalities on visual activities of daily living (ADLs). Additional detailed information is collected for specific domains that are commonly affected, with the following ranges (each in order of increasing severity): ocular discomfort (0 - 4), photophobia (0 - 3), and reading (1 - 3).|Time from dose interruption until re-initiation or permanent discontinuation of depatuxizumab mafodotin.|Participants with dose interruptions of depatuxizumab mafodotin due to ocular side effects (OSEs).|Dose reductions of depatuxizumab mafodotin initiated due to OSEs.|The Logarithm of the Minimum Angle of Resolution (LogMAR) scale measures visual acuity on a continuous scale, with a LogMAR value of 0 equivalent to 20/20 visual acuity. Normal vision is considered to be from -0.2 - 0.1; higher values indicate visual impairment.","Up to approximately 18 weeks after initial dose of depatuxizumab mafodotin|Up to approximately 3 years after initial dose of depatuxizumab mafodotin","abbvieclinicaltrials@abbvie.com","ABBVIE CALL CENTER","847.283.8955","Saint Leonards, New South Wales, Australia, 2065 Calvary Mater Newcastle /Id# 169672Waratah, New South Wales, Australia, 2298|Herston, Queensland, Australia, 4029|Heidelberg, Victoria, Australia, 3084|Heidelberg, Baden-Wuerttemberg, Germany, 69120|Leipzig, Sachsen, Germany, 04103|Hamburg, Germany, 20246 Klinikum Univ Regensburg /Id# 169963Regensburg, Germany, 93042 Universitatsklinikum Tubingen /Id# 169965Tuebingen, Germany, 72076|Amsterdam, Netherlands, 1081 Hv Medisch Spectrum Twente /Id# 201603Enschede, Netherlands, 7511 Jx Universitair Medisch Centrum Utrecht /Id# 170149Utrecht, Netherlands, 3584 Cx|London, London, City Of, United Kingdom, Se1 9Rt|Birmingham, United Kingdom, B15 2Th Castle Hill Hospital /Id# 200662Cottingham, United Kingdom, Hu16 5Jq Western General Hospital /Id# 203040Edinburgh, United Kingdom, Eh4 2Xu Freeman Hospital /Id# 200653Newcastle Upon Tyne, United Kingdom, Ne7 7Dn|Los Angeles, California, United States, 90033|Tampa, Florida, United States, 33612|Chicago, Illinois, United States, 60611 Rush University Medical Center /Id# 171003Chicago, Illinois, United States, 60612 Northshore Univ Healthsystem /Id# 164221Skokie, Illinois, United States, 60077 Cdh-Delnor Health System /Id# 169909Warrenville, Illinois, United States, 60555|New York, New York, United States, 10032-3725|Charlotte, North Carolina, United States, 28204 Duke Univ Med Ctr /Id# 170004Durham, North Carolina, United States, 27710|Houston, Texas, United States, 77030 Scott & White Mem Hosp & Clin /Id# 170792Temple, Texas, United States, 76508","California|Florida|Illinois|New York|North Carolina|Texas","Australia|Germany|Netherlands|United Kingdom|United States","New South Wales Royal North Shore Hospital /Id# 169673|Queensland Royal Brisbane And Women's Hospital /Id# 169674|Victoria Austin Hospital /Id# 169671|Baden-Wuerttemberg Universitaetsklinik Heidelberg /Id# 169970|Sachsen Universitaetsklinikum Leipzig /Id# 169969|Univ Klinik Eppendorf Hamburg /Id# 169971|Vrije Universiteit Medisch Centrum /Id# 170152|, London, City Of Guy's And St Thomas' Nhs Found /Id# 207752|Queen Elizabeth Hospital - Birmingham /Id# 200657|Usc /Id# 164235|Moffitt Cancer Center /Id# 164234|Northwestern Medical /Id# 164231|Columbia Univ Medical Center /Id# 164220|Levine Cancer Ins, Carolina Me /Id# 171271|Ut Health Science Ctr-Houston /Id# 164223",{"$nulls":3},"AbbVie Inc.","2019-01-18","2020-05-25T16:40:02.935","2020-05-26T17:10:42.972","NCT03419403"]
["5ecbf4e2feab101b15530a2b","NCT03419403","2019-01-25","AbbVie","ABBV","Recruiting","A Study for Management of Ocular Side Effects in Subjects With Glioblastoma Receiving Depatuxizumab Mafodotin","Temozolomide|Vorsetuzumab mafodotin|Epinephrine","DNA Mtase Inhibitor|Tubulin Inhibitor|Mitosis Inhibitor|ADRB Agonist","Yes","['Vorsetuzumab mafodotin']","Unknown",null,"Phase 3",3,90,"Anticipated","2018-07-30","2019-09-16",{"$nulls":5},"This study will evaluate the effect of several ophthalmologic prophylactic treatment strategies for the management of ocular side effects (OSEs) in participants with epidermal growth factor receptor (EGFR)-amplified glioblastoma (GBM) who are being treated with depatuxizumab mafodotin (ABT-414). The study will include 2 phases during the treatment period: chemoradiation therapy (radiation plus temozolomide [RT/TMZ]) and adjuvant therapy (TMZ ). All participants will receive depatuxizumab mafodotin during both phases of the treatment period plus 1 of 3 prophylactic ophthalmologic treatments (standard steroids [SS], standard steroids with vasoconstrictors and cold compress [SS/VC], and enhanced steroids with vasoconstrictors and cooling compress [ES/VC]).",null,"Phase 3b Study for Management of Ocular Side Effects in Subjects With EGFR-amplified Glioblastoma Receiving Depatuxizumab Mafodotin (ABT-414)","M16-534","Glioblastoma Multiforme","Glioblastoma","Oncology Solid Tumor","Oncology","Experimental","Arm B: Standard Steroids + Vasoconstrictor + Cold Compress|Arm A: Standard Steroid (SS)|Arm C: Enhanced Steroids+Vasoconstrictor+Cold Compress (ES/VC)","Arm B: Steroid eye drop plus vasoconstrictor eye drop and cold compress plus depatuxizumab mafodotin during both the chemoradiation therapy (RT and TMZ) and the adjuvant therapy [TMZ] periods of this study.|Arm A: Steroid Eye Drops plus depatuxizumab mafodotin during both the chemoradiation therapy (radiation [RT] and temozolomide [TMZ]) and the adjuvant therapy [TMZ] periods of this study.|Arm C: Steroid Eye Drop plus ophthalmic steroid ointment plus vasoconstrictor eye drop and cold compresses plus depatuxizumab mafodotin during both the chemoradiation therapy (RT and TMZ) and the adjuvant therapy [TMZ] periods of this study.","Drug","Steroid eye drop|Radiation: Radiation|Temozolomide|depatuxizumab mafodotin|Vasoconstrictor eye drop|Ophthalmic steroid ointment","solution, eye drop|radiation|oral|infusion|ointment","ABT-414\ncold compresscold compress|ABT-414","Arm B: Standard Steroids + Vasoconstrictor + Cold Compress|Arm A: Standard Steroid (SS)|Arm C: Enhanced Steroids+Vasoconstrictor+Cold Compress (ES/VC)","\n\n * Newly diagnosed glioblastoma (GBM) histologically proven, World Health Organization (WHO) grade IV GBM or WHO grade IV gliosarcoma.\n * Tumors must demonstrate epidermal growth factor receptor (EGFR) amplification.\n * Tumors must be supratentorial in location.\n * Participant must have recovered from the effects of surgery, postoperative infection, and other complications; has no significant post-operative hemorrhage.\n * Participant has a Karnofsky performance status (KPS) of 70 or higher.\n * Participant has adequate bone marrow, renal, and hepatic function.\n * Electrocardiogram without evidence of acute cardiac ischemia <= 21 days prior to randomization.\n * Participant has a life expectancy of >= 3 months.\n\n","\n\n * Participants with newly diagnosed GBM: has received prior chemotherapy or radiotherapy for cancer of the head and neck region; has received prior treatment with Gliadel wafers or any other intratumoral or intracavitary treatment.\n * Participant has hypersensitivity to any component of TMZ or dacarbazine.\n * Participant has received anti-cancer therapy (including chemotherapy, immunotherapy, radiotherapy, hormonal, biologic, or any investigational therapy) within 5 years of Study Day 1.\n * Participant has clinically significant uncontrolled condition(s) as described in the protocol.\n * Participant has any medical condition which in the opinion of the investigator places the participant at an unacceptably high risk for toxicities.\n * Participant has had another active malignancy within the past 3 years except for any cancer considered cured or non-melanoma carcinoma of the skin.\n * Participant has a history of herpetic keratitis.\n * Participant is not suitable for receiving ocular steroids with conditions as described in the protocol.\n * Participant has had laser-assisted in situ keratomileusis (LASIK) procedure within the last 1 year or cataract surgery within the last 3 months.\n * Participant has a visual condition that compromises the ability to accurately measure visual acuity or assess visual activities of daily living (vADLs).\n * Participant has hepatitis B virus or hepatitis C virus infection.\n * Participant not receiving treatment with highly active antiretroviral therapy (HAART) when positive for human immunodeficiency virus (HIV).","EGFR","epidermal growth factor receptor","Protein","Ovary, Breast, Lung","Actual","2018-02-05","Actual","Anticipated","2020-03-08","Anticipated","2019-01-01","2018-01-26","2018-01-26","2019-01-23","No","Glioblastoma Multiforme (GBM)\ncancer\nchemoradiation therapy\nepidermal growth factor receptor-amplified glioblastoma\nradiation\ntemozolomide","Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No","Yes\nAbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2017-003171-64","EudraCT Number","Participants who Require a Change in Ocular Side Effect (OSE) Management","Ocular Side Effect (OSE) management is defined as a participant with >= 3-line loss (+ 0.3 on LogMAR scale or equivalent) of best corrected visual acuity from baseline (with prescription at baseline for those using corrective lens), or >= Grade 3 OSE severity on the Corneal Epithelial Adverse Event","CEAE scale.","Cumulative Dose of Depatuxizumab Mafodotin|Change from Baseline In Logarithm of the Minimum Angle of Resolution (LogMAR) Scale after Bandage Contact Lenses (BCL) Intervention|Time to OSE Symptom Resolution after Drug Discontinuation (reversibility)|Time to BCL Intervention|Participants that recover to <3-line decline from Baseline (<= +0.3 LogMAR) in visual acuity after BCL Intervention|Corneal Epithelial Adverse Event (CEAE) Grade|Time to Re-initiation of Depatuxizumab Mafodotin after Dose Interruption|Participants with Depatuxizumab Mafodotin Dose Interruptions due to OSEs|Participants with Depatuxizumab Mafodotin Dose Reductions due to OSEs|Maximum Change from Baseline on LogMAR Scale","Cumulative dose of depatuxizumab mafodotin administered (mg/kg).|Change on LogMAR Scale from last assessment prior to BCL intervention to 2 weeks after BCL intervention. The LogMAR scale measures visual acuity on a continuous scale, with a LogMAR value of 0 equivalent to 20/20 visual acuity. Normal vision is considered to be from -0.2 - 0.1; higher values indicate visual impairment.|Time from discontinuation of depatuxizumab mafodotin to OSE symptom resolution (reversibility).|Time to initiation of bandage contact lenses (BCL) intervention.|Recovery is defined as return to <3-line decline from baseline (<= +0.3 LogMAR) in visual acuity after BCL intervention.|The corneal epithelial adverse event (CEAE) rating scale is designed to record symptoms associated with corneal epitheliopathy caused by antibody-drug conjugates and to grade the severity of findings. The overall CEAE grade is measured on a scale of 0 to 5, with higher values being more severe, reflecting the impact of corneal abnormalities on visual activities of daily living (ADLs). Additional detailed information is collected for specific domains that are commonly affected, with the following ranges (each in order of increasing severity): ocular discomfort (0 - 4), photophobia (0 - 3), and reading (1 - 3).|Time from dose interruption until re-initiation or permanent discontinuation of depatuxizumab mafodotin.|Participants with dose interruptions of depatuxizumab mafodotin due to ocular side effects (OSEs).|Dose reductions of depatuxizumab mafodotin initiated due to OSEs.|The Logarithm of the Minimum Angle of Resolution (LogMAR) scale measures visual acuity on a continuous scale, with a LogMAR value of 0 equivalent to 20/20 visual acuity. Normal vision is considered to be from -0.2 - 0.1; higher values indicate visual impairment.","Up to approximately 18 weeks after initial dose of depatuxizumab mafodotin|Up to approximately 3 years after initial dose of depatuxizumab mafodotin","abbvieclinicaltrials@abbvie.com","ABBVIE CALL CENTER","847.283.8955","Saint Leonards, New South Wales, Australia, 2065 Calvary Mater Newcastle /Id# 169672Waratah, New South Wales, Australia, 2298|Herston, Queensland, Australia, 4029|Heidelberg, Victoria, Australia, 3084|Heidelberg, Baden-Wuerttemberg, Germany, 69120|Leipzig, Sachsen, Germany, 04103|Hamburg, Germany, 20246 Klinikum Univ Regensburg /Id# 169963Regensburg, Germany, 93042 Universitatsklinikum Tubingen /Id# 169965Tuebingen, Germany, 72076|Amsterdam, Netherlands, 1081 Hv Medisch Spectrum Twente /Id# 201603Enschede, Netherlands, 7511 Jx Universitair Medisch Centrum Utrecht /Id# 170149Utrecht, Netherlands, 3584 Cx|London, London, City Of, United Kingdom, Se1 9Rt|Birmingham, United Kingdom, B15 2Th Castle Hill Hospital /Id# 200662Cottingham, United Kingdom, Hu16 5Jq Western General Hospital /Id# 203040Edinburgh, United Kingdom, Eh4 2Xu Freeman Hospital /Id# 200653Newcastle Upon Tyne, United Kingdom, Ne7 7Dn|Los Angeles, California, United States, 90033|Tampa, Florida, United States, 33612|Chicago, Illinois, United States, 60611 Rush University Medical Center /Id# 171003Chicago, Illinois, United States, 60612 Northshore Univ Healthsystem /Id# 164221Skokie, Illinois, United States, 60077 Cdh-Delnor Health System /Id# 169909Warrenville, Illinois, United States, 60555|New York, New York, United States, 10032-3725|Charlotte, North Carolina, United States, 28204 Duke Univ Med Ctr /Id# 170004Durham, North Carolina, United States, 27710|Houston, Texas, United States, 77030 Scott & White Mem Hosp & Clin /Id# 170792Temple, Texas, United States, 76508","California|Florida|Illinois|New York|North Carolina|Texas","Australia|Germany|Netherlands|United Kingdom|United States","New South Wales Royal North Shore Hospital /Id# 169673|Queensland Royal Brisbane And Women's Hospital /Id# 169674|Victoria Austin Hospital /Id# 169671|Baden-Wuerttemberg Universitaetsklinik Heidelberg /Id# 169970|Sachsen Universitaetsklinikum Leipzig /Id# 169969|Univ Klinik Eppendorf Hamburg /Id# 169971|Vrije Universiteit Medisch Centrum /Id# 170152|, London, City Of Guy's And St Thomas' Nhs Found /Id# 207752|Queen Elizabeth Hospital - Birmingham /Id# 200657|Usc /Id# 164235|Moffitt Cancer Center /Id# 164234|Northwestern Medical /Id# 164231|Columbia Univ Medical Center /Id# 164220|Levine Cancer Ins, Carolina Me /Id# 171271|Ut Health Science Ctr-Houston /Id# 164223",{"$nulls":3},"AbbVie Inc.","2019-01-23","2020-05-25T16:40:02.966","2020-05-26T17:10:42.972","NCT03419403"]
["5ecbf4e3e2561b1b11905ef7","NCT03419403","2019-02-28","AbbVie","ABBV","Recruiting","A Study for Management of Ocular Side Effects in Subjects With Glioblastoma Receiving Depatuxizumab Mafodotin","Temozolomide|Vorsetuzumab mafodotin|Epinephrine","DNA Mtase Inhibitor|Tubulin Inhibitor|Mitosis Inhibitor|ADRB Agonist","Yes","['Vorsetuzumab mafodotin']","Unknown",null,"Phase 3",3,90,"Anticipated","2018-07-30","2019-09-16",{"$nulls":5},"This study will evaluate the effect of several ophthalmologic prophylactic treatment strategies for the management of ocular side effects (OSEs) in participants with epidermal growth factor receptor (EGFR)-amplified glioblastoma (GBM) who are being treated with depatuxizumab mafodotin (ABT-414). The study will include 2 phases during the treatment period: chemoradiation therapy (radiation plus temozolomide [RT/TMZ]) and adjuvant therapy (TMZ ). All participants will receive depatuxizumab mafodotin during both phases of the treatment period plus 1 of 3 prophylactic ophthalmologic treatments (standard steroids [SS], standard steroids with vasoconstrictors and cold compress [SS/VC], and enhanced steroids with vasoconstrictors and cooling compress [ES/VC]).",null,"Phase 3b Study for Management of Ocular Side Effects in Subjects With EGFR-amplified Glioblastoma Receiving Depatuxizumab Mafodotin (ABT-414)","M16-534","Glioblastoma Multiforme","Glioblastoma","Oncology Solid Tumor","Oncology","Experimental","Arm B: Standard Steroids + Vasoconstrictor + Cold Compress|Arm A: Standard Steroid (SS)|Arm C: Enhanced Steroids+Vasoconstrictor+Cold Compress (ES/VC)","Arm B: Steroid eye drop plus vasoconstrictor eye drop and cold compress plus depatuxizumab mafodotin during both the chemoradiation therapy (RT and TMZ) and the adjuvant therapy [TMZ] periods of this study.|Arm A: Steroid Eye Drops plus depatuxizumab mafodotin during both the chemoradiation therapy (radiation [RT] and temozolomide [TMZ]) and the adjuvant therapy [TMZ] periods of this study.|Arm C: Steroid Eye Drop plus ophthalmic steroid ointment plus vasoconstrictor eye drop and cold compresses plus depatuxizumab mafodotin during both the chemoradiation therapy (RT and TMZ) and the adjuvant therapy [TMZ] periods of this study.","Drug","Steroid eye drop|Radiation: Radiation|Temozolomide|depatuxizumab mafodotin|Vasoconstrictor eye drop|Ophthalmic steroid ointment","solution, eye drop|radiation|oral|infusion|ointment","ABT-414\ncold compresscold compress|ABT-414","Arm B: Standard Steroids + Vasoconstrictor + Cold Compress|Arm A: Standard Steroid (SS)|Arm C: Enhanced Steroids+Vasoconstrictor+Cold Compress (ES/VC)","\n\n * Newly diagnosed glioblastoma (GBM) histologically proven, World Health Organization (WHO) grade IV GBM or WHO grade IV gliosarcoma.\n * Tumors must demonstrate epidermal growth factor receptor (EGFR) amplification.\n * Tumors must be supratentorial in location.\n * Participant must have recovered from the effects of surgery, postoperative infection, and other complications; has no significant post-operative hemorrhage.\n * Participant has a Karnofsky performance status (KPS) of 70 or higher.\n * Participant has adequate bone marrow, renal, and hepatic function.\n * Electrocardiogram without evidence of acute cardiac ischemia <= 21 days prior to randomization.\n * Participant has a life expectancy of >= 3 months.\n\n","\n\n * Participants with newly diagnosed GBM: has received prior chemotherapy or radiotherapy for cancer of the head and neck region; has received prior treatment with Gliadel wafers or any other intratumoral or intracavitary treatment.\n * Participant has hypersensitivity to any component of TMZ or dacarbazine.\n * Participant has received anti-cancer therapy (including chemotherapy, immunotherapy, radiotherapy, hormonal, biologic, or any investigational therapy) within 5 years of Study Day 1.\n * Participant has clinically significant uncontrolled condition(s) as described in the protocol.\n * Participant has any medical condition which in the opinion of the investigator places the participant at an unacceptably high risk for toxicities.\n * Participant has had another active malignancy within the past 3 years except for any cancer considered cured or non-melanoma carcinoma of the skin.\n * Participant has a history of herpetic keratitis.\n * Participant is not suitable for receiving ocular steroids with conditions as described in the protocol.\n * Participant has had laser-assisted in situ keratomileusis (LASIK) procedure within the last 1 year or cataract surgery within the last 3 months.\n * Participant has a visual condition that compromises the ability to accurately measure visual acuity or assess visual activities of daily living (vADLs).\n * Participant has hepatitis B virus or hepatitis C virus infection.\n * Participant not receiving treatment with highly active antiretroviral therapy (HAART) when positive for human immunodeficiency virus (HIV).","EGFR","epidermal growth factor receptor","Protein","Ovary, Breast, Lung","Actual","2018-02-05","Actual","Anticipated","2020-02-16","Anticipated","2019-02-01","2018-01-26","2018-01-26","2019-02-27","No","Glioblastoma Multiforme (GBM)\ncancer\nchemoradiation therapy\nepidermal growth factor receptor-amplified glioblastoma\nradiation\ntemozolomide","Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No","Yes\nAbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2017-003171-64","EudraCT Number","Participants who Require a Change in Ocular Side Effect (OSE) Management","Ocular Side Effect (OSE) management is defined as a participant with >= 3-line loss (+ 0.3 on LogMAR scale or equivalent) of best corrected visual acuity from baseline (with prescription at baseline for those using corrective lens), or >= Grade 3 OSE severity on the Corneal Epithelial Adverse Event","CEAE scale.","Cumulative Dose of Depatuxizumab Mafodotin|Change from Baseline In Logarithm of the Minimum Angle of Resolution (LogMAR) Scale after Bandage Contact Lenses (BCL) Intervention|Time to OSE Symptom Resolution after Drug Discontinuation (reversibility)|Time to BCL Intervention|Participants that recover to <3-line decline from Baseline (<= +0.3 LogMAR) in visual acuity after BCL Intervention|Corneal Epithelial Adverse Event (CEAE) Grade|Time to Re-initiation of Depatuxizumab Mafodotin after Dose Interruption|Participants with Depatuxizumab Mafodotin Dose Interruptions due to OSEs|Participants with Depatuxizumab Mafodotin Dose Reductions due to OSEs|Maximum Change from Baseline on LogMAR Scale","Cumulative dose of depatuxizumab mafodotin administered (mg/kg).|Change on LogMAR Scale from last assessment prior to BCL intervention to 2 weeks after BCL intervention. The LogMAR scale measures visual acuity on a continuous scale, with a LogMAR value of 0 equivalent to 20/20 visual acuity. Normal vision is considered to be from -0.2 - 0.1; higher values indicate visual impairment.|Time from discontinuation of depatuxizumab mafodotin to OSE symptom resolution (reversibility).|Time to initiation of bandage contact lenses (BCL) intervention.|Recovery is defined as return to <3-line decline from baseline (<= +0.3 LogMAR) in visual acuity after BCL intervention.|The corneal epithelial adverse event (CEAE) rating scale is designed to record symptoms associated with corneal epitheliopathy caused by antibody-drug conjugates and to grade the severity of findings. The overall CEAE grade is measured on a scale of 0 to 5, with higher values being more severe, reflecting the impact of corneal abnormalities on visual activities of daily living (ADLs). Additional detailed information is collected for specific domains that are commonly affected, with the following ranges (each in order of increasing severity): ocular discomfort (0 - 4), photophobia (0 - 3), and reading (1 - 3).|Time from dose interruption until re-initiation or permanent discontinuation of depatuxizumab mafodotin.|Participants with dose interruptions of depatuxizumab mafodotin due to ocular side effects (OSEs).|Dose reductions of depatuxizumab mafodotin initiated due to OSEs.|The Logarithm of the Minimum Angle of Resolution (LogMAR) scale measures visual acuity on a continuous scale, with a LogMAR value of 0 equivalent to 20/20 visual acuity. Normal vision is considered to be from -0.2 - 0.1; higher values indicate visual impairment.","Up to approximately 18 weeks after initial dose of depatuxizumab mafodotin|Up to approximately 3 years after initial dose of depatuxizumab mafodotin","abbvieclinicaltrials@abbvie.com","ABBVIE CALL CENTER","847.283.8955","Saint Leonards, New South Wales, Australia, 2065 Calvary Mater Newcastle /Id# 169672Waratah, New South Wales, Australia, 2298|Herston, Queensland, Australia, 4029|Heidelberg, Victoria, Australia, 3084|Paris, France, 75651|St Herblain Cedex, Loire-Atlantique, France, 44805|Marseille Cedex 05, Provence-Alpes-Cote-D Azur, France, 13385|Heidelberg, Baden-Wuerttemberg, Germany, 69120|Leipzig, Sachsen, Germany, 04103|Hamburg, Germany, 20246 Klinikum Univ Regensburg /Id# 169963Regensburg, Germany, 93042 Universitatsklinikum Tubingen /Id# 169965Tuebingen, Germany, 72076|Amsterdam, Netherlands, 1081 Hv Medisch Spectrum Twente /Id# 201603Enschede, Netherlands, 7511 Jx Universitair Medisch Centrum Utrecht /Id# 170149Utrecht, Netherlands, 3584 Cx|London, London, City Of, United Kingdom, Se1 9Rt|Birmingham, United Kingdom, B15 2Th Castle Hill Hospital /Id# 200662Cottingham, United Kingdom, Hu16 5Jq Western General Hospital /Id# 203040Edinburgh, United Kingdom, Eh4 2Xu Freeman Hospital /Id# 200653Newcastle Upon Tyne, United Kingdom, Ne7 7Dn|Los Angeles, California, United States, 90033|Tampa, Florida, United States, 33612|Chicago, Illinois, United States, 60611 Rush University Medical Center /Id# 171003Chicago, Illinois, United States, 60612 Northshore University Healthsystem - Skokie /Id# 164221Skokie, Illinois, United States, 60077 Cdh-Delnor Health System /Id# 169909Warrenville, Illinois, United States, 60555|New York, New York, United States, 10032-3725|Charlotte, North Carolina, United States, 28204 Duke Univ Med Ctr /Id# 170004Durham, North Carolina, United States, 27710|Houston, Texas, United States, 77030 Scott & White Mem Hosp & Clin /Id# 170792Temple, Texas, United States, 76508","California|Florida|Illinois|New York|North Carolina|Texas","Australia|France|Germany|Netherlands|United Kingdom|United States","New South Wales Royal North Shore Hospital /Id# 169673|Queensland Royal Brisbane And Women's Hospital /Id# 169674|Victoria Austin Hospital /Id# 169671|Hopital Pitie Salpetriere /Id# 209082|Loire-Atlantique Institut De Cancer De L'Ouest /Id# 209084|Provence-Alpes-Cote-D Azur Hopital De La Timone /Id# 209057|Baden-Wuerttemberg Universitaetsklinik Heidelberg /Id# 169970|Sachsen Universitaetsklinikum Leipzig /Id# 169969|Univ Klinik Eppendorf Hamburg /Id# 169971|Vrije Universiteit Medisch Centrum /Id# 170152|, London, City Of Guy's And St Thomas' Nhs Found /Id# 207752|Queen Elizabeth Hospital - Birmingham /Id# 200657|Usc /Id# 164235|Moffitt Cancer Center /Id# 164234|Northwestern Medical /Id# 164231|Columbia Univ Medical Center /Id# 164220|Levine Cancer Ins, Carolina Me /Id# 171271|Ut Health Science Ctr-Houston /Id# 164223",{"$nulls":3},"AbbVie Inc.","2019-02-27","2020-05-25T16:40:03.085","2020-05-26T17:10:42.972","NCT03419403"]
["5ecbf4e3307e3d1b1f8d9e8e","NCT03419403","2019-03-13","AbbVie","ABBV","Recruiting","UNITE Study: Understanding New Interventions With GBM ThErapy","Temozolomide|Vorsetuzumab mafodotin|Epinephrine","DNA Mtase Inhibitor|Tubulin Inhibitor|Mitosis Inhibitor|ADRB Agonist","Yes","['Vorsetuzumab mafodotin']","Unknown",null,"Phase 3",3,90,"Anticipated","2018-07-30","2019-09-16",{"$nulls":5},"This study will evaluate the effect of several ophthalmologic prophylactic treatment strategies for the management of ocular side effects (OSEs) in participants with epidermal growth factor receptor (EGFR)-amplified glioblastoma (GBM) who are being treated with depatuxizumab mafodotin (ABT-414). The study will include 2 phases during the treatment period: chemoradiation therapy (radiation plus temozolomide [RT/TMZ]) and adjuvant therapy (TMZ ). All participants will receive depatuxizumab mafodotin during both phases of the treatment period plus 1 of 3 prophylactic ophthalmologic treatments (standard steroids [SS], standard steroids with vasoconstrictors and cold compress [SS/VC], and enhanced steroids with vasoconstrictors and cooling compress [ES/VC]).",null,"Phase 3b Study for Management of Ocular Side Effects in Subjects With EGFR-amplified Glioblastoma Receiving Depatuxizumab Mafodotin (ABT-414)","M16-534","Glioblastoma Multiforme","Glioblastoma","Oncology Solid Tumor","Oncology","Experimental","Arm B: Standard Steroids + Vasoconstrictor + Cold Compress|Arm A: Standard Steroid (SS)|Arm C: Enhanced Steroids+Vasoconstrictor+Cold Compress (ES/VC)","Arm B: Steroid eye drop plus vasoconstrictor eye drop and cold compress plus depatuxizumab mafodotin during both the chemoradiation therapy (RT and TMZ) and the adjuvant therapy [TMZ] periods of this study.|Arm A: Steroid Eye Drops plus depatuxizumab mafodotin during both the chemoradiation therapy (radiation [RT] and temozolomide [TMZ]) and the adjuvant therapy [TMZ] periods of this study.|Arm C: Steroid Eye Drop plus ophthalmic steroid ointment plus vasoconstrictor eye drop and cold compresses plus depatuxizumab mafodotin during both the chemoradiation therapy (RT and TMZ) and the adjuvant therapy [TMZ] periods of this study.","Drug","Steroid eye drop|Radiation: Radiation|Temozolomide|depatuxizumab mafodotin|Vasoconstrictor eye drop|Ophthalmic steroid ointment","solution, eye drop|radiation|oral|infusion|ointment","ABT-414\ncold compresscold compress|ABT-414","Arm B: Standard Steroids + Vasoconstrictor + Cold Compress|Arm A: Standard Steroid (SS)|Arm C: Enhanced Steroids+Vasoconstrictor+Cold Compress (ES/VC)","\n\n * Newly diagnosed glioblastoma (GBM) histologically proven, World Health Organization (WHO) grade IV GBM or WHO grade IV gliosarcoma.\n * Tumors must demonstrate epidermal growth factor receptor (EGFR) amplification.\n * Tumors must be supratentorial in location.\n * Participant must have recovered from the effects of surgery, postoperative infection, and other complications; has no significant post-operative hemorrhage.\n * Participant has a Karnofsky performance status (KPS) of 70 or higher.\n * Participant has adequate bone marrow, renal, and hepatic function.\n * Electrocardiogram without evidence of acute cardiac ischemia <= 21 days prior to randomization.\n * Participant has a life expectancy of >= 3 months.\n\n","\n\n * Participants with newly diagnosed GBM: has received prior chemotherapy or radiotherapy for cancer of the head and neck region; has received prior treatment with Gliadel wafers or any other intratumoral or intracavitary treatment.\n * Participant has hypersensitivity to any component of TMZ or dacarbazine.\n * Participant has received anti-cancer therapy (including chemotherapy, immunotherapy, radiotherapy, hormonal, biologic, or any investigational therapy) within 5 years of Study Day 1.\n * Participant has clinically significant uncontrolled condition(s) as described in the protocol.\n * Participant has any medical condition which in the opinion of the investigator places the participant at an unacceptably high risk for toxicities.\n * Participant has had another active malignancy within the past 3 years except for any cancer considered cured or non-melanoma carcinoma of the skin.\n * Participant has a history of herpetic keratitis.\n * Participant is not suitable for receiving ocular steroids with conditions as described in the protocol.\n * Participant has had laser-assisted in situ keratomileusis (LASIK) procedure within the last 1 year or cataract surgery within the last 3 months.\n * Participant has a visual condition that compromises the ability to accurately measure visual acuity or assess visual activities of daily living (vADLs).\n * Participant has hepatitis B virus or hepatitis C virus infection.\n * Participant not receiving treatment with highly active antiretroviral therapy (HAART) when positive for human immunodeficiency virus (HIV).","EGFR","epidermal growth factor receptor","Protein","Ovary, Breast, Lung","Actual","2018-02-05","Actual","Anticipated","2020-02-16","Anticipated","2019-03-01","2018-01-26","2018-01-26","2019-03-11","No","Glioblastoma Multiforme (GBM)\ncancer\nchemoradiation therapy\nepidermal growth factor receptor-amplified glioblastoma\nradiation\ntemozolomide","Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No","Yes\nAbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2017-003171-64","EudraCT Number","Participants who Require a Change in Ocular Side Effect (OSE) Management","Ocular Side Effect (OSE) management is defined as a participant with >= 3-line loss (+ 0.3 on LogMAR scale or equivalent) of best corrected visual acuity from baseline (with prescription at baseline for those using corrective lens), or >= Grade 3 OSE severity on the Corneal Epithelial Adverse Event","CEAE scale.","Cumulative Dose of Depatuxizumab Mafodotin|Change from Baseline In Logarithm of the Minimum Angle of Resolution (LogMAR) Scale after Bandage Contact Lenses (BCL) Intervention|Time to OSE Symptom Resolution after Drug Discontinuation (reversibility)|Time to BCL Intervention|Participants that recover to <3-line decline from Baseline (<= +0.3 LogMAR) in visual acuity after BCL Intervention|Corneal Epithelial Adverse Event (CEAE) Grade|Time to Re-initiation of Depatuxizumab Mafodotin after Dose Interruption|Participants with Depatuxizumab Mafodotin Dose Interruptions due to OSEs|Participants with Depatuxizumab Mafodotin Dose Reductions due to OSEs|Maximum Change from Baseline on LogMAR Scale","Cumulative dose of depatuxizumab mafodotin administered (mg/kg).|Change on LogMAR Scale from last assessment prior to BCL intervention to 2 weeks after BCL intervention. The LogMAR scale measures visual acuity on a continuous scale, with a LogMAR value of 0 equivalent to 20/20 visual acuity. Normal vision is considered to be from -0.2 - 0.1; higher values indicate visual impairment.|Time from discontinuation of depatuxizumab mafodotin to OSE symptom resolution (reversibility).|Time to initiation of bandage contact lenses (BCL) intervention.|Recovery is defined as return to <3-line decline from baseline (<= +0.3 LogMAR) in visual acuity after BCL intervention.|The corneal epithelial adverse event (CEAE) rating scale is designed to record symptoms associated with corneal epitheliopathy caused by antibody-drug conjugates and to grade the severity of findings. The overall CEAE grade is measured on a scale of 0 to 5, with higher values being more severe, reflecting the impact of corneal abnormalities on visual activities of daily living (ADLs). Additional detailed information is collected for specific domains that are commonly affected, with the following ranges (each in order of increasing severity): ocular discomfort (0 - 4), photophobia (0 - 3), and reading (1 - 3).|Time from dose interruption until re-initiation or permanent discontinuation of depatuxizumab mafodotin.|Participants with dose interruptions of depatuxizumab mafodotin due to ocular side effects (OSEs).|Dose reductions of depatuxizumab mafodotin initiated due to OSEs.|The Logarithm of the Minimum Angle of Resolution (LogMAR) scale measures visual acuity on a continuous scale, with a LogMAR value of 0 equivalent to 20/20 visual acuity. Normal vision is considered to be from -0.2 - 0.1; higher values indicate visual impairment.","Up to approximately 18 weeks after initial dose of depatuxizumab mafodotin|Up to approximately 3 years after initial dose of depatuxizumab mafodotin","abbvieclinicaltrials@abbvie.com","ABBVIE CALL CENTER","847.283.8955","Saint Leonards, New South Wales, Australia, 2065 Calvary Mater Newcastle /Id# 169672Waratah, New South Wales, Australia, 2298|Herston, Queensland, Australia, 4029|Heidelberg, Victoria, Australia, 3084|Paris, France, 75651|St Herblain Cedex, Loire-Atlantique, France, 44805|Marseille Cedex 05, Provence-Alpes-Cote-D Azur, France, 13385|Heidelberg, Baden-Wuerttemberg, Germany, 69120|Leipzig, Sachsen, Germany, 04103|Hamburg, Germany, 20246 Klinikum Univ Regensburg /Id# 169963Regensburg, Germany, 93042 Universitatsklinikum Tubingen /Id# 169965Tuebingen, Germany, 72076|Amsterdam, Netherlands, 1081 Hv Medisch Spectrum Twente /Id# 201603Enschede, Netherlands, 7511 Jx Universitair Medisch Centrum Utrecht /Id# 170149Utrecht, Netherlands, 3584 Cx|London, London, City Of, United Kingdom, Se1 9Rt|Birmingham, United Kingdom, B15 2Th Castle Hill Hospital /Id# 200662Cottingham, United Kingdom, Hu16 5Jq Western General Hospital /Id# 203040Edinburgh, United Kingdom, Eh4 2Xu Freeman Hospital /Id# 200653Newcastle Upon Tyne, United Kingdom, Ne7 7Dn|Los Angeles, California, United States, 90033|Tampa, Florida, United States, 33612|Chicago, Illinois, United States, 60611 Rush University Medical Center /Id# 171003Chicago, Illinois, United States, 60612 Northshore University Healthsystem - Skokie /Id# 164221Skokie, Illinois, United States, 60077 Cdh-Delnor Health System /Id# 169909Warrenville, Illinois, United States, 60555|New York, New York, United States, 10032-3725|Charlotte, North Carolina, United States, 28204 Duke Univ Med Ctr /Id# 170004Durham, North Carolina, United States, 27710|Houston, Texas, United States, 77030 Scott & White Mem Hosp & Clin /Id# 170792Temple, Texas, United States, 76508","California|Florida|Illinois|New York|North Carolina|Texas","Australia|France|Germany|Netherlands|United Kingdom|United States","New South Wales Royal North Shore Hospital /Id# 169673|Queensland Royal Brisbane And Women's Hospital /Id# 169674|Victoria Austin Hospital /Id# 169671|Hopital Pitie Salpetriere /Id# 209082|Loire-Atlantique Institut De Cancer De L'Ouest /Id# 209084|Provence-Alpes-Cote-D Azur Hopital De La Timone /Id# 209057|Baden-Wuerttemberg Universitaetsklinik Heidelberg /Id# 169970|Sachsen Universitaetsklinikum Leipzig /Id# 169969|Univ Klinik Eppendorf Hamburg /Id# 169971|Vrije Universiteit Medisch Centrum /Id# 170152|, London, City Of Guy's And St Thomas' Nhs Found /Id# 207752|Queen Elizabeth Hospital - Birmingham /Id# 200657|Usc /Id# 164235|Moffitt Cancer Center /Id# 164234|Northwestern Medical /Id# 164231|Columbia Univ Medical Center /Id# 164220|Levine Cancer Ins, Carolina Me /Id# 171271|Ut Health Science Ctr-Houston /Id# 164223",{"$nulls":3},"AbbVie Inc.","2019-03-11","2020-05-25T16:40:03.125","2020-05-26T17:10:42.972","NCT03419403"]
["5ecbf4e311702c1b1b916c09","NCT03419403","2019-05-10","AbbVie","ABBV","Recruiting","UNITE Study: Understanding New Interventions With GBM ThErapy","Temozolomide|Vorsetuzumab mafodotin|Epinephrine","DNA Mtase Inhibitor|Tubulin Inhibitor|Mitosis Inhibitor|ADRB Agonist","Yes","['Vorsetuzumab mafodotin']","Unknown",null,"Phase 3",3,90,"Anticipated","2018-07-30","2019-09-16",{"$nulls":5},"This study will evaluate the effect of several ophthalmologic prophylactic treatment strategies for the management of ocular side effects (OSEs) in participants with epidermal growth factor receptor (EGFR)-amplified glioblastoma (GBM) who are being treated with depatuxizumab mafodotin (ABT-414). The study will include 2 phases during the treatment period: chemoradiation therapy (radiation plus temozolomide [RT/TMZ]) and adjuvant therapy (TMZ ). All participants will receive depatuxizumab mafodotin during both phases of the treatment period plus 1 of 3 prophylactic ophthalmologic treatments (standard steroids [SS], standard steroids with vasoconstrictors and cold compress [SS/VC], and enhanced steroids with vasoconstrictors and cooling compress [ES/VC]).",null,"Phase 3b Study for Management of Ocular Side Effects in Subjects With EGFR-amplified Glioblastoma Receiving Depatuxizumab Mafodotin (ABT-414)","M16-534","Glioblastoma Multiforme","Glioblastoma","Oncology Solid Tumor","Oncology","Experimental","Arm B: Standard Steroids + Vasoconstrictor + Cold Compress|Arm A: Standard Steroid (SS)|Arm C: Enhanced Steroids+Vasoconstrictor+Cold Compress (ES/VC)","Arm B: Steroid eye drop plus vasoconstrictor eye drop and cold compress plus depatuxizumab mafodotin during both the chemoradiation therapy (RT and TMZ) and the adjuvant therapy [TMZ] periods of this study.|Arm A: Steroid Eye Drops plus depatuxizumab mafodotin during both the chemoradiation therapy (radiation [RT] and temozolomide [TMZ]) and the adjuvant therapy [TMZ] periods of this study.|Arm C: Steroid Eye Drop plus ophthalmic steroid ointment plus vasoconstrictor eye drop and cold compresses plus depatuxizumab mafodotin during both the chemoradiation therapy (RT and TMZ) and the adjuvant therapy [TMZ] periods of this study.","Drug","Steroid eye drop|Radiation: Radiation|Temozolomide|depatuxizumab mafodotin|Vasoconstrictor eye drop|Ophthalmic steroid ointment","solution, eye drop|radiation|oral|infusion|ointment","ABT-414\ncold compresscold compress|ABT-414","Arm B: Standard Steroids + Vasoconstrictor + Cold Compress|Arm A: Standard Steroid (SS)|Arm C: Enhanced Steroids+Vasoconstrictor+Cold Compress (ES/VC)","\n\n * Newly diagnosed glioblastoma (GBM) histologically proven, World Health Organization (WHO) grade IV GBM or WHO grade IV gliosarcoma.\n * Tumors must demonstrate epidermal growth factor receptor (EGFR) amplification.\n * Tumors must be supratentorial in location.\n * Participant must have recovered from the effects of surgery, postoperative infection, and other complications; has no significant post-operative hemorrhage.\n * Participant has a Karnofsky performance status (KPS) of 70 or higher.\n * Participant has adequate bone marrow, renal, and hepatic function.\n * Electrocardiogram without evidence of acute cardiac ischemia <= 21 days prior to randomization.\n * Participant has a life expectancy of >= 3 months.\n\n","\n\n * Participants with newly diagnosed GBM: has received prior chemotherapy or radiotherapy for cancer of the head and neck region; has received prior treatment with Gliadel wafers or any other intratumoral or intracavitary treatment.\n * Participant has hypersensitivity to any component of TMZ or dacarbazine.\n * Participant has received anti-cancer therapy (including chemotherapy, immunotherapy, radiotherapy, hormonal, biologic, or any investigational therapy) within 5 years of Study Day 1.\n * Participant has clinically significant uncontrolled condition(s) as described in the protocol.\n * Participant has any medical condition which in the opinion of the investigator places the participant at an unacceptably high risk for toxicities.\n * Participant has had another active malignancy within the past 3 years except for any cancer considered cured or non-melanoma carcinoma of the skin.\n * Participant has a history of herpetic keratitis.\n * Participant is not suitable for receiving ocular steroids with conditions as described in the protocol.\n * Participant has had laser-assisted in situ keratomileusis (LASIK) procedure within the last 1 year or cataract surgery within the last 3 months.\n * Participant has a visual condition that compromises the ability to accurately measure visual acuity or assess visual activities of daily living (vADLs).\n * Participant has hepatitis B virus or hepatitis C virus infection.\n * Participant not receiving treatment with highly active antiretroviral therapy (HAART) when positive for human immunodeficiency virus (HIV).","EGFR","epidermal growth factor receptor","Protein","Ovary, Breast, Lung","Actual","2018-02-05","Actual","Anticipated","2020-02-16","Anticipated","2019-05-01","2018-01-26","2018-01-26","2019-05-08","No","Glioblastoma Multiforme (GBM)\ncancer\nchemoradiation therapy\nepidermal growth factor receptor-amplified glioblastoma\nradiation\ntemozolomide","Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No","Yes\nAbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2017-003171-64","EudraCT Number","Participants who Require a Change in Ocular Side Effect (OSE) Management","Ocular Side Effect (OSE) management is defined as a participant with >= 3-line loss (+ 0.3 on LogMAR scale or equivalent) of best corrected visual acuity from baseline (with prescription at baseline for those using corrective lens), or >= Grade 3 OSE severity on the Corneal Epithelial Adverse Event","CEAE scale.","Cumulative Dose of Depatuxizumab Mafodotin|Change from Baseline In Logarithm of the Minimum Angle of Resolution (LogMAR) Scale after Bandage Contact Lenses (BCL) Intervention|Time to OSE Symptom Resolution after Drug Discontinuation (reversibility)|Time to BCL Intervention|Participants that recover to <3-line decline from Baseline (<= +0.3 LogMAR) in visual acuity after BCL Intervention|Corneal Epithelial Adverse Event (CEAE) Grade|Time to Re-initiation of Depatuxizumab Mafodotin after Dose Interruption|Participants with Depatuxizumab Mafodotin Dose Interruptions due to OSEs|Participants with Depatuxizumab Mafodotin Dose Reductions due to OSEs|Maximum Change from Baseline on LogMAR Scale","Cumulative dose of depatuxizumab mafodotin administered (mg/kg).|Change on LogMAR Scale from last assessment prior to BCL intervention to 2 weeks after BCL intervention. The LogMAR scale measures visual acuity on a continuous scale, with a LogMAR value of 0 equivalent to 20/20 visual acuity. Normal vision is considered to be from -0.2 - 0.1; higher values indicate visual impairment.|Time from discontinuation of depatuxizumab mafodotin to OSE symptom resolution (reversibility).|Time to initiation of bandage contact lenses (BCL) intervention.|Recovery is defined as return to <3-line decline from baseline (<= +0.3 LogMAR) in visual acuity after BCL intervention.|The corneal epithelial adverse event (CEAE) rating scale is designed to record symptoms associated with corneal epitheliopathy caused by antibody-drug conjugates and to grade the severity of findings. The overall CEAE grade is measured on a scale of 0 to 5, with higher values being more severe, reflecting the impact of corneal abnormalities on visual activities of daily living (ADLs). Additional detailed information is collected for specific domains that are commonly affected, with the following ranges (each in order of increasing severity): ocular discomfort (0 - 4), photophobia (0 - 3), and reading (1 - 3).|Time from dose interruption until re-initiation or permanent discontinuation of depatuxizumab mafodotin.|Participants with dose interruptions of depatuxizumab mafodotin due to ocular side effects (OSEs).|Dose reductions of depatuxizumab mafodotin initiated due to OSEs.|The Logarithm of the Minimum Angle of Resolution (LogMAR) scale measures visual acuity on a continuous scale, with a LogMAR value of 0 equivalent to 20/20 visual acuity. Normal vision is considered to be from -0.2 - 0.1; higher values indicate visual impairment.","Up to approximately 18 weeks after initial dose of depatuxizumab mafodotin|Up to approximately 3 years after initial dose of depatuxizumab mafodotin","abbvieclinicaltrials@abbvie.com","ABBVIE CALL CENTER","847.283.8955","Saint Leonards, New South Wales, Australia, 2065 Calvary Mater Newcastle /Id# 169672Waratah, New South Wales, Australia, 2298|Herston, Queensland, Australia, 4029|Heidelberg, Victoria, Australia, 3084|Paris, France, 75651|St Herblain Cedex, Loire-Atlantique, France, 44805|Marseille Cedex 05, Provence-Alpes-Cote-D Azur, France, 13385|Heidelberg, Baden-Wuerttemberg, Germany, 69120|Leipzig, Sachsen, Germany, 04103|Hamburg, Germany, 20246 Klinikum Univ Regensburg /Id# 169963Regensburg, Germany, 93042 Universitatsklinikum Tubingen /Id# 169965Tuebingen, Germany, 72076|Amsterdam, Netherlands, 1081 Hv Medisch Spectrum Twente /Id# 201603Enschede, Netherlands, 7511 Jx Universitair Medisch Centrum Utrecht /Id# 170149Utrecht, Netherlands, 3584 Cx|London, London, City Of, United Kingdom, Se1 9Rt|Birmingham, United Kingdom, B15 2Th Castle Hill Hospital /Id# 200662Cottingham, United Kingdom, Hu16 5Jq Western General Hospital /Id# 203040Edinburgh, United Kingdom, Eh4 2Xu Freeman Hospital /Id# 200653Newcastle Upon Tyne, United Kingdom, Ne7 7Dn|Los Angeles, California, United States, 90033|Tampa, Florida, United States, 33612|Chicago, Illinois, United States, 60611 Rush University Medical Center /Id# 171003Chicago, Illinois, United States, 60612 Northshore University Healthsystem - Skokie /Id# 164221Skokie, Illinois, United States, 60077 Cdh-Delnor Health System /Id# 169909Warrenville, Illinois, United States, 60555|New York, New York, United States, 10032-3725|Charlotte, North Carolina, United States, 28204|Houston, Texas, United States, 77030 Scott & White Mem Hosp & Clin /Id# 170792Temple, Texas, United States, 76508","California|Florida|Illinois|New York|North Carolina|Texas","Australia|France|Germany|Netherlands|United Kingdom|United States","New South Wales Royal North Shore Hospital /Id# 169673|Queensland Royal Brisbane And Women's Hospital /Id# 169674|Victoria Austin Hospital /Id# 169671|Hopital Pitie Salpetriere /Id# 209082|Loire-Atlantique Institut De Cancer De L'Ouest /Id# 209084|Provence-Alpes-Cote-D Azur Hopital De La Timone /Id# 209057|Baden-Wuerttemberg Universitaetsklinik Heidelberg /Id# 169970|Sachsen Universitaetsklinikum Leipzig /Id# 169969|Univ Klinik Eppendorf Hamburg /Id# 169971|Vrije Universiteit Medisch Centrum /Id# 170152|, London, City Of Guy's And St Thomas' Nhs Found /Id# 207752|Queen Elizabeth Hospital - Birmingham /Id# 200657|Usc /Id# 164235|Moffitt Cancer Center /Id# 164234|Northwestern Medical /Id# 164231|Columbia Univ Medical Center /Id# 164220|Levine Cancer Ins, Carolina Me /Id# 171271|Ut Health Science Ctr-Houston /Id# 164223",{"$nulls":3},"AbbVie Inc.","2019-05-08","2020-05-25T16:40:03.341","2020-05-26T17:10:42.972","NCT03419403"]
["5ecbf4e3fe30261b1a0483fd","NCT03419403","2019-05-28","AbbVie","ABBV","Active, not recruiting","UNITE Study: Understanding New Interventions With GBM ThErapy","Temozolomide|Vorsetuzumab mafodotin|Epinephrine","DNA Mtase Inhibitor|Tubulin Inhibitor|Mitosis Inhibitor|ADRB Agonist","Yes","['Vorsetuzumab mafodotin']","Unknown",null,"Phase 3",3,40,"Actual","2018-07-30","2019-09-16",{"$nulls":5},"This study will evaluate the effect of several ophthalmologic prophylactic treatment strategies for the management of ocular side effects (OSEs) in participants with epidermal growth factor receptor (EGFR)-amplified glioblastoma (GBM) who are being treated with depatuxizumab mafodotin (ABT-414). The study will include 2 phases during the treatment period: chemoradiation therapy (radiation plus temozolomide [RT/TMZ]) and adjuvant therapy (TMZ ). All participants will receive depatuxizumab mafodotin during both phases of the treatment period plus 1 of 3 prophylactic ophthalmologic treatments (standard steroids [SS], standard steroids with vasoconstrictors and cold compress [SS/VC], and enhanced steroids with vasoconstrictors and cooling compress [ES/VC]).",null,"Phase 3b Study for Management of Ocular Side Effects in Subjects With EGFR-amplified Glioblastoma Receiving Depatuxizumab Mafodotin (ABT-414)","M16-534","Glioblastoma Multiforme","Glioblastoma","Oncology Solid Tumor","Oncology","Experimental","Arm B: Standard Steroids + Vasoconstrictor + Cold Compress|Arm A: Standard Steroid (SS)|Arm C: Enhanced Steroids+Vasoconstrictor+Cold Compress (ES/VC)","Arm B: Steroid eye drop plus vasoconstrictor eye drop and cold compress plus depatuxizumab mafodotin during both the chemoradiation therapy (RT and TMZ) and the adjuvant therapy [TMZ] periods of this study.|Arm A: Steroid Eye Drops plus depatuxizumab mafodotin during both the chemoradiation therapy (radiation [RT] and temozolomide [TMZ]) and the adjuvant therapy [TMZ] periods of this study.|Arm C: Steroid Eye Drop plus ophthalmic steroid ointment plus vasoconstrictor eye drop and cold compresses plus depatuxizumab mafodotin during both the chemoradiation therapy (RT and TMZ) and the adjuvant therapy [TMZ] periods of this study.","Drug","Steroid eye drop|Radiation: Radiation|Temozolomide|depatuxizumab mafodotin|Vasoconstrictor eye drop|Ophthalmic steroid ointment","solution, eye drop|radiation|oral|infusion|ointment","ABT-414\ncold compresscold compress|ABT-414","Arm B: Standard Steroids + Vasoconstrictor + Cold Compress|Arm A: Standard Steroid (SS)|Arm C: Enhanced Steroids+Vasoconstrictor+Cold Compress (ES/VC)","\n\n * Newly diagnosed glioblastoma (GBM) histologically proven, World Health Organization (WHO) grade IV GBM or WHO grade IV gliosarcoma.\n * Tumors must demonstrate epidermal growth factor receptor (EGFR) amplification.\n * Tumors must be supratentorial in location.\n * Participant must have recovered from the effects of surgery, postoperative infection, and other complications; has no significant post-operative hemorrhage.\n * Participant has a Karnofsky performance status (KPS) of 70 or higher.\n * Participant has adequate bone marrow, renal, and hepatic function.\n * Electrocardiogram without evidence of acute cardiac ischemia <= 21 days prior to randomization.\n * Participant has a life expectancy of >= 3 months.\n\n","\n\n * Participants with newly diagnosed GBM: has received prior chemotherapy or radiotherapy for cancer of the head and neck region; has received prior treatment with Gliadel wafers or any other intratumoral or intracavitary treatment.\n * Participant has hypersensitivity to any component of TMZ or dacarbazine.\n * Participant has received anti-cancer therapy (including chemotherapy, immunotherapy, radiotherapy, hormonal, biologic, or any investigational therapy) within 5 years of Study Day 1.\n * Participant has clinically significant uncontrolled condition(s) as described in the protocol.\n * Participant has any medical condition which in the opinion of the investigator places the participant at an unacceptably high risk for toxicities.\n * Participant has had another active malignancy within the past 3 years except for any cancer considered cured or non-melanoma carcinoma of the skin.\n * Participant has a history of herpetic keratitis.\n * Participant is not suitable for receiving ocular steroids with conditions as described in the protocol.\n * Participant has had laser-assisted in situ keratomileusis (LASIK) procedure within the last 1 year or cataract surgery within the last 3 months.\n * Participant has a visual condition that compromises the ability to accurately measure visual acuity or assess visual activities of daily living (vADLs).\n * Participant has hepatitis B virus or hepatitis C virus infection.\n * Participant not receiving treatment with highly active antiretroviral therapy (HAART) when positive for human immunodeficiency virus (HIV).","EGFR","epidermal growth factor receptor","Protein","Ovary, Breast, Lung","Actual","2018-02-05","Actual","Anticipated","2020-02-16","Anticipated","2019-05-01","2018-01-26","2018-01-26","2019-05-23","No","Glioblastoma Multiforme (GBM)\ncancer\nchemoradiation therapy\nepidermal growth factor receptor-amplified glioblastoma\nradiation\ntemozolomide","Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No","Yes\nAbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2017-003171-64","EudraCT Number","Participants who Require a Change in Ocular Side Effect (OSE) Management","Ocular Side Effect (OSE) management is defined as a participant with >= 3-line loss (+ 0.3 on LogMAR scale or equivalent) of best corrected visual acuity from baseline (with prescription at baseline for those using corrective lens), or >= Grade 3 OSE severity on the Corneal Epithelial Adverse Event","CEAE scale.","Cumulative Dose of Depatuxizumab Mafodotin|Change from Baseline In Logarithm of the Minimum Angle of Resolution (LogMAR) Scale after Bandage Contact Lenses (BCL) Intervention|Time to OSE Symptom Resolution after Drug Discontinuation (reversibility)|Time to BCL Intervention|Participants that recover to <3-line decline from Baseline (<= +0.3 LogMAR) in visual acuity after BCL Intervention|Corneal Epithelial Adverse Event (CEAE) Grade|Time to Re-initiation of Depatuxizumab Mafodotin after Dose Interruption|Participants with Depatuxizumab Mafodotin Dose Interruptions due to OSEs|Participants with Depatuxizumab Mafodotin Dose Reductions due to OSEs|Maximum Change from Baseline on LogMAR Scale","Cumulative dose of depatuxizumab mafodotin administered (mg/kg).|Change on LogMAR Scale from last assessment prior to BCL intervention to 2 weeks after BCL intervention. The LogMAR scale measures visual acuity on a continuous scale, with a LogMAR value of 0 equivalent to 20/20 visual acuity. Normal vision is considered to be from -0.2 - 0.1; higher values indicate visual impairment.|Time from discontinuation of depatuxizumab mafodotin to OSE symptom resolution (reversibility).|Time to initiation of bandage contact lenses (BCL) intervention.|Recovery is defined as return to <3-line decline from baseline (<= +0.3 LogMAR) in visual acuity after BCL intervention.|The corneal epithelial adverse event (CEAE) rating scale is designed to record symptoms associated with corneal epitheliopathy caused by antibody-drug conjugates and to grade the severity of findings. The overall CEAE grade is measured on a scale of 0 to 5, with higher values being more severe, reflecting the impact of corneal abnormalities on visual activities of daily living (ADLs). Additional detailed information is collected for specific domains that are commonly affected, with the following ranges (each in order of increasing severity): ocular discomfort (0 - 4), photophobia (0 - 3), and reading (1 - 3).|Time from dose interruption until re-initiation or permanent discontinuation of depatuxizumab mafodotin.|Participants with dose interruptions of depatuxizumab mafodotin due to ocular side effects (OSEs).|Dose reductions of depatuxizumab mafodotin initiated due to OSEs.|The Logarithm of the Minimum Angle of Resolution (LogMAR) scale measures visual acuity on a continuous scale, with a LogMAR value of 0 equivalent to 20/20 visual acuity. Normal vision is considered to be from -0.2 - 0.1; higher values indicate visual impairment.","Up to approximately 18 weeks after initial dose of depatuxizumab mafodotin|Up to approximately 3 years after initial dose of depatuxizumab mafodotin",{"$nulls":3},"Saint Leonards, New South Wales, Australia, 2065 Calvary Mater Newcastle /Id# 169672Waratah, New South Wales, Australia, 2298|Herston, Queensland, Australia, 4029|Heidelberg, Victoria, Australia, 3084|Paris, France, 75651|St Herblain Cedex, Loire-Atlantique, France, 44805|Marseille Cedex 05, Provence-Alpes-Cote-D Azur, France, 13385|Heidelberg, Baden-Wuerttemberg, Germany, 69120|Leipzig, Sachsen, Germany, 04103|Hamburg, Germany, 20246 Klinikum Univ Regensburg /Id# 169963Regensburg, Germany, 93042 Universitatsklinikum Tubingen /Id# 169965Tuebingen, Germany, 72076|Amsterdam, Netherlands, 1081 Hv Medisch Spectrum Twente /Id# 201603Enschede, Netherlands, 7511 Jx Universitair Medisch Centrum Utrecht /Id# 170149Utrecht, Netherlands, 3584 Cx|London, London, City Of, United Kingdom, Se1 9Rt|Birmingham, United Kingdom, B15 2Th Castle Hill Hospital /Id# 200662Cottingham, United Kingdom, Hu16 5Jq Western General Hospital /Id# 203040Edinburgh, United Kingdom, Eh4 2Xu Freeman Hospital /Id# 200653Newcastle Upon Tyne, United Kingdom, Ne7 7Dn|Los Angeles, California, United States, 90033|Tampa, Florida, United States, 33612|Chicago, Illinois, United States, 60611 Rush University Medical Center /Id# 171003Chicago, Illinois, United States, 60612 Northshore University Healthsystem - Skokie /Id# 164221Skokie, Illinois, United States, 60077 Cdh-Delnor Health System /Id# 169909Warrenville, Illinois, United States, 60555|New York, New York, United States, 10032-3725|Charlotte, North Carolina, United States, 28204|Houston, Texas, United States, 77030 Scott & White Mem Hosp & Clin /Id# 170792Temple, Texas, United States, 76508","California|Florida|Illinois|New York|North Carolina|Texas","Australia|France|Germany|Netherlands|United Kingdom|United States","New South Wales Royal North Shore Hospital /Id# 169673|Queensland Royal Brisbane And Women's Hospital /Id# 169674|Victoria Austin Hospital /Id# 169671|Hopital Pitie Salpetriere /Id# 209082|Loire-Atlantique Institut De Cancer De L'Ouest /Id# 209084|Provence-Alpes-Cote-D Azur Hopital De La Timone /Id# 209057|Baden-Wuerttemberg Universitaetsklinik Heidelberg /Id# 169970|Sachsen Universitaetsklinikum Leipzig /Id# 169969|Univ Klinik Eppendorf Hamburg /Id# 169971|Vrije Universiteit Medisch Centrum /Id# 170152|, London, City Of Guy's And St Thomas' Nhs Found /Id# 207752|Queen Elizabeth Hospital - Birmingham /Id# 200657|Usc /Id# 164235|Moffitt Cancer Center /Id# 164234|Northwestern Medical /Id# 164231|Columbia Univ Medical Center /Id# 164220|Levine Cancer Ins, Carolina Me /Id# 171271|Ut Health Science Ctr-Houston /Id# 164223",{"$nulls":3},"AbbVie Inc.","2019-05-23","2020-05-25T16:40:03.111","2020-05-26T17:10:42.972","NCT03419403"]
["5ecbf4e3feab101b15530a2c","NCT03419403","2019-09-12","AbbVie","ABBV","Active, not recruiting","UNITE Study: Understanding New Interventions With GBM ThErapy","Temozolomide|Vorsetuzumab mafodotin|Epinephrine","DNA Mtase Inhibitor|Tubulin Inhibitor|Mitosis Inhibitor|ADRB Agonist","Yes","['Vorsetuzumab mafodotin']","Unknown",null,"Phase 3",3,40,"Actual","2018-07-30","2020-02-17",{"$nulls":5},"This study will evaluate the effect of several ophthalmologic prophylactic treatment strategies for the management of ocular side effects (OSEs) in participants with epidermal growth factor receptor (EGFR)-amplified glioblastoma (GBM) who are being treated with depatuxizumab mafodotin (ABT-414). The study will include 2 phases during the treatment period: chemoradiation therapy (radiation plus temozolomide [RT/TMZ]) and adjuvant therapy (TMZ ). All participants will receive depatuxizumab mafodotin during both phases of the treatment period plus 1 of 3 prophylactic ophthalmologic treatments (standard steroids [SS], standard steroids with vasoconstrictors and cold compress [SS/VC], and enhanced steroids with vasoconstrictors and cooling compress [ES/VC]).",null,"Phase 3b Study for Management of Ocular Side Effects in Subjects With EGFR-amplified Glioblastoma Receiving Depatuxizumab Mafodotin (ABT-414)","M16-534","Glioblastoma Multiforme","Glioblastoma","Oncology Solid Tumor","Oncology","Experimental","Arm B: Standard Steroids + Vasoconstrictor + Cold Compress|Arm A: Standard Steroid (SS)|Arm C: Enhanced Steroids+Vasoconstrictor+Cold Compress (ES/VC)","Arm B: Steroid eye drop plus vasoconstrictor eye drop and cold compress plus depatuxizumab mafodotin during both the chemoradiation therapy (RT and TMZ) and the adjuvant therapy [TMZ] periods of this study.|Arm A: Steroid Eye Drops plus depatuxizumab mafodotin during both the chemoradiation therapy (radiation [RT] and temozolomide [TMZ]) and the adjuvant therapy [TMZ] periods of this study.|Arm C: Steroid Eye Drop plus ophthalmic steroid ointment plus vasoconstrictor eye drop and cold compresses plus depatuxizumab mafodotin during both the chemoradiation therapy (RT and TMZ) and the adjuvant therapy [TMZ] periods of this study.","Drug","Steroid eye drop|Radiation: Radiation|Temozolomide|depatuxizumab mafodotin|Vasoconstrictor eye drop|Ophthalmic steroid ointment","solution, eye drop|radiation|oral|infusion|ointment","ABT-414\ncold compresscold compress|ABT-414","Arm B: Standard Steroids + Vasoconstrictor + Cold Compress|Arm A: Standard Steroid (SS)|Arm C: Enhanced Steroids+Vasoconstrictor+Cold Compress (ES/VC)","\n\n * Newly diagnosed glioblastoma (GBM) histologically proven, World Health Organization (WHO) grade IV GBM or WHO grade IV gliosarcoma.\n * Tumors must demonstrate epidermal growth factor receptor (EGFR) amplification.\n * Tumors must be supratentorial in location.\n * Participant must have recovered from the effects of surgery, postoperative infection, and other complications; has no significant post-operative hemorrhage.\n * Participant has a Karnofsky performance status (KPS) of 70 or higher.\n * Participant has adequate bone marrow, renal, and hepatic function.\n * Electrocardiogram without evidence of acute cardiac ischemia <= 21 days prior to randomization.\n * Participant has a life expectancy of >= 3 months.\n\n","\n\n * Participants with newly diagnosed GBM: has received prior chemotherapy or radiotherapy for cancer of the head and neck region; has received prior treatment with Gliadel wafers or any other intratumoral or intracavitary treatment.\n * Participant has hypersensitivity to any component of TMZ or dacarbazine.\n * Participant has received anti-cancer therapy (including chemotherapy, immunotherapy, radiotherapy, hormonal, biologic, or any investigational therapy) within 5 years of Study Day 1.\n * Participant has clinically significant uncontrolled condition(s) as described in the protocol.\n * Participant has any medical condition which in the opinion of the investigator places the participant at an unacceptably high risk for toxicities.\n * Participant has had another active malignancy within the past 3 years except for any cancer considered cured or non-melanoma carcinoma of the skin.\n * Participant has a history of herpetic keratitis.\n * Participant is not suitable for receiving ocular steroids with conditions as described in the protocol.\n * Participant has had laser-assisted in situ keratomileusis (LASIK) procedure within the last 1 year or cataract surgery within the last 3 months.\n * Participant has a visual condition that compromises the ability to accurately measure visual acuity or assess visual activities of daily living (vADLs).\n * Participant has hepatitis B virus or hepatitis C virus infection.\n * Participant not receiving treatment with highly active antiretroviral therapy (HAART) when positive for human immunodeficiency virus (HIV).","EGFR","epidermal growth factor receptor","Protein","Ovary, Breast, Lung","Actual","2018-02-05","Actual","Anticipated","2020-07-16","Anticipated","2019-09-01","2018-01-26","2018-01-26","2019-09-10","No","Glioblastoma Multiforme (GBM)\ncancer\nchemoradiation therapy\nepidermal growth factor receptor-amplified glioblastoma\nradiation\ntemozolomide","Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No","Yes\nAbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2017-003171-64","EudraCT Number","Participants who Require a Change in Ocular Side Effect (OSE) Management","Ocular Side Effect (OSE) management is defined as a participant with >= 3-line loss (+ 0.3 on LogMAR scale or equivalent) of best corrected visual acuity from baseline (with prescription at baseline for those using corrective lens), or >= Grade 3 OSE severity on the Corneal Epithelial Adverse Event","CEAE scale.","Cumulative Dose of Depatuxizumab Mafodotin|Change from Baseline In Logarithm of the Minimum Angle of Resolution (LogMAR) Scale after Bandage Contact Lenses (BCL) Intervention|Time to OSE Symptom Resolution after Drug Discontinuation (reversibility)|Time to BCL Intervention|Participants that recover to <3-line decline from Baseline (<= +0.3 LogMAR) in visual acuity after BCL Intervention|Corneal Epithelial Adverse Event (CEAE) Grade|Time to Re-initiation of Depatuxizumab Mafodotin after Dose Interruption|Participants with Depatuxizumab Mafodotin Dose Interruptions due to OSEs|Participants with Depatuxizumab Mafodotin Dose Reductions due to OSEs|Maximum Change from Baseline on LogMAR Scale","Cumulative dose of depatuxizumab mafodotin administered (mg/kg).|Change on LogMAR Scale from last assessment prior to BCL intervention to 2 weeks after BCL intervention. The LogMAR scale measures visual acuity on a continuous scale, with a LogMAR value of 0 equivalent to 20/20 visual acuity. Normal vision is considered to be from -0.2 - 0.1; higher values indicate visual impairment.|Time from discontinuation of depatuxizumab mafodotin to OSE symptom resolution (reversibility).|Time to initiation of bandage contact lenses (BCL) intervention.|Recovery is defined as return to <3-line decline from baseline (<= +0.3 LogMAR) in visual acuity after BCL intervention.|The corneal epithelial adverse event (CEAE) rating scale is designed to record symptoms associated with corneal epitheliopathy caused by antibody-drug conjugates and to grade the severity of findings. The overall CEAE grade is measured on a scale of 0 to 5, with higher values being more severe, reflecting the impact of corneal abnormalities on visual activities of daily living (ADLs). Additional detailed information is collected for specific domains that are commonly affected, with the following ranges (each in order of increasing severity): ocular discomfort (0 - 4), photophobia (0 - 3), and reading (1 - 3).|Time from dose interruption until re-initiation or permanent discontinuation of depatuxizumab mafodotin.|Participants with dose interruptions of depatuxizumab mafodotin due to ocular side effects (OSEs).|Dose reductions of depatuxizumab mafodotin initiated due to OSEs.|The Logarithm of the Minimum Angle of Resolution (LogMAR) scale measures visual acuity on a continuous scale, with a LogMAR value of 0 equivalent to 20/20 visual acuity. Normal vision is considered to be from -0.2 - 0.1; higher values indicate visual impairment.","Up to approximately 18 weeks after initial dose of depatuxizumab mafodotin|Up to approximately 3 years after initial dose of depatuxizumab mafodotin",{"$nulls":3},"Saint Leonards, New South Wales, Australia, 2065 Calvary Mater Newcastle /Id# 169672Waratah, New South Wales, Australia, 2298|Herston, Queensland, Australia, 4029|Heidelberg, Victoria, Australia, 3084|Heidelberg, Baden-Wuerttemberg, Germany, 69120|Regensburg, Germany, 93042 Universitatsklinikum Tubingen /Id# 169965Tuebingen, Germany, 72076|Leipzig, Sachsen, Germany, 04103|Amsterdam, Netherlands, 1081 Hv Medisch Spectrum Twente /Id# 201603Enschede, Netherlands, 7511 Jx Universitair Medisch Centrum Utrecht /Id# 170149Utrecht, Netherlands, 3584 Cx|London, London, City Of, United Kingdom, Se1 9Rt|Birmingham, United Kingdom, B15 2Th Castle Hill Hospital /Id# 200662Cottingham, United Kingdom, Hu16 5Jq Western General Hospital /Id# 203040Edinburgh, United Kingdom, Eh4 2Xu|Los Angeles, California, United States, 90033|Tampa, Florida, United States, 33612-9416|Chicago, Illinois, United States, 60612 Northshore University Health System-Evanston /Id# 164221Evanston, Illinois, United States, 60201 Cdh-Delnor Health System /Id# 169909Warrenville, Illinois, United States, 60555|New York, New York, United States, 10032-3725|Charlotte, North Carolina, United States, 28204|Houston, Texas, United States, 77030 Scott & White Mem Hosp & Clin /Id# 170792Temple, Texas, United States, 76508","California|Florida|Illinois|New York|North Carolina|Texas","Australia|Germany|Netherlands|United Kingdom|United States","New South Wales Royal North Shore Hospital /Id# 169673|Queensland Royal Brisbane And Women's Hospital /Id# 169674|Victoria Austin Hospital /Id# 169671|Baden-Wuerttemberg Universitaetsklinik Heidelberg /Id# 169970|Klinikum Univ Regensburg /Id# 169963|Sachsen Universitaetsklinikum Leipzig /Id# 169969|Vrije Universiteit Medisch Centrum /Id# 170152|, London, City Of Guy's And St Thomas' Nhs Found /Id# 207752|Queen Elizabeth Hospital - Birmingham /Id# 200657|Usc /Id# 164235|Moffitt Cancer Center /Id# 164234|Rush University Medical Center /Id# 171003|Columbia Univ Medical Center /Id# 164220|Levine Cancer Ins, Carolina Me /Id# 171271|Ut Health Science Ctr-Houston /Id# 164223",{"$nulls":3},"AbbVie Inc.","2019-09-10","2020-05-25T16:40:03.213","2020-05-26T17:10:42.972","NCT03419403"]
["5ecbf4e3fe30261b1a0483fe","NCT03419403","2020-04-03","AbbVie","ABBV","Completed","UNITE Study: Understanding New Interventions With GBM ThErapy","Temozolomide|Vorsetuzumab mafodotin|Epinephrine","DNA Mtase Inhibitor|Tubulin Inhibitor|Mitosis Inhibitor|ADRB Agonist","Yes","['Vorsetuzumab mafodotin']","Unknown",null,"Phase 3",3,40,"Actual","2018-07-30","2019-09-05",{"$nulls":5},"This study will evaluate the effect of several ophthalmologic prophylactic treatment strategies for the management of ocular side effects (OSEs) in participants with epidermal growth factor receptor (EGFR)-amplified glioblastoma (GBM) who are being treated with depatuxizumab mafodotin (ABT-414). The study will include 2 phases during the treatment period: chemoradiation therapy (radiation plus temozolomide [RT/TMZ]) and adjuvant therapy (TMZ ). All participants will receive depatuxizumab mafodotin during both phases of the treatment period plus 1 of 3 prophylactic ophthalmologic treatments (standard steroids [SS], standard steroids with vasoconstrictors and cold compress [SS/VC], and enhanced steroids with vasoconstrictors and cooling compress [ES/VC]).",null,"Phase 3b Study for Management of Ocular Side Effects in Subjects With EGFR-amplified Glioblastoma Receiving Depatuxizumab Mafodotin (ABT-414)","M16-534","Glioblastoma Multiforme","Glioblastoma","Oncology Solid Tumor","Oncology","Experimental","Arm B: Standard Steroids + Vasoconstrictor + Cold Compress|Arm A: Standard Steroid (SS)|Arm C: Enhanced Steroids+Vasoconstrictor+Cold Compress (ES/VC)","Arm B: Steroid eye drop plus vasoconstrictor eye drop and cold compress plus depatuxizumab mafodotin during both the chemoradiation therapy (RT and TMZ) and the adjuvant therapy [TMZ] periods of this study.|Arm A: Steroid Eye Drops plus depatuxizumab mafodotin during both the chemoradiation therapy (radiation [RT] and temozolomide [TMZ]) and the adjuvant therapy [TMZ] periods of this study.|Arm C: Steroid Eye Drop plus ophthalmic steroid ointment plus vasoconstrictor eye drop and cold compresses plus depatuxizumab mafodotin during both the chemoradiation therapy (RT and TMZ) and the adjuvant therapy [TMZ] periods of this study.","Drug","Steroid eye drop|Radiation: Radiation|Temozolomide|depatuxizumab mafodotin|Vasoconstrictor eye drop|Ophthalmic steroid ointment","solution, eye drop|radiation|oral|infusion|ointment","ABT-414\ncold compresscold compress|ABT-414","Arm B: Standard Steroids + Vasoconstrictor + Cold Compress|Arm A: Standard Steroid (SS)|Arm C: Enhanced Steroids+Vasoconstrictor+Cold Compress (ES/VC)","\n\n * Newly diagnosed glioblastoma (GBM) histologically proven, World Health Organization (WHO) grade IV GBM or WHO grade IV gliosarcoma.\n * Tumors must demonstrate epidermal growth factor receptor (EGFR) amplification.\n * Tumors must be supratentorial in location.\n * Participant must have recovered from the effects of surgery, postoperative infection, and other complications; has no significant post-operative hemorrhage.\n * Participant has a Karnofsky performance status (KPS) of 70 or higher.\n * Participant has adequate bone marrow, renal, and hepatic function.\n * Electrocardiogram without evidence of acute cardiac ischemia <= 21 days prior to randomization.\n * Participant has a life expectancy of >= 3 months.\n\n","\n\n * Participants with newly diagnosed GBM: has received prior chemotherapy or radiotherapy for cancer of the head and neck region; has received prior treatment with Gliadel wafers or any other intratumoral or intracavitary treatment.\n * Participant has hypersensitivity to any component of TMZ or dacarbazine.\n * Participant has received anti-cancer therapy (including chemotherapy, immunotherapy, radiotherapy, hormonal, biologic, or any investigational therapy) within 5 years of Study Day 1.\n * Participant has clinically significant uncontrolled condition(s) as described in the protocol.\n * Participant has any medical condition which in the opinion of the investigator places the participant at an unacceptably high risk for toxicities.\n * Participant has had another active malignancy within the past 3 years except for any cancer considered cured or non-melanoma carcinoma of the skin.\n * Participant has a history of herpetic keratitis.\n * Participant is not suitable for receiving ocular steroids with conditions as described in the protocol.\n * Participant has had laser-assisted in situ keratomileusis (LASIK) procedure within the last 1 year or cataract surgery within the last 3 months.\n * Participant has a visual condition that compromises the ability to accurately measure visual acuity or assess visual activities of daily living (vADLs).\n * Participant has hepatitis B virus or hepatitis C virus infection.\n * Participant not receiving treatment with highly active antiretroviral therapy (HAART) when positive for human immunodeficiency virus (HIV).","EGFR","epidermal growth factor receptor","Protein","Ovary, Breast, Lung","Actual","2018-02-05","Actual","Actual","2020-03-03","Actual","2020-04-01","2018-01-26","2018-01-26","2020-04-02","No","Glioblastoma Multiforme (GBM)\ncancer\nchemoradiation therapy\nepidermal growth factor receptor-amplified glioblastoma\nradiation\ntemozolomide","Interventional","Treatment","Parallel Assignment","None (Open Label)","Randomized","18 Years",null,"All",null,"No","Yes\nAbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.",{"$nulls":3},"Yes","No",{"$nulls":4},"No",{"$nulls":12},"2017-003171-64","EudraCT Number","Participants who Require a Change in Ocular Side Effect (OSE) Management","Ocular Side Effect (OSE) management is defined as a participant with >= 3-line loss (+ 0.3 on LogMAR scale or equivalent) of best corrected visual acuity from baseline (with prescription at baseline for those using corrective lens), or >= Grade 3 OSE severity on the Corneal Epithelial Adverse Event","CEAE scale.","Cumulative Dose of Depatuxizumab Mafodotin|Change from Baseline In Logarithm of the Minimum Angle of Resolution (LogMAR) Scale after Bandage Contact Lenses (BCL) Intervention|Time to OSE Symptom Resolution after Drug Discontinuation (reversibility)|Time to BCL Intervention|Participants that recover to <3-line decline from Baseline (<= +0.3 LogMAR) in visual acuity after BCL Intervention|Corneal Epithelial Adverse Event (CEAE) Grade|Time to Re-initiation of Depatuxizumab Mafodotin after Dose Interruption|Participants with Depatuxizumab Mafodotin Dose Interruptions due to OSEs|Participants with Depatuxizumab Mafodotin Dose Reductions due to OSEs|Maximum Change from Baseline on LogMAR Scale","Cumulative dose of depatuxizumab mafodotin administered (mg/kg).|Change on LogMAR Scale from last assessment prior to BCL intervention to 2 weeks after BCL intervention. The LogMAR scale measures visual acuity on a continuous scale, with a LogMAR value of 0 equivalent to 20/20 visual acuity. Normal vision is considered to be from -0.2 - 0.1; higher values indicate visual impairment.|Time from discontinuation of depatuxizumab mafodotin to OSE symptom resolution (reversibility).|Time to initiation of bandage contact lenses (BCL) intervention.|Recovery is defined as return to <3-line decline from baseline (<= +0.3 LogMAR) in visual acuity after BCL intervention.|The corneal epithelial adverse event (CEAE) rating scale is designed to record symptoms associated with corneal epitheliopathy caused by antibody-drug conjugates and to grade the severity of findings. The overall CEAE grade is measured on a scale of 0 to 5, with higher values being more severe, reflecting the impact of corneal abnormalities on visual activities of daily living (ADLs). Additional detailed information is collected for specific domains that are commonly affected, with the following ranges (each in order of increasing severity): ocular discomfort (0 - 4), photophobia (0 - 3), and reading (1 - 3).|Time from dose interruption until re-initiation or permanent discontinuation of depatuxizumab mafodotin.|Participants with dose interruptions of depatuxizumab mafodotin due to ocular side effects (OSEs).|Dose reductions of depatuxizumab mafodotin initiated due to OSEs.|The Logarithm of the Minimum Angle of Resolution (LogMAR) scale measures visual acuity on a continuous scale, with a LogMAR value of 0 equivalent to 20/20 visual acuity. Normal vision is considered to be from -0.2 - 0.1; higher values indicate visual impairment.","Up to approximately 18 weeks after initial dose of depatuxizumab mafodotin|Up to approximately 3 years after initial dose of depatuxizumab mafodotin",{"$nulls":3},"Saint Leonards, New South Wales, Australia, 2065 Calvary Mater Newcastle /Id# 169672Waratah, New South Wales, Australia, 2298|Herston, Queensland, Australia, 4029|Heidelberg, Victoria, Australia, 3084|Heidelberg, Baden-Wuerttemberg, Germany, 69120|Regensburg, Germany, 93042 Universitatsklinikum Tubingen /Id# 169965Tuebingen, Germany, 72076|Leipzig, Sachsen, Germany, 04103|Amsterdam, Netherlands, 1081 Hv Universitair Medisch Centrum Utrecht /Id# 170149Utrecht, Netherlands, 3584 Cx|London, London, City Of, United Kingdom, Se1 9Rt|Birmingham, United Kingdom, B15 2Th Castle Hill Hospital /Id# 200662Cottingham, United Kingdom, Hu16 5Jq Western General Hospital /Id# 203040Edinburgh, United Kingdom, Eh4 2Xu|Los Angeles, California, United States, 90033|Tampa, Florida, United States, 33612-9416|Chicago, Illinois, United States, 60612 Northshore University Health System-Evanston /Id# 164221Evanston, Illinois, United States, 60201 Cdh-Delnor Health System /Id# 169909Warrenville, Illinois, United States, 60555|New York, New York, United States, 10032-3729|Charlotte, North Carolina, United States, 28204|Houston, Texas, United States, 77030 Baylor Scott & White Medical Center- Temple /Id# 170792Temple, Texas, United States, 76508-0001","California|Florida|Illinois|New York|North Carolina|Texas","Australia|Germany|Netherlands|United Kingdom|United States","New South Wales Royal North Shore Hospital /Id# 169673|Queensland Royal Brisbane And Women's Hospital /Id# 169674|Victoria Austin Hospital /Id# 169671|Baden-Wuerttemberg Universitaetsklinik Heidelberg /Id# 169970|Klinikum Univ. Regensburg /Id# 169963|Sachsen Universitaetsklinikum Leipzig /Id# 169969|Vrije Universiteit Medisch Centrum /Id# 170152|, London, City Of Guy's And St Thomas' Nhs Found /Id# 207752|Queen Elizabeth Hospital - Birmingham /Id# 200657|Usc /Id# 164235|Moffitt Cancer Center /Id# 164234|Rush University Medical Center /Id# 171003|Columbia University Medical Center /Id# 164220|Levine Cancer Ins, Carolina Me /Id# 171271|Ut Health Science Ctr-Houston /Id# 164223",{"$nulls":3},"AbbVie Inc.","2020-04-02","2020-05-25T16:40:03.883","2020-05-26T17:10:42.972","NCT03419403"]
["5ecbf4e5307e3d1b1f8d9e93","NCT03419559","2018-02-05","Iovance Biotherapeutics","IOVA","Not yet recruiting","Study of Autologous Tumor Infiltrating Lymphocytes (LN-145) Alone and In Combo With Durvalumab in Non-Small Cell Lung Cancer","Durvalumab|Ln-145","PDL-1 Inhibitor","Yes","['Ln-145']","No",null,"Phase 2",2,24,"Anticipated","2018-03-01","2021-12-01","RR","Response Rate",{"$nulls":3},"This study is a Phase 2, open-label, 2-cohort, multicenter study evaluating adoptive cell therapy (ACT) with autologous TIL therapy (LN-145) alone, (Cohort 1), or in combination with durvalumab (anti-programmed cell death ligand 1 [PD-L1] monoclonal antibody [mAb]) (Cohort 2).","LN-145 is an adoptive cell transfer therapy that utilizes an autologous TIL manufacturing process, as originally developed by the NCI. The cell transfer therapy used in this study involves patients receiving a nonmyeloablative (NMA) lymphocyte depleting preparative regimen, followed by infusion of autologous TIL followed by the administration of up to 6 doses of IL-2. Patients in Cohort 2 will also receive durvalumab Q4Weeks until progression or unacceptable toxicity.","A Phase 2 Study to Assess the Efficacy and Safety of Autologous Tumor Infiltrating Lymphocytes (LN-145) Alone and In Combination With Anti-PD-L1 Inhibitor Durvalumab (MEDI4736) in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)","IOV-LUN-201","Non Small Cell Lung Cancer","Lung Cancer|Small Cell Lung Cancer|Non-Small-Cell Lung Cancer","Oncology Solid Tumor","Oncology","Experimental|Active Comparator","Cohort 1 LN-145 alone|Cohort 2 LN-145 in combination with durvalumab","After nonmyeloablative (NMA) lymphodepletion, patients are infused with their autologous (LN-145) followed by IL-2 administration|After nonmyeloablative (NMA) lymphodepletion, patients are infused with their autologous (LN-145) followed by IL-2 administration. Patients in cohort 2 will also receive durvalumab Q4Weeks","Biological","LN-145","adoptive cell therapy (ACT) with autologous TIL therapy","Durvalumab (MEDI4736)","Cohort 1 LN-145 alone|Cohort 2 LN-145 in combination with durvalumab","\n\n * Confirmed diagnosis of Stage III or Stage IV NSCLC and have received â‰¥ 1 line of prior systemic therapy in the locally advanced or metastatic setting\n * Have at least 1 resectable lesion to generate TIL\n * Measurable disease as defined by Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)\n * Male or female, â‰¥ 18 years of age\n * Body weight > 30 kg\n * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and estimated life expectancy of â‰¥ 3 months\n * Adequate bone marrow function at screening\n * Adequate organ function at screening\n * If the patient is of childbearing potential or their partner(s) is of childbearing potential, they must agree to use highly effective method of contraception while on study and for 6 months after receiving all protocol-related therapy.\n\n","\n\n * Must not have a history of other malignancies, except for adequately treated nonmelanoma skin cancer, curatively treated in-situ cancer of the cervix, curatively-treated thyroid cancer, or other solid tumors curatively treated with no evidence of disease for â‰¥ 3 years\n * Patients may not have received prior cell therapy\n * Patients may not have received prior anti PD-1 or anti PD-L1 inhibitors\n * Active or prior documented autoimmune or inflammatory disorders\n * History of primary immunodeficiency, history of allogeneic organ transplant that requires therapeutic immunosuppression\n * Received live or attenuated vaccination within 28 days prior to the start of NMA-LD\n * History of hypersensitivity to cyclophosphamide, fludarabine, dimethyl sulfoxide (DMSO) or IL-2\n * Known allergic reaction to antibiotics of the aminoglycoside group (ie, streptomycin, gentamicin)\n * Mean QT interval â‰¥ 470 msec\n * Decreased cardiac function as evidenced by a left ventricular ejection fraction of < 45%\n * Uncontrolled intercurrent illness\n * Patients who have obstructive or restrictive pulmonary disease and have a documented FEV1 (forced expiratory volume in 1 second) of â‰¤ 60%\n * Active central nervous system metastases and/or leptomeningeal disease\n * Current or prior use of immunosuppressive medication within 28 days before the first study treatment",{"$nulls":4},"Actual","2018-02-05","Actual","Anticipated","2022-12-01","Anticipated","2018-01-01","2018-01-14","2018-01-26","2018-01-26","Yes","LN-145\nCell Therapy\nAutologous Adoptive Cell Transfer\nCellular Immuno-therapy\nTIL\nIL-2\nDurvalumab","Interventional","Treatment","Sequential Assignment","None (Open Label)","Non-Randomized","18 Years",null,"All",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":19},"Objective Response Rate|â‰¥ Grade 3 adverse event (AE)","To evaluate efficacy using the objective response rate (ORR|To evaluate the safety as measured by any â‰¥ Grade 3 adverse event (AE) rate","A maximum of 24 months","Duration of Response|Progression Free Survival|Overall Survival","To further evaluate efficacy such as the duration of response (DOR)|To further evaluate efficacy such as progression free survival (PFS) (PFS)|To further evaluate efficacy such as overall survival (OS)","A maximum of 24 months|A minimum of 3 years","clinical.inquiries@iovance.com","Iovance Biotherapeutics Clinical Inquiries","650-260-7120",{"$nulls":4},"clinical.inquiries@iovance.com","Iovance Biotherapeutics Clinical Inquiries","866-565-4410","Iovance Medical Monitor","2018-01-26","2020-05-25T16:40:05.364","2020-05-26T17:10:42.972","NCT03419559"]
["5ecbf4e5e2561b1b11905efd","NCT03419559","2018-02-05","Iovance Biotherapeutics","IOVA","Not yet recruiting","Study of Autologous Tumor Infiltrating Lymphocytes (LN-145) Alone and In Combo With Durvalumab in Non-Small Cell Lung Cancer","Ln-145|Durvalumab","PDL-1 Inhibitor","Yes","['Ln-145']","No",null,"Phase 2",2,24,"Anticipated","2018-03-01","2021-12-01","RR","Response Rate",{"$nulls":3},"This study is a Phase 2, open-label, 2-cohort, multicenter study evaluating adoptive cell therapy (ACT) with autologous TIL therapy (LN-145) alone, (Cohort 1), or in combination with durvalumab (anti-programmed cell death ligand 1 [PD-L1] monoclonal antibody [mAb]) (Cohort 2).","LN-145 is an adoptive cell transfer therapy that utilizes an autologous TIL manufacturing process, as originally developed by the NCI. The cell transfer therapy used in this study involves patients receiving a nonmyeloablative (NMA) lymphocyte depleting preparative regimen, followed by infusion of autologous TIL followed by the administration of up to 6 doses of IL-2. Patients in Cohort 2 will also receive durvalumab Q4Weeks until progression or unacceptable toxicity.","A Phase 2 Study to Assess the Efficacy and Safety of Autologous Tumor Infiltrating Lymphocytes (LN-145) Alone and In Combination With Anti-PD-L1 Inhibitor Durvalumab (MEDI4736) in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)","IOV-LUN-201","Non Small Cell Lung Cancer","Lung Cancer|Small Cell Lung Cancer|Non-Small-Cell Lung Cancer","Oncology Solid Tumor","Oncology","Experimental|Active Comparator","Cohort 1 LN-145 alone|Cohort 2 LN-145 in combination with durvalumab","After nonmyeloablative (NMA) lymphodepletion, patients are infused with their autologous (LN-145) followed by IL-2 administration|After nonmyeloablative (NMA) lymphodepletion, patients are infused with their autologous (LN-145) followed by IL-2 administration. Patients in cohort 2 will also receive durvalumab Q4Weeks","Biological|Drug","LN-145|Durvalumab","adoptive cell therapy (ACT) with autologous TIL therapy|PD-L1 antagonist monoclonal antibody","MEDI4736","Cohort 1 LN-145 alone|Cohort 2 LN-145 in combination with durvalumab","\n\n * Confirmed diagnosis of Stage III or Stage IV NSCLC and have received â‰¥ 1 line of prior systemic therapy in the locally advanced or metastatic setting\n * Have at least 1 resectable lesion to generate TIL\n * Measurable disease as defined by Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)\n * Male or female, â‰¥ 18 years of age\n * Body weight > 30 kg\n * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and estimated life expectancy of â‰¥ 3 months\n * Adequate bone marrow function at screening\n * Adequate organ function at screening\n * If the patient is of childbearing potential or their partner(s) is of childbearing potential, they must agree to use highly effective method of contraception while on study and for 6 months after receiving all protocol-related therapy.\n\n","\n\n * Must not have a history of other malignancies, except for adequately treated nonmelanoma skin cancer, curatively treated in-situ cancer of the cervix, curatively-treated thyroid cancer, or other solid tumors curatively treated with no evidence of disease for â‰¥ 3 years\n * Patients may not have received prior cell therapy\n * Patients may not have received prior anti PD-1 or anti PD-L1 inhibitors\n * Active or prior documented autoimmune or inflammatory disorders\n * History of primary immunodeficiency, history of allogeneic organ transplant that requires therapeutic immunosuppression\n * Received live or attenuated vaccination within 28 days prior to the start of NMA-LD\n * History of hypersensitivity to cyclophosphamide, fludarabine, dimethyl sulfoxide (DMSO) or IL-2\n * Known allergic reaction to antibiotics of the aminoglycoside group (ie, streptomycin, gentamicin)\n * Mean QT interval â‰¥ 470 msec\n * Decreased cardiac function as evidenced by a left ventricular ejection fraction of < 45%\n * Uncontrolled intercurrent illness\n * Patients who have obstructive or restrictive pulmonary disease and have a documented FEV1 (forced expiratory volume in 1 second) of â‰¤ 60%\n * Active central nervous system metastases and/or leptomeningeal disease\n * Current or prior use of immunosuppressive medication within 28 days before the first study treatment",{"$nulls":4},"Actual","2018-02-05","Actual","Anticipated","2022-12-01","Anticipated","2018-01-01","2018-01-14","2018-01-26","2018-02-01","Yes","LN-145\nCell Therapy\nAutologous Adoptive Cell Transfer\nCellular Immuno-therapy\nTIL\nIL-2\nDurvalumab","Interventional","Treatment","Sequential Assignment","None (Open Label)","Non-Randomized","18 Years",null,"All",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":19},"Objective Response Rate|â‰¥ Grade 3 adverse event (AE)","To evaluate efficacy using the objective response rate (ORR|To evaluate the safety as measured by any â‰¥ Grade 3 adverse event (AE) rate","A maximum of 24 months","Duration of Response|Progression Free Survival|Overall Survival","To further evaluate efficacy such as the duration of response (DOR)|To further evaluate efficacy such as progression free survival (PFS) (PFS)|To further evaluate efficacy such as overall survival (OS)","A maximum of 24 months|A minimum of 3 years","clinical.inquiries@iovance.com","Iovance Biotherapeutics Clinical Inquiries","650-260-7120",{"$nulls":4},"clinical.inquiries@iovance.com","Iovance Biotherapeutics Clinical Inquiries","866-565-4410","Iovance Medical Monitor","2018-02-01","2020-05-25T16:40:05.401","2020-05-26T17:10:42.972","NCT03419559"]
["5ecbf4e5307e3d1b1f8d9e94","NCT03419559","2018-02-12","Iovance Biotherapeutics","IOVA","Not yet recruiting","Study of Autologous Tumor Infiltrating Lymphocytes (LN-145) Alone and In Combo With Durvalumab in Non-Small Cell Lung Cancer","Ln-145|Durvalumab","PDL-1 Inhibitor","Yes","['Ln-145']","No",null,"Phase 2",2,24,"Anticipated","2018-03-01","2021-12-01","RR","Response Rate",{"$nulls":3},"This study is a Phase 2, open-label, 2-cohort, multicenter study evaluating adoptive cell therapy (ACT) with autologous TIL therapy (LN-145) alone, (Cohort 1), or in combination with durvalumab (anti-programmed cell death ligand 1 [PD-L1] monoclonal antibody [mAb]) (Cohort 2).","LN-145 is an adoptive cell transfer therapy that utilizes an autologous TIL manufacturing process, as originally developed by the NCI. The cell transfer therapy used in this study involves patients receiving a nonmyeloablative (NMA) lymphocyte depleting preparative regimen, followed by infusion of autologous TIL followed by the administration of up to 6 doses of IL-2. Patients in Cohort 2 will also receive durvalumab Q4Weeks until progression or unacceptable toxicity.","A Phase 2 Study to Assess the Efficacy and Safety of Autologous Tumor Infiltrating Lymphocytes (LN-145) Alone and In Combination With Anti-PD-L1 Inhibitor Durvalumab (MEDI4736) in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)","IOV-LUN-201","Non Small Cell Lung Cancer","Lung Cancer|Small Cell Lung Cancer|Non-Small-Cell Lung Cancer","Oncology Solid Tumor","Oncology","Experimental|Active Comparator","Cohort 1 LN-145 alone|Cohort 2 LN-145 in combination with durvalumab","After nonmyeloablative (NMA) lymphodepletion, patients are infused with their autologous (LN-145) followed by IL-2 administration|After nonmyeloablative (NMA) lymphodepletion, patients are infused with their autologous (LN-145) followed by IL-2 administration. Patients in cohort 2 will also receive durvalumab Q4Weeks","Biological|Drug","LN-145|Durvalumab","adoptive cell therapy (ACT) with autologous TIL therapy|PD-L1 antagonist monoclonal antibody","MEDI4736","Cohort 1 LN-145 alone|Cohort 2 LN-145 in combination with durvalumab","\n\n * Confirmed diagnosis of Stage III or Stage IV NSCLC and have received â‰¥ 1 line of prior systemic therapy in the locally advanced or metastatic setting\n * Have at least 1 resectable lesion to generate TIL\n * Measurable disease as defined by Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)\n * Male or female, â‰¥ 18 years of age\n * Body weight > 30 kg\n * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and estimated life expectancy of â‰¥ 3 months\n * Adequate bone marrow function at screening\n * Adequate organ function at screening\n * If the patient is of childbearing potential or their partner(s) is of childbearing potential, they must agree to use highly effective method of contraception while on study and for 6 months after receiving all protocol-related therapy.\n\n","\n\n * Must not have a history of other malignancies, except for adequately treated nonmelanoma skin cancer, curatively treated in-situ cancer of the cervix, curatively-treated thyroid cancer, or other solid tumors curatively treated with no evidence of disease for â‰¥ 3 years\n * Patients may not have received prior cell therapy\n * Patients may not have received prior anti PD-1 or anti PD-L1 inhibitors\n * Active or prior documented autoimmune or inflammatory disorders\n * History of primary immunodeficiency, history of allogeneic organ transplant that requires therapeutic immunosuppression\n * Received live or attenuated vaccination within 28 days prior to the start of NMA-LD\n * History of hypersensitivity to cyclophosphamide, fludarabine, dimethyl sulfoxide (DMSO) or IL-2\n * Known allergic reaction to antibiotics of the aminoglycoside group (ie, streptomycin, gentamicin)\n * Mean QT interval â‰¥ 470 msec\n * Decreased cardiac function as evidenced by a left ventricular ejection fraction of < 45%\n * Uncontrolled intercurrent illness\n * Patients who have obstructive or restrictive pulmonary disease and have a documented FEV1 (forced expiratory volume in 1 second) of â‰¤ 60%\n * Active central nervous system metastases and/or leptomeningeal disease\n * Current or prior use of immunosuppressive medication within 28 days before the first study treatment",{"$nulls":4},"Actual","2018-02-05","Actual","Anticipated","2022-12-01","Anticipated","2018-01-01","2018-01-14","2018-01-26","2018-02-08","Yes","LN-145\nCell Therapy\nAutologous Adoptive Cell Transfer\nCellular Immuno-therapy\nTIL\nIL-2\nDurvalumab","Interventional","Treatment","Sequential Assignment","None (Open Label)","Non-Randomized","18 Years",null,"All",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":19},"Objective Response Rate|â‰¥ Grade 3 adverse event (AE)","To evaluate efficacy using the objective response rate (ORR|To evaluate the safety as measured by any â‰¥ Grade 3 adverse event (AE) rate","A maximum of 24 months","Duration of Response|Progression Free Survival|Overall Survival","To further evaluate efficacy such as the duration of response (DOR)|To further evaluate efficacy such as progression free survival (PFS) (PFS)|To further evaluate efficacy such as overall survival (OS)","A maximum of 24 months|A minimum of 3 years","clinical.inquiries@iovance.com","Iovance Biotherapeutics Clinical Inquiries","650-260-7120",{"$nulls":4},"clinical.inquiries@iovance.com","Iovance Biotherapeutics Clinical Inquiries","866-565-4410","Iovance Medical Monitor","2018-02-08","2020-05-25T16:40:05.556","2020-05-26T17:10:42.972","NCT03419559"]
["5ecbf4e611702c1b1b916c10","NCT03419559","2018-03-02","Iovance Biotherapeutics","IOVA","Recruiting","Study of Autologous Tumor Infiltrating Lymphocytes (LN-145) Alone and In Combo With Durvalumab in Non-Small Cell Lung Cancer","Ln-145|Durvalumab","PDL-1 Inhibitor","Yes","['Ln-145']","No",null,"Phase 2",2,24,"Anticipated","2018-02-28","2021-12-01","RR","Response Rate",{"$nulls":3},"This study is a Phase 2, open-label, 2-cohort, multicenter study evaluating adoptive cell therapy (ACT) with autologous TIL therapy (LN-145) alone, (Cohort 1), or in combination with durvalumab (anti-programmed cell death ligand 1 [PD-L1] monoclonal antibody [mAb]) (Cohort 2).","LN-145 is an adoptive cell transfer therapy that utilizes an autologous TIL manufacturing process, as originally developed by the NCI. The cell transfer therapy used in this study involves patients receiving a nonmyeloablative (NMA) lymphocyte depleting preparative regimen, followed by infusion of autologous TIL followed by the administration of up to 6 doses of IL-2. Patients in Cohort 2 will also receive durvalumab Q4Weeks until progression or unacceptable toxicity.","A Phase 2 Study to Assess the Efficacy and Safety of Autologous Tumor Infiltrating Lymphocytes (LN-145) Alone and In Combination With Anti-PD-L1 Inhibitor Durvalumab (MEDI4736) in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)","IOV-LUN-201","Non Small Cell Lung Cancer","Lung Cancer|Small Cell Lung Cancer|Non-Small-Cell Lung Cancer","Oncology Solid Tumor","Oncology","Experimental|Active Comparator","Cohort 1 LN-145 alone|Cohort 2 LN-145 in combination with durvalumab","After nonmyeloablative (NMA) lymphodepletion, patients are infused with their autologous (LN-145) followed by IL-2 administration|After nonmyeloablative (NMA) lymphodepletion, patients are infused with their autologous (LN-145) followed by IL-2 administration. Patients in cohort 2 will also receive durvalumab Q4Weeks","Biological|Drug","LN-145|Durvalumab","adoptive cell therapy (ACT) with autologous TIL therapy|PD-L1 antagonist monoclonal antibody","MEDI4736","Cohort 1 LN-145 alone|Cohort 2 LN-145 in combination with durvalumab","\n\n * Confirmed diagnosis of Stage III or Stage IV NSCLC and have received â‰¥ 1 line of prior systemic therapy in the locally advanced or metastatic setting\n * Have at least 1 resectable lesion to generate TIL\n * Measurable disease as defined by Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)\n * Male or female, â‰¥ 18 years of age\n * Body weight > 30 kg\n * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and estimated life expectancy of â‰¥ 3 months\n * Adequate bone marrow function at screening\n * Adequate organ function at screening\n * If the patient is of childbearing potential or their partner(s) is of childbearing potential, they must agree to use highly effective method of contraception while on study and for 6 months after receiving all protocol-related therapy.\n\n","\n\n * Must not have a history of other malignancies, except for adequately treated nonmelanoma skin cancer, curatively treated in-situ cancer of the cervix, curatively-treated thyroid cancer, or other solid tumors curatively treated with no evidence of disease for â‰¥ 3 years\n * Patients may not have received prior cell therapy\n * Patients may not have received prior anti PD-1 or anti PD-L1 inhibitors\n * Active or prior documented autoimmune or inflammatory disorders\n * History of primary immunodeficiency, history of allogeneic organ transplant that requires therapeutic immunosuppression\n * Received live or attenuated vaccination within 28 days prior to the start of NMA-LD\n * History of hypersensitivity to cyclophosphamide, fludarabine, dimethyl sulfoxide (DMSO) or IL-2\n * Known allergic reaction to antibiotics of the aminoglycoside group (ie, streptomycin, gentamicin)\n * Mean QT interval â‰¥ 470 msec\n * Decreased cardiac function as evidenced by a left ventricular ejection fraction of < 45%\n * Uncontrolled intercurrent illness\n * Patients who have obstructive or restrictive pulmonary disease and have a documented FEV1 (forced expiratory volume in 1 second) of â‰¤ 60%\n * Active central nervous system metastases and/or leptomeningeal disease\n * Current or prior use of immunosuppressive medication within 28 days before the first study treatment",{"$nulls":4},"Actual","2018-02-05","Actual","Anticipated","2022-12-01","Anticipated","2018-03-01","2018-01-14","2018-01-26","2018-03-01","Yes","LN-145\nCell Therapy\nAutologous Adoptive Cell Transfer\nCellular Immuno-therapy\nTIL\nIL-2\nDurvalumab","Interventional","Treatment","Sequential Assignment","None (Open Label)","Non-Randomized","18 Years",null,"All",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":19},"Objective Response Rate|â‰¥ Grade 3 adverse event (AE)","To evaluate efficacy using the objective response rate (ORR|To evaluate the safety as measured by any â‰¥ Grade 3 adverse event (AE) rate","A maximum of 24 months","Duration of Response|Progression Free Survival|Overall Survival","To further evaluate efficacy such as the duration of response (DOR)|To further evaluate efficacy such as progression free survival (PFS) (PFS)|To further evaluate efficacy such as overall survival (OS)","A maximum of 24 months|A minimum of 3 years","clinical.inquiries@iovance.com","Iovance Biotherapeutics Clinical Inquiries","855-860-5466","Morristown, New Jersey, United States, 07960","New Jersey","United States","Iovance Investigational Site","clinical.inquiries@iovance.com","Iovance Biotherapeutics Clinical Inquiries","650-260-7120","Iovance Medical Monitor","2018-03-01","2020-05-25T16:40:06.255","2020-05-26T17:10:42.972","NCT03419559"]
["5ecbf4e5feab101b15530a32","NCT03419559","2018-03-13","Iovance Biotherapeutics","IOVA","Recruiting","Study of Autologous Tumor Infiltrating Lymphocytes (LN-145) Alone and In Combo With Durvalumab in Non-Small Cell Lung Cancer","Ln-145|Durvalumab","PDL-1 Inhibitor","Yes","['Ln-145']","No",null,"Phase 2",2,24,"Anticipated","2018-02-28","2021-12-01","RR","Response Rate",{"$nulls":3},"This study is a Phase 2, open-label, 2-cohort, multicenter study evaluating adoptive cell therapy (ACT) with autologous TIL therapy (LN-145) alone, (Cohort 1), or in combination with durvalumab (anti-programmed cell death ligand 1 [PD-L1] monoclonal antibody [mAb]) (Cohort 2).","LN-145 is an adoptive cell transfer therapy that utilizes an autologous TIL manufacturing process, as originally developed by the NCI. The cell transfer therapy used in this study involves patients receiving a nonmyeloablative (NMA) lymphocyte depleting preparative regimen, followed by infusion of autologous TIL followed by the administration of up to 6 doses of IL-2. Patients in Cohort 2 will also receive durvalumab Q4Weeks until progression or unacceptable toxicity.","A Phase 2 Study to Assess the Efficacy and Safety of Autologous Tumor Infiltrating Lymphocytes (LN-145) Alone and In Combination With Anti-PD-L1 Inhibitor Durvalumab (MEDI4736) in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)","IOV-LUN-201","Non Small Cell Lung Cancer","Lung Cancer|Small Cell Lung Cancer|Non-Small-Cell Lung Cancer","Oncology Solid Tumor","Oncology","Experimental|Active Comparator","Cohort 1 LN-145 alone|Cohort 2 LN-145 in combination with durvalumab","After nonmyeloablative (NMA) lymphodepletion, patients are infused with their autologous (LN-145) followed by IL-2 administration|After nonmyeloablative (NMA) lymphodepletion, patients are infused with their autologous (LN-145) followed by IL-2 administration. Patients in cohort 2 will also receive durvalumab Q4Weeks","Biological|Drug","LN-145|Durvalumab","adoptive cell therapy (ACT) with autologous TIL therapy|PD-L1 antagonist monoclonal antibody","MEDI4736","Cohort 1 LN-145 alone|Cohort 2 LN-145 in combination with durvalumab","\n\n * Confirmed diagnosis of Stage III or Stage IV NSCLC and have received â‰¥ 1 line of prior systemic therapy in the locally advanced or metastatic setting\n * Have at least 1 resectable lesion to generate TIL\n * Measurable disease as defined by Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)\n * Male or female, â‰¥ 18 years of age\n * Body weight > 30 kg\n * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and estimated life expectancy of â‰¥ 3 months\n * Adequate bone marrow function at screening\n * Adequate organ function at screening\n * If the patient is of childbearing potential or their partner(s) is of childbearing potential, they must agree to use highly effective method of contraception while on study and for 6 months after receiving all protocol-related therapy.\n\n","\n\n * Must not have a history of other malignancies, except for adequately treated nonmelanoma skin cancer, curatively treated in-situ cancer of the cervix, curatively-treated thyroid cancer, or other solid tumors curatively treated with no evidence of disease for â‰¥ 3 years\n * Patients may not have received prior cell therapy\n * Patients may not have received prior anti PD-1 or anti PD-L1 inhibitors\n * Active or prior documented autoimmune or inflammatory disorders\n * History of primary immunodeficiency, history of allogeneic organ transplant that requires therapeutic immunosuppression\n * Received live or attenuated vaccination within 28 days prior to the start of NMA-LD\n * History of hypersensitivity to cyclophosphamide, fludarabine, dimethyl sulfoxide (DMSO) or IL-2\n * Known allergic reaction to antibiotics of the aminoglycoside group (ie, streptomycin, gentamicin)\n * Mean QT interval â‰¥ 470 msec\n * Decreased cardiac function as evidenced by a left ventricular ejection fraction of < 45%\n * Uncontrolled intercurrent illness\n * Patients who have obstructive or restrictive pulmonary disease and have a documented FEV1 (forced expiratory volume in 1 second) of â‰¤ 60%\n * Active central nervous system metastases and/or leptomeningeal disease\n * Current or prior use of immunosuppressive medication within 28 days before the first study treatment",{"$nulls":4},"Actual","2018-02-05","Actual","Anticipated","2022-12-01","Anticipated","2018-03-01","2018-01-14","2018-01-26","2018-03-10","Yes","LN-145\nCell Therapy\nAutologous Adoptive Cell Transfer\nCellular Immuno-therapy\nTIL\nIL-2\nDurvalumab","Interventional","Treatment","Sequential Assignment","None (Open Label)","Non-Randomized","18 Years",null,"All",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":19},"Objective Response Rate|â‰¥ Grade 3 adverse event (AE)","To evaluate efficacy using the objective response rate (ORR|To evaluate the safety as measured by any â‰¥ Grade 3 adverse event (AE) rate","A maximum of 24 months","Duration of Response|Progression Free Survival|Overall Survival","To further evaluate efficacy such as the duration of response (DOR)|To further evaluate efficacy such as progression free survival (PFS) (PFS)|To further evaluate efficacy such as overall survival (OS)","A maximum of 24 months|A minimum of 3 years","clinical.inquiries@iovance.com","Iovance Biotherapeutics Clinical Inquiries","855-860-5466","Morristown, New Jersey, United States, 07960","New Jersey","United States","Iovance Investigational Site","clinical.inquiries@iovance.com","Iovance Biotherapeutics Clinical Inquiries","650-260-7120","Iovance Medical Monitor","2018-03-10","2020-05-25T16:40:05.620","2020-05-26T17:10:42.972","NCT03419559"]
["5ecbf4e5fe30261b1a048403","NCT03419559","2018-03-26","Iovance Biotherapeutics","IOVA","Recruiting","Study of Autologous Tumor Infiltrating Lymphocytes (LN-145) Alone and In Combo With Durvalumab in Non-Small Cell Lung Cancer","Ln-145|Durvalumab","PDL-1 Inhibitor","Yes","['Ln-145']","No",null,"Phase 2",2,24,"Anticipated","2018-02-28","2021-12-01","RR","Response Rate",{"$nulls":3},"This study is a Phase 2, open-label, 2-cohort, multicenter study evaluating adoptive cell therapy (ACT) with autologous TIL therapy (LN-145) alone, (Cohort 1), or in combination with durvalumab (anti-programmed cell death ligand 1 [PD-L1] monoclonal antibody [mAb]) (Cohort 2).","LN-145 is an adoptive cell transfer therapy that utilizes an autologous TIL manufacturing process, as originally developed by the NCI. The cell transfer therapy used in this study involves patients receiving a nonmyeloablative (NMA) lymphocyte depleting preparative regimen, followed by infusion of autologous TIL followed by the administration of up to 6 doses of IL-2. Patients in Cohort 2 will also receive durvalumab Q4Weeks until progression or unacceptable toxicity.","A Phase 2 Study to Assess the Efficacy and Safety of Autologous Tumor Infiltrating Lymphocytes (LN-145) Alone and In Combination With Anti-PD-L1 Inhibitor Durvalumab (MEDI4736) in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)","IOV-LUN-201","Non Small Cell Lung Cancer","Lung Cancer|Small Cell Lung Cancer|Non-Small-Cell Lung Cancer","Oncology Solid Tumor","Oncology","Experimental|Active Comparator","Cohort 1 LN-145 alone|Cohort 2 LN-145 in combination with durvalumab","After nonmyeloablative (NMA) lymphodepletion, patients are infused with their autologous (LN-145) followed by IL-2 administration|After nonmyeloablative (NMA) lymphodepletion, patients are infused with their autologous (LN-145) followed by IL-2 administration. Patients in cohort 2 will also receive durvalumab Q4Weeks","Biological|Drug","LN-145|Durvalumab","adoptive cell therapy (ACT) with autologous TIL therapy|PD-L1 antagonist monoclonal antibody","MEDI4736","Cohort 1 LN-145 alone|Cohort 2 LN-145 in combination with durvalumab","\n\n * Confirmed diagnosis of Stage III or Stage IV NSCLC and have received â‰¥ 1 line of prior systemic therapy in the locally advanced or metastatic setting\n * Have at least 1 resectable lesion to generate TIL\n * Measurable disease as defined by Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)\n * Male or female, â‰¥ 18 years of age\n * Body weight > 30 kg\n * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and estimated life expectancy of â‰¥ 3 months\n * Adequate bone marrow function at screening\n * Adequate organ function at screening\n * If the patient is of childbearing potential or their partner(s) is of childbearing potential, they must agree to use highly effective method of contraception while on study and for 6 months after receiving all protocol-related therapy.\n\n","\n\n * Must not have a history of other malignancies, except for adequately treated nonmelanoma skin cancer, curatively treated in-situ cancer of the cervix, curatively-treated thyroid cancer, or other solid tumors curatively treated with no evidence of disease for â‰¥ 3 years\n * Patients may not have received prior cell therapy\n * Patients may not have received prior anti PD-1 or anti PD-L1 inhibitors\n * Active or prior documented autoimmune or inflammatory disorders\n * History of primary immunodeficiency, history of allogeneic organ transplant that requires therapeutic immunosuppression\n * Received live or attenuated vaccination within 28 days prior to the start of NMA-LD\n * History of hypersensitivity to cyclophosphamide, fludarabine, dimethyl sulfoxide (DMSO) or IL-2\n * Known allergic reaction to antibiotics of the aminoglycoside group (ie, streptomycin, gentamicin)\n * Mean QT interval â‰¥ 470 msec\n * Decreased cardiac function as evidenced by a left ventricular ejection fraction of < 45%\n * Uncontrolled intercurrent illness\n * Patients who have obstructive or restrictive pulmonary disease and have a documented FEV1 (forced expiratory volume in 1 second) of â‰¤ 60%\n * Active central nervous system metastases and/or leptomeningeal disease\n * Current or prior use of immunosuppressive medication within 28 days before the first study treatment",{"$nulls":4},"Actual","2018-02-05","Actual","Anticipated","2022-12-01","Anticipated","2018-03-01","2018-01-14","2018-01-26","2018-03-22","Yes","LN-145\nCell Therapy\nAutologous Adoptive Cell Transfer\nCellular Immuno-therapy\nTIL\nIL-2\nDurvalumab","Interventional","Treatment","Sequential Assignment","None (Open Label)","Non-Randomized","18 Years",null,"All",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":19},"Objective Response Rate|â‰¥ Grade 3 adverse event (AE)","To evaluate efficacy using the objective response rate (ORR|To evaluate the safety as measured by any â‰¥ Grade 3 adverse event (AE) rate","A maximum of 24 months","Duration of Response|Progression Free Survival|Overall Survival","To further evaluate efficacy such as the duration of response (DOR)|To further evaluate efficacy such as progression free survival (PFS) (PFS)|To further evaluate efficacy such as overall survival (OS)","A maximum of 24 months|A minimum of 3 years","clinical.inquiries@iovance.com","Iovance Biotherapeutics Clinical Inquiries","855-860-5466","Louisville, Kentucky, United States, 40202|Morristown, New Jersey, United States, 07960|Pittsburgh, Pennsylvania, United States, 15232","Kentucky|New Jersey|Pennsylvania","United States","Iovance Investigational Site","clinical.inquiries@iovance.com","Iovance Biotherapeutics Clinical Inquiries","650-260-7120","Iovance Medical Monitor","2018-03-22","2020-05-25T16:40:05.545","2020-05-26T17:10:42.972","NCT03419559"]
["5ecbf4e511702c1b1b916c0f","NCT03419559","2018-03-29","Iovance Biotherapeutics","IOVA","Recruiting","Study of Autologous Tumor Infiltrating Lymphocytes (LN-145) Alone and In Combo With Durvalumab in Non-Small Cell Lung Cancer","Ln-145|Durvalumab","PDL-1 Inhibitor","Yes","['Ln-145']","No",null,"Phase 2",2,24,"Anticipated","2018-02-28","2021-12-01","RR","Response Rate",{"$nulls":3},"This study is a Phase 2, open-label, 2-cohort, multicenter study evaluating adoptive cell therapy (ACT) with autologous TIL therapy (LN-145) alone, (Cohort 1), or in combination with durvalumab (anti-programmed cell death ligand 1 [PD-L1] monoclonal antibody [mAb]) (Cohort 2).","LN-145 is an adoptive cell transfer therapy that utilizes an autologous TIL manufacturing process, as originally developed by the NCI. The cell transfer therapy used in this study involves patients receiving a nonmyeloablative (NMA) lymphocyte depleting preparative regimen, followed by infusion of autologous TIL followed by the administration of up to 6 doses of IL-2. Patients in Cohort 2 will also receive durvalumab Q4Weeks until progression or unacceptable toxicity.","A Phase 2 Study to Assess the Efficacy and Safety of Autologous Tumor Infiltrating Lymphocytes (LN-145) Alone and In Combination With Anti-PD-L1 Inhibitor Durvalumab (MEDI4736) in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)","IOV-LUN-201","Non Small Cell Lung Cancer","Lung Cancer|Small Cell Lung Cancer|Non-Small-Cell Lung Cancer","Oncology Solid Tumor","Oncology","Experimental|Active Comparator","Cohort 1 LN-145 alone|Cohort 2 LN-145 in combination with durvalumab","After nonmyeloablative (NMA) lymphodepletion, patients are infused with their autologous (LN-145) followed by IL-2 administration|After nonmyeloablative (NMA) lymphodepletion, patients are infused with their autologous (LN-145) followed by IL-2 administration. Patients in cohort 2 will also receive durvalumab Q4Weeks","Biological|Drug","LN-145|Durvalumab","adoptive cell therapy (ACT) with autologous TIL therapy|PD-L1 antagonist monoclonal antibody","MEDI4736","Cohort 1 LN-145 alone|Cohort 2 LN-145 in combination with durvalumab","\n\n * Confirmed diagnosis of Stage III or Stage IV NSCLC and have received â‰¥ 1 line of prior systemic therapy in the locally advanced or metastatic setting\n * Have at least 1 resectable lesion to generate TIL\n * Measurable disease as defined by Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)\n * Male or female, â‰¥ 18 years of age\n * Body weight > 30 kg\n * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and estimated life expectancy of â‰¥ 3 months\n * Adequate bone marrow function at screening\n * Adequate organ function at screening\n * If the patient is of childbearing potential or their partner(s) is of childbearing potential, they must agree to use highly effective method of contraception while on study and for 6 months after receiving all protocol-related therapy.\n\n","\n\n * Must not have a history of other malignancies, except for adequately treated nonmelanoma skin cancer, curatively treated in-situ cancer of the cervix, curatively-treated thyroid cancer, or other solid tumors curatively treated with no evidence of disease for â‰¥ 3 years\n * Patients may not have received prior cell therapy\n * Patients may not have received prior anti PD-1 or anti PD-L1 inhibitors\n * Active or prior documented autoimmune or inflammatory disorders\n * History of primary immunodeficiency, history of allogeneic organ transplant that requires therapeutic immunosuppression\n * Received live or attenuated vaccination within 28 days prior to the start of NMA-LD\n * History of hypersensitivity to cyclophosphamide, fludarabine, dimethyl sulfoxide (DMSO) or IL-2\n * Known allergic reaction to antibiotics of the aminoglycoside group (ie, streptomycin, gentamicin)\n * Mean QT interval â‰¥ 470 msec\n * Decreased cardiac function as evidenced by a left ventricular ejection fraction of < 45%\n * Uncontrolled intercurrent illness\n * Patients who have obstructive or restrictive pulmonary disease and have a documented FEV1 (forced expiratory volume in 1 second) of â‰¤ 60%\n * Active central nervous system metastases and/or leptomeningeal disease\n * Current or prior use of immunosuppressive medication within 28 days before the first study treatment",{"$nulls":4},"Actual","2018-02-05","Actual","Anticipated","2022-12-01","Anticipated","2018-03-01","2018-01-14","2018-01-26","2018-03-28","Yes","LN-145\nCell Therapy\nAutologous Adoptive Cell Transfer\nCellular Immuno-therapy\nTIL\nIL-2\nDurvalumab","Interventional","Treatment","Sequential Assignment","None (Open Label)","Non-Randomized","18 Years",null,"All",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":19},"Objective Response Rate|â‰¥ Grade 3 adverse event (AE)","To evaluate efficacy using the objective response rate (ORR|To evaluate the safety as measured by any â‰¥ Grade 3 adverse event (AE) rate","A maximum of 24 months","Duration of Response|Progression Free Survival|Overall Survival","To further evaluate efficacy such as the duration of response (DOR)|To further evaluate efficacy such as progression free survival (PFS) (PFS)|To further evaluate efficacy such as overall survival (OS)","A maximum of 24 months|A minimum of 3 years","clinical.inquiries@iovance.com","Iovance Biotherapeutics Clinical Inquiries","855-860-5466","Louisville, Kentucky, United States, 40202|Morristown, New Jersey, United States, 07960|Portland, Oregon, United States, 97213|Pittsburgh, Pennsylvania, United States, 15232","Kentucky|New Jersey|Oregon|Pennsylvania","United States","Iovance Investigational Site","clinical.inquiries@iovance.com","Iovance Biotherapeutics Clinical Inquiries","650-260-7120","Iovance Medical Monitor","2018-03-28","2020-05-25T16:40:05.837","2020-05-26T17:10:42.972","NCT03419559"]
["5ecbf4e6307e3d1b1f8d9e95","NCT03419559","2018-05-17","Iovance Biotherapeutics","IOVA","Recruiting","Study of Autologous Tumor Infiltrating Lymphocytes (LN-145) Alone and In Combo With Durvalumab in Non-Small Cell Lung Cancer","Ln-145|Durvalumab","PDL-1 Inhibitor","Yes","['Ln-145']","No",null,"Phase 2",2,24,"Anticipated","2018-02-28","2021-12-01","RR","Response Rate",{"$nulls":3},"This study is a Phase 2, open-label, 2-cohort, multicenter study evaluating adoptive cell therapy (ACT) with autologous TIL therapy (LN-145) alone, (Cohort 1), or in combination with durvalumab (anti-programmed cell death ligand 1 [PD-L1] monoclonal antibody [mAb]) (Cohort 2).","LN-145 is an adoptive cell transfer therapy that utilizes an autologous TIL manufacturing process, as originally developed by the NCI. The cell transfer therapy used in this study involves patients receiving a nonmyeloablative (NMA) lymphocyte depleting preparative regimen, followed by infusion of autologous TIL followed by the administration of up to 6 doses of IL-2. Patients in Cohort 2 will also receive durvalumab Q4Weeks until progression or unacceptable toxicity.","A Phase 2 Study to Assess the Efficacy and Safety of Autologous Tumor Infiltrating Lymphocytes (LN-145) Alone and In Combination With Anti-PD-L1 Inhibitor Durvalumab (MEDI4736) in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)","IOV-LUN-201","Non Small Cell Lung Cancer","Lung Cancer|Small Cell Lung Cancer|Non-Small-Cell Lung Cancer","Oncology Solid Tumor","Oncology","Experimental|Active Comparator","Cohort 1 LN-145 alone|Cohort 2 LN-145 in combination with durvalumab","After nonmyeloablative (NMA) lymphodepletion, patients are infused with their autologous (LN-145) followed by IL-2 administration|After nonmyeloablative (NMA) lymphodepletion, patients are infused with their autologous (LN-145) followed by IL-2 administration. Patients in cohort 2 will also receive durvalumab Q4Weeks","Biological|Drug","LN-145|Durvalumab","adoptive cell therapy (ACT) with autologous TIL therapy|PD-L1 antagonist monoclonal antibody","MEDI4736","Cohort 1 LN-145 alone|Cohort 2 LN-145 in combination with durvalumab","\n\n * Confirmed diagnosis of Stage III or Stage IV NSCLC and have received â‰¥ 1 line of prior systemic therapy in the locally advanced or metastatic setting\n * Have at least 1 resectable lesion to generate TIL\n * Measurable disease as defined by Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)\n * Male or female, â‰¥ 18 years of age\n * Body weight > 30 kg\n * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and estimated life expectancy of â‰¥ 3 months\n * Adequate bone marrow function at screening\n * Adequate organ function at screening\n * If the patient is of childbearing potential or their partner(s) is of childbearing potential, they must agree to use highly effective method of contraception while on study and for 6 months after receiving all protocol-related therapy.\n\n","\n\n * Must not have a history of other malignancies, except for adequately treated nonmelanoma skin cancer, curatively treated in-situ cancer of the cervix, curatively-treated thyroid cancer, or other solid tumors curatively treated with no evidence of disease for â‰¥ 3 years\n * Patients may not have received prior cell therapy\n * Patients may not have received prior anti PD-1 or anti PD-L1 inhibitors\n * Active or prior documented autoimmune or inflammatory disorders\n * History of primary immunodeficiency, history of allogeneic organ transplant that requires therapeutic immunosuppression\n * Received live or attenuated vaccination within 28 days prior to the start of NMA-LD\n * History of hypersensitivity to cyclophosphamide, fludarabine, dimethyl sulfoxide (DMSO) or IL-2\n * Known allergic reaction to antibiotics of the aminoglycoside group (ie, streptomycin, gentamicin)\n * Mean QT interval â‰¥ 470 msec\n * Decreased cardiac function as evidenced by a left ventricular ejection fraction of < 45%\n * Uncontrolled intercurrent illness\n * Patients who have obstructive or restrictive pulmonary disease and have a documented FEV1 (forced expiratory volume in 1 second) of â‰¤ 60%\n * Active central nervous system metastases and/or leptomeningeal disease\n * Current or prior use of immunosuppressive medication within 28 days before the first study treatment",{"$nulls":4},"Actual","2018-02-05","Actual","Anticipated","2022-12-01","Anticipated","2018-05-01","2018-01-14","2018-01-26","2018-05-16","Yes","LN-145\nCell Therapy\nAutologous Adoptive Cell Transfer\nCellular Immuno-therapy\nTIL\nIL-2\nDurvalumab","Interventional","Treatment","Sequential Assignment","None (Open Label)","Non-Randomized","18 Years",null,"All",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":19},"Objective Response Rate|â‰¥ Grade 3 adverse event (AE)","To evaluate efficacy using the objective response rate (ORR|To evaluate the safety as measured by any â‰¥ Grade 3 adverse event (AE) rate","A maximum of 24 months","Duration of Response|Progression Free Survival|Overall Survival","To further evaluate efficacy such as the duration of response (DOR)|To further evaluate efficacy such as progression free survival (PFS) (PFS)|To further evaluate efficacy such as overall survival (OS)","A maximum of 24 months|A minimum of 3 years","clinical.inquiries@iovance.com","Iovance Biotherapeutics Clinical Inquiries","855-860-5466","Louisville, Kentucky, United States, 40202|Morristown, New Jersey, United States, 07960|Portland, Oregon, United States, 97213|Pittsburgh, Pennsylvania, United States, 15232|Nashville, Tennessee, United States, 37232","Kentucky|New Jersey|Oregon|Pennsylvania|Tennessee","United States","Iovance Investigational Site","clinical.inquiries@iovance.com","Iovance Biotherapeutics Clinical Inquiries","650-260-7120","Iovance Medical Monitor","2018-05-16","2020-05-25T16:40:06.202","2020-05-26T17:10:42.972","NCT03419559"]
["5ecbf4e5e2561b1b11905efe","NCT03419559","2018-06-21","Iovance Biotherapeutics","IOVA","Recruiting","Study of Autologous Tumor Infiltrating Lymphocytes (LN-145) Alone and In Combo With Durvalumab in Non-Small Cell Lung Cancer","Ln-145|Durvalumab","PDL-1 Inhibitor","Yes","['Ln-145']","No",null,"Phase 2",2,24,"Anticipated","2018-02-28","2021-12-01","RR","Response Rate",{"$nulls":3},"This study is a Phase 2, open-label, 2-cohort, multicenter study evaluating adoptive cell therapy (ACT) with autologous TIL therapy (LN-145) alone, (Cohort 1), or in combination with durvalumab (anti-programmed cell death ligand 1 [PD-L1] monoclonal antibody [mAb]) (Cohort 2).","LN-145 is an adoptive cell transfer therapy that utilizes an autologous TIL manufacturing process, as originally developed by the NCI. The cell transfer therapy used in this study involves patients receiving a nonmyeloablative (NMA) lymphocyte depleting preparative regimen, followed by infusion of autologous TIL followed by the administration of up to 6 doses of IL-2. Patients in Cohort 2 will also receive durvalumab Q4Weeks until progression or unacceptable toxicity.","A Phase 2 Study to Assess the Efficacy and Safety of Autologous Tumor Infiltrating Lymphocytes (LN-145) Alone and In Combination With Anti-PD-L1 Inhibitor Durvalumab (MEDI4736) in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)","IOV-LUN-201","Non Small Cell Lung Cancer","Lung Cancer|Small Cell Lung Cancer|Non-Small-Cell Lung Cancer","Oncology Solid Tumor","Oncology","Experimental|Active Comparator","Cohort 1 LN-145 alone|Cohort 2 LN-145 in combination with durvalumab","After nonmyeloablative (NMA) lymphodepletion, patients are infused with their autologous (LN-145) followed by IL-2 administration|After nonmyeloablative (NMA) lymphodepletion, patients are infused with their autologous (LN-145) followed by IL-2 administration. Patients in cohort 2 will also receive durvalumab Q4Weeks","Biological|Drug","LN-145|Durvalumab","adoptive cell therapy (ACT) with autologous TIL therapy|PD-L1 antagonist monoclonal antibody","MEDI4736","Cohort 1 LN-145 alone|Cohort 2 LN-145 in combination with durvalumab","\n\n * Confirmed diagnosis of Stage III or Stage IV NSCLC and have received â‰¥ 1 line of prior systemic therapy in the locally advanced or metastatic setting\n * Have at least 1 resectable lesion to generate TIL\n * Measurable disease as defined by Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)\n * Male or female, â‰¥ 18 years of age\n * Body weight > 30 kg\n * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and estimated life expectancy of â‰¥ 3 months\n * Adequate bone marrow function at screening\n * Adequate organ function at screening\n * If the patient is of childbearing potential or their partner(s) is of childbearing potential, they must agree to use highly effective method of contraception while on study and for 6 months after receiving all protocol-related therapy.\n\n","\n\n * Must not have a history of other malignancies, except for adequately treated nonmelanoma skin cancer, curatively treated in-situ cancer of the cervix, curatively-treated thyroid cancer, or other solid tumors curatively treated with no evidence of disease for â‰¥ 3 years\n * Patients may not have received prior cell therapy\n * Patients may not have received prior anti PD-1 or anti PD-L1 inhibitors\n * Active or prior documented autoimmune or inflammatory disorders\n * History of primary immunodeficiency, history of allogeneic organ transplant that requires therapeutic immunosuppression\n * Received live or attenuated vaccination within 28 days prior to the start of NMA-LD\n * History of hypersensitivity to cyclophosphamide, fludarabine, dimethyl sulfoxide (DMSO) or IL-2\n * Known allergic reaction to antibiotics of the aminoglycoside group (ie, streptomycin, gentamicin)\n * Mean QT interval â‰¥ 470 msec\n * Decreased cardiac function as evidenced by a left ventricular ejection fraction of < 45%\n * Uncontrolled intercurrent illness\n * Patients who have obstructive or restrictive pulmonary disease and have a documented FEV1 (forced expiratory volume in 1 second) of â‰¤ 60%\n * Active central nervous system metastases and/or leptomeningeal disease\n * Current or prior use of immunosuppressive medication within 28 days before the first study treatment",{"$nulls":4},"Actual","2018-02-05","Actual","Anticipated","2022-12-01","Anticipated","2018-06-01","2018-01-14","2018-01-26","2018-06-20","Yes","LN-145\nCell Therapy\nAutologous Adoptive Cell Transfer\nCellular Immuno-therapy\nTIL\nIL-2\nDurvalumab","Interventional","Treatment","Sequential Assignment","None (Open Label)","Non-Randomized","18 Years",null,"All",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":19},"Objective Response Rate|â‰¥ Grade 3 adverse event (AE)","To evaluate efficacy using the objective response rate (ORR|To evaluate the safety as measured by any â‰¥ Grade 3 adverse event (AE) rate","A maximum of 24 months","Duration of Response|Progression Free Survival|Overall Survival","To further evaluate efficacy such as the duration of response (DOR)|To further evaluate efficacy such as progression free survival (PFS) (PFS)|To further evaluate efficacy such as overall survival (OS)","A maximum of 24 months|A minimum of 3 years","clinical.inquiries@iovance.com","Iovance Biotherapeutics Clinical Inquiries","866-565-4410","Louisville, Kentucky, United States, 40202|Morristown, New Jersey, United States, 07960|Portland, Oregon, United States, 97213|Pittsburgh, Pennsylvania, United States, 15232|Nashville, Tennessee, United States, 37232","Kentucky|New Jersey|Oregon|Pennsylvania|Tennessee","United States","Iovance Investigational Site",{"$nulls":3},"Iovance Medical Monitor","2018-06-20","2020-05-25T16:40:05.900","2020-05-26T17:10:42.972","NCT03419559"]
["5ecbf4e611702c1b1b916c11","NCT03419559","2018-06-26","Iovance Biotherapeutics","IOVA","Recruiting","Study of Autologous Tumor Infiltrating Lymphocytes (LN-145) Alone and In Combo With Durvalumab in Non-Small Cell Lung Cancer","Ln-145|Durvalumab","PDL-1 Inhibitor","Yes","['Ln-145']","No",null,"Phase 2",2,24,"Anticipated","2018-02-28","2021-12-01","RR","Response Rate",{"$nulls":3},"This study is a Phase 2, open-label, 2-cohort, multicenter study evaluating adoptive cell therapy (ACT) with autologous TIL therapy (LN-145) alone, (Cohort 1), or in combination with durvalumab (anti-programmed cell death ligand 1 [PD-L1] monoclonal antibody [mAb]) (Cohort 2).","LN-145 is an adoptive cell transfer therapy that utilizes an autologous TIL manufacturing process, as originally developed by the NCI. The cell transfer therapy used in this study involves patients receiving a nonmyeloablative (NMA) lymphocyte depleting preparative regimen, followed by infusion of autologous TIL followed by the administration of up to 6 doses of IL-2. Patients in Cohort 2 will also receive durvalumab Q4Weeks until progression or unacceptable toxicity.","A Phase 2 Study to Assess the Efficacy and Safety of Autologous Tumor Infiltrating Lymphocytes (LN-145) Alone and In Combination With Anti-PD-L1 Inhibitor Durvalumab (MEDI4736) in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)","IOV-LUN-201","Non Small Cell Lung Cancer","Lung Cancer|Small Cell Lung Cancer|Non-Small-Cell Lung Cancer","Oncology Solid Tumor","Oncology","Experimental|Active Comparator","Cohort 1 LN-145 alone|Cohort 2 LN-145 in combination with durvalumab","After nonmyeloablative (NMA) lymphodepletion, patients are infused with their autologous (LN-145) followed by IL-2 administration|After nonmyeloablative (NMA) lymphodepletion, patients are infused with their autologous (LN-145) followed by IL-2 administration. Patients in cohort 2 will also receive durvalumab Q4Weeks","Biological|Drug","LN-145|Durvalumab","adoptive cell therapy (ACT) with autologous TIL therapy|PD-L1 antagonist monoclonal antibody","MEDI4736","Cohort 1 LN-145 alone|Cohort 2 LN-145 in combination with durvalumab","\n\n * Confirmed diagnosis of Stage III or Stage IV NSCLC and have received â‰¥ 1 line of prior systemic therapy in the locally advanced or metastatic setting\n * Have at least 1 resectable lesion to generate TIL\n * Measurable disease as defined by Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)\n * Male or female, â‰¥ 18 years of age\n * Body weight > 30 kg\n * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and estimated life expectancy of â‰¥ 3 months\n * Adequate bone marrow function at screening\n * Adequate organ function at screening\n * If the patient is of childbearing potential or their partner(s) is of childbearing potential, they must agree to use highly effective method of contraception while on study and for 6 months after receiving all protocol-related therapy.\n\n","\n\n * Must not have a history of other malignancies, except for adequately treated nonmelanoma skin cancer, curatively treated in-situ cancer of the cervix, curatively-treated thyroid cancer, or other solid tumors curatively treated with no evidence of disease for â‰¥ 3 years\n * Patients may not have received prior cell therapy\n * Patients may not have received prior anti PD-1 or anti PD-L1 inhibitors\n * Active or prior documented autoimmune or inflammatory disorders\n * History of primary immunodeficiency, history of allogeneic organ transplant that requires therapeutic immunosuppression\n * Received live or attenuated vaccination within 28 days prior to the start of NMA-LD\n * History of hypersensitivity to cyclophosphamide, fludarabine, dimethyl sulfoxide (DMSO) or IL-2\n * Known allergic reaction to antibiotics of the aminoglycoside group (ie, streptomycin, gentamicin)\n * Mean QT interval â‰¥ 470 msec\n * Decreased cardiac function as evidenced by a left ventricular ejection fraction of < 45%\n * Uncontrolled intercurrent illness\n * Patients who have obstructive or restrictive pulmonary disease and have a documented FEV1 (forced expiratory volume in 1 second) of â‰¤ 60%\n * Active central nervous system metastases and/or leptomeningeal disease\n * Current or prior use of immunosuppressive medication within 28 days before the first study treatment",{"$nulls":4},"Actual","2018-02-05","Actual","Anticipated","2022-12-01","Anticipated","2018-06-01","2018-01-14","2018-01-26","2018-06-22","Yes","LN-145\nCell Therapy\nAutologous Adoptive Cell Transfer\nCellular Immuno-therapy\nTIL\nIL-2\nDurvalumab","Interventional","Treatment","Sequential Assignment","None (Open Label)","Non-Randomized","18 Years",null,"All",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":19},"Objective Response Rate|â‰¥ Grade 3 adverse event (AE)","To evaluate efficacy using the objective response rate (ORR|To evaluate the safety as measured by any â‰¥ Grade 3 adverse event (AE) rate","A maximum of 24 months","Duration of Response|Progression Free Survival|Overall Survival","To further evaluate efficacy such as the duration of response (DOR)|To further evaluate efficacy such as progression free survival (PFS) (PFS)|To further evaluate efficacy such as overall survival (OS)","A maximum of 24 months|A minimum of 3 years","clinical.inquiries@iovance.com","Iovance Biotherapeutics Clinical Inquiries","866-565-4410","Louisville, Kentucky, United States, 40202|Morristown, New Jersey, United States, 07960|Portland, Oregon, United States, 97213|Pittsburgh, Pennsylvania, United States, 15232|Nashville, Tennessee, United States, 37232|Seattle, Washington, United States, 98195-0001","Kentucky|New Jersey|Oregon|Pennsylvania|Tennessee|Washington","United States","Iovance Investigational Site",{"$nulls":3},"Iovance Medical Monitor","2018-06-22","2020-05-25T16:40:06.421","2020-05-26T17:10:42.972","NCT03419559"]
["5ecbf4e6fe30261b1a048404","NCT03419559","2018-07-24","Iovance Biotherapeutics","IOVA","Recruiting","Study of Autologous Tumor Infiltrating Lymphocytes (LN-145) Alone and In Combo With Durvalumab in Non-Small Cell Lung Cancer","Ln-145|Durvalumab","PDL-1 Inhibitor","Yes","['Ln-145']","No",null,"Phase 2",2,24,"Anticipated","2018-02-28","2021-12-01","RR","Response Rate",{"$nulls":3},"This study is a Phase 2, open-label, 2-cohort, multicenter study evaluating adoptive cell therapy (ACT) with autologous TIL therapy (LN-145) alone, (Cohort 1), or in combination with durvalumab (anti-programmed cell death ligand 1 [PD-L1] monoclonal antibody [mAb]) (Cohort 2).","LN-145 is an adoptive cell transfer therapy that utilizes an autologous TIL manufacturing process, as originally developed by the NCI. The cell transfer therapy used in this study involves patients receiving a nonmyeloablative (NMA) lymphocyte depleting preparative regimen, followed by infusion of autologous TIL followed by the administration of up to 6 doses of IL-2. Patients in Cohort 2 will also receive durvalumab Q4Weeks until progression or unacceptable toxicity.","A Phase 2 Study to Assess the Efficacy and Safety of Autologous Tumor Infiltrating Lymphocytes (LN-145) Alone and In Combination With Anti-PD-L1 Inhibitor Durvalumab (MEDI4736) in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)","IOV-LUN-201","Non Small Cell Lung Cancer","Lung Cancer|Small Cell Lung Cancer|Non-Small-Cell Lung Cancer","Oncology Solid Tumor","Oncology","Experimental|Active Comparator","Cohort 1 LN-145 alone|Cohort 2 LN-145 in combination with durvalumab","After nonmyeloablative (NMA) lymphodepletion, patients are infused with their autologous (LN-145) followed by IL-2 administration|After nonmyeloablative (NMA) lymphodepletion, patients are infused with their autologous (LN-145) followed by IL-2 administration. Patients in cohort 2 will also receive durvalumab Q4Weeks","Biological|Drug","LN-145|Durvalumab","adoptive cell therapy (ACT) with autologous TIL therapy|PD-L1 antagonist monoclonal antibody","MEDI4736","Cohort 1 LN-145 alone|Cohort 2 LN-145 in combination with durvalumab","\n\n * Confirmed diagnosis of Stage III or Stage IV NSCLC and have received â‰¥ 1 line of prior systemic therapy in the locally advanced or metastatic setting\n * Have at least 1 resectable lesion to generate TIL\n * Measurable disease as defined by Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)\n * Male or female, â‰¥ 18 years of age\n * Body weight > 30 kg\n * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and estimated life expectancy of â‰¥ 3 months\n * Adequate bone marrow function at screening\n * Adequate organ function at screening\n * If the patient is of childbearing potential or their partner(s) is of childbearing potential, they must agree to use highly effective method of contraception while on study and for 6 months after receiving all protocol-related therapy.\n\n","\n\n * Must not have a history of other malignancies, except for adequately treated nonmelanoma skin cancer, curatively treated in-situ cancer of the cervix, curatively-treated thyroid cancer, or other solid tumors curatively treated with no evidence of disease for â‰¥ 3 years\n * Patients may not have received prior cell therapy\n * Patients may not have received prior anti PD-1 or anti PD-L1 inhibitors\n * Active or prior documented autoimmune or inflammatory disorders\n * History of primary immunodeficiency, history of allogeneic organ transplant that requires therapeutic immunosuppression\n * Received live or attenuated vaccination within 28 days prior to the start of NMA-LD\n * History of hypersensitivity to cyclophosphamide, fludarabine, dimethyl sulfoxide (DMSO) or IL-2\n * Known allergic reaction to antibiotics of the aminoglycoside group (ie, streptomycin, gentamicin)\n * Mean QT interval â‰¥ 470 msec\n * Decreased cardiac function as evidenced by a left ventricular ejection fraction of < 45%\n * Uncontrolled intercurrent illness\n * Patients who have obstructive or restrictive pulmonary disease and have a documented FEV1 (forced expiratory volume in 1 second) of â‰¤ 60%\n * Active central nervous system metastases and/or leptomeningeal disease\n * Current or prior use of immunosuppressive medication within 28 days before the first study treatment",{"$nulls":4},"Actual","2018-02-05","Actual","Anticipated","2022-12-01","Anticipated","2018-07-01","2018-01-14","2018-01-26","2018-07-23","Yes","LN-145\nCell Therapy\nAutologous Adoptive Cell Transfer\nCellular Immuno-therapy\nTIL\nIL-2\nDurvalumab","Interventional","Treatment","Sequential Assignment","None (Open Label)","Non-Randomized","18 Years",null,"All",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":19},"Objective Response Rate|â‰¥ Grade 3 adverse event (AE)","To evaluate efficacy using the objective response rate (ORR|To evaluate the safety as measured by any â‰¥ Grade 3 adverse event (AE) rate","A maximum of 24 months","Duration of Response|Progression Free Survival|Overall Survival","To further evaluate efficacy such as the duration of response (DOR)|To further evaluate efficacy such as progression free survival (PFS) (PFS)|To further evaluate efficacy such as overall survival (OS)","A maximum of 24 months|A minimum of 3 years","clinical.inquiries@iovance.com","Iovance Biotherapeutics Clinical Inquiries","866-565-4410","Louisville, Kentucky, United States, 40202|Detroit, Michigan, United States, 48201|Morristown, New Jersey, United States, 07960|Portland, Oregon, United States, 97213|Pittsburgh, Pennsylvania, United States, 15232|Nashville, Tennessee, United States, 37232|Seattle, Washington, United States, 98195-0001","Kentucky|Michigan|New Jersey|Oregon|Pennsylvania|Tennessee|Washington","United States","Iovance Investigational Site",{"$nulls":3},"Iovance Medical Monitor","2018-07-23","2020-05-25T16:40:06.200","2020-05-26T17:10:42.972","NCT03419559"]
["5ecbf4e6feab101b15530a33","NCT03419559","2018-08-17","Iovance Biotherapeutics","IOVA","Recruiting","Study of Autologous Tumor Infiltrating Lymphocytes (LN-145) Alone and In Combo With Durvalumab in Non-Small Cell Lung Cancer","Ln-145|Durvalumab","PDL-1 Inhibitor","Yes","['Ln-145']","No",null,"Phase 2",2,24,"Anticipated","2018-02-28","2021-12-01","RR","Response Rate",{"$nulls":3},"This study is a Phase 2, open-label, 2-cohort, multicenter study evaluating adoptive cell therapy (ACT) with autologous TIL therapy (LN-145) alone, (Cohort 1), or in combination with durvalumab (anti-programmed cell death ligand 1 [PD-L1] monoclonal antibody [mAb]) (Cohort 2).","LN-145 is an adoptive cell transfer therapy that utilizes an autologous TIL manufacturing process, as originally developed by the NCI. The cell transfer therapy used in this study involves patients receiving a nonmyeloablative (NMA) lymphocyte depleting preparative regimen, followed by infusion of autologous TIL followed by the administration of up to 6 doses of IL-2. Patients in Cohort 2 will also receive durvalumab Q4Weeks until progression or unacceptable toxicity.","A Phase 2 Study to Assess the Efficacy and Safety of Autologous Tumor Infiltrating Lymphocytes (LN-145) Alone and In Combination With Anti-PD-L1 Inhibitor Durvalumab (MEDI4736) in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)","IOV-LUN-201","Non Small Cell Lung Cancer","Lung Cancer|Small Cell Lung Cancer|Non-Small-Cell Lung Cancer","Oncology Solid Tumor","Oncology","Experimental|Active Comparator","Cohort 1 LN-145 alone|Cohort 2 LN-145 in combination with durvalumab","After nonmyeloablative (NMA) lymphodepletion, patients are infused with their autologous (LN-145) followed by IL-2 administration|After nonmyeloablative (NMA) lymphodepletion, patients are infused with their autologous (LN-145) followed by IL-2 administration. Patients in cohort 2 will also receive durvalumab Q4Weeks","Biological|Drug","LN-145|Durvalumab","adoptive cell therapy (ACT) with autologous TIL therapy|PD-L1 antagonist monoclonal antibody","MEDI4736","Cohort 1 LN-145 alone|Cohort 2 LN-145 in combination with durvalumab","\n\n * Confirmed diagnosis of Stage III or Stage IV NSCLC and have received â‰¥ 1 line of prior systemic therapy in the locally advanced or metastatic setting\n * Have at least 1 resectable lesion to generate TIL\n * Measurable disease as defined by Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)\n * Male or female, â‰¥ 18 years of age\n * Body weight > 30 kg\n * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and estimated life expectancy of â‰¥ 3 months\n * Adequate bone marrow function at screening\n * Adequate organ function at screening\n * If the patient is of childbearing potential or their partner(s) is of childbearing potential, they must agree to use highly effective method of contraception while on study and for 6 months after receiving all protocol-related therapy.\n\n","\n\n * Must not have a history of other malignancies, except for adequately treated nonmelanoma skin cancer, curatively treated in-situ cancer of the cervix, curatively-treated thyroid cancer, or other solid tumors curatively treated with no evidence of disease for â‰¥ 3 years\n * Patients may not have received prior cell therapy\n * Patients may not have received prior anti PD-1 or anti PD-L1 inhibitors\n * Active or prior documented autoimmune or inflammatory disorders\n * History of primary immunodeficiency, history of allogeneic organ transplant that requires therapeutic immunosuppression\n * Received live or attenuated vaccination within 28 days prior to the start of NMA-LD\n * History of hypersensitivity to cyclophosphamide, fludarabine, dimethyl sulfoxide (DMSO) or IL-2\n * Known allergic reaction to antibiotics of the aminoglycoside group (ie, streptomycin, gentamicin)\n * Mean QT interval â‰¥ 470 msec\n * Decreased cardiac function as evidenced by a left ventricular ejection fraction of < 45%\n * Uncontrolled intercurrent illness\n * Patients who have obstructive or restrictive pulmonary disease and have a documented FEV1 (forced expiratory volume in 1 second) of â‰¤ 60%\n * Active central nervous system metastases and/or leptomeningeal disease\n * Current or prior use of immunosuppressive medication within 28 days before the first study treatment",{"$nulls":4},"Actual","2018-02-05","Actual","Anticipated","2022-12-01","Anticipated","2018-08-01","2018-01-14","2018-01-26","2018-08-16","Yes","LN-145\nCell Therapy\nAutologous Adoptive Cell Transfer\nCellular Immuno-therapy\nTIL\nIL-2\nDurvalumab","Interventional","Treatment","Sequential Assignment","None (Open Label)","Non-Randomized","18 Years",null,"All",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":19},"Objective Response Rate|â‰¥ Grade 3 adverse event (AE)","To evaluate efficacy using the objective response rate (ORR|To evaluate the safety as measured by any â‰¥ Grade 3 adverse event (AE) rate","A maximum of 24 months","Duration of Response|Progression Free Survival|Overall Survival","To further evaluate efficacy such as the duration of response (DOR)|To further evaluate efficacy such as progression free survival (PFS) (PFS)|To further evaluate efficacy such as overall survival (OS)","A maximum of 24 months|A minimum of 3 years","clinical.inquiries@iovance.com","Iovance Biotherapeutics Clinical Inquiries","866-565-4410","Los Angeles, California, United States, 90095|Louisville, Kentucky, United States, 40202|Detroit, Michigan, United States, 48201|Morristown, New Jersey, United States, 07960|Portland, Oregon, United States, 97213|Pittsburgh, Pennsylvania, United States, 15232|Nashville, Tennessee, United States, 37232|Seattle, Washington, United States, 98195-0001","California|Kentucky|Michigan|New Jersey|Oregon|Pennsylvania|Tennessee|Washington","United States","Iovance Investigational Site",{"$nulls":3},"Iovance Medical Monitor","2018-08-16","2020-05-25T16:40:06.272","2020-05-26T17:10:42.972","NCT03419559"]
["5ecbf4e6feab101b15530a34","NCT03419559","2018-10-04","Iovance Biotherapeutics","IOVA","Recruiting","Study of Autologous Tumor Infiltrating Lymphocytes (LN-145) In Combo With Durvalumab in Non-Small Cell Lung Cancer","Ln-145|Durvalumab","PDL-1 Inhibitor","Yes","['Ln-145']","No",null,"Phase 2",1,12,"Anticipated","2018-02-28","2021-12-01","RR","Response Rate",{"$nulls":3},"This study is a Phase 2, open-label, multicenter study evaluating adoptive cell therapy (ACT) with autologous TIL therapy (LN-145) in combination with Anti-PD-L1 inhibitor durvalumab.","LN-145 is an adoptive cell transfer therapy that utilizes an autologous TIL manufacturing process, as originally developed by the NCI. The cell transfer therapy used in this study involves patients receiving a nonmyeloablative (NMA) lymphocyte depleting preparative regimen, followed by infusion of autologous TIL followed by the administration of a regimen of IL-2.","A Phase 2 Study to Assess the Efficacy and Safety of Autologous Tumor Infiltrating Lymphocytes (LN-145) In Combination With Anti-PD-L1 Inhibitor Durvalumab (MEDI4736) in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)","IOV-LUN-201","Non Small Cell Lung Cancer","Lung Cancer|Small Cell Lung Cancer|Non-Small-Cell Lung Cancer","Oncology Solid Tumor","Oncology","Experimental","LN-145 in combination with durvalumab","After nonmyeloablative (NMA) lymphodepletion, patients are infused with their autologous TIL (LN-145) followed by IL-2 administration.","Biological|Drug","LN-145|Durvalumab","adoptive cell therapy (ACT) with autologous TIL therapy|PD-L1 antagonist monoclonal antibody","TIL, autologous tumor infiltrating lymphocytes|MEDI4736","LN-145 in combination with durvalumab","\n\n * Confirmed diagnosis of Stage III or Stage IV NSCLC and progressed after â‰¤ 3 lines of prior systemic therapy in the locally advanced or metastatic setting\n * Have at least 1 lesion resectable for TIL generation\n * Measurable disease as defined by RECIST v1.1\n * Male or female, â‰¥ 18 years of age\n * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and estimated life expectancy of â‰¥ 3 months\n * Adequate bone marrow function at screening\n * Adequate organ function at screening\n * A washout period from prior anticancer therapy(ies) of a minimum duration is required prior to first study treatment\n * Recovered from all prior anticancer therapy-related AEs to Grade 1 or less (per CTCAE v4.03) prior to enrollment\n * Female patients of childbearing potential and male patients with partners of childbearing potential patient must agree to use contraception while on study and during the timeframes as specified following the last dose of study drug(s) received, or until the first dose of the subsequent anticancer therapy, whichever is longer\n * Evidence of postmenopausal status or negative urine or serum pregnancy test for female premenopausal patients\n\n","\n\n * History of other malignancies, except for the following: adequately treated nonmelanoma skin cancer, curatively treated in-situ cancer of the cervix, curatively-treated thyroid cancer, or other solid tumors curatively treated with no evidence of disease for â‰¥ 3 years\n * Patients who have received prior cell therapy\n * Patients who have received prior checkpoint inhibitors: such as anti-PD-1, anti-PD-L1 inhibitors, and durvalumab\n * Active or prior documented autoimmune or inflammatory disorders\n * History of primary or acquired immunodeficiency syndrome, history of allogeneic organ transplant that requires therapeutic immunosuppression\n * Received live or attenuated vaccination within 28 days prior to the start of NMA-LD\n * Patients with a history of hypersensitivity to any component of the study drugs\n * Mean QT interval â‰¥ 470 msec\n * Patients who have a left ventricular ejection fraction (LVEF) of < 45% or who are New York Heart Association (NYHA) Class 2 or higher\n * Serious illnesses or medical conditions, which would pose increased risk for study participation and/or compliance with the protocol\n * Patients who have obstructive or restrictive pulmonary disease and have a documented FEV1 (forced expiratory volume in 1 second) of â‰¤ 60%\n * Active central nervous system metastases and/or leptomeningeal disease\n * Female patients who are pregnant or breastfeeding\n * Active infection including tuberculosis (TB), hepatitis B, hepatitis C, or HIV\n * Current or prior use of immunosuppressive medication within 28 days before the first dose of study treatment, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid",{"$nulls":4},"Actual","2018-02-05","Actual","Anticipated","2024-12-01","Anticipated","2018-10-01","2018-01-14","2018-01-26","2018-10-02","Yes","LN-145\nCell Therapy\nAutologous Adoptive Cell Transfer\nCellular Immuno-therapy\nTIL\nIL-2\nDurvalumab","Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":19},"Objective Response Rate|â‰¥ Grade 3 Treatment-Emergent Adverse Event","To evaluate efficacy using the objective response rate (ORR)|To evaluate the safety as measured by any â‰¥ Grade 3 treatment-emergent adverse event (TEAE) rate","A maximum of 24 months","Duration of Response|Progression Free Survival|Overall Survival","To further evaluate efficacy such as the duration of response (DOR)|To further evaluate efficacy such as progression free survival (PFS)|To further evaluate efficacy such as overall survival (OS)","A maximum of 24 months|A minimum of 5 years","clinical.inquiries@iovance.com","Iovance Biotherapeutics Clinical Inquiries","866-565-4410","Los Angeles, California, United States, 90095|Louisville, Kentucky, United States, 40202|Detroit, Michigan, United States, 48201|Morristown, New Jersey, United States, 07960|Portland, Oregon, United States, 97213|Pittsburgh, Pennsylvania, United States, 15232|Nashville, Tennessee, United States, 37232|Seattle, Washington, United States, 98195-0001","California|Kentucky|Michigan|New Jersey|Oregon|Pennsylvania|Tennessee|Washington","United States","Iovance Investigational Site",{"$nulls":3},"Iovance Medical Monitor","2018-10-02","2020-05-25T16:40:06.437","2020-05-26T17:10:42.972","NCT03419559"]
["5ecbf4e6e2561b1b11905eff","NCT03419559","2018-10-10","Iovance Biotherapeutics","IOVA","Recruiting","Study of Autologous Tumor Infiltrating Lymphocytes (LN-145) In Combo With Durvalumab in Non-Small Cell Lung Cancer","Ln-145|Durvalumab","PDL-1 Inhibitor","Yes","['Ln-145']","No",null,"Phase 2",1,12,"Anticipated","2018-02-28","2021-12-01","RR","Response Rate",{"$nulls":3},"This study is a Phase 2, open-label, multicenter study evaluating adoptive cell therapy (ACT) with autologous TIL therapy (LN-145) in combination with Anti-PD-L1 inhibitor durvalumab.","LN-145 is an adoptive cell transfer therapy that utilizes an autologous TIL manufacturing process, as originally developed by the NCI. The cell transfer therapy used in this study involves patients receiving a nonmyeloablative (NMA) lymphocyte depleting preparative regimen, followed by infusion of autologous TIL followed by the administration of a regimen of IL-2.","A Phase 2 Study to Assess the Efficacy and Safety of Autologous Tumor Infiltrating Lymphocytes (LN-145) In Combination With Anti-PD-L1 Inhibitor Durvalumab (MEDI4736) in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)","IOV-LUN-201","Non Small Cell Lung Cancer","Lung Cancer|Small Cell Lung Cancer|Non-Small-Cell Lung Cancer","Oncology Solid Tumor","Oncology","Experimental","LN-145 in combination with durvalumab","After nonmyeloablative (NMA) lymphodepletion, patients are infused with their autologous TIL (LN-145) followed by IL-2 administration.","Biological|Drug","LN-145|Durvalumab","adoptive cell therapy (ACT) with autologous TIL therapy|PD-L1 antagonist monoclonal antibody","TIL, autologous tumor infiltrating lymphocytes|MEDI4736","LN-145 in combination with durvalumab","\n\n * Confirmed diagnosis of Stage III or Stage IV NSCLC and progressed after â‰¤ 3 lines of prior systemic therapy in the locally advanced or metastatic setting\n * Have at least 1 lesion resectable for TIL generation\n * Measurable disease as defined by RECIST v1.1\n * Male or female, â‰¥ 18 years of age\n * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and estimated life expectancy of â‰¥ 3 months\n * Adequate bone marrow function at screening\n * Adequate organ function at screening\n * A washout period from prior anticancer therapy(ies) of a minimum duration is required prior to first study treatment\n * Recovered from all prior anticancer therapy-related AEs to Grade 1 or less (per CTCAE v4.03) prior to enrollment\n * Female patients of childbearing potential and male patients with partners of childbearing potential patient must agree to use contraception while on study and during the timeframes as specified following the last dose of study drug(s) received, or until the first dose of the subsequent anticancer therapy, whichever is longer\n * Evidence of postmenopausal status or negative urine or serum pregnancy test for female premenopausal patients\n\n","\n\n * History of other malignancies, except for the following: adequately treated nonmelanoma skin cancer, curatively treated in-situ cancer of the cervix, curatively-treated thyroid cancer, or other solid tumors curatively treated with no evidence of disease for â‰¥ 3 years\n * Patients who have received prior cell therapy\n * Patients who have received prior checkpoint inhibitors: such as anti-PD-1, anti-PD-L1 inhibitors, and durvalumab\n * Active or prior documented autoimmune or inflammatory disorders\n * History of primary or acquired immunodeficiency syndrome, history of allogeneic organ transplant that requires therapeutic immunosuppression\n * Received live or attenuated vaccination within 28 days prior to the start of NMA-LD\n * Patients with a history of hypersensitivity to any component of the study drugs\n * Mean QT interval â‰¥ 470 msec\n * Patients who have a left ventricular ejection fraction (LVEF) of < 45% or who are New York Heart Association (NYHA) Class 2 or higher\n * Serious illnesses or medical conditions, which would pose increased risk for study participation and/or compliance with the protocol\n * Patients who have obstructive or restrictive pulmonary disease and have a documented FEV1 (forced expiratory volume in 1 second) of â‰¤ 60%\n * Active central nervous system metastases and/or leptomeningeal disease\n * Female patients who are pregnant or breastfeeding\n * Active infection including tuberculosis (TB), hepatitis B, hepatitis C, or HIV\n * Current or prior use of immunosuppressive medication within 28 days before the first dose of study treatment, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid",{"$nulls":4},"Actual","2018-02-05","Actual","Anticipated","2024-12-01","Anticipated","2018-10-01","2018-01-14","2018-01-26","2018-10-09","Yes","LN-145\nCell Therapy\nAutologous Adoptive Cell Transfer\nCellular Immuno-therapy\nTIL\nIL-2\nDurvalumab","Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":19},"Objective Response Rate|â‰¥ Grade 3 Treatment-Emergent Adverse Event","To evaluate efficacy using the objective response rate (ORR)|To evaluate the safety as measured by any â‰¥ Grade 3 treatment-emergent adverse event (TEAE) rate","A maximum of 24 months","Duration of Response|Progression Free Survival|Overall Survival","To further evaluate efficacy such as the duration of response (DOR)|To further evaluate efficacy such as progression free survival (PFS)|To further evaluate efficacy such as overall survival (OS)","A maximum of 24 months|A minimum of 5 years","clinical.inquiries@iovance.com","Iovance Biotherapeutics Clinical Inquiries","866-565-4410","Los Angeles, California, United States, 90095 Iovance Investigational SiteSan Diego, California, United States, 92093|Louisville, Kentucky, United States, 40202|Detroit, Michigan, United States, 48201|Morristown, New Jersey, United States, 07960|Portland, Oregon, United States, 97213|Pittsburgh, Pennsylvania, United States, 15232|Nashville, Tennessee, United States, 37232|Seattle, Washington, United States, 98195-0001","California|Kentucky|Michigan|New Jersey|Oregon|Pennsylvania|Tennessee|Washington","United States","Iovance Investigational Site",{"$nulls":3},"Iovance Medical Monitor","2018-10-09","2020-05-25T16:40:06.308","2020-05-26T17:10:42.972","NCT03419559"]
["5ecbf4e6fe30261b1a048405","NCT03419559","2018-11-09","Iovance Biotherapeutics","IOVA","Recruiting","Study of Autologous Tumor Infiltrating Lymphocytes (LN-145) In Combo With Durvalumab in Non-Small Cell Lung Cancer","Ln-145|Durvalumab","PDL-1 Inhibitor","Yes","['Ln-145']","No",null,"Phase 2",1,12,"Anticipated","2018-02-28","2021-12-01","RR","Response Rate",{"$nulls":3},"This study is a Phase 2, open-label, multicenter study evaluating adoptive cell therapy (ACT) with autologous TIL therapy (LN-145) in combination with Anti-PD-L1 inhibitor durvalumab.","LN-145 is an adoptive cell transfer therapy that utilizes an autologous TIL manufacturing process, as originally developed by the NCI. The cell transfer therapy used in this study involves patients receiving a nonmyeloablative (NMA) lymphocyte depleting preparative regimen, followed by infusion of autologous TIL followed by the administration of a regimen of IL-2.","A Phase 2 Study to Assess the Efficacy and Safety of Autologous Tumor Infiltrating Lymphocytes (LN-145) In Combination With Anti-PD-L1 Inhibitor Durvalumab (MEDI4736) in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)","IOV-LUN-201","Non Small Cell Lung Cancer","Lung Cancer|Small Cell Lung Cancer|Non-Small-Cell Lung Cancer","Oncology Solid Tumor","Oncology","Experimental","LN-145 in combination with durvalumab","After nonmyeloablative (NMA) lymphodepletion, patients are infused with their autologous TIL (LN-145) followed by IL-2 administration.","Biological|Drug","LN-145|Durvalumab","adoptive cell therapy (ACT) with autologous TIL therapy|PD-L1 antagonist monoclonal antibody","TIL, autologous tumor infiltrating lymphocytes|MEDI4736","LN-145 in combination with durvalumab","\n\n * Confirmed diagnosis of Stage III or Stage IV NSCLC and progressed after â‰¤ 3 lines of prior systemic therapy in the locally advanced or metastatic setting\n * Have at least 1 lesion resectable for TIL generation\n * Measurable disease as defined by RECIST v1.1\n * Male or female, â‰¥ 18 years of age\n * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and estimated life expectancy of â‰¥ 3 months\n * Adequate bone marrow function at screening\n * Adequate organ function at screening\n * A washout period from prior anticancer therapy(ies) of a minimum duration is required prior to first study treatment\n * Recovered from all prior anticancer therapy-related AEs to Grade 1 or less (per CTCAE v4.03) prior to enrollment\n * Female patients of childbearing potential and male patients with partners of childbearing potential patient must agree to use contraception while on study and during the timeframes as specified following the last dose of study drug(s) received, or until the first dose of the subsequent anticancer therapy, whichever is longer\n * Evidence of postmenopausal status or negative urine or serum pregnancy test for female premenopausal patients\n\n","\n\n * History of other malignancies, except for the following: adequately treated nonmelanoma skin cancer, curatively treated in-situ cancer of the cervix, curatively-treated thyroid cancer, or other solid tumors curatively treated with no evidence of disease for â‰¥ 3 years\n * Patients who have received prior cell therapy\n * Patients who have received prior checkpoint inhibitors: such as anti-PD-1, anti-PD-L1 inhibitors, and durvalumab\n * Active or prior documented autoimmune or inflammatory disorders\n * History of primary or acquired immunodeficiency syndrome, history of allogeneic organ transplant that requires therapeutic immunosuppression\n * Received live or attenuated vaccination within 28 days prior to the start of NMA-LD\n * Patients with a history of hypersensitivity to any component of the study drugs\n * Mean QT interval â‰¥ 470 msec\n * Patients who have a left ventricular ejection fraction (LVEF) of < 45% or who are New York Heart Association (NYHA) Class 2 or higher\n * Serious illnesses or medical conditions, which would pose increased risk for study participation and/or compliance with the protocol\n * Patients who have obstructive or restrictive pulmonary disease and have a documented FEV1 (forced expiratory volume in 1 second) of â‰¤ 60%\n * Active central nervous system metastases and/or leptomeningeal disease\n * Female patients who are pregnant or breastfeeding\n * Active infection including tuberculosis (TB), hepatitis B, hepatitis C, or HIV\n * Current or prior use of immunosuppressive medication within 28 days before the first dose of study treatment, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid",{"$nulls":4},"Actual","2018-02-05","Actual","Anticipated","2024-12-01","Anticipated","2018-11-01","2018-01-14","2018-01-26","2018-11-07","Yes","LN-145\nCell Therapy\nAutologous Adoptive Cell Transfer\nCellular Immuno-therapy\nTIL\nIL-2\nDurvalumab","Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":19},"Objective Response Rate|â‰¥ Grade 3 Treatment-Emergent Adverse Event","To evaluate efficacy using the objective response rate (ORR)|To evaluate the safety as measured by any â‰¥ Grade 3 treatment-emergent adverse event (TEAE) rate","A maximum of 24 months","Duration of Response|Progression Free Survival|Overall Survival","To further evaluate efficacy such as the duration of response (DOR)|To further evaluate efficacy such as progression free survival (PFS)|To further evaluate efficacy such as overall survival (OS)","A maximum of 24 months|A minimum of 5 years","clinical.inquiries@iovance.com","Iovance Biotherapeutics Clinical Inquiries","866-565-4410","La Jolla, California, United States, 92093 University Of California, Los Angeles, Santa Monica Hematology/OncologyLos Angeles, California, United States, 90095|Louisville, Kentucky, United States, 40202|Detroit, Michigan, United States, 48201|Morristown, New Jersey, United States, 07960|[Active, Not Recruiting]Portland, Oregon, United States, 97213|Pittsburgh, Pennsylvania, United States, 15232|Nashville, Tennessee, United States, 37232|Seattle, Washington, United States, 98195-0001","California|Kentucky|Michigan|New Jersey|Oregon|Pennsylvania|Tennessee|Washington","United States","University Of California San Diego, Morres Cancer Center|University Of Louisville James Graham Brown Cancer Center|Karmanos Cancer Institute|Morristown Medical Center Atlantic Hematology Oncology|Providence Cancer Center Oncology And Hematology Care Clinic|Upmc Cancer Center|Vanderbilt University|University Of Washington Medical Center",{"$nulls":3},"Iovance Medical Monitor","2018-11-07","2020-05-25T16:40:06.367","2020-05-26T17:10:42.972","NCT03419559"]
["5ecbf4e7e2561b1b11905f00","NCT03419559","2018-12-10","Iovance Biotherapeutics","IOVA","Recruiting","Study of Autologous Tumor Infiltrating Lymphocytes (LN-145) In Combo With Durvalumab in Non-Small Cell Lung Cancer","Ln-145|Durvalumab","PDL-1 Inhibitor","Yes","['Ln-145']","No",null,"Phase 2",1,12,"Anticipated","2018-02-28","2021-12-01","RR","Response Rate",{"$nulls":3},"This study is a Phase 2, open-label, multicenter study evaluating adoptive cell therapy (ACT) with autologous TIL therapy (LN-145) in combination with Anti-PD-L1 inhibitor durvalumab.","LN-145 is an adoptive cell transfer therapy that utilizes an autologous TIL manufacturing process, as originally developed by the NCI. The cell transfer therapy used in this study involves patients receiving a nonmyeloablative (NMA) lymphocyte depleting preparative regimen, followed by infusion of autologous TIL followed by the administration of a regimen of IL-2.","A Phase 2 Study to Assess the Efficacy and Safety of Autologous Tumor Infiltrating Lymphocytes (LN-145) In Combination With Anti-PD-L1 Inhibitor Durvalumab (MEDI4736) in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)","IOV-LUN-201","Non Small Cell Lung Cancer","Lung Cancer|Small Cell Lung Cancer|Non-Small-Cell Lung Cancer","Oncology Solid Tumor","Oncology","Experimental","LN-145 in combination with durvalumab","After nonmyeloablative (NMA) lymphodepletion, patients are infused with their autologous TIL (LN-145) followed by IL-2 administration.","Biological|Drug","LN-145|Durvalumab","adoptive cell therapy (ACT) with autologous TIL therapy|PD-L1 antagonist monoclonal antibody","TIL, autologous tumor infiltrating lymphocytes|MEDI4736","LN-145 in combination with durvalumab","\n\n * Confirmed diagnosis of Stage III or Stage IV NSCLC and progressed after â‰¤ 3 lines of prior systemic therapy in the locally advanced or metastatic setting\n * Have at least 1 lesion resectable for TIL generation\n * Measurable disease as defined by RECIST v1.1\n * Male or female, â‰¥ 18 years of age\n * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and estimated life expectancy of â‰¥ 3 months\n * Adequate bone marrow function at screening\n * Adequate organ function at screening\n * A washout period from prior anticancer therapy(ies) of a minimum duration is required prior to first study treatment\n * Recovered from all prior anticancer therapy-related AEs to Grade 1 or less (per CTCAE v4.03) prior to enrollment\n * Female patients of childbearing potential and male patients with partners of childbearing potential patient must agree to use contraception while on study and during the timeframes as specified following the last dose of study drug(s) received, or until the first dose of the subsequent anticancer therapy, whichever is longer\n * Evidence of postmenopausal status or negative urine or serum pregnancy test for female premenopausal patients\n\n","\n\n * History of other malignancies, except for the following: adequately treated nonmelanoma skin cancer, curatively treated in-situ cancer of the cervix, curatively-treated thyroid cancer, or other solid tumors curatively treated with no evidence of disease for â‰¥ 3 years\n * Patients who have received prior cell therapy\n * Patients who have received prior checkpoint inhibitors: such as anti-PD-1, anti-PD-L1 inhibitors, and durvalumab\n * Active or prior documented autoimmune or inflammatory disorders\n * History of primary or acquired immunodeficiency syndrome, history of allogeneic organ transplant that requires therapeutic immunosuppression\n * Received live or attenuated vaccination within 28 days prior to the start of NMA-LD\n * Patients with a history of hypersensitivity to any component of the study drugs\n * Mean QT interval â‰¥ 470 msec\n * Patients who have a left ventricular ejection fraction (LVEF) of < 45% or who are New York Heart Association (NYHA) Class 2 or higher\n * Serious illnesses or medical conditions, which would pose increased risk for study participation and/or compliance with the protocol\n * Patients who have obstructive or restrictive pulmonary disease and have a documented FEV1 (forced expiratory volume in 1 second) of â‰¤ 60%\n * Active central nervous system metastases and/or leptomeningeal disease\n * Female patients who are pregnant or breastfeeding\n * Active infection including tuberculosis (TB), hepatitis B, hepatitis C, or HIV\n * Current or prior use of immunosuppressive medication within 28 days before the first dose of study treatment, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid",{"$nulls":4},"Actual","2018-02-05","Actual","Anticipated","2024-12-01","Anticipated","2018-12-01","2018-01-14","2018-01-26","2018-12-06","Yes","LN-145\nCell Therapy\nAutologous Adoptive Cell Transfer\nCellular Immuno-therapy\nTIL\nIL-2\nDurvalumab","Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":19},"Objective Response Rate|â‰¥ Grade 3 Treatment-Emergent Adverse Event","To evaluate efficacy using the objective response rate (ORR)|To evaluate the safety as measured by any â‰¥ Grade 3 treatment-emergent adverse event (TEAE) rate","A maximum of 24 months","Duration of Response|Progression Free Survival|Overall Survival","To further evaluate efficacy such as the duration of response (DOR)|To further evaluate efficacy such as progression free survival (PFS)|To further evaluate efficacy such as overall survival (OS)","A maximum of 24 months|A minimum of 5 years","clinical.inquiries@iovance.com","Iovance Biotherapeutics Clinical Inquiries","866-565-4410","La Jolla, California, United States, 92093 University Of California, Los Angeles, Santa Monica Hematology/OncologyLos Angeles, California, United States, 90095|Louisville, Kentucky, United States, 40202|Detroit, Michigan, United States, 48201|Morristown, New Jersey, United States, 07960|[Active, Not Recruiting]Portland, Oregon, United States, 97213|Pittsburgh, Pennsylvania, United States, 15232|Nashville, Tennessee, United States, 37232|Seattle, Washington, United States, 98195-0001","California|Kentucky|Michigan|New Jersey|Oregon|Pennsylvania|Tennessee|Washington","United States","University Of California San Diego, Moores Cancer Center|University Of Louisville James Graham Brown Cancer Center|Karmanos Cancer Institute|Morristown Medical Center Atlantic Hematology Oncology|Providence Cancer Center Oncology And Hematology Care Clinic|Upmc Cancer Center|Vanderbilt University|University Of Washington Medical Center",{"$nulls":3},"Iovance Medical Monitor","2018-12-06","2020-05-25T16:40:07.384","2020-05-26T17:10:42.972","NCT03419559"]
["5ecbf4e7307e3d1b1f8d9e97","NCT03419559","2019-01-08","Iovance Biotherapeutics","IOVA","Recruiting","Study of Autologous Tumor Infiltrating Lymphocytes (LN-145) In Combo With Durvalumab in Non-Small Cell Lung Cancer","Ln-145|Durvalumab","PDL-1 Inhibitor","Yes","['Ln-145']","No",null,"Phase 2",1,12,"Anticipated","2018-02-28","2021-12-01","RR","Response Rate",{"$nulls":3},"This study is a Phase 2, open-label, multicenter study evaluating adoptive cell therapy (ACT) with autologous TIL therapy (LN-145) in combination with Anti-PD-L1 inhibitor durvalumab.","LN-145 is an adoptive cell transfer therapy that utilizes an autologous TIL manufacturing process, as originally developed by the NCI. The cell transfer therapy used in this study involves patients receiving a nonmyeloablative (NMA) lymphocyte depleting preparative regimen, followed by infusion of autologous TIL followed by the administration of a regimen of IL-2.","A Phase 2 Study to Assess the Efficacy and Safety of Autologous Tumor Infiltrating Lymphocytes (LN-145) In Combination With Anti-PD-L1 Inhibitor Durvalumab (MEDI4736) in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)","IOV-LUN-201","Non Small Cell Lung Cancer","Lung Cancer|Small Cell Lung Cancer|Non-Small-Cell Lung Cancer","Oncology Solid Tumor","Oncology","Experimental","LN-145 in combination with durvalumab","After nonmyeloablative (NMA) lymphodepletion, patients are infused with their autologous TIL (LN-145) followed by IL-2 administration.","Biological|Drug","LN-145|Durvalumab","adoptive cell therapy (ACT) with autologous TIL therapy|PD-L1 antagonist monoclonal antibody","TIL, autologous tumor infiltrating lymphocytes|MEDI4736","LN-145 in combination with durvalumab","\n\n * Confirmed diagnosis of Stage III or Stage IV NSCLC and progressed after â‰¤ 3 lines of prior systemic therapy in the locally advanced or metastatic setting\n * Have at least 1 lesion resectable for TIL generation\n * Measurable disease as defined by RECIST v1.1\n * Male or female, â‰¥ 18 years of age\n * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and estimated life expectancy of â‰¥ 3 months\n * Adequate bone marrow function at screening\n * Adequate organ function at screening\n * A washout period from prior anticancer therapy(ies) of a minimum duration is required prior to first study treatment\n * Recovered from all prior anticancer therapy-related AEs to Grade 1 or less (per CTCAE v4.03) prior to enrollment\n * Female patients of childbearing potential and male patients with partners of childbearing potential patient must agree to use contraception while on study and during the timeframes as specified following the last dose of study drug(s) received, or until the first dose of the subsequent anticancer therapy, whichever is longer\n * Evidence of postmenopausal status or negative urine or serum pregnancy test for female premenopausal patients\n\n","\n\n * History of other malignancies, except for the following: adequately treated nonmelanoma skin cancer, curatively treated in-situ cancer of the cervix, curatively-treated thyroid cancer, or other solid tumors curatively treated with no evidence of disease for â‰¥ 3 years\n * Patients who have received prior cell therapy\n * Patients who have received prior checkpoint inhibitors: such as anti-PD-1, anti-PD-L1 inhibitors, and durvalumab\n * Active or prior documented autoimmune or inflammatory disorders\n * History of primary or acquired immunodeficiency syndrome, history of allogeneic organ transplant that requires therapeutic immunosuppression\n * Received live or attenuated vaccination within 28 days prior to the start of NMA-LD\n * Patients with a history of hypersensitivity to any component of the study drugs\n * Mean QT interval â‰¥ 470 msec\n * Patients who have a left ventricular ejection fraction (LVEF) of < 45% or who are New York Heart Association (NYHA) Class 2 or higher\n * Serious illnesses or medical conditions, which would pose increased risk for study participation and/or compliance with the protocol\n * Patients who have obstructive or restrictive pulmonary disease and have a documented FEV1 (forced expiratory volume in 1 second) of â‰¤ 60%\n * Active central nervous system metastases and/or leptomeningeal disease\n * Female patients who are pregnant or breastfeeding\n * Active infection including tuberculosis (TB), hepatitis B, hepatitis C, or HIV\n * Current or prior use of immunosuppressive medication within 28 days before the first dose of study treatment, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid",{"$nulls":4},"Actual","2018-02-05","Actual","Anticipated","2024-12-01","Anticipated","2019-01-01","2018-01-14","2018-01-26","2019-01-04","Yes","LN-145\nCell Therapy\nAutologous Adoptive Cell Transfer\nCellular Immuno-therapy\nTIL\nIL-2\nDurvalumab","Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":19},"Objective Response Rate|â‰¥ Grade 3 Treatment-Emergent Adverse Event","To evaluate efficacy using the objective response rate (ORR)|To evaluate the safety as measured by any â‰¥ Grade 3 treatment-emergent adverse event (TEAE) rate","A maximum of 24 months","Duration of Response|Progression Free Survival|Overall Survival","To further evaluate efficacy such as the duration of response (DOR)|To further evaluate efficacy such as progression free survival (PFS)|To further evaluate efficacy such as overall survival (OS)","A maximum of 24 months|A minimum of 5 years","clinical.inquiries@iovance.com","Iovance Biotherapeutics Clinical Inquiries","866-565-4410","La Jolla, California, United States, 92093 University Of California, Los Angeles, Santa Monica Hematology/OncologyLos Angeles, California, United States, 90095|Louisville, Kentucky, United States, 40202|Detroit, Michigan, United States, 48201|Morristown, New Jersey, United States, 07960|Pittsburgh, Pennsylvania, United States, 15232|Nashville, Tennessee, United States, 37232|Seattle, Washington, United States, 98195-0001","California|Kentucky|Michigan|New Jersey|Pennsylvania|Tennessee|Washington","United States","University Of California San Diego, Moores Cancer Center|University Of Louisville James Graham Brown Cancer Center|Karmanos Cancer Institute|Morristown Medical Center Atlantic Hematology Oncology|Upmc Cancer Center|Vanderbilt University|University Of Washington Medical Center",{"$nulls":3},"Iovance Medical Monitor","2019-01-04","2020-05-25T16:40:07.692","2020-05-26T17:10:42.972","NCT03419559"]
["5ecbf4e7307e3d1b1f8d9e96","NCT03419559","2019-04-16","Iovance Biotherapeutics","IOVA","Withdrawn","Study of Autologous Tumor Infiltrating Lymphocytes (LN-145) In Combo With Durvalumab in Non-Small Cell Lung Cancer","Ln-145|Durvalumab","PDL-1 Inhibitor","Yes","['Ln-145']","No",null,"Phase 2",1,0,"Actual","2018-02-28","2021-12-01","RR","Response Rate",{"$nulls":3},"This study is a Phase 2, open-label, multicenter study evaluating adoptive cell therapy (ACT) with autologous TIL therapy (LN-145) in combination with Anti-PD-L1 inhibitor durvalumab.","LN-145 is an adoptive cell transfer therapy that utilizes an autologous TIL manufacturing process, as originally developed by the NCI. The cell transfer therapy used in this study involves patients receiving a nonmyeloablative (NMA) lymphocyte depleting preparative regimen, followed by infusion of autologous TIL followed by the administration of a regimen of IL-2.","A Phase 2 Study to Assess the Efficacy and Safety of Autologous Tumor Infiltrating Lymphocytes (LN-145) In Combination With Anti-PD-L1 Inhibitor Durvalumab (MEDI4736) in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)","IOV-LUN-201","Non Small Cell Lung Cancer","Lung Cancer|Small Cell Lung Cancer|Non-Small-Cell Lung Cancer","Oncology Solid Tumor","Oncology","Experimental","LN-145 in combination with durvalumab","After nonmyeloablative (NMA) lymphodepletion, patients are infused with their autologous TIL (LN-145) followed by IL-2 administration.","Biological|Drug","LN-145|Durvalumab","adoptive cell therapy (ACT) with autologous TIL therapy|PD-L1 antagonist monoclonal antibody","TIL, autologous tumor infiltrating lymphocytes|MEDI4736","LN-145 in combination with durvalumab","\n\n * Confirmed diagnosis of Stage III or Stage IV NSCLC and progressed after â‰¤ 3 lines of prior systemic therapy in the locally advanced or metastatic setting\n * Have at least 1 lesion resectable for TIL generation\n * Measurable disease as defined by RECIST v1.1\n * Male or female, â‰¥ 18 years of age\n * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and estimated life expectancy of â‰¥ 3 months\n * Adequate bone marrow function at screening\n * Adequate organ function at screening\n * A washout period from prior anticancer therapy(ies) of a minimum duration is required prior to first study treatment\n * Recovered from all prior anticancer therapy-related AEs to Grade 1 or less (per CTCAE v4.03) prior to enrollment\n * Female patients of childbearing potential and male patients with partners of childbearing potential patient must agree to use contraception while on study and during the timeframes as specified following the last dose of study drug(s) received, or until the first dose of the subsequent anticancer therapy, whichever is longer\n * Evidence of postmenopausal status or negative urine or serum pregnancy test for female premenopausal patients\n\n","\n\n * History of other malignancies, except for the following: adequately treated nonmelanoma skin cancer, curatively treated in-situ cancer of the cervix, curatively-treated thyroid cancer, or other solid tumors curatively treated with no evidence of disease for â‰¥ 3 years\n * Patients who have received prior cell therapy\n * Patients who have received prior checkpoint inhibitors: such as anti-PD-1, anti-PD-L1 inhibitors, and durvalumab\n * Active or prior documented autoimmune or inflammatory disorders\n * History of primary or acquired immunodeficiency syndrome, history of allogeneic organ transplant that requires therapeutic immunosuppression\n * Received live or attenuated vaccination within 28 days prior to the start of NMA-LD\n * Patients with a history of hypersensitivity to any component of the study drugs\n * Mean QT interval â‰¥ 470 msec\n * Patients who have a left ventricular ejection fraction (LVEF) of < 45% or who are New York Heart Association (NYHA) Class 2 or higher\n * Serious illnesses or medical conditions, which would pose increased risk for study participation and/or compliance with the protocol\n * Patients who have obstructive or restrictive pulmonary disease and have a documented FEV1 (forced expiratory volume in 1 second) of â‰¤ 60%\n * Active central nervous system metastases and/or leptomeningeal disease\n * Female patients who are pregnant or breastfeeding\n * Active infection including tuberculosis (TB), hepatitis B, hepatitis C, or HIV\n * Current or prior use of immunosuppressive medication within 28 days before the first dose of study treatment, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid",{"$nulls":4},"Actual","2018-02-05","Actual","Anticipated","2024-12-01","Anticipated","2019-04-01","2018-01-14","2018-01-26","2019-04-11","Yes","LN-145\nCell Therapy\nAutologous Adoptive Cell Transfer\nCellular Immuno-therapy\nTIL\nIL-2\nDurvalumab","Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No","No",{"$nulls":3},"Yes","No",{"$nulls":19},"Objective Response Rate|â‰¥ Grade 3 Treatment-Emergent Adverse Event","To evaluate efficacy using the objective response rate (ORR)|To evaluate the safety as measured by any â‰¥ Grade 3 treatment-emergent adverse event (TEAE) rate","A maximum of 24 months","Duration of Response|Progression Free Survival|Overall Survival","To further evaluate efficacy such as the duration of response (DOR)|To further evaluate efficacy such as progression free survival (PFS)|To further evaluate efficacy such as overall survival (OS)","A maximum of 24 months|A minimum of 5 years",{"$nulls":3},"La Jolla, California, United States, 92093 University Of California, Los Angeles, Santa Monica Hematology/OncologyLos Angeles, California, United States, 90095|Louisville, Kentucky, United States, 40202|Detroit, Michigan, United States, 48201|Morristown, New Jersey, United States, 07960|Pittsburgh, Pennsylvania, United States, 15232|Nashville, Tennessee, United States, 37232|Seattle, Washington, United States, 98195-0001","California|Kentucky|Michigan|New Jersey|Pennsylvania|Tennessee|Washington","United States","University Of California San Diego, Moores Cancer Center|University Of Louisville James Graham Brown Cancer Center|Karmanos Cancer Institute|Morristown Medical Center Atlantic Hematology Oncology|Upmc Cancer Center|Vanderbilt University|University Of Washington Medical Center",{"$nulls":3},"Iovance Medical Monitor","2019-04-11","2020-05-25T16:40:07.383","2020-05-26T17:10:42.972","NCT03419559"]
["5ecbf4e911702c1b1b916c17","NCT03419897","2018-02-05","BeiGene","BGNE","Not yet recruiting","Study of BGB-A317 in Patients With Previously Treated Unresectable HCC","Tislelizumab","PD-1 Inhibitor","Yes","['Tislelizumab']","No",null,"Phase 2",1,228,"Anticipated","2018-02-28","2021-03-01","RR","Response Rate",{"$nulls":3},"This is a Phase 2, Open-label, Multicenter Study to Investigate the Efficacy, Safety, and Pharmacokinetics of the Anti-PD-1 Monoclonal Antibody BGB-A317 in Patients with Previously Treated Hepatocellular Unresectable Carcinoma.",null,"A Phase 2, Open-label, Multicenter Study to Investigate the Efficacy, Safety, and Pharmacokinetics of the Anti-PD-1 Monoclonal Antibody BGB-A317 in Patients With Previously Treated Hepatocellular Unresectable Carcinoma","BGB-A317-208","Hepatocellular Carcinoma (HCC)","Noma|Carcinoma|Hepatocellular Carcinoma","Mouth Diseases|Oncology Solid Tumor","Ear, Nose and Throat|Oncology","Experimental","BGB-A317","BGB-A317: 200 mg once every 3 weeks (Q3W), intravenous dosing (IV)","Drug","BGB-A317","Anti-PD-1 ANTIBODY",null,"BGB-A317","\n\n 1. Histologically confirmed HCC\n 2. Patients with Barcelona Clinic Liver Cancer (BCLC) Stage C, or BCLC stage B not amenable to locoregional therapy or relapsed after locoregional therapy, and not amenable to a curative treatment approach\n 3. Has received at least 1 line of systemic therapy for unresectable HCC\n 4. Has at least 1 measurable lesion as defined per RECIST v1.1\n 5. Child-Pugh score A\n 6. Easter Cooperative Oncology Group (ECOG) Performance Status â‰¤ 1\n 7. Adequate organ function\n\n","\n\n 1. Histologically confirmed HCC\n 2. Patients with Barcelona Clinic Liver Cancer (BCLC) Stage C, or BCLC stage B not amenable to locoregional therapy or relapsed after locoregional therapy, and not amenable to a curative treatment approach\n 3. Has received at least 1 line of systemic therapy for unresectable HCC\n 4. Has at least 1 measurable lesion as defined per RECIST v1.1\n 5. Child-Pugh score A\n 6. Easter Cooperative Oncology Group (ECOG) Performance Status â‰¤ 1\n 7. Adequate organ function",{"$nulls":4},"Actual","2018-02-05","Actual","Anticipated","2021-09-01","Anticipated","2018-01-01","2018-01-29","2018-02-01","2018-02-01","Yes","Advanced liver cancer","Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No","Undecided",{"$nulls":3},"Yes","No",{"$nulls":19},"Objective Response Rate (ORR) assessed by Independent Review Committee (IRC)","From date of enrollment up to 4 years, approximately",null,"Duration of Response (DOR)|Progression-free survival (PFS)|Disease Control Rate (DCR)|Clinical benefit rate (CBR)|Overall Survival|Percentage of patients with adverse events|Health-Related Quality of Life (HRQoL)|Percentage of Participants With Clinically Significant Changes in Vital Signs Findings|Percentage of Participants With Clinically Significant Changes in Physical Examination Findings|Percentage of Participants With Clinically Significant Changes in Clinical Laboratory Results Findings|Percentage of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Findings","From first determination of an objective response up to 4 years, approximately|From date of enrollment up to 4 years, approximately|From first dose of study treatment up to 4 years, approximately|From first dose of study treatment up to 4 years, approximately.|From date of enrollment up to 4 years, approximately.|At screening or baseline up to 4 years, approximately",{"$nulls":12},"2018-02-01","2020-05-25T16:40:09.622","2020-05-26T17:10:42.972","NCT03419897"]
["5ecbf4e911702c1b1b916c16","NCT03419897","2018-02-07","BeiGene","BGNE","Not yet recruiting","Study of BGB-A317 in Patients With Previously Treated Unresectable HCC","Tislelizumab","PD-1 Inhibitor","Yes","['Tislelizumab']","No",null,"Phase 2",1,228,"Anticipated","2018-02-28","2021-03-01","RR","Response Rate",{"$nulls":3},"This is a Phase 2, Open-label, Multicenter Study to Investigate the Efficacy, Safety, and Pharmacokinetics of the Anti-PD-1 Monoclonal Antibody BGB-A317 in Patients with Previously Treated Hepatocellular Unresectable Carcinoma.",null,"A Phase 2, Open-label, Multicenter Study to Investigate the Efficacy, Safety, and Pharmacokinetics of the Anti-PD-1 Monoclonal Antibody BGB-A317 in Patients With Previously Treated Hepatocellular Unresectable Carcinoma","BGB-A317-208","Hepatocellular Carcinoma (HCC)","Noma|Carcinoma|Hepatocellular Carcinoma","Mouth Diseases|Oncology Solid Tumor","Ear, Nose and Throat|Oncology","Experimental","BGB-A317","BGB-A317: 200 mg once every 3 weeks (Q3W), intravenous dosing (IV)","Drug","BGB-A317","Anti-PD-1 ANTIBODY",null,"BGB-A317","\n\n 1. Histologically confirmed HCC\n 2. Patients with Barcelona Clinic Liver Cancer (BCLC) Stage C, or BCLC stage B not amenable to locoregional therapy or relapsed after locoregional therapy, and not amenable to a curative treatment approach\n 3. Has received at least 1 line of systemic therapy for unresectable HCC\n 4. Has at least 1 measurable lesion as defined per RECIST v1.1\n 5. Child-Pugh score A\n 6. Easter Cooperative Oncology Group (ECOG) Performance Status â‰¤ 1\n 7. Adequate organ function\n\n","\n\n 1. Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC histology\n 2. Prior therapies targeting PD-1 or PD-L1\n 3. Has Known brain or leptomeningeal metastasis\n 4. Tumor thrombus involving main trunk of portal vein or inferior vena cava\n 5. Loco-regional therapy to the liver within 4 weeks before enrollment\n 6. Medical history of interstitial lung disease, non-infectious pneumonitis or uncontrolled systemic diseases, including diabetes, hypertension, pulmonary fibrosis, acute lung diseases, etc\n 7. Has received: 1. Within 28 days or 5 half-lives (whichever is shorter) of the first study drug administration: any chemotherapy, immunotherapy (eg, interleukin, interferon, thymoxin) or any investigational therapies\n     2. Within 14 days of the first study drug administration: sorafenib, regorafenib, or any Chinese herbal medicine or Chinese patent medicines used to control cancer\n    \n    \n 8. Active autoimmune diseases or history of autoimmune diseases that may relapse\n 9. Patient with any condition requiring systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication within 14 days before study drug administration",{"$nulls":4},"Actual","2018-02-05","Actual","Anticipated","2021-09-01","Anticipated","2018-02-01","2018-01-29","2018-02-01","2018-02-06","Yes","Advanced liver cancer","Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No","Undecided",{"$nulls":3},"Yes","No",{"$nulls":19},"Objective Response Rate (ORR) assessed by Independent Review Committee (IRC)","From date of enrollment up to 4 years, approximately",null,"Duration of Response (DOR)|Progression-free survival (PFS)|Disease Control Rate (DCR)|Clinical benefit rate (CBR)|Overall Survival|Percentage of patients with adverse events|Health-Related Quality of Life (HRQoL)|Percentage of Participants With Clinically Significant Changes in Vital Signs Findings|Percentage of Participants With Clinically Significant Changes in Physical Examination Findings|Percentage of Participants With Clinically Significant Changes in Clinical Laboratory Results Findings|Percentage of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Findings","From first determination of an objective response up to 4 years, approximately|From date of enrollment up to 4 years, approximately|From first dose of study treatment up to 4 years, approximately|From first dose of study treatment up to 4 years, approximately.|From date of enrollment up to 4 years, approximately.|At screening or baseline up to 4 years, approximately",{"$nulls":12},"2018-02-06","2020-05-25T16:40:09.221","2020-05-26T17:10:42.972","NCT03419897"]
["5ecbf4e9fe30261b1a04840a","NCT03419897","2018-05-16","BeiGene","BGNE","Recruiting","Study of BGB-A317 in Patients With Previously Treated Unresectable HCC","Tislelizumab","PD-1 Inhibitor","Yes","['Tislelizumab']","No",null,"Phase 2",1,228,"Anticipated","2018-04-09","2021-03-01","RR","Response Rate",{"$nulls":3},"This is a Phase 2, Open-label, Multicenter Study to Investigate the Efficacy, Safety, and Pharmacokinetics of the Anti-PD-1 Monoclonal Antibody BGB-A317 in Patients with Previously Treated Hepatocellular Unresectable Carcinoma.",null,"A Phase 2, Open-label, Multicenter Study to Investigate the Efficacy, Safety, and Pharmacokinetics of the Anti-PD-1 Monoclonal Antibody BGB-A317 in Patients With Previously Treated Hepatocellular Unresectable Carcinoma","BGB-A317-208","Hepatocellular Carcinoma (HCC)","Noma|Carcinoma|Hepatocellular Carcinoma","Mouth Diseases|Oncology Solid Tumor","Ear, Nose and Throat|Oncology","Experimental","BGB-A317","BGB-A317: 200 mg once every 3 weeks (Q3W), intravenous dosing (IV)","Drug","BGB-A317","Anti-PD-1 ANTIBODY",null,"BGB-A317","\n\n 1. Histologically confirmed HCC\n 2. Patients with Barcelona Clinic Liver Cancer (BCLC) Stage C, or BCLC stage B not amenable to locoregional therapy or relapsed after locoregional therapy, and not amenable to a curative treatment approach\n 3. Has received at least 1 line of systemic therapy for unresectable HCC\n 4. Has at least 1 measurable lesion as defined per RECIST v1.1\n 5. Child-Pugh score A\n 6. Easter Cooperative Oncology Group (ECOG) Performance Status â‰¤ 1\n 7. Adequate organ function\n\n","\n\n 1. Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC histology\n 2. Prior therapies targeting PD-1 or PD-L1\n 3. Has Known brain or leptomeningeal metastasis\n 4. Tumor thrombus involving main trunk of portal vein or inferior vena cava\n 5. Loco-regional therapy to the liver within 4 weeks before enrollment\n 6. Medical history of interstitial lung disease, non-infectious pneumonitis or uncontrolled systemic diseases, including diabetes, hypertension, pulmonary fibrosis, acute lung diseases, etc\n 7. Has received: 1. Within 28 days or 5 half-lives (whichever is shorter) of the first study drug administration: any chemotherapy, immunotherapy (eg, interleukin, interferon, thymoxin) or any investigational therapies\n     2. Within 14 days of the first study drug administration: sorafenib, regorafenib, or any Chinese herbal medicine or Chinese patent medicines used to control cancer\n    \n    \n 8. Active autoimmune diseases or history of autoimmune diseases that may relapse\n 9. Patient with any condition requiring systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication within 14 days before study drug administration",{"$nulls":4},"Actual","2018-02-05","Actual","Anticipated","2021-09-01","Anticipated","2018-05-01","2018-01-29","2018-02-01","2018-05-15","Yes","Advanced liver cancer","Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No","Undecided",{"$nulls":3},"Yes","No",{"$nulls":19},"Objective Response Rate (ORR) assessed by Independent Review Committee (IRC)","From date of enrollment up to 4 years, approximately",null,"Duration of Response (DOR)|Progression-free survival (PFS)|Disease Control Rate (DCR)|Clinical benefit rate (CBR)|Overall Survival|Percentage of patients with adverse events|Health-Related Quality of Life (HRQoL)|Percentage of Participants With Clinically Significant Changes in Vital Signs Findings|Percentage of Participants With Clinically Significant Changes in Physical Examination Findings|Percentage of Participants With Clinically Significant Changes in Clinical Laboratory Results Findings|Percentage of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Findings","From first determination of an objective response up to 4 years, approximately|From date of enrollment up to 4 years, approximately|From first dose of study treatment up to 4 years, approximately|From first dose of study treatment up to 4 years, approximately.|From date of enrollment up to 4 years, approximately.|At screening or baseline up to 4 years, approximately",{"$nulls":4},"Xuzhou, Jiangsu Province, P.R., China, 221009",null,"China","Jiangsu Province, P.R. Xuzhou Central Hospital",{"$nulls":4},"2018-05-15","2020-05-25T16:40:09.348","2020-05-26T17:10:42.972","NCT03419897"]
["5ecbf4e9e2561b1b11905f06","NCT03419897","2018-06-08","BeiGene","BGNE","Recruiting","Study of BGB-A317 in Patients With Previously Treated Unresectable HCC","Tislelizumab","PD-1 Inhibitor","Yes","['Tislelizumab']","No",null,"Phase 2",1,228,"Anticipated","2018-04-09","2021-03-01","RR","Response Rate",{"$nulls":3},"This is a Phase 2, Open-label, Multicenter Study to Investigate the Efficacy, Safety, and Pharmacokinetics of the Anti-PD-1 Monoclonal Antibody BGB-A317 in Patients with Previously Treated Hepatocellular Unresectable Carcinoma.",null,"A Phase 2, Open-label, Multicenter Study to Investigate the Efficacy, Safety, and Pharmacokinetics of the Anti-PD-1 Monoclonal Antibody BGB-A317 in Patients With Previously Treated Hepatocellular Unresectable Carcinoma","BGB-A317-208","Hepatocellular Carcinoma (HCC)","Noma|Carcinoma|Hepatocellular Carcinoma","Mouth Diseases|Oncology Solid Tumor","Ear, Nose and Throat|Oncology","Experimental","BGB-A317","BGB-A317: 200 mg once every 3 weeks (Q3W), intravenous dosing (IV)","Drug","BGB-A317","Anti-PD-1 ANTIBODY",null,"BGB-A317","\n\n 1. Histologically confirmed HCC\n 2. Patients with Barcelona Clinic Liver Cancer (BCLC) Stage C, or BCLC stage B not amenable to locoregional therapy or relapsed after locoregional therapy, and not amenable to a curative treatment approach\n 3. Has received at least 1 line of systemic therapy for unresectable HCC\n 4. Has at least 1 measurable lesion as defined per RECIST v1.1\n 5. Child-Pugh score A\n 6. Easter Cooperative Oncology Group (ECOG) Performance Status â‰¤ 1\n 7. Adequate organ function\n\n","\n\n 1. Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC histology\n 2. Prior therapies targeting PD-1 or PD-L1\n 3. Has Known brain or leptomeningeal metastasis\n 4. Tumor thrombus involving main trunk of portal vein or inferior vena cava\n 5. Loco-regional therapy to the liver within 4 weeks before enrollment\n 6. Medical history of interstitial lung disease, non-infectious pneumonitis or uncontrolled systemic diseases, including diabetes, hypertension, pulmonary fibrosis, acute lung diseases, etc\n 7. Has received: 1. Within 28 days or 5 half-lives (whichever is shorter) of the first study drug administration: any chemotherapy, immunotherapy (eg, interleukin, interferon, thymoxin) or any investigational therapies\n     2. Within 14 days of the first study drug administration: sorafenib, regorafenib, or any Chinese herbal medicine or Chinese patent medicines used to control cancer\n    \n    \n 8. Active autoimmune diseases or history of autoimmune diseases that may relapse\n 9. Patient with any condition requiring systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication within 14 days before study drug administration",{"$nulls":4},"Actual","2018-02-05","Actual","Anticipated","2021-09-01","Anticipated","2018-06-01","2018-01-29","2018-02-01","2018-06-06","Yes","Advanced liver cancer","Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No","Undecided",{"$nulls":3},"Yes","No",{"$nulls":19},"Objective Response Rate (ORR) assessed by Independent Review Committee (IRC)","From date of enrollment up to 4 years, approximately",null,"Duration of Response (DOR)|Progression-free survival (PFS)|Disease Control Rate (DCR)|Clinical benefit rate (CBR)|Overall Survival|Percentage of patients with adverse events|Health-Related Quality of Life (HRQoL)|Percentage of Participants With Clinically Significant Changes in Vital Signs Findings|Percentage of Participants With Clinically Significant Changes in Physical Examination Findings|Percentage of Participants With Clinically Significant Changes in Clinical Laboratory Results Findings|Percentage of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Findings","From first determination of an objective response up to 4 years, approximately|From date of enrollment up to 4 years, approximately|From first dose of study treatment up to 4 years, approximately|From first dose of study treatment up to 4 years, approximately.|From date of enrollment up to 4 years, approximately.|At screening or baseline up to 4 years, approximately",{"$nulls":4},"Beijing, China, 100853|Guangzhou, Guangdong, China, 510515|Harbin, Heilongjiang, China, 150081|Wuhan, Hubei, China, 430022 Hubei Cancer HospitalWuhan, Hubei, China, 430079|Xuzhou, Jiangsu, China, 221009|Weifang, Shandong, China, 261041|Shanghai, Shanghai, China, 200032|Hangzhou, Zhejiang, China, 310003Principal Investigator: Weijia Fang, The First Affiliated Hospital, Zhejiang UniversityHangzhou, Zhejiang, China, 310003Principal Investigator: Sheng Yan Zhejiang Cancer HospitalHangzhou, Zhejiang, China, 310022 The First Affiliated Hospital Of Wenzhou Medical UniversityWenzhou, Zhejiang, China, 00000|Pessac Cedex, Gironde, France, 33604|Montpellier, Herault, France, 34090|Rennes Cedex, Ille Et Vilaine, France, 35042|Lyon, Rhone, France, 69004|Rozzano, Milano, Italy, 20089|Kettering, Ohio, United States, 45409","Ohio","China|France|Italy|United States","Chinese Pla General Hospital Medical School Of Chinese Pla|Guangdong Nanfang Hospital Of Southern Medical University|Heilongjiang Harbin Medical University Cancer Hospital|Hubei Union Hospital Tongji Medical College Huazhong University Of Science And Technology|Jiangsu Xuzhou Central Hospital|Shandong Weifang People's Hospital|Shanghai Zhongshan Hospital Fudan University|Zhejiang The First Affiliated Hospital, Zhejiang University|Gironde Groupe Hospitalier Sud - HÃ´pital Haut LÃ©vÃªque|Herault Hopital Saint Eloi|Ille Et Vilaine Crlcc Eugene Marquis|Rhone Centre Hospitalier De La Croix Rousse|Milano Istituto Clinico Humanitas|Dayton Oncology & Hematology, P.A.",{"$nulls":4},"2018-06-06","2020-05-25T16:40:09.854","2020-05-26T17:10:42.972","NCT03419897"]
["5ecbf4e9307e3d1b1f8d9e9b","NCT03419897","2018-06-29","BeiGene","BGNE","Recruiting","Study of BGB-A317 in Patients With Previously Treated Unresectable HCC","Tislelizumab","PD-1 Inhibitor","Yes","['Tislelizumab']","No",null,"Phase 2",1,228,"Anticipated","2018-04-09","2021-03-01","RR","Response Rate",{"$nulls":3},"This is a Phase 2, Open-label, Multicenter Study to Investigate the Efficacy, Safety, and Pharmacokinetics of the Anti-PD-1 Monoclonal Antibody BGB-A317 in Patients with Previously Treated Hepatocellular Unresectable Carcinoma.",null,"A Phase 2, Open-label, Multicenter Study to Investigate the Efficacy, Safety, and Pharmacokinetics of the Anti-PD-1 Monoclonal Antibody BGB-A317 in Patients With Previously Treated Hepatocellular Unresectable Carcinoma","BGB-A317-208","Hepatocellular Carcinoma (HCC)","Noma|Carcinoma|Hepatocellular Carcinoma","Mouth Diseases|Oncology Solid Tumor","Ear, Nose and Throat|Oncology","Experimental","BGB-A317","BGB-A317: 200 mg once every 3 weeks (Q3W), intravenous dosing (IV)","Drug","BGB-A317","Anti-PD-1 ANTIBODY",null,"BGB-A317","\n\n 1. Histologically confirmed HCC\n 2. Patients with Barcelona Clinic Liver Cancer (BCLC) Stage C, or BCLC stage B not amenable to locoregional therapy or relapsed after locoregional therapy, and not amenable to a curative treatment approach\n 3. Has received at least 1 line of systemic therapy for unresectable HCC\n 4. Has at least 1 measurable lesion as defined per RECIST v1.1\n 5. Child-Pugh score A\n 6. Easter Cooperative Oncology Group (ECOG) Performance Status â‰¤ 1\n 7. Adequate organ function\n\n","\n\n 1. Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC histology\n 2. Prior therapies targeting PD-1 or PD-L1\n 3. Has Known brain or leptomeningeal metastasis\n 4. Tumor thrombus involving main trunk of portal vein or inferior vena cava\n 5. Loco-regional therapy to the liver within 4 weeks before enrollment\n 6. Medical history of interstitial lung disease, non-infectious pneumonitis or uncontrolled systemic diseases, including diabetes, hypertension, pulmonary fibrosis, acute lung diseases, etc\n 7. Has received: 1. Within 28 days or 5 half-lives (whichever is shorter) of the first study drug administration: any chemotherapy, immunotherapy (eg, interleukin, interferon, thymoxin) or any investigational therapies\n     2. Within 14 days of the first study drug administration: sorafenib, regorafenib, or any Chinese herbal medicine or Chinese patent medicines used to control cancer\n    \n    \n 8. Active autoimmune diseases or history of autoimmune diseases that may relapse\n 9. Patient with any condition requiring systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication within 14 days before study drug administration",{"$nulls":4},"Actual","2018-02-05","Actual","Anticipated","2021-09-01","Anticipated","2018-06-01","2018-01-29","2018-02-01","2018-06-27","Yes","Advanced liver cancer","Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No","Undecided",{"$nulls":3},"Yes","No",{"$nulls":19},"Objective Response Rate (ORR) assessed by Independent Review Committee (IRC)","From date of enrollment up to 4 years, approximately",null,"Duration of Response (DOR)|Progression-free survival (PFS)|Disease Control Rate (DCR)|Clinical benefit rate (CBR)|Overall Survival|Percentage of patients with adverse events|Health-Related Quality of Life (HRQoL)|Percentage of Participants With Clinically Significant Changes in Vital Signs Findings|Percentage of Participants With Clinically Significant Changes in Physical Examination Findings|Percentage of Participants With Clinically Significant Changes in Clinical Laboratory Results Findings|Percentage of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Findings","From first determination of an objective response up to 4 years, approximately|From date of enrollment up to 4 years, approximately|From first dose of study treatment up to 4 years, approximately|From first dose of study treatment up to 4 years, approximately.|From date of enrollment up to 4 years, approximately.|At screening or baseline up to 4 years, approximately",{"$nulls":4},"Beijing, China, 100853|Guangzhou, Guangdong, China, 510515|Harbin, Heilongjiang, China, 150081|Wuhan, Hubei, China, 430022 Hubei Cancer HospitalWuhan, Hubei, China, 430079|Xuzhou, Jiangsu, China, 221009|Weifang, Shandong, China, 261041|Shanghai, Shanghai, China, 200032|Hangzhou, Zhejiang, China, 310003Principal Investigator: Weijia Fang, The First Affiliated Hospital, Zhejiang UniversityHangzhou, Zhejiang, China, 310003Principal Investigator: Sheng Yan Zhejiang Cancer HospitalHangzhou, Zhejiang, China, 310022 The First Affiliated Hospital Of Wenzhou Medical UniversityWenzhou, Zhejiang, China, 00000|Pessac Cedex, Gironde, France, 33604|Montpellier, Herault, France, 34090|Rennes Cedex, Ille Et Vilaine, France, 35042|Lyon, Rhone, France, 69004|Rozzano, Milano, Italy, 20089|Kettering, Ohio, United States, 45409","Ohio","China|France|Italy|United States","Chinese Pla General Hospital Medical School Of Chinese Pla|Guangdong Nanfang Hospital Of Southern Medical University|Heilongjiang Harbin Medical University Cancer Hospital|Hubei Union Hospital Tongji Medical College Huazhong University Of Science And Technology|Jiangsu Xuzhou Central Hospital|Shandong Weifang People's Hospital|Shanghai Zhongshan Hospital Fudan University|Zhejiang The First Affiliated Hospital, Zhejiang University|Gironde Groupe Hospitalier Sud - HÃ´pital Haut LÃ©vÃªque|Herault Hopital Saint Eloi|Ille Et Vilaine Crlcc Eugene Marquis|Rhone Centre Hospitalier De La Croix Rousse|Milano Istituto Clinico Humanitas|Dayton Oncology & Hematology, P.A.",{"$nulls":4},"2018-06-27","2020-05-25T16:40:09.227","2020-05-26T17:10:42.972","NCT03419897"]
["5ecbf4e9feab101b15530a3a","NCT03419897","2018-12-17","BeiGene","BGNE","Recruiting","Study of BGB-A317 in Patients With Previously Treated Unresectable HCC","Tislelizumab","PD-1 Inhibitor","Yes","['Tislelizumab']","No",null,"Phase 2",1,228,"Anticipated","2018-04-09","2021-03-01","RR","Response Rate",{"$nulls":3},"This is a Phase 2, Open-label, Multicenter Study to Investigate the Efficacy, Safety, and Pharmacokinetics of the Anti-PD-1 Monoclonal Antibody BGB-A317 in Patients with Previously Treated Hepatocellular Unresectable Carcinoma.",null,"A Phase 2, Open-label, Multicenter Study to Investigate the Efficacy, Safety, and Pharmacokinetics of the Anti-PD-1 Monoclonal Antibody BGB-A317 in Patients With Previously Treated Hepatocellular Unresectable Carcinoma","BGB-A317-208","Hepatocellular Carcinoma (HCC)","Noma|Carcinoma|Hepatocellular Carcinoma","Mouth Diseases|Oncology Solid Tumor","Ear, Nose and Throat|Oncology","Experimental","BGB-A317","BGB-A317: 200 mg once every 3 weeks (Q3W), intravenous dosing (IV)","Drug","BGB-A317","Anti-PD-1 ANTIBODY",null,"BGB-A317","\n\n 1. Histologically confirmed HCC\n 2. Patients with Barcelona Clinic Liver Cancer (BCLC) Stage C, or BCLC stage B not amenable to locoregional therapy or relapsed after locoregional therapy, and not amenable to a curative treatment approach\n 3. Has received at least 1 line of systemic therapy for unresectable HCC\n 4. Has at least 1 measurable lesion as defined per RECIST v1.1\n 5. Child-Pugh score A\n 6. Easter Cooperative Oncology Group (ECOG) Performance Status â‰¤ 1\n 7. Adequate organ function\n\n","\n\n 1. Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC histology\n 2. Prior therapies targeting PD-1 or PD-L1\n 3. Has Known brain or leptomeningeal metastasis\n 4. Tumor thrombus involving main trunk of portal vein or inferior vena cava\n 5. Loco-regional therapy to the liver within 4 weeks before enrollment\n 6. Medical history of interstitial lung disease, non-infectious pneumonitis or uncontrolled systemic diseases, including diabetes, hypertension, pulmonary fibrosis, acute lung diseases, etc\n 7. Has received: 1. Within 28 days or 5 half-lives (whichever is shorter) of the first study drug administration: any chemotherapy, immunotherapy (eg, interleukin, interferon, thymoxin) or any investigational therapies\n     2. Within 14 days of the first study drug administration: sorafenib, regorafenib, or any Chinese herbal medicine or Chinese patent medicines used to control cancer\n    \n    \n 8. Active autoimmune diseases or history of autoimmune diseases that may relapse\n 9. Patient with any condition requiring systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication within 14 days before study drug administration",{"$nulls":4},"Actual","2018-02-05","Actual","Anticipated","2021-09-01","Anticipated","2018-12-01","2018-01-29","2018-02-01","2018-12-14","Yes","Advanced liver cancer","Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No","Undecided",{"$nulls":3},"Yes","No",{"$nulls":19},"Objective Response Rate (ORR) assessed by Independent Review Committee (IRC)","From date of enrollment up to 4 years, approximately",null,"Duration of Response (DOR)|Progression-free survival (PFS)|Disease Control Rate (DCR)|Clinical benefit rate (CBR)|Overall Survival|Percentage of patients with adverse events|Health-Related Quality of Life (HRQoL)|Percentage of Participants With Clinically Significant Changes in Vital Signs Findings|Percentage of Participants With Clinically Significant Changes in Physical Examination Findings|Percentage of Participants With Clinically Significant Changes in Clinical Laboratory Results Findings|Percentage of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Findings","From first determination of an objective response up to 4 years, approximately|From date of enrollment up to 4 years, approximately|From first dose of study treatment up to 4 years, approximately|From first dose of study treatment up to 4 years, approximately.|From date of enrollment up to 4 years, approximately.|At screening or baseline up to 4 years, approximately",null,"clinicaltrials@beigene.com","Jeannie Hou, Senior Director","1 (877) 828-5568","Hefei, Anhui, China, 230071Principal Investigator: Yueyin Pan Anhui Provincial HospitalHefei, Anhui, China, 230071Principal Investigator: Yueyin Pan The Second Hospital Of Anhui Medical HospitalHefei, Anhui, China, 230601Principal Investigator: Zhendong Chen|Beijing, China, 100853Principal Investigator: Li Bai|Fuzhou, Fujian, China, 350001Principal Investigator: Xiaoyan Lin|Guangzhou, Guangdong, China, 510288Principal Investigator: Yajin Chen Nanfang Hospital Of Southern Medical UniversityGuangzhou, Guangdong, China, 510515Principal Investigator: Jinlin Hou Peking University Shenzhen HospitalShenzhen, Guangdong, China, 518036Principal Investigator: Junhui Chen|Harbin, Heilongjiang, China, 150081Principal Investigator: Yuxian Bai|Zhengzhou, Henan, China, 450008Principal Investigator: Jufeng Wang|Wuhan, Hubei, China, 430022Principal Investigator: Tao Zhang Hubei Cancer HospitalWuhan, Hubei, China, 430079Principal Investigator: Sheng Hu|Xuzhou, Jiangsu, China, 221009Principal Investigator: Yong Liu|Nanchang, Jiangxi, China, 330006Principal Investigator: Jianbing Wu|Changchun, Jilin, China, 130012Principal Investigator: Ying Cheng The First Hospital Of Jilin UniversityChangchun, Jilin, China, 130021Principal Investigator: Wei Li|Weifang, Shandong, China, 261000Principal Investigator: Guohua Yu|Shanghai, Shanghai, China, 200032Principal Investigator: Zhiqiang Meng Zhongshan Hospital Fudan UniversityShanghai, Shanghai, China, 200032Principal Investigator: Zhenggang Ren|Tianjin, Tianjin, China, 300060Principal Investigator: Huikai Li|Hangzhou, Zhejiang, China, 310003Principal Investigator: Weijia Fang The First Affiliated Hospital, Zhejiang UniversityHangzhou, Zhejiang, China, 310003Principal Investigator: Sheng Yan The Second Affiliated Hospital Of Zhejiang University School Of MedicineHangzhou, Zhejiang, China, 310009Principal Investigator: Xueli Bai Sir Run Run Shaw Hospital, Zhejiang University, School Of MedicineHangzhou, Zhejiang, China, 310016Principal Investigator: Hongming Pan Zhejiang Cancer HospitalHangzhou, Zhejiang, China, 310022Principal Investigator: Guoliang Shao The First Affiliated Hospital Of Wenzhou Medical UniversityWenzhou, Zhejiang, China, 325000Principal Investigator: Congying Xie|Nice Cedex 3, Alpes Maritimes, France, 06202|Pessac Cedex, Gironde, France, 33604Principal Investigator: Jean-Frederic Blanc|Montpellier, Herault, France, 34295|Rennes Cedex, Ille Et Vilaine, France, 35042|Clichy, Paris, France, 92210|Lyon, Rhone, France, 69004 Centre Hospitalier De La Croix RousseLyon, Rhone, France, 69317Principal Investigator: Phillipe Merle|Villejuif Cedex, Val De Marne, France, 94805|Poitiers Cedex, Vienne, France, 8600|Frankfurt Am Main, Hessen, Germany, 60488|Essen, Nordrhein Westfalen, Germany, 45136|Mainz, Rheinland Pflaz, Germany, 55131|Hamburg, Germany, 20246|Bergamo, Italy, 24127|Rozzano, Milano, Italy, 20089|Warszawa, Poland, 02-034Principal Investigator: Krzysztof Simon Centrum Onkologii-Instytut Im. M. Sklodowskiej CurieWroclaw, Poland, 51-162Principal Investigator: Lucjan Wyrwicz|L'Hospitalet De Llobregat, Barcelona, Spain, 08908|Barcelona, Spain, 08035Principal Investigator: Helena Verdaguer Mata Hospital Universitario Reina SofiaCÃ³rdoba, Spain, 14004|Manchester, England, United Kingdom, M20 4Bx|London, Greater London, United Kingdom, Nw3 2Qg|Glasgow, Strathclyde, United Kingdom, G12 Oyn|Birmingham, West Midlands, United Kingdom, B15 2Th|Newcastle Upon Tyne, United Kingdom, Ne7 7DnPrincipal Investigator: Jane Margetts|Saint Louis, Missouri, United States, 63110|Newark, New Jersey, United States, 07013|New York, New York, United States, 10065|Kettering, Ohio, United States, 45409Principal Investigator: Charles Bane","Missouri|New Jersey|New York|Ohio","China|France|Germany|Italy|Poland|Spain|United Kingdom|United States","Anhui Anhui Medical University - The Second Hospital|Chinese Pla General Hospital Medical School Of Chinese Pla|Fujian Fujian Medical University Union Hospital|Guangdong Sun Yat-Sen Memorial Hospital,Sun Yat-Sen University|Heilongjiang Harbin Medical University Cancer Hospital|Henan Henan Cancer Hospital|Hubei Union Hospital Tongji Medical College Huazhong University Of Science And Technology|Jiangsu Xuzhou Central Hospital|Jiangxi The Second Affiliated Hospital Of Nanchang University|Jilin Jilin Cancer Hospital|Shandong Weifang People's Hospital|Shanghai Shanghai Cancer Hospital, Fudan University|Tianjin Tianjin Medical University Cancer Institute & Hospital|Zhejiang The First Affiliated Hospital, Zhejiang University|Alpes Maritimes Chu Nice - HÃ´pital De L'Archet 2|Gironde Groupe Hospitalier Sud - HÃ´pital Haut LÃ©vÃªque|Herault Hopital Saint Eloi|Ille Et Vilaine Crlcc Eugene Marquis|Paris Hopital Beaujon|Rhone Centre Hospitalier De La Croix Rousse|Val De Marne Institut Gustave Roussy|Vienne Chu Poitiers - HÃ´pital La MilÃ©trie|Hessen Krankenhaus Nordwest Gmbh|Nordrhein Westfalen Kliniken Essen-Mitte|Rheinland Pflaz UniversitÃ¤tsmedizin Der Johannes Gutenberg-UniversitÃ¤t Mainz|Universitaetsklinikum Hamburg-Eppendorf|Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii (Presidio Papa Giovanni Xxiii)|Milano Istituto Clinico Humanitas|Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska|Barcelona Ico L'Hospitalet - Hospital Duran I Reynals|Hospital Universitari Vall D'Hebron|, England The Christie Nhs Foundation Trust|, Greater London Royal Free Hospital|, Strathclyde Beatson West Of Scotland Cancer Centre|, West Midlands Queen Elizabeth Hospital|Freeman Hospital|Washington University|Rutgers New Jersey Medical School|Memorial Sloan Kettering Cancer Center|Precision Cancer Research / Dayton Physicians Network",{"$nulls":4},"2018-12-14","2020-05-25T16:40:09.380","2020-05-26T17:10:42.972","NCT03419897"]
["5ecbf4e9e2561b1b11905f05","NCT03419897","2018-12-20","BeiGene","BGNE","Recruiting","Study of BGB-A317 in Patients With Previously Treated Unresectable HCC","Tislelizumab","PD-1 Inhibitor","Yes","['Tislelizumab']","No",null,"Phase 2",1,228,"Anticipated","2018-04-09","2021-03-01","RR","Response Rate",{"$nulls":3},"This is a Phase 2, Open-label, Multicenter Study to Investigate the Efficacy, Safety, and Pharmacokinetics of the Anti-PD-1 Monoclonal Antibody BGB-A317 in Patients with Previously Treated Hepatocellular Unresectable Carcinoma.",null,"RATIONALE-208: A Phase 2, Open-label, Multicenter Study to Investigate the Efficacy, Safety, and Pharmacokinetics of the Anti-PD-1 Monoclonal Antibody BGB-A317 in Patients With Previously Treated Hepatocellular Unresectable Carcinoma","BGB-A317-208","Hepatocellular Carcinoma (HCC)","Noma|Carcinoma|Hepatocellular Carcinoma","Mouth Diseases|Oncology Solid Tumor","Ear, Nose and Throat|Oncology","Experimental","BGB-A317","BGB-A317: 200 mg once every 3 weeks (Q3W), intravenous dosing (IV)","Drug","BGB-A317","Anti-PD-1 ANTIBODY",null,"BGB-A317","\n\n 1. Histologically confirmed HCC\n 2. Patients with Barcelona Clinic Liver Cancer (BCLC) Stage C, or BCLC stage B not amenable to locoregional therapy or relapsed after locoregional therapy, and not amenable to a curative treatment approach\n 3. Has received at least 1 line of systemic therapy for unresectable HCC\n 4. Has at least 1 measurable lesion as defined per RECIST v1.1\n 5. Child-Pugh score A\n 6. Easter Cooperative Oncology Group (ECOG) Performance Status â‰¤ 1\n 7. Adequate organ function\n\n","\n\n 1. Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC histology\n 2. Prior therapies targeting PD-1 or PD-L1\n 3. Has Known brain or leptomeningeal metastasis\n 4. Tumor thrombus involving main trunk of portal vein or inferior vena cava\n 5. Loco-regional therapy to the liver within 4 weeks before enrollment\n 6. Medical history of interstitial lung disease, non-infectious pneumonitis or uncontrolled systemic diseases, including diabetes, hypertension, pulmonary fibrosis, acute lung diseases, etc\n 7. Has received: 1. Within 28 days or 5 half-lives (whichever is shorter) of the first study drug administration: any chemotherapy, immunotherapy (eg, interleukin, interferon, thymoxin) or any investigational therapies\n     2. Within 14 days of the first study drug administration: sorafenib, regorafenib, or any Chinese herbal medicine or Chinese patent medicines used to control cancer\n    \n    \n 8. Active autoimmune diseases or history of autoimmune diseases that may relapse\n 9. Patient with any condition requiring systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication within 14 days before study drug administration",{"$nulls":4},"Actual","2018-02-05","Actual","Anticipated","2021-09-01","Anticipated","2018-12-01","2018-01-29","2018-02-01","2018-12-18","Yes","Advanced liver cancer\nRATIONALE-208","Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No","Undecided",{"$nulls":3},"Yes","No",{"$nulls":19},"Objective Response Rate (ORR) assessed by Independent Review Committee (IRC)","From date of enrollment up to 4 years, approximately",null,"Duration of Response (DOR)|Progression-free survival (PFS)|Disease Control Rate (DCR)|Clinical benefit rate (CBR)|Overall Survival|Percentage of patients with adverse events|Health-Related Quality of Life (HRQoL)|Percentage of Participants With Clinically Significant Changes in Vital Signs Findings|Percentage of Participants With Clinically Significant Changes in Physical Examination Findings|Percentage of Participants With Clinically Significant Changes in Clinical Laboratory Results Findings|Percentage of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Findings","From first determination of an objective response up to 4 years, approximately|From date of enrollment up to 4 years, approximately|From first dose of study treatment up to 4 years, approximately|From first dose of study treatment up to 4 years, approximately.|From date of enrollment up to 4 years, approximately.|At screening or baseline up to 4 years, approximately",null,"clinicaltrials@beigene.com","Jeannie Hou, Senior Director","1 (877) 828-5568","Hefei, Anhui, China, 230071Principal Investigator: Yueyin Pan Anhui Provincial HospitalHefei, Anhui, China, 230071Principal Investigator: Yueyin Pan The Second Hospital Of Anhui Medical HospitalHefei, Anhui, China, 230601Principal Investigator: Zhendong Chen|Beijing, China, 100853Principal Investigator: Li Bai|Fuzhou, Fujian, China, 350001Principal Investigator: Xiaoyan Lin|Guangzhou, Guangdong, China, 510288Principal Investigator: Yajin Chen Nanfang Hospital Of Southern Medical UniversityGuangzhou, Guangdong, China, 510515Principal Investigator: Jinlin Hou Peking University Shenzhen HospitalShenzhen, Guangdong, China, 518036Principal Investigator: Junhui Chen|Harbin, Heilongjiang, China, 150081Principal Investigator: Yuxian Bai|Zhengzhou, Henan, China, 450008Principal Investigator: Jufeng Wang|Wuhan, Hubei, China, 430022Principal Investigator: Tao Zhang Hubei Cancer HospitalWuhan, Hubei, China, 430079Principal Investigator: Sheng Hu|Xuzhou, Jiangsu, China, 221009Principal Investigator: Yong Liu|Nanchang, Jiangxi, China, 330006Principal Investigator: Jianbing Wu|Changchun, Jilin, China, 130012Principal Investigator: Ying Cheng The First Hospital Of Jilin UniversityChangchun, Jilin, China, 130021Principal Investigator: Wei Li|Weifang, Shandong, China, 261000Principal Investigator: Guohua Yu|Shanghai, Shanghai, China, 200032Principal Investigator: Zhiqiang Meng Zhongshan Hospital Fudan UniversityShanghai, Shanghai, China, 200032Principal Investigator: Zhenggang Ren|Tianjin, Tianjin, China, 300060Principal Investigator: Huikai Li|Hangzhou, Zhejiang, China, 310003Principal Investigator: Weijia Fang The First Affiliated Hospital, Zhejiang UniversityHangzhou, Zhejiang, China, 310003Principal Investigator: Sheng Yan The Second Affiliated Hospital Of Zhejiang University School Of MedicineHangzhou, Zhejiang, China, 310009Principal Investigator: Xueli Bai Sir Run Run Shaw Hospital, Zhejiang University, School Of MedicineHangzhou, Zhejiang, China, 310016Principal Investigator: Hongming Pan Zhejiang Cancer HospitalHangzhou, Zhejiang, China, 310022Principal Investigator: Guoliang Shao The First Affiliated Hospital Of Wenzhou Medical UniversityWenzhou, Zhejiang, China, 325000Principal Investigator: Congying Xie|Nice Cedex 3, Alpes Maritimes, France, 06202|Pessac Cedex, Gironde, France, 33604Principal Investigator: Jean-Frederic Blanc|Montpellier, Herault, France, 34295|Rennes Cedex, Ille Et Vilaine, France, 35042|Clichy, Paris, France, 92210|Lyon, Rhone, France, 69004 Centre Hospitalier De La Croix RousseLyon, Rhone, France, 69317Principal Investigator: Phillipe Merle|Villejuif Cedex, Val De Marne, France, 94805|Poitiers Cedex, Vienne, France, 8600|Frankfurt Am Main, Hessen, Germany, 60488|Essen, Nordrhein Westfalen, Germany, 45136|Mainz, Rheinland Pflaz, Germany, 55131|Hamburg, Germany, 20246|Bergamo, Italy, 24127|Rozzano, Milano, Italy, 20089|Warszawa, Poland, 02-034Principal Investigator: Krzysztof Simon Centrum Onkologii-Instytut Im. M. Sklodowskiej CurieWroclaw, Poland, 51-162Principal Investigator: Lucjan Wyrwicz|L'Hospitalet De Llobregat, Barcelona, Spain, 08908|Barcelona, Spain, 08035Principal Investigator: Helena Verdaguer Mata Hospital Universitario Reina SofiaCÃ³rdoba, Spain, 14004|Manchester, England, United Kingdom, M20 4Bx|London, Greater London, United Kingdom, Nw3 2Qg|Glasgow, Strathclyde, United Kingdom, G12 Oyn|Birmingham, West Midlands, United Kingdom, B15 2Th|Newcastle Upon Tyne, United Kingdom, Ne7 7DnPrincipal Investigator: Jane Margetts|Saint Louis, Missouri, United States, 63110|Newark, New Jersey, United States, 07013|New York, New York, United States, 10065|Kettering, Ohio, United States, 45409Principal Investigator: Charles Bane","Missouri|New Jersey|New York|Ohio","China|France|Germany|Italy|Poland|Spain|United Kingdom|United States","Anhui Anhui Medical University - The Second Hospital|Chinese Pla General Hospital Medical School Of Chinese Pla|Fujian Fujian Medical University Union Hospital|Guangdong Sun Yat-Sen Memorial Hospital,Sun Yat-Sen University|Heilongjiang Harbin Medical University Cancer Hospital|Henan Henan Cancer Hospital|Hubei Union Hospital Tongji Medical College Huazhong University Of Science And Technology|Jiangsu Xuzhou Central Hospital|Jiangxi The Second Affiliated Hospital Of Nanchang University|Jilin Jilin Cancer Hospital|Shandong Weifang People's Hospital|Shanghai Shanghai Cancer Hospital, Fudan University|Tianjin Tianjin Medical University Cancer Institute & Hospital|Zhejiang The First Affiliated Hospital, Zhejiang University|Alpes Maritimes Chu Nice - HÃ´pital De L'Archet 2|Gironde Groupe Hospitalier Sud - HÃ´pital Haut LÃ©vÃªque|Herault Hopital Saint Eloi|Ille Et Vilaine Crlcc Eugene Marquis|Paris Hopital Beaujon|Rhone Centre Hospitalier De La Croix Rousse|Val De Marne Institut Gustave Roussy|Vienne Chu Poitiers - HÃ´pital La MilÃ©trie|Hessen Krankenhaus Nordwest Gmbh|Nordrhein Westfalen Kliniken Essen-Mitte|Rheinland Pflaz UniversitÃ¤tsmedizin Der Johannes Gutenberg-UniversitÃ¤t Mainz|Universitaetsklinikum Hamburg-Eppendorf|Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii (Presidio Papa Giovanni Xxiii)|Milano Istituto Clinico Humanitas|Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska|Barcelona Ico L'Hospitalet - Hospital Duran I Reynals|Hospital Universitari Vall D'Hebron|, England The Christie Nhs Foundation Trust|, Greater London Royal Free Hospital|, Strathclyde Beatson West Of Scotland Cancer Centre|, West Midlands Queen Elizabeth Hospital|Freeman Hospital|Washington University|Rutgers New Jersey Medical School|Memorial Sloan Kettering Cancer Center|Precision Cancer Research / Dayton Physicians Network",{"$nulls":4},"2018-12-18","2020-05-25T16:40:09.382","2020-05-26T17:10:42.972","NCT03419897"]
["5ecbf4e9307e3d1b1f8d9e9d","NCT03419897","2019-02-04","BeiGene","BGNE","Active, not recruiting","Study of BGB-A317 in Patients With Previously Treated Unresectable HCC","Tislelizumab","PD-1 Inhibitor","Yes","['Tislelizumab']","No",null,"Phase 2",1,228,"Anticipated","2018-04-09","2021-03-01","RR","Response Rate",{"$nulls":3},"This is a Phase 2, Open-label, Multicenter Study to Investigate the Efficacy, Safety, and Pharmacokinetics of the Anti-PD-1 Monoclonal Antibody BGB-A317 in Patients with Previously Treated Hepatocellular Unresectable Carcinoma.",null,"RATIONALE-208: A Phase 2, Open-label, Multicenter Study to Investigate the Efficacy, Safety, and Pharmacokinetics of the Anti-PD-1 Monoclonal Antibody BGB-A317 in Patients With Previously Treated Hepatocellular Unresectable Carcinoma","BGB-A317-208","Hepatocellular Carcinoma (HCC)","Noma|Carcinoma|Hepatocellular Carcinoma","Mouth Diseases|Oncology Solid Tumor","Ear, Nose and Throat|Oncology","Experimental","BGB-A317","BGB-A317: 200 mg once every 3 weeks (Q3W), intravenous dosing (IV)","Drug","BGB-A317","Anti-PD-1 ANTIBODY",null,"BGB-A317","\n\n 1. Histologically confirmed HCC\n 2. Patients with Barcelona Clinic Liver Cancer (BCLC) Stage C, or BCLC stage B not amenable to locoregional therapy or relapsed after locoregional therapy, and not amenable to a curative treatment approach\n 3. Has received at least 1 line of systemic therapy for unresectable HCC\n 4. Has at least 1 measurable lesion as defined per RECIST v1.1\n 5. Child-Pugh score A\n 6. Easter Cooperative Oncology Group (ECOG) Performance Status â‰¤ 1\n 7. Adequate organ function\n\n","\n\n 1. Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC histology\n 2. Prior therapies targeting PD-1 or PD-L1\n 3. Has Known brain or leptomeningeal metastasis\n 4. Tumor thrombus involving main trunk of portal vein or inferior vena cava\n 5. Loco-regional therapy to the liver within 4 weeks before enrollment\n 6. Medical history of interstitial lung disease, non-infectious pneumonitis or uncontrolled systemic diseases, including diabetes, hypertension, pulmonary fibrosis, acute lung diseases, etc\n 7. Has received: 1. Within 28 days or 5 half-lives (whichever is shorter) of the first study drug administration: any chemotherapy, immunotherapy (eg, interleukin, interferon, thymoxin) or any investigational therapies\n     2. Within 14 days of the first study drug administration: sorafenib, regorafenib, or any Chinese herbal medicine or Chinese patent medicines used to control cancer\n    \n    \n 8. Active autoimmune diseases or history of autoimmune diseases that may relapse\n 9. Patient with any condition requiring systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication within 14 days before study drug administration",{"$nulls":4},"Actual","2018-02-05","Actual","Anticipated","2021-09-01","Anticipated","2019-01-01","2018-01-29","2018-02-01","2019-01-31","Yes","Advanced liver cancer\nRATIONALE-208","Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No","Undecided",{"$nulls":3},"Yes","No",{"$nulls":19},"Objective Response Rate (ORR) assessed by Independent Review Committee (IRC)","From date of enrollment up to 4 years, approximately",null,"Duration of Response (DOR)|Progression-free survival (PFS)|Disease Control Rate (DCR)|Clinical benefit rate (CBR)|Overall Survival|Percentage of patients with adverse events|Health-Related Quality of Life (HRQoL)|Percentage of Participants With Clinically Significant Changes in Vital Signs Findings|Percentage of Participants With Clinically Significant Changes in Physical Examination Findings|Percentage of Participants With Clinically Significant Changes in Clinical Laboratory Results Findings|Percentage of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Findings","From first determination of an objective response up to 4 years, approximately|From date of enrollment up to 4 years, approximately|From first dose of study treatment up to 4 years, approximately|From first dose of study treatment up to 4 years, approximately.|From date of enrollment up to 4 years, approximately.|At screening or baseline up to 4 years, approximately",{"$nulls":4},"Hefei, Anhui, China, 230071 Anhui Provincial HospitalHefei, Anhui, China, 230071 The Second Hospital Of Anhui Medical HospitalHefei, Anhui, China, 230601|Beijing, China, 100853|Fuzhou, Fujian, China, 350001|Guangzhou, Guangdong, China, 510288 Nanfang Hospital Of Southern Medical UniversityGuangzhou, Guangdong, China, 510515 Peking University Shenzhen HospitalShenzhen, Guangdong, China, 518036|Harbin, Heilongjiang, China, 150081|Zhengzhou, Henan, China, 450008|Wuhan, Hubei, China, 430022 Hubei Cancer HospitalWuhan, Hubei, China, 430079|Xuzhou, Jiangsu, China, 221009|Nanchang, Jiangxi, China, 330006|Changchun, Jilin, China, 130012 The First Hospital Of Jilin UniversityChangchun, Jilin, China, 130021|Weifang, Shandong, China, 261000|Shanghai, Shanghai, China, 200032 Zhongshan Hospital Fudan UniversityShanghai, Shanghai, China, 200032|Tianjin, Tianjin, China, 300060|Hangzhou, Zhejiang, China, 310003 The Second Affiliated Hospital Of Zhejiang University School Of MedicineHangzhou, Zhejiang, China, 310009 Sir Run Run Shaw Hospital, Zhejiang University, School Of MedicineHangzhou, Zhejiang, China, 310016 Zhejiang Cancer HospitalHangzhou, Zhejiang, China, 310022 The First Affiliated Hospital Of Wenzhou Medical UniversityWenzhou, Zhejiang, China, 325000|Nice Cedex 3, Alpes Maritimes, France, 06202|Pessac Cedex, Gironde, France, 33604|Montpellier, Herault, France, 34295|Rennes Cedex, Ille Et Vilaine, France, 35042|Clichy, Paris, France, 92210|Lyon, Rhone, France, 69004 Centre Hospitalier De La Croix RousseLyon, Rhone, France, 69317|Villejuif Cedex, Val De Marne, France, 94805|Poitiers Cedex, Vienne, France, 8600|Essen, Nordrhein Westfalen, Germany, 45136|Mainz, Rheinland Pflaz, Germany, 55131|Hamburg, Germany, 20246|Bergamo, Italy, 24127 Azienda Ospedaliero Universitaria PisanaPisa, Italy, 56126 UniversitÃ  Campus Bio-Medico Di RomaRoma, Italy, 00128|Rozzano, Milano, Italy, 20089|Warszawa, Poland, 02-034 Centrum Onkologii-Instytut Im. M. Sklodowskiej CurieWroclaw, Poland, 51-162|L'Hospitalet De Llobregat, Barcelona, Spain, 08908|Barcelona, Spain, 08035 Hospital Universitario Reina SofiaCÃ³rdoba, Spain, 14004 Hospital Universitario RamÃ³n Y CajalMadrid, Spain, 28034 Hospital Universitario La PazMadrid, Spain, 28046 Hospital Universitario Hm Madrid SanchinarroMadrid, Spain, 28050 Taiwan Chiayi Chang Gung Memorial Hospital Of The Chang Gung Medical FoundationChiayi City, Taiwan Chang Gung Memorial Hospital, KaohsiungKaohsiung, Taiwan, 833 National Cheng Kung University HospitalTainan, Taiwan, 70403 National Taiwan University HospitalTaipei, Taiwan, 100 Taipei Veterans General HospitalTaipei, Taiwan, 11217 Chang Gung Memorial Hospital, LinkouTaoyuan, Taiwan, 333|Manchester, England, United Kingdom, M20 4Bx|London, Greater London, United Kingdom, Nw3 2Qg King'S College HospitalLondon, Greater London, United Kingdom, Se5 9Rs The Sarah Cannon Research Institute UkLondon, Greater London, United Kingdom, W1G 6Ad|Glasgow, Strathclyde, United Kingdom, G12 Oyn|Birmingham, West Midlands, United Kingdom, B15 2Th|Newcastle Upon Tyne, United Kingdom, Ne7 7Dn",null,"China|France|Germany|Italy|Poland|Spain|United Kingdom","Anhui Anhui Medical University - The Second Hospital|Chinese Pla General Hospital Medical School Of Chinese Pla|Fujian Fujian Medical University Union Hospital|Guangdong Sun Yat-Sen Memorial Hospital,Sun Yat-Sen University|Heilongjiang Harbin Medical University Cancer Hospital|Henan Henan Cancer Hospital|Hubei Union Hospital Tongji Medical College Huazhong University Of Science And Technology|Jiangsu Xuzhou Central Hospital|Jiangxi The Second Affiliated Hospital Of Nanchang University|Jilin Jilin Cancer Hospital|Shandong Weifang People's Hospital|Shanghai Shanghai Cancer Hospital, Fudan University|Tianjin Tianjin Medical University Cancer Institute & Hospital|Zhejiang The First Affiliated Hospital, Zhejiang University|Alpes Maritimes Chu Nice - HÃ´pital De L'Archet 2|Gironde Groupe Hospitalier Sud - HÃ´pital Haut LÃ©vÃªque|Herault Hopital Saint Eloi|Ille Et Vilaine Crlcc Eugene Marquis|Paris Hopital Beaujon|Rhone Centre Hospitalier De La Croix Rousse|Val De Marne Institut Gustave Roussy|Vienne Chu Poitiers - HÃ´pital La MilÃ©trie|Nordrhein Westfalen Kliniken Essen-Mitte|Rheinland Pflaz UniversitÃ¤tsmedizin Der Johannes Gutenberg-UniversitÃ¤t Mainz|Universitaetsklinikum Hamburg-Eppendorf|Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii (Presidio Papa Giovanni Xxiii)|Milano Istituto Clinico Humanitas|Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska|Barcelona Ico L'Hospitalet - Hospital Duran I Reynals|Hospital Universitari Vall D'Hebron|, England The Christie Nhs Foundation Trust|, Greater London Royal Free Hospital|, Strathclyde Beatson West Of Scotland Cancer Centre|, West Midlands Queen Elizabeth Hospital|Freeman Hospital",{"$nulls":4},"2019-01-31","2020-05-25T16:40:09.984","2020-05-26T17:10:42.972","NCT03419897"]
["5ecbf4e9fe30261b1a04840b","NCT03419897","2019-03-06","BeiGene","BGNE","Active, not recruiting","Study of BGB-A317 in Patients With Previously Treated Unresectable HCC","Tislelizumab","PD-1 Inhibitor","Yes","['Tislelizumab']","No",null,"Phase 2",1,228,"Anticipated","2018-04-09","2021-03-01","RR","Response Rate",{"$nulls":3},"This is a Phase 2, Open-label, Multicenter Study to Investigate the Efficacy, Safety, and Pharmacokinetics of the Anti-PD-1 Monoclonal Antibody BGB-A317 in Patients with Previously Treated Hepatocellular Unresectable Carcinoma.",null,"RATIONALE-208: A Phase 2, Open-label, Multicenter Study to Investigate the Efficacy, Safety, and Pharmacokinetics of the Anti-PD-1 Monoclonal Antibody BGB-A317 in Patients With Previously Treated Hepatocellular Unresectable Carcinoma","BGB-A317-208","Hepatocellular Carcinoma (HCC)","Noma|Carcinoma|Hepatocellular Carcinoma","Mouth Diseases|Oncology Solid Tumor","Ear, Nose and Throat|Oncology","Experimental","BGB-A317","BGB-A317: 200 mg once every 3 weeks (Q3W), intravenous dosing (IV)","Drug","BGB-A317","Anti-PD-1 ANTIBODY",null,"BGB-A317","\n\n 1. Histologically confirmed HCC\n 2. Patients with Barcelona Clinic Liver Cancer (BCLC) Stage C, or BCLC stage B not amenable to locoregional therapy or relapsed after locoregional therapy, and not amenable to a curative treatment approach\n 3. Has received at least 1 line of systemic therapy for unresectable HCC\n 4. Has at least 1 measurable lesion as defined per RECIST v1.1\n 5. Child-Pugh score A\n 6. Easter Cooperative Oncology Group (ECOG) Performance Status â‰¤ 1\n 7. Adequate organ function\n\n","\n\n 1. Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC histology\n 2. Prior therapies targeting PD-1 or PD-L1\n 3. Has Known brain or leptomeningeal metastasis\n 4. Tumor thrombus involving main trunk of portal vein or inferior vena cava\n 5. Loco-regional therapy to the liver within 4 weeks before enrollment\n 6. Medical history of interstitial lung disease, non-infectious pneumonitis or uncontrolled systemic diseases, including diabetes, hypertension, pulmonary fibrosis, acute lung diseases, etc\n 7. Has received: 1. Within 28 days or 5 half-lives (whichever is shorter) of the first study drug administration: any chemotherapy, immunotherapy (eg, interleukin, interferon, thymoxin) or any investigational therapies\n     2. Within 14 days of the first study drug administration: sorafenib, regorafenib, or any Chinese herbal medicine or Chinese patent medicines used to control cancer\n    \n    \n 8. Active autoimmune diseases or history of autoimmune diseases that may relapse\n 9. Patient with any condition requiring systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication within 14 days before study drug administration",{"$nulls":4},"Actual","2018-02-05","Actual","Anticipated","2021-09-01","Anticipated","2019-03-01","2018-01-29","2018-02-01","2019-03-04","Yes","Advanced liver cancer\nRATIONALE-208","Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No","Undecided",{"$nulls":3},"Yes","No",{"$nulls":19},"Objective Response Rate (ORR) assessed by Independent Review Committee (IRC)","From date of enrollment up to 4 years, approximately",null,"Duration of Response (DOR)|Progression-free survival (PFS)|Disease Control Rate (DCR)|Clinical benefit rate (CBR)|Overall Survival|Percentage of patients with adverse events|Health-Related Quality of Life (HRQoL)|Percentage of Participants With Clinically Significant Changes in Vital Signs Findings|Percentage of Participants With Clinically Significant Changes in Physical Examination Findings|Percentage of Participants With Clinically Significant Changes in Clinical Laboratory Results Findings|Percentage of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Findings","From first determination of an objective response up to 4 years, approximately|From date of enrollment up to 4 years, approximately|From first dose of study treatment up to 4 years, approximately|From first dose of study treatment up to 4 years, approximately.|From date of enrollment up to 4 years, approximately.|At screening or baseline up to 4 years, approximately",{"$nulls":4},"Hefei, Anhui, China, 230071 Anhui Provincial HospitalHefei, Anhui, China, 230071 The Second Hospital Of Anhui Medical HospitalHefei, Anhui, China, 230601|Beijing, China, 100853|Fuzhou, Fujian, China, 350001|Guangzhou, Guangdong, China, 510288 Nanfang Hospital Of Southern Medical UniversityGuangzhou, Guangdong, China, 510515 Peking University Shenzhen HospitalShenzhen, Guangdong, China, 518036|Harbin, Heilongjiang, China, 150081|Zhengzhou, Henan, China, 450008|Wuhan, Hubei, China, 430022 Hubei Cancer HospitalWuhan, Hubei, China, 430079|Xuzhou, Jiangsu, China, 221009|Nanchang, Jiangxi, China, 330006|Changchun, Jilin, China, 130012 The First Hospital Of Jilin UniversityChangchun, Jilin, China, 130021|Weifang, Shandong, China, 261000|Shanghai, Shanghai, China, 200032 Zhongshan Hospital Fudan UniversityShanghai, Shanghai, China, 200032|Tianjin, Tianjin, China, 300060|Hangzhou, Zhejiang, China, 310003 The Second Affiliated Hospital Of Zhejiang University School Of MedicineHangzhou, Zhejiang, China, 310009 Sir Run Run Shaw Hospital, Zhejiang University, School Of MedicineHangzhou, Zhejiang, China, 310016 Zhejiang Cancer HospitalHangzhou, Zhejiang, China, 310022 The First Affiliated Hospital Of Wenzhou Medical UniversityWenzhou, Zhejiang, China, 325000|Nice Cedex 3, Alpes Maritimes, France, 06202|Pessac Cedex, Gironde, France, 33604|Montpellier, Herault, France, 34295|Rennes Cedex, Ille Et Vilaine, France, 35042|Clichy, Paris, France, 92210|Lyon, Rhone, France, 69004 Centre Hospitalier De La Croix RousseLyon, Rhone, France, 69317|Villejuif Cedex, Val De Marne, France, 94805|Poitiers Cedex, Vienne, France, 8600|Essen, Nordrhein Westfalen, Germany, 45136|Mainz, Rheinland Pflaz, Germany, 55131|Hamburg, Germany, 20246|Bergamo, Italy, 24127 Azienda Ospedaliero Universitaria PisanaPisa, Italy, 56126 UniversitÃ  Campus Bio-Medico Di RomaRoma, Italy, 00128|Rozzano, Milano, Italy, 20089|Warszawa, Poland, 02-034 Centrum Onkologii-Instytut Im. M. Sklodowskiej CurieWroclaw, Poland, 51-162|L'Hospitalet De Llobregat, Barcelona, Spain, 08908|Barcelona, Spain, 08035 Hospital Universitario Reina SofiaCÃ³rdoba, Spain, 14004 Hospital Universitario RamÃ³n Y CajalMadrid, Spain, 28034 Hospital Universitario La PazMadrid, Spain, 28046 Hospital Universitario Hm Madrid SanchinarroMadrid, Spain, 28050 Taiwan Chiayi Chang Gung Memorial Hospital Of The Chang Gung Medical FoundationChiayi City, Taiwan Chang Gung Memorial Hospital, KaohsiungKaohsiung, Taiwan, 833 National Cheng Kung University HospitalTainan, Taiwan, 70403 National Taiwan University HospitalTaipei, Taiwan, 100 Taipei Veterans General HospitalTaipei, Taiwan, 11217 Chang Gung Memorial Hospital, LinkouTaoyuan, Taiwan, 333|Manchester, England, United Kingdom, M20 4Bx|London, Greater London, United Kingdom, Nw3 2Qg King'S College HospitalLondon, Greater London, United Kingdom, Se5 9Rs The Sarah Cannon Research Institute UkLondon, Greater London, United Kingdom, W1G 6Ad|Glasgow, Strathclyde, United Kingdom, G12 Oyn|Birmingham, West Midlands, United Kingdom, B15 2Th|Newcastle Upon Tyne, United Kingdom, Ne7 7Dn",null,"China|France|Germany|Italy|Poland|Spain|United Kingdom","Anhui Anhui Medical University - The Second Hospital|Chinese Pla General Hospital Medical School Of Chinese Pla|Fujian Fujian Medical University Union Hospital|Guangdong Sun Yat-Sen Memorial Hospital,Sun Yat-Sen University|Heilongjiang Harbin Medical University Cancer Hospital|Henan Henan Cancer Hospital|Hubei Union Hospital Tongji Medical College Huazhong University Of Science And Technology|Jiangsu Xuzhou Central Hospital|Jiangxi The Second Affiliated Hospital Of Nanchang University|Jilin Jilin Cancer Hospital|Shandong Weifang People's Hospital|Shanghai Shanghai Cancer Hospital, Fudan University|Tianjin Tianjin Medical University Cancer Institute & Hospital|Zhejiang The First Affiliated Hospital, Zhejiang University|Alpes Maritimes Chu Nice - HÃ´pital De L'Archet 2|Gironde Groupe Hospitalier Sud - HÃ´pital Haut LÃ©vÃªque|Herault Hopital Saint Eloi|Ille Et Vilaine Crlcc Eugene Marquis|Paris Hopital Beaujon|Rhone Centre Hospitalier De La Croix Rousse|Val De Marne Institut Gustave Roussy|Vienne Chu Poitiers - HÃ´pital La MilÃ©trie|Nordrhein Westfalen Kliniken Essen-Mitte|Rheinland Pflaz UniversitÃ¤tsmedizin Der Johannes Gutenberg-UniversitÃ¤t Mainz|Universitaetsklinikum Hamburg-Eppendorf|Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii (Presidio Papa Giovanni Xxiii)|Milano Istituto Clinico Humanitas|Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska|Barcelona Ico L'Hospitalet - Hospital Duran I Reynals|Hospital Universitari Vall D'Hebron|, England The Christie Nhs Foundation Trust|, Greater London Royal Free Hospital|, Strathclyde Beatson West Of Scotland Cancer Centre|, West Midlands Queen Elizabeth Hospital|Freeman Hospital",{"$nulls":4},"2019-03-04","2020-05-25T16:40:09.622","2020-05-26T17:10:42.972","NCT03419897"]
["5ecbf4e9307e3d1b1f8d9e9c","NCT03419897","2019-07-19","BeiGene","BGNE","Active, not recruiting","Study of BGB-A317 in Patients With Previously Treated Unresectable HCC","Tislelizumab","PD-1 Inhibitor","Yes","['Tislelizumab']","No",null,"Phase 2",1,228,"Anticipated","2018-04-09","2021-03-01","RR","Response Rate",{"$nulls":3},"This is a Phase 2, Open-label, Multicenter Study to Investigate the Efficacy, Safety, and Pharmacokinetics of the Anti-PD-1 Monoclonal Antibody BGB-A317 in Patients with Previously Treated Hepatocellular Unresectable Carcinoma.",null,"RATIONALE-208: A Phase 2, Open-label, Multicenter Study to Investigate the Efficacy, Safety, and Pharmacokinetics of the Anti-PD-1 Monoclonal Antibody BGB-A317 in Patients With Previously Treated Hepatocellular Unresectable Carcinoma","BGB-A317-208","Hepatocellular Carcinoma (HCC)","Noma|Carcinoma|Hepatocellular Carcinoma","Mouth Diseases|Oncology Solid Tumor","Ear, Nose and Throat|Oncology","Experimental","BGB-A317","BGB-A317: 200 mg once every 3 weeks (Q3W), intravenous dosing (IV)","Drug","BGB-A317","Anti-PD-1 ANTIBODY",null,"BGB-A317","\n\n 1. Histologically confirmed HCC\n 2. Patients with Barcelona Clinic Liver Cancer (BCLC) Stage C, or BCLC stage B not amenable to locoregional therapy or relapsed after locoregional therapy, and not amenable to a curative treatment approach\n 3. Has received at least 1 line of systemic therapy for unresectable HCC\n 4. Has at least 1 measurable lesion as defined per RECIST v1.1\n 5. Child-Pugh score A\n 6. Easter Cooperative Oncology Group (ECOG) Performance Status â‰¤ 1\n 7. Adequate organ function\n\n","\n\n 1. Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC histology\n 2. Prior therapies targeting PD-1 or PD-L1\n 3. Has Known brain or leptomeningeal metastasis\n 4. Tumor thrombus involving main trunk of portal vein or inferior vena cava\n 5. Loco-regional therapy to the liver within 4 weeks before enrollment\n 6. Medical history of interstitial lung disease, non-infectious pneumonitis or uncontrolled systemic diseases, including diabetes, hypertension, pulmonary fibrosis, acute lung diseases, etc\n 7. Has received: 1. Within 28 days or 5 half-lives (whichever is shorter) of the first study drug administration: any chemotherapy, immunotherapy (eg, interleukin, interferon, thymoxin) or any investigational therapies\n     2. Within 14 days of the first study drug administration: sorafenib, regorafenib, or any Chinese herbal medicine or Chinese patent medicines used to control cancer\n    \n    \n 8. Active autoimmune diseases or history of autoimmune diseases that may relapse\n 9. Patient with any condition requiring systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication within 14 days before study drug administration",{"$nulls":4},"Actual","2018-02-05","Actual","Anticipated","2021-09-01","Anticipated","2019-03-01","2018-01-29","2018-02-01","2019-07-17","Yes","Advanced liver cancer\nRATIONALE-208","Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No","Undecided",{"$nulls":3},"Yes","No",{"$nulls":17},"2017-003983-10|CTR20171257","EudraCT Number|Registry Identifier: Center for drug evaluation, CFDA","Objective Response Rate (ORR) assessed by Independent Review Committee (IRC)","From date of enrollment up to 4 years, approximately",null,"Duration of Response (DOR)|Progression-free survival (PFS)|Disease Control Rate (DCR)|Clinical benefit rate (CBR)|Overall Survival|Percentage of patients with adverse events|Health-Related Quality of Life (HRQoL)|Percentage of Participants With Clinically Significant Changes in Vital Signs Findings|Percentage of Participants With Clinically Significant Changes in Physical Examination Findings|Percentage of Participants With Clinically Significant Changes in Clinical Laboratory Results Findings|Percentage of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Findings","From first determination of an objective response up to 4 years, approximately|From date of enrollment up to 4 years, approximately|From first dose of study treatment up to 4 years, approximately|From first dose of study treatment up to 4 years, approximately.|From date of enrollment up to 4 years, approximately.|At screening or baseline up to 4 years, approximately",{"$nulls":4},"Hefei, Anhui, China, 230071 Anhui Provincial HospitalHefei, Anhui, China, 230071 The Second Hospital Of Anhui Medical HospitalHefei, Anhui, China, 230601|Beijing, China, 100853|Fuzhou, Fujian, China, 350001|Guangzhou, Guangdong, China, 510288 Nanfang Hospital Of Southern Medical UniversityGuangzhou, Guangdong, China, 510515 Peking University Shenzhen HospitalShenzhen, Guangdong, China, 518036|Harbin, Heilongjiang, China, 150081|Zhengzhou, Henan, China, 450008|Wuhan, Hubei, China, 430022 Hubei Cancer HospitalWuhan, Hubei, China, 430079|Xuzhou, Jiangsu, China, 221009|Nanchang, Jiangxi, China, 330006|Changchun, Jilin, China, 130012 The First Hospital Of Jilin UniversityChangchun, Jilin, China, 130021|Weifang, Shandong, China, 261000|Shanghai, Shanghai, China, 200032 Zhongshan Hospital Fudan UniversityShanghai, Shanghai, China, 200032|Tianjin, Tianjin, China, 300060|Hangzhou, Zhejiang, China, 310003 The Second Affiliated Hospital Of Zhejiang University School Of MedicineHangzhou, Zhejiang, China, 310009 Sir Run Run Shaw Hospital, Zhejiang University, School Of MedicineHangzhou, Zhejiang, China, 310016 Zhejiang Cancer HospitalHangzhou, Zhejiang, China, 310022 The First Affiliated Hospital Of Wenzhou Medical UniversityWenzhou, Zhejiang, China, 325000|Nice Cedex 3, Alpes Maritimes, France, 06202|Pessac Cedex, Gironde, France, 33604|Montpellier, Herault, France, 34295|Rennes Cedex, Ille Et Vilaine, France, 35042|Clichy, Paris, France, 92210|Lyon, Rhone, France, 69004 Centre Hospitalier De La Croix RousseLyon, Rhone, France, 69317|Villejuif Cedex, Val De Marne, France, 94805|Poitiers Cedex, Vienne, France, 8600|Essen, Nordrhein Westfalen, Germany, 45136|Mainz, Rheinland Pflaz, Germany, 55131|Hamburg, Germany, 20246|Bergamo, Italy, 24127 Azienda Ospedaliero Universitaria PisanaPisa, Italy, 56126 UniversitÃ  Campus Bio-Medico Di RomaRoma, Italy, 00128|Rozzano, Milano, Italy, 20089|Warszawa, Poland, 02-034 Centrum Onkologii-Instytut Im. M. Sklodowskiej CurieWroclaw, Poland, 51-162|L'Hospitalet De Llobregat, Barcelona, Spain, 08908|Barcelona, Spain, 08035 Hospital Universitario Reina SofiaCÃ³rdoba, Spain, 14004 Hospital Universitario RamÃ³n Y CajalMadrid, Spain, 28034 Hospital Universitario La PazMadrid, Spain, 28046 Hospital Universitario Hm Madrid SanchinarroMadrid, Spain, 28050 Taiwan Chiayi Chang Gung Memorial Hospital Of The Chang Gung Medical FoundationChiayi City, Taiwan Chang Gung Memorial Hospital, KaohsiungKaohsiung, Taiwan, 833 National Cheng Kung University HospitalTainan, Taiwan, 70403 National Taiwan University HospitalTaipei, Taiwan, 100 Taipei Veterans General HospitalTaipei, Taiwan, 11217 Chang Gung Memorial Hospital, LinkouTaoyuan, Taiwan, 333|Manchester, England, United Kingdom, M20 4Bx|London, Greater London, United Kingdom, Nw3 2Qg King'S College HospitalLondon, Greater London, United Kingdom, Se5 9Rs The Sarah Cannon Research Institute UkLondon, Greater London, United Kingdom, W1G 6Ad|Glasgow, Strathclyde, United Kingdom, G12 Oyn|Birmingham, West Midlands, United Kingdom, B15 2Th|Newcastle Upon Tyne, United Kingdom, Ne7 7Dn",null,"China|France|Germany|Italy|Poland|Spain|United Kingdom","Anhui Anhui Medical University - The Second Hospital|Chinese Pla General Hospital Medical School Of Chinese Pla|Fujian Fujian Medical University Union Hospital|Guangdong Sun Yat-Sen Memorial Hospital,Sun Yat-Sen University|Heilongjiang Harbin Medical University Cancer Hospital|Henan Henan Cancer Hospital|Hubei Union Hospital Tongji Medical College Huazhong University Of Science And Technology|Jiangsu Xuzhou Central Hospital|Jiangxi The Second Affiliated Hospital Of Nanchang University|Jilin Jilin Cancer Hospital|Shandong Weifang People's Hospital|Shanghai Shanghai Cancer Hospital, Fudan University|Tianjin Tianjin Medical University Cancer Institute & Hospital|Zhejiang The First Affiliated Hospital, Zhejiang University|Alpes Maritimes Chu Nice - HÃ´pital De L'Archet 2|Gironde Groupe Hospitalier Sud - HÃ´pital Haut LÃ©vÃªque|Herault Hopital Saint Eloi|Ille Et Vilaine Crlcc Eugene Marquis|Paris Hopital Beaujon|Rhone Centre Hospitalier De La Croix Rousse|Val De Marne Institut Gustave Roussy|Vienne Chu Poitiers - HÃ´pital La MilÃ©trie|Nordrhein Westfalen Kliniken Essen-Mitte|Rheinland Pflaz UniversitÃ¤tsmedizin Der Johannes Gutenberg-UniversitÃ¤t Mainz|Universitaetsklinikum Hamburg-Eppendorf|Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii (Presidio Papa Giovanni Xxiii)|Milano Istituto Clinico Humanitas|Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska|Barcelona Ico L'Hospitalet - Hospital Duran I Reynals|Hospital Universitari Vall D'Hebron|, England The Christie Nhs Foundation Trust|, Greater London Royal Free Hospital|, Strathclyde Beatson West Of Scotland Cancer Centre|, West Midlands Queen Elizabeth Hospital|Freeman Hospital",{"$nulls":4},"2019-07-17","2020-05-25T16:40:09.811","2020-05-26T17:10:42.972","NCT03419897"]
["5ecbf4ea11702c1b1b916c18","NCT03419897","2019-11-01","BeiGene","BGNE","Active, not recruiting","Study of BGB-A317 in Patients With Previously Treated Unresectable HCC","Tislelizumab","PD-1 Inhibitor","Yes","['Tislelizumab']","No",null,"Phase 2",1,228,"Anticipated","2018-04-09","2021-03-01","RR","Response Rate",{"$nulls":3},"This is a Phase 2, Open-label, Multicenter Study to Investigate the Efficacy, Safety, and Pharmacokinetics of the Anti-PD-1 Monoclonal Antibody BGB-A317 in Patients with Previously Treated Hepatocellular Unresectable Carcinoma.",null,"RATIONALE-208: A Phase 2, Open-label, Multicenter Study to Investigate the Efficacy, Safety, and Pharmacokinetics of the Anti-PD-1 Monoclonal Antibody BGB-A317 in Patients With Previously Treated Hepatocellular Unresectable Carcinoma","BGB-A317-208","Hepatocellular Carcinoma (HCC)","Noma|Carcinoma|Hepatocellular Carcinoma","Mouth Diseases|Oncology Solid Tumor","Ear, Nose and Throat|Oncology","Experimental","BGB-A317","BGB-A317: 200 mg once every 3 weeks (Q3W), intravenous dosing (IV)","Drug","BGB-A317","Anti-PD-1 ANTIBODY",null,"BGB-A317","\n\n 1. Histologically confirmed HCC\n 2. Patients with Barcelona Clinic Liver Cancer (BCLC) Stage C, or BCLC stage B not amenable to locoregional therapy or relapsed after locoregional therapy, and not amenable to a curative treatment approach\n 3. Has received at least 1 line of systemic therapy for unresectable HCC\n 4. Has at least 1 measurable lesion as defined per RECIST v1.1\n 5. Child-Pugh score A\n 6. Easter Cooperative Oncology Group (ECOG) Performance Status â‰¤ 1\n 7. Adequate organ function\n\n","\n\n 1. Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC histology\n 2. Prior therapies targeting PD-1 or PD-L1\n 3. Has Known brain or leptomeningeal metastasis\n 4. Tumor thrombus involving main trunk of portal vein or inferior vena cava\n 5. Loco-regional therapy to the liver within 4 weeks before enrollment\n 6. Medical history of interstitial lung disease, non-infectious pneumonitis or uncontrolled systemic diseases, including diabetes, hypertension, pulmonary fibrosis, acute lung diseases, etc\n 7. Has received: 1. Within 28 days or 5 half-lives (whichever is shorter) of the first study drug administration: any chemotherapy, immunotherapy (eg, interleukin, interferon, thymoxin) or any investigational therapies\n     2. Within 14 days of the first study drug administration: sorafenib, regorafenib, or any Chinese herbal medicine or Chinese patent medicines used to control cancer\n    \n    \n 8. Active autoimmune diseases or history of autoimmune diseases that may relapse\n 9. Patient with any condition requiring systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication within 14 days before study drug administration",{"$nulls":4},"Actual","2018-02-05","Actual","Anticipated","2021-09-01","Anticipated","2019-03-01","2018-01-29","2018-02-01","2019-10-31","Yes","Advanced liver cancer\nRATIONALE-208","Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No","Undecided",{"$nulls":3},"Yes","No",{"$nulls":17},"2017-003983-10|CTR20171257","EudraCT Number|Registry Identifier: Center for drug evaluation, CFDA","Objective Response Rate (ORR) assessed by Independent Review Committee (IRC)","From date of enrollment up to 4 years, approximately",null,"Duration of Response (DOR)|Progression-free survival (PFS)|Disease Control Rate (DCR)|Clinical benefit rate (CBR)|Overall Survival|Percentage of patients with adverse events|Health-Related Quality of Life (HRQoL)|Percentage of Participants With Clinically Significant Changes in Vital Signs Findings|Percentage of Participants With Clinically Significant Changes in Physical Examination Findings|Percentage of Participants With Clinically Significant Changes in Clinical Laboratory Results Findings|Percentage of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Findings","From first determination of an objective response up to 4 years, approximately|From date of enrollment up to 4 years, approximately|From first dose of study treatment up to 4 years, approximately|From first dose of study treatment up to 4 years, approximately.|From date of enrollment up to 4 years, approximately.|At screening or baseline up to 4 years, approximately",{"$nulls":4},"Hefei, Anhui, China, 230071 Anhui Provincial HospitalHefei, Anhui, China, 230071 The Second Hospital Of Anhui Medical HospitalHefei, Anhui, China, 230601|Beijing, China, 100853|Fuzhou, Fujian, China, 350001|Guangzhou, Guangdong, China, 510288 Nanfang Hospital Of Southern Medical UniversityGuangzhou, Guangdong, China, 510515 Peking University Shenzhen HospitalShenzhen, Guangdong, China, 518036|Harbin, Heilongjiang, China, 150081|Zhengzhou, Henan, China, 450008|Wuhan, Hubei, China, 430022 Hubei Cancer HospitalWuhan, Hubei, China, 430079|Xuzhou, Jiangsu, China, 221009|Nanchang, Jiangxi, China, 330006|Changchun, Jilin, China, 130012 The First Hospital Of Jilin UniversityChangchun, Jilin, China, 130021|Weifang, Shandong, China, 261000|Shanghai, Shanghai, China, 200032 Zhongshan Hospital Fudan UniversityShanghai, Shanghai, China, 200032|Tianjin, Tianjin, China, 300060|Hangzhou, Zhejiang, China, 310003 The Second Affiliated Hospital Of Zhejiang University School Of MedicineHangzhou, Zhejiang, China, 310009 Sir Run Run Shaw Hospital, Zhejiang University, School Of MedicineHangzhou, Zhejiang, China, 310016 Zhejiang Cancer HospitalHangzhou, Zhejiang, China, 310022 The First Affiliated Hospital Of Wenzhou Medical UniversityWenzhou, Zhejiang, China, 325000|Nice Cedex 3, Alpes Maritimes, France, 06202|Pessac Cedex, Gironde, France, 33604|Montpellier, Herault, France, 34295|Rennes Cedex, Ille Et Vilaine, France, 35042|Clichy, Paris, France, 92210|Lyon, Rhone, France, 69004 Centre Hospitalier De La Croix RousseLyon, Rhone, France, 69317|Villejuif Cedex, Val De Marne, France, 94805|Poitiers Cedex, Vienne, France, 8600|Essen, Nordrhein Westfalen, Germany, 45136|Mainz, Rheinland Pflaz, Germany, 55131|Hamburg, Germany, 20246|Bergamo, Italy, 24127 Azienda Ospedaliero Universitaria PisanaPisa, Italy, 56126 UniversitÃ  Campus Bio-Medico Di RomaRoma, Italy, 00128|Rozzano, Milano, Italy, 20089|Warszawa, Poland, 02-034 Centrum Onkologii-Instytut Im. M. Sklodowskiej CurieWroclaw, Poland, 51-162|L'Hospitalet De Llobregat, Barcelona, Spain, 08908|Barcelona, Spain, 08035 Hospital Universitario Reina SofiaCÃ³rdoba, Spain, 14004 Hospital Universitario RamÃ³n Y CajalMadrid, Spain, 28034 Hospital Universitario La PazMadrid, Spain, 28046 Hospital Universitario Hm Madrid SanchinarroMadrid, Spain, 28050 Taiwan Chiayi Chang Gung Memorial Hospital Of The Chang Gung Medical FoundationChiayi City, Taiwan Chang Gung Memorial Hospital, KaohsiungKaohsiung, Taiwan, 833 National Cheng Kung University HospitalTainan, Taiwan, 70403 National Taiwan University HospitalTaipei, Taiwan, 100 Taipei Veterans General HospitalTaipei, Taiwan, 11217 Chang Gung Memorial Hospital, LinkouTaoyuan, Taiwan, 333|Manchester, England, United Kingdom, M20 4Bx|London, Greater London, United Kingdom, Nw3 2Qg King'S College HospitalLondon, Greater London, United Kingdom, Se5 9Rs The Sarah Cannon Research Institute UkLondon, Greater London, United Kingdom, W1G 6Ad|Glasgow, Strathclyde, United Kingdom, G12 Oyn|Birmingham, West Midlands, United Kingdom, B15 2Th|Newcastle Upon Tyne, United Kingdom, Ne7 7Dn",null,"China|France|Germany|Italy|Poland|Spain|United Kingdom","Anhui Anhui Medical University - The Second Hospital|Chinese Pla General Hospital Medical School Of Chinese Pla|Fujian Fujian Medical University Union Hospital|Guangdong Sun Yat-Sen Memorial Hospital,Sun Yat-Sen University|Heilongjiang Harbin Medical University Cancer Hospital|Henan Henan Cancer Hospital|Hubei Union Hospital Tongji Medical College Huazhong University Of Science And Technology|Jiangsu Xuzhou Central Hospital|Jiangxi The Second Affiliated Hospital Of Nanchang University|Jilin Jilin Cancer Hospital|Shandong Weifang People's Hospital|Shanghai Shanghai Cancer Hospital, Fudan University|Tianjin Tianjin Medical University Cancer Institute & Hospital|Zhejiang The First Affiliated Hospital, Zhejiang University|Alpes Maritimes Chu Nice - HÃ´pital De L'Archet 2|Gironde Groupe Hospitalier Sud - HÃ´pital Haut LÃ©vÃªque|Herault Hopital Saint Eloi|Ille Et Vilaine Crlcc Eugene Marquis|Paris Hopital Beaujon|Rhone Centre Hospitalier De La Croix Rousse|Val De Marne Institut Gustave Roussy|Vienne Chu Poitiers - HÃ´pital La MilÃ©trie|Nordrhein Westfalen Kliniken Essen-Mitte|Rheinland Pflaz UniversitÃ¤tsmedizin Der Johannes Gutenberg-UniversitÃ¤t Mainz|Universitaetsklinikum Hamburg-Eppendorf|Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii (Presidio Papa Giovanni Xxiii)|Milano Istituto Clinico Humanitas|Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska|Barcelona Ico L'Hospitalet - Hospital Duran I Reynals|Hospital Universitari Vall D'Hebron|, England The Christie Nhs Foundation Trust|, Greater London Royal Free Hospital|, Strathclyde Beatson West Of Scotland Cancer Centre|, West Midlands Queen Elizabeth Hospital|Freeman Hospital",{"$nulls":4},"2019-10-31","2020-05-25T16:40:10.230","2020-05-26T17:10:42.972","NCT03419897"]
["5ecbf4eae2561b1b11905f07","NCT03419897","2019-11-04","BeiGene","BGNE","Active, not recruiting","Study of BGB-A317 in Patients With Previously Treated Unresectable HCC","Tislelizumab","PD-1 Inhibitor","Yes","['Tislelizumab']","No",null,"Phase 2",1,228,"Anticipated","2018-04-09","2021-03-01","RR","Response Rate",{"$nulls":3},"This is a Phase 2, Open-label, Multicenter Study to Investigate the Efficacy, Safety, and Pharmacokinetics of the Anti-PD-1 Monoclonal Antibody BGB-A317 in Patients with Previously Treated Hepatocellular Unresectable Carcinoma.",null,"RATIONALE-208: A Phase 2, Open-label, Multicenter Study to Investigate the Efficacy, Safety, and Pharmacokinetics of the Anti-PD-1 Monoclonal Antibody BGB-A317 in Patients With Previously Treated Hepatocellular Unresectable Carcinoma","BGB-A317-208","Hepatocellular Carcinoma (HCC)","Noma|Carcinoma|Hepatocellular Carcinoma","Mouth Diseases|Oncology Solid Tumor","Ear, Nose and Throat|Oncology","Experimental","BGB-A317","BGB-A317: 200 mg once every 3 weeks (Q3W), intravenous dosing (IV)","Drug","BGB-A317","Anti-PD-1 ANTIBODY",null,"BGB-A317","\n\n 1. Histologically confirmed HCC\n 2. Patients with Barcelona Clinic Liver Cancer (BCLC) Stage C, or BCLC stage B not amenable to locoregional therapy or relapsed after locoregional therapy, and not amenable to a curative treatment approach\n 3. Has received at least 1 line of systemic therapy for unresectable HCC\n 4. Has at least 1 measurable lesion as defined per RECIST v1.1\n 5. Child-Pugh score A\n 6. Easter Cooperative Oncology Group (ECOG) Performance Status â‰¤ 1\n 7. Adequate organ function\n\n","\n\n 1. Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC histology\n 2. Prior therapies targeting PD-1 or PD-L1\n 3. Has Known brain or leptomeningeal metastasis\n 4. Tumor thrombus involving main trunk of portal vein or inferior vena cava\n 5. Loco-regional therapy to the liver within 4 weeks before enrollment\n 6. Medical history of interstitial lung disease, non-infectious pneumonitis or uncontrolled systemic diseases, including diabetes, hypertension, pulmonary fibrosis, acute lung diseases, etc\n 7. Has received: 1. Within 28 days or 5 half-lives (whichever is shorter) of the first study drug administration: any chemotherapy, immunotherapy (eg, interleukin, interferon, thymoxin) or any investigational therapies\n     2. Within 14 days of the first study drug administration: sorafenib, regorafenib, or any Chinese herbal medicine or Chinese patent medicines used to control cancer\n    \n    \n 8. Active autoimmune diseases or history of autoimmune diseases that may relapse\n 9. Patient with any condition requiring systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication within 14 days before study drug administration",{"$nulls":4},"Actual","2018-02-05","Actual","Anticipated","2021-09-01","Anticipated","2019-03-01","2018-01-29","2018-02-01","2019-11-01","Yes","Advanced liver cancer\nRATIONALE-208","Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No","Undecided",{"$nulls":3},"Yes","No",{"$nulls":17},"2017-003983-10|CTR20171257","EudraCT Number|Registry Identifier: Center for drug evaluation, CFDA","Objective Response Rate (ORR) assessed by Independent Review Committee (IRC)","From date of enrollment up to 4 years, approximately",null,"Duration of Response (DOR)|Progression-free survival (PFS)|Disease Control Rate (DCR)|Clinical benefit rate (CBR)|Overall Survival|Percentage of patients with adverse events|Health-Related Quality of Life (HRQoL)|Percentage of Participants With Clinically Significant Changes in Vital Signs Findings|Percentage of Participants With Clinically Significant Changes in Physical Examination Findings|Percentage of Participants With Clinically Significant Changes in Clinical Laboratory Results Findings|Percentage of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Findings","From first determination of an objective response up to 4 years, approximately|From date of enrollment up to 4 years, approximately|From first dose of study treatment up to 4 years, approximately|From first dose of study treatment up to 4 years, approximately.|From date of enrollment up to 4 years, approximately.|At screening or baseline up to 4 years, approximately",{"$nulls":4},"Hefei, Anhui, China, 230071 Anhui Provincial HospitalHefei, Anhui, China, 230071 The Second Hospital Of Anhui Medical HospitalHefei, Anhui, China, 230601|Beijing, China, 100853|Fuzhou, Fujian, China, 350001|Guangzhou, Guangdong, China, 510288 Nanfang Hospital Of Southern Medical UniversityGuangzhou, Guangdong, China, 510515 Peking University Shenzhen HospitalShenzhen, Guangdong, China, 518036|Harbin, Heilongjiang, China, 150081|Zhengzhou, Henan, China, 450008|Wuhan, Hubei, China, 430022 Hubei Cancer HospitalWuhan, Hubei, China, 430079|Xuzhou, Jiangsu, China, 221009|Nanchang, Jiangxi, China, 330006|Changchun, Jilin, China, 130012 The First Hospital Of Jilin UniversityChangchun, Jilin, China, 130021|Weifang, Shandong, China, 261000|Shanghai, Shanghai, China, 200032 Zhongshan Hospital Fudan UniversityShanghai, Shanghai, China, 200032|Tianjin, Tianjin, China, 300060|Hangzhou, Zhejiang, China, 310003 The Second Affiliated Hospital Of Zhejiang University School Of MedicineHangzhou, Zhejiang, China, 310009 Sir Run Run Shaw Hospital, Zhejiang University, School Of MedicineHangzhou, Zhejiang, China, 310016 Zhejiang Cancer HospitalHangzhou, Zhejiang, China, 310022 The First Affiliated Hospital Of Wenzhou Medical UniversityWenzhou, Zhejiang, China, 325000|Nice Cedex 3, Alpes Maritimes, France, 06202|Pessac Cedex, Gironde, France, 33604|Montpellier, Herault, France, 34295|Rennes Cedex, Ille Et Vilaine, France, 35042|Clichy, Paris, France, 92210|Lyon, Rhone, France, 69004 Centre Hospitalier De La Croix RousseLyon, Rhone, France, 69317|Villejuif Cedex, Val De Marne, France, 94805|Poitiers Cedex, Vienne, France, 8600|Essen, Nordrhein Westfalen, Germany, 45136|Mainz, Rheinland Pflaz, Germany, 55131|Hamburg, Germany, 20246|Bergamo, Italy, 24127 Azienda Ospedaliero Universitaria PisanaPisa, Italy, 56126 UniversitÃ  Campus Bio-Medico Di RomaRoma, Italy, 00128|Rozzano, Milano, Italy, 20089|Warszawa, Poland, 02-034 Centrum Onkologii-Instytut Im. M. Sklodowskiej CurieWroclaw, Poland, 51-162|L'Hospitalet De Llobregat, Barcelona, Spain, 08908|Barcelona, Spain, 08035 Hospital Universitario Reina SofiaCÃ³rdoba, Spain, 14004 Hospital Universitario RamÃ³n Y CajalMadrid, Spain, 28034 Hospital Universitario La PazMadrid, Spain, 28046 Hospital Universitario Hm Madrid SanchinarroMadrid, Spain, 28050 Taiwan Chiayi Chang Gung Memorial Hospital Of The Chang Gung Medical FoundationChiayi City, Taiwan Chang Gung Memorial Hospital, KaohsiungKaohsiung, Taiwan, 833 National Cheng Kung University HospitalTainan, Taiwan, 70403 National Taiwan University HospitalTaipei, Taiwan, 100 Taipei Veterans General HospitalTaipei, Taiwan, 11217 Chang Gung Memorial Hospital, LinkouTaoyuan, Taiwan, 333|Manchester, England, United Kingdom, M20 4Bx|London, Greater London, United Kingdom, Nw3 2Qg King'S College HospitalLondon, Greater London, United Kingdom, Se5 9Rs The Sarah Cannon Research Institute UkLondon, Greater London, United Kingdom, W1G 6Ad|Glasgow, Strathclyde, United Kingdom, G12 Oyn|Birmingham, West Midlands, United Kingdom, B15 2Th|Newcastle Upon Tyne, United Kingdom, Ne7 7Dn",null,"China|France|Germany|Italy|Poland|Spain|United Kingdom","Anhui Anhui Medical University - The Second Hospital|Chinese Pla General Hospital Medical School Of Chinese Pla|Fujian Fujian Medical University Union Hospital|Guangdong Sun Yat-Sen Memorial Hospital,Sun Yat-Sen University|Heilongjiang Harbin Medical University Cancer Hospital|Henan Henan Cancer Hospital|Hubei Union Hospital Tongji Medical College Huazhong University Of Science And Technology|Jiangsu Xuzhou Central Hospital|Jiangxi The Second Affiliated Hospital Of Nanchang University|Jilin Jilin Cancer Hospital|Shandong Weifang People's Hospital|Shanghai Shanghai Cancer Hospital, Fudan University|Tianjin Tianjin Medical University Cancer Institute & Hospital|Zhejiang The First Affiliated Hospital, Zhejiang University|Alpes Maritimes Chu Nice - HÃ´pital De L'Archet 2|Gironde Groupe Hospitalier Sud - HÃ´pital Haut LÃ©vÃªque|Herault Hopital Saint Eloi|Ille Et Vilaine Crlcc Eugene Marquis|Paris Hopital Beaujon|Rhone Centre Hospitalier De La Croix Rousse|Val De Marne Institut Gustave Roussy|Vienne Chu Poitiers - HÃ´pital La MilÃ©trie|Nordrhein Westfalen Kliniken Essen-Mitte|Rheinland Pflaz UniversitÃ¤tsmedizin Der Johannes Gutenberg-UniversitÃ¤t Mainz|Universitaetsklinikum Hamburg-Eppendorf|Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii (Presidio Papa Giovanni Xxiii)|Milano Istituto Clinico Humanitas|Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska|Barcelona Ico L'Hospitalet - Hospital Duran I Reynals|Hospital Universitari Vall D'Hebron|, England The Christie Nhs Foundation Trust|, Greater London Royal Free Hospital|, Strathclyde Beatson West Of Scotland Cancer Centre|, West Midlands Queen Elizabeth Hospital|Freeman Hospital",{"$nulls":4},"2019-11-01","2020-05-25T16:40:10.338","2020-05-26T17:10:42.972","NCT03419897"]
["5ecbf4e9fe30261b1a04840c","NCT03419897","2019-11-18","BeiGene","BGNE","Active, not recruiting","Study of BGB-A317 in Patients With Previously Treated Unresectable HCC","Tislelizumab","PD-1 Inhibitor","Yes","['Tislelizumab']","No",null,"Phase 2",1,228,"Anticipated","2018-04-09","2021-03-01","RR","Response Rate",{"$nulls":3},"This is a Phase 2, Open-label, Multicenter Study to Investigate the Efficacy, Safety, and Pharmacokinetics of the Anti-PD-1 Monoclonal Antibody BGB-A317 in Patients with Previously Treated Hepatocellular Unresectable Carcinoma.",null,"RATIONALE-208: A Phase 2, Open-label, Multicenter Study to Investigate the Efficacy, Safety, and Pharmacokinetics of the Anti-PD-1 Monoclonal Antibody BGB-A317 in Patients With Previously Treated Hepatocellular Unresectable Carcinoma","BGB-A317-208","Hepatocellular Carcinoma (HCC)","Noma|Carcinoma|Hepatocellular Carcinoma","Mouth Diseases|Oncology Solid Tumor","Ear, Nose and Throat|Oncology","Experimental","BGB-A317","BGB-A317: 200 mg once every 3 weeks (Q3W), intravenous dosing (IV)","Drug","BGB-A317","Anti-PD-1 ANTIBODY",null,"BGB-A317","\n\n 1. Histologically confirmed HCC\n 2. Patients with Barcelona Clinic Liver Cancer (BCLC) Stage C, or BCLC stage B not amenable to locoregional therapy or relapsed after locoregional therapy, and not amenable to a curative treatment approach\n 3. Has received at least 1 line of systemic therapy for unresectable HCC\n 4. Has at least 1 measurable lesion as defined per RECIST v1.1\n 5. Child-Pugh score A\n 6. Easter Cooperative Oncology Group (ECOG) Performance Status â‰¤ 1\n 7. Adequate organ function\n\n","\n\n 1. Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC histology\n 2. Prior therapies targeting PD-1 or PD-L1\n 3. Has Known brain or leptomeningeal metastasis\n 4. Tumor thrombus involving main trunk of portal vein or inferior vena cava\n 5. Loco-regional therapy to the liver within 4 weeks before enrollment\n 6. Medical history of interstitial lung disease, non-infectious pneumonitis or uncontrolled systemic diseases, including diabetes, hypertension, pulmonary fibrosis, acute lung diseases, etc\n 7. Has received: 1. Within 28 days or 5 half-lives (whichever is shorter) of the first study drug administration: any chemotherapy, immunotherapy (eg, interleukin, interferon, thymoxin) or any investigational therapies\n     2. Within 14 days of the first study drug administration: sorafenib, regorafenib, or any Chinese herbal medicine or Chinese patent medicines used to control cancer\n    \n    \n 8. Active autoimmune diseases or history of autoimmune diseases that may relapse\n 9. Patient with any condition requiring systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication within 14 days before study drug administration",{"$nulls":4},"Actual","2018-02-05","Actual","Anticipated","2021-09-01","Anticipated","2019-03-01","2018-01-29","2018-02-01","2019-11-15","Yes","Advanced liver cancer\nRATIONALE-208","Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No","Undecided",{"$nulls":3},"Yes","No",{"$nulls":17},"2017-003983-10|CTR20171257","EudraCT Number|Registry Identifier: Center for drug evaluation, CFDA","Objective Response Rate (ORR) assessed by Independent Review Committee (IRC)","From date of enrollment up to 4 years, approximately",null,"Duration of Response (DOR)|Progression-free survival (PFS)|Disease Control Rate (DCR)|Clinical benefit rate (CBR)|Overall Survival|Percentage of patients with adverse events|Health-Related Quality of Life (HRQoL)|Percentage of Participants With Clinically Significant Changes in Vital Signs Findings|Percentage of Participants With Clinically Significant Changes in Physical Examination Findings|Percentage of Participants With Clinically Significant Changes in Clinical Laboratory Results Findings|Percentage of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Findings","From first determination of an objective response up to 4 years, approximately|From date of enrollment up to 4 years, approximately|From first dose of study treatment up to 4 years, approximately|From first dose of study treatment up to 4 years, approximately.|From date of enrollment up to 4 years, approximately.|At screening or baseline up to 4 years, approximately",{"$nulls":4},"Hefei, Anhui, China, 230071 Anhui Provincial HospitalHefei, Anhui, China, 230071 The Second Hospital Of Anhui Medical HospitalHefei, Anhui, China, 230601|Beijing, China, 100853|Fuzhou, Fujian, China, 350001|Guangzhou, Guangdong, China, 510288 Nanfang Hospital Of Southern Medical UniversityGuangzhou, Guangdong, China, 510515 Peking University Shenzhen HospitalShenzhen, Guangdong, China, 518036|Harbin, Heilongjiang, China, 150081|Zhengzhou, Henan, China, 450008|Wuhan, Hubei, China, 430022 Hubei Cancer HospitalWuhan, Hubei, China, 430079|Xuzhou, Jiangsu, China, 221009|Nanchang, Jiangxi, China, 330006|Changchun, Jilin, China, 130012 The First Hospital Of Jilin UniversityChangchun, Jilin, China, 130021|Weifang, Shandong, China, 261000|Shanghai, Shanghai, China, 200032 Zhongshan Hospital Fudan UniversityShanghai, Shanghai, China, 200032|Tianjin, Tianjin, China, 300060|Hangzhou, Zhejiang, China, 310003 The Second Affiliated Hospital Of Zhejiang University School Of MedicineHangzhou, Zhejiang, China, 310009 Sir Run Run Shaw Hospital, Zhejiang University, School Of MedicineHangzhou, Zhejiang, China, 310016 Zhejiang Cancer HospitalHangzhou, Zhejiang, China, 310022 The First Affiliated Hospital Of Wenzhou Medical UniversityWenzhou, Zhejiang, China, 325000|Nice Cedex 3, Alpes Maritimes, France, 06202|Pessac Cedex, Gironde, France, 33604|Montpellier, Herault, France, 34295|Rennes Cedex, Ille Et Vilaine, France, 35042|Clichy, Paris, France, 92210|Lyon, Rhone, France, 69004 Centre Hospitalier De La Croix RousseLyon, Rhone, France, 69317|Villejuif Cedex, Val De Marne, France, 94805|Poitiers Cedex, Vienne, France, 8600|Essen, Nordrhein Westfalen, Germany, 45136|Mainz, Rheinland Pflaz, Germany, 55131|Hamburg, Germany, 20246|Bergamo, Italy, 24127 Azienda Ospedaliero Universitaria PisanaPisa, Italy, 56126 UniversitÃ  Campus Bio-Medico Di RomaRoma, Italy, 00128|Rozzano, Milano, Italy, 20089|Warszawa, Poland, 02-034 Centrum Onkologii-Instytut Im. M. Sklodowskiej CurieWroclaw, Poland, 51-162|L'Hospitalet De Llobregat, Barcelona, Spain, 08908|Barcelona, Spain, 08035 Hospital Universitario Reina SofiaCÃ³rdoba, Spain, 14004 Hospital Universitario RamÃ³n Y CajalMadrid, Spain, 28034 Hospital Universitario La PazMadrid, Spain, 28046 Hospital Universitario Hm Madrid SanchinarroMadrid, Spain, 28050 Taiwan Chiayi Chang Gung Memorial Hospital Of The Chang Gung Medical FoundationChiayi City, Taiwan Chang Gung Memorial Hospital, KaohsiungKaohsiung, Taiwan, 833 National Cheng Kung University HospitalTainan, Taiwan, 70403 National Taiwan University HospitalTaipei, Taiwan, 100 Taipei Veterans General HospitalTaipei, Taiwan, 11217 Chang Gung Memorial Hospital, LinkouTaoyuan, Taiwan, 333|Manchester, England, United Kingdom, M20 4Bx|London, Greater London, United Kingdom, Nw3 2Qg King'S College HospitalLondon, Greater London, United Kingdom, Se5 9Rs The Sarah Cannon Research Institute UkLondon, Greater London, United Kingdom, W1G 6Ad|Glasgow, Strathclyde, United Kingdom, G12 Oyn|Birmingham, West Midlands, United Kingdom, B15 2Th|Newcastle Upon Tyne, United Kingdom, Ne7 7Dn",null,"China|France|Germany|Italy|Poland|Spain|United Kingdom","Anhui Anhui Medical University - The Second Hospital|Chinese Pla General Hospital Medical School Of Chinese Pla|Fujian Fujian Medical University Union Hospital|Guangdong Sun Yat-Sen Memorial Hospital,Sun Yat-Sen University|Heilongjiang Harbin Medical University Cancer Hospital|Henan Henan Cancer Hospital|Hubei Union Hospital Tongji Medical College Huazhong University Of Science And Technology|Jiangsu Xuzhou Central Hospital|Jiangxi The Second Affiliated Hospital Of Nanchang University|Jilin Jilin Cancer Hospital|Shandong Weifang People's Hospital|Shanghai Shanghai Cancer Hospital, Fudan University|Tianjin Tianjin Medical University Cancer Institute & Hospital|Zhejiang The First Affiliated Hospital, Zhejiang University|Alpes Maritimes Chu Nice - HÃ´pital De L'Archet 2|Gironde Groupe Hospitalier Sud - HÃ´pital Haut LÃ©vÃªque|Herault Hopital Saint Eloi|Ille Et Vilaine Crlcc Eugene Marquis|Paris Hopital Beaujon|Rhone Centre Hospitalier De La Croix Rousse|Val De Marne Institut Gustave Roussy|Vienne Chu Poitiers - HÃ´pital La MilÃ©trie|Nordrhein Westfalen Kliniken Essen-Mitte|Rheinland Pflaz UniversitÃ¤tsmedizin Der Johannes Gutenberg-UniversitÃ¤t Mainz|Universitaetsklinikum Hamburg-Eppendorf|Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii (Presidio Papa Giovanni Xxiii)|Milano Istituto Clinico Humanitas|Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska|Barcelona Ico L'Hospitalet - Hospital Duran I Reynals|Hospital Universitari Vall D'Hebron|, England The Christie Nhs Foundation Trust|, Greater London Royal Free Hospital|, Strathclyde Beatson West Of Scotland Cancer Centre|, West Midlands Queen Elizabeth Hospital|Freeman Hospital",{"$nulls":4},"2019-11-15","2020-05-25T16:40:09.995","2020-05-26T17:10:42.972","NCT03419897"]
["5ecbf4eafeab101b15530a3b","NCT03419897","2020-04-24","BeiGene","BGNE","Active, not recruiting","Study of BGB-A317 in Participants With Previously Treated Unresectable HCC","Tislelizumab","PD-1 Inhibitor","Yes","['Tislelizumab']","No",null,"Phase 2",1,249,"Actual","2018-04-09","2021-04-01","RR","Response Rate",{"$nulls":3},"This is a Phase 2, Open-label, Multicenter Study to Investigate the Efficacy, Safety, and Pharmacokinetics of the Anti-PD-1 Monoclonal Antibody BGB-A317 in Participants with Previously Treated Hepatocellular Unresectable Carcinoma.",null,"RATIONALE-208: A Phase 2, Open-label, Multicenter Study to Investigate the Efficacy, Safety, and Pharmacokinetics of the Anti-PD-1 Monoclonal Antibody BGB-A317 in Patients With Previously Treated Hepatocellular Unresectable Carcinoma","BGB-A317-208","Hepatocellular Carcinoma (HCC)","Noma|Carcinoma|Hepatocellular Carcinoma","Mouth Diseases|Oncology Solid Tumor","Ear, Nose and Throat|Oncology","Experimental","Tislelizumab","200 mg once every 3 weeks (Q3W), intravenous dosing (IV)","Drug","Tislelizumab","Anti-PD-1 ANTIBODY","BGB-A317","Tislelizumab","\n\n 1. Histologically confirmed HCC\n 2. Participants with Barcelona Clinic Liver Cancer (BCLC) Stage C, or BCLC stage B not amenable to locoregional therapy or relapsed after locoregional therapy, and not amenable to a curative treatment approach\n 3. Has received at least 1 line of systemic therapy for unresectable HCC\n 4. Has at least 1 measurable lesion as defined per RECIST v1.1\n 5. Child-Pugh score A\n 6. Easter Cooperative Oncology Group (ECOG) Performance Status â‰¤ 1\n 7. Adequate organ function\n\nKey ","\n\n 1. Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC histology\n 2. Prior therapies targeting PD-1 or PD-L1\n 3. Has Known brain or leptomeningeal metastasis\n 4. Tumor thrombus involving main trunk of portal vein or inferior vena cava\n 5. Loco-regional therapy to the liver within 4 weeks before enrollment\n 6. Medical history of interstitial lung disease, non-infectious pneumonitis or uncontrolled systemic diseases, including diabetes, hypertension, pulmonary fibrosis, acute lung diseases, etc\n 7. Has received: 1. Within 28 days or 5 half-lives (whichever is shorter) of the first study drug administration: any chemotherapy, immunotherapy (eg, interleukin, interferon, thymoxin) or any investigational therapies\n     2. Within 14 days of the first study drug administration: sorafenib, regorafenib, or any Chinese herbal medicine or Chinese patent medicines used to control cancer\n    \n    \n 8. Active autoimmune diseases or history of autoimmune diseases that may relapse\n 9. Participant with any condition requiring systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication within 14 days before study drug administration\n\nNOTE: Other protocol defined Inclusion/Exclusion criteria may apply.",{"$nulls":4},"Actual","2018-02-05","Actual","Anticipated","2021-09-01","Anticipated","2020-04-01","2018-01-29","2018-02-01","2020-04-22","Yes","Advanced liver cancer\nRATIONALE-208","Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No","Yes",{"$nulls":3},"Yes","No",{"$nulls":17},"2017-003983-10|CTR20171257","EudraCT Number|Registry Identifier: Center for drug evaluation, CFDA","Objective Response Rate (ORR) assessed by Independent Review Committee (IRC)","From date of enrollment up to 4 years, approximately",null,"Duration of Response (DOR)|Progression-free survival (PFS)|Disease Control Rate (DCR)|Clinical benefit rate (CBR)|Overall Survival|Percentage of participants with adverse events|Health-Related Quality of Life (HRQoL)|Percentage of Participants With Clinically Significant Changes in Vital Signs Findings|Percentage of Participants With Clinically Significant Changes in Physical Examination Findings|Percentage of Participants With Clinically Significant Changes in Clinical Laboratory Results Findings|Percentage of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Findings","From first determination of an objective response up to 4 years, approximately|From date of enrollment up to 4 years, approximately|From first dose of study treatment up to 4 years, approximately|From first dose of study treatment up to 4 years, approximately.|From date of enrollment up to 4 years, approximately.|At screening or baseline up to 4 years, approximately",{"$nulls":4},"Hefei, Anhui, China, 230071 The Second Hospital Of Anhui Medical HospitalHefei, Anhui, China, 230601|Beijing, China, 100853|Fuzhou, Fujian, China, 350001|Guangzhou, Guangdong, China, 510288 Nanfang Hospital Of Southern Medical UniversityGuangzhou, Guangdong, China, 510515 Peking University Shenzhen HospitalShenzhen, Guangdong, China, 518036|Harbin, Heilongjiang, China, 150081|Zhengzhou, Henan, China, 450008|Wuhan, Hubei, China, 430022 Hubei Cancer HospitalWuhan, Hubei, China, 430079|Xuzhou, Jiangsu, China, 221009|Nanchang, Jiangxi, China, 330006 The First Affiliated Hospital Of Nanchang UniversityNanchang, Jiangxi, China|Changchun, Jilin, China, 130012 The First Hospital Of Jilin UniversityChangchun, Jilin, China, 130021|Weifang, Shandong, China, 261000|Shanghai, Shanghai, China, 200032 Zhongshan Hospital Fudan UniversityShanghai, Shanghai, China, 200032|Tianjin, Tianjin, China, 300060|Hangzhou, Zhejiang, China, 310003 The Second Affiliated Hospital Of Zhejiang University School Of MedicineHangzhou, Zhejiang, China, 310009 Sir Run Run Shaw Hospital, Zhejiang University, School Of MedicineHangzhou, Zhejiang, China, 310016 Zhejiang Cancer HospitalHangzhou, Zhejiang, China, 310022 The First Affiliated Hospital Of Wenzhou Medical UniversityWenzhou, Zhejiang, China, 325000|Nice Cedex 3, Alpes Maritimes, France, 06202|Pessac Cedex, Gironde, France, 33604|Montpellier, Herault, France, 34295|Rennes Cedex, Ille Et Vilaine, France, 35042|Clichy, Paris, France, 92210|Lyon, Rhone, France, 69004 Centre Hospitalier De La Croix RousseLyon, Rhone, France, 69317|Villejuif Cedex, Val De Marne, France, 94805|Poitiers Cedex, Vienne, France, 8600|Essen, Nordrhein Westfalen, Germany, 45136|Mainz, Rheinland Pflaz, Germany, 55131|Hamburg, Germany, 20246|Bergamo, Italy, 24127 Azienda Ospedaliero Universitaria PisanaPisa, Italy, 56126 UniversitÃ  Campus Bio-Medico Di RomaRoma, Italy, 00128|Rozzano, Milano, Italy, 20089|Warszawa, Poland, 02-034 Centrum Onkologii-Instytut Im. M. Sklodowskiej CurieWroclaw, Poland, 51-162|L'Hospitalet De Llobregat, Barcelona, Spain, 08908|Barcelona, Spain, 08035 Hospital Universitario Reina SofiaCÃ³rdoba, Spain, 14004 Hospital Universitario RamÃ³n Y CajalMadrid, Spain, 28034 Hospital Universitario La PazMadrid, Spain, 28046 Hospital Universitario Hm Madrid SanchinarroMadrid, Spain, 28050 Taiwan Chiayi Chang Gung Memorial Hospital Of The Chang Gung Medical FoundationChiayi City, Taiwan E-Da Cancer HospitalKaohsiung, Taiwan, 803 Chang Gung Memorial Hospital, KaohsiungKaohsiung, Taiwan, 833 National Cheng Kung University HospitalTainan, Taiwan, 70403 National Taiwan University HospitalTaipei, Taiwan, 100 Taipei Veterans General HospitalTaipei, Taiwan, 11217 Chang Gung Memorial Hospital, LinkouTaoyuan, Taiwan, 333|Manchester, England, United Kingdom, M20 4Bx|London, Greater London, United Kingdom, Nw3 2Qg King'S College HospitalLondon, Greater London, United Kingdom, Se5 9Rs|Glasgow, Strathclyde, United Kingdom, G12 Oyn|Birmingham, West Midlands, United Kingdom, B15 2Th|Newcastle Upon Tyne, United Kingdom, Ne7 7Dn",null,"China|France|Germany|Italy|Poland|Spain|United Kingdom","Anhui Anhui Provincial Hospital|Chinese Pla General Hospital Medical School Of Chinese Pla|Fujian Fujian Medical University Union Hospital|Guangdong Sun Yat-Sen Memorial Hospital,Sun Yat-Sen University|Heilongjiang Harbin Medical University Cancer Hospital|Henan Henan Cancer Hospital|Hubei Union Hospital Tongji Medical College Huazhong University Of Science And Technology|Jiangsu Xuzhou Central Hospital|Jiangxi The Second Affiliated Hospital Of Nanchang University|Jilin Jilin Cancer Hospital|Shandong Weifang People's Hospital|Shanghai Shanghai Cancer Hospital, Fudan University|Tianjin Tianjin Medical University Cancer Institute & Hospital|Zhejiang The First Affiliated Hospital, Zhejiang University|Alpes Maritimes Chu Nice - HÃ´pital De L'Archet 2|Gironde Groupe Hospitalier Sud - HÃ´pital Haut LÃ©vÃªque|Herault Hopital Saint Eloi|Ille Et Vilaine Crlcc Eugene Marquis|Paris Hopital Beaujon|Rhone Centre Hospitalier De La Croix Rousse|Val De Marne Institut Gustave Roussy|Vienne Chu Poitiers - HÃ´pital La MilÃ©trie|Nordrhein Westfalen Kliniken Essen-Mitte|Rheinland Pflaz UniversitÃ¤tsmedizin Der Johannes Gutenberg-UniversitÃ¤t Mainz|Universitaetsklinikum Hamburg-Eppendorf|Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii (Presidio Papa Giovanni Xxiii)|Milano Istituto Clinico Humanitas|Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska|Barcelona Ico L'Hospitalet - Hospital Duran I Reynals|Hospital Universitari Vall D'Hebron|, England The Christie Nhs Foundation Trust|, Greater London Royal Free Hospital|, Strathclyde Beatson West Of Scotland Cancer Centre|, West Midlands Queen Elizabeth Hospital|Freeman Hospital",{"$nulls":4},"2020-04-22","2020-05-25T16:40:10.105","2020-05-26T17:10:42.972","NCT03419897"]
["5ecbf4eafe30261b1a04840e","NCT03419910","2018-02-05","Bristol-Myers Squibb","BMY","Not yet recruiting","An Investigational Study of Cyclosporine on Experimental Medication BMS-986165 in Healthy Male Participants","Bms-986165|Cyclosporin a","TYK2 Inhibitor|Calcineurin Inhibitor|Immunosuppressive","Yes","['Bms-986165']","Yes","['TYK2 Inhibitor']","Phase 1",1,20,"Anticipated","2018-02-28","2018-04-01","AUC","Area Under The Curve",{"$nulls":3},"This is an investigational study of Cyclosporine on the experimental medication BMS-986165 in healthy male participants.",null,"An Open-Label, Single-Sequence Study to Investigate the Effects of Cyclosporine on the Pharmacokinetics of BMS-986165 at Steady State in Healthy Male Participants","IM011-045","Psoriasis","Psoriasis","Dermatological Diseases","Derm & Connective Tissue Disorders","Experimental","BMS-986165 and cyclosporine","BMS-986165 and cyclosporine administered orally","Drug","BMS-986165|Cyclosporine","Specified dose on specified days",null,"BMS-986165 and cyclosporine","\n\n * Healthy participant, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations\n * Body mass index 18.0 to 32.0 kg/m2\n * Weight â‰¥ 50 kg\n\n","\n\n * Any medical condition that presents a potential risk to the subject and/or may compromise the objectives of the study, including a history of or active liver disease\n * History or presence of acute or chronic bacterial, fungal, or viral infection (eg, pneumonia, septicemia) within the 3 months prior to screening\n * Known or suspected autoimmune disorder, or any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the participant's immune status\n * History of administration of live vaccines within 60 days before screening\n * Any history or risk for tuberculosis (TB)\n\nOther protocol defined inclusion/exclusion criteria could apply",{"$nulls":4},"Actual","2018-02-05","Actual","Anticipated","2018-04-02","Anticipated","2018-01-01","2018-01-29","2018-01-29","2018-01-29","No",null,"Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","18 Years","50 Years","Male",null,"Yes",null,null,"URL: http://bms.com/studyconnect/Pages/home.aspx [http://bms.com/studyconnect/Pages/home.aspx] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: BMS Clinical Trial Patient Recruiting",null,"Yes","No",{"$nulls":19},"Maximum concentration (Cmax)|Area under the concentration vs time curve from time zero to 24 hours post dose (AUC[0-24])","24 hours",null,"Adverse events (AEs)","Up to 20 days",null,"Clinical.Trials@bms.com","Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,","please email:","Salt Lake City, Utah, United States, 84107","Utah","United States","Local Institution",null,"First line of the email MUST contain NCT # and Site #.",null,"Bristol-Myers Squibb","2018-01-29","2020-05-25T16:40:10.797","2020-05-26T17:10:42.972","NCT03419910"]
["5ecbf4eafe30261b1a04840d","NCT03419910","2018-02-19","Bristol-Myers Squibb","BMY","Not yet recruiting","An Investigational Study of Cyclosporine on Experimental Medication BMS-986165 in Healthy Male Participants","Bms-986165|Cyclosporin a","TYK2 Inhibitor|Calcineurin Inhibitor|Immunosuppressive","Yes","['Bms-986165']","Yes","['TYK2 Inhibitor']","Phase 1",1,20,"Anticipated","2018-02-28","2018-04-01","AUC","Area Under The Curve",{"$nulls":3},"This is an investigational study of Cyclosporine on the experimental medication BMS-986165 in healthy male participants.",null,"An Open-Label, Single-Sequence Study to Investigate the Effects of Cyclosporine on the Pharmacokinetics of BMS-986165 at Steady State in Healthy Male Participants","IM011-045","Psoriasis","Psoriasis","Dermatological Diseases","Derm & Connective Tissue Disorders","Experimental","BMS-986165 and cyclosporine","BMS-986165 and cyclosporine administered orally","Drug","BMS-986165|Cyclosporine","Specified dose on specified days",null,"BMS-986165 and cyclosporine","\n\n * Healthy participant, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations\n * Body mass index 18.0 to 32.0 kg/m2\n * Weight â‰¥ 50 kg\n\n","\n\n * Any medical condition that presents a potential risk to the subject and/or may compromise the objectives of the study, including a history of or active liver disease\n * History or presence of acute or chronic bacterial, fungal, or viral infection (eg, pneumonia, septicemia) within the 3 months prior to screening\n * Known or suspected autoimmune disorder, or any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the participant's immune status\n * History of administration of live vaccines within 60 days before screening\n * Any history or risk for tuberculosis (TB)\n\nOther protocol defined inclusion/exclusion criteria could apply",{"$nulls":4},"Actual","2018-02-05","Actual","Anticipated","2018-04-02","Anticipated","2018-02-01","2018-01-29","2018-01-29","2018-02-15","No",null,"Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","18 Years","50 Years","Male",null,"Yes",null,null,"URL: http://bms.com/studyconnect/Pages/home.aspx [http://bms.com/studyconnect/Pages/home.aspx] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: BMS Clinical Trial Patient Recruiting",null,"Yes","No",{"$nulls":19},"Maximum concentration (Cmax)|Area under the concentration vs time curve from time zero to 24 hours post dose (AUC[0-24])","24 hours",null,"Adverse events (AEs)","Up to 20 days",null,"Clinical.Trials@bms.com","Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,","please email:","Salt Lake City, Utah, United States, 84107","Utah","United States","Local Institution",null,"First line of the email MUST contain NCT # and Site #.",null,"Bristol-Myers Squibb","2018-02-15","2020-05-25T16:40:10.500","2020-05-26T17:10:42.972","NCT03419910"]
["5ecbf4eafeab101b15530a3c","NCT03419910","2018-03-15","Bristol-Myers Squibb","BMY","Recruiting","An Investigational Study of Cyclosporine on Experimental Medication BMS-986165 in Healthy Male Participants","Bms-986165|Cyclosporin a","TYK2 Inhibitor|Calcineurin Inhibitor|Immunosuppressive","Yes","['Bms-986165']","Yes","['TYK2 Inhibitor']","Phase 1",1,20,"Anticipated","2018-03-05","2018-04-23","AUC","Area Under The Curve",{"$nulls":3},"This is an investigational study of Cyclosporine on the experimental medication BMS-986165 in healthy male participants.",null,"An Open-Label, Single-Sequence Study to Investigate the Effects of Cyclosporine on the Pharmacokinetics of BMS-986165 at Steady State in Healthy Male Participants","IM011-045","Psoriasis","Psoriasis","Dermatological Diseases","Derm & Connective Tissue Disorders","Experimental","BMS-986165 and cyclosporine","BMS-986165 and cyclosporine administered orally","Drug","BMS-986165|Cyclosporine","Specified dose on specified days",null,"BMS-986165 and cyclosporine","\n\n * Healthy participant, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations\n * Body mass index 18.0 to 32.0 kg/m2\n * Weight â‰¥ 50 kg\n\n","\n\n * Any medical condition that presents a potential risk to the subject and/or may compromise the objectives of the study, including a history of or active liver disease\n * History or presence of acute or chronic bacterial, fungal, or viral infection (eg, pneumonia, septicemia) within the 3 months prior to screening\n * Known or suspected autoimmune disorder, or any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the participant's immune status\n * History of administration of live vaccines within 60 days before screening\n * Any history or risk for tuberculosis (TB)\n\nOther protocol defined inclusion/exclusion criteria could apply",{"$nulls":4},"Actual","2018-02-05","Actual","Anticipated","2018-04-24","Anticipated","2018-03-01","2018-01-29","2018-01-29","2018-03-13","No",null,"Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","18 Years","50 Years","Male",null,"Yes",null,null,"URL: http://bms.com/studyconnect/Pages/home.aspx [http://bms.com/studyconnect/Pages/home.aspx] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: BMS Clinical Trial Patient Recruiting",null,"Yes","No",{"$nulls":19},"Maximum concentration (Cmax)|Area under the concentration vs time curve from time zero to 24 hours post dose (AUC[0-24])","24 hours",null,"Adverse events (AEs)","Up to 20 days",null,"Clinical.Trials@bms.com","Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,","please email:","Salt Lake City, Utah, United States, 84107","Utah","United States","Pra Health Sciences",null,"First line of the email MUST contain NCT # and Site #.",null,"Bristol-Myers Squibb","2018-03-13","2020-05-25T16:40:10.371","2020-05-26T17:10:42.972","NCT03419910"]
["5ecbf4ea307e3d1b1f8d9e9e","NCT03419910","2018-03-29","Bristol-Myers Squibb","BMY","Recruiting","An Investigational Study of Cyclosporine on Experimental Medication BMS-986165 in Healthy Male Participants","Bms-986165|Cyclosporin a","TYK2 Inhibitor|Calcineurin Inhibitor|Immunosuppressive","Yes","['Bms-986165']","Yes","['TYK2 Inhibitor']","Phase 1",1,20,"Anticipated","2018-03-05","2018-04-10","AUC","Area Under The Curve",{"$nulls":3},"This is an investigational study of Cyclosporine on the experimental medication BMS-986165 in healthy male participants.",null,"An Open-Label, Single-Sequence Study to Investigate the Effects of Cyclosporine on the Pharmacokinetics of BMS-986165 at Steady State in Healthy Male Participants","IM011-045","Psoriasis","Psoriasis","Dermatological Diseases","Derm & Connective Tissue Disorders","Experimental","BMS-986165 and cyclosporine","BMS-986165 and cyclosporine administered orally","Drug","BMS-986165|Cyclosporine","Specified dose on specified days",null,"BMS-986165 and cyclosporine","\n\n * Healthy participant, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations\n * Body mass index 18.0 to 32.0 kg/m2\n * Weight â‰¥ 50 kg\n\n","\n\n * Any medical condition that presents a potential risk to the subject and/or may compromise the objectives of the study, including a history of or active liver disease\n * History or presence of acute or chronic bacterial, fungal, or viral infection (eg, pneumonia, septicemia) within the 3 months prior to screening\n * Known or suspected autoimmune disorder, or any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the participant's immune status\n * History of administration of live vaccines within 60 days before screening\n * Any history or risk for tuberculosis (TB)\n\nOther protocol defined inclusion/exclusion criteria could apply",{"$nulls":4},"Actual","2018-02-05","Actual","Anticipated","2018-04-11","Anticipated","2018-03-01","2018-01-29","2018-01-29","2018-03-27","No",null,"Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","18 Years","50 Years","Male",null,"Yes",null,null,"URL: http://bms.com/studyconnect/Pages/home.aspx [http://bms.com/studyconnect/Pages/home.aspx] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: BMS Clinical Trial Patient Recruiting",null,"Yes","No",{"$nulls":19},"Maximum concentration (Cmax)|Area under the concentration vs time curve from time zero to 24 hours post dose (AUC[0-24])","24 hours",null,"Adverse events (AEs)","Up to 20 days",null,"Clinical.Trials@bms.com","Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,","please email:","Salt Lake City, Utah, United States, 84107","Utah","United States","Pra Health Sciences",null,"First line of the email MUST contain NCT # and Site #.",null,"Bristol-Myers Squibb","2018-03-27","2020-05-25T16:40:10.379","2020-05-26T17:10:42.972","NCT03419910"]
["5ecbf4ea11702c1b1b916c19","NCT03419910","2018-05-08","Bristol-Myers Squibb","BMY","Recruiting","An Investigational Study of Cyclosporine on Experimental Medication BMS-986165 in Healthy Male Participants","Bms-986165|Cyclosporin a","TYK2 Inhibitor|Calcineurin Inhibitor|Immunosuppressive","Yes","['Bms-986165']","Yes","['TYK2 Inhibitor']","Phase 1",1,20,"Anticipated","2018-03-05","2018-05-16","AUC","Area Under The Curve",{"$nulls":3},"This is an investigational study of Cyclosporine on the experimental medication BMS-986165 in healthy male participants.",null,"An Open-Label, Single-Sequence Study to Investigate the Effects of Cyclosporine on the Pharmacokinetics of BMS-986165 at Steady State in Healthy Male Participants","IM011-045","Psoriasis","Psoriasis","Dermatological Diseases","Derm & Connective Tissue Disorders","Experimental","BMS-986165 and cyclosporine","BMS-986165 and cyclosporine administered orally","Drug","BMS-986165|Cyclosporine","Specified dose on specified days",null,"BMS-986165 and cyclosporine","\n\n * Healthy participant, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations\n * Body mass index 18.0 to 32.0 kg/m2\n * Weight â‰¥ 50 kg\n\n","\n\n * Any medical condition that presents a potential risk to the subject and/or may compromise the objectives of the study, including a history of or active liver disease\n * History or presence of acute or chronic bacterial, fungal, or viral infection (eg, pneumonia, septicemia) within the 3 months prior to screening\n * Known or suspected autoimmune disorder, or any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the participant's immune status\n * History of administration of live vaccines within 60 days before screening\n * Any history or risk for tuberculosis (TB)\n\nOther protocol defined inclusion/exclusion criteria could apply",{"$nulls":4},"Actual","2018-02-05","Actual","Anticipated","2018-05-16","Anticipated","2018-05-01","2018-01-29","2018-01-29","2018-05-07","No",null,"Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","18 Years","50 Years","Male",null,"Yes",null,null,"URL: http://bms.com/studyconnect/Pages/home.aspx [http://bms.com/studyconnect/Pages/home.aspx] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: BMS Clinical Trial Patient Recruiting",null,"Yes","No",{"$nulls":19},"Maximum concentration (Cmax)|Area under the concentration vs time curve from time zero to 24 hours post dose (AUC[0-24])","24 hours",null,"Adverse events (AEs)","Up to 20 days",null,"Clinical.Trials@bms.com","Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,","please email:","Salt Lake City, Utah, United States, 84107","Utah","United States","Pra Health Sciences",null,"First line of the email MUST contain NCT # and Site #.",null,"Bristol-Myers Squibb","2018-05-07","2020-05-25T16:40:10.386","2020-05-26T17:10:42.972","NCT03419910"]
["5ecbf4eafeab101b15530a3d","NCT03419910","2018-05-29","Bristol-Myers Squibb","BMY","Completed","An Investigational Study of Cyclosporine on Experimental Medication BMS-986165 in Healthy Male Participants","Bms-986165|Cyclosporin a","TYK2 Inhibitor|Calcineurin Inhibitor|Immunosuppressive","Yes","['Bms-986165']","Yes","['TYK2 Inhibitor']","Phase 1",1,54,"Actual","2018-03-05","2018-05-04","AUC","Area Under The Curve",{"$nulls":3},"This is an investigational study of Cyclosporine on the experimental medication BMS-986165 in healthy male participants.",null,"An Open-Label, Single-Sequence Study to Investigate the Effects of Cyclosporine on the Pharmacokinetics of BMS-986165 at Steady State in Healthy Male Participants","IM011-045","Psoriasis","Psoriasis","Dermatological Diseases","Derm & Connective Tissue Disorders","Experimental","BMS-986165 and cyclosporine","BMS-986165 and cyclosporine administered orally","Drug","BMS-986165|Cyclosporine","Specified dose on specified days",null,"BMS-986165 and cyclosporine","\n\n * Healthy participant, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations\n * Body mass index 18.0 to 32.0 kg/m2\n * Weight â‰¥ 50 kg\n\n","\n\n * Any medical condition that presents a potential risk to the subject and/or may compromise the objectives of the study, including a history of or active liver disease\n * History or presence of acute or chronic bacterial, fungal, or viral infection (eg, pneumonia, septicemia) within the 3 months prior to screening\n * Known or suspected autoimmune disorder, or any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the participant's immune status\n * History of administration of live vaccines within 60 days before screening\n * Any history or risk for tuberculosis (TB)\n\nOther protocol defined inclusion/exclusion criteria could apply",{"$nulls":4},"Actual","2018-02-05","Actual","Actual","2018-05-04","Actual","2018-05-01","2018-01-29","2018-01-29","2018-05-25","No",null,"Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","18 Years","50 Years","Male",null,"Yes",null,null,"URL: http://bms.com/studyconnect/Pages/home.aspx [http://bms.com/studyconnect/Pages/home.aspx] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: BMS Clinical Trial Patient Recruiting",null,"Yes","No",{"$nulls":19},"Maximum concentration (Cmax)|Area under the concentration vs time curve from time zero to 24 hours post dose (AUC[0-24])","24 hours",null,"Adverse events (AEs)","Up to 20 days",{"$nulls":4},"Salt Lake City, Utah, United States, 84107","Utah","United States","Pra Health Sciences",{"$nulls":3},"Bristol-Myers Squibb","2018-05-25","2020-05-25T16:40:10.728","2020-05-26T17:10:42.972","NCT03419910"]
["5ecbf4eb307e3d1b1f8d9ea0","NCT03419910","2018-08-01","Bristol-Myers Squibb","BMY","Completed","An Investigational Study of Cyclosporine on Experimental Medication BMS-986165 in Healthy Male Participants","Bms-986165|Cyclosporin a","TYK2 Inhibitor|Calcineurin Inhibitor|Immunosuppressive","Yes","['Bms-986165']","Yes","['TYK2 Inhibitor']","Phase 1",1,54,"Actual","2018-03-05","2018-05-04","AUC","Area Under The Curve",{"$nulls":3},"This is an investigational study of Cyclosporine on the experimental medication BMS-986165 in healthy male participants.",null,"An Open-Label, Single-Sequence Study to Investigate the Effects of Cyclosporine on the Pharmacokinetics of BMS-986165 at Steady State in Healthy Male Participants","IM011-045","Psoriasis","Psoriasis","Dermatological Diseases","Derm & Connective Tissue Disorders","Experimental","BMS-986165 and cyclosporine","BMS-986165 and cyclosporine administered orally","Drug","BMS-986165|Cyclosporine","Specified dose on specified days",null,"BMS-986165 and cyclosporine","\n\n * Healthy participant, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations\n * Body mass index 18.0 to 32.0 kg/m2\n * Weight â‰¥ 50 kg\n\n","\n\n * Any medical condition that presents a potential risk to the subject and/or may compromise the objectives of the study, including a history of or active liver disease\n * History or presence of acute or chronic bacterial, fungal, or viral infection (eg, pneumonia, septicemia) within the 3 months prior to screening\n * Known or suspected autoimmune disorder, or any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the participant's immune status\n * History of administration of live vaccines within 60 days before screening\n * Any history or risk for tuberculosis (TB)\n\nOther protocol defined inclusion/exclusion criteria could apply",{"$nulls":4},"Actual","2018-02-05","Actual","Actual","2018-05-04","Actual","2018-07-01","2018-01-29","2018-01-29","2018-07-30","No",null,"Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","18 Years","50 Years","Male",null,"Yes",null,null,"URL: http://bms.com/studyconnect/Pages/home.aspx [http://bms.com/studyconnect/Pages/home.aspx] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: BMS Clinical Trial Patient Recruiting",null,"Yes","No",{"$nulls":19},"Maximum concentration (Cmax)|Area under the concentration vs time curve from time zero to 24 hours post dose (AUC[0-24])","24 hours",null,"Adverse events (AEs)","Up to 20 days",{"$nulls":4},"Salt Lake City, Utah, United States, 84107","Utah","United States","Pra Health Sciences",{"$nulls":3},"Bristol-Myers Squibb","2018-07-30","2020-05-25T16:40:11.137","2020-05-26T17:10:42.972","NCT03419910"]
["5ecbf4eae2561b1b11905f08","NCT03419910","2020-03-18","Bristol-Myers Squibb","BMY","Completed","An Investigational Study of Cyclosporine on Experimental Medication BMS-986165 in Healthy Male Participants","Bms-986165|Cyclosporin a","TYK2 Inhibitor|Calcineurin Inhibitor|Immunosuppressive","Yes","['Bms-986165']","Yes","['TYK2 Inhibitor']","Phase 1",1,54,"Actual","2018-03-05","2018-05-04","AUC","Area Under The Curve",{"$nulls":3},"This is an investigational study of Cyclosporine on the experimental medication BMS-986165 in healthy male participants.",null,"An Open-Label, Single-Sequence Study to Investigate the Effects of Cyclosporine on the Pharmacokinetics of BMS-986165 at Steady State in Healthy Male Participants","IM011-045","Psoriasis","Psoriasis","Dermatological Diseases","Derm & Connective Tissue Disorders","Experimental","BMS-986165 and cyclosporine","BMS-986165 and cyclosporine administered orally","Drug","BMS-986165|Cyclosporine","Specified dose on specified days",null,"BMS-986165 and cyclosporine","\n\n * Healthy participant, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations\n * Body mass index 18.0 to 32.0 kg/m2\n * Weight â‰¥ 50 kg\n\n","\n\n * Any medical condition that presents a potential risk to the subject and/or may compromise the objectives of the study, including a history of or active liver disease\n * History or presence of acute or chronic bacterial, fungal, or viral infection (eg, pneumonia, septicemia) within the 3 months prior to screening\n * Known or suspected autoimmune disorder, or any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the participant's immune status\n * History of administration of live vaccines within 60 days before screening\n * Any history or risk for tuberculosis (TB)\n\nOther protocol defined inclusion/exclusion criteria could apply",{"$nulls":4},"Actual","2018-02-05","Actual","Actual","2018-05-04","Actual","2020-03-01","2018-01-29","2018-01-29","2020-03-17","No",null,"Interventional","Treatment","Single Group Assignment","None (Open Label)","N/A","18 Years","50 Years","Male",null,"Yes",null,null,"URL: http://bms.com/studyconnect/Pages/home.aspx [http://bms.com/studyconnect/Pages/home.aspx] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: BMS Clinical Trial Patient Recruiting",null,"Yes","No",{"$nulls":19},"Maximum concentration (Cmax)|Area under the concentration vs time curve from time zero to 24 hours post dose (AUC[0-24])","24 hours",null,"Adverse events (AEs)","Up to 20 days",{"$nulls":4},"Salt Lake City, Utah, United States, 84124","Utah","United States","Pra Health Sciences",{"$nulls":3},"Bristol-Myers Squibb","2020-03-17","2020-05-25T16:40:10.666","2020-05-26T17:10:42.972","NCT03419910"]
["5ecbf4eee2561b1b11905f11","NCT03420222","2018-02-05","Avanir","AVNR","Recruiting","Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Intermittent Explosive Disorder","Avp-786",null,"Yes","['Avp-786']","Unknown",null,"Phase 2",2,150,"Anticipated","2018-01-01","2020-09-01",{"$nulls":5},"This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate AVP-786 for the treatment of Intermittent Explosive Disorder (IED).","Eligible participants for this study must have a diagnosis of current IED.\n\nThis is a multicenter, randomized, double-blind, placebo-controlled study, consisting of up to 12 weeks of treatment.","A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Intermittent Explosive Disorder (IED)","17-AVP-786-206","Intermittent Explosive Disorder","Tic Disorders","Neurodevelopmental Disorders","Central Nervous System","Experimental|Placebo Comparator","AVP-786|Placebo","Dose 1 capsules administered twice a day over a 12-week period|Placebo capsules administered twice a day over a 12-week period","Drug","AVP-786|Placebo","oral capsules",null,"AVP-786|Placebo","\n\n * Diagnosis of current Intermittent Explosive Disorder (IED) according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria, as solicited by the Structured Clinical Interview for DSM-5, Clinical Trials Version (SCID-5-CT)\n * At least 3 IED days (at least 1 IED episode each day, as recorded by the participant using the IED Daily Diary) per week for the 2 consecutive weeks directly preceding baseline with 70% compliance during that time frame, as assessed by the investigator\n * Score â‰¥ 12 on the Life History of Aggression scale at screening\n * Score â‰¥ 6 on the Overt Aggression Scale - Modified (OAS-M) Total Irritability at screening and baseline\n * Score â‰¥ 4 on the modified Clinical Global Impression of Severity (mCGI-S) for IED at screening and baseline\n\n","\n\n * Diagnosis of major depressive disorder within 6 months of screening\n * Significant symptoms of a depressive disorder or a Patient Health Questionnaire-9 (PHQ-9) score â‰¥ 10 at screening\n * Met only the DSM-5 A2 criterion for IED\n * Lifetime history of schizophrenia, schizoaffective disorder, bipolar disorder, antisocial personality disorder, neurocognitive disorder, or mental retardation (DSM-5 criteria)\n * Recurrent IED episodes that are better explained by another mental disorder or attributable to another medical condition (e.g., head trauma, Alzheimer's disease) or to the physiological effect of a substance (e.g., a drug of abuse, a medication) (DSM-5 criteria)",{"$nulls":4},"Actual","2018-02-05","Actual","Anticipated","2020-09-01","Anticipated","2018-01-01","2018-01-19","2018-01-28","2018-01-28","Yes","Intermittent Explosive Disorder\nAVP-786","Interventional","Treatment","Parallel Assignment","Triple (Participant, Investigator, Outcomes Assessor)","Randomized","18 Years","65 Years","All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":19},"Change from Baseline to Week 12 in the Overt Aggression Scale - Modified for Outpatient Use (OAS-M) Total Aggression Score","Baseline; Week 12",null,"Change from Baseline to Week 12 in the OAS-M Total Irritability Score|Change from Baseline to Week 12 in the OAS-M Individual Items for Aggression and Irritability|Change from Baseline to Week 12 in the Number of Intermittent Explosive Disorder (IED) Days|Change from Baseline to Week 12 in the Frequency and Severity of IED Episodes from the IED Diary|Change from Baseline to Week 12 in the OAS-M: Number of Discrete IED Episodes|Change from Baseline to Week 12 in the Modified Clinical Global Impression of Severity (mCGI-S) Score for IED|Change from Baseline to Week 12 in the Modified Clinical Global Impression of Change (mCGI-C) Score for IED|Change from Baseline to Week 12 in the Modified Patient Global Impression of Severity (mPGI-S) Score for IED|Change from Baseline to Week 12 in the Modified Patient Global Impression of Change (mPGI-C) Score for IED|Change from Baseline to Week 12 in the Sheehan Disability Scale (SDS) Score|Change from Baseline to Week 12 in the Short-Form 12-Item Health Survey (SF-12) Score|Change from Baseline to Week 12 in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score","Baseline; Week 12",{"$nulls":4},"Gainesville, Florida, United States, 32607|Atlanta, Georgia, United States, 30331|Chicago, Illinois, United States, 60637 University Of Chicago Medical Center Clinical Trial Site 2Chicago, Illinois, United States, 60637|New Bedford, Massachusetts, United States, 01740|O'Fallon, Missouri, United States, 63368|Las Vegas, Nevada, United States, 89102|Bronx, New York, United States, 10467 Manhattan Behavioral MedicineNew York, New York, United States, 10036|Mason, Ohio, United States, 45040","Florida|Georgia|Illinois|Massachusetts|Missouri|Nevada|New York|Ohio","United States","Sarkis Clinical Trials|Atlanta Center For Medical Research|University Of Chicago Medical Center Clinical Trial Site 1|Btc Of New Bedford|Psychiatric Care And Research Center|Atlea Research Institute|Montefiore Medical Center|Research Institute Lindner Center Of Hope/University Of Cincinnati",{"$nulls":4},"2018-01-28","2020-05-25T16:40:14.305","2020-05-26T17:10:42.972","NCT03420222"]
["5ecbf4ee307e3d1b1f8d9ea8","NCT03420222","2018-03-14","Avanir","AVNR","Recruiting","Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Intermittent Explosive Disorder","Avp-786",null,"Yes","['Avp-786']","Unknown",null,"Phase 2",2,150,"Anticipated","2018-01-01","2020-09-01",{"$nulls":5},"This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate AVP-786 for the treatment of Intermittent Explosive Disorder (IED).","Eligible participants for this study must have a diagnosis of current IED.\n\nThis is a multicenter, randomized, double-blind, placebo-controlled study, consisting of up to 12 weeks of treatment.","A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Intermittent Explosive Disorder (IED)","17-AVP-786-206","Intermittent Explosive Disorder","Tic Disorders","Neurodevelopmental Disorders","Central Nervous System","Experimental|Placebo Comparator","AVP-786|Placebo","Dose 1 capsules administered twice a day over a 12-week period|Placebo capsules administered twice a day over a 12-week period","Drug","AVP-786|Placebo","oral capsules",null,"AVP-786|Placebo","\n\n * Diagnosis of current Intermittent Explosive Disorder (IED) according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria, as solicited by the Structured Clinical Interview for DSM-5, Clinical Trials Version (SCID-5-CT)\n * At least 3 IED days (at least 1 IED episode each day, as recorded by the participant using the IED Daily Diary) per week for the 2 consecutive weeks directly preceding baseline with 70% compliance during that time frame, as assessed by the investigator\n * Score â‰¥ 12 on the Life History of Aggression scale at screening\n * Score â‰¥ 6 on the Overt Aggression Scale - Modified (OAS-M) Total Irritability at screening and baseline\n * Score â‰¥ 4 on the modified Clinical Global Impression of Severity (mCGI-S) for IED at screening and baseline\n\n","\n\n * Diagnosis of major depressive disorder within 6 months of screening\n * Significant symptoms of a depressive disorder or a Patient Health Questionnaire-9 (PHQ-9) score â‰¥ 10 at screening\n * Met only the DSM-5 A2 criterion for IED\n * Lifetime history of schizophrenia, schizoaffective disorder, bipolar disorder, antisocial personality disorder, neurocognitive disorder, or mental retardation (DSM-5 criteria)\n * Recurrent IED episodes that are better explained by another mental disorder or attributable to another medical condition (e.g., head trauma, Alzheimer's disease) or to the physiological effect of a substance (e.g., a drug of abuse, a medication) (DSM-5 criteria)",{"$nulls":4},"Actual","2018-02-05","Actual","Anticipated","2020-09-01","Anticipated","2018-03-01","2018-01-19","2018-01-28","2018-03-12","Yes","Intermittent Explosive Disorder\nAVP-786","Interventional","Treatment","Parallel Assignment","Triple (Participant, Investigator, Outcomes Assessor)","Randomized","18 Years","65 Years","All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":19},"Change from Baseline to Week 12 in the Overt Aggression Scale - Modified for Outpatient Use (OAS-M) Total Aggression Score","Baseline; Week 12",null,"Change from Baseline to Week 12 in the OAS-M Total Irritability Score|Change from Baseline to Week 12 in the OAS-M Individual Items for Aggression and Irritability|Change from Baseline to Week 12 in the Number of Intermittent Explosive Disorder (IED) Days|Change from Baseline to Week 12 in the Frequency and Severity of IED Episodes from the IED Diary|Change from Baseline to Week 12 in the OAS-M: Number of Discrete IED Episodes|Change from Baseline to Week 12 in the Modified Clinical Global Impression of Severity (mCGI-S) Score for IED|Change from Baseline to Week 12 in the Modified Clinical Global Impression of Change (mCGI-C) Score for IED|Change from Baseline to Week 12 in the Modified Patient Global Impression of Severity (mPGI-S) Score for IED|Change from Baseline to Week 12 in the Modified Patient Global Impression of Change (mPGI-C) Score for IED|Change from Baseline to Week 12 in the Sheehan Disability Scale (SDS) Score|Change from Baseline to Week 12 in the Short-Form 12-Item Health Survey (SF-12) Score|Change from Baseline to Week 12 in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score","Baseline; Week 12",{"$nulls":4},"Gainesville, Florida, United States, 32607|Atlanta, Georgia, United States, 30331|Chicago, Illinois, United States, 60637 University Of Chicago Medical Center Clinical Trial Site 2Chicago, Illinois, United States, 60637|New Bedford, Massachusetts, United States, 01740|O'Fallon, Missouri, United States, 63368|Las Vegas, Nevada, United States, 89102|Bronx, New York, United States, 10467 Manhattan Behavioral MedicineNew York, New York, United States, 10036|Mason, Ohio, United States, 45040","Florida|Georgia|Illinois|Massachusetts|Missouri|Nevada|New York|Ohio","United States","Sarkis Clinical Trials|Atlanta Center For Medical Research|University Of Chicago Medical Center Clinical Trial Site 1|Btc Of New Bedford|Psychiatric Care And Research Center|Atlea Research Institute|Montefiore Medical Center|Research Institute Lindner Center Of Hope/University Of Cincinnati",{"$nulls":4},"2018-03-12","2020-05-25T16:40:14.545","2020-05-26T17:10:42.972","NCT03420222"]
["5ecbf4eefe30261b1a048417","NCT03420222","2018-05-01","Avanir","AVNR","Recruiting","Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Intermittent Explosive Disorder","Avp-786",null,"Yes","['Avp-786']","Unknown",null,"Phase 2",2,150,"Anticipated","2018-01-01","2020-09-01",{"$nulls":5},"This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate AVP-786 for the treatment of Intermittent Explosive Disorder (IED).","Eligible participants for this study must have a diagnosis of current IED.\n\nThis is a multicenter, randomized, double-blind, placebo-controlled study, consisting of up to 12 weeks of treatment.","A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Intermittent Explosive Disorder (IED)","17-AVP-786-206","Intermittent Explosive Disorder","Tic Disorders","Neurodevelopmental Disorders","Central Nervous System","Experimental|Placebo Comparator","AVP-786|Placebo","Dose 1 capsules administered twice a day over a 12-week period|Placebo capsules administered twice a day over a 12-week period","Drug","AVP-786|Placebo","oral capsules",null,"AVP-786|Placebo","\n\n * Diagnosis of current Intermittent Explosive Disorder (IED) according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria, as solicited by the Structured Clinical Interview for DSM-5, Clinical Trials Version (SCID-5-CT)\n * At least 3 IED days (at least 1 IED episode each day, as recorded by the participant using the IED Daily Diary) per week for the 2 consecutive weeks directly preceding baseline with 70% compliance during that time frame, as assessed by the investigator\n * Score â‰¥ 12 on the Life History of Aggression scale at screening\n * Score â‰¥ 6 on the Overt Aggression Scale - Modified (OAS-M) Total Irritability at screening and baseline\n * Score â‰¥ 4 on the modified Clinical Global Impression of Severity (mCGI-S) for IED at screening and baseline\n\n","\n\n * Diagnosis of major depressive disorder within 6 months of screening\n * Significant symptoms of a depressive disorder or a Patient Health Questionnaire-9 (PHQ-9) score â‰¥ 10 at screening\n * Met only the DSM-5 A2 criterion for IED\n * Lifetime history of schizophrenia, schizoaffective disorder, bipolar disorder, antisocial personality disorder, neurocognitive disorder, or mental retardation (DSM-5 criteria)\n * Recurrent IED episodes that are better explained by another mental disorder or attributable to another medical condition (e.g., head trauma, Alzheimer's disease) or to the physiological effect of a substance (e.g., a drug of abuse, a medication) (DSM-5 criteria)",{"$nulls":4},"Actual","2018-02-05","Actual","Anticipated","2020-09-01","Anticipated","2018-04-01","2018-01-19","2018-01-28","2018-04-30","Yes","Intermittent Explosive Disorder\nAVP-786","Interventional","Treatment","Parallel Assignment","Triple (Participant, Investigator, Outcomes Assessor)","Randomized","18 Years","65 Years","All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":19},"Change from Baseline to Week 12 in the Overt Aggression Scale - Modified for Outpatient Use (OAS-M) Total Aggression Score","Baseline; Week 12",null,"Change from Baseline to Week 12 in the OAS-M Total Irritability Score|Change from Baseline to Week 12 in the OAS-M Individual Items for Aggression and Irritability|Change from Baseline to Week 12 in the Number of Intermittent Explosive Disorder (IED) Days|Change from Baseline to Week 12 in the Frequency and Severity of IED Episodes from the IED Diary|Change from Baseline to Week 12 in the OAS-M: Number of Discrete IED Episodes|Change from Baseline to Week 12 in the Modified Clinical Global Impression of Severity (mCGI-S) Score for IED|Change from Baseline to Week 12 in the Modified Clinical Global Impression of Change (mCGI-C) Score for IED|Change from Baseline to Week 12 in the Modified Patient Global Impression of Severity (mPGI-S) Score for IED|Change from Baseline to Week 12 in the Modified Patient Global Impression of Change (mPGI-C) Score for IED|Change from Baseline to Week 12 in the Sheehan Disability Scale (SDS) Score|Change from Baseline to Week 12 in the Short-Form 12-Item Health Survey (SF-12) Score|Change from Baseline to Week 12 in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score","Baseline; Week 12",{"$nulls":4},"Gainesville, Florida, United States, 32607|Atlanta, Georgia, United States, 30331|Chicago, Illinois, United States, 60637 University Of Chicago Medical Center Clinical Trial Site 2Chicago, Illinois, United States, 60637|New Bedford, Massachusetts, United States, 01740|O'Fallon, Missouri, United States, 63368|Las Vegas, Nevada, United States, 89102|Bronx, New York, United States, 10467 Manhattan Behavioral MedicineNew York, New York, United States, 10036|Mason, Ohio, United States, 45040","Florida|Georgia|Illinois|Massachusetts|Missouri|Nevada|New York|Ohio","United States","Sarkis Clinical Trials|Atlanta Center For Medical Research|University Of Chicago Medical Center Clinical Trial Site 1|Btc Of New Bedford|Psychiatric Care And Research Center|Atlea Research Institute|Montefiore Medical Center|Research Institute Lindner Center Of Hope/University Of Cincinnati",{"$nulls":4},"2018-04-30","2020-05-25T16:40:14.538","2020-05-26T17:10:42.972","NCT03420222"]
["5ecbf4eefeab101b15530a46","NCT03420222","2018-05-24","Avanir","AVNR","Recruiting","Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Intermittent Explosive Disorder","Avp-786",null,"Yes","['Avp-786']","Unknown",null,"Phase 2",2,150,"Anticipated","2018-01-01","2020-09-01",{"$nulls":5},"This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate AVP-786 for the treatment of Intermittent Explosive Disorder (IED).","Eligible participants for this study must have a diagnosis of current IED.\n\nThis is a multicenter, randomized, double-blind, placebo-controlled study, consisting of up to 12 weeks of treatment.","A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Intermittent Explosive Disorder (IED)","17-AVP-786-206","Intermittent Explosive Disorder","Tic Disorders","Neurodevelopmental Disorders","Central Nervous System","Experimental|Placebo Comparator","AVP-786|Placebo","Dose 1 capsules administered twice a day over a 12-week period|Placebo capsules administered twice a day over a 12-week period","Drug","AVP-786|Placebo","oral capsules",null,"AVP-786|Placebo","\n\n * Diagnosis of current Intermittent Explosive Disorder (IED) according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria, as solicited by the Structured Clinical Interview for DSM-5, Clinical Trials Version (SCID-5-CT)\n * At least 3 IED days (at least 1 IED episode each day, as recorded by the participant using the IED Daily Diary) per week for the 2 consecutive weeks directly preceding baseline with 70% compliance during that time frame, as assessed by the investigator\n * Score â‰¥ 12 on the Life History of Aggression scale at screening\n * Score â‰¥ 6 on the Overt Aggression Scale - Modified (OAS-M) Total Irritability at screening and baseline\n * Score â‰¥ 4 on the modified Clinical Global Impression of Severity (mCGI-S) for IED at screening and baseline\n\n","\n\n * Diagnosis of major depressive disorder within 6 months of screening\n * Significant symptoms of a depressive disorder or a Patient Health Questionnaire-9 (PHQ-9) score â‰¥ 10 at screening\n * Met only the DSM-5 A2 criterion for IED\n * Lifetime history of schizophrenia, schizoaffective disorder, bipolar disorder, antisocial personality disorder, neurocognitive disorder, or mental retardation (DSM-5 criteria)\n * Recurrent IED episodes that are better explained by another mental disorder or attributable to another medical condition (e.g., head trauma, Alzheimer's disease) or to the physiological effect of a substance (e.g., a drug of abuse, a medication) (DSM-5 criteria)",{"$nulls":4},"Actual","2018-02-05","Actual","Anticipated","2020-09-01","Anticipated","2018-05-01","2018-01-19","2018-01-28","2018-05-23","Yes","Intermittent Explosive Disorder\nAVP-786","Interventional","Treatment","Parallel Assignment","Triple (Participant, Investigator, Outcomes Assessor)","Randomized","18 Years","65 Years","All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":19},"Change from Baseline to Week 12 in the Overt Aggression Scale - Modified for Outpatient Use (OAS-M) Total Aggression Score","Baseline; Week 12",null,"Change from Baseline to Week 12 in the OAS-M Total Irritability Score|Change from Baseline to Week 12 in the OAS-M Individual Items for Aggression and Irritability|Change from Baseline to Week 12 in the Number of Intermittent Explosive Disorder (IED) Days|Change from Baseline to Week 12 in the Frequency and Severity of IED Episodes from the IED Diary|Change from Baseline to Week 12 in the OAS-M: Number of Discrete IED Episodes|Change from Baseline to Week 12 in the Modified Clinical Global Impression of Severity (mCGI-S) Score for IED|Change from Baseline to Week 12 in the Modified Clinical Global Impression of Change (mCGI-C) Score for IED|Change from Baseline to Week 12 in the Modified Patient Global Impression of Severity (mPGI-S) Score for IED|Change from Baseline to Week 12 in the Modified Patient Global Impression of Change (mPGI-C) Score for IED|Change from Baseline to Week 12 in the Sheehan Disability Scale (SDS) Score|Change from Baseline to Week 12 in the Short-Form 12-Item Health Survey (SF-12) Score|Change from Baseline to Week 12 in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score","Baseline; Week 12",{"$nulls":4},"Gainesville, Florida, United States, 32607|Atlanta, Georgia, United States, 30331|Chicago, Illinois, United States, 60637 University Of Chicago Medical Center Clinical Trial Site 2Chicago, Illinois, United States, 60637|New Bedford, Massachusetts, United States, 01740|O'Fallon, Missouri, United States, 63368 Advanced Clinical Research CenterSaint Louis, Missouri, United States, 63123|Las Vegas, Nevada, United States, 89102|Bronx, New York, United States, 10467 Intergrative Clinical TrialsBrooklyn, New York, United States, 11229 Manhattan Behavioral MedicineNew York, New York, United States, 10036|Mason, Ohio, United States, 45040","Florida|Georgia|Illinois|Massachusetts|Missouri|Nevada|New York|Ohio","United States","Sarkis Clinical Trials|Atlanta Center For Medical Research|University Of Chicago Medical Center Clinical Trial Site 1|Btc Of New Bedford|Psychiatric Care And Research Center|Atlea Research Institute|Montefiore Medical Center|Research Institute Lindner Center Of Hope/University Of Cincinnati",{"$nulls":4},"2018-05-23","2020-05-25T16:40:14.310","2020-05-26T17:10:42.972","NCT03420222"]
["5ecbf4eee2561b1b11905f12","NCT03420222","2018-10-31","Avanir","AVNR","Active, not recruiting","Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Intermittent Explosive Disorder","Avp-786",null,"Yes","['Avp-786']","Unknown",null,"Phase 2",2,10,"Actual","2018-01-01","2020-09-01",{"$nulls":5},"This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate AVP-786 for the treatment of Intermittent Explosive Disorder (IED).","Eligible participants for this study must have a diagnosis of current IED.\n\nThis is a multicenter, randomized, double-blind, placebo-controlled study, consisting of up to 12 weeks of treatment.","A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Intermittent Explosive Disorder (IED)","17-AVP-786-206","Intermittent Explosive Disorder","Tic Disorders","Neurodevelopmental Disorders","Central Nervous System","Experimental|Placebo Comparator","AVP-786|Placebo","Dose 1 capsules administered twice a day over a 12-week period|Placebo capsules administered twice a day over a 12-week period","Drug","AVP-786|Placebo","oral capsules",null,"AVP-786|Placebo","\n\n * Diagnosis of current Intermittent Explosive Disorder (IED) according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria, as solicited by the Structured Clinical Interview for DSM-5, Clinical Trials Version (SCID-5-CT)\n * At least 3 IED days (at least 1 IED episode each day, as recorded by the participant using the IED Daily Diary) per week for the 2 consecutive weeks directly preceding baseline with 70% compliance during that time frame, as assessed by the investigator\n * Score â‰¥ 12 on the Life History of Aggression scale at screening\n * Score â‰¥ 6 on the Overt Aggression Scale - Modified (OAS-M) Total Irritability at screening and baseline\n * Score â‰¥ 4 on the modified Clinical Global Impression of Severity (mCGI-S) for IED at screening and baseline\n\n","\n\n * Diagnosis of major depressive disorder within 6 months of screening\n * Significant symptoms of a depressive disorder or a Patient Health Questionnaire-9 (PHQ-9) score â‰¥ 10 at screening\n * Met only the DSM-5 A2 criterion for IED\n * Lifetime history of schizophrenia, schizoaffective disorder, bipolar disorder, antisocial personality disorder, neurocognitive disorder, or mental retardation (DSM-5 criteria)\n * Recurrent IED episodes that are better explained by another mental disorder or attributable to another medical condition (e.g., head trauma, Alzheimer's disease) or to the physiological effect of a substance (e.g., a drug of abuse, a medication) (DSM-5 criteria)",{"$nulls":4},"Actual","2018-02-05","Actual","Anticipated","2020-09-01","Anticipated","2018-10-01","2018-01-19","2018-01-28","2018-10-29","Yes","Intermittent Explosive Disorder\nAVP-786","Interventional","Treatment","Parallel Assignment","Triple (Participant, Investigator, Outcomes Assessor)","Randomized","18 Years","65 Years","All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":19},"Change from Baseline to Week 12 in the Overt Aggression Scale - Modified for Outpatient Use (OAS-M) Total Aggression Score","Baseline; Week 12",null,"Change from Baseline to Week 12 in the OAS-M Total Irritability Score|Change from Baseline to Week 12 in the OAS-M Individual Items for Aggression and Irritability|Change from Baseline to Week 12 in the Number of Intermittent Explosive Disorder (IED) Days|Change from Baseline to Week 12 in the Frequency and Severity of IED Episodes from the IED Diary|Change from Baseline to Week 12 in the OAS-M: Number of Discrete IED Episodes|Change from Baseline to Week 12 in the Modified Clinical Global Impression of Severity (mCGI-S) Score for IED|Change from Baseline to Week 12 in the Modified Clinical Global Impression of Change (mCGI-C) Score for IED|Change from Baseline to Week 12 in the Modified Patient Global Impression of Severity (mPGI-S) Score for IED|Change from Baseline to Week 12 in the Modified Patient Global Impression of Change (mPGI-C) Score for IED|Change from Baseline to Week 12 in the Sheehan Disability Scale (SDS) Score|Change from Baseline to Week 12 in the Short-Form 12-Item Health Survey (SF-12) Score|Change from Baseline to Week 12 in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score","Baseline; Week 12",{"$nulls":4},"Gainesville, Florida, United States, 32607|Atlanta, Georgia, United States, 30331|Chicago, Illinois, United States, 60637|New Bedford, Massachusetts, United States, 01740|O'Fallon, Missouri, United States, 63368|Las Vegas, Nevada, United States, 89102|Bronx, New York, United States, 10467 Intergrative Clinical TrialsBrooklyn, New York, United States, 11229 Manhattan Behavioral MedicineNew York, New York, United States, 10036|Mason, Ohio, United States, 45040","Florida|Georgia|Illinois|Massachusetts|Missouri|Nevada|New York|Ohio","United States","Sarkis Clinical Trials|Atlanta Center For Medical Research|University Of Chicago Medical Center Clinical Trial Site 2|Btc Of New Bedford|Psychiatric Care And Research Center|Atlea Research Institute|Montefiore Medical Center|Research Institute Lindner Center Of Hope/University Of Cincinnati",{"$nulls":4},"2018-10-29","2020-05-25T16:40:14.741","2020-05-26T17:10:42.972","NCT03420222"]
["5ecbf4ee307e3d1b1f8d9ea9","NCT03420222","2019-01-31","Avanir","AVNR","Terminated","Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Intermittent Explosive Disorder","Avp-786",null,"Yes","['Avp-786']","Unknown",null,"Phase 2",2,10,"Actual","2018-01-01","2018-12-28",{"$nulls":5},"This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate AVP-786 for the treatment of Intermittent Explosive Disorder (IED).","Eligible participants for this study must have a diagnosis of current IED.\n\nThis is a multicenter, randomized, double-blind, placebo-controlled study, consisting of up to 12 weeks of treatment.","A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Intermittent Explosive Disorder (IED)","17-AVP-786-206","Intermittent Explosive Disorder","Tic Disorders","Neurodevelopmental Disorders","Central Nervous System","Experimental|Placebo Comparator","AVP-786|Placebo","Dose 1 capsules administered twice a day over a 12-week period|Placebo capsules administered twice a day over a 12-week period","Drug","AVP-786|Placebo","oral capsules",null,"AVP-786|Placebo","\n\n * Diagnosis of current Intermittent Explosive Disorder (IED) according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria, as solicited by the Structured Clinical Interview for DSM-5, Clinical Trials Version (SCID-5-CT)\n * At least 3 IED days (at least 1 IED episode each day, as recorded by the participant using the IED Daily Diary) per week for the 2 consecutive weeks directly preceding baseline with 70% compliance during that time frame, as assessed by the investigator\n * Score â‰¥ 12 on the Life History of Aggression scale at screening\n * Score â‰¥ 6 on the Overt Aggression Scale - Modified (OAS-M) Total Irritability at screening and baseline\n * Score â‰¥ 4 on the modified Clinical Global Impression of Severity (mCGI-S) for IED at screening and baseline\n\n","\n\n * Diagnosis of major depressive disorder within 6 months of screening\n * Significant symptoms of a depressive disorder or a Patient Health Questionnaire-9 (PHQ-9) score â‰¥ 10 at screening\n * Met only the DSM-5 A2 criterion for IED\n * Lifetime history of schizophrenia, schizoaffective disorder, bipolar disorder, antisocial personality disorder, neurocognitive disorder, or mental retardation (DSM-5 criteria)\n * Recurrent IED episodes that are better explained by another mental disorder or attributable to another medical condition (e.g., head trauma, Alzheimer's disease) or to the physiological effect of a substance (e.g., a drug of abuse, a medication) (DSM-5 criteria)",{"$nulls":4},"Actual","2018-02-05","Actual","Actual","2018-12-28","Actual","2019-01-01","2018-01-19","2018-01-28","2019-01-29","Yes","Intermittent Explosive Disorder\nAVP-786","Interventional","Treatment","Parallel Assignment","Triple (Participant, Investigator, Outcomes Assessor)","Randomized","18 Years","65 Years","All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":19},"Change from Baseline to Week 12 in the Overt Aggression Scale - Modified for Outpatient Use (OAS-M) Total Aggression Score","Baseline; Week 12",null,"Change from Baseline to Week 12 in the OAS-M Total Irritability Score|Change from Baseline to Week 12 in the OAS-M Individual Items for Aggression and Irritability|Change from Baseline to Week 12 in the Number of Intermittent Explosive Disorder (IED) Days|Change from Baseline to Week 12 in the Frequency and Severity of IED Episodes from the IED Diary|Change from Baseline to Week 12 in the OAS-M: Number of Discrete IED Episodes|Change from Baseline to Week 12 in the Modified Clinical Global Impression of Severity (mCGI-S) Score for IED|Change from Baseline to Week 12 in the Modified Clinical Global Impression of Change (mCGI-C) Score for IED|Change from Baseline to Week 12 in the Modified Patient Global Impression of Severity (mPGI-S) Score for IED|Change from Baseline to Week 12 in the Modified Patient Global Impression of Change (mPGI-C) Score for IED|Change from Baseline to Week 12 in the Sheehan Disability Scale (SDS) Score|Change from Baseline to Week 12 in the Short-Form 12-Item Health Survey (SF-12) Score|Change from Baseline to Week 12 in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score","Baseline; Week 12",{"$nulls":4},"Gainesville, Florida, United States, 32607|Atlanta, Georgia, United States, 30331|Chicago, Illinois, United States, 60637|New Bedford, Massachusetts, United States, 01740|O'Fallon, Missouri, United States, 63368|Las Vegas, Nevada, United States, 89102|Bronx, New York, United States, 10467 Intergrative Clinical TrialsBrooklyn, New York, United States, 11229 Manhattan Behavioral MedicineNew York, New York, United States, 10036|Mason, Ohio, United States, 45040","Florida|Georgia|Illinois|Massachusetts|Missouri|Nevada|New York|Ohio","United States","Sarkis Clinical Trials|Atlanta Center For Medical Research|University Of Chicago Medical Center Clinical Trial Site 2|Btc Of New Bedford|Psychiatric Care And Research Center|Atlea Research Institute|Montefiore Medical Center|Research Institute Lindner Center Of Hope/University Of Cincinnati",{"$nulls":4},"2019-01-29","2020-05-25T16:40:14.714","2020-05-26T17:10:42.972","NCT03420222"]
["5ecbf4eefeab101b15530a47","NCT03420222","2019-12-24","Avanir","AVNR","Terminated","Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Intermittent Explosive Disorder","Avp-786",null,"Yes","['Avp-786']","Unknown",null,"Phase 2",2,10,"Actual","2018-01-01","2018-12-28",{"$nulls":5},"This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate AVP-786 for the treatment of Intermittent Explosive Disorder (IED).","Eligible participants for this study must have a diagnosis of current IED.\n\nThis is a multicenter, randomized, double-blind, placebo-controlled study, consisting of up to 12 weeks of treatment.","A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Intermittent Explosive Disorder (IED)","17-AVP-786-206","Intermittent Explosive Disorder","Tic Disorders","Neurodevelopmental Disorders","Central Nervous System","Experimental|Placebo Comparator","AVP-786|Placebo","Dose 1 capsules administered twice a day over a 12-week period|Placebo capsules administered twice a day over a 12-week period","Drug","AVP-786|Placebo","oral capsules",null,"AVP-786|Placebo","\n\n * Diagnosis of current Intermittent Explosive Disorder (IED) according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria, as solicited by the Structured Clinical Interview for DSM-5, Clinical Trials Version (SCID-5-CT)\n * At least 3 IED days (at least 1 IED episode each day, as recorded by the participant using the IED Daily Diary) per week for the 2 consecutive weeks directly preceding baseline with 70% compliance during that time frame, as assessed by the investigator\n * Score â‰¥ 12 on the Life History of Aggression scale at screening\n * Score â‰¥ 6 on the Overt Aggression Scale - Modified (OAS-M) Total Irritability at screening and baseline\n * Score â‰¥ 4 on the modified Clinical Global Impression of Severity (mCGI-S) for IED at screening and baseline\n\n","\n\n * Diagnosis of major depressive disorder within 6 months of screening\n * Significant symptoms of a depressive disorder or a Patient Health Questionnaire-9 (PHQ-9) score â‰¥ 10 at screening\n * Met only the DSM-5 A2 criterion for IED\n * Lifetime history of schizophrenia, schizoaffective disorder, bipolar disorder, antisocial personality disorder, neurocognitive disorder, or mental retardation (DSM-5 criteria)\n * Recurrent IED episodes that are better explained by another mental disorder or attributable to another medical condition (e.g., head trauma, Alzheimer's disease) or to the physiological effect of a substance (e.g., a drug of abuse, a medication) (DSM-5 criteria)",{"$nulls":4},"Actual","2018-02-05","Actual","Actual","2018-12-28","Actual","2019-12-01","2018-01-19","2018-01-28","2019-12-20","Yes","Intermittent Explosive Disorder\nAVP-786","Interventional","Treatment","Parallel Assignment","Triple (Participant, Investigator, Outcomes Assessor)","Randomized","18 Years","65 Years","All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":7},43819,43819,"December 24, 2019 [Actual]",{"$nulls":9},"Change from Baseline to Week 12 in the Overt Aggression Scale - Modified for Outpatient Use (OAS-M) Total Aggression Score","Baseline; Week 12",null,"Change from Baseline to Week 12 in the OAS-M Total Irritability Score|Change from Baseline to Week 12 in the OAS-M Individual Items for Aggression and Irritability|Change from Baseline to Week 12 in the Number of Intermittent Explosive Disorder (IED) Days|Change from Baseline to Week 12 in the Frequency and Severity of IED Episodes from the IED Diary|Change from Baseline to Week 12 in the OAS-M: Number of Discrete IED Episodes|Change from Baseline to Week 12 in the Modified Clinical Global Impression of Severity (mCGI-S) Score for IED|Change from Baseline to Week 12 in the Modified Clinical Global Impression of Change (mCGI-C) Score for IED|Change from Baseline to Week 12 in the Modified Patient Global Impression of Severity (mPGI-S) Score for IED|Change from Baseline to Week 12 in the Modified Patient Global Impression of Change (mPGI-C) Score for IED|Change from Baseline to Week 12 in the Sheehan Disability Scale (SDS) Score|Change from Baseline to Week 12 in the Short-Form 12-Item Health Survey (SF-12) Score|Change from Baseline to Week 12 in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score","Baseline; Week 12",{"$nulls":4},"Gainesville, Florida, United States, 32607|Atlanta, Georgia, United States, 30331|Chicago, Illinois, United States, 60637|New Bedford, Massachusetts, United States, 01740|O'Fallon, Missouri, United States, 63368|Las Vegas, Nevada, United States, 89102|Bronx, New York, United States, 10467 Manhattan Behavioral MedicineNew York, New York, United States, 10036|Mason, Ohio, United States, 45040","Florida|Georgia|Illinois|Massachusetts|Missouri|Nevada|New York|Ohio","United States","Sarkis Clinical Trials|Atlanta Center For Medical Research|University Of Chicago Medical Center Clinical Trial Site 2|Btc Of New Bedford|Psychiatric Care And Research Center|Atlea Research Institute|Montefiore Medical Center|Research Institute Lindner Center Of Hope/University Of Cincinnati",{"$nulls":4},"2019-12-20","2020-05-25T16:40:14.828","2020-05-26T17:10:42.972","NCT03420222"]
["5ecbf4ef11702c1b1b916c25","NCT03420742","2018-02-05","Ariad","ARIA","Not yet recruiting","A Study Between Brigatinib and the Cytochrome P450 3A (CYP3A) Substrate Midazolam in Participants With Anaplastic Lymphoma Kinase (ALK) or C-Ros Oncogene 1 (ROS1) Positive Solid Tumors","Midazolam|Brigatinib","GABA Agonist|TK Inhibitor|ALK Inhibitor","Yes","['Midazolam']","No",null,"Phase 1",1,20,"Anticipated","2018-04-20","2019-06-15","AUC","Area Under The Curve",{"$nulls":3},"The purpose of this study is to characterize the effect of repeat-dose administration of brigatinib 180 milligram (mg) once daily (QD) on the single-dose pharmacokinetics (PK) of midazolam.","The study will enroll approximately 20 participants to achieve approximately 15 PK-evaluable participants for assessment. This study will consist of 2 parts: Part A of the study will evaluate the effect of repeat-dose administration of brigatinib on the single-dose PK of midazolam. Part B of the study is exploratory and will allow participants to continue brigatinib until disease progression (PD). All participants will receive study drug via the oral route. Participants will be assigned to: Midazolam 3 mg + Brigatinib 90 mg.\n\nThe overall time to participate in this study is 26 months. Participants will have a 28-day PK cycle in Part A and a maximum of 23 cycles in Part B, and a 30-day follow-up period after end of treatment.","A Phase 1 Drug-Drug Interaction Study Between Brigatinib and the CYP3A Substrate Midazolam in Patients With ALK-Positive or ROS1-Positive Solid Tumors","Brigatinib-1001","Carcinoma, Advanced ALK+ or ROS1+Non-Small-Cell Lung, Neoplasm, Advanced ALK+ or ROS1+Solid Tumors","Small Cell Lung Cancer|Noma|Carcinoma|Non-Small-Cell Lung Cancer|Small Cell Carcinoma","Oncology Solid Tumor|Mouth Diseases","Oncology|Ear, Nose and Throat","Experimental","Midazolam 3 mg + Brigatinib 90 mg","Midazolam 3 mg, orally, once on Day 1, followed by brigatinib 90 mg, orally, once daily on Days 2 to 8, further followed by brigatinib 180 mg, orally, once daily on Days 9 to 28 in Part A Cycle 1 (28 days treatment cycle). Participants escalating to brigatinib 180 mg once daily will also receive midazolam 3 mg, orally, once on Day 21 of Part A Cycle 1. After completion of Part A, participants will continue into Part B. Participants in Part B will receive brigatinib up to 180 mg (or at the highest tolerated dose in Part A), orally, once daily in a 28 day treatment cycle, up to a maximum of 23 cycles or until progression of disease, unacceptable toxicity, or another discontinuation criterion is met.","Drug","Midazolam|Brigatinib","Midazolam syrup.|Brigatinib tablets.","Alunbrig","Midazolam 3 mg + Brigatinib 90 mg","\n\n 1. Locally advanced or metastatic solid tumors who meet 1 of the following 4 criteria: * With locally advanced or metastatic ALK-positive NSCLC who have progressed on or are intolerant to treatment with at least 1 other ALK inhibitor.\n     * With ALK-positive nonlung solid tumors that are locally advanced or metastatic and for whom no standard, nonexperimental therapy is available.\n     * With locally advanced or metastatic ROS1-positive NSCLC who have progressed on crizotinib therapy or are intolerant to crizotinib, or\n     * With ROS1-positive nonlung solid tumors that are locally advanced or metastatic and for whom no standard, nonexperimental therapy is available.\n    \n    \n 2. Eastern cooperative Oncology Group (ECOG) performance status of 0 or 1.\n 3. Have at least 1 target lesion per response evaluation criteria in solid tumors (RECIST) version 1.1.\n 4. Have recovered from toxicities related to prior anticancer therapy to National Cancer Institute common terminology criteria for adverse events (NCI CTCAE) version 4.03 Grade less than or equal to (<=) 1.\n 5. Suitable venous access for study-required blood sampling (that is, including PK and laboratory safety tests).\n\n","\n\n 1. Systemic treatment with strong or moderate cytochrome P450 3A (CYP3A) inhibitors or inducers within 14 days before enrollment.\n 2. Prior therapy with brigatinib.\n 3. Received prior ALK-inhibitor therapy within 7 days before the first dose of study drug.\n 4. Treatment with any investigational systemic anticancer agents within 14 days or 5 half-lives, whichever is longer, before the first dose of study drug.\n 5. Received chemotherapy or radiation therapy within 14 days before the first dose of study drug, except for stereotactic radiosurgery (SRS) or stereotactic body radiation therapy.\n 6. Received antineoplastic monoclonal antibodies within 30 days before the first dose of study drug.\n 7. Had major surgery within 30 days before the first dose of study drug. Minor surgical procedures, such as catheter placement or minimally invasive biopsies, are allowed.\n 8. Have current spinal cord compression (symptomatic or asymptomatic and detected by radiographic imaging). Patients with leptomeningeal disease and without cord compression are allowed.",{"$nulls":4},"Actual","2018-02-05","Actual","Anticipated","2020-08-18","Anticipated","2018-01-01","2018-01-29","2018-01-29","2018-01-29","No","Drug therapy, brigatinib, lung cancer, ALK, ROS1","Interventional","Other","Sequential Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"U1111-1203-0166","WHO","Part A: AUCâˆž: Area Under the Plasma Concentration-Time Curve from Time 0 to Infinity (AUCâˆž) for Midazolam|Part A: Cmax: Maximum Observed Plasma Concentration for Midazolam|Part A: Tmax: Time to Reach the Maximum Observed Plasma Concentration (Cmax) for Midazolam","Days 1 and 21 pre-dose and at multiple time points (up to 24 hours) post-dose",{"$nulls":4},"GlobalOncologyMedinfo@takeda.com","Takeda Study Registration Call Center",{"$f":"1-844-662-8532","v":-10037},{"$nulls":7},"Medical Director","2018-01-29","2020-05-25T16:40:15.398","2020-05-26T17:10:42.972","NCT03420742"]
["5ecbf4effeab101b15530a48","NCT03420742","2018-05-04","Ariad","ARIA","Not yet recruiting","A Study Between Brigatinib and the Cytochrome P450 3A (CYP3A) Substrate Midazolam in Participants With Anaplastic Lymphoma Kinase (ALK) or C-Ros Oncogene 1 (ROS1) Positive Solid Tumors","Midazolam|Brigatinib","GABA Agonist|TK Inhibitor|ALK Inhibitor","Yes","['Midazolam']","No",null,"Phase 1",1,20,"Anticipated","2018-10-29","2019-06-15","AUC","Area Under The Curve",{"$nulls":3},"The purpose of this study is to characterize the effect of repeat-dose administration of brigatinib 180 milligram (mg) once daily (QD) on the single-dose pharmacokinetics (PK) of midazolam.","The study will enroll approximately 20 participants to achieve approximately 15 PK-evaluable participants for assessment. This study will consist of 2 parts: Part A of the study will evaluate the effect of repeat-dose administration of brigatinib on the single-dose PK of midazolam. Part B of the study is exploratory and will allow participants to continue brigatinib until disease progression (PD). All participants will receive study drug via the oral route. Participants will be assigned to: Midazolam 3 mg + Brigatinib 90 mg.\n\nThe overall time to participate in this study is 26 months. Participants will have a 28-day PK cycle in Part A and a maximum of 23 cycles in Part B, and a 30-day follow-up period after end of treatment.","A Phase 1 Drug-Drug Interaction Study Between Brigatinib and the CYP3A Substrate Midazolam in Patients With ALK-Positive or ROS1-Positive Solid Tumors","Brigatinib-1001","Carcinoma, Advanced ALK+ or ROS1+Non-Small-Cell Lung, Neoplasm, Advanced ALK+ or ROS1+Solid Tumors","Small Cell Lung Cancer|Noma|Carcinoma|Non-Small-Cell Lung Cancer|Small Cell Carcinoma","Oncology Solid Tumor|Mouth Diseases","Oncology|Ear, Nose and Throat","Experimental","Midazolam 3 mg + Brigatinib 90 mg","Midazolam 3 mg, orally, once on Day 1, followed by brigatinib 90 mg, orally, once daily on Days 2 to 8, further followed by brigatinib 180 mg, orally, once daily on Days 9 to 28 in Part A Cycle 1 (28 days treatment cycle). Participants escalating to brigatinib 180 mg once daily will also receive midazolam 3 mg, orally, once on Day 21 of Part A Cycle 1. After completion of Part A, participants will continue into Part B. Participants in Part B will receive brigatinib up to 180 mg (or at the highest tolerated dose in Part A), orally, once daily in a 28 day treatment cycle, up to a maximum of 23 cycles or until progression of disease, unacceptable toxicity, or another discontinuation criterion is met.","Drug","Midazolam|Brigatinib","Midazolam syrup.|Brigatinib tablets.","Alunbrig","Midazolam 3 mg + Brigatinib 90 mg","\n\n 1. Locally advanced or metastatic solid tumors who meet 1 of the following 4 criteria: * With locally advanced or metastatic ALK-positive NSCLC who have progressed on or are intolerant to treatment with at least 1 other ALK inhibitor.\n     * With ALK-positive nonlung solid tumors that are locally advanced or metastatic and for whom no standard, nonexperimental therapy is available.\n     * With locally advanced or metastatic ROS1-positive NSCLC who have progressed on crizotinib therapy or are intolerant to crizotinib, or\n     * With ROS1-positive nonlung solid tumors that are locally advanced or metastatic and for whom no standard, nonexperimental therapy is available.\n    \n    \n 2. Eastern cooperative Oncology Group (ECOG) performance status of 0 or 1.\n 3. Have at least 1 target lesion per response evaluation criteria in solid tumors (RECIST) version 1.1.\n 4. Have recovered from toxicities related to prior anticancer therapy to National Cancer Institute common terminology criteria for adverse events (NCI CTCAE) version 4.03 Grade less than or equal to (<=) 1.\n 5. Suitable venous access for study-required blood sampling (that is, including PK and laboratory safety tests).\n\n","\n\n 1. Systemic treatment with strong or moderate cytochrome P450 3A (CYP3A) inhibitors or inducers within 14 days before enrollment.\n 2. Prior therapy with brigatinib.\n 3. Received prior ALK-inhibitor therapy within 7 days before the first dose of study drug.\n 4. Treatment with any investigational systemic anticancer agents within 14 days or 5 half-lives, whichever is longer, before the first dose of study drug.\n 5. Received chemotherapy or radiation therapy within 14 days before the first dose of study drug, except for stereotactic radiosurgery (SRS) or stereotactic body radiation therapy.\n 6. Received antineoplastic monoclonal antibodies within 30 days before the first dose of study drug.\n 7. Had major surgery within 30 days before the first dose of study drug. Minor surgical procedures, such as catheter placement or minimally invasive biopsies, are allowed.\n 8. Have current spinal cord compression (symptomatic or asymptomatic and detected by radiographic imaging). Patients with leptomeningeal disease and without cord compression are allowed.",{"$nulls":4},"Actual","2018-02-05","Actual","Anticipated","2020-08-18","Anticipated","2018-05-01","2018-01-29","2018-01-29","2018-05-03","No","Drug therapy, brigatinib, lung cancer, ALK, ROS1","Interventional","Other","Sequential Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"U1111-1203-0166","WHO","Part A: AUCâˆž: Area Under the Plasma Concentration-Time Curve from Time 0 to Infinity (AUCâˆž) for Midazolam|Part A: Cmax: Maximum Observed Plasma Concentration for Midazolam|Part A: Tmax: Time to Reach the Maximum Observed Plasma Concentration (Cmax) for Midazolam","Days 1 and 21 pre-dose and at multiple time points (up to 24 hours) post-dose",{"$nulls":4},"GlobalOncologyMedinfo@takeda.com","Takeda Study Registration Call Center",{"$f":"1-844-662-8532","v":-10037},{"$nulls":7},"Medical Director","2018-05-03","2020-05-25T16:40:15.402","2020-05-26T17:10:42.972","NCT03420742"]
["5ecbf4efe2561b1b11905f13","NCT03420742","2018-07-03","Ariad","ARIA","Not yet recruiting","A Phase 1 Drug-Drug Interaction Study Between Brigatinib and the CYP3A Substrate, Midazolam, in Patients With ALK-Positive or ROS1-Positive Solid Tumors","Midazolam|Brigatinib","GABA Agonist|TK Inhibitor|ALK Inhibitor","Yes","['Midazolam']","No",null,"Phase 1",1,20,"Anticipated","2018-10-29","2019-06-15","AUC","Area Under The Curve",{"$nulls":3},"The purpose of this study is to characterize the effect of repeat-dose administration of brigatinib 180 milligram (mg) once daily (QD) on the single-dose pharmacokinetics (PK) of midazolam.","The study will enroll approximately 20 participants to achieve approximately 15 PK-evaluable participants for assessment. This study will consist of 2 parts: Part A of the study will evaluate the effect of repeat-dose administration of brigatinib on the single-dose PK of midazolam. Part B of the study is exploratory and will allow participants to continue brigatinib until disease progression (PD). All participants will receive study drug via the oral route. Participants will be assigned to: Midazolam 3 mg + Brigatinib 90 mg.\n\nThe overall time to participate in this study is 26 months. Participants will have a 28-day PK cycle in Part A and a maximum of 23 cycles in Part B, and a 30-day follow-up period after end of treatment.","A Phase 1 Drug-Drug Interaction Study Between Brigatinib and the CYP3A Substrate Midazolam in Patients With ALK-Positive or ROS1-Positive Solid Tumors","Brigatinib-1001","Carcinoma, Advanced ALK+ or ROS1+Non-Small-Cell Lung, Neoplasm, Advanced ALK+ or ROS1+Solid Tumors","Small Cell Lung Cancer|Noma|Carcinoma|Non-Small-Cell Lung Cancer|Small Cell Carcinoma","Oncology Solid Tumor|Mouth Diseases","Oncology|Ear, Nose and Throat","Experimental","Midazolam 3 mg + Brigatinib 90 mg","Midazolam 3 mg, orally, once on Day 1, followed by brigatinib 90 mg, orally, once daily on Days 2 to 8, further followed by brigatinib 180 mg, orally, once daily on Days 9 to 28 in Part A Cycle 1 (28 days treatment cycle). Participants escalating to brigatinib 180 mg once daily will also receive midazolam 3 mg, orally, once on Day 21 of Part A Cycle 1. After completion of Part A, participants will continue into Part B. Participants in Part B will receive brigatinib up to 180 mg (or at the highest tolerated dose in Part A), orally, once daily in a 28 day treatment cycle, up to a maximum of 23 cycles or until progression of disease, unacceptable toxicity, or another discontinuation criterion is met.","Drug","Midazolam|Brigatinib","Midazolam syrup.|Brigatinib tablets.","Alunbrig","Midazolam 3 mg + Brigatinib 90 mg","\n\n 1. Locally advanced or metastatic solid tumors who meet 1 of the following 4 criteria: * With locally advanced or metastatic ALK-positive NSCLC who have progressed on or are intolerant to treatment with at least 1 other ALK inhibitor.\n     * With ALK-positive nonlung solid tumors that are locally advanced or metastatic and for whom no standard, nonexperimental therapy is available.\n     * With locally advanced or metastatic ROS1-positive NSCLC who have progressed on crizotinib therapy or are intolerant to crizotinib, or\n     * With ROS1-positive nonlung solid tumors that are locally advanced or metastatic and for whom no standard, nonexperimental therapy is available.\n    \n    \n 2. Eastern cooperative Oncology Group (ECOG) performance status of 0 or 1.\n 3. Have at least 1 target lesion per response evaluation criteria in solid tumors (RECIST) version 1.1.\n 4. Have recovered from toxicities related to prior anticancer therapy to National Cancer Institute common terminology criteria for adverse events (NCI CTCAE) version 4.03 Grade less than or equal to (<=) 1.\n 5. Suitable venous access for study-required blood sampling (that is, including PK and laboratory safety tests).\n\n","\n\n 1. Systemic treatment with strong or moderate cytochrome P450 3A (CYP3A) inhibitors or inducers within 14 days before enrollment.\n 2. Prior therapy with brigatinib.\n 3. Received prior ALK-inhibitor therapy within 7 days before the first dose of study drug.\n 4. Treatment with any investigational systemic anticancer agents within 14 days or 5 half-lives, whichever is longer, before the first dose of study drug.\n 5. Received chemotherapy or radiation therapy within 14 days before the first dose of study drug, except for stereotactic radiosurgery (SRS) or stereotactic body radiation therapy.\n 6. Received antineoplastic monoclonal antibodies within 30 days before the first dose of study drug.\n 7. Had major surgery within 30 days before the first dose of study drug. Minor surgical procedures, such as catheter placement or minimally invasive biopsies, are allowed.\n 8. Have current spinal cord compression (symptomatic or asymptomatic and detected by radiographic imaging). Patients with leptomeningeal disease and without cord compression are allowed.",{"$nulls":4},"Actual","2018-02-05","Actual","Anticipated","2020-08-18","Anticipated","2018-06-01","2018-01-29","2018-01-29","2018-06-29","No","Drug therapy, brigatinib, lung cancer, ALK, ROS1","Interventional","Other","Sequential Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"U1111-1203-0166|2018-001624-19","WHO|EudraCT Number","Part A: AUCâˆž: Area Under the Plasma Concentration-Time Curve from Time 0 to Infinity (AUCâˆž) for Midazolam|Part A: Cmax: Maximum Observed Plasma Concentration for Midazolam|Part A: Tmax: Time to Reach the Maximum Observed Plasma Concentration (Cmax) for Midazolam","Days 1 and 21 pre-dose and at multiple time points (up to 24 hours) post-dose",{"$nulls":4},"GlobalOncologyMedinfo@takeda.com","Takeda Study Registration Call Center",{"$f":"1-844-662-8532","v":-10037},"Paris, Ile-De-|Marseille, Provence Alpes Cote D'Azur, France, 13005|Bologna, Italy, 40138 Ospedale San RaffaeleMilano, Italy, 20132 Istituto Europeo Di OncologiaMilano, Italy, 20141 Azienda Ospedaliero Universitaria Di ParmaParma, Italy, 43126 Ospedale \"Degli Infermi\" Di FaenzaRavenna, Italy, 48121|Aviano, Pordenone, Italy, 33081|Amsterdam, Noord-Holland, Netherlands, 1006 Cx|Barcelona, Spain, 08028 Hospital Universitari Vall D'HebronBarcelona, Spain, 08035 Hospital Universitario Fundacion Jimenez DiazMadrid, Spain, 28040 Hm Centro Integral Oncologico Clara CampalMadrid, Spain, 28050 Hospital Universitario Ramon Y CajalMadrid, Spain, 38034|Barakaldo, Vizcaya, Spain, 48903",null,"France|Italy|Netherlands|Spain","Bichat|Provence Alpes Cote D'Azur Hopital De La Timone|Policlinico Sant'Orsola Malpighi|Pordenone Centro Di Riferimento Oncologico Di Aviano|Cancer Institute|Hospital Universitario Dexeus|Vizcaya Hospital Universitario Dexeus,",{"$nulls":3},"Medical Director","2018-06-29","2020-05-25T16:40:15.486","2020-05-26T17:10:42.972","NCT03420742"]
["5ecbf4ef307e3d1b1f8d9eab","NCT03420742","2018-08-17","Ariad","ARIA","Not yet recruiting","A Phase 1 Drug-Drug Interaction Study Between Brigatinib and the CYP3A Substrate, Midazolam, in Patients With ALK-Positive or ROS1-Positive Solid Tumors","Midazolam|Brigatinib","GABA Agonist|TK Inhibitor|ALK Inhibitor","Yes","['Midazolam']","No",null,"Phase 1",1,20,"Anticipated","2018-10-29","2019-06-15","AUC","Area Under The Curve",{"$nulls":3},"The purpose of this study is to characterize the effect of repeat-dose administration of brigatinib 180 milligram (mg) once daily (QD) on the single-dose pharmacokinetics (PK) of midazolam.","The study will enroll approximately 20 participants to achieve approximately 15 PK-evaluable participants for assessment. This study will consist of 2 parts: Part A of the study will evaluate the effect of repeat-dose administration of brigatinib on the single-dose PK of midazolam. Part B of the study is exploratory and will allow participants to continue brigatinib until disease progression (PD). All participants will receive study drug via the oral route. Participants will be assigned to: Midazolam 3 mg + Brigatinib 90 mg.\n\nThe overall time to participate in this study is 26 months. Participants will have a 28-day PK cycle in Part A and a maximum of 23 cycles in Part B, and a 30-day follow-up period after end of treatment.","A Phase 1 Drug-Drug Interaction Study Between Brigatinib and the CYP3A Substrate Midazolam in Patients With ALK-Positive or ROS1-Positive Solid Tumors","Brigatinib-1001","Carcinoma, Advanced ALK+ or ROS1+Non-Small-Cell Lung, Neoplasm, Advanced ALK+ or ROS1+Solid Tumors","Small Cell Lung Cancer|Noma|Carcinoma|Non-Small-Cell Lung Cancer|Small Cell Carcinoma","Oncology Solid Tumor|Mouth Diseases","Oncology|Ear, Nose and Throat","Experimental","Midazolam 3 mg + Brigatinib 90 mg","Midazolam 3 mg, orally, once on Day 1, followed by brigatinib 90 mg, orally, once daily on Days 2 to 8, further followed by brigatinib 180 mg, orally, once daily on Days 9 to 28 in Part A Cycle 1 (28 days treatment cycle). Participants escalating to brigatinib 180 mg once daily will also receive midazolam 3 mg, orally, once on Day 21 of Part A Cycle 1. After completion of Part A, participants will continue into Part B. Participants in Part B will receive brigatinib up to 180 mg (or at the highest tolerated dose in Part A), orally, once daily in a 28 day treatment cycle, up to a maximum of 23 cycles or until progression of disease, unacceptable toxicity, or another discontinuation criterion is met.","Drug","Midazolam|Brigatinib","Midazolam syrup.|Brigatinib tablets.","Alunbrig","Midazolam 3 mg + Brigatinib 90 mg","\n\n 1. Locally advanced or metastatic solid tumors who meet 1 of the following 4 criteria: * With locally advanced or metastatic ALK-positive NSCLC who have progressed on or are intolerant to treatment with at least 1 other ALK inhibitor.\n     * With ALK-positive nonlung solid tumors that are locally advanced or metastatic and for whom no standard, nonexperimental therapy is available.\n     * With locally advanced or metastatic ROS1-positive NSCLC who have progressed on crizotinib therapy or are intolerant to crizotinib, or\n     * With ROS1-positive nonlung solid tumors that are locally advanced or metastatic and for whom no standard, nonexperimental therapy is available.\n    \n    \n 2. Eastern cooperative Oncology Group (ECOG) performance status of 0 or 1.\n 3. Have at least 1 target lesion per response evaluation criteria in solid tumors (RECIST) version 1.1.\n 4. Have recovered from toxicities related to prior anticancer therapy to National Cancer Institute common terminology criteria for adverse events (NCI CTCAE) version 4.03 Grade less than or equal to (<=) 1.\n 5. Suitable venous access for study-required blood sampling (that is, including PK and laboratory safety tests).\n\n","\n\n 1. Systemic treatment with strong or moderate cytochrome P450 3A (CYP3A) inhibitors or inducers within 14 days before enrollment.\n 2. Prior therapy with brigatinib.\n 3. Received prior ALK-inhibitor therapy within 7 days before the first dose of study drug.\n 4. Treatment with any investigational systemic anticancer agents within 14 days or 5 half-lives, whichever is longer, before the first dose of study drug.\n 5. Received chemotherapy or radiation therapy within 14 days before the first dose of study drug, except for stereotactic radiosurgery (SRS) or stereotactic body radiation therapy.\n 6. Received antineoplastic monoclonal antibodies within 30 days before the first dose of study drug.\n 7. Had major surgery within 30 days before the first dose of study drug. Minor surgical procedures, such as catheter placement or minimally invasive biopsies, are allowed.\n 8. Have current spinal cord compression (symptomatic or asymptomatic and detected by radiographic imaging). Patients with leptomeningeal disease and without cord compression are allowed.",{"$nulls":4},"Actual","2018-02-05","Actual","Anticipated","2020-08-18","Anticipated","2018-08-01","2018-01-29","2018-01-29","2018-08-16","No","Drug therapy, brigatinib, lung cancer, ALK, ROS1","Interventional","Other","Sequential Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":17},"U1111-1203-0166|2018-001624-19","WHO|EudraCT Number","Part A: AUCâˆž: Area Under the Plasma Concentration-Time Curve from Time 0 to Infinity (AUCâˆž) for Midazolam|Part A: Cmax: Maximum Observed Plasma Concentration for Midazolam|Part A: Tmax: Time to Reach the Maximum Observed Plasma Concentration (Cmax) for Midazolam","Days 1 and 21 pre-dose and at multiple time points (up to 24 hours) post-dose",{"$nulls":4},"GlobalOncologyMedinfo@takeda.com","Takeda Study Registration Call Center",{"$f":"1-844-662-8532","v":-10037},"Paris, Ile-De-|Marseille, Provence Alpes Cote D'Azur, France, 13005|Bologna, Italy, 40138 Ospedale San RaffaeleMilano, Italy, 20132 Istituto Europeo Di OncologiaMilano, Italy, 20141 Azienda Ospedaliero Universitaria Di ParmaParma, Italy, 43126 Ospedale \"Degli Infermi\" Di FaenzaRavenna, Italy, 48121|Aviano, Pordenone, Italy, 33081|Amsterdam, Noord-Holland, Netherlands, 1006 Cx|Barcelona, Spain, 08028 Hospital Universitari Vall D'HebronBarcelona, Spain, 08035 Hospital Universitario Ramon Y CajalMadrid, Spain, 28034 Hospital Universitario Fundacion Jimenez DiazMadrid, Spain, 28040 Hm Centro Integral Oncologico Clara CampalMadrid, Spain, 28050|Barakaldo, Vizcaya, Spain, 48903",null,"France|Italy|Netherlands|Spain","Hospital|Provence Alpes Cote D'Azur Hospital De La Timone|Policlinico Sant'Orsola Malpighi|Pordenone Centro Di Riferimento Oncologico Di Aviano|Cancer Institute|Hospital Universitario Dexeus|Vizcaya Hospital Universitario Dexeus,",{"$nulls":3},"Medical Director","2018-08-16","2020-05-25T16:40:15.764","2020-05-26T17:10:42.972","NCT03420742"]
["5ecbf4effe30261b1a048419","NCT03420742","2018-09-07","Ariad","ARIA","Not yet recruiting","A Phase 1 Drug-Drug Interaction Study Between Brigatinib and the CYP3A Substrate, Midazolam, in Patients With ALK-Positive or ROS1-Positive Solid Tumors","Midazolam|Brigatinib","GABA Agonist|TK Inhibitor|ALK Inhibitor","Yes","['Midazolam']","No",null,"Phase 1",1,20,"Anticipated","2018-10-29","2019-06-15","AUC","Area Under The Curve",{"$nulls":3},"The purpose of this study is to characterize the effect of repeat-dose administration of brigatinib 180 milligram (mg) once daily (QD) on the single-dose pharmacokinetics (PK) of midazolam.","The study will enroll approximately 20 participants to achieve approximately 15 PK-evaluable participants for assessment. This study will consist of 2 parts: Part A of the study will evaluate the effect of repeat-dose administration of brigatinib on the single-dose PK of midazolam. Part B of the study is exploratory and will allow participants to continue brigatinib until disease progression (PD). All participants will receive study drug via the oral route. Participants will be assigned to: Midazolam 3 mg + Brigatinib 90 mg.\n\nThe overall time to participate in this study is 26 months. Participants will have a 28-day PK cycle in Part A and a maximum of 23 cycles in Part B, and a 30-day follow-up period after end of treatment.","A Phase 1 Drug-Drug Interaction Study Between Brigatinib and the CYP3A Substrate Midazolam in Patients With ALK-Positive or ROS1-Positive Solid Tumors","Brigatinib-1001","Carcinoma, Advanced ALK+ or ROS1+Non-Small-Cell Lung, Neoplasm, Advanced ALK+ or ROS1+Solid Tumors","Small Cell Lung Cancer|Noma|Carcinoma|Non-Small-Cell Lung Cancer|Small Cell Carcinoma","Oncology Solid Tumor|Mouth Diseases","Oncology|Ear, Nose and Throat","Experimental","Midazolam 3 mg + Brigatinib 90 mg","Midazolam 3 mg, orally, once on Day 1, followed by brigatinib 90 mg, orally, once daily on Days 2 to 8, further followed by brigatinib 180 mg, orally, once daily on Days 9 to 28 in Part A Cycle 1 (28 days treatment cycle). Participants escalating to brigatinib 180 mg once daily will also receive midazolam 3 mg, orally, once on Day 21 of Part A Cycle 1. After completion of Part A, participants will continue into Part B. Participants in Part B will receive brigatinib up to 180 mg (or at the highest tolerated dose in Part A), orally, once daily in a 28 day treatment cycle, up to a maximum of 23 cycles or until progression of disease, unacceptable toxicity, or another discontinuation criterion is met.","Drug","Midazolam|Brigatinib","Midazolam syrup.|Brigatinib tablets.","Alunbrig","Midazolam 3 mg + Brigatinib 90 mg","\n\n 1. Locally advanced or metastatic solid tumors who meet 1 of the following 4 criteria: * With locally advanced or metastatic ALK-positive NSCLC who have progressed on or are intolerant to treatment with at least 1 other ALK inhibitor.\n     * With ALK-positive nonlung solid tumors that are locally advanced or metastatic and for whom no standard, nonexperimental therapy is available.\n     * With locally advanced or metastatic ROS1-positive NSCLC who have progressed on crizotinib therapy or are intolerant to crizotinib, or\n     * With ROS1-positive nonlung solid tumors that are locally advanced or metastatic and for whom no standard, nonexperimental therapy is available.\n    \n    \n 2. Eastern cooperative Oncology Group (ECOG) performance status of 0 or 1.\n 3. Have at least 1 target lesion per response evaluation criteria in solid tumors (RECIST) version 1.1.\n 4. Have recovered from toxicities related to prior anticancer therapy to National Cancer Institute common terminology criteria for adverse events (NCI CTCAE) version 4.03 Grade less than or equal to (<=) 1.\n 5. Suitable venous access for study-required blood sampling (that is, including PK and laboratory safety tests).\n\n","\n\n 1. Systemic treatment with strong or moderate cytochrome P450 3A (CYP3A) inhibitors or inducers within 14 days before enrollment.\n 2. Prior therapy with brigatinib.\n 3. Received prior ALK-inhibitor therapy within 7 days before the first dose of study drug.\n 4. Treatment with any investigational systemic anticancer agents within 14 days or 5 half-lives, whichever is longer, before the first dose of study drug.\n 5. Received chemotherapy or radiation therapy within 14 days before the first dose of study drug, except for stereotactic radiosurgery (SRS) or stereotactic body radiation therapy.\n 6. Received antineoplastic monoclonal antibodies within 30 days before the first dose of study drug.\n 7. Had major surgery within 30 days before the first dose of study drug. Minor surgical procedures, such as catheter placement or minimally invasive biopsies, are allowed.\n 8. Have current spinal cord compression (symptomatic or asymptomatic and detected by radiographic imaging). Patients with leptomeningeal disease and without cord compression are allowed.",{"$nulls":4},"Actual","2018-02-05","Actual","Anticipated","2020-08-18","Anticipated","2018-09-01","2018-01-29","2018-01-29","2018-09-05","No","Drug therapy, brigatinib, lung cancer, ALK, ROS1","Interventional","Other","Sequential Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No","Yes\nTakeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/Approach for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.",{"$nulls":3},"Yes","No",{"$nulls":17},"U1111-1203-0166|2018-001624-19","WHO|EudraCT Number","Part A: AUCâˆž: Area Under the Plasma Concentration-Time Curve from Time 0 to Infinity (AUCâˆž) for Midazolam|Part A: Cmax: Maximum Observed Plasma Concentration for Midazolam|Part A: Tmax: Time to Reach the Maximum Observed Plasma Concentration (Cmax) for Midazolam","Days 1 and 21 pre-dose and at multiple time points (up to 24 hours) post-dose",{"$nulls":4},"GlobalOncologyMedinfo@takeda.com","Takeda Study Registration Call Center",{"$f":"1-866-835-2233","v":-3933},"Paris, Ile-De-|Marseille, Provence Alpes Cote D'Azur, France, 13005|Bologna, Italy, 40138 Ospedale San RaffaeleMilano, Italy, 20132 Istituto Europeo Di OncologiaMilano, Italy, 20141 Azienda Ospedaliero Universitaria Di ParmaParma, Italy, 43126 Ospedale \"Degli Infermi\" Di FaenzaRavenna, Italy, 48121|Aviano, Pordenone, Italy, 33081|Amsterdam, Noord-Holland, Netherlands, 1006 Cx|Barcelona, Spain, 08028 Hospital Universitari Vall D'HebronBarcelona, Spain, 08035 Hospital Universitario Ramon Y CajalMadrid, Spain, 28034 Hospital Universitario Fundacion Jimenez DiazMadrid, Spain, 28040 Hm Centro Integral Oncologico Clara CampalMadrid, Spain, 28050|Barakaldo, Vizcaya, Spain, 48903",null,"France|Italy|Netherlands|Spain","Hospital|Provence Alpes Cote D'Azur Hospital De La Timone|Policlinico Sant'Orsola Malpighi|Pordenone Centro Di Riferimento Oncologico Di Aviano|Cancer Institute|Hospital Universitario Dexeus|Vizcaya Hospital Universitario Dexeus,",{"$nulls":3},"Medical Director","2018-09-05","2020-05-25T16:40:15.497","2020-05-26T17:10:42.972","NCT03420742"]
["5ecbf4effe30261b1a04841a","NCT03420742","2018-09-14","Ariad","ARIA","Not yet recruiting","A Phase 1 Drug-Drug Interaction Study Between Brigatinib and the CYP3A Substrate, Midazolam, in Patients With ALK-Positive or ROS1-Positive Solid Tumors","Midazolam|Brigatinib","GABA Agonist|TK Inhibitor|ALK Inhibitor","Yes","['Midazolam']","No",null,"Phase 1",1,20,"Anticipated","2018-10-29","2019-06-15","AUC","Area Under The Curve",{"$nulls":3},"The purpose of this study is to characterize the effect of repeat-dose administration of brigatinib 180 milligram (mg) once daily (QD) on the single-dose pharmacokinetics (PK) of midazolam.","The study will enroll approximately 20 participants to achieve approximately 15 PK-evaluable participants for assessment. This study will consist of 2 parts: Part A of the study will evaluate the effect of repeat-dose administration of brigatinib on the single-dose PK of midazolam. Part B of the study is exploratory and will allow participants to continue brigatinib until disease progression (PD). All participants will receive study drug via the oral route. Participants will be assigned to: Midazolam 3 mg + Brigatinib 90 mg.\n\nThe overall time to participate in this study is 26 months. Participants will have a 28-day PK cycle in Part A and a maximum of 23 cycles in Part B, and a 30-day follow-up period after end of treatment.","A Phase 1 Drug-Drug Interaction Study Between Brigatinib and the CYP3A Substrate Midazolam in Patients With ALK-Positive or ROS1-Positive Solid Tumors","Brigatinib-1001","Carcinoma, Advanced ALK+ or ROS1+Non-Small-Cell Lung, Neoplasm, Advanced ALK+ or ROS1+Solid Tumors","Small Cell Lung Cancer|Noma|Carcinoma|Non-Small-Cell Lung Cancer|Small Cell Carcinoma","Oncology Solid Tumor|Mouth Diseases","Oncology|Ear, Nose and Throat","Experimental","Midazolam 3 mg + Brigatinib 90 mg","Midazolam 3 mg, orally, once on Day 1, followed by brigatinib 90 mg, orally, once daily on Days 2 to 8, further followed by brigatinib 180 mg, orally, once daily on Days 9 to 28 in Part A Cycle 1 (28 days treatment cycle). Participants escalating to brigatinib 180 mg once daily will also receive midazolam 3 mg, orally, once on Day 21 of Part A Cycle 1. After completion of Part A, participants will continue into Part B. Participants in Part B will receive brigatinib up to 180 mg (or at the highest tolerated dose in Part A), orally, once daily in a 28 day treatment cycle, up to a maximum of 23 cycles or until progression of disease, unacceptable toxicity, or another discontinuation criterion is met.","Drug","Midazolam|Brigatinib","Midazolam syrup.|Brigatinib tablets.","Alunbrig","Midazolam 3 mg + Brigatinib 90 mg","\n\n 1. Locally advanced or metastatic solid tumors who meet 1 of the following 4 criteria: * With locally advanced or metastatic ALK-positive NSCLC who have progressed on or are intolerant to treatment with at least 1 other ALK inhibitor.\n     * With ALK-positive nonlung solid tumors that are locally advanced or metastatic and for whom no standard, nonexperimental therapy is available.\n     * With locally advanced or metastatic ROS1-positive NSCLC who have progressed on crizotinib therapy or are intolerant to crizotinib, or\n     * With ROS1-positive nonlung solid tumors that are locally advanced or metastatic and for whom no standard, nonexperimental therapy is available.\n    \n    \n 2. Eastern cooperative Oncology Group (ECOG) performance status of 0 or 1.\n 3. Have at least 1 target lesion per response evaluation criteria in solid tumors (RECIST) version 1.1.\n 4. Have recovered from toxicities related to prior anticancer therapy to National Cancer Institute common terminology criteria for adverse events (NCI CTCAE) version 4.03 Grade less than or equal to (<=) 1.\n 5. Suitable venous access for study-required blood sampling (that is, including PK and laboratory safety tests).\n\n","\n\n 1. Systemic treatment with strong or moderate cytochrome P450 3A (CYP3A) inhibitors or inducers within 14 days before enrollment.\n 2. Prior therapy with brigatinib.\n 3. Received prior ALK-inhibitor therapy within 7 days before the first dose of study drug.\n 4. Treatment with any investigational systemic anticancer agents within 14 days or 5 half-lives, whichever is longer, before the first dose of study drug.\n 5. Received chemotherapy or radiation therapy within 14 days before the first dose of study drug, except for stereotactic radiosurgery (SRS) or stereotactic body radiation therapy.\n 6. Received antineoplastic monoclonal antibodies within 30 days before the first dose of study drug.\n 7. Had major surgery within 30 days before the first dose of study drug. Minor surgical procedures, such as catheter placement or minimally invasive biopsies, are allowed.\n 8. Have current spinal cord compression (symptomatic or asymptomatic and detected by radiographic imaging). Patients with leptomeningeal disease and without cord compression are allowed.",{"$nulls":4},"Actual","2018-02-05","Actual","Anticipated","2020-08-18","Anticipated","2018-09-01","2018-01-29","2018-01-29","2018-09-13","No","Drug therapy, brigatinib, lung cancer, ALK, ROS1","Interventional","Other","Sequential Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No","Yes\nTakeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/Approach for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.",{"$nulls":3},"Yes","No",{"$nulls":17},"U1111-1203-0166|2018-001624-19","WHO|EudraCT Number","Part A: AUCâˆž: Area Under the Plasma Concentration-Time Curve from Time 0 to Infinity (AUCâˆž) for Midazolam|Part A: Cmax: Maximum Observed Plasma Concentration for Midazolam|Part A: Tmax: Time to Reach the Maximum Observed Plasma Concentration (Cmax) for Midazolam","Days 1 and 21 pre-dose and at multiple time points (up to 24 hours) post-dose",{"$nulls":4},"GlobalOncologyMedinfo@takeda.com","Takeda Study Registration Call Center",-3933,"Paris, Ile-De-|Marseille, Provence Alpes Cote D'Azur, France, 13005|Bologna, Italy, 40138 Ospedale San RaffaeleMilano, Italy, 20132 Istituto Europeo Di OncologiaMilano, Italy, 20141 Azienda Ospedaliero Universitaria Di ParmaParma, Italy, 43126 Ospedale \"Degli Infermi\" Di FaenzaRavenna, Italy, 48121|Aviano, Pordenone, Italy, 33081|Amsterdam, Noord-Holland, Netherlands, 1006 Cx|Barcelona, Spain, 08028 Hospital Universitari Vall D'HebronBarcelona, Spain, 08035 Hospital Universitario Ramon Y CajalMadrid, Spain, 28034 Hospital Universitario Fundacion Jimenez DiazMadrid, Spain, 28040 Hm Centro Integral Oncologico Clara CampalMadrid, Spain, 28050|Barakaldo, Vizcaya, Spain, 48903",null,"France|Italy|Netherlands|Spain","Groupe Hospitalier Bichat-Claude Bernard - Hopital Bichat|Provence Alpes Cote D'Azur Hopital De La Timone|Policlinico Sant'Orsola Malpighi|Pordenone Centro Di Riferimento Oncologico Di Aviano|Cancer Institute|Hospital Universitario Dexeus|Vizcaya Hospital Universitario Dexeus,",{"$nulls":3},"Medical Director","2018-09-13","2020-05-25T16:40:15.847","2020-05-26T17:10:42.972","NCT03420742"]
["5ecbf4effeab101b15530a49","NCT03420742","2018-12-07","Ariad","ARIA","Not yet recruiting","A Phase 1 Drug-Drug Interaction Study Between Brigatinib and the CYP3A Substrate, Midazolam, in Patients With ALK-Positive or ROS1-Positive Solid Tumors","Midazolam|Brigatinib","GABA Agonist|TK Inhibitor|ALK Inhibitor","Yes","['Midazolam']","No",null,"Phase 1",1,20,"Anticipated","2019-01-10","2019-06-15","AUC","Area Under The Curve",{"$nulls":3},"The purpose of this study is to characterize the effect of repeat-dose administration of brigatinib 180 milligram (mg) once daily (QD) on the single-dose pharmacokinetics (PK) of midazolam.","The study will enroll approximately 20 participants to achieve approximately 15 PK-evaluable participants for assessment. This study will consist of 2 parts: Part A of the study will evaluate the effect of repeat-dose administration of brigatinib on the single-dose PK of midazolam. Part B of the study is exploratory and will allow participants to continue brigatinib until disease progression (PD). All participants will receive study drug via the oral route. Participants will be assigned to: Midazolam 3 mg + Brigatinib 90 mg.\n\nThe overall time to participate in this study is 26 months. Participants will have a 28-day PK cycle in Part A and a maximum of 23 cycles in Part B, and a 30-day follow-up period after end of treatment.","A Phase 1 Drug-Drug Interaction Study Between Brigatinib and the CYP3A Substrate Midazolam in Patients With ALK-Positive or ROS1-Positive Solid Tumors","Brigatinib-1001","Carcinoma, Advanced ALK+ or ROS1+Non-Small-Cell Lung, Neoplasm, Advanced ALK+ or ROS1+Solid Tumors","Small Cell Lung Cancer|Noma|Carcinoma|Non-Small-Cell Lung Cancer|Small Cell Carcinoma","Oncology Solid Tumor|Mouth Diseases","Oncology|Ear, Nose and Throat","Experimental","Midazolam 3 mg + Brigatinib 90 mg","Midazolam 3 mg, orally, once on Day 1, followed by brigatinib 90 mg, orally, once daily on Days 2 to 8, further followed by brigatinib 180 mg, orally, once daily on Days 9 to 28 in Part A Cycle 1 (28 days treatment cycle). Participants escalating to brigatinib 180 mg once daily will also receive midazolam 3 mg, orally, once on Day 21 of Part A Cycle 1. After completion of Part A, participants will continue into Part B. Participants in Part B will receive brigatinib up to 180 mg (or at the highest tolerated dose in Part A), orally, once daily in a 28 day treatment cycle, up to a maximum of 23 cycles or until progression of disease, unacceptable toxicity, or another discontinuation criterion is met.","Drug","Midazolam|Brigatinib","Midazolam syrup.|Brigatinib tablets.","Alunbrig","Midazolam 3 mg + Brigatinib 90 mg","\n\n 1. Locally advanced or metastatic solid tumors who meet 1 of the following 4 criteria: * With locally advanced or metastatic ALK-positive NSCLC who have progressed on or are intolerant to treatment with at least 1 other ALK inhibitor.\n     * With ALK-positive nonlung solid tumors that are locally advanced or metastatic and for whom no standard, nonexperimental therapy is available.\n     * With locally advanced or metastatic ROS1-positive NSCLC who have progressed on crizotinib therapy or are intolerant to crizotinib, or\n     * With ROS1-positive nonlung solid tumors that are locally advanced or metastatic and for whom no standard, nonexperimental therapy is available.\n    \n    \n 2. Eastern cooperative Oncology Group (ECOG) performance status of 0 or 1.\n 3. Have at least 1 target lesion per response evaluation criteria in solid tumors (RECIST) version 1.1.\n 4. Have recovered from toxicities related to prior anticancer therapy to National Cancer Institute common terminology criteria for adverse events (NCI CTCAE) version 4.03 Grade less than or equal to (<=) 1.\n 5. Suitable venous access for study-required blood sampling (that is, including PK and laboratory safety tests).\n\n","\n\n 1. Systemic treatment with strong or moderate cytochrome P450 3A (CYP3A) inhibitors or inducers within 14 days before enrollment.\n 2. Prior therapy with brigatinib.\n 3. Received prior ALK-inhibitor therapy within 7 days before the first dose of study drug.\n 4. Treatment with any investigational systemic anticancer agents within 14 days or 5 half-lives, whichever is longer, before the first dose of study drug.\n 5. Received chemotherapy or radiation therapy within 14 days before the first dose of study drug, except for stereotactic radiosurgery (SRS) or stereotactic body radiation therapy.\n 6. Received antineoplastic monoclonal antibodies within 30 days before the first dose of study drug.\n 7. Had major surgery within 30 days before the first dose of study drug. Minor surgical procedures, such as catheter placement or minimally invasive biopsies, are allowed.\n 8. Have current spinal cord compression (symptomatic or asymptomatic and detected by radiographic imaging). Patients with leptomeningeal disease and without cord compression are allowed.",{"$nulls":4},"Actual","2018-02-05","Actual","Anticipated","2020-08-18","Anticipated","2018-12-01","2018-01-29","2018-01-29","2018-12-06","No","Drug therapy, brigatinib, lung cancer, ALK, ROS1","Interventional","Other","Sequential Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No","Yes\nTakeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/Approach for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.",{"$nulls":3},"Yes","No",{"$nulls":17},"U1111-1203-0166|2018-001624-19","WHO|EudraCT Number","Part A: AUCâˆž: Area Under the Plasma Concentration-Time Curve from Time 0 to Infinity (AUCâˆž) for Midazolam|Part A: Cmax: Maximum Observed Plasma Concentration for Midazolam|Part A: Tmax: Time to Reach the Maximum Observed Plasma Concentration (Cmax) for Midazolam","Days 1 and 21 pre-dose and at multiple time points (up to 24 hours) post-dose",{"$nulls":4},"GlobalOncologyMedinfo@takeda.com","Takeda Study Registration Call Center",-3933,"Paris, Ile-De-|Marseille Cedex 5, Provence Alpes Cote D'Azur, France, 13385 Hopital De La TimoneMarseille, Provence Alpes Cote D'Azur, France, 13005|Bologna, Italy, 40138 Ospedale San RaffaeleMilano, Italy, 20132 Istituto Europeo Di OncologiaMilano, Italy, 20141 Azienda Ospedaliero Universitaria Di ParmaParma, Italy, 43126 Ospedale \"Degli Infermi\" Di FaenzaRavenna, Italy, 48121|Aviano, Pordenone, Italy, 33081|Amsterdam, Noord-Holland, Netherlands, 1006 Cx|Barcelona, Spain, 08028 Hospital Universitari Vall D'HebronBarcelona, Spain, 08035 Hospital Universitario Ramon Y CajalMadrid, Spain, 28034 Hospital Universitario Fundacion Jimenez DiazMadrid, Spain, 28040 Hm Centro Integral Oncologico Clara CampalMadrid, Spain, 28050|Barakaldo, Vizcaya, Spain, 48903",null,"France|Italy|Netherlands|Spain","Groupe Hospitalier Bichat-Claude Bernard - Hopital Bichat|Provence Alpes Cote D'Azur Hopital De La Timone|Policlinico Sant'Orsola Malpighi|Pordenone Centro Di Riferimento Oncologico Di Aviano|Cancer Institute|Hospital Universitario Dexeus|Vizcaya Hospital Universitario Dexeus,",{"$nulls":3},"Medical Director","2018-12-06","2020-05-25T16:40:15.711","2020-05-26T17:10:42.972","NCT03420742"]
["5ecbf4efe2561b1b11905f14","NCT03420742","2019-01-09","Ariad","ARIA","Not yet recruiting","A Phase 1 Drug-Drug Interaction Study Between Brigatinib and the CYP3A Substrate, Midazolam, in Patients With ALK-Positive or ROS1-Positive Solid Tumors","Midazolam|Brigatinib","GABA Agonist|TK Inhibitor|ALK Inhibitor","Yes","['Midazolam']","No",null,"Phase 1",1,20,"Anticipated","2019-01-10","2019-06-15","AUC","Area Under The Curve",{"$nulls":3},"The purpose of this study is to characterize the effect of repeat-dose administration of brigatinib 180 milligram (mg) once daily (QD) on the single-dose pharmacokinetics (PK) of midazolam.","The study will enroll approximately 20 participants to achieve approximately 15 PK-evaluable participants for assessment. This study will consist of 2 parts: Part A of the study will evaluate the effect of repeat-dose administration of brigatinib on the single-dose PK of midazolam. Part B of the study is exploratory and will allow participants to continue brigatinib until disease progression (PD). All participants will receive study drug via the oral route. Participants will be assigned to: Midazolam 3 mg + Brigatinib 90 mg.\n\nThe overall time to participate in this study is 26 months. Participants will have a 28-day PK cycle in Part A and a maximum of 23 cycles in Part B, and a 30-day follow-up period after end of treatment.","A Phase 1 Drug-Drug Interaction Study Between Brigatinib and the CYP3A Substrate Midazolam in Patients With ALK-Positive or ROS1-Positive Solid Tumors","Brigatinib-1001","Carcinoma, Advanced ALK+ or ROS1+Non-Small-Cell Lung, Neoplasm, Advanced ALK+ or ROS1+Solid Tumors","Small Cell Lung Cancer|Noma|Carcinoma|Non-Small-Cell Lung Cancer|Small Cell Carcinoma","Oncology Solid Tumor|Mouth Diseases","Oncology|Ear, Nose and Throat","Experimental","Midazolam 3 mg + Brigatinib 90 mg","Midazolam 3 mg, orally, once on Day 1, followed by brigatinib 90 mg, orally, once daily on Days 2 to 8, further followed by brigatinib 180 mg, orally, once daily on Days 9 to 28 in Part A Cycle 1 (28 days treatment cycle). Participants escalating to brigatinib 180 mg once daily will also receive midazolam 3 mg, orally, once on Day 21 of Part A Cycle 1. After completion of Part A, participants will continue into Part B. Participants in Part B will receive brigatinib up to 180 mg (or at the highest tolerated dose in Part A), orally, once daily in a 28 day treatment cycle, up to a maximum of 23 cycles or until progression of disease, unacceptable toxicity, or another discontinuation criterion is met.","Drug","Midazolam|Brigatinib","Midazolam syrup.|Brigatinib tablets.","Alunbrig","Midazolam 3 mg + Brigatinib 90 mg","\n\n 1. Locally advanced or metastatic solid tumors who meet 1 of the following 4 criteria: * With locally advanced or metastatic ALK-positive NSCLC who have progressed on or are intolerant to treatment with at least 1 other ALK inhibitor.\n     * With ALK-positive nonlung solid tumors that are locally advanced or metastatic and for whom no standard, nonexperimental therapy is available.\n     * With locally advanced or metastatic ROS1-positive NSCLC who have progressed on crizotinib therapy or are intolerant to crizotinib, or\n     * With ROS1-positive nonlung solid tumors that are locally advanced or metastatic and for whom no standard, nonexperimental therapy is available.\n    \n    \n 2. Eastern cooperative Oncology Group (ECOG) performance status of 0 or 1.\n 3. Have at least 1 target lesion per response evaluation criteria in solid tumors (RECIST) version 1.1.\n 4. Have recovered from toxicities related to prior anticancer therapy to National Cancer Institute common terminology criteria for adverse events (NCI CTCAE) version 4.03 Grade less than or equal to (<=) 1.\n 5. Suitable venous access for study-required blood sampling (that is, including PK and laboratory safety tests).\n\n","\n\n 1. Systemic treatment with strong or moderate cytochrome P450 3A (CYP3A) inhibitors or inducers within 14 days before enrollment.\n 2. Prior therapy with brigatinib.\n 3. Received prior ALK-inhibitor therapy within 7 days before the first dose of study drug.\n 4. Treatment with any investigational systemic anticancer agents within 14 days or 5 half-lives, whichever is longer, before the first dose of study drug.\n 5. Received chemotherapy or radiation therapy within 14 days before the first dose of study drug, except for stereotactic radiosurgery (SRS) or stereotactic body radiation therapy.\n 6. Received antineoplastic monoclonal antibodies within 30 days before the first dose of study drug.\n 7. Had major surgery within 30 days before the first dose of study drug. Minor surgical procedures, such as catheter placement or minimally invasive biopsies, are allowed.\n 8. Have current spinal cord compression (symptomatic or asymptomatic and detected by radiographic imaging). Patients with leptomeningeal disease and without cord compression are allowed.",{"$nulls":4},"Actual","2018-02-05","Actual","Anticipated","2020-08-18","Anticipated","2019-01-01","2018-01-29","2018-01-29","2019-01-08","No","Drug therapy, brigatinib, lung cancer, ALK, ROS1","Interventional","Other","Sequential Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No","Yes\nTakeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/Approach for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.",{"$nulls":3},"Yes","No",{"$nulls":17},"U1111-1203-0166|2018-001624-19","WHO|EudraCT Number","Part A: AUCâˆž: Area Under the Plasma Concentration-Time Curve from Time 0 to Infinity (AUCâˆž) for Midazolam|Part A: Cmax: Maximum Observed Plasma Concentration for Midazolam|Part A: Tmax: Time to Reach the Maximum Observed Plasma Concentration (Cmax) for Midazolam","Days 1 and 21 pre-dose and at multiple time points (up to 24 hours) post-dose",{"$nulls":4},"GlobalOncologyMedinfo@takeda.com","Takeda Study Registration Call Center",-3933,"Paris, Ile-De-|Marseille Cedex 5, Provence Alpes Cote D'Azur, France, 13385 Hopital De La TimoneMarseille, Provence Alpes Cote D'Azur, France, 13005|Bologna, Italy, 40138 Ospedale San RaffaeleMilano, Italy, 20132 Istituto Europeo Di OncologiaMilano, Italy, 20141 Azienda Ospedaliero Universitaria Di ParmaParma, Italy, 43126 Ospedale Santa Maria Delle CrociRavenna, Italy, 48121|Aviano, Pordenone, Italy, 33081|Amsterdam, Noord-Holland, Netherlands, 1006 Cx|Barcelona, Spain, 08028 Hospital Universitari Vall D'HebronBarcelona, Spain, 08035 Hospital Universitario Ramon Y CajalMadrid, Spain, 28034 Hospital Universitario Fundacion Jimenez DiazMadrid, Spain, 28040 Hm Centro Integral Oncologico Clara CampalMadrid, Spain, 28050|Barakaldo, Vizcaya, Spain, 48903",null,"France|Italy|Netherlands|Spain","Groupe Hospitalier Bichat-Claude Bernard - Hopital Bichat|Provence Alpes Cote D'Azur Hopital De La Timone|Policlinico Sant'Orsola Malpighi|Pordenone Centro Di Riferimento Oncologico Di Aviano|Cancer Institute|Hospital Universitario Dexeus|Vizcaya Hospital Universitario Dexeus,",{"$nulls":3},"Medical Director","2019-01-08","2020-05-25T16:40:15.744","2020-05-26T17:10:42.972","NCT03420742"]
["5ecbf4ef11702c1b1b916c26","NCT03420742","2019-02-07","Ariad","ARIA","Not yet recruiting","A Phase 1 Drug-Drug Interaction Study Between Brigatinib and the CYP3A Substrate, Midazolam, in Patients With ALK-Positive or ROS1-Positive Solid Tumors","Midazolam|Brigatinib","GABA Agonist|TK Inhibitor|ALK Inhibitor","Yes","['Midazolam']","No",null,"Phase 1",1,20,"Anticipated","2019-02-07","2019-06-15","AUC","Area Under The Curve",{"$nulls":3},"The purpose of this study is to characterize the effect of repeat-dose administration of brigatinib 180 milligram (mg) once daily (QD) on the single-dose pharmacokinetics (PK) of midazolam.","The study will enroll approximately 20 participants to achieve approximately 15 PK-evaluable participants for assessment. This study will consist of 2 parts: Part A of the study will evaluate the effect of repeat-dose administration of brigatinib on the single-dose PK of midazolam. Part B of the study is exploratory and will allow participants to continue brigatinib until disease progression (PD). All participants will receive study drug via the oral route. Participants will be assigned to: Midazolam 3 mg + Brigatinib 90 mg.\n\nThe overall time to participate in this study is 26 months. Participants will have a 28-day PK cycle in Part A and a maximum of 23 cycles in Part B, and a 30-day follow-up period after end of treatment.","A Phase 1 Drug-Drug Interaction Study Between Brigatinib and the CYP3A Substrate Midazolam in Patients With ALK-Positive or ROS1-Positive Solid Tumors","Brigatinib-1001","Carcinoma, Advanced ALK+ or ROS1+Non-Small-Cell Lung, Neoplasm, Advanced ALK+ or ROS1+Solid Tumors","Small Cell Lung Cancer|Noma|Carcinoma|Non-Small-Cell Lung Cancer|Small Cell Carcinoma","Oncology Solid Tumor|Mouth Diseases","Oncology|Ear, Nose and Throat","Experimental","Midazolam 3 mg + Brigatinib 90 mg","Midazolam 3 mg, orally, once on Day 1, followed by brigatinib 90 mg, orally, once daily on Days 2 to 8, further followed by brigatinib 180 mg, orally, once daily on Days 9 to 28 in Part A Cycle 1 (28 days treatment cycle). Participants escalating to brigatinib 180 mg once daily will also receive midazolam 3 mg, orally, once on Day 21 of Part A Cycle 1. After completion of Part A, participants will continue into Part B. Participants in Part B will receive brigatinib up to 180 mg (or at the highest tolerated dose in Part A), orally, once daily in a 28 day treatment cycle, up to a maximum of 23 cycles or until progression of disease, unacceptable toxicity, or another discontinuation criterion is met.","Drug","Midazolam|Brigatinib","Midazolam syrup.|Brigatinib tablets.","Alunbrig","Midazolam 3 mg + Brigatinib 90 mg","\n\n 1. Locally advanced or metastatic solid tumors who meet 1 of the following 4 criteria: * With locally advanced or metastatic ALK-positive NSCLC who have progressed on or are intolerant to treatment with at least 1 other ALK inhibitor.\n     * With ALK-positive nonlung solid tumors that are locally advanced or metastatic and for whom no standard, nonexperimental therapy is available.\n     * With locally advanced or metastatic ROS1-positive NSCLC who have progressed on crizotinib therapy or are intolerant to crizotinib, or\n     * With ROS1-positive nonlung solid tumors that are locally advanced or metastatic and for whom no standard, nonexperimental therapy is available.\n    \n    \n 2. Eastern cooperative Oncology Group (ECOG) performance status of 0 or 1.\n 3. Have at least 1 target lesion per response evaluation criteria in solid tumors (RECIST) version 1.1.\n 4. Have recovered from toxicities related to prior anticancer therapy to National Cancer Institute common terminology criteria for adverse events (NCI CTCAE) version 4.03 Grade less than or equal to (<=) 1.\n 5. Suitable venous access for study-required blood sampling (that is, including PK and laboratory safety tests).\n\n","\n\n 1. Systemic treatment with strong or moderate cytochrome P450 3A (CYP3A) inhibitors or inducers within 14 days before enrollment.\n 2. Prior therapy with brigatinib.\n 3. Received prior ALK-inhibitor therapy within 7 days before the first dose of study drug.\n 4. Treatment with any investigational systemic anticancer agents within 14 days or 5 half-lives, whichever is longer, before the first dose of study drug.\n 5. Received chemotherapy or radiation therapy within 14 days before the first dose of study drug, except for stereotactic radiosurgery (SRS) or stereotactic body radiation therapy.\n 6. Received antineoplastic monoclonal antibodies within 30 days before the first dose of study drug.\n 7. Had major surgery within 30 days before the first dose of study drug. Minor surgical procedures, such as catheter placement or minimally invasive biopsies, are allowed.\n 8. Have current spinal cord compression (symptomatic or asymptomatic and detected by radiographic imaging). Patients with leptomeningeal disease and without cord compression are allowed.",{"$nulls":4},"Actual","2018-02-05","Actual","Anticipated","2020-08-18","Anticipated","2019-02-01","2018-01-29","2018-01-29","2019-02-05","No","Drug therapy, brigatinib, lung cancer, ALK, ROS1","Interventional","Other","Sequential Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No","Yes\nTakeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/Approach for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.",{"$nulls":3},"Yes","No",{"$nulls":17},"U1111-1203-0166|2018-001624-19","WHO|EudraCT Number","Part A: AUCâˆž: Area Under the Plasma Concentration-Time Curve from Time 0 to Infinity (AUCâˆž) for Midazolam|Part A: Cmax: Maximum Observed Plasma Concentration for Midazolam|Part A: Tmax: Time to Reach the Maximum Observed Plasma Concentration (Cmax) for Midazolam","Days 1 and 21 pre-dose and at multiple time points (up to 24 hours) post-dose",{"$nulls":4},"GlobalOncologyMedinfo@takeda.com","Takeda Study Registration Call Center",-3933,"Paris, Ile-De-|Marseille Cedex 5, Provence Alpes Cote D'Azur, France, 13385 Hopital De La TimoneMarseille, Provence Alpes Cote D'Azur, France, 13005|Bologna, Italy, 40138 Ospedale San RaffaeleMilano, Italy, 20132 Istituto Europeo Di OncologiaMilano, Italy, 20141 Azienda Ospedaliero Universitaria Di ParmaParma, Italy, 43126 Ospedale Santa Maria Delle CrociRavenna, Italy, 48121|Aviano, Pordenone, Italy, 33081|Amsterdam, Noord-Holland, Netherlands, 1006 Cx|Barcelona, Spain, 08028 Hospital Universitari Vall D'HebronBarcelona, Spain, 08035 Hospital Universitario Ramon Y CajalMadrid, Spain, 28034 Hospital Universitario Fundacion Jimenez DiazMadrid, Spain, 28040 Hm Centro Integral Oncologico Clara CampalMadrid, Spain, 28050|Barakaldo, Vizcaya, Spain, 48903",null,"France|Italy|Netherlands|Spain","Groupe Hospitalier Bichat-Claude Bernard - Hopital Bichat|Provence Alpes Cote D'Azur Hopital De La Timone|Policlinico Sant'Orsola Malpighi|Pordenone Centro Di Riferimento Oncologico Di Aviano|Cancer Institute|Hospital Universitario Dexeus|Vizcaya Hospital Universitario Dexeus,",{"$nulls":3},"Medical Director","2019-02-05","2020-05-25T16:40:15.722","2020-05-26T17:10:42.972","NCT03420742"]
["5ecbf4ef307e3d1b1f8d9eac","NCT03420742","2019-03-04","Ariad","ARIA","Not yet recruiting","A Phase 1 Drug-Drug Interaction Study Between Brigatinib and the CYP3A Substrate, Midazolam, in Patients With ALK-Positive or ROS1-Positive Solid Tumors","Midazolam|Brigatinib","GABA Agonist|TK Inhibitor|ALK Inhibitor","Yes","['Midazolam']","No",null,"Phase 1",1,20,"Anticipated","2019-03-07","2019-06-15","AUC","Area Under The Curve",{"$nulls":3},"The purpose of this study is to characterize the effect of repeat-dose administration of brigatinib 180 milligram (mg) once daily (QD) on the single-dose pharmacokinetics (PK) of midazolam.","The study will enroll approximately 20 participants to achieve approximately 15 PK-evaluable participants for assessment. This study will consist of 2 parts: Part A of the study will evaluate the effect of repeat-dose administration of brigatinib on the single-dose PK of midazolam. Part B of the study is exploratory and will allow participants to continue brigatinib until disease progression (PD). All participants will receive study drug via the oral route. Participants will be assigned to: Midazolam 3 mg + Brigatinib 90 mg.\n\nThe overall time to participate in this study is 26 months. Participants will have a 28-day PK cycle in Part A and a maximum of 23 cycles in Part B, and a 30-day follow-up period after end of treatment.","A Phase 1 Drug-Drug Interaction Study Between Brigatinib and the CYP3A Substrate Midazolam in Patients With ALK-Positive or ROS1-Positive Solid Tumors","Brigatinib-1001","Carcinoma, Advanced ALK+ or ROS1+Non-Small-Cell Lung, Neoplasm, Advanced ALK+ or ROS1+Solid Tumors","Small Cell Lung Cancer|Noma|Carcinoma|Non-Small-Cell Lung Cancer|Small Cell Carcinoma","Oncology Solid Tumor|Mouth Diseases","Oncology|Ear, Nose and Throat","Experimental","Midazolam 3 mg + Brigatinib 90 mg","Midazolam 3 mg, orally, once on Day 1, followed by brigatinib 90 mg, orally, once daily on Days 2 to 8, further followed by brigatinib 180 mg, orally, once daily on Days 9 to 28 in Part A Cycle 1 (28 days treatment cycle). Participants escalating to brigatinib 180 mg once daily will also receive midazolam 3 mg, orally, once on Day 21 of Part A Cycle 1. After completion of Part A, participants will continue into Part B. Participants in Part B will receive brigatinib up to 180 mg (or at the highest tolerated dose in Part A), orally, once daily in a 28 day treatment cycle, up to a maximum of 23 cycles or until progression of disease, unacceptable toxicity, or another discontinuation criterion is met.","Drug","Midazolam|Brigatinib","Midazolam syrup.|Brigatinib tablets.","Alunbrig","Midazolam 3 mg + Brigatinib 90 mg","\n\n 1. Locally advanced or metastatic solid tumors who meet 1 of the following 4 criteria: * With locally advanced or metastatic ALK-positive NSCLC who have progressed on or are intolerant to treatment with at least 1 other ALK inhibitor.\n     * With ALK-positive nonlung solid tumors that are locally advanced or metastatic and for whom no standard, nonexperimental therapy is available.\n     * With locally advanced or metastatic ROS1-positive NSCLC who have progressed on crizotinib therapy or are intolerant to crizotinib, or\n     * With ROS1-positive nonlung solid tumors that are locally advanced or metastatic and for whom no standard, nonexperimental therapy is available.\n    \n    \n 2. Eastern cooperative Oncology Group (ECOG) performance status of 0 or 1.\n 3. Have at least 1 target lesion per response evaluation criteria in solid tumors (RECIST) version 1.1.\n 4. Have recovered from toxicities related to prior anticancer therapy to National Cancer Institute common terminology criteria for adverse events (NCI CTCAE) version 4.03 Grade less than or equal to (<=) 1.\n 5. Suitable venous access for study-required blood sampling (that is, including PK and laboratory safety tests).\n\n","\n\n 1. Systemic treatment with strong or moderate cytochrome P450 3A (CYP3A) inhibitors or inducers within 14 days before enrollment.\n 2. Prior therapy with brigatinib.\n 3. Received prior ALK-inhibitor therapy within 7 days before the first dose of study drug.\n 4. Treatment with any investigational systemic anticancer agents within 14 days or 5 half-lives, whichever is longer, before the first dose of study drug.\n 5. Received chemotherapy or radiation therapy within 14 days before the first dose of study drug, except for stereotactic radiosurgery (SRS) or stereotactic body radiation therapy.\n 6. Received antineoplastic monoclonal antibodies within 30 days before the first dose of study drug.\n 7. Had major surgery within 30 days before the first dose of study drug. Minor surgical procedures, such as catheter placement or minimally invasive biopsies, are allowed.\n 8. Have current spinal cord compression (symptomatic or asymptomatic and detected by radiographic imaging). Patients with leptomeningeal disease and without cord compression are allowed.",{"$nulls":4},"Actual","2018-02-05","Actual","Anticipated","2020-08-18","Anticipated","2019-02-01","2018-01-29","2018-01-29","2019-03-01","No","Drug therapy, brigatinib, lung cancer, ALK, ROS1","Interventional","Other","Sequential Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No","Yes\nTakeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/Approach for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.",{"$nulls":3},"Yes","No",{"$nulls":17},"U1111-1203-0166|2018-001624-19","WHO|EudraCT Number","Part A: AUCâˆž: Area Under the Plasma Concentration-Time Curve from Time 0 to Infinity (AUCâˆž) for Midazolam|Part A: Cmax: Maximum Observed Plasma Concentration for Midazolam|Part A: Tmax: Time to Reach the Maximum Observed Plasma Concentration (Cmax) for Midazolam","Days 1 and 21 pre-dose and at multiple time points (up to 24 hours) post-dose",{"$nulls":4},"GlobalOncologyMedinfo@takeda.com","Takeda Study Registration Call Center",-3933,"Paris, Ile-De-|Marseille Cedex 5, Provence Alpes Cote D'Azur, France, 13385 Hopital De La TimoneMarseille, Provence Alpes Cote D'Azur, France, 13005|Bologna, Italy, 40138 Policlinico Sant'Orsola MalpighiBologna, Italy, 40138 Ospedale San RaffaeleMilano, Italy, 20132 Istituto Europeo Di OncologiaMilano, Italy, 20141 Azienda Ospedaliero Universitaria Di ParmaParma, Italy, 43126 Ospedale Santa Maria Delle CrociRavenna, Italy, 48121|Aviano, Pordenone, Italy, 33081|Amsterdam, Noord-Holland, Netherlands, 1006 Cx|Barcelona, Spain, 08028 Hospital Universitario DexeusBarcelona, Spain, 08028 Hospital Universitari Vall D'HebronBarcelona, Spain, 08035 Hospital Universitario Ramon Y CajalMadrid, Spain, 28034 Hospital Universitario Fundacion Jimenez DiazMadrid, Spain, 28040 Hm Centro Integral Oncologico Clara CampalMadrid, Spain, 28050",null,"France|Italy|Netherlands|Spain","Groupe Hospitalier Bichat-Claude Bernard - Hopital Bichat|Provence Alpes Cote D'Azur Hopital De La Timone|Ospedale San Raffaele|Pordenone Centro Di Riferimento Oncologico Di Aviano|Cancer Institute|Hospital Universitario Dexeus,",{"$nulls":3},"Medical Director","2019-03-01","2020-05-25T16:40:15.868","2020-05-26T17:10:42.972","NCT03420742"]
["5ecbf4f011702c1b1b916c27","NCT03420742","2019-03-22","Ariad","ARIA","Not yet recruiting","A Phase 1 Drug-Drug Interaction Study Between Brigatinib and the CYP3A Substrate, Midazolam, in Patients With ALK-Positive or ROS1-Positive Solid Tumors","Midazolam|Brigatinib","GABA Agonist|TK Inhibitor|ALK Inhibitor","Yes","['Midazolam']","No",null,"Phase 1",1,20,"Anticipated","2019-03-28","2019-06-15","AUC","Area Under The Curve",{"$nulls":3},"The purpose of this study is to characterize the effect of repeat-dose administration of brigatinib 180 milligram (mg) once daily (QD) on the single-dose pharmacokinetics (PK) of midazolam.","The study will enroll approximately 20 participants to achieve approximately 15 PK-evaluable participants for assessment. This study will consist of 2 parts: Part A of the study will evaluate the effect of repeat-dose administration of brigatinib on the single-dose PK of midazolam. Part B of the study is exploratory and will allow participants to continue brigatinib until disease progression (PD). All participants will receive study drug via the oral route. Participants will be assigned to: Midazolam 3 mg + Brigatinib 90 mg.\n\nThe overall time to participate in this study is 26 months. Participants will have a 28-day PK cycle in Part A and a maximum of 23 cycles in Part B, and a 30-day follow-up period after end of treatment.","A Phase 1 Drug-Drug Interaction Study Between Brigatinib and the CYP3A Substrate Midazolam in Patients With ALK-Positive or ROS1-Positive Solid Tumors","Brigatinib-1001","Carcinoma, Advanced ALK+ or ROS1+Non-Small-Cell Lung, Neoplasm, Advanced ALK+ or ROS1+Solid Tumors","Small Cell Lung Cancer|Noma|Carcinoma|Non-Small-Cell Lung Cancer|Small Cell Carcinoma","Oncology Solid Tumor|Mouth Diseases","Oncology|Ear, Nose and Throat","Experimental","Midazolam 3 mg + Brigatinib 90 mg","Midazolam 3 mg, orally, once on Day 1, followed by brigatinib 90 mg, orally, once daily on Days 2 to 8, further followed by brigatinib 180 mg, orally, once daily on Days 9 to 28 in Part A Cycle 1 (28 days treatment cycle). Participants escalating to brigatinib 180 mg once daily will also receive midazolam 3 mg, orally, once on Day 21 of Part A Cycle 1. After completion of Part A, participants will continue into Part B. Participants in Part B will receive brigatinib up to 180 mg (or at the highest tolerated dose in Part A), orally, once daily in a 28 day treatment cycle, up to a maximum of 23 cycles or until progression of disease, unacceptable toxicity, or another discontinuation criterion is met.","Drug","Midazolam|Brigatinib","Midazolam syrup.|Brigatinib tablets.","Alunbrig","Midazolam 3 mg + Brigatinib 90 mg","\n\n 1. Locally advanced or metastatic solid tumors who meet 1 of the following 4 criteria: * With locally advanced or metastatic ALK-positive NSCLC who have progressed on or are intolerant to treatment with at least 1 other ALK inhibitor.\n     * With ALK-positive nonlung solid tumors that are locally advanced or metastatic and for whom no standard, nonexperimental therapy is available.\n     * With locally advanced or metastatic ROS1-positive NSCLC who have progressed on crizotinib therapy or are intolerant to crizotinib, or\n     * With ROS1-positive nonlung solid tumors that are locally advanced or metastatic and for whom no standard, nonexperimental therapy is available.\n    \n    \n 2. Eastern cooperative Oncology Group (ECOG) performance status of 0 or 1.\n 3. Have at least 1 target lesion per response evaluation criteria in solid tumors (RECIST) version 1.1.\n 4. Have recovered from toxicities related to prior anticancer therapy to National Cancer Institute common terminology criteria for adverse events (NCI CTCAE) version 4.03 Grade less than or equal to (<=) 1.\n 5. Suitable venous access for study-required blood sampling (that is, including PK and laboratory safety tests).\n\n","\n\n 1. Systemic treatment with strong or moderate cytochrome P450 3A (CYP3A) inhibitors or inducers within 14 days before enrollment.\n 2. Prior therapy with brigatinib.\n 3. Received prior ALK-inhibitor therapy within 7 days before the first dose of study drug.\n 4. Treatment with any investigational systemic anticancer agents within 14 days or 5 half-lives, whichever is longer, before the first dose of study drug.\n 5. Received chemotherapy or radiation therapy within 14 days before the first dose of study drug, except for stereotactic radiosurgery (SRS) or stereotactic body radiation therapy.\n 6. Received antineoplastic monoclonal antibodies within 30 days before the first dose of study drug.\n 7. Had major surgery within 30 days before the first dose of study drug. Minor surgical procedures, such as catheter placement or minimally invasive biopsies, are allowed.\n 8. Have current spinal cord compression (symptomatic or asymptomatic and detected by radiographic imaging). Patients with leptomeningeal disease and without cord compression are allowed.",{"$nulls":4},"Actual","2018-02-05","Actual","Anticipated","2020-08-18","Anticipated","2019-03-01","2018-01-29","2018-01-29","2019-03-20","No","Drug therapy, brigatinib, lung cancer, ALK, ROS1","Interventional","Other","Sequential Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No","Yes\nTakeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/Approach for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.",{"$nulls":3},"Yes","No",{"$nulls":17},"U1111-1203-0166|2018-001624-19","WHO|EudraCT Number","Part A: AUCâˆž: Area Under the Plasma Concentration-Time Curve from Time 0 to Infinity (AUCâˆž) for Midazolam|Part A: Cmax: Maximum Observed Plasma Concentration for Midazolam|Part A: Tmax: Time to Reach the Maximum Observed Plasma Concentration (Cmax) for Midazolam","Days 1 and 21 pre-dose and at multiple time points (up to 24 hours) post-dose",{"$nulls":4},"GlobalOncologyMedinfo@takeda.com","Takeda Study Registration Call Center",-3933,"Paris, Ile-De-|Marseille Cedex 5, Provence Alpes Cote D'Azur, France, 13385 Hopital De La TimoneMarseille, Provence Alpes Cote D'Azur, France, 13005|Bologna, Italy, 40138 Policlinico Sant'Orsola MalpighiBologna, Italy, 40138 Ospedale San RaffaeleMilano, Italy, 20132 Istituto Europeo Di OncologiaMilano, Italy, 20141 Azienda Ospedaliero Universitaria Di ParmaParma, Italy, 43126 Ospedale Santa Maria Delle CrociRavenna, Italy, 48121|Aviano, Pordenone, Italy, 33081|Amsterdam, Noord-Holland, Netherlands, 1006 Cx|Barcelona, Spain, 08028 Hospital Universitario DexeusBarcelona, Spain, 08028 Hospital Universitari Vall D'HebronBarcelona, Spain, 08035 Hospital Universitario Ramon Y CajalMadrid, Spain, 28034 Hospital Universitario Fundacion Jimenez DiazMadrid, Spain, 28040 Hm Centro Integral Oncologico Clara CampalMadrid, Spain, 28050",null,"France|Italy|Netherlands|Spain","Groupe Hospitalier Bichat-Claude Bernard - Hopital Bichat|Provence Alpes Cote D'Azur Hopital De La Timone|Ospedale San Raffaele|Pordenone Centro Di Riferimento Oncologico Di Aviano|Cancer Institute|Hospital Universitario Dexeus,",{"$nulls":3},"Medical Director","2019-03-20","2020-05-25T16:40:16.206","2020-05-26T17:10:42.972","NCT03420742"]
["5ecbf4effe30261b1a04841b","NCT03420742","2019-05-20","Ariad","ARIA","Not yet recruiting","A Phase 1 Drug-Drug Interaction Study Between Brigatinib and the CYP3A Substrate, Midazolam, in Patients With ALK-Positive or ROS1-Positive Solid Tumors","Midazolam|Brigatinib","GABA Agonist|TK Inhibitor|ALK Inhibitor","No",null,"No",null,"Phase 1",1,20,"Anticipated","2019-05-13","2020-04-06","AUC","Area Under The Curve",{"$nulls":3},"The purpose of this study is to characterize the effect of repeat-dose administration of brigatinib 180 milligram (mg) once daily (QD) on the single-dose pharmacokinetics (PK) of midazolam.","The study will enroll approximately 20 participants to achieve approximately 15 PK-evaluable participants for assessment. This study will consist of 2 parts: Part A of the study will evaluate the effect of repeat-dose administration of brigatinib on the single-dose PK of midazolam. Part B of the study is exploratory and will allow participants to continue brigatinib until disease progression (PD). All participants will receive study drug via the oral route. Participants will be assigned to: Midazolam 3 mg + Brigatinib 90 mg.\n\nThe overall time to participate in this study is 26 months. Participants will have a 28-day PK cycle in Part A and a maximum of 23 cycles in Part B, and a 30-day follow-up period after end of treatment.","A Phase 1 Drug-Drug Interaction Study Between Brigatinib and the CYP3A Substrate Midazolam in Patients With ALK-Positive or ROS1-Positive Solid Tumors","Brigatinib-1001","Carcinoma, Advanced ALK+ or ROS1+Non-Small-Cell Lung, Neoplasm, Advanced ALK+ or ROS1+Solid Tumors","Small Cell Lung Cancer|Noma|Carcinoma|Non-Small-Cell Lung Cancer|Small Cell Carcinoma","Oncology Solid Tumor|Mouth Diseases","Oncology|Ear, Nose and Throat","Experimental","Midazolam 3 mg + Brigatinib 90 mg","Midazolam 3 mg, orally, once on Day 1, followed by brigatinib 90 mg, orally, once daily on Days 2 to 8, further followed by brigatinib 180 mg, orally, once daily on Days 9 to 28 in Part A Cycle 1 (28 days treatment cycle). Participants escalating to brigatinib 180 mg once daily will also receive midazolam 3 mg, orally, once on Day 21 of Part A Cycle 1. After completion of Part A, participants will continue into Part B. Participants in Part B will receive brigatinib up to 180 mg (or at the highest tolerated dose in Part A), orally, once daily in a 28 day treatment cycle, up to a maximum of 23 cycles or until progression of disease, unacceptable toxicity, or another discontinuation criterion is met.","Drug","Midazolam|Brigatinib","Midazolam syrup.|Brigatinib tablets.","Alunbrig","Midazolam 3 mg + Brigatinib 90 mg","\n\n 1. Locally advanced or metastatic solid tumors who meet 1 of the following 4 criteria: * With locally advanced or metastatic ALK-positive NSCLC who have progressed on or are intolerant to treatment with at least 1 other ALK inhibitor.\n     * With ALK-positive nonlung solid tumors that are locally advanced or metastatic and for whom no standard, nonexperimental therapy is available.\n     * With locally advanced or metastatic ROS1-positive NSCLC who have progressed on crizotinib therapy or are intolerant to crizotinib, or\n     * With ROS1-positive nonlung solid tumors that are locally advanced or metastatic and for whom no standard, nonexperimental therapy is available.\n    \n    \n 2. Eastern cooperative Oncology Group (ECOG) performance status of 0 or 1.\n 3. Have at least 1 target lesion per response evaluation criteria in solid tumors (RECIST) version 1.1.\n 4. Have recovered from toxicities related to prior anticancer therapy to National Cancer Institute common terminology criteria for adverse events (NCI CTCAE) version 4.03 Grade less than or equal to (<=) 1.\n 5. Suitable venous access for study-required blood sampling (that is, including PK and laboratory safety tests).\n\n","\n\n 1. Systemic treatment with strong or moderate cytochrome P450 3A (CYP3A) inhibitors or inducers within 14 days before enrollment.\n 2. Prior therapy with brigatinib.\n 3. Received prior ALK-inhibitor therapy within 7 days before the first dose of study drug.\n 4. Treatment with any investigational systemic anticancer agents within 14 days or 5 half-lives, whichever is longer, before the first dose of study drug.\n 5. Received chemotherapy or radiation therapy within 14 days before the first dose of study drug, except for stereotactic radiosurgery (SRS) or stereotactic body radiation therapy.\n 6. Received antineoplastic monoclonal antibodies within 30 days before the first dose of study drug.\n 7. Had major surgery within 30 days before the first dose of study drug. Minor surgical procedures, such as catheter placement or minimally invasive biopsies, are allowed.\n 8. Have current spinal cord compression (symptomatic or asymptomatic and detected by radiographic imaging). Patients with leptomeningeal disease and without cord compression are allowed.",{"$nulls":4},"Actual","2018-02-05","Actual","Anticipated","2021-05-31","Anticipated","2019-05-01","2018-01-29","2018-01-29","2019-05-17","No","Drug therapy, brigatinib, lung cancer, ALK, ROS1","Interventional","Other","Sequential Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No","Yes\nTakeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/Approach for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.",{"$nulls":3},"Yes","No",{"$nulls":17},"U1111-1203-0166|2018-001624-19","WHO|EudraCT Number","Part A: AUCâˆž: Area Under the Plasma Concentration-Time Curve from Time 0 to Infinity (AUCâˆž) for Midazolam|Part A: Cmax: Maximum Observed Plasma Concentration for Midazolam|Part A: Tmax: Time to Reach the Maximum Observed Plasma Concentration (Cmax) for Midazolam","Days 1 and 21 pre-dose and at multiple time points (up to 24 hours) post-dose",{"$nulls":4},"GlobalOncologyMedinfo@takeda.com","Takeda Study Registration Call Center",-3933,"Paris, Ile-De-|Marseille Cedex 5, Provence Alpes Cote D'Azur, France, 13385 Hopital De La TimoneMarseille, Provence Alpes Cote D'Azur, France, 13005|Bologna, Italy, 40138 Policlinico Sant'Orsola MalpighiBologna, Italy, 40138 Ospedale San RaffaeleMilano, Italy, 20132 Istituto Europeo Di OncologiaMilano, Italy, 20141 Azienda Ospedaliero Universitaria Di ParmaParma, Italy, 43126 Ospedale Santa Maria Delle CrociRavenna, Italy, 48121|Aviano, Pordenone, Italy, 33081|Amsterdam, Noord-Holland, Netherlands, 1006 Cx|Barcelona, Spain, 08028 Hospital Universitario DexeusBarcelona, Spain, 08028 Hospital Universitari Vall D'HebronBarcelona, Spain, 08035 Hospital Universitario Ramon Y CajalMadrid, Spain, 28034 Hospital Universitario Fundacion Jimenez DiazMadrid, Spain, 28040 Hm Centro Integral Oncologico Clara CampalMadrid, Spain, 28050",null,"France|Italy|Netherlands|Spain","Groupe Hospitalier Bichat-Claude Bernard - Hopital Bichat|Provence Alpes Cote D'Azur Hopital De La Timone|Ospedale San Raffaele|Pordenone Centro Di Riferimento Oncologico Di Aviano|Cancer Institute|Hospital Universitario Dexeus,",{"$nulls":3},"Medical Director","2019-05-17","2020-05-25T16:40:15.982","2020-05-26T17:10:42.972","NCT03420742"]
["5ecbf4efe2561b1b11905f15","NCT03420742","2019-07-11","Ariad","ARIA","Recruiting","A Phase 1 Drug-Drug Interaction Study Between Brigatinib and the CYP3A Substrate, Midazolam, in Patients With ALK-Positive or ROS1-Positive Solid Tumors","Midazolam|Brigatinib","GABA Agonist|TK Inhibitor|ALK Inhibitor","No",null,"No",null,"Phase 1",1,20,"Anticipated","2019-06-26","2020-04-06","AUC","Area Under The Curve",{"$nulls":3},"The purpose of this study is to characterize the effect of repeat-dose administration of brigatinib 180 milligram (mg) once daily (QD) on the single-dose pharmacokinetics (PK) of midazolam.","The study will enroll approximately 20 participants to achieve approximately 15 PK-evaluable participants for assessment. This study will consist of 2 parts: Part A of the study will evaluate the effect of repeat-dose administration of brigatinib on the single-dose PK of midazolam. Part B of the study is exploratory and will allow participants to continue brigatinib until disease progression (PD). All participants will receive study drug via the oral route. Participants will be assigned to: Midazolam 3 mg + Brigatinib 90 mg.\n\nThe overall time to participate in this study is 26 months. Participants will have a 28-day PK cycle in Part A and a maximum of 23 cycles in Part B, and a 30-day follow-up period after end of treatment.","A Phase 1 Drug-Drug Interaction Study Between Brigatinib and the CYP3A Substrate Midazolam in Patients With ALK-Positive or ROS1-Positive Solid Tumors","Brigatinib-1001","Carcinoma, Advanced ALK+ or ROS1+Non-Small-Cell Lung, Neoplasm, Advanced ALK+ or ROS1+Solid Tumors","Small Cell Lung Cancer|Noma|Carcinoma|Non-Small-Cell Lung Cancer|Small Cell Carcinoma","Oncology Solid Tumor|Mouth Diseases","Oncology|Ear, Nose and Throat","Experimental","Midazolam 3 mg + Brigatinib 90 mg","Midazolam 3 mg, orally, once on Day 1, followed by brigatinib 90 mg, orally, once daily on Days 2 to 8, further followed by brigatinib 180 mg, orally, once daily on Days 9 to 28 in Part A Cycle 1 (28 days treatment cycle). Participants escalating to brigatinib 180 mg once daily will also receive midazolam 3 mg, orally, once on Day 21 of Part A Cycle 1. After completion of Part A, participants will continue into Part B. Participants in Part B will receive brigatinib up to 180 mg (or at the highest tolerated dose in Part A), orally, once daily in a 28 day treatment cycle, up to a maximum of 23 cycles or until progression of disease, unacceptable toxicity, or another discontinuation criterion is met.","Drug","Midazolam|Brigatinib","Midazolam syrup.|Brigatinib tablets.","Alunbrig","Midazolam 3 mg + Brigatinib 90 mg","\n\n 1. Locally advanced or metastatic solid tumors who meet 1 of the following 4 criteria: * With locally advanced or metastatic ALK-positive NSCLC who have progressed on or are intolerant to treatment with at least 1 other ALK inhibitor.\n     * With ALK-positive nonlung solid tumors that are locally advanced or metastatic and for whom no standard, nonexperimental therapy is available.\n     * With locally advanced or metastatic ROS1-positive NSCLC who have progressed on crizotinib therapy or are intolerant to crizotinib, or\n     * With ROS1-positive nonlung solid tumors that are locally advanced or metastatic and for whom no standard, nonexperimental therapy is available.\n    \n    \n 2. Eastern cooperative Oncology Group (ECOG) performance status of 0 or 1.\n 3. Have at least 1 target lesion per response evaluation criteria in solid tumors (RECIST) version 1.1.\n 4. Have recovered from toxicities related to prior anticancer therapy to National Cancer Institute common terminology criteria for adverse events (NCI CTCAE) version 4.03 Grade less than or equal to (<=) 1.\n 5. Suitable venous access for study-required blood sampling (that is, including PK and laboratory safety tests).\n\n","\n\n 1. Systemic treatment with strong or moderate cytochrome P450 3A (CYP3A) inhibitors or inducers within 14 days before enrollment.\n 2. Prior therapy with brigatinib.\n 3. Received prior ALK-inhibitor therapy within 7 days before the first dose of study drug.\n 4. Treatment with any investigational systemic anticancer agents within 14 days or 5 half-lives, whichever is longer, before the first dose of study drug.\n 5. Received chemotherapy or radiation therapy within 14 days before the first dose of study drug, except for stereotactic radiosurgery (SRS) or stereotactic body radiation therapy.\n 6. Received antineoplastic monoclonal antibodies within 30 days before the first dose of study drug.\n 7. Had major surgery within 30 days before the first dose of study drug. Minor surgical procedures, such as catheter placement or minimally invasive biopsies, are allowed.\n 8. Have current spinal cord compression (symptomatic or asymptomatic and detected by radiographic imaging). Patients with leptomeningeal disease and without cord compression are allowed.",{"$nulls":4},"Actual","2018-02-05","Actual","Anticipated","2021-05-31","Anticipated","2019-07-01","2018-01-29","2018-01-29","2019-07-10","No","Drug therapy, brigatinib, lung cancer, ALK, ROS1","Interventional","Other","Sequential Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No","Yes\nTakeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/Approach for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.",{"$nulls":3},"Yes","No",{"$nulls":17},"U1111-1203-0166|2018-001624-19","WHO|EudraCT Number","Part A: AUCâˆž: Area Under the Plasma Concentration-Time Curve from Time 0 to Infinity (AUCâˆž) for Midazolam|Part A: Cmax: Maximum Observed Plasma Concentration for Midazolam|Part A: Tmax: Time to Reach the Maximum Observed Plasma Concentration (Cmax) for Midazolam","Days 1 and 21 pre-dose and at multiple time points (up to 24 hours) post-dose",{"$nulls":4},"GlobalOncologyMedinfo@takeda.com","Takeda Study Registration Call Center",-3933,"Paris, Ile-De-|Marseille, Provence Alpes Cote D'Azur, France, 13005|Bologna, Italy, 40138 Ospedale San RaffaeleMilano, Italy, 20132 Istituto Europeo Di OncologiaMilano, Italy, 20141 Azienda Ospedaliero Universitaria Di ParmaParma, Italy, 43126 Ospedale Santa Maria Delle CrociRavenna, Italy, 48121|Aviano, Pordenone, Italy, 33081|Amsterdam, Noord-Holland, Netherlands, 1006 Cx|Barcelona, Spain, 08028 Hospital Universitari Vall D'HebronBarcelona, Spain, 08035 Hospital Universitario Ramon Y CajalMadrid, Spain, 28034 Hospital Universitario Fundacion Jimenez DiazMadrid, Spain, 28040 Hm Centro Integral Oncologico Clara CampalMadrid, Spain, 28050",null,"France|Italy|Netherlands|Spain","Groupe Hospitalier Bichat-Claude Bernard - Hopital Bichat|Provence Alpes Cote D'Azur Hopital De La Timone|Policlinico Sant'Orsola Malpighi|Pordenone Centro Di Riferimento Oncologico Di Aviano|Cancer Institute|Hospital Universitario Dexeus",{"$nulls":3},"Medical Director","2019-07-10","2020-05-25T16:40:15.975","2020-05-26T17:10:42.972","NCT03420742"]
["5ecbf4effeab101b15530a4a","NCT03420742","2019-07-31","Ariad","ARIA","Recruiting","A Phase 1 Drug-Drug Interaction Study Between Brigatinib and the CYP3A Substrate, Midazolam, in Patients With ALK-Positive or ROS1-Positive Solid Tumors","Midazolam|Brigatinib","GABA Agonist|TK Inhibitor|ALK Inhibitor","No",null,"No",null,"Phase 1",1,20,"Anticipated","2019-06-26","2020-04-06","AUC","Area Under The Curve",{"$nulls":3},"The purpose of this study is to characterize the effect of repeat-dose administration of brigatinib 180 milligram (mg) once daily (QD) on the single-dose pharmacokinetics (PK) of midazolam.","The study will enroll approximately 20 participants to achieve approximately 15 PK-evaluable participants for assessment. This study will consist of 2 parts: Part A of the study will evaluate the effect of repeat-dose administration of brigatinib on the single-dose PK of midazolam. Part B of the study is exploratory and will allow participants to continue brigatinib until disease progression (PD). All participants will receive study drug via the oral route. Participants will be assigned to: Midazolam 3 mg + Brigatinib 90 mg.\n\nThe overall time to participate in this study is 26 months. Participants will have a 28-day PK cycle in Part A and a maximum of 23 cycles in Part B, and a 30-day follow-up period after end of treatment.","A Phase 1 Drug-Drug Interaction Study Between Brigatinib and the CYP3A Substrate Midazolam in Patients With ALK-Positive or ROS1-Positive Solid Tumors","Brigatinib-1001","Carcinoma, Advanced ALK+ or ROS1+Non-Small-Cell Lung, Neoplasm, Advanced ALK+ or ROS1+Solid Tumors","Small Cell Lung Cancer|Noma|Carcinoma|Non-Small-Cell Lung Cancer|Small Cell Carcinoma","Oncology Solid Tumor|Mouth Diseases","Oncology|Ear, Nose and Throat","Experimental","Midazolam 3 mg + Brigatinib 90 mg","Midazolam 3 mg, orally, once on Day 1, followed by brigatinib 90 mg, orally, once daily on Days 2 to 8, further followed by brigatinib 180 mg, orally, once daily on Days 9 to 28 in Part A Cycle 1 (28 days treatment cycle). Participants escalating to brigatinib 180 mg once daily will also receive midazolam 3 mg, orally, once on Day 21 of Part A Cycle 1. After completion of Part A, participants will continue into Part B. Participants in Part B will receive brigatinib up to 180 mg (or at the highest tolerated dose in Part A), orally, once daily in a 28 day treatment cycle, up to a maximum of 23 cycles or until progression of disease, unacceptable toxicity, or another discontinuation criterion is met.","Drug","Midazolam|Brigatinib","Midazolam syrup.|Brigatinib tablets.","Alunbrig","Midazolam 3 mg + Brigatinib 90 mg","\n\n 1. Locally advanced or metastatic solid tumors who meet 1 of the following 4 criteria: * With locally advanced or metastatic ALK-positive NSCLC who have progressed on or are intolerant to treatment with at least 1 other ALK inhibitor.\n     * With ALK-positive nonlung solid tumors that are locally advanced or metastatic and for whom no standard, nonexperimental therapy is available.\n     * With locally advanced or metastatic ROS1-positive NSCLC who have progressed on crizotinib therapy or are intolerant to crizotinib, or\n     * With ROS1-positive nonlung solid tumors that are locally advanced or metastatic and for whom no standard, nonexperimental therapy is available.\n    \n    \n 2. Eastern cooperative Oncology Group (ECOG) performance status of 0 or 1.\n 3. Have at least 1 target lesion per response evaluation criteria in solid tumors (RECIST) version 1.1.\n 4. Have recovered from toxicities related to prior anticancer therapy to National Cancer Institute common terminology criteria for adverse events (NCI CTCAE) version 4.03 Grade less than or equal to (<=) 1.\n 5. Suitable venous access for study-required blood sampling (that is, including PK and laboratory safety tests).\n\n","\n\n 1. Systemic treatment with strong or moderate cytochrome P450 3A (CYP3A) inhibitors or inducers within 14 days before enrollment.\n 2. Prior therapy with brigatinib.\n 3. Received prior ALK-inhibitor therapy within 7 days before the first dose of study drug.\n 4. Treatment with any investigational systemic anticancer agents within 14 days or 5 half-lives, whichever is longer, before the first dose of study drug.\n 5. Received chemotherapy or radiation therapy within 14 days before the first dose of study drug, except for stereotactic radiosurgery (SRS) or stereotactic body radiation therapy.\n 6. Received antineoplastic monoclonal antibodies within 30 days before the first dose of study drug.\n 7. Had major surgery within 30 days before the first dose of study drug. Minor surgical procedures, such as catheter placement or minimally invasive biopsies, are allowed.\n 8. Have current spinal cord compression (symptomatic or asymptomatic and detected by radiographic imaging). Patients with leptomeningeal disease and without cord compression are allowed.",{"$nulls":4},"Actual","2018-02-05","Actual","Anticipated","2021-05-31","Anticipated","2019-07-01","2018-01-29","2018-01-29","2019-07-30","No","Drug therapy, brigatinib, lung cancer, ALK, ROS1","Interventional","Other","Sequential Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No","Yes\nTakeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/Approach for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.",{"$nulls":3},"Yes","No",{"$nulls":17},"U1111-1203-0166|2018-001624-19","WHO|EudraCT Number","Part A: AUCâˆž: Area Under the Plasma Concentration-Time Curve from Time 0 to Infinity (AUCâˆž) for Midazolam|Part A: Cmax: Maximum Observed Plasma Concentration for Midazolam|Part A: Tmax: Time to Reach the Maximum Observed Plasma Concentration (Cmax) for Midazolam","Days 1 and 21 pre-dose and at multiple time points (up to 24 hours) post-dose",{"$nulls":4},"GlobalOncologyMedinfo@takeda.com","Takeda Study Registration Call Center",-3933,"Paris, Ile-De-|Marseille, Provence Alpes Cote D'Azur, France, 13005|Bologna, Italy, 40138 Ospedale San RaffaeleMilano, Italy, 20132 Istituto Europeo Di OncologiaMilano, Italy, 20141 Azienda Ospedaliero Universitaria Di ParmaParma, Italy, 43126 Ospedale Santa Maria Delle CrociRavenna, Italy, 48121|Aviano, Pordenone, Italy, 33081|Amsterdam, Noord-Holland, Netherlands, 1006 Cx|Barcelona, Spain, 08028 Hospital Universitari Vall D'HebronBarcelona, Spain, 08035 Hospital Universitario Ramon Y CajalMadrid, Spain, 28034 Hospital Universitario Fundacion Jimenez DiazMadrid, Spain, 28040 Hm Centro Integral Oncologico Clara CampalMadrid, Spain, 28050",null,"France|Italy|Netherlands|Spain","Groupe Hospitalier Bichat-Claude Bernard - Hopital Bichat|Provence Alpes Cote D'Azur Hopital De La Timone|Policlinico Sant'Orsola Malpighi|Pordenone Centro Di Riferimento Oncologico Di Aviano|Cancer Institute|Hospital Universitario Dexeus",{"$nulls":3},"Medical Director","2019-07-30","2020-05-25T16:40:15.997","2020-05-26T17:10:42.972","NCT03420742"]
["5ecbf4f0e2561b1b11905f16","NCT03420742","2019-09-06","Ariad","ARIA","Recruiting","A Phase 1 Drug-Drug Interaction Study Between Brigatinib and the CYP3A Substrate, Midazolam, in Patients With ALK-Positive or ROS1-Positive Solid Tumors","Midazolam|Brigatinib","GABA Agonist|TK Inhibitor|ALK Inhibitor","No",null,"No",null,"Phase 1",1,20,"Anticipated","2019-06-26","2020-04-06","AUC","Area Under The Curve",{"$nulls":3},"The purpose of this study is to characterize the effect of repeat-dose administration of brigatinib 180 milligram (mg) once daily (QD) on the single-dose pharmacokinetics (PK) of midazolam.","The study will enroll approximately 20 participants to achieve approximately 15 PK-evaluable participants for assessment. This study will consist of 2 parts: Part A of the study will evaluate the effect of repeat-dose administration of brigatinib on the single-dose PK of midazolam. Part B of the study is exploratory and will allow participants to continue brigatinib until disease progression (PD). All participants will receive study drug via the oral route. Participants will be assigned to: Midazolam 3 mg + Brigatinib 90 mg.\n\nThe overall time to participate in this study is 26 months. Participants will have a 28-day PK cycle in Part A and a maximum of 23 cycles in Part B, and a 30-day follow-up period after end of treatment.","A Phase 1 Drug-Drug Interaction Study Between Brigatinib and the CYP3A Substrate Midazolam in Patients With ALK-Positive or ROS1-Positive Solid Tumors","Brigatinib-1001","Carcinoma, Advanced ALK+ or ROS1+Non-Small-Cell Lung, Neoplasm, Advanced ALK+ or ROS1+Solid Tumors","Small Cell Lung Cancer|Noma|Carcinoma|Non-Small-Cell Lung Cancer|Small Cell Carcinoma","Oncology Solid Tumor|Mouth Diseases","Oncology|Ear, Nose and Throat","Experimental","Midazolam 3 mg + Brigatinib 90 mg","Midazolam 3 mg, orally, once on Day 1, followed by brigatinib 90 mg, orally, once daily on Days 2 to 8, further followed by brigatinib 180 mg, orally, once daily on Days 9 to 28 in Part A Cycle 1 (28 days treatment cycle). Participants escalating to brigatinib 180 mg once daily will also receive midazolam 3 mg, orally, once on Day 21 of Part A Cycle 1. After completion of Part A, participants will continue into Part B. Participants in Part B will receive brigatinib up to 180 mg (or at the highest tolerated dose in Part A), orally, once daily in a 28 day treatment cycle, up to a maximum of 23 cycles or until progression of disease, unacceptable toxicity, or another discontinuation criterion is met.","Drug","Midazolam|Brigatinib","Midazolam syrup.|Brigatinib tablets.","Alunbrig","Midazolam 3 mg + Brigatinib 90 mg","\n\n 1. Locally advanced or metastatic solid tumors who meet 1 of the following 4 criteria: * With locally advanced or metastatic ALK-positive NSCLC who have progressed on or are intolerant to treatment with at least 1 other ALK inhibitor.\n     * With ALK-positive nonlung solid tumors that are locally advanced or metastatic and for whom no standard, nonexperimental therapy is available.\n     * With locally advanced or metastatic ROS1-positive NSCLC who have progressed on crizotinib therapy or are intolerant to crizotinib, or\n     * With ROS1-positive nonlung solid tumors that are locally advanced or metastatic and for whom no standard, nonexperimental therapy is available.\n    \n    \n 2. Eastern cooperative Oncology Group (ECOG) performance status of 0 or 1.\n 3. Have at least 1 target lesion per response evaluation criteria in solid tumors (RECIST) version 1.1.\n 4. Have recovered from toxicities related to prior anticancer therapy to National Cancer Institute common terminology criteria for adverse events (NCI CTCAE) version 4.03 Grade less than or equal to (<=) 1.\n 5. Suitable venous access for study-required blood sampling (that is, including PK and laboratory safety tests).\n\n","\n\n 1. Systemic treatment with strong or moderate cytochrome P450 3A (CYP3A) inhibitors or inducers within 14 days before enrollment.\n 2. Prior therapy with brigatinib.\n 3. Received prior ALK-inhibitor therapy within 7 days before the first dose of study drug.\n 4. Treatment with any investigational systemic anticancer agents within 14 days or 5 half-lives, whichever is longer, before the first dose of study drug.\n 5. Received chemotherapy or radiation therapy within 14 days before the first dose of study drug, except for stereotactic radiosurgery (SRS) or stereotactic body radiation therapy.\n 6. Received antineoplastic monoclonal antibodies within 30 days before the first dose of study drug.\n 7. Had major surgery within 30 days before the first dose of study drug. Minor surgical procedures, such as catheter placement or minimally invasive biopsies, are allowed.\n 8. Have current spinal cord compression (symptomatic or asymptomatic and detected by radiographic imaging). Patients with leptomeningeal disease and without cord compression are allowed.",{"$nulls":4},"Actual","2018-02-05","Actual","Anticipated","2021-05-31","Anticipated","2019-09-01","2018-01-29","2018-01-29","2019-09-05","No","Drug therapy, brigatinib, lung cancer, ALK, ROS1","Interventional","Other","Sequential Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No","Yes\nTakeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/Approach for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.",{"$nulls":3},"Yes","No",{"$nulls":17},"U1111-1203-0166|2018-001624-19","WHO|EudraCT Number","Part A: AUCâˆž: Area Under the Plasma Concentration-Time Curve from Time 0 to Infinity (AUCâˆž) for Midazolam|Part A: Cmax: Maximum Observed Plasma Concentration for Midazolam|Part A: Tmax: Time to Reach the Maximum Observed Plasma Concentration (Cmax) for Midazolam","Days 1 and 21 pre-dose and at multiple time points (up to 24 hours) post-dose",{"$nulls":4},"GlobalOncologyMedinfo@takeda.com","Takeda Study Registration Call Center",-3933,"Paris, Ile-De-|Marseille, Provence Alpes Cote D'Azur, France, 13005|Bologna, Italy, 40138 Ospedale San RaffaeleMilano, Italy, 20132 Istituto Europeo Di OncologiaMilano, Italy, 20141 Azienda Ospedaliero Universitaria Di ParmaParma, Italy, 43126 Ospedale Santa Maria Delle CrociRavenna, Italy, 48121|Aviano, Pordenone, Italy, 33081|Amsterdam, Noord-Holland, Netherlands, 1006 Cx|Barcelona, Spain, 08028 Hospital Universitari Vall D'HebronBarcelona, Spain, 08035 Hospital Universitario Ramon Y CajalMadrid, Spain, 28034 Hospital Universitario Fundacion Jimenez DiazMadrid, Spain, 28040 Hm Centro Integral Oncologico Clara CampalMadrid, Spain, 28050",null,"France|Italy|Netherlands|Spain","Groupe Hospitalier Bichat-Claude Bernard - Hopital Bichat|Provence Alpes Cote D'Azur Hopital De La Timone|Policlinico Sant'Orsola Malpighi|Pordenone Centro Di Riferimento Oncologico Di Aviano|Cancer Institute|Hospital Universitario Dexeus",{"$nulls":3},"Medical Director","2019-09-05","2020-05-25T16:40:16.834","2020-05-26T17:10:42.972","NCT03420742"]
["5ecbf4f0fe30261b1a04841c","NCT03420742","2019-10-07","Ariad","ARIA","Recruiting","A Phase 1 Drug-Drug Interaction Study Between Brigatinib and the CYP3A Substrate, Midazolam, in Patients With ALK-Positive or ROS1-Positive Solid Tumors","Midazolam|Brigatinib","GABA Agonist|TK Inhibitor|ALK Inhibitor","No",null,"No",null,"Phase 1",1,20,"Anticipated","2019-06-26","2020-04-06","AUC","Area Under The Curve",{"$nulls":3},"The purpose of this study is to characterize the effect of repeat-dose administration of brigatinib 180 milligram (mg) once daily (QD) on the single-dose pharmacokinetics (PK) of midazolam.","The study will enroll approximately 20 participants to achieve approximately 15 PK-evaluable participants for assessment. This study will consist of 2 parts: Part A of the study will evaluate the effect of repeat-dose administration of brigatinib on the single-dose PK of midazolam. Part B of the study is exploratory and will allow participants to continue brigatinib until disease progression (PD). All participants will receive study drug via the oral route. Participants will be assigned to: Midazolam 3 mg + Brigatinib 90 mg.\n\nThe overall time to participate in this study is 26 months. Participants will have a 28-day PK cycle in Part A and a maximum of 23 cycles in Part B, and a 30-day follow-up period after end of treatment.","A Phase 1 Drug-Drug Interaction Study Between Brigatinib and the CYP3A Substrate Midazolam in Patients With ALK-Positive or ROS1-Positive Solid Tumors","Brigatinib-1001","Carcinoma, Advanced ALK+ or ROS1+Non-Small-Cell Lung, Neoplasm, Advanced ALK+ or ROS1+Solid Tumors","Small Cell Lung Cancer|Noma|Carcinoma|Non-Small-Cell Lung Cancer|Small Cell Carcinoma","Oncology Solid Tumor|Mouth Diseases","Oncology|Ear, Nose and Throat","Experimental","Midazolam 3 mg + Brigatinib 90 mg","Midazolam 3 mg, orally, once on Day 1, followed by brigatinib 90 mg, orally, once daily on Days 2 to 8, further followed by brigatinib 180 mg, orally, once daily on Days 9 to 28 in Part A Cycle 1 (28 days treatment cycle). Participants escalating to brigatinib 180 mg once daily will also receive midazolam 3 mg, orally, once on Day 21 of Part A Cycle 1. After completion of Part A, participants will continue into Part B. Participants in Part B will receive brigatinib up to 180 mg (or at the highest tolerated dose in Part A), orally, once daily in a 28 day treatment cycle, up to a maximum of 23 cycles or until progression of disease, unacceptable toxicity, or another discontinuation criterion is met.","Drug","Midazolam|Brigatinib","Midazolam syrup.|Brigatinib tablets.","Alunbrig","Midazolam 3 mg + Brigatinib 90 mg","\n\n 1. Locally advanced or metastatic solid tumors who meet 1 of the following 4 criteria: * With locally advanced or metastatic ALK-positive NSCLC who have progressed on or are intolerant to treatment with at least 1 other ALK inhibitor.\n     * With ALK-positive nonlung solid tumors that are locally advanced or metastatic and for whom no standard, nonexperimental therapy is available.\n     * With locally advanced or metastatic ROS1-positive NSCLC who have progressed on crizotinib therapy or are intolerant to crizotinib, or\n     * With ROS1-positive nonlung solid tumors that are locally advanced or metastatic and for whom no standard, nonexperimental therapy is available.\n    \n    \n 2. Eastern cooperative Oncology Group (ECOG) performance status of 0 or 1.\n 3. Have at least 1 target lesion per response evaluation criteria in solid tumors (RECIST) version 1.1.\n 4. Have recovered from toxicities related to prior anticancer therapy to National Cancer Institute common terminology criteria for adverse events (NCI CTCAE) version 4.03 Grade less than or equal to (<=) 1.\n 5. Suitable venous access for study-required blood sampling (that is, including PK and laboratory safety tests).\n\n","\n\n 1. Systemic treatment with strong or moderate cytochrome P450 3A (CYP3A) inhibitors or inducers within 14 days before enrollment.\n 2. Prior therapy with brigatinib.\n 3. Received prior ALK-inhibitor therapy within 7 days before the first dose of study drug.\n 4. Treatment with any investigational systemic anticancer agents within 14 days or 5 half-lives, whichever is longer, before the first dose of study drug.\n 5. Received chemotherapy or radiation therapy within 14 days before the first dose of study drug, except for stereotactic radiosurgery (SRS) or stereotactic body radiation therapy.\n 6. Received antineoplastic monoclonal antibodies within 30 days before the first dose of study drug.\n 7. Had major surgery within 30 days before the first dose of study drug. Minor surgical procedures, such as catheter placement or minimally invasive biopsies, are allowed.\n 8. Have current spinal cord compression (symptomatic or asymptomatic and detected by radiographic imaging). Patients with leptomeningeal disease and without cord compression are allowed.",{"$nulls":4},"Actual","2018-02-05","Actual","Anticipated","2021-05-31","Anticipated","2019-10-01","2018-01-29","2018-01-29","2019-10-03","No","Drug therapy, brigatinib, lung cancer, ALK, ROS1","Interventional","Other","Sequential Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No","Yes\nTakeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.",{"$nulls":3},"Yes","No",{"$nulls":17},"U1111-1203-0166|2018-001624-19","WHO|EudraCT Number","Part A: AUCâˆž: Area Under the Plasma Concentration-Time Curve from Time 0 to Infinity (AUCâˆž) for Midazolam|Part A: Cmax: Maximum Observed Plasma Concentration for Midazolam|Part A: Tmax: Time to Reach the Maximum Observed Plasma Concentration (Cmax) for Midazolam","Days 1 and 21 pre-dose and at multiple time points (up to 24 hours) post-dose",{"$nulls":4},"GlobalOncologyMedinfo@takeda.com","Takeda Study Registration Call Center",-3933,"Paris, Ile-De-|Marseille, Provence Alpes Cote D'Azur, France, 13005|Bologna, Italy, 40138 Ospedale San RaffaeleMilano, Italy, 20132 Istituto Europeo Di OncologiaMilano, Italy, 20141 Azienda Ospedaliero Universitaria Di ParmaParma, Italy, 43126 Ospedale Santa Maria Delle CrociRavenna, Italy, 48121|Aviano, Pordenone, Italy, 33081|Amsterdam, Noord-Holland, Netherlands, 1066 Cx|Barcelona, Spain, 08028 Hospital Universitari Vall D'HebronBarcelona, Spain, 08035 Hospital Universitario Ramon Y CajalMadrid, Spain, 28034 Hospital Universitario Fundacion Jimenez DiazMadrid, Spain, 28040 Hm Centro Integral Oncologico Clara CampalMadrid, Spain, 28050",null,"France|Italy|Netherlands|Spain","Groupe Hospitalier Bichat-Claude Bernard - Hopital Bichat|Provence Alpes Cote D'Azur Hopital De La Timone|Policlinico Sant'Orsola Malpighi|Pordenone Centro Di Riferimento Oncologico Di Aviano|Cancer Institute|Hospital Universitario Dexeus",{"$nulls":3},"Medical Director","2019-10-03","2020-05-25T16:40:16.846","2020-05-26T17:10:42.972","NCT03420742"]
["5ecbf4f0feab101b15530a4b","NCT03420742","2019-11-08","Ariad","ARIA","Recruiting","A Phase 1 Drug-Drug Interaction Study Between Brigatinib and the CYP3A Substrate, Midazolam, in Patients With ALK-Positive or ROS1-Positive Solid Tumors","Midazolam|Brigatinib","GABA Agonist|TK Inhibitor|ALK Inhibitor","No",null,"No",null,"Phase 1",1,20,"Anticipated","2019-06-26","2020-04-06","AUC","Area Under The Curve",{"$nulls":3},"The purpose of this study is to characterize the effect of repeat-dose administration of brigatinib 180 milligram (mg) once daily (QD) on the single-dose pharmacokinetics (PK) of midazolam.","The study will enroll approximately 20 participants to achieve approximately 15 PK-evaluable participants for assessment. This study will consist of 2 parts: Part A of the study will evaluate the effect of repeat-dose administration of brigatinib on the single-dose PK of midazolam. Part B of the study is exploratory and will allow participants to continue brigatinib until disease progression (PD). All participants will receive study drug via the oral route. Participants will be assigned to: Midazolam 3 mg + Brigatinib 90 mg.\n\nThe overall time to participate in this study is 26 months. Participants will have a 28-day PK cycle in Part A and a maximum of 23 cycles in Part B, and a 30-day follow-up period after end of treatment.","A Phase 1 Drug-Drug Interaction Study Between Brigatinib and the CYP3A Substrate Midazolam in Patients With ALK-Positive or ROS1-Positive Solid Tumors","Brigatinib-1001","Carcinoma, Advanced ALK+ or ROS1+Non-Small-Cell Lung, Neoplasm, Advanced ALK+ or ROS1+Solid Tumors","Small Cell Lung Cancer|Noma|Carcinoma|Non-Small-Cell Lung Cancer|Small Cell Carcinoma","Oncology Solid Tumor|Mouth Diseases","Oncology|Ear, Nose and Throat","Experimental","Midazolam 3 mg + Brigatinib 90 mg","Midazolam 3 mg, orally, once on Day 1, followed by brigatinib 90 mg, orally, once daily on Days 2 to 8, further followed by brigatinib 180 mg, orally, once daily on Days 9 to 28 in Part A Cycle 1 (28 days treatment cycle). Participants escalating to brigatinib 180 mg once daily will also receive midazolam 3 mg, orally, once on Day 21 of Part A Cycle 1. After completion of Part A, participants will continue into Part B. Participants in Part B will receive brigatinib up to 180 mg (or at the highest tolerated dose in Part A), orally, once daily in a 28 day treatment cycle, up to a maximum of 23 cycles or until progression of disease, unacceptable toxicity, or another discontinuation criterion is met.","Drug","Midazolam|Brigatinib","Midazolam syrup.|Brigatinib tablets.","Alunbrig","Midazolam 3 mg + Brigatinib 90 mg","\n\n 1. Locally advanced or metastatic solid tumors who meet 1 of the following 4 criteria: * With locally advanced or metastatic ALK-positive NSCLC who have progressed on or are intolerant to treatment with at least 1 other ALK inhibitor.\n     * With ALK-positive nonlung solid tumors that are locally advanced or metastatic and for whom no standard, nonexperimental therapy is available.\n     * With locally advanced or metastatic ROS1-positive NSCLC who have progressed on crizotinib therapy or are intolerant to crizotinib, or\n     * With ROS1-positive nonlung solid tumors that are locally advanced or metastatic and for whom no standard, nonexperimental therapy is available.\n    \n    \n 2. Eastern cooperative Oncology Group (ECOG) performance status of 0 or 1.\n 3. Have at least 1 target lesion per response evaluation criteria in solid tumors (RECIST) version 1.1.\n 4. Have recovered from toxicities related to prior anticancer therapy to National Cancer Institute common terminology criteria for adverse events (NCI CTCAE) version 4.03 Grade less than or equal to (<=) 1.\n 5. Suitable venous access for study-required blood sampling (that is, including PK and laboratory safety tests).\n\n","\n\n 1. Systemic treatment with strong or moderate cytochrome P450 3A (CYP3A) inhibitors or inducers within 14 days before enrollment.\n 2. Prior therapy with brigatinib.\n 3. Received prior ALK-inhibitor therapy within 7 days before the first dose of study drug.\n 4. Treatment with any investigational systemic anticancer agents within 14 days or 5 half-lives, whichever is longer, before the first dose of study drug.\n 5. Received chemotherapy or radiation therapy within 14 days before the first dose of study drug, except for stereotactic radiosurgery (SRS) or stereotactic body radiation therapy.\n 6. Received antineoplastic monoclonal antibodies within 30 days before the first dose of study drug.\n 7. Had major surgery within 30 days before the first dose of study drug. Minor surgical procedures, such as catheter placement or minimally invasive biopsies, are allowed.\n 8. Have current spinal cord compression (symptomatic or asymptomatic and detected by radiographic imaging). Patients with leptomeningeal disease and without cord compression are allowed.",{"$nulls":4},"Actual","2018-02-05","Actual","Anticipated","2021-05-31","Anticipated","2019-11-01","2018-01-29","2018-01-29","2019-11-07","No","Drug therapy, brigatinib, lung cancer, ALK, ROS1","Interventional","Other","Sequential Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No","Yes\nTakeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.",{"$nulls":3},"Yes","No",{"$nulls":17},"U1111-1203-0166|2018-001624-19","WHO|EudraCT Number","Part A: AUCâˆž: Area Under the Plasma Concentration-Time Curve from Time 0 to Infinity (AUCâˆž) for Midazolam|Part A: Cmax: Maximum Observed Plasma Concentration for Midazolam|Part A: Tmax: Time to Reach the Maximum Observed Plasma Concentration (Cmax) for Midazolam","Days 1 and 21 pre-dose and at multiple time points (up to 24 hours) post-dose",{"$nulls":4},"GlobalOncologyMedinfo@takeda.com","Takeda Study Registration Call Center",-3933,"Paris, Ile-De-|Marseille, Provence Alpes Cote D'Azur, France, 13005|Bologna, Italy, 40138 Ospedale San RaffaeleMilano, Italy, 20132 Istituto Europeo Di OncologiaMilano, Italy, 20141 Azienda Ospedaliero Universitaria Di ParmaParma, Italy, 43126 Ospedale Santa Maria Delle CrociRavenna, Italy, 48121|Aviano, Pordenone, Italy, 33081|Amsterdam, Noord-Holland, Netherlands, 1066 Cx|Barcelona, Spain, 08028 Hospital Universitari Vall D'HebronBarcelona, Spain, 08035 Hospital Universitario Ramon Y CajalMadrid, Spain, 28034 Hospital Universitario Fundacion Jimenez DiazMadrid, Spain, 28040 Hm Centro Integral Oncologico Clara CampalMadrid, Spain, 28050",null,"France|Italy|Netherlands|Spain","Groupe Hospitalier Bichat-Claude Bernard - Hopital Bichat|Provence Alpes Cote D'Azur Hopital De La Timone|Policlinico Sant'Orsola Malpighi|Pordenone Centro Di Riferimento Oncologico Di Aviano|Cancer Institute|Hospital Universitario Dexeus",{"$nulls":3},"Medical Director","2019-11-07","2020-05-25T16:40:16.559","2020-05-26T17:10:42.972","NCT03420742"]
["5ecbf4f0307e3d1b1f8d9ead","NCT03420742","2020-03-27","Ariad","ARIA","Active, not recruiting","A Phase 1 Drug-Drug Interaction Study Between Brigatinib and the CYP3A Substrate, Midazolam, in Patients With ALK-Positive or ROS1-Positive Solid Tumors","Midazolam|Brigatinib","GABA Agonist|TK Inhibitor|ALK Inhibitor","No",null,"No",null,"Phase 1",1,24,"Actual","2019-06-26","2020-04-06","AUC","Area Under The Curve",{"$nulls":3},"The purpose of this study is to characterize the effect of repeat-dose administration of brigatinib 180 milligram (mg) once daily (QD) on the single-dose pharmacokinetics (PK) of midazolam.","The study will enroll approximately 20 participants to achieve approximately 15 PK-evaluable participants for assessment. This study will consist of 2 parts: Part A of the study will evaluate the effect of repeat-dose administration of brigatinib on the single-dose PK of midazolam. Part B of the study is exploratory and will allow participants to continue brigatinib until disease progression (PD). All participants will receive study drug via the oral route. Participants will be assigned to: Midazolam 3 mg + Brigatinib 90 mg.\n\nThe overall time to participate in this study is 26 months. Participants will have a 28-day PK cycle in Part A and a maximum of 23 cycles in Part B, and a 30-day follow-up period after end of treatment.","A Phase 1 Drug-Drug Interaction Study Between Brigatinib and the CYP3A Substrate Midazolam in Patients With ALK-Positive or ROS1-Positive Solid Tumors","Brigatinib-1001","Carcinoma, Advanced ALK+ or ROS1+Non-Small-Cell Lung, Neoplasm, Advanced ALK+ or ROS1+Solid Tumors","Small Cell Lung Cancer|Noma|Carcinoma|Non-Small-Cell Lung Cancer|Small Cell Carcinoma","Oncology Solid Tumor|Mouth Diseases","Oncology|Ear, Nose and Throat","Experimental","Midazolam 3 mg + Brigatinib 90 mg","Midazolam 3 mg, orally, once on Day 1, followed by brigatinib 90 mg, orally, once daily on Days 2 to 8, further followed by brigatinib 180 mg, orally, once daily on Days 9 to 28 in Part A Cycle 1 (28 days treatment cycle). Participants escalating to brigatinib 180 mg once daily will also receive midazolam 3 mg, orally, once on Day 21 of Part A Cycle 1. After completion of Part A, participants will continue into Part B. Participants in Part B will receive brigatinib up to 180 mg (or at the highest tolerated dose in Part A), orally, once daily in a 28 day treatment cycle, up to a maximum of 23 cycles or until progression of disease, unacceptable toxicity, or another discontinuation criterion is met.","Drug","Midazolam|Brigatinib","Midazolam syrup.|Brigatinib tablets.","Alunbrig","Midazolam 3 mg + Brigatinib 90 mg","\n\n 1. Locally advanced or metastatic solid tumors who meet 1 of the following 4 criteria: * With locally advanced or metastatic ALK-positive NSCLC who have progressed on or are intolerant to treatment with at least 1 other ALK inhibitor.\n     * With ALK-positive nonlung solid tumors that are locally advanced or metastatic and for whom no standard, nonexperimental therapy is available.\n     * With locally advanced or metastatic ROS1-positive NSCLC who have progressed on crizotinib therapy or are intolerant to crizotinib, or\n     * With ROS1-positive nonlung solid tumors that are locally advanced or metastatic and for whom no standard, nonexperimental therapy is available.\n    \n    \n 2. Eastern cooperative Oncology Group (ECOG) performance status of 0 or 1.\n 3. Have at least 1 target lesion per response evaluation criteria in solid tumors (RECIST) version 1.1.\n 4. Have recovered from toxicities related to prior anticancer therapy to National Cancer Institute common terminology criteria for adverse events (NCI CTCAE) version 4.03 Grade less than or equal to (<=) 1.\n 5. Suitable venous access for study-required blood sampling (that is, including PK and laboratory safety tests).\n\n","\n\n 1. Systemic treatment with strong or moderate cytochrome P450 3A (CYP3A) inhibitors or inducers within 14 days before enrollment.\n 2. Prior therapy with brigatinib.\n 3. Received prior ALK-inhibitor therapy within 7 days before the first dose of study drug.\n 4. Treatment with any investigational systemic anticancer agents within 14 days or 5 half-lives, whichever is longer, before the first dose of study drug.\n 5. Received chemotherapy or radiation therapy within 14 days before the first dose of study drug, except for stereotactic radiosurgery (SRS) or stereotactic body radiation therapy.\n 6. Received antineoplastic monoclonal antibodies within 30 days before the first dose of study drug.\n 7. Had major surgery within 30 days before the first dose of study drug. Minor surgical procedures, such as catheter placement or minimally invasive biopsies, are allowed.\n 8. Have current spinal cord compression (symptomatic or asymptomatic and detected by radiographic imaging). Patients with leptomeningeal disease and without cord compression are allowed.",{"$nulls":4},"Actual","2018-02-05","Actual","Anticipated","2021-05-31","Anticipated","2020-03-01","2018-01-29","2018-01-29","2020-03-26","No","Drug therapy, brigatinib, lung cancer, ALK, ROS1","Interventional","Other","Sequential Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No","Yes\nTakeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.",{"$nulls":3},"Yes","No",{"$nulls":17},"U1111-1203-0166|2018-001624-19","WHO|EudraCT Number","Part A: AUCâˆž: Area Under the Plasma Concentration-Time Curve from Time 0 to Infinity (AUCâˆž) for Midazolam|Part A: Cmax: Maximum Observed Plasma Concentration for Midazolam|Part A: Tmax: Time to Reach the Maximum Observed Plasma Concentration (Cmax) for Midazolam","Days 1 and 21 pre-dose and at multiple time points (up to 24 hours) post-dose",{"$nulls":7},"Paris, Ile-De-|Marseille, Provence Alpes Cote D'Azur, France, 13005|Bologna, Italy, 40138 Ospedale San RaffaeleMilano, Italy, 20132 Istituto Europeo Di OncologiaMilano, Italy, 20141 Azienda Ospedaliero Universitaria Di ParmaParma, Italy, 43126 Ospedale Santa Maria Delle CrociRavenna, Italy, 48121|Aviano, Pordenone, Italy, 33081|Amsterdam, Noord-Holland, Netherlands, 1066 Cx|Barcelona, Spain, 8028 Hospital Universitari Vall D'HebronBarcelona, Spain, 8035 Hospital Universitario Ramon Y CajalMadrid, Spain, 28034 Hospital Universitario Fundacion Jimenez DiazMadrid, Spain, 28040 Hm Centro Integral Oncologico Clara CampalMadrid, Spain, 28050",null,"France|Italy|Netherlands|Spain","Groupe Hospitalier Bichat-Claude Bernard - Hopital Bichat|Provence Alpes Cote D'Azur Hopital De La Timone|Policlinico Sant'Orsola Malpighi|Pordenone Centro Di Riferimento Oncologico Di Aviano|Cancer Institute|Hospital Universitario Dexeus",{"$nulls":3},"Medical Director","2020-03-26","2020-05-25T16:40:16.525","2020-05-26T17:10:42.972","NCT03420742"]
["5ecbf4f011702c1b1b916c28","NCT03420742","2020-05-13","Ariad","ARIA","Active, not recruiting","A Phase 1 Drug-Drug Interaction Study Between Brigatinib and the CYP3A Substrate, Midazolam, in Patients With ALK-Positive or ROS1-Positive Solid Tumors","Midazolam|Brigatinib","GABA Agonist|TK Inhibitor|ALK Inhibitor","No",null,"No",null,"Phase 1",1,24,"Actual","2019-06-26","2020-03-25","AUC","Area Under The Curve",{"$nulls":3},"The purpose of this study is to characterize the effect of repeat-dose administration of brigatinib 180 milligram (mg) once daily (QD) on the single-dose pharmacokinetics (PK) of midazolam.","The study will enroll approximately 20 participants to achieve approximately 15 PK-evaluable participants for assessment. This study will consist of 2 parts: Part A of the study will evaluate the effect of repeat-dose administration of brigatinib on the single-dose PK of midazolam. Part B of the study is exploratory and will allow participants to continue brigatinib until disease progression (PD). All participants will receive study drug via the oral route. Participants will be assigned to: Midazolam 3 mg + Brigatinib 90 mg.\n\nThe overall time to participate in this study is 26 months. Participants will have a 28-day PK cycle in Part A and a maximum of 23 cycles in Part B, and a 30-day follow-up period after end of treatment.","A Phase 1 Drug-Drug Interaction Study Between Brigatinib and the CYP3A Substrate Midazolam in Patients With ALK-Positive or ROS1-Positive Solid Tumors","Brigatinib-1001","Carcinoma, Advanced ALK+ or ROS1+Non-Small-Cell Lung, Neoplasm, Advanced ALK+ or ROS1+Solid Tumors","Small Cell Lung Cancer|Noma|Carcinoma|Non-Small-Cell Lung Cancer|Small Cell Carcinoma","Oncology Solid Tumor|Mouth Diseases","Oncology|Ear, Nose and Throat","Experimental","Midazolam 3 mg + Brigatinib 90 mg","Midazolam 3 mg, orally, once on Day 1, followed by brigatinib 90 mg, orally, once daily on Days 2 to 8, further followed by brigatinib 180 mg, orally, once daily on Days 9 to 28 in Part A Cycle 1 (28 days treatment cycle). Participants escalating to brigatinib 180 mg once daily will also receive midazolam 3 mg, orally, once on Day 21 of Part A Cycle 1. After completion of Part A, participants will continue into Part B. Participants in Part B will receive brigatinib up to 180 mg (or at the highest tolerated dose in Part A), orally, once daily in a 28 day treatment cycle, up to a maximum of 23 cycles or until progression of disease, unacceptable toxicity, or another discontinuation criterion is met.","Drug","Midazolam|Brigatinib","Midazolam syrup.|Brigatinib tablets.","Alunbrig","Midazolam 3 mg + Brigatinib 90 mg","\n\n 1. Locally advanced or metastatic solid tumors who meet 1 of the following 4 criteria: * With locally advanced or metastatic ALK-positive NSCLC who have progressed on or are intolerant to treatment with at least 1 other ALK inhibitor.\n     * With ALK-positive nonlung solid tumors that are locally advanced or metastatic and for whom no standard, nonexperimental therapy is available.\n     * With locally advanced or metastatic ROS1-positive NSCLC who have progressed on crizotinib therapy or are intolerant to crizotinib, or\n     * With ROS1-positive nonlung solid tumors that are locally advanced or metastatic and for whom no standard, nonexperimental therapy is available.\n    \n    \n 2. Eastern cooperative Oncology Group (ECOG) performance status of 0 or 1.\n 3. Have at least 1 target lesion per response evaluation criteria in solid tumors (RECIST) version 1.1.\n 4. Have recovered from toxicities related to prior anticancer therapy to National Cancer Institute common terminology criteria for adverse events (NCI CTCAE) version 4.03 Grade less than or equal to (<=) 1.\n 5. Suitable venous access for study-required blood sampling (that is, including PK and laboratory safety tests).\n\n","\n\n 1. Systemic treatment with strong or moderate cytochrome P450 3A (CYP3A) inhibitors or inducers within 14 days before enrollment.\n 2. Prior therapy with brigatinib.\n 3. Received prior ALK-inhibitor therapy within 7 days before the first dose of study drug.\n 4. Treatment with any investigational systemic anticancer agents within 14 days or 5 half-lives, whichever is longer, before the first dose of study drug.\n 5. Received chemotherapy or radiation therapy within 14 days before the first dose of study drug, except for stereotactic radiosurgery (SRS) or stereotactic body radiation therapy.\n 6. Received antineoplastic monoclonal antibodies within 30 days before the first dose of study drug.\n 7. Had major surgery within 30 days before the first dose of study drug. Minor surgical procedures, such as catheter placement or minimally invasive biopsies, are allowed.\n 8. Have current spinal cord compression (symptomatic or asymptomatic and detected by radiographic imaging). Patients with leptomeningeal disease and without cord compression are allowed.",{"$nulls":4},"Actual","2018-02-05","Actual","Actual","2021-05-18","Anticipated","2020-05-01","2018-01-29","2018-01-29","2020-05-11","No","Drug therapy, brigatinib, lung cancer, ALK, ROS1","Interventional","Other","Sequential Assignment","None (Open Label)","N/A","18 Years",null,"All",null,"No","Yes\nTakeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.",{"$nulls":3},"Yes","No",{"$nulls":17},"U1111-1203-0166|2018-001624-19","WHO|EudraCT Number","Part A: AUCâˆž: Area Under the Plasma Concentration-Time Curve from Time 0 to Infinity (AUCâˆž) for Midazolam|Part A: Cmax: Maximum Observed Plasma Concentration for Midazolam|Part A: Tmax: Time to Reach the Maximum Observed Plasma Concentration (Cmax) for Midazolam","Days 1 and 21 pre-dose and at multiple time points (up to 24 hours) post-dose",{"$nulls":7},"Paris, Ile-De-|Marseille, Provence Alpes Cote D'Azur, France, 13005|Bologna, Italy, 40138 Ospedale San RaffaeleMilano, Italy, 20132 Istituto Europeo Di OncologiaMilano, Italy, 20141 Azienda Ospedaliero Universitaria Di ParmaParma, Italy, 43126 Ospedale Santa Maria Delle CrociRavenna, Italy, 48121|Aviano, Pordenone, Italy, 33081|Amsterdam, Noord-Holland, Netherlands, 1066 Cx|Barcelona, Spain, 8028 Hospital Universitari Vall D'HebronBarcelona, Spain, 8035 Hospital Universitario Ramon Y CajalMadrid, Spain, 28034 Hospital Universitario Fundacion Jimenez DiazMadrid, Spain, 28040 Hm Centro Integral Oncologico Clara CampalMadrid, Spain, 28050",null,"France|Italy|Netherlands|Spain","Groupe Hospitalier Bichat-Claude Bernard - Hopital Bichat|Provence Alpes Cote D'Azur Hopital De La Timone|Policlinico Sant'Orsola Malpighi|Pordenone Centro Di Riferimento Oncologico Di Aviano|Cancer Institute|Hospital Universitario Dexeus",{"$nulls":3},"Medical Director","2020-05-11","2020-05-25T16:40:16.557","2020-05-26T17:10:42.972","NCT03420742"]
["5ecbf4f0e2561b1b11905f17","NCT03420768","2018-02-05","Bristol-Myers Squibb","BMY","Not yet recruiting","A Study of Experimental Medication BMS-986263 in Adults With Advanced Hepatic Fibrosis After Cure of Hepatitis C","Bms-986263",null,"Yes","['Bms-986263']","Unknown",null,"Phase 2",2,165,"Anticipated","2018-03-01","2020-08-30",{"$nulls":5},"This is a study of experimental medication BMS-986263 in adult patients with advanced hepatic fibrosis (scar tissue in the liver caused by inflammation that is far on in progress) after the patient is cured of hepatitis C (an infection caused by a virus that attacks the liver and leads to inflammation).",null,"A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multiple Dose Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BMS-986263 in Adults With Advanced Hepatic Fibrosis After Virologic Cure of Hepatitis C","IM025-006","Hepatic Cirrhosis\nLiver Fibrosis","Liver Cirrhosis","Biliary Tract Diseases","Gastrointestinal","Experimental|Placebo Comparator","BMS-986263|Placebo","BMS-986263 administration|Placebo Control","Drug","BMS-986263|Placebo","Intravenous administration weekly",null,"BMS-986263|Placebo","\n\n * Participants must provide documentation showing a sustained virologic response (SVR) for at least 1 year (52 weeks) prior to the date of screening (SVR is defined as a negative hepatitis C RNA greater than or equal to 12 weeks from the end of therapy)\n * Participants must have METAVIR Stage 3 or 4 (or equivalent if using other classification; eg, Ishak)\n\n","\n\n * Other causes of liver disease (eg, alcoholic liver disease, HBV [serologically positive as determined using United States Centers for Disease Control and Prevention guidance for interpretation of hepatitis B serologic test results], autoimmune hepatitis, drug-induced hepatotoxicity, Wilson disease, iron overload, alpha-1-antitrypsin deficiency, NASH, hemochromatosis)\n * Participants having liver diseases associated with infection with any other hepatitis virus\n * Detectable HCV RNA at screening\n * Child-Pugh score > 6\n * Model for End-Stage Liver Disease score >12\n * Evidence of HCC at screening based on alpha-fetoprotein (AFP) levels: AFP > 100 ng/mL (> 82.6 IU/mL) OR AFP â‰¥ 50 and â‰¤ 100 ng/mL (â‰¥ 41.3 IU/mL and â‰¤ 82.6 IU/ mL) with liver ultrasound showing findings suspicious for HCC, or any imaging technique (eg, magnetic resonance imaging [MRI] or computed tomography; based on local assessment), or ultrasound\n * Blood transfusion in the last 6 months prior to screening due to the risk of re-infection with HCV, HBV, HIV, etc\n * Participant has any disease or condition which, in the opinion of the investigator, might compromise patient safety (eg, hematologic, cardiovascular, pulmonary, renal, gastrointestinal, hepatic, skeletal, central nervous system, or compliment-mediated disease); or other conditions that may interfere with the absorption, distribution, metabolism, or excretion of BMS 986263, or would place the participant at increased risk\n\nOther protocol defined inclusion/exclusion criteria could apply",{"$nulls":4},"Actual","2018-02-05","Actual","Anticipated","2020-08-31","Anticipated","2018-02-01","2018-01-29","2018-02-01","2018-02-01","Yes",null,"Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","21 Years","75 Years","All",null,"No",null,null,"URL: http://bms.com/studyconnect/Pages/home.aspx [http://bms.com/studyconnect/Pages/home.aspx] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: BMS Clinical Trial Patient Recruiting",null,"Yes","No",{"$nulls":19},"Number of participants with histological improvement in liver fibrosis based on liver biopsy","Up to 169 days",null,"Number of participants with greater than or equal to 15 percent decrease in liver stiffness as measured by magnetic resonance elastography (MRE)","Up to 169 days",null,"Clinical.Trials@bms.com","Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,","please email:","San Antonio, Texas, United States, 78215","Texas","United States","Local Institution",null,"First line of the email MUST contain NCT # and Site #.",null,"Bristol-Myers Squibb","2018-02-01","2020-05-25T16:40:16.915","2020-05-26T17:10:42.972","NCT03420768"]
["5ecbf4f1fe30261b1a04841d","NCT03420768","2018-02-28","Bristol-Myers Squibb","BMY","Recruiting","A Study of Experimental Medication BMS-986263 in Adults With Advanced Hepatic Fibrosis After Cure of Hepatitis C","Bms-986263",null,"Yes","['Bms-986263']","Unknown",null,"Phase 2",2,165,"Anticipated","2018-02-13","2020-08-30",{"$nulls":5},"This is a study of experimental medication BMS-986263 in adult patients with advanced hepatic fibrosis (scar tissue in the liver caused by inflammation that is far on in progress) after the patient is cured of hepatitis C (an infection caused by a virus that attacks the liver and leads to inflammation).",null,"A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multiple Dose Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BMS-986263 in Adults With Advanced Hepatic Fibrosis After Virologic Cure of Hepatitis C","IM025-006","Hepatic Cirrhosis\nLiver Fibrosis","Liver Cirrhosis","Biliary Tract Diseases","Gastrointestinal","Experimental|Placebo Comparator","BMS-986263|Placebo","BMS-986263 administration|Placebo Control","Drug","BMS-986263|Placebo","Intravenous administration weekly",null,"BMS-986263|Placebo","\n\n * Participants must provide documentation showing a sustained virologic response (SVR) for at least 1 year (52 weeks) prior to the date of screening (SVR is defined as a negative hepatitis C RNA greater than or equal to 12 weeks from the end of therapy)\n * Participants must have METAVIR Stage 3 or 4 (or equivalent if using other classification; eg, Ishak)\n\n","\n\n * Other causes of liver disease (eg, alcoholic liver disease, HBV [serologically positive as determined using United States Centers for Disease Control and Prevention guidance for interpretation of hepatitis B serologic test results], autoimmune hepatitis, drug-induced hepatotoxicity, Wilson disease, iron overload, alpha-1-antitrypsin deficiency, NASH, hemochromatosis)\n * Participants having liver diseases associated with infection with any other hepatitis virus\n * Detectable HCV RNA at screening\n * Child-Pugh score > 6\n * Model for End-Stage Liver Disease score >12\n * Evidence of HCC at screening based on alpha-fetoprotein (AFP) levels: AFP > 100 ng/mL (> 82.6 IU/mL) OR AFP â‰¥ 50 and â‰¤ 100 ng/mL (â‰¥ 41.3 IU/mL and â‰¤ 82.6 IU/ mL) with liver ultrasound showing findings suspicious for HCC, or any imaging technique (eg, magnetic resonance imaging [MRI] or computed tomography; based on local assessment), or ultrasound\n * Blood transfusion in the last 6 months prior to screening due to the risk of re-infection with HCV, HBV, HIV, etc\n * Participant has any disease or condition which, in the opinion of the investigator, might compromise patient safety (eg, hematologic, cardiovascular, pulmonary, renal, gastrointestinal, hepatic, skeletal, central nervous system, or compliment-mediated disease); or other conditions that may interfere with the absorption, distribution, metabolism, or excretion of BMS 986263, or would place the participant at increased risk\n\nOther protocol defined inclusion/exclusion criteria could apply",{"$nulls":4},"Actual","2018-02-05","Actual","Anticipated","2020-08-31","Anticipated","2018-02-01","2018-01-29","2018-02-01","2018-02-26","Yes",null,"Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","21 Years","75 Years","All",null,"No",null,null,"URL: http://bms.com/studyconnect/Pages/home.aspx [http://bms.com/studyconnect/Pages/home.aspx] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: BMS Clinical Trial Patient Recruiting",null,"Yes","No",{"$nulls":19},"Number of participants with histological improvement in liver fibrosis based on liver biopsy","Up to 169 days",null,"Number of participants with greater than or equal to 15 percent decrease in liver stiffness as measured by magnetic resonance elastography (MRE)","Up to 169 days",null,"Clinical.Trials@bms.com","Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,","please email:","San Antonio, Texas, United States, 78215","Texas","United States","American Research Corporation",null,"First line of the email MUST contain NCT # and Site #.",null,"Bristol-Myers Squibb","2018-02-26","2020-05-25T16:40:17.012","2020-05-26T17:10:42.972","NCT03420768"]
["5ecbf4f0307e3d1b1f8d9eae","NCT03420768","2018-03-14","Bristol-Myers Squibb","BMY","Recruiting","A Study of Experimental Medication BMS-986263 in Adults With Advanced Hepatic Fibrosis After Cure of Hepatitis C","Bms-986263",null,"Yes","['Bms-986263']","Unknown",null,"Phase 2",2,165,"Anticipated","2018-02-13","2020-08-30",{"$nulls":5},"This is a study of experimental medication BMS-986263 in adult patients with advanced hepatic fibrosis (scar tissue in the liver caused by inflammation that is far on in progress) after the patient is cured of hepatitis C (an infection caused by a virus that attacks the liver and leads to inflammation).",null,"A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multiple Dose Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BMS-986263 in Adults With Advanced Hepatic Fibrosis After Virologic Cure of Hepatitis C","IM025-006","Hepatic Cirrhosis\nLiver Fibrosis","Liver Cirrhosis","Biliary Tract Diseases","Gastrointestinal","Experimental|Placebo Comparator","BMS-986263|Placebo","BMS-986263 administration|Placebo Control","Drug","BMS-986263|Placebo","Intravenous administration weekly",null,"BMS-986263|Placebo","\n\n * Participants must provide documentation showing a sustained virologic response (SVR) for at least 1 year (52 weeks) prior to the date of screening (SVR is defined as a negative hepatitis C RNA greater than or equal to 12 weeks from the end of therapy)\n * Participants must have METAVIR Stage 3 or 4 (or equivalent if using other classification; eg, Ishak)\n\n","\n\n * Other causes of liver disease (eg, alcoholic liver disease, HBV [serologically positive as determined using United States Centers for Disease Control and Prevention guidance for interpretation of hepatitis B serologic test results], autoimmune hepatitis, drug-induced hepatotoxicity, Wilson disease, iron overload, alpha-1-antitrypsin deficiency, NASH, hemochromatosis)\n * Participants having liver diseases associated with infection with any other hepatitis virus\n * Detectable HCV RNA at screening\n * Child-Pugh score > 6\n * Model for End-Stage Liver Disease score >12\n * Evidence of HCC at screening based on alpha-fetoprotein (AFP) levels: AFP > 100 ng/mL (> 82.6 IU/mL) OR AFP â‰¥ 50 and â‰¤ 100 ng/mL (â‰¥ 41.3 IU/mL and â‰¤ 82.6 IU/ mL) with liver ultrasound showing findings suspicious for HCC, or any imaging technique (eg, magnetic resonance imaging [MRI] or computed tomography; based on local assessment), or ultrasound\n * Blood transfusion in the last 6 months prior to screening due to the risk of re-infection with HCV, HBV, HIV, etc\n * Participant has any disease or condition which, in the opinion of the investigator, might compromise patient safety (eg, hematologic, cardiovascular, pulmonary, renal, gastrointestinal, hepatic, skeletal, central nervous system, or compliment-mediated disease); or other conditions that may interfere with the absorption, distribution, metabolism, or excretion of BMS 986263, or would place the participant at increased risk\n\nOther protocol defined inclusion/exclusion criteria could apply",{"$nulls":4},"Actual","2018-02-05","Actual","Anticipated","2020-08-31","Anticipated","2018-03-01","2018-01-29","2018-02-01","2018-03-13","Yes",null,"Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","21 Years","75 Years","All",null,"No",null,null,"URL: http://bms.com/studyconnect/Pages/home.aspx [http://bms.com/studyconnect/Pages/home.aspx] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: BMS Clinical Trial Patient Recruiting",null,"Yes","No",{"$nulls":19},"Number of participants with histological improvement in liver fibrosis based on liver biopsy","Up to 169 days",null,"Number of participants with greater than or equal to 15 percent decrease in liver stiffness as measured by magnetic resonance elastography (MRE)","Up to 169 days",null,"Clinical.Trials@bms.com","Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,","please email:","San Antonio, Texas, United States, 78215","Texas","United States","The Texas Liver Institute",null,"First line of the email MUST contain NCT # and Site #.",null,"Bristol-Myers Squibb","2018-03-13","2020-05-25T16:40:16.911","2020-05-26T17:10:42.972","NCT03420768"]
["5ecbf4f0feab101b15530a4c","NCT03420768","2018-04-10","Bristol-Myers Squibb","BMY","Recruiting","A Study of Experimental Medication BMS-986263 in Adults With Advanced Hepatic Fibrosis After Cure of Hepatitis C","Bms-986263",null,"Yes","['Bms-986263']","Unknown",null,"Phase 2",2,165,"Anticipated","2018-02-13","2020-08-30",{"$nulls":5},"This is a study of experimental medication BMS-986263 in adult patients with advanced hepatic fibrosis (scar tissue in the liver caused by inflammation that is far on in progress) after the patient is cured of hepatitis C (an infection caused by a virus that attacks the liver and leads to inflammation).",null,"A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multiple Dose Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BMS-986263 in Adults With Advanced Hepatic Fibrosis After Virologic Cure of Hepatitis C","IM025-006","Hepatic Cirrhosis\nLiver Fibrosis","Liver Cirrhosis","Biliary Tract Diseases","Gastrointestinal","Experimental|Placebo Comparator","BMS-986263|Placebo","BMS-986263 administration|Placebo Control","Drug","BMS-986263|Placebo","Intravenous administration weekly",null,"BMS-986263|Placebo","\n\n * Participants must provide documentation showing a sustained virologic response (SVR) for at least 1 year (52 weeks) prior to the date of screening (SVR is defined as a negative hepatitis C RNA greater than or equal to 12 weeks from the end of therapy)\n * Participants must have METAVIR Stage 3 or 4 (or equivalent if using other classification; eg, Ishak)\n\n","\n\n * Other causes of liver disease (eg, alcoholic liver disease, HBV [serologically positive as determined using United States Centers for Disease Control and Prevention guidance for interpretation of hepatitis B serologic test results], autoimmune hepatitis, drug-induced hepatotoxicity, Wilson disease, iron overload, alpha-1-antitrypsin deficiency, NASH, hemochromatosis)\n * Participants having liver diseases associated with infection with any other hepatitis virus\n * Detectable HCV RNA at screening\n * Child-Pugh score > 6\n * Model for End-Stage Liver Disease score >12\n * Evidence of HCC at screening based on alpha-fetoprotein (AFP) levels: AFP > 100 ng/mL (> 82.6 IU/mL) OR AFP â‰¥ 50 and â‰¤ 100 ng/mL (â‰¥ 41.3 IU/mL and â‰¤ 82.6 IU/ mL) with liver ultrasound showing findings suspicious for HCC, or any imaging technique (eg, magnetic resonance imaging [MRI] or computed tomography; based on local assessment), or ultrasound\n * Blood transfusion in the last 6 months prior to screening due to the risk of re-infection with HCV, HBV, HIV, etc\n * Participant has any disease or condition which, in the opinion of the investigator, might compromise patient safety (eg, hematologic, cardiovascular, pulmonary, renal, gastrointestinal, hepatic, skeletal, central nervous system, or compliment-mediated disease); or other conditions that may interfere with the absorption, distribution, metabolism, or excretion of BMS 986263, or would place the participant at increased risk\n\nOther protocol defined inclusion/exclusion criteria could apply",{"$nulls":4},"Actual","2018-02-05","Actual","Anticipated","2020-08-31","Anticipated","2018-04-01","2018-01-29","2018-02-01","2018-04-09","Yes",null,"Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","21 Years","75 Years","All",null,"No",null,null,"URL: http://bms.com/studyconnect/Pages/home.aspx [http://bms.com/studyconnect/Pages/home.aspx] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: BMS Clinical Trial Patient Recruiting",null,"Yes","No",{"$nulls":19},"Number of participants with histological improvement in liver fibrosis based on liver biopsy","Up to 169 days",null,"Number of participants with greater than or equal to 15 percent decrease in liver stiffness as measured by magnetic resonance elastography (MRE)","Up to 169 days",null,"Clinical.Trials@bms.com","Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,","please email:","San Antonio, Texas, United States, 78215","Texas","United States","The Texas Liver Institute",null,"First line of the email MUST contain NCT # and Site #.",null,"Bristol-Myers Squibb","2018-04-09","2020-05-25T16:40:16.999","2020-05-26T17:10:42.972","NCT03420768"]
["5ecbf4f011702c1b1b916c29","NCT03420768","2018-08-09","Bristol-Myers Squibb","BMY","Recruiting","A Study of Experimental Medication BMS-986263 in Adults With Advanced Hepatic Fibrosis After Cure of Hepatitis C","Bms-986263",null,"Yes","['Bms-986263']","Unknown",null,"Phase 2",7,165,"Anticipated","2018-02-13","2020-08-30",{"$nulls":5},"This is a study of experimental medication BMS-986263 in adult patients with advanced hepatic fibrosis (scar tissue in the liver caused by inflammation that is far on in progress) after the patient is cured of hepatitis C (an infection caused by a virus that attacks the liver and leads to inflammation).",null,"A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multiple Dose Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BMS-986263 in Adults With Advanced Hepatic Fibrosis After Virologic Cure of Hepatitis C","IM025-006","Hepatic Cirrhosis\nLiver Fibrosis","Liver Cirrhosis","Biliary Tract Diseases","Gastrointestinal","Experimental|Placebo Comparator","Part 1 BMS-986263 45mg weekly|Part 1 BMS-986263 90mg weekly|Part 1 Placebo weekly|Part 2 BMS-986263 45mg every 2 weeks|Part 2 BMS-986263 90mg every 2 weeks|Part 2 BMS-986263 90mg every 4 weeks|Part 2 Placebo every 2 weeks",null,"Drug","BMS-986263|Placebo","Administered by intravenous (IV) infusion",null,"Part 1 BMS-986263 45mg weekly|Part 1 BMS-986263 90mg weekly|Part 1 Placebo weekly|Part 2 BMS-986263 45mg every 2 weeks|Part 2 BMS-986263 90mg every 2 weeks|Part 2 BMS-986263 90mg every 4 weeks|Part 2 Placebo every 2 weeks","\n\n * Participants must provide documentation showing a sustained virologic response (SVR) for at least 1 year (52 weeks) prior to the date of screening (SVR is defined as a negative hepatitis C RNA greater than or equal to 12 weeks from the end of therapy)\n * Participants must have METAVIR Stage 3 or 4 (or equivalent if using other classification; eg, Ishak)\n\n","\n\n * Other causes of liver disease (eg, alcoholic liver disease, HBV [serologically positive as determined using United States Centers for Disease Control and Prevention guidance for interpretation of hepatitis B serologic test results], autoimmune hepatitis, drug-induced hepatotoxicity, Wilson disease, iron overload, alpha-1-antitrypsin deficiency, NASH, hemochromatosis)\n * Participants having liver diseases associated with infection with any other hepatitis virus\n * Detectable HCV RNA at screening\n * Child-Pugh score > 6\n * Model for End-Stage Liver Disease score >12\n * Evidence of HCC at screening based on alpha-fetoprotein (AFP) levels: AFP > 100 ng/mL (> 82.6 IU/mL) OR AFP â‰¥ 50 and â‰¤ 100 ng/mL (â‰¥ 41.3 IU/mL and â‰¤ 82.6 IU/ mL) with liver ultrasound showing findings suspicious for HCC, or any imaging technique (eg, magnetic resonance imaging [MRI] or computed tomography; based on local assessment), or ultrasound\n * Blood transfusion in the last 6 months prior to screening due to the risk of re-infection with HCV, HBV, HIV, etc\n * Participant has any disease or condition which, in the opinion of the investigator, might compromise patient safety (eg, hematologic, cardiovascular, pulmonary, renal, gastrointestinal, hepatic, skeletal, central nervous system, or compliment-mediated disease); or other conditions that may interfere with the absorption, distribution, metabolism, or excretion of BMS 986263, or would place the participant at increased risk\n\nOther protocol defined inclusion/exclusion criteria could apply",{"$nulls":4},"Actual","2018-02-05","Actual","Anticipated","2020-08-31","Anticipated","2018-08-01","2018-01-29","2018-02-01","2018-08-08","Yes",null,"Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","21 Years","75 Years","All",null,"No",null,null,"URL: http://bms.com/studyconnect/Pages/home.aspx [http://bms.com/studyconnect/Pages/home.aspx] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: BMS Clinical Trial Patient Recruiting",null,"Yes","No",{"$nulls":19},"Number of participants with histological improvement in liver fibrosis based on liver biopsy","Up to 169 days",null,"Number of participants with greater than or equal to 15 percent decrease in liver stiffness as measured by magnetic resonance elastography (MRE)","Up to 169 days",null,"Clinical.Trials@bms.com","Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,","please email:","San Antonio, Texas, United States, 78215","Texas","United States","The Texas Liver Institute",null,"First line of the email MUST contain NCT # and Site #.",null,"Bristol-Myers Squibb","2018-08-08","2020-05-25T16:40:16.918","2020-05-26T17:10:42.972","NCT03420768"]
["5ecbf4f1e2561b1b11905f18","NCT03420768","2019-01-23","Bristol-Myers Squibb","BMY","Recruiting","A Study of Experimental Medication BMS-986263 in Adults With Advanced Hepatic Fibrosis After Cure of Hepatitis C","Bms-986263",null,"Yes","['Bms-986263']","Unknown",null,"Phase 2",7,165,"Anticipated","2018-02-13","2020-08-30",{"$nulls":5},"This is a study of experimental medication BMS-986263 in adult patients with advanced hepatic fibrosis (scar tissue in the liver caused by inflammation that is far on in progress) after the patient is cured of hepatitis C (an infection caused by a virus that attacks the liver and leads to inflammation).",null,"A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multiple Dose Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BMS-986263 in Adults With Advanced Hepatic Fibrosis After Virologic Cure of Hepatitis C","IM025-006","Hepatic Cirrhosis\nLiver Fibrosis","Liver Cirrhosis","Biliary Tract Diseases","Gastrointestinal","Experimental|Placebo Comparator","Part 1 BMS-986263 45mg weekly|Part 1 BMS-986263 90mg weekly|Part 1 Placebo weekly|Part 2 BMS-986263 45mg every 2 weeks|Part 2 BMS-986263 90mg every 2 weeks|Part 2 BMS-986263 90mg every 4 weeks|Part 2 Placebo every 2 weeks",null,"Drug","BMS-986263|Placebo","Administered by intravenous (IV) infusion",null,"Part 1 BMS-986263 45mg weekly|Part 1 BMS-986263 90mg weekly|Part 1 Placebo weekly|Part 2 BMS-986263 45mg every 2 weeks|Part 2 BMS-986263 90mg every 2 weeks|Part 2 BMS-986263 90mg every 4 weeks|Part 2 Placebo every 2 weeks","\n\n * Participants must provide documentation showing a sustained virologic response (SVR) for at least 1 year (52 weeks) prior to the date of screening (SVR is defined as a negative hepatitis C RNA greater than or equal to 12 weeks from the end of therapy)\n * Participants must have METAVIR Stage 3 or 4 (or equivalent if using other classification; eg, Ishak)\n\n","\n\n * Other causes of liver disease (eg, alcoholic liver disease, HBV [serologically positive as determined using United States Centers for Disease Control and Prevention guidance for interpretation of hepatitis B serologic test results], autoimmune hepatitis, drug-induced hepatotoxicity, Wilson disease, iron overload, alpha-1-antitrypsin deficiency, NASH, hemochromatosis)\n * Participants having liver diseases associated with infection with any other hepatitis virus\n * Detectable HCV RNA at screening\n * Child-Pugh score > 6\n * Model for End-Stage Liver Disease score >12\n * Evidence of HCC at screening based on alpha-fetoprotein (AFP) levels: AFP > 100 ng/mL (> 82.6 IU/mL) OR AFP â‰¥ 50 and â‰¤ 100 ng/mL (â‰¥ 41.3 IU/mL and â‰¤ 82.6 IU/ mL) with liver ultrasound showing findings suspicious for HCC, or any imaging technique (eg, magnetic resonance imaging [MRI] or computed tomography; based on local assessment), or ultrasound\n * Blood transfusion in the last 6 months prior to screening due to the risk of re-infection with HCV, HBV, HIV, etc\n * Participant has any disease or condition which, in the opinion of the investigator, might compromise patient safety (eg, hematologic, cardiovascular, pulmonary, renal, gastrointestinal, hepatic, skeletal, central nervous system, or compliment-mediated disease); or other conditions that may interfere with the absorption, distribution, metabolism, or excretion of BMS 986263, or would place the participant at increased risk\n\nOther protocol defined inclusion/exclusion criteria could apply",{"$nulls":4},"Actual","2018-02-05","Actual","Anticipated","2020-08-31","Anticipated","2019-01-01","2018-01-29","2018-02-01","2019-01-18","Yes",null,"Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","21 Years","75 Years","All",null,"No",null,null,"URL: https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html [https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: BMS Clinical Trial Information",null,"Yes","No",{"$nulls":19},"Number of participants with histological improvement in liver fibrosis based on liver biopsy","Up to 169 days",null,"Number of participants with greater than or equal to 15 percent decrease in liver stiffness as measured by magnetic resonance elastography (MRE)","Up to 169 days",null,"Clinical.Trials@bms.com","Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,","please email:","San Antonio, Texas, United States, 78215","Texas","United States","The Texas Liver Institute",null,"First line of the email MUST contain NCT # and Site #.",null,"Bristol-Myers Squibb","2019-01-18","2020-05-25T16:40:17.130","2020-05-26T17:10:42.972","NCT03420768"]
["5ecbf4f1307e3d1b1f8d9eaf","NCT03420768","2019-08-14","Bristol-Myers Squibb","BMY","Recruiting","A Study of Experimental Medication BMS-986263 in Adults With Advanced Hepatic Fibrosis After Cure of Hepatitis C","Bms-986263",null,"Yes","['Bms-986263']","Unknown",null,"Phase 2",7,165,"Anticipated","2018-02-13","2020-08-30",{"$nulls":5},"This is a study of experimental medication BMS-986263 in adult patients with advanced hepatic fibrosis (scar tissue in the liver caused by inflammation that is far on in progress) after the patient is cured of hepatitis C (an infection caused by a virus that attacks the liver and leads to inflammation).",null,"A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multiple Dose Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BMS-986263 in Adults With Advanced Hepatic Fibrosis After Virologic Cure of Hepatitis C","IM025-006","Hepatic Cirrhosis\nLiver Fibrosis","Liver Cirrhosis","Biliary Tract Diseases","Gastrointestinal","Experimental|Placebo Comparator","Part 1 BMS-986263 45mg weekly|Part 1 BMS-986263 90mg weekly|Part 1 Placebo weekly|Part 2 BMS-986263 45mg every 2 weeks|Part 2 BMS-986263 90mg every 2 weeks|Part 2 BMS-986263 90mg every 4 weeks|Part 2 Placebo every 2 weeks",null,"Drug","BMS-986263|Placebo","Administered by intravenous (IV) infusion",null,"Part 1 BMS-986263 45mg weekly|Part 1 BMS-986263 90mg weekly|Part 1 Placebo weekly|Part 2 BMS-986263 45mg every 2 weeks|Part 2 BMS-986263 90mg every 2 weeks|Part 2 BMS-986263 90mg every 4 weeks|Part 2 Placebo every 2 weeks","\n\n * Participants must provide documentation showing a sustained virologic response (SVR) for at least 1 year (52 weeks) prior to the date of screening (SVR is defined as a negative hepatitis C RNA greater than or equal to 12 weeks from the end of therapy)\n * Participants must have METAVIR Stage 3 or 4 (or equivalent if using other classification; eg, Ishak)\n\n","\n\n * Other causes of liver disease (eg, alcoholic liver disease, HBV [serologically positive as determined using United States Centers for Disease Control and Prevention guidance for interpretation of hepatitis B serologic test results], autoimmune hepatitis, drug-induced hepatotoxicity, Wilson disease, iron overload, alpha-1-antitrypsin deficiency, NASH, hemochromatosis)\n * Participants having liver diseases associated with infection with any other hepatitis virus\n * Detectable HCV RNA at screening\n * Child-Pugh score > 6\n * Model for End-Stage Liver Disease score >12\n * Evidence of HCC at screening based on alpha-fetoprotein (AFP) levels: AFP > 100 ng/mL (> 82.6 IU/mL) OR AFP â‰¥ 50 and â‰¤ 100 ng/mL (â‰¥ 41.3 IU/mL and â‰¤ 82.6 IU/ mL) with liver ultrasound showing findings suspicious for HCC, or any imaging technique (eg, magnetic resonance imaging [MRI] or computed tomography; based on local assessment), or ultrasound\n * Blood transfusion in the last 6 months prior to screening due to the risk of re-infection with HCV, HBV, HIV, etc\n * Participant has any disease or condition which, in the opinion of the investigator, might compromise patient safety (eg, hematologic, cardiovascular, pulmonary, renal, gastrointestinal, hepatic, skeletal, central nervous system, or compliment-mediated disease); or other conditions that may interfere with the absorption, distribution, metabolism, or excretion of BMS 986263, or would place the participant at increased risk\n\nOther protocol defined inclusion/exclusion criteria could apply",{"$nulls":4},"Actual","2018-02-05","Actual","Anticipated","2020-08-31","Anticipated","2019-08-01","2018-01-29","2018-02-01","2019-08-12","Yes",null,"Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","21 Years","75 Years","All",null,"No",null,null,"URL: https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html [https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: BMS Clinical Trial Information",null,"Yes","No",{"$nulls":19},"Number of participants with histological improvement in liver fibrosis based on liver biopsy","Up to 169 days",null,"Number of participants with greater than or equal to 15 percent decrease in liver stiffness as measured by magnetic resonance elastography (MRE)","Up to 169 days",null,"Clinical.Trials@bms.com","Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,","please email:","San Antonio, Texas, United States, 78215","Texas","United States","The Texas Liver Institute",null,"First line of the email MUST contain NCT # and Site #.",null,"Bristol-Myers Squibb","2019-08-12","2020-05-25T16:40:17.043","2020-05-26T17:10:42.972","NCT03420768"]
["5ecbf4f1feab101b15530a4d","NCT03420768","2019-11-27","Bristol-Myers Squibb","BMY","Recruiting","A Study of Experimental Medication BMS-986263 in Adults With Advanced Hepatic Fibrosis After Cure of Hepatitis C","Bms-986263",null,"Yes","['Bms-986263']","Unknown",null,"Phase 2",7,165,"Anticipated","2018-02-13","2018-12-10",{"$nulls":5},"This is a study of experimental medication BMS-986263 in adult patients with advanced hepatic fibrosis (scar tissue in the liver caused by inflammation that is far on in progress) after the patient is cured of hepatitis C (an infection caused by a virus that attacks the liver and leads to inflammation).",null,"A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multiple Dose Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BMS-986263 in Adults With Advanced Hepatic Fibrosis After Virologic Cure of Hepatitis C","IM025-006","Hepatic Cirrhosis\nLiver Fibrosis","Liver Cirrhosis","Biliary Tract Diseases","Gastrointestinal","Experimental|Placebo Comparator","Part 1 BMS-986263 45mg weekly|Part 1 BMS-986263 90mg weekly|Part 1 Placebo weekly|Part 2 BMS-986263 45mg every 2 weeks|Part 2 BMS-986263 90mg every 2 weeks|Part 2 BMS-986263 90mg every 4 weeks|Part 2 Placebo every 2 weeks",null,"Drug","BMS-986263|Placebo","Administered by intravenous (IV) infusion",null,"Part 1 BMS-986263 45mg weekly|Part 1 BMS-986263 90mg weekly|Part 1 Placebo weekly|Part 2 BMS-986263 45mg every 2 weeks|Part 2 BMS-986263 90mg every 2 weeks|Part 2 BMS-986263 90mg every 4 weeks|Part 2 Placebo every 2 weeks","\n\n * Participants must provide documentation showing a sustained virologic response (SVR) for at least 1 year (52 weeks) prior to the date of screening (SVR is defined as a negative hepatitis C RNA greater than or equal to 12 weeks from the end of therapy)\n * Participants must have METAVIR Stage 3 or 4 (or equivalent if using other classification; eg, Ishak)\n\n","\n\n * Other causes of liver disease (eg, alcoholic liver disease, HBV [serologically positive as determined using United States Centers for Disease Control and Prevention guidance for interpretation of hepatitis B serologic test results], autoimmune hepatitis, drug-induced hepatotoxicity, Wilson disease, iron overload, alpha-1-antitrypsin deficiency, NASH, hemochromatosis)\n * Participants having liver diseases associated with infection with any other hepatitis virus\n * Detectable HCV RNA at screening\n * Child-Pugh score > 6\n * Model for End-Stage Liver Disease score >12\n * Evidence of HCC at screening based on alpha-fetoprotein (AFP) levels: AFP > 100 ng/mL (> 82.6 IU/mL) OR AFP â‰¥ 50 and â‰¤ 100 ng/mL (â‰¥ 41.3 IU/mL and â‰¤ 82.6 IU/ mL) with liver ultrasound showing findings suspicious for HCC, or any imaging technique (eg, magnetic resonance imaging [MRI] or computed tomography; based on local assessment), or ultrasound\n * Blood transfusion in the last 6 months prior to screening due to the risk of re-infection with HCV, HBV, HIV, etc\n * Participant has any disease or condition which, in the opinion of the investigator, might compromise patient safety (eg, hematologic, cardiovascular, pulmonary, renal, gastrointestinal, hepatic, skeletal, central nervous system, or compliment-mediated disease); or other conditions that may interfere with the absorption, distribution, metabolism, or excretion of BMS 986263, or would place the participant at increased risk\n\nOther protocol defined inclusion/exclusion criteria could apply",{"$nulls":4},"Actual","2018-02-05","Actual","Actual","2020-08-31","Anticipated","2019-11-01","2018-01-29","2018-02-01","2019-11-26","Yes",null,"Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","21 Years","75 Years","All",null,"No",null,null,"URL: https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html [https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: BMS Clinical Trial Information",null,"Yes","No",{"$nulls":19},"Number of participants with histological improvement in liver fibrosis based on liver biopsy","Up to 169 days",null,"Number of participants with greater than or equal to 15 percent decrease in liver stiffness as measured by magnetic resonance elastography (MRE)","Up to 169 days",null,"Clinical.Trials@bms.com","Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,","please email:","San Antonio, Texas, United States, 78215","Texas","United States","The Texas Liver Institute",null,"First line of the email MUST contain NCT # and Site #.",null,"Bristol-Myers Squibb","2019-11-26","2020-05-25T16:40:17.473","2020-05-26T17:10:42.972","NCT03420768"]
["5ecbf4f1fe30261b1a04841e","NCT03420768","2019-12-11","Bristol-Myers Squibb","BMY","Completed","A Study of Experimental Medication BMS-986263 in Adults With Advanced Hepatic Fibrosis After Cure of Hepatitis C","Bms-986263",null,"Yes","['Bms-986263']","Unknown",null,"Phase 2",7,61,"Actual","2018-02-13","2018-12-10",{"$nulls":5},"This is a study of experimental medication BMS-986263 in adult patients with advanced hepatic fibrosis (scar tissue in the liver caused by inflammation that is far on in progress) after the patient is cured of hepatitis C (an infection caused by a virus that attacks the liver and leads to inflammation).",null,"A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multiple Dose Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BMS-986263 in Adults With Advanced Hepatic Fibrosis After Virologic Cure of Hepatitis C","IM025-006","Hepatic Cirrhosis\nLiver Fibrosis","Liver Cirrhosis","Biliary Tract Diseases","Gastrointestinal","Experimental|Placebo Comparator","Part 1 BMS-986263 45mg weekly|Part 1 BMS-986263 90mg weekly|Part 1 Placebo weekly|Part 2 BMS-986263 45mg every 2 weeks|Part 2 BMS-986263 90mg every 2 weeks|Part 2 BMS-986263 90mg every 4 weeks|Part 2 Placebo every 2 weeks",null,"Drug","BMS-986263|Placebo","Administered by intravenous (IV) infusion",null,"Part 1 BMS-986263 45mg weekly|Part 1 BMS-986263 90mg weekly|Part 1 Placebo weekly|Part 2 BMS-986263 45mg every 2 weeks|Part 2 BMS-986263 90mg every 2 weeks|Part 2 BMS-986263 90mg every 4 weeks|Part 2 Placebo every 2 weeks","\n\n * Participants must provide documentation showing a sustained virologic response (SVR) for at least 1 year (52 weeks) prior to the date of screening (SVR is defined as a negative hepatitis C RNA greater than or equal to 12 weeks from the end of therapy)\n * Participants must have METAVIR Stage 3 or 4 (or equivalent if using other classification; eg, Ishak)\n\n","\n\n * Other causes of liver disease (eg, alcoholic liver disease, HBV [serologically positive as determined using United States Centers for Disease Control and Prevention guidance for interpretation of hepatitis B serologic test results], autoimmune hepatitis, drug-induced hepatotoxicity, Wilson disease, iron overload, alpha-1-antitrypsin deficiency, NASH, hemochromatosis)\n * Participants having liver diseases associated with infection with any other hepatitis virus\n * Detectable HCV RNA at screening\n * Child-Pugh score > 6\n * Model for End-Stage Liver Disease score >12\n * Evidence of HCC at screening based on alpha-fetoprotein (AFP) levels: AFP > 100 ng/mL (> 82.6 IU/mL) OR AFP â‰¥ 50 and â‰¤ 100 ng/mL (â‰¥ 41.3 IU/mL and â‰¤ 82.6 IU/ mL) with liver ultrasound showing findings suspicious for HCC, or any imaging technique (eg, magnetic resonance imaging [MRI] or computed tomography; based on local assessment), or ultrasound\n * Blood transfusion in the last 6 months prior to screening due to the risk of re-infection with HCV, HBV, HIV, etc\n * Participant has any disease or condition which, in the opinion of the investigator, might compromise patient safety (eg, hematologic, cardiovascular, pulmonary, renal, gastrointestinal, hepatic, skeletal, central nervous system, or compliment-mediated disease); or other conditions that may interfere with the absorption, distribution, metabolism, or excretion of BMS 986263, or would place the participant at increased risk\n\nOther protocol defined inclusion/exclusion criteria could apply",{"$nulls":4},"Actual","2018-02-05","Actual","Actual","2019-05-28","Actual","2019-12-01","2018-01-29","2018-02-01","2019-12-09","Yes",null,"Interventional","Treatment","Parallel Assignment","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Randomized","21 Years","75 Years","All",null,"No",null,null,"URL: https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html [https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: BMS Clinical Trial Information",null,"Yes","No",{"$nulls":7},43808,43808,"December 11, 2019 [Actual]",{"$nulls":9},"Number of participants with histological improvement in liver fibrosis based on liver biopsy","Up to 169 days",null,"Number of participants with greater than or equal to 15 percent decrease in liver stiffness as measured by magnetic resonance elastography (MRE)","Up to 169 days",{"$nulls":4},"San Antonio, Texas, United States, 78215","Texas","United States","The Texas Liver Institute",{"$nulls":3},"Bristol-Myers Squibb","2019-12-09","2020-05-25T16:40:17.436","2020-05-26T17:10:42.972","NCT03420768"]
["5ecbf4f111702c1b1b916c2a","NCT03420781","2018-02-05","Allergan","AGN","Enrolling by invitation","Diabetic Gastroparesis Study With Randomized-withdrawal Period, Study 03","Relamorelin","GHS-R Agonist","Yes","['Relamorelin']","Yes","['GHS-R Agonist']","Phase 3",3,960,"Anticipated","2018-01-24","2022-04-05",{"$nulls":5},"A 46-week study to compare the efficacy of relamorelin with that of placebo in participants with diabetic gastroparesis (DG). At the end of the 40-week Treatment Period, participants will either continue on relamorelin or placebo for 6 additional weeks.",null,"A 46-week, Double-blind, Placebo-controlled, Phase 3 Study With a 6-week Randomized-withdrawal Period to Evaluate the Safety and Efficacy of Relamorelin in Patients With Diabetic Gastroparesis","RLM-MD-03","Gastroparesis\nDiabetes Mellitus","Paresis|Gastroparesis","Neurologic Manifestations|Gastrointestinal Diseases","Central Nervous System|Gastrointestinal","Experimental","Relamorelin 10 Î¼g|Relamorelin 10 Î¼g, followed by Placebo|Placebo, followed by Relamorelin 10 Î¼g","Relamorelin 10 Î¼g injected subcutaneously twice daily for 46 weeks.|Relamorelin 10 Î¼g injected subcutaneously twice daily for 40 weeks, followed by placebo injected twice daily for 6 weeks.|Placebo injected subcutaneously twice daily for 40 weeks, followed by Relamorelin 10 Î¼g injected twice daily for 6 weeks.","Drug","Relamorelin|Placebo","Relamorelin 10 Î¼g injected twice daily for 6, 40 or 46 weeks.|Placebo injected twice daily for 6 weeks or 40 weeks.",null,"Relamorelin 10 Î¼g|Relamorelin 10 Î¼g, followed by Placebo|Placebo, followed by Relamorelin 10 Î¼g","\n\n * Participants are eligible to be included in the study only if all the following criteria apply:\n * Participant met all inclusion/exclusion criteria of either Protocol RLM-MD-01 (NCT03285308) or Protocol RLM-MD-02 and successfully completed the study\n * Able to provide written informed consent (IC) prior to any study procedures and willing and able to comply with study procedures\n * In the opinion of the investigator, the participant demonstrated adequate compliance with the study procedures in Study RLM-MD-01 or RLM-MD-02\n\n","\n\n * Participants are excluded from the study if any of the following criteria apply:\n * Participant is not willing or able to abide by the restrictions regarding concomitant medicine use\n * Participant is planning to receive an investigational drug (other than study treatment) or investigational device at any time during Study RLM-MD-03\n * Participant has an unresolved adverse event (AE) or a clinically significant finding on physical examination, clinical laboratory test, or 12-lead electrocardiogram (ECG) that, in the investigator's opinion, would limit the participant's ability to participate in or complete the study\n * Any other reason that, in the investigator's opinion, would confound proper interpretation of the study or expose a participant to unacceptable risk, including renal, hepatic or cardiopulmonary disease",{"$nulls":4},"Actual","2018-02-05","Actual","Anticipated","2022-04-05","Anticipated","2018-01-01","2018-01-24","2018-02-01","2018-02-01","No","diabetic gastroparesis\nvomiting","Interventional","Treatment","Parallel Assignment","Triple (Participant, Care Provider, Investigator)","Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":19},"Diabetic Gastroparesis Symptom Severity Score (DGSSS) Week-12 Responder|Percentage of patients meeting the vomiting symptom responder criterion in each of the last 6 of the 12 weeks of treatment","Patients will assess severity of diabetic gastroparesis symptoms daily using an 11-point ordinal scale with 0 being least and 10 being the worst possible score. Patients will enter the score using an electronic diary.|Vomiting episodes will be patient-recorded daily using an electronic diary.","Baseline to Week 12","Nausea Week 12 Responder|Abdominal Pain Week 12 Responder|Bloating Week 12 Responder|Postprandial Fullness Week 12 Responder|DGSSS Week 40 Responder|DGSSS at Week 40|Vomiting Frequency at Week 40|Vomiting Week-40 Responder|DGSSS at Week 46|Number of Vomiting Episodes at Week 46|Number of Patients who experienced one or more Treatment Emergent Adverse Event (TEAE)","Nausea responder defined as a participant who has an least a 2-point improvement in the weekly symptom score at each of the last 6 weeks of the first 12 weeks of the 40-week Treatment Period. Nausea is assessed on an 11-point ordinal scale from 0 to 10, with 0 meaning no nausea, and 10 meaning the worst possible nausea.|Abdominal pain responder defined as a participant who has an at least a 2-point improvement in the weekly symptom score at each of the last 6 weeks of the first 12 weeks of the 40-week Treatment Period. Abdominal Pain is assessed on an 11-point ordinal scale from 0 to 10, with 0 meaning no abdominal Pain, and 10 meaning the worst possible abdominal pain.|Bloating responder defined as a participant who has an at least 2-point improvement in the weekly symptom score at each of the last 6 weeks of the first 12 weeks of the 40-week Treatment Period. Bloating is assessed on an 11-point ordinal scale from 0 to 10, with 0 meaning no bloating, and 10 meaning the worst possible bloating.|Postprandial Fullness responder defined as a participant who has an at least 2-point improvement in the weekly symptom score at each of the last 6 weeks of the first 12 weeks of the 40-week Treatment Period.\n\nPostprandial Fullness is assessed on an 11-point ordinal scale from 0 to 10, with 0 meaning no feeling of fullness until finishing a meal, and 10 meaning felling full after only a few bites.|DGSSS responder defined as a participant who has at least 10-point improvement in the DGSSS compared to baseline in each of the last 4 weeks of the 40-week Treatment Period.|Change from baseline to Week 40 in average weekly DGSSS. Average weekly scores are derived as the average of the weekly scores from the four weeks prior to Week 40 (Visit 7) in this study.|Change from baseline to Week 40 in average weekly number of vomiting episodes derived as the average of the weekly number of vomiting episodes during the four weeks prior to Week 40 (Visit 7) in this study.|Vomiting responder defined as a participant with zero weekly vomiting episodes during each of the last 4 weeks of the 40-week Treatment Period.|Change from baseline (CFB) to end of Randomized withdrawl period (RWP) in the average weekly DGSSS. Average weekly scores are derived as the average of the weekly scores from the six weeks of the RWP.|CFB to end of RWP in the average weekly number of vomiting episodes. Average weekly scores are derived as the average of the weekly number of vomiting episodes from the six weeks of the RWP.|The number of patients who experienced one or more TEAE during the 46 week treatment period.","Baseline to Week 12|Baseline to Week 40|Baseline to Week 46",{"$nulls":3},"Omaha, Nebraska, United States, 68114","Nebraska","United States","Diabetes And Endocrine Associates, Pc",{"$nulls":3},"Wieslaw (Wes) Bochenek, MD, PhD","2018-02-01","2020-05-25T16:40:17.488","2020-05-26T17:10:42.972","NCT03420781"]
["5ecbf4f2307e3d1b1f8d9eb0","NCT03420781","2018-02-19","Allergan","AGN","Enrolling by invitation","A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis Study 03","Relamorelin","GHS-R Agonist","Yes","['Relamorelin']","Yes","['GHS-R Agonist']","Phase 3",3,960,"Anticipated","2018-01-24","2022-04-05",{"$nulls":5},"A 46-week study to compare the efficacy of relamorelin with that of placebo in participants with diabetic gastroparesis (DG). At the end of the 40-week Treatment Period, participants will either continue on relamorelin or placebo for 6 additional weeks.",null,"A 46-week, Double-blind, Placebo-controlled, Phase 3 Study With a 6-week Randomized-withdrawal Period to Evaluate the Safety and Efficacy of Relamorelin in Patients With Diabetic Gastroparesis","RLM-MD-03","Gastroparesis\nDiabetes Mellitus","Paresis|Gastroparesis","Neurologic Manifestations|Gastrointestinal Diseases","Central Nervous System|Gastrointestinal","Experimental","Relamorelin 10 Î¼g|Relamorelin 10 Î¼g, followed by Placebo|Placebo, followed by Relamorelin 10 Î¼g","Relamorelin 10 Î¼g injected subcutaneously twice daily for 46 weeks.|Relamorelin 10 Î¼g injected subcutaneously twice daily for 40 weeks, followed by placebo injected twice daily for 6 weeks.|Placebo injected subcutaneously twice daily for 40 weeks, followed by Relamorelin 10 Î¼g injected twice daily for 6 weeks.","Drug","Relamorelin|Placebo","Relamorelin 10 Î¼g injected twice daily for 6, 40 or 46 weeks.|Placebo injected twice daily for 6 weeks or 40 weeks.",null,"Relamorelin 10 Î¼g|Relamorelin 10 Î¼g, followed by Placebo|Placebo, followed by Relamorelin 10 Î¼g","\n\n * Participants are eligible to be included in the study only if all the following criteria apply:\n * Participant met all inclusion/exclusion criteria of either Protocol RLM-MD-01 (NCT03285308) or Protocol RLM-MD-02 (NCT03426345) and successfully completed the study\n * Able to provide written informed consent (IC) prior to any study procedures and willing and able to comply with study procedures\n * In the opinion of the investigator, the participant demonstrated adequate compliance with the study procedures in Study RLM-MD-01 or RLM-MD-02\n\n","\n\n * Participants are excluded from the study if any of the following criteria apply:\n * Participant is not willing or able to abide by the restrictions regarding concomitant medicine use\n * Participant is planning to receive an investigational drug (other than study treatment) or investigational device at any time during Study RLM-MD-03\n * Participant has an unresolved adverse event (AE) or a clinically significant finding on physical examination, clinical laboratory test, or 12-lead electrocardiogram (ECG) that, in the investigator's opinion, would limit the participant's ability to participate in or complete the study\n * Any other reason that, in the investigator's opinion, would confound proper interpretation of the study or expose a participant to unacceptable risk, including renal, hepatic or cardiopulmonary disease",{"$nulls":4},"Actual","2018-02-05","Actual","Anticipated","2022-04-05","Anticipated","2018-02-01","2018-01-24","2018-02-01","2018-02-14","No","diabetic gastroparesis\nvomiting","Interventional","Treatment","Parallel Assignment","Triple (Participant, Care Provider, Investigator)","Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":19},"Diabetic Gastroparesis Symptom Severity Score (DGSSS) Week-12 Responder|Percentage of patients meeting the vomiting symptom responder criterion in each of the last 6 of the 12 weeks of treatment","Patients will assess severity of diabetic gastroparesis symptoms daily using an 11-point ordinal scale with 0 being least and 10 being the worst possible score. Patients will enter the score using an electronic diary.|Vomiting episodes will be patient-recorded daily using an electronic diary.","Baseline to Week 12","Nausea Week 12 Responder|Abdominal Pain Week 12 Responder|Bloating Week 12 Responder|Postprandial Fullness Week 12 Responder|DGSSS Week 40 Responder|DGSSS at Week 40|Vomiting Frequency at Week 40|Vomiting Week-40 Responder|DGSSS at Week 46|Number of Vomiting Episodes at Week 46|Number of Patients who experienced one or more Treatment Emergent Adverse Event (TEAE)","Nausea responder defined as a participant who has at least a 2-point improvement in the weekly symptom score at each of the last 6 weeks of the first 12 weeks of the 40-week Treatment Period. Nausea is assessed on an 11-point ordinal scale from 0 to 10, with 0 meaning no nausea, and 10 meaning the worst possible nausea.|Abdominal pain responder defined as a participant who has at least a 2-point improvement in the weekly symptom score at each of the last 6 weeks of the first 12 weeks of the 40-week Treatment Period. Abdominal Pain is assessed on an 11-point ordinal scale from 0 to 10, with 0 meaning no abdominal Pain, and 10 meaning the worst possible abdominal pain.|Bloating responder defined as a participant who has at least a 2-point improvement in the weekly symptom score at each of the last 6 weeks of the first 12 weeks of the 40-week Treatment Period. Bloating is assessed on an 11-point ordinal scale from 0 to 10, with 0 meaning no bloating, and 10 meaning the worst possible bloating.|Postprandial Fullness responder defined as a participant who has at least a 2-point improvement in the weekly symptom score at each of the last 6 weeks of the first 12 weeks of the 40-week Treatment Period.\n\nPostprandial Fullness is assessed on an 11-point ordinal scale from 0 to 10, with 0 meaning no feeling of fullness until finishing a meal, and 10 meaning felling full after only a few bites.|DGSSS responder defined as a participant who has at least a 10-point improvement in the DGSSS compared to baseline in each of the last 4 weeks of the 40-week Treatment Period.|Change from baseline to Week 40 in average weekly DGSSS. Average weekly scores are derived as the average of the weekly scores from the four weeks prior to Week 40 (Visit 7) in this study.|Change from baseline to Week 40 in average weekly number of vomiting episodes derived as the average of the weekly number of vomiting episodes during the four weeks prior to Week 40 (Visit 7) in this study.|Vomiting responder defined as a participant with zero weekly vomiting episodes during each of the last 4 weeks of the 40-week Treatment Period.|Change from baseline (CFB) to end of Randomized withdrawl period (RWP) in the average weekly DGSSS. Average weekly scores are derived as the average of the weekly scores from the six weeks of the RWP.|CFB to end of RWP in the average weekly number of vomiting episodes. Average weekly scores are derived as the average of the weekly number of vomiting episodes from the six weeks of the RWP.|The number of patients who experienced one or more TEAE during the 46 week treatment period.","Baseline to Week 12|Baseline to Week 40|Baseline to Week 46",{"$nulls":3},"North Little Rock, Arkansas, United States, 72117|Cutler Bay, Florida, United States, 33157 Florida Research Center, Inc.Miami, Florida, United States, 33174|Wyoming, Michigan, United States, 49519|Missoula, Montana, United States, 59808|Omaha, Nebraska, United States, 68114|Las Vegas, Nevada, United States, 89121 Palm Research CenterLas Vegas, Nevada, United States, 89148|Great Neck, New York, United States, 11023|Wilmington, North Carolina, United States, 28403 Trial Management Associates, LlcWinston-Salem, North Carolina, United States, 27103|Beavercreek, Ohio, United States, 45440 Endocrinology Research Associates, Inc.Columbus, Ohio, United States, 43201 Hometown Urgent Care And ResearchColumbus, Ohio, United States, 43214","Arkansas|Florida|Michigan|Montana|Nebraska|Nevada|New York|North Carolina|Ohio","United States","Arkansas Gastroenterology|American Research Institute, Inc|Gastroenterology Associates Of Western Michigan|Montana Medical Research|Diabetes And Endocrine Associates, Pc|Clinical Research Of South Nevada - Crosn|Long Island Gastrointestinal Research Group Llp|Trial Management Associates, Llc|Dayton Gastroenterology,Inc.",{"$nulls":3},"Wieslaw (Wes) Bochenek, MD, PhD","2018-02-14","2020-05-25T16:40:18.128","2020-05-26T17:10:42.972","NCT03420781"]
["5ecbf4f211702c1b1b916c2b","NCT03420781","2018-04-04","Allergan","AGN","Enrolling by invitation","A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis Study 03","Relamorelin","GHS-R Agonist","Yes","['Relamorelin']","Yes","['GHS-R Agonist']","Phase 3",3,960,"Anticipated","2018-01-24","2022-04-05",{"$nulls":5},"A 46-week study to compare the efficacy of relamorelin with that of placebo in participants with diabetic gastroparesis (DG). At the end of the 40-week Treatment Period, participants will either continue on relamorelin or placebo for 6 additional weeks.",null,"A 46-week, Double-blind, Placebo-controlled, Phase 3 Study With a 6-week Randomized-withdrawal Period to Evaluate the Safety and Efficacy of Relamorelin in Patients With Diabetic Gastroparesis","RLM-MD-03","Gastroparesis\nDiabetes Mellitus","Paresis|Gastroparesis","Neurologic Manifestations|Gastrointestinal Diseases","Central Nervous System|Gastrointestinal","Experimental","Relamorelin 10 Î¼g|Relamorelin 10 Î¼g, followed by Placebo|Placebo, followed by Relamorelin 10 Î¼g","Relamorelin 10 Î¼g injected subcutaneously twice daily for 46 weeks.|Relamorelin 10 Î¼g injected subcutaneously twice daily for 40 weeks, followed by placebo injected twice daily for 6 weeks.|Placebo injected subcutaneously twice daily for 40 weeks, followed by Relamorelin 10 Î¼g injected twice daily for 6 weeks.","Drug","Relamorelin|Placebo","Relamorelin 10 Î¼g injected twice daily for 6, 40 or 46 weeks.|Placebo injected twice daily for 6 weeks or 40 weeks.",null,"Relamorelin 10 Î¼g|Relamorelin 10 Î¼g, followed by Placebo|Placebo, followed by Relamorelin 10 Î¼g","\n\n * Participants are eligible to be included in the study only if all the following criteria apply:\n * Participant met all inclusion/exclusion criteria of either Protocol RLM-MD-01 (NCT03285308) or Protocol RLM-MD-02 (NCT03426345) and successfully completed the study\n * Able to provide written informed consent (IC) prior to any study procedures and willing and able to comply with study procedures\n * In the opinion of the investigator, the participant demonstrated adequate compliance with the study procedures in Study RLM-MD-01 or RLM-MD-02\n\n","\n\n * Participants are excluded from the study if any of the following criteria apply:\n * Participant is not willing or able to abide by the restrictions regarding concomitant medicine use\n * Participant is planning to receive an investigational drug (other than study treatment) or investigational device at any time during Study RLM-MD-03\n * Participant has an unresolved adverse event (AE) or a clinically significant finding on physical examination, clinical laboratory test, or 12-lead electrocardiogram (ECG) that, in the investigator's opinion, would limit the participant's ability to participate in or complete the study\n * Any other reason that, in the investigator's opinion, would confound proper interpretation of the study or expose a participant to unacceptable risk, including renal, hepatic or cardiopulmonary disease",{"$nulls":4},"Actual","2018-02-05","Actual","Anticipated","2022-04-05","Anticipated","2018-04-01","2018-01-24","2018-02-01","2018-04-03","No","diabetic gastroparesis\nvomiting","Interventional","Treatment","Parallel Assignment","Triple (Participant, Care Provider, Investigator)","Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":19},"Diabetic Gastroparesis Symptom Severity Score (DGSSS) Week-12 Responder|Percentage of patients meeting the vomiting symptom responder criterion in each of the last 6 of the 12 weeks of treatment","Patients will assess severity of diabetic gastroparesis symptoms daily using an 11-point ordinal scale with 0 being least and 10 being the worst possible score. Patients will enter the score using an electronic diary.|Vomiting episodes will be patient-recorded daily using an electronic diary.","Baseline to Week 12","Nausea Week 12 Responder|Abdominal Pain Week 12 Responder|Bloating Week 12 Responder|Postprandial Fullness Week 12 Responder|DGSSS Week 40 Responder|DGSSS at Week 40|Vomiting Frequency at Week 40|Vomiting Week-40 Responder|DGSSS at Week 46|Number of Vomiting Episodes at Week 46|Number of Patients who experienced one or more Treatment Emergent Adverse Event (TEAE)","Nausea responder defined as a participant who has at least a 2-point improvement in the weekly symptom score at each of the last 6 weeks of the first 12 weeks of the 40-week Treatment Period. Nausea is assessed on an 11-point ordinal scale from 0 to 10, with 0 meaning no nausea, and 10 meaning the worst possible nausea.|Abdominal pain responder defined as a participant who has at least a 2-point improvement in the weekly symptom score at each of the last 6 weeks of the first 12 weeks of the 40-week Treatment Period. Abdominal Pain is assessed on an 11-point ordinal scale from 0 to 10, with 0 meaning no abdominal Pain, and 10 meaning the worst possible abdominal pain.|Bloating responder defined as a participant who has at least a 2-point improvement in the weekly symptom score at each of the last 6 weeks of the first 12 weeks of the 40-week Treatment Period. Bloating is assessed on an 11-point ordinal scale from 0 to 10, with 0 meaning no bloating, and 10 meaning the worst possible bloating.|Postprandial Fullness responder defined as a participant who has at least a 2-point improvement in the weekly symptom score at each of the last 6 weeks of the first 12 weeks of the 40-week Treatment Period.\n\nPostprandial Fullness is assessed on an 11-point ordinal scale from 0 to 10, with 0 meaning no feeling of fullness until finishing a meal, and 10 meaning felling full after only a few bites.|DGSSS responder defined as a participant who has at least a 10-point improvement in the DGSSS compared to baseline in each of the last 4 weeks of the 40-week Treatment Period.|Change from baseline to Week 40 in average weekly DGSSS. Average weekly scores are derived as the average of the weekly scores from the four weeks prior to Week 40 (Visit 7) in this study.|Change from baseline to Week 40 in average weekly number of vomiting episodes derived as the average of the weekly number of vomiting episodes during the four weeks prior to Week 40 (Visit 7) in this study.|Vomiting responder defined as a participant with zero weekly vomiting episodes during each of the last 4 weeks of the 40-week Treatment Period.|Change from baseline (CFB) to end of Randomized withdrawl period (RWP) in the average weekly DGSSS. Average weekly scores are derived as the average of the weekly scores from the six weeks of the RWP.|CFB to end of RWP in the average weekly number of vomiting episodes. Average weekly scores are derived as the average of the weekly number of vomiting episodes from the six weeks of the RWP.|The number of patients who experienced one or more TEAE during the 46 week treatment period.","Baseline to Week 12|Baseline to Week 40|Baseline to Week 46",{"$nulls":3},"North Little Rock, Arkansas, United States, 72117|Cutler Bay, Florida, United States, 33157 Hometown Urgent Care And ResearchInverness, Florida, United States, 34452 Advanced Medical Research InstituteMiami, Florida, United States, 33174 Florida Research Center, Inc.Miami, Florida, United States, 33174|Buford, Georgia, United States, 30519|Bastrop, Louisiana, United States, 71220|Wyoming, Michigan, United States, 49519|Missoula, Montana, United States, 59808|Las Vegas, Nevada, United States, 89121 Palm Research CenterLas Vegas, Nevada, United States, 89148|Great Neck, New York, United States, 11023|Wilmington, North Carolina, United States, 28403 Trial Management Associates, LlcWinston-Salem, North Carolina, United States, 27103|Beavercreek, Ohio, United States, 45440 Endocrinology Research Associates, Inc.Columbus, Ohio, United States, 43201 Hometown Urgent Care And ResearchColumbus, Ohio, United States, 43214","Arkansas|Florida|Georgia|Louisiana|Michigan|Montana|Nevada|New York|North Carolina|Ohio","United States","Arkansas Gastroenterology|American Research Institute, Inc|Gwinnett Research Institute|The Center For Clinical Research|Gastroenterology Associates Of Western Michigan|Montana Medical Research|Clinical Research Of South Nevada - Crosn|Long Island Gastrointestinal Research Group Llp|Trial Management Associates, Llc|Dayton Gastroenterology,Inc.",{"$nulls":3},"Wieslaw (Wes) Bochenek, MD, PhD","2018-04-03","2020-05-25T16:40:18.130","2020-05-26T17:10:42.972","NCT03420781"]
["5ecbf4f2e2561b1b11905f19","NCT03420781","2018-05-15","Allergan","AGN","Enrolling by invitation","A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis Study 03","Relamorelin","GHS-R Agonist","Yes","['Relamorelin']","Yes","['GHS-R Agonist']","Phase 3",3,960,"Anticipated","2018-01-24","2022-04-05",{"$nulls":5},"A 46-week study to compare the efficacy of relamorelin with that of placebo in participants with diabetic gastroparesis (DG). At the end of the 40-week Treatment Period, participants will either continue on relamorelin or placebo for 6 additional weeks.",null,"A 46-week, Double-blind, Placebo-controlled, Phase 3 Study With a 6-week Randomized-withdrawal Period to Evaluate the Safety and Efficacy of Relamorelin in Patients With Diabetic Gastroparesis","RLM-MD-03","Gastroparesis\nDiabetes Mellitus","Paresis|Gastroparesis","Neurologic Manifestations|Gastrointestinal Diseases","Central Nervous System|Gastrointestinal","Experimental","Relamorelin 10 Î¼g|Relamorelin 10 Î¼g, followed by Placebo|Placebo, followed by Relamorelin 10 Î¼g","Relamorelin 10 Î¼g injected subcutaneously twice daily for 46 weeks.|Relamorelin 10 Î¼g injected subcutaneously twice daily for 40 weeks, followed by placebo injected twice daily for 6 weeks.|Placebo injected subcutaneously twice daily for 40 weeks, followed by Relamorelin 10 Î¼g injected twice daily for 6 weeks.","Drug","Relamorelin|Placebo","Relamorelin 10 Î¼g injected twice daily for 6, 40 or 46 weeks.|Placebo injected twice daily for 6 weeks or 40 weeks.",null,"Relamorelin 10 Î¼g|Relamorelin 10 Î¼g, followed by Placebo|Placebo, followed by Relamorelin 10 Î¼g","\n\n * Participants are eligible to be included in the study only if all the following criteria apply:\n * Participant met all inclusion/exclusion criteria of either Protocol RLM-MD-01 (NCT03285308) or Protocol RLM-MD-02 (NCT03426345) and successfully completed the study\n * Able to provide written informed consent (IC) prior to any study procedures and willing and able to comply with study procedures\n * In the opinion of the investigator, the participant demonstrated adequate compliance with the study procedures in Study RLM-MD-01 or RLM-MD-02\n\n","\n\n * Participants are excluded from the study if any of the following criteria apply:\n * Participant is not willing or able to abide by the restrictions regarding concomitant medicine use\n * Participant is planning to receive an investigational drug (other than study treatment) or investigational device at any time during Study RLM-MD-03\n * Participant has an unresolved adverse event (AE) or a clinically significant finding on physical examination, clinical laboratory test, or 12-lead electrocardiogram (ECG) that, in the investigator's opinion, would limit the participant's ability to participate in or complete the study\n * Any other reason that, in the investigator's opinion, would confound proper interpretation of the study or expose a participant to unacceptable risk, including renal, hepatic or cardiopulmonary disease",{"$nulls":4},"Actual","2018-02-05","Actual","Anticipated","2022-04-05","Anticipated","2018-05-01","2018-01-24","2018-02-01","2018-05-14","No","diabetic gastroparesis\nvomiting","Interventional","Treatment","Parallel Assignment","Triple (Participant, Care Provider, Investigator)","Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":19},"Diabetic Gastroparesis Symptom Severity Score (DGSSS) Week-12 Responder|Percentage of patients meeting the vomiting symptom responder criterion in each of the last 6 of the 12 weeks of treatment","Patients will assess severity of diabetic gastroparesis symptoms daily using an 11-point ordinal scale with 0 being least and 10 being the worst possible score. Patients will enter the score using an electronic diary.|Vomiting episodes will be patient-recorded daily using an electronic diary.","Baseline to Week 12","Nausea Week 12 Responder|Abdominal Pain Week 12 Responder|Bloating Week 12 Responder|Postprandial Fullness Week 12 Responder|DGSSS Week 40 Responder|DGSSS at Week 40|Vomiting Frequency at Week 40|Vomiting Week-40 Responder|DGSSS at Week 46|Number of Vomiting Episodes at Week 46|Number of Patients who experienced one or more Treatment Emergent Adverse Event (TEAE)","Nausea responder defined as a participant who has at least a 2-point improvement in the weekly symptom score at each of the last 6 weeks of the first 12 weeks of the 40-week Treatment Period. Nausea is assessed on an 11-point ordinal scale from 0 to 10, with 0 meaning no nausea, and 10 meaning the worst possible nausea.|Abdominal pain responder defined as a participant who has at least a 2-point improvement in the weekly symptom score at each of the last 6 weeks of the first 12 weeks of the 40-week Treatment Period. Abdominal Pain is assessed on an 11-point ordinal scale from 0 to 10, with 0 meaning no abdominal Pain, and 10 meaning the worst possible abdominal pain.|Bloating responder defined as a participant who has at least a 2-point improvement in the weekly symptom score at each of the last 6 weeks of the first 12 weeks of the 40-week Treatment Period. Bloating is assessed on an 11-point ordinal scale from 0 to 10, with 0 meaning no bloating, and 10 meaning the worst possible bloating.|Postprandial Fullness responder defined as a participant who has at least a 2-point improvement in the weekly symptom score at each of the last 6 weeks of the first 12 weeks of the 40-week Treatment Period.\n\nPostprandial Fullness is assessed on an 11-point ordinal scale from 0 to 10, with 0 meaning no feeling of fullness until finishing a meal, and 10 meaning felling full after only a few bites.|DGSSS responder defined as a participant who has at least a 10-point improvement in the DGSSS compared to baseline in each of the last 4 weeks of the 40-week Treatment Period.|Change from baseline to Week 40 in average weekly DGSSS. Average weekly scores are derived as the average of the weekly scores from the four weeks prior to Week 40 (Visit 7) in this study.|Change from baseline to Week 40 in average weekly number of vomiting episodes derived as the average of the weekly number of vomiting episodes during the four weeks prior to Week 40 (Visit 7) in this study.|Vomiting responder defined as a participant with zero weekly vomiting episodes during each of the last 4 weeks of the 40-week Treatment Period.|Change from baseline (CFB) to end of Randomized withdrawl period (RWP) in the average weekly DGSSS. Average weekly scores are derived as the average of the weekly scores from the six weeks of the RWP.|CFB to end of RWP in the average weekly number of vomiting episodes. Average weekly scores are derived as the average of the weekly number of vomiting episodes from the six weeks of the RWP.|The number of patients who experienced one or more TEAE during the 46 week treatment period.","Baseline to Week 12|Baseline to Week 40|Baseline to Week 46",{"$nulls":3},{"$cut":{"chars":20208,"head":"Kingswood, New South Wales, Australia, 2747|Woolloongabba, Queensland, Australia, 4102|Adelaide, South|Melbourne, Victoria, Australia, 3004 Royal Melbourne HospitalParkville, Victoria, Australia, 3050|Klagenfurt, Austria, 9020 Privatklinik Wehrle-DiakonissenSalzburg, Austria, 5020 OÃ£Æ’Ã¢Â¶. Gesundheits- Und Spitals-Ag/Lkh SteyrSteyr, Austria, 4400 Krankenanstalt Rudolfstiftung WienVienna, Austria, 1030 Kh HietzingVienna, Austria, 1130|Saint Stefan, Steiermark, Austria, 8511|Innsbruck, Tirol, Austria, A-6020|Feldkirch`, Vorarlberg, Austria, 6807|Edegem, Antwerp, Belgium, 2650|Jette, Brussel, Belgium, 1090|Brugge, West-Vlaanderen, Belgium, 8310|Byala, Ruse, Bulgaria, 7100|Plovdiv, Bulgaria, 4002 Medical Center Asklepion - Humane Medicine Research EoodSofia, Bulgaria, 1303 Alexandrovska University HospitalSofia, Bulgaria, 1431|Calgary, Alberta, Canada, T2N 2T9 Alberta Diabetes InstituteEdmonton, Alberta, Canada, T6G 2E1 The Bailey ClinicRed Deer, Alberta, Canada, T4N 6V7|Vancouver, British Columbia, Canada, V5Z 1M9|St. John'S, Newfoundland And Labrador, Canada, A1B 3V6|Bridgewater, Nova Scotia, Canada, B4V 2V6|Ottawa, Ontario, Canada, K1H 7W9 Sunnybrook Health Science CentreToronto, Ontario, Canada, M4N 3M5 Toronto Western Hospital, University Health NetworkToronto, Ontario, Canada, M5T 2S8 Toronto Liver CentreToronto, Ontario, Canada, M6H 3M1 Dr. Anil K. Gupta Medicine Professional CorporationToronto, Ontario, Canada, M9V 4B4 Toronto Digestive Disease Associates, Inc.Vaughan, Ontario, Canada, L4L 4Y7|Greenfield Park, Quebec, Canada, J4V 2H1 Recherche Gcp ResearchMontreal, Quebec, Canada, H1M 1B1 Centre Hospitalier De L'Universite De Montreal - ChumMontreal, Quebec, Canada, H2X 0A9|Aalborg, Denmark, 9000 Mea KfaAarhus, Denmark, 8000|Hellerup, Copenhagen, Denmark, 2900 Gastroenheden, Hvidovre HospitalHvidovre, Copenhagen, Denmark, 2650|Pessac, Gironde, France, 33604|Coombes, France, 92700 Corbeil EssonnesCorbeil Essonnes Cedex, France, 91106 GrenobleGrenoble, France, 38043 Hospices Civils De Lyon - HÃ£Â´Pital Edouard HerrriotLyon Cedex 03, France, 69437 Chu NantesNantes Cedex 1, France, 44093 Chu De PoitiersPoitiers, France, 86021 Hopital Charles NicolleRouen Cedex, France, 76031 Chru NancyVandoeuvre-LÃ£Â¨S-Nancy, France, 54500|Karlsruhe, Baden-WÃ£Â¼Rttemberg, Germany, 76137 Praxis Dr. Etzrodt-Walter Und KollegenUlm, Baden-WÃ£Â¼Rttemberg, Germany, 89073|Bad Berleburg, Germany, 57319 Clinical Research UnitGiessen, Germany, 32392 Klinische Forschung Hamburg GmbhHamburg, Germany, 20253 Clinical Research HamburgHamburg, Germany, 22143 Israelitisches KrankenhausHamburg, Germany, 22297 Crh Clinic SiloahHannover, Germany, 30459|Schwerin, Mecklenburg Vorpommern, Germany, 19055|Hannover, Niedersachsen, Germany, 30159|BÃ£Â¶Hlen, Saxony, Germany, 4564 Klinische Forschung Dresden GmbhDresden, Saxony, Germany, 1309|Szeged, CsonfrÃ£Â¡D, Hungary, 6720|Eger, Heves, Hungary, H-3300|Budapest, Hungary, H-1088 StrÃ£Æ’Ã¢Â¡Zshegy MedicinaBudapest, Hungary, H1171 Coromed SmoPecs, Hungary, 7623 Hetenyi Geza HospitalSzolnok MagyarorszÃ£Æ’Ã¢Â¡G, Hungary, H-5004|Zalaegerszeg, Zala, Hungary, H-8900|Ahmedabad, Gujarat, India, 380007|Pune, Maharashtra, India, 411001|Jaipur, Rajasthan, India, 302017|Hyderabad, Telangana, India, 500072|Lucknow, Uttar Prandesh, India, 226003|Kolkata, West Bengal, India, 700020|Beer Sheba, Israel, 85025 Bnei-Zion McHaifa, Israel, 31948 The E. Wolfson Medical CenterHolon, Israel, 58100 Digestive Diseases InstituteJerusalem, Israel, 91031 Gastroenterology InstitutePetach Tikva, Israel, 49100 Endocrinology & Diabetes CenterSafed, Israel, 13100 Gastroenterology InstituteTel Aviv, Israel, 64239|San Donato Milanese, Milan, Italy, 20097|Asti, Italy, 14100 University Of BariBari, Italy, 70121 Universita Magna Graecia Di CatanzaroCatanzaro, Italy, 88100 Ao Universitaria San Martino - IrccsGenova, Italy, 16132 Federico Ii University Of NaplesNapoli, Italy, 80131 Azienda Ospedale-UniversitÃ£ PadovaPadova, Italy, 35128 Irccs S.Matteo Hospital Foundation, University Of PaviaPavia, Italy, 27100 University Of Pisa - Cisanello HospitalPisa"}},"Alabama|Arizona|Arkansas|California|Colorado|Connecticut|Florida|Georgia|Idaho|Illinois|Indiana|Iowa|Kansas|Kentucky|Louisiana|Maryland|Massachusetts|Michigan|Missouri|Montana|Nebraska|Nevada|New Jersey|New Mexico|New York|North Carolina|Ohio|Oklahoma|Oregon|Pennsylvania|Rhode Island|South Carolina|South Dakota|Tennessee|Texas|Utah|Virginia","Australia|Austria|Belgium|Bulgaria|Canada|Denmark|France|Germany|Hungary|India|Israel|Italy|Latvia|Malaysia|Philippines|Poland|Romania|South Africa|Spain|Thailand|Ukraine|United Kingdom|United States","New South Wales Nepean Hospital|Queensland Princess Alexandra Hospital|Royal Adelaide Hospital|Victoria The Alfred Hospital|Klinikum Klagenfurt Am WÃ£Â¶Rthersee|Steiermark Ordination|Tirol Medizinische Universitat Innsbruck|Vorarlberg Vivit Institute, Am Lkh Feldkirch|Antwerp Universitair Ziekenhuis Antwerpen, Gastro-Enterologie,|Brussel Uz Brussel|West-Vlaanderen Az Sint Lucas Brugge|Ruse Mhat Yuliya Vrevska Byala|Umhat - Kaspela- Eood|Alberta University Of Calgary|British Columbia Gordon And Leslie Diamond Health Care Centre|Newfoundland And Labrador Eastern Health|Nova Scotia South Shore Medical Arts|Ontario The Ottawa Hospital|Quebec Cisss De La Monteregie-Centre|Aalborg University Hospital|Copenhagen Gentofte Hospital|Gironde Chu De Bordeaux - HÃ£Â´Pital Haut-LÃ£Â©VÃ£Âªque|Hopital Louis Mourier, Service D'Hepato Gastro-Enterologie|Baden-WÃ£Â¼Rttemberg Klinische Forschung Karlsruhe Gmbh|Diabetologische Schwerpunktpraxis|Mecklenburg Vorpommern Klinische Forschung Schwerin Gmbh|Niedersachsen Klinische Forschung Hannover-Mitte Gmbh|Saxony Studienzentrum Schwittay|CsonfrÃ£Â¡D First Department Of Medicine, University Of Szeged|Heves Markhot Ferenc Oktatokorhaz Es Rendelointezet|Semmelweis University|Zala Zala Megyei Szent Rafael Korhaz|Gujarat Dr. Jivraj Mehta Smarak Health Foundation|Maharashtra Grant Medical Foundation Ruby Hall Clinic|Rajasthan Eternal Hospital, Unit Of Eternal Heart Care Centre And Research Institute Pvt. Ltd.|Telangana Kumudini Devi Diabetes Research Center|Uttar Prandesh M.V Hospital And Research Centre|West Bengal Ipgme&R And Sskm Hospital|Soroka University Medical Center|Milan Irccs Policlinico San Donato|Ospedale Cardinal Massaia|Sicily Azienda Ospedaliera Rilievo Nazionale Alta Specialita (Arnas) Garibaldi|Kraslavas Nov. Ogorelova Jelena Gp|Polana-D, Llc|Kedah Hospital Sultanah Bahiyah|Iloilo West Visayas State University Medical Center|Manila Doctors Hospital|Metro Manila St. Luke's Medical Center|Ncr Ospital Ng Makati|Kuj-Pom Vitamed Galaj I Cichomski Sp.J.|Lubelskie ZamoÃ¥>Ã„â€¡|Malopolska Centermed Krakow Ltd|Mazowieckie Oddzial Gastroenterologii Mazowieckie Centrum Rehabilitacji Stocer Sp. Z O.O.|MaÃ£â€¦Ã‚â‚¬Å opolska Specjalistyczny Gabinet Neurologiczny Marta Banach|Podlaski Diabet-Med|Pomorskie Endoskopia Sp. Z O.O.|University Hospital BiaÃ£â€¦Ã‚â‚¬Å ystok|Warmia-Mazury State Hospital|Sana Medical Center|, Gauteng Wits Clinical Research|, Western Cape Endocare|Synexus Helderberg Clinical Research Centre|Hospital Universitario 12 De Octubre|Phramongkutklao Hospital|\"|Chernihiv City Hospital No 2 Of Chernihiv City Council|Odesa Region Odesa Regional Clinical Hospital|On The Base Of Pirogov National Medical University|Zaporizhzhia Region Municipal Institution City Hospital No. 7|, East Midland Queens Medical Centre|, Greater Manchester Mac Clinical Research Manchester|, Lancashire Royal Oldham Hospital|, London St George's Hospital|, Staffordshire Mac Research, Exchange House|, West Midlands Royal Wolverhampton Nhs Trust|, West Yorkshire Mac Clinical Research, Monarch House|Mac Research|North Alabama Research Center, Llc|Del Sol Research Management, Llc|Chi St. Vincent's Gastroenterology: John Tyler Baber, Md|Hope Clinical Research|Denver Esophageal And Stomach Center|Connecticut Clinical Research Foundation|Innovative Research Of West Fl, Inc.|Atlanta Diabetes Associates|Rocky Mountain Diabetes And Osteoporosis Center, Pa|Southwest Gastroenterology|Medisphere Medical Research Center, Llc|University Of Iowa Hospitals And Clinics|University Of Kansas Medical Center|University Of Louisville|The Center For Clinical Research|Metropolitan Gastroenterology Group Pc, Chevy Chase Clinical Research|Commonwealth Clinical Studies, Pllc.|Biocon Clinical Research, Llc|Washington University In St. Louis|Montana Medical Research|Diabetes And Endocrine Associates, P.C.|Clinical Research Of South Nevada - Crosn|Aga Clinical Research Associates Llc|Lovelace Scientific Resources, Inc.|Long Island Gastrointestinal Research Group Llp|Asheville Gastroenterology Associates|Dayton Gastroenterology,Inc.|Digestive Disease Specialists Inc|Northwest Gastroenterology Clinic, Llc|Family Medical Associates, Research Department|Partners In Clinical Research, Llc|Clinical Trials Of South Carolina|Health Concepts|Wr-Clinsearch, Llc|Texas Clinical Research Institute, Llc|Advanced Research Institute, Inc.|Blue Ridge Medical Research",{"$nulls":3},"Wieslaw (Wes) Bochenek, MD, PhD","2018-05-14","2020-05-25T16:40:18.339","2020-05-26T17:10:42.972","NCT03420781"]
["5ecbf4f2feab101b15530a4e","NCT03420781","2018-06-26","Allergan","AGN","Enrolling by invitation","A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis Study 03","Relamorelin","GHS-R Agonist","Yes","['Relamorelin']","Yes","['GHS-R Agonist']","Phase 3",3,960,"Anticipated","2018-01-24","2020-12-06",{"$nulls":5},"A 46-week study to compare the efficacy of relamorelin with that of placebo in participants with diabetic gastroparesis (DG). At the end of the 40-week Treatment Period, participants will either continue on relamorelin or placebo for 6 additional weeks.",null,"A 46-week, Double-blind, Placebo-controlled, Phase 3 Study With a 6-week Randomized-withdrawal Period to Evaluate the Safety and Efficacy of Relamorelin in Patients With Diabetic Gastroparesis","RLM-MD-03","Gastroparesis\nDiabetes Mellitus","Paresis|Gastroparesis","Neurologic Manifestations|Gastrointestinal Diseases","Central Nervous System|Gastrointestinal","Experimental","Relamorelin 10 Î¼g|Relamorelin 10 Î¼g, followed by Placebo|Placebo, followed by Relamorelin 10 Î¼g","Relamorelin 10 Î¼g injected subcutaneously twice daily for 46 weeks.|Relamorelin 10 Î¼g injected subcutaneously twice daily for 40 weeks, followed by placebo injected twice daily for 6 weeks.|Placebo injected subcutaneously twice daily for 40 weeks, followed by Relamorelin 10 Î¼g injected twice daily for 6 weeks.","Drug","Relamorelin|Placebo","Relamorelin 10 Î¼g injected twice daily for 6, 40 or 46 weeks.|Placebo injected twice daily for 6 weeks or 40 weeks.",null,"Relamorelin 10 Î¼g|Relamorelin 10 Î¼g, followed by Placebo|Placebo, followed by Relamorelin 10 Î¼g","\n\n * Participants are eligible to be included in the study only if all the following criteria apply:\n * Participant met all inclusion/exclusion criteria of either Protocol RLM-MD-01 (NCT03285308) or Protocol RLM-MD-02 (NCT03426345) and successfully completed the study\n * Able to provide written informed consent (IC) prior to any study procedures and willing and able to comply with study procedures\n * In the opinion of the investigator, the participant demonstrated adequate compliance with the study procedures in Study RLM-MD-01 or RLM-MD-02\n\n","\n\n * Participants are excluded from the study if any of the following criteria apply:\n * Participant is not willing or able to abide by the restrictions regarding concomitant medicine use\n * Participant is planning to receive an investigational drug (other than study treatment) or investigational device at any time during Study RLM-MD-03\n * Participant has an unresolved adverse event (AE) or a clinically significant finding on physical examination, clinical laboratory test, or 12-lead electrocardiogram (ECG) that, in the investigator's opinion, would limit the participant's ability to participate in or complete the study\n * Any other reason that, in the investigator's opinion, would confound proper interpretation of the study or expose a participant to unacceptable risk, including renal, hepatic or cardiopulmonary disease",{"$nulls":4},"Actual","2018-02-05","Actual","Anticipated","2020-12-06","Anticipated","2018-06-01","2018-01-24","2018-02-01","2018-06-22","No","diabetic gastroparesis\nvomiting","Interventional","Treatment","Parallel Assignment","Triple (Participant, Care Provider, Investigator)","Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":19},"Diabetic Gastroparesis Symptom Severity Score (DGSSS) Week-12 Responder|Percentage of patients meeting the vomiting symptom responder criterion in each of the last 6 of the 12 weeks of treatment","Patients will assess severity of diabetic gastroparesis symptoms daily using an 11-point ordinal scale with 0 being least and 10 being the worst possible score. Patients will enter the score using an electronic diary.|Vomiting episodes will be patient-recorded daily using an electronic diary.","Baseline to Week 12","Nausea Week 12 Responder|Abdominal Pain Week 12 Responder|Bloating Week 12 Responder|Postprandial Fullness Week 12 Responder|DGSSS Week 40 Responder|DGSSS at Week 40|Vomiting Frequency at Week 40|Vomiting Week-40 Responder|DGSSS at Week 46|Number of Vomiting Episodes at Week 46|Number of Patients who experienced one or more Treatment Emergent Adverse Event (TEAE)","Nausea responder defined as a participant who has at least a 2-point improvement in the weekly symptom score at each of the last 6 weeks of the first 12 weeks of the 40-week Treatment Period. Nausea is assessed on an 11-point ordinal scale from 0 to 10, with 0 meaning no nausea, and 10 meaning the worst possible nausea.|Abdominal pain responder defined as a participant who has at least a 2-point improvement in the weekly symptom score at each of the last 6 weeks of the first 12 weeks of the 40-week Treatment Period. Abdominal Pain is assessed on an 11-point ordinal scale from 0 to 10, with 0 meaning no abdominal Pain, and 10 meaning the worst possible abdominal pain.|Bloating responder defined as a participant who has at least a 2-point improvement in the weekly symptom score at each of the last 6 weeks of the first 12 weeks of the 40-week Treatment Period. Bloating is assessed on an 11-point ordinal scale from 0 to 10, with 0 meaning no bloating, and 10 meaning the worst possible bloating.|Postprandial Fullness responder defined as a participant who has at least a 2-point improvement in the weekly symptom score at each of the last 6 weeks of the first 12 weeks of the 40-week Treatment Period.\n\nPostprandial Fullness is assessed on an 11-point ordinal scale from 0 to 10, with 0 meaning no feeling of fullness until finishing a meal, and 10 meaning felling full after only a few bites.|DGSSS responder defined as a participant who has at least a 10-point improvement in the DGSSS compared to baseline in each of the last 4 weeks of the 40-week Treatment Period.|Change from baseline to Week 40 in average weekly DGSSS. Average weekly scores are derived as the average of the weekly scores from the four weeks prior to Week 40 (Visit 7) in this study.|Change from baseline to Week 40 in average weekly number of vomiting episodes derived as the average of the weekly number of vomiting episodes during the four weeks prior to Week 40 (Visit 7) in this study.|Vomiting responder defined as a participant with zero weekly vomiting episodes during each of the last 4 weeks of the 40-week Treatment Period.|Change from baseline (CFB) to end of Randomized withdrawl period (RWP) in the average weekly DGSSS. Average weekly scores are derived as the average of the weekly scores from the six weeks of the RWP.|CFB to end of RWP in the average weekly number of vomiting episodes. Average weekly scores are derived as the average of the weekly number of vomiting episodes from the six weeks of the RWP.|The number of patients who experienced one or more TEAE during the 46 week treatment period.","Baseline to Week 12|Baseline to Week 40|Baseline to Week 46",{"$nulls":3},{"$cut":{"chars":20568,"head":"Kingswood, New South Wales, Australia, 2747|Woolloongabba, Queensland, Australia, 4102|Adelaide, South|Melbourne, Victoria, Australia, 3004 Royal Melbourne HospitalParkville, Victoria, Australia, 3050|Klagenfurt, Austria, 9020 Privatklinik Wehrle-DiakonissenSalzburg, Austria, 5020 OÃ£Æ’Ã¢Â¶. Gesundheits- Und Spitals-Ag/Lkh SteyrSteyr, Austria, 4400 Krankenanstalt Rudolfstiftung WienVienna, Austria, 1030 Kh HietzingVienna, Austria, 1130|Sankt Stefan Ob Stainz, Styria, Austria, 8511|Innsbruck, Tirol, Austria, A-6020|Feldkirch`, Vorarlberg, Austria, 6807|Edegem, Antwerp, Belgium, 2650|Jette, Brussel, Belgium, 1090|Brugge, West-Vlaanderen, Belgium, 8310|FlorianÃ³polis, Santa Catarina, Brazil, 88015-230|Byala, Ruse, Bulgaria, 7100|Plovdiv, Bulgaria, 4002 Medical Center Asklepion - Humane Medicine Research EoodSofia, Bulgaria, 1303 Alexandrovska University HospitalSofia, Bulgaria, 1431|Calgary, Alberta, Canada, T2N 2T9 Alberta Diabetes InstituteEdmonton, Alberta, Canada, T6G 2E1 The Bailey ClinicRed Deer, Alberta, Canada, T4N 6V7|Vancouver, British Columbia, Canada, V5Z 1M9|St. John'S, Newfoundland And Labrador, Canada, A1B 3V6|Bridgewater, Nova Scotia, Canada, B4V 2V6|Ottawa, Ontario, Canada, K1H 7W9 Sunnybrook Health Science CentreToronto, Ontario, Canada, M4N 3M5 Toronto Western Hospital, University Health NetworkToronto, Ontario, Canada, M5T 2S8 Toronto Liver CentreToronto, Ontario, Canada, M6H 3M1 Dr. Anil K. Gupta Medicine Professional CorporationToronto, Ontario, Canada, M9V 4B4 Toronto Digestive Disease Associates, Inc.Vaughan, Ontario, Canada, L4L 4Y7|Greenfield Park, Quebec, Canada, J4V 2H1 Recherche Gcp ResearchMontreal, Quebec, Canada, H1M 1B1 Centre Hospitalier De L'Universite De Montreal - ChumMontreal, Quebec, Canada, H2X 0A9|Medellin, Antioquia, Colombia, 050034 Rodrigo Botero S.A.S.MedellÃ­n, Antioquia, Colombia, 050030|BogotÃ¡, Distrito Capital De BogotÃ¡, Colombia, 110221 Endocare Ltda.BogotÃ¡, Distrito Capital De BogotÃ¡, Colombia, 111111 AsociaciÃ³n Colombiana De DiabetesTeusaquillo, Distrito Capital De BogotÃ¡, Colombia, 111311|Villavicencio, Meta, Colombia, 500001|Pereira, Risaralda, Colombia, 660002|Cali, Valle Del Cauca, Colombia, 760042 Ips Centro Medico Julian Coronel S.ASantiago De Cali, Valle Del Cauca, Colombia, 760035|Aalborg, Denmark, 9000 Mea KfaAarhus, Denmark, 8000|Hellerup, Copenhagen, Denmark, 2900 Gastroenheden, Hvidovre HospitalHvidovre, Copenhagen, Denmark, 2650|Corbeil Essonnes Cedex, France, 91106 GrenobleGrenoble, France, 38043 Hospices Civils De Lyon - HÃ£Â´Pital Edouard HerrriotLyon Cedex 03, France, 69437 Chu NantesNantes Cedex 1, France, 44093 Chu De PoitiersPoitiers, France, 86021 Hopital Charles NicolleRouen Cedex, France, 76031|Pessac, Gironde, France, 33604|VandÅ“uvre-LÃ¨s-Nancy, Grand Est, France, 54500|Colombes, ÃŽle-De-|Karlsruhe, Baden-WÃ£Â¼Rttemberg, Germany, 76137 Praxis Dr. Etzrodt-Walter Und KollegenUlm, Baden-WÃ£Â¼Rttemberg, Germany, 89073|Bad Berleburg, Germany, 57319 Clinical Research UnitGiessen, Germany, 32392 Klinische Forschung Hamburg GmbhHamburg, Germany, 20253 Clinical Research HamburgHamburg, Germany, 22143 Israelitisches KrankenhausHamburg, Germany, 22297 Crh Clinic SiloahHannover, Germany, 30459|Schwerin, Mecklenburg Vorpommern, Germany, 19055|Hannover, Niedersachsen, Germany, 30159|BÃ¶hlen, Saxony, Germany, 4564 Klinische Forschung Dresden GmbhDresden, Saxony, Germany, 1309|Szeged, CsonfrÃ£Â¡D, Hungary, 6720|Eger, Heves, Hungary, H-3300|Szolnok, JÃ¡sz-Nagykun-Szolnok, Hungary, H-5004|Budapest, Hungary, H-1088 StrÃ£Æ’Ã¢Â¡Zshegy MedicinaBudapest, Hungary, H1171 Coromed SmoPecs, Hungary, 7623|Zalaegerszeg, Zala, Hungary, H-8900|Ahmedabad, Gujarat, India, 380007|Pune, Maharashtra, India, 411001|Jaipur, Rajasthan, India, 302017|Hyderabad, Telangana, India, 500072|Lucknow, Uttar Prandesh, India, 226003|Kolkata, West Bengal, India, 700020|Beer Sheba, Israel, 85025 Bnei-Zion McHaifa, Israel, 31948 The E. Wolfson Medical CenterHolon, Israel, 58100 Digestive Diseases InstituteJerusalem, Israel, 91031 Gastroenterology InstitutePetach Tikva, Israel, 49100 Endocrinolo"}},"Alabama|Arizona|Arkansas|California|Colorado|Connecticut|Florida|Georgia|Idaho|Illinois|Indiana|Iowa|Kansas|Kentucky|Louisiana|Maryland|Massachusetts|Michigan|Missouri|Montana|Nebraska|Nevada|New Jersey|New Mexico|New York|North Carolina|Ohio|Oklahoma|Oregon|Pennsylvania|Rhode Island|South Carolina|South Dakota|Tennessee|Texas|Utah|Virginia","Australia|Austria|Belgium|Brazil|Bulgaria|Canada|Colombia|Denmark|France|Germany|Hungary|India|Israel|Italy|Latvia|Malaysia|Mexico|Philippines|Poland|Romania|South Africa|Spain|Thailand|Ukraine|United Kingdom|United States","New South Wales Nepean Hospital|Queensland Princess Alexandra Hospital|Royal Adelaide Hospital|Victoria The Alfred Hospital|Klinikum Klagenfurt Am WÃ£Â¶Rthersee|Styria Ordination|Tirol Medizinische Universitat Innsbruck|Vorarlberg Vivit Institute, Am Lkh Feldkirch|Antwerp Universitair Ziekenhuis Antwerpen, Gastro-Enterologie,|Brussel Uz Brussel|West-Vlaanderen Az Sint Lucas Brugge|Santa Catarina Noova|Ruse Mhat Yuliya Vrevska Byala|Umhat - Kaspela- Eood|Alberta University Of Calgary|British Columbia Gordon And Leslie Diamond Health Care Centre|Newfoundland And Labrador Eastern Health|Nova Scotia South Shore Medical Arts|Ontario The Ottawa Hospital|Quebec Cisss De La Monteregie-Centre|Antioquia Centro Cardiovascular Colombiano ClÃ­nica Santa MarÃ­a|Distrito Capital De BogotÃ¡ Medplus Mp|Meta Clinica Meta|Risaralda Fundacion Centro De Investigaciones Clinicas Cardiomet|Valle Del Cauca Centro Medico Imbanaco De Cali S.A.|Aalborg University Hospital|Copenhagen Gentofte Hospital|Corbeil Essonnes|Gironde Chu De Bordeaux - HÃ£Â´Pital Haut-LÃ£Â©VÃ£Âªque|Grand Est Chru Nancy|Hopital Louis Mourier, Service D'Hepato Gastro-Enterologie|Baden-WÃ£Â¼Rttemberg Klinische Forschung Karlsruhe Gmbh|Diabetologische Schwerpunktpraxis|Mecklenburg Vorpommern Klinische Forschung Schwerin Gmbh|Niedersachsen Klinische Forschung Hannover-Mitte Gmbh|Saxony Studienzentrum Schwittay|CsonfrÃ£Â¡D First Department Of Medicine, University Of Szeged|Heves Markhot Ferenc Oktatokorhaz Es Rendelointezet|JÃ¡sz-Nagykun-Szolnok Hetenyi Geza Hospital|Semmelweis University|Zala Zala Megyei Szent Rafael Korhaz|Gujarat Dr. Jivraj Mehta Smarak Health Foundation|Maharashtra Grant Medical Foundation Ruby Hall Clinic|Rajasthan Eternal Hospital, Unit Of Eternal Heart Care Centre And Research Institute Pvt. Ltd.|Telangana Kumudini Devi Diabetes Research Center|Uttar Prandesh M.V Hospital And Research Centre|West Bengal Ipgme&R And Sskm Hospital|Soroka University Medical Center|Lombardy Humanitas Research Hospital|Milan Irccs Policlinico San Donato|Ospedale Cardinal Massaia|Sicily Azienda Ospedaliera Rilievo Nazionale Alta Specialita (Arnas) Garibaldi|Kraslavas Nov. Ogorelova Jelena Gp|Polana-D, Llc|Kedah Hospital Sultanah Bahiyah|Selangor University Malaya Medical Centre, Lembah Pantai|Guanajuato Centro De Investigacion Morales Vargas|Guillermina Hospital De La Paz|Jalisco Unidad De InvestigaciÃ³n ClÃ­nica En Medicina S.C.|YucatÃ¡n ClÃ­nica De MÃ©rida|Iloilo West Visayas State University Medical Center|Metro Manila St. Luke's Medical Center|Metropolitan Manila Manila Doctors Hospital, Ermita|Ncr Ospital Ng Makati|Kuj-Pom Vitamed Galaj I Cichomski Sp.J.|Lublin ZamoÅ›Ä‡|Malopolska Centermed Krakow Ltd|Masovian Oddzial Gastroenterologii Mazowieckie Centrum Rehabilitacji Stocer Sp. Z O.O.|Podlaski Diabet-Med|Podlaskie University Hospital BiaÅ‚ystok|Pomorskie Endoskopia Sp. Z O.O.|Powiatowe Centrum Medyczne W Wolowie Sp. Z O.O.|Specjalistyczny Gabinet Neurologiczny Marta Banach|Warmia-Mazury State Hospital|Oltenia Clintrial Medical Center, Pulmonology Department|Sana Medical Center|, Gauteng Wits Clinical Research|, Western Cape Endocare|Moriana Clinical Research|Hospital Universitario 12 De Octubre|Phramongkutklao Hospital|\"|Chernihiv City Hospital No 2 Of Chernihiv City Council|Dnipropetrovsk City Hospital 3|Odesa Region Odesa Regional Clinical Hospital|On The Base Of Pirogov National Medical University|Zaporizhzhia Region Municipal Institution City Hospital No. 7|, East Midland Queens Medical Centre|, Greater Manchester Mac Clinical Research Manchester|, Lancashire Royal Oldham Hospital|, London St George's Hospital|, Staffordshire Mac Research, Exchange House|, West Midlands Royal Wolverhampton Nhs Trust|, West Yorkshire Mac Clinical Research, Monarch House|Mac Research|North Alabama Research Center, Llc|Del Sol Research Management, Llc|Chi St. Vincent's Gastroenterology: John Tyler Baber, Md|Hope Clinical Research|Denver Esophageal And Stomach Center|Connecticut Clinical Research Foundation|Innovative Research Of West Fl, Inc.|Atlanta Diabetes Associates|Rocky Mountain Diabetes And Osteoporosis Center, Pa|Southwest Gastroenterology|Medisphere Medical Research Center, Llc|University Of Iowa Hospitals And Clinics|University Of Kansas Medical Center|University Of Louisville|The Center For Clinical Research|Metropolitan Gastroenterology Group Pc, Chevy Chase Clinical Research|Commonwealth Clinical Studies, Pllc.|Biocon Clinical Research, Llc|Washington University In St. Louis|Montana Medical Research|Diabetes And Endocrine Associates, P.C.|Clinical Research Of South Nevada - Crosn|Aga Clinical Research Associates Llc|Lovelace Scientific Resources, Inc.|Long Island Gastrointestinal Research Group Llp|Asheville Gastroenterology Associates|Dayton Gastroenterology,Inc.|Digestive Disease Specialists Inc|Northwest Gastroenterology Clinic, Llc|Family Medical Associates, Research Department|Partners In Clinical Research, Llc|Clinical Trials Of South Carolina|Health Concepts|Wr-Clinsearch, Llc|Texas Clinical Research Institute, Llc|Advanced Research Institute, Inc.|Blue Ridge Medical Research",{"$nulls":3},"Wieslaw (Wes) Bochenek, MD, PhD","2018-06-22","2020-05-25T16:40:18.276","2020-05-26T17:10:42.972","NCT03420781"]
["5ecbf4f2fe30261b1a04841f","NCT03420781","2018-08-07","Allergan","AGN","Enrolling by invitation","A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis Study 03","Relamorelin","GHS-R Agonist","Yes","['Relamorelin']","Yes","['GHS-R Agonist']","Phase 3",3,960,"Anticipated","2018-01-24","2020-12-06",{"$nulls":5},"A 46-week study to compare the efficacy of relamorelin with that of placebo in participants with diabetic gastroparesis (DG). At the end of the 40-week Treatment Period, participants will either continue on relamorelin or placebo for 6 additional weeks.",null,"A 46-week, Double-blind, Placebo-controlled, Phase 3 Study With a 6-week Randomized-withdrawal Period to Evaluate the Safety and Efficacy of Relamorelin in Patients With Diabetic Gastroparesis","RLM-MD-03","Gastroparesis\nDiabetes Mellitus","Paresis|Gastroparesis","Neurologic Manifestations|Gastrointestinal Diseases","Central Nervous System|Gastrointestinal","Experimental","Relamorelin 10 Î¼g|Relamorelin 10 Î¼g, followed by Placebo|Placebo, followed by Relamorelin 10 Î¼g","Relamorelin 10 Î¼g injected subcutaneously twice daily for 46 weeks.|Relamorelin 10 Î¼g injected subcutaneously twice daily for 40 weeks, followed by placebo injected twice daily for 6 weeks.|Placebo injected subcutaneously twice daily for 40 weeks, followed by Relamorelin 10 Î¼g injected twice daily for 6 weeks.","Drug","Relamorelin|Placebo","Relamorelin 10 Î¼g injected twice daily for 6, 40 or 46 weeks.|Placebo injected twice daily for 6 weeks or 40 weeks.",null,"Relamorelin 10 Î¼g|Relamorelin 10 Î¼g, followed by Placebo|Placebo, followed by Relamorelin 10 Î¼g","\n\n * Participants are eligible to be included in the study only if all the following criteria apply:\n * Participant met all inclusion/exclusion criteria of either Protocol RLM-MD-01 (NCT03285308) or Protocol RLM-MD-02 (NCT03426345) and successfully completed the study\n * Able to provide written informed consent (IC) prior to any study procedures and willing and able to comply with study procedures\n * In the opinion of the investigator, the participant demonstrated adequate compliance with the study procedures in Study RLM-MD-01 or RLM-MD-02\n\n","\n\n * Participants are excluded from the study if any of the following criteria apply:\n * Participant is not willing or able to abide by the restrictions regarding concomitant medicine use\n * Participant is planning to receive an investigational drug (other than study treatment) or investigational device at any time during Study RLM-MD-03\n * Participant has an unresolved adverse event (AE) or a clinically significant finding on physical examination, clinical laboratory test, or 12-lead electrocardiogram (ECG) that, in the investigator's opinion, would limit the participant's ability to participate in or complete the study\n * Any other reason that, in the investigator's opinion, would confound proper interpretation of the study or expose a participant to unacceptable risk, including renal, hepatic or cardiopulmonary disease",{"$nulls":4},"Actual","2018-02-05","Actual","Anticipated","2020-12-06","Anticipated","2018-08-01","2018-01-24","2018-02-01","2018-08-06","No","diabetic gastroparesis\nvomiting","Interventional","Treatment","Parallel Assignment","Triple (Participant, Care Provider, Investigator)","Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":19},"Diabetic Gastroparesis Symptom Severity Score (DGSSS) Week-12 Responder|Percentage of patients meeting the vomiting symptom responder criterion in each of the last 6 of the 12 weeks of treatment","Patients will assess severity of diabetic gastroparesis symptoms daily using an 11-point ordinal scale with 0 being least and 10 being the worst possible score. Patients will enter the score using an electronic diary.|Vomiting episodes will be patient-recorded daily using an electronic diary.","Baseline to Week 12","Nausea Week 12 Responder|Abdominal Pain Week 12 Responder|Bloating Week 12 Responder|Postprandial Fullness Week 12 Responder|DGSSS Week 40 Responder|DGSSS at Week 40|Vomiting Frequency at Week 40|Vomiting Week-40 Responder|DGSSS at Week 46|Number of Vomiting Episodes at Week 46|Number of Patients who experienced one or more Treatment Emergent Adverse Event (TEAE)","Nausea responder defined as a participant who has at least a 2-point improvement in the weekly symptom score at each of the last 6 weeks of the first 12 weeks of the 40-week Treatment Period. Nausea is assessed on an 11-point ordinal scale from 0 to 10, with 0 meaning no nausea, and 10 meaning the worst possible nausea.|Abdominal pain responder defined as a participant who has at least a 2-point improvement in the weekly symptom score at each of the last 6 weeks of the first 12 weeks of the 40-week Treatment Period. Abdominal Pain is assessed on an 11-point ordinal scale from 0 to 10, with 0 meaning no abdominal Pain, and 10 meaning the worst possible abdominal pain.|Bloating responder defined as a participant who has at least a 2-point improvement in the weekly symptom score at each of the last 6 weeks of the first 12 weeks of the 40-week Treatment Period. Bloating is assessed on an 11-point ordinal scale from 0 to 10, with 0 meaning no bloating, and 10 meaning the worst possible bloating.|Postprandial Fullness responder defined as a participant who has at least a 2-point improvement in the weekly symptom score at each of the last 6 weeks of the first 12 weeks of the 40-week Treatment Period.\n\nPostprandial Fullness is assessed on an 11-point ordinal scale from 0 to 10, with 0 meaning no feeling of fullness until finishing a meal, and 10 meaning felling full after only a few bites.|DGSSS responder defined as a participant who has at least a 10-point improvement in the DGSSS compared to baseline in each of the last 4 weeks of the 40-week Treatment Period.|Change from baseline to Week 40 in average weekly DGSSS. Average weekly scores are derived as the average of the weekly scores from the four weeks prior to Week 40 (Visit 7) in this study.|Change from baseline to Week 40 in average weekly number of vomiting episodes derived as the average of the weekly number of vomiting episodes during the four weeks prior to Week 40 (Visit 7) in this study.|Vomiting responder defined as a participant with zero weekly vomiting episodes during each of the last 4 weeks of the 40-week Treatment Period.|Change from baseline (CFB) to end of Randomized withdrawl period (RWP) in the average weekly DGSSS. Average weekly scores are derived as the average of the weekly scores from the six weeks of the RWP.|CFB to end of RWP in the average weekly number of vomiting episodes. Average weekly scores are derived as the average of the weekly number of vomiting episodes from the six weeks of the RWP.|The number of patients who experienced one or more TEAE during the 46 week treatment period.","Baseline to Week 12|Baseline to Week 40|Baseline to Week 46",{"$nulls":3},{"$cut":{"chars":22581,"head":"Buenos Aires, Ciudad AutÃ£Â³Noma De Buenos Aire, Argentina, C1425Agc|Caba, Argentina, C1180 Aax Centro Universitario De Investigacion En Farmacologia ClinicCorrientes, Argentina, W3410Avv|Kingswood, New South Wales, Australia, 2747|Woolloongabba, Queensland, Australia, 4102|Adelaide, South|Melbourne, Victoria, Australia, 3004 Royal Melbourne HospitalParkville, Victoria, Australia, 3050|Klagenfurt, Austria, 9020 Privatklinik Wehrle-DiakonissenSalzburg, Austria, 5020 OÃ£Æ’Ã¢Â¶. Gesundheits- Und Spitals-Ag/Lkh SteyrSteyr, Austria, 4400 Krankenanstalt Rudolfstiftung WienVienna, Austria, 1030 Kh HietzingVienna, Austria, 1130|Sankt Stefan Ob Stainz, Styria, Austria, 8511|Innsbruck, Tirol, Austria, A-6020|Feldkirch`, Vorarlberg, Austria, 6807|Edegem, Antwerp, Belgium, 2650|Jette, Brussel, Belgium, 1090|Brugge, West-Vlaanderen, Belgium, 8310|Fortaleza, CearÃ£Â¡, Brazil, 60160-230|Brasilia, Distrito Federal, Brazil, 71625175|Curitiba, ParanÃ£Â¡, Brazil, 80030-110|BelÃ£Â©M, ParÃ£Â¡, Brazil, 66073-000|Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000|FlorianÃ³polis, Santa Catarina, Brazil, 88015-230|Byala, Ruse, Bulgaria, 7100|Plovdiv, Bulgaria, 4002 Medical Center Asklepion - Humane Medicine Research EoodSofia, Bulgaria, 1303 Alexandrovska University HospitalSofia, Bulgaria, 1431|Calgary, Alberta, Canada, T2N 2T9 Alberta Diabetes InstituteEdmonton, Alberta, Canada, T6G 2E1 The Bailey ClinicRed Deer, Alberta, Canada, T4N 6V7|Vancouver, British Columbia, Canada, V5Z 1M9|St. John'S, Newfoundland And Labrador, Canada, A1B 3V6|Bridgewater, Nova Scotia, Canada, B4V 2V6|Ottawa, Ontario, Canada, K1H 7W9 Sunnybrook Health Science CentreToronto, Ontario, Canada, M4N 3M5 Toronto Western Hospital, University Health NetworkToronto, Ontario, Canada, M5T 2S8 Toronto Liver CentreToronto, Ontario, Canada, M6H 3M1 Dr. Anil K. Gupta Medicine Professional CorporationToronto, Ontario, Canada, M9V 4B4 Toronto Digestive Disease Associates, Inc.Vaughan, Ontario, Canada, L4L 4Y7|Greenfield Park, Quebec, Canada, J4V 2H1 Recherche Gcp ResearchMontreal, Quebec, Canada, H1M 1B1 Centre Hospitalier De L'Universite De Montreal - ChumMontreal, Quebec, Canada, H2X 0A9|Medellin, Antioquia, Colombia, 050034 Ips Rodrigo Botero SasMedellÃ£-N, Antioquia, Colombia, 50030 Rodrigo Botero S.A.S.MedellÃ­n, Antioquia, Colombia, 050030|BogotÃ¡, Cundinamarca, Colombia, 111111|BogotÃ¡, Distrito Capital De BogotÃ¡, Colombia, 110221 AsociaciÃ³n Colombiana De DiabetesTeusaquillo, Distrito Capital De BogotÃ¡, Colombia, 111311|Bogota, Distrito Capital De BogotÃ£Â¡, Colombia, 110221|Villavicencio, Meta, Colombia, 500001|Pereira, Risaralda, Colombia, 660002|Cali, Valle Del Cauca, Colombia, 760001 Centro Medico Imbanaco De Cali S.A.Cali, Valle Del Cauca, Colombia, 760042 Ips Centro Medico Julian Coronel S.ACali, Valle Del Cauca, Colombia, 76035 Ips Centro Medico Julian Coronel S.ASantiago De Cali, Valle Del Cauca, Colombia, 760035|Aalborg, Denmark, 9000 Mea KfaAarhus, Denmark, 8000|Hellerup, Copenhagen, Denmark, 2900 Gastroenheden, Hvidovre HospitalHvidovre, Copenhagen, Denmark, 2650|Corbeil Essonnes Cedex, France, 91106 GrenobleGrenoble, France, 38043 Hospices Civils De Lyon - HÃ£Â´Pital Edouard HerrriotLyon Cedex 03, France, 69437 Chu NantesNantes Cedex 1, France, 44093 Chu De PoitiersPoitiers, France, 86021 Hopital Charles NicolleRouen Cedex, France, 76031|Pessac, Gironde, France, 33604|VandÅ“uvre-LÃ¨s-Nancy, Grand Est, France, 54500|Colombes, ÃŽle-De-|Karlsruhe, Baden-WÃ£Â¼Rttemberg, Germany, 76137 Praxis Dr. Etzrodt-Walter Und KollegenUlm, Baden-WÃ£Â¼Rttemberg, Germany, 89073|Bad Berleburg, Germany, 57319 Clinical Research Unit/ UniversitÃ£Â¤Tsklinikum Giessen Und Marburg GmbhGiessen, Germany, 32392 Klinische Forschung Hamburg GmbhHamburg, Germany, 20253 Clinical Research HamburgHamburg, Germany, 22143 Israelitisches KrankenhausHamburg, Germany, 22297 Crh Clinic SiloahHannover, Germany, 30459|Schwerin, Mecklenburg Vorpommern, Germany, 19055|Hannover, Niedersachsen, Germany, 30159|BÃ¶hlen, Saxony, Germany, 4564 Klinische Forschung Dresden GmbhDresden, Saxony, Germany, 1309|Szeged,"}},"Alabama|Arizona|Arkansas|California|Colorado|Connecticut|Florida|Georgia|Idaho|Illinois|Indiana|Iowa|Kansas|Kentucky|Louisiana|Maryland|Massachusetts|Michigan|Montana|Nebraska|Nevada|New Jersey|New Mexico|New York|North Carolina|Ohio|Oklahoma|Oregon|Pennsylvania|Rhode Island|South Carolina|South Dakota|Tennessee|Texas|Utah|Virginia","Argentina|Australia|Austria|Belgium|Brazil|Bulgaria|Canada|Colombia|Denmark|France|Germany|Hungary|India|Israel|Italy|Latvia|Malaysia|Mexico|Philippines|Poland|Romania|South Africa|Spain|Thailand|Ukraine|United Kingdom|United States","Ciudad AutÃ£Â³Noma De Buenos Aire Consultorios Asociados De Endocrinologia E InvestigaciÃ£Â³N Cl|Sanatorio Guemes|New South Wales Nepean Hospital|Queensland Princess Alexandra Hospital|Royal Adelaide Hospital|Victoria The Alfred Hospital|Klinikum Klagenfurt Am WÃ£Â¶Rthersee|Styria Ordination|Tirol Medizinische Universitat Innsbruck|Vorarlberg Vivit Institute, Am Lkh Feldkirch|Antwerp Universitair Ziekenhuis Antwerpen, Gastro-Enterologie,|Brussel Uz Brussel|West-Vlaanderen Az Sint Lucas Brugge|CearÃ£Â¡ Instituto De Estudos E Pesquisas ClÃ£-Nicas Do CearÃ£Â¡ Ã‚â‚¬\" Iep/Ce - Oncology|Distrito Federal Centro De Pesquisa Clinica Do Brasil|ParanÃ£Â¡ Ceti - Centro De Estudos Em Terapias Inovadoras|ParÃ£Â¡ Hospital UniversitÃ£Â¡Rio JoÃ£Â£O De Barros Barreto - Ufpa|Rio Grande Do Sul Hospital SÃ£Â£O Lucas Da Puc-Rs|Santa Catarina Noova|Ruse Mhat Yuliya Vrevska Byala|Umhat - Kaspela- Eood|Alberta University Of Calgary|British Columbia Gordon And Leslie Diamond Health Care Centre|Newfoundland And Labrador Eastern Health|Nova Scotia South Shore Medical Arts|Ontario The Ottawa Hospital|Quebec Cisss De La Monteregie-Centre|Antioquia Centro Cardiovascular Colombiano ClÃ­nica Santa MarÃ­a|Cundinamarca Endocare Ltda.|Distrito Capital De BogotÃ¡ Medplus Mp|Distrito Capital De BogotÃ£Â¡ Medplus Medicina Prepagada|Meta Clinica Meta|Risaralda Fundacion Centro De Investigaciones Clinicas Cardiomet|Valle Del Cauca Centro Medico Imbanaco De Cali S.A.|Aalborg University Hospital|Copenhagen Gentofte Hospital|Corbeil Essonnes|Gironde Chu De Bordeaux - HÃ£Â´Pital Haut-LÃ£Â©VÃ£Âªque|Grand Est Chru Nancy|Hopital Louis Mourier, Service D'Hepato Gastro-Enterologie|Baden-WÃ£Â¼Rttemberg Klinische Forschung Karlsruhe Gmbh|Diabetologische Schwerpunktpraxis|Mecklenburg Vorpommern Klinische Forschung Schwerin Gmbh|Niedersachsen Klinische Forschung Hannover-Mitte Gmbh|Saxony Studienzentrum Schwittay|CsonfrÃ£Â¡D First Department Of Medicine, University Of Szeged|Heves Markhot Ferenc Oktatokorhaz Es Rendelointezet|JÃ¡sz-Nagykun-Szolnok Hetenyi Geza Hospital|Semmelweis University|Zala Zala Megyei Szent Rafael Korhaz|Gujarat Dr. Jivraj Mehta Smarak Health Foundation|Karnataka Lifecare Clinic And Research Centre|Maharashtra Grant Medical Foundation Ruby Hall Clinic|Rajasthan Sp Medical College|Telangana Kumudini Devi Diabetes Research Center|Uttar Prandesh M.V Hospital And Research Centre|West Bengal Ipgme&R And Sskm Hospital|Soroka University Medical Center|Lombardy Humanitas Research Hospital|Milan Irccs Policlinico San Donato|Ospedale Cardinal Massaia|Sicily Azienda Ospedaliera Rilievo Nazionale Alta Specialita (Arnas) Garibaldi|Kraslavas Nov. Ogorelova Jelena Gp|Polana-D, Llc|Kedah Hospital Sultanah Bahiyah|Selangor University Malaya Medical Centre, Lembah Pantai|Guanajuato Centro De Investigacion Morales Vargas|Guillermina Hospital De La Paz|Jalisco Unidad De InvestigaciÃ³n ClÃ­nica En Medicina S.C.|Nuevo LeÃ£Â³N Accelerium S. De R.L. De C.V.|Practice Dr Gerardo Gonzalez|Tlalpan Instituto Nacional De Ciencias MÃ£Â©Dicas Y NutriciÃ£Â³N Salvador ZubirÃ£Â¡N|YucatÃ¡n ClÃ­nica De MÃ©rida|Iloilo West Visayas State University Medical Center|Metro Manila St. Luke's Medical Center|Metropolitan Manila Manila Doctors Hospital, Ermita|Ncr Ospital Ng Makati|Perpetual Succor Hospital|Kuj-Pom Vitamed Galaj I Cichomski Sp.J.|Lublin ZamoÅ›Ä‡|Malopolska Centermed Krakow Ltd|Masovian Oddzial Gastroenterologii Mazowieckie Centrum Rehabilitacji Stocer Sp. Z O.O.|Podlaski Diabet-Med|Podlaskie University Hospital BiaÅ‚ystok|Pomorskie Endoskopia Sp. Z O.O.|Powiatowe Centrum Medyczne W Wolowie Sp. Z O.O.|Specjalistyczny Gabinet Neurologiczny Marta Banach|Warmia-Mazury State Hospital|Oltenia Clintrial Medical Center, Pulmonology Department|Sana Medical Center|, Free State Farmovs|, Gauteng Wits Clinical Research|, Western Cape Endocare|Moriana Clinical Research|Hospital Clinico Universitario San Carlos|Phramongkutklao Hospital|\"|Chernihiv City Hospital No 2 Of Chernihiv City Council|Dnipropetrovsk City Hospital 3|Odesa Region Odesa Regional Clinical Hospital|On The Base Of Pirogov National Medical University|Zaporizhzhia Region Municipal Institution City Hospital No. 7|, East Midland Queens Medical Centre|, Greater Manchester Mac Clinical Research Manchester|, Lancashire Royal Oldham Hospital|, London St George's Hospital|, Staffordshire Mac Research, Exchange House|, West Midlands Royal Wolverhampton Nhs Trust|, West Yorkshire Mac Clinical Research, Monarch House|Mac Research|North Alabama Research Center, Llc|Del Sol Research Management, Llc|Chi St. Vincent's Gastroenterology: John Tyler Baber, Md|Hope Clinical Research|Denver Esophageal And Stomach Center|Connecticut Clinical Research Foundation|Innovative Research Of West Fl, Inc.|Atlanta Diabetes Associates|Rocky Mountain Diabetes And Osteoporosis Center, Pa|North Shore University Health System|Medisphere Medical Research Center, Llc|University Of Iowa Hospitals And Clinics|University Of Kansas Medical Center|Tri-State Gastroenterology|The Center For Clinical Research|Metropolitan Gastroenterology Group Pc, Chevy Chase Clinical Research|Commonwealth Clinical Studies, Pllc.|Clinical Research Institute Of Michigan|Montana Medical Research|Diabetes And Endocrine Associates, P.C.|Clinical Research Of South Nevada - Crosn|Aga Clinical Research Associates Llc|Lovelace Scientific Resources, Inc.|Long Island Gastrointestinal Research Group Llp|Asheville Gastroenterology Associates|Dayton Gastroenterology,Inc.|Digestive Disease Specialists Inc|Northwest Gastroenterology Clinic, Llc|Family Medical Associates, Research Department|Partners In Clinical Research, Llc|Clinical Trials Of South Carolina|Health Concepts|Wr-Clinsearch, Llc|Texas Clinical Research Institute, Llc|Advanced Research Institute, Inc.|Blue Ridge Medical Research",{"$nulls":3},"Wieslaw (Wes) Bochenek, MD, PhD","2018-08-06","2020-05-25T16:40:18.801","2020-05-26T17:10:42.972","NCT03420781"]
["5ecbf4f211702c1b1b916c2c","NCT03420781","2018-11-23","Allergan","AGN","Enrolling by invitation","A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis Study 03","Relamorelin","GHS-R Agonist","Yes","['Relamorelin']","Yes","['GHS-R Agonist']","Phase 3",3,960,"Anticipated","2018-01-24","2020-12-06",{"$nulls":5},"A 46-week study to compare the efficacy of relamorelin with that of placebo in participants with diabetic gastroparesis (DG). At the end of the 40-week Treatment Period, participants will either continue on relamorelin or placebo for 6 additional weeks.",null,"A 46-week, Double-blind, Placebo-controlled, Phase 3 Study With a 6-week Randomized-withdrawal Period to Evaluate the Safety and Efficacy of Relamorelin in Patients With Diabetic Gastroparesis","RLM-MD-03","Gastroparesis\nDiabetes Mellitus","Paresis|Gastroparesis","Neurologic Manifestations|Gastrointestinal Diseases","Central Nervous System|Gastrointestinal","Experimental","Relamorelin 10 Î¼g|Relamorelin 10 Î¼g, followed by Placebo|Placebo, followed by Relamorelin 10 Î¼g","Relamorelin 10 Î¼g injected subcutaneously twice daily for 46 weeks.|Relamorelin 10 Î¼g injected subcutaneously twice daily for 40 weeks, followed by placebo injected twice daily for 6 weeks.|Placebo injected subcutaneously twice daily for 40 weeks, followed by Relamorelin 10 Î¼g injected twice daily for 6 weeks.","Drug","Relamorelin|Placebo","Relamorelin 10 Î¼g injected twice daily for 6, 40 or 46 weeks.|Placebo injected twice daily for 6 weeks or 40 weeks.",null,"Relamorelin 10 Î¼g|Relamorelin 10 Î¼g, followed by Placebo|Placebo, followed by Relamorelin 10 Î¼g","\n\n * Participants are eligible to be included in the study only if all the following criteria apply:\n * Participant met all inclusion/exclusion criteria of either Protocol RLM-MD-01 (NCT03285308) or Protocol RLM-MD-02 (NCT03426345) and successfully completed the study\n * Able to provide written informed consent (IC) prior to any study procedures and willing and able to comply with study procedures\n * In the opinion of the investigator, the participant demonstrated adequate compliance with the study procedures in Study RLM-MD-01 or RLM-MD-02\n\n","\n\n * Participants are excluded from the study if any of the following criteria apply:\n * Participant is not willing or able to abide by the restrictions regarding concomitant medicine use\n * Participant is planning to receive an investigational drug (other than study treatment) or investigational device at any time during Study RLM-MD-03\n * Participant has an unresolved adverse event (AE) or a clinically significant finding on physical examination, clinical laboratory test, or 12-lead electrocardiogram (ECG) that, in the investigator's opinion, would limit the participant's ability to participate in or complete the study\n * Any other reason that, in the investigator's opinion, would confound proper interpretation of the study or expose a participant to unacceptable risk, including renal, hepatic or cardiopulmonary disease",{"$nulls":4},"Actual","2018-02-05","Actual","Anticipated","2020-12-06","Anticipated","2018-11-01","2018-01-24","2018-02-01","2018-11-20","No","diabetic gastroparesis\nvomiting","Interventional","Treatment","Parallel Assignment","Triple (Participant, Care Provider, Investigator)","Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":19},"Diabetic Gastroparesis Symptom Severity Score (DGSSS) Week-12 Responder|Percentage of patients meeting the vomiting symptom responder criterion in each of the last 6 of the 12 weeks of treatment","Patients will assess severity of diabetic gastroparesis symptoms daily using an 11-point ordinal scale with 0 being least and 10 being the worst possible score. Patients will enter the score using an electronic diary.|Vomiting episodes will be patient-recorded daily using an electronic diary.","Baseline to Week 12","Nausea Week 12 Responder|Abdominal Pain Week 12 Responder|Bloating Week 12 Responder|Postprandial Fullness Week 12 Responder|DGSSS Week 40 Responder|DGSSS at Week 40|Vomiting Frequency at Week 40|Vomiting Week-40 Responder|DGSSS at Week 46|Number of Vomiting Episodes at Week 46|Number of Patients who experienced one or more Treatment Emergent Adverse Event (TEAE)","Nausea responder defined as a participant who has at least a 2-point improvement in the weekly symptom score at each of the last 6 weeks of the first 12 weeks of the 40-week Treatment Period. Nausea is assessed on an 11-point ordinal scale from 0 to 10, with 0 meaning no nausea, and 10 meaning the worst possible nausea.|Abdominal pain responder defined as a participant who has at least a 2-point improvement in the weekly symptom score at each of the last 6 weeks of the first 12 weeks of the 40-week Treatment Period. Abdominal Pain is assessed on an 11-point ordinal scale from 0 to 10, with 0 meaning no abdominal Pain, and 10 meaning the worst possible abdominal pain.|Bloating responder defined as a participant who has at least a 2-point improvement in the weekly symptom score at each of the last 6 weeks of the first 12 weeks of the 40-week Treatment Period. Bloating is assessed on an 11-point ordinal scale from 0 to 10, with 0 meaning no bloating, and 10 meaning the worst possible bloating.|Postprandial Fullness responder defined as a participant who has at least a 2-point improvement in the weekly symptom score at each of the last 6 weeks of the first 12 weeks of the 40-week Treatment Period.\n\nPostprandial Fullness is assessed on an 11-point ordinal scale from 0 to 10, with 0 meaning no feeling of fullness until finishing a meal, and 10 meaning felling full after only a few bites.|DGSSS responder defined as a participant who has at least a 10-point improvement in the DGSSS compared to baseline in each of the last 4 weeks of the 40-week Treatment Period.|Change from baseline to Week 40 in average weekly DGSSS. Average weekly scores are derived as the average of the weekly scores from the four weeks prior to Week 40 (Visit 7) in this study.|Change from baseline to Week 40 in average weekly number of vomiting episodes derived as the average of the weekly number of vomiting episodes during the four weeks prior to Week 40 (Visit 7) in this study.|Vomiting responder defined as a participant with zero weekly vomiting episodes during each of the last 4 weeks of the 40-week Treatment Period.|Change from baseline (CFB) to end of Randomized withdrawl period (RWP) in the average weekly DGSSS. Average weekly scores are derived as the average of the weekly scores from the six weeks of the RWP.|CFB to end of RWP in the average weekly number of vomiting episodes. Average weekly scores are derived as the average of the weekly number of vomiting episodes from the six weeks of the RWP.|The number of patients who experienced one or more TEAE during the 46 week treatment period.","Baseline to Week 12|Baseline to Week 40|Baseline to Week 46",{"$nulls":3},{"$cut":{"chars":24543,"head":"Moron, Buenos Aires, Argentina, 1708|Buenos Aires, Ciudad Autonoma De Buenos Aires, Argentina, C1425Agc|Caba, Argentina, C1180 Aax CiprecCiudad Autonoma De Buenos Aires, Argentina, 1119 Centro Universitario De Investigacion En Farmacologia ClinicCorrientes, Argentina, W3410Avv|Rosario, Santa Fe, Argentina, 2000 Instituto De Hematologia Y Medicina Clinica Dr. Ruben DavoliRosario, Santa Fe, Argentina, S200Cfk|Kingswood, New South Wales, Australia, 2747|Woolloongabba, Queensland, Australia, 4102|Adelaide, South|Melbourne, Victoria, Australia, 3004 Royal Melbourne HospitalParkville, Victoria, Australia, 3050|Klagenfurt, Austria, 9020 Privatklinik Wehrle-DiakonissenSalzburg, Austria, 5020 Gesundheits- Und Spitals-Ag/Lkh SteyrSteyr, Austria, 4400|Sankt Stefan Ob Stainz, Styria, Austria, 8511|Innsbruck, Tirol, Austria, A-6020|Feldkirch`, Vorarlberg, Austria, 6807|Edegem, Antwerp, Belgium, 2650|Jette, Brussel, Belgium, 1090|Brussels, Belgium, 1070|Brugge, West-Vlaanderen, Belgium, 8310|Fortaleza, Ceara, Brazil, 60160-230 Hospital Universitario Walter CantadioFortaleza, Ceara, Brazil, 60430270|Sao Paulo, Brazil, 01228-000 Universidade De Sao Paulo (Usp) - Hospital Das Clinicas Da FSao Paulo, Brazil, 5403000|Brasilia, Distrito Federal, Brazil, 71625175|BelÃ©m, Para, Brazil, 66073-000|Curitiba, Parana, Brazil, 80030-110|BelÃ£Â©M, ParÃ£Â¡, Brazil, 66073-000|Passo Fundo, Rio Grande Do Sul, Brazil, 99010-080 Hospital De Clinicas De Porto AlegrePorto Alegre, Rio Grande Do Sul, Brazil, 90035-003 Hospital Sao Lucas Da Puc-RsPorto Alegre, Rio Grande Do Sul, Brazil, 90610-000|FlorianÃ³polis, Santa Catarina, Brazil, 88015-230 Instituto Catarinense De Endocrinologia E Diabetes (Iced)Joinville, Santa Catarina, Brazil, 89201-260|Campinas, Sao Paulo, Brazil, 13060904|Byala, Ruse, Bulgaria, 7100|Plovdiv, Bulgaria, 4002 Medical Center Asklepion - Humane Medicine Research EoodSofia, Bulgaria, 1303 Alexandrovska University HospitalSofia, Bulgaria, 1431|Calgary, Alberta, Canada, T2N 2T9 Alberta Diabetes InstituteEdmonton, Alberta, Canada, T6G 2E1 The Bailey ClinicRed Deer, Alberta, Canada, T4N 6V7|Vancouver, British Columbia, Canada, V5Z 1M9|St. John'S, Newfoundland And Labrador, Canada, A1B 3V6|Bridgewater, Nova Scotia, Canada, B4V 2V6|Ottawa, Ontario, Canada, K1H 7W9 Sunnybrook Health Science CentreToronto, Ontario, Canada, M4N 3M5 Toronto Western Hospital, University Health NetworkToronto, Ontario, Canada, M5T 2S8 Toronto Liver CentreToronto, Ontario, Canada, M6H 3M1 Toronto Digestive Disease Associates, Inc.Vaughan, Ontario, Canada, L4L 4Y7|Greenfield Park, Quebec, Canada, J4V 2H1 Recherche Gcp ResearchMontreal, Quebec, Canada, H1M 1B1 Centre Hospitalier De L'Universite De Montreal - ChumMontreal, Quebec, Canada, H2X 0A9|Medellin, Antioquia, Colombia, 050034 Ips Rodrigo Botero SasMedellÃ­n, Antioquia, Colombia, 050030|Barranquilla, Atlantico, Colombia, 080020 Fundacion BiosBarranquilla, Atlantico, Colombia, 080020|BogotÃ¡, Cundinamarca, Colombia, 111111 Healthy Medical CenterZipaquira, Cundinamarca, Colombia, 250252|Bogota, Distrito Capital De Bogota, Colombia, 110221|Teusaquillo, Distrito Capital De BogotÃ¡, Colombia, 111311|Villavicencio, Meta, Colombia, 500001|Pereira, Risaralda, Colombia, 660002|Cali, Valle Del Cauca, Colombia, 760001 Ips Centro Medico Julian Coronel S.ACali, Valle Del Cauca, Colombia, 760035|Aalborg, Denmark, 9000|Hellerup, Copenhagen, Denmark, 2900 Gastroenheden, Hvidovre HospitalHvidovre, Copenhagen, Denmark, 2650|Corbeil Essonnes Cedex, France, 91106 GrenobleGrenoble, France, 38043 Hospices Civils De Lyon - HÃ£Â´Pital Edouard HerrriotLyon Cedex 03, France, 69437 Chu NantesNantes Cedex 1, France, 44093 Chu De PoitiersPoitiers, France, 86021 Hopital Charles NicolleRouen Cedex, France, 76031|Pessac, Gironde, France, 33604|VandÅ“uvre-LÃ¨s-Nancy, Grand Est, France, 54500|Colombes, ÃŽle-De-|Karlsruhe, Baden-WÃ£Â¼Rttemberg, Germany, 76137 Praxis Dr. Etzrodt-Walter Und KollegenUlm, Baden-WÃ£Â¼Rttemberg, Germany, 89073|Bad Berleburg, Germany, 57319 Clinical Research Unit/ UniversitÃ£Â¤Tsklinikum Giessen Und Marburg GmbhGiessen, G"}},"Alabama|Arizona|Arkansas|California|Colorado|Connecticut|Florida|Georgia|Idaho|Illinois|Indiana|Iowa|Kansas|Kentucky|Louisiana|Maryland|Massachusetts|Michigan|Montana|Nebraska|Nevada|New Jersey|New Mexico|New York|North Carolina|Ohio|Oklahoma|Oregon|Pennsylvania|Rhode Island|South Carolina|South Dakota|Tennessee|Texas|Utah|Virginia|West Virginia","Argentina|Australia|Austria|Belgium|Brazil|Bulgaria|Canada|Colombia|Denmark|France|Germany|Hungary|India|Israel|Italy|Latvia|Malaysia|Mexico|Philippines|Poland|Romania|South Africa|Spain|Thailand|Ukraine|United Kingdom|United States","Buenos Aires Ciad Moron|Ciudad Autonoma De Buenos Aires Consultorios Asociados De Endocrinologia E Investigacion Cl|Sanatorio Guemes|Santa Fe Instituto De Investigaciones Clinicas De Rosario|New South Wales Nepean Hospital|Queensland Princess Alexandra Hospital|Royal Adelaide Hospital|Victoria The Alfred Hospital|Klinikum Klagenfurt Am WÃ£Â¶Rthersee|Styria Ordination|Tirol Medizinische Universitat Innsbruck|Vorarlberg Vivit Institute, Am Lkh Feldkirch|Antwerp Universitair Ziekenhuis Antwerpen, Gastro-Enterologie,|Brussel Uz Brussel|Hopitaux Iris Sud - Joseph Bracops|West-Vlaanderen Az Sint Lucas Brugge|Ceara Instituto De Estudos E Pesquisas Clinicas Do Ceara Iep/Ce - Oncology|Cpquali Pesquisa Clinica Ltda|Distrito Federal Centro De Pesquisa Clinica Do Brasil|Para Hospital Universitario Joao De Barros Barreto - Ufpa|Parana Ceti - Centro De Estudos Em Terapias Inovadoras|ParÃ£Â¡ Hospital UniversitÃ£Â¡Rio JoÃ£Â£O De Barros Barreto - Ufpa|Rio Grande Do Sul Hospital Sao Vicente De Paulo|Santa Catarina Noova|Sao Paulo Instituto De Pesquisa Clinica De Campinas|Ruse Mhat Yuliya Vrevska Byala|Umhat - Kaspela- Eood|Alberta University Of Calgary|British Columbia Gordon And Leslie Diamond Health Care Centre|Newfoundland And Labrador Eastern Health|Nova Scotia South Shore Medical Arts|Ontario The Ottawa Hospital|Quebec Cisss De La Monteregie-Centre|Antioquia Centro Cardiovascular Colombiano ClÃ­nica Santa MarÃ­a|Atlantico Centro Cardiovascular Y De Diabetes|Cundinamarca Endocare Ltda.|Distrito Capital De Bogota Medplus Medicina Prepagada|Distrito Capital De BogotÃ¡ AsociaciÃ³n Colombiana De Diabetes|Meta Clinica Meta|Risaralda Fundacion Centro De Investigaciones Clinicas Cardiomet|Valle Del Cauca Centro Medico Imbanaco De Cali S.A.|Aalborg University Hospital|Copenhagen Gentofte Hospital|Corbeil Essonnes|Gironde Chu De Bordeaux - HÃ£Â´Pital Haut-LÃ£Â©VÃ£Âªque|Grand Est Chru Nancy|Hopital Louis Mourier, Service D'Hepato Gastro-Enterologie|Baden-WÃ£Â¼Rttemberg Klinische Forschung Karlsruhe Gmbh|Diabetologische Schwerpunktpraxis|Mecklenburg Vorpommern Klinische Forschung Schwerin Gmbh|Niedersachsen Klinische Forschung Hannover-Mitte Gmbh|Saxony Studienzentrum Schwittay|CsonfrÃ£Â¡D First Department Of Medicine, University Of Szeged|Heves Markhot Ferenc Oktatokorhaz Es Rendelointezet|JÃ¡sz-Nagykun-Szolnok Hetenyi Geza Hospital|Semmelweis University|Zala Zala Megyei Szent Rafael Korhaz|Andhra Pradesh King George Hospital|Gujarat Dr. Jivraj Mehta Smarak Health Foundation|Karnataka Lifecare Clinic And Research Centre|Maharashtra Bhatia Hospital|Rajasthan Sp Medical College|Sir Ganga Ram Hospital (Sgrh)|Tamil Nadu Kovai Diabetes Speciality Centre|Telangana Kumudini Devi Diabetes Research Center|Uttar Prandesh M.V Hospital And Research Centre|West Bengal Ipgme&R And Sskm Hospital|Soroka University Medical Center|Lombardy Humanitas Research Hospital|Milan Irccs Policlinico San Donato|Ospedale Cardinal Massaia|Sicily Azienda Ospedaliera Rilievo Nazionale Alta Specialita (Arnas) Garibaldi|Kraslavas Nov. Ogorelova Jelena Gp|Polana-D, Llc|Kedah Hospital Sultanah Bahiyah|Selangor University Malaya Medical Centre, Lembah Pantai|Guanajuato Morales Vargas Centro De Investigacion Sc|Guillermina Hospital De La Paz|Hidalgo Resultados Medicos Desarrollo E Investigacion S.C|Jalisco Consultorio Medico|Morelos Not Yet Instituto De Diabetes Obesidad Y Nutricion Sc|Nuevo Leon Accelerium S. De R.L. De C.V.|Practice Dr Gerardo Gonzalez|Tlalpan Instituto Nacional De Ciencias Medicas Y Nutricion Salvador Zubiran|Veracruz Centro Especializado En Investigacion Clinica S.C.|YucatÃ¡n ClÃ­nica De MÃ©rida|Iloilo West Visayas State University Medical Center|Metro Manila St. Luke's Medical Center|Metropolitan Manila Manila Doctors Hospital, Ermita|Ncr Ospital Ng Makati|Perpetual Succor Hospital|Kuj-Pom Vitamed Galaj I Cichomski Sp.J.|Lublin ZamoÅ›Ä‡|Malopolska Centermed Krakow Ltd|Masovian Oddzial Gastroenterologii Mazowieckie Centrum Rehabilitacji Stocer Sp. Z O.O.|Podlaski Diabet-Med|Podlaskie University Hospital BiaÅ‚ystok|Pomorskie Endoskopia Sp. Z O.O.|Powiatowe Centrum Medyczne W Wolowie Sp. Z O.O.|Specjalistyczny Gabinet Neurologiczny Marta Banach|Warmia-Mazury State Hospital|Oltenia Clintrial Medical Center, Pulmonology Department|Sana Medical Center|, Free State Farmovs|, Gauteng Wits Clinical Research|Synexus Helderberg Clinical Research Centre|Hospital Clinico Universitario San Carlos|Phramongkutklao Hospital|\"|Chernihiv City Hospital No 2 Of Chernihiv City Council|Dnipropetrovsk City Hospital 3|Odesa Region Odesa Regional Clinical Hospital|On The Base Of Pirogov National Medical University|Zaporizhzhia Region Municipal Institution City Hospital No. 7|, East Midland Queens Medical Centre|, Greater Manchester Mac Clinical Research Manchester|, Lancashire Royal Oldham Hospital|, Staffordshire Mac Research, Exchange House|, West Midlands Royal Wolverhampton Nhs Trust|, West Yorkshire Mac Clinical Research, Monarch House|Mac Research|North Alabama Research Center, Llc|Del Sol Research Management, Llc|Chi St. Vincent's Gastroenterology: John Tyler Baber, Md|Hcp Clinical Research Llc|Peak Gastroenterology Associates|Gastroenterology Associates Of Fairfield County, P.C.|Innovative Research Of West Fl, Inc.|Atlanta Diabetes Associates|Rocky Mountain Diabetes And Osteoporosis Center, Pa|North Shore University Health System|Medisphere Medical Research Center, Llc|University Of Iowa Hospitals And Clinics|University Of Kansas Medical Center|Tri-State Gastroenterology|The Center For Clinical Research|Metropolitan Gastroenterology Group Pc, Chevy Chase Clinical Research|Commonwealth Clinical Studies, Pllc.|Clinical Research Institute Of Michigan|Montana Medical Research|Diabetes And Endocrine Associates, P.C.|Clinical Research Of South Nevada - Crosn|Aga Clinical Research Associates Llc|Lovelace Scientific Resources, Inc.|Long Island Gastrointestinal Research Group Llp|Asheville Gastroenterology Associates|Dayton Gastroenterology,Inc.|Digestive Disease Specialists Inc|Northwest Gastroenterology Clinic, Llc|Family Medical Associates, Research Department|Partners In Clinical Research, Llc|Clinical Trials Of South Carolina|Health Concepts|Wr-Clinsearch, Llc|Texas Clinical Research Institute, Llc|Advanced Research Institute, Inc.|Blue Ridge Medical Research|West Virginia University",{"$nulls":3},"Wieslaw (Wes) Bochenek, MD, PhD","2018-11-20","2020-05-25T16:40:18.918","2020-05-26T17:10:42.972","NCT03420781"]
["5ecbf4f2307e3d1b1f8d9eb1","NCT03420781","2018-12-12","Allergan","AGN","Enrolling by invitation","A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis Study 03","Relamorelin","GHS-R Agonist","Yes","['Relamorelin']","Yes","['GHS-R Agonist']","Phase 3",3,960,"Anticipated","2018-01-24","2020-12-06",{"$nulls":5},"A 46-week study to compare the efficacy of relamorelin with that of placebo in participants with diabetic gastroparesis (DG). At the end of the 40-week Treatment Period, participants will either continue on relamorelin or placebo for 6 additional weeks.",null,"A 46-week, Double-blind, Placebo-controlled, Phase 3 Study With a 6-week Randomized-withdrawal Period to Evaluate the Safety and Efficacy of Relamorelin in Patients With Diabetic Gastroparesis","RLM-MD-03","Gastroparesis\nDiabetes Mellitus","Paresis|Gastroparesis","Neurologic Manifestations|Gastrointestinal Diseases","Central Nervous System|Gastrointestinal","Experimental","Relamorelin 10 Î¼g|Relamorelin 10 Î¼g, followed by Placebo|Placebo, followed by Relamorelin 10 Î¼g","Relamorelin 10 Î¼g injected subcutaneously twice daily for 46 weeks.|Relamorelin 10 Î¼g injected subcutaneously twice daily for 40 weeks, followed by placebo injected twice daily for 6 weeks.|Placebo injected subcutaneously twice daily for 40 weeks, followed by Relamorelin 10 Î¼g injected twice daily for 6 weeks.","Drug","Relamorelin|Placebo","Relamorelin 10 Î¼g injected twice daily for 6, 40 or 46 weeks.|Placebo injected twice daily for 6 weeks or 40 weeks.",null,"Relamorelin 10 Î¼g|Relamorelin 10 Î¼g, followed by Placebo|Placebo, followed by Relamorelin 10 Î¼g","\n\n * Participants are eligible to be included in the study only if all the following criteria apply:\n * Participant met all inclusion/exclusion criteria of either Protocol RLM-MD-01 (NCT03285308) or Protocol RLM-MD-02 (NCT03426345) and successfully completed the study\n * Able to provide written informed consent (IC) prior to any study procedures and willing and able to comply with study procedures\n * In the opinion of the investigator, the participant demonstrated adequate compliance with the study procedures in Study RLM-MD-01 or RLM-MD-02\n\n","\n\n * Participants are excluded from the study if any of the following criteria apply:\n * Participant is not willing or able to abide by the restrictions regarding concomitant medicine use\n * Participant is planning to receive an investigational drug (other than study treatment) or investigational device at any time during Study RLM-MD-03\n * Participant has an unresolved adverse event (AE) or a clinically significant finding on physical examination, clinical laboratory test, or 12-lead electrocardiogram (ECG) that, in the investigator's opinion, would limit the participant's ability to participate in or complete the study\n * Any other reason that, in the investigator's opinion, would confound proper interpretation of the study or expose a participant to unacceptable risk, including renal, hepatic or cardiopulmonary disease",{"$nulls":4},"Actual","2018-02-05","Actual","Anticipated","2020-12-06","Anticipated","2018-12-01","2018-01-24","2018-02-01","2018-12-10","No","diabetic gastroparesis\nvomiting","Interventional","Treatment","Parallel Assignment","Triple (Participant, Care Provider, Investigator)","Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":19},"Diabetic Gastroparesis Symptom Severity Score (DGSSS) Week-12 Responder|Percentage of patients meeting the vomiting symptom responder criterion in each of the last 6 of the 12 weeks of treatment","Patients will assess severity of diabetic gastroparesis symptoms daily using an 11-point ordinal scale with 0 being least and 10 being the worst possible score. Patients will enter the score using an electronic diary.|Vomiting episodes will be patient-recorded daily using an electronic diary.","Baseline to Week 12","Nausea Week 12 Responder|Abdominal Pain Week 12 Responder|Bloating Week 12 Responder|Postprandial Fullness Week 12 Responder|DGSSS Week 40 Responder|DGSSS at Week 40|Vomiting Frequency at Week 40|Vomiting Week-40 Responder|DGSSS at Week 46|Number of Vomiting Episodes at Week 46|Number of Patients who experienced one or more Treatment Emergent Adverse Event (TEAE)","Nausea responder defined as a participant who has at least a 2-point improvement in the weekly symptom score at each of the last 6 weeks of the first 12 weeks of the 40-week Treatment Period. Nausea is assessed on an 11-point ordinal scale from 0 to 10, with 0 meaning no nausea, and 10 meaning the worst possible nausea.|Abdominal pain responder defined as a participant who has at least a 2-point improvement in the weekly symptom score at each of the last 6 weeks of the first 12 weeks of the 40-week Treatment Period. Abdominal Pain is assessed on an 11-point ordinal scale from 0 to 10, with 0 meaning no abdominal Pain, and 10 meaning the worst possible abdominal pain.|Bloating responder defined as a participant who has at least a 2-point improvement in the weekly symptom score at each of the last 6 weeks of the first 12 weeks of the 40-week Treatment Period. Bloating is assessed on an 11-point ordinal scale from 0 to 10, with 0 meaning no bloating, and 10 meaning the worst possible bloating.|Postprandial Fullness responder defined as a participant who has at least a 2-point improvement in the weekly symptom score at each of the last 6 weeks of the first 12 weeks of the 40-week Treatment Period.\n\nPostprandial Fullness is assessed on an 11-point ordinal scale from 0 to 10, with 0 meaning no feeling of fullness until finishing a meal, and 10 meaning felling full after only a few bites.|DGSSS responder defined as a participant who has at least a 10-point improvement in the DGSSS compared to baseline in each of the last 4 weeks of the 40-week Treatment Period.|Change from baseline to Week 40 in average weekly DGSSS. Average weekly scores are derived as the average of the weekly scores from the four weeks prior to Week 40 (Visit 7) in this study.|Change from baseline to Week 40 in average weekly number of vomiting episodes derived as the average of the weekly number of vomiting episodes during the four weeks prior to Week 40 (Visit 7) in this study.|Vomiting responder defined as a participant with zero weekly vomiting episodes during each of the last 4 weeks of the 40-week Treatment Period.|Change from baseline (CFB) to end of Randomized withdrawl period (RWP) in the average weekly DGSSS. Average weekly scores are derived as the average of the weekly scores from the six weeks of the RWP.|CFB to end of RWP in the average weekly number of vomiting episodes. Average weekly scores are derived as the average of the weekly number of vomiting episodes from the six weeks of the RWP.|The number of patients who experienced one or more TEAE during the 46 week treatment period.","Baseline to Week 12|Baseline to Week 40|Baseline to Week 46",{"$nulls":3},{"$cut":{"chars":24543,"head":"Moron, Buenos Aires, Argentina, 1708|Buenos Aires, Ciudad Autonoma De Buenos Aires, Argentina, C1425Agc|Caba, Argentina, C1180 Aax CiprecCiudad Autonoma De Buenos Aires, Argentina, 1119 Centro Universitario De Investigacion En Farmacologia ClinicCorrientes, Argentina, W3410Avv|Rosario, Santa Fe, Argentina, 2000 Instituto De Hematologia Y Medicina Clinica Dr. Ruben DavoliRosario, Santa Fe, Argentina, S200Cfk|Kingswood, New South Wales, Australia, 2747|Woolloongabba, Queensland, Australia, 4102|Adelaide, South|Melbourne, Victoria, Australia, 3004 Royal Melbourne HospitalParkville, Victoria, Australia, 3050|Klagenfurt, Austria, 9020 Privatklinik Wehrle-DiakonissenSalzburg, Austria, 5020 Gesundheits- Und Spitals-Ag/Lkh SteyrSteyr, Austria, 4400|Sankt Stefan Ob Stainz, Styria, Austria, 8511|Innsbruck, Tirol, Austria, A-6020|Feldkirch`, Vorarlberg, Austria, 6807|Edegem, Antwerp, Belgium, 2650|Jette, Brussel, Belgium, 1090|Brussels, Belgium, 1070|Brugge, West-Vlaanderen, Belgium, 8310|Fortaleza, Ceara, Brazil, 60160-230 Hospital Universitario Walter CantadioFortaleza, Ceara, Brazil, 60430270|Sao Paulo, Brazil, 01228-000 Universidade De Sao Paulo (Usp) - Hospital Das Clinicas Da FSao Paulo, Brazil, 5403000|Brasilia, Distrito Federal, Brazil, 71625175|BelÃ©m, Para, Brazil, 66073-000|Curitiba, Parana, Brazil, 80030-110|BelÃ£Â©M, ParÃ£Â¡, Brazil, 66073-000|Passo Fundo, Rio Grande Do Sul, Brazil, 99010-080 Hospital De Clinicas De Porto AlegrePorto Alegre, Rio Grande Do Sul, Brazil, 90035-003 Hospital Sao Lucas Da Puc-RsPorto Alegre, Rio Grande Do Sul, Brazil, 90610-000|FlorianÃ³polis, Santa Catarina, Brazil, 88015-230 Instituto Catarinense De Endocrinologia E Diabetes (Iced)Joinville, Santa Catarina, Brazil, 89201-260|Campinas, Sao Paulo, Brazil, 13060904|Byala, Ruse, Bulgaria, 7100|Plovdiv, Bulgaria, 4002 Medical Center Asklepion - Humane Medicine Research EoodSofia, Bulgaria, 1303 Alexandrovska University HospitalSofia, Bulgaria, 1431|Calgary, Alberta, Canada, T2N 2T9 Alberta Diabetes InstituteEdmonton, Alberta, Canada, T6G 2E1 The Bailey ClinicRed Deer, Alberta, Canada, T4N 6V7|Vancouver, British Columbia, Canada, V5Z 1M9|St. John'S, Newfoundland And Labrador, Canada, A1B 3V6|Bridgewater, Nova Scotia, Canada, B4V 2V6|Ottawa, Ontario, Canada, K1H 7W9 Sunnybrook Health Science CentreToronto, Ontario, Canada, M4N 3M5 Toronto Western Hospital, University Health NetworkToronto, Ontario, Canada, M5T 2S8 Toronto Liver CentreToronto, Ontario, Canada, M6H 3M1 Toronto Digestive Disease Associates, Inc.Vaughan, Ontario, Canada, L4L 4Y7|Greenfield Park, Quebec, Canada, J4V 2H1 Recherche Gcp ResearchMontreal, Quebec, Canada, H1M 1B1 Centre Hospitalier De L'Universite De Montreal - ChumMontreal, Quebec, Canada, H2X 0A9|Medellin, Antioquia, Colombia, 050034 Ips Rodrigo Botero SasMedellÃ­n, Antioquia, Colombia, 050030|Barranquilla, Atlantico, Colombia, 080020 Fundacion BiosBarranquilla, Atlantico, Colombia, 080020|BogotÃ¡, Cundinamarca, Colombia, 111111 Healthy Medical CenterZipaquira, Cundinamarca, Colombia, 250252|Bogota, Distrito Capital De Bogota, Colombia, 110221|Teusaquillo, Distrito Capital De BogotÃ¡, Colombia, 111311|Villavicencio, Meta, Colombia, 500001|Pereira, Risaralda, Colombia, 660002|Cali, Valle Del Cauca, Colombia, 760001 Ips Centro Medico Julian Coronel S.ACali, Valle Del Cauca, Colombia, 760035|Aalborg, Denmark, 9000|Hellerup, Copenhagen, Denmark, 2900 Gastroenheden, Hvidovre HospitalHvidovre, Copenhagen, Denmark, 2650|Corbeil Essonnes Cedex, France, 91106 GrenobleGrenoble, France, 38043 Hospices Civils De Lyon - HÃ£Â´Pital Edouard HerrriotLyon Cedex 03, France, 69437 Chu NantesNantes Cedex 1, France, 44093 Chu De PoitiersPoitiers, France, 86021 Hopital Charles NicolleRouen Cedex, France, 76031|Pessac, Gironde, France, 33604|VandÅ“uvre-LÃ¨s-Nancy, Grand Est, France, 54500|Colombes, ÃŽle-De-|Karlsruhe, Baden-WÃ£Â¼Rttemberg, Germany, 76137 Praxis Dr. Etzrodt-Walter Und KollegenUlm, Baden-WÃ£Â¼Rttemberg, Germany, 89073|Bad Berleburg, Germany, 57319 Clinical Research Unit/ UniversitÃ£Â¤Tsklinikum Giessen Und Marburg GmbhGiessen, G"}},"Alabama|Arizona|Arkansas|California|Colorado|Connecticut|Florida|Georgia|Idaho|Illinois|Indiana|Iowa|Kansas|Kentucky|Louisiana|Maryland|Massachusetts|Michigan|Montana|Nebraska|Nevada|New Jersey|New Mexico|New York|North Carolina|Ohio|Oklahoma|Oregon|Pennsylvania|Rhode Island|South Carolina|South Dakota|Tennessee|Texas|Utah|Virginia|West Virginia","Argentina|Australia|Austria|Belgium|Brazil|Bulgaria|Canada|Colombia|Denmark|France|Germany|Hungary|India|Israel|Italy|Latvia|Malaysia|Mexico|Philippines|Poland|Romania|South Africa|Spain|Thailand|Ukraine|United Kingdom|United States","Buenos Aires Ciad Moron|Ciudad Autonoma De Buenos Aires Consultorios Asociados De Endocrinologia E Investigacion Cl|Sanatorio Guemes|Santa Fe Instituto De Investigaciones Clinicas De Rosario|New South Wales Nepean Hospital|Queensland Princess Alexandra Hospital|Royal Adelaide Hospital|Victoria The Alfred Hospital|Klinikum Klagenfurt Am WÃ£Â¶Rthersee|Styria Ordination|Tirol Medizinische Universitat Innsbruck|Vorarlberg Vivit Institute, Am Lkh Feldkirch|Antwerp Universitair Ziekenhuis Antwerpen, Gastro-Enterologie,|Brussel Uz Brussel|Hopitaux Iris Sud - Joseph Bracops|West-Vlaanderen Az Sint Lucas Brugge|Ceara Instituto De Estudos E Pesquisas Clinicas Do Ceara Iep/Ce - Oncology|Cpquali Pesquisa Clinica Ltda|Distrito Federal Centro De Pesquisa Clinica Do Brasil|Para Hospital Universitario Joao De Barros Barreto - Ufpa|Parana Ceti - Centro De Estudos Em Terapias Inovadoras|ParÃ£Â¡ Hospital UniversitÃ£Â¡Rio JoÃ£Â£O De Barros Barreto - Ufpa|Rio Grande Do Sul Hospital Sao Vicente De Paulo|Santa Catarina Noova|Sao Paulo Instituto De Pesquisa Clinica De Campinas|Ruse Mhat Yuliya Vrevska Byala|Umhat - Kaspela- Eood|Alberta University Of Calgary|British Columbia Gordon And Leslie Diamond Health Care Centre|Newfoundland And Labrador Eastern Health|Nova Scotia South Shore Medical Arts|Ontario The Ottawa Hospital|Quebec Cisss De La Monteregie-Centre|Antioquia Centro Cardiovascular Colombiano ClÃ­nica Santa MarÃ­a|Atlantico Centro Cardiovascular Y De Diabetes|Cundinamarca Endocare Ltda.|Distrito Capital De Bogota Medplus Medicina Prepagada|Distrito Capital De BogotÃ¡ AsociaciÃ³n Colombiana De Diabetes|Meta Clinica Meta|Risaralda Fundacion Centro De Investigaciones Clinicas Cardiomet|Valle Del Cauca Centro Medico Imbanaco De Cali S.A.|Aalborg University Hospital|Copenhagen Gentofte Hospital|Corbeil Essonnes|Gironde Chu De Bordeaux - HÃ£Â´Pital Haut-LÃ£Â©VÃ£Âªque|Grand Est Chru Nancy|Hopital Louis Mourier, Service D'Hepato Gastro-Enterologie|Baden-WÃ£Â¼Rttemberg Klinische Forschung Karlsruhe Gmbh|Diabetologische Schwerpunktpraxis|Mecklenburg Vorpommern Klinische Forschung Schwerin Gmbh|Niedersachsen Klinische Forschung Hannover-Mitte Gmbh|Saxony Studienzentrum Schwittay|CsonfrÃ£Â¡D First Department Of Medicine, University Of Szeged|Heves Markhot Ferenc Oktatokorhaz Es Rendelointezet|JÃ¡sz-Nagykun-Szolnok Hetenyi Geza Hospital|Semmelweis University|Zala Zala Megyei Szent Rafael Korhaz|Andhra Pradesh King George Hospital|Gujarat Dr. Jivraj Mehta Smarak Health Foundation|Karnataka Lifecare Clinic And Research Centre|Maharashtra Bhatia Hospital|Rajasthan Sp Medical College|Sir Ganga Ram Hospital (Sgrh)|Tamil Nadu Kovai Diabetes Speciality Centre|Telangana Kumudini Devi Diabetes Research Center|Uttar Prandesh M.V Hospital And Research Centre|West Bengal Ipgme&R And Sskm Hospital|Soroka University Medical Center|Lombardy Humanitas Research Hospital|Milan Irccs Policlinico San Donato|Ospedale Cardinal Massaia|Sicily Azienda Ospedaliera Rilievo Nazionale Alta Specialita (Arnas) Garibaldi|Kraslavas Nov. Ogorelova Jelena Gp|Polana-D, Llc|Kedah Hospital Sultanah Bahiyah|Selangor University Malaya Medical Centre, Lembah Pantai|Guanajuato Morales Vargas Centro De Investigacion Sc|Guillermina Hospital De La Paz|Hidalgo Resultados Medicos Desarrollo E Investigacion S.C|Jalisco Consultorio Medico|Morelos Not Yet Instituto De Diabetes Obesidad Y Nutricion Sc|Nuevo Leon Accelerium S. De R.L. De C.V.|Practice Dr Gerardo Gonzalez|Tlalpan Instituto Nacional De Ciencias Medicas Y Nutricion Salvador Zubiran|Veracruz Centro Especializado En Investigacion Clinica S.C.|YucatÃ¡n ClÃ­nica De MÃ©rida|Iloilo West Visayas State University Medical Center|Metro Manila St. Luke's Medical Center|Metropolitan Manila Manila Doctors Hospital, Ermita|Ncr Ospital Ng Makati|Perpetual Succor Hospital|Kuj-Pom Vitamed Galaj I Cichomski Sp.J.|Lublin ZamoÅ›Ä‡|Malopolska Centermed Krakow Ltd|Masovian Oddzial Gastroenterologii Mazowieckie Centrum Rehabilitacji Stocer Sp. Z O.O.|Podlaski Diabet-Med|Podlaskie University Hospital BiaÅ‚ystok|Pomorskie Endoskopia Sp. Z O.O.|Powiatowe Centrum Medyczne W Wolowie Sp. Z O.O.|Specjalistyczny Gabinet Neurologiczny Marta Banach|Warmia-Mazury State Hospital|Oltenia Clintrial Medical Center, Pulmonology Department|Sana Medical Center|, Free State Farmovs|, Gauteng Wits Clinical Research|Synexus Helderberg Clinical Research Centre|Hospital Clinico Universitario San Carlos|Phramongkutklao Hospital|\"|Chernihiv City Hospital No 2 Of Chernihiv City Council|Dnipropetrovsk City Hospital 3|Odesa Region Odesa Regional Clinical Hospital|On The Base Of Pirogov National Medical University|Zaporizhzhia Region Municipal Institution City Hospital No. 7|, East Midland Queens Medical Centre|, Greater Manchester Mac Clinical Research Manchester|, Lancashire Royal Oldham Hospital|, Staffordshire Mac Research, Exchange House|, West Midlands Royal Wolverhampton Nhs Trust|, West Yorkshire Mac Clinical Research, Monarch House|Mac Research|North Alabama Research Center, Llc|Del Sol Research Management, Llc|Chi St. Vincent's Gastroenterology: John Tyler Baber, Md|Hcp Clinical Research Llc|Peak Gastroenterology Associates|Gastroenterology Associates Of Fairfield County, P.C.|Innovative Research Of West Fl, Inc.|Atlanta Diabetes Associates|Rocky Mountain Diabetes And Osteoporosis Center, Pa|North Shore University Health System|Medisphere Medical Research Center, Llc|University Of Iowa Hospitals And Clinics|University Of Kansas Medical Center|Tri-State Gastroenterology|The Center For Clinical Research|Metropolitan Gastroenterology Group Pc, Chevy Chase Clinical Research|Commonwealth Clinical Studies, Pllc.|Clinical Research Institute Of Michigan|Montana Medical Research|Diabetes And Endocrine Associates, P.C.|Clinical Research Of South Nevada - Crosn|Aga Clinical Research Associates Llc|Lovelace Scientific Resources, Inc.|Long Island Gastrointestinal Research Group Llp|Asheville Gastroenterology Associates|Dayton Gastroenterology,Inc.|Digestive Disease Specialists Inc|Northwest Gastroenterology Clinic, Llc|Family Medical Associates, Research Department|Partners In Clinical Research, Llc|Clinical Trials Of South Carolina|Health Concepts|Wr-Clinsearch, Llc|Texas Clinical Research Institute, Llc|Advanced Research Institute, Inc.|Blue Ridge Medical Research|West Virginia University",{"$nulls":3},"Wieslaw (Wes) Bochenek, MD, PhD","2018-12-10","2020-05-25T16:40:18.817","2020-05-26T17:10:42.972","NCT03420781"]
["5ecbf4f3fe30261b1a048420","NCT03420781","2019-02-20","Allergan","AGN","Enrolling by invitation","A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis Study 03","Relamorelin","GHS-R Agonist","Yes","['Relamorelin']","Yes","['GHS-R Agonist']","Phase 3",3,960,"Anticipated","2018-01-24","2020-12-06",{"$nulls":5},"A 46-week study to compare the efficacy of relamorelin with that of placebo in participants with diabetic gastroparesis (DG). At the end of the 40-week Treatment Period, participants will either continue on relamorelin or placebo for 6 additional weeks.",null,"A 46-week, Double-blind, Placebo-controlled, Phase 3 Study With a 6-week Randomized-withdrawal Period to Evaluate the Safety and Efficacy of Relamorelin in Patients With Diabetic Gastroparesis","RLM-MD-03","Gastroparesis\nDiabetes Mellitus","Paresis|Gastroparesis","Neurologic Manifestations|Gastrointestinal Diseases","Central Nervous System|Gastrointestinal","Experimental","Relamorelin 10 Î¼g|Relamorelin 10 Î¼g, followed by Placebo|Placebo, followed by Relamorelin 10 Î¼g","Relamorelin 10 Î¼g injected subcutaneously twice daily for 46 weeks.|Relamorelin 10 Î¼g injected subcutaneously twice daily for 40 weeks, followed by placebo injected twice daily for 6 weeks.|Placebo injected subcutaneously twice daily for 40 weeks, followed by Relamorelin 10 Î¼g injected twice daily for 6 weeks.","Drug","Relamorelin|Placebo","Relamorelin 10 Î¼g injected twice daily for 6, 40 or 46 weeks.|Placebo injected twice daily for 6 weeks or 40 weeks.",null,"Relamorelin 10 Î¼g|Relamorelin 10 Î¼g, followed by Placebo|Placebo, followed by Relamorelin 10 Î¼g","\n\n * Participants are eligible to be included in the study only if all the following criteria apply:\n * Participant met all inclusion/exclusion criteria of either Protocol RLM-MD-01 (NCT03285308) or Protocol RLM-MD-02 (NCT03426345) and successfully completed the study\n * Able to provide written informed consent (IC) prior to any study procedures and willing and able to comply with study procedures\n * In the opinion of the investigator, the participant demonstrated adequate compliance with the study procedures in Study RLM-MD-01 or RLM-MD-02\n\n","\n\n * Participants are excluded from the study if any of the following criteria apply:\n * Participant is not willing or able to abide by the restrictions regarding concomitant medicine use\n * Participant is planning to receive an investigational drug (other than study treatment) or investigational device at any time during Study RLM-MD-03\n * Participant has an unresolved adverse event (AE) or a clinically significant finding on physical examination, clinical laboratory test, or 12-lead electrocardiogram (ECG) that, in the investigator's opinion, would limit the participant's ability to participate in or complete the study\n * Any other reason that, in the investigator's opinion, would confound proper interpretation of the study or expose a participant to unacceptable risk, including renal, hepatic or cardiopulmonary disease",{"$nulls":4},"Actual","2018-02-05","Actual","Anticipated","2020-12-06","Anticipated","2019-02-01","2018-01-24","2018-02-01","2019-02-18","No","diabetic gastroparesis\nvomiting","Interventional","Treatment","Parallel Assignment","Triple (Participant, Care Provider, Investigator)","Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":19},"Diabetic Gastroparesis Symptom Severity Score (DGSSS) Week-12 Responder|Percentage of patients meeting the vomiting symptom responder criterion in each of the last 6 of the 12 weeks of treatment","Patients will assess severity of diabetic gastroparesis symptoms daily using an 11-point ordinal scale with 0 being least and 10 being the worst possible score. Patients will enter the score using an electronic diary.|Vomiting episodes will be patient-recorded daily using an electronic diary.","Baseline to Week 12","Nausea Week 12 Responder|Abdominal Pain Week 12 Responder|Bloating Week 12 Responder|Postprandial Fullness Week 12 Responder|DGSSS Week 40 Responder|DGSSS at Week 40|Vomiting Frequency at Week 40|Vomiting Week-40 Responder|DGSSS at Week 46|Number of Vomiting Episodes at Week 46|Number of Patients who experienced one or more Treatment Emergent Adverse Event (TEAE)","Nausea responder defined as a participant who has at least a 2-point improvement in the weekly symptom score at each of the last 6 weeks of the first 12 weeks of the 40-week Treatment Period. Nausea is assessed on an 11-point ordinal scale from 0 to 10, with 0 meaning no nausea, and 10 meaning the worst possible nausea.|Abdominal pain responder defined as a participant who has at least a 2-point improvement in the weekly symptom score at each of the last 6 weeks of the first 12 weeks of the 40-week Treatment Period. Abdominal Pain is assessed on an 11-point ordinal scale from 0 to 10, with 0 meaning no abdominal Pain, and 10 meaning the worst possible abdominal pain.|Bloating responder defined as a participant who has at least a 2-point improvement in the weekly symptom score at each of the last 6 weeks of the first 12 weeks of the 40-week Treatment Period. Bloating is assessed on an 11-point ordinal scale from 0 to 10, with 0 meaning no bloating, and 10 meaning the worst possible bloating.|Postprandial Fullness responder defined as a participant who has at least a 2-point improvement in the weekly symptom score at each of the last 6 weeks of the first 12 weeks of the 40-week Treatment Period.\n\nPostprandial Fullness is assessed on an 11-point ordinal scale from 0 to 10, with 0 meaning no feeling of fullness until finishing a meal, and 10 meaning felling full after only a few bites.|DGSSS responder defined as a participant who has at least a 10-point improvement in the DGSSS compared to baseline in each of the last 4 weeks of the 40-week Treatment Period.|Change from baseline to Week 40 in average weekly DGSSS. Average weekly scores are derived as the average of the weekly scores from the four weeks prior to Week 40 (Visit 7) in this study.|Change from baseline to Week 40 in average weekly number of vomiting episodes derived as the average of the weekly number of vomiting episodes during the four weeks prior to Week 40 (Visit 7) in this study.|Vomiting responder defined as a participant with zero weekly vomiting episodes during each of the last 4 weeks of the 40-week Treatment Period.|Change from baseline (CFB) to end of Randomized withdrawl period (RWP) in the average weekly DGSSS. Average weekly scores are derived as the average of the weekly scores from the six weeks of the RWP.|CFB to end of RWP in the average weekly number of vomiting episodes. Average weekly scores are derived as the average of the weekly number of vomiting episodes from the six weeks of the RWP.|The number of patients who experienced one or more TEAE during the 46 week treatment period.","Baseline to Week 12|Baseline to Week 40|Baseline to Week 46",{"$nulls":3},{"$cut":{"chars":26245,"head":"Mar Del Plata, Buenos Aires, Argentina, B7600Fyk Ciad MoronMoron, Buenos Aires, Argentina, 1708|Buenos Aires, Ciudad Autonoma De Buenos Aires, Argentina, C1425Agc|Buenos Aires, Argentina, C1419Ahn Sanatorio GuemesCaba, Argentina, C1180 Aax CiprecCiudad Autonoma De Buenos Aires, Argentina, 1119 IlaimCordoba, Argentina, X5000Bnb Centro Universitario De Investigacion En Farmacologia ClinicCorrientes, Argentina, W3410Avv Instituto De Investigaciones Clinicas CbaCÃ³rdoba, Argentina, X5000Aaw|Rosario, Santa Fe, Argentina, 2000 Instituto De Hematologia Y Medicina Clinica Dr. Ruben DavoliRosario, Santa Fe, Argentina, S200Cfk|San Miguel De Tucuman, Tucuman, Argentina, 4000|Kingswood, New South Wales, Australia, 2747|Woolloongabba, Queensland, Australia, 4102|Adelaide, South|Melbourne, Victoria, Australia, 3004 Royal Melbourne HospitalParkville, Victoria, Australia, 3050|Klagenfurt, Austria, 9020 Privatklinik Wehrle-DiakonissenSalzburg, Austria, 5020 Gesundheits- Und Spitals-Ag/Lkh SteyrSteyr, Austria, 4400|Sankt Stefan Ob Stainz, Styria, Austria, 8511|Innsbruck, Tirol, Austria, A-6020|Feldkirch`, Vorarlberg, Austria, 6807|Edegem, Antwerp, Belgium, 2650|Jette, Brussel, Belgium, 1090|Brussels, Belgium, 1070|Brugge, West-Vlaanderen, Belgium, 8310|Fortaleza, Ceara, Brazil, 60160-230 Hospital Universitario Walter CantadioFortaleza, Ceara, Brazil, 60430270|Sao Paulo, Brazil, 01228-000 Universidade De Sao Paulo (Usp) - Hospital Das Clinicas Da FSao Paulo, Brazil, 5403000 Instituto De Pesquisa ClÃ­nica E Medicina Avancada LtdaSÃ£o Paulo, Brazil, 01223-001|Brasilia, Distrito Federal, Brazil, 71625175|BelÃ©m, Para, Brazil, 66073-000|Curitiba, Parana, Brazil, 80030-110|BelÃ£Â©M, ParÃ£Â¡, Brazil, 66073-000|Passo Fundo, Rio Grande Do Sul, Brazil, 99010-080 Hospital De Clinicas De Porto AlegrePorto Alegre, Rio Grande Do Sul, Brazil, 90035-003 Hospital Sao Lucas Da Puc-RsPorto Alegre, Rio Grande Do Sul, Brazil, 90610-000|FlorianÃ³polis, Santa Catarina, Brazil, 88015-230 Instituto Catarinense De Endocrinologia E Diabetes (Iced)Joinville, Santa Catarina, Brazil, 89201-260|Campinas, Sao Paulo, Brazil, 13060904|Campinas, SÃ£o Paulo, Brazil, 13020-431|Byala, Ruse, Bulgaria, 7100|Plovdiv, Bulgaria, 4002 Medical Center Asklepion - Humane Medicine Research EoodSofia, Bulgaria, 1303 Alexandrovska University HospitalSofia, Bulgaria, 1431|Calgary, Alberta, Canada, T2N 2T9 Alberta Diabetes InstituteEdmonton, Alberta, Canada, T6G 2E1 The Bailey ClinicRed Deer, Alberta, Canada, T4N 6V7|Vancouver, British Columbia, Canada, V5Z 1M9|St. John'S, Newfoundland And Labrador, Canada, A1B 3V6|Bridgewater, Nova Scotia, Canada, B4V 2V6|Ottawa, Ontario, Canada, K1H 7W9 Sunnybrook Health Science CentreToronto, Ontario, Canada, M4N 3M5 Toronto Western Hospital, University Health NetworkToronto, Ontario, Canada, M5T 2S8 Toronto Liver CentreToronto, Ontario, Canada, M6H 3M1 Toronto Digestive Disease Associates, Inc.Vaughan, Ontario, Canada, L4L 4Y7|Greenfield Park, Quebec, Canada, J4V 2H1 Recherche Gcp ResearchMontreal, Quebec, Canada, H1M 1B1 Centre Hospitalier De L'Universite De Montreal - ChumMontreal, Quebec, Canada, H2X 0A9|Medellin, Antioquia, Colombia, 050034 Ips Rodrigo Botero SasMedellÃ­n, Antioquia, Colombia, 050030|Barranquilla, Atlantico, Colombia, 080020 Fundacion BiosBarranquilla, Atlantico, Colombia, 080020|BogotÃ¡, Cundinamarca, Colombia, 111111 Healthy Medical CenterZipaquira, Cundinamarca, Colombia, 250252|Bogota, Distrito Capital De Bogota, Colombia, 110221|Teusaquillo, Distrito Capital De BogotÃ¡, Colombia, 111311|Villavicencio, Meta, Colombia, 500001|Pereira, Risaralda, Colombia, 660002 Fundacion Centro De Investigaciones Clinicas CardiometPereira, Risaralda, Colombia, Not Yet Recruiting|Cali, Valle Del Cauca, Colombia, 760001 Ips Centro Medico Julian Coronel S.ACali, Valle Del Cauca, Colombia, 760035|Aalborg, Denmark, 9000|Hellerup, Copenhagen, Denmark, 2900 Gastroenheden, Hvidovre HospitalHvidovre, Copenhagen, Denmark, 2650|Corbeil Essonnes Cedex, France, 91106 GrenobleGrenoble, France, 38043 Hospices Civils De Lyon - HÃ£Â´Pital Edouard HerrriotLyon C"}},"Alabama|Arizona|Arkansas|California|Colorado|Connecticut|Florida|Georgia|Idaho|Illinois|Indiana|Iowa|Kansas|Kentucky|Louisiana|Maryland|Massachusetts|Michigan|Montana|Nebraska|Nevada|New Jersey|New Mexico|New York|North Carolina|Ohio|Oklahoma|Oregon|Pennsylvania|Rhode Island|South Carolina|South Dakota|Tennessee|Texas|Utah|Virginia|Washington|West Virginia","Argentina|Australia|Austria|Belgium|Brazil|Bulgaria|Canada|Colombia|Denmark|France|Germany|Hungary|India|Israel|Italy|Latvia|Malaysia|Mexico|Philippines|Poland|Romania|Saudi Arabia|South Africa|Spain|Thailand|Ukraine|United Kingdom|United States","Buenos Aires Centro De Investigaciones Medicas Mar Del Plata Srl|Ciudad Autonoma De Buenos Aires Consultorios Asociados De Endocrinologia E Investigacion Cl|Hospital Sirio Libanes|Santa Fe Instituto De Investigaciones Clinicas De Rosario|Tucuman Centro Modelo De Cardiologia|New South Wales Nepean Hospital|Queensland Princess Alexandra Hospital|Royal Adelaide Hospital|Victoria The Alfred Hospital|Klinikum Klagenfurt Am WÃ£Â¶Rthersee|Styria Ordination|Tirol Medizinische Universitat Innsbruck|Vorarlberg Vivit Institute, Am Lkh Feldkirch|Antwerp Universitair Ziekenhuis Antwerpen, Gastro-Enterologie,|Brussel Uz Brussel|Hopitaux Iris Sud - Joseph Bracops|West-Vlaanderen Az Sint Lucas Brugge|Ceara Instituto De Estudos E Pesquisas Clinicas Do Ceara Iep/Ce - Oncology|Cpquali Pesquisa Clinica Ltda|Distrito Federal Centro De Pesquisa Clinica Do Brasil|Para Hospital Universitario Joao De Barros Barreto - Ufpa|Parana Ceti - Centro De Estudos Em Terapias Inovadoras|ParÃ£Â¡ Hospital UniversitÃ£Â¡Rio JoÃ£Â£O De Barros Barreto - Ufpa|Rio Grande Do Sul Hospital Sao Vicente De Paulo|Santa Catarina Noova|Sao Paulo Instituto De Pesquisa Clinica De Campinas|SÃ£o Paulo Scentryphar Pesquisa Clinica Ltda|Ruse Mhat Yuliya Vrevska Byala|Umhat - Kaspela- Eood|Alberta University Of Calgary|British Columbia Gordon And Leslie Diamond Health Care Centre|Newfoundland And Labrador Eastern Health|Nova Scotia South Shore Medical Arts|Ontario The Ottawa Hospital|Quebec Cisss De La Monteregie-Centre|Antioquia Centro Cardiovascular Colombiano ClÃ­nica Santa MarÃ­a|Atlantico Centro Cardiovascular Y De Diabetes|Cundinamarca Endocare Ltda.|Distrito Capital De Bogota Medplus Medicina Prepagada|Distrito Capital De BogotÃ¡ AsociaciÃ³n Colombiana De Diabetes|Meta Clinica Meta|Risaralda Fundacion Centro De Investigaciones Clinicas Cardiomet|Valle Del Cauca Centro Medico Imbanaco De Cali S.A.|Aalborg University Hospital|Copenhagen Gentofte Hospital|Corbeil Essonnes|Gironde Chu De Bordeaux - HÃ£Â´Pital Haut-LÃ£Â©VÃ£Âªque|Grand Est Chru Nancy|Hopital Louis Mourier, Service D'Hepato Gastro-Enterologie|Baden-WÃ£Â¼Rttemberg Klinische Forschung Karlsruhe Gmbh|Diabetologische Schwerpunktpraxis|Mecklenburg Vorpommern Klinische Forschung Schwerin Gmbh|Niedersachsen Klinische Forschung Hannover-Mitte Gmbh|Saxony Studienzentrum Schwittay|CsonfrÃ£Â¡D First Department Of Medicine, University Of Szeged|Heves Markhot Ferenc Oktatokorhaz Es Rendelointezet|JÃ¡sz-Nagykun-Szolnok Hetenyi Geza Hospital|StrÃ£Æ’Ã¢Â¡Zshegy Medicina|Zala Zala Megyei Szent Rafael Korhaz|Andhra Pradesh King George Hospital|Gujarat Dr. Jivraj Mehta Smarak Health Foundation|Karnataka Lifecare Clinic And Research Centre|M. S. Ramaiah Medical College And Hospitals|Maharashtra Bhatia Hospital|Rajasthan Sp Medical College|Tamil Nadu Kovai Diabetes Speciality Centre|Telangana Kumudini Devi Diabetes Research Center|Uttar Prandesh M.V Hospital And Research Centre|West Bengal Ipgme&R And Sskm Hospital|Soroka University Medical Center|Lombardy Humanitas Research Hospital|Milan Irccs Policlinico San Donato|Ospedale Cardinal Massaia|Sicily Azienda Ospedaliera Rilievo Nazionale Alta Specialita (Arnas) Garibaldi|Kraslavas Nov. Ogorelova Jelena Gp|Polana-D, Llc|Kedah Hospital Sultanah Bahiyah|Selangor University Malaya Medical Centre, Lembah Pantai|Guanajuato Morales Vargas Centro De Investigacion Sc|Guillermina Hospital De La Paz|Hidalgo Resultados Medicos Desarrollo E Investigacion S.C|Jalisco Consultorio Medico|Morelos Not Yet Instituto De Diabetes Obesidad Y Nutricion Sc|Nuevo Leon Accelerium S. De R.L. De C.V.|Practice Dr Gerardo Gonzalez|Tlalpan Instituto Nacional De Ciencias Medicas Y Nutricion Salvador Zubiran|Veracruz Centro Especializado En Investigacion Clinica S.C.|YucatÃ¡n ClÃ­nica De MÃ©rida|Iloilo West Visayas State University Medical Center|Metro Manila St. Luke's Medical Center|Metropolitan Manila Manila Doctors Hospital, Ermita|Ncr Ospital Ng Makati|Perpetual Succor Hospital|Lublin ZamoÅ›Ä‡|Malopolska Centermed Krakow Ltd|Masovian Oddzial Gastroenterologii Mazowieckie Centrum Rehabilitacji Stocer Sp. Z O.O.|Podlaski Diabet-Med|Podlaskie University Hospital BiaÅ‚ystok|Pomorskie Endoskopia Sp. Z O.O.|Powiatowe Centrum Medyczne W Wolowie Sp. Z O.O.|Specjalistyczny Gabinet Neurologiczny Marta Banach|Warmia-Mazury State Hospital|Oltenia Clintrial Medical Center, Pulmonology Department|Sana Medical Center|Hayyal Jamia Hospital|, Free State Farmovs|, Gauteng Wits Clinical Research|Synexus Helderberg Clinical Research Centre|Hospital Clinico Universitario San Carlos|Phramongkutklao Hospital|\"|Chernihiv City Hospital No 2 Of Chernihiv City Council|Dnipropetrovsk City Hospital 3|Odesa Region Odesa Regional Clinical Hospital|On The Base Of Pirogov National Medical University|Zaporizhzhia Region Municipal Institution City Hospital No. 7|, East Midland Queens Medical Centre|, Greater Manchester Mac Clinical Research Manchester|, Lancashire Royal Oldham Hospital|, Staffordshire Mac Research, Exchange House|, West Midlands Royal Wolverhampton Nhs Trust|, West Yorkshire Mac Clinical Research, Monarch House|Mac Research|North Alabama Research Center, Llc|Del Sol Research Management, Llc|Chi St. Vincent's Gastroenterology: John Tyler Baber, Md|Hope Clinical Research|University Of Colorado, Denver|Gastroenterology Associates Of Fairfield County, P.C.|Innovative Research Of West Fl, Inc.|Atlanta Diabetes Associates|Rocky Mountain Diabetes And Osteoporosis Center, Pa|North Shore University Health System|Medisphere Medical Research Center, Llc|University Of Iowa Hospitals And Clinics|University Of Kansas Medical Center|Tri-State Gastroenterology|The Center For Clinical Research|Metropolitan Gastroenterology Group Pc, Chevy Chase Clinical Research|Commonwealth Clinical Studies, Pllc.|Clinical Research Institute Of Michigan|Montana Medical Research|Diabetes And Endocrine Associates, P.C.|Clinical Research Of South Nevada - Crosn|Garden State Endocrinology|Lovelace Scientific Resources, Inc.|Long Island Gastrointestinal Research Group Llp|Asheville Gastroenterology Associates|Dayton Gastroenterology,Inc.|Digestive Disease Specialists Inc|Northwest Gastroenterology Clinic, Llc|Family Medical Associates, Research Department|Partners In Clinical Research, Llc|Clinical Trials Of South Carolina|Health Concepts|Wr-Clinsearch, Llc|Texas Clinical Research Institute, Llc|Advanced Research Institute, Inc.|Verity Research Inc.|Washington Gastroenterology Pllc|West Virginia University",{"$nulls":3},"Wieslaw (Wes) Bochenek, MD, PhD","2019-02-18","2020-05-25T16:40:19.230","2020-05-26T17:10:42.972","NCT03420781"]
["5ecbf4f3e2561b1b11905f1a","NCT03420781","2019-02-21","Allergan","AGN","Enrolling by invitation","A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis Study 03","Relamorelin","GHS-R Agonist","Yes","['Relamorelin']","Yes","['GHS-R Agonist']","Phase 3",3,960,"Anticipated","2018-01-24","2020-12-06",{"$nulls":5},"A 46-week study to compare the efficacy of relamorelin with that of placebo in participants with diabetic gastroparesis (DG). At the end of the 40-week Treatment Period, participants will either continue on relamorelin or placebo for 6 additional weeks.",null,"A 46-week, Double-blind, Placebo-controlled, Phase 3 Study With a 6-week Randomized-withdrawal Period to Evaluate the Safety and Efficacy of Relamorelin in Patients With Diabetic Gastroparesis","RLM-MD-03","Gastroparesis\nDiabetes Mellitus","Paresis|Gastroparesis","Neurologic Manifestations|Gastrointestinal Diseases","Central Nervous System|Gastrointestinal","Experimental","Relamorelin 10 Î¼g|Relamorelin 10 Î¼g, followed by Placebo|Placebo, followed by Relamorelin 10 Î¼g","Relamorelin 10 Î¼g injected subcutaneously twice daily for 46 weeks.|Relamorelin 10 Î¼g injected subcutaneously twice daily for 40 weeks, followed by placebo injected twice daily for 6 weeks.|Placebo injected subcutaneously twice daily for 40 weeks, followed by Relamorelin 10 Î¼g injected twice daily for 6 weeks.","Drug","Relamorelin|Placebo","Relamorelin 10 Î¼g injected twice daily for 6, 40 or 46 weeks.|Placebo injected twice daily for 6 weeks or 40 weeks.",null,"Relamorelin 10 Î¼g|Relamorelin 10 Î¼g, followed by Placebo|Placebo, followed by Relamorelin 10 Î¼g","\n\n * Participants are eligible to be included in the study only if all the following criteria apply:\n * Participant met all inclusion/exclusion criteria of either Protocol RLM-MD-01 (NCT03285308) or Protocol RLM-MD-02 (NCT03426345) and successfully completed the study\n * Able to provide written informed consent (IC) prior to any study procedures and willing and able to comply with study procedures\n * In the opinion of the investigator, the participant demonstrated adequate compliance with the study procedures in Study RLM-MD-01 or RLM-MD-02\n\n","\n\n * Participants are excluded from the study if any of the following criteria apply:\n * Participant is not willing or able to abide by the restrictions regarding concomitant medicine use\n * Participant is planning to receive an investigational drug (other than study treatment) or investigational device at any time during Study RLM-MD-03\n * Participant has an unresolved adverse event (AE) or a clinically significant finding on physical examination, clinical laboratory test, or 12-lead electrocardiogram (ECG) that, in the investigator's opinion, would limit the participant's ability to participate in or complete the study\n * Any other reason that, in the investigator's opinion, would confound proper interpretation of the study or expose a participant to unacceptable risk, including renal, hepatic or cardiopulmonary disease",{"$nulls":4},"Actual","2018-02-05","Actual","Anticipated","2020-12-06","Anticipated","2019-02-01","2018-01-24","2018-02-01","2019-02-20","No","diabetic gastroparesis\nvomiting","Interventional","Treatment","Parallel Assignment","Triple (Participant, Care Provider, Investigator)","Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":19},"Diabetic Gastroparesis Symptom Severity Score (DGSSS) Week-12 Responder|Percentage of patients meeting the vomiting symptom responder criterion in each of the last 6 of the 12 weeks of treatment","Patients will assess severity of diabetic gastroparesis symptoms daily using an 11-point ordinal scale with 0 being least and 10 being the worst possible score. Patients will enter the score using an electronic diary.|Vomiting episodes will be patient-recorded daily using an electronic diary.","Baseline to Week 12","Nausea Week 12 Responder|Abdominal Pain Week 12 Responder|Bloating Week 12 Responder|Postprandial Fullness Week 12 Responder|DGSSS Week 40 Responder|DGSSS at Week 40|Vomiting Frequency at Week 40|Vomiting Week-40 Responder|DGSSS at Week 46|Number of Vomiting Episodes at Week 46|Number of Patients who experienced one or more Treatment Emergent Adverse Event (TEAE)","Nausea responder defined as a participant who has at least a 2-point improvement in the weekly symptom score at each of the last 6 weeks of the first 12 weeks of the 40-week Treatment Period. Nausea is assessed on an 11-point ordinal scale from 0 to 10, with 0 meaning no nausea, and 10 meaning the worst possible nausea.|Abdominal pain responder defined as a participant who has at least a 2-point improvement in the weekly symptom score at each of the last 6 weeks of the first 12 weeks of the 40-week Treatment Period. Abdominal Pain is assessed on an 11-point ordinal scale from 0 to 10, with 0 meaning no abdominal Pain, and 10 meaning the worst possible abdominal pain.|Bloating responder defined as a participant who has at least a 2-point improvement in the weekly symptom score at each of the last 6 weeks of the first 12 weeks of the 40-week Treatment Period. Bloating is assessed on an 11-point ordinal scale from 0 to 10, with 0 meaning no bloating, and 10 meaning the worst possible bloating.|Postprandial Fullness responder defined as a participant who has at least a 2-point improvement in the weekly symptom score at each of the last 6 weeks of the first 12 weeks of the 40-week Treatment Period.\n\nPostprandial Fullness is assessed on an 11-point ordinal scale from 0 to 10, with 0 meaning no feeling of fullness until finishing a meal, and 10 meaning felling full after only a few bites.|DGSSS responder defined as a participant who has at least a 10-point improvement in the DGSSS compared to baseline in each of the last 4 weeks of the 40-week Treatment Period.|Change from baseline to Week 40 in average weekly DGSSS. Average weekly scores are derived as the average of the weekly scores from the four weeks prior to Week 40 (Visit 7) in this study.|Change from baseline to Week 40 in average weekly number of vomiting episodes derived as the average of the weekly number of vomiting episodes during the four weeks prior to Week 40 (Visit 7) in this study.|Vomiting responder defined as a participant with zero weekly vomiting episodes during each of the last 4 weeks of the 40-week Treatment Period.|Change from baseline (CFB) to end of Randomized withdrawl period (RWP) in the average weekly DGSSS. Average weekly scores are derived as the average of the weekly scores from the six weeks of the RWP.|CFB to end of RWP in the average weekly number of vomiting episodes. Average weekly scores are derived as the average of the weekly number of vomiting episodes from the six weeks of the RWP.|The number of patients who experienced one or more TEAE during the 46 week treatment period.","Baseline to Week 12|Baseline to Week 40|Baseline to Week 46",{"$nulls":3},{"$cut":{"chars":26224,"head":"Mar Del Plata, Buenos Aires, Argentina, B7600Fyk Ciad MoronMoron, Buenos Aires, Argentina, 1708|Buenos Aires, Ciudad Autonoma De Buenos Aires, Argentina, C1425Agc|Buenos Aires, Argentina, C1419Ahn Sanatorio GuemesCaba, Argentina, C1180 Aax CiprecCiudad Autonoma De Buenos Aires, Argentina, 1119 IlaimCordoba, Argentina, X5000Bnb Centro Universitario De Investigacion En Farmacologia ClinicCorrientes, Argentina, W3410Avv Instituto De Investigaciones Clinicas CbaCÃ³rdoba, Argentina, X5000Aaw|Rosario, Santa Fe, Argentina, 2000 Instituto De Hematologia Y Medicina Clinica Dr. Ruben DavoliRosario, Santa Fe, Argentina, S200Cfk|San Miguel De Tucuman, Tucuman, Argentina, 4000|Kingswood, New South Wales, Australia, 2747|Woolloongabba, Queensland, Australia, 4102|Adelaide, South|Melbourne, Victoria, Australia, 3004 Royal Melbourne HospitalParkville, Victoria, Australia, 3050|Klagenfurt, Austria, 9020 Privatklinik Wehrle-DiakonissenSalzburg, Austria, 5020 Gesundheits- Und Spitals-Ag/Lkh SteyrSteyr, Austria, 4400|Sankt Stefan Ob Stainz, Styria, Austria, 8511|Innsbruck, Tirol, Austria, A-6020|Feldkirch`, Vorarlberg, Austria, 6807|Edegem, Antwerp, Belgium, 2650|Jette, Brussel, Belgium, 1090|Brussels, Belgium, 1070|Brugge, West-Vlaanderen, Belgium, 8310|Fortaleza, Ceara, Brazil, 60160-230 Hospital Universitario Walter CantadioFortaleza, Ceara, Brazil, 60430270|Sao Paulo, Brazil, 01228-000 Universidade De Sao Paulo (Usp) - Hospital Das Clinicas Da FSao Paulo, Brazil, 5403000 Instituto De Pesquisa ClÃ­nica E Medicina Avancada LtdaSÃ£o Paulo, Brazil, 01223-001|Brasilia, Distrito Federal, Brazil, 71625175|BelÃ©m, Para, Brazil, 66073-000|Curitiba, Parana, Brazil, 80030-110|BelÃ£Â©M, ParÃ£Â¡, Brazil, 66073-000|Passo Fundo, Rio Grande Do Sul, Brazil, 99010-080 Hospital De Clinicas De Porto AlegrePorto Alegre, Rio Grande Do Sul, Brazil, 90035-003 Hospital Sao Lucas Da Puc-RsPorto Alegre, Rio Grande Do Sul, Brazil, 90610-000|FlorianÃ³polis, Santa Catarina, Brazil, 88015-230 Instituto Catarinense De Endocrinologia E Diabetes (Iced)Joinville, Santa Catarina, Brazil, 89201-260|Campinas, Sao Paulo, Brazil, 13060904|Campinas, SÃ£o Paulo, Brazil, 13020-431|Byala, Ruse, Bulgaria, 7100|Plovdiv, Bulgaria, 4002 Medical Center Asklepion - Humane Medicine Research EoodSofia, Bulgaria, 1303 Alexandrovska University HospitalSofia, Bulgaria, 1431|Calgary, Alberta, Canada, T2N 2T9 Alberta Diabetes InstituteEdmonton, Alberta, Canada, T6G 2E1 The Bailey ClinicRed Deer, Alberta, Canada, T4N 6V7|Vancouver, British Columbia, Canada, V5Z 1M9|St. John'S, Newfoundland And Labrador, Canada, A1B 3V6|Bridgewater, Nova Scotia, Canada, B4V 2V6|Ottawa, Ontario, Canada, K1H 7W9 Sunnybrook Health Science CentreToronto, Ontario, Canada, M4N 3M5 Toronto Western Hospital, University Health NetworkToronto, Ontario, Canada, M5T 2S8 Toronto Liver CentreToronto, Ontario, Canada, M6H 3M1 Toronto Digestive Disease Associates, Inc.Vaughan, Ontario, Canada, L4L 4Y7|Greenfield Park, Quebec, Canada, J4V 2H1 Recherche Gcp ResearchMontreal, Quebec, Canada, H1M 1B1 Centre Hospitalier De L'Universite De Montreal - ChumMontreal, Quebec, Canada, H2X 0A9|Medellin, Antioquia, Colombia, 050034 Ips Rodrigo Botero SasMedellÃ­n, Antioquia, Colombia, 050030|Barranquilla, Atlantico, Colombia, 080020 Fundacion BiosBarranquilla, Atlantico, Colombia, 080020|BogotÃ¡, Cundinamarca, Colombia, 111111 Healthy Medical CenterZipaquira, Cundinamarca, Colombia, 250252|Bogota, Distrito Capital De Bogota, Colombia, 110221|Teusaquillo, Distrito Capital De BogotÃ¡, Colombia, 111311|Villavicencio, Meta, Colombia, 500001|Pereira, Risaralda, Colombia, 660002 Fundacion Centro De Investigaciones Clinicas CardiometPereira, Risaralda, Colombia, Not Yet Recruiting|Cali, Valle Del Cauca, Colombia, 760001 Ips Centro Medico Julian Coronel S.ACali, Valle Del Cauca, Colombia, 760035|Aalborg, Denmark, 9000|Hellerup, Copenhagen, Denmark, 2900 Gastroenheden, Hvidovre HospitalHvidovre, Copenhagen, Denmark, 2650|Corbeil Essonnes Cedex, France, 91106 GrenobleGrenoble, France, 38043 Hospices Civils De Lyon - HÃ£Â´Pital Edouard HerrriotLyon C"}},"Alabama|Arizona|Arkansas|California|Colorado|Connecticut|Florida|Georgia|Idaho|Illinois|Indiana|Iowa|Kansas|Kentucky|Louisiana|Maryland|Massachusetts|Michigan|Montana|Nebraska|Nevada|New Jersey|New Mexico|New York|North Carolina|Ohio|Oklahoma|Oregon|Pennsylvania|Rhode Island|South Carolina|South Dakota|Tennessee|Texas|Utah|Virginia|Washington|West Virginia","Argentina|Australia|Austria|Belgium|Brazil|Bulgaria|Canada|Colombia|Denmark|France|Germany|Hungary|India|Israel|Italy|Latvia|Malaysia|Mexico|Philippines|Poland|Romania|South Africa|Spain|Thailand|Ukraine|United Kingdom|United States","Buenos Aires Centro De Investigaciones Medicas Mar Del Plata Srl|Ciudad Autonoma De Buenos Aires Consultorios Asociados De Endocrinologia E Investigacion Cl|Hospital Sirio Libanes|Santa Fe Instituto De Investigaciones Clinicas De Rosario|Tucuman Centro Modelo De Cardiologia|New South Wales Nepean Hospital|Queensland Princess Alexandra Hospital|Royal Adelaide Hospital|Victoria The Alfred Hospital|Klinikum Klagenfurt Am WÃ£Â¶Rthersee|Styria Ordination|Tirol Medizinische Universitat Innsbruck|Vorarlberg Vivit Institute, Am Lkh Feldkirch|Antwerp Universitair Ziekenhuis Antwerpen, Gastro-Enterologie,|Brussel Uz Brussel|Hopitaux Iris Sud - Joseph Bracops|West-Vlaanderen Az Sint Lucas Brugge|Ceara Instituto De Estudos E Pesquisas Clinicas Do Ceara Iep/Ce - Oncology|Cpquali Pesquisa Clinica Ltda|Distrito Federal Centro De Pesquisa Clinica Do Brasil|Para Hospital Universitario Joao De Barros Barreto - Ufpa|Parana Ceti - Centro De Estudos Em Terapias Inovadoras|ParÃ£Â¡ Hospital UniversitÃ£Â¡Rio JoÃ£Â£O De Barros Barreto - Ufpa|Rio Grande Do Sul Hospital Sao Vicente De Paulo|Santa Catarina Noova|Sao Paulo Instituto De Pesquisa Clinica De Campinas|SÃ£o Paulo Scentryphar Pesquisa Clinica Ltda|Ruse Mhat Yuliya Vrevska Byala|Umhat - Kaspela- Eood|Alberta University Of Calgary|British Columbia Gordon And Leslie Diamond Health Care Centre|Newfoundland And Labrador Eastern Health|Nova Scotia South Shore Medical Arts|Ontario The Ottawa Hospital|Quebec Cisss De La Monteregie-Centre|Antioquia Centro Cardiovascular Colombiano ClÃ­nica Santa MarÃ­a|Atlantico Centro Cardiovascular Y De Diabetes|Cundinamarca Endocare Ltda.|Distrito Capital De Bogota Medplus Medicina Prepagada|Distrito Capital De BogotÃ¡ AsociaciÃ³n Colombiana De Diabetes|Meta Clinica Meta|Risaralda Fundacion Centro De Investigaciones Clinicas Cardiomet|Valle Del Cauca Centro Medico Imbanaco De Cali S.A.|Aalborg University Hospital|Copenhagen Gentofte Hospital|Corbeil Essonnes|Gironde Chu De Bordeaux - HÃ£Â´Pital Haut-LÃ£Â©VÃ£Âªque|Grand Est Chru Nancy|Hopital Louis Mourier, Service D'Hepato Gastro-Enterologie|Baden-WÃ£Â¼Rttemberg Klinische Forschung Karlsruhe Gmbh|Diabetologische Schwerpunktpraxis|Mecklenburg Vorpommern Klinische Forschung Schwerin Gmbh|Niedersachsen Klinische Forschung Hannover-Mitte Gmbh|Saxony Studienzentrum Schwittay|CsonfrÃ£Â¡D First Department Of Medicine, University Of Szeged|Heves Markhot Ferenc Oktatokorhaz Es Rendelointezet|JÃ¡sz-Nagykun-Szolnok Hetenyi Geza Hospital|StrÃ£Æ’Ã¢Â¡Zshegy Medicina|Zala Zala Megyei Szent Rafael Korhaz|Andhra Pradesh King George Hospital|Gujarat Dr. Jivraj Mehta Smarak Health Foundation|Karnataka Lifecare Clinic And Research Centre|M. S. Ramaiah Medical College And Hospitals|Maharashtra Bhatia Hospital|Rajasthan Sp Medical College|Tamil Nadu Kovai Diabetes Speciality Centre|Telangana Kumudini Devi Diabetes Research Center|Uttar Prandesh M.V Hospital And Research Centre|West Bengal Ipgme&R And Sskm Hospital|Soroka University Medical Center|Lombardy Humanitas Research Hospital|Milan Irccs Policlinico San Donato|Ospedale Cardinal Massaia|Sicily Azienda Ospedaliera Rilievo Nazionale Alta Specialita (Arnas) Garibaldi|Kraslavas Nov. Ogorelova Jelena Gp|Polana-D, Llc|Kedah Hospital Sultanah Bahiyah|Selangor University Malaya Medical Centre, Lembah Pantai|Guanajuato Morales Vargas Centro De Investigacion Sc|Guillermina Hospital De La Paz|Hidalgo Resultados Medicos Desarrollo E Investigacion S.C|Jalisco Consultorio Medico|Morelos Not Yet Instituto De Diabetes Obesidad Y Nutricion Sc|Nuevo Leon Accelerium S. De R.L. De C.V.|Practice Dr Gerardo Gonzalez|Tlalpan Instituto Nacional De Ciencias Medicas Y Nutricion Salvador Zubiran|Veracruz Centro Especializado En Investigacion Clinica S.C.|YucatÃ¡n ClÃ­nica De MÃ©rida|Iloilo West Visayas State University Medical Center|Metro Manila St. Luke's Medical Center|Metropolitan Manila Manila Doctors Hospital, Ermita|Ncr Ospital Ng Makati|Perpetual Succor Hospital|Lublin ZamoÅ›Ä‡|Malopolska Centermed Krakow Ltd|Masovian Oddzial Gastroenterologii Mazowieckie Centrum Rehabilitacji Stocer Sp. Z O.O.|Podlaski Diabet-Med|Podlaskie University Hospital BiaÅ‚ystok|Pomorskie Endoskopia Sp. Z O.O.|Powiatowe Centrum Medyczne W Wolowie Sp. Z O.O.|Specjalistyczny Gabinet Neurologiczny Marta Banach|Warmia-Mazury State Hospital|Oltenia Clintrial Medical Center, Pulmonology Department|Sana Medical Center|, Free State Farmovs|, Gauteng Wits Clinical Research|Synexus Helderberg Clinical Research Centre|Hospital Clinico Universitario San Carlos|Phramongkutklao Hospital|\"|Chernihiv City Hospital No 2 Of Chernihiv City Council|Dnipropetrovsk City Hospital 3|Odesa Region Odesa Regional Clinical Hospital|On The Base Of Pirogov National Medical University|Zaporizhzhia Region Municipal Institution City Hospital No. 7|, East Midland Queens Medical Centre|, Greater Manchester Mac Clinical Research Manchester|, Lancashire Royal Oldham Hospital|, Staffordshire Mac Research, Exchange House|, West Midlands Royal Wolverhampton Nhs Trust|, West Yorkshire Mac Clinical Research, Monarch House|Mac Research|North Alabama Research Center, Llc|Del Sol Research Management, Llc|Chi St. Vincent's Gastroenterology: John Tyler Baber, Md|Hope Clinical Research|University Of Colorado, Denver|Gastroenterology Associates Of Fairfield County, P.C.|Innovative Research Of West Fl, Inc.|Atlanta Diabetes Associates|Rocky Mountain Diabetes And Osteoporosis Center, Pa|North Shore University Health System|Medisphere Medical Research Center, Llc|University Of Iowa Hospitals And Clinics|University Of Kansas Medical Center|Tri-State Gastroenterology|The Center For Clinical Research|Metropolitan Gastroenterology Group Pc, Chevy Chase Clinical Research|Commonwealth Clinical Studies, Pllc.|Clinical Research Institute Of Michigan|Montana Medical Research|Diabetes And Endocrine Associates, P.C.|Clinical Research Of South Nevada - Crosn|Garden State Endocrinology|Lovelace Scientific Resources, Inc.|Long Island Gastrointestinal Research Group Llp|Asheville Gastroenterology Associates|Dayton Gastroenterology,Inc.|Digestive Disease Specialists Inc|Northwest Gastroenterology Clinic, Llc|Family Medical Associates, Research Department|Partners In Clinical Research, Llc|Clinical Trials Of South Carolina|Health Concepts|Wr-Clinsearch, Llc|Texas Clinical Research Institute, Llc|Advanced Research Institute, Inc.|Verity Research Inc.|Washington Gastroenterology Pllc|West Virginia University",{"$nulls":3},"Wieslaw (Wes) Bochenek, MD, PhD","2019-02-20","2020-05-25T16:40:19.039","2020-05-26T17:10:42.972","NCT03420781"]
["5ecbf4f2feab101b15530a4f","NCT03420781","2019-02-27","Allergan","AGN","Enrolling by invitation","A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis Study 03","Relamorelin","GHS-R Agonist","Yes","['Relamorelin']","Yes","['GHS-R Agonist']","Phase 3",3,960,"Anticipated","2018-01-24","2020-12-06",{"$nulls":5},"A 46-week study to compare the efficacy of relamorelin with that of placebo in participants with diabetic gastroparesis (DG). At the end of the 40-week Treatment Period, participants will either continue on relamorelin or placebo for 6 additional weeks.",null,"A 46-week, Double-blind, Placebo-controlled, Phase 3 Study With a 6-week Randomized-withdrawal Period to Evaluate the Safety and Efficacy of Relamorelin in Patients With Diabetic Gastroparesis","RLM-MD-03","Gastroparesis\nDiabetes Mellitus","Paresis|Gastroparesis","Neurologic Manifestations|Gastrointestinal Diseases","Central Nervous System|Gastrointestinal","Experimental","Relamorelin 10 Î¼g|Relamorelin 10 Î¼g, followed by Placebo|Placebo, followed by Relamorelin 10 Î¼g","Relamorelin 10 Î¼g injected subcutaneously twice daily for 46 weeks.|Relamorelin 10 Î¼g injected subcutaneously twice daily for 40 weeks, followed by placebo injected twice daily for 6 weeks.|Placebo injected subcutaneously twice daily for 40 weeks, followed by Relamorelin 10 Î¼g injected twice daily for 6 weeks.","Drug","Relamorelin|Placebo","Relamorelin 10 Î¼g injected twice daily for 6, 40 or 46 weeks.|Placebo injected twice daily for 6 weeks or 40 weeks.",null,"Relamorelin 10 Î¼g|Relamorelin 10 Î¼g, followed by Placebo|Placebo, followed by Relamorelin 10 Î¼g","\n\n * Participants are eligible to be included in the study only if all the following criteria apply:\n * Participant met all inclusion/exclusion criteria of either Protocol RLM-MD-01 (NCT03285308) or Protocol RLM-MD-02 (NCT03426345) and successfully completed the study\n * Able to provide written informed consent (IC) prior to any study procedures and willing and able to comply with study procedures\n * In the opinion of the investigator, the participant demonstrated adequate compliance with the study procedures in Study RLM-MD-01 or RLM-MD-02\n\n","\n\n * Participants are excluded from the study if any of the following criteria apply:\n * Participant is not willing or able to abide by the restrictions regarding concomitant medicine use\n * Participant is planning to receive an investigational drug (other than study treatment) or investigational device at any time during Study RLM-MD-03\n * Participant has an unresolved adverse event (AE) or a clinically significant finding on physical examination, clinical laboratory test, or 12-lead electrocardiogram (ECG) that, in the investigator's opinion, would limit the participant's ability to participate in or complete the study\n * Any other reason that, in the investigator's opinion, would confound proper interpretation of the study or expose a participant to unacceptable risk, including renal, hepatic or cardiopulmonary disease",{"$nulls":4},"Actual","2018-02-05","Actual","Anticipated","2020-12-06","Anticipated","2019-02-01","2018-01-24","2018-02-01","2019-02-26","No","diabetic gastroparesis\nvomiting","Interventional","Treatment","Parallel Assignment","Triple (Participant, Care Provider, Investigator)","Randomized","18 Years",null,"All",null,"No",{"$nulls":4},"Yes","No",{"$nulls":19},"Diabetic Gastroparesis Symptom Severity Score (DGSSS) Week-12 Responder|Percentage of patients meeting the vomiting symptom responder criterion in each of the last 6 of the 12 weeks of treatment","Patients will assess severity of diabetic gastroparesis symptoms daily using an 11-point ordinal scale with 0 being least and 10 being the worst possible score. Patients will enter the score using an electronic diary.|Vomiting episodes will be patient-recorded daily using an electronic diary.","Baseline to Week 12","Nausea Week 12 Responder|Abdominal Pain Week 12 Responder|Bloating Week 12 Responder|Postprandial Fullness Week 12 Responder|DGSSS Week 40 Responder|DGSSS at Week 40|Vomiting Frequency at Week 40|Vomiting Week-40 Responder|DGSSS at Week 46|Number of Vomiting Episodes at Week 46|Number of Patients who experienced one or more Treatment Emergent Adverse Event (TEAE)","Nausea responder defined as a participant who has at least a 2-point improvement in the weekly symptom score at each of the last 6 weeks of the first 12 weeks of the 40-week Treatment Period. Nausea is assessed on an 11-point ordinal scale from 0 to 10, with 0 meaning no nausea, and 10 meaning the worst possible nausea.|Abdominal pain responder defined as a participant who has at least a 2-point improvement in the weekly symptom score at each of the last 6 weeks of the first 12 weeks of the 40-week Treatment Period. Abdominal Pain is assessed on an 11-point ordinal scale from 0 to 10, with 0 meaning no abdominal Pain, and 10 meaning the worst possible abdominal pain.|Bloating responder defined as a participant who has at least a 2-point improvement in the weekly symptom score at each of the last 6 weeks of the first 12 weeks of the 40-week Treatment Period. Bloating is assessed on an 11-point ordinal scale from 0 to 10, with 0 meaning no bloating, and 10 meaning the worst possible bloating.|Postprandial Fullness responder defined as a participant who has at least a 2-point improvement in the weekly symptom score at each of the last 6 weeks of the first 12 weeks of the 40-week Treatment Period.\n\nPostprandial Fullness is assessed on an 11-point ordinal scale from 0 to 10, with 0 meaning no feeling of fullness until finishing a meal, and 10 meaning felling full after only a few bites.|DGSSS responder defined as a participant who has at least a 10-point improvement in the DGSSS compared to baseline in each of the last 4 weeks of the 40-week Treatment Period.|Change from baseline to Week 40 in average weekly DGSSS. Average weekly scores are derived as the average of the weekly scores from the four weeks prior to Week 40 (Visit 7) in this study.|Change from baseline to Week 40 in average weekly number of vomiting episodes derived as the average of the weekly number of vomiting episodes during the four weeks prior to Week 40 (Visit 7) in this study.|Vomiting responder defined as a participant with zero weekly vomiting episodes during each of the last 4 weeks of the 40-week Treatment Period.|Change from baseline (CFB) to end of Randomized withdrawl period (RWP) in the average weekly DGSSS. Average weekly scores are derived as the average of the weekly scores from the six weeks of the RWP.|CFB to end of RWP in the average weekly number of vomiting episodes. Average weekly scores are derived as the average of the weekly number of vomiting episodes from the six weeks of the RWP.|The number of patients who experienced one or more TEAE during the 46 week treatment period.","Baseline to Week 12|Baseline to Week 40|Baseline to Week 46",{"$nulls":3},{"$cut":{"chars":26151,"head":"Mar Del Plata, Buenos Aires, Argentina, B7600Fyk Ciad MoronMoron, Buenos Aires, Argentina, 1708|Buenos Aires, Ciudad Autonoma De Buenos Aires, Argentina, C1425Agc|Buenos Aires, Argentina, C1419Ahn Sanatorio GuemesCaba, Argentina, C1180 Aax CiprecCiudad Autonoma De Buenos Aires, Argentina, 1119 IlaimCordoba, Argentina, X5000Bnb Centro Universitario De Investigacion En Farmacologia ClinicCorrientes, Argentina, W3410Avv Instituto De Investigaciones Clinicas CbaCÃ³rdoba, Argentina, X5000Aaw|Rosario, Santa Fe, Argentina, 2000 Instituto De Hematologia Y Medicina Clinica Dr. Ruben DavoliRosario, Santa Fe, Argentina, S200Cfk|San Miguel De Tucuman, Tucuman, Argentina, 4000|Kingswood, New South Wales, Australia, 2747|Woolloongabba, Queensland, Australia, 4102|Adelaide, South|Melbourne, Victoria, Australia, 3004 Royal Melbourne HospitalParkville, Victoria, Australia, 3050|Klagenfurt, Austria, 9020 Privatklinik Wehrle-DiakonissenSalzburg, Austria, 5020 Gesundheits- Und Spitals-Ag/Lkh SteyrSteyr, Austria, 4400|Sankt Stefan Ob Stainz, Styria, Austria, 8511|Innsbruck, Tirol, Austria, A-6020|Feldkirch`, Vorarlberg, Austria, 6807|Edegem, Antwerp, Belgium, 2650|Jette, Brussel, Belgium, 1090|Brussels, Belgium, 1070|Brugge, West-Vlaanderen, Belgium, 8310|Fortaleza, Ceara, Brazil, 60160-230 Hospital Universitario Walter CantadioFortaleza, Ceara, Brazil, 60430270|Sao Paulo, Brazil, 01228-000 Universidade De Sao Paulo (Usp) - Hospital Das Clinicas Da FSao Paulo, Brazil, 5403000 Instituto De Pesquisa ClÃ­nica E Medicina Avancada LtdaSÃ£o Paulo, Brazil, 01223-001|Brasilia, Distrito Federal, Brazil, 71625175|BelÃ©m, Para, Brazil, 66073-000|Curitiba, Parana, Brazil, 80030-110|BelÃ£Â©M, ParÃ£Â¡, Brazil, 66073-000|Passo Fundo, Rio Grande Do Sul, Brazil, 99010-080 Hospital De Clinicas De Porto AlegrePorto Alegre, Rio Grande Do Sul, Brazil, 90035-003 Hospital Sao Lucas Da Puc-RsPorto Alegre, Rio Grande Do Sul, Brazil, 90610-000|FlorianÃ³polis, Santa Catarina, Brazil, 88015-230 Instituto Catarinense De Endocrinologia E Diabetes (Iced)Joinville, Santa Catarina, Brazil, 89201-260|Campinas, Sao Paulo, Brazil, 13060904|Campinas, SÃ£o Paulo, Brazil, 13020-431|Byala, Ruse, Bulgaria, 7100|Plovdiv, Bulgaria, 4002 Medical Center Asklepion - Humane Medicine Research EoodSofia, Bulgaria, 1303 Alexandrovska University HospitalSofia, Bulgaria, 1431|Calgary, Alberta, Canada, T2N 2T9 Alberta Diabetes InstituteEdmonton, Alberta, Canada, T6G 2E1 The Bailey ClinicRed Deer, Alberta, Canada, T4N 6V7|Vancouver, British Columbia, Canada, V5Z 1M9|St. John'S, Newfoundland And Labrador, Canada, A1B 3V6|Bridgewater, Nova Scotia, Canada, B4V 2V6|Ottawa, Ontario, Canada, K1H 7W9 Sunnybrook Health Science CentreToronto, Ontario, Canada, M4N 3M5 Toronto Western Hospital, University Health NetworkToronto, Ontario, Canada, M5T 2S8 Toronto Liver CentreToronto, Ontario, Canada, M6H 3M1 Toronto Digestive Disease Associates, Inc.Vaughan, Ontario, Canada, L4L 4Y7|Greenfield Park, Quebec, Canada, J4V 2H1 Recherche Gcp ResearchMontreal, Quebec, Canada, H1M 1B1 Centre Hospitalier De L'Universite De Montreal - ChumMontreal, Quebec, Canada, H2X 0A9|Medellin, Antioquia, Colombia, 050034 Ips Rodrigo Botero SasMedellÃ­n, Antioquia, Colombia, 050030|Barranquilla, Atlantico, Colombia, 080020 Fundacion BiosBarranquilla, Atlantico, Colombia, 080020|BogotÃ¡, Cundinamarca, Colombia, 111111 Healthy Medical CenterZipaquira, Cundinamarca, Colombia, 250252|Bogota, Distrito Capital De Bogota, Colombia, 110221|Teusaquillo, Distrito Capital De BogotÃ¡, Colombia, 111311|Villavicencio, Meta, Colombia, 500001|Pereira, Risaralda, Colombia, 660002 Fundacion Centro De Investigaciones Clinicas CardiometPereira, Risaralda, Colombia, Not Yet Recruiting|Cali, Valle Del Cauca, Colombia, 760001 Ips Centro Medico Julian Coronel S.ACali, Valle Del Cauca, Colombia, 760035|Aalborg, Denmark, 9000|Hellerup, Copenhagen, Denmark, 2900 Gastroenheden, Hvidovre HospitalHvidovre, Copenhagen, Denmark, 2650|Corbeil Essonnes Cedex, France, 91106 GrenobleGrenoble, France, 38043 Hospices Civils De Lyon - HÃ£Â´Pital Edouard HerrriotLyon C"}},"Alabama|Arizona|Arkansas|California|Colorado|Connecticut|Florida|Georgia|Idaho|Illinois|Indiana|Iowa|Kansas|Kentucky|Louisiana|Maryland|Massachusetts|Michigan|Montana|Nebraska|Nevada|New Jersey|New Mexico|New York|North Carolina|Ohio|Oklahoma|Oregon|Pennsylvania|Rhode Island|South Carolina|South Dakota|Tennessee|Texas|Utah|Virginia|Washington|West Virginia","Argentina|Australia|Austria|Belgium|Brazil|Bulgaria|Canada|Colombia|Denmark|France|Germany|Hungary|India|Israel|Italy|Latvia|Malaysia|Mexico|Philippines|Poland|Romania|South Africa|Spain|Thailand|Ukraine|United Kingdom|United States","Buenos Aires Centro De Investigaciones Medicas Mar Del Plata Srl|Ciudad Autonoma De Buenos Aires Consultorios Asociados De Endocrinologia E Investigacion Cl|Hospital Sirio Libanes|Santa Fe Instituto De Investigaciones Clinicas De Rosario|Tucuman Centro Modelo De Cardiologia|New South Wales Nepean Hospital|Queensland Princess Alexandra Hospital|Royal Adelaide Hospital|Victoria The Alfred Hospital|Klinikum Klagenfurt Am WÃ£Â¶Rthersee|Styria Ordination|Tirol Medizinische Universitat Innsbruck|Vorarlberg Vivit Institute, Am Lkh Feldkirch|Antwerp Universitair Ziekenhuis Antwerpen, Gastro-Enterologie,|Brussel Uz Brussel|Hopitaux Iris Sud - Joseph Bracops|West-Vlaanderen Az Sint Lucas Brugge|Ceara Instituto De Estudos E Pesquisas Clinicas Do Ceara Iep/Ce - Oncology|Cpquali Pesquisa Clinica Ltda|Distrito Federal Centro De Pesquisa Clinica Do Brasil|Para Hospital Universitario Joao De Barros Barreto - Ufpa|Parana Ceti - Centro De Estudos Em Terapias Inovadoras|ParÃ£Â¡ Hospital UniversitÃ£Â¡Rio JoÃ£Â£O De Barros Barreto - Ufpa|Rio Grande Do Sul Hospital Sao Vicente De Paulo|Santa Catarina Noova|Sao Paulo Instituto De Pesquisa Clinica De Campinas|SÃ£o Paulo Scentryphar Pesquisa Clinica Ltda|Ruse Mhat Yuliya Vrevska Byala|Umhat - Kaspela- Eood|Alberta University Of Calgary|British Columbia Gordon And Leslie Diamond Health Care Centre|Newfoundland And Labrador Eastern Health|Nova Scotia South Shore Medical Arts|Ontario The Ottawa Hospital|Quebec Cisss De La Monteregie-Centre|Antioquia Centro Cardiovascular Colombiano ClÃ­nica Santa MarÃ­a|Atlantico Centro Cardiovascular Y De Diabetes|Cundinamarca Endocare Ltda.|Distrito Capital De Bogota Medplus Medicina Prepagada|Distrito Capital De BogotÃ¡ AsociaciÃ³n Colombiana De Diabetes|Meta Clinica Meta|Risaralda Fundacion Centro De Investigaciones Clinicas Cardiomet|Valle Del Cauca Centro Medico Imbanaco De Cali S.A.|Aalborg University Hospital|Copenhagen Gentofte Hospital|Corbeil Essonnes|Gironde Chu De Bordeaux - HÃ£Â´Pital Haut-LÃ£Â©VÃ£Âªque|Grand Est Chru Nancy|Hopital Louis Mourier, Service D'Hepato Gastro-Enterologie|Baden-WÃ£Â¼Rttemberg Klinische Forschung Karlsruhe Gmbh|Diabetologische Schwerpunktpraxis|Mecklenburg Vorpommern Klinische Forschung Schwerin Gmbh|Niedersachsen Klinische Forschung Hannover-Mitte Gmbh|Saxony Studienzentrum Schwittay|CsonfrÃ£Â¡D First Department Of Medicine, University Of Szeged|Heves Markhot Ferenc Oktatokorhaz Es Rendelointezet|JÃ¡sz-Nagykun-Szolnok Hetenyi Geza Hospital|StrÃ£Æ’Ã¢Â¡Zshegy Medicina|Zala Zala Megyei Szent Rafael Korhaz|Andhra Pradesh Kumudini Devi Diabetes Research Center; Ramdevrao Hospital|Gujarat Dr. Jivraj Mehta Smarak Health Foundation Bakeri Medical Research Centre - Gasterentrology|Karnataka Victoria Hospital Bangalore Medical College And Research Institute|Maharashtra Bhatia Hospital|Rajasthan Sms Hospital|Sir Ganga Ram Hospital|Tamil Nadu M.V. Hospital For Diabetes & Diabetes Research Centre|Uttar Prandesh M V Hospital & Research Centre|Soroka University Medical Center|Lombardy Humanitas Research Hospital|Milan Irccs Policlinico San Donato|Ospedale Cardinal Massaia|Sicily Azienda Ospedaliera Rilievo Nazionale Alta Specialita (Arnas) Garibaldi|Kraslavas Nov. Ogorelova Jelena Gp|Polana-D, Llc|Kedah Hospital Sultanah Bahiyah|Selangor University Malaya Medical Centre, Lembah Pantai|Guanajuato Morales Vargas Centro De Investigacion Sc|Guillermina Hospital De La Paz|Hidalgo Resultados Medicos Desarrollo E Investigacion S.C|Jalisco Consultorio Medico|Morelos Not Yet Instituto De Diabetes Obesidad Y Nutricion Sc|Nuevo Leon Accelerium S. De R.L. De C.V.|Practice Dr Gerardo Gonzalez|Tlalpan Instituto Nacional De Ciencias Medicas Y Nutricion Salvador Zubiran|Veracruz Centro Especializado En Investigacion Clinica S.C.|YucatÃ¡n ClÃ­nica De MÃ©rida|Iloilo West Visayas State University Medical Center|Metro Manila St. Luke's Medical Center|Metropolitan Manila Manila Doctors Hospital, Ermita|Ncr Ospital Ng Makati|Perpetual Succor Hospital|Lublin ZamoÅ›Ä‡|Malopolska Centermed Krakow Ltd|Masovian Oddzial Gastroenterologii Mazowieckie Centrum Rehabilitacji Stocer Sp. Z O.O.|Podlaski Diabet-Med|Podlaskie University Hospital BiaÅ‚ystok|Pomorskie Endoskopia Sp. Z O.O.|Powiatowe Centrum Medyczne W Wolowie Sp. Z O.O.|Specjalistyczny Gabinet Neurologiczny Marta Banach|Warmia-Mazury State Hospital|Oltenia Clintrial Medical Center, Pulmonology Department|Sana Medical Center|, Free State Farmovs|, Gauteng Wits Clinical Research|Synexus Helderberg Clinical Research Centre|Hospital Clinico Universitario San Carlos|Phramongkutklao Hospital|\"|Chernihiv City Hospital No 2 Of Chernihiv City Council|Dnipropetrovsk City Hospital 3|Odesa Region Odesa Regional Clinical Hospital|On The Base Of Pirogov National Medical University|Zaporizhzhia Region Municipal Institution City Hospital No. 7|, East Midland Queens Medical Centre|, Greater Manchester Mac Clinical Research Manchester|, Lancashire Royal Oldham Hospital|, Staffordshire Mac Research, Exchange House|, West Midlands Royal Wolverhampton Nhs Trust|, West Yorkshire Mac Clinical Research, Monarch House|Mac Research|North Alabama Research Center, Llc|Del Sol Research Management, Llc|Chi St. Vincent's Gastroenterology: John Tyler Baber, Md|Hope Clinical Research|University Of Colorado, Denver|Gastroenterology Associates Of Fairfield County, P.C.|Innovative Research Of West Fl, Inc.|Atlanta Diabetes Associates|Rocky Mountain Diabetes And Osteoporosis Center, Pa|North Shore University Health System|Medisphere Medical Research Center, Llc|University Of Iowa Hospitals And Clinics|University Of Kansas Medical Center|Tri-State Gastroenterology|The Center For Clinical Research|Metropolitan Gastroenterology Group Pc, Chevy Chase Clinical Research|Commonwealth Clinical Studies, Pllc.|Clinical Research Institute Of Michigan|Montana Medical Research|Diabetes And Endocrine Associates, P.C.|Clinical Research Of South Nevada - Crosn|Garden State Endocrinology|Lovelace Scientific Resources, Inc.|Long Island Gastrointestinal Research Group Llp|Asheville Gastroenterology Associates|Dayton Gastroenterology,Inc.|Digestive Disease Specialists Inc|Northwest Gastroenterology Clinic, Llc|Family Medical Associates, Research Department|Partners In Clinical Research, Llc|Clinical Trials Of South Carolina|Health Concepts|Wr-Clinsearch, Llc|Texas Clinical Research Institute, Llc|Advanced Research Institute, Inc.|Verity Research Inc.|Washington Gastroenterology Pllc|West Virginia University",{"$nulls":3},"Wieslaw (Wes) Bochenek, MD, PhD","2019-02-26","2020-05-25T16:40:18.978","2020-05-26T17:10:42.972","NCT03420781"]
["5ecbf4f3307e3d1b1f8d9eb2","NCT03420781","2019-06-11","Allergan","AGN","Enrolling by invitation","A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis Study 03","Relamorelin","GHS-R Agonist","Yes","['Relamorelin']","Yes","['GHS-R Agonist']","Phase 3",3,960,"Anticipated","2018-01-24","2020-12-06",{"$nulls":5},"A 46-week study to compare the efficacy of relamorelin with that of placebo in participants with diabetic gastroparesis (DG). At the end of the 40-week Treatment Period, participants will either continue on relamorelin or placebo for 6 additional weeks.",null,"A 46-week, Double-blind, Placebo-controlled, Phase 3 Study With a 6-week Randomized-withdrawal Period to Evaluate the Safety and Efficacy of Relamorelin in Patients With Diabetic Gastroparesis","RLM-MD-03","Gastroparesis\nDiabetes Mellitus","Paresis|Gastroparesis","Neurologic Manifestations|Gastrointestinal Diseases","Central Nervous System|Gastrointestinal","Experimental","Relamorelin 10 Î¼g|Relamorelin 10 Î¼g, followed by Placebo|Placebo, followed by Relamorelin 10 Î¼g","Relamorelin 10 Î¼g injected subcutaneously twice daily for 46 weeks.|Relamorelin 10 Î¼g injected subcutaneously twice daily for 40 weeks, followed by placebo injected twice daily for 6 weeks.|Placebo injected subcutaneously twice daily for 40 weeks, followed by Relamorelin 10 Î¼g injected twice daily for 6 weeks.","Drug","Relamorelin|Placebo","Relamorelin 10 Î¼g injected twice daily for 6, 40 or 46 weeks.|Placebo injected twice daily for 6 weeks or 40 weeks.",null,"Relamorelin 10 Î¼g|Relamorelin 10 Î¼g, followed by Placebo|Placebo, followed by Relamorelin 10 Î¼g"," * Participants are eligible to be included in the study only if all the following criteria apply:\n * Participant met all inclusion/exclusion criteria of either Protocol RLM-MD-01 (NCT03285308) or Protocol RLM-MD-02 (NCT03426345) and successfully completed the study\n * Able to provide written informed consent (IC) prior to any study procedures and willing and able to comply with study procedures\n * In the opinion of the investigator, the participant demonstrated adequate compliance with the study procedures in Study RLM-MD-01 or RLM-MD-02\n\n"," * Participants are excluded from the study if any of the following criteria apply:\n * Participant is not willing or able to abide by the restrictions regarding concomitant medicine use\n * Participant is planning to receive an investigational drug (other than study treatment) or investigational device at any time during Study RLM-MD-03\n * Participant has an unresolved adverse event (AE) or a clinically significant finding on physical examination, clinical laboratory test, or 12-lead electrocardiogram (ECG) that, in the investigator's opinion, would limit the participant's ability to participate in or complete the study\n * Any other reason that, in the investigator's opinion, would confound proper interpretation of the study or expose a participant to unacceptable risk, including renal, hepatic or cardiopulmonary disease ",{"$nulls":4},"Actual","2018-02-05","Actual","Anticipated","2020-12-06","Anticipated","2019-06-01","2018-01-24","2018-02-01","2019-06-07",null,"diabetic gastroparesis\nvomiting","Interventional","Treatment","Parallel Assignment","Triple (Participant, Care Provider, Investigator)","Randomized","18 Years",null,"All",null,"No",null,null,"URL: http://www.investigatordatabank.org/ [http://www.investigatordatabank.org/] Exit Disclaimer; please review our Privacy Policy [html/images/Icon_External_Link.png] [https://www.nlm.nih.gov/privacy.html]\nDescription: To be considered as a site for current and future Allergan Clinical Trials, please register using the Investigator Databank link.",null,"Yes","No",{"$nulls":19},"Change from Baseline to Week 12 of this study in the weekly Diabetic Gastroparesis Symptom Severity Score (DGSSS)|Percentage of patients meeting the vomiting symptom responder criterion in each of the last 6 weeks of the first 12 week Treatment Period","Patients will assess severity of diabetic gastroparesis symptoms daily using an 11-point ordinal scale with 0 being least and 10 being the worst possible score. Patients will enter the score using an electronic diary.|Vomiting episodes will be patient-recorded daily using an electronic diary.","Baseline to Week 12","Nausea Week 12 Responder|Abdominal Pain Week 12 Responder|Bloating Week 12 Responder|Postprandial Fullness Week 12 Responder|DGSSS at Week 40|Vomiting Frequency at Week 40|Vomiting Week-40 Responder|DGSSS at Week 46|Number of Vomiting Episodes at Week 46|Number of Patients who experienced one or more Treatment Emergent Adverse Event (TEAE)","Nausea responder defined as a participant who has at least a 2-point improvement in the weekly symptom score at each of the last 6 weeks of the first 12 weeks of the 40-week Treatment Period. Nausea is assessed on an 11-point ordinal scale from 0 to 10, with 0 meaning no nausea, and 10 meaning the worst possible nausea.|Abdominal pain responder defined as a participant who has at least a 2-point improvement in the weekly symptom score at each of the last 6 weeks of the first 12 weeks of the 40-week Treatment Period. Abdominal Pain is assessed on an 11-point ordinal scale from 0 to 10, with 0 meaning no abdominal Pain, and 10 meaning the worst possible abdominal pain.|Bloating responder defined as a participant who has at least a 2-point improvement in the weekly symptom score at each of the last 6 weeks of the first 12 weeks of the 40-week Treatment Period. Bloating is assessed on an 11-point ordinal scale from 0 to 10, with 0 meaning no bloating, and 10 meaning the worst possible bloating.|Postprandial Fullness responder defined as a participant who has at least a 2-point improvement in the weekly symptom score at each of the last 6 weeks of the first 12 weeks of the 40-week Treatment Period.\n\nPostprandial Fullness is assessed on an 11-point ordinal scale from 0 to 10, with 0 meaning no feeling of fullness until finishing a meal, and 10 meaning felling full after only a few bites.|Change from baseline to Week 40 in average weekly DGSSS. Average weekly scores are derived as the average of the weekly scores from the four weeks prior to Week 40 (Visit 7) in this study.|Change from baseline to Week 40 in average weekly number of vomiting episodes derived as the average of the weekly number of vomiting episodes during the four weeks prior to Week 40 (Visit 7) in this study.|Vomiting responder defined as a participant with zero weekly vomiting episodes during each of the last 4 weeks of the 40-week Treatment Period.|Change from baseline (CFB) to end of Randomized withdrawl period (RWP) in the average weekly DGSSS. Average weekly scores are derived as the average of the weekly scores from the six weeks of the RWP.|CFB to end of RWP in the average weekly number of vomiting episodes. Average weekly scores are derived as the average of the weekly number of vomiting episodes from the six weeks of the RWP.|The number of patients who experienced one or more TEAE during the 46 week treatment period.","Baseline to Week 12|Baseline to Week 40|Baseline to Week 46",{"$nulls":3},{"$cut":{"chars":27627,"head":"Mar Del Plata, Buenos Aires, Argentina, B7600Fyk Ciad MoronMoron, Buenos Aires, Argentina, 1708|Buenos Aires, Ciudad Autonoma De Buenos Aires, Argentina, C1425Agc|Buenos Aires, Argentina, C1419Ahn Sanatorio GuemesCaba, Argentina, C1180 Aax CiprecCiudad Autonoma De Buenos Aires, Argentina, 1119 IlaimCordoba, Argentina, X5000Bnb Centro Universitario De Investigacion En Farmacologia ClinicCorrientes, Argentina, W3410Avv Instituto De Investigaciones Clinicas CbaCÃ³rdoba, Argentina, X5000Aaw|Rosario, Santa Fe, Argentina, 2000 Instituto De Hematologia Y Medicina Clinica Dr. Ruben DavoliRosario, Santa Fe, Argentina, S200Cfk|San Miguel De Tucuman, Tucuman, Argentina, 4000|Kingswood, New South Wales, Australia, 2747|Woolloongabba, Queensland, Australia, 4102|Adelaide, South|Melbourne, Victoria, Australia, 3004 Royal Melbourne HospitalParkville, Victoria, Australia, 3050|Klagenfurt, Austria, 9020 Privatklinik Wehrle-DiakonissenSalzburg, Austria, 5020 OÃ¶. Gesundheits- Und Spitals-Ag/Lkh SteyrSteyr, Austria, 4400|Sankt Stefan Ob Stainz, Styria, Austria, 8511|Innsbruck, Tirol, Austria, A-6020|Feldkirch`, Vorarlberg, Austria, 6807|Edegem, Antwerp, Belgium, 2650|Jette, Brussel, Belgium, 1090|Brussels, Belgium, 1070|Brugge, West-Vlaanderen, Belgium, 8310|Fortaleza, Ceara, Brazil, 60160-230 Hospital Universitario Walter CantadioFortaleza, Ceara, Brazil, 60430270|Brasilia, Distrito Federal, Brazil, 71625175|BelÃ©m, Brazil, 66073-000 Cpquali Pesquisa Clinica LtdaSao Paulo, Brazil, 01228-000 Hospital De ClÃ­nicas Da Fmusp - Centro De Pesquisas ClÃ­nicasSao Paulo, Brazil, 5403000 Instituto De Pesquisa ClÃ­nica E Medicina Avancada LtdaSÃ£o Paulo, Brazil, 01223-001|Curitiba, Parana, Brazil, 80030-110|Passo Fundo, Rio Grande Do Sul, Brazil, 99010-080 NÃºcleo De Pesquisa ClÃ­nica Do Rio Grande Do SulPorto Alegre, Rio Grande Do Sul, Brazil, 90430-001 Hospital Sao Lucas Da Puc-RsPorto Alegre, Rio Grande Do Sul, Brazil, 90610-000|FlorianÃ³polis, Santa Catarina, Brazil, 88015-230 Instituto Catarinense De Endocrinologia E Diabetes (Iced)Joinville, Santa Catarina, Brazil, 89201-260|Campinas, Sao Paulo, Brazil, 13060904|Campinas, SÃ£o Paulo, Brazil, 13020-431|Byala, Ruse, Bulgaria, 7100|Plovdiv, Bulgaria, 4002 Medical Center Asklepion - Humane Medicine Research EoodSofia, Bulgaria, 1303 Alexandrovska University HospitalSofia, Bulgaria, 1431|Calgary, Alberta, Canada, T2N 2T9 Alberta Diabetes InstituteEdmonton, Alberta, Canada, T6G 2E1 The Bailey ClinicRed Deer, Alberta, Canada, T4N 6V7|Vancouver, British Columbia, Canada, V5Z 1M9|St. John'S, Newfoundland And Labrador, Canada, A1B 3V6|Bridgewater, Nova Scotia, Canada, B4V 2V6|Ottawa, Ontario, Canada, K1H 7W9 Sunnybrook Health Science CentreToronto, Ontario, Canada, M4N 3M5 Toronto Western Hospital, University Health NetworkToronto, Ontario, Canada, M5T 2S8 Toronto Liver CentreToronto, Ontario, Canada, M6H 3M1 Toronto Digestive Disease Associates, Inc.Vaughan, Ontario, Canada, L4L 4Y7|Greenfield Park, Quebec, Canada, J4V 2H1 Recherche Gcp ResearchMontreal, Quebec, Canada, H1M 1B1 Centre Hospitalier De L'Universite De Montreal - ChumMontreal, Quebec, Canada, H2X 0A9|Medellin, Antioquia, Colombia, 050034 Ips Rodrigo Botero SasMedellÃ­n, Antioquia, Colombia, 050030|Barranquilla, Atlantico, Colombia, 080020 Fundacion BiosBarranquilla, Atlantico, Colombia, 080020|BogotÃ¡, Cundinamarca, Colombia, 111111 Healthy Medical CenterZipaquira, Cundinamarca, Colombia, 250252|Bogota, Distrito Capital De Bogota, Colombia, 110221|Teusaquillo, Distrito Capital De BogotÃ¡, Colombia, 111311|Villavicencio, Meta, Colombia, 500001|Pereira, Risaralda, Colombia, 660002 Fundacion Centro De Investigaciones Clinicas CardiometPereira, Risaralda, Colombia, Not Yet Recruiting|Cali, Valle Del Cauca, Colombia, 760001 Ips Centro Medico Julian Coronel S.ACali, Valle Del Cauca, Colombia, 760035|Aalborg, Denmark, 9000|Hellerup, Copenhagen, Denmark, 2900 Gastroenheden, Hvidovre HospitalHvidovre, Copenhagen, Denmark, 2650|Corbeil Essonnes Cedex, France, 91106 GrenobleGrenoble, France, 38043 Hospices Civils De Lyon - HÃ´pital Edouard HerrriotLy"}},"Alabama|Arizona|Arkansas|California|Colorado|Connecticut|Florida|Georgia|Idaho|Illinois|Indiana|Iowa|Kansas|Kentucky|Louisiana|Maryland|Massachusetts|Michigan|Minnesota|Montana|Nebraska|Nevada|New Jersey|New Mexico|New York|North Carolina|Ohio|Oklahoma|Oregon|Pennsylvania|Rhode Island|South Carolina|South Dakota|Tennessee|Texas|Utah|Virginia|Washington|West Virginia","Argentina|Australia|Austria|Belgium|Brazil|Bulgaria|Canada|Colombia|Denmark|France|Germany|Hungary|India|Israel|Italy|Latvia|Malaysia|Mexico|Philippines|Poland|Romania|South Africa|Spain|Thailand|Ukraine|United Kingdom|United States","Buenos Aires Centro De Investigaciones Medicas Mar Del Plata Srl|Ciudad Autonoma De Buenos Aires Consultorios Asociados De Endocrinologia E Investigacion Cl|Hospital Sirio Libanes|Santa Fe Instituto De Investigaciones Clinicas De Rosario|Tucuman Centro Modelo De Cardiologia|New South Wales Nepean Hospital|Queensland Princess Alexandra Hospital|Royal Adelaide Hospital|Victoria The Alfred Hospital|Klinikum Klagenfurt Am WÃ£Â¶Rthersee|Styria Ordination|Tirol Medizinische Universitat Innsbruck|Vorarlberg Vivit Institute, Am Lkh Feldkirch|Antwerp Universitair Ziekenhuis Antwerpen, Gastro-Enterologie,|Brussel Uz Brussel|Hopitaux Iris Sud - Joseph Bracops|West-Vlaanderen Az Sint Lucas Brugge|Ceara Instituto De Estudos E Pesquisas Clinicas Do Ceara Iep/Ce - Oncology|Distrito Federal Centro De Pesquisa Clinica Do Brasil|Hospital UniversitÃ¡rio JoÃ£o De Barros Barreto|Parana Ceti - Centro De Estudos Em Terapias Inovadoras|Rio Grande Do Sul Hospital Sao Vicente De Paulo|Santa Catarina Noova|Sao Paulo Instituto De Pesquisa Clinica De Campinas|SÃ£o Paulo Scentryphar Pesquisa Clinica Ltda|Ruse Mhat Yuliya Vrevska Byala|Umhat - Kaspela- Eood|Alberta University Of Calgary|British Columbia Gordon And Leslie Diamond Health Care Centre|Newfoundland And Labrador Eastern Health|Nova Scotia South Shore Medical Arts|Ontario The Ottawa Hospital|Quebec Cisss De La Monteregie-Centre|Antioquia Centro Cardiovascular Colombiano ClÃ­nica Santa MarÃ­a|Atlantico Centro Cardiovascular Y De Diabetes|Cundinamarca Endocare Ltda.|Distrito Capital De Bogota Medplus Medicina Prepagada|Distrito Capital De BogotÃ¡ AsociaciÃ³n Colombiana De Diabetes|Meta Clinica Meta|Risaralda Fundacion Centro De Investigaciones Clinicas Cardiomet|Valle Del Cauca Centro Medico Imbanaco De Cali S.A.|Aalborg University Hospital|Copenhagen Gentofte Hospital|Corbeil Essonnes|Gironde Chu De Bordeaux - HÃ£Â´Pital Haut-LÃ£Â©VÃ£Âªque|Grand Est Chru Nancy|Hopital Louis Mourier, Service D'Hepato Gastro-Enterologie|Baden-WÃ£Â¼Rttemberg Klinische Forschung Karlsruhe Gmbh|Diabetologische Schwerpunktpraxis|Mecklenburg Vorpommern Klinische Forschung Schwerin Gmbh|Niedersachsen Klinische Forschung Hannover-Mitte Gmbh|Saxony Studienzentrum Schwittay|CsonfrÃ£Â¡D First Department Of Medicine, University Of Szeged|Heves Markhot Ferenc Oktatokorhaz Es Rendelointezet|JÃ¡sz-Nagykun-Szolnok Hetenyi Geza Hospital|StrÃ£Æ’Ã¢Â¡Zshegy Medicina|Zala Zala Megyei Szent Rafael Korhaz|Andhra Pradesh Kumudini Devi Diabetes Research Center; Ramdevrao Hospital|Gujarat Dr. Jivraj Mehta Smarak Health Foundation Bakeri Medical Research Centre - Gasterentrology|Karnataka Victoria Hospital Bangalore Medical College And Research Institute|Maharashtra Bhatia Hospital|Rajasthan Sp Medical College|Sir Ganga Ram Hospital|Tamil Nadu M.V. Hospital For Diabetes & Diabetes Research Centre|Uttar Prandesh M V Hospital & Research Centre|Soroka University Medical Center|Lombardy Humanitas Research Hospital|Milan Irccs Policlinico San Donato|Ospedale Cardinal Massaia|Sicily Azienda Ospedaliera Rilievo Nazionale Alta Specialita (Arnas) Garibaldi|Kraslavas Nov. Ogorelova Jelena Gp|Polana-D, Llc|Kedah Hospital Sultanah Bahiyah|Selangor University Malaya Medical Centre, Lembah Pantai|Guanajuato Morales Vargas Centro De Investigacion Sc|Guillermina Centro De InvestigaciÃ³n Y AtenciÃ³n De Diabetes - EndocrinologÃ­a Y NutriciÃ³n|Hidalgo Centro De Diabetes De Pachuca|Jalisco Unidad De Investigacion Clinica Cardiometabolica De Occidente, S.C.|Morelos Not Yet Instituto De Diabetes Obesidad Y Nutricion Sc|Nuevo Leon Accelerium S. De R.L. De C.V.|Practice Dr Gerardo Gonzalez|Tlalpan Instituto Nacional De Ciencias Medicas Y Nutricion Salvador Zubiran|Veracruz Centro Especializado En Investigacion Clinica S.C.|YucatÃ¡n Centro De Desarrollo Biomedico S.C.P.|Iloilo West Visayas State University Medical Center|Metro Manila St. Luke's Medical Center|Metropolitan Manila Manila Doctors Hospital, Ermita|Ncr Ospital Ng Makati|Perpetual Succor Hospital|Lublin ZamoÅ›Ä‡|Malopolska Centermed Krakow Ltd|Masovian Oddzial Gastroenterologii Mazowieckie Centrum Rehabilitacji Stocer Sp. Z O.O.|Podlaski Nzoz Vita - Diabetica Malgorzata Buraczyk, Diabetes Clinic|Podlaskie University Hospital BiaÅ‚ystok|Pomorskie Endoskopia Sp. Z O.O.|Powiatowe Centrum Medyczne W Wolowie Sp. Z O.O.|Specjalistyczny Gabinet Neurologiczny Marta Banach|Warmia-Mazury Wojewodzki Szpital Specjalistyczny W Olsztynie|Oltenia Clintrial Medical Center, Pulmonology Department|Sana Medical Center|, Free State Farmovs|, Gauteng Wits Clinical Research|, Val-De-Grace Watermeyer Clinical Research Site|Synexus Helderberg Clinical Research Centre|Hospital Clinico Universitario San Carlos|Phramongkutklao Hospital|\"|Chernihiv City Hospital No 2 Of Chernihiv City Council|Dnipropetrovsk City Hospital 3|Odesa Region Odesa Regional Clinical Hospital|On The Base Of Pirogov National Medical University|Zaporizhzhia Region Municipal Institution City Hospital No. 7|, East Midland Queens Medical Centre|, Greater Manchester Mac Clinical Research Manchester|, Lancashire Royal Oldham Hospital|, Staffordshire Mac Research, Exchange House|, West Midlands Royal Wolverhampton Nhs Trust|, West Yorkshire Mac Clinical Research, Monarch House|Mac Research|Pinnacle Research Group|Del Sol Research Management, Llc|Chi St. Vincent's Gastroenterology: John Tyler Baber, Md|Hope Clinical Research|University Of Colorado, Denver|Gastroenterology Associates Of Fairfield County, P.C.|Visionary Investigators Network|Atlanta Diabetes Associates|Northwest Clinical Trials, Inc.|North Shore University Health System|Medisphere Medical Research Center, Llc|University Of Iowa Hospitals And Clinics|University Of Kansas Medical Center|Tri-State Gastroenterology|The Center For Clinical Research|Trialspark - Silverman|Commonwealth Clinical Studies, Pllc.|Clinical Research Institute Of Michigan|Minnesota Gastroenterology, P.A.|Montana Medical Research|Diabetes And Endocrine Associates, P.C.|Clinical Research Of South Nevada - Crosn|Garden State Endocrinology|Lovelace Scientific Resources, Inc.|Asheville Gastroenterology Associates|Dayton Gastroenterology,Inc.|Digestive Disease Specialists Inc|Northwest Gastroenterology Clinic, Llc|Family Medical Associates, Research Department|Partners In Clinical Research, Llc|Clinical Trials Of South Carolina|Health Concepts|Wr-Clinsearch, Llc|Texas Clinical Research Institute, Llc|Advanced Research Institute, Inc.|Verity Research Inc.|Washington Gastroenterology Pllc|West Virginia University",{"$nulls":3},"Harvy Schneier","2019-06-07","2020-05-25T16:40:19.532","2020-05-26T17:10:42.972","NCT03420781"]